id|nct_id|outcome_id|non_inferiority_type|non_inferiority_description|param_type|param_value|dispersion_type|dispersion_value|p_value_modifier|p_value|ci_n_sides|ci_percent|ci_lower_limit|ci_upper_limit|ci_upper_limit_na_comment|p_value_description|method|method_description|estimate_description|groups_description|other_analysis_description|ci_upper_limit_raw|ci_lower_limit_raw|p_value_raw
71700226|NCT03675308|142916254|SUPERIORITY||Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.0|30.0||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of baseline psoriasis (≥ 3%/\< 3% body surface area), presence of dactylitis (yes/no), presence of enthesitis (yes/no) and current csDMARD use (0/≥ 1).||30.0|18.0|<0.001
71761376|NCT01077050|143024232|SUPERIORITY_OR_OTHER||Sensitivity to Melanoma|96.6|||||ONE_SIDED|95.0|94.2|||The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.|Clopper-Pearson 1-sided||||||94.2|
71761377|NCT01077050|143024232|SUPERIORITY_OR_OTHER||Sensitivity to Basal Cell Carcinoma|100.0|||||TWO_SIDED|95.0|92.6|100.0|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for Basal Cell Carcinoma||||100|92.6|
71761378|NCT01077050|143024232|SUPERIORITY_OR_OTHER||Observed sensitivity for squamous cell c|93.3|||||TWO_SIDED|95.0|68.1|99.8|||Clopper-Pearson 2-sided|Point estimate of the observed sensitivity for squamous cell carcinoma||||99.8|68.1|
71761379|NCT01077050|143024232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.0|||<|0.0001|TWO_SIDED|95.0|6.6|25.5|||Mixed Models Analysis|Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.||||25.5|6.6|<0.0001
71761380|NCT00684060|143024234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|8.6|<|0.05|TWO_SIDED|95.0|-7.05|0.95||Threshold 0.05|t-test, 2 sided|No adjustment for multiple comparisons||Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||.95|-7.05|<0.05
71761381|NCT00684060|143024235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.05||95.0|0.08|1.17|||Fisher Exact|||comparison of the proportion of events in patients in the active group to those in patients in the control group||1.17|0.08|<0.05
71761382|NCT00684060|143024236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|17.2|<|0.05|TWO_SIDED|95.0|-9.3|6.8|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||6.8|-9.3|<0.05
71761383|NCT00684060|143024237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|21.8|<|0.05|TWO_SIDED|95.0|-9.5|10.9|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.||10.9|-9.5|<0.05
71761384|NCT00684060|143024238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|14.2|<|0.05|TWO_SIDED|95.0|-4.1|9.2|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||9.2|-4.1|<0.05
71761385|NCT00684060|143024239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|17.7|<|0.05||95.0|-9.9|6.9|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.||6.9|-9.9|<0.05
71761386|NCT00684060|143024240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|4.4|<|0.05|TWO_SIDED|95.0|-2.8|1.3||Unadjusted|t-test, 2 sided|||Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||1.3|-2.8|<0.05
71761387|NCT00684060|143024241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.05||95.0|-6.0|0.8|||t-test, 2 sided|||Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results||0.8|-6.0|<0.05
71761388|NCT02641561|143024261|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
71761389|NCT00702715|143024262|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence|Median Difference (Final Values)|78.0|||||TWO_SIDED|95.0|36.0|143.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||143.0|36.0|
71761390|NCT00702715|143024263|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|68.0|||||TWO_SIDED|95.0|36.0|120.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||120.0|36.0|
71761391|NCT00702715|143024264|NON_INFERIORITY_OR_EQUIVALENCE|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|60.0|||||TWO_SIDED|95.0|31.0|103.0|||Hodges-Lehmann and Moses||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)|||103.0|31.0|
71761392|NCT03751657|143024265|OTHER||Treatment difference|-0.18||||0.0818|TWO_SIDED|95.0|-0.38|0.02|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear mixed model for repeated measures (MMRM) with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate. Furthermore, the model includes the interaction between visit and all explanatory variables.||0.02|-0.38|0.0818
71761393|NCT03751657|143024279|OTHER||Treatment difference|-1.97||||0.0818|TWO_SIDED|95.0|-4.19|0.25|||Mixed Models Analysis|||The response and change from baseline in response after 26 weeks are analysed using a linear MMRM with an unstructured covariance matrix and treatment, region, use of DPP-4 inhibitor and visit as fixed factors, and baseline response as covariate.Furthermore, the model includes the interaction between visit and all explanatory variables.||0.25|-4.19|0.0818
71761394|NCT03894813|143024281|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71822345|NCT01115998|143146955|SUPERIORITY_OR_OTHER|||||||0.02||||||The a priori alpha level was \< 0.10 and was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.02
71700227|NCT03675308|142916255|SUPERIORITY||Least Squares (LS) Mean Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-0.26|-0.14||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.14|-0.26|<0.001
71700228|NCT03675308|142916256|SUPERIORITY||Response Rate Difference|42.5|||<|0.001|TWO_SIDED|95.0|35.6|49.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||49.3|35.6|<0.001
71700229|NCT03675308|142916257|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|16.8|29.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||29.4|16.8|<0.001
71700230|NCT03675308|142916258|SUPERIORITY||Response Rate Difference|14.8|||<|0.001|TWO_SIDED|95.0|10.2|19.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||19.4|10.2|<0.001
71700231|NCT03675308|142916259|SUPERIORITY||LS Mean Difference|-4.19|||<|0.001|TWO_SIDED|95.0|-5.7|-2.68||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-2.68|-5.70|<0.001
71822346|NCT01115998|143146955|SUPERIORITY_OR_OTHER|||||||0.52||||||The a priori alpha level was \<0.10 and was not adjusted for multiple comparisons|Wilcoxon Signed-Rank Test|||"Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.52
71822347|NCT01115998|143146955|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
71822348|NCT01115998|143146955|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.03
71822349|NCT01115998|143146955|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Signed-Rank Test|The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.||"Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||.006
71700232|NCT03675308|142916260|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.3|-0.6|<0.001
71700233|NCT03675308|142916261|SUPERIORITY||Response Rate Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.6|20.2||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use and extent of psoriasis at Baseline and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||20.2|7.6|<0.001
71700234|NCT03675308|142916262|SUPERIORITY||Response Rate Difference|16.9|||<|0.001|TWO_SIDED|95.0|7.5|26.4||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, extent of psoriasis at Baseline, and study.|Response Rate Difference = Risankizumab - Placebo|The pre-specified analysis for the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and KEEPsAKE 2 (M15-998; NCT03671148).||26.4|7.5|<0.001
71700235|NCT03675308|142916263|SUPERIORITY||LS Mean Difference|-0.09||||0.496|TWO_SIDED|95.0|-0.36|0.17||All primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment via a fixed sequence testing procedure to control the family-wise type I error rate at α=0.05 (two- sided).|ANCOVA|ANCOVA model including treatment and the stratification factors and baseline value as covariates.|Difference = Risankizumab - Placebo|||0.17|-0.36|0.496
71700236|NCT03675308|142916264|OTHER||LS Mean Difference|3.32|||<|0.001|TWO_SIDED|95.0|2.42|4.22||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||4.22|2.42|<0.001
71700237|NCT03675308|142916265|OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.5|3.7||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at the change from Baseline in PsA-mTSS comparison.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.7|1.5|<0.001
71700238|NCT03675308|142916266|SUPERIORITY||Response Rate Difference|22.2|||<|0.001|TWO_SIDED|95.0|17.3|27.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||27.2|17.3|<0.001
71700239|NCT03675308|142916267|SUPERIORITY||Response Rate Difference|10.5|||<|0.001|TWO_SIDED|95.0|6.9|14.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current csDMARD use, presence of dactylitis, enthesitis and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||14.2|6.9|<0.001
71700240|NCT03405870|142916287|OTHER|Determined maximum tolerated dose|Value of Maximum Tolerated Dose (g/kg)|1.6|||||TWO_SIDED|||||||||Using sequential dose escalation, participants received 2 doses of 1.0 to 1.6 g/kg of lipid emulsion (Smoflipid 20% lipid emulsion) within 48 hours of enrollment to test the maximum tolerated dose of study drug. The maximum tolerated dose was defined by patients exhibiting specific dose-related toxicities from administration of escalating doses of the study drug. Of 9 patients, adverse events were only considered dose-limiting toxicities if they met the predefined study protocol criteria.||||
71700241|NCT05172609|142916289|EQUIVALENCE|Margin difference of 1 standard deviation (SD) or higher was considered evidence of non-equivalence comparison||||||0.47|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for AIM||||.47
71700242|NCT05172609|142916290|EQUIVALENCE|Margin difference of 1 SD or higher was considered evidence of non-equivalence comparison||||||0.88|||||||t-test, 2 sided|||T-tests between EBIS and IAU conditions at 12-week follow up for FIM||||.88
71761395|NCT03894813|143024282|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71883223|NCT00623480|143286030|SUPERIORITY_OR_OTHER||Ratio (On-Demand vs. Prophylaxis)|14.7|||<|0.0001|TWO_SIDED|95.0|8.1|26.5|||Negative Binomial Regression Model|Adjusted for time of follow-up||||26.5|8.1|<0.0001
71700243|NCT05172609|142916291|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 3: two weeks after completing the training||||.46
71700244|NCT05172609|142916291|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS screening rating at Time 4: 12 weeks after completing the training||||.40
71700245|NCT05172609|142916291|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 3: two weeks after completing the training||||.56
71700246|NCT05172609|142916291|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing SUDS planning rating at Time 4: 12 weeks after completing the training||||.68
71700247|NCT05172609|142916291|SUPERIORITY|||||||0.87|||||||ANCOVA|||Repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS screening at timepoints 1, 3, and 4||||.87
71700248|NCT05172609|142916291|SUPERIORITY|||||||0.43|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SUDS planning at timepoints 1, 3, and 4||||.43
71700249|NCT05172609|142916292|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 3: two weeks after completing the training||||.59
71700250|NCT05172609|142916292|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening self-efficacy rating at Time 4: 12 weeks after completing the training||||.59
71700251|NCT05172609|142916292|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 3: two weeks after completing the training||||.25
71700252|NCT05172609|142916292|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing intervening self-efficacy rating at Time 4: 12 weeks after completing the training||||.35
71700253|NCT05172609|142916292|SUPERIORITY|||||||0.88|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy screening at timepoints 1, 3, and 4||||.88
71700254|NCT05172609|142916292|SUPERIORITY|||||||0.71|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: Self-efficacy intervening at timepoints 1, 3, and 4||||.71
71700255|NCT05172609|142916293|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 3: two weeks after completing the training||||.88
71700256|NCT05172609|142916293|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing screening use at Time 4: 12 weeks after completing the training||||.55
71700257|NCT05172609|142916293|SUPERIORITY|||||||0.36|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: CSR screening at timepoints 1, 3, and 4||||.36
71700258|NCT05172609|142916294|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 3: two weeks after completing the training||||.24
71700259|NCT05172609|142916294|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Test of superiority between EBIS and IAU groups comparing total SPIRS score at Time 4: 12 weeks after completing the training||||.88
71700260|NCT05172609|142916294|SUPERIORITY|||||||0.1|||||||ANCOVA|||repeated measures analysis of covariance (ANCOVA), controlling for organization: SPIRS at timepoints 3 and 4||||.10
71700261|NCT00614393|142916341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.06|TWO_SIDED|95.0|0.99|2.0|||Regression, Cox|||||2.00|0.99|0.06
71883224|NCT00623480|143286031|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.17||||0.6614|TWO_SIDED|95.0|-0.92|0.59|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||0.59|-0.92|0.6614
71700262|NCT00614393|142916341|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.18|TWO_SIDED|95.0|0.89|1.79|||Regression, Cox|||||1.79|0.89|0.18
71700263|NCT00614393|142916342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.07|TWO_SIDED|95.0|0.98|1.83|||Regression, Cox|||||1.83|0.98|0.07
71700264|NCT00614393|142916342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.44|TWO_SIDED|95.0|0.83|1.55|||Regression, Cox|||||1.55|0.83|0.44
71700265|NCT02328105|142916348|SUPERIORITY|Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.|Response Rate|0.364||||0.161|TWO_SIDED|95.0|0.109|0.692||This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.692|0.109|0.161
71700266|NCT02328105|142916349|OTHER|Estimation only.|Disease Control Rate|0.818|||||TWO_SIDED|95.0|0.482|0.977|||||Confidence interval estimated using the Clopper Pearson method.|||0.977|0.482|
71700267|NCT02328105|142916350|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|2.2|13.0|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||13.0|2.2|
71761396|NCT03894813|143024283|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71883225|NCT00623480|143286032|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|-0.94||||0.0072|TWO_SIDED|95.0|-1.61|-0.26|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||-0.26|-1.61|0.0072
71883226|NCT00623480|143286033|SUPERIORITY_OR_OTHER||estimated diff (prohylaxis vs. OD)|13.15|||||TWO_SIDED|95.0|5.23|21.08||no p-values computed|Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency||||21.08|5.23|
71883227|NCT01877187|143286035|OTHER|||||||0.06||||||Statistical significance defined as p \<= .05. Result is for Day 30 timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.06
71700268|NCT02328105|142916351|OTHER|Estimation only.|Median|30.0|||||TWO_SIDED|95.0|2.2||Upper limit of the confidence interval is not reached due to censoring rate.||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||2.2|
71700269|NCT02328105|142916352|OTHER|Estimation only.|Median|10.8|||||TWO_SIDED|95.0|4.9|11.9|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||11.9|4.9|
71700270|NCT02328105|142916353|OTHER|Estimation only.|Median|7.3|||||TWO_SIDED|95.0|3.0|13.0|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median disease control duration.|||13.0|3.0|
71700271|NCT01588509|142916354|SUPERIORITY||Percent Change from Baseline|2.13||||0.002|TWO_SIDED|90.0|1.05|3.2|||ANOVA|||||3.20|1.05|0.002
71700272|NCT01588509|142916354|SUPERIORITY||Percent Change from Baseline|2.08||||0.002|TWO_SIDED|90.0|1.02|3.14|||ANOVA|||||3.14|1.02|0.002
71700273|NCT01588509|142916355|SUPERIORITY||Percent Change from Baseline|2.06|||<|0.001|TWO_SIDED|90.0|1.07|3.05|||ANOVA|||||3.05|1.07|<0.001
71700274|NCT01588509|142916355|SUPERIORITY||Percent Change from Baseline|1.92||||0.002|TWO_SIDED|90.0|0.95|2.89|||ANOVA|||||2.89|0.95|0.002
71700275|NCT01588509|142916356|SUPERIORITY||Percent Change from Baseline|1.38|||<|0.001|TWO_SIDED|90.0|0.81|1.95|||ANOVA|||||1.95|0.81|<0.001
71700276|NCT01588509|142916356|SUPERIORITY||Percent Change from Baseline|1.4|||<|0.001|TWO_SIDED|90.0|0.84|1.96|||ANOVA|||||1.96|0.84|<0.001
71700277|NCT00855582|142916364|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.58|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700278|NCT00855582|142916365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.66|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700279|NCT00855582|142916366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.181||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.181
71700280|NCT00855582|142916367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.67|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700281|NCT00855582|142916368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761397|NCT03894813|143024284|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71822350|NCT01115998|143146955|SUPERIORITY_OR_OTHER|||||||0.45||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.45
71883228|NCT01877187|143286035|OTHER|||||||0.09||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||.09
71761398|NCT03894813|143024285|NON_INFERIORITY|The relevant parameters were determined as follows: test level α=0.05, test power 1-β=0.80, Pt=0.90, Pc=0.75, Nt:Nc=1:1, boundary value Δ= -0.0.068 (excellent), and Fisher's exact test. As a result, the sample size of each group was calculated as 50 patients, 100 patients in total. Considering a loss to follow-up rate of 20%, a sample size of 120 patients was finally determined, with 60 patients in each group.|||||<|0.01|||||||Chi-squared|||||||<0.01
71761399|NCT02656693|143024360|SUPERIORITY|||||||0.00017|||||||Mixed Models Analysis|||||||0.00017
71761400|NCT02656693|143024362|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71761401|NCT02656693|143024364|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71761402|NCT02656693|143024365|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71761403|NCT02656693|143024367|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71761404|NCT02656693|143024368|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71761405|NCT02656693|143024369|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71761406|NCT02656693|143024370|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
71761407|NCT02656693|143024371|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
71761408|NCT02656693|143024372|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71761409|NCT02656693|143024373|SUPERIORITY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
71822351|NCT01115998|143146956|SUPERIORITY_OR_OTHER|||||||0.92||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.92
71822352|NCT01115998|143146956|SUPERIORITY_OR_OTHER|||||||0.38||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.38
71822353|NCT01115998|143146956|SUPERIORITY_OR_OTHER|||||||0.42||90.0||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.42
71761410|NCT02656693|143024374|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
71761411|NCT02656693|143024375|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
71761412|NCT02656693|143024376|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
71761413|NCT02656693|143024377|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
71761414|NCT02656693|143024378|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
71761415|NCT02656693|143024379|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
71761416|NCT02656693|143024380|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
71761417|NCT02656693|143024381|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71761418|NCT02656693|143024382|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71761419|NCT02656693|143024383|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||||||0.42
71761420|NCT02656693|143024384|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
71761421|NCT02656693|143024385|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71761422|NCT02082119|143024400|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71761423|NCT02642315|143024426|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
71761424|NCT02642315|143024427|OTHER||Median Difference (Net)|36.0||||0.0131|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0131
71761425|NCT00662675|143024428|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-fat as a covariate.||The power calculation was based on the assumption that the true mean difference between the active and the placebo group was 31.2% with a common standard deviation of 22.6% using a 2-sided, 2-sample, t-test with a 5% significance level.||||<0.001
71761426|NCT00662675|143024429|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-protein(nitrogen) as a covariate.|ANCOVA|||||||<0.001
71761427|NCT02904954|143024470|SUPERIORITY||Risk Difference (RD)|46.6||||0.0001|TWO_SIDED|95.0|26.7|66.6||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the MPR proportion between the two treatment arms. Null hypothesis is that there is no difference in the MPR proportion between the two arms.||66.6|26.7|0.0001
71761428|NCT02904954|143024471|SUPERIORITY|||||||0.89|||||||Log Rank|||Kaplan-Meier survival analysis comparing the two arms.||||0.89
71761429|NCT02904954|143024472|SUPERIORITY||Risk Difference (RD)|43.4||||0.0001|TWO_SIDED|95.0|24.4|62.3||Testing at alpha = 0.05.|Fisher Exact|||Fisher's exact test performed to compare the objective clinical response proportion between the two treatment arms. Null hypothesis is that there is no difference in the objective clinical response proportion between the two arms. Objective clinical response proportion is defined as the proportion of patients in each arm who have complete response or partial response.||62.3|24.4|0.0001
71761430|NCT04661579|143024484|OTHER||Vaccine Efficacy|35.9||||0.009|TWO_SIDED|95.0|10.3|54.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 1 and 4. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||54.2|10.3|0.009
71761431|NCT04661579|143024485|OTHER||Vaccine Efficacy|-24.0||||0.369|TWO_SIDED|95.0|-97.0|22.2|||Wald test||Vaccine efficacy (VE) is defined as the percent reduction in the hazard, i.e. one minus the hazard ratio (HR, RTS,S/AS01E Vaccine vs. Rabies vaccine).|Vaccine efficacy against the first PCR-positive P. falciparum infection among adults who were P. falciparum positive at baseline was assessed using Cox proportional hazards regression model with a covariate for group assignment to compare Groups 2 and 5. HIV status, Age (tertiles), and sleep under a bednet were included as covariates.||22.2|-97|0.369
71761432|NCT00337675|143024500|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|5.3|STANDARD_ERROR_OF_MEAN|7.3||0.51||95.0|-11.4|19.6||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||19.6|-11.4|0.510
71761433|NCT00337675|143024500|SUPERIORITY_OR_OTHER_LEGACY||Rate reduction|-1.2|STANDARD_ERROR_OF_MEAN|7.8||0.884||95.0|-19.2|14.0||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.||14.0|-19.2|0.884
71761434|NCT00337675|143024501|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.176||95.0|-0.46|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.46|0.176
71761435|NCT00337675|143024501|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.202||95.0|-0.44|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.09|-0.44|0.202
71822354|NCT01115998|143146956|SUPERIORITY_OR_OTHER|||||||0.57||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.57
71883229|NCT01877187|143286035|OTHER|||||||0.034||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.034
71700282|NCT00855582|142916369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761436|NCT00337675|143024502|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.045||95.0|-0.24|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.24|0.045
71883230|NCT01877187|143286037|OTHER|||||||0.19||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.19
71700283|NCT00855582|142916370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.85|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71883231|NCT01877187|143286037|OTHER|||||||0.011||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.011
71700284|NCT00855582|142916371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.156||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.156
71700285|NCT00855582|142916372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.226||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.226
71700286|NCT00855582|142916372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700287|NCT00855582|142916373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.121
71700288|NCT00855582|142916373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.57||0.169||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.169
71700289|NCT00855582|142916373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.52|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700290|NCT00855582|142916373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.56|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700291|NCT00855582|142916374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700292|NCT00855582|142916374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700293|NCT00855582|142916374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.59|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700294|NCT00855582|142916374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700295|NCT00855582|142916375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700296|NCT00855582|142916375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71738809|NCT01363908|142990423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0781
71761437|NCT00337675|143024502|SUPERIORITY_OR_OTHER_LEGACY||Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.061||95.0|-0.23|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or \[intermittent and daily regimens\]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.||0.00|-0.23|0.061
71761438|NCT01317277|143024512|SUPERIORITY|||||||0.68||||||In between-group analyses, overall MEMS adherence was defined as % of doses taken.|Wilcoxon (Mann-Whitney)|Non-parametric methods.||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.68
71761439|NCT01317277|143024513|SUPERIORITY|||||||0.95||||||MEMS adherence based on dose timing was examined for between-group differences.|Wilcoxon (Mann-Whitney)|Non-parametric methods||Randomization strategy for target 75 participants of 2:1 \[iTAB(n=50):CTRL(n=25)\], resulting in 80% power to detect effect size of .71 for difference of adherence rates between groups (Wilcoxon-Mann-Whitney critical t=1.99, df=69.6). Final # analyzed: iTAB (n=43) \& CTRL (n=23).||||0.95
71761440|NCT01317277|143024514|SUPERIORITY|||||||0.05||||||Z = -1.97|Wilcoxon (Mann-Whitney)|Non-parametric methods; P-Value is calculated.||Text-reported METH use days||||0.05
71761441|NCT00912795|143024522|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|0.62|
71761442|NCT00912795|143024523|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.5|3.2||||||||3.2|0.50|
71761443|NCT00912795|143024524|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5|||||TWO_SIDED|95.0|0.81|7.5||||||||7.5|0.81|
71761444|NCT00912795|143024525|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.62|6.3||||||||6.3|.62|
71822355|NCT01115998|143146956|SUPERIORITY_OR_OTHER|||||||0.69||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Personal-social total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.69
71883232|NCT01877187|143286037|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
71822356|NCT01115998|143146956|SUPERIORITY_OR_OTHER|||||||0.28||||||The a priori alpha level was \<0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"BID total score~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||0.28
71822357|NCT01115998|143146957|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
71883233|NCT01877187|143286039|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
71890323|NCT03952559|143302138|SUPERIORITY||LS Mean difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.6574|TWO_SIDED|95.0|-0.27|0.42|||Mixed Models Analysis|||||0.42|-0.27|0.6574
71761445|NCT01243580|143024535|EQUIVALENCE|Comparing Ortho-Cyclen to Ag200-15|||||<|0.0001|||||||ANOVA|||||||<0.0001
71761446|NCT01243580|143024536|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen|||||<|0.0001|||||||ANOVA|||||||<0.0001
71761447|NCT01243580|143024537|EQUIVALENCE|Comparison of AG200-15 and Ortho-Cyclen||||||0.0001|||||||ANOVA|||||||0.0001
71761448|NCT01243580|143024538|EQUIVALENCE|Comparison of Ortho-Cylen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
71761449|NCT01243580|143024539|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0009|||||||ANOVA|||||||0.0009
71761450|NCT01243580|143024540|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0167|||||||ANOVA|||||||0.0167
71761451|NCT01243580|143024541|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0007|||||||ANOVA|||||||0.0007
71761452|NCT01243580|143024542|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0175|||||||ANOVA|||||||0.0175
71761453|NCT01243580|143024543|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0001|||||||ANOVA|||||||0.0001
71761454|NCT01243580|143024544|EQUIVALENCE|Comparison of Ortho-Cyclen and AG200-15||||||0.0532|||||||ANOVA|||||||0.0532
71761455|NCT03904693|143024553|SUPERIORITY||Geometric Mean Ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||ANCOVA|||||0.82|0.61|<0.0001
71761456|NCT03904693|143024553|SUPERIORITY||Geometric Mean Ratio|0.72|||<|0.0001|TWO_SIDED|95.0|0.64|0.8|||ANCOVA|||||0.80|0.64|<0.0001
71761457|NCT05307692|143024596|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.47||0.308|TWO_SIDED|80.0|-3.41|0.39|||Mixed model repeated measures|||||0.39|-3.41|0.308
71761458|NCT05307692|143024597|SUPERIORITY||Difference of Least Square (LS) Means|-1.5|STANDARD_ERROR_OF_MEAN|1.42||0.282|TWO_SIDED|80.0|-3.33|0.29|||Mixed model repeated measures|||||0.29|-3.33|0.282
71774881|NCT00537238|143050061|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.22|STANDARD_ERROR_OF_MEAN|0.35||0.5263|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.91|-0.47|0.5263
71774882|NCT00537238|143050061|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.25|STANDARD_ERROR_OF_MEAN|0.3||0.4008|TWO_SIDED|95.0|-0.34|0.85|||ANCOVA|||Week 16, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.85|-0.34|0.4008
71822358|NCT01115998|143146957|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."||||>0.10
71774883|NCT00537238|143050061|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9749|TWO_SIDED|95.0|-0.61|0.59|||ANCOVA|||Week 16, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.59|-0.61|0.9749
71822359|NCT01268059|143146959|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.205||||0.027|TWO_SIDED|95.0|1.1|4.5|||Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by histology, disease stage, and ECOG performance status.|Hazard ratio and its 95 percent (%) confidence interval ( CIs) were calculated using the Cox proportional hazard model stratified by histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|||4.5|1.1|0.027
71822360|NCT01268059|143146961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and Eastern Cooperative Oncology Group (ECOG) performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.487
71822361|NCT01268059|143146961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||||||The 2-sided p-value was calculated by adjusting for the stratification factors histology, disease stage, and ECOG performance status.|Cochran-Mantel-Haenszel|||Treatment effect Carboplatin/Paclitaxel + MEDI-575 versus Carboplatin/Paclitaxel.||||0.386
71700297|NCT00855582|142916375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700298|NCT00855582|142916375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700299|NCT00855582|142916376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.215||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.215
71700300|NCT00855582|142916376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.325||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.325
71700301|NCT00855582|142916376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700302|NCT00855582|142916376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.011||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.011
71700303|NCT00855582|142916377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.23||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.230
71700304|NCT00855582|142916377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.37|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700305|NCT00855582|142916378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.191||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.191
71700306|NCT00855582|142916378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700307|NCT00855582|142916379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.763||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.763
71700308|NCT00855582|142916379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.075||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.075
71883234|NCT01877187|143286039|OTHER|||||||0.017||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.017
71761459|NCT05407064|143024601|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 4 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 4 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 4 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
71761460|NCT05407064|143024602|SUPERIORITY|Mean change from baseline and mean difference between MM120 dose groups and placebo were estimated using model averaging method (of 3 models). The minimally efficacious dose was defined as a placebo-adjusted improvement of 2.5 points on the HAM-A, with a statistical significance set at an alpha level of 0.05.||||||||||||||||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in total HAM-A score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed, and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.|A test statistic was derived from the data using an ANCOVA model with change from Baseline to Week 8 for the HAM-A Total Score as a response variable, treatment arm and Baseline value of HAM-A Total Score as covariates. The ANCOVA model was repeated for each imputed dataset, which resulted in a set of LS mean estimates for all dose groups and the related covariance matrices. Rubin's rule was used to combine the multiple sets of LS mean estimates and the related covariance matrices to a single set of LS mean estimates of change from Baseline to Week 8 for HAM-A Total Score for all dose groups and the related covariance matrix. The SAS procedure PROC MIANALYZE was used to combine the results from imputed datasets.|||
71761461|NCT05407064|143024603|SUPERIORITY|||||||0.1157|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1157
71761462|NCT05407064|143024603|SUPERIORITY|||||||0.663|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.6630
71761463|NCT05407064|143024603|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0004
71761464|NCT05407064|143024603|SUPERIORITY|||||||0.01|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0100
71822362|NCT01268059|143146964|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.017|||||TWO_SIDED|95.0|1.2|7.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||7.4|1.2|
71822363|NCT01268059|143146964|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.134|||||TWO_SIDED|95.0|0.3|4.3|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||4.3|0.3|
71700309|NCT00855582|142916380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.384||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.384
71761465|NCT05407064|143024604|SUPERIORITY|||||||0.2309|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2309
71761466|NCT05407064|143024604|SUPERIORITY|||||||0.7218|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.7218
71761467|NCT05407064|143024604|SUPERIORITY|||||||0.0637|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0637
71761468|NCT05407064|143024604|SUPERIORITY|||||||0.0216|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0216
71761469|NCT05407064|143024605|SUPERIORITY|||||||0.1006|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.1006
71761470|NCT05407064|143024605|SUPERIORITY|||||||0.2225|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.2225
71761471|NCT05407064|143024605|SUPERIORITY|||||||0.0025|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0025
71761472|NCT05407064|143024605|SUPERIORITY|||||||0.0042|||||||ANCOVA|||Change from Baseline: ANCOVA determination of Least Squares (LS) Mean and difference in LS Mean from placebo||||0.0042
71761473|NCT05407064|143024606|SUPERIORITY|||||||0.6258|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6258
71761474|NCT05407064|143024606|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.95
71761475|NCT05407064|143024606|SUPERIORITY|||||||0.0174|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0174
71822364|NCT01268059|143146965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.315|||||TWO_SIDED|95.0|0.7|2.4|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||2.4|0.7|
71822365|NCT01268059|143146965|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.083|||||TWO_SIDED|95.0|0.4|10.8|||||The 95% confidence interval calculated using the Cox proportional hazard model stratified by histology, disease stage, and ECOG performance status.|||10.8|0.4|
71761476|NCT05407064|143024606|SUPERIORITY|||||||0.0206|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0206
71761477|NCT05407064|143024607|SUPERIORITY|||||||0.5538|||||||t-test, 2 sided|||Assessment of change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.5538
71761478|NCT05407064|143024607|SUPERIORITY|||||||0.665|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.6650
71761479|NCT05407064|143024607|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0190
71761480|NCT05407064|143024607|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0034
71761481|NCT05407064|143024608|SUPERIORITY|||||||0.7236|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.7236
71761482|NCT05407064|143024608|SUPERIORITY|||||||0.9738|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.9738
71822366|NCT02819479|143146978|OTHER||eta^2|0.37||||0.012|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 8.29||CHANGE IN VOLUME OF RADIATION NECROSIS: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.012
71890324|NCT03952559|143302138|SUPERIORITY||LS Mean difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.172||0.9488|TWO_SIDED|95.0|-0.35|0.33|||Mixed Models Analysis|||||0.33|-0.35|0.9488
71700310|NCT00855582|142916380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.082||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||0.082
71761483|NCT05407064|143024608|SUPERIORITY|||||||0.0338|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0338
71761484|NCT05407064|143024608|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test)||||0.0282
71761485|NCT05407064|143024609|SUPERIORITY|||||||0.9302|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.9302
71761486|NCT05407064|143024609|SUPERIORITY|||||||0.6763|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.6763
71761487|NCT05407064|143024609|SUPERIORITY|||||||0.0816|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0816
71761488|NCT05407064|143024609|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0190
71761489|NCT05407064|143024610|SUPERIORITY|||||||0.5647|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.5647
71761490|NCT05407064|143024610|SUPERIORITY|||||||0.3497|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3497
71761491|NCT05407064|143024610|SUPERIORITY|||||||0.0229|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0229
71761492|NCT05407064|143024610|SUPERIORITY|||||||0.0073|||||||t-test, 2 sided|||Change from baseline in total MADRS scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0073
71761493|NCT05407064|143024611|SUPERIORITY|||||||0.0158|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0158
71761494|NCT05407064|143024611|SUPERIORITY|||||||0.0429|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0429
71761495|NCT05407064|143024611|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
71761496|NCT05407064|143024611|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
71761497|NCT05407064|143024612|SUPERIORITY|||||||0.0804|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0804
71761498|NCT05407064|143024612|SUPERIORITY|||||||0.0532|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0532
71761499|NCT05407064|143024612|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0001
71761500|NCT05407064|143024612|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
71761501|NCT05407064|143024613|SUPERIORITY|||||||0.2152|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.2152
71822367|NCT02819479|143146978|OTHER||eta^2|0.19||||0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(1,14) = 3.29||CHANGE IN VOLUME OF CEREBRAL EDEMA: To explore durability of radiographic responses, we invoked a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.09
71822368|NCT02819479|143146979|OTHER||eta^2|0.29||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 2.74||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) TOTAL SCORES were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance)||||0.02
71883235|NCT01877187|143286039|OTHER|||||||0.08||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.08
71761502|NCT05407064|143024613|SUPERIORITY|||||||0.3369|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3369
71761503|NCT05407064|143024613|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0010
71761504|NCT05407064|143024613|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Assessment of change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0046
71761505|NCT05407064|143024614|SUPERIORITY|||||||0.4489|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.4489
71761506|NCT05407064|143024614|SUPERIORITY|||||||0.7326|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.7326
71761507|NCT05407064|143024614|SUPERIORITY|||||||0.0492|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0492
71761508|NCT05407064|143024614|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0131
71761509|NCT05407064|143024615|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.3330
71761510|NCT05407064|143024615|SUPERIORITY|||||||0.1193|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.1193
71761511|NCT05407064|143024615|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0032
71890219|NCT03529409|143302022|SUPERIORITY||Mean Difference (Net)|-0.16||||0.87|TWO_SIDED|95.0|-1.85|1.58||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.58|-1.85|.87
71761512|NCT05407064|143024615|SUPERIORITY|||||||0.0127|||||||t-test, 2 sided|||Change from baseline in total CGI-S scores determined by the difference in means and difference between treatment and placebo (p-value determined from two-sample t-test).||||0.0127
71761513|NCT05407064|143024616|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0046
71761514|NCT05407064|143024616|SUPERIORITY|||||||0.0052|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0052
71761515|NCT05407064|143024616|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71761516|NCT05407064|143024616|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71761517|NCT05407064|143024617|SUPERIORITY|||||||0.0567|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0567
71761518|NCT05407064|143024617|SUPERIORITY|||||||0.0235|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0235
71761519|NCT05407064|143024617|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71761520|NCT05407064|143024617|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71761521|NCT05407064|143024618|SUPERIORITY|||||||0.2632|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2632
71761522|NCT05407064|143024618|SUPERIORITY|||||||0.2962|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.2962
71761523|NCT05407064|143024618|SUPERIORITY|||||||0.0013|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0013
71761524|NCT05407064|143024618|SUPERIORITY|||||||0.0547|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0547
71761525|NCT05407064|143024619|SUPERIORITY|||||||0.0937|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0937
71761526|NCT05407064|143024619|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.8230
71761527|NCT05407064|143024619|SUPERIORITY|||||||0.0032|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0032
71761528|NCT05407064|143024619|SUPERIORITY|||||||0.0129|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0129
71761529|NCT05407064|143024620|SUPERIORITY|||||||0.1889|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1889
71761530|NCT05407064|143024620|SUPERIORITY|||||||0.1589|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1589
71761531|NCT05407064|143024620|SUPERIORITY|||||||0.0008|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0008
71761532|NCT05407064|143024620|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Difference in mean CGI-I total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0194
71761533|NCT05407064|143024621|SUPERIORITY|||||||0.0057|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0057
71822369|NCT02819479|143146980|OTHER||eta^2|0.37||||0.019|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,34) = 3.17||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) DAYS OF HEADACHE were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.019
71822370|NCT02819479|143146981|OTHER||eta^2|0.3||||0.0006|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5,35) = 3.96||To explore durability of clinical response, Migraine Disability Assessment (MIDAS) MIDAS PAIN LEVEL data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.0006
71822371|NCT02819479|143146982|OTHER||eta^2|0.3||||0.02|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(5, 35) = 2.98||To explore durability of clinical response, Headache Impact Test (HIT-6™) scores were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.02
71822372|NCT02819479|143146983|OTHER||eta^2|0.19||||0.23|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|F(2,14) = 1.62||To explore durability of clinical response, Karnofsky Performance Status Scale (KPS) data were analyzed using a linear mixed model in which we addressed heterogeneity of time points by fitting the most appropriate model among compound symmetry, Huyhn-Felt structure, and an unstructured covariance matrix (multivariate analysis of variance).||||0.23
71700311|NCT00855582|142916381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71883236|NCT01877187|143286041|OTHER|||||||0.02||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.020
71761534|NCT05407064|143024621|SUPERIORITY|||||||0.0168|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0168
71761535|NCT05407064|143024621|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||0.0000
71761536|NCT05407064|143024621|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0000
71761537|NCT05407064|143024622|SUPERIORITY|||||||0.0958|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0958
71761538|NCT05407064|143024622|SUPERIORITY|||||||0.0544|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0544
71761539|NCT05407064|143024622|SUPERIORITY|||||||0.0029|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0029
71761540|NCT05407064|143024622|SUPERIORITY|||||||0.0006|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0006
71761541|NCT05407064|143024623|SUPERIORITY|||||||0.2038|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.2038
71761542|NCT05407064|143024623|SUPERIORITY|||||||0.1977|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.1977
71761543|NCT05407064|143024623|SUPERIORITY|||||||0.0357|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0357
71761544|NCT05407064|143024623|SUPERIORITY|||||||0.0302|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test)||||0.0302
71761545|NCT05407064|143024624|SUPERIORITY|||||||0.2165|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2165
71761546|NCT05407064|143024624|SUPERIORITY|||||||0.6868|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.6868
71761547|NCT05407064|143024624|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1350
71761548|NCT05407064|143024624|SUPERIORITY|||||||0.0273|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.0273
71761549|NCT05407064|143024625|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2450
71761550|NCT05407064|143024625|SUPERIORITY|||||||0.3461|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.3461
71761551|NCT05407064|143024625|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.1110
71761552|NCT05407064|143024625|SUPERIORITY|||||||0.2386|||||||t-test, 2 sided|||Change from baseline in total PGI-S scores and the difference in means between treatment and placebo (p-value determined from two-sample t-test).||||0.2386
71761553|NCT05407064|143024626|SUPERIORITY|||||||0.1475|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1475
71761554|NCT05407064|143024626|SUPERIORITY|||||||0.0308|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0308
71761555|NCT05407064|143024626|SUPERIORITY|||||||0|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0000
71761556|NCT05407064|143024626|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0004
71761557|NCT05407064|143024627|SUPERIORITY|||||||0.0873|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0873
71700312|NCT00855582|142916381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761558|NCT05407064|143024627|SUPERIORITY|||||||0.1702|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1702
71761559|NCT05407064|143024627|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0007
71761560|NCT05407064|143024627|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0001
71761561|NCT05407064|143024628|SUPERIORITY|||||||0.4193|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.4193
71761562|NCT05407064|143024628|SUPERIORITY|||||||0.1663|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1663
71761563|NCT05407064|143024628|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0002
71761564|NCT05407064|143024628|SUPERIORITY|||||||0.0306|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0306
71761565|NCT05407064|143024629|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0534
71761566|NCT05407064|143024629|SUPERIORITY|||||||0.6551|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.6551
71761567|NCT05407064|143024629|SUPERIORITY|||||||0.0079|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.0079
71761568|NCT05407064|143024629|SUPERIORITY|||||||0.1133|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test||||0.1133
71761569|NCT05407064|143024630|SUPERIORITY|||||||0.1248|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1248
71761570|NCT05407064|143024630|SUPERIORITY|||||||0.1788|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.1788
71761571|NCT05407064|143024630|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0030
71761572|NCT05407064|143024630|SUPERIORITY|||||||0.0534|||||||t-test, 2 sided|||Difference in mean PGI-C total scores (MM120-placebo); p-value determined from two-sample t-test.||||0.0534
71761573|NCT02003924|143024679|SUPERIORITY||Hazard Ratio (HR)|0.292|||<|0.0001|TWO_SIDED|95.0|0.241|0.352||P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.352|0.241|<0.0001
71761574|NCT02003924|143024680|SUPERIORITY||Hazard Ratio (HR)|0.066|||<|0.0001|TWO_SIDED|95.0|0.054|0.081||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.||0.081|0.054|<0.0001
71761575|NCT02003924|143024681|SUPERIORITY||Hazard Ratio (HR)|0.208|||<|0.0001|TWO_SIDED|95.0|0.168|0.258||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.||0.258|0.168|<0.0001
71761576|NCT02003924|143024682|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0011|TWO_SIDED|95.0|0.608|0.885||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.||0.885|0.608|0.0011
71822373|NCT02819479|143146984|OTHER||Pearson's r|-0.199||||0.374|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|Z = -0.889||Wilcoxon signed rank test (2-sided) was used to compare the total number of days on steroids in the 12 months prior versus the 12 months immediately following single dose IA Avastin (bevacizumab).||||0.374
71822374|NCT02819479|143146985|OTHER||partial eta^2|0.153||||0.66|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.451||DIGITS FORWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS FORWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.660
71700313|NCT00855582|142916382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761577|NCT02003924|143024683|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.6534|TWO_SIDED|95.0|0.801|1.149||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||1.149|0.801|0.6534
71761578|NCT02003924|143024684|SUPERIORITY||Hazard Ratio (HR)|0.378|||<|0.0001|TWO_SIDED|95.0|0.282|0.507||P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.|||0.507|0.282|<0.0001
71761579|NCT02003924|143024687|SUPERIORITY||Difference in Response Rate|73.96|||<|0.0001|TWO_SIDED|95.0|70.91|77.02||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 50%||77.02|70.91|<0.0001
71761580|NCT02003924|143024687|SUPERIORITY||Difference in Response Rate|55.52|||<|0.0001|TWO_SIDED|95.0|52.28|58.76||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS|Cochran-Mantel-Haenszel|||Decrease from Baseline \>= 90%||58.76|52.28|<0.0001
71761581|NCT02003924|143024687|SUPERIORITY||Difference in Response Rate|9.65|||<|0.0001|TWO_SIDED|95.0|7.75|11.54||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (\<6 months, \>= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease to Undetectable Level||11.54|7.75|<0.0001
71761582|NCT04301193|143024763|OTHER||Correlation - R value|0.93|||<|0.05|TWO_SIDED||||||Regression, Linear|||Using standard techniques for estimating sample size, a Delong's test indicated that a total of 61 samples would be sufcient to detect a 0.2 increase in the AUROC from the null hypothesis 0.5, assuming an alpha level of 5% and 90% power \[12\]. The manuscript was referenced against the STROBE checklist for cohort studies. Descriptive statistics were used to present.||||<0.05
71761583|NCT04301193|143024763|OTHER||Correlation - R value|0.77|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71700314|NCT00855582|142916382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761584|NCT03229941|143024835|SUPERIORITY||Odds Ratio (OR)|0.89||||0.515|TWO_SIDED|95.0|0.62|1.27|||Chi-squared||Liberal vs. restrictive arm comparison.|||1.27|0.62|0.515
71761585|NCT03229941|143024836|SUPERIORITY||Odds Ratio (OR)|1.09||||0.587|TWO_SIDED|99.0|0.73|1.61|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.61|0.73|0.587
71890220|NCT03529409|143302027|SUPERIORITY||Mean Difference (Net)|-0.47||||0.65|TWO_SIDED|95.0|-2.49|1.55||The overall omnibus test of the time by treatment interaction was p=.89. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||1.55|-2.49|.65
71761586|NCT03229941|143024837|SUPERIORITY||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|99.0|0.33|0.98|||Chi-squared||Liberal vs. Restrictive arm comparison|||0.98|0.33|0.007
71761587|NCT03229941|143024838|SUPERIORITY||Odds Ratio (OR)|0.93||||0.634|TWO_SIDED|99.0|0.63|1.38|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.38|0.63|0.634
71761588|NCT03229941|143024839|SUPERIORITY||Odds Ratio (OR)|0.75||||0.212|TWO_SIDED|99.0|0.41|1.37|||Chi-squared||Liberal vs. Restrictive arm comparison|||1.37|0.41|0.212
71822375|NCT02819479|143146985|OTHER||partial eta^2|0.602||||0.1|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 3.78||DIGITS BACKWARD: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DIGITS BACKWARD variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.100
71822376|NCT02819479|143146985|OTHER||partial eta^2|0.532||||0.149|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 2.847||NUMBERS \& LETTERS SPEED: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS SPEED variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.149
71822377|NCT02819479|143146985|OTHER||partial eta^2|0.721||||0.041|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 6.470||NUMBERS \& LETTERS ERRORS: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS ERRORS variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.041
71822378|NCT02819479|143146985|OTHER||partial eta^2|0.566||||0.124|TWO_SIDED||||||One way Repeat Meas ANOVA|F (2,5) = 3.256||NUMBERS \& LETTERS EFFICIENCY: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NUMBERS \& LETTERS EFFICIENCY variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.124
71822379|NCT02819479|143146985|OTHER||partial eta^2|0.042||||0.898|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.110||NAMING: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the NAMING variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.898
71822380|NCT02819479|143146985|OTHER||partial eta^2|0.107||||0.754|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.299||LIST LEARNING LIST IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.754
71761589|NCT03229941|143024840|SUPERIORITY|||||||0.786|||||||Wilcoxon (Mann-Whitney)|||||||0.786
71822381|NCT02819479|143146985|OTHER||partial eta^2|0.751||||0.031|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 7.556||LIST LEARNING LIST LONG DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the LIST LEARNING LIST LONG DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.031
71700315|NCT00855582|142916383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761590|NCT02840799|143024841|SUPERIORITY||Mean Difference (Final Values)|-0.1309108|STANDARD_ERROR_OF_MEAN|0.2619326||0.6191|TWO_SIDED|95.0|-0.6552259|0.3934043||A two-sided α=0.05 was determined by the power calculation.|t-test, 2 sided|t = -0.49979, df = 58. N=59 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.|Only participants that successfully crossed over were included in the t-test (N=59).|We considered an increase in peak VO2 of \~0.6 ml/kg/min to be the minimum clinically significant change. Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints with a two-sided α=0.05. PASS11157 was used to perform power calculations.||0.3934043|-0.6552259|0.6191
71761591|NCT02840799|143024841|SUPERIORITY||Slope|0.1||||0.711|TWO_SIDED|95.0|-0.043|0.62||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.62|-.043|0.711
71822382|NCT02819479|143146985|OTHER||partial eta^2|0.289||||0.426|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.018||SHAPE LEARNING IMMEDIATE RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING IMMEDIATE RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.426
71761592|NCT02840799|143024842|SUPERIORITY||Mean Difference (Final Values)|2.217657|STANDARD_ERROR_OF_MEAN|2.065196||0.2871|TWO_SIDED|95.0|-1.910612|6.3459261|||t-test, 2 sided|t = 1.0738, df = 62, p-value = 0.2871, N=63 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossovered.||A two-sided α=0.05 was determined by the power calculation.||6.3459261|-1.910612|0.2871
71761593|NCT02840799|143024842|SUPERIORITY||Slope|-2.12||||0.2935|TWO_SIDED|95.0|-6.12|1.88||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect. Randomization sequence was not included in the final model due to lack of evidence for a carry over effect. Phase 1 data for participants that did not crossover due to IDS were considered for the model (N=74).||1.88|-6.12|0.2935
71822383|NCT02819479|143146985|OTHER||partial eta^2|0.361||||0.326|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 1.412||SHAPE LEARNING DELAYED RECOGNITION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the SHAPE LEARNING DELAYED RECOGNITION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.326
71890325|NCT03952559|143302138|SUPERIORITY||LS Mean difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4546|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||||0.21|-0.47|0.4546
71822384|NCT02819479|143146985|OTHER||partial eta^2|0.09||||0.79|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.247||STORY LEARNING PHRASE UNIT IMMEDIATE RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT IMMEDIATE RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.790
71822385|NCT02819479|143146985|OTHER||partial eta^2|0.239||||0.505|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.786||STORY LEARNING PHRASE UNIT DELAYED RECALL: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the STORY LEARNING PHRASE UNIT DELAYED RECALL variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.505
71822386|NCT02819479|143146985|OTHER||partial eta^2|0.636||||0.08|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 4.362||DESIGN CONSTRUCTION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the DESIGN CONSTRUCTION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.080
71822387|NCT02819479|143146985|OTHER||partial eta^2|0.693||||0.052|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 5.654||MAZES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the MAZES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.052
71822388|NCT02819479|143146985|OTHER||partial eta^2|0.013||||0.968|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.033||CATEGORIES: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the CATEGORIES variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.968
71700316|NCT00855582|142916383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761594|NCT02840799|143024843|SUPERIORITY||Mean Difference (Final Values)|2.1859922|STANDARD_ERROR_OF_MEAN|1.578944||0.171|TWO_SIDED|95.0|-0.9674467|5.3392901||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3844, df=65, p=0.171. N=66 due to analyzing participants with complete data for Phase 1 and Phase 2 that crossover correctly.||||5.3392901|-0.9674467|0.171
71761595|NCT02840799|143024843|SUPERIORITY||Slope|-2.51||||0.113|TWO_SIDED|95.0|-5.62|0.61||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.61|-5.62|0.113
71761596|NCT02840799|143024844|SUPERIORITY||Mean Difference (Final Values)|2.776572|STANDARD_ERROR_OF_MEAN|3.99464||0.4905|TWO_SIDED|95.0|-5.264221|10.817366||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t = 0.69507, df=46, p=.4905. N=47 due to only analyzed participants that correctly crossovered.||||10.817366|-5.264221|0.4905
71761597|NCT02840799|143024844|SUPERIORITY||Slope|1.088||||0.796|TWO_SIDED|95.0|-7.3|9.48||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||9.48|-7.30|0.796
71761598|NCT02840799|143024845|SUPERIORITY||Mean Difference (Final Values)|-38.11189|STANDARD_ERROR_OF_MEAN|43.84245||0.4017|TWO_SIDED|95.0|-133.63637|57.41259|||t-test, 2 sided|t=-0.86929,, df=12, p=0.4017||||57.41259|-133.63637|0.4017
71761599|NCT02840799|143024845|SUPERIORITY||Slope|61.77||||0.183|TWO_SIDED|95.0|-34.15|157.69||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||157.69|-34.15|0.183
71761600|NCT02840799|143024846|SUPERIORITY||Mean Difference (Final Values)|0.202782|STANDARD_ERROR_OF_MEAN|0.202782||0.5636|TWO_SIDED|95.0|-0.4959279|0.9014918||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=0.58074, df=59, p=0.5636||||0.9014918|-0.4959279|0.5636
71700317|NCT00855582|142916384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71822389|NCT02819479|143146985|OTHER||partial eta^2|0.261||||0.469|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|One way Repeat Meas ANOVA|F(2,5) = 0.884||WORD GENERATION: To explore post-operative change in Neurocognitive performance after intra-arterial bevacizumab, repeated measures ANOVA was performed for the WORD GENERATION variable across 3 time points (BL, 3 months, 12 months) where IQ was placed in the model as covariate.||||0.469
71822390|NCT05310084|143146994|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate-administration group) was greater than 0.67.|GMR|0.83|||||TWO_SIDED|95.0|0.77|0.89|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of concentrations (coadmin group-separate admin group), corresponding CIs based on analysis of log transformed assay results using a linear regression model.|||0.89|0.77|
71700318|NCT00855582|142916384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71761601|NCT02840799|143024846|SUPERIORITY||Slope|-0.3118||||0.361|TWO_SIDED|95.0|-0.99|0.37||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||0.37|-0.99|0.361
71761602|NCT02840799|143024847|SUPERIORITY||Mean Difference (Final Values)|-0.1532142|STANDARD_ERROR_OF_MEAN|-0.1532142||0.7707|TWO_SIDED|95.0|-1.1998786|0.8934502||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t= -0.29271, df=61, p=0.7707||||0.8934502|-1.1998786|0.7707
71761603|NCT02840799|143024847|SUPERIORITY||Slope|0.18872||||0.724|TWO_SIDED|95.0|-0.88|1.25||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||The mixed model analysis provided an assessment of the treatment effect on each continuous outcome of interest while controlling for effects of other covariates such as period, sequence, and a random subject effect.||1.25|-0.88|0.724
71700319|NCT00855582|142916385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700320|NCT00855582|142916385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700321|NCT00855582|142916386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.9|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700322|NCT00855582|142916386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.7|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700323|NCT00855582|142916387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700324|NCT00855582|142916387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.||||||<0.001
71700325|NCT00855582|142916388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
71700326|NCT00855582|142916388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
71700327|NCT00855582|142916389|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||0.006
71700328|NCT00855582|142916389|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.||||||<0.001
71700329|NCT00855582|142916390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
71700330|NCT00855582|142916390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
71738810|NCT01363908|142990423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.5000
71761604|NCT02840799|143024848|SUPERIORITY||Mean Difference (Final Values)|0.3262821|STANDARD_ERROR_OF_MEAN|0.2333465||0.1680825|TWO_SIDED|95.0|-0.1421806|0.7947447||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|t=1.3983, df=51, p=0.1681||||0.7947447|-0.1421806|0.1680825
71761605|NCT02840799|143024848|SUPERIORITY||Slope|-0.4082||||0.093|TWO_SIDED|95.0|-0.88|0.07||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.07|-0.88|0.0930
71761606|NCT02840799|143024849|SUPERIORITY||Mean Difference (Final Values)|-2.116437|STANDARD_ERROR_OF_MEAN|1.176768||0.07984|TWO_SIDED|95.0|-4.4966754|0.2638017||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided||t = -1.7985, df=39, p=0.07984|||0.2638017|-4.4966754|0.07984
71761607|NCT02840799|143024849|SUPERIORITY||Slope|1.68||||0.135|TWO_SIDED|95.0|-0.54|3.9||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||3.90|-0.54|0.135
71761608|NCT02840799|143024850|SUPERIORITY||Mean Difference (Final Values)|-0.0192733|STANDARD_ERROR_OF_MEAN|0.01295984||0.145|TWO_SIDED|95.0|-0.0454871|0.0069404||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||0.00694040|-0.0454871|0.1450
71761609|NCT02840799|143024850|SUPERIORITY||Slope|0.01324||||0.3047|TWO_SIDED|95.0|-0.01|0.04||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||0.04|-0.01|0.3047
71761610|NCT02840799|143024851|SUPERIORITY||Mean Difference (Final Values)|-3.506681|STANDARD_ERROR_OF_MEAN|4.494971||0.44|TWO_SIDED|95.0|-12.598617|5.585256||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|t-test, 2 sided|||||5.585256|-12.598617|0.44
71761611|NCT02840799|143024851|SUPERIORITY||Slope|3.39106||||0.39911|TWO_SIDED|95.0|-4.66|11.44||Assuming a 90% retention rate, enrolling 84 subjects in this cross-over trial will have 80% power to detect such an effect size in the intervention induced change of our study endpoints, with a two-sided α=0.05.|Mixed Models Analysis|||||11.44|-4.66|0.39911
71761612|NCT00689260|143024869|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Wilcoxon (Mann-Whitney)|||P-Value based on two-sided Wilcoxon rank-sum test for difference in medians between log aware and log unaware||||0.908
71761613|NCT02948634|143024886|SUPERIORITY|||||||0.43|||||||ANOVA|||||||0.43
71761614|NCT02948634|143024887|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
71761615|NCT02948634|143024888|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71761616|NCT01149148|143024889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3333|STANDARD_DEVIATION|1.626||0.678|TWO_SIDED|95.0|-1.36|2.02||A prior threshold for statistical significance is p \< 0.05|t-test, 2 sided||The difference between baseline and three months is (baseline - 3 month). The difference in control and intervention is (intervention - control), which in this case is (unblinded - blinded).|The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.||2.02|-1.36|0.678
71761617|NCT04881942|143024905|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|89.44||||0.0184|TWO_SIDED|95.0|15.77|163.11|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham)|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||163.11|15.77|0.0184
71761618|NCT04881942|143024905|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|195.7|||<|0.0001|TWO_SIDED|95.0|122.01|269.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||269.38|122.01|<.0001
71822391|NCT05310084|143146995|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.04|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Austria||1.04|0.77|
71822392|NCT05310084|143146995|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|B/Phuket||1.13|0.89|
71822393|NCT05310084|143146995|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H1N1 A/Victoria||1.09|0.83|
71774884|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.03|STANDARD_ERROR_OF_MEAN|2.06||0.6161|TWO_SIDED|95.0|-5.08|3.01|||ANCOVA|||Baseline sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.01|-5.08|0.6161
71761619|NCT04881942|143024905|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|168.83|||<|0.0001|TWO_SIDED|95.0|95.17|242.5|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||242.50|95.17|<.0001
71761620|NCT04881942|143024905|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|182.65|||<|0.0001|TWO_SIDED|95.0|108.63|256.67|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||256.67|108.63|<.0001
71761621|NCT04881942|143024908|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5972.3|||<|0.0001|TWO_SIDED|95.0|4191.1|7753.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7753.6|4191.1|<.0001
71761622|NCT04881942|143024908|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6099.5|||<|0.0001|TWO_SIDED|95.0|4317.8|7881.2|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7881.2|4317.8|<.0001
71761623|NCT04881942|143024908|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|6484.7|||<|0.0001|TWO_SIDED|95.0|4701.7|8267.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||8267.6|4701.7|<.0001
71774885|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.63|STANDARD_ERROR_OF_MEAN|1.62||0.3154|TWO_SIDED|95.0|-4.83|1.56|||ANCOVA|||Week 16 sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.56|-4.83|0.3154
71822394|NCT05310084|143146995|NON_INFERIORITY|Noninferiority was declared for an influenza strain if the lower bound of the 2-sided 95% CI for the GMR (coadministration group to separate administration group) was greater than 0.67.|GMR|0.96|||||TWO_SIDED|95.0|0.85|1.09|||||GMRs and 95% CIs were calculated by exponentiating LSmeans difference of logarithms of titers (coadministration group-separate administration group), corresponding CIs based on analysis of log transformed assay results using a linear regression model|H3N2 A/Darwin||1.09|0.85|
71822395|NCT02941146|143147002|OTHER||sucess proportion|64.3|||||TWO_SIDED|95.0|35.1|87.2||||||||87.2|35.1|
71822396|NCT01646320|143147005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.0964|<|0.0001|TWO_SIDED|95.0|-0.91|-0.53||Tested at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.53|-0.91|<0.0001
71822397|NCT01646320|143147006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|4.015|<|0.0001|TWO_SIDED|95.0|-35.4|-19.6||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-19.6|-35.4|<0.0001
71883237|NCT01877187|143286041|OTHER|||||||0.029||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.029
71883238|NCT01877187|143286041|OTHER|||||||0.94||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.94
71883239|NCT01877187|143286043|OTHER|||||||0.06||||||Statistical significance defined as p \<= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.06
71700331|NCT00855582|142916390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
71761624|NCT04881942|143024908|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|5366.8|||<|0.0001|TWO_SIDED|95.0|3575.9|7157.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||7157.7|3575.9|<.0001
71761625|NCT04881942|143024911|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.17||||0.915|TWO_SIDED|95.0|-2.92|3.25|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.25|-2.92|0.9150
71761626|NCT04881942|143024911|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.35||||0.8217|TWO_SIDED|95.0|-2.7|3.4|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3.40|-2.70|0.8217
71761627|NCT04881942|143024911|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|21.11|||<|0.0001|TWO_SIDED|95.0|18.06|24.16|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||24.16|18.06|<.0001
71761628|NCT04881942|143024911|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|31.01|||<|0.0001|TWO_SIDED|95.0|27.91|34.12|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||34.12|27.91|<.0001
71761629|NCT04881942|143024914|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1678.4||||0.0031|TWO_SIDED|95.0|592.14|2764.6|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2764.6|592.14|.0031
71774886|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.7|STANDARD_ERROR_OF_MEAN|3.18||0.593|TWO_SIDED|95.0|-7.94|4.54|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.54|-7.94|0.5930
71822398|NCT01646320|143147007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|5.493|<|0.0001|TWO_SIDED|95.0|-46.3|-24.7||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-24.7|-46.3|<0.0001
71822399|NCT01646320|143147008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3126|<|0.0001|TWO_SIDED|95.0|-2.12|-0.89||Secondary endpoints are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis|||||-0.89|-2.12|<0.0001
71883240|NCT01877187|143286043|OTHER|||||||0.013||||||Statistical significance defined as p \<= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.013
71700332|NCT00855582|142916390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.||||||<0.001
71700333|NCT00855582|142916391|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.027
71700334|NCT00855582|142916391|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA|||||||0.186
71761630|NCT04881942|143024914|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|1199.7||||0.031|TWO_SIDED|95.0|113.74|2285.7|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||2285.7|113.74|.0310
71761631|NCT04881942|143024914|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|3354.5|||<|0.0001|TWO_SIDED|95.0|2266.6|4442.3|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||4442.3|2266.6|<.0001
71761632|NCT04881942|143024914|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|2511.0|||<|0.0001|TWO_SIDED|95.0|1416.1|3605.9|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||3605.9|1416.1|<.0001
71761633|NCT04881942|143024917|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0002|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0.|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|.0002
71761634|NCT04881942|143024917|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.25||||0.0003|TWO_SIDED|95.0|0.12|0.38|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.38|0.12|0.0003
71761635|NCT04881942|143024917|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.47|0.21|<.0001
71761636|NCT04881942|143024917|EQUIVALENCE|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."|Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43|||ANCOVA||Mean value is sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham).|"Null Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is equal to 0.~Alternate Hypothesis: Mean sham-corrected (amount of analyte in test-product exhale minus analyte concentration in exhaled sham) analyte amount is not equal to 0."||0.43|0.17|<.0001
71761637|NCT04881942|143024924|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Final Values)|0.035|||<|0.0001|TWO_SIDED|95.0|0.031|0.039|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.039|0.031|<.0001
71822400|NCT01646320|143147009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|||<|0.0001|TWO_SIDED|95.0|16.7|34.4||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||34.4|16.7|<0.0001
71822401|NCT02424344|143147014|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.125||||0.069|TWO_SIDED|95.0|-0.259|0.01|||ANCOVA|Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors||||0.010|-0.259|0.069
71822402|NCT05257837|143147030|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71822403|NCT05257837|143147031|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71700335|NCT03345004|142916394|SUPERIORITY||Estimated ratio|1.091|||=|0.5009|TWO_SIDED|95.0|0.845|1.408|||Mixed Models Analysis|||||1.408|0.845|= 0.5009
71700336|NCT03345004|142916394|SUPERIORITY||Estimated ratio|1.557|||=|0.0078|TWO_SIDED|95.0|1.126|2.153|||Mixed Models Analysis|||||2.153|1.126|= 0.0078
71761638|NCT04881942|143024924|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.034|||<|0.0001|TWO_SIDED|95.0|0.03|0.038|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.038|0.030|<.0001
71761639|NCT04881942|143024924|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.04|||<|0.0001|TWO_SIDED|95.0|0.036|0.044|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.044|0.036|<.0001
71761640|NCT04881942|143024924|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.037|||<|0.0001|TWO_SIDED|95.0|0.033|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.033|<.0001
71761641|NCT04881942|143024925|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.031|0.04|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.040|0.031|<.0001
71761642|NCT04881942|143024925|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.036|||<|0.0001|TWO_SIDED|95.0|0.032|0.041|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.041|0.032|<.0001
71761643|NCT04881942|143024925|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.041|||<|0.0001|TWO_SIDED|95.0|0.037|0.046|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.046|0.037|<.0001
71761644|NCT04881942|143024925|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.038|||<|0.0001|TWO_SIDED|95.0|0.033|0.042|||ANOVA|||Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.042|0.033|<.0001
71761645|NCT04881942|143024926|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.536|||<|0.0001|TWO_SIDED|95.0|0.407|0.665|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.665|0.407|<.0001
71761646|NCT04881942|143024926|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.408|||<|0.0001|TWO_SIDED|95.0|0.28|0.537|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.537|0.280|<.0001
71761647|NCT04881942|143024926|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.468|||<|0.0001|TWO_SIDED|95.0|0.339|0.596|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.596|0.339|<.0001
71761648|NCT04881942|143024926|EQUIVALENCE|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.|Mean Difference (Net)|0.43|||<|0.0001|TWO_SIDED|95.0|0.301|0.559|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean cartridge weight change is equal to 0. Alternate Hypothesis: Mean cartridge weight change is not equal to 0.||0.559|0.301|<.0001
71761649|NCT04881942|143024928|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|277.79|||<|0.0001|TWO_SIDED|95.0|213.62|341.96|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||341.96|213.62|<.0001
71700337|NCT01013753|142916415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.097|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.182|0.097|<0.0001
71700338|NCT01013753|142916415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.14|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.224|0.140|<0.0001
71761650|NCT04881942|143024928|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|241.32|||<|0.0001|TWO_SIDED|95.0|176.99|305.64|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||305.64|176.99|<.0001
71761651|NCT04881942|143024928|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|248.22|||<|0.0001|TWO_SIDED|95.0|184.01|312.43|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||312.43|184.01|<.0001
71761652|NCT04881942|143024928|EQUIVALENCE|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0|Mean Difference (Final Values)|257.92|||<|0.0001|TWO_SIDED|95.0|193.58|322.26|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Puff Count is equal to 0 Alternative Hypothesis: Mean Puff Count is not equal to 0||322.26|193.58|<.0001
71822404|NCT05257837|143147032|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||.012
71761653|NCT04881942|143024929|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.223|||<|0.0001|TWO_SIDED|95.0|1.915|2.58|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.580|1.915|<.0001
71761654|NCT04881942|143024929|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.203|||<|0.0001|TWO_SIDED|95.0|1.897|2.557|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.557|1.897|<.0001
71761655|NCT04881942|143024929|EQUIVALENCE|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0|Mean Difference (Final Values)|2.101|||<|0.0001|TWO_SIDED|95.0|1.81|2.439|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.439|1.810|<.0001
71761656|NCT04881942|143024929|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|2.052|||<|0.0001|TWO_SIDED|95.0|1.767|2.382|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Average Puff Duration is equal to 0 Alternative Hypothesis: Mean Average Puff Duration is not equal to 0||2.382|1.767|<.0001
71761657|NCT04881942|143024930|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|709.86|||<|0.0001|TWO_SIDED|95.0|549.19|870.54|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||870.54|549.19|<.0001
71761658|NCT04881942|143024930|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|568.35|||<|0.0001|TWO_SIDED|95.0|407.18|729.51|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||729.51|407.18|<.0001
71761659|NCT04881942|143024930|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|562.0|||<|0.0001|TWO_SIDED|95.0|401.34|722.67|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||722.67|401.34|<.0001
71822405|NCT05257837|143147034|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||.217
71822406|NCT05257837|143147035|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||.745
71822407|NCT04731714|143147042|SUPERIORITY|||||||0.0104|||||||Mixed Models Analysis|See publication for details||||||0.0104
71822408|NCT04731714|143147043|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|See publication for details||||||0.079
71822409|NCT04731714|143147044|SUPERIORITY|||||||0.9222|||||||Mixed Models Analysis|See publication for details||||||0.9222
71761660|NCT04881942|143024930|EQUIVALENCE|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0|Mean Difference (Final Values)|517.23|||<|0.0001|TWO_SIDED|95.0|356.11|678.34|||ANCOVA||LSM calculated from mixed models. Each model includes fixed effect terms for product, period and sequence.|Null Hypothesis: Mean Total Puff Duration is equal to 0 Alternative Hypothesis: Mean Total Puff Duration is not equal to 0||678.34|356.11|<.0001
71761661|NCT02100696|143024955|SUPERIORITY||Adjusted difference in response rates|12.2||||0.0033|TWO_SIDED|95.0|3.95|17.67|||Cochran-Mantel-Haenszel|||||17.67|3.95|0.0033
71761662|NCT02100696|143024956|SUPERIORITY||Treatment Difference|3.8||||0.4956|TWO_SIDED|95.0|-7.13|14.56|||Cochran-Mantel-Haenszel|||||14.56|-7.13|0.4956
71761663|NCT02100696|143024957|SUPERIORITY||Adjusted Difference in Remission Rates|12.5||||0.0028|TWO_SIDED|95.0|4.19|17.94||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.94|4.19|0.0028
71761664|NCT02100696|143024958|SUPERIORITY||Adjusted Difference in Response Rates|14.3||||0.0241|TWO_SIDED|95.0|3.21|24.14||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||24.14|3.21|0.0241
71822410|NCT04731714|143147045|SUPERIORITY|||||||0.7995|||||||Mixed Models Analysis|See publication for details||||||0.7995
71822411|NCT04731714|143147046|OTHER|||||||0.314||||||rhythmic days|Friedman Test|See publication for further details||||||0.3140
71822412|NCT04731714|143147046|OTHER|||||||0.239||||||arrhythmic days|Friedman Test|See publication for further details||||||0.239
71822413|NCT04731714|143147050|SUPERIORITY|||||||0.8844|||||||Mixed Models Analysis|See publication for details||||||0.8844
71822414|NCT04731714|143147052|OTHER|||||||0.73|||||||binomial|One-sided||||||0.73
71822415|NCT02037061|143147079|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
71822416|NCT01341080|143147109|OTHER||Cohen's d|0.15||||0.05|TWO_SIDED|95.0|-4.01|4.61|||Repeated measures analysis or variance|||Efficacy was measured as a change on the Berg Balance Scale (BBS) from baseline to the end of study after 8 weeks on drug. The BBS has a scale range of 0-56, with 56 indicating normal balance. To evaluate efficacy, repeated measures analysis of variance was run on BBS scores. The scale score was the dependent measure, time point (baseline or end of study) was the repeat measure, and treatment group (varenicline or sugar pill) was the independent measure. Significance was defined as alpha \<0.05.||4.61|-4.01|0.05
71822417|NCT01341080|143147110|OTHER||Cohen's d|0.16||||0.05|TWO_SIDED|95.0|-1.39|1.53|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Frontal Assessment Battery (FAB) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the FAB scores. Scale cores was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.53|-1.39|0.05
71890326|NCT03952559|143302139|SUPERIORITY||LS Mean difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8133|TWO_SIDED|95.0|-0.79|0.62|||Mixed Models Analysis|||||0.62|-0.79|0.8133
71822418|NCT01341080|143147111|OTHER||Cohen's d|0.81||||0.05|TWO_SIDED|95.0|-0.4|1.4|||Repeated measures analysis or variance|||Change in cognitive functioning was measured in part with the Mini Mental State Exam (MMSE) from Baseline to 8 weeks on drug. Repeated analysis of variance was run on the MMSE scores. Scale score was the dependent measure, time point (Baseline or end of study) was the repeated measure, and treatment group (varenicline or sugar pill) was the independent measure. Significant was defined as \<0.05.||1.40|-0.40|0.05
71761665|NCT02100696|143024959|SUPERIORITY||Adjusted Difference in Response Rates|8.1||||0.1605|TWO_SIDED|95.0|-2.54|17.22||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||17.22|-2.54|0.1605
71761666|NCT02100696|143024960|SUPERIORITY||Adjusted Difference in Remission Rates|7.6||||0.3881|TWO_SIDED|95.0|-1.22|13.66||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||13.66|-1.22|0.3881
71761667|NCT02100696|143024961|SUPERIORITY||Adjusted Difference in Remission Rates|4.9||||0.5879|TWO_SIDED|95.0|-6.78|14.69||Multiplicity P-value reported (adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.69|-6.78|0.5879
71761668|NCT02100696|143024962|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.0351|TWO_SIDED|95.0|-0.5|0.0||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||-0.0|-0.5|0.0351
71761669|NCT02100696|143024963|SUPERIORITY||Difference in Unadjusted Means|-0.2||||0.2698|TWO_SIDED|95.0|-0.4|0.1||Multiplicity P-value reported (adjusted for multiplicity)|ANCOVA|||||0.1|-0.4|0.2698
71761670|NCT02100696|143024964|SUPERIORITY||Difference in Least Square Means|-1.6||||0.2698|TWO_SIDED|95.0|-2.9|-0.3||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||-0.3|-2.9|0.2698
71761671|NCT02100696|143024965|SUPERIORITY||Difference in Least Square Means|-0.5||||0.3881|TWO_SIDED|95.0|-1.0|0.0||Multiplicity P-value reported (adjusted for multiplicity)|Mixed Models Analysis|||||0.0|-1.0|0.3881
71761672|NCT02100696|143024966|SUPERIORITY||Difference in Adjusted Means|9.1||||0.0445|TWO_SIDED|95.0|0.2|17.9||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||17.9|0.2|0.0445
71761673|NCT02100696|143024967|SUPERIORITY||Adjusted Difference in Remission Rates|0.1||||0.9959|TWO_SIDED|95.0|-19.67|19.88||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||19.88|-19.67|0.9959
71761674|NCT02100696|143024968|SUPERIORITY||Adjusted Difference in Remission Rates|3.8||||0.5014|TWO_SIDED|95.0|-7.26|14.7||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||14.70|-7.26|0.5014
71761675|NCT02100696|143024969|SUPERIORITY||Adjusted Difference in Remission Rates|0.6||||0.9538|TWO_SIDED|95.0|-19.08|20.35||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||20.35|-19.08|0.9538
71761676|NCT02100696|143024970|SUPERIORITY||Adjusted Difference in Response Rates|14.5||||0.0153|TWO_SIDED|95.0|2.66|25.78||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||25.78|2.66|0.0153
71761677|NCT02100696|143024971|SUPERIORITY||Adjusted Difference in Remission Rates|16.8||||0.0073|TWO_SIDED|95.0|4.44|28.41||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||28.41|4.44|0.0073
71761678|NCT02100696|143024972|SUPERIORITY||Adjusted Difference in Remission Rates|11.9||||0.0174|TWO_SIDED|95.0|1.87|21.71||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.71|1.87|0.0174
71761679|NCT02100696|143024973|SUPERIORITY||Adjusted Difference in Remission Rates|7.3||||0.3015|TWO_SIDED|95.0|-6.83|21.6||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.60|-6.83|0.3015
71761680|NCT02100696|143024974|SUPERIORITY||Adjusted Difference in Remission Rates|7.4||||0.2787|TWO_SIDED|95.0|-6.23|21.17||Nominal P-value reported (not adjusted for multiplicity)|Cochran-Mantel-Haenszel|||||21.17|-6.23|0.2787
71761681|NCT02100696|143024975|SUPERIORITY||Difference in Least Square Means|-1.5||||0.0763|TWO_SIDED|95.0|-3.1|0.2||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.2|-3.1|0.0763
71761682|NCT02100696|143024976|SUPERIORITY||Difference in Least Square Means|-0.2||||0.5329|TWO_SIDED|95.0|-1.0|0.5||Nominal P-value reported (not adjusted for multiplicity)|Mixed Models Analysis|||||0.5|-1.0|0.5329
71761683|NCT02100696|143024977|SUPERIORITY||Difference in Adjusted Means|-4.9||||0.2228|TWO_SIDED|95.0|-12.7|3.0||Nominal P-value reported (not adjusted for multiplicity)|ANCOVA|||||3.0|-12.7|0.2228
71761684|NCT00078897|143024989|OTHER|Negative binomial regression|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.91|1.16|||Negative binomial regression|||||1.16|0.91|0.68
71761685|NCT00048074|143025014|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (2mg q 2 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.257|||<|0.001|TWO_SIDED|95.0|0.701|1.814|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.814|0.701|<0.001
71883241|NCT01877187|143286043|OTHER|||||||0.67||||||Statistical significance defined as p \<= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.||||0.67
71761686|NCT00048074|143025014|NON_INFERIORITY_OR_EQUIVALENCE|The IV dosing regimen (3mg q 3 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.025|||<|0.001|TWO_SIDED|95.0|0.471|1.578|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 - L4) was small, no more than 1%, the margin of clinical equivalence.||1.578|0.471|<0.001
71761687|NCT01032889|143025048|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3||||0.052|TWO_SIDED|95.0|-0.61|0.0|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.00|-0.61|0.052
71761688|NCT01032889|143025048|SUPERIORITY_OR_OTHER||Difference from placebo|-0.5||||0.003|TWO_SIDED|95.0|-0.77|-0.16|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.16|-0.77|0.003
71822419|NCT02400307|143147148|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|Geometric Least-Square Mean (GLSM) Ratio|72.63|||||TWO_SIDED|90.0|48.8|108.1||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.10|48.80|
71700339|NCT01013753|142916415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.163|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.248|0.163|<0.0001
71761689|NCT01032889|143025049|SUPERIORITY_OR_OTHER||Difference from placebo|-0.2||||0.117|TWO_SIDED|95.0|-0.55|0.06|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||0.06|-0.55|0.117
71761690|NCT01032889|143025049|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|||<|0.001|TWO_SIDED|95.0|-0.91|-0.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.30|-0.91|<0.001
71761691|NCT01032889|143025050|SUPERIORITY_OR_OTHER||Difference from placebo|-1.4||||0.005|TWO_SIDED|95.0|-2.44|-0.46|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-0.46|-2.44|0.005
71761692|NCT01032889|143025050|SUPERIORITY_OR_OTHER||Difference from placebo|-2.5|||<|0.001|TWO_SIDED|95.0|-3.48|-1.48|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.||-1.48|-3.48|<0.001
71761693|NCT01032889|143025051|SUPERIORITY_OR_OTHER||Difference from placebo|-606.0||||0.166|TWO_SIDED|95.0|-1482.0|269.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||269.3|-1482|0.166
71761694|NCT01032889|143025051|SUPERIORITY_OR_OTHER||Difference from placebo|-110.0||||0.803|TWO_SIDED|95.0|-1013.0|792.6|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||792.6|-1013|0.803
71761695|NCT01032889|143025052|SUPERIORITY_OR_OTHER||Difference from placebo|-1.5|||<|0.001|TWO_SIDED|95.0|-2.32|-0.69|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.69|-2.32|<0.001
71761696|NCT01032889|143025052|SUPERIORITY_OR_OTHER||Difference from placebo|-1.7|||<|0.001|TWO_SIDED|95.0|-2.46|-0.85|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||||-0.85|-2.46|<0.001
71761697|NCT00740857|143025073|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71761698|NCT00740857|143025073|SUPERIORITY_OR_OTHER|||||||0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||0.001
71822420|NCT02400307|143147149|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.29|||||TWO_SIDED|90.0|79.49|124.04||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||124.04|79.49|
71761699|NCT00740857|143025073|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71761700|NCT00740857|143025074|SUPERIORITY_OR_OTHER|||||||0.118|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.118
71761701|NCT00740857|143025074|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60....||||<0.001
71761702|NCT00740857|143025075|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.041
71761703|NCT00740857|143025075|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
71761704|NCT00740857|143025076|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71700340|NCT01013753|142916415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.186|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.272|0.186|<0.0001
71761705|NCT00740857|143025077|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes||||0.056
71761706|NCT00740857|143025077|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.||||<0.001
71761707|NCT00740857|143025078|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71761708|NCT00740857|143025079|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71761709|NCT00740857|143025080|SUPERIORITY_OR_OTHER||||||<|0.001|||||||proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||||||<0.001
71761710|NCT03532451|143025087|SUPERIORITY|||||||0.08|||||||Wilcoxon Signed-Rank Test|||Null hypothesis is the change in CD8+ cell density is not significantly different from zero.||||0.08
71761711|NCT03532451|143025087|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank Test|||||||0.002
71761712|NCT03532451|143025088|SUPERIORITY|||||||0.88|||||||Wilcoxon rank sum test|||||||0.88
71761713|NCT02654769|143025099|EQUIVALENCE|Difference (Generic- Picato)|90% Wald's confidence interval|-1.87|||<|0.0001|TWO_SIDED|90.0|-12.37|8.63|||Fisher Exact|||||8.63|-12.37|<0.0001
71883242|NCT04749459|143286062|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Classic: CIs +/- 13.7% P2 Control Standard (vs. CSM Classic) CIs +/- 16.4%|||
71883243|NCT04749459|143286062|OTHER|A minimum of 10 valid results was defined as the number required to produce mean study product (or control standard) SPF with 95% confidence interval (CI) within +/- 17% of the measured mean SPF of the study product (or control standard).|||||||||||||||||CSM Strawberry Flavor: CIs +/- 16.6% P2 Control Standard (vs CSM Strawberry Flavour): CIs +/- 16.0%|||
71883244|NCT02970292|143286106|SUPERIORITY||Difference in MMRM LSMs|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.094|TWO_SIDED|95.0|-4.5|0.4|||mixed-effects model for repeated measure|||||0.4|-4.5|0.0940
71761714|NCT02654769|143025100|EQUIVALENCE|Difference (Generic - Picato)|90% Wald's confidence interval|-2.64|||<|0.0001|TWO_SIDED|90.0|-13.14|7.86|||Fisher Exact|||Partial Clearance at Week 8||7.86|-13.14|<0.0001
71761715|NCT00233064|143025144|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.0||||||95.0|0.0|1.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.9|0.0|
71883245|NCT00513500|143286115|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.32||||||95.0|2.19|8.94||||||||8.94|2.19|
71883246|NCT00513500|143286116|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||||95.0|0.14|0.38||||||||0.38|0.14|
71761716|NCT00233064|143025144|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.5||||||95.0|0.0|2.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||2.9|0.0|
71883247|NCT00513500|143286117|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.44||||||95.0|0.21|0.93||||||||0.93|0.21|
71883248|NCT00749996|143286122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.228|TWO_SIDED|95.0|-1.59|0.38|||t-test, 2 sided|||The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.||0.38|-1.59|0.228
71883249|NCT00749996|143286123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.719|TWO_SIDED|95.0|-8.8|6.08|||t-test, 2 sided|||The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.||6.08|-8.80|0.719
71700341|NCT01013753|142916415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.126|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.126|<0.0001
71761717|NCT00233064|143025144|SUPERIORITY_OR_OTHER||Overall percentage of immune reactivity|0.3||||||95.0|0.0|1.5|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of \<2-3% based on 95% confidence intervals \[(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)\].||1.5|0.0|
71761718|NCT03508908|143025149|OTHER||US dollars per DALY averted|3098.0|||||TWO_SIDED||||||||Cost (in US dollars) per DALY averted (Intervention referenced to Observation)|Cost (in US dollars) per DALY averted (Intervention referenced to Observation)||||
71883250|NCT00606086|143286124|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Mantel-Haenszel test|||||||1.000
71883251|NCT02692495|143286128|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71883252|NCT00708123|143286177|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.97||||0.0265|TWO_SIDED|95.0|0.47|7.48||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||7.48|0.47|0.0265
71883253|NCT00708123|143286177|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.66||||0.0017|TWO_SIDED|95.0|2.15|9.18||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors as treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||9.18|2.15|0.0017
71883254|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|-1.69||||0.3413|TWO_SIDED|95.0|-5.19|1.8||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1.80|-5.19|0.3413
71774887|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|10.02|STANDARD_ERROR_OF_MEAN|2.42|<|0.0001|TWO_SIDED|95.0|5.27|14.76|||ANCOVA|||Week 16 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||14.76|5.27|<0.0001
71890221|NCT03529409|143302028|SUPERIORITY||Mean Difference (Net)|3.3||||0.63|TWO_SIDED|95.0|-10.5|17.1||The overall omnibus test of the time by treatment interaction was p=.66. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||17.1|-10.5|.63
71890327|NCT03952559|143302139|SUPERIORITY||LS Mean difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.355||0.2517|TWO_SIDED|95.0|-1.11|0.29|||Mixed Models Analysis|||||0.29|-1.11|0.2517
71883255|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.26|||<|0.0001|TWO_SIDED|95.0|6.76|13.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||13.76|6.76|<0.0001
71700342|NCT01013753|142916416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.116|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.211|0.116|<0.0001
71761719|NCT01120964|143025168|OTHER|Analyses presented herein are for re-intubation time included.|Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||"Total duration of postoperative invasive mechanical ventilation was analyzed by treatment group using summary statistics, and was compared between citrulline and placebo groups using an ANOVA.~Kaplan-Meier analyses were performed for: 1) zero durations censored, 2) zero durations uncensored, 3) patients with zero duration excluded. The same analyses were performed with re-intubation time removed."||73.4|-9.5|0.0222
71761720|NCT01120964|143025169|OTHER||Mean Difference (Final Values)|32.0||||0.0222|TWO_SIDED|95.0|-9.5|73.4||Re-intubation time included. Threshold for significance was p\<0.05|t-test, 2 sided|||Analyses presented herein are for re-intubation time included.||73.4|-9.5|0.0222
71761721|NCT01120964|143025170|OTHER||Mean Difference (Final Values)|50.7||||0.0418|TWO_SIDED|95.0|5.4|96.0||The threshold for significance was P\<0.05|Wilcoxon (Mann-Whitney)|||||96.0|5.4|0.0418
71761722|NCT01120964|143025171|OTHER||Mean Difference (Final Values)|12.7||||0.0727|TWO_SIDED|95.0|-2.6|28.1||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||28.1|-2.6|0.0727
71761723|NCT01120964|143025172|OTHER||Mean Difference (Final Values)|559.8||||0.1271|TWO_SIDED|95.0|-193.5|1313.2|||Wilcoxon (Mann-Whitney)|||||1313.2|-193.5|0.1271
71761724|NCT01120964|143025173|OTHER||Mean Difference (Final Values)|3.5||||0.972|TWO_SIDED|95.0|-7.0|14.1|||Wilcoxon (Mann-Whitney)|||||14.1|-7.0|0.9720
71761725|NCT01120964|143025174|OTHER||Mean Difference (Final Values)|5.2||||0.8884|TWO_SIDED|95.0|-7.7|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-7.7|0.8884
71761726|NCT01120964|143025175|OTHER|Total number of postoperative hours spent in PICU|Mean Difference (Final Values)|69.14||||0.1891|TWO_SIDED|95.0|-49.39|187.67||The threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||187.67|-49.39|0.1891
71761727|NCT01120964|143025176|OTHER||Mean Difference (Final Values)|30.2||||0.0479|TWO_SIDED|95.0|-10.8|71.1||Duration including re-intubation time. Threshold for significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||71.1|-10.8|0.0479
71761728|NCT01120964|143025177|OTHER||Mean Difference (Final Values)|3.7||||0.2637|TWO_SIDED|95.0|-2.2|9.7|||Wilcoxon (Mann-Whitney)|||||9.7|-2.2|0.2637
71761729|NCT01120964|143025179|OTHER||Mean Difference (Final Values)|7.5||||0.6431|TWO_SIDED|95.0|-25.9|41.0|||t-test, 2 sided|||||41.0|-25.9|0.6431
71761730|NCT01120964|143025180|OTHER||Mean Difference (Final Values)|39.5||||0.6408|TWO_SIDED|95.0|-134.2|213.1|||ANOVA|||||213.1|-134.2|0.6408
71761731|NCT00826202|143025192|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|cohen's d= 0.67||||||0.07
71761732|NCT00826202|143025193|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED||||||t-test, 2 sided|cohen's d=0.84||||||.056
71761733|NCT00826202|143025194|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Cohen's d=0.68||||||0.03
71761734|NCT00826202|143025195|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|cohen's d=0.93||||||0.12
71761735|NCT00829504|143025206|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.16||||||90.0|95.5|105.04|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.04|95.5|
71761736|NCT00829504|143025207|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.76||||||90.0|95.45|108.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.49|95.45|
71761737|NCT00829504|143025208|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.1||||||90.0|95.64|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|95.64|
71761738|NCT00912197|143025218|SUPERIORITY|||||||0.135|||||||ANCOVA|||||||0.135
71761739|NCT00912197|143025219|SUPERIORITY|||||||0.688|||||||ANCOVA|||||||0.688
71761740|NCT00912197|143025220|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||after treatment, 56 days||||0.715
71761741|NCT00912197|143025221|SUPERIORITY|||||||0.578|||||||ANCOVA|||||||0.578
71761742|NCT00912197|143025221|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||baseline to after treatment, at 56 days||||0.007
71761743|NCT00912197|143025221|SUPERIORITY|||||||0.05||||||calculated|t-test, 2 sided|||baseline to after treatment, at 56 days||||0.05
71761744|NCT00912197|143025225|SUPERIORITY|||||||0.024|||||||ANCOVA|||Acetate||||0.024
71822421|NCT02400307|143147150|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|72.43|||||TWO_SIDED|90.0|48.54|108.07||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.07|48.54|
71890222|NCT03529409|143302029|SUPERIORITY||Mean Difference (Net)|-0.03||||0.85|TWO_SIDED|95.0|-0.34|0.28||The overall omnibus test of the time by treatment interaction was p=.94. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||.28|-.34|.85
71883256|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.19|||<|0.0001|TWO_SIDED|95.0|9.69|16.68||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||16.68|9.69|<0.0001
71883257|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.57|||<|0.0001|TWO_SIDED|95.0|5.09|12.05||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||12.05|5.09|<0.0001
71883258|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.5|||<|0.0001|TWO_SIDED|95.0|8.01|14.98||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||14.98|8.01|<0.0001
71883259|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.59||||0.0104|TWO_SIDED|95.0|-8.1|-1.09||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-1.09|-8.10|0.0104
71883260|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.52|||<|0.0001|TWO_SIDED|95.0|4.04|11.01||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||11.01|4.04|<0.0001
71883261|NCT00708123|143286178|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|2.93||||0.0986|TWO_SIDED|95.0|-0.55|6.41||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||6.41|-0.55|0.0986
71761745|NCT00756613|143025230|EQUIVALENCE|We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.|Cox Proportional Hazard|0.91||||0.24|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.||1.06|0.78|0.24
71883262|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|196.74||||0.0148|TWO_SIDED|95.0|38.89|354.6||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.||354.60|38.89|0.0148
71943912|NCT00840632|143409984|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|93.26||||||90.0|83.39|104.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.31|83.39|
71700343|NCT01013753|142916416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.166|0.259|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.259|0.166|<0.0001
71883263|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|246.7||||0.0024|TWO_SIDED|95.0|88.3|405.1||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||405.10|88.30|0.0024
71883264|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.96||||0.5328|TWO_SIDED|95.0|-207.62|107.71||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||107.71|-207.62|0.5328
71883265|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-406.19|||<|0.0001|TWO_SIDED|95.0|-564.0|-248.37||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||-248.37|-564.00|<0.0001
71761746|NCT00756613|143025231|EQUIVALENCE|The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.|Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.88|1.18|||Regression, Cox|||||1.18|0.88|0.81
71761747|NCT00756613|143025232|EQUIVALENCE|The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.|Cox Proportional Hazard|0.9||||0.48|TWO_SIDED|95.0|0.67|1.2|||Regression, Cox|||||1.20|0.67|0.48
71883266|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|602.93|||<|0.0001|TWO_SIDED|95.0|445.97|759.9||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||759.90|445.97|<0.0001
71883267|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|652.89|||<|0.0001|TWO_SIDED|95.0|495.05|810.72||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||810.72|495.05|<0.0001
71883268|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|847.55|||<|0.0001|TWO_SIDED|95.0|690.54|1004.55||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1004.55|690.54|<0.0001
71883269|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|897.5|||<|0.0001|TWO_SIDED|95.0|739.92|1055.08||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors treatment, period and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||1055.08|739.92|<0.0001
71883270|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|650.8|||<|0.0001|TWO_SIDED|95.0|493.61|808.0||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||808.00|493.61|<0.0001
71883271|NCT00708123|143286179|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|244.62||||0.0024|TWO_SIDED|95.0|87.62|401.61||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.||401.61|87.62|0.0024
71883272|NCT00533442|143286206|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Kidney (logrank test).||||0.01
71883273|NCT00533442|143286206|SUPERIORITY|||||||0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Pancreas (logrank test).||||0.01
71883274|NCT00533442|143286206|SUPERIORITY|||||||0.16|||||||Log Rank|||Death-Censored Kidney Graft Failure (logrank test).||||0.16
71883275|NCT00533442|143286206|SUPERIORITY|||||||0.12|||||||Log Rank|||Death-Censored Pancreas Graft Failure (logrank test).||||0.12
71883276|NCT00533442|143286206|SUPERIORITY|||||||0.96|||||||Log Rank|||Death-Uncensored (Kidney \& Pancreas) Graft Survival (logrank test).||||0.96
71883277|NCT00533442|143286206|SUPERIORITY||||||>|0.99||||||Patient Death (logrank test).|Log Rank|||||||>0.99
71700344|NCT01013753|142916416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.186|0.28|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.280|0.186|<0.0001
71700345|NCT01013753|142916416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.203|0.298|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.298|0.203|<0.0001
71883278|NCT00533442|143286207|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Comparison of Mean eGFR at 12 Months Post-Transplant (t-test).||||0.21
71883279|NCT00533442|143286207|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Comparison of Mean eGFR at 36 Months Post-Transplant (t-test).||||0.71
71883280|NCT00533442|143286207|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Comparison of Mean eGFR at 60 Months Post-Transplant (t-test).||||0.33
71883281|NCT00533442|143286208|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 12 Months Post-Transplant (t-test).||||.47
71883282|NCT00533442|143286208|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 36 Months Post-Transplant (t-test).||||0.97
71883283|NCT00533442|143286208|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 60 Months Post-Transplant (t-test).||||0.75
71883284|NCT01119248|143286212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.62|<|0.001|TWO_SIDED|95.0|-0.48|-0.25|||t-test, 2 sided|||||-0.25|-0.48|<.001
71883285|NCT01119248|143286213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0001|TWO_SIDED|95.0|-0.95|-0.43|||t-test, 2 sided|||pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRI||-0.43|-0.95|0.0001
71883286|NCT01119248|143286214|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71883287|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.39|0.84|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.84|0.39|
71890328|NCT03952559|143302139|SUPERIORITY||LS Mean difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.0803|TWO_SIDED|95.0|-1.32|0.08|||Mixed Models Analysis|||||0.08|-1.32|0.0803
71890329|NCT01870739|143302147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0616||||0.7324|TWO_SIDED|95.0|-0.4178|0.2947|||Linear Model|Treatment as fixed effect and corresponding baseline as covariate.||||0.2947|-0.4178|0.7324
71883288|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.01|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.01|0.54|
71883289|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.5|1.11|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.11|0.50|
71883290|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.38|0.9|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.38|
71883291|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.37|0.74|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.37|
71883292|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.52|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.52|
71883293|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.46|0.95|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.95|0.46|
71883294|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.45|1.25|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.25|0.45|
71883295|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.7|||||TWO_SIDED|95.0|0.54|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.02|0.54|
71883296|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.35|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.35|
71883297|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.34|0.67|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.67|0.34|
71890330|NCT01870739|143302148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0371||||0.8614|TWO_SIDED|95.0|-0.4582|0.3839|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.3839|-0.4582|0.8614
71890331|NCT01870739|143302149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.0812||||0.7946|TWO_SIDED|95.0|-0.6987|0.5362|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate||||0.5362|-0.6987|0.7946
71761748|NCT00756613|143025234|EQUIVALENCE|T-test comparing between the two groups of treatment using the average score of last two surveys.|Mean Difference (Final Values)|1.61||||0.172|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.172
71700346|NCT01013753|142916416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.137|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.231|0.137|<0.0001
71822422|NCT02400307|143147151|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.02|||||TWO_SIDED|90.0|79.24|123.74||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||123.74|79.24|
71761749|NCT03801044|143025236|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71761750|NCT01326104|143025260|SUPERIORITY||comparing two curves|0.286||||0.927|TWO_SIDED|90.0|0.107|0.764||This is the p-value comparing Group A with historical control.|Log Rank|One sample log rank.||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||0.764|0.107|0.927
71822423|NCT02400307|143147152|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|80.32|||||TWO_SIDED|90.0|59.56|108.3||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||108.30|59.56|
71822424|NCT02400307|143147153|EQUIVALENCE|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|109.8|||||TWO_SIDED|90.0|87.46|137.85||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.||137.85|87.46|
71822425|NCT03248440|143147156|SUPERIORITY|||||||0.579|||||||2-sided Pearson's chi-square|||||||0.579
71761751|NCT01326104|143025260|SUPERIORITY||compare two curves|0.0|||<|0.001|TWO_SIDED|||||This is the p-value comparing Group B with historical control.|Log Rank|||Based on published literature, PFS-12 for patients with recurrent disease after initiating treatment with HDC + PBSCT or standard salvage therapy was 33% (95% confidence interval of 10%, 59%). The study was designed to differentiate between a PFS-12 rate of 33% (null hypothesis) and 55% (alternative hypothesis). If 35 patients enrolled, this assessment has 90% power assuming a type I error rate of 0.10. We assume that PFS of historical controls follows exponential distribution.||||<0.001
71761752|NCT01326104|143025260|SUPERIORITY||Comparing two curves|0.091|||<|0.001|TWO_SIDED|90.0|0.03|0.276||This is the p-value comparing Groups A and B combined with historical control.|Log Rank|||||0.276|0.03|<0.001
71761753|NCT01287741|143025266|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4753|TWO_SIDED|95.0|0.78|1.12|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.12|0.78|0.4753
71761754|NCT01287741|143025267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2736|TWO_SIDED|95.0|0.72|1.1|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low-intermediate (excluding participants having an IPI score 0 without bulky disease).||||1.10|0.72|0.2736
71761755|NCT04421027|143025282|SUPERIORITY||Odds Ratio (OR)|0.85||||0.18|TWO_SIDED|95.0|0.67|1.08|||Regression, Logistic|||||1.08|0.67|0.1800
71761756|NCT04421027|143025283|SUPERIORITY||Odds Ratio (OR)|1.12||||0.728|TWO_SIDED|95.0|0.58|2.16|||Regression, Logistic|||||2.16|0.58|0.7280
71761757|NCT04421027|143025284|SUPERIORITY||Odds Ratio (OR)|1.07||||0.5444|TWO_SIDED|95.0|0.86|1.34|||Regression, Logistic|||||1.34|0.86|0.5444
71761758|NCT04421027|143025285|SUPERIORITY||LS Mean difference (net)|0.75|STANDARD_ERROR_OF_MEAN|0.399||0.0586|TWO_SIDED|95.0|0.0|1.5|||ANOVA|||||1.5|-0.0|0.0586
71761759|NCT04421027|143025286|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1453|TWO_SIDED|95.0|0.99|1.24|||Log Rank|||||1.24|0.99|0.1453
71700347|NCT01013753|142916417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.073|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.158|0.073|<0.0001
71700348|NCT01013753|142916417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
71761760|NCT04421027|143025287|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0464|TWO_SIDED|95.0|1.0|1.47|||Proportional Odds Model|||Day 4||1.47|1.00|0.0464
71761761|NCT04421027|143025288|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0172|TWO_SIDED|95.0|1.04|1.49|||Proportional Odds Model|||||1.49|1.04|0.0172
71761762|NCT04421027|143025289|SUPERIORITY||Odds Ratio (OR)|1.17||||0.0921|TWO_SIDED|95.0|0.97|1.41|||Proportional Odds Model|||||1.41|0.97|0.0921
71761763|NCT04421027|143025290|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0168|TWO_SIDED|95.0|1.05|1.56|||Proportional Odds Model|||||1.56|1.05|0.0168
71761764|NCT04421027|143025291|SUPERIORITY||LS Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.408||0.0626|TWO_SIDED|95.0|-1.6|0.0|||ANOVA|||||0.0|-1.6|0.0626
71761765|NCT04421027|143025292|SUPERIORITY||Odds Ratio (OR)|1.15||||0.429|TWO_SIDED|95.0|0.81|1.63|||Regression, Logistic|||||1.63|0.81|0.4290
71761766|NCT04421027|143025293|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0018|TWO_SIDED|95.0|0.41|0.78|||Log Rank|||||0.78|0.41|0.0018
71761767|NCT04421027|143025294|SUPERIORITY||LS Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.323||0.9526|TWO_SIDED|95.0|-0.62|0.65|||ANOVA|||||0.65|-0.62|0.9526
71761768|NCT04421027|143025295|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.1831|TWO_SIDED|95.0|0.741|1.061|||Log Rank|||||1.061|0.741|0.1831
71761769|NCT04421027|143025296|SUPERIORITY||Hazard Ratio (HR)|1.202||||0.0243|TWO_SIDED|95.0|1.017|1.421|||Log Rank|||||1.421|1.017|0.0243
71761770|NCT04421027|143025297|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.128||0.191|TWO_SIDED|95.0|-0.42|0.08|||Mixed Models Analysis|||Day 4||0.08|-0.42|0.191
71761771|NCT04421027|143025297|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.278|TWO_SIDED|95.0|-0.49|0.14|||Mixed Models Analysis|||Day 7||0.14|-0.49|0.278
71761772|NCT04421027|143025297|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.496|TWO_SIDED|95.0|-0.49|0.24|||Mixed Models Analysis|||Day 10||0.24|-0.49|0.496
71761773|NCT04421027|143025297|SUPERIORITY||LS Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.226||0.263|TWO_SIDED|95.0|-0.7|0.19|||Mixed Models Analysis|||Day 14||0.19|-0.70|0.263
71761774|NCT04421027|143025299|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6436|TWO_SIDED||||||Log Rank|||||||0.6436
71761775|NCT04421027|143025300|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.127|TWO_SIDED||||||Log Rank|||||||0.1270
71761776|NCT04421027|143025301|SUPERIORITY||LS Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3058|TWO_SIDED|95.0|-0.68|0.21|||ANOVA|||||0.21|-0.68|0.3058
71761777|NCT04421027|143025302|SUPERIORITY||LS Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.306||0.7073|TWO_SIDED|95.0|-0.49|0.72|||ANOVA|||||0.72|-0.49|0.7073
71822426|NCT03248440|143147157|SUPERIORITY|||||||0.082|||||||2-sided Pearson's chi-square|||||||0.082
71822427|NCT01052662|143147158|SUPERIORITY_OR_OTHER||Slope|-0.00935|STANDARD_ERROR_OF_MEAN|0.00356|=|0.00874|TWO_SIDED||||||Mixed Models Analysis||Z = -2.62209|We modeled the mean proportion of weekly opioid use using a mixed-effect linear regression approach to assess the treatment effect, the time effect and the interaction of time x treatment effect while adjusting for the baseline mean proportion of weekly opioid use with baseline COWS, Addiction Severity Index (ASI) psychiatric and legal composite scores as covariates.||||=0.00874
71700349|NCT01013753|142916417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.135|<0.0001
71761778|NCT02930018|143025329|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS (Acute Ischemic Stroke) patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.146||||0.335|TWO_SIDED|95.0|0.869|1.511||2 sided 0.05 significance level.|Regression, Logistic|||The primary hypothesis was that administration of nerinetide (NA-1) would result in an increase in the proportion of responders. The primary analysis was a Wald test for treatment group difference in the primary outcome from a logistic regression adjusted for the 2 stratification variables (alteplase use, first declared thrombectomy device), and the 6 covariates used in the minimization. The trial was designed to have 80% power to detect an 8.7% absolute difference between groups.||1.511|0.869|0.335
71761779|NCT02930018|143025330|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.024||||0.866|TWO_SIDED|95.0|0.781|1.342||2 sided 0.05 significance level.|Regression, Logistic|||||1.342|0.781|0.866
71761780|NCT02930018|143025331|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.776||||0.199|TWO_SIDED|95.0|0.527|1.143||2 sided 0.05 significance level.|Regression, Logistic|||||1.143|0.527|0.199
71761781|NCT02930018|143025332|SUPERIORITY||Odds Ratio (OR)|1.657||||0.028|TWO_SIDED|95.0|1.055|2.603|||Regression, Logistic|||||2.603|1.055|0.028
71761782|NCT02930018|143025332|SUPERIORITY||Absolute Risk Difference (%)|9.6|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71761783|NCT02930018|143025332|SUPERIORITY||Relative Risk Difference (%)|19.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71761784|NCT02930018|143025333|SUPERIORITY||Odds Ratio (OR)|1.482||||0.088|TWO_SIDED|95.0|0.943|2.329|||Regression, Logistic|||||2.329|0.943|0.088
71761785|NCT02930018|143025333|SUPERIORITY||Absolute Risk Difference (%)|9.1|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71761786|NCT02930018|143025333|SUPERIORITY||Relative Risk Difference (%)|18.3|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71822428|NCT01052662|143147159|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.64|TWO_SIDED||||||Log Rank|||||||0.64
71761787|NCT02930018|143025334|SUPERIORITY||Odds Ratio (OR)|0.572||||0.055|TWO_SIDED|95.0|0.323|1.013|||Regression, Logistic|||||1.013|0.323|0.055
71761788|NCT02930018|143025334|SUPERIORITY||Absolute Risk Difference (%)|7.5|||||TWO_SIDED||||||||The unadjusted absolute risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71761789|NCT02930018|143025334|SUPERIORITY||Relative Risk Difference (%)|39.7|||||TWO_SIDED||||||||The unadjusted relative risk difference in % between nerinetide and placebo in the no-alteplase subgroup.|||||
71761790|NCT02930018|143025335|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.887||||0.529|TWO_SIDED|95.0|0.612|1.286|||Regression, Logistic|||||1.286|0.612|0.529
71761791|NCT02930018|143025336|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|0.782||||0.181|TWO_SIDED|95.0|0.545|1.121|||Regression, Logistic|||||1.121|0.545|0.181
71700350|NCT01013753|142916417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.164|0.25|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.250|0.164|<0.0001
71761792|NCT02930018|143025337|SUPERIORITY|It is hypothesized that the cleavage of nerinetide by plasmin which is activated by tissue plasminogen activators, such as alteplase results in a treatment modification of nerinetide in AIS patients with prior administration of alteplase as part of standard-of-care.|Odds Ratio (OR)|1.05||||0.869|TWO_SIDED|95.0|0.588|1.874|||Regression, Logistic|||||1.874|0.588|0.869
71761793|NCT02685267|143025339|OTHER|The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.|log-rank test|0.6761||||0.6761|TWO_SIDED|95.0|||||Chi-squared|||The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.||||0.6761
71822429|NCT01052662|143147160|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4||||1.2|TWO_SIDED|||||These results are using survival curve estimates to first positive urine toxicology for any opioid. The last observation carried forward (LOCF) was used to perform our survival event analyses.|Log Rank|||||||1.2
71822430|NCT01818700|143147216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|-10.0|10.0|||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||10|-10|<0.05
71890332|NCT01986062|143302157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71890333|NCT01986062|143302158|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71822431|NCT01852955|143147222|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
71822432|NCT01852955|143147223|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.04
71822433|NCT01852955|143147224|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.36
71822434|NCT01272011|143147274|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Two-way RMANOVA Student-Newman-Keuls|||Daily acute and cumulative Pre vs Post comparisons||||<0.001
71822435|NCT01272011|143147275|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of AF vs. Resistance||||<0.05
71822436|NCT01272011|143147275|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of of Pressure vs. Resistance||||<0.05
71822437|NCT02013687|143147279|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
71822438|NCT02013687|143147279|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)|||||||<0.001
71822439|NCT02013687|143147280|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71822440|NCT02013687|143147280|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71700351|NCT01013753|142916417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.11|0.194|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.194|0.110|<0.0001
71700352|NCT01013753|142916418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.056|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.056|<0.0001
71700353|NCT01013753|142916418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.180|0.090|<0.0001
71700354|NCT01013753|142916418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.116|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.207|0.116|<0.0001
71700355|NCT01013753|142916418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.134|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.226|0.134|<0.0001
71822441|NCT02013687|143147281|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71822442|NCT02013687|143147281|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71822443|NCT01657032|143147288|NON_INFERIORITY_OR_EQUIVALENCE|The differences between the study groups were considered significant when the P value was \<0.05.||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71822444|NCT03633903|143147299|SUPERIORITY||Mean Difference (Final Values)|1.04|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This applies to the change from row 1 to row 3 (e.g., baseline pre TSST-C versus follow-up timepoint pre TSST-C)"|Mixed Models Analysis|||||||<.05
71822445|NCT03633903|143147299|SUPERIORITY||Mean Difference (Final Values)|0.77|||<|0.05|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~This is for the difference from row 1 to row 2 (baseline pre versus baseline post TSST-C)"|Mixed Models Analysis|||||||<.05
71822446|NCT03633903|143147299|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.4|TWO_SIDED|||||"The reported p-value was calculated and is not indicating a threshold for significance.~Comparing row 1 and row 4 (baseline pre TSST-C versus follow-up post TSST-C)."|Mixed Models Analysis|||||||0.40
71822447|NCT03633903|143147300|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.39|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (CRP biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.39
71822448|NCT03633903|143147300|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.95|TWO_SIDED||||||Mixed Models Analysis|||Comparing group differences (IL-6 biomarker) in mindfulness versus control at baseline versus follow-up timepoints.||||.95
71761794|NCT01027806|143025347|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71822449|NCT03633903|143147301|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.08|TWO_SIDED|||||the calculated p value.|Mixed Models Analysis|||Comparing group differences (symptoms of anxiety/depression) in mindfulness versus control at baseline versus follow-up timepoints.||||.08
71822450|NCT02300311|143147341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.849|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|-2.454|-1.244||The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo).|"PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours."||-1.244|-2.454|<0.0001
71822451|NCT02300311|143147342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.341|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|-1.832|-0.851||The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream - placebo)|"PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours."||-0.851|-1.832|<0.0001
71890334|NCT01986062|143302159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71890335|NCT01986062|143302160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71822452|NCT02300311|143147343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.958|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.712|-2.205|||ANCOVA|ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.|Differences between the treatment group effects (Finalgon® cream - placebo)|The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.||-2.205|-3.712|<0.0001
71822453|NCT02300311|143147344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.0001|TWO_SIDED|95.0|5.342|24.199|||Regression, Logistic|Ordinal logistic regression models adjusting for the continuous covariate 'baseline PI' and the categorical variable 'country' was performed.|Odds ratio of (Finalgon® cream / placebo)|"For the analysis of the repeated multinomial efficacy endpoint 'patient assessment of efficacy' on the last individual treatment day, ordinal logistic regression models is used.~Only non-missing data is analysed in the statistical model."||24.199|5.342|<0.0001
71822454|NCT01656759|143147359|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||||||0.2
71822455|NCT01656759|143147360|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
71822456|NCT01656759|143147362|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
71822457|NCT02531438|143147363|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-1.6|||||TWO_SIDED|95.0|-7.1|3.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||3.8|-7.1|
71822458|NCT02531438|143147364|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-2.4|7.4|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||7.4|-2.4|
71700356|NCT01013753|142916418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.12|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.211|0.120|<0.0001
71822459|NCT02531438|143147365|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-1.7|6.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.|||6.8|-1.7|
71822460|NCT00811187|143147396|SUPERIORITY|\[Not Specified\]|Mean Difference (Net)|-2.03|||<|0.001|TWO_SIDED||||||Regression, Linear||Treatment pain difference= Lidocaine (0.97) - Placebo (3.00).|A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.||||<.001
71822461|NCT00994279|143147489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Chi-squared|||Null hypothesis is that the two arms will not differ in retention at 14 weeks.||||.53
71883298|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.6|||||TWO_SIDED|95.0|0.37|0.88|||||Confidence intervals for the ratio are back transformation of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.88|0.37|
71700357|NCT01013753|142916419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.148|0.058|<0.0001
71700358|NCT01013753|142916419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.088|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.177|0.088|<0.0001
71822462|NCT00994279|143147490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.||||.98
71883299|NCT00562354|143286225|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|0.5|||||TWO_SIDED|95.0|0.3|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.79|0.30|
71883300|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-4.9|||||TWO_SIDED|95.0|-12.1|2.0||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.0|-12.1|
71883301|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.6|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-11.6|
71883302|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.6|2.2||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.2|-9.6|
71883303|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-13.7|2.5||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-13.7|
71883304|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.7|2.1||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.7|
71883305|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-1.6|||||TWO_SIDED|95.0|-5.9|2.1||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-5.9|
71883306|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.8|-0.9||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.9|-10.8|
71883307|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-8.7|6.9||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-8.7|
71883308|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.1|-4.0|
71883309|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.6|2.5||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.5|-7.6|
71883310|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-2.8|4.7||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.7|-2.8|
71883311|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.7||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.7|-8.8|
71761795|NCT00943072|143025372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|44.8|||<|0.0001|TWO_SIDED|95.0|33.0|56.6||P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA \> 20/200 and BCVA ≤ 20/200)|Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||56.6|33.0|< 0.0001
71761796|NCT00943072|143025373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|17.36|26.04|||ANCOVA||RD is the IAI group minus sham group. 95% confidence interval is for the RD.|||26.04|17.36|< 0.0001
71883312|NCT00562354|143286228|SUPERIORITY_OR_OTHER||difference in proportions|-6.2|||||TWO_SIDED|95.0|-14.1|1.5||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-14.1|
71761797|NCT00943072|143025373|SUPERIORITY_OR_OTHER||Least Square Mean|16.36|||||||||||ANCOVA||LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
71761798|NCT00943072|143025374|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-311.9|||<|0.0001|TWO_SIDED|95.0|-389.4|-234.4|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-234.4|-389.4|< 0.0001
71761799|NCT00943072|143025374|SUPERIORITY_OR_OTHER||Least Square Mean|-487.1|||||||||||ANCOVA||The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
71883313|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-7.2|||||TWO_SIDED|95.0|-15.1|0.3||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.3|-15.1|
71883314|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-5.4|||||TWO_SIDED|95.0|-14.5|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.5|-14.5|
71883315|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-11.2|||||TWO_SIDED|95.0|-21.4|-1.0||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.0|-21.4|
71883316|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-4.7|||||TWO_SIDED|95.0|-13.5|3.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.9|-13.5|
71883317|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-5.1|||||TWO_SIDED|95.0|-14.3|4.0||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.0|-14.3|
71883318|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-12.9|||||TWO_SIDED|95.0|-24.6|-0.8||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-0.8|-24.6|
71883319|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-7.3|||||TWO_SIDED|95.0|-16.3|1.5||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.5|-16.3|
71883320|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-17.5|||||TWO_SIDED|95.0|-29.5|-5.0||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.0|-29.5|
71883321|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||||TWO_SIDED|95.0|-21.4|2.4||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.4|-21.4|
71890336|NCT01986062|143302161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71890337|NCT01986062|143302162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71761800|NCT00943072|143025375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.6||||0.0059|TWO_SIDED|95.0|-12.2|-1.1|||Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||-1.1|-12.2|0.0059
71761801|NCT00943072|143025376|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.26||||0.0009|TWO_SIDED|95.0|2.61|9.91|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.|||9.91|2.61|0.0009
71761802|NCT00943072|143025376|SUPERIORITY_OR_OTHER||Least Square Mean|8.8|||||||||||ANCOVA||Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.|||||
71761803|NCT00552188|143025377|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline value||||0.34
71761804|NCT00552188|143025378|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANCOVA|||ANCOVA model adjusted for baseline||||0.15
71761805|NCT01193257|143025388|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.12085|TWO_SIDED|95.0|0.739|1.036|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\[less than or equal to\] \<=4, greater than \[\>\] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||1.036|0.739|0.12085
71883322|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-10.5|||||TWO_SIDED|95.0|-19.3|-1.3||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.3|-19.3|
71883323|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|0.8|||||TWO_SIDED|95.0|-6.2|7.9||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.9|-6.2|
71700359|NCT01013753|142916419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.124|0.214|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.214|0.124|<0.0001
71822463|NCT01606189|143147491|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.58||||0.005|TWO_SIDED|95.0|-0.98|-0.18|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.18|-0.98|0.005
71822464|NCT01606189|143147491|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.002|TWO_SIDED|95.0|-1.03|-0.24|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period||-0.24|-1.03|0.002
71822465|NCT01606189|143147492|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.2||||0.017|TWO_SIDED|95.0|-0.37|-0.04|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.04|-0.37|0.017
71822466|NCT01606189|143147492|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period||-0.16|-0.49|<0.001
71883324|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-3.8|||||TWO_SIDED|95.0|-12.2|4.5||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||4.5|-12.2|
71883325|NCT00562354|143286231|SUPERIORITY_OR_OTHER||difference in proportions|-2.5|||||TWO_SIDED|95.0|-12.5|7.3||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||7.3|-12.5|
71700360|NCT01013753|142916419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.153|0.244|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.244|0.153|<0.0001
71822467|NCT01606189|143147493|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.55||||0.019|TWO_SIDED|95.0|0.09|1.01|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.01|0.09|0.019
71822468|NCT01606189|143147493|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.79||||0.001|TWO_SIDED|95.0|0.33|1.24|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period||1.24|0.33|0.001
71883326|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-5.7|||||TWO_SIDED|95.0|-13.8|2.1||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||2.1|-13.8|
71883327|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-5.5|||||TWO_SIDED|95.0|-15.9|5.0||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||5.0|-15.9|
71822469|NCT01606189|143147494|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.55||||0.146|TWO_SIDED|95.0|-3.64|0.55|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||0.55|-3.64|0.146
71822470|NCT01606189|143147494|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.2||||0.04|TWO_SIDED|95.0|-4.29|-0.1|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period||-0.10|-4.29|0.040
71822471|NCT01606189|143147495|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.28||||0.092|TWO_SIDED|95.0|-15.78|1.21|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||1.21|-15.78|0.092
71822472|NCT01606189|143147495|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.99||||0.037|TWO_SIDED|95.0|-17.41|-0.57|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period||-0.57|-17.41|0.037
71822473|NCT01606189|143147496|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1222.0||||0.328||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.328
71822474|NCT01606189|143147496|SUPERIORITY_OR_OTHER_LEGACY||Mann-Whitney U statistic|1200.5||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.||||0.560
71822475|NCT01606189|143147497|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.75||||0.181|TWO_SIDED|95.0|-4.32|0.83|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||0.83|-4.32|0.181
71822476|NCT01606189|143147497|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.43||||0.739|TWO_SIDED|95.0|-2.12|2.98|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period||2.98|-2.12|0.739
71822477|NCT01606189|143147498|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.23||||0.015|TWO_SIDED|95.0|-4.01|-0.45|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||-0.45|-4.01|0.015
71822478|NCT01606189|143147498|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.21||||0.178|TWO_SIDED|95.0|-2.97|0.56|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period||0.56|-2.97|0.178
71822479|NCT00162942|143147500|SUPERIORITY_OR_OTHER|||||||0.858|||||||Fisher Exact|||||||.858
71822480|NCT00162942|143147502|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Student's t-test|||||||0.813
71822481|NCT00162942|143147503|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
71822482|NCT00162942|143147504|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Student's t-test|||||||0.670
71883328|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-18.3|||||TWO_SIDED|95.0|-30.1|-5.9||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-5.9|-30.1|
71890338|NCT04596891|143302179|OTHER|Repeated measures ANOVA|F ratio|20.62|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio.|No control group, open trial for feasibility/safety||||<0.001
71700361|NCT01013753|142916419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.058|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.147|0.058|<0.0001
71822483|NCT00162942|143147505|SUPERIORITY_OR_OTHER|||||||0.977||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.977
71822484|NCT00162942|143147506|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.670
71822485|NCT00162942|143147507|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.170
71822486|NCT00162942|143147508|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0773
71822487|NCT00162942|143147509|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.261
71822488|NCT00162942|143147510|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.379
71822489|NCT00162942|143147511|SUPERIORITY_OR_OTHER|||||||0.441||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.441
71822490|NCT00162942|143147512|SUPERIORITY_OR_OTHER|||||||0.759||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.759
71822491|NCT00162942|143147513|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.222
71822492|NCT00162942|143147514|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.256
71822493|NCT00162942|143147515|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.870
71822494|NCT00162942|143147516|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.350
71822495|NCT00162942|143147517|SUPERIORITY_OR_OTHER|||||||0.0632||95.0|||||Fisher Exact|||||||0.0632
71822496|NCT00162942|143147517|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0504
71822497|NCT00162942|143147518|SUPERIORITY_OR_OTHER|||||||0.8265||95.0|||||Fisher Exact|||||||0.8265
71883329|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-2.3|||||TWO_SIDED|95.0|-11.6|6.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.9|-11.6|
71883330|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.6|-1.2||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-22.6|
71883331|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-11.0|||||TWO_SIDED|95.0|-23.8|1.9||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||1.9|-23.8|
71883332|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-9.5|||||TWO_SIDED|95.0|-19.3|0.4||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||0.4|-19.3|
71883333|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-26.9|||||TWO_SIDED|95.0|-39.0|-14.1||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-14.1|-39.0|
71883334|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-6.4|||||TWO_SIDED|95.0|-18.7|6.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||6.1|-18.7|
71822498|NCT00162942|143147519|SUPERIORITY_OR_OTHER|||||||0.0676||95.0|||||Fisher Exact|||||||0.0676
71822499|NCT00162942|143147519|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact (Mid-P-Value)|||||||0.0506
71822500|NCT00162942|143147520|SUPERIORITY_OR_OTHER|||||||0.8721||95.0|||||Fisher Exact|||||||0.8721
71883335|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-12.2|||||TWO_SIDED|95.0|-22.6|-1.7||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.7|-22.6|
71822501|NCT00162942|143147521|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||Fisher Exact|||||||0.0289
71883336|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||8.1|-9.8|
71883337|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||||TWO_SIDED|95.0|-21.7|-1.2||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||-1.2|-21.7|
71822502|NCT00162942|143147522|SUPERIORITY_OR_OTHER|||||||0.8618||95.0|||||Fisher Exact|||||||0.8618
71822503|NCT00410384|143147527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0167|TWO_SIDED|95.0|1.08|2.19||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.19|1.08|0.0167
71822504|NCT00410384|143147527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)|Regression, Logistic|Adjusted for baseline stratification factors.||||1.94|0.95|0.0889
71822505|NCT00410384|143147528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.1323|TWO_SIDED|95.0|0.92|1.87|||Regression, Logistic|Analysis was adjusted for baseline stratification factors.||||1.87|0.92|0.1323
71822506|NCT00410384|143147528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.105|TWO_SIDED|95.0|0.94|1.91|||Regression, Logistic||Analysis was adjusted for baseline stratification factors.|||1.91|0.94|0.1050
71822507|NCT00410384|143147529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0063|TWO_SIDED|95.0|1.15|2.32|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.32|1.15|0.0063
71822508|NCT00410384|143147529|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.074|TWO_SIDED|95.0|0.97|1.96|||Regression, Logistic|Adjusted for baseline stratification factors.||||1.96|0.97|0.0740
71822509|NCT00410384|143147530|SUPERIORITY_OR_OTHER|||||||0.7962|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.7962
71822510|NCT00410384|143147530|SUPERIORITY_OR_OTHER|||||||0.9703|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.||||||0.9703
71822511|NCT00410384|143147531|SUPERIORITY_OR_OTHER|||||||0.6583|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.6583
71883338|NCT00562354|143286234|SUPERIORITY_OR_OTHER||difference in proportions|-7.7|||||TWO_SIDED|95.0|-18.5|3.4||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).||3.4|-18.5|
71890339|NCT04596891|143302179|OTHER|Paired-samples t-test (baseline to post-treatment)|paired-samples t-test|5.2||||0.002|TWO_SIDED|95.0|-1.79|12.93|||t-test, 2 sided|||||12.93|-1.79|0.002
71890340|NCT04596891|143302184|OTHER|ANOVA|F ratio|8.46|||<|0.001|TWO_SIDED|95.0|||||ANOVA||The F ratio is used to evaluate the main effect of time in the ANOVA in relation to the critical F ratio. If it exceeds the critical F ratio, the null hypothesis (no effect of time) is rejected.|||||<0.001
71883339|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.6|||||TWO_SIDED|95.0|0.43|0.86|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.86|0.43|
71883340|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.8|||||TWO_SIDED|95.0|0.63|1.0|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.00|0.63|
71883341|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.66|||||TWO_SIDED|95.0|0.48|0.91|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.91|0.48|
71822512|NCT00410384|143147531|SUPERIORITY_OR_OTHER|||||||0.3762|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.||||||0.3762
71822513|NCT00410384|143147532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.4253|TWO_SIDED|95.0|0.65|2.74|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||2.74|0.65|0.4253
71822514|NCT00410384|143147532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2081|TWO_SIDED|95.0|0.78|3.13|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.||||3.13|0.78|0.2081
71822515|NCT01167023|143147536|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.26||||0.304||95.0||||Pain rate was analyzed using an analysis of covariance (ANCOVA) model, with baseline pain intensity, treatment group, and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.304
71822516|NCT01167023|143147538|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.051|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time\*treatment interaction as fixed effects, and participant as a random effect in the model was used.|Mixed Models Analysis||Least Squares Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
71822517|NCT01167023|143147539|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.244||95.0||||Average pain intensity was analyzed using an analysis of covariance (ANCOVA) model, with baseline intensity, treatment group and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||0.244
71883342|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.5|0.85|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.85|0.50|
71883343|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.71|||||TWO_SIDED|95.0|0.52|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.52|
71822518|NCT01167023|143147540|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-128.3|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time and time\*treatment interaction as fixed effects, and participant as a random effect in the model.|Mixed Models Analysis||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.|||||<0.001
71822519|NCT01253200|143147543|NON_INFERIORITY_OR_EQUIVALENCE|The Primary Safety Endpoint was evaluated using a one-sided, non-inferiority test for two binomial proportions at an alpha-level of 0.05. A 95% confidence interval based upon a score test of the difference of proportion of subjects in the Investigational and Control Groups free from a procedure-related complication seven days post-procedure was constructed. The upper bound of the confidence interval was compared to 10%.|Risk Difference (RD)|4.6|||||ONE_SIDED|95.0||9.78||||||Note that analysis of the primary outcome was conducted for Randomized subjects only as prespecified in the study protocol. This is consistent analysis publicly available in the Summary of Safety and Effectiveness Data (SSED).||9.78||
71822520|NCT02049437|143147547|SUPERIORITY||Risk Ratio (RR)|4.43||||0.07|TWO_SIDED|95.0|0.9|21.83|||Mixed Models Analysis|||||21.83|0.90|0.07
71822521|NCT02049437|143147548|SUPERIORITY||Mean Difference (Final Values)|-2036.8|||<|0.001|TWO_SIDED|95.0|-3490.32|-900.62|||Wilcoxon (Mann-Whitney)|||||-900.62|-3490.32|<0.001
71822522|NCT02049437|143147549|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.77|TWO_SIDED|95.0|-0.79|0.65|||Wilcoxon (Mann-Whitney)|||||0.65|-0.79|0.77
71822523|NCT05567952|143147550|SUPERIORITY||Least square (LS) mean difference|-0.705|||=|0.0004|TWO_SIDED|95.0|-1.093|-0.316|||MMRM|||Mixed model for repeated measures (MMRM) included fixed effects of treatment, geographic region, baseline SARS-CoV-2 RNA level, visit, and treatment-by-visit interaction; an unstructured (co) variance structure was used.||-0.316|-1.093|= 0.0004
71883344|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.65|||||TWO_SIDED|95.0|0.48|0.9|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.90|0.48|
71822524|NCT05567952|143147551|SUPERIORITY||Hazard Ratio (HR)|1.235|||=|0.0697|TWO_SIDED|95.0|0.983|1.551|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (less than or equal to \[\<=6\] months, \> 6 months or unvaccinated) as appropriate.||1.551|0.983|= 0.0697
71822525|NCT05567952|143147552|SUPERIORITY||Hazard Ratio (HR)|1.084|||=|0.5202|TWO_SIDED|95.0|0.848|1.385|||COX proportional hazard ratio|||Analysis was based on Cox proportional hazard (PH) model which included treatment, geographic region, baseline SARS-CoV-2 RNA level (\< 4 log10 copies/mL or \>= 4 log10 copies/mL) and time since the last vaccination (\<=6 months, \> 6 months or unvaccinated) as appropriate.||1.385|0.848|= 0.5202
71883345|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.74|||||TWO_SIDED|95.0|0.56|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.97|0.56|
71883346|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.46|||||TWO_SIDED|95.0|0.35|0.61|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.61|0.35|
71883347|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.76|||||TWO_SIDED|95.0|0.56|1.03|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||1.03|0.56|
71883348|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.57|||||TWO_SIDED|95.0|0.43|0.74|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.74|0.43|
71883349|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.5|||||TWO_SIDED|95.0|0.38|0.66|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.66|0.38|
71883350|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.42|||||TWO_SIDED|95.0|0.29|0.6|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.60|0.29|
71883351|NCT00562354|143286237|SUPERIORITY_OR_OTHER||ratio of geometric mean concentration|0.59|||||TWO_SIDED|95.0|0.42|0.82|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.||0.82|0.42|
71883352|NCT01508702|143286262|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.37|||Cochran-Mantel-Haenszel|||||0.37|0.19|<0.0001
71883353|NCT01883635|143286263|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.14
71883354|NCT01883635|143286264|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.65
71700362|NCT01013753|142916420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.052|0.154|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.154|0.052|<0.0001
71883355|NCT01883635|143286265|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|degrees of freedom=40||||||0.51
71883356|NCT01187953|143286266|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
71883357|NCT01187953|143286266|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.821|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.821
71883358|NCT01187953|143286266|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.9|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.900
71943913|NCT00840632|143409985|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.35||||||90.0|92.08|109.36|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.36|92.08|
71700363|NCT01013753|142916420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.106|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.106|<0.0001
71883359|NCT01187953|143286266|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||>0.999
71883360|NCT01187953|143286267|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.835|TWO_SIDED|||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.835
71883361|NCT01187953|143286267|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.548|TWO_SIDED|||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.548
71883362|NCT01187953|143286267|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.822|TWO_SIDED|||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.822
71883363|NCT01187953|143286267|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.383|TWO_SIDED|||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.||||0.383
71883364|NCT01464307|143286268|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.777|TWO_SIDED|95.0|-0.1|0.2|||Mixed-Model Repeated Measures|||The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.||0.2|-0.1|0.777
71883365|NCT01464307|143286269|SUPERIORITY_OR_OTHER|||||||0.804||||||worst-case analysis.|Wilcoxon's Rank-Sum Test|||The statistical analysis provided was for all categories of this outcome measure.||||0.804
71883366|NCT01464307|143286270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.845|TWO_SIDED|95.0|0.63|1.74||observed cases analysis.|Regression, Logistic|||Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.||1.74|0.63|0.845
71883367|NCT01464307|143286270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.437|TWO_SIDED|95.0|0.73|2.04||observed cases analysis.|Regression, Logistic|||Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.||2.04|0.73|0.437
71883368|NCT01464307|143286270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.698|TWO_SIDED|95.0|0.59|2.21||observed cases analysis.|Regression, Logistic|||Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.||2.21|0.59|0.698
71883369|NCT00802204|143286301|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|describe.....||Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD||||<0.05
71883370|NCT00802204|143286301|OTHER||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to compare baseline and post-diet outcome measures||||<0.05
71883371|NCT02701387|143286309|SUPERIORITY_OR_OTHER||||||<|0.01||||||"A 2-factor (implant type x time interval) nonparametric analysis for longitudinal data (Brunner et al. 2002) was used to compare test and control implants across time (baseline + four intervals). The R package nparLD was used (Noguchi et al. 2012)."|nonparametric for longitudinal|||Comparison of ISQ over time. Due to the high number of intervals (T0-T8) relative to the number of observations, data were combined for analysis purposes into 5 comparable intervals as follows: Baseline (T0, unchanged); Tr1=Average of follow-up weeks T1 and T2, Tr2=Average of follow-up weeks T3 and T4; Tr3=Average of follow-up weeks T5 and T6; Tr4=Average of follow-up weeks T7 and T8||||<0.01
71883372|NCT02043548|143286310|SUPERIORITY|||||||0.86|||||||GEE|||||||0.86
71883373|NCT02043548|143286311|SUPERIORITY|||||||0.77|||||||Log Rank|||||||0.77
71883374|NCT02043548|143286312|SUPERIORITY|||||||0.4|||||||binomial test|||||||0.40
71883375|NCT02043548|143286313|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
71883376|NCT02043548|143286314|SUPERIORITY|||||||0.78|||||||GEE|||||||0.78
71883377|NCT02043548|143286314|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
71943914|NCT00840632|143409986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.17||||||90.0|92.71|106.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.08|92.71|
71883378|NCT03829657|143286330|SUPERIORITY||Odds Ratio (OR)|0.6||||0.196|TWO_SIDED|95.0|0.27|1.29|||Regression, Logistic|||||1.29|0.27|0.196
71883379|NCT02404103|143286346|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.||||||0.148|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.148
71883380|NCT02404103|143286346|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.74|||||||Mixed Models Analysis|||||||.740
71883381|NCT02404103|143286346|EQUIVALENCE|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.921|||||||Mixed Models Analysis|||||||.921
71883382|NCT02404103|143286347|EQUIVALENCE|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.||||||0.872|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.872
71822526|NCT00777803|143147554|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.|difference of response rates|0.7|||||TWO_SIDED|95.0|-3.2|7.1|||||Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)|Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).||7.1|-3.2|
71822527|NCT04213846|143147568|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.94||||0.34|TWO_SIDED|95.0|0.81|1.07|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.07|0.81|0.34
71822528|NCT04213846|143147568|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.09||||0.37|TWO_SIDED|95.0|0.91|1.3|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.30|0.91|0.37
71822529|NCT04213846|143147568|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.02||||0.8|TWO_SIDED|95.0|0.85|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.85|0.80
71883383|NCT02404103|143286347|EQUIVALENCE|secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.82|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.820
71883384|NCT02404103|143286347|EQUIVALENCE|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.582|||||||Mixed Models Analysis|||||||0.582
71883385|NCT02404103|143286348|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.782|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.782
71883386|NCT02404103|143286348|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.906|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.906
71883387|NCT02404103|143286348|EQUIVALENCE|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.102|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.102
71883388|NCT02404103|143286349|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.62|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.||||||.620
71883389|NCT02404103|143286349|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.543|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.543
71883390|NCT02404103|143286349|EQUIVALENCE|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.6|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||.6
71883391|NCT00328627|143286350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||For the primary analysis, the overall average HbA1c response of the Alogliptin/pioglitazone combination groups was compared with that of the pioglitazone alone groups at the 2-sided 0.05 significance level with no adjustment for multiple comparisons.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||The null hypothesis was that the doses of alogliptin do not have any additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone. The alternative hypothesis was that at least the higher dose of alogliptin would have an additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone.||-0.41|-0.67|<0.001
71822530|NCT04213846|143147569|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|1.02||||0.75|TWO_SIDED|95.0|0.88|1.2|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.88|0.75
71822531|NCT04213846|143147569|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|1.04||||0.72|TWO_SIDED|95.0|0.86|1.25|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.25|0.86|0.72
71822532|NCT04213846|143147569|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.91|TWO_SIDED|95.0|0.85|1.21|||Generalized linear mixed model|Models controlled for sex, age, college type and used a Poisson error distribution. Peak eBAC multiplied by 100 and rounded up to the nearest integer.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.21|0.85|0.91
71822533|NCT04213846|143147570|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||0.99|0.69|0.04
71822534|NCT04213846|143147570|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.98||||0.84|TWO_SIDED|95.0|0.77|1.23|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.23|0.77|0.84
71822535|NCT04213846|143147570|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|0.9||||0.34|TWO_SIDED|95.0|0.73|1.22|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.22|0.73|0.34
71822536|NCT04213846|143147571|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 1-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 1-Month Follow-Up.|Count/Rate Ratio|0.98||||0.78|TWO_SIDED|95.0|0.82|1.16|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 1-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.16|0.82|0.78
71883392|NCT00328627|143286350|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||<|0.001|TWO_SIDED|95.0|-0.66|-0.41|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.41|-0.66|<0.001
71883393|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.93|-0.48||As a supportive analysis, each of the individual combination treatment groups was compared with the component treatment groups receiving aloliptin alone and pioglitazone alone at the 2-sided 0.05 significance level with no multiplicity adjustment.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.93|<0.001
71883394|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.81|-0.38|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.38|-0.81|<0.001
71822537|NCT04213846|143147571|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 6-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 6-Month Follow-Up.|Count/Rate Ratio|0.9||||0.27|TWO_SIDED|95.0|0.75|1.08|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 6-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.75|0.27
71883395|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.15|-0.59|0.001
71883396|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.30|-0.74|<0.001
71883397|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.53|-0.98|<0.001
71883398|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
71822538|NCT04213846|143147571|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=408 with a Condition × 12-Month Follow-Up interaction. Assessment-only control was the reference category for Condition, and Baseline was the reference category for 12-Month Follow-Up.|Count/Rate Ratio|1.01||||0.95|TWO_SIDED|95.0|0.84|1.2|||Generalized linear mixed model|Models controlled for sex, age, and college type (2-year vs. 4-year) and used a Poisson error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.20|0.84|0.95
71822539|NCT04213846|143147572|SUPERIORITY|Generalized linear model was estimated using a sample of N=346.|Count/Rate Ratio|0.98||||0.69|TWO_SIDED|95.0|0.89|1.08|||Generalized linear mixed model|Model controlled for sex, age, and college type (2-year vs. 4-year) and used a negative binomial error distribution.||Changes from Baseline to 12-Month Follow-Up for intervention versus assessment-only control reported in this section.||1.08|0.89|0.69
71822540|NCT05160025|143147619|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent with correction (x3) indicated the following: self-competition \> feedback (p \< 0.001) other-competition \> feedback (p \< 0.001) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
71883399|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.27|-0.71|<0.001
71883400|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.25|-0.70|<0.001
71883401|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.13|-0.68|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.68|-1.13|<0.001
71883402|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.77|-0.33|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.33|-0.77|<0.001
71883403|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.48|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.48|-0.92|<0.001
71883404|NCT00328627|143286382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.83|-0.39|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||||-0.39|-0.83|<0.001
71883405|NCT01137773|143286508|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71883406|NCT01137773|143286509|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
71883407|NCT01789814|143286525|SUPERIORITY_OR_OTHER|||||||0.001||||||Prasugrel treatment when compared to Clopidogrel was associated with significant reduction in platelets aggregation for all plateles agonist (ADD, SFFFLRN, AYPGKF) at all measured time points.|t-test, 2 sided|||Each patient will have paired samples representing their baseline as well as an on-drug sample. The magnitude of platelet inhibition for each studied agonist will be performed utilizing mean maximal change from baseline in light transmission aggregometry. The paired samples will be analyzed using a two-tailed student's t-test. Statistical significance will be assumed to occur when p\<0.05.||||0.001
71822541|NCT05160025|143147622|SUPERIORITY|||||||0.111||||||"rmANOVA p = 0.111~post hoc paired t-tests not performed"|ANOVA|||||||0.111
71822542|NCT05160025|143147625|SUPERIORITY||||||<|0.001||||||"rmANOVA \< 0.001~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.003) other-competition \> feedback (p = 0.007) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||<0.001
71883408|NCT01289015|143286555|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
71883409|NCT00428974|143286557|SUPERIORITY|||||||0.031|||||||t-test, 1 sided|||12 weeks, 2mg CF101 vs. Placebo||||0.031
71883410|NCT00428974|143286558|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71883411|NCT01425203|143286578|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|29.2|||<|0.0001|TWO_SIDED|95.0|16.4|41.5||Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization.||41.5|16.4|<0.0001
71883412|NCT01425203|143286579|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|30.2|||<|0.0001|TWO_SIDED|95.0|17.3|42.5||Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors.||42.5|17.3|<0.0001
71883413|NCT01425203|143286580|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Percentages|45.6|||<|0.0001|TWO_SIDED|95.0|33.2|57.0|||Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen \& Nurminen method.|The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population.||57.0|33.2|<0.0001
71822543|NCT05160025|143147628|SUPERIORITY||||||>|0.05||||||"rmANOVA p \> 0.05 with a partial eta squared effect size = 0.073~post hoc paired t-tests not performed"|ANOVA|||||||> 0.05
71883414|NCT00983983|143286593|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||Change over time in the ALSFRS-R was analyzed using random-slopes models||||0.07
71822544|NCT05160025|143147633|SUPERIORITY|||||||0.004||||||"rmANOVA = 0.004~post hoc paired t-tests or nonparametric equivalent corrected (x3) indicated the following: self-competition \> feedback (p = 0.007) other-competition \> feedback (p = 0.002) self-competition = other-competition (p \> 0.05)"|ANOVA|||||||0.004
71822545|NCT05160025|143147641|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
71822546|NCT05160025|143147642|SUPERIORITY||||||>|0.05||||||ranking compared to expected value for each condition and the p-value was adjusted for 3 comparisons for each condition: self-competition (p \> 0.05) other-competition (p \> 0.05) feedback (p \> 0.05)|Chi-squared|||||||> 0.05
71822547|NCT05516342|143147647|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71822548|NCT05516342|143147648|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71822549|NCT05516342|143147649|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71822550|NCT05516342|143147650|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71822551|NCT05516342|143147651|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71822552|NCT05516342|143147652|SUPERIORITY|||||||0.89|||||||ANOVA|||||||0.89
71822553|NCT05516342|143147653|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
71883415|NCT00983983|143286595|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||||||0.06
71822554|NCT05516342|143147654|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
71822555|NCT05516342|143147655|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
71822556|NCT03850444|143147656|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.38|1.0|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.00|0.38|
71822557|NCT03850444|143147657|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.41|0.95|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.95|0.41|
71822558|NCT03850444|143147658|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||0.94|0.45|
71822559|NCT03850444|143147659|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.57|1.28|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||1.28|0.57|
71822560|NCT03850444|143147660|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.39|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.39|0.70|
71822561|NCT03850444|143147661|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.74|1.35|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||1.35|0.74|
71822562|NCT03850444|143147662|OTHER||Difference in Percentage (DP)|17.2|||||TWO_SIDED|95.0|1.8|31.6|||Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||31.6|1.8|
71822563|NCT03850444|143147663|OTHER||Difference in Percentage (DP)|11.3|||||TWO_SIDED|95.0|-1.4|23.7|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||23.7|-1.4|
71822564|NCT03850444|143147664|OTHER||Difference in Percentage (DP)|8.0|||||TWO_SIDED|95.0|-3.0|18.9|||||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).|||18.9|-3.0|
71822565|NCT02107274|143147690|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71822566|NCT02107274|143147690|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71822567|NCT02107274|143147691|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71822568|NCT02107274|143147691|SUPERIORITY_OR_OTHER||||||<|0.01||||||p valu of less than 0.05 was considered significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables"||||<0.01
71883416|NCT00983983|143286596|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Fisher Exact|||||||0.0005
71883417|NCT00983983|143286597|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
71883418|NCT00382993|143286604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.63|||<|0.001||95.0|2.76|11.49|||ANOVA|||||11.49|2.76|<0.001
71883419|NCT03016325|143286641|SUPERIORITY|Part I, clinically relevant hypotension - relative risk|Relative risk from placebo|2.45|||||TWO_SIDED|95.0|0.83|14.53||||||||14.53|0.83|
71883420|NCT03016325|143286641|SUPERIORITY|Part I, clinically relevant hypotension - relative difference|Relative difference from placebo|0.12|||||TWO_SIDED|95.0|-0.02|0.28||||||||0.28|-0.02|
71883421|NCT03016325|143286641|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
71883422|NCT03016325|143286641|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
71822569|NCT02107274|143147692|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71822570|NCT02107274|143147692|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71883423|NCT03016325|143286641|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
71883424|NCT03016325|143286641|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
71883425|NCT03016325|143286641|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
71883426|NCT03016325|143286641|SUPERIORITY|Part II (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
71883427|NCT03016325|143286641|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
71883428|NCT03016325|143286641|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
71883429|NCT03016325|143286641|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
71883430|NCT03016325|143286641|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
71883431|NCT03016325|143286641|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative risk|Relative risk from placebo|1.9|||||TWO_SIDED|95.0|1.04|3.59||||||||3.59|1.04|
71700364|NCT01013753|142916420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.091|0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.192|0.091|<0.0001
71700365|NCT01013753|142916420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.118|0.221|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.221|0.118|<0.0001
71822571|NCT02107274|143147693|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71883432|NCT03016325|143286641|SUPERIORITY|Part II (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.16|||||TWO_SIDED|95.0|0.01|0.31||||||||0.31|0.01|
71883433|NCT03016325|143286641|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
71883434|NCT03016325|143286641|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
71883435|NCT03016325|143286641|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
71883436|NCT03016325|143286641|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
71943915|NCT00840632|143409987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|102.93||||||90.0|99.8|106.15|||||Informational Purposes Only|||106.15|99.80|
71822572|NCT02107274|143147693|SUPERIORITY_OR_OTHER||||||<|0.01||||||p value of less than 0.05 was considered significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."||||<0.01
71883437|NCT03016325|143286641|SUPERIORITY|Part II-Japan (low dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
71883438|NCT03016325|143286641|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
71883439|NCT03016325|143286641|SUPERIORITY|Part II-Japan (high dose), clinically relevant hypotension - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
71883440|NCT03016325|143286641|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
71883441|NCT03016325|143286644|SUPERIORITY|Part I, symptoms of hypotension - relative risk|Relative risk from placebo|2.94|||||TWO_SIDED|95.0|0.31|75.47||||||||75.47|0.31|
71883442|NCT03016325|143286644|SUPERIORITY|Part I, symptoms of hypotension - relative difference|Relative difference from placebo|0.04|||||TWO_SIDED|95.0|-0.06|0.15||||||||0.15|-0.06|
71883443|NCT03016325|143286644|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative risk|Relative risk from placebo|2.0|||||TWO_SIDED|95.0|0.18|54.35||||||||54.35|0.18|
71883444|NCT03016325|143286644|SUPERIORITY|Part II (low dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.01|||||TWO_SIDED|95.0|-0.05|0.09||||||||0.09|-0.05|
71883445|NCT03016325|143286644|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative risk|Relative risk from placebo|5.92|||||TWO_SIDED|95.0|0.91|149.72||||||||149.72|0.91|
71883446|NCT03016325|143286644|SUPERIORITY|Part II (high dose), symptoms of hypotension - relative difference|Relative difference from placebo|0.07|||||TWO_SIDED|95.0|-0.01|0.16||||||||0.16|-0.01|
71883447|NCT03016325|143286645|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|3.27|||||TWO_SIDED|95.0|1.01|14.66||||||||14.66|1.01|
71883448|NCT03016325|143286645|SUPERIORITY|Part I, confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.14|||||TWO_SIDED|95.0|0.0|0.29||||||||0.29|0.00|
71883449|NCT03016325|143286645|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.15|||||TWO_SIDED|95.0|0.58|2.43||||||||2.43|0.58|
71883450|NCT03016325|143286645|SUPERIORITY|Part II (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.03|||||TWO_SIDED|95.0|-0.11|0.16||||||||0.16|-0.11|
71822573|NCT03251144|143147719|OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71822574|NCT05305040|143147721|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.5603|TWO_SIDED|95.0|-0.09|0.1||1-sided p-value|ANCOVA|||||0.10|-0.09|0.5603
71822575|NCT04365413|143147765|OTHER||Median Difference (Final Values)|0.069|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
71883451|NCT03016325|143286645|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative risk|Relative risk from placebo|1.59|||||TWO_SIDED|95.0|0.87|3.21||||||||3.21|0.87|
71822576|NCT04365413|143147766|OTHER||Median Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
71883452|NCT03016325|143286645|SUPERIORITY|Part II (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.11|||||TWO_SIDED|95.0|-0.04|0.25||||||||0.25|-0.04|
71822577|NCT00519779|143147768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033|STANDARD_ERROR_OF_MEAN|0.09||0.97|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|adjusted for baseline value, visit, gender, SAD||||0.18|-0.18|0.97
71822578|NCT00519779|143147769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED|95.0|-0.44|-0.011|||Mixed Models Analysis|||||-0.011|-0.44|0.04
71822579|NCT00519779|143147770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.039||0.06|TWO_SIDED|95.0|-0.15|0.002|||Mixed Models Analysis|||||0.002|-0.15|0.06
71822580|NCT00519779|143147771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.072||0.04|TWO_SIDED|95.0|-0.3|-0.009|||Mixed Models Analysis|||||-0.009|-0.30|0.04
71883453|NCT03016325|143286645|SUPERIORITY|Part II-Japan (low dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.33|||||TWO_SIDED|95.0|-0.17|0.78||||||||0.78|-0.17|
71822581|NCT00519779|143147772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.08|TWO_SIDED|95.0|-0.33|0.018|||Mixed Models Analysis|||||0.018|-0.33|0.08
71822582|NCT00519779|143147773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.14||0.93|TWO_SIDED|95.0|-0.26|0.29|||Mixed Models Analysis|||||0.29|-0.26|0.93
71822583|NCT00367237|143147803|SUPERIORITY_OR_OTHER||Difference in percentages of respondents|19.61||||0.021||95.0|3.27|35.95||Comparison of treatments (IFX + MTX versus MTX)|Chi-squared||Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)|||35.95|3.27|0.0210
71822584|NCT00367237|143147803|SUPERIORITY_OR_OTHER||Proportion of Responders|0.863||||||95.0||||||||||||
71822585|NCT00367237|143147803|SUPERIORITY_OR_OTHER||Proportion of Responders|0.667||||||95.0||||||||||||
71822586|NCT05677867|143147854|OTHER||Ratio of Adjusted Geometric Means|97.4|||||TWO_SIDED|90.0|92.92|102.08|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% Confidence Intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.08|92.92|
71822587|NCT05677867|143147855|OTHER||Ratio of Geometric Adjusted Means|97.36|||||TWO_SIDED|90.0|92.77|102.17|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||102.17|92.77|
71883454|NCT03016325|143286645|SUPERIORITY|Part II-Japan (high dose), confirmed SBP \< 90 mmHg - relative difference|Relative difference from placebo|0.5|||||TWO_SIDED|95.0|-0.04|0.88||||||||0.88|-0.04|
71883455|NCT00814775|143286673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.72|TWO_SIDED|95.0|0.55|2.37|||Regression, Cox||CTrach vs. Fastrach|||2.37|0.55|0.72
71883456|NCT00814775|143286674|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.45|TWO_SIDED|95.0|0.38|1.54|||Regression, Cox||CTrach vs. Fastrach|||1.54|0.38|0.45
71883457|NCT01902290|143286679|SUPERIORITY||Difference|-0.05||||0.5219|TWO_SIDED|95.0|-0.203|0.103|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.103|-0.203|0.5219
71883458|NCT01902290|143286680|SUPERIORITY||Rate Ratio|1.41||||0.102|TWO_SIDED|95.0|0.93|2.12|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.12|0.93|0.102
71883459|NCT01902290|143286681|SUPERIORITY||Difference|-0.038||||0.6632|TWO_SIDED|95.0|-0.21|0.134|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification factors, and baseline ACQ score.|Difference = Brodalumab - Placebo|||0.134|-0.210|0.6632
71883460|NCT01902290|143286682|SUPERIORITY||Rate Ratio|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24|||Generalized linear model|Generalized linear model under a negative binomial distribution assumption adjusting for stratification factors.|Rate ratio = Brodalumab : Placebo|||2.24|0.94|0.096
71883461|NCT01902290|143286683|SUPERIORITY||Difference|-0.046||||0.329|TWO_SIDED|95.0|-0.137|0.046|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline score.|Difference = Brodalumab - Placebo|||0.046|-0.137|0.3290
71883462|NCT01902290|143286684|SUPERIORITY||Difference|0.03||||0.4549||95.0|-0.049|0.109|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and FEV1.|Difference = Brodalumab - Placebo|||0.109|-0.049|0.4549
71883463|NCT01902290|143286685|SUPERIORITY||Difference|0.128||||0.6317||95.0|-0.396|0.653|||Mixed-effect model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline value.|Difference = Brodalumab - Placebo|||0.653|-0.396|0.6317
71883464|NCT01902290|143286686|SUPERIORITY||Hazard Ratio (HR)|1.277||||0.238|TWO_SIDED|95.0|0.843|1.936|||Log Rank|Log rank test stratified for baseline stratification factors.||||1.936|0.843|0.238
71761806|NCT01193257|143025389|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.00038|TWO_SIDED|95.0|0.653|0.885|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (\<=4, \>4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.||0.885|0.653|0.00038
71761807|NCT01193257|143025390|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||< 0.0001
71883465|NCT01902290|143286687|SUPERIORITY||Odds Ratio (OR)|1.25||||0.351||95.0|0.78|2.01|||Regression, Logistic|Logistic regression adjusted for stratification factors.||||2.01|0.78|0.351
71883466|NCT01902290|143286688|SUPERIORITY||Difference|-0.001||||0.987||95.0|-0.174|0.171|||Mixed-effects model|The model included fixed effects of treatment group, time, interaction of treatment group by time, stratification variables, and baseline AQLQ score.|Difference = Brodalumab - Placebo|||0.171|-0.174|0.9870
71883467|NCT01902290|143286689|SUPERIORITY||Difference|0.635||||0.9053|TWO_SIDED|95.0|-9.82|11.089|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and AM PEFR.|Difference = Brodalumab - Placebo|Analysis of morning peak flow||11.089|-9.820|0.9053
71883468|NCT01902290|143286689|SUPERIORITY||Difference|5.92||||0.2661|TWO_SIDED|95.0|-4.515|16.354|||Mixed-effects model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, pooled race group, height and PM PEFR.|Difference = Brodalumab - Placebo|Analysis of evening peak flow||16.354|-4.515|0.2661
71883469|NCT01902290|143286690|SUPERIORITY||Difference|-4.021||||0.0871|TWO_SIDED|95.0|-8.627|0.586|||Mixed-effect model|Model includes treatment, time, stratification factors, treatment by time and baseline value of age, gender, race group, height and PEFR variation.|Difference = Brodalumab - Placebo|||0.586|-8.627|0.0871
71883470|NCT01618214|143286727|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%.|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||||95.0|-0.19|0.14|||Regression, Linear|||FAS||0.14|-0.19|
71883471|NCT00652366|143286740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.2026|TWO_SIDED|95.0|0.88|1.8|||Log Rank|||||1.80|0.88|0.2026
71883472|NCT00652366|143286742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6298|TWO_SIDED|95.0|0.77|1.54|||Log Rank|||||1.54|0.77|0.6298
71883473|NCT00652366|143286743|SUPERIORITY_OR_OTHER||Difference in Response Rates|-6.1||||0.2543|TWO_SIDED|95.0|-17.2|5.0|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||5.0|-17.2|0.2543
71761808|NCT01193257|143025391|SUPERIORITY_OR_OTHER|||||||0.12778|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.||||0.12778
71883474|NCT00652366|143286743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.19|1.56||||||||1.56|0.19|
71883475|NCT00652366|143286745|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-15.52||||0.0603|TWO_SIDED|95.0|-32.4|1.3|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||1.3|-32.4|0.0603
71883476|NCT00652366|143286747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2678|TWO_SIDED|95.0|0.6|1.15|||Log Rank|||||1.15|0.60|0.2678
71883477|NCT00652366|143286747|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8449|TWO_SIDED|95.0|0.74|1.43|||Log Rank|||||1.43|0.74|0.8449
71883478|NCT00652366|143286749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0217|TWO_SIDED|95.0|0.51|0.95|||Log Rank|||||0.95|0.51|0.0217
71883479|NCT00652366|143286749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1596|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1596
71883480|NCT01890642|143286750|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.01
71883481|NCT01890642|143286751|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Kruskal-Wallis|||||||0.80
71943916|NCT00840632|143409988|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.24||||||90.0|98.11|102.43|||||Informational Purposes Only|||102.43|98.11|
71761809|NCT01621802|143025428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.98|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.98|-0.72|
71883482|NCT01890642|143286752|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Kruskal-Wallis|||||||0.004
71883483|NCT01890642|143286753|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Kruskal-Wallis|||||||0.0001
71883484|NCT01890642|143286754|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Kruskal-Wallis|||||||0.37
71883485|NCT00137111|143286765|SUPERIORITY_OR_OTHER_LEGACY||Binomial proportion|79.27|||||TWO_SIDED|95.0|75.69|82.85|||Binomial proportion|||Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.||82.85|75.69|
71883486|NCT00137111|143286766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||||||p-value from t-test after stratified for lineage and ploidy|t-test, 2 sided|||t-test stratified for lineage and ploidy||||.0062
71883487|NCT00137111|143286767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||p-value from t-test after adjusted for lineage and ploidy|t-test, 2 sided|||t-test adjusting for lineage and ploidy||||.15
71883488|NCT00137111|143286768|SUPERIORITY_OR_OTHER_LEGACY|||||||9.5e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.00000095
71761810|NCT01621802|143025428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.71|||||TWO_SIDED|97.5|0.02|2.97|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||2.97|0.02|
71761811|NCT01621802|143025429|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO Group minus pooled Com\_MMR\_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.72|1.97|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.97|-0.72|
71761812|NCT01621802|143025429|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
71774888|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.54|STANDARD_ERROR_OF_MEAN|2.18||0.4807|TWO_SIDED|95.0|-5.83|2.75|||ANCOVA|||Baseline awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.75|-5.83|0.4807
71883489|NCT00137111|143286769|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-07|||||||Wilcoxon (Mann-Whitney)|||||||0.0000007
71883490|NCT04703075|143286770|SUPERIORITY||Risk Difference (RD)|5.5||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
71883491|NCT02572752|143286776|SUPERIORITY_OR_OTHER||gMean Ratio|97.478|STANDARD_ERROR_OF_MEAN|11.57|<|0.0001|TWO_SIDED|90.0|94.545|100.502|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.502|94.545|<0.0001
71883492|NCT02572752|143286777|SUPERIORITY_OR_OTHER||gMean Ratio|97.004|STANDARD_ERROR_OF_MEAN|20.77|<|0.0001|TWO_SIDED|90.0|90.948|103.463|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed.||103.463|90.948|<0.0001
71883493|NCT02572752|143286778|SUPERIORITY_OR_OTHER||gMean Ratio|97.149|STANDARD_DEVIATION|11.4|<|0.0001|TWO_SIDED|90.0|94.223|100.166|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 \& R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed||100.166|94.223|<0.0001
71883494|NCT02425826|143286779|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-39.84|||<|0.0001|TWO_SIDED|95.0|-54.39|-25.3|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-25.30|-54.39|<0.0001
71883495|NCT02425826|143286780|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5||||0.0008|TWO_SIDED|95.0|-3.9|-1.0|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||||-1.0|-3.9|0.0008
71883496|NCT02425826|143286781|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.0|||<|0.0001|TWO_SIDED|95.0|11.0|31.1||Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.|Cochran-Mantel-Haenszel||Two-sided 95% confidence intervals (CI) is based on normal approximation|||31.1|11.0|<0.0001
71883497|NCT02425826|143286782|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.7||||0.0365|TWO_SIDED|95.0|1.7|25.7|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||25.7|1.7|0.0365
71943917|NCT00840632|143409989|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.1||||||90.0|98.12|102.12|||||Informational Purposes Only|||102.12|98.12|
71883498|NCT02425826|143286783|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.6||||0.0016|TWO_SIDED|95.0|-18.8|-4.5|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||The treatment comparison was only done for Week 16; End of Phase||-4.5|-18.8|0.0016
71883499|NCT02425826|143286784|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.8||||0.0463|TWO_SIDED|95.0|-4.0|27.6|||Cochran-Mantel-Haenszel|p-value was based on 2-sided CMH tests stratified by sites.|Two-sided 95% CI is based on normal approximation.|||27.6|-4.0|0.0463
71883500|NCT02425826|143286785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.8|||<|0.0001|TWO_SIDED|95.0|10.36|25.24|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM-Effectiveness||25.24|10.36|<0.0001
71883501|NCT02425826|143286785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0||||0.3433|TWO_SIDED|95.0|-5.4|15.4|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM - Side Effects||15.40|-5.40|0.3433
71883502|NCT02425826|143286785|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.4||||0.625|TWO_SIDED|95.0|-4.25|7.06|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSMQ-Convenience||7.06|-4.25|0.6250
71761813|NCT01621802|143025430|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_CO group minus pooled Com\_MMR\_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|-0.14|||||TWO_SIDED|97.5|-0.98|1.84|||||Difference in percentage (Inv\_MMR\_CO Group minus Com\_MMR\_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."||1.84|-0.98|
71883503|NCT02425826|143286785|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.07|||<|0.0001|TWO_SIDED|95.0|7.16|20.97|||ANOVA|||TSQM-Global Satisfaction||20.97|7.16|<0.0001
71883504|NCT02425826|143286787|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-54.08|-19.91|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate||||-19.91|-54.08|<0.0001
71883505|NCT02425826|143286788|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.3|41.8|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation|||41.8|16.3|<0.0001
71883506|NCT02425826|143286789|SUPERIORITY_OR_OTHER_LEGACY||Difference|13.5||||0.0136|TWO_SIDED|95.0|4.4|22.7|||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test stratified by sites.|2-sided 95% CI is based on normal approximation.|||22.7|4.4|0.0136
71883507|NCT02997904|143286794|SUPERIORITY||Least Squares Mean Difference|1.0058|STANDARD_ERROR_OF_MEAN|0.2131|<|0.0001|TWO_SIDED|95.0|0.5829|1.4288|||ANOVA|||Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® \> Total Number of lice and eggs removed with sham control||1.4288|0.5829|<0.0001
71883508|NCT02997904|143286795|SUPERIORITY||Least Squares Mean Difference|1.2084|STANDARD_ERROR_OF_MEAN|0.0467|<|0.0001|TWO_SIDED|95.0|1.1157|1.3011||The P-Values were \<0.0001 in both comparison groups; total number lice removed and total number of eggs removed|GLIMMX|||Comparison of total number of lice removed and total number of eggs removed were analyzed separately||1.3011|1.1157|<0.0001
71774889|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.88|STANDARD_ERROR_OF_MEAN|2.07||0.6708|TWO_SIDED|95.0|-3.18|4.94|||ANCOVA|||Week 16 awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||4.94|-3.18|0.6708
71883509|NCT02997904|143286795|SUPERIORITY||Least Squares Mean Difference|0.7899|STANDARD_ERROR_OF_MEAN|0.04565|<|0.0001|TWO_SIDED|95.0|0.6993|0.8805|||GLIMMX|||||0.8805|0.6993|<0.0001
71883510|NCT00853671|143286800|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||||||<0.0001
71883511|NCT00853671|143286802|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson Correlation|||Pearson Correlation||||<0.0001
71883512|NCT00507559|143286815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.||||<0.001
71883513|NCT00631748|143286824|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|95.0|||||ANCOVA|We compared TLFB at baseline and at end of study.||We used a repeated-measures ANCOVA to compare cocaine usage between the two groups. This incorporated the multiple administrations of the Timeline Followback measure.||||<0.25
71883514|NCT00631748|143286825|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Cox|||End-of-trial abstinence was defined as a negative urine drug screen (for cocaine) for three consecutive weeks at the end of the study.||||.65
71883515|NCT00562588|143286848|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.067||||0.683||95.0|0.78|1.461|||Regression, Logistic|||The primary endpoint tele-mRS on day 90 was available in 527 of 543 treated patients (97.1%).||1.461|0.78|0.683
71883516|NCT00562588|143286849|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||ANCOVA|ANCOVA with factors for treatment, age, weight, baseline SBP, diabetes, previous stroke and baseline NIHSS||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||||0.607
71883517|NCT00562588|143286850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.202||95.0|0.442|1.189|||Cox proportional hazards model|||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono||1.189|0.442|0.202
71883518|NCT00150592|143286865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANCOVA|||||||0.844
71883519|NCT00150592|143286866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274||95.0|||||ANCOVA|Mean reaction time (adjusted) for each randomized treatment group at endpoint.||||||0.274
71883520|NCT00150592|143286868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||95.0|||||ANCOVA|||Between errors||||0.307
71883521|NCT00150592|143286868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0|||||ANCOVA|||Within errors||||0.552
71883522|NCT00150592|143286868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917||95.0|||||ANCOVA|||Double errors||||0.917
71883523|NCT00150592|143286868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||95.0|||||ANCOVA|||Strategy||||0.068
71883524|NCT00150592|143286869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
71883525|NCT00150592|143286870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
71883526|NCT00150592|143286871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||ANCOVA|||||||0.02
71883527|NCT00150592|143286872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANCOVA|||||||0.231
71883528|NCT02227693|143286873|OTHER||Difference of responder rate vs. placebo|19.5||||0.146|TWO_SIDED|95.0|-18.1|57.0|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||57.0|-18.1|0.146
71883529|NCT02227693|143286873|OTHER||Difference of responder rate vs. placebo|54.5||||0.004|TWO_SIDED|95.0|21.4|87.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||87.7|21.4|0.004
71883530|NCT02227693|143286873|OTHER||Difference of responder rate vs. placebo|30.9||||0.024|TWO_SIDED|95.0|-3.9|65.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.|||65.7|-3.9|0.024
71883531|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|14.3||||0.388|TWO_SIDED|95.0|-11.6|40.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||40.2|-11.6|0.388
71943918|NCT02262377|143410017|SUPERIORITY|The ITT analysis was done for 21 week average pain.|Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.92|1.15||Statistical significance was set at p\< 0.05.|Regression, Poisson|||Intention to Treat Analysis for average chronic pain.||1.15|0.92|0.68
71943919|NCT02262377|143410017|SUPERIORITY|The ITT analysis was done for 21 week BPI Interference.|Risk Ratio (RR)|0.98||||0.36|TWO_SIDED|95.0|0.88|1.08||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.08|0.88|0.36
71943920|NCT02262377|143410017|SUPERIORITY|The ITT analysis was done for 21 week BPI Severity.|Risk Ratio (RR)|1.0||||0.996|TWO_SIDED|95.0|0.86|1.16||Statistical significance was set at p\< 0.05.|Regression, Poisson|||||1.16|0.86|0.996
71774890|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7574|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Baseline quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.24|-0.32|0.7574
71883532|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|27.3||||0.214|TWO_SIDED|95.0|1.0|53.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)||53.6|1.0|0.214
71883533|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|62.3||||0.012|TWO_SIDED|95.0|24.8|99.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||99.9|24.8|0.012
71883534|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|72.7||||0.001|TWO_SIDED|95.0|44.3|100.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||100.0|44.3|0.001
71883535|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|40.9||||0.063|TWO_SIDED|95.0|5.6|76.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||76.2|5.6|0.063
71883536|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|-27.3||||0.245|TWO_SIDED|95.0|-53.6|-1.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||-1.0|-53.6|0.245
71883537|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|27.3||||0.386|TWO_SIDED|95.0|-12.2|66.8||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||66.8|-12.2|0.386
71883538|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|-7.3||||1|TWO_SIDED|95.0|-43.4|28.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.9|-43.4|1.000
71883539|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|-18.2||||0.496|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.496
71883540|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|-9.1||||1|TWO_SIDED|95.0|-37.5|19.3||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||19.3|-37.5|1.000
71943921|NCT02262377|143410018|SUPERIORITY||Risk Ratio (RR)|1.17||||0.054|TWO_SIDED|95.0|0.99|1.37|||Regression, Poisson|||||1.37|0.99|0.054
71883541|NCT02227693|143286874|OTHER||Difference of proportion vs. placebo|-18.2||||0.476|TWO_SIDED|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)||4.6|-41.0|0.476
71883542|NCT02227693|143286875|OTHER||Difference of proportion vs. placebo|63.6||||0.003|TWO_SIDED|95.0|35.2|92.1||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||92.1|35.2|0.003
71883543|NCT02227693|143286875|OTHER||Difference of proportion vs. placebo|30.0||||0.09|TWO_SIDED|95.0|1.6|58.4||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)||58.4|1.6|0.090
71883544|NCT02227693|143286875|OTHER||Difference of proportion vs. placebo|10.0||||0.476|TWO_SIDED|95.0|-8.6|28.6||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)||28.6|-8.6|0.476
71883545|NCT02227693|143286878|OTHER|||||||0.296||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.296
71883546|NCT02227693|143286878|OTHER|||||||0.07||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.070
71883547|NCT02227693|143286878|OTHER|||||||0.138||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)||||0.138
71883548|NCT02227693|143286878|OTHER|||||||0.012||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.012
71883549|NCT02227693|143286878|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
71883550|NCT02227693|143286878|OTHER|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)||||0.001
71883551|NCT02227693|143286878|OTHER|||||||0.624||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.624
71883552|NCT02227693|143286878|OTHER|||||||0.009||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.009
71761814|NCT01621802|143025430|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv\_MMR\_I group minus pooled Com\_MMR\_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||TWO_SIDED|97.5|-0.68|1.75|||||Difference in percentage (Inv\_MMR\_I Group minus Com\_MMR\_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."||1.75|-0.68|
71883553|NCT02227693|143286878|OTHER|||||||0.01||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)||||0.010
71883554|NCT02227693|143286878|OTHER|||||||0.154||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.154
71700366|NCT01013753|142916420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.051|0.153|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.153|0.051|<0.0001
71883555|NCT02227693|143286878|OTHER|||||||0.216||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.216
71883556|NCT02227693|143286878|OTHER|||||||0.901||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)||||0.901
71883557|NCT00874120|143286885|SUPERIORITY_OR_OTHER||residual error term from the ANOVA|-0.5||||0.548|TWO_SIDED|95.0|-2.0|1.1||P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.|ANOVA|||||1.1|-2.0|0.5480
71883558|NCT02164981|143286891|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.57|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE\_score = BASELINE\_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).||||0.57
71883559|NCT02164981|143286891|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.54|TWO_SIDED|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.||||0.54
71883560|NCT02164981|143286892|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.35|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparison.|ANCOVA|||||||0.35
71883561|NCT02164981|143286892|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.37|TWO_SIDED|||||Exploratory efficacy outcome, hence no adjustment for multiple comparisons|ANCOVA|||||||0.37
71883562|NCT02164981|143286893|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.85|TWO_SIDED||||||ANCOVA|||||||0.85
71883563|NCT02164981|143286893|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.88|TWO_SIDED||||||ANCOVA|||||||0.88
71883564|NCT02164981|143286894|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.86|TWO_SIDED||||||ANCOVA|||||||0.86
71883565|NCT02164981|143286894|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.83|TWO_SIDED||||||ANCOVA|||||||0.83
71883566|NCT02164981|143286900|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
71883567|NCT02164981|143286900|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
71883568|NCT02164981|143286903|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.34|TWO_SIDED||||||ANCOVA|||||||0.34
71883569|NCT02164981|143286903|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
71883570|NCT03548051|143286928|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
71883571|NCT03548051|143286931|SUPERIORITY||Difference in Proportions|0.05|||>|0.999|TWO_SIDED|95.0|-0.58|0.65||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in proportions between study arms, with a two-sided alternative.||0.65|-0.58|>0.999
71883572|NCT03548051|143286932|SUPERIORITY||||||>|0.999||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||A Log-Rank permutation test for small samples was used to test the null hypothesis that there is no difference in the time to first CDAD recurrence between treatment arms.||||>0.999
71883573|NCT02684981|143286965|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in PACT-Q2 scores from V1 to V2||||< 0.0001
71883574|NCT02684981|143286965|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3||||< 0.0001
71883575|NCT02684981|143286966|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2||||< 0.0001
71883576|NCT02684981|143286966|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3||||< 0.0001
71883577|NCT02684981|143286967|OTHER||Mean Difference (Net)|18.377|STANDARD_ERROR_OF_MEAN|0.514|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
71883578|NCT02684981|143286967|OTHER||Mean Difference (Net)|23.341|STANDARD_ERROR_OF_MEAN|0.509|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
71883579|NCT02684981|143286968|OTHER||Mean Difference (Net)|15.884|STANDARD_ERROR_OF_MEAN|0.388|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)||||< 0.001
71883580|NCT02684981|143286968|OTHER||Mean Difference (Net)|19.011|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)||||< 0.001
71883581|NCT02684981|143286976|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessment||||< 0.001
71883582|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.047||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.||||0.047
71883583|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.549||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.||||0.549
71883584|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.511||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.||||0.511
71943922|NCT02262377|143410019|SUPERIORITY||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.89|1.13|||Regression, Poisson|||||1.13|0.89|0.98
71883585|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.031||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.||||0.031
71761815|NCT01621802|143025431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.99|||||TWO_SIDED|97.5|0.92|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.92|
71761816|NCT01621802|143025431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.96|1.1|||ANCOVA|Ancova model: adjustment for baseline concentration country - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.10|0.96|
71761817|NCT01621802|143025432|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.0|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.00|0.83|
71883586|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.483||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.||||0.483
71883587|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.53||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.||||0.530
71883588|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.421||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.||||0.421
71883589|NCT01745146|143286979|EQUIVALENCE|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.332||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.||||0.332
71883590|NCT04623242|143286980|SUPERIORITY||Ratio|1.063|STANDARD_DEVIATION|0.059|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
71883591|NCT04623242|143286980|SUPERIORITY||Ratio|1.255|STANDARD_DEVIATION|0.061|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
71883592|NCT04623242|143286981|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.094||0.805|TWO_SIDED|95.0|-2.46|1.92|||t-test, 2 sided|||||1.92|-2.46|0.805
71761818|NCT01621802|143025432|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.96|||||TWO_SIDED|97.5|0.87|1.06|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.06|0.87|
71883593|NCT04623242|143286982|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.823||0.512|TWO_SIDED|95.0|-4.83|2.43|||t-test, 2 sided|||Test of equality (any treatment difference)||2.43|-4.83|0.512
71761819|NCT01621802|143025433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_CO group divided by pooled Com\_MMR\_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||TWO_SIDED|97.5|0.97|1.09|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|Adjusted geometric mean concentration (GMC) ratio (Inv\_MMR\_CO group divided by Com\_MMR\_CO group) for antibodies to rubella virus.||1.09|0.97|
71774891|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.2615|TWO_SIDED|95.0|-0.1|0.38|||ANCOVA|||Week 16 quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||0.38|-0.10|0.2615
71883594|NCT04623242|143286983|OTHER|Test of equality (any treatment difference)|Median Difference (Final Values)|-0.641|STANDARD_ERROR_OF_MEAN|0.1115|<|0.001|TWO_SIDED|95.0|-0.864|-0.417|||t-test, 2 sided|||||-0.417|-0.864|<0.001
71883595|NCT04623242|143286984|OTHER|Test of equality (any difference in the proportion of increase in the endpoint)|Ratio|0.3443||||0.5573|TWO_SIDED||||||Chi-squared|||||||0.5573
71883596|NCT04623242|143286985|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.092||0.707|TWO_SIDED|95.0|-1.77|2.6|||t-test, 2 sided|||||2.60|-1.77|0.707
71883597|NCT04623242|143286986|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.44||0.283|TWO_SIDED|95.0|-1.35|0.4|||t-test, 2 sided|||||0.40|-1.35|0.283
71883598|NCT04623242|143286987|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.859||0.674|TWO_SIDED|95.0|-1.34|2.07|||t-test, 2 sided|||||2.07|-1.34|0.674
71883599|NCT04623242|143286988|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.828||0.507|TWO_SIDED|95.0|-4.86|2.42|||t-test, 2 sided|||||2.42|-4.86|0.507
71883600|NCT04623242|143286989|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|1.706||0.553|TWO_SIDED|95.0|-4.41|2.38|||t-test, 2 sided|||||2.38|-4.41|0.553
71883601|NCT04623242|143286990|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.596||0.098|TWO_SIDED|95.0|-2.18|0.19|||t-test, 2 sided|||||0.19|-2.18|0.098
71883602|NCT04623242|143286991|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.98||0.173|TWO_SIDED|95.0|-1.22|6.68|||t-test, 2 sided|||||6.68|-1.22|0.173
71761820|NCT01621802|143025433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv\_MMR\_I group divided by pooled Com\_MMR\_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.95|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance.|The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|||1.07|0.95|
71883603|NCT04623242|143286992|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.998||0.94|TWO_SIDED|95.0|-8.1|8.71|||t-test, 2 sided|||||8.71|-8.10|0.940
71883604|NCT04623242|143286993|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|3.07|STANDARD_ERROR_OF_MEAN|16.524||0.854|TWO_SIDED|95.0|-30.49|36.62|||t-test, 2 sided|||||36.62|-30.49|0.854
71883605|NCT04623242|143286994|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|4.88|STANDARD_ERROR_OF_MEAN|17.448||0.781|TWO_SIDED|95.0|-30.0|39.75|||t-test, 2 sided|||||39.75|-30.00|0.781
71883606|NCT04623242|143286995|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|4.21||0.689|TWO_SIDED|95.0|-10.05|6.67|||t-test, 2 sided|||||6.67|-10.05|0.689
71883607|NCT04623242|143286996|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.689||0.474|TWO_SIDED|95.0|-1.86|0.87|||t-test, 2 sided|||||0.87|-1.86|0.474
71883608|NCT04623242|143286997|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.637||0.886|TWO_SIDED|95.0|-1.36|1.17|||t-test, 2 sided|||||1.17|-1.36|0.886
71883609|NCT04623242|143286998|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.556||0.873|TWO_SIDED|95.0|-1.03|1.2|||t-test, 2 sided|||||1.20|-1.03|0.873
71883610|NCT04623242|143286999|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.66||0.394|TWO_SIDED|95.0|-4.71|1.87|||t-test, 2 sided|||||1.87|-4.71|0.394
71883611|NCT04623242|143287000|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.063||0.776|TWO_SIDED|95.0|-2.41|1.81|||t-test, 2 sided|||||1.81|-2.41|0.776
71883612|NCT04623242|143287001|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.909||0.283|TWO_SIDED|95.0|-2.78|0.82|||t-test, 2 sided|||||0.82|-2.78|0.283
71883613|NCT04623242|143287002|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.947||0.634|TWO_SIDED|95.0|-2.33|1.42|||t-test, 2 sided|||||1.42|-2.33|0.634
71883614|NCT04623242|143287003|SUPERIORITY||Ratio|1.155|STANDARD_DEVIATION|0.074|||TWO_SIDED|||||A priori threshold for statistical significance||||||||
71883615|NCT04623242|143287004|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0562||0.726|TWO_SIDED|95.0|-0.093|0.132|||t-test, 2 sided|||||0.132|-0.093|0.726
71883616|NCT04623242|143287005|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.1056||0.439|TWO_SIDED|95.0|-0.13|0.295|||t-test, 2 sided|||||0.295|-0.130|0.439
71883617|NCT04623242|143287006|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.0168||0.967|TWO_SIDED|95.0|-0.034|0.033|||t-test, 2 sided|||||0.033|-0.034|0.967
71883618|NCT04623242|143287007|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0377||0.669|TWO_SIDED|95.0|-0.059|0.092|||t-test, 2 sided|||||0.092|-0.059|0.669
71883619|NCT04623242|143287008|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-34.46|STANDARD_ERROR_OF_MEAN|116.419||0.768|TWO_SIDED|95.0|-264.14|195.22|||t-test, 2 sided|||||195.22|-264.14|0.768
71883620|NCT04623242|143287010|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-2737.62|STANDARD_ERROR_OF_MEAN|6558.467||0.677|TWO_SIDED|95.0|-15678.06|10202.81|||t-test, 2 sided|||||10202.81|-15678.06|0.677
71883621|NCT04623242|143287011|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1078.32|STANDARD_ERROR_OF_MEAN|1788.474||0.547|TWO_SIDED|95.0|-4603.28|2446.64|||t-test, 2 sided|||||2446.64|-4603.28|0.547
71883622|NCT04623242|143287012|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-1935.91|STANDARD_ERROR_OF_MEAN|385.538|<|0.001|TWO_SIDED|95.0|-2717.64|-1154.18|||t-test, 2 sided|||||-1154.18|-2717.64|<0.001
71883623|NCT04623242|143287013|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-77.12|STANDARD_ERROR_OF_MEAN|23.014||0.003|TWO_SIDED|95.0|-124.56|-29.68|||t-test, 2 sided|||||-29.68|-124.56|0.003
71943923|NCT02262377|143410020|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.18|0.98|||Odds Ratio|||||0.98|0.18|
71883624|NCT04623242|143287014|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|30.89|STANDARD_ERROR_OF_MEAN|35.54||0.388|TWO_SIDED|95.0|-40.04|101.83|||t-test, 2 sided|||||101.83|-40.04|0.388
71883625|NCT04623242|143287015|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|6.624||0.909|TWO_SIDED|95.0|-13.97|12.45|||t-test, 2 sided|||||12.45|-13.97|0.909
71883626|NCT04623242|143287016|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.0593||0.004|TWO_SIDED|95.0|0.059|0.296|||t-test, 2 sided|||||0.296|0.059|0.004
71883627|NCT04623242|143287017|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.355||0.754|TWO_SIDED|95.0|-3.21|2.35|||t-test, 2 sided|||||2.35|-3.21|0.754
71883628|NCT04623242|143287019|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|229362.3|STANDARD_ERROR_OF_MEAN|14863.08|<|0.001|TWO_SIDED|95.0|199264.32|259460.27|||t-test, 2 sided|||||259460.27|199264.32|<0.001
71883629|NCT04623242|143287020|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|32906.6|STANDARD_ERROR_OF_MEAN|1697.541|<|0.001|TWO_SIDED|95.0|29406.49|36406.72|||t-test, 2 sided|||||36406.72|29406.49|<0.001
71883630|NCT04623242|143287021|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|1286.35|STANDARD_ERROR_OF_MEAN|140.692|<|0.001|TWO_SIDED|95.0|1002.79|1569.9|||t-test, 2 sided|||||1569.90|1002.79|<0.001
71883631|NCT04623242|143287022|OTHER|Test of equality (any treatment difference)|Mean Difference (Final Values)|9867.26|STANDARD_ERROR_OF_MEAN|1212.232|<|0.001|TWO_SIDED|95.0|7419.38|12315.15|||t-test, 2 sided|||||12315.15|7419.38|<0.001
71700367|NCT01013753|142916421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0107||95.0|0.014|0.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.107|0.014|0.0107
71700368|NCT01013753|142916421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.069|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.160|0.069|<0.0001
71761821|NCT04857320|143025454|SUPERIORITY|||||||1.6e-05|||||||ANOVA|Degrees of Freedom = 5||Glucose was monitored by means of a wearable Continuous Glucose Monitor for several days prior to, during and post dosing. Measurements were gathered for each subject and averaged within-subject data. Our null hypothesis was that post prandial serum glucose would not vary significantly from their baseline values.||||0.000016
71883632|NCT00179309|143287053|SUPERIORITY_OR_OTHER|||||||0.12|ONE_SIDED|95.0||||Multiple comparisons were not done.|Log Rank|||48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.||||0.12
71883633|NCT03716869|143287055|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.001|TWO_SIDED|95.0|1.39|3.1|||Regression, Logistic|||Statistical analysis was conducted using the intent-to-treat principle. Analysis for primary and secondary outcomes that compared universal to targeted screening was conducted using mixed effects logistic regression.||3.10|1.39|<0.001
71883634|NCT03716869|143287056|SUPERIORITY||Odds Ratio (OR)|5.92|||<|0.001|TWO_SIDED|95.0|5.07|6.93|||Regression, Logistic|||||6.93|5.07|<0.001
71700369|NCT01013753|142916421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.069|0.161|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.161|0.069|<0.0001
71883635|NCT03716869|143287058|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.49|4.38|||Regression, Logistic|||||4.38|2.49|<0.001
71883636|NCT03716869|143287064|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.001|TWO_SIDED|95.0|6.71|10.58|||Regression, Logistic||Test of interaction terms from mixed-effects logistic regression for subgroup analyses. Information above is sex x rand group interaction for identification of MDD symptoms among females. For males, OR 4.05 (95% CI 3.26-5.03).||"Sex x rand group interaction p=0.005 for SAP confirmation of need for follow-up.~Females 4.73 (3.19-7.02) Males 2.09 (1.38-3.16)~Sex x rand group interaction p=0.37 for treatment initiation. OR is not reported due to p\>0.05."|10.58|6.71|<0.001
71883637|NCT03716869|143287064|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|6.58|11.35|||Regression, Logistic||Information above is for race/ethnicity x rand group interaction for identification of MDD symptoms for non-Hispanic white students. For non-Hispanic Black students OR 2.55 (95% CI 1.97-3.31), Hispanic 7.45 (4.98-11.17), other 12.41 (7.34-21.00).||"Race/ethnicity x rand group p=0.007 for SAP confirmation of need for follow-up. non-Hispanic white 2.24 (1.59-3.15) non-Hispanic Black 4.19 (2.03-8.65) Hispanic 10.15 (4.06-25.36) Other 12.22 (1.59-94.12)~Race/ethnicity x rand group interaction p=0.15 for treatment initiation. OR is not reported due to p\>0.05."|11.35|6.58|<0.001
71883638|NCT03716869|143287064|SUPERIORITY||Odds Ratio (OR)|5.47||||0.006|TWO_SIDED|95.0|4.65|6.44|||Regression, Logistic||Information above is location x rand group interaction for identification of MDD symptoms among urban students. For rural students and identification of depressive symptoms OR 13.60 (95% CI 7.28-25.42).||"Location x rand group interaction p=0.27 for SAP confirmation of need for follow-up. OR is not reported due to p\>0.05.~Location x rand group interaction p=0.36 for treatment initiation. OR is not reported due to p\>0.05."|6.44|4.65|0.006
71761822|NCT04857320|143025455|SUPERIORITY|||||||0|||||||t-test, 1 sided|Degrees of Freedom = 3||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0
71883639|NCT01709149|143287068|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.366||0.114|TWO_SIDED|95.0|-1.3|0.14|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||0.14|-1.30|0.1140
71883640|NCT01709149|143287069|SUPERIORITY||Least squares mean difference|0.48|STANDARD_ERROR_OF_MEAN|1.963||0.8083|TWO_SIDED|95.0|-3.38|4.34|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||4.34|-3.38|0.8083
71943924|NCT02262377|143410021|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.9|1.14|||Odds Ratio|||||1.14|0.90|
71883641|NCT01709149|143287070|SUPERIORITY||Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.627||0.0372|TWO_SIDED|95.0|-6.6|-0.2|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||-0.20|-6.60|0.0372
71883642|NCT01709149|143287071|SUPERIORITY||Least squares mean difference|4.25|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.23|6.28|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||6.28|2.23|<0.0001
71943925|NCT00723528|143410025|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
71943926|NCT00723528|143410026|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sample t-test (using Holm's method)|t-test, 2 sided|||||||<0.0001
71943927|NCT00723528|143410036|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact|||||||<0.0001
71943928|NCT01993030|143410038|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Growth of Granulation Tissue between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with healthy granulation tissue and the Participants with unhealthy granulation tissue category."||||0.49
71943929|NCT01993030|143410039|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Inflammatory Reaction between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with Inflammatory Reaction and the Participants without Inflammatory Reaction category."||||0.36
71943930|NCT01993030|143410040|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the VAS score between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.11
71943931|NCT01993030|143410041|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Exudation between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to No exudation and Little exudation category."||||0.11
71943932|NCT01993030|143410042|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Values of p \< 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the Time to Wound Healing between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.||||0.02
71943933|NCT01710657|143410043|SUPERIORITY_OR_OTHER||% Reduction over Placebo|39.6|||<|0.001|TWO_SIDED|95.0|30.5|47.6||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||47.6|30.5|<0.001
71883643|NCT01709149|143287072|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.956||0.4328|TWO_SIDED|95.0|-1.13|2.63|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||2.63|-1.13|0.4328
71943934|NCT01710657|143410043|SUPERIORITY_OR_OTHER||% Reduction over Placebo|29.4|||<|0.001|TWO_SIDED|95.0|18.7|38.7||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."||38.7|18.7|< 0.001
71943935|NCT01591785|143410063|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
71943936|NCT01591785|143410064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Chi-squared|||||||0.28
71943937|NCT01591785|143410065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0495|TWO_SIDED||||||Chi-squared|||||||0.0495
71943938|NCT01591785|143410066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
71943939|NCT03979079|143410069|OTHER||Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.14|0.3||Estimation was performed using a Bayesian approach. As such, p-values are not estimated.|Two-stage model.||||Two-stage model within a Bayesian framework to assess the role of the prostate-specific antigens profile on clinical failure while accounting for a secondary treatment prescribed by indication. Prostatespecific antigens modeled using a hierarchical piecewise linear trajectory with a random changepoint. Residual prostate-specific antigens variability was expressed as a function of prostate-specific antigens concentration. Covariates in the survival model included hormone therapy, baseline characteristics, and individual predictions of the prostate-specific antigens nadir and timing and prostate-specific antigens slopes before and after the nadir as provided by the longitudinal process.|0.30|0.14|
71943940|NCT00909610|143410100|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.3|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||111|92.3|
71943941|NCT00909610|143410101|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|106.0||||||90.0|101.0|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|101|
71943942|NCT00909610|143410102|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|101.0||||||90.0|91.9|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|91.9|
71943943|NCT00909610|143410103|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|105.0||||||90.0|100.0|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|100|
71943944|NCT00909610|143410104|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.5|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.5|
71943945|NCT00909610|143410105|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117|103|
71700370|NCT01013753|142916421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.098|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.191|0.098|<0.0001
71700371|NCT01013753|142916421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.044|0.137|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.137|0.044|0.0001
71883644|NCT01709149|143287073|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|4.399||0.9546|TWO_SIDED|95.0|-8.4|8.9|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||8.90|-8.40|0.9546
71883645|NCT01709149|143287074|SUPERIORITY||Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|3.207||0.6166|TWO_SIDED|95.0|-4.7|7.91|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo|||7.91|-4.70|0.6166
71883646|NCT02797808|143287076|SUPERIORITY||||||<|0.0083||||||Independent-sample t tests were used to compare the RSFC metrics between groups at baseline and 12 weeks. Bonferroni correction was applied to the alpha level (2-tailed, p\<.05/6= .0083) for multiple testing.|ANOVA|||||||<0.0083
71700372|NCT01013753|142916422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.023||0.0005||95.0|0.036|0.128|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.128|0.036|0.0005
71883647|NCT00535132|143287080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|1.4|<|0.001||||||p-value based on a paired t-test for a within-group comparison.|t-test, 2 sided|||Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.||||<0.001
71883648|NCT00535132|143287081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71700373|NCT01013753|142916422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.09|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.181|0.090|<0.0001
71883649|NCT00535132|143287082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|1.4|<|0.001|||||||t-test, 2 sided|||||||<0.001
71883650|NCT00535132|143287083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71883651|NCT00535132|143287084|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.002
71883652|NCT00535132|143287085|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.033
71943946|NCT00909610|143410106|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
71943947|NCT00909610|143410107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
71943948|NCT01015625|143410127|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.77||||0.042|TWO_SIDED|95.0|1.01|3.09|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter overall survival time for surgery relative to no surgery.|To determine the effect of local therapy (surgery, Arm A) compared to systemic therapy only (Arm B) in synchronous metastasized breast cancer patients in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause. Participants last known to be alive were censored at their last contact date or at the data cut-off date whichever came first.||3.09|1.01|0.042
71943949|NCT01015625|143410128|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|1.45||||0.147|TWO_SIDED|95.0|0.87|2.42|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to distant progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to distant progression. Distant progression is defined as detection of new lesions or progression of existing metastases in locations different then breast. Participants last known to be alive without a distant progression were censored at their last contact date or at the data cut-off date whichever came first.||2.42|0.87|0.147
71883653|NCT00535132|143287086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_DEVIATION|13.1|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71883654|NCT00535132|143287087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|0.9|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71883655|NCT00535132|143287088|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|Fisher Exact|||||||0.123
71883656|NCT00535132|143287089|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.||||||0.125
71883657|NCT00535132|143287090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3|STANDARD_DEVIATION|23.1|<|0.001||||||p-value for within-group comparison based on a paired t-test.|t-test, 2 sided|||||||<0.001
71883658|NCT00535132|143287091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|7.5||0.009|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||0.009
71883659|NCT00535132|143287092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|10.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71883660|NCT00535132|143287093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|4.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71883661|NCT00535132|143287094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|3.0|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.||||||<0.001
71761823|NCT04857320|143025455|SUPERIORITY|||||||3e-06|||||||t-test, 1 sided|||Subject received doses applied to the skin of 0.075, 0.10 and 0.15 IUs / Kilogram on successive days. The Subject's average Serum Glucose for these 3 days were compared against the Subject's baseline unmedicated Serum Glucose on non-dosed days.||||0.000003
71883662|NCT01857713|143287100|NON_INFERIORITY_OR_EQUIVALENCE|It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|||||<|0.05|||||||t-test, 1 sided|||The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.||||<0.05
71700374|NCT01013753|142916422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.174|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.174|0.083|<0.0001
71883663|NCT05098041|143287106|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90 percent (%) confidence intervals (CIs) for the Geometric Mean Ratio (GMR) of Cmax for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the natural-log (ln)-transformed Cmax.|Geometric Mean Ratio (%)|13.15|||||TWO_SIDED|90.0|9.73|17.79|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||17.79|9.73|
71883664|NCT05098041|143287107|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUC∞ for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.|Geometric Mean Ratio (%)|16.42|||||TWO_SIDED|90.0|12.53|21.5|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||21.50|12.53|
71883665|NCT05098041|143287108|OTHER|Linear mixed-effects model was used for analysis. The model included treatment as a fixed effect and participant as a random effect. The point estimates and 90% CIs for the GMR of AUClast for Soticlestat and Rifampin versus Soticlestat alone were calculated using the exponentiation of the point estimates of the difference between treatment regimen and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.|Geometric Mean Ratio (%)|14.92|||||TWO_SIDED|90.0|11.94|18.64|||||GMR (%) was calculated as 100\*(Soticlestat + Rifampin/Soticlestat Alone).|||18.64|11.94|
71761824|NCT04857320|143025455|SUPERIORITY|||||||2e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000002
71883666|NCT05098041|143287109|OTHER||Median Difference (Final Values)|-0.117|||=|0.0791|TWO_SIDED|90.0|-0.202|0.0|||Wilcoxon Signed-Rank Test||Difference was calculated as (Soticlestat + Rifampin) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.000|-0.202|=0.07910
71883667|NCT03759665|143287111|SUPERIORITY||Hodges-Lehmann Estimator|0.75||||0.044|TWO_SIDED|90.0|0.0|1.5|||1-sided Wilcoxon signed-rank test|||||1.50|0.00|0.044
71883668|NCT03759665|143287113|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.206|TWO_SIDED|90.0|-0.13|0.25|||1-sided Wilcoxon signed-rank test|||||0.25|-0.13|0.206
71883669|NCT03759665|143287116|SUPERIORITY||Hodges-Lehmann Estimator|0.0327||||0.21|TWO_SIDED|90.0|-0.0327|0.104|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1040|-0.0327|0.210
71883670|NCT03759665|143287116|SUPERIORITY||Hodges-Lehmann Estimator|-0.0291||||0.212|TWO_SIDED|90.0|-0.0863|0.0262|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.0262|-0.0863|0.212
71883671|NCT03759665|143287117|SUPERIORITY||Hodges-Lehmann Estimator|-1.25|||<|0.001|TWO_SIDED|90.0|-1.75|-0.75|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.75|-1.75|<0.001
71761825|NCT04857320|143025455|SUPERIORITY|||||||3.5e-05|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000035
71761826|NCT04857320|143025455|SUPERIORITY|||||||4e-06|||||||t-test, 1 sided|Degrees of Freedom = 3||||||0.000004
71883672|NCT03759665|143287117|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.001|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.001
71883673|NCT03759665|143287119|SUPERIORITY||Hodges-Lehmann Estimator|-0.031||||0.02|TWO_SIDED|90.0|-0.063|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.063|0.020
71883674|NCT03759665|143287119|SUPERIORITY||Hodges-Lehmann Estimator|0.042|||<|0.001|TWO_SIDED|90.0|0.021|0.063|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.063|0.021|<0.001
71883675|NCT03759665|143287120|SUPERIORITY||Hodges-Lehmann Estimator|3.0|||<|0.001|TWO_SIDED|90.0|3.0|3.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||3.5|3.0|<0.001
71883676|NCT03759665|143287120|SUPERIORITY||Hodges-Lehmann Estimator|5.0|||<|0.001|TWO_SIDED|90.0|4.5|5.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||5.0|4.5|<0.001
71883677|NCT01857869|143287123|OTHER||1-Relative Risk|86.7|||<|0.0001|TWO_SIDED|95.0|66.8|94.6||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||94.6|66.8|<0.0001
71883678|NCT01857869|143287123|OTHER||1-Relative Risk|62.5||||0.0009|TWO_SIDED|95.0|29.4|80.1||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100\*(1-Relative Risk \[RR\]).||80.1|29.4|0.0009
71883679|NCT03988335|143287145|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2-sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.24|||||||Hochberg's method|||||||0.24
71883680|NCT03988335|143287146|OTHER|The primary endpoints were first tested at alpha of 10% (2-sided). If the larger p-value was less than 10% (2sided), both primary endpoints were to be declared statistically significant. If the larger p-value was greater than 10%, but the smaller p-value was less than 5% (2-sided), then the primary endpoint with the smaller p-value was to be declared statistically significant.||||||0.804|||||||Hochberg's method|||||||0.804
71943950|NCT01015625|143410129|SUPERIORITY|A two-sided significance level of 5% was used.|Cox Proportional Hazard|0.95||||0.89|TWO_SIDED|95.0|0.45|2.02|||Log Rank||From the Cox Proportional hazard model with surgery vs no surgery fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter time to local progression for surgery relative to no surgery.|To determine the effect of local therapy (surgery) compared to systemic therapy only in synchronous metastasized breast cancer patients in terms of time from randomization to local progression. Local progression is defined as recurrence in breast with localization mamma, chest wall or axilla. Participants last known to be alive, who did not experience a local progression were censored at their last contact date or at the data cut-off date whichever came first.||2.02|0.45|0.890
71700375|NCT01013753|142916422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.111|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.203|0.111|<0.0001
71761827|NCT04857320|143025456|SUPERIORITY|||||||0|||||||ANOVA|||||||0
71883681|NCT03594227|143287177|SUPERIORITY||Mean Difference (Net)|-19.26|STANDARD_ERROR_OF_MEAN|5.02||0.011|TWO_SIDED|95.0|-33.98|-4.54||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.54|-33.98|0.011
71883682|NCT03594227|143287177|SUPERIORITY||Mean Difference (Final Values)|-24.08|STANDARD_ERROR_OF_MEAN|5.02||0.001|TWO_SIDED|95.0|-38.8|-9.36||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-9.36|-38.80|0.001
71883683|NCT03594227|143287177|SUPERIORITY||Mean Difference (Final Values)|-19.54|STANDARD_ERROR_OF_MEAN|5.133||0.01|TWO_SIDED|95.0|-34.41|-4.67||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||The planned sample size is approximately 95 enrolled subjects with approximately 45 subjects enrolled with AT or AU. Because the primary efficacy analysis of mean percent reduction in hair loss using SALT scores is expected to be more sensitive than the SALT50 responder analysis, the power for the primary analysis is also expected to be no less than 80%.||-4.67|-34.41|0.010
71883684|NCT03594227|143287178|SUPERIORITY||Mean Difference (Final Values)|-19.17|STANDARD_ERROR_OF_MEAN|5.165||0.013|TWO_SIDED|95.0|-34.33|-4.02|||Mixed Models Analysis|||||-4.02|-34.33|0.013
71883685|NCT03594227|143287178|SUPERIORITY||Mean Difference (Net)|-24.53|STANDARD_ERROR_OF_MEAN|5.165||0.002|TWO_SIDED|95.0|-39.69|-9.38|||Mixed Models Analysis|||||-9.38|-39.69|0.002
71761828|NCT03436082|143025460|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.04|||||||Chi-squared|||||||0.04
71883686|NCT03594227|143287178|SUPERIORITY||Mean Difference (Net)|-19.17|STANDARD_ERROR_OF_MEAN|5.281||0.014|TWO_SIDED|95.0|-34.48|-3.86|||Mixed Models Analysis|||||-3.86|-34.48|0.014
71883687|NCT03594227|143287179|SUPERIORITY||Mean Difference (Net)|-11.29|STANDARD_ERROR_OF_MEAN|3.359||0.025|TWO_SIDED|95.0|-21.14|-1.45|||Mixed Models Analysis|||||-1.45|-21.14|0.025
71883688|NCT03594227|143287179|SUPERIORITY||Mean Difference (Net)|-15.25|STANDARD_ERROR_OF_MEAN|3.359||0.003|TWO_SIDED|95.0|-25.1|-5.4|||Mixed Models Analysis|||||-5.40|-25.10|0.003
71883689|NCT03594227|143287179|SUPERIORITY||Mean Difference (Net)|-17.55|STANDARD_ERROR_OF_MEAN|3.434|<|0.001|TWO_SIDED|95.0|-27.49|-7.6|||Mixed Models Analysis|||||-7.60|-27.49|<0.001
71883690|NCT03594227|143287180|SUPERIORITY||Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|3.599||0.008|TWO_SIDED|95.0|-24.95|-3.84|||Mixed Models Analysis|||||-3.84|-24.95|0.008
71883691|NCT03594227|143287180|SUPERIORITY||Mean Difference (Net)|-19.01|STANDARD_ERROR_OF_MEAN|3.599|<|0.001|TWO_SIDED|95.0|-29.56|-8.45|||Mixed Models Analysis|||||-8.45|-29.56|<0.001
71883692|NCT03594227|143287180|SUPERIORITY||Mean Difference (Net)|-17.52|STANDARD_ERROR_OF_MEAN|3.679||0.001|TWO_SIDED|95.0|-28.18|-6.86|||Mixed Models Analysis|||||-6.86|-28.18|0.001
71883693|NCT03594227|143287181|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
71883694|NCT03594227|143287181|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
71883695|NCT03594227|143287181|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
71883696|NCT03594227|143287182|SUPERIORITY||Odds Ratio (OR)|4.6||||0.124|TWO_SIDED|95.0|0.7|31.8|||Mixed Models Analysis|||||31.8|0.7|0.124
71700376|NCT01013753|142916422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.051|0.143|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.143|0.051|<0.0001
71883697|NCT03594227|143287182|SUPERIORITY||Odds Ratio (OR)|5.6||||0.079|TWO_SIDED|95.0|0.8|38.3|||Mixed Models Analysis|||||38.3|0.8|0.079
71883698|NCT03594227|143287182|SUPERIORITY||Odds Ratio (OR)|3.9||||0.177|TWO_SIDED|95.0|0.5|27.7|||Mixed Models Analysis|||||27.7|0.5|0.177
71883699|NCT03594227|143287183|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
71700377|NCT01013753|142916423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.028||0.0952||95.0|-0.008|0.103|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.103|-0.008|0.0952
71883700|NCT03594227|143287183|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
71883701|NCT03594227|143287183|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|||||||0.367
71883702|NCT03594227|143287184|SUPERIORITY|||||||0.187|||||||Wilcoxon (Mann-Whitney)|||||||0.187
71883703|NCT03594227|143287184|SUPERIORITY|||||||0.375|||||||Wilcoxon (Mann-Whitney)|||||||0.375
71883704|NCT03594227|143287184|SUPERIORITY|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
71883705|NCT03594227|143287185|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||||||0.444
71883706|NCT03594227|143287185|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
71883707|NCT03594227|143287185|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
71883708|NCT03594227|143287186|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
71883709|NCT03594227|143287186|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
71883710|NCT03594227|143287186|SUPERIORITY|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||||||0.101
71883711|NCT03594227|143287187|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
71883712|NCT03594227|143287187|SUPERIORITY|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
71883713|NCT03594227|143287187|SUPERIORITY|||||||0.159|||||||Wilcoxon (Mann-Whitney)|||||||0.159
71883714|NCT03594227|143287188|SUPERIORITY|||||||0.407|||||||Wilcoxon (Mann-Whitney)|||||||0.407
71883715|NCT03594227|143287188|SUPERIORITY|||||||0.894|||||||Wilcoxon (Mann-Whitney)|||||||0.894
71883716|NCT03594227|143287188|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||||||0.179
71883717|NCT03594227|143287189|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
71883718|NCT03594227|143287189|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
71883719|NCT03594227|143287189|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
71883720|NCT03594227|143287190|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71883721|NCT03594227|143287190|SUPERIORITY|||||||0.154|||||||Wilcoxon (Mann-Whitney)|||||||0.154
71883722|NCT03594227|143287190|SUPERIORITY|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
71883723|NCT03594227|143287191|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
71883724|NCT03594227|143287191|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.660
71883725|NCT03594227|143287191|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|||||||0.704
71883726|NCT03594227|143287192|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
71883727|NCT03594227|143287192|SUPERIORITY|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||||||0.911
71883728|NCT03594227|143287192|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
71883729|NCT03594227|143287193|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.430
71883730|NCT03594227|143287193|SUPERIORITY|||||||0.288|||||||Wilcoxon (Mann-Whitney)|||||||0.288
71883731|NCT03594227|143287193|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
71883732|NCT03594227|143287194|SUPERIORITY|||||||0.194|||||||Wilcoxon (Mann-Whitney)|||||||0.194
71883733|NCT03594227|143287194|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
71883734|NCT03594227|143287194|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71883735|NCT03594227|143287195|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||||||0.248
71883736|NCT03594227|143287195|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.150
71883737|NCT03594227|143287195|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
71883738|NCT03594227|143287196|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
71883739|NCT03594227|143287196|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
71883740|NCT03594227|143287196|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
71883741|NCT03594227|143287198|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
71883742|NCT03594227|143287198|SUPERIORITY|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
71883743|NCT03594227|143287198|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
71883744|NCT03594227|143287199|SUPERIORITY|||||||0.883|||||||Wilcoxon (Mann-Whitney)|||||||0.883
71761829|NCT03436082|143025462|OTHER|We used Stata version 14.2 (StataCorp LP) to perform chi-square tests to compare syncing of the Fitbit device and response rate for the postprocedure recovery PROMs and disease-specific PROMs between patients in the bariatric surgery and atrial fibrillation ablation groups, using a p value \< 0.05 to denote statistical significance.||||||0.85|||||||Chi-squared|||||||0.85
71883745|NCT03594227|143287199|SUPERIORITY|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||||||0.954
71943951|NCT02728102|143410130|SUPERIORITY||difference in the proportions|2.9||||0.3657|TWO_SIDED|80.0|-8.8|14.6||A one-sided significance level of 0.10 is used to assess whether the vaccine appears promising relative to control.|Z test|||The proportion of patients alive and in CR/sCR at 1 year post transplant will be described in the vaccine and no vaccine groups with 80% confidence intervals and compared between groups using a two-sample Z test comparing binomial proportions.||14.6|-8.8|0.3657
71943952|NCT02728102|143410130|EQUIVALENCE|The stratified odds ratio is estimated with 80% confidence intervals.|Odds Ratio (OR)|1.19||||0.7461|TWO_SIDED|80.0|0.7|2.03||P-value is provided by Breslow-Day Test for Homogeneity of the Odds Ratios.|Cochran-Mantel-Haenszel||The Cochran-Mantel-Haenszel Odds Ratio estimate is for the Stratification. Stratum 1 is sCR/CR at Randomization. Stratum 2 is VGPR/PR/Stable Response at Randomization.|A secondary analysis stratified on disease response prior to randomization between arms will be conducted using a Cochran-Mantel-Haenszel test, and a stratified odds ratio along with 80% confidence intervals will be estimated.||2.03|0.70|0.7461
71761830|NCT00950859|143025465|SUPERIORITY_OR_OTHER||percentage of participants|78.0|||||TWO_SIDED|95.0|58.0|91.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||91|58|
71761831|NCT00950859|143025465|SUPERIORITY_OR_OTHER||percentage of participants|96.0||||||95.0|79.0|100.0|||||The estimated value represents the percentage of participants with HIV-1 RNA \<400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.|||100|79|
71761832|NCT02917642|143025491|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.||||0.04
71761833|NCT02917642|143025492|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.||||0.94
71883746|NCT03594227|143287199|SUPERIORITY|||||||0.295|||||||Wilcoxon (Mann-Whitney)|||||||0.295
71761834|NCT02249832|143025493|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|||||<|0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||<0.001
71761835|NCT02249832|143025494|EQUIVALENCE|A significance level of 0.05 was used (two-sided).|||||<|0.001|||||||ANOVA|||A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||<0.001
71761836|NCT02249832|143025495|EQUIVALENCE|A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||||0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.001
71761837|NCT02563067|143025509|SUPERIORITY||Rate Ratio|0.69||||0.059|TWO_SIDED|95.0|0.5|0.96|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.96|0.50|0.059
71883747|NCT03594227|143287200|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
71883748|NCT03594227|143287200|SUPERIORITY|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
71883749|NCT03594227|143287200|SUPERIORITY|||||||0.815|||||||Wilcoxon (Mann-Whitney)|||||||0.815
71883750|NCT03594227|143287201|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||||||0.522
71883751|NCT03594227|143287201|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
71883752|NCT03594227|143287201|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
71943953|NCT02728102|143410130|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide/GM-CSF arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|7.2||||0.2429|TWO_SIDED|80.0|-6.4|20.6|||Z test|||A secondary pairwise analysis of CR/sCR rates comparing the vaccine arm to Lenalidomide/GM-CSF arm at 1 year post transplant.||20.6|-6.4|0.2429
71943954|NCT02728102|143410130|SUPERIORITY|The proportion of patients alive and in CR/sCR at 1 year post transplant will be compared in the vaccine arm to Lenalidomide alone arm with 80% confidence intervals using a two-sample Z test comparing binomial proportions.|difference in the proportions|-1.6||||0.4397|TWO_SIDED|80.0|-15.6|12.4|||Z test|||A secondary pairwise analysis of CR rates comparing the vaccine arm to Lenalidomide alone arm at 1 year post transplant.||12.4|-15.6|0.4397
71883753|NCT03594227|143287202|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.93||0.882|TWO_SIDED|95.0|-2.53|2.94|||Mixed Models Analysis|||||2.94|-2.53|0.882
71883754|NCT03594227|143287202|SUPERIORITY||Mean Difference (Net)|-3.58|STANDARD_ERROR_OF_MEAN|0.93||0.011|TWO_SIDED|95.0|-6.31|-0.84|||Mixed Models Analysis|||||-0.84|-6.31|0.011
71883755|NCT03594227|143287202|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.951||0.999|TWO_SIDED|95.0|-2.76|2.76|||Mixed Models Analysis|||||2.76|-2.76|0.999
71883756|NCT03594227|143287203|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
71883757|NCT03594227|143287203|SUPERIORITY|||||||0.319|||||||Wilcoxon (Mann-Whitney)|||||||0.319
71883758|NCT03594227|143287203|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
71883759|NCT03594227|143287204|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||||||0.584
71883760|NCT03594227|143287204|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
71761838|NCT02563067|143025509|SUPERIORITY||Rate Ratio|0.72||||0.114|TWO_SIDED|95.0|0.52|1.01|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.01|0.52|0.114
71761839|NCT02563067|143025510|SUPERIORITY||Mean Difference (Net)|0.15||||0.369|TWO_SIDED|95.0|-0.02|0.32|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.32|-0.02|0.369
71761840|NCT02563067|143025510|SUPERIORITY||Mean Difference (Net)|0.13||||0.824|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.30|-0.04|0.824
71943955|NCT02728102|143410131|SUPERIORITY|||||||0.9376||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.9376
71761841|NCT02563067|143025511|SUPERIORITY||Mean Difference (Net)|-0.17||||0.369|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.01|-0.36|0.369
71761842|NCT02563067|143025511|SUPERIORITY||Mean Difference (Net)|-0.09||||0.824|TWO_SIDED|95.0|-0.28|0.1|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.10|-0.28|0.824
71761843|NCT02563067|143025512|SUPERIORITY||Mean Difference (Net)|0.068||||0.369|TWO_SIDED|95.0|-0.018|0.154|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.154|-0.018|0.369
71761844|NCT02563067|143025512|SUPERIORITY||Mean Difference (Net)|0.038||||0.824|TWO_SIDED|95.0|-0.048|0.124|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.124|-0.048|0.824
71761845|NCT02563067|143025513|SUPERIORITY||Rate Ratio|0.82||||0.369|TWO_SIDED|95.0|0.62|1.07|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.07|0.62|0.369
71883761|NCT03594227|143287204|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
71883762|NCT03594227|143287205|SUPERIORITY|||||||0.341|||||||Wilcoxon (Mann-Whitney)|||||||0.341
71700378|NCT01013753|142916423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.028||0.0003||95.0|0.048|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.158|0.048|0.0003
71761846|NCT02563067|143025513|SUPERIORITY||Rate Ratio|0.76||||0.348|TWO_SIDED|95.0|0.58|1.0|||negative binomial regression model|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||1.00|0.58|0.348
71761847|NCT02563067|143025514|SUPERIORITY||Mean Difference (Net)|0.07||||0.824|TWO_SIDED|95.0|-0.07|0.21|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.21|-0.07|0.824
71883763|NCT03594227|143287205|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
71761848|NCT02563067|143025514|SUPERIORITY||Mean Difference (Net)|0.12||||0.824|TWO_SIDED|95.0|-0.02|0.26|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.26|-0.02|0.824
71761849|NCT02563067|143025515|SUPERIORITY||Mean Difference (Net)|-0.12||||0.824|TWO_SIDED|95.0|-0.28|0.03|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.03|-0.28|0.824
71761850|NCT02563067|143025515|SUPERIORITY||Mean Difference (Net)|-0.07||||0.824|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.08|-0.23|0.824
71761851|NCT02563067|143025516|SUPERIORITY||Mean Difference (Net)|0.05||||0.369|TWO_SIDED|95.0|-0.019|0.119|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.119|-0.019|0.369
71761852|NCT02563067|143025516|SUPERIORITY||Mean Difference (Net)|0.061||||0.595|TWO_SIDED|95.0|-0.008|0.13|||ANCOVA|adjusted p-value, closed testing procedure across the primary and key secondary null hypotheses. Overall type I error rate controlled at two-sided 5%.||||0.130|-0.008|0.595
71761853|NCT00839319|143025518|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Correlations between serum hormone levels and IT hormones, and between IT hormones were performed on 23 subjects in 4 groups using Spearmen technique.||||||<0.05
71761854|NCT03860259|143025615|SUPERIORITY|||||||0.1771||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1771
71761855|NCT03860259|143025615|SUPERIORITY|||||||0.2833||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2833
71883764|NCT03594227|143287205|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
71883765|NCT03594227|143287206|SUPERIORITY|||||||0.827|||||||Wilcoxon (Mann-Whitney)|||||||0.827
71883766|NCT03594227|143287206|SUPERIORITY|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
71883767|NCT03594227|143287206|SUPERIORITY|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
71883768|NCT03594227|143287207|SUPERIORITY|||||||0.836|||||||Wilcoxon (Mann-Whitney)|||||||0.836
71883769|NCT03594227|143287207|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.540
71883770|NCT03594227|143287207|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
71883771|NCT03594227|143287208|SUPERIORITY|||||||0.469|||||||Wilcoxon (Mann-Whitney)|||||||0.469
71883772|NCT03594227|143287208|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||||||0.219
71883773|NCT03594227|143287208|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
71883774|NCT00790907|143287209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.267|TWO_SIDED|95.0|0.54|1.19|||Regression, Logistic|||||1.19|0.54|0.267
71700379|NCT01013753|142916423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.028||0.0016||95.0|0.034|0.145|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.145|0.034|0.0016
71700380|NCT01013753|142916423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.071|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.183|0.071|<0.0001
71700381|NCT01013753|142916423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.028||0.0096||95.0|0.018|0.129|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.129|0.018|0.0096
71700382|NCT01013753|142916424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.147||95.0|-0.013|0.088|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.088|-0.013|0.1470
71700383|NCT01013753|142916424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0003||95.0|0.042|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.141|0.042|0.0003
71700384|NCT01013753|142916424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.06|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.160|0.060|<0.0001
71700385|NCT01013753|142916424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.078|0.179|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.179|0.078|<0.0001
71700386|NCT01013753|142916424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.025||0.0448||95.0|0.001|0.101|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.101|0.001|0.0448
71700387|NCT01013753|142916425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.408|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.277|0.539|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.539|0.277|<0.0001
71700388|NCT01013753|142916425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.566|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.438|0.695|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.695|0.438|<0.0001
71700389|NCT01013753|142916425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.612|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.482|0.743|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.743|0.482|<0.0001
71700390|NCT01013753|142916425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.539|0.801|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.801|0.539|<0.0001
71700391|NCT01013753|142916425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|0.457|0.718|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.718|0.457|<0.0001
71700392|NCT01013753|142916426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.213|0.461|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.461|0.213|<0.0001
71761856|NCT03860259|143025615|SUPERIORITY|||||||0.0909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.0909
71761857|NCT03860259|143025615|SUPERIORITY|||||||0.231||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.2310
71883775|NCT01888640|143287217|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.008|TWO_SIDED|95.0|-1.8|-0.2||To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni's method|Linear mixed models for repeated measure|||Visit 2-Visit 3||-0.2|-1.8|0.008
71700393|NCT01013753|142916426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.485|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.363|0.606|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.606|0.363|<0.0001
71700394|NCT01013753|142916426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.531|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.408|0.655|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.655|0.408|<0.0001
71700395|NCT01013753|142916426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.648|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.524|0.772|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.772|0.524|<0.0001
71700396|NCT01013753|142916426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.551|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.428|0.674|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.674|0.428|<0.0001
71761858|NCT03860259|143025615|SUPERIORITY|||||||0.0801|||||||t-test, 1 sided|||120 hrs||||0.0801
71761859|NCT03860259|143025615|SUPERIORITY|||||||0.0307||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Total||||0.0307
71761860|NCT03860259|143025616|SUPERIORITY|||||||0.1956||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.1956
71761861|NCT03860259|143025616|SUPERIORITY|||||||0.2274||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.2274
71761862|NCT03860259|143025616|SUPERIORITY|||||||0.109||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1090
71761863|NCT03860259|143025616|SUPERIORITY|||||||0.1618||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.1618
71761864|NCT03860259|143025616|SUPERIORITY|||||||0.1264||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.1264
71761865|NCT03860259|143025616|SUPERIORITY|||||||0.0394||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.0394
71761866|NCT03860259|143025616|SUPERIORITY|||||||0.3968||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.3968
71761867|NCT03860259|143025616|SUPERIORITY|||||||0.3407||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.3407
71761868|NCT03860259|143025616|SUPERIORITY|||||||0.4033||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4033
71761869|NCT03860259|143025617|SUPERIORITY|||||||0.1707||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.1707
71761870|NCT03860259|143025617|SUPERIORITY|||||||0.3446||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3446
71761871|NCT03860259|143025617|SUPERIORITY|||||||0.431|||||||t-test, 1 sided|||48 hrs||||0.4310
71700397|NCT01013753|142916427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.373|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.253|0.493|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.493|0.253|<0.0001
71761872|NCT03860259|143025617|SUPERIORITY|||||||0.3143||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.3143
71761873|NCT03860259|143025617|SUPERIORITY|||||||0.4749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4749
71761874|NCT03860259|143025617|SUPERIORITY|||||||0.3728||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.3728
71883776|NCT01888640|143287217|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.6|<0.0001
71883777|NCT01888640|143287218|SUPERIORITY||Mean Difference (Net)|-1.3||||0.002|TWO_SIDED|95.0|-2.2|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.2|0.002
71761875|NCT03860259|143025617|SUPERIORITY|||||||0.1628|||||||t-test, 1 sided|||Day 14||||0.1628
71761876|NCT03860259|143025617|SUPERIORITY|||||||0.0731||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.0731
71761877|NCT03860259|143025617|SUPERIORITY|||||||0.4909||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60||||0.4909
71761878|NCT03860259|143025617|SUPERIORITY|||||||0.4411||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.4411
71761879|NCT03860259|143025618|SUPERIORITY|||||||0.1786||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Acetaminophen||||0.1786
71761880|NCT03860259|143025618|SUPERIORITY|||||||0.1876||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Ibuprofen||||0.1876
71761881|NCT03860259|143025619|SUPERIORITY|||||||0.3638||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline PCS||||0.3638
71761882|NCT03860259|143025619|SUPERIORITY|||||||0.0856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 PCS||||0.0856
71761883|NCT03860259|143025619|SUPERIORITY|||||||0.4428||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 PCS||||0.4428
71761884|NCT03860259|143025619|SUPERIORITY|||||||0.3378||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 PCS||||0.3378
71761885|NCT03860259|143025619|SUPERIORITY|||||||0.3942||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 PCS||||0.3942
71761886|NCT03860259|143025619|SUPERIORITY|||||||0.219||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Baseline MCS||||0.2190
71761887|NCT03860259|143025619|SUPERIORITY|||||||0.1112||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14 MCS||||0.1112
71761888|NCT03860259|143025619|SUPERIORITY|||||||0.1737||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30 MCS||||0.1737
71761889|NCT03860259|143025619|SUPERIORITY|||||||0.2408||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 60 MCS||||0.2408
71883778|NCT01888640|143287218|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-2.8|<0.0001
71883779|NCT01888640|143287219|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-2.1|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.1|0.0006
71761890|NCT03860259|143025619|SUPERIORITY|||||||0.038||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90 MCS||||0.0380
71761891|NCT03860259|143025620|SUPERIORITY|||||||0.222||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2220
71761892|NCT03860259|143025621|SUPERIORITY|||||||0.2856||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||||||0.2856
71761893|NCT03860259|143025624|SUPERIORITY|||||||0.2241|||||||t-test, 1 sided|||||||0.2241
71761894|NCT03860259|143025625|SUPERIORITY|||||||0.2714||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Time of discharge||||0.2714
71761895|NCT03860259|143025625|SUPERIORITY|||||||0.3749||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||24 hrs||||0.3749
71761896|NCT03860259|143025625|SUPERIORITY|||||||0.3862||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||48 hrs||||0.3862
71761897|NCT03860259|143025625|SUPERIORITY|||||||0.1735||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||72 hrs||||0.1735
71761898|NCT03860259|143025625|SUPERIORITY|||||||0.4304||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||96 hrs||||0.4304
71761899|NCT03860259|143025625|SUPERIORITY|||||||0.4902||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||120 hrs||||0.4902
71883780|NCT01888640|143287219|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.2|<0.0001
71883781|NCT01888640|143287220|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.001|TWO_SIDED|95.0|-2.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-2.4|0.001
71761900|NCT03860259|143025625|SUPERIORITY|||||||0.4371||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 14||||0.4371
71761901|NCT03860259|143025625|SUPERIORITY|||||||0.195||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 30||||0.1950
71761902|NCT03860259|143025625|SUPERIORITY|||||||0.4124|||||||t-test, 1 sided|||Day 60||||0.4124
71761903|NCT03860259|143025625|SUPERIORITY|||||||0.0268||||||P value less than 0.1 will be considered significant|t-test, 1 sided|||Day 90||||0.0268
71761904|NCT02280408|143025657|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761905|NCT02280408|143025657|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761906|NCT02280408|143025657|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761907|NCT02280408|143025657|OTHER|||||||0.01|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.010
71822588|NCT05677867|143147856|OTHER||Ratio of Adjusted Means|94.7|||||TWO_SIDED|90.0|81.4|110.18|||||The ratios (and 90% CIs) are expressed as percentages.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios. Formulation A was the Reference treatment while Formulation B was the Test treatment.||110.18|81.40|
71822589|NCT04004208|143147861|NON_INFERIORITY|Non inferiority margin is 5%. Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.034|||||TWO_SIDED|90.0|-0.08|0.162||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.162|-0.08|
71883782|NCT01888640|143287220|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.9|-0.9|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.9|-2.9|<0.0001
71761908|NCT02280408|143025657|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
71883783|NCT01888640|143287221|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.011|TWO_SIDED|95.0|-2.2|-0.2|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.2|-2.2|0.011
71943956|NCT02728102|143410131|SUPERIORITY|||||||0.4887||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 6 months Post Transplant.||||0.4887
71761909|NCT02280408|143025657|OTHER|||||||0.969|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.969
71761910|NCT02280408|143025658|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71761911|NCT02280408|143025658|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71761912|NCT02280408|143025658|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71761913|NCT02280408|143025658|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71761914|NCT02280408|143025658|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||<0.001
71761915|NCT02280408|143025658|OTHER|||||||0.733|||||||ANOVA|Adjustments for multiple comparisons were not performed||||||0.733
71761916|NCT02280408|143025659|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761917|NCT02280408|143025659|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761918|NCT02280408|143025659|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761919|NCT02280408|143025659|OTHER|||||||0.132|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.132
71761920|NCT02280408|143025659|OTHER|||||||0.07|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.070
71761921|NCT02280408|143025659|OTHER|||||||0.743|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.743
71761922|NCT02280408|143025660|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761923|NCT02280408|143025660|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761924|NCT02280408|143025660|OTHER||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||<0.001
71761925|NCT02280408|143025660|OTHER|||||||0.014|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.014
71761926|NCT02280408|143025660|OTHER|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.011
71761927|NCT02280408|143025660|OTHER|||||||0.923|||||||ANOVA|Adjustments for multiple comparisons were not performed.||||||0.923
71761928|NCT05300763|143025671|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|1.25|3.22|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.22|1.25|
71761929|NCT05300763|143025672|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (96.25%) confidence interval is above 1.|Odds Ratio (OR)|2.0|||||TWO_SIDED|96.25|1.18|3.41|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.41|1.18|
71761930|NCT05300763|143025673|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided adjusted (97.5 %) confidence interval is above 1.|Odds Ratio (OR)|2.17|||||TWO_SIDED|97.5|1.3|3.64|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.64|1.30|
71761931|NCT05300763|143025674|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval is above 1.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.04|3.02|||Linear Mixed Model||Odds Ratio was calculated as Test over Control.|||3.02|1.04|
71761932|NCT01594528|143025675|OTHER|||||||0.992||||||comparison between groups for body indicators|Wilcoxon (Mann-Whitney)|||||||0.992
71761933|NCT01594528|143025675|OTHER|||||||0.8||||||comparison between groups facial indicators|Wilcoxon (Mann-Whitney)|||||||0.8
71761934|NCT01594528|143025675|OTHER|||||||0.586||||||comparison between groups for vocal indicators|Wilcoxon (Mann-Whitney)|||||||0.586
71883784|NCT01888640|143287221|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.0|-3.0|<0.0001
71700398|NCT01013753|142916427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.409|0.645|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.645|0.409|<0.0001
71700399|NCT01013753|142916427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.572|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.453|0.692|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.692|0.453|<0.0001
71700400|NCT01013753|142916427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.54|0.781|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.781|0.540|<0.0001
71700401|NCT01013753|142916427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.451|0.689|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.689|0.451|<0.0001
71700402|NCT01013753|142916428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.168|0.436|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.436|0.168|<0.0001
71700403|NCT01013753|142916428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.429|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.297|0.561|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.561|0.297|<0.0001
71700404|NCT01013753|142916428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.333|0.599|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.599|0.333|<0.0001
71700405|NCT01013753|142916428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.4|0.669|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.669|0.400|<0.0001
71700406|NCT01013753|142916428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.371|0.637|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.637|0.371|<0.0001
71700407|NCT01013753|142916429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.07||0.0002||95.0|0.127|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.401|0.127|0.0002
71700408|NCT01013753|142916429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.333|0.602|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.602|0.333|<0.0001
71700409|NCT01013753|142916429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.348|0.62|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.620|0.348|<0.0001
71700410|NCT01013753|142916429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.624|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.487|0.761|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.761|0.487|<0.0001
71700411|NCT01013753|142916429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.447|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|0.311|0.583|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.583|0.311|<0.0001
71700412|NCT01013753|142916430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.012|STANDARD_ERROR_OF_MEAN|3.671|<|0.0001||95.0|14.802|29.223|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||29.223|14.802|<0.0001
71700413|NCT01013753|142916430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.022|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001||95.0|21.931|36.114|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||36.114|21.931|<0.0001
71700414|NCT01013753|142916430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.887|STANDARD_ERROR_OF_MEAN|3.631|<|0.0001||95.0|20.755|35.019|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.019|20.755|<0.0001
71700415|NCT01013753|142916430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.935|STANDARD_ERROR_OF_MEAN|3.668|<|0.0001||95.0|25.73|40.139|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||40.139|25.730|<0.0001
71700416|NCT01013753|142916430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.528|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001||95.0|16.371|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||30.686|16.371|<0.0001
71700417|NCT01013753|142916431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001||95.0|7.77|22.071|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||22.071|7.770|<0.0001
71943957|NCT02728102|143410131|SUPERIORITY|||||||0.5176||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 6 months Post Transplant.||||0.5176
71738811|NCT01363908|142990423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2609|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.2609
71822590|NCT04004208|143147862|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|-0.023|||||TWO_SIDED|90.0|-0.11|0.046||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.046|-0.11|
71822591|NCT04004208|143147863|OTHER|Confidence interval actually refers to a credible interval based on the Bayesian analysis.|Difference in proportions|0.096|||||TWO_SIDED|90.0|0.019|0.175||||||Bayesian analysis with non-informative prior distributions. Calculation of two-sided 90% credible interval for the treatment difference (aflibercept - laser photocoagulation).||0.175|0.019|
71822592|NCT00839982|143147876|SUPERIORITY|||||||0.03||||||Hypothesis: achieving CR provides an overall longer survival.|Chi-squared|||||||0.03
71822593|NCT00087490|143147881|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.|Percent Difference|4.2||||0.249|TWO_SIDED|95.0|-3.0|11.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).||11.5|-3.0|0.249
71822594|NCT00087490|143147882|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|3.9||||0.168|TWO_SIDED|95.0|-1.7|9.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||9.5|-1.7|0.168
71822595|NCT00087490|143147883|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.1||||0.048|TWO_SIDED|95.0|0.1|14.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||14.2|0.1|0.048
71883785|NCT01888640|143287222|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-2.2|0.016
71883786|NCT01888640|143287222|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0002|TWO_SIDED|95.0|-2.6|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.6|-2.6|0.0002
71883787|NCT01888640|143287223|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.074|TWO_SIDED|95.0|-10.4|0.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.3|-10.4|0.074
71883788|NCT01888640|143287223|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.005|TWO_SIDED|95.0|-12.4|-1.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-1.8|-12.4|0.005
71883789|NCT01888640|143287224|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.018|TWO_SIDED|95.0|-1.7|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.1|-1.7|0.018
71700418|NCT01013753|142916431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.834|STANDARD_ERROR_OF_MEAN|3.58|<|0.0001||95.0|17.801|31.866|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||31.866|17.801|<0.0001
71761935|NCT00670306|143025755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_DEVIATION|7.1|<|0.001|||||||t-test, 2 sided|||||||<0.001
71761936|NCT04193189|143025764|NON_INFERIORITY|Pre-specified non-inferiority margin (2-CpG minus 3-alum): -10%.|Common proportion difference|12.5|||||TWO_SIDED|97.5|4.1|20.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||20.9|4.1|
71761937|NCT04193189|143025764|SUPERIORITY||Common proportion difference|18.4|||||TWO_SIDED|97.5|10.4|26.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe repeated confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Primary objective of Group A||26.2|10.4|
71761938|NCT04193189|143025764|SUPERIORITY||Common proportion difference|6.0|||||TWO_SIDED|97.5|-0.2|11.8|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Secondary objective of Group A||11.8|-0.2|
71761939|NCT04193189|143025766|SUPERIORITY||Common proportion difference|9.0|||||TWO_SIDED|97.5|0.1|18.1|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 4 weeks post last scheduled vaccination (Week 8 in 2-CpG, Week 28 in 3-alum)||18.1|0.1|
71761940|NCT04193189|143025766|SUPERIORITY||Common proportion difference|19.0|||||TWO_SIDED|97.5|10.0|27.9|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 12 in 2-CpG, Week 32 in 3-alum)||27.9|10.0|
71761941|NCT04193189|143025766|SUPERIORITY||Common proportion difference|27.8|||||TWO_SIDED|97.5|17.7|37.2|||||Common SP proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 28 in 2-CpG, Week 48 in 3-alum)||37.2|17.7|
71761942|NCT04193189|143025766|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|21.3|42.3|||||Common SPR proportion (expressed as percentage of participants) difference (2-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 2-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 52 in 2-CpG, Week 72 in 3-alum)||42.3|21.3|
71761943|NCT04193189|143025766|SUPERIORITY||Common proportion difference|23.8|||||TWO_SIDED|97.5|15.5|32.3|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 8 weeks post last scheduled vaccination (Week 32)||32.3|15.5|
71822596|NCT00087490|143147884|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|4.8||||0.09|TWO_SIDED|95.0|-0.7|10.3|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||10.3|-0.7|0.090
71822597|NCT00087490|143147885|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|6.6||||0.127|TWO_SIDED|95.0|-1.9|15.0|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.0|-1.9|0.127
71822598|NCT00087490|143147886|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|16.6||||0|TWO_SIDED|95.0|9.0|24.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||24.2|9.0|0.000
71822599|NCT00087490|143147887|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.7||||0.051|TWO_SIDED|95.0|0.0|15.4|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||15.4|-0.0|0.051
71822600|NCT00087490|143147888|NON_INFERIORITY_OR_EQUIVALENCE|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|15.0||||0|TWO_SIDED|95.0|8.2|21.8|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.||21.8|8.2|0.000
71822601|NCT00087490|143147891|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.022
71883790|NCT01888640|143287224|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.0006|TWO_SIDED|95.0|-1.9|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.9|0.0006
71943958|NCT02728102|143410131|SUPERIORITY|||||||0.2461||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between lenalidomide/GM-CSF arm and lenalidomide alone arm at 6 months Post Transplant.||||0.2461
71943959|NCT02728102|143410131|SUPERIORITY|||||||0.253||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 1 year Post Transplant.||||0.2530
71738812|NCT01363908|142990423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219|TWO_SIDED|||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.9219
71822602|NCT00087490|143147892|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.||||0.016
71822603|NCT00087490|143147893|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
71822604|NCT00087490|143147894|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||t-test, 2 sided|||||||0.000
71822605|NCT01253980|143147898|SUPERIORITY_OR_OTHER||Relative risk|0.6|||>|0.5|TWO_SIDED|95.0|0.11|3.37|||Fisher Exact|||||3.37|0.11|>0.50
71822606|NCT01700530|143147899|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71822607|NCT04883346|143147903|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_DEVIATION|3.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 32 degrees of freedom (one participant did not have baseline DEXA data so could not be included.||||||<0.001
71822608|NCT04883346|143147904|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom.||||||<0.001
71822609|NCT04883346|143147905|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.1|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
71822610|NCT04883346|143147906|SUPERIORITY|Paired t-test.|Mean Difference (Final Values)|-4.4|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||t-test, 2 sided|Paired t-test, 33 degrees of freedom||||||<0.001
71822611|NCT04529538|143147915|OTHER||GMT Ratio|0.68|||||TWO_SIDED|95.0|0.252|1.838|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of Type 1 neutralizing antibody GMT at Day 29||1.838|0.252|
71822612|NCT04529538|143147916|OTHER||GMT Ratio|1.26|||||TWO_SIDED|95.0|0.232|6.833|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 29||6.833|0.232|
71883791|NCT01888640|143287225|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.043|TWO_SIDED|95.0|-1.3|-0.01|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.01|-1.3|0.043
71883792|NCT01888640|143287225|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.048|TWO_SIDED|95.0|-1.3|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.3|0.048
71883793|NCT01888640|143287226|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.036|TWO_SIDED|95.0|-1.0|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.0|-1.0|0.036
71883794|NCT01888640|143287226|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||-0.4|-1.4|<0.0001
71883795|NCT01888640|143287227|SUPERIORITY||Mean Difference (Final Values)|-0.4|||>|0.99|TWO_SIDED|95.0|-2.3|1.5|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.5|-2.3|>0.99
71883796|NCT01888640|143287227|SUPERIORITY||Mean Difference (Final Values)|-0.6|||>|0.99|TWO_SIDED|95.0|-2.4|1.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.3|-2.4|>0.99
71883797|NCT01888640|143287228|SUPERIORITY||Mean Difference (Final Values)|1.1|||>|0.99|TWO_SIDED|95.0|-1.9|4.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||4.1|-1.9|>0.99
71883798|NCT01888640|143287228|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.17|TWO_SIDED|95.0|-0.6|5.3|||Linear mixed models for repeated measure|||||5.3|-0.6|0.17
71883799|NCT01888640|143287229|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.36|TWO_SIDED|95.0|-0.7|3.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||3.1|-0.7|0.36
71883800|NCT01888640|143287229|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-0.8|2.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||2.8|-0.8|0.58
71883801|NCT01888640|143287230|SUPERIORITY||Mean Difference (Final Values)|19.0|||>|0.99|TWO_SIDED|95.0|-58.0|96.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||96|-58|>0.99
71883802|NCT01888640|143287230|SUPERIORITY||Mean Difference (Final Values)|42.0|||>|0.99|TWO_SIDED|95.0|-34.0|117.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||117|-34|>0.99
71883803|NCT01888640|143287231|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.96|TWO_SIDED|95.0|-0.2|0.7|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||0.7|-0.2|0.96
71883804|NCT01888640|143287231|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.008|TWO_SIDED|95.0|0.1|1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3||1.0|0.1|0.008
71943960|NCT02728102|143410131|SUPERIORITY|||||||0.2213||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 1 year Post Transplant.||||0.2213
71700419|NCT01013753|142916431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.613|STANDARD_ERROR_OF_MEAN|3.601|<|0.0001||95.0|16.539|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||30.686|16.539|<0.0001
71883805|NCT01888640|143287232|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
71883806|NCT01888640|143287232|SUPERIORITY||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3||||>0.99
71883807|NCT03389854|143287237|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
71883808|NCT03389854|143287237|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.90
71943961|NCT02728102|143410131|SUPERIORITY|||||||0.493||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 1 year Post Transplant.||||0.4930
71883809|NCT03389854|143287238|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.001
71883810|NCT03389854|143287238|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.40
71883811|NCT03389854|143287239|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.01
71883812|NCT03389854|143287239|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Control group vs. Penile Traction Therapy Group at 6 months||||0.64
71883813|NCT03389854|143287240|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 3 months||||0.06
71883814|NCT03389854|143287240|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Control group vs Penile Traction Therapy Group at 6 months||||0.66
71883815|NCT03389854|143287241|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71883816|NCT03389854|143287242|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71883817|NCT03389854|143287243|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71883818|NCT00391222|143287278|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|95.0||||As defined in the protocol, the olanzapine arm was not included in the primary outcome comparison. Data on the olanzapine arm are presented in outcome measure 7.|Log Rank|||Comparison between risperidone LAI and placebo was performed using a log-rank test controlling for patient type at screening (acute or non-acute) and for geographic region. As recurrence rates at 9 months were assumed to be 45% for risperidone LAI and 68% for placebo, the study would have approximately 90% power to detect a clinically meaningful difference of 23% in recurrence rates of a mood episode if in Period III 100 patients were randomized to each of the 2 relevant treatment arms.||||0.057
71883819|NCT00391222|143287279|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.005
71883820|NCT00391222|143287279|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
71883821|NCT00391222|143287280|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.655
71883822|NCT00391222|143287280|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.011
71943962|NCT02728102|143410131|SUPERIORITY|||||||0.6591||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 1 year Post Transplant.||||0.6591
71883823|NCT00391222|143287281|SUPERIORITY_OR_OTHER|||||||0.2882|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||0.2882
71883824|NCT00391222|143287281|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.||||<0.0001
71883825|NCT00391222|143287282|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
71883826|NCT00391222|143287282|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||<0.001
71883827|NCT00391222|143287283|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.480
71883828|NCT00391222|143287283|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.||||0.001
71883829|NCT00960843|143287286|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||t-test, 2 sided|||Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.||||0.0520
71883830|NCT00960843|143287287|SUPERIORITY_OR_OTHER|||||||0.0225||95.0|||||t-test, 2 sided|||||||0.0225
71883831|NCT00960843|143287288|SUPERIORITY_OR_OTHER|||||||0.0193||95.0|||||t-test, 2 sided|||||||0.0193
71883832|NCT01181011|143287299|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.22|STANDARD_ERROR_OF_MEAN|1.06||0.0107||90.0|99.45|119.95||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||119.95|99.45|0.0107
71883833|NCT01181011|143287300|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.84|STANDARD_ERROR_OF_MEAN|1.06||0.0139|TWO_SIDED|90.0|99.96|120.71||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||120.71|99.96|0.0139
71883834|NCT01181011|143287301|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|97.57|STANDARD_ERROR_OF_MEAN|1.09||0.0126|TWO_SIDED|90.0|84.643|112.472||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.472|84.643|0.0126
71700420|NCT01013753|142916431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.449|STANDARD_ERROR_OF_MEAN|3.637|<|0.0001||95.0|21.305|35.594|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||35.594|21.305|<0.0001
71883835|NCT01181011|143287302|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|109.7|STANDARD_ERROR_OF_MEAN|1.04||0.0011|TWO_SIDED|90.0|102.87|117.07||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||117.07|102.87|0.0011
71883836|NCT01181011|143287303|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|108.8|STANDARD_ERROR_OF_MEAN|1.04||0.0006|TWO_SIDED|95.0|102.1|116.0||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||116.0|102.1|0.0006
71883837|NCT01181011|143287304|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|gMean Ratio|106.7|STANDARD_ERROR_OF_MEAN|1.03||0|TWO_SIDED|90.0|100.9|112.9||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA|||||112.9|100.9|0.000
71883838|NCT01223703|143287341|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||"null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.~for unpaired data."||||< 0.05
71883839|NCT01223703|143287342|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||||||< 0.05
71883840|NCT00852995|143287345|SUPERIORITY_OR_OTHER|||||||0.00028|TWO_SIDED||||||t-test, 2 sided|||||||0.00028
71883841|NCT00852995|143287345|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||t-test, 2 sided|||||||0.0899
71883842|NCT00852995|143287345|SUPERIORITY_OR_OTHER|||||||0.1586|TWO_SIDED||||||t-test, 2 sided|||||||0.1586
71883843|NCT00852995|143287345|SUPERIORITY_OR_OTHER|||||||0.0295|TWO_SIDED||||||t-test, 2 sided|||||||0.0295
71883844|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED|||||Treatment Week 01|ANCOVA|||||||.037
71883845|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||Treatment Week 02|ANCOVA|||||||.064
71883846|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Treatment Week 03|ANCOVA|||||||.161
71883847|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Treatment Week 04|ANCOVA|||||||.39
71883848|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||Treatment Week 05|ANCOVA|||||||.079
71883849|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||Treatment Week 06|ANCOVA|||||||.069
71883850|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Treatment Week 07|ANCOVA|||||||.026
71883851|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED|||||Treatment Week 08|ANCOVA|||||||.133
71883852|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|||||Treatment Week 09|ANCOVA|||||||.089
71883853|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED|||||Treatment Week 10|ANCOVA|||||||.057
71883854|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||Treatment Week 11|ANCOVA|||||||.127
71883855|NCT00852995|143287347|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||Treatment Week 12|ANCOVA|||||||0.395
71883856|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.0133
71883857|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.3839|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.3839
71883858|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.5721|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.5721
71883859|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED|||||Visit 02|Cochran-Mantel-Haenszel|||||||0.232
71883860|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0787|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.0787
71883861|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.7919|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.7919
71700421|NCT01013753|142916431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.439|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001||95.0|13.341|27.538|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||27.538|13.341|<0.0001
71883862|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.6881|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.6881
71883863|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.9832|TWO_SIDED|||||Visit 03|Cochran-Mantel-Haenszel|||||||0.9832
71883864|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0466|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.0466
71883865|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.8435|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8435
71883866|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.8743|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.8743
71883867|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.2884|TWO_SIDED|||||Visit 04|Cochran-Mantel-Haenszel|||||||0.2884
71883868|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0387|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.0387
71883869|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.8461|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.8461
71883870|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.9574
71883871|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.2994|TWO_SIDED|||||Visit 05|Cochran-Mantel-Haenszel|||||||0.2994
71883872|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.1024|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.1024
71883873|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.8759
71883874|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.9008|TWO_SIDED|||||Visit 06|Cochran-Mantel-Haenszel|||||||0.9008
71883875|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.4618|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4618
71883876|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.2439|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.2439
71883877|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.749
71883878|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.3749|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.3749
71883879|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Visit 07|Cochran-Mantel-Haenszel|||||||0.015
71883880|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0078
71883881|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.07
71883882|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.208
71883883|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0413|TWO_SIDED|||||Visit 08|Cochran-Mantel-Haenszel|||||||0.0413
71883884|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0054
71883885|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.2031|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.2031
71883886|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0894
71883887|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED|||||Visit 09|Cochran-Mantel-Haenszel|||||||0.0288
71883888|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.6964|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.6964
71883889|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.59
71883890|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.7146
71883891|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.5008|TWO_SIDED|||||Visit 10|Cochran-Mantel-Haenszel|||||||0.5008
71883892|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.1235|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1235
71883893|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.5488|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.5488
71883894|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.4343|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.4343
71883895|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.1114|TWO_SIDED|||||Visit 11|Cochran-Mantel-Haenszel|||||||0.1114
71883896|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.2119|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2119
71883897|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.0194|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.0194
71883898|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.506|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.506
71883899|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.2317|TWO_SIDED|||||Visit 12|Cochran-Mantel-Haenszel|||||||0.2317
71883900|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.1144
71883901|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.6786|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.6786
71883902|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.7735|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.7735
71883903|NCT00852995|143287348|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED|||||Visit 13|Cochran-Mantel-Haenszel|||||||0.758
71883904|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||0.017
71883905|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 04|Cochran-Mantel-Haenszel|||||||.041
71883906|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||Week 05|Cochran-Mantel-Haenszel|||||||.017
71883907|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Week 06|Cochran-Mantel-Haenszel|||||||.011
71883908|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Week 07|Cochran-Mantel-Haenszel|||||||.014
71883909|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||Week 08|Cochran-Mantel-Haenszel|||||||.029
71883910|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Week 09|Cochran-Mantel-Haenszel|||||||.021
71883911|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.041
71883912|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED|||||Week 10|Cochran-Mantel-Haenszel|||||||.044
71943963|NCT02728102|143410131|SUPERIORITY|||||||0.679||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine and the combined non-vaccine arms at 2 years Post Transplant.||||0.6790
71943964|NCT02728102|143410131|SUPERIORITY|||||||0.3124||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide/GM-CSF arm at 2 years Post Transplant.||||0.3124
71761944|NCT04193189|143025766|SUPERIORITY||Common proportion difference|32.3|||||TWO_SIDED|97.5|23.2|41.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 24 weeks post last scheduled vaccination (Week 48)||41.2|23.2|
71883913|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.013
71883914|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||Week 11|Cochran-Mantel-Haenszel|||||||.024
71883915|NCT00852995|143287349|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Week 12|Cochran-Mantel-Haenszel|||||||.027
71883916|NCT00852995|143287351|SUPERIORITY_OR_OTHER|||||||0.0211|TWO_SIDED|||||P-value for Kaplan-Meier Days to Closure|ANCOVA|||||||0.0211
71883917|NCT00852995|143287351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.83||||0.0212|TWO_SIDED|95.0|1.09|3.04|||Regression, Cox|||||3.04|1.09|.0212
71883918|NCT00852995|143287351|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||ANCOVA|||||||0.59
71883919|NCT00852995|143287351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.53|TWO_SIDED|95.0|0.69|2.05||This is the P-value for the Cox Hazard Ratio|Regression, Cox|||||2.05|.69|0.53
71883920|NCT00852995|143287351|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|Kaplan-Meier Days to Closure||||||0.26
71883921|NCT00852995|143287351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.19|TWO_SIDED|95.0|0.84|2.44||This is the P-value for the Cox Proportional Hazard Ratio|Regression, Cox|||||2.44|0.84|0.19
71883922|NCT00852995|143287351|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||P-value for Kaplan Meier Days to Closure|ANCOVA|||||||0.10
71883923|NCT00852995|143287351|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.06|TWO_SIDED|95.0|0.97|2.77||P-value for Cox Proportional Hazard Ratio|Regression, Cox|||||2.77|0.97|0.06
71883924|NCT03649061|143287358|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||To compare the two randomization groups, a linear mixed model with DAS28-CRP as outcome (Bell et al. 2014), including random intercepts per patient, adjusted for baseline DAS28-CRP, randomization timepoint, and RF and/or ACPA seropositivity was used.||||<0.05
71883925|NCT03649061|143287359|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||A binomial generalized linear mixed effect model for repeated measures of remission from randomization up until 28 weeks after was carried out, with adjustment for baseline DAS28-CRP, moment of randomization, and RF and/or ACPA seropositivity.||||<0.05
71883926|NCT00313209|143287394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|27.0|71.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||71|27|<0.0001
71883927|NCT00313209|143287395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|38.0|82.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||82|38|<0.0001
71883928|NCT00313209|143287396|SUPERIORITY_OR_OTHER||Rate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.12||0.1408|TWO_SIDED|95.0|0.58|1.08||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.08|0.58|0.1408
71883929|NCT00313209|143287397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4654|TWO_SIDED|95.0|-0.2|0.4||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.4|-0.2|0.4654
71883930|NCT00313209|143287398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.9||0.5457|TWO_SIDED|95.0|-1.2|2.2||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||2.2|-1.2|0.5457
71883931|NCT01332357|143287399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.56|2.46||The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|||||2.46|1.56|<0.0001
71943965|NCT02728102|143410131|SUPERIORITY|||||||0.7379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the vaccine arm and lenalidomide alone arm at 2 years Post Transplant.||||0.7379
71883932|NCT01332357|143287399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.42|2.25||The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication||||2.25|1.42|<0.0001
71883933|NCT01332357|143287399|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008|||<|0.0001|TWO_SIDED|95.0|1.005|1.011||The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction|Regression, Cox|Evaluates the impact of each day treatment with a controller was delayed||||1.011|1.005|<0.0001
71883934|NCT03784079|143287504|OTHER||Emax|-1.937|||||TWO_SIDED|95.0|-2.484|-1.389||||||||-1.389|-2.484|
71883935|NCT03784079|143287504|OTHER||EC50|7.094|||||TWO_SIDED|95.0|0.585|13.602||||||||13.602|0.585|
71883936|NCT03784079|143287504|OTHER||s2e|0.137|||||TWO_SIDED|95.0|0.062|0.212||||||||0.212|0.062|
71883937|NCT03784079|143287505|OTHER||Emax|-1.929|||||TWO_SIDED|95.0|-2.479|-1.379||||||||-1.379|-2.479|
71883938|NCT03784079|143287505|OTHER||EC50|0.446|||||TWO_SIDED|95.0|0.03|0.861||||||||0.861|0.030|
71883939|NCT03784079|143287505|OTHER||s2e|0.139|||||TWO_SIDED|95.0|0.063|0.216||||||||0.216|0.063|
71883940|NCT03784079|143287506|OTHER||Emax|-1.926|||||TWO_SIDED|95.0|-2.498|-1.354||||||||-1.354|-2.498|
71883941|NCT03784079|143287506|OTHER||EC50|0.197|||||TWO_SIDED|95.0|0.007|0.386||||||||0.386|0.007|
71943966|NCT02728102|143410131|SUPERIORITY|||||||0.2379||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||In this pairwise analysis, the proportion of participants alive and with sCR/CR/VGPR will be compared between the lenalidomide/GM-CSF arm and lenalidomide alone arm at 2 years Post Transplant.||||0.2379
71883942|NCT03784079|143287506|OTHER||s2e|0.144|||||TWO_SIDED|95.0|0.065|0.222||||||||0.222|0.065|
71700422|NCT01013753|142916432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.994|STANDARD_ERROR_OF_MEAN|0.507|<|0.0001||95.0|-2.989|-0.999|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.999|-2.989|<0.0001
71883943|NCT04099251|143287515|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||Regression, Cox|||||0.59|0.30|< 0.0001
71883944|NCT05032157|143287527|SUPERIORITY||Mean Difference (Final Values)|-7.68|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-9.91|-5.46|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|UAS7 at Week 12 (Scenario 1 with UAS7 as primary efficacy endpoint)||-5.46|-9.91|< 0.001
71883945|NCT05032157|143287528|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-4.29|-2.16|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE, biologics, week, baseline score, and both interaction of treatment by week and interaction of baseline score by week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.16|-4.29|<0.001
71883946|NCT05032157|143287529|SUPERIORITY||Mean Difference (Final Values)|-4.47|STANDARD_ERROR_OF_MEAN|0.634|<|0.001|TWO_SIDED|95.0|-5.71|-3.23|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti- IgE biologics, week, baseline score and both interaction of treatment by week and interaction of baseline score by week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-3.23|-5.71|< 0.001
71883947|NCT05032157|143287530|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.39|6.18|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Disease activity control (UAS7 =\< 6) at Week 12||6.18|2.39|< 0.001
71883948|NCT05032157|143287531|SUPERIORITY||Odds Ratio (OR)|5.78|||<|0.001|TWO_SIDED|95.0|2.83|11.78|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Complete absence of hives and itch (UAS7 = 0) at Week 12||11.78|2.83|< 0.001
71883949|NCT05032157|143287532|SUPERIORITY||Odds Ratio (OR)|7.92|||<|0.001|TWO_SIDED|95.0|3.72|16.85|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|Early onset of disease activity control (UAS7 =\< 6) at Week 2||16.85|3.72|< 0.001
71883950|NCT05032157|143287533|SUPERIORITY||Odds Ratio (OR)|2.75|||<|0.001|TWO_SIDED|95.0|1.65|4.58|||Regression, Logistic||Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|Dermatology Life Quality Index (DLQI) = 0-1 at Week 12||4.58|1.65|< 0.001
71883951|NCT05032157|143287534|SUPERIORITY||Rate ratio|3.26|||<|0.001|TWO_SIDED|95.0|2.26|4.71|||Regression, Linear||Negative binomial regression with log link includes treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics as covariates. A rate ratio \>1 favors LOU064 25 mg b.i.d.|Disease activity control (UAS7 =\< 6) up to Week 12||4.71|2.26|< 0.001
71883952|NCT05032157|143287535|SUPERIORITY||Rate ratio|1.32|||<|0.001|TWO_SIDED|95.0|1.17|1.49|||Regression, Linear||Negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates. A rate ratio \> 1 favors LOU064 25 mg b.i.d.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.49|1.17|< 0.001
71883953|NCT02049944|143287557|OTHER|we used t-test on the regression coefficient for the group indicator to test for differences in means categorical variables were evaluated using fisher's exact test of association linear regression for log transformed start adipose concentrations were calculated by dose specific group|Median Difference (Final Values)|80.0|||||TWO_SIDED|95.0|||||Fisher Exact|||To detect the number of subjects who obtained a minimal inhibitory concentration (\>4mg/ml) following increased 3g dose of cefazolin. Compare this number to the historical cohort who had received 2g of cefazolin (standard dosing)||||
71883954|NCT01765673|143287562|OTHER|||||||0.218|||||||paired t test|||||||0.218
71883955|NCT01765673|143287563|OTHER|||||||0.017|||||||paired t test|||||||0.017
71883956|NCT01765673|143287564|OTHER|||||||0.022|||||||paired t test|||||||0.022
71883957|NCT01765673|143287565|OTHER|||||||0.719|||||||paired t test|||||||0.719
71883958|NCT01765673|143287566|OTHER|||||||0.418|||||||paired t test|||||||0.418
71883959|NCT01765673|143287567|OTHER|||||||0.038|||||||paired t test|||||||0.038
71883960|NCT01765673|143287568|OTHER|||||||0.086|||||||paired t test|||||||0.086
71883961|NCT01765673|143287569|OTHER|||||||0.16|||||||paired t test|||||||0.16
71883962|NCT01765673|143287570|OTHER|||||||0.052|||||||paired t test|||||||0.052
71883963|NCT01765673|143287571|OTHER|||||||0.827|||||||paired t test|||||||0.827
71883964|NCT01765673|143287572|OTHER|||||||0.088|||||||paired t test|||||||0.088
71883965|NCT01765673|143287573|OTHER|||||||0.152|||||||paired t test|||||||0.152
71883966|NCT01765673|143287574|OTHER|||||||0.229|||||||paired t test|||||||0.229
71883967|NCT01765673|143287575|OTHER|||||||0.121|||||||paired t test|||||||0.121
71700423|NCT01013753|142916432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.095|STANDARD_ERROR_OF_MEAN|0.498|<|0.0001||95.0|-3.073|-1.116|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-1.116|-3.073|<0.0001
71883968|NCT01765673|143287576|OTHER|||||||0.239|||||||paired t test|||||||0.239
71883969|NCT01765673|143287577|OTHER|||||||0.03|||||||paired t test|||||||0.03
71700424|NCT01013753|142916432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|0.503||0.0003||95.0|-2.824|-0.849|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.849|-2.824|0.0003
71883970|NCT01765673|143287578|OTHER|||||||0.067|||||||paired t test|||||||0.067
71883971|NCT01765673|143287579|OTHER|||||||0.396|||||||paired t test|||||||0.396
71883972|NCT01765673|143287580|OTHER|||||||0.373|||||||paired t test|||||||0.373
71883973|NCT01765673|143287581|OTHER|||||||0.744|||||||paired t test|||||||0.744
71883974|NCT02600507|143287590|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.03||0.021|TWO_SIDED|95.0|-4.42|-0.37|||Mixed Effects Model for Repeated Measure|||||-0.37|-4.42|0.021
71883975|NCT02600507|143287590|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.01||0.099|TWO_SIDED|95.0|-3.65|0.32|||Mixed Effects Model for Repeated Measure|||||0.32|-3.65|0.099
71883976|NCT02600507|143287591|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.008|TWO_SIDED|95.0|-0.59|-0.09|||Mixed Effects Model for Repeated Measure|||||-0.09|-0.59|0.008
71883977|NCT02600507|143287591|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.04|TWO_SIDED|95.0|-0.5|-0.01|||Mixed Effects Model for Repeated Measure|||||-0.01|-0.50|0.040
71883978|NCT00621504|143287617|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.|Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-0.2|12.6|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.||12.6|-0.2|
71883979|NCT03257267|143287642|SUPERIORITY||Hazard Ratio (HR)|0.665|||<|1e-05|TWO_SIDED|95.0|0.555|0.796||One-sided p-value|Stratified Log-rank Test|||||0.796|0.555|<0.00001
71700425|NCT01013753|142916432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.789|STANDARD_ERROR_OF_MEAN|0.506||0.0004||95.0|-2.783|-0.795|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.795|-2.783|0.0004
71883980|NCT03257267|143287643|SUPERIORITY||Hazard Ratio (HR)|0.741||||0.00031|TWO_SIDED|95.0|0.623|0.882|||Stratified Log-rank Test|||||0.882|0.623|0.00031
71883981|NCT03257267|143287644|SUPERIORITY||Odds Ratio (OR)|3.136||||2e-05|TWO_SIDED|95.0|1.798|5.468|||Stratified Cochran-Mantel-Haenszel test|||||5.468|1.798|0.00002
71883982|NCT03257267|143287649|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.00024|TWO_SIDED|95.0|0.57|0.855||One-sided p-value|Stratified Log-rank Test|||||0.855|0.570|0.00024
71883983|NCT01979523|143287650|OTHER|||||||0.74|||||||Log Rank|||||||0.74
71883984|NCT03657368|143287658|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.042|TWO_SIDED|97.5|-0.4|7.3|||Regression, Linear|||||7.3|-0.4|0.042
71883985|NCT03657368|143287658|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|97.5|-3.9|3.7|||Regression, Linear|||||3.7|-3.9|0.966
71883986|NCT03657368|143287659|SUPERIORITY||Odds Ratio (OR)|0.93||||0.519|TWO_SIDED|99.2|0.68|1.27|||Regression, Logistic|||||1.27|0.68|0.519
71883987|NCT03657368|143287659|SUPERIORITY||Odds Ratio (OR)|0.87||||0.232|TWO_SIDED|99.2|0.63|1.19|||Regression, Logistic|||||1.19|0.63|0.232
71883988|NCT03657368|143287660|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.217|TWO_SIDED|99.2|-6.5|2.4|||Regression, Linear|||||2.4|-6.5|0.217
71883989|NCT03657368|143287660|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.66|TWO_SIDED|99.2|-3.7|5.2|||Regression, Linear|||||5.2|-3.7|0.660
71883990|NCT03657368|143287661|SUPERIORITY||mean ratio|1.03||||0.143|TWO_SIDED|99.2|0.97|1.1|||Mixed Models Analysis|||||1.10|0.97|0.143
71883991|NCT03657368|143287661|SUPERIORITY||mean ratio|0.99||||0.649|TWO_SIDED|99.2|0.93|1.05|||Regression, Logistic|||||1.05|0.93|0.649
71883992|NCT01623271|143287664|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71883993|NCT01982292|143287671|SUPERIORITY_OR_OTHER||Difference in percentage|0.5|||>|0.9999|TWO_SIDED|90.0|-9.38|10.38|||Fisher Exact|||Difference in percentage of patients with positive antibody status||10.38|-9.38|>0.9999
71883994|NCT01982292|143287671|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5|||||TWO_SIDED|90.0|-10.38|9.38||||||Difference in percentage of patients with negative antibody status||9.38|-10.38|
71883995|NCT01008280|143287704|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.||||<0.01
71883996|NCT01008280|143287704|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.||||>0.01
71883997|NCT01008280|143287704|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.||||>0.01
71883998|NCT01008280|143287705|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.||||<0.01
71883999|NCT01008280|143287705|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.||||>0.01
71884000|NCT01008280|143287705|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.||||>0.01
71884001|NCT01008280|143287706|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.||||<0.01
71884002|NCT01008280|143287706|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.||||>0.01
71884003|NCT01008280|143287706|SUPERIORITY_OR_OTHER||||||>|0.01|TWO_SIDED|95.0|||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.||||>0.01
71884004|NCT01968460|143287707|SUPERIORITY||Mean Difference (Net)|-4.67|STANDARD_ERROR_OF_MEAN|1.28||0.0004|TWO_SIDED|95.0|-7.2|-2.13||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-2.13|-7.20|0.0004
71884005|NCT01968460|143287707|SUPERIORITY||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|1.25||0.0027|TWO_SIDED|95.0|-6.32|-1.36||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-1.36|-6.32|0.0027
71884006|NCT01968460|143287708|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.51||0.0004|TWO_SIDED|95.0|-2.86|-0.84||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.84|-2.86|0.0004
71884007|NCT01968460|143287708|SUPERIORITY||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|0.01||0.005|TWO_SIDED|95.0|-2.41|0.44||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||0.44|-2.41|0.005
71700426|NCT01013753|142916432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.503||0.0118||95.0|-2.258|-0.283|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.283|-2.258|0.0118
71884008|NCT01968460|143287709|SUPERIORITY||Odds Ratio (OR)|8.1||||0.0165|TWO_SIDED|95.0|1.47|44.77||The overall significance level for this study was 5% using two-tailed tests.|Regression, Logistic|||A subject will be defined as a treatment responder in case that the improvement from baseline to the Week12 / Last Observed Value (LOV) in the CGI-S will be of 1 point or more. Baseline adjusted logistic regression (SAS® LOGISTIC procedure) stratified by GeoSite using the STRATA sub-command with the following effects: treatment group and baseline CGI-S measurement was used to test the between the active groups and placebo contrasts.||44.77|1.47|0.0165
71884009|NCT01968460|143287709|SUPERIORITY||Odds Ratio (OR)|4.23|STANDARD_ERROR_OF_MEAN|0.9||0.111|TWO_SIDED|95.0|0.72|24.9||The overall significance level for this study will be 5% using two-tailed tests.|Regression, Logistic|||||24.90|0.72|0.111
71884010|NCT01968460|143287710|SUPERIORITY||Mean Difference (Net)|-2.81|STANDARD_ERROR_OF_MEAN|1.0||0.0058|TWO_SIDED|95.0|-4.8|-0.83||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.83|-4.80|0.0058
71943967|NCT02728102|143410131|SUPERIORITY|||||||0.5353||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 6 months Post Transplant.||||0.5353
71943968|NCT02728102|143410131|SUPERIORITY|||||||0.4417||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 12 months Post Transplant.||||0.4417
71700427|NCT01013753|142916433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.025||0.0002||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.141|0.045|0.0002
71884011|NCT01968460|143287710|SUPERIORITY||Mean Difference (Net)|-2.32|STANDARD_ERROR_OF_MEAN|0.98||0.0191|TWO_SIDED|95.0|-4.26|-0.39||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|MMRM|||||-0.39|-4.26|0.0191
71884012|NCT01968460|143287711|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.24||0.0097|TWO_SIDED|95.0|-5.72|-0.8||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.80|-5.72|0.0097
71884013|NCT01968460|143287711|SUPERIORITY||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|1.24||0.0509|TWO_SIDED|95.0|-4.91|-0.012||The overall significance level for this study will be 5% using two-tailed tests utilizing the hierarchical gate keeping approach to control the overall Type-I error rate in the strong sense.|Mixed Models Analysis|||||-0.012|-4.91|0.0509
71884014|NCT01780831|143287720|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
71884015|NCT01780831|143287720|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|31.0|||||TWO_SIDED|90.0|18.7|46.6||||||||46.6|18.7|
71884016|NCT01780831|143287727|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|25.0|||||TWO_SIDED|90.0|9.0|48.4||||||||48.4|9|
71884017|NCT01780831|143287727|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had grade 3/4 AE through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|43.0|||||TWO_SIDED|90.0|28.6|58.1||||||||58.1|28.6|
71884018|NCT01780831|143287728|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
71884019|NCT01780831|143287728|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 6 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
71884020|NCT01780831|143287729|OTHER|Point and 90% CI estimates of percentage Cohort 1 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|6.0|||||TWO_SIDED|90.0|0.3|26.4||||||||26.4|0.3|
71943969|NCT02728102|143410131|SUPERIORITY|||||||0.945||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||Proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine and the combined non-vaccine arms at 24 months Post Transplant.||||0.9450
71943970|NCT02728102|143410131|SUPERIORITY|||||||0.1599||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide/GM-CSF arm is conducted at 1 year post transplant.||||0.1599
71884021|NCT01780831|143287729|OTHER|Point and 90% CI estimates of percentage Cohort 2 infants who died or had SADR of Grade 3 or 4 through 24 weeks of life.|Clopper-Pearson Confidence Interval (CI)|0.0|||||TWO_SIDED||||||||CI is not provided since the estimation parameter is 0.|||||
71943971|NCT02728102|143410131|SUPERIORITY|||||||0.8984||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between the vaccine arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.8984
71884022|NCT01780831|143287730|OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
71884023|NCT01780831|143287731|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71884024|NCT01780831|143287732|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
71884025|NCT02264990|143287739|SUPERIORITY|A fixed sequence testing procedure was used for analyses of the primary and secondary efficacy endpoints to control for the familywise error rate. If veliparib plus C/P treatment was not statistically significantly better compared to the investigators' choice of standard therapy for the primary efficacy endpoint of OS in LSP+ participants, then statistical significance would not be declared for any of the secondary efficacy endpoints.|Hazard Ratio (HR)|0.644||||0.113|TWO_SIDED|95.0|0.396|1.048||Statistical significance was determined by a two-sided P value ≤ 0.05.|Log Rank|Log rank test stratified by ECOG performance status, investigators' preferred platinum therapy, and gender.|Hazard ratio obtained using the covariate adjusted Cox Proportional Hazard Model with covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.048|0.396|0.113
71884026|NCT02264990|143287740|OTHER||Hazard Ratio (HR)|0.647||||0.26|TWO_SIDED|95.0|0.388|1.08|||Log Rank|Log-rank test stratified by investigator's preferred platinum therapy, gender, and ECOG performance status.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.080|0.388|0.260
71884027|NCT02264990|143287741|OTHER||Odds Ratio (OR)|0.66||||0.455|TWO_SIDED|95.0|0.23|1.9|||Regression, Logistic|Logistic regression adjusted for the covariates of ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.90|0.23|0.455
71884028|NCT02264990|143287742|OTHER||Hazard Ratio (HR)|0.986||||0.846|TWO_SIDED|95.0|0.827|1.176|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.176|0.827|0.846
71884029|NCT02264990|143287743|OTHER||Hazard Ratio (HR)|1.035||||0.473|TWO_SIDED|95.0|0.867|1.235|||Log Rank|Log rank test stratified by LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|The hazard ratio was obtained using the covariate adjusted Cox Proportional Hazard Model with covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.235|0.867|0.473
71884030|NCT02264990|143287744|OTHER||Odds Ratio (OR)|0.86||||0.409|TWO_SIDED|95.0|0.59|1.24|||Regression, Logistic|Logistic regression adjusted for the covariates of LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|Odds ratio is from covariate adjusted logistic regression with the covariates being LSP status, ECOG performance status, investigators' preferred platinum therapy, and gender.|||1.24|0.59|0.409
71884031|NCT00267748|143287746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.089||||0.86|TWO_SIDED|95.0|0.423|2.803|||Log Rank|||For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.803|0.423|0.860
71884032|NCT00267748|143287746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.583|TWO_SIDED|95.0|0.623|1.306|||Log Rank|||For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.306|0.623|0.583
71884033|NCT00267748|143287746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.556||||0.075|TWO_SIDED|95.0|0.288|1.074|||Log Rank|||For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.074|0.288|0.075
71884034|NCT00267748|143287746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.22|TWO_SIDED|95.0|0.609|1.124|||Log Rank|||For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.124|0.609|0.220
71884035|NCT00267748|143287746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.09|TWO_SIDED|95.0|0.572|1.044|||Log Rank|||For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.||1.044|0.572|0.090
71884036|NCT00267748|143287747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.11||||0.444|TWO_SIDED|95.0|-6.4|14.6|||Chi-squared|||Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.||14.6|-6.4|0.444
71884037|NCT00267748|143287749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.071||||0.866|TWO_SIDED|95.0|0.481|2.387|||Log Rank|||For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.387|0.481|0.866
71884038|NCT00267748|143287749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.169||||0.439|TWO_SIDED|95.0|0.785|1.741|||Log Rank|||For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.741|0.785|0.439
71700428|NCT01013753|142916433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.081|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.081|<0.0001
71700429|NCT01013753|142916433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.087|<0.0001
71700430|NCT01013753|142916433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.121|0.217|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.217|0.121|<0.0001
71884039|NCT00267748|143287749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.238||||0.614|TWO_SIDED|95.0|0.538|2.851|||Log Rank|||For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||2.851|0.538|0.614
71700431|NCT01013753|142916433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.024||0.0001||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.141|0.045|0.0001
71884040|NCT00267748|143287749|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.365|TWO_SIDED|95.0|0.838|1.612|||Log Rank|||For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.||1.612|0.838|0.365
71884041|NCT00267748|143287750|SUPERIORITY_OR_OTHER|||||||0.6737|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.6737
71884042|NCT00267748|143287751|SUPERIORITY_OR_OTHER|||||||0.1967|TWO_SIDED||||||t-test, 2 sided|||P value was calculated using sample t-test.||||0.1967
71884043|NCT01294800|143287752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7||||0.0564|TWO_SIDED|95.0|-1.37|0.02|||Constrained longitudinal data analysis|||||0.02|-1.37|0.0564
71884044|NCT01294800|143287752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.1844|TWO_SIDED|95.0|-1.16|0.22|||Constrained longitudinal data analysis|||||0.22|-1.16|0.1844
71884045|NCT01294800|143287752|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.3||||0.3386|TWO_SIDED|95.0|-1.04|0.36|||Constrained longitudinal data analysis|||||0.36|-1.04|0.3386
71884046|NCT01294800|143287753|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.404|TWO_SIDED|95.0|-7.75|19.0|||A generalized linear mixed model|||||19.00|-7.75|0.404
71884047|NCT01294800|143287753|SUPERIORITY_OR_OTHER||Difference in proportions of responders|5.7||||0.39|TWO_SIDED|95.0|-7.73|18.81|||A generalized linear mixed model|||||18.81|-7.73|0.390
71884048|NCT01294800|143287753|SUPERIORITY_OR_OTHER||Difference in proportions of responders|-4.9||||0.508|TWO_SIDED|95.0|-17.78|7.97|||A generalized linear mixed model|||||7.97|-17.78|0.508
71884049|NCT01294800|143287754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.7||||0.0509|TWO_SIDED|95.0|0.0|1.43|||Constrained longitudinal data analysis|||||1.43|-0.00|0.0509
71884050|NCT01294800|143287754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.1847|TWO_SIDED|95.0|-0.23|1.19|||Constrained longitudinal data analysis|||||1.19|-0.23|0.1847
71884051|NCT01294800|143287754|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.5||||0.2021|TWO_SIDED|95.0|-0.25|1.19|||Constrained longitudinal data analysis|||||1.19|-0.25|0.2021
71884052|NCT00797732|143287768|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||.17
71884053|NCT02275338|143287783|OTHER|||||||0.0055||||||The expected proportion of responders using Lanreotide was 50%, 1 sided test, 2.5% significance level alpha and power of 80% using Z-test for binomial proportion.|Binomial test|||One sided binomial test to compare percentage of responding subjects to theoretical proportion of 30%.||||0.0055
71884054|NCT01827670|143287796|SUPERIORITY_OR_OTHER||Adjusted Mean|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.53|-1.06|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-1.06|-1.53|<0.0001
71884055|NCT01827670|143287797|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||ANCOVA|From ANCOVA model: Treatment as fixed factor \& baseline Schiff score as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-0.62|-1.00|<0.0001
71943972|NCT02728102|143410131|SUPERIORITY|||||||0.1757||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||A pairwise analysis of proportion of participants achieving CR among the subset of participants who are not in CR at the time of randomization between lenalidomide/GM-CSF arm and lenalidomide alone arm is conducted at 1 year post transplant.||||0.1757
71943973|NCT02728102|143410132|SUPERIORITY|||||||0.161||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between vaccine vs. non- vaccine arms.||||0.161
71884056|NCT01827670|143287798|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.4|35.1|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||35.1|19.4|<0.0001
71884057|NCT01827670|143287799|SUPERIORITY_OR_OTHER||Adjusted Mean|7.5||||0.0138|TWO_SIDED|95.0|1.6|13.4|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||13.4|1.6|0.0138
71884058|NCT01827670|143287800|SUPERIORITY_OR_OTHER||Adjusted Mean|-12.14||||0.0003|TWO_SIDED|95.0|-18.51|-5.77|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"||-5.77|-18.51|0.0003
71884059|NCT01827670|143287801|SUPERIORITY_OR_OTHER||Adjusted Mean|-21.82|||<|0.0001|TWO_SIDED|95.0|-29.55|-14.09|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments."||-14.09|-29.55|<0.0001
71884060|NCT00689572|143287804|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|-0.09||||0.972|TWO_SIDED|95.0|-5.43|5.25|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)||5.25|-5.43|0.972
71884061|NCT00689572|143287805|EQUIVALENCE|Mixed-effects linear regression model|Mean Difference (Final Values)|0.44||||0.909|TWO_SIDED|95.0|-7.08|7.95|||Regression, Linear|Mixed-effects linear regression model included random intercept and slope (for temporal trend)||Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)||7.95|-7.08|0.909
71943974|NCT02728102|143410133|SUPERIORITY|||||||0.116||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide/GM-CSF arm.||||0.116
71943975|NCT02728102|143410133|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the vaccine arm and lenalidomide alone arm.||||0.519
71943976|NCT02728102|143410133|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Myeloma Progression between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
71943977|NCT02728102|143410135|SUPERIORITY|||||||0.168||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between vaccine vs. non- vaccine arms.||||0.168
71884062|NCT03603496|143287820|SUPERIORITY||Risk Ratio (RR)|1.18||||0.19|TWO_SIDED|95.0|0.92|1.5|||Chi-squared||Comparing TTCM as numerator, QL as denominator (reference group)|Two-stage multiple imputation techniques were used to estimate the missing smoking outcomes. 1st stage: we imputed missing data from surveys. 2nd stage: we imputed missing data from biochemical sample collection. Null hypothesis was no difference between arms in biochemically-validated past 7-day abstinence from cigarettes and other conventional tobacco products at 6-months. Sample of 1350 (675/group) was planned to detect a 6.5% difference (23.0% vs. 16.5%) with 84% power and 2-sided p\<0.05.||1.50|0.92|.19
71884063|NCT03603496|143287821|SUPERIORITY||Risk Ratio (RR)|1.22||||0.002|TWO_SIDED|95.0|1.08|1.35|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.35|1.08|.002
71884064|NCT03603496|143287822|SUPERIORITY||Risk Ratio (RR)|1.23||||0.001|TWO_SIDED|95.0|1.09|1.37|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.37|1.09|.001
71884065|NCT03603496|143287823|SUPERIORITY||Risk Ratio (RR)|1.13||||0.079|TWO_SIDED|95.0|0.98|1.29|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.29|0.98|.079
71884066|NCT03603496|143287824|SUPERIORITY||Risk Ratio (RR)|1.32|||<|0.0001|TWO_SIDED|95.0|1.21|1.44|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.44|1.21|<.0001
71884067|NCT03603496|143287825|SUPERIORITY||Risk Ratio (RR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.23|1.5|||Chi-squared|||Participants lost to follow-up or with missing data are counted as having received no treatment. The null hypothesis was no difference between study arms.||1.50|1.23|<.0001
71884068|NCT03603496|143287826|SUPERIORITY||Risk Ratio (RR)|1.31||||0.033|TWO_SIDED|95.0|1.02|1.66|||Chi-squared||Numerator is TTCM, denominator (reference group) is QL|Multiple imputation techniques were used to estimate the missing smoking outcomes. The null hypothesis was no difference between study arms.||1.66|1.02|.033
71884069|NCT00684788|143287891|SUPERIORITY||Odds Ratio (OR)|5.68|||=|0.008|TWO_SIDED|95.0|1.61|20.02|||General Estimating Equation (GEE)|||||20.02|1.61|=0.008
71884070|NCT00684788|143287892|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||||||0.0033
71700432|NCT01013753|142916434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0362||95.0|0.003|0.097|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.097|0.003|0.0362
71884071|NCT00684788|143287895|SUPERIORITY||Odds Ratio (OR)|1.05||||0.939|TWO_SIDED|95.0|0.32|3.42|||General Estimating Equation (GEE)|||||3.42|0.32|0.939
71943978|NCT02728102|143410136|SUPERIORITY|||||||0.12||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.120
71884072|NCT00684788|143287897|SUPERIORITY||Odds Ratio (OR)|1.074||||0.959|TWO_SIDED|95.0|0.071|16.245|||General Estimating Equation (GEE)|||||16.245|0.071|0.959
71884073|NCT00623428|143287898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4557|TWO_SIDED|95.0|0.45|1.43|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|"The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.~(second column)."|In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.||1.43|0.45|0.4557
71884074|NCT00623428|143287899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0788|TWO_SIDED|95.0|0.33|1.06|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.06|0.33|0.0788
71884075|NCT00623428|143287900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.5654|TWO_SIDED|95.0|0.48|3.87|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||3.87|0.48|0.5654
71884076|NCT00623428|143287902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
71884077|NCT00623428|143287903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.1934|TWO_SIDED|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.|||1.21|0.38|0.1934
71884078|NCT00784654|143287942|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||< 0.001
71884079|NCT00784654|143287943|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71884080|NCT00784654|143287944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.4|-9.8|||ANCOVA|||||-9.8|-15.4|<0.001
71884081|NCT00784654|143287947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71884082|NCT00784654|143287951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
71884083|NCT00784654|143287952|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|||<|0.001|TWO_SIDED|95.0|3.5|9.5|||ANCOVA|||||9.5|3.5|<0.001
71884084|NCT00784654|143287953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 1 sided|||||||<0.001
71884085|NCT00784654|143287954|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA|||||-0.11|-0.26|<0.001
71884086|NCT00784654|143287957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Cochran-Mantel-Haenszel|||||||0.726
71884087|NCT04249687|143287960|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
71884088|NCT04249687|143287961|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
71884089|NCT01180660|143287962|SUPERIORITY_OR_OTHER||Median Difference (Net)|19.0||||0.01|TWO_SIDED|95.0|3.0|27.0|||Regression, Linear|||A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.||27|3|.01
71884090|NCT00262873|143287966|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71884091|NCT00262873|143287967|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71884092|NCT00262873|143287968|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71884093|NCT00844753|143287972|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
71884094|NCT00844753|143287973|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Chi-squared|||||||0.95
71884095|NCT04036968|143287980|SUPERIORITY|Comparison of three drug conditions with cannabidiol to control groups placebo+placebo and hydromorphone+placebo||||||0.195|||||||ANOVA|||||||0.195
71884096|NCT04036968|143287981|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71700433|NCT01013753|142916434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.023||0.0006||95.0|0.035|0.127|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.127|0.035|0.0006
71884097|NCT04036968|143287982|SUPERIORITY|||||||0.074|||||||ANOVA|||||||0.074
71943979|NCT02728102|143410136|SUPERIORITY|||||||0.519||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the vaccine arm and lenalidomide alone arm.||||0.519
71884098|NCT01314716|143287994|SUPERIORITY_OR_OTHER||Differences in least squares mean|4.6||||0.011|TWO_SIDED|95.0|1.1|8.2||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||8.2|1.1|0.011
71884099|NCT01314716|143287995|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.1||||0.56|TWO_SIDED|95.0|-2.7|5.0||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.0|-2.7|0.56
71884100|NCT05048719|143288029|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||||-0.40|-1.13|<0.001
71884101|NCT05048719|143288029|SUPERIORITY||LS Mean Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-1.85|-1.12|||Mixed Models Analysis|||||-1.12|-1.85|<0.001
71884102|NCT05048719|143288029|SUPERIORITY||LS Mean Difference|-1.36|||<|0.001|TWO_SIDED|95.0|-1.75|-0.98|||Mixed Models Analysis|||||-0.98|-1.75|<0.001
71884103|NCT05048719|143288029|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-1.96|-1.25|||Mixed Models Analysis|||||-1.25|-1.96|<0.001
71884104|NCT05048719|143288029|SUPERIORITY||LS Mean Difference|-1.67|||<|0.001|TWO_SIDED|95.0|-2.02|-1.32|||Mixed Models Analysis|||||-1.32|-2.02|<0.001
71884105|NCT05048719|143288030|SUPERIORITY||LS Mean Difference|-0.09||||0.626|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Analysis|||||0.28|-0.47|0.626
71884106|NCT05048719|143288030|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.18|-0.44|||Mixed Models Analysis|||||-0.44|-1.18|<0.001
71884107|NCT05048719|143288030|SUPERIORITY||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-1.08|-0.3|||Mixed Models Analysis|||||-0.30|-1.08|<0.001
71884108|NCT05048719|143288030|SUPERIORITY||LS Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||Mixed Models Analysis|||||-0.57|-1.29|<0.001
71884109|NCT05048719|143288030|SUPERIORITY||LS Mean Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.36|-0.64|||Mixed Models Analysis|||||-0.64|-1.36|<0.001
71884110|NCT05048719|143288031|OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|2.21|20.75|||Regression, Logistic|||||20.75|2.21|<0.001
71884111|NCT05048719|143288031|OTHER||Odds Ratio (OR)|34.09|||<|0.001|TWO_SIDED|95.0|9.92|117.16|||Regression, Logistic|||||117.16|9.92|<0.001
71884112|NCT05048719|143288031|OTHER||Odds Ratio (OR)|48.33|||<|0.001|TWO_SIDED|95.0|11.9|196.24|||Regression, Logistic|||||196.24|11.90|<0.001
71884113|NCT05048719|143288031|OTHER||Odds Ratio (OR)|45.72|||<|0.001|TWO_SIDED|95.0|13.61|153.64|||Regression, Logistic|||||153.64|13.61|<0.001
71884114|NCT05048719|143288031|OTHER||Odds Ratio (OR)|77.23|||<|0.001|TWO_SIDED|95.0|20.26|294.48|||Regression, Logistic|||||294.48|20.26|<0.001
71884115|NCT05048719|143288031|OTHER||Odds Ratio (OR)|1.22||||0.678|TWO_SIDED|95.0|0.48|3.13|||Regression, Logistic|||||3.13|0.48|0.678
71884116|NCT05048719|143288031|OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.19|17.24|||Regression, Logistic|||||17.24|2.19|<0.001
71884117|NCT05048719|143288031|OTHER||Odds Ratio (OR)|8.71|||<|0.001|TWO_SIDED|95.0|2.55|29.79|||Regression, Logistic|||||29.79|2.55|<0.001
71884118|NCT05048719|143288031|OTHER||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|3.05|22.3|||Regression, Logistic|||||22.30|3.05|<0.001
71884119|NCT05048719|143288031|OTHER||Odds Ratio (OR)|13.93|||<|0.001|TWO_SIDED|95.0|4.51|43.01|||Regression, Logistic|||||43.01|4.51|<0.001
71884120|NCT05048719|143288032|OTHER||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|2.93|22.9|||Regression, Logistic|||||22.90|2.93|<0.001
71884121|NCT05048719|143288032|OTHER||Odds Ratio (OR)|25.02|||<|0.001|TWO_SIDED|95.0|7.57|82.69|||Regression, Logistic|||||82.69|7.57|<0.001
71884122|NCT05048719|143288032|OTHER||Odds Ratio (OR)|62.31|||<|0.001|TWO_SIDED|95.0|12.26|316.63|||Regression, Logistic|||||316.63|12.26|<0.001
71884123|NCT05048719|143288032|OTHER||Odds Ratio (OR)|67.57|||<|0.001|TWO_SIDED|95.0|17.56|259.97|||Regression, Logistic|||||259.97|17.56|<0.001
71884124|NCT05048719|143288032|OTHER||Odds Ratio (OR)|129.55|||<|0.001|TWO_SIDED|95.0|26.72|628.09|||Regression, Logistic|||||628.09|26.72|<0.001
71884125|NCT05048719|143288032|OTHER||Odds Ratio (OR)|1.13||||0.802|TWO_SIDED|95.0|0.43|2.96|||Regression, Logistic|||||2.96|0.43|0.802
71884126|NCT05048719|143288032|OTHER||Odds Ratio (OR)|3.46||||0.026|TWO_SIDED|95.0|1.16|10.31|||Regression, Logistic|||||10.31|1.16|0.026
71884127|NCT05048719|143288032|OTHER||Odds Ratio (OR)|8.61||||0.006|TWO_SIDED|95.0|1.83|40.51|||Regression, Logistic|||||40.51|1.83|0.006
71943980|NCT02728102|143410136|SUPERIORITY|||||||0.387||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of Progression-Free Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.387
71884128|NCT05048719|143288032|OTHER||Odds Ratio (OR)|9.34|||<|0.001|TWO_SIDED|95.0|2.67|32.71|||Regression, Logistic|||||32.71|2.67|<0.001
71884129|NCT05048719|143288032|OTHER||Odds Ratio (OR)|17.9|||<|0.001|TWO_SIDED|95.0|4.02|79.7|||Regression, Logistic|||||79.70|4.02|<0.001
71884130|NCT05048719|143288033|OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-32.7|-10.3|||Mixed Models Analysis|||||-10.3|-32.7|<0.001
71884131|NCT05048719|143288033|OTHER||LS Mean Difference|-42.5|||<|0.001|TWO_SIDED|95.0|-53.4|-31.7|||Mixed Models Analysis|||||-31.7|-53.4|<0.001
71884132|NCT05048719|143288033|OTHER||LS Mean Difference|-41.0|||<|0.001|TWO_SIDED|95.0|-52.7|-29.3|||Mixed Models Analysis|||||-29.3|-52.7|<0.001
71884133|NCT05048719|143288033|OTHER||LS Mean Difference|-42.7|||<|0.001|TWO_SIDED|95.0|-53.5|-32.0|||Mixed Models Analysis|||||-32.0|-53.5|<0.001
71884134|NCT05048719|143288033|OTHER||LS Mean Difference|-44.7|||<|0.001|TWO_SIDED|95.0|-55.3|-34.2|||Mixed Models Analysis|||||-34.2|-55.3|<0.001
71884135|NCT05048719|143288033|OTHER||LS Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|-10.6|11.8|||Mixed Models Analysis|||||11.8|-10.6|<0.001
71884136|NCT05048719|143288033|OTHER||LS Mean Difference|-20.5|||<|0.001|TWO_SIDED|95.0|-31.4|-9.5|||Mixed Models Analysis|||||-9.5|-31.4|<0.001
71884137|NCT05048719|143288033|OTHER||LS Mean Difference|-19.0||||0.002|TWO_SIDED|95.0|-30.7|-7.2|||Mixed Models Analysis|||||-7.2|-30.7|0.002
71884138|NCT05048719|143288033|OTHER||LS Mean Difference|-20.7|||<|0.001|TWO_SIDED|95.0|-31.4|-9.9|||Mixed Models Analysis|||||-9.9|-31.4|<0.001
71943981|NCT02728102|143410137|SUPERIORITY|||||||0.563||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between vaccine vs. non- vaccine arms.||||0.563
71738813|NCT01363908|142990425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6875|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.6875
71738814|NCT01363908|142990425|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to \<12 year olds at 48 weeks||||1.0000
71884139|NCT05048719|143288033|OTHER||LS Mean Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-33.2|-12.1|||Mixed Models Analysis|||||-12.1|-33.2|<0.001
71884140|NCT05048719|143288034|OTHER||LS Mean Difference|-1.6||||0.153|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||||0.6|-3.7|0.153
71884141|NCT05048719|143288034|OTHER||LS Mean Difference|-4.3|||<|0.001|TWO_SIDED|95.0|-6.4|-2.2|||Mixed Models Analysis|||||-2.2|-6.4|<0.001
71884142|NCT05048719|143288034|OTHER||LS Mean Difference|-7.6|||<|0.001|TWO_SIDED|95.0|-9.8|-5.3|||Mixed Models Analysis|||||-5.3|-9.8|<0.001
71884143|NCT05048719|143288034|OTHER||LS Mean Difference|-7.4|||<|0.001|TWO_SIDED|95.0|-9.4|-5.3|||Mixed Models Analysis|||||-5.3|-9.4|<0.001
71884144|NCT05048719|143288034|OTHER||LS Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.9|-5.9|||Mixed Models Analysis|||||-5.9|-9.9|<0.001
71884145|NCT05048719|143288034|OTHER||LS Mean Difference|0.1||||0.914|TWO_SIDED|95.0|-2.0|2.3|||Mixed Models Analysis|||||2.3|-2.0|0.914
71884146|NCT05048719|143288034|OTHER||LS Mean Difference|-2.6||||0.015|TWO_SIDED|95.0|-4.7|-0.5|||Mixed Models Analysis|||||-0.5|-4.7|0.015
71884147|NCT05048719|143288034|OTHER||LS Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.1|-3.6|||Mixed Models Analysis|||||-3.6|-8.1|<0.001
71884148|NCT05048719|143288034|OTHER||LS Mean Difference|-5.7|||<|0.001|TWO_SIDED|95.0|-7.8|-3.6|||Mixed Models Analysis|||||-3.6|-7.8|<0.001
71884149|NCT05048719|143288034|OTHER||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-8.3|-4.2|||Mixed Models Analysis|||||-4.2|-8.3|<0.001
71884150|NCT02229552|143288052|OTHER|Repeated measures analysis of variance with zbmi for each year as the repeated dependent measure.|Mean Difference (Final Values)|3.0||||0.051|TWO_SIDED||||||ANOVA|||||||0.051
71884151|NCT04872101|143288053|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.8|28.5||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||28.5|15.8|<0.001
71884152|NCT04872101|143288054|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|16.0|29.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.8|16.0|<0.001
71884153|NCT04872101|143288055|SUPERIORITY||Risk Difference (RD)|6.5||||0.043|TWO_SIDED|95.0|0.8|12.3||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.3|0.8|0.043
71884154|NCT04872101|143288056|SUPERIORITY||Risk Difference (RD)|27.4|||<|0.001|TWO_SIDED|95.0|19.0|35.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.8|19.0|<0.001
71943982|NCT02728102|143410138|SUPERIORITY|||||||0.308||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide/GM-CSF arm.||||0.308
71943983|NCT02728102|143410138|SUPERIORITY|||||||0.99||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the vaccine arm and lenalidomide alone arm.||||0.990
71884155|NCT04872101|143288057|SUPERIORITY||Risk Difference (RD)|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.2||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.2|15.1|<0.001
71884156|NCT04872101|143288058|SUPERIORITY||Risk Difference (RD)|29.0|||<|0.001|TWO_SIDED|95.0|21.3|36.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||36.7|21.3|<0.001
71884157|NCT04872101|143288059|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|11.0|25.6||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||25.6|11.0|<0.001
71884158|NCT04872101|143288060|SUPERIORITY||Risk Difference (RD)|6.6||||0.031|TWO_SIDED|95.0|1.1|12.0||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||12.0|1.1|0.031
71884159|NCT04872101|143288061|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|17.5|32.5||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.5|17.5|<0.001
71884160|NCT04872101|143288062|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.001|TWO_SIDED|95.0|10.2|23.7||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||23.7|10.2|<0.001
71884161|NCT04872101|143288063|SUPERIORITY||Risk Difference (RD)|26.0|||<|0.001|TWO_SIDED|95.0|17.0|35.1||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.1|17.0|<0.001
71890341|NCT03219164|143302187|NON_INFERIORITY|Non-inferiority of the 14-day treatment regimen was claimed if the lower bound of 1-sided 97.5% confidence limit of the treatment difference (14-day course group vs 28-day course group) was above the noninferiority margin of -20%.|Difference in percentage|-8.0|||||TWO_SIDED|95.0|-24.6|8.6|||||The difference in percentage between treatment groups, and the associated 95% CIs were constructed based on stratum-adjusted Mantel-Haenszel method using age as stratification factor.|||8.6|-24.6|
71890342|NCT03219164|143302189|OTHER||||||||||||||||||The historical pooled data from published results for the percentage of participants with successful PA eradication at 28 days post-treatment with TNS was estimated to be 77%.|||
71943984|NCT02728102|143410138|SUPERIORITY|||||||0.303||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference of overall Survival between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.303
71822613|NCT04529538|143147916|OTHER||GMT Ratio|1.98|||||TWO_SIDED|95.0|0.603|6.528|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 1 neutralizing antibody GMT at Day 57||6.528|0.603|
71822614|NCT04529538|143147917|OTHER||GMT Ratio|1.56|||||TWO_SIDED|95.0|0.639|3.828|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||3.828|0.639|
71890343|NCT02689492|143302193|OTHER||Intercept|68.5027|STANDARD_DEVIATION|8.0355|||||||||||Standard deviation is actually standard error.|||||
71890344|NCT02689492|143302194|OTHER||Intercept|95.4051|STANDARD_DEVIATION|6.9951|||||||||||Standard deviation is actually standard error.|||||
71890345|NCT02689492|143302195|OTHER||Intercept|74.8895|STANDARD_DEVIATION|8.0048|||||||||||Standard deviation is actually standard error.|||||
71890346|NCT02338843|143302242|SUPERIORITY||Odds Ratio (OR)|7.95|||<|0.001|TWO_SIDED|95.0|4.76|13.3|||Regression, Logistic|Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.||||13.3|4.76|<0.001
71822615|NCT04529538|143147918|OTHER||GMT Ratio|1.79|||||TWO_SIDED|95.0|0.772|4.163|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 29||4.163|0.772|
71822616|NCT04529538|143147918|OTHER||GMT Ratio|2.51|||||TWO_SIDED|95.0|0.994|6.34|||||GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.|Comparison of type 3 neutralizing antibody GMT at Day 57||6.340|0.994|
71822617|NCT04529538|143147919|OTHER||Rate Difference|-4.0|||>|0.999|TWO_SIDED|95.0|-27.67|22.72|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-Group Seroconversion Rate (4-fold rise) in Neutralizing Antibody Titers||22.72|-27.67|>0.999
71822618|NCT04529538|143147920|OTHER||Rate Difference|-2.8|||>|0.999|TWO_SIDED|95.0|-20.47|20.86|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||20.86|-20.47|>0.999
71822619|NCT04529538|143147920|OTHER||Rate Difference|8.3||||0.263|TWO_SIDED|95.0|-5.71|30.57|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||30.57|-5.71|0.263
71822620|NCT04529538|143147921|OTHER||Rate Difference|14.3||||0.224|TWO_SIDED|95.0|-8.3|40.45|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after vaccination||40.45|-8.30|0.224
71822621|NCT04529538|143147922|OTHER||Rate Difference|9.8||||0.275|TWO_SIDED|95.0|-7.29|35.19|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.||35.19|-7.29|0.275
71822622|NCT04529538|143147922|OTHER||Rate Difference|17.9||||0.1|TWO_SIDED|95.0|-1.27|44.93|||Fisher Exact||Rate Difference = nOPV - mOPV|Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.||44.93|-1.27|0.100
71822623|NCT00235495|143147942|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.1||The generalized linear model with log link function is tested at the one-sided alpha level of 0.025.|Regression, Logistic|Adjustment is made for baseline NIHSS and Thrombolysis stratum.|Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.|Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).||1.10|0.84|
71822624|NCT00235495|143147943|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.8|1.09|||Regression, Logistic|||||1.09|0.80|
71822625|NCT00235495|143147944|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.66|1.49|||Regression, Logistic|||||1.49|0.66|
71822626|NCT00235495|143147945|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||||TWO_SIDED|99.0|0.71|1.1|||Regression, Logistic|||||1.10|0.71|
71822627|NCT00235495|143147946|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03|||||TWO_SIDED|99.0|0.82|1.28|||Regression, Logistic|||||1.28|0.82|
71822628|NCT00235495|143147947|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.85|1.13|||Regression, Logistic|||||1.13|0.85|
71884162|NCT04872101|143288064|SUPERIORITY||Risk Difference (RD)|29.6|||<|0.001|TWO_SIDED|95.0|21.7|37.4||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||37.4|21.7|<0.001
71822629|NCT00235495|143147948|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98|||||TWO_SIDED|99.0|0.87|1.11|||Regression, Logistic|||||1.11|0.87|
71822630|NCT00235495|143147949|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95|||||TWO_SIDED|99.0|0.83|1.1|||Regression, Logistic|||||1.10|0.83|
71822631|NCT00235495|143147950|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.99|||||TWO_SIDED|99.0|0.84|1.17|||Regression, Logistic|||||1.17|0.84|
71822632|NCT00235495|143147951|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|||||TWO_SIDED|99.0|0.84|1.02|||Regression, Logistic|||||1.02|0.84|
71822633|NCT00235495|143147952|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|73098.0||||0.913||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.913
71822634|NCT00235495|143147953|SUPERIORITY_OR_OTHER_LEGACY||Rank Sum|44853.5||||0.923||95.0|||||Wilcoxon rank sum test, normal approx|||||||0.923
71822635|NCT00235495|143147954|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.79|1.76|||Regression, Logistic|||||1.76|0.79|
71822636|NCT00235495|143147955|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.47|2.15|||Regression, Logistic|||||2.15|0.47|
71822637|NCT00235495|143147956|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.39|3.41|||Regression, Logistic|||||3.41|0.39|
71822638|NCT00235495|143147957|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.69|||||TWO_SIDED|95.0|0.98|2.94|||Regression, Logistic|||||2.94|0.98|
71822639|NCT00235495|143147958|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|10.8|||||TWO_SIDED|95.0|4.37|26.72|||Regression, Logistic|||||26.72|4.37|
71822640|NCT00235495|143147959|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.58|||||TWO_SIDED|95.0|1.09|6.12|||Regression, Logistic|||||6.12|1.09|
71822641|NCT00235495|143147960|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.42|||||TWO_SIDED|95.0|1.02|5.78|||Regression, Logistic|||||5.78|1.02|
71884163|NCT04872101|143288065|SUPERIORITY||Risk Difference (RD)|20.5|||<|0.001|TWO_SIDED|95.0|13.1|27.8||Evaluated at a 5% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.8|13.1|<0.001
71890347|NCT03155997|143302269|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.00957|TWO_SIDED|95.0|0.598|0.932|||Log Rank|Stratified by Interactive Web Response Systems (IWRS) Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.932|0.598|0.00957
71890348|NCT03155997|143302271|SUPERIORITY||Hazard Ratio (HR)|0.717|||||TWO_SIDED|95.0|0.559|0.92|||||Stratified by IWRS Geographical Region, IWRS Prior Treatment, IWRS Menopausal Status|||0.920|0.559|
71822642|NCT00235495|143147961|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.68|2.01|||Regression, Logistic|||||2.01|0.68|
71822643|NCT00235495|143147962|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.61|||Regression, Logistic|||||1.61|0.68|
71822644|NCT00235495|143147963|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.63|||Regression, Logistic|||||1.63|0.74|
71822645|NCT03298815|143147992|SUPERIORITY|||||||0.375|||||||McNemar|||||||0.375
71822646|NCT03298815|143147993|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
71822647|NCT03298815|143147994|SUPERIORITY|||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
71822648|NCT03298815|143147995|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
71884164|NCT04872101|143288066|SUPERIORITY||Risk Difference (RD)|22.2|||<|0.001|TWO_SIDED|95.0|15.4|29.0||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.0|15.4|<0.001
71890349|NCT01355289|143302301|SUPERIORITY_OR_OTHER||Difference in % of Responders|31.62||||0.0236|TWO_SIDED|95.0|5.39|57.84|||Cochran-Mantel-Haenszel|||||57.84|5.39|0.0236
71822649|NCT03298815|143147996|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
71822650|NCT03298815|143147997|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.00
71822651|NCT03298815|143147998|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
71822652|NCT03298815|143147999|SUPERIORITY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
71822653|NCT03298815|143148000|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71822654|NCT03298815|143148001|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
71822655|NCT03298815|143148002|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
71822656|NCT03298815|143148003|SUPERIORITY|||||||0.594||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.594
71822657|NCT03298815|143148003|SUPERIORITY|||||||0.469||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||0.469
71822658|NCT03298815|143148003|SUPERIORITY|||||||0.75||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.750
71822659|NCT03298815|143148004|SUPERIORITY|||||||0.063||||||30 day visit|Wilcoxon (Mann-Whitney)|||||||0.063
71822660|NCT03298815|143148004|SUPERIORITY||||||<|1||||||60 day visit|Wilcoxon (Mann-Whitney)|||||||<1.000
71822661|NCT03298815|143148004|SUPERIORITY|||||||0.25||||||100 day visit|Wilcoxon (Mann-Whitney)|||||||0.250
71822662|NCT04060680|143148006|SUPERIORITY|The pre-specified Objective Performance Criterion (OPC) for the major complication free rate at 6 months is 0.79. If the lower confidence bound of two-sided 95% confidence interval for the freedom from the first major EV ICD System/procedure-related complication through 182 days post implant exceeds 0.79, the primary safety objective will be met. The freedom from the first major EV ICD System/procedure-related complication was estimated using the Kaplan-Meier method.|Major complication-free rate|92.6|||<|0.0001|TWO_SIDED|95.0|89.0|95.0||A priori threshold for statistical significance is 0.025|Kaplan-Meier method|||The primary safety objective is to demonstrate the freedom from major complications related to the EV ICD System and/or procedure at 6 months post-implant exceeds an OPC of 79%. H0: p ≤ 0.79 HA: p \> 0.79, where p denotes the 6-month (182 days) freedom from major EV ICD System/procedure-related complications rate.||95.0|89.0|<0.0001
71822663|NCT04060680|143148007|SUPERIORITY|The pre-specified OPC for the EV ICD defibrillation testing success at implant is 0.88. If the lower confidence bound of two-sided 95% confidence interval for the proportion of EV ICD patients achieving defibrillation testing success at implant exceeds 0.88, the primary efficacy objective will be met. The primary efficacy objective will be evaluated using a one-proportion binomial exact test along with a two-sided 95% Clopper-Pearson confidence bound.|Proportion|98.7|||<|0.0001|TWO_SIDED|95.0|96.6|99.6||A priori threshold for statistical significance is 0.025|One-proportion binomial exact test|||The primary efficacy is to demonstrate the EV ICD defibrillation testing success rate at implant is greater than an OPC of 88%. H0: p ≤ 0.88 HA: p \> 0.88, where p denotes the probability of EV ICD defibrillation success at implant.||99.6|96.6|<0.0001
71822664|NCT02322775|143148008|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.08||||0.04|TWO_SIDED|95.0|0.0|0.15||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||The null hypothesis was: H0: Change from baseline in pre-bronchodilator FEV1 (L) at Week 12 (benralizumab vs placebo)=0.||0.15|0|0.040
71822665|NCT02322775|143148009|SUPERIORITY_OR_OTHER||Difference of Least Square Means|8.84||||0.233|TWO_SIDED|95.0|-5.74|23.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||23.42|-5.74|0.233
71822666|NCT02322775|143148010|SUPERIORITY_OR_OTHER||Difference of Least Square Means|5.29||||0.456|TWO_SIDED|95.0|-8.67|19.25||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||19.25|-8.67|0.456
71822667|NCT02322775|143148011|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.13||||0.266|TWO_SIDED|95.0|-0.35|0.1||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.10|-0.35|0.266
71822668|NCT02322775|143148012|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36||||0.2|TWO_SIDED|95.0|-0.91|0.19||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.19|-0.91|0.200
71822669|NCT02322775|143148013|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.03||||0.38|TWO_SIDED|95.0|-0.08|0.03||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.03|-0.08|0.380
71890350|NCT01355289|143302301|SUPERIORITY_OR_OTHER||Difference in % of Responders|60.78||||0.0003|TWO_SIDED|95.0|36.3|85.27|||Cochran-Mantel-Haenszel|||||85.27|36.30|0.0003
71890351|NCT01355289|143302301|SUPERIORITY_OR_OTHER||Difference in % of Responders|58.4||||0.0003|TWO_SIDED|95.0|30.92|85.88|||Cochran-Mantel-Haenszel|||||85.88|30.92|0.0003
71890352|NCT00813995|143302313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparison|ANCOVA|||||||<.001
71890353|NCT02507349|143302318|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Time-by-treatment interaction||||<0.0001
71822670|NCT02322775|143148014|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.17||||0.114|TWO_SIDED|95.0|-0.39|0.04||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||||0.04|-0.39|0.114
71884165|NCT04872101|143288067|SUPERIORITY||Risk Difference (RD)|31.3|||<|0.001|TWO_SIDED|95.0|23.1|39.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.5|23.1|<0.001
71884166|NCT04872101|143288068|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.7|39.3||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||39.3|22.7|<0.001
71700434|NCT01013753|142916434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.024||0.0002||95.0|0.042|0.135|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.135|0.042|0.0002
71700435|NCT01013753|142916434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.07|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.164|0.070|<0.0001
71884167|NCT04872101|143288069|SUPERIORITY||Mean Difference (Net)|-45.5|||<|0.001|TWO_SIDED|95.0|-56.4|-34.6||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-34.6|-56.4|<0.001
71884168|NCT04872101|143288070|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.8||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.8|-5.0|<0.001
71884169|NCT04872101|143288071|SUPERIORITY||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.4|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.4|<0.001
71884170|NCT04872101|143288072|SUPERIORITY||Median Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.4|-2.5|<0.001
71884171|NCT04872101|143288073|SUPERIORITY||Mean Difference (Net)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.5||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.5|-2.6|<0.001
71890354|NCT02507349|143302318|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49.||||0.0033
71890355|NCT02507349|143302318|SUPERIORITY|||||||0.3164|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.3164
71700436|NCT01013753|142916434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.024||0.001||95.0|0.032|0.125|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.125|0.032|0.0010
71822671|NCT02322775|143148016|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.21||||0.055|TWO_SIDED|95.0|0.0|0.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Total score||0.42|0|0.055
71822672|NCT02322775|143148016|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.23||||0.063|TWO_SIDED|95.0|-0.01|0.47||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Symptoms score||0.47|-0.01|0.063
71943985|NCT02728102|143410140|SUPERIORITY|||||||0.189||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients With Grade ≥ 3 Toxicities between vaccine vs. non- vaccine arms.||||0.189
71884172|NCT04872101|143288074|SUPERIORITY||Median Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-0.99|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-0.99|<0.001
71884173|NCT04872101|143288075|SUPERIORITY||Mean Difference (Net)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.01|-0.62||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.62|-1.01|<0.001
71884174|NCT04872101|143288076|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|17.0|35.9||Evaluated at a 1% significance level (two-sided) using hierarchical tests, alpha splitting, and alpha recycling to control overall type 1 error at 5% (two-sided)|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||35.9|17.0|<0.001
71884175|NCT03354663|143288082|OTHER|Single arm trial|Proportion|0.047|||<|0.0001|ONE_SIDED|95.0||0.0864|||Binomial Exact Test|||"The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P \< 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level."||0.0864||<0.0001
71884176|NCT03354663|143288083|OTHER|"The hypothesis is formally expressed as:~H0: P \< 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success."|Proportion|0.98||||0.0001|ONE_SIDED|95.0|0.9495||||Binomial Exact Test||||||0.9495|0.0001
71884177|NCT03354663|143288088|OTHER||Kaplan-Meier Survival Estimate|82.2|||||TWO_SIDED|95.0|74.7|87.6|||||Kaplan-Meier estimate of freedom from recurrence at 1-year|Kaplan Meier Estimate of freedom from recurrence.||87.6|74.7|
71884178|NCT03354663|143288089|OTHER||Kaplan-Meier survival estimate|68.2|||||TWO_SIDED|95.0|59.9|75.1||||||Kaplan-Meier estimate of freedom from recurrence or need for anti-arrhythmic medication||75.1|59.9|
71884179|NCT03691974|143288103|SUPERIORITY||Least Square (LS) Mean Difference|0.4||||0.4192|TWO_SIDED|95.0|-0.55|1.32||Analyses are based on Mixed Model for Repeated Measures (MMRM) model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|Mixed Model for Repeated Measures (MMRM)|||||1.32|-0.55|0.4192
71884180|NCT03691974|143288104|SUPERIORITY||LS Mean Difference|0.4||||0.0521|TWO_SIDED|95.0|0.0|0.8||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||0.80|-0.00|0.0521
71943986|NCT02728102|143410142|SUPERIORITY|||||||0.82||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between vaccine vs. non- vaccine arms.||||0.82
71943987|NCT02728102|143410143|SUPERIORITY|||||||0.21||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide/GM-CSF arm.||||0.21
71943988|NCT02728102|143410143|SUPERIORITY|||||||0.4||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the vaccine arm and lenalidomide alone arm.||||0.40
71943989|NCT02728102|143410143|SUPERIORITY|||||||0.08||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Participants with Grade 2 and 3 infections between the lenalidomide/GM-CSF arm and lenalidomide alone arm.||||0.08
71884181|NCT03691974|143288105|SUPERIORITY||LS Mean Difference|1.3||||0.1593|TWO_SIDED|95.0|-0.52|3.15||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||3.15|-0.52|0.1593
71884182|NCT03691974|143288106|SUPERIORITY||LS Mean Difference|-0.2||||0.7757|TWO_SIDED|95.0|-1.59|1.19||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.19|-1.59|0.7757
71884183|NCT03691974|143288107|SUPERIORITY||LS Mean Difference|-0.4||||0.6063|TWO_SIDED|95.0|-1.87|1.09||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.09|-1.87|0.6063
71884184|NCT03691974|143288108|SUPERIORITY||LS Mean Difference|-1.0||||0.4203|TWO_SIDED|95.0|-3.3|1.39||Analyses are based on MMRM model with terms for baseline nerve conduction test score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||1.39|-3.30|0.4203
71884185|NCT03691974|143288109|SUPERIORITY||LS Mean Difference|-1.33||||0.001|TWO_SIDED|95.0|-2.123|-0.538||Analyses are based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.538|-2.123|0.0010
71884186|NCT03691974|143288110|SUPERIORITY||LS Mean Difference|-1.42||||0.0005|TWO_SIDED|95.0|-2.212|-0.625||Analyses were based on multiple imputation with MMRM model with terms for baseline WOMAC subscale score, treatment, screening Kellgren-Lawrence score, index joint, visit, and treatment by visit interaction.|MMRM|||||-0.625|-2.212|0.0005
71884187|NCT00746252|143288120|OTHER|||||||0.495||||||Threshold of significance is p\<.05|t-test, 2 sided|||Comparison of mean weight gain between groups.||||.495
71884188|NCT03325673|143288138|SUPERIORITY|||||||0.116|||||||Independent t-test|||||||0.116
71884189|NCT03325673|143288139|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Insertion||||0.468
71884190|NCT03325673|143288139|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||After 2 hours||||0.235
71884191|NCT03325673|143288139|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||End of Day||||0.152
71884192|NCT03325673|143288140|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
71884193|NCT03325673|143288141|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
71943990|NCT02728102|143410144|SUPERIORITY|||||||0.8||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of proportions of patients without Minimal Residual Disease between vaccine vs. non- vaccine arms||||0.80
71943991|NCT02605395|143410184|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.|Ratio of means|95.71|||||TWO_SIDED|90.0|90.12|101.65||||||||101.65|90.12|
71943992|NCT02605395|143410185|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.|Ratio of means|96.5|||||TWO_SIDED|90.0|90.02|103.44||||||||103.44|90.02|
71943993|NCT02605395|143410186|EQUIVALENCE|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.|Ratio of means|95.69|||||TWO_SIDED|90.0|87.06|105.17||||||||105.17|87.06|
71884194|NCT00590590|143288142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||||||||||Ha: Drug 1 \< Drug 2||||
71884195|NCT00590590|143288142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
71884196|NCT00590590|143288142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 2 \< Placebo||||
71884197|NCT00590590|143288143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||||||||||||Ha: Drug 1 \< Drug 2||||
71884198|NCT00590590|143288143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 \< Placebo||||
71884199|NCT00590590|143288143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||||||||||||Ha: Drug 2 \< Placebo||||
71884200|NCT00590590|143288144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||||||||||||Ha: Drug 1 \< Drug 2||||
71884201|NCT00590590|143288144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||||||||||||Ha: Drug 1 \< Placebo||||
71884202|NCT00590590|143288144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8||||||||||||||Ha: Drug 2 \< Placebo||||
71884203|NCT00590590|143288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3||||||||||||||Ha: Drug 1 \< Drug 2||||
71884204|NCT00590590|143288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0||||||||||||||Ha: Drug 1 \< Placebo||||
71884205|NCT00590590|143288145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||||||||||||Ha: Drug 2 \< Placebo||||
71884206|NCT00590590|143288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||||||||||||Ha: Drug 1 \< Drug 2||||
71884207|NCT00590590|143288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||||||||||||Ha: Drug 1 \< Placebo||||
71884208|NCT00590590|143288146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||||||||||||Ha: Drug 2 \< Placebo||||
71884209|NCT00590590|143288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||||||||||Ha: Drug 1 \< Drug 2||||
71884210|NCT00590590|143288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||||||||||||Ha: Drug 1 \< Placebo||||
71884211|NCT00590590|143288147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||||||||||||Ha: Drug 2 \< Placebo||||
71884212|NCT01870401|143288154|NON_INFERIORITY|The protocol identified a non-inferiority bound equal to 0.12 (12%).|||||<|0.025|||||||Farrington and Manning|||The primary safety hypothesis is as follows: H0: pControl - pDCB ≥ and H1: pControl (alpha) pDCB \< where p is the success rate in each arm and (alpha) is the non-inferiority bound.||||<0.025
71884213|NCT01870401|143288155|SUPERIORITY|||||||0.0222|||||||Wald Test|One-sided Wald test based on model estimate of DCB treatment effect and subject as a random effect.||||||0.0222
71884214|NCT01602692|143288181|OTHER|||||||0.24|||||||ANOVA|||End of PACU Mean Pain Level p-value between arms||||0.24
71884215|NCT01602692|143288181|OTHER|||||||0.76|||||||ANOVA|||First 24 hrs Post-op Mean Current Pain p-value between arms||||0.76
71884216|NCT01602692|143288181|OTHER|||||||0.78|||||||ANOVA|||First 24 hrs Post-op Mean Worst Pain p-value between arms||||0.78
71884217|NCT01602692|143288181|OTHER|||||||0.41|||||||ANOVA|||First 24 hrs Post-op Mean Least Pain p-value between arms||||0.41
71884218|NCT01602692|143288182|OTHER|||||||0.1|||||||ANOVA|||PACU IV hydromorphone p-value between arms||||0.10
71884219|NCT01602692|143288182|OTHER|||||||0.71|||||||ANOVA|||First 24 hr Post-op oxycodone p-value between arms||||0.71
71884220|NCT00493870|143288205|OTHER|||||||0.05|||||||Log Rank|||||||0.05
71884221|NCT03605680|143288219|SUPERIORITY||Least Squares (LS ) Mean Difference|-3.15|||=|0.0193|TWO_SIDED|95.0|-5.79|-0.51|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.51|-5.79|=0.0193
71884222|NCT03605680|143288219|SUPERIORITY||LS Mean Difference|-2.74|||=|0.0392|TWO_SIDED|95.0|-5.35|-0.14|||MMRM|||||-0.14|-5.35|=0.0392
71884223|NCT03605680|143288220|SUPERIORITY||LS Mean Difference|-0.27|||=|0.0232|TWO_SIDED|95.0|-0.5|-0.04|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.04|-0.50|=0.0232
71943994|NCT01061866|143410209|NON_INFERIORITY_OR_EQUIVALENCE|p less than or equal to 0.05, repeated measures ANOVA|Mean Difference (Final Values)|0.02|||<|0.02||||||p-value is non-adjusted for multiple comparisons|ANOVA|Was adjusted the degrees of freedom for the averaged test of significance.|The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.|Power=0.02||||<0.02
71943995|NCT00834756|143410210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.0||||||90.0|87.96|104.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.78|87.96|
71884224|NCT03605680|143288220|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0162|TWO_SIDED|95.0|-0.51|-0.05|||MMRM||||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|-0.05|-0.51|=0.0162
71884225|NCT00883337|143288236|SUPERIORITY_OR_OTHER|||||||0.5953||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.~Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5953
71884226|NCT00883337|143288236|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||"Hochberg testing procedure:~* a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~* a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value \>0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and Rebif~* H2: No difference between Teriflunomide 7 mg and Rebif"||||0.5190
71884227|NCT00527605|143288243|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.23|||<|0.0001||95.0|-20.23|-8.22|||t-test, 2 sided||Dutasteride arm minus placebo arm.|||-8.22|-20.23|<0.0001
71884228|NCT01485627|143288317|SUPERIORITY||Adjusted mean difference in difference|0.34||||0.05|TWO_SIDED|95.0|0.06|0.62|||Mixed Models Analysis||Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase\*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.|The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding \[APPC\], Verona VR-CoDES, Prognostic and Treatment Choices \[PTCC\] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.||0.62|0.06|0.05
71884229|NCT01485627|143288318|SUPERIORITY|||||||0.214|||||||Mixed Models Analysis|||||||0.214
71884230|NCT01485627|143288319|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.56|0.37|||Mixed Models Analysis|||||0.37|-0.56|0.05
71884231|NCT01485627|143288321|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
71943996|NCT00834756|143410211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.63||||||90.0|92.34|105.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.35|92.34|
71943997|NCT00834756|143410212|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.37||||||90.0|93.95|107.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.21|93.95|
71884232|NCT01485627|143288322|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
71884233|NCT01849172|143288334|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71943998|NCT01472341|143410213|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||0.24
71884234|NCT02112370|143288350|SUPERIORITY_OR_OTHER|||||||0.008||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Swallowing difficulty||||0.008
71884235|NCT02112370|143288350|SUPERIORITY_OR_OTHER|||||||0.016||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Anterior neck pain||||0.016
71884236|NCT02112370|143288350|SUPERIORITY_OR_OTHER|||||||0.019||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Right chest pain||||0.019
71884237|NCT02112370|143288350|SUPERIORITY_OR_OTHER|||||||0.035||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Left chest pain||||0.035
71884238|NCT02112370|143288350|SUPERIORITY_OR_OTHER|||||||0.089||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Back pain||||0.089
71884239|NCT02112370|143288350|SUPERIORITY_OR_OTHER|||||||0.634||||||threshold p value for significance \< 0.05|t-test, 2 sided|||Posterior neck pain||||0.634
71884240|NCT00774345|143288366|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.276|TWO_SIDED|95.0|0.61|1.15||The p-value is based on a stratified log-rank test.|Log Rank||Based on the stratified cox proportional hazards model comparing the hazard functions associated with the treatment groups.|||1.15|0.61|0.276
71884241|NCT02342015|143288372|OTHER||||||<|0.05|||||||wilcoxon signed-rank test|||||||<0.05
71884242|NCT02342015|143288373|OTHER||||||<|0.05|||||||paired Student's t-test|||||||<0.05
71884243|NCT01692301|143288374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.66|STANDARD_ERROR_OF_MEAN|1.42||0.01|TWO_SIDED|95.0|-6.45|-0.87|||ANCOVA|||||-0.87|-6.45|0.010
71884244|NCT01142726|143288385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.55||0.01|TWO_SIDED|95.0|1.18|3.43|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Month 12|Power estimate assumed 2-sided alpha level of 5% and that 60% of abatacept (ABA)+methotrexate (MX) patients (pts) would be in DAS28-CRP remission at Month 12 compared with 38% of MX monotherapy pts. Also assumed that 48% of ABA monotherapy pts would be in DAS28-CRP remission at Month 12, yielding an expected treatment difference from MX of 10% in favor of ABA monotherapy; 116 pts randomized to ABA monotherapy would yield a half-length of the 95% CI around that 10% treatment difference of 13.5%.||3.43|1.18|0.010
71943999|NCT01472341|143410214|SUPERIORITY_OR_OTHER|||||||0.001|||||||Multivariate regression analysis|PI/I ratio was the response variable and other study parameters were independent variables.||||||0.001
71944000|NCT01472341|143410215|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.||||||<0.0001
71944001|NCT02819323|143410216|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
71944002|NCT02819323|143410216|NON_INFERIORITY|Non-inferiority margin = 10%||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
71944003|NCT02819323|143410216|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|||||||0.046
71944004|NCT02819323|143410216|SUPERIORITY|||||||0.089|||||||Cochran-Mantel-Haenszel|||||||0.089
71884245|NCT01142726|143288385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|STANDARD_ERROR_OF_MEAN|1.15||0.045|TWO_SIDED|95.0|1.02|6.18|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Months 12 and 18|Conditional on statistical significance of the 1st coprimary efficacy analysis (CEA), a sample of 116 patients per arm would provide 98% power for the 2nd CEA comparison of the percentage of patients in DAS28-CRP remission at Months 12 and 18 between the abatacept (ABA)+methotrexate (MTX) arm and the MTX monotherapy arm for intent-to treat population. This sample size calculation assumed 30% remission in the ABA+MTX arm and 8% in the monotherapy arm at Month 18 and a 2-sided alpha level of 5%.||6.18|1.02|0.045
71884246|NCT01142726|143288386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.55|1.57|||||At Month 12|||1.57|0.55|
71884247|NCT01142726|143288386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|0.81|5.14|||||At Months 12 and 18|||5.14|0.81|
71884248|NCT02109484|143288409|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0165|||||||Wilcoxon (Mann-Whitney)|||||||0.0165
71884249|NCT02109484|143288409|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||<0.0001
71884250|NCT02109484|143288409|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71884251|NCT02109484|143288410|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were peformed||||<0.0001
71884252|NCT02109484|143288410|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71944005|NCT00578552|143410227|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.77
71944006|NCT00578552|143410227|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||1.00
71884253|NCT02109484|143288410|EQUIVALENCE|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||||||0.0006
71884254|NCT02109484|143288411|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Group B 10 mcg P2-VP8 was performed.||||0.0004
71884255|NCT02109484|143288411|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Cohort B 30 mcg P2-VP8 vaccine group was performed.||||<0.0001
71890356|NCT02507349|143302318|SUPERIORITY|||||||0.0482|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.0482
71890357|NCT02507349|143302318|SUPERIORITY|||||||0.9928|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.9928
71890358|NCT02507349|143302319|SUPERIORITY|||||||0.6243|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.6243
71890359|NCT02507349|143302319|SUPERIORITY|||||||0.1969|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.1969
71890360|NCT02507349|143302319|SUPERIORITY|||||||0.0042|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if \<=35; 1 if (35\<age\<=49); 2 if age \>49||||0.0042
71890361|NCT02507349|143302319|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.||||0.0002
71884256|NCT02109484|143288411|EQUIVALENCE|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide \>= 89% and \>= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide \> 95% to detect \>= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair-wise comparison between the Adjusted Seroresponses in Cohort B Placebo group and the Cohort B P2-VP8 group was performed.||||<0.0001
71884257|NCT02111993|143288415|SUPERIORITY_OR_OTHER|||||||0.02||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.02
71884258|NCT02111993|143288415|SUPERIORITY_OR_OTHER|||||||0.03||||||This p-value correlates to Δ8 hr cTnT.|t-test, 2 sided|||||||0.03
71884259|NCT02111993|143288415|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
71884260|NCT02111993|143288416|SUPERIORITY_OR_OTHER|||||||0.04||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.04
71884261|NCT02111993|143288416|SUPERIORITY_OR_OTHER|||||||0.06||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.06
71884262|NCT02111993|143288416|SUPERIORITY_OR_OTHER|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.16
71884263|NCT02111993|143288417|SUPERIORITY_OR_OTHER|||||||0.17||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided|||||||0.17
71944007|NCT02979353|143410239|SUPERIORITY||Risk Ratio (RR)|0.96||||0.017|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge timepoint (average 3 days after study enrollment)||||0.017
71944008|NCT02979353|143410239|SUPERIORITY||Risk Ratio (RR)|0.86|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the Post-Acute Care Discharge time point (occurred on average 31 days after study enrollment)||||<0.0001
71884264|NCT02111993|143288417|SUPERIORITY_OR_OTHER|||||||0.19||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided|||||||0.19
71884265|NCT02111993|143288417|SUPERIORITY_OR_OTHER|||||||0.38||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided|||||||0.38
71884266|NCT04074928|143288418|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.645|0.836||||||"Non-inferiority, A/H1N1, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H1N1 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.836|0.645|
71884267|NCT04074928|143288418|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.73|||||TWO_SIDED|95.0|0.656|0.809||||||"Non-inferiority, B/Yamagata, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Yamagata vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.809|0.656|
71884268|NCT04074928|143288418|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|0.88|||||TWO_SIDED|95.0|0.791|0.972||||||"Non-inferiority, B/Victoria, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the B/Victoria vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||0.972|0.791|
71884269|NCT04074928|143288419|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-11.46|||||TWO_SIDED|95.0|-16.447|-6.423||||||"Non-inferiority, A/H1N1, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H1N1 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-6.423|-16.447|
71884270|NCT04074928|143288419|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-14.87|||||TWO_SIDED|95.0|-19.61|-9.983||||||"Non-inferiority, B/Yamagata, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Yamagata vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-9.983|-19.610|
71944009|NCT02979353|143410239|SUPERIORITY||Risk Ratio (RR)|0.85|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up After PAC Discharge (occurred, on average, 122 days after study enrollment)||||<0.0001
71884271|NCT04074928|143288419|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|-5.96|||||TWO_SIDED|95.0|-10.327|-1.44||||||"Non-inferiority, B/Victoria, SCR difference, Day 29/57~Non-inferiority of the immune response to the B/Victoria vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||-1.440|-10.327|
71884272|NCT04074928|143288420|NON_INFERIORITY|The noninferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified noninferiority margin of 1.5 for the Day 29/57 GMT ratio (adjusted analysis).|GMT ratio|1.04|||||TWO_SIDED|95.0|0.927|1.16||||||"Non-inferiority, A/H3N2, GMT ratio, Day 29/57~Non-inferiority of the Day 29/57 immune response to the A/H3N2 vaccine strain calculated by GMT ratio (Comparator QIV GMT divided by QIVc GMT)"||1.160|0.927|
71884273|NCT04074928|143288421|NON_INFERIORITY|The non-inferiority criterion was that the upper limit of the 2-sided 95% CI did not exceed the prespecified non-inferiority margin of 10% for the Day 29/57 SCR difference.|SCR difference|3.13|||||TWO_SIDED|95.0|-1.443|7.812||||||"Non-inferiority, A/H3N2, SCR difference, Day 29/57~Non-inferiority of the immune response to the A/H3N2 vaccine strain by SCR difference (Comparator QIV SCR minus QIVc SCR)"||7.812|-1.443|
71884274|NCT04074928|143288422|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.024||||||A/H1N1, GMT ratio, Day 29/57||1.024|0.790|
71944010|NCT02979353|143410240|SUPERIORITY||Mean Difference (Net)|-0.28||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 1 applies to the Hospital Discharge time point (occurred, on average, 3 days after study enrollment)||||0.02
71944011|NCT02979353|143410240|SUPERIORITY||Mean Difference (Net)|-0.59|||<|1e-05|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 2 applies to Post-Acute Care Discharge time point (occurred, on average, 31 days after study enrollment).||||<0.00001
71944012|NCT02979353|143410240|SUPERIORITY||Mean Difference (Net)|-0.35||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||Statistical Analysis 3 applies to 90-Day Follow Up After PAC Discharge time point (occurred, on average, 122 after study enrollment).||||0.01
71884275|NCT04074928|143288422|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.08|||||TWO_SIDED|95.0|0.968|1.195||||||B/Yamagata, GMT ratio, Day 29/57||1.195|0.968|
71884276|NCT04074928|143288422|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.986|1.202||||||B/Victoria, GMT ratio, Day 29/57||1.202|0.986|
71884277|NCT04074928|143288423|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-2.52|||||TWO_SIDED|95.0|-7.526|2.461||||||A/H1N1, SCR difference, Day 29/57||2.461|-7.526|
71700437|NCT01013753|142916435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.77|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.282|-0.770|<0.0001
71884278|NCT04074928|143288423|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|-0.04|||||TWO_SIDED|95.0|-4.912|4.911||||||B/Yamagata, SCR difference, Day 29/57||4.911|-4.912|
71884279|NCT04074928|143288423|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.18|||||TWO_SIDED|95.0|-2.805|5.353||||||B/Victoria, SCR difference, Day 29/57||5.353|-2.805|
71884280|NCT04074928|143288424|OTHER|No formal statistical testing was planned for this secondary outcome measure.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.914|1.165||||||A/H3N2, GMT ratio, Day 29/57||1.165|0.914|
71884281|NCT04074928|143288425|OTHER|No formal statistical testing was planned for this secondary outcome measure.|SCR difference|1.89|||||TWO_SIDED|95.0|-3.006|6.856||||||A/H3N2, SCR difference, Day 29/57||6.856|-3.006|
71890362|NCT02507349|143302319|SUPERIORITY|||||||0.7254|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)||||0.7254
71890363|NCT02507349|143302319|SUPERIORITY|||||||0.058|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)||||0.0580
71890364|NCT02507349|143302320|SUPERIORITY|||||||0.4677|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.4677
71890365|NCT02507349|143302320|SUPERIORITY|||||||0.094|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0940
71890366|NCT02507349|143302321|SUPERIORITY|||||||0.8733|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.8733
71890367|NCT02507349|143302321|SUPERIORITY|||||||0.0113|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0113
71890368|NCT02507349|143302322|SUPERIORITY|||||||0.2328|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.2328
71890369|NCT02507349|143302322|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0005
71890370|NCT02507349|143302323|SUPERIORITY|||||||0.0033|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0033
71890371|NCT02507349|143302324|SUPERIORITY|||||||0.1649|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.1649
71890372|NCT02507349|143302324|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)||||0.0016
71890373|NCT02507349|143302325|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||Time-by-treatment interaction||||0.0080
71890374|NCT02507349|143302326|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71890375|NCT02507349|143302327|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71890376|NCT03618030|143302340|OTHER|||||||0.0003|||||||ANOVA|||The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom PERMP-T scores.||||.0003
71890377|NCT00473876|143302365|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.08||95.0|||||t-test, 1 sided|The differences between baseline and post-intervention (4 months) was analyzed using independent t-test, comparing metformin and placebo.||Null hypothesis: Metformin has no effect on peak VO2. We targetted 66 subjects and power calculation based on our previous observational study of CHF with insulin resistance with mean peak VO2 of 11.||||0.08
71890378|NCT00473876|143302366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.45|STANDARD_DEVIATION|10.72||0.034||95.0|||||t-test, 1 sided|Compare between metformin and placebo arm.||Null hypothesis: Metformin has no effect on the ratio between VCO2 (production of CO2) and VE (ventilation), it is also called the VE/VCO2 slope||||0.034
71890379|NCT00348140|143302367|SUPERIORITY||Mean Difference (Net)|0.3||||0.739|TWO_SIDED|95.0|-1.2|1.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.8|-1.2|0.739
71890380|NCT00348140|143302367|SUPERIORITY||Mean Difference (Net)|0.8||||0.343|TWO_SIDED|95.0|-0.8|2.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||2.4|-0.8|0.343
71890381|NCT00348140|143302368|SUPERIORITY||Mean Difference (Net)|-0.1||||0.783|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|0.783
71890382|NCT00348140|143302368|SUPERIORITY||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-1.1|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||1.1|-1.1|0.940
71890383|NCT00348140|143302369|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.763|TWO_SIDED|95.0|-1.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.8|-1.1|=0.763
71944013|NCT00617305|143410257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.93|STANDARD_DEVIATION|241.978|||TWO_SIDED|95.0|-337.7|-160.2||||||Mean change from Baseline to Week 24||-160.2|-337.7|
71944014|NCT00617305|143410257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
71944015|NCT00617305|143410257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-253.83|STANDARD_DEVIATION|235.787|||TWO_SIDED|95.0|-334.8|-172.8||||||Mean change from Baseline to Week 24||-172.8|-334.8|
71944016|NCT00617305|143410257|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-291.8|STANDARD_DEVIATION|205.864|||TWO_SIDED|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24||35.78|-619.4|
71944017|NCT00617305|143410258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.38|STANDARD_DEVIATION|7.954|||TWO_SIDED|95.0|-8.29|-2.46||||||Mean change from Baseline to Week 24||-2.46|-8.29|
71944018|NCT00617305|143410258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
71944019|NCT00617305|143410258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.56|STANDARD_DEVIATION|8.589|||TWO_SIDED|95.0|-9.51|-3.61||||||Mean change from Baseline to Week 24||-3.61|-9.51|
71944020|NCT00617305|143410258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.75|STANDARD_DEVIATION|8.732|||TWO_SIDED|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24||-1.86|-29.64|
71944021|NCT00617305|143410259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|4.442|||TWO_SIDED|95.0|-1.69|1.56||||||Mean change from Baseline to Week 24||1.56|-1.69|
71944022|NCT00617305|143410259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
71944023|NCT00617305|143410259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|4.527|||TWO_SIDED|95.0|-2.07|1.04||||||Mean change from Baseline to Week 24||1.04|-2.07|
71944024|NCT00617305|143410259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_DEVIATION|4.082|||TWO_SIDED|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24||2.50|-10.50|
71944025|NCT00617305|143410260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|STANDARD_DEVIATION|1.053|||TWO_SIDED|95.0|0.43|1.25||||||Mean change from Baseline to Week 24||1.25|0.43|
71944026|NCT00617305|143410260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
71944027|NCT00617305|143410260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_DEVIATION|1.021|||TWO_SIDED|95.0|0.41|1.15||||||Mean change from Baseline to Week 24||1.15|0.41|
71944028|NCT00617305|143410260|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.685|||TWO_SIDED|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24||1.42|-0.77|
71944029|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.2|STANDARD_DEVIATION|44.84|||TWO_SIDED|95.0|-3.9|28.4||||||Mean change from Baseline to Week 4 (LOCF)||28.4|-3.9|
71944030|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.8|STANDARD_DEVIATION|21.19|||TWO_SIDED|95.0|-26.0|41.5||||||Mean change from Baseline to Week 4 (LOCF)||41.5|-26.0|
71944031|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|107.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71944032|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.7|STANDARD_DEVIATION|42.68|||TWO_SIDED|95.0|-2.7|26.2||||||Mean change from Baseline to Week 4 (LOCF)||26.2|-2.7|
71944033|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.6|STANDARD_DEVIATION|48.03|||TWO_SIDED|95.0|-32.0|87.2||||||Mean change from Baseline to Week 4 (LOCF)||87.2|-32.0|
71738815|NCT01363908|142990425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8181|TWO_SIDED|||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.8181
71944034|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_DEVIATION|41.46|||TWO_SIDED|95.0|-1.4|28.5||||||Mean change from Baseline to Week 12 (LOCF)||28.5|-1.4|
71944035|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_DEVIATION|59.09|||TWO_SIDED|95.0|-91.5|96.5||||||Mean change from Baseline to Week 12 (LOCF)||96.5|-91.5|
71944036|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944037|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4|STANDARD_DEVIATION|42.83|||TWO_SIDED|95.0|-2.1|26.9||||||Mean change from Baseline to Week 12 (LOCF)||26.9|-2.1|
71944038|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.4|STANDARD_DEVIATION|63.61|||TWO_SIDED|95.0|-59.6|98.4||||||Mean change from Baseline to Week 12 (LOCF)||98.4|-59.6|
71944039|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1|STANDARD_DEVIATION|48.67|||TWO_SIDED|95.0|0.5|35.6||||||Mean change from Baseline to Week 24 (LOCF)||35.6|0.5|
71944040|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.5|STANDARD_DEVIATION|29.56|||TWO_SIDED|95.0|-56.5|37.5||||||Mean change from Baseline to Week 24 (LOCF)||37.5|-56.5|
71944041|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944042|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0|STANDARD_DEVIATION|47.44|||TWO_SIDED|95.0|-1.0|31.1||||||Mean change from Baseline to Week 24 (LOCF)||31.1|-1.0|
71944043|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.8|STANDARD_DEVIATION|50.18|||TWO_SIDED|95.0|-52.5|72.1||||||Mean change from Baseline to Week 24 (LOCF)||72.1|-52.5|
71944044|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|77.24|||TWO_SIDED|95.0|-25.6|30.1||||||Mean change from Baseline to Week 36 (LOCF)||30.1|-25.6|
71944045|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.0|STANDARD_DEVIATION|93.16|||TWO_SIDED|95.0|-182.2|114.2||||||Mean change from Baseline to Week 36 (LOCF)||114.2|-182.2|
71944046|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944047|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|78.5|||TWO_SIDED|95.0|-28.4|24.8||||||Mean change from Baseline to Week 36 (LOCF)||24.8|-28.4|
71944048|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8|STANDARD_DEVIATION|92.46|||TWO_SIDED|95.0|-128.6|101.0||||||Mean change from Baseline to Week 36 (LOCF)||101.0|-128.6|
71944049|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6|STANDARD_DEVIATION|82.07|||TWO_SIDED|95.0|-15.0|44.2||||||Mean change from Baseline to Week 48 (LOCF)||44.2|-15.0|
71944050|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.8|STANDARD_DEVIATION|126.75|||TWO_SIDED|95.0|-251.4|151.9||||||Mean change from Baseline to Week 48 (LOCF)||151.9|-251.4|
71944051|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|67.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944052|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.4|STANDARD_DEVIATION|88.11|||TWO_SIDED|95.0|-22.4|37.3||||||Mean change from Baseline to Week 48 (LOCF)||37.3|-22.4|
71944053|NCT00617305|143410261|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.4|STANDARD_DEVIATION|121.55|||TWO_SIDED|95.0|-177.3|124.5||||||Mean change from Baseline to Week 48 (LOCF)||124.5|-177.3|
71944054|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 4 (LOCF)||0.0|-1.1|
71944055|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|-1.6|3.1||||||Mean change from Baseline to Week 4 (LOCF)||3.1|-1.6|
71944056|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71944057|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.54|||TWO_SIDED|95.0|-0.9|0.1||||||Mean change from Baseline to Week 4 (LOCF)||0.1|-0.9|
71944058|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.52|||TWO_SIDED|95.0|-1.5|2.3||||||Mean change from Baseline to Week 4 (LOCF)||2.3|-1.5|
71944059|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.45|||TWO_SIDED|95.0|-1.1|0.0||||||Mean change from Baseline to Week 12 (LOCF)||0.0|-1.1|
71944060|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.38|||TWO_SIDED|95.0|-2.3|5.3||||||Mean change from Baseline to Week 12 (LOCF)||5.3|-2.3|
71944061|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944062|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.67|||TWO_SIDED|95.0|-0.9|0.2||||||Mean change from Baseline to Week 12 (LOCF)||0.2|-0.9|
71944063|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.17|||TWO_SIDED|95.0|-1.5|3.9||||||Mean change from Baseline to Week 12 (LOCF)||3.9|-1.5|
71944064|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|1.81|||TWO_SIDED|95.0|-1.5|-0.2||||||Mean change from Baseline to Week 24 (LOCF)||-0.2|-1.5|
71944065|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.75|||TWO_SIDED|95.0|-1.8|0.6||||||Mean change from Baseline to Week 24 (LOCF)||0.6|-1.8|
71944066|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944067|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.72|||TWO_SIDED|95.0|-1.4|-0.3||||||Mean change from Baseline to Week 24 (LOCF)||-0.3|-1.4|
71944068|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|0.71|||TWO_SIDED|95.0|-1.4|0.4||||||Mean change from Baseline to Week 24 (LOCF)||0.4|-1.4|
71944069|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.2|0.1||||||Mean change from Baseline to Week 36 (LOCF)||0.1|-1.2|
71944070|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|-2.2|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-2.2|
71944071|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944072|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.85|||TWO_SIDED|95.0|-1.0|0.2||||||Mean change from Baseline to Week 36 (LOCF)||0.2|-1.0|
71944073|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|1.79|||TWO_SIDED|95.0|-1.4|3.0||||||Mean change from Baseline to Week 36 (LOCF)||3.0|-1.4|
71944074|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|2.12|||TWO_SIDED|95.0|-1.4|0.1||||||Mean change from Baseline to Week 48 (LOCF)||0.1|-1.4|
71944075|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-4.5|6.5||||||Mean change from Baseline to Week 48 (LOCF)||6.5|-4.5|
71944076|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944077|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.3|||TWO_SIDED|95.0|-1.3|0.3||||||Mean change from Baseline to Week 48 (LOCF)||0.3|-1.3|
71944078|NCT00617305|143410262|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|3.03|||TWO_SIDED|95.0|-3.0|4.6||||||Mean change from Baseline to Week 48 (LOCF)||4.6|-3.0|
71944079|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|3.98|||TWO_SIDED|95.0|-2.7|0.4||||||Mean change from Baseline to Week 12 (LOCF)||0.4|-2.7|
71944080|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|4.86|||TWO_SIDED|95.0|-6.5|9.0||||||Mean change from Baseline to Week 12 (LOCF)||9.0|-6.5|
71944081|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944082|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.09|||TWO_SIDED|95.0|-2.3|0.6||||||Mean change from Baseline to Week 12 (LOCF)||0.6|-2.3|
71944083|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|4.45|||TWO_SIDED|95.0|-4.9|6.1||||||Mean change from Baseline to Week 12 (LOCF)||6.1|-4.9|
71944084|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|-2.7|1.1||||||Mean change from Baseline to Week 24 (LOCF)||1.1|-2.7|
71944085|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.03|||TWO_SIDED|95.0|-7.7|5.2||||||Mean change from Baseline to Week 24 (LOCF)||5.2|-7.7|
71944086|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944087|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|4.84|||TWO_SIDED|95.0|-2.6|0.9||||||Mean change from Baseline to Week 24 (LOCF)||0.9|-2.6|
71944088|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.51|||TWO_SIDED|95.0|-5.8|3.0||||||Mean change from Baseline to Week 24 (LOCF)||3.0|-5.8|
71944089|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.2|||TWO_SIDED|95.0|-2.3|1.7||||||Mean change from Baseline to Week 36 (LOCF)||1.7|-2.3|
71944090|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.65|||TWO_SIDED|95.0|-8.1|6.6||||||Mean change from Baseline to Week 36 (LOCF)||6.6|-8.1|
71944091|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944092|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|5.07|||TWO_SIDED|95.0|-2.2|1.5||||||Mean change from Baseline to Week 36 (LOCF)||1.5|-2.2|
71944093|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.02|||TWO_SIDED|95.0|-5.8|4.2||||||Mean change from Baseline to Week 36 (LOCF)||4.2|-5.8|
71944094|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.33|||TWO_SIDED|95.0|-2.8|2.1||||||Mean change from Baseline to Week 48 (LOCF)||2.1|-2.8|
71944095|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|6.86|||TWO_SIDED|95.0|-11.4|10.4||||||Mean change from Baseline to Week 48 (LOCF)||10.4|-11.4|
71944096|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944097|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|6.28|||TWO_SIDED|95.0|-2.7|1.9||||||Mean change from Baseline to Week 48 (LOCF)||1.9|-2.7|
71944098|NCT00617305|143410263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|5.94|||TWO_SIDED|95.0|-8.0|6.8||||||Mean change from Baseline to Week 48 (LOCF)||6.8|-8.0|
71944099|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71944100|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71944101|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.49||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71944102|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)||||
71944103|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.63||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944104|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944105|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.64||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944106|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)||||
71944107|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.83||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944108|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944109|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.81||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944110|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)||||
71944111|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.92||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944112|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944113|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944114|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)||||
71944115|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.91||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944116|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944117|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.88||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944118|NCT00617305|143410265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)||||
71944119|NCT03897088|143410271|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71944120|NCT03897088|143410280|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71944121|NCT03897088|143410281|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
71944122|NCT03897088|143410282|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71944123|NCT03897088|143410283|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71944124|NCT03897088|143410284|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
71944125|NCT03897088|143410285|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
71944126|NCT03897088|143410286|SUPERIORITY||||||<|1e-05||||||Log Rank Test p-Value|Kaplan-Meier Estimates|||||||<0.00001
71944127|NCT03897088|143410287|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||||||<0.00001
71944128|NCT03897088|143410288|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-75||||<0.00001
71944129|NCT03897088|143410288|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||PASI-90||||<0.00001
71944130|NCT03897088|143410288|SUPERIORITY|||||||4e-05|||||||Cochran-Mantel-Haenszel|||PASI-100||||0.00004
71944131|NCT03897088|143410289|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71944132|NCT03897088|143410290|SUPERIORITY||||||<|1e-05|||||||Mixed Models Analysis|||Week 16||||<0.00001
71944133|NCT03897088|143410291|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 16||||<0.00001
71944134|NCT03897088|143410292|SUPERIORITY||||||<|1e-05||||||Week 16|Cochran-Mantel-Haenszel|||||||<0.00001
71944135|NCT03897088|143410293|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
71944136|NCT03897088|143410294|SUPERIORITY||||||<|1e-05|||||||Cochran-Mantel-Haenszel|||Week 12||||<0.00001
71944137|NCT03555305|143410310|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.961|||||TWO_SIDED|90.0|0.886|1.04|||Linear mixed-effects model|||||1.04|0.886|
71944138|NCT03555305|143410311|EQUIVALENCE|Analysis was performed using linear mixed effects model and participant as a random effect, with period, sequence, and treatment as fixed effects. The estimate of the ratio of means of each PK/PD parameters between the 2 treatments and the corresponding 90% confidence interval were calculated. A typical bio-equivalence limit (0.8 to 1.25) was used as equivalence margin.|Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.874|1.02|||Linear mixed-effects model|||||1.02|0.874|
71944139|NCT00323193|143410338|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANOVA|||||||.720
71944140|NCT00323193|143410339|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||.710
71944141|NCT02100228|143410340|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.0||||0.0151|TWO_SIDED|95.0|0.0|0.6425||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||0.6425|0.0000|0.0151
71944142|NCT02100228|143410342|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.4905||||0.3378|TWO_SIDED|95.0|0.1046|2.0678||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||2.0678|0.1046|0.3378
71944143|NCT02100228|143410343|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.83||||0.6851|TWO_SIDED|95.0|0.3433|1.8916||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||1.8916|0.3433|0.6851
71944144|NCT02100228|143410344|SUPERIORITY|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|1.9841|||>|0.9999|TWO_SIDED|95.0|0.1866|53.9968||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.||53.9968|0.1866|>0.9999
71944145|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.91|0.60|0.005
71944146|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.78|TWO_SIDED|95.0|0.33|2.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||2.30|0.33|0.780
71944147|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.164|TWO_SIDED|95.0|0.75|5.33||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||5.33|0.75|0.164
71944148|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.919|TWO_SIDED|95.0|0.23|5.17||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model.||5.17|0.23|0.919
71944149|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.051|TWO_SIDED|95.0|1.0|3.3||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1.||3.30|1.00|0.051
71944150|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42||||0.076|TWO_SIDED|95.0|0.86|22.74||A priori threshold for statistical significance was p\<0.05|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1.||22.74|0.86|0.076
71944151|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.075|TWO_SIDED|95.0|0.13|1.1||A priori threshold fors tatistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||1.10|0.13|0.075
71944152|NCT00322465|143410376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.93|7.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1.||7.98|1.93|<0.001
71944153|NCT00322465|143410377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.009|TWO_SIDED|95.0|0.06|0.66||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||0.66|0.06|0.009
71944154|NCT00322465|143410377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.074|TWO_SIDED|95.0|0.92|6.22||A priori threshold for statistical signficance was p\<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.||6.22|0.92|0.074
71944155|NCT00322465|143410378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.032|TWO_SIDED|95.0|0.66|0.98||A priori threshold for statistical significance was p\<0.05.|Regression, Logistic|No other independent variables were included in the model.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.||0.98|0.66|0.032
71944156|NCT01073657|143410384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|STANDARD_DEVIATION|33.9||0.0059|TWO_SIDED|95.0|14.0|38.0|||t-test, 2 sided|||||38|14|0.0059
71944157|NCT01790581|143410385|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||MANOVA|||This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.||||.904
71944158|NCT01790581|143410387|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||MANOVA|||This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.||||.5
71944159|NCT00854100|143410390|SUPERIORITY||Least Squares Mean Difference|0.5||||0.746|TWO_SIDED|95.0|-2.4|3.4|||ANCOVA|||||3.4|-2.4|0.746
71944160|NCT00854100|143410390|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.227|TWO_SIDED|95.0|-4.8|1.1|||ANCOVA|||||1.1|-4.8|0.227
71944161|NCT00854100|143410391|SUPERIORITY||Least Squares Mean Difference|0.0||||0.918|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.918
71944162|NCT00854100|143410391|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.167|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.167
71944163|NCT00762307|143410435|OTHER||Mean Difference (Net)|18.7|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|14.9|22.4||||||||22.4|14.9|
71944164|NCT00762307|143410437|OTHER||sucess percentage|91.9|STANDARD_ERROR_OF_MEAN|5.2|||ONE_SIDED|||||||||||||
71944165|NCT01811953|143410484|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.55|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.531|105.653|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.653|99.531|<0.0001
71944166|NCT01811953|143410484|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.88|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.879|103.059|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.059|94.879|<0.0001
71944167|NCT01811953|143410484|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.0|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.728|109.386|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.386|102.728|<0.0001
71944168|NCT01811953|143410485|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|96.13|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.25|101.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.26|91.25|<0.0001
71944169|NCT01811953|143410485|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.34|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.56|106.62|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||106.62|92.56|<0.0001
71944170|NCT01811953|143410485|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean difference|100.81|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.74|106.14|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||106.14|95.74|<0.0001
71944171|NCT01811953|143410486|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.33|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|99.315|105.43|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||105.430|99.315|<0.0001
71944172|NCT01811953|143410486|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.82|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.784|103.037|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.037|94.784|<0.0001
71944173|NCT01811953|143410486|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|105.98|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|102.73|109.329|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.329|102.730|<0.0001
71944174|NCT01811953|143410487|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.12|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|96.255|108.351|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||108.351|96.255|<0.0001
71944175|NCT01811953|143410487|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.52|STANDARD_ERROR_OF_MEAN|1.063||0.0082|TWO_SIDED|90.0|95.863|118.353|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||118.353|95.863|0.0082
71944176|NCT01811953|143410487|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|104.352|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.152|110.224|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||110.224|99.152|<0.0001
71944177|NCT01811953|143410488|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.87|STANDARD_ERROR_OF_MEAN|1.038||0.0001|TWO_SIDED|90.0|88.931|101.21|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||101.210|88.931|0.0001
71944178|NCT01811953|143410488|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|97.97|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|92.339|103.935|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||103.935|92.339|<0.0001
71944179|NCT01811953|143410488|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.95|STANDARD_ERROR_OF_MEAN|1.034|<|0.0001|TWO_SIDED|90.0|97.166|109.082|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||109.082|97.166|<0.0001
71944180|NCT01811953|143410489|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.89|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|89.8|100.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.|||100.26|89.80|<0.0001
71944181|NCT01811953|143410489|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.31|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.14|107.03|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.|||107.03|92.14|<0.0001
71944182|NCT01811953|143410489|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|100.74|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|95.77|105.96|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.|||105.96|95.77|<0.0001
71822673|NCT02322775|143148016|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.2||||0.061|TWO_SIDED|95.0|-0.01|0.41||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Activity limitation score||0.41|-0.01|0.061
71822674|NCT02322775|143148016|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.156|TWO_SIDED|95.0|-0.07|0.45||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Emotional function score||0.45|-0.07|0.156
71822675|NCT02322775|143148016|SUPERIORITY_OR_OTHER||Difference of Least Square Means|0.19||||0.135|TWO_SIDED|95.0|-0.06|0.44||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Environmental stimuli score||0.44|-0.06|0.135
71944183|NCT01049334|143410495|SUPERIORITY_OR_OTHER||least-square means difference|-151.5||||0.0201|TWO_SIDED|95.0|-278.9|-24.0||The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.|ANOVA|Treatment as a fixed effect and baseline STPIS as a covariate.||||-24.0|-278.9|0.0201
71944184|NCT01049334|143410496|SUPERIORITY_OR_OTHER||least-square means difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-29.2|-9.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-9.9|-29.2|<.0001
71944185|NCT01049334|143410497|SUPERIORITY_OR_OTHER||least-square means difference|-22.3|||<|0.0001|TWO_SIDED|95.0|-31.7|-12.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-12.9|-31.7|<0.0001
71944186|NCT01049334|143410498|SUPERIORITY_OR_OTHER||least-square means difference|-181.7||||0.0071|TWO_SIDED|95.0|-313.7|-50.0||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-50.0|-313.7|0.0071
71944187|NCT01049334|143410499|SUPERIORITY_OR_OTHER||least-square means difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-30.2|-11.2||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-11.2|-30.2|<0.0001
71944188|NCT01049334|143410500|SUPERIORITY_OR_OTHER||least-square means difference|-137.6||||0.0393|TWO_SIDED|95.0|-268.5|-6.8||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate||||-6.8|-268.5|0.0393
71944189|NCT01049334|143410501|SUPERIORITY_OR_OTHER|||||||0.0459||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0459
71944190|NCT01049334|143410502|SUPERIORITY_OR_OTHER|||||||0.8383||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.8383
71944191|NCT01049334|143410503|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
71944192|NCT01049334|143410504|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0005
71944193|NCT01049334|143410505|SUPERIORITY_OR_OTHER|||||||0.0002||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||0.0002
71944194|NCT01049334|143410506|SUPERIORITY_OR_OTHER||least-square means difference|-156.3||||0.0435|TWO_SIDED|95.0|-307.9|-4.6||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|ANOVA|||||-4.6|-307.9|0.0435
71944195|NCT01049334|143410507|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value \>0.05 occurs.|Wilcoxon (Mann-Whitney)|||||||<.0001
71944196|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1448|TWO_SIDED|95.0|0.0|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 2||0.1|-0.0|0.1448
71944197|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.1538|TWO_SIDED|95.0|0.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 4||0.3|-0.0|0.1538
71944198|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.1407|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 6||0.5|-0.1|0.1407
71944199|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.2906|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 8||0.7|-0.2|0.2906
71944200|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.2||||0.4758|TWO_SIDED|95.0|-0.4|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 10||0.8|-0.4|0.4758
71944201|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.1||||0.6975|TWO_SIDED|95.0|-0.6|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 12||0.9|-0.6|0.6975
71944202|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|0.0||||0.937|TWO_SIDED|95.0|-0.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 14||0.9|-0.8|0.9370
71944203|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.8493|TWO_SIDED|95.0|-1.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 16||0.9|-1.1|0.8493
71944204|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-0.3||||0.6732|TWO_SIDED|95.0|-1.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 18||0.9|-1.4|0.6732
71944205|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-0.4||||0.5414|TWO_SIDED|95.0|-1.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 20||0.9|-1.8|0.5414
71944206|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-0.6||||0.4313|TWO_SIDED|95.0|-2.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 22||0.9|-2.1|0.4313
71944207|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-0.8||||0.3501|TWO_SIDED|95.0|-2.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 24||0.9|-2.4|0.3501
71822676|NCT01852162|143148019|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An analysis of covariance (ANCOVA) method with a general linear model, using the corresponding baseline PD value as a covariate, was used to evaluate the comparisons between dabigatran and placebo at 7 days.|ANCOVA|||Assuming a 20% relative difference in TRAP induced MPA between dabigatran and placebo with a common standard deviation of 10%, 13 patients with available data needed to be randomized to obtain a 95% power and 2-sided alpha=0.05.||||<0.05
71884282|NCT02685709|143288432|NON_INFERIORITY|An assessment of NI was made by comparing the lower bound of the two-sided 95% confidence interval (CI) for the difference in biochemical control (octreotide capsules - SRLs) to a NI margin of -20%.|95% CI Stratified Miettinen & Nurminen|-19.9|||||TWO_SIDED|95.0|-19.9|0.5|||Stratified Miettinen & Nurminen (M&N)|||||0.5|-19.9|
71884283|NCT02685709|143288433|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
71884284|NCT02685709|143288434|OTHER||||||||||||||Clopper-Pearson method|||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
71884285|NCT02685709|143288435|OTHER|||||||||||||Confidence interval was applied||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The statistical analysis was based on the stratified Miettinen \& Nurminen (M\&N) method.|||
71884286|NCT02685709|143288436|OTHER||||||||||||||Clopper-Pearson method|||Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.|Based on this analysis 63.0% of patients in the octreotide capsule group and 51.4% of patients in the SRL injection group entered the Study Extension phase.|||
71884287|NCT02685709|143288437|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|The mean change in IGF-1 from RCT Baseline to the end of the RCT phase was calculated using the Last Observation Carried Forward (LOCF) approach.|||
71884288|NCT02685709|143288438|OTHER|||||||||||||||||"Secondary endpoints were analyzed without adjustment for multiplicity or predefined noninferiority margins and therefore were interpreted as exploratory.~This endpoint is descriptive with no formal statistical hypothesis testing."|Estimates were obtained from an analysis of covariance (ANCOVA) for the mean integrated growth hormone (GH) change from baseline with explanatory factors of treatment group and baseline value.|||
71884289|NCT02685709|143288439|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing|The week 26 value was used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
71884290|NCT02685709|143288440|OTHER|||||||||||||||||This endpoint is descriptive with no formal statistical hypothesis testing.|The week 26 value is used as the baseline value for the RCT phase. The denominator for the percentage was the number of subjects at each visit.|||
71884291|NCT02685709|143288441|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing.|This sensitivity analysis was using the Full analysis set (FAS), where any patient who discontinued treatment early was imputed as non-responder.|||
71884292|NCT02685709|143288442|OTHER|||||||||||||||||This endpoints is descriptive with no formal statistical hypothesis testing|This sensitivity analysis was using the Full analysis set (FAS), where patient who were biochemically controlled at the RCT Baseline (week 26), and who discontinued treatment early was imputed as non-responder.|||
71884293|NCT02685709|143288443|OTHER||Proportion of patients|64.4|||||TWO_SIDED|95.0|56.0|72.1|||||Confidence Interval estimated using the Clopper-Pearson (Exact) method.||The proportion of patients biochemically controlled at the end of the Run-in phase was defined as IGF-1 \< 1.3 times ULN \[based on the average of week 24 and week 26\])|72.1|56|
71884294|NCT02685709|143288444|OTHER||Proportion of patients|66.4|||||TWO_SIDED|95.0|58.5|74.1||||||||74.1|58.5|
71884295|NCT02685709|143288445|OTHER||Proportion of patients|48.9|||||TWO_SIDED|95.0|38.7|59.1||||||||59.1|38.7|
71884296|NCT02685709|143288449|OTHER||||||||||||||||||The LSM change from baseline estimates are from a mixed model for repeated measures.|||
71884297|NCT04417894|143288454|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|||||||=0.0030
71884298|NCT04417894|143288455|SUPERIORITY||Difference|38.6|||<|0.0001|TWO_SIDED|95.0|24.06|53.15|||Mantel Haenszel|||||53.15|24.06|<0.0001
71884299|NCT03440814|143288474|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.294||0.1983|TWO_SIDED|95.0|-4.24|0.89|||Mixed Models Analysis|MMRM analysis adjusted for baseline growth hormone use and HQ-CT total score. All available subject data were used with no imputation of missing data.|alpha=0.05 level of significance|||0.89|-4.24|0.1983
71884300|NCT03440814|143288475|SUPERIORITY|||||||0.0294|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.0294
71884301|NCT03440814|143288476|SUPERIORITY|||||||0.4089|||||||Cochran-Mantel-Haenszel|Treatment groups were compared using CMH mean score test with modified ridit scores, stratified by the randomization stratification variables.||||||0.4089
71884302|NCT03440814|143288477|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.458||0.0225|TWO_SIDED|95.0|-1.95|-0.15|||ANCOVA|ANCOVA adjusted for baseline body fat mass value as a covariate, and randomization stratification variables (as randomized) as factors.||||-0.15|-1.95|0.0225
71884303|NCT03440814|143288478|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|1.481||0.0369|TWO_SIDED|95.0|-6.06|-0.19|||Mixed Models Analysis|Linear mixed model for repeated measurements was used. All available data collected before the March 1, 2020 cutoff from each subject were included.|alpha=0.05 level of significance|||-0.19|-6.06|0.0369
71884304|NCT00879697|143288479|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The effect of training in both groups were assessed by a 2-way ANOVA (Time x Group) for repeated measures. When significance was obtained, the Newman-Keuls post hoc test was used to identify the differences.||||<0.05
71944208|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-1.0||||0.2679|TWO_SIDED|95.0|-2.8|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 26||0.8|-2.8|0.2679
71944209|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-1.2||||0.2137|TWO_SIDED|95.0|-3.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 28||0.7|-3.2|0.2137
71944210|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-1.5||||0.1715|TWO_SIDED|95.0|-3.6|0.6|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 30||0.6|-3.6|0.1715
71944211|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-1.8||||0.134|TWO_SIDED|95.0|-4.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 32||0.5|-4.1|0.1340
71944212|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-2.0||||0.103|TWO_SIDED|95.0|-4.5|0.4|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 34||0.4|-4.5|0.1030
71944213|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-2.4||||0.0788|TWO_SIDED|95.0|-5.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 36||0.3|-5.0|0.0788
71944214|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-2.7||||0.062|TWO_SIDED|95.0|-5.5|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 38||0.1|-5.5|0.0620
71944215|NCT01049334|143410508|SUPERIORITY_OR_OTHER||least-square means difference|-3.0||||0.0476|TWO_SIDED|95.0|-6.0|0.0|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 40||-0.0|-6.0|0.0476
71944216|NCT01049334|143410509|SUPERIORITY_OR_OTHER|||||||0.0273||95.0|||||Log Rank|||||||0.0273
71944217|NCT01049334|143410510|SUPERIORITY_OR_OTHER|||||||0.0098||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0098
71944218|NCT00667095|143410523|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.024
71884305|NCT01110200|143288510|SUPERIORITY_OR_OTHER||Treatment comparison ratio|0.917||||0.71|TWO_SIDED|95.0|0.581|1.447|||Negative bionomial regression model||Annualized rate estimates, the treatment comparison ratio, the confidence interval, and the p-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity, and time on treatment.|||1.447|0.581|0.710
71944219|NCT00667095|143410523|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.036
71944220|NCT00667095|143410524|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.051
71944221|NCT00667095|143410524|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.12
71944222|NCT00667095|143410525|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Change from baseline to 1 month.||||0.42
71944223|NCT00667095|143410525|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.15
71944224|NCT00667095|143410526|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 1 month||||0.18
71944225|NCT00667095|143410526|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.77
71944226|NCT00667095|143410527|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||Change from baseline to one month||||0.67
71944227|NCT00667095|143410527|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change from baseline to 3 months.||||0.20
71884306|NCT01318109|143288523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.751|||||TWO_SIDED|95.0|-0.923|-0.579||||||||-0.579|-0.923|
71884307|NCT01318109|143288523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.858|||||TWO_SIDED|95.0|-1.019|-0.697||||||||-0.697|-1.019|
71884308|NCT01318109|143288524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|||||TWO_SIDED|95.0|-0.247|-0.135||||||||-0.135|-0.247|
71884309|NCT01318109|143288524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.242|-0.143||||||||-0.143|-0.242|
71884310|NCT01318109|143288525|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.386|||||TWO_SIDED|95.0|-0.469|-0.303||||||||-0.303|-0.469|
71884311|NCT01318109|143288525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|||||TWO_SIDED|95.0|-0.484|-0.323||||||||-0.323|-0.484|
71884312|NCT01318109|143288526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.621|||||TWO_SIDED|95.0|-0.757|-0.486||||||||-0.486|-0.757|
71884313|NCT01318109|143288526|SUPERIORITY_OR_OTHER||Hazard Ratio, log|-0.692|||||TWO_SIDED|95.0|-0.814|-0.569||||||||-0.569|-0.814|
71884314|NCT01318109|143288527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.26|||||TWO_SIDED|95.0|-26.12|-12.4||||||||-12.40|-26.12|
71884315|NCT01318109|143288527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.27|||||TWO_SIDED|95.0|-30.43|-16.12||||||||-16.12|-30.43|
71884316|NCT01318109|143288528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||||TWO_SIDED|95.0|-24.54|-10.66||||||||-10.66|-24.54|
71884317|NCT01318109|143288528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.35|||||TWO_SIDED|95.0|-28.32|-14.39||||||||-14.39|-28.32|
71884318|NCT01318109|143288529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.87|||||TWO_SIDED|95.0|-25.95|-11.79||||||||-11.79|-25.95|
71884319|NCT01318109|143288529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||||TWO_SIDED|95.0|-25.43|-10.9||||||||-10.90|-25.43|
71884320|NCT01318109|143288530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.24|||||TWO_SIDED|95.0|-26.32|-10.16||||||||-10.16|-26.32|
71884321|NCT01318109|143288530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.38|||||TWO_SIDED|95.0|-30.87|-13.88||||||||-13.88|-30.87|
71884322|NCT01318109|143288531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|||||TWO_SIDED|95.0|-20.14|2.37||||||||2.37|-20.14|
71884323|NCT01318109|143288531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.41|||||TWO_SIDED|95.0|-16.34|3.52||||||||3.52|-16.34|
71884324|NCT01411085|143288545|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.317|TWO_SIDED||||||t-test, 2 sided|||The assessment was between baseline and values for last 8 weeks.||||0.317
71884325|NCT02193074|143288546|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|50.68|||<|0.0001|TWO_SIDED|95.0|31.81|66.48|||Fisher Exact||exact unconditional confidence interval|||66.48|31.81|< 0.0001
71884326|NCT02193074|143288547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||Log Rank|Based on log-rank test stratified by disease duration.||||||0.0046
71884327|NCT02193074|143288547|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0164|TWO_SIDED|95.0|0.3156|0.8902|||Cox proportional hazards model|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.8902|0.3156|0.0164
71884328|NCT02193074|143288548|SUPERIORITY_OR_OTHER_LEGACY||DIfference in percentages|68.53|||<|0.0001|TWO_SIDED|95.0|51.27|81.99|||Fisher Exact|||||81.99|51.27|< 0.0001
71944228|NCT00667095|143410528|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Change between baseline and one month||||0.31
71884329|NCT02193074|143288549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||Log Rank|Based on log-rank test stratified by disease duration (primary analysis).||||||0.0041
71884330|NCT02193074|143288549|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.372||||0.0082|TWO_SIDED|95.0|0.1787|0.7745|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening (sensitivity analysis).||||0.7745|0.1787|0.0082
71884331|NCT02193074|143288551|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|30.21||||0.0004|TWO_SIDED|95.0|10.35|48.09|||Fisher Exact|||||48.09|10.35|0.0004
71884332|NCT02193074|143288552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Log Rank|||||||0.0003
71884333|NCT02193074|143288552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.24||||0.0014|TWO_SIDED|95.0|0.1002|0.5753|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||0.5753|0.1002|0.0014
71884334|NCT02193074|143288553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3953|||||||Log Rank|||||||0.3953
71884335|NCT02193074|143288553|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.6268|TWO_SIDED|95.0|0.427|1.6698|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject's disease duration at screening.||||1.6698|0.4270|0.6268
71884336|NCT01534533|143288560|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|Chi-squared|||"The null hypothesis was no group difference"||||>0.05
71884337|NCT01534533|143288561|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.992
71884338|NCT01534533|143288562|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.672
71944229|NCT00667095|143410528|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||Change between baseline and 3 months||||0.038
71884339|NCT01534533|143288563|SUPERIORITY_OR_OTHER|||||||0.402||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.402
71884340|NCT01534533|143288564|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"||||0.636
71884341|NCT04311502|143288568|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.21|TWO_SIDED|90.0|0.82|1.79|||Regression, Cox|Adjusted for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).|Arm 1 vs Arm 2|This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.79|0.82|0.21
71884342|NCT04311502|143288569|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.01|TWO_SIDED|90.0|0.14|0.45|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~This outcome measure is limited to data obtained up to September 25, 2023."||0.45|0.14|<0.01
71884343|NCT04311502|143288569|SUPERIORITY||Risk Difference (RD)|0.28|||<|0.01|TWO_SIDED|90.0|0.11|0.44|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|"The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing a Grade 3 or higher AE that is at least one-grade increase from baseline at any time during the 65-week study period was compared between Arm 1 and Arm 2.~All data through week 65."||0.44|0.11|<0.01
71884344|NCT04311502|143288570|SUPERIORITY||Risk Difference (RD)|-0.26||||0.01|TWO_SIDED|95.0|-0.47|-0.06|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.06|-0.47|0.01
71884345|NCT04311502|143288571|SUPERIORITY||Risk Difference (RD)|-0.25||||0.02|TWO_SIDED|95.0|-0.46|-0.04|||Wald chi-square||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 95% two-sided confidence interval for the difference in cumulative proportions of participants experiencing a favorable outcome through week 65 was compared between Arm 1 and Arm 2.||-0.04|-0.46|0.02
71884346|NCT04311502|143288572|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|-0.06||||0.35|TWO_SIDED|95.0|-0.22|0.05|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.05|-0.22|0.35
71884347|NCT04311502|143288574|SUPERIORITY||GEE|24.04|||<|0.01|TWO_SIDED|95.0|15.13|32.94|||Regression, Linear|||||32.94|15.13|<0.01
71884348|NCT04311502|143288576|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.01|TWO_SIDED|95.0|2.4|21.3|||Regression, Logistic|||Compares the odds of participants having maximum occurrence of QTcF change from baseline of ≥30 ms and \<60 ms, or ≥60 ms between Arm 1 and Arm 2 in the safety set using the proportional odds model.||21.30|2.40|<0.01
71884349|NCT04311502|143288576|SUPERIORITY||Risk Difference (RD)|0.41|||<|0.01|TWO_SIDED|95.0|0.17|0.58|||exact unconditional||Arm 1 - Arm 2|Proportion of Participants with Worst Changes in QTcF from Screening \>= 30 ms over visits at Weeks 2, 8, 13||0.58|0.17|<0.01
71884350|NCT04311502|143288577|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.18|TWO_SIDED|90.0|0.84|1.8||One-sided p-value|Regression, Cox|Adjusted for HIV status (positive/negative) and TB disease according to chest X-ray (advanced/not advanced)|Arm 1 vs. Arm 2|||1.80|0.84|0.18
71884351|NCT04311502|143288578|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.25|TWO_SIDED|90.0|0.8|1.71||One-sided p-value|Regression, Cox|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||1.71|0.80|0.25
71884352|NCT04311502|143288579|SUPERIORITY||Risk Difference (RD)|0.13||||0.23|TWO_SIDED|95.0|-0.07|0.35|||Fisher Exact|||||0.35|-0.07|0.23
71884353|NCT04311502|143288580|SUPERIORITY||Risk Difference (RD)|0.05||||0.56|TWO_SIDED|95.0|-0.11|0.24|||Fisher Exact|||||0.24|-0.11|0.56
71944230|NCT01832259|143410548|SUPERIORITY|||||||0.345|||||||t-test, 1 sided|||||||0.345
71944231|NCT01832259|143410550|SUPERIORITY|||||||0.46|||||||Log Rank|||||||0.46
71944232|NCT04000815|143410572|OTHER||||||<|0.017||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||<0.017
71944233|NCT04000815|143410573|OTHER||||||<|0.05|||||||Bi-variate correlation analysis|Bi-variate correlation analyses were performed in groups 1 and 2 between serum CNP and FSH and between serum CNP and LH using Spearman test.||||||<0.05
71884354|NCT04311502|143288581|SUPERIORITY||Risk Difference (RD)|0.07||||0.27|TWO_SIDED|90.0|-0.04|0.18|||Wald chi-square test||Difference in cumulative proportions (Arm 1 - Arm 2)|The point estimate and 90% two-sided confidence intervals for the difference in cumulative proportions of participants experiencing an SAE through week 65 was compared between Arm 1 and Arm 2.||0.18|-0.04|0.27
71884355|NCT04311502|143288582|SUPERIORITY|Fisher's exact test was used to test for a difference in proportions|Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-0.1|0.13|||Fisher Exact||Difference in proportions (Arm 1 - Arm 2); exact confidence interval|||0.13|-0.10|1
71944234|NCT04000815|143410574|OTHER||||||<|0.05|||||||Bi-variate correlation|Spearman test was applied.||||||<0.05
71944235|NCT04000815|143410575|OTHER||||||<|0.05|||||||Bi-variate correlation analyses|Bi-variate correlation analyses were performed for all subjects in groups 1 and 2 between serum CNP and E2 using Spearman test.||||||<0.05
71944236|NCT03988803|143410615|OTHER||Ratio of the geometric means (T/R1)|94.8|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|90.0|87.14|103.14|||ANOVA||Standard error of the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.14|87.14|
71944237|NCT03988803|143410616|OTHER||Ratio of the geometric means (T/R1)|99.34|STANDARD_ERROR_OF_MEAN|12.3|||TWO_SIDED|90.0|91.22|108.18|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||108.18|91.22|
71944238|NCT03988803|143410617|OTHER||Ratio of the geometric means (T/R2)|103.69|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|99.99|107.52|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||107.52|99.99|
71944239|NCT03988803|143410618|OTHER||Ratio of the geometric means (T/R2)|107.45|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|102.66|112.45|||ANOVA||Standard error fo the mean is the geometric coefficient of variation|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That was, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. The model used included effects accounting for the following sources of variation: subjects and treatment. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||112.45|102.66|
71944240|NCT00840099|143410627|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of Means x 100|100.91||||||90.0|95.82|106.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.26|95.82|
71944241|NCT00840099|143410628|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.79||||||90.0|100.69|104.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.94|100.69|
71944242|NCT00840099|143410629|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.75||||||90.0|100.62|104.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.93|100.62|
71944243|NCT00840099|143410630|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the Mean x 100|100.47||||||90.0|93.28|108.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.20|93.28|
71944244|NCT00840099|143410631|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Ratio of the mean|104.15||||||90.0|96.35|112.58|||||Bioequivalence is established when 80% Confidence Interval falls within 80 - 125|||112.58|96.35|
71944245|NCT00840099|143410632|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|104.06||||||90.0|95.85|112.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.97|95.85|
71944246|NCT01032083|143410633|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|-1.54||||0.36|TWO_SIDED|95.0|-4.91|1.8|||Regression, Linear|||||1.80|-4.91|0.36
71944247|NCT01032083|143410634|EQUIVALENCE|For the primary outcome, linear regression was used to determine mean difference between treatment groups. Differences between groups are presented as mean differences with associated 95% confidence interval (CI). Baseline values for variables were included as covariates in regression models and adjusted according to analysis of covariance. All analyses were conducted under the intention-to-treat principle.|Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-9.0|14.0|||Regression, Linear|||||14|-9|0.68
71944248|NCT00377260|143410730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.||||< .001
71884356|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.597|TWO_SIDED|95.0|0.57|1.39|||Regression, Cox|||Time point: Screening||1.39|0.57|0.597
71884357|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.58|1.44|||Regression, Cox|||Time point: Entry||1.44|0.58|0.70
71884358|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07|TWO_SIDED|95.0|0.4|1.03|||Regression, Cox|||Time point: Week 2||1.03|0.40|0.07
71884359|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.04|TWO_SIDED|95.0|0.34|0.98|||Regression, Cox|||Time point: Week 4||0.98|0.34|0.04
71884360|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6|TWO_SIDED|95.0|0.41|1.67|||Regression, Cox|||Time point: Week 6||1.67|0.41|0.60
71884361|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.595|TWO_SIDED|95.0|0.33|1.88|||Regression, Cox|||Time point: Week 8||1.88|0.33|0.595
71884362|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.66|TWO_SIDED|95.0|0.25|2.44|||Regression, Cox|||Time point: Week 10||2.44|0.25|0.66
71884363|NCT04311502|143288583|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.86|TWO_SIDED|95.0|0.21|6.39|||Regression, Cox|||Time point: Week 12||6.39|0.21|0.86
71884364|NCT04311502|143288584|SUPERIORITY||Slope|20.43|||<|0.01|TWO_SIDED|95.0|5.71|35.16|||Regression, Linear|||This comparison is adjusting for HIV-1 status (positive/negative) and TB Disease at Screening (Advanced/Not Advanced).||35.16|5.71|<0.01
71884365|NCT03040999|143288596|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1997|TWO_SIDED|95.0|0.71|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.15|0.71|0.1997
71884366|NCT03040999|143288599|OTHER||Difference in Least squares mean|-4.24||||0.0015|TWO_SIDED|95.0|-6.85|-1.63|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||-1.63|-6.85|0.0015
71884367|NCT03040999|143288600|OTHER||Difference in Least squares mean|-0.51||||0.7719|TWO_SIDED|95.0|-3.98|2.96|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.96|-3.98|0.7719
71884368|NCT03040999|143288601|OTHER||Difference in Least squares mean|-1.29||||0.45|TWO_SIDED|95.0|-4.64|2.06|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||2.06|-4.64|0.4500
71884369|NCT03040999|143288602|OTHER||Difference in Least squares mean|1.29||||0.3524|TWO_SIDED|95.0|-1.43|4.02|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||4.02|-1.43|0.3524
71884370|NCT03040999|143288603|OTHER||Difference in Least squares mean|-2.05||||0.0963|TWO_SIDED|95.0|-4.47|0.37|||cLDA||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.|Difference in Least Squares Mean||0.37|-4.47|0.0963
71884371|NCT03040999|143288604|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0429|TWO_SIDED|95.0|0.68|1.03||P-value crossing boundary of 0.0242 required for statistical significance.|Log Rank|One-sided p-value based on log-rank test stratified by human papilloma virus (HPV) status and overall cancer stage.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by HPV status and overall cancer stage.|||1.03|0.68|0.0429
71884372|NCT01408147|143288643|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||To test the primary hypothesis, a generalized linear mixed effect model was used (intervention group as a fixed effect and clinic and subject as random effects). A group x time interaction term (fixed effect) tested if the change in weight over time differed significantly. The model included participant-level covariates (i.e., ethnicity, weeks postpartum at study entry, lactation, and age).||||<0.0001
71884373|NCT01662440|143288645|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.|Difference in percentages of subjects|0.0|||||TWO_SIDED|97.5|-2.8|2.8||||||To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.||2.8|-2.8|
71884374|NCT01662440|143288646|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|97.5|-4.8|7.9||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination||7.9|-4.8|
71884375|NCT01662440|143288647|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.|Between groups ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.86|1.32||||||Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination||1.32|0.86|
71884376|NCT01662440|143288648|NON_INFERIORITY_OR_EQUIVALENCE|The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.||1.13|0.68|
71890384|NCT00348140|143302369|SUPERIORITY||Mean Difference (Net)|-0.1|||=|0.8|TWO_SIDED|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.9|-1.1|=0.800
71944249|NCT00377260|143410731|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.||||< .001
71944250|NCT00377260|143410732|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||.02
71944251|NCT00377260|143410733|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.||||.24
71944252|NCT00377260|143410734|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.|Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.||||.35
71944253|NCT00377260|143410735|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.||||.04
71944254|NCT00377260|143410735|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.||||<.01
71944255|NCT00377260|143410735|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.||||.07
71890385|NCT00348140|143302370|SUPERIORITY||Mean Difference (Net)|-0.1||||0.611|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.7|0.611
71944256|NCT00377260|143410735|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.||||>.99
71944257|NCT00377260|143410735|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.||||>.99
71944258|NCT00377260|143410735|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.||||.99
71944259|NCT00377260|143410735|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.||||.08
71944260|NCT00377260|143410736|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.002
71944261|NCT00377260|143410736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||<.001
71944262|NCT00377260|143410736|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.85
71944263|NCT00377260|143410736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||<.001
71944264|NCT00377260|143410736|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.28
71944265|NCT00377260|143410737|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||< .001
71890386|NCT00348140|143302370|SUPERIORITY||Mean Difference (Net)|-0.1||||0.741|TWO_SIDED|95.0|-0.6|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.4|-0.6|0.741
71890387|NCT00348140|143302371|SUPERIORITY||Mean Difference (Net)|0.0||||0.913|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.3|-0.4|0.913
71944266|NCT00377260|143410738|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.||||.10
71944267|NCT00377260|143410738|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.||||.03
71944268|NCT00377260|143410738|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.||||.96
71944269|NCT00377260|143410738|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.||||.79
71944270|NCT00377260|143410738|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.||||.98
71944271|NCT00377260|143410739|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.||||.04
71944272|NCT00377260|143410740|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.||||.03
71944273|NCT00377260|143410741|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.||||.006
71944274|NCT00377260|143410742|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.||||.04
71944275|NCT00377260|143410743|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.||||.20
71944276|NCT00377260|143410744|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to emergency room||||.90
71884377|NCT01662440|143288649|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-3.8|1.4||||||Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination||1.4|-3.8|
71944277|NCT00377260|143410745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.14||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1.||||.14
71944278|NCT00377260|143410746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.04||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score \<=1 on two consecutive occasions.||||.04
71944279|NCT00377260|143410747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Generalized estimating equations|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.||||<.001
71944280|NCT00377260|143410748|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.||||.93
71944281|NCT00377260|143410749|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.||||.66
71944282|NCT00377260|143410750|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.||||.71
71944283|NCT00377260|143410751|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.||||.04
71890388|NCT00348140|143302371|SUPERIORITY||Mean Difference (Net)|-0.1||||0.481|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.481
71890389|NCT00348140|143302372|SUPERIORITY||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.4|0.557
71890390|NCT00348140|143302372|SUPERIORITY||Mean Difference (Net)|-0.1||||0.404|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|||0.2|-0.5|0.404
71890391|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.1||||0.633|TWO_SIDED|95.0|-0.5|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.5|0.633
71890392|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.2||||0.575|TWO_SIDED|95.0|-0.4|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.8|-0.4|0.575
71890393|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.1||||0.82|TWO_SIDED|95.0|-0.6|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-0.6|0.820
71890394|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.0||||0.908|TWO_SIDED|95.0|-0.7|0.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.6|-0.7|0.908
71890395|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.1|-0.3|0.292
71890396|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.0||||0.978|TWO_SIDED|95.0|-0.7|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.7|0.978
71890397|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|0.2||||0.691|TWO_SIDED|95.0|-0.6|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||1.0|-0.6|0.691
71890398|NCT00348140|143302373|SUPERIORITY||Mean Difference (Net)|-0.1||||0.849|TWO_SIDED|95.0|-0.9|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.8|-0.9|0.849
71890399|NCT00348140|143302374|SUPERIORITY||Mean Difference (Net)|0.0||||0.938|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.938
71890400|NCT00348140|143302374|SUPERIORITY||Mean Difference (Net)|0.0||||0.887|TWO_SIDED|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12||0.2|-0.2|0.887
71890401|NCT00348140|143302374|SUPERIORITY||Mean Difference (Net)|-0.1||||0.465|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.2|-0.4|0.465
71890402|NCT00348140|143302374|SUPERIORITY||Mean Difference (Net)|0.1||||0.596|TWO_SIDED|95.0|-0.2|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.3|-0.2|0.596
71890403|NCT00348140|143302374|SUPERIORITY||Mean Difference (Net)|-0.1||||0.452|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.452
71890404|NCT00348140|143302374|SUPERIORITY||Mean Difference (Net)|-0.1||||0.429|TWO_SIDED|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.2|-0.4|0.429
71890405|NCT00348140|143302375|SUPERIORITY||Mean Difference (Net)|-0.3||||0.386|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.386
71890406|NCT00348140|143302375|SUPERIORITY||Mean Difference (Net)|0.0||||0.999|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.999
71944284|NCT00377260|143410752|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.||||.005
71884378|NCT01662440|143288650|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.|Difference in percentages of subjects|-1.0|||||TWO_SIDED|95.0|-4.1|6.2||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.||6.2|-4.1|
71944285|NCT00377260|143410753|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.||||.01
71944286|NCT00829530|143410754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.87||||||90.0|80.31|98.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.34|80.31|
71944287|NCT00829530|143410755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.96||||||90.0|89.77|100.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.45|89.77|
71944288|NCT00829530|143410756|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.24||||||90.0|90.13|100.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.63|90.13|
71944289|NCT00829530|143410757|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.85||||||90.0|91.95|106.27|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.27|91.95|
71944290|NCT00829530|143410758|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.62||||||90.0|97.8|103.52|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.52|97.8|
71944291|NCT00840866|143410759|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.0|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109|99|
71944292|NCT00840866|143410760|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.9||||||90.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.6|
71944293|NCT00840866|143410761|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|98.5|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|98.5|
71884379|NCT01661140|143288660|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority if the difference between treatments is statistically significant and the lower limit of the 95% confidence interval (CI) is greater than 0.9.|Odds Ratio (OR)|1.803||||0.036|TWO_SIDED|95.0|1.037|3.133|||Analysis by logistic regression|||Comparison was Tapering MTX : MTX maintenance. Last post-baseline EULAR response recorded used for participants with a missing result at Week 60.||3.133|1.037|0.036
71944294|NCT04112823|143410762|SUPERIORITY||Risk Ratio (RR)|7.0|||||TWO_SIDED|95.0|-6.0|20.0||||||||20|-6|
71944295|NCT04112823|143410763|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-8.0|16.0||||||||16|-8|
71944296|NCT04112823|143410764|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|-8.0|14.0||||||||14|-8|
71944297|NCT04112823|143410766|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||||1.2|-0.3|
71944298|NCT04112823|143410767|SUPERIORITY||Risk Ratio (RR)|4.0|||||TWO_SIDED|95.0|-9.0|18.0||||||||18|-9|
71944299|NCT02924883|143410778|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3332||95.0|0.55|1.23|||Log Rank|The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.23|0.55|0.3332
71944300|NCT02924883|143410780|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2934||95.0|0.42|1.3|||Log Rank|The 2-sided log-rank test was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).||||1.30|0.42|0.2934
71944301|NCT02924883|143410782|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.6099||95.0|0.52|3.03|||Log Rank|Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).||||3.03|0.52|0.6099
71944302|NCT00234286|143410801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.009|TWO_SIDED|95.0|1.09|1.76|||Generalized Estimating Equation|||||1.76|1.09|.009
71944303|NCT00234286|143410802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
71944304|NCT00234286|143410803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.69|TWO_SIDED|95.0|0.59|1.42|||Generalized Estimating Equation|||||1.42|0.59|0.69
71944305|NCT00234286|143410804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.03|TWO_SIDED|95.0|0.53|0.96|||Generalized Estimating Equations|||||0.96|0.53|.03
71944306|NCT00234286|143410805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.15|TWO_SIDED|95.0|0.38|1.16|||Generalized Estimating Equation|||||1.16|0.38|0.15
71944307|NCT00234286|143410806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.67|1.62|||Generalized Estimating Equation|||||1.62|0.67|0.86
71944308|NCT00234286|143410807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.96|||Generalized Estimating Equation|||||1.96|0.95|0.09
71944309|NCT00234286|143410808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.01|TWO_SIDED|95.0|1.17|3.36|||Generalized Estimating Equation|||||3.36|1.17|0.01
71944310|NCT00234286|143410809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.36|TWO_SIDED|95.0|0.73|2.35|||Generalized Estimating Equation|||||2.35|0.73|0.36
71944311|NCT00234286|143410810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.01|TWO_SIDED|95.0|1.08|1.77|||Generalized Estimating Equation|||||1.77|1.08|0.01
71944312|NCT00234286|143410811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.76|TWO_SIDED|95.0|0.7|1.3|||Generalized Estimating Equation|||||1.30|0.70|0.76
71944313|NCT00234286|143410812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.41|5.44|||Generalized Estimating Equation|||||5.44|1.41|.004
71944314|NCT00234286|143410813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.007|TWO_SIDED|95.0|1.51|11.28|||Generalized Estimating Equations|||||11.28|1.51|0.007
71944315|NCT00234286|143410814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.14|TWO_SIDED|95.0|0.84|3.2|||Generalized Estimating Equations|||||3.20|0.84|0.14
71944316|NCT00234286|143410815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.003|TWO_SIDED|95.0|1.15|1.88|||Generalized Estimating Equation|||||1.88|1.15|.003
71944317|NCT00234286|143410816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.19|TWO_SIDED|95.0|0.62|9.7|||Generalized Estimation Equations|||||9.70|0.62|0.19
71944318|NCT04459585|143410823|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.88|||||TWO_SIDED|90.0|77.57|161.35|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||161.35|77.57|
71944319|NCT04459585|143410823|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.98|||||TWO_SIDED|90.0|77.2|165.34|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||165.34|77.20|
71944320|NCT04459585|143410824|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.37|||||TWO_SIDED|90.0|78.51|157.97|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||157.97|78.51|
71944321|NCT04459585|143410824|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|111.08|||||TWO_SIDED|90.0|77.35|159.51|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.51|77.35|
71944322|NCT04459585|143410825|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|112.97|||||TWO_SIDED|90.0|79.38|160.79|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Total Dabigatran.||160.79|79.38|
71944323|NCT04459585|143410825|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|110.72|||||TWO_SIDED|90.0|76.77|159.68|||||For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.|Statistical comparison was analyzed for Free Dabigatran.||159.68|76.77|
71944324|NCT00772941|143410832|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events."||||<0.001
71944325|NCT00772941|143410833|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of Treatment Related Adverse Events."||||<0.001
71944326|NCT00772941|143410834|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events."||||<0.001
71944327|NCT00772941|143410835|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events."||||<0.001
71944328|NCT00772941|143410836|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events."||||<0.001
71944329|NCT00772941|143410837|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events."||||<0.001
71944330|NCT00772941|143410837|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline."||||<0.001
71944331|NCT00772941|143410838|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline."||||<0.001
71944332|NCT00772941|143410838|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Armitage|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day."||||<0.001
71944333|NCT00772941|143410839|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline."||||<0.001
71944334|NCT00772941|143410840|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline."||||<0.001
71944335|NCT02251886|143410867|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.48|TWO_SIDED|95.0|0.77|1.76|||Chi-squared|||||1.76|0.77|0.48
71944336|NCT02251886|143410867|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.69|1.46|||Chi-squared|||||1.46|0.69|1.00
71944337|NCT00855738|143410892|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||<0.0001
71944338|NCT00855738|143410892|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
71884380|NCT00439946|143288678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
71944339|NCT00855738|143410893|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=25% reduction: p-value versus baseline.||||<0.0001
71944340|NCT00855738|143410893|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 3 \>=75% reduction: p-value versus baseline.||||<0.0001
71944341|NCT00855738|143410893|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=25% reduction: p-value versus baseline.||||<0.0001
71944342|NCT00855738|143410893|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: \>=75% reduction: p-value versus baseline.||||<0.0001
71944343|NCT00855738|143410894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0039|TWO_SIDED||||||McNemar|||Month 3: p-value versus baseline.||||0.0039
71944344|NCT00855738|143410894|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||<0.0001
71944345|NCT00855738|143410895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71944346|NCT00855738|143410906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1797|TWO_SIDED||||||t-test, 2 sided|||Depression domain: P-value vs baseline.||||0.1797
71944347|NCT00855738|143410906|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0433|TWO_SIDED||||||t-test, 2 sided|||Anxiety domain: P-value vs baseline.||||0.0433
71884381|NCT00439946|143288679|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71944348|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8284|TWO_SIDED||||||t-test, 2 sided|||Energy: p-value versus baseline.||||0.8284
71944349|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6299|TWO_SIDED||||||t-test, 2 sided|||Emotions (mood): p-value versus baseline.||||0.6299
71944350|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6162|TWO_SIDED||||||t-test, 2 sided|||Daily activities: p-value versus baseline.||||0.6162
71944351|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||t-test, 2 sided|||Mental function: p-value versus baseline.||||0.5609
71944352|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4635|TWO_SIDED||||||t-test, 2 sided|||Medication effects (physical/ mental): p-value versus baseline.||||0.4635
71944353|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Worry about seizures (impact of seizures): p-value versus baseline.||||<0.0001
71944354|NCT00855738|143410907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0258|TWO_SIDED||||||t-test, 2 sided|||Overall quality of life: p-value versus baseline.||||0.0258
71944355|NCT00855738|143410908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7822|TWO_SIDED||||||t-test, 2 sided|||Month 3: p-value versus baseline.||||0.7822
71944356|NCT00855738|143410908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||t-test, 2 sided|||Month 6: p-value versus baseline.||||0.4471
71944357|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2452|TWO_SIDED||||||t-test, 2 sided|||Sleep disturbance: p-value versus baseline.||||0.2452
71944358|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Snoring: p-value verus baseline.||||1.0000
71944359|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4253|TWO_SIDED||||||t-test, 2 sided|||Awake short of breath: p-value versus baseline.||||0.4253
71944360|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0572|TWO_SIDED||||||t-test, 2 sided|||Quantity: p-value versus baseline.||||0.0572
71944361|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0625|TWO_SIDED||||||t-test, 2 sided|||Adequacy: p-value versus baseline.||||0.0625
71944362|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554|TWO_SIDED||||||t-test, 2 sided|||Somnolence: p-value versus baseline.||||0.5540
71944363|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4204|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 6): p-value versus baseline.||||0.4204
71944364|NCT00855738|143410909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869|TWO_SIDED||||||t-test, 2 sided|||Sleep problems (summary 9): p-value versus baseline.||||0.4869
71944365|NCT00855738|143410910|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0863|TWO_SIDED||||||McNemar|||Month 6: p-value versus baseline.||||0.0863
71944366|NCT00855738|143410911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0226|TWO_SIDED||||||t-test, 2 sided|||Number of visits to a specialist because of epilepsy: p-value versus baseline.||||0.0226
71944367|NCT00855738|143410911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||t-test, 2 sided|||Number of visits to the emergency room because of epilepsy: p-value versus baseline.||||0.0017
71944368|NCT00855738|143410912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3141|TWO_SIDED||||||t-test, 2 sided|||P-value versus baseline.||||0.3141
71944369|NCT00855738|143410913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0708|TWO_SIDED||||||t-test, 2 sided|||Cessation of usual occupation: p-value versus baseline.||||0.0708
71944370|NCT00855738|143410913|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Requirement of informal caregiver: p-value versus baseline.||||1.0000
71944371|NCT00855738|143410913|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||t-test, 2 sided|||Required admission to ICU: p-value versus baseline.||||1.0000
71944372|NCT03707912|143410920|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71944373|NCT03707912|143410921|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71944374|NCT03707912|143410922|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
71944375|NCT03707912|143410922|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.98|||||||Breslow-Day test|||||||0.98
71944376|NCT03707912|143410923|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71944377|NCT03707912|143410924|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71944378|NCT03707912|143410924|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.75|||||||Breslow-Day test|||||||0.75
71944379|NCT03707912|143410925|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Day 1 comparison.||||0.89
71944380|NCT03707912|143410925|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Day 2 comparison.||||0.75
71944381|NCT03707912|143410925|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 3 comparison.||||0.34
71944382|NCT03707912|143410926|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
71944383|NCT00834535|143410965|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.83||||||90.0|93.98|108.17|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.17|93.98|
71944384|NCT00834535|143410966|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.1||||||90.0|92.14|100.22|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.22|92.14|
71944385|NCT00834535|143410967|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.57||||||90.0|92.8|100.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.49|92.8|
71944386|NCT02055963|143410977|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||||||0.98
71944387|NCT01819597|143410987|OTHER|This is a phase II study design to determine the non-futility of proceeding to a phase III pivotal evaluation. The study group was planned to be compared to a propensity score matching (PSM) cohort from to the patients in the medical arms of the SAMMPRIS trial and to patients in the medical arm of COSS that had demonstrated angiographic intracranial atherosclerosis and occlusion.|Hazard Ratio (HR)|0.38||||0.08|TWO_SIDED|90.0|0.14|0.94||Pre-established α ≤ 0.10 for phase IIa|Regression, Cox|Alpha set at ≤ 0.1. for phase II study|ERSIAS/ Controls.|We derived the sample size required to power the trial to test the difference between two binomial event rates using the method of Farrington and Manning as implemented in R package gsDesign (Anderson, 2011). An estimated sample size of 52 patients will be necessary to detect a ∆ of 0.05, with a one-sided alpha of 0.10 and a beta of 0.10 - acceptable parameters for a non-definitive, non-futility study (Palesch et al., 2005, Levin, 2005).||0.94|0.14|0.08
71944388|NCT02495857|143410994|SUPERIORITY||Mean Difference (Net)|36.18|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
71944389|NCT02495857|143410995|SUPERIORITY||Mean Difference (Net)|36.19|||||TWO_SIDED|95.0|10.25|62.11||||||||62.11|10.25|
71944390|NCT02495857|143410996|EQUIVALENCE|From baseline to week 26 visit, change in the WOMAC stiffness score was evaluated.|Mean Difference (Net)|5.63|||||TWO_SIDED|95.0|-13.61|8.49||||||||8.49|-13.61|
71944391|NCT02883452|143411004|NON_INFERIORITY|The non-inferiority of CT-P13 SC to CT-P13 IV was to be concluded if the lower bound of two-sided 90% CI for the ratio of geometric least square means was higher than 80%.|Ratio of Geometric LS means|1154.17|||||TWO_SIDED|90.0|786.37|1694.0|||||The geometric lease square (LS) means, ratio of geometric LS means (CT-P13 SC 120/240 mg to CT-P13 IV 5 mg/kg), and 2-sided 90% CI were obtained from the ANCOVA model.|Primary PK analysis was analyzed using an ANCOVA with treatment as fixed effect and current use of treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) (used or not used), disease (CD or UC), clinical response at Week 6 (responder or non-responder by Clinical Disease Activity Index \[CDAI\]-70 for CD or partial Mayo score for UC), body weight at Week 6 (\<80 kg or ≥80 kg) fitted as covariates.||1694.00|786.37|
71884382|NCT00439946|143288680|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71944392|NCT00830206|143411011|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® Software.|Geometric Test/Ref Ratio x 100|102.62||||||90.0|94.84|111.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.05|94.84|
71944393|NCT00830206|143411012|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|100.85||||||90.0|94.48|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|94.48|
71944394|NCT00830206|143411013|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on the pharmacokimetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|101.92||||||90.0|95.18|109.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.14|95.18|
71944395|NCT00905346|143411015|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|98.39||||||90.0|94.36|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.59|94.36|
71944396|NCT00905346|143411016|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.92||||||90.0|99.88|106.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.05|99.88|
71944397|NCT00905346|143411017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.63||||||90.0|99.24|106.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.14|99.24|
71884383|NCT00439946|143288681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
71944398|NCT02724462|143411021|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic|||||1.83|1.22|<.001
71944399|NCT02724462|143411022|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Regression, Logistic|||||1.71|1.14|.001
71944400|NCT02393417|143411055|SUPERIORITY||Risk Ratio (RR)|1.5706||||0.0329|TWO_SIDED|95.0|1.0184|2.4223|||Cochran-Mantel-Haenszel|||||2.4223|1.0184|0.0329
71700438|NCT01013753|142916435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|STANDARD_ERROR_OF_MEAN|0.122||0.0004||95.0|-0.671|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.671|0.0004
71884384|NCT00439946|143288682|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
71944401|NCT02393417|143411055|SUPERIORITY||Risk Ratio (RR)|1.8926||||0.0007|TWO_SIDED|95.0|1.2722|2.8156|||Cochran-Mantel-Haenszel|||||2.8156|1.2722|0.0007
71944402|NCT02393417|143411055|SUPERIORITY||Risk Ratio (RR)|1.7319||||0.0052|TWO_SIDED|95.0|1.1602|2.5854|||Cochran-Mantel-Haenszel|||||2.5854|1.1602|0.0052
71944403|NCT02393417|143411056|SUPERIORITY||Risk Ratio (RR)|1.3828||||0.4307|TWO_SIDED|95.0|0.6191|3.0883|||Cochran-Mantel-Haenszel|||||3.0883|0.6191|0.4307
71944404|NCT02393417|143411056|SUPERIORITY||Risk Ratio (RR)|2.8908||||0.0014|TWO_SIDED|95.0|1.4169|5.8978|||Cochran-Mantel-Haenszel|||||5.8978|1.4169|0.0014
71944405|NCT02393417|143411056|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0451|TWO_SIDED|95.0|0.9281|9.6975|||Cochran-Mantel-Haenszel|||||9.6975|0.9281|0.0451
71944406|NCT02393417|143411058|SUPERIORITY||Cox Proportional Hazard|2.7553||||0.0027|TWO_SIDED|95.0|1.4211|5.3419|||Regression, Cox|||||5.3419|1.4211|0.0027
71944407|NCT02393417|143411058|SUPERIORITY||Cox Proportional Hazard|3.1516||||0.0008|TWO_SIDED|95.0|1.6148|6.1509|||Regression, Cox|||||6.1509|1.6148|0.0008
71944408|NCT02393417|143411058|SUPERIORITY||Cox Proportional Hazard|3.3257||||0.0003|TWO_SIDED|95.0|1.7263|6.407|||Regression, Cox|||||6.4070|1.7263|0.0003
71944409|NCT02393417|143411064|SUPERIORITY||Odds Ratio (OR)|0.999||||0.4824|TWO_SIDED|95.0|0.997|1.001|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.001|0.997|0.4824
71944410|NCT02393417|143411064|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5007|TWO_SIDED|95.0|0.998|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.998|0.5007
71944411|NCT02393417|143411064|SUPERIORITY||Odds Ratio (OR)|0.993||||0.0219|TWO_SIDED|95.0|0.987|0.999|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||0.999|0.987|0.0219
71944412|NCT02393417|143411064|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8267|TWO_SIDED|95.0|0.995|1.004|||Regression, Logistic||An odds ratio \< 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.||1.004|0.995|0.8267
71944413|NCT02393417|143411065|SUPERIORITY||Odds Ratio (OR)|0.964||||0.1657|TWO_SIDED|95.0|0.915|1.015|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.015|0.915|0.1657
71944414|NCT02393417|143411065|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8168|TWO_SIDED|95.0|0.997|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.997|0.8168
71944415|NCT02393417|143411065|SUPERIORITY||Odds Ratio (OR)|0.998||||0.4183|TWO_SIDED|95.0|0.993|1.003|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.003|0.993|0.4183
71944416|NCT02393417|143411065|SUPERIORITY||Odds Ratio (OR)|1.001||||0.5572|TWO_SIDED|95.0|0.997|1.006|||Regression, Logistic||An odds ratio \> 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.||1.006|0.997|0.5572
71944417|NCT00829673|143411092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.82||||||90.0|100.24|115.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115.98|100.24|
71700439|NCT01013753|142916435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.478|STANDARD_ERROR_OF_MEAN|0.123||0.0001||95.0|-0.72|-0.237|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.237|-0.720|0.0001
71700440|NCT01013753|142916435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001||95.0|-0.901|-0.413|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.413|-0.901|<0.0001
71884385|NCT00439946|143288683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.50
71700441|NCT01013753|142916435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.449|STANDARD_ERROR_OF_MEAN|0.123||0.0003||95.0|-0.691|-0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.207|-0.691|0.0003
71884386|NCT00439946|143288684|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
71884387|NCT00439946|143288685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||0.75
71884388|NCT00439946|143288686|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.0
71884389|NCT00439946|143288687|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values||||1.00
71944418|NCT00829673|143411093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.74||||||90.0|97.3|104.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.29|97.3|
71944419|NCT00829673|143411094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.5||||||90.0|97.09|104.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.03|97.09|
71944420|NCT03450057|143411095|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71944421|NCT03450057|143411096|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71884390|NCT00439946|143288688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||p-value for: Gather/set-up|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.95
71944422|NCT03450057|143411097|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71944423|NCT03450057|143411098|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71944424|NCT03450057|143411099|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71944425|NCT03450057|143411100|OTHER|The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.|||||||||||||||||The PFS function was estimated using the Kaplan-Meier product-limit method. Median and one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.|||
71944426|NCT02246166|143411102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9473|TWO_SIDED|95.0|-0.77|0.83|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||0.83|-0.77|0.9473
71944427|NCT02246166|143411103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.721|TWO_SIDED|95.0|-1.23|0.86|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme|||0.86|-1.23|0.7210
71944428|NCT02246166|143411104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.7445|TWO_SIDED|95.0|-1.07|1.49|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.||||1.49|-1.07|0.7445
71944429|NCT02246166|143411105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.7662|TWO_SIDED|95.0|-1.32|1.78|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate||||1.78|-1.32|0.7662
71944430|NCT02246166|143411106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.5208|TWO_SIDED|95.0|-1.18|2.29|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||2.29|-1.18|0.5208
71944431|NCT02246166|143411107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8993|TWO_SIDED|95.0|-1.71|1.94|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment|||1.94|-1.71|0.8993
71884391|NCT00439946|143288688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||p-value for: Prepare drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.02
71884392|NCT00439946|143288688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0||||p-value for: Connect drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.20
71944432|NCT02678286|143411142|SUPERIORITY|||||||0.0145|||||||t-test, 2 sided|||||||0.0145
71944433|NCT02678286|143411143|SUPERIORITY|||||||0.1841||||||Row 1 (SPID6)|t-test, 2 sided|||||||0.1841
71944434|NCT02678286|143411143|SUPERIORITY|||||||0.0434||||||Row 2 (SPID12)|t-test, 2 sided|||||||0.0434
71944435|NCT02678286|143411143|SUPERIORITY|||||||0.004||||||Row 3 (SPID48)|t-test, 2 sided|||||||0.0040
71944436|NCT02678286|143411143|SUPERIORITY|||||||0.0028||||||Row 4 (SPID24-48)|t-test, 2 sided|||||||0.0028
71944437|NCT02678286|143411144|SUPERIORITY|||||||0.7572|||||||Log Rank|||||||0.7572
71944438|NCT02678286|143411145|SUPERIORITY|||||||0.6559||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||0.6559
71944439|NCT02678286|143411145|SUPERIORITY|||||||0.0014||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||0.0014
71944440|NCT02678286|143411145|SUPERIORITY|||||||0.4994||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||0.4994
71944441|NCT02678286|143411146|SUPERIORITY|||||||0.0275||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0275
71944442|NCT02678286|143411146|SUPERIORITY|||||||0.0009||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0009
71944443|NCT02678286|143411146|SUPERIORITY|||||||0.0027||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||0.0027
71944444|NCT02678286|143411147|SUPERIORITY|||||||0.005|||||||Log Rank|||||||0.0050
71944445|NCT02678286|143411148|SUPERIORITY|||||||0.5096|||||||Log Rank|||||||0.5096
71944446|NCT02678286|143411149|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
71944447|NCT02678286|143411150|SUPERIORITY|||||||0.0178|||||||Cochran-Mantel-Haenszel|||||||0.0178
71944448|NCT02678286|143411151|SUPERIORITY|||||||0.1888|||||||Cochran-Mantel-Haenszel|||||||0.1888
71944449|NCT02678286|143411152|SUPERIORITY|||||||0.0788|||||||Cochran-Mantel-Haenszel|||||||0.0788
71944450|NCT02678286|143411153|SUPERIORITY|||||||0.0607|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0607
71944451|NCT02678286|143411154|SUPERIORITY|||||||0.0027|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0027
71944452|NCT02459951|143411168|SUPERIORITY|||||||0.059||||||"refer to cylinder A (.5 diameter)"|Regression, Logistic|||||||.059
71944453|NCT02459951|143411168|SUPERIORITY||geometric mean ratio B|||||0.465|||||||Regression, Logistic|"refer to cylinder B(1 diameter)"||||||0.465
71944454|NCT02459951|143411168|SUPERIORITY||geometric mean ratio C|||||0.022||||||"refer to cylinder C (1.5 diameter)"|Regression, Logistic|||||||.022
71944455|NCT02459951|143411168|SUPERIORITY||geometric mean ratio D|||||0.004||||||"refer to cylinder D (2 diameter)"|Regression, Logistic|||||||.004
71944456|NCT02459951|143411168|SUPERIORITY||geometric mean ratio E|||||0.002||||||"refer to cylinder E (2.5 diameter)"|Regression, Logistic|||||||.002
71944457|NCT02255097|143411175|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71944458|NCT02255097|143411176|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71944459|NCT02255097|143411179|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71944460|NCT02255097|143411180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||0.0027
71944461|NCT02255097|143411181|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71884393|NCT00439946|143288688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||p-value for: Change dressing|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.48
71944462|NCT02255097|143411182|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71884394|NCT00439946|143288688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||p-value for: Total time|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.11
71944463|NCT02255097|143411183|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p \> 0.05||Analysis comparing the ORR for pembrolizumab to a fixed efficacy target of 5% using an exact test of binomial distribution||||<0.001
71944464|NCT03956862|143411237|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9499|TWO_SIDED|95.0|-7.6|7.1|||Mixed Models Analysis||GB001 vs. Placebo|||7.1|-7.6|0.9499
71944465|NCT03956862|143411238|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6778|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA||GB001 vs. Placebo|||1.2|-1.8|0.6778
71944466|NCT03956862|143411239|SUPERIORITY||Mean Difference (Net)|0.1||||0.7914|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis||GB001 vs. Placebo|||0.9|-0.7|0.7914
71944467|NCT03956862|143411240|SUPERIORITY||Hazard Ratio (HR)|0.944||||0.8916|TWO_SIDED|95.0|0.41|2.173|||Regression, Cox||GB001 vs Placebo|||2.173|0.410|0.8916
71944468|NCT03956862|143411241|SUPERIORITY||Mean Difference (Net)|0.191||||0.1635|TWO_SIDED|95.0|-0.077|0.459|||Mixed Models Analysis||GB001 vs. Placebo|||0.459|-0.077|0.1635
71944469|NCT03956862|143411242|SUPERIORITY||Mean Difference (Net)|0.632||||0.1742|TWO_SIDED|95.0|-0.28|1.544|||Mixed Models Analysis||GB001 vs. Placebo|||1.544|-0.280|0.1742
71944470|NCT03956862|143411243|SUPERIORITY||Mean Difference (Net)|0.9||||0.4851|TWO_SIDED|95.0|-1.6|3.4|||ANCOVA||GB001 vs. Placebo|||3.4|-1.6|0.4851
71944471|NCT03956862|143411244|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.3898|TWO_SIDED|95.0|0.136|2.178|||Regression, Cox||GB001 vs Placebo|||2.178|0.136|0.3898
71944472|NCT02129426|143411247|OTHER|t-test comparison of the two groups||||||0.96|||||||t-test, 1 sided|||||||0.96
71944473|NCT02129426|143411248|OTHER|||||||0.52|||||||t-test, 1 sided|||||||0.52
71944474|NCT00850174|143411297|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.48||||||90.0|88.98|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.00|88.98|
71944475|NCT00850174|143411298|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.54||||||90.0|99.19|106.01|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.01|99.19|
71884395|NCT00439946|143288689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||p-value for: CAMPHOR Symptom Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
71944476|NCT00850174|143411299|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.19||||||90.0|98.78|105.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.71|98.78|
71944477|NCT00850174|143411300|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.77||||||90.0|97.03|104.65|||||Results presented for informational purposes only; metabolite not subjected to Bioequivalence criteria.|||104.65|97.03|
71944478|NCT00850174|143411301|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.94||||||90.0|97.75|102.18|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||102.18|97.75|
71944479|NCT00850174|143411302|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.8||||||90.0|97.5|102.15|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||102.15|97.50|
71944480|NCT01363765|143411303|SUPERIORITY_OR_OTHER||notification rate ratio|1.59|||<|0.01|TWO_SIDED|95.0|1.32|1.87||NR were calculated using an aggregated database consisting of 896 strata for laboratory (n=14), study month (n=8), sex (n=2) and age group (n=4: \<15, 15-39, 40-59, and \>=60 years). Poisson regression modeling was used to analyze changes in TB TB NR|Clustered Avareged|Adjustment for municipality, age, sex, and baseline proportion of samples with a positive smear was by a population-averaged quasi-likelihood approach|"The numbers reported in the CONSORT flowchart refer to the diagnostic samples. NR were obtained crosslinking lab and notification databases, denominator was population/year."|cluster-averaged NNR=1.59 (CI95% 1.31-1.88) Absolute numbers informed in table do not allow calculation of notification rates; they are based on population size, not in total numbers and percentages||1.87|1.32|<0.01
71944481|NCT01363765|143411303|SUPERIORITY_OR_OTHER||notification rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.51|1.92|||Mixed Models Analysis|Mixed multi-level model, time-adjusted||Secondary analysis: Mixed multi-level model||1.92|1.51|<0.001
71944482|NCT01363765|143411304|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|-84.07||||||95.0||||||Incremental cost-effectiveness ratio (ICER) per case detected||||||
71944483|NCT01363765|143411305|SUPERIORITY_OR_OTHER||NRR|0.98||||0.923|TWO_SIDED|95.0|0.64|1.32||cluster-averaged adjusted NRR (notification rate ratio, not calculable from number shown, which are a proportion of tests. NRR calculated over a population/year denominator.|Agregated cluster-averaged|||||1.32|0.64|0.923
71944484|NCT01363765|143411306|SUPERIORITY_OR_OTHER||NRR|0.52||||0.004|TWO_SIDED|95.0|0.21|0.84||cluster-averaged adjusted NRR|Agregated cluster-averaged|||||0.84|0.21|0.004
71944485|NCT00635492|143411314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.0001|TWO_SIDED|95.0|1.13|1.19|||Regression, Logistic|||Body Mass Index (BMI) - 1kg/m² higher||1.19|1.13|<0.0001
71944486|NCT00635492|143411315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Regression, Logistic|||Most recent HbA1c at baseline - 1% higher.||0.86|0.69|<0.0001
71944487|NCT00635492|143411316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||<|0.0001|TWO_SIDED|95.0|0.95|0.97|||Regression, Logistic|||Age - 1 year older||0.97|0.95|<0.0001
71944488|NCT00635492|143411317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0083|TWO_SIDED|95.0|1.01|1.1|||Regression, Logistic|||Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No||1.10|1.01|0.0083
71944489|NCT00635492|143411318|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.0141|TWO_SIDED|95.0|0.9|0.99|||Regression, Logistic|||Random blood glucose - 1 mmol/L higher||0.99|0.90|0.0141
71944490|NCT00635492|143411319|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.0107|TWO_SIDED|95.0|0.96|0.99|||Regression, Logistic|||Blood glucose self-monitoring - 1 test/week more||0.99|0.96|0.0107
71944491|NCT00635492|143411320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0193|TWO_SIDED|95.0|1.13|2.46|||Regression, Logistic|||Receipt of diet/exercise advice - Yes vs. No||2.46|1.13|0.0193
71944492|NCT00635492|143411321|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.0138|TWO_SIDED|95.0|0.72|0.96|||Regression, Logistic|||LDL cholesterol - 1 mmol/L higher at baseline||0.96|0.72|0.0138
71944493|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118|||<|0.0001|TWO_SIDED|95.0|1.062|1.177|||Regression, Cox|||HbA1c (%) at baseline||1.177|1.062|<0.0001
71944494|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.001|TWO_SIDED|95.0|0.937|0.985|||Regression, Cox|||DHP barriers to activity subscale at baseline||0.985|0.937|0.001
71944495|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.532|||<|0.001|TWO_SIDED|95.0|1.698|3.777|||Regression, Cox|||Gastrointestinal symptoms: yes vs. no at baseline||3.777|1.698|<0.001
71944496|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.437|||<|0.001|TWO_SIDED|95.0|0.303|0.63|||Regression, Cox|||Insulin regimen: basal/bolus vs. long-acting only||0.630|0.303|<0.001
71944497|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.676||||0.003|TWO_SIDED|95.0|0.523|0.874|||Regression, Cox|||Insulin regimen: mixtures vs. long-acting only||0.874|0.523|0.003
71944498|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.303|TWO_SIDED|95.0|0.175|1.718|||Regression, Cox|||Insulin regimen: other vs. long-acting only||1.718|0.175|0.303
71944499|NCT00635492|143411329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.164|||<|0.001|TWO_SIDED|95.0|1.681|2.785|||Regression, Cox|||Insulin regimen: short-acting only vs. long-acting only||2.785|1.681|<0.001
71944500|NCT00635492|143411330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.463||||0.028|TWO_SIDED|95.0|1.043|2.053|||Regression, Cox|||GI symptoms: yes vs. no at baseline||2.053|1.043|0.028
71944501|NCT00635492|143411330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.002|TWO_SIDED|95.0|0.432|0.834|||Regression, Cox|||EQ-5D index value at baseline||0.834|0.432|0.002
71944502|NCT05169710|143411365|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.857||0.1718|TWO_SIDED|95.0|-9.64|1.75|||Mixed Models Analysis|||||1.75|-9.64|0.1718
71944503|NCT05169710|143411365|SUPERIORITY||Mean Difference (Final Values)|-6.34|STANDARD_ERROR_OF_MEAN|2.837||0.0286|TWO_SIDED|95.0|-11.99|-0.68|||Mixed Models Analysis|||||-0.68|-11.99|0.028600
71944504|NCT05169710|143411366|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.7314|TWO_SIDED|95.0|-0.72|0.51|||Mixed Models Analysis|||||0.51|-0.72|0.7314
71944505|NCT05169710|143411366|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.305||0.3169|TWO_SIDED|95.0|-0.91|0.3|||Mixed Models Analysis|||||0.3|-0.91|0.3169
71944506|NCT02729714|143411367|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71944507|NCT02729714|143411368|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71944508|NCT02729714|143411369|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71944509|NCT02729714|143411370|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71944510|NCT02729714|143411371|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71944511|NCT02729714|143411372|SUPERIORITY|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||||||0.098
71944512|NCT02729714|143411373|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71944513|NCT01686438|143411383|NON_INFERIORITY|The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.|Mean Difference (Net)|-2.03|STANDARD_DEVIATION|1.33||0.138|TWO_SIDED|95.0|-4.63|1.57|||t-test, 1 sided|||||1.57|-4.63|0.138
71944514|NCT01265056|143411399|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71944515|NCT01265056|143411399|SUPERIORITY||||||<|0.04|||||||Regression, Logistic|||||||<0.04
71944516|NCT01265056|143411400|SUPERIORITY||||||<|0.8|||||||t-test, 2 sided|||||||<0.8
71944517|NCT01265056|143411401|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71944518|NCT02601560|143411406|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANCOVA|||||||0.095
71944519|NCT02601560|143411406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71944520|NCT02601560|143411406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71944521|NCT02601560|143411406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71944522|NCT02601560|143411406|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||||||0.440
71944523|NCT02601560|143411406|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71944524|NCT02779543|143411454|EQUIVALENCE|this trial compared the 2 devices to the polysomnography, which is the gold standard|Mean value|368.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71944525|NCT02779543|143411455|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|13.9|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71944526|NCT02779543|143411456|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|106.0|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71944527|NCT02779543|143411457|EQUIVALENCE|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|74.3|||<|0.001|TWO_SIDED||||||ANOVA||compared to gold standard|||||<0.001
71944528|NCT00440297|143411464|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|48.5||||||95.0|38.4|58.7|||||Exact binomial confidence interval.|No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose among subjects who were seronegative at baseline||58.7|38.4|
71944529|NCT00440297|143411464|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|57.7||||||95.0|47.9|67.0|||||Exact binomial confidence interval.|||67.0|47.9|
71944530|NCT00440297|143411465|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|66.7||||||95.0|56.5|75.8|||||Exact binomial confidence interval|||75.8|56.5|
71944531|NCT00440297|143411465|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|69.2||||||95.0|59.4|77.9|||||Exact binomial confidence interval|||77.9|59.4|
71944532|NCT02934347|143411493|SUPERIORITY_OR_OTHER||||||>|0.05||||||Grades analysed were 1, 2 and then 3 and 4 combined because of low frequencies in the latter two grades|Chi-squared, Corrected|Chi-squared for trend||Null hypothesis: no difference in frequency of grade of glottic view between the supine and back-up positions||||>0.05
71944533|NCT02934347|143411494|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|df=3||||||<0.01
71944534|NCT02934347|143411495|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71944535|NCT02934347|143411496|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71944536|NCT06358820|143411500|SUPERIORITY|\>0.15 g/dL change in albumin from baseline to month 6 was anticipated.|Mean Difference (Final Values)|3.77|||<|0.0125|TWO_SIDED|95.0|3.15|4.39||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|Outcome Measure were assessed at baseline and every month during the 6-month study.||4.39|3.15|<0.0125
71944537|NCT06358820|143411501|SUPERIORITY|\>60 mg/L change in prealbumin from baseline to month 6.|Mean Difference (Net)|39.77||||0.0125|TWO_SIDED|95.0|26.66|56.87||A 2-sided P value less than 0.05 was considered statistically significant. However, the significance level (α) was adjusted to 0.0125 to account for multiple testing.|ANOVA||The main analysis was based on LOCF for missing value.|||56.87|26.66|0.0125
71944538|NCT01124175|143411506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|111.95|||||TWO_SIDED|90.0|101.84|123.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.06|101.84|
71944539|NCT01124175|143411507|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|103.61|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.39|103.61|
71944540|NCT01124175|143411508|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.67|||||TWO_SIDED|90.0|103.32|108.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.07|103.32|
71944541|NCT01124175|143411509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||TWO_SIDED|90.0|101.22|110.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.93|101.22|
71944542|NCT01124175|143411510|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|103.07|||||TWO_SIDED|90.0|100.9|105.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.28|100.90|
71944543|NCT01124175|143411511|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.36|||||TWO_SIDED|90.0|100.41|104.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.34|100.41|
71890407|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|1.1||||0.09|TWO_SIDED|95.0|-0.2|2.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||2.5|-0.2|0.090
71890408|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.3|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||1.3|-1.3|0.957
71890409|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|0.7||||0.395|TWO_SIDED|95.0|-0.9|2.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||2.2|-0.9|0.395
71890410|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|-0.9||||0.275|TWO_SIDED|95.0|-2.5|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16||0.7|-2.5|0.275
71890411|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|1.7||||0.039|TWO_SIDED|95.0|0.1|3.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||3.4|0.1|0.039
71890412|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|-0.1||||0.895|TWO_SIDED|95.0|-1.8|1.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||1.6|-1.8|0.895
71890413|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|0.1||||0.914|TWO_SIDED|95.0|-2.1|2.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||2.3|-2.1|0.914
71890414|NCT00348140|143302376|SUPERIORITY||Mean Difference (Net)|-0.9||||0.43|TWO_SIDED|95.0|-3.2|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||1.3|-3.2|0.430
71890415|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|-0.2||||0.583|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.583
71890416|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8||0.6|-1.1|0.631
71890417|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|0.1||||0.812|TWO_SIDED|95.0|-0.8|1.1|||Mixed model for repeated measures|||For Week 16||1.1|-0.8|0.812
71890418|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|0.0||||0.952|TWO_SIDED|95.0|-0.9|1.0|||Mixed model for repeated measures|||For Week 16||1.0|-0.9|0.952
71890419|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|-0.9||||0.117|TWO_SIDED|95.0|-2.1|0.2|||Mixed model for repeated measures|||For Week 24||0.2|-2.1|0.117
71890420|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|-1.0||||0.074|TWO_SIDED|95.0|-2.1|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.1|-2.1|0.074
71890421|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|-1.0||||0.141|TWO_SIDED|95.0|-2.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.3|-2.4|0.141
71890422|NCT00348140|143302377|SUPERIORITY||Mean Difference (Net)|-0.7||||0.331|TWO_SIDED|95.0|-2.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.7|-2.1|0.331
71890423|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|4.1||||0.251|TWO_SIDED|95.0|-2.9|11.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||11.2|-2.9|0.251
71890424|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|5.9||||0.113|TWO_SIDED|95.0|-1.4|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12||13.2|-1.4|0.113
71890425|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|1.6||||0.723|TWO_SIDED|95.0|-7.1|10.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||10.2|-7.1|0.723
71944544|NCT00486863|143411512|SUPERIORITY_OR_OTHER|||||||0.988||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.988
71944545|NCT00486863|143411513|SUPERIORITY_OR_OTHER||||||>|0.999||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||>0.999
71884396|NCT00439946|143288689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84||95.0||||p-value for CAMPHOR Activity Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.84
71884397|NCT00439946|143288689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p-value for CAMPHOR Quality of Life Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
71884398|NCT00439946|143288689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||p-value for CAMPHOR Total Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.22
71884399|NCT00439946|143288690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||p-value for TSQM Effectiveness Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.55
71884400|NCT00439946|143288690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||p-value for TSQM Side-Effects Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
71884401|NCT00439946|143288690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||p-value for TSQM Convenience Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.01
71884402|NCT00439946|143288690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0||||p-value for TSQM Global Satisfaction Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.52
71884403|NCT00049673|143288695|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.18|TWO_SIDED|95.0|0.53|1.14|||Log Rank|||||1.14|0.53|0.18
71884404|NCT00049673|143288696|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|0.0001
71884405|NCT02475681|143288698|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.17|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The primary test to compare PFS between treatment arms was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR (Arm B/Arm A) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.17|0.06|<0.0001
71884406|NCT02475681|143288699|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.13|0.3|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare PFS between treatment Arms A and C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.30|0.13|<0.0001
71884407|NCT02475681|143288700|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|8.3|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS||||22.3|8.3|<0.0001
71884408|NCT02475681|143288700|SUPERIORITY||Risk Difference (RD)|6.9||||0.0763|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel test with adjustment for randomization stratification factors as recorded in IXRS.||||14.9|-1.0|0.0763
71884409|NCT02475681|143288701|SUPERIORITY||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.26|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare TTNT between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||0.26|0.08|<0.0001
71884410|NCT02475681|143288701|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.15|0.4||P-value based on stratified by randomization stratification factors as recorded in IXRS|Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||0.40|0.15|<0.0001
71884411|NCT02475681|143288702|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0577|TWO_SIDED|95.0|0.21|1.06|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||The test to compare overall survival between treatment Arms A versus B and Arms A versus C was the two-sided log-rank test, stratified by randomization stratification factors. The estimate of the HR and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in IXRS.||1.06|0.21|0.0577
71884412|NCT02475681|143288702|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.1556|TWO_SIDED|95.0|0.28|1.27|||Log Rank|Stratified by randomization stratification factors as recorded in IXRS||||1.27|0.28|0.1556
71884413|NCT00132132|143288726|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|This analysis is the per protocol unadjusted value||||||0.03
71944546|NCT00486863|143411514|SUPERIORITY_OR_OTHER|||||||0.926||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.926
71944547|NCT00486863|143411515|SUPERIORITY_OR_OTHER|||||||0.502||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.502
71944548|NCT00486863|143411516|SUPERIORITY_OR_OTHER|||||||0.439||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||0.439
71944549|NCT00486863|143411517|SUPERIORITY_OR_OTHER|||||||0.704||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.704
71944550|NCT00486863|143411518|SUPERIORITY_OR_OTHER|||||||0.517||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.517
71944551|NCT00486863|143411519|SUPERIORITY_OR_OTHER|||||||0.524||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the cord blood.||||0.524
71944552|NCT00486863|143411519|SUPERIORITY_OR_OTHER|||||||0.07||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the heel stick.||||0.070
71944553|NCT00486863|143411520|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||<0.001
71944554|NCT00486863|143411525|SUPERIORITY_OR_OTHER|||||||0.991||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared|||||||0.991
71944555|NCT00355797|143411532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.17|STANDARD_DEVIATION|15.9||0.004|TWO_SIDED|95.0|3.24|15.11|||t-test, 2 sided|||The endpoint will compare the composite percent change in ADL performance for patients while their devices are programmed to CLS and accelerometer pacing modes, using the no rate adaptive pacing mode as the baseline. Null hypothesis: mean composite of percent change for patients with their device programmed to CLS is less than or equal to the mean composite of percent change for the same patients with their device in accelerometer.||15.11|3.24|0.004
71944556|NCT00355797|143411539|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.42|STANDARD_DEVIATION|17.74||0.552|TWO_SIDED|95.0|-6.17|3.33|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device in accelerometer.||3.33|-6.17|0.552
71944557|NCT00355797|143411539|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.91|STANDARD_DEVIATION|21.34||0.505|TWO_SIDED|95.0|-3.8|7.63|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device without rate adaptative pacing.||7.63|-3.80|0.505
71944558|NCT02028715|143411577|SUPERIORITY||Mean Difference (Final Values)|5.55501|STANDARD_ERROR_OF_MEAN|5.96535||0.356|TWO_SIDED|95.0|-6.3904|17.50042|||t-test for Equality of Means|||||17.50042|-6.39040|.356
71944559|NCT02028715|143411578|SUPERIORITY||Median Difference (Final Values)|11.51818|STANDARD_ERROR_OF_MEAN|6.98569||0.105|TWO_SIDED|95.0|-2.49963|25.53599|||t-test for Equality of Means|||||25.53599|-2.49963|.105
71884414|NCT00132132|143288726|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|Age adjusted per protocol||||||0.14
71884415|NCT00132132|143288726|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.||||||0.006
71884416|NCT00132132|143288727|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71884417|NCT02025426|143288728|OTHER|||||||0.547|||||||Kruskal-Wallis|||||||0.547
71884418|NCT02025426|143288730|OTHER|||||||0.925|||||||Kruskal-Wallis|||||||0.925
71884419|NCT02025426|143288731|OTHER|||||||0.498|||||||Kruskal-Wallis|||||||0.498
71884420|NCT02025426|143288732|OTHER|||||||0.201|||||||Kruskal-Wallis|||||||0.201
71884421|NCT02025426|143288733|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71944560|NCT02028715|143411579|SUPERIORITY|||||||0.029|||||||ANOVA|||||||.029
71944561|NCT02028715|143411580|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.643|||||||ANOVA|||||||.643
71944562|NCT02028715|143411581|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.217|||||||ANOVA|||||||.217
71944563|NCT02028715|143411582|SUPERIORITY|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.647|||||||ANOVA|||||||.647
71944564|NCT02028715|143411583|SUPERIORITY||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.587|0.695||||||||.695|-.587|
71944565|NCT04605094|143411602|OTHER||Difference in response rate|-8.62||||0.08|TWO_SIDED|95.0|-17.94|0.71|||Regression, Logistic|||"Treatment difference in IGA responders~Estimates were from a logistic regression model that included treatment group, age as recorded on electronic case report form (eCRF) at screening (\>=12 to \<18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/microliters \[μL\]; \>=300 cells/μL) and baseline value of IGA score."||0.71|-17.94|0.080
71944566|NCT04605094|143411603|OTHER||Difference in response rate|-5.15||||0.384|TWO_SIDED|95.0|-16.67|6.36|||Regression, Logistic|||"Treatment difference in EASI-75 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||6.36|-16.67|0.384
71944567|NCT04605094|143411604|OTHER||Difference in response rate|-8.18||||0.078|TWO_SIDED|95.0|-16.94|0.59|||Regression, Logistic|||"Treatment difference in EASI-90 responders~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline EASI total score."||0.59|-16.94|0.078
71944568|NCT04605094|143411605|OTHER||Difference in response rate|0.69||||0.889|TWO_SIDED|95.0|-8.93|10.32|||Regression, Logistic|||"Treatment difference in Peak Pruritus NRS~Estimates were from a logistic regression model that included treatment group, age as recorded on eCRF at screening (\>=12 to \< 18 years; \>=18 years), blood eosinophils as recorded on eCRF at screening (\<300 cells/μL; \>=300 cells/μL) and baseline Peak Pruritus score."||10.32|-8.93|0.889
71944569|NCT01969747|143411627|SUPERIORITY_OR_OTHER||Adjusted mean|76.09|STANDARD_ERROR_OF_MEAN|8.77|<|0.0001|TWO_SIDED|95.0|58.6|93.59|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 2.5 mg with Placebo||93.59|58.60|<0.0001
71944570|NCT01969747|143411627|SUPERIORITY_OR_OTHER||Adjusted mean|106.39|STANDARD_ERROR_OF_MEAN|8.85|<|0.0001|TWO_SIDED|95.0|88.73|124.05|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 10 mg with Placebo||124.05|88.73|<0.0001
71944571|NCT01969747|143411627|SUPERIORITY_OR_OTHER||Adjusted mean|104.81|STANDARD_ERROR_OF_MEAN|8.99|<|0.0001|TWO_SIDED|95.0|86.88|122.74|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 25 mg with Placebo||122.74|86.88|<0.0001
71944572|NCT00829790|143411657|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|114.49||||||90.0|109.25|119.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||119.98|109.25|
71944573|NCT00829790|143411658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|117.16||||||90.0|110.44|124.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||124.28|110.44|
71944574|NCT00829790|143411659|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|116.7||||||90.0|109.89|123.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123.92|109.89|
71944575|NCT00627016|143411675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.|Wilcoxon (Mann-Whitney)|||||||<0.001
71944576|NCT00627016|143411676|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
71944577|NCT00627016|143411677|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact|||||||<0.001
71944578|NCT04567186|143411695|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.00 logMAR.|Least-square mean|-0.078|STANDARD_ERROR_OF_MEAN|0.0105|||TWO_SIDED|95.0|-0.099|-0.057|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Distance (4 meter)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.099|
71944579|NCT04567186|143411695|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold + 0.17 logMAR.|Least-square mean|-0.059|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.079|-0.039|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Intermediate (64cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||-0.039|-0.079|
71884422|NCT02025426|143288734|OTHER|||||||0.962|||||||Fisher Exact|||||||0.962
71700442|NCT01013753|142916440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.289|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.178|0.4|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||0.400|0.178|<0.0001
71884423|NCT02025426|143288735|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71884424|NCT00452699|143288750|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||<|0.001||95.0|0.07|0.15|||ANCOVA|||||0.15|0.07|<0.001
71884425|NCT02111564|143288763|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.136|TWO_SIDED|95.0|0.52|1.09|||Cox proportional hazards model|||||1.09|0.52|0.136
71884426|NCT02111564|143288764|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.124|TWO_SIDED|95.0|0.84|4.23|||Cox proportional hazards model|||||4.23|0.84|0.124
71884427|NCT02111564|143288765|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.751|TWO_SIDED|95.0|0.62|1.42|||Cox proportional hazards model|||||1.42|0.62|0.751
71884428|NCT02111564|143288766|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.023|TWO_SIDED|95.0|0.22|0.89|||Cox proportional hazards model|||||0.89|0.22|0.023
71738816|NCT01363908|142990425|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5566|TWO_SIDED|||||P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank|||Analysis of 12 to \<18 year olds at 48 weeks||||0.5566
71884429|NCT02111564|143288767|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.033|TWO_SIDED|95.0|0.54|0.97|||Cox proportional hazards model|||||0.97|0.54|0.033
71884430|NCT02111564|143288768|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.073|TWO_SIDED|95.0|0.6|1.02|||Cox proportional hazards model|||||1.02|0.60|0.073
71944580|NCT04567186|143411695|SUPERIORITY|The superiority of the Test lens was concluded if the upper 95% confidence limit of the mean was below the pre-defined threshold +0.17 logMAR.|Least-square Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0111|||TWO_SIDED|95.0|0.04|0.084|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|Near (40cm)|It was calculated that 70 participants would have at least 90% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 1-week follow-up. Sample size was determined using one sample means test for equivalence||0.084|0.040|
71944581|NCT04567186|143411696|SUPERIORITY|The superiority of the Test lens was concluded if the lower confidence limit of the least-square mean was above the threshold of 32 points.|Least-square Mean|55.93|STANDARD_ERROR_OF_MEAN|2.9027|||TWO_SIDED|95.0|49.25|62.61|||Linear Mixed Model|The Kenward and Roger method was used for the denominator degrees of freedom||This study was powered to only test primary hypotheses.||62.61|49.25|
71944582|NCT04567186|143411696|NON_INFERIORITY|A Non-Inferiority margin of 5 points was used.|Least-square mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.4708|||TWO_SIDED|95.0|-5.893|-0.073|||Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom|mean difference was calculated as Test minus Control|This study was powered for only the primary hypotheses.||-0.073|-5.893|
71944583|NCT02331394|143411705|EQUIVALENCE|"The equivalence assumes that the true mean difference between the paired samples is zero. Under this model, all observable differences are explained by random variation.Equality margins are:~Upper Equivalence Margin=1.5 Lower Equivalence Margin=-1.5"|||||<|0.05|||||||t-test, 2 sided|||Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant||||<0.05
71944584|NCT02331394|143411708|SUPERIORITY|Pared t-test was used to evaluate the significance of the change in scores||||||0.02|||||||t-test, 2 sided|||||||0.02
71944585|NCT02481830|143411709|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1144|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.72|0.1144
71944586|NCT02481830|143411710|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|1.16|1.66|||||Hazard Ratio is Nivolumab over Topotecan/Amrubicin using Stratified Cox proportional hazard model|||1.66|1.16|
71944587|NCT02481830|143411711|SUPERIORITY||Estimate of Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.49|1.24|||||Strata adjusted odds ratio (Nivolumab over Topotecan/Amrubicin) using Mantel-Haenszel method|||1.24|0.49|
71944588|NCT02481830|143411712|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin|||1.04|0.73|
71944589|NCT00102440|143411713|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|32.0||||||97.5|23.1|41.3||||||||41.3|23.1|
71944590|NCT00102440|143411713|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|41.0||||||97.5|31.5|49.5||||||||49.5|31.5|
71944591|NCT00102440|143411713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
71944592|NCT00102440|143411713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact|||||||<0.001
71944593|NCT00102440|143411713|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.072
71944594|NCT00102440|143411714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71944595|NCT00102440|143411714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71944596|NCT00102440|143411714|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.031
71944597|NCT00102440|143411715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71944598|NCT00102440|143411715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71944599|NCT00102440|143411715|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.883
71944600|NCT00102440|143411716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71944601|NCT00102440|143411716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||<0.001
71944602|NCT00102440|143411716|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.164
71944603|NCT00102440|143411717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944604|NCT00102440|143411717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944605|NCT00102440|143411717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944606|NCT00102440|143411718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71700443|NCT01013753|142916440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.056||0.0002||95.0|0.099|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.318|0.099|0.0002
71700444|NCT01013753|142916440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.151|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.374|0.151|<0.0001
71700445|NCT01013753|142916440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.205|0.429|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.429|0.205|<0.0001
71700446|NCT01013753|142916440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.315|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.203|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||0.426|0.203|<0.0001
71700447|NCT01013753|142916441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.432|-0.21|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||-0.210|-0.432|<0.0001
71700448|NCT01013753|142916441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.403|-0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.184|-0.403|<0.0001
71700449|NCT01013753|142916441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.436|-0.215|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.215|-0.436|<0.0001
71700450|NCT01013753|142916441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.394|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|-0.505|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||-0.282|-0.505|<0.0001
71884431|NCT02111564|143288769|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.156|TWO_SIDED|95.0|0.58|1.09|||Cox proportional hazards model|||||1.09|0.58|0.156
71700451|NCT01013753|142916441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-0.457|-0.235|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||-0.235|-0.457|<0.0001
71700452|NCT01013753|142916442|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6187||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.981|0.6187
71700453|NCT01013753|142916442|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.996||||0.6022||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.011|0.981|0.6022
71700454|NCT01013753|142916442|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.8641||95.0|0.984|1.014|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.014|0.984|0.8641
71700455|NCT01013753|142916442|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.998||||0.7664||95.0|0.983|1.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.013|0.983|0.7664
71884432|NCT02354703|143288771|SUPERIORITY|||||||0.94||||||a priori significance P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.94
71884433|NCT02354703|143288772|SUPERIORITY|||||||1||||||a priori significance is P\<0.05|Chi-squared|adjusted for baseline value||||||1.00
71884434|NCT02354703|143288773|SUPERIORITY|||||||0.73||||||a priori threshold is P\<0.05|Kruskal-Wallis|adjusted for baseline value||||||0.73
71884435|NCT03468309|143288783|SUPERIORITY|T-test was used to compare means at baseline and 12-weeks|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71884436|NCT03468309|143288784|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71884437|NCT03468309|143288785|SUPERIORITY||||||<|0.05|||||||ANOVA|Assumption of sphericity had been violated X2(2)=13.61, p\<.01 so Huynh-Feldt correction was used||||||<0.05
71884438|NCT03468309|143288786|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71884439|NCT04589988|143288801|SUPERIORITY|||||||0.068||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.068
71890426|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|3.5||||0.482|TWO_SIDED|95.0|-6.3|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24||13.2|-6.3|0.482
71890427|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|1.5||||0.785|TWO_SIDED|95.0|-9.5|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||12.6|-9.5|0.785
71890428|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|2.2||||0.711|TWO_SIDED|95.0|-9.4|13.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36||13.8|-9.4|0.711
71944607|NCT00102440|143411718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944608|NCT00102440|143411718|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||0.006
71944609|NCT00102440|143411719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944610|NCT00102440|143411719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944611|NCT00102440|143411719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA|||||||<0.001
71944612|NCT00102440|143411720|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||>0.999
71944613|NCT00102440|143411720|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.011
71944614|NCT00102440|143411720|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.024
71944615|NCT00102440|143411721|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.083
71944616|NCT00102440|143411721|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.164
71944617|NCT00102440|143411721|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.619
71944618|NCT00102440|143411722|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.080
71944619|NCT00102440|143411722|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.372
71944620|NCT00102440|143411722|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.246
71944621|NCT00102440|143411723|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.674
71944622|NCT00102440|143411723|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
71944623|NCT00102440|143411723|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.411
71944624|NCT00102440|143411724|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.507
71944625|NCT00102440|143411724|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.188
71944626|NCT00102440|143411724|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.362
71944627|NCT00102440|143411725|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.657
71944628|NCT00102440|143411725|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.444
71884440|NCT04589988|143288802|SUPERIORITY|||||||0.063||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.063
71761945|NCT04193189|143025766|SUPERIORITY||Common proportion difference|38.8|||||TWO_SIDED|97.5|28.9|48.1|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 3-alum) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 3-alum at 48 weeks post last scheduled vaccination (Week 72)||48.1|28.9|
71944629|NCT00102440|143411725|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.719
71944630|NCT00102440|143411726|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.999
71944631|NCT00102440|143411726|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.229
71944632|NCT00102440|143411726|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.266
71944633|NCT04627038|143411727|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.51|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.51|
71944634|NCT04627038|143411728|SUPERIORITY||Posterior Mean Difference|0.95|||||TWO_SIDED|95.0|-0.07|1.96|||||Posterior mean difference with 95% credible interval is reported.|||1.96|-0.07|
71944635|NCT04627038|143411729|SUPERIORITY||Posterior Mean Difference|0.24|||||TWO_SIDED|95.0|-0.24|0.72|||||Posterior mean difference with 95% credible interval is reported.|||0.72|-0.24|
71944636|NCT04627038|143411730|SUPERIORITY||Posterior Mean Difference|3.84|||||TWO_SIDED|95.0|0.39|7.2|||||Posterior mean difference with 95% credible interval is reported.|||7.20|0.39|
71944637|NCT04627038|143411731|SUPERIORITY||Posterior Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.48|0.28|||||Posterior mean difference with 95% credible interval is reported.|||0.28|-0.48|
71944638|NCT04627038|143411732|SUPERIORITY||Posterior Mean Difference|0.31|||||TWO_SIDED|95.0|-0.32|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.32|
71944639|NCT04627038|143411733|SUPERIORITY||Posterior Mean Difference|6.24|||||TWO_SIDED|95.0|-1.05|13.56|||||Posterior mean difference with 95% credible interval is reported.|||13.56|-1.05|
71944640|NCT04627038|143411734|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.14|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.14|
71944641|NCT04627038|143411735|SUPERIORITY||Posterior Mean Difference|-0.82|||||TWO_SIDED|95.0|-166.74|165.52|||||Posterior mean difference with 95% credible interval is reported.|||165.52|-166.74|
71944642|NCT04627038|143411736|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.09|0.06|||||Posterior mean difference with 95% credible interval is reported.|||0.06|-0.09|
71944643|NCT02648347|143411785|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.04|0.15||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.15|-0.04|
71884441|NCT04589988|143288803|SUPERIORITY|||||||0.724||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.724
71944644|NCT02648347|143411786|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.205|TWO_SIDED|95.0|0.955|1.412|||Log Rank|||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.412|0.955|=0.2050
71944645|NCT02648347|143411786|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
71944646|NCT02648347|143411787|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.06|0.14||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.14|-0.06|
71944647|NCT02648347|143411788|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.1743|TWO_SIDED|95.0|0.966|1.382|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.382|0.966|=0.1743
71944648|NCT02648347|143411788|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
71944649|NCT02648347|143411789|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.19|||=|0.3154|TWO_SIDED|95.0|0.901|1.564|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.564|0.901|=0.3154
71944650|NCT02648347|143411789|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
71944651|NCT02648347|143411790|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.13|||=|0.5991|TWO_SIDED|95.0|0.808|1.594|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.594|0.808|=0.5991
71944652|NCT02648347|143411790|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
71944653|NCT02648347|143411791|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.4388|TWO_SIDED|95.0|0.902|1.375|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0014 has been reported in this section.||1.375|0.902|=0.4388
71944654|NCT02648347|143411791|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
71944655|NCT01639222|143411802|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|179.72|||||TWO_SIDED|95.0|157.16|205.52|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio \* 100%.|The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.||205.52|157.16|
71944656|NCT01639222|143411803|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|71.77|||||TWO_SIDED|95.0|68.83|74.84|||||Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio \* 100%.|||74.84|68.83|
71944657|NCT01639222|143411804|SUPERIORITY_OR_OTHER||Calcium-Vitamin D/Reference (%)|156.74|||||TWO_SIDED|95.0|121.66|201.93|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio \* 100%.|||201.93|121.66|
71944658|NCT01416584|143411836|SUPERIORITY||Odds Ratio (OR)|1.4||||0.6|TWO_SIDED|95.0|0.4|4.83|||General Estimating Equation (GEE)|||||4.83|0.40|0.60
71944659|NCT01416584|143411836|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED|95.0|0.32|3.73|||General Estimating Equation (GEE)|||||3.73|0.32|0.88
71822677|NCT01866475|143148024|NON_INFERIORITY|This study is designed to test the hypothesis that the IO device has no greater than a 4 percent infection rate. Equivalently, we define success as having at least a 96 percent infection free 48-hour placement.|||||||||||||||||The historical data for the device suggests an infection rate of 0.6 percent per 48 hours or a success rate of 99.4 percent. The formal objective in the design is to reject the one-sided null hypothesis that the success rate is no higher than 96 percent. The analysis will use the exact binomial test and will tolerate a Type I Error rate of 0.05 or less. If we assume a 99.4 percent success rate, the study will have 84 percent power with a sample size of 117 to reject the null hypothesis. If the null hypothesis is rejected, we conclude that the infection rate is less than 4 percent.|||
71884442|NCT04589988|143288804|SUPERIORITY|||||||0.447||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.447
71944660|NCT01416584|143411836|SUPERIORITY||Odds Ratio (OR)|1.27||||0.64|TWO_SIDED|95.0|0.36|4.46|||General Estimating Equation (GEE)|||||4.46|0.36|0.64
71944661|NCT01416584|143411837|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
71884443|NCT04589988|143288805|SUPERIORITY|||||||0.696||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.696
71944662|NCT01416584|143411837|SUPERIORITY||Odds Ratio (OR)|0.73||||0.39|TWO_SIDED|95.0|0.34|1.57|||General Estimating Equation (GEE)|||||1.57|0.34|0.39
71944663|NCT01416584|143411837|SUPERIORITY||Odds Ratio (OR)|1.86||||0.1|TWO_SIDED|95.0|1.53|2.26|||General Estimating Equation (GEE)|||||2.26|1.53|0.10
71944664|NCT01416584|143411838|SUPERIORITY||Odds Ratio (OR)|0.37||||0.02|TWO_SIDED|95.0|0.36|0.38|||General Estimating Equation (GEE)|||||0.38|0.36|0.02
71944665|NCT01416584|143411838|SUPERIORITY||Odds Ratio (OR)|0.39||||0.02|TWO_SIDED|95.0|0.38|0.41|||General Estimating Equation (GEE)|||||0.41|0.38|0.02
71944666|NCT01416584|143411838|SUPERIORITY||Odds Ratio (OR)|1.07||||0.85|TWO_SIDED|95.0|0.2|5.66|||General Estimating Equation (GEE)|||||5.66|0.20|0.85
71944667|NCT01416584|143411839|SUPERIORITY||Odds Ratio (OR)|0.35||||0.01|TWO_SIDED|95.0|0.34|0.35|||General Estimating Equation (GEE)|||||0.35|0.34|0.01
71944668|NCT01416584|143411839|SUPERIORITY||Odds Ratio (OR)|0.41||||0.03|TWO_SIDED|95.0|0.39|0.44|||General Estimating Equation (GEE)|||||0.44|0.39|0.03
71944669|NCT01416584|143411839|SUPERIORITY||Odds Ratio (OR)|0.84||||0.63|TWO_SIDED|95.0|0.42|1.69|||General Estimating Equation (GEE)|||||1.69|0.42|0.63
71944670|NCT01416584|143411840|SUPERIORITY||Odds Ratio (OR)|0.4||||0.01|TWO_SIDED|95.0|0.39|0.4|||General Estimating Equation (GEE)|||||0.40|0.39|0.01
71944671|NCT01416584|143411840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.37|TWO_SIDED|95.0|0.36|1.55|||General Estimating Equation (GEE)|||||1.55|0.36|0.37
71944672|NCT01416584|143411840|SUPERIORITY||Odds Ratio (OR)|0.53||||0.05|TWO_SIDED|95.0|0.28|1.0|||General Estimating Equation (GEE)|||||1.00|0.28|0.05
71944673|NCT00833937|143411862|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|99.7||||||90.0|93.9|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|93.9|
71944674|NCT00833937|143411863|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.8||||||90.0|92.6|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.6|
71944675|NCT00833937|143411864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.9||||||90.0|92.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|92.7|
71944676|NCT02612337|143411990|SUPERIORITY|The target sample size for each was 160 randomized subjects: 80 in each treatment group stratified by gender. The sample size estimate was chosen to achieve more than 90% power with a significance level of 0.05 2-sided to reject the null hypothesis of no treatment difference for the primary endpoint of DVD.|Risk Ratio (RR)|0.907||||0.623|TWO_SIDED|95.0|0.615|1.339|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||1.339|0.615|0.623
71944677|NCT02242201|143411996|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
71944678|NCT02242201|143411996|SUPERIORITY|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||||||0.662
71944679|NCT02242201|143411996|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
71944680|NCT02242201|143411997|SUPERIORITY|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.948
71944681|NCT02242201|143411997|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.880
71944682|NCT02242201|143411997|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Preoperative||||0.802
71944683|NCT02242201|143411997|SUPERIORITY|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.179
71884444|NCT04589988|143288806|SUPERIORITY|||||||0.798||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.798
71944684|NCT02242201|143411997|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.837
71944685|NCT02242201|143411997|SUPERIORITY|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||Intraoperative||||0.142
71944686|NCT02242201|143411997|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.010
71944687|NCT02242201|143411997|SUPERIORITY|||||||0.516|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.516
71944688|NCT02242201|143411997|SUPERIORITY|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||PACU||||0.052
71944689|NCT02242201|143411997|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.840
71944690|NCT02242201|143411997|SUPERIORITY|||||||0.744|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.744
71944691|NCT02242201|143411997|SUPERIORITY|||||||0.501|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU||||0.501
71944692|NCT02242201|143411997|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.358
71944693|NCT02242201|143411997|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.536
71944694|NCT02242201|143411997|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||POD 1||||0.110
71761946|NCT04193189|143025766|SUPERIORITY||Common proportion difference|10.0|||||TWO_SIDED|97.5|3.1|16.4|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 4 weeks post last scheduled vaccination (Week 28 in 3-CpG, Week 8 in 2-CpG)||16.4|3.1|
71944695|NCT02242201|143411997|SUPERIORITY|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.313
71944696|NCT02242201|143411997|SUPERIORITY|||||||0.893|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.893
71944697|NCT02242201|143411997|SUPERIORITY|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||POD 2||||0.232
71944698|NCT02242201|143411998|SUPERIORITY|||||||0.772|||||||Kruskal-Wallis|||||||0.772
71944699|NCT02242201|143411999|SUPERIORITY|||||||0.251|||||||Regression, Cox|||Baseline||||0.251
71944700|NCT02242201|143411999|SUPERIORITY|||||||0.3|||||||Regression, Cox|||3 month follow-up||||0.300
71944701|NCT02242201|143411999|SUPERIORITY|||||||0.113|||||||Regression, Cox|||Baseline vs 3 months||||0.113
71944702|NCT02242201|143411999|SUPERIORITY|||||||0.147|||||||Regression, Cox|||Baseline vs 3 months||||0.147
71944703|NCT02242201|143411999|SUPERIORITY|||||||0.216|||||||Regression, Cox|||Baseline vs 3 months||||0.216
71944704|NCT02242201|143411999|SUPERIORITY|||||||0.968|||||||Regression, Cox|||Baseline vs 3 months||||0.968
71944705|NCT02242201|143412000|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Pain at rest||||0.776
71944706|NCT02242201|143412000|SUPERIORITY|||||||0.447|||||||Kruskal-Wallis|||Pain with movement||||0.447
71944707|NCT02242201|143412001|SUPERIORITY|||||||0.986|||||||ANOVA|||||||0.986
71944708|NCT02242201|143412001|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
71944709|NCT02242201|143412001|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
71944710|NCT02242201|143412001|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months||||<0.001
71944711|NCT02242201|143412002|SUPERIORITY|||||||0.898|||||||ANOVA|||||||0.898
71944712|NCT02242201|143412002|SUPERIORITY|||||||0.112|||||||t-test, 1 sided|||Baseline vs 3 months||||0.112
71944713|NCT02242201|143412002|SUPERIORITY|||||||0.046|||||||t-test, 1 sided|||Baseline vs 3 months||||0.046
71944714|NCT02242201|143412002|SUPERIORITY|||||||0.026|||||||t-test, 1 sided|||Baseline vs 3 months||||0.026
71944715|NCT02242201|143412003|SUPERIORITY|||||||0.843|||||||Fisher Exact|||Operative extremity neurologic changes||||0.843
71944716|NCT02242201|143412003|SUPERIORITY|||||||1|||||||Fisher Exact|||Wound infection||||1.00
71944717|NCT02242201|143412003|SUPERIORITY|||||||1|||||||Fisher Exact|||Fall requiring medical attention||||1.00
71944718|NCT02242201|143412004|SUPERIORITY|||||||1|||||||Fisher Exact|||Pain at rest||||1.00
71944719|NCT02242201|143412004|SUPERIORITY|||||||0.167|||||||Fisher Exact|||Pain with movement||||0.167
71944720|NCT00017953|143412005|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.51|TWO_SIDED|95.0|0.83|1.09|||Regression, Cox|||||1.09|0.83|0.51
71944721|NCT00017953|143412006|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.42|TWO_SIDED|95.0|0.79|1.1|||Regression, Cox|||||1.10|0.79|0.42
71944722|NCT00017953|143412007|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.23|TWO_SIDED|95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.23
71944723|NCT00017953|143412008|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.29|TWO_SIDED|95.0|0.84|1.05|||Regression, Cox|||||1.05|0.84|0.29
71944724|NCT02374853|143412009|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
71944725|NCT02374853|143412010|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
71944726|NCT02374853|143412011|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||.054
71944727|NCT01424644|143412049|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to diphtheria toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination|Vaccine group difference|13.0|||||TWO_SIDED|95.0|9.0|17.0|||Miettinen and Nurminen|||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo||17|9|
71944728|NCT01424644|143412049|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to tetanus toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates \[(MenACWY-CRM+ Tdap+HPV) minus (Placebo+Tdap + HPV)\] was greater than -10%, at 1 month after Tdap vaccination.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||2|-2|
71944729|NCT01424644|143412050|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PT antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the ratio of the GMCs of the MenACWY-CRM +Tdap+HPV group to the Placebo+Tdap + HPV group was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio-Geometric mean conc|1.01|||||TWO_SIDED|95.0|0.89|1.14|||ANOVA|||Non-inferiority of anti-PT immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||1.14|0.89|
71944730|NCT01424644|143412050|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to FHA antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM +Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio- Geometric mean conc|0.84|||||TWO_SIDED|95.0|0.76|0.93|||ANOVA|||Non-inferiority of anti-FHA immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.76|
71944731|NCT01424644|143412050|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to PRN antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference \[(MenACWY-CRM+Tdap+HPV) minus(Placebo+Tdap + HPV)\] was greater than 0.5, at 1 month after vaccination.|Vaccine group ratio-Geometric mean conc|0.82|||||TWO_SIDED|95.0|0.72|0.93|||ANOVA|||Non-inferiority of anti-PRN immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.||0.93|0.72|
71944732|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
71890429|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|4.0||||0.484|TWO_SIDED|95.0|-7.2|15.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.2|-7.2|0.484
71944733|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
71944734|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.3||||||||1.3|1.1|
71822678|NCT01276535|143148072|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
71944735|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
71944736|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.3||||||||1.3|1.0|
71944737|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|1.0|
71944738|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.1|1.4||||||||1.4|1.1|
71944739|NCT01077596|143412056|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
71944740|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.4||||||95.0|0.9|2.2||||||||2.2|0.9|
71660839|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.189||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.189
71944741|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|0.8|2.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||2.0|0.8|
71944742|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|0.8|2.0||||||||2.0|0.8|
71944743|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
71944744|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.3||||||95.0|0.8|2.1||||||||2.1|0.8|
71944745|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.9|0.7|
71944746|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.2||||||95.0|1.2|3.9||||||||3.9|1.2|
71944747|NCT01077596|143412057|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.0||||||95.0|1.1|3.6|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.6|1.1|
71944748|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|3.2|6.3||||||||6.3|3.2|
71944749|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|2.0|4.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.4|2.0|
71944750|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.0||||||95.0|2.8|5.8||||||||5.8|2.8|
71944751|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
71944752|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.4||||||95.0|3.1|6.3||||||||6.3|3.1|
71884445|NCT04589988|143288807|SUPERIORITY|||||||0.135||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, and depression score at baseline.||||0.135
71944753|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.0||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||4.5|1.9|
71944754|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Crude Odds Ratio|4.5||||||95.0|2.8|7.2||||||||7.2|2.8|
71944755|NCT01077596|143412058|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|3.5||||||95.0|2.1|5.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||5.9|2.1|
71944756|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.7|4.1||||||||4.1|1.7|
71944757|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.1||||||95.0|1.3|3.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.4|1.3|
71944758|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.4|3.6||||||||3.6|1.4|
71944759|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
71944760|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.3||||||95.0|1.5|3.7||||||||3.7|1.5|
71944761|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.0|1.1|
71944762|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Crude Odds Ratio|2.6||||||95.0|1.5|4.5||||||||4.5|1.5|
71944763|NCT01077596|143412059|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.2||||||95.0|1.3|3.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||3.9|1.3|
71944764|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.3||||||||1.3|0.5|
71944765|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.7||||||95.0|0.4|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.4|
71944766|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.6||||||95.0|0.4|1.1||||||||1.1|0.4|
71944767|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||||95.0|0.3|1.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.0|0.3|
71944768|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.8||||||95.0|0.5|1.4||||||||1.4|0.5|
71944769|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.8||||||95.0|0.4|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|0.4|
71944770|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.6|2.0||||||||2.0|0.6|
71944771|NCT01077596|143412060|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.6|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status†, previous depression dx, previous IBD‡ diagnosis, OC§ use, HRT/ERT use, and NSAID use.|||1.9|0.6|
71944772|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Crude Odds Ratio|0.9||||||95.0|0.8|1.1||||||||1.1|0.8|
71944773|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
71944774|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
71944775|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
71944776|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.8|1.1||||||||1.1|0.8|
71944777|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.1|0.8|
71944778|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.3||||||||1.3|0.9|
71944779|NCT01077596|143412061|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.9|
71944780|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|1.0|1.3||||||||1.3|1.0|
71944781|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|1.0|
71944782|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.2||||||95.0|1.0|1.4||||||||1.4|1.0|
71944783|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.4|1.0|
71944784|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.1||||||95.0|0.9|1.2||||||||1.2|0.9|
71944785|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.3|0.9|
71944786|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Crude Odds Ratio|1.0||||||95.0|0.9|1.2||||||||1.2|0.9|
71944787|NCT01077596|143412062|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.|||1.2|0.8|
71944788|NCT02024932|143412085|SUPERIORITY_OR_OTHER_LEGACY||Geo-mean ratio|1.037||||0.0164|TWO_SIDED|90.0|1.009|1.065|||ANCOVA|||||1.065|1.009|0.0164
71944789|NCT03020641|143412107|OTHER|t-test|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2347||0.058|TWO_SIDED|95.0||0.1276||the threshold for statistical significance was p\<=0.05.|t-test, 2 sided|||Interleukin 1 (IL1)||0.1276|- 0.8077|0.058
71944790|NCT03020641|143412107|OTHER|Interleukin 6 (IL6)|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.29||0.001|TWO_SIDED|95.0|-1.6|-0.44|||t-test, 2 sided|||||-0.44|-1.60|0.001
71944791|NCT03020641|143412107|OTHER||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.211||0.052|TWO_SIDED|95.0|-0.76|0.81|||t-test, 2 sided|||Interleukin 10||0.81|-0.76|0.052
71944792|NCT03020641|143412107|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.181||0.815|TWO_SIDED|95.0|-0.5|0.22|||t-test, 2 sided|||Vascular Endotelial Grow Factor A||0.22|-0.50|0.815
71944793|NCT03020641|143412107|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.742|TWO_SIDED|95.0|-0.42|0.36|||t-test, 2 sided|||TNF alfa||0.36|-0.42|0.742
71944794|NCT03020641|143412107|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.2||0.603|TWO_SIDED|95.0|-0.36|0.44|||t-test, 2 sided|||Chemokine CXC ligand 2||0.44|-0.36|0.603
71944795|NCT03020641|143412108|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.47|0.65|||t-test, 2 sided|||Matrix metalloproteinase-9||0.65|-0.47|0.600
71944796|NCT03020641|143412108|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028|TWO_SIDED|95.0|0.03|0.97|||t-test, 2 sided|||Plasminogen activator inhibitor-1||0.97|0.030|0.028
71944797|NCT03020641|143412108|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.36||0.807|TWO_SIDED|95.0|-0.64|0.82|||t-test, 2 sided|||E-selectin||0.82|-0.64|0.807
71944798|NCT03020641|143412110|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|4.44||0.862|TWO_SIDED|95.0|-7.49|10.21|||t-test, 2 sided|||||10.21|-7.49|0.862
71944799|NCT01149473|143412133|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.0|||||TWO_SIDED|90.0|98.1|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120|98.1|
71944800|NCT01149473|143412134|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.0|||||TWO_SIDED|90.0|98.8|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106|98.8|
71944801|NCT01149473|143412135|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.0|||||TWO_SIDED|90.0|98.6|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104|98.6|
71944802|NCT01149473|143412136|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|98.8|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108|98.8|
71944803|NCT01149473|143412137|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|95.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.6|
71944804|NCT01149473|143412138|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|98.7|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101|98.7|
71944805|NCT00834067|143412196|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.7||||||90.0|90.1|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|90.1|
71944806|NCT00834067|143412197|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.9|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|99.9|
71944807|NCT00834067|143412198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|99.7|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|99.7|
71944808|NCT00834067|143412199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|96.0|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|96|
71944809|NCT00834067|143412200|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.1|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|99.1|
71944810|NCT00834067|143412201|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.4|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|99.4|
71822679|NCT01276535|143148073|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.||||<0.01
71884446|NCT04589988|143288808|SUPERIORITY|||||||0.291||||||P value shown is for group by time interaction.|Mixed Models Analysis|||A linear mixed effects model was used to assess the effects of time (6-month follow-up versus baseline), group (REBIL versus control) and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for age, sex, race, work status, and depression score at baseline.||||0.291
71884447|NCT04589988|143288809|SUPERIORITY||Incidence rate ratio|0.83||||0.631|TWO_SIDED|95.0|0.4|1.76|||Negative binomial regression||IRR reflects REBIL intervention group versus control group.|Fall rates were compared between REBIL and control groups using negative binomial regression. The model adjusted for age, sex, ace, and depression score at baseline. The null hypothesis was that fall rates do not differ between groups.||1.76|0.40|0.631
71738817|NCT01363908|142990427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0475|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.0475
71944811|NCT00834067|143412202|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|99.8|114.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||114|99.8|
71944812|NCT00834067|143412203|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|99.0|106.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106|99|
71944813|NCT00834067|143412204|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|98.1|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|98.1|
71944814|NCT01513174|143412282|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.124|TWO_SIDED|95.0|1.0|1.92|||Log Rank||||The initial hypothesis estimated that the median PFS for the gefitinib group would be 10 months, while the median PFS for the gefitinib/olaparib group would be 16 months, which implied a hazard ratio (HR) of 1.6.|1.92|1.00|0.124
71944815|NCT01513174|143412283|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3455|TWO_SIDED|95.0|0.806|1.845|||Log Rank|||||1.845|0.806|0.3455
71944816|NCT00467363|143412299|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0984|TWO_SIDED|95.0|0.98|1.22||Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p\<0.05.|Fisher Exact|No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics||The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.||1.22|0.98|0.0984
71944817|NCT00467363|143412300|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0165|TWO_SIDED|95.0|1.02|1.19|||Fisher Exact|||||1.19|1.02|.0165
71944818|NCT00467363|143412301|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.0329|TWO_SIDED|95.0|1.01|1.19|||Fisher Exact|||||1.19|1.01|.0329
71944819|NCT00467363|143412302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.8902|TWO_SIDED|95.0|0.64|1.78|||Fisher Exact|||||1.78|.64|.8902
71944820|NCT00467363|143412303|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.6869|TWO_SIDED|95.0|0.76|1.55|||Fisher Exact|||||1.55|.76|.6869
71944821|NCT00467363|143412304|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.753|TWO_SIDED|95.0|0.19|2.41|||Fisher Exact|||||2.41|.19|.7530
71944822|NCT00467363|143412305|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.15|7.26|||Fisher Exact|||||7.26|.15|1.000
71944823|NCT00467363|143412306|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
71944824|NCT00467363|143412307|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||1|TWO_SIDED|95.0|0.21|5.06|||Fisher Exact|||||5.06|.21|1.000
71660840|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71822680|NCT00562965|143148123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0358|TWO_SIDED|95.0|0.04|1.02|||Cox proportional hazard regression model|A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.||1.02|0.04|0.0358
71822681|NCT00562965|143148124|SUPERIORITY_OR_OTHER|||||||0.0801|TWO_SIDED||||||Fisher Exact|||||||0.0801
71884448|NCT01707693|143288825|SUPERIORITY|repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.||||||0.023||||||P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.|ANCOVA|||||||0.023
71944825|NCT00467363|143412308|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08||||0.7943|TWO_SIDED|95.0|0.67|1.76|||Fisher Exact|||||1.76|.67|.7943
71944826|NCT00467363|143412309|SUPERIORITY_OR_OTHER|||||||0.7802|||||||t-test, 2 sided|||||||.7802
71944827|NCT00467363|143412310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.2603|TWO_SIDED|95.0|0.42|1.23|||Fisher Exact|||||1.23|.42|.2603
71944828|NCT00467363|143412313|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.77|TWO_SIDED|95.0|-0.8|1.4|||Fisher Exact|||||1.4|-0.8|0.77
71944829|NCT02169115|143412314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.7||0.05|TWO_SIDED||||||ANOVA|||||||0.05
71944830|NCT02169115|143412314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|1.8||0.005|TWO_SIDED||||||ANOVA|||||||0.005
71944831|NCT02169115|143412314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|1.4|||TWO_SIDED|||||||||||||
71944832|NCT00836056|143412330|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.75||||||90.0|91.5|104.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.42|91.50|
71944833|NCT00836056|143412331|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.77||||||90.0|91.4|102.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.46|91.40|
71944834|NCT00836056|143412332|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|95.96||||||90.0|90.77|101.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.46|90.77|
71944835|NCT03117296|143412340|OTHER||Rank-Sum|0.05|||<|0.01|TWO_SIDED||||||Fisher Exact|||Univariate 2-group comparisons were performed using χ2 and Fisher's exact tests (when expected cell counts are \<5) for categorical variables, using 2-group t tests and Wilcoxon rank-sum tests (when normality distributions were violated) for continuous variables. Statistical significance was set at P \< .05. All analyses were performed using SAS 9.4 (SAS Institute, Cary, North Carolina).||||<0.01
71944836|NCT01304641|143412352|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71944837|NCT01304641|143412353|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.078||||0.14|TWO_SIDED|95.0|0.976|1.192|||Regression, Cox|||||1.192|0.976|0.140
71944838|NCT01304641|143412354|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71944839|NCT01304641|143412355|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71944840|NCT01304641|143412356|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71944841|NCT01304641|143412357|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71944842|NCT01304641|143412358|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71944843|NCT04544787|143412359|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
71944844|NCT04544787|143412359|OTHER|||||||0.7209|||||||Fisher Exact|||The number of participants with severe solicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe solicited adverse events was 5 out of 100.||||0.7209
71944845|NCT04544787|143412359|OTHER|||||||0.3769|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3769
71944846|NCT04544787|143412359|OTHER|||||||0.3083|||||||Fisher Exact|||The number of participants with severe unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with severe unsolicited adverse events was 17 out of 100.||||0.3083
71944847|NCT04544787|143412359|OTHER|||||||0.4975|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c1 (combined Groups 1 and 2) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||0.4975
71944848|NCT04544787|143412359|OTHER|||||||1|||||||Fisher Exact|||The number of participants with serious unsolicited adverse events in the OPV-vaccinated groups who received nOPV-c2 (combined Groups 3 and 4) was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33) using the two-sided Fisher's exact test. In the UAM1 study, the number of participants with serious unsolicited adverse events was 0 out of 100.||||1.0000
71944849|NCT04544787|143412359|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
71944850|NCT04544787|143412359|OTHER|||||||1|||||||Fisher Exact|||Comparison of severe solicited adverse events||||1.0000
71884449|NCT01707693|143288826|SUPERIORITY|||||||0.011||||||\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|ANCOVA|\* P-value calculated from repeated measures model adjusting for age with a log transformation applied.||||||0.011
71884450|NCT01707693|143288827|OTHER|2-sided Wilcoxon Rank Sum test||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
71944851|NCT04544787|143412359|OTHER|||||||0.1571|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.1571
71944852|NCT04544787|143412359|OTHER|||||||0.296|||||||Fisher Exact|||Comparison of severe unsolicited adverse events||||0.2960
71944853|NCT04544787|143412360|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.9|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 (mOPV2) control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.9|
71660841|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71944854|NCT04544787|143412360|NON_INFERIORITY|The primary immunogenicity endpoint, seroprotection on Day 28 after a single dose of each vaccine candidate, was formally compared with the corresponding endpoint from UAM1 via a non-inferiority test of the difference of each of the novel candidates to the monovalent OPV2 control, mOPV2, each using one-sided α=0.025 and a non-inferiority margin of 10%, computed using two-sided α=0·05 Miettinen and Nurminen score-based CIs for inference.|Difference|2.0|||||TWO_SIDED|95.0|-1.8|7.0||||||The primary immunogenicity endpoint, the seroprotection rate after one dose of either vaccine candidate in the OPV-vaccinated groups (nOPV2 combined groups 1 and 2, and combined groups 3 and 4), was compared with the corresponding endpoint from the historical monovalent OPV2 control study (UAM1, EudraCT # 2015-003325-33). In the UAM1 study, the observed seroprotection rate after a single dose of mOPV2 was 98% (98 out of 100 participants), with a 95% confidence interval (CI) of 93-100%.||7.0|-1.8|
71944855|NCT00465270|143412372|OTHER||Cox Proportional Hazard|0.49||||0.08|TWO_SIDED|95.0|0.22|1.11|||Log Rank|||||1.11|0.22|0.08
71944856|NCT00465270|143412374|OTHER||Cox Proportional Hazard|0.55||||0.046|TWO_SIDED|95.0|0.31|0.999|||Log Rank|||||0.999|0.31|0.046
71944857|NCT01045161|143412417|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.019|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.019
71944858|NCT01045161|143412417|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
71944859|NCT01045161|143412419|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.051||||0.0192|TWO_SIDED|95.0|0.01|0.09|||ANCOVA|||||0.09|0.01|0.0192
71944860|NCT01045161|143412419|SUPERIORITY_OR_OTHER||Least Squares Mean difference|0.072||||0.0012|TWO_SIDED|95.0|0.03|0.12|||ANCOVA|||||0.12|0.03|0.0012
71944861|NCT03686033|143412421|SUPERIORITY||LS Mean difference|1.12|||||TWO_SIDED|90.0|-0.98|3.22||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. Least Square (LS) Mean Difference was calculated for 2.5 mg versus (vs) Placebo only.||3.22|-0.98|
71944862|NCT03686033|143412421|SUPERIORITY||LS Mean difference|-4.17|||||TWO_SIDED|90.0|-6.35|-1.99||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (predose) measurement as a covariate, and subject nested within sequence as a random effect. LS Mean Difference was calculated for 25 mg vs Placebo only.||-1.99|-6.35|
71944863|NCT01085825|143412470|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||.13
71944864|NCT02444715|143412494|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.96
71944865|NCT02444715|143412494|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.03
71944866|NCT02444715|143412495|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.53
71944867|NCT02444715|143412495|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.44
71700456|NCT01013753|142916442|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.003||||0.6757||95.0|0.988|1.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.018|0.988|0.6757
71944868|NCT02444715|143412496|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.76
71944869|NCT02444715|143412496|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71944870|NCT02444715|143412497|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.39
71944871|NCT02444715|143412497|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71944872|NCT02444715|143412498|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.92
71944873|NCT02444715|143412498|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.37
71944874|NCT02444715|143412499|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.78
71944875|NCT02444715|143412499|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.19
71944876|NCT02444715|143412500|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.9
71944877|NCT02444715|143412500|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||H0: no change between baseline and post-intervention||||0.43
71944878|NCT02444715|143412501|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.67
71944879|NCT02444715|143412501|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71944880|NCT02444715|143412502|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.26
71944881|NCT02444715|143412502|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.07
71944882|NCT02444715|143412503|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.06
71944883|NCT02444715|143412503|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.04
71944884|NCT02444715|143412504|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.37
71944885|NCT02444715|143412504|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"||||0.34
71944886|NCT02444715|143412504|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.37
71944887|NCT02444715|143412504|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"||||0.59
71944888|NCT02444715|143412505|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.64
71944889|NCT02444715|143412505|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention||||0.14
71944890|NCT02305758|143412509|SUPERIORITY||Hazard Ratio (HR)|0.939|||||TWO_SIDED|95.0|0.596|1.48||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||1.480|0.596|
71944891|NCT02305758|143412510|SUPERIORITY||Hazard Ratio (HR)|1.261|||||TWO_SIDED|95.0|0.738|2.156||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).||2.156|0.738|
71944892|NCT02305758|143412511|SUPERIORITY||Difference in proportions|-4.62|||||TWO_SIDED|95.0|-21.4|12.1|||Mantel Haenszel|||Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).||12.1|-21.4|
71944893|NCT03616106|143412526|OTHER||Slope|-15.103||||0.859|TWO_SIDED|95.0|-184.574|154.369||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||154.369|-184.574|0.859
71944894|NCT03616106|143412527|OTHER||Slope|28.243||||0.213|TWO_SIDED|95.0|-16.694|73.179||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||73.179|-16.694|0.213
71944895|NCT03616106|143412528|OTHER||Slope|58.993||||0.031|TWO_SIDED|95.0|5.713|112.274||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||112.274|5.713|0.031
71944896|NCT03616106|143412529|OTHER||Slope|-0.0651||||0.053|TWO_SIDED|95.0|-1.313|0.01||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||Viral load variables were log transformed for regression analyses.||0.010|-1.313|0.053
71944897|NCT03616106|143412530|OTHER||Slope|-1.601||||0.008|TWO_SIDED|95.0|-2.761|-0.442||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-0.442|-2.761|0.008
71944898|NCT03616106|143412531|OTHER||Slope|-2.674||||0|TWO_SIDED|95.0|-3.934|-1.415||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||-1.415|-3.934|0.000
71944899|NCT03616106|143412545|OTHER||Slope|2.172||||0|TWO_SIDED|95.0|1.448|2.895||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||2.895|1.448|0.000
71944900|NCT03616106|143412546|OTHER||Slope|2.872||||0|TWO_SIDED|95.0|2.1|3.643||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.643|2.100|0.000
71944901|NCT03616106|143412547|OTHER||Slope|3.166||||0|TWO_SIDED|95.0|2.487|3.846||This p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Regression, Linear|||||3.846|2.487|0.000
71944902|NCT03616106|143412548|OTHER||Z Score|3.25||||0.0011|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0011
71944903|NCT03616106|143412549|OTHER||Z score|3.94||||0.0001|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.0001
71944904|NCT03616106|143412550|OTHER||Z score|4.12||||0|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the threshold for statistical significance was p≤0.05/3 = .017. Please see statistical analysis plan for further details.|Wilcoxon signed rank|||||||0.000
71944905|NCT03616106|143412551|OTHER||Slope|1.935||||0|TWO_SIDED|95.0|1.055|2.815||This p-value was not adjusted for multiple comparisons. The p-value threshold for statistical significance was, therefore, 0.05|Regression, Linear|||||2.815|1.055|0.000
71944906|NCT03616106|143412552|OTHER||Slope|2.123||||0|TWO_SIDED|95.0|1.184|3.062||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.062|1.184|0.000
71944907|NCT03616106|143412553|OTHER||Slope|2.552||||0|TWO_SIDED|95.0|1.612|3.492||The p-value was not adjusted for multiple comparison, therefore, the threshold for statistical significance was 0.05.|Regression, Linear|||||3.492|1.612|0.000
71944908|NCT03616106|143412554|OTHER||Z score|-1.57||||0.1167|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.1167
71944909|NCT03616106|143412555|OTHER||Z score|-2.91||||0.0036|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0036
71944910|NCT03616106|143412556|OTHER||Z score|-3.54||||0.0004|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using the Bonferroni correction. Therefore, the a priori threshold for statistical significance was p≤0.05/3 = .017. For more details please see the statistical plan.|Wilcoxon signed rank|||||||0.0004
71944911|NCT02298322|143412558|OTHER||sucess proportion|91.4|||<|0.0001|TWO_SIDED|95.0|86.2|95.1|||t-test, 1 sided|||||95.1|86.2|<0.0001
71944912|NCT00939003|143412583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71944913|NCT00939003|143412584|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71944914|NCT00939003|143412585|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71944915|NCT00939003|143412586|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
71944916|NCT00939003|143412587|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Chi-squared|||||||0.014
71944917|NCT00939003|143412590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71944918|NCT00939003|143412591|SUPERIORITY_OR_OTHER|||||||0.027|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.027
71944919|NCT00939003|143412592|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||<0.001
71944920|NCT00939003|143412593|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.003
71944921|NCT00939003|143412594|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.||||||0.001
71944922|NCT03880266|143412612|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.244|TWO_SIDED|95.0|-3.76|0.6|||Wilcoxon (Mann-Whitney)|||||0.60|-3.76|0.244
71944923|NCT03880266|143412612|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.168|TWO_SIDED|95.0|-0.65|3.43|||Wilcoxon (Mann-Whitney)|||||3.43|-0.65|0.168
71944924|NCT03880266|143412612|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.699|TWO_SIDED|95.0|-2.39|1.72|||Wilcoxon (Mann-Whitney)|||||1.72|-2.39|0.699
71944925|NCT03880266|143412612|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.833|TWO_SIDED|95.0|-1.94|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-1.94|0.833
71944926|NCT03880266|143412613|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71944927|NCT03880266|143412613|SUPERIORITY|||||||0.589|||||||Fisher Exact|||||||0.589
71944928|NCT03880266|143412613|SUPERIORITY|||||||0.154|||||||Fisher Exact|||||||0.154
71944929|NCT03880266|143412613|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
71944930|NCT03880266|143412614|SUPERIORITY||Mean Difference (Final Values)|-206.5||||0.093|TWO_SIDED|95.0|-451.9|38.9|||t-test, 2 sided|||||38.9|-451.9|0.093
71944931|NCT03880266|143412614|SUPERIORITY||Mean Difference (Final Values)|144.1||||0.186|TWO_SIDED|95.0|-78.6|366.7|||t-test, 2 sided|||||366.7|-78.6|0.186
71944932|NCT03880266|143412614|SUPERIORITY||Mean Difference (Final Values)|-151.7||||0.058|TWO_SIDED|95.0|-309.0|5.7|||t-test, 2 sided|||||5.7|-309.0|0.058
71944933|NCT03880266|143412614|SUPERIORITY||Mean Difference (Final Values)|160.6||||0.186|TWO_SIDED|95.0|-611.2|290.1|||t-test, 2 sided|||||290.1|-611.2|0.186
71944934|NCT03880266|143412615|SUPERIORITY||Mean Difference (Final Values)|-33.62||||0.13|TWO_SIDED|95.0|-78.42|11.17|||t-test, 2 sided|||||11.17|-78.42|0.130
71944935|NCT03880266|143412615|SUPERIORITY||Mean Difference (Final Values)|24.26||||0.518|TWO_SIDED|95.0|-54.62|103.13|||t-test, 2 sided|||||103.13|-54.62|0.518
71944936|NCT03880266|143412615|SUPERIORITY||Mean Difference (Final Values)|-38.14||||0.061|TWO_SIDED|95.0|-78.32|2.03|||t-test, 2 sided|||||2.03|-78.32|0.061
71944937|NCT03880266|143412615|SUPERIORITY||Mean Difference (Final Values)|-39.34||||0.366|TWO_SIDED|95.0|-128.4|49.72|||t-test, 2 sided|||||49.72|-128.40|0.366
71944938|NCT03880266|143412616|SUPERIORITY|||||||0.515|||||||Fisher Exact|||||||0.515
71884451|NCT01707693|143288828|OTHER|counts of stage of change||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Armitage trend test||||||.001
71890430|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|3.4||||0.572|TWO_SIDED|95.0|-8.5|15.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48||15.4|-8.5|0.572
71944939|NCT03880266|143412616|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.560
71761947|NCT04193189|143025766|SUPERIORITY||Common proportion difference|4.8|||||TWO_SIDED|97.5|-0.8|10.5|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 8 weeks post last scheduled vaccination (Week 32 in 3-CpG, Week 12 in 2-CpG)||10.5|-0.8|
71944940|NCT03880266|143412616|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
71944941|NCT03880266|143412616|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.290
71944942|NCT03161405|143412617|OTHER||Geometric mean ratio|1.9827|||||TWO_SIDED|90.0|1.6446|2.3904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||2.3904|1.6446|
71944943|NCT03161405|143412618|OTHER||Geometric mean ratio|1.2914|||||TWO_SIDED|90.0|1.1199|1.4891||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4891|1.1199|
71944944|NCT03161405|143412619|OTHER||Geometric mean ratio|1.2783|||||TWO_SIDED|90.0|1.0965|1.4904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.4904|1.0965|
71944945|NCT00837486|143412620|SUPERIORITY_OR_OTHER||||||=|0.53||||||"one-sided P-value~per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%"|Fisher Exact|||The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.||||=0.53
71944946|NCT00834249|143412634|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71944947|NCT00834249|143412635|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71944948|NCT00834249|143412636|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.71||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71944949|NCT00834249|143412637|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|109.61||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
71944950|NCT00834249|143412638|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.85||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational puposes only.|||||
71944951|NCT00834249|143412639|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.38||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||||
71944952|NCT02718326|143412642|SUPERIORITY||percentage difference|52.3|||<|0.0001|TWO_SIDED|95.0|45.2|59.5|||Cochran-Mantel-Haenszel|||||59.5|45.2|<0.0001
71944953|NCT02718326|143412643|SUPERIORITY||percentage difference|50.1|||<|0.0001|TWO_SIDED|95.0|40.1|60.1|||Cochran-Mantel-Haenszel|||||60.1|40.1|<0.0001
71944954|NCT02718326|143412643|SUPERIORITY||percentage difference|64.8|||<|0.0001|TWO_SIDED|95.0|55.8|73.9|||Cochran-Mantel-Haenszel|||||73.9|55.8|< 0.0001
71944955|NCT02718326|143412644|SUPERIORITY||percentage difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-24.7|-9.9|||Cochran-Mantel-Haenszel|||||-9.9|-24.7|<0.0001
71944956|NCT02718326|143412644|SUPERIORITY||percentage difference|-16.6|||<|0.0001|TWO_SIDED|95.0|-24.2|-9.1|||Cochran-Mantel-Haenszel|||||-9.1|-24.2|<0.0001
71944957|NCT02718326|143412645|SUPERIORITY||percentage difference|-17.3|||=|0.0002|TWO_SIDED|95.0|-26.2|-8.5|||Cochran-Mantel-Haenszel|||||-8.5|-26.2|= 0.0002
71944958|NCT02718326|143412645|SUPERIORITY||percentage difference|-18.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-10.4|||Cochran-Mantel-Haenszel|||||-10.4|-27.5|<0.0001
71944959|NCT02718326|143412648|SUPERIORITY||percentage difference|-6.0||||0.0096|TWO_SIDED|95.0|-10.5|-1.5|||Cochran-Mantel-Haenszel|||||-1.5|-10.5|0.0096
71944960|NCT02718326|143412648|SUPERIORITY||percentage difference|-6.0||||0.0089|TWO_SIDED|95.0|-10.5|-1.6|||Cochran-Mantel-Haenszel|||||-1.6|-10.5|0.0089
71944961|NCT02718326|143412649|SUPERIORITY||Estimate for contrast|0.8||||0.0529|TWO_SIDED|95.0|-0.01|1.6|||ANOVA|||||1.60|-0.01|0.0529
71822682|NCT00562965|143148125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1727|TWO_SIDED|95.0|0.05|1.81|||Cox proportional hazard regression model|Stratified Cox proportional hazard regression model was utilized.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator's choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|||1.81|0.05|0.1727
71944962|NCT02718326|143412649|SUPERIORITY||Estimate for contrast|1.14||||0.0057|TWO_SIDED|95.0|0.33|1.94|||ANOVA|||||1.94|0.33|0.0057
71944963|NCT05025345|143412652|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.013|||||TWO_SIDED|90.0|-0.036|0.011||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||0.011|-0.036|
71944964|NCT05025345|143412653|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71822683|NCT00848211|143148157|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
71822684|NCT00848211|143148159|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
71822685|NCT02444143|143148177|OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
71822686|NCT02444143|143148178|OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
71822687|NCT03582137|143148179|SUPERIORITY||Mean Difference (Net)|-1.8049||||0.3785|TWO_SIDED|95.0|-5.8839|2.2741|||Mixed Models Analysis|||||2.2741|-5.8839|0.3785
71944965|NCT02322593|143412671|SUPERIORITY||Hazard Ratio (HR)|0.83|STANDARD_ERROR_OF_MEAN|0.091||0.039|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.039
71944966|NCT02322593|143412672|SUPERIORITY||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.086||0.0045|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0045
71944967|NCT02322593|143412673|SUPERIORITY||Hazard Ratio (HR)|0.82|STANDARD_ERROR_OF_MEAN|0.078||0.011|TWO_SIDED|95.0|0.7|0.96|||Log Rank|||||0.96|0.70|0.011
71944968|NCT02322593|143412674|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71944969|NCT02322593|143412675|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
71944970|NCT00834418|143412676|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|99.6|116.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116|99.6|
71944971|NCT00834418|143412677|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|95.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|95.2|
71944972|NCT01705574|143412678|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.|Difference in proportions|6.5|||||TWO_SIDED|95.2|0.4|12.6|||||Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.|||12.6|0.4|
71944973|NCT01705574|143412678|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|6.5||||0.034|TWO_SIDED|95.2|0.4|12.6|||Cochran-Mantel-Haenszel|P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.|Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was \> 0, superiority of STB over ATV+RTV+TVD was established.|If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.||12.6|0.4|0.034
71944974|NCT00089661|143412688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||<|0.0001||95.0|4.8|6.3|||ANCOVA|||||6.3|4.8|<0.0001
71944975|NCT02647944|143412702|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71944976|NCT02647944|143412703|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71944977|NCT02647944|143412704|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71944978|NCT02647944|143412705|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||||||0.069
71944979|NCT02647944|143412706|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.054
71944980|NCT02647944|143412707|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71944981|NCT02647944|143412708|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71944982|NCT02647944|143412709|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71944983|NCT02760368|143412731|SUPERIORITY||Risk Difference (RD)|0.378|||<|0.0001|TWO_SIDED|97.5|0.248|0.489|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q2w treatment group at Week 12 are expected to be at least 55%, resulting in an expected difference in ACR20 response rates of 30 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.489|0.248|<0.0001
71944984|NCT02760368|143412731|SUPERIORITY||Risk Difference (RD)|0.445|||<|0.0001|TWO_SIDED|97.5|0.318|0.552|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rates for 64 q4w treatment group at Week 12 are expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 25 percentage points between respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis.||0.552|0.318|<0.0001
71944985|NCT02760368|143412732|SUPERIORITY||Risk Difference (RD)|0.294|||<|0.0001|TWO_SIDED|97.5|0.197|0.389|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 30% in 64 q2w OKZ treatment groups respectively, resulting in an expected difference of 20 percentage points between OKZ q2w treatment group and placebo.||0.389|0.197|<0.0001
71944986|NCT02760368|143412732|SUPERIORITY||Risk Difference (RD)|0.352|||<|0.0001|TWO_SIDED|97.5|0.251|0.449|||Chi-squared|2x2 chi-square test||DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 10% in the placebo group and 22% in 64 mg q4w OKZ treatment group respectively, resulting in an expected difference of 12 percentage points between OKZ q4w treatment group and placebo.||0.449|0.251|<0.0001
71944987|NCT02760368|143412733|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.47|-0.21|||ANCOVA|||||-0.21|-0.47|<0.0001
71944988|NCT02760368|143412733|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|97.5|-0.49|-0.23|||ANCOVA|||||-0.23|-0.49|<0.0001
71700457|NCT01013753|142916443|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.993||||0.4423||95.0|0.975|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.011|0.975|0.4423
71700458|NCT01013753|142916443|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.979||||0.0218||95.0|0.962|0.997|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.997|0.962|0.0218
71944989|NCT02760368|143412734|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.0001|TWO_SIDED|97.5|0.239|0.45|||Chi-squared|2x2 chi-square test||||0.450|0.239|<0.0001
71700459|NCT01013753|142916443|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.977||||0.0109||95.0|0.96|0.995|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.995|0.960|0.0109
71700460|NCT01013753|142916443|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0283||95.0|0.962|0.998|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||0.998|0.962|0.0283
71944990|NCT02760368|143412734|SUPERIORITY||Risk Difference (RD)|0.409|||<|0.0001|TWO_SIDED|97.5|0.296|0.509|||Chi-squared|2x2 chi-square test||||0.509|0.296|<0.0001
71944991|NCT02760368|143412735|SUPERIORITY||Risk Difference (RD)|0.084|||<|0.0002|TWO_SIDED|97.5|0.032|0.151||2x2 chi-square test|Chi-squared|||||0.151|0.032|<0.0002
71944992|NCT02760368|143412735|SUPERIORITY||Risk Difference (RD)|0.077|||<|0.0003|TWO_SIDED|97.5|0.027|0.143||2x2 chi-square test|Chi-squared|||||0.143|0.027|<0.0003
71944993|NCT01860521|143412742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71944994|NCT01860521|143412743|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
71700461|NCT01013753|142916443|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.3085||95.0|0.973|1.009|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.009|0.973|0.3085
71700462|NCT01013753|142916444|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.999||||0.9112||95.0|0.984|1.015|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo|||1.015|0.984|0.9112
71700463|NCT01013753|142916444|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.992||||0.2955||95.0|0.977|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||1.007|0.977|0.2955
71700464|NCT01013753|142916444|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.987||||0.1029||95.0|0.973|1.003|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||1.003|0.973|0.1029
71700465|NCT01013753|142916444|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.991||||0.2552||95.0|0.975|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo|||1.007|0.975|0.2552
71700466|NCT01013753|142916444|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.994||||0.4803||95.0|0.979|1.01|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo|||1.010|0.979|0.4803
71700467|NCT04757636|142916446|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|1.03||0.861409|TWO_SIDED|95.0|-2.2|1.84|||MMRM|||||1.84|-2.20|0.861409
71700468|NCT04757636|142916446|SUPERIORITY||Least Squares Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.029||0.416264|TWO_SIDED|95.0|-2.86|1.18|||MMRM|||||1.18|-2.86|0.416264
71944995|NCT01860521|143412744|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
71944996|NCT01860521|143412745|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.047
71944997|NCT02757105|143412747|SUPERIORITY|||||||0.036|||||||Chi-squared, Corrected|||||||0.036
71944998|NCT02757105|143412748|SUPERIORITY|||||||0.41|||||||Chi-squared, Corrected|||||||0.410
71944999|NCT02757105|143412749|SUPERIORITY|||||||0.081|||||||Chi-squared, Corrected|||||||0.081
71945000|NCT02757105|143412750|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||||||0.042
71945001|NCT02757105|143412751|SUPERIORITY|||||||0.009|||||||Chi-squared, Corrected|||||||0.009
71945002|NCT02757105|143412752|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
71700469|NCT04757636|142916447|SUPERIORITY||Risk Difference (RD)|0.1||||0.981348|TWO_SIDED|95.0|-7.5|7.7|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.7|-7.5|0.981348
71945003|NCT02757105|143412753|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.278|TWO_SIDED|95.0|-7.7|30.6|||Chi-squared, Corrected|||||30.6|-7.7|0.278
71945004|NCT02757105|143412754|SUPERIORITY||Mean Difference (Final Values)|14.5||||0.135|TWO_SIDED|95.0|-3.4|32.5|||Chi-squared, Corrected|||||32.5|-3.4|0.135
71945005|NCT00473330|143412767|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.3|||<|0.0001|TWO_SIDED|95.0|13.8|34.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||34.8|13.8|<0.0001
71945006|NCT00473330|143412767|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.9||||0.0002|TWO_SIDED|95.0|10.7|31.1||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.1|10.7|0.0002
71945007|NCT00473330|143412768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001|TWO_SIDED|95.0|6.1|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.0|6.1|<0.0001
71945008|NCT00473330|143412768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.0001|TWO_SIDED|95.0|6.2|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|6.2|<0.0001
71945009|NCT00473330|143412769|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.4|||<|0.0001|TWO_SIDED|95.0|13.4|35.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||35.4|13.4|<0.0001
71945010|NCT00473330|143412769|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|25.1|||<|0.0001|TWO_SIDED|95.0|14.0|36.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||36.3|14.0|<0.0001
71884452|NCT00143455|143288829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.236||||0.0556||95.0|0.995|1.536|||Cox Proportional Hazard Model|||A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.||1.536|0.995|0.0556
71884453|NCT00143455|143288830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.343||||0.143||95.0|0.905|1.993|||Chi-squared|||||1.993|0.905|0.143
71700470|NCT04757636|142916447|SUPERIORITY||Risk Difference (RD)|-0.7||||0.856|TWO_SIDED|95.0|-8.5|7.0|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||7.0|-8.5|0.856000
71700471|NCT04757636|142916448|SUPERIORITY||Risk Difference (RD)|-1.7||||0.655104|TWO_SIDED|95.0|-8.9|5.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||5.6|-8.9|0.655104
71945011|NCT00473330|143412770|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|8.2||||0.0086|TWO_SIDED|95.0|2.4|14.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||14.1|2.4|0.0086
71884454|NCT00143455|143288831|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|Hazard Ratio (HR)|1.35||||0.011||95.0|1.071|1.701|||Cox Proportional Hazard Model|||||1.701|1.071|0.0110
71884455|NCT00143455|143288832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.354||||0.0831||95.0|0.961|1.908|||Cox Proportional Hazard Model|||||1.908|0.961|0.0831
71945012|NCT00473330|143412770|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.8||||0.0126|TWO_SIDED|95.0|2.0|13.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.6|2.0|0.0126
71700472|NCT04757636|142916448|SUPERIORITY||Risk Difference (RD)|-0.8||||0.821257|TWO_SIDED|95.0|-8.2|6.5|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.5|-8.2|0.821257
71884456|NCT00143455|143288833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.965||||0.7544||95.0|0.771|1.208|||Cox Proportional Hazard Model|||||1.208|0.771|0.7544
71945013|NCT00473330|143412771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.0005|TWO_SIDED|95.0|4.3|15.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||15.1|4.3|0.0005
71884457|NCT00419380|143288855|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Chi-squared|||Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.||||.36
71700473|NCT04757636|142916449|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.234||0.199828|TWO_SIDED|95.0|-0.76|0.16|||MMRM|||||0.16|-0.76|0.199828
71884458|NCT00419380|143288856|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Two by two contingency table was used to compare our outcome, presence/absence of ear drainage, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|Chi-squared|||||||.26
71945014|NCT00473330|143412771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2||||0.0011|TWO_SIDED|95.0|3.3|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||13.0|3.3|0.0011
71945015|NCT00473330|143412772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-107.9|||<|0.0001|TWO_SIDED|95.0|-149.2|-66.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-66.6|-149.2|<0.0001
71945016|NCT00473330|143412772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-119.1|||<|0.0001|TWO_SIDED|95.0|-159.6|-78.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-78.5|-159.6|<0.0001
71945017|NCT00473330|143412773|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-3.0||||0.159|TWO_SIDED|95.0|-6.7|0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.7|-6.7|0.1590
71884459|NCT03099707|143288857|SUPERIORITY||Risk Ratio (RR)|5.2||||0.105|TWO_SIDED|95.0|0.6|43.0|||Fisher Exact|||||43|0.6|0.105
71890431|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|6.8||||0.197|TWO_SIDED|95.0|-3.6|17.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||17.3|-3.6|0.197
71700474|NCT04757636|142916449|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.235||0.188725|TWO_SIDED|95.0|-0.77|0.15|||MMRM|||||0.15|-0.77|0.188725
71945018|NCT00473330|143412773|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-2.5||||0.2721|TWO_SIDED|95.0|-6.5|1.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||1.4|-6.5|0.2721
71945019|NCT00473330|143412774|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|29.5|||<|0.0001|TWO_SIDED|95.0|21.1|38.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||38.0|21.1|<0.0001
71945020|NCT00473330|143412774|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|24.2|||<|0.0001|TWO_SIDED|95.0|16.7|31.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||31.7|16.7|<0.0001
71945021|NCT00473330|143412775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.4|<0.0001
71945022|NCT00473330|143412775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.7|-1.5|<0.0001
71945023|NCT01975948|143412780|OTHER|||||||0.047||||||Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).|Mixed Models Analysis|||One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.||||.047
71945024|NCT01975948|143412781|OTHER|||||||0.15|||||||Mixed Models Analysis|||Our calculations indicated that 50 physicians in each of the two groups will provide \>80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.||||0.15
71945025|NCT01975948|143412781|OTHER||Cohen'd|0.45||||0.03|TWO_SIDED|||||OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance|Mixed Models Analysis|||Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals' attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.||||.03
71945026|NCT01975948|143412782|OTHER|||||||0.993|||||||Mixed Models Analysis|||||||.993
71945027|NCT01975948|143412783|OTHER||Cohen'd|1.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71945028|NCT01975948|143412783|OTHER|||||||0.03|||||||Generalized estimating equations (GEE)|We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.||Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.||||.03
71945029|NCT01975948|143412784|OTHER||Cohen'd|1.44|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71738818|NCT01363908|142990427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.||Analysis of 6 to \<12 year olds at 48 weeks||||0.4410
71945030|NCT01975948|143412784|SUPERIORITY|||||||0.476||||||We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.||||.476
71945031|NCT01975948|143412785|SUPERIORITY||Cohen'd|3.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71945032|NCT01975948|143412785|SUPERIORITY|||||||0.945||||||We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.||||.945
71945033|NCT01975948|143412786|OTHER|||||||0.742|||||||Mixed Models Analysis|||||||.742
71945034|NCT01975948|143412787|OTHER|||||||0.543|||||||Mixed Models Analysis|||||||.543
71945035|NCT01975948|143412788|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||.009
71945036|NCT01975948|143412789|OTHER|||||||0.213|||||||Mixed Models Analysis|||||||.213
71700475|NCT04757636|142916450|SUPERIORITY||Risk Difference (RD)|-0.5||||0.84781|TWO_SIDED|95.0|-5.6|4.6|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||4.6|-5.6|0.847810
71890432|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|7.4||||0.183|TWO_SIDED|95.0|-3.5|18.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12||18.4|-3.5|0.183
71945037|NCT02834663|143412795|SUPERIORITY||Mean Difference (Final Values)|-8.76|STANDARD_DEVIATION|12.521|<|0.0001|TWO_SIDED|95.0|-13.928|-3.592||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||Patients were evaluated for changes in BCVA of the treated eye, from the start of the study till 6 months, until trial completion. After administration of each injection, measurements of BCVA were compared to their respective baseline results. The paired t-test and repeated measures ANOVA was performed for comparative analysis, as all showed normality.||-3.592|-13.928|<0.0001
71945038|NCT02834663|143412796|SUPERIORITY||Mean Difference (Final Values)|110.0|STANDARD_DEVIATION|65.919||0.0001|TWO_SIDED|95.0|82.79|137.21||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||137.210|82.790|0.0001
71945039|NCT02834663|143412797|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_DEVIATION|4.932||0.001|TWO_SIDED|95.0|1.884|5.956||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||5.956|1.884|0.001
71945040|NCT02834663|143412798|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.24||0.0001|TWO_SIDED|95.0|1.3|3.15||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||3.15|1.30|0.0001
71945041|NCT02834663|143412799|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
71945042|NCT02834663|143412800|SUPERIORITY||Mean Difference (Final Values)|5.64|STANDARD_DEVIATION|7.21||0.0001|TWO_SIDED|95.0|2.67|8.62||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||8.62|2.67|0.0001
71945043|NCT02834663|143412801|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_DEVIATION|1.87||0.221|TWO_SIDED|95.0|-0.751|0.795||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||0.795|-0.751|0.221
71945044|NCT01299454|143412819|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.166|||||TWO_SIDED|90.0|0.776|1.751|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.751|0.776|
71945045|NCT01299454|143412819|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.375|||||TWO_SIDED|90.0|0.915|2.066|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.066|0.915|
71945046|NCT01299454|143412819|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.929|||||TWO_SIDED|90.0|0.581|1.488|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.488|0.581|
71700476|NCT04757636|142916450|SUPERIORITY||Risk Difference (RD)|0.9||||0.718699|TWO_SIDED|95.0|-4.2|6.1|||Mantel Haenszel||The rate/rate differences are estimated and compared by aggregating the MH estimates adjusted for the Baseline BCVA category and baseline lesion type read by independent reading center on each of the 100 multiple imputed datasets using Rubin's rule.|||6.1|-4.2|0.718699
71700477|NCT01433913|142916466|OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71945047|NCT01299454|143412820|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.255|||||TWO_SIDED|90.0|0.702|2.244|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.244|0.702|
71945048|NCT01299454|143412820|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.977|3.052|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||3.052|0.977|
71945049|NCT01299454|143412820|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.041|||||TWO_SIDED|90.0|0.506|2.142|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||2.142|0.506|
71945050|NCT01299454|143412821|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.707|1.156|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.156|0.707|
71945051|NCT01299454|143412821|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.665|1.087|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||1.087|0.665|
71945052|NCT01299454|143412821|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.531||||||90.0|0.399|0.705|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance||0.705|0.399|
71700478|NCT01433913|142916467|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71884460|NCT02171611|143288878|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|175.14|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|141.904|216.149|||||Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.149|141.904|
71822688|NCT03582137|143148183|SUPERIORITY||Mean Difference (Net)|-4.4254||||0.2712|TWO_SIDED|95.0|-12.4018|3.551|||Mixed Models Analysis|||||3.5510|-12.4018|0.2712
71700479|NCT01433913|142916468|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71822689|NCT03582137|143148184|SUPERIORITY||Mean Difference (Net)|0.3133||||0.8974|TWO_SIDED|95.0|-4.5414|5.168|||Mixed Models Analysis|||||5.1680|-4.5414|0.8974
71945053|NCT01299454|143412822|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.103|||||TWO_SIDED|90.0|0.774|1.573|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.573|0.774|
71945054|NCT01299454|143412822|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|0.841|1.71|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.710|0.841|
71945055|NCT01299454|143412822|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.524|1.189|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.189|0.524|
71945056|NCT01299454|143412823|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.241|||||TWO_SIDED|90.0|0.719|2.143|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.143|0.719|
71945057|NCT01299454|143412823|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance|Geometric Mean Ratio|1.604|||||TWO_SIDED|90.0|0.942|2.732|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.732|0.942|
71945058|NCT01299454|143412823|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.077|||||TWO_SIDED|90.0|0.54|2.146|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||2.146|0.540|
71945059|NCT01299454|143412824|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.691|1.059|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.059|0.691|
71890433|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|10.0||||0.121|TWO_SIDED|95.0|-2.6|22.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||22.6|-2.6|0.121
71945060|NCT01299454|143412824|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.742|||||TWO_SIDED|90.0|0.599|0.918|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.918|0.599|
71945061|NCT01299454|143412824|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.451|||||TWO_SIDED|90.0|0.352|0.577|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.577|0.352|
71945062|NCT01299454|143412833|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.509|||||TWO_SIDED|90.0|0.346|0.748|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.748|0.346|
71945063|NCT01299454|143412833|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.586|||||TWO_SIDED|90.0|0.399|0.861|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.861|0.399|
71945064|NCT01299454|143412833|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.334|||||TWO_SIDED|90.0|0.214|0.521|||Mixed effect analysis of variance||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.521|0.214|
71945065|NCT01299454|143412834|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.445|1.153|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.153|0.445|
71700480|NCT01433913|142916469|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71660842|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.035
71700481|NCT01433913|142916470|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71700482|NCT01433913|142916474|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71700483|NCT01433913|142916475|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71700484|NCT01433913|142916476|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71700485|NCT01433913|142916477|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71700486|NCT01433913|142916478|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71822690|NCT03582137|143148185|SUPERIORITY||Mean Difference (Net)|0.1505||||0.4643|TWO_SIDED|95.0|-0.2882|0.5892|||Mixed Models Analysis|||||0.5892|-0.2882|0.4643
71700487|NCT03320369|142916499|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71738819|NCT01363908|142990427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0417|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0417
71822691|NCT03582137|143148186|SUPERIORITY||Mean Difference (Net)|-0.1188||||0.6245|TWO_SIDED|95.0|-0.6019|0.3644|||Mixed Models Analysis|||||0.3644|-0.6019|0.6245
71822692|NCT03582137|143148192|SUPERIORITY||Mean Difference (Net)|-0.3341||||0.5921|TWO_SIDED|95.0|-1.5749|0.9068|||Mixed Models Analysis|||||0.9068|-1.5749|0.5921
71822693|NCT03582137|143148193|SUPERIORITY||Mean Difference (Net)|1.9352||||0.1016|TWO_SIDED|95.0|-0.4372|4.3076|||Mixed Models Analysis|||||4.3076|-0.4372|0.1016
71700488|NCT01732692|142916503|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) - control treatment group (split dose) was above a non-inferiority margin of -0.15%.|Treatment Difference|0.0286|||<|0.001|ONE_SIDED|95.0|-0.097||||Exact Farrington - Manning||Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control||||-0.097|<0.001
71700489|NCT03755076|142916508|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71822694|NCT03582137|143148194|SUPERIORITY||Mean Difference (Net)|19.686||||0.0661|TWO_SIDED|95.0|-1.3733|40.7452|||Mixed Models Analysis|||||40.7452|-1.3733|0.0661
71822695|NCT03582137|143148195|SUPERIORITY||Mean Difference (Net)|-3.2214||||0.088|TWO_SIDED|95.0|-6.9381|0.4953|||Mixed Models Analysis|||||0.4953|-6.9381|0.0880
71822696|NCT03582137|143148196|SUPERIORITY||Mean Difference (Net)|-4.9836||||0.2827|TWO_SIDED|95.0|-14.2093|4.2421|||Mixed Models Analysis|||||4.2421|-14.2093|0.2827
71822697|NCT03582137|143148197|SUPERIORITY||Mean Difference (Net)|0.576||||0.7703|TWO_SIDED|95.0|-3.3697|4.5216|||Mixed Models Analysis|||||4.5216|-3.3697|0.7703
71822698|NCT03582137|143148198|SUPERIORITY||Mean Difference (Net)|-0.8834||||0.1874|TWO_SIDED|95.0|-2.2172|0.4504|||Mixed Models Analysis|||||0.4504|-2.2172|0.1874
71700490|NCT03755076|142916509|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71822699|NCT03582137|143148201|SUPERIORITY||Mean Difference (Net)|1.2993||||0.1646|TWO_SIDED|95.0|-0.5533|3.1519|||Mixed Models Analysis|||||3.1519|-0.5533|0.1646
71700491|NCT04167462|142916510|SUPERIORITY||Odds Ratio (OR)|16.49|||<|0.0001|TWO_SIDED|95.0|6.33|42.98|||Cochran-Mantel-Haenszel|||||42.98|6.33|<0.0001
71700492|NCT04167462|142916511|SUPERIORITY||Odds Ratio (OR)|24.29|||<|0.0001|TWO_SIDED|95.0|9.6|61.46|||Cochran-Mantel-Haenszel|||||61.46|9.60|<0.0001
71700493|NCT04167462|142916512|SUPERIORITY||Odds Ratio (OR)|41.19|||<|0.0001|TWO_SIDED|95.0|5.82|291.26|||Cochran-Mantel-Haenszel|||||291.26|5.82|<0.0001
71700494|NCT04167462|142916516|SUPERIORITY||Odds Ratio (OR)|17.27|||<|0.0001|TWO_SIDED|95.0|6.06|49.25|||Cochran-Mantel-Haenszel|||||49.25|6.06|<0.0001
71700495|NCT04167462|142916517|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.0001|TWO_SIDED|95.0|2.19|11.91|||Cochran-Mantel-Haenszel|||||11.91|2.19|<0.0001
71700496|NCT04167462|142916518|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0947|TWO_SIDED|95.0|0.64|53.28|||Cochran-Mantel-Haenszel|||||53.28|0.64|0.0947
71700497|NCT04167462|142916519|SUPERIORITY||Odds Ratio (OR)|4.11||||0.1741|TWO_SIDED|95.0|0.47|35.74|||Cochran-Mantel-Haenszel|||||35.74|0.47|0.1741
71822700|NCT03582137|143148202|SUPERIORITY||Mean Difference (Net)|-1.7519||||0.1093|TWO_SIDED|95.0|-3.9082|0.4045|||Mixed Models Analysis|||||0.4045|-3.9082|0.1093
71822701|NCT03582137|143148203|SUPERIORITY||Mean Difference (Net)|1.3532||||0.1819|TWO_SIDED|95.0|-0.6511|3.3576|||Mixed Models Analysis|||||3.3576|-0.6511|0.1819
71822702|NCT03582137|143148204|SUPERIORITY||Mean Difference (Net)|0.9667||||0.2282|TWO_SIDED|95.0|-0.6287|2.5621|||Mixed Models Analysis|||||2.5621|-0.6287|0.2282
71700498|NCT05383209|142916565|OTHER||Difference in response percentage|-5.0|||||TWO_SIDED|95.0|-24.9|13.4||||||||13.4|-24.9|
71700499|NCT05383209|142916565|OTHER||Slope|-0.2|||||TWO_SIDED|95.0|-20.6|20.6||||||||20.6|-20.6|
71700500|NCT05383209|142916566|OTHER||Difference in response percentage|5.3|||||TWO_SIDED|95.0|-13.2|26.0||||||||26.0|-13.2|
71700501|NCT00149643|142916631|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||Groups' categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.||||<0.05
71700502|NCT06525727|142916640|OTHER||Sensitivity|97.96|||||TWO_SIDED|95.0|89.15|99.95|||Diagnostic accuracy|Diagnostic performance was analyzed in terms of sensitivity, specificity, NPV, PPV and likelihood ratios, all reported with 95% confidence interval||The primary objective of the study was to assess the external validation of the Falls Decision Rule. In this evaluation, patients were categorized into two groups based on the rule: those for whom a CT scan was recommended and those for whom it was not.||99.95|89.15|
71700503|NCT06525727|142916640|OTHER||Specificity|31.96|||||TWO_SIDED|95.0|28.63|35.42|||Diagnostic accuracy|||||35.42|28.63|
71700504|NCT06525727|142916640|OTHER||Negative predictive value|99.59|||||TWO_SIDED|95.0|97.17|99.94|||Diagnostic accuracy|||||99.94|97.17|
71700505|NCT06525727|142916640|OTHER||Positive predictive value|8.59|||||TWO_SIDED|95.0|8.1|9.1|||Diagnostic accuracy|||||9.1|8.1|
71700506|NCT06525727|142916640|OTHER||Negative likelihood ratio|0.06|||||TWO_SIDED|95.0|0.01|0.42|||Diagnostic accuracy|||||0.42|0.01|
71700507|NCT06525727|142916640|OTHER||Positive likelihood ratio|1.44|||||TWO_SIDED|95.0|1.35|1.53|||Diagnostic accuracy|||||1.53|1.35|
71700508|NCT04666298|142916647|SUPERIORITY||Mean Difference (Net)|-56.6|STANDARD_ERROR_OF_MEAN|3.24|<|0.0001|TWO_SIDED|95.0|-64.2|-49.0||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-49.0|-64.2|<.0001
71700509|NCT04666298|142916647|SUPERIORITY||Mean Difference (Net)|-60.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|95.0|-67.6|-54.3||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-54.3|-67.6|<.0001
71700510|NCT04666298|142916647|SUPERIORITY||Mean Difference (Net)|-65.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-72.0|-58.6||One-sided adjusted p-value for multiple comparisons using Dunnett´s multiple t-test|Mixed Models Analysis|||||-58.6|-72.0|<.0001
71700511|NCT00844519|142916663|SUPERIORITY_OR_OTHER|||||||0.17||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.17
71700512|NCT00844519|142916663|SUPERIORITY_OR_OTHER|||||||0.9||||||significant at p\<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD||||0.90
71700513|NCT01311661|142916667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.152|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.152|<0.0001
71700514|NCT01311661|142916667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.111|0.189|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.189|0.111|<0.0001
71700515|NCT01311661|142916667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.19|0.266|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.266|0.190|<0.0001
71890434|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|6.8||||0.291|TWO_SIDED|95.0|-5.8|19.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24||19.3|-5.8|0.291
71700516|NCT01311661|142916667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.17|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.170|<0.0001
71700517|NCT01311661|142916668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.229|0.150|<0.0001
71700518|NCT01311661|142916668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.121|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.199|0.121|<0.0001
71700519|NCT01311661|142916668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.175|0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.253|0.175|<0.0001
71700520|NCT01311661|142916668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.181|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.258|0.181|<0.0001
71700521|NCT01311661|142916669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.153|0.238|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.238|0.153|<0.0001
71700522|NCT01311661|142916669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.187|0.102|<0.0001
71700523|NCT01311661|142916669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.2|0.285|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.285|0.200|<0.0001
71700524|NCT01311661|142916669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.156|0.241|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.241|0.156|<0.0001
71700525|NCT01311661|142916670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.138|0.228|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.228|0.138|<0.0001
71700526|NCT01311661|142916670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.108|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.198|0.108|<0.0001
71700527|NCT01311661|142916670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.222|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.177|0.267|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.267|0.177|<0.0001
71700528|NCT01311661|142916670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.165|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.165|<0.0001
71700529|NCT01311661|142916671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.109|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.203|0.109|<0.0001
71700530|NCT01311661|142916671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.054|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.054|<0.0001
71700531|NCT01311661|142916671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.149|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.243|0.149|<0.0001
71700532|NCT01311661|142916671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.125|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.219|0.125|<0.0001
71700533|NCT01311661|142916672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.091|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.180|0.091|<0.0001
71700534|NCT01311661|142916672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.078|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.167|0.078|<0.0001
71700535|NCT01311661|142916672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.186|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.186|0.098|<0.0001
71822703|NCT03582137|143148205|SUPERIORITY||Mean Difference (Net)|-0.2614||||0.6167|TWO_SIDED|95.0|-1.3002|0.7775|||Mixed Models Analysis|||||0.7775|-1.3002|0.6167
71700536|NCT01311661|142916672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.103|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.191|0.103|<0.0001
71700537|NCT01311661|142916673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.11|0.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.206|0.110|<0.0001
71700538|NCT01311661|142916673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.185|0.090|<0.0001
71700539|NCT01311661|142916673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.123|0.218|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.218|0.123|<0.0001
71700540|NCT01311661|142916673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.087|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.087|<0.0001
71700541|NCT01311661|142916674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.102|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.188|0.102|<0.0001
71822704|NCT03582137|143148206|SUPERIORITY||Mean Difference (Net)|0.3067||||0.8378|TWO_SIDED|95.0|-2.6765|3.2899|||Mixed Models Analysis|||||3.2899|-2.6765|0.8378
71822705|NCT03582137|143148208|SUPERIORITY||Mean Difference (Net)|0.3237||||0.2103|TWO_SIDED|95.0|-0.188|0.8353|||Mixed Models Analysis|||||0.8353|-0.1880|0.2103
71822706|NCT03582137|143148209|SUPERIORITY||Mean Difference (Net)|-0.504||||0.7197|TWO_SIDED|95.0|-3.3015|2.2934|||Mixed Models Analysis|||||2.2934|-3.3015|0.7197
71822707|NCT03582137|143148210|SUPERIORITY||Mean Difference (Net)|2.6158||||0.0686|TWO_SIDED|95.0|-0.2058|5.4373|||Mixed Models Analysis|||||5.4373|-0.2058|0.0686
71822708|NCT03582137|143148211|SUPERIORITY||Mean Difference (Net)|2.7891||||0.2339|TWO_SIDED|95.0|-1.8523|7.4304|||Mixed Models Analysis|||||7.4304|-1.8523|0.2339
71700542|NCT01311661|142916674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.085|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.171|0.085|<0.0001
71700543|NCT01311661|142916674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.113|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.198|0.113|<0.0001
71700544|NCT01311661|142916674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.182|0.098|<0.0001
71700545|NCT01311661|142916675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.084|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.187|0.084|<0.0001
71700546|NCT01311661|142916675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.073|<0.0001
71700547|NCT01311661|142916675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.093|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.195|0.093|<0.0001
71700548|NCT01311661|142916675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.177|0.075|<0.0001
71700549|NCT01311661|142916676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.028||0.0001||95.0|0.055|0.165|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.165|0.055|0.0001
71700550|NCT01311661|142916676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.028||0.001||95.0|0.037|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.037|0.0010
71700551|NCT01311661|142916676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.063|0.172|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.172|0.063|<0.0001
71700552|NCT01311661|142916676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.057|0.166|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.166|0.057|<0.0001
71700553|NCT01311661|142916677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.5|0.757|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.757|0.500|<0.0001
71700554|NCT01311661|142916677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.473|0.73|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.730|0.473|<0.0001
71700555|NCT01311661|142916677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.631|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.503|0.758|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.758|0.503|<0.0001
71700556|NCT01311661|142916677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.685|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|0.558|0.813|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.813|0.558|<0.0001
71700557|NCT01311661|142916678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.665|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.532|0.799|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.799|0.532|<0.0001
71700558|NCT01311661|142916678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.431|0.698|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.698|0.431|<0.0001
71700559|NCT01311661|142916678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.702|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.569|0.835|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.835|0.569|<0.0001
71700560|NCT01311661|142916678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.467|0.732|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.732|0.467|<0.0001
71700561|NCT01311661|142916679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.641|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.516|0.765|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.765|0.516|<0.0001
71700562|NCT01311661|142916679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.453|0.701|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.701|0.453|<0.0001
71700563|NCT01311661|142916679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.544|0.79|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.790|0.544|<0.0001
71700564|NCT01311661|142916679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.519|0.766|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.766|0.519|<0.0001
71700565|NCT01311661|142916680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.591|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.436|0.746|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.746|0.436|<0.0001
71700566|NCT01311661|142916680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.522|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.366|0.677|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.677|0.366|<0.0001
71700567|NCT01311661|142916680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.439|0.749|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.749|0.439|<0.0001
71700568|NCT01311661|142916680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.623|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|0.468|0.777|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.777|0.468|<0.0001
71700569|NCT01311661|142916681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.529|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.396|0.662|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||0.662|0.396|<0.0001
71700570|NCT01311661|142916681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001||95.0|0.277|0.543|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||0.543|0.277|<0.0001
71700571|NCT01311661|142916681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.603|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.471|0.736|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||0.736|0.471|<0.0001
71700572|NCT01311661|142916681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001||95.0|0.349|0.613|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||0.613|0.349|<0.0001
71700573|NCT01311661|142916682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.957|STANDARD_ERROR_OF_MEAN|3.18|<|0.0001||95.0|26.709|39.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||39.206|26.709|<0.0001
71700574|NCT01311661|142916682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.632|STANDARD_ERROR_OF_MEAN|3.167|<|0.0001||95.0|26.409|38.855|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.855|26.409|<0.0001
71700575|NCT01311661|142916682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.66|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|25.448|37.872|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.872|25.448|<0.0001
71700576|NCT01311661|142916682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.895|STANDARD_ERROR_OF_MEAN|3.161|<|0.0001||95.0|22.683|35.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||35.107|22.683|<0.0001
71700577|NCT01311661|142916683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.87|STANDARD_ERROR_OF_MEAN|3.046|<|0.0001||95.0|22.884|34.856|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||34.856|22.884|<0.0001
71700578|NCT01311661|142916683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.056|STANDARD_ERROR_OF_MEAN|3.034|<|0.0001||95.0|26.094|38.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||38.018|26.094|<0.0001
71700579|NCT01311661|142916683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.816|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|25.864|37.767|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||37.767|25.864|<0.0001
71700580|NCT01311661|142916683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.327|STANDARD_ERROR_OF_MEAN|3.028|<|0.0001||95.0|27.375|39.278|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||39.278|27.375|<0.0001
71700581|NCT01311661|142916684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.581|STANDARD_ERROR_OF_MEAN|0.346|<|0.0001||95.0|-2.262|-0.9|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.900|-2.262|<0.0001
71700582|NCT01311661|142916684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.345|<|0.0001||95.0|-2.104|-0.748|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.748|-2.104|<0.0001
71738820|NCT01363908|142990427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0409|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0409
71700583|NCT01311661|142916684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.738|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001||95.0|-2.415|-1.062|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-1.062|-2.415|<0.0001
71700584|NCT01311661|142916684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.689|STANDARD_ERROR_OF_MEAN|0.344||0.0458||95.0|-1.366|-0.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.013|-1.366|0.0458
71700585|NCT01311661|142916685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.391|STANDARD_ERROR_OF_MEAN|19.484|<|0.0001||95.0|135.099|211.682|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||211.682|135.099|<0.0001
71700586|NCT01311661|142916685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|155.097|STANDARD_ERROR_OF_MEAN|19.406|<|0.0001||95.0|116.961|193.234|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||193.234|116.961|<0.0001
71700587|NCT01311661|142916685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.268|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|111.204|187.333|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||187.333|111.204|<0.0001
71700588|NCT01311661|142916685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.441|STANDARD_ERROR_OF_MEAN|19.369|<|0.0001||95.0|112.377|188.505|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||188.505|112.377|<0.0001
71700589|NCT01311661|142916686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.251|STANDARD_ERROR_OF_MEAN|18.997|<|0.0001||95.0|104.916|179.586|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||179.586|104.916|<0.0001
71700590|NCT01311661|142916686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.138|STANDARD_ERROR_OF_MEAN|18.92|<|0.0001||95.0|94.954|169.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||169.322|94.954|<0.0001
71700591|NCT01311661|142916686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.136|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|105.021|179.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||179.251|105.021|<0.0001
71700592|NCT01311661|142916686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.306|STANDARD_ERROR_OF_MEAN|18.885|<|0.0001||95.0|120.192|194.42|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||194.420|120.192|<0.0001
71700593|NCT01311661|142916687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.554|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001||95.0|-0.78|-0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.329|-0.780|<0.0001
71700594|NCT01311661|142916687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.862|-0.412|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.412|-0.862|<0.0001
71700595|NCT01311661|142916687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.813|-0.364|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.364|-0.813|<0.0001
71700596|NCT01311661|142916687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|0.114|<|0.0001||95.0|-0.77|-0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.322|-0.770|<0.0001
71700597|NCT01311661|142916692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.461|-0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo|||-0.253|-0.461|<0.0001
71700598|NCT01311661|142916692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.4|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo|||-0.192|-0.400|<0.0001
71700599|NCT01311661|142916692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo|||-0.198|-0.405|<0.0001
71700600|NCT01311661|142916692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.302|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo|||-0.198|-0.405|<0.0001
71700601|NCT00207740|142916694|SUPERIORITY_OR_OTHER|||||||0.802||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|ANCOVA|||The null hypothesis was that the endpoint for placebo is the same as that for combined 100 mg and 200 mg golimumab. Assuming a standard deviation of 23%, there is 86% power to detect a 10% difference at a 0.05 significance level.||||0.802
71700602|NCT00207740|142916694|SUPERIORITY_OR_OTHER|||||||0.945||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.945
71700603|NCT00207740|142916694|SUPERIORITY_OR_OTHER|||||||0.717||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.717
71700604|NCT00207740|142916694|SUPERIORITY_OR_OTHER|||||||0.357||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.||||0.357
71700605|NCT00207740|142916695|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.286
71700606|NCT00207740|142916695|SUPERIORITY_OR_OTHER|||||||0.742|||||||Wilcoxon (Mann-Whitney)|||||||0.742
71700607|NCT00207740|142916695|SUPERIORITY_OR_OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71700608|NCT00207740|142916695|SUPERIORITY_OR_OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71700609|NCT00207740|142916696|SUPERIORITY_OR_OTHER|||||||0.718||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|Cochran-Mantel-Haenszel|||The null hypothesis was that the number of severe exacerbations per patient from baseline through week 24 for placebo is the same as that in the combined 100 mg and 200 mg golimumab. Assuming 1 severe exacerbation over 6 months per patient in the placebo group, there is 79% power to detect a 35% reduction in the combined 100 mg and 200 mg golimumab group at a 0.05 significance level.||||0.718
71700610|NCT00207740|142916696|SUPERIORITY_OR_OTHER|||||||0.779||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.779
71700611|NCT00207740|142916696|SUPERIORITY_OR_OTHER|||||||0.649||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.649
71700612|NCT00207740|142916696|SUPERIORITY_OR_OTHER|||||||0.256||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.||||0.256
71700613|NCT00207740|142916697|SUPERIORITY_OR_OTHER|||||||0.894|||||||Kruskal-Wallis|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.894
71700614|NCT00207740|142916697|SUPERIORITY_OR_OTHER|||||||0.572|||||||Kruskal-Wallis|||||||0.572
71700615|NCT00207740|142916697|SUPERIORITY_OR_OTHER|||||||0.731|||||||Kruskal-Wallis|||||||0.731
71700616|NCT00207740|142916697|SUPERIORITY_OR_OTHER|||||||0.856|||||||Kruskal-Wallis|||||||0.856
71700617|NCT00207740|142916698|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.273
71700618|NCT00207740|142916698|SUPERIORITY_OR_OTHER|||||||0.382|||||||Cochran-Mantel-Haenszel|||||||0.382
71700619|NCT00207740|142916698|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.350
71700620|NCT00207740|142916698|SUPERIORITY_OR_OTHER|||||||0.341|||||||Cochran-Mantel-Haenszel|||||||0.341
71700621|NCT00207740|142916699|SUPERIORITY_OR_OTHER|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.986
71700622|NCT00207740|142916699|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
71700623|NCT00207740|142916699|SUPERIORITY_OR_OTHER|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||||||0.858
71700624|NCT00207740|142916699|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71700625|NCT00207740|142916700|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||ANOVA|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.||||0.833
71700626|NCT00207740|142916700|SUPERIORITY_OR_OTHER|||||||0.814||95.0|||||ANOVA|||||||0.814
71700627|NCT00207740|142916700|SUPERIORITY_OR_OTHER|||||||0.897||95.0|||||ANOVA|||||||0.897
71700628|NCT00207740|142916700|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||ANOVA|||||||0.726
71700629|NCT02774889|142916730|SUPERIORITY||Rate Ratio|0.72||||0.55|TWO_SIDED|95.0|0.27|2.57|||Fisher Exact|||||2.57|0.27|0.55
71700630|NCT02774889|142916731|SUPERIORITY||Mean Difference (Final Values)|-4.74||||0.001|TWO_SIDED|95.0|-6.61|-2.89|||Fisher Exact|||at 3 months||-2.89|-6.61|0.001
71700631|NCT02774889|142916731|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.001|TWO_SIDED|95.0|-6.47|-1.68|||Fisher Exact|||at 6 months||-1.68|-6.47|0.001
71700632|NCT02774889|142916732|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.05|TWO_SIDED|95.0|0.0|0.16|||Fisher Exact|||3 months||0.16|0.00|0.05
71700633|NCT02774889|142916732|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0003|TWO_SIDED|95.0|0.07|0.22|||Fisher Exact|||6 months||0.22|0.07|0.0003
71700634|NCT02774889|142916733|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.44|||Fisher Exact|||3 months||0.44|-0.40|0.88
71700635|NCT02774889|142916733|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.83|TWO_SIDED|95.0|-0.48|0.37|||Fisher Exact|||6 months||0.37|-0.48|0.83
71700636|NCT02774889|142916734|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.36|TWO_SIDED|95.0|-0.2|0.54|||Fisher Exact|||3 months||0.54|-0.20|0.36
71700637|NCT02774889|142916734|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.14|TWO_SIDED|95.0|-0.11|0.77|||Fisher Exact|||6 months||0.77|-0.11|0.14
71700638|NCT02774889|142916735|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.52|TWO_SIDED|95.0|-0.43|0.85|||Fisher Exact|||3 months||0.85|-0.43|0.52
71700639|NCT02774889|142916735|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.36|TWO_SIDED|95.0|-0.31|0.85|||Fisher Exact|||6 months||0.85|-0.31|0.36
71700640|NCT02774889|142916736|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.43|TWO_SIDED|95.0|-0.58|1.32|||Fisher Exact|||3 months||1.32|-0.58|0.43
71700641|NCT02774889|142916736|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.26|TWO_SIDED|95.0|-0.42|1.49|||Fisher Exact|||6 months||1.49|-0.42|0.26
71700642|NCT02774889|142916737|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.16|TWO_SIDED|95.0|-0.09|0.61|||Fisher Exact|||3 months||0.61|-0.09|0.16
71700643|NCT02774889|142916737|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.29|TWO_SIDED|95.0|-0.55|0.17|||Fisher Exact|||6 months||0.17|-0.55|0.29
71700644|NCT02774889|142916739|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.91|TWO_SIDED|95.0|-2.66|2.4|||Fisher Exact|||3 months||2.40|-2.66|0.91
71700645|NCT02774889|142916739|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.8|TWO_SIDED|95.0|-2.79|2.15|||Fisher Exact|||6 months||2.15|-2.79|0.80
71700646|NCT02774889|142916740|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.54|TWO_SIDED|95.0|-1.44|2.64|||Fisher Exact|||3 months||2.64|-1.44|0.54
71700647|NCT02774889|142916740|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.38|TWO_SIDED|95.0|-1.49|3.81|||Fisher Exact|||6 months||3.81|-1.49|0.38
71700648|NCT02774889|142916742|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.04|TWO_SIDED|95.0|0.06|3.71|||Fisher Exact|||Inside Balance||3.71|0.06|0.04
71700649|NCT02774889|142916742|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.05|TWO_SIDED|95.0|-0.02|3.51|||Fisher Exact|||Outside Balance||3.51|-0.02|0.05
71700650|NCT02774889|142916742|SUPERIORITY||Mean Difference (Final Values)|1.86||||0.06|TWO_SIDED|95.0|-0.08|3.81|||Fisher Exact|||Strength||3.81|-0.08|0.06
71700651|NCT02774889|142916743|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.003|TWO_SIDED|95.0|0.54|2.17|||Fisher Exact|||Balance Exercises at 3 months||2.17|0.54|0.003
71700652|NCT02774889|142916743|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.11|TWO_SIDED|95.0|-0.22|2.24|||Fisher Exact|||Balance Exercises at 6 Months||2.24|-0.22|0.11
71700653|NCT02774889|142916744|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.01|TWO_SIDED|95.0|0.23|1.89|||Fisher Exact|||Strength Exercises at 3 months||1.89|0.23|0.01
71700654|NCT02774889|142916744|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.16|1.67|||Fisher Exact|||Strength Exercises at 6 months||1.67|-0.16|0.11
71700655|NCT02774889|142916745|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.38|TWO_SIDED|95.0|-1.3|3.3|||Fisher Exact|||3 months||3.30|-1.30|0.38
71700656|NCT02774889|142916745|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.02|TWO_SIDED|95.0|0.43|4.73|||Fisher Exact|||6 months||4.73|0.43|0.02
71700657|NCT02774889|142916746|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.33|TWO_SIDED|95.0|-0.33|0.97|||Fisher Exact|||3 months||0.97|-0.33|0.33
71700658|NCT02774889|142916746|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.06|TWO_SIDED|95.0|-0.02|1.27|||Fisher Exact|||6 months||1.27|-0.02|0.06
71700659|NCT02774889|142916747|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.06|TWO_SIDED|95.0|-0.03|1.28|||Fisher Exact|||3 months||1.28|-0.03|0.06
71700660|NCT02774889|142916747|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.59|TWO_SIDED|95.0|-0.45|0.81|||Fisher Exact|||||0.81|-0.45|0.59
71700661|NCT04901624|142916780|SUPERIORITY||Slope|1.19|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|0.42|1.97|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Personal + Loss Protection relative to reference group (Personal + Lottery).|||1.97|0.42|0.003
71700662|NCT04901624|142916780|SUPERIORITY||Slope|1.46|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.68|2.24|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Loss Protection relative to reference group (Personal + Lottery).|||2.24|0.68|<0.001
71700663|NCT04901624|142916780|SUPERIORITY||Slope|1.11|STANDARD_ERROR_OF_MEAN|0.44||0.01|TWO_SIDED|95.0|0.26|1.96|||Mixed Models Analysis||Coefficient for mixed effects regression comparing Time 2 attendance to Time 1 attendance for Family + Lottery relative to reference group (Personal + Lottery).|||1.96|0.26|0.01
71700664|NCT04901624|142916781|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.35||0.409|TWO_SIDED|95.0|-0.98|0.4|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.4|-0.98|0.409
71700665|NCT04901624|142916781|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.098|TWO_SIDED|95.0|-0.09|1.1|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||1.10|-0.09|0.098
71761948|NCT04193189|143025766|SUPERIORITY||Common proportion difference|4.9|||||TWO_SIDED|97.5|-0.8|11.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 24 weeks post last scheduled vaccination (Week 48 in 3-CpG, Week 28 in 2-CpG)||11.2|-0.8|
71700666|NCT04901624|142916781|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.982|TWO_SIDED|95.0|-0.71|0.73|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that money was the biggest barrier to getting the vaccine.||0.73|-0.71|0.982
71700667|NCT04901624|142916781|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.177|TWO_SIDED|95.0|-0.67|0.12|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.12|-0.67|0.177
71700668|NCT04901624|142916781|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.21||0.117|TWO_SIDED|95.0|-0.08|0.74|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.74|-0.08|0.117
71700669|NCT04901624|142916781|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.23||0.809|TWO_SIDED|95.0|-0.39|0.5|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who indicated that their medical provider was the most trusted source of COVID-19 information.||0.50|-0.39|0.809
71700670|NCT04901624|142916781|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.19||0.847|TWO_SIDED|95.0|-0.34|0.41|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.41|-0.34|0.847
71700671|NCT04901624|142916781|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.2||0.993|TWO_SIDED|95.0|-0.39|0.38|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.38|-0.39|0.993
71700672|NCT04901624|142916781|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.22||0.671|TWO_SIDED|95.0|-0.51|0.33|||Regression, Logistic|||Comparison of Time 2 attendance between study arms among respondents who scored below or equal to 5 on the risk aversion scale (scale of 0-10, with 0 being more risk averse and 10 being more risk prone).||0.33|-0.51|0.671
71700673|NCT03100747|142916782|SUPERIORITY||Odds Ratio (OR)|1.21||||0.039|TWO_SIDED|98.3|0.97|1.52||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.52|0.97|0.039
71700674|NCT03100747|142916782|SUPERIORITY||Odds Ratio (OR)|1.91|||<|0.0001|TWO_SIDED|98.3|1.54|2.36||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||2.36|1.54|<0.0001
71700675|NCT03100747|142916782|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.0001|TWO_SIDED|98.3|1.29|1.92||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||1.92|1.29|<0.0001
71700676|NCT03100747|142916787|SUPERIORITY||Odds Ratio (OR)|0.84||||0.094|TWO_SIDED|98.3|0.65|1.08||p-values adjusted for multiple comparisons|Regression, Logistic|||||1.08|0.65|0.094
71700677|NCT03100747|142916787|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|98.3|0.38|0.67||p-value adjusted for multiple comparisons, the a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.67|0.38|<0.0001
71700678|NCT03100747|142916787|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|98.3|0.45|0.8||The a priori threshold for statistical significance (adjusted for multiple comparisons) is 0.0167.|Regression, Logistic|||||0.80|0.45|<0.0001
71700679|NCT03100747|142916792|SUPERIORITY||Odds Ratio (OR)|0.86||||0.24|TWO_SIDED|98.3|0.64|1.17|||Regression, Logistic|||||1.17|0.64|0.24
71700680|NCT03100747|142916792|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0037|TWO_SIDED|98.3|0.49|0.93|||Regression, Logistic|||||0.93|0.49|0.0037
71700681|NCT03100747|142916792|SUPERIORITY||Odds Ratio (OR)|0.78||||0.08|TWO_SIDED|98.3|0.57|1.09|||Regression, Logistic|||||1.09|0.57|0.08
71700682|NCT00770809|142916810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.13
71700683|NCT00770809|142916810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED|||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank|||||||0.072
71700684|NCT03813654|142916832|OTHER|Mixed model analysis with post-hoc tests.|Mean Difference (Final Values)|90.0|STANDARD_DEVIATION|68.7|<|0.05|TWO_SIDED|||||A priori threshold was \<0.05.|Mixed Models Analysis||This is the difference between the control and 8-h Free Sleep Group.|||||<0.05
71700685|NCT03813654|142916837|SUPERIORITY|||||||0.09||||||The groups had unequal variances, so we adjusted for unequal variances when doing the t-test. The a priori threshold for statistical significance was p\<0.05.|t-test, 1 sided|Adjusted for unequal variances between the two groups.||We compared the PVT taken at the start of the final night shift between Group B and those in Group C who slept in the morning and had complete data. Our hypothesis was that Group B would have faster RTs.||||0.09
71700686|NCT01208051|142916848|SUPERIORITY|||||||0.26||||||p-value is stratified by randomization factors.|Log Rank|The conditional power was 7.8%, reaching the futility boundary of \<15%. Patients on the combination arm were then crossed over to cediranib alone.||||||0.26
71700687|NCT01208051|142916849|SUPERIORITY|||||||0.36|||||||Log Rank|||||||0.36
71700688|NCT01208051|142916851|SUPERIORITY|||||||0.8|||||||Log Rank|||||||0.80
71700689|NCT01208051|142916852|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71700690|NCT00973973|142916856|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0262|TWO_SIDED|95.0|-0.45|-0.03|||ANCOVA|Analysis of covariance (ANCOVA) model including baseline value as a covariate.||Comparison of Change from Baseline at Week 4||-0.03|-0.45|0.0262
71700691|NCT00973973|142916856|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.152|<|0.0001|TWO_SIDED|95.0|-1.06|-0.46|||ANCOVA|Analysis of covariance (ANCOVA) model, including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.46|-1.06|< 0.0001
71890435|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|7.0||||0.389|TWO_SIDED|95.0|-8.9|22.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||22.9|-8.9|0.389
71700692|NCT00973973|142916858|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.0163|TWO_SIDED|95.0|-0.38|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.04|-0.38|0.0163
71700693|NCT00973973|142916858|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.101||0.0066|TWO_SIDED|95.0|-0.48|-0.08|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.08|-0.48|0.0066
71700694|NCT00973973|142916860|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.082||0.0089|TWO_SIDED|95.0|-0.38|-0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.06|-0.38|0.0089
71700695|NCT00973973|142916860|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.53|-0.14|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.14|-0.53|0.0011
71700696|NCT00973973|142916862|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.127||0.036|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change form baseline at week 4||-0.02|-0.52|0.0360
71700697|NCT00973973|142916862|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.137||0.007|TWO_SIDED|95.0|-0.65|-0.11|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-0.11|-0.65|0.0070
71700698|NCT00973973|142916868|SUPERIORITY||LS Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|3.939||0.0137|TWO_SIDED|95.0|-17.63|-2.05|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-2.05|-17.63|0.0137
71700699|NCT00973973|142916868|SUPERIORITY||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|3.913||0.0019|TWO_SIDED|95.0|-20.19|-4.7|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-4.70|-20.19|0.0019
71700700|NCT00973973|142916870|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|2.728||0.0244|TWO_SIDED|95.0|-11.61|-0.81|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||-0.81|-11.61|0.0244
71700701|NCT00973973|142916870|SUPERIORITY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|2.549||0.0141|TWO_SIDED|95.0|-11.39|-1.3|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||-1.30|-11.39|0.0141
71700702|NCT00973973|142916872|SUPERIORITY||LS Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|1.821||0.0893|TWO_SIDED|95.0|-6.72|0.49|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4||0.49|-6.72|0.0893
71700703|NCT00973973|142916872|SUPERIORITY||LS Mean Difference|-3.52|STANDARD_ERROR_OF_MEAN|1.938||0.072|TWO_SIDED|95.0|-7.35|0.32|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8||0.32|-7.35|0.0720
71700704|NCT00973973|142916874|SUPERIORITY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.505|<|0.0001|TWO_SIDED|95.0|-3.26|-1.26|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of the change from baseline in CPSSS total score||-1.26|-3.26|< 0.0001
71700705|NCT00973973|142916874|SUPERIORITY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.41|-0.69|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dysmenorrhea score||-0.69|-1.41|< 0.0001
71700706|NCT00973973|142916874|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.143||0.0139|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of non-menstrual pelvic pain score||-0.07|-0.64|0.0139
71700707|NCT00973973|142916874|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.173||0.1052|TWO_SIDED|95.0|-0.63|0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dyspareunia score||0.06|-0.63|0.1052
71700708|NCT00973973|142916874|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.143||0.0081|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of pelvic tenderness score||-0.10|-0.67|0.0081
71700709|NCT00973973|142916874|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.125||0.024|TWO_SIDED|95.0|-0.53|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of induration score||-0.04|-0.53|0.0240
71700710|NCT00973973|142916876|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0012|TWO_SIDED|95.0|-1.2|-0.3|||ANOVA|||Comparison of Patient Global Impression of Change at week 4||-0.3|-1.2|0.0012
71700711|NCT00973973|142916876|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.5|-0.5|||ANOVA|||Comparison of Patient Global Impression of Change at week 8||-0.5|-1.5|0.0002
71700712|NCT00973973|142916878|SUPERIORITY||Difference|19.4||||0.0136|TWO_SIDED|95.0|4.4|34.4|||Pearson chi-squared|||Comparison of response rates at week 4||34.4|4.4|0.0136
71700713|NCT00973973|142916878|SUPERIORITY||Difference|30.2||||0.0007|TWO_SIDED|95.0|13.6|46.7|||Pearson chi-squared|||Comparison of response rates at week 8||46.7|13.6|0.0007
71700714|NCT02832037|142916906|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0145||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0145
71700715|NCT02832037|142916906|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0148||||||Adjusted for multiplicity.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0148
71890436|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|-1.2||||0.865|TWO_SIDED|95.0|-15.0|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36||12.6|-15.0|0.865
71700716|NCT02832037|142916906|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0089||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809 .||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0089
71700717|NCT02832037|142916906|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0038||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0038
71738821|NCT01363908|142990428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9901|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 24 weeks||||0.9901
71738822|NCT01363908|142990428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3039|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to \<12 year olds at 48 weeks||||0.3039
71738823|NCT01363908|142990428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0044|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 24 weeks||||0.0044
71700718|NCT02832037|142916906|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.0085||||||Adjusted for multiplicity.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0085
71700719|NCT02832037|142916906|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.||||||0.228||||||Adjusted for multiplicity.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2280
71700720|NCT02832037|142916906|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.28|STANDARD_ERROR_OF_MEAN|0.8205||0.733|TWO_SIDED|95.0|-1.332|1.892||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.892|-1.332|0.7330
71700721|NCT02832037|142916906|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|0.137|STANDARD_ERROR_OF_MEAN|0.8074||0.8655|TWO_SIDED|95.0|-1.45|1.724||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.724|-1.450|0.8655
71700722|NCT02832037|142916906|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.982|STANDARD_ERROR_OF_MEAN|0.7875||0.0122|TWO_SIDED|95.0|0.434|3.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.530|0.434|0.0122
71700723|NCT02832037|142916906|OTHER|Mixed Model Repeated Measures included fixed, categorical factors of treatment, analysis visit as repeated measures per subject, and treatment by analysis visit interaction, continuous fixed covariate of baseline value and baseline value by analysis visit interaction, subject as random effect, covariance structure= Unstructured.|Difference of adjusted means|1.73|STANDARD_ERROR_OF_MEAN|0.7884||0.0287|TWO_SIDED|95.0|0.181|3.28||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||3.280|0.181|0.0287
71700724|NCT02832037|142916907|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.066||||||P-value is considered nominal.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0660
71700725|NCT02832037|142916907|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.1619||||||P-value is considered nominal.|MCP-Mod linear in log model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1619
71700726|NCT02832037|142916907|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0832||||||P-value is considered nominal.|MCP-Mod Emax model fit|Model assumption: 20% of the maximum effect is achieved at 2 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0832
71738824|NCT01363908|142990428|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0395|TWO_SIDED|||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to \<18 year olds at 48 weeks||||0.0395
71700727|NCT02832037|142916907|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0625||||||P-value is considered nominal.|MCP-Mod Sigmoid Emax model fit|Model assumption: 25% of the maximum effect is achieved at 5 mg and 75% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0625
71700728|NCT02832037|142916907|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.0768||||||P-value is considered nominal.|MCP-Mod logistic model fit|Model assumption: 10% of the maximum effect is achieved at 5 mg and 50% of the maximum effect is achieved at 10 mg of BI 425809.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0768
71700729|NCT02832037|142916907|OTHER|Analysis of covariance (ANCOVA) model estimates were used as input for the MCP-Mod. ANCOVA included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.||||||0.7479||||||P-value is considered nominal.|MCP-Mod beta model fit|Assumption:75% of maximum (max) effect at 2mg, 87.5% of max effect at 5mg,25% of max effect at 25mg,max effect at 10mg BI 425809, scalar parameter=26.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 425809 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, linear in log, Emax, Sigmoid Emax, logistic, and beta) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.7479
71700730|NCT02832037|142916907|OTHER||Difference of adjusted means|1.178|STANDARD_ERROR_OF_MEAN|0.7306||0.11|TWO_SIDED|95.0|-0.258|2.613||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||2.613|-0.258|0.11
71700731|NCT02832037|142916907|OTHER||Difference of adjusted means|-0.837|STANDARD_ERROR_OF_MEAN|0.7224||0.25|TWO_SIDED|95.0|-2.257|0.582||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.582|-2.257|0.25
71700732|NCT02832037|142916907|OTHER||Difference of adjusted means|-0.263|STANDARD_ERROR_OF_MEAN|0.7152||0.71|TWO_SIDED|95.0|-1.669|1.142||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||1.142|-1.669|0.71
71700733|NCT02832037|142916907|OTHER||Difference of adjusted means|-1.072|STANDARD_ERROR_OF_MEAN|0.7125||0.13|TWO_SIDED|95.0|-2.473|0.328||P-value is considered nominal.|ANCOVA|Analysis of covariance (ANCOVA) model included treatment as fixed categorical factor, and baseline score as continuous fixed covariate.|Difference was calculated as BI 425809 - placebo.|Secondary analysis. No formal hypotheses were tested.||0.328|-2.473|0.13
71700734|NCT00770367|142916929|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED||||||t-test, 2 sided|||A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level \<0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.||||.37
71700735|NCT00435942|142916931|NON_INFERIORITY_OR_EQUIVALENCE|The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|Proportion free|0.97|||>|0.8|ONE_SIDED|97.5|0.93||||1-sided z-test|97.5% 1-sided confidence interval||The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|||.93|>0.80
71700736|NCT00920816|142916933|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.767|||||TWO_SIDED|95.0|0.559|1.053||||||First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).||1.053|0.559|
71700737|NCT00920816|142916934|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731|||||TWO_SIDED|95.0|0.506|1.058||||||Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).||1.058|0.506|
71700738|NCT02178956|142916998|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8596|TWO_SIDED|95.0|0.86|1.02||two-sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.02|0.86|0.8596
71738825|NCT00787189|142990487|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Fisher Exact|||||||<0.0005
71738826|NCT05274269|142990506|SUPERIORITY||LS Mean difference|9.2|||<|0.0001|TWO_SIDED|95.0|7.2|11.3|||Mixed Models for Repeated Measures|||||11.3|7.2|< 0.0001
71890437|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|4.2||||0.596|TWO_SIDED|95.0|-11.3|19.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||19.6|-11.3|0.596
71700739|NCT02178956|142916999|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9028|TWO_SIDED|95.0|0.85|1.19||two sided|Log Rank|stratified log rank test stratified by region, time to progression on 1st line therapy and disease measurability.|HR is for napabucuasin + Paclitaxel vs Placebo + Paclitaxel. Based on Cox Proportional hazards model stratified by actual stratification variables including region, time to progression on first line therapy and disease measurability.|||1.19|0.85|0.9028
71700740|NCT02178956|142917000|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7359|TWO_SIDED|95.0|0.6|1.44||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.44|0.60|0.7359
71700741|NCT02178956|142917001|SUPERIORITY||Odds Ratio (OR)|0.93||||0.6555|TWO_SIDED|95.0|0.66|1.3||2-sided|Cochran-Mantel-Haenszel|Based on CMH test stratified by actual stratification variables at baseline including region, and time to progression on first-line therapy.|Odds ratio for napabucasin vs. Placebo. Based on Logistic Regression Model adjusting for actual Stratification variables at baseline including region, and time to progression on first-line therapy.|||1.30|0.66|0.6555
71700742|NCT03769493|142917018|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||< .001
71700743|NCT03769493|142917019|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||.875
71700744|NCT01900314|142917057|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate||||0.16
71700745|NCT01900314|142917058|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Repeated measures ANCOVA with baseline MADRS as co-variate||||0.04
71700746|NCT01104766|142917059|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.0044|TWO_SIDED|95.0|-10.1|-1.9|||ANCOVA|||||-1.9|-10.1|0.0044
71700747|NCT01104766|142917059|SUPERIORITY||Mean Difference (Final Values)|-8.8|||<|0.0001|TWO_SIDED|95.0|-12.9|-4.7|||ANCOVA|||||-4.7|-12.9|<0.0001
71700748|NCT01104766|142917059|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.0008|TWO_SIDED|95.0|-11.0|-2.9|||ANCOVA|||||-2.9|-11.0|0.0008
71700749|NCT01104766|142917060|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0004
71700750|NCT01104766|142917060|SUPERIORITY||Median Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.0001
71700751|NCT01104766|142917060|SUPERIORITY||Median Difference (Final Values)|-0.4||||0.0001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0001
71700752|NCT04225832|142917065|SUPERIORITY||Odds Ratio (OR)|2.51||||0.049|TWO_SIDED|95.0|1.01|6.26||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm||Regression results control for immigration status and length of time in U.S.|6.26|1.01|.049
71890438|NCT00348140|143302378|SUPERIORITY||Mean Difference (Net)|-0.2||||0.975|TWO_SIDED|95.0|-14.7|14.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48||14.2|-14.7|0.975
71700753|NCT04225832|142917066|SUPERIORITY||Odds Ratio (OR)|1.06||||0.83|TWO_SIDED|95.0|0.62|1.81||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Logistic|Regression results control for immigration status and length of time in U.S.|Odds ratio is for indicator of intervention arm|||1.81|0.62|.83
71700754|NCT04225832|142917067|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED|||||a-priori threshold was p\<.05 for two-sided p-value Regression employed nonresponse weights to account for any bias associated with completing any follow-up survey.|Regression, Linear|Regression results control for immigration status, length of time in U.S., and baseline value of the outcome|Slope is adjusted regression coefficient for indicator of intervention arm|"Unlike the observed at any FU primary outcomes which have a single value for each participant, for this outcome we employed a repeated measures style structure with one record for each of up to 3 FU observations. A sandwich estimator (SAS Proc Surveyreg) was employed to account for clustering of observations within participant."||||.14
71700755|NCT03282097|142917095|SUPERIORITY|||||||0.4393|||||||ANCOVA|||||||0.4393
71700756|NCT03282097|142917096|SUPERIORITY|||||||0.2262|||||||ANCOVA|||||||.2262
71700757|NCT03282097|142917097|SUPERIORITY|||||||0.0023|||||||ANCOVA|||||||0.0023
71700758|NCT03282097|142917098|SUPERIORITY|||||||0.6075|||||||Regression, Logistic|||||||0.6075
71700759|NCT03282097|142917099|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<.0001
71700760|NCT03282097|142917100|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
71700761|NCT06001021|142917122|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|-35.55|STANDARD_DEVIATION|17.78||0|TWO_SIDED|90.0|-38.9|-32.19||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||-32.19|-38.90|0.000
71700762|NCT06001021|142917123|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008). Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis.~2008;66(2):150-4. PMID: 18537788"|Mean Difference (Final Values)|23.96|STANDARD_DEVIATION|23.14||0|TWO_SIDED|90.0|19.59|28.32||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||28.32|19.59|0.000
71738827|NCT05274269|142990507|SUPERIORITY||LS Mean difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.5|||Mixed Models for Repeated Measures|||||-24.5|-32.1|< 0.0001
71738828|NCT05274269|142990508|SUPERIORITY||LS Mean difference|19.5|||<|0.0001|TWO_SIDED|95.0|15.5|23.5|||Mixed Models for Repeated Measures|||||23.5|15.5|< 0.0001
71700763|NCT06001021|142917124|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|86.89|STANDARD_DEVIATION|45.43||0|TWO_SIDED|90.0|78.33|95.46||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||95.46|78.33|0.00
71700764|NCT06001021|142917125|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008).~Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. PMID: 18537788."|Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|15.15||0|TWO_SIDED|90.0|19.41|25.12||The significance level is 0.10 with 90% confidence interval|ANCOVA|||||25.12|19.41|0.000
71700765|NCT06001021|142917126|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.44|STANDARD_DEVIATION|7.55||0|TWO_SIDED|90.0|15.02|17.87||The significance level is 0.10 with 90% confidence interval|ANCOVA|||Physical Domain of Quality of Life||17.87|15.02|0.000
71700766|NCT06001021|142917126|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|16.6|STANDARD_DEVIATION|7.62||0|TWO_SIDED|90.0|15.16|18.04||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Psychological Domain of Quality of Life||18.04|15.16|0.000
71700767|NCT06001021|142917126|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|8.26|STANDARD_DEVIATION|3.96||0|TWO_SIDED|90.0|7.52|9.01||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||Social Domain of Quality of Life||9.01|7.52|0.000
71700768|NCT06001021|142917126|SUPERIORITY|"In the Superiority Trial, the statistical test aims to show that the treatment group gives better results than the control group. In an equivalence trial, the statistical test aims to show that two treatments are not too different in characteristics, where not too different is defined in a clinical manner (Lesaffre, 2008)."|Mean Difference (Final Values)|23.73|STANDARD_DEVIATION|11.07||0|TWO_SIDED|90.0|21.64|25.81||The significance level is 0.10 with 90% confidence interval.|ANCOVA|||||25.81|21.64|0.000
71700769|NCT05473039|142917147|SUPERIORITY|||||||0.2629|||||||Wilcoxon (Mann-Whitney)|||||||0.2629
71700770|NCT05473039|142917148|SUPERIORITY|||||||0.3582|||||||Wilcoxon (Mann-Whitney)|||||||0.3582
71700771|NCT05473039|142917149|SUPERIORITY|||||||0.2187|||||||Wilcoxon (Mann-Whitney)|||||||0.2187
71700772|NCT05473039|142917150|SUPERIORITY|||||||0.3005|||||||Wilcoxon (Mann-Whitney)|||||||0.3005
71700773|NCT05473039|142917151|SUPERIORITY|||||||0.0314|||||||Wilcoxon (Mann-Whitney)|||||||0.0314
71700774|NCT05473039|142917152|SUPERIORITY|||||||0.9214|||||||t-test, 2 sided|||||||0.9214
71700775|NCT05473039|142917152|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||0.042
71700776|NCT05473039|142917152|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fasting glucose at the start of COH compared to baseline fasting glucose.||||<0.001
71700777|NCT05473039|142917153|SUPERIORITY|||||||0.59695|||||||t-test, 2 sided|||||||0.59695
71700778|NCT05473039|142917153|SUPERIORITY|||||||0.466503|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.466503
71700779|NCT05473039|142917153|SUPERIORITY|||||||0.959877|||||||t-test, 2 sided|||AST at the start of COH compared to baseline AST.||||0.959877
71700780|NCT05473039|142917154|SUPERIORITY|||||||0.06281|||||||t-test, 2 sided|||||||0.062810
71700781|NCT05473039|142917154|SUPERIORITY|||||||0.417757|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.417757
71700782|NCT05473039|142917154|SUPERIORITY|||||||0.968525|||||||t-test, 2 sided|||ALT at the start of COH compared to baseline ALT.||||0.968525
71700783|NCT05473039|142917155|SUPERIORITY|||||||0.686488|||||||t-test, 2 sided|||||||0.686488
71700784|NCT05473039|142917155|SUPERIORITY|||||||0.39512|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.395120
71700785|NCT05473039|142917155|SUPERIORITY|||||||0.127135|||||||t-test, 2 sided|||Cholesterol at the start of COH compared to baseline cholesterol.||||0.127135
71700786|NCT05473039|142917156|SUPERIORITY|||||||0.257496|||||||t-test, 2 sided|||||||0.257496
71700787|NCT02535312|142917161|OTHER|||||||0.08|||||||Log Rank|||||||0.08
71700788|NCT02535312|142917162|OTHER|||||||0.15|||||||Log Rank|||||||0.15
71700789|NCT03034967|142917185|OTHER|Emax|Median Posterior Difference|0.08|||||TWO_SIDED|90.0|0.0|0.66|||||Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.66|0.00|
71700790|NCT03034967|142917185|OTHER|Emax|Median Posterior Difference|0.61|||||TWO_SIDED|90.0|0.0|1.52|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||1.52|0.00|
71700791|NCT03034967|142917185|OTHER|Emax|Median Posterior Difference|1.25|||||TWO_SIDED|90.0|0.43|1.97|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.97|0.43|
71700792|NCT03034967|142917185|OTHER|Emax|Median Posterior Difference|1.34|||||TWO_SIDED|90.0|0.72|2.03|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||2.03|0.72|
71700793|NCT03034967|142917185|OTHER|Emax|Median Posterior Difference|1.38|||||TWO_SIDED|90.0|0.79|2.07|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||2.07|0.79|
71700794|NCT03034967|142917186|OTHER|Emax|Median Posterior Difference|0.09|||||TWO_SIDED|90.0|0.0|0.42|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.42|0.00|
71700795|NCT03034967|142917186|OTHER|Emax|Median Posterior Difference|0.43|||||TWO_SIDED|90.0|0.0|0.87|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.87|0.00|
71700796|NCT03034967|142917186|OTHER|Emax|Median Posterior Difference|0.68|||||TWO_SIDED|90.0|0.23|1.08|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||1.08|0.23|
71700797|NCT03034967|142917186|OTHER|Emax|Median Posterior Difference|0.72|||||TWO_SIDED|90.0|0.37|1.1|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||1.10|0.37|
71700798|NCT03034967|142917186|OTHER|Emax|Median Posterior Difference|0.73|||||TWO_SIDED|90.0|0.4|1.12|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||1.12|0.40|
71700799|NCT03034967|142917187|OTHER|Emax|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|0.0|0.16|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.||0.16|0.00|
71700800|NCT03034967|142917187|OTHER|Emax|Median Posterior Difference|0.12|||||TWO_SIDED|90.0|0.0|0.43|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model||0.43|0.00|
71700801|NCT03034967|142917187|OTHER|Emax|Median Posterior Difference|0.38|||||TWO_SIDED|90.0|0.04|0.61|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.||0.61|0.04|
71700802|NCT03034967|142917187|OTHER|Emax|Median Posterior Difference|0.42|||||TWO_SIDED|90.0|0.21|0.64|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.||0.64|0.21|
71700803|NCT03034967|142917187|OTHER|Emax|Median Posterior Difference|0.45|||||TWO_SIDED|90.0|0.26|0.66|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.||0.66|0.26|
71700804|NCT03034967|142917188|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.21|0.23|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|Log-linear model.||0.23|-0.21|
71700805|NCT03034967|142917188|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.23|0.25|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|Log-linear model||0.25|-0.23|
71700806|NCT03034967|142917188|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.27|0.29|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|Log-linear model||0.29|-0.27|
71700807|NCT03034967|142917188|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.28|0.3|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|Log-linear model||0.30|-0.28|
71700808|NCT03034967|142917188|OTHER|Log-linear|Median Posterior Difference|0.01|||||TWO_SIDED|90.0|-0.29|0.31|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|Log-linear model||0.31|-0.29|
71700809|NCT03034967|142917195|OTHER||Odds Ratio (OR)|1.71||||0.089|TWO_SIDED|90.0|1.02|2.86||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.86|1.02|0.089
71700810|NCT03034967|142917195|OTHER||Odds Ratio (OR)|1.05||||0.881|TWO_SIDED|90.0|0.62|1.79||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.79|0.62|0.881
71700811|NCT03034967|142917195|OTHER||Odds Ratio (OR)|0.87||||0.674|TWO_SIDED|90.0|0.51|1.48||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.48|0.51|0.674
71700812|NCT03034967|142917195|OTHER||Odds Ratio (OR)|0.92||||0.804|TWO_SIDED|90.0|0.54|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||1.58|0.54|0.804
71700813|NCT03034967|142917195|OTHER||Odds Ratio (OR)|1.01||||0.987|TWO_SIDED|90.0|0.59|1.71||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.71|0.59|0.987
71700814|NCT03034967|142917197|OTHER||Median Posterior Hazard Ratio|1.2|||||TWO_SIDED|90.0|0.5|2.6|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.|2.6|0.5|
71700815|NCT03034967|142917197|OTHER||Median Posterior Hazard Ratio|1.0|||||TWO_SIDED|90.0|0.4|2.4|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.4|0.4|
71761949|NCT04193189|143025766|SUPERIORITY||Common proportion difference|7.2|||||TWO_SIDED|97.5|0.7|14.2|||||Common SPR proportion (expressed as percentage of participants) difference (3-CpG minus 2-CpG) with two-sided 97.5% Newcombe confidence interval stratified by sex at birth and diabetes status; Mantel-Haenszel weights were used.|Comparison of Group A 3-CpG and 2-CpG at 48 weeks post last scheduled vaccination (Week 72 in 3-CpG, Week 52 in 2-CpG)||14.2|0.7|
71700816|NCT03034967|142917197|OTHER||Median Posterior Hazard Ratio|1.4|||||TWO_SIDED|90.0|0.6|3.2|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|3.2|0.6|
71700817|NCT03034967|142917197|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|1.0|4.3|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.3|1.0|
71700818|NCT03034967|142917197|OTHER||Median Posterior Hazard Ratio|2.0|||||TWO_SIDED|90.0|0.9|4.5|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|4.5|0.9|
71700819|NCT03034967|142917200|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|1.0|2.2|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.|2.2|1.0|
71700820|NCT03034967|142917200|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.8|1.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.7|0.8|
71700821|NCT03034967|142917200|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|1.6|0.7|
71700822|NCT03034967|142917200|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.4|||||TWO_SIDED|90.0|1.0|2.1|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.1|1.0|
71700823|NCT03034967|142917200|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.1|2.3|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.3|1.1|
71700824|NCT03034967|142917201|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.5|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.5|0.7|
71700825|NCT03034967|142917201|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.9|||||TWO_SIDED|90.0|0.7|5.8|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.8|0.7|
71700826|NCT03034967|142917201|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||TWO_SIDED|90.0|0.7|5.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|5.6|0.7|
71884461|NCT02171611|143288878|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|154.84|STANDARD_ERROR_OF_MEAN|46.6|||TWO_SIDED|90.0|127.425|188.161|||||Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||188.161|127.425|
71700827|NCT03034967|142917201|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|2.3|||||TWO_SIDED|90.0|0.9|6.9|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|6.9|0.9|
71700828|NCT03034967|142917201|OTHER|Bayesian proportional hazards model|Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.2|2.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (\<=1/\>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.|2.7|0.2|
71700829|NCT03034967|142917204|OTHER||Odds Ratio (OR)|1.51||||0.208|TWO_SIDED|90.0|0.88|2.59||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||2.59|0.88|0.208
71738829|NCT05274269|142990509|SUPERIORITY||LS Mean difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.24|0.69|||Mixed Models for Repeated Measures|||||0.69|0.24|< 0.0001
71700830|NCT03034967|142917204|OTHER||Odds Ratio (OR)|1.27||||0.482|TWO_SIDED|90.0|0.73|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||2.20|0.73|0.482
71700831|NCT03034967|142917204|OTHER||Odds Ratio (OR)|1.47||||0.239|TWO_SIDED|90.0|0.86|2.53||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||2.53|0.86|0.239
71700832|NCT03034967|142917204|OTHER||Odds Ratio (OR)|1.31||||0.426|TWO_SIDED|90.0|0.75|2.26||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.26|0.75|0.426
71700833|NCT03034967|142917204|OTHER||Odds Ratio (OR)|0.9||||0.763|TWO_SIDED|90.0|0.52|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||1.58|0.52|0.763
71700834|NCT03034967|142917206|OTHER||Odds Ratio (OR)|1.01||||0.973|TWO_SIDED|90.0|0.58|1.76||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|||1.76|0.58|0.973
71700835|NCT03034967|142917206|OTHER||Odds Ratio (OR)|0.93||||0.825|TWO_SIDED|90.0|0.53|1.63||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|||1.63|0.53|0.825
71700836|NCT03034967|142917206|OTHER||Odds Ratio (OR)|0.95||||0.887|TWO_SIDED|90.0|0.55|1.66||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|||1.66|0.55|0.887
71700837|NCT03034967|142917206|OTHER||Odds Ratio (OR)|1.21||||0.567|TWO_SIDED|90.0|0.69|2.13||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|||2.13|0.69|0.567
71700838|NCT03034967|142917206|OTHER||Odds Ratio (OR)|1.26||||0.501|TWO_SIDED|90.0|0.72|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|||2.20|0.72|0.501
71700839|NCT04279483|142917217|SUPERIORITY|Linear mixed effects|Slope|-0.64|STANDARD_ERROR_OF_MEAN|1.95||0.74|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.74
71700840|NCT04279483|142917217|SUPERIORITY|Linear mixed effects|Slope|-0.84|STANDARD_ERROR_OF_MEAN|2.12||0.69|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.69
71700841|NCT04279483|142917218|SUPERIORITY|Linear mixed effects|Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.54||0.49|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that cigarettes smoked would be higher for those in the Tobacco retailer group, relative to the Nontobacco retailer group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.49
71700842|NCT04279483|142917218|SUPERIORITY|Linear mixed effects|Slope|0.21|STANDARD_ERROR_OF_MEAN|0.59||0.72|TWO_SIDED|||||Statistical significance was evaluated at α = 0.05.|Mixed Models Analysis|||Our hypothesis was that craving would be higher for those in the Tobacco retailer group, relative to the control group, during the intervention phase but not the baseline phase. We tested the interaction between study phase and experimental condition, in a model where the baseline was the reference study phase and Tobacco group was the reference experimental condition.||||0.72
71700843|NCT00879658|142917246|SUPERIORITY||Negative binomial regression model|0.524||||0.148|TWO_SIDED|95.0|0.219|1.257||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||An ARR-ratio \<1 favors active treatment.|1.257|0.219|0.148
71700844|NCT00879658|142917246|SUPERIORITY||Negative binomial regression model|0.34||||0.041|TWO_SIDED|95.0|0.121|0.956||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||0.956|0.121|0.041
71738830|NCT05274269|142990510|SUPERIORITY||LS Mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.6|1.9|||Mixed Models for Repeated Measures|||||1.9|0.6|< 0.0001
71700845|NCT00879658|142917246|SUPERIORITY||Negative binomial regression model|1.051||||0.899|TWO_SIDED|95.0|0.486|2.273||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \<1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.||||2.273|0.486|0.899
71700846|NCT00879658|142917247|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.915||||0.879|TWO_SIDED|95.0|0.288|2.925|||Regression, Logistic|"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."||||2.925|0.288|0.879
71700847|NCT00879658|142917247|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.745||||0.399|TWO_SIDED|95.0|0.484|7.167||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||7.167|0.484|0.399
71700848|NCT00879658|142917247|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.697||||0.454|TWO_SIDED|95.0|0.438|8.296||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||8.296|0.438|0.454
71700849|NCT00879658|142917247|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.509||||0.223|TWO_SIDED|95.0|0.166|1.511||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||1.511|0.166|0.223
71700850|NCT00879658|142917247|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.785||||0.668|TWO_SIDED|95.0|0.253|2.392||"Proportions are estimated from the logistic regression model.~\- An odds ratio of \> 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic|||||2.392|0.253|0.668
71700851|NCT00879658|142917248|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.996||||0.178|TWO_SIDED|95.0|0.731|5.669|||Regression, Logistic|Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.||||5.669|0.731|0.178
71700852|NCT00879658|142917248|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|4.12||||0.014|TWO_SIDED|95.0|1.328|14.681||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||14.681|1.328|0.014
71700853|NCT00879658|142917248|OTHER|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.266||||0.642|TWO_SIDED|95.0|0.468|3.494||Proportions are estimated from the logistic regression model. - An odds ratio of \> 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic|||||3.494|0.468|0.642
71700854|NCT00879658|142917249|SUPERIORITY||lesion ratio|0.138|||<|0.001|TWO_SIDED|95.0|0.047|0.408|||Regression, Logistic|new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.408|0.047|<0.001
71700855|NCT00879658|142917249|SUPERIORITY||lesion ratio|0.307||||0.012|TWO_SIDED|95.0|0.123|0.771||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.771|0.123|0.012
71700856|NCT00879658|142917249|SUPERIORITY||lesion ratio|0.113|||<|0.001|TWO_SIDED|95.0|0.036|0.358||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.358|0.036|<0.001
71700857|NCT00879658|142917249|SUPERIORITY||lesion ratio|0.375||||0.021|TWO_SIDED|95.0|0.163|0.86||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.860|0.163|0.021
71700858|NCT00879658|142917249|SUPERIORITY||lesion ratio|0.478||||0.062|TWO_SIDED|95.0|0.22|1.037||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.037|0.220|0.062
71700859|NCT00879658|142917250|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|Lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.063|0.376|||Regression, Logistic|new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||||0.376|0.063|<0.001
71700860|NCT00879658|142917250|SUPERIORITY||lesion ratio|0.228||||0.005|TWO_SIDED|95.0|0.081|0.641||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.641|0.081|0.005
71700861|NCT00879658|142917250|SUPERIORITY||lesion ratio|0.188|||<|0.001|TWO_SIDED|95.0|0.07|0.509||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.509|0.070|<0.001
71700862|NCT00879658|142917251|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.279||||0.002|TWO_SIDED|95.0|0.124|0.628||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.628|0.124|0.002
71700863|NCT00879658|142917251|SUPERIORITY||lesion ratio|0.396||||0.019|TWO_SIDED|95.0|0.182|0.861||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.861|0.182|0.019
71700864|NCT00879658|142917251|SUPERIORITY||lesion ratio|0.154|||<|0.001|TWO_SIDED|95.0|0.059|0.4||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.400|0.059|<0.001
71700865|NCT00879658|142917251|SUPERIORITY||lesion ratio|0.454||||0.035|TWO_SIDED|95.0|0.219|0.945||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.945|0.219|0.035
71700866|NCT00879658|142917251|SUPERIORITY||lesion ratio|0.555||||0.087|TWO_SIDED|96.0|0.283|1.09||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.090|0.283|0.087
71700867|NCT00879658|142917252|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.095|||<|0.001|TWO_SIDED|95.0|0.033|0.273||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.273|0.033|<0.001
71700868|NCT00879658|142917252|SUPERIORITY||lesion ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.069|0.47||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.470|0.069|<0.001
71700869|NCT00879658|142917252|SUPERIORITY||lesion ratio|0.173|||<|0.001|TWO_SIDED|95.0|0.069|0.434||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.434|0.069|<0.001
71700870|NCT00879658|142917253|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.259||||0.005|TWO_SIDED|95.0|0.1|0.67||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.670|0.100|0.005
71700871|NCT00879658|142917253|SUPERIORITY||lesion ratio|0.276||||0.005|TWO_SIDED|95.0|0.112|0.676||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.676|0.112|0.005
71700872|NCT00879658|142917253|SUPERIORITY||lesion ratio|0.118|||<|0.001|TWO_SIDED|95.0|0.034|0.409||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.409|0.034|<0.001
71700873|NCT00879658|142917253|SUPERIORITY||lesion ratio|0.683||||0.485|TWO_SIDED|95.0|0.234|1.991||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.991|0.234|0.485
71700874|NCT00879658|142917253|SUPERIORITY||lesion ratio|0.591||||0.142|TWO_SIDED|95.0|0.292|1.193||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.193|0.292|0.142
71700875|NCT00879658|142917254|SUPERIORITY|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.161|||<|0.001|TWO_SIDED|95.0|0.062|0.421||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||||0.421|0.062|<0.001
71890439|NCT00348140|143302379|SUPERIORITY||Mean Difference (Net)|-2.4||||0.043|TWO_SIDED|95.0|-4.7|-0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||-0.1|-4.7|0.043
71700876|NCT00879658|142917254|SUPERIORITY||lesion ratio|0.197||||0.001|TWO_SIDED|95.0|0.074|0.527||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||0.527|0.074|0.001
71700877|NCT00879658|142917254|SUPERIORITY||lesion ratio|0.416||||0.139|TWO_SIDED|95.0|0.13|1.331||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.||1.331|0.130|0.139
71700878|NCT00879658|142917255|SUPERIORITY|||||||0.227||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.227
71700879|NCT00879658|142917255|SUPERIORITY|||||||0.02||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.020
71700880|NCT00879658|142917255|SUPERIORITY|||||||0.001||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.001
71700881|NCT00879658|142917255|SUPERIORITY|||||||0.122||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.122
71700882|NCT00879658|142917255|SUPERIORITY|||||||0.034||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.034
71700883|NCT00879658|142917256|SUPERIORITY|||||||0.335||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.335
71700884|NCT00879658|142917256|SUPERIORITY|||||||0.022||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.022
71700885|NCT00879658|142917256|SUPERIORITY|||||||0.124||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic|||||||0.124
71700886|NCT00879658|142917257|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.129||||0.006|TWO_SIDED|95.0|0.03|0.561||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.561|0.030|0.006
71700887|NCT00879658|142917257|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.159||||0.005|TWO_SIDED|95.0|0.044|0.578||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.578|0.044|0.005
71700888|NCT00879658|142917257|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.052||||0.005|TWO_SIDED|95.0|0.007|0.405||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.405|0.007|0.005
71700889|NCT00879658|142917257|SUPERIORITY||lesion ratio|0.271||||0.019|TWO_SIDED|95.0|0.091|0.807||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.||0.807|0.091|0.019
71700890|NCT00879658|142917257|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.504||||0.169|TWO_SIDED|95.0|0.19|1.337||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||1.337|0.190|0.169
71700891|NCT00879658|142917258|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.214|||<|0.001|TWO_SIDED|95.0|0.091|0.499||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.499|0.091|<0.001
71700892|NCT00879658|142917258|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.24||||0.018|TWO_SIDED|95.0|0.074|0.779||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.779|0.074|0.018
71700893|NCT00879658|142917258|SUPERIORITY|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.231||||0.006|TWO_SIDED|95.0|0.081|0.653||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||||0.653|0.081|0.006
71700894|NCT04530344|142917305|SUPERIORITY||Hazard Ratio (HR)|0.422||||0.0414|TWO_SIDED|95.0|0.18|0.99|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.990|0.180|0.0414
71700895|NCT04530344|142917306|SUPERIORITY||Hazard Ratio (HR)|0.316||||0.0003|TWO_SIDED|95.0|0.165|0.606|||Log Rank|The p-value was based on the log-rank test stratified by randomization stratification factor between treatment and vehicle.||Cox regression model stratified by stratification factor (treatment assignment in the parent studies) was conducted to compare the difference in hazard rate between treatment and vehicle.||0.606|0.165|0.0003
71700896|NCT05523297|142917369|NON_INFERIORITY|The test for non-inferiority was one-sided Farrington-Manning score test with non-inferiority margin 10% at a significance level of 2.5%. If the 95% CI for treatment effect not only lay above -10% (the non-inferiority margin) but also above 0, then there was evidence of superiority.|percent difference|17.55|||<|0.0001|TWO_SIDED|95.0|8.7|26.4|||Two-sided Farrington-Manning score test.||Difference between Octaplex and FP arms for effectiveness|||26.4|8.7|<0.0001
71700897|NCT05523297|142917370|OTHER||Odds Ratio (OR)|1.91||||0.0022|TWO_SIDED|95.0|1.26|2.88|||Regression, Logistic|||||2.88|1.26|0.0022
71700898|NCT05523297|142917371|OTHER||Least Squares Mean Difference|-170.73|||<|0.0001|TWO_SIDED|95.0|-250.24|-91.22|||ANOVA|||12 hours after chest closure||-91.22|-250.24|<0.0001
71700899|NCT05523297|142917371|OTHER||Least Squares Mean Difference|-231.92|||<|0.0001|TWO_SIDED|95.0|-338.17|-125.67|||ANOVA|||24 hours after chest closure||-125.67|-338.17|<0.0001
71700900|NCT05523297|142917372|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after IMP start||5.15|1.97|<0.0001
71822709|NCT03582137|143148212|SUPERIORITY||Mean Difference (Net)|0.9536||||0.7557|TWO_SIDED|95.0|-5.1655|7.0727|||Mixed Models Analysis|||||7.0727|-5.1655|0.7557
71822710|NCT03582137|143148214|SUPERIORITY||Mean Difference (Net)|0.05126||||0.915|TWO_SIDED|95.0|-0.9086|1.0111|||Mixed Models Analysis|||||1.0111|-0.9086|0.9150
71822711|NCT03582137|143148215|SUPERIORITY||Mean Difference (Net)|-0.6699||||0.6164|TWO_SIDED|95.0|-3.3316|1.9918|||Mixed Models Analysis|||||1.9918|-3.3316|0.6164
71822712|NCT03582137|143148216|SUPERIORITY||Mean Difference (Net)|-0.1358||||0.755|TWO_SIDED|95.0|-1.0028|0.7312|||Mixed Models Analysis|||||0.7312|-1.0028|0.7550
71822713|NCT03582137|143148217|SUPERIORITY||Mean Difference (Net)|-0.09605||||0.9016|TWO_SIDED|95.0|-1.6449|1.4528|||Mixed Models Analysis|||||1.4528|-1.6449|0.9016
71822714|NCT03582137|143148218|SUPERIORITY||Mean Difference (Net)|-0.3217||||0.9219|TWO_SIDED|95.0|-6.8584|6.2151|||Mixed Models Analysis|||||6.2151|-6.8584|0.9219
71822715|NCT03582137|143148219|SUPERIORITY||Mean Difference (Net)|0.02897||||0.3178|TWO_SIDED|95.0|-0.02857|0.08651|||Mixed Models Analysis|||||0.08651|-0.02857|0.3178
71700901|NCT05523297|142917372|OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.83|4.52|||Regression, Logistic|||Within 24 hours after surgery start||4.52|1.83|<0.0001
71822716|NCT03582137|143148224|SUPERIORITY||Mean Difference (Net)|0.2288||||0.7693|TWO_SIDED|95.0|-1.325|1.7825|||Mixed Models Analysis|||||1.7825|-1.3250|0.7693
71822717|NCT03582137|143148225|SUPERIORITY||Mean Difference (Net)|-0.8121||||0.5285|TWO_SIDED|95.0|-3.3743|1.7501|||Mixed Models Analysis|||||1.7501|-3.3743|0.5285
71822718|NCT03582137|143148226|SUPERIORITY||Mean Difference (Net)|-0.02525||||0.9463|TWO_SIDED|95.0|-0.7717|0.7212|||Mixed Models Analysis|||||0.7212|-0.7717|0.9463
71822719|NCT03582137|143148227|SUPERIORITY||Mean Difference (Net)|-0.3042||||0.4362|TWO_SIDED|95.0|-1.0817|0.4732|||Mixed Models Analysis|||||0.4732|-1.0817|0.4362
71822720|NCT03582137|143148228|SUPERIORITY||Mean Difference (Net)|-0.06489||||0.9327|TWO_SIDED|95.0|-1.5957|1.4659|||Mixed Models Analysis|||||1.4659|-1.5957|0.9327
71822721|NCT03582137|143148231|SUPERIORITY||Mean Difference (Net)|-0.2763||||0.4401|TWO_SIDED|95.0|-0.988|0.4354|||Mixed Models Analysis|||||0.4354|-0.9880|0.4401
71822722|NCT03582137|143148232|SUPERIORITY||Mean Difference (Net)|-0.8319||||0.8085|TWO_SIDED|95.0|-7.6835|6.0197|||Mixed Models Analysis|||||6.0197|-7.6835|0.8085
71822723|NCT03582137|143148234|SUPERIORITY||Mean Difference (Net)|0.02673||||0.9674|TWO_SIDED|95.0|-1.2757|1.3292|||Mixed Models Analysis|||||1.3292|-1.2757|0.9674
71822724|NCT03582137|143148236|SUPERIORITY||Mean Difference (Net)|-46.92||||0.1128|TWO_SIDED|95.0|-105.51|11.68|||Mixed Models Analysis|||||11.68|-105.51|0.1128
71822725|NCT02303574|143148250|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.287|STANDARD_ERROR_OF_MEAN|0.05085|||TWO_SIDED|95.0|1.183|1.391||||||||1.391|1.183|
71822726|NCT02303574|143148250|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|90.72|||||TWO_SIDED|90.0|83.72|98.31||||||||98.31|83.72|
71822727|NCT02303574|143148251|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
71822728|NCT02303574|143148251|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
71822729|NCT02303574|143148251|OTHER|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
71822730|NCT02303574|143148252|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.228|STANDARD_ERROR_OF_MEAN|0.1329|||TWO_SIDED|95.0|0.9513|1.504||||||||1.504|0.9513|
71822731|NCT02303574|143148252|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||TWO_SIDED|90.0|140.61|180.7||||||||180.70|140.61|
71822732|NCT02303574|143148252|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||TWO_SIDED|90.0|138.23|166.74||||||||166.74|138.23|
71700902|NCT05523297|142917372|OTHER||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.97|5.15|||Regression, Logistic|||Within 24 hours after CPB end||5.15|1.97|<0.0001
71700903|NCT05523297|142917373|OTHER||Mean ratio|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Counting regression|||||0.57|0.41|<0.0001
71700904|NCT05523297|142917374|OTHER||Mean ratio|0.71||||0.0015|TWO_SIDED|95.0|0.57|0.88|||Counting regression|||||0.88|0.57|0.0015
71700905|NCT05523297|142917375|OTHER||Mean ratio|0.61||||0.001|TWO_SIDED|95.0|0.46|0.82|||Counting regression|||During the first 24 hours after IMP start||0.82|0.46|0.0010
71700906|NCT05523297|142917375|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Counting regression|||During the first 7 days after IMP start||0.76|0.45|<0.0001
71700907|NCT05523297|142917376|OTHER||Mean ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06|||Negative binomial regression|||FP including IMP (During the first 24 hours after IMP start)||0.06|0.03|<0.0001
71700908|NCT05523297|142917376|OTHER||Mean ratio|0.85||||0.8522|TWO_SIDED|95.0|0.15|4.82|||Negative binomial regression|||FP excluding IMP (During the first 24 hours after IMP start)||4.82|0.15|0.8522
71700909|NCT05523297|142917376|OTHER||Mean ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Negative binomial regression|||RBCs (During the first 24 hours after IMP start)||0.68|0.40|<0.0001
71700910|NCT05523297|142917376|OTHER||Mean ratio|0.65||||0.0169|TWO_SIDED|95.0|0.45|0.92|||Negative binomial regression|||Platelets (During the first 24 hours after IMP start)||0.92|0.45|0.0169
71700911|NCT05523297|142917376|OTHER||Mean ratio|0.57||||0.3288|TWO_SIDED|95.0|0.18|1.76|||Negative binomial regression|||Cryoprecipitate (During the first 24 hours after IMP start)||1.76|0.18|0.3288
71700912|NCT05523297|142917376|OTHER||Mean ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.04|0.06|||Negative binomial regression|||FP including IMP (During the first 7 days after IMP start)||0.06|0.04|<0.0001
71700913|NCT05523297|142917376|OTHER||Mean ratio|0.63||||0.5439|TWO_SIDED|95.0|0.14|2.84|||Negative binomial regression|||FP excluding IMP (During the first 7 days after IMP start)||2.84|0.14|0.5439
71700914|NCT05523297|142917376|OTHER||Mean ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.74|||Negative binomial regression|||Red blood cells (During the first 7 days after IMP start)||0.74|0.47|<0.0001
71700915|NCT05523297|142917376|OTHER||Mean ratio|0.58||||0.0042|TWO_SIDED|95.0|0.4|0.84|||Negative binomial regression|||Platelets (During the first 7 days after IMP start)||0.84|0.40|0.0042
71700916|NCT05523297|142917376|OTHER||Mean ratio|0.49||||0.2241|TWO_SIDED|95.0|0.15|1.56|||Negative binomial regression|||Cryoprecipitate (During the first 7 days after IMP start)||1.56|0.15|0.2241
71700917|NCT05523297|142917377|OTHER||Odds Ratio (OR)|0.9||||0.8364|TWO_SIDED|95.0|0.32|2.52|||Regression, Logistic|||FP excluding IMP (Within 24 hours after IMP start)||2.52|0.32|0.8364
71700918|NCT05523297|142917377|OTHER||Odds Ratio (OR)|2.11||||0.0002|TWO_SIDED|95.0|1.42|3.11|||Regression, Logistic|||RBCs (Within 24 hours after IMP start)||3.11|1.42|0.0002
71700919|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.31||||0.1742|TWO_SIDED|95.0|0.89|1.91|||Regression, Logistic|||Platelets (Within 24 hours after IMP start)||1.91|0.89|0.1742
71700920|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 24 hours after IMP start)||3.38|0.58|0.4618
71700921|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.69||||0.0129|TWO_SIDED|95.0|1.12|2.55|||Regression, Logistic|||Any individual ABP (Within 24 hours after IMP start)||2.55|1.12|0.0129
71700922|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.58||||0.3297|TWO_SIDED|95.0|0.63|3.94|||Regression, Logistic|||FP excluding IMP (Within 7 days after IMP start)||3.94|0.63|0.3297
71700923|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.82||||0.0049|TWO_SIDED|95.0|1.2|2.76|||Regression, Logistic|||RBCs (Within 7 days after IMP start)||2.76|1.20|0.0049
71700924|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.26||||0.2417|TWO_SIDED|95.0|0.86|1.84|||Regression, Logistic|||Platelets (Within 7 days after IMP start)||1.84|0.86|0.2417
71700925|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.4||||0.4618|TWO_SIDED|95.0|0.58|3.38|||Regression, Logistic|||Cryoprecipitate (Within 7 days after IMP start)||3.38|0.58|0.4618
71700926|NCT05523297|142917377|OTHER||Odds Ratio (OR)|1.56||||0.0564|TWO_SIDED|95.0|0.99|2.47|||Regression, Logistic|||Any individual ABP (Within 7 days after IMP start)||2.47|0.99|0.0564
71700927|NCT05523297|142917378|OTHER||Odds Ratio (OR)|1.1||||0.6956|TWO_SIDED|95.0|0.69|1.73|||Regression, Logistic|||Fibrinogen concentrate (Within 24 hours after IMP start)||1.73|0.69|0.6956
71700928|NCT05523297|142917378|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||||50.70|1.12|0.0317
71700929|NCT05523297|142917378|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 24 hours after IMP start)||796.37|2.90|<0.0001
71700930|NCT05523297|142917378|OTHER||Odds Ratio (OR)|1.334||||0.1981|TWO_SIDED|95.0|0.86|2.07|||Regression, Logistic|||Any coagulation factor product (Within 24 hours after IMP start)||2.07|0.86|0.1981
71700931|NCT05523297|142917378|OTHER||Odds Ratio (OR)|1.187||||0.4599|TWO_SIDED|95.0|0.75|1.87|||Regression, Logistic|||Fibrinogen concentrate (Within 7 days after IMP start)||1.87|0.75|0.4599
71700932|NCT05523297|142917378|OTHER||Odds Ratio (OR)|5.337||||0.0317|TWO_SIDED|95.0|1.12|50.7|||Regression, Logistic|||rFVIIa (Within 7 days after IMP start)||50.70|1.12|0.0317
71700933|NCT05523297|142917378|OTHER||Odds Ratio (OR)|18.88|||<|0.0001|TWO_SIDED|95.0|2.9|796.37|||Regression, Logistic|||PCC excluding IMP (Within 7 days after IMP start)||796.37|2.90|<0.0001
71700934|NCT05523297|142917378|OTHER||Odds Ratio (OR)|1.431||||0.1073|TWO_SIDED|95.0|0.93|2.21|||Regression, Logistic|||Any coagulation factor product (Within 7 days after IMP start)||2.21|0.93|0.1073
71700935|NCT05523297|142917381|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after CPB end||3.2013|0.6429|0.3782
71700936|NCT05523297|142917381|OTHER||Odds Ratio (OR)|1.435||||0.3782|TWO_SIDED|95.0|0.6429|3.2013|||Regression, Logistic|||Within 24 hours after IMP start||3.2013|0.6429|0.3782
71700937|NCT05523297|142917381|OTHER||Odds Ratio (OR)|1.332||||0.4899|TWO_SIDED|95.0|0.5902|3.0062|||Regression, Logistic|||Within 24 hours after surgery start||3.0062|0.5902|0.4899
71700938|NCT05523297|142917382|OTHER||Least Squares Mean Difference|-0.15||||0.0081|TWO_SIDED|95.0|-0.26|-0.04|||ANOVA|||||-0.04|-0.26|0.0081
71700939|NCT05523297|142917383|OTHER||Least Squares Mean Difference|-9.63||||0.6735|TWO_SIDED|95.0|-60.45|41.18|||ANOVA|||||41.18|-60.45|0.6735
71700940|NCT05523297|142917384|OTHER||Least Squares Mean Difference|-17.93||||0.9033|TWO_SIDED|95.0|-450.13|414.28|||ANOVA|||||414.28|-450.13|0.9033
71700941|NCT05523297|142917385|OTHER||Least Squares Mean Difference|-0.41||||0.1808|TWO_SIDED|95.0|-1.1|0.29|||ANOVA|||||0.29|-1.10|0.1808
71700942|NCT05523297|142917386|OTHER||Least Squares Mean Difference|0.28||||0.9698|TWO_SIDED|95.0|-14.78|15.34|||ANOVA|||||15.34|-14.78|0.9698
71700943|NCT05523297|142917387|OTHER||Least Squares Mean Difference|-3.1||||0.3363|TWO_SIDED|95.0|-9.61|3.42|||ANOVA|||||3.42|-9.61|0.3363
71700944|NCT05523297|142917388|OTHER||Least Squares Mean Difference|2.42||||0.5736|TWO_SIDED|95.0|-6.33|11.16|||ANOVA|||||11.16|-6.33|0.5736
71700945|NCT05523297|142917389|OTHER||Least Squares Mean Difference|-13.19||||0.2667|TWO_SIDED|95.0|-37.05|10.67|||ANOVA|||||10.67|-37.05|0.2667
71700946|NCT05523297|142917390|OTHER||Least Squares Mean Difference|12.25||||0.0658|TWO_SIDED|95.0|-0.87|25.38|||ANOVA|||||25.38|-0.87|0.0658
71700947|NCT05523297|142917391|OTHER||Least Squares Mean Difference|-0.19||||0.0726|TWO_SIDED|95.0|-0.4|0.02|||ANOVA|||||0.02|-0.40|0.0726
71700948|NCT05523297|142917396|OTHER||Odds Ratio (OR)|1.183||||0.7497|TWO_SIDED|95.0|0.4211|3.3235|||Regression, Logistic|||||3.3235|0.4211|0.7497
71700949|NCT04133909|142917453|SUPERIORITY||Rate ratio (Mepolizumab 100 mg/Placebo)|0.79||||0.011|TWO_SIDED|95.0|0.66|0.94|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (less than or equal to \[\<=\]2, 3, \>=4 as ordinal), baseline percent (%) predicted Forced expiratory volume in one second (FEV1) and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable.||0.94|0.66|0.011
71700950|NCT04133909|142917454|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.64|0.93|||Cox Proportional Hazards Model|||Estimated from a Cox Proportional Hazards Model with covariates of treatment group, geographic region, number of moderate or severe exacerbations in previous year \<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs former).||0.93|0.64|0.009
71700951|NCT04133909|142917455|SUPERIORITY||Odds Ratio (OR)|0.81||||0.161|TWO_SIDED|95.0|0.6|1.09|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.09|0.60|0.161
71700952|NCT04133909|142917456|SUPERIORITY||Odds Ratio (OR)|1.17||||0.291|TWO_SIDED|95.0|0.87|1.57|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.57|0.87|0.291
71822733|NCT02303574|143148252|OTHER|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||TWO_SIDED|90.0|146.67|171.67||||||||171.67|146.67|
71890440|NCT00348140|143302379|SUPERIORITY||Mean Difference (Net)|-2.2||||0.056|TWO_SIDED|95.0|-4.5|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12||0.1|-4.5|0.056
71700953|NCT04133909|142917457|SUPERIORITY||Odds Ratio (OR)|0.82||||0.209|TWO_SIDED|95.0|0.6|1.12|||Regression, Logistic|||A logistic regression model was used to compare the proportion of responders between the mepolizumab and placebo arms in the mITT and mITT2 populations. The model includes fixed categorical covariates (treatment group, smoking status, geographic region) and a fixed continuous covariate (baseline score).||1.12|0.60|0.209
71700954|NCT04133909|142917458|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.65||||0.032|TWO_SIDED|95.0|0.43|0.96|||Negative binomial model|||Analysis performed using a negative binomial model with covariates of treatment group, geographic region, number of moderate/severe exacerbations in previous year (\<=2, 3, \>=4 as ordinal), baseline % predicted FEV1 and smoking status (current vs. former smoker), and with logarithm (time on- and off-treatment) as an offset variable. Estimates based on weighting applied to each level of class variable determined from observed proportions.||0.96|0.43|0.032
71700955|NCT01299909|142917460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.35|TWO_SIDED|95.0|0.67|3.51|||Regression, Logistic|||||3.51|0.67|0.35
71700956|NCT01299909|142917461|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
71822734|NCT02303574|143148253|OTHER||Slope|1.302|STANDARD_ERROR_OF_MEAN|0.05056|||TWO_SIDED|95.0|1.198|1.406||||||Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.||1.406|1.198|
71700957|NCT01299909|142917462|SUPERIORITY||Mean Difference (Final Values)|6.09||||0.02|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.02
71700958|NCT01299909|142917463|SUPERIORITY||Mean Difference (Final Values)|4.96||||0.03|TWO_SIDED||||||ANOVA|df=(1,57)||||||0.03
71700959|NCT05399485|142917487|SUPERIORITY||[Difference in Least square (LS) Mean]|-1.1||||0.0021|TWO_SIDED|95.0|-1.73|-0.38|||Mixed Models Analysis|||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as a covariate, treatment group, randomization stratum (stable prophylactic migraine medication use throughout randomization), month, and month-by treatment group interaction as fixed effects.||-0.38|-1.73|0.0021
71700960|NCT05399485|142917488|SUPERIORITY||Difference in Percentage|7.3||||0.0989|TWO_SIDED|95.0|-1.4|15.9||P-value \>0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel|||The percentages of participants with reductions were compared between treatment groups using Mantel-Haenszel risk estimation with stratification by randomization stratum (stable prophylactic migraine medication use throughout randomization; yes, no).||15.9|-1.4|0.0989
71822735|NCT02303574|143148253|OTHER|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|64.14|||||TWO_SIDED|90.0|55.07|74.7||||||||74.70|55.07|
71822736|NCT02303574|143148254|OTHER|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.157|STANDARD_ERROR_OF_MEAN|0.1098|||TWO_SIDED|95.0|0.9285|1.385||||||||1.385|0.9285|
71700961|NCT06023563|142917513|OTHER|The required sample size for medium effect size (f = 0.25) and power of 0.80 was calculated to be 6 participants in each group (n =12) (G\*power 3.1.9.7 software). Data were analyzed using IBM SPSS statistical package (version 29.0.1.0).|||||<|0.05|||||||Friedman's test|||A virtual reality active video gaming intervention will be more effective than traditional physical therapy based balance exercises, both based on motor learning principles, in improving static and dynamic balance in youth and young adults with ASD and these improvements will be retained at 4 weeks after the intervention.||||< 0.05
71700962|NCT06023563|142917514|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700963|NCT06023563|142917515|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700964|NCT06023563|142917516|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700965|NCT06023563|142917517|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700966|NCT06023563|142917518|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700967|NCT06023563|142917519|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700968|NCT06023563|142917520|OTHER||||||<|0.05|||||||Friedman's test|||||||< 0.05
71700969|NCT03474107|142917521|SUPERIORITY||Stratified Hazard Ratio|0.702||||0.00142|TWO_SIDED|95.0|0.556|0.886||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P-value of overall survival is ≤ the predetermined 1-sided significance level of 0.00679 based on the number of observed deaths.|Stratified Log rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.886|0.556|0.00142
71700970|NCT03474107|142917522|SUPERIORITY||Stratified Hazard Ratio|0.615|||<|1e-05|TWO_SIDED|95.0|0.505|0.748||Stratification factors were ECOG PS, geographic region and liver metastasis. P-value was based on log-rank test. P value of PFS is ≤ the predetermined 1-sided significance level of 0.02189 based on the number of observed PFS events.|Stratified Log Rank||Cox proportional hazards model with treatment, ECOG PS, geographic region and liver metastasis as the explanatory variables.|||0.748|0.505|<0.00001
71700971|NCT03474107|142917523|SUPERIORITY||||||<|0.001||||||"Stratification factors were ECOG PS, Region and Liver Metastasis."|Stratified Cochran-Mantel-Haenszel|||||||<0.001
71700972|NCT03474107|142917524|SUPERIORITY||||||<|0.001||||||Stratification factors were ECOG PS, Region and Liver Metastasis.|Stratified Cochran-Mantel-Haenszel|||||||<0.001
71700973|NCT00055237|142917535|SUPERIORITY_OR_OTHER||proportion estimate,binomial exact 95%CI|31.0|STANDARD_DEVIATION|11.6|||TWO_SIDED|95.0|11.0|58.7|||sample estimate with 95% CI||As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.|||58.7|11|
71700974|NCT02127671|142917537|SUPERIORITY||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-22.9|-2.5||||||||-2.5|-22.9|
71700975|NCT02127671|142917539|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.9||||||||0.9|-0.7|
71700976|NCT02127671|142917543|SUPERIORITY||Mean Difference (Net)|-7.6|||||TWO_SIDED|95.0|-17.6|2.4||||||||2.4|-17.6|
71700977|NCT02127671|142917544|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||||0.2|-0.3|
71700978|NCT02127671|142917545|SUPERIORITY||Mean Difference (Net)|-10.5|||||TWO_SIDED|95.0|-18.4|-2.6||||||||-2.6|-18.4|
71700979|NCT02127671|142917546|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-5.1|1.5||||||systolic||1.5|-5.1|
71700980|NCT02127671|142917546|SUPERIORITY||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.8|0.5||||||diastolic||0.5|-3.8|
71700981|NCT02127671|142917548|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-13.3|4.7||||||||4.7|-13.3|
71700982|NCT02127671|142917549|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-12.7|2.0||||||||2.0|-12.7|
71700983|NCT02127671|142917550|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.8|3.8||||||||3.8|-1.8|
71700984|NCT02127671|142917551|SUPERIORITY||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-13.4|29.6||||||||29.6|-13.4|
71700985|NCT03834168|142917559|OTHER|||||||0.003|||||||Regression (Cosinor Fit)|||||||0.003
71700986|NCT03834168|142917559|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<0.001
71700987|NCT03556683|142917562|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Effect immediately following hypertonic saline treatment.||||<0.001
71700988|NCT03556683|142917563|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||Effect of hypertonic saline 4 hours after treatment.||||0.99
71700989|NCT00764517|142917568|OTHER||Hazard Ratio (HR)|0.33||||0.002|TWO_SIDED|95.0|0.16|0.69|||Log Rank|||||0.69|0.16|0.002
71700990|NCT00764517|142917569|OTHER||Hazard Ratio (HR)|0.42||||0.011|TWO_SIDED|95.0|0.21|0.84|||Log Rank|||||0.84|0.21|0.011
71700991|NCT00621530|142917587|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.||||=0.94
71700992|NCT00621530|142917588|SUPERIORITY||||||=|0.78|||||||ANOVA|Repeated measures ANOVA||||||=0.78
71700993|NCT00621530|142917589|SUPERIORITY||||||=|0.87|||||||ANOVA|Repeated measures ANOVA||||||=0.87
71700994|NCT00621530|142917590|SUPERIORITY||||||=|0.66|||||||ANOVA|Repeated measures ANOVA||||||=0.66
71700995|NCT00621530|142917591|SUPERIORITY||||||=|0.83|||||||ANOVA|Repeated measures ANOVA||||||=0.83
71700996|NCT00671060|142917599|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.682|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Rates of success were compared across study arms. The study was a separate, non-comparative efficacy study. In order to have 80% power (alpha=.05) to demonstrate that each misoprostol regimen was 95%, ± 5%, effective, we enrolled 73 women in each arm of the study, or 146 women total. The sample size also provided 80% power (alpha=.05) to detect a significant difference between treatments should 200μg prove 98% effective and 100μg prove 88% effective.||||<0.05
71700997|NCT02107898|142917608|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.1|||<|0.0001|TWO_SIDED|95.0|-68.5|-59.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.8|-68.5|<0.0001
71700998|NCT02107898|142917609|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.3|||<|0.0001|TWO_SIDED|95.0|-69.4|-61.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.3|-69.4|<0.0001
71700999|NCT02107898|142917610|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.5|||<|0.0001|TWO_SIDED|95.0|-65.3|-57.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.7|-65.3|<0.0001
71701000|NCT02107898|142917611|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.1|||<|0.0001|TWO_SIDED|95.0|-65.8|-58.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.3|-65.8|<0.0001
71701001|NCT02107898|142917612|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.3|||<|0.0001|TWO_SIDED|95.0|-57.5|-49.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.1|-57.5|<0.0001
71701002|NCT02107898|142917613|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|||<|0.0001|TWO_SIDED|95.0|-57.8|-49.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-57.8|<0.0001
71701003|NCT02107898|142917614|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.5|||<|0.0001|TWO_SIDED|95.0|-61.5|-53.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.5|-61.5|<0.0001
71701004|NCT02107898|142917615|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-62.3|-54.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.8|-62.3|<0.0001
71701005|NCT02107898|142917616|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.5|||<|0.0001|TWO_SIDED|95.0|-44.6|-38.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.4|-44.6|<0.0001
71701006|NCT02107898|142917617|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-54.9|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-54.9|<0.0001
71701007|NCT02107898|142917618|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.5|||<|0.0001|TWO_SIDED|95.0|-57.9|-51.1|||Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.1|-57.9|<0.0001
71701008|NCT02107898|142917619|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-41.7|-36.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.4|-41.7|<0.0001
71701009|NCT02107898|142917620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|552.1|||<|0.0001|TWO_SIDED|95.0|105.6|2886.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2886.8|105.6|<0.0001
71701010|NCT02107898|142917621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1367.8|||<|0.0001|TWO_SIDED|95.0|137.8|13578.3||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13578.3|137.8|<0.0001
71701011|NCT02107898|142917622|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-36.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.0|-48.0|<0.0001
71701012|NCT02107898|142917623|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-30.9|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.1|-30.9|<0.0001
71701013|NCT02107898|142917624|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.002|TWO_SIDED|95.0|2.1|9.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.4|2.1|0.0020
71701014|NCT02107898|142917625|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.0382|TWO_SIDED|95.0|0.2|7.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|0.2|0.0382
71822737|NCT00783718|143148306|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.7|||<|0.0001|TWO_SIDED|95.0|11.6|31.7|||Cochran-Mantel-Haenszel|||The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator \[6-mercaptopurine or azathioprine\] use).||31.7|11.6|< 0.0001
71884462|NCT02171611|143288879|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|175.4|STANDARD_ERROR_OF_MEAN|51.1|||TWO_SIDED|90.0|141.924|216.772|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||216.772|141.924|
71822738|NCT00783718|143148307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.0001|TWO_SIDED|95.0|14.9|37.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||37.2|14.9|< 0.0001
71822739|NCT00783718|143148307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.1|||<|0.0001|TWO_SIDED|95.0|17.9|40.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||40.4|17.9|< 0.0001
71822740|NCT00783718|143148308|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.5||||0.0009|TWO_SIDED|95.0|4.7|18.3||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||18.3|4.7|0.0009
71822741|NCT00783718|143148309|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.1||||0.0012||95.0|6.4|25.9||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.||25.9|6.4|0.0012
71822742|NCT00783718|143148310|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.8|||<|0.0001|TWO_SIDED|95.0|20.8|44.7||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||44.7|20.8|< 0.0001
71822743|NCT00783718|143148310|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.5|||<|0.0001|TWO_SIDED|95.0|16.7|40.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||40.3|16.7|< 0.0001
71822744|NCT00783718|143148311|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.0|||<|0.0001|TWO_SIDED|95.0|20.3|43.8||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||43.8|20.3|< 0.0001
71822745|NCT00783718|143148311|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.3|||<|0.0001|TWO_SIDED|95.0|24.4|48.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||48.3|24.4|< 0.0001
71884463|NCT02171611|143288879|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|158.12|STANDARD_ERROR_OF_MEAN|46.7|||TWO_SIDED|90.0|130.052|192.255|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||192.255|130.052|
71822746|NCT00783718|143148312|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.8||||0.0079|TWO_SIDED|95.0|3.1|20.5||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||20.5|3.1|0.0079
71822747|NCT00783718|143148312|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0009|TWO_SIDED|95.0|6.2|24.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||24.4|6.2|0.0009
71822748|NCT00783718|143148313|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.6||||0.012|TWO_SIDED|95.0|3.9|31.3||P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||31.3|3.9|0.0120
71822749|NCT00783718|143148313|SUPERIORITY_OR_OTHER||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|16.6|46.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.||46.2|16.6|< 0.0001
71822750|NCT04833855|143148351|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|2.2||0.99|TWO_SIDED|95.0|-4.3|4.4||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 210 mg SC Q4W - Placebo|||4.4|-4.3|0.99
71822751|NCT04833855|143148351|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|2.2||0.6|TWO_SIDED|95.0|-5.4|3.1||Nominal p-value|Repeated measure model|Model parameters: stratification factor (prior anti-IgE status), baseline UAS7, treatment, study week, interaction between treatment and study week.|Tezepelumab 420 mg SC Q2W - Placebo|||3.1|-5.4|0.60
71822752|NCT03682536|143148393|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|2.0|4.8|||Cochran-Mantel-Haenszel|||||4.8|2.0|<.0001
71822753|NCT03682536|143148394|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0003|TWO_SIDED|95.0|1.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|1.4|0.0003
71822754|NCT03682536|143148396|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.8|4.5|||Cochran-Mantel-Haenszel|||||4.5|1.8|<.0001
71822755|NCT03682536|143148398|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|1.6|<.0001
71822756|NCT03682536|143148399|SUPERIORITY||Hazard Ratio (HR)|0.534||||0.0096|TWO_SIDED|95.0|0.33|0.864|||Log Rank||Calculated by Cox proportional hazard model|||0.864|0.330|0.0096
71822757|NCT03682536|143148403|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0007|TWO_SIDED|95.0|1.4|3.8|||Cochran-Mantel-Haenszel|||||3.8|1.4|0.0007
71822758|NCT03682536|143148404|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.6|4.3|||Cochran-Mantel-Haenszel|||||4.3|1.6|<.0001
71822759|NCT03714022|143148532|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.998|||||TWO_SIDED|90.0|0.941|1.058|||||Cohort A vs Cohort B|||1.058|0.941|
71890441|NCT00348140|143302379|SUPERIORITY||Mean Difference (Net)|-0.4||||0.758|TWO_SIDED|95.0|-2.8|2.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||2.1|-2.8|0.758
71822760|NCT03714022|143148533|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.929|||||TWO_SIDED|90.0|0.884|0.976|||||Cohort A vs Cohort B|||0.976|0.884|
71822761|NCT03714022|143148535|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.936|||||TWO_SIDED|90.0|0.891|0.983|||||Cohort A vs Cohort B|||0.983|0.891|
71822762|NCT03714022|143148536|EQUIVALENCE|Equivalence is concluded if the 90% CIs for the ratios of geometric means are contained within 0.8 to 1.25|Ratio of Geometric Means|0.957|||||TWO_SIDED|90.0|0.915|1.001|||||Cohort A vs Cohort B|||1.001|0.915|
71822763|NCT04447820|143148583|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3084|||||||Mixed Model for repeated measures (MMRM)|||||||0.3084
71822764|NCT04447820|143148583|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.593|||||||Mixed Model for repeated measures (MMRM)|||||||0.5930
71822765|NCT04447820|143148584|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9788|||||||MMRM|||||||0.9788
71890442|NCT00348140|143302379|SUPERIORITY||Mean Difference (Net)|-2.0||||0.109|TWO_SIDED|95.0|-4.5|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36||0.5|-4.5|0.109
71701015|NCT02107898|142917626|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.4|||<|0.0001|TWO_SIDED|95.0|-47.0|-35.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.7|-47.0|<0.0001
71701016|NCT02107898|142917627|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.5||||0.0007|TWO_SIDED|95.0|-24.4|-6.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.6|-24.4|0.0007
71701017|NCT02107898|142917628|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|3.7|9.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.3|3.7|<0.0001
71701018|NCT02107898|142917629|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|||<|0.0001|TWO_SIDED|95.0|3.6|9.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.0|3.6|<0.0001
71701019|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.957|||||TWO_SIDED|95.0|0.903|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.|||0.986|0.903|
71701020|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.964|||||TWO_SIDED|95.0|0.908|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.986|0.908|
71701021|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.801|0.928|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.928|0.801|
71701022|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.892|||||TWO_SIDED|95.0|0.804|0.943|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.943|0.804|
71701023|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.839|||||TWO_SIDED|95.0|0.76|0.9|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.900|0.760|
71701024|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.874|||||TWO_SIDED|95.0|0.776|0.933|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.933|0.776|
71701025|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.885|||||TWO_SIDED|95.0|0.811|0.937|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.|||0.937|0.811|
71701026|NCT01401166|142917641|SUPERIORITY_OR_OTHER||Estimated Proportion|0.911|||||TWO_SIDED|95.0|0.827|0.956|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.|||0.956|0.827|
71701027|NCT03483103|142917661|SUPERIORITY||||||<|0.0001||||||One sided P-value is calculated based on the null hypothesis ORR \<= 50.2%|Exact binomial test|||||||<.0001
71701028|NCT01932606|142917718|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
71701029|NCT01932606|142917719|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure.||||0.0003
71701030|NCT01932606|142917719|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure.||||0.01
71701031|NCT01932606|142917719|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure.||||0.002
71701032|NCT01932606|142917719|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between the 2 arms for change in PCWP.||||<0.0001
71701033|NCT01932606|142917720|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
71701034|NCT01932606|142917721|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.11
71701035|NCT01932606|142917721|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean blood pressure.||||0.2
71701036|NCT01932606|142917722|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR.||||0.7
71701037|NCT01932606|142917723|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery compliance.||||0.1
71701038|NCT01932606|142917724|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR.||||0.3
71884464|NCT02171611|143288880|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|186.94|STANDARD_ERROR_OF_MEAN|57.7|||TWO_SIDED|90.0|147.659|236.665|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||236.665|147.659|
71701039|NCT01932606|142917725|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW.||||0.3
71701040|NCT01932606|142917726|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in VO\_2.||||0.8
71701041|NCT01932606|142917727|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for arteriovenous oxygen content difference.||||0.1
71701042|NCT01932606|142917728|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output.||||0.4
71701043|NCT01932606|142917729|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume.||||0.4
71701044|NCT01932606|142917730|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure (exercise).||||0.0002
71701045|NCT01932606|142917730|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure (exercise).||||0.01
71701046|NCT01932606|142917730|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure (exercise).||||0.0002
71701047|NCT01932606|142917730|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PCWP (exercise).||||0.0002
71701048|NCT01932606|142917731|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in heart rate.||||0.3
71701049|NCT01932606|142917732|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.||||0.2
71701050|NCT01932606|142917732|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in diastolic blood pressure.||||0.05
71701051|NCT01932606|142917733|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PVR after study drug (exercise)||||0.3
71701052|NCT01932606|142917734|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in PA compliance after study drug (exercise)||||0.3
71701053|NCT01932606|142917735|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in SVR after study drug (exercise).||||0.007
71701054|NCT01932606|142917736|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in LVSW after study drug (exercise)||||0.0003
71701055|NCT01932606|142917737|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in oxygen consumption (VO\_2) after study drug (exercise).||||0.02
71701056|NCT01932606|142917738|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in arteriovenous oxygen difference after study drug (exercise).||||0.6
71701057|NCT01932606|142917739|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output after study drug (exercise).||||0.002
71701058|NCT01932606|142917740|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume after study drug (exercise).||||0.0002
71761950|NCT00243269|143025807|SUPERIORITY_OR_OTHER|||||||0.932||95.0|||||ANOVA|||The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.||||0.932
71761951|NCT00243269|143025808|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||ANOVA to compare means of the four groups was used.||||0.84
71701059|NCT03881371|142917741|SUPERIORITY||Least-Square Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|-1.643|-0.555||"Analysis was based on a covariance model (ANCOVA) with treatment and centre as independent factors, baseline mean total daily OFF time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.555|-1.643|<.0001
71761952|NCT01396447|143025845|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1292|TWO_SIDED|95.0|-4.3|0.5||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|||0.5|-4.3|0.1292
71701060|NCT03881371|142917742|SUPERIORITY||Least-Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8901|TWO_SIDED|95.0|-0.44|0.382||ANCOVA with treatment and centre as independent factors, baseline NRS measurement as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||0.382|-0.440|0.8901
71701061|NCT03881371|142917743|SUPERIORITY||Least-Square Mean|0.89|STANDARD_ERROR_OF_MEAN|0.315||0.0049|TWO_SIDED|95.0|0.274|1.515||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time measurement as covariate and change from baseline as dependent variable."|ANCOVA|||Treatment difference (Safinamide - Placebo)||1.515|0.274|0.0049
71701062|NCT03881371|142917744|SUPERIORITY||Least-Square Mean|1.07|STANDARD_ERROR_OF_MEAN|0.345||0.0021|TWO_SIDED|95.0|0.392|1.753||"ANCOVA with treatment and centre as independent factors, baseline mean total daily ON time with no/non-troublesome Dyskinesia measurement as covariate and change from baseline as dependent variable."|ANCOVA|||||1.753|0.392|0.0021
71701063|NCT03881371|142917745|SUPERIORITY||Least-Square Mean|-5.99|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.842|-3.141||ANCOVA with treatment and centre as independent factors, baseline UPDRS score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-3.141|-8.842|<.0001
71884465|NCT02171611|143288880|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.59|STANDARD_ERROR_OF_MEAN|54.3|||TWO_SIDED|90.0|133.221|208.326|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.326|133.221|
71701064|NCT03881371|142917746|SUPERIORITY||Least-Square Mean|-1.52|STANDARD_ERROR_OF_MEAN|0.51||0.0033|TWO_SIDED|95.0|-2.521|-0.511||ANCOVA with treatment and centre as independent factors, baseline UPDRS part II (ADL) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-0.511|-2.521|0.0033
71701065|NCT03881371|142917747|SUPERIORITY||Least-Square Mean|-3.8|STANDARD_ERROR_OF_MEAN|0.988||0.0002|TWO_SIDED|95.0|-5.749|-1.856||ANCOVA with treatment and centre as independent factors, baseline UPDRS part III (motor function) score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.856|-5.749|0.0002
71701066|NCT03881371|142917748|SUPERIORITY||Median|0.0||||0.015|TWO_SIDED|95.0|0.0|0.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-S at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||0.000|0.000|0.0150
71701067|NCT03881371|142917749|SUPERIORITY||Median|0.5||||0.0007|TWO_SIDED|95.0|0.0|1.0||Analysis was based on the Wilcoxon-Mann-Whitney test stratified by centre.|Wilcoxon (Mann-Whitney)||Non-parametric 95% confidence interval was presented for the treatment difference in CGI-C score at each post-baseline visit as reported by the Hodges-Lehmann estimator.|Treatment difference (Safinamide - Placebo)||1.000|0.000|0.0007
71701068|NCT03881371|142917750|SUPERIORITY||Least-Square Mean|-3.36|STANDARD_ERROR_OF_MEAN|1.132||0.0033|TWO_SIDED|95.0|-5.589|-1.128||ANCOVA with treatment and centre as independent factor, baseline Summary Index score as covariate and change from baseline as dependent variable.|ANCOVA|||Treatment difference (Safinamide - Placebo)||-1.128|-5.589|0.0033
71701069|NCT00933933|142917752|SUPERIORITY_OR_OTHER||Clinical Specificity|99.77|||||TWO_SIDED|95.0|99.62|99.88|||Exact binomial|||||99.88|99.62|
71701070|NCT00933933|142917753|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.31|100.0|||Exact binomial|||||100.00|94.31|
71701071|NCT00933933|142917753|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|99.63|100.0|||Exact binomial|||||100.00|99.63|
71701072|NCT00933933|142917753|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|98.18|100.0|||Exact binomial|||||100.00|98.18|
71701073|NCT00933933|142917754|SUPERIORITY_OR_OTHER||Clinical Specificity|100.0|||||TWO_SIDED|95.0|99.18|100.0|||Exact binomial|||||100.00|99.18|
71701074|NCT00933933|142917754|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.48|100.0|||Exact binomial|||||100.00|94.48|
71701075|NCT00933933|142917755|SUPERIORITY_OR_OTHER||Clinical Specificity|99.83|||||TWO_SIDED|95.0|99.06|100.0|||Exact binomial|||||100.00|99.06|
71701076|NCT00933933|142917755|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0|||||TWO_SIDED|95.0|94.4|100.0|||Exact binomial|||||100.00|94.40|
71701077|NCT03329001|142917757|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.855|0.9706|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using analysis of variance (ANOVA) model accounting for sequence, participants nested with sequences, period and treatment.|||0.9706|0.8550|
71701078|NCT03329001|142917758|OTHER||Ratio of geometric least square mean|0.9216|||||TWO_SIDED|90.0|0.8631|0.9841|||||Relative bioavailability (AUC\[tablet\]/AUC\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||0.9841|0.8631|
71701079|NCT03329001|142917759|OTHER||Ratio of geometric least square mean|0.9483|||||TWO_SIDED|90.0|0.8489|1.0593|||||Relative bioavailability (Cmax\[tablet\]/Cmax\[capsule\]) was assessed using ANOVA model accounting for sequence, participants nested with sequences, period and treatment.|||1.0593|0.8489|
71701080|NCT03329001|142917764|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-t|Ratio of geometric least square mean|0.9594|||||TWO_SIDED|90.0|0.9199|1.0006|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0006|0.9199|
71701081|NCT03329001|142917765|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for AUC0-inf|Ratio of geometric least square mean|0.9566|||||TWO_SIDED|90.0|0.9164|0.9986|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||0.9986|0.9164|
71701082|NCT03329001|142917766|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval of the ratio of geometric least-squares means of the test (tablet) to reference (capsule) product was within 0.80 - 1.25% for Cmax|Ratio of geometric least square mean|0.9619|||||TWO_SIDED|90.0|0.9124|1.014|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence. Ratio of geometric least square mean of niraparib tablet to niraparib capsule is presented.|||1.0140|0.9124|
71701083|NCT03329001|142917771|OTHER||Ratio of geometric least square mean|1.3154|||||TWO_SIDED|90.0|1.1742|1.4735|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4735|1.1742|
71701084|NCT03329001|142917772|OTHER||Ratio of geometric least square mean|1.2771|||||TWO_SIDED|90.0|1.1537|1.4137|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.4137|1.1537|
71701085|NCT03329001|142917773|OTHER||Ratio of geometric least square mean|1.1129|||||TWO_SIDED|90.0|0.9408|1.3164|||||Analysis was performed using linear mixed model with fixed effects of treatment, period, sequence, and random effect for participant nested within sequence.|||1.3164|0.9408|
71701086|NCT00311168|142917825|SUPERIORITY|A target of an 80% reduction in percentage of ventricular pacing with VIP™ is proposed in this study. In order to achieve an 80% power of detecting an 80% reduction in the percentage of ventricular paced events and using a two group two-sided t-test of equal means, a minimum sample size of 39 patients per group was required. To account for possible withdrawal or loss to follow-up, this study targeted to enroll 100 patients (50 per group).|Mean Difference (Final Values)|-60.2|STANDARD_DEVIATION|19.0|<|0.0001|TWO_SIDED|95.0|-67.5|-52.9|||t-test, 2 sided||Mean difference in the percentage of intrinsic ventricular events is presented as, VIP Off - VIP On.|||-52.9|-67.5|<0.0001
71701087|NCT05850494|142917834|NON_INFERIORITY|Non-inferiority margin of -0.200 L at a one-sided significance level of 0.025.|Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.0136|||TWO_SIDED|95.0|-0.037|0.018||P-Value not applicable since a non-inferiority test was used for the analysis.|Mixed Models Analysis|||||0.018|-0.037|
71701088|NCT00724945|142918016|SUPERIORITY_OR_OTHER||Least Square Mean|-0.08591|STANDARD_ERROR_OF_MEAN|0.008816||||95.0|-0.08591|-0.06857|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.||-0.06857|-0.08591|
71701089|NCT00724945|142918017|SUPERIORITY_OR_OTHER||Least Square Mean|0.02711|STANDARD_ERROR_OF_MEAN|0.008816||||97.5|0.02711|0.04445|||Mixed Models Analysis|||Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.||0.04445|0.02711|
71822766|NCT04447820|143148584|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1314|||||||MMRM|||||||0.1314
71822767|NCT04447820|143148585|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.884|||||||MMRM analysis|||||||0.8840
71822768|NCT04447820|143148585|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.1202|||||||MMRM analysis|||||||0.1202
71822769|NCT04447820|143148586|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.9353|||||||MMRM|||||||0.9353
71822770|NCT04447820|143148586|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3099|||||||MMRM|||||||0.3099
71822771|NCT04447820|143148587|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2098|||||||MMRM|||||||0.2098
71822772|NCT04447820|143148587|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.3688|||||||MMRM|||||||0.3688
71822773|NCT04447820|143148588|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.5647|||||||MMRM|||||||0.5647
71822774|NCT04447820|143148588|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.217|||||||MMRM|||||||0.2170
71822775|NCT04447820|143148589|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.2562|||||||MMRM|||||||0.2562
71890443|NCT00348140|143302379|SUPERIORITY||Mean Difference (Net)|-2.6||||0.05|TWO_SIDED|95.0|-5.2|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.0|-5.2|0.050
71822776|NCT04447820|143148589|NON_INFERIORITY|Approximately 90 participants were planned. Assuming an effect size delta = 0, pooled SD = 21.38, an alpha = 0.05 (1-sided), and a non-inferiority limit of 15%, a sample size of 26 patients per treatment group provided a power of 0.80. In the case that the actual effect size delta was 10%, the power was then 0.2. If the real effect was different, the result less likely showed non-inferiority. To account for any potential drop off, 30 participants in each treatment group, were planned.||||||0.4268|||||||MMRM|||||||0.4268
71822777|NCT04996069|143148614|SUPERIORITY|No power calculation performed.||||||0.45||||||p value threshold is .05|t-test, 2 sided|||||||.45
71822778|NCT00935792|143148618|OTHER||||||||||||||||||Estimated maximum tolerated dose was 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.|||
71822779|NCT04739423|143148624|OTHER||Least Squares Mean|5.4822||||0.0479|TWO_SIDED|95.0|0.0575|10.9069|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14.||10.9069|0.0575|0.0479
71822780|NCT04739423|143148624|OTHER||Least Squares Mean|4.7954||||0.0161|TWO_SIDED|95.0|0.9843|8.6064|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6064|0.9843|0.0161
71822781|NCT04739423|143148624|OTHER||Least Squares Mean|167.29||||0.0237|TWO_SIDED|95.0|25.36|309.23|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||309.23|25.36|0.0237
71822782|NCT04739423|143148624|OTHER||Least Squares Mean|-1.2761||||0.7188|TWO_SIDED|95.0|-9.2424|6.6902|||Mixed Models Analysis|||Between treatment analysis for Accuracy for happiness - change from baseline to Day 14||6.6902|-9.2424|0.7188
71822783|NCT04739423|143148624|OTHER||Least Squares Mean|1.8955||||0.5478|TWO_SIDED|95.0|-4.9026|8.6935|||Mixed Models Analysis|||Between treatment analysis for Accuracy for sadness - Change from baseline to Day 14||8.6935|-4.9026|0.5478
71822784|NCT04739423|143148624|OTHER||Least Squares Mean|-7.52||||0.951|TWO_SIDED|95.0|-291.21|276.17|||Mixed Models Analysis|||Between treatment analysis of Reaction time for anger - change from baseline to Day 7||276.17|-291.21|0.9510
71822785|NCT04739423|143148626|OTHER||Least Squares Mean|0.68||||0.0737|TWO_SIDED|95.0|-0.066|1.432|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.432|-0.066|0.0737
71822786|NCT04739423|143148626|OTHER||Least Squares Mean|1.12||||0.0033|TWO_SIDED|95.0|0.382|1.868|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||1.868|0.382|0.0033
71822787|NCT04739423|143148626|OTHER||Least Squares Mean|1.72||||0.0029|TWO_SIDED|95.0|0.6|2.84|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||2.840|0.600|0.0029
71822788|NCT04739423|143148626|OTHER||Least Squares Mean|1.29||||0.0247|TWO_SIDED|95.0|0.168|2.418|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.418|0.168|0.0247
71822789|NCT04739423|143148626|OTHER||Least Squares Mean|1.69||||0.0016|TWO_SIDED|95.0|0.653|2.732|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.732|0.653|0.0016
71822790|NCT04739423|143148626|OTHER||Least Squares Mean|-0.06||||0.9126|TWO_SIDED|95.0|-1.127|1.009|||Mixed Models Analysis|||Between treatment analysis for Immediate Word recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.009|-1.127|0.9126
71822791|NCT04739423|143148626|OTHER||Least Squares Mean|-0.24||||0.657|TWO_SIDED|95.0|-1.317|0.837|||Mixed Models Analysis|||Between treatment analysis for Immediate Word Recall: number of words - Change from Baseline to Day 14, 4 hours post-dose||0.837|-1.317|0.6570
71822792|NCT04739423|143148626|OTHER||Least Squares Mean|-0.06||||0.9458|TWO_SIDED|95.0|-1.787|1.669|||Mixed Models Analysis|||Between treatment comparison for Delayed Word Recall: number of words - Change from Baseline to Day 1, 4 hours post-dose||1.669|-1.787|0.9458
71822793|NCT04739423|143148626|OTHER||Least Squares Mean|0.97||||0.2327|TWO_SIDED|95.0|-0.642|2.579|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recall: number of words - Change from Baseline to Day 7, 4 hours post-dose||2.579|-0.642|0.2327
71822794|NCT04739423|143148626|OTHER||Least Squares Mean|0.84||||0.4154|TWO_SIDED|95.0|-1.208|2.879|||Mixed Models Analysis|||Between treatment analysis for Delayed Word Recognition: number of words - Change from Baseline to day 7, 4 hours post-dose||2.879|-1.208|0.4154
71822795|NCT04739423|143148627|OTHER||Least Squares Mean|5.06|||<|0.0001|TWO_SIDED|95.0|3.956|6.16|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for Sleeping Heart Rate change from baseline across periods||6.160|3.956|<0.0001
71822796|NCT04739423|143148628|OTHER||Least Squares Mean|1.0||||0.0017|TWO_SIDED|95.0|0.432|1.565|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV change from baseline across periods.||1.565|0.432|0.0017
71822797|NCT04739423|143148629|OTHER||Least Squares Mean|-10.22||||0.0049|TWO_SIDED|95.0|-16.867|-3.567|||Mixed Models Analysis|||Between treatment analysis (active - placebo) for sleeping HRV root mean square of successive differences change from baseline across periods||-3.567|-16.867|0.0049
71822798|NCT02507219|143148681|SUPERIORITY||Slope|0.000055||||0.512|TWO_SIDED|95.0|-0.00011|0.00022|||Mixed Models Analysis||Slope is percent signal change per milligram of ibuprofen.|A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.00022|-0.00011|0.512
71822799|NCT02507219|143148681|SUPERIORITY||Slope|-0.00012||||0.221|TWO_SIDED|95.0|-0.0003|0.000067|||Mixed Models Analysis||Slope is the percent signal change per mg of ibuprofen.|A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.||0.000067|-0.00030|0.221
71822800|NCT00216320|143148690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<.001
71822801|NCT02753530|143148859|SUPERIORITY||Least Square (LS) Mean Difference|-0.99||||0.1146|TWO_SIDED|95.0|-2.23|0.24||Primary Estimand (Treatment Policy)|Mixed Models Analysis|||The baseline observation was the last observation recorded prior to the first dose of study medication. The change from baseline in IBMFRS total score was analyzed using a Mixed Models for Repeated Measures (MMRM) with treatment interacting with visit and trial site as factors. Baseline IBMFRS total score interacting with visit was further included as covariate. An unstructured covariance matrix was assumed.||0.24|-2.23|0.1146
71822802|NCT01125774|143148875|SUPERIORITY_OR_OTHER||Difference in percent incidence|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||2.1|-4.4|
71822803|NCT01125774|143148876|SUPERIORITY_OR_OTHER||Difference in percent incidence|-0.2|||||TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||0.8|-1.4|
71822804|NCT01125774|143148877|SUPERIORITY_OR_OTHER||Difference in percent incidence|0.6|||||TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen||Telcagepant percent incidence versus Placebo percent incidence|||1.6|-0.5|
71884466|NCT02171611|143288881|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|181.6|STANDARD_ERROR_OF_MEAN|53.9|||TWO_SIDED|90.0|145.428|226.776|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||226.776|145.428|
71884467|NCT02171611|143288881|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|166.83|STANDARD_ERROR_OF_MEAN|52.6|||TWO_SIDED|90.0|134.25|207.328|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||207.328|134.25|
71884468|NCT02171611|143288882|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.17|STANDARD_ERROR_OF_MEAN|56.1|||TWO_SIDED|90.0|144.727|229.297|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.297|144.727|
71884469|NCT02171611|143288882|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|160.74|STANDARD_ERROR_OF_MEAN|52.0|||TWO_SIDED|90.0|129.633|199.306|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||199.306|129.633|
71884470|NCT02171611|143288883|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|182.25|STANDARD_ERROR_OF_MEAN|55.7|||TWO_SIDED|90.0|144.993|229.075|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||229.075|144.993|
71884471|NCT02171611|143288883|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means in %|164.01|STANDARD_ERROR_OF_MEAN|51.7|||TWO_SIDED|90.0|132.421|203.14|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||203.14|132.421|
71884472|NCT00487539|143288928|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71884473|NCT00487539|143288928|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71884474|NCT00487539|143288929|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71701090|NCT00724945|142918018|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -0.5.|Mean Difference (Final Values)|0.07407|STANDARD_ERROR_OF_MEAN|0.1279||||97.5|-0.1797|0.07407|||Mixed Models Analysis||Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.|Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.||0.07407|-0.1797|
71884475|NCT00487539|143288929|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71884476|NCT00487539|143288930|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Chi-squared|||||||0.0014
71884477|NCT00487539|143288930|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
71822805|NCT01125774|143148879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.13|TWO_SIDED|95.0|-1.1|0.1||α=0.0499|Longitudinal data analysis (LDA)||Difference is Telcagepant 140 mg versus Placebo|This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM||0.1|-1.1|0.130
71822806|NCT01125774|143148880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.369|TWO_SIDED|95.0|-1.0|0.4||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.4|-1.0|0.369
71945066|NCT01299454|143412834|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.594|||||TWO_SIDED|90.0|0.378|0.934|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.934|0.378|
71945067|NCT01299454|143412834|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.561|||||TWO_SIDED|90.0|0.308|1.022|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||1.022|0.308|
71945068|NCT01299454|143412835|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.558|||||TWO_SIDED|90.0|0.368|0.845|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.845|0.368|
71945069|NCT01299454|143412835|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.516|||||TWO_SIDED|90.0|0.341|0.781|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.781|0.341|
71945070|NCT01299454|143412835|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval \[0.5, 2.0\]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.314|||||TWO_SIDED|90.0|0.195|0.507|||Mixed effect analysis of variance|||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.||0.507|0.195|
71822807|NCT01125774|143148881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
71822808|NCT01125774|143148882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||-0.2|-0.5|<0.001
71822809|NCT01125774|143148883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.393|TWO_SIDED|95.0|-0.4|0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo|||0.2|-0.4|0.393
71884478|NCT00487539|143288931|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
71884479|NCT00487539|143288931|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores||||||<0.0001
71884480|NCT01437397|143288943|SUPERIORITY_OR_OTHER||Least squares mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.073|0.144|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.144|0.073|<0.0001
71884481|NCT01437397|143288943|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.052|0.123|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.123|0.052|<0.0001
71884482|NCT01437397|143288944|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.017||0.01|TWO_SIDED|95.0|0.011|0.079|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.079|0.011|0.010
71884483|NCT01437397|143288944|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.017||0.133|TWO_SIDED|95.0|-0.008|0.06|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates||||0.060|-0.008|0.133
71884484|NCT01437397|143288945|SUPERIORITY_OR_OTHER||Least squares mean difference|1.436|STANDARD_ERROR_OF_MEAN|0.297|<|0.0001|TWO_SIDED|95.0|0.854|2.018|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||2.018|0.854|<0.0001
71822810|NCT01641861|143148897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|7.3||||||||7.3|0.1|
71822811|NCT01641861|143148898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|12.8||||||||12.8|0.9|
71822812|NCT01641861|143148900|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71884485|NCT01437397|143288945|SUPERIORITY_OR_OTHER||Least squares mean difference|1.395|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|0.818|1.972|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||1.972|0.818|<0.0001
71884486|NCT01437397|143288946|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.353|STANDARD_ERROR_OF_MEAN|1.075|<|0.0001|TWO_SIDED|95.0|-6.462|-2.244|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-2.244|-6.462|<0.0001
71884487|NCT01437397|143288946|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.728|STANDARD_ERROR_OF_MEAN|1.066||0.0005|TWO_SIDED|95.0|-5.819|-1.637|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates||||-1.637|-5.819|0.0005
71884488|NCT00903175|143288947|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective was to assess the non-inferiority of everolimus as compared to Sunitinib in terms of PFS-1L \& was based on Bayesian methodology. If the estimated HR for PFS-1L had a value ≤ 1.1, non-inferiority of everolimus to Sunitinib would be declared. Non-inferiority of everolimus compared with Sunitinib as a first-line therapy was not achieved. The estimated HR for PFS-1L was 1.43 which did not satisfy the protocol-defined non-inferiority margin of a HR ≤ 1.1.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.15|1.77||||||||1.77|1.15|
71884489|NCT00371865|143288975|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||.27
71884490|NCT00371865|143288976|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
71884491|NCT00371865|143288977|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||.13
71884492|NCT00371865|143288978|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||.26
71884493|NCT00371865|143288979|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||||||.90
71884494|NCT04817111|143288981|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71884495|NCT04817111|143288983|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
71884496|NCT04817111|143288984|OTHER|Wilcoxon signed-rank test was used to test if the change from pre- vs. post-test outcome is different from zero.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71884497|NCT01328951|143288986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8183|TWO_SIDED|95.0|0.85|1.22|||Log Rank||The HR and 95% confidence interval (CI) were estimated by Cox regression.|Unstratified Analysis.||1.22|0.85|0.8183
71884498|NCT01328951|143288986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5256|TWO_SIDED|95.0|0.87|1.32|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.32|0.87|0.5256
71884499|NCT01328951|143288987|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-0.4||||0.9207|TWO_SIDED|95.0|-8.25|7.45|||Chi-squared|||||7.45|-8.25|0.9207
71884500|NCT01328951|143288989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4759|TWO_SIDED|95.0|0.8|1.11|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Unstratified Analysis.||1.11|0.80|0.4759
71884501|NCT01328951|143288989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1635|TWO_SIDED|95.0|0.72|1.06|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.||1.06|0.72|0.1635
71822813|NCT01641861|143148901|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71822814|NCT00231179|143148919|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|15.0||0.59|TWO_SIDED|95.0|0.31|2.13||Bonferroni corrections were made for multiple comparisons.|t-test, 2 sided|||We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).||2.13|0.31|0.59
71822815|NCT00231179|143148920|NON_INFERIORITY_OR_EQUIVALENCE|Please see earlier power calculation.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0||0.72|TWO_SIDED|95.0|||||Chi-squared|||||||0.72
71822816|NCT00231179|143148921|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|10.0|STANDARD_ERROR_OF_MEAN|5.0|<|0.01|TWO_SIDED|95.0|||||Chi-squared|||||||<0.01
71884502|NCT01328951|143288990|SUPERIORITY_OR_OTHER||Difference in Event-Free Rate|-2.89||||0.4069|TWO_SIDED|95.0|-9.7|3.93|||Chi-squared|||||3.93|-9.70|0.4069
71884503|NCT01328951|143288991|SUPERIORITY_OR_OTHER||Difference in Response Rate|2.78||||0.1097|TWO_SIDED|95.0|-0.78|6.35|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||6.35|-0.78|0.1097
71884504|NCT01328951|143288991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.87|3.72|||||The 95% CI for OR was constructed using the Wald method.|||3.72|0.87|
71884505|NCT01328951|143288993|SUPERIORITY_OR_OTHER||Difference in Response Rate|1.99||||0.6062|TWO_SIDED|95.0|-5.74|9.72|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.|||9.72|-5.74|0.6062
71884506|NCT01328951|143288993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.79|1.49|||||The 95% CI for OR was constructed using the Wald method.|||1.49|0.79|
71884507|NCT00970853|143288994|NON_INFERIORITY_OR_EQUIVALENCE|The original sample for this study (N=302) was sufficient for an 80% detection of differences in means of at least 1/2 standard deviation. This analysis presents the results of the follow-up of the original sample.||||||0.39||||||non-adjusted for multiple comparisons|t-test, 2 sided|||||||0.39
71884508|NCT00970853|143288995|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.99|||||||t-test, 2 sided|||||||.99
71822817|NCT00231179|143148922|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71822818|NCT00231179|143148923|NON_INFERIORITY_OR_EQUIVALENCE|See previous.|Hazard Ratio (HR)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.64|TWO_SIDED|95.0|||||Chi-squared|||||||0.64
71822819|NCT02028884|143148937|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0184|TWO_SIDED|95.0|0.16|0.88|||Log Rank|||Stratified by Baseline annualized relapse rate (ARR: 1, \> 1) and geographic region (Asia, EU/Other).||0.88|0.16|0.0184
71822820|NCT02028884|143148938|SUPERIORITY||Mean Difference (Final Values)|6.376|STANDARD_ERROR_OF_MEAN|3.344||0.0602|TWO_SIDED|95.0|-0.28|13.033|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||13.033|-0.280|0.0602
71822821|NCT02028884|143148939|SUPERIORITY||Mean Difference (Final Values)|-2.089|STANDARD_ERROR_OF_MEAN|1.338||0.1224|TWO_SIDED|95.0|-4.752|0.574|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||0.574|-4.752|0.1224
71822822|NCT00354029|143148968|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
71822823|NCT00826280|143148973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71822824|NCT00826280|143148973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71822825|NCT00826280|143148973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71822826|NCT00826280|143148973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9328||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.9328
71822827|NCT00826280|143148974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0011
71822828|NCT00826280|143148974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0034||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0034
71822829|NCT00826280|143148974|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71822830|NCT00826280|143148974|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5902||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5902
71822831|NCT00826280|143148975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0037
71822832|NCT00826280|143148975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0089
71822833|NCT00826280|143148975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.0016
71822834|NCT00826280|143148975|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5654||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||0.5654
71822835|NCT00826280|143148976|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71822836|NCT00826280|143148976|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71822837|NCT00826280|143148976|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||<0.001
71884509|NCT00970853|143288996|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.16|||||||t-test, 2 sided|||||||0.16
71884510|NCT00970853|143288997|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.4|||||||t-test, 2 sided|||||||.40
71884511|NCT00970853|143288998|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.56|||||||t-test, 2 sided|||||||.56
71884512|NCT00970853|143288999|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.34|||||||t-test, 2 sided|||||||.34
71884513|NCT00970853|143289000|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.85|||||||t-test, 2 sided|||||||.85
71884514|NCT00970853|143289001|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.61|||||||t-test, 2 sided|||||||.61
71884515|NCT00970853|143289002|NON_INFERIORITY_OR_EQUIVALENCE|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.67|||||||t-test, 2 sided|||||||.67
71701091|NCT05352763|142918124|OTHER|No statistical analysis performed|||||||||||||||||The classical summary of count and percentages will be provided for basic safety tabulations and dispositions as appropriate. All data will be presented in by-subject data listings. No inferential statistics will be produced.|||
71822838|NCT00826280|143148976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4246||95.0||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.||||.4246
71884516|NCT00271817|143289017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-41.4|-35.4||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-35.4|-41.4|<0.001
71701092|NCT02469233|142918215|SUPERIORITY||Time by treatment interaction coeff.|-3.18||||0.025|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.025
71884517|NCT00271817|143289018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-36.5|-30.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-30.6|-36.5|<0.001
71884518|NCT00271817|143289019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|18.8|25.3||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.3|18.8|<0.001
71884519|NCT00271817|143289020|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-18.7|||<|0.001||95.0|-22.6|-14.7||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender|"Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-14.7|-22.6|<0.001
71884520|NCT00271817|143289021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|18.0|25.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||25.0|18.0|<0.001
71884521|NCT00271817|143289022|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|||<|0.001||95.0|-21.8|-13.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender.|"Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic."|||-13.6|-21.8|<0.001
71884522|NCT00271817|143289023|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-10.4|-4.2||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-4.2|-10.4|<0.001
71884523|NCT00271817|143289024|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.6||0.004||95.0|-8.0|-1.5||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-1.5|-8.0|0.004
71884524|NCT00271817|143289025|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.7|-2.1||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin|||-2.1|-7.7|<0.001
71884525|NCT00271817|143289026|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.4|-5.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin|||-5.0|-10.4|<0.001
71884526|NCT00931359|143289027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Factors of treatment group and analysis center were considered||||||<0.001
71884527|NCT00931359|143289028|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||||||0.019
71945071|NCT03965091|143412847|OTHER||Least square (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7963|TWO_SIDED|95.0|-0.46|0.6|||Mixed Models Analysis|||Analysis was performed using a Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.60|-0.46|0.7963
71945072|NCT03965091|143412847|OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.8629|TWO_SIDED|95.0|-0.48|0.58|||Mixed Models Analysis|||Analysis was performed using an MMRM model with change from baseline in the weekly average of the daily average PI-NRS score over the past 24 hours at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 as the dependent variable, sex, age group at FM onset, week, treatment, and treatment-by-week interaction as fixed factors, and baseline average of the daily average PI-NRS score as a covariate.||0.58|-0.48|0.8629
71945073|NCT00982397|143412867|SUPERIORITY_OR_OTHER||percentage of participants|98.5|||||TWO_SIDED|95.0|97.9|99.0|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.||99.0|97.9|
71945074|NCT00982397|143412867|SUPERIORITY_OR_OTHER||percentage of participants|97.5|||||TWO_SIDED|95.0|96.1|98.5|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.||98.5|96.1|
71945075|NCT00982397|143412868|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison against a performance criterion of 10%.|Exact Binomial|||Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.||||<0.0001
71945076|NCT00982397|143412869|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.|Confidence interval and hypothesis test|||P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.||||<0.0001
71945077|NCT00982397|143412870|NON_INFERIORITY_OR_EQUIVALENCE|Ho: p1 ≤ p2 - 0.05 Ha: p1 \> p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.|Risk Difference (RD)|0.0||||0.0013|TWO_SIDED|90.0|-2.7|2.7||P-Value is for non-inferiority|Farrington-Manning||The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.|The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.||2.7|-2.7|0.0013
71945078|NCT02363803|143412871|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired t-test||||||0.03
71945079|NCT03140631|143412876|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71945080|NCT03140631|143412877|SUPERIORITY|||||||0.74|||||||Fisher Exact|||number of participants who experienced a vascular access site complication at 90 days||||0.74
71884528|NCT01295216|143289050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-2.15|1.4|||||Systolic blood pressure at 12 months|||1.40|-2.15|
71945081|NCT04405570|143412913|SUPERIORITY|||||||0.5551|||||||Log Rank|||||||0.5551
71884529|NCT01295216|143289050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-1.29|1.32|||||Diastolic blood pressure for 12 months|||1.32|-1.29|
71884530|NCT03124563|143289056|SUPERIORITY||||||=|0.006|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||=.006
71884531|NCT03124563|143289057|SUPERIORITY|||||||0.034|||||||Mixed Models Analysis|Controlling for age, gender, and functional health||||||.034
71884532|NCT03124563|143289058|SUPERIORITY|||||||0.065|||||||Mixed Models Analysis|Controlling for age, gender, and education||||||.065
71945082|NCT04405570|143412913|SUPERIORITY|||||||0.727|||||||Log Rank|||||||0.7270
71945083|NCT04405570|143412913|SUPERIORITY|||||||0.0128|||||||Log Rank|||||||0.0128
71945084|NCT04499963|143412917|SUPERIORITY|||||||0.984|||||||t-test, 2 sided|||We compared he ALSFRS-R slope (not the actual score) of the patients in our open label treatment versus the historical controls.||||0.984
71945085|NCT04499963|143412922|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945086|NCT04499963|143412923|OTHER||||||>|0.5||||||Alpha Diversity|Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.5
71945087|NCT04499963|143412924|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945088|NCT04499963|143412925|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945089|NCT04499963|143412926|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945090|NCT04499963|143412927|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945091|NCT04499963|143412928|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945092|NCT04499963|143412929|OTHER||||||>|0.05|||||||Kruskal-Wallis|||Open Label Arm participant samples from baseline, month 1, and month 6.||||>0.05
71945093|NCT03226522|143412946|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
71945094|NCT03226522|143412946|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71945095|NCT00984126|143412947|SUPERIORITY_OR_OTHER||Incidence rate|0.0|||||ONE_SIDED|95.0||1.4||||||A one-sided 95% upper confidence limit was based on an exact calculation for a binomial distribution.||1.4||
71945096|NCT01001208|143412951|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||<0.0001
71945097|NCT01001208|143412952|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71945098|NCT01001208|143412953|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71945099|NCT01001208|143412954|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71945100|NCT01001208|143412955|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71945101|NCT01001208|143412956|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71945102|NCT01001208|143412957|SUPERIORITY_OR_OTHER|||||||0.0348||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0348
71945103|NCT01001208|143412958|SUPERIORITY_OR_OTHER|||||||0.0112||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.0112
71945104|NCT01001208|143412959|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
71945105|NCT01001208|143412960|SUPERIORITY_OR_OTHER|||||||0.1995||95.0||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group||||||0.1995
71945106|NCT01864174|143412961|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study provided 90% power to demonstrate noninferiority in change from baseline mean HbA1c at Week 24, with an assumed standard deviation (SD) of 1.0%, a non-inferiority margin of 0.3%, and 2-sided alpha of 0.05 for the primary comparison|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.0687|||TWO_SIDED|95.0|-0.1|0.17|||||METFORMIN XR VS METFORMIN IR|||0.17|-0.10|
71945107|NCT01723397|143412968|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon signed-rank test|||||||0.8
71945108|NCT02009163|143412991|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value based on a log-rank test, stratified by 4-week cessation status (Yes, No). 4-week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization.|Log Rank|||||||<0.001
71945109|NCT02009163|143412992|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.42||Nominal P-value not adjusted for multiplicity.|mixed- effects model for repeated measur|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-0.42|-0.81|<0.001
71945110|NCT02009163|143412993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Unadjusted P-value for the difference in distribution between treatment groups in CGI-S.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGI-S as the covariate.||||||<0.001
71945111|NCT02009163|143412994|SUPERIORITY_OR_OTHER_LEGACY||difference in LS mean|-5.6|||<|0.001|TWO_SIDED|95.0|-7.2|-3.9||Nominal P-value not adjusted for multiplicity.|mixed-effects model for repeated measure|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.||||-3.9|-7.2|<0.001
71945112|NCT00833586|143413008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|95.1||||||90.0|85.8|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.4|85.8|
71945113|NCT00833586|143413009|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.9||||||90.0|82.7|118.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||118.4|82.7|
71945114|NCT00833586|143413010|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|102.4||||||90.0|95.0|110.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.5|95.0|
71945115|NCT00095212|143413023|SUPERIORITY_OR_OTHER|||||||0.04|||||||longitudinal linear mixed effects model|||||||0.04
71945116|NCT00095212|143413024|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal linear mixed effects model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
71945117|NCT00095212|143413025|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.02
71945118|NCT00095212|143413026|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.||||0.01
71945119|NCT00095212|143413027|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
71945120|NCT00095212|143413028|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||||||0.29
71945121|NCT00095212|143413029|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared|||||||0.75
71945122|NCT00095212|143413030|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
71945123|NCT00095212|143413031|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
71945124|NCT00095212|143413032|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
71945125|NCT00095212|143413033|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
71945126|NCT01379664|143413045|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.06||||0.24|TWO_SIDED|95.0|0.97|1.16|||Wilcoxon (Mann-Whitney)|||||1.16|0.97|0.24
71945127|NCT01379664|143413046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.87|TWO_SIDED|95.0|-0.23|0.19|||Generalized estimating equation model|Generalized estimating equation model weighted by inverse propensity score||||0.19|-0.23|0.87
71945128|NCT01379664|143413047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.74|TWO_SIDED|95.0|-4.7|3.3|||Generalized estimating equation model|Generalized estimating equation model weighted by propensity score||||3.3|-4.7|0.74
71945129|NCT04189848|143413136|OTHER|Treatment comparison|Treatment difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.6|||ANOVA|||Intensity of injection site pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||-3.6|-8.2|<0.0001
71945130|NCT00819741|143413137|NON_INFERIORITY_OR_EQUIVALENCE|"If non-inferiority was shown (that was if H0 was rejected), then superiority of repaglinide and metformin combination therapy compared to repaglinide monotherapy would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.~The non-inferiority margin for HbA1c was set to 0.4%."|Estimated treatment difference, LS Mean|-0.302|STANDARD_ERROR_OF_MEAN|0.0096||||95.0|-0.491|-0.114|||ANCOVA|||"The non-inferiority margin for HbA1c was set to 0.4%.~The null hypothesis (H0) was:~H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4%~Against the alternative hypothesis (H1):~H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment - HbA1c of repaglinide monotherapy after 16 weeks of treatment \<0.4%"||-0.114|-0.491|
71945131|NCT00119015|143413152|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8
71945132|NCT00119015|143413153|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.70
71945133|NCT00119015|143413154|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
71945134|NCT00119015|143413155|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.48
71945135|NCT00119015|143413156|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.99
71945136|NCT03235739|143413159|SUPERIORITY|multiple imputation for longitudinal data was conducted to impute the missing data for the primary outcome. The final results were obtained from pooling results from 10 imputed complete case data set.|geometric mean ratio|0.9||||0.84|TWO_SIDED|95.0|0.32|2.55|||Mixed Models Analysis|||||2.55|0.32|0.84
71945137|NCT03235739|143413159|SUPERIORITY|A sensitivity analysis using complete case analysis|geometric mean ratio|0.82||||0.73|TWO_SIDED|95.0|0.26|2.56|||Mixed Models Analysis|||||2.56|0.26|0.73
71945138|NCT03235739|143413160|SUPERIORITY||geometric mean ratio|1.02||||0.91|TWO_SIDED|98.3|0.63|1.67|||Mixed Models Analysis|||||1.67|0.63|0.91
71945139|NCT03235739|143413161|SUPERIORITY||Risk Ratio (RR)|2.58||||0.012|TWO_SIDED|98.3|0.98|6.8|||Chi-squared|||||6.80|0.98|0.012
71945140|NCT03235739|143413162|SUPERIORITY||median of differences|-5.0||||0.08|TWO_SIDED|98.3|-12.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-12|0.08
71945141|NCT02847650|143413163|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.26||0.0407|TWO_SIDED|90.0|-8.6|-1.0|||Mixed Models Analysis|||||-1.0|-8.6|0.0407
71945142|NCT03818581|143413175|SUPERIORITY|||||||0.15|||||||SPCD analysis|||||||0.15
71945143|NCT01281501|143413204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|5.0||0.6|TWO_SIDED|95.0|-12.7|7.4|||t-test, 2 sided|||Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.||7.4|-12.7|0.6
71945144|NCT00834522|143413209|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.79||||||90.0|99.4|108.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.37|99.40|
71945145|NCT00834522|143413210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.37||||||90.0|97.04|112.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.25|97.04|
71945146|NCT00834522|143413211|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.22||||||90.0|96.9|112.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.08|96.90|
71945147|NCT02996591|143413241|OTHER||generalized estimating equations method|45.0||||0.038|TWO_SIDED||||||Regression, Logistic|||||||.038
71945148|NCT02996591|143413241|OTHER|Bang blinding index|||||<|0.001|||||||Bang Blinding Index|95% confidence interval||||||<.001
71945149|NCT00461786|143413253|SUPERIORITY_OR_OTHER||Overall Response Rate|21.0||||||95.0|10.5|35.0||||||Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.||35.0|10.5|
71945150|NCT00835991|143413258|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|114.05||||||90.0|107.26|121.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.27|107.26|
71945151|NCT00835991|143413259|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.63||||||90.0|97.59|103.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.76|97.59|
71884533|NCT03124563|143289059|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.308
71884534|NCT03124563|143289060|SUPERIORITY|||||||0.349|||||||ANOVA|||||||.349
71884535|NCT03124563|143289061|SUPERIORITY|||||||0.022|||||||Mixed Models Analysis|Controlling for age, gender, and level of education||||||.022
71884536|NCT03036293|143289088|SUPERIORITY||Mean Difference (Final Values)|1.56||||0.0055|TWO_SIDED|98.33|0.217|2.91|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.91|0.217|0.0055
71884537|NCT03036293|143289088|SUPERIORITY||Mean Difference (Final Values)|2.56|||<|0.0001|TWO_SIDED|98.33|1.1|3.96|||ANCOVA|Baseline score used as covariate. Yeo-Johnson transformation with λ=1,09 was applied. Statistical inference performed for transformed values.|estimate and CL are backtransformed|Mean score differences (begin-end) were compared||3.96|1.1|<0.0001
71884538|NCT03036293|143289088|EQUIVALENCE|equivalence limits were prespecified as \[-2.763; 2.763\]|Mean Difference (Net)|0.89||||0.0008|TWO_SIDED|98.33|-0.64|2.33|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.33|-0.64|0.0008
71884539|NCT03036293|143289089|SUPERIORITY||Mean Difference (Net)|0.6||||0.08|TWO_SIDED|95.0|-0.08|1.54|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.54|-0.08|0.08
71884540|NCT03036293|143289089|SUPERIORITY||Mean Difference (Net)|0.76||||0.044|TWO_SIDED|95.0|0.02|1.66|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.66|0.02|0.044
71884541|NCT03036293|143289090|SUPERIORITY||Mean Difference (Net)|0.69||||0.21|TWO_SIDED|95.0|-0.4|1.78|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||1.78|-0.4|0.21
71884542|NCT03036293|143289090|SUPERIORITY||Mean Difference (Net)|1.19||||0.027|TWO_SIDED|95.0|0.14|2.26|||ANCOVA|Baseline score used as covariate||Mean score differences (begin-end) were compared||2.26|0.14|0.027
71884543|NCT03036293|143289091|SUPERIORITY||Odds Ratio (OR)|1.36||||0.065|TWO_SIDED|95.0|0.98|1.89|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.89|0.98|0.065
71884544|NCT03036293|143289091|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0015|TWO_SIDED|95.0|1.22|2.33|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||2.33|1.22|0.0015
71884545|NCT03036293|143289091|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Week 4 frequencies comparison||||0.7
71884546|NCT03036293|143289091|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 8 frequencies comparison||||1
71884547|NCT03036293|143289091|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Week 12 frequencies comparison||||0.01
71884548|NCT03036293|143289091|SUPERIORITY|||||||0.57|||||||Fisher Exact|||Week 4 frequencies comparison||||0.57
71884549|NCT03036293|143289091|SUPERIORITY|||||||0.25|||||||Fisher Exact|||Week 8 frequencies comparison||||0.25
71884550|NCT03036293|143289091|SUPERIORITY|||||||0.001|||||||Fisher Exact|||Week 12 frequencies comparison||||0.001
71884551|NCT03036293|143289092|SUPERIORITY||Odds Ratio (OR)|0.88||||0.46|TWO_SIDED|95.0|0.64|1.23|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.23|0.64|0.46
71884552|NCT03036293|143289092|SUPERIORITY||Odds Ratio (OR)|1.27||||0.17|TWO_SIDED|95.0|0.9|1.79|||Cochran-Mantel-Haenszel||Bigger OR is better|Common OR of event analysis||1.79|0.9|0.17
71884553|NCT03036293|143289092|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Week 4 frequencies comparison||||0.38
71884554|NCT03036293|143289092|SUPERIORITY|||||||0.67|||||||Fisher Exact|||Week 8 frequencies comparison||||0.67
71884555|NCT03036293|143289092|SUPERIORITY|||||||0.85|||||||Fisher Exact|||Week 12 frequencies comparison||||0.85
71884556|NCT03036293|143289092|SUPERIORITY|||||||0.71|||||||Fisher Exact|||Week 4 frequencies comparison||||0.71
71884557|NCT03036293|143289092|SUPERIORITY|||||||0.29|||||||Fisher Exact|||Week 8 frequencies comparison||||0.29
71884558|NCT03036293|143289092|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Week 12 frequencies comparison||||0.007
71884559|NCT03036293|143289093|SUPERIORITY||Median Difference (Net)|0.00002||||0.314|TWO_SIDED|95.0|-0.00002|0.33|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||0.33|-0.00002|0.314
71884560|NCT03036293|143289093|SUPERIORITY||Median Difference (Net)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator for location difference provided|Median changes (begin-end) within groups are compared||1|0|0.031
71884561|NCT03036293|143289094|SUPERIORITY||Median Difference (Net)|-0.00001||||0.0021|TWO_SIDED|95.0|-3.0|-0.00001|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00001|-3|0.0021
71884562|NCT03036293|143289094|SUPERIORITY||Median Difference (Net)|-0.00002||||0.0056|TWO_SIDED|95.0|-1.0|-0.00002|||Wilcoxon (Mann-Whitney)||Lower is better|||-0.00002|-1|0.0056
71884563|NCT00691483|143289100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.03|||<|0.0001|TWO_SIDED|95.0|3.8|9.56||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||9.56|3.80|<0.0001
71890444|NCT00348140|143302379|SUPERIORITY||Mean Difference (Net)|-3.4||||0.009|TWO_SIDED|95.0|-6.0|-0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48||-0.9|-6.0|0.009
71822839|NCT02688621|143149006|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||The study was designed to detect a 2.2-kg group weight loss difference between groups with a standard deviation of 5.8 kg,4,5 a 5% Type I error rate, and 80% power. To adjust for possible clustering effects in this nested design, the adjusted variance estimate was increased to 7.67, calculated using a conservative intraclass correlation coefficient of 0.05.||||<.01
71822840|NCT04003974|143149106|OTHER|Mean DUX4 activity was derived for each participant at each time point (Baseline and post-Baseline) based on normalized gene expression values for the 6-gene panel. Changes from Baseline to post-Baseline were analyzed using an ANCOVA model.|Least square mean difference|0.4284||||0.5621|TWO_SIDED|95.0|-1.0376|1.8945|||ANCOVA||Results are expressed as difference in Least-Squares (LS) means of the changes from Baseline to post-Baseline in DUX4 activity for each group, losmapimod and placebo.|||1.8945|-1.0376|0.5621
71822841|NCT00335153|143149144|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822842|NCT00335153|143149145|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
71822843|NCT00335153|143149146|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822844|NCT00335153|143149147|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822845|NCT00335153|143149148|SUPERIORITY_OR_OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
71822846|NCT00335153|143149149|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822847|NCT00335153|143149150|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822848|NCT00335153|143149151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822849|NCT00335153|143149152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822850|NCT00335153|143149153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822851|NCT00335153|143149154|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71890445|NCT00348140|143302380|SUPERIORITY||Mean Difference (Net)|0.01||||0.662|TWO_SIDED|95.0|-0.02|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.03|-0.02|0.662
71822852|NCT00335153|143149155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822853|NCT00335153|143149156|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822854|NCT00335153|143149157|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822855|NCT00335153|143149158|SUPERIORITY_OR_OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
71822856|NCT00335153|143149159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822857|NCT00335153|143149160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822858|NCT00335153|143149161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822859|NCT00335153|143149162|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822860|NCT00335153|143149163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71822861|NCT00335153|143149164|SUPERIORITY_OR_OTHER|||||||0.824|||||||t-test, 2 sided|||||||0.824
71822862|NCT03688542|143149167|SUPERIORITY||Slope|-1.4|||<|0.05|TWO_SIDED|95.0|-3.8|1.0|||Regression, Linear|Dependant variable = follow-up value; adjusted for baseline value, canton, avg number of residents, mission||||1.0|-3.8|<0.05
71822863|NCT03688542|143149168|SUPERIORITY||Slope|-0.18|||<|0.05|TWO_SIDED|95.0|-0.39|0.03|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.03|-0.39|<0.05
71822864|NCT03688542|143149169|SUPERIORITY||Slope|-0.035|||<|0.05|TWO_SIDED|95.0|-0.095|0.025|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||0.025|-0.095|<0.05
71822865|NCT03688542|143149170|SUPERIORITY||Slope|-0.237|||<|0.05|TWO_SIDED|95.0|-0.435|-0.04|||Regression, Linear|Dependant variable = number of PIM DDD at follow-up, adjusted for baseline value, canton, avg number of residents, mission||||-0.040|-0.435|<0.05
71822866|NCT03688542|143149171|SUPERIORITY||Slope|1.55|||<|0.05|TWO_SIDED|95.0|0.164|2.938|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||2.938|0.164|<0.05
71822867|NCT03688542|143149172|SUPERIORITY||Slope|-12.7|||<|0.05|TWO_SIDED|95.0|-21.5|-4.0|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents, interaction between mission and group.||||-4.0|-21.5|<0.05
71822868|NCT03688542|143149173|SUPERIORITY||Slope|-0.165|||<|0.05|TWO_SIDED|95.0|-0.754|0.424|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||0.424|-0.754|<0.05
71822869|NCT03688542|143149174|SUPERIORITY||Slope|-4.2|||<|0.05|TWO_SIDED|95.0|-16.0|7.6|||Regression, Linear|Dependent variable = follow-up value, adjusted for baseline value, canton, avg number of residents||||7.6|-16.0|<0.05
71822870|NCT02478359|143149175|SUPERIORITY||Odds Ratio (OR)|1.09||||0.33|TWO_SIDED|95.0|0.92|1.28|||Regression, Logistic|||||1.28|0.92|0.33
71822871|NCT02478359|143149176|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.77|1.36|||Regression, Logistic|||||1.36|0.77|0.88
71822872|NCT02478359|143149177|SUPERIORITY||Odds Ratio (OR)|1.05||||0.53|TWO_SIDED|95.0|0.89|1.24|||Regression, Logistic|||||1.24|0.89|0.53
71822873|NCT02478359|143149178|SUPERIORITY||Odds Ratio (OR)|1.03||||0.73|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic|||||1.20|0.88|0.73
71890446|NCT00348140|143302380|SUPERIORITY||Mean Difference (Net)|-0.01||||0.503|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12||0.02|-0.03|0.503
71890447|NCT00348140|143302380|SUPERIORITY||Mean Difference (Net)|0.0||||0.892|TWO_SIDED|95.0|-0.03|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.03|-0.03|0.892
71945152|NCT00835991|143413260|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.36||||||90.0|98.32|104.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.48|98.32|
71945153|NCT00835991|143413261|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.05||||||90.0|94.31|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|94.31|
71822874|NCT02478359|143149179|SUPERIORITY||Odds Ratio (OR)|1.13||||0.21|TWO_SIDED|95.0|0.93|1.37|||Regression, Logistic|||||1.37|0.93|0.21
71822875|NCT02478359|143149180|SUPERIORITY||Odds Ratio (OR)|1.1||||0.26|TWO_SIDED|95.0|0.93|1.31|||Regression, Logistic|||||1.31|0.93|0.26
71822876|NCT02478359|143149181|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71822877|NCT02478359|143149182|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
71822878|NCT02478359|143149183|SUPERIORITY|||||||0.34||||||adjusted p values|Regression, Logistic|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.34
71822879|NCT02478359|143149184|SUPERIORITY|||||||0.6|||||||Regression, Linear|||||||0.60
71822880|NCT02478359|143149185|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
71822881|NCT02478359|143149186|SUPERIORITY|||||||0.47|||||||Regression, Linear|||||||0.47
71822882|NCT02478359|143149187|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
71822883|NCT02478359|143149188|SUPERIORITY|||||||0.87||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.87
71890448|NCT00348140|143302380|SUPERIORITY||Mean Difference (Net)|-0.03||||0.083|TWO_SIDED|95.0|-0.05|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36||0.00|-0.05|0.083
71822884|NCT02478359|143149189|SUPERIORITY|||||||0.7||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.70
71822885|NCT02478359|143149190|SUPERIORITY|||||||0.35|||||||Regression, Linear|Adjusted P Values||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.35
71822886|NCT02478359|143149191|SUPERIORITY|||||||0.09||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.09
71822887|NCT02478359|143149192|SUPERIORITY|||||||0.82||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.82
71822888|NCT02478359|143149193|SUPERIORITY|||||||0.16||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.16
71822889|NCT02478359|143149194|SUPERIORITY|||||||0.86||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site||||0.86
71822890|NCT02478359|143149195|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71822891|NCT02478359|143149196|SUPERIORITY||Odds Ratio (OR)|1.05||||0.69|TWO_SIDED|95.0|0.82|1.35|||Regression, Logistic|||||1.35|0.82|0.69
71890449|NCT00348140|143302380|SUPERIORITY||Mean Difference (Net)|-0.01||||0.366|TWO_SIDED|95.0|-0.05|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.05|0.366
71890450|NCT00348140|143302380|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48||0.02|-0.03|0.769
71890451|NCT00348140|143302381|SUPERIORITY||Mean Difference (Net)|-0.2||||0.529|TWO_SIDED|95.0|-0.7|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.3|-0.7|0.529
71890452|NCT00348140|143302381|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12||0.4|-0.7|0.620
71945154|NCT00835991|143413262|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05|Test/Ref Ratio of LS Means x 100|96.55||||||90.0|93.85|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.32|93.85|
71822892|NCT02478359|143149197|SUPERIORITY||Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.35|1.11|||Regression, Logistic|||||1.11|0.35|0.11
71890453|NCT00348140|143302381|SUPERIORITY||Mean Difference (Net)|-0.4||||0.284|TWO_SIDED|95.0|-1.0|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.3|-1.0|0.284
71822893|NCT02478359|143149198|SUPERIORITY||Odds Ratio (OR)|0.84||||0.21|TWO_SIDED|95.0|0.65|1.1|||Regression, Logistic|||||1.10|0.65|0.21
71822894|NCT02478359|143149199|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6|TWO_SIDED|95.0|0.84|1.36|||Regression, Logistic|||||1.36|0.84|0.60
71890454|NCT00348140|143302381|SUPERIORITY||Mean Difference (Net)|0.2||||0.488|TWO_SIDED|95.0|-0.4|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36||0.9|-0.4|0.488
71890455|NCT00348140|143302381|SUPERIORITY||Mean Difference (Net)|0.2||||0.549|TWO_SIDED|95.0|-0.5|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 48||1.0|-0.5|0.549
71890456|NCT00348140|143302381|SUPERIORITY||Mean Difference (Net)|0.1||||0.78|TWO_SIDED|95.0|-0.6|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.9|-0.6|0.780
71890457|NCT00348140|143302382|SUPERIORITY||Mean Difference (Net)|-0.6||||0.106|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.106
71890458|NCT00348140|143302382|SUPERIORITY||Mean Difference (Net)|-0.4||||0.229|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||||0.3|-1.2|0.229
71890459|NCT00348140|143302383|SUPERIORITY||Mean Difference (Net)|-0.1||||0.324|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.324
71890460|NCT00348140|143302383|SUPERIORITY||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.987
71890461|NCT00348140|143302384|SUPERIORITY||Mean Difference (Net)|0.05||||0.038|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.10|0.00|0.038
71890462|NCT00348140|143302384|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||ANCOVA|||||0.18|0.08|<0.001
71890463|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|-0.1||||0.748|TWO_SIDED|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.3|-0.4|0.748
71890464|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.1||||0.617|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8||0.5|-0.3|0.617
71890465|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|-0.1||||0.708|TWO_SIDED|95.0|-0.5|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.3|-0.5|0.708
71890466|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16||0.2|-0.5|0.400
71890467|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.0||||0.928|TWO_SIDED|95.0|-0.4|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.4|-0.4|0.928
71890468|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.3||||0.178|TWO_SIDED|95.0|-0.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24||0.7|-0.1|0.178
71890469|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.1||||0.626|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.626
71890470|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.1||||0.608|TWO_SIDED|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36||0.5|-0.3|0.608
71890471|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.0||||0.865|TWO_SIDED|95.0|-0.5|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.4|-0.5|0.865
71945155|NCT00835991|143413263|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.44||||||90.0|93.71|99.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.25|93.71|
71945156|NCT02149420|143413264|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_DEVIATION|2.058||0.678|TWO_SIDED|95.0|-5.007|3.18|||repeated measures Bayesian analysis|with baseline as a covariate||Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.||3.180|-5.007|0.678
71945157|NCT02246920|143413370|EQUIVALENCE|Equivalence is established if the 90% confidence interval is contained within 80.00-125.00%.|T/R Ls Mean Ratio|108.09|||||TWO_SIDED|90.0|94.09|124.4||||||||124.40|94.09|
71945158|NCT02246920|143413371|EQUIVALENCE|Equivalence is demonstrated when the 90% confidence interval is contained within 80.00-125.00%.|T/R LS Mean Ratio|107.0|||||TWO_SIDED|90.0|92.42|124.09||||||||124.09|92.42|
71945159|NCT02246920|143413372|SUPERIORITY|||||||0.0028|||||||ANCOVA|||||||0.0028
71945160|NCT02246920|143413372|SUPERIORITY|||||||0.0169|||||||ANCOVA|||||||0.0169
71945161|NCT00904215|143413423|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Student Paired t-test|||||||<0.0001
71945162|NCT00904215|143413424|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
71945163|NCT00904215|143413425|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
71945164|NCT00904215|143413426|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Student Paired t-test|||||||<0.0001
71945165|NCT02576938|143413430|SUPERIORITY||||||=|0.065|||||||Chi-squared|||||||=0.065
71945166|NCT02576938|143413430|SUPERIORITY||||||=|0.027|||||||Chi-squared|||||||=0.027
71822895|NCT02478359|143149200|SUPERIORITY||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||||1.28|0.66|0.63
71945167|NCT00838630|143413441|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.27||||||90.0|92.32|104.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.61|92.32|
71945168|NCT00838630|143413442|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed for log-transformed AUC0-t, AUC0-inf, and Cmax parameters.|Geometric Test/Ref Ratio x 100|94.37||||||90.0|90.47|98.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.43|90.47|
71945169|NCT00838630|143413443|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.7||||||90.0|91.52|100.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.08|91.52|
71945170|NCT03285594|143413444|SUPERIORITY||Difference in Least Square (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.638|-0.271|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.271|-0.638|<0.0001
71945171|NCT03285594|143413444|SUPERIORITY||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.706|-0.387|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||-0.387|-0.706|<0.0001
71945172|NCT03285594|143413445|SUPERIORITY||Difference in LS Means|-15.858|STANDARD_ERROR_OF_MEAN|4.6056||0.0006|TWO_SIDED|95.0|-24.8845|-6.8309|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-6.8309|-24.8845|0.0006
71701093|NCT02469233|142918215|SUPERIORITY||Time by treatment interaction coeff.|-1.52||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.28
71945173|NCT03285594|143413445|SUPERIORITY||Difference in LS Means|-21.832|STANDARD_ERROR_OF_MEAN|4.0514|<|0.0001|TWO_SIDED|95.0|-29.7725|-13.8911|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline FPG as a covariate.||-13.8911|-29.7725|<0.0001
71822896|NCT02478359|143149201|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||||1.35|0.68|0.80
71945174|NCT03285594|143413446|SUPERIORITY||Difference in LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.716|-0.462|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-0.462|-1.716|0.0007
71945175|NCT03285594|143413446|SUPERIORITY||Difference in LS Means|-1.73|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-2.274|-1.183|||ANCOVA|||The change from baseline to Week 18 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||-1.183|-2.274|<0.0001
71945176|NCT03285594|143413447|SUPERIORITY||Difference in LS Means|-3.91|STANDARD_ERROR_OF_MEAN|1.904||0.04|TWO_SIDED|95.0|-7.642|-0.178|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.178|-7.642|0.04
71945177|NCT03285594|143413447|SUPERIORITY||Difference in LS Means|-3.83|STANDARD_ERROR_OF_MEAN|1.697||0.0239|TWO_SIDED|95.0|-7.161|-0.507|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-0.507|-7.161|0.0239
71945178|NCT03285594|143413448|SUPERIORITY||Difference in LS Means|-4.94|STANDARD_ERROR_OF_MEAN|1.425|||TWO_SIDED|95.0|-7.73|-2.142||||||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-2.142|-7.73|
71945179|NCT03285594|143413448|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|1.246||0.0018|TWO_SIDED|95.0|-6.333|-1.448|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline SBP as a covariate.||-1.448|-6.333|0.0018
71945180|NCT03285594|143413449|SUPERIORITY||Difference in LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.34||0.1265|TWO_SIDED|95.0|-1.185|0.147|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.147|-1.185|0.1265
71945181|NCT03285594|143413449|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.32||0.074|TWO_SIDED|95.0|-1.199|0.055|||ANCOVA|||The change from baseline to Week 52 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline HbA1c as a covariate.||0.055|-1.199|0.074
71945182|NCT03285594|143413450|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.868||0.2466|TWO_SIDED|95.0|-2.707|0.696|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.696|-2.707|0.2466
71945183|NCT03285594|143413450|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.672||0.332|TWO_SIDED|95.0|-1.969|0.665|||ANCOVA|||The change from baseline to Week 18 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at Week -1, randomization strata of mean SBP (\<130, ≥130 mmHg) at Week -1, randomization strata of sulfonylureas use (yes, no) at Week -1, and country as fixed effects, and baseline body weight as a covariate.||0.665|-1.969|0.332
71945184|NCT00838279|143413488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.31||||||90.0|97.82|102.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.85|97.82|
71945185|NCT00838279|143413489|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.78||||||90.0|99.09|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|99.09|
71822897|NCT02478359|143149202|SUPERIORITY|||||||0.06||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.06
71945186|NCT00838279|143413490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.94||||||90.0|97.4|102.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.55|97.40|
71945187|NCT00840411|143413515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.0||||||90.0|93.3|107.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.1|93.3|
71945188|NCT00840411|143413516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|86.5||||||90.0|80.1|93.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.4|80.1|
71945189|NCT00840411|143413517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|87.2||||||90.0|81.0|93.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||93.8|81.0|
71945190|NCT01985308|143413518|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71945191|NCT01854047|143413533|SUPERIORITY||Least Square (LS) Mean Difference|0.21||||0.0063|TWO_SIDED|95.0|0.06|0.36||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.||0.36|0.06|0.0063
71945192|NCT01854047|143413533|SUPERIORITY||LS Mean Difference|0.26||||0.0008|TWO_SIDED|95.0|0.11|0.4||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.40|0.11|0.0008
71945193|NCT01854047|143413533|SUPERIORITY||LS Mean Difference|0.17||||0.0212|TWO_SIDED|95.0|0.03|0.32||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.32|0.03|0.0212
71945194|NCT01854047|143413533|SUPERIORITY||LS Mean Difference|0.08||||0.2774|TWO_SIDED|95.0|-0.07|0.23||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.23|-0.07|0.2774
71945195|NCT01854047|143413534|SUPERIORITY||LS Mean Difference|0.16||||0.0002|TWO_SIDED|95.0|0.08|0.25||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.||0.25|0.08|0.0002
71945196|NCT01854047|143413534|SUPERIORITY||LS Mean Difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.011|0.28||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w|||0.28|0.011|<0.0001
71945197|NCT01854047|143413534|SUPERIORITY||LS Mean Difference|0.12||||0.0048|TWO_SIDED|95.0|0.04|0.21||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w|||0.21|0.04|0.0048
71945198|NCT01854047|143413534|SUPERIORITY||LS Mean Difference|0.1||||0.0304|TWO_SIDED|95.0|0.01|0.18||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w|||0.18|0.01|0.0304
71945199|NCT03273153|143413558|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2954|TWO_SIDED|95.0|0.88|1.5|||Regression, Cox|||||1.50|0.88|0.2954
71945200|NCT05323396|143413575|OTHER|||||||0.19|||||||Student's unpaired t-test|||||||0.19
71945201|NCT05323396|143413576|OTHER|||||||0.85|||||||Student's unpaired t-test|||||||0.85
71945202|NCT05323396|143413577|OTHER|||||||0.77|||||||Student's unpaired t-test|||||||0.77
71945203|NCT05323396|143413578|OTHER|||||||0.12|||||||student's unpaired t-test|||||||0.12
71945204|NCT05323396|143413579|OTHER|||||||0.81|||||||student's unpaired t-test|||||||0.81
71945205|NCT05323396|143413580|OTHER|||||||0.65|||||||student's unpaired t-test|||||||0.65
71945206|NCT01597245|143413611|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71701094|NCT02469233|142918216|SUPERIORITY||time by treatment interaction coeff.|-5.88||||0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.001
71701095|NCT02469233|142918216|SUPERIORITY||maximum likelihood estimation|-3.9||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.03
71945207|NCT01597245|143413611|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945208|NCT01597245|143413611|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945209|NCT01597245|143413612|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945210|NCT01597245|143413612|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945211|NCT01597245|143413612|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945212|NCT01597245|143413613|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.005
71945213|NCT01597245|143413613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945214|NCT01597245|143413613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945215|NCT01597245|143413614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945216|NCT01597245|143413614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945217|NCT01597245|143413614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945218|NCT01597245|143413615|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.008
71945219|NCT01597245|143413615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945220|NCT01597245|143413615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945221|NCT01597245|143413616|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71945222|NCT01597245|143413616|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71945223|NCT01597245|143413617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945224|NCT01597245|143413617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945225|NCT01597245|143413617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71945226|NCT01597245|143413618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945227|NCT01597245|143413618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945228|NCT01597245|143413618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945229|NCT01597245|143413619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
71945230|NCT01597245|143413619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945231|NCT01597245|143413619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945232|NCT01597245|143413620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945233|NCT01597245|143413620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945234|NCT01597245|143413620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945235|NCT01597245|143413621|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945236|NCT01597245|143413621|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945237|NCT01597245|143413621|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945238|NCT01597245|143413622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED||||||ANCOVA|||||||0.150
71945239|NCT01597245|143413622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71945240|NCT01597245|143413622|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71945241|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.026
71945242|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.076
71945243|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|TWO_SIDED||||||ANCOVA|||Absenteeism Score||||0.016
71945244|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
71945245|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
71945246|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Score||||<0.001
71945247|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
71945248|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
71945249|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Presenteeism Score||||<0.001
71945250|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
71822898|NCT02478359|143149203|SUPERIORITY|||||||0.07||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.07
71884564|NCT00691483|143289101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.45|||<|0.0001|TWO_SIDED|95.0|2.62|7.55||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide \>=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 \[Weeks 9-12\] and 0.18 \[Weeks 9-24\] and Varenicline CA rates of 0.46 \[Weeks 9-12\] and 0.31 \[Weeks 9-24\]) (odds ratio of \>=2.67 \[Weeks 9-12\] and \>=2.10 \[Weeks 9-24\]).||7.55|2.62|<0.0001
71945251|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
71945252|NCT01597245|143413623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Score||||<0.001
71945253|NCT01597245|143413624|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
71945254|NCT01597245|143413624|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
71945255|NCT01597245|143413624|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Physical Summary Score||||<0.001
71945256|NCT01597245|143413624|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
71945257|NCT01597245|143413624|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
71945258|NCT01597245|143413624|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Mental Summary Score||||<0.001
71945259|NCT01597245|143413625|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945260|NCT01597245|143413625|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945261|NCT01597245|143413625|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71945262|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
71822899|NCT02478359|143149204|SUPERIORITY|||||||0.67||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.67
71822900|NCT02478359|143149205|SUPERIORITY|||||||0.13||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.13
71945263|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
71945264|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 50||||<0.001
71945265|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
71945266|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
71945267|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 75||||<0.001
71945268|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||0.002
71945269|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
71945270|NCT01597245|143413626|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||PPASI 100||||<0.001
71945271|NCT00731783|143413628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||1|TWO_SIDED|95.0|0.54|1.97|||Fisher Exact|||||1.97|0.54|1.00
71945272|NCT00731783|143413629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.05|TWO_SIDED|95.0|1.03|4.55|||Fisher Exact|||||4.55|1.03|0.05
71945273|NCT00731783|143413630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.39|1.52|||Fisher Exact|||||1.52|0.39|0.49
71945274|NCT00731783|143413631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.28|TWO_SIDED|95.0|0.77|3.28|||Fisher Exact|||||3.28|0.77|0.28
71945275|NCT00731783|143413632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.12|TWO_SIDED|95.0|0.23|1.16|||Fisher Exact|||||1.16|0.23|0.12
71945276|NCT00731783|143413633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.02|TWO_SIDED|95.0|0.21|0.85|||Fisher Exact|||||0.85|0.21|0.02
71945277|NCT00731783|143413634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.2|0.77|||Fisher Exact|||||0.77|0.20|0.008
71945278|NCT00731783|143413635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.02|TWO_SIDED|95.0|0.22|0.86|||Fisher Exact|||||0.86|0.22|0.02
71945279|NCT00467896|143413652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.8|||<|0.0001|TWO_SIDED|95.0|39.55|60.15|||t-test, 2 sided|||Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)||60.15|39.55|<0.0001
71945280|NCT03772522|143413653|SUPERIORITY||Cohen's d (effect size)|0.384||||0.428|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.428
71945281|NCT03772522|143413653|SUPERIORITY||Cohen's d (effect size)|-0.46||||0.058|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and immediately post-intervention.||||0.058
71945282|NCT03772522|143413653|SUPERIORITY||Cohen's d (effect size)|-0.4||||0.095|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.||||0.095
71945283|NCT03772522|143413653|SUPERIORITY||Cohen's d (effect size)|-0.73||||0.005|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.||||0.005
71945284|NCT03772522|143413653|SUPERIORITY||Cohen's d (effect size)|-0.6||||0.022|TWO_SIDED||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.||||0.022
71945285|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|1.792||||0.002|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.||||0.002
71945286|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.047||||0.923|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.||||0.923
71945287|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.6||||0.18|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.18
71945288|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.2||||0.388|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.||||0.388
71945289|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.52||||0.037|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.037
71945290|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.09||||0.688|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.||||0.688
71945291|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.51||||0.038|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.038
71945292|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.01||||0.956|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.||||0.956
71945293|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|0.32||||0.197|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.197
71945294|NCT03772522|143413654|SUPERIORITY||Cohen's d (effect size)|-0.07||||0.762|TWO_SIDED||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.||||0.762
71945295|NCT03772522|143413655|SUPERIORITY||Cohen's d (effect size)|0.101||||0.834|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.834
71822901|NCT02478359|143149206|SUPERIORITY|||||||0.34||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.34
71945296|NCT03772522|143413655|SUPERIORITY||Cohen's d (effect size)|0.19||||0.417|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.||||0.417
71945297|NCT03772522|143413655|SUPERIORITY||Cohen's d (effect size)|0.42||||0.087|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.087
71945298|NCT03772522|143413655|SUPERIORITY||Cohen's d (effect size)|0.33||||0.168|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.168
71945299|NCT03772522|143413655|SUPERIORITY||Cohen's d (effect size)|0.37||||0.133|TWO_SIDED||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.133
71945300|NCT03772522|143413656|SUPERIORITY||Cohen's d (effect size)|1.161||||0.026|TWO_SIDED||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).||||0.026
71945301|NCT03772522|143413656|SUPERIORITY||Cohen's d (effect size)|0.62||||0.014|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.||||0.014
71945302|NCT03772522|143413656|SUPERIORITY||Cohen's d (effect size)|0.29||||0.217|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.||||0.217
71945303|NCT03772522|143413656|SUPERIORITY||Cohen's d (effect size)|0.71||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.||||0.006
71945304|NCT03772522|143413656|SUPERIORITY||Cohen's d (effect size)|0.53||||0.039|TWO_SIDED||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.||||0.039
71945305|NCT03697109|143413665|EQUIVALENCE|Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).|Odds Ratio (OR)|0.17||||0.0215|TWO_SIDED|95.0|0.04|0.77|||Chi-squared||An odds ratio (OR) \<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.|A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.||0.77|0.04|0.0215
71945306|NCT03612960|143413683|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.14|0.43|||t-test, 2 sided||||The mean percent change in BOLD signal used for this t-test was extracted from a brain cluster with significant group differences in changes in activation over time (voxel p\<.05, cluster p\<.05) identified using a whole-brain, voxel-wise two-way mixed effect ANOVA with FSL software.|0.43|0.14|<.001
71945307|NCT03612960|143413684|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|4.33||0.063|TWO_SIDED|95.0|-17.24|0.48|||t-test, 2 sided|||||0.48|-17.24|.063
71945308|NCT03612960|143413685|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|9.86||0.89|TWO_SIDED|95.0|-21.57|18.82|||t-test, 2 sided|||||18.82|-21.57|0.890
71945309|NCT01415232|143413696|NON_INFERIORITY_OR_EQUIVALENCE|Balki et al found a Pearson's correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled.|correlation coefficient|0.91|||<|0.05|TWO_SIDED|95.0|0.87|0.93|||longitudinal correlation coefficient|||Pearson's correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.||0.93|0.87|< 0.05
71945310|NCT01415232|143413696|NON_INFERIORITY_OR_EQUIVALENCE|correlation coefficient|transverse plane correlation coefficient|0.9|||>|0.85|TWO_SIDED|95.0|0.87|0.93|||transverse plane correlation coefficient|||Transverse plane correlation coefficient||0.93|0.87|>0.85
71945311|NCT01415232|143413696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.64|STANDARD_DEVIATION|1.0|>|0.05|TWO_SIDED|95.0|6.5|6.8|||t-test, 2 sided|||Clinical epidural needle depth||6.8|6.5|>0.05
71945312|NCT01415232|143413696|SUPERIORITY_OR_OTHER||Formula calculation|6.54|STANDARD_DEVIATION|0.68|>|0.05|TWO_SIDED|95.0|6.44|6.65|||Formula calculation||Estimated epidural depth equation depth (cm)|Estimated epidural depth equation depth (cm)||6.65|6.44|>0.05
71945313|NCT00272779|143413702|SUPERIORITY_OR_OTHER||Difference Estimate|1.7|||||TWO_SIDED|95.0|-3.8|7.1||Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||7.1|-3.8|
71945314|NCT00272779|143413703|SUPERIORITY_OR_OTHER||Difference Estimate|3.3|||||TWO_SIDED|95.0|-1.5|8.1|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||8.1|-1.5|
71822902|NCT02478359|143149207|SUPERIORITY|||||||0.11||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.11
71822903|NCT02478359|143149208|SUPERIORITY|||||||0.83||||||Adjusted P value|Regression, Linear|||Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site||||0.83
71884565|NCT00691483|143289102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|2.96|8.13||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.13|2.96|<0.0001
71890472|NCT00348140|143302397|SUPERIORITY||Mean Difference (Net)|0.3||||0.149|TWO_SIDED|95.0|-0.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48||0.8|-0.1|0.149
71890473|NCT01032629|143302398|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.4576|TWO_SIDED|95.0|0.78|1.12|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.12|0.78|=0.4576
71890474|NCT01032629|143302398|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0467|TWO_SIDED|95.0|0.68|1.0|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.68|=0.0467
71890475|NCT01032629|143302398|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.112|TWO_SIDED|95.0|0.75|1.03|||Cox proportional hazard method|||Comparison for canagliflozin versus placebo is reported here.||1.03|0.75|0.1120
71890476|NCT01032629|143302399|SUPERIORITY||Difference of Least Square Mean|2.79|STANDARD_ERROR_OF_MEAN|2.224|=|0.21|TWO_SIDED|95.0|-1.571|7.154|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||7.154|-1.571|=0.210
71890477|NCT01032629|143302399|SUPERIORITY||Difference of Least Square Mean|4.07|STANDARD_ERROR_OF_MEAN|2.261|=|0.072|TWO_SIDED|95.0|-0.368|8.504|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.||8.504|-0.368|=0.072
71890478|NCT01032629|143302400|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.67|0.97|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.97|0.67|
71890479|NCT01032629|143302400|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.58|0.85|||Regression, Logistic|||Comparison for canagliflozin versus placebo is reported here.||0.85|0.58|
71890480|NCT01032629|143302401|OTHER||Difference of Least Square Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|95.0|-0.429|0.374||||||Comparison for canagliflozin versus placebo is reported here.||0.374|-0.429|
71890481|NCT01032629|143302401|OTHER||Difference of Least Square Mean|0.33|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|95.0|-0.079|0.731||||||Comparison for canagliflozin versus placebo is reported here.||0.731|-0.079|
71890482|NCT01032629|143302402|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.8|0.94||||||Comparison for canagliflozin versus placebo is reported here.||0.940|0.800|
71890483|NCT01032629|143302402|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.77|0.91||||||Comparison for canagliflozin versus placebo is reported here.||0.910|0.770|
71701096|NCT02469233|142918217|SUPERIORITY||time by treatment interaction coeff.|-5.55|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
71945315|NCT00272779|143413706|SUPERIORITY_OR_OTHER||Difference Estimate|-16.4|||||TWO_SIDED|95.0|-35.9|3.1|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||3.1|-35.9|
71945316|NCT00272779|143413728|SUPERIORITY_OR_OTHER||Difference Estimate|6.1|||||TWO_SIDED|95.0|0.3|12.0||Assuming 70% response rate (70% of participants remain on treatment for 96 wks and HIV RNA \<50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV|Cochran-Mantel-Haenszel|The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions \> -10%.||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir- lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization-HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting||12.0|0.3|
71945317|NCT00272779|143413729|SUPERIORITY_OR_OTHER||Difference Estimate|5.1|||||TWO_SIDED|95.0|-0.4|10.6|||Cochran-Mantel-Haenszel|||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV-LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization-ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).||10.6|-0.4|
71945318|NCT00272779|143413731|SUPERIORITY_OR_OTHER||Difference Estimate|-21.2|||||TWO_SIDED|95.0|-43.3|0.9|||95% CI comparison of difference|||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.||0.9|-43.3|
71945319|NCT00272779|143413747|SUPERIORITY_OR_OTHER||point estimate|0.761|||||TWO_SIDED|90.0|0.507|1.142|||ANOVA||Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.142|0.507|
71945320|NCT00272779|143413748|SUPERIORITY_OR_OTHER||point estimate|1.46|||||TWO_SIDED|90.0|1.005|2.121|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||2.121|1.005|
71945321|NCT00272779|143413749|SUPERIORITY_OR_OTHER||point estimate|0.839|||||TWO_SIDED|90.0|0.612|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.612|
71945322|NCT00272779|143413750|SUPERIORITY_OR_OTHER||point estimate|0.282|||||TWO_SIDED|90.0|0.181|0.439|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||0.439|0.181|
71945323|NCT00272779|143413751|SUPERIORITY_OR_OTHER||point estimate|0.925|||||TWO_SIDED|90.0|0.699|1.223|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.223|0.699|
71945324|NCT00272779|143413752|SUPERIORITY_OR_OTHER||point estimate|0.853|||||TWO_SIDED|90.0|0.626|1.161|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.161|0.626|
71945325|NCT00272779|143413753|SUPERIORITY_OR_OTHER||point estimate|0.89|||||TWO_SIDED|90.0|0.689|1.151|||ANOVA||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.|||1.151|0.689|
71945326|NCT00272779|143413777|SUPERIORITY_OR_OTHER|||||||0.0847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0847
71945327|NCT00272779|143413778|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.0058
71822904|NCT02240680|143149212|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.81|-0.46|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-0.46|-0.81|< 0.0001
71890484|NCT01032629|143302403|OTHER||Difference of Least Square Mean|1.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|0.599|2.755||||||Comparison for canagliflozin versus placebo is reported here.||2.755|0.599|
71822905|NCT02240680|143149213|OTHER||Odds Ratio (OR)|1.464|STANDARD_ERROR_OF_MEAN|0.397||0.1594|TWO_SIDED|95.0|0.861|2.491|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For any hypoglycemia event accompanied by prespecified glucose value||2.491|0.861|0.1594
71822906|NCT02240680|143149213|OTHER||Odds Ratio (OR)|1.149|STANDARD_ERROR_OF_MEAN|0.377||0.672|TWO_SIDED|95.0|0.604|2.188|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For glucose value \< 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia||2.188|0.604|0.6720
71701097|NCT02469233|142918217|SUPERIORITY||Time by treatment interaction coeff.|-4.92|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||<0.0001
71890485|NCT01032629|143302403|OTHER||Difference of Least Square Mean|1.24|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|95.0|0.16|2.328||||||Comparison for canagliflozin versus placebo is reported here.||2.328|0.160|
71701098|NCT02469233|142918218|SUPERIORITY||Time by treatment interaction coeff.|-9.14|||<|0.0001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||<0.0001
71822907|NCT02240680|143149214|OTHER||Odds Ratio (OR)|5.018|STANDARD_ERROR_OF_MEAN|1.818|<|0.0001|TWO_SIDED|95.0|2.468|10.206|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||10.206|2.468|< 0.0001
71822908|NCT02240680|143149215|OTHER||Odds Ratio (OR)|4.689|STANDARD_ERROR_OF_MEAN|1.519|<|0.0001|TWO_SIDED|95.0|2.485|8.848|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||8.848|2.485|< 0.0001
71822909|NCT02240680|143149216|OTHER||Odds Ratio (OR)|3.731|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|2.302|6.048|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio|||6.048|2.302|< 0.0001
71822910|NCT02240680|143149217|SUPERIORITY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|4.8||0.0178|TWO_SIDED|95.0|-21.0|-2.0|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|-2.0|-21.0|0.0178
71822911|NCT00755755|143149218|SUPERIORITY_OR_OTHER||Difference in proportions|72.7|||<|0.001|TWO_SIDED|95.0|55.1|83.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||83.2|55.1|<0.001
71822912|NCT00755755|143149218|SUPERIORITY_OR_OTHER||Difference in proportions|73.7|||<|0.001|TWO_SIDED|95.0|56.2|84.0||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)|||84.0|56.2|<0.001
71822913|NCT00755755|143149219|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-22.6||||0.002|TWO_SIDED|95.0|-36.1|-8.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-8.2|-36.1|0.002
71822914|NCT00755755|143149219|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.2||||0.006|TWO_SIDED|95.0|-33.0|-5.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.|||-5.2|-33.0|0.006
71822915|NCT00083174|143149223|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35||||0.002|TWO_SIDED|95.0|0.18|0.7|||Log Rank|||The null hypothesis was no difference between two groups. The sample size estimate was based on an assumption of annual invasive breast cancer rate of 0.60% in the placebo group and 0.21% in exemestane group, a relative reduction of 65% with exemestane. To detect this with a two-sided 5% level and 90% power, a total of 38 cases of invasive breast cancer were required, projected to occur when 4560 women were randomly assigned in a 3-year period and then followed for an additional 1.2 years.||0.70|0.18|0.002
71822916|NCT00083174|143149224|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.27|0.79|||Log Rank|||||0.79|0.27|0.004
71822917|NCT00083174|143149225|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.36||||0.07|TWO_SIDED|95.0|0.11|1.12|||Log Rank|||||1.12|0.11|0.07
71822918|NCT00483262|143149230|SUPERIORITY_OR_OTHER||>= grade 3 adverse event proportion|0.9|||||TWO_SIDED|90.0|0.72|0.98|||||Estimated proportion of patients with a adverse event of grade 3 or higher.|Single Arm Study||.98|.72|
71822919|NCT00483262|143149230|SUPERIORITY_OR_OTHER||toxicity grade >=3 proportion|0.79|||||TWO_SIDED|90.0|0.66|0.89|||||No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.|Phase II toxicity||.89|.66|
71822920|NCT00483262|143149231|SUPERIORITY_OR_OTHER||response rate of PR or better|0.1|||||TWO_SIDED|90.0|0.02|0.28|||||Response of PR or better|Phase I part of this phase I/II study||.28|.02|
71822921|NCT00483262|143149231|SUPERIORITY_OR_OTHER||response rate of PR or better|0.33|||||TWO_SIDED|90.0|0.21|0.47|||||Response of PR or better|Phase II part of this phase I/II study.||0.47|0.21|
71822922|NCT01027871|143149244|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.17||||0.433|TWO_SIDED|90.0|-0.18|0.52||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.52|-0.18|0.433
71822923|NCT01027871|143149245|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.2||||0.388|TWO_SIDED|90.0|-0.59|0.19||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.59|0.388
71822924|NCT01027871|143149246|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.09||||0.197|TWO_SIDED|90.0|-0.21|0.03||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.03|-0.21|0.197
71822925|NCT01027871|143149247|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%"|Fisher Exact|||||||0.609
71822926|NCT01027871|143149247|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.314
71822927|NCT01027871|143149248|SUPERIORITY_OR_OTHER|||||||0.375||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.375
71822928|NCT01027871|143149248|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||"The statistical significance level is 0.10.~P- value is for HbA1c ≤6.5%"|Fisher Exact|||||||0.811
71822929|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.43||||0.144|TWO_SIDED|90.0|-0.92|0.05||"The statistical significance level is 0.10.~P- value is for morning 2-hr postprandial BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.92|0.144
71890486|NCT01032629|143302404|OTHER||Difference of Least Square Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.045|||TWO_SIDED|95.0|-0.355|-0.177||||||Comparison for canagliflozin versus placebo is reported here.||-0.177|-0.355|
71822930|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.36|TWO_SIDED|90.0|-0.7|0.2||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.20|-0.70|0.360
71822931|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.342|TWO_SIDED|90.0|-0.72|0.19||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.72|0.342
71822932|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.12||||0.654|TWO_SIDED|90.0|-0.56|0.32||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.56|0.654
71822933|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.25||||0.387|TWO_SIDED|90.0|-0.73|0.23||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.23|-0.73|0.387
71822934|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.339|TWO_SIDED|90.0|-0.79|0.21||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.21|-0.79|0.339
71822935|NCT01027871|143149249|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.1||||0.676|TWO_SIDED|90.0|-0.3|0.5||"The statistical significance level is 0.10.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.50|-0.30|0.676
71822936|NCT01027871|143149251|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||The statistical significance level is 0.10.|Fisher Exact|||||||0.162
71822937|NCT01027871|143149252|SUPERIORITY_OR_OTHER|||||||0.804||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.804
71822938|NCT01027871|143149254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.937||90.0|-0.16|0.14||"The statistical significance level is 0.10.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.14|-0.16|0.937
71822939|NCT01027871|143149254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.03||||0.687|TWO_SIDED|90.0|-0.16|0.1||"The statistical significance level is 0.10.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.10|-0.16|0.687
71822940|NCT01027871|143149256|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.159|TWO_SIDED|90.0|-0.87|0.07||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-0.87|0.159
71822941|NCT01027871|143149256|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.542|TWO_SIDED|90.0|-0.62|0.29||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.29|-0.62|0.542
71822942|NCT01027871|143149257|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.88|TWO_SIDED|90.0|-0.16|0.13||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.16|0.880
71822943|NCT01027871|143149257|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.17||||0.045|TWO_SIDED|90.0|-0.32|-0.03||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.03|-0.32|0.045
71822944|NCT01027871|143149258|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.273
71822945|NCT01027871|143149258|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.287
71822946|NCT01027871|143149258|SUPERIORITY_OR_OTHER|||||||0.879||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.879
71822947|NCT01027871|143149258|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.722
71822948|NCT01027871|143149259|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.139
71822949|NCT01027871|143149259|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.569
71822950|NCT01027871|143149259|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.515
71822951|NCT01027871|143149259|SUPERIORITY_OR_OTHER|||||||1||95.0||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||1.000
71822952|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.26||||0.305|TWO_SIDED|90.0|-0.16|0.67||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.67|-0.16|0.305
71890487|NCT01032629|143302404|OTHER||Difference of Least Square Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.405|-0.227||||||Comparison for canagliflozin versus placebo is reported here.||-0.227|-0.405|
71822953|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.14||||0.571|TWO_SIDED|90.0|-0.54|0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.26|-0.54|0.571
71822954|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.26||||0.454||90.0|-0.85|0.32||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.32|-0.85|0.454
71822955|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.83||||0.016|TWO_SIDED|90.0|-1.4|-0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.26|-1.40|0.016
71822956|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.07||||0.838||90.0|-0.61|0.48||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.48|-0.61|0.838
71822957|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.69||||0.033|TWO_SIDED|90.0|-1.22|-0.16||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.16|-1.22|0.033
71822958|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.4||||0.229|TWO_SIDED|90.0|-0.95|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.95|0.229
71822959|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.27||||0.412|TWO_SIDED|90.0|-0.8|0.27||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.27|-0.80|0.412
71822960|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.15||||0.642|TWO_SIDED|90.0|-0.68|0.38||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.38|-0.68|0.642
71822961|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.16||||0.614|TWO_SIDED|90.0|-0.67|0.36||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.36|-0.67|0.614
71822962|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.5||||0.147|TWO_SIDED|90.0|-1.07|0.07||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.07|-1.07|0.147
71822963|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.42||||0.21|TWO_SIDED|90.0|-0.98|0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.13|-0.98|0.210
71822964|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.28||||0.438|TWO_SIDED|90.0|-0.86|0.31||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.31|-0.86|0.438
71822965|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.7||||0.043|TWO_SIDED|90.0|-1.28|-0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||-0.13|-1.28|0.043
71822966|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.24||||0.403|TWO_SIDED|90.0|-0.23|0.72||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.72|-0.23|0.403
71822967|NCT01027871|143149260|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.29||||0.314|TWO_SIDED|90.0|-0.75|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.75|0.314
71822968|NCT01027871|143149262|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.046
71884566|NCT00691483|143289103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|3.66|8.75||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 12. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||8.75|3.66|<0.0001
71884567|NCT00691483|143289103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.58|6.58||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 24. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.58|2.58|<0.0001
71822969|NCT01027871|143149262|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact|||||||0.224
71822970|NCT01027871|143149263|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.561
71822971|NCT01027871|143149263|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model|||||||0.518
71822972|NCT01027871|143149264|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.938|TWO_SIDED|90.0|-0.2|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.18|-0.20|0.938
71822973|NCT01027871|143149264|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.0||||0.972|TWO_SIDED|90.0|-0.18|0.19||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.19|-0.18|0.972
71822974|NCT01027871|143149264|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.01||||0.927|TWO_SIDED|90.0|-0.16|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.15|-0.16|0.927
71822975|NCT01027871|143149264|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.1||||0.293|TWO_SIDED|90.0|-0.25|0.05||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 - Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.|||0.05|-0.25|0.293
71822976|NCT02084082|143149293|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|100.37|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|96.562|104.326|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.326|96.562|<0.0001
71822977|NCT02084082|143149293|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio (net)|94.7|STANDARD_ERROR_OF_MEAN|1.037||0.0004|TWO_SIDED|90.0|88.712|101.089|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000 Fed/ L+M 1000 Fed)|||101.089|88.712|0.0004
71822978|NCT02084082|143149294|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|108.09|STANDARD_ERROR_OF_MEAN|1.054||0.0038|TWO_SIDED|90.0|99.022|117.989|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||117.989|99.022|0.0038
71822979|NCT02084082|143149294|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.24|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.067|102.597|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||102.597|94.067|<0.0001
71822980|NCT02084082|143149295|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|99.99|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|93.03|107.47|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.47|93.03|<0.0001
71822981|NCT02084082|143149295|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.95|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|92.24|101.89|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||101.89|92.24|<0.0001
71822982|NCT02084082|143149296|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.77|STANDARD_ERROR_OF_MEAN|1.046|<|0.0001|TWO_SIDED|90.0|92.464|107.645|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||107.645|92.464|<0.0001
71822983|NCT02084082|143149296|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.97|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.95|103.16|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.160|94.950|<0.0001
71890488|NCT01032629|143302405|OTHER||Difference of Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|-0.794|-0.374||||||Comparison for canagliflozin versus placebo is reported here.||-0.374|-0.794|
71890489|NCT01032629|143302405|OTHER||Difference of Least Square Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.945|-0.523||||||Comparison for canagliflozin versus placebo is reported here.||-0.523|-0.945|
71822984|NCT02084082|143149297|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.72|STANDARD_ERROR_OF_MEAN|1.028|<|0.0001|TWO_SIDED|90.0|95.163|104.493|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||104.493|95.163|<0.0001
71822985|NCT02084082|143149297|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.36|STANDARD_ERROR_OF_MEAN|1.132||0.0778|TWO_SIDED|90.0|77.082|122.963|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||122.963|77.082|0.0778
71822986|NCT02084082|143149298|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.11|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.37|106.35|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fasted/ L+M 1000 fasted)|||106.35|92.37|<0.0001
71822987|NCT02084082|143149298|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|93.34|103.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1000\_fed / L+M 1000 fed)|||103.27|93.34|<0.0001
71822988|NCT04736056|143149311|OTHER||Cohen's d effect size|1.2|||||TWO_SIDED|95.0|0.73|1.66||||||0 to 12 weeks||1.66|0.73|
71822989|NCT04736056|143149311|OTHER||Cohen's d effect size|1.07|||||TWO_SIDED|95.0|0.61|1.51||||||0 to 16 weeks||1.51|0.61|
71822990|NCT04736056|143149312|OTHER||Cohen's d effect size|0.35|||||TWO_SIDED|95.0|-0.02|0.71||||||0 to 12 weeks||0.71|-0.02|
71822991|NCT04736056|143149312|OTHER||Cohen's d effect size|0.25|||||TWO_SIDED|95.0|-0.12|0.61||||||0 to 16 weeks||0.61|-0.12|
71822992|NCT04736056|143149313|OTHER||Cohen's d effect size|0.78|||||TWO_SIDED|95.0|0.38|1.18||||||0 to 12 weeks||1.18|0.38|
71822993|NCT04736056|143149313|OTHER||Cohen's d effect size|0.5|||||TWO_SIDED|95.0|0.11|0.87||||||0 to 16 weeks||0.87|0.11|
71822994|NCT04736056|143149314|OTHER||Cohen's d effect size|0.23|||||TWO_SIDED|95.0|-0.13|0.58||||||0 to 12 weeks||0.58|-0.13|
71822995|NCT04736056|143149314|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.05|0.68||||||0 to 16 weeks||0.68|-0.05|
71822996|NCT04736056|143149315|OTHER||Cohen's d effect size|0.32|||||TWO_SIDED|95.0|-0.04|0.68||||||0 to 12 weeks||0.68|-0.04|
71822997|NCT04736056|143149315|OTHER||Cohen's d effect size|0.61|||||TWO_SIDED|95.0|0.22|1.0||||||0 to 16 weeks||1.00|0.22|
71822998|NCT04736056|143149316|OTHER||Cohen's d effect size|0.38|||||TWO_SIDED|95.0|0.01|0.74||||||0 to 12 weeks||0.74|0.01|
71822999|NCT04736056|143149316|OTHER||Cohen's d effect size|0.47|||||TWO_SIDED|95.0|0.09|0.85||||||0 to 16 weeks||0.85|0.09|
71823000|NCT04736056|143149317|OTHER||Cohen's d effect size|0.29|||||TWO_SIDED|95.0|-0.07|0.65||||||0 to 12 weeks||0.65|-0.07|
71823001|NCT04736056|143149317|OTHER||Cohen's d effect size|0.6|||||TWO_SIDED|95.0|0.21|0.99||||||||0.99|0.21|
71823002|NCT04736056|143149318|OTHER||Cohen's d effect size|0.54|||||TWO_SIDED|95.0|0.16|0.91||||||0 to 12 weeks||0.91|0.16|
71823003|NCT04736056|143149318|OTHER||Cohen's d effect size|0.51|||||TWO_SIDED|95.0|0.12|0.89||||||0 to 16 weeks||0.89|0.12|
71823004|NCT04736056|143149319|OTHER||Cohen's d effect size|0.89|||||TWO_SIDED|95.0|0.47|1.3||||||0 to 12 weeks||1.30|0.47|
71823005|NCT04736056|143149319|OTHER||Cohen's d effect size|0.66|||||TWO_SIDED|95.0|0.26|1.05||||||0 to 16 weeks||1.05|0.26|
71823006|NCT04736056|143149320|OTHER||Cohen's d effect size|-0.4|||||TWO_SIDED|95.0|-0.76|-0.03||||||0 to 12 weeks||-0.03|-0.76|
71823007|NCT04736056|143149320|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.71|0.03||||||0 to 16 weeks||0.03|-0.71|
71823008|NCT04736056|143149321|OTHER||Cohen's d effect size|0.0|||||TWO_SIDED|95.0|-0.35|0.35||||||0 to 12 weeks||0.35|-0.35|
71823009|NCT04736056|143149321|OTHER||Cohen's d effect size|-0.28|||||TWO_SIDED|95.0|-0.64|0.09||||||0 to 16 weeks||0.09|-0.64|
71823010|NCT04736056|143149322|OTHER||Cohen's d effect size|0.1|||||TWO_SIDED|95.0|-0.45|0.26||||||||0.26|-0.45|
71823011|NCT04736056|143149322|OTHER||Cohen's d effect size|0.09|||||TWO_SIDED|95.0|-0.27|0.45||||||0 to 16 weeks||0.45|-0.27|
71823012|NCT04736056|143149323|OTHER||Cohen's d effect size|-0.035|||||TWO_SIDED|95.0|-0.71|0.01||||||0 to 12 weeks||0.01|-0.71|
71823013|NCT04736056|143149323|OTHER||Cohen's d effect size|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||0 to 16 weeks||0.08|-0.65|
71823014|NCT04736056|143149324|OTHER||Cohen's d effect size|-0.34|||||TWO_SIDED|95.0|-0.7|0.03||||||0 to 12 weeks||0.03|-0.70|
71823015|NCT04736056|143149324|OTHER||Cohen's d effect size|-0.47|||||TWO_SIDED|95.0|-0.85|-0.09||||||0 to 16 weeks||-0.09|-0.85|
71823016|NCT03437668|143149329|SUPERIORITY|To test for a differential treatment effect, we fit a linear mixed with group, time, and a group by time interaction as the predictors and random intercepts to account for the correlations induced by the repeated measurements within subjects. Given the form of the trajectories and the small sample size, we chose to treat time as continuous to minimize the number of degrees of freedom and the risk of overfitting.|Slope|-0.22||||0.31|TWO_SIDED|||||p-value is for the interaction of time and treatment group in the mixed model|Mixed Models Analysis|||||||.31
71823017|NCT00615433|143149351|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni's procedure for controlling pairwise differences.||||<0.05
71823018|NCT00615433|143149352|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
71890490|NCT01032629|143302406|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.26||||95.0|-3.472|-2.454||||||Comparison for canagliflozin versus placebo is reported here.||-2.454|-3.472|
71823019|NCT00819234|143149353|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|STANDARD_ERROR_OF_MEAN|2.863||0.0135|TWO_SIDED|95.0|-12.93|-1.54|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.||-1.54|-12.93|0.0135
71823020|NCT00819234|143149353|SUPERIORITY_OR_OTHER||LS Mean|-6.55|STANDARD_ERROR_OF_MEAN|2.681||0.0168|TWO_SIDED|95.0|-11.89|-1.21|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||-1.21|-11.89|0.0168
71823021|NCT00819234|143149353|SUPERIORITY_OR_OTHER||LS Mean|-5.52|STANDARD_ERROR_OF_MEAN|2.887||0.0595|TWO_SIDED|95.0|-11.27|0.23|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons||0.23|-11.27|0.0595
71823022|NCT05174065|143149373|SUPERIORITY||Adjusted Difference in Proportion|32.6|||<|0.0001|TWO_SIDED|95.0|18.7|46.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of rounded PPPASI total score range (≤ 20/21 to 30/≥ 31) and focal infection status (yes/no) at baseline.|Based on the Cochran-Mantel-Haenszel method adjusting for the stratification factors. The adjusted difference in proportion was the weighted average of the treatment differences across strata.|||46.5|18.7|<0.0001
71823023|NCT05174065|143149374|SUPERIORITY||Difference in Least Squares Mean|-6.13|||<|0.0001|TWO_SIDED|95.0|-8.57|-3.69|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-3.69|-8.57|<0.0001
71823024|NCT05174065|143149375|SUPERIORITY||Difference in Least Squares Mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and baseline value as covariate.|Apremilast - Placebo|||-0.9|-2.2|<0.0001
71823025|NCT05174065|143149376|SUPERIORITY||Difference in Least Squares Mean|-7.8||||0.033|TWO_SIDED|95.0|-14.9|-0.6|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.6|-14.9|0.0330
71823026|NCT05174065|143149377|SUPERIORITY||Difference in Least Squares Mean|-10.8||||0.0076|TWO_SIDED|95.0|-18.6|-2.9|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-2.9|-18.6|0.0076
71823027|NCT05174065|143149378|SUPERIORITY||Difference in Least Squares Mean|-1.4||||0.0036|TWO_SIDED|95.0|-2.4|-0.5|||MMRM|With treatment group, visit time, treatment-by-time interaction, and stratification factors as fixed effect, and the baseline value as a covariate.|Apremilast - Placebo|||-0.5|-2.4|0.0036
71823028|NCT02337361|143149405|OTHER||||||||||||||||||Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||
71823029|NCT02337361|143149405|OTHER||||||||||||||||||Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation|||
71823030|NCT02337361|143149406|OTHER||Odds Ratio (OR)|0.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.01
71823031|NCT02337361|143149407|OTHER||Odds Ratio (OR)|0.23|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up|||||<.05
71823032|NCT02337361|143149408|OTHER||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.|||<.10
71823033|NCT02337361|143149409|OTHER||Odds Ratio (OR)|0.26|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up|||||<.01
71823034|NCT02337361|143149410|OTHER||||||||||||||||||Generalized estimating equations (GEE) tested DrinkWise's effects on changes in depression over time controlling for demographic differences between study condition and study sites.|||
71823035|NCT02427646|143149412|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|||||||<0.05
71823036|NCT02427646|143149413|OTHER|"A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (lme4 package using lmer function)."|||||<|0.05|||||||Linear mixed effects model|a log-transformation ofthe RMS datasets was applied for statistical analysis||||||<0.05
71823037|NCT00901485|143149424|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To test for non-inferiority, a sample size of 36 (18 patients completing both arms of the crossover) was calculated to provide 80% power to detect a 2.5% drop in the primary outcome, mean overnight oxygen saturation (SpO2), with a SD of 3% at a significance level of 0.05|Median Difference (Final Values)|0.4||||0.13|TWO_SIDED|95.0|-0.2|1.0||a priori threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||"We tested the hypothesis that iVAPS can ventilate a patient naive to NIV at least as effectively as standard PS.~Sleep and breathing parameters at the end of each treatment period were compared using Wilcoxon Signed Rank test. The median difference between treatments with 95% confidence intervals was then compared by related-samples Hodges-Lehman test"||1.0|-0.2|0.13
71823038|NCT00901485|143149425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|PtcCO2 is compared as a secondary outcome resulting in CO2 elimination similar to that of standard PS ventilation (median difference (95% CI) of -0.04(- 0.03 to 0.4)kPa in mean overnight PtcCO2).|Median Difference (Final Values)|0.0||||0.54|TWO_SIDED|95.0|-0.3|0.4|||Wilcoxon (Mann-Whitney)|||Hypothesis: that we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non-inferior to standard pressure support (PS) ventilation, with settings determined by an experienced healthcare professional, for controlling nocturnal hypoventilation in patients naïve to NIV.||0.4|-0.3|0.54
71823039|NCT00901485|143149426|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-0.5|0.94
71823040|NCT00901485|143149427|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.42|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.42
71823041|NCT00901485|143149428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.0||||0.82||95.0|-8.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|-8|0.82
71823042|NCT00901485|143149429|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|1.04||||0.0004|TWO_SIDED|95.0|0.27|1.44|||Wilcoxon (Mann-Whitney)|||||1.44|0.27|0.0004
71823043|NCT00901485|143149430|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Mean Difference (Net)|-0.2||||0.5|TWO_SIDED|95.0|-1.2|0.5|||Wilcoxon (Mann-Whitney)|||||0.5|-1.2|0.5
71823044|NCT00901485|143149431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-2.2||||0.001|TWO_SIDED|95.0|-4.5|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-4.5|0.001
71823045|NCT00901485|143149432|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-10.0||||0.47|TWO_SIDED|95.0|-54.0|23.0|||Wilcoxon (Mann-Whitney)|||||23|-54|0.47
71823046|NCT00901485|143149433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|0.3||||0.41|TWO_SIDED|95.0|-0.7|2.2|||Wilcoxon (Mann-Whitney)|||||2.2|-0.7|0.41
71823047|NCT00901485|143149434|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|4.0||||0.36|TWO_SIDED|95.0|-5.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-5|0.36
71823048|NCT00901485|143149435|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
71823049|NCT00901485|143149436|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|2.0||||0.59|TWO_SIDED|95.0|-5.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-5|0.59
71823050|NCT00901485|143149437|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a secondary outcome|Median Difference (Net)|-1.0||||0.72|TWO_SIDED|95.0|-9.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|-9|0.72
71823051|NCT01796665|143149441|EQUIVALENCE|provides 85% power of success|Equivalence ratio|96.57|||||TWO_SIDED|90.0|92.5|105.2|||Fieller's method|||||105.2|92.5|
71823052|NCT01796665|143149442|EQUIVALENCE|provides 85% power of success|Equivalence ratio|99.96|||||TWO_SIDED|90.0|92.9|110.5|||Fieller's method|||||110.5|92.9|
71823053|NCT01796665|143149443|EQUIVALENCE|provides 85% power of success|Equivalence ratio|-1.14|||||TWO_SIDED|90.0|-13.23|-1.13|||Fieller's method|||||-1.13|-13.23|
71823054|NCT03660943|143149450|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|1.192||0.0833|TWO_SIDED|95.0|-4.42|0.27|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.27|-4.42|0.0833
71823055|NCT03660943|143149451|SUPERIORITY|The number of NPRS subjects differed from the WOMAC outcomes because of differences in missing data.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.251||0.0935|TWO_SIDED|95.0|-0.91|0.07|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.07|-0.91|0.0935
71823056|NCT03660943|143149452|SUPERIORITY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.506||0.0163|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||-0.23|-2.22|0.0163
71823057|NCT03660943|143149453|SUPERIORITY||Mean Difference (Final Values)|-7.99|STANDARD_ERROR_OF_MEAN|4.076||0.0509|TWO_SIDED|95.0|-16.01|0.03|||Mixed Models Analysis|||The MMRM analysis included the change from study baseline in scores as the dependent variable, with terms for treatment, pooled study center, study baseline K-L grade category for the index knee, study baseline BMI category, study baseline OA type (unilateral or bilateral knee OA), sex, study visit, treatment by visit interaction, and study baseline score as covariates, using an unstructured covariance structure.||0.03|-16.01|0.0509
71890491|NCT01032629|143302406|OTHER||Difference of Least Square Mean|-3.61|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|-4.125|-3.103||||||Comparison for canagliflozin versus placebo is reported here.||-3.103|-4.125|
71823058|NCT02892409|143149524|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95 percent (%) confidence interval (CI) of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|Least Square (LS) Mean Ratio|105.1|||||TWO_SIDED|95.0|66.051|167.183||||||||167.183|66.051|
71823059|NCT02892409|143149525|EQUIVALENCE|LS Mean Ratio (TAK-438/Lansoprazole), 95% CI of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|LS Mean Ratio|93.6|||||TWO_SIDED|95.0|67.137|130.569||||||||130.569|67.137|
71823060|NCT02331940|143149527|SUPERIORITY_OR_OTHER|||||||0.88||||||p\<0.05 was considered statistically significant|t-test, 1 sided|||||||0.88
71823061|NCT01345292|143149534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.44|STANDARD_ERROR_OF_MEAN|1.556|<|0.001|TWO_SIDED|95.0|8.37|14.5||If Sensodyne is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.50|8.37|<0.001
71823062|NCT01345292|143149534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|5.24|11.42||If Potassium Oxalate Mouth Rinse is better than Crest Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.42|5.24|<0.001
71823063|NCT01345292|143149535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|1.45|4.65||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.65|1.45|<0.001
71823064|NCT01345292|143149535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.818||0.004|TWO_SIDED|95.0|0.8|4.02||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.02|0.80|0.004
71823065|NCT01345292|143149536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.091||0.324|TWO_SIDED|95.0|-6.19|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.06|-6.19|0.324
71823066|NCT01345292|143149536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|2.093||0.035|TWO_SIDED|95.0|-8.56|-0.31||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.31|-8.56|0.035
71823067|NCT01345292|143149537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|STANDARD_ERROR_OF_MEAN|2.551|<|0.001|TWO_SIDED|95.0|-13.6|-3.52||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.52|-13.6|<0.001
71823068|NCT01345292|143149537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.553|<|0.001|TWO_SIDED|95.0|-15.2|-5.13||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.13|-15.2|<0.001
71823069|NCT01345292|143149538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91|STANDARD_ERROR_OF_MEAN|2.271||0.032|TWO_SIDED|95.0|-9.38|-0.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.43|-9.38|0.032
71823070|NCT01345292|143149538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.288||0.136|TWO_SIDED|95.0|-7.93|1.09||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.09|-7.93|0.136
71823071|NCT01345292|143149539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|2.508|<|0.001|TWO_SIDED|95.0|-16.1|-6.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.23|-16.1|<0.001
71823072|NCT01345292|143149539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|2.527|<|0.001|TWO_SIDED|95.0|-15.2|-5.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.25|-15.2|<0.001
71823073|NCT01345292|143149540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|2.012||0.533|TWO_SIDED|95.0|-5.22|2.71||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.71|-5.22|0.533
71823074|NCT01345292|143149540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.023||0.522|TWO_SIDED|95.0|-5.29|2.69||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.69|-5.29|0.522
71823075|NCT01345292|143149541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.331|<|0.001|TWO_SIDED|95.0|-13.1|-3.94||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.94|-13.1|<0.001
71823076|NCT01345292|143149541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.13|STANDARD_ERROR_OF_MEAN|2.344||0.01|TWO_SIDED|95.0|-10.8|-1.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.51|-10.8|0.010
71823077|NCT01033643|143149546|OTHER||Accumulation or Geometric Mean Ratio|2.36|||||||||||||Accumulation ratio or geometric mean ratio (GMR) was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
71823078|NCT01033643|143149547|OTHER||Accumulation or Geometric Mean Ratio|1.62|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
71823079|NCT01033643|143149549|OTHER||Accumulation or Geometric Mean Ratio|1.9|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
71823080|NCT01033643|143149549|OTHER||Accumulation or Geometric Mean Ratio|1.63|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
71884568|NCT00691483|143289104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|95.0|2.58|6.67||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value \>0.05 was obtained.||6.67|2.58|<0.0001
71884569|NCT01262365|143289106|SUPERIORITY||Odds Ratio (OR)|1.307|||=|0.175|TWO_SIDED|95.0|0.888|1.923|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.923|0.888|=0.175
71884570|NCT01262365|143289106|SUPERIORITY||Odds Ratio (OR)|1.164|||=|0.442|TWO_SIDED|95.0|0.79|1.714|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.||1.714|0.790|=0.442
71884571|NCT00326898|143289112|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|97.5|0.85|1.23|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.23|0.85|0.80
71884572|NCT00326898|143289112|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.72|TWO_SIDED|97.5|0.8|1.17|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.||||1.17|0.80|0.72
71884573|NCT00326898|143289113|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|97.5|0.9|1.52|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.52|0.90|
71884574|NCT00326898|143289113|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|97.5|0.75|1.28|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.|||1.28|0.75|
71884575|NCT01166230|143289153|SUPERIORITY_OR_OTHER|||||||0.141|||||||Fisher Exact|||||||0.141
71884576|NCT01166230|143289154|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.041
71884577|NCT01166230|143289155|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|99.0|||||Wilcoxon (Mann-Whitney)|||||||0.056
71884578|NCT04986202|143289214|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.537|TWO_SIDED|95.0|-3.86|2.02||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||2.02|-3.86|0.537
71884579|NCT04986202|143289214|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.221|TWO_SIDED|95.0|-4.71|1.09||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||1.09|-4.71|0.221
71884580|NCT04986202|143289215|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.559|TWO_SIDED|95.0|-5.7|10.5||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||10.5|-5.7|0.559
71884581|NCT04986202|143289215|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.195|TWO_SIDED|95.0|-2.7|13.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|||13.3|-2.7|0.195
71884582|NCT04986202|143289216|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.289|TWO_SIDED|95.0|-4.71|1.41||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.41|-4.71|0.289
71884583|NCT04986202|143289216|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.571|TWO_SIDED|95.0|-3.86|2.13||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||2.13|-3.86|0.571
71884584|NCT04986202|143289216|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.89|TWO_SIDED|95.0|-3.8|3.3||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||3.30|-3.80|0.890
71884585|NCT04986202|143289216|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.558|TWO_SIDED|95.0|-4.55|2.46||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||2.46|-4.55|0.558
71884586|NCT04986202|143289217|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.619|TWO_SIDED|95.0|-11.1|6.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||6.6|-11.1|0.619
71884587|NCT04986202|143289217|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.522|TWO_SIDED|95.0|-5.8|11.4||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||11.4|-5.8|0.522
71884588|NCT04986202|143289217|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.267|TWO_SIDED|95.0|-4.4|15.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||15.8|-4.4|0.267
71884589|NCT04986202|143289217|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.657|TWO_SIDED|95.0|-7.6|12.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||12.1|-7.6|0.657
71884590|NCT04986202|143289218|SUPERIORITY||Geometric mean ratio|0.95||||0.312|TWO_SIDED|95.0|0.86|1.05||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.05|0.86|0.312
71884591|NCT04986202|143289218|SUPERIORITY||Geometric mean ratio|0.91||||0.07|TWO_SIDED|95.0|0.83|1.01||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 16 weeks||1.01|0.83|0.070
71884592|NCT04986202|143289218|SUPERIORITY||Geometric mean ratio|1.01||||0.911|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.911
71884593|NCT04986202|143289218|SUPERIORITY||Geometric mean ratio|1.01||||0.837|TWO_SIDED|95.0|0.91|1.12||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 24 weeks||1.12|0.91|0.837
71884594|NCT04986202|143289218|SUPERIORITY||Geometric mean ratio|0.95||||0.37|TWO_SIDED|95.0|0.84|1.07||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.07|0.84|0.370
71884595|NCT04986202|143289218|SUPERIORITY||Geometric mean ratio|0.93||||0.205|TWO_SIDED|95.0|0.83|1.04||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|NT-proBNP change from baseline at 48 weeks||1.04|0.83|0.205
71884596|NCT04986202|143289219|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.183|TWO_SIDED|95.0|-0.2|1.2||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.2|-0.2|0.183
71884597|NCT04986202|143289219|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-0.8|0.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||0.7|-0.8|0.898
71884598|NCT04986202|143289219|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.316|TWO_SIDED|95.0|-0.4|1.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.1|-0.4|0.316
71884599|NCT04986202|143289219|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.934|TWO_SIDED|95.0|-0.7|0.8||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||0.8|-0.7|0.934
71884600|NCT04986202|143289220|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.725|TWO_SIDED|95.0|-1.647|2.366||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||2.366|-1.647|0.725
71884601|NCT04986202|143289220|SUPERIORITY||Mean Difference (Final Values)|-0.594||||0.555|TWO_SIDED|95.0|-2.571|1.382||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.382|-2.571|0.555
71884602|NCT04986202|143289220|SUPERIORITY||Mean Difference (Final Values)|0.657||||0.586|TWO_SIDED|95.0|-1.71|3.025||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||3.025|-1.710|0.586
71884603|NCT04986202|143289220|SUPERIORITY||Mean Difference (Final Values)|-0.815||||0.486|TWO_SIDED|95.0|-3.108|1.478||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.478|-3.108|0.486
71884604|NCT04986202|143289221|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.968|TWO_SIDED|95.0|-4.1|3.9||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||3.9|-4.1|0.968
71884605|NCT04986202|143289221|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.251|TWO_SIDED|95.0|-6.3|1.6||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.6|-6.3|0.251
71884606|NCT04986202|143289221|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.872|TWO_SIDED|95.0|-4.8|5.7||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Difference in adjusted mean change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||5.7|-4.8|0.872
71884607|NCT04986202|143289221|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|No formal hypothesis testing and p-value is not adjusted for multiple comparisons.|Change from baseline at 24 weeks||4.1|-6.2|0.682
71884608|NCT04986202|143289223|SUPERIORITY||Geometric mean ratio|1.029||||0.76|TWO_SIDED|95.0|0.857|1.236||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.236|0.857|0.760
71884609|NCT04986202|143289223|SUPERIORITY||Geometric mean ratio|1.209||||0.039|TWO_SIDED|95.0|1.01|1.448||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the baseline value are included in the model as explanatory variables.|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Change from baseline at 16 weeks||1.448|1.010|0.039
71884610|NCT04986202|143289223|SUPERIORITY||Geometric mean ratio|1.111||||0.241|TWO_SIDED|95.0|0.931|1.326||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.326|0.931|0.241
71884611|NCT04986202|143289223|SUPERIORITY||Geometric mean ratio|1.19||||0.049|TWO_SIDED|95.0|1.001|1.414||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.414|1.001|0.049
71884612|NCT04986202|143289223|SUPERIORITY||Geometric mean ratio|1.151||||0.158|TWO_SIDED|95.0|0.946|1.401||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.401|0.946|0.158
71884613|NCT04986202|143289223|SUPERIORITY||Geometric mean ratio|1.159||||0.131|TWO_SIDED|95.0|0.957|1.404||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.404|0.957|0.131
71890492|NCT01032629|143302407|OTHER||Difference of Least Square Mean|-2.96|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|95.0|-3.998|-1.914||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.914|-3.998|
71823081|NCT01033643|143149550|OTHER||Accumulation or Geometric Mean Ratio|1.91|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 10) divided by the first day of multiple dosing of MK-3614 (Day 1).|||||
71823082|NCT01033643|143149551|OTHER||Accumulation or Geometric Mean Ratio|1.38|||||||||||||Accumulation ratio or GMR was calculated as last day of multiple dosing of MK-3614 (Day 13) divided by the first day of multiple dosing of MK-3614 (Day 4).|||||
71823083|NCT01033643|143149558|OTHER|Linear Model|Mean Difference from Placebo|-4.17|||||TWO_SIDED|90.0|-9.53|1.2||||||||1.20|-9.53|
71823084|NCT01033643|143149558|OTHER|Linear Model|Mean Difference from Placebo|4.78|||||TWO_SIDED|90.0|-1.41|10.97||||||||10.97|-1.41|
71823085|NCT01033643|143149558|OTHER|Linear Model|Mean Difference from Placebo|-3.47|||||TWO_SIDED|90.0|-8.37|1.42||||||||1.42|-8.37|
71823086|NCT01033643|143149558|OTHER|Linear Model|Mean Difference from Placebo|3.53|||||TWO_SIDED|90.0|-1.37|8.42||||||||8.42|-1.37|
71823087|NCT01033643|143149559|OTHER|Linear Model|Mean Difference from Placebo|0.23|||||TWO_SIDED|90.0|-6.91|7.36||||||||7.36|-6.91|
71823088|NCT01033643|143149559|OTHER|Linear Model|Mean Difference from Placebo|-1.66|||||TWO_SIDED|90.0|-8.79|5.47||||||||5.47|-8.79|
71823089|NCT01033643|143149559|OTHER|Linear Model|Mean Difference from Placebo|2.11|||||TWO_SIDED|90.0|-5.02|9.25||||||||9.25|-5.02|
71823090|NCT01033643|143149559|OTHER|Linear Model|Mean Difference from Placebo|-1.23|||||TWO_SIDED|90.0|-9.41|6.94||||||||6.94|-9.41|
71823091|NCT01033643|143149560|OTHER|Linear Model|Mean Difference from Placebo|-0.75|||||TWO_SIDED|90.0|-9.29|7.79||||||||7.79|-9.29|
71823092|NCT01033643|143149560|OTHER|Linear Model|Mean Difference from Placebo|-3.73|||||TWO_SIDED|90.0|-14.32|6.86||||||||6.86|-14.32|
71823093|NCT01033643|143149560|OTHER|Linear Model|Mean Difference from Placebo|0.66|||||TWO_SIDED|90.0|-7.88|9.2||||||||9.20|-7.88|
71823094|NCT01033643|143149560|OTHER|Linear Model|Mean Difference from Placebo|-9.92|||||TWO_SIDED|90.0|-19.54|-0.3||||||||-0.30|-19.54|
71823095|NCT01033643|143149561|OTHER|Linear Model|Mean Difference from Placebo|-1.02|||||TWO_SIDED|90.0|-9.36|7.32||||||||7.32|-9.36|
71823096|NCT01033643|143149561|OTHER|Linear Model|Mean Difference from Placebo|-2.12|||||TWO_SIDED|90.0|-12.47|8.22||||||||8.22|-12.47|
71823097|NCT01033643|143149561|OTHER|Linear Model|Mean Difference from Placebo|-0.53|||||TWO_SIDED|90.0|-8.87|7.81||||||||7.81|-8.87|
71823098|NCT01033643|143149561|OTHER|Linear Model|Mean Difference from Placebo|-10.44|||||TWO_SIDED|90.0|-19.83|-1.04||||||||-1.04|-19.83|
71823099|NCT01033643|143149562|OTHER|Linear Model|Mean Difference from Placebo|-1.73|||||TWO_SIDED|90.0|-6.5|3.04||||||||3.04|-6.50|
71823100|NCT01033643|143149562|OTHER|Linear Model|Mean Difference from Placebo|-4.23|||||TWO_SIDED|90.0|-9.0|0.54||||||||0.54|-9.00|
71823101|NCT01033643|143149562|OTHER|Linear Model|Mean Difference from Placebo|-1.05|||||TWO_SIDED|90.0|-5.82|3.72||||||||3.72|-5.82|
71823102|NCT01033643|143149562|OTHER|Linear Model|Mean Difference from Placebo|-2.0|||||TWO_SIDED|90.0|-3.46|7.46||||||||7.46|-3.46|
71823103|NCT01033643|143149563|OTHER|Linear Model|Mean Difference from Placebo|-3.87|||||TWO_SIDED|90.0|-9.37|1.64||||||||1.64|-9.37|
71823104|NCT01033643|143149563|OTHER|Linear Model|Mean Difference from Placebo|-7.2|||||TWO_SIDED|90.0|-14.03|-0.37||||||||-0.37|-14.03|
71823105|NCT01033643|143149563|OTHER|Linear Model|Mean Difference from Placebo|-1.33|||||TWO_SIDED|90.0|-6.83|4.18||||||||4.18|-6.83|
71823106|NCT01033643|143149563|OTHER|Linear Model|Mean Difference from Placebo|-2.24|||||TWO_SIDED|90.0|-8.45|3.96||||||||3.96|-8.45|
71823107|NCT01033643|143149564|OTHER|Linear Model|Mean Difference from Placebo|-2.74|||||TWO_SIDED|90.0|-7.92|2.43||||||||2.43|-7.92|
71823108|NCT01033643|143149564|OTHER|Linear Model|Mean Difference from Placebo|-6.67|||||TWO_SIDED|90.0|-13.09|-0.25||||||||-0.25|-13.09|
71823109|NCT01033643|143149564|OTHER|Linear Model|Mean Difference from Placebo|-0.74|||||TWO_SIDED|90.0|-5.91|4.44||||||||4.44|-5.91|
71823110|NCT01033643|143149564|OTHER|Linear Model|Mean Difference from Placebo|-2.81|||||TWO_SIDED|90.0|-8.64|3.02||||||||3.02|-8.64|
71823111|NCT01033643|143149565|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.47|1.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.87|0.47|
71823112|NCT01033643|143149565|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|90.0|0.26|0.87|||||GMR was calculated as MK-3614 Dose divided by Placebo|||0.87|0.26|
71823113|NCT01033643|143149565|OTHER|Linear Model|Geometric Mean Ratio (GMR)|0.95|||||TWO_SIDED|90.0|0.51|1.79|||||GMR was calculated as MK-3614 Dose divided by Placebo|||1.79|0.51|
71823114|NCT00951561|143149594|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.|Difference in % of Uses from Mixed Model|-1.6|||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
71823115|NCT02092987|143149595|SUPERIORITY_OR_OTHER_LEGACY||interaction term|||||0.7|||||||Mixed Models Analysis|||Hypothesis testing in changes in mean from baseline to follow-up were were conducted primarily with mixed models. Sensitivity analyses were conducted using ANOVA.||||0.70
71823116|NCT02092987|143149596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||comparison of arms using mixed models|Mixed Models Analysis|||||||0.77
71823117|NCT02092987|143149597|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
71823118|NCT02092987|143149598|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
71823119|NCT02092987|143149599|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
71823120|NCT02092987|143149600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
71823121|NCT02092987|143149601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
71823122|NCT02373813|143149612|SUPERIORITY||Risk Difference (RD)|20.8|STANDARD_ERROR_OF_MEAN|6.7||0.004|TWO_SIDED|95.0|7.6|33.9||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||33.9|7.6|0.004
71823123|NCT02373813|143149613|SUPERIORITY||Risk Difference (RD)|24.2|STANDARD_ERROR_OF_MEAN|8.3||0.006|TWO_SIDED|95.0|7.9|40.5||The risk difference and its p-value were estimated from the chi-squared test with continuity correction.|Chi-squared, Corrected|||||40.5|7.9|0.006
71884614|NCT04986202|143289224|SUPERIORITY||Geometric mean ratio|1.0111||||0.874|TWO_SIDED|95.0|0.8819|1.1592||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.1592|0.8819|0.874
71884615|NCT04986202|143289224|SUPERIORITY||Geometric mean ratio|0.9157||||0.2|TWO_SIDED|95.0|0.8002|1.0479||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 16 weeks||1.0479|0.8002|0.200
71890493|NCT01032629|143302407|OTHER||Difference of Least Square Mean|-4.53|STANDARD_ERROR_OF_MEAN|0.534|||TWO_SIDED|95.0|-5.579|-3.484||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-3.484|-5.579|
71890494|NCT01032629|143302407|OTHER||Difference of Least Square Mean|-0.82|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-1.437|-0.205||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-0.205|-1.437|
71890495|NCT01032629|143302407|OTHER||Difference of Least Square Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.316|||TWO_SIDED|95.0|-2.245|-1.007||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.||-1.007|-2.245|
71890496|NCT01032629|143302408|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.04|0.07||||||Comparison for canagliflozin versus placebo is reported here.||0.070|-0.040|
71890497|NCT01032629|143302408|OTHER||Hodges-Lehman Estimate|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||Comparison for canagliflozin versus placebo is reported here.||0.080|-0.030|
71890498|NCT01032629|143302409|OTHER||Difference of Least Square Mean|0.18|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.105|0.259||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.259|0.105|
71890499|NCT01032629|143302409|OTHER||Difference of Least Square Mean|0.23|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|0.152|0.307||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.||0.307|0.152|
71890500|NCT01032629|143302409|OTHER||Difference of Least Square Mean|0.05|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.031|0.065||||||Statistical analysis (HDL-C)||0.065|0.031|
71890501|NCT01032629|143302409|OTHER||Difference of Least Square Mean|0.06|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|95.0|0.04|0.075||||||Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here.||0.075|0.040|
71890502|NCT01032629|143302409|OTHER||Difference of Least Square Mean|0.11|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.046|0.17||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.170|0.046|
71890503|NCT01032629|143302409|OTHER||Difference of Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.102|0.226||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.||0.226|0.102|
71890504|NCT01032629|143302410|OTHER||Difference of Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.04|0.076||||||||0.076|-0.040|
71890505|NCT01032629|143302410|OTHER||Difference of Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.023|0.094||||||||0.094|-0.023|
71890506|NCT00516919|143302411|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.45|||=|0.51||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at post-treatment, controlling for baseline BMI.||||=0.51
71945328|NCT00272779|143413779|SUPERIORITY_OR_OTHER|||||||0.0058||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_2265 reported in Outcome Measure 16.||||0.0058
71890507|NCT00516919|143302411|SUPERIORITY_OR_OTHER_LEGACY||F statistic|0.69|||=|0.41||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.||||=0.41
71890508|NCT00977470|143302419|EQUIVALENCE|All enrolled patients will be included in the intent-to-treat efficacy analyses. Based on historical patients with EGFR mutations treated with gefitinib, we expect median progression-free survival on the erlotinib-alone arm to be approximately 9 months. This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus HCQ arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test.||||||0.28|||||||Log Rank|||||||0.28
71890509|NCT01173653|143302451|SUPERIORITY_OR_OTHER||Chi square|23.02|||<|0.05|||||||Chi-squared|||||||<0.05
71890510|NCT03359902|143302467|SUPERIORITY||beta|1.4||||0.11|TWO_SIDED||||||Mixed Models Analysis|||"A linear mixed effects model was conducted to account for carryover and order effects in this crossover trial.~Assuming α = 0.05, two-sided test, and 60 participants in total. If the carryover effect is negligible, we will have 90% power to detect an effect size of 0.604 for memory improvement"||||0.11
71890511|NCT00151892|143302468|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.|Difference in proportions|0.02||||||95.0|-0.04|0.08||||||The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.||0.08|-0.04|
71890512|NCT03303989|143302477|SUPERIORITY|Efficacy of MMF was examined by the proportion of responders in MMF+Peg compared to PBO+Peg. Rates of the primary outcome were compared using proportions and 95% confidence intervals and tested for differences using Fisher's exact test.|||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||Fisher's exact tests were performed to compare baseline and clinical characteristics between treatment groups as appropriate.||||<0.01
71823124|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|95.0|-0.48|0.27|||two sample t-test|||Baseline||0.27|-0.48|0.58
71823125|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.85|TWO_SIDED|95.0|-0.37|0.31|||two sample t-test|||Baseline||0.31|-0.37|0.85
71823126|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-2.61|STANDARD_ERROR_OF_MEAN|1.66||0.12|TWO_SIDED|95.0|-5.89|0.67|||two sample t-test|||Week 12||0.67|-5.89|0.12
71823127|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-2.64|STANDARD_ERROR_OF_MEAN|1.26||0.037|TWO_SIDED|95.0|-5.12|-0.16|||two sample t-test|||Week 12||-0.16|-5.12|0.037
71823128|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-2.33|STANDARD_ERROR_OF_MEAN|1.46||0.063|TWO_SIDED|95.0|-4.8|0.13|||two sample t-test|||Week 24||0.13|-4.80|0.063
71823129|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.34||0.64|TWO_SIDED|95.0|-3.27|2.01|||two sample t-test|||Week 24||2.01|-3.27|0.64
71823130|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.9||0.031|TWO_SIDED|95.0|-3.09|-0.15|||two sample t-test|||Week 36||-0.15|-3.09|0.031
71823131|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-1.77|STANDARD_ERROR_OF_MEAN|0.71||0.015|TWO_SIDED|95.0|-3.2|-0.35|||two sample t-test|||Week 36||-0.35|-3.20|0.015
71823132|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.87||0.58|TWO_SIDED|95.0|-2.55|1.45|||two sample t-test|||Week 48||1.45|-2.55|0.58
71823133|NCT02373813|143149614|SUPERIORITY||Treatment Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.45||0.02|TWO_SIDED|95.0|-1.99|-0.17|||two sample t-test|||Week 48||-0.17|-1.99|0.020
71823134|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED|95.0|-5.68|0.77|||two sample t-test|||Change at Week 12||0.77|-5.68|0.13
71823135|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.25||0.045|TWO_SIDED|95.0|-4.99|-0.06|||two sample t-test|||Change at Week 12||-0.06|-4.99|0.045
71823136|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-2.27|STANDARD_ERROR_OF_MEAN|1.45||0.071|TWO_SIDED|95.0|-4.75|0.2|||two sample t-test|||Change at Week 24||0.20|-4.75|0.071
71823137|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-0.64|STANDARD_ERROR_OF_MEAN|1.34||0.63|TWO_SIDED|95.0|-3.28|2.0|||two sample t-test|||Change at Week 24||2.00|-3.28|0.63
71823138|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.91||0.037|TWO_SIDED|95.0|-3.11|-0.1|||two sample t-test|||Change at Week 36||-0.10|-3.11|0.037
71823139|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|0.73||0.013|TWO_SIDED|95.0|-3.3|-0.39|||two sample t-test|||Change at Week 36||-0.39|-3.30|0.013
71823140|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.62|TWO_SIDED|95.0|-2.54|1.53|||two sample t-test|||Change at Week 48||1.53|-2.54|0.62
71823141|NCT02373813|143149615|SUPERIORITY||Treatment Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.45||0.015|TWO_SIDED|95.0|-2.02|-0.22|||two sample t-test|||Change at Week 48||-0.22|-2.02|0.015
71823142|NCT02373813|143149616|SUPERIORITY||Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.75|TWO_SIDED|95.0|-0.19|0.26|||two sample t-test|||Baseline||0.26|-0.19|0.75
71823143|NCT02373813|143149616|SUPERIORITY||Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED|95.0|-0.11|0.27|||two sample t-test|||Baseline||0.27|-0.11|0.43
71823144|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.91|0.0|||two sample t-test|||Week 12||0.00|-0.91|0.049
71823145|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.032|TWO_SIDED|95.0|-0.77|-0.04|||two sample t-test|||Week 12||-0.04|-0.77|0.032
71823146|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.18|TWO_SIDED|95.0|-0.58|0.11|||two sample t-test|||Week 24||0.11|-0.58|0.18
71823147|NCT02373813|143149616|SUPERIORITY||Treatment Difference|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED|95.0|-0.24|0.51|||two sample t-test|||Week 24||0.51|-0.24|0.48
71823148|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.35|TWO_SIDED|95.0|-0.51|0.18|||two sample t-test|||Week 36||0.18|-0.51|0.35
71823149|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.41|0.12|||two sample t-test|||Week 36||0.12|-0.41|0.28
71823150|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.48|TWO_SIDED|95.0|-0.44|0.21|||two sample t-test|||Week 48||0.21|-0.44|0.48
71823151|NCT02373813|143149616|SUPERIORITY||Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.92|TWO_SIDED|95.0|-0.26|0.24|||two sample t-test|||Week 48||0.24|-0.26|0.92
71823152|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.91|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.91|0.032
71823153|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED|95.0|-0.78|-0.15|||two sample t-test|||Change at Week 12||-0.15|-0.78|0.005
71823154|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.058|TWO_SIDED|95.0|-0.63|0.01|||two sample t-test|||Change at Week 24||0.01|-0.63|0.058
71823155|NCT02373813|143149617|SUPERIORITY||Treatment Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||two sample t-test|||Change at Week 24||0.38|-0.29|0.78
71823156|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.27|TWO_SIDED|95.0|-0.49|0.14|||two sample t-test|||Change at Week 36||0.14|-0.49|0.27
71823157|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.078|TWO_SIDED|95.0|-0.47|0.03|||two sample t-test|||Change at Week 36||0.03|-0.47|0.078
71823158|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.47|TWO_SIDED|95.0|-0.43|0.2|||two sample t-test|||Week 48||0.20|-0.43|0.47
71823159|NCT02373813|143149617|SUPERIORITY||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.39|TWO_SIDED|95.0|-0.33|0.13|||two sample t-test|||Change at Week 48||0.13|-0.33|0.39
71823160|NCT02373813|143149618|SUPERIORITY||Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6|TWO_SIDED|95.0|-0.09|0.15|||two sample t-test|||Baseline||0.15|-0.09|0.60
71884616|NCT04986202|143289224|SUPERIORITY||Geometric mean ratio|1.1063||||0.135|TWO_SIDED|95.0|0.969|1.2631||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2631|0.9690|0.135
71823161|NCT02373813|143149618|SUPERIORITY||Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED|95.0|-0.1|0.1|||two sample t-test|||Baseline||0.10|-0.10|0.97
71823162|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.044|TWO_SIDED|95.0|-0.82|-0.01|||two sample t-test|||Week 12||-0.01|-0.82|0.044
71823163|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.76|-0.14|||two sample t-test|||Week 12||-0.14|-0.76|0.004
71823164|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.009|TWO_SIDED|95.0|-0.66|-0.1|||two sample t-test|||Week 24||-0.10|-0.66|0.009
71823165|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Week 24||0.16|-0.46|0.34
71823166|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.046|TWO_SIDED|95.0|-0.47|0.0|||two sample t-test|||Week 36||0.00|-0.47|0.046
71823167|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.49|-0.08|||two sample t-test|||Week 36||-0.08|-0.49|0.006
71823168|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.25|TWO_SIDED|95.0|-0.4|-0.1|||two sample t-test|||Week 48||-0.10|-0.40|0.25
71823169|NCT02373813|143149618|SUPERIORITY||Treatment Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.37|-0.03|||two sample t-test|||Week 48||-0.03|-0.37|0.021
71823170|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.82|-0.04|||two sample t-test|||Change at Week 12||-0.04|-0.82|0.030
71823171|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.005|TWO_SIDED|95.0|-0.72|-0.13|||two sample t-test|||Change at Week 12||-0.13|-0.72|0.005
71823172|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.69|-0.15|||two sample t-test|||Change at Week 24||-0.15|-0.69|0.002
71823173|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.34|TWO_SIDED|95.0|-0.46|0.16|||two sample t-test|||Change at Week 24||0.16|-0.46|0.34
71823174|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.014|TWO_SIDED|95.0|-0.52|-0.06|||two sample t-test|||Change at Week 36||-0.06|-0.52|0.014
71823175|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.51|-0.1|||two sample t-test|||Change at Week 36||-0.10|-0.51|0.004
71823176|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.43|0.05|||two sample t-test|||Change at Week 48||0.05|-0.43|0.12
71823177|NCT02373813|143149619|SUPERIORITY||Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.01|TWO_SIDED|95.0|-0.37|-0.05|||two sample t-test|||Change at Week 48||-0.05|-0.37|0.010
71823178|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|-0.62|0.02|||two sample t-test|||Baseline||0.02|-0.62|0.067
71823179|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.59|TWO_SIDED|95.0|-0.41|0.23|||two sample t-test|||Baseline||0.23|-0.41|0.59
71823180|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-2.46|STANDARD_ERROR_OF_MEAN|1.62||0.13||95.0|-5.66|0.74|||two sample t-test|||Week 12||0.74|-5.66|0.13
71823181|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-2.34|STANDARD_ERROR_OF_MEAN|1.23||0.059|TWO_SIDED|95.0|-4.76|0.09|||two sample t-test|||Week 12||0.09|-4.76|0.059
71823182|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-2.72|STANDARD_ERROR_OF_MEAN|1.38||0.017|TWO_SIDED|95.0|-4.95|-0.5|||two sample t-test|||Week 24||-0.50|-4.95|0.017
71823183|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.32||0.74|TWO_SIDED|95.0|-3.04|2.15|||two sample t-test|||Week 24||2.15|-3.04|0.74
71823184|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-3.03|-0.08|||two sample t-test|||Week 36||-0.08|-3.03|0.039
71823185|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.72||0.023|TWO_SIDED|95.0|-3.1|-0.23|||two sample t-test|||Week 36||-0.23|-3.10|0.023
71823186|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.85||0.65|TWO_SIDED|95.0|-2.43|1.52|||two sample t-test|||Week 48||1.52|-2.43|0.65
71823187|NCT02373813|143149620|SUPERIORITY||Treatment Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.44||0.017|TWO_SIDED|95.0|-1.94|-0.19|||two sample t-test|||Week 48||-0.19|-1.94|0.017
71823188|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-2.15|STANDARD_ERROR_OF_MEAN|1.59||0.18||95.0|-5.29|1.0|||two sample t-test|||Change at Week 12||1.00|-5.29|0.18
71823189|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.21||0.067|TWO_SIDED|95.0|-4.63|0.16|||two sample t-test|||Change at Week 12||0.16|-4.63|0.067
71823190|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.37||0.035|TWO_SIDED|95.0|-4.62|-0.17|||two sample t-test|||Change at Week 24||-0.17|-4.62|0.035
71823191|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.3||0.79|TWO_SIDED|95.0|-2.91|2.23|||two sample t-test|||Change at Week 24||2.23|-2.91|0.79
71823192|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.91||0.09|TWO_SIDED|95.0|-2.75|0.2|||two sample t-test|||Change at Week 36||0.20|-2.75|0.090
71823193|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.72||0.029|TWO_SIDED|95.0|-3.06|-0.17|||two sample t-test|||Change at Week 36||-0.17|-3.06|0.029
71823194|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.84||0.86|TWO_SIDED|95.0|-2.15|1.81|||two sample t-test|||Change at Week 48||1.81|-2.15|0.86
71823195|NCT02373813|143149621|SUPERIORITY||Treatment Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.43||0.021|TWO_SIDED|95.0|-1.88|-0.16|||two sample t-test|||Change at Week 48||-0.16|-1.88|0.021
71884617|NCT04986202|143289224|SUPERIORITY||Geometric mean ratio|1.0842||||0.22|TWO_SIDED|95.0|0.9527|1.2339||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 24 weeks||1.2339|0.9527|0.220
71884618|NCT04986202|143289224|SUPERIORITY||Geometric mean ratio|1.0496||||0.467|TWO_SIDED|95.0|0.9211|1.196||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1960|0.9211|0.467
71884619|NCT04986202|143289224|SUPERIORITY||Geometric mean ratio|1.0312||||0.636|TWO_SIDED|95.0|0.908|1.1711||Two-sided test.|ANCOVA|Treatment group, neutrophil count stratification factor and the log-transformed baseline value are included in the model as explanatory variables.|Geometric mean ratio in change from baseline between AZD4831 and placebo.|Change from baseline at 48 weeks||1.1711|0.9080|0.636
71884620|NCT01885000|143289240|SUPERIORITY||||||=|0.0065|||||||Cochran-Mantel-Haenszel|||||||= 0.0065
71884621|NCT01885000|143289241|SUPERIORITY||||||=|0.0328|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who satisfied with appearance.||||= 0.0328
71884622|NCT01885000|143289241|SUPERIORITY||||||=|0.5312|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance acceptable.||||= 0.5312
71884623|NCT01885000|143289241|SUPERIORITY||||||=|0.0756|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who appearance concerned.||||= 0.0756
71884624|NCT01885000|143289241|SUPERIORITY||||||=|0.0083|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who embarrassed with facial redness.||||= 0.0083
71884625|NCT01885000|143289241|SUPERIORITY||||||=|0.0076|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who self-conscious.||||= 0.0076
71884626|NCT01885000|143289241|SUPERIORITY||||||=|0.2186|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who's frequency control last 24 hours||||= 0.2186
71884627|NCT01885000|143289241|SUPERIORITY||||||=|0.2373|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who are frustrated.||||= 0.2373
71884628|NCT01885000|143289241|SUPERIORITY||||||=|0.7769|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who cover up or camouflage.||||= 0.7769
71884629|NCT01885000|143289241|SUPERIORITY||||||=|0.8764|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who pay attention to the known triggers.||||= 0.8764
71884630|NCT01885000|143289241|SUPERIORITY||||||=|0.6149|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who avoid the known triggers.||||= 0.6149
71884631|NCT01885000|143289241|SUPERIORITY||||||=|0.8361|||||||Cochran-Mantel-Haenszel|||The questionnaire analyzed and reported here is for participants who interfering with social life.||||= 0.8361
71701099|NCT02469233|142918218|SUPERIORITY||Time by treatment interaction coeff.|-5.37||||0.027|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.027
71884632|NCT01885000|143289241|SUPERIORITY||||||=|0.6259|||||||Cochran-Mantel-Haenszel|||Interfering with work life||||= 0.6259
71884633|NCT01885000|143289242|SUPERIORITY||||||=|0.5821|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Mobility.||||= 0.5821
71884634|NCT01885000|143289242|SUPERIORITY||||||=|0.8864|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Self-Care.||||= 0.8864
71884635|NCT01885000|143289242|SUPERIORITY||||||=|0.9579|||||||Cochran-Mantel-Haenszel|||This analysis was performed for usual activities.||||= 0.9579
71884636|NCT01885000|143289242|SUPERIORITY||||||=|0.1344|||||||Cochran-Mantel-Haenszel|||This analysis was performed for Pain/Discomfort.||||= 0.1344
71884637|NCT01885000|143289242|SUPERIORITY||||||=|0.1881|||||||Cochran-Mantel-Haenszel|||Anxiety/Depression||||= 0.1881
71884638|NCT01885000|143289243|SUPERIORITY||||||=|0.3935|||||||Cochran-Mantel-Haenszel|||||||= 0.3935
71884639|NCT01885000|143289244|SUPERIORITY||||||=|0.4162|||||||Cochran-Mantel-Haenszel|||||||= 0.4162
71884640|NCT03124784|143289249|EQUIVALENCE|ARMS\<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS\< 3 % SpO2.|ARMS|0.0|||||TWO_SIDED|||||||||Accuracy Root Mean Square (ARMS)|Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.|||
71884641|NCT05726318|143289296|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
71884642|NCT05726318|143289298|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
71884643|NCT05726318|143289299|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||.68
71884644|NCT05726318|143289301|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||.78
71884645|NCT05726318|143289302|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71884646|NCT01415752|143289307|SUPERIORITY|||||||0.25||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.25
71884647|NCT01415752|143289308|SUPERIORITY|||||||0.178||||||one-sided stratified log-rank test|Log Rank|one-sided stratified log-rank test||||||0.178
71884648|NCT01903837|143289355|EQUIVALENCE|Equivalence margin of 10 points|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-2.0|2.6|||Least Square Mean Difference|||||2.6|-2.0|0.3
71884649|NCT01903837|143289356|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71884650|NCT01903837|143289356|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71884651|NCT01903837|143289357|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71884652|NCT01903837|143289357|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71884653|NCT01081795|143289369|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.4||||0.1646|TWO_SIDED|95.0|-1.0|0.2||Analysis of covariance (ANCOVA) method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1646
71884654|NCT01081795|143289369|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4479|TWO_SIDED|95.0|-0.8|0.4||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.4|-0.8|0.4479
71884655|NCT01081795|143289370|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1547|TWO_SIDED|95.0|-1.1|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.1|0.1547
71701100|NCT02469233|142918219|SUPERIORITY||Time by treatment interaction coeff.|-0.95||||0.32|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.32
71823196|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.4||1|TWO_SIDED|95.0|-6.5|6.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||6.6|-6.5|1.00
71823197|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|-3.9|STANDARD_ERROR_OF_MEAN|3.3||0.38|TWO_SIDED|95.0|-10.4|2.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||2.6|-10.4|0.38
71884656|NCT01081795|143289370|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2624|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2624
71884657|NCT01081795|143289371|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2464|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.2464
71884658|NCT01081795|143289371|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3148|TWO_SIDED|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.0|0.3148
71884659|NCT01081795|143289372|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.8762|TWO_SIDED|95.0|-0.6|0.5||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.5|-0.6|0.8762
71884660|NCT01081795|143289372|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.3031|TWO_SIDED|95.0|-0.8|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-0.8|0.3031
71884661|NCT01081795|143289373|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.1145|TWO_SIDED|95.0|-0.7|0.1||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.1|-0.7|0.1145
71884662|NCT01081795|143289373|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.3971|TWO_SIDED|95.0|-0.6|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-0.6|0.3971
71884663|NCT01081795|143289374|SUPERIORITY_OR_OTHER||LS mean difference|-0.5||||0.1866|TWO_SIDED|95.0|-1.3|0.3||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.3|-1.3|0.1866
71884664|NCT01081795|143289374|SUPERIORITY_OR_OTHER||LS mean difference|-0.6||||0.1507|TWO_SIDED|95.0|-1.4|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.4|0.1507
71884665|NCT01081795|143289376|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.1743|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.1743
71884666|NCT01081795|143289376|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.2165|TWO_SIDED|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA|||||0.2|-1.0|0.2165
71884667|NCT01081795|143289377|SUPERIORITY_OR_OTHER||Percentage difference|5.1||||0.3083|TWO_SIDED|95.0|-3.8|14.0||Month 6|Fisher Exact|||||14.0|-3.8|0.3083
71701101|NCT02469233|142918219|SUPERIORITY||Time by treatment interaction coeff.|-1.67||||0.08|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.08
71884668|NCT01081795|143289377|SUPERIORITY_OR_OTHER||Percentage difference|2.0||||0.7235|TWO_SIDED|95.0|-6.6|10.6||Month 6|Fisher Exact|||||10.6|-6.6|0.7235
71884669|NCT01459705|143289433|SUPERIORITY_OR_OTHER||Slope|-22.34|STANDARD_DEVIATION|4.69|||ONE_SIDED|||||||||||||
71884670|NCT01459705|143289433|SUPERIORITY_OR_OTHER||Slope|-13.3|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|||||||||||||
71884671|NCT01459705|143289433|SUPERIORITY_OR_OTHER||Slope|9.04|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|||||||||||||
71884672|NCT01459705|143289434|SUPERIORITY_OR_OTHER||Slope|15.07|STANDARD_DEVIATION|6.03|||TWO_SIDED|||||||||||||
71884673|NCT01459705|143289435|SUPERIORITY_OR_OTHER||Slope|13.91|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|||||||||||||
71884674|NCT01967537|143289522|SUPERIORITY|||||||0.23|||||||Mann-Whitney|||||||0.23
71884675|NCT05130463|143289526|OTHER|||||||0.0011||||||Comparison of the change in HbA1c from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0011
71884676|NCT05130463|143289527|OTHER|||||||0.0014||||||Comparison of the change in HbA1c from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|||||||0.0014
71884677|NCT05130463|143289532|OTHER|||||||0.0008||||||Comparison of the change in FPG from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 12 weeks of treatment.||||0.0008
71884678|NCT05130463|143289533|OTHER|||||||0.0068||||||Comparison of the change in FPG from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||FPG at baseline vs FPG after 24 weeks of treatment.||||0.0068
71884679|NCT05130463|143289534|OTHER|||||||0.1867||||||Comparison of the change in body weight from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level||Body weight at baseline vs Body weight after 12 weeks of treatment.||||0.1867
71701102|NCT02469233|142918220|SUPERIORITY||Time by treatment interaction coeff.|-0.09||||0.72|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.72
71884680|NCT05130463|143289535|OTHER|||||||0.0003||||||Comparison of the change in body weight from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||Body weight at baseline vs Body weight after 24 weeks of treatment.||||0.0003
71884681|NCT05130463|143289536|OTHER|||||||0.002||||||Comparison of the change in SBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 12 weeks of treatment.||||0.0020
71884682|NCT05130463|143289536|OTHER|||||||0.0132||||||Comparison of the change in DBP from baseline to the values at 12 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 12 weeks of treatment.||||0.0132
71884683|NCT05130463|143289537|OTHER|||||||0.7591||||||Comparison of the change in SBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||SBP at baseline vs SBP after 24 weeks of treatment.||||0.7591
71884684|NCT05130463|143289537|OTHER|||||||0.5161||||||Comparison of the change in DBP from baseline to the values at 24 weeks post Esgliteo administration.|t-test, 2 sided|Paired t-test: Statistically significant at a 5% two-sided level.||DBP at baseline vs DBP after 24 weeks of treatment.||||0.5161
71884685|NCT03461757|143289538|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.0001|TWO_SIDED|95.0|6.5|14.2|||Cochran-Mantel-Haenszel|||||14.2|6.5|< 0.0001
71884686|NCT03461757|143289539|SUPERIORITY||Risk Difference (RD)|8.3||||0.0009|TWO_SIDED|95.0|3.4|13.2|||Cochran-Mantel-Haenszel|||||13.2|3.4|0.0009
71884687|NCT03461757|143289540|SUPERIORITY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.8|21.3|||Cochran-Mantel-Haenszel|||||21.3|10.8|< 0.0001
71884688|NCT03461757|143289541|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
71884689|NCT03461757|143289542|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|15.1|25.2|||Cochran-Mantel-Haenszel|||||25.2|15.1|< 0.0001
71884690|NCT03461757|143289543|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.0001|TWO_SIDED|95.0|4.9|13.7|||Cochran-Mantel-Haenszel|||||13.7|4.9|< 0.0001
71884691|NCT03461757|143289544|SUPERIORITY||Risk Difference (RD)|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.3|-10.7|||Cochran-Mantel-Haenszel|||||-10.7|-19.3|< 0.0001
71884692|NCT03461757|143289545|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.0001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|||||17.2|8.3|< 0.0001
71884693|NCT03461757|143289546|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|12.0|21.9|||Cochran-Mantel-Haenszel|||||21.9|12.0|< 0.0001
71884694|NCT03461757|143289547|SUPERIORITY||Risk Difference (RD)|6.8||||0.0018|TWO_SIDED|95.0|2.5|11.0|||Cochran-Mantel-Haenszel|||||11.0|2.5|0.0018
71884695|NCT03461757|143289548|SUPERIORITY||Risk Difference (RD)|10.6|||<|0.0001|TWO_SIDED|95.0|6.3|14.9|||Cochran-Mantel-Haenszel|||||14.9|6.3|< 0.0001
71884696|NCT03461757|143289549|SUPERIORITY||Risk Difference (RD)|8.8||||0.0007|TWO_SIDED|95.0|3.7|13.9|||Cochran-Mantel-Haenszel|||||13.9|3.7|0.0007
71884697|NCT03461757|143289550|SUPERIORITY||Risk Difference (RD)|8.9||||0.0002|TWO_SIDED|95.0|4.3|13.6|||Cochran-Mantel-Haenszel|||||13.6|4.3|0.0002
71884698|NCT03461757|143289551|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|7.1|17.6|||Cochran-Mantel-Haenszel|||||17.6|7.1|< 0.0001
71884699|NCT03461757|143289552|SUPERIORITY||Risk Difference (RD)|10.1|||<|0.0001|TWO_SIDED|95.0|6.9|13.4|||Cochran-Mantel-Haenszel|||||13.4|6.9|< 0.0001
71884700|NCT03461757|143289553|SUPERIORITY||Risk Difference (RD)|5.8||||0.0128|TWO_SIDED|95.0|1.2|10.4|||Cochran-Mantel-Haenszel|||||10.4|1.2|0.0128
71884701|NCT03461757|143289554|SUPERIORITY||Risk Difference (RD)|7.8|||<|0.0001|TWO_SIDED|95.0|4.4|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.4|< 0.0001
71884702|NCT03461757|143289555|SUPERIORITY||Risk Difference (RD)|11.5||||0.0003|TWO_SIDED|95.0|5.3|17.7|||Cochran-Mantel-Haenszel|||||17.7|5.3|0.0003
71884703|NCT03461757|143289556|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.0001|TWO_SIDED|95.0|4.9|11.1|||Cochran-Mantel-Haenszel|||||11.1|4.9|< 0.0001
71884704|NCT03461757|143289557|SUPERIORITY||Risk Difference (RD)|5.5||||0.0314|TWO_SIDED|95.0|0.5|10.6|||Cochran-Mantel-Haenszel|||||10.6|0.5|0.0314
71884705|NCT03461757|143289558|SUPERIORITY||Risk Difference (RD)|6.4||||0.0025|TWO_SIDED|95.0|2.3|10.6|||Cochran-Mantel-Haenszel|||||10.6|2.3|0.0025
71884706|NCT03461757|143289559|SUPERIORITY||Risk Difference (RD)|5.9||||0.0898|TWO_SIDED|95.0|-0.9|12.7||P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.7|-0.9|0.0898
71884707|NCT03861559|143289565|OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
71884708|NCT03861559|143289566|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884709|NCT03861559|143289568|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884710|NCT03861559|143289569|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884711|NCT03861559|143289570|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884712|NCT03861559|143289572|OTHER|||||||0.14|||||||ANOVA|||||||0.14
71884713|NCT03861559|143289573|OTHER|||||||0.02|||||||ANOVA|||||||0.02
71884714|NCT03861559|143289574|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884715|NCT03861559|143289576|OTHER|||||||0.15|||||||ANOVA|||||||0.15
71884716|NCT03861559|143289577|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884717|NCT03861559|143289578|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884718|NCT03861559|143289580|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884719|NCT03861559|143289581|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884720|NCT03861559|143289582|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884721|NCT03861559|143289583|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884722|NCT03861559|143289584|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884723|NCT03861559|143289585|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71884724|NCT01687712|143289594|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-1.3|8.7|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.7|-1.3|
71884725|NCT01687712|143289595|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (\& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.5|8.1|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF - AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2- p1 \> ∆ and H1: p2- p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."||8.1|-2.5|
71884726|NCT01687712|143289599|SUPERIORITY|Comparisons were tested against a null of zero at the two-side 5% significance level.||||||0.612||||||P-values are based upon Type III sums of squares.|ANCOVA|Treatment group and Site are included as factors.||"The null and alternative hypotheses are as follows:~H0: p2- p1 = 0 and H1: p2- p1 ≠0,~where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group."||||0.612
71884727|NCT03809611|143289685|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.1832|TWO_SIDED|90.0|-1.34|4.56||One-sided p-value for treatment difference|Mixed Models Analysis|||||4.56|-1.34|0.1832
71884728|NCT03809611|143289686|SUPERIORITY||Odds Ratio (OR)|1.9||||0.283|TWO_SIDED|90.0|0.72|4.78|||Cochran-Mantel-Haenszel|||||4.78|0.72|0.2830
71884729|NCT02926950|143289688|SUPERIORITY||Difference in Least Squares (LS) Means|-0.47|STANDARD_ERROR_OF_MEAN|0.084|<|0.0001|TWO_SIDED|95.0|-0.64|-0.309|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.309|-0.64|< 0.0001
71823198|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|24.5|STANDARD_ERROR_OF_MEAN|7.9||0.007|TWO_SIDED|95.0|9.0|40.0|||Chi-squared, Corrected|||Week 12||40.0|9.0|0.007
71823199|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|14.0|STANDARD_ERROR_OF_MEAN|6.9||0.063|TWO_SIDED|95.0|0.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||27.6|0.4|0.063
71823200|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|23.2|STANDARD_ERROR_OF_MEAN|8.4||0.012|TWO_SIDED|95.0|6.7|39.8|||Chi-squared, Corrected|||Week 24||39.8|6.7|0.012
71884730|NCT02926950|143289689|SUPERIORITY||Difference in LS Means|-1.572|STANDARD_ERROR_OF_MEAN|0.2457|<|0.0001|TWO_SIDED|95.0|-2.0538|-1.0909|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline 2- hour postprandial glucose as a covariate.||-1.0909|-2.0538|< 0.0001
71884731|NCT02926950|143289690|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.2247|=|0.0007|TWO_SIDED|95.0|-1.2006|-0.3198|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.3198|-1.2006|= 0.0007
71884732|NCT02926950|143289691|SUPERIORITY||Difference in LS Means|-1.87|STANDARD_ERROR_OF_MEAN|0.369|<|0.0001|TWO_SIDED|95.0|-2.591|-1.144|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and country as fixed effects, and baseline weight as a covariate.||-1.144|-2.591|< 0.0001
71945329|NCT00272779|143413780|SUPERIORITY_OR_OTHER|||||||0.0253||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_598 reported in Outcome Measure 16.||||0.0253
71945330|NCT00272779|143413781|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE\_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_C130R reported in Outcome Measure 16.||||0.1173
71945331|NCT00272779|143413782|SUPERIORITY_OR_OTHER|||||||0.1173||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN\_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_734 reported in Outcome Measure 16.||||0.1173
71945332|NCT00272779|143413783|SUPERIORITY_OR_OTHER|||||||0.1847||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE\_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE\_R176C reported in Outcome Measure 16.||||0.1847
71884733|NCT02926950|143289692|SUPERIORITY||Difference in LS Means|-3.28|STANDARD_ERROR_OF_MEAN|1.422|=|0.0209|TWO_SIDED|95.0|-6.07|-0.497|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.497|-6.07|= 0.0209
71884734|NCT02926950|143289693|SUPERIORITY||Difference in LS Means|-3.54|STANDARD_ERROR_OF_MEAN|0.992|=|0.0004|TWO_SIDED|95.0|-5.479|-1.592|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.592|-5.479|= 0.0004
71884735|NCT02926950|143289694|SUPERIORITY||Percentage Difference|5.4|||=|0.0238|TWO_SIDED|95.0|0.75|10.06|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||10.06|0.75|= 0.0238
71884736|NCT02926950|143289695|SUPERIORITY||Percentage Difference|13.9|||=|0.0001|TWO_SIDED|95.0|6.91|20.89|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening. Missing data at Week 26 were assigned a status of nonresponder in the analysis.||20.89|6.91|= 0.0001
71884737|NCT05110300|143289708|SUPERIORITY|||||||0.0283||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0283
71884738|NCT05110300|143289709|SUPERIORITY|||||||0.3118||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3118
71884739|NCT05110300|143289710|SUPERIORITY|||||||0.213||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.213
71884740|NCT05110300|143289710|EQUIVALENCE|MDC of the inpatient stroke population for the BBS was used as the equivalence bounds. Equivalence bounds were set at +/- 6.9|||||<|0.001||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||||||<0.001
71884741|NCT05110300|143289710|SUPERIORITY|||||||0.32||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.320
71884742|NCT05110300|143289711|SUPERIORITY|||||||0.2612||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.2612
71884743|NCT05110300|143289712|SUPERIORITY|||||||0.541||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5410
71884744|NCT05110300|143289713|SUPERIORITY|||||||0.6282||||||The a priori threshold for statistical significance was p\<0.05.|Wilcoxon (Mann-Whitney)|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.6282
71884745|NCT05110300|143289713|SUPERIORITY|||||||0.5056||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.5056
71884746|NCT05110300|143289714|SUPERIORITY|||||||0.558||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.5580
71884747|NCT05110300|143289715|SUPERIORITY|||||||0.0897||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Mixed Models Analysis|Because some values are missing, these data were analyzed by fitting a mixed model, rather than by repeated measures ANOVA.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0897
71884748|NCT05110300|143289716|SUPERIORITY|||||||0.0549||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.0549
71884749|NCT05110300|143289716|SUPERIORITY|||||||0.05626||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.05626
71884750|NCT05110300|143289717|SUPERIORITY|||||||0.0706||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.0706
71884751|NCT05110300|143289718|SUPERIORITY|||||||0.1629||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.1629
71884752|NCT05110300|143289719|SUPERIORITY|||||||0.4271||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.4271
71884753|NCT05110300|143289719|SUPERIORITY|||||||0.419||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.4190
71884754|NCT05110300|143289720|SUPERIORITY|||||||0.3444||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3444
71884755|NCT05110300|143289721|SUPERIORITY|||||||0.3581||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANOVA|2-Way ANOVA with Fisher's LSD correction for multiple comparisons.||To evaluate if there were differences between pre- and post-intervention data, a 2-way analysis of variance (ANOVA) was utilized, with mixed-effects analysis being utilized when data was missing.||||0.3581
71884756|NCT05110300|143289722|SUPERIORITY|||||||0.906||||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||To evaluate differences in average outcome measure score change from baseline to last study session, a 2-sided t-test was used, with non-parametric analysis used as necessary.||||0.9060
71884757|NCT05110300|143289722|SUPERIORITY|||||||0.0848||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|ANCOVA|ANCOVA, with the number of sessions completed as the covariate.||Because each participant may have had a different number of BWSS sessions completed, an ANCOVA was used to assess for mean differences in outcome score change while controlling for the number of BWSS sessions completed||||0.0848
71884758|NCT01535729|143289724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949|STANDARD_ERROR_OF_MEAN|0.167||0.756|TWO_SIDED|95.0|0.684|1.318|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.318|0.684|0.756
71884759|NCT01535729|143289724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|STANDARD_ERROR_OF_MEAN|0.185||0.11|TWO_SIDED|95.0|0.518|1.07|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.070|0.518|0.110
71823201|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|17.8|STANDARD_ERROR_OF_MEAN|7.0||0.018|TWO_SIDED|95.0|4.1|31.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||31.5|4.1|0.018
71823202|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|19.0|STANDARD_ERROR_OF_MEAN|8.6||0.044|TWO_SIDED|95.0|2.1|35.9|||Chi-squared, Corrected|||Week 36||35.9|2.1|0.044
71823203|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|19.5|STANDARD_ERROR_OF_MEAN|7.0||0.01|TWO_SIDED|95.0|5.8|33.2|||Chi-squared, Corrected|||Week 36||33.2|5.8|0.010
71823204|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|25.7|STANDARD_ERROR_OF_MEAN|8.6||0.005|TWO_SIDED|95.0|8.9|42.5||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||42.5|8.9|0.005
71823205|NCT02373813|143149622|SUPERIORITY||Risk Difference (RD)|21.6|STANDARD_ERROR_OF_MEAN|7.0||0.004|TWO_SIDED|95.0|7.9|35.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||35.2|7.9|0.004
71823206|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|11.1|STANDARD_ERROR_OF_MEAN|8.4||0.25|TWO_SIDED|95.0|-5.4|27.6||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||27.6|-5.4|0.25
71823207|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|6.7||1|TWO_SIDED|95.0|-12.5|13.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Baseline||13.8|-12.5|1.00
71823208|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|1.6|STANDARD_ERROR_OF_MEAN|6.8||0.98|TWO_SIDED|95.0|-11.6|14.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||14.9|-11.6|0.98
71823209|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|5.0|STANDARD_ERROR_OF_MEAN|5.7||0.48|TWO_SIDED|95.0|-6.2|16.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 12||16.2|-6.2|0.48
71823210|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.16|TWO_SIDED|95.0|-3.1|25.7||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||25.7|-3.1|0.16
71823211|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|5.3||0.94|TWO_SIDED|95.0|-9.0|11.9||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 24||11.9|-9.0|0.94
71823212|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|7.4||0.12|TWO_SIDED|95.0|-2.1|27.0||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||27.0|-2.1|0.12
71823213|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|5.6||0.4|TWO_SIDED|95.0|-5.2|16.8||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 36||16.8|-5.2|0.40
71823214|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.63|TWO_SIDED|95.0|-9.8|20.4||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||20.4|-9.8|0.63
71823215|NCT02373813|143149623|SUPERIORITY||Risk Difference (RD)|-6.9|STANDARD_ERROR_OF_MEAN|5.7||0.31|TWO_SIDED|95.0|-18.0|4.2||The risk difference and its p-value were estimated from the Chi-squared test with continuity correction.|Chi-squared, Corrected|||Week 48||4.2|-18.0|0.31
71823216|NCT02373813|143149625|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
71823217|NCT02373813|143149625|SUPERIORITY||||||<|0.001||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||< 0.001
71823218|NCT02373813|143149626|SUPERIORITY|||||||0.31||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.31
71823219|NCT02373813|143149626|SUPERIORITY|||||||0.51||||||P-value was based on the Log-rank test for overall difference on disease-worsening event between two groups.|Log Rank|||||||0.51
71823220|NCT02373813|143149627|SUPERIORITY||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|14.1||0.58|TWO_SIDED|95.0|-15.2|40.2|||Chi-squared, Corrected|||||40.2|-15.2|0.58
71823221|NCT02403674|143149628|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|3.537|||||TWO_SIDED|95.0|-1.951|9.026|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.026|-1.951|
71823222|NCT02403674|143149629|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-28.3|||<|0.001|TWO_SIDED|95.0|-34.0|-22.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Dizziness difference||-22.5|-34.0|<0.001
71823223|NCT02403674|143149629|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-13.5|||<|0.001|TWO_SIDED|95.0|-19.1|-7.9||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Sleep disorders and disturbances difference||-7.9|-19.1|<0.001
71823224|NCT02403674|143149629|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-3.8||||0.033|TWO_SIDED|95.0|-7.6|-0.3||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Altered sensorium difference||-0.3|-7.6|0.033
71823225|NCT02403674|143149630|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.815|||||TWO_SIDED|95.0|-2.412|10.042|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||10.042|-2.412|
71701103|NCT02469233|142918220|SUPERIORITY||Time by treatment interaction coeff.|-0.08||||0.74|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.74
71701104|NCT02469233|142918221|SUPERIORITY||Time by treatment interaction coeff.|-2.46||||0.73|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.73
71823226|NCT02403674|143149631|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|4.1|||||TWO_SIDED|95.0|-1.5|9.7|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.7|-1.5|
71823227|NCT02403674|143149632|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10|Difference in percentages|3.268|||||TWO_SIDED|95.0|-3.057|9.593|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|||9.593|-3.057|
71823228|NCT02403674|143149633|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.|Difference in mean %change from baseline|10.1|||||TWO_SIDED|95.0|-16.1|36.3|||||95% CIs were calculated based on t-distribution.|||36.3|-16.1|
71884760|NCT01535729|143289724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054|STANDARD_ERROR_OF_MEAN|0.242||0.829|TWO_SIDED|95.0|0.656|1.692|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.692|0.656|0.829
71884761|NCT01535729|143289739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.981|STANDARD_ERROR_OF_MEAN|0.143||0.895|TWO_SIDED|95.0|0.741|1.299|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.299|0.741|0.895
71884762|NCT01535729|143289739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689|STANDARD_ERROR_OF_MEAN|0.162||0.022|TWO_SIDED|95.0|0.501|0.947|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||0.947|0.501|0.022
71884763|NCT01535729|143289739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.212||0.479|TWO_SIDED|95.0|0.767|1.759|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.||1.759|0.767|0.479
71884764|NCT01535729|143289740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732|STANDARD_ERROR_OF_MEAN|0.129||0.015|TWO_SIDED|95.0|0.569|0.941|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.941|0.569|0.015
71884765|NCT01535729|143289741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.902|STANDARD_ERROR_OF_MEAN|0.156||0|TWO_SIDED|95.0|1.402|2.582|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.582|1.402|0.000
71884766|NCT01535729|143289741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.786|STANDARD_ERROR_OF_MEAN|0.183||0.002|TWO_SIDED|95.0|1.248|2.557|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.557|1.248|0.002
71884767|NCT01535729|143289744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.535|0.962|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.||0.962|0.535|0.027
71884768|NCT01535729|143289745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.935|STANDARD_ERROR_OF_MEAN|0.179||0|TWO_SIDED|95.0|1.362|2.749|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.749|1.362|0.000
71884769|NCT01535729|143289745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.882|STANDARD_ERROR_OF_MEAN|0.213||0.003|TWO_SIDED|95.0|1.239|2.859|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.||2.859|1.239|0.003
71884770|NCT02787850|143289747|OTHER||sucess proportion|86.8|||||TWO_SIDED|95.0|71.9|95.6||||||||95.6|71.9|
71884771|NCT02787850|143289747|OTHER||success proportion|76.7|||||TWO_SIDED|95.0|57.7|90.1||||||||90.1|57.7|
71884772|NCT02787850|143289747|OTHER||success proportion|87.7|||||TWO_SIDED|95.0|76.3|94.9||||||||94.9|76.3|
71884773|NCT02787850|143289747|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|66.3|95.8||||||||95.8|66.3|
71884774|NCT02921971|143289756|SUPERIORITY||Least square (LS) Mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.21||0.0291|TWO_SIDED|95.0|-4.71|0.08||Above p-value is one-sided p-value. Threshold for significance is at 0.05 level.|Mixed-effect model with repeated measure|||Analysis was performed using mixed model repeated measures (MMRM) model. The model included fixed categorical effects of treatment group, randomization strata as per IVRS, timepoint, treatment-by-timepoint and strata-by-timepoint interactions, as well as the continuous fixed covariate of baseline and baseline-by-timepoint interactions.||0.08|-4.71|0.0291
71884775|NCT02322710|143289760|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 95% confidence interval of the observed difference between healing rates at D21 (Urgotul® - Tullegras M.S.®) in the PP population did not exceed +10%.|Difference in Percentages|1.2|STANDARD_DEVIATION|4.5|||ONE_SIDED|97.5||10.0||||||||10.0||
71884776|NCT04316585|143289777|SUPERIORITY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-9.19|8.28|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|Bayesian logistic regression. An informative prior was used for the placebo response in this statistical analysis, the prior for placebo response rate was of the form: 90% weight on Be (5.39, 69) and 10% on Be (1/3,1/3). The prior was derived from historical data from similar clinical trials using meta-analytic predictive prior (MAP) approach. All other parameters took vague priors.||8.28|-9.19|
71884777|NCT04316585|143289777|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-4.81|8.07|||Bayesian Logistic Regression Model|The model was adjusted for treatment (GSK2982772 vs placebo), baseline PASI score and prior biologic use (yes/no).|Posterior median and 95% CrI for the true difference in proportion of responders (GSK2982772 - placebo).|||8.07|-4.81|
71884778|NCT00130832|143289789|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.5|||<|0.001||95.0|-2.2|1.4|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 1||1.4|-2.2|<0.001
71884779|NCT00130832|143289789|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|0.0|||<|0.001||95.0|-1.4|1.6|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 2||1.6|-1.4|<0.001
71884780|NCT00130832|143289789|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers \[NA\] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.1|||<|0.001||95.0|-2.3|2.3|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers \[NA\] ≥1:8) for poliovirus type 3||2.3|-2.3|<0.001
71884781|NCT00130832|143289790|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.|GMT Ratio|0.54||||0.277||95.0|0.42|0.69|||ANOVA|ANOVA model on log titer of serum anti-rotavirus IgA||||0.69|0.42|0.277
71884782|NCT00130832|143289790|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.|Percentage Point Difference|-4.4||||0.002||95.0|-8.0|-1.4|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.|Percentage point difference (concomitant - staggered)|||-1.4|-8.0|0.002
71884783|NCT02944448|143289797|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7093|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|||||0.5|-0.4|0.7093
71884784|NCT02944448|143289798|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.6007|TWO_SIDED|95.0|-13.1|7.6|||Mixed Models Analysis|||||7.6|-13.1|0.6007
71884785|NCT02944448|143289799|SUPERIORITY||Median Difference (Final Values)|-0.8||||0.4563|TWO_SIDED|95.0|-3.0|1.4|||Mixed Models Analysis|||||1.4|-3.0|0.4563
71884786|NCT02944448|143289800|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8693|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||||0.8|-1.0|0.8693
71884787|NCT02944448|143289801|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.6516|TWO_SIDED|95.0|-9.1|5.7|||Mixed Models Analysis|||||5.7|-9.1|0.6516
71884788|NCT02944448|143289802|SUPERIORITY||Odds Ratio (OR)|0.7||||0.1033|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.1|0.5|0.1033
71884789|NCT02944448|143289803|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2831|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|Logistic regression, including treatment, baseline weekly pain score, and OA joint as independent variables.|Ratio between treatment odds of achieving a treatment response.|||1.2|0.5|0.2831
71823229|NCT02403674|143149634|SUPERIORITY|Superiority was declared when group difference (MK-1439A-ATRIPLA) was a positive value|Diff in mean % change from baseline|14.7|||||TWO_SIDED|95.0|-18.7|48.2|||||The 95% CI for mean difference in CD4 change was based on t-distribution.|||48.2|-18.7|
71884790|NCT02944448|143289804|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1959|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Logistic regression with treatment as a main effect and OA joint as a covariate.|"Ratio between treatment odds of having a PGIC of Very Much Improved or Much Improved."|||2.0|0.9|0.1959
71884791|NCT02944448|143289805|SUPERIORITY|||||||0.2858|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test stratified by Primary OA joint (Hip or Knee) and Baseline Week Mean of the Daily NRS (\<6.7 or \>=6.7) (Van Elteren test).||||||0.2858
71884792|NCT02944448|143289806|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8002|TWO_SIDED|95.0|0.3|2.7|||Regression, Logistic|Logistic regression, including treatment, baseline pain score, and OA joint as independent variables.|Ratio between treatment odds of withdrawing from treatment due to lack of analgesic efficacy.|||2.7|0.3|0.8002
71884793|NCT04681170|143289818|OTHER||Mean Difference (Net)|-53.91|||<|0.0001|TWO_SIDED|95.0|-61.859|-45.9612|||t-test, 1 sided|||This was a single-arm study, no comparative group can be assigned; the comparison made for the primary efficacy endpoint is done only between baseline and Week 24 in paediatric subjects (5 to ≤17 years of age). Analysis was made using the one-sample t-test to test the null hypothesis that the percentage change from Baseline was equal to zero against the alternative hypothesis that the percentage change from Baseline was not equal to zero.||-45.9612|-61.8590|<0.0001
71884794|NCT02118792|143289837|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71884795|NCT02787863|143289888|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
71884796|NCT02787863|143289889|OTHER||||||<|0.05|||||||McNemar|||||||<0.05
71823230|NCT02403674|143149635|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-13.0|-3.1|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-3.1|-13.0|
71823231|NCT02403674|143149636|OTHER|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-3.6|||||TWO_SIDED|95.0|-6.9|-0.5|||||95% CIs were calculated with the Miettinen \& Nurminen method.|||-0.5|-6.9|
71884797|NCT02163434|143289897|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71884798|NCT02163434|143289898|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
71884799|NCT02163434|143289899|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71884800|NCT02163434|143289901|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71884801|NCT02163434|143289902|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
71884802|NCT04283123|143289924|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.41|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
71884803|NCT04283123|143289924|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.45|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
71884804|NCT04283123|143289925|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.48|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
71884805|NCT04283123|143289925|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.32|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
71884806|NCT04283123|143289926|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.6|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the treatment group. The standardized effect size was interpreted using Cohen's criteria.|||||
71884807|NCT04283123|143289926|OTHER|Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|Cohen's d|0.12|||||TWO_SIDED||||||||Wilcoxon-signed rank test to compare differences from pretest to posttest for the waitlist control group. The standardized effect size was interpreted using Cohen's criteria.|||||
71884808|NCT03066102|143289929|OTHER|||||||0.227||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular elevation. Muscle fatigue would increase reposition error during scapular elevation. One-way repeated measures analysis of variance.||||0.227
71884809|NCT03066102|143289929|OTHER|||||||0.764||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular protraction. Muscle fatigue would increase reposition error during scapular protraction. One-way repeated measures analysis of variance.||||0.764
71884810|NCT03066102|143289930|OTHER|||||||0.413||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.413
71884811|NCT03066102|143289930|OTHER|||||||0.984||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.984
71884812|NCT03066102|143289930|OTHER|||||||0.006||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.006
71884813|NCT03066102|143289930|OTHER|||||||0.154||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.154
71884814|NCT03066102|143289930|OTHER|||||||0.096||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.096
71884815|NCT03066102|143289930|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."||||0.037
71884816|NCT03066102|143289931|OTHER|||||||8.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of serratus anterior during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.000085
71884817|NCT03066102|143289931|OTHER|||||||0.037||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of upper trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.037
71884818|NCT03066102|143289931|OTHER|||||||0.382||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of lower trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."||||0.382
71884819|NCT03066102|143289932|OTHER|||||||0.000467||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular posterior tilt during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular posterior tilt during each angle of scaption.||||0.000467
71884820|NCT03066102|143289932|OTHER|||||||0.093||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.093
71884821|NCT03066102|143289932|OTHER|||||||0.062||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.062
71884822|NCT03066102|143289932|OTHER|||||||0.04||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.04
71884823|NCT03066102|143289932|OTHER|||||||0.000147||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000147
71884824|NCT03066102|143289932|OTHER|||||||1.2e-05||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.000012
71884825|NCT03066102|143289932|OTHER|||||||0.007||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.007
71884826|NCT03066102|143289932|OTHER|||||||0.059||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.059
71884827|NCT03066102|143289932|OTHER|||||||0.032||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.032
71884828|NCT03066102|143289932|OTHER|||||||1.5e-05||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular internal rotation during scaption Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular internal rotation during each angle of scaption.||||0.000015
71884829|NCT03066102|143289932|OTHER|||||||0.296||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.296
71884830|NCT03066102|143289932|OTHER|||||||0.457||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.457
71884831|NCT03066102|143289932|OTHER|||||||0.311||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.311
71884832|NCT03066102|143289932|OTHER|||||||0.004||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.004
71884833|NCT03066102|143289932|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
71884834|NCT03066102|143289932|OTHER|||||||0.137||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.137
71884835|NCT03066102|143289932|OTHER|||||||0.636||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.636
71884836|NCT03066102|143289932|OTHER|||||||0.406||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.406
71884837|NCT03066102|143289932|OTHER|||||||0.001||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||The effects of muscle fatigue on scapular upward rotation during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular upward rotation during each angle of scaption.||||0.001
71884838|NCT03066102|143289932|OTHER|||||||0.65||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.650
71884839|NCT03066102|143289932|OTHER|||||||0.141||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.141
71884840|NCT03066102|143289932|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
71884841|NCT03066102|143289932|OTHER|||||||0.005||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.005
71884842|NCT03066102|143289932|OTHER|||||||0.083||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."||||0.083
71701105|NCT02469233|142918221|SUPERIORITY||Time by treatment interaction coeff.|-17.52||||0.02|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.02
71884843|NCT03066102|143289932|OTHER|||||||0.389||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."||||0.389
71884844|NCT03066102|143289932|OTHER|||||||0.542||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."||||0.542
71884845|NCT03066102|143289932|OTHER|||||||0.263||||||The level of statistical significance was adjusted at P\<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."||||0.263
71884846|NCT03066102|143289933|OTHER|||||||0.331||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of upper trapezius during each angle of scaption."||||0.331
71884847|NCT03066102|143289933|OTHER|||||||0.627||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of lower trapezius during each angle of scaption."||||0.627
71884848|NCT03066102|143289933|OTHER|||||||0.042||||||The level of statistical significance was set at P \< 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of serratus anterior during each angle of scaption."||||0.042
71884849|NCT03066102|143289933|OTHER|||||||0.021||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 30\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.021
71884850|NCT03066102|143289933|OTHER|||||||0.018||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 60\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.018
71884851|NCT03066102|143289933|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 90\~120 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
71884852|NCT03066102|143289933|OTHER|||||||0.002||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 120\~90 degree of scaption.~One-way repeated measures analysis of variance."||||0.002
71884853|NCT03066102|143289933|OTHER|||||||0.035||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 90\~60 degree of scaption.~One-way repeated measures analysis of variance."||||0.035
71884854|NCT03066102|143289933|OTHER|||||||0.05||||||The level of statistical significance was adjusted at P\<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 60\~30 degree of scaption.~One-way repeated measures analysis of variance."||||0.05
71884855|NCT03066102|143289934|OTHER|||||||0.5||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of upper trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.5
71884856|NCT03066102|143289934|OTHER|||||||0.843||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of lower trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.843
71884857|NCT03066102|143289934|OTHER|||||||0.466||||||The level of statistical significance was set at P \< 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of serratus anterior during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."||||0.466
71884858|NCT01926782|143289974|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-52.4|||<|0.0001|TWO_SIDED|97.5|-59.8|-45.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-45.0|-59.8|<0.0001
71884859|NCT01926782|143289974|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|97.5|-62.3|-48.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Week 21-24||-48.1|-62.3|<0.0001
71884860|NCT01926782|143289975|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-65.0|-52.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24||-52.4|-65.0|<0.0001
71884861|NCT01926782|143289975|SUPERIORITY_OR_OTHER|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-65.0|||<|0.0001|TWO_SIDED|97.5|-70.4|-59.5||Threshold for significance ≤ 0.025|Mixed Models Analysis|||Week 21-24||-59.5|-70.4|< 0.0001
71884862|NCT01926782|143289976|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.0|||<|0.0001|TWO_SIDED|97.5|-64.6|-53.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-53.4|-64.6|<0.0001
71884863|NCT01926782|143289977|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.0|||<|0.0001|TWO_SIDED|97.5|-67.7|-56.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.2|-67.7|<0.0001
71884864|NCT01926782|143289978|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.7|||<|0.0001|TWO_SIDED|97.5|-64.5|-53.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.0|-64.5|<0.0001
71884865|NCT01926782|143289979|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.3|||<|0.0001|TWO_SIDED|97.5|-62.3|-50.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.3|-62.3|<0.0001
71884866|NCT01926782|143289980|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.5|||<|0.0001|TWO_SIDED|97.5|-65.0|-54.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.1|-65.0|<0.0001
71884867|NCT01926782|143289981|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.4|||<|0.0001|TWO_SIDED|97.5|-64.8|-54.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-54.0|-64.8|<0.0001
71884868|NCT01926782|143289982|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-45.8|-33.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.1|-45.8|<0.0001
71884869|NCT01926782|143289983|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.2|||<|0.0001|TWO_SIDED|97.5|-53.2|-43.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-53.2|<0.0001
71884870|NCT01926782|143289984|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|97.5|-49.9|-39.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.1|-49.9|<0.0001
71884871|NCT01926782|143289985|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.3|||<|0.0001|TWO_SIDED|97.5|-55.0|-45.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-45.6|-55.0|<0.0001
71884872|NCT01926782|143289986|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.9|-36.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.2|-49.9|<0.0001
71884873|NCT01926782|143289987|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|97.5|-55.3|-44.8||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.8|-55.3|<0.0001
71884874|NCT01926782|143289988|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|97.5|-54.8|-43.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-54.8|<0.0001
71884875|NCT01926782|143289989|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|97.5|-57.6|-47.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.9|-57.6|<0.0001
71884876|NCT01926782|143289990|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|97.5|-36.6|-26.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.3|-36.6|<0.0001
71884877|NCT01926782|143289991|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|97.5|-38.9|-31.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.1|-38.9|<0.0001
71884878|NCT01926782|143289992|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|97.5|-49.0|-39.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.2|-49.0|<0.0001
71884879|NCT01926782|143289993|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|97.5|-49.7|-39.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.9|-49.7|<0.0001
71884880|NCT01926782|143289994|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.5|||<|0.0001|TWO_SIDED|97.5|-54.5|-44.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-54.5|<0.0001
71884881|NCT01926782|143289995|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|97.5|-52.2|-42.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.0|-52.2|<0.0001
71884882|NCT01926782|143289996|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.4|||<|0.0001|TWO_SIDED|97.5|-40.4|-32.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.4|-40.4|<0.0001
71823232|NCT02403674|143149637|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-2.5|||<|0.001|TWO_SIDED|95.0|-5.9|0.8||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Depression and suicide/self-injury difference||0.8|-5.9|<0.001
71884883|NCT01926782|143289997|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|97.5|-36.5|-29.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.1|-36.5|<0.0001
71945333|NCT00272779|143413784|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6\_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6\_5309 reported in Outcome Measure 16||||0.1833
71823233|NCT02403674|143149637|SUPERIORITY|Superiority was declared when the 1-sided p-value comparing treatment difference was \<0.02497.|Difference in percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.5|0.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Psychosis and psychotic disorders difference||0.5|-2.5|<0.001
71823234|NCT02403674|143149638|SUPERIORITY||Difference in mean %change from baseline|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.53|-6.49|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-6.49|-13.53|<0.0001
71823235|NCT02403674|143149639|SUPERIORITY||Difference in mean %change from baseline|-17.02|||<|0.0001|TWO_SIDED|95.0|-20.89|-13.16|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-13.16|-20.89|<0.0001
71823236|NCT02403674|143149640|SUPERIORITY||Difference in mean %change from baseline|-23.44|||||TWO_SIDED|95.0|-27.57|-19.32|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-19.32|-27.57|
71823237|NCT02403674|143149641|SUPERIORITY||Difference in mean %change from baseline|-35.96|||||TWO_SIDED|95.0|-47.1|-24.82|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-24.82|-47.10|
71823238|NCT02403674|143149642|SUPERIORITY||Difference in mean %change from baseline|-6.47|||||TWO_SIDED|95.0|-7.97|-4.96|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.|||-4.96|-7.97|
71823239|NCT01161160|143149669|NON_INFERIORITY|Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.|Adjusted GMT ratio|0.96|||||TWO_SIDED|95.0|0.73|1.26||||||To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.||1.26|0.73|
71823240|NCT00495469|143149751|OTHER|Tukey's trend test for dose response||||||0.003||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||||||0.003
71823241|NCT00495469|143149751|OTHER|Tukey's trend test for dose response||||||0.047||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.047
71823242|NCT00495469|143149751|OTHER|Tukey's trend test for dose response||||||0.006||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.006
71823243|NCT00495469|143149751|OTHER|Tukey's trend test for dose response||||||0.085||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05.|ANCOVA|Change=Baseline+Treatment||||||0.085
71823244|NCT00495469|143149751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.085|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.085
71823245|NCT00495469|143149751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.006|TWO_SIDED|95.0|-0.95|-0.16||Pairwise comparison included for informational purposes and not controlled for multiplicity|ANCOVA|Change=Baseline+Treatment||||-0.16|-0.95|0.006
71823246|NCT00495469|143149751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.084|TWO_SIDED|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.05|-0.73|0.084
71823247|NCT00495469|143149751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.001|TWO_SIDED|95.0|-1.05|-0.28||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.28|-1.05|0.001
71823248|NCT00495469|143149751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.97|-0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.20|-0.97|0.003
71823249|NCT00495469|143149751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.337|TWO_SIDED|95.0|-0.58|0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.20|-0.58|0.337
71823250|NCT00495469|143149753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.039|TWO_SIDED|95.0|-1.67|-0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.04|-1.67|0.039
71823251|NCT00495469|143149753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.013|TWO_SIDED|95.0|-1.89|-0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.23|-1.89|0.013
71823252|NCT00495469|143149753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.131|TWO_SIDED|95.0|-1.46|0.19||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.19|-1.46|0.131
71823253|NCT00495469|143149753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.023|TWO_SIDED|95.0|-1.77|-0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.13|-1.77|0.023
71884884|NCT01926782|143289998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|68.0|||<|0.0001|TWO_SIDED|97.5|20.9|221.0||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||221.0|20.9|<0.0001
71884885|NCT01926782|143289999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.6|||<|0.0001|TWO_SIDED|97.5|13.7|47.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||47.8|13.7|<0.0001
71884886|NCT01926782|143290000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.2|||<|0.0001|TWO_SIDED|97.5|56.7|1385.7||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1385.7|56.7|<0.0001
71884887|NCT01926782|143290001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|20.3|83.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model||83.8|20.3|<0.0001
71884888|NCT01926782|143290002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|90.6|||<|0.0001|TWO_SIDED|97.5|16.5|498.3||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||498.3|16.5|<0.0001
71884889|NCT01926782|143290003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.5|||<|0.0001|TWO_SIDED|97.5|23.4|104.4||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.||104.4|23.4|<0.0001
71884890|NCT01926782|143290004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|297.1|||<|0.0001|TWO_SIDED|97.5|27.9|3160.6||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||3160.6|27.9|<0.0001
71884891|NCT01926782|143290005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.7|||<|0.0001|TWO_SIDED|97.5|34.1|176.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.||176.8|34.1|<0.0001
71884892|NCT01926782|143290006|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.7|||<|0.0001|TWO_SIDED|97.5|-37.0|-18.3||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-18.3|-37.0|<0.0001
71884893|NCT01926782|143290007|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.1|||<|0.0001|TWO_SIDED|97.5|-35.5|-22.7||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-22.7|-35.5|<0.0001
71884894|NCT01926782|143290008|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.5|||<|0.0001|TWO_SIDED|97.5|-32.4|-14.5||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.5|-32.4|<0.0001
71884895|NCT01926782|143290009|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.6|||<|0.0001|TWO_SIDED|97.5|-32.8|-20.4||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-20.4|-32.8|<0.0001
71884896|NCT01926782|143290010|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0003|TWO_SIDED|97.5|3.1|12.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.6|3.1|0.0003
71884897|NCT01926782|143290011|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1||||0.0004|TWO_SIDED|97.5|1.9|8.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.4|1.9|0.0004
71884898|NCT01926782|143290012|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.0004|TWO_SIDED|97.5|2.6|11.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||11.1|2.6|0.0004
71884899|NCT01926782|143290013|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0007|TWO_SIDED|97.5|1.8|8.7||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.7|1.8|0.0007
71884900|NCT01926782|143290014|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.9||||0.0042|TWO_SIDED|97.5|-21.3|-2.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-2.6|-21.3|0.0042
71823254|NCT00495469|143149753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.007|TWO_SIDED|95.0|-1.95|-0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-0.32|-1.95|0.007
71884901|NCT01926782|143290015|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.1|||<|0.0001|TWO_SIDED|97.5|-21.5|-8.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-8.6|-21.5|<0.0001
71884902|NCT01926782|143290016|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1||||0.0004|TWO_SIDED|97.5|-22.9|-5.2||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.2|-22.9|0.0004
71884903|NCT01926782|143290017|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.6|||<|0.0001|TWO_SIDED|97.5|-20.3|-6.9||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-6.9|-20.3|<0.0001
71884904|NCT01926782|143290018|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6|||<|0.0001|TWO_SIDED|97.5|3.0|10.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|3.0|<0.0001
71884905|NCT01926782|143290019|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0306|TWO_SIDED|97.5|-0.1|5.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis||Alirocumab 300 mg vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.4|-0.1|0.0306
71884906|NCT03987854|143290039|SUPERIORITY||paired t-test|-7.67|STANDARD_DEVIATION|6.1|<|0.001|TWO_SIDED|||||-6.16|t-test, 2 sided|||||||<.001
71884907|NCT03987854|143290040|SUPERIORITY||paired t-test|-0.21|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|||||-3.29|t-test, 2 sided|||||||.001
71884908|NCT03987854|143290041|SUPERIORITY||paired t-test|1.92|STANDARD_DEVIATION|1.17|<|0.001|TWO_SIDED|||||7.52|t-test, 2 sided|||||||<.001
71884909|NCT03987854|143290042|SUPERIORITY||paired t-test|1.14|STANDARD_DEVIATION|1.04|<|0.001|TWO_SIDED|||||5.03|t-test, 2 sided|||||||<.001
71884910|NCT03987854|143290043|SUPERIORITY||paired t-test|2.52|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|||||6.81|t-test, 2 sided|||||||<.001
71884911|NCT03987854|143290044|SUPERIORITY||paired t-test|1.08|STANDARD_DEVIATION|1.43||0.003|TWO_SIDED|||||3.46|t-test, 2 sided|||||||.003
71884912|NCT03987854|143290045|SUPERIORITY||paired t-test|1.11|STANDARD_DEVIATION|1.56||0.004|TWO_SIDED|||||3.26|t-test, 2 sided|||||||.004
71884913|NCT03987854|143290046|SUPERIORITY||paired t-test|2.1|STANDARD_DEVIATION|2.76||0.002|TWO_SIDED|||||3.49|t-test, 2 sided|||||||.002
71884914|NCT00720109|143290093|SUPERIORITY_OR_OTHER_LEGACY||Percentage|40.7|||<|0.001|TWO_SIDED|90.0|30.8|51.4|||Chi-squared|Chi-squared test equivalent to Z-test of proportions.||The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.||51.4|30.8|<0.001
71884915|NCT00720109|143290094|SUPERIORITY_OR_OTHER_LEGACY||percentage|10.5|||=|0.13|TWO_SIDED|90.0|5.3|19.3|||Binomial Test||The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.|||19.3|5.3|=0.13
71884916|NCT06245551|143290101|OTHER|The analysis is applied to the All-subjects data.|Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-19.78|-15.25|||Mixed Models Analysis|||||-15.25|-19.78|<0.001
71884917|NCT02508194|143290107|SUPERIORITY||Vaccine efficacy|-7.1|||||TWO_SIDED|90.0|-106.9|44.3|||||The CI was estimated by an exact conditional method.|2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = (\[1 - relative risk (RR)\] \*100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (\>) 0% would demonstrate the efficacy of MEDI7510.||44.3|-106.9|
71884918|NCT06142643|143290153|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
71884919|NCT06142643|143290154|OTHER|"A responder was defined by subjects with a score 1 (very much improved), 2 (much improved) or 3 (improved) on the GAIS.~Inferential analysis for the primary evaluation criterion For the derived outcome responder rate at M1 (1 month after injection) for the GAIS Investigator, a binomial exact test (bilateral approach) vs 60% was applied for the overall score. This test compared the proportion of improvement to 60%."|||||<|0.0001||||||Power of 80%, significant result (alpha = 5%).|t-test, 2 sided|Null hypothesis stated that less than 60% of subjects were responders with GAIS. Under the alternative hypothesis, 75% of subjects were responders.||||||<0.0001
71884920|NCT03485820|143290162|SUPERIORITY||Mean Difference (Net)|1.3||||0.76|TWO_SIDED|95.0|-7.1|9.6||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||9.6|-7.1|0.76
71823255|NCT00495469|143149753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.223|TWO_SIDED|95.0|-1.34|0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||0.32|-1.34|0.223
71884921|NCT03485820|143290163|SUPERIORITY||Mean Difference (Net)|-1.8||||0.6|TWO_SIDED|95.0|-8.6|5.0||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||5.0|-8.6|0.60
71884922|NCT03485820|143290164|SUPERIORITY||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.06|0.05||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.05|-0.06|0.83
71884923|NCT03485820|143290165|SUPERIORITY||Mean Difference (Net)|0.39||||0.046|TWO_SIDED|95.0|0.01|0.77||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression , number of days in inpatient rehabilitation, and baseline calendar time.||0.77|0.01|0.046
71884924|NCT03485820|143290166|SUPERIORITY||Mean Difference (Net)|0.52||||0.02|TWO_SIDED|95.0|0.08|0.96||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.96|0.08|0.02
71884925|NCT03485820|143290167|SUPERIORITY||Mean Difference (Net)|-10.6||||0.07|TWO_SIDED|95.0|-21.9|0.8||P value shown is for group by time interaction.|Mixed Models Analysis||Between group differences in changes over time (COMPASS vs Education program)|A linear mixed effects model was used to assess the effects of time, group and the interaction of group and time on the outcome. A significant interaction of group and time would indicate that the two groups had significantly different changes in the outcome over time. The model adjusted for race, marital status, living situation, depression, number of days in inpatient rehabilitation, and baseline calendar time.||0.8|-21.9|0.07
71884926|NCT04685876|143290168|SUPERIORITY|||||||0.355|||||||Regression, Linear|||||||0.355
71884927|NCT04685876|143290168|SUPERIORITY|||||||0.578|||||||Regression, Linear|||||||0.578
71884928|NCT04685876|143290170|SUPERIORITY|||||||0.248|||||||Regression, Cox|||||||0.248
71884929|NCT04685876|143290170|SUPERIORITY|||||||0.297|||||||Regression, Cox|||||||0.297
71823256|NCT00495469|143149754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.1||||0.005|TWO_SIDED|95.0|-40.9|-7.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-7.4|-40.9|0.005
71884930|NCT04685876|143290171|SUPERIORITY|||||||0.748|||||||Mixed Models Analysis|||||||0.748
71884931|NCT04685876|143290171|SUPERIORITY|||||||0.395|||||||Mixed Models Analysis|||||||0.395
71884932|NCT04685876|143290172|SUPERIORITY|||||||0.152|||||||Regression, Linear|||||||0.152
71884933|NCT04685876|143290172|SUPERIORITY|||||||0.482|||||||Regression, Linear|||||||0.482
71884934|NCT01358864|143290173|SUPERIORITY_OR_OTHER||Adjusted percent difference|52.8|||<|0.0001|TWO_SIDED|95.0|42.4|63.2||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||63.2|42.4|<0.0001
71884935|NCT01358864|143290173|SUPERIORITY_OR_OTHER||Adjusted percent difference|48.5|||<|0.0001|TWO_SIDED|95.0|38.2|58.9||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||58.9|38.2|<0.0001
71884936|NCT01358864|143290173|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.4|||||TWO_SIDED|95.0|-6.0|14.9||||||||14.9|-6.0|
71884937|NCT01358864|143290173|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
71884938|NCT01358864|143290173|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
71884939|NCT01358864|143290173|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
71884940|NCT01358864|143290175|SUPERIORITY_OR_OTHER||Adjusted percent difference|54.7|||<|0.0001|TWO_SIDED|95.0|44.4|65.0||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||65.0|44.4|<0.0001
71884941|NCT01358864|143290175|SUPERIORITY_OR_OTHER||Adjusted percent difference|50.4|||<|0.0001|TWO_SIDED|95.0|40.1|60.8||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel|||||60.8|40.1|<0.0001
71884942|NCT01358864|143290175|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.5|||||TWO_SIDED|95.0|-5.8|14.9||||||||14.9|-5.8|
71884943|NCT01358864|143290175|SUPERIORITY_OR_OTHER||Adjusted percent difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.7||||||||10.7|-10.9|
71884944|NCT01358864|143290175|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.||||<0.0001
71884945|NCT01358864|143290175|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.||||0.0001
71884946|NCT03194373|143290186|SUPERIORITY|Power to detect a 20% improvement in disease control rate (DCR). Based on historical data, the DCR in R/M HNSCC with single agent platinum therapy is 40%. We hypothesize that addition of Palbociclib will increase DCR at 12 weeks to 60%. Two-stage design. Type I error rate of 0.059 and power of 0.80 when the true response rate is 0.60 with alpha=0.05. The two-stage sample size calculations assume a null probability of 0.40.|Proportion|33.0|||||TWO_SIDED|95.0|13.0|59.0||||||||59|13|
71884947|NCT03194373|143290187|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
71884948|NCT03194373|143290188|OTHER||||||||||||||||||Median survival times were computed using the Kaplan-Meier method with standard error computed using Greenwood's formula. All analyses were done using SAS 9.4 software.|||
71884949|NCT02177201|143290190|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: The antiemetic effect was not significantly different for two groups in this study||||0.05
71884950|NCT02177201|143290190|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared, Corrected|||77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.||||<0.05
71884951|NCT04209855|143290255|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.513|0.785|||Log Rank|||||0.785|0.513|<0.0001
71884952|NCT01250379|143290271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0204|TWO_SIDED|95.0|0.65|0.97|||Log Rank||The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.|||0.97|0.65|0.0204
71884953|NCT01250379|143290271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0245|TWO_SIDED|95.0|0.67|0.97|||Log Rank||Unstratified analysis.|||0.97|0.67|0.0245
71884954|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0088|TWO_SIDED|95.0|0.4|0.88|||Log Rank|||Subgroup analysis: HR-neg||0.88|0.40|0.0088
71823257|NCT00495469|143149754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.0|||<|0.001|TWO_SIDED|95.0|-52.5|-17.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-17.4|-52.5|<0.001
71884955|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1196|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||Subgroup analysis: HR-pos/HER-neg||1.05|0.67|0.1196
71884956|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.011|TWO_SIDED|95.0|0.43|0.9|||Log Rank|||Subgroup analysis: PFS \<6 months||0.90|0.43|0.0110
71884957|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0816|TWO_SIDED|95.0|0.65|1.03|||Log Rank|||Subgroup analysis: PFS ≥6 months||1.03|0.65|0.0816
71884958|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.0395|TWO_SIDED|95.0|0.31|0.98|||Log Rank|||Subgroup analysis: taxane chemo||0.98|0.31|0.0395
71884959|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.1385|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||Subgroup analysis: non-taxane chemo||1.06|0.68|0.1385
71884960|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.0029|TWO_SIDED|95.0|0.22|0.75|||Log Rank|||Subgroup analysis: vinorelbine chemo||0.75|0.22|0.0029
71884961|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0171|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||Subgroup analysis: LDH ≤ 1.5 ULN||0.96|0.62|0.0171
71884962|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1797|TWO_SIDED|95.0|0.46|1.16|||Log Rank|||Subgroup analysis: LDH \> 1.5 ULN||1.16|0.46|0.1797
71884963|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0229|TWO_SIDED|95.0|0.62|0.97|||Log Rank|||Subgroup analysis: \< 65 years of age||0.97|0.62|0.0229
71884964|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.2139|TWO_SIDED|95.0|0.51|1.16|||Log Rank|||Subgroup analysis: ≥ 65 years of age||1.16|0.51|0.2139
71884965|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0021|TWO_SIDED|95.0|0.59|0.89|||Log Rank|||Subgroup analysis: \< 70 years of age||0.89|0.59|0.0021
71884966|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.5216|TWO_SIDED|95.0|0.64|2.39|||Log Rank|||Subgroup analysis: ≥ 70 years of age||2.39|0.64|0.5216
71884967|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0148|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||Subgroup analysis: \< 3 metastatic organ sites||0.94|0.58|0.0148
71884968|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3102|TWO_SIDED|95.0|0.61|1.17|||Log Rank|||Subgroup analysis: ≥ 3 metastatic organ sites||1.17|0.61|0.3102
71884969|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0967|TWO_SIDED|95.0|0.64|1.04|||Log Rank|||Subgroup analysis: B-free ≤ 6 weeks||1.04|0.64|0.0967
71884970|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0489|TWO_SIDED|95.0|0.51|1.0|||Log Rank|||Subgroup analysis: B-free \> 6 weeks||1.00|0.51|0.0489
71884971|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0176|TWO_SIDED|95.0|0.41|0.92|||Log Rank|||Subgroup analysis: D-free ≤ 24 months||0.92|0.41|0.0176
71884972|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2318|TWO_SIDED|95.0|0.66|1.11|||Log Rank|||Subgroup analysis: D-free \> 24 months||1.11|0.66|0.2318
71884973|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0568|TWO_SIDED|95.0|0.26|1.03|||Log Rank|||Subgroup analysis: D-free ≤ 12 months||1.03|0.26|0.0568
71884974|NCT01250379|143290272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1143|TWO_SIDED|95.0|0.66|1.05|||Log Rank|||Subgroup analysis: D-free \> 12 months||1.05|0.66|0.1143
71884975|NCT01250379|143290273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.3457|TWO_SIDED|95.0|-4.2|12.4|||Chi-squared||The 95% CI was estimated using Hauck-Anderson methodology.|||12.4|-4.2|0.3457
71884976|NCT01250379|143290275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9825|TWO_SIDED|95.0|0.51|1.99|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.99|0.51|0.9825
71884977|NCT01250379|143290275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.3601|TWO_SIDED|95.0|0.73|2.34|||Log Rank||Unstratified analysis.|||2.34|0.73|0.3601
71884978|NCT01250379|143290278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.108|TWO_SIDED|95.0|0.59|1.06|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.06|0.59|0.1080
71884979|NCT01250379|143290278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0625|TWO_SIDED|95.0|0.59|1.02|||Log Rank||Unstratified analysis.|||1.02|0.59|0.0625
71884980|NCT01250379|143290280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1349|TWO_SIDED|95.0|0.68|1.05|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.05|0.68|0.1349
71884981|NCT01250379|143290280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0863|TWO_SIDED|95.0|0.68|1.03|||Log Rank||Unstratified analysis.|||1.03|0.68|0.0863
71884982|NCT01250379|143290282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0744|TWO_SIDED|95.0|0.65|1.02|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.02|0.65|0.0744
71884983|NCT01250379|143290282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0503|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Unstratified analysis.|||1.00|0.66|0.0503
71884984|NCT01250379|143290285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7253|TWO_SIDED|95.0|0.76|1.21|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.|||1.21|0.76|0.7253
71884985|NCT01250379|143290285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5332|TWO_SIDED|95.0|0.75|1.16|||Log Rank||Unstratified analysis.|||1.16|0.75|0.5332
71945334|NCT00272779|143413785|SUPERIORITY_OR_OTHER|||||||0.1833||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_097 reported in Outcome Measure 16.||||0.1833
71945335|NCT00272779|143413786|SUPERIORITY_OR_OTHER|||||||0.1694||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122\_5980 reported in Outcome Measure 16.||||0.1694
71884986|NCT01327157|143290336|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors.|Mean Difference (Net)|0.5||||0.524|TWO_SIDED|||||Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results.|t-test, 1 sided|The comparison between the groups in each study period (initial) was done through the t-test for two independent samples.||"We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p \<0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results"||||0.524
71884987|NCT01327157|143290337|EQUIVALENCE|"Only the treatment group was analysed. The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.~The models are made in the first and last query, after four visits with one month interval between them."|Mean Difference (Net)|5.0|STANDARD_DEVIATION|3.92|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The brand carbon mark was done on the treatment group in the first and last query.||||<0.001
71884988|NCT01327157|143290338|EQUIVALENCE|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors. The comparison among the groups, in each period of the study (initial and final) was done through t test for two independent samples.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|1.44||0.002|TWO_SIDED||||||t-test, 2 sided|||"We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p\<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results."||||0.002
71884989|NCT01327157|143290339|OTHER|||||||0.705|||||||t-test, 1 sided|||||||0.705
71884990|NCT01327157|143290340|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
71884991|NCT04526665|143290348|OTHER||Odds Ratio (OR)|37.562|||<|0.0001|TWO_SIDED|95.0|7.641|302.247|||Exact Cochran-Mantel-Haenszel test|Exact Cochran-Mantel-Haenszel test stratified by the randomization factors (ALP \>3xULN or TB\>ULN:Yes/No, and Baseline PBC Worst Itch NRS ≥ 4: Yes/No)||||302.247|7.641|<0.0001
71884992|NCT04526665|143290350|OTHER||Least square mean difference|-0.784||||0.197|TWO_SIDED|95.0|-1.986|0.418|||mixed model for repeated measures (MMRM)|||||0.418|-1.986|0.1970
71884993|NCT04526665|143290351|OTHER||Least square mean difference|-0.343||||0.5522|TWO_SIDED|95.0|-1.489|0.803|||MMRM|MMRM with treatment, 4-week period and treatment by 4-week period interaction as fixed factors and adjusting for baseline and stratification factors.||||0.803|-1.489|0.5522
71884994|NCT04647253|143290403|SUPERIORITY||Rate difference between treatment groups|-10.8||||0.0025|TWO_SIDED|95.0|-18.4|-3.3||a priori threshold for statistical significance was 0.025|z-test with unpooled variance|||||-3.3|-18.4|0.0025
71884995|NCT03118297|143290473|SUPERIORITY|||||||0.002||||||Threshold for significance: p=0.05|Wilcoxon (Mann-Whitney)|||||||0.002
71884996|NCT03118297|143290474|SUPERIORITY|||||||0.032||||||Threshold for significance: p=0.05|Fisher Exact|||||||0.032
71884997|NCT03118297|143290475|SUPERIORITY||||||<|0.001||||||Threshold for significance: p=0.05|Fisher Exact|||||||<0.001
71884998|NCT03118297|143290476|SUPERIORITY||||||>|0.05||||||Threshold for significance: p=0.05|Chi-squared|||||||>0.05
71884999|NCT03118297|143290477|OTHER|No statistical test performed|||||||||||||||||Significance testing not performed. All values below prespecified limit of 5.0 ng/mL.|||
71885000|NCT02479802|143290478|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||<0.0001
71885001|NCT02479802|143290479|OTHER|||||||0.0006|||||||t-test, 1 sided|||Change from Baseline at Week 48.||||0.0006
71885002|NCT01978093|143290484|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-2.12|4.3|||Group difference in proportions|Before concluding on the primary objectives for Rotarix, Prevnar 13 and Havrix, this primary objective regarding anti-PRP needs to be reached||Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.||4.30|-2.12|
71885003|NCT01978093|143290485|NON_INFERIORITY|Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5|Adjusted GMC ratios|1.21|||||TWO_SIDED|97.5|0.77|1.9|||ANCOVA|GMC adjusted for BS sub-cohorts;97.5% confidence interval calculated for adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 Post dose 3)\& Epoch 002 (Havrix \& Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 \& 002)|GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine||1.90|0.77|
71885004|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio (Ancova Model: adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.||1.47|0.95|
71885005|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.15|||||TWO_SIDED|97.5|0.93|1.42|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.||1.42|0.93|
71885006|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.08|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.||1.31|0.90|
71885007|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.95|1.47|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.||1.47|0.95|
71885008|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.29|||||TWO_SIDED|97.5|1.03|1.63|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.||1.63|1.03|
71885009|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.17|||||TWO_SIDED|97.5|0.88|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.||1.55|0.88|
71885010|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.11|||||TWO_SIDED|97.5|0.91|1.34|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.||1.34|0.91|
71885011|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.0|1.55|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.||1.55|1.00|
71885012|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.9|1.5|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.||1.50|0.90|
71885013|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.24|||||TWO_SIDED|97.5|1.01|1.52|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.||1.52|1.01|
71885014|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.94|1.43|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.||1.43|0.94|
71885015|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.07|||||TWO_SIDED|97.5|0.89|1.29|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.||1.29|0.89|
71885016|NCT01978093|143290486|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||TWO_SIDED|97.5|0.91|1.53|||ANCOVA|GMC adjusted for BS subcohorts;97.5% CI for the adjusted GMC ratio(Ancova model:adjustment for BS subcohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix\&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.||1.53|0.91|
71885017|NCT01978093|143290487|NON_INFERIORITY|Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.0|||||TWO_SIDED|97.5|-3.76|3.91|||Group difference in proportions||To be able to conclude independently on primary objectives of Epoch 001(Rotarix \& Prevnar13 post dose 3)\& Epoch 002(Havrix \& Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 \& Epoch 002)|Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.||3.91|-3.76|
71885018|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||TWO_SIDED|97.5|1.04|1.51|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose||1.51|1.04|
71885019|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.01|||||TWO_SIDED|97.5|0.83|1.24|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose||1.24|0.83|
71885020|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.1|||||TWO_SIDED|97.5|0.92|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose||1.31|0.92|
71885021|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.06|||||TWO_SIDED|97.5|0.87|1.28|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose||1.28|0.87|
71885022|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.21|||||TWO_SIDED|97.5|1.01|1.44|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose||1.44|1.01|
71885023|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.13|||||TWO_SIDED|97.5|0.94|1.36|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose||1.36|0.94|
71885024|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.93|1.29|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose||1.29|0.93|
71885025|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.94|1.33|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose||1.33|0.94|
71885026|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.96|1.41|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose||1.41|0.96|
71885027|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.14|||||TWO_SIDED|97.5|0.97|1.35|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose||1.35|0.97|
71885028|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||TWO_SIDED|97.5|0.9|1.31|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose||1.31|0.90|
71885029|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||TWO_SIDED|97.5|0.95|1.34|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose||1.34|0.95|
71885030|NCT01978093|143290488|NON_INFERIORITY|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.22|||||TWO_SIDED|97.5|1.0|1.5|||ANCOVA|GMC adjusted for BS sub cohorts;97.5% CI for adjusted GMC ratio(Ancova model:adjustment for BS sub cohorts-pooled variance)|To be able to conclude independently on primary objectives of Epoch 001 \& Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose||1.50|1.00|
71885031|NCT02469090|143290505|SUPERIORITY||LS mean differnce|-7.6|STANDARD_ERROR_OF_MEAN|1.96||0.0002|TWO_SIDED|95.0|-11.5|-3.7||The null-hypothesis to be tested was: H0: APL-130277 is the same as placebo in its effect on the motor function against the 2-sided alternative: H1: Either of the treatment groups is superior to the other in its effect on the motor function.|LS mean difference|To control the family-wise type I error rate, the primary and secondary end points were tested in hierarchical order in the order presented||Mixed effects model for repeated measures (MMRM) was used to estimate the treatment difference(APL-130277-placebo) Observed change from pre-dose MDS-UPDRS Part III score values after 30 minutes were response values. Treatment group, visit and the interaction between the treatment group and visit were fixed factors. Change from pre-dose in MDS-UPDRS Part III score after 30 minutes at the last TV at which the randomized dose was given up through TV6 was used as a covariate||-3.7|-11.5|0.0002
71885032|NCT02469090|143290506|SUPERIORITY||Adjusted odds ratio|2.81||||0.0426|TWO_SIDED|95.0|1.036|7.644|||Adjusted Odds Ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.644|1.036|0.0426
71885033|NCT02469090|143290507|SUPERIORITY||Adjusted odds ratio|2.8||||0.0501|TWO_SIDED|95.0|1.0|7.84||The hierarchical testing stopped at this endpoint due to non-significant result. P-values for endpoints after this endpoint have not been presented and the confidence interval presented are unadjusted for multiplicity.|Adjusted odds ratio|||"This was analyzed using a generalized linear mixed model (with logit link function) for binomial data. The model included the observed outcomes as the response values, with treatment group, visit, and the interaction between treatment group and visit as fixed factors and the ON/OFF assessment at the last open-label titration visit at which the randomized dose was given as a covariate."||7.84|1.00|0.0501
71885034|NCT02469090|143290510|SUPERIORITY||LS mean difference|-1.1|||||TWO_SIDED|95.0|-3.159|0.959||||||||0.959|-3.159|
71885035|NCT02469090|143290511|SUPERIORITY||LS mean difference|47.6|||||TWO_SIDED|95.0|28.84|66.36||||||||66.36|28.84|
71885036|NCT02469090|143290512|SUPERIORITY||LS mean difference|1.979|||||TWO_SIDED|95.0|-2.162|6.12||||||||6.120|-2.162|
71885037|NCT02469090|143290513|SUPERIORITY||LS mean difference|-3.4|||||TWO_SIDED|95.0|-6.7|-0.2||||||||-0.2|-6.7|
71885038|NCT02469090|143290514|SUPERIORITY||Hazard ratio|3.4|||||TWO_SIDED|95.0|1.99|5.69||||||Median Time to effect for APL-130277 versus placebo patients||5.69|1.99|
71885039|NCT01202656|143290550|SUPERIORITY_OR_OTHER|||||||0.72|||||||Cochran-Mantel-Haenszel|||||||0.72
71885040|NCT01496066|143290556|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
71885041|NCT01496066|143290557|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71885042|NCT01496066|143290558|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71885043|NCT01496066|143290559|SUPERIORITY|||||||0.0318|||||||t-test, 2 sided|||||||.0318
71885044|NCT01496066|143290560|EQUIVALENCE|a two-group t-test of equivalence in means was used|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|99.0|-0.06|-0.02||||||||-0.02|-0.06|
71885045|NCT00355394|143290565|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
71885046|NCT00355394|143290566|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71885047|NCT00355394|143290567|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
71885048|NCT00355394|143290568|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71885049|NCT00355394|143290569|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
71885050|NCT00355394|143290570|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.50
71885051|NCT00411554|143290581|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent|Least-squares Mean Difference|-0.39|||<|0.001||95.0|-0.51|-0.28||"This p-value corresponds to a test of superiority that was performed after success was achieved in the test of non-inferiority (reported under Estimation below), according to the pre-specified analysis plan"|ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show non-inferiority and superiority to voglibose (closed procedure) and to estimate difference of two groups and its 95% confidence interval|||-0.28|-0.51|<0.001
71885052|NCT00411554|143290582|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-10.7|||<|0.001||95.0|-15.3|-6.2|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-6.2|-15.3|<0.001
71885053|NCT00411554|143290583|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-18.8|||<|0.001||95.0|-26.7|-10.9|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval|||-10.9|-26.7|<0.001
71885054|NCT00699907|143290584|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon Rank Sum Test|||||||0.012
71885055|NCT00699907|143290584|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
71885056|NCT00699907|143290585|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
71885057|NCT00699907|143290585|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
71885058|NCT00699907|143290586|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon Rank Sum Test|||||||0.0006
71885059|NCT00699907|143290586|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
71885060|NCT00699907|143290587|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Rank Sum Test|||||||0.009
71885061|NCT00699907|143290587|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
71885062|NCT00699907|143290588|SUPERIORITY_OR_OTHER|||||||0.037|||||||Wilcoxon Rank Sum Test|||||||0.037
71885063|NCT00699907|143290588|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
71885064|NCT00699907|143290589|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon Rank Sum Test|||||||0.010
71885065|NCT00699907|143290589|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
71885066|NCT00699907|143290590|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
71885067|NCT00699907|143290590|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Rank Sum Test|||||||>0.05
71885068|NCT00699907|143290591|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon Rank Sum Test|||||||0.006
71885069|NCT00699907|143290591|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
71885070|NCT00699907|143290592|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
71885071|NCT00699907|143290592|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon Rank Sum Test|||||||0.005
71885072|NCT02161211|143290593|SUPERIORITY|||||||0.673|||||||Chi-squared|df = 2||Null hypothesis = no difference in frequency in relapse between groups||||.673
71885073|NCT02161211|143290594|SUPERIORITY||Wald Chi-squared|-0.278||||0.133|TWO_SIDED|95.0|-0.64|0.084|||Wald Chi-squared|Negative binomial regression with offset of natural log of possible drinking days||||.084|-.64|.133
71885074|NCT02161211|143290594|SUPERIORITY||Wald Chi-squared|0.101||||0.562|TWO_SIDED|95.0|-0.24|0.44|||Wald Chi-squared|||||.44|-.24|.562
71885075|NCT02161211|143290595|SUPERIORITY|||||||0.982|||||||ANOVA|F(2,105) = .019||||||.982
71885076|NCT02161211|143290596|SUPERIORITY|||||||0.685|||||||Chi-squared|||Null hypothesis = no difference in proportion between the groups||||.685
71885077|NCT02161211|143290597|SUPERIORITY|||||||0.608|||||||Chi-squared|||Null hypothesis = no significant difference in frequency of hazardous drinking between groups||||.608
71885078|NCT00430508|143290598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.3|||<|0.0001||95.0|-6.97|-3.6|||ANCOVA|||||-3.6|-6.97|<0.0001
71885079|NCT00430508|143290598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.0001||95.0|-4.79|-2.03|||ANCOVA|||||-2.03|-4.79|<0.0001
71885080|NCT00430508|143290598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1788||95.0|-2.32|0.43|||ANCOVA|||||0.43|-2.32|0.1788
71885081|NCT00430508|143290599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001||95.0|-5.54|-2.6|||ANCOVA|||||-2.6|-5.54|<0.0001
71885082|NCT00430508|143290599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.39|-1.98|||ANCOVA|||||-1.98|-4.39|<0.0001
71885083|NCT00430508|143290599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1081||95.0|-2.19|0.22|||ANCOVA|||||0.22|-2.19|0.1081
71885084|NCT00430508|143290600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|||<|0.0001||95.0|-10.13|-4.66|||ANCOVA|||||-4.66|-10.13|<0.0001
71885085|NCT00430508|143290600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|||<|0.0001||95.0|-7.4|-2.91|||ANCOVA|||||-2.91|-7.4|<0.0001
71885086|NCT00430508|143290600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0255||95.0|-4.79|-0.31|||ANCOVA|||||-0.31|-4.79|0.0255
71885087|NCT00430508|143290601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.6|||<|0.0001||95.0|-9.0|-4.26|||ANCOVA|||||-4.26|-9.00|<0.0001
71885088|NCT00430508|143290601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||<|0.0001||95.0|-6.7|-2.81|||ANCOVA|||||-2.81|-6.70|<0.0001
71885089|NCT00430508|143290601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0812||95.0|-3.66|0.21|||ANCOVA|||||0.21|-3.66|0.0812
71885090|NCT00430508|143290602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||||95.0|1.69|4.21|||Regression, Logistic|||||4.21|1.69|
71885091|NCT00430508|143290602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||||95.0|1.5|3.24|||Regression, Logistic|||||3.24|1.50|
71885092|NCT00430508|143290602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||||95.0|1.07|2.25|||Regression, Logistic|||||2.25|1.07|
71885093|NCT00430508|143290603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|||<|0.0001||95.0|-6.78|-3.36|||ANCOVA|||||-3.36|-6.78|<0.0001
71885094|NCT00430508|143290603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.54|-1.78|||ANCOVA|||||-1.78|-4.54|<0.0001
71885095|NCT00430508|143290603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1452||95.0|-2.43|0.36|||ANCOVA|||||0.36|-2.43|0.1452
71885096|NCT00430508|143290604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.0001||95.0|-6.79|-3.17|||ANCOVA|||||-3.17|-6.79|<0.0001
71885097|NCT00430508|143290604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|||<|0.0001||95.0|-4.79|-1.87|||ANCOVA|||||-1.87|-4.79|<0.0001
71885098|NCT00430508|143290604|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1629||95.0|-2.52|0.42|||ANCOVA|||||0.42|-2.52|0.1629
71885099|NCT00430508|143290605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|||<|0.0001||95.0|-7.4|-3.62|||ANCOVA|||||-3.62|-7.40|<0.0001
71885100|NCT00430508|143290605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.0009||95.0|-4.12|-1.07|||ANCOVA|||||-1.07|-4.12|<0.0009
71885101|NCT00430508|143290605|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.1985||95.0|-2.55|0.53|||ANCOVA|||||0.53|-2.55|0.1985
71885102|NCT03138876|143290611|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71885103|NCT04673786|143290615|EQUIVALENCE|Predefined equivalence margin: -10% to 10%|Treatment difference (%) and 90% CI|2.05|||||TWO_SIDED|90.0|-0.23|4.32|||ANCOVA|Multiple imputation (MI) with the Missing at random (MAR) assumption was applied.||||4.32|-0.23|
71885104|NCT03850912|143290627|SUPERIORITY||Odds Ratio (OR)|1.104||||0.214|TWO_SIDED|95.0|0.944|1.29|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (chemo and surgical patients combined)||1.290|0.944|0.214
71885105|NCT03850912|143290627|SUPERIORITY||Odds Ratio (OR)|0.927||||0.565|TWO_SIDED|95.0|0.715|1.201|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.201|0.715|0.565
71885106|NCT03850912|143290627|SUPERIORITY||Odds Ratio (OR)|1.225||||0.042|TWO_SIDED|95.0|1.008|1.49|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.490|1.008|0.042
71885107|NCT03850912|143290628|OTHER||Odds Ratio (OR)|1.128||||0.05|TWO_SIDED|95.0|1.0|1.272|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.272|1.000|0.050
71885108|NCT03850912|143290628|OTHER||Odds Ratio (OR)|1.012||||0.903|TWO_SIDED|95.0|0.836|1.225|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.225|0.836|0.903
71885109|NCT03850912|143290628|OTHER||Odds Ratio (OR)|1.215||||0.014|TWO_SIDED|95.0|1.04|1.418|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.418|1.040|0.014
71885110|NCT03850912|143290629|OTHER||Odds Ratio (OR)|1.002||||0.978|TWO_SIDED|95.0|0.881|1.139|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.139|0.881|0.978
71885111|NCT03850912|143290629|OTHER||Odds Ratio (OR)|0.854||||0.126|TWO_SIDED|95.0|0.697|1.046|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.046|0.697|0.126
71885112|NCT03850912|143290629|OTHER||Odds Ratio (OR)|1.102||||0.254|TWO_SIDED|95.0|0.933|1.302|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.302|0.933|0.254
71885113|NCT03850912|143290630|OTHER||Odds Ratio (OR)|1.068||||0.209|TWO_SIDED|95.0|0.964|1.183|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology and surgical patients combined)||1.183|0.964|0.209
71885114|NCT03850912|143290630|OTHER||Odds Ratio (OR)|0.992||||0.924|TWO_SIDED|95.0|0.85|1.159|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (medical oncology patients only)||1.159|0.850|0.924
71885115|NCT03850912|143290630|OTHER||Odds Ratio (OR)|1.122||||0.099|TWO_SIDED|95.0|0.979|1.286|||Regression, Logistic|||Adjusted analysis comparing control versus intervention patients (surgical patients only)||1.286|0.979|0.099
71885116|NCT03850912|143290631|SUPERIORITY||Difference|-1.328||||0.04|TWO_SIDED|95.0|-2.593|-0.062|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||-0.062|-2.593|0.04
71885117|NCT03850912|143290631|OTHER||Difference|-1.958||||0.004|TWO_SIDED|95.0|-3.269|-0.646|||Regression, Logistic|||Multivariable regression analyses (surgical cohort only)||-0.646|-3.269|0.004
71885118|NCT03850912|143290632|SUPERIORITY||Difference|-0.925||||0.09|TWO_SIDED|95.0|-1.985|0.136|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.136|-1.985|0.09
71885119|NCT03850912|143290632|SUPERIORITY||Difference|-1.516||||0.002|TWO_SIDED|95.0|-2.474|-0.557|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-0.557|-2.474|0.002
71885120|NCT03850912|143290633|SUPERIORITY||Difference|-1.767||||0.17|TWO_SIDED|95.0|-2.532|0.433|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.433|-2.532|0.17
71885121|NCT03850912|143290633|SUPERIORITY||Difference|-2.198|||<|0.0001|TWO_SIDED|95.0|-3.259|-1.137|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||-1.137|-3.259|<0.0001
71885122|NCT03850912|143290634|SUPERIORITY||Difference|-0.8084||||0.2|TWO_SIDED|95.0|-2.048|0.431|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.431|-2.048|0.2
71885123|NCT03850912|143290634|SUPERIORITY||Difference|-0.652||||0.27|TWO_SIDED|95.0|-1.8|0.496|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.496|-1.800|0.27
71885124|NCT03850912|143290635|SUPERIORITY||Difference|-0.617||||0.23|TWO_SIDED|95.0|-1.62|0.386|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.386|-1.620|0.23
71885125|NCT03850912|143290635|SUPERIORITY||Difference|0.434||||0.39|TWO_SIDED|95.0|-0.563|1.431|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||1.431|-0.563|0.39
71885126|NCT03850912|143290636|SUPERIORITY||Difference|-0.7||||0.22|TWO_SIDED|95.0|-1.829|0.429|||Regression, Linear|||Multivariable regression analyses (medical oncology cohort only)||0.429|-1.829|0.22
71885127|NCT03850912|143290636|SUPERIORITY||Difference|-0.58||||0.28|TWO_SIDED|95.0|-1.632|0.472|||Regression, Linear|||Multivariable regression analyses (surgical cohort only)||0.472|-1.632|0.28
71885128|NCT03850912|143290637|SUPERIORITY||Odds Ratio (OR)|0.842|||<|0.001|TWO_SIDED|95.0|0.776|0.913|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (chemo and surgical patients combined)||0.913|0.776|<0.001
71885129|NCT03850912|143290637|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.001|TWO_SIDED|95.0|0.688|0.885|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.885|0.688|<0.001
71885130|NCT03850912|143290637|SUPERIORITY||Odds Ratio (OR)|0.889||||0.032|TWO_SIDED|95.0|0.799|0.99|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.990|0.799|0.032
71885131|NCT03850912|143290638|SUPERIORITY||Odds Ratio (OR)|0.893|||<|0.001|TWO_SIDED|95.0|0.839|0.949|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.949|0.839|<0.001
71885132|NCT03850912|143290638|SUPERIORITY||Odds Ratio (OR)|0.872||||0.003|TWO_SIDED|95.0|0.796|0.954|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.954|0.796|0.003
71885133|NCT03850912|143290638|SUPERIORITY||Odds Ratio (OR)|0.909||||0.027|TWO_SIDED|95.0|0.835|0.989|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.989|0.835|0.027
71885134|NCT03850912|143290639|SUPERIORITY||Odds Ratio (OR)|0.636|||<|0.001|TWO_SIDED|95.0|0.593|0.682|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.682|0.593|<0.001
71885135|NCT03850912|143290639|SUPERIORITY||Odds Ratio (OR)|0.611|||<|0.001|TWO_SIDED|95.0|0.55|0.679|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.679|0.550|<0.001
71885136|NCT03850912|143290639|SUPERIORITY||Odds Ratio (OR)|0.655|||<|0.001|TWO_SIDED|95.0|0.597|0.719|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.719|0.597|<0.001
71885137|NCT03850912|143290640|SUPERIORITY||Odds Ratio (OR)|0.769|||<|0.001|TWO_SIDED|95.0|0.729|0.811|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology and surgical patients combined)||0.811|0.729|<0.001
71885138|NCT03850912|143290640|SUPERIORITY||Odds Ratio (OR)|0.795|||<|0.001|TWO_SIDED|95.0|0.737|0.858|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (medical oncology patients only)||0.858|0.737|<0.001
71885139|NCT03850912|143290640|SUPERIORITY||Odds Ratio (OR)|0.739|||<|0.001|TWO_SIDED|95.0|0.686|0.796|||Regression, Logistic|||Adjusted analysis comparing intervention responders versus non-responders (surgical patients only)||0.796|0.686|<0.001
71885140|NCT02189850|143290666|SUPERIORITY|||||||0.923|||||||Cochran-Mantel-Haenszel|||||||0.923
71885141|NCT01844895|143290675|SUPERIORITY_OR_OTHER||geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||A mixed-effect model of log (Cminss) with device and substudy baseline weight category (\< 60 kg,60-100 kg, \> 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.||1.00|0.83|
71885142|NCT00511355|143290687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0849||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0849
71885143|NCT00511355|143290689|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885144|NCT00511355|143290690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4191||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.4191
71823258|NCT00495469|143149754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.8||||0.001|TWO_SIDED|95.0|-46.9|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.9|0.001
71885145|NCT00511355|143290691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0010
71885146|NCT00511355|143290695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3779||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3779
71885147|NCT00511355|143290696|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5027||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5027
71885148|NCT00511355|143290697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0041
71885149|NCT00511355|143290698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
71885150|NCT00511355|143290699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0004
71885151|NCT00511355|143290700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0019
71885152|NCT00511355|143290701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9662||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.9662
71885153|NCT00511355|143290702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0187||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0187
71885154|NCT00511355|143290703|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885155|NCT00511355|143290704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6886||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.6886
71885156|NCT00511355|143290705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885157|NCT00511355|143290706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885158|NCT00511355|143290707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0083||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0083
71885159|NCT00511355|143290708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0455||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0455
71885160|NCT00511355|143290709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0063
71885161|NCT00511355|143290710|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885162|NCT00511355|143290711|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885163|NCT00511355|143290712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0078
71885164|NCT00511355|143290713|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0016
71885165|NCT00511355|143290714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0003
71885166|NCT00511355|143290715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0009
71885167|NCT00511355|143290716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.0024
71885168|NCT00511355|143290717|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3653||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.3653
71885169|NCT00511355|143290718|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885170|NCT00511355|143290719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885171|NCT00511355|143290720|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5668||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.5668
71885172|NCT00511355|143290721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||0.1770
71885173|NCT00511355|143290722|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.||||<.0001
71885174|NCT00802685|143290740|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|STANDARD_DEVIATION|8.0||0.858|TWO_SIDED|95.0|4.0|36.0|||Wilcoxon (Mann-Whitney)|||Null hypothesis: Oxygen duration (days) during the first 28 days will be equal between treatment arms.||36|4|0.858
71885175|NCT00802685|143290741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.8|TWO_SIDED|95.0|0.393|2.309|||Cochran-Mantel-Haenszel|||null hypothesis: The proportion of subjects on O2 at 36 wk PMA will be equal between treatment arms.||2.309|0.393|0.8
71885176|NCT03208231|143290747|SUPERIORITY|||||||0.79|||||||Fisher Exact|||||||0.79
71885177|NCT03208231|143290748|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71885178|NCT00644787|143290762|NON_INFERIORITY_OR_EQUIVALENCE|Difference of 7.5 mm in VAS score was selected as the threshold value for clinical non-inferiority of Fentanyl 1-day transdermal patch to Fentanyl 3-day transdermal patch.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.23||||||||6.23|-3.50|
71885179|NCT03048422|143290777|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|2.0|10.7||||||Difference in proportions for intention-to-treat analysis.||10.7|2.0|
71885180|NCT03048422|143290777|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|1.6|10.3||||||Difference in proportions for per-protocol analysis.||10.3|1.6|
71885181|NCT03048422|143290777|SUPERIORITY||Risk Difference (RD)|6.5||||0.005|TWO_SIDED|95.0|2.0|10.7|||Wald test of two proportions|||Difference in proportions for superiority and intention-to-treat analysis.||10.7|2.0|0.005
71885182|NCT03048422|143290778|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
71885183|NCT03048422|143290778|SUPERIORITY||Risk Difference (RD)|0.2||||0.97|TWO_SIDED|95.0|-8.8|9.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||9.1|-8.8|0.97
71885184|NCT03048422|143290778|SUPERIORITY||Risk Difference (RD)|-8.6||||0.047|TWO_SIDED|95.0|-17.1|-0.1|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.1|-17.1|0.047
71885185|NCT03048422|143290779|SUPERIORITY||Risk Difference (RD)|-5.6||||0.098|TWO_SIDED|95.0|-14.2|2.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.9|-14.2|0.098
71885186|NCT03048422|143290779|SUPERIORITY||Risk Difference (RD)|2.6||||0.26|TWO_SIDED|95.0|-5.9|11.7|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF-EFV/FTC/TDF).||11.7|-5.9|0.26
71885187|NCT03048422|143290779|SUPERIORITY||Risk Difference (RD)|-2.8||||0.26|TWO_SIDED|95.0|-11.3|5.8|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF-EFV/FTC/TDF).||5.8|-11.3|0.26
71885188|NCT03048422|143290780|SUPERIORITY||Risk Difference (RD)|-3.2||||0.25|TWO_SIDED|95.0|-12.8|6.3|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.||6.3|-12.8|0.25
71885189|NCT03048422|143290780|SUPERIORITY||Risk Difference (RD)|-2.3||||0.32|TWO_SIDED|95.0|-12.1|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||7.5|-12.1|0.32
71885190|NCT03048422|143290780|SUPERIORITY||Risk Difference (RD)|-5.5||||0.11|TWO_SIDED|95.0|-14.3|3.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||3.2|-14.3|0.11
71885191|NCT03048422|143290781|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.0001|TWO_SIDED|95.0|9.3|22.0|||Wald test of two proportions|||Difference in proportions between arms for intention-to-treat analysis with null hypothesis of no difference (DTG groups - EFV/FTC/TDF).||22.0|9.3|< 0.0001
71885192|NCT03048422|143290782|SUPERIORITY||Risk Difference (RD)|-0.1||||0.97|TWO_SIDED|95.0|-3.3|3.2|||Wald test of two proportions|||Difference in proportions for intention-to-treat analysis with null hypothesis of no difference between arms (DTG arms - EFV/FTC/TDF).||3.2|-3.3|0.97
71885193|NCT03048422|143290783|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.001|TWO_SIDED|95.0|1.9|3.1|||Kaplan-Meier|||||3.1|1.9|< 0.001
71885194|NCT03048422|143290784|SUPERIORITY||Risk Difference (RD)|3.6||||0.19|TWO_SIDED|95.0|-1.8|9.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||9.1|-1.8|0.19
71885195|NCT03048422|143290784|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-17.9|-5.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||-5.2|-17.9|< 0.001
71885196|NCT03048422|143290784|SUPERIORITY||Risk Difference (RD)|-7.9||||0.022|TWO_SIDED|95.0|-14.6|-1.2|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||-1.2|-14.6|0.022
71885197|NCT03048422|143290785|SUPERIORITY||Risk Difference (RD)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.1|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - DTG+FTC/TDF).||10.1|-5.9|0.61
71885198|NCT03048422|143290785|SUPERIORITY||Risk Difference (RD)|-1.4||||0.74|TWO_SIDED|95.0|-9.4|6.6|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TDF - EFV/FTC/TDF).||6.6|-9.4|0.74
71885199|NCT03048422|143290785|SUPERIORITY||Risk Difference (RD)|0.7||||0.86|TWO_SIDED|95.0|-7.4|8.8|||Wald test of two proportions|||Difference between arms with null hypothesis of no difference (DTG+FTC/TAF - EFV/FTC/TDF).||8.8|-7.4|0.86
71885200|NCT03048422|143290786|SUPERIORITY||Risk Difference (RD)|4.3||||0.27|TWO_SIDED|95.0|-3.4|11.9|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG groups - EFV/FTC/TDF).||11.9|-3.4|0.27
71885201|NCT03048422|143290787|SUPERIORITY||Risk Difference (RD)|-0.1||||0.49|TWO_SIDED|95.0|-7.6|7.5|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference combined DTG arms-EFV/FTC/TDF.||7.5|-7.6|0.49
71885202|NCT03048422|143290788|SUPERIORITY||Risk Difference (RD)|4.1||||0.15|TWO_SIDED|95.0|-3.8|12.0|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of combined DTG arms - EFV/FTC/TDF.||12.0|-3.8|0.15
71885203|NCT03048422|143290789|SUPERIORITY||Risk Difference (RD)|-8.8||||0.043|TWO_SIDED|95.0|-17.3|-0.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||-0.3|-17.3|0.043
71885204|NCT03048422|143290789|SUPERIORITY||Risk Difference (RD)|-0.3||||0.95|TWO_SIDED|95.0|-9.3|8.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||8.6|-9.3|0.95
71885205|NCT03048422|143290789|SUPERIORITY||Risk Difference (RD)|-9.1||||0.037|TWO_SIDED|95.0|-17.6|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-0.6|-17.6|0.037
71885206|NCT03048422|143290790|SUPERIORITY||Odds Ratio (OR)|0.73||||0.095|TWO_SIDED|95.0|0.5|1.06|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.06|0.50|0.095
71885207|NCT03048422|143290790|SUPERIORITY||Odds Ratio (OR)|0.83||||0.3|TWO_SIDED|95.0|0.58|1.19|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TDF - EFV/FTC/TDF).||1.19|0.58|0.30
71885208|NCT03048422|143290790|SUPERIORITY||Odds Ratio (OR)|0.6||||0.008|TWO_SIDED|95.0|0.42|0.88|||Regression, Ordinal|||Null hypothesis of odds ratio equal to 1, with odds of experiencing a worse outcome equal between groups (DTG+FTC/TAF - EFV/FTC/TDF).||0.88|0.42|0.008
71885209|NCT03048422|143290791|SUPERIORITY||Risk Difference (RD)|0.5||||0.28|TWO_SIDED|95.0|-1.2|2.1|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||2.1|-1.2|0.28
71885210|NCT03048422|143290791|SUPERIORITY||Risk Difference (RD)|-0.1||||0.47|TWO_SIDED|95.0|-1.5|1.4|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||1.4|-1.5|0.47
71885211|NCT03048422|143290791|SUPERIORITY||Risk Difference (RD)|0.4||||0.31|TWO_SIDED|95.0|-1.3|2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Survival probabilities were compared based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||2.2|-1.3|0.31
71885212|NCT03048422|143290792|SUPERIORITY|The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimated difference of DTG+FTC/TAF - DTG+FTC/TDF.|Risk Difference (RD)|-1.0||||0.2|TWO_SIDED|95.0|-3.4|1.3|||Z-test|||||1.3|-3.4|0.20
71885213|NCT03048422|143290792|SUPERIORITY||Risk Difference (RD)|-4.9||||0.008|TWO_SIDED|95.0|-8.9|-0.9|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TDF-EFV/FTC/TDF.||-0.9|-8.9|0.008
71885214|NCT03048422|143290792|SUPERIORITY||Risk Difference (RD)|-5.9|||<|0.001|TWO_SIDED|95.0|-9.7|-2.2|||Z-test|||The Kaplan-Meier method was used to estimate survival probabilities. Comparisons of survival probabilities was based on a Z-test using Greenwoods estimate of the standard error. The null hypothesis was no difference between arms, with estimate of risk difference DTG+FTC/TAF-EFV/FTC/TDF.||-2.2|-9.7|<0.001
71885215|NCT03048422|143290793|SUPERIORITY||Mean Difference (Final Values)|-0.093||||0.12|TWO_SIDED|95.0|-0.208|0.023|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - DTG+FTC/TDF).||0.023|-0.208|0.12
71885216|NCT03048422|143290793|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.39|TWO_SIDED|95.0|-0.061|0.158|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TDF - EFV/FTC/TDF).||0.158|-0.061|0.39
71885217|NCT03048422|143290793|SUPERIORITY||Mean Difference (Final Values)|-0.045||||0.45|TWO_SIDED|95.0|-0.161|0.072|||Generalized Estimating Equation|||Null hypothesis of no difference in weekly change in creatinine clearance from baseline (DTG+FTC/TAF - EFV/FTC/TDF).||0.072|-0.161|0.45
71885218|NCT03048422|143290794|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.94|TWO_SIDED|95.0|-11.3|10.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - DTG+FTC/TDF).||10.5|-11.3|0.94
71885219|NCT03048422|143290794|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.44|TWO_SIDED|95.0|-6.5|14.9|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TDF - EFV/FTC/TDF).||14.9|-6.5|0.44
71885220|NCT03048422|143290794|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.18|TWO_SIDED|95.0|-1.8|9.3|||t-test, 2 sided|||Null hypothesis of no difference between arms at delivery (DTG+FTC/TAF - EFV/FTC/TDF).||9.3|-1.8|0.18
71885221|NCT03048422|143290794|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.27|TWO_SIDED|95.0|-8.9|31.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - DTG+FTC/TDF).||31.1|-8.9|0.27
71885222|NCT03048422|143290794|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.048|TWO_SIDED|95.0|-22.6|-0.1|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TDF - EFV/FTC/TDF).||-0.1|-22.6|0.048
71885223|NCT03048422|143290794|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|95.0|-21.0|20.5|||t-test, 2 sided|||Null hypothesis of no difference between arms at week 26 (DTG+FTC/TAF - EFV/FTC/TDF).||20.5|-21.0|0.98
71885224|NCT03048422|143290795|SUPERIORITY||Risk Difference (RD)|-0.9||||0.4|TWO_SIDED|95.0|-3.1|1.3|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - DTG+FTC/TDF).||1.3|-3.1|0.40
71885225|NCT03048422|143290795|SUPERIORITY||Risk Difference (RD)|-4.3||||0.023|TWO_SIDED|95.0|-8.0|-0.6|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TDF - EFV/FTC/TDF).||-0.6|-8.0|0.023
71885226|NCT03048422|143290795|SUPERIORITY||Risk Difference (RD)|-5.2||||0.003|TWO_SIDED|95.0|-8.7|-1.8|||Wald test of two proportions|||Null hypothesis of no difference between groups (DTG+FTC/TAF - EFV/FTC/TDF).||-1.8|-8.7|0.003
71885227|NCT03048422|143290797|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-3.6||||0.16|TWO_SIDED|95.0|-8.8|1.5|||Wald test of two proportions|||||1.5|-8.8|0.16
71885228|NCT03048422|143290797|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-2.7||||0.38|TWO_SIDED|95.0|-8.7|3.3|||Wald test of two proportions|||||3.3|-8.7|0.38
71885229|NCT03048422|143290797|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.3||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||Wald test of two proportions|||||-0.9|-11.8|0.023
71945336|NCT00272779|143413787|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL\_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL\_1842 reported in Outcome Measure 16.||||0.1335
71885230|NCT03048422|143290798|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-13.9|1.5|||Wald test of two proportions|||||1.5|-13.9|0.12
71885231|NCT03048422|143290798|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|2.0||||0.63|TWO_SIDED|95.0|-6.0|10.0|||Wald test of two proportions|||||10.0|-6.0|0.63
71885232|NCT03048422|143290798|NON_INFERIORITY|Equivalence margin was a 10% difference between groups.|Risk Difference (RD)|-4.2||||0.28|TWO_SIDED|95.0|-11.7|3.4|||Wald test of two proportions|||||3.4|-11.7|0.28
71885233|NCT03048422|143290799|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.011|TWO_SIDED|95.0|0.013|0.103|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.103|0.013|0.011
71885234|NCT03048422|143290799|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.19|TWO_SIDED|95.0|-0.014|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.070|-0.014|0.19
71885235|NCT03048422|143290799|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.04|0.133|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.133|0.040|< 0.001
71885236|NCT03048422|143290800|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.11|TWO_SIDED|95.0|-0.005|0.048|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.048|-0.005|0.11
71885237|NCT03048422|143290800|SUPERIORITY||Mean Difference (Final Values)|0.024||||0.055|TWO_SIDED|95.0|0.0|0.049|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.049|-0.000|0.055
71885238|NCT03048422|143290800|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.001|TWO_SIDED|95.0|0.022|0.07|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.070|0.022|< 0.001
71885239|NCT03048422|143290801|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.041|TWO_SIDED|95.0|0.001|0.045|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - DTG+FTC/TDF).||0.045|0.001|0.041
71885240|NCT03048422|143290801|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.002|TWO_SIDED|95.0|0.013|0.055|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TDF - EFV/FTC/TDF).||0.055|0.013|0.002
71885241|NCT03048422|143290801|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.036|0.078|||Generalized Estimating Equation|||Null hypothesis of no difference between arms (DTG+FTC/TAF - EFV/FTC/TDF).||0.078|0.036|< 0.001
71885242|NCT01564862|143290812|SUPERIORITY_OR_OTHER||LS mean difference|1.75|STANDARD_ERROR_OF_MEAN|0.744||0.019|TWO_SIDED|95.0|0.28|3.21||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||3.21|0.28|0.019
71885243|NCT01564862|143290812|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.733||0.099|TWO_SIDED|95.0|-0.23|2.65||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||2.65|-0.23|0.099
71885244|NCT01564862|143290812|SUPERIORITY_OR_OTHER||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.725||0.46|TWO_SIDED|95.0|-0.89|1.96||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA|||||1.96|-0.89|0.460
71885245|NCT01564862|143290813|SUPERIORITY_OR_OTHER||LS Mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.1|-1.0||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.0|-4.1|0.001
71885246|NCT01564862|143290813|SUPERIORITY_OR_OTHER||LS mean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.77|<|0.001|TWO_SIDED|95.0|-4.5|-1.5||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-1.5|-4.5|<0.001
71885247|NCT01564862|143290814|SUPERIORITY_OR_OTHER||LS Mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1211||0.017|TWO_SIDED|95.0|-0.528|-0.052||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.052|-0.528|0.017
71885248|NCT01564862|143290814|SUPERIORITY_OR_OTHER||LS mean difference|-0.404|STANDARD_ERROR_OF_MEAN|0.1194|<|0.001|TWO_SIDED|95.0|-0.638|-0.169||P-value was from a MMRM model with baseline\*week, center, week, treatment and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||-0.169|-0.638|<0.001
71885249|NCT01844986|143290827|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
71885250|NCT01844986|143290827|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.23|0.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||0.97|0.23|
71885251|NCT01844986|143290828|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8903|TWO_SIDED|95.0|0.6|1.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||1.53|0.60|0.8903
71885252|NCT01844986|143290828|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.29|2.28||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \< 1 favours olaparib|||2.28|0.29|
71885253|NCT01844986|143290829|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.23|<0.0001
71885254|NCT01844986|143290829|SUPERIORITY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.99||Not applicable due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||0.99|0.23|
71885255|NCT01844986|143290830|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.35|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.35|0.0002
71885256|NCT01844986|143290830|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.23|1.35||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.35|0.23|
71885257|NCT01844986|143290831|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.001|TWO_SIDED|95.0|-4.779|-1.216|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||-1.216|-4.779|0.0010
71885258|NCT01844986|143290832|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
71885259|NCT01844986|143290832|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.29|1.23||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.23|0.29|
71885260|NCT01844986|143290833|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.63|0.32|<0.0001
71885261|NCT01844986|143290833|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.25|1.26||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.26|0.25|
71885262|NCT01844986|143290834|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.51|0.79||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.79|0.51|<0.0001
71885263|NCT01844986|143290834|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.47|1.42||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.|A hazard ratio \<1 favours Olaparib.|||1.42|0.47|
71885264|NCT01844986|143290835|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
71885265|NCT03269344|143290883|SUPERIORITY|||||||0.11|||||||ANOVA|||||||0.11
71885266|NCT03269344|143290884|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71885267|NCT03269344|143290885|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71885268|NCT03269344|143290886|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71885269|NCT03269344|143290887|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71885270|NCT03269344|143290888|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71885271|NCT02597855|143290889|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||The difference of polyp regression rate between two groups were compared.||||<0.05
71885272|NCT02597855|143290890|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney test was used for a comparison of best corrected visual acuity assessed at baseline, 3 months, and 6 months between type1 and type2.||best corrected visual acuity was compared between two groups||||<0.05
71885273|NCT01449708|143290893|SUPERIORITY_OR_OTHER||Relative Risk|1.27||||0.04|TWO_SIDED|95.0|1.01|1.61|||Chi-squared|||||1.61|1.01|0.04
71885274|NCT01449708|143290895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04||||0.009|TWO_SIDED|95.0|1.28|7.29|||Chi-squared|||Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)||7.29|1.28|0.009
71885275|NCT05022641|143290896|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||.6
71885276|NCT05022641|143290897|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||.65
71885277|NCT05022641|143290898|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||.02
71885278|NCT05022641|143290899|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
71885279|NCT05022641|143290901|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||.6
71885280|NCT02889796|143290906|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|20.6|32.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.8|20.6|<0.001
71885281|NCT02889796|143290906|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|13.6|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||26.2|13.6|<0.001
71945337|NCT00272779|143413788|SUPERIORITY_OR_OTHER|||||||0.1335||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN\_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN\_730 reported in Outcome Measure 16.||||0.1335
71701106|NCT02469233|142918222|SUPERIORITY||Time by treatment interaction coeff.|5.68||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.03
71885282|NCT02889796|143290907|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.36|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.36|<0.001
71885283|NCT02889796|143290907|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.24|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.24|<0.001
71885284|NCT02889796|143290908|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|19.6|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||30.0|19.6|<0.001
71885285|NCT02889796|143290908|SUPERIORITY||Difference in Response Rates|14.5|||<|0.001|TWO_SIDED|95.0|9.7|19.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.3|9.7|<0.001
71885286|NCT02889796|143290908|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using non-responder imputation (NRI).|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12.||||<0.001
71885287|NCT02889796|143290908|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 using NRI.||||||0.002||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12.||||0.002
71885288|NCT02889796|143290908|SUPERIORITY||Difference in Response Rates|10.4||||0.001|TWO_SIDED|95.0|3.9|17.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12.||17.0|3.9|0.001
71885289|NCT02889796|143290908|SUPERIORITY||Difference in Response Rates|0.1||||0.99|TWO_SIDED|95.0|-6.2|6.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12.||6.3|-6.2|0.99
71885290|NCT02889796|143290909|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.43|<0.001
71885291|NCT02889796|143290909|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.078||0.001|TWO_SIDED|95.0|-0.4|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.10|-0.40|0.001
71823259|NCT00495469|143149754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.5|||<|0.001|TWO_SIDED|95.0|-53.6|-19.5||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-19.5|-53.6|<0.001
71823260|NCT00495469|143149754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.5||||0.001|TWO_SIDED|95.0|-46.3|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||-12.7|-46.3|0.001
71823261|NCT00495469|143149754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.8||||0.114|TWO_SIDED|95.0|-31.0|3.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||||3.4|-31.0|0.114
71823262|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.757|TWO_SIDED|95.0|0.27|6.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<=6.5%)||6.06|0.27|0.757
71823263|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.58|TWO_SIDED|95.0|0.31|8.01||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<=6.5%)||8.01|0.31|0.580
71823264|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.881|TWO_SIDED|95.0|0.22|5.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<=6.5%)||5.73|0.22|0.881
71823265|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.382|TWO_SIDED|95.0|0.44|8.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<=6.5%)||8.75|0.44|0.382
71823266|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.409|TWO_SIDED|95.0|0.42|8.68||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<=6.5%)||8.68|0.42|0.409
71823267|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.795|TWO_SIDED|95.0|0.24|6.29||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<=6.5%)||6.29|0.24|0.795
71823268|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.765|TWO_SIDED|95.0|0.36|3.95||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7%)||3.95|0.36|0.765
71823269|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.1|TWO_SIDED|95.0|0.82|9.09||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7%)||9.09|0.82|0.100
71823270|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.687|TWO_SIDED|95.0|0.38|4.3||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7%)||4.30|0.38|0.687
71823271|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.409|TWO_SIDED|95.0|0.5|5.52||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7%)||5.52|0.50|0.409
71823272|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81||||0.086|TWO_SIDED|95.0|0.86|9.15||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7%)||9.15|0.86|0.086
71823273|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.369|TWO_SIDED|95.0|0.52|5.88||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7%)||5.88|0.52|0.369
71823274|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.16|TWO_SIDED|95.0|0.74|6.4||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction\>=0.7%)||6.40|0.74|0.160
71823275|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87||||0.014|TWO_SIDED|95.0|1.31|11.42||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||11.42|1.31|0.014
71823276|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.162|TWO_SIDED|95.0|0.73|6.44||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction\>=0.7%)||6.44|0.73|0.162
71823277|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09||||0.011|TWO_SIDED|95.0|1.38|12.17||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction\>=0.7%)||12.17|1.38|0.011
71823278|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.31||||0.003|TWO_SIDED|95.0|1.79|15.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction\>=0.7%)||15.73|1.79|0.003
71823279|NCT00495469|143149755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.264|TWO_SIDED|95.0|0.63|5.49||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction\>=0.7%)||5.49|0.63|0.264
71823280|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.48|TWO_SIDED|95.0|0.46|5.28||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7 mmol/L)||5.28|0.46|0.480
71823281|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.011|TWO_SIDED|95.0|1.44|16.46||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7 mmol/L)||16.46|1.44|0.011
71823282|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.087|TWO_SIDED|95.0|0.85|9.96||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7 mmol/L)||9.96|0.85|0.087
71885292|NCT02889796|143290910|SUPERIORITY||Difference in Response Rates|26.3|||<|0.001|TWO_SIDED|95.0|20.2|32.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||32.4|20.2|<0.001
71885293|NCT02889796|143290910|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||21.4|9.4|<0.001
71885294|NCT02889796|143290910|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 12||||<0.001
71885295|NCT02889796|143290910|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.||||||0.054||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 12||||0.054
71885296|NCT02889796|143290910|SUPERIORITY||Difference in Response Rates|6.3||||0.069|TWO_SIDED|95.0|-1.0|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 12||13.6|-1.0|0.069
71885297|NCT02889796|143290910|SUPERIORITY||Difference in Response Rates|-4.6||||0.18|TWO_SIDED|95.0|-11.8|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 12||2.6|-11.8|0.18
71885298|NCT02889796|143290911|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|2.8|4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.6|2.8|<0.001
71885299|NCT02889796|143290911|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|2.2|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|2.2|<0.001
71885300|NCT02889796|143290912|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.7|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.7|<0.001
71885301|NCT02889796|143290912|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.5|3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.7|1.5|<0.001
71885302|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|8.0|||<|0.001|TWO_SIDED|95.0|5.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||10.9|5.1|<0.001
71885303|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|4.8|||<|0.001|TWO_SIDED|95.0|2.3|7.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.3|2.3|<0.001
71885304|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|16.4|||<|0.001|TWO_SIDED|95.0|11.9|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||20.9|11.9|<0.001
71885305|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|7.0|||<|0.001|TWO_SIDED|95.0|3.1|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||10.9|3.1|<0.001
71885306|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|21.4|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||33.3|21.4|<0.001
71885307|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|16.7|||<|0.001|TWO_SIDED|95.0|10.9|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||22.5|10.9|<0.001
71885308|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|24.6|||<|0.001|TWO_SIDED|95.0|18.3|31.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||31.0|18.3|<0.001
71885309|NCT02889796|143290913|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
71885310|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|2.3||||0.008|TWO_SIDED|95.0|0.5|4.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||4.1|0.5|0.008
71885311|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|0.8||||0.18|TWO_SIDED|95.0|-0.5|2.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||2.2|-0.5|0.18
71885312|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|4.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||10.6|4.6|<0.001
71885313|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|1.9||||0.067|TWO_SIDED|95.0|-0.3|4.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||4.0|-0.3|0.067
71885314|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|14.6|24.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||24.1|14.6|<0.001
71885315|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.5|16.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||16.2|7.5|<0.001
71885316|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|21.3|||<|0.001|TWO_SIDED|95.0|15.7|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||26.9|15.7|<0.001
71885317|NCT02889796|143290915|SUPERIORITY||Difference in Response Rates|14.6|||<|0.001|TWO_SIDED|95.0|9.2|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.0|9.2|<0.001
71885318|NCT02889796|143290917|SUPERIORITY||Difference in Response Rates|22.3|||<|0.001|TWO_SIDED|95.0|16.7|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||27.9|16.7|<0.001
71885319|NCT02889796|143290917|SUPERIORITY||Difference in Response Rates|12.6|||<|0.001|TWO_SIDED|95.0|7.2|17.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||17.9|7.2|<0.001
71885320|NCT02889796|143290917|SUPERIORITY||Difference in Response Rates|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||26.1|13.4|<0.001
71885321|NCT02889796|143290917|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|7.5|20.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||20.2|7.5|<0.001
71885322|NCT02889796|143290917|SUPERIORITY||Difference in Response Rates|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||24.9|13.0|<0.001
71885323|NCT02889796|143290917|SUPERIORITY||Difference in Response Rates|18.6|||<|0.001|TWO_SIDED|95.0|12.6|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||24.5|12.6|<0.001
71885324|NCT02889796|143290919|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.22|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.22|<0.001
71885325|NCT02889796|143290919|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|-0.14|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.14|<0.001
71885326|NCT02889796|143290919|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.24|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.24|<0.001
71885327|NCT02889796|143290919|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.028|<|0.001|TWO_SIDED|95.0|-0.15|-0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.15|<0.001
71885328|NCT02889796|143290919|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.34|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.34|<0.001
71885329|NCT02889796|143290919|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.26|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.26|<0.001
71885330|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
71885331|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.01|TWO_SIDED|95.0|-3.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-3.0|0.010
71885332|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
71885333|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71885334|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
71885335|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71885336|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
71885337|NCT02889796|143290921|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71823283|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.082|TWO_SIDED|95.0|0.87|9.78||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7 mmol/L)||9.78|0.87|0.082
71701107|NCT02469233|142918222|SUPERIORITY||Time by treatment interaction coeff.|5.89||||0.03|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.03
71823284|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.024|TWO_SIDED|95.0|1.2|13.27||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7 mmol/L)||13.27|1.20|0.024
71823285|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.012|TWO_SIDED|95.0|1.41|16.66||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7 mmol/L)||16.66|1.41|0.012
71823286|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.27|TWO_SIDED|95.0|0.62|5.54||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (\<7.8 mmol/L)||5.54|0.62|0.270
71823287|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.18||||0.043|TWO_SIDED|95.0|1.04|9.72||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (\<7.8 mmol/L)||9.72|1.04|0.043
71823288|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.169|TWO_SIDED|95.0|0.72|6.53||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (\<7.8 mmol/L)||6.53|0.72|0.169
71823289|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.042|TWO_SIDED|95.0|1.04|9.36||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (\<7.8 mmol/L)||9.36|1.04|0.042
71823290|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0.02|TWO_SIDED|95.0|1.23|11.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (\<7.8 mmol/L)||11.06|1.23|0.020
71885338|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.002
71885339|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.047|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|0.047
71885340|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71885341|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71885342|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71885343|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
71885344|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71885345|NCT02889796|143290923|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
71885346|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-11.0|<0.001
71885347|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
71738831|NCT03078855|142990513|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.26|TWO_SIDED|95.0|0.83|1.98|||Regression, Cox||The EFS hazard ratio was adjusted for enrolling site, continuous age at randomization, and (via stratification) 3 randomization strata: non-follicular histology, follicular (FL) with low/intermediate FLIPI score and FL with high FLIPI score.|||1.98|0.83|0.26
71885348|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
71945338|NCT00272779|143413789|SUPERIORITY_OR_OTHER|||||||0.1696||95.0||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values \<0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122\_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122\_5980 reported in Outcome Measure 16.||||0.1696
71885349|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
71885350|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
71885351|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
71885352|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
71885353|NCT02889796|143290925|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
71885354|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
71885355|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-8.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-8.0|<0.001
71885356|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
71885357|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-9.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-9.0|<0.001
71885358|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-10.0|<0.001
71885359|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
71885360|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-11.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-11.0|<0.001
71885361|NCT02889796|143290927|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-10.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-10.0|<0.001
71885362|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
71885363|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
71885364|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
71885365|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-9.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-9.0|<0.001
71885366|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
71885367|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-13.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-13.0|<0.001
71885368|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-14.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-14.0|<0.001
71885369|NCT02889796|143290929|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
71885370|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-10.83|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-12.7|-8.96||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.96|-12.70|<0.001
71885371|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|0.947|<|0.001|TWO_SIDED|95.0|-9.58|-5.87||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.87|-9.58|<0.001
71885372|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-9.39|STANDARD_ERROR_OF_MEAN|0.989|<|0.001|TWO_SIDED|95.0|-11.33|-7.45||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.45|-11.33|<0.001
71823291|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.211|TWO_SIDED|95.0|0.67|6.24||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (\<7.8 mmol/L)||6.24|0.67|0.211
71885373|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-9.29|-5.42||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.42|-9.29|<0.001
71885374|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-8.02|STANDARD_ERROR_OF_MEAN|0.961|<|0.001|TWO_SIDED|95.0|-9.9|-6.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.13|-9.90|<0.001
71885375|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-8.35|-4.58||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.58|-8.35|<0.001
71885376|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-7.91|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-9.88|-5.93||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.93|-9.88|<0.001
71885377|NCT02889796|143290931|SUPERIORITY||Least Squares Mean Difference|-6.59|STANDARD_ERROR_OF_MEAN|1.005|<|0.001|TWO_SIDED|95.0|-8.56|-4.62||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.62|-8.56|<0.001
71885378|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|12.3|||<|0.001|TWO_SIDED|95.0|5.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||18.9|5.7|<0.001
71885379|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|6.5||||0.043|TWO_SIDED|95.0|-0.1|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||13.1|-0.1|0.043
71885380|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.8|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||22.8|9.8|<0.001
71885381|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|8.1||||0.011|TWO_SIDED|95.0|1.5|14.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||14.7|1.5|0.011
71885382|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|21.0|||<|0.001|TWO_SIDED|95.0|14.9|27.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||27.0|14.9|<0.001
71885383|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|13.6|||<|0.001|TWO_SIDED|95.0|7.3|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||19.9|7.3|<0.001
71885384|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|10.5|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||22.8|10.5|<0.001
71885385|NCT02889796|143290933|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|7.8|20.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||20.3|7.8|<0.001
71885386|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
71885387|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.5|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.5|<0.001
71885388|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-0.9|<0.001
71823292|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.179|TWO_SIDED|95.0|0.61|13.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction \>=1.7 mmol/L)||13.75|0.61|0.179
71885389|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
71885390|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
71885391|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
71885392|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
71885393|NCT02889796|143290935|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
71885394|NCT02889796|143290937|SUPERIORITY||Difference in Response Rates|9.5|||<|0.001|TWO_SIDED|95.0|5.8|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2||13.1|5.8|<0.001
71885395|NCT02889796|143290937|SUPERIORITY||Difference in Response Rates|4.5||||0.004|TWO_SIDED|95.0|1.4|7.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2||7.7|1.4|0.004
71885396|NCT02889796|143290937|SUPERIORITY||Difference in Response Rates|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||21.1|11.3|<0.001
71885397|NCT02889796|143290937|SUPERIORITY||Difference in Response Rates|11.2|||<|0.001|TWO_SIDED|95.0|6.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||15.8|6.5|<0.001
71885398|NCT02889796|143290937|SUPERIORITY||Difference in Response Rates|26.9|||<|0.001|TWO_SIDED|95.0|20.6|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|20.6|<0.001
71885399|NCT02889796|143290937|SUPERIORITY||Difference in Response Rates|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||25.8|13.1|<0.001
71885400|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|4.4|||<|0.001|TWO_SIDED|95.0|2.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 2.||6.7|2.1|<0.001
71885401|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|1.0||||0.17|TWO_SIDED|95.0|-0.5|2.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 2.||2.6|-0.5|0.17
71885402|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||14.4|7.1|<0.001
71885403|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|5.8|||<|0.001|TWO_SIDED|95.0|2.6|9.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||9.0|2.6|<0.001
71885404|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|32.2|||<|0.001|TWO_SIDED|95.0|26.4|38.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.0|26.4|<0.001
71945339|NCT02440711|143413803|SUPERIORITY|||||||0.18||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at slow walking speed||||.18
71885405|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|13.4|24.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||24.6|13.4|<0.001
71885406|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|12.7|||<|0.001|TWO_SIDED|95.0|5.6|19.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Adalimumab at Week 24.||19.9|5.6|<0.001
71885407|NCT02889796|143290939|SUPERIORITY||Difference in Response Rates|-0.5||||0.88|TWO_SIDED|95.0|-7.5|6.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Adalimumab at Week 24.||6.5|-7.5|0.88
71885408|NCT02889796|143290939|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 200 mg vs Adalimumab at Week 24.||||<0.001
71885409|NCT02889796|143290939|NON_INFERIORITY|For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) \< 2.6 at using NRI.|||||<|0.001||||||P-value of non-inferiority test was calculated from approach proposed by \[Liu 2014\].|Method proposed by [Liu 2014]|||Filgotinib 100 mg vs Adalimumab at Week 24.||||<0.001
71885410|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-5.9|-3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.2|-5.9|<0.001
71885411|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-4.3|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.3|<0.001
71885412|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-6.6|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-6.6|<0.001
71885413|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-5.3|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-5.3|<0.001
71885414|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-7.3|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.3|<0.001
71885415|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0|-5.8|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-5.8|<0.001
71885416|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-6.9|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-6.9|<0.001
71885417|NCT02889796|143290945|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
71885418|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.1|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.1|<0.001
71885419|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-5.0|<0.001
71945340|NCT02440711|143413803|SUPERIORITY|||||||0.21||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at comfortable walking speed||||.21
71945341|NCT02440711|143413803|SUPERIORITY|||||||0.16||||||A significance threshold for all analyses was set at α=0.05. Bonferroni corrections for multiple comparisons were applied.|Multivariate regression|The multivariate regression included participants' biological masses and walking speeds as covariates.||Analysis of VO2 at fast walking speed||||.16
71885420|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-7.6|-4.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.6|-7.6|<0.001
71885421|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-6.0|-3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.1|-6.0|<0.001
71885422|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-8.2|-5.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.4|-8.2|<0.001
71885423|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|-6.5|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-6.5|<0.001
71885424|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-7.8|-5.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.3|-7.8|<0.001
71885425|NCT02889796|143290947|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-6.1|-3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.5|-6.1|<0.001
71885426|NCT02889796|143290949|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.042|TWO_SIDED|95.0|-0.77|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.77|0.042
71885427|NCT02889796|143290949|SUPERIORITY||Least Squares Mean Difference|-0.39||||0.039|TWO_SIDED|95.0|-0.77|-0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.02|-0.77|0.039
71885428|NCT02889796|143290950|SUPERIORITY||Difference in non-progression rate|6.6||||0.002|TWO_SIDED|95.0|2.2|11.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||11.1|2.2|0.002
71885429|NCT02889796|143290950|SUPERIORITY||Difference in non-progression rate|3.9||||0.073|TWO_SIDED|95.0|-0.8|8.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.5.||8.6|-0.8|0.073
71885430|NCT02889796|143290950|SUPERIORITY||Difference in non-progression rate|7.0||||0.009|TWO_SIDED|95.0|1.5|12.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||12.5|1.5|0.009
71885431|NCT02889796|143290950|SUPERIORITY||Difference in non-progression rate|5.0||||0.061|TWO_SIDED|95.0|-0.6|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ 0.||10.6|-0.6|0.061
71885432|NCT02889796|143290950|SUPERIORITY||Difference in non-progression rate|5.5||||0.004|TWO_SIDED|95.0|1.6|9.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||9.4|1.6|0.004
71885433|NCT02889796|143290950|SUPERIORITY||Difference in non-progression rate|4.7||||0.012|TWO_SIDED|95.0|0.7|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24 for change in mTSS ≤ SDC (1.36).||8.8|0.7|0.012
71885434|NCT02889796|143290954|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.9|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.9|<0.001
71945342|NCT02440711|143413805|SUPERIORITY|||||||0.29||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.29
71945343|NCT02440711|143413807|SUPERIORITY|||||||0.05||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.05
71885435|NCT02889796|143290954|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.0|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|1.0|<0.001
71885436|NCT02889796|143290954|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.1|<0.001
71885437|NCT02889796|143290954|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.0|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.0|<0.001
71885438|NCT02889796|143290958|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|0.9|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.9|<0.001
71885439|NCT02889796|143290958|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.48||0.002|TWO_SIDED|95.0|0.6|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.6|0.002
71885440|NCT02889796|143290958|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.52||0.006|TWO_SIDED|95.0|0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|0.4|0.006
71885441|NCT02889796|143290958|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.52||0.001|TWO_SIDED|95.0|0.7|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|0.7|0.001
71885442|NCT02889796|143290958|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.086|TWO_SIDED|95.0|-0.1|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.1|0.086
71885443|NCT02889796|143290958|SUPERIORITY||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.55||0.12|TWO_SIDED|95.0|-0.2|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-0.2|0.12
71885444|NCT02889796|143290962|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.8|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.8|<0.001
71885445|NCT02889796|143290962|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.2|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|1.2|<0.001
71885446|NCT02889796|143290962|SUPERIORITY||Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.5|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.5|<0.001
71945344|NCT02440711|143413809|SUPERIORITY|||||||0.25||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.25
71945345|NCT02440711|143413811|SUPERIORITY|||||||0.86||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.86
71945346|NCT02440711|143413813|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step length results||||.14
71885447|NCT02889796|143290962|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.6|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.6|<0.001
71885448|NCT02889796|143290968|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.049|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|0.0|0.049
71885449|NCT02889796|143290968|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.069|TWO_SIDED|95.0|0.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-0.0|0.069
71885450|NCT02889796|143290968|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
71885451|NCT02889796|143290968|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|4.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|4.0|<0.001
71885452|NCT02889796|143290968|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.5||0.06|TWO_SIDED|95.0|0.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-0.0|0.060
71885453|NCT02889796|143290968|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.003
71885454|NCT01394081|143290991|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<.0001
71885455|NCT01394081|143290992|SUPERIORITY||||||<|0.0001|||||||Log Rank|log rank Mantel Cox χ2 = 25.4||||||<.0001
71885456|NCT02814565|143291005|SUPERIORITY|||||||0.6179|TWO_SIDED|95.0|||||Wilcoxon Rank Sum test|||The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6179
71885457|NCT02814565|143291006|SUPERIORITY|||||||0.4338|||||||Wilcoxon Rank Sum Test|||Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4338
71885458|NCT02814565|143291006|SUPERIORITY|||||||0.1657|||||||Wilcoxon Rank Sum Test|||Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1657
71885459|NCT02814565|143291007|SUPERIORITY|||||||0.0393|||||||Wilcoxon Sum Rank Test|||The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0393
71945347|NCT02440711|143413813|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step length results||||<0.001
71945348|NCT02440711|143413815|SUPERIORITY|||||||0.61||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Prosthetic side step time results||||.61
71945349|NCT02440711|143413815|SUPERIORITY|||||||0.4||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||Sound side step time results||||.40
71945350|NCT02440711|143413817|SUPERIORITY|||||||0.14||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||.14
71945351|NCT02440711|143413819|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
71945352|NCT02440711|143413821|SUPERIORITY|||||||0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.001
71885460|NCT02814565|143291008|SUPERIORITY|||||||0.033|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0330
71885461|NCT02814565|143291008|SUPERIORITY|||||||0.0262|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0262
71885462|NCT02814565|143291009|SUPERIORITY|||||||0.5756|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5756
71885463|NCT02814565|143291009|SUPERIORITY|||||||0.4395|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4395
71885464|NCT02814565|143291009|SUPERIORITY|||||||0.0905|||||||Wilcoxon Sum Rank Test|||Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0905
71885465|NCT02814565|143291010|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 3. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
71885466|NCT02814565|143291010|SUPERIORITY|||||||1|||||||Fisher Exact|||"Day 7. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||1.0000
71885467|NCT02814565|143291010|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||"Day 14. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."||||0.2757
71885468|NCT02814565|143291011|SUPERIORITY|||||||0.302|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.3020
71885469|NCT02814565|143291011|SUPERIORITY|||||||0.2367|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2367
71885470|NCT02814565|143291011|SUPERIORITY|||||||0.025|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0250
71885471|NCT02814565|143291012|SUPERIORITY|||||||0.4428|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.4428
71885472|NCT02814565|143291012|SUPERIORITY|||||||0.1163|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.1163
71885473|NCT02814565|143291012|SUPERIORITY|||||||0.0489|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0489
71945353|NCT02440711|143413823|SUPERIORITY|||||||0.005||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||||||0.005
71885474|NCT02814565|143291013|SUPERIORITY|||||||0.5275|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.5275
71885475|NCT02814565|143291013|SUPERIORITY|||||||0.088|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0880
71885476|NCT02814565|143291013|SUPERIORITY|||||||0.2542|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2542
71885477|NCT02814565|143291014|SUPERIORITY|||||||0.692|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.6920
71885478|NCT02814565|143291014|SUPERIORITY|||||||0.0749|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.0749
71885479|NCT02814565|143291014|SUPERIORITY|||||||0.2371|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.||||0.2371
71885480|NCT02653768|143291041|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|95.0|-8.2|-2.0||||||This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||-2.0|-8.2|
71945354|NCT02440711|143413825|SUPERIORITY|||||||0.002||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AR results||||0.002
71945355|NCT02440711|143413825|SUPERIORITY||||||<|0.001||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-FUN results||||<0.001
71885481|NCT02653768|143291041|OTHER|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.2|2.3||||||This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.||2.3|-5.2|
71885482|NCT02653768|143291041|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0003|TWO_SIDED|95.0|-10.5|-3.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.||-3.2|-10.5|0.0003
71885483|NCT02653768|143291042|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.43|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.||1.3|-0.6|0.43
71885484|NCT02653768|143291043|OTHER||Mean Difference (Final Values)|-2.3||||0.23|TWO_SIDED|95.0|-6.1|1.5|||Mixed Models Analysis|||||1.5|-6.1|0.23
71885485|NCT01784965|143291044|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71885486|NCT05215600|143291048|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
71885487|NCT05215600|143291049|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.001|||||||t-test, 2 sided|T-Test (Pooled)||||||<0.001
71885488|NCT04175626|143291051|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint was evaluated by performing an exact, binomial test comparing the rate of TLF for the Orsiro stent at 1 year to a performance goal of 6.9%, with Type I error (alpha) of 0.025 and power of 80%. The null hypothesis (Ho) was stated as: The TLF rate of the Orsiro stent at 1 year is greater than or equal to 6.9%. The alternative hypothesis (Ha) was stated as: The TLF rate of the Orsiro stent at 1 year is less than 6.9%.||||<0.0001
71885489|NCT03178487|143291064|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Response Rate Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for stratification factor of Screening hsCRP level.|Response Rate Difference = Upadacitinib - Placebo|||39.5|12.6|<0.001
71885490|NCT03178487|143291065|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|Least Squares (LS) Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.14|-0.68|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.14|<0.001
71885491|NCT03178487|143291066|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.|LS Mean Difference|-6.71|||<|0.001|TWO_SIDED|95.0|-9.01|-4.41|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.41|-9.01|<0.001
71885492|NCT03178487|143291067|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASDAI 50; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|21.8||||0.002|TWO_SIDED|95.0|8.5|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||35.0|8.5|0.002
71885493|NCT03178487|143291068|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASQoL; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.54||||0.016|TWO_SIDED|95.0|-2.78|-0.3|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.30|-2.78|0.016
71885494|NCT03178487|143291069|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including ASAS PR; within the group, the allocated α was adjusted based on the magnitude of p values.|Response Rate Difference|18.3|||<|0.001|TWO_SIDED|95.0|10.0|26.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|Response rate difference = Upadacitinib - Placebo|||26.6|10.0|<0.001
71885495|NCT03178487|143291070|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASFI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-1.0||||0.001|TWO_SIDED|95.0|-1.6|-0.39|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.39|-1.60|0.001
71945356|NCT02440711|143413825|SUPERIORITY|||||||0.85||||||Holm-Bonferroni adjustments for multiple comparisons were applied to yield an experiment-wise alpha level of .05.|t-test, 2 sided|||TAPES-AES results||||0.85
71885496|NCT03178487|143291071|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including BASMI(lin); within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.22||||0.03|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.02|-0.43|0.030
71885497|NCT03178487|143291072|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including MASES; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-0.84||||0.049|TWO_SIDED|95.0|-1.68|0.0|||Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.00|-1.68|0.049
71885498|NCT03178487|143291073|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint. The testing sequence included a group of endpoints tested by the Hochberg procedure, including WPAI; within the group, the allocated α was adjusted based on the magnitude of p values.|LS Mean Difference|-5.52||||0.19|TWO_SIDED|95.0|-13.82|2.78|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||2.78|-13.82|0.190
71885499|NCT03178487|143291074|OTHER|"To preserve the overall type I error rate at α=0.05 level, a step-down approach was used to test the primary and multiplicity-controlled key secondary endpoints. The testing began with the primary endpoint at α=0.05 and continued conditional on significance of higher-ranked endpoint.~ASAS HI was to be evaluated only if the group of endpoints tested by Hochberg procedure were all significant."|LS Mean Difference|-1.37||||0.007|TWO_SIDED|95.0|-2.37|-0.37||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped during the Hochberg procedure.|Mixed Effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction as fixed effects and Screening hsCRP level and Baseline value as covariates.|Treatment difference = Upadacitinib - Placebo|||-0.37|-2.37|0.007
71885500|NCT03178487|143291075|OTHER||Response Rate Difference|24.1||||0.001|TWO_SIDED|95.0|10.2|38.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factor of Screening hsCRP level.|||Response Rate Difference = Upadacitinib - Placebo|38.0|10.2|0.001
71885501|NCT03178487|143291076|OTHER||LS Mean Difference|-3.69|||<|0.001|TWO_SIDED|95.0|-5.31|-2.08||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.08|-5.31|<0.001
71885502|NCT03178487|143291077|OTHER||LS Mean Difference|-6.21|||<|0.001|TWO_SIDED|95.0|-8.27|-4.14|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-4.14|-8.27|<0.001
71885503|NCT03178487|143291078|OTHER||LS Mean Difference|-2.55|||<|0.001|TWO_SIDED|95.0|-4.01|-1.08|||ANCOVA|ANCOVA model including treatment and Screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.08|-4.01|<0.001
71885504|NCT01562548|143291081|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.21||||0.68|TWO_SIDED|95.0|-1.23|0.8||P-value was associated with t-test for difference of LS means|t-test, 2 sided|The model included factors for treatment (as a fixed effect) and site (as a random effect).|Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||0.80|-1.23|0.68
71885505|NCT01562548|143291081|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.35||||0.52|TWO_SIDED|95.0|-0.72|1.42||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.42|-0.72|0.52
71945357|NCT01980771|143413827|SUPERIORITY||Odds Ratio (OR)|1.58||||0.04|TWO_SIDED|95.0|1.03|2.43|||Mixed Models Analysis|||||2.43|1.03|0.04
71823293|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.93||||0.03|TWO_SIDED|95.0|1.17|20.87||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction \>=1.7 mmol/L)||20.87|1.17|0.030
71945358|NCT00984022|143413867|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Fisher Exact|||The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.||||.0003
71945359|NCT00984022|143413868|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Main effect for type of dressing.|ANOVA|||Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.||||.043
71945360|NCT00984022|143413869|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.||||.847
71885506|NCT01562548|143291081|SUPERIORITY_OR_OTHER||Least Squares Means Difference|0.24||||0.58|TWO_SIDED|95.0|-0.64|1.13||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.||1.13|-0.64|0.58
71885507|NCT00493038|143291092|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|2.1||||||95.0|-1.9|6.2|||||Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.2|-1.9|
71885508|NCT00493038|143291093|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|-0.5||||||95.0|-7.9|6.8||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.8|-7.9|
71885509|NCT00493038|143291094|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population."|Mean Difference (Final Values)|1.7||||||95.0|-3.8|7.1||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.1|-3.8|
71885510|NCT00119158|143291119|NON_INFERIORITY_OR_EQUIVALENCE|modified EASI (eczema area severity index) was considered equivalent if p value was greater than \>0.05|||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71885511|NCT04311086|143291159|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
71885512|NCT04311086|143291160|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
71885513|NCT04311086|143291161|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment||||>0.05
71885514|NCT04311086|143291162|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
71885515|NCT04311086|143291166|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||<0.05
71885516|NCT04311086|143291167|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||<|0.05|||||||ANCOVA|||||||<0.05
71885517|NCT04311086|143291168|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
71885518|NCT04311086|143291169|OTHER|A propensity score will be estimated for each patient from a multivariable logistic regression model, which is the probability that the patient is in DYSTAL cohort. In this model, the DYSTAL cohort (binary variable) is the outcome variable, and the following covariates will be considered as independent variables for propensity score analysis model: baseline Office and 24-hour ABPM (continuous) SBP and DBP, age (continuous), gender (dichotomous), BMI (continuous), diabetes (dichotomous).|||||>|0.05|||||||ANCOVA|||Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.||||>0.05
71885519|NCT01175902|143291170|NON_INFERIORITY_OR_EQUIVALENCE|"To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.~In this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP."|Mean Difference (Final Values)|0.9||||0.05|TWO_SIDED|||||Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|t-test, 2 sided|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.||||0.05
71885520|NCT03728309|143291176|SUPERIORITY||Percentage Difference|53.5|||<|0.001|TWO_SIDED|95.0|43.5|63.5||The p-value and 95% CI are computed by pooling 30 imputed data sets using SAS PROC MIANALYZE with normal approximation.|SAS PROC MIANALYZE|||||63.5|43.5|<0.001
71885521|NCT03728309|143291178|SUPERIORITY||Mean Difference (Final Values)|28.0|STANDARD_ERROR_OF_MEAN|3.83|<|0.001|TWO_SIDED|95.0|21.0|36.0|||2-sample, t-test|||||36.0|21.0|<0.001
71885522|NCT03728309|143291179|SUPERIORITY||Percentage Difference|52.9|||<|0.001|TWO_SIDED|95.0|40.1|65.7|||Fisher's Exact Test||Comparison of treatment group versus control group at Month 1, responder rate difference, 95% CI for risk difference and p-value was estimated based on Fisher's exact test using mITT population with baseline AFLS score of 2 or 3 on both cheeks.|||65.7|40.1|<0.001
71885523|NCT01703858|143291219|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.68|STANDARD_DEVIATION|10.0||0|TWO_SIDED|90.0|92.501|105.272|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.272|92.501|0.0000
71885524|NCT01703858|143291219|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.16|STANDARD_DEVIATION|18.3||0.9644|TWO_SIDED|90.0|62.331|78.962|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||78.962|62.331|0.9644
71885525|NCT01703858|143291219|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.36|STANDARD_DEVIATION|18.8||0.2835|TWO_SIDED|90.0|73.648|94.346|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.346|73.648|0.2835
71885526|NCT01703858|143291219|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.18|STANDARD_DEVIATION|16.7||0.1599|TWO_SIDED|90.0|104.923|130.867|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.867|104.923|0.1599
71885527|NCT01703858|143291219|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.4|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.072|107.719|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.719|88.072|0.0020
71885528|NCT01703858|143291220|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|89.26|STANDARD_DEVIATION|25.3||0.1261|TWO_SIDED|90.0|75.893|104.973|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||104.973|75.893|0.1261
71885529|NCT01703858|143291220|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|54.57|STANDARD_DEVIATION|47.4||0.9808|TWO_SIDED|90.0|40.711|73.157|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||73.157|40.711|0.9808
71885530|NCT01703858|143291220|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|94.88|STANDARD_DEVIATION|43.2||0.1449|TWO_SIDED|90.0|72.175|124.731|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||124.731|72.175|0.1449
71885531|NCT01703858|143291220|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|169.46|STANDARD_DEVIATION|49.7||0.9463|TWO_SIDED|90.0|124.093|231.419|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||231.419|124.093|0.9463
71885532|NCT01703858|143291220|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|81.06|STANDARD_DEVIATION|33.3||0.4564|TWO_SIDED|90.0|65.811|99.848|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||99.848|65.811|0.4564
71885533|NCT01703858|143291221|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.66|STANDARD_DEVIATION|9.9||0|TWO_SIDED|90.0|92.5|105.225|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution||105.225|92.500|0.0000
71885534|NCT01703858|143291221|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.24|STANDARD_DEVIATION|18.3||0.9635|TWO_SIDED|90.0|62.43|79.038|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect||79.038|62.430|0.9635
71945361|NCT00573443|143413871|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5312|||<|0.0001|TWO_SIDED|95.0|0.4939|0.5714|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-30/placebo = 1.||0.5714|0.4939|<0.0001
71945362|NCT00573443|143413871|SUPERIORITY_OR_OTHER||Ratio of episode-rate reduction ratios|0.5103|||<|0.0001|TWO_SIDED|95.0|0.4755|0.5477|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-20/placebo = 1.||0.5477|0.4755|<0.0001
71945363|NCT00905606|143413878|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|93.91||||||90.0|85.42|103.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.25|85.42|
71885535|NCT01703858|143291221|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.46|STANDARD_DEVIATION|18.7||0.2771|TWO_SIDED|90.0|73.774|94.412|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect||94.412|73.774|0.2771
71885536|NCT01703858|143291221|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.16|STANDARD_DEVIATION|16.6||0.1584|TWO_SIDED|90.0|104.958|130.787|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect||130.787|104.958|0.1584
71885537|NCT01703858|143291221|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.41|STANDARD_DEVIATION|15.8||0.002|TWO_SIDED|90.0|88.066|107.741|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect||107.741|88.066|0.0020
71885538|NCT00993031|143291237|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.76|TWO_SIDED|95.0|0.26|2.67|||Chi-squared|||||2.67|.26|.76
71885539|NCT00993031|143291238|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.76|TWO_SIDED|95.0|0.29|2.46|||Chi-squared|||||2.46|.29|.76
71885540|NCT00993031|143291239|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.45|TWO_SIDED|95.0|0.36|1.59|||Chi-squared|||||1.59|.36|.45
71885541|NCT00993031|143291241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.66|||Chi-squared|||||1.66|.89|.21
71885542|NCT00993031|143291242|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.06|TWO_SIDED|95.0|0.98|1.83|||Chi-squared|||||1.83|.98|.06
71885543|NCT01097304|143291308|OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
71885544|NCT01097304|143291309|OTHER||||||<|0.0001|||||||signed rank test|||||||<0.0001
71885545|NCT01097304|143291310|OTHER||||||<|0.01|||||||signed rank test|||||||<0.01
71885546|NCT01097304|143291311|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
71885547|NCT02573155|143291326|SUPERIORITY_OR_OTHER||Least Square Mean|0.111|STANDARD_ERROR_OF_MEAN|0.0265|<|0.0001|TWO_SIDED|95.0|0.0585|0.163|||ANCOVA|||||0.163|0.0585|<0.0001
71885548|NCT02573155|143291326|SUPERIORITY_OR_OTHER||Least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.0272|<|0.0001||95.0|0.156|0.264|||ANCOVA|||||0.264|0.156|<0.0001
71885549|NCT02301403|143291340|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.69|5.14|||Regression, Logistic|||||5.14|1.69|<.001
71885550|NCT02321436|143291364|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified log rank test.||||||0.0176||||||Significance level (α) = 5%|Log Rank|||||||0.0176
71885551|NCT02321436|143291364|OTHER|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified Wilcoxon test.||||||0.048||||||Significance level (α) = 5%|Wilcoxon (Mann-Whitney)|||||||0.0480
71885552|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.0||||0.0005|TWO_SIDED|95.0|-1.54|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||-0.47|-1.54|0.0005
71885553|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0007|TWO_SIDED|95.0|-1.63|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||-0.47|-1.63|0.0007
71885554|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0006|TWO_SIDED|95.0|-1.62|-0.48||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||-0.48|-1.62|0.0006
71885555|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.84||||0.0027|TWO_SIDED|95.0|-1.36|-0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||-0.31|-1.36|0.0027
71885556|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.83||||0.0052|TWO_SIDED|95.0|-1.39|-0.26||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||-0.26|-1.39|0.0052
71885557|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.52||||0.2037|TWO_SIDED|95.0|-1.35|0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||0.31|-1.35|0.2037
71885558|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.15||||0.7656|TWO_SIDED|95.0|-1.25|0.94||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||0.94|-1.25|0.7656
71885559|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.12||||0.8521|TWO_SIDED|95.0|-1.46|1.23||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||1.23|-1.46|0.8521
71885560|NCT02321436|143291365|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.21||||0.6582|TWO_SIDED|95.0|-1.24|0.81||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||0.81|-1.24|0.6582
71885561|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|0.8||||0.8754|TWO_SIDED|95.0|-9.5|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).||11.1|-9.5|0.8754
71885562|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.9||||0.8805|TWO_SIDED|95.0|-12.8|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).||11.1|-12.8|0.8805
71885563|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-2.2||||0.6992|TWO_SIDED|95.0|-14.0|9.6||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).||9.6|-14.0|0.6992
71885564|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.1||||0.9882|TWO_SIDED|95.0|-13.0|12.8||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).||12.8|-13.0|0.9882
71885565|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|4.6||||0.5646|TWO_SIDED|95.0|-11.9|21.2||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).||21.2|-11.9|0.5646
71885566|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-12.5||||0.2325|TWO_SIDED|95.0|-34.0|9.0||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).||9.0|-34.0|0.2325
71885567|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-14.1||||0.2441|TWO_SIDED|95.0|-39.4|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).||11.1|-39.4|0.2441
71885568|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-9.0||||0.4311|TWO_SIDED|95.0|-33.7|15.7||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).||15.7|-33.7|0.4311
71885569|NCT02321436|143291366|OTHER|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-4.5||||0.731|TWO_SIDED|95.0|-33.3|24.3||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).||24.3|-33.3|0.7310
71823294|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99||||0.142|TWO_SIDED|95.0|0.69|12.86||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (reduction \>=1.7 mmol/L)||12.86|0.69|0.142
71885570|NCT02321436|143291367|OTHER|||||||0.6128||||||The Cochran-Mantel-Haenszel (CMH) p-value represents the strength of the association between treatment and global assessments of changes at the last visit, adjusted for symptomatic status at baseline.|Cochran-Mantel-Haenszel|p value significance level = 5%||||||0.6128
71885571|NCT04137887|143291389|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the Confidence intervals (CIs) for relative vaccine effectiveness (rVE); expressed in percentage (%) was more than (\>) 0%.|Relative Vaccine Effectiveness|5.54|||||TWO_SIDED|95.0|-12.43|20.66|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|||20.66|-12.43|
71885572|NCT04137887|143291390|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|5.4|||||TWO_SIDED|95.0|-27.99|30.14|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of respiratory system.||30.14|-27.99|
71945364|NCT00905606|143413879|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.27||||||90.0|94.63|102.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.05|94.63|
71885573|NCT04137887|143291390|SUPERIORITY|Superiority of QIV-HD effectiveness over QIV-SD was demonstrated if the lower bound of the CIs for rVE, expressed in % was \> 0%.|Relative Vaccine Effectiveness|7.09|||||TWO_SIDED|95.0|-15.04|25.0|||||rVE: % reduction of 1st occurrence of cardiovascular/respiratory hospitalization cases in QIV-HD group compared to QIV-SD group. 2-sided 95% CIs for rVE was calculated by exact method assuming Binomial distribution of number of cases in both groups.|Statistical analysis for diseases of circulatory system.||25.00|-15.04|
71885574|NCT01790503|143291414|OTHER||Hazard Ratio (HR)|0.98||||0.456|TWO_SIDED|95.0|0.71|1.36|||Log Rank|||||1.36|0.71|0.456
71885575|NCT01790503|143291414|OTHER||Hazard Ratio (HR)|1.05||||0.619|TWO_SIDED|95.0|0.77|1.43|||Log Rank|||||1.43|0.77|0.619
71885576|NCT01790503|143291414|OTHER||Hazard Ratio (HR)|0.9||||0.272|TWO_SIDED|95.0|0.65|1.26|||Log Rank|||||1.26|0.65|0.272
71885577|NCT01790503|143291415|OTHER|||||||0.44|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.440
71885578|NCT01790503|143291415|OTHER|||||||0.699|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.699
71885579|NCT01790503|143291415|OTHER|||||||0.003|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.003
71885580|NCT01790503|143291415|OTHER|||||||0.201|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.201
71885581|NCT01790503|143291417|OTHER||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.6|1.47|||Log Rank|||||1.47|0.60|0.389
71885582|NCT01790503|143291417|OTHER||Hazard Ratio (HR)|0.94||||0.393|TWO_SIDED|95.0|0.63|1.42|||Log Rank|||||1.42|0.63|0.393
71885583|NCT01790503|143291417|OTHER||Hazard Ratio (HR)|0.98||||0.469|TWO_SIDED|95.0|0.63|1.54|||Log Rank|||||1.54|0.63|0.469
71885584|NCT01790503|143291418|OTHER|||||||0.063|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.063
71823295|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21||||0.012|TWO_SIDED|95.0|1.49|25.83||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction \>=1.7 mmol/L)||25.83|1.49|0.012
71885585|NCT01790503|143291418|OTHER|||||||0.969|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||0.969
71885586|NCT01790503|143291418|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||<0.001
71885587|NCT01790503|143291418|OTHER|||||||0.501|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.501
71885588|NCT01790503|143291419|OTHER|||||||0.705|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years||||0.705
71885589|NCT01790503|143291419|OTHER||||||>|0.999|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection||||>0.999
71885590|NCT01790503|143291419|OTHER|||||||0.099|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100||||0.099
71885591|NCT01790503|143291419|OTHER|||||||0.348|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated||||0.348
71885592|NCT00741156|143291439|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
71885593|NCT02762513|143291442|OTHER||Median overall survival time (months)|9.8|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
71885594|NCT02762513|143291443|OTHER||Median PFS time (months)|3.5|||||TWO_SIDED|95.0|||||||Median calculated by Kaplan-Meier method.|||||
71885595|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|849.0|||<|0.0001|TWO_SIDED|95.0|786.0|921.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||921|786|<0.0001
71885596|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1879.0|||<|0.0001|TWO_SIDED|95.0|1636.0|2112.0||Adjusted Cost Differences in Prescription Drug Costs, nonAEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2112|1636|<0.0001
71885597|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5681.0|||<|0.0001|TWO_SIDED|95.0|5257.0|6077.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||6077|5257|<0.0001
71885598|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|273.0|||<|0.0001|TWO_SIDED|95.0|251.0|295.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||295|251|<0.0001
71885599|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1021.0|||<|0.0001|TWO_SIDED|95.0|819.0|1211.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1211|819|<0.0001
71885600|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|60.0|||<|0.0001|TWO_SIDED|95.0|48.0|72.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||72|48|<0.0001
71945365|NCT00905606|143413880|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.19||||||90.0|94.64|101.87|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.87|94.64|
71885601|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2555.0||||0.008|TWO_SIDED|95.0|834.0|4281.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4281|834|0.0080
71945366|NCT00804856|143413894|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.91||||0.0523|TWO_SIDED|95.0|0.99|8.58|||Regression, Logistic||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|Analysis for Objective Response||8.58|0.99|0.0523
71945367|NCT00804856|143413898|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0208|TWO_SIDED|95.0|0.35|0.92|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||0.92|0.35|0.0208
71945368|NCT00804856|143413899|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0465|TWO_SIDED|95.0|0.4|1.0|||Log Rank||Ratio calculated as Phase II Schedule A Volasertib 350mg+LDAC divided by Phase II Schedule C LDAC.|An exploratory (non-stratified) logrank test was used to compare the different treatment arms.||1.00|0.40|0.0465
71945369|NCT00418561|143413916|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0737|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using analysis of variance (ANOVA) model including the baseline measurement as a covariate.||||0.0737
71945370|NCT00418561|143413917|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1115|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1115
71945371|NCT00418561|143413919|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|TWO_SIDED|||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.||||0.1268
71945372|NCT00829309|143413939|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.45||||||90.0|80.08|121.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||121.03|80.08|
71945373|NCT00829309|143413940|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|90.98||||||90.0|85.23|97.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.12|85.23|
71945374|NCT00829309|143413941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|96.3||||||90.0|85.34|108.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.66|85.34|
71945375|NCT00777023|143413959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.61|STANDARD_ERROR_OF_MEAN|0.53||0.0024|TWO_SIDED|97.5|-2.8|-0.42||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.42|-2.80|0.0024
71945376|NCT00777023|143413959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.52||0.004|TWO_SIDED|97.5|-2.69|-0.33||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4||-0.33|-2.69|0.0040
71945377|NCT00777023|143413960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.51||0.0024|TWO_SIDED|97.5|-2.72|-0.41||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||-0.41|-2.72|0.0024
71945378|NCT00777023|143413960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.51||0.0281|TWO_SIDED|97.5|-2.26|0.02||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12||0.02|-2.26|0.0281
71945379|NCT00777023|143413961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0608|TWO_SIDED|97.5|-0.32|-0.03||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.03|-0.32|0.0608
71945380|NCT00777023|143413961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|97.5|-0.45|-0.11||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4||-0.11|-0.45|0.0003
71945381|NCT00777023|143413962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.028|TWO_SIDED|97.5|-0.43|0.0||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||0.00|-0.43|0.0280
71945382|NCT00777023|143413962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0026|TWO_SIDED|97.5|-0.51|-0.07||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12||-0.07|-0.51|0.0026
71945383|NCT02659150|143413963|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.24||0.26|TWO_SIDED||||||t-test, 2 sided|||Paired T-test comparing values obtained during the follow-up imaging (at 13-18 weeks)minus the baseline values||||0.26
71885602|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4041.0|||<|0.0001|TWO_SIDED|95.0|3776.0|4305.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||4305|3776|<0.0001
71885603|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|105.0|||<|0.0001|TWO_SIDED|95.0|97.0|114.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||114|97|<0.0001
71885604|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|384.0|||<|0.0001|TWO_SIDED|95.0|358.0|413.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||413|358|<0.0001
71885605|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.0|||<|0.0001|TWO_SIDED|95.0|40.0|56.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||56|40|<0.0001
71885606|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|892.0|||<|0.0001|TWO_SIDED|95.0|584.0|1192.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||1192|584|<0.0001
71885607|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12258.0|||<|0.0001|TWO_SIDED|95.0|10482.0|14083.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||14083|10482|<0.0001
71885608|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|322.0|||<|0.0001|TWO_SIDED|95.0|245.0|398.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||398|245|<0.0001
71885609|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|841.0|||<|0.0001|TWO_SIDED|95.0|556.0|1078.0||Adjusted Cost Differences in Prescription Drug Costs, non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1078|556|<0.0001
71885610|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3248.0|||<|0.0001|TWO_SIDED|95.0|2790.0|3714.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3714|2790|<0.0001
71885611|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|164.0|||<|0.0001|TWO_SIDED|95.0|138.0|190.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||190|138|<0.0001
71885612|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|628.0|||<|0.0001|TWO_SIDED|95.0|409.0|819.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||819|409|<0.0001
71885613|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||<|0.0001|TWO_SIDED|95.0|18.0|42.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||42|18|<0.0001
71823296|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.01|||<|0.001|TWO_SIDED|95.0|3.14|54.0||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction \>=1.7 mmol/L)||54.00|3.14|<0.001
71885614|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|235.0||||0.7628|TWO_SIDED|95.0|-1367.0|1798.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1798|-1367|0.7628
71885615|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2306.0|||<|0.0001|TWO_SIDED|95.0|2016.0|2603.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||2603|2016|<0.0001
71885616|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0|||<|0.0001|TWO_SIDED|95.0|52.0|74.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||74|52|<0.0001
71885617|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.0|||<|0.0001|TWO_SIDED|95.0|179.0|245.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||245|179|<0.0001
71945384|NCT02659150|143413964|OTHER||Spearman Correlation Coefficient|0.76||||0.036|TWO_SIDED||||||Spearman|||correlation coefficient||||0.036
71885618|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||<|0.0001|TWO_SIDED|95.0|15.0|33.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||33|15|<0.0001
71885619|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|277.0||||0.0581|TWO_SIDED|95.0|-19.0|581.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||581|-19|0.0581
71885620|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5437.0|||<|0.0001|TWO_SIDED|95.0|3672.0|7142.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7142|3672|<0.0001
71885621|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1019.0|||<|0.0001|TWO_SIDED|95.0|836.0|1191.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1191|836|<0.0001
71885622|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1047.0|||<|0.0001|TWO_SIDED|95.0|564.0|1486.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1486|564|<0.0001
71885623|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9128.0|||<|0.0001|TWO_SIDED|95.0|7346.0|11125.0||Adjusted Cost Differences in Hospitalizations|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||11125|7346|<0.0001
71885624|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|459.0|||<|0.0001|TWO_SIDED|95.0|326.0|622.0||Adjusted Cost Differences in Emergency Department Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||622|326|<0.0001
71885625|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2427.0|||<|0.0001|TWO_SIDED|95.0|1587.0|3290.0||Adjusted Cost Differences in Outpatient Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||3290|1587|<0.0001
71885626|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|357.0|||<|0.0001|TWO_SIDED|95.0|225.0|525.0||Adjusted Cost Differences in Neurologists Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||525|225|<0.0001
71885627|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|502.0|||<|0.0001|TWO_SIDED|95.0|234.0|768.0||Adjusted Cost Differences in Other Healthcare Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||768|234|<0.0001
71885628|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6483.0|||<|0.0001|TWO_SIDED|95.0|5329.0|7927.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||7927|5329|<0.0001
71885629|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|150.0|||<|0.0001|TWO_SIDED|95.0|112.0|199.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||199|112|<0.0001
71823297|NCT00495469|143149756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6||||0.01|TWO_SIDED|95.0|1.56|27.99||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction \>=1.7 mmol/L)||27.99|1.56|0.010
71885630|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|516.0|||<|0.0001|TWO_SIDED|95.0|401.0|645.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||645|401|<0.0001
71885631|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|158.0|||<|0.0001|TWO_SIDED|95.0|97.0|231.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||231|97|<0.0001
71885632|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|83.0|||<|0.0001|TWO_SIDED|95.0|58.0|113.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.|||113|58|<0.0001
71885633|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14582.0|||<|0.0001|TWO_SIDED|95.0|12019.0|17097.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||17097|12019|<0.0001
71885634|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|420.0|||<|0.0001|TWO_SIDED|95.0|210.0|630.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||630|210|<0.0001
71885635|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|658.0|||<|0.0001|TWO_SIDED|95.0|217.0|1131.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||1131|217|<0.0001
71885636|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6040.0|||<|0.0001|TWO_SIDED|95.0|3442.0|8795.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||8795|3442|<0.0001
71885637|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|268.0||||0.002|TWO_SIDED|95.0|81.0|425.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||425|81|0.0020
71885638|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.967|TWO_SIDED|95.0|-991.0|944.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||944|-991|0.9670
71885639|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.0||||0.2563|TWO_SIDED|95.0|-77.0|302.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||302|-77|0.2563
71885640|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|328.0||||0.01|TWO_SIDED|95.0|90.0|588.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||588|90|0.0100
71885641|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4984.0|||<|0.0001|TWO_SIDED|95.0|3168.0|7335.0||Adjusted Cost Differences in Hospitalizations, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||7335|3168|<0.0001
71885642|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|112.0|||<|0.0001|TWO_SIDED|95.0|70.0|166.0||Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||166|70|<0.0001
71885643|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|236.0||||0.01|TWO_SIDED|95.0|70.0|403.0||Adjusted Cost Differences in Outpatient Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||403|70|0.01
71885644|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.0||||0.1061|TWO_SIDED|95.0|-22.0|145.0||Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||145|-22|0.1061
71885645|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.0|||<|0.0001|TWO_SIDED|95.0|28.0|93.0||Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||93|28|<0.0001
71885646|NCT01390909|143291448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7673.0|||<|0.0001|TWO_SIDED|95.0|4571.0|10989.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.||||10989|4571|<0.0001
71885647|NCT03806127|143291484|OTHER||Cochran-Mantel-Haenszel (CMH) Difference|-1.9|||||TWO_SIDED|90.0|-16.1|12.3|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||12.3|-16.1|
71885648|NCT03806127|143291485|OTHER||CMH Difference|9.1|||||TWO_SIDED|90.0|-4.8|22.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-D Participants||22.9|-4.8|
71885649|NCT03806127|143291485|OTHER||CMH Difference|-0.1|||||TWO_SIDED|90.0|-16.7|16.4|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|IBS-M Participants||16.4|-16.7|
71885650|NCT03806127|143291485|OTHER||CMH Difference|5.3|||||TWO_SIDED|90.0|-5.4|15.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|All Participants||15.9|-5.4|
71885651|NCT03806127|143291486|OTHER||CMH Difference|1.6|||||TWO_SIDED|90.0|-11.7|14.9|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus \>= 6) strata, with weights proposed by Greenland and Robins.|||14.9|-11.7|
71945385|NCT02659150|143413965|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.32||0.14|TWO_SIDED||||||t-test, 2 sided|||The carotid artery plaque with highest FDG uptake is located using Positron Emission Tomography/ Magnetic Resonance Imaging images. Thereafter Paired T- Test is used to compare baseline vs follow-up values of FDG uptake (before vs after 12 weeks of tocilizumab treatment). FDG uptake is assessed as a Target to background values (TBR) , which is calculated as the mean arterial standardized uptake value (SUV) divided by background blood pool SUV.||||0.14
71945386|NCT02659150|143413966|SUPERIORITY||correlation coefficient|-0.66||||0.076|TWO_SIDED||||||Spearman's Method|||||||0.076
71945387|NCT02659150|143413967|SUPERIORITY||Correlation coefficient|0.67||||0.07|TWO_SIDED||||||Spearman's Method|||||||0.07
71945388|NCT05342597|143414011|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.025|||||TWO_SIDED|90.0|0.931|1.128|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.128|0.931|
71885652|NCT03806127|143291487|OTHER||CMH Difference|6.7|||||TWO_SIDED|90.0|-5.5|18.8|||||Difference in proportion and corresponding confidence interval were calculated using the CMH risk difference estimate stratified by randomized Baseline abdominal pain (\< 6 versus ≥ 6) strata, with weights proposed by Greenland and Robins.|||18.8|-5.5|
71885653|NCT05218499|143291507|OTHER||Hazard Ratio (HR)|0.79||||0.0956|TWO_SIDED|95.0|0.6|1.06|||Regression, Cox||A hazard ratio value below 1 favors brigimadlin.|The primary estimator for the hazard ratio is the median unbiased estimator. The confidence interval (CI) for the hazard ratio is calculated as a repeated CI. The p-value is obtained using a weighted inverse normal method combining one-sided p-values from two stages.||1.06|0.60|0.0956
71885654|NCT05218499|143291508|OTHER||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.52|5.67|||||An odds ratio value greater than 1 favors brigimadlin.|The primary estimator and CI for the odds ratio is by Cochran-Mantel-Haenszel.||5.67|1.52|
71885655|NCT05218499|143291510|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.81|2.82|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate.||2.82|0.81|
71885656|NCT05218499|143291510|OTHER||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.48|4.84|||||An odds ratio value greater than 1 favors brigimadlin.|Odds ratios are calculated from a logistic regression model with the stratification factor (locally advanced vs. metastatic) included as a covariate. Exact 95% confidence interval (CI) by Clopper and Pearson.||4.84|1.48|
71885657|NCT03237065|143291548|SUPERIORITY||Risk Difference (RD)|-65.8|||<|0.0001|TWO_SIDED|95.0|-76.6|-49.8|||Cochran-Mantel-Haenszel|Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.|Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-49.8|-76.6|<0.0001
71885658|NCT03237065|143291549|SUPERIORITY|||||||0.0511|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan- Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.0511
71885659|NCT03237065|143291550|SUPERIORITY||Risk Difference (RD)|-44.6|||<|0.0001|TWO_SIDED|95.0|-57.7|-31.6|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-31.6|-57.7|<0.0001
71885660|NCT03237065|143291551|SUPERIORITY||Mean Difference (Final Values)|0.46|||<|0.0001|TWO_SIDED|95.0|0.3|0.62|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.62|0.30|<0.0001
71885661|NCT03237065|143291551|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.32|0.76|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.32|<0.0001
71885662|NCT03237065|143291551|SUPERIORITY||Mean Difference (Final Values)|0.73|||<|0.0001|TWO_SIDED|95.0|0.49|0.96|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.96|0.49|<0.0001
71885663|NCT03237065|143291551|SUPERIORITY||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.99|1.46|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.46|0.99|<0.0001
71885664|NCT03237065|143291551|SUPERIORITY||Mean Difference (Final Values)|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.51|0.98|<0.0001
71885665|NCT03237065|143291551|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.91|1.43|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.43|0.91|<0.0001
71885666|NCT03237065|143291552|SUPERIORITY||Mean Difference (Final Values)|13.99|||<|0.0001|TWO_SIDED|95.0|9.38|18.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||18.59|9.38|<0.0001
71885667|NCT03237065|143291552|SUPERIORITY||Mean Difference (Final Values)|15.84|||<|0.0001|TWO_SIDED|95.0|9.45|22.23|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.23|9.45|<0.0001
71885668|NCT03237065|143291552|SUPERIORITY||Mean Difference (Final Values)|21.66|||<|0.0001|TWO_SIDED|95.0|14.72|28.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.59|14.72|<0.0001
71885669|NCT03237065|143291552|SUPERIORITY||Mean Difference (Final Values)|36.17|||<|0.0001|TWO_SIDED|95.0|29.28|43.06|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.06|29.28|<0.0001
71885670|NCT03237065|143291552|SUPERIORITY||Mean Difference (Final Values)|37.86|||<|0.0001|TWO_SIDED|95.0|29.99|45.72|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.72|29.99|<0.0001
71885671|NCT03237065|143291552|SUPERIORITY||Mean Difference (Final Values)|34.53|||<|0.0001|TWO_SIDED|95.0|26.8|42.26|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||42.26|26.80|<0.0001
71885672|NCT03237065|143291554|SUPERIORITY||Mean Difference (Final Values)|-96.8|||<|0.0001|TWO_SIDED|95.0|-119.8|-73.8|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-73.8|-119.8|<0.0001
71885673|NCT03237065|143291554|SUPERIORITY||Mean Difference (Final Values)|-15.7||||0.1064|TWO_SIDED|95.0|-34.9|3.4|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.4|-34.9|0.1064
71885674|NCT03237065|143291554|SUPERIORITY||Mean Difference (Final Values)|-251.7|||<|0.0001|TWO_SIDED|95.0|-307.2|-196.2|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-196.2|-307.2|<0.0001
71885675|NCT03237065|143291554|SUPERIORITY||Mean Difference (Final Values)|-79.1|||<|0.0001|TWO_SIDED|95.0|-103.7|-54.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.5|-103.7|<0.0001
71885676|NCT03237065|143291554|SUPERIORITY||Mean Difference (Final Values)|-61.8|||<|0.0001|TWO_SIDED|95.0|-83.0|-40.5|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.5|-83.0|<0.0001
71885677|NCT03237065|143291554|SUPERIORITY||Mean Difference (Final Values)|-18.0||||0.0039|TWO_SIDED|95.0|-30.1|-5.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.9|-30.1|0.0039
71823298|NCT00495469|143149757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.318|TWO_SIDED|95.0|-0.19|0.59||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.59|-0.19|0.318
71885678|NCT03237065|143291555|SUPERIORITY||Mean Difference (Final Values)|-57.5||||0.1243|TWO_SIDED|95.0|-131.1|16.1|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.1|-131.1|0.1243
71885679|NCT03237065|143291555|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.5547|TWO_SIDED|95.0|-49.7|91.0|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||91.0|-49.7|0.5547
71885680|NCT03237065|143291555|SUPERIORITY||Mean Difference (Final Values)|-155.7||||0.0005|TWO_SIDED|95.0|-234.7|-76.6|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-76.6|-234.7|0.0005
71885681|NCT03237065|143291555|SUPERIORITY||Mean Difference (Final Values)|-27.3||||0.3516|TWO_SIDED|95.0|-86.0|31.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||31.5|-86.0|0.3516
71885682|NCT03237065|143291555|SUPERIORITY||Mean Difference (Final Values)|-24.3||||0.1988|TWO_SIDED|95.0|-62.3|13.7|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.7|-62.3|0.1988
71885683|NCT03237065|143291555|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.4379|TWO_SIDED|95.0|-18.6|41.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.2|-18.6|0.4379
71885684|NCT03237065|143291556|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.6869|TWO_SIDED|95.0|-1.06|0.7|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.70|-1.06|0.6869
71885685|NCT03237065|143291556|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.1037|TWO_SIDED|95.0|-2.29|0.22|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.22|-2.29|0.1037
71885686|NCT03237065|143291556|SUPERIORITY||Mean Difference (Final Values)|-1.62||||0.0213|TWO_SIDED|95.0|-2.99|-0.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.25|-2.99|0.0213
71885687|NCT03237065|143291556|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.0176|TWO_SIDED|95.0|-3.47|-0.34|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.34|-3.47|0.0176
71945389|NCT05342597|143414011|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.959|||||TWO_SIDED|90.0|0.871|1.056|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.056|0.871|
71945390|NCT05342597|143414011|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.827|1.002|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.002|0.827|
71885688|NCT03237065|143291556|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.0999|TWO_SIDED|95.0|-3.01|0.27|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.27|-3.01|0.0999
71885689|NCT03237065|143291556|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.8878|TWO_SIDED|95.0|-1.77|2.04|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-1.77|0.8878
71885690|NCT03237065|143291557|SUPERIORITY||Mean Difference (Final Values)|21.81|||<|0.0001|TWO_SIDED|95.0|17.66|25.95|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||25.95|17.66|<0.0001
71885691|NCT03237065|143291557|SUPERIORITY||Mean Difference (Final Values)|4.64||||0.2923|TWO_SIDED|95.0|-4.05|13.33|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||13.33|-4.05|0.2923
71885692|NCT03237065|143291557|SUPERIORITY||Mean Difference (Final Values)|19.56|||<|0.0001|TWO_SIDED|95.0|12.37|26.74|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||26.74|12.37|<0.0001
71885693|NCT03237065|143291557|SUPERIORITY||Mean Difference (Final Values)|33.05|||<|0.0001|TWO_SIDED|95.0|25.96|40.14|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||40.14|25.96|<0.0001
71885694|NCT03237065|143291557|SUPERIORITY||Mean Difference (Final Values)|21.82|||<|0.0001|TWO_SIDED|95.0|14.2|29.43|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.43|14.20|<0.0001
71885695|NCT03237065|143291557|SUPERIORITY||Mean Difference (Final Values)|9.03||||0.025|TWO_SIDED|95.0|1.16|16.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||16.90|1.16|0.0250
71885696|NCT03237065|143291558|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.5134|TWO_SIDED|95.0|-0.22|0.11|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.11|-0.22|0.5134
71885697|NCT03237065|143291558|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7579|TWO_SIDED|95.0|-0.24|0.32|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.32|-0.24|0.7579
71885698|NCT03237065|143291558|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3169|TWO_SIDED|95.0|-0.41|0.14|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|-0.41|0.3169
71885699|NCT03237065|143291558|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.0018|TWO_SIDED|95.0|-0.76|-0.18|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.18|-0.76|0.0018
71885700|NCT03237065|143291558|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0003|TWO_SIDED|95.0|-0.77|-0.24|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.24|-0.77|0.0003
71885701|NCT03237065|143291558|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1063|TWO_SIDED|95.0|-0.5|0.05|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.50|0.1063
71885702|NCT03237065|143291559|SUPERIORITY||Mean Difference (Final Values)|4.57||||0.2166|TWO_SIDED|95.0|-2.72|11.85|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.85|-2.72|0.2166
71885703|NCT03237065|143291559|SUPERIORITY||Mean Difference (Final Values)|-4.64||||0.2997|TWO_SIDED|95.0|-13.47|4.19|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.19|-13.47|0.2997
71885704|NCT03237065|143291559|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.9221|TWO_SIDED|95.0|-7.75|8.56|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||8.56|-7.75|0.9221
71885705|NCT03237065|143291559|SUPERIORITY||Mean Difference (Final Values)|-15.69||||0.0034|TWO_SIDED|95.0|-26.07|-5.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-5.32|-26.07|0.0034
71885706|NCT03237065|143291559|SUPERIORITY||Mean Difference (Final Values)|-22.54||||0.0002|TWO_SIDED|95.0|-33.93|-11.16|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-11.16|-33.93|0.0002
71885707|NCT03237065|143291559|SUPERIORITY||Mean Difference (Final Values)|-24.81|||<|0.0001|TWO_SIDED|95.0|-35.42|-14.21|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-14.21|-35.42|<0.0001
71885708|NCT03237065|143291560|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.3048|TWO_SIDED|95.0|-0.1|0.03|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.03|-0.10|0.3048
71885709|NCT03237065|143291560|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1641|TWO_SIDED|95.0|-0.02|0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.13|-0.02|0.1641
71885710|NCT03237065|143291560|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.1333|TWO_SIDED|95.0|-0.02|0.12|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.02|0.1333
71885711|NCT03237065|143291560|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.9385|TWO_SIDED|95.0|-0.17|0.16|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.16|-0.17|0.9385
71885712|NCT03237065|143291560|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0408|TWO_SIDED|95.0|0.0|0.14|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.14|0.00|0.0408
71885713|NCT03237065|143291560|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.2376|TWO_SIDED|95.0|-0.03|0.12|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.12|-0.03|0.2376
71885714|NCT03237065|143291562|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.0882|TWO_SIDED|95.0|-0.67|0.05|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.05|-0.67|0.0882
71885715|NCT03237065|143291562|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0941|TWO_SIDED|95.0|-0.74|0.06|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.06|-0.74|0.0941
71885716|NCT03237065|143291562|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.0628|TWO_SIDED|95.0|-0.02|0.66|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.66|-0.02|0.0628
71885717|NCT03237065|143291562|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.0056|TWO_SIDED|95.0|0.14|0.79|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.79|0.14|0.0056
71885718|NCT03237065|143291562|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.0492|TWO_SIDED|95.0|0.0|0.55|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.55|0.00|0.0492
71701108|NCT02469233|142918222|SUPERIORITY||Time by treatment interaction coeff.|-1.45||||0.43|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.43
71885719|NCT03237065|143291562|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0882|TWO_SIDED|95.0|-0.05|0.64|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.64|-0.05|0.0882
71885720|NCT03237065|143291563|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.6568|TWO_SIDED|95.0|-35.3|22.3|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.3|-35.3|0.6568
71885721|NCT03237065|143291563|SUPERIORITY||Mean Difference (Final Values)|-24.2||||0.4929|TWO_SIDED|95.0|-94.0|45.5|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||45.5|-94.0|0.4929
71945391|NCT05342597|143414011|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.801|||||TWO_SIDED|90.0|0.712|0.901|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.901|0.712|
71701109|NCT02469233|142918222|SUPERIORITY||Time by treatment interaction coeff.|-1.55||||0.4|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||SE variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.40
71885722|NCT03237065|143291563|SUPERIORITY||Mean Difference (Final Values)|-91.7||||0.0113|TWO_SIDED|95.0|-162.3|-21.1|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-21.1|-162.3|0.0113
71885723|NCT03237065|143291563|SUPERIORITY||Mean Difference (Final Values)|-240.4|||<|0.0001|TWO_SIDED|95.0|-318.4|-162.3|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-162.3|-318.4|<0.0001
71885724|NCT03237065|143291563|SUPERIORITY||Mean Difference (Final Values)|-135.1|||<|0.0001|TWO_SIDED|95.0|-196.1|-74.0|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-74.0|-196.1|<0.0001
71885725|NCT03237065|143291563|SUPERIORITY||Mean Difference (Final Values)|-67.7||||0.0039|TWO_SIDED|95.0|-113.2|-22.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-22.2|-113.2|0.0039
71885726|NCT03237065|143291564|SUPERIORITY||Mean Difference (Final Values)|24.2||||0.0503|TWO_SIDED|95.0|0.0|48.5|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||48.5|-0.0|0.0503
71885727|NCT03237065|143291564|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.5794|TWO_SIDED|95.0|-5.5|9.8|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.8|-5.5|0.5794
71885728|NCT03237065|143291564|SUPERIORITY||Mean Difference (Final Values)|-62.2|||<|0.0001|TWO_SIDED|95.0|-70.1|-54.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-54.3|-70.1|<0.0001
71885729|NCT03237065|143291564|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0001|TWO_SIDED|95.0|-10.4|-3.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-3.5|-10.4|0.0001
71885730|NCT03237065|143291564|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0008|TWO_SIDED|95.0|-9.1|-2.4|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-2.4|-9.1|0.0008
71945392|NCT05342597|143414012|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|1.083|||||TWO_SIDED|90.0|0.821|1.429|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.429|0.821|
71885731|NCT03237065|143291564|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.004|TWO_SIDED|95.0|-8.1|-1.6|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.6|-8.1|0.0040
71885732|NCT03237065|143291565|SUPERIORITY||Risk Difference (RD)|-10.7||||0.009|TWO_SIDED|95.0|-18.8|-2.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-2.6|-18.8|0.0090
71885733|NCT01764633|143291653|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.0001|TWO_SIDED|95.0|0.79|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|The primary endpoint was compared between treatment groups at a significance level of 0.05.||0.92|0.79|< 0.0001
71885734|NCT01764633|143291654|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.73|0.88|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.||0.88|0.73|< 0.0001
71885735|NCT01764633|143291655|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6188|TWO_SIDED|95.0|0.88|1.25|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.||1.25|0.88|0.6188
71885736|NCT01764633|143291656|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5368|TWO_SIDED|95.0|0.91|1.19|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.||1.19|0.91|0.5368
71885737|NCT01764633|143291657|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.82|0.65|< 0.0001
71885738|NCT01764633|143291658|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0101|TWO_SIDED|95.0|0.66|0.95|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.95|0.66|0.0101
71885739|NCT01764633|143291659|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.71|0.86|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.86|0.71|< 0.0001
71885740|NCT01764633|143291660|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8179|TWO_SIDED|95.0|0.86|1.13|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||1.13|0.86|0.8179
71885741|NCT01764633|143291661|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0035|TWO_SIDED|95.0|0.65|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.||0.92|0.65|0.0035
71885742|NCT04781816|143291666|SUPERIORITY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.53|||TWO_SIDED|90.0|-18.26|6.85||||||Analysis was performed using mixed model with repeated measurements (MMRM) including fixed effects for baseline CLASI-A, post-baseline visit, geographical region, disease subtype, baseline use of CQ/HCQ, intervention group, visit-by- intervention group interaction, and visit-by-baseline-CLASI-A interaction.||6.85|-18.26|
71885743|NCT01100944|143291694|SUPERIORITY_OR_OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71885744|NCT01100944|143291703|SUPERIORITY_OR_OTHER|||||||0.3||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.30
71885745|NCT01100944|143291703|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
71885746|NCT01100944|143291703|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
71885747|NCT01100944|143291704|SUPERIORITY_OR_OTHER|||||||0.76||||||Fold change at Cycle 2 Day 1 vs. pre was assessed.Only differences with p\<0.005 could be potentially considered statistically significant while those with 0.005\<p\<0.05 would represent trends towards a difference.|Wilcoxon signed rank test|||||||0.76
71885748|NCT01100944|143291704|SUPERIORITY_OR_OTHER|||||||0.0009||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0009
71885749|NCT01100944|143291704|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
71885750|NCT01100944|143291705|SUPERIORITY_OR_OTHER|||||||0.95||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.95
71885751|NCT01100944|143291705|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
71885752|NCT01100944|143291705|SUPERIORITY_OR_OTHER|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test|||||||0.0001
71885753|NCT02499029|143291810|SUPERIORITY|||||||0.05|||||||Regression, Linear|||A series of hierarchical linear regression analyses were conducted to examine the effects of treatment group (NAC or placebo) on PTSD symptomatology, craving, substance use, and depression. Baseline levels of the respective outcome measures were entered in Step 1 of the model to adjust for any baseline differences. Treatment group was entered as the predictor in Step 2. The significance threshold was set at a p-value of .05 (two-sided) for all statistical tests.||||.05
71885754|NCT03889639|143291821|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95 percentage (%) confidence interval (CI) were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-56.16||||0.1673|TWO_SIDED|95.0|-193.99|17.05|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||17.05|-193.99|0.1673
71885755|NCT03889639|143291821|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.8||||0.354|TWO_SIDED|95.0|-356.24|41.91|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||41.91|-356.24|0.3540
71885756|NCT03889639|143291821|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|13.49||||0.7674|TWO_SIDED|95.0|-126.05|66.89|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||66.89|-126.05|0.7674
71885757|NCT03889639|143291821|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|85.02||||0.0178|TWO_SIDED|95.0|28.02|96.88|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.88|28.02|0.0178
71885758|NCT03889639|143291822|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|10.17||||0.7736|TWO_SIDED|95.0|-86.49|56.73|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||56.73|-86.49|0.7736
71885759|NCT03889639|143291822|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|37.07||||0.248|TWO_SIDED|95.0|-38.08|71.32|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||71.32|-38.08|0.2480
71885760|NCT03889639|143291822|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|38.5||||0.3081|TWO_SIDED|95.0|-56.61|75.85|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||75.85|-56.61|0.3081
71885761|NCT03889639|143291822|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model without adjusting for Baseline T2 lesion activity as all participants had at least one T2 lesion at Baseline.|Relative reduction in lesions|89.34||||0.0001|TWO_SIDED|95.0|68.39|96.41|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||96.41|68.39|0.0001
71885762|NCT03889639|143291823|SUPERIORITY|Relative reduction in lesions in SAR442168 5 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-62.16||||0.1525|TWO_SIDED|95.0|-214.44|16.38|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 5 mg/Placebo||16.38|-214.44|0.1525
71885763|NCT03889639|143291823|SUPERIORITY|Relative reduction in lesions in SAR442168 15 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|-47.38||||0.4606|TWO_SIDED|95.0|-312.91|47.4|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 15 mg/Placebo||47.40|-312.91|0.4606
71885764|NCT03889639|143291823|SUPERIORITY|Relative reduction in lesions in SAR442168 30 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|2.9||||0.949|TWO_SIDED|95.0|-138.96|60.54|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 30 mg/Placebo||60.54|-138.96|0.9490
71885765|NCT03889639|143291823|SUPERIORITY|Relative reduction in lesions in SAR442168 60 mg (Cohorts 1 and 2) when compared with placebo (Cohort 2) with 95% CI were reported. Analysis was performed using a negative binomial regression model adjusted for Baseline gadolinium-enhancing T1-hyperintense lesion activity (presence/absence).|Relative reduction in lesions|65.05||||0.2324|TWO_SIDED|95.0|-96.21|93.77|||Negative binomial regression model|Threshold for significance for p-value was 0.05.||SAR442168 60 mg/Placebo||93.77|-96.21|0.2324
71823299|NCT00495469|143149757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.131|TWO_SIDED|95.0|-0.73|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.73|0.131
71885766|NCT01849770|143291834|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.4||0.561|TWO_SIDED|95.0|-1.03|0.56|||Random slopes model|||||0.56|-1.03|0.561
71885767|NCT01849770|143291834|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.43||0.662|TWO_SIDED|95.0|-1.04|0.66|||Random slopes model|||||0.66|-1.04|0.662
71885768|NCT01849770|143291835|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.71|STANDARD_ERROR_OF_MEAN|1.25||0.178|TWO_SIDED|95.0|-0.8|4.22|||Random slopes model|||||4.22|-0.80|0.178
71885769|NCT01849770|143291835|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.94|STANDARD_ERROR_OF_MEAN|1.42||0.51|TWO_SIDED|95.0|-3.8|1.91|||Random slopes model|||||1.91|-3.80|0.510
71885770|NCT03506295|143291856|OTHER||Odds Ratio (OR)|0.496||||0.7878|TWO_SIDED|95.0|0.168|1.469|||Regression, Logistic|||||1.469|0.168|0.7878
71885771|NCT02682901|143291884|SUPERIORITY|||||||0.603||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.603
71885772|NCT02682901|143291885|SUPERIORITY|||||||0.068||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.068
71885773|NCT02682901|143291886|SUPERIORITY|||||||0.493||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means are statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.493
71885774|NCT02682901|143291887|SUPERIORITY|||||||0.524||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.524
71885775|NCT02682901|143291888|SUPERIORITY|||||||0.63||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.630
71885776|NCT02682901|143291889|SUPERIORITY|||||||0.537||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.537
71885777|NCT02682901|143291890|SUPERIORITY|||||||0.53||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.530
71885778|NCT02682901|143291891|SUPERIORITY|||||||0.005||||||Between treatment group (bromocriptine-QR vs. placebo) differences in change from baseline to week 24 was analyzed using Independent Samples T-tests. Means were statistically significantly different at the 5% level (P \< 0.05) two-sided.|t-test, 2 sided|||||||0.005
71885779|NCT03694925|143291893|OTHER||Specificity|0.871|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
71885780|NCT03694925|143291893|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the true negatives and the denominator is the number of total negatives.|||||
71885781|NCT03694925|143291893|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
71885782|NCT03694925|143291893|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of true positives over the number of total positives.|||||
71885783|NCT03694925|143291893|OTHER||Positive predictive value|0.852|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
71885784|NCT03694925|143291893|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
71885785|NCT03694925|143291893|OTHER||Negative predictive value|0.984|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
71885786|NCT03694925|143291893|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
71885787|NCT03694925|143291894|OTHER||Specificity|0.829|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
71885788|NCT03694925|143291894|OTHER||Specificity|0.957|||||TWO_SIDED||||||||Specificity was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the number of the number of aseptic negatives and the denominator is the number of aseptics.|||||
71885789|NCT03694925|143291894|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>14 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
71885790|NCT03694925|143291894|OTHER||Sensitivity|0.981|||||TWO_SIDED||||||||Sensitivity was calculated using 2x2 tables using \>50 mg/L cut off. Sensitivity is the number of septic positives over the number of septics.|||||
71885791|NCT03694925|143291894|OTHER||Positive predictive value|0.813|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
71885792|NCT03694925|143291894|OTHER||Positive predictive value|0.945|||||TWO_SIDED||||||||Positive predictive value was calculated using 2x2 tables using \>50mg/L cut off. The numerator is the septic positives and the denominator are the total positives.|||||
71885793|NCT03694925|143291894|OTHER||Negative predictive value|0.983|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>14 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.|||||
71885794|NCT03694925|143291894|OTHER||Negative predictive value|0.985|||||TWO_SIDED||||||||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. The numerator is the aseptic negatives and the denominator is the number of total negatives.||Negative predictive value was calculated using 2x2 tables using \>50 mg/L cut off. NPV=98.5%|||
71885795|NCT02799069|143291896|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.0|||||ONE_SIDED|97.5|5.9||||||||||5.9|
71885796|NCT02799069|143291896|SUPERIORITY||Difference to BF-200 ALA|61.1||||0|TWO_SIDED|95.0|51.2|71.0|||Chi-squared|||"Superiority of BF-200 ALA compared to placebo:~A sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05."||71.0|51.2|0.0000
71885797|NCT02799069|143291897|NON_INFERIORITY|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.2|||||ONE_SIDED|97.5|6.0||||||||||6.0|
71885798|NCT02799069|143291897|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|59.4||||0|TWO_SIDED|95.0|48.4|70.4|||Chi-squared|||||70.4|48.4|0.0000
71885799|NCT02799069|143291898|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|72.0||||0|TWO_SIDED|95.0|59.7|84.2|||Chi-squared|||||84.2|59.7|0.0000
71885800|NCT02799069|143291898|SUPERIORITY_OR_OTHER||Difference to BF-200 ALA|17.3|||||ONE_SIDED|97.5|6.6||||||||||6.6|
71885801|NCT03434977|143291982|OTHER||Ratio|0.937|||||TWO_SIDED|90.0|0.89|0.986||||||The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.||0.986|0.890|
71885802|NCT03434977|143291983|OTHER||LS-Means Difference|0.9083|||||TWO_SIDED|90.0|0.1821|1.6345||||||The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.||1.6345|0.1821|
71885803|NCT03434977|143291984|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.943|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.943|
71885804|NCT03434977|143291985|OTHER||Ratio|0.997|||||TWO_SIDED|90.0|0.942|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.||1.056|0.942|
71885805|NCT03434977|143291986|OTHER||Ratio|0.985|||||TWO_SIDED|90.0|0.932|1.041||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.||1.041|0.932|
71885806|NCT03434977|143291987|OTHER||Ratio|1.047|||||TWO_SIDED|90.0|1.006|1.091||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.091|1.006|
71885807|NCT03434977|143291988|OTHER||Ratio|1.037|||||TWO_SIDED|90.0|0.996|1.081||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.||1.081|0.996|
71885808|NCT03434977|143291989|OTHER||Ratio|1.014|||||TWO_SIDED|90.0|0.959|1.071||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.||1.071|0.959|
71885809|NCT03434977|143291990|OTHER||Ratio|1.003|||||TWO_SIDED|90.0|0.947|1.062||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.||1.062|0.947|
71885810|NCT03434977|143291991|OTHER||Ratio|0.989|||||TWO_SIDED|90.0|0.916|1.068||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.||1.068|0.916|
71885811|NCT00217087|143291997|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED||||||Fisher Exact|||||||0.0098
71885812|NCT00217087|143291998|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Chi-squared|||||||0.34
71885813|NCT00217087|143291999|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus.||||||0.2
71885814|NCT05574062|143292001|NON_INFERIORITY|-7.5% non-inferiority margin|Mean Difference (Final Values)|9.88|||||TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|
71885815|NCT05574062|143292002|NON_INFERIORITY|non-inferiority margin of 0.4% HbA1c|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (continuation phase period1) values|||0.31|-0.03|
71885816|NCT05574062|143292003|NON_INFERIORITY|non- inferiority margin of 0.4%|Mean Difference (Final Values)|-0.61|||||TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|
71885817|NCT05574062|143292004|SUPERIORITY||Median Difference (Final Values)|9.88|||<|0.0001|TWO_SIDED|95.0|8.04|11.72|||Mixed Models Analysis||Mixed model adjusted for baseline (run-in) values|||11.72|8.04|<.0001
71885818|NCT05574062|143292005|SUPERIORITY||Mean Difference (Net)|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Mixed Models Analysis||Mixed model adjusted for baseline (screening) values|||-0.46|-0.76|<.0001
71885819|NCT05574062|143292006|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.1097|TWO_SIDED|95.0|-0.03|0.31|||Regression, Linear||Linear regression model adjusted for baseline (period1) values|||0.31|-0.03|0.1097
71885820|NCT05574062|143292007|NON_INFERIORITY|non inferiority margin of -7.5%|Mean Difference (Net)|1.17|||||TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|
71885821|NCT05574062|143292008|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.0581|TWO_SIDED|95.0|-0.04|2.38|||Regression, Linear||Linear regression adjusted for baseline (continuation phase period 1) values|||2.38|-0.04|0.0581
71885822|NCT04770779|143292022|SUPERIORITY||Common Risk Difference on Response Rate|17.6||||0.0003|TWO_SIDED|95.0|8.0|27.2|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||27.2|8.0|0.0003
71885823|NCT04770779|143292023|SUPERIORITY||Common Risk Difference on Response Rate|11.1||||0.0003|TWO_SIDED|95.0|5.1|17.0|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||17.0|5.1|0.0003
71885824|NCT04770779|143292024|SUPERIORITY||Common Risk Difference on Response Rate|13.4|||<|0.0001|TWO_SIDED|95.0|7.7|19.1|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||19.1|7.7|<0.0001
71885825|NCT04770779|143292025|SUPERIORITY||Common Risk Difference on Response Rate|6.4||||0.0056|TWO_SIDED|95.0|1.9|10.9|||Mantel Haenszel|||The p-value is based on the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors.||10.9|1.9|0.0056
71885826|NCT03692052|143292064|OTHER||||||<|0.0001|||||||Clopper-Pearson Method|Significance of p-value associated with the test of H0:Hb response rate =0.3 vs H1:Hb response rate \> 0.3.||||||<.0001
71885827|NCT06232317|143292095|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||||||0.61
71885828|NCT06232317|143292096|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
71885829|NCT06232317|143292101|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71885830|NCT05600309|143292102|OTHER||Hazard Ratio (HR)|0.94||||0.3914|TWO_SIDED|95.0|0.59|1.5||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.59|0.3914
71885831|NCT05600309|143292103|OTHER||Hazard Ratio (HR)|1.23||||0.8091|TWO_SIDED|95.0|0.78|1.92||One-sided nominal p-value based on log-rank test.|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.92|0.78|0.8091
71885832|NCT05600309|143292104|OTHER||Difference in percentage|6.0||||0.0502|TWO_SIDED|95.0|-2.3|16.3||One-sided nominal p-value for testing.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|||16.3|-2.3|0.0502
71885833|NCT03505021|143292147|SUPERIORITY||Mean Difference (Final Values)|0.258||||0.8253|TWO_SIDED|95.0|-2.032|2.547|||ANCOVA|||||2.547|-2.032|0.8253
71885834|NCT03505021|143292148|SUPERIORITY||Mean Difference (Final Values)|10.69||||0.4277|TWO_SIDED|95.0|-15.74|37.12|||ANCOVA|||||37.12|-15.74|0.4277
71885835|NCT03505021|143292149|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6733|TWO_SIDED|95.0|0.833|1.327|||Regression, Cox|||||1.327|0.833|0.6733
71885836|NCT03505021|143292150|SUPERIORITY||Mean Difference (Final Values)|3.762||||0.1295|TWO_SIDED|95.0|-1.129|8.654|||ANCOVA|||||8.654|-1.129|0.1295
71885837|NCT03505021|143292151|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.623|TWO_SIDED|95.0|-0.04|0.066|||Mixed Models Analysis|||||0.066|-0.040|0.6230
71885838|NCT03505021|143292152|SUPERIORITY||Mean Difference (Final Values)|-0.272||||0.1752|TWO_SIDED|95.0|-0.666|0.122|||ANCOVA|||||0.122|-0.666|0.1752
71885839|NCT02392429|143292165|NON_INFERIORITY|we tested the null hypothesis that the NPV of the post-treatment FLT PET/CT scan was less than or equal to the NPV of the day 14 nadir bone marrow biopsy (estimated to be 0.64 by Hussein et al) against the one-sided alternative hypothesis that the NPV was greater than 0.64 using the exact binomial test.|||||>|0.99|||||||binomial exact test|||||||>0.99
71885840|NCT02392429|143292166|NON_INFERIORITY|we tested the null hypothesis that the PPV of the post-treatment FLT PET/CT scan was less than or equal to the PPV of the day 14 nadir bone marrow biopsy (estimated to be 0.79by Hussein et al) against the one-sided alternative hypothesis that the PPV was greater than 0.79 using the exact binomial test.||||||0.06|||||||binomial exact test|||||||0.06
71885841|NCT02392429|143292170|EQUIVALENCE|no margin was assumed||||||0.68|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.68
71885842|NCT02392429|143292171|EQUIVALENCE|no margin was assumed||||||0.08|||||||log-rank test|||Kaplan-Meier curves were constructed for the positive and negative scan groups, and the null hypothesis that the survival distributions of the two groups were equal was tested using the log-rank test.||||0.08
71885843|NCT04183335|143292188|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.0001|TWO_SIDED|95.0|2.78|15.41||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||15.41|2.78|<0.0001
71885844|NCT04183335|143292189|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0004|TWO_SIDED|95.0|1.81|8.98||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||8.98|1.81|0.0004
71885845|NCT04183335|143292190|SUPERIORITY||Odds Ratio (OR)|6.9|||<|0.0001|TWO_SIDED|95.0|2.49|19.05||Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||19.05|2.49|<0.0001
71885846|NCT04183335|143292191|SUPERIORITY||LS mean difference|-26.67|||<|0.0001|TWO_SIDED|95.0|-38.44|-14.9||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-14.90|-38.44|<0.0001
71885847|NCT04183335|143292192|SUPERIORITY||Least square mean difference|-6.19|||<|0.0001|TWO_SIDED|95.0|-8.34|-4.05||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.05|-8.34|<0.0001
71885848|NCT04183335|143292193|SUPERIORITY||Least square mean difference|-2.17|||<|0.0001|TWO_SIDED|95.0|-3.07|-1.28||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.28|-3.07|<0.0001
71885849|NCT04183335|143292194|SUPERIORITY||Least square mean difference|-2.6||||0.0082|TWO_SIDED|95.0|-4.52|-0.67||Threshold of significance at 0.05.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.67|-4.52|0.0082
71885850|NCT04183335|143292202|SUPERIORITY||LS mean difference|-0.7||||0.0119|TWO_SIDED|95.0|-1.25|-0.15||Threshold of significance at \<0.05 level.|ANCOVA||Dupilumab 300 mg Q2W versus Placebo|||-0.15|-1.25|0.0119
71885851|NCT03193398|143292264|OTHER||Mean Difference (Net)|-1.3||||0.5939|TWO_SIDED|95.0|-6.3|3.6|||MMRM|MMRM: mixed model for repeated measures||Difference in LS Means (BTRX-246040 - Placebo)||3.6|-6.3|0.5939
71885852|NCT03193398|143292265|OTHER||Mean Difference (Net)|-1.0||||0.5503|TWO_SIDED|95.0|-4.4|2.3|||MMRM|MMRM: mixed model for repeated measures||Analysis of Change from Baseline in Investigator-administered MADRS-6 Total Score at week 8||2.3|-4.4|0.5503
71885853|NCT03193398|143292266|OTHER||Mean Difference (Net)|0.8||||0.3906|TWO_SIDED|95.0|-1.1|2.8|||MMRM|MMRM: mixed model for repeated measures||||2.8|-1.1|0.3906
71885854|NCT03193398|143292267|OTHER||Mean Difference (Net)|0.9||||0.4187|TWO_SIDED|95.0|-1.3|3.1||+/-|MMRM|MMRM: mixed model for repeated measures||||3.1|-1.3|0.4187
71885855|NCT03193398|143292268|OTHER||Mean Difference (Net)|-3.0||||0.4869|TWO_SIDED|95.0|-11.5|5.5|||MMRM|MMRM: mixed model for repeated measures||||5.5|-11.5|0.4869
71823300|NCT00495469|143149757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.452|TWO_SIDED|95.0|-0.54|0.24||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.24|-0.54|0.452
71885856|NCT03193398|143292269|OTHER||Mean Difference (Net)|1.2||||0.5178|TWO_SIDED|95.0|-2.4|4.7|||MMRM|MMRM: mixed model for repeated measures||||4.7|-2.4|0.5178
71885857|NCT03946670|143292281|SUPERIORITY|||||||0.769|||||||Cochran-Mantel-Haenszel|stratified by the randomization stratification factor IPSS-R category||||||0.769
71885858|NCT03946670|143292282|SUPERIORITY||Cox Proportional Hazard|0.749||||0.1022|TWO_SIDED|95.0|0.479|1.173|||Log Rank|stratified by the randomization stratification factor IPSS-R category||||1.173|0.479|0.1022
71885859|NCT03083886|143292349|SUPERIORITY||Risk Ratio (RR)|0.93||||0.04|TWO_SIDED|95.0|0.87|0.997|||GEE with log link and Poisson errors|||||.997|.87|.04
71885860|NCT03083886|143292349|SUPERIORITY||Risk Ratio (RR)|1.4|||<|0.001|TWO_SIDED|95.0|1.35|1.45|||GEE with log link and Poisson errors|||||1.45|1.35|<0.001
71885861|NCT03083886|143292350|SUPERIORITY||Risk Difference (RD)|-5.8|||<|0.001|TWO_SIDED|95.0|-7.7|-3.9|||GEE with identity link and normal errors|||||-3.9|-7.7|<0.001
71885862|NCT03083886|143292350|SUPERIORITY||Risk Difference (RD)|-4.3|||<|0.001|TWO_SIDED|95.0|-5.9|-2.6|||GEE with identity link and normal errors|||||-2.6|-5.9|<0.001
71885863|NCT03083886|143292351|SUPERIORITY||Risk Difference (RD)|-7.5|||<|0.001|TWO_SIDED|95.0|-9.4|-5.7|||GEE with identity link and normal errors|||||-5.7|-9.4|<0.001
71885864|NCT03083886|143292351|SUPERIORITY||Risk Difference (RD)|-6.7|||<|0.001|TWO_SIDED|95.0|-8.4|-5.0|||GEE with identity link and normal errors|||||-5.0|-8.4|<0.001
71885865|NCT03083886|143292352|SUPERIORITY||Risk Difference (RD)|4.7|||<|0.001|TWO_SIDED|95.0|2.6|6.8|||GEE with identity link and normal errors|||||6.8|2.6|<0.001
71885866|NCT03083886|143292352|SUPERIORITY||Risk Difference (RD)|6.0|||<|0.001|TWO_SIDED|95.0|4.1|7.9|||GEE with identity link and normal errors|||||7.9|4.1|<0.001
71885867|NCT03083886|143292353|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.001|TWO_SIDED|95.0|5.0|8.7|||GEE with identity link and normal errors|||||8.7|5.0|<0.001
71885868|NCT03083886|143292353|SUPERIORITY||Risk Difference (RD)|6.7|||<|0.001|TWO_SIDED|95.0|5.0|8.4|||GEE with identity link and normal errors|||||8.4|5.0|<0.001
71701110|NCT02469233|142918223|SUPERIORITY||Time by treatment interaction coeff.|-12.68||||0.59|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.59
71701111|NCT02469233|142918223|SUPERIORITY||Time by treatment interaction coeff.|-28.33||||0.22|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.22
71823301|NCT00495469|143149757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.845|TWO_SIDED|95.0|-0.44|0.36||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.36|-0.44|0.845
71823302|NCT00495469|143149757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.393|TWO_SIDED|95.0|-0.58|0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.23|-0.58|0.393
71823303|NCT00495469|143149757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.072|TWO_SIDED|95.0|-0.76|0.03||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.03|-0.76|0.072
71945393|NCT05342597|143414012|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.872|||||TWO_SIDED|90.0|0.661|1.15|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.150|0.661|
71945394|NCT05342597|143414012|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.82|||||TWO_SIDED|90.0|0.621|1.082|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.082|0.621|
71945395|NCT05342597|143414012|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of each meal condition to the fasted state.|LS Mean Ratio|0.536|||||TWO_SIDED|90.0|0.362|0.794|||ANOVA|||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.794|0.362|
71945396|NCT00968812|143414041|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.|Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.109|0.085|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||0.085|-0.109|
71945397|NCT00968812|143414041|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride|Least-Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.217|-0.023|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus glimepiride\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.||-0.023|-0.217|
71945398|NCT00968812|143414042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.06|0.16|||Regression, Logistic|||||0.16|0.06|<0.001
71945399|NCT00968812|143414042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.001|TWO_SIDED|95.0|0.05|0.14|||Regression, Logistic|||||0.14|0.05|<0.001
71945400|NCT00968812|143414043|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-5.7|-4.7|||ANCOVA|||||-4.7|-5.7|<0.001
71945401|NCT00968812|143414043|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-6.2|-5.1|||ANCOVA|||||-5.1|-6.2|<0.001
71945402|NCT00968812|143414044|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.2|0.01|||ANCOVA|||||0.010|-0.200|
71945403|NCT00968812|143414044|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.289|-0.078|||ANCOVA|||||-0.078|-0.289|
71945404|NCT01593852|143414045|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71945405|NCT01593852|143414053|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71945406|NCT02937870|143414071|OTHER||Least square (LS) mean difference|0.66||||0.177|TWO_SIDED|95.0|-0.14|1.47||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.47|-0.14|0.1770
71885869|NCT04161495|143292356|NON_INFERIORITY|Non-inferiority would be established if the upper bound of the one-sided 97.5% CI was less than 4.|Mean difference|-2.3|||||TWO_SIDED|95.0|-3.49|-1.11||||||Hierarchical testing framework: used to control type I error for secondary OM analyses. Statistical testing of Arm A intra-participant comparison non-inferiority continued only when estimation of previous OM was statistically significant at 0.05 level. For Arm A intra-participant comparison, mean difference and 95% confidence interval (CI) were estimated by NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis vs historical prophylaxis) was treated as covariate.||-1.11|-3.49|
71885870|NCT04161495|143292358|SUPERIORITY|Superiority was declared if the upper bound of the one-sided 97.5% confidence interval was less than 1.|Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.13|0.42|||Negative binomial regression mode|||Tested according to hierarchical testing procedure (only performed if the previous OM was statistically significant for the considered dosing regimen). For test about Arm A intra-participant comparison superiority, rate ratio and 95% CI were estimated using NB regression model in which treatment (BIVV001 prophylaxis vs historical prophylaxis) was treated as covariate.||0.42|0.13|<0.0001
71885871|NCT04161495|143292360|SUPERIORITY||LS mean difference|-6.74|STANDARD_ERROR_OF_MEAN|1.71||0.0001|TWO_SIDED|95.0|-10.13|-3.36|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Annualized Bleeding Rate During the Efficacy Period in Prophylaxis Arm - Superiority Analysis\] was statistically significant for considered dosing regimen). Least square (LS) mean difference, standard error and 95% confidence interval were estimated by mixed-effect model with repeated measures (MMRM) using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-3.36|-10.13|0.0001
71885872|NCT04161495|143292361|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.67||0.0042|TWO_SIDED|95.0|-3.26|-0.63|||Unstructured covariance matrix|An unstructured covariance matrix within a participant was used.||Testing according to hierarchical testing procedure. Only performed if previous OM \[Change From Baseline in Haem-A-QOL Physical Health Score at Weeks 26 and 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and PROMIS Pain Intensity 3a score as covariate.||-0.63|-3.26|0.0042
71945407|NCT02937870|143414072|OTHER||LS mean difference|-0.2||||0.8321|TWO_SIDED|95.0|-0.98|0.59||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.59|-0.98|0.8321
71701112|NCT02469233|142918223|SUPERIORITY||Time by treatment interaction coeff.|4.65||||0.8|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.80
71701113|NCT02469233|142918223|SUPERIORITY||Time by treatment interaction coeff.|-7.57||||0.68|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TST variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.68
71701114|NCT02469233|142918224|SUPERIORITY||Time by treatment interaction coeff.|-76.85||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.34
71701115|NCT02469233|142918224|SUPERIORITY||Time by treatment interaction coeff.|-87.15||||0.28|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.28
71945408|NCT02937870|143414073|OTHER||LS mean difference|0.07||||0.8566|TWO_SIDED|95.0|-0.72|0.87|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||0.87|-0.72|0.8566
71945409|NCT02937870|143414074|OTHER||LS mean difference|-0.79||||0.0488|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||-0.00|-1.58|0.0488
71701116|NCT02469233|142918224|SUPERIORITY||Time by treatment interaction coeff.|-0.15||||0.18|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.18
71701117|NCT02469233|142918224|SUPERIORITY||Time by treatment interaction coeff.|-0.27||||0.02|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Waking activity count variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.02
71701118|NCT02469233|142918225|SUPERIORITY||Time by treatment interaction coeff.|-7.19||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.09
71701119|NCT02469233|142918225|SUPERIORITY||Time by treatment interaction coeff.|-1.13||||0.79|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome.||Treatment effect on change from pre to 6-month follow-up||||0.79
71823304|NCT00495469|143149758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.767|TWO_SIDED|95.0|-0.4|0.3||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.30|-0.40|0.767
71885873|NCT04161495|143292362|SUPERIORITY||LS mean difference|-1.54|STANDARD_ERROR_OF_MEAN|0.59||0.0101|TWO_SIDED|95.0|-2.7|-0.37||An unstructured covariance matrix within a participant was used.|Unstructured covariance matrix|||Testing according to hierarchical testing procedure (only performed if previous OM \[Change From Baseline in PROMIS Pain Intensity 3a First Item at Week 52: Prophylaxis Arm\] was statistically significant for considered dosing regimen). LS mean difference, standard error and 95% confidence interval were estimated by MMRM using visit as fixed effect and Baseline Haem-A-QOL physical health score as covariate.||-0.37|-2.70|0.0101
71885874|NCT04418765|143292432|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.9|-2.5||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 1 of testing order.|Mixed Models Analysis|||Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.||-2.5|-3.9|<0.0001
71885875|NCT04418765|143292432|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.4|-2.0||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 3 of testing order.|Mixed Models Analysis|||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.0|-3.4|<0.0001
71885876|NCT04418765|143292433|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|6.58|||<|0.0001|TWO_SIDED|95.0|4.41|10.01||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 2 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||10.01|4.41|<0.0001
71885877|NCT04418765|143292433|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|4.91|||<|0.0001|TWO_SIDED|95.0|3.29|7.47||Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 4 of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||7.47|3.29|<0.0001
71885878|NCT04418765|143292434|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.5|-3.0||Threshold for significance: p-value \<α, where α = 0.05. Here it is test no. 5a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-3.0|-4.5|<0.0001
71890223|NCT01656772|143302050|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d = -0.05. The null hypothesis was to be rejected if Z \> 1.645 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0405|TWO_SIDED|||||Adjusted to take into account the correlation between multiple PVs on the same subject. The sample estimate of the intraclass correlation coefficient was calculated as the Pearson sample correlation coefficient for all pairs of observations.|Farrington and Manning|||The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject.||||0.0405
71701120|NCT02469233|142918226|SUPERIORITY||Time by treatment interaction coeff.|0.16||||0.46|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcome,||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.46
71701121|NCT02469233|142918226|SUPERIORITY||Time by treatment interaction coeff.|-0.34||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up||||0.10
71701122|NCT02469233|142918227|SUPERIORITY||Time by treatment interaction coeff.|0.91||||0.002|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.002
71701123|NCT02469233|142918227|SUPERIORITY||Time by treatment interaction coeff.|0.64||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Treatment effect on change from pre to 6-month follow-up.||||0.03
71701124|NCT02469233|142918228|SUPERIORITY||Time by treatment interaction coeff.|24.85||||0.23|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.23
71701125|NCT02469233|142918228|SUPERIORITY||Time by treatment interaction coeff.|34.31||||0.09|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Means of total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.09
71701126|NCT02469233|142918228|SUPERIORITY||Time by treatment interaction coeff.|-19.9||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.19
71701127|NCT02469233|142918228|SUPERIORITY||Time by treatment interaction coeff.|-1.76||||0.91|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Variability of Total sleep time: Treatment effect on change from pre to 6-month follow-up||||0.91
71701128|NCT02469233|142918229|SUPERIORITY||Time by treatment interaction coeff.|-39.33||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.04
71701129|NCT02469233|142918229|SUPERIORITY||Time by treatment interaction coeff.|-28.56||||0.13|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.13
71701130|NCT02469233|142918229|SUPERIORITY||Time by treatment interaction coeff.|-17.57||||0.21|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min) : Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.21
71890224|NCT01656772|143302051|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin d= 0.07. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z \< -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0441|TWO_SIDED||||||Z-statistic|||||||.0441
71701131|NCT02469233|142918229|SUPERIORITY||Time by treatment interaction coeff.|-16.05||||0.25|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.25
71701132|NCT02469233|142918230|SUPERIORITY||Time by treatment interaction coeff.|-0.55||||0.1|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||Bedtime (BT) mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.10
71701133|NCT02469233|142918230|SUPERIORITY||Time by treatment interaction coeff.|-0.71||||0.04|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT mean: Treatment effect on change from pre to 6-month follow-up.||||0.04
71701134|NCT02469233|142918230|SUPERIORITY||Time by treatment interaction coeff.|-0.31||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.20
71701135|NCT02469233|142918230|SUPERIORITY||Time by treatment interaction coeff.|-0.45||||0.07|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||BT variability: Treatment effect on change from pre to 6-month follow-up.||||0.07
71701136|NCT02469233|142918231|SUPERIORITY||Time by treatment interaction coeff.|-0.33||||0.39|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.39
71885879|NCT04418765|143292434|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.8|-2.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6a of testing order.|Mixed Models Analysis|Testing continued only, if the previous comparison was statistically significant.||"Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/\>14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error."||-2.2|-3.8|<0.0001
71885880|NCT04418765|143292435|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|11.43|||<|0.0001|TWO_SIDED|95.0|5.22|30.15||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||30.15|5.22|<0.0001
71885881|NCT04418765|143292435|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|4.16|24.35||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6b of testing order.|Regression, Logistic|||"Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/\>14) as factors.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||24.35|4.16|<0.0001
71885882|NCT04418765|143292436|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-6.7|-4.2||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 5c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-4.2|-6.7|<0.0001
71885883|NCT04418765|143292436|OTHER|Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.|Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-5.0|-2.5||Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be \<α/3, \<α/2, and \<α, where α = 0.05. Here it is test no. 6c of testing order.|Mixed Models Analysis|||"Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/\>14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.~A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.~Testing continued only, if the previous comparison was statistically significant."||-2.5|-5.0|<0.0001
71885884|NCT01789970|143292473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.26|1.0||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in WPI were compared between the active drug and placebo treatment groups.||1.00|0.26|<0.001
71945410|NCT02937870|143414075|OTHER||LS mean difference|0.86||||0.0352|TWO_SIDED|95.0|0.06|1.66|||ANCOVA|ANCOVA with factors for subject (random effect), period \& treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||1.66|0.06|0.0352
71945411|NCT00609674|143414095|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||||||0.004
71945412|NCT00571064|143414112|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.6593
71701137|NCT02469233|142918231|SUPERIORITY||Time by treatment interaction coeff.|-0.02||||0.96|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT mean: Treatment effect on change from pre to 6-month follow-up.||||0.96
71701138|NCT02469233|142918231|SUPERIORITY||Time by treatment interaction coeff.|-0.39||||0.047|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.047
71701139|NCT02469233|142918231|SUPERIORITY||Time by treatment interaction coeff.|0.2||||0.3|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||WT variability: Treatment effect on change from pre to 6-month follow-up.||||0.30
71701140|NCT02469233|142918232|SUPERIORITY||Time by treatment interaction coeff.|-4.42||||0.66|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.66
71701141|NCT02469233|142918232|SUPERIORITY||Time by treatment interaction coeff.|-13.34||||0.19|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT mean (min): Treatment effect on change from pre to 6-month follow-up.||||0.19
71701142|NCT02469233|142918232|SUPERIORITY||Time by treatment interaction coeff.|-0.05||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to post, which is 9-14 weeks after the beginning of treatment.||||0.77
71701143|NCT02469233|142918232|SUPERIORITY||Time by treatment interaction coeff.|-0.22||||0.2|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||TWT variability (min): Treatment effect on change from pre to 6-month follow-up.||||0.20
71701144|NCT01787838|142918252|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.0001|TWO_SIDED|95.0|1.65|1.96|||Chi-squared|||Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.||1.96|1.65|<.0001
71701145|NCT01431976|142918253|SUPERIORITY_OR_OTHER||percentage of participants|35.0|||||TWO_SIDED|95.0|15.39|59.22||||||||59.22|15.39|
71701146|NCT00782067|142918278|OTHER|Single arm study|||||<|0.001|TWO_SIDED|95.0||||Null hypothesis: ORR \<= 30% Alternative hypothesis: ORR \>= 50%|Exact Binomial Test||||Exact Binomial 95% Confidence Interval|||<0.001
71823305|NCT00495469|143149758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.604|TWO_SIDED|95.0|-0.46|0.27||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.27|-0.46|0.604
71885885|NCT01789970|143292474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED|95.0|0.25|0.91||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in API were compared between the active drug and placebo treatment groups.||0.91|0.25|<0.001
71885886|NCT01789970|143292475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.059|TWO_SIDED|95.0|0.5|1.01||5% significance level|Wald chi-square|Cox proportional hazards model with treatment, baseline worst pain intensity (WPI), opioid status, and center in the model||||1.01|0.5|0.059
71701147|NCT01970371|142918303|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|26.5|||||TWO_SIDED|90.0|-0.7|51.2|||1-sided Fisher's exact test|||||51.2|-0.7|
71701148|NCT01970371|142918304|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|28.2|||||TWO_SIDED|90.0|0.7|52.5|||1-sided Fisher's exact test|||||52.5|0.7|
71701149|NCT01970371|142918305|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the difference in clinical cure percentage at the TOC visit between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|-0.3|||||TWO_SIDED|90.0|-26.9|26.8|||1-sided Fisher's exact test|||||26.8|-26.9|
71701150|NCT01970371|142918306|SUPERIORITY|The 2-sided 90% confidence interval (CI) for the unadjusted hazard ratio between groups in Cohort 1 (colistin:plazomicin) is based on a Cox proportional hazards regression model.|Hazard Ratio (HR)|3.97|||||TWO_SIDED|90.0|1.08|14.61|||1-sided logrank test|||||14.61|1.08|
71701151|NCT01970371|142918307|SUPERIORITY|The two-sided 90% confidence interval for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|14.1|||||TWO_SIDED|90.0|-13.0|40.3|||1-sided Fisher's exact test|||||40.3|-13|
71701152|NCT02239328|142918313|OTHER|Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p \< 0.05.|||||<|0.05|||||||ANOVA|||||||<0.05
71701153|NCT02313155|142918397|SUPERIORITY_OR_OTHER||Difference|-6.6|||||TWO_SIDED|95.0|-24.858|11.592|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H1N1 Strain||11.592|-24.858|
71823306|NCT00495469|143149758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.483|TWO_SIDED|95.0|-0.23|0.48||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.48|-0.23|0.483
71823307|NCT00495469|143149758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.956|TWO_SIDED|95.0|-0.35|0.37||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.37|-0.35|0.956
71945413|NCT00571064|143414112|SUPERIORITY_OR_OTHER|||||||0.6048|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.6048
71885887|NCT01789970|143292476|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0293|TWO_SIDED|95.0|0.47|0.96||5% significance level|Regression, Logistic|stratified by center with the following effects: treatment group, baseline API, and opioid status.|Hydrocodone ER / Placebo|API increase \>=30% and API \>=5||0.96|0.47|0.0293
71885888|NCT01789970|143292477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.557|TWO_SIDED|95.0|-1.2|0.65||5% significance level|ANCOVA|Model with the following effects: treatment, study center, opioid status, and baseline RMDQ score.|Placebo - Hydrocodone ER|||0.65|-1.20|0.557
71885889|NCT01121393|143292485|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
71885890|NCT01121393|143292485|SUPERIORITY||Hazard Ratio (HR)|0.281|||||TWO_SIDED|95.0|0.203|0.389||||||A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.||0.389|0.203|
71885891|NCT01121393|143292486|SUPERIORITY||Odds Ratio (OR)|7.572|||<|0.0001|TWO_SIDED|95.0|4.522|12.679|||Regression, Logistic|||A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.||12.679|4.522|<0.0001
71885892|NCT01121393|143292487|SUPERIORITY||Odds Ratio (OR)|3.843|||<|0.0001|TWO_SIDED|95.0|2.039|7.24|||Regression, Logistic|||stratified for EGFR mutation group||7.240|2.039|<0.0001
71885893|NCT01121393|143292488|SUPERIORITY|||||||0.4013|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||||0.4013
71885894|NCT01121393|143292488|SUPERIORITY||Hazard Ratio (HR)|0.904|||||TWO_SIDED|95.0|0.715|1.144||||||A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.||1.144|0.715|
71885895|NCT01121393|143292492|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-17.1|-10.19|||ANCOVA|adjusted for baseline sum of diameters and EGFR mutation group||||-10.19|-17.10|<0.0001
71885896|NCT01121393|143292495|SUPERIORITY|||||||0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0001
71885897|NCT01121393|143292495|SUPERIORITY||Hazard Ratio (HR)|0.458|||||TWO_SIDED|95.0|0.303|0.692||||||Cox proportional hazard model stratified by EGFR mutation group||0.692|0.303|
71885898|NCT01121393|143292496|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||<0.0001
71885899|NCT01121393|143292496|SUPERIORITY||Hazard Ratio (HR)|0.534|||||TWO_SIDED|95.0|0.394|0.724||||||Cox proportional hazard model stratified by EGFR mutation group||0.724|0.394|
71885900|NCT01121393|143292497|SUPERIORITY|||||||0.022|TWO_SIDED||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.||||0.0220
71885901|NCT01121393|143292497|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.511|0.956||||||Cox proportional hazard model stratified by EGFR mutation group||0.956|0.511|
71885902|NCT02123485|143292503|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
71885903|NCT03423342|143292506|SUPERIORITY||Mean Difference (Net)|30.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001|TWO_SIDED|||||The updated p-value is calculated and not a threshold for statistical significance.|t-test, 2 sided|||||||<0.0001
71885904|NCT03423342|143292507|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71885905|NCT03423342|143292508|SUPERIORITY||Mean Difference (Net)|19.0|STANDARD_ERROR_OF_MEAN|48.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71885906|NCT03423342|143292509|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|17.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71885907|NCT03423342|143292510|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|3.1|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71885908|NCT03423342|143292511|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.66|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71885909|NCT02296242|143292512|OTHER||Highest dose (mg) with no DLTs.|600.0|||||TWO_SIDED|||||||||In Part 1, 2 patients experienced DLTs in the 750 mg b.i.d. treatment group (2/7; 29%). There were no dose-limiting toxicities in the 600 mg b.i.d. group or 300 mg b.i.d. group. Therefore, based on these results, 600 mg b.i.d. was selected as the MTD dose (and RP2D dose) which was used as the treatment dose in Part 2 of the study.||||
71885910|NCT01077973|143292517|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|-1.12||||0.299|TWO_SIDED|95.0|-3.23|1.0||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.00|-3.23|0.299
71885911|NCT01077973|143292518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.193|TWO_SIDED|95.0|0.52|1.14||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.14|0.52|0.193
71945414|NCT00571064|143414112|SUPERIORITY_OR_OTHER|||||||0.5924|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.5924
71885912|NCT01077973|143292519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.304|TWO_SIDED|95.0|0.5|1.24||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.24|0.50|0.304
71701154|NCT02313155|142918397|SUPERIORITY_OR_OTHER||Difference|-15.5|||||TWO_SIDED|95.0|-33.779|2.87|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H3N2 Strain||2.870|-33.779|
71701155|NCT02313155|142918397|SUPERIORITY_OR_OTHER||Difference|-11.8|||||TWO_SIDED|95.0|-30.048|6.547|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|B Strain||6.547|-30.048|
71701156|NCT00689936|142918416|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||6e-05|TWO_SIDED|95.0|0.61|0.85||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.85|0.61|0.00006
71701157|NCT00689936|142918416|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||1e-05|TWO_SIDED|95.0|0.6|0.82||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||0.82|0.60|0.00001
71701158|NCT00689936|142918416|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.70349|TWO_SIDED|95.0|0.89|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.20|0.89|0.70349
71701159|NCT00689936|142918417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|1e-05|TWO_SIDED|95.0|0.59|0.79||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.79|0.59|<0.00001
71701160|NCT00689936|142918417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|1e-05|TWO_SIDED|95.0|0.6|0.81||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.81|0.60|<0.00001
71701161|NCT00689936|142918417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.91161|TWO_SIDED|95.0|0.86|1.14||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.14|0.86|0.91161
71945415|NCT00571064|143414113|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||<0.0001
71701162|NCT00689936|142918418|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.00234|TWO_SIDED|95.0|0.67|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.67|0.00234
71701163|NCT00689936|142918418|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.82903|TWO_SIDED|95.0|0.86|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.20|0.86|0.82903
71701164|NCT00689936|142918418|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00119|TWO_SIDED|95.0|0.66|0.9||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.90|0.66|0.00119
71701165|NCT00689936|142918419|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||<|1e-05|TWO_SIDED|95.0|1.41|2.37|||Fisher Exact|||||2.37|1.41|<0.00001
71701166|NCT00689936|142918419|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.53065|TWO_SIDED|95.0|0.83|1.44|||Fisher Exact|||||1.44|0.83|0.53065
71823308|NCT00495469|143149758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.185|TWO_SIDED|95.0|-0.12|0.6||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.60|-0.12|0.185
71945416|NCT00571064|143414113|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||<0.0001
71945417|NCT00571064|143414113|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||<0.0001
71945418|NCT00571064|143414115|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.0431
71701167|NCT00689936|142918419|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.0001|TWO_SIDED|95.0|1.29|2.15|||Fisher Exact|||||2.15|1.29|0.00010
71701168|NCT00689936|142918420|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||<|1e-05|TWO_SIDED|95.0|1.53|2.68|||Fisher Exact|||||2.68|1.53|<0.00001
71701169|NCT00689936|142918420|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.405|TWO_SIDED|95.0|0.85|1.54|||Fisher Exact|||||1.54|0.85|0.40500
71701170|NCT00689936|142918420|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||4e-05|TWO_SIDED|95.0|1.35|2.32|||Fisher Exact|||||2.32|1.35|0.00004
71701171|NCT00689936|142918421|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.51|0.76||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.76|0.51|<0.00001
71701172|NCT00689936|142918421|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|1e-05|TWO_SIDED|95.0|0.5|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.72|0.50|<0.00001
71701173|NCT00689936|142918421|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.7674|TWO_SIDED|95.0|0.86|1.23||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.23|0.86|0.76740
71701174|NCT00689936|142918422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.51|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.51|<0.00001
71701175|NCT00689936|142918422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.52|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.72|0.52|<0.00001
71885913|NCT01077973|143292519|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.936|TWO_SIDED|95.0|0.65|1.59||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.59|0.65|0.936
71945419|NCT00571064|143414115|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.0431
71945420|NCT00571064|143414117|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.1285
71885914|NCT01077973|143292520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.072|TWO_SIDED|95.0|0.41|1.04||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.04|0.41|0.072
71823309|NCT00495469|143149758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.863|TWO_SIDED|95.0|-0.32|0.39||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.39|-0.32|0.863
71885915|NCT01077973|143292520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.652|TWO_SIDED|95.0|0.58|1.41||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.41|0.58|0.652
71885916|NCT01077973|143292520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.108|TWO_SIDED|95.0|0.49|1.07||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.07|0.49|0.108
71885917|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.402|TWO_SIDED|95.0|-0.65|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.65|0.402
71885918|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.407|TWO_SIDED|95.0|-0.64|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.64|0.407
71885919|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.38|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.38|0.991
71885920|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.313|TWO_SIDED|95.0|-0.75|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.75|0.313
71885921|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.621|TWO_SIDED|95.0|-0.62|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.62|0.621
71885922|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.533|TWO_SIDED|95.0|-0.54|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.54|0.533
71945421|NCT00571064|143414117|SUPERIORITY_OR_OTHER|||||||0.1285|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)||||0.1285
71945422|NCT00571064|143414119|SUPERIORITY_OR_OTHER|||||||0.2327|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)||||0.2327
71945423|NCT00571064|143414119|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)||||0.4724
71823310|NCT00495469|143149759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.348|TWO_SIDED|95.0|-0.46|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|-0.46|0.348
71823311|NCT00495469|143149759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.952|TWO_SIDED|95.0|-0.33|0.31||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.31|-0.33|0.952
71823312|NCT00495469|143149759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.523|TWO_SIDED|95.0|-0.21|0.42||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.42|-0.21|0.523
71885923|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.352|TWO_SIDED|95.0|-0.79|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.28|-0.79|0.352
71885924|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.573|TWO_SIDED|95.0|-0.69|0.38||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.69|0.573
71885925|NCT01077973|143292521|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.657|TWO_SIDED|95.0|-0.54|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-0.54|0.657
71885926|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.382|TWO_SIDED|95.0|-0.36|0.14||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.36|0.382
71885927|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.242|TWO_SIDED|95.0|-0.39|0.1||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.10|-0.39|0.242
71885928|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|0.04||||0.72|TWO_SIDED|95.0|-0.17|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.24|-0.17|0.720
71885929|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.235|TWO_SIDED|95.0|-0.43|0.11||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.11|-0.43|0.235
71885930|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.63|TWO_SIDED|95.0|-0.34|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.34|0.630
71885931|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.393|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.393
71885932|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.382|TWO_SIDED|95.0|-0.46|0.18||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.46|0.382
71885933|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.995|TWO_SIDED|95.0|-0.32|0.32||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.32|-0.32|0.995
71885934|NCT01077973|143292522|SUPERIORITY_OR_OTHER||LS mean difference|-0.14||||0.287|TWO_SIDED|95.0|-0.41|0.12||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.12|-0.41|0.287
71885935|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.377|TWO_SIDED|95.0|-0.98|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.37|-0.98|0.377
71885936|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.324|TWO_SIDED|95.0|-1.01|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.01|0.324
71885937|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.902|TWO_SIDED|95.0|-0.52|0.59||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.52|0.902
71885938|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.273|TWO_SIDED|95.0|-1.17|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-1.17|0.273
71885939|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.616|TWO_SIDED|95.0|-0.94|0.56||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.94|0.616
71885940|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.471|TWO_SIDED|95.0|-0.85|0.39||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.39|-0.85|0.471
71885941|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.356|TWO_SIDED|95.0|-1.24|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.24|0.356
71945424|NCT00571064|143414119|SUPERIORITY_OR_OTHER|||||||0.4724|TWO_SIDED|||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF - Study Endpoint||||0.4724
71945425|NCT00244764|143414120|SUPERIORITY_OR_OTHER||percentage|34.7||||||95.0|28.4|40.9|||||The estimated value provided is the response rate.|||40.9|28.4|
71701176|NCT00689936|142918422|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99537|TWO_SIDED|95.0|0.85|1.17||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.17|0.85|0.99537
71701177|NCT00689936|142918423|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71701178|NCT00689936|142918423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46672|||||||Wilcoxon (Mann-Whitney)|||||||0.46672
71701179|NCT00689936|142918423|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71701180|NCT00689936|142918424|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71701181|NCT00689936|142918424|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46987|||||||Wilcoxon (Mann-Whitney)|||||||0.46987
71701182|NCT00689936|142918424|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71701183|NCT00689936|142918425|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.00012|TWO_SIDED|95.0|0.68|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.68|0.00012
71701184|NCT00689936|142918425|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00187|TWO_SIDED|95.0|0.71|0.93||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.93|0.71|0.00187
71701185|NCT00689936|142918425|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.45973|TWO_SIDED|95.0|0.84|1.08||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.08|0.84|0.45973
71701186|NCT00689936|142918426|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||2e-05|TWO_SIDED|95.0|0.67|0.86||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.86|0.67|0.00002
71701187|NCT00689936|142918426|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.00126|TWO_SIDED|95.0|0.72|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.92|0.72|0.00126
71701188|NCT00689936|142918426|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.27704|TWO_SIDED|95.0|0.83|1.06||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.06|0.83|0.27704
71701189|NCT00689936|142918427|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|1e-05|TWO_SIDED|95.0|0.56|0.78||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.78|0.56|<0.00001
71823313|NCT00495469|143149759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.889|TWO_SIDED|95.0|-0.34|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.34|0.889
71885942|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.722|TWO_SIDED|95.0|-1.0|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-1.00|0.722
71701190|NCT00689936|142918427|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.00067|TWO_SIDED|95.0|0.63|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||0.88|0.63|0.00067
71701191|NCT00689936|142918427|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.12333|TWO_SIDED|95.0|0.75|1.03||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model|||1.03|0.75|0.12333
71701192|NCT00689936|142918428|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|1e-05|TWO_SIDED|95.0|0.54|0.73||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||.73|0.54|<0.00001
71701193|NCT00689936|142918428|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||1e-05|TWO_SIDED|95.0|0.61|0.83||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||0.83|0.61|0.00001
71823314|NCT00495469|143149759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.124|TWO_SIDED|95.0|-0.07|0.56||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.56|-0.07|0.124
71701194|NCT00689936|142918428|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.05821|TWO_SIDED|95.0|0.76|1.0||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.|||1.00|0.76|0.05821
71701195|NCT00689936|142918429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.93824|TWO_SIDED|95.0|0.75|1.38|||Fisher Exact|||||1.38|0.75|0.93824
71701196|NCT00689936|142918429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.08836|TWO_SIDED|95.0|0.56|1.03|||Fisher Exact|||||1.03|0.56|0.08836
71701197|NCT00689936|142918429|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.04974|TWO_SIDED|95.0|1.01|1.79|||Fisher Exact|||||1.79|1.01|0.04974
71701198|NCT00689936|142918430|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.02134|TWO_SIDED|95.0|1.08|2.59|||Fisher Exact|||||2.59|1.08|0.02134
71701199|NCT00689936|142918430|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.64|1.59|||Fisher Exact|||||1.59|0.64|1.00000
71701200|NCT00689936|142918430|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.02374|TWO_SIDED|95.0|1.08|2.53|||Fisher Exact|||||2.53|1.08|0.02374
71701201|NCT00689936|142918431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.11152|TWO_SIDED|95.0|0.91|3.21|||Fisher Exact|||||3.21|0.91|0.11152
71701202|NCT00689936|142918431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.86336|TWO_SIDED|95.0|0.47|1.83|||Fisher Exact|||||1.83|0.47|0.86336
71701203|NCT00689936|142918431|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07321|TWO_SIDED|95.0|0.96|3.55|||Fisher Exact|||||3.55|0.96|0.07321
71701204|NCT00689936|142918432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.62||||0.00043|TWO_SIDED|95.0|1.55|4.45|||Fisher Exact|||||4.45|1.55|0.00043
71701205|NCT00689936|142918432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.31274|TWO_SIDED|95.0|0.78|2.43|||Fisher Exact|||||2.43|0.78|0.31274
71701206|NCT00689936|142918432|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.01936|TWO_SIDED|95.0|1.13|3.19|||Fisher Exact|||||3.19|1.13|0.01936
71823315|NCT00495469|143149759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.581|TWO_SIDED|95.0|-0.22|0.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.40|-0.22|0.581
71701207|NCT00689936|142918433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.82128|TWO_SIDED|95.0|0.46|2.8|||Fisher Exact|||||2.80|0.46|0.82128
71701208|NCT00689936|142918433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.11041|TWO_SIDED|95.0|0.19|1.14|||Fisher Exact|||||1.14|0.19|0.11041
71701209|NCT00689936|142918433|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.44||||0.07302|TWO_SIDED|95.0|1.01|5.91|||Fisher Exact|||||5.91|1.01|0.07302
71701210|NCT01532089|142918461|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.39|TWO_SIDED|95.0|0.5|1.31|||Log Rank|Comparisons of PFS between arms were conducted using a stratified log-rank test.||||1.31|0.50|0.39
71701211|NCT01532089|142918462|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.33|TWO_SIDED|95.0|0.71|2.81|||Log Rank|||||2.81|0.71|0.33
71701212|NCT01532089|142918463|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
71701213|NCT01995201|142918476|OTHER|||||||0.5231|||||||Chi-squared|||||||0.5231
71701214|NCT00622518|142918519|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||P value is based on rating\*group interaction term|linear mixed model|||||||.002
71701215|NCT06001866|142918624|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
71885943|NCT01077973|143292523|SUPERIORITY_OR_OTHER||LS mean difference|-0.24||||0.493|TWO_SIDED|95.0|-0.94|0.46||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|-0.94|0.493
71701216|NCT06001866|142918624|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71701217|NCT06001866|142918625|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71701218|NCT06001866|142918625|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71701219|NCT06001866|142918626|SUPERIORITY||||||=|0.78|||||||LSD test|||||||=0.78
71701220|NCT06001866|142918626|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<.00001
71701221|NCT06001866|142918627|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
71701222|NCT06001866|142918627|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71701223|NCT06001866|142918628|SUPERIORITY||||||=|0.75|||||||LSD test|||||||=0.75
71701224|NCT06001866|142918628|SUPERIORITY||||||<|0.01|||||||LSD test|||||||<0.01
71701225|NCT06001866|142918629|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71701226|NCT06001866|142918629|SUPERIORITY||||||=|0.62|||||||LSD test|||||||=0.62
71701227|NCT06001866|142918630|SUPERIORITY||||||=|0.16|||||||LSD test|||||||=0.16
71701228|NCT06001866|142918630|SUPERIORITY||||||=|0.33|||||||LSD test|||||||=0.33
71701229|NCT06001866|142918631|SUPERIORITY||||||=|0.54|||||||t-test, 2 sided|||||||=.54
71701230|NCT06001866|142918632|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71701231|NCT02903914|142918640|OTHER|||||||0.0731|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0731
71701232|NCT02903914|142918640|OTHER||pairwise geometric mean ratio (GMR)|0.933|||||TWO_SIDED|90.0|0.784|1.11||||||||1.110|0.784|
71701233|NCT02903914|142918640|OTHER||pairwise GMR|1.074|||||TWO_SIDED|90.0|0.908|1.271||||||||1.271|0.908|
71701234|NCT02903914|142918640|OTHER||pairwise GMR|1.23|||||TWO_SIDED|90.0|1.034|1.463||||||||1.463|1.034|
71701235|NCT02903914|142918641|OTHER|||||||0.1496|||||||Kruskal-Wallis|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1496
71701236|NCT02903914|142918642|OTHER|||||||0.2867|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2867
71701237|NCT02903914|142918642|OTHER||pairwise GMR|1.007|||||TWO_SIDED|90.0|0.825|1.23||||||||1.230|0.825|
71701238|NCT02903914|142918642|OTHER||pairwise GMR|1.081|||||TWO_SIDED|90.0|0.892|1.311||||||||1.311|0.892|
71701239|NCT02903914|142918642|OTHER||pairwise GMR|1.234|||||TWO_SIDED|90.0|1.011|1.507||||||||1.507|1.011|
71701240|NCT02903914|142918643|OTHER|||||||0.6167|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6167
71701241|NCT02903914|142918643|OTHER||pairwise GMR|1.014|||||TWO_SIDED|90.0|0.82|1.255||||||||1.255|0.820|
71701242|NCT02903914|142918643|OTHER||pairwise GMR|1.043|||||TWO_SIDED|90.0|0.849|1.281||||||||1.281|0.849|
71701243|NCT02903914|142918643|OTHER||pairwise GMR|1.17|||||TWO_SIDED|90.0|0.945|1.447||||||||1.447|0.945|
71701244|NCT02903914|142918647|OTHER|||||||0.0745|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.0745
71701245|NCT02903914|142918647|OTHER||pairwise GMR|1.127|||||TWO_SIDED|90.0|0.947|1.341||||||||1.341|0.947|
71701246|NCT02903914|142918647|OTHER||pairwise GMR|0.991|||||TWO_SIDED|90.0|0.833|1.18||||||||1.180|0.833|
71701247|NCT02903914|142918647|OTHER||pairwise GMR|1.258|||||TWO_SIDED|90.0|1.064|1.486||||||||1.486|1.064|
71701248|NCT02903914|142918648|OTHER|||||||0.0518|||||||Kruskal-Wallis|||||||0.0518
71701249|NCT02903914|142918649|OTHER|||||||0.1723|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1723
71701250|NCT02903914|142918649|OTHER||pairwise GMR|1.156|||||TWO_SIDED|90.0|0.941|1.42||||||||1.420|0.941|
71701251|NCT02903914|142918649|OTHER||pairwise GMR|0.976|||||TWO_SIDED|90.0|0.794|1.198||||||||1.198|0.794|
71701252|NCT02903914|142918649|OTHER||pairwise GMR|1.233|||||TWO_SIDED|90.0|1.012|1.503||||||||1.503|1.012|
71701253|NCT02903914|142918650|OTHER|||||||0.1705|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1705
71701254|NCT02903914|142918650|OTHER||pairwise GMR|1.083|||||TWO_SIDED|90.0|0.863|1.359||||||||1.359|0.863|
71701255|NCT02903914|142918650|OTHER||pairwise GMR|0.902|||||TWO_SIDED|90.0|0.719|1.132||||||||1.132|0.719|
71701256|NCT02903914|142918650|OTHER||pairwise GMR|1.212|||||TWO_SIDED|90.0|0.945|1.554||||||||1.554|0.945|
71701257|NCT02903914|142918654|OTHER||pairwise GMR|1.057||||0.7702|TWO_SIDED|90.0|0.753|1.483|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.483|0.753|0.7702
71885944|NCT01077973|143292524|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.259|TWO_SIDED|95.0|-0.75|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.20|-0.75|0.259
71945426|NCT00244764|143414121|SUPERIORITY_OR_OTHER||percentage|42.0||||||95.0|29.0|54.0|||||The estimated value is the percentage of the first 60 participants who had stable disease at Week 12, as assessed by the investigator.|||54|29|
71945427|NCT03872128|143414158|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71701258|NCT02903914|142918654|OTHER||pairwise GMR|1.012||||0.9384|TWO_SIDED|90.0|0.762|1.346|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.346|0.762|0.9384
71701259|NCT02903914|142918654|OTHER||pairwise GMR|1.07||||0.6733|TWO_SIDED|90.0|0.809|1.415|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.415|0.809|0.6733
71701260|NCT02903914|142918654|OTHER||pairwise GMR|1.238||||0.3456|TWO_SIDED|90.0|0.83|1.847|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.847|0.830|0.3456
71701261|NCT02903914|142918655|OTHER|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.0441
71701262|NCT02903914|142918655|OTHER|||||||0.4092|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.4092
71701263|NCT02903914|142918655|OTHER|||||||0.7748|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.7748
71701264|NCT02903914|142918655|OTHER|||||||0.1948|||||||Wilcoxon (Mann-Whitney)|||Fed versus Fasted||||0.1948
71701265|NCT02903914|142918656|OTHER||pairwise GMR|0.92||||0.705|TWO_SIDED|90.0|0.62|1.363|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.363|0.620|0.7050
71701266|NCT02903914|142918656|OTHER||pairwise GMR|0.929||||0.703|TWO_SIDED|90.0|0.658|1.31|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.310|0.658|0.7030
71701267|NCT02903914|142918656|OTHER||pairwise GMR|0.999||||0.9952|TWO_SIDED|90.0|0.725|1.377|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.377|0.725|0.9952
71823316|NCT00495469|143149760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.518|TWO_SIDED|95.0|-0.05|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.10|-0.05|0.518
71823317|NCT00495469|143149760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.352|TWO_SIDED|95.0|-0.04|0.11||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.11|-0.04|0.352
71885945|NCT01077973|143292524|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.378|TWO_SIDED|95.0|-0.69|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.26|-0.69|0.378
71945428|NCT03872128|143414159|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
71701268|NCT02903914|142918656|OTHER||pairwise GMR|0.742||||0.4012|TWO_SIDED|90.0|0.394|1.397|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = food effect)||Fed versus Fasted||1.397|0.394|0.4012
71701269|NCT02903914|142918657|OTHER||pairwise GMR|0.992||||0.9623|TWO_SIDED|90.0|0.729|1.349|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.349|0.729|0.9623
71701270|NCT02903914|142918658|OTHER|||||||0.754|||||||Wilcoxon (Mann-Whitney)|||Tablet (test) versus Capsule (reference)||||0.7540
71701271|NCT02903914|142918659|OTHER||pairwise GMR|0.951||||0.7514|TWO_SIDED|90.0|0.718|1.261|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||Tablet (test) versus Capsule (reference)||1.261|0.718|0.7514
71701272|NCT02903914|142918660|OTHER||pairwise GMR|0.954||||0.7707|TWO_SIDED|90.0|0.712|1.277|||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = formulation)||Tablet (test) versus Capsule (reference)||1.277|0.712|0.7707
71701273|NCT04725188|142918666|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.091|TWO_SIDED|95.0|0.53|1.13|||Regression, Cox|||||1.13|0.53|0.0910
71701274|NCT04725188|142918666|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.9622|TWO_SIDED|95.0|0.96|2.02|||Regression, Cox|||||2.02|0.96|0.9622
71701275|NCT04725188|142918667|SUPERIORITY||Difference in percentage|14.7||||0.0113|TWO_SIDED|95.0|2.1|26.9|||Miettinen & Nurminen method|||||26.9|2.1|0.0113
71701276|NCT04725188|142918667|SUPERIORITY||Difference in percentage|-9.4||||0.975|TWO_SIDED|95.0|-19.6|0.0|||Miettinen & Nurminen method|||||0.0|-19.6|0.9750
71701277|NCT04725188|142918668|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0943|TWO_SIDED|95.0|0.5|1.15|||Regression, Cox|||||1.15|0.50|0.0943
71701278|NCT04725188|142918668|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5974|TWO_SIDED|95.0|0.7|1.58|||Regression, Cox|||||1.58|0.70|0.5974
71701279|NCT00695019|142918751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Chi-squared|||||||0.61
71701280|NCT00695019|142918752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||Chi-squared|||||||0.48
71701281|NCT00695019|142918753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||Kruskal-Wallis|||||||0.77
71701282|NCT00695019|142918754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Kruskal-Wallis|||||||0.30
71701283|NCT00695019|142918755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||95.0|||||Chi-squared|||||||0.72
71701284|NCT00695019|142918756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023||95.0||||Analysis not adjusted to account for baseline differences between the groups.|Kruskal-Wallis|||||||0.0023
71701285|NCT00695019|142918757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||95.0|||||Kruskal-Wallis|||Fibrotest provides an estimate of liver fibrosis based on the values of 5 serum markers. Scores range from 0 to 1 with higher scores indicating a greater level of liver fibrosis. A negative change in Fibrotest score is therefore deemed to indicate improvement (reduction in fibrosis), while a positive change indicates worsening condition.||||0.21
71701286|NCT00695019|142918758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Chi-squared|||||||0.03
71701287|NCT00695019|142918758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Chi-squared|||||||0.005
71701288|NCT03116230|142918770|OTHER|||||||0.005|||||||t-test, 2 sided|Treatment A vs Control||||||0.005
71701289|NCT03116230|142918770|OTHER|||||||0.64|||||||t-test, 2 sided|Treatment B vs Control||||||0.64
71701290|NCT02296125|142918799|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.37|0.57|||Log Rank|||||0.57|0.37|<0.0001
71823318|NCT00495469|143149760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.16|0.01|0.026
71885946|NCT01077973|143292524|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.762|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.45|0.762
71885947|NCT01077973|143292524|SUPERIORITY_OR_OTHER||LS mean difference|-0.42||||0.281|TWO_SIDED|95.0|-1.17|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|-1.17|0.281
71885948|NCT01077973|143292524|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.582|TWO_SIDED|95.0|-0.97|0.55||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|-0.97|0.582
71885949|NCT01077973|143292524|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.523|TWO_SIDED|95.0|-0.83|0.42||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|-0.83|0.523
71885950|NCT01077973|143292525|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.327|TWO_SIDED|95.0|-1.35|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|-1.35|0.327
71885951|NCT01077973|143292525|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.489|TWO_SIDED|95.0|-1.21|0.58||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|-1.21|0.489
71885952|NCT01077973|143292525|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.726|TWO_SIDED|95.0|-0.88|0.61||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.61|-0.88|0.726
71885953|NCT01077973|143292525|SUPERIORITY_OR_OTHER||LS mean difference|-0.7||||0.32|TWO_SIDED|95.0|-2.09|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|-2.09|0.320
71885954|NCT01077973|143292525|SUPERIORITY_OR_OTHER||LS mean difference|-0.47||||0.506|TWO_SIDED|95.0|-1.86|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.86|0.506
71885955|NCT01077973|143292525|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.691|TWO_SIDED|95.0|-1.38|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.38|0.691
71885956|NCT01077973|143292526|SUPERIORITY_OR_OTHER||LS mean difference|-0.72||||0.292|TWO_SIDED|95.0|-2.07|0.62||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|-2.07|0.292
71885957|NCT01077973|143292526|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.439|TWO_SIDED|95.0|-1.87|0.82||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-1.87|0.439
71885958|NCT01077973|143292526|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.733|TWO_SIDED|95.0|-1.31|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.92|-1.31|0.733
71885959|NCT01077973|143292526|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.526|TWO_SIDED|95.0|-2.8|1.43||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.43|-2.80|0.526
71885960|NCT01077973|143292526|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.624|TWO_SIDED|95.0|-2.19|1.31||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|-2.19|0.624
71945429|NCT03872128|143414160|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
71945430|NCT03872128|143414161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Total||||<0.001
71945431|NCT03872128|143414161|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||OCDS: Obsessive||||<0.001
71945432|NCT03872128|143414161|SUPERIORITY|||||||0.003|||||||Fisher Exact|||OCDS: Compulsive||||0.003
71945433|NCT03872128|143414163|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
71945434|NCT03872128|143414164|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||HADS-Depression||||<0.001
71945435|NCT03872128|143414164|SUPERIORITY|||||||0.089|||||||Fisher Exact|||HADS-Anxiety||||0.089
71885961|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|3.02||||0.672|TWO_SIDED|95.0|-11.03|17.07||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||17.07|-11.03|0.672
71885962|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-4.47||||0.467|TWO_SIDED|95.0|-17.61|8.68||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.68|-17.61|0.467
71885963|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|7.55||||0.164|TWO_SIDED|95.0|-2.96|18.05||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.05|-2.96|0.164
71885964|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-7.52||||0.427|TWO_SIDED|95.0|-25.96|10.92||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.92|-25.96|0.427
71885965|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-5.66||||0.537|TWO_SIDED|95.0|-23.57|12.25||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.25|-23.57|0.537
71885966|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-1.83||||0.813|TWO_SIDED|95.0|-16.88|13.22||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.22|-16.88|0.813
71885967|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.455|TWO_SIDED|95.0|-19.24|8.24||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.24|-19.24|0.455
71885968|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-4.02||||0.57|TWO_SIDED|95.0|-17.63|9.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.59|-17.63|0.570
71885969|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.792|TWO_SIDED|95.0|-13.8|10.5||p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-13.80|0.792
71885970|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
71885971|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
71885972|NCT01077973|143292527|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
71885973|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|6.06||||0.48|TWO_SIDED|95.0|-10.86|22.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.99|-10.86|0.480
71885974|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|4.34||||0.612|TWO_SIDED|95.0|-12.55|21.23||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.23|-12.55|0.612
71945436|NCT02648438|143414178|SUPERIORITY_OR_OTHER||Geometric mean ratio|62.61|||||TWO_SIDED|90.0|53.01|73.94|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||73.94|53.01|
71885975|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|1.47||||0.839|TWO_SIDED|95.0|-12.6|15.55||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.55|-12.60|0.839
71885976|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-13.2||||0.13|TWO_SIDED|95.0|-29.4|2.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.99|-29.40|0.130
71885977|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-7.83||||0.331|TWO_SIDED|95.0|-23.39|7.73||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.73|-23.39|0.331
71885978|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-5.5||||0.45|TWO_SIDED|95.0|-19.59|8.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.59|-19.59|0.450
71885979|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
71885980|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
71885981|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
71885982|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-4.25||||0.556|TWO_SIDED|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.33|-17.82|0.556
71885983|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-2.77||||0.689|TWO_SIDED|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.69|-16.24|0.689
71885984|NCT01077973|143292528|SUPERIORITY_OR_OTHER||Difference in proportion|-1.65||||0.786|TWO_SIDED|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.14|-13.45|0.786
71945437|NCT02648438|143414179|SUPERIORITY_OR_OTHER||Geometric mean ratio|101.15|||||TWO_SIDED|90.0|85.21|120.06|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.||120.06|85.21|
71945438|NCT04608188|143414233|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71823319|NCT00495469|143149760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.069|TWO_SIDED|95.0|-0.01|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.01|0.069
71823320|NCT00495469|143149760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.154|TWO_SIDED|95.0|-0.02|0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.13|-0.02|0.154
71885985|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|3.89||||0.355|TWO_SIDED|95.0|-3.33|11.1||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.10|-3.33|0.355
71885986|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.623|TWO_SIDED|95.0|-6.62|4.2||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.20|-6.62|0.623
71885987|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.11||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.11|-0.90|0.094
71945439|NCT04608188|143414234|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71885988|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|4.43||||0.565|TWO_SIDED|95.0|-10.43|19.29||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.29|-10.43|0.565
71885989|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|-2.09||||0.765|TWO_SIDED|95.0|-16.15|11.97||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.97|-16.15|0.765
71885990|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|6.47||||0.288|TWO_SIDED|95.0|-5.43|18.37||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.37|-5.43|0.288
71885991|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|-0.87||||0.928|TWO_SIDED|95.0|-20.0|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-20.00|0.928
71885992|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|-6.4||||0.495|TWO_SIDED|95.0|-25.14|12.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.33|-25.14|0.495
71885993|NCT01077973|143292531|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.477|TWO_SIDED|95.0|-9.66|20.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.59|-9.66|0.477
71885994|NCT00725075|143292577|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-2.26||||0.267|TWO_SIDED|95.0|-6.25|1.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||1.74|-6.25|0.267
71885995|NCT00725075|143292577|SUPERIORITY_OR_OTHER||Mean Change From Baseline|-0.08||||0.966|TWO_SIDED|95.0|-3.91|3.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.||3.74|-3.91|0.966
71885996|NCT02340663|143292605|OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
71701291|NCT02296125|142918799|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.56||||0.0065|TWO_SIDED|95.0|0.37|0.85|||Log Rank|||||0.85|0.37|0.0065
71701292|NCT02296125|142918801|SUPERIORITY||Odds Ratio (OR)|1.51||||0.036|TWO_SIDED|95.0|1.03|2.22|||Regression, Logistic|||||2.22|1.03|0.036
71701293|NCT02296125|142918801|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.31||||0.485|TWO_SIDED|95.0|0.61|2.84|||Regression, Logistic|||||2.84|0.61|0.485
71701294|NCT02296125|142918802|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|2.48||||0.0133|TWO_SIDED|95.0|1.21|5.09|||Regression, Linear|||||5.09|1.21|0.0133
71823321|NCT00495469|143149760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.005|TWO_SIDED|95.0|0.03|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|0.03|0.005
71701295|NCT02296125|142918802|SUPERIORITY||Mean Difference (Final Values)|2.27|||<|0.0001|TWO_SIDED|95.0|1.68|3.08|||Regression, Linear|||||3.08|1.68|<0.0001
71823322|NCT00495469|143149761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.143|TWO_SIDED|95.0|-0.58|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.58|0.143
71885997|NCT02340663|143292606|OTHER|||||||0.045|||||||ANOVA|||||||0.045
71885998|NCT02340663|143292607|OTHER|||||||0.665|||||||t-test, 2 sided|||||||0.665
71885999|NCT02340663|143292608|OTHER|||||||0.249|||||||Wilcoxon (Mann-Whitney)|||||||0.249
71886000|NCT02340663|143292609|OTHER|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||||||0.626
71886001|NCT02340663|143292610|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
71886002|NCT02340663|143292611|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||0.255
71886003|NCT02340663|143292612|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||.049
71886004|NCT02340663|143292615|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
71886005|NCT02340663|143292616|OTHER||||||<|0.01||||||The P-value given is the computed value|Mixed Models Analysis|||||||<0.01
71886006|NCT02340663|143292617|OTHER|||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
71886007|NCT02340663|143292618|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.220
71886008|NCT02340663|143292619|OTHER|||||||0.081|||||||Wilcoxon (Mann-Whitney)|||||||0.081
71886009|NCT02340663|143292620|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71886010|NCT02340663|143292621|OTHER|||||||0.731|||||||Wilcoxon (Mann-Whitney)|||||||0.731
71886011|NCT02340663|143292622|OTHER|||||||0.238|||||||Wilcoxon (Mann-Whitney)|||||||0.238
71886012|NCT02340663|143292623|OTHER|||||||0.952||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.952
71886013|NCT02340663|143292624|OTHER|||||||0.53||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA|||||||0.53
71886014|NCT02340663|143292625|OTHER|||||||0.292||||||"The P-value refers to the difference in group means, see Group Means row in the table."|Mixed Models Analysis|||||||0.292
71886015|NCT02340663|143292626|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.||||0.289
71945440|NCT04608188|143414235|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71886016|NCT02340663|143292627|OTHER|||||||0.287||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.287
71886017|NCT02340663|143292628|OTHER|||||||0.505||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.505
71886018|NCT02340663|143292629|OTHER|||||||0.643||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.643
71886019|NCT02340663|143292630|OTHER|||||||0.923||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)|||||||0.923
71886020|NCT02979431|143292631|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
71886021|NCT02979431|143292631|SUPERIORITY||||||=|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||=0.001
71886022|NCT02979431|143292631|SUPERIORITY||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.||||<0.001
71886023|NCT02979431|143292632|SUPERIORITY||Mean Difference (Net)|-0.6452|STANDARD_ERROR_OF_MEAN|0.5843|=|0.271|TWO_SIDED||||||Mixed Models Analysis|||A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.||||=0.271
71886024|NCT02979431|143292632|SUPERIORITY||Difference in LS means|-0.4904|STANDARD_ERROR_OF_MEAN|0.5862|=|0.404|TWO_SIDED||||||Mixed Models Analysis|||||||=0.404
71886025|NCT02979431|143292632|SUPERIORITY||Difference in LS means|-0.2156|STANDARD_ERROR_OF_MEAN|0.5842|=|0.713|TWO_SIDED||||||Mixed Models Analysis|||||||=0.713
71886026|NCT02004873|143292648|SUPERIORITY_OR_OTHER||Kaplan-Meier survival probability (%)|96.0|||<|0.0001|TWO_SIDED|98.66|93.3|97.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|z-test, 1-sided||"The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.~The coverage level for the confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis."|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%.~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||97.6|93.3|<0.0001
71886027|NCT02004873|143292649|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|98.3|||<|0.0001|TWO_SIDED|98.66|95.4|99.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is greater than 80%."||99.6|95.4|<0.0001
71886028|NCT02004873|143292650|SUPERIORITY_OR_OTHER||Percentage of subjects (%)|99.6|||<|0.0001|TWO_SIDED|98.66|97.5|100.0||Holm adjustment for multiple comparisons for secondary objectives was used. The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is less than or equal to 85%.~Alternative hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is greater than 85%."||100.0|97.5|<0.0001
71886029|NCT02004873|143292651|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is 0.35. The Micra sensor indicated rate is considered proportional to the workload if the 90% CI for the Kay-Wilkoff slope parameter falls into \[0.65, 1.35\].|Slope|0.864|||<|0.001|TWO_SIDED|90.0|0.768|0.961||Holm adjustment for multiple comparisons for secondary objectives was used. Two One-sided Test (TOST) procedure was used at the 0.05 significance level.|t-test, 1 sided|Two One-sided Test (TOST)|A random effect linear regression model was used to assess if the Micra sensor-indicated rate was proportional to the workload using the Kay-Wilkoff model. The Kay-Wilkoff slope parameter was estimated along with its 90% CI.|Null hypothesis: Kay-Wilkoff slope parameter is \< 0.65 or \> 1.35 Alternative hypothesis: Kay-Wilkoff slope parameter is between 0.65 and 1.35||0.961|0.768|<0.001
71886030|NCT01639872|143292652|SUPERIORITY||difference in treatment means|0.014|STANDARD_ERROR_OF_MEAN|1.62||0.99|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.99
71886031|NCT01639872|143292653|SUPERIORITY||difference in treatment means|-0.32|STANDARD_ERROR_OF_MEAN|0.28||0.25|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.25
71886032|NCT06033079|143292663|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.32|2.95||||||||2.95|0.32|
71886033|NCT06033079|143292664|SUPERIORITY|||||||0.233|||||||Fisher Exact|||||||0.233
71886034|NCT06033079|143292665|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.3|2.37||||||||2.37|0.30|
71886035|NCT06033079|143292666|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.32|1.82||||||||1.82|0.32|
71886036|NCT06033079|143292667|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.34|7.51||||||||7.51|0.34|
71886037|NCT06033079|143292668|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.13|1.42||||||||1.42|0.13|
71886038|NCT06033079|143292669|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.41|7.9||||||||7.90|0.41|
71945441|NCT04608188|143414236|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71886039|NCT00546052|143292677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.74||0.999||95.0|-0.02|0.06|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.||0.06|-0.02|0.999
71886040|NCT00546052|143292678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.62||0.999||95.0|0.01|0.07|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.||0.07|0.01|0.999
71886041|NCT00546052|143292680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.95|STANDARD_DEVIATION|13.34|<|0.001||95.0|-17.62|-16.27|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg||-16.27|-17.62|<0.001
71886042|NCT00546052|143292681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.84|STANDARD_DEVIATION|8.39|<|0.001||95.0|-10.29|-9.39|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.||-9.39|-10.29|<0.001
71886043|NCT00546052|143292682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|5.4|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
71886044|NCT00546052|143292683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_DEVIATION|5.2|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||<0.001
71886045|NCT00546052|143292684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.5|STANDARD_DEVIATION|32.1||0.084|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.084
71945442|NCT00838136|143414237|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.23||||||90.0|99.88|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.60|99.88|
71945443|NCT00838136|143414238|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.87||||||90.0|99.18|104.63|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.63|99.18|
71945444|NCT00838136|143414239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.76||||||90.0|98.6|102.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.97|98.60|
71945445|NCT04958785|143414250|SUPERIORITY||Hazard Ratio (HR)|0.456||||0.1617|TWO_SIDED|95.0|0.147|1.409|||Log Rank||Hazard Ratio (HR) along with its 2-sided 95% confidence interval (CI) were estimated using the Cox proportional hazards regression model.|||1.409|0.147|0.1617
71945446|NCT04958785|143414252|SUPERIORITY||Odds Ratio (OR)|2.037|||||TWO_SIDED|95.0|0.379|10.938|||||Odds ratios and corresponding 95% CIs were estimated using chi-square test.|||10.938|0.379|
71823323|NCT00495469|143149761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.495|TWO_SIDED|95.0|-0.46|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.46|0.495
71886046|NCT00546052|143292685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|18.0||0.654|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.654
71886047|NCT00546052|143292686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|43.5||0.336|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.336
71886048|NCT00546052|143292687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|17.0||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
71886049|NCT00546052|143292688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.2|STANDARD_DEVIATION|63.8||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.001
71886050|NCT00546052|143292689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|8.7||0.613|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.||||0.613
71886051|NCT01680900|143292690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.05|TWO_SIDED|95.0|-2.6|-0.48|||Regression, Linear|||||-0.48|-2.60|0.05
71886052|NCT01680900|143292691|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71886053|NCT01680900|143292692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.05|TWO_SIDED|95.0|-0.75|-0.08|||Regression, Linear|||||-0.08|-0.75|<0.05
71886054|NCT01680900|143292696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.05|TWO_SIDED|95.0|-0.74|-0.21|||Regression, Linear|||||-0.21|-0.74|0.05
71886055|NCT01928381|143292697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5695|TWO_SIDED|95.0|-0.34|0.61|||Mixed Models Analysis|||||0.61|-0.34|0.5695
71886056|NCT01928381|143292697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.23||0.8905|TWO_SIDED|95.0|-0.43|0.49|||Mixed Models Analysis|||||0.49|-0.43|0.8905
71886057|NCT01928381|143292697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4822|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||||0.64|-0.30|0.4822
71886058|NCT01928381|143292698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2237|TWO_SIDED|95.0|-0.2|0.82|||Mixed Models Analysis||In direction of Pregabalin|||0.82|-0.20|0.2237
71945447|NCT05472038|143414307|SUPERIORITY|Superiority based on GMR was declared if the lower limit of the 2-sided 95% CI for the GMR was greater than 1.|Model-Based GMR|2.91|||||TWO_SIDED|95.0|2.45|3.44||||||||3.44|2.45|
71945448|NCT05472038|143414308|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-5%.|Adjusted Difference in Percentages|26.77|||||TWO_SIDED|95.0|19.59|33.95|||||Adjusted difference and 2-Sided CI based on the Miettinen and Nurminen method stratified by baseline NT category (\< median,\>= median) for difference in proportions. The median of baseline NT was calculated based on pooled data in 2 comparator groups.|||33.95|19.59|
71945449|NCT05472038|143414309|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.16|0.83|
71945450|NCT05472038|143414310|NON_INFERIORITY|Noninferiority based on seroresponse was declared if the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is \>-10%.|Adjusted Difference in Percentages|-3.03|||||TWO_SIDED|95.0|-9.68|3.63|||||2-Sided CI based on Miettinen and Nurminen method stratified by baseline NT category(\< median,\>= median)for difference in percentage(seroresponse rate).Median of baseline neutralizing titers was calculated based on pooled data in 2 comparator groups.|||3.63|-9.68|
71945451|NCT05472038|143414315|NON_INFERIORITY|Noninferiority based on the GMR was declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR was \>=0.8.|Model-Based GMR|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||GMR and 2-sided 95% CIs were calculated by exponentiating the difference of LS means and corresponding CIs based on the regression model included terms for baseline neutralizing titer and comparison group.|||1.56|1.22|
71945452|NCT03274687|143414347|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5.||||||0.98|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.98
71945453|NCT03274687|143414348|NON_INFERIORITY|The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6.||||||0.96|||||||t-test, 1 sided|||Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 \< -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment.||||0.96
71701296|NCT02296125|142918803|SUPERIORITY||Odds Ratio (OR)|2.78||||0.011|TWO_SIDED|95.0|1.25|6.78|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||6.78|1.25|0.0110
71886059|NCT01928381|143292698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.0978|TWO_SIDED|95.0|-0.93|0.08|||Mixed Models Analysis||In direction of Pregabain, positive control|||0.08|-0.93|0.0978
71886060|NCT01928381|143292698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.661|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||||0.40|-0.62|0.6610
71886061|NCT04770753|143292722|SUPERIORITY||Percentage difference|40.9|||<|0.0001|TWO_SIDED|95.0|32.0|49.8|||Cochran-Mantel-Haenszel|||The estimated adjusted difference in response rate, 95% CI, and p-value are based on Mantel-Haenszel stratum weighted method adjusting for the randomization stratification factors.||49.8|32.0|<0.0001
71886062|NCT04770753|143292723|SUPERIORITY||Difference in Lean Square (LS) Mean|3.4||||0.0026|TWO_SIDED|95.0|1.21|5.59|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an analysis of covariance (ANCOVA) model which includes average change from baseline in FACIT-Fatigue subscale score from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline and the randomization stratification factors as covariates.||5.59|1.21|0.0026
71886063|NCT04770753|143292724|SUPERIORITY||Difference in LS Mean|9.63|||<|0.0001|TWO_SIDED|95.0|7.8|11.46|||ANCOVA|||The estimates, 95% CIs, and 2-sided p-value are based on an ANCOVA model which includes average change from baseline in Hb concentrations from Week 12 through Week 24 as the dependent variable, treatment group as the independent variable, and baseline Hb concentration and the randomization stratification factors as covariates.||11.46|7.80|<0.0001
71886064|NCT02775851|143292746|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null pCR rate of 5% and powered the study assuming an alternative hypothesis of 25%. This single stage design had an alpha of 3.4% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 90% (probability of declaring the regimen warrants further study when the true pCR is 25%) with 25 eligible participants.||||<0.001
71886065|NCT02775851|143292747|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial|||We assumed a null CR rate of 5% and powered the study assuming an alternative hypothesis of 20%. This single stage design had an alpha of 8.5% (i.e. probability of declaring the regimen warrants further study when the true CR is 5%) and a power of 82% (probability of declaring the regimen warrants further study when the true CR is 20%) with 21 eligible participants.||||<0.001
71886066|NCT06523491|143292757|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||No sample size calculation was performed. In the survey took part 57 patients from the parent study and OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at the end of 12-month follow-up (EOF) visit was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
71886067|NCT06523491|143292757|SUPERIORITY||LS-means difference|353.18|STANDARD_ERROR_OF_MEAN|72.27||0|TWO_SIDED|95.0|178.91|527.45||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||527.45|178.91|0.00
71886068|NCT06523491|143292757|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
71886069|NCT06523491|143292757|SUPERIORITY||LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
71945454|NCT03274687|143414349|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||End of RT||||0.70
71886070|NCT06523491|143292757|SUPERIORITY||F value|23.31||||0|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of 1 and 2 NOLTREX courses with placebo was used ANCOVA adjusted for the baseline value with fixed factor of treatment group"||The between-group comparison of changes from baseline (study 1 visit 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.00
71886071|NCT06523491|143292757|SUPERIORITY||LS-means difference|-292.19|STANDARD_ERROR_OF_MEAN|78.04||0|TWO_SIDED|95.0|-480.37|-104.01|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-104.01|-480.37|0.00
71886072|NCT06523491|143292757|SUPERIORITY||[LS-means difference|-645.37|STANDARD_ERROR_OF_MEAN|95.68||0|TWO_SIDED|95.0|-876.07|-414.67||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||-414.67|-876.07|0.00
71886073|NCT03266016|143292762|SUPERIORITY||Odds Ratio (OR)|1.67||||0.045|TWO_SIDED|95.0|1.01|2.77|||Proportional Odds Logistic Regression|||This analysis is comparing length of weaning between REDvent acute group and control acute group.||2.77|1.01|.045
71886074|NCT03266016|143292762|SUPERIORITY||Proportional odds logistic regression|1.3|||||TWO_SIDED|95.0|0.7|2.6||||||Weaning Phase||2.6|0.7|
71886075|NCT03266016|143292763|SUPERIORITY||Incident rate ratio|1.03|||||TWO_SIDED|95.0|0.84|1.25|||||Negative binomial model.|||1.25|0.84|
71886076|NCT03266016|143292764|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.7||||||||2.7|0.4|
71886077|NCT03266016|143292765|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.44|2.47||||||||2.47|0.44|
71886078|NCT03266016|143292766|SUPERIORITY||Proportional odds logistic regression|1.6|||||TWO_SIDED|95.0|1.01|2.55||||||||2.55|1.01|
71886079|NCT05064059|143292798|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4183|TWO_SIDED|95.0|0.8|1.2||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.20|0.80|0.4183
71886080|NCT05064059|143292799|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.9967|TWO_SIDED|95.0|1.09|1.64||One-sided nominal p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.64|1.09|0.9967
71886081|NCT05064059|143292800|SUPERIORITY||Difference in percentage|5.9||||0.0007|TWO_SIDED|95.0|2.5|10.1||One-sided, nominal p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen Method||Difference in percentage and 95% CI were based on the Miettinen \& Nurminen method stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||10.1|2.5|0.0007
71886082|NCT05064059|143292804|OTHER||Difference in Least Square (LS) Means|-3.08||||0.1318|TWO_SIDED|95.0|-7.09|0.93||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||0.93|-7.09|0.1318
71886083|NCT05064059|143292805|OTHER||Difference in LS Means|-0.95||||0.637|TWO_SIDED|95.0|-4.93|3.02||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||3.02|-4.93|0.6370
71886084|NCT05064059|143292806|OTHER||Difference in LS Means|3.86||||0.1846|TWO_SIDED|95.0|-1.85|9.57||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||9.57|-1.85|0.1846
71886085|NCT05064059|143292807|OTHER||Difference in LS Means|0.56||||0.841|TWO_SIDED|95.0|-4.96|6.08||Two-sided p-value based on t-test.|t-test, 2 sided||Calculated using a cLDA model with PRO scores as response variable with covariates for treatment by study visit interaction \& stratified by geographic region, presence of liver metastasis \& time from diagnosis of metastatic disease to randomization.|||6.08|-4.96|0.8410
71886086|NCT05064059|143292808|OTHER||Hazard Ratio (HR)|1.0||||0.5094|TWO_SIDED|95.0|0.64|1.58||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||1.58|0.64|0.5094
71886087|NCT05064059|143292809|OTHER||Hazard Ratio (HR)|1.51||||0.9704|TWO_SIDED|95.0|0.98|2.33||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.33|0.98|0.9704
71886088|NCT05064059|143292810|OTHER||Hazard Ratio (HR)|1.82||||0.9905|TWO_SIDED|95.0|1.11|2.98||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization.|||2.98|1.11|0.9905
71945455|NCT03274687|143414349|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||6 months||||0.67
71945456|NCT03274687|143414349|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||1 year||||0.66
71945457|NCT03274687|143414350|SUPERIORITY|||||||0.0011|||||||t-test, 2 sided|||End of RT||||0.0011
71945458|NCT03274687|143414350|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||6 months||||0.93
71945459|NCT03274687|143414350|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||1 year||||0.30
71945460|NCT03274687|143414351|SUPERIORITY|||||||0.29|||||||Gray's test|Two-sided significance level 0.05||Protocol definition of biochemical failure||||0.29
71945461|NCT03274687|143414351|SUPERIORITY|||||||0.22|||||||Gray's test|Two-sided significance level 0.05||Phoenix definition of biochemical failure||||0.22
71945462|NCT03274687|143414352|SUPERIORITY|||||||0.96||||||Two-sided significance level 0.05|Gray's test|||||||0.96
71945463|NCT03274687|143414353|SUPERIORITY|||||||0.35||||||Two-sided significance level 0.05|Gray's test|||||||0.35
71945464|NCT03274687|143414354|SUPERIORITY|||||||0.41||||||Two-sided significance level 0.05|Gray's test|||||||0.41
71886089|NCT05064059|143292811|OTHER||Hazard Ratio (HR)|1.86||||0.9853|TWO_SIDED|95.0|1.06|3.26||One-sided p-value based on log-rank test stratified by geographic region (Asia Pacific; EMEA/Americas), presence of liver metastasis (Yes/No) and time from initial diagnosis of metastatic disease to randomization (\>=18 months, \<18 months).|Log Rank||HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, presence of liver metastasis \& time from initial diagnosis of metastatic disease to randomization|||3.26|1.06|0.9853
71886090|NCT00805740|143292834|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.8|||||TWO_SIDED|95.0|-12.3|53.3||||||The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||53.3|-12.3|
71886091|NCT00805740|143292835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.6|||||TWO_SIDED|95.0|-13.6|55.6||||||2-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.6|-13.6|
71701297|NCT02296125|142918803|OTHER|The china cohort was not powered for superiority|Odds Ratio (OR)|1.67||||0.5772|TWO_SIDED|95.0|0.27|12.98|||Regression, Logistic||An odds ratio \>1 favours osimertinib|||12.98|0.27|0.5772
71886092|NCT00805740|143292835|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1|||||TWO_SIDED|95.0|-23.3|47.3||||||6-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||47.3|-23.3|
71886093|NCT00805740|143292837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.1|||||TWO_SIDED|95.0|-39.0|27.9||||||The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||27.9|-39.0|
71886094|NCT03823391|143292892|SUPERIORITY||Least Squares (LS) Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.215||0.022|TWO_SIDED|90.0|-0.89|-0.15|||Mixed-effect model repeated measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Between groups difference was a single-arm comparison of LS mean of ABBV-3373 estimated from the MMRM model above minus the historical mean of adalimumab (-2.13).|Two primary comparisons were performed between ABBV-3373 and adalimumab. The first was the comparison of ABBV-3373 to historical adalimumab reference value -2.13 based on a meta-analysis consisting of 242 subjects from 3 historical adalimumab studies in which the success criterion was 2-sided P value ≤ 0.1.||-0.15|-0.89|0.022
71945465|NCT03274687|143414355|SUPERIORITY|||||||0.6||||||Two-sided significance level 0.05|Gray's test|||||||0.60
71945466|NCT03274687|143414357|SUPERIORITY||Hazard Ratio (HR)|1.58||||0.61|TWO_SIDED|95.0|0.26|9.47||Two-side significance level 0.05|Log Rank||Reference = COPORT|||9.47|0.26|0.61
71945467|NCT03274687|143414358|SUPERIORITY|||||||0.53|||||||Chi-squared|||Patients with any grade 3 or higher adverse event of any attribution||||0.53
71945468|NCT03274687|143414358|SUPERIORITY|||||||0.6929|||||||Chi-squared|||Patients with any grade 3 or higher gastrointestinal adverse event of any attribution||||0.6929
71701298|NCT02296125|142918804|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0025|TWO_SIDED|95.0|-11.205|-2.403|||Regression, Linear|||||-2.403|-11.205|0.0025
71945469|NCT03274687|143414358|SUPERIORITY|||||||0.2605|||||||Chi-squared|||Patients with any grade 3 or higher genitourinary adverse event of any attribution||||0.2605
71701299|NCT02296125|142918804|OTHER|The china cohort was not powered for superiority|Mean Difference (Final Values)|-6.59||||0.1348|TWO_SIDED|95.0|-15.246|2.072|||Regression, Linear|||||2.072|-15.246|0.1348
71886095|NCT03823391|143292892|SUPERIORITY|||||||0.899||||||Posterior probability|Historical data borrowing|Based on posterior distribution of means for each group, the probability of Treatment mean - Control mean \< 0 given the observed data was calculated.||The second comparison was ABBV-3373 to adalimumab with combined in-trial and borrowed historical adalimumab data using a Bayesian historical borrowing approach in which the success criterion was posterior probability of ABBV-3373 being better than adalimumab \> 95%. When borrowing 30 historical adalimumab subjects, the combined least squares mean change from Baseline was -2.29.||||0.899
71945470|NCT04934722|143414384|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.24|2.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.34|0.24|
71945471|NCT04934722|143414385|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.3|6.01|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||6.01|0.30|
71945472|NCT04934722|143414386|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.5|3.63|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.63|0.50|
71945473|NCT04934722|143414388|OTHER||Hazard Ratio (HR)|3.15|||||TWO_SIDED|95.0|0.33|30.29|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||30.29|0.33|
71886096|NCT03823391|143292892|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.353||0.683|TWO_SIDED|90.0|-0.74|0.45|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|The mean difference in change from Baseline in DAS28 (CRP) at Week 12 between ABBV-3373 and adalimumab was also estimated only based on in-study data.||0.45|-0.74|0.683
71886097|NCT03823391|143292893|SUPERIORITY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|3.207||0.601|TWO_SIDED|90.0|-7.08|3.7|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||3.70|-7.08|0.601
71886098|NCT03823391|143292894|SUPERIORITY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|3.205||0.737|TWO_SIDED|90.0|-6.47|4.3|||Mixed Effect Model Repeated Measurement|Analysis includes treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||4.30|-6.47|0.737
71886099|NCT03823391|143292895|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.418||0.612|TWO_SIDED|90.0|-0.92|0.49|||Mixed Effect Model Repeated Measurement|Analysis included treatment, visit, stratification factors, and treatment-by-visit interaction as fixed factors and Baseline value as covariate.|Treatment difference = ABBV-3373 - Adalimumab|||0.49|-0.92|0.612
71886100|NCT03823391|143292896|SUPERIORITY||Response Rate Difference|-4.0||||0.877|TWO_SIDED|90.0|-28.5|20.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||20.5|-28.5|0.877
71945474|NCT04934722|143414389|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.11|4.07|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||4.07|0.11|
71945475|NCT04934722|143414390|OTHER||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.73|2.9|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.90|0.73|
71945476|NCT04934722|143414391|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.34|||||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate.|||7.34|0.42|
71945477|NCT04934722|143414392|OTHER||Percent Difference|-5.5|||||TWO_SIDED|95.0|-12.6|0.0|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||0.0|-12.6|
71701300|NCT02296125|142918805|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.0462|TWO_SIDED|95.0|0.6409|0.9963|||Log Rank|||||0.9963|0.6409|0.0462
71945478|NCT04934722|143414393|OTHER||Percent difference|-0.7|||||TWO_SIDED|95.0|-15.0|13.7|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||13.7|-15.0|
71823324|NCT00495469|143149761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.261|TWO_SIDED|95.0|-0.52|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.14|-0.52|0.261
71945479|NCT04934722|143414394|OTHER||Percent difference|7.8|||||TWO_SIDED|95.0|-12.5|27.1|||||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method.|||27.1|-12.5|
71945480|NCT03653507|143414413|SUPERIORITY||Hazard Ratio (HR)|0.689||||0.0005|TWO_SIDED|95.0|0.552|0.86|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.860|0.552|0.0005
71945481|NCT03653507|143414414|SUPERIORITY||Hazard Ratio (HR)|0.763||||0.0047|TWO_SIDED|95.0|0.622|0.936|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||0.936|0.622|0.0047
71945482|NCT03653507|143414415|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.4654|TWO_SIDED|95.0|0.772|1.328|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.328|0.772|0.4654
71945483|NCT03653507|143414416|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.4478|TWO_SIDED|95.0|0.673|1.577|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.577|0.673|0.4478
71945484|NCT03653507|143414417|SUPERIORITY||Hazard Ratio (HR)|0.869||||0.167|TWO_SIDED|95.0|0.655|1.153|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.153|0.655|0.1670
71945485|NCT03653507|143414418|SUPERIORITY|||||||0.2219||||||Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.|Cochran-Mantel-Haenszel|||||||0.2219
71945486|NCT03653507|143414419|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0826|TWO_SIDED|95.0|0.552|1.105|||Log Rank||Log-rank test stratified by:\* Region (Asia vs Non-Asia), \* Number of organs with metastatic sites (0 to 2 vs \>= 3), \* Prior gastrectomy (Yes or No)|||1.105|0.552|0.0826
71701301|NCT02296125|142918805|OTHER|The china cohort was not powered for superiority|Hazard Ratio (HR)|0.848||||0.4416|TWO_SIDED|95.0|0.5568|1.291|||Log Rank|||||1.2910|0.5568|0.4416
71823325|NCT00495469|143149761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.446|TWO_SIDED|95.0|-0.46|0.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.20|-0.46|0.446
71886101|NCT03823391|143292897|SUPERIORITY||Response Rate Difference|-13.1||||0.426|TWO_SIDED|90.0|-37.2|11.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors.|Response rate difference = ABBV-3373 - Adalimumab|||11.0|-37.2|0.426
71886102|NCT05030311|143292906|SUPERIORITY||Mean Difference (Final Values)|-6.22|STANDARD_ERROR_OF_MEAN|1.136|<|0.001|TWO_SIDED|95.0|-8.45|-4.0|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|||-4.00|-8.45|<0.001
71886103|NCT05030311|143292907|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.544|<|0.001|TWO_SIDED|95.0|-3.7|-1.56|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|ISS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-1.56|-3.70|<0.001
71945487|NCT00594997|143414429|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||p\<0.05 threshold for statistical significance|Regression, Linear|||||||<0.0001
71945488|NCT05381948|143414440|OTHER||Least Square (LS) Mean|-0.12|STANDARD_ERROR_OF_MEAN|1.199||0.919|TWO_SIDED|95.0|-2.48|2.24|||Mixed Model for Repeated Measures (MMRM)|||||2.24|-2.48|0.919
71945489|NCT05381948|143414440|OTHER||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|1.187||0.795|TWO_SIDED|95.0|-2.63|2.02|||MMRM|||||2.02|-2.63|0.795
71945490|NCT04198428|143414454|SUPERIORITY||Odds Ratio (OR)|1.49|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
71945491|NCT04198428|143414455|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
71945492|NCT04198428|143414456|SUPERIORITY||Odds Ratio (OR)|1.43|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
71945493|NCT04198428|143414457|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Zero-inflated negative binomial mixed-model regression adjusted for site and clinic factors balanced at randomization||||||<0.05
71945494|NCT04198428|143414458|SUPERIORITY||Risk Ratio (RR)|0.93|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
71823326|NCT00495469|143149761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.783|TWO_SIDED|95.0|-0.29|0.38||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.38|-0.29|0.783
71945495|NCT04198428|143414459|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors||||||<0.05
71945496|NCT04198428|143414460|SUPERIORITY||Mean Difference (Net)|-1068.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index costs in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
71945497|NCT04198428|143414461|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71945498|NCT04198428|143414462|SUPERIORITY||Risk Ratio (RR)|1.08|||<|0.05|TWO_SIDED||||||Mixed Models Analysis||Generalized estimating equation comparing post- to pre-index rates in OUD-CDS vs. Usual Care, adjusted for site and balancing factors|||||<0.05
71945499|NCT04396860|143414463|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.96|TWO_SIDED|95.0|0.98|2.21|||Log Rank|Stratified log-rank|Reference level = Arm 1|For the phase II endpoint, observation of 100 PFS events among the 150 randomized patients (from both arms) provides 95% statistical power to detect an improvement in median PFS from 5.7 months in the control arm to 9.7 months in the experimental arm, corresponding to a hazard reduction of 42% (hazard ratio 0.58) at one-sided significance level of 0.15 (and 87% power for hazard ratio of 0.65 at this same alpha).||2.21|0.98|0.96
71945500|NCT05104476|143414481|SUPERIORITY||Bayesian Progression Model|0.81|||||TWO_SIDED|95.0|0.56|1.13|||||Reported here is the estimated effect parameter from the Bayesian Progression Model and the associated Credibility Interval for the active arm.|||1.13|0.56|
71945501|NCT04649359|143414500|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 30%.||||<0.0001
71945502|NCT04649359|143414500|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort B was 15%.||||<0.0001
71945503|NCT04649359|143414501|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 12%.||||<0.0001
71945504|NCT04649359|143414502|OTHER||||||<|0.0001|||||||Exact binominal|||Null hypothesis of ORR by BICR for cohort A was 38%.||||<0.0001
71945505|NCT04008030|143414537|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||0.0003|TWO_SIDED|95.0|0.48|0.81||Boundary for statistical significance p-value \< 0.0095.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.81|0.48|0.0003
71945506|NCT04008030|143414538|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.14|0.32||Boundary for statistical significance p-value \< 0.0209.|Log Rank|Log-rank test stratified by the same factors as used in the Cox proportional hazard model.|From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.32|0.14|<0.0001
71945507|NCT04008030|143414540|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
71945508|NCT04008030|143414541|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.32|||||TWO_SIDED|95.0|0.23|0.46|||||From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.|||0.46|0.23|
71945509|NCT04008030|143414543|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.6||||||95.0|0.45|0.8|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.80|0.45|
71945510|NCT04008030|143414544|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.63||||||95.0|0.48|0.83|||||from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.|||0.83|0.48|
71945511|NCT04008030|143414545|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
71945512|NCT04008030|143414546|SUPERIORITY|Arm B over Arm C|Hazard Ratio (HR)|0.2||||||95.0|0.12|0.31|||||From a stratified Cox proportional hazard model by tumor sidedness (left vs. right) as entered into the IRT.|||0.31|0.12|
71945513|NCT04008030|143414547|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.64||||||95.0|0.52|0.79|||||from a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.79|0.52|
71945514|NCT04008030|143414548|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.62||||||95.0|0.48|0.8|||||Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.80|0.48|
71823327|NCT00495469|143149761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.21||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.21|-0.46|0.454
71945515|NCT04008030|143414550|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.77||||0.0011||95.0|1.26|2.5||Boundary for statistical significance p-value \< 0.006|Cochran-Mantel-Haenszel|Two-sided p-value from stratified CMH Test.|||Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT|2.50|1.26|0.0011
71945516|NCT04008030|143414551|SUPERIORITY|Arm B over Arm C|Odds Ratio (OR)|7.02||||||95.0|3.91|12.62|||||Stratified by tumor sidedness (left vs. right)|||12.62|3.91|
71945517|NCT04008030|143414551|SUPERIORITY|Arm B over Arm A|Odds Ratio (OR)|1.67||||||95.0|1.06|2.63|||||Stratified by tumor sidedness (left vs. right)|||2.63|1.06|
71945518|NCT04008030|143414552|SUPERIORITY|Arm B over Arm A|Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||From a Cox Model stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \>= 2) as entered into the IRT.|||0.83|0.45|
71945519|NCT02869867|143414591|SUPERIORITY||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.09|4.31|||Mixed Models Analysis|||||4.31|2.09|<0.001
71945520|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945521|NCT02069366|143414599|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
71945522|NCT02069366|143414599|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS+E vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U)||||0.040
71945523|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Amygdala- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945524|NCT02069366|143414599|SUPERIORITY|||||||0.041||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Extinction Learning CS- Hippocampus- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.041
71945525|NCT02069366|143414599|SUPERIORITY|||||||0.04||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus time factors.||This analysis corresponds to the row 'Extinction Learning CS- vmPFC- Visit 3' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.040
71945526|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945527|NCT02069366|143414599|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
71945528|NCT02069366|143414599|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+E vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
71945529|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945530|NCT02069366|143414599|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
71945531|NCT02069366|143414599|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
71945532|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945533|NCT02069366|143414599|SUPERIORITY|||||||0.027||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.027
71945534|NCT02069366|143414599|SUPERIORITY|||||||0.019||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Recall CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.019
71945535|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945536|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E Hippocampus- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945537|NCT02069366|143414599|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+E vmPFC- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
71945538|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Amygdala- Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945539|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945540|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS- vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945541|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Amygdala-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945542|NCT02069366|143414599|SUPERIORITY||||||>|0.05||||||RM-ANOVA. Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U Hippocampus-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||>0.05
71945543|NCT02069366|143414599|SUPERIORITY|||||||0.025||||||Repeated-measures ANOVA (SPM12, ROI small-volume corrected). Significance threshold p\<0.05, FWE-corrected.|ANOVA|RM-ANOVA with group and stimulus factors.||This analysis corresponds to the row 'Renewal CS+U vmPFC-Visit 4' in the Brain Measures outcome table. RM-ANOVA including stimulus (CS+E, CS-, CS+U).||||0.025
71945544|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945545|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945546|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS-Early- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945547|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+E Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945548|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS+U Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945549|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Acquisition CS- Late- Visit 2' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945550|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945551|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Early- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945552|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS+E Late-Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945553|NCT02069366|143414600|SUPERIORITY|||||||0.04||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10.||This analysis corresponds to the row 'Extinction CS- Late- Visit 3' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.04
71945554|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945555|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945556|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945557|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945558|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945559|NCT02069366|143414600|SUPERIORITY|||||||0.033||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Recall CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||0.033
71945560|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945561|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945562|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Early-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945563|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+E Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945564|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS+U Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945565|NCT02069366|143414600|SUPERIORITY||||||>|0.05||||||Chi-square test of independence; significance threshold p\<0.05.|Chi-squared|3 (response categories) × 6 (groups) contingency table; df=10||This analysis corresponds to the row 'Renewal CS- Late-Visit 4' in the Expectancy Ratings outcome table. Chi-square test comparing distribution of Yes/No/I don't know responses across 6 groups.||||>0.05
71945566|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Pre- Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945567|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Mid-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945568|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Extinction Learning Post-Visit 3' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945569|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945570|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945571|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Recall Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945572|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Pre-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945573|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Mid-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945574|NCT02069366|143414601|SUPERIORITY||||||>|0.05||||||Significance threshold p\<0.05.|ANOVA|Group factor at specified phase/timepoint.||This analysis corresponds to the row 'Renewal Post-Visit 4' in the SUDS outcome table. ANOVA comparing mean SUDS ratings across 6 groups at the specified phase/timepoint.||||>0.05
71945575|NCT04516967|143414602|SUPERIORITY|||||||0.0077|||||||Fisher Exact|||||||0.0077
71945576|NCT04516967|143414603|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71945577|NCT04516967|143414604|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71945578|NCT04516967|143414605|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71945579|NCT04516967|143414606|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71945580|NCT04516967|143414607|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
71945581|NCT04516967|143414608|SUPERIORITY|||||||0.7175|||||||Fisher Exact|||||||0.7175
71945582|NCT03570749|143414609|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|2.75|12.02|||Regression, Logistic|||||12.02|2.75|<0.001
71945583|NCT03570749|143414609|SUPERIORITY||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|5.89|23.62|||Regression, Logistic|||||23.62|5.89|<0.001
71945584|NCT03570749|143414610|SUPERIORITY||Odds Ratio (OR)|3.92|||<|0.001|TWO_SIDED|95.0|1.81|8.51|||Regression, Logistic|||||8.51|1.81|<0.001
71945585|NCT03570749|143414610|SUPERIORITY||Odds Ratio (OR)|10.26|||<|0.001|TWO_SIDED|95.0|5.05|20.87|||Regression, Logistic|||||20.87|5.05|<0.001
71945586|NCT03570749|143414611|SUPERIORITY||Odds Ratio (OR)|5.58||||0.001|TWO_SIDED|95.0|1.97|15.83|||Regression, Logistic|||||15.83|1.97|0.001
71945587|NCT03570749|143414611|SUPERIORITY||Odds Ratio (OR)|14.34|||<|0.001|TWO_SIDED|95.0|5.3|38.83|||Regression, Logistic|||||38.83|5.30|<0.001
71945588|NCT03570749|143414612|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|2.72|39.3|||Regression, Logistic|||||39.30|2.72|<0.001
71945589|NCT03570749|143414612|SUPERIORITY||Odds Ratio (OR)|18.47|||<|0.001|TWO_SIDED|95.0|5.04|67.68|||Regression, Logistic|||||67.68|5.04|<0.001
71945590|NCT03570749|143414613|SUPERIORITY||Odds Ratio (OR)|6.6|||<|0.001|TWO_SIDED|95.0|2.34|18.62|||Regression, Logistic|||||18.62|2.34|<0.001
71945591|NCT03570749|143414613|SUPERIORITY||Odds Ratio (OR)|13.58|||<|0.001|TWO_SIDED|95.0|5.01|36.81|||Regression, Logistic|||||36.81|5.01|<0.001
71945592|NCT03570749|143414614|SUPERIORITY||Odds Ratio (OR)|4.63||||0.012|TWO_SIDED|95.0|1.41|15.27|||Regression, Logistic|||||15.27|1.41|0.012
71945593|NCT03570749|143414614|SUPERIORITY||Odds Ratio (OR)|14.42|||<|0.001|TWO_SIDED|95.0|4.73|43.93|||Regression, Logistic|||||43.93|4.73|<0.001
71945594|NCT03570749|143414615|SUPERIORITY||Mean Difference (Final Values)|-23.1|STANDARD_ERROR_OF_MEAN|3.806|<|0.001|TWO_SIDED|95.0|-30.57|-15.63|||ANCOVA|||||-15.63|-30.57|<0.001
71945595|NCT03570749|143414615|SUPERIORITY||Mean Difference (Final Values)|-37.65|STANDARD_ERROR_OF_MEAN|3.447|<|0.001|TWO_SIDED|95.0|-44.24|-30.89|||ANCOVA|||||-30.89|-44.24|<0.001
71945596|NCT03570749|143414616|SUPERIORITY||Odds Ratio (OR)|2.31||||0.047|TWO_SIDED|95.0|1.01|5.29|||Regression, Logistic|||||5.29|1.01|0.047
71945597|NCT03570749|143414616|SUPERIORITY||Odds Ratio (OR)|6.03|||<|0.001|TWO_SIDED|95.0|2.91|12.51|||Regression, Logistic|||||12.51|2.91|<0.001
71945598|NCT03570749|143414618|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.288||0.005|TWO_SIDED|95.0|-1.38|-0.25|||ANCOVA|||||-0.25|-1.38|0.005
71945599|NCT03570749|143414618|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.261||0.04|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||||-0.02|-1.05|0.040
71945600|NCT03570749|143414619|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.259||0.107|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||||0.09|-0.93|0.107
71945601|NCT03570749|143414619|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.234||0.174|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||||0.14|-0.78|0.174
71945602|NCT04191499|143414648|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.32|0.59|||Log Rank|||Hazard ratios were estimated by Cox regression. Hazard ratios and log-rank p-values are using stratified methods by stratifying Visceral Disease, Endocrine Resistance, and Region.||0.59|0.32|<0.0001
71945603|NCT02469155|143414668|SUPERIORITY||Least Squares Mean Difference|0.1||||0.972|TWO_SIDED|95.0|-3.39|3.51|||Mixed Models for Repeated Measure|||||3.51|-3.39|0.972
71945604|NCT02469155|143414668|SUPERIORITY||Least Squares Mean Difference|0.5||||0.789|TWO_SIDED|95.0|-2.92|3.84|||Mixed Effects Model for Repeated Measure|||||3.84|-2.92|0.789
71945605|NCT05615935|143414700|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|2.07|||<|0.001|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||Using G\*Power 3.1, the required sample size for ANCOVA with two groups was estimated with a significance level of 0.05, statistical power of 0.80, and an effect size of 0.35, based on Cohen's guidelines for a medium-to-large effect commonly applied in behavioral research (Cohen, 1988). Assuming up to two covariates, a minimum of 67 participants was required. Accounting for a 10% attrition rate, the final target was set at 74 participants.||||<0.001
71945606|NCT05615935|143414701|SUPERIORITY||Adjusted Mean Difference (ANCOVA)|4.58||||0.15|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|ANCOVA|||||||0.15
71945607|NCT05615935|143414701|SUPERIORITY||Median Difference (Final Values)|-2.64|STANDARD_DEVIATION|6.35||0.02|TWO_SIDED|||||The p-value is adjusted for multiple comparisons using the Bonferroni correction, with a significance threshold of 0.05.|t-test, 2 sided|||||||0.02
71945608|NCT02282761|143414710|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.83||0.182|TWO_SIDED|95.0|-6.17|1.05|||Mixed Effects Model for Repeated Measure|||||1.05|-6.17|0.182
71945609|NCT02282761|143414710|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.82||0.045|TWO_SIDED|95.0|-7.75|-0.6|||Mixed Effects Model for Repeated Measure|||||-0.60|-7.75|0.045
71945610|NCT02282761|143414711|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.045|TWO_SIDED|95.0|-0.54|-0.12|||Mixed Effects Model for Repeated Measure|||||-0.12|-0.54|0.045
71945611|NCT03742037|143414741|SUPERIORITY||LS mean difference to placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.54||0.4749|TWO_SIDED|95.0|-1.45|0.68|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.68|-1.45|0.4749
71945612|NCT03742037|143414741|SUPERIORITY||LS mean to placebo|-0.57|STANDARD_ERROR_OF_MEAN|0.54||0.2941|TWO_SIDED|95.0|-1.65|0.49|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||0.49|-1.65|0.2941
71945613|NCT03742037|143414741|SUPERIORITY||LS mean difference to placebo|0.01|STANDARD_ERROR_OF_MEAN|0.54||0.9802|TWO_SIDED|95.0|-1.05|1.08|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||1.08|-1.05|0.9802
71945614|NCT03742037|143414741|SUPERIORITY||LS mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.54||0.0291|TWO_SIDED|95.0|-2.25|-0.12|||Mixed Models Analysis|||The analysis was performed on the Full Analysis Set (FAS). The FAS included all participants who were randomized. Baseline was defined as the last measurement before randomization.||-0.12|-2.25|0.0291
71945615|NCT03742037|143414742|SUPERIORITY||Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||1.9|0.54|0.974
71945616|NCT03742037|143414742|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2845|TWO_SIDED|95.0|0.75|2.65|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.65|0.75|0.2845
71945617|NCT03742037|143414742|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
71945618|NCT03742037|143414742|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5115|TWO_SIDED|95.0|0.66|2.32|||Mixed Models Analysis|||A generalized mixed effects model for repeated measures was applied to the SRI-4 response from Month 1 through 6 with treatment group, month, treatment group by month interaction, and stratification factors (oral corticosteroids dose \& mSLEDAI-2K) as fixed effects \& participant as random effect.||2.32|0.66|0.5115
71945619|NCT04600414|143414767|SUPERIORITY||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.38|||Multi-level model to account for cluster|||||0.38|0.03|<0.001
71945620|NCT04600414|143414768|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.532|TWO_SIDED|95.0|-4.97|2.57|||Multi-level model to account for cluster|||||2.57|-4.97|0.532
71945621|NCT05446870|143414776|OTHER||Posterior probability (%)|100.0|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of pCR, adjusted for baseline ctDNA and treatment assignment.|||
71945622|NCT05446870|143414778|OTHER||Posterior probability (%)|90.99|||||||||||||||Posterior probability (based on 20000 sets of model parameters) ctDNA fold change (square root scale) coefficient less than zero in the multivariable logistic regression model of CRS (CRS3 coded as 1 and CRS1 or 2 coded as 0), adjusted for baseline ctDNA and treatment assignment.|||
71945623|NCT05446870|143414779|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% confidence interval (CI) were based on Miettinen \& Nurminen method.|Difference in Percentage|1.1|||||TWO_SIDED|95.0|-10.0|12.9||||||||12.9|-10.0|
71945624|NCT05446870|143414780|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC + MK-4830 arm - % Pembrolizumab + SOC arm) and 95% CI were based on Miettinen \& Nurminen method.|Difference in Percentage|20.7|||||TWO_SIDED|95.0|3.5|37.0||||||||37.0|3.5|
71945625|NCT05446870|143414783|OTHER||Posterior probability (%)|38.75|||||||||||||||Posterior probability (based on 20000 sets of model parameters) coefficient for treatment assignment (MK-4830 containing vs. not) less than zero in Bayesian parametrization of the constrained longitudinal data analysis (cLDA) model, modeling ctDNA value at Cycle 3 and ctDNA value at baseline as bivariate normal.|||
71945626|NCT01842360|143414845|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71945627|NCT01842360|143414846|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Poisson|||||||<0.001
71945628|NCT01842360|143414847|SUPERIORITY|||||||0.0094|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean of health care consumption was 17.5±34.7 points in the placebo group versus 9.2±27.9 points in the MV130 group.||||0.0094
71945629|NCT01842360|143414848|SUPERIORITY|||||||0.3917|TWO_SIDED|95.0|||||Log Rank|||||||0.3917
71945630|NCT01842360|143414849|SUPERIORITY|||||||0.0232|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||As for the previous index the number of days with any of these drugs is used.||||0.0232
71945631|NCT01842360|143414850|SUPERIORITY|||||||0.0319|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0319
71945632|NCT01842360|143414851|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
71945633|NCT01842360|143414852|SUPERIORITY|||||||0.0037|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of emergency room visits was 0.37 (±1.15) for the MV130 group and 0.87 (±1.61) for the placebo group.||||0.0037
71945634|NCT01842360|143414853|SUPERIORITY|||||||0.1008|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The mean number of medical consultations was 0.08 (±0.31) for the MV130 group and 0.31 (±0.88) for the placebo group.||||0.1008
71945635|NCT01842360|143414854|SUPERIORITY|||||||0.0367|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.0367
71945636|NCT01842360|143414856|SUPERIORITY|||||||0.3234|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3234
71945637|NCT01842360|143414857|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
71945638|NCT02446600|143414859|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.077|TWO_SIDED|95.0|0.663|1.105||The p-value is one-sided. Per the protocol, the statistical significance threshold was \<0.025. Type 1 error was controlled using hierarchical testing strategy.|Log Rank|The log rank test was stratified by the minimization factors provided at randomization|The hazard ratio estimate compares olaparib+cedirinib to chemotherapy. If olaparib+cedirinib is superior, the hazard ratio is \<1.0.|Arm II was suspended for futility at the interim analysis so was not analyzed at the final analysis.||1.105|0.663|0.077
71945639|NCT04551053|143414865|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.8||||0.2567|TWO_SIDED|95.0|0.65|5.02||CMH test for un-equality stratified by Dynamic International Prognostic Scoring System (DIPSS) category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/Liters \[L\] versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||5.02|0.65|0.2567
71945640|NCT04551053|143414866|SUPERIORITY|p-value for superiority is half of the CMH p-value.|Odds Ratio (OR)|1.34||||0.5349|TWO_SIDED|95.0|0.53|3.39||calculated from Cochran Mantel-Haenszel test for un-equality stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 × 10\^9/L versus 50 to \<100 × 10\^9/L inclusive)|Cochran-Mantel-Haenszel|||||3.39|0.53|0.5349
71945641|NCT04551053|143414868|SUPERIORITY|||||||0.2224||||||calculated from log-rank test stratified by DIPSS category (intermediate 1 versus intermediate 2 and high) and Baseline platelet count (≥100 x 10\^9/L versus 50 to \<100 x 10\^9/L inclusive)|Log Rank|||||||0.2224
71945642|NCT01935934|143414892|OTHER||||||||||||||||||"Trial design discriminated between co-primary endpoints of objective RR of 30% (vs 10%) and 12-week PFS of 55% (vs 30%). The design had 86% power to detect a true objective RR of at least 30% and at least 90% power to detect a true 12-week PFS rate of atleast 55% (or a median PFS of 3.4 months).~The parallel exploratory cohort of uncommon histology cancers was analyzed independently."|||
71945643|NCT04016415|143414898|SUPERIORITY|Two-sided tests with the null hypothesis of no difference in chg from Baseline to 6MO between the two arms. The power calculation assumed a clinically meaningful diff of 0.5% and standard deviation of 0.9%. Assuming an avg class cohort size of 18 pts and an intraclass correlation coefficient estimate of 0.08 for correlation within cohorts yielded a design effect that inflated the sample size by 1+((18-1) multiplied by 0.08)=2.36. A 15% dropout rate was assumed. 145 pts per arm yielded 80% power.|Mean Difference (Net)|-0.01||||0.96|TWO_SIDED|95.0|-0.36|0.34||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.34|-0.36|0.96
71945644|NCT04016415|143414899|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|-0.07||||0.68|TWO_SIDED|95.0|-0.38|0.25||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.25|-0.38|0.68
71945645|NCT04016415|143414900|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|0.06||||0.41|TWO_SIDED|95.0|-0.09|0.21||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.21|-0.09|0.41
71945646|NCT04016415|143414901|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.22|0.12||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||0.12|-0.22|0.59
71945647|NCT04016415|143414902|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 2MO between the two arms.|Mean Difference (Net)|1.57||||0.04|TWO_SIDED|95.0|0.07|3.06||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 2MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||3.06|0.07|0.04
71945648|NCT04016415|143414903|SUPERIORITY|All hypothesis tests are two-sided (any difference), with the null hypothesis of no difference in change from Baseline to 6MO between the two arms.|Mean Difference (Net)|0.83||||0.3|TWO_SIDED|95.0|-0.74|2.4||A priori significance level = 0.05; two-sided. Analyses were based upon pre-specified hypotheses, and therefore corrections for multiple testing were not made.|Mixed Models Analysis|Linear; Fixed: arm+visit\[base,2MO,6MO\]+insulin at base+(armXvisit interact); Random: subjects, cohort(arm); Residual: longitudinal repeated measures|Change = 6MO - Baseline; Difference = SME - MBSR; Contrasts were constructed from the linear mixed model to estimate the changes.|||2.40|-0.74|0.30
71945649|NCT01499563|143414911|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.4||0.017|TWO_SIDED|95.0|-11.1|-0.4|||Mixed Effects model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||-0.4|-11.1|0.017
71945650|NCT01499563|143414911|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.708|TWO_SIDED|95.0|-6.3|4.5|||Mixed Effects Model for Repeated Measure||95% CI for LS Mean difference are with Bonferroni correction|The study was powered for prespecified comparison of both doses of ITI-007 with placebo using a Bonferroni correction for multiple comparisons. The study was not statistically powered to include multiple comparisons of risperidone to placebo and thus, this comparison is not presented here.||4.5|-6.3|0.708
71945651|NCT05615870|143414915|SUPERIORITY||Mean Difference (Final Values)|5.41||||0.537|TWO_SIDED|95.0|-11.77|22.6|||Mixed Models Analysis|||Null hypothesis: mean of SFDs in the HEPA filtration home intervention group will not differ from the mean of SFDs in the control group||22.60|-11.77|0.537
71945652|NCT05615870|143414916|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.205|TWO_SIDED|95.0|-0.07|0.3|||Mixed Models Analysis|||Null hypothesis: mean of counts of hospitalizations for respiratory symptoms in the intervention group will not differ from the mean of counts of hospitalizations for respiratory symptoms in the control group||0.30|-0.07|0.205
71945653|NCT05615870|143414916|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.35|0.35|||Mixed Models Analysis|||Null hypothesis: mean of counts of emergency department or urgent care visits for respiratory symptoms in the intervention group will not differ from the mean of counts of emergency department or urgent care visits for respiratory symptoms in the control group||0.35|-0.35|0.992
71945654|NCT05615870|143414916|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.172|TWO_SIDED|95.0|-0.9|0.16|||Mixed Models Analysis|||Null hypothesis: mean of counts of other unscheduled healthcare visits for respiratory symptoms in the intervention group will not differ from the mean of counts of other unscheduled healthcare visits for respiratory symptoms in the control group||0.16|-0.90|0.172
71945655|NCT05615870|143414916|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.53|TWO_SIDED|95.0|-1.02|0.52|||Mixed Models Analysis|||Null hypothesis: mean of counts (or total counts) of visits of all metrics for respiratory symptoms in the intervention group will not differ from the mean of counts of visits of all metrics for respiratory symptoms in the control group||0.52|-1.02|0.530
71945656|NCT05615870|143414917|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.598|TWO_SIDED|95.0|-3.75|2.16|||Mixed Models Analysis|||Null hypothesis: mean of the Child QOL score in the HEPA intervention group will not differ from the mean of Child QOL score in the control group||2.16|-3.75|0.598
71945657|NCT05615870|143414918|SUPERIORITY||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.98|-3.42|||Mixed Models Analysis||The results were based on the average PM2.5 level of common room and sleep space.|Null hypothesis: the mean of the PM2.5 level of the common room and sleep space in the intervention group will not differ from the mean of the PM2.5 level in the control group||-3.42|-10.98|<0.001
71945658|NCT06466655|143414957|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71945659|NCT06466655|143414958|EQUIVALENCE||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71945660|NCT05247229|143414995|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
71945661|NCT05247229|143414995|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
71945662|NCT05247229|143414996|SUPERIORITY||Slope|-0.42||||0.12|TWO_SIDED|95.0|-0.96|0.11|||Chi-squared|||Q6 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.11|-0.96|0.12
71945663|NCT05247229|143414996|SUPERIORITY||Slope|0.41||||0.21|TWO_SIDED|95.0|-0.23|1.05|||Chi-squared|||Q7 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.05|-0.23|0.21
71945664|NCT05247229|143414996|SUPERIORITY||Slope|0.07||||0.78|TWO_SIDED|95.0|-0.41|0.54|||Chi-squared|||Q15 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.54|-0.41|0.78
71945665|NCT05247229|143414997|SUPERIORITY||Slope|0.51||||0.01|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||Q1 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.86|0.16|0.01
71945666|NCT05247229|143414997|SUPERIORITY||Slope|0.09||||0.67|TWO_SIDED|95.0|-0.34|0.52|||Chi-squared|||Q2 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.34|0.67
71945667|NCT05247229|143414997|SUPERIORITY||Slope|0.13||||0.35|TWO_SIDED|95.0|-0.15|0.41|||Chi-squared|||Q3 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.41|-0.15|0.35
71945668|NCT05247229|143414997|SUPERIORITY||Slope|0.09||||0.73|TWO_SIDED|95.0|-0.43|0.61|||Chi-squared|||Q4 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.61|-0.43|0.73
71945669|NCT05247229|143414997|SUPERIORITY||Slope|0.2||||0.23|TWO_SIDED|95.0|-0.13|0.52|||Chi-squared|||Q5 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.52|-0.13|0.23
71945670|NCT05247229|143414997|SUPERIORITY||Slope|0.71||||0|TWO_SIDED|95.0|0.27|1.15|||Chi-squared|||Q9 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||1.15|0.27|0.00
71945671|NCT05247229|143414997|SUPERIORITY||Slope|0.37||||0.05|TWO_SIDED|95.0|0.0|0.73|||Chi-squared|||Q10 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.73|0.00|0.05
71945672|NCT05247229|143414997|SUPERIORITY||Slope|0.37||||0.1|TWO_SIDED|95.0|-0.07|0.82|||Chi-squared|||Q11 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.82|-0.07|0.10
71945673|NCT05247229|143414997|SUPERIORITY||Slope|0.3||||0.32|TWO_SIDED|95.0|-0.3|0.91|||Chi-squared|||Q12 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.91|-0.30|0.32
71945674|NCT05247229|143414997|SUPERIORITY||Slope|0.22||||0.36|TWO_SIDED|95.0|-0.25|0.7|||Chi-squared|||Q13 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.70|-0.25|0.36
71945675|NCT05247229|143414997|SUPERIORITY||Slope|0.35||||0.11|TWO_SIDED|95.0|-0.07|0.78|||Chi-squared|||Q14 Difference between pre- and post-program surveys from generalized estimating equation linear regressions accounting for clustering of longitudinal observations within person, adjusted associations and 95% confidence intervals.||0.78|-0.07|0.11
71945676|NCT02472795|143415003|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.39|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||||0.22|-0.56|0.39
71945677|NCT02472795|143415003|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED|95.0|-0.91|0.09|||ANCOVA|||||0.09|-0.91|0.02
71945678|NCT02472795|143415003|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.95|-0.19|||ANCOVA|||||-0.19|-0.95|0.004
71945679|NCT02472795|143415003|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.19||0.06|TWO_SIDED|95.0|-0.75|0.02|||ANCOVA|||||0.02|-0.75|0.06
71945680|NCT02472795|143415005|SUPERIORITY||Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.134||0.2837|TWO_SIDED|95.0|-0.413|0.123|||ANCOVA|||||0.123|-0.413|0.2837
71945681|NCT02472795|143415005|SUPERIORITY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.797|-0.234|||ANCOVA|||||-0.234|-0.797|0.0006
71945682|NCT02472795|143415005|SUPERIORITY||Mean Difference (Final Values)|-0.565|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.825|-0.305|||ANCOVA|||||-0.305|-0.825|0.0001
71945683|NCT02472795|143415005|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-1.173|-0.586|||ANCOVA|||||-0.586|-1.173|<0.0001
71945684|NCT02472795|143415007|SUPERIORITY||Mean Difference (Final Values)|-13.214|STANDARD_ERROR_OF_MEAN|9.626||0.1755|TWO_SIDED|95.0|-32.513|6.085|||ANCOVA|||||6.085|-32.513|0.1755
71945685|NCT02472795|143415007|SUPERIORITY||Mean Difference (Final Values)|-39.311|STANDARD_ERROR_OF_MEAN|10.096||0.0003|TWO_SIDED|95.0|-59.552|-19.069|||ANCOVA|||||-19.069|-59.552|0.0003
71945686|NCT02472795|143415007|SUPERIORITY||Mean Difference (Final Values)|-47.278|STANDARD_ERROR_OF_MEAN|9.329|<|0.0001|TWO_SIDED|95.0|-65.981|-28.574|||ANCOVA|||||-28.574|-65.981|<0.0001
71945687|NCT02472795|143415007|SUPERIORITY||Mean Difference (Final Values)|-56.452|STANDARD_ERROR_OF_MEAN|10.541|<|0.0001|TWO_SIDED|95.0|-77.585|-35.32|||ANCOVA|||||-35.320|-77.585|<0.0001
71945688|NCT01754597|143415011|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
71945689|NCT01754597|143415012|SUPERIORITY|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
71945690|NCT01754597|143415013|SUPERIORITY|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
71945691|NCT01588236|143415014|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0||||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|Mixed Models Analysis|||||||>0.05
71945692|NCT01588236|143415015|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo||||>0.05
71945693|NCT01588236|143415016|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between high dose vs placebo|Mixed Models Analysis|||||||<0.01
71945694|NCT01588236|143415017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||p value for comparison between overall drug group vs placebo, and between low dose vs placebo|Mixed Models Analysis|||||||<0.05
71945695|NCT02819141|143415021|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< 0.05.|Generalized estimating equations|Controlling for age, daily sequential organ failure assessment (SOFA) score, sedation intensity, and time of day of assessment||We estimated the power for multilevel models approximating our study design. A sample size of 95 patients per arm, 190 total (at a minimum 7 data collection points for each, resulting in \~1,050 observations) will have greater than 80% power to detect small to moderate effects (i.e., 0.11 or greater) in between-group differences in anxiety, delirium, and duration of mechanical ventilation at alpha = .05 for all proposed models.||||0.30
71945696|NCT02819141|143415021|SUPERIORITY|Controlling for time of day, study day, age, sex, illness severity, and sedation frequency||||||0.9858|||||||Generalized Estimating equations|||||||0.9858
71945697|NCT02819141|143415022|SUPERIORITY|||||||0.02||||||a priori threshold for significance p \< 0.05.|t-test, 1 sided|||||||0.02
71945698|NCT02819141|143415023|SUPERIORITY|||||||0.97|||||||Generalized estimating equations|Controlling for sedation intensity, age, daily Sequential Organ Failure Assessment (SOFA) score, study day, and time of day assessment||||||0.97
71945699|NCT02819141|143415023|SUPERIORITY|||||||0.5647|||||||Generalized estimating equations|Controlling for sedation frequency, age, sex, illness severity, study day, and time of day assessment.||||||0.5647
71945700|NCT02819141|143415024|SUPERIORITY|||||||0.39|||||||Generalized estimating equation|controlling for age, daily Sequential Organ Failure Assessment (SOFA) score, time of day of assessment||||||0.39
71945701|NCT02819141|143415025|SUPERIORITY|||||||0.37|||||||GEE|||||||0.37
71945702|NCT02819141|143415026|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
71945703|NCT02819141|143415026|SUPERIORITY|||||||0.81|||||||t-test, 1 sided|||||||0.81
71945704|NCT02819141|143415027|SUPERIORITY|||||||0.47|||||||t-test, 1 sided|||||||0.47
71945705|NCT02819141|143415027|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
71945706|NCT02819141|143415028|SUPERIORITY|||||||0.164|||||||t-test, 1 sided|||3 months after ICU discharge||||0.164
71945707|NCT02819141|143415028|SUPERIORITY|||||||0.84|||||||t-test, 1 sided|||6 months after ICU discharge||||0.84
71945708|NCT02819141|143415029|SUPERIORITY|||||||0.26|||||||t-test, 1 sided|||||||0.26
71945709|NCT02819141|143415030|SUPERIORITY|||||||0.82|||||||t-test, 1 sided|||||||0.82
71945710|NCT02819141|143415031|SUPERIORITY|||||||0.018|||||||t-test, 1 sided|||||||0.018
71945711|NCT02819141|143415032|SUPERIORITY|||||||0.66|||||||t-test, 1 sided|||||||0.66
71945712|NCT02819141|143415033|SUPERIORITY|||||||0.63|||||||t-test, 1 sided|||||||0.63
71945713|NCT02819141|143415034|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||||||0.41
71945714|NCT02819141|143415035|SUPERIORITY|||||||0.06|||||||t-test, 1 sided|||||||0.06
71945715|NCT02819141|143415036|SUPERIORITY|||||||0.93|||||||t-test, 1 sided|||||||0.93
71945716|NCT02819141|143415037|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.43
71945717|NCT02819141|143415038|SUPERIORITY|||||||0.69|||||||t-test, 1 sided|||||||0.69
71945718|NCT02819141|143415039|SUPERIORITY|||||||0.94|||||||t-test, 1 sided|||||||0.94
71945719|NCT02819141|143415040|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|||||||0.50
71945720|NCT02819141|143415041|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
71945721|NCT02819141|143415042|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
71945722|NCT02819141|143415043|SUPERIORITY|||||||0.85|||||||t-test, 1 sided|||||||0.85
71945723|NCT02819141|143415044|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
71945724|NCT00597012|143415086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4||||0.26|TWO_SIDED|95.0|-1.8|6.5|||ANCOVA|||"The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned."||6.5|-1.8|0.26
71945725|NCT00597012|143415087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9||||0.16|TWO_SIDED|95.0|-1.2|7.0|||ANCOVA|||||7.0|-1.2|0.16
71945726|NCT00597012|143415088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1||||0.68|TWO_SIDED|95.0|-4.4|6.6|||ANCOVA|||||6.6|-4.4|0.68
71701302|NCT00157755|142918812|SUPERIORITY_OR_OTHER|||||||0.215||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.215
71701303|NCT00157755|142918812|SUPERIORITY_OR_OTHER|||||||1||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||1.0
71701304|NCT00157755|142918813|SUPERIORITY_OR_OTHER|||||||0.903||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.903
71701305|NCT00157755|142918813|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"||||0.932
71886104|NCT05030311|143292908|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.635|<|0.001|TWO_SIDED|95.0|-4.85|-2.36|||Mixed Models Analysis||MMRM adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, visit week, baseline score and both interaction of treatment by visit week and interaction of baseline score by visit week.|HSS7 at Week 12 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)||-2.36|-4.85|<0.001
71886105|NCT05030311|143292909|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.001|TWO_SIDED|95.0|2.0|4.84|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Disease activity control (UAS7 =\< 6) at Week 12||4.84|2.00|<0.001
71886106|NCT05030311|143292910|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.16|6.82|||Regression, Logistic|Logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.||Complete absence of hives and itch (UAS7 = 0) at Week 12||6.82|2.16|<0.001
71886107|NCT05030311|143292911|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|6.18|39.77|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics, and baseline UAS7 score.|||39.77|6.18|<0.001
71886108|NCT05030311|143292912|SUPERIORITY||Rate ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.01|3.61|||Negative binomial regression model|Negative binomial regression model with log link, using treatment arm, geographical region, and prior exposure to anti-IgE biologics as covariates.||||3.61|2.01|<0.001
71886109|NCT05030311|143292913|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.53|3.9|||Regression, Logistic||Statistical model used logistic regression adjusting for treatment arm, geographical region, prior exposure to anti-IgE biologics and baseline DLQI score.|||3.90|1.53|<0.001
71886110|NCT05030311|143292914|SUPERIORITY||Rate ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.41|||Regression, Linear||Statistical model used a negative binomial regression with log link included treatment arm as fixed effect, geographical region, prior exposure to anti-IgE biologics, baseline AAS7 = 0 response as covariates.|Angioedema occurrence-free weeks (AAS7 = 0 response) up to Week 12||1.41|1.12|<0.001
71886111|NCT00608985|143292942|SUPERIORITY_OR_OTHER||Median Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-21.8|-8.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-8.8|-21.8|<0.0001
71886112|NCT00608985|143292942|SUPERIORITY_OR_OTHER||Median Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-34.3|-19.5|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-19.5|-34.3|<0.0001
71886113|NCT00608985|143292942|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.8||||0.0376|TWO_SIDED|95.0|-13.5|-0.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-0.3|-13.5|0.0376
71886114|NCT00608985|143292943|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.5||||0.0001|TWO_SIDED|95.0|-20.3|-6.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-6.5|-20.3|0.0001
71886115|NCT00608985|143292943|SUPERIORITY_OR_OTHER||Median Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-27.3|-12.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-12.3|-27.3|<0.0001
71886116|NCT00608985|143292943|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.5||||0.3358|TWO_SIDED|95.0|-3.8|11.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||11.0|-3.8|0.3358
71886117|NCT00608985|143292944|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.3||||0.0186|TWO_SIDED|95.0|-13.3|-1.3|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.3|-13.3|0.0186
71886118|NCT00608985|143292944|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.4||||0.0006|TWO_SIDED|95.0|-16.4|-4.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-4.6|-16.4|0.0006
71886119|NCT00608985|143292944|SUPERIORITY_OR_OTHER||Median Difference (Net)|-12.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-6.6|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-6.6|-18.8|<0.0001
71886120|NCT00608985|143292945|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.3||||0.0035|TWO_SIDED|95.0|-15.3|-3.0|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-3.0|-15.3|0.0035
71886121|NCT00608985|143292945|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.5||||0.0006|TWO_SIDED|95.0|-15.0|-4.3|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-4.3|-15.0|0.0006
71886122|NCT00608985|143292945|SUPERIORITY_OR_OTHER||Median Difference (Net)|-16.0|||<|0.0001|TWO_SIDED|95.0|-22.0|-9.8|||Wilcoxon rank-sum|||Change from baseline to day 1\&2 compared with placebo||-9.8|-22.0|<0.0001
71886123|NCT00608985|143292946|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.2237|TWO_SIDED|95.0|-11.0|2.5|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||2.5|-11.0|0.2237
71886124|NCT00608985|143292946|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.0||||0.0607|TWO_SIDED|95.0|-12.3|0.3|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||0.3|-12.3|0.0607
71886125|NCT00608985|143292946|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.5||||0.0017|TWO_SIDED|95.0|-17.3|-4.0|||Wilcoxon rank-sum|||Change from baseline to day 15\&16 compared with placebo||-4.0|-17.3|0.0017
71886126|NCT00608985|143292947|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.1||||0.1187|TWO_SIDED|95.0|-9.1|0.9|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||0.9|-9.1|0.1187
71886127|NCT00608985|143292947|SUPERIORITY_OR_OTHER||Median Difference (Net)|-7.1||||0.0017|TWO_SIDED|95.0|-11.5|-2.7|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-2.7|-11.5|0.0017
71886128|NCT00608985|143292947|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.1||||0.0121|TWO_SIDED|95.0|-10.8|-1.4|||Wilcoxon rank-sum|||Change from baseline to week 1\&2 compared with placebo||-1.4|-10.8|0.0121
71886129|NCT00662792|143292971|SUPERIORITY||Difference of adjusted means|0.13|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.102|0.158|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period.|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-12||0.158|0.102|<0.0001
71886130|NCT00662792|143292971|SUPERIORITY||Difference of adjusted means|0.07|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.042|0.097|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs Tiotropium (Tio18GEL) for FEV1 AUC0- 12||0.097|0.042|<.0001
71701306|NCT00157755|142918814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
71701307|NCT00157755|142918814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"||||<0.001
71701308|NCT00157755|142918815|SUPERIORITY_OR_OTHER|||||||0.014||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||0.014
71886131|NCT00662792|143292971|OTHER||Difference of adjusted means|-0.024|STANDARD_ERROR_OF_MEAN|0.014||0.0914|TWO_SIDED|95.0|-0.052|0.004|||ANOVA|Analysis of variance with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.004|-0.052|0.0914
71823328|NCT00495469|143149762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.363|TWO_SIDED|95.0|-0.59|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.22|-0.59|0.363
71701309|NCT00157755|142918815|SUPERIORITY_OR_OTHER||||||<|0.001||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"||||<0.001
71701310|NCT00157755|142918816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
71701311|NCT00157755|142918816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"||||<0.001
71701312|NCT00157755|142918817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||<0.001
71823329|NCT00495469|143149762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.111|TWO_SIDED|95.0|-0.76|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-0.76|0.111
71823330|NCT00495469|143149762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.08|TWO_SIDED|95.0|-0.77|0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.04|-0.77|0.080
71701313|NCT00157755|142918817|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"||||0.043
71886132|NCT00662792|143292972|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-Inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) for FEV1AUC12-24||0.093|0.036|<.0001
71886133|NCT00662792|143292972|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Difference of adjusted means|0.064|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.036|0.093|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of FEV1AUC12-24||0.093|0.036|<.0001
71886134|NCT00662792|143292972|OTHER||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.015||0.0001|TWO_SIDED|95.0|-0.086|-0.028|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.028|-0.086|0.0001
71886135|NCT00662792|143292973|SUPERIORITY||Difference of adjusted means|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.102|0.166|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of Peak FEV1||0.166|0.102|<.0001
71886136|NCT00662792|143292973|SUPERIORITY||Difference of adjusted means|0.066|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.034|0.098|||ANOVA|Analysis of with terms for centre, patient with centre, treatment, and period. α = 0.025 one-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of PeakFEV1.||0.098|0.034|<.0001
71886137|NCT00662792|143292973|OTHER||Difference of adjusted means|-0.026|STANDARD_ERROR_OF_MEAN|0.016||0.1093|TWO_SIDED|95.0|-0.058|0.006|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S\_DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||0.006|-0.058|0.1093
71701314|NCT00157755|142918818|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.009
71701315|NCT00157755|142918818|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"||||0.001
71701316|NCT00157755|142918819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
71701317|NCT00157755|142918819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||<0.001
71701318|NCT00157755|142918820|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.016
71886138|NCT00662792|143292974|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as d=0.050 L.|Differences of adjusted means|0.058|STANDARD_ERROR_OF_MEAN|0.017||0.0008|TWO_SIDED|95.0|0.024|0.092|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Salm50DPI)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Salmeterol (Salm50DPI) of trough FEV1||0.092|0.024|0.0008
71701319|NCT00157755|142918820|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"||||0.236
71701320|NCT05845619|142918838|SUPERIORITY|There was no power calculation because this was a pilot study.|Odds Ratio (OR)|1.21||||0.33|TWO_SIDED|95.0|0.83|1.76|||Regression, Logistic||Numerator: pilot; denominator: prospective controls|In this pilot study, we hypothesized that pilot participants would have a reduced risk of viremia 6 months after the intervention compared to controls.||1.76|0.83|0.33
71701321|NCT05845619|142918838|SUPERIORITY|No power calculation, pilot study.|Odds Ratio (OR)|1.25||||0.41|TWO_SIDED|95.0|0.73|2.14|||Regression, Logistic|||||2.14|0.73|0.41
71701322|NCT03785366|142918846|OTHER|"For the primary analysis, a ANOVA model with treatment as a fixed effect and subject as a random effect was used to analyze the uncorrected PK parameters Cmax, Cmean, and AUC0-56 days.~Analysis methodology for the secondary analysis mirrored the approach for the primary analysis applied to the baseline-corrected PK parameters."|test to Reference geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||||1.25|0.80|
71701323|NCT04153864|142918855|NON_INFERIORITY|The Non-Inferiority Margin (NIM) was defined as 10% of the mean EPDS score in the Specialist group (8.91), which corresponded to a value of 0.89. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.86|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 10% non-inferiority margin (NIM).||0.86||<0.05
71823331|NCT00495469|143149762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.267|TWO_SIDED|95.0|-0.64|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.18|-0.64|0.267
71701324|NCT04153864|142918855|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.92), which corresponded to a value of 1.16. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.23|||<|0.05|ONE_SIDED|95.0||0.77|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.77||<0.05
71660843|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
71660844|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.003
71660845|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.088
71660846|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.016||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.016
71660847|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.068
71660848|NCT03118570|142835395|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.16||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.160
71660849|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.065||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.065
71660850|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.405||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.405
71660851|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.966||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.966
71660852|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.003
71660853|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.229||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.229
71660854|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.807||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.807
71660855|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.042||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.042
71660856|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.283
71660857|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.536||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.536
71660858|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.765||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.765
71660859|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.247||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.247
71660860|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.050
71660861|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.037
71701325|NCT04153864|142918855|NON_INFERIORITY|The NIM was defined as 13% of the mean EPDS score in the In-Person group (8.81), which corresponded to a value of 1.15. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.36|||<|0.05|ONE_SIDED|95.0||0.91|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this is per protocol analysis. Due to institutional pandemic-related restrictions, 21 participants were switched from In-Person to Telemedicine and met criteria for the per protocol analyses.||0.91||<0.05
71701326|NCT04153864|142918857|NON_INFERIORITY|The NIM was defined as 10% of the mean GAD-7 score for the Specialist group (6.36), which corresponded to a value of 0.64. This predetermined NIM of 10% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.08|||<|0.05|ONE_SIDED|95.0||0.57|||t-test, 1 sided|||Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 10% non-inferiority margin (NIM).This analysis was performed on 3-months post-randomization scores.||0.57||<0.05
71701327|NCT04153864|142918857|NON_INFERIORITY|The NIM was defined as 13% of the mean GAD-7 score in the In-Person group (6.29), which corresponded to a value of 0.82. This predetermined NIM of 13% aligns with noninferiority guidelines and ensures clinically meaningful conclusions.|Mean Difference (Final Values)|0.14|||<|0.05|ONE_SIDED|95.0||0.73|||t-test, 1 sided|||Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.||0.73||<0.05
71701328|NCT01348269|142918859|OTHER|T-test (with MITT, omitting outlier value of one patient in placebo group)|||||=|0.006|||||||t-test, 2 sided|||||||=0.006
71701329|NCT01348269|142918859|OTHER|Mann-Whitney-Test|||||=|0.015|||||||Wilcoxon (Mann-Whitney)|||||||=0.015
71701330|NCT02452190|142918906|SUPERIORITY|A fixed-sequence multiple testing procedure was implemented to test the primary and secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.|CAE rate ratio (reslizumab vs placebo)|0.79||||0.194|TWO_SIDED|95.0|0.562|1.124||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group, randomization stratification factors, and number of prior exacerbations as model factors and the logarithm of treatment duration excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.124|0.562|0.194
71701331|NCT03112603|142918942|OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|1.86|4.8|||Cochran-Mantel-Haenszel|||||4.80|1.86|<0.0001
71701332|NCT03112603|142918944|OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.268|0.51||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.510|0.268|<0.0001
71701333|NCT03112603|142918945|OTHER||Hazard Ratio (HR)|0.361|||||TWO_SIDED|95.0|0.268|0.485|||||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||0.485|0.268|
71701334|NCT03112603|142918946|OTHER||Odds Ratio (OR)|2.17||||0.0011|TWO_SIDED|95.0|1.34|3.52||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel||The odds ratio and 95% confidence interval (CI) were calculated using a stratified Cochran-Mantel-Haenszel test.|||3.52|1.34|0.0011
71701335|NCT03112603|142918948|OTHER||Odds Ratio (OR)|2.77|||<|0.0001|TWO_SIDED|95.0|1.75|4.39||The one-sided p-value was calculated using a stratified Cochran-Mantel-Haenszel (CMH) test.|Cochran-Mantel-Haenszel||The odds ratio and 95% CI were calculated using a stratified CMH test.|||4.39|1.75|<0.0001
71701336|NCT03112603|142918950|OTHER||Hazard Ratio (HR)|0.851||||0.2396|TWO_SIDED|95.0|0.544|1.331||The p-value was derived from a 1-sided stratified log-rank test.|Log Rank||The hazard ratio was obtained from a stratified Cox model using cGvHD severity at randomization as strata.|||1.331|0.544|0.2396
71701337|NCT02320175|142918995|OTHER|We compared percent top-box experience ratings pre- vs. post-intervention using a GEE chi-squared test for binary outcomes, clustered by site. Top-box score was calculated as the percentage of participants that gave the top-most response for the given survey item (e.g., 5=Extremely; 5=Excellent). Missing data was accounted for through use of multiple imputations appropriate for missing data in clustered studies.|||||<|0.05|||||||GEE chi-squared test for binary outcomes|||||||<.05
71701338|NCT00876343|142919001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.006|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|||||-0.6|-3.7|0.006
71701339|NCT00876343|142919001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.5|||ANCOVA|||||-1.5|-4.6|<0.001
71701340|NCT01933932|142919026|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.4355|TWO_SIDED|95.0|0.77|1.12|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.12|0.77|0.4355
71701341|NCT01933932|142919027|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.6431|TWO_SIDED|95.0|0.85|1.3|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.30|0.85|0.6431
71701342|NCT01933932|142919028|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0515|TWO_SIDED|95.0|1.0|2.62|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||2.62|1.00|0.0515
71701343|NCT01933932|142919030|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5007|TWO_SIDED|95.0|0.74|1.86|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation||||1.86|0.74|0.5007
71701344|NCT01933932|142919031|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.3438|TWO_SIDED|95.0|0.74|1.11|||Log Rank|Analysis stratified by WHO performance status at randomisation.||||1.11|0.74|0.3438
71701345|NCT00230737|142919032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3594.0|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71701346|NCT04235374|142919116|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
71701347|NCT04235374|142919117|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
71701348|NCT04235374|142919118|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
71701349|NCT04235374|142919119|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
71701350|NCT04235374|142919120|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
71701351|NCT05495997|142919121|SUPERIORITY|||||||0.015|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.015
71886139|NCT00662792|143292974|NON_INFERIORITY|The non-inferiority margin for FEV1 endpoints was defined as a delta of 0.050 L.|Difference of adjusted means|0.029|STANDARD_ERROR_OF_MEAN|0.017||0.0857|TWO_SIDED|95.0|-0.004|0.063|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (Tio18GEL)|H1: Non-inferiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) of trough FEV1||0.063|-0.004|0.0857
71886140|NCT00662792|143292974|OTHER||Difference of adjusted means|-0.037|STANDARD_ERROR_OF_MEAN|0.017||0.0317|TWO_SIDED|95.0|-0.071|-0.003|||ANOVA|"Analysis of variance with terms for centre, patient with centre, treatment, and period.~α = 0.025 one-sided"|(T+S\_PE) - (T18GEL+S-DPI)|The Tiotropium free combination (T18GEL+S\_DPI) was included in order to characterise this treatment in comparison with the FDC Tiotropium/Salmeterol (T+S\_PE). No formal hypotheses were defined.||-0.003|-0.071|0.0317
71886141|NCT00662792|143292975|SUPERIORITY||Difference of adjusted means|0.097|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.071|0.124|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Salm50DPI)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. salmeterol (Salm50DPI) for FEV1 AUC0-24||0.124|0.071|<.0001
71886142|NCT00662792|143292975|SUPERIORITY||Difference of adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.041|0.093|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|H1: Superiority of FDC Tiotropium/Salmeterol (T+S\_PE) vs. Tiotropium (TIO18GEL) for FEV1 AUC24||0.093|0.041|<.0001
71660862|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.174||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.174
71660863|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.558||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.558
71701352|NCT05495997|142919122|SUPERIORITY|||||||0.993|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.993
71701353|NCT05495997|142919123|SUPERIORITY|||||||0.517|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 6 weeks compared to baseline (group-by-time interaction)||||0.517
71701354|NCT05495997|142919124|SUPERIORITY|||||||0.817|||||||ANCOVA|||Mental Imagery Group (PD-MI) compared to Psychoeducation Control Group (PD-Con) at 18 weeks compared to baseline (group-by-time interaction)||||0.817
71660864|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.02||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.020
71660865|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.346||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.346
71701355|NCT00088153|142919125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||After controlling for baseline age and weight changes|t-test, 2 sided|We also used a mixed model analysis of variance (PROC MIXED), to analyze longitudinal data.||Power analysis: We have previously demonstrated that normal female adolescents gain bone density at the rate of 0.039 +/- 0.0507 per year. The pooled SD in that study was 0.046. Based on these data, with a sample size of 110 girls with anorexia nervosa (AN), half of whom are randomized to receive estrogen and half placebo (with a 10% drop-out rate), there will be an 80% chance that we will detect an increase in bone density to 75% of normal in the girls who receive estrogen.||||<0.05
71701356|NCT00088153|142919126|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there would be no differences between the groups for changes in P1NP levels over time||||>0.05
71701357|NCT00088153|142919127|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||The p value was adjusted for age and weight changes|t-test, 2 sided|||The null hypothesis was that the groups would not differ for changes in spine bone density z-scores over the study duration||||<0.05
71701358|NCT04357795|142919161|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71701359|NCT04357795|142919162|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71701360|NCT04357795|142919163|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71701361|NCT04357795|142919164|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71701362|NCT04357795|142919165|OTHER|Single group analysis||||||0.0323|||||||Paired t-test|OD- Right eye p value||||||0.0323
71701363|NCT04357795|142919165|OTHER|Single group analysis||||||0.3447||||||OS: P-Value|Paired t-test|||||||0.3447
71886143|NCT00662792|143292975|SUPERIORITY||Difference of adjusted means|-0.041|STANDARD_ERROR_OF_MEAN|0.014||0.0029|TWO_SIDED|95.0|-0.067|-0.014|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (T18GEL+S-DPI)|||-0.014|-0.067|0.0029
71886144|NCT00662792|143292976|SUPERIORITY||Difference of adjusted means|0.083|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|0.034|0.132|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided|(T+S\_PE) - (Tio18GEL)|||0.132|0.034|0.0010
71886145|NCT00662792|143292976|SUPERIORITY||Difference of adjusted means|0.176|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.127|0.226|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.226|0.127|<.0001
71701364|NCT04357795|142919166|OTHER|Single group analysis|||||<|0.0001|||||||Paired t-test|||||||<0.0001
71701365|NCT04357795|142919167|OTHER|Single group analysis||||||0.0029|||||||Paired t-test|||||||0.0029
71660866|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.387||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.387
71701366|NCT05168800|142919169|SUPERIORITY|||||||0.99||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.99
71701367|NCT05168800|142919169|SUPERIORITY|||||||0.98||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or greater than 2.15 standard deviations of the mean for the superiority analyses.|Groupwise binomial comparison|||||||0.98
71823332|NCT00495469|143149762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.549|TWO_SIDED|95.0|-0.54|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.29|-0.54|0.549
71823333|NCT00495469|143149762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.056|TWO_SIDED|95.0|-0.81|0.01||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.01|-0.81|0.056
71886146|NCT00662792|143292976|SUPERIORITY||Difference of adjusted means|-0.045|STANDARD_ERROR_OF_MEAN|0.025||0.0757|TWO_SIDED|95.0|-0.095|0.005|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.005|-0.095|0.0757
71886147|NCT00662792|143292977|SUPERIORITY||Difference of adjusted means|0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.033|0.137|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.137|0.033|0.0015
71701368|NCT05168800|142919169|EQUIVALENCE|A sample size of 1800 LTCWs (600 per arm) was identified to provide 80% power to detect an 8% difference in the rate of individuals reporting vaccine confidence between arms with 95% confidence. This sample size was sufficient to retain 80% power to detect a 10% difference after 40% attrition. Per study design, the equivalence margin is +/- 10% with anticipated attrition using the binomial confidence interval.||||||0.85||||||To achieve a group-wise 95% confidence for the primary outcome, each of the three tests were evaluated with acceptance based on a 98.4% confidence interval, or +/- 2.45 standard deviations of the mean for the equivalency test.|Groupwise binomial comparison|||||||0.85
71701369|NCT05168800|142919170|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
71701370|NCT05168800|142919170|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.90
71701371|NCT05168800|142919170|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Fisher Exact|||||||0.83
71701372|NCT05168800|142919171|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
71701373|NCT05168800|142919171|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
71701374|NCT05168800|142919171|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.61|||||||Fisher Exact|||||||0.61
71701375|NCT05168800|142919172|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
71701376|NCT05168800|142919172|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71701377|NCT05168800|142919172|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Fisher Exact|||||||0.48
71886148|NCT00662792|143292977|SUPERIORITY||Difference of adjusted means|0.118|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.066|0.171|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.171|0.066|<.0001
71701378|NCT05168800|142919173|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
71701379|NCT05168800|142919173|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
71701380|NCT05168800|142919173|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.48|||||||Adjusted Wald test|||||||0.48
71701381|NCT05168800|142919174|SUPERIORITY|||||||0.95|||||||Adjusted Wald test|||||||0.95
71701382|NCT05168800|142919174|SUPERIORITY|||||||0.98|||||||Adjusted Wald test|||||||0.98
71701383|NCT05168800|142919174|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.66|||||||Adjusted Wald test|||||||0.66
71701384|NCT05168800|142919175|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
71701385|NCT05168800|142919175|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
71701386|NCT05168800|142919175|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.09|||||||Fisher Exact|||||||0.09
71701387|NCT05168800|142919176|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
71701388|NCT05168800|142919176|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
71701389|NCT05168800|142919176|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.1|||||||Fisher Exact|||||||0.10
71701390|NCT05168800|142919177|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
71701391|NCT05168800|142919177|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
71701392|NCT05168800|142919177|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.88|||||||Fisher Exact|||||||0.88
71701393|NCT05168800|142919178|SUPERIORITY|||||||0.92|||||||Adjusted Wald test|||||||0.92
71701394|NCT05168800|142919178|SUPERIORITY|||||||0.97|||||||Adjusted Wald test|||||||0.97
71701395|NCT05168800|142919178|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.83|||||||Adjusted Wald test|||||||0.83
71701396|NCT05168800|142919179|SUPERIORITY|||||||0.88|||||||Adjusted Wald test|||||||0.88
71701397|NCT05168800|142919179|SUPERIORITY|||||||0.49|||||||Adjusted Wald test|||||||0.49
71701398|NCT05168800|142919179|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.23|||||||Adjusted Wald test|||||||0.23
71701399|NCT05168800|142919180|SUPERIORITY|||||||0.9|||||||Adjusted Wald test|||||||0.90
71701400|NCT05168800|142919180|SUPERIORITY|||||||0.94|||||||Adjusted Wald test|||||||0.94
71701401|NCT05168800|142919180|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.86|||||||Adjusted Wald test|||||||0.86
71701402|NCT05168800|142919181|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
71701403|NCT05168800|142919181|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.0
71701404|NCT05168800|142919181|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.49|||||||Two-sample z test|||||||0.49
71701405|NCT05168800|142919182|SUPERIORITY|||||||0.88|||||||Two-sample z test|||||||0.88
71701406|NCT05168800|142919182|SUPERIORITY|||||||1|||||||Two-sample z test|||||||1.00
71701407|NCT05168800|142919182|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.02|||||||Two-sample z test|||||||0.02
71701408|NCT05168800|142919183|SUPERIORITY|||||||0.82|||||||Two-sample z test|||||||0.82
71701409|NCT05168800|142919183|SUPERIORITY|||||||0.97|||||||Two-sample z test|||||||0.97
71701410|NCT05168800|142919183|EQUIVALENCE|The study was not powered for secondary outcome analyses.||||||0.18|||||||Two-sample z test|||||||0.18
71701411|NCT00569127|142919211|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.55|TWO_SIDED|95.0|0.73|1.18||Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.|Regression, Cox||The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.|According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.||1.18|0.73|0.55
71701412|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|1.31|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
71701413|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|1.19|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
71701414|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
71886149|NCT00662792|143292977|SUPERIORITY||Difference of adjusted means|-0.085|STANDARD_ERROR_OF_MEAN|0.027||0.0017|TWO_SIDED|95.0|-0.138|-0.032|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.032|-0.138|0.0017
71701415|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|1.15|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
71701416|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|1.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
71701417|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
71701418|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
71701419|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
71701420|NCT06442800|142919216|SUPERIORITY||Mean Difference (Final Values)|0.58|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
71701421|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
71701422|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
71660867|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.093||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.093
71660868|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.156||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.156
71701423|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.54|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
71660869|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
71660870|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.92||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.920
71660871|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.040
71660872|NCT03118570|142835396|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.643||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.643
71701424|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
71701425|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.66|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
71701426|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
71701427|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
71701428|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||<0.001
71701429|NCT06442800|142919217|SUPERIORITY||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
71701430|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.38|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Multiple cancers vs. Control||||<0.001
71701431|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.34|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Dementia vs. Control||||<0.001
71701432|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.4|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Colorectal cancer vs. Control||||<0.001
71701433|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver cancer vs. Control||||<0.001
71701434|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.37|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Throat and mouth cancer vs. Control||||<0.001
71701435|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.11|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Liver disease vs. Control||||<0.001
71660873|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.285||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.285
71660874|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.544||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.544
71701436|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.25|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Hypertension vs. Control||||<0.001
71660875|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
71701437|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.04||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Current warning vs. Control||||0.02
71701438|NCT06442800|142919218|SUPERIORITY||Difference in predicted proportions|0.14|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Guidelines vs. Control||||<0.001
71761953|NCT01396447|143025845|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.3|-1.6||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|||-1.6|-6.3|0.0010
71823334|NCT00495469|143149763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.396|TWO_SIDED|95.0|-1.65|0.66||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.66|-1.65|0.396
71823335|NCT00495469|143149763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.013|TWO_SIDED|95.0|-2.7|-0.33||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.33|-2.70|0.013
71660876|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.179||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.179
71660877|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.513||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.513
71701439|NCT02629159|142919227|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|34.1|||<|0.001|TWO_SIDED|95.0|29.0|39.2||This comparison was the primary analysis for US/FDA regulatory purposes, and a ranked key secondary endpoint for EU/EMA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||39.2|29.0|<0.001
71701440|NCT02629159|142919227|SUPERIORITY||Response Rate Difference|7.5||||0.018|TWO_SIDED|95.0|1.2|13.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||13.8|1.2|0.018
71701441|NCT02629159|142919228|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|18.6|26.5||This comparison was the primary analysis for EU/EMA regulatory purposes, and a ranked key secondary endpoint for US/FDA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||26.5|18.6|<0.001
71701442|NCT02629159|142919228|SUPERIORITY||Response Rate Difference|10.7|||<|0.001|TWO_SIDED|95.0|5.3|16.1||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.1|5.3|<0.001
71701443|NCT02629159|142919229|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-1.33|||<|0.001|TWO_SIDED|95.0|-1.469|-1.194||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use, and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.194|-1.469|<0.001
71701444|NCT02629159|142919229|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.638|-0.295||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.295|-0.638|<0.001
71701445|NCT02629159|142919230|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.97|-0.37||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.37|-0.97|<0.001
71701446|NCT02629159|142919230|SUPERIORITY||LS Mean Difference|0.14||||0.448|TWO_SIDED|95.0|-0.23|0.51||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||0.51|-0.23|0.448
71701447|NCT02629159|142919231|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.372|-0.253||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.253|-0.372|<0.001
71701448|NCT02629159|142919231|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.184|-0.036||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab|||-0.036|-0.184|0.004
71701449|NCT02629159|142919232|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Response Rate Difference|16.1|||||TWO_SIDED|95.0|9.9|22.3|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.3|9.9|
71701450|NCT02629159|142919232|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|||||<|0.001||||||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.||||||<0.001
71701451|NCT02629159|142919232|SUPERIORITY||Response Rate Difference|30.3|||<|0.001|TWO_SIDED|95.0|25.6|35.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.0|25.6|<0.001
71701452|NCT02629159|142919233|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|3.52|5.15||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|3.52|<0.001
71823336|NCT00495469|143149763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44||||0.017|TWO_SIDED|95.0|-2.61|-0.26||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.26|-2.61|0.017
71823337|NCT00495469|143149763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.015|TWO_SIDED|95.0|-2.61|-0.28||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||-0.28|-2.61|0.015
71701453|NCT02629159|142919233|SUPERIORITY||LS Mean Difference|1.62||||0.002|TWO_SIDED|95.0|0.62|2.62||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.62|0.62|0.002
71761954|NCT01396447|143025845|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0374|TWO_SIDED|95.0|-4.9|-0.1||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|||-0.1|-4.9|0.0374
71823338|NCT00495469|143149763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.069|TWO_SIDED|95.0|-2.26|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||0.08|-2.26|0.069
71701454|NCT02629159|142919234|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|26.5|35.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||35.8|26.5|<0.001
71701455|NCT02629159|142919234|NON_INFERIORITY|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Response Rate Difference|16.3|||||TWO_SIDED|95.0|10.0|22.5|||||Response Rate Difference = Upadacitinib - Adalimumab|||22.5|10.0|
71701456|NCT02629159|142919234|SUPERIORITY||||||<|0.001||||||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use||||||<0.001
71701457|NCT02629159|142919235|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|24.1|||<|0.001|TWO_SIDED|95.0|19.4|28.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Placebo|||28.8|19.4|<0.001
71823339|NCT00495469|143149763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.086|TWO_SIDED|95.0|-0.15|2.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment||||2.20|-0.15|0.086
71823340|NCT00180674|143149785|SUPERIORITY|||||||0.043|||||||Wilcoxon Signed Ranks test|||||||0.043
71701458|NCT02629159|142919235|SUPERIORITY||Response Rate Difference|10.4||||0.001|TWO_SIDED|95.0|4.2|16.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.7|4.2|0.001
71701459|NCT02629159|142919236|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-44.04|||<|0.001|TWO_SIDED|95.0|-55.39|-32.69||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-32.69|-55.39|<0.001
71701460|NCT02629159|142919236|SUPERIORITY||LS Mean Difference|-9.92||||0.164|TWO_SIDED|95.0|-23.89|4.05||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||4.05|-23.89|0.164
71701461|NCT02629159|142919237|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.15|||<|0.001|TWO_SIDED|95.0|3.13|5.16||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate|Treatment Difference = Upadacitinib - Placebo|||5.16|3.13|<0.001
71701462|NCT02629159|142919237|SUPERIORITY||LS Mean Difference|1.51||||0.017|TWO_SIDED|95.0|0.27|2.76||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||2.76|0.27|0.017
71701463|NCT02629159|142919238|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.63|-3.27||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-3.27|-9.63|<0.001
71701464|NCT02629159|142919238|SUPERIORITY||LS Mean Difference|-16.3|||<|0.001|TWO_SIDED|95.0|-18.89|-13.71||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-13.71|-18.89|<0.001
71761955|NCT01396447|143025846|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.3025|TWO_SIDED|95.0|-0.4|0.1|||Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||0.1|-0.4|0.3025
71823341|NCT01106976|143149787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0012||||0.0009|TWO_SIDED||||||t-test, 1 sided|||Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.||||0.0009
71701465|NCT02629159|142919239|SUPERIORITY|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|7.5|||<|0.001|TWO_SIDED|95.0|3.0|12.1||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||12.1|3.0|<0.001
71701466|NCT02629159|142919239|SUPERIORITY||Response Rate Difference|-3.4||||0.187|TWO_SIDED|95.0|-8.2|1.5||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Adalimumab|||1.5|-8.2|0.187
71701467|NCT02629159|142919240|SUPERIORITY||Response Rate Difference|20.0|||<|0.001|TWO_SIDED|95.0|16.3|23.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo|||23.7|16.3|<0.001
71823342|NCT01823341|143149810|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71823343|NCT01823341|143149811|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71823344|NCT01823341|143149811|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71660878|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.849||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.849
71823345|NCT01823341|143149812|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71701468|NCT02629159|142919240|SUPERIORITY||Response Rate Difference|11.4|||<|0.001|TWO_SIDED|95.0|6.5|16.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab|||16.4|6.5|<0.001
71701469|NCT03033355|142919266|OTHER|||||||0.0012||||||Threshold for statistical significance used P-value \<0.05|Student t-Test|||Right Cingulate Body||||0.0012
71701470|NCT03033355|142919266|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Posterior Cingulate||||0.02
71701471|NCT03033355|142919266|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Anterior Cingulate||||0.0015
71701472|NCT03033355|142919266|OTHER|||||||0.0015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Prefrontal Cortex||||0.0015
71701473|NCT03033355|142919266|OTHER|||||||0.0138||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Insula||||0.0138
71701474|NCT03033355|142919266|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Pons Micturition Center||||0.049
71701475|NCT03033355|142919266|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Cerebellum||||0.001
71701476|NCT03033355|142919266|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Lentiform Nucleus||||0.026
71701477|NCT03033355|142919266|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Right Lentiform Nucleus||||0.026
71701478|NCT03033355|142919266|OTHER|||||||0.015||||||Threshold for statistical significance used P-value \<0.05|student t-test|||Left Amygdala/parahippocampal Gyrus||||0.015
71701479|NCT04717557|142919273|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71701480|NCT04717557|142919273|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701481|NCT04717557|142919274|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701482|NCT04717557|142919275|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701483|NCT04717557|142919276|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|t-test, 2 sided|||||||>0.5
71701484|NCT04717557|142919277|SUPERIORITY||||||>|0.5|||||||Cochran-Mantel-Haenszel|||Underpowered - no statistically significant difference.||||>0.5
71701485|NCT04717557|142919278|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701486|NCT04717557|142919279|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701487|NCT04717557|142919280|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701488|NCT04717557|142919281|SUPERIORITY||||||>|0.5||||||Underpowered due to early termination.|Chi-squared, Corrected|||||||>0.5
71701489|NCT02685735|142919346|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.882||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastophizing-optimism construct.||||0.882
71701490|NCT02685735|142919352|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without gabapentin treatment group. A statistically significant result is interpreted as evidence to support that the gabapentin treatment impacts some element of change after surgery (i.e, intercept or slope).||||||0.137||||||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the gabapentin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, age, sex, pupil diameter, and catastrophizing-optimism construct.||||0.137
71823346|NCT01823341|143149812|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
71701491|NCT02685735|142919353|SUPERIORITY||||||<|0.0001|||||||Chi-squared|14 degrees of freedom||The null hypothesis (H0) is that modeled trajectory of change in pain intensity report after total hip or total knee arthroplasty does not differ between oral gabapentin and placebo in a manner dependent on its interaction with preferred cognitive style and pre-surgery pupil resting diameter . The alternative hypothesis (H1) is that there is a difference between the two groups which is dependent on these interactions.|A likelihood ratio test was conducted to compare these two models, conditional on the difference in the degrees of freedom in both models. A statistically significant likelihood ratio test would be interpreted as evidence that the three mechanistic predictors (Catastrophising-Optimism construct, Study Group, resting Pupil diameter) impact some aspect of the change in pain that occurs after surgery. If a statistically significant effect is observed, the individual interaction parameters will be interpreted.|||<0.0001
71701492|NCT05965427|142919354|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
71701493|NCT05965427|142919355|SUPERIORITY|||||||0.005|||||||Chi-squared|||"Statistical analysis of Any of the specified clinical complications measure"||||0.005
71701494|NCT05965427|142919356|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
71701495|NCT05965427|142919358|SUPERIORITY|||||||0.002|||||||Chi-squared|||"Statistical analysis relates to not presenting with skin lesions measure"||||0.002
71701496|NCT05965427|142919362|SUPERIORITY|||||||0.114|||||||Chi-squared|||"Statistical analysis relates to any drug treatment for mpox measure"||||0.114
71701497|NCT05965427|142919363|SUPERIORITY||||||<|0.001|||||||Chi-squared|||"Statistical analysis relates to any drug for complications measure"||||<0.001
71701498|NCT05965427|142919364|SUPERIORITY|"Statistical analysis relates to lesion onset measure"|||||<|0.001|||||||Chi-squared|||||||<0.001
71701499|NCT02101788|142919378|SUPERIORITY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.28|1.07|||||Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.|||1.07|0.28|
71701500|NCT02101788|142919378|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.39|1.03|||||Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.|||1.03|0.39|
71701501|NCT02101788|142919378|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0929|TWO_SIDED|95.0|0.34|1.08|||Chi-squared||Estimation of mutation effect; mutant vs. wild-type in the SOC group.|Prognostic effect of the mutation status among patients in the SOC arm.||1.08|0.34|0.0929
71701502|NCT02101788|142919378|SUPERIORITY|||||||0.7195|||||||Chi-squared|||Predictive effect biomarker p-value||||0.7195
71701503|NCT00927472|142919385|SUPERIORITY_OR_OTHER|||||||0.0386|||||||t-test, 2 sided|||||||0.0386
71701504|NCT00927472|142919386|SUPERIORITY_OR_OTHER|||||||0.3675|||||||t-test, 2 sided|||||||0.3675
71701505|NCT00927472|142919387|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.0490
71701506|NCT00927472|142919388|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71701507|NCT00927472|142919389|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71701508|NCT00927472|142919390|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
71701509|NCT00927472|142919391|SUPERIORITY_OR_OTHER|||||||0.3817|||||||t-test, 2 sided|||||||0.3817
71701510|NCT00927472|142919392|SUPERIORITY_OR_OTHER|||||||0.1059|||||||t-test, 2 sided|||||||0.1059
71701511|NCT00927472|142919393|SUPERIORITY_OR_OTHER|||||||0.1088|||||||t-test, 2 sided|||||||0.1088
71701512|NCT00927472|142919394|SUPERIORITY_OR_OTHER|||||||0.1527|||||||t-test, 2 sided|||||||0.1527
71701513|NCT04556097|142919395|SUPERIORITY||Rate Ratio|0.61|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|0.31|1.2|||Difference in differences|Difference in differences model with a negative binomial distribution and log link that provides rate ratio estimate of the relative difference.|The rate ratio is estimated for intervention patients as compared to controls.|||1.20|0.31|0.05
71701514|NCT04556097|142919396|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.95||0.05|TWO_SIDED|95.0|-6.53|1.12|||Difference in differences|Difference in differences model with a Gaussian distribution and identity link that provides linear estimate of the relative point difference.||||1.12|-6.53|0.05
71701515|NCT02516241|142919399|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0751|TWO_SIDED|98.66|0.688|1.063||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.063|0.688|0.0751
71701516|NCT02516241|142919400|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.3039|TWO_SIDED|96.99|0.695|1.139||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.139|0.695|0.3039
71701517|NCT02516241|142919401|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8637|TWO_SIDED|95.0|0.83|1.169||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.169|0.830|0.8637
71701518|NCT02516241|142919402|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0091|TWO_SIDED|95.0|0.589|0.928||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.928|0.589|0.0091
71701519|NCT02516241|142919403|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7599|TWO_SIDED|95.0|0.799|1.359||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.359|0.799|0.7599
71701520|NCT02516241|142919403|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4424|TWO_SIDED|95.0|0.692|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.175|0.692|0.4424
71701521|NCT02516241|142919407|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.2579|TWO_SIDED|95.0|0.931|1.304||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.304|0.931|0.2579
71701522|NCT02516241|142919407|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0008|TWO_SIDED|95.0|1.124|1.567||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.567|1.124|0.0008
71701523|NCT02516241|142919408|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.2395|TWO_SIDED|95.0|0.705|1.091||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.091|0.705|0.2395
71701524|NCT02516241|142919408|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.2431|TWO_SIDED|95.0|0.917|1.406||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.406|0.917|0.2431
71701525|NCT02516241|142919409|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.0014|TWO_SIDED|95.0|1.177|1.99||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.990|1.177|0.0014
71701526|NCT02516241|142919409|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6236|TWO_SIDED|95.0|0.729|1.209||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.209|0.729|0.6236
71701527|NCT02516241|142919413|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0477|TWO_SIDED|95.0|0.683|0.998||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.998|0.683|0.0477
71701528|NCT02516241|142919413|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7885|TWO_SIDED|95.0|0.809|1.175||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.175|0.809|0.7885
71701529|NCT02516241|142919414|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0053|TWO_SIDED|95.0|0.549|0.901||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||0.901|0.549|0.0053
71701530|NCT02516241|142919414|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1336|TWO_SIDED|95.0|0.651|1.059||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.059|0.651|0.1336
71701531|NCT02516241|142919415|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8148|TWO_SIDED|95.0|0.772|1.391||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|||1.391|0.772|0.8148
71823347|NCT01823341|143149813|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71701532|NCT02516241|142919415|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.2684|TWO_SIDED|95.0|0.636|1.134||The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.|monotherapy as reference.||1.134|0.636|0.2684
71701533|NCT02516241|142919416|SUPERIORITY||Odds Ratio (OR)|0.58||||0.0005|TWO_SIDED|95.0|0.422|0.788||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.788|0.422|0.0005
71761956|NCT01396447|143025846|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0044|TWO_SIDED|95.0|-0.6|-0.2|||Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.2|-0.6|0.0044
71823348|NCT01823341|143149813|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
71823349|NCT01823341|143149814|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
71823350|NCT01823341|143149814|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
71823351|NCT01823341|143149815|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
71823352|NCT01823341|143149815|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||0.77
71701534|NCT02516241|142919416|SUPERIORITY||Odds Ratio (OR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.253|0.485||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.485|0.253|<0.0001
71701535|NCT02516241|142919417|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7708|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7708
71701536|NCT02516241|142919417|SUPERIORITY||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.268|0.61||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.610|0.268|<0.0001
71701537|NCT02516241|142919418|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.135|0.406||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.406|0.135|<0.0001
71701538|NCT02516241|142919418|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6195|TWO_SIDED|95.0|0.469|1.566||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.566|0.469|0.6195
71701539|NCT02516241|142919420|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0002|TWO_SIDED|95.0|0.41|0.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.759|0.410|0.0002
71701540|NCT02516241|142919420|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.267|0.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.500|0.267|<0.0001
71701541|NCT02516241|142919421|SUPERIORITY||Odds Ratio (OR)|0.87||||0.4959|TWO_SIDED|95.0|0.59|1.291||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.291|0.590|0.4959
71701542|NCT02516241|142919421|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.305|0.679||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.679|0.305|0.0001
71701543|NCT02516241|142919422|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.16|0.448||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.448|0.160|<0.0001
71701544|NCT02516241|142919422|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8074|TWO_SIDED|95.0|0.623|1.836||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.836|0.623|0.8074
71701545|NCT02516241|142919423|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0008|TWO_SIDED|95.0|0.432|0.802||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.802|0.432|0.0008
71701546|NCT02516241|142919423|SUPERIORITY||Odds Ratio (OR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.27|0.512||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|||0.512|0.270|<0.0001
71701547|NCT02516241|142919424|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7717|TWO_SIDED|95.0|0.639|1.394||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||1.394|0.639|0.7717
71701548|NCT02516241|142919424|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0001|TWO_SIDED|95.0|0.303|0.682||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.682|0.303|0.0001
71701549|NCT02516241|142919425|SUPERIORITY||Odds Ratio (OR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.151|0.439||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|||0.439|0.151|<0.0001
71701550|NCT02516241|142919425|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9692|TWO_SIDED|95.0|0.556|1.759||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status.|monotherapy as reference.||1.759|0.556|0.9692
71701551|NCT02516241|142919433|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.1617|TWO_SIDED|95.0|-0.6|3.59||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||3.59|-0.6|0.1617
71701552|NCT02516241|142919433|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0578|TWO_SIDED|95.0|-0.07|4.29||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.29|-0.07|0.0578
71701553|NCT02516241|142919433|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.2003|TWO_SIDED|95.0|-0.91|4.32||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||4.32|-0.91|0.2003
71701554|NCT02516241|142919433|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.0178|TWO_SIDED|95.0|0.57|6.0||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||6.00|0.57|0.0178
71701555|NCT02516241|142919433|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.3765|TWO_SIDED|95.0|-1.96|5.17||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||5.17|-1.96|0.3765
71886150|NCT00662792|143292978|SUPERIORITY||Difference of adjusted means|0.084|STANDARD_ERROR_OF_MEAN|0.024||0.0005|TWO_SIDED|95.0|0.037|0.131|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.131|0.037|0.0005
71701556|NCT02516241|142919433|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.03|TWO_SIDED|95.0|0.4|7.81||MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||7.81|0.40|0.0300
71701557|NCT02516241|142919434|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.1373|TWO_SIDED|95.0|-0.6|4.36||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||4.36|-0.6|0.1373
71701558|NCT02516241|142919434|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.0034|TWO_SIDED|95.0|1.26|6.27||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||6.27|1.26|0.0034
71701559|NCT02516241|142919434|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.1774|TWO_SIDED|95.0|-1.0|5.39||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||5.39|-1.00|0.1774
71701560|NCT02516241|142919434|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.0011|TWO_SIDED|95.0|2.19|8.65||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||8.65|2.19|0.0011
71701561|NCT02516241|142919434|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3494|TWO_SIDED|95.0|-2.27|6.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||6.38|-2.27|0.3494
71701562|NCT02516241|142919434|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.0011|TWO_SIDED|95.0|2.96|11.71||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||11.71|2.96|0.0011
71701563|NCT02516241|142919435|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.3865|TWO_SIDED|95.0|-4.35|1.69||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.69|-4.35|0.3865
71886151|NCT00662792|143292978|SUPERIORITY||Difference of adjusted means|0.147|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.194|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.194|0.100|<.0001
71701564|NCT02516241|142919435|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.284|TWO_SIDED|95.0|-5.05|1.49||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||NFBLSI- 18 score (Average overall visits)||1.49|-5.05|0.2840
71701565|NCT02516241|142919435|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.297|TWO_SIDED|95.0|-5.41|1.66||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.66|-5.41|0.2970
71701566|NCT02516241|142919435|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.3026|TWO_SIDED|95.0|-5.85|1.83||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL TOI (Average overall visits)||1.83|-5.85|0.3026
71701567|NCT02516241|142919435|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.3168|TWO_SIDED|95.0|-7.29|2.38||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||2.38|-7.29|0.3168
71701568|NCT02516241|142919435|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.2179|TWO_SIDED|95.0|-8.51|1.96||MMRM model included patient, treatment, cisplatin eligibility and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.|Mixed Models Analysis|||FACT-BL Total score (Average overall visits)||1.96|-8.51|0.2179
71701569|NCT02516241|142919436|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2419|TWO_SIDED|95.0|0.8|2.6||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patients with improvement in fatigue||2.6|0.8|0.2419
71701570|NCT02516241|142919436|SUPERIORITY||Odds Ratio (OR)|1.5||||0.1553|TWO_SIDED|95.0|0.9|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||2.8|0.9|0.1553
71701571|NCT02516241|142919436|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0003|TWO_SIDED|95.0|1.4|2.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.8|1.4|0.0003
71701572|NCT02516241|142919436|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0148|TWO_SIDED|95.0|1.1|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|1.1|0.0148
71701573|NCT02516241|142919437|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2473|TWO_SIDED|95.0|0.7|3.4||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.4|0.7|0.2473
71701574|NCT02516241|142919437|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0148|TWO_SIDED|95.0|0.8|3.8||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.8|0.8|0.0148
71701575|NCT02516241|142919437|SUPERIORITY||Odds Ratio (OR)|1.9||||0.009|TWO_SIDED|95.0|1.2|3.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||3.0|1.2|0.0090
71701576|NCT02516241|142919437|SUPERIORITY||Odds Ratio (OR)|1.4||||0.151|TWO_SIDED|95.0|0.9|2.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||2.3|0.9|0.1510
71701577|NCT02516241|142919438|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6763|TWO_SIDED|95.0|0.5|3.2||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.2|0.5|0.6763
71701578|NCT02516241|142919438|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6539|TWO_SIDED|95.0|0.5|3.3||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patients with improvement in fatigue||3.3|0.5|0.6539
71701579|NCT02516241|142919438|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0092|TWO_SIDED|95.0|1.2|4.0||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood|Patient with deterioration in pain||4.0|1.2|0.0092
71701580|NCT02516241|142919438|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0324|TWO_SIDED|95.0|1.1|3.5||P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for visceral metastases and cisplatin eligibility status.|Regression, Logistic||The OR and confidence interval (CI) were calculated using logistic regression, adjusting for visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.|Patient with deterioration in pain||3.5|1.1|0.0324
71701581|NCT04070703|142919444|SUPERIORITY|The co-primary outcome data were analyzed via a Group by Time mixed-effects model with repeated measures on the second factor (i.e., outcome measures assessed at baseline and 6 months. In the presence of a Group by Time interaction effect, pre-specified follow-up pair-wise comparisons were performed to determine between-group differences.|Mean Difference (Final Values)|2.8||||0.0125|TWO_SIDED|98.75|2.1|3.6|||Mixed Models Analysis|||||3.6|2.1|0.0125
71701582|NCT04070703|142919444|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.0125|TWO_SIDED|98.75|0.07|2.2|||Mixed Models Analysis|||||2.2|.07|.0125
71701583|NCT04070703|142919445|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0125|TWO_SIDED|98.75|2.8|16.6|||Mixed Models Analysis|||||16.6|2.8|.0125
71701584|NCT04070703|142919445|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.0125|TWO_SIDED|98.75|12.6|31.2|||Mixed Models Analysis|||||31.2|12.6|.0125
71701585|NCT04070703|142919446|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.05|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||||-.1|-.5|0.05
71701586|NCT04070703|142919446|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.05|TWO_SIDED|95.0|-0.7|-0.3|||Mixed Models Analysis|||||-.3|-.7|.05
71701587|NCT04070703|142919447|SUPERIORITY||Mean Difference (Final Values)|-14.1||||0.05|TWO_SIDED|95.0|-20.0|-8.0|||Mixed Models Analysis|||||-8|-20|.05
71701588|NCT04070703|142919447|SUPERIORITY||Mean Difference (Final Values)|-22.0||||0.05|TWO_SIDED|95.0|-28.0|-16.0|||Mixed Models Analysis|||||-16|-28|.05
71701589|NCT04070703|142919448|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||.1|-.4|<.05
71701590|NCT04070703|142919448|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|0.4|1.2|||Mixed Models Analysis|||||1.2|.4|<.05
71701591|NCT04070703|142919449|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|0.5|1.6|||Mixed Models Analysis|||||1.6|.5|<.05
71701592|NCT04070703|142919449|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.7|||Mixed Models Analysis|||||2.7|1.6|<.05
71701593|NCT04070703|142919450|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.05|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||||2.1|-.4|<.05
71701594|NCT04070703|142919450|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.05|TWO_SIDED|95.0|3.1|5.0|||Mixed Models Analysis|||||5|3.1|<.05
71701595|NCT04070703|142919451|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||.7|-.3|<.05
71701596|NCT04070703|142919451|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.05|TWO_SIDED|95.0|-2.4|-1.4|||Mixed Models Analysis|||||-1.4|-2.4|<.05
71701597|NCT04070703|142919452|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.05|TWO_SIDED|95.0|-1.4|0.4|||Mixed Models Analysis|||||.4|-1.4|<.05
71701598|NCT04070703|142919452|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.05|TWO_SIDED|95.0|0.8|2.3|||Mixed Models Analysis|||||2.3|.8|<.05
71701599|NCT04070703|142919453|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||||1.1|-.1|<.05
71701600|NCT04070703|142919453|SUPERIORITY||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|1.6|2.8|||Mixed Models Analysis|||||2.8|1.6|<.05
71701601|NCT04070703|142919454|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||||.8|-.7|<.05
71701602|NCT04070703|142919454|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-3.1|-1.3|||Mixed Models Analysis|||||-1.3|-3.1|<.05
71701603|NCT04070703|142919455|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED|95.0|-0.3|1.2|||Mixed Models Analysis|||||1.2|-.3|<.05
71701604|NCT04070703|142919455|SUPERIORITY||Mean Difference (Final Values)|-1.0|||<|0.05|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||||-.2|-1.8|<.05
71701605|NCT04070703|142919456|SUPERIORITY||Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||||2|-.4|<.05
71701606|NCT04070703|142919456|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.05|TWO_SIDED|95.0|3.1|7.9|||Mixed Models Analysis|||||7.9|3.1|<.05
71701607|NCT04070703|142919457|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||.03|-.04|<.05
71701608|NCT04070703|142919457|SUPERIORITY||Mean Difference (Final Values)|0.07|||<|0.05|TWO_SIDED|95.0|0.03|0.11|||Mixed Models Analysis|||||.11|.03|<.05
71701609|NCT04070703|142919458|SUPERIORITY||Mean Difference (Final Values)|4.0|||<|0.05|TWO_SIDED|95.0|-2.0|6.0|||Mixed Models Analysis|||||6|-2|<.05
71701610|NCT04070703|142919458|SUPERIORITY||Mean Difference (Final Values)|125.5|||<|0.05|TWO_SIDED|95.0|84.0|166.0|||Mixed Models Analysis|||||166|84|<.05
71701611|NCT04070703|142919459|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.05|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis|||||-.1|-.3|<.05
71701612|NCT04070703|142919459|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.05|TWO_SIDED|95.0|-0.7|-0.4|||Mixed Models Analysis|||||-.4|-.7|<.05
71701613|NCT01081951|142919510|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0012|TWO_SIDED|95.0|0.34|0.77||The use of a one-sided 10% significance level test will be used to assess the statistical significance of the analyses of PFS.|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio of \< 1 favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||0.77|0.34|0.0012
71823353|NCT01823341|143149816|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71761957|NCT01396447|143025846|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0489|TWO_SIDED|95.0|-0.5|0.0|||Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.||-0.0|-0.5|0.0489
71823354|NCT01823341|143149816|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71660879|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.037
71660880|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.88||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.880
71660881|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.153||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.153
71660882|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.073||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.073
71660883|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.007
71660884|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.791||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.791
71660885|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.01||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.010
71660886|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.553||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.553
71660887|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.652||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.652
71660888|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
71660889|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.482
71660890|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.685||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.685
71660891|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.002
71660892|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.672||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.672
71660893|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.377||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.377
71660894|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.015
71660895|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.086
71660896|NCT03118570|142835397|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.712||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.712
71701614|NCT01081951|142919511|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.4379|TWO_SIDED|95.0|0.79|1.73||Two sided|Log Rank|Stratified by number of prior platinum treatment lines (1 or \>1) and time to progression following previous platinum therapy (\>6 to ≤12 vs \>12 months)|A hazard ratio \< 1 favours favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.||1.73|0.79|0.4379
71701615|NCT03806296|142919557|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.018|TWO_SIDED|95.0|-0.77|-0.07|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||-0.07|-0.77|0.018
71701616|NCT03806296|142919557|SUPERIORITY||Time X Group interaction|0.67||||0.001|TWO_SIDED|95.0|0.28|1.07|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||1.07|0.28|0.001
71701617|NCT03806296|142919558|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.61|1.59|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||1.59|0.61|<0.001
71701618|NCT03806296|142919558|SUPERIORITY||Time X Group interaction|-0.76|||<|0.001|TWO_SIDED|95.0|-1.09|-0.43|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||-0.43|-1.09|<0.001
71701619|NCT03806296|142919559|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.365|TWO_SIDED|95.0|-0.64|0.24|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.24|-0.64|0.365
71701620|NCT03806296|142919559|SUPERIORITY||Time X Group interaction|-0.43||||0.067|TWO_SIDED|95.0|-0.88|0.03|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.||0.03|-0.88|0.067
71701621|NCT03806296|142919560|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.234|TWO_SIDED|95.0|-2.18|8.82|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||8.82|-2.18|0.234
71701622|NCT03806296|142919560|SUPERIORITY||Time X Group interaction|-6.15||||0.018|TWO_SIDED|95.0|-11.25|-1.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||-1.06|-11.25|0.018
71701623|NCT03806296|142919561|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.024|TWO_SIDED|95.0|0.07|0.94|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.94|0.07|0.024
71701624|NCT03806296|142919561|SUPERIORITY||Time X Group interaction|-0.1||||0.66|TWO_SIDED|95.0|-0.55|0.35|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.35|-0.55|0.660
71761958|NCT00856518|143025869|SUPERIORITY_OR_OTHER|||||||0.899||||||EMST arm vs. Sham arm baseline MEP value comparison|Wilcoxon (Mann-Whitney)|||||||0.899
71761959|NCT00856518|143025869|SUPERIORITY_OR_OTHER|||||||0.946|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response||||||0.946
71701625|NCT03806296|142919562|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.592|TWO_SIDED|95.0|-0.03|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.03|0.592
71701626|NCT03806296|142919562|SUPERIORITY||Time X Group interaction|-0.03||||0.55|TWO_SIDED|95.0|-0.11|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.11|0.550
71701627|NCT03806296|142919563|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.55|TWO_SIDED|95.0|-0.07|0.04|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.04|-0.07|0.550
71701628|NCT03806296|142919563|SUPERIORITY||Time X Group interaction|-0.02||||0.556|TWO_SIDED|95.0|-0.1|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.10|0.556
71701629|NCT03806296|142919564|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.124|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.||0.06|-0.01|0.124
71701630|NCT03806296|142919564|SUPERIORITY||Time X Group interaction|0.0||||0.925|TWO_SIDED|95.0|-0.05|0.06|||Mixed Models Analysis|||For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.||0.06|-0.05|0.925
71701631|NCT03806296|142919565|SUPERIORITY||Risk Ratio (RR)|0.752||||0.42|TWO_SIDED|95.0|0.374|1.513|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (lower RR indicates less likelihood of cannabis use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary cannabis use outcome (yes/no in the past 3 months), accounting for age and sex.||1.513|0.374|0.42
71701632|NCT03806296|142919566|SUPERIORITY||Risk Ratio (RR)|1.236||||0.461|TWO_SIDED|95.0|0.704|2.171|||Poisson GLM with robust standard error||Early/Middle Sleep group was the reference group (higher RR indicates higher likelihood of alcohol use in the Late Sleep group)|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary alcohol use outcome (yes/no in the past 3 months), accounting for age and sex.||2.171|0.704|0.461
71701633|NCT03806296|142919566|SUPERIORITY||Incident Rate Ratio|3.29||||0.007|TWO_SIDED|95.0|1.36|7.9|||negative binomial glm||Early/Middle Sleep group was the reference group (higher IRR indicates greater days of alcohol use in the Late Sleep group than in the Early/Middle Sleep group).|For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a negative binomial GLM to test the effect of group (Early/Mid vs Late) on days of alcohol use, accounting for age and sex.||7.90|1.36|0.007
71701634|NCT04896385|142919568|OTHER|||||||0.004|||||||repeated measures correlation|||F-VASI||||0.004
71701635|NCT04896385|142919568|OTHER|||||||0.41|||||||repeated measures correlation|||F-VASI||||0.41
71701636|NCT04896385|142919568|OTHER|||||||0.0002|||||||repeated measures correlation|||T-VASI||||0.0002
71701637|NCT04896385|142919568|OTHER|||||||0.91|||||||repeated measures correlation|||T-VASI||||0.91
71701638|NCT05258721|142919573|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71701639|NCT05258721|142919574|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p =0.05|Kruskal-Wallis|||||||<0.001
71701640|NCT05258721|142919575|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71701641|NCT00848185|142919594|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||ANOVA for three groups||||<0.001
71701642|NCT00790036|142919598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.276|TWO_SIDED|95.0|0.69|1.22||P-value was obtained from the one-sided unstratified log rank test.|Log Rank|||||1.22|0.69|0.276
71701643|NCT00790036|142919599|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.52|1.09||There was no formal testing of the OS between treatment since the primary endpoint was not statistically significant.||||||1.09|0.52|
71701644|NCT00790036|142919600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.41|1.07||||||||1.07|0.41|
71701645|NCT04426656|142919614|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using the outcome variable measured at Week 12.||||0.85
71701646|NCT04426656|142919615|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71701647|NCT04426656|142919616|SUPERIORITY|||||||0.318|||||||Fisher Exact|||||||0.318
71701648|NCT04426656|142919617|SUPERIORITY|||||||0.527|||||||Fisher Exact|||||||0.527
71701649|NCT04426656|142919618|SUPERIORITY|||||||0.928|||||||Fisher Exact|||||||0.928
71701650|NCT04426656|142919619|SUPERIORITY|||||||0.678|||||||Fisher Exact|||||||0.678
71701651|NCT04426656|142919620|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The comparison test was made using the outcome variable measured at Week 12.||||0.26
71701652|NCT04426656|142919621|SUPERIORITY|||||||0.08|||||||Fisher Exact|||The comparison was made using data measured at Week 12.||||0.08
71701653|NCT04426656|142919622|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.03
71701654|NCT04426656|142919623|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||This comparison was made using data at Week 12.||||0.58
71701655|NCT04426656|142919624|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||The comparison was made using data measured at Week 12.||||0.85
71701656|NCT02595892|142919632|OTHER||Hazard Ratio (HR)|0.57||||0.044|TWO_SIDED|90.0|0.33|0.98|||Log Rank|||||.98|.33|0.044
71701657|NCT02595892|142919635|OTHER|||||||0.44|||||||Fisher Exact|Two-Sided Fisher's exact test.||||||0.44
71761960|NCT00856518|143025869|SUPERIORITY_OR_OTHER|||||||0.00042|||||||t-test, 2 sided|EMST arm post vs. pre-MEP comparison||||||0.00042
71660897|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.045||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.045
71660898|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.101||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.101
71660899|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.482||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 6||||0.482
71660900|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.011
71660901|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.508||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.508
71660902|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lean, Month 12||||0.563
71660903|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.917||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.917
71660904|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.789||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.789
71660905|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 6||||0.262
71660906|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.426||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.426
71660907|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.871||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.871
71660908|NCT03118570|142835399|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.113||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Fat, Month 12||||0.113
71660909|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71660910|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71660911|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.984||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||0.984
71660912|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||< 0.001
71660913|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
71660914|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.857||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.857
71660915|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.001
71660916|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.079||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.079
71660917|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.912||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.912
71701658|NCT00373672|142919705|SUPERIORITY||||||<|0.016|||||||t-test, 2 sided|||Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.||||<0.016
71701659|NCT04635423|142919752|SUPERIORITY||Observed Efficacy (%)|89.3|||<|0.001|TWO_SIDED|95.0|55.4|98.2||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||98.2|55.4|<0.001
71701660|NCT04635423|142919753|OTHER||Difference in Percentages|40.1|||||TWO_SIDED|95.0|34.5|45.5|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||45.5|34.5|
71701661|NCT04635423|142919754|OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-4.4|5.2|||Miettinen & Nurminen method||Difference in percentages calculated as % V503 minus % Placebo.|||5.2|-4.4|
71701662|NCT04635423|142919757|SUPERIORITY||Observed Efficacy (%)|63.5||||0.023|TWO_SIDED|95.0|2.7|86.0||one-sided p-value based on exact binomial method proposed by Chan and Bohidar|Exact Binomial Method Chan and Bohidar||The statistical criterion for success requires that the lower bound of the 2-sided 95% confidence interval (CI) for vaccine efficacy (VE) against the primary efficacy endpoint is greater than 0%.|||86.0|2.7|0.023
71701663|NCT05119569|142919785|SUPERIORITY||Rate Ratio|0.313||||0.0022|TWO_SIDED|95.0|0.149|0.658|||Negative Binomial Regression Model|||||0.658|0.149|0.0022
71701664|NCT05119569|142919786|SUPERIORITY||Rate Ratio|0.265||||0.0004|TWO_SIDED|95.0|0.128|0.55|||Negative Binomial Regression Model|||||0.550|0.128|0.0004
71701665|NCT05119569|142919787|SUPERIORITY||Odds Ratio (OR)|4.005||||0.0117|TWO_SIDED|95.0|1.317|13.078|||Logistic Regression Model|||||13.078|1.317|0.0117
71701666|NCT05119569|142919792|SUPERIORITY||Rate Ratio|0.78||||0.5889|TWO_SIDED|95.0|0.316|1.922|||Negative Binomial Regression Model|||||1.922|0.316|0.5889
71701667|NCT05119569|142919793|SUPERIORITY||Rate Ratio|0.076||||0.0011|TWO_SIDED|95.0|0.016|0.355|||Negative Binomial Regression Model|||||0.355|0.016|0.0011
71701668|NCT05119569|142919794|SUPERIORITY||Rate Ratio|0.104||||0.0038|TWO_SIDED|95.0|0.022|0.481|||Negative Binomial Regression Model|||||0.481|0.022|0.0038
71701669|NCT05119569|142919795|SUPERIORITY||Rate Ratio|0.512||||0.0958|TWO_SIDED|95.0|0.233|1.126|||Negative Binomial Regression Model|||||1.126|0.233|0.0958
71701670|NCT05119569|142919796|SUPERIORITY||Rate Ratio|0.105|||<|0.0001|TWO_SIDED|95.0|0.039|0.283|||Negative Binomial Regression Model|||||0.283|0.039|<0.0001
71701671|NCT05119569|142919797|SUPERIORITY||Rate Ratio|0.053||||0.0001|TWO_SIDED|95.0|0.012|0.233|||Negative Binomial Regression Model|||||0.233|0.012|0.0001
71701672|NCT00434434|142919801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.13
71701673|NCT00434434|142919801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0133
71701674|NCT00434434|142919802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.09
71701675|NCT00434434|142919802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney||||||0.0028
71701676|NCT02290184|142919804|SUPERIORITY_OR_OTHER|A multi-level regression was employed to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected confidence interval (CI).|cross-level interaction|-2.0|||||TWO_SIDED|0.05|-3.0|-1.1|||||"Multilevel regression analysis was used. The primary test of between-group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.||-1.1|-3.0|
71701677|NCT02290184|142919805|SUPERIORITY|Multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.6|||||TWO_SIDED|0.05|-3.9|-1.4|||||"Multilevel regression was used. The primary test of between group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months||-1.4|-3.9|
71701678|NCT02290184|142919806|SUPERIORITY|A multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.7|||||TWO_SIDED|95.0|-4.5|-0.91|||||"Multilevel regression was used. The primary test of between -group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months||-.91|-4.5|
71701679|NCT01069939|142919807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.09|||<|0.001|TWO_SIDED|96.65|0.02|0.41||An interim analysis was done so that the significance level was adjusted using the Pocock-like alpha-spending function with Lan-DeMets approach. The adjusted significance level was the two-sided 3.35%.|Log Rank|||The above two groups were compared.||0.41|0.02|<0.001
71701680|NCT01017250|142919847|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.04
71701681|NCT01017250|142919848|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
71701682|NCT01017250|142919849|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.02
71701683|NCT01017250|142919850|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.0005
71701684|NCT01017250|142919851|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.53
71701685|NCT01017250|142919852|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.002
71701686|NCT01017250|142919853|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.76
71701687|NCT01017250|142919854|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.||||0.34
71701688|NCT02112916|142919871|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.074|TWO_SIDED|95.0|0.561|1.091|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the EFS of the randomized patients (T-ALL+T-LLy) on Arm A vs Arm B. Study was designed to accrue 1200 eligible, evaluable randomized patients (to provide 90.5% power to detect an improvement in 4-year EFS from 85% to 90% with an alpha of 0.05 (one-sided log-rank test) (Hazard Ratio (HR)=0.6483). Study was closed to accrual early due to results from AALL0434 for nelarabine.||1.091|0.561|0.074
71701689|NCT04835441|142919883|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
71701690|NCT04835441|142919884|SUPERIORITY|||||||0.308|||||||Cochran-Mantel-Haenszel|||||||0.308
71701691|NCT04835441|142919885|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
71701692|NCT04835441|142919886|SUPERIORITY|||||||0.788|||||||Kaplan-Meier methods|||||||0.788
71701693|NCT04835441|142919887|SUPERIORITY|||||||0.792|||||||Cochran-Mantel-Haenszel|||||||0.792
71701694|NCT04835441|142919888|SUPERIORITY|||||||0.302|||||||Mixed models for repeated measures|||||||0.302
71701695|NCT04835441|142919889|SUPERIORITY|||||||0.506|||||||ANOVA|||||||0.506
71701696|NCT04835441|142919890|SUPERIORITY|||||||0.659|||||||Fisher Exact|||||||0.659
71701697|NCT03323502|142919912|SUPERIORITY||Incidence Rate Ratio (IRR)|0.94|STANDARD_ERROR_OF_MEAN|0.062||0.3164|TWO_SIDED|95.0|0.83|1.06|||Poisson Regression|||||1.06|0.83|0.3164
71701698|NCT03323502|142919913|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4828|TWO_SIDED|95.0|0.8|1.11|||Regression, Logistic|||||1.11|0.80|0.4828
71701699|NCT03323502|142919914|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3946|TWO_SIDED|95.0|0.85|1.49|||Regression, Logistic|||||1.49|0.85|0.3946
71701700|NCT00975923|142919915|SUPERIORITY_OR_OTHER||infection rates per device days|2.0|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|95.0|1.0|3.0||p-value and confidence intervals|Regression, Linear|||Infection rates were analyzed using hierarchical negative binomial regression models to model infection rate changes over time and account for clustering of ICUs within hospitals and adjusting for baseline covariates. Power was calculated a priori with a 1-tailed alpha of 0.05 and group size of 30; a 50% decrease in infection rates in the Collaborative group and 15% for the Tool Kit group, yielding power ranging from 82% to 91% for testing group differences.||3.0|1.0|<.05
71701701|NCT00975923|142919916|SUPERIORITY_OR_OTHER||percentages|10.0|||<|5|TWO_SIDED|95.0|||||Chi-squared||Power calculation used alpha = .05 and group size = 30.The estimated effect was a 50% decrease in infection rates for the Collaborative Group and from 10% to 15% decrease in the Tool Kit group.Power ranged from 82%-91% for testing group differences.|It was hypothesized that the Collaborative group would engage in more processes and tools than the Tool Kit group. Power was based on infection rates.||||<05
71701702|NCT02612155|142919935|OTHER|||||||0.06|||||||Fisher Exact|||||||0.06
71701703|NCT04435626|142919961|SUPERIORITY||Rate ratio|0.84||||0.0072|TWO_SIDED|95.0|0.74|0.95||Two-sided p-value; p-value threshold =0.04967;|stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.95|0.74|0.0072
71701704|NCT04435626|142919963|SUPERIORITY||Rate ratio|0.82||||0.0062|TWO_SIDED|95.0|0.71|0.94||Two-sided p-value; p-value threshold=0.04967;|Stratified Andersen-Gill model|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|stratified Andersen-Gill model with robust sandwich estimate for the covariance matrix of recurrent events|Rate Ratio (Finerenone/Placebo)||0.94|0.71|0.0062
71701705|NCT04435626|142919965|OTHER|mixed-effects model for repeated measures (MMRM)|Difference in LS Mean|1.56|||<|0.0001|TWO_SIDED|95.0|0.79|2.34||Two-sided p-value;|Mixed Models Analysis|The analysis was performed using mixed-effects model for repeated measures (MMRM)||Difference in LS Mean||2.34|0.79|<.0001
71701706|NCT04435626|142919966|OTHER|Logistic regression analysis|Odds Ratio (OR)|1.01||||0.9295|TWO_SIDED|95.0|0.88|1.15||Two-sided p-value|Regression, Logistic|||Odds ratio (finerenone /placebo)||1.15|0.88|0.9295
71701707|NCT04435626|142919967|OTHER|Stratified log-rank test|Cause-specific Hazard Ratio|1.33||||0.1071|TWO_SIDED|95.0|0.94|1.89||two-sided p-value|Stratified log-rank test||stratified Cox proportional hazards model|Cause-specific Hazard Ratio||1.89|0.94|0.1071
71701708|NCT04435626|142919968|OTHER|Stratified log-rank test|cause-specific hazard ratio|0.93||||0.2794|TWO_SIDED|95.0|0.83|1.06||two-sided p-value|stratified log-rank||stratified Cox proportional hazards model|Hazard Ratio||1.06|0.83|0.2794
71701709|NCT05252702|142920001|SUPERIORITY|"The primary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFR ≤ 78% vs. H1: CFR \> 78%~where 78% was the performance goal (PG)."|binomial proportion|90.3|||<|0.0001|ONE_SIDED|97.5|87.0|||The CFR was estimated as a binomial proportion and a one-sided 97.5% lower confidence bound of the CFR was calculated using the normal approximation. The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was calculated and compared to the 0.025 significance level.|||||87|<0.0001
71761961|NCT00856518|143025869|SUPERIORITY_OR_OTHER|||||||0.0019||||||Sham arm post vs. pre-MEP comparison|t-test, 2 sided|||||||0.0019
71823355|NCT01823341|143149817|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
71701710|NCT05252702|142920002|SUPERIORITY|"The primary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFR ≤ 76.5% vs. H1: CFR \> 76.5%~where 76.5% is the performance goal. The CFR was estimated using a Kaplan-Meier survival analysis and the 97.5% lower confidence bound of CFR was calculated using the Greenwood variance estimates."|Kaplan-Meier|88.6|||<|0.0001|ONE_SIDED|97.5|84.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 76.5%.|one-sided Z-test|The p-value for the one-sided Z-test was calculated and compared to the 2.5% significance level.|||||84.5|<0.0001
71701711|NCT05252702|142920003|SUPERIORITY||binomial proportion|90.8|||<|0.0001|ONE_SIDED|97.5|87.5|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 82.5%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #1 hypothesis at 3 month was formally expressed as:~H0: Rate ≤ 82.5% vs. H1: Rate \> 82.5%~where 82.5% was the performance goal (PG)."|||87.5|<0.0001
71701712|NCT05252702|142920004|SUPERIORITY||binomial proportion|92.8|||<|0.0001|ONE_SIDED|97.5|89.7|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 80%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The Rate at 12 months was estimated as a binomial proportion and the one-sided 97.5% LCB of the Rate was calculated using the normal approximation.|"The primary effectiveness endpoint #1 hypothesis at 12 months was formally expressed as:~H0: Rate ≤ 80% vs. H1: Rate \> 80%~where 80% was the performance goal (PG)."|||89.7|<0.0001
71701713|NCT05252702|142920005|SUPERIORITY||binomial proportion|98.2|||<|0.0001|ONE_SIDED|97.5|96.6|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the PG of 83%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.||"The primary effectiveness endpoint #2 hypothesis was formally expressed as:~H0: RateAV ≤ 83% vs. H1: RateAV \> 83%~where 83% is the performance goal."|||96.6|<0.0001
71701714|NCT05252702|142920006|SUPERIORITY||binomial proportion|91.3||||0.0003|ONE_SIDED|97.5|88.1|||The null hypothesis was to be rejected at the 2.5% significance level if the lower confidence bound exceeded the Performance Goal (PG) of 84%.|one-sided Z-test|The p-value from a one-sided Z-test for the binomial proportion was to be calculated and compared to the 0.025 significance level.||"The secondary safety endpoint hypothesis at 3 months was formally expressed as:~H0: CFRA ≤ 84% vs. H1: CFRA \> 84%~where 84% was the performance goal."|||88.1|0.0003
71701715|NCT05252702|142920007|SUPERIORITY||Kaplan-Meier|91.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|ONE_SIDED|97.5|87.1|||The null hypothesis was to be rejected at the 2.5% significance level if the LCB exceeded the Performance Goal (PG) of 82%.|one-sided Z-test|The p-value for the one-sided Z-test was to be calculated and compared to the 2.5% significance level.|The 97.5% lower confidence bound (LCB) of CFRA was calculated using the Greenwood variance estimates.|"The secondary safety endpoint hypothesis at 12 months was formally expressed as:~H0: CFRA ≤ 82% vs. H1: CFRA \> 82%~where 82% is the performance goal."|||87.1|<0.0001
71701716|NCT05252702|142920008|OTHER||mixed effects model for repeated measure|0.91|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.78|1.04|||t-test, 1 sided|Two one-sided t-tests (TOST), with an alpha level of 0.025, and n-1 degrees of freedom.||"An analysis of these data provided an estimate of the 95% confidence interval for the mean slope across analyzable subjects, which had a pre-specified success criterion requiring that this confidence interval must fall between slopes of 65% and 135%. The following hypothesis was evaluated:~H0: Mean Slope \< 0.65 or Mean Slope \> 1.35~H1: 0.65 ≤ Mean Slope ≤ 1.35"||1.04|0.78|<0.001
71701717|NCT04871074|142920073|SUPERIORITY|||||||0.74|||||||DeLong's Test|||||||.74
71701718|NCT04871074|142920074|SUPERIORITY|||||||0.66|||||||DeLong's Test|||||||.66
71701719|NCT04871074|142920075|SUPERIORITY|||||||0.135|||||||Mixed Models Analysis|Linear mixed effects model, fixed effects coefficient test with a Wald test||||||.135
71701720|NCT04871074|142920079|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Fixed effects estimate, Wald test||||||.39
71701721|NCT00098475|142920092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.|Difference in response rate between arms|0.107|||||TWO_SIDED|80.0|0.052|0.162||||||The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.||0.162|0.052|
71701722|NCT06354257|142920094|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of EE.||1.41|0.55|
71701723|NCT06354257|142920094|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.98|1.23|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the AUC(0-inf) of LNG.||1.23|0.98|
71701724|NCT06354257|142920095|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of EE.||1.09|0.85|
71761962|NCT00856518|143025871|SUPERIORITY_OR_OTHER||||||>|0.05||||||EMST arm vs. Sham arm baseline total score and subscale score comparison|Wilcoxon (Mann-Whitney)|||||||> 0.05
71823356|NCT01823341|143149817|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
71701725|NCT06354257|142920095|EQUIVALENCE|The 90% CI for each ratio was compared to 0.8 and 1.25.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.97|1.19|||Mixed Models Analysis|Analysis was performed using linear mixed effect models with treatment as a fixed effect and subject as a random effect.|One-sided tests (alpha=0.05) were used. 90% CIs for each ratio were compared to 0.8-1.25. No drug interaction is shown if CIs for AUC(0-inf) and Cmax of EE and LNG fall within 0.8-1.25.|A confirmatory hypothesis testing to test the effect of GSK3036656 on the Cmax of LNG.||1.19|0.97|
71761963|NCT00856518|143025871|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains||||||> 0.05
71823357|NCT01823341|143149818|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
71641542|NCT01141374|142802182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0667|STANDARD_DEVIATION|17.28||0.352|TWO_SIDED|95.0|-76.0|23.0||The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p\<0.05.|ANOVA|||Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.||23.00|-76.00|0.352
71641543|NCT01141374|142802183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9067|STANDARD_DEVIATION|19.21||0.023|TWO_SIDED|95.0|-67.0|37.0||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||37.00|-67.00|0.023
71701726|NCT02512419|142920131|SUPERIORITY||regression parameter (median diff)|37.52|STANDARD_ERROR_OF_MEAN|18.01||0.04|TWO_SIDED||||||quantile regression|Models regressed outcome at 6 months on treatment assigned, baseline value of the outcome and actigraph wear time. Effect sizes reported are adjusted|Effects are unstandardized regression coefficients. They represent difference in median outcome between conditions at 6m controlling for baseline and covariates.|To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjusted||||.04
71701727|NCT02512419|142920132|SUPERIORITY||Median Difference (Final Values)|42.36|STANDARD_ERROR_OF_MEAN|38.83||0.1|TWO_SIDED||||||quantile regression|||Quantile regression was used.||||0.10
71701728|NCT04738487|142920141|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6712|TWO_SIDED|95.0|0.83|1.35||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.35|0.83|0.6712
71701729|NCT04738487|142920142|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.332|TWO_SIDED|95.0|0.82|1.13||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.13|0.82|0.3320
71701730|NCT04738487|142920143|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1646|TWO_SIDED|95.0|0.72|1.11||One-sided p-value based on log-rank test.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.11|0.72|0.1646
71701731|NCT03976375|142920191|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4342|TWO_SIDED|95.0|0.78|1.23||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.23|0.78|0.4342
71701732|NCT03976375|142920192|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1563|TWO_SIDED|95.0|0.7|1.12||Stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50)|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.12|0.70|0.1563
71701733|NCT03976375|142920193|SUPERIORITY||Difference in Percentage vs Docetaxel|8.4||||0.01818|TWO_SIDED|95.0|0.5|16.3||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen and Nurminen method||Based on Miettinen \& Nurminen method stratified by Baseline ECOG performance status (0 versus 1), anti-PD-1/PD-L1 mAb (immediate prior therapy versus not the immediate prior therapy), and Baseline PD-L1 Status (\<50% versus \>=50%)|||16.3|0.5|0.01818
71701734|NCT03976375|142920194|SUPERIORITY||Difference in Percentage vs Lenvatinib|10.2||||0.06009|TWO_SIDED|95.0|-3.1|19.9||One-sided p-value for testing. H0: difference in % =0 versus H1: difference in % \> 0.|Miettinen & Nurminen method|||||19.9|-3.1|0.06009
71701735|NCT03976375|142920198|OTHER||Difference in least squares means|-1.36||||0.4998|TWO_SIDED|95.0|-5.32|2.6|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||2.60|-5.32|0.4998
71641544|NCT03134222|142802198|SUPERIORITY|||||||0.75|||||||Mixed-effect repeated measures model|||||||0.7500
71641545|NCT03134222|142802198|SUPERIORITY|||||||0.3047|||||||Mixed-effect repeated measures model|||||||0.3047
71641546|NCT03134222|142802199|SUPERIORITY|||||||0.8869|||||||Cochran-Mantel-Haenszel|||||||0.8869
71641547|NCT03134222|142802199|SUPERIORITY|||||||0.3293|||||||Cochran-Mantel-Haenszel|||||||0.3293
71641548|NCT03134222|142802200|SUPERIORITY|||||||0.7456|||||||Cochran-Mantel-Haenszel|||||||0.7456
71641549|NCT03134222|142802200|SUPERIORITY|||||||0.6407|||||||Cochran-Mantel-Haenszel|||||||0.6407
71641550|NCT03134222|142802201|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71641551|NCT03134222|142802201|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71641552|NCT03134222|142802202|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71641553|NCT03134222|142802202|OTHER||||||<|0.0001|||||||One sample exact binomial test|||||||<0.0001
71641554|NCT03482882|142802211|OTHER||LSM|-10.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-12.0|-9.5|||Mixed-effect model repeated measures|||||-9.5|-12.0|<0.0001
71641555|NCT00913627|142802219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|||<|0.001|TWO_SIDED|95.0|12.13|20.19||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.19|12.13|<0.001
71641556|NCT00913627|142802219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||<|0.001|TWO_SIDED|95.0|13.02|20.99||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||20.99|13.02|<0.001
71641557|NCT00913627|142802219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|8.33|16.26||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA|||||16.26|8.33|<0.001
71641558|NCT00913627|142802220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34|||<|0.001|TWO_SIDED|95.0|4.3|8.38||p-value adjusted for baseline PSR and gender|ANOVA|||||8.38|4.30|<0.001
71641559|NCT00913627|142802220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|||<|0.001|TWO_SIDED|95.0|5.05|9.08||p-value adjusted for baseline PSR and gender|ANOVA|||||9.08|5.05|<0.001
71641560|NCT00913627|142802220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.05|||<|0.001|TWO_SIDED|95.0|3.04|7.06||p-value adjusted for baseline PSR and gender|ANOVA|||||7.06|3.04|<0.001
71641561|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-55.83|-88.56|<0.001
71641562|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-54.30|-87.14|<0.001
71641563|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-59.6|||<|0.001|TWO_SIDED|95.0|-76.94|-42.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours||-42.27|-76.94|<0.001
71701736|NCT03976375|142920199|OTHER||Difference in Least Squares Mean|-3.86||||0.1531|TWO_SIDED|95.0|-9.16|1.44|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||1.44|-9.16|0.1531
71701737|NCT03976375|142920200|OTHER||Difference in Least Squares Means|2.48||||0.3084|TWO_SIDED|95.0|-2.31|7.27|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, timing of anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.27|-2.31|0.3084
71701738|NCT03976375|142920201|OTHER||Difference in Least Squares Means|-8.04||||0.0058|TWO_SIDED|95.0|-13.73|-2.35|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||-2.35|-13.73|0.0058
71701739|NCT03976375|142920202|OTHER||Difference in Least Squares Means|2.89||||0.1681|TWO_SIDED|95.0|-1.23|7.01|||t-test, 2 sided||Based on cLDA model with covariates for treatment by time interaction, stratification factors of baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and baseline PD-L1 Status|||7.01|-1.23|0.1681
71701740|NCT03976375|142920203|OTHER||Hazard Ratio (HR)|0.91||||0.6145|TWO_SIDED|95.0|0.63|1.31||stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.31|0.63|0.6145
71701741|NCT03976375|142920204|OTHER||Hazard Ratio (HR)|0.61||||0.0398|TWO_SIDED|95.0|0.38|0.98|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||0.98|0.38|0.0398
71701742|NCT03976375|142920205|OTHER||Hazard Ratio (HR)|1.05||||0.8724|TWO_SIDED|95.0|0.59|1.85|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status|||1.85|0.59|0.8724
71701743|NCT03976375|142920206|OTHER||Hazard Ratio (HR)|0.75||||0.1944|TWO_SIDED|95.0|0.49|1.16||Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Log Rank||Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.49|0.1944
71701744|NCT03976375|142920207|OTHER||Hazard Ratio (HR)|1.0||||0.9837|TWO_SIDED|95.0|0.71|1.41|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.41|0.71|0.9837
71701745|NCT03976375|142920208|OTHER||Hazard Ratio (HR)|0.84||||0.2903|TWO_SIDED|95.0|0.6|1.16|||Log Rank|Stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|Based on stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by Baseline ECOG performance status, anti-PD-1/PD-L1 mAb therapy, and Baseline PD-L1 Status.|||1.16|0.60|0.2903
71701746|NCT01922934|142920269|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71701747|NCT02354118|142920277|NON_INFERIORITY|10% non-inferiority margin||||||1|||||||Chi-squared|||||||1.0
71701748|NCT01706328|142920349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.137|TWO_SIDED|95.0|-0.008|0.059|||ANCOVA|||||0.059|-0.008|0.137
71701749|NCT03160170|142920352|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71701750|NCT03160170|142920353|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71701751|NCT03160170|142920354|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71701752|NCT03018938|142920355|NON_INFERIORITY|If Lower limit (L) \>-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) \<0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established|LS Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.0959||0.1009|TWO_SIDED|95.0|-0.346|0.031|||ANCOVA|||||0.031|-0.346|0.1009
71701753|NCT03018938|142920356|SUPERIORITY||LS Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.0891||0.0246|TWO_SIDED|95.0|-0.376|-0.026|||ANCOVA|||||-0.026|-0.376|0.0246
71701754|NCT03018938|142920357|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0941|TWO_SIDED|95.0|0.95|1.87|||Regression, Logistic|||||1.87|0.95|0.0941
71701755|NCT03018938|142920358|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8592|TWO_SIDED|95.0|0.72|1.49|||Regression, Logistic|||||1.49|0.72|0.8592
71701756|NCT03018938|142920359|SUPERIORITY||LS Mean Difference (Final Values)|0.423|STANDARD_ERROR_OF_MEAN|0.2152||0.0497|TWO_SIDED|95.0|0.0|0.846|||ANCOVA|||||0.846|0.000|0.0497
71701757|NCT03018938|142920360|SUPERIORITY||LS Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.1955||0.001|TWO_SIDED|95.0|0.263|1.031|||ANCOVA|||||1.031|0.263|0.0010
71701758|NCT03018938|142920361|SUPERIORITY||LS Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.2191||0.2193|TWO_SIDED|95.0|-0.161|0.7|||ANCOVA|||FBG||0.700|-0.161|0.2193
71701759|NCT03018938|142920361|SUPERIORITY||LS Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.3331||0.8014|TWO_SIDED|95.0|-0.739|0.571|||ANCOVA|||PPG||0.571|-0.739|0.8014
71701760|NCT03018938|142920362|SUPERIORITY||LS Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.2033||0.016|TWO_SIDED|95.0|0.092|0.891|||ANCOVA|||FBG||0.891|0.092|0.0160
71701761|NCT03018938|142920362|SUPERIORITY||LS Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.3028||0.9661|TWO_SIDED|95.0|-0.608|0.582|||ANCOVA|||PPG||0.582|-0.608|0.9661
71701762|NCT03018938|142920364|SUPERIORITY||LS Mean Difference|0.667|STANDARD_ERROR_OF_MEAN|0.2776||0.0166|TWO_SIDED|95.0|0.122|1.211|||ANCOVA|||||1.211|0.122|0.0166
71701763|NCT03018938|142920365|SUPERIORITY||LS Mean Difference (Final Values)|0.754|STANDARD_ERROR_OF_MEAN|0.2864||0.0086|TWO_SIDED|95.0|0.192|1.316|||ANCOVA|||||1.316|0.192|0.0086
71701764|NCT03018938|142920368|SUPERIORITY||Odds Ratio (OR)|1.25||||0.2009|TWO_SIDED|95.0|0.89|1.77|||Regression, Logistic|||||1.77|0.89|0.2009
71701765|NCT03018938|142920369|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8054|TWO_SIDED|95.0|0.72|1.53|||Regression, Logistic|||||1.53|0.72|0.8054
71641564|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|TWO_SIDED|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-55.83|-88.56|<0.001
71641565|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-54.30|-87.14|<0.001
71641566|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-57.79|||<|0.001|TWO_SIDED|95.0|-75.43|-40.16||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours||-40.16|-75.43|<0.001
71641567|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-66.79|||<|0.001|TWO_SIDED|95.0|-83.98|-49.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-49.60|-83.98|<0.001
71641568|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|TWO_SIDED|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-54.30|-87.14|<0.001
71641569|NCT00913627|142802223|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH)|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours||-38.11|-73.85|<0.001
71641570|NCT00913627|142802223|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-46.06|-80.82|<0.001
71641571|NCT00913627|142802223|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-68.88|||<|0.001|TWO_SIDED|95.0|-85.63|-54.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-54.14|-85.63|<0.001
71641572|NCT00913627|142802223|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.98|||<|0.001|TWO_SIDED|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours||-38.11|-73.85|<0.001
71641573|NCT00913627|142802223|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-63.44|||<|0.001|TWO_SIDED|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-46.06|-80.82|<0.001
71641574|NCT00913627|142802223|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-65.28|||<|0.001|TWO_SIDED|95.0|-82.49|-48.07||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-48.07|-82.49|<0.001
71641575|NCT00913627|142802223|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-50.77|||<|0.001|TWO_SIDED|95.0|-69.09|-32.45||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours||-32.45|-69.09|<0.001
71641576|NCT00913627|142802224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34|||<|0.001|TWO_SIDED|95.0|4.18|6.51||p-value adjusted for baseline PSR, and gender|ANOVA|||SPID 0-4||6.51|4.18|<0.001
71641577|NCT00913627|142802224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.001|TWO_SIDED|95.0|4.09|6.4||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||6.40|4.09|<0.001
71641578|NCT00913627|142802224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.83|5.12||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4||5.12|2.83|<0.001
71641579|NCT00913627|142802224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.53|||<|0.001|TWO_SIDED|95.0|5.63|9.43||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.43|5.63|<0.001
71641580|NCT00913627|142802224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68|||<|0.001|TWO_SIDED|95.0|5.8|9.56||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||9.56|5.80|<0.001
71641581|NCT00913627|142802224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|||<|0.001|TWO_SIDED|95.0|3.62|7.36||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8||7.36|3.62|<0.001
71641582|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.47|||<|0.001|TWO_SIDED|95.0|10.68|16.27||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.27|10.68|<0.001
71641583|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.24|||<|0.001|TWO_SIDED|95.0|10.48|16.01||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||16.01|10.48|<0.001
71641584|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001|TWO_SIDED|95.0|7.33|12.83||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4||12.83|7.33|<0.001
71641585|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.21|||<|0.001|TWO_SIDED|95.0|14.71|23.71||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.71|14.71|<0.001
71641586|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.32|||<|0.001|TWO_SIDED|95.0|14.86|23.78||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||23.78|14.86|<0.001
71641587|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.87|||<|0.001|TWO_SIDED|95.0|9.44|18.3||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8||18.30|9.44|<0.001
71641588|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.18|||<|0.001|TWO_SIDED|95.0|11.29|21.07||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||21.07|11.29|<0.001
71641589|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.65|||<|0.001|TWO_SIDED|95.0|12.81|22.49||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||22.49|12.81|<0.001
71641590|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.78|||<|0.001|TWO_SIDED|95.0|7.97|17.59||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12||17.59|7.97|<0.001
71641591|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.08|||<|0.001|TWO_SIDED|95.0|31.48|50.69||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||50.69|31.48|<0.001
71641592|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.66|||<|0.001|TWO_SIDED|95.0|33.15|52.17||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||52.17|33.15|<0.001
71641593|NCT00913627|142802225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|||<|0.001|TWO_SIDED|95.0|21.63|40.53||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12||40.53|21.63|<0.001
71641594|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.13|||<|0.001|TWO_SIDED|95.0|6.45|9.8||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.80|6.45|<0.001
71641595|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|||<|0.001|TWO_SIDED|95.0|6.34|9.65||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||9.65|6.34|<0.001
71641596|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11|||<|0.001|TWO_SIDED|95.0|4.46|7.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4||7.75|4.46|<0.001
71641597|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001|TWO_SIDED|95.0|9.02|14.34||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.34|9.02|<0.001
71641598|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.64|||<|0.001|TWO_SIDED|95.0|9.01|14.27||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||14.27|9.01|<0.001
71641599|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.001|TWO_SIDED|95.0|5.76|11.0||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8||11.00|5.76|<0.001
71641600|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84|||<|0.001|TWO_SIDED|95.0|6.93|12.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||12.75|6.93|<0.001
71641601|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.59|||<|0.001|TWO_SIDED|95.0|7.71|13.46||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||13.46|7.71|<0.001
71641602|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.73|||<|0.001|TWO_SIDED|95.0|4.87|10.59||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12||10.59|4.87|<0.001
71641603|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.93|||<|0.001|TWO_SIDED|95.0|19.24|30.61||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||30.61|19.24|<0.001
71641604|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.66|||<|0.001|TWO_SIDED|95.0|20.03|31.28||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||31.28|20.03|<0.001
71641605|NCT00913627|142802226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.78|||<|0.001|TWO_SIDED|95.0|13.19|24.38||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12||24.38|13.19|<0.001
71641606|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.31||||0.08|TWO_SIDED|95.0|1.26|25.36||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||25.36|1.26|0.080
71641607|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.39||||0.043|TWO_SIDED|95.0|3.73|29.04||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||29.04|3.73|0.043
71641608|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.39||||0.354|TWO_SIDED|95.0|-4.62|15.4||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||15.40|-4.62|0.354
71641609|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.65|||<|0.001|TWO_SIDED|95.0|33.34|63.96||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||63.96|33.34|<0.001
71641610|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.94|||<|0.001|TWO_SIDED|95.0|37.15|66.73||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||66.73|37.15|<0.001
71641611|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.8|||<|0.001|TWO_SIDED|95.0|22.62|50.98||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||50.98|22.62|<0.001
71641612|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.39|||<|0.001|TWO_SIDED|95.0|41.2|73.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||73.57|41.20|<0.001
71641613|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|66.67|||<|0.001|TWO_SIDED|95.0|51.56|81.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||81.78|51.56|<0.001
71641614|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.2|||<|0.001|TWO_SIDED|95.0|34.2|66.21||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||66.21|34.20|<0.001
71641615|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|67.64|||<|0.001|TWO_SIDED|95.0|51.36|83.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||83.93|51.36|<0.001
71641616|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|70.61|||<|0.001|TWO_SIDED|95.0|55.16|86.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||86.05|55.16|<0.001
71701766|NCT03018938|142920370|SUPERIORITY||LS Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7553|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|||||0.5|-0.8|0.7553
71641617|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.85|||<|0.001|TWO_SIDED|95.0|34.32|69.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||69.38|34.32|<0.001
71641618|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||85.33|53.33|<0.001
71641619|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|74.21|||<|0.001|TWO_SIDED|95.0|59.29|89.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||89.14|59.29|<0.001
71641620|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.84|41.88|<0.001
71641621|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||85.33|53.33|<0.001
71641622|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||92.06|63.57|<0.001
71641623|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||75.84|41.88|<0.001
71641624|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||85.33|53.33|<0.001
71641625|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||92.06|63.57|<0.001
71641626|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||75.84|41.88|<0.001
71701767|NCT01769586|142920371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Chi-squared|||||.50|.24|<0.001
71701768|NCT02811159|142920372|OTHER|||||||0.1797|||||||Chi-Square Test|||||||0.1797
71641627|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||85.33|53.33|<0.001
71641628|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||92.06|63.57|<0.001
71641629|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||75.84|41.88|<0.001
71641630|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||85.33|53.33|<0.001
71641631|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||92.06|63.57|<0.001
71641632|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.84|41.88|<0.001
71641633|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
71641634|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
71641635|NCT00913627|142802227|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
71641636|NCT00913627|142802228|SUPERIORITY_OR_OTHER||Hazard Ratio, log|13.56|||<|0.001|TWO_SIDED|95.0|4.85|37.89||p-value adjusted for gender and categorical baseline pain severity|Proportional hazards regression|||||37.89|4.85|<0.001
71641637|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|2.03||||0.434|TWO_SIDED|95.0|-1.95|6.02||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||6.02|-1.95|0.434
71641638|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Cochran-Mantel-Haenszel|||15 minutes||0.00|0.00|
71641639|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.78||||0.469|TWO_SIDED|95.0|-1.71|5.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes||5.27|-1.71|0.469
71641640|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.13||||0.101|TWO_SIDED|95.0|1.33|16.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||16.93|1.33|0.101
71641641|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.73||||0.069|TWO_SIDED|95.0|2.54|18.91||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||18.91|2.54|0.069
71641642|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.59||||0.303|TWO_SIDED|95.0|-1.39|8.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes||8.57|-1.39|0.303
71641643|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|24.58||||0.008|TWO_SIDED|95.0|10.68|38.47||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||38.47|10.68|0.008
71641644|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|25.31||||0.007|TWO_SIDED|95.0|11.35|39.28||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||39.28|11.35|0.007
71641645|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.62||||0.129|TWO_SIDED|95.0|-0.68|21.92||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes||21.92|-0.68|0.129
71641646|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|47.72|||<|0.001|TWO_SIDED|95.0|32.25|63.19||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||63.19|32.25|<0.001
71641647|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|36.01|||<|0.001|TWO_SIDED|95.0|21.24|50.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||50.78|21.24|<0.001
71641648|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|27.87||||0.003|TWO_SIDED|95.0|13.93|41.81||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes||41.81|13.93|0.003
71641649|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|61.01|||<|0.001|TWO_SIDED|95.0|46.12|75.89||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||75.89|46.12|<0.001
71641650|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.83|||<|0.001|TWO_SIDED|95.0|38.85|68.8||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||68.80|38.85|<0.001
71641651|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|31.89|61.58||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes||61.58|31.89|<0.001
71641652|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.78|||<|0.001|TWO_SIDED|95.0|49.37|80.18||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||80.18|49.37|<0.001
71641653|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|64.8|||<|0.001|TWO_SIDED|95.0|50.01|79.59||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||79.59|50.01|<0.001
71641654|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.19|||<|0.001|TWO_SIDED|95.0|34.27|66.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes||66.11|34.27|<0.001
71641655|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|68.59|||<|0.001|TWO_SIDED|95.0|52.81|84.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||84.38|52.81|<0.001
71641656|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.16|||<|0.001|TWO_SIDED|95.0|57.05|87.26||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||87.26|57.05|<0.001
71641657|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.47|||<|0.001|TWO_SIDED|95.0|36.57|70.37||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes||70.37|36.57|<0.001
71641658|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||87.84|57.48|<0.001
71701769|NCT02811159|142920373|OTHER|||||||0.125|||||||Wilcoxon Signed-Rank Test|||||||0.1250
71701770|NCT02811159|142920374|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
71701771|NCT02811159|142920375|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
71701772|NCT02811159|142920376|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
71701773|NCT02811159|142920377|OTHER|||||||1|||||||Wilcoxon Signed-Rank Test|||||||1.0000
71701774|NCT02811159|142920378|OTHER|||||||0.875|||||||Wilcoxon Signed-Rank Test|||||||0.8750
71701775|NCT02811159|142920379|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
71701776|NCT02811159|142920380|OTHER|||||||0.5|||||||Wilcoxon Signed-Rank Test|||||||0.5000
71823358|NCT01823341|143149818|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
71641659|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|79.36|||<|0.001|TWO_SIDED|95.0|65.68|93.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||93.05|65.68|<0.001
71701777|NCT02811159|142920381|OTHER|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.2500
71701778|NCT02811159|142920382|OTHER|||||||0.0645|||||||Wilcoxon Signed-Rank Test|||||||0.0645
71701779|NCT00191100|142920384|SUPERIORITY_OR_OTHER||PFS Probability Difference at 3 Years|0.095||||0.029||95.0|0.01|0.179||The p-value is two-sided and was tested at the 0.05 significance level.|Z Statistic||Difference in progression-free survival probability between Gem/Cis/Rad and Cis/Rad. The difference in PFS probability between the two treatment arms can also be presented as a percentage (ie, PFS at 3 years was 9.5% better in the Gem/Cis/Rad arm).|||0.179|0.010|0.029
71701780|NCT00191100|142920385|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Log Rank|||||||0.0008
71701781|NCT00191100|142920386|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||"Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure."||||0.096
71701782|NCT00191100|142920387|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||||||0.250
71701783|NCT00191100|142920388|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Log Rank|||||||0.0224
71701784|NCT00191100|142920389|SUPERIORITY_OR_OTHER|||||||0.0227||95.0|||||Log Rank|||||||0.0227
71701785|NCT00217737|142920396|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.63|1.11|||||Hazard ratio: Arm B/Arm A|||1.11|0.63|
71701786|NCT04132050|142920400|SUPERIORITY||Difference in Percent of Participants|36.4||||0.03|TWO_SIDED|95.0|3.1|59.3|||Fisher Exact||"The difference in the achievement rate of Stable platelet response (= platelet count of ≥ 50000/μL at 4 or more of the 6 visits from Weeks 14 to 24) between two groups and its two-sided 95% CI were calculated."|||59.3|3.1|0.030
71701787|NCT00843882|142920415|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71701788|NCT00843882|142920424|SUPERIORITY|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
71701789|NCT05317546|142920428|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.33||||||alpha \< 0.05|Mixed Models Analysis|Adjusted for brain tissue composition||An a priori power analysis was conducted to ensure power to detect differences in neurometabolite levels in the dACC. Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.33
71701790|NCT05317546|142920429|SUPERIORITY|We used linear mixed effects models containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) with random intercepts. For 1H-MRS models, brain tissue composition \[Gray Matter: Brain Matter or GM:BM defined as GM/(GM+WM)\] was included as a covariate.||||||0.75||||||alpha \<0.05|Mixed Models Analysis|Adjusted for brain tissue composition||Due to type of modeling, participants were included even if they did not complete the second medication allocation.||||0.75
71701791|NCT05317546|142920430|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Several studies have demonstrated that CBD can modulate resting-state or task-based BOLD signal under similar study design (acute dosing, 600 mg CBD) with sample sizes smaller than our sample. Due to the modeling, only participants with usable data from both medication allocation visits were included. Contrast of interest was alcohol beverages vs. non-alcohol beverages.||||>0.05
71701792|NCT05317546|142920431|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.82
71701793|NCT05317546|142920432|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||We were not able to complete a power calculation for this task. We used linear mixed effects models, containing the main effect of medication (CBD vs. placebo), visit (visit 1 vs. visit 2), and sequence (CBD/placebo vs. placebo/CBD) and cue-by-medication interaction terms. Random intercepts were included to account for individual differences.||||0.21
71761964|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.014|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response in Burden domain||||||0.014
71823359|NCT01823341|143149819|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
71823360|NCT01823341|143149819|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
71886152|NCT00662792|143292978|SUPERIORITY||Difference of adjusted means|-0.065|STANDARD_ERROR_OF_MEAN|0.024||0.0074|TWO_SIDED|95.0|-0.113|-0.018|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.018|-0.113|0.0074
71641660|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.03|||<|0.001|TWO_SIDED|95.0|40.46|73.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes||73.60|40.46|<0.001
71701794|NCT04590963|142920437|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.989|TWO_SIDED|95.0|0.66|1.537|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.537|0.660|0.989
71701795|NCT04590963|142920438|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.704|1.528|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.528|0.704|0.891
71641661|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|72.66|||<|0.001|TWO_SIDED|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||87.84|57.48|<0.001
71701796|NCT04590963|142920439|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.574|TWO_SIDED|95.0|0.79|1.568|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.568|0.790|0.574
71701797|NCT04590963|142920440|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.53|TWO_SIDED|95.0|0.818|1.512|||Log Rank|P-value was calculated using stratified log-rank test, adjusted for HPV status, WHO/ECOG PS (0/1) and number of prior lines of therapy in R/M setting.|HR and CIs were calculated using a stratified Cox proportional hazards model, adjusted for HPV status, WHO/ECOG PS, and number of lines of prior therapy in R/M setting.|||1.512|0.818|0.530
71701798|NCT04590963|142920441|SUPERIORITY||Odds Ratio (OR)|0.56||||0.115|TWO_SIDED|95.0|0.274|1.154|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.154|0.274|0.115
71701799|NCT04590963|142920442|SUPERIORITY||Odds Ratio (OR)|0.6||||0.162|TWO_SIDED|95.0|0.297|1.231|||Regression, Logistic|P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|The analysis was performed using a logistic regression model, with treatment as a covariate and adjusting for HPV Status, WHO/ECOG PS, and number of lines of prior therapy in the R/M setting with 95% CI calculated by profile likelihood.|||1.231|0.297|0.162
71701800|NCT01063114|142920449|OTHER||3-Year Cumulative incidence|26.0|||||TWO_SIDED|95.0|16.0|37.0||||||||37|16|
71701801|NCT01063114|142920449|OTHER||5-Year Cumulative incidence|27.0|||||TWO_SIDED|95.0|17.0|38.0||||||||38|17|
71701802|NCT01063114|142920450|OTHER||3-Year Cumulative incidence|46.0|||||TWO_SIDED|95.0|34.0|57.0||||||||57|34|
71701803|NCT01063114|142920450|OTHER||5-Year Cumulative incidence|67.0|||||TWO_SIDED|95.0|54.0|77.0||||||||77|54|
71641662|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|81.2|||<|0.001|TWO_SIDED|95.0|67.91|94.49||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||94.49|67.91|<0.001
71701804|NCT01063114|142920451|OTHER||Mean Difference (Net)|-11.0||||0.01024|TWO_SIDED|95.0|-19.2|-2.9|||t-test, 2 sided|Paired t test||||-2.9|-19.2|0.01024
71701805|NCT01063114|142920452|OTHER||3-Year Survival Probability|83.2|||||TWO_SIDED|95.0|75.8|91.3||||||||91.3|75.8|
71701806|NCT01063114|142920452|OTHER||5-Year Survival Probability|79.6|||||TWO_SIDED|95.0|71.7|88.5||||||||88.5|71.7|
71701807|NCT03409367|142920502|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|0.84||||0.019|TWO_SIDED|95.0|0.73|0.97|||Regression, log-binomial||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|The null hypothesis is that the cumulative incidence of atopic dermatitis does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio is equal to 1.||0.97|0.73|0.019
71701808|NCT03409367|142920503|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.76||||0.002|TWO_SIDED|95.0|0.65|0.9|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of parent-reported AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.90|0.65|0.002
71701809|NCT03409367|142920504|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.86||||0.323|TWO_SIDED|95.0|0.65|1.15||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.|Regression, log-binomial|||The null hypothesis is that the cumulative incidence of AD by modified UK Working Party criteria does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.15|0.65|0.323
71701810|NCT03409367|142920505|EQUIVALENCE|Risk ratio is equal to 1.|Risk Ratio (RR)|0.83||||0.044|TWO_SIDED|95.0|0.7|0.99|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD by CEQ does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.99|0.70|0.044
71701811|NCT03409367|142920506|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.84|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations.||The null hypothesis is that the cumulative incidence of AD with prescription or OTC therapies in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.84|0.55|0.0004
71701812|NCT03409367|142920507|EQUIVALENCE|The odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of recommended treatment.|Odds Ratio (OR)|0.7||||0.004|TWO_SIDED|95.0|0.55|0.89||Adjusted for family history of atopy (stratified randomization) and primary care site. Adjusted for multiple imputations of 199 missing outcomes.|Regression, proportional odds|||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.89|0.55|0.004
71641663|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.84|||<|0.001|TWO_SIDED|95.0|42.34|75.35||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes||75.35|42.34|<0.001
71641664|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|69.33|||<|0.001|TWO_SIDED|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||85.33|53.33|<0.001
71641665|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|77.82|||<|0.001|TWO_SIDED|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||92.06|63.57|<0.001
71641666|NCT00913627|142802229|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.86|||<|0.001|TWO_SIDED|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes||75.84|41.88|<0.001
71641667|NCT00913627|142802230|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
71641668|NCT00913627|142802230|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.02||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.02|0.88|<0.001
71641669|NCT00913627|142802230|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.84|||<|0.001|TWO_SIDED|95.0|0.7|0.98||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.98|0.70|<0.001
71641670|NCT00913627|142802231|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|TWO_SIDED|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.85|<0.001
71641671|NCT00913627|142802231|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.96|||<|0.001|TWO_SIDED|95.0|0.91|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||1.01|0.91|<0.001
71641672|NCT00913627|142802231|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma Statistic|0.89|||<|0.001|TWO_SIDED|95.0|0.79|0.99||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||||0.99|0.79|<0.001
71641673|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.008
71641674|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.007|TWO_SIDED|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.38|0.06|0.007
71641675|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.024|TWO_SIDED|95.0|0.02|0.34||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.34|0.02|0.024
71641676|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||<|0.001|TWO_SIDED|95.0|0.24|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.78|0.24|<0.001
71641677|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|0.2|0.73||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.73|0.20|<0.001
71641678|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.002|TWO_SIDED|95.0|0.16|0.68||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.68|0.16|0.002
71641679|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.17||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.17|0.52|<0.001
71641680|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|||<|0.001|TWO_SIDED|95.0|0.47|1.11||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.11|0.47|<0.001
71641681|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.3|0.94||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||0.94|0.30|<0.001
71641682|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.65|1.37||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.37|0.65|<0.001
71641683|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|||<|0.001|TWO_SIDED|95.0|0.73|1.44||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.44|0.73|<0.001
71641684|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.54|1.25||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.25|0.54|<0.001
71641685|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.9|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.63|0.90|<0.001
71641686|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|||<|0.001|TWO_SIDED|95.0|0.97|1.69||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.69|0.97|<0.001
71641687|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.74|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||1.45|0.74|<0.001
71641688|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.001|TWO_SIDED|95.0|1.09|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.09|<0.001
71641689|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.82|1.10|<0.001
71641690|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.67|1.38||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||1.38|0.67|<0.001
71641691|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.00|1.26|<0.001
71641692|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.98|1.25|<0.001
71641693|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.85|1.57||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||1.57|0.85|<0.001
71641694|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.08|1.33|<0.001
71641695|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.97|1.23|<0.001
71701813|NCT03409367|142920508|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD, as operationalized here by the type of treatment.|Odds Ratio (OR)|0.72||||0.013|TWO_SIDED|95.0|0.56|0.93|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms.||0.93|0.56|0.013
71701814|NCT03409367|142920509|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.92||||0.509|TWO_SIDED|95.0|0.73|1.17|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of skin infections in the health record does not differ between the Daily Emollient and Natural Skin arms.||1.17|0.73|0.509
71701815|NCT03409367|142920510|EQUIVALENCE|The risk ratio is equal to 1.|Risk Ratio (RR)|1.05||||0.9|TWO_SIDED|95.0|0.5|2.18|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of asthma in the health record does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||2.18|0.50|0.900
71701816|NCT03409367|142920511|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.47||||0.064|TWO_SIDED|95.0|0.98|2.21|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|The daily emollient is in the numerator and the natural skin is in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.21|0.98|0.064
71701817|NCT03409367|142920512|EQUIVALENCE|An ordinal OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.62||||0.007|TWO_SIDED|95.0|1.14|2.3|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily emollient in the numerator and natural skin in the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.30|1.14|0.007
71701818|NCT03409367|142920513|EQUIVALENCE|The ordinal odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.45||||0.07|TWO_SIDED|95.0|0.97|2.18|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).|Daily moisturizer is the numerator and natural skin is the denominator.|The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the ordinal odds ratio (OR) is equal to 1.||2.18|0.97|0.070
71701819|NCT03409367|142920514|EQUIVALENCE|Odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.|Odds Ratio (OR)|1.36||||0.085|TWO_SIDED|95.0|0.96|1.91|||Regression, proportional odds|Adjusted for family history of atopy (stratified randomization).||The null hypothesis is that the odds of belonging to the next higher category of severity are equal in the Daily Emollient and Natural Skin arms, or that the odds ratio (OR) is equal to 1. An OR \< 1 could be considered evidence that daily emollient use is associated with lower severity of AD symptoms among those diagnosed with AD.||1.91|0.96|0.085
71701820|NCT03409367|142920515|EQUIVALENCE|The risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.75||||0.079|TWO_SIDED|95.0|0.55|1.03|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of immediate food allergy reactions does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.03|0.55|0.079
71701821|NCT03409367|142920516|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.66|||Regression, log-binomial|||The null hypothesis is that the cumulative incidence of food allergies does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.66|0.45|0.669
71701822|NCT03409367|142920517|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.77||||0.013|TWO_SIDED|95.0|0.62|0.95|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.95|0.62|0.013
71701823|NCT03409367|142920518|EQUIVALENCE|Risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.|Risk Ratio (RR)|0.8||||0.009|TWO_SIDED|95.0|0.67|0.94|||Regression, log-binomial|Adjusted for family history of atopy (stratified randomization) and primary care site.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1. Alternatively, a RR \< 1 could be considered evidence that daily emollient is associated with lower incidence of AD.||0.94|0.67|0.009
71701824|NCT03409367|142920519|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.77||||0.012|TWO_SIDED|95.0|0.63|0.94|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 121 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||0.94|0.63|0.012
71701825|NCT03409367|142920520|EQUIVALENCE|Risk ratio (RR) is equal to 1.|Risk Ratio (RR)|0.9||||0.303|TWO_SIDED|95.0|0.73|1.1|||Regression, log-binomial|Adjusted for primary care site. Adjusted for multiple imputations of 78 missing outcomes.||The null hypothesis is that the cumulative incidence of AD does not differ between the Daily Emollient and Natural Skin arms, or that the risk ratio (RR) is equal to 1.||1.10|0.73|0.303
71701826|NCT03824158|142920532|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
71701827|NCT03824158|142920533|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||||||0.76
71701828|NCT03824158|142920534|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71701829|NCT03824158|142920535|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
71701830|NCT03824158|142920536|SUPERIORITY|||||||0.002|||||||Chi-squared|||Advance directive or living will||||0.002
71701831|NCT03824158|142920536|SUPERIORITY|||||||0.02|||||||Fisher Exact|||POLST||||0.02
71701832|NCT03824158|142920536|SUPERIORITY|||||||0.78|||||||Chi-squared|||Code Status||||0.78
71701833|NCT03824158|142920536|SUPERIORITY|||||||0.61|||||||Chi-squared|||Goals of Care discussion||||0.61
71701834|NCT03824158|142920537|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71701835|NCT03824158|142920538|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71701836|NCT01260948|142920561|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.72|||||TWO_SIDED|90.0|94.13|103.53|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.53|94.13|
71701837|NCT01260948|142920562|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.81|||||TWO_SIDED|90.0|91.3|98.47|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.47|91.30|
71701838|NCT01525589|142920573|SUPERIORITY|||||||0.0909|||||||Log Rank|||||||0.0909
71701839|NCT01525589|142920577|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
71701840|NCT01525589|142920581|SUPERIORITY|||||||0.0561|||||||Log Rank|||||||0.0561
71701841|NCT03459846|142920624|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.789|TWO_SIDED|95.0|0.641|1.387|||Regression, Cox|||||1.387|0.641|0.789
71701842|NCT03459846|142920625|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.728|TWO_SIDED|95.0|0.719|1.606|||Regression, Cox|||||1.606|0.719|0.728
71701843|NCT03459846|142920626|SUPERIORITY||Odds Ratio (OR)|1.76||||0.142|TWO_SIDED|95.0|0.821|3.778|||Regression, Logistic|||||3.778|0.821|0.142
71701844|NCT02141113|142920638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These changed scores show the total change in ADHD symptoms over the course of the trial. Higher values indiicate improved functioning at the end of the trial compared to the beginning.||||.779
71701845|NCT02141113|142920639|SUPERIORITY|||||||0.834|||||||ANOVA|||||||.834
71701846|NCT02141113|142920640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.705|TWO_SIDED||||||ANOVA|||||||.705
71701847|NCT02141113|142920641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|TWO_SIDED||||||ANOVA|||||||.322
71701848|NCT02141113|142920642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
71701849|NCT02141113|142920643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|TWO_SIDED||||||ANOVA|||||||.212
71701850|NCT04253626|142920646|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||< 0.001
71701851|NCT04253626|142920650|OTHER|||||||0.88||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.88
71701852|NCT04253626|142920651|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|The a priori threshold for statistical significance was \< 0.05.||Between-group analysis of change at week 4||||0.27
71701853|NCT04253626|142920652|OTHER|||||||0.72||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.72
71701854|NCT04253626|142920653|OTHER|||||||0.009||||||The a priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||Between-group analysis of change at week 4||||0.009
71701855|NCT05763875|142920654|SUPERIORITY||LS Mean Difference|-35.37|||<|0.0001|TWO_SIDED|95.0|-40.88|-29.86|||ANCOVA|||Treatment Policy Estimand||-29.86|-40.88|<0.0001
71701856|NCT05763875|142920654|SUPERIORITY||LS Mean Difference|-47.91|||<|0.0001|TWO_SIDED|95.0|-53.62|-42.2|||ANCOVA|||Treatment Policy Estimand||-42.20|-53.62|<0.0001
71701857|NCT05763875|142920654|SUPERIORITY||LS Mean Difference|-37.44|||<|0.0001|TWO_SIDED|95.0|-42.63|-32.26|||ANCOVA|||Monotherapy Estimand||-32.26|-42.63|<0.0001
71701858|NCT05763875|142920654|SUPERIORITY||LS Mean Difference|-50.9|||<|0.0001|TWO_SIDED|95.0|-56.51|-45.28|||ANCOVA|||Monotherapy Estimand||-45.28|-56.51|<0.0001
71701859|NCT05763875|142920655|SUPERIORITY||LS Mean Difference|-47.37|||<|0.0001|TWO_SIDED|95.0|-53.91|-40.72|||ANCOVA|||Treatment Policy Estimand||-40.72|-53.91|<0.0001
71701860|NCT05763875|142920655|SUPERIORITY||LS Mean Difference|-63.57|||<|0.0001|TWO_SIDED|95.0|-70.28|-56.87|||ANCOVA|||Treatment Policy Estimand||-56.87|-70.28|<0.0001
71701861|NCT05763875|142920655|SUPERIORITY||LS Mean Difference|-50.05|||<|0.0001|TWO_SIDED|95.0|-56.16|-43.94|||ANCOVA|||Monotherapy Estimand||-43.94|-56.16|<0.0001
71701862|NCT05763875|142920655|SUPERIORITY||LS Mean Difference|-67.51|||<|0.0001|TWO_SIDED|95.0|-74.09|-60.92|||ANCOVA|||Monotherapy Estimand||-60.92|-74.09|<0.0001
71701863|NCT05763875|142920656|SUPERIORITY||LS Mean Difference|-73.16|||<|0.0001|TWO_SIDED|95.0|-81.76|-64.56|||ANCOVA|||Treatment Policy Estimand||-64.56|-81.76|<0.0001
71701864|NCT05763875|142920656|SUPERIORITY||LS Mean Difference|-74.94|||<|0.0001|TWO_SIDED|95.0|-84.51|-65.37|||ANCOVA|||Treatment Policy Estimand||-65.37|-84.51|<0.0001
71701865|NCT05763875|142920656|SUPERIORITY||LS Mean Difference|-76.87|||<|0.0001|TWO_SIDED|95.0|-85.12|-68.62|||ANCOVA|||Monotherapy Estimand||-68.62|-85.12|<0.0001
71701866|NCT05763875|142920656|SUPERIORITY||LS Mean Difference|-79.47|||<|0.0001|TWO_SIDED|95.0|-88.77|-70.17|||ANCOVA|||Monotherapy Estimand||-70.17|-88.77|<0.0001
71701867|NCT05763875|142920657|SUPERIORITY||LS Mean Difference|-30.48|||<|0.0001|TWO_SIDED|95.0|-34.98|-25.98|||ANCOVA|||Treatment Policy Estimand||-25.98|-34.98|<0.0001
71701868|NCT05763875|142920657|SUPERIORITY||LS Mean Difference|-42.32|||<|0.0001|TWO_SIDED|95.0|-47.83|-36.82|||ANCOVA|||Treatment Policy Estimand||-36.82|-47.83|<0.0001
71701869|NCT05763875|142920657|SUPERIORITY||LS Mean Difference|-31.98|||<|0.0001|TWO_SIDED|95.0|-36.07|-27.89|||ANCOVA|||Monotherapy Estimand||-27.89|-36.07|<0.0001
71701870|NCT05763875|142920657|SUPERIORITY||LS Mean Difference|-44.86|||<|0.0001|TWO_SIDED|95.0|-50.28|-39.44|||ANCOVA|||Monotherapy Estimand||-39.44|-50.28|<0.0001
71701871|NCT05763875|142920658|SUPERIORITY||LS Mean Difference|-24.84|||<|0.0001|TWO_SIDED|95.0|-30.32|-19.36|||ANCOVA|||Treatment Policy Estimand||-19.36|-30.32|<0.0001
71701872|NCT05763875|142920658|SUPERIORITY||LS Mean Difference|-33.85|||<|0.0001|TWO_SIDED|95.0|-41.27|-26.44|||ANCOVA|||Treatment Policy Estimand||-26.44|-41.27|<0.0001
71701873|NCT05763875|142920658|SUPERIORITY||LS Mean Difference|-26.58|||<|0.0001|TWO_SIDED|95.0|-32.07|-21.09|||ANCOVA|||Monotherapy Estimand||-21.09|-32.07|<0.0001
71701874|NCT05763875|142920658|SUPERIORITY||LS Mean Difference|-36.06|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.67|||ANCOVA|||Monotherapy Estimand||-28.67|-43.46|<0.0001
71701875|NCT05763875|142920659|SUPERIORITY||LS Mean Difference|-28.98|||<|0.0001|TWO_SIDED|95.0|-33.3|-24.65|||ANCOVA|||Treatment Policy Estimand||-24.65|-33.30|<0.0001
71701876|NCT05763875|142920659|SUPERIORITY||LS Mean Difference|-36.66|||<|0.0001|TWO_SIDED|95.0|-41.1|-32.22|||ANCOVA|||Treatment Policy Estimand||-32.22|-41.10|<0.0001
71701877|NCT05763875|142920659|SUPERIORITY||LS Mean Difference|-30.16|||<|0.0001|TWO_SIDED|95.0|-34.08|-26.23|||ANCOVA|||Monotherapy Estimand||-26.23|-34.08|<0.0001
71701878|NCT05763875|142920659|SUPERIORITY||LS Mean Difference|-38.78|||<|0.0001|TWO_SIDED|95.0|-43.12|-34.43|||ANCOVA|||Monotherapy Estimand||-34.43|-43.12|<0.0001
71701879|NCT05763875|142920660|SUPERIORITY||LS Mean Difference|-30.24|||<|0.0001|TWO_SIDED|95.0|-36.92|-23.57|||ANCOVA|||Treatment Policy Estimand||-23.57|-36.92|<0.0001
71701880|NCT05763875|142920660|SUPERIORITY||LS Mean Difference|-35.15|||<|0.0001|TWO_SIDED|95.0|-41.18|-29.12|||ANCOVA|||Treatment Policy Estimand||-29.12|-41.18|<0.0001
71701881|NCT05763875|142920660|SUPERIORITY||LS Mean Difference|-32.34|||<|0.0001|TWO_SIDED|95.0|-39.1|-25.59|||ANCOVA|||Monotherapy Estimand||-25.59|-39.10|<0.0001
71701882|NCT05763875|142920660|SUPERIORITY||LS Mean Difference|-37.38|||<|0.0001|TWO_SIDED|95.0|-43.44|-31.31|||ANCOVA|||Monotherapy Estimand||-31.31|-43.44|<0.0001
71701883|NCT05763875|142920661|SUPERIORITY||Ratio of Geometric Mean|0.757||||0.0002|TWO_SIDED|95.0|0.65|0.882|||ANCOVA|||Treatment Policy Estimand||0.882|0.650|0.0002
71701884|NCT05763875|142920661|SUPERIORITY||Ratio of Geometric Mean|0.748||||0.001|TWO_SIDED|95.0|0.622|0.898|||ANCOVA|||Treatment Policy Estimand||0.898|0.622|0.0010
71701885|NCT05763875|142920661|SUPERIORITY||Ratio of Geometric Mean|0.753|||<|0.0001|TWO_SIDED|95.0|0.652|0.871|||ANCOVA|||Monotherapy Estimand||0.871|0.652|<0.0001
71701886|NCT05763875|142920661|SUPERIORITY||Ratio of Geometric Mean|0.746||||0.0008|TWO_SIDED|95.0|0.622|0.893|||ANCOVA|||Monotherapy Estimand||0.893|0.622|0.0008
71701887|NCT02266576|142920663|OTHER|||||||0.04||||||The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.|Regression, Linear|||Baseline vs month 6||||0.04
71701888|NCT02266576|142920663|OTHER|||||||0.02|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12||||0.02
71701889|NCT02266576|142920664|OTHER|||||||0.004|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 6 in physical component score||||0.004
71701890|NCT02266576|142920664|OTHER|||||||0.01|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12 in physical component score||||0.01
71701891|NCT03488524|142920731|SUPERIORITY||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.87||0.0239|TWO_SIDED|95.0|0.56|7.9||Significance testing was 2-tailed and considered statistically significant if the calculated p-value was ≤0.05.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope.||Participants who did not enter the open-label extension (OLE) were included in this analysis.||7.90|0.56|0.0239
71701892|NCT03488524|142920732|SUPERIORITY||Hazard Ratio (HR)|0.644||||0.0475|TWO_SIDED|95.0|0.416|0.995|||Hazard ratio|||Cox Proportional Hazards analysis||0.995|0.416|0.0475
71701893|NCT03488524|142920733|SUPERIORITY||Hazard Ratio (HR)|0.621||||0.0308|TWO_SIDED|95.0|0.403|0.957|||Hazard Ratio|||||0.957|0.403|0.0308
71701894|NCT03488524|142920734|SUPERIORITY||Mean Difference (Final Values)|7.77|STANDARD_ERROR_OF_MEAN|3.55||0.0291|TWO_SIDED|95.0|0.8|14.75|||Mixed Models Analysis|||||14.75|0.80|0.0291
71701895|NCT03488524|142920735|SUPERIORITY||Mean Difference (Final Values)|4.76|STANDARD_ERROR_OF_MEAN|3.923||0.2261|TWO_SIDED|95.0|-2.95|12.47|||Mixed Models Analysis|||||12.47|-2.95|0.2261
71701896|NCT03488524|142920736|SUPERIORITY||Mean Difference (Final Values)|10.66|STANDARD_ERROR_OF_MEAN|5.103||0.0372|TWO_SIDED|95.0|0.63|20.69||Nominal p-value|Mixed Models Analysis|||||20.69|0.63|0.0372
71701897|NCT03488524|142920737|SUPERIORITY|||||||0.0503||||||Nominal p-value|Mixed Models Analysis|||||||0.0503
71701898|NCT03279458|142920758|OTHER|least square regression analysis|correlation coefficient (R)|0.94|||<|0.05|TWO_SIDED|95.0|0.88|0.97|||Regression, Linear|||||0.97|0.88|<0.05
71701899|NCT01913353|142920759|NON_INFERIORITY|The non-inferiority margin to show that Group 1 (after 2 doses of MVA-BN) is non-inferior to Group 2 (after 1 dose of ACAM2000) in terms of PRNT GMTs at the respective peak visit (Week 6 in Group 1 / Week 4 in Group 2) was predefined as '1/2 (i.e. 0.5)' for the GMT ratio (Group 1 / Group 2).|GMT Ratio (Group 1 / Group 2)|1.935|||||TWO_SIDED|95.0|1.562|2.397||||||||2.397|1.562|
71701900|NCT01913353|142920760|SUPERIORITY|Predefined threshold of clinical relevance for the area attenuation ratio (AAR): 40%|Area attenuation ratio (AAR)|97.9|||||TWO_SIDED|95.0|96.6|98.3|||||The AAR, i.e. the reduction in MLA \[1 - MLA ratio (Group 1/Group 2)\] after scarification was to be significantly above 40%. The MLA ratio and the corresponding 95% CI were based on the Hodges-Lehmann estimate of the shift for log-transformed MLAs.|||98.3|96.6|
71701901|NCT01147458|142920791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
71701902|NCT01147458|142920791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
71761965|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.022|||||||Plum Ordinal Regression test|EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain||||||0.022
71701903|NCT01147458|142920792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.374||0.067|TWO_SIDED|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.04|0.08|0.067
71701904|NCT01147458|142920792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.369||0.701|TWO_SIDED|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.28|-0.67|0.701
71701905|NCT01147458|142920793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|80.0|-0.15|0.29|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.29|-0.15|
71701906|NCT01147458|142920793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|80.0|-0.09|0.35|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.35|-0.09|
71701907|NCT01147458|142920794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|1.239|||TWO_SIDED|80.0|-0.34|2.85|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||2.85|-0.34|
71701908|NCT01147458|142920794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.252|||TWO_SIDED|80.0|-1.95|1.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.28|-1.95|
71701909|NCT01147458|142920795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.06|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|80.0|-0.13|4.25|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||4.25|-0.13|
71701910|NCT01147458|142920795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|80.0|-2.53|1.88|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.88|-2.53|
71701911|NCT01147458|142920796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|0.624|||TWO_SIDED|80.0|-0.03|1.58|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||1.58|-0.03|
71701912|NCT01147458|142920796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|80.0|-0.97|0.65|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.65|-0.97|
71701913|NCT01147458|142920797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|80.0|-0.18|0.2|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.20|-0.18|
71701914|NCT01147458|142920797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|80.0|-0.07|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.07|
71701915|NCT01147458|142920798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|80.0|-0.12|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.12|
71701916|NCT01147458|142920798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|80.0|-0.11|0.31|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.||0.31|-0.11|
71701917|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.101|TWO_SIDED|95.0|0.4|1.09|||Log Rank|||Statistical analysis for primary efficacy composite endpoint.||1.09|0.40|= 0.101
71701918|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|1.12|||=|0.814|TWO_SIDED|95.0|0.43|2.91|||Log Rank|||Statistical analysis for Symptomatic lower extremity proximal DVT.||2.91|0.43|= 0.814
71701919|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|0.4|||=|0.26|TWO_SIDED|95.0|0.08|2.07|||Log Rank|||Statistical analysis for symptomatic lower extremity distal DVT.||2.07|0.08|= 0.260
71701920|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|0.67|||=|0.538|TWO_SIDED|95.0|0.19|2.39|||Log Rank|||Statistical analysis for symptomatic upper extremity DVT.||2.39|0.19|= 0.538
71701921|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|1.02|||=|0.977|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||Statistical analysis for symptomatic non-fatal PE.||3.52|0.29|= 0.977
71701922|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.063|TWO_SIDED|95.0|0.11|1.11|||Log Rank|||Statistical analysis for asymptomatic lower extremity proximal DVT.||1.11|0.11|= 0.063
71701923|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.301|TWO_SIDED|95.0|0.21|1.62|||Log Rank|||Statistical analysis for incidental PE.||1.62|0.21|= 0.301
71701924|NCT02555878|142920805|SUPERIORITY||Hazard Ratio (HR)|0.33|||=|0.314|TWO_SIDED|95.0|0.03|3.18|||Log Rank|||Statistical analysis for VTE-related death.||3.18|0.03|= 0.314
71701925|NCT02555878|142920806|SUPERIORITY||Hazard Ratio (HR)|1.96|||=|0.265|TWO_SIDED|95.0|0.59|6.49|||Log Rank|||||6.49|0.59|= 0.265
71701926|NCT00768053|142920836|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||F test for H0: ICC = 0|F test|||Intraclass correlation coefficient (ICC)||||0.000
71701927|NCT00768053|142920836|SUPERIORITY_OR_OTHER||standard error of measurement|0.65|||||TWO_SIDED|95.0|0.57|0.75||||||Standardized response mean: standard error of measurement||0.75|0.57|
71701928|NCT00768053|142920838|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
71701929|NCT00768053|142920839|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
71641696|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.001|TWO_SIDED|95.0|0.81|1.54||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||1.54|0.81|<0.001
71641697|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.00|1.20|<0.001
71641698|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|1.19|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.98|1.19|<0.001
71641699|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.73|1.52||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||1.52|0.73|<0.001
71641700|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|||<|0.001|TWO_SIDED|95.0|1.08|1.9||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.90|1.08|<0.001
71641701|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.97|1.16|<0.001
71641702|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||1.53|0.72|<0.001
71641703|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.97|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.79|0.97|<0.001
71641704|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55|||<|0.001|TWO_SIDED|95.0|1.14|1.95||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.95|1.14|<0.001
71641705|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED|95.0|0.62|1.43||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||1.43|0.62|<0.001
71641706|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001|TWO_SIDED|95.0|0.93|1.77||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.77|0.93|<0.001
71641707|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.81|0.97|<0.001
71641708|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.63|1.46||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||1.46|0.63|<0.001
71641709|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||<|0.001|TWO_SIDED|95.0|0.87|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.71|0.87|<0.001
71641710|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.81|0.97|<0.001
71641711|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.001|TWO_SIDED|95.0|0.56|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||1.39|0.56|<0.001
71641712|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.82|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.68|0.82|<0.001
71641713|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|||<|0.001|TWO_SIDED|95.0|1.03|1.89||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.89|1.03|<0.001
71641714|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.6|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||1.45|0.60|<0.001
71641715|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.64|0.77|<0.001
71641716|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|1.0|1.87||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.87|1.00|<0.001
71641717|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||1.48|0.61|<0.001
71641718|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.81|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.68|0.81|<0.001
71641719|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.96|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.82|0.96|<0.001
71641720|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.53|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||1.39|0.53|<0.001
71641721|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.75|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.64|0.75|<0.001
71641722|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||<|0.001|TWO_SIDED|95.0|0.77|1.65||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.65|0.77|<0.001
71641723|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|||<|0.001|TWO_SIDED|95.0|0.49|1.36||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||1.36|0.49|<0.001
71641724|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||<|0.001|TWO_SIDED|95.0|0.6|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.53|0.60|<0.001
71641725|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.58|0.66|<0.001
71641726|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||1.33|0.42|<0.001
71641727|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.51|0.61|<0.001
71641728|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||<|0.001|TWO_SIDED|95.0|0.58|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.48|0.58|<0.001
71701930|NCT00768053|142920840|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
71701931|NCT00768053|142920841|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 4||||<0.001
71701932|NCT00768053|142920842|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Week 12||||<0.001
71701933|NCT00768053|142920843|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test for the Pearson correlation|||Time-normalized average||||<0.001
71701934|NCT00768053|142920844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
71701935|NCT00768053|142920844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||<0.001
71701936|NCT00768053|142920844|SUPERIORITY_OR_OTHER|||||||0.837|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.837
71701937|NCT00768053|142920844|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.035
71701938|NCT00768053|142920844|SUPERIORITY_OR_OTHER|||||||0.351|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.351
71701939|NCT00768053|142920844|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.025
71701940|NCT00768053|142920844|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
71641729|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||<|0.001|TWO_SIDED|95.0|0.52|1.4||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||1.40|0.52|<0.001
71701941|NCT00768053|142920845|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value||||<0.001
71701942|NCT00768053|142920845|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value||||0.052
71641730|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.001|TWO_SIDED|95.0|0.31|1.24||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.24|0.31|0.001
71641731|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.001|TWO_SIDED|95.0|0.36|1.28||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.28|0.36|<0.001
71641732|NCT00913627|142802232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.33|0.42|<0.001
71641733|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.034|TWO_SIDED|95.0|0.02|0.57||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.57|0.02|0.034
71641734|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.111|TWO_SIDED|95.0|-0.05|0.49||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.49|-0.05|0.111
71641735|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.125|TWO_SIDED|95.0|-0.06|0.48||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.48|-0.06|0.125
71641736|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.22|0.41|<0.001
71641737|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.003|TWO_SIDED|95.0|0.22|1.01||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.01|0.22|0.003
71641738|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.004|TWO_SIDED|95.0|0.19|0.98||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||0.98|0.19|0.004
71641739|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41|||<|0.001|TWO_SIDED|95.0|0.91|1.91||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.91|0.91|<0.001
71641740|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.001|TWO_SIDED|95.0|0.75|1.74||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.74|0.75|<0.001
71641741|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.41|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||1.39|0.41|<0.001
71641742|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.11|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.16|1.11|<0.001
71641743|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.05|2.09||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||2.09|1.05|<0.001
71641744|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||<|0.001|TWO_SIDED|95.0|0.75|1.78||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||1.78|0.75|<0.001
71641745|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|||<|0.001|TWO_SIDED|95.0|1.46|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.52|1.46|<0.001
71641746|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.61||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.61|1.57|<0.001
71701943|NCT00768053|142920845|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value||||0.895
71701944|NCT00768053|142920845|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value||||0.153
71701945|NCT00768053|142920845|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value||||0.029
71701946|NCT00768053|142920845|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value||||0.043
71701947|NCT00768053|142920845|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value||||<0.001
71701948|NCT01164475|142920862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.395|TWO_SIDED|95.0|0.44|9.17|||Regression, Logistic|||The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.||9.17|0.44|0.395
71701949|NCT04603066|142920875|SUPERIORITY||Mean Difference (Final Values)|0.0204257||||0.8651|TWO_SIDED|95.0|-0.2624635|0.2216122|||t-test, 2 sided|||||0.2216122|-0.2624635|0.8651
71701950|NCT04603066|142920876|SUPERIORITY||Mean Difference (Net)|0.01727052||||0.056|TWO_SIDED|95.0|-0.0005895|0.03513063|||t-test, 2 sided|||||0.03513063|-0.0005895|0.056
71701951|NCT03244189|142920933|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||||1.20|0.77|
71701952|NCT03244189|142920934|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.37||||||||1.37|0.72|
71701953|NCT03244189|142920935|OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.91|2.29||||||||2.29|0.91|
71823361|NCT00924560|143149820|NON_INFERIORITY_OR_EQUIVALENCE|91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.67|0.2|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.20|-0.67|
71701954|NCT00884065|142921018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|4.08|>|0.05|TWO_SIDED|95.0|-9.93|6.49|||t-test, 2 sided|||||6.49|-9.93|>0.05
71701955|NCT00884065|142921019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.01||95.0|5.72|17.08|||t-test, 2 sided|||||17.08|5.72|<0.01
71701956|NCT00884065|142921020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.24|STANDARD_ERROR_OF_MEAN|2.59|<|0.01|TWO_SIDED|95.0|2.03|12.45|||t-test, 2 sided|||||12.45|2.03|<0.01
71701957|NCT00884065|142921021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.72|>|0.05|TWO_SIDED|95.0|-1.53|5.37|||t-test, 2 sided|||||5.37|-1.53|>0.05
71701958|NCT00884065|142921022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.18|>|0.05|TWO_SIDED|95.0|-3.81|5.01|||t-test, 2 sided|||||5.01|-3.81|>0.05
71701959|NCT00884065|142921023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.08|STANDARD_ERROR_OF_MEAN|1.49|<|0.01|TWO_SIDED|95.0|0.08|6.09|||t-test, 2 sided|||||6.09|0.08|<0.01
71701960|NCT04937387|142921092|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0449|||TWO_SIDED|95.0|-0.03|0.147|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.147|-0.030|
71701961|NCT04937387|142921092|OTHER||Posterior Mean|0.076|||||TWO_SIDED|90.0|0.025|0.115|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.115|0.025|
71701962|NCT04937387|142921092|OTHER||Posterior Median|0.079|||||TWO_SIDED|95.0|0.005|0.123|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 100/62.5/25 and FF/VI 100/25 estimated in the MMRM analysis.|||0.123|0.005|
71701963|NCT04937387|142921093|OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0455|||TWO_SIDED|95.0|-0.094|0.084|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline trough FEV1 value, visit, and interaction terms for baseline trough FEV1-by-visit and treatment-by-visit, covariance structure = unstructured.|0.084|-0.094|
71701964|NCT04937387|142921093|OTHER||Posterior Mean|0.023|||||TWO_SIDED|90.0|-0.071|0.103|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.103|-0.071|
71701965|NCT04937387|142921093|OTHER||Posterior Median|0.023||||||95.0|-0.086|0.11|||||Analysis was conducted in the Bayesian paradigm using the pre-specified mixture prior distribution, which was updated with the treatment difference between FF/UMEC/VI 200/62.5/25 and FF/VI 200/25 estimated in the MMRM analysis.|||0.110|-0.086|
71701966|NCT04937387|142921094|OTHER||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0823|||TWO_SIDED|95.0|-0.19|0.134|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.134|-0.190|
71761966|NCT00856518|143025871|SUPERIORITY_OR_OTHER||||||>|0.05||||||Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains.|Wilcoxon Signed Ranks Test|||||||>0.05
71701967|NCT04937387|142921094|OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.052|0.276|||||||Analysis performed using mixed effect model for repeated measures with covariates of treatment, age, sex, eCRF-reported pre-study ICS dosage at screening (med, high), baseline ACQ-7 total score, visit, and interaction terms for baseline ACQ-7 total score-by-visit and treatment-by-visit, covariance structure = unstructured.|0.276|-0.052|
71701968|NCT04950686|142921095|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.983|TWO_SIDED||||||Mixed Models Analysis|||||||0.983
71701969|NCT04950686|142921095|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.465|TWO_SIDED||||||Mixed Models Analysis|||||||0.465
71701970|NCT04950686|142921096|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
71701971|NCT04950686|142921096|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.536|TWO_SIDED||||||Mixed Models Analysis|||||||0.536
71701972|NCT04950686|142921097|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.745|TWO_SIDED||||||Mixed Models Analysis|||||||0.745
71701973|NCT04950686|142921097|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.14||0.972|TWO_SIDED||||||Mixed Models Analysis|||||||0.972
71701974|NCT04950686|142921098|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.12||||0.682|TWO_SIDED|95.0|0.24|5.25|||Mixed Models Analysis|||||5.25|0.24|0.682
71701975|NCT04950686|142921098|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15||||0.63|TWO_SIDED|95.0|0.28|4.69|||Mixed Models Analysis|||||4.69|0.28|0.630
71701976|NCT04950686|142921099|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.418|TWO_SIDED|95.0|0.12|12.82|||Mixed Models Analysis|||||12.82|0.12|0.418
71701977|NCT04950686|142921099|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.194|TWO_SIDED|95.0|0.13|17.29|||Mixed Models Analysis|||||17.29|0.13|0.194
71701978|NCT04950686|142921100|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.731|TWO_SIDED|95.0|0.1|8.07|||Mixed Models Analysis|||||8.07|0.10|0.731
71701979|NCT04950686|142921100|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.786|TWO_SIDED|95.0|0.16|7.34|||Mixed Models Analysis|||||7.34|0.16|0.786
71701980|NCT04950686|142921101|SUPERIORITY|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.11||||0.71|TWO_SIDED|95.0|0.16|7.49|||Mixed Models Analysis|||||7.49|0.16|0.710
71701981|NCT04950686|142921101|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.16||||0.61|TWO_SIDED|95.0|0.16|8.73|||Mixed Models Analysis|||||8.73|0.16|0.610
71701982|NCT04950686|142921102|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.37||||0.27|TWO_SIDED|95.0|0.09|20.33|||Mixed Models Analysis|||||20.33|.09|0.270
71701983|NCT04950686|142921102|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.465|TWO_SIDED|95.0|0.08|18.57|||Mixed Models Analysis|||||18.57|0.08|0.465
71761967|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Burden domain||||||0.038
71701984|NCT04950686|142921103|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.91||||0.702|TWO_SIDED|95.0|0.07|11.95|||Mixed Models Analysis|||||11.95|0.07|0.702
71701985|NCT04950686|142921103|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.21||||0.538|TWO_SIDED|95.0|0.19|7.56|||Mixed Models Analysis|||||7.56|0.19|0.538
71701986|NCT04950686|142921104|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.084|TWO_SIDED||||||Mixed Models Analysis|||||||0.084
71701987|NCT04950686|142921104|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
71701988|NCT04950686|142921105|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.614|TWO_SIDED||||||Mixed Models Analysis|||||||0.614
71701989|NCT04950686|142921105|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.854|TWO_SIDED||||||Mixed Models Analysis|||||||0.854
71701990|NCT04950686|142921106|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.499|TWO_SIDED||||||Mixed Models Analysis|||||||0.499
71701991|NCT04950686|142921106|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.623|TWO_SIDED||||||Mixed Models Analysis|||||||0.623
71701992|NCT04950686|142921107|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.84||||0.618|TWO_SIDED|95.0|0.14|5.15|||Mixed Models Analysis|||||5.15|0.14|0.618
71701993|NCT04950686|142921107|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.19||||0.626|TWO_SIDED|95.0|0.1|14.13|||Mixed Models Analysis|||||14.13|0.10|0.626
71701994|NCT04950686|142921108|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.47||||0.232|TWO_SIDED|95.0|0.23|9.18|||Mixed Models Analysis|||||9.18|0.23|.232
71701995|NCT04950686|142921108|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08||||0.811|TWO_SIDED|95.0|0.22|5.38|||Mixed Models Analysis|||||5.38|0.22|0.811
71701996|NCT04950686|142921109|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.26||||0.427|TWO_SIDED|95.0|0.16|9.94|||Mixed Models Analysis|||||9.94|0.16|0.427
71701997|NCT04950686|142921109|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.39||||0.337|TWO_SIDED|95.0|0.25|7.68|||Mixed Models Analysis|||||7.68|0.25|0.337
71701998|NCT04950686|142921110|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.11||0.419|TWO_SIDED||||||Mixed Models Analysis|||||||0.419
71701999|NCT04950686|142921110|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.808|TWO_SIDED||||||Mixed Models Analysis|||||||0.808
71702000|NCT04950686|142921111|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.12||0.616|TWO_SIDED||||||Mixed Models Analysis|||||||0.616
71761968|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Mental Health domain||||||0.031
71702001|NCT04950686|142921111|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.12||0.486|TWO_SIDED||||||Mixed Models Analysis|||||||0.486
71702002|NCT04950686|142921112|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
71702003|NCT04950686|142921112|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.226|TWO_SIDED||||||Mixed Models Analysis|||||||0.226
71702004|NCT04950686|142921113|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.630
71702005|NCT04950686|142921113|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.880
71702006|NCT04950686|142921114|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
71702007|NCT04950686|142921114|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.12||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.980
71702008|NCT04950686|142921115|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
71702009|NCT04950686|142921115|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.13||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.990
71702010|NCT04950686|142921116|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.14||0.989|TWO_SIDED||||||Mixed Models Analysis|||||||0.989
71702011|NCT04950686|142921116|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.678|TWO_SIDED||||||Mixed Models Analysis|||||||0.678
71702012|NCT04950686|142921117|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
71702013|NCT04950686|142921117|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.15||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||0.024
71702014|NCT04950686|142921118|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.301|TWO_SIDED||||||Mixed Models Analysis|||||||0.301
71702015|NCT04950686|142921118|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.17||0.702|TWO_SIDED||||||Mixed Models Analysis|||||||0.702
71702016|NCT04950686|142921119|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.76||||0.352|TWO_SIDED|95.0|0.1|6.13|||Mixed Models Analysis|||||6.13|0.10|0.352
71702017|NCT04950686|142921119|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.82||||0.445|TWO_SIDED|95.0|0.11|6.16|||Mixed Models Analysis|||||6.16|0.11|0.445
71761969|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.027|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Burden domain||||||0.027
71702018|NCT04950686|142921120|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.55||||0.039|TWO_SIDED|95.0|0.12|2.6|||Mixed Models Analysis|||||2.60|0.12|0.039
71702019|NCT04950686|142921120|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.59||||0.073|TWO_SIDED|95.0|0.17|2.12|||Mixed Models Analysis|||||2.12|0.17|0.073
71702020|NCT04950686|142921121|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.62||||0.11|TWO_SIDED|95.0|0.13|2.93|||Mixed Models Analysis|||||2.93|0.13|0.110
71702021|NCT04950686|142921121|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.65||||0.174|TWO_SIDED|95.0|0.11|3.78|||Mixed Models Analysis|||||3.78|0.11|0.174
71702022|NCT04950686|142921122|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.31||0.208|TWO_SIDED||||||Mixed Models Analysis|||||||0.208
71702023|NCT04950686|142921122|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.302|TWO_SIDED||||||Mixed Models Analysis|||||||0.302
71702024|NCT04950686|142921123|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.483|TWO_SIDED||||||Mixed Models Analysis|||||||0.483
71702025|NCT04950686|142921123|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.3||0.933|TWO_SIDED||||||Mixed Models Analysis|||||||0.933
71702026|NCT04950686|142921124|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.32||0.877|TWO_SIDED||||||Mixed Models Analysis|||||||0.877
71641747|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|1.16|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||2.20|1.16|<0.001
71702027|NCT04950686|142921124|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.32||0.418|TWO_SIDED||||||Mixed Models Analysis|||||||0.418
71702028|NCT04950686|142921125|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|2.23||||0.22|TWO_SIDED|95.0|0.05|98.76|||Mixed Models Analysis|||||98.76|0.05|0.220
71702029|NCT04950686|142921125|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.1|11.3||||||||11.30|0.10|
71702030|NCT04950686|142921126|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.48||||0.506|TWO_SIDED|95.0|0.03|63.29|||Mixed Models Analysis|||||63.29|0.03|0.506
71702031|NCT04950686|142921126|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.04|36.32||||||||36.32|0.04|
71702032|NCT04950686|142921127|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.09||||0.877|TWO_SIDED|95.0|0.04|28.37|||Mixed Models Analysis|||||28.37|0.04|0.877
71761970|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Mental Health domain||||||0.016
71641748|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.59|2.64||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.64|1.59|<0.001
71641749|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.7|2.74||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.74|1.70|<0.001
71641750|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||<|0.001|TWO_SIDED|95.0|1.18|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||2.21|1.18|<0.001
71702033|NCT04950686|142921127|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.02|26.92||||||||26.92|0.02|
71702034|NCT04950686|142921128|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.005|TWO_SIDED||||||Mixed Models Analysis|||||||0.005
71702035|NCT04950686|142921128|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.05||1e-05|TWO_SIDED||||||Mixed Models Analysis|||||||0.00001
71702036|NCT04950686|142921129|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.314|TWO_SIDED||||||Mixed Models Analysis|||||||0.314
71702037|NCT04950686|142921129|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.176|TWO_SIDED||||||Mixed Models Analysis|||||||0.176
71702038|NCT04950686|142921130|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
71702039|NCT04950686|142921130|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
71702040|NCT04950686|142921131|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.132|TWO_SIDED||||||Mixed Models Analysis|||||||0.132
71702041|NCT04950686|142921131|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.008|TWO_SIDED||||||Mixed Models Analysis|||||||0.008
71702042|NCT04950686|142921132|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.941|TWO_SIDED||||||Mixed Models Analysis|||||||0.941
71702043|NCT04950686|142921132|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.569|TWO_SIDED||||||Mixed Models Analysis|||||||0.569
71702044|NCT04950686|142921133|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.354|TWO_SIDED||||||Mixed Models Analysis|||||||0.354
71702045|NCT04950686|142921133|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED||||||Mixed Models Analysis|||||||0.038
71702046|NCT04950686|142921134|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.501|TWO_SIDED||||||Mixed Models Analysis|||||||0.501
71702047|NCT04950686|142921134|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.385|TWO_SIDED||||||Mixed Models Analysis|||||||0.385
71641751|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.98|3.01||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.01|1.98|<0.001
71641752|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||<|0.001|TWO_SIDED|95.0|1.97|2.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.99|1.97|<0.001
71641753|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.38||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||2.38|1.37|<0.001
71641754|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54|||<|0.001|TWO_SIDED|95.0|2.01|3.07||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.07|2.01|<0.001
71641755|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.92|2.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.97|1.92|<0.001
71702048|NCT04950686|142921135|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.095|TWO_SIDED||||||Mixed Models Analysis|||||||0.095
71702049|NCT04950686|142921135|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.349|TWO_SIDED||||||Mixed Models Analysis|||||||0.349
71702050|NCT04950686|142921136|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
71702051|NCT04950686|142921136|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.103|TWO_SIDED||||||Mixed Models Analysis|||||||0.103
71702052|NCT04950686|142921137|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
71702053|NCT04950686|142921137|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.054|TWO_SIDED||||||Mixed Models Analysis|||||||0.054
71702054|NCT04950686|142921138|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
71702055|NCT04950686|142921138|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
71702056|NCT04950686|142921139|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.819|TWO_SIDED||||||Mixed Models Analysis|||||||0.819
71702057|NCT04950686|142921139|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.775|TWO_SIDED||||||Mixed Models Analysis|||||||0.775
71702058|NCT04950686|142921140|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
71702059|NCT04950686|142921140|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.579|TWO_SIDED||||||Mixed Models Analysis|||||||0.579
71702060|NCT04950686|142921141|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.485|TWO_SIDED||||||Mixed Models Analysis|||||||0.485
71702061|NCT04950686|142921141|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
71702062|NCT04950686|142921142|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.583|TWO_SIDED||||||Mixed Models Analysis|||||||0.583
71702063|NCT04950686|142921142|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.971|TWO_SIDED||||||Mixed Models Analysis|||||||0.971
71702064|NCT04950686|142921143|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.602|TWO_SIDED||||||Mixed Models Analysis|||||||0.602
71761971|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Pharyngeal domain||||||0.007
71641756|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.33||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||2.33|1.29|<0.001
71641757|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|||<|0.001|TWO_SIDED|95.0|1.92|3.03||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.03|1.92|<0.001
71641758|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41|||<|0.001|TWO_SIDED|95.0|1.87|2.96||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.96|1.87|<0.001
71641759|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71|||<|0.001|TWO_SIDED|95.0|1.16|2.25||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||2.25|1.16|<0.001
71641760|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.83|1.69|<0.001
71641761|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001|TWO_SIDED|95.0|1.8|2.93||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.93|1.80|<0.001
71641762|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|||<|0.001|TWO_SIDED|95.0|1.11|2.23||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||2.23|1.11|<0.001
71641763|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.66|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.79|1.66|<0.001
71641764|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.74|2.85||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.85|1.74|<0.001
71702065|NCT04950686|142921143|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.04||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
71761972|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Saliva domain||||||0.036
71641765|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.57|||<|0.001|TWO_SIDED|95.0|1.02|2.13||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||2.13|1.02|<0.001
71641766|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.78||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.78|1.59|<0.001
71641767|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.53|2.7||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.70|1.53|<0.001
71641768|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|1.04|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||2.21|1.04|<0.001
71641769|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|||<|0.001|TWO_SIDED|95.0|1.3|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.52|1.30|<0.001
71641770|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.12|||<|0.001|TWO_SIDED|95.0|1.52|2.72||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.72|1.52|<0.001
71641771|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||2.11|0.91|<0.001
71641772|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|||<|0.001|TWO_SIDED|95.0|1.34|2.55||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.55|1.34|<0.001
71641773|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.59|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.79|1.59|<0.001
71641774|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||<|0.001|TWO_SIDED|95.0|0.97|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||2.16|0.97|<0.001
71641775|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.28|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.52|1.28|<0.001
71641776|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.75||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.75|1.52|<0.001
71641777|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||<|0.001|TWO_SIDED|95.0|0.98|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||2.20|0.98|<0.001
71641778|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.26|2.54||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.54|1.26|<0.001
71641779|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.39|2.66||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.66|1.39|<0.001
71641780|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.001|TWO_SIDED|95.0|0.81|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||2.07|0.81|<0.001
71641781|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83|||<|0.001|TWO_SIDED|95.0|1.17|2.49||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.49|1.17|<0.001
71641782|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|||<|0.001|TWO_SIDED|95.0|1.13|2.43||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.43|1.13|<0.001
71641783|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.78|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||2.07|0.78|<0.001
71641784|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||<|0.001|TWO_SIDED|95.0|0.95|2.32||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.32|0.95|<0.001
71641785|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|||<|0.001|TWO_SIDED|95.0|0.94|2.29||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.29|0.94|<0.001
71761973|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Fear domain||||||0.004
71641786|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||<|0.001|TWO_SIDED|95.0|0.71|2.06||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||2.06|0.71|<0.001
71641787|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|||<|0.001|TWO_SIDED|95.0|0.88|2.27||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.27|0.88|<0.001
71641788|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42|||<|0.001|TWO_SIDED|95.0|0.73|2.1||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.10|0.73|<0.001
71641789|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001|TWO_SIDED|95.0|0.72|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||2.08|0.72|<0.001
71641790|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|95.0|0.53|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.96|0.53|<0.001
71641791|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.003|TWO_SIDED|95.0|0.38|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||1.79|0.38|0.003
71641792|NCT00913627|142802233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||2.02|0.61|<0.001
71641793|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.011|TWO_SIDED|95.0|0.12|0.91||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.91|0.12|0.011
71641794|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.028|TWO_SIDED|95.0|0.05|0.83||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.83|0.05|0.028
71641795|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.048|TWO_SIDED|95.0|0.0|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes||0.78|0.00|0.048
71641796|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||<|0.001|TWO_SIDED|95.0|0.69|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.96|0.69|<0.001
71641797|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.45|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.71|0.45|<0.001
71702066|NCT04950686|142921144|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.763|TWO_SIDED||||||Mixed Models Analysis|||||||0.763
71641798|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.002|TWO_SIDED|95.0|0.38|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes||1.63|0.38|0.002
71641799|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.46|3.06||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||3.06|1.46|<0.001
71641800|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|||<|0.001|TWO_SIDED|95.0|1.24|2.82||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.82|1.24|<0.001
71641801|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.74|2.31||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes||2.31|0.74|<0.001
71641802|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.78|3.5||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.50|1.78|<0.001
71641803|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||<|0.001|TWO_SIDED|95.0|1.81|3.51||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.51|1.81|<0.001
71641804|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16|||<|0.001|TWO_SIDED|95.0|1.32|3.0||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes||3.00|1.32|<0.001
71641805|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001|TWO_SIDED|95.0|2.39|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.12|2.39|<0.001
71641806|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||<|0.001|TWO_SIDED|95.0|2.57|4.28||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||4.28|2.57|<0.001
71641807|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.77|||<|0.001|TWO_SIDED|95.0|1.92|3.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes||3.63|1.92|<0.001
71641808|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.7|4.44||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.44|2.70|<0.001
71641809|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||4.53|2.82|<0.001
71641810|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001|TWO_SIDED|95.0|1.87|3.57||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours||3.57|1.87|<0.001
71641811|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|||<|0.001|TWO_SIDED|95.0|3.27|4.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.99|3.27|<0.001
71641812|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001|TWO_SIDED|95.0|3.24|4.95||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||4.95|3.24|<0.001
71641813|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001|TWO_SIDED|95.0|2.24|3.93||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours||3.93|2.24|<0.001
71641814|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||<|0.001|TWO_SIDED|95.0|3.36|5.13||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||5.13|3.36|<0.001
71641815|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.04|||<|0.001|TWO_SIDED|95.0|3.17|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||4.92|3.17|<0.001
71641816|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|||<|0.001|TWO_SIDED|95.0|2.11|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours||3.85|2.11|<0.001
71641817|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||<|0.001|TWO_SIDED|95.0|3.14|5.01||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||5.01|3.14|<0.001
71641818|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.001|TWO_SIDED|95.0|3.07|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||4.92|3.07|<0.001
71641819|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.83|||<|0.001|TWO_SIDED|95.0|1.91|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours||3.75|1.91|<0.001
71641820|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|||<|0.001|TWO_SIDED|95.0|2.78|4.71||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.71|2.78|<0.001
71641821|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|||<|0.001|TWO_SIDED|95.0|2.98|4.89||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||4.89|2.98|<0.001
71641822|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.001|TWO_SIDED|95.0|1.85|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours||3.75|1.85|<0.001
71641823|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61|||<|0.001|TWO_SIDED|95.0|2.65|4.56||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.56|2.65|<0.001
71641824|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|2.89|4.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||4.79|2.89|<0.001
71641825|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|||<|0.001|TWO_SIDED|95.0|1.65|3.54||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours||3.54|1.65|<0.001
71641826|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|||<|0.001|TWO_SIDED|95.0|2.54|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.53|2.54|<0.001
71641827|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.52|4.49||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||4.49|2.52|<0.001
71641828|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.69|3.65||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours||3.65|1.69|<0.001
71702067|NCT04950686|142921144|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.578|TWO_SIDED||||||Mixed Models Analysis|||||||0.578
71702068|NCT04950686|142921145|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
71761974|NCT00856518|143025871|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score||||||0.016
71641829|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.001|TWO_SIDED|95.0|2.19|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.21|2.19|<0.001
71641830|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|||<|0.001|TWO_SIDED|95.0|2.51|4.51||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||4.51|2.51|<0.001
71641831|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.49|3.48||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours||3.48|1.49|<0.001
71641832|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|2.17|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.21|2.17|<0.001
71641833|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|2.64|4.66||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||4.66|2.64|<0.001
71641834|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||<|0.001|TWO_SIDED|95.0|1.58|3.6||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours||3.60|1.58|<0.001
71641835|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|||<|0.001|TWO_SIDED|95.0|2.06|4.15||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.15|2.06|<0.001
71641836|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.53|4.61||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||4.61|2.53|<0.001
71641837|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.61|3.67||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours||3.67|1.61|<0.001
71641838|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|||<|0.001|TWO_SIDED|95.0|2.09|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.21|2.09|<0.001
71641839|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.001|TWO_SIDED|95.0|2.36|4.46||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||4.46|2.36|<0.001
71641840|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.36|3.44||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours||3.44|1.36|<0.001
71641841|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.03|||<|0.001|TWO_SIDED|95.0|1.94|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.12|1.94|<0.001
71641842|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|||<|0.001|TWO_SIDED|95.0|1.91|4.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||4.07|1.91|<0.001
71641843|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.28|3.42||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours||3.42|1.28|<0.001
71641844|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.57|3.83||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.83|1.57|<0.001
71641845|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|||<|0.001|TWO_SIDED|95.0|1.62|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.85|1.62|<0.001
71641846|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|||<|0.001|TWO_SIDED|95.0|1.14|3.37||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours||3.37|1.14|<0.001
71641847|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.64|||<|0.001|TWO_SIDED|95.0|1.51|3.76||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.76|1.51|<0.001
71641848|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45|||<|0.001|TWO_SIDED|95.0|1.33|3.56||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.56|1.33|<0.001
71641849|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.36|||<|0.001|TWO_SIDED|95.0|1.25|3.47||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours||3.47|1.25|<0.001
71641850|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||<|0.001|TWO_SIDED|95.0|0.86|3.19||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.19|0.86|<0.001
71641851|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.001|TWO_SIDED|95.0|0.75|3.05||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.05|0.75|0.001
71641852|NCT00913627|142802234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.001|TWO_SIDED|95.0|1.05|3.34||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours||3.34|1.05|<0.001
71641853|NCT00913627|142802235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42|||<|0.001|TWO_SIDED|95.0|1.94|2.89||p-value adjusted for baseline PSR and gender|ANOVA|||||2.89|1.94|<0.001
71641854|NCT00913627|142802235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.001|TWO_SIDED|95.0|1.92|2.86||p-value adjusted for baseline PSR and gender|ANOVA|||||2.86|1.92|<0.001
71641855|NCT00913627|142802235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||<|0.001|TWO_SIDED|95.0|1.58|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||||2.52|1.58|<0.001
71641856|NCT01110005|142802236|SUPERIORITY||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.7|2.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||2.3|0.7|0.34
71641857|NCT01110005|142802237|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4|TWO_SIDED|95.0|0.9|1.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR|||1.3|0.9|0.40
71641858|NCT01110005|142802238|SUPERIORITY|||||||0.69|||||||Cochran-Mantel-Haenszel|This method was used to control for site of recruitment||||||0.69
71641859|NCT03290781|142802279|SUPERIORITY||Difference in Proportion|0.451|||<|0.001|TWO_SIDED|95.0|0.296|0.572||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.572|0.296|<0.001
71641860|NCT03290781|142802279|SUPERIORITY||Difference in Proportion|0.278|||<|0.001|TWO_SIDED|95.0|0.142|0.401||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.401|0.142|<0.001
71641861|NCT03290781|142802280|SUPERIORITY||Difference in Proportion|0.463|||<|0.001|TWO_SIDED|95.0|0.31|0.585||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.585|0.310|<0.001
71641862|NCT03290781|142802280|SUPERIORITY||Difference in Proportion|0.339|||<|0.001|TWO_SIDED|95.0|0.197|0.463||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.463|0.197|<0.001
71641863|NCT03290781|142802281|SUPERIORITY||Difference in Proportion|0.497|||<|0.001|TWO_SIDED|95.0|0.337|0.62||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.620|0.337|<0.001
71641864|NCT03290781|142802281|SUPERIORITY||Difference in Proportion|0.294|||<|0.001|TWO_SIDED|95.0|0.148|0.425||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.425|0.148|<0.001
71641865|NCT03290781|142802282|SUPERIORITY||Difference in Proportion|0.277|||<|0.001|TWO_SIDED|95.0|0.129|0.398||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.398|0.129|<0.001
71641866|NCT03290781|142802282|SUPERIORITY||Difference in Proportion|0.191|||<|0.001|TWO_SIDED|95.0|0.067|0.305||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.305|0.067|<0.001
71641867|NCT03290781|142802283|SUPERIORITY||Difference in Proportion|0.488|||<|0.001|TWO_SIDED|95.0|0.329|0.613||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.613|0.329|<0.001
71641868|NCT03290781|142802283|SUPERIORITY||Difference in Proportion|0.343|||<|0.001|TWO_SIDED|95.0|0.194|0.471||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.471|0.194|<0.001
71702069|NCT04950686|142921145|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.538|TWO_SIDED||||||Mixed Models Analysis|||||||0.538
71886153|NCT00662792|143292979|SUPERIORITY||Differences of adjusted means|0.051|STANDARD_ERROR_OF_MEAN|0.03||0.0898|TWO_SIDED|95.0|-0.008|0.109|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.109|-0.008|0.0898
71702070|NCT04950686|142921146|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.41||0.662|TWO_SIDED||||||Mixed Models Analysis|||||||0.662
71702071|NCT04950686|142921146|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|1.81||0.406|TWO_SIDED||||||Mixed Models Analysis|||||||0.406
71702072|NCT04950686|142921147|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|1.64||0.105|TWO_SIDED||||||Mixed Models Analysis|||||||0.105
71702073|NCT04950686|142921147|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|1.91||0.487|TWO_SIDED||||||Mixed Models Analysis|||||||0.487
71702074|NCT04950686|142921148|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.68||0.171|TWO_SIDED||||||Mixed Models Analysis|||||||0.171
71702075|NCT04950686|142921148|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.06|STANDARD_ERROR_OF_MEAN|1.9||0.278|TWO_SIDED||||||Mixed Models Analysis|||||||0.278
71702076|NCT04950686|142921149|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.283|TWO_SIDED||||||Mixed Models Analysis|||||||0.283
71702077|NCT04950686|142921149|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
71702078|NCT04950686|142921150|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.965|TWO_SIDED||||||Mixed Models Analysis|||||||0.965
71702079|NCT04950686|142921150|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
71702080|NCT04950686|142921151|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.074
71702081|NCT04950686|142921151|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.828|TWO_SIDED||||||Mixed Models Analysis|||||||0.828
71702082|NCT04950686|142921152|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25||0.336|TWO_SIDED||||||Mixed Models Analysis|||||||0.336
71702083|NCT04950686|142921152|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.902|TWO_SIDED||||||Mixed Models Analysis|||||||0.902
71702084|NCT04950686|142921153|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.629|TWO_SIDED||||||Mixed Models Analysis|||||||0.629
71702085|NCT04950686|142921153|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.29||0.318|TWO_SIDED||||||Mixed Models Analysis|||||||0.318
71702086|NCT04950686|142921154|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.863|TWO_SIDED||||||Mixed Models Analysis|||||||0.863
71641869|NCT03290781|142802284|SUPERIORITY||Difference in Proportion|0.431|||<|0.001|TWO_SIDED|95.0|0.28|0.554||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.554|0.280|<0.001
71641870|NCT03290781|142802284|SUPERIORITY||Difference in Proportion|0.227|||<|0.001|TWO_SIDED|95.0|0.094|0.349||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.349|0.094|<0.001
71641871|NCT03290781|142802285|SUPERIORITY||Difference in Proportion|0.176|||<|0.001|TWO_SIDED|95.0|0.049|0.287||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.287|0.049|<0.001
71641872|NCT03290781|142802285|SUPERIORITY||Difference in Proportion|0.111|||<|0.005|TWO_SIDED|95.0|0.006|0.208||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||0.208|0.006|<0.005
71641873|NCT03290781|142802286|SUPERIORITY||||||<|0.001||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647-303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||<0.001
71641874|NCT03290781|142802286|SUPERIORITY||||||=|0.005||||||P-value was based on CMH chi-square test stratified by status of glucocorticoid use at SHP647- 303 baseline, prior anti-TNF treatment, and the degree of clinical response in the induction studies (whether remission is achieved or not).|Cochran-Mantel-Haenszel|||||||=0.005
71641875|NCT00834795|142802323|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|95.16||||||90.0|85.69|105.67|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.67|85.69|
71641876|NCT00834795|142802324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.27||||||90.0|90.34|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.59|90.34|
71641877|NCT00834795|142802325|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.36||||||90.0|90.2|102.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.93|90.20|
71641878|NCT00579345|142802331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.66|||||TWO_SIDED|95.0|0.45|0.98|||||A/H1N1(Day22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||0.98|0.45|
71641879|NCT00579345|142802331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||A/H3N2 (Day 22)-criterion was met|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.19|0.55|
71641880|NCT00579345|142802331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.69|||||TWO_SIDED|95.0|0.46|1.02|||||B (Day 22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.||1.02|0.46|
71641881|NCT00795821|142802341|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71641882|NCT00795821|142802343|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71641883|NCT00795821|142802345|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71641884|NCT00795821|142802347|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
71641885|NCT00795821|142802349|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.007
71641886|NCT00795821|142802351|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.056
71641887|NCT00795821|142802353|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
71702087|NCT04950686|142921154|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.299|TWO_SIDED||||||Mixed Models Analysis|||||||0.299
71641888|NCT00795821|142802355|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71641889|NCT00795821|142802357|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.003
71641890|NCT00795821|142802359|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model terms included treatment, investigator, and baseline score.||||||0.009
71641891|NCT00795821|142802361|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Severity of Overall Fatigue|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.008
71641892|NCT00795821|142802361|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Fatigue Interference with Daily Activities|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.024
71641893|NCT00795821|142802363|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for participants reporting use of primary doctor|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.261
71641894|NCT00795821|142802363|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||P-value for participants reporting use of specialist|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.868
71641895|NCT00795821|142802363|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||P-value for participants reporting other diagnostic tests|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.495
71641896|NCT00795821|142802363|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value for participants reporting prescribed medication|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.||||||0.189
71641897|NCT00795821|142802365|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for suicidal ideation|Fisher Exact|||||||0.737
71641898|NCT00795821|142802367|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for change in supine systolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||0.002
71641899|NCT00795821|142802367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in supine diastolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71641900|NCT00795821|142802369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.||||||<0.001
71641901|NCT01285713|142802372|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|95.0|||||Paired t-test|||||||0.0003
71641902|NCT00583453|142802394|SUPERIORITY_OR_OTHER|||||||0.674||||||Treatment x day interaction|Wilcoxon (Mann-Whitney)|||||||.674
71641903|NCT00583453|142802395|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment x day interaction reported as 0.018.|Wilcoxon (Mann-Whitney)|||||||0.018
71641904|NCT00583453|142802396|SUPERIORITY_OR_OTHER|||||||0.214||||||Treatment x day interaction = 0.214|Wilcoxon (Mann-Whitney)|||||||.214
71641905|NCT00583453|142802398|SUPERIORITY_OR_OTHER|||||||0.036||||||treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003|Wilcoxon (Mann-Whitney)|||||||0.036
71641906|NCT04523168|142802399|SUPERIORITY|||||||0.0137|||||||Wilcoxon (Mann-Whitney)|||Baseline, 120 days||||0.0137
71641907|NCT04523168|142802401|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71641908|NCT03868891|142802423|OTHER|||||||1|||||||Wilcoxon signed-rank|||inflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||1.00
71641909|NCT03868891|142802423|OTHER|||||||0.734|||||||Wilcoxon signed-rank|||deflation test at 2 months compared with baseline; EMST150 + Eustachi not included because visit 2 measurements only available for 1 participant (2 ears)||||0.734
71641910|NCT03868891|142802424|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with baseline||||0.25
71641911|NCT03868891|142802424|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with baseline||||0.75
71641912|NCT03868891|142802425|OTHER|||||||0.25|||||||Wilcoxon signed-rank|||inflation test at 4 months compared with 2 months||||0.25
71641913|NCT03868891|142802425|OTHER|||||||0.75|||||||Wilcoxon signed-rank|||deflation test at 4 months compared with 2 months||||0.75
71641914|NCT03123094|142802445|OTHER||Slope|0.9533|STANDARD_ERROR_OF_MEAN|0.0803|||TWO_SIDED|95.0|0.781|1.1256|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter AUC0-∞, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1256|0.7810|
71641915|NCT03123094|142802446|OTHER||Slope|1.0014|STANDARD_ERROR_OF_MEAN|0.0568|||TWO_SIDED|95.0|0.8809|1.1219|||||Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of spesolimab was to be assessed based on the exposure parameter Cmax, determined for the 3 intravenous dose levels (perfect dose proportionality would correspond to a slope of 1).||1.1219|0.8809|
71641916|NCT03181594|142802505|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.||||<0.001
71641917|NCT03181594|142802507|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71641918|NCT03181594|142802508|SUPERIORITY||||||<|0.001||||||p\<0.001 at all time periods. p\<0.05 was considered statistically significant.|Wilcoxon signed rank|||||||<0.001
71641919|NCT00567320|142802509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|TWO_SIDED|95.0|||||Mixed Models Analysis|||HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.||||0.84
71641920|NCT00834340|142802547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|92.2|
71641921|NCT00834340|142802548|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|94.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.0|
71641922|NCT00834340|142802549|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|98.7|
71641923|NCT01175018|142802552|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71641924|NCT01175018|142802553|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71641925|NCT01175018|142802554|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641926|NCT01175018|142802555|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71641927|NCT01175018|142802556|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
71641928|NCT01175018|142802557|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641929|NCT01175018|142802558|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71641930|NCT01175018|142802559|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71641931|NCT01175018|142802560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>0.05
71641932|NCT01175018|142802561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641933|NCT01175018|142802562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641934|NCT01175018|142802563|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641935|NCT01175018|142802564|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641936|NCT01175018|142802565|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641937|NCT01175018|142802566|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641938|NCT01175018|142802567|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71641939|NCT00840073|142802573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.0||||||90.0|85.13|108.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.27|85.13|
71702088|NCT04950686|142921155|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.010
71641940|NCT00840073|142802574|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.81||||||90.0|96.72|111.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.41|96.72|
71641941|NCT00840073|142802575|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|102.37||||||90.0|97.34|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.65|97.34|
71641942|NCT00840073|142802576|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.76||||||90.0|100.08|107.57|||||Informational Purposes Only|||107.57|100.08|
71641943|NCT00840073|142802577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|103.34||||||90.0|100.84|105.92|||||Informational Purposes Only|||105.92|100.84|
71641944|NCT01940341|142802580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 130 and 260 participants in the TDF group and TAF groups, respectively were planned to give 90% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size was based on the assumption that the expected difference (TAF-TDF) in proportion of participants with HBV DNA\<29 IU/mL was 0 and the proportion of participants with HBV DNA\<29 IU/mL in the TDF group was 91%. All missing data were treated as not achieving the primary endpoint.|Difference in proportions|1.8|||||TWO_SIDED|95.0|-3.6|7.2|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||7.2|-3.6|
71641945|NCT00841698|142802596|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|97.34||||||90.0|91.67|103.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.35|91.67|
71641946|NCT00841698|142802597|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.46||||||90.0|90.22|98.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.89|90.22|
71641947|NCT00841698|142802598|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.83||||||90.0|89.96|99.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.96|89.96|
71641948|NCT00185458|142802599|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.128
71641949|NCT00185458|142802600|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.||||0.296
71641950|NCT00185458|142802602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71823362|NCT00924560|143149820|NON_INFERIORITY_OR_EQUIVALENCE|28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.49|-0.61|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.61|-1.49|
71823363|NCT00924560|143149821|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|-0.00|
71641951|NCT00185458|142802604|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.027
71641952|NCT00185458|142802605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641953|NCT00185458|142802606|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641954|NCT00185458|142802607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641955|NCT00185458|142802608|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.054
71641956|NCT00185458|142802609|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641957|NCT00185458|142802610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641958|NCT00185458|142802611|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71702089|NCT04950686|142921155|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.119|TWO_SIDED||||||Mixed Models Analysis|||||||0.119
71702090|NCT04950686|142921156|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.161|TWO_SIDED||||||Mixed Models Analysis|||||||0.161
71702091|NCT04950686|142921156|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
71702092|NCT04950686|142921157|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.810
71702093|NCT04950686|142921157|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.901|TWO_SIDED||||||Mixed Models Analysis|||||||0.901
71702094|NCT04950686|142921158|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.145|TWO_SIDED||||||Mixed Models Analysis|||||||0.145
71702095|NCT04950686|142921158|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
71702096|NCT04950686|142921159|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.272|TWO_SIDED||||||Mixed Models Analysis|||||||0.272
71702097|NCT04950686|142921159|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.689|TWO_SIDED||||||Mixed Models Analysis|||||||0.689
71702098|NCT04950686|142921160|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.824|TWO_SIDED||||||Mixed Models Analysis|||||||0.824
71641959|NCT00185458|142802612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641960|NCT00185458|142802613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641961|NCT00185458|142802614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641962|NCT00185458|142802615|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.175
71641963|NCT00185458|142802616|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||0.062
71641964|NCT00185458|142802617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.||||<0.001
71641965|NCT00835536|142802650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|93.1|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108|93.1|
71641966|NCT00835536|142802651|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.5||||||90.0|92.1|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|92.1|
71641967|NCT03769025|142802670|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||.1
71641968|NCT03769025|142802671|SUPERIORITY|||||||0.959|||||||t-test, 2 sided|||||||.959
71641969|NCT03123471|142802706|SUPERIORITY||Difference in Response|29.6|||<|0.0001|TWO_SIDED|95.0|19.5|39.7|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||39.7|19.5|< 0.0001
71641970|NCT03123471|142802707|SUPERIORITY||Difference in Response|23.0|||<|0.0001|TWO_SIDED|95.0|11.5|34.6|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||34.6|11.5|< 0.0001
71641971|NCT03123471|142802708|SUPERIORITY||Difference in Response|26.2|||<|0.0001|TWO_SIDED|95.0|13.9|38.5|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||38.5|13.9|< 0.0001
71641972|NCT03123471|142802709|SUPERIORITY||Difference in Response|17.0|||<|0.0001|TWO_SIDED|95.0|9.8|24.2|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.2|9.8|<0.0001
71641973|NCT03123471|142802709|SUPERIORITY||Difference in Response|22.1|||<|0.0001|TWO_SIDED|95.0|12.9|31.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4. The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.4|12.9|<0.0001
71641974|NCT03123471|142802709|SUPERIORITY||Difference in Response|20.1||||0.0003|TWO_SIDED|95.0|9.1|31.0|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.0|9.1|0.0003
71641975|NCT03123471|142802709|SUPERIORITY||Difference in Response|20.6||||0.0007|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||32.4|8.7|0.0007
71641976|NCT03123471|142802710|SUPERIORITY||Difference in Response|14.6||||0.0025|TWO_SIDED|95.0|5.1|24.1|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||24.1|5.1|0.0025
71641977|NCT03123471|142802710|SUPERIORITY||Difference in Response|21.3|||<|0.0001|TWO_SIDED|95.0|10.6|31.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||31.9|10.6|<0.0001
71641978|NCT03123471|142802710|SUPERIORITY||Difference in Response|22.0||||0.0003|TWO_SIDED|95.0|10.2|33.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.||33.9|10.2|0.0003
71641979|NCT03123471|142802710|SUPERIORITY||Difference in Response|27.0|||<|0.0001|TWO_SIDED|95.0|15.1|38.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.||38.9|15.1|<0.0001
71641980|NCT03123471|142802711|SUPERIORITY||Difference in LS Mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.17|-1.73|||ANCOVA|Treatment and stratification factor (Baseline ScPGA moderate or severe) as independent variables and baseline value as a covariate variable.||||-1.73|-4.17|<0.0001
71641981|NCT01641380|142802715|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|||<|0.05|TWO_SIDED|95.0|-1.4|0.06|||Regression, Linear|||We also evaluated the difference between the number of days after the scheduled appointment patients returned.||.06|-1.4|<.05
71641982|NCT01641380|142802715|SUPERIORITY_OR_OTHER_LEGACY||Difference of proportions|0.417||||0.5187|TWO_SIDED|95.0|-13.3307|24.8818|||Chi-squared||Intervention 34/50; Control : 28/50|On time for 1st follow-up visit||24.8818|-13.3307|0.5187
71641983|NCT01641380|142802718|SUPERIORITY_OR_OTHER_LEGACY||[Proportion of Eligible Patients Enrolle|0.948|||||TWO_SIDED|||||||||||||
71641984|NCT03238781|142802724|SUPERIORITY||difference in least square mean|0.26||||0.66|TWO_SIDED|95.0|-0.88|1.4||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.40|-0.88|0.66
71641985|NCT03238781|142802724|SUPERIORITY||difference in least square mean|0.27||||0.65|TWO_SIDED|95.0|-0.89|1.43||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.43|-0.89|0.65
71641986|NCT03238781|142802725|SUPERIORITY||Odds Ratio (OR)|0.82||||0.57|TWO_SIDED|95.0|0.41|1.62||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.62|0.41|0.57
71641987|NCT03238781|142802725|SUPERIORITY||Odds Ratio (OR)|0.76||||0.45|TWO_SIDED|95.0|0.37|1.54||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).||1.54|0.37|0.45
71641988|NCT03238781|142802726|SUPERIORITY||difference in least square mean|-0.03||||0.94|TWO_SIDED|95.0|-0.87|0.81||2-sided significance level of 0.05|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||0.81|-0.87|0.94
71641989|NCT03238781|142802726|SUPERIORITY||difference in least square mean|-0.09||||0.84|TWO_SIDED|95.0|-0.94|0.77||2-sided significance level of 0.05|Mixed Models Analysis|||||0.77|-0.94|0.84
71641990|NCT03238781|142802727|SUPERIORITY||difference in least square mean|-0.28||||0.81|TWO_SIDED|95.0|-2.56|2.01||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.01|-2.56|0.81
71641991|NCT03238781|142802727|SUPERIORITY||difference in least square mean|0.31||||0.79|TWO_SIDED|95.0|-2.01|2.63||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.63|-2.01|0.79
71641992|NCT03238781|142802728|SUPERIORITY||difference in least square mean|-0.86||||0.46|TWO_SIDED|95.0|-3.15|1.44||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||1.44|-3.15|0.46
71641993|NCT03238781|142802728|SUPERIORITY||difference in least square mean|0.56||||0.64|TWO_SIDED|95.0|-1.77|2.89||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.||2.89|-1.77|0.64
71823364|NCT00924560|143149821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
71641994|NCT01249651|142802744|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
71641995|NCT01581658|142802749|SUPERIORITY_OR_OTHER||Geometric mean ratio|128.82|||||TWO_SIDED|90.0|105.962|156.604|||ANOVA|The model includes fixed effect for the renal function group||||156.604|105.962|
71641996|NCT01581658|142802749|SUPERIORITY_OR_OTHER||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|118.306|174.848|||ANOVA|The model includes fixed effect for the renal function group||||174.848|118.306|
71641997|NCT01581658|142802749|SUPERIORITY_OR_OTHER||Geometric mean ratio|152.31|||||TWO_SIDED|90.0|125.287|185.166|||ANOVA|The model includes fixed effect for the renal function group||||185.166|125.287|
71641998|NCT01581658|142802750|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.5|||||TWO_SIDED|90.0|72.236|121.015|||ANOVA|The model includes fixed effect for the renal function group||||121.015|72.236|
71641999|NCT01581658|142802750|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.18|||||TWO_SIDED|90.0|71.216|119.305|||ANOVA|The model includes fixed effect for the renal function group||||119.305|71.216|
71642000|NCT01581658|142802750|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.01|||||TWO_SIDED|90.0|72.63|121.674|||ANOVA|The model includes fixed effect for the renal function group||||121.674|72.630|
71642001|NCT02538523|142802751|SUPERIORITY||||||<|0.005|||||||Fisher Exact|||A Fischer's Exact Test for two independent proportions was conducted to compare the statistical significance of the 44.8% difference in proportion of successes between procedure groups at two-months post-procedure (study endpoint) relative to baseline evaluation.||||<0.005
71642002|NCT02538523|142802752|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Differences is the statistical significance of change scores in ODI total score from study baseline to endpoint (two-months post-procedure) were evaluated by Analysis of Covariance (ANCOVA), with change from baseline to endpoint in ODI total score as the dependent variable, baseline ODI total score as the covariate and procedure group (Erchonia FX-635 or placebo laser) as a main effect.||||<0.05
71642003|NCT00787254|142802757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.14|0.4499|||Log Rank|||||0.4499|0.1400|<0.0001
71642004|NCT00787254|142802758|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
71642005|NCT00787254|142802759|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0041
71642006|NCT00787254|142802760|SUPERIORITY_OR_OTHER|||||||0.0652||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0652
71642007|NCT00787254|142802761|SUPERIORITY_OR_OTHER|||||||0.9836||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9836
71642008|NCT00787254|142802763|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
71642009|NCT00787254|142802764|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0161
71642010|NCT00787254|142802765|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0068
71642011|NCT00787254|142802766|SUPERIORITY_OR_OTHER|||||||0.2363||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2363
71642012|NCT00787254|142802768|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71642013|NCT00787254|142802769|SUPERIORITY_OR_OTHER|||||||0.4788||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4788
71642014|NCT00787254|142802770|SUPERIORITY_OR_OTHER|||||||0.6607||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6607
71642015|NCT00787254|142802771|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8811
71642016|NCT00787254|142802772|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71642017|NCT00787254|142802774|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2060
71642018|NCT00787254|142802775|SUPERIORITY_OR_OTHER|||||||0.5099||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5099
71642019|NCT00787254|142802776|SUPERIORITY_OR_OTHER|||||||0.7794||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7794
71642020|NCT00787254|142802777|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71642021|NCT00787254|142802779|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6980
71642022|NCT00787254|142802780|SUPERIORITY_OR_OTHER|||||||0.4599||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4599
71642023|NCT00787254|142802781|SUPERIORITY_OR_OTHER|||||||0.0355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0355
71642024|NCT00787254|142802782|SUPERIORITY_OR_OTHER|||||||0.7325||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7325
71642025|NCT00787254|142802784|SUPERIORITY_OR_OTHER|||||||0.8262||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8262
71642026|NCT00787254|142802785|SUPERIORITY_OR_OTHER|||||||0.7244||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7244
71642027|NCT00787254|142802786|SUPERIORITY_OR_OTHER|||||||0.9566||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9566
71642028|NCT00787254|142802787|SUPERIORITY_OR_OTHER|||||||0.2008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2008
71642029|NCT00787254|142802789|SUPERIORITY_OR_OTHER|||||||0.0703||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0703
71642030|NCT00787254|142802790|SUPERIORITY_OR_OTHER|||||||0.3046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3046
71642031|NCT00787254|142802791|SUPERIORITY_OR_OTHER|||||||0.7121||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7121
71642032|NCT00787254|142802792|SUPERIORITY_OR_OTHER|||||||0.1522||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1522
71642033|NCT00787254|142802794|SUPERIORITY_OR_OTHER|||||||0.5328||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5328
71642034|NCT00787254|142802795|SUPERIORITY_OR_OTHER|||||||0.7223||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7223
71642035|NCT00787254|142802796|SUPERIORITY_OR_OTHER|||||||0.3117||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3117
71642036|NCT00787254|142802797|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||t-test, 2 sided|||||||0.4344
71642037|NCT00787254|142802799|SUPERIORITY_OR_OTHER|||||||0.1571||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1571
71642038|NCT00787254|142802800|SUPERIORITY_OR_OTHER|||||||0.2503||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2503
71642039|NCT00787254|142802801|SUPERIORITY_OR_OTHER|||||||0.4028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4028
71642040|NCT00787254|142802802|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71642041|NCT02925884|142802845|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Decreased Cognitive Functions.||||0.011
71642042|NCT02925884|142802845|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Eyestrain.||||<0.001
71702099|NCT04950686|142921160|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.271|TWO_SIDED||||||Mixed Models Analysis|||||||0.271
71702100|NCT04950686|142921161|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.391|TWO_SIDED||||||Mixed Models Analysis|||||||0.391
71702101|NCT04950686|142921161|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.04||0.952|TWO_SIDED||||||Mixed Models Analysis|||||||0.952
71702102|NCT04950686|142921162|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.925|TWO_SIDED||||||Mixed Models Analysis|||||||0.925
71702103|NCT04950686|142921162|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.05||0.153|TWO_SIDED||||||Mixed Models Analysis|||||||0.153
71702104|NCT04950686|142921163|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.495|TWO_SIDED||||||Mixed Models Analysis|||||||0.495
71702105|NCT04950686|142921163|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.229|TWO_SIDED||||||Mixed Models Analysis|||||||0.229
71702106|NCT04950686|142921164|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.753|TWO_SIDED||||||Mixed Models Analysis|||||||0.753
71702107|NCT04950686|142921164|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
71702108|NCT04950686|142921165|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.541|TWO_SIDED||||||Mixed Models Analysis|||||||0.541
71702109|NCT04950686|142921165|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
71702110|NCT04950686|142921166|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.375|TWO_SIDED||||||Mixed Models Analysis|||||||0.375
71702111|NCT04950686|142921166|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.293|TWO_SIDED||||||Mixed Models Analysis|||||||0.293
71702112|NCT04950686|142921167|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.97|STANDARD_ERROR_OF_MEAN|1.89||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
71702113|NCT04950686|142921167|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.21||0.163|TWO_SIDED||||||Mixed Models Analysis|||||||0.163
71642043|NCT02925884|142802845|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Physical Discomfort.||||0.009
71702114|NCT04950686|142921168|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.09|STANDARD_ERROR_OF_MEAN|1.99||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
71642044|NCT02925884|142802845|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Deceased Visual Function.||||<0.001
71642045|NCT02925884|142802845|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunnar OTC Condition and the Control Condition on the factor score of Poor Balance.||||0.28
71642046|NCT02925884|142802846|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
71702115|NCT04950686|142921168|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|2.27||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
71702116|NCT04950686|142921169|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.83|STANDARD_ERROR_OF_MEAN|2.06||0.064|TWO_SIDED||||||Mixed Models Analysis|||||||0.064
71702117|NCT04950686|142921169|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.37|STANDARD_ERROR_OF_MEAN|2.27||0.137|TWO_SIDED||||||Mixed Models Analysis|||||||0.137
71702118|NCT04950686|142921170|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-5.05|STANDARD_ERROR_OF_MEAN|1.52||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
71702119|NCT04950686|142921170|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.25|STANDARD_ERROR_OF_MEAN|1.76||0.065|TWO_SIDED||||||Mixed Models Analysis|||||||0.065
71702120|NCT04950686|142921171|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.67|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED||||||Mixed Models Analysis|||||||0.015
71702121|NCT04950686|142921171|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|1.78||0.152|TWO_SIDED||||||Mixed Models Analysis|||||||0.152
71702122|NCT04950686|142921172|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.78|STANDARD_ERROR_OF_MEAN|1.78||0.034|TWO_SIDED||||||Mixed Models Analysis|||||||0.034
71702123|NCT04950686|142921172|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-3.13|STANDARD_ERROR_OF_MEAN|1.84||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
71702124|NCT04950686|142921173|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
71702125|NCT04950686|142921173|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.532|TWO_SIDED||||||Mixed Models Analysis|||||||0.532
71702126|NCT04950686|142921174|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
71702127|NCT04950686|142921174|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.443|TWO_SIDED||||||Mixed Models Analysis|||||||0.443
71702128|NCT04950686|142921175|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
71823365|NCT00924560|143149821|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71642047|NCT02925884|142802847|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Red Color Perception.||||0.009
71642048|NCT02925884|142802847|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Green Color Perception.||||0.446
71642049|NCT02925884|142802847|SUPERIORITY|||||||0.953|||||||Mixed Models Analysis|||Null hypothesis: No difference between the Gunna OTC Glasses condition and the Control condition on Blue Color Perception.||||0.953
71642050|NCT02925884|142802848|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
71642051|NCT02925884|142802849|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
71642052|NCT02925884|142802850|SUPERIORITY|||||||0.343|||||||Mixed Models Analysis|||||||0.343
71642053|NCT02925884|142802851|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||||||0.489
71642054|NCT02925884|142802852|SUPERIORITY|||||||0.885|||||||Mixed Models Analysis|||||||0.885
71642055|NCT02925884|142802853|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71642056|NCT02925884|142802854|SUPERIORITY|||||||0.359|||||||Mixed Models Analysis|||||||0.359
71642057|NCT02301975|142802859|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit PM FEV1 for FF/VI and FP/S was more than -100 milliliter (mL)|Least square mean change difference|0.019|||||TWO_SIDED|95.0|-0.011|0.049||||||||0.049|-0.011|
71642058|NCT02301975|142802859|OTHER||Least square mean change difference|0.123|||<|0.001|TWO_SIDED|95.0|0.093|0.153|||Mixed Models Analysis|||||0.153|0.093|<0.001
71642059|NCT02301975|142802859|OTHER||Least square mean change difference|0.104|||<|0.001|TWO_SIDED|95.0|0.074|0.134|||Mixed Models Analysis|||||0.134|0.074|<0.001
71642060|NCT02301975|142802860|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit for FF/VI and FP/S was more than -100 mL|Least square mean change difference|0.006|||||TWO_SIDED|95.0|-0.027|0.04||||||||0.040|-0.027|
71642061|NCT02301975|142802860|OTHER||Least square mean change difference|0.12|||<|0.001|TWO_SIDED|95.0|0.086|0.153|||Mixed Models Analysis|||||0.153|0.086|<0.001
71642062|NCT02301975|142802860|OTHER||Least square mean change difference|0.113|||<|0.001|TWO_SIDED|95.0|0.08|0.147|||Mixed Models Analysis|||||0.147|0.080|<0.001
71642063|NCT02301975|142802861|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.5|3.0||||||||3.0|-0.5|
71642064|NCT02301975|142802861|OTHER||Least square mean change difference|2.7||||0.002|TWO_SIDED|95.0|0.9|4.4|||ANCOVA|||||4.4|0.9|0.002
71642065|NCT02301975|142802861|OTHER||Least square mean change difference|1.4||||0.106|TWO_SIDED|95.0|-0.3|3.2|||ANCOVA|||||3.2|-0.3|0.106
71642066|NCT02301975|142802862|OTHER||Least square mean change difference|1.2|||||TWO_SIDED|95.0|-0.7|3.1||||||||3.1|-0.7|
71642067|NCT02301975|142802862|OTHER||Least square mean change difference|2.7||||0.004|TWO_SIDED|95.0|0.8|4.5|||ANCOVA|||||4.5|0.8|0.004
71642068|NCT02301975|142802862|OTHER||Least square mean change difference|1.5||||0.115|TWO_SIDED|95.0|-0.4|3.3|||ANCOVA|||||3.3|-0.4|0.115
71642069|NCT02301975|142802863|OTHER||Least square mean change difference|5.2|||||TWO_SIDED|95.0|1.1|9.4||||||||9.4|1.1|
71642070|NCT02301975|142802863|OTHER||Least square mean change difference|21.5|||<|0.001|TWO_SIDED|95.0|17.4|25.6|||ANCOVA|||||25.6|17.4|<0.001
71642071|NCT02301975|142802863|OTHER||Least square mean change difference|16.3|||<|0.001|TWO_SIDED|95.0|12.2|20.4|||ANCOVA|||||20.4|12.2|<0.001
71642072|NCT02301975|142802864|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.53|1.54||||||||1.54|0.53|
71642073|NCT02301975|142802864|OTHER||Odds Ratio (OR)|1.15||||0.595|TWO_SIDED|95.0|0.69|1.9|||Regression, Logistic|||||1.90|0.69|0.595
71642074|NCT02301975|142802864|OTHER||Odds Ratio (OR)|1.27||||0.372|TWO_SIDED|95.0|0.75|2.12|||Regression, Logistic|||||2.12|0.75|0.372
71642075|NCT02301975|142802865|OTHER||Least square mean change difference|5.0|||||TWO_SIDED|95.0|0.7|9.3||||||||9.3|0.7|
71642076|NCT02301975|142802865|OTHER||Least square mean change difference|19.2|||<|0.001|TWO_SIDED|95.0|14.9|23.5|||ANCOVA|||||23.5|14.9|<0.001
71642077|NCT02301975|142802865|OTHER||Least square mean change difference|14.2|||<|0.001|TWO_SIDED|95.0|9.9|18.5|||ANCOVA|||||18.5|9.9|<0.001
71642078|NCT03635320|142802876|NON_INFERIORITY|non-inferiority margin of -10%|95%CI|0.0|||||TWO_SIDED|95.0|-4.53|4.42|||Newcombe-Wilson scoring method|Using the Newcombe-Wilson scoring method, the difference of fracture union rate between the TFNA group and the PFNA-II group was 0.|If the lower limit of 95% CI of the difference in the rates of the study group and the control group is greater than the non-inferiority margin of -10%, then the investigational product is considered non-inferior to the control product.|||4.42|-4.53|
71642079|NCT00835575|142802890|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.52||||||90.0|92.84|106.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.69|92.84|
71642080|NCT00835575|142802891|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.59||||||90.0|99.13|108.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.25|99.13|
71702129|NCT04950686|142921175|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.726|TWO_SIDED||||||Mixed Models Analysis|||||||0.726
71702130|NCT04950686|142921176|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.282|TWO_SIDED||||||Mixed Models Analysis|||||||0.282
71823366|NCT00924560|143149821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.02|-0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.01|-0.02|
71642081|NCT00835575|142802892|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.87||||||90.0|99.47|108.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.46|99.47|
71642082|NCT01609257|142802904|SUPERIORITY_OR_OTHER|||||||0.674||||||No multiplicity adjustment.|Fisher Exact|||||||0.674
71642083|NCT01609257|142802911|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||||||0.001
71702131|NCT04950686|142921176|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.591|TWO_SIDED||||||Mixed Models Analysis|||||||0.591
71702132|NCT04950686|142921177|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.675|TWO_SIDED||||||Mixed Models Analysis|||||||0.675
71702133|NCT04950686|142921177|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.359|TWO_SIDED||||||Mixed Models Analysis|||||||0.359
71702134|NCT04950686|142921178|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.rt-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.685|TWO_SIDED||||||Mixed Models Analysis|||||||0.685
71702135|NCT04950686|142921178|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.198|TWO_SIDED||||||Mixed Models Analysis|||||||0.198
71702136|NCT04950686|142921179|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.-type scale from 1 (strongly disagree) to 4 (strongly agree); higher scores indicate greater self-efficacy to use a dental dam; range = 1-4|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Mixed Models Analysis|||||||0.460
71702137|NCT04950686|142921179|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
71702138|NCT04950686|142921180|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
71702139|NCT04950686|142921180|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.939|TWO_SIDED||||||Mixed Models Analysis|||||||0.939
71702140|NCT04950686|142921181|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.655|TWO_SIDED||||||Mixed Models Analysis|||||||0.655
71702141|NCT04950686|142921181|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.315|TWO_SIDED||||||Mixed Models Analysis|||||||0.315
71702142|NCT04950686|142921182|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.04||0.966|TWO_SIDED||||||Mixed Models Analysis|||||||0.966
71702143|NCT04950686|142921182|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.708|TWO_SIDED||||||Mixed Models Analysis|||||||0.708
71702144|NCT04950686|142921183|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.04||0.887|TWO_SIDED||||||Mixed Models Analysis|||||||0.887
71823367|NCT00924560|143149822|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|||||TWO_SIDED|95.0|-0.08|0.42||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.42|-0.08|
71823368|NCT00924560|143149822|SUPERIORITY_OR_OTHER||LS mean Difference|-0.43|||||TWO_SIDED|95.0|-0.68|-0.18||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.18|-0.68|
71642084|NCT01609257|142802912|SUPERIORITY_OR_OTHER|||||||0.008||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 1||||0.008
71642085|NCT01609257|142802912|SUPERIORITY_OR_OTHER|||||||0.037||||||Statistically significant at p\<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 2||||0.037
71642086|NCT01609257|142802913|SUPERIORITY_OR_OTHER|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||||||0.199
71642087|NCT01609257|142802914|SUPERIORITY_OR_OTHER|||||||0.562||||||Comparison of % Positive|Fisher Exact|||Any Day 1 to 30||||0.562
71642088|NCT03049748|142802937|OTHER|This is a pilot randomized trial with a purpose of establishing preliminary efficacy data to inform future studies.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71642089|NCT03049748|142802938|OTHER|Same rationale as the primary outcome.|||||>|0.05||||||All p-values across time periods, between groups, were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
71642090|NCT03049748|142802939|OTHER||||||>|0.05||||||All p values between groups across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
71642091|NCT03049748|142802940|OTHER||||||>|0.05||||||All p-values between groups across time periods were \>.05|Wilcoxon (Mann-Whitney)|||||||>.05
71642092|NCT03049748|142802941|OTHER||||||>|0.05||||||All p-values between group differences across time periods were \> .05|Wilcoxon (Mann-Whitney)|||||||>.05
71642093|NCT03049748|142802942|OTHER|||||||0.05||||||Differences in group hospitalization rates p-values: T1 = .093; T2 = .008; T3 = .029|Wilcoxon (Mann-Whitney)|||||||0.05
71642094|NCT00835484|142802943|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.15||||||90.0|91.77|102.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.83|91.77|
71642095|NCT00835484|142802944|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.8||||||90.0|95.1|106.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.84|95.1|
71702145|NCT04950686|142921183|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
71702146|NCT04950686|142921184|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.217|TWO_SIDED||||||Mixed Models Analysis|||||||0.217
71642096|NCT00835484|142802945|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.39||||||90.0|95.89|107.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.2|95.89|
71642097|NCT04383587|142802946|SUPERIORITY||||||>|0.18|||||||Fisher Exact|||Participants were grouped by age (18-35 vs. 36-50 vs. 51-65 vs. \>65), Sex at birth (Female vs. Male). and Occupational Role (Technician vs Anesthesiologist vs Advanced Practice Provider vs. Attendant Aide vs. CRNA vs. OR nurse vs Perfusionist vs Surgeon).||||>0.18
71642098|NCT04994535|142802949|SUPERIORITY||Difference (%)|30.9|||<|0.0001|TWO_SIDED|95.0|24.5|37.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.4|24.5|<.0001
71642099|NCT04994535|142802950|SUPERIORITY||Difference (%)|38.9|||<|0.0001|TWO_SIDED|95.0|31.3|46.4||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||46.4|31.3|<0.0001
71642100|NCT04994535|142802951|SUPERIORITY||Difference (%)|36.9|||<|0.0001|TWO_SIDED|95.0|29.1|44.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.7|29.1|<0.0001
71642101|NCT04994535|142802954|SUPERIORITY||Difference (%)|50.2|||<|0.0001|TWO_SIDED|95.0|42.0|58.3||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.3|42.0|<.0001
71642102|NCT04994535|142802955|SUPERIORITY||Difference (%)|27.1|||<|0.0001|TWO_SIDED|95.0|18.1|36.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||36.1|18.1|<.0001
71642103|NCT04994535|142802956|SUPERIORITY||Difference (%)|35.8|||<|0.0001|TWO_SIDED|95.0|27.4|44.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.2|27.4|<.0001
71702147|NCT04950686|142921184|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.879|TWO_SIDED||||||Mixed Models Analysis|||||||0.879
71702148|NCT04950686|142921185|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.866|TWO_SIDED||||||Mixed Models Analysis|||||||0.866
71642104|NCT04994535|142802957|SUPERIORITY||Difference (SE)|-4.4|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-5.4|-3.4||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.4|-5.4|<.0001
71642105|NCT04994535|142802960|SUPERIORITY||Difference (%)|42.9|||<|0.0001|TWO_SIDED|95.0|34.8|51.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||51.0|34.8|<0.0001
71642106|NCT04994535|142802961|SUPERIORITY||Difference (%)|49.4|||<|0.0001|TWO_SIDED|95.0|40.8|58.1||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||58.1|40.8|<0.0001
71642107|NCT04994535|142802962|SUPERIORITY||Difference (%)|28.8|||<|0.0001|TWO_SIDED|95.0|19.4|38.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||38.2|19.4|<0.0001
71702149|NCT04950686|142921185|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.695|TWO_SIDED||||||Mixed Models Analysis|||||||0.695
71702150|NCT04950686|142921186|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.06||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
71702151|NCT04950686|142921186|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.451|TWO_SIDED||||||Mixed Models Analysis|||||||0.451
71702152|NCT04950686|142921187|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.442|TWO_SIDED||||||Mixed Models Analysis|||||||0.442
71702153|NCT04950686|142921187|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.082|TWO_SIDED||||||Mixed Models Analysis|||||||0.082
71702154|NCT04950686|142921188|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED||||||Mixed Models Analysis|||||||0.236
71702155|NCT04950686|142921188|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.674|TWO_SIDED||||||Mixed Models Analysis|||||||0.674
71702156|NCT04950686|142921189|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.135|TWO_SIDED||||||Mixed Models Analysis|||||||0.135
71702157|NCT04950686|142921189|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.500
71702158|NCT04950686|142921190|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.09||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
71702159|NCT04950686|142921190|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.214|TWO_SIDED||||||Mixed Models Analysis|||||||0.214
71702160|NCT04950686|142921191|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.337|TWO_SIDED||||||Mixed Models Analysis|||||||0.337
71702161|NCT04950686|142921191|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.07||0.957|TWO_SIDED||||||Mixed Models Analysis|||||||0.957
71702162|NCT04950686|142921192|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.086|TWO_SIDED||||||Mixed Models Analysis|||||||0.086
71702163|NCT04950686|142921192|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
71702164|NCT04950686|142921193|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.597|TWO_SIDED||||||Mixed Models Analysis|||||||0.597
71823369|NCT00924560|143149822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.24|-0.39|
71642108|NCT04994535|142802963|SUPERIORITY||Difference (%)|35.9|||<|0.0001|TWO_SIDED|95.0|27.2|44.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||44.6|27.2|<0.0001
71642109|NCT04994535|142802964|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-5.8|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-3.7|-5.8|<0.0001
71642110|NCT04994535|142802965|SUPERIORITY||Difference (SE)|-4.9|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-6.0|-3.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-3.7|-6.0|<0.0001
71642111|NCT04994535|142802965|SUPERIORITY||Difference (SE)|-4.7|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.9|-3.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.6|-5.9|<0.0001
71642112|NCT04994535|142802965|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
71642113|NCT00905840|142802998|NON_INFERIORITY_OR_EQUIVALENCE|The analysis of the primary outcome variable, was based on a confirmatory non-inferiority test with a one-sided 97.5% confidence interval. The non-inferiority margin for a clinically relevant difference was set at 0.1 mm. For a sample size of st least 73, a paired t-test with a 0.0025 one-sided significant level was calculated to have 80% power to reject the hypothesis that the test is inferior to the standard.|Mean Difference (Final Values)|0.1||||0.025|TWO_SIDED|97.5|0.1|0.3|||Student's t-test|||"Null hypothesis: Change of functional bone level at the test implant 12 month after surgery is more than 0.1 lower (inferior) than change of functional crestal bone level at the control implant 12 month after surgery.~H-1: Change of functional bone level at the tst implant 12 month after surgery is up to 0.1 lower, equal, or higher (not inferior) than change of functional crestal bone level at the control implant 12 month after surgery."||0.3|0.1|0.025
71642114|NCT00905840|142802999|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|95.0|||||McNemar|||This analysis is up to 12 month.||||0.1573
71642115|NCT00905840|142803000|SUPERIORITY_OR_OTHER|||||||0.3617|TWO_SIDED|||||12 month data Plaque index|Wilcoxon (Mann-Whitney)|||||||0.3617
71642116|NCT00905840|142803000|SUPERIORITY_OR_OTHER|||||||0.7068|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Plaque index||||||0.7068
71642117|NCT00905840|142803000|SUPERIORITY_OR_OTHER|||||||0.4312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Plaque Index||||||0.4312
71642118|NCT00905840|142803000|SUPERIORITY_OR_OTHER|||||||0.9933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|12 month data Sulcus Bleeding Index||||||0.9933
71642119|NCT00905840|142803000|SUPERIORITY_OR_OTHER|||||||0.3667|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|24 month data Sulcus Bleeding Index||||||0.3667
71642120|NCT00905840|142803000|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|36 month data Sulcus Bleeding Index||||||1.0000
71823370|NCT00924560|143149822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||||TWO_SIDED|95.0|-1.05|-0.42||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.42|-1.05|
71642121|NCT02115347|142803006|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.31|||||TWO_SIDED|90.0|68.01|112.08|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.08|68.01|
71642122|NCT02115347|142803007|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|87.43|||||TWO_SIDED|90.0|68.11|112.22|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||112.22|68.11|
71642123|NCT02115347|142803008|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.81|||||TWO_SIDED|90.0|72.4|126.79|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.79|72.40|
71823371|NCT00924560|143149823|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
71642124|NCT02115347|142803009|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|95.92|||||TWO_SIDED|90.0|72.46|126.97|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||126.97|72.46|
71642125|NCT02115347|142803010|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|78.7|||||TWO_SIDED|90.0|65.74|94.23|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||94.23|65.74|
71642126|NCT02115347|142803011|SUPERIORITY_OR_OTHER||Ratio (Test/Reference) of Adjusted Means|86.52|||||TWO_SIDED|90.0|70.49|106.2|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals \[CIs\]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).|||106.20|70.49|
71642127|NCT02849457|142803016|SUPERIORITY||Mean Difference (Final Values)|-0.6565|STANDARD_ERROR_OF_MEAN|3.9332||0.8681|TWO_SIDED|95.0|-8.5567|7.2436|||Mixed Models Analysis|Adjusted for age (\<=7 vs \>7 months) at randomization and sex. Unstructured covariance used among 12 and 24 month outcomes.|Parameter represents estimated amount difference in group means. Negative value represents higher mean in placebo group.|||7.2436|-8.5567|0.8681
71642128|NCT02849457|142803017|SUPERIORITY|||||||0.7375|||||||Chi-squared|||||||0.7375
71642129|NCT02849457|142803018|SUPERIORITY||Hazard Ratio (HR)|0.593||||0.1174|TWO_SIDED|95.0|0.309|1.14|||Regression, Cox|Adjusted for age (\<=7 vs \>7 months) at randomization and sex.||||1.140|0.309|0.1174
71642130|NCT02849457|142803019|OTHER|Two-sided test of non-equivalence||||||0.4653|||||||Chi-squared|||||||0.4653
71642131|NCT02849457|142803020|SUPERIORITY||Mean Difference (Final Values)|-4.4392|STANDARD_ERROR_OF_MEAN|3.1889||0.1697|TWO_SIDED|95.0|-10.8346|1.9562|||Mixed Models Analysis|Adjusted for age at randomization (\<=7 vs \>7 months) and sex. Unstructured covariance used among 12, 24, and 36 month outcomes.|Pertains to the estimated difference in mean score between groups at study visit corresponding to 24 months of age.|||1.9562|-10.8346|0.1697
71823372|NCT00924560|143149823|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71642132|NCT03673670|142803032|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.021||||0.168|TWO_SIDED|95.0|0.991|1.052|||ANCOVA|||||1.052|0.991|0.168
71642133|NCT03673670|142803032|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|0.995||||0.731|TWO_SIDED|95.0|0.966|1.025|||ANCOVA|||||1.025|0.966|0.731
71642134|NCT03673670|142803033|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.115|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.115
71642135|NCT03673670|142803033|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.111|TWO_SIDED|95.0|0.994|1.055|||ANCOVA|||||1.055|0.994|0.111
71642136|NCT03673670|142803034|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.014||||0.303|TWO_SIDED|95.0|0.987|1.043|||ANCOVA|||||1.043|0.987|0.303
71642137|NCT03673670|142803035|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.027||||0.067|TWO_SIDED|95.0|0.998|1.057|||ANCOVA|||||1.057|0.998|0.067
71642138|NCT03673670|142803035|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.395|TWO_SIDED|95.0|0.984|1.042|||ANCOVA|||||1.042|0.984|0.395
71642139|NCT03673670|142803036|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.404|TWO_SIDED|95.0|0.984|1.039|||ANCOVA|||||1.039|0.984|0.404
71642140|NCT03673670|142803037|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.082||||0.001|TWO_SIDED|95.0|1.043|1.123|||ANCOVA|||||1.123|1.043|0.001
71642141|NCT03673670|142803037|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.061||||0.002|TWO_SIDED|95.0|1.023|1.101|||ANCOVA|||||1.101|1.023|0.002
71823373|NCT00924560|143149823|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.01|0.00|
71642142|NCT03673670|142803038|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.02||||0.096|TWO_SIDED|95.0|0.997|1.043|||ANCOVA|||||1.043|0.997|0.096
71642143|NCT03673670|142803038|OTHER|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.002||||0.862|TWO_SIDED|95.0|0.979|1.025|||ANCOVA|||||1.025|0.979|0.862
71642144|NCT03673670|142803039|OTHER||Median Difference (Final Values)|0.0||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.945
71642145|NCT03673670|142803039|OTHER||Median Difference (Final Values)|0.0||||0.501|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.501
71642146|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.728||||0.0008|TWO_SIDED|95.0|-4.219|-1.236|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||-1.236|-4.219|0.0008
71642147|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.325||||0.0021|TWO_SIDED|95.0|-3.735|-0.916|||ANCOVA|||Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.916|-3.735|0.0021
71642148|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.402||||0.0021|TWO_SIDED|95.0|-3.862|-0.942|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||-0.942|-3.862|0.0021
71642149|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.556||||0.0382|TWO_SIDED|95.0|0.09|3.021|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean||3.021|0.090|0.0382
71642150|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.958||||0.0132|TWO_SIDED|95.0|0.439|3.477|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean||3.477|0.439|0.0132
71642151|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.881||||0.0161|TWO_SIDED|95.0|0.373|3.389|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean||3.389|0.373|0.0161
71642152|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.592||||0.0001|TWO_SIDED|95.0|-5.162|-2.022|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.022|-5.162|0.0001
71642153|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||0|TWO_SIDED|95.0|-5.304|-2.337|||ANCOVA|||Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||-2.337|-5.304|0.0000
71642154|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.887||||0.0006|TWO_SIDED|95.0|-4.424|-1.35|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||-1.350|-4.424|0.0006
71642155|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.953||||0.0005|TWO_SIDED|95.0|1.411|4.496|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean||4.496|1.411|0.0005
71642156|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.725||||0.0015|TWO_SIDED|95.0|1.126|4.324|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean||4.324|1.126|0.0015
71642157|NCT00575159|142803089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.659||||0.0001|TWO_SIDED|95.0|2.071|5.246|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean||5.246|2.071|0.0001
71642158|NCT00556322|142803102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.7299|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7299
71642159|NCT00556322|142803105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6198|TWO_SIDED|95.0|0.72|1.21|||Log Rank|||Comparison of EGFR positive populations||1.21|0.72|0.6198
71642160|NCT00556322|142803105|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8398|TWO_SIDED|95.0|0.55|1.62|||Log Rank|||Comparison of EGFR negative populations||1.62|0.55|0.8398
71642161|NCT00556322|142803108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0885|TWO_SIDED|95.0|0.97|1.46|||Log Rank|||||1.46|0.97|0.0885
71642162|NCT00556322|142803111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.0662|TWO_SIDED|95.0|0.98|1.61|||Log Rank|||Comparison of EGFR positive populations||1.61|0.98|0.0662
71642163|NCT00556322|142803111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|95.0|0.61|1.69|||Log Rank|||Comparison of EGFR negative populations||1.69|0.61|0.9403
71642164|NCT00556322|142803113|SUPERIORITY_OR_OTHER||Difference in Response Rates|1.55||||0.5349|TWO_SIDED|95.0|-3.6|6.7||p-values are based on non-stratified analysis|Chi-squared||Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method|||6.7|-3.6|0.5349
71642165|NCT00556322|142803115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.1498|TWO_SIDED|95.0|0.93|1.59|||Log Rank|||||1.59|0.93|0.1498
71642166|NCT00556322|142803118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2202|TWO_SIDED|95.0|0.9|1.57|||Log Rank|||||1.57|0.90|0.2202
71642167|NCT00556322|142803121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.1063|TWO_SIDED|95.0|0.95|1.66|||Log Rank|||||1.66|0.95|0.1063
71642168|NCT03733444|142803123|SUPERIORITY||Least Squares (LS) Mean difference|2.8|STANDARD_ERROR_OF_MEAN|25.29||0.9123|TWO_SIDED|95.0|-46.9|52.4||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||52.4|-46.9|0.9123
71642169|NCT03733444|142803123|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|25.01||0.9456|TWO_SIDED|95.0|-47.4|50.8||P-value was based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||50.8|-47.4|0.9456
71642170|NCT03733444|142803124|SUPERIORITY||Odds Ratio (OR)|1.15||||0.5162|TWO_SIDED|95.0|0.76|1.74|||Regression, Logistic|||||1.74|0.76|0.5162
71642171|NCT03733444|142803124|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7566|TWO_SIDED|95.0|0.71|1.62|||Regression, Logistic|||||1.62|0.71|0.7566
71642172|NCT03733444|142803125|SUPERIORITY||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|1.2|3.85|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.85|1.20|
71642173|NCT03733444|142803125|SUPERIORITY||Hazard Ratio (HR)|1.69|||||TWO_SIDED|95.0|0.93|3.1|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first respiratory-related hospitalization.|||3.10|0.93|
71642174|NCT03733444|142803126|SUPERIORITY||LS Mean difference|-0.1||||0.937|TWO_SIDED|95.0|-3.2|3.0||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||3.0|-3.2|0.9370
71642175|NCT03733444|142803126|SUPERIORITY||LS Mean difference|-0.4||||0.8064|TWO_SIDED|95.0|-3.4|2.7||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|Mixed Models Analysis|||||2.7|-3.4|0.8064
71642176|NCT03733444|142803127|SUPERIORITY||LS Mean difference|2.9|STANDARD_ERROR_OF_MEAN|23.39|||TWO_SIDED|95.0|-41.1|46.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||46.8|-41.1|
71702165|NCT04950686|142921193|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.551|TWO_SIDED||||||Mixed Models Analysis|||||||0.551
71702166|NCT04950686|142921194|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.634|TWO_SIDED||||||Mixed Models Analysis|||||||0.634
71702167|NCT04950686|142921194|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.308|TWO_SIDED||||||Mixed Models Analysis|||||||0.308
71702168|NCT04950686|142921195|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.415|TWO_SIDED||||||Mixed Models Analysis|||||||0.415
71761975|NCT02105961|143025883|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.068|TWO_SIDED|95.0|0.65|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.068
71761976|NCT02105961|143025883|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.034|TWO_SIDED|95.0|0.65|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.65|0.034
71761977|NCT02105961|143025883|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period|||1.05|0.70|0.140
71761978|NCT02105961|143025883|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|TWO_SIDED|95.0|0.7|1.05||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.05|0.70|0.140
71761979|NCT02105961|143025884|SUPERIORITY||Hazard Ratio(Mepolizumab 100/Placebo)|0.82||||0.14|TWO_SIDED|95.0|0.64|1.04||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.140
71761980|NCT02105961|143025884|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.82||||0.103|TWO_SIDED|95.0|0.64|1.04||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.04|0.64|0.103
71761981|NCT02105961|143025884|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.14|TWO_SIDED|95.0|0.6|0.97||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.140
71761982|NCT02105961|143025884|SUPERIORITY||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.03|TWO_SIDED|95.0|0.6|0.97||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.97|0.60|0.030
71761983|NCT02105961|143025885|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.14|TWO_SIDED|95.0|0.35|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.140
71761984|NCT02105961|143025885|SUPERIORITY||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.042|TWO_SIDED|95.0|0.35|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||0.98|0.35|0.042
71761985|NCT02105961|143025885|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
71761986|NCT02105961|143025885|SUPERIORITY||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|TWO_SIDED|95.0|0.51|1.34||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)|||1.34|0.51|0.447
71642177|NCT03733444|142803127|SUPERIORITY||LS Mean difference|8.0|STANDARD_ERROR_OF_MEAN|22.16|||TWO_SIDED|95.0|-35.5|51.5|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||51.5|-35.5|
71642178|NCT03733444|142803128|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.94|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.94|0.90|
71642179|NCT03733444|142803128|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.72|1.56|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.56|0.72|
71642180|NCT03733444|142803129|SUPERIORITY||LS Mean difference|0.9|||||TWO_SIDED|95.0|-12.4|14.1|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||14.1|-12.4|
71642181|NCT03733444|142803129|SUPERIORITY||LS Mean difference|3.6|||||TWO_SIDED|95.0|-10.4|17.6|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||17.6|-10.4|
71642182|NCT03733444|142803130|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.01|2.35|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||2.35|1.01|
71642183|NCT03733444|142803130|SUPERIORITY||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.91|2.16|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all cause hospitalization.|||2.16|0.91|
71642184|NCT03733444|142803133|SUPERIORITY||Hazard Ratio (HR)|2.92|||||TWO_SIDED|95.0|1.04|8.14|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||8.14|1.04|
71642185|NCT03733444|142803133|SUPERIORITY||Hazard Ratio (HR)|1.68|||||TWO_SIDED|95.0|0.55|5.13|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||5.13|0.55|
71642186|NCT03733444|142803134|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.82|1.06|
71642187|NCT03733444|142803134|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.06|0.86|
71642188|NCT03733444|142803135|SUPERIORITY||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.06|4.82|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.82|1.06|
71642189|NCT03733444|142803135|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|95.0|0.86|4.06|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.06|0.86|
71642190|NCT03733444|142803136|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||3.31|1.20|
71642191|NCT03733444|142803136|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||2.54|0.88|
71642192|NCT03733444|142803137|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|1.2|3.31|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||3.31|1.20|
71642193|NCT03733444|142803137|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.88|2.54|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or respiratory-related hospitalizations.|||2.54|0.88|
71642194|NCT04813354|142803186|SUPERIORITY||Odds Ratio (OR)|0.11|||<|0.001|TWO_SIDED|95.0|0.01|0.4|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.40|0.01|<0.001
71642195|NCT04813354|142803188|OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.03|0.74|||Exact conditional logistic regression||Odds ratio between ELLIPTA DPI and BREEZHALER DPI was calculated using an exact conditional logistic regression model with participant as fixed strata, inhaler and period as fixed effects.|||0.74|0.03|0.005
71642196|NCT04813354|142803197|OTHER||Mean Difference (Final Values)|27.63|||<|0.001|TWO_SIDED|95.0|21.31|33.96|||Paired samples t-test|||||33.96|21.31|<0.001
71642197|NCT02964039|142803221|SUPERIORITY|||||||0.047||||||A priori threshold: 0.05|ANOVA|0.047 is the main effect of group from a 2-way ANOVA that also included time (p=0.77) as a within-subjects factor.||||||0.047
71642198|NCT02964039|142803222|SUPERIORITY|||||||0.16||||||A priori threshold: 0.05|ANOVA|0.16 is the main effect of group from a 2-way ANOVA that also included time (p=0.023) as a within-subjects factor.||||||0.16
71642199|NCT02964039|142803223|SUPERIORITY|||||||0.64||||||A priori threshold: 0.05|ANOVA|0.64 is the main effect of group from a 2-way ANOVA that also included time (p=0.024) as a within-subjects factor.||||||0.64
71642200|NCT02964039|142803224|SUPERIORITY|||||||0.92||||||A priori threshold: 0.92|ANOVA|0.92 is the main effect of group from a 2-way ANOVA that also included time (p=0.076) as a within-subjects factor.||||||0.92
71642201|NCT02964039|142803225|SUPERIORITY||||||>=|0.22||||||A priori threshold: 0.05|Mixed Models Analysis|We compared incident rates assuming a negative binomial distribution with leas squares means estimates predicted via generalized linear model.||||||>=0.22
71642202|NCT02964039|142803226|SUPERIORITY|||||||0.99||||||A priori threshold: 0.05|Chi-squared|||||||0.99
71702169|NCT04950686|142921195|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
71642203|NCT01172145|142803258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|4.86||0.181|TWO_SIDED|95.0|-16.86|3.4|||t-test, 2 sided|||||3.40|-16.86|0.181
71642204|NCT02354339|142803266|SUPERIORITY|||||||0.24||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Irvingia gabonensis group||||0.240
71642205|NCT02354339|142803266|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.850
71642206|NCT02354339|142803267|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Irvingia gabonensis group||||0.012
71642207|NCT02354339|142803267|SUPERIORITY|||||||0.391||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.391
71642208|NCT02354339|142803268|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Irvingia gabonensis group||||0.206
71642209|NCT02354339|142803268|SUPERIORITY|||||||0.721||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||0.721
71642210|NCT02354339|142803269|SUPERIORITY|||||||0.371||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Irvingia gabonensis group||||0.371
71642211|NCT02354339|142803269|SUPERIORITY|||||||0.238||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.238
71642212|NCT02354339|142803270|SUPERIORITY|||||||0.452||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Irvingia gabonensis group||||0.452
71642213|NCT02354339|142803270|SUPERIORITY|||||||0.801||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on placebo group||||0.801
71642214|NCT02354339|142803271|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on Irvingia gabonensis group||||0.005
71642215|NCT02354339|142803271|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference on placebo group||||0.752
71642216|NCT02354339|142803272|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Irvingia gabonensis group||||0.791
71642217|NCT02354339|142803272|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||0.910
71642218|NCT02354339|142803273|SUPERIORITY|||||||0.458||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Irvingia gabonensis group||||0.458
71642219|NCT02354339|142803273|SUPERIORITY|||||||0.953||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.953
71642220|NCT02354339|142803274|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Irvingia gabonensis group||||0.470
71642221|NCT02354339|142803274|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.807
71642222|NCT02354339|142803275|SUPERIORITY|||||||0.604||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on Irvingia gabonensis group||||0.604
71702170|NCT04950686|142921196|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.261|TWO_SIDED||||||Mixed Models Analysis|||||||0.261
71642223|NCT02354339|142803275|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of body weight on placebo group||||0.350
71642224|NCT02354339|142803276|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Irvingia gabonensis group||||0.727
71642225|NCT02354339|142803276|SUPERIORITY|||||||0.229||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.229
71642226|NCT02354339|142803277|SUPERIORITY|||||||0.151||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Irvingia gabonensis group||||0.151
71642227|NCT02354339|142803277|SUPERIORITY|||||||0.955||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.955
71642228|NCT02354339|142803278|SUPERIORITY|||||||0.35||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on Irvingia gabonensis group||||0.350
71761987|NCT02105961|143025886|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.447|TWO_SIDED|95.0|-4.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.447
71761988|NCT02105961|143025886|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.18|TWO_SIDED|95.0|-4.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-4.5|0.180
71761989|NCT02105961|143025886|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
71761990|NCT02105961|143025886|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|TWO_SIDED|95.0|-2.8|2.6||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.6|-2.8|0.926
71761991|NCT02105961|143025887|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.926|TWO_SIDED|95.0|-2.3|0.0||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.926
71761992|NCT02105961|143025887|SUPERIORITY||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.0|-2.3|0.055
71761993|NCT02105961|143025887|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.926|TWO_SIDED|95.0|-1.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.926
71761994|NCT02105961|143025887|SUPERIORITY||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.547|TWO_SIDED|95.0|-1.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.8|-1.5|0.547
71761995|NCT04154189|143025888|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0396|TWO_SIDED|95.0|0.27|1.08||One-sided P value|Log Rank||Hazard ratio was based on Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (less than \[\<\]18 years, more than or equal to \[\>=\]18 years) in interactive response technology (IRT). Efron method was used for ties.|||1.08|0.27|0.0396
71761996|NCT04154189|143025889|OTHER|Difference in PFS rates, and 2-sided 95% confidence intervals (CIs): CI and p-value constructed using the difference of the 2 Kaplan-Meier PFS rates (4 months) and the 2 corresponding Greenwood standard errors.|Difference in Percentage|10.2||||0.1683|TWO_SIDED|95.0|-10.6|31.1||One-sided P value|Kaplan-Meier Method|||||31.1|-10.6|0.1683
71642229|NCT02354339|142803278|SUPERIORITY|||||||0.47||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of LDL-c on placebo group||||0.470
71642230|NCT02354339|142803279|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Irvingia gabonensis group||||0.910
71761997|NCT04154189|143025891|OTHER||Hazard Ratio (HR)|0.93||||0.3924|TWO_SIDED|95.0|0.53|1.62||Nominal p-value from stratified log-rank test adjusted for the randomization stratification factor, that is, age.|Stratified Log-rank One-sided Test||Hazard ratio was based on a Cox Proportional Hazard Model including treatment group as a factor and stratified by Age (\<18 years, \>=18 years) in IRT. Efron method was used for ties.|||1.62|0.53|0.3924
71761998|NCT04154189|143025892|OTHER|Difference and 95% CI: difference of 2 Kaplan-Meier OS-1y rates and corresponding Greenwood standard errors.|Difference in Percentage|-22.9||||0.0352|TWO_SIDED|95.0|-47.6|1.9||One-sided P value|Kaplan Meier Method|||||1.9|-47.6|0.0352
71823374|NCT00924560|143149823|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|0.95|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71642231|NCT02354339|142803279|SUPERIORITY|||||||0.436||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.436
71642232|NCT02354339|142803280|SUPERIORITY|||||||0.989||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Irvingia gabonensis group||||0.989
71761999|NCT04154189|143025893|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|7.7|||||TWO_SIDED|95.0|-6.4|22.3||||||||22.3|-6.4|
71762000|NCT04154189|143025894|OTHER|Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\<18 and \>=18 years).|Difference in Percentage|5.2|||||TWO_SIDED|95.0|-10.3|20.0||||||||20.0|-10.3|
71762001|NCT01485172|143025915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.864|TWO_SIDED|95.0|-3.41|4.05||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.05|-3.41|0.864
71762002|NCT01485172|143025915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.539|TWO_SIDED|95.0|-3.61|1.9||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.90|-3.61|0.539
71823375|NCT00924560|143149824|SUPERIORITY_OR_OTHER||LS mean Difference|0.13|||||TWO_SIDED|95.0|-0.03|0.28||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.28|-0.03|
71702171|NCT04950686|142921196|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.369|TWO_SIDED||||||Mixed Models Analysis|||||||0.369
71702172|NCT04950686|142921197|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.124|TWO_SIDED||||||Mixed Models Analysis|||||||0.124
71702173|NCT04950686|142921197|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
71702174|NCT04950686|142921198|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.011
71702175|NCT04950686|142921198|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
71702176|NCT04950686|142921199|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.585|TWO_SIDED||||||Mixed Models Analysis|||||||0.585
71702177|NCT04950686|142921199|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.338|TWO_SIDED||||||Mixed Models Analysis|||||||0.338
71702178|NCT04950686|142921200|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.259|TWO_SIDED||||||Mixed Models Analysis|||||||0.259
71702179|NCT04950686|142921200|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.950
71762003|NCT01485172|143025915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.091|TWO_SIDED|95.0|-5.21|0.39||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.39|-5.21|0.091
71762004|NCT01485172|143025915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.124|TWO_SIDED|95.0|-4.93|0.6||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.60|-4.93|0.124
71762005|NCT01485172|143025915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.658|TWO_SIDED|95.0|-5.04|3.19||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||3.19|-5.04|0.658
71762006|NCT01485172|143025915|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.439
71762007|NCT01485172|143025915|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.177
71762008|NCT01485172|143025915|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.060
71762009|NCT01485172|143025915|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.047
71762010|NCT01485172|143025915|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA|||||||0.407
71762011|NCT01485172|143025916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.003||||0.397|TWO_SIDED|95.0|0.4|9.98|||Generalized Estimating Equations model|||||9.98|0.40|0.397
71762012|NCT01485172|143025916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.242||||0.131|TWO_SIDED|95.0|0.79|6.4|||Generalized Estimating Equations model|||||6.40|0.79|0.131
71762013|NCT01485172|143025916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.515||||0.018|TWO_SIDED|95.0|1.25|9.92|||Generalized Estimating Equations model|||||9.92|1.25|0.018
71642233|NCT02354339|142803280|SUPERIORITY|||||||0.949||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.949
71642234|NCT02354339|142803281|SUPERIORITY|||||||0.095||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Irvingia gabonensis group||||0.095
71642235|NCT02354339|142803281|SUPERIORITY|||||||0.401||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.401
71642236|NCT02354339|142803282|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Irvingia gabonensis group||||0.910
71642237|NCT02354339|142803282|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.791
71642238|NCT04870606|142803395|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0181|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0181
71642239|NCT04870606|142803396|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.1223|ONE_SIDED||||||Chi-squared|||||||0.1223
71642240|NCT04870606|142803397|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.0038|ONE_SIDED||||||t-test, 2 sided|||||||0.0038
71642241|NCT00859430|142803431|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|105.0||||||90.0|98.6|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|98.6|
71642242|NCT00859430|142803432|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|96.2|
71642243|NCT00859430|142803433|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|95.9|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|95.9|
71642244|NCT04115293|142803434|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.24|-0.95|||MMRM ANCOVA|||||-0.95|-3.24|<0.001
71642245|NCT04115293|142803435|SUPERIORITY||LS Mean Difference|-2.94|||<|0.001|TWO_SIDED|95.0|-4.39|-1.49|||MMRM ANCOVA|||||-1.49|-4.39|<0.001
71642246|NCT04115293|142803436|SUPERIORITY||LS Mean Difference|-3.2||||0.0023|TWO_SIDED|95.0|-5.24|-1.16|||MMRM ANCOVA|||||-1.16|-5.24|0.0023
71642247|NCT04115293|142803437|SUPERIORITY||LS Mean Difference|-2.49||||0.0128|TWO_SIDED|95.0|-4.45|-0.54|||MMRM ANCOVA|||||-0.54|-4.45|0.0128
71642248|NCT04115293|142803439|SUPERIORITY||Odds Ratio (OR)|2.608||||0.0885|TWO_SIDED|95.0|0.866|7.86|||Regression, Logistic|||||7.860|0.866|0.0885
71642249|NCT04115293|142803440|SUPERIORITY||Odds Ratio (OR)|3.184|||<|0.001|TWO_SIDED|95.0|1.662|6.101|||Regression, Logistic|||||6.101|1.662|<0.001
71642250|NCT04115293|142803441|SUPERIORITY||Odds Ratio (OR)|2.865||||0.0012|TWO_SIDED|95.0|1.518|5.409|||Regression, Logistic|||||5.409|1.518|0.0012
71642251|NCT02826694|142803478|OTHER|||||||0.168|||||||linear mixed effect model|||T3||||0.168
71642252|NCT02826694|142803478|OTHER|||||||0.026|||||||linear mixed effect model|||T4||||0.026
71642253|NCT00761813|142803480|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.63|1.09||||||||1.09|.63|
71642254|NCT00761813|142803481|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71642255|NCT02125461|142803482|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.65|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.65|0.42|<0.0001
71642256|NCT02125461|142803483|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.00251|TWO_SIDED|95.0|0.53|0.87|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.87|0.53|0.00251
71642257|NCT02125461|142803484|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.||||<0.001
71642258|NCT02125461|142803488|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.68|0.41|<0.0001
71642259|NCT02125461|142803489|SUPERIORITY|||||||0.005||||||P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.|z-test|The variance was estimated using the delta method and Greenwood's formula.||||||0.005
71642260|NCT02125461|142803490|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.||0.73|0.46|<0.0001
71642261|NCT02125461|142803491|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.664|TWO_SIDED|95.0|0.77|1.18||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.18|0.77|0.664
71660918|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.054||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.054
71762014|NCT01485172|143025916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.02||95.0|1.22|10.64|||Generalized Estimating Equations model|||||10.64|1.22|0.020
71642262|NCT02125461|142803492|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.522|TWO_SIDED|95.0|0.88|1.29||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.29|0.88|0.522
71642263|NCT02125461|142803492|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.74|1.12||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.12|0.74|0.380
71642264|NCT02125461|142803492|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.048|TWO_SIDED|95.0|0.56|1.0||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.00|0.56|0.048
71642265|NCT02125461|142803492|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.626|TWO_SIDED|95.0|0.75|1.19||Analysis performed using a stratified log rank test adjusting for age at randomization (\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.||1.19|0.75|0.626
71642266|NCT05630885|142803535|SUPERIORITY||Slope|0.984||||0.65|TWO_SIDED|95.0|0.916|1.056||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use. Analysis used multiple imputation for missing data.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel, adjusting for statin-use. The study was powered to detect a between-group difference of 0.046 in log10 MDS TBR (10% relative fold-change), assuming a null difference of 0 in log10 MDS TBR (a ratio of 1 in absolute-scale), a standard deviation of 0.065 of change in log10 TBR, and 75 evaluable participants.||1.056|0.916|0.65
71642267|NCT05630885|142803535|OTHER|Statistical test for interaction.||||||0.4||||||P-value for modification of the CVC treatment effect by subgroups defined by statin-use is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by statin-use at study entry (use versus no-use).||||0.40
71642268|NCT05630885|142803535|OTHER|Statistical test for interaction.||||||0.63||||||P-value for modification of the CVC treatment effect by subgroups defined by sex is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for sex (F vs M) and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by sex (female versus male).||||0.63
71642269|NCT05630885|142803535|OTHER|Statistical test for interaction.||||||0.71||||||P-value for modification of the CVC treatment effect by subgroups defined by race is presented. A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for race and its interaction with treatment. Analysis used multiple imputation for missing data.||Evaluates whether CVC, compared to placebo, changes arterial inflammation in the MDS of the index vessel differently by race (Black/African-American versus Non-Black/African-American).||||0.71
71642270|NCT05630885|142803536|SUPERIORITY||Slope|0.996||||0.91|TWO_SIDED|95.0|0.93|1.067||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.067|0.930|0.91
71642271|NCT05630885|142803536|SUPERIORITY||Slope|0.98||||0.64|TWO_SIDED|95.0|0.901|1.066||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the TBR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.066|0.901|0.64
71660919|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.95||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.950
71762015|NCT01485172|143025916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.679||||0.202|TWO_SIDED|95.0|0.59|12.16|||Generalized Estimating Equations model|||||12.16|0.59|0.202
71642272|NCT05630885|142803537|SUPERIORITY||Slope|1.01||||0.79|TWO_SIDED|95.0|0.939|1.087||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the aorta adjusting for statin-use.||1.087|0.939|0.79
71642273|NCT05630885|142803537|SUPERIORITY||Slope|1.017||||0.69|TWO_SIDED|95.0|0.935|1.106||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale and rounded to 3 decimal places. It reflects the relative geometric mean fold-change in the SUV from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes arterial inflammation in the right and left carotid arteries adjusting for statin-use.||1.106|0.935|0.69
71642274|NCT05630885|142803538|SUPERIORITY||Slope|2.5||||0.49|TWO_SIDED|95.0|-4.6|9.6||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in fasting glucose from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting glucose adjusting for statin-use.||9.6|-4.6|0.49
71642275|NCT05630885|142803539|SUPERIORITY||Slope|1.07||||0.62|TWO_SIDED|95.0|0.81|1.43||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in fasting insulin from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of fasting insulin adjusting for statin-use.||1.43|0.81|0.62
71642276|NCT05630885|142803539|SUPERIORITY||Slope|1.09||||0.61|TWO_SIDED|95.0|0.78|1.54||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in HOMA-IR from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of HOMA-IR adjusting for statin-use.||1.54|0.78|0.61
71642277|NCT05630885|142803540|SUPERIORITY||Slope|0.97||||0.91|TWO_SIDED|95.0|0.62|1.52||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in hsCRP from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of hsCRP adjusting for statin-use.||1.52|0.62|0.91
71642278|NCT05630885|142803540|SUPERIORITY||Slope|1.01||||0.94|TWO_SIDED|95.0|0.77|1.33||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in IL-6 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of IL-6 adjusted for statin-use.||1.33|0.77|0.94
71642279|NCT05630885|142803540|SUPERIORITY||Slope|4.74|||<|0.001|TWO_SIDED|95.0|3.89|5.77||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MCP-1 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MCP-1 adjusting for statin-use.||5.77|3.89|<0.001
71642280|NCT05630885|142803541|SUPERIORITY||Slope|-49.0||||0.38|TWO_SIDED|95.0|-158.0|60.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD14 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of sCD14 adjusting for statin-use.||60|-158|0.38
71642281|NCT05630885|142803541|SUPERIORITY||Slope|-6.3||||0.88|TWO_SIDED|95.0|-87.0|75.0||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Model adjusted for statin-use.|Estimate reflects the relative mean change in sCD163 from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of sCD163 adjusting for statin-use.||75|-87|0.88
71642282|NCT05630885|142803542|SUPERIORITY||Slope|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.12||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in MIP-1 beta from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes the levels of MIP-1 beta adjusting for statin-use.||2.12|1.28|<0.001
71642283|NCT05630885|142803542|SUPERIORITY||Slope|1.02||||0.85|TWO_SIDED|95.0|0.82|1.28||A-priori threshold for statistical significance is at p \< 0.05. No adjustments for multiple comparisons were done.|Regression, Linear|Outcome was log10-transformed. Model adjusted for statin-use.|Estimate obtained from regression on log10-transformed scale was back-transformed to the original scale. It reflects the relative geometric mean fold-change in RANTES from baseline for CVC compared to placebo.|Evaluates whether CVC, compared to placebo, changes levels of RANTES adjusting for statin-use.||1.28|0.82|0.85
71702180|NCT04950686|142921201|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
71762016|NCT01485172|143025917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.544||||0.662||95.0|0.22|10.84|||Generalized Estimating Equations model|||||10.84|0.22|0.662
71642284|NCT03466866|142803570|SUPERIORITY||Incidence rate ratio|0.67||||0.12|TWO_SIDED|95.0|0.42|1.07|||Poisson regression|We adjusted for stratification variables, sex, baseline MOCA, number of medical conditions, PSQ Communication, and PSQ General satisfaction.||We used Poisson regression to model the number of outcome events as a function of randomization assignment, adjusting for the stratification variables and using follow-up time as the offset term. We calculated estimates of annual rates of the primary outcome and the adjusted estimate of the rate ratio. We evaluated the primary hypothesis by testing the null hypothesis that the rate ratio for randomization assignment equals 1.||1.07|.42|.12
71642285|NCT03466866|142803571|SUPERIORITY|General Satisfaction|Mean Difference (Final Values)|0.11||||0.502|TWO_SIDED|95.0|-0.22|0.45|||Regression, Linear|||We modeled PSQ- scores as continuous variables to estimate average change over time by treatment group. We used mixed effects linear regression with fixed effects for time (baseline, and months 6 and 12), randomization assignment, and time by randomization interaction. A random intercept term and an appropriate covariance structure was used to account for correlation among repeated measurements.||.45|-.22|.502
71642286|NCT03466866|142803572|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.23|TWO_SIDED|95.0|0.16|0.69|||ANCOVA|||Analysis of covariance was performed with Number of Quality Metrics as the dependent variable, treatment arm as the main independent variable of interest and the stratification variables as adjusting variables.||.69|.16|.23
71642287|NCT03466866|142803573|SUPERIORITY||Mean Difference (Net)|4.45||||0.094|TWO_SIDED|95.0|-0.76|9.66|||Mixed Models Analysis|||We used mixed effects linear regression. Fixed effects included time (baseline, and months 6 and 12), randomization assignment, time by randomization interaction, and the three stratification variables. From the results of this model, we estimated the mean change from baseline to 6 months, 6 months to 12 months and baseline to 12 months within each treatment group. We then compared the change from baseline to 12 months between the two groups.||9.66|-.76|.094
71642288|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-1.09|||<|0.0001||95.0|-1.3|-0.88|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.88|-1.30|<0.0001
71642289|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.02|||<|0.0001||95.0|-0.19|0.15|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.15|-0.19|<0.0001
71642290|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.06|||<|0.0001||95.0|-1.27|-0.85|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.85|-1.27|<0.0001
71642291|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.01|||<|0.0001||95.0|-0.16|0.18|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.18|-0.16|<0.0001
71642292|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.78|||<|0.0001||95.0|-0.99|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-0.99|<0.0001
71642293|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.29||||0.1026||95.0|0.12|0.46|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.46|0.12|0.1026
71660920|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.555||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.555
71762017|NCT01485172|143025917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.485||||0.557|TWO_SIDED|95.0|0.4|5.55|||Generalized Estimating Equations model|||||5.55|0.40|0.557
71762018|NCT01485172|143025917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.347|TWO_SIDED|95.0|0.51|6.72|||Generalized Estimating Equations model|||||6.72|0.51|0.347
71762019|NCT01485172|143025917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.379|TWO_SIDED|95.0|0.49|6.38|||Generalized Estimating Equations model|||||6.38|0.49|0.379
71762020|NCT01485172|143025917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.194||||0.851|TWO_SIDED|95.0|0.19|7.63|||Generalized Estimating Equations model|||||7.63|0.19|0.851
71642294|NCT00318461|142803594|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.07|||<|0.0001||95.0|-1.28|-0.86|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.86|-1.28|<0.0001
71642295|NCT00318461|142803595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.29||||0.0016||95.0|-2.16|-0.41|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.41|-2.16|0.0016
71642296|NCT00318461|142803595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.75|||<|0.0001||95.0|-4.48|-3.01|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-3.01|-4.48|<0.0001
71642297|NCT00318461|142803595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.07||||0.0117||95.0|-1.94|-0.19|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.19|-1.94|0.0117
71642298|NCT00318461|142803595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.53|||<|0.0001||95.0|-4.27|-2.79|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.79|-4.27|<0.0001
71642299|NCT00318461|142803595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.8198||95.0|-1.15|0.6|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.60|-1.15|0.8198
71642300|NCT00318461|142803595|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.73|||<|0.0001||95.0|-3.47|-2.0|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.00|-3.47|<0.0001
71642301|NCT00318461|142803596|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.11||||0.0378||95.0|-2.18|-0.05|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.05|-2.18|0.0378
71642302|NCT00318461|142803596|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.61|||<|0.0001||95.0|-4.51|-2.72|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.72|-4.51|<0.0001
71642303|NCT00318461|142803596|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.23||||0.0185||95.0|-2.3|-0.16|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.16|-2.30|0.0185
71762021|NCT01485172|143025919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.54|TWO_SIDED|95.0|0.36|7.03|||Generalized Estimating Equations model|||||7.03|0.36|0.540
71762022|NCT01485172|143025919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.473||||0.494|TWO_SIDED|95.0|0.49|4.47|||Generalized Estimating Equations model|||||4.47|0.49|0.494
71762023|NCT01485172|143025919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.391||||0.115|TWO_SIDED|95.0|0.81|7.06|||Generalized Estimating Equations model|||||7.06|0.81|0.115
71642304|NCT00318461|142803596|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.73|||<|0.0001||95.0|-4.64|-2.83|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.83|-4.64|<0.0001
71642305|NCT00318461|142803596|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.27||||0.9069||95.0|-1.33|0.8|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.80|-1.33|0.9069
71642306|NCT00318461|142803596|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.77|||<|0.0001||95.0|-3.67|-1.87|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.87|-3.67|<0.0001
71642307|NCT00318461|142803597|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.09|||<|0.0001||95.0|-2.68|-1.5|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.50|-2.68|<0.0001
71642308|NCT00318461|142803597|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.38||||0.1845||95.0|-0.87|0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.11|-0.87|0.1845
71642309|NCT00318461|142803597|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.04|||<|0.0001||95.0|-2.63|-1.44|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.44|-2.63|<0.0001
71642310|NCT00318461|142803597|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.33||||0.3047||95.0|-0.82|0.17|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||0.17|-0.82|0.3047
71642311|NCT00318461|142803597|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.53|||<|0.0001||95.0|-2.12|-0.94|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.94|-2.12|<0.0001
71642312|NCT00318461|142803597|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.18||||0.8079||95.0|-0.32|0.67|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.67|-0.32|0.8079
71642313|NCT00318461|142803598|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.93|||<|0.0001||95.0|-2.58|-1.28|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.28|-2.58|<0.0001
71762024|NCT01485172|143025919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96||||0.045|TWO_SIDED|95.0|1.02|8.55|||Generalized Estimating Equations model|||||8.55|1.02|0.045
71762025|NCT01485172|143025919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506||||0.221|TWO_SIDED|95.0|0.58|10.9|||Generalized Estimating Equations model|||||10.90|0.58|0.221
71642314|NCT00318461|142803598|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.53||||0.0542||95.0|-1.08|0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.01|-1.08|0.0542
71642315|NCT00318461|142803598|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-1.30|-2.60|<0.0001
71642316|NCT00318461|142803598|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.55||||0.0451||95.0|-1.1|-0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.||-0.01|-1.10|0.0451
71642317|NCT00318461|142803598|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.55|||<|0.0001||95.0|-2.2|-0.9|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||-0.90|-2.20|<0.0001
71642318|NCT00318461|142803598|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.9006||95.0|-0.7|0.39|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.||0.39|-0.70|0.9006
71642319|NCT00318461|142803599|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.13||||0.8871||95.0|-0.62|0.36|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.36|-0.62|0.8871
71642320|NCT00318461|142803599|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.12||||0.8695||95.0|-0.51|0.27|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.27|-0.51|0.8695
71642321|NCT00318461|142803599|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.03||||0.9994||95.0|-0.46|0.52|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.52|-0.46|0.9994
71642322|NCT00318461|142803599|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.04||||0.9984||95.0|-0.35|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.35|0.9984
71762026|NCT01485172|143025920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.662|TWO_SIDED|95.0|-3.78|5.93||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.93|-3.78|0.662
71762027|NCT01485172|143025920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.621|TWO_SIDED|95.0|-4.63|2.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.77|-4.63|0.621
71762028|NCT01485172|143025920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.75||||0.15|TWO_SIDED|95.0|-6.5|1.01||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.01|-6.50|0.150
71762029|NCT01485172|143025920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74||||0.048|TWO_SIDED|95.0|-7.43|-0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.04|-7.43|0.048
71762030|NCT01485172|143025920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.715|TWO_SIDED|95.0|-6.32|4.35||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.35|-6.32|0.715
71642323|NCT00318461|142803599|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.6201||95.0|-0.28|0.7|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.70|-0.28|0.6201
71642324|NCT00318461|142803599|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.4831||95.0|-0.18|0.6|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.60|-0.18|0.4831
71642325|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.83|||<|0.0001||95.0|-1.07|-0.59|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.59|-1.07|<0.0001
71642326|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.08|||<|0.0001||95.0|-0.28|0.12|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.12|-0.28|<0.0001
71642327|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.81|||<|0.0001||95.0|-1.05|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.57|-1.05|<0.0001
71642328|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.07|||<|0.0001||95.0|-0.27|0.13|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.13|-0.27|<0.0001
71642329|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-0.61|||<|0.0001||95.0|-0.85|-0.37|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.37|-0.85|<0.0001
71642330|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.14||||0.0052||95.0|-0.06|0.34|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||0.34|-0.06|0.0052
71642331|NCT00318461|142803600|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.75|||<|0.0001||95.0|-0.99|-0.51|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.||-0.51|-0.99|<0.0001
71642332|NCT00318461|142803601|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.24||||0.5282||95.0|-0.74|0.26|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.74|0.5282
71660921|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.221||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.221
71642333|NCT00318461|142803601|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.7644||95.0|-0.55|0.25|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.25|-0.55|0.7644
71642334|NCT00318461|142803601|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.36||||0.2063||95.0|-0.86|0.14|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.86|0.2063
71642335|NCT00318461|142803601|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.2678||95.0|-0.68|0.12|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.12|-0.68|0.2678
71642336|NCT00318461|142803601|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.07||||0.9887||95.0|-0.57|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.43|-0.57|0.9887
71642337|NCT00318461|142803601|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.02||||0.9998||95.0|-0.38|0.42|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.42|-0.38|0.9998
71642338|NCT00318461|142803602|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.30|-2.60|<0.0001
71642339|NCT00318461|142803602|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.11||||0.967||95.0|-0.62|0.41|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.41|-0.62|0.9670
71642340|NCT00318461|142803602|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.72|||<|0.0001||95.0|-2.36|-1.07|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.07|-2.36|<0.0001
71642341|NCT00318461|142803602|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.13||||0.9368||95.0|-0.39|0.64|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.64|-0.39|0.9368
71660922|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.393||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.393
71762031|NCT01485172|143025921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.158|TWO_SIDED|95.0|-0.46|2.81||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.81|-0.46|0.158
71762032|NCT01485172|143025921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.446|TWO_SIDED|95.0|-1.71|0.76||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.76|-1.71|0.446
71762033|NCT01485172|143025921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.163|TWO_SIDED|95.0|-2.1|0.36||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.36|-2.10|0.163
71762034|NCT01485172|143025921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.117|TWO_SIDED|95.0|-2.27|0.25||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.25|-2.27|0.117
71642342|NCT00318461|142803602|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.06||||0.0003||95.0|-1.71|-0.42|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.42|-1.71|0.0003
71642343|NCT00318461|142803602|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.78||||0.0008||95.0|0.27|1.29|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.29|0.27|0.0008
71642344|NCT00318461|142803603|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.66|||<|0.0001||95.0|-2.37|-0.96|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.96|-2.37|<0.0001
71642345|NCT00318461|142803603|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.3||||0.5048||95.0|-0.86|0.26|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.26|-0.86|0.5048
71642346|NCT00318461|142803603|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.79|||<|0.0001||95.0|-2.49|-1.08|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-1.08|-2.49|<0.0001
71642347|NCT00318461|142803603|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.42||||0.2005||95.0|-0.98|0.14|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.14|-0.98|0.2005
71642348|NCT00318461|142803603|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.16||||0.0003||95.0|-1.86|-0.46|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||-0.46|-1.86|0.0003
71642349|NCT00318461|142803603|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.7871||95.0|-0.35|0.76|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||0.76|-0.35|0.7871
71642350|NCT00318461|142803604|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|27.75||||0.0031||95.0|7.83|47.67|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||47.67|7.83|0.0031
71660923|NCT03118570|142835400|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.385
71702181|NCT04950686|142921201|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.491|TWO_SIDED||||||Mixed Models Analysis|||||||0.491
71762035|NCT01485172|143025921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.456|TWO_SIDED|95.0|-2.67|1.2||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||1.20|-2.67|0.456
71762036|NCT01485172|143025922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.823|TWO_SIDED|95.0|-4.38|5.5||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||5.50|-4.38|0.823
71642351|NCT00318461|142803604|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|1.44||||0.9987||95.0|-15.03|17.9|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||17.90|-15.03|0.9987
71642352|NCT00318461|142803604|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|21.96||||0.0263||95.0|2.04|41.87|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||41.87|2.04|0.0263
71642353|NCT00318461|142803604|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.36||||0.9227||95.0|-20.94|12.22|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.22|-20.94|0.9227
71642354|NCT00318461|142803604|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|22.08||||0.0253||95.0|2.15|42.01|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||42.01|2.15|0.0253
71642355|NCT00318461|142803604|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.23||||0.9293||95.0|-20.78|12.31|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||12.31|-20.78|0.9293
71642356|NCT00318461|142803605|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|25.71||||0.8821||95.0|-69.84|121.26|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||121.26|-69.84|0.8821
71642357|NCT00318461|142803605|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|6.56||||0.9989||95.0|-72.66|85.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||85.79|-72.66|0.9989
71642358|NCT00318461|142803605|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|35.2||||0.7292||95.0|-60.33|130.72|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||130.72|-60.33|0.7292
71660924|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71762037|NCT01485172|143025922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.568|TWO_SIDED|95.0|-4.86|2.68||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||2.68|-4.86|0.568
71702182|NCT04950686|142921202|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.498|TWO_SIDED||||||Mixed Models Analysis|||||||0.498
71702183|NCT04950686|142921202|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.573|TWO_SIDED||||||Mixed Models Analysis|||||||0.573
71702184|NCT04950686|142921203|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.128|TWO_SIDED||||||Mixed Models Analysis|||||||0.128
71762038|NCT01485172|143025922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0.101|TWO_SIDED|95.0|-7.01|0.63||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.63|-7.01|0.101
71642359|NCT00318461|142803605|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|16.05||||0.9689||95.0|-63.69|95.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||95.79|-63.69|0.9689
71642360|NCT00318461|142803605|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|72.38||||0.1818||95.0|-23.15|167.9|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||167.90|-23.15|0.1818
71642361|NCT00318461|142803605|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|53.23||||0.2978||95.0|-26.3|132.76|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||132.76|-26.30|0.2978
71642362|NCT04134091|142803608|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71642363|NCT04134091|142803608|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71642364|NCT04134091|142803609|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71642365|NCT04134091|142803609|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71642366|NCT04134091|142803610|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71642367|NCT04134091|142803610|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
71762039|NCT01485172|143025922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94||||0.04|TWO_SIDED|95.0|-7.7|-0.18||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||-0.18|-7.70|0.040
71642368|NCT04134091|142803611|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71642369|NCT04134091|142803611|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71642370|NCT04134091|142803612|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71642371|NCT04134091|142803612|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71642372|NCT04134091|142803613|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||>0.05
71642373|NCT04134091|142803613|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Outcome Variable: Hepatocyte Ballooning Score||||<0.05
71642374|NCT04134091|142803613|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
71642375|NCT04134091|142803613|SUPERIORITY||||||>|0.05|||||||ANCOVA|||Outcome Variable: Lobular Inflammation Score||||>0.05
71642376|NCT04134091|142803613|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.01
71642377|NCT04134091|142803613|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Outcome Variable: Steatosis Score||||<0.001
71642378|NCT04134091|142803614|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71642379|NCT04134091|142803614|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71642380|NCT04134091|142803615|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71642381|NCT04134091|142803615|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71642382|NCT04134091|142803616|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71642383|NCT04134091|142803616|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71642384|NCT04134091|142803617|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71642385|NCT04134091|142803617|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71642386|NCT04134091|142803618|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71642387|NCT04134091|142803618|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71642388|NCT04134091|142803619|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: AST||||>0.05
71642389|NCT04134091|142803619|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: AST||||<0.01
71642390|NCT04134091|142803619|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALT||||>0.05
71642391|NCT04134091|142803619|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||Outcome Variable: ALT||||< 0.01
71642392|NCT04134091|142803619|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||>0.05
71642393|NCT04134091|142803619|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: ALP||||<0.05
71642394|NCT04134091|142803619|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||>0.05
71642395|NCT04134091|142803619|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Outcome Variable: GGT||||<0.05
71642396|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
71642397|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: Total cholesterol||||>0.05
71642398|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
71642399|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: LDL||||>0.05
71642400|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
71642401|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: HDL||||>0.05
71642402|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
71642403|NCT04134091|142803620|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||Outcome Variable: triglycerides||||>0.05
71762040|NCT01485172|143025922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.811|TWO_SIDED|95.0|-6.08|4.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||4.77|-6.08|0.811
71762041|NCT01485172|143025923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.102|TWO_SIDED|95.0|-0.86|0.08||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.08|-0.86|0.102
71642404|NCT00796653|142803621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.167|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.167|0.091|<0.0001
71642405|NCT00796653|142803621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.116|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.116|<0.0001
71642406|NCT00796653|142803621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.112|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.188|0.112|<0.0001
71642407|NCT00796653|142803622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.019||0.0055||95.0|0.015|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.090|0.015|0.0055
71642408|NCT00796653|142803622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|0.032|0.0003
71642409|NCT00796653|142803622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.027||95.0|0.005|0.08|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.080|0.005|0.0270
71642410|NCT00796653|142803623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.314||0.1999||95.0|-0.213|1.018|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.018|-0.213|0.1999
71642411|NCT00796653|142803623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.314||0.1818||95.0|-0.196|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.035|-0.196|0.1818
71642412|NCT00796653|142803623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.602|STANDARD_ERROR_OF_MEAN|0.316||0.0572||95.0|-0.019|1.222|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.222|-0.019|0.0572
71642413|NCT00796653|142803624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.349||0.0197||95.0|-5.796|-0.503|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.503|-5.796|0.0197
71642414|NCT00796653|142803624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.524|STANDARD_ERROR_OF_MEAN|1.354||0.0094||95.0|-6.18|-0.867|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.867|-6.180|0.0094
71642415|NCT00796653|142803624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.416|STANDARD_ERROR_OF_MEAN|1.365||0.2995||95.0|-4.093|1.261|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.261|-4.093|0.2995
71642416|NCT00796653|142803625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|STANDARD_ERROR_OF_MEAN|1.385||0.7995||95.0|-3.068|2.365|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||2.365|-3.068|0.7995
71642417|NCT00796653|142803625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.391||0.4336||95.0|-3.818|1.639|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.639|-3.818|0.4336
71642418|NCT00796653|142803625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|1.395||0.9365||95.0|-2.625|2.848|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.848|-2.625|0.9365
71642419|NCT00796653|142803626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.625|STANDARD_ERROR_OF_MEAN|1.333||0.0491||95.0|-5.241|-0.01|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.010|-5.241|0.0491
71642420|NCT00796653|142803626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.489|STANDARD_ERROR_OF_MEAN|1.341||0.0636||95.0|-5.119|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|-5.119|0.0636
71642421|NCT00796653|142803626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.158|STANDARD_ERROR_OF_MEAN|1.35||0.0194||95.0|-5.806|-0.511|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||-0.511|-5.806|0.0194
71642422|NCT00796653|142803627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034|TWO_SIDED|95.0|-4.751|-0.94|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 5 mcg minus placebo||-0.940|-4.751|0.0034
71762042|NCT01485172|143025923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.723|TWO_SIDED|95.0|-0.41|0.29||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.29|-0.41|0.723
71762043|NCT01485172|143025923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.084|TWO_SIDED|95.0|-0.66|0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.04|-0.66|0.084
71642423|NCT00796653|142803627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004|TWO_SIDED|95.0|-5.343|-1.525|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 10 mcg minus placebo||-1.525|-5.343|0.0004
71642424|NCT00796653|142803627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009|TWO_SIDED|95.0|-3.161|0.665|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Form 12 mcg minus placebo||0.665|-3.161|0.2009
71642425|NCT00796653|142803628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.123|<0.0001
71642426|NCT00796653|142803628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.193|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.157|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.157|<0.0001
71642427|NCT00796653|142803628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.199|0.126|<0.0001
71642428|NCT00796653|142803629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
71642429|NCT00796653|142803629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.228|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.228|0.155|<0.0001
71642430|NCT00796653|142803629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.148|0.221|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.221|0.148|<0.0001
71762044|NCT01485172|143025923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.697|TWO_SIDED|95.0|-0.42|0.28||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.28|-0.42|0.697
71642431|NCT00796653|142803630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.108|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.182|0.108|<0.0001
71642432|NCT00796653|142803630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.138|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.138|<0.0001
71642433|NCT00796653|142803630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.208|0.133|<0.0001
71642434|NCT00796653|142803631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.080|<0.0001
71642435|NCT00796653|142803631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.180|0.103|<0.0001
71642436|NCT00796653|142803631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.091|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.168|0.091|<0.0001
71642437|NCT00796653|142803632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.018||0.0002||95.0|0.033|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.033|0.0002
71642438|NCT00796653|142803632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.083|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.155|0.083|<0.0001
71642439|NCT00796653|142803632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.018||0.0071||95.0|0.013|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.013|0.0071
71762045|NCT01485172|143025923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.086|TWO_SIDED|95.0|-0.06|0.97||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis|||||0.97|-0.06|0.086
71642440|NCT00796653|142803633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.048|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|0.048|<0.0001
71762046|NCT01485172|143025924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.769||||0.733|TWO_SIDED|95.0|0.17|3.49|||Generalized Estimating Equations model|||||3.49|0.17|0.733
71762047|NCT01485172|143025924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.411||||0.519|TWO_SIDED|95.0|0.5|4.02|||Generalized Estimating Equations model|||||4.02|0.50|0.519
71642441|NCT00796653|142803633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.068|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.141|0.068|<0.0001
71642442|NCT00796653|142803633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018||0.0001||95.0|0.034|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.106|0.034|0.0001
71642443|NCT00796653|142803634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0017||95.0|0.022|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.022|0.0017
71642444|NCT00796653|142803634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.057|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.130|0.057|<0.0001
71642445|NCT00796653|142803634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.101|0.028|0.0005
71642446|NCT00796653|142803635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.0085||95.0|0.013|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.013|0.0085
71642447|NCT00796653|142803635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.049|<0.0001
71642448|NCT00796653|142803635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019||0.0067||95.0|0.014|0.088|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.088|0.014|0.0067
71642449|NCT00796653|142803636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.100|0.025|0.0012
71762048|NCT01485172|143025924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.204||||0.008|TWO_SIDED|95.0|1.46|12.07|||Generalized Estimating Equations model|||||12.07|1.46|0.008
71762049|NCT01485172|143025924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.001|TWO_SIDED|95.0|1.93|15.46|||Generalized Estimating Equations model|||||15.46|1.93|0.001
71642450|NCT00796653|142803636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.035|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.110|0.035|0.0002
71642451|NCT00796653|142803636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0117||95.0|0.011|0.086|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.086|0.011|0.0117
71642452|NCT00796653|142803637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0014||95.0|0.024|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.024|0.0014
71642453|NCT00796653|142803637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.047|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.122|0.047|<0.0001
71642454|NCT00796653|142803637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.019||0.0035||95.0|0.019|0.094|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.094|0.019|0.0035
71642455|NCT00796653|142803638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0228||95.0|0.006|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.082|0.006|0.0228
71642456|NCT00796653|142803638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.021|0.097|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.097|0.021|0.0024
71642457|NCT00796653|142803638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.019||0.0664||95.0|-0.002|0.074|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.074|-0.002|0.0664
71642458|NCT00796653|142803639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.122|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.199|0.122|<0.0001
71642459|NCT00796653|142803639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.14|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.216|0.140|<0.0001
71642460|NCT00796653|142803639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.115|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.191|0.115|<0.0001
71642461|NCT00796653|142803640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.13|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.130|<0.0001
71642462|NCT00796653|142803640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.143|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.220|0.143|<0.0001
71642463|NCT00796653|142803640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.137|<0.0001
71642464|NCT00796653|142803641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.103|<0.0001
71642465|NCT00796653|142803641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.129|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.129|<0.0001
71642466|NCT00796653|142803641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.125|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.203|0.125|<0.0001
71642467|NCT00796653|142803642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.084|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.163|0.084|<0.0001
71642468|NCT00796653|142803642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.112|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.191|0.112|<0.0001
71762050|NCT01485172|143025924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.281||||0.752|TWO_SIDED|95.0|0.27|5.98|||Generalized Estimating Equations model|||||5.98|0.27|0.752
71642469|NCT00796653|142803642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.104|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.183|0.104|<0.0001
71642470|NCT00796653|142803643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.071|0.152|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.152|0.071|<0.0001
71642471|NCT00796653|142803643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.086|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.086|<0.0001
71642472|NCT00796653|142803643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.078|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.158|0.078|<0.0001
71642473|NCT00796653|142803644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.162|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.162|<0.0001
71642474|NCT00796653|142803644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.182|<0.0001
71642475|NCT00796653|142803644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.198|0.334|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.334|0.198|<0.0001
71642476|NCT00796653|142803645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.182|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.320|0.182|<0.0001
71642477|NCT00796653|142803645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.18|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.180|<0.0001
71762051|NCT02283762|143025926|SUPERIORITY||Difference of LS means|-2.34||||0.0815|TWO_SIDED|95.0|-4.99|0.3|||MMRM (Method 1)|||||0.30|-4.99|0.0815
71762052|NCT02283762|143025927|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|%|0.2||||0.977|TWO_SIDED|95.0|-13.68|14.09|||Mantel Haenszel|||||14.09|-13.68|0.9770
71762053|NCT02283762|143025928|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.07||||0.3529|TWO_SIDED|95.0|-0.23|0.08|||MMRM (Method 1)|||change from baseline||0.08|-0.23|0.3529
71762054|NCT02283762|143025929|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.79||||0.0887|TWO_SIDED|95.0|-0.12|1.69|||MMRM (Method 1)|||Change from baseline||1.69|-0.12|0.0887
71762055|NCT02283762|143025930|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.83||||0.0241|TWO_SIDED|95.0|0.11|1.54|||MMRM (Method 1)|||Change from baseline||1.54|0.11|0.0241
71762056|NCT02283762|143025931|SUPERIORITY|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.2||||0.901|TWO_SIDED|95.0|-3.4|3.0|||MMRM (Method 1)|||change from baseline||3.00|-3.40|0.9010
71762057|NCT00202878|143025942|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.016|TWO_SIDED|95.0|0.887|0.988|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.988|0.887|0.016
71762058|NCT00202878|143025943|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.948||||0.035|TWO_SIDED|95.0|0.903|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.996|0.903|0.035
71762059|NCT00202878|143025944|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.912||||0.016|TWO_SIDED|95.0|0.847|0.983|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.|||0.983|0.847|0.016
71762060|NCT00202878|143025945|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.945||||0.035|TWO_SIDED|95.0|0.897|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment|Model includes events from randomization to last study visit.|||0.996|0.897|0.035
71762061|NCT02028208|143025955|OTHER|Concordance between 0.40 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.38|||||TWO_SIDED|95.0|0.08|0.67||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.67|0.08|
71762062|NCT02028208|143025955|OTHER|Concordance between 0.40 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.67|||||TWO_SIDED|95.0|0.35|0.99||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.99|0.35|
71762063|NCT02028208|143025955|OTHER|Concordance between 0.36 mg/cm2 mercury and 1.0% ammoniated mercury in petrolatum|Kappa statistic|0.46|||||TWO_SIDED|95.0|0.15|0.76||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.76|0.15|
71762064|NCT02028208|143025955|OTHER|Concordance between 0.36 mg/cm2 mercury and 0.5% elemental mercury in petrolatum|Kappa statistic|0.57|||||TWO_SIDED|95.0|0.21|0.93||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.93|0.21|
71762065|NCT02028208|143025955|OTHER|Concordance between 0.10 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.48|||||TWO_SIDED|95.0|0.05|0.9||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.90|0.05|
71762066|NCT02028208|143025955|OTHER|Concordance between 0.10 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.39|||||TWO_SIDED|95.0|0.1|0.68||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.68|0.10|
71762067|NCT02028208|143025955|OTHER||Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between 0.30 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum||1.00|0.50|
71762068|NCT02028208|143025955|OTHER|Concordance between 0.30 mg/cm2 palladium and 1.0% palladium chloride in petrolatum|Kappa statistic|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.39|-0.02|
71762069|NCT02028208|143025955|OTHER|Concordance between 0.60 mg/cm2 palladium and 3.0% sodium tetrachloropalladate in petrolatum|Kappa statistic|0.83|||||TWO_SIDED|95.0|0.5|1.0||||||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||1.00|0.50|
71762070|NCT02028208|143025955|OTHER||Kappa statistic|0.06|||||TWO_SIDED|95.0|-0.05|0.17||||Concordance between 0.60 mg/cm2 palladium and 1.0 palladium chloride in petrolatum||Concordance between Investigational and Reference Allergen presented for allergen doses which met the minimum criteria of 70% with positive reactions.||0.17|-0.05|
71762071|NCT03563183|143025960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine Group compared to Placebo Group.|Vaccine Efficacy rate|95.81|||<|0.0001|TWO_SIDED|95.0|91.58|98.22|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Non-Frail-HZ/su vs Non-Frail-Placebo groups.||98.22|91.58|<0.0001
71762072|NCT03563183|143025960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.4|||<|0.0001|TWO_SIDED|95.0|84.41|94.43|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Pre-Frail-HZ/su vs Pre-Frail-Placebo groups.||94.43|84.41|<0.0001
71762073|NCT03563183|143025960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.17|||<|0.0001|TWO_SIDED|95.0|75.36|96.65|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Frail-HZ/su vs Frail-Placebo groups.||96.65|75.36|<0.0001
71762074|NCT03563183|143025960|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|100.0||||0.069|TWO_SIDED|95.0|14.61|100.0|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Unknown-HZ/su vs Unknown-Placebo groups.||100|14.61|0.069
71762075|NCT03563183|143025961|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|98.6|||||TWO_SIDED|95.0|97.1|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|97.1|
71762076|NCT03563183|143025961|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|92.6|||||TWO_SIDED|95.0|86.6|98.7||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||98.7|86.6|
71762077|NCT03563183|143025961|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|85.2|||||TWO_SIDED|95.0|62.6|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.||100|62.6|
71762078|NCT03563183|143025961|OTHER|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|100.0||||||||||||||VE against the BOI due to confirmed HZ. The 95% Confidence Interval was not calculated as there were no subjects reported with a confirmed Zoster episode in the Unknown-HZ/su Group.||||
71762079|NCT00838513|143026039|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
71762080|NCT00838513|143026040|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
71762081|NCT00838513|143026041|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
71762082|NCT00838513|143026042|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
71762083|NCT00838513|143026043|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
71762084|NCT00838513|143026044|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71762085|NCT00838513|143026045|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
71762086|NCT00838513|143026046|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
71762087|NCT00838513|143026047|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
71762088|NCT00838513|143026048|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
71762089|NCT00838513|143026049|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
71762090|NCT00838513|143026050|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71762091|NCT00573144|143026086|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
71762092|NCT00573144|143026087|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
71762093|NCT00573144|143026088|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
71762094|NCT01056016|143026091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.4|||=|0.003|TWO_SIDED||||||t-test, 2 sided|||The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.||||=.003
71762095|NCT03001817|143026099|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71642478|NCT00796653|142803645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.350|0.212|<0.0001
71642479|NCT00796653|142803646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.159|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.159|<0.0001
71642480|NCT00796653|142803646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.177|0.317|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.317|0.177|<0.0001
71642481|NCT00796653|142803646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.205|0.345|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.345|0.205|<0.0001
71642482|NCT00796653|142803647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.128|0.27|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.270|0.128|<0.0001
71642483|NCT00796653|142803647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.142|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.283|0.142|<0.0001
71642484|NCT00796653|142803647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.17|0.312|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.312|0.170|<0.0001
71642485|NCT00796653|142803648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.146|0.29|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.290|0.146|<0.0001
71642486|NCT00796653|142803648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.166|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.166|<0.0001
71642487|NCT00796653|142803648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.292|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.292|0.148|<0.0001
71642488|NCT00796653|142803649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.035||0.0133||95.0|0.018|0.157|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.157|0.018|0.0133
71642489|NCT00796653|142803649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.073|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.073|<0.0001
71642490|NCT00796653|142803649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.035||0.0212||95.0|0.012|0.151|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.151|0.012|0.0212
71642491|NCT00796653|142803650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.036||0.0004||95.0|0.057|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.057|0.0004
71762096|NCT03001817|143026100|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762097|NCT03001817|143026101|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
71642492|NCT00796653|142803650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.036||0.0012||95.0|0.045|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.185|0.045|0.0012
71642493|NCT00796653|142803650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0056||95.0|0.029|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.169|0.029|0.0056
71642494|NCT00796653|142803651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.036||0.0045||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.032|0.0045
71642495|NCT00796653|142803651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.036||0.0046||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.173|0.032|0.0046
71762098|NCT03001817|143026102|SUPERIORITY|||||||0.5443|||||||Hodges-Lehmann method|||||||0.5443
71762099|NCT03001817|143026103|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann Method|||||||<0.0001
71762100|NCT03001817|143026104|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762101|NCT03001817|143026105|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762102|NCT03001817|143026106|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762103|NCT03001817|143026107|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762104|NCT03001817|143026108|SUPERIORITY|||||||0.4939|||||||Hodges-Lehmann method|||||||0.4939
71762105|NCT03001817|143026109|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71642496|NCT00796653|142803651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.036||0.0023||95.0|0.039|0.181|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.181|0.039|0.0023
71642497|NCT00796653|142803652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.037||0.0077||95.0|0.026|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.169|0.026|0.0077
71642498|NCT00796653|142803652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.036||0.0009||95.0|0.05|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.050|0.0009
71642499|NCT00796653|142803652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0339||95.0|0.006|0.149|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.149|0.006|0.0339
71642500|NCT00796653|142803653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.037||0.0718||95.0|-0.006|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.006|0.0718
71642501|NCT00796653|142803653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.037||0.0863||95.0|-0.009|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.135|-0.009|0.0863
71642502|NCT00796653|142803653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.2982||95.0|-0.034|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.111|-0.034|0.2982
71642503|NCT00796653|142803654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.019||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0190
71642504|NCT00796653|142803654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0601||95.0|-0.003|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.003|0.0601
71642505|NCT00796653|142803654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.037||0.2573||95.0|-0.031|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.115|-0.031|0.2573
71762106|NCT03001817|143026110|SUPERIORITY|||||||0.8371|||||||Hodges-Lehmann method|||||||0.8371
71642506|NCT00796653|142803655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.037||0.02||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.160|0.014|0.0200
71642507|NCT00796653|142803655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.047|0.0013
71762107|NCT03001817|143026111|SUPERIORITY|||||||0.3415|||||||Hodges-Lehmann method|||||||0.3415
71642508|NCT00796653|142803655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.037||0.1598||95.0|-0.021|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.126|-0.021|0.1598
71642509|NCT00796653|142803656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.038||0.0307||95.0|0.008|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.155|0.008|0.0307
71642510|NCT00796653|142803656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.038||0.0073||95.0|0.027|0.175|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.175|0.027|0.0073
71762108|NCT03001817|143026112|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762109|NCT03001817|143026113|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762110|NCT03001817|143026114|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762111|NCT03001817|143026115|SUPERIORITY|||||||0.7442|||||||Hodges-Lehmann method|||||||0.7442
71762112|NCT03001817|143026116|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762113|NCT03001817|143026117|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762114|NCT03001817|143026118|SUPERIORITY|||||||0.0374|||||||Hodges-Lehmann method|||||||0.0374
71762115|NCT03001817|143026119|SUPERIORITY|||||||0.7429|||||||Hodges-Lehmann method|||||||0.7429
71762116|NCT03001817|143026120|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762117|NCT03001817|143026121|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762118|NCT03001817|143026122|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762119|NCT03001817|143026123|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762120|NCT03001817|143026124|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762121|NCT03001817|143026125|SUPERIORITY|||||||0.3669|||||||Hodges-Lehmann method|||||||0.3669
71762122|NCT03001817|143026126|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762123|NCT03001817|143026127|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762124|NCT03001817|143026128|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762125|NCT03001817|143026129|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762126|NCT03001817|143026130|SUPERIORITY|||||||0.0509|||||||Hodges-Lehmann method|||||||0.0509
71762127|NCT03001817|143026131|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762128|NCT03001817|143026132|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762129|NCT03001817|143026133|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762130|NCT03001817|143026134|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762131|NCT03001817|143026135|SUPERIORITY|||||||0.0647|||||||Hodges-Lehmann method|||||||0.0647
71762132|NCT03001817|143026136|SUPERIORITY|||||||0.0007|||||||Hodges-Lehmann method|||||||0.0007
71762133|NCT03001817|143026137|SUPERIORITY|||||||0.1399|||||||Hodges-Lehmann method|||||||0.1399
71762134|NCT03001817|143026138|SUPERIORITY|||||||0.0122|||||||Hodges-Lehmann method|||||||0.0122
71762135|NCT03001817|143026139|SUPERIORITY|||||||0.0994|||||||Hodges-Lehmann method|||||||0.0994
71762136|NCT03001817|143026140|SUPERIORITY|||||||0.0904|||||||Hodges-Lehmann method|||||||0.0904
71762137|NCT03001817|143026141|SUPERIORITY|||||||0.4346|||||||non-parametric Hodges-Lehmann method|||||||0.4346
71762138|NCT03001817|143026142|SUPERIORITY|||||||0.1474|||||||non-parametric Hodges-Lehmann method|||||||0.1474
71762139|NCT03001817|143026143|SUPERIORITY|||||||0.0054|||||||non-parametric Hodges-Lehmann method|||||||0.0054
71762140|NCT03001817|143026144|SUPERIORITY|||||||0.0002|||||||Hodges-Lehmann method|||||||0.0002
71762141|NCT03001817|143026145|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762142|NCT03001817|143026146|SUPERIORITY|||||||0.0118|||||||Hodges-Lehmann method|||||||0.0118
71762143|NCT03001817|143026147|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762144|NCT03001817|143026148|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71762145|NCT03001817|143026149|SUPERIORITY|||||||0.2049|||||||Hodges-Lehmann method|||||||0.2049
71762146|NCT03001817|143026150|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762147|NCT03001817|143026151|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762148|NCT03001817|143026152|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762149|NCT03001817|143026153|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762150|NCT03001817|143026154|SUPERIORITY|||||||0.9117|||||||Hodges-Lehmann method|||||||0.9117
71762151|NCT03001817|143026155|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71762152|NCT00035932|143026214|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.14|||||TWO_SIDED|97.5|-0.09|0.37||||||||0.37|-0.09|
71762153|NCT00035932|143026214|NON_INFERIORITY_OR_EQUIVALENCE|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.31|||||TWO_SIDED|97.5|0.07|0.55||||||||0.55|0.07|
71762154|NCT00035932|143026215|SUPERIORITY_OR_OTHER||Treatment Difference|0.13|||||TWO_SIDED|95.0|-0.04|0.3||||||||0.30|-0.04|
71762155|NCT00035932|143026215|SUPERIORITY_OR_OTHER||Treatment Difference|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
71762156|NCT00035932|143026218|SUPERIORITY_OR_OTHER||Time-Averaged Difference|0.13|||||TWO_SIDED|97.5|-0.12|0.39||||||||0.39|-0.12|
71762157|NCT00035932|143026218|SUPERIORITY_OR_OTHER||Time-Averaged Distance|0.33|||||TWO_SIDED|97.5|0.07|0.6||||||||0.60|0.07|
71762158|NCT00035932|143026219|SUPERIORITY_OR_OTHER||Difference estimate|-0.5|||||TWO_SIDED|95.0|-13.3|12.3|||||ATV 300/RTV - LPV/RTV|Randomized participants||12.3|-13.3|
71762159|NCT00035932|143026220|SUPERIORITY_OR_OTHER||Difference Estimate|3.6|||||TWO_SIDED|95.0|-7.0|14.1||||||||14.1|-7.0|
71762160|NCT00035932|143026220|SUPERIORITY_OR_OTHER||Difference Estimate|-11.3|||||TWO_SIDED|95.0|-22.9|0.4||||||||0.4|-22.9|
71762161|NCT00035932|143026222|SUPERIORITY_OR_OTHER||Difference Estimate|-5.0|||||TWO_SIDED|95.0|-16.9|7.0||||||||7.0|-16.9|
71762162|NCT00035932|143026222|SUPERIORITY_OR_OTHER||Difference Estimate|-16.1|||||TWO_SIDED|95.0|-28.5|-3.7||||||||-3.7|-28.5|
71762163|NCT00035932|143026224|SUPERIORITY_OR_OTHER||Difference Estimate|0.4|||||TWO_SIDED|95.0|-12.5|13.2|||||ATV 300/RTV - LPV/RTV|||13.2|-12.5|
71762164|NCT00035932|143026225|SUPERIORITY_OR_OTHER||Difference Estimate|3.2|||||TWO_SIDED|95.0|-9.1|15.4||||||||15.4|-9.1|
71762165|NCT00035932|143026225|SUPERIORITY_OR_OTHER||Difference Estimate|-16.7|||||TWO_SIDED|95.0|-29.4|-4.0||||||||-4.0|-29.4|
71762166|NCT00035932|143026226|SUPERIORITY_OR_OTHER||Difference Estimate|-1.1|||||TWO_SIDED|95.0|-13.7|11.4||||||||11.4|-13.7|
71762167|NCT00035932|143026226|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-30.6|-5.3||||||||-5.3|-30.6|
71762168|NCT00035932|143026227|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.0|10.3|||Chi-squared, Corrected||ATV 300/RTV - LPV/RTV|||10.3|-15.0|
71762169|NCT00035932|143026228|SUPERIORITY_OR_OTHER||Difference Estimate|-2.3|||||TWO_SIDED|95.0|-14.6|10.0||||||||10.0|-14.6|
71762170|NCT00035932|143026228|SUPERIORITY_OR_OTHER||Difference Estimate|-18.9|||||TWO_SIDED|95.0|-30.7|-7.1||||||||-7.1|-30.7|
71762171|NCT00035932|143026229|SUPERIORITY_OR_OTHER||Difference Estimate|-6.4|||||TWO_SIDED|95.0|-18.7|5.8||||||||5.8|-18.7|
71762172|NCT00035932|143026229|SUPERIORITY_OR_OTHER||Difference Estimate|-17.9|||||TWO_SIDED|95.0|-29.9|-5.9||||||||-5.9|-29.9|
71762173|NCT00035932|143026231|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-18.4|||||TWO_SIDED|97.5|-44.3|7.5||||||||7.5|-44.3|
71762174|NCT00035932|143026231|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-44.9|||||TWO_SIDED|97.5|-74.5|-15.3||||||||-15.3|-74.5|
71762175|NCT00035932|143026232|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-17.5|||||TWO_SIDED|97.5|-45.6|10.6||||||||10.6|-45.6|
71762176|NCT00035932|143026232|SUPERIORITY_OR_OTHER||Time-Averaged Difference|-47.6|||||TWO_SIDED|97.5|-79.2|-16.1||||||||-16.1|-79.2|
71762177|NCT00035932|143026234|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and HIV RNA||||<0.05
71762178|NCT00035932|143026234|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between number of PI Mutations at baseline (\<4; \>=4) of ATV 400 mg / SQV and HIV RNA||||<0.05
71762179|NCT00035932|143026236|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
71762180|NCT00035932|143026236|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (\<10; \>=10) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
71762181|NCT00035932|143026236|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between # of PI Mutations at baseline (\<4; \>=4) of ATV 300 mg / RTV and CD4 Cell Count||||<0.05
71762182|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-10.9|||||TWO_SIDED|95.0|-15.5|-6.0||||||Total Cholesterol||-6.0|-15.5|
71762183|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-12.4|||||TWO_SIDED|95.0|-16.9|-7.6||||||Total Cholesterol||-7.6|-16.9|
71762184|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-6.7|||||TWO_SIDED|95.0|-13.6|0.7||||||HDL cholesterol||0.7|-13.6|
71762185|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-1.0|||||TWO_SIDED|95.0|-9.3|8.1||||||HDL Cholesterol||8.1|-9.3|
71762186|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-6.8|||||TWO_SIDED|95.0|-15.6|3.0||||||Fasting LDL Cholesterol||3.0|-15.6|
71762187|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-7.3|||||TWO_SIDED|95.0|-15.5|1.8||||||Fasting LDL Cholesterol||1.8|-15.5|
71762188|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-24.9|||||TWO_SIDED|95.0|-35.0|-13.2||||||Fasting Triglycerides||-13.2|-35.0|
71762189|NCT00035932|143026238|SUPERIORITY_OR_OTHER||Difference Estimate|-34.2|||||TWO_SIDED|95.0|-43.4|-23.4||||||Fasting Triglycerides||-23.4|-43.4|
71762190|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-12.1|||||TWO_SIDED|95.0|-17.0|-7.2||||||Total Cholesterol||-7.2|-17.0|
71762191|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-12.0|||||TWO_SIDED|95.0|-17.4|-6.5||||||Total Cholesterol||-6.5|-17.4|
71762192|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-4.4|||||TWO_SIDED|95.0|-12.4|3.5||||||HDL Cholesterol||3.5|-12.4|
71762193|NCT00035932|143026239|SUPERIORITY_OR_OTHER||DIfference Estimate|-0.8|||||TWO_SIDED|95.0|-11.0|9.3||||||HDL Cholesterol||9.3|-11.0|
71762194|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-8.9|||||TWO_SIDED|95.0|-19.0|1.2||||||Fasting LDL CHolesterol||1.2|-19.0|
71642511|NCT00796653|142803656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.038||0.3147||95.0|-0.036|0.112|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.112|-0.036|0.3147
71762195|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-7.4|||||TWO_SIDED|95.0|-17.7|3.0||||||Fasting LDL Cholesterol||3.0|-17.7|
71762196|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-29.6|||||TWO_SIDED|95.0|-41.6|-17.7||||||Fasting Triglycerides||-17.7|-41.6|
71762197|NCT00035932|143026239|SUPERIORITY_OR_OTHER||Difference Estimate|-38.4|||||TWO_SIDED|95.0|-49.7|-27.1||||||Fasting Triglycerides||-27.1|-49.7|
71762198|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-14.4|||||TWO_SIDED|95.0|-20.1|-8.3|||||ATV 300/RTV - LPV/RTV|Observed values, Total Cholesterol||-8.3|-20.1|
71762199|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-9.0|||||TWO_SIDED|95.0|-16.1|-1.3|||||ATV 400/SQV - LPV/RTV|observed values, total cholesterol||-1.3|-16.1|
71762200|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-11.0|||||TWO_SIDED|95.0|-19.9|-1.2|||||ATV 300/RTV - LPV/RTV|observed values, HDL cholesterol||-1.2|-19.9|
71762201|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-4.1|||||TWO_SIDED|95.0|-14.0|7.0|||||ATV 400/SQV - LPV/RTV|Observed values, HDL cholesterol||7.0|-14.0|
71762202|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-12.7|||||TWO_SIDED|95.0|-22.3|-1.8|||||ATV 300/RTV - LPV/RTV|observed cases, fasting LDL||-1.8|-22.3|
71762203|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-7.9|||||TWO_SIDED|95.0|-19.0|4.8|||||ATV 400/SQV - LPV/RTV|Observed Cases, Fasting LDL cholesterol||4.8|-19.0|
71762204|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-24.8|||||TWO_SIDED|95.0|-38.6|-8.0|||||ATV 300/RTV - LPV/RTV|observed cases, fasting triglycerides||-8.0|-38.6|
71762205|NCT00035932|143026240|SUPERIORITY_OR_OTHER||Difference Estimate|-19.8|||||TWO_SIDED|95.0|-36.5|1.3|||||ATV 400/SQV - LPV/RTV|observed cases, fasting triglycerides||1.3|-36.5|
71762206|NCT00035932|143026251|SUPERIORITY_OR_OTHER||time-averaged difference|0.14|||||TWO_SIDED|97.5|-0.13|0.41|||||ATV 300/RTV - LPV/RTV|overall||0.41|-0.13|
71762207|NCT00035932|143026251|SUPERIORITY_OR_OTHER||time-averaged difference|0.11|||||TWO_SIDED|97.5|-0.16|0.38|||||ATV 300/RTV - LPV/RTV|last observation carried forward||0.38|-0.16|
71762208|NCT02268175|143026259|SUPERIORITY|||||||0.151||||||1-sided|Fisher Exact|||The hypothesis was that treatment with ARM 1 will have a pCR/MRD rate of 35% compared with Arm 2 rate of 10%. Given 75 men randomized in 2:1 ratio to Arm 1 (N=50) or Arm 2 (N=25), there was 84% power to detect this difference, using Fisher's exact test with one-sided type I error of 0.1.||||0.151
71762209|NCT03530124|143026301|SUPERIORITY|The number of infants with ≥1 apneic event for each group and compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group (\< 28 weeks versus ≥ 28 weeks) to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.7||||0.0104|TWO_SIDED|95.0|1.27|5.73|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the primary objective.|||5.73|1.27|0.0104
71762210|NCT03530124|143026302|OTHER|The number of apnea events were compared using a linear regression model (assuming a Poisson distribution) with study site and gestational age group covariates to control for the randomization blocks.||||||0.11|||||||Regression, Linear|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.11
71642512|NCT00796653|142803657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.16|0.306|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.306|0.160|<0.0001
71642513|NCT00796653|142803657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.156|0.302|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.302|0.156|<0.0001
71642514|NCT00796653|142803657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.175|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.321|0.175|<0.0001
71642515|NCT00796653|142803658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.174|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.321|0.174|<0.0001
71642516|NCT00796653|142803658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.148|0.295|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.295|0.148|<0.0001
71642517|NCT00796653|142803658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.328|0.180|<0.0001
71762211|NCT03530124|143026303|OTHER|Average duration of apnea episodes between groups were compared using a mixed effects model with a random intercept for each infant with one or more events and study site and gestational age group as covariates to control for the randomization blocks.||||||0.36|||||||Mixed Effects Model|No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.||||||0.36
71762212|NCT03530124|143026304|SUPERIORITY|The proportion of infants requiring an increase in respiratory support for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea.|Odds Ratio (OR)|2.07||||0.3555|TWO_SIDED|95.0|0.59|7.23|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|||7.23|0.59|0.3555
71762213|NCT03530124|143026305|SUPERIORITY|The proportion of infants with ≥1 cardiorespiratory event using a Mantel-Haenszel statistic in at the two-sided alpha 0.05 level and corresponding 95% confidence interval.|Odds Ratio (OR)|0.89||||1|TWO_SIDED|95.0|0.29|2.77|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|Only Duke University had viable monitoring data to analyze this compound outcome objective.||2.77|0.29|1.0000
71762214|NCT03530124|143026306|SUPERIORITY||Odds Ratio (OR)|1.93||||1|TWO_SIDED|95.0|0.17|21.63|||Mantel Haenszel||No adjustments were made to the alpha level (two-sided alpha=0.05) for the secondary objectives.|The proportion of infants requiring positive pressure ventilation for each group were compared using a Mantel-Haenszel statistic in a stratified analysis by study site and gestational age group to control for the randomization blocks at the two-sided alpha 0.05 level and corresponding 95% confidence interval for the occurrence of apnea during the 48-hour monitoring period.||21.63|0.17|1.0000
71762215|NCT00356304|143026359|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<.05
71762216|NCT02260180|143026387|SUPERIORITY|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71762217|NCT02260180|143026387|SUPERIORITY||||||<|0.0001|||||||Chi-squared|2-tail alpha was set to 0.05 with no adjustment for multiple comparisons.||||||<0.0001
71642518|NCT00796653|142803659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.141|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.289|0.141|<0.0001
71642519|NCT00796653|142803659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.151|0.3|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.300|0.151|<0.0001
71642520|NCT00796653|142803659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.191|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.340|0.191|<0.0001
71642521|NCT00796653|142803660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.106|<0.0001
71642522|NCT00796653|142803660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.105|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.256|0.105|<0.0001
71762218|NCT02260180|143026388|SUPERIORITY||||||<|0.0001||||||No adjustment for multiple comparisons were made.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||||||<0.0001
71762219|NCT02260180|143026388|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons were conducted.|ANCOVA|Baseline PLA was the covariate. Comparisons were performed within the model using least-squares means and the common error term.||The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.||||<0.0001
71762220|NCT03860818|143026398|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Rate of inpatient hospitalization during study||||<.001
71642523|NCT00796653|142803660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.132|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.283|0.132|<0.0001
71642524|NCT00796653|142803661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.111|0.265|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.265|0.111|<0.0001
71642525|NCT00796653|142803661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.138|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.138|<0.0001
71642526|NCT00796653|142803661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.115|0.269|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.269|0.115|<0.0001
71642527|NCT00796653|142803662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.707|STANDARD_ERROR_OF_MEAN|4.435||0.0021|TWO_SIDED|95.0|5.004|22.411|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.411|5.004|0.0021
71642528|NCT00796653|142803662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.871|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|12.158|29.584|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||29.584|12.158|<0.0001
71642529|NCT00796653|142803662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.249|STANDARD_ERROR_OF_MEAN|4.454||0.0014|TWO_SIDED|95.0|5.506|22.991|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||22.991|5.506|0.0014
71702185|NCT04950686|142921203|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
71823376|NCT00924560|143149824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.11|-0.20|
71642530|NCT00796653|142803662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|4.463||0.0001|TWO_SIDED|95.0|8.64|26.16|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||26.160|8.640|0.0001
71642531|NCT00796653|142803662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.875|STANDARD_ERROR_OF_MEAN|4.444|<|0.0001|TWO_SIDED|95.0|14.153|31.596|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||31.596|14.153|<0.0001
71642532|NCT00796653|142803662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.816|STANDARD_ERROR_OF_MEAN|4.475||0.0004|TWO_SIDED|95.0|7.032|24.599|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||24.599|7.032|0.0004
71642533|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|STANDARD_ERROR_OF_MEAN|0.121||0.2057|TWO_SIDED|95.0|-0.391|-0.084|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.084|-0.391|0.2057
71642534|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.121||0.0284|TWO_SIDED|95.0|-0.504|-0.028|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.028|-0.504|0.0284
71642535|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.122||0.0685|TWO_SIDED|95.0|-0.461|0.017|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.017|-0.461|0.0685
71642536|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.152||0.0674|TWO_SIDED|95.0|-0.576|0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||0.020|-0.576|0.0674
71642537|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.365|STANDARD_ERROR_OF_MEAN|0.0163||0.0163|TWO_SIDED|95.0|-0.662|-0.067|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.067|-0.662|0.0163
71642538|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.153||0.0364|TWO_SIDED|95.0|-0.62|-0.02|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.020|-0.620|0.0364
71642539|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.254||0.0959|TWO_SIDED|95.0|-0.922|0.075|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.075|-0.922|0.0959
71823377|NCT00924560|143149824|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.34|-0.01|
71702186|NCT04950686|142921204|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.0001|STANDARD_ERROR_OF_MEAN|0.07||0.999|TWO_SIDED||||||Mixed Models Analysis|||||||0.999
71762221|NCT03860818|143026398|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
71762222|NCT03860818|143026399|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Statistical analysis applies to all rows.||||||<0.001
71762223|NCT03860818|143026400|SUPERIORITY|||||||0.9064|||||||Chi-squared|||||||0.9064
71702187|NCT04950686|142921204|EQUIVALENCE|This arm will receive Health Aware for Young Adults in between the pretest and posttest questionnaire. Health Aware for Young Adults is a web-based sexual and relationship health promotion program. The program contains the same health content as Media Aware for Young Adults but without the media literacy education components. The program is self-paced and includes four modules.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.638|TWO_SIDED||||||Mixed Models Analysis|||||||0.638
71702188|NCT04950686|142921205|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.841|TWO_SIDED||||||Mixed Models Analysis|||||||0.841
71702189|NCT04950686|142921205|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.08||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.270
71702190|NCT04950686|142921206|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.94|TWO_SIDED||||||Mixed Models Analysis|||||||0.940
71702191|NCT04950686|142921206|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.09||0.992|TWO_SIDED||||||Mixed Models Analysis|||||||0.992
71702192|NCT04950686|142921207|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.470
71702193|NCT04950686|142921207|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.130
71702194|NCT04950686|142921208|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.931|TWO_SIDED||||||Mixed Models Analysis|||||||0.931
71702195|NCT04950686|142921208|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.666|TWO_SIDED||||||Mixed Models Analysis|||||||0.666
71702196|NCT04950686|142921209|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.822|TWO_SIDED||||||Mixed Models Analysis|||||||0.822
71702197|NCT04950686|142921209|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.721|TWO_SIDED||||||Mixed Models Analysis|||||||0.721
71702198|NCT04950686|142921210|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.540
71702199|NCT04950686|142921210|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.06||0.956|TWO_SIDED||||||Mixed Models Analysis|||||||0.956
71702200|NCT04950686|142921211|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.175|TWO_SIDED||||||Mixed Models Analysis|||||||0.175
71702201|NCT04950686|142921211|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.136|TWO_SIDED||||||Mixed Models Analysis|||||||0.136
71702202|NCT04950686|142921212|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.829|TWO_SIDED||||||Mixed Models Analysis|||||||0.829
71702203|NCT04950686|142921212|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.748|TWO_SIDED||||||Mixed Models Analysis|||||||0.748
71762224|NCT03860818|143026401|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71642540|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.616|STANDARD_ERROR_OF_MEAN|0.254||0.0155|TWO_SIDED|95.0|-1.115|-0.117|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.117|-1.115|0.0155
71642541|NCT00796653|142803663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.256||0.0347|TWO_SIDED|95.0|-1.042|-0.039|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.039|-1.042|0.0347
71642542|NCT00796653|142803664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0164||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0164
71642543|NCT00796653|142803664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0196||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0196
71642544|NCT00796653|142803664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0041||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0041
71642545|NCT00796653|142803665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0388||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0388
71642546|NCT00796653|142803665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0038||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0038
71642547|NCT00796653|142803665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0053||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0053
71702204|NCT04950686|142921213|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.490
71642548|NCT00796653|142803666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0555||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.0555
71642549|NCT00796653|142803666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.4|0.0122
71642550|NCT00796653|142803666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0144||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.4|0.0144
71642551|NCT00796653|142803667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5707||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.5707
71642552|NCT00796653|142803667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0814||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0814
71642553|NCT00796653|142803667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7413||95.0|-0.2|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.2|-0.2|0.7413
71762225|NCT00505778|143026422|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|1.3||||0.5016|TWO_SIDED|95.0|-2.3|4.9|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.9|-2.3|0.5016
71642554|NCT00796653|142803668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|STANDARD_ERROR_OF_MEAN|0.305||0.1524||95.0|-0.162|1.036|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.036|-0.162|0.1524
71642555|NCT00796653|142803668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.706|STANDARD_ERROR_OF_MEAN|0.306||0.0211||95.0|0.106|1.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.307|0.106|0.0211
71642556|NCT00796653|142803668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.307||0.1314||95.0|-0.139|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.139|0.1314
71642557|NCT00796653|142803669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.662|STANDARD_ERROR_OF_MEAN|0.308||0.0319||95.0|0.057|1.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.267|0.057|0.0319
71642558|NCT00796653|142803669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.667|STANDARD_ERROR_OF_MEAN|0.31||0.0312||95.0|0.06|1.274|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.274|0.060|0.0312
71702205|NCT04950686|142921213|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.831|TWO_SIDED||||||Mixed Models Analysis|||||||0.831
71702206|NCT04950686|142921214|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.350
71702207|NCT04950686|142921214|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.235|TWO_SIDED||||||Mixed Models Analysis|||||||0.235
71702208|NCT04950686|142921215|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.682|TWO_SIDED||||||Mixed Models Analysis|||||||0.682
71702209|NCT04950686|142921215|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.373|TWO_SIDED||||||Mixed Models Analysis|||||||0.373
71702210|NCT04950686|142921216|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|1.25||||0.242|TWO_SIDED|95.0|0.24|6.63|||Mixed Models Analysis|||||6.63|0.24|0.242
71702211|NCT04950686|142921216|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.78||||0.207|TWO_SIDED|95.0|0.11|5.72|||Mixed Models Analysis|||||5.72|0.11|0.207
71702212|NCT04950686|142921217|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.88||||0.576|TWO_SIDED|95.0|0.51|1.52|||Mixed Models Analysis|||||1.52|0.51|0.576
71702213|NCT04950686|142921217|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
71702214|NCT04950686|142921218|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.87||||0.467|TWO_SIDED|95.0|0.22|3.45|||Mixed Models Analysis|||||3.45|0.22|0.467
71702215|NCT04950686|142921218|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Odds Ratio (OR)|0.97||||0.888|TWO_SIDED|95.0|0.46|2.03|||Mixed Models Analysis|||||2.03|0.46|0.888
71702216|NCT04950686|142921219|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
71702217|NCT04950686|142921219|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.432|TWO_SIDED||||||Mixed Models Analysis|||||||0.432
71702218|NCT04950686|142921220|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.031|TWO_SIDED||||||Mixed Models Analysis|||||||0.031
71702219|NCT04950686|142921220|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.794|TWO_SIDED||||||Mixed Models Analysis|||||||0.794
71702220|NCT04950686|142921221|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School ID was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED||||||Mixed Models Analysis|||||||0.277
71702221|NCT04950686|142921221|EQUIVALENCE|To examine intervention effects on primary outcomes, we used multilevel regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect. School identifier (ID) was included as a random intercept to adjust for data nesting.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.115|TWO_SIDED||||||Mixed Models Analysis|||||||0.115
71702222|NCT03421808|142921226|SUPERIORITY|||||||0.6|||||||Chi-squared|||For categorical clinical remission data we performed a chi-square test on the IIT and completer sample using Graph-Pad Prism.||||0.6
71642559|NCT00796653|142803669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.311||0.1777||95.0|-0.191|1.029|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.029|-0.191|0.1777
71702223|NCT06717399|142921235|OTHER|The number of participants (n=15) was calculated using an effect size of 0.89. This effect size was based on a randomized clinical trial utilizing a structured mindfulness meditation program on moderate sleep disturbances in older adults (Black et al. 2015). A power of 0.8 and a significance level of 0.05 was utilized to calculate the sample size, a minimum of 12 participants is required to demonstrate significance in this study. To account for 20% attrition total participants needed is 15.||||||0.00058|||||||t-test, 2 sided|||"Null Hypothesis:~● There will not be a change in sleep quality after participation in eight mindfulness meditation sessions as measured by the Pittsburgh Sleep Quality Index."||||0.00058
71702224|NCT06717399|142921236|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
71702225|NCT00177671|142921275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.97|STANDARD_DEVIATION|2.09||0.05|TWO_SIDED|95.0|1.0|4.41|||Log Rank|||We followed the intention to treat principle. We used Kaplan-Meier curves to quantify the percentage of participants who were free of depression recurrence over time. Cox proportional hazard models quantified hazard ratios comparing the 2 treatment groups.||4.41|1.00|.05
71702226|NCT02293499|142921277|SUPERIORITY||partial eta squared|0.003||||0.043|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.043
71702227|NCT02293499|142921277|SUPERIORITY||partial eta squared|0.21||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71702228|NCT02293499|142921277|SUPERIORITY||Sobel Statistic|2.4119||||0.0079|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on quality of life||||.0079
71702229|NCT02293499|142921277|SUPERIORITY||Sobel Statistic|2.1132||||0.0172|TWO_SIDED||||||Sobel|||Mediator analysis of ACQ Total score subscale on quality of life||||.0172
71702230|NCT02293499|142921278|SUPERIORITY||partial eta squared|0.001||||0.295|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||0.295
71702231|NCT02293499|142921278|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71702232|NCT02293499|142921279|SUPERIORITY||partial eta squared|0.002||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.140
71702233|NCT02293499|142921279|SUPERIORITY||partial eta squared|0.15||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71702234|NCT02293499|142921280|SUPERIORITY||partial eta squared|0.001||||0.268|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.268
71702235|NCT02293499|142921280|SUPERIORITY||partial eta squared|0.06||||0.14|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.14
71702236|NCT02293499|142921281|SUPERIORITY||partial eta squared|0.001||||0.238|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.238
71774892|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.44|STANDARD_ERROR_OF_MEAN|2.53||0.5703|TWO_SIDED|95.0|-6.42|3.54|||ANCOVA|||Baseline adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.54|-6.42|0.5703
71642560|NCT00796653|142803670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.425|STANDARD_ERROR_OF_MEAN|0.311||0.1714||95.0|-0.184|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.035|-0.184|0.1714
71762226|NCT00505778|143026423|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.8||||0.5426|TWO_SIDED|95.0|-1.8|3.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||3.5|-1.8|0.5426
71762227|NCT00505778|143026424|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.0||||0.977|TWO_SIDED|95.0|-4.6|4.7|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||4.7|-4.6|0.9770
71762228|NCT00505778|143026425|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4726|TWO_SIDED|95.0|0.762|1.796|||Log Rank|Stratified by prior Asacol dose Category||||1.796|0.762|0.4726
71762229|NCT00505778|143026426|SUPERIORITY_OR_OTHER||Difference BID-QD in Least Square Mean|-0.45||||0.1753|TWO_SIDED|95.0|-1.09|0.2|||ANOVA|ANOVA with prior Asacol dose category as factor.||||0.20|-1.09|0.1753
71762230|NCT00505778|143026427|NON_INFERIORITY_OR_EQUIVALENCE|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is \<10%, then non-inferiority of Asacol QD is claimed.|Difference BID-QD Remission Rates|3.6||||0.1557|TWO_SIDED|95.0|-1.3|8.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.||8.5|-1.3|0.1557
71762231|NCT05367492|143026429|SUPERIORITY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.0|14.1|||Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||14.1|3.0|<0.001
71762232|NCT05367492|143026429|SUPERIORITY||||||<|0.001||||||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the primary outcome measure. Effects were deemed significant for p\<0.05.|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
71762233|NCT05367492|143026430|SUPERIORITY||Odds Ratio (OR)|6.1|||<|0.001|TWO_SIDED|95.0|3.1|12.3||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||12.3|3.1|<0.001
71762234|NCT05367492|143026430|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
71762235|NCT05367492|143026431|SUPERIORITY||Odds Ratio (OR)|6.0||||0.001|TWO_SIDED|95.0|2.1|16.9||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Model fit to data from varenicline and placebo groups only, adjusted for sex and baseline E-cigarette Dependence Inventory score.|Adjusted odds ratio comparing varenicline (numerator) versus placebo (denominator).|||16.9|2.1|0.001
71762236|NCT05367492|143026431|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of five secondary analysis results (Varenicline vs Placebo comparisons of secondary abstinence outcomes, and omnibus tests of all three abstinence outcomes).|Regression, Logistic|Omnibus tests for any difference in abstinence rates across study groups, based on χ² Wald statistic and adjusted for sex and baseline ECDI score.||||||<0.001
71762237|NCT05367492|143026432|SUPERIORITY||Mean Difference (Net)|-1.88||||0.001|TWO_SIDED|95.0|-2.93|-0.83||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.83|-2.93|0.001
71762238|NCT05367492|143026432|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study group.||||||<0.001
71823378|NCT00924560|143149824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.32|0.03||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.03|-0.32|
71642561|NCT00796653|142803670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.492|STANDARD_ERROR_OF_MEAN|0.312||0.1142||95.0|-0.119|1.103|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.103|-0.119|0.1142
71642562|NCT00796653|142803670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|0.314||0.0888||95.0|-0.081|1.15|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.150|-0.081|0.0888
71642563|NCT00796653|142803671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.318||0.1235||95.0|-0.134|1.113|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.113|-0.134|0.1235
71642564|NCT00796653|142803671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.318||0.2666||95.0|-0.271|0.978|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.978|-0.271|0.2666
71642565|NCT00796653|142803671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.319||0.3335||95.0|-0.317|0.934|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.934|-0.317|0.3335
71762239|NCT05367492|143026433|SUPERIORITY||Mean Difference (Net)|-6.76|||<|0.001|TWO_SIDED|95.0|-9.08|-4.45||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-4.45|-9.08|<0.001
71762240|NCT05367492|143026433|SUPERIORITY||||||<|0.001||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus tests of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||<0.001
71642566|NCT00796653|142803672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.313|STANDARD_ERROR_OF_MEAN|0.32||0.3287||95.0|-0.315|0.941|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.941|-0.315|0.3287
71642567|NCT00796653|142803672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.481|STANDARD_ERROR_OF_MEAN|0.321||0.1341||95.0|-0.148|1.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.109|-0.148|0.1341
71642568|NCT00796653|142803672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.322||0.722||95.0|-0.516|0.745|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.745|-0.516|0.7220
71642569|NCT00796653|142803673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.397|STANDARD_ERROR_OF_MEAN|0.322||0.2176||95.0|-0.234|1.027|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.027|-0.234|0.2176
71642570|NCT00796653|142803673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|STANDARD_ERROR_OF_MEAN|0.323||0.0258||95.0|0.087|1.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.348|0.087|0.0258
71642571|NCT00796653|142803673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.323||0.6044||95.0|-0.466|0.8|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.800|-0.466|0.6044
71642572|NCT00796653|142803674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.802|STANDARD_ERROR_OF_MEAN|0.133||0.1946||95.0|0.58|1.111|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.111|0.580|0.1946
71642573|NCT00796653|142803674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|STANDARD_ERROR_OF_MEAN|0.141||0.4071||95.0|0.634|1.198|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.198|0.634|0.4071
71642574|NCT00796653|142803674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.922|STANDARD_ERROR_OF_MEAN|0.15||0.6404||95.0|0.67|1.267|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.267|0.670|0.6404
71642575|NCT00796653|142803675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.685|STANDARD_ERROR_OF_MEAN|0.249||0.2942||95.0|0.336|1.399|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.399|0.336|0.2942
71642576|NCT00796653|142803675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947|STANDARD_ERROR_OF_MEAN|0.316||0.8594||95.0|0.493|1.82|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.820|0.493|0.8594
71642577|NCT00796653|142803675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|STANDARD_ERROR_OF_MEAN|0.281||0.5466||95.0|0.405|1.593|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.593|0.405|0.5466
71642578|NCT00796653|142803676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807|STANDARD_ERROR_OF_MEAN|0.146||0.2494||95.0|0.566|1.15|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.150|0.566|0.2494
71642579|NCT00796653|142803676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791|STANDARD_ERROR_OF_MEAN|0.143||0.2006||95.0|0.555|1.126|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.126|0.555|0.2006
71642580|NCT00796653|142803676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903|STANDARD_ERROR_OF_MEAN|0.16||0.5795||95.0|0.637|1.279|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.279|0.637|0.5795
71642581|NCT00796653|142803677|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.785|STANDARD_ERROR_OF_MEAN|0.1342||0.1571||95.0|0.5613|1.0979|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0979|0.5613|0.1571
71642582|NCT00796653|142803677|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8631|STANDARD_ERROR_OF_MEAN|0.1451||0.3814||95.0|0.6205|1.2005|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2005|0.6205|0.3814
71642583|NCT00796653|142803677|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0631|STANDARD_ERROR_OF_MEAN|0.1748||0.7098||95.0|0.7699|1.468|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.4680|0.7699|0.7098
71642584|NCT00796653|142803678|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7925|STANDARD_ERROR_OF_MEAN|0.2952||0.5326||95.0|0.3814|1.6464|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6464|0.3814|0.5326
71642585|NCT00796653|142803678|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0078|STANDARD_ERROR_OF_MEAN|0.356||0.9824||95.0|0.5038|2.016|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0160|0.5038|0.9824
71642586|NCT00796653|142803678|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0403|STANDARD_ERROR_OF_MEAN|0.3681||0.9112||95.0|0.5194|2.0832|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||2.0832|0.5194|0.9112
71642587|NCT00796653|142803679|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.744|STANDARD_ERROR_OF_MEAN|0.1389||0.1136||95.0|0.5158|1.0733|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.0733|0.5158|0.1136
71642588|NCT00796653|142803679|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7842|STANDARD_ERROR_OF_MEAN|0.1449||0.1887||95.0|0.5456|1.1271|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1271|0.5456|0.1887
71642589|NCT00796653|142803679|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.9761|STANDARD_ERROR_OF_MEAN|0.1747||0.8925||95.0|0.6869|1.387|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.3870|0.6869|0.8925
71642590|NCT00796653|142803682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027|TWO_SIDED|95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
71660925|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71762241|NCT05367492|143026434|SUPERIORITY||Mean Difference (Net)|-1.78||||0.008|TWO_SIDED|95.0|-3.08|-0.48||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Varenicline vs Placebo comparisons of secondary inventory outcomes).|Regression, Linear|Models fit to data from varenicline and placebo groups only using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic trend of time.|Adjusted mean difference comparing varenicline versus placebo. Negative indicates larger mean in placebo.|||-0.48|-3.08|0.008
71823379|NCT00924560|143149825|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71642591|NCT00796653|142803682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203|TWO_SIDED|95.0|0.082|0.967|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
71642592|NCT00796653|142803682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166|TWO_SIDED|95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
71642593|NCT03393208|142803683|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LeastSquare(LS) Mean%|99.76|||||TWO_SIDED|90.0|92.84|107.2||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||107.20|92.84|
71642594|NCT03393208|142803683|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.67||||||90.0|91.25|106.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||106.69|91.25|
71642595|NCT03393208|142803684|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|99.62||||||90.0|92.69|106.77||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||106.77|92.69|
71642596|NCT03393208|142803684|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.5||||||90.0|93.72|109.92||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||109.92|93.72|
71642597|NCT03393208|142803685|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.0|||||TWO_SIDED|90.0|-0.25|0.25||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||0.25|-0.25|
71642598|NCT03393208|142803685|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.25||||||90.0|-0.25|0.5||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||0.50|-0.25|
71642599|NCT03393208|142803687|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.26||||||90.0|94.33|108.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state||108.69|94.33|
71642600|NCT03393208|142803687|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.17|||||TWO_SIDED|90.0|91.61|105.21||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state||105.21|91.61|
71642601|NCT01848938|142803700|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Linear Mixed Models analysis|||analysis between groups||||<0.001
71642602|NCT01848938|142803701|SUPERIORITY_OR_OTHER|||||||0.005|||||||Linear Mixed Models analysis|||analysis between groups||||0.005
71642603|NCT01848938|142803702|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.023
71642604|NCT01848938|142803704|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.001
71642605|NCT01848938|142803705|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
71642606|NCT00207090|142803708|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.912|||||TWO_SIDED|90.0|0.751|1.106||||||Two-way analyses of variance were performed on log-transformed values of Cmax. The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||1.106|0.751|
71642607|NCT00207090|142803709|SUPERIORITY_OR_OTHER_LEGACY||Point estimate|0.566|||||TWO_SIDED|90.0|0.482|0.664||||||Two-way analyses of variance were performed on log-transformed values of (AUC \[INF\]). The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.||0.664|0.482|
71642608|NCT00304187|142803736|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71642609|NCT00099047|142803738|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|0.05||0.23|TWO_SIDED||||||SAS version 8||36 evaluable patients randomized 1:1 to each treatment was planned in order to have \>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.|||||.23
71642610|NCT00651820|142803739|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Paired-Prentice Wilcoxon (PPW)|Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.||Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure||||<0.05
71642611|NCT00651820|142803740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
71642612|NCT00651820|142803740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments||||<0.05
71642613|NCT03374176|142803760|EQUIVALENCE||Mean Difference (Net)|0.05|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||chi-square|||<0.05
71642614|NCT01302548|142803764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0833|STANDARD_DEVIATION|0.8609||0.797|TWO_SIDED|95.0|-0.5738|0.7405||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 28||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||.7405|-.5738|.7970
71642615|NCT01302548|142803765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2364||||0.3575|TWO_SIDED|95.0|0.0239|2.3394||This is unadjusted.|Fisher Exact|Cell (1,1) Frequency (F) = 13||"Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."||2.3394|.0239|.3575
71762242|NCT05367492|143026434|SUPERIORITY|||||||0.02||||||Benjamini-Hochberg multiplicity correction applied to p-values reported across family of three secondary analysis results (Omnibus Wald test of secondary inventory outcomes).|Regression, Linear|Models fit using GEE, adjusted for sex, baseline ECDI and outcome score, and quadratic time. Omnibus Wald test of any difference across study groups.||||||0.02
71762243|NCT05367492|143026435|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
71642616|NCT01302548|142803766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|0.5477||0.5415|TWO_SIDED|95.0|-2.0659|1.2659||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 4||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power."||1.2659|-2.0659|.5415
71642617|NCT01237054|142803769|SUPERIORITY|||||||0.024||||||The reported p-value is representative of the difference in levels of Ang2 in both groups.|Wilcoxon rank sum test|||||||0.024
71642618|NCT01237054|142803769|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of G-CSF in both groups.|Wilcoxon rank sum test|||||||0.055
71642619|NCT01237054|142803769|SUPERIORITY|||||||0.055||||||The reported p-value is representative of the difference in levels of Follistatin in both groups.|Wilcoxon rank sum test|||||||0.055
71642620|NCT01237054|142803769|SUPERIORITY|||||||0.0098||||||The reported p-value is representative of the difference in levels of HGF in both groups.|Wilcoxon rank sum test|||||||0.0098
71642621|NCT01237054|142803769|SUPERIORITY|||||||0.02||||||The reported p-value is representative of the difference in levels of VEGF-A in both groups.|Wilcoxon rank sum test|||||||0.02
71642622|NCT01237054|142803770|OTHER|Other, trend test.||||||0.008|||||||Jonckheere-Terpstra test for trend|||||||0.008
71642623|NCT01237054|142803771|OTHER|Other, trend test.||||||0.15||||||The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.15
71642624|NCT01237054|142803771|OTHER|Other, trend test.||||||0.33||||||The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend|||||||0.33
71642625|NCT01237054|142803772|SUPERIORITY|||||||0.08|||||||Wilcoxon rank sum test|||||||0.08
71642626|NCT01237054|142803773|SUPERIORITY|||||||0.011|||||||Wilcoxon rank sum test|||||||0.011
71642627|NCT00520234|142803777|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Cochran-Mantel-Haenszel|APACHE II Stratified||||||0.14
71642628|NCT00950989|142803796|SUPERIORITY||Difference in response rate|3.2||||0.598|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.598
71642629|NCT00950989|142803796|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71642630|NCT00950989|142803796|SUPERIORITY||Difference in response rate|3.2||||0.635|TWO_SIDED|95.0|-9.0|15.4||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||15.4|-9.0|0.635
71642631|NCT00950989|142803796|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.740
71642632|NCT00950989|142803796|SUPERIORITY||Difference in response rate|-3.2||||0.572|TWO_SIDED|95.0|-14.1|7.8||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||7.8|-14.1|0.572
71642633|NCT00950989|142803796|SUPERIORITY|||||||0.572||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.572
71642634|NCT00950989|142803797|SUPERIORITY||Difference in response rates|-3.2||||0.728|TWO_SIDED|95.0|-20.4|14.0||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||14.0|-20.4|0.728
71642635|NCT00950989|142803797|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71642636|NCT00950989|142803797|SUPERIORITY||Difference in response rates|-6.3||||0.412|TWO_SIDED|95.0|-23.4|10.7||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||10.7|-23.4|0.412
71642637|NCT00950989|142803797|SUPERIORITY|||||||0.74||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedures|||||||0.740
71642638|NCT00950989|142803797|SUPERIORITY||Difference in response rates|3.2||||0.74|TWO_SIDED|95.0|-14.2|20.5||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||20.5|-14.2|0.740
71642639|NCT00950989|142803797|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71642640|NCT00950989|142803798|SUPERIORITY||Difference in response rates|0.0||||0.984|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.984
71642641|NCT00950989|142803798|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71642642|NCT00950989|142803798|SUPERIORITY||Difference in response rates|0.0||||0.993|TWO_SIDED|95.0|-6.1|6.1||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||6.1|-6.1|0.993
71642643|NCT00950989|142803798|SUPERIORITY|||||||0.993||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.993
71642644|NCT00950989|142803798|SUPERIORITY||Difference in response rates|-3.2||||0.159|TWO_SIDED|95.0|-7.5|1.2||P-value is nominal p-value without multiplicity adjustment based on Cochran-Mantel-Haenszel test adjusting for sex.|Cochran-Mantel-Haenszel|||||1.2|-7.5|0.159
71642645|NCT00950989|142803798|SUPERIORITY|||||||0.797||||||Adjusted p-value is based on a combination of sequential testing and the Hommel procedure to control the overall significance level for all the comparisons.|Sequential testing + Hommel procedure|||||||0.797
71762244|NCT05367492|143026435|SUPERIORITY|||||||0.083|||||||Fisher Exact|||||||0.083
71642646|NCT00950989|142803799|SUPERIORITY||LS Mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.459|TWO_SIDED|95.0|-0.7|0.3||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.3|-0.7|0.459
71642647|NCT00950989|142803799|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.906|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.906
71642648|NCT00950989|142803799|SUPERIORITY||LS mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.849|TWO_SIDED|95.0|-0.5|0.5||P-value is nominal without multiplicity adjustment based on ANCOVA model adjusting for sex and baseline DAS28 score.|ANCOVA|||||0.5|-0.5|0.849
71642649|NCT00424047|142803822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.001|TWO_SIDED|95.0|0.24|0.438|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)|||0.438|0.240|<0.001
71642650|NCT00424047|142803823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.105|TWO_SIDED|95.0|0.498|1.07|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)|||1.070|0.498|0.105
71762245|NCT03085797|143026437|SUPERIORITY||Difference in Medians|-0.73|||<|0.001|TWO_SIDED|95.0|-1.11|-0.34||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment,region,Baseline score,Baseline eosinophilcount(BEC). Par. with nasal surgery prior to Wk52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal|||-0.34|-1.11|<0.001
71762246|NCT03085797|143026438|SUPERIORITY||Difference in Medians|-3.14|||<|0.001|TWO_SIDED|95.0|-4.09|-2.18||p-Value was based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.18|-4.09|<0.001
71762247|NCT03085797|143026439|SUPERIORITY||Hazard Ratio (Mepolizumab/Placebo)|0.43||||0.003|TWO_SIDED|95.0|0.25|0.76||p-Value was based on Cox Proportional Hazards Model.|Cox Proportional Hazards Model||Analysis using a Cox Proportional Hazards Model with covariates of treatment, geographic region, Baseline total endoscopic score (centrally read), Baseline nasal obstruction VAS, Baseline BEC, number of previous surgeries (1, 2, \>2 as ordinal).|||0.76|0.25|0.003
71762248|NCT03085797|143026440|OTHER||Difference in Medians|-3.18||||0.003|TWO_SIDED|95.0|-4.1|-2.26||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-2.26|-4.10|0.003
71762249|NCT03085797|143026441|OTHER||Difference in Medians|-16.49||||0.003|TWO_SIDED|95.0|-23.57|-9.42||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wk 52/withdrew early with no nasal surgery assigned their worst observed score prior to nasal surgery/study withdrawal.|||-9.42|-23.57|0.003
71823380|NCT00924560|143149825|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||0.00|-0.01|
71823381|NCT00924560|143149825|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
71823382|NCT00924560|143149825|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||-0.00|-0.01|
71642651|NCT00424047|142803824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.302|TWO_SIDED|95.0|0.651|1.143|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.143|0.651|0.302
71642652|NCT00424047|142803825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
71642653|NCT00424047|142803826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test||||||<0.001
71642654|NCT00424047|142803829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.558||||0.021|TWO_SIDED|95.0|0.338|0.921|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).|||0.921|0.338|0.021
71642655|NCT00424047|142803830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.362|||<|0.001|TWO_SIDED|95.0|0.27|0.478||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.478|0.27|<0.001
71642656|NCT00424047|142803831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.166||||0.271|TWO_SIDED|95.0|0.887|1.532||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)|||1.532|0.887|0.271
71762250|NCT03085797|143026442|OTHER||Odds Ratio (OR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||p-Value was based on logistic regression model and is adjusted for multiplicity.|Regression, Logistic||Covariates: treatment group, geographic region, number of oral corticosteroids courses for NP in last 12 months(0,1,\>1 as ordinal), Baseline total endoscopic score(centrally read),Baseline nasal obstruction VAS score,log(e) Baseline eosinophil count.|||0.92|0.36|0.020
71823383|NCT00924560|143149826|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.48|||||TWO_SIDED|95.0|-23.57|12.61||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||12.61|-23.57|
71642657|NCT00424047|142803832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.135||||0.359|TWO_SIDED|95.0|0.866|1.486||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||1.486|0.866|0.359
71642658|NCT00424047|142803833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.032|TWO_SIDED|95.0|0.398|0.964|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)|||0.964|0.398|0.032
71642659|NCT03527485|142803840|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in ventral striatum (VS).||||||0.011|||||||ANOVA|||||||0.011
71642660|NCT03527485|142803840|EQUIVALENCE|Between-group comparisons of binding potential non displaceable (BPND) in Prefrontal cortex (PFC).||||||0.044|||||||ANOVA|||||||0.044
71642661|NCT00730691|142803841|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.843||0.255|TWO_SIDED|95.0|-2.62|0.69||This treatment arm is not in the pre-specified testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05) comparing each of the 3 doses of vortioxetine to placebo.||0.69|-2.62|0.255
71642662|NCT00730691|142803841|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.843||0.719|TWO_SIDED|95.0|-1.96|1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.35|-1.96|0.719
71642663|NCT00730691|142803841|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.848||0.642|TWO_SIDED|95.0|-2.06|1.27||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||1.27|-2.06|0.642
71642664|NCT00730691|142803841|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.869||0.003|TWO_SIDED|95.0|-4.3|-0.89|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.89|-4.30|0.003
71762251|NCT03085797|143026443|OTHER||Difference in Medians|-2.68||||0.02|TWO_SIDED|95.0|-3.44|-1.91||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-1.91|-3.44|0.020
71642665|NCT00730691|142803842|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.511||0.83|TWO_SIDED|95.0|-0.89|1.11|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.11|-0.89|0.830
71642666|NCT00730691|142803842|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.643|TWO_SIDED|95.0|-1.24|0.77||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.77|-1.24|0.643
71642667|NCT00730691|142803842|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.517||0.036|TWO_SIDED|95.0|-2.1|-0.07||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.07|-2.10|0.036
71642668|NCT00730691|142803842|SUPERIORITY_OR_OTHER||LS mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.527||0.004|TWO_SIDED|95.0|-2.58|-0.5|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.50|-2.58|0.004
71642669|NCT00730691|142803843|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.129||0.407|TWO_SIDED|95.0|-0.36|0.15|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.15|-0.36|0.407
71642670|NCT00730691|142803843|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.129||0.533|TWO_SIDED|95.0|-0.33|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.33|0.533
71642671|NCT00730691|142803843|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.491|TWO_SIDED|95.0|-0.34|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.17|-0.34|0.491
71642672|NCT00730691|142803843|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.133||0.001|TWO_SIDED|95.0|-0.7|-0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-0.17|-0.70|0.001
71642673|NCT00730691|142803844|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.765||0.652|TWO_SIDED|95.0|-1.16|1.85|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.85|-1.16|0.652
71642674|NCT00730691|142803844|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.754||0.511|TWO_SIDED|95.0|-1.98|0.98|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.98|-1.98|0.511
71642675|NCT00730691|142803844|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.736||0.204|TWO_SIDED|95.0|-2.38|0.51|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.51|-2.38|0.204
71823384|NCT00924560|143149826|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.55|||||TWO_SIDED|95.0|-25.65|10.55||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.55|-25.65|
71823385|NCT00924560|143149826|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.09|||||TWO_SIDED|95.0|-34.99|10.81||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||10.81|-34.99|
71823386|NCT00924560|143149826|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.17|||||TWO_SIDED|95.0|-44.08|1.74||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.||1.74|-44.08|
71823387|NCT02909101|143149877|SUPERIORITY|||||||0.039|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.039
71823388|NCT02909101|143149878|SUPERIORITY|||||||0.054|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.054
71823389|NCT02909101|143149879|OTHER|||||||0.744|||||||t-test, 2 sided|||To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.744
71823390|NCT02909101|143149880|OTHER|||||||0.719|||||||t-test, 2 sided|||To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.||||0.719
71823391|NCT02909101|143149881|SUPERIORITY|||||||0.337|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.337
71823392|NCT02909101|143149882|SUPERIORITY|||||||0.025|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.025
71823393|NCT02909101|143149883|SUPERIORITY|||||||0.133|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.||||0.133
71823394|NCT01290094|143149907|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
71823395|NCT01290094|143149908|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
71823396|NCT01290094|143149909|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.001
71823397|NCT01290094|143149910|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.056
71823398|NCT01290094|143149911|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
71823399|NCT01290094|143149911|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test|||||||<0.0005
71823400|NCT01290094|143149912|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED|||||Month 12: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||<0.0005
71823401|NCT01290094|143149912|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Month 24: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test|||||||0.027
71823402|NCT00929305|143149916|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71823403|NCT00929305|143149919|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71823404|NCT04091672|143149933|NON_INFERIORITY|"The one-sided 97.5% confidence interval (97.5% CI) was calculated for the difference (Control-RECELL) in percentages of subjects with confirmed treatment area closure.~The calculation used the normal approximation taking correlation into account. In order for the null hypothesis to be rejected and the non-inferiority of RECELL to be established, the upper limit of the 97.5% CI had to be less than 10%."||||||0.005|||||||1-sided z-test of proportions|alpha=0.025||||||.005
71823405|NCT04091672|143149934|SUPERIORITY|A geometric mean ratio (GMR of ratios) 95% CI with a lower bound exceeding 1 would indicate superiority of RECELL over Control with respect to this endpoint.||||||0.001|||||||GMR of ratios|||||||0.001
71823406|NCT02401529|143149950|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||||||0.033
71823407|NCT02401529|143149951|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
71823408|NCT02401529|143149952|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Chi-squared|||||||0.016
71823409|NCT02401529|143149953|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
71823410|NCT02401529|143149954|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||||||0.012
71823411|NCT02401529|143149955|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||0.024
71823412|NCT02401529|143149956|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
71823413|NCT02401529|143149957|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
71823414|NCT02401529|143149958|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||||||0.026
71823415|NCT02401529|143149959|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
71823416|NCT02054247|143150071|SUPERIORITY|||||||0.442|||||||ANOVA|||||||0.442
71823417|NCT02054247|143150072|SUPERIORITY|||||||0.083|||||||ANOVA|||||||0.083
71823418|NCT02054247|143150073|SUPERIORITY|||||||0.125|||||||ANOVA|||||||0.125
71642676|NCT00730691|142803844|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.781||0.001|TWO_SIDED|95.0|-4.1|-1.03|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.03|-4.10|0.001
71642677|NCT00730691|142803845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.75|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.750|0.709|0.641
71642678|NCT00730691|142803845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.016||||0.945|TWO_SIDED|95.0|0.643|1.605|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.605|0.643|0.945
71642679|NCT00730691|142803845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.114||||0.641|TWO_SIDED|95.0|0.709|1.749|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.749|0.709|0.641
71642680|NCT00730691|142803845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.427||||0.124|TWO_SIDED|95.0|0.907|2.246|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||2.246|0.907|0.124
71642681|NCT00730691|142803846|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.346||0.064|TWO_SIDED|95.0|-5.15|0.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.14|-5.15|0.064
71642682|NCT00730691|142803846|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|1.353||0.096|TWO_SIDED|95.0|-4.92|0.4|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||0.40|-4.92|0.096
71642683|NCT00730691|142803846|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.397||0.25|TWO_SIDED|95.0|-4.36|1.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||1.14|-4.36|0.250
71642684|NCT00730691|142803846|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.54|STANDARD_ERROR_OF_MEAN|1.425||0.002|TWO_SIDED|95.0|-7.34|-1.73|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||||-1.73|-7.34|0.002
71642685|NCT02554890|142803859|OTHER||expon. back transformed from LS means|0.7143|||<|0.0001|TWO_SIDED|95.0|0.6315|0.808||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.8080|0.6315|<.0001
71642686|NCT02554890|142803863|OTHER||exponentially back transformed from LS m|0.8487||||0.0011|TWO_SIDED|95.0|0.7694|0.9361|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||0.9361|0.7694|0.0011
71642687|NCT02554890|142803864|OTHER||expon. back transformed from LS means|1.6487|||<|0.0001|TWO_SIDED|95.0|1.4559|1.8669|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.8669|1.4559|<.0001
71642688|NCT02554890|142803865|OTHER||expon. back transformed from LS means|1.4186|||<|0.0001|TWO_SIDED|95.0|1.3248|1.519|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5190|1.3248|<.0001
71642689|NCT02554890|142803866|OTHER||expon. back transformed from LS means|1.4745|||<|0.0001|TWO_SIDED|95.0|1.3752|1.581|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril|||1.5810|1.3752|<.0001
71642690|NCT02554890|142803867|OTHER||expon. back transformed from LS means|0.7133|||<|0.0001|TWO_SIDED|95.0|0.6171|0.8245||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/Valsartan vs. Enalapril|||0.8245|0.6171|<.0001
71642691|NCT01521780|142803870|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0803|||||ONE_SIDED|90.0||0.1163||||||||0.1163||
71642692|NCT01521780|142803871|SUPERIORITY_OR_OTHER||Within subject coefficient of variation|0.0555|||||ONE_SIDED|90.0||0.0733||||||||0.0733||
71642693|NCT03043872|142803875|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0047|TWO_SIDED|95.0|0.591|0.909||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \<1 favors D + EP to be associated with a longer OS than EP.||0.909|0.591|0.0047
71642694|NCT03043872|142803876|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0032|TWO_SIDED|95.0|0.625|0.91||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP.||0.910|0.625|0.0032
71642695|NCT03043872|142803876|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0451|TWO_SIDED|95.0|0.682|0.995||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|"D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.~HR \<1 favors D + T + EP to be associated with a longer OS than EP."||0.995|0.682|0.0451
71660926|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 1||||< 0.001
71823419|NCT02054247|143150074|SUPERIORITY|||||||0.146|||||||ANOVA|||||||0.146
71823420|NCT01195675|143150075|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.69|1.87|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.87|-0.69|
71823421|NCT01195675|143150076|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-0.38|1.71|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||1.71|-0.38|
71823422|NCT01195675|143150077|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.23|0.93|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.93|-1.23|
71823423|NCT01195675|143150078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|90.0|10.73|14.11|||ANCOVA|Based on ANCOVA with terms for treatment, period, treatment sequence, baseline and subject within sequence.|Non-confirmatory testing. Mean difference = Moxifloxacin minus placebo.|||14.11|10.73|<0.0001
71823424|NCT01195675|143150079|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.34|4.67|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||4.67|-0.34|
71823425|NCT01195675|143150080|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.35|3.53|||Repeated measures analysis|Based on repeated measured analysis with terms for subject, baseline, period, treatment, time, baseline by time, period by time and treatment by time.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||3.53|-0.35|
71823426|NCT01195675|143150081|NON_INFERIORITY_OR_EQUIVALENCE|Empa vs placebo|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-1.39|0.94|||ANCOVA|Based on ANCOVA with terms for sequence, subjects within sequence, period, treatment and baseline.|Mean difference = Empa minus placebo|Non-inferiority margin: 10ms||0.94|-1.39|
71823427|NCT04730947|143150092|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
71823428|NCT04730947|143150093|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
71823429|NCT04730947|143150094|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71823430|NCT04730947|143150095|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
71823431|NCT04730947|143150096|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71823432|NCT04730947|143150097|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
71823433|NCT04730947|143150098|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71823434|NCT04730947|143150099|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
71823435|NCT04730947|143150100|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||||||0.136
71823436|NCT01450943|143150117|SUPERIORITY||Odds Ratio (OR)|2.712595||||0.0517|TWO_SIDED|95.0|0.9141|8.4839|||Fisher Exact|||||8.4839|0.9141|0.0517
71823437|NCT01450943|143150118|SUPERIORITY||Odds Ratio (OR)|0.812339||||0.7974|TWO_SIDED|95.0|0.2543|2.5224|||Fisher Exact|||||2.5224|0.2543|0.7974
71823438|NCT05153174|143150120|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.931|||||||t-test, 2 sided|||||||0.931
71823439|NCT05153174|143150121|EQUIVALENCE|p \< 0.05 to reject null hypothesis of equivalence||||||0.224|||||||t-test, 2 sided|||||||0.224
71823440|NCT00961805|143150123|SUPERIORITY_OR_OTHER||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA|||"Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique."||||<0.001
71823441|NCT00961805|143150124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
71823442|NCT00961805|143150125|SUPERIORITY_OR_OTHER||||||<|0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.003
71823443|NCT00961805|143150126|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.146
71823444|NCT00961805|143150127|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.131
71823445|NCT00961805|143150128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||<0.001
71823446|NCT00961805|143150129|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.580
71823447|NCT00961805|143150130|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.082
71823448|NCT00961805|143150131|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.055
71823449|NCT00961805|143150132|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.003
71823450|NCT00961805|143150133|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.021
71823451|NCT00961805|143150134|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.136
71823452|NCT00961805|143150135|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Differences in the behavior of the groups over time.|ANOVA|||||||0.009
71823453|NCT02949271|143150136|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71823454|NCT02949271|143150137|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71823455|NCT02949271|143150139|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71823456|NCT02949271|143150140|OTHER|||||||0.28|||||||Chi-squared|||||||0.28
71823457|NCT02949271|143150141|OTHER|||||||0.85|||||||Chi-squared|||||||0.85
71823458|NCT02949271|143150142|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71823459|NCT02949271|143150143|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71823460|NCT02949271|143150144|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
71823461|NCT02949271|143150146|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71823462|NCT05458102|143150159|OTHER||Geometric Least-squares Mean Ratio|560.0|||||TWO_SIDED|90.0|414.0|757.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||757|414|
71823463|NCT05458102|143150159|OTHER||Geometric Least-squares Mean Ratio|137.0|||||TWO_SIDED|90.0|99.5|189.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||189|99.5|
71762252|NCT03085797|143026444|OTHER||Difference in Medians|-0.37||||0.02|TWO_SIDED|95.0|-0.65|-0.08||p-Value was based on Wilcoxon rank-sum test and is adjusted for multiplicity.|Wilcoxon rank-sum test||Quantile regression with covariates: treatment, region, Baseline score, Baseline BEC. Par. with nasal surgery prior to Wks 49-52/withdrew early with no nasal surgery assigned their worst observed 4-wk mean prior to nasal surgery/study withdrawal.|||-0.08|-0.65|0.020
71762253|NCT01837823|143026457|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.231||||0.054|TWO_SIDED||||||Regression, Linear|||||||0.054
71823464|NCT05458102|143150160|OTHER||Geometric Least-squares Mean Ratio|433.0|||||TWO_SIDED|90.0|347.0|540.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||540|347|
71823465|NCT05458102|143150160|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|93.5|150.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||150|93.5|
71823466|NCT05458102|143150161|OTHER||Geometric Least-squares Mean Ratio|752.0|||||TWO_SIDED|90.0|525.0|1080.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||1080|525|
71823467|NCT05458102|143150161|OTHER||Geometric Least-squares Mean Ratio|118.0|||||TWO_SIDED|90.0|80.3|172.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||172|80.3|
71823468|NCT05458102|143150163|OTHER||Geometric Least-squares Mean Ratio|68.5|||||TWO_SIDED|90.0|45.5|103.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||103|45.5|
71823469|NCT05458102|143150163|OTHER||Geometric Least-squares Mean Ratio|65.4|||||TWO_SIDED|90.0|42.5|101.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||101|42.5|
71823470|NCT05458102|143150167|OTHER||Geometric Least-squares Mean Ratio|120.0|||||TWO_SIDED|90.0|104.0|138.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||138|104|
71823471|NCT05458102|143150167|OTHER||Geometric Least-squares Mean Ratio|111.0|||||TWO_SIDED|90.0|95.4|128.0|||||Parametric (normal theory) mixed-effects ANOVA model was fitted to the natural log-transformed values of the PK parameter under evaluation.|||128|95.4|
71823472|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|25.0||||0.456|TWO_SIDED|95.0|-41.0|91.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||91.0|-41.0|0.456
71823473|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|74.7||||0.033|TWO_SIDED|95.0|6.0|143.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||143.4|6.0|0.033
71823474|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|30.6||||0.295|TWO_SIDED|95.0|-26.8|88.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||88.0|-26.8|0.295
71823475|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|44.4||||0.188|TWO_SIDED|95.0|-21.8|110.6||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||110.6|-21.8|0.188
71823476|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|38.8||||0.187|TWO_SIDED|95.0|-18.9|96.5||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||96.5|-18.9|0.187
71823477|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.9||||0.801|TWO_SIDED|95.0|-77.8|60.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg|||60.1|-77.8|0.801
71823478|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|35.2||||0.233|TWO_SIDED|95.0|-22.7|93.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||93.1|-22.7|0.233
71823479|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|69.4||||0.003|TWO_SIDED|95.0|24.5|114.4|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||114.4|24.5|0.003
71823480|NCT01323660|143150184|SUPERIORITY_OR_OTHER||Least squares mean difference|65.8||||0.005|TWO_SIDED|95.0|20.3|111.3|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||111.3|20.3|0.005
71823481|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.086|0.203|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.203|0.086|<0.001
71823482|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.255|||<|0.001|TWO_SIDED|95.0|0.193|0.318|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.318|0.193|<0.001
71823483|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001||95.0|0.061|0.163|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.163|0.061|<0.001
71823484|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.041|0.157|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.157|0.041|<0.001
71823485|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.132|||<|0.001|TWO_SIDED|95.0|0.081|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.183|0.081|<0.001
71823486|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.006||||0.849|TWO_SIDED|95.0|-0.055|0.067|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.067|-0.055|0.849
71823487|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.15|||<|0.001|TWO_SIDED|95.0|0.098|0.201|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.201|0.098|<0.001
71762254|NCT01837823|143026458|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.074||||0.5|TWO_SIDED||||||Pearson correlation coefficient|||for minimum lumen area site||||0.50
71762255|NCT02914301|143026480|OTHER|We compared outcomes between study arms using t-tests for continuous outcomes.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71762256|NCT00926029|143026552|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71762257|NCT00926029|143026553|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71762258|NCT04173494|143026555|SUPERIORITY||Stratified Cochran-Mantel-Haenszel|15.67||||0.0095|TWO_SIDED|95.0|5.54|25.81|||Cochran-Mantel-Haenszel|||||25.81|5.54|0.0095
71762259|NCT04173494|143026556|NON_INFERIORITY|If the lower bound of the confidence interval (CI) is greater than 0, MMB was to be declared non-inferior to DAN.|Non-inferiority difference|13.58||||0.0116|TWO_SIDED|95.0|1.86|25.3|||Cochran-Mantel-Haenszel||Non-inferiority difference, defined as p(MMB) - (0.8) \*p(DAN) where p(MMB) is percentage of participants with TI status in MMB arm and p(DAN) is percentage of participants with TI status in DAN arm.|||25.30|1.86|0.0116
71762260|NCT04173494|143026557|OTHER||Stratified Cochran-Mantel-Haenszel|33.05|||<|0.0001|TWO_SIDED|95.0|22.59|43.51|||Cochran-Mantel-Haenszel|||||43.51|22.59|< 0.0001
71762261|NCT04173494|143026558|OTHER||Least Squares Mean Difference|-6.22||||0.0014|TWO_SIDED|95.0|-10.0|-2.43|||mixed model for repeated measures (MMRM)|||||-2.43|-10.0|0.0014
71762262|NCT04173494|143026559|OTHER||Stratified Cochran-Mantel-Haenszel|18.18||||0.0011|TWO_SIDED|95.0|9.77|26.59|||Cochran-Mantel-Haenszel|||||26.59|9.77|0.0011
71762263|NCT04173494|143026560|OTHER||Stratified Cochran-Mantel-Haenszel|17.2||||0.0012|TWO_SIDED|95.0|7.99|26.4|||Cochran-Mantel-Haenszel|||||26.40|7.99|0.0012
71762264|NCT04173494|143026561|OTHER||Stratified Cochran-Mantel-Haenszel|10.62||||0.1133|TWO_SIDED|95.0|-2.4|23.64|||Cochran-Mantel-Haenszel|||||23.64|-2.40|0.1133
71823488|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.243|||<|0.001|TWO_SIDED|95.0|0.202|0.284|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.284|0.202|<0.001
71823489|NCT01323660|143150185|SUPERIORITY_OR_OTHER||Least squares mean difference|0.261|||<|0.001|TWO_SIDED|95.0|0.22|0.303|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.303|0.220|<0.001
71886154|NCT00662792|143292979|SUPERIORITY||Difference of adjusted means|0.142|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.083|0.201|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.201|0.083|<.0001
71886155|NCT00662792|143292979|SUPERIORITY||Difference of adjusted means|-0.057|STANDARD_ERROR_OF_MEAN|0.03||0.0601|TWO_SIDED|95.0|-0.116|0.002|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.002|-0.116|0.0601
71762265|NCT04173494|143026564|OTHER||Hazard Ratio (HR)|0.556||||0.0006|TWO_SIDED|95.0|0.397|0.778|||Anderson & Gill proportional means model|||||0.778|0.397|0.0006
71762266|NCT04173494|143026565|OTHER||Stratified CMH|-8.26||||0.1602|TWO_SIDED|95.0|-20.18|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.18|0.1602
71762267|NCT04173494|143026566|OTHER||Stratified CMH|19.0||||0.0124|TWO_SIDED|95.0|4.68|33.32|||Cochran-Mantel-Haenszel||\>=1g/dL Increase in Hemoglobin response|||33.32|4.68|0.0124
71762268|NCT04173494|143026566|OTHER||Stratified CMH|15.68||||0.0282|TWO_SIDED|95.0|2.47|28.9|||Cochran-Mantel-Haenszel||\>=1.5g/dL Increase in Hemoglobin response|||28.90|2.47|0.0282
71762269|NCT04173494|143026566|OTHER||Stratified CMH|6.97||||0.2844|TWO_SIDED|95.0|-5.41|19.35|||Cochran-Mantel-Haenszel||\>=2g/dL Increase in Hemoglobin response|||19.35|-5.41|0.2844
71762270|NCT04173494|143026571|OTHER||Hazard Ratio (HR)|0.89||||0.6879|TWO_SIDED|95.0|0.504|1.572|||Log Rank|||||1.572|0.504|0.6879
71762271|NCT04173494|143026572|OTHER||Hazard Ratio (HR)|0.804||||0.432|TWO_SIDED|95.0|0.466|1.386|||Log Rank|||||1.386|0.466|0.4320
71762272|NCT04173494|143026573|OTHER||Least Squares Mean Difference|-0.71||||0.0513|TWO_SIDED|95.0|-1.42|0.0|||MMRM|||||0.00|-1.42|0.0513
71762273|NCT04173494|143026574|OTHER||Least Squares Mean Difference|-10.82||||0.0113|TWO_SIDED|95.0|-19.15|-2.48|||MMRM|||||-2.48|-19.15|0.0113
71762274|NCT04173494|143026575|OTHER||Least Squares Mean Difference|1.31||||0.357|TWO_SIDED|95.0|-1.49|4.11|||MMRM|||||4.11|-1.49|0.3570
71762275|NCT02474069|143026576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.087|TWO_SIDED|95.0|0.39|1.07|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.07|0.39|0.087
71762276|NCT02474069|143026577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.281|TWO_SIDED|95.0|0.43|1.28|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error||1.28|0.43|0.281
71762277|NCT03656380|143026588|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71762278|NCT03656380|143026589|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71762279|NCT03656380|143026590|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
71762280|NCT03656380|143026591|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71762281|NCT03656380|143026592|SUPERIORITY||||||<|0.001|||||||Chi-squared|||\<15 eos/hpf||||<0.001
71762282|NCT03656380|143026592|SUPERIORITY|||||||0.02|||||||Chi-squared|||≤6 eos/hpf||||0.02
71762283|NCT03656380|143026592|SUPERIORITY|||||||0.27|||||||Chi-squared|||≤1 eos/hpf||||0.27
71762284|NCT03656380|143026593|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71762285|NCT03656380|143026594|SUPERIORITY|||||||0.44|||||||ANCOVA|||||||0.44
71886156|NCT00662792|143292980|SUPERIORITY||Difference of adjusted means|-0.028|STANDARD_ERROR_OF_MEAN|0.031||0.3652|TWO_SIDED|95.0|-0.089|0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.033|-0.089|0.3652
71823490|NCT02851511|143150198|SUPERIORITY|tDCS vs. sham superiority with cognitive training will be tested based on the 320 participants who are assigned to the two cognitive training arms. The effects of tDCS on changes in NIH Toolbox Fluid Cognition Composite Score (NIHTB FCC) from baseline to 3-month follow-up are estimated by linear regression models, with missing outcomes predicted by regression models that include demographic and baseline characteristics.|Slope|0.33|STANDARD_ERROR_OF_MEAN|0.63|<|0.05|TWO_SIDED|95.0|-0.91|1.56||Formal statistical inference of the tDCS effect was based on the inverse-normal combination of two p-values, one from the Phase I data (N=42) and the other from the Phase II data (N=292).|Regression, Linear|||"Null hypothesis: The combination of cognitive training (12 weeks) and active stimulation (over the dorsolateral prefrontal cortex) will not lead to beneficial changes on the NIH Toolbox Cognition Battery.~The study is designed to have at least 90% power to detect a difference of effect size 0.42 between cognitive training+tDCS and cognitive training+sham, using a normal inverse combination test at one-sided 0.025 level."||1.56|-0.91|<0.05
71823491|NCT02584790|143150210|OTHER|||||||0.004|||||||Chi-squared|||2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual disease||||0.004
71823492|NCT00372567|143150229|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.484|2.235|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||No hypothesis tested.||2.235|0.484|
71823493|NCT00372567|143150230|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.818|||||TWO_SIDED|95.0|0.64|12.41|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||12.41|0.640|
71823494|NCT00372567|143150232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.027|||||TWO_SIDED|95.0|0.505|2.088|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.088|0.505|
71823495|NCT00372567|143150233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.308|||||TWO_SIDED|95.0|0.4|13.0|||Cochran-Mantel-Haenszel|Stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||13.0|0.4|
71823496|NCT00372567|143150236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.434|||||TWO_SIDED|95.0|1.057|11.15|||Cox Proportional Hazards Model|Model stratified by previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||11.15|1.057|
71823497|NCT00372567|143150237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.379|||||TWO_SIDED|95.0|0.1|2.3|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||2.3|0.1|
71823498|NCT00372567|143150238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.318|||||TWO_SIDED|95.0|0.5|3.8|||Cochran-Mantel-Haenszel|Stratified for previous imatinib treatment status (less than 6 months of treatment with imatinib and greater than or equal to 6 months).||||3.8|0.5|
71823499|NCT00958009|143150290|SUPERIORITY_OR_OTHER||mean positive response|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is \>0.50.|||0.93|0.80|
71823500|NCT00558753|143150292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71823501|NCT00558753|143150293|SUPERIORITY_OR_OTHER||Independence: Chi-squared|10.3||||0.0013||95.0|||||Chi-squared|||For 3 month followup on incidence of neuropathic pain.||||0.0013
71823502|NCT00558753|143150293|SUPERIORITY_OR_OTHER||Independence: Chi-squared|6.05||||0.0139|||||||Chi-squared|||For 6 month followup on incidence of neuropathic pain.||||0.0139
71823503|NCT00558753|143150294|SUPERIORITY_OR_OTHER||Slope|-4.2||||0.0133||95.0||||Test of condition(Placebo v Pregabalin) main effect.|Mixed Models Analysis|Mixed model with main effects and time by condition interaction.||Mixed model test of condition (Placebo v Pregabalin) main effect.||||0.0133
71823504|NCT00558753|143150294|SUPERIORITY_OR_OTHER||Interaction Slice F-value|1.04||||0.3097||95.0|||||Mixed Models Analysis|Mixed model test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||Test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||||0.3097
71823505|NCT00558753|143150294|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.1||||0.0247||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 2-day post surgery time point (Slice)||||0.0247
71823506|NCT00558753|143150294|SUPERIORITY_OR_OTHER||Interaction Slice F-value|3.11||||0.0786||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 3-day post surgery time point (Slice)||||0.0786
71823507|NCT00558753|143150294|SUPERIORITY_OR_OTHER||Interaction Slice F-value|5.04||||0.0254||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 30-day post surgery time point (Slice)||||0.0254
71823508|NCT04668144|143150321|NON_INFERIORITY|Under the assumption of 0 difference in mean PRU between groups and a common standard deviation of 50 PRU, a sample size of 22 patients per group would allow for the 95%CI to stay within ± 45 PRU with a 90% power and alpha=0.05. In line with previously reported investigations, 45 PRU was chosen for the noninferiority margin for the upper 95%CI limit of the difference.|Mean Difference (Final Values)|130.0|||||TWO_SIDED|95.0|85.0|176.0||p-value was not calculated for noninferiority analysis|ANCOVA|||The primary hypothesis of our study was that in patients receiving concomitant administration of cangrelor and prasugrel (experimental arm), platelet inhibition as assessed by PRU would be noninferior to patients receiving prasugrel only (active control)||176|85|
71823509|NCT01072929|143150341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0097|TWO_SIDED|95.0|-6.58|-0.92||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.92|-6.58|0.0097
71823510|NCT01072929|143150341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0385|TWO_SIDED|95.0|-5.71|-0.16||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||-0.16|-5.71|0.0385
71823511|NCT02487446|143150416|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL.|Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778||0.139|TWO_SIDED|95.0|-0.0269|0.0038||p-value unadjusted|Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|0.139
71823512|NCT02487446|143150417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0115|STANDARD_ERROR_OF_MEAN|0.00778|||TWO_SIDED|95.0|-0.0269|0.0038||||||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||0.0038|-0.0269|
71823513|NCT02487446|143150418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0153|STANDARD_ERROR_OF_MEAN|0.01062|||TWO_SIDED|95.0|-0.0361|0.0056||||||||0.0056|-0.0361|
71823514|NCT02487446|143150419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0051|STANDARD_ERROR_OF_MEAN|0.00806|||TWO_SIDED|95.0|-0.0108|0.0209||||||||0.0209|-0.0108|
71823515|NCT03194776|143150426|SUPERIORITY||Mean Difference (Final Values)|-17.74|||=|0.2612|TWO_SIDED|80.0|-38.03|2.55||P-value of \<= 0.2 was considered significant.|two-sided test|||Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.||2.55|-38.03|= 0.2612
71823516|NCT04438785|143150443|SUPERIORITY||Mean Difference (Final Values)|2.58|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the Apnea Hypopnea Index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||<0.001
71823517|NCT04438785|143150444|SUPERIORITY||Median Difference (Final Values)|-0.971||||0.003|TWO_SIDED||||||t-test, 2 sided|||Evaluate if the O2 desaturation index (ODI) from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.003
71823518|NCT04438785|143150445|SUPERIORITY||Mean Difference (Net)|-0.364||||0.001|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the IOPI tongue score from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
71823519|NCT04438785|143150446|SUPERIORITY||Median Difference (Final Values)|-1.131||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the IOPI lip score from the baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
71823520|NCT04438785|143150447|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the neck circumference from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
71823521|NCT04438785|143150448|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.92|ONE_SIDED||||||t-test, 2 sided|||Evaluate if the waist circumference from baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.92
71823522|NCT04438785|143150449|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.98|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the BMI from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.98
71823523|NCT04438785|143150450|SUPERIORITY||Median Difference (Final Values)|-1.23||||0.001|ONE_SIDED|95.0|||||t-test, 2 sided|||Evaluate if the Epworth Sleepiness Scale from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.001
71823524|NCT04438785|143150451|SUPERIORITY||Mean Difference (Net)|0.98||||0.22|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Evaluate if the Pittsburgh sleep quality index from Baseline and after three months in the Intervention Group showed statistical significant difference p\<0.05 .||||0.22
71823525|NCT04011033|143150452|OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.16|0.63|||Log Rank|||||0.63|0.16|<0.001
71823526|NCT04011033|143150454|OTHER||||||=|0.003|||||||Fisher Exact|||||||=0.003
71823527|NCT04011033|143150455|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71823528|NCT04011033|143150457|OTHER||Hazard Ratio (HR)|0.37|||=|0.001|TWO_SIDED|95.0|0.19|0.71|||Log Rank|||||0.71|0.19|=0.001
71823529|NCT00689104|143150460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41||||0.003|TWO_SIDED|95.0|-0.72|-0.09||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.09|-0.72|0.003
71823530|NCT00689104|143150460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29||||0.01|TWO_SIDED|95.0|-0.61|0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||0.03|-0.61|0.010
71823531|NCT00689104|143150460|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.11|TWO_SIDED|95.0|-0.42|0.21||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.21|-0.42|0.11
71886157|NCT00662792|143292980|SUPERIORITY||Difference of adjusted means|0.042|STANDARD_ERROR_OF_MEAN|0.031||0.1816|TWO_SIDED|95.0|-0.02|0.103|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.103|-0.020|0.1816
71702237|NCT02293499|142921281|SUPERIORITY||partial eta squared|0.03||||0.43|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.43
71823532|NCT00689104|143150461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.29||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.29|-0.90|<0.001
71702238|NCT02293499|142921281|SUPERIORITY||Slope|-0.203||||0.024|TWO_SIDED||||||Mixed Models Analysis|||||||.024
71762286|NCT00486291|143026604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.||-0.2|-0.9|0.0007
71660927|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.003||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.003
71762287|NCT00486291|143026605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.1|-4.9|||ANCOVA|||||-4.9|-8.1|<0.0001
71762288|NCT03051178|143026611|SUPERIORITY||||||<|0.01||||||All post-hoc comparisons were Bonferroni corrected.|ANOVA|||TRS scores measured across different stimulation conditions were assessed using a mixed model ANOVA with the participant as a random effect. All post-hoc comparisons were Bonferroni corrected.||||<0.01
71762289|NCT01388335|143026620|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.81|||||TWO_SIDED|90.0|0.691|0.95|||||Ratio of Geometric LS mean is for S-warfarin.|||0.950|0.691|
71762290|NCT01388335|143026620|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.912|||||TWO_SIDED|90.0|0.815|1.02|||||Ratio of Geometric LS mean is for R-warfarin.|||1.02|0.815|
71762291|NCT01388335|143026621|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.98|||||TWO_SIDED|90.0|0.76|3.5|||||Median Difference (Final Values) is for S-warfarin.|||3.50|0.76|
71762292|NCT01388335|143026621|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|-1.0|6.84|||||Median Difference (Final Values) is for R-warfarin.|||6.84|-1.00|
71762293|NCT01388335|143026622|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.28|||||TWO_SIDED|90.0|1.14|1.44|||||Ratio of Geometric LS mean is for S-warfarin.|||1.44|1.14|
71762294|NCT01388335|143026622|SUPERIORITY_OR_OTHER_LEGACY||Ratio|1.26|||||TWO_SIDED|90.0|1.08|1.47|||||Ratio of Geometric LS mean is for R-warfarin.|||1.47|1.08|
71762295|NCT01388335|143026627|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.92|||||TWO_SIDED|90.0|0.86|1.0|||||Ratio of Geometric LS mean.|||1.00|0.86|
71762296|NCT01388335|143026628|SUPERIORITY_OR_OTHER_LEGACY||Ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Ratio of Geometric LS mean.|||1.02|0.95|
71762297|NCT01388335|143026631|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Mean|1.03||||||90.0|0.99|1.08|||||Ratio of Geometric LS mean for Period 2, Day 14, 0 hours.|||1.08|0.99|
71762298|NCT01388335|143026631|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric LS Means|1.02|||||TWO_SIDED|90.0|0.98|1.06|||||Ratio of Geometric LS mean for Period 2, Day 14, 4 hours.|||1.06|0.98|
71762299|NCT04413617|143026639|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.0158|TWO_SIDED|90.0|-0.62|-0.08|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||-0.08|-0.62|0.0158
71762300|NCT04413617|143026639|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.3933|TWO_SIDED|90.0|-0.32|0.23|||Mixed Model Repeated Measures|||The primary clinical hypothesis is that mean decrease at Week 12 in DAS28-CRP score in one or both combo arms exceeds the mean decrease in the reference (tofacitinib) treatment arm, regardless of occurrence of intercurrent events. The null hypothesis is that the mean decrease in DAS28-CRP score at Week 12 is identical in the control (tofacitinib arm) and combination arms.||0.23|-0.32|0.3933
71886158|NCT00662792|143292980|SUPERIORITY||Difference of adjusted means|-0.095|STANDARD_ERROR_OF_MEAN|0.031||0.0026|TWO_SIDED|95.0|-0.157|-0.033|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-0.033|-0.157|0.0026
71762301|NCT02657408|143026649|EQUIVALENCE|confirmatory statistical hypothesis tested|Geometric mean ratio (%)|1.27||||0.3043|TWO_SIDED|90.0|0.86|1.87|||ANOVA|||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.87|0.86|0.3043
71762302|NCT02657408|143026650|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.01|||||TWO_SIDED|90.0|0.88|1.16||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.16|0.88|
71762303|NCT02657408|143026651|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.54|||||TWO_SIDED|90.0|0.59|4.03||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||4.03|0.59|
71762304|NCT02657408|143026652|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.17|||||TWO_SIDED|90.0|0.49|2.85||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||2.85|0.49|
71762305|NCT02657408|143026653|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.29|||||TWO_SIDED|90.0|0.91|1.83||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.83|0.91|
71762306|NCT02657408|143026654|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.03|||||TWO_SIDED|90.0|0.9|1.18||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.18|0.90|
71762307|NCT02657408|143026655|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|1.18|||||TWO_SIDED|90.0|0.91|1.53||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.53|0.91|
71762308|NCT02657408|143026656|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.94|||||TWO_SIDED|90.0|0.8|1.09||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.09|0.80|
71762309|NCT02657408|143026657|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.81|||||TWO_SIDED|90.0|0.51|1.28||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||1.28|0.51|
71642696|NCT03043872|142803877|OTHER||Hazard Ratio (HR)|0.65||||0.0664|TWO_SIDED|95.0|0.414|1.029||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.029|0.414|0.0664
71642697|NCT03043872|142803878|OTHER||Hazard Ratio (HR)|0.75||||0.1455|TWO_SIDED|95.0|0.504|1.106||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.106|0.504|0.1455
71642698|NCT03043872|142803878|OTHER||Hazard Ratio (HR)|0.65||||0.0314|TWO_SIDED|95.0|0.439|0.964||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||0.964|0.439|0.0314
71642699|NCT03043872|142803879|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4352|TWO_SIDED|95.0|0.89|1.309||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP.||1.309|0.890|0.4352
71642700|NCT03043872|142803880|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0157|TWO_SIDED|95.0|0.665|0.959||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP.||0.959|0.665|0.0157
71642701|NCT03043872|142803880|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0568|TWO_SIDED|95.0|0.696|1.005||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP.||1.005|0.696|0.0568
71642702|NCT03043872|142803880|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.235||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP.||1.235|0.857|0.7540
71642703|NCT03043872|142803881|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0177|TWO_SIDED|95.0|1.086|2.401||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP.||2.401|1.086|0.0177
71642704|NCT03043872|142803881|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3611|TWO_SIDED|95.0|0.817|1.746||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP.||1.746|0.817|0.3611
71642705|NCT03043872|142803893|OTHER||Hazard Ratio (HR)|0.86||||0.447|TWO_SIDED|95.0|0.574|1.277||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer OS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.277|0.574|0.4470
71642706|NCT03043872|142803894|OTHER||Hazard Ratio (HR)|0.97||||0.8934|TWO_SIDED|95.0|0.661|1.437||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + EP vs EP. HR \<1 favors D + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.437|0.661|0.8934
71660928|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.05||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.050
71762310|NCT02657408|143026658|EQUIVALENCE|No statistical hypothesis tested|Geometric mean ratio (%)|0.64|||||TWO_SIDED|90.0|0.43|0.97||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.||0.97|0.43|
71762311|NCT02504216|143026735|SUPERIORITY||Hazard Ratio (HR)|0.85|||=|0.0043|TWO_SIDED|95.0|0.76|0.96|||Log Rank|P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||IxRS: Interactive web/voice response system||0.96|0.76|=0.0043
71762312|NCT02504216|143026736|OTHER||Hazard Ratio (HR)|1.43|||=|0.0695|TWO_SIDED|95.0|0.97|2.1|||Log Rank|P-value (2-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.||||2.10|0.97|=0.0695
71762313|NCT02504216|143026737|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0004|TWO_SIDED|95.0|0.71|0.91||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.91|0.71|=0.0004
71762314|NCT02504216|143026738|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.014|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0140
71823533|NCT00689104|143150461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44||||0.005|TWO_SIDED|95.0|-0.74|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.74|0.005
71823534|NCT00689104|143150461|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25||||0.11|TWO_SIDED|95.0|-0.55|0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||0.06|-0.55|0.11
71823535|NCT00689104|143150462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.9|||<|0.001|TWO_SIDED|95.0|6.3|17.4||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.4|6.3|<0.001
71823536|NCT00689104|143150462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|13.2|||<|0.001|TWO_SIDED|95.0|7.7|18.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.7|7.7|<0.001
71823537|NCT00689104|143150462|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.6|||<|0.001|TWO_SIDED|95.0|7.1|18.2||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||18.2|7.1|<0.001
71642707|NCT03043872|142803894|OTHER||Hazard Ratio (HR)|0.72||||0.1035|TWO_SIDED|95.0|0.487|1.068||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer PFS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.068|0.487|0.1035
71762315|NCT02504216|143026739|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.62|0.85||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.85|0.62|<0.0001
71762316|NCT02504216|143026740|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.0145|TWO_SIDED|95.0|0.79|0.99||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.99|0.79|=0.0145
71762317|NCT02504216|143026741|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0051|TWO_SIDED|95.0|0.76|0.96||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||0.96|0.76|=0.0051
71762318|NCT02504216|143026742|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.8322|TWO_SIDED|95.0|0.92|1.27||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.27|0.92|=0.8322
71762319|NCT02504216|143026743|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0235|TWO_SIDED|95.0|0.37|1.0||P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.|Log Rank|||||1.00|0.37|=0.0235
71762320|NCT02504216|143026744|OTHER||Hazard Ratio (HR)|1.42|||=|0.0068|TWO_SIDED|95.0|1.1|1.84|||Log Rank|||||1.84|1.10|=0.0068
71762321|NCT02504216|143026745|OTHER||Hazard Ratio (HR)|1.29|||=|0.0979|TWO_SIDED|95.0|0.95|1.76|||Log Rank|||||1.76|0.95|=0.0979
71762322|NCT03237286|143026781|SUPERIORITY|||||||0.0004|||||||Regression, Linear|||||||.0004
71762323|NCT00948441|143026801|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||t-test, 2 sided|||matched pairs T test to compare infection rates during the two study periods||||0.012
71642708|NCT03043872|142803894|OTHER||Hazard Ratio (HR)|0.76||||0.1673|TWO_SIDED|95.0|0.522|1.116||Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.|Log Rank||The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.|D + T + EP vs D + EP. HR \<1 favors D + T + EP to be associated with a longer PFS than D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||1.116|0.522|0.1673
71762324|NCT02093819|143026804|SUPERIORITY_OR_OTHER||Slope|1.1313|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|1.0249|1.2376|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.2376|1.0249|
71762325|NCT02093819|143026804|SUPERIORITY_OR_OTHER||Slope|0.9568|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|90.0|0.783|1.1307|||||Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1307|0.7830|
71762326|NCT02093819|143026805|SUPERIORITY_OR_OTHER||Slope|1.0732|STANDARD_ERROR_OF_MEAN|0.0468|||TWO_SIDED|90.0|0.9946|1.1518|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1518|0.9946|
71762327|NCT02093819|143026805|SUPERIORITY_OR_OTHER||Slope|0.9603|STANDARD_ERROR_OF_MEAN|0.0838|||TWO_SIDED|90.0|0.8174|1.1032|||||Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.||1.1032|0.8174|
71642709|NCT03043872|142803895|OTHER||Odds Ratio (OR)|1.39||||0.432|TWO_SIDED|95.0|0.61|3.244||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + EP vs EP. An odds ratio \>1 favors D + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||3.244|0.610|0.4320
71823538|NCT00689104|143150463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.71|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.71|0.002
71642710|NCT03043872|142803895|OTHER||Odds Ratio (OR)|2.07||||0.0986|TWO_SIDED|95.0|0.874|5.118||Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.|Regression, Logistic|||D + T + EP vs EP. An odds ratio \>1 favors D + T + EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.||5.118|0.874|0.0986
71642711|NCT03649477|142803907|SUPERIORITY||Mean Difference (Net)|-1.202||||0.3493|TWO_SIDED|95.0|-3.729|1.324||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.324|-3.729|0.3493
71642712|NCT03649477|142803907|SUPERIORITY||Mean Difference (Net)|-3.136||||0.0162|TWO_SIDED|95.0|-5.685|-0.586||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.586|-5.685|0.0162
71642713|NCT03649477|142803908|SUPERIORITY||Mean Difference (Net)|-0.608||||0.6001|TWO_SIDED|95.0|-2.89|1.674||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.674|-2.890|0.6001
71642714|NCT03649477|142803908|SUPERIORITY||Mean Difference (Net)|-0.764||||0.5143|TWO_SIDED|95.0|-3.068|1.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||1.541|-3.068|0.5143
71642715|NCT03649477|142803909|SUPERIORITY||Mean Difference (Net)|0.183||||0.9144|TWO_SIDED|95.0|-3.175|3.541||0.05 threshold for statistical significance|Mixed Models Analysis|||||3.541|-3.175|0.9144
71762328|NCT01708902|143026848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0587|TWO_SIDED|95.0|-0.45|0.01|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||0.01|-0.45|0.0587
71762329|NCT01708902|143026848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.23|-0.78|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.78|-1.23|<0.0001
71762330|NCT01708902|143026848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.73|-0.29|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.29|-0.73|<0.0001
71762331|NCT01708902|143026848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.09|-0.64|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."||-0.64|-1.09|<0.0001
71762332|NCT01708902|143026849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|STANDARD_ERROR_OF_MEAN|0.487||0.0771|TWO_SIDED|95.0|0.946|2.961|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.961|0.946|0.0771
71762333|NCT01708902|143026849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.489|STANDARD_ERROR_OF_MEAN|1.543|<|0.0001|TWO_SIDED|95.0|3.164|9.522|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||9.522|3.164|<0.0001
71762334|NCT01708902|143026849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.829|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|1.678|4.767|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.767|1.678|<0.0001
71762335|NCT01708902|143026849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|2.259|6.454|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.454|2.259|<0.0001
71762336|NCT01708902|143026850|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.169|STANDARD_ERROR_OF_MEAN|1.565||0.0001|TWO_SIDED|95.0|1.997|8.701|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||8.701|1.997|0.0001
71762337|NCT01708902|143026851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661|STANDARD_ERROR_OF_MEAN|0.426||0.048|TWO_SIDED|95.0|1.004|2.746|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.746|1.004|0.0480
71762338|NCT01708902|143026851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.923|STANDARD_ERROR_OF_MEAN|1.632|<|0.0001|TWO_SIDED|95.0|3.452|10.164|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.164|3.452|<0.0001
71762339|NCT01708902|143026851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.574|STANDARD_ERROR_OF_MEAN|0.655||0.0002|TWO_SIDED|95.0|1.563|4.239|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||4.239|1.563|0.0002
71762340|NCT01708902|143026851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.682|STANDARD_ERROR_OF_MEAN|1.27|<|0.0001|TWO_SIDED|95.0|2.751|7.968|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.968|2.751|<0.0001
71762341|NCT01708902|143026852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135|STANDARD_ERROR_OF_MEAN|1.31||0.0062|TWO_SIDED|95.0|1.383|7.11|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||7.110|1.383|0.0062
71762342|NCT01708902|143026853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0109|TWO_SIDED|95.0|-0.53|-0.07|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.07|-0.53|0.0109
71762343|NCT01708902|143026853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.27|-0.81|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.81|-1.27|<0.0001
71762344|NCT01708902|143026853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.24|-0.70|<0.0001
71762345|NCT01708902|143026853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.58|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."||-0.58|-1.04|<0.0001
71642716|NCT03649477|142803909|SUPERIORITY||Mean Difference (Net)|-3.812||||0.0266|TWO_SIDED|95.0|-7.177|-0.446||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.446|-7.177|0.0266
71642717|NCT03649477|142803910|SUPERIORITY||Mean Difference (Net)|-0.312||||0.1598|TWO_SIDED|95.0|-0.748|0.125||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.125|-0.748|0.1598
71642718|NCT03649477|142803910|SUPERIORITY||Mean Difference (Net)|-0.498||||0.0266|TWO_SIDED|95.0|-0.937|-0.059||0.05 threshold for statistical significance|Mixed Models Analysis|||||-0.059|-0.937|0.0266
71642719|NCT03649477|142803911|SUPERIORITY||Mean Difference (Net)|-1.085||||0.2479|TWO_SIDED|95.0|-2.932|0.761||0.05 threshold for statistical significance|Mixed Models Analysis|||||0.761|-2.932|0.2479
71642720|NCT03649477|142803911|SUPERIORITY||Mean Difference (Net)|-2.412||||0.0114|TWO_SIDED|95.0|-4.276|-0.548||0.05 for statistical significance|Mixed Models Analysis|||||-0.548|-4.276|0.0114
71642721|NCT01097577|142803926|SUPERIORITY|||||||0.18|||||||ANOVA|||This study was designed to determine if pregabalin is an effective regimen for postoperative pain control following PRK. We hypothesized that there will be at least a 10% improvement in pain after PRK using a scheduled pregabalin dosing regimen compared to placebo. A power analysis was completed to determine the number of patients necessary.||||0.180
71642722|NCT01097577|142803927|SUPERIORITY|||||||0.207|||||||ANOVA|||||||0.207
71642723|NCT01097577|142803928|SUPERIORITY|||||||0.283|||||||ANOVA|||||||0.283
71642724|NCT01097577|142803929|SUPERIORITY|Question 1: Pain at its worst||||||0.223|||||||ANOVA|||||||0.223
71642725|NCT01097577|142803930|SUPERIORITY|||||||0.311|||||||ANOVA|||||||0.311
71642726|NCT01097577|142803931|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||Days to Heal, OD||||0.581
71642727|NCT01097577|142803931|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||Days to Heal, OS||||0.307
71642728|NCT00748072|142803932|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Chi-squared|||The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level \<0.05 was calculated in 158 patients.||0.85|0.24|0.01
71642729|NCT04493684|142804002|OTHER||Geometric Least Square Mean Ratio|2.462|||||TWO_SIDED|90.0|1.823|3.323|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-24). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.323|1.823|
71642730|NCT04493684|142804002|OTHER||Geometric Least Square Mean Ratio|1.381|||||TWO_SIDED|90.0|1.223|1.56|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-24). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.56|1.223|
71642731|NCT04493684|142804003|OTHER||Geometric Least Square Mean Ratio|2.103|||||TWO_SIDED|90.0|1.629|2.717|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter AUC (0-inf). Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||2.717|1.629|
71642732|NCT04493684|142804003|OTHER||Geometric Least Square Mean Ratio|1.351|||||TWO_SIDED|90.0|1.22|1.497|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter AUC (0-inf). Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.497|1.22|
71642733|NCT04493684|142804004|OTHER||Geometric Least Square Mean Ratio|2.307|||||TWO_SIDED|90.0|1.668|3.19|||Mixed Models Analysis|||The mixed model was used to estimate Food Effect for the log transformed parameter Cmax. Analysis was performed using fed/ fasted state and tablet/ PiB as fixed effects and participant as a random effect.||3.19|1.668|
71642734|NCT04493684|142804004|OTHER||Geometric Least Square Mean Ratio|1.372|||||TWO_SIDED|90.0|1.19|1.582|||Mixed Models Analysis|||The mixed model was used to estimate Tablet vs. PiB effect for the log transformed parameter Cmax. Analysis was performed using the independent variables included a fixed effect for treatment (PiB or Tablet) and period, and participant as a random effect.||1.582|1.19|
71642735|NCT05152576|142804071|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
71642736|NCT05152576|142804071|SUPERIORITY||Rate Difference|38.2|||<|0.001|TWO_SIDED|95.0|19.2|57.1||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||57.1|19.2|<0.001
71642737|NCT05152576|142804071|SUPERIORITY||Rate Difference|41.4|||<|0.001|TWO_SIDED|95.0|23.5|59.3||Based on CMH test stratified by baseline investigator-rated FWS-FHL at maximum.|Cochran-Mantel-Haenszel|||Confidence interval for responder rate is calculated using normal approximation.||59.3|23.5|<0.001
71642738|NCT04516434|142804089|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71642739|NCT04516434|142804089|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
71642740|NCT04516434|142804090|OTHER|Descriptive analysis||||||0.08|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.08
71642741|NCT04516434|142804090|OTHER|Descriptive analysis||||||0.045|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.045
71642742|NCT04516434|142804092|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
71642743|NCT04516434|142804092|OTHER|Descriptive analysis||||||0.41|||||||Mixed Models Analysis|||First sensation of bladder filling - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.41
71642744|NCT04516434|142804092|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||1
71642745|NCT04516434|142804092|OTHER|Descriptive analysis||||||0.01|||||||Mixed Models Analysis|||Maximum cystometric capacity - change in cystometry before stimulation and after stimulation (up to 60 minutes).||||0.01
71642746|NCT04516434|142804093|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71762346|NCT01708902|143026854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.32||0.0001|TWO_SIDED|95.0|-1.87|-0.63|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|"The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.~The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate."||-0.63|-1.87|0.0001
71762347|NCT01708902|143026855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986|STANDARD_ERROR_OF_MEAN|0.387||0.9705|TWO_SIDED|95.0|0.456|2.13|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||2.130|0.456|0.9705
71762348|NCT01708902|143026855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.093|STANDARD_ERROR_OF_MEAN|1.029||0.0007|TWO_SIDED|95.0|1.612|5.938|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.938|1.612|0.0007
71762349|NCT01708902|143026855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|STANDARD_ERROR_OF_MEAN|1.243||0.0029|TWO_SIDED|95.0|1.486|6.849|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."||6.849|1.486|0.0029
71762350|NCT01708902|143026855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.871|STANDARD_ERROR_OF_MEAN|1.846|<|0.0001|TWO_SIDED|95.0|2.318|10.238|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||10.238|2.318|<0.0001
71762351|NCT01708902|143026856|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.865|STANDARD_ERROR_OF_MEAN|1.015||0.2523|TWO_SIDED|95.0|0.642|5.42|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||5.420|0.642|0.2523
71762352|NCT01708902|143026857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.37|STANDARD_ERROR_OF_MEAN|3.23||0.0971|TWO_SIDED|95.0|-11.72|0.98|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||0.98|-11.72|0.0971
71762353|NCT01708902|143026857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.42|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-38.67|-26.16|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-26.16|-38.67|<0.0001
71762354|NCT01708902|143026857|SUPERIORITY_OR_OTHER||Median Difference (Net)|-9.47|STANDARD_ERROR_OF_MEAN|3.16||0.0028|TWO_SIDED|95.0|-15.66|-3.27|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-3.27|-15.66|0.0028
71762355|NCT01708902|143026857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.31|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-30.54|-18.08|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-18.08|-30.54|<0.0001
71762356|NCT01708902|143026858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.21|STANDARD_ERROR_OF_MEAN|9.23||0.0002|TWO_SIDED|95.0|-53.48|-16.95|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.||-16.95|-53.48|0.0002
71762357|NCT01708902|143026859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209|STANDARD_ERROR_OF_MEAN|0.148||0.0271|TWO_SIDED|95.0|0.052|0.838|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.838|0.052|0.0271
71762358|NCT01708902|143026859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.965|STANDARD_ERROR_OF_MEAN|0.916||0.9699|TWO_SIDED|95.0|0.15|6.202|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||6.202|0.150|0.9699
71762359|NCT01708902|143026859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.183|STANDARD_ERROR_OF_MEAN|0.147||0.0343|TWO_SIDED|95.0|0.038|0.882|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi-complete separation of data points, the results shown are based on the last maximum likelihood iteration."||0.882|0.038|0.0343
71762360|NCT01708902|143026860|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.114|STANDARD_ERROR_OF_MEAN|0.125||0.0474|TWO_SIDED|95.0|0.013|0.976|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."||0.976|0.013|0.0474
71642747|NCT04516434|142804093|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71762361|NCT02445794|143026892|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||.008
71762362|NCT02758184|143026893|OTHER||Mean Difference (Final Values)|1031.2|STANDARD_ERROR_OF_MEAN|681.7||0.15|TWO_SIDED||||||ANOVA|||||||0.15
71762363|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.06||||0.69||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.69
71642748|NCT04516434|142804094|OTHER|Descriptive analysis||||||1|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||1
71642749|NCT04516434|142804094|OTHER|Descriptive analysis||||||0.99|||||||Mixed Models Analysis|||Change from baseline to after the pressure-flow study||||0.99
71642750|NCT04278560|142804095|SUPERIORITY||Mean Difference (Net)|385.3||||0.009|TWO_SIDED|||||Repeated Measures Two-Way ANOVA: Group, Time, Group x Time, and controlled by Baseline Step Counts|ANOVA|||||||0.009
71702239|NCT02293499|142921282|SUPERIORITY||partial eta squared|0.0||||0.484|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.484
71702240|NCT02293499|142921282|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71702241|NCT02293499|142921283|SUPERIORITY||partial eta squared|0.0||||0.648|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.648
71702242|NCT02293499|142921283|SUPERIORITY||partial eta squared|0.07||||0.04|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.04
71702243|NCT02293499|142921284|SUPERIORITY||partial eta squared|0.003||||0.02|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.020
71702244|NCT02293499|142921284|SUPERIORITY||partial eta squared|0.04||||0.23|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.23
71702245|NCT02293499|142921285|SUPERIORITY||partial eta squared|0.002||||0.049|TWO_SIDED|||||A priori threshold for statistical significance is \<.05.|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the change between treatment groups (Adult led vs. peer led asthma self-management). Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.049
71702246|NCT02293499|142921285|SUPERIORITY||partial eta squared|0.12||||0|TWO_SIDED|||||A priori threshold for statistical significance is \<.05|Mixed Models Analysis|||For each model, partial eta squared (η2) was reported as the effect size for the overall change over time. Partialη2 is the proportion of variance explained by a given variable out of the variance remaining after excluding variance explained by other predictors. Partial η2\> 0.14 indicates large effects, while η2= 0.06 to 0.14 medium and \< 0.06 small effects||||.00
71702247|NCT02293499|142921285|SUPERIORITY||Slope|-0.294||||0.004|TWO_SIDED||||||Mixed Models Analysis|||||||.004
71702248|NCT02293499|142921285|SUPERIORITY||Sobel Statistic|-2.3505||||0.0093|TWO_SIDED||||||Sobel|||Mediator analysis of AMI-SEI subscale on ACQ total||||.0093
71702249|NCT05370326|142921299|SUPERIORITY||Mean Difference (Net)|0.89||||0.69|TWO_SIDED|95.0|-3.67|5.46|||t-test, 2 sided|||||5.46|-3.67|0.69
71702250|NCT05370326|142921304|SUPERIORITY||Mean Difference (Net)|0.23||||0.67|TWO_SIDED|95.0|-0.89|1.36|||t-test, 2 sided|||||1.36|-0.89|0.67
71702251|NCT05370326|142921305|SUPERIORITY||Mean Difference (Net)|0.59||||0.5|TWO_SIDED|95.0|-1.16|2.34|||t-test, 2 sided|||||2.34|-1.16|0.50
71702252|NCT05370326|142921306|SUPERIORITY||Mean Difference (Net)|0.2||||0.74|TWO_SIDED|95.0|-1.09|1.51|||t-test, 2 sided|||||1.51|-1.09|0.74
71702253|NCT05370326|142921308|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71702254|NCT05370326|142921309|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71702255|NCT00817063|142921361|SUPERIORITY||Odds Ratio (OR)|3.78|||<|0.001|TWO_SIDED|95.0|2.55|5.62|||Chi-squared, Corrected|||||5.62|2.55|<0.001
71702256|NCT00817063|142921361|SUPERIORITY||Difference in Percentage|24.8|||<|0.001|TWO_SIDED|95.0|18.0|31.7|||Chi-squared, Corrected|||||31.7|18.0|<0.001
71702257|NCT00817063|142921362|SUPERIORITY||Mean Difference (Net)|-24.13|||<|0.001|TWO_SIDED|95.0|-30.4|-17.85|||Kruskal-Wallis|||||-17.85|-30.40|<0.001
71702258|NCT00817063|142921363|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001|TWO_SIDED|95.0|2.71|6.07|||Chi-squared, Corrected|||||6.07|2.71|<0.001
71702259|NCT00817063|142921363|SUPERIORITY||Difference in Percentage|25.5|||<|0.001|TWO_SIDED|95.0|18.7|32.3|||Chi-squared, Corrected|||||32.3|18.7|<0.001
71702260|NCT00817063|142921364|SUPERIORITY||Mean Difference (Net)|-22.36|||<|0.001|TWO_SIDED|95.0|-31.0|-13.73|||Kruskal-Wallis|||||-13.73|-31.00|<0.001
71702261|NCT00817063|142921365|SUPERIORITY|||||||0.047|||||||Log Rank|||||||0.047
71702262|NCT00817063|142921366|SUPERIORITY|||||||0.068|||||||Log Rank|||||||0.068
71702263|NCT00817063|142921367|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71702264|NCT00817063|142921376|SUPERIORITY||Mean Difference (Net)|0.489||||0.179|TWO_SIDED|95.0|-0.226|1.204||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Lumbar Spine BMD||1.204|-0.226|0.179
71762364|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.3||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.30
71642751|NCT04278560|142804096|SUPERIORITY||Mean Difference (Net)|1.2||||0.03|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.03
71702265|NCT00817063|142921376|SUPERIORITY||Mean Difference (Net)|0.497||||0.089|TWO_SIDED|95.0|-0.077|1.071||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (\<12weeks, \>=12 weeks) as covariates.|ANCOVA|||Femur BMD||1.071|-0.077|0.089
71702266|NCT02111980|142921388|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
71762365|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||<0.0001
71642752|NCT04278560|142804097|SUPERIORITY||Mean Difference (Net)|0.19||||0.4|TWO_SIDED||||||ANOVA|We used change from baseline for the analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.4
71642753|NCT04278560|142804098|SUPERIORITY||Mean Difference (Net)|3.1||||0.016|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.016
71642754|NCT04278560|142804099|SUPERIORITY||Mean Difference (Net)|9.94||||0.17|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.17
71642755|NCT04278560|142804100|SUPERIORITY||Median Difference (Net)|0.6||||0.1|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline.||||||0.1
71642756|NCT04278560|142804101|SUPERIORITY||Median Difference (Net)|0.07||||0.7|TWO_SIDED||||||ANOVA|We used change from baseline for this analysis. Two-Way Repeated Measure ANOVA: Group, Time, Group x Time, and controlled baseline||||||0.7
71642757|NCT04278560|142804102|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71642758|NCT04278560|142804103|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
71642759|NCT02832063|142804106|EQUIVALENCE|Primary efficacy power calculations assume a \>25% difference between B244 treatment and placebo and a 15% dropout. Each of the endpoints comprising the co-primary endpoint will be tested at an alpha level of p\<0.05. In order to achieve 90% power with a 5% Type I error rate, a total of 372 participants is required.||||||0.034|||||||ANCOVA|||||||0.034
71642760|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.05|0.171|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~The primary endpoint was analyzed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects and baseline as a covariate. The confidence intervals (CIs) and the p-values of the comparisons between each dose of CHF 1531 pMDI and Placebo at Day 14 were adjusted for multiplicity, based on the parametric simulation method of Edwards and Berry."||0.171|0.050|<0.001
71642761|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.095|0.22|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.220|0.095|<0.001
71642762|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.072|0.194|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.194|0.072|<0.001
71642763|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.167|||<|0.001|TWO_SIDED|95.0|0.109|0.225|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.225|0.109|<0.001
71642764|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.144|||<|0.001|TWO_SIDED|95.0|0.098|0.19|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.190|0.098|<0.001
71642765|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.059|TWO_SIDED|95.0|-0.002|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~The statistical analysis was performed using an analysis of covariance (ANCOVA) including treatment, period, and patient as fixed effects, and baseline as a covariate."||0.095|-0.002|0.059
71642766|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.361|TWO_SIDED|95.0|-0.026|0.07|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.070|-0.026|0.361
71642767|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.016|TWO_SIDED|95.0|0.011|0.102|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.102|0.011|0.016
71642768|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|-0.025||||0.34|TWO_SIDED|95.0|-0.075|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.075|0.340
71642769|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.69|TWO_SIDED|95.0|-0.038|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.038|0.690
71642770|NCT03086460|142804127|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.155|TWO_SIDED|95.0|-0.013|0.082|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.082|-0.013|0.155
71762366|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.67||||0.001||95.0||||Values from Groups I, II and III were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.001
71762367|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.08||||0.61||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||0.61
71762368|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.02||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||0.02
71762369|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.45||||0.002||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||0.002
71762370|NCT00488683|143027030|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||0.08
71762371|NCT00488683|143027030|SUPERIORITY_OR_OTHER||R-square|0.004||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A||||
71762372|NCT00488683|143027030|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C||||
71762373|NCT00488683|143027030|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135||||
71762374|NCT00488683|143027030|SUPERIORITY_OR_OTHER||R-square|0.45||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y||||
71762375|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.70
71762376|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.37||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.37
71762377|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.66|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||<0.0001
71762378|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.9|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||<0.0001
71762379|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.01||||0.94||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||0.94
71762380|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||0.70
71762381|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.3||||0.04||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||0.04
71762382|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46||||0.004||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||0.004
71762383|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.005||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A||||
71762384|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C||||
71762385|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.43||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135||||
71762386|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.82||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y||||
71762387|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.68||95.0||||Values from Group 1, 2 and 2 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.68
71642771|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.049|0.175|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.175|0.049|<0.001
71642772|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.101|0.23|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.230|0.101|<0.001
71702267|NCT01922011|142921405|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% CI is greater than -15%|Common Difference|-6.1||||0.421|TWO_SIDED|95.0|-19.4|7.4|||Wald||Daptomycin - Comparator|95% confidence interval of the common difference was based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.||7.4|-19.4|0.421
71702268|NCT01922011|142921406|SUPERIORITY_OR_OTHER||Common difference|-7.1||||0.467|TWO_SIDED|95.0|-21.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|||7.9|-21.6|0.467
71702269|NCT01922011|142921407|SUPERIORITY_OR_OTHER||Common difference|-6.2||||0.313|TWO_SIDED|95.0|-17.5|5.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOIV visit||5.0|-17.5|0.313
71702270|NCT01922011|142921407|SUPERIORITY_OR_OTHER||Common difference|-7.9||||0.239|TWO_SIDED|95.0|-19.8|4.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOT visit||4.0|-19.8|0.239
71702271|NCT01922011|142921407|SUPERIORITY_OR_OTHER||Common difference|-6.7||||0.37|TWO_SIDED|95.0|-19.1|5.8|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At TOC visit||5.8|-19.1|0.370
71702272|NCT01922011|142921408|SUPERIORITY_OR_OTHER||Common difference|-10.5||||0.23|TWO_SIDED|95.0|-26.3|5.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||5.4|-26.3|0.230
71702273|NCT01922011|142921408|SUPERIORITY_OR_OTHER||Common difference|-12.3||||0.164|TWO_SIDED|95.0|-28.5|4.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||4.4|-28.5|0.164
71762388|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.46||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.46
71702274|NCT01922011|142921408|SUPERIORITY_OR_OTHER||Common difference|-15.5||||0.043|TWO_SIDED|95.0|-31.2|1.1|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||1.1|-31.2|0.043
71702275|NCT01922011|142921408|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wald|||MRSA||||0.450
71702276|NCT01922011|142921408|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wald|||Other Pathogen||||0.280
71702277|NCT01922011|142921409|SUPERIORITY_OR_OTHER||Common difference|-6.3||||0.272|TWO_SIDED|95.0|-18.2|5.5|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|EOT||5.5|-18.2|0.272
71702278|NCT01922011|142921409|SUPERIORITY_OR_OTHER||Common difference|-4.8||||0.48|TWO_SIDED|95.0|-17.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|TOC||7.9|-17.6|0.480
71702279|NCT01922011|142921410|SUPERIORITY_OR_OTHER||Common difference|-10.1|||||TWO_SIDED|95.0|-24.8|4.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen||4.2|-24.8|
71702280|NCT01922011|142921410|SUPERIORITY_OR_OTHER||Common difference|-12.2|||||TWO_SIDED|95.0|-27.2|2.8|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA||2.8|-27.2|
71702281|NCT01922011|142921410|SUPERIORITY_OR_OTHER||Common difference|-10.4|||||TWO_SIDED|95.0|-25.4|5.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA||5.2|-25.4|
71702282|NCT02299167|142921424|OTHER|The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Mean (95% CI) of effective dose in 90% (|1.9|||||TWO_SIDED|95.0|1.7|2.1|||||The ED50% of spinal bupivacaine was estimated using a modified Dixon's up-and-down method|Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction||2.1|1.7|
71702283|NCT04615507|142921429|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.00 logMAR for Distance.|Mean estimate|-0.132|STANDARD_ERROR_OF_MEAN|0.0201|||TWO_SIDED|95.0|-0.18|-0.083|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.083|-0.180|
71762389|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.2||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.08
71762390|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45|||<|0.001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||<0.001
71762391|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.04||||0.75||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||0.75
71762392|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.27||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||0.27
71762393|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.07||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||0.07
71762394|NCT00488683|143027031|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.23||||0.06||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||0.06
71762395|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.0029||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
71642773|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.138|||<|0.001|TWO_SIDED|95.0|0.074|0.203|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.203|0.074|<0.001
71642774|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.113|0.235|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.235|0.113|<0.001
71642775|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.197|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.197|0.101|<0.001
71762396|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.0059||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
71762397|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
71886159|NCT00662792|143292981|SUPERIORITY||Difference of adjusted means|11.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|6.9|16.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||16.8|6.9|<.0001
71762398|NCT00488683|143027031|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71762399|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.26||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
71642776|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the primary efficacy model with only data from the first instance of each treatment."||0.104|0.004|0.035
71762400|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.59||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.59
71762401|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.006||||0.98||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.98
71642777|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.301|TWO_SIDED|95.0|-0.024|0.076|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.076|-0.024|0.301
71642778|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.011|TWO_SIDED|95.0|0.014|0.11|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.110|0.014|0.011
71762402|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.2||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.20
71762403|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.08
71762404|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.68
71762405|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.006||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.006
71762406|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.16||||0.48||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.48
71762407|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.26||||0.46||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.46
71762408|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||0.40
71762409|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.12||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.60
71762410|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.4||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||0.03
71762411|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||0.001
71762412|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.0||||1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||1.00
71762413|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.24
71762414|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||0.34
71762415|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
71762416|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A||||
71762417|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
71762418|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C||||
71762419|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
71762420|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135||||
71762421|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
71762422|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y||||
71762423|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.0002||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.0002
71642779|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.294|TWO_SIDED|95.0|-0.08|0.024|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.024|-0.080|0.294
71823539|NCT00689104|143150463|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38||||0.002|TWO_SIDED|95.0|-0.71|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.71|0.002
71823540|NCT00689104|143150463|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.35||||0.019|TWO_SIDED|95.0|-0.68|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.03|-0.68|0.019
71823541|NCT00689104|143150464|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.004|TWO_SIDED|95.0|-0.66|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.66|0.004
71823542|NCT00689104|143150464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.79|-0.26||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.26|-0.79|<0.001
71823543|NCT00689104|143150464|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.016|TWO_SIDED|95.0|-0.6|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.||-0.06|-0.60|0.016
71823544|NCT01394991|143150493|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.248|TWO_SIDED|95.0|-0.051|0.016|||Chi-squared|||The primary hypothesis was that the group of participants receiving epoetin alfa QW and the group of participants receiving epoetin alfa TIW would have similar incidence rate of participants with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.||0.016|-0.051|0.248
71823545|NCT01394991|143150493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.254||95.0|0.18|1.58|||Regression, Logistic|||||1.58|0.18|0.254
71823546|NCT01394991|143150494|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.029||||0.08|TWO_SIDED|95.0|-0.065|0.007|||Chi-squared|||||0.007|-0.065|0.08
71823547|NCT01394991|143150495|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.073|TWO_SIDED|95.0|0.14|1.13|||Log Rank|The stratified log-rank test accounting for ECOG performance status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model with covariates for treatment group and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2) was used for estimates of hazard ratio and its 95% confidence interval.|||1.13|0.14|0.073
71823548|NCT01394991|143150496|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.039||||0.059||95.0|-0.083|0.005|||Chi-squared|||||0.005|-0.083|0.059
71823549|NCT01394991|143150497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.054|TWO_SIDED|95.0|0.21|1.03|||Log Rank|The stratified log-rank test accounting for ECOG score status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model including covariates for treatment group and the Eastern Cooperative Oncology Group (ECOG) score status (0 or 1 versus 2) was used for estimates of a hazard ratio and its 95% confidence interval.|||1.03|0.21|0.054
71823550|NCT01394991|143150498|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0041||||0.88||95.0|-0.0526|0.0608|||Chi-squared|||||0.0608|-0.0526|0.88
71823551|NCT01394991|143150499|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.514|TWO_SIDED|95.0|-0.056|0.108|||Chi-squared|||||0.108|-0.056|0.514
71823552|NCT01394991|143150500|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.92|TWO_SIDED|95.0|-0.071|0.065|||Chi-squared|||||0.065|-0.071|0.920
71823553|NCT01324882|143150506|OTHER|||||||1|||||||Fisher Exact|||||||1.00
71823554|NCT01955382|143150509|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71823555|NCT01251614|143150554|SUPERIORITY_OR_OTHER||Difference|-25.5||||0.027|TWO_SIDED|95.0|-47.2|-3.7|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||-3.7|-47.2|0.027
71823556|NCT01251614|143150555|SUPERIORITY_OR_OTHER||Difference|-20.0||||0.083|TWO_SIDED|95.0|-42.2|2.2|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~1. Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~2. Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."||2.2|-42.2|0.083
71762424|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.03||||0.9||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.90
71762425|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.47||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.02
71762426|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.12||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.12
71762427|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.22||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.22
71762428|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.81|||<|0.0001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||<0.0001
71762429|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.15||||0.82||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.82
71762430|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.66||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.66
71762431|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.03||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.03
71762432|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.53||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||0.53
71762433|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.35||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.35
71762434|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.47||||0.09||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||0.09
71762435|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.51||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.04
71762436|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||0.10
71762437|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.35||||0.56||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.56
71762438|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.84||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||0.84
71762439|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.59||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
71762440|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.001||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A||||
71762441|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
71762442|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C||||
71762443|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
71762444|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.66||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135||||
71762445|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
71762446|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y||||
71762447|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.29||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.08
71762448|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.05||||0.74||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.74
71762449|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.01||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.94
71762450|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.09||||0.51||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
71642780|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.747|TWO_SIDED|95.0|-0.042|0.058|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.058|-0.042|0.747
71642781|NCT03086460|142804128|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.155|TWO_SIDED|95.0|-0.014|0.086|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.086|-0.014|0.155
71642782|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.136|||<|0.001|TWO_SIDED|95.0|0.065|0.207|||ANCOVA|||"Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment, which occurred after the randomization error."||0.207|0.065|<0.001
71642783|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.258|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.258|0.113|<0.001
71762451|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.27||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.12
71762452|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.25||||0.09||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.09
71762453|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.05||||0.81||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.81
71762454|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.28||||0.07||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.07
71762455|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.02
71762456|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.59||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.59
71642784|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.092|0.238|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.092|<0.001
71642785|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.185|||<|0.001|TWO_SIDED|95.0|0.118|0.252|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.118|<0.001
71642786|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.176|||<|0.001|TWO_SIDED|95.0|0.121|0.231|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.231|0.121|<0.001
71642787|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.088|TWO_SIDED|95.0|-0.008|0.108|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment, subject, and period as fixed effects; baseline FEV1 value as covariates. Subjects receiving the same treatment in more than one period are included in the model with only data for the instance of each treatment which occurred after the randomization error."||0.108|-0.008|0.088
71823557|NCT01251614|143150556|SUPERIORITY_OR_OTHER||Difference|-7.3||||0.466|TWO_SIDED|95.0|-26.9|12.3|||Chi-squared|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||12.3|-26.9|0.466
71702284|NCT04615507|142921429|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Intermediate.|Mean estimate|-0.066|STANDARD_ERROR_OF_MEAN|0.0202|||TWO_SIDED|95.0|-0.115|-0.017|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||-0.017|-0.115|
71702285|NCT04615507|142921429|SUPERIORITY|The superiority of the Test lens will be concluded if the upper confidence limit of the mean is below the predefined threshold +0.17 logMAR for Near.|Mean estimate|0.072|STANDARD_ERROR_OF_MEAN|0.0217|||TWO_SIDED|95.0|0.022|0.121|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom.||||0.121|0.022|
71702286|NCT04615507|142921430|SUPERIORITY|The superiority of the Test lens will be concluded if the lower confidence limit of the LSM is above the predefined threshold 32 points.|Least-square mean|59.6|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|95.0|52.3|66.8|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom||||66.8|52.3|
71702287|NCT04615507|142921430|NON_INFERIORITY|The non-Inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above -5 points.|Least-square mean difference|5.5|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.9|10.2|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom|LSM difference was calculated as Test minus Control|||10.2|0.9|
71702288|NCT01035788|142921495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|7.24||0.849|TWO_SIDED|95.0|-1.39|13.2|||Mixed Models Analysis|p value was obtained from the contrast of the linear mixed model||We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.||13.2|-1.39|.849
71702289|NCT01001104|142921497|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at 12 weeks.|Mixed Models Analysis|||||||<.001
71702290|NCT01001104|142921497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71702291|NCT01001104|142921497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.97|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71702292|NCT01001104|142921497|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.17|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71702293|NCT01001104|142921498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
71702294|NCT01001104|142921498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71702295|NCT01001104|142921498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71702296|NCT01001104|142921498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71702297|NCT01001104|142921499|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage|||||||<0.001
71702298|NCT01001104|142921499|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||Fisher Exact|||||||0.358
71702299|NCT01001104|142921499|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||||||0.014
71702300|NCT01001104|142921499|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71702301|NCT01001104|142921500|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
71702302|NCT01001104|142921500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.2||||0.003||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.003
71702303|NCT01001104|142921500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.54||||0.003||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.003
71702304|NCT01001104|142921500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.48|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71702305|NCT01001104|142921501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
71702306|NCT01001104|142921501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.2|||<|0.001||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71702307|NCT01001104|142921501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-45.63|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71702308|NCT01001104|142921501|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.49|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71702309|NCT01001104|142921502|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||0.987
71702310|NCT01001104|142921502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26||||0.005||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.005
71702311|NCT01001104|142921502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.45||||0.311||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.311
71702312|NCT01001104|142921502|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26||||0.556||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.556
71702313|NCT01001104|142921503|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||This is the p-value from the linear trend test at week 12.|Mixed Models Analysis|||||||0.202
71702314|NCT01001104|142921503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.91||||0.917||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.917
71762457|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.1||||0.51||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.51
71762458|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.9||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.9
71762459|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.02
71762460|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.19||||0.2||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.20
71762461|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.34||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.34
71762462|NCT00488683|143027032|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.33||||0.04||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.04
71762463|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71762464|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.0027||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71762465|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.0002||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71762466|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.0077||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71762467|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
71762468|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
71762469|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.0023||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
71762470|NCT00488683|143027032|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
71762471|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.25||||0.59||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.59
71762472|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.68
71762473|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.36||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.12
71762474|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.22||||0.26||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.26
71762475|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.08
71762476|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.17||||0.42||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.42
71762477|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.77||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.02
71762478|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.12||||0.65||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.65
71642788|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.323|TWO_SIDED|95.0|-0.029|0.088|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.088|-0.029|0.323
71642789|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.073|TWO_SIDED|95.0|-0.005|0.103|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.103|-0.005|0.073
71642790|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.489|TWO_SIDED|95.0|-0.08|0.039|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.039|-0.080|0.489
71642791|NCT03086460|142804129|SUPERIORITY||Median Difference (Final Values)|-0.001||||0.978|TWO_SIDED|95.0|-0.057|0.056|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.056|-0.057|0.978
71642792|NCT03086460|142804129|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.484|TWO_SIDED|95.0|-0.037|0.077|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.077|-0.037|0.484
71642793|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.048|0.166|||ANCOVA|||"Comparison groups:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. CIs and p-values for CHF 1531 pMDI vs Placebo are adjusted for multiplicity (parametric simulation method by Edwards and Berry). Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.166|0.048|<0.001
71642794|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.096|0.217|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.096|<0.001
71642795|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.073|0.193|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.193|0.073|<0.001
71642796|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.103|0.217|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.217|0.103|<0.001
71642797|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.102|0.192|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.192|0.102|<0.001
71642798|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.041|TWO_SIDED|95.0|0.002|0.098|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Analysis of covariance model: treatment and period as fixed effects, subject as random effect, baseline FEV1 value as covariate. Patients receiving the same treatment during two periods are considered twice in the ANCOVA model (once for each period attended)."||0.098|0.002|0.041
71642799|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.275|TWO_SIDED|95.0|-0.021|0.073|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.073|-0.021|0.275
71702315|NCT01001104|142921503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.81||||0.264||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.264
71702316|NCT01001104|142921503|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.4||||0.346||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.346
71762479|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.58||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||0.58
71642800|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.053||||0.021|TWO_SIDED|95.0|0.008|0.098|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.098|0.008|0.021
71702317|NCT01001104|142921504|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis|||||||<0.001
71642801|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.35|TWO_SIDED|95.0|-0.073|0.026|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.026|-0.073|0.350
71642802|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.886|TWO_SIDED|95.0|-0.044|0.051|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.051|-0.044|0.886
71642803|NCT03086460|142804130|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.254|TWO_SIDED|95.0|-0.02|0.074|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #6 of this outcome measure."||0.074|-0.020|0.254
71642804|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.114|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||ANCOVA|||"Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.169|0.060|<0.001
71823558|NCT01251614|143150557|SUPERIORITY_OR_OTHER||Difference|-15.7||||0.056|TWO_SIDED|95.0|-29.1|-2.3|||Fisher Exact|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.3|-29.1|0.056
71702318|NCT01001104|142921504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.1||||0.036||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis|||||||0.036
71702319|NCT01001104|142921504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|19.73||||0.002||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||0.002
71702320|NCT01001104|142921504|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|31.68|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis|||||||<0.001
71702321|NCT01001104|142921506|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||This is the p-value from the Cochran-Armitage trend test (dose-effect).|Cochran-Armitage|||||||0.073
71702322|NCT01001104|142921506|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71702323|NCT01001104|142921506|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||Fisher Exact|||||||0.233
71702324|NCT02397837|142921511|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
71702325|NCT02397837|142921512|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71702326|NCT02397837|142921513|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71702327|NCT02397837|142921514|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
71702328|NCT02397837|142921515|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
71702329|NCT02397837|142921516|OTHER|||||||0.98|||||||t-test, 2 sided|||||||0.98
71702330|NCT02397837|142921517|OTHER||||||||||||||||||Tabulation of participants with suicidal acknowledgements over 12-week study|||
71702331|NCT02397837|142921518|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71702332|NCT02397837|142921519|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
71702333|NCT02397837|142921520|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71702334|NCT01496456|142921543|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.||||||0.002
71702335|NCT01496456|142921544|SUPERIORITY_OR_OTHER|||||||0.045|||||||Regression, Logistic|Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.||||||0.045
71702336|NCT01496456|142921545|SUPERIORITY_OR_OTHER|||||||0.0077|||||||Discreet Time Survival Analysis|Controlled for correlation among tooth pairs (GEE model).||||||0.0077
71702337|NCT02583269|142921598|OTHER|||||||0.76|||||||ANOVA|||Overall FACT G score p value baseline to week 8||||0.76
71702338|NCT02583269|142921598|OTHER|||||||0.25|||||||ANOVA|||Fact G functional well being p value baseline to week 8||||0.25
71702339|NCT02583269|142921598|OTHER|||||||0.18|||||||ANOVA|||FACT G emotional well being p value baseline to week 8||||0.18
71702340|NCT02583269|142921598|OTHER|||||||0.87|||||||ANOVA|||Fact G physical well being p value baseline to week 8||||0.87
71702341|NCT02583269|142921598|OTHER|||||||0.22|||||||ANOVA|||Fact G social well being p value baseline to week 8||||0.22
71702342|NCT02583269|142921606|OTHER|||||||0.67|||||||ANOVA|||||||0.67
71702343|NCT02583269|142921607|OTHER|||||||0.119|||||||ANOVA|||Baseline v. 4 weeks log IL-8||||0.119
71702344|NCT02583269|142921607|OTHER|||||||0.414|||||||ANOVA|||Baseline v. 8 weeks log IL-8||||0.414
71702345|NCT02583269|142921608|OTHER|||||||0.851|||||||ANOVA|||Baseline v. 4 weeks p value log VEGF||||0.851
71702346|NCT02583269|142921608|OTHER|||||||0.688|||||||ANOVA|||Baseline vs. 8 weeks p value log VEGF||||0.688
71702347|NCT04167670|142921690|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|-0.3||||0.0037|TWO_SIDED|95.0|-7.39|6.76|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan dual therapy to lansoprazole triple therapy.||6.76|-7.39|0.0037
71702348|NCT04167670|142921690|NON_INFERIORITY|P-value based on a Farrington and Manning test with a noninferiority margin of 10%.|Percentage Difference|5.9|||<|0.0001|TWO_SIDED|95.0|-0.75|12.62|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Noninferiority of vonoprazan triple therapy to lansoprazole triple therapy.||12.62|-0.75|<0.0001
71762480|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.19||||-0.51||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||-0.51
71762481|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.24
71762482|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.36||||0.06||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||0.06
71762483|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.001
71762484|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.32||||0.12||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.12
71762485|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.49||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.18
71762486|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.25||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.34
71762487|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
71762488|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A||||
71762489|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
71762490|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C||||
71762491|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
71762492|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
71762493|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.6||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71762494|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71762495|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.83||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.001
71762496|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.14||||0.57||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.57
71762497|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.65||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.001
71762498|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.31||||0.11||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.11
71762499|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.02||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.94
71762500|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.0003||||1||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||1.00
71762501|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.004||||1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||1.00
71762502|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.3||||0.37||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.37
71762503|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.52||||0.09||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.09
71642805|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.154|||<|0.001|TWO_SIDED|95.0|0.099|0.208|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.099|<0.001
71642806|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.138|0.247|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.247|0.138|<0.001
71642807|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.216|||<|0.001|TWO_SIDED|95.0|0.163|0.268|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.268|0.163|<0.001
71642808|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.12|0.224|||ANCOVA|||"Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.224|0.120|<0.001
71642809|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.165|TWO_SIDED|95.0|-0.016|0.095|||ANCOVA|||"Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.016|0.165
71642810|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.005|TWO_SIDED|95.0|0.024|0.132|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.132|0.024|0.005
71642811|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.049|0.153|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.049|<0.001
71642812|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.187|TWO_SIDED|95.0|-0.019|0.097|||ANCOVA|||"Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.097|-0.019|0.187
71642813|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.028|TWO_SIDED|95.0|0.007|0.116|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.007|0.028
71642814|NCT03086460|142804131|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.406|TWO_SIDED|95.0|-0.031|0.076|||ANCOVA|||"Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.076|-0.031|0.406
71702349|NCT04167670|142921691|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|37.7|||<|0.0001|TWO_SIDED|95.0|20.54|52.56|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||52.56|20.54|<0.0001
71702350|NCT04167670|142921691|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|33.8|||<|0.0001|TWO_SIDED|95.0|17.74|48.12|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan triple therapy to lansoprazole triple therapy.||48.12|17.74|<0.0001
71642815|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.116|0.23|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.230|0.116|<0.001
71642816|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.203|||<|0.001|TWO_SIDED|95.0|0.146|0.26|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.260|0.146|<0.001
71642817|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.223|||<|0.001|TWO_SIDED|95.0|0.166|0.28|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.280|0.166|<0.001
71642818|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.27|||<|0.001|TWO_SIDED|95.0|0.216|0.325|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.325|0.216|<0.001
71702351|NCT04167670|142921692|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|8.7||||0.0063|TWO_SIDED|95.0|1.86|15.44|||Farrington and Manning test||The confidence interval of the difference in H pylori eradication rates between vonoprazan dual therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|Superiority of vonoprazan dual therapy to lansoprazole triple therapy.||15.44|1.86|0.0063
71702352|NCT04167670|142921692|SUPERIORITY|P-value based on a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|Percentage Difference|12.3||||0.0001|TWO_SIDED|95.0|5.72|18.81|||Farrington and Manning test|||Superiority of vonoprazan triple therapy to lansoprazole triple therapy.|The confidence interval of the difference in H pylori eradication rates between vonoprazan triple therapy and lansoprazole triple therapy was calculated via the Miettinen and Nurminen method.|18.81|5.72|0.0001
71642819|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.187|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.187|<0.001
71642820|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.308|TWO_SIDED|95.0|-0.028|0.089|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.089|-0.028|0.308
71642821|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.082|TWO_SIDED|95.0|-0.006|0.107|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.107|-0.006|0.082
71642822|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.097|||<|0.001|TWO_SIDED|95.0|0.043|0.152|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.152|0.043|<0.001
71642823|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.52|TWO_SIDED|95.0|-0.041|0.08|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.080|-0.041|0.520
71642824|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.067||||0.022|TWO_SIDED|95.0|0.01|0.124|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.124|0.010|0.022
71642825|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
71642826|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.095|0.21|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.210|0.095|<0.001
71642827|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.131|0.249|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.249|0.131|<0.001
71762504|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||0.40
71762505|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.2||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.20
71642828|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.113|0.228|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.228|0.113|<0.001
71642829|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.217|||<|0.001|TWO_SIDED|95.0|0.162|0.272|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.272|0.162|<0.001
71642830|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.144|0.252|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.252|0.144|<0.001
71642831|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.203|TWO_SIDED|95.0|-0.02|0.095|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.020|0.203
71642832|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.542|TWO_SIDED|95.0|-0.039|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.039|0.542
71642833|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.021|TWO_SIDED|95.0|0.01|0.119|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|0.010|0.021
71642834|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|95.0|-0.08|0.04|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.040|-0.080|0.510
71642835|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.352|TWO_SIDED|95.0|-0.03|0.084|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.084|-0.030|0.352
71642836|NCT03086460|142804132|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.098|TWO_SIDED|95.0|-0.009|0.103|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.103|-0.009|0.098
71642837|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.122|0.241|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.241|0.122|<0.001
71642838|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.192|||<|0.001|TWO_SIDED|95.0|0.133|0.251|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.251|0.133|<0.001
71642839|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.215|||<|0.001|TWO_SIDED|95.0|0.156|0.275|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.275|0.156|<0.001
71642840|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.252|||<|0.001|TWO_SIDED|95.0|0.195|0.309|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.309|0.195|<0.001
71642841|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.182|0.295|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.295|0.182|<0.001
71642842|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.723|TWO_SIDED|95.0|-0.049|0.071|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.071|-0.049|0.723
71642843|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.257|TWO_SIDED|95.0|-0.025|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.025|0.257
71642844|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.016|TWO_SIDED|95.0|0.014|0.128|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.128|0.014|0.016
71642845|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.464|TWO_SIDED|95.0|-0.039|0.086|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.039|0.464
71642846|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.048|TWO_SIDED|95.0|0.0|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|0.000|0.048
71762506|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||0.03
71762507|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.48||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.07
71642847|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.219|TWO_SIDED|95.0|-0.022|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.022|0.219
71642848|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.1|0.226|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.226|0.100|<0.001
71642849|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.126|0.254|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.254|0.126|<0.001
71642850|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.166|||<|0.001|TWO_SIDED|95.0|0.103|0.229|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.229|0.103|<0.001
71642851|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.206|||<|0.001|TWO_SIDED|95.0|0.146|0.266|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.266|0.146|<0.001
71642852|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.125|0.243|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.243|0.125|<0.001
71702353|NCT00876395|142921698|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1166|TWO_SIDED|95.0|0.73|1.08|||Log Rank|||||1.08|0.73|0.1166
71702354|NCT00876395|142921699|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0049|TWO_SIDED|95.0|0.48|0.91|||Log Rank|||||0.91|0.48|0.0049
71702355|NCT00876395|142921702|SUPERIORITY|||||||0.7276|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.7276
71702356|NCT00876395|142921703|SUPERIORITY|||||||0.4085|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.4085
71702357|NCT00876395|142921704|SUPERIORITY|||||||0.9573|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.9573
71702358|NCT00876395|142921705|SUPERIORITY|||||||0.6382|||||||Exact Cochran-Mantel-Haenzel chi-square|||||||0.6382
71642853|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.4|TWO_SIDED|95.0|-0.036|0.09|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.090|-0.036|0.400
71642854|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.931|TWO_SIDED|95.0|-0.059|0.064|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.064|-0.059|0.931
71642855|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.16|TWO_SIDED|95.0|-0.017|0.102|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.102|-0.017|0.160
71642856|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|-0.024||||0.464|TWO_SIDED|95.0|-0.09|0.041|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.041|-0.090|0.464
71642857|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.623|TWO_SIDED|95.0|-0.047|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.047|0.623
71642858|NCT03086460|142804133|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.197|TWO_SIDED|95.0|-0.021|0.101|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.101|-0.021|0.197
71642859|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.098|TWO_SIDED|95.0|-0.01|0.113|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.113|-0.010|0.098
71642860|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.002|TWO_SIDED|95.0|0.035|0.159|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.159|0.035|0.002
71642861|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.002|TWO_SIDED|95.0|0.039|0.163|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.163|0.039|0.002
71642862|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.063|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.063|<0.001
71642863|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.054|0.171|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.171|0.054|<0.001
71642864|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.162|TWO_SIDED|95.0|-0.018|0.108|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.108|-0.018|0.162
71642865|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.117|TWO_SIDED|95.0|-0.012|0.11|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.012|0.117
71642866|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.02|TWO_SIDED|95.0|0.011|0.13|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.130|0.011|0.020
71642867|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.909|TWO_SIDED|95.0|-0.062|0.07|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.062|0.909
71642868|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.419|TWO_SIDED|95.0|-0.037|0.088|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.088|-0.037|0.419
71642869|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.483|TWO_SIDED|95.0|-0.039|0.083|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.083|-0.039|0.483
71823559|NCT01251614|143150558|SUPERIORITY_OR_OTHER||Difference|1.61||||0.304|TWO_SIDED|95.0|-1.48|4.7|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||4.70|-1.48|0.304
71642870|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.126|TWO_SIDED|95.0|-0.012|0.099|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.099|-0.012|0.126
71642871|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.012|TWO_SIDED|95.0|0.017|0.131|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.131|0.017|0.012
71642872|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.037|TWO_SIDED|95.0|0.004|0.116|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.116|0.004|0.037
71642873|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|0.028|0.003
71642874|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.006|TWO_SIDED|95.0|0.021|0.127|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.127|0.021|0.006
71642875|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.282|TWO_SIDED|95.0|-0.025|0.087|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.025|0.282
71642876|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.554|TWO_SIDED|95.0|-0.039|0.072|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.072|-0.039|0.554
71642877|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.149|TWO_SIDED|95.0|-0.014|0.091|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.091|-0.014|0.149
71642878|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.636|TWO_SIDED|95.0|-0.072|0.044|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.044|-0.072|0.636
71762508|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.22||||0.3||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||0.30
71642879|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.775|TWO_SIDED|95.0|-0.047|0.063|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.063|-0.047|0.775
71642880|NCT03086460|142804134|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.425|TWO_SIDED|95.0|-0.032|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.032|0.425
71642881|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.058|0.187|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.187|0.058|<0.001
71762509|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.26||||0.74||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.74
71762510|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.378||||0.25||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||0.25
71823560|NCT01251614|143150559|SUPERIORITY_OR_OTHER||Difference|-8.88||||0.005|TWO_SIDED|95.0|-14.94|-2.82|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||-2.82|-14.94|0.005
71642882|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.085|0.215|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.215|0.085|<0.001
71642883|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.059|0.189|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.059|<0.001
71642884|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.18|||<|0.001|TWO_SIDED|95.0|0.118|0.242|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.242|0.118|<0.001
71642885|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.177|||<|0.001|TWO_SIDED|95.0|0.115|0.238|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.238|0.115|<0.001
71642886|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.41|TWO_SIDED|95.0|-0.039|0.094|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.094|-0.039|0.410
71642887|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.961|TWO_SIDED|95.0|-0.063|0.066|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.063|0.961
71642888|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.07|TWO_SIDED|95.0|-0.005|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.005|0.070
71642889|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.454|TWO_SIDED|95.0|-0.095|0.043|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.043|-0.095|0.454
71642890|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.37|TWO_SIDED|95.0|-0.035|0.095|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.095|-0.035|0.370
71642891|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.086|TWO_SIDED|95.0|-0.008|0.12|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.120|-0.008|0.086
71642892|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.086||||0.011|TWO_SIDED|95.0|0.02|0.151|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.151|0.020|0.011
71642893|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.005|TWO_SIDED|95.0|0.029|0.164|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.164|0.029|0.005
71642894|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.153|0.021|0.010
71642895|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.208|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.208|0.081|<0.001
71642896|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.127|||<|0.001|TWO_SIDED|95.0|0.065|0.189|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.189|0.065|<0.001
71642897|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.011||||0.74|TWO_SIDED|95.0|-0.055|0.078|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.078|-0.055|0.740
71642898|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.973|TWO_SIDED|95.0|-0.064|0.066|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.066|-0.064|0.973
71642899|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.064|TWO_SIDED|95.0|-0.003|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.003|0.064
71762511|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.69||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
71762512|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A||||
71762513|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.42||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
71642900|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.774|TWO_SIDED|95.0|-0.079|0.059|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.059|-0.079|0.774
71762514|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C||||
71642901|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.151|TWO_SIDED|95.0|-0.018|0.113|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.113|-0.018|0.151
71642902|NCT03086460|142804135|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.076|TWO_SIDED|95.0|-0.006|0.122|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.122|-0.006|0.076
71642903|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.003|TWO_SIDED|95.0|0.039|0.19|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.190|0.039|0.003
71642904|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.055|0.206|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.206|0.055|<0.001
71642905|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.137|||<|0.001|TWO_SIDED|95.0|0.061|0.213|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.213|0.061|<0.001
71642906|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.078|0.223|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.078|<0.001
71642907|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.097|0.24|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.240|0.097|<0.001
71642908|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.679|TWO_SIDED|95.0|-0.061|0.093|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.093|-0.061|0.679
71642909|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.549|TWO_SIDED|95.0|-0.052|0.098|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.098|-0.052|0.549
71642910|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.323|TWO_SIDED|95.0|-0.036|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.036|0.323
71642911|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.866|TWO_SIDED|95.0|-0.073|0.087|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.087|-0.073|0.866
71642912|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.596|TWO_SIDED|95.0|-0.055|0.096|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.055|0.596
71642913|NCT03086460|142804136|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Mean Difference (Final Values)|0.014||||0.72|TWO_SIDED|95.0|-0.061|0.088|||ANCOVA|||||0.088|-0.061|0.720
71642914|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.003|TWO_SIDED|95.0|0.038|0.185|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.185|0.038|0.003
71762515|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0004||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
71762516|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135||||
71762517|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71762518|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y||||
71762519|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.86||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.86
71642915|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.209|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.209|0.057|<0.001
71642916|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.005|TWO_SIDED|95.0|0.032|0.18|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.180|0.032|0.005
71642917|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.081|0.223|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.223|0.081|<0.001
71642918|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.072|0.212|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.212|0.072|<0.001
71642919|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.573|TWO_SIDED|95.0|-0.053|0.096|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.096|-0.053|0.573
71762520|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.08||||0.7||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.7
71642920|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.881|TWO_SIDED|95.0|-0.078|0.067|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.067|-0.078|0.881
71642921|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.261|TWO_SIDED|95.0|-0.03|0.11|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.110|-0.030|0.261
71642922|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.493|TWO_SIDED|95.0|-0.104|0.051|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.051|-0.104|0.493
71642923|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.616|TWO_SIDED|95.0|-0.055|0.092|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.092|-0.055|0.616
71642924|NCT03086460|142804136|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.212|TWO_SIDED|95.0|-0.026|0.118|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.118|-0.026|0.212
71642925|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.361|TWO_SIDED|95.0|-0.039|0.106|||ANCOVA|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.106|-0.039|0.361
71642926|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.065||||0.085|TWO_SIDED|95.0|-0.009|0.138|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.138|-0.009|0.085
71642927|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.036||||0.328|TWO_SIDED|95.0|-0.037|0.109|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.109|-0.037|0.328
71642928|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.002|TWO_SIDED|95.0|0.042|0.182|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.182|0.042|0.002
71642929|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.089||||0.011|TWO_SIDED|95.0|0.02|0.158|||ANCOVA|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.158|0.020|0.011
71642930|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.404|TWO_SIDED|95.0|-0.042|0.104|||ANCOVA|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.104|-0.042|0.404
71642931|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.942|TWO_SIDED|95.0|-0.069|0.074|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.069|0.942
71642932|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.027|TWO_SIDED|95.0|0.009|0.147|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.147|0.009|0.027
71642933|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.463|TWO_SIDED|95.0|-0.104|0.048|||ANCOVA|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.048|-0.104|0.463
71642934|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.2|TWO_SIDED|95.0|-0.025|0.119|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.119|-0.025|0.200
71642935|NCT03086460|142804137|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.037|TWO_SIDED|95.0|0.005|0.146|||ANCOVA|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.146|0.005|0.037
71642936|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.896|TWO_SIDED|95.0|-0.083|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~This secondary efficacy variable was analyzed using the ANCOVA model that was also used for the primary efficacy analysis, without adjusting for multiplicity."||0.073|-0.083|0.896
71642937|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.81|TWO_SIDED|95.0|-0.089|0.07|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.070|-0.089|0.810
71642938|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.882|TWO_SIDED|95.0|-0.084|0.073|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.073|-0.084|0.882
71642939|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.115|TWO_SIDED|95.0|-0.015|0.136|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.136|-0.015|0.115
71642940|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.111|TWO_SIDED|95.0|-0.014|0.134|||ANCOVA|||"Day 14~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.134|-0.014|0.111
71642941|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.911|TWO_SIDED|95.0|-0.083|0.074|||ANCOVA|||"Day 14~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.074|-0.083|0.911
71642942|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|-0.001||||0.985|TWO_SIDED|95.0|-0.078|0.077|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.077|-0.078|0.985
71642943|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.084|TWO_SIDED|95.0|-0.009|0.14|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.140|-0.009|0.084
71642944|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.928|TWO_SIDED|95.0|-0.078|0.086|||ANCOVA|||"Day 14~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.086|-0.078|0.928
71642945|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.078|TWO_SIDED|95.0|-0.008|0.148|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.148|-0.008|0.078
71642946|NCT03086460|142804138|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.089|TWO_SIDED|95.0|-0.01|0.143|||ANCOVA|||"Day 14~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||0.143|-0.010|0.089
71642947|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|18.01|||<|0.001|TWO_SIDED|95.0|4.25|76.37|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment A (CHF 1531 pMDI 6 μg TDD) versus Treatment E (Placebo).~Time to onset of action was analyzed using a Cox proportional hazard model stratified by patient, including treatment and period as a factor, and baseline FEV1 as covariate.~For patients receiving the same treatment twice, the analysis includes only data from the first instance of each treatment."||76.37|4.25|<0.001
71642948|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|31.67|||<|0.001|TWO_SIDED|95.0|7.52|133.47|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||133.47|7.52|<0.001
71642949|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|44.24|||<|0.001|TWO_SIDED|95.0|10.23|191.34|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||191.34|10.23|<0.001
71642950|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|40.32|||<|0.001|TWO_SIDED|95.0|9.54|170.45|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||170.45|9.54|<0.001
71642951|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|22.91|||<|0.001|TWO_SIDED|95.0|5.7|92.06|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment F ( Perforomist® IS 40 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||92.06|5.70|<0.001
71762521|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.58||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.58
71642952|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.195|TWO_SIDED|95.0|0.75|4.13|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment B (CHF 1531 pMDI 12 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.13|0.75|0.195
71642953|NCT03086460|142804139|SUPERIORITY||Risk Ratio (RR)|2.46||||0.037|TWO_SIDED|95.0|1.06|5.72|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||5.72|1.06|0.037
71642954|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.042|TWO_SIDED|95.0|1.03|4.86|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment A (CHF 1531 pMDI 6 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||4.86|1.03|0.042
71642955|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.435|TWO_SIDED|95.0|0.6|3.23|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment C (CHF 1531 pMDI 24 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||3.23|0.60|0.435
71642956|NCT03086460|142804139|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.564|TWO_SIDED|95.0|0.56|2.89|||Regression, Cox|||"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment B (CHF 1531 pMDI 12 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."||2.89|0.56|0.564
71642957|NCT03086460|142804139|SUPERIORITY|"Day 1~Comparison groups were:~Treatment D (CHF 1531 pMDI 48 μg TDD) versus Treatment C (CHF 1531 pMDI 24 μg TDD).~Statistical analysis was performed as described for the statistical analysis #1 of this outcome measure."|Hazard Ratio (HR)|0.91||||0.818|TWO_SIDED|95.0|0.41|2.01|||Regression, Cox|||||2.01|0.41|0.818
71642958|NCT02545283|142804178|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5752|TWO_SIDED|95.0|0.81|1.45|||Log Rank|||||1.45|0.81|0.5752
71642959|NCT02718963|142804223|OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare the Videofluoroscopic swallowing study(VFSS) kinematic variables, VDS, PAS, and high resolution manometry (HRM) variables between the neuromuscular electrical stimulation session and the control session in swallowing thin fluid and thick fluid for healthy, dysphagic and whole participants. Mann-Whitney test was used to compare the differences of VFSS variables, VDS, PAS, and HRM variables between the healthy participants and dysphagic participants.||||< 0.05
71642960|NCT00836472|142804239|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.41||||||90.0|88.43|105.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.10|88.43|
71642961|NCT00836472|142804240|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.78||||||90.0|95.14|102.57|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.57|95.14|
71642962|NCT00836472|142804241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.52||||||90.0|94.44|102.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.78|94.44|
71642963|NCT00836472|142804242|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.08||||||90.0|89.6|98.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.77|89.60|
71642964|NCT00836472|142804243|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.33||||||90.0|92.6|100.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.21|92.60|
71642965|NCT00836472|142804244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.01||||||90.0|92.18|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.00|92.18|
71762522|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.13||||0.44||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.44
71762523|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.07||||0.75||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.75
71762524|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.84||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.84
71642966|NCT01695239|142804245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71642967|NCT01695239|142804245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71642968|NCT01695239|142804245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71642969|NCT03264092|142804301|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.18|||||||Fisher Exact|||||||0.18
71642970|NCT03264092|142804302|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.41|||||||Fisher Exact|||||||0.41
71642971|NCT03264092|142804303|OTHER|This was just a comparative study. No superiority, equivalence or non inferiority analysis was performed.||||||0.45|||||||Fisher Exact|||||||0.45
71642972|NCT02294786|142804342|SUPERIORITY||Difference in Percentages|-4.8||||0.775|TWO_SIDED|95.0|-29.2|20.0|||Chi-squared|||Cycle 1-3 (up to 9 weeks)||20.0|-29.2|0.775
71642973|NCT01667679|142804365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|0.824|<|0.0001|TWO_SIDED|95.0|1.76|5.01|||ANCOVA|||||5.01|1.76|<0.0001
71642974|NCT01667679|142804366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.105||0.0013|TWO_SIDED|95.0|1.47|5.85|||ANCOVA||mild attacks|||5.85|1.47|0.0013
71642975|NCT01667679|142804366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76|STANDARD_ERROR_OF_MEAN|0.971||0.0002|TWO_SIDED|95.0|1.84|5.68|||ANCOVA||moderate/severe attacks|||5.68|1.84|0.0002
71642976|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3549|TWO_SIDED|95.0|0.85|1.6|||ANCOVA||10 minutes post-dose|||1.60|0.85|0.3549
71642977|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0005|TWO_SIDED|95.0|1.2|1.9|||ANCOVA||15 minutes post-dose|||1.90|1.20|0.0005
71642978|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.45|2.21|||ANCOVA||30 minutes post-dose|||2.21|1.45|<0.0001
71642979|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.0002|TWO_SIDED|95.0|1.24|1.96|||ANCOVA||45 minutes post-dose|||1.96|1.24|0.0002
71642980|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0057|TWO_SIDED|95.0|1.1|1.71|||ANCOVA||60 minutes post-dose|||1.71|1.10|0.0057
71642981|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.0654|TWO_SIDED|95.0|0.99|1.61|||ANCOVA||90 minutes post-dose|||1.61|0.99|0.0654
71642982|NCT01667679|142804367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2894|TWO_SIDED|95.0|0.89|1.49|||ANCOVA||120 minutes post-dose|||1.49|0.89|0.2894
71642983|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.1771|TWO_SIDED|95.0|0.76|4.54|||ANCOVA||10 minutes post-dose|||4.54|0.76|0.1771
71642984|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0077|TWO_SIDED|95.0|1.21|3.42|||ANCOVA||15 minutes post-dose|||3.42|1.21|0.0077
71642985|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0003|TWO_SIDED|95.0|1.32|2.5|||ANCOVA||30 minutes post-dose|||2.50|1.32|0.0003
71642986|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.29|2.09|||ANCOVA||45 minutes post-dose|||2.09|1.29|<0.0001
71642987|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0016|TWO_SIDED|95.0|1.14|1.74|||ANCOVA||60 minutes post-dose|||1.74|1.14|0.0016
71642988|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0059|TWO_SIDED|95.0|1.09|1.69|||ANCOVA||90 minutes post-dose|||1.69|1.09|0.0059
71642989|NCT01667679|142804368|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.2717|TWO_SIDED|95.0|0.91|1.42|||ANCOVA||120 minutes post-dose|||1.42|0.91|0.2717
71642990|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.2426|TWO_SIDED|95.0|0.87|1.77|||ANCOVA||10 minutes post-dose|||1.77|0.87|0.2426
71642991|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0069|TWO_SIDED|95.0|1.12|1.99|||ANCOVA||15 minutes post-dose|||1.99|1.12|0.0069
71642992|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94|||<|0.0001|TWO_SIDED|95.0|1.47|2.56|||ANCOVA||30 minutes post-dose|||2.56|1.47|<0.0001
71642993|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0004|TWO_SIDED|95.0|1.26|2.23|||ANCOVA||45 minutes post-dose|||2.23|1.26|0.0004
71642994|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0008|TWO_SIDED|95.0|1.22|2.11|||ANCOVA||60 minutes post-dose|||2.11|1.22|0.0008
71702359|NCT03807843|142921716|OTHER||V184 GMFR/Placebo GMFR Ratio|1.6||||0.004|TWO_SIDED|95.0|1.2|2.1|||Mixed Effects Model|||"Day 28 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 28 was derived from the mixed effects model used to determine GMFR."||2.1|1.2|0.004
71702360|NCT03807843|142921716|OTHER||V184 GMFR/Placebo GMFR Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.8|||Mixed Effects Model|||"Day 56 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 56 was derived from the mixed effects model used to determine GMFR."||2.8|1.5|<0.001
71642995|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0272|TWO_SIDED|95.0|1.04|1.83|||ANCOVA||90 minutes post-dose|||1.83|1.04|0.0272
71702361|NCT03807843|142921716|OTHER||V184 GMFR/Placebo GMFR Ratio|1.3||||0.121|TWO_SIDED|95.0|0.9|1.7|||Mixed Effects Model|||"Day 196 V184 GMFR/Placebo GMFR Ratio~The ratio of V184 GMFR/Placebo GMFR at Day 196 was derived from the mixed effects model used to determine GMFR."||1.7|0.9|0.121
71642996|NCT01667679|142804369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2085|TWO_SIDED|95.0|0.9|1.62|||ANCOVA||120 minutes post-dose|||1.62|0.90|0.2085
71642997|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.021||0.3562|TWO_SIDED|95.0|-0.06|0.02|||ANCOVA||10 minutes post-dose|||0.02|-0.06|0.3562
71642998|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.029||0.0063|TWO_SIDED|94.0|-0.14|-0.02|||ANCOVA||15 minutes post-dose|||-0.02|-0.14|0.0063
71642999|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.26|-0.11|||ANCOVA||30 minutes post-dose|||-0.11|-0.26|< 0.0001
71643000|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0005|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||45 minutes post-dose|||-0.07|-0.26|0.0005
71643001|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.048||0.004|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA||60 minutes post-dose|||-0.05|-0.24|0.0040
71643002|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0333|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA||90 minutes post-dose|||-0.01|-0.21|0.0333
71643003|NCT01667679|142804371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.052||0.4031|TWO_SIDED|95.0|-0.15|0.06|||ANCOVA||120 minutes post-dose|||0.06|-0.15|0.4031
71643004|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||0.0181|TWO_SIDED|95.0|-0.08|-0.01|||ANCOVA||10 minutes post-dose|||-0.01|-0.08|0.0181
71643005|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||15 minutes post-dose|||-0.04|-0.14|0.0003
71643006|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.23|-0.09|||ANCOVA||30 minutes post-dose|||-0.09|-0.23|< 0.0001
71643007|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|-0.25|-0.08|||ANCOVA||45 minutes post-dose|||-0.08|-0.25|0.0001
71643008|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.0006|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA||60 minutes post-dose|||-0.07|-0.26|0.0006
71643009|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.048||0.0189|TWO_SIDED|95.0|-0.21|-0.02|||ANCOVA||90 minutes post-dose|||-0.02|-0.21|0.0189
71643010|NCT01667679|142804372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.1704|TWO_SIDED|95.0|-0.17|0.03|||ANCOVA||120 minutes post-dose|||0.03|-0.17|0.1704
71643011|NCT02777580|142804402|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71643012|NCT02777580|142804403|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.62|1.48||||||||1.48|0.62|
71643013|NCT02777580|142804404|OTHER||Risk Ratio (RR)|4.57|||||TWO_SIDED|95.0|0.58|35.8||||||||35.8|0.58|
71643014|NCT02777580|142804405|OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|0.25|6.48||||||||6.48|0.25|
71643015|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.13|||||TWO_SIDED|95.0|-50.4|-5.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Fasting Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Fasting Value.||-5.86|-50.40|
71643016|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.16|||||TWO_SIDED|95.0|-51.68|-6.64|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.||-6.64|-51.68|
71643017|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.58|||||TWO_SIDED|95.0|-62.25|-10.9|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.||-10.90|-62.25|
71643018|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.41|||||TWO_SIDED|95.0|-72.8|-18.03|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.||-18.03|-72.80|
71643019|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.35|||||TWO_SIDED|95.0|-50.84|-7.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.||-7.86|-50.84|
71643020|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.14|||||TWO_SIDED|95.0|-45.8|-6.49|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean||-6.49|-45.80|
71643021|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0|||||TWO_SIDED|95.0|-55.41|-8.58|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.||-8.58|-55.41|
71643022|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.96|||||TWO_SIDED|95.0|-66.64|-15.29|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.||-15.29|-66.64|
71643023|NCT01929863|142804553|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.76|||||TWO_SIDED|95.0|-54.67|-14.85|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.||-14.85|-54.67|
71643024|NCT01929863|142804554|SUPERIORITY_OR_OTHER||Ratio|1.013|||||TWO_SIDED|90.0|0.912|1.125|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-10 h).|||1.125|0.912|
71643025|NCT01929863|142804555|SUPERIORITY_OR_OTHER||Ratio|1.036|||||TWO_SIDED|90.0|0.937|1.145|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Cmax.|||1.145|0.937|
71643026|NCT02911701|142804570|SUPERIORITY|||||||0.3|||||||maxim|||||||0.3
71643027|NCT00830024|142804589|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|98.75||||||90.0|93.35|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|93.35|
71643028|NCT00830024|142804590|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.94||||||90.0|91.76|100.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.3|91.76|
71643029|NCT00830024|142804591|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.89||||||90.0|91.67|100.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.31|91.67|
71643030|NCT03804983|142804642|OTHER|Analysis of Variance||||||0.178||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.178
71643031|NCT03804983|142804643|OTHER|Analysis of Variance||||||0.145||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.145
71643032|NCT03804983|142804644|OTHER|Analysis of Variance||||||0.304||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.304
71643033|NCT03804983|142804645|OTHER|Analysis of Variance||||||0.131||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.131
71643034|NCT03804983|142804647|OTHER|Analysis of Variance||||||0.206||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.206
71643035|NCT03804983|142804648|OTHER|Analysis of Variance||||||0.335||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.335
71643036|NCT03804983|142804649|OTHER|Analysis of Variance||||||0.637||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.637
71643037|NCT03804983|142804650|OTHER|Analysis of Variance||||||0.347||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.347
71643038|NCT03804983|142804651|OTHER|Analysis of Variance||||||0.057||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.057
71643039|NCT03804983|142804652|OTHER|Analysis of Variance||||||0.435||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.435
71643040|NCT03804983|142804653|OTHER|Analysis of Variance||||||0.135||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.135
71643041|NCT03804983|142804654|OTHER|Analysis of Variance||||||0.271||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.271
71643042|NCT03804983|142804655|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
71643043|NCT03804983|142804657|OTHER|Analysis of Variance||||||1||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||1.0
71643044|NCT03804983|142804658|OTHER|Analysis of Variance||||||0.294||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.294
71643045|NCT03804983|142804659|OTHER|Analysis of Variance||||||0.584||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.584
71643046|NCT03804983|142804660|OTHER|Analysis of Variance||||||0.69||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.69
71643047|NCT03804983|142804661|OTHER|Analysis of Variance||||||0.066||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.066
71762525|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.11||||0.67||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.67
71762526|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.002||||0.99||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.99
71643048|NCT03804983|142804662|OTHER|Analysis of Variance||||||0.904||||||All outcomes were analyzed using repeated measure ANOVA comparing baseline to the studied period(i.e., ski admission or home use), grouped by treatment. Significance level was set at a P-Value\<0.05|ANOVA|||||||0.904
71643049|NCT03100344|142804673|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward-Rogers|||||0.0|-27.3|0.051
71643050|NCT03100344|142804673|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||||-3.2|-30.2|0.016
71762527|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.62
71762528|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.17||||0.36||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||0.36
71643051|NCT03100344|142804673|OTHER|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||||6.8|-20.5|0.322
71643052|NCT03100344|142804674|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.034|TWO_SIDED|95.0|2.0|35.8|||Cochran-Mantel-Haenszel|||||35.8|2.0|0.034
71643053|NCT03100344|142804674|SUPERIORITY||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|14.7|48.2|||Cochran-Mantel-Haenszel|||||48.2|14.7|<0.001
71643054|NCT03100344|142804674|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.154|TWO_SIDED|95.0|-4.2|28.6|||Cochran-Mantel-Haenszel|||||28.6|-4.2|0.154
71643055|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|10.9||||0.062|TWO_SIDED|95.0|-0.4|22.2|||Cochran-Mantel-Haenszel|||Week 1||22.2|-0.4|0.062
71643056|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.042|TWO_SIDED|95.0|0.8|23.6|||Cochran-Mantel-Haenszel|||Week 1||23.6|0.8|0.042
71643057|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.307|TWO_SIDED|95.0|-4.7|15.0|||Cochran-Mantel-Haenszel|||Week 1||15.0|-4.7|0.307
71643058|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.003|TWO_SIDED|95.0|9.3|38.7|||Cochran-Mantel-Haenszel|||Week 2||38.7|9.3|0.003
71643059|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.001|TWO_SIDED|95.0|11.4|40.9|||Cochran-Mantel-Haenszel|||Week 2||40.9|11.4|0.001
71643060|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.011|TWO_SIDED|95.0|4.9|33.1|||Cochran-Mantel-Haenszel|||Week 2||33.1|4.9|0.011
71643061|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|27.6|||<|0.001|TWO_SIDED|95.0|13.5|41.7|||Cochran-Mantel-Haenszel|||Week 4||41.7|13.5|<0.001
71643062|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|40.3|||<|0.001|TWO_SIDED|95.0|25.7|54.8|||Cochran-Mantel-Haenszel|||Week 4||54.8|25.7|<0.001
71643063|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|31.6|||<|0.001|TWO_SIDED|95.0|17.4|45.8|||Cochran-Mantel-Haenszel|||Week 4||45.8|17.4|<0.001
71643064|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.018|TWO_SIDED|95.0|4.2|37.1|||Cochran-Mantel-Haenszel|||Week 8||37.1|4.2|0.018
71643065|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|1|TWO_SIDED|95.0|27.6|59.9|||Cochran-Mantel-Haenszel|||Week 8||59.9|27.6|<0001
71643066|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|9.7|42.6|||Cochran-Mantel-Haenszel|||Week 8||42.6|9.7|0.003
71762529|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.003||||0.99||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.99
71762530|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.2||||0.24||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||0.24
71643067|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.007|TWO_SIDED|95.0|7.3|41.4|||Cochran-Mantel-Haenszel|||Week 12||41.4|7.3|0.007
71762531|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.62
71762532|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.08||||0.69||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||0.69
71762533|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.13||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.60
71762534|NCT00488683|143027033|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.01||||0.95||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||0.95
71762535|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71762536|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A||||
71762537|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71762538|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C||||
71762539|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
71762540|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135||||
71762541|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
71762542|NCT00488683|143027033|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y||||
71762543|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.14||||0.68||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.68
71762544|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.44||||0.09||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.09
71762545|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.11||||0.69||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.69
71762546|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.38||||0.2||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.20
71762547|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.88||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||0.88
71762548|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.12||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||0.12
71762549|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.25||||0.37||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||0.37
71643068|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|43.6|||<|0.001|TWO_SIDED|95.0|27.4|59.9|||Cochran-Mantel-Haenszel|||Week 12||59.9|27.4|<0.001
71643069|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.03|TWO_SIDED|95.0|2.4|35.9|||Cochran-Mantel-Haenszel|||Week 12||35.9|2.4|0.030
71643070|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.4|50.2|||Cochran-Mantel-Haenszel|||Week 16||50.2|16.4|<0.001
71643071|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|47.2|||<|0.001|TWO_SIDED|95.0|31.2|63.2|||Cochran-Mantel-Haenszel|||Week 16||63.2|31.2|<0.001
71643072|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|22.8||||0.01|TWO_SIDED|95.0|6.1|39.4|||Cochran-Mantel-Haenszel|||Week 16||39.4|6.1|0.010
71643073|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|26.3||||0.004|TWO_SIDED|95.0|9.2|43.5|||Cochran-Mantel-Haenszel|||Week 20||43.5|9.2|0.004
71643074|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|36.7|||<|0.001|TWO_SIDED|95.0|20.1|53.3|||Cochran-Mantel-Haenszel|||Week 20||53.3|20.1|<0.001
71643075|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.007|TWO_SIDED|95.0|7.6|41.4|||Cochran-Mantel-Haenszel|||Week 20||41.4|7.6|0.007
71643076|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.022|TWO_SIDED|95.0|3.6|38.1|||Cochran-Mantel-Haenszel|||Week 24||38.1|3.6|0.022
71643077|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|24.3||||0.007|TWO_SIDED|95.0|7.4|41.3|||Cochran-Mantel-Haenszel|||Week 24||41.3|7.4|0.007
71643078|NCT03100344|142804675|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.05|TWO_SIDED|95.0|0.4|34.4|||Cochran-Mantel-Haenszel|||Week 24||34.4|0.4|0.050
71702362|NCT01312129|142921719|SUPERIORITY_OR_OTHER||||||=|0.05|TWO_SIDED|||||=0.05 is the actual computed p-value via the ANOVA.|ANOVA|The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo \& Sulfasalazine .||||||=.05
71702363|NCT02034591|142921737|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.682|||||TWO_SIDED|90.0|0.621|0.748||||||||0.748|0.621|
71886160|NCT00662792|143292981|SUPERIORITY||Difference of adjusted means|24.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|19.2|29.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||29.2|19.2|<.0001
71643079|NCT03100344|142804676|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-14.4||||0.017|TWO_SIDED|95.0|-26.2|-2.7|||Kenward Roger|||||-2.7|-26.2|0.017
71643080|NCT03100344|142804676|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-11.3||||0.058|TWO_SIDED|95.0|-23.1|0.4|||Kenward Roger|||||0.4|-23.1|0.058
71643081|NCT03100344|142804676|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-20.0|||<|0.001|TWO_SIDED|95.0|-31.6|-8.3|||Kenward Roger|||||-8.3|-31.6|<0.001
71643082|NCT03100344|142804677|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-9.6||||0.016|TWO_SIDED|95.0|-17.5|-1.8|||Kenward Roger|||||-1.8|-17.5|0.016
71643083|NCT03100344|142804677|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-12.8||||0.001|TWO_SIDED|95.0|-20.6|-5.1|||Kenward Roger|||||-5.1|-20.6|0.001
71643084|NCT03100344|142804677|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-7.6||||0.058|TWO_SIDED|95.0|-15.4|0.3|||Kenward Roger|||||0.3|-15.4|0.058
71643085|NCT03100344|142804678|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-24.5|||<|0.001|TWO_SIDED|95.0|-37.8|-11.2|||Kenward Roger|||||-11.2|-37.8|<0.001
71643086|NCT03100344|142804678|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-31.7|||<|0.001|TWO_SIDED|95.0|-44.9|-18.6|||Kenward Roger|||||-18.6|-44.9|<0.001
71643087|NCT03100344|142804678|OTHER|mixed-effect model for repeated measures|mean difference of percentage changes|-25.1|||<|0.001|TWO_SIDED|95.0|-38.4|-11.8|||Kenward Roger|||||-11.8|-38.4|<0.001
71643088|NCT03100344|142804679|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.0|||<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||Kenward Roger|||||-1.0|-3.1|<0.001
71643089|NCT03100344|142804679|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-2.3|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Kenward Roger|||||-1.3|-3.4|<0.001
71643090|NCT03100344|142804679|OTHER|mixed-effect model for repeated measures|mean difference of absolute changes|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||||-0.9|-3.0|<0.001
71643091|NCT03100344|142804680|OTHER||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||At week 1||5.1|-4.9|0.970
71643092|NCT03100344|142804680|OTHER||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||At week 1||7.5|-4.1|0.574
71643093|NCT03100344|142804680|OTHER||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||At week 1||1.7|-5.2|0.311
71643094|NCT03100344|142804680|OTHER||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||At week 24||19.8|-11.3|0.598
71643095|NCT03100344|142804680|OTHER||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||At week 24||31.4|-0.4|0.066
71643096|NCT03100344|142804680|OTHER||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||At week 24||16.9|-13.5|0.826
71643097|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
71643098|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
71643099|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
71643100|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
71643101|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
71643102|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
71643103|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
71643104|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
71643105|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
71643106|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
71643107|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
71643108|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.032|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 12||28.2|-0.3|0.032
71643109|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
71643110|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
71643111|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
71643112|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
71643113|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
71643114|NCT03100344|142804680|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
71762550|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.28||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||0.36
71643115|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.487|TWO_SIDED|95.0|-6.8|14.3|||Cochran-Mantel-Haenszel|||Week 1||14.3|-6.8|0.487
71643116|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.6|26.5|||Cochran-Mantel-Haenszel|||Week 1||26.5|1.6|0.033
71643117|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.053|TWO_SIDED|95.0|0.2|23.8|||Cochran-Mantel-Haenszel|||Week 1||23.8|0.2|0.053
71643118|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|18.5||||0.021|TWO_SIDED|95.0|3.2|33.8|||Cochran-Mantel-Haenszel|||Week 2||33.8|3.2|0.021
71643119|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.027|TWO_SIDED|95.0|2.4|32.3|||Cochran-Mantel-Haenszel|||Week 2||32.3|2.4|0.027
71643120|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|22.7||||0.006|TWO_SIDED|95.0|7.3|38.1|||Cochran-Mantel-Haenszel|||Week 2||38.1|7.3|0.006
71643121|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.086|TWO_SIDED|95.0|-1.7|32.2|||Cochran-Mantel-Haenszel|||Week 4||32.2|-1.7|0.086
71643122|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|26.2||||0.004|TWO_SIDED|95.0|9.3|43.1|||Cochran-Mantel-Haenszel|||Week 4||43.1|9.3|0.004
71643123|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.05|TWO_SIDED|95.0|0.5|34.2|||Cochran-Mantel-Haenszel|||Week 4||34.2|0.5|0.050
71643124|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|20.7||||0.023|TWO_SIDED|95.0|3.3|38.1|||Cochran-Mantel-Haenszel|||Week 8||38.1|3.3|0.023
71643125|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
71643126|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.002|TWO_SIDED|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8||45.0|10.7|0.002
71643127|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|19.3||||0.041|TWO_SIDED|95.0|1.3|37.3|||Cochran-Mantel-Haenszel|||Week 12||37.3|1.3|0.041
71643128|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|27.9||||0.003|TWO_SIDED|95.0|10.4|45.4|||Cochran-Mantel-Haenszel|||Week 12||45.4|10.4|0.003
71643129|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.063|TWO_SIDED|95.0|-0.5|35.2|||Cochran-Mantel-Haenszel|||Week 12||35.2|-0.5|0.063
71643130|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 16||35.6|-0.4|0.064
71643131|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|22.6||||0.016|TWO_SIDED|95.0|4.9|40.3|||Cochran-Mantel-Haenszel|||Week 16||40.3|4.9|0.016
71643132|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.041|TWO_SIDED|95.0|1.3|36.9|||Cochran-Mantel-Haenszel|||Week 16||36.9|1.3|0.041
71643133|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|17.6||||0.064|TWO_SIDED|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 20||35.6|-0.4|0.064
71643134|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.005|TWO_SIDED|95.0|8.6|43.4|||Cochran-Mantel-Haenszel|||Week 20||43.4|8.6|0.005
71643135|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.064|TWO_SIDED|95.0|-0.6|35.0|||Cochran-Mantel-Haenszel|||Week 20||35.0|-0.6|0.064
71643136|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|15.9||||0.094|TWO_SIDED|95.0|-2.0|33.8|||Cochran-Mantel-Haenszel|||Week 24||33.8|-2.0|0.094
71643137|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.014|TWO_SIDED|95.0|5.1|39.6|||Cochran-Mantel-Haenszel|||Week 24||39.6|5.1|0.014
71643138|NCT03100344|142804681|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.273|TWO_SIDED|95.0|-7.7|28.0|||Cochran-Mantel-Haenszel|||Week 24||28.0|-7.7|0.273
71643139|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.979|TWO_SIDED|95.0|-6.8|7.0|||Cochran-Mantel-Haenszel|||Week 1||7.0|-6.8|0.979
71643140|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.668|TWO_SIDED|95.0|-5.8|9.0|||Cochran-Mantel-Haenszel|||Week 1||9.0|-5.8|0.668
71643141|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.8|9.2|||Cochran-Mantel-Haenszel|||Week 1||9.2|-5.8|0.658
71643142|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.69|TWO_SIDED|95.0|-8.0|12.2|||Cochran-Mantel-Haenszel|||Week 2||12.2|-8.0|0.690
71643143|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.521|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel|||Week 2||13.7|-6.9|0.521
71643144|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.033|TWO_SIDED|95.0|1.5|26.5|||Cochran-Mantel-Haenszel|||Week 2||26.5|1.5|0.033
71643145|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.172|TWO_SIDED|95.0|-3.1|18.0|||Cochran-Mantel-Haenszel|||Week 4||18.0|-3.1|0.172
71643146|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.014|TWO_SIDED|95.0|3.7|27.7|||Cochran-Mantel-Haenszel|||Week 4||27.7|3.7|0.014
71643147|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.002|TWO_SIDED|95.0|8.2|33.9|||Cochran-Mantel-Haenszel|||Week 4||33.9|8.2|0.002
71643148|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.404|TWO_SIDED|95.0|-7.5|18.8|||Cochran-Mantel-Haenszel|||Week 8||18.8|-7.5|0.404
71643149|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|24.5||||0.003|TWO_SIDED|95.0|9.4|39.6|||Cochran-Mantel-Haenszel|||Week 8||39.6|9.4|0.003
71643150|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|14.1||||0.059|TWO_SIDED|95.0|-0.1|28.2|||Cochran-Mantel-Haenszel|||Week 8||28.2|-0.1|0.059
71643151|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.222|TWO_SIDED|95.0|-5.6|25.0|||Cochran-Mantel-Haenszel|||Week 12||25.0|-5.6|0.222
71643152|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|26.1||||0.003|TWO_SIDED|95.0|10.0|42.3|||Cochran-Mantel-Haenszel|||Week 12||42.3|10.0|0.003
71643153|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.22|TWO_SIDED|95.0|3.3|35.0|||Cochran-Mantel-Haenszel|||Week 12||35.0|3.3|0.22
71643154|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|13.3||||0.111|TWO_SIDED|95.0|-2.8|29.3|||Cochran-Mantel-Haenszel|||Week 16||29.3|-2.8|0.111
71643155|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|13.2|46.0|||Cochran-Mantel-Haenszel|||Week 16||46.0|13.2|<0.001
71643156|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.04|TWO_SIDED|95.0|1.3|33.6|||Cochran-Mantel-Haenszel|||Week 16||33.6|1.3|0.040
71643157|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.262|TWO_SIDED|95.0|-7.3|27.4|||Cochran-Mantel-Haenszel|||Week 20||27.4|-7.3|0.262
71643158|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.327|TWO_SIDED|95.0|-8.4|25.7|||Cochran-Mantel-Haenszel|||Week 20||25.7|-8.4|0.327
71643159|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|15.7||||0.083|TWO_SIDED|95.0|-1.7|33.1|||Cochran-Mantel-Haenszel|||Week 20||33.1|-1.7|0.083
71643160|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.255|TWO_SIDED|95.0|-7.0|27.2|||Cochran-Mantel-Haenszel|||Week 24||27.2|-7.0|0.255
71643161|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.034|TWO_SIDED|95.0|2.2|35.9|||Cochran-Mantel-Haenszel|||Week 24||35.9|2.2|0.034
71643162|NCT03100344|142804682|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.053|TWO_SIDED|95.0|0.3|34.6|||Cochran-Mantel-Haenszel|||Week 24||34.6|0.3|0.053
71643163|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
71643164|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
71643165|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-4.8|4.8|||Cochran-Mantel-Haenszel|||Week 1||4.8|-4.8|0.985
71643166|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.154|TWO_SIDED|95.0|-8.4|1.2|||Cochran-Mantel-Haenszel|||Week 2||1.2|-8.4|0.154
71643167|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
71643168|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.978|TWO_SIDED|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2||6.6|-6.8|0.978
71643169|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.602|TWO_SIDED|95.0|-7.5|4.3|||Cochran-Mantel-Haenszel|||Week 4||4.3|-7.5|0.602
71643170|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.5|11.4|||Cochran-Mantel-Haenszel|||Week 4||11.4|-4.5|0.413
71643171|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.658|TWO_SIDED|95.0|-5.7|9.1|||Cochran-Mantel-Haenszel|||Week 4||9.1|-5.7|0.658
71643172|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.307|TWO_SIDED|95.0|-3.2|10.3|||Cochran-Mantel-Haenszel|||Week 8||10.3|-3.2|0.307
71643173|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.002|TWO_SIDED|95.0|6.9|27.8|||Cochran-Mantel-Haenszel|||Week 8||27.8|6.9|0.002
71643174|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.054|TWO_SIDED|95.0|0.1|17.4|||Cochran-Mantel-Haenszel|||Week 8||17.4|0.1|0.054
71643175|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.325|TWO_SIDED|95.0|-5.4|16.5|||Cochran-Mantel-Haenszel|||Week 12||16.5|-5.4|0.325
71643176|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.019|TWO_SIDED|95.0|3.1|28.1|||Cochran-Mantel-Haenszel|||Week 12||28.1|3.1|0.019
71643177|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.011|TWO_SIDED|95.0|4.5|30.5|||Cochran-Mantel-Haenszel|||Week 12||30.5|4.5|0.011
71643178|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|9.2||||0.153|TWO_SIDED|95.0|-3.2|21.7|||Cochran-Mantel-Haenszel|||Week 16||21.7|-3.2|0.153
71643179|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|||Week 16||38.4|10.3|0.001
71643180|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.069|TWO_SIDED|95.0|-0.7|25.1|||Cochran-Mantel-Haenszel|||Week 16||25.1|-0.7|0.069
71762551|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A||||
71762552|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.2||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C||||
71762553|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135||||
71823561|NCT01251614|143150560|SUPERIORITY_OR_OTHER||Difference|-28.3||||0.113|TWO_SIDED|95.0|-60.6|4.0|||Chi-squared|||"The difference between the combined adalimumab 0.8 mg/kg + MTX groups versus the adalimumab 0.4 mg/kg group.~Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were to be 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank."||4.0|-60.6|0.113
71823562|NCT01251614|143150561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.343|TWO_SIDED|95.0|0.66|3.17|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.17|0.66|0.343
71823563|NCT01251614|143150561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.276|TWO_SIDED|95.0|0.71|3.21|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.||3.21|0.71|0.276
71823564|NCT04672460|143150581|OTHER||Ratio (Test/Reference) of Adjusted Means|105.16|||||TWO_SIDED|90.0|99.0|111.7|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||111.70|99.00|
71823565|NCT04672460|143150582|OTHER||Ratio (Test/Reference) of Adjusted Means|136.62|||||TWO_SIDED|90.0|125.05|149.27|||Mixed Models Analysis|||Treatment A were reference; treatment B were test.||149.27|125.05|
71823566|NCT04672460|143150583|OTHER||Ratio (Test/Reference) of Adjusted Means|87.97|||||TWO_SIDED|90.0|81.82|94.58|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||94.58|81.82|
71823567|NCT04672460|143150584|OTHER||Ratio (Test/Reference) of Adjusted Means|58.26|||||TWO_SIDED|90.0|51.55|65.84|||Mixed Models Analysis|||Treatment B were reference; treatment C were test.||65.84|51.55|
71823568|NCT03575962|143150592|OTHER||Ratio of geometric least square mean|1.1169|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
71823569|NCT03575962|143150593|OTHER||Ratio of geometric least square mean|1.1556|||||TWO_SIDED|90.0|0.99|1.35||||||||1.35|0.99|
71823570|NCT03371108|143150618|EQUIVALENCE|The determination of equivalence was defined by the US-FDA as a confidence interval that was contained within the equivalence limits of +/- 10.7.|Risk Difference (RD)|-2.1|STANDARD_ERROR_OF_MEAN|3.39|||TWO_SIDED|90.0|-7.6|3.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||3.5|-7.6|
71823571|NCT02790606|143150633|SUPERIORITY|||||||0.0021|||||||Exact binomial test|||"The primary safety endpoint is evaluated against a PG of 88%, which was derived from safety event rates of PTA in published literature.~Hypothesis: The safety rate in subjects treated with the COVERA™ Vascular Covered Stent (following PTA) at 30 days post-index procedure is greater than that of the PG of 88%. 109 treated subjects \[104 evaluable\] will give 99% power with one-sided type I error = 0.05."||||0.0021
71823572|NCT02790606|143150634|SUPERIORITY||||||<|0.0001||||||The p-value is compared to the PG (40%) and computed using the exact binomial test.|Exact binomial test|||"The primary effectiveness endpoint is evaluated against a PG of 40%, which was derived from clinical literature as well as other pivotal and post-market studies of stent grafts at the graft-vein anastomosis of AV access patients dialyzing with an AV graft. 89% estimated power for primary endpoint.~Hypothesis: The proportion of subjects treated with the COVERA™ Vascular Covered Stent (following PTA) with respect to TLPP through 6 months post-index procedure is greater than that of the PG of 40%."||||<0.0001
71823573|NCT05176353|143150671|SUPERIORITY|||||||0.86|||||||Z-score test for person-time rates|||||||0.86
71823574|NCT05176353|143150672|SUPERIORITY|||||||0.05|||||||Z-score test for person-time rates|||||||0.05
71823575|NCT05176353|143150673|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||0.59
71823576|NCT05176353|143150674|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
71643181|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|12.9||||0.07|TWO_SIDED|95.0|-0.8|26.6|||Cochran-Mantel-Haenszel|||Week 20||26.6|-0.8|0.070
71762554|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.15||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y||||
71823577|NCT05176353|143150675|SUPERIORITY|||||||0.2|||||||Z-score test for person-time rates|||||||0.20
71823578|NCT05176353|143150676|SUPERIORITY|||||||0.03|||||||Z-score test for person-time rates|||||||0.03
71823579|NCT05176353|143150677|SUPERIORITY||||||<|0.01|||||||Z-score test for person-time rates|||||||<0.01
71823580|NCT05176353|143150678|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||.05
71823581|NCT01764386|143150686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.52|||<|0.0001|TWO_SIDED|95.0|-9.88|-7.15|||ANCOVA|||||-7.15|-9.88|<0.0001
71823582|NCT01764386|143150687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||<|0.0001|TWO_SIDED|95.0|16.6|116.3|||Regression, Logistic|||||116.3|16.6|<0.0001
71823583|NCT01764386|143150688|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.4|||<|0.0001|TWO_SIDED|95.0|6.0|76.7|||Regression, Logistic|||||76.7|6.0|<0.0001
71823584|NCT01764386|143150690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.65|||<|0.0001|TWO_SIDED|95.0|-10.07|-7.24|||ANCOVA|||||-7.24|-10.07|<0.0001
71823585|NCT01764386|143150691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|||<|0.0001|TWO_SIDED|95.0|-7.14|-3.5|||ANCOVA|||||-3.50|-7.14|<0.0001
71823586|NCT01764386|143150692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.4||||0.0019|TWO_SIDED|95.0|-29.5|-3.3|||ANCOVA|||||-3.3|-29.5|0.0019
71762555|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|1.0||||||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
71762556|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|1.0||||||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
71762557|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C||||
71762558|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135||||
71762559|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y||||
71762560|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.08||||0.79||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.79
71762561|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.35||||0.16||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.16
71762562|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.48||||0.1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.10
71762563|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.98||||0.003||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.003
71762564|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.03||||0.91||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||0.91
71762565|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.57||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||0.01
71762566|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.39||||0.19||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||0.19
71762567|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.89||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||0.04
71762568|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A||||
71762569|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C||||
71762570|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.23||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135||||
71762571|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.96||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y||||
71762572|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.18||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.46
71643182|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.006|TWO_SIDED|95.0|6.5|35.3|||Cochran-Mantel-Haenszel|||Week 20||35.3|6.5|0.006
71762573|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.9||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.90
71762574|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.51||||0.008||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.008
71762575|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.42||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.08
71762576|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.15||||0.52||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||0.52
71762577|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.27||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||0.18
71762578|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.37||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||0.07
71823587|NCT01764386|143150693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.9686|TWO_SIDED|95.0|-5.96|5.73|||ANCOVA|||||5.73|-5.96|0.9686
71762579|NCT00488683|143027034|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.14||||0.55||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||0.55
71762580|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A||||
71762581|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.0007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C||||
71762582|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135||||
71762583|NCT00488683|143027034|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y||||
71762584|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.45||||0.0006||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0006
71762585|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.41||||0.0021||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||0.0021
71762586|NCT00488683|143027035|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age||||
71762587|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.15||||0.53||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination||||0.53
71762588|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.21||||0.26||95.0|||||Parametric correlation||Values from Groups 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
71762589|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.05||||0.84||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.84
71762590|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Spearman Correlation Coefficient|0.22||||0.26||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||0.26
71643183|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.052|TWO_SIDED|95.0|0.3|27.7|||Cochran-Mantel-Haenszel|||Week 20||27.7|0.3|0.052
71762591|NCT00488683|143027035|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
71762592|NCT00488683|143027035|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination||||
71762593|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.33|||<|0.001||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
71762594|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.46|||<|0.001||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
71762595|NCT00488683|143027035|SUPERIORITY_OR_OTHER||R-square|0.11|||<|0.001||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age||||<0.001
71762596|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.24||||0.06||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.06
71762597|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.5|||<|0.001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||<0.001
71643184|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.069|TWO_SIDED|95.0|-0.7|26.3|||Cochran-Mantel-Haenszel|||Week 24||26.3|-0.7|0.069
71643185|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|19.1||||0.011|TWO_SIDED|95.0|4.9|33.3|||Cochran-Mantel-Haenszel|||Week 24||33.3|4.9|0.011
71762598|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.31||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.01
71762599|NCT00488683|143027035|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.2||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||0.10
71762600|NCT00488683|143027035|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear|||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
71762601|NCT00488683|143027035|SUPERIORITY_OR_OTHER||R-square|0.25||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination||||
71762602|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|0.04||||0.7||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.70
71762603|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.04||||0.63||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.63
71762604|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.74
71762605|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.74
71762606|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.18||||0.05||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||0.05
71762607|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.07||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||0.36
71643186|NCT03100344|142804683|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.083|TWO_SIDED|95.0|-1.3|25.7|||Cochran-Mantel-Haenszel|||Week 24||25.7|-1.3|0.083
71762608|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.11||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||0.18
71762609|NCT00488683|143027041|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.02||||0.82||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||0.82
71762610|NCT00488683|143027041|SUPERIORITY_OR_OTHER||R-square|0.0013||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A||||
71643187|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1||5.1|-4.9|0.970
71762611|NCT00488683|143027041|SUPERIORITY_OR_OTHER||R-square|0.0014||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C||||
71762612|NCT00488683|143027041|SUPERIORITY_OR_OTHER||R-square|0.0008||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135||||
71762613|NCT00488683|143027041|SUPERIORITY_OR_OTHER||R-square|0.0009||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y||||
71762614|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.34||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
71762615|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
71762616|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.09||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C||||
71762617|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
71762618|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.22||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
71762619|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
71762620|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.74||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
71643188|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.574|TWO_SIDED|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1||7.5|-4.1|0.574
71643189|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.311|TWO_SIDED|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||Week 1||1.7|-5.2|0.311
71643190|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.558|TWO_SIDED|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2||4.1|-7.7|0.558
71643191|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.413|TWO_SIDED|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2||11.6|-4.7|0.413
71762621|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.53||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
71823588|NCT01764386|143150694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.0001|TWO_SIDED|95.0|1.99|6.06|||ANCOVA|||||6.06|1.99|0.0001
71823589|NCT01764386|143150695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.1706|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|||||0.9|-4.9|0.1706
71823590|NCT01764386|143150696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.716|TWO_SIDED|95.0|-2.6|1.8|||ANCOVA|||||1.8|-2.6|0.7160
71823591|NCT01764386|143150697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.0913|TWO_SIDED|95.0|-0.3|4.3|||ANCOVA|||||4.3|-0.3|0.0913
71823592|NCT01764386|143150698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.0016|TWO_SIDED|95.0|-7.2|-1.7|||ANCOVA|||||-1.7|-7.2|0.0016
71823593|NCT01764386|143150699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.0004|TWO_SIDED|95.0|-6.2|-2.0|||ANCOVA|||||-2.0|-6.2|0.0004
71823594|NCT01764386|143150700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.0003|TWO_SIDED|95.0|-1.7|-0.7|||ANCOVA|||||-0.7|-1.7|0.0003
71823595|NCT01764386|143150701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.8|-6.0|||ANCOVA|||||-6.0|-9.8|<0.0001
71823596|NCT01764386|143150702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||||-1.1|-3.1|<0.0001
71823597|NCT01764386|143150703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.0001|TWO_SIDED|95.0|13.45|21.36|||ANCOVA|||||21.36|13.45|<0.0001
71823598|NCT03929302|143150708|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
71762622|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
71762623|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.14||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A||||
71762624|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
71762625|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C||||
71762626|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.9||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
71823599|NCT03929302|143150708|SUPERIORITY||Mean Difference (Final Values)|1.57||||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
71643192|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.543|TWO_SIDED|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.0|-7.7|0.543
71762627|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.78||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135||||
71823600|NCT03929302|143150708|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.642|TWO_SIDED||||||Regression, Linear|||||||0.642
71823601|NCT03815916|143150709|SUPERIORITY||Mean Difference (Final Values)|0.3865||||0.1077|TWO_SIDED||||||t-test, 2 sided|||The primary efficacy endpoint is the mean change in the average NAD+/NADH brain ratio from baseline to Week 12 using a partial volume coil 31P-MRS data on the Per Protocol Treatment Population. A paired t-test will be used to analyze the mean change from baseline.||||0.1077
71823602|NCT03566680|143150799|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71823603|NCT03566680|143150800|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71823604|NCT03566680|143150801|EQUIVALENCE||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71823605|NCT03566680|143150802|EQUIVALENCE|||||||0.73|||||||t-test, 2 sided|||||||0.73
71823606|NCT03566680|143150803|EQUIVALENCE|||||||0.08|||||||t-test, 2 sided|||||||0.08
71823607|NCT03566680|143150804|EQUIVALENCE|||||||0.72|||||||t-test, 2 sided|||||||0.72
71823608|NCT01492309|143150821|SUPERIORITY|||||||0.003|||||||Fisher Exact|||This analysis is based on a mixed model that can handle missing data.||||0.003
71823609|NCT01492309|143150822|SUPERIORITY|||||||0.425|||||||Regression, Logistic|||This analysis is based on a mixed model that can handle missing data.||||0.425
71823610|NCT02374957|143150825|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test)."||||0.26
71823611|NCT02374957|143150826|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test)."||||0.17
71823612|NCT02374957|143150827|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test)."||||0.027
71823613|NCT02374957|143150828|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test)."||||0.014
71823614|NCT02374957|143150829|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test)."||||0.82
71823615|NCT02374957|143150830|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test)."||||0.61
71823616|NCT02374957|143150831|SUPERIORITY|||||||0.26|||||||Log Rank|||"Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test)."||||0.26
71823617|NCT02334306|143150838|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.3||0.262|TWO_SIDED|90.0|-3.6|0.7|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||0.7|-3.6|0.262
71823618|NCT02334306|143150839|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.33||0.82|TWO_SIDED|90.0|0.52|1.64|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For plasma cell levels||1.64|0.52|0.820
71823619|NCT02334306|143150839|SUPERIORITY||Median Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.4||0.291|TWO_SIDED|90.0|0.33|1.28|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For TFH cells||1.28|0.33|0.291
71823620|NCT02334306|143150840|SUPERIORITY||Mean Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.17||0.44|TWO_SIDED|90.0|0.65|1.18|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For total plasma cells||1.18|0.65|0.440
71823621|NCT02334306|143150840|SUPERIORITY||Median Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.28||0.008|TWO_SIDED|90.0|0.26|0.7|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For CD4/ICOS TFH cells||0.70|0.26|0.008
71823622|NCT02334306|143150840|SUPERIORITY||Median Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|90.0|0.64|1.59|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For PD-1/ICOS TFH cells||1.59|0.64|0.972
71823623|NCT02334306|143150842|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.7||0.574|TWO_SIDED|90.0|-0.8|1.6|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.|||1.6|-0.8|0.574
71823624|NCT02334306|143150843|SUPERIORITY||Difference in percentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI \[3\]||50.9|-3.1|0.252
71823625|NCT02334306|143150843|SUPERIORITY||Difference in precentages|25.0||||0.252|TWO_SIDED|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI\[4\]||50.9|-3.1|0.252
71823626|NCT05349084|143150862|EQUIVALENCE|A Fisher's exact test was performed to determine the association between coronary artery stenosis and PET myocardial blood flow (MBF) values during stress. The following myocardial segments were analyzed: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). Coronary arteries were categorized as coronary arteries with a diameter stenosis ≥50% or \<50%. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as \>1.8 mL/g/min.||||||0.2522||||||The threshold for statistical significance was p = 0.05.|Fisher Exact|||||||0.2522
71823627|NCT05349084|143150863|OTHER|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028||||||The threshold for statistical significance was p = 0.05.|Pearson's correlation test|A Pearson's Correlation test was performed between PET MFR during stress and CT-FFR by territory.||||||0.028
71823628|NCT02987829|143150880|OTHER|||||||||||||||||Determination of the maximum tolerated dose.|One dose limiting toxicity occurred at 320 mg daily of grade 3 QTc prolongation therefore the 280 mg dose was determined to be the maximum tolerated dose and selected as the phase 2 dose.|||
71823629|NCT00647348|143150886|OTHER|intention-to-treat analysis||||||0.003|||||||BBSI=brain boundary shift integral|||||||0.003
71823630|NCT00647348|143150887|SUPERIORITY|||||||0.05||||||EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|ANCOVA|EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.||||||0.05
71823631|NCT02783950|143150898|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71823632|NCT02783950|143150899|SUPERIORITY|||||||0.7|||||||Wilcoxon Rank Test p-value|||||||0.70
71823633|NCT04319094|143150904|SUPERIORITY||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.77|-2.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = Post-intervention - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.62|-4.77|<0.0001
71643193|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.583|TWO_SIDED|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4||4.2|-7.6|0.583
71823634|NCT04319094|143150904|SUPERIORITY||Mean Difference (Net)|-2.53|STANDARD_ERROR_OF_MEAN|0.65||0.0001|TWO_SIDED|95.0|-3.81|-1.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 3-month - Baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.25|-3.81|0.0001
71823635|NCT04319094|143150904|SUPERIORITY||Median Difference (Net)|-2.83|STANDARD_ERROR_OF_MEAN|0.66|<|0.0001|TWO_SIDED|95.0|-4.13|-1.53||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 6-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.53|-4.13|<0.0001
71823636|NCT04319094|143150904|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.65|<|0.0001|TWO_SIDED|95.0|-4.03|-1.49||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference = 9-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.49|-4.03|<0.0001
71823637|NCT04319094|143150904|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_ERROR_OF_MEAN|0.71||0.0003|TWO_SIDED|95.0|-3.95|-1.17||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 501|Score difference =12-month - baseline|Null hypothesis: there is no difference in the mean Patient Health Questionnaire-9 (PHQ-9) scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-1.17|-3.95|0.0003
71823638|NCT04319094|143150904|SUPERIORITY|||||||0.4375|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of PHQ-9 over time between the control and PEERS participants.||||0.4375
71823639|NCT04319094|143150905|SUPERIORITY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|2.42||0.51|TWO_SIDED|95.0|-3.15|6.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36 - Physical Functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.37|-3.15|0.51
71823640|NCT04319094|143150905|SUPERIORITY||Mean Difference (Net)|4.57||||0.18|TWO_SIDED|95.0|-2.08|11.21||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.21|-2.08|0.18
71886161|NCT00662792|143292981|SUPERIORITY||Difference of adjusted means|-3.4|STANDARD_ERROR_OF_MEAN|2.6||0.1804|TWO_SIDED|95.0|-8.5|1.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||1.6|-8.5|0.1804
71886162|NCT00662792|143292982|SUPERIORITY||Difference of adjusted means|8.5|STANDARD_ERROR_OF_MEAN|2.5||0.0008|TWO_SIDED|95.0|3.5|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|3.5|0.0008
71886163|NCT00662792|143292982|SUPERIORITY||Difference of adjusted means|10.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|5.6|15.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||15.5|5.6|<.0001
71643194|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.028|TWO_SIDED|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4||22.5|1.8|0.028
71762628|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.94||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
71643195|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.087|TWO_SIDED|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4||18.3|-0.9|0.087
71762629|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.85||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y||||
71762630|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.03||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
71762631|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
71762632|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.007||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
71762633|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.04||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
71823641|NCT04319094|143150905|SUPERIORITY||Mean Difference (Net)|1.57|STANDARD_ERROR_OF_MEAN|3.29||0.63|TWO_SIDED|95.0|-4.89|8.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.04|-4.89|0.63
71823642|NCT04319094|143150905|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.01||0.74|TWO_SIDED|95.0|-6.94|4.91||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.91|-6.94|0.74
71823643|NCT04319094|143150905|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.83||0.85|TWO_SIDED|95.0|-6.82|8.23||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 364||Null hypothesis: there is no difference in the mean SF36-physical function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|8.23|-6.82|0.85
71823644|NCT04319094|143150905|SUPERIORITY|||||||0.3988|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of physical functioning over time between the control and PEERS participants.||||0.3988
71823645|NCT04319094|143150906|SUPERIORITY||Mean Difference (Net)|5.08|STANDARD_ERROR_OF_MEAN|3.41||0.14|TWO_SIDED|95.0|-1.63|11.79||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|11.79|-1.63|0.14
71823646|NCT04319094|143150906|SUPERIORITY||Mean Difference (Net)|10.32|STANDARD_ERROR_OF_MEAN|4.0||0.01|TWO_SIDED|95.0|2.45|18.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.19|2.45|0.01
71886164|NCT00662792|143292982|SUPERIORITY||Difference of adjusted means|-12.9|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-17.9|-8.0|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-8.0|-17.9|<.0001
71886165|NCT00662792|143292983|SUPERIORITY||Difference of adjusted means|10.1|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|5.7|14.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||14.6|5.7|<.0001
71643196|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.632|TWO_SIDED|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8||9.4|-5.6|0.632
71762634|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
71823647|NCT04319094|143150906|SUPERIORITY||Mean Difference (Net)|10.25|STANDARD_ERROR_OF_MEAN|4.19||0.015|TWO_SIDED|95.0|2.01|18.5||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|18.5|2.01|0.015
71823648|NCT04319094|143150906|SUPERIORITY||Mean Difference (Net)|11.72|STANDARD_ERROR_OF_MEAN|4.07||0.004|TWO_SIDED|95.0|3.7|19.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|19.73|3.7|0.004
71823649|NCT04319094|143150906|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|4.49||0.2|TWO_SIDED|95.0|-3.09|14.55||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 360||Null hypothesis: there is no difference in the mean SF36-social function scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|14.55|-3.09|0.2
71823650|NCT04319094|143150906|SUPERIORITY|||||||0.8037|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of social functioning over time between the control and PEERS participants.||||0.8037
71823651|NCT04319094|143150907|SUPERIORITY||Median Difference (Net)|12.52|STANDARD_ERROR_OF_MEAN|5.01||0.0129|TWO_SIDED|95.0|2.67|22.37||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|22.37|2.67|0.0129
71823652|NCT04319094|143150907|SUPERIORITY||Mean Difference (Net)|19.84|STANDARD_ERROR_OF_MEAN|5.86||0.0008|TWO_SIDED|95.0|8.32|31.36||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|31.36|8.32|0.0008
71823653|NCT04319094|143150907|SUPERIORITY||Median Difference (Net)|17.99|STANDARD_ERROR_OF_MEAN|6.14||0.0036|TWO_SIDED|95.0|5.92|30.06||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|30.06|5.92|0.0036
71823654|NCT04319094|143150907|SUPERIORITY||Median Difference (Net)|16.24|STANDARD_ERROR_OF_MEAN|5.98||0.007|TWO_SIDED|95.0|4.47|28.01||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|28.01|4.47|0.007
71886166|NCT00662792|143292983|SUPERIORITY||Difference of adjusted means|17.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|12.9|21.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||21.9|12.9|<.0001
71886167|NCT00662792|143292983|SUPERIORITY||Difference of adjusted means|-8.2|STANDARD_ERROR_OF_MEAN|2.3||0.0004|TWO_SIDED|95.0|-12.7|-3.7|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S\_DPI)|||-3.7|-12.7|0.0004
71886168|NCT00662792|143292984|SUPERIORITY||Difference of adjusted means|13.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|7.2|18.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||18.9|7.2|<.0001
71702364|NCT02034591|142921738|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.813|||||TWO_SIDED|90.0|0.766|0.863||||||||0.863|0.766|
71702365|NCT02034591|142921739|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.81|||||TWO_SIDED|90.0|0.764|0.86||||||||0.860|0.764|
71702366|NCT02034591|142921740|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.884|||||TWO_SIDED|90.0|0.83|0.942||||||||0.942|0.830|
71702367|NCT02034591|142921741|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.95|||||TWO_SIDED|90.0|0.905|0.997||||||||0.997|0.905|
71702368|NCT02034591|142921742|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.947|||||TWO_SIDED|90.0|0.903|0.994||||||||0.994|0.903|
71702369|NCT01121926|142921750|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax,ss is between 80% and 125%.|Mean ratio|56.53|||||TWO_SIDED|90.0|49.99|63.94|||||Test/reference (%)|||63.94|49.99|
71823655|NCT04319094|143150907|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|6.58||0.065|TWO_SIDED|95.0|-0.68|25.19||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 366||Null hypothesis: there is no difference in the mean SF36-emotional functioning scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|25.19|-0.68|0.065
71823656|NCT04319094|143150907|SUPERIORITY|||||||0.881|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of emotional functioning over time between the control and PEERS participants.||||0.8810
71823657|NCT04319094|143150908|SUPERIORITY|||||||0.031||||||The a priori threshold for statistical significance is p=0.05.|F-test for overall significance|Degrees of freedom: 370||Null hypothesis: there is no difference in the change in probability of ER use from baseline to post-intervention between PEERS and control participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|||0.031
71823658|NCT04319094|143150913|SUPERIORITY||Mean Difference (Net)|-4.98|STANDARD_ERROR_OF_MEAN|1.42||0.0005|TWO_SIDED|95.0|-7.78|-2.18||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-2.18|-7.78|0.0005
71823659|NCT04319094|143150913|SUPERIORITY||Mean Difference (Net)|-7.38|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.08|-3.69||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.69|-11.08|<0.0001
71823660|NCT04319094|143150913|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-11.3|-3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-3.95|-11.3|<0.0001
71823661|NCT04319094|143150913|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-11.53|-4.7||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.7|-11.53|<0.0001
71823662|NCT04319094|143150913|SUPERIORITY||Mean Difference (Net)|-8.26|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-12.37|-4.14||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 414|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean UCLA Loneliness scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|-4.14|-12.37|<0.0001
71643197|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.016|TWO_SIDED|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8||24.8|3.1|0.016
71762635|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
71643198|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|15.8||||0.009|TWO_SIDED|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8||27.0|4.5|0.009
71762636|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.13||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71762637|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.28||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71762638|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
71762639|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.1||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A||||
71762640|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.11||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
71762641|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.06||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C||||
71762642|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
71762643|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135||||
71762644|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.39||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71762645|NCT00488683|143027042|SUPERIORITY_OR_OTHER||R-square|0.33||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y||||
71762646|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.24||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
71762647|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
71762648|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.52||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
71762649|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
71762650|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
71762651|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.29||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
71762652|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
71762653|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.05||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
71762654|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.7||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
71762655|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A||||
71762656|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.5||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
71762657|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.16||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C||||
71643199|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.974|TWO_SIDED|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12||11.6|-11.2|0.974
71643200|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.031|TWO_SIDED|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12||29.3|1.8|0.031
71643201|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|15.6||||0.032|TWO_SIDED|95.0|1.8|29.5|||Cochran-Mantel-Haenszel|||Week 12||29.5|1.8|0.032
71643202|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.553|TWO_SIDED|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16||16.9|-9.0|0.553
71643203|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.008|TWO_SIDED|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16||35.8|6.1|0.008
71643204|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|13.9||||0.061|TWO_SIDED|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16||28.2|-0.3|0.061
71643205|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.585|TWO_SIDED|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20||18.0|-10.1|0.585
71643206|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.032|TWO_SIDED|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20||32.8|2.0|0.032
71643207|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|8.6||||0.254|TWO_SIDED|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20||23.1|-5.9|0.254
71643208|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.598|TWO_SIDED|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||Week 24||19.8|-11.3|0.598
71643209|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.066|TWO_SIDED|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||Week 24||31.4|-0.4|0.066
71643210|NCT03100344|142804684|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.826|TWO_SIDED|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||Week 24||16.9|-13.5|0.826
71643211|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-10.0||||0.049|TWO_SIDED|95.0|-20.0|0.0|||Kenward-Rogers|||Week 1||0.0|-20.0|0.049
71643212|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-16.9|||<|0.001|TWO_SIDED|95.0|-26.7|-7.0|||Kenward Roger|||Week 1||-7.0|-26.7|<0.001
71762658|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|1.0||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
71762659|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.3||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135||||
71762660|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.21||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
71643213|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-15.7||||0.002|TWO_SIDED|95.0|-25.6|-5.8|||Kenward Roger|||Week 1||-5.8|-25.6|0.002
71762661|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.12||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y||||
71643214|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-9.8||||0.084|TWO_SIDED|95.0|-20.9|1.3|||Kenward Roger|||Week 2||1.3|-20.9|0.084
71643215|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-16.2||||0.004|TWO_SIDED|95.0|-27.2|-5.2|||Kenward Roger|||Week 2||-5.2|-27.2|0.004
71643216|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-14.8||||0.008|TWO_SIDED|95.0|-25.8|-3.8|||Kenward Roger|||Week 2||-3.8|-25.8|0.008
71643217|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-14.0||||0.044|TWO_SIDED|95.0|-27.5|-0.4|||Kenward Roger|||Week 4||-0.4|-27.5|0.044
71643218|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-21.1||||0.002|TWO_SIDED|95.0|-34.7|-7.6|||Kenward Roger|||Week 4||-7.6|-34.7|0.002
71643219|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-15.3||||0.026|TWO_SIDED|95.0|-28.8|-1.8|||Kenward Roger|||Week 4||-1.8|-28.8|0.026
71643220|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-14.8||||0.062|TWO_SIDED|95.0|-30.2|0.7|||Kenward Roger|||Week 8||0.7|-30.2|0.062
71643221|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-23.4||||0.003|TWO_SIDED|95.0|-38.9|-7.9|||Kenward Roger|||Week 8||-7.9|-38.9|0.003
71643222|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-20.6||||0.009|TWO_SIDED|95.0|-36.0|-5.2|||Kenward Roger|||Week 8||-5.2|-36.0|0.009
71643223|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-15.9||||0.022|TWO_SIDED|95.0|-29.4|-2.3|||Kenward Roger|||Week 12||-2.3|-29.4|0.022
71643224|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-23.7|||<|0.001|TWO_SIDED|95.0|-37.1|-10.2|||Kenward Roger|||Week 12||-10.2|-37.1|<0.001
71643225|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-14.7||||0.032|TWO_SIDED|95.0|-28.1|-1.3|||Kenward Roger|||Week 12||-1.3|-28.1|0.032
71643226|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-13.7||||0.07|TWO_SIDED|95.0|-28.6|1.1|||Kenward Roger|||Week 16||1.1|-28.6|0.070
71643227|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-23.7||||0.002|TWO_SIDED|95.0|-38.5|-8.9|||Kenward Roger|||Week 16||-8.9|-38.5|0.002
71643228|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-10.7||||0.154|TWO_SIDED|95.0|-25.6|4.1|||Kenward Roger|||Week 16||4.1|-25.6|0.154
71643229|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-12.1||||0.09|TWO_SIDED|95.0|-26.0|1.9|||Kenward Roger|||Week 20||1.9|-26.0|0.090
71643230|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-15.9||||0.024|TWO_SIDED|95.0|-29.7|-2.1|||Kenward Roger|||Week 20||-2.1|-29.7|0.024
71643231|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-9.5||||0.18|TWO_SIDED|95.0|-23.4|4.4|||Kenward Roger|||Week 20||4.4|-23.4|0.180
71643232|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-13.6||||0.051|TWO_SIDED|95.0|-27.3|0.0|||Kenward Roger|||Week 24||0.0|-27.3|0.051
71643233|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-16.7||||0.016|TWO_SIDED|95.0|-30.2|-3.2|||Kenward Roger|||Week 24||-3.2|-30.2|0.016
71643234|NCT03100344|142804685|SUPERIORITY||mean difference of percentage changes|-6.8||||0.322|TWO_SIDED|95.0|-20.5|6.8|||Kenward Roger|||Week 24||6.8|-20.5|0.322
71643235|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-10.9||||0.012|TWO_SIDED|95.0|-19.4|-2.4|||Kenward Roger|||Week 1||-2.4|-19.4|0.012
71643236|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-15.4|||<|0.001|TWO_SIDED|95.0|-23.8|-7.1|||Kenward Roger|||Week 1||-7.1|-23.8|<0.001
71643237|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-9.4||||0.029|TWO_SIDED|95.0|-17.8|-0.9|||Kenward Roger|||Week 1||-0.9|-17.8|0.029
71643238|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-21.8|||<|0.001|TWO_SIDED|95.0|-32.0|-11.6|||Kenward Roger|||Week 2||-11.6|-32.0|<0.001
71643239|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-29.1|||<|0.001|TWO_SIDED|95.0|-39.1|-19.1|||Kenward Roger|||Week 2||-19.1|-39.1|<0.001
71643240|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-34.0|-13.6|||Kenward Roger|||Week 2||-13.6|-34.0|<0.001
71643241|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-21.3|||<|0.001|TWO_SIDED|95.0|-32.1|-10.5|||Kenward Roger|||Week 4||-10.5|-32.1|<0.001
71643242|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-34.8|||<|0.001|TWO_SIDED|95.0|-45.5|-24.2|||Kenward Roger|||Week 4||-24.2|-45.5|<0.001
71643243|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-30.7|||<|0.001|TWO_SIDED|95.0|-41.6|-19.9|||Kenward Roger|||Week 4||-19.9|-41.6|<0.001
71643244|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-22.9|||<|0.001|TWO_SIDED|95.0|-33.2|-12.6|||Kenward Roger|||Week 8||-12.6|-33.2|<0.001
71643245|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-37.3|||<|0.001|TWO_SIDED|95.0|-47.4|-27.2|||Kenward Roger|||Week 8||-27.2|-47.4|<0.001
71643246|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-34.1|||<|0.001|TWO_SIDED|95.0|-44.4|-23.8|||Kenward Roger|||Week 8||-23.8|-44.4|<0.001
71762662|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.0015||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
71762663|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.0057||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
71762664|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
71762665|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.02||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
71643247|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-24.1|||<|0.001|TWO_SIDED|95.0|-35.6|-12.5|||Kenward Roger|||Week 12||-12.5|-35.6|<0.001
71643248|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-38.4|||<|0.001|TWO_SIDED|95.0|-49.7|-27.2|||Kenward Roger|||Week 12||-27.2|-49.7|<0.001
71643249|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-30.2|||<|0.001|TWO_SIDED|95.0|-41.7|-18.7|||Kenward Roger|||Week 12||-18.7|-41.7|<0.001
71643250|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-20.9|||<|0.001|TWO_SIDED|95.0|-32.8|-8.9|||Kenward Roger|||Week 16||-8.9|-32.8|<0.001
71643251|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-34.3|||<|0.001|TWO_SIDED|95.0|-46.0|-22.6|||Kenward Roger|||Week 16||-22.6|-46.0|<0.001
71643252|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-28.7|||<|0.001|TWO_SIDED|95.0|-40.7|-16.8|||Kenward Roger|||Week 16||-16.8|-40.7|<0.001
71643253|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-21.1||||0.001|TWO_SIDED|95.0|-33.7|-8.4|||Kenward Roger|||Week 20||-8.4|-33.7|0.001
71643254|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-29.7|||<|0.001|TWO_SIDED|95.0|-42.1|-17.3|||Kenward Roger|||Week 20||-17.3|-42.1|<0.001
71643255|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-27.9|||<|0.001|TWO_SIDED|95.0|-40.6|-15.2|||Kenward Roger|||Week 20||-15.2|-40.6|<0.001
71643256|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-22.4||||0.002|TWO_SIDED|95.0|-36.1|-8.6|||Kenward Roger|||Week 24||-8.6|-36.1|0.002
71643257|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-31.5|||<|0.001|TWO_SIDED|95.0|-44.9|-18.0|||Kenward Roger|||Week 24||-18.0|-44.9|<0.001
71643258|NCT03100344|142804686|SUPERIORITY||mean difference of percentage changes|-30.0|||<|0.001|TWO_SIDED|95.0|-43.8|-16.2|||Kenward Roger|||Week 24||-16.2|-43.8|<0.001
71643259|NCT03100344|142804688|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-3.0|-1.0|||Kenward Roger|||Week 24||-1.0|-3.0|<0.001
71643260|NCT03100344|142804688|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.001|TWO_SIDED|95.0|-3.8|-1.8|||Kenward Roger|||Week 24||-1.8|-3.8|<0.001
71643261|NCT03100344|142804688|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.3|-1.3|||Kenward Roger|||Week 24||-1.3|-3.3|<0.001
71643262|NCT03100344|142804689|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||Kenward Roger|||Week 24||-0.9|-3.0|<0.001
71643263|NCT03100344|142804689|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.6|-1.6|||Kenward Roger|||Week 24||-1.6|-3.6|<0.001
71643264|NCT03100344|142804689|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||Kenward Roger|||Week 24||-1.1|-3.1|<0.001
71643265|NCT03100344|142804690|SUPERIORITY||mean difference of percentage changes|-23.8|||<|0.001|TWO_SIDED|95.0|-37.7|-9.9|||Kenward Roger|||Week 24||-9.9|-37.7|<0.001
71762666|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.0048||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
71643266|NCT03100344|142804690|SUPERIORITY||mean difference of percentage changes|-31.4|||<|0.001|TWO_SIDED|95.0|-45.0|-17.7|||Kenward Roger|||Week 24||-17.7|-45.0|<0.001
71643267|NCT03100344|142804690|SUPERIORITY||mean difference of percentage changes|-29.2|||<|0.001|TWO_SIDED|95.0|-43.2|-15.2|||Kenward Roger|||Week 24||-15.2|-43.2|<0.001
71643268|NCT04633564|142804706|EQUIVALENCE|The equivalence region is (0.73, 1.36).|Risk Ratio (RR)|0.96|||||TWO_SIDED|90.0|0.83|1.12||||||||1.12|0.83|
71643269|NCT01935674|142804707|SUPERIORITY||Mean Difference (Net)|12.7||||0.003|TWO_SIDED|95.0|2.9|22.5||P-value from Wilcoxon rank-sum test; significance threshold set at α = 0.05. No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|Two-sided test; analysis based on intention-to-treat population.||Comparison of percentage change in fasting total cholesterol from baseline to week 12 between rosuvastatin and PI/r switch groups. Wilcoxon rank-sum test used. Study powered to detect a 15% difference with 80% power and α = 0.05. All participants included in intention-to-treat analysis.||22.5|2.9|0.003
71643270|NCT02433977|142804715|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643271|NCT02433977|142804716|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643272|NCT02433977|142804717|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643273|NCT02433977|142804718|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643274|NCT02433977|142804720|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643275|NCT02433977|142804722|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643276|NCT02433977|142804723|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643277|NCT02433977|142804724|OTHER||||||<=|0.05|||||||t-test, 1 sided|||||||<=0.05
71643278|NCT02222818|142804734|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025.|Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ -2% Alternative Hypothesis (Ha): μd \> -2% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods, and -2% is the non-inferiority margin selected based upon clinical judgment.||9.5|4.5|<0.0001
71643279|NCT02222818|142804735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ 0% Alternative Hypothesis (Ha): μd \> 0% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects' paired measurements from the two cross-over follow-up periods.||9.5|4.5|<0.0001
71643280|NCT00834717|142804736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.86||||||90.0|92.36|103.69|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.69|92.36|
71643281|NCT00834717|142804737|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.57||||||90.0|82.8|103.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.48|82.80|
71643282|NCT00834717|142804738|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.95||||||90.0|83.11|103.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.97|83.11|
71643283|NCT00238615|142804825|SUPERIORITY_OR_OTHER||probability of survival at 2 years|0.72|STANDARD_DEVIATION|0.0|||TWO_SIDED|95.0|0.36|0.9||The primary endpoint of 2 year overall survival was (0.72) = 72%||||2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.||0.90|0.36|
71643284|NCT05710718|142804826|SUPERIORITY|||||||0.076|||||||paired T-test|No formal hypothesis test was planned for this pilot study. P-values are provided for exploratory purposes and are unadjusted for multiplicity.||||||0.076
71643285|NCT00836004|142804839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|99.69||||||90.0|93.88|105.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.85|93.88|
71643286|NCT00836004|142804840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.62|102.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.19|90.62|
71643287|NCT00836004|142804841|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.17||||||90.0|92.14|102.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.48|92.14|
71643288|NCT00859521|142804845|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.7||||||90.0|92.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|92.4|
71643289|NCT00859521|142804846|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|96.9|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|96.9|
71643290|NCT00859521|142804847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.8||||||90.0|97.2|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|97.2|
71762667|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.0018||||||95.0|||||Regression, Linear||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
71643291|NCT03552484|142804875|SUPERIORITY||Median Difference (Final Values)|0.05||||0.59|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Within-group paired t-tests and between-group paired t-tests||||0.59
71643292|NCT03552484|142804876|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.59|TWO_SIDED|95.0||||Between-group comparison|t-test, 2 sided|||||||0.59
71643293|NCT03552484|142804877|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.62|TWO_SIDED|||||Between-group comparison of change in Multidimensional Caregiver Strain Index|t-test, 2 sided|||||||0.62
71643294|NCT02663349|142804893|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|df = 14||Within sample analysis of change between baseline and 3 month assessment.||||.08
71643295|NCT02663349|142804894|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Within sample change between baseline and 6 month assessment.||||.69
71643296|NCT02663349|142804895|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|df=14||Within sample change assessed between baseline and 3-month assessment||||.02
71643297|NCT02663349|142804896|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|df = 14||Change between baseline and 6 month assessment||||.34
71643298|NCT02663349|142804897|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of change between baseline and 3-month assessment on the AIHQ Hostility scale||||>.05
71643299|NCT02663349|142804897|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Completer analysis to examine within group change between baseline and 3-month assessment on the AIHQ Aggression scale||||.04
71643300|NCT02663349|142804898|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Hostility scale between baseline and the 6-month assessment||||>.05
71643301|NCT02663349|142804898|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||completer analysis of within group change on the AIHQ Aggression scale between baseline and the 6 month assessment||||> .05
71643302|NCT02663349|142804899|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Change within group between baseline and 3 month assessment on the TASIT total score for part 3||||> .05
71643303|NCT02663349|142804900|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||within group change on the TASIT total score for Part 3 between baseline and the 6 month assessment||||> .05
71643304|NCT02663349|142804901|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on SSPA Total Score between baseline and 3-month assessment||||>.05
71643305|NCT02663349|142804902|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 14||Within group change on the SSPA total score between baseline and 6 month assessment||||> .05
71643306|NCT02663349|142804903|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change on the First Episode Social Functioning Scale Performance Total score on scales 1-7 between baseline and 3-month follow-up||||> .05
71643307|NCT02663349|142804904|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 15||Within group change between baseline and 6-month assessment on the First Episode Social Functioning Scale Performance total score on scales 1-7||||> .05
71643308|NCT02663349|142804905|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between Baseline and 3-Month assessments||||.15
71643309|NCT02663349|142804905|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 3-month assessments||||.10
71643310|NCT02663349|142804905|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 3-month assessment||||>.05
71643311|NCT02663349|142804905|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 3 month assessment||||> .05
71643312|NCT02663349|142804906|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Collegial Support scale between baseline and the 6-month assessment||||.01
71643313|NCT02663349|142804906|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Task Support scale between baseline and 6-month assessment||||.03
71643314|NCT02663349|142804906|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Mentor scale between baseline and the 6-month assessment||||> .05
71643315|NCT02663349|142804906|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on the MCSS Coach scale between baseline and the 6-month assessment||||> .05
71643316|NCT02663349|142804907|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Self Disclosure scale between Baseline and 3-Month Assessment||||.09
71643317|NCT02663349|142804907|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|df = 13||Within group change on the VETSS Workplace Coping scale between Baseline and 3-Month Assessment||||.12
71643318|NCT02663349|142804908|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Self Disclosure scale between Baseline and 6 month assessment||||> .05
71643319|NCT02663349|142804908|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|df = 13||Within group change on VETSS Workplace Coping scale between baseline and the 6 month assessment||||> .05
71643320|NCT00673660|142804933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Total cholesterol||||<0.001
71643321|NCT00673660|142804933|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||LDL cholesterol||||<0.001
71643322|NCT00673660|142804933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 1 sided|||HDL cholesterol||||0.972
71643323|NCT00673660|142804933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED|||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Triglycerides||||0.034
71643324|NCT05099380|142804954|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-0.6|6.7|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a two independent sample t test with a 2-sided type I error of 0.05, there would be enough power (i.e., 80%) for testing non-inferiority of the Test relative to the Control with 286 subjects (143 for each lens group) competing the study assuming the Test was 2 points higher than the Control.||6.7|-0.6|
71660929|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 3||||0.006
71823663|NCT04319094|143150913|SUPERIORITY|||||||0.6857|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change of UCLA Loneliness score over time between control and PEERS participants||||0.6857
71643325|NCT05099380|142804955|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.05.|Least-square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.02|0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculation using a linear mixed model-based method with a 2-sided type I error of 0.05, there would be enough power (i.e., at least 80%) for testing non-inferiority of the Test relative to the Control with 16 subjects (8 for each lens group) competing the study assuming no difference between the Test and the Control.||0.01|-0.02|
71643326|NCT05099380|142804956|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.05.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 240 subjects (120 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
71643327|NCT05099380|142804957|NON_INFERIORITY|Non- inferiority was declared if the upper bound of the 95% central posterior credible interval of proportion difference was below 0.1.|Mean Proportion Difference|0.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|-0.004|0.004|||Bayesian hierarchical model||Proportion difference was calculated as Test minus Control|Based on the sample size calculation using a simulation approach and Bayesian analysis with the 95% central posterior credible interval, there would be enough power (i.e., at least 80%) for assessing non-inferiority of the Test relative to the Control with 140 subjects (70 for each lens group) competing the study assuming no difference between the Test and the Control.||0.004|-0.004|
71643328|NCT05099380|142804958|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-4.8|4.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 73% for CLUE comfort using a two independent sample t test with a 2-sided type I error of 0.05.||4.5|-4.8|
71643329|NCT05099380|142804959|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5.|Least-square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-6.0|2.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the Test was 2 points lower than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 23% for CLUE handling using a two independent sample t test with a 2-sided type I error of 0.05.||2.3|-6.0|
71643330|NCT05099380|142804960|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the odds ratio was greater than 0.67.|Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.83|2.16|||Linear Mixed Model||Odds Ratio was calculated as Test over Control|"Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of Excellent rating for the Test was 10% higher than the Control, the estimated statistical power for testing non-inferiority of the Test relative to the Control was 93% using a Pearson chi-square test for two proportions with a 2-sided type I error of 0.05."||2.16|0.83|
71643331|NCT05099380|142804961|SUPERIORITY|Superiority was declared if the lower bound of the 2-sided 95% confidence interval of the preference ratio was greater than 1.|Preference Ratio|2.4|||||TWO_SIDED|95.0|1.4|4.1|||Linear Mixed Model||Preference ratio was calculated as Study lens over Habitual lens within the Test lens group.|Based on the sample size calculated for the primary endpoints (i.e., 286 subjects with 143 per lens group), assuming the percentage of subjects preferring Study lens was 20% higher than preferring Habitual lens in the Test lens group, the estimated statistical power for testing superiority of the Test relative to the Habitual was 88% using a simulation approach with a 2-sided type I error of 0.05.||4.10|1.40|
71643332|NCT02558491|142804978|OTHER|||||||0.045||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.045
71643333|NCT02558491|142804978|OTHER|||||||0.07||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.07
71660930|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.519||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.519
71762668|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.01||||||95.0|||||Regression, Linear|||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
71762669|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.0||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
71643334|NCT02558491|142804978|OTHER|||||||0.177||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Primary statistical analysis was performed using the repeated measure ANOVA, with the treatment mode as within subject factor, and type of insulin treatment (pump vs. MDI) as between subject factor. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.177
71643335|NCT02558491|142804979|OTHER|||||||0.042||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test was used. Data were first binned (to ensure minimum count of five per bins) \& w2 statistics was used with expected counts given by standard of care. Based on achieved recruitment, moderate effect size (0.3) was detectable with 80% power, or large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.042
71643336|NCT02558491|142804979|OTHER|||||||0.276||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.276
71643337|NCT02558491|142804980|OTHER|||||||0.026||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.026
71643338|NCT02558491|142804980|OTHER|||||||0.173||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.173
71643339|NCT02558491|142804980|OTHER|||||||0.715||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.715
71643340|NCT02558491|142804981|OTHER|||||||0.036||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.036
71643341|NCT02558491|142804981|OTHER|||||||0.213||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.213
71643342|NCT02558491|142804981|OTHER|||||||0.11||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.110
71643343|NCT02558491|142804982|OTHER|||||||0.018||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.018
71643344|NCT02558491|142804982|OTHER|||||||0.149||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.149
71762670|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.27||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
71643345|NCT02558491|142804982|OTHER|||||||0.109||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.109
71643346|NCT02558491|142804983|OTHER|||||||0.78||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.78
71643347|NCT02558491|142804983|OTHER|||||||0.399||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.399
71660931|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.226||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.226
71762671|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.19||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A||||
71643348|NCT02558491|142804983|OTHER|||||||0.824||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.824
71643349|NCT02558491|142804984|OTHER|||||||0.863||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.863
71643350|NCT02558491|142804984|OTHER|||||||0.965||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.965
71643351|NCT02558491|142804984|OTHER|||||||0.742||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.742
71643352|NCT02558491|142804985|OTHER|||||||0.158||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.158
71643353|NCT02558491|142804985|OTHER|||||||0.085||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.085
71643354|NCT02558491|142804985|OTHER|||||||0.055||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.055
71643355|NCT02558491|142804986|OTHER|||||||0.744||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.744
71643356|NCT02558491|142804986|OTHER|||||||0.248||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.248
71643357|NCT02558491|142804986|OTHER|||||||0.225||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|Wilcoxon (Mann-Whitney)|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.225
71762672|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
71643358|NCT02558491|142804987|OTHER|||||||0.86||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.86
71643359|NCT02558491|142804987|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for mealtime.||||0.522
71643360|NCT02558491|142804987|OTHER|||||||0.522||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overnight.||||0.522
71643361|NCT02558491|142804988|OTHER|||||||0.301||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.301
71643362|NCT02558491|142804989|OTHER|||||||0.189||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.189
71643363|NCT02558491|142804990|OTHER|||||||0.271||||||No a priori sample size was determined due to the feasibility/pilot nature of the trial. Significance level was set at P-value \<0.05.|ANOVA|||Secondary analysis followed the same format unless variables could not be considered normally distributed; in that case a related samples Wilcoxon signed-rank test is used. Data were first binned (to ensure minimum count of five per bins) and the w2 statistics was used with the expected counts given by SoC. Based on achieved recruitment, a moderate effect size (0.3) is detectable with 80% power, or a large effect size (0.4) with 95% power (G-Power 3.1.9.2). Outcome measurement was for overall.||||0.271
71643364|NCT00834431|142804993|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.0||||||90.0|85.9|98.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.6|85.9|
71643365|NCT00834431|142804994|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.2|
71643366|NCT00834431|142804995|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.7||||||90.0|96.3|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101|96.3|
71643367|NCT01020474|142805028|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.121|TWO_SIDED|95.0|-1.51|0.18||Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.|ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.18|-1.51|0.121
71643368|NCT01020474|142805029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18||||0.655|TWO_SIDED|95.0|-1.0|0.63|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||0.63|-1.00|0.655
71643369|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07||||0.842|TWO_SIDED|95.0|-0.75|0.61|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.61|-0.75|0.842
71762673|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.08||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C||||
71643370|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.07|TWO_SIDED|95.0|-1.32|0.05|||Mixed Models Analysis|||Statistical analysis of Week 2||0.05|-1.32|0.070
71643371|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.019|TWO_SIDED|95.0|-1.51|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 3.||-0.14|-1.51|0.019
71643372|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.011|TWO_SIDED|95.0|-1.59|-0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||-0.21|-1.59|0.011
71643373|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.056|TWO_SIDED|95.0|-1.38|0.02|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.02|-1.38|0.056
71643374|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.008|TWO_SIDED|95.0|-1.66|-0.26|||Mixed Models Analysis|||Statistical analysis of Week 6.||-0.26|-1.66|0.008
71643375|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.89||||0.013|TWO_SIDED|95.0|-1.6|-0.19|||Mixed Models Analysis|||Statistical analysis of Week 7.||-0.19|-1.60|0.013
71643376|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06||||0.004|TWO_SIDED|95.0|-1.77|-0.35|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.35|-1.77|0.004
71643377|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.95||||0.009|TWO_SIDED|95.0|-1.67|-0.24|||Mixed Models Analysis|||Statistical analysis of Week 9.||-0.24|-1.67|0.009
71643378|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.008|TWO_SIDED|95.0|-1.69|-0.25|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.25|-1.69|0.008
71643379|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.021|TWO_SIDED|95.0|-1.59|-0.13|||Mixed Models Analysis|||Statistical analysis of Week 11.||-0.13|-1.59|0.021
71643380|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97||||0.01|TWO_SIDED|95.0|-1.71|-0.23|||Mixed Models Analysis|||Statistical analysis of Week 12.||-0.23|-1.71|0.010
71643381|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.49|0.0|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.00|-1.49|0.051
71886169|NCT00662792|143292984|SUPERIORITY||Difference of adjusted means|23.1|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|17.2|28.9|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||28.9|17.2|<.0001
71643382|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.02|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 14.||-0.14|-1.66|0.020
71643383|NCT01020474|142805030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.06|TWO_SIDED|95.0|-1.51|0.03|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.03|-1.51|0.060
71886170|NCT00662792|143292984|SUPERIORITY||Difference in adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|3.0||0.0769|TWO_SIDED|95.0|-11.2|0.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.6|-11.2|0.0769
71643384|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.54|TWO_SIDED|95.0|-0.9|0.47|||Mixed Models Analysis|||Statistical analysis of Week 1.||0.47|-0.90|0.540
71643385|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.593|TWO_SIDED|95.0|-0.87|0.5|||Mixed Models Analysis|||Statistical analysis of Week 2||0.50|-0.87|0.593
71643386|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.206|TWO_SIDED|95.0|-1.13|0.25|||Mixed Models Analysis|||Statistical analysis of Week 3.||0.25|-1.13|0.206
71643387|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||0.168|TWO_SIDED|95.0|-1.18|0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.||0.21|-1.18|0.168
71643388|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38||||0.28|TWO_SIDED|95.0|-1.08|0.32|||Mixed Models Analysis|||Statistical analysis of Week 5.||0.32|-1.08|0.280
71643389|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.075|TWO_SIDED|95.0|-1.34|0.06|||Mixed Models Analysis|||Statistical analysis of Week 6.||0.06|-1.34|0.075
71643390|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.168|TWO_SIDED|95.0|-1.21|0.21|||Mixed Models Analysis|||Statistical analysis of Week 7.||0.21|-1.21|0.168
71643391|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01||||0.006|TWO_SIDED|95.0|-1.73|-0.3|||Mixed Models Analysis|||Statistical analysis of Week 8.||-0.30|-1.73|0.006
71643392|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.57||||0.12|TWO_SIDED|95.0|-1.29|0.15|||Mixed Models Analysis|||Statistical analysis of Week 9.||0.15|-1.29|0.120
71643393|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.037|TWO_SIDED|95.0|-1.49|-0.05|||Mixed Models Analysis|||Statistical analysis of Week 10.||-0.05|-1.49|0.037
71643394|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.3|||Mixed Models Analysis|||Statistical analysis of Week 11.||0.30|-1.16|0.246
71643395|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.105|TWO_SIDED|95.0|-1.36|0.13|||Mixed Models Analysis|||Statistical analysis of Week 12.||0.13|-1.36|0.105
71643396|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.376|TWO_SIDED|95.0|-1.09|0.41|||Mixed Models Analysis|||Statistical analysis of Week 13.||0.41|-1.09|0.376
71643397|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.285|TWO_SIDED|95.0|-1.18|0.35|||Mixed Models Analysis|||Statistical analysis of Week 14.||0.35|-1.18|0.285
71643398|NCT01020474|142805031|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17||||0.663|TWO_SIDED|95.0|-0.95|0.61|||Mixed Models Analysis|||Statistical analysis of Week 15.||0.61|-0.95|0.663
71643399|NCT01020474|142805032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.037|TWO_SIDED|95.0|-1.68|-0.05|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).||||-0.05|-1.68|0.037
71643400|NCT01020474|142805033|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.694|TWO_SIDED|95.0|0.53|2.58|||Regression, Logistic|||Statistical analysis at Week 15.||2.58|0.53|0.694
71643401|NCT01020474|142805034|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.162|TWO_SIDED|95.0|0.72|7.02|||Regression, Logistic|||Statistical analysis at Week 15.||7.02|0.72|0.162
71643402|NCT01020474|142805035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Cochran-Mantel-Haenszel|P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.||Statistical analysis at Week 15.||||0.013
71643403|NCT00835146|142805036|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.9||||||90.0|91.8|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|91.8|
71643404|NCT00835146|142805037|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|93.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|93.3|
71643405|NCT00466167|142805045|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|4.9|STANDARD_ERROR_OF_MEAN|1.3||0.0001|TWO_SIDED|95.0|2.4|7.4|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.4|2.4|0.0001
71643406|NCT00466167|142805045|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|6.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|4.2|9.1|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||9.1|4.2|<.0001
71643407|NCT00466167|142805046|SUPERIORITY_OR_OTHER||Adjusted mean difference from Placebo|4.5|STANDARD_ERROR_OF_MEAN|1.8||0.0122|TWO_SIDED|95.0|1.0|7.9|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||7.9|1.0|0.0122
71643408|NCT00466167|142805046|SUPERIORITY_OR_OTHER||Adjusted mean difference from placebo|7.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|3.7|10.5|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline||10.5|3.7|<.0001
71643409|NCT02927639|142805067|SUPERIORITY|"A subject was considered completed if they completed all 3 SCI (as indicated in participant flow section) - 13 control, 10 intervention.~However, the mixed model took in to account ALL available data. As such, there were 70 control, 65 intervention that completed at least 1 SCI. Their data was analyzed by the model and used to predict later outcomes so they were considered to be included in the analysis."||||||0.035||||||The mixed model may provide a significantly different change in SCI score from baseline to the 6 month using a per-protocol analysis in the intervention group as compared to the control group. A p value \<0.05 was considered significant.|Mixed Models Analysis|||A multilevel mixed effects linear regression model was used to analyze this data. This analysis allowed for an estimation of missing data. This explains the discrepancy in the number of participant study completion vs participant data analyzed (see below).||||0.035
71643410|NCT02825680|142805071|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||This analysis compares reach within the pre-intervention timeframe versus the post-intervention timeframe for each LEAP (intervention) and control case. Intention to treat analysis was used; all participating facilities randomized to the LEAP (intervention) arm were included whether or not they completed the intervention.||||.011
71643411|NCT01075282|142805072|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of LY2189265 1.5 mg vs insulin glargine on HbA1c change from baseline at the 52-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 20%.||-0.29|-0.60|<0.001
71643412|NCT01075282|142805072|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.13|||<|0.001|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.02|-0.29|<0.001
71762674|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.45||||0.0436||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||0.0436
71643413|NCT01075282|142805072|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.29|-0.60|<0.001
71643414|NCT01075282|142805072|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.05|TWO_SIDED|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.02|-0.29|0.05
71643415|NCT01075282|142805073|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.37|-0.65|<0.001
71643416|NCT01075282|142805073|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.10|-0.38|<0.001
71643417|NCT01075282|142805073|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.37|-0.65|<0.001
71762675|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.17||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135||||
71762676|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.37||||||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
71762677|NCT00488683|143027043|SUPERIORITY_OR_OTHER||R-square|0.07||||||95.0|||||Regression, Linear||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y||||
71762678|NCT05475483|143027066|OTHER||Mean Difference (Final Values)|-1.27|||=|0.045|TWO_SIDED|95.0|-2.51|-0.03|||Mixed Models Analysis|||||-0.03|-2.51|= 0.045
71762679|NCT05475483|143027067|OTHER||Odds Ratio (OR)|2.22|||=|0.078|TWO_SIDED|95.0|0.91|5.37|||Regression, Logistic|||||5.37|0.91|= 0.078
71762680|NCT05475483|143027068|OTHER||Odds Ratio (OR)|1.95||||0.143|TWO_SIDED|95.0|0.8|4.76|||Regression, Logistic|||||4.76|0.80|0.143
71762681|NCT05475483|143027069|OTHER||Mean Difference (Final Values)|-1.78|||=|0.032|TWO_SIDED|95.0|-3.4|-0.16|||Mixed Models Analysis|||||-0.16|-3.40|= 0.032
71762682|NCT02923921|143027105|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.6565|TWO_SIDED|95.0|0.863|1.265|||Log Rank|||The primary test to compare overall survival between treatment arms was the two-sided log-rank test, stratified by region and prior therapy. The estimate of the hazard ration (HR) - (Pegilodecakin + FOLFOX Arm / FOLFOX Arm) and the corresponding 95% CI was computed using a Cox proportional hazards model stratified by randomization stratification factors. Randomization stratification factors were based on the data recorded in interactive voice response system (IVRS).||1.265|0.863|0.6565
71762683|NCT02923921|143027106|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8144|TWO_SIDED|95.0|0.808|1.19|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||1.190|0.808|0.8144
71762684|NCT02923921|143027107|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7044|TWO_SIDED|95.0|0.4|1.7||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.7|0.4|0.7044
71762685|NCT02923921|143027108|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1463|TWO_SIDED|95.0|0.9|1.8||P-value is calculated by Exact Cochran-Mantel-Haenszel test stratified by the randomization strata Prior Therapy - interactive voice response system (IVRS), Geographic Region - IVRS.|Cochran-Mantel-Haenszel|||||1.8|0.9|0.1463
71762686|NCT02923921|143027109|SUPERIORITY||Hazard Ratio (HR)|1.008||||0.9952|TWO_SIDED|95.0|0.37|2.741|||Log Rank|||The estimate of hazard ratio (HR) was stratified by region and prior therapy.||2.741|0.370|0.9952
71762687|NCT02923921|143027110|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.2298|TWO_SIDED|95.0|-11.6|2.8|||Log Rank|||||2.8|-11.6|0.2298
71762688|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|0.96||||0.454|TWO_SIDED|90.0|-1.15|3.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.07|-1.15|0.4540
71762689|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|7.88|||<|0.0001|TWO_SIDED|90.0|5.77|9.99|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||9.99|5.77|< 0.0001
71762690|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|11.33|||<|0.0001|TWO_SIDED|90.0|9.22|13.44|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||13.44|9.22|< 0.0001
71762691|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.0001|TWO_SIDED|90.0|6.48|10.7|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.70|6.48|< 0.0001
71762692|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|8.96|||<|0.0001|TWO_SIDED|90.0|6.85|11.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||11.07|6.85|< 0.0001
71762693|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|8.07|||<|0.0001|TWO_SIDED|90.0|5.96|10.18|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||10.18|5.96|< 0.0001
71762694|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||<|0.0001|TWO_SIDED|90.0|3.42|7.64|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.64|3.42|< 0.0001
71762695|NCT02785770|143027136|SUPERIORITY_OR_OTHER||LS mean difference|3.74||||0.0036|TWO_SIDED|90.0|1.64|5.85|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.85|1.64|0.0036
71762696|NCT02785770|143027137|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.29||||0.8195|TWO_SIDED|90.0|-2.38|1.8|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.80|-2.38|0.8195
71643418|NCT01075282|142805073|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.10|-0.38|<0.001
71643419|NCT01075282|142805073|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.13|-0.50|<0.001
71643420|NCT01075282|142805073|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.03|||<|0.001|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||0.15|-0.21|<0.001
71643421|NCT01075282|142805073|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.13|-0.50|<0.001
71643422|NCT01075282|142805073|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.378|TWO_SIDED|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||0.15|-0.21|0.378
71643423|NCT01075282|142805074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|2.98|7.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.11|2.98|<0.001
71643424|NCT01075282|142805074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.41|3.24||Treatment comparison at 26 weeks.|Regression, Logistic|||||3.24|1.41|<0.001
71643425|NCT01075282|142805074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.001|TWO_SIDED|95.0|2.45|5.75||Treatment comparison at 52 weeks.|Regression, Logistic|||||5.75|2.45|<0.001
71643426|NCT01075282|142805074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.098|TWO_SIDED|95.0|0.94|2.15||Treatment comparison at 52 weeks.|Regression, Logistic|||||2.15|0.94|0.098
71643427|NCT01075282|142805074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.85|4.14||Treatment comparison at 78 weeks.|Regression, Logistic|||||4.14|1.85|<0.001
71643428|NCT01075282|142805074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.334|TWO_SIDED|95.0|0.82|1.82||Treatment comparison at 78 weeks.|Regression, Logistic|||||1.82|0.82|0.334
71643429|NCT01075282|142805075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.9|7.63||Treatment comparison at 26 weeks.|Regression, Logistic|||||7.63|2.90|<0.001
71643430|NCT01075282|142805075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.57|4.11||Treatment comparison at 26 weeks.|Regression, Logistic|||||4.11|1.57|<0.001
71643431|NCT01075282|142805075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.001|TWO_SIDED|95.0|1.81|4.85||Treatment comparison at 52 weeks.|Regression, Logistic|||||4.85|1.81|<0.001
71643432|NCT01075282|142805075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.004|TWO_SIDED|95.0|1.26|3.39||Treatment comparison at 52 weeks.|Regression, Logistic|||||3.39|1.26|0.004
71643433|NCT01075282|142805075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.44|3.57||Treatment comparison at 78 weeks.|Regression, Logistic|Treatment comparison at 78 weeks.||||3.57|1.44|<0.001
71643434|NCT01075282|142805075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.073|TWO_SIDED|95.0|0.96|2.42||Treatment comparison at 78 weeks.|Regression, Logistic|||||2.42|0.96|0.073
71643435|NCT01075282|142805076|SUPERIORITY_OR_OTHER|||||||0.109||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.109
71643436|NCT01075282|142805076|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.335
71643437|NCT01075282|142805076|SUPERIORITY_OR_OTHER|||||||0.091||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.091
71643438|NCT01075282|142805076|SUPERIORITY_OR_OTHER|||||||0.4||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.400
71643439|NCT01075282|142805076|SUPERIORITY_OR_OTHER|||||||0.641||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.641
71643440|NCT01075282|142805076|SUPERIORITY_OR_OTHER|||||||0.055||||||Treatment comparison at 78 weeks.|Mixed Models Analysis|||||||0.055
71643441|NCT01075282|142805079|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|||<|0.001|TWO_SIDED|95.0|2.33|3.33||Treatment comparison at 26 weeks.|ANCOVA|||||3.33|2.33|<0.001
71643442|NCT01075282|142805079|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.99|2.99||Treatment comparison at 26 weeks.|ANCOVA|||||2.99|1.99|<0.001
71643443|NCT01075282|142805079|SUPERIORITY_OR_OTHER||LS Mean Difference|3.31|||<|0.001|TWO_SIDED|95.0|2.71|3.9||Treatment comparison at 52 weeks.|ANCOVA|||||3.90|2.71|<0.001
71643444|NCT01075282|142805079|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|2.17|3.36||Treatment comparison at 52 weeks.|ANCOVA|||||3.36|2.17|<0.001
71643445|NCT01075282|142805079|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|||<|0.001|TWO_SIDED|95.0|2.59|3.89||Treatment comparison at 78 weeks.|ANCOVA|||||3.89|2.59|<0.001
71643446|NCT01075282|142805079|SUPERIORITY_OR_OTHER||LS Mean Difference|2.82|||<|0.001|TWO_SIDED|95.0|2.17|3.46||Treatment comparison at 78 weeks.|ANCOVA|||||3.46|2.17|<0.001
71643447|NCT02709018|142805127|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
71643448|NCT02709018|142805128|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||0.57
71643449|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||4mg/day vs Placebo||||0.814
71643450|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||8 mg/day vs Placebo||||0.013
71643451|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||12 mg/day vs Placebo||||0.287
71643452|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||16 mg/day vs Placebo||||0.027
71643453|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||24 mg/day vs Placebo||||0.390
71643454|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||4mg/day vs Placebo||||0.844
71643455|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||8 mg/day vs Placebo||||0.030
71643456|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||12 mg/day vs Placebo||||0.437
71643457|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||16 mg/day vs Placebo||||0.034
71643458|NCT01494532|142805144|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||24 mg/day vs Placebo||||0.808
71643459|NCT01494532|142805145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.826|TWO_SIDED|95.0|0.398|3.166|||Generalized Estimating Equations model|||||3.166|0.398|0.826
71643460|NCT01494532|142805145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.622||||0.233|TWO_SIDED|95.0|0.732|3.593|||Generalized Estimating Equations model|||||3.593|0.732|0.233
71643461|NCT01494532|142805145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.953||||0.902|TWO_SIDED|95.0|0.439|2.065|||Generalized Estimating Equations model|||||2.065|0.439|0.902
71643462|NCT01494532|142805145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.866||||0.127|TWO_SIDED|95.0|0.837|4.158|||Generalized Estimating Equations model|||||4.158|0.837|0.127
71643463|NCT01494532|142805145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.362||||0.564|TWO_SIDED|95.0|0.477|3.888|||Generalized Estimating Equations model|||||3.888|0.477|0.564
71643464|NCT01494532|142805146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.861|TWO_SIDED|95.0|0.31|2.659|||Generalized Estimating Equations model|||||2.659|0.310|0.861
71643465|NCT01494532|142805146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.608||||0.277|TWO_SIDED|95.0|0.684|3.782|||Generalized Estimating Equations model|||||3.782|0.684|0.277
71643466|NCT01494532|142805146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.869|TWO_SIDED|95.0|0.461|2.5|||Generalized Estimating Equations model|||||2.500|0.461|0.869
71643467|NCT01494532|142805146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.14|TWO_SIDED|95.0|0.808|4.545|||Generalized Estimating Equations model|||||4.545|0.808|0.140
71643468|NCT01494532|142805146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.689||||0.362|TWO_SIDED|95.0|0.547|5.218|||Generalized Estimating Equations model|||||5.218|0.547|0.362
71643469|NCT01494532|142805147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.525|TWO_SIDED|95.0|0.266|1.965|||Generalized Estimating Equations model|||||1.965|0.266|0.525
71643470|NCT01494532|142805147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.851||||0.13|TWO_SIDED|95.0|0.834|4.109|||Generalized Estimating Equations model|||||4.109|0.834|0.130
71643471|NCT01494532|142805147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.992|TWO_SIDED|95.0|0.444|2.232|||Generalized Estimating Equations model|||||2.232|0.444|0.992
71643472|NCT01494532|142805147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.329|TWO_SIDED|95.0|0.674|3.248|||Generalized Estimating Equations model|||||3.248|0.674|0.329
71643473|NCT01494532|142805147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.907||||0.856|TWO_SIDED|95.0|0.315|2.61|||Generalized Estimating Equations model|||||2.610|0.315|0.856
71643474|NCT01494532|142805149|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
71643475|NCT01494532|142805149|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
71643476|NCT01494532|142805149|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
71643477|NCT01494532|142805149|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
71643478|NCT01494532|142805149|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
71643479|NCT01494532|142805150|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
71643480|NCT01494532|142805150|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
71643481|NCT01494532|142805150|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.230
71643482|NCT01494532|142805150|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
71643483|NCT01494532|142805150|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
71643484|NCT01494532|142805151|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
71643485|NCT01494532|142805151|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
71643486|NCT01494532|142805151|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
71643487|NCT01494532|142805151|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
71643488|NCT01494532|142805151|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
71643489|NCT01494532|142805152|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.998
71643490|NCT01494532|142805152|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.017
71643491|NCT01494532|142805152|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.312
71643492|NCT01494532|142805152|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
71643493|NCT01494532|142805152|SUPERIORITY_OR_OTHER|||||||0.659|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.659
71643494|NCT01494532|142805153|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.337
71643495|NCT01494532|142805153|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.126
71643496|NCT01494532|142805153|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.283
71643497|NCT01494532|142805153|SUPERIORITY_OR_OTHER|||||||0.148|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.148
71643498|NCT01494532|142805153|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.581
71643499|NCT01494532|142805154|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.486
71643500|NCT01494532|142805154|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
71643501|NCT01494532|142805154|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.121
71643502|NCT01494532|142805154|SUPERIORITY_OR_OTHER|||||||0.081|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.081
71643503|NCT01494532|142805154|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.187
71643504|NCT01494532|142805155|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.134
71643505|NCT01494532|142805155|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.768
71643506|NCT01494532|142805155|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.859
71643507|NCT01494532|142805155|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.903
71643508|NCT01494532|142805155|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.470
71643509|NCT01494532|142805156|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
71643510|NCT01494532|142805156|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
71643511|NCT01494532|142805156|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
71643512|NCT01494532|142805156|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
71762697|NCT02785770|143027137|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.0004|TWO_SIDED|90.0|2.44|6.64|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.64|2.44|0.0004
71762698|NCT02785770|143027138|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.9146|TWO_SIDED|90.0|-1.95|2.22|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.22|-1.95|0.9146
71762699|NCT02785770|143027138|SUPERIORITY_OR_OTHER||LS mean difference|5.04|||<|0.0001|TWO_SIDED|90.0|2.95|7.14|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.14|2.95|<0.0001
71762700|NCT02785770|143027139|SUPERIORITY_OR_OTHER||LS mean difference|1.24||||0.3272|TWO_SIDED|90.0|-0.84|3.33|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.33|-0.84|0.3272
71762701|NCT02785770|143027139|SUPERIORITY_OR_OTHER||LS mean difference|4.26||||0.0009|TWO_SIDED|90.0|2.16|6.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||6.36|2.16|0.0009
71762702|NCT02785770|143027140|SUPERIORITY_OR_OTHER||LS mean difference|-0.48||||0.7024|TWO_SIDED|90.0|-2.57|1.6|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.60|-2.57|0.7024
71643513|NCT01494532|142805156|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
71643514|NCT01494532|142805157|SUPERIORITY_OR_OTHER|||||||0.734|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.734
71643515|NCT01494532|142805157|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.048
71643516|NCT01494532|142805157|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.443
71643517|NCT01494532|142805157|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.123
71643518|NCT01494532|142805157|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.641
71643519|NCT01494532|142805158|SUPERIORITY_OR_OTHER|||||||0.822|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.822
71643520|NCT01494532|142805158|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.025
71643521|NCT01494532|142805158|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.267
71643522|NCT01494532|142805158|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
71643523|NCT01494532|142805158|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.458
71643524|NCT01494532|142805159|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.814
71643525|NCT01494532|142805159|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.013
71643526|NCT01494532|142805159|SUPERIORITY_OR_OTHER|||||||0.287|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.287
71643527|NCT01494532|142805159|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.027
71643528|NCT01494532|142805159|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.390
71643529|NCT01494532|142805160|SUPERIORITY_OR_OTHER|||||||0.376|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.376
71643530|NCT01494532|142805160|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.036
71643531|NCT01494532|142805160|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.362
71643532|NCT01494532|142805160|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.089
71643533|NCT01494532|142805160|SUPERIORITY_OR_OTHER|||||||0.403|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.403
71643534|NCT01494532|142805161|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.419
71643535|NCT01494532|142805161|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.026
71643536|NCT01494532|142805161|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.230
71643537|NCT01494532|142805161|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.033
71643538|NCT01494532|142805161|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.266
71643539|NCT01494532|142805162|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.073
71643540|NCT01494532|142805162|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.996
71643541|NCT01494532|142805162|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.791
71643542|NCT01494532|142805162|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.747
71643543|NCT01494532|142805162|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.600
71643544|NCT01494532|142805163|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.007
71643545|NCT01494532|142805163|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.014
71643546|NCT01494532|142805163|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.016
71643547|NCT01494532|142805163|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
71643548|NCT01494532|142805163|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.008
71643549|NCT01494532|142805164|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.047
71643550|NCT01494532|142805164|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.005
71643551|NCT01494532|142805164|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.172
71643552|NCT01494532|142805164|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.034
71643553|NCT01494532|142805164|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.039
71643554|NCT01494532|142805165|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.292
71643555|NCT01494532|142805165|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.068
71643556|NCT01494532|142805165|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.170
71643557|NCT01494532|142805165|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.003
71643558|NCT01494532|142805165|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.153
71643559|NCT01494532|142805166|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.409
71643560|NCT01494532|142805166|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.598
71643561|NCT01494532|142805166|SUPERIORITY_OR_OTHER|||||||0.992|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.992
71643562|NCT01494532|142805166|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.169
71643563|NCT01494532|142805166|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED|95.0||||Mixed Model Repeated Measures|Mixed Models Analysis|||||||0.348
71643564|NCT02571907|142805173|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the primary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 91.2%, which was greater than the performance goal of 55%.|||
71643565|NCT02571907|142805174|OTHER||||||||||||||||||A Bayesian beta-binomial model with a Uniform(0, 1) prior was used to compute a 95% credible interval for the proportion of patients meeting the secondary endpoint. The lower bound of this credible interval (2.5th percentile of the posterior distribution) was 70.8%, which was greater than the performance goal of 46%.|||
71643566|NCT03666026|142805175|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.03||||||||1.03|1.00|
71643567|NCT03666026|142805175|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
71643568|NCT03666026|142805175|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04||||||||1.04|1.00|
71643569|NCT01343004|142805180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71643570|NCT01343004|142805180|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71643571|NCT01343004|142805181|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643572|NCT01343004|142805181|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643573|NCT01343004|142805181|SUPERIORITY_OR_OTHER|||||||0.8155|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.8155
71643574|NCT01343004|142805182|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643575|NCT01343004|142805182|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643576|NCT01343004|142805182|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643577|NCT01343004|142805183|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643578|NCT01343004|142805183|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||<0.0001
71643579|NCT01343004|142805183|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.||||||0.0004
71643580|NCT01343004|142805184|SUPERIORITY_OR_OTHER|||||||0.0318|||||||Chi-squared|||||||0.0318
71643581|NCT01343004|142805184|SUPERIORITY_OR_OTHER|||||||0.2304|||||||Chi-squared|||||||0.2304
71643582|NCT01343004|142805184|SUPERIORITY_OR_OTHER|||||||0.3361|||||||Chi-squared|||||||0.3361
71643583|NCT00526188|142805189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.46||||||95.0|6.0|12.93|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.||12.93|6.00|
71823664|NCT04319094|143150914|SUPERIORITY||Mean Difference (Net)|1.79|STANDARD_ERROR_OF_MEAN|0.54||0.001|TWO_SIDED|95.0|0.72|2.86|||Mixed Models Analysis|Degrees of freedom: 421|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.86|0.72|0.001
71886171|NCT00662792|143292985|SUPERIORITY||Difference of adjusted means|2.8|STANDARD_ERROR_OF_MEAN|3.2||0.3775|TWO_SIDED|95.0|-3.5|9.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||9.1|-3.5|0.3775
71886172|NCT00662792|143292985|SUPERIORITY||Difference of adjusted means|7.1|STANDARD_ERROR_OF_MEAN|3.2||0.0285|TWO_SIDED|95.0|0.7|13.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||13.4|0.7|0.0285
71643584|NCT00526188|142805190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.81||||||95.0|1.84|7.78|||Test performed based on the 95% CI||Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.||7.78|1.84|
71643585|NCT00526188|142805191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.36||||||95.0|7.45|15.28|||Test performed based on the 95% CI||Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI|Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.||15.28|7.45|
71643586|NCT00772603|142805214|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.3|||=|0.003|TWO_SIDED|95.0|-30.4|-5.8||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-5.80|-30.40|=0.003
71660932|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.190
71886173|NCT00662792|143292985|SUPERIORITY||Difference of adjusted means|-8.9|STANDARD_ERROR_OF_MEAN|3.2||0.0065|TWO_SIDED|95.0|-15.2|-2.5|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||-2.5|-15.2|0.0065
71886174|NCT00662792|143292989|SUPERIORITY||Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|2.4||0.0182|TWO_SIDED|95.0|1.0|10.4|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning PEF||10.4|1.0|0.0182
71643587|NCT00772603|142805214|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.3|||=|0.078|TWO_SIDED|95.0|-22.3|1.2||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||1.20|-22.30|=0.078
71643588|NCT00772603|142805215|SUPERIORITY_OR_OTHER||Median Difference (Net)|-33.0|||=|0.003|TWO_SIDED|95.0|-33.0|-6.3||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||-6.30|-33.00|=0.003
71643589|NCT00772603|142805215|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.3|||=|0.589|TWO_SIDED|95.0|-16.2|9.7||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.||9.70|-16.20|=0.589
71643590|NCT00772603|142805216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983|||=|0.018|TWO_SIDED|95.0|1.126|3.494|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||3.494|1.126|=0.018
71643591|NCT00772603|142805216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||=|0.075||95.0|0.95|2.937|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.||2.937|0.950|=0.075
71643592|NCT00772603|142805217|SUPERIORITY_OR_OTHER||||||=|0.013||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.013
71643593|NCT00772603|142805217|SUPERIORITY_OR_OTHER||||||=|0.528||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.||||=0.528
71643594|NCT00772603|142805218|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.008
71643595|NCT00772603|142805218|SUPERIORITY_OR_OTHER||||||=|0.0546||95.0|||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.||||=0.0546
71643596|NCT00446966|142805229|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71643597|NCT00834132|142805234|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|94.81||||||90.0|84.77|106.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.04|84.77|
71643598|NCT00834132|142805235|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.89||||||90.0|96.0|106.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.03|96.00|
71643599|NCT00834132|142805236|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.14||||||90.0|96.05|106.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.49|96.05|
71762703|NCT02785770|143027140|SUPERIORITY_OR_OTHER||LS mean difference|2.26||||0.0768|TWO_SIDED|90.0|0.16|4.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.36|0.16|0.0768
71643600|NCT02888756|142805243|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).||||0.14
71643601|NCT00488774|142805254|SUPERIORITY_OR_OTHER|||||||0.467|||||||Chi-squared|||||||0.467
71762704|NCT02785770|143027141|SUPERIORITY_OR_OTHER||LS mean difference|-1.97||||0.1201|TWO_SIDED|90.0|-4.06|0.12|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.12|-4.06|0.1201
71762705|NCT02785770|143027141|SUPERIORITY_OR_OTHER||LS mean difference|1.21||||0.3424|TWO_SIDED|90.0|-0.89|3.31|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.31|-0.89|0.3424
71762706|NCT02785770|143027142|SUPERIORITY_OR_OTHER||LS mean difference|-1.35||||0.287|TWO_SIDED|90.0|-3.44|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.44|0.2870
71762707|NCT02785770|143027142|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.9334|TWO_SIDED|90.0|-2.21|1.99|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-2.21|0.9334
71643602|NCT00488774|142805254|SUPERIORITY_OR_OTHER|||||||0.081|||||||Chi-squared|||||||0.081
71643603|NCT00488774|142805254|SUPERIORITY_OR_OTHER|||||||0.145|||||||Chi-squared|||||||0.145
71643604|NCT00488774|142805255|SUPERIORITY_OR_OTHER|||||||0.832|||||||Chi-squared|||||||0.832
71823665|NCT04319094|143150914|SUPERIORITY||Mean Difference (Net)|0.93|STANDARD_ERROR_OF_MEAN|0.67||0.18|TWO_SIDED|95.0|-0.39|2.25||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.25|-0.39|0.18
71643605|NCT00488774|142805255|SUPERIORITY_OR_OTHER|||||||0.37|||||||Chi-squared|||||||0.370
71643606|NCT00488774|142805255|SUPERIORITY_OR_OTHER|||||||0.702|||||||Chi-squared|||||||0.702
71823666|NCT04319094|143150914|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.68||0.11|TWO_SIDED|95.0|-0.24|2.45||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|2.45|-0.24|0.11
71823667|NCT04319094|143150914|SUPERIORITY||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|0.65||0.0006|TWO_SIDED|95.0|0.98|3.54||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.54|0.98|0.0006
71823668|NCT04319094|143150914|SUPERIORITY||Mean Difference (Net)|2.48|STANDARD_ERROR_OF_MEAN|0.75||0.001|TWO_SIDED|95.0|1.01|3.95||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 421|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean GSES scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|3.95|1.01|0.001
71823669|NCT04319094|143150914|SUPERIORITY|||||||0.1195|||||||Mixed Models Analysis|||Null hypothesis: There is no difference in the change of GSES scores over time between the control and PEERS participants.||||0.1195
71886175|NCT00662792|143292989|SUPERIORITY||Difference of adjusted means|6.3|STANDARD_ERROR_OF_MEAN|2.4||0.0091|TWO_SIDED|95.0|1.6|11.1|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning PEF||11.1|1.6|0.0091
71643607|NCT04590027|142805256|NON_INFERIORITY|power calculation was not recorded Definition of non inferiority: two point difference of pain score at the measurement times|||||<|0.05|||||||ANCOVA|To rule out confounders due to an age difference, the ANCOVA test was applied to compare the differences in pain scores age-unrelatedly.|||Fisher Yates Test to compare the requirement of resue medication|||<0.05
71643608|NCT04590027|142805257|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71643609|NCT00075478|142805274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||Reference arm is Arm 2.||1.1|0.3|.09
71643610|NCT00075478|142805275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.59|TWO_SIDED|95.0|0.1|3.0|||Regression, Cox|||||3.0|0.1|0.59
71643611|NCT00075478|142805276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.06|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.06
71643612|NCT00075478|142805277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.09|TWO_SIDED|95.0|0.3|1.1|||Regression, Cox|||||1.1|0.3|0.09
71643613|NCT00075478|142805278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.16|TWO_SIDED|95.0|0.8|3.1|||Regression, Cox|||||3.1|0.8|0.16
71643614|NCT00075478|142805279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.52||||0.14|TWO_SIDED|95.0|0.9|2.7|||Regression, Cox|||||2.7|0.9|0.14
71643615|NCT00075478|142805281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.05|TWO_SIDED|95.0|0.3|1.0|||Regression, Cox|||||1.0|0.3|0.05
71643616|NCT00462228|142805311|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.55
71643617|NCT00462228|142805311|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||1.00
71886176|NCT00662792|143292989|SUPERIORITY||Difference of adjusted means|-8.0|STANDARD_ERROR_OF_MEAN|2.4||0.001|TWO_SIDED|95.0|-12.8|-3.3|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning PEF||-3.3|-12.8|0.0010
71823670|NCT04319094|143150915|SUPERIORITY||Mean Difference (Net)|3.22|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|1.71|4.73||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: post-intervention - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to post-intervention for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.73|1.71|<0.0001
71823671|NCT04319094|143150915|SUPERIORITY||Mean Difference (Net)|2.59|STANDARD_ERROR_OF_MEAN|1.03||0.0123|TWO_SIDED|95.0|0.57|4.62||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 3-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 3-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.62|0.57|0.0123
71823672|NCT04319094|143150915|SUPERIORITY||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|1.02||0.01|TWO_SIDED|95.0|0.63|4.63||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 6-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 6-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|4.63|0.63|0.01
71823673|NCT04319094|143150915|SUPERIORITY||Mean Difference (Net)|4.18|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|2.32|6.04||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 9-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 9-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|6.04|2.32|<0.0001
71823674|NCT04319094|143150915|SUPERIORITY||Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.17||0.0078|TWO_SIDED|95.0|0.83|5.44||The a priori threshold for statistical significance is p=0.05.|Mixed Models Analysis|Degrees of freedom: 361|Score difference: 12-month - baseline|Null hypothesis: there is no difference in the mean Brief-COPE Adaptive Coping scores from baseline to 12-month for all study participants.|A series of generalized linear mixed-effect models were implemented to predict the outcome measurements. The primary fixed effect predictors were group (control vs. PEERS), time (categorical), and group \* time. Random terms in all models were: study participants and their interaction with time. The covariance of dependent variable values across time was modeled as a first-order auto-regression decaying function (AR1). Higher order fixed and random terms were pretested and removed from the model if nonsignificant.|5.44|0.83|0.0078
71823675|NCT04319094|143150915|SUPERIORITY|||||||0.1408|||||||Mixed Models Analysis|||Null hypothesis: there is no statistical difference in the change in adaptive coping over time between control and PEERS participants.||||0.1408
71823676|NCT04956692|143150916|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.04|||<|0.0001|TWO_SIDED|96.0|0.98|1.1||The one-sided p-value non-inferiority boundary is 0.02|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||1.10|0.98|<0.0001
71823677|NCT04956692|143150917|NON_INFERIORITY|The non-inferiority margin with respect to the geometric means ratio (GMR) was 0.8|Geometric Mean Ratio (GMR)|1.85|||<|0.0001|TWO_SIDED|94.0|1.69|2.03||The one-sided p-value non-inferiority boundary is 0.03|t-test, 1 sided|Welch's unequal variances t-test. The null hypothesis was that GMR≤0.8.|Numerator Arm A/Denominator Arm B|||2.03|1.69|<0.0001
71823678|NCT01016353|143150932|SUPERIORITY|||||||0.06|||||||Log Rank|||||||0.06
71823679|NCT01822821|143150933|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was tested using a noninferiority margin of 1.15.|ratio of geometric means|0.89||||0.08|ONE_SIDED|90.0||1.06|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.06||0.08
71823680|NCT01822821|143150933|SUPERIORITY_OR_OTHER||ratio of geometric means|0.89||||0.28|ONE_SIDED|95.0||1.1|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.|||1.10||0.28
71823681|NCT01822821|143150934|NON_INFERIORITY_OR_EQUIVALENCE|We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.|Median Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|90.0||-0.5|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.5||< 0.001
71823682|NCT01822821|143150934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.001|ONE_SIDED|95.0||-0.42|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.|||-0.42||< 0.001
71643618|NCT00462228|142805311|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.||||0.45
71643619|NCT00462228|142805311|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.||||0.43
71643620|NCT00462228|142805312|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||6 week comparison,alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores||||0.23
71643621|NCT00462228|142805312|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.022
71643622|NCT00462228|142805312|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores.||||0.06
71643623|NCT00462228|142805312|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.||||0.027
71643624|NCT00462228|142805313|SUPERIORITY_OR_OTHER|||||||1||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||1.0
71643625|NCT00462228|142805313|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.55
71643626|NCT00462228|142805313|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.||||0.81
71643627|NCT00462228|142805313|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.||||0.57
71643628|NCT00462228|142805314|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.55
71643629|NCT00462228|142805314|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||1.0
71643630|NCT00462228|142805314|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.||||0.17
71643631|NCT00462228|142805314|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.||||0.64
71643632|NCT00462228|142805315|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R total recall scores.||||0.34
71643633|NCT00462228|142805315|SUPERIORITY_OR_OTHER|||||||1||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||1.0
71643634|NCT00462228|142805315|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall scores.||||0.54
71643635|NCT00462228|142805315|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.||||0.91
71643636|NCT00462228|142805316|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.34
71643637|NCT00462228|142805316|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.55
71643638|NCT00462228|142805316|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.||||0.37
71643639|NCT00462228|142805316|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.||||0.95
71643640|NCT00462228|142805317|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.75
71643641|NCT00462228|142805317|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.51
71643642|NCT00462228|142805317|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.||||0.31
71643643|NCT00462228|142805317|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.||||0.46
71643644|NCT00462228|142805318|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.34
71643645|NCT00462228|142805318|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.75
71643646|NCT00462228|142805318|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.||||0.37
71643647|NCT00462228|142805318|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.||||0.45
71643648|NCT03437265|142805325|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71643649|NCT03437265|142805326|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71643650|NCT03437265|142805327|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71643651|NCT03437265|142805328|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71643652|NCT03437265|142805329|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented.|||
71643653|NCT03437265|142805330|OTHER||||||||||||||||||PK parameters were estimated for each subject by non-compartmental analysis methods using Phoenix® WinNonlin® software (v8.0, Certara USA, Inc., USA). Summary statistics (n, mean, SD, CV%, median, minimum, maximum, geometric n, geometric mean (geometric SD) and geometric CV%) were presented. The Geometric CV for glycolic acid was Not Calculated (appears as 0%).|||
71643654|NCT03437265|142805331|OTHER||||||||||||||||||Summary of the number of bowel movements per time period for the PD analysis set|||
71643655|NCT03437265|142805332|OTHER||||||||||||||||||The time (in minutes) to achieve clear effluent/time to turbid contents is presented for the PD analysis set.|||
71643656|NCT00840476|142805342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.26||||||90.0|93.12|107.95|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107.95|93.12|
71643657|NCT00840476|142805343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|105.14||||||90.0|100.27|110.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.25|100.27|
71643658|NCT00840476|142805344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|104.33||||||90.0|99.16|109.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.76|99.16|
71643659|NCT00835263|142805345|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.23||||||90.0|100.78|105.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.73|100.78|
71643660|NCT00835263|142805346|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.31||||||90.0|100.75|105.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.93|100.75|
71643661|NCT00835263|142805347|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|102.14||||||90.0|100.06|104.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.26|100.06|
71643662|NCT00848536|142805348|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
71660933|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.388||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.388
71643663|NCT00848536|142805349|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.8|0.6|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||00.6|-0.8|
71762708|NCT02785770|143027143|SUPERIORITY_OR_OTHER||LS mean difference|-2.16||||0.0893|TWO_SIDED|90.0|-4.24|-0.07|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.07|-4.24|0.0893
71643664|NCT00848536|142805350|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was \< 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.||0.5|-0.9|
71643665|NCT03261167|142805358|OTHER||Difference|18.1|||||TWO_SIDED|95.0|1.1|35.0||||||||35.0|1.1|
71643666|NCT03261167|142805359|OTHER||Adjusted rate difference|33.1|||||TWO_SIDED|95.0|17.0|49.2|||||Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||49.2|17.0|
71762709|NCT02785770|143027143|SUPERIORITY_OR_OTHER||LS mean difference|-2.61||||0.0412|TWO_SIDED|90.0|-4.71|-0.51|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.51|-4.71|0.0412
71643667|NCT03261167|142805359|OTHER||Adjusted rate difference|21.7|||||TWO_SIDED|95.0|4.9|38.5|||||Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||38.5|4.9|
71643668|NCT03261167|142805359|OTHER||Adjusted rate difference|18.4|||||TWO_SIDED|95.0|1.3|35.5|||||Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||35.5|1.3|
71643669|NCT03261167|142805359|OTHER||Adjusted rate difference|12.9|||||TWO_SIDED|95.0|-4.2|30.1|||||Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||30.1|-4.2|
71643670|NCT03261167|142805359|OTHER||Adjusted rate difference|-5.6|||||TWO_SIDED|95.0|-20.9|9.8|||||Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||9.8|-20.9|
71643671|NCT03261167|142805359|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-23.0|5.9|||||Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||5.9|-23.0|
71643672|NCT03261167|142805359|OTHER||Adjusted rate difference|-12.1|||||TWO_SIDED|95.0|-27.5|3.2|||||Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.2|-27.5|
71643673|NCT03261167|142805359|OTHER||Adjusted rate difference|-9.6|||||TWO_SIDED|95.0|-27.2|7.9|||||Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||7.9|-27.2|
71823683|NCT01822821|143150935|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||0.35|TWO_SIDED|99.4|0.34|1.7|||Regression, Logistic||Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.|||1.7|0.34|0.35
71823684|NCT01822821|143150936|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.13|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 8 hours after surgery.||0|0|0.13
71643674|NCT03261167|142805359|OTHER||Adjusted rate difference|-8.6|||||TWO_SIDED|95.0|-21.9|4.7|||||Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||4.7|-21.9|
71643675|NCT03261167|142805359|OTHER||Adjusted rate difference|-10.4|||||TWO_SIDED|95.0|-24.3|3.4|||||Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||3.4|-24.3|
71643676|NCT03261167|142805359|OTHER||Adjusted rate difference|-8.9|||||TWO_SIDED|95.0|-23.8|6.0|||||Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.0|-23.8|
71643677|NCT03261167|142805359|OTHER||Adjusted rate difference|-0.1|||||TWO_SIDED|95.0|-17.7|17.4|||||Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.4|-17.7|
71643678|NCT03261167|142805359|OTHER||Adjusted rate difference|-9.9|||||TWO_SIDED|95.0|-26.4|6.5|||||Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||6.5|-26.4|
71643679|NCT03261167|142805359|OTHER||Adjusted rate difference|-6.7|||||TWO_SIDED|95.0|-23.6|10.3|||||Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||10.3|-23.6|
71643680|NCT03261167|142805359|OTHER||Adjusted rate difference|-1.5|||||TWO_SIDED|95.0|-18.8|15.7|||||Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||15.7|-18.8|
71643681|NCT03261167|142805359|OTHER||Adjusted rate difference|-0.5|||||TWO_SIDED|95.0|-18.8|17.9|||||Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.|||17.9|-18.8|
71643682|NCT03261167|142805360|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.75|-0.22|||||Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.22|-0.75|
71643683|NCT03261167|142805360|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-0.71|-0.13|||||Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.13|-0.71|
71643684|NCT03261167|142805360|OTHER||Mean Difference (Net)|-0.37|||||TWO_SIDED|95.0|-0.71|-0.04|||||Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.71|
71643685|NCT03261167|142805360|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.51|-0.02|||||Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.02|-0.51|
71643686|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.27|0.42|||||Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.42|-0.27|
71643687|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.25|0.46|||||Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.46|-0.25|
71643688|NCT03261167|142805360|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.33|||||Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.33|-0.37|
71643689|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.19|0.38|||||Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.19|
71643690|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.23|0.43|||||Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.43|-0.23|
71643691|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.17|0.52|||||Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.52|-0.17|
71823685|NCT01822821|143150936|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.44|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 16 hours after surgery.||0|0|0.44
71643692|NCT03261167|142805360|OTHER||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.2|0.48|||||Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.48|-0.20|
71643693|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.34|||||Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.34|-0.25|
71643694|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-0.08|0.63|||||Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.63|-0.08|
71643695|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.23|0.51|||||Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.51|-0.23|
71643696|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.33|0.38|||||Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.38|-0.33|
71823686|NCT01822821|143150936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.38|TWO_SIDED|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 24 hours after surgery||0|0|0.38
71823687|NCT01822821|143150937|SUPERIORITY_OR_OTHER||ratio of geometric means|1.3||||0.46|TWO_SIDED|99.4|0.52|3.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||3.20|0.52|0.46
71886177|NCT00662792|143292989|SUPERIORITY||Difference of adjusted means|11.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|5.8|16.2|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening PEF||16.2|5.8|<.0001
71886178|NCT00662792|143292989|SUPERIORITY||Difference of adjusted means|23.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|18.1|28.6|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening PEF||28.6|18.1|<.0001
71886179|NCT00662792|143292989|SUPERIORITY||Difference of adjusted means|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.5766|TWO_SIDED|95.0|-3.8|6.8|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening PEF||6.8|-3.8|0.5766
71886180|NCT00662792|143292990|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.016||0.0137|TWO_SIDED|95.0|0.008|0.071|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Morning FEV1||0.071|0.008|0.0137
71886181|NCT00662792|143292990|SUPERIORITY||Difference of adjusted means|0.027|STANDARD_ERROR_OF_MEAN|0.016||0.0981|TWO_SIDED|95.0|-0.005|0.059|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Morning FEV1||0.059|-0.005|0.0981
71886182|NCT00662792|143292990|SUPERIORITY||Difference of adjusted means|-0.022|STANDARD_ERROR_OF_MEAN|0.016||0.1827|TWO_SIDED|95.0|-0.054|0.01|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Morning FEV1||0.010|-0.054|0.1827
71886183|NCT00662792|143292990|SUPERIORITY||Difference of adjusted means|0.057|STANDARD_ERROR_OF_MEAN|0.018||0.0014|TWO_SIDED|95.0|0.022|0.092|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Evening FEV1||0.092|0.022|0.0014
71886184|NCT00662792|143292990|SUPERIORITY||Difference of adjusted means|0.105|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.07|0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Evening FEV1||0.140|0.070|<.0001
71886185|NCT00662792|143292990|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.018||0.2584|TWO_SIDED|95.0|-0.015|0.056|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Evening FEV1||0.056|-0.015|0.2584
71886186|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0027|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.02|-0.11|0.0027
71886187|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.4587|TWO_SIDED|95.0|-0.06|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||0.03|-0.06|0.4587
71886188|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1535|TWO_SIDED|95.0|-0.01|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.08|-0.01|0.1535
71886189|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0002|TWO_SIDED|95.0|-0.14|-0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.05|-0.14|0.0002
71886190|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0006|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||-0.04|-0.14|0.0006
71886191|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.5784|TWO_SIDED|95.0|-0.06|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.04|-0.06|0.5784
71886192|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.02||0.0003|TWO_SIDED|95.0|-0.14|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|24 hours||-0.04|-0.14|0.0003
71886193|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|-0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED|95.0|-0.12|-0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|24 hours||-0.02|-0.12|0.0042
71643697|NCT03261167|142805360|OTHER||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.31|0.47|||||Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.47|-0.31|
71643698|NCT03261167|142805361|OTHER||Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.48|0.0|||||Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.|||0.00|-0.48|
71643699|NCT03261167|142805361|OTHER||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.42|0.09|||||Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.09|-0.42|
71643700|NCT03261167|142805361|OTHER||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.37|0.08|||||Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||0.08|-0.37|
71643701|NCT03261167|142805361|OTHER||Mean Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.52|-0.04|||||Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.|||-0.04|-0.52|
71643702|NCT02284867|142805391|NON_INFERIORITY_OR_EQUIVALENCE|"Multivariable binary logistic regression was done to examine the relation between CD16+ NK and preterm labor as adjusted for other confounding factors the enter method was used to build the regression model.~A two-sided p-value \<0.05 was considered statistically significant."|Odds Ratio (OR)|65.01|STANDARD_ERROR_OF_MEAN|1.14|<|0.0002|TWO_SIDED|95.0|6.96|606.76||To our best of known , no previous human studies was analyzing this issue|Regression, Logistic|||"Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value \<0.05 was considered statistically significant."||606.76|6.96|<0.0002
71643703|NCT01604941|142805396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.296|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.2960
71823688|NCT01822821|143150938|SUPERIORITY_OR_OTHER||ratio of geometric means|0.93||||0.38|TWO_SIDED|99.4|0.74|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.74|0.38
71823689|NCT01822821|143150939|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.12|TWO_SIDED|99.4|0.94|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.|||1.20|0.94|0.12
71823690|NCT01822821|143150940|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.31|TWO_SIDED|99.4|0.9|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.9|0.31
71643704|NCT01604941|142805396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0400
71643705|NCT01604941|142805396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6303|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.6303
71643706|NCT01604941|142805397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0365|TWO_SIDED|||||P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0365
71643707|NCT01604941|142805397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0019
71643708|NCT01604941|142805397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.1695
71643709|NCT01604941|142805398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.0394
71643710|NCT01604941|142805398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0004
71643711|NCT01604941|142805398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0332|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.0332
71643712|NCT01604941|142805399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3202|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.3202
71643713|NCT01604941|142805399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4549|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.4549
71643714|NCT01604941|142805399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.3291
71643715|NCT01604941|142805400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6703|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for 50 mg/kg/d dosing||||0.6703
71643716|NCT01604941|142805400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2618|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for all participants with BID dosing||||0.2618
71643717|NCT01604941|142805400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7679|TWO_SIDED|||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 16 for all participants with BID dosing||||0.7679
71823691|NCT01822821|143150941|SUPERIORITY_OR_OTHER||ratio of geometric means|1.0||||0.98|TWO_SIDED|99.4|0.8|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.2|0.8|0.98
71643718|NCT01604941|142805401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1683|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing||||0.1683
71643719|NCT01604941|142805401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0123|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing||||0.0123
71643720|NCT01604941|142805401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2334|TWO_SIDED|||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing||||0.2334
71643721|NCT02450539|142805414|SUPERIORITY||Hazard Ratio (HR)|1.765||||0.0068|TWO_SIDED|95.0|1.165|2.672|||Stratified log-rank test.||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.672|1.165|0.0068
71643722|NCT02450539|142805417|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1746|TWO_SIDED|95.0|0.879|2.022|||Stratified log-rank test||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).\]||2.022|0.879|0.1746
71643723|NCT02450539|142805418|SUPERIORITY||Rate Difference|-17.9|||||TWO_SIDED|95.0|-29.3|-6.6|||||Confidence intervals are based on the normal approximation to the binomial.|||-6.6|-29.3|
71643724|NCT02450539|142805419|SUPERIORITY||Rate Difference|-13.2|||||TWO_SIDED|95.0|-29.2|2.8|||||Confidence intervals are based on the normal approximation to the binomial.|||2.8|-29.2|
71823692|NCT01822821|143150942|SUPERIORITY_OR_OTHER||ratio of geometric means|1.1||||0.4|TWO_SIDED|99.4|0.87|1.3|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.|||1.3|0.87|0.40
71823693|NCT05780047|143150943|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823694|NCT05780047|143150944|OTHER||||||<|0.05|||||||paired samples t-test|||Paired samples t-tests were run to compare whether EHL knowledge, attitudes and behavior changed after the intervention. EHL scores were expected to increase between pre and post testing.||||<0.05
71643725|NCT02450539|142805420|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.7039|TWO_SIDED|95.0|0.502|2.792|||Stratified Log Rank||Stratified Cox regression model.|Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (\<=9 months vs \>9 months).||2.792|0.502|0.7039
71643726|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|||||||||Headache||||
71643727|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|||||||||Diarrhea||||
71643728|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Mean core symptom severity||||
71643729|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|||||||||Mean interference||||
71643730|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean lung cancer symptom severity||||
71643731|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|||||||||Mean core plus lung cancer symptom severity||||
71643732|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|||||||||Mean brain tumor symptom severity||||
71643733|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|||||||||Mean core plus lung worst 5 symptoms severity||||
71643734|NCT02450539|142805421|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|||||||||Rash||||
71643735|NCT02450539|142805422|SUPERIORITY||Mean Difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|||||||||EQ VAS Overall Self-rated Health Score||||
71643736|NCT02450539|142805423|SUPERIORITY||Median Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|||||||||EQ-5D-5L Index Value||||
71643737|NCT01640197|142805445|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643738|NCT01640197|142805446|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643739|NCT01640197|142805447|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643740|NCT01640197|142805448|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643741|NCT01640197|142805449|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643742|NCT01640197|142805450|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643743|NCT01640197|142805451|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71643744|NCT00115063|142805498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71643745|NCT00115063|142805499|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71643746|NCT00115063|142805500|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for systolic blood pressure mean.|t-test, 2 sided|||||||0.09
71643747|NCT00115063|142805500|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value for dystolic blood pressure mean.|t-test, 2 sided|||||||0.60
71643748|NCT00115063|142805501|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for LDL cholesterol|t-test, 2 sided|||||||0.73
71643749|NCT00115063|142805501|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for HDL cholesterol|t-test, 2 sided|||||||0.01
71643750|NCT00115063|142805501|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value for triglycerides|t-test, 2 sided|||||||0.42
71823695|NCT04873817|143150947|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
71823696|NCT00665561|143150949|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.42|0.67||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.||0.67|0.42|
71823697|NCT00665561|143150950|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.12|5.88||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||5.88|0.12|
71643751|NCT00115063|142805501|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for uric acid|t-test, 2 sided|||||||0.05
71643752|NCT00115063|142805502|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
71643753|NCT00115063|142805503|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71643754|NCT01447511|142805513|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||<0.0001
71643755|NCT01447511|142805513|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.0001
71643756|NCT01447511|142805513|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||<0.0001
71643757|NCT01447511|142805513|SUPERIORITY_OR_OTHER||||||=|0.3058|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.||||=0.3058
71823698|NCT00665561|143150951|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.66|1.33||||||All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.33|0.66|
71823699|NCT00665561|143150951|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.29|1.31||||||AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.31|0.29|
71823700|NCT00665561|143150951|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.71|1.58||||||Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.58|0.71|
71643758|NCT01447511|142805513|SUPERIORITY_OR_OTHER||||||=|0.3278|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.||||=0.3278
71643759|NCT01447511|142805513|SUPERIORITY_OR_OTHER||||||=|0.6155|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.||||=0.6155
71643760|NCT01125163|142805531|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0||||All infants were analyzed according to their assigned groups.|Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.59
71643761|NCT01125163|142805532|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.||||0.64
71643762|NCT01030133|142805548|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|0.75||||||0.05
71643763|NCT04517604|142805571|SUPERIORITY||Mean Difference (Final Values)|-5.02|STANDARD_DEVIATION|4.984||0.343|TWO_SIDED|95.0|-16.52|6.47||no adjustment for multiple comparisons as was a pilot|Mixed Models Analysis|||||6.47|-16.52|.343
71643764|NCT04517604|142805572|SUPERIORITY|This was a pilot study funded under a pilot funding mechanism which specifically did not require a power analysis.|Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|0.42||0.0026|TWO_SIDED|95.0|-2.63|-0.77||no test for multiple comparisons as this was a pilot study|Mixed Models Analysis|||This was an open-label, single group study using a within subject design. We compared pre-treatment values to post-treatment values.||-.77|-2.63|.0026
71643765|NCT02635750|142805595|OTHER||Adjusted gMean ratio(%)|99.95|||||TWO_SIDED|90.0|89.502|111.62|||||"Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+ don / BI 409306).~Intra-individual coefficient of variation (gCV (%)) = 18.6."|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||111.62|89.502|
71643766|NCT02635750|142805596|OTHER||Adjusted gMean ratio(%)|100.82|||||TWO_SIDED|90.0|81.861|124.17|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don / BI 409306). Intra-individual coefficient of variation (gCV (%)) = 35.8.|"The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||124.17|81.861|
71643767|NCT02635750|142805597|OTHER||Adjusted gMean ratio (%)|100.84|||||TWO_SIDED|90.0|97.584|104.19|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 4.9.|The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||104.19|97.584|
71660934|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.109
71823701|NCT00665561|143150952|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.44|2.18||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.18|0.44|
71823702|NCT00665561|143150953|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.51|1.59||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.59|0.51|
71823703|NCT00665561|143150954|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.7|1.76||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.76|0.70|
71643768|NCT02635750|142805598|OTHER||Adjusted gMean ratio(%)|113.08|||||TWO_SIDED|90.0|106.41|120.15|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone. (BI 409306+don / don) Intra-individual coefficient of variation (gCV (%)) = 9.0.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||120.15|106.41|
71643769|NCT02635750|142805599|OTHER||Adjusted gMean ratio(%)|100.01|||||TWO_SIDED|90.0|89.549|111.68|||||Ratio of BI 409306 25mg with donepezil 10mg and BI 409306 25mg alone (BI 409306+don/ BI 409306). Intra-individual coefficient of variation (gCV(%)) = 18.6.|The statistical model used for the analysis of those endpoints was an analysis of variance (ANOVA) model on the logarithmic scale (natural logarithm). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the other effect was considered as fixed. Abbreviations used: geometric mean (gMean), donepezil (don)||111.68|89.549|
71643770|NCT02635750|142805600|OTHER||Adjusted gMean ratio(%)|98.38|||||TWO_SIDED|90.0|93.413|103.6|||||Ratio of donepezil 5mg with BI 409306 100mg and donepezil 5mg alone (BI 409306+don / don). Intra-individual coefficient of variation (gCV (%)) = 7.7.|"The PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'periods' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.~Abbreviations used: geometric mean (gMean), donepezil (don)"||103.60|93.413|
71643771|NCT00830258|142805609|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|105.76||||||90.0|98.17|113.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||113.93|98.17|
71643772|NCT00830258|142805610|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.45||||||90.0|104.31|116.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||116.96|104.31|
71643773|NCT00830258|142805611|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.61||||||90.0|104.39|117.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||117.20|104.39|
71643774|NCT05511935|142805643|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|3.69||0.64|TWO_SIDED|95.0|-5.57|9.06|||t-test, 2 sided|||||9.06|-5.57|0.64
71643775|NCT05511935|142805644|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.81||0.47|TWO_SIDED|95.0|-2.28|4.89|||t-test, 2 sided|||||4.89|-2.28|0.47
71643776|NCT05511935|142805645|SUPERIORITY||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|4.25||0.59|TWO_SIDED|95.0|-10.77|6.11|||t-test, 2 sided|||||6.11|-10.77|0.59
71643777|NCT05511935|142805646|SUPERIORITY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|5.53||0.77|TWO_SIDED|95.0|-12.61|9.38|||t-test, 2 sided|||||9.38|-12.61|0.77
71643778|NCT05511935|142805647|SUPERIORITY||Mean Difference (Final Values)|-12.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.95|-6.47|||t-test, 2 sided|||||-6.47|-17.95|<0.001
71643779|NCT05511935|142805648|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|1.87||0.39|TWO_SIDED|95.0|-2.1|5.34|||t-test, 2 sided|||||5.34|-2.10|0.39
71643780|NCT05511935|142805649|SUPERIORITY||Mean Difference (Final Values)|-8.88|STANDARD_ERROR_OF_MEAN|2.84|<|0.01|TWO_SIDED|95.0|-14.52|-3.24|||t-test, 2 sided|||||-3.24|-14.52|<0.01
71643781|NCT05511935|142805650|SUPERIORITY||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.06||0.49|TWO_SIDED|95.0|-10.9|5.23|||t-test, 2 sided|||||5.23|-10.90|0.49
71643782|NCT05511935|142805652|SUPERIORITY||Slope|7.71|STANDARD_ERROR_OF_MEAN|5.28||0.15|TWO_SIDED|95.0|-2.92|18.35|||Regression, Linear|||||18.35|-2.92|0.15
71643783|NCT05511935|142805653|SUPERIORITY||Slope|0.43|STANDARD_ERROR_OF_MEAN|4.19||0.92|TWO_SIDED|95.0|-8.13|8.99|||Regression, Linear|||||8.99|-8.13|0.92
71643784|NCT05511935|142805654|SUPERIORITY||Slope|7.66|STANDARD_ERROR_OF_MEAN|5.81||0.2|TWO_SIDED|95.0|-4.17|19.49|||Regression, Linear|||||19.49|-4.17|0.20
71643785|NCT05511935|142805655|SUPERIORITY||Slope|-9.29|STANDARD_ERROR_OF_MEAN|10.74||0.39|TWO_SIDED|95.0|-31.15|12.56|||Regression, Linear|||||12.56|-31.15|0.39
71643786|NCT05090839|142805663|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|variance explained by the IV.|0.072|||<|0.05|TWO_SIDED|95.0|0.0|0.234|||ANOVA|||||.234|.0000|<0.05
71643787|NCT05090839|142805665|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.358|||<|0.05|TWO_SIDED|95.0|0.0|0.554|||ANOVA|||This is a comparison that is specific to the contrast of visualizing traumatic versus stressful events.||.554|0|<0.05
71643788|NCT05090839|142805666|EQUIVALENCE|The 95% confidence interval is used to assess the difference between the means of the 2 x 2 (English vs. Spanish) and (Trauma vs. Non-trauma) writing groups.|Mean Difference (Final Values)|0.51|||<|0.05|TWO_SIDED|95.0|0.0|0.676|||ANOVA|||||.676|.000|<0.05
71643789|NCT03913377|142805667|EQUIVALENCE|A statistically significant difference in NIBUT/NIKBUT between Test lens and Spectacles was concluded if the upper confidence limit of the 95% CI is below zero or the lower limit is above zero.|LS Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|0.678|||TWO_SIDED|95.0|-4.14|-1.44|||Mixed Model Analysis|Kenward and Roger method was used for denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|The null and alternative hypotheses for testing significant difference between Test lens and Spectacles among habitual lens users with respect to NIBUT/NIKBUT.||-1.44|-4.14|
71643790|NCT03913377|142805668|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|85.59|STANDARD_ERROR_OF_MEAN|1.038|||TWO_SIDED|95.0|43.2|97.89|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||97.89|43.2|
71643791|NCT03913377|142805668|OTHER|Estimated 95% confidence intervals for the point estimates of Test and Control|Mean Proportion|84.17|STANDARD_ERROR_OF_MEAN|0.871|||TWO_SIDED|95.0|48.67|96.75|||Mixed Model Analysis|||Point estimates for Test and Control with 95% confidence intervals||96.75|48.67|
71823704|NCT00665561|143150955|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.25|4.93||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||4.93|0.25|
71823705|NCT00665561|143150956|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.18|2.47||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||2.47|0.18|
71823706|NCT00665561|143150957|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.57|1.08||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.||1.08|0.57|
71823707|NCT00665561|143150958|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.61|0.99||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||0.99|0.61|
71823708|NCT00665561|143150959|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.33||||||All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.33|0.64|
71823709|NCT00665561|143150959|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.32|1.52||||||AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.32|
71823710|NCT00665561|143150959|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.66|
71823711|NCT00665561|143150960|SUPERIORITY||Risk Ratio (RR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.10|0.35|
71823712|NCT00665561|143150961|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.52|0.59|
71823713|NCT00665561|143150962|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.66|1.28||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.||1.28|0.66|
71823714|NCT00665561|143150963|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6225|TWO_SIDED|95.0|0.66|1.28|||Regression, Cox|||||1.28|0.66|0.6225
71823715|NCT02081365|143150964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|95.0|0.74|3.55|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||3.55|.74|<0.05
71823716|NCT02081365|143150965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|||<|0.05|TWO_SIDED|95.0|0.39|1.57|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.57|.39|<0.05
71823717|NCT02081365|143150966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.05|TWO_SIDED|95.0|0.61|1.85|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.85|.61|<0.05
71823718|NCT02081365|143150967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.05|TWO_SIDED|95.0|0.01|1.64|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate||1.64|.01|<0.05
71823719|NCT03230006|143150992|SUPERIORITY||Partial eta squared|0.152||||0.002|TWO_SIDED|95.0|||||ANOVA||A two-way mixed ANOVA was conducted to investigate treatment group differences in change in mean number of drinks consumed from baseline to post-treatment, as indicated by the Time by Treatment Condition interaction effect.|||||0.002
71823720|NCT03230006|143150992|SUPERIORITY||Partial eta squared|0.342|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA||This is the partial eta squared for the main effect of time.|||||<.001
71823721|NCT03230006|143150992|SUPERIORITY||Partial eta squared|0.018||||0.309|TWO_SIDED|95.0|||||ANOVA||This is the partial eta squared for the main effect of treatment condition.|||||.309
71823722|NCT03230006|143150992|OTHER||F|38.92|||<|0.001|TWO_SIDED|95.0||||The threshold for significance is p \<.05.|ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||<.001
71823723|NCT03230006|143150992|OTHER||F|5.43||||0.03|TWO_SIDED|95.0|||||ANOVA|||After conducting the initial two-way mixed ANOVA, follow-up testing was conducted to determine the simple main effects of time (pre to post) on mean number of drinks per week within each treatment condition, which was examined using one-way repeated measures ANOVAs.||||.030
71823724|NCT03230006|143150992|OTHER||F|1.15||||0.016|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at baseline. For the UP, n=51; for the TC, n=24.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.016
71643792|NCT03913377|142805669|OTHER|Estimated 95% confidence intervals for the point estimates of test.|Mean|0.52|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|0.4|0.65|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimate was calculated for Test.|0.65|0.40|
71823725|NCT03230006|143150992|OTHER||F|7.78||||0.007|TWO_SIDED|95.0|||||ANOVA||This is the simple main effect of treatment condition on mean number of drinks consumed per week at post-treatment. For the UP, n=38; for the TC, n=21.|After conducting the initial two-way mixed ANOVA, the simple main effects for treatment condition on mean number of drinks consumed per week at each timepoint (pre and post) were examined using one-way ANOVAs.||||.007
71823726|NCT04949399|143150994|SUPERIORITY||Difference (%)|30.4|||<|0.0001|TWO_SIDED|95.0|23.5|37.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||37.2|23.5|<.0001
71823727|NCT04949399|143150995|SUPERIORITY||Difference (%)|39.8|||<|0.0001|TWO_SIDED|95.0|32.0|47.7||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.7|32.0|<0.0001
71823728|NCT04949399|143150996|SUPERIORITY||Difference (%)|41.6|||<|0.0001|TWO_SIDED|95.0|33.7|49.6||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.6|33.7|<0.0001
71643793|NCT03913377|142805669|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean|0.13|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|95.0|-0.19|0.44|||Mixed Model Analysis|Kenward and Rogers Metod was used for degrees of freedom|||Point estimates were calculated for Control.|0.44|-0.19|
71643794|NCT03913377|142805670|OTHER|Estimated 95% confidence intervals for the point estimates of Test.|Mean Proportion|30.7|STANDARD_ERROR_OF_MEAN|19.87|||TWO_SIDED|95.0|6.5|73.8|||Mixed Model Analysis||Point estimates were calculated for Test|||73.8|6.5|
71643795|NCT03913377|142805670|OTHER|Estimated 95% confidence intervals for the point estimates of Control.|Mean Proportion|27.9|STANDARD_ERROR_OF_MEAN|18.17|||TWO_SIDED|95.0|6.1|69.8|||Mixed Model Analysis||Point estimates were calculated for Control.|||69.8|6.1|
71643796|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.06|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least means squares from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.06
71643797|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.008|TWO_SIDED|||||p\< 0.05 was considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.008
71643798|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|||||p\< 0.05 was considered to be significant.|Mixed Models Analysis|||Comparison of Week 12 mean for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.07
71643799|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means.|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.003|TWO_SIDED|||||p\<0.05 is considered as being significant.|ANOVA|||Comparison of Week 10 mean for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates,||||0.003
71643800|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.4|STANDARD_ERROR_OF_MEAN|1.1||0.0002|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. .||||0.0002
71643801|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-4.1|STANDARD_ERROR_OF_MEAN|1.2||0.0007|TWO_SIDED||||||ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0007
71643802|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.1||0.15|TWO_SIDED|||||p\<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.15
71643803|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.014|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariate values.||||0.014
71643804|NCT00862563|142805755|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.1|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means s from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.1
71643805|NCT00862563|142805756|SUPERIORITY_OR_OTHER||Mean difference Week 12|8.9|STANDARD_ERROR_OF_MEAN|3.6||0.015|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison between mean values obtained for the topiramate and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.015
71643806|NCT00862563|142805756|SUPERIORITY_OR_OTHER||Mean Difference Week 12|0.98|STANDARD_ERROR_OF_MEAN|3.6||0.784|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis.||||0.784
71643807|NCT00862563|142805756|SUPERIORITY_OR_OTHER||Mean difference Week 12|3.65|STANDARD_ERROR_OF_MEAN|3.3||0.264|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis.||||0.264
71643808|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.4|STANDARD_ERROR_OF_MEAN|9.7||0.013|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.013
71660935|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 9||||0.204
71643809|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.9|STANDARD_ERROR_OF_MEAN|9.8||0.036|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.036
71643810|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.8|STANDARD_ERROR_OF_MEAN|9.9||0.24|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.24
71643811|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-33.0|STANDARD_ERROR_OF_MEAN|9.0||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
71643812|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-29.7|STANDARD_ERROR_OF_MEAN|9.2||0.0015|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0015
71643813|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-37.7|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
71643814|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-20.7|STANDARD_ERROR_OF_MEAN|10.0||0.04|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.04
71643815|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-23.3|STANDARD_ERROR_OF_MEAN|10.2||0.025|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.025
71823729|NCT04949399|143150999|SUPERIORITY||Difference (%)|54.8|||<|0.0001|TWO_SIDED|95.0|46.8|62.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||62.8|46.8|<.0001
71823730|NCT04949399|143151000|SUPERIORITY||Difference (%)|39.1|||<|0.0001|TWO_SIDED|95.0|30.5|47.8||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||47.8|30.5|<.0001
71643816|NCT00862563|142805757|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.8|STANDARD_ERROR_OF_MEAN|10.3||0.018|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.018
71643817|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-22.5|STANDARD_ERROR_OF_MEAN|7.8||0.005|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.005
71823731|NCT04949399|143151001|SUPERIORITY||Difference (%)|44.6|||<|0.0001|TWO_SIDED|95.0|36.8|52.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||52.5|36.8|<.0001
71823732|NCT04949399|143151002|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-6.7|-4.7||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.7|-6.7|<.0001
71823733|NCT04949399|143151005|SUPERIORITY||Difference (%)|46.1|||<|0.0001|TWO_SIDED|96.0|38.1|54.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||54.2|38.1|<0.0001
71823734|NCT04949399|143151006|SUPERIORITY||Difference (%)|51.9|||<|0.0001|TWO_SIDED|95.0|43.3|60.5||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||60.5|43.3|<0.0001
71823735|NCT04949399|143151007|SUPERIORITY||Difference (%)|40.1|||<|0.0001|TWO_SIDED|95.0|31.3|49.0||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||49.0|31.3|<0.0001
71823736|NCT04949399|143151008|SUPERIORITY||Difference (%)|45.2|||<|0.0001|TWO_SIDED|95.0|37.1|53.2||P-value derived from Cochran-Mantel-Haenszel (CMH) model stratified by investigator site and baseline C-APPS.|Cochran-Mantel-Haenszel|||||53.2|37.1|<0.0001
71823737|NCT04949399|143151009|SUPERIORITY||Difference (SE)|-5.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.8|-4.6||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||||-4.6|-6.8|<0.0001
71643818|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-24.1|STANDARD_ERROR_OF_MEAN|7.9||0.003|TWO_SIDED||||||ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.003
71643819|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least square means|-16.3|STANDARD_ERROR_OF_MEAN|8.0||0.044|TWO_SIDED|||||p\< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.044
71643820|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-38.1|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates.||||<0.0001
71643821|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-47.6|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||<0.0001
71643822|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-34.0|STANDARD_ERROR_OF_MEAN|9.2||0.0004|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.||||0.0004
71643823|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-19.3|STANDARD_DEVIATION|8.0||0.017|TWO_SIDED|||||p\<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.017
71643824|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-31.2|STANDARD_ERROR_OF_MEAN|8.1||0.0002|TWO_SIDED|||||p\<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.||||0.0002
71643825|NCT00862563|142805758|SUPERIORITY_OR_OTHER||Difference between least squares means|-18.5|STANDARD_ERROR_OF_MEAN|8.2||0.026|TWO_SIDED|||||p\< 0.05 is considered to be significant|ANOVA|||.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates.||||0.026
71643826|NCT00862563|142805759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction term.'||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
71643827|NCT00862563|142805759|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for group x time interaction term for the comparison of data for the topiramate and placebo group.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction.||||<0.0001
71643828|NCT00862563|142805759|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction.||||0.30
71643829|NCT00862563|142805760|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction effect for the paired comparison of COWAT-category data for the zonisamide and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.003
71823738|NCT04949399|143151010|SUPERIORITY||Difference (SE)|-5.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-6.7|-4.5||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 30||-4.5|-6.7|<0.0001
71643830|NCT00862563|142805760|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||p\< 0.01 is considered to be significant.|Mixed Models Analysis|The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction||||0.01
71823739|NCT04949399|143151010|SUPERIORITY||Difference (SE)|-5.0|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-6.0|-3.9||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 60||-3.9|-6.0|<0.0001
71823740|NCT04949399|143151010|SUPERIORITY||Difference (SE)|-3.9|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.9|-2.8||P-value derived from ANCOVA model stratified by investigator site and baseline C-APPS with baseline value as a factor.|ANCOVA|||Day 90||-2.8|-4.9|<0.0001
71823741|NCT01866917|143151111|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||.574
71823742|NCT01866917|143151112|SUPERIORITY|Statistical analysis performed using SPSS software, version 15 (SPSS Inc., Chicago, IL). Data for quantitative variables reported as a median and interquartile range. The Mann Whitney and chi-square tests were used for the analysis of continuous and categorical variables.|Interquartile range (IQR)|3.0||||0.825|TWO_SIDED|||||Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.|Chi-squared|||TAP has been demonstrated to have a potential role in reducing pain, post-operative opioid requirement, and time to hospital discharge after abdominal hysterectomies and cesarean sections.||||.825
71823743|NCT00662909|143151122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.026|TWO_SIDED|95.0|-0.66|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.03|-0.66|0.026
71823744|NCT00662909|143151122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.82|-0.18||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.18|-0.82|<0.001
71823745|NCT00662909|143151123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.98|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.98|0.001
71823746|NCT00662909|143151123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.07|-0.33||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.33|-1.07|<0.001
71823747|NCT00662909|143151124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.1||||0.001|TWO_SIDED|95.0|4.4|17.9||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.9|4.4|0.001
71823748|NCT00662909|143151124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0||||0.002|TWO_SIDED|95.0|4.2|17.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||17.7|4.2|0.002
71823749|NCT00662909|143151125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48||||0.003|TWO_SIDED|95.0|-0.8|-0.15||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.15|-0.80|0.003
71643831|NCT00862563|142805760|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction||||0.36
71643832|NCT00862563|142805761|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value is for the group x time interaction effect||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.07
71643833|NCT00862563|142805761|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group X time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||<0.0001
71643834|NCT00862563|142805761|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.95
71643835|NCT00862563|142805762|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Spatial Span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.||||0.038
71643836|NCT00862563|142805762|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||p\<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.||||0.0025
71643837|NCT00862563|142805762|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||p\<0.01 is considered to be significant|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.||||0.3
71643838|NCT00824291|142805793|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.12||||0.002|TWO_SIDED|95.0|0.78|3.46|||ANCOVA|||||3.46|0.78|0.002
71643839|NCT00824291|142805794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.33||||0.067|TWO_SIDED|95.0|-0.09|2.76|||ANCOVA|||||2.76|-0.09|0.067
71643840|NCT00824291|142805795|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71643841|NCT00824291|142805796|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
71643842|NCT00824291|142805797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.04|TWO_SIDED|95.0|0.01|0.44|||ANCOVA|||||0.44|0.01|0.040
71643843|NCT00824291|142805798|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26||||0.035|TWO_SIDED|95.0|0.16|4.37|||ANCOVA|||||4.37|0.16|0.035
71643844|NCT00824291|142805799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.041|TWO_SIDED|95.0|0.1|4.78|||ANCOVA|||||4.78|0.10|0.041
71643845|NCT00824291|142805800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.145|TWO_SIDED|95.0|-0.13|0.91|||ANCOVA|||||0.91|-0.13|0.145
71643846|NCT00840216|142805852|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|106.9||||||90.0|||||||Bioequivalence is established when the ratio of the mean falls within 80-125.|||||
71643847|NCT00840216|142805853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
71643848|NCT00840216|142805854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.|||||
71643849|NCT01642277|142805859|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.94||||0.052|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For symptom-severity score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size and non-normal distributions of symptom severity scores. The null hypothesis is that there is no difference between the two groups in symptom severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) symptom severity than the other group.||||.052
71643850|NCT01642277|142805859|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.06||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group.||||.04
71643851|NCT01642277|142805859|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.176||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group.||||.03
71660936|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.119||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.119
71643852|NCT01642277|142805859|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.9||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group.||||.37
71643853|NCT01642277|142805859|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.02||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group.||||.04
71643854|NCT01642277|142805859|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|2.03||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group.||||.04
71643855|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.74||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the obstructive discomfort score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in obstructive discomfort, and and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) obstructive discomfort than the other group.||||.46
71643856|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.8||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group.||||.07
71643857|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.59||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group.||||.11
71643858|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.69||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group.||||.09
71643859|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.68||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group.||||.09
71643860|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-0.23||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group.||||.82
71643861|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.92||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group.||||.06
71643862|NCT01642277|142805860|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-1.85||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group.||||.07
71643863|NCT03364192|142805877|OTHER|Multilevel modeling adapted for multiple-baseline design comparing participant goal attainment before, during, and after peer-delivered Whole Health Coaching.|||||<|0.05|||||||Multilevel Modeling|||||||<0.05
71643864|NCT03317444|142805881|SUPERIORITY||Treatment difference in % of subjects|36.7|||<|0.0001|TWO_SIDED|95.0|23.5|48.9|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||48.9|23.5|< 0.0001
71643865|NCT03317444|142805881|SUPERIORITY||Treatment difference in % of subjects|34.5|||<|0.0001|TWO_SIDED|95.0|21.2|46.8|||Fisher Exact|||% Subjects with ≥ 4 mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||46.8|21.2|< 0.0001
71823750|NCT00662909|143151125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.79|-0.13||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.13|-0.79|<0.001
71823751|NCT00662909|143151126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.022|TWO_SIDED|95.0|-0.77|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.77|0.022
71823752|NCT00662909|143151126|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.24|-0.96|0.001
71823753|NCT02390557|143151160|SUPERIORITY||Mean Difference (Final Values)|10.7||||0.074|TWO_SIDED||||||Chi-squared, Corrected|||we had a prior hypothesis that the survey intervention would be associated with a larger increase in perceived quality of health care compared with control from Wave 1 to Wave 2||||0.074
71823754|NCT02390557|143151160|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.069|TWO_SIDED||||||Chi-squared, Corrected|||We compared change in perception of quality of health care between Control v YES Health, wave 1 v Wave 2||||.069
71823755|NCT01360840|143151171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||||TWO_SIDED|95.0|0.57|1.39||||||||1.39|0.57|
71823756|NCT01360840|143151171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.26||||||||1.26|0.52|
71823757|NCT01360840|143151172|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.52|2.31||||||||2.31|0.52|
71823758|NCT01360840|143151172|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.47|2.15||||||||2.15|0.47|
71823759|NCT01360840|143151173|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91|||||TWO_SIDED|95.0|0.58|1.44||||||||1.44|0.58|
71823760|NCT01360840|143151173|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.52|1.27||||||||1.27|0.52|
71823761|NCT00293462|143151193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0|||||Fisher Exact|Two by two table was used. One cell had expected frequency test less than five, so Fisher's exact two-tailed test was used.||Fisher's exact two tailed test||||0.09
71823762|NCT00293462|143151194|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED|95.0|||||Mantel Haenszel|Log rank, Breslow, Tarone-Ware test, but used mantel cox log rank for this analysis||Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SS, and SG. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used||||0.92
71823763|NCT00293462|143151195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0||||0.28 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||Multilevel regression was used.||||0.28
71823764|NCT00293462|143151196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||0.78 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.78
71823765|NCT00293462|143151197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||0.22 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||||||0.22
71823766|NCT01950260|143151226|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
71823767|NCT01950260|143151227|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
71823768|NCT01950260|143151228|SUPERIORITY|||||||0.33|||||||Regression, Linear|||||||0.33
71823769|NCT03283553|143151229|SUPERIORITY|||||||0.264||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.264
71823770|NCT03283553|143151230|SUPERIORITY|||||||0.555||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.555
71886194|NCT00662792|143292991|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9978|TWO_SIDED|95.0|-0.05|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|24 hours||0.05|-0.05|0.9978
71643866|NCT03317444|142805881|SUPERIORITY||Treatment difference in % of subjects|33.1|||<|0.0001|TWO_SIDED|95.0|19.7|45.6|||Fisher Exact|||% Subjects with Serum Bicarbonate in the Normal Range (22 - 29 mEq/L): TRC101-Placebo||45.6|19.7|< 0.0001
71643867|NCT03317444|142805882|SUPERIORITY||Treatment difference in LS means|2.63|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|1.77|3.5|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares (LS) Mean Change from Baseline: TRC101-Placebo||3.5|1.77|< 0.0001
71643868|NCT02944617|142805884|OTHER|||||||1|||||||Fisher Exact|||||||1.00
71643869|NCT02944617|142805886|OTHER|||||||0.077|||||||Log Rank|||||||0.077
71643870|NCT05133180|142805890|SUPERIORITY|The following null hypothesis is defined on this endpoint: the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Odds Ratio (OR)|16.946|||<|0.001|TWO_SIDED|95.0|3.412|84.165||P-value of treatment variable from logistic regression model on the number of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min|Regression, Logistic|||It was analyzed by means of a logistic regression model adjusting by pre-defined baseline factors (treatment, gender, age class, baseline Schirmer I test value as fixed effects and site as random effect). For the imputation of missing data at week 4, a Multiple Imputation approach is adopted by performing a regression model with the baseline Schirmer I test value, gender, age class, and Schirmer I test at week 2 as explanatory variables and generating 200 datasets.||84.165|3.412|<0.001
71643871|NCT05133180|142805891|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|adjusted mean difference|-4.561||||0.322|TWO_SIDED|95.0|-13.581|4.459||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||This endpoint was analyzed by means of an Analysis of Covariance with change from baseline in global SANDE Score at Week 12 as dependent variable, treatment, gender, age class, baseline global SANDE score as fixed effects and site as random effect. For missing data, Multiple Imputation approach is adopted by performing a regression model with the baseline global SANDE score, gender, age class, and intermediate global SANDE scores up to week 12 as explanatory variables and generating 200 datasets||4.459|-13.581|0.322
71643872|NCT05133180|142805892|SUPERIORITY|Analysis was based on a logistic regression with the number of patients reaching a value of Schirmer I test \>10mm/5min at week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|15.95|||<|0.001|TWO_SIDED|95.0|3.091|82.31|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with the number of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||82.310|3.091|<0.001
71643873|NCT05133180|142805893|SUPERIORITY||adjusted mean difference|-2.753||||0.572|TWO_SIDED|95.0|-12.303|6.798||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||6.798|-12.303|0.572
71643874|NCT05133180|142805894|SUPERIORITY||adjusted mean difference|-4.732||||0.307|TWO_SIDED|95.0|-13.819|4.354||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA regression model|||This endpoint was analyzed by means of an ANCOVA adjusting by pre-defined baseline factors (treatment, gender, age class, baseline SANDE score for severity as fixed effects and site as random effect).||4.354|-13.819|0.307
71643875|NCT05133180|142805895|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.16||||0.468|TWO_SIDED|95.0|-3.668|7.988||P-value of Least Square (LS) means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|MMRM|||Impact on daily activities at week 4.||7.988|-3.668|0.468
71643876|NCT05133180|142805895|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.431||||0.492|TWO_SIDED|95.0|-4.5|9.362||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 4.|MMRM|||Emotional Impact due to Dry eye at week 4.||9.362|-4.500|0.492
71643877|NCT05133180|142805895|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|3.3||||0.51|TWO_SIDED|95.0|-6.511|13.111||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 4.|MMRM|||Impact on Work due to Dry Eye at week 4.||13.111|-6.511|0.510
71823771|NCT03283553|143151231|SUPERIORITY|||||||0.619||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.619
71823772|NCT03283553|143151232|SUPERIORITY|||||||0.532||||||P-value represents interaction for differential changes between time point (9 months compared to baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Complete illness understanding at 9 months was compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.532
71823773|NCT03283553|143151233|SUPERIORITY|||||||0.108||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Satisfaction with cancer care at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.108
71823774|NCT03283553|143151234|SUPERIORITY|||||||0.405||||||P-value represents interaction for differential changes between time point (9 months vs baseline) and group assignment.|Regression, Logistic|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Symptoms of anxiety at 9 months were compared to baseline using logistic regression models estimated with generalized estimating equations (GEE) and an exchangeable correlation specification. Each model included group assignment, time (9 months versus baseline), their interaction, and covariates.||||0.405
71823775|NCT03283553|143151235|SUPERIORITY|||||||0.412||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.412
71823776|NCT03283553|143151236|SUPERIORITY|||||||0.872||||||P-value represents the significance of the term for group assignment.|Regression, Linear|Adjusts for baseline patient education, care partner gender, and patient disease stage.||Quality of communication at 9 months was compared to baseline using linear regression models with the difference in the score as the outcome and a term for group assignment as the main independent variable.||||0.872
71823777|NCT03283553|143151237|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who were registered during the 9-month follow up period.||||||<0.001
71823778|NCT03283553|143151238|SUPERIORITY|||||||0.003|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||0.003
71823779|NCT03283553|143151239|SUPERIORITY||||||<|0.001|||||||Fisher Exact|P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.||||||<0.001
71823780|NCT03283553|143151240|SUPERIORITY|||||||0.128||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.128
71823781|NCT03283553|143151241|SUPERIORITY|||||||0.247||||||P-value assess between-group differences in proportion of participants who used a patient portal feature at least once during 9-month follow up.|Fisher Exact|||||||0.247
71823782|NCT03686683|143151242|SUPERIORITY||Odds Ratio (OR)|1.16||||0.4586|TWO_SIDED|95.0|0.78|1.74|||Cochran-Mantel-Haenszel|||||1.74|0.78|0.4586
71823783|NCT00372060|143151247|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001||95.0|-1.0|-0.6|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline HbA1c.||||-0.6|-1.0|<0.001
71823784|NCT00372060|143151248|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001||95.0|-23.4|-10.0|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline fasting plasma glucose.||||-10.0|-23.4|<0.001
71823785|NCT00372060|143151249|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-49.2|STANDARD_ERROR_OF_MEAN|7.7|<|0.001||95.0|-64.5|-33.9|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline 2-hour postprandial glucose.||||-33.9|-64.5|<0.001
71823786|NCT01579578|143151251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|12.23||0.688|TWO_SIDED|95.0|-30.81|20.81||two sided p value|ANCOVA|ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.|the difference in LS means is estimated|60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)||20.81|-30.81|0.688
71823787|NCT00714233|143151261|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Paired t-test to analyze BMI at baseline and 24 weeks||||<0.05
71823788|NCT01813422|143151280|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-1.007|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.375|-0.64|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.|Treatment difference uses placebo as the reference.|||-0.640|-1.375|< 0.0001
71823789|NCT01813422|143151281|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-4.889|STANDARD_ERROR_OF_MEAN|1.201|<|0.0001|TWO_SIDED|95.0|-7.247|-2.531|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.|Treatment difference uses placebo as the reference.|||-2.531|-7.247|< 0.0001
71823790|NCT01813422|143151282|SUPERIORITY_OR_OTHER||Treatment Difference|17.0|||<|0.0001|TWO_SIDED|95.0|10.3|23.5|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||23.5|10.3|< 0.0001
71823791|NCT01813422|143151283|SUPERIORITY_OR_OTHER||Treatment Difference|12.5||||0.0002|TWO_SIDED|95.0|5.8|19.1|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.|||19.1|5.8|0.0002
71823792|NCT04889118|143151292|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.55||||0.0013|TWO_SIDED|95.0|0.37|0.81||One-sided p-value based on log-rank test.|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||0.81|0.37|0.0013
71823793|NCT04889118|143151293|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|Hazard Ratio (HR)|0.93||||0.3728|TWO_SIDED|95.0|0.58|1.48||One-sided p-value based on log-rank test|Log Rank||HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.58|0.3728
71643878|NCT05133180|142805895|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|Least square mean difference|4.078||||0.268|TWO_SIDED|95.0|-3.142|11.299||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|MMRM|||Quality of life - Impact on daily activities - Week 12||11.299|-3.142|0.268
71643879|NCT05133180|142805895|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall"|least square mean difference|5.55||||0.227|TWO_SIDED|95.0|-3.462|14.562||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Emotional Impact) at Week 12.|MMRM|||Quality of life - Emotional Impact due to Dry eye - Week 12||14.562|-3.462|0.227
71643880|NCT05133180|142805895|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|3.475||||0.501|TWO_SIDED|95.0|-6.651|13.601||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Impact on Work) at Week 12.|MMRM|||Quality of life - Impact on Work due to Dry Eye - Week 12||13.601|-6.651|0.501
71643881|NCT05133180|142805896|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.549||||0.924|TWO_SIDED|95.0|-11.82|10.723||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module Satisfaction with Treatment Effectiveness - week 4||10.723|-11.820|0.924
71643882|NCT05133180|142805896|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|1.072||||0.745|TWO_SIDED|95.0|-5.398|7.542||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 4.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 4||7.542|-5.398|0.745
71643883|NCT05133180|142805896|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-4.206||||0.467|TWO_SIDED|95.0|-15.53|7.118||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Satisfaction with Treatment Effectiveness - week 12||7.118|-15.530|0.467
71643884|NCT05133180|142805896|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|2.244||||0.564|TWO_SIDED|95.0|-5.387|9.874||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Treatment Satisfaction \& Bother module (Treatment- Related Bother / Inconvenience) at Week 12.|MMRM|||IDEEL Treatment satisfaction \& Bother Module - Treatment- Related Bother / Inconvenience - week 12||9.874|-5.387|0.564
71643885|NCT05133180|142805897|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-0.805||||0.802|TWO_SIDED|95.0|-7.086|5.476||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 4.|MMRM|||IDEEL - Symptom Bother module - week 4||5.476|-7.086|0.802
71643886|NCT05133180|142805897|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID was provided using least square means at each visit and overall."|least square mean difference|-8.789||||0.019|TWO_SIDED|95.0|-16.16|-1.418||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Symptom Bother Module at Week 12.|MMRM|||IDEEL - Symptom Bother module - week 12||-1.418|-16.160|0.019
71643887|NCT05133180|142805898|SUPERIORITY||least square mean difference|-1.518||||0.045|TWO_SIDED|95.0|-3.005|-0.031||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 4.|MMRM|||Herein Week 4 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.031|-3.005|0.045
71643888|NCT05133180|142805898|SUPERIORITY||least square mean difference|-1.773||||0.038|TWO_SIDED|95.0|-3.446|-0.101||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 8.|MMRM|||Herein Week 8 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||-0.101|-3.446|0.038
71643889|NCT05133180|142805898|SUPERIORITY||least square mean difference|-1.224||||0.2|TWO_SIDED|95.0|-3.096|0.649||P-value of LS means difference between treatments from the MMRM on change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale at Week 12|MMRM|||Herein Week 12 was considered. The change from baseline in Cornea and conjunctiva vital staining with fluorescein NEI scale was analyzed by means of an MMRM adjusting by pre-defined factors (gender, age class, NEI scale baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||0.649|-3.096|0.200
71643890|NCT05133180|142805899|SUPERIORITY||least square mean difference|1.64||||0.016|TWO_SIDED|95.0|0.3|2.98||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 4.|MMRM|||Herein week 4 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.980|0.300|0.016
71643891|NCT05133180|142805899|SUPERIORITY||least ssquare mean difference|1.133||||0.129|TWO_SIDED|95.0|-0.329|2.596||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 8.|MMRM|||Herein week 8 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.596|-0.329|0.129
71643892|NCT05133180|142805899|SUPERIORITY||least square mean difference|1.36||||0.05|TWO_SIDED|95.0|-0.002|2.722||P-value of LS means difference between treatments from the MMRM on change from baseline in TFBUT at Week 12.|MMRM|||Herein week 12 was considered. The change from baseline in TFBUT values was analyzed by means of a MMRM adjusting by pre-defined factors (gender, age class, TFBUT baseline value, treatment, visit, and treatment by visit interaction; subject was considered as a random effect).||2.722|-0.002|0.050
71643893|NCT05133180|142805900|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 4 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||<0.001
71643894|NCT05133180|142805900|SUPERIORITY|||||||0.009||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.009
71643895|NCT05133180|142805900|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.020
71660937|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.925||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.925
71823794|NCT01454362|143151318|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71823795|NCT01454362|143151319|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71823796|NCT01454362|143151320|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71823797|NCT01454362|143151321|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71823798|NCT01454362|143151322|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71823799|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0464|TWO_SIDED|95.0|-0.98|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.98|0.0464
71823800|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.17|-1.13|0.0080
71823801|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.0159|TWO_SIDED|95.0|-1.08|-0.11|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.11|-1.08|0.0159
71643896|NCT05133180|142805900|SUPERIORITY|||||||0.022||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.022
71643897|NCT05133180|142805901|SUPERIORITY|||||||0.065||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.065
71643898|NCT05133180|142805902|SUPERIORITY|||||||0.125||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.125
71643899|NCT05133180|142805903|SUPERIORITY|||||||0.005||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.005
71643900|NCT05133180|142805903|SUPERIORITY|||||||0.116||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.116
71643901|NCT05133180|142805903|SUPERIORITY|||||||0.864||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.864
71643902|NCT05133180|142805904|SUPERIORITY|||||||0.011||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.011
71643903|NCT05133180|142805904|SUPERIORITY|||||||0.316||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.316
71643904|NCT05133180|142805904|SUPERIORITY|||||||0.685||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.685
71643905|NCT05133180|142805905|SUPERIORITY|||||||0.016||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 8 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.016
71643906|NCT05133180|142805905|SUPERIORITY|||||||0.16||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants|Wilcoxon (Mann-Whitney)|||Herein Week 12 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.160
71643907|NCT05133180|142805905|SUPERIORITY|||||||0.839||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||Herein Week 16 was considered. Change from baseline between the two treatment groups was compared using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption not met.||||0.839
71643908|NCT05133180|142805906|SUPERIORITY|||||||0.0455|||||||Chi-squared|||||||0.0455
71643909|NCT05133180|142805907|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.06||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 8||||0.060
71643910|NCT05133180|142805907|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.079||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 8||||0.079
71643911|NCT05133180|142805907|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.251||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 8||||0.251
71643912|NCT05133180|142805907|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.203||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on daily activities - Week 16||||0.203
71643913|NCT05133180|142805907|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.114||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Emotional impact due to Dry eye - Week 16||||0.114
71643914|NCT05133180|142805907|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.112||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||Quality of life - Impact on work due to Dry Eye - Week 16||||0.112
71643915|NCT05133180|142805908|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.002||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 8||||0.002
71643916|NCT05133180|142805908|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||Symptom bother module - Week 16||||0.076
71643917|NCT05133180|142805909|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.16||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 8||||0.160
71643918|NCT05133180|142805909|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.009||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 8||||0.009
71643919|NCT05133180|142805909|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.076||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants|t-test, 2 sided|||IDEEL - Satisfaction with Treatment Effectiveness - Week 16||||0.076
71643920|NCT05133180|142805909|SUPERIORITY|Changes from baseline in each IDEEL modules scale score was analyzed by comparing the two treatment groups using a two-sample t-test or a Mann-Whitney-Wilcoxon (Wilson rank sum) test if normality assumption was not met.||||||0.128||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all participants.|t-test, 2 sided|||IDEEL - Treatment- Related Bother / Inconvenience - Week 16||||0.128
71643921|NCT03930732|142805955|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and a few secondary endpoint analyses at a 2-sided significance level of 0.049. Testing was then performed sequentially in the order the endpoints are reported (till OM 9). The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.049 level.|Risk Difference (RD)|-0.324||||0.0005|TWO_SIDED|95.0|-0.508|-0.14|||Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), inhaled corticosteroid (ICS) dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.140|-0.508|0.0005
71643922|NCT03930732|142805956|SUPERIORITY||Least Square (LS) Mean Difference|0.083|||<|0.0001|TWO_SIDED|95.0|0.042|0.125||Threshold for significance at 0.049 level.|MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.125|0.042|<0.0001
71643923|NCT03930732|142805957|SUPERIORITY||LS Mean Difference|0.083||||0.0003|TWO_SIDED|95.0|0.038|0.128||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BDFEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.128|0.038|0.0003
71643924|NCT03930732|142805958|SUPERIORITY||LS Mean Difference|0.124||||0.0022|TWO_SIDED|95.0|0.045|0.203||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.203|0.045|0.0022
71643925|NCT03930732|142805959|SUPERIORITY||LS Mean Difference|0.127||||0.0034|TWO_SIDED|95.0|0.042|0.212||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in pre-BD FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-BD FEV1, and FEV1 baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||0.212|0.042|0.0034
71643926|NCT03930732|142805960|SUPERIORITY||LS Mean Difference|-3.363||||0.0017|TWO_SIDED|95.0|-5.459|-1.266||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.266|-5.459|0.0017
71643927|NCT03930732|142805961|SUPERIORITY||Odds Ratio (OR)|1.439||||0.0089|TWO_SIDED|95.0|1.096|1.89||Threshold for significance at 0.049 level.|Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.890|1.096|0.0089
71643928|NCT03930732|142805962|SUPERIORITY||LS Mean Difference|-1.137||||0.0012|TWO_SIDED|95.0|-1.823|-0.45||Threshold for significance at 0.049 level.|MMRM model|||Derived from MMRM model with the change from baseline in E-RS: COPD RS-Total Score to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline E-RS: COPD RS-Total Score, and baseline E-RS: COPD RS-Total Score-by-visit interaction as covariates. Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.450|-1.823|0.0012
71643929|NCT03930732|142805963|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|Risk Difference (RD)|-0.418||||0.0052|TWO_SIDED|95.0|-0.728|-0.109||Threshold for significance at 0.049 level.|Negative binomial model||Derived using delta method.|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.109|-0.728|0.0052
71643930|NCT04708028|142805980|SUPERIORITY|||||||0.379|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.379
71643931|NCT04708028|142805980|SUPERIORITY|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.646
71643932|NCT04708028|142805980|SUPERIORITY|||||||0.219|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.219
71643933|NCT04708028|142805980|SUPERIORITY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.223
71643934|NCT04708028|142805981|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.410
71643935|NCT04708028|142805981|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||8 minutes Post intervention (Dog exposure or no dog exposure)||||0.127
71643936|NCT04708028|142805981|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||8 minutes after starting dental procedure||||0.268
71643937|NCT04708028|142805981|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||8 minutes after completion of dental procedure||||0.353
71643938|NCT02699463|142805982|SUPERIORITY||||||<|0.01||||||The calculated p-value was \<0.01|ANCOVA|||||||<0.01
71643939|NCT01108445|142805983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.157|TWO_SIDED||||||Log Rank|||||||0.157
71643940|NCT01108445|142805985|SUPERIORITY_OR_OTHER||Median PFS|5.6|||||TWO_SIDED||||||||The 95% CI for the HC was (4,6). If the median PFS for RAD001 is within the 95% CI for the HC, it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for RAD001 arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
71643941|NCT01108445|142805985|SUPERIORITY_OR_OTHER||Median PFS|8.3|||||TWO_SIDED||||||||95% CI for HC was(4,6). If the median PFS for Sunitinib is within the 95% CI for the HC,it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for Sunitinib arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.||||
71643942|NCT01108445|142805987|SUPERIORITY_OR_OTHER|||||||0.589|TWO_SIDED||||||Chi-squared|||||||0.589
71643943|NCT01108445|142805988|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||||||0.066
71643944|NCT04188392|142806000|OTHER|Rate of subjects enrolled per month of recruitment; based on 6 subjects enrolled over 5.8 months of recruitment.|Rate (per month)|1.03|||||TWO_SIDED|95.0|0.38|2.25|||||Based on 6 subjects enrolled over 5.8 months of recruitment|Recruitment goal of 6 subjects total.||2.25|0.38|
71643945|NCT04188392|142806001|OTHER|Total participants = 6; completed protocol: yes = 6, no = 0|Point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate = 100% (95% C.I. 54%,100%)|Binary outcome (completed protocol yes vs. no); goal of 75% of subjects completing protocol|Point estimate of completion rate and 95% confidence interval|1|0.54|
71643946|NCT04188392|142806002|OTHER|paired t-test|Mean of the differences|21.7||||0.2873|TWO_SIDED|95.0|-27.4|70.8||A priori significance threshold of p\<0.05|t-test, 2 sided|t=1.2263, df=4||alternative hypothesis: true difference in means is not equal to 0||70.8|-27.4|0.2873
71643947|NCT04188392|142806003|OTHER|Total participants = 6; discontinued due to adverse effects: yes = 0, no =6|Point estimate, 95% confidence interval|0.0|||||TWO_SIDED|95.0|0.0|0.46|||||Discontinuation rates due to adverse effects: Point estimate 0% (95% C.I. 0%, 45.9%)|Binary outcome: Discontinued due to adverse effects yes vs. no||0.46|0|
71643948|NCT04188392|142806004|OTHER|Total participants = 6; completed sleep study 1: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 1 = 100% (95% C.I. 54%, 100%)|Binary outcome: Completed sleep study 1 yes vs. no||1|0.54|
71643949|NCT04188392|142806004|OTHER|Total participants = 6; completed sleep study 2: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for sleep study 2 = 100% (95% C.I. 54%, 100%)|Binary outcome: completed sleep study 2 yes vs. no||1|0.54|
71823802|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.29||0.2563|TWO_SIDED|95.0|-0.89|0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.24|-0.89|0.2563
71643950|NCT04188392|142806004|OTHER|Total participants = 6; completed sleep study 3: yes = 5, no=1|point estimate|0.83|||||TWO_SIDED|95.0|0.36|0.996|||||Point estimate of completion rate for sleep study 3 = 83.3% (95% C.I. 36%, 99.6%)|Binary outcome: completed sleep study 3 yes vs. no||0.996|0.36|
71643951|NCT04188392|142806004|OTHER|Total participants = 6; at least 4 days of actigraphy data: yes = 6, no=0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of completion rate for at least 4 days of actigraphy pre-treatment = 100% (95% C.I. 54%, 100%).|Binary outcome: at least 4 days of actigraphy data pre-treatment yes vs. no||1|0.54|
71643952|NCT04188392|142806004|OTHER|Total participants = 6; at least 4 days of actigraphy post-treatment: yes = 6, no =0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of actigraphy post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of actigraphy post-treatment yes vs. no||1|0.54|
71643953|NCT04188392|142806004|OTHER|Total participants = 6; at least 4 days of sleep diary pre-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary pre-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary pre-treatment yes vs. no||1|0.54|
71643954|NCT04188392|142806004|OTHER|Total participants = 6; at least 4 days of sleep diary post-treatment: yes = 6, no = 0|point estimate|1.0|||||TWO_SIDED|95.0|0.54|1.0|||||Point estimate of at least 4 days of sleep diary post-treatment = 100% (95% C.I. 54%, 100%)|Binary outcome: at least 4 days of sleep diary post-treatment yes vs. no||1|0.54|
71643955|NCT00835692|142806017|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Mean x 100|98.4||||||90.0|91.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|91.5|
71643956|NCT00835692|142806018|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.6|97.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.6|89.6|
71823803|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.0239|TWO_SIDED|95.0|-1.21|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-1.21|0.0239
71823804|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.028|TWO_SIDED|95.0|-1.19|-0.07|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.07|-1.19|0.0280
71823805|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6904|TWO_SIDED|95.0|-0.7|0.46|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.46|-0.70|0.6904
71643957|NCT00835692|142806019|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.5|97.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.7|89.5|
71643958|NCT01149733|142806020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|97.9|||||TWO_SIDED|90.0|91.0|105.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||105.32|91.00|
71823806|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.4022|TWO_SIDED|95.0|-0.83|0.33|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.33|-0.83|0.4022
71823807|NCT00797225|143151324|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.29||0.0451|TWO_SIDED|95.0|-1.17|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-1.17|0.0451
71823808|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.48||0.0007|TWO_SIDED|95.0|-2.56|-0.69|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.69|-2.56|0.0007
71643959|NCT01149733|142806021|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|91.81|||||TWO_SIDED|90.0|87.72|96.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||96.10|87.72|
71643960|NCT01149733|142806022|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|90.64|||||TWO_SIDED|90.0|86.59|94.89|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||94.89|86.59|
71643961|NCT03503318|142806077|OTHER||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.109|0.367||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.367|0.109|<0.0001
71643962|NCT03503318|142806077|OTHER||Hazard Ratio (HR)|0.375|||<|0.0001|TWO_SIDED|95.0|0.227|0.618||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using the stratified Cox proportional hazard model, with treatment (placebo, TV-46000 q1m and TV-46000 q2m or placebo and TV-46000 overall \[including q1m and q2m\]) as explanatory variable and sex-dose as a stratification factor, and the stratified log rank test p-value (sex-dose as a stratification factor) referred to (TV-46000/placebo) comparison.||0.618|0.227|<0.0001
71643963|NCT00834873|142806107|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.77||||||90.0|85.04|105.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.61|85.04|
71643964|NCT00834873|142806108|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.59|102.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.23|90.59|
71643965|NCT00834873|142806109|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.11||||||90.0|90.45|102.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.12|90.45|
71643966|NCT00835705|142806159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.03||||||90.0|98.4|107.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.88|98.40|
71643967|NCT00835705|142806160|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.43||||||90.0|96.71|100.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.18|96.71|
71643968|NCT00835705|142806161|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.29||||||90.0|96.58|100.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.03|96.58|
71643969|NCT00835705|142806162|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.16||||||90.0|95.33|111.64|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||111.64|95.33|
71643970|NCT00835705|142806163|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.79||||||90.0|95.75|112.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.50|95.75|
71643971|NCT00835705|142806164|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|104.26||||||90.0|95.76|113.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||113.52|95.76|
71643972|NCT01750294|142806165|SUPERIORITY_OR_OTHER|||||||0.01||||||a = 0.05|Mixed Models Analysis|||||||0.01
71643973|NCT01592240|142806247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.28|||<|0.001|TWO_SIDED|95.0|-45.06|-23.5|||Mixed models repeated measures analysis|||||-23.50|-45.06|<0.001
71823809|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.47||0.0006|TWO_SIDED|95.0|-2.56|-0.7|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.70|-2.56|0.0006
71643974|NCT01592240|142806247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-45.07|||<|0.001|TWO_SIDED|95.0|-55.93|-34.21|||Mixed models repeated measures analysis|||||-34.21|-55.93|<0.001
71643975|NCT01592240|142806247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.42|||<|0.001|TWO_SIDED|95.0|-64.14|-42.7|||Mixed models repeated measures analysis|||||-42.70|-64.14|<0.001
71643976|NCT01592240|142806247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.58|||<|0.001|TWO_SIDED|95.0|-40.49|-14.67|||Mixed models repeated measures analysis|||||-14.67|-40.49|<0.001
71643977|NCT01592240|142806247|SUPERIORITY_OR_OTHER||Adjusted mean difference|-44.85|||<|0.001|TWO_SIDED|95.0|-57.65|-32.05|||Mixed models repeated measures analysis|||||-32.05|-57.65|<0.001
71643978|NCT01592240|142806248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.41|||<|0.001|TWO_SIDED|95.0|-39.15|-17.67|||Mixed models repeated measures analysis|||||-17.67|-39.15|<0.001
71643979|NCT01592240|142806248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-43.21|||<|0.001|TWO_SIDED|95.0|-53.9|-32.51|||Mixed models repeated measures analysis|||||-32.51|-53.90|<0.001
71643980|NCT01592240|142806248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.03|||<|0.001|TWO_SIDED|95.0|-51.66|-30.41|||Mixed models repeated measures analysis|||||-30.41|-51.66|<0.001
71643981|NCT01592240|142806248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.77|||<|0.001|TWO_SIDED|95.0|-33.7|-13.84|||Mixed models repeated measures analysis|||||-13.84|-33.70|<0.001
71643982|NCT01592240|142806248|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.36|||<|0.001|TWO_SIDED|95.0|-40.24|-20.49|||Mixed models repeated measures analysis|||||-20.49|-40.24|<0.001
71643983|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.0|||<|0.001|TWO_SIDED|95.0|-44.91|-25.1|||Mixed models repeated measures analysis|||Week 12||-25.10|-44.91|<0.001
71643984|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-42.32|||<|0.001|TWO_SIDED|95.0|-52.3|-32.33|||Mixed models repeated measures analysis|||Week 12||-32.33|-52.30|<0.001
71643985|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-53.12|||<|0.001|TWO_SIDED|95.0|-62.97|-43.27|||Mixed models repeated measures analysis|||Week 12||-43.27|-62.97|<0.001
71643986|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-26.96|||<|0.001|TWO_SIDED|95.0|-38.25|-15.67|||Mixed models repeated measures analysis|||Week 12||-15.67|-38.25|<0.001
71643987|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-41.13|||<|0.001|TWO_SIDED|95.0|-52.32|-29.94|||Mixed models repeated measures analysis|||Week 12||-29.94|-52.32|<0.001
71643988|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.09|||<|0.001|TWO_SIDED|95.0|-38.42|-19.77|||Mixed models repeated measures analysis|||Week 24||-19.77|-38.42|<0.001
71643989|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-40.14|||<|0.001|TWO_SIDED|95.0|-49.43|-30.86|||Mixed models repeated measures analysis|||Week 24||-30.86|-49.43|<0.001
71643990|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-39.16|||<|0.001|TWO_SIDED|95.0|-48.37|-29.94|||Mixed models repeated measures analysis|||Week 24||-29.94|-48.37|<0.001
71643991|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.79|||<|0.001|TWO_SIDED|95.0|-32.88|-14.7|||Mixed models repeated measures analysis|||Week 24||-14.70|-32.88|<0.001
71643992|NCT01592240|142806249|SUPERIORITY_OR_OTHER||Adjusted mean difference|-29.08|||<|0.001|TWO_SIDED|95.0|-38.13|-20.04|||Mixed models repeated measures analysis|||Week 24||-20.04|-38.13|<0.001
71643993|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.64||||0.281|TWO_SIDED|95.0|-1.35|4.63|||Mixed models repeated measures analysis|||Week 12||4.63|-1.35|0.281
71643994|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.73||||0.251|TWO_SIDED|95.0|-1.24|4.71|||Mixed models repeated measures analysis|||Week 12||4.71|-1.24|0.251
71643995|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.53||||0.724|TWO_SIDED|95.0|-2.43|3.5|||Mixed models repeated measures analysis|||Week 12||3.50|-2.43|0.724
71643996|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.45||||0.007|TWO_SIDED|95.0|1.21|7.7|||Mixed models repeated measures analysis|||Week 12||7.70|1.21|0.007
71643997|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.86||||0.019|TWO_SIDED|95.0|0.63|7.09|||Mixed models repeated measures analysis|||Week 12||7.09|0.63|0.019
71643998|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.72||||0.225|TWO_SIDED|95.0|-1.07|4.51|||Mixed models repeated measures analysis|||Week 24||4.51|-1.07|0.225
71643999|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.79||||0.571|TWO_SIDED|95.0|-1.97|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.97|0.571
71644000|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.49||||0.725|TWO_SIDED|95.0|-2.25|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-2.25|0.725
71644001|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.268|TWO_SIDED|95.0|-1.56|5.57|||Mixed models repeated measures analysis|||Week 24||5.57|-1.56|0.268
71644002|NCT01592240|142806250|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.996|TWO_SIDED|95.0|-3.55|3.54|||Mixed models repeated measures analysis|||Week 24||3.54|-3.55|0.996
71644003|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.41||||0.246|TWO_SIDED|95.0|-2.38|9.21|||Mixed models repeated measures analysis|||Week 12||9.21|-2.38|0.246
71644004|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.62||||0.371|TWO_SIDED|95.0|-3.14|8.38|||Mixed models repeated measures analysis|||Week 12||8.38|-3.14|0.371
71644005|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.35||||0.643|TWO_SIDED|95.0|-4.4|7.1|||Mixed models repeated measures analysis|||Week 12||7.10|-4.40|0.643
71644006|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.66||||0.018|TWO_SIDED|95.0|1.33|13.99|||Mixed models repeated measures analysis|||Week 12||13.99|1.33|0.018
71644007|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.52||||0.043|TWO_SIDED|95.0|0.22|12.83|||Mixed models repeated measures analysis|||Week 12||12.83|0.22|0.043
71644008|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.16|TWO_SIDED|95.0|-1.56|9.36|||Mixed models repeated measures analysis|||Week 24||9.36|-1.56|0.160
71644009|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.85||||0.758|TWO_SIDED|95.0|-4.56|6.25|||Mixed models repeated measures analysis|||Week 24||6.25|-4.56|0.758
71823810|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.47||0.0073|TWO_SIDED|95.0|-2.21|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-2.21|0.0073
71644010|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.57||||0.347|TWO_SIDED|95.0|-2.81|7.95|||Mixed models repeated measures analysis|||Week 24||7.95|-2.81|0.347
71644011|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.99||||0.343|TWO_SIDED|95.0|-3.22|9.21|||Mixed models repeated measures analysis|||Week 24||9.21|-3.22|0.343
71644012|NCT01592240|142806251|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7||||0.824|TWO_SIDED|95.0|-6.87|5.48|||Mixed models repeated measures analysis|||Week 24||5.48|-6.87|0.824
71644013|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.55|||<|0.001|TWO_SIDED|95.0|-25.44|-11.67|||Mixed models repeated measures analysis|||Week 12||-11.67|-25.44|<0.001
71644014|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.67|||<|0.001|TWO_SIDED|95.0|-34.55|-20.79|||Mixed models repeated measures analysis|||Week 12||-20.79|-34.55|<0.001
71644015|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.09|||<|0.001|TWO_SIDED|95.0|-38.95|-25.22|||Mixed models repeated measures analysis|||Week 12||-25.22|-38.95|<0.001
71644016|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-14.56|||<|0.001|TWO_SIDED|95.0|-22.89|-6.24|||Mixed models repeated measures analysis|||Week 12||-6.24|-22.89|<0.001
71644017|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.5|||<|0.001|TWO_SIDED|95.0|-36.83|-20.16|||Mixed models repeated measures analysis|||Week 12||-20.16|-36.83|<0.001
71644018|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.67|||<|0.001|TWO_SIDED|95.0|-27.07|-12.27|||Mixed models repeated measures analysis|||Week 24||-12.27|-27.07|<0.001
71644019|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.17|||<|0.001|TWO_SIDED|95.0|-35.52|-20.82|||Mixed models repeated measures analysis|||Week 24||-20.82|-35.52|<0.001
71644020|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.41|||<|0.001|TWO_SIDED|95.0|-32.73|-18.09|||Mixed models repeated measures analysis|||Week 24||-18.09|-32.73|<0.001
71644021|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.72|||<|0.001|TWO_SIDED|95.0|-19.35|-6.09|||Mixed models repeated measures analysis|||Week 24||-6.09|-19.35|<0.001
71644022|NCT01592240|142806252|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.85|||<|0.001|TWO_SIDED|95.0|-23.47|-10.23|||Mixed models repeated measures analysis|||Week 24||-10.23|-23.47|<0.001
71644023|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.58|||<|0.001|TWO_SIDED|95.0|-29.23|-13.92|||Mixed models repeated measures analysis|||Week 12||-13.92|-29.23|<0.001
71644024|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.54|||<|0.001|TWO_SIDED|95.0|-38.19|-22.89|||Mixed models repeated measures analysis|||Week 12||-22.89|-38.19|<0.001
71886195|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0029|TWO_SIDED|95.0|-0.55|-0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Daytime||-0.11|-0.55|0.0029
71644025|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-35.95|||<|0.001|TWO_SIDED|95.0|-43.59|-28.31|||Mixed models repeated measures analysis|||Week 12||-28.31|-43.59|<0.001
71644026|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.14|||<|0.001|TWO_SIDED|95.0|-25.87|-8.41|||Mixed models repeated measures analysis|||Week 12||-8.41|-25.87|<0.001
71644027|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.72|||<|0.001|TWO_SIDED|95.0|-39.45|-21.98|||Mixed models repeated measures analysis|||Week 12||-21.98|-39.45|<0.001
71644028|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.09|||<|0.001|TWO_SIDED|95.0|-30.32|-13.86|||Mixed models repeated measures analysis|||Week 24||-13.86|-30.32|<0.001
71644029|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-30.95|||<|0.001|TWO_SIDED|95.0|-39.13|-22.77|||Mixed models repeated measures analysis|||Week 24||-22.77|-39.13|<0.001
71644030|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.23|||<|0.001|TWO_SIDED|95.0|-35.38|-19.09|||Mixed models repeated measures analysis|||Week 24||-19.09|-35.38|<0.001
71644031|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.34|||<|0.001|TWO_SIDED|95.0|-22.9|-7.78|||Mixed models repeated measures analysis|||Week 24||-7.78|-22.90|<0.001
71644032|NCT01592240|142806253|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.15|||<|0.001|TWO_SIDED|95.0|-26.7|-11.59|||Mixed models repeated measures analysis|||Week 24||-11.59|-26.70|<0.001
71644033|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.77||||0.667|TWO_SIDED|95.0|-6.33|9.88|||Mixed models repeated measures analysis|||Week 12||9.88|-6.33|0.667
71644034|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.44||||0.187|TWO_SIDED|95.0|-2.66|13.54|||Mixed models repeated measures analysis|||Week 12||13.54|-2.66|0.187
71644035|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.82||||0.352|TWO_SIDED|95.0|-4.25|11.9|||Mixed models repeated measures analysis|||Week 12||11.90|-4.25|0.352
71644036|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.6||||0.09|TWO_SIDED|95.0|-0.89|12.09|||Mixed models repeated measures analysis|||Week 12||12.09|-0.89|0.090
71644037|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.36||||0.184|TWO_SIDED|95.0|-2.1|10.82|||Mixed models repeated measures analysis|||Week 12||10.82|-2.10|0.184
71644038|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.59||||0.879|TWO_SIDED|95.0|-7.09|8.28|||Mixed models repeated measures analysis|||Week 24||8.28|-7.09|0.879
71644039|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.911|TWO_SIDED|95.0|-7.17|8.02|||Mixed models repeated measures analysis|||Week 24||8.02|-7.17|0.911
71644040|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.283|TWO_SIDED|95.0|-3.44|11.69|||Mixed models repeated measures analysis|||Week 24||11.69|-3.44|0.283
71644041|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41||||0.728|TWO_SIDED|95.0|-9.41|6.59|||Mixed models repeated measures analysis|||Week 24||6.59|-9.41|0.728
71644042|NCT01592240|142806254|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19||||0.587|TWO_SIDED|95.0|-10.13|5.75|||Mixed models repeated measures analysis|||Week 24||5.75|-10.13|0.587
71644043|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66||||0.89|TWO_SIDED|95.0|-10.05|8.74|||Mixed models repeated measures analysis|||Week 12||8.74|-10.05|0.890
71644044|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.32||||0.625|TWO_SIDED|95.0|-7.04|11.68|||Mixed models repeated measures analysis|||Week 12||11.68|-7.04|0.625
71644045|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|6.54||||0.172|TWO_SIDED|95.0|-2.86|15.94|||Mixed models repeated measures analysis|||Week 12||15.94|-2.86|0.172
71644046|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.5||||0.109|TWO_SIDED|95.0|-0.79|7.8|||Mixed models repeated measures analysis|||Week 12||7.80|-0.79|0.109
71644047|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.67||||0.218|TWO_SIDED|95.0|-1.6|6.94|||Mixed models repeated measures analysis|||Week 12||6.94|-1.60|0.218
71644048|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86||||0.812|TWO_SIDED|95.0|-8.01|6.29|||Mixed models repeated measures analysis|||Week 24||6.29|-8.01|0.812
71644049|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.749|TWO_SIDED|95.0|-8.24|5.94|||Mixed models repeated measures analysis|||Week 24||5.94|-8.24|0.749
71644050|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.82||||0.108|TWO_SIDED|95.0|-1.29|12.93|||Mixed models repeated measures analysis|||Week 24||12.93|-1.29|0.108
71644051|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.752|TWO_SIDED|95.0|-5.99|4.34|||Mixed models repeated measures analysis|||Week 24||4.34|-5.99|0.752
71644052|NCT01592240|142806255|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.55||||0.55|TWO_SIDED|95.0|-6.68|3.57|||Mixed models repeated measures analysis|||Week 24||3.57|-6.68|0.550
71644053|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.893|TWO_SIDED|95.0|-2.62|3.0|||Mixed models repeated measures analysis|||Week 12||3.00|-2.62|0.893
71644054|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.33||||0.355|TWO_SIDED|95.0|-1.49|4.15|||Mixed models repeated measures analysis|||Week 12||4.15|-1.49|0.355
71644055|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64||||0.655|TWO_SIDED|95.0|-3.45|2.17|||Mixed models repeated measures analysis|||Week 12||2.17|-3.45|0.655
71644056|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.49||||0.719|TWO_SIDED|95.0|-3.2|2.21|||Mixed models repeated measures analysis|||Week 12||2.21|-3.20|0.719
71644057|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.41||||0.768|TWO_SIDED|95.0|-2.31|3.12|||Mixed models repeated measures analysis|||Week 12||3.12|-2.31|0.768
71644058|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.66||||0.199|TWO_SIDED|95.0|-0.88|4.2|||Mixed models repeated measures analysis|||Week 24||4.20|-0.88|0.199
71644059|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.9||||0.483|TWO_SIDED|95.0|-1.62|3.41|||Mixed models repeated measures analysis|||Week 24||3.41|-1.62|0.483
71644060|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.03||||0.42|TWO_SIDED|95.0|-1.49|3.56|||Mixed models repeated measures analysis|||Week 24||3.56|-1.49|0.420
71644061|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69||||0.488|TWO_SIDED|95.0|-2.67|1.28|||Mixed models repeated measures analysis|||Week 24||1.28|-2.67|0.488
71644062|NCT01592240|142806256|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.694|TWO_SIDED|95.0|-2.36|1.58|||Mixed models repeated measures analysis|||Week 24||1.58|-2.36|0.694
71644063|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|10.29||||0.527|TWO_SIDED|95.0|-21.73|42.3|||Mixed models repeated measures analysis|||Week 12||42.30|-21.73|0.527
71644064|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39||||0.981|TWO_SIDED|95.0|-31.49|32.26|||Mixed models repeated measures analysis|||Week 12||32.26|-31.49|0.981
71644065|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54||||0.974|TWO_SIDED|95.0|-31.72|32.8|||Mixed models repeated measures analysis|||Week 12||32.80|-31.72|0.974
71644066|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.58||||0.64|TWO_SIDED|95.0|-8.25|5.09|||Mixed models repeated measures analysis|||Week 12||5.09|-8.25|0.640
71644067|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.08||||0.75|TWO_SIDED|95.0|-5.61|7.77|||Mixed models repeated measures analysis|||Week 12||7.77|-5.61|0.750
71644068|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|9.8||||0.509|TWO_SIDED|95.0|-19.41|39.01|||Mixed models repeated measures analysis|||Week 24||39.01|-19.41|0.509
71644069|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.69||||0.855|TWO_SIDED|95.0|-31.76|26.38|||Mixed models repeated measures analysis|||Week 24||26.38|-31.76|0.855
71644070|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.04||||0.839|TWO_SIDED|95.0|-26.39|32.47|||Mixed models repeated measures analysis|||Week 24||32.47|-26.39|0.839
71644071|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99||||0.392|TWO_SIDED|95.0|-6.57|2.59|||Mixed models repeated measures analysis|||Week 24||2.59|-6.57|0.392
71644072|NCT01592240|142806257|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.33||||0.565|TWO_SIDED|95.0|-5.91|3.24|||Mixed models repeated measures analysis|||Week 24||3.24|-5.91|0.565
71644073|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.964|||<|0.001|TWO_SIDED|95.0|3.997|56.02|||Regression, Logistic|||Week 12, Less than 100 mg/dL||56.020|3.997|<0.001
71644074|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.615|||<|0.001|TWO_SIDED|95.0|7.984|308.328|||Regression, Logistic|||Week 12, Less than 100 mg/dL||308.328|7.984|<0.001
71644075|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.842|||<|0.001|TWO_SIDED|95.0|3.674|44.892|||Regression, Logistic|||Week 12, Less than 100 mg/dL||44.892|3.674|<0.001
71644076|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.107||||0.01|TWO_SIDED|95.0|1.304|7.401|||Regression, Logistic|||Week 12, Less than 100 mg/dL||7.401|1.304|0.010
71644077|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.048|||<|0.001|TWO_SIDED|95.0|2.402|15.225|||Regression, Logistic|||Week 12, Less than 100 mg/dL||15.225|2.402|<0.001
71644078|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.773|||<|0.001|TWO_SIDED|95.0|3.932|41.495|||Regression, Logistic|||Week 24, Less than 100 mg/dL||41.495|3.932|<0.001
71644079|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.886|||<|0.001|TWO_SIDED|95.0|8.33|163.335|||Regression, Logistic|||Week 24, Less than 100 mg/dL||163.335|8.330|<0.001
71644080|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.75|||<|0.001|TWO_SIDED|95.0|5.741|75.006|||Regression, Logistic|||Week 24, Less than 100 mg/dL||75.006|5.741|<0.001
71644081|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.219||||0.001|TWO_SIDED|95.0|2.061|18.764|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.764|2.061|0.001
71644082|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.205||||0.001|TWO_SIDED|95.0|2.06|18.693|||Regression, Logistic|||Week 24, Less than 100 mg/dL||18.693|2.060|0.001
71644083|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.703|||<|0.001|TWO_SIDED|95.0|5.752|133.423|||Regression, Logistic|||Week 12, Less than 70 mg/dL||133.423|5.752|<0.001
71644084|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.177|||<|0.001|TWO_SIDED|95.0|13.783|367.564|||Regression, Logistic|||Week 12, Less than 70 mg/dL||367.564|13.783|<0.001
71644085|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|100.667|||<|0.001|TWO_SIDED|95.0|19.855|510.387|||Regression, Logistic|||Week 12, Less than 70 mg/dL||510.387|19.855|<0.001
71644086|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 70 mg/dL.||||<0.001
71644087|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.941|||<|0.001|TWO_SIDED|95.0|6.336|98.169|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.169|6.336|<0.001
71644088|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|80.004|||<|0.001|TWO_SIDED|95.0|18.094|353.742|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||353.742|18.094|<0.001
71644089|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.101|||<|0.001|TWO_SIDED|95.0|10.621|166.894|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||166.894|10.621|<0.001
71644090|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.023|TWO_SIDED|95.0|1.396|98.075|||Regression, Logistic|||Week 24, Less than 70 mg/dL.||98.075|1.396|0.023
71644091|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.841|||<|0.001|TWO_SIDED|95.0|4.527|299.817|||Regression, Logistic|||Week 24, Less than 70 mg/dL||299.817|4.527|<0.001
71644092|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
71644093|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
71823811|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.48||0.0054|TWO_SIDED|95.0|-2.28|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-2.28|0.0054
71644094|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.||||<0.001
71644095|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
71644096|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
71644097|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.||||<0.001
71644098|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
71644099|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
71644100|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.||||<0.001
71644101|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.587||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
71644102|NCT01592240|142806271|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL.||||<0.001
71644103|NCT01592240|142806271|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.925||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL||||1.000
71644104|NCT01011413|142806284|NON_INFERIORITY|"Only the primary endpoint is assessed in terms of non-inferiority. All other comparisons are tests for superiority and are considered statistically significant at a two-sided alpha=0.05.~Non-inferiority of EFV 400 mg was defined as the lower 95% confidence interval (CI) of the difference between groups in the proportion of viral load below 200 copies/mL at week 48 lying above -10%."||||||0.05||||||No adjustments were made for multiple comparisons|Pearson's chi-squared|Pearson's chi-squared or Fisher's exact test derived p value was used||Sample size calculation assumes 85% of participants randomised to 600mg EFV arm will have plasma HIV RNA \<200 copies/ml at 48 weeks. Assuming no difference between randomised treatments in proportion with plasma HIV RNA \<200 copies/mL, to have 90% power to demonstrate non-inferiority in the intention to treat (ITT) analysis using a 10% non-inferiority margin will require 286 participants per arm, making a total of 572 participants. Power for modified ITT analysis was 93%.||||0.05
71644105|NCT01011413|142806284|NON_INFERIORITY|Non-inferiority will be defined as the lower 95% confidence limit of the difference in percentages of patients with undetectable viral load lying above -10% (i.e. a non-inferiority margin of 10%).||||||0.05||||||No adjustment for multiple comparisons|Chi-squared|||To ensure the per protocol (PP) analysis has 90% power to demonstrate non-inferiority, the sample size was inflated for patients who switch treatment for toxicity. This is estimated to be no more than 10% randomised patients. To ensure 90% power to demonstrate non-inferiority in the ITT and PP analyses, a total of 630 (315 per arm) patients will be randomised giving 93% power for the ITT analysis. Null hypothesis: no statistically significant difference between the 600mg and 400mg EFV regimens.||||0.05
71644106|NCT01011413|142806285|SUPERIORITY_OR_OTHER_LEGACY||difference between proportions|0.05||||0.05|TWO_SIDED|95.0||||P-value not adjusted for multiple comparisons|Chi-squared|||||||0.05
71644107|NCT03246503|142806294|OTHER||Pearson correlation coefficient|0.82|||<|0.001|TWO_SIDED|95.0|0.77|0.87||statistical significance of Pearson correlation coefficient|Pearson correlation coefficient||Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.|Bootstrapping with 1000 replications was used to estimate 95% confidence intervals.||.87|0.77|<.001
71644108|NCT03246503|142806295|OTHER|t-statistic from regression analysis|intercept of regression line|4.13|||<|0.001|TWO_SIDED|95.0|3.35|4.91|||Regression, Linear|||||4.91|3.35|<.001
71644109|NCT03246503|142806296|OTHER|t-statistic from regression analysis|Slope|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Regression, Linear|||||0.76|0.60|<.001
71644110|NCT03206749|142806337|SUPERIORITY||Least Squares (LS) Mean Difference|29.5|||<|0.0001|TWO_SIDED|95.0|16.61|42.4|||ANCOVA|||||42.40|16.61|<0.0001
71644111|NCT03206749|142806338|SUPERIORITY||LS Mean Difference|28.53|||<|0.0001|TWO_SIDED|95.0|16.18|40.88|||ANCOVA|||||40.88|16.18|<0.0001
71644112|NCT03206749|142806339|SUPERIORITY||LS Mean Difference|62.79|||<|0.0001|TWO_SIDED|95.0|36.3|89.27|||ANCOVA|||||89.27|36.30|<0.0001
71644113|NCT03206749|142806340|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0469|TWO_SIDED|95.0|1.01|2.16|||Regression, Cox|||||2.16|1.01|0.0469
71644114|NCT03206749|142806341|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.3294|TWO_SIDED|95.0|0.79|2.0|||Regression, Cox|||||2.00|0.79|0.3294
71644115|NCT03206749|142806342|SUPERIORITY|||||||0.2341|||||||Regression, Cox|||||||0.2341
71644116|NCT03206749|142806343|SUPERIORITY|||||||0.3358||||||0 - 24 hours|Cochran-Mantel-Haenszel|||||||0.3358
71644117|NCT03206749|142806343|SUPERIORITY|||||||0.0849||||||Greater than (\>) 24 - 48 hours|Cochran-Mantel-Haenszel|||||||0.0849
71644118|NCT03206749|142806344|SUPERIORITY|||||||0.0004||||||0 - 24 hours|Wilcoxon rank-sum test|||||||0.0004
71644119|NCT03206749|142806344|SUPERIORITY|||||||0.0035||||||\>24 - 48 hours|Wilcoxon rank-sum test|||||||0.0035
71644120|NCT01492439|142806349|SUPERIORITY_OR_OTHER|||||||0.029||||||This applies to Semester 1.|t-test, 1 sided|||||||0.029
71644121|NCT01492439|142806349|SUPERIORITY_OR_OTHER|||||||0.225||||||This applies to semester 2.|t-test, 1 sided|||||||0.225
71644122|NCT01492439|142806350|SUPERIORITY_OR_OTHER|||||||0.247||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.247
71644123|NCT01492439|142806350|SUPERIORITY_OR_OTHER|||||||0.747||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.747
71644124|NCT01492439|142806350|SUPERIORITY_OR_OTHER|||||||0.582||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.582
71644125|NCT01492439|142806351|SUPERIORITY_OR_OTHER|||||||0|||||||ANCOVA|||||||0.000
71644126|NCT01492439|142806352|SUPERIORITY_OR_OTHER|||||||0.95||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA|||||||0.950
71644127|NCT01492439|142806352|SUPERIORITY_OR_OTHER|||||||0.027||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA|||||||0.027
71644128|NCT01492439|142806352|SUPERIORITY_OR_OTHER|||||||0.639||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA|||||||0.639
71886196|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0012|TWO_SIDED|95.0|-0.58|-0.14|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Daytime||-0.14|-0.58|0.0012
71644129|NCT01492439|142806353|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|||||||0.008
71644130|NCT01492439|142806354|SUPERIORITY_OR_OTHER|||||||0.314||||||This applies to Trial 1 on the CVLT.|ANCOVA|||||||0.314
71644131|NCT01492439|142806354|SUPERIORITY_OR_OTHER|||||||0.242||||||This applies to the total score of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.242
71644132|NCT01492439|142806354|SUPERIORITY_OR_OTHER|||||||0.669||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.669
71644133|NCT01492439|142806355|SUPERIORITY_OR_OTHER|||||||0.139||||||This applies to the 'trial 1' subtest of the CVLT.|ANCOVA|||||||0.139
71644134|NCT01492439|142806355|SUPERIORITY_OR_OTHER|||||||0.269||||||This applies to the total of trials 1-4 (total free recall) of the CVLT.|ANCOVA|||||||0.269
71644135|NCT01492439|142806355|SUPERIORITY_OR_OTHER|||||||0.666||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA|||||||0.666
71644136|NCT01492439|142806356|SUPERIORITY_OR_OTHER|||||||0.391|||||||ANCOVA|||||||0.391
71644137|NCT01492439|142806357|SUPERIORITY_OR_OTHER|||||||0.958|||||||ANCOVA|||||||0.958
71644138|NCT01492439|142806358|SUPERIORITY_OR_OTHER|||||||0.754||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.754
71644139|NCT01492439|142806358|SUPERIORITY_OR_OTHER|||||||0.518||||||This applies to the 'backward' sequence of the Digit Span Test.|ANCOVA|||||||0.518
71644140|NCT01492439|142806358|SUPERIORITY_OR_OTHER|||||||0.531||||||This applies to the total score (forward+backwards) on the Digit Span Test.|ANCOVA|||||||0.531
71644141|NCT01492439|142806359|SUPERIORITY_OR_OTHER|||||||0.802||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA|||||||0.802
71644142|NCT01492439|142806359|SUPERIORITY_OR_OTHER|||||||0.091||||||This applies to the 'backwards' sequence of the Digit Span Test.|ANCOVA|||||||0.091
71644143|NCT01492439|142806359|SUPERIORITY_OR_OTHER|||||||0.171||||||This applies to the total score (forward + backwards) on the Digit Span Test.|ANCOVA|||||||0.171
71644144|NCT01492439|142806360|SUPERIORITY_OR_OTHER|||||||0.267|||||||ANCOVA|||||||0.267
71644145|NCT01492439|142806361|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANCOVA|||||||0.527
71644146|NCT01492439|142806362|SUPERIORITY_OR_OTHER|||||||0.852||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.852
71644147|NCT01492439|142806362|SUPERIORITY_OR_OTHER|||||||0.637||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.637
71644148|NCT01492439|142806363|SUPERIORITY_OR_OTHER|||||||0.612||||||This applies to the total number of correct categories on the WCST|ANCOVA|||||||0.612
71644149|NCT01492439|142806364|SUPERIORITY_OR_OTHER|||||||0.156||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA|||||||0.156
71644150|NCT01492439|142806364|SUPERIORITY_OR_OTHER|||||||0.926||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA|||||||0.926
71644151|NCT01492439|142806365|SUPERIORITY_OR_OTHER|||||||0.843|||||||ANCOVA|||This applies to the total number of categories on the WCST.||||0.843
71644152|NCT01492439|142806366|SUPERIORITY_OR_OTHER|||||||0.129||||||This applies to the total number of errors made on the DVT.|ANCOVA|||||||0.129
71644153|NCT01492439|142806367|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.004
71644154|NCT01492439|142806368|SUPERIORITY_OR_OTHER|||||||0.853|||||||ANCOVA|This applies to the total number of errors on the DVT.||||||0.853
71644155|NCT01492439|142806369|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||This applies to the total time taken to complete the DVT.||||0.468
71823812|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.01|-1.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.12|-3.01|< 0.0001
71644156|NCT00395694|142806388|SUPERIORITY_OR_OTHER||Percentage of participants|4.9|||||TWO_SIDED|95.0|1.6|11.1|||||The estimated value represents the percentage of participants with rash events.|||11.1|1.6|
71644157|NCT01648582|142806400|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.74|-0.4||||||||-0.40|-0.74|
71644158|NCT01648582|142806400|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.18|||||TWO_SIDED|95.0|-0.35|-0.01||||||||-0.01|-0.35|
71644159|NCT01648582|142806401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.77|-0.38||||||||-0.38|-0.77|
71644160|NCT01648582|142806401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.33|-0.06||||||||-0.06|-0.33|
71644161|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||\<7.0% Week 26||||<0.001
71644162|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||\<7.0 Week 26||||0.004
71644163|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
71644164|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 26||||<0.001
71644165|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<7.0% Week 52||||<0.001
71886197|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0829|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Daytime||0.25|-0.02|0.0829
71644166|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Fisher Exact|||\<7.0% Week 52||||0.002
71644167|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
71644168|NCT01648582|142806402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||\<=6.5% Week 52||||<0.001
71644169|NCT01648582|142806403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.24||||0.177|TWO_SIDED|95.0|-0.11|0.59|||Mixed Models Analysis|||Week 26||0.59|-0.11|0.177
71644170|NCT01648582|142806403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.88|||<|0.001|TWO_SIDED|95.0|0.53|1.23|||Mixed Models Analysis|||Week 26||1.23|0.53|<0.001
71644171|NCT01648582|142806403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.518|TWO_SIDED|95.0|-0.25|0.5|||Mixed Models Analysis|||Week 52||0.50|-0.25|0.518
71644172|NCT01648582|142806403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.82|||<|0.001|TWO_SIDED|95.0|0.45|1.2|||Mixed Models Analysis|||Week 52||1.20|0.45|<0.001
71644173|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|||<|0.001|TWO_SIDED|95.0|0.42|0.88|||Mixed Models Analysis|||Morning pre-meal, Week 26||0.88|0.42|<0.001
71644174|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||Morning pre-meal, Week 26||1.17|0.71|<0.001
71644175|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.49||||0.024|TWO_SIDED|95.0|-0.92|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||-0.07|-0.92|0.024
71644176|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.617|TWO_SIDED|95.0|-0.53|0.32|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26||0.32|-0.53|0.617
71644177|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.055|TWO_SIDED|95.0|-0.7|0.01|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.01|-0.70|0.055
71644178|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.03||||0.855|TWO_SIDED|95.0|-0.32|0.39|||Mixed Models Analysis|||Mid-day pre-meal, Week 26||0.39|-0.32|0.855
71644179|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.05|||<|0.001|TWO_SIDED|95.0|-1.46|-0.64|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.64|-1.46|<0.001
71644180|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.01|-0.19|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26||-0.19|-1.01|0.004
71644181|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.97|-0.29|||Mixed Models Analysis|||Evening pre-meal, Week 26||-0.29|-0.97|<0.001
71644182|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.489|TWO_SIDED|95.0|-0.45|0.22|||Mixed Models Analysis|||Evening pre-meal, Week 26||0.22|-0.45|0.489
71644183|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.89|||<|0.001|TWO_SIDED|95.0|-1.3|-0.48|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.48|-1.30|<0.001
71644184|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.47||||0.024|TWO_SIDED|95.0|-0.88|-0.06|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26||-0.06|-0.88|0.024
71644185|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.79|||<|0.001|TWO_SIDED|95.0|-1.17|-0.41|||Mixed Models Analysis|||Bedtime, Week 26||-0.41|-1.17|<0.001
71644186|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.35||||0.067|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Analysis|||Bedtime, Week 26||-0.03|-0.73|0.067
71644187|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.77|||<|0.001|TWO_SIDED|95.0|0.52|1.01|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.01|0.52|<0.001
71644188|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|0.82|1.31|||Mixed Models Analysis|||Morning pre-meal, Week 52||1.31|0.82|<0.001
71644189|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.53||||0.025|TWO_SIDED|95.0|-1.0|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||-0.07|-1.00|0.025
71644190|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21||||0.384|TWO_SIDED|95.0|-0.67|0.26|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52||0.26|-0.67|0.384
71644191|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.43||||0.024|TWO_SIDED|95.0|-0.8|-0.06|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||-0.06|-0.80|0.024
71644192|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05||||0.783|TWO_SIDED|95.0|-0.32|0.42|||Mixed Models Analysis|||Mid-day pre-meal, Week 52||0.42|-0.32|0.783
71644193|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.63||||0.004|TWO_SIDED|95.0|-1.07|-0.2|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.20|-1.07|0.004
71644194|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.48||||0.029|TWO_SIDED|95.0|-0.92|-0.05|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52||-0.05|-0.92|0.029
71644195|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-1.01|-0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||-0.27|-1.01|<0.001
71644196|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.603|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52||0.27|-0.47|0.603
71644197|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.26|-0.41|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.41|-1.26|<0.001
71644198|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52||-0.02|-0.87|0.039
71644199|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.39|-0.6|||Mixed Models Analysis|||Bedtime, Week 52||-0.60|-1.39|<0.001
71644200|NCT01648582|142806404|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.59||||0.003|TWO_SIDED|95.0|-0.98|-0.2|||Mixed Models Analysis|||Bedtime, Week 52||-0.20|-0.98|0.003
71644201|NCT01648582|142806405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.41|STANDARD_ERROR_OF_MEAN|3.831||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5 mg, Week 26||||0.352
71644202|NCT01648582|142806405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|31.17|STANDARD_ERROR_OF_MEAN|3.761||0.352|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 26||||0.352
71644203|NCT01648582|142806405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.12|STANDARD_ERROR_OF_MEAN|4.147||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5, Week 52||||0.025
71644204|NCT01648582|142806405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.64|STANDARD_ERROR_OF_MEAN|4.061||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 52||||0.025
71644205|NCT01648582|142806406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|36.57|STANDARD_ERROR_OF_MEAN|2.977||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 26||||0.025
71644206|NCT01648582|142806406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.42|STANDARD_ERROR_OF_MEAN|2.94||0.025|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 26||||0.025
71644207|NCT01648582|142806406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|41.02|STANDARD_ERROR_OF_MEAN|2.9||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 52||||0.029
71644208|NCT01648582|142806406|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.19|STANDARD_ERROR_OF_MEAN|2.864||0.029|TWO_SIDED||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 52||||0.029
71644209|NCT01648582|142806409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Overall p-value|Mixed Models Analysis|||Week 26 SBP||||0.008
71644210|NCT01648582|142806409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.584||||||Overall p-value|Mixed Models Analysis|||Week 26 DBP||||0.584
71644211|NCT01648582|142806409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||||||Overall p-value|Mixed Models Analysis|||Week 52 SBP||||0.169
71644212|NCT01648582|142806409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||Overall p-value|Mixed Models Analysis|||Week 52 DBP||||0.110
71644213|NCT01648582|142806410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 26||||<0.001
71644214|NCT01648582|142806410|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 52||||<0.001
71644215|NCT01648582|142806417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 26|Mixed Models Analysis|||||||<0.001
71644216|NCT01648582|142806417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
71644217|NCT01648582|142806418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 26||||<0.001
71644218|NCT01648582|142806418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Week 52||||<0.001
71644219|NCT01058668|142806433|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-3.8|-8.4|<0.001
71644220|NCT01058668|142806433|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|||<|0.001|TWO_SIDED|95.0|-8.2|-3.6|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-3.6|-8.2|<0.001
71644221|NCT01058668|142806434|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo|||-0.4|-0.9|<0.001
71644222|NCT01058668|142806434|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo|||-0.3|-0.9|<0.001
71644223|NCT04859517|142806435|SUPERIORITY||Risk Difference (RD)|-5.0||||0.0123|TWO_SIDED|95.0|-8.87|-1.08|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.08|-8.87|0.0123
71644224|NCT04859517|142806436|SUPERIORITY||Risk Difference (RD)|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.75|-2.01|||Regression, Logistic|||||-2.01|-5.75|<0.0001
71644225|NCT04859517|142806439|SUPERIORITY||Standardized Risk Difference|-7.6||||0.0153|TWO_SIDED|95.0|-13.74|-1.46|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-1.46|-13.74|0.0153
71644226|NCT04859517|142806440|SUPERIORITY||Risk Difference (RD)|-4.4||||0.0612|TWO_SIDED|95.0|-9.03|0.21|||Regression, Logistic||||A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|0.21|-9.03|0.0612
71644227|NCT04859517|142806459|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.0077|TWO_SIDED|95.0|0.06|0.76|||Log Rank|||||0.76|0.06|0.0077
71644228|NCT04859517|142806460|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.49|||Log Rank|||||0.49|0.14|<0.0001
71644229|NCT01068821|142806461|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student's T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher's Exact test.||||0.1
71644230|NCT01068821|142806462|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||Fischer's exact test, significance defined as p\<0.05||||0.5
71644231|NCT00908128|142806463|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.96||||||90.0|82.4|100.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.41|82.40|
71644232|NCT00908128|142806464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.16||||||90.0|96.24|102.16|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.16|96.24|
71644233|NCT00908128|142806465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.78||||||90.0|95.76|101.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.89|95.76|
71644234|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.751|1.03||||||Serogroup A: Lot 1 vs Lot 2||1.03|0.751|
71644235|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.985|||||TWO_SIDED|95.0|0.843|1.15||||||Serogroup A: Lot 2 vs Lot 3||1.15|0.843|
71644236|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.867|||||TWO_SIDED|95.0|0.74|1.02||||||Serogroup A: Lot 1 vs Lot 3||1.02|0.740|
71644237|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.888|1.29||||||Serogroup C: Lot 1 vs Lot 2||1.29|0.888|
71644238|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.866|||||TWO_SIDED|95.0|0.714|1.05||||||Serogroup C: Lot 2 vs Lot 3||1.05|0.714|
71644239|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.927|||||TWO_SIDED|95.0|0.766|1.12||||||Serogroup C: Lot 1 vs Lot 3||1.12|0.766|
71644240|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.869|1.19||||||Serogroup Y: Lot 1 vs Lot 2||1.19|0.869|
71644241|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.961|||||TWO_SIDED|95.0|0.816|1.13||||||Serogroup Y: Lot 2 vs Lot 3||1.13|0.816|
71644242|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.975|||||TWO_SIDED|95.0|0.829|1.15||||||Serogroup Y: Lot 1 vs Lot 3||1.15|0.829|
71644243|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.878|1.22||||||Serogroup W: Lot 1 vs Lot 2||1.22|0.878|
71644244|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.791|1.11||||||Serogroup W: Lot 2 vs Lot 3||1.11|0.791|
71644245|NCT02842853|142806466|EQUIVALENCE|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.818|1.15||||||Serogroup W: Lot 1 vs Lot 3||1.15|0.818|
71644246|NCT02842853|142806467|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.8|23.5||||||Serogroup A||23.5|14.8|
71644247|NCT02842853|142806467|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|40.9|||||TWO_SIDED|95.0|36.7|45.0||||||Serogroup C||45|36.7|
71644248|NCT02842853|142806467|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.1|||||TWO_SIDED|95.0|14.5|21.9||||||Serogroup Y||21.9|14.5|
71644249|NCT02842853|142806467|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.1|||||TWO_SIDED|95.0|14.9|23.3||||||Serogroup W||23.3|14.9|
71644250|NCT02842853|142806468|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|19.6|||||TWO_SIDED|95.0|13.5|25.8||||||Serogroup A||25.8|13.5|
71644251|NCT02842853|142806468|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|41.1|||||TWO_SIDED|95.0|35.0|46.9||||||Serogroup C||46.9|35.0|
71644252|NCT02842853|142806468|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|27.4|||||TWO_SIDED|95.0|21.7|33.3||||||Serogroup Y||33.3|21.7|
71644253|NCT02842853|142806468|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|26.8|||||TWO_SIDED|95.0|20.7|32.9||||||Serogroup W||32.9|20.7|
71644254|NCT02842853|142806469|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|18.7|||||TWO_SIDED|95.0|12.5|24.9||||||Serogroup A||24.9|12.5|
71644255|NCT02842853|142806469|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|42.3|||||TWO_SIDED|95.0|36.6|48.0||||||Serogroup C||48.0|36.6|
71644256|NCT02842853|142806469|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|10.0|||||TWO_SIDED|95.0|6.18|14.5||||||Serogroup Y||14.5|6.18|
71644257|NCT02842853|142806469|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is \> -10% for all serogroups.|Percentage Difference|12.5|||||TWO_SIDED|95.0|7.22|18.2||||||Serogroup W||18.2|7.22|
71644258|NCT02842853|142806470|OTHER||Percentage Difference|-5.4|||||TWO_SIDED|95.0|-9.59|-1.16||||||Serogroup A: Lot 1 vs Lot 2||-1.16|-9.59|
71644259|NCT02842853|142806470|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-1.3|7.01||||||Serogroup A: Lot 2 vs Lot 3||7.01|-1.3|
71644260|NCT02842853|142806470|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-6.78|1.74||||||Serogroup A: Lot 1 vs Lot 3||1.74|-6.78|
71644261|NCT02842853|142806470|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-1.58|4.28||||||Serogroup C: Lot 1 vs Lot 2||4.28|-1.58|
71644262|NCT02842853|142806470|OTHER||Percentage Difference|2.4|||||TWO_SIDED|95.0|-0.74|5.54||||||Serogroup C: Lot 2 vs Lot 3||5.54|-0.740|
71644263|NCT02842853|142806470|OTHER||Percentage Difference|3.7|||||TWO_SIDED|95.0|0.708|6.79||||||Serogroup C: Lot 1 vs Lot 3||6.79|0.708|
71644264|NCT02842853|142806470|OTHER||Percentage Difference|0.5|||||TWO_SIDED|95.0|-2.14|3.07||||||Serogroup Y: Lot 1 vs Lot 2||3.07|-2.14|
71644265|NCT02842853|142806470|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-0.763|4.79||||||Serogroup Y: Lot 2 vs Lot 3||4.79|-0.763|
71644266|NCT02842853|142806470|OTHER||Percentage Difference|2.5|||||TWO_SIDED|95.0|-0.248|5.2||||||Serogroup Y: Lot 1 vs Lot 3||5.20|-0.248|
71644267|NCT02842853|142806470|OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-3.0|4.54||||||Serogroup W: Lot 1 vs Lot 2||4.54|-3.00|
71644268|NCT02842853|142806470|OTHER||Percentage Difference|2.0|||||TWO_SIDED|95.0|-1.84|5.89||||||Serogroup W: Lot 2 vs Lot 3||5.89|-1.84|
71644269|NCT02842853|142806470|OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.02|6.61||||||Serogroup W: Lot 1 vs Lot 3||6.61|-1.02|
71644270|NCT02842853|142806471|OTHER||GMT Ratio|1.93|||||TWO_SIDED|95.0|1.67|2.24||||||Serogroup A||2.24|1.67|
71644271|NCT02842853|142806471|OTHER||GMT Ratio|8.05|||||TWO_SIDED|95.0|6.58|9.84||||||Serogroup C||9.84|6.58|
71644272|NCT02842853|142806471|OTHER||GMT Ratio|3.22|||||TWO_SIDED|95.0|2.71|3.84||||||Serogroup Y||3.84|2.71|
71644273|NCT02842853|142806471|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.61|2.24||||||Serogroup W||2.24|1.61|
71644274|NCT00506831|142806519|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Null hypothesis is that the mRSS is not significantly different at month 6 compared with baseline. Paired t-test was used to compare the mean mRSS at month 6 compared with baseline.||||0.005
71644275|NCT02488239|142806540|OTHER||||||<|0.001|||||||exact binomial rate|||||||<0.001
71644276|NCT02488239|142806541|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71644277|NCT00608322|142806559|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.37|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
71644278|NCT00834444|142806561|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.9||||||90.0|87.8|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107|87.8|
71644279|NCT00834444|142806562|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.9|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.9|
71644280|NCT00834444|142806563|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|97.7|
71644281|NCT00835614|142806564|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.9||||||90.0|87.5|94.4|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94.4|87.5|
71644282|NCT00835614|142806565|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.1||||||90.0|90.3|93.9|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||93.9|90.3|
71644283|NCT00835614|142806566|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.2||||||90.0|90.4|94.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||94|90.4|
71644284|NCT00606281|142806567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-9.4|-2.7|||ANCOVA|||||-2.7|-9.4|<0.001
71644285|NCT00606281|142806568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|<0.001
71644286|NCT00829712|142806570|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.95||||||90.0|94.02|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.39|94.02|
71644287|NCT00829712|142806571|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|95.08|103.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.19|95.08|
71644288|NCT00829712|142806572|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.94||||||90.0|96.08|103.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.95|96.08|
71644289|NCT02213263|142806594|EQUIVALENCE|Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.|Difference in ORR|4.66|||||TWO_SIDED|95.0|-4.16|13.47||||||Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||13.47|-4.16|
71644290|NCT02213263|142806600|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.45|TWO_SIDED|95.0|0.786|1.72||A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||1.720|0.786|0.450
71644291|NCT02213263|142806601|SUPERIORITY||Hazard Ratio (HR)|1.393||||0.189|TWO_SIDED|95.0|0.847|2.291|||Log Rank|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.|Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.291|0.847|0.189
71644292|NCT02213263|142806602|SUPERIORITY||Mean Difference (Final Values)|-2.31|||||TWO_SIDED|95.0|-11.09|6.5||||||Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.||6.50|-11.09|
71644293|NCT02213263|142806603|SUPERIORITY||Hazard Ratio (HR)|1.492||||0.185|TWO_SIDED|95.0|0.823|2.704||A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.|||2.704|0.823|0.185
71644294|NCT02213263|142806604|SUPERIORITY||Hazard Ratio (HR)|2.94||||0.319|TWO_SIDED|95.0|0.0||Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||||0.000|0.319
71644295|NCT02336074|142806659|SUPERIORITY|||||||0.26||||||Treatment arms were compared in terms of absolute total HIV DNA levels (on a log10-scale) at post-randomization weeks 16 and 18 adjusted for the baseline (i.e. randomization) level and by stratum.|Regression, Linear|||||||0.26
71644296|NCT02336074|142806661|SUPERIORITY||Odds Ratio (OR)|0.41||||0.145|TWO_SIDED||||||Regression, Logistic|||"Comparison of the proportion of patients with undetectable viral outgrowth using logistic regression.~The analysis was adjusted for stratum and baseline viral outgrowth. Missing baseline values were imputed."||||0.145
71823813|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-2.73|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.67|-1.79|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.79|-3.67|< 0.0001
71823814|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.48||0.0509|TWO_SIDED|95.0|-1.89|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-1.89|0.0509
71644297|NCT02679729|142806667|SUPERIORITY_OR_OTHER||Slope|0.625|||||TWO_SIDED|95.0|0.396|0.853||||||Statistical Analysis for Part A||0.853|0.396|
71644298|NCT02679729|142806668|SUPERIORITY_OR_OTHER||Slope|1.2|||||TWO_SIDED|95.0|0.905|1.49||||||Statistical Analysis for Part A||1.49|0.905|
71644299|NCT02679729|142806669|SUPERIORITY_OR_OTHER||Slope|1.55|||||TWO_SIDED|95.0|1.34|1.76||||||Statistical Analysis for Part A||1.76|1.34|
71644300|NCT04667338|142806683|SUPERIORITY||||||=|0.5061|||||||Chi-squared|||Pharmacological||||=0.5061
71644301|NCT04667338|142806683|SUPERIORITY||||||=|0.2053|||||||Chi-squared|||Non-pharmacological||||=0.2053
71644302|NCT04667338|142806684|SUPERIORITY||||||=|0.4016|||||||Chi-squared|||||||=0.4016
71644303|NCT04667338|142806687|SUPERIORITY||||||=|0.5274|||||||Chi-squared|||Educational level ongoing or completed level of education||||=0.5274
71644304|NCT04667338|142806687|SUPERIORITY||||||=|0.7051|||||||Chi-squared|||Occupational status and occupation||||=0.7051
71644305|NCT04667338|142806687|SUPERIORITY||||||=|0.3543|||||||Chi-squared|||Civil status||||=0.3543
71644306|NCT04667338|142806687|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Living conditions||||=0.0368
71644307|NCT04667338|142806687|SUPERIORITY||||||=|0.3512|||||||Chi-squared|||Smoking status||||=0.3512
71644308|NCT04667338|142806687|SUPERIORITY||||||=|0.104|||||||Chi-squared|||Alcohol intake||||=0.1040
71644309|NCT04667338|142806687|SUPERIORITY||||||=|0.0202|||||||Chi-squared|||Exercise status||||=0.0202
71644310|NCT04667338|142806687|SUPERIORITY||||||=|0.3503|||||||Chi-squared|||Family history of narcolepsy||||=0.3503
71644311|NCT04667338|142806692|SUPERIORITY||||||=|0.0715|||||||Chi-squared|||General practitioner||||=0.0715
71644312|NCT04667338|142806692|SUPERIORITY||||||=|0.0929|||||||Chi-squared|||Neurologist||||=0.0929
71644313|NCT04667338|142806692|SUPERIORITY||||||=|0.3092|||||||Chi-squared|||Neuropediatrician||||=0.3092
71644314|NCT04667338|142806692|SUPERIORITY||||||=|0.4528|||||||Chi-squared|||Neurophysiologist||||=0.4528
71644315|NCT04667338|142806692|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Pneumologist||||<0.0001
71644316|NCT04667338|142806692|SUPERIORITY||||||=|0.1785|||||||Chi-squared|||Somnologist||||=0.1785
71644317|NCT04667338|142806692|SUPERIORITY||||||=|0.1474|||||||Chi-squared|||Somnologist-unit||||=0.1474
71644318|NCT04667338|142806693|SUPERIORITY||||||=|0.2042|||||||Chi-squared|||Clinical history||||=0.2042
71644319|NCT04667338|142806693|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Clinical assessment: ESS||||=0.5818
71644320|NCT04667338|142806693|SUPERIORITY||||||=|0.0368|||||||Chi-squared|||Neurological assessment||||=0.0368
71644321|NCT04667338|142806693|SUPERIORITY||||||=|0.1128|||||||Chi-squared|||MSLT||||=0.1128
71644322|NCT04667338|142806693|SUPERIORITY||||||=|0.3396|||||||Chi-squared|||AHI||||=0.3396
71644323|NCT04667338|142806693|SUPERIORITY||||||=|0.6794|||||||Chi-squared|||Other procedures||||=0.6794
71644324|NCT04667338|142806693|SUPERIORITY||||||=|0.0138|||||||Chi-squared|||HLA typing||||=0.0138
71644325|NCT04667338|142806693|SUPERIORITY||||||=|0.0597|||||||Chi-squared|||Hypocretin-1 CSF or Orexin||||=0.0597
71644326|NCT04667338|142806694|SUPERIORITY||||||=|0.1171|||||||t-test, 2 sided|||||||=0.1171
71644327|NCT04667338|142806695|SUPERIORITY||||||=|0.3834|||||||t-test, 2 sided|||||||=0.3834
71644328|NCT04667338|142806700|SUPERIORITY||||||=|0.0531|||||||t-test, 2 sided|||||||=0.0531
71644329|NCT04667338|142806701|SUPERIORITY||||||=|0.0005|||||||Chi-squared|||Take short naps||||=0.0005
71644330|NCT04667338|142806701|SUPERIORITY||||||=|0.8221|||||||Chi-squared|||Maintain a regular sleep schedule||||=0.8221
71644331|NCT04667338|142806701|SUPERIORITY||||||=|0.2291|||||||Chi-squared|||Avoid caffeine or alcohol before bedtime||||=0.2291
71644332|NCT04667338|142806701|SUPERIORITY||||||=|0.9177|||||||Chi-squared|||Avoid smoking, especially at night||||=0.9177
71644333|NCT04667338|142806701|SUPERIORITY||||||=|0.4188|||||||Chi-squared|||Exercise daily||||=0.4188
71644334|NCT04667338|142806701|SUPERIORITY||||||=|0.5818|||||||Chi-squared|||Avoid large, heavy meals right before bedtime||||=0.5818
71644335|NCT04667338|142806701|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Other||||=0.5432
71644336|NCT04667338|142806702|SUPERIORITY||||||=|0.5432|||||||Chi-squared|||Treatment||||=0.5432
71644337|NCT04667338|142806702|SUPERIORITY||||||=|0.0397|||||||Chi-squared|||Routine monitoring visits||||=0.0397
71644338|NCT04667338|142806702|SUPERIORITY||||||=|0.0306|||||||Chi-squared|||Tests||||=0.0306
71644339|NCT04667338|142806702|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Emergency visits||||=0.7451
71644340|NCT04667338|142806702|SUPERIORITY||||||=|0.0845|||||||Chi-squared|||Hospitalizations||||=0.0845
71644341|NCT04667338|142806702|SUPERIORITY||||||=|0.3813|||||||Chi-squared|||Complications||||=0.3813
71644342|NCT04667338|142806704|SUPERIORITY||||||=|0.0034|||||||t-test, 2 sided|||Absenteeism||||=0.0034
71644343|NCT04667338|142806704|SUPERIORITY||||||=|0.2178|||||||t-test, 2 sided|||Presenteeism||||=0.2178
71644344|NCT04667338|142806704|SUPERIORITY||||||=|0.1758|||||||t-test, 2 sided|||Work productivity loss||||=0.1758
71644345|NCT04667338|142806704|SUPERIORITY||||||=|0.1789|||||||t-test, 2 sided|||Activity Impairment / disability||||=0.1789
71644346|NCT04667338|142806705|SUPERIORITY||||||=|0.5806|||||||Chi-squared|||||||=0.5806
71644347|NCT04667338|142806707|SUPERIORITY||||||=|0.1602|||||||Chi-squared|||Mobility||||=0.1602
71644348|NCT04667338|142806707|SUPERIORITY||||||=|0.5249|||||||Chi-squared|||Self-Care||||=0.5249
71644349|NCT04667338|142806707|SUPERIORITY||||||=|0.1095|||||||Chi-squared|||Usual activities||||=0.1095
71644350|NCT04667338|142806707|SUPERIORITY||||||=|0.3528|||||||Chi-squared|||Pain / Discomfort||||=0.3528
71644351|NCT04667338|142806707|SUPERIORITY||||||=|0.7434|||||||Chi-squared|||Anxiety / Depression||||=0.7434
71644352|NCT04667338|142806708|SUPERIORITY||||||=|0.0396|||||||t-test, 2 sided|||||||=0.0396
71823815|NCT00797225|143151325|SUPERIORITY||LS mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.48||0.0046|TWO_SIDED|95.0|-2.33|-0.43|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.43|-2.33|0.0046
71823816|NCT00797225|143151325|SUPERIORITY||LS Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.26|-1.38|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-1.38|-3.26|< 0.0001
71823817|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0453|TWO_SIDED|95.0|-0.33|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.33|0.0453
71823818|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0609|TWO_SIDED|95.0|-0.31|0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.01|-0.31|0.0609
71823819|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.0069|TWO_SIDED|95.0|-0.38|-0.06|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.06|-0.38|0.0069
71823820|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0556|TWO_SIDED|95.0|-0.32|0.0|||Mixed-effects Repeated Measures Model]|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.00|-0.32|0.0556
71644353|NCT04667338|142806709|SUPERIORITY||||||=|0.0394|||||||t-test, 2 sided|||Effectiveness||||=0.0394
71644354|NCT04667338|142806709|SUPERIORITY||||||=|0.3093|||||||t-test, 2 sided|||Convenience||||=0.3093
71823821|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.0387|TWO_SIDED|95.0|-0.33|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.01|-0.33|0.0387
71823822|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08||0.0008|TWO_SIDED|95.0|-0.44|-0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.12|-0.44|0.0008
71644355|NCT04667338|142806709|SUPERIORITY||||||=|0.2296|||||||t-test, 2 sided|||Global satisfaction||||=0.2296
71644356|NCT04667338|142806710|SUPERIORITY||||||=|0.1817|||||||Chi-squared|||Depression||||=0.1817
71644357|NCT04667338|142806710|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Bipolar disorder||||=0.0885
71886198|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0115|TWO_SIDED|95.0|-0.3|-0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Night-time||-0.04|-0.30|0.0115
71644358|NCT04667338|142806710|SUPERIORITY||||||=|0.3043|||||||Chi-squared|||Anxiety disorders||||=0.3043
71644359|NCT04667338|142806710|SUPERIORITY||||||=|0.0885|||||||Chi-squared|||Panic disorder||||=0.0885
71644360|NCT04667338|142806710|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Phobia disorder||||=0.5603
71644361|NCT04667338|142806710|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Obsessive compulsive disorder||||=0.5603
71644362|NCT04667338|142806710|SUPERIORITY||||||=|0.3646|||||||Chi-squared|||Diagnosis of ADHD||||=0.3646
71644363|NCT04667338|142806710|SUPERIORITY||||||=|0.2615|||||||Chi-squared|||Obesity||||=0.2615
71644364|NCT04667338|142806710|SUPERIORITY||||||=|0.3076|||||||Chi-squared|||Endocrine Disorders||||=0.3076
71644365|NCT04667338|142806710|SUPERIORITY||||||=|0.409|||||||Chi-squared|||Peripheral vascular disease||||=0.4090
71644366|NCT04667338|142806710|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Cardiovascular accident or transient ischemic attack (TIA)||||=0.5603
71644367|NCT04667338|142806710|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||COPD||||=0.5603
71644368|NCT04667338|142806710|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||Connective tissue disease||||=0.5603
71644369|NCT04667338|142806710|SUPERIORITY||||||=|0.7451|||||||Chi-squared|||Liver Disease||||=0.7451
71644370|NCT04667338|142806710|SUPERIORITY||||||=|0.3108|||||||Chi-squared|||Diabetes Mellitus||||=0.3108
71644371|NCT04667338|142806710|SUPERIORITY||||||=|0.2407|||||||Chi-squared|||Solid Tumor||||=0.2407
71644372|NCT04667338|142806710|SUPERIORITY||||||=|0.5603|||||||Chi-squared|||AIDS||||=0.5603
71644373|NCT04667338|142806710|SUPERIORITY||||||=|0.1739|||||||Chi-squared|||Others||||=0.1739
71644374|NCT04667338|142806711|SUPERIORITY||||||=|0.3585|||||||t-test, 2 sided|||||||=0.3585
71644375|NCT03488108|142806721|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
71644376|NCT03488108|142806722|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.90
71644377|NCT03488108|142806723|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
71644378|NCT03488108|142806724|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||.005
71644379|NCT03602339|142806730|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.455|||<|0.0001|TWO_SIDED|95.0|0.347|0.562||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.562|0.347|< 0.0001
71644380|NCT03602339|142806731|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.18|||=|0.0151|TWO_SIDED|95.0|0.017|0.342||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.342|0.017|= 0.0151
71644381|NCT03602339|142806732|NON_INFERIORITY|"The score to evaluate the non-inferiority is calculated for each subject as (combined unenhanced/gadobutrol-enhanced - unenhanced) - 0.8\*(combined unenhanced/gadoterate-enhanced - unenhanced). The 95% CI is based on a t-distribution. The non-inferiority for gadobutrol is achieved if the one-sided p-value for H0: (gadobutrol minus unenhanced) - 0.8\*(gadoterate minus unenhanced) ≤ 0 is lower than 0.025."|Mean Difference (Final Values)|0.15|||=|0.01|TWO_SIDED|95.0|0.024|0.275||No type I error adjustment for multiple comparisons is needed because tests on all 3 primary efficacy variables must be significant to demonstrate primary efficacy.|Paired t-test|||Difference (gadobutrol minus unenhanced) - (gadoterate minus unenhanced)||0.275|0.024|= 0.0100
71644382|NCT03602339|142806733|NON_INFERIORITY|Non-inferiority margin is 0.35. If the lower limit of the 95% CI is \> -0.35, then non-inferiority is achieved.|Mean Difference (Final Values)|0.073|||||TWO_SIDED|95.0|-0.03|0.176||||||Difference (Gadobutrol - Gadoterate)||0.176|-0.030|
71644383|NCT03602339|142806734|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-3.4|3.4|||||The 95% confidence intervals are based on McNemar's test.|Accuracy Difference (Gadobutrol - Gadoterate)||3.40|-3.40|
71644384|NCT03602339|142806734|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|-5.22|5.22|||||The 95% confidence intervals are based on McNemar's test.|Sensitivity Difference (Gadobutrol - Gadoterate)||5.22|-5.22|
71644385|NCT03602339|142806734|NON_INFERIORITY|Non-inferiority margin = 10%, if the lower limit of the confidence interval \> -10%, then non-inferiority is achieved.|Difference (Gadobutrol - Gadoterate)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The 95% confidence intervals are based on McNemar's test. No continuity correction for calculation of the confidence interval was included. Zero cells lead to degenerated confidence interval.|Specificity Difference (Gadobutrol - Gadoterate)||0.00|0.00|
71644386|NCT03602339|142806735|OTHER||Mean Difference (Final Values)|0.076|||||TWO_SIDED|95.0|0.011|0.14||||||Difference (Gadobutrol - Gadoterate)||0.140|0.011|
71644387|NCT03602339|142806736|OTHER||Mean Difference (Final Values)|0.0||||0.9149|TWO_SIDED|95.0|-0.1|0.11|||Wilcoxon signed-rank test|||Comparison of image quality between gadobutrol and gadoterate||0.11|-0.10|0.9149
71762710|NCT02785770|143027144|SUPERIORITY_OR_OTHER||LS mean difference|-1.34||||0.2892|TWO_SIDED|90.0|-3.43|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.74|-3.43|0.2892
71644388|NCT03602339|142806737|OTHER||Mean Difference (Final Values)|-0.01968|||||TWO_SIDED|95.0|-0.03491|-0.00445||||||Difference (Gadobutrol-Gadoterate) for Relative score||-0.00445|-0.03491|
71644389|NCT03602339|142806737|OTHER||Mean Difference (Final Values)|0.00586|||||TWO_SIDED|95.0|-0.00589|0.01762||||||Difference (Gadobutrol-Gadoterate) for Full image score||0.01762|-0.00589|
71644390|NCT03602339|142806737|OTHER||Mean Difference (Final Values)|0.00139|||||TWO_SIDED|95.0|-0.00471|0.00749||||||Difference (Gadobutrol-Gadoterate) for Dice score||0.00749|-0.00471|
71644391|NCT03602339|142806739|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate), and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0049||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0049
71644392|NCT03602339|142806740|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0013||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0013
71644393|NCT03602339|142806741|EQUIVALENCE|An equivalence test was calculated using the two one-sided t-tests (TOST) procedure with null hypotheses H01: (gadobutrol - gadoterate) ≤ -0.05 \* (gadoterate) and H02: (gadobutrol - gadoterate) ≥ +0.05 \* (gadoterate).||||||0.0065||||||The overall p-value was calculated as max(p1, p2) where p1 and p2 are the results of null hypotheses H01 and H02 respectively.|Two one-sided t-tests (TOST)|||||||0.0065
71644394|NCT00834275|142806769|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|94.0|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|94|
71644395|NCT00834275|142806770|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|98.3|
71644396|NCT00834275|142806771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||104|98.3|
71644397|NCT00829764|142806772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|93.52||||||90.0|88.49|98.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||98.83|88.49|
71644398|NCT00829764|142806773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.75||||||90.0|93.98|101.67|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.67|93.98|
71644399|NCT00829764|142806774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.46||||||90.0|94.78|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102.28|94.78|
71644400|NCT05523895|142806841|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.52||0.2986|TWO_SIDED|95.0|-4.6|1.4|||Mixed Models Analysis|||||1.4|-4.6|0.2986
71644401|NCT05523895|142806841|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.49||0.2859|TWO_SIDED|95.0|-4.5|1.3|||Mixed Models Analysis|||||1.3|-4.5|0.2859
71644402|NCT03779334|142806863|SUPERIORITY||||||<|0.0001|||||||Exact Binomial Test|Performance Criterion = 5%||||||<0.0001
71823823|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5879|TWO_SIDED|95.0|-0.21|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.21|0.5879
71644403|NCT01175135|142806891|OTHER||Least Squares (LS) Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|2.683||0.2053|TWO_SIDED|80.0|-5.66|1.24||Reported p-value was 1-sided.|Mixed Models Analysis|||Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.24|-5.66|0.2053
71644404|NCT01175135|142806891|OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|2.698||0.4024|TWO_SIDED|80.0|-4.14|2.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||2.80|-4.14|0.4024
71644405|NCT01175135|142806891|OTHER||LS Mean Difference|-8.24|STANDARD_ERROR_OF_MEAN|3.453||0.009|TWO_SIDED|80.0|-12.68|-3.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-3.80|-12.68|0.0090
71644406|NCT01175135|142806892|OTHER||Difference in Proportion|-0.03|||||TWO_SIDED|80.0|-0.07|0.01|||||The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.|||0.01|-0.07|
71644407|NCT01175135|142806892|OTHER||Difference in Proportion|0.04|||||TWO_SIDED|80.0|-0.02|0.1|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||0.10|-0.02|
71644408|NCT01175135|142806892|OTHER||Difference in Proportion|-0.04|||||TWO_SIDED|80.0|-0.08|0.0|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.|||-0.00|-0.08|
71644409|NCT01175135|142806893|OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.845||0.3144|TWO_SIDED|80.0|-1.5|0.68||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.68|-1.50|0.3144
71660938|NCT03118570|142835401|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.204||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.204
71644410|NCT01175135|142806893|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.854||0.57|TWO_SIDED|80.0|-0.95|1.25||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.25|-0.95|0.5700
71823824|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6122|TWO_SIDED|95.0|-0.2|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.12|-0.20|0.6122
71644411|NCT01175135|142806893|OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.093||0.0034|TWO_SIDED|80.0|-4.4|-1.59||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.59|-4.40|0.0034
71644412|NCT01175135|142806893|OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.73||0.0942|TWO_SIDED|80.0|-1.9|-0.02||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.02|-1.90|0.0942
71644413|NCT01175135|142806893|OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.735||0.203|TWO_SIDED|80.0|-1.56|0.33||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.33|-1.56|0.2030
71644414|NCT01175135|142806893|OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.944||0.0907|TWO_SIDED|80.0|-2.48|-0.05||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-0.05|-2.48|0.0907
71644415|NCT01175135|142806893|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|1.33||0.2904|TWO_SIDED|80.0|-2.45|0.97||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||0.97|-2.45|0.2904
71644416|NCT01175135|142806893|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.339||0.471|TWO_SIDED|80.0|-1.82|1.62||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||1.62|-1.82|0.4710
71644417|NCT01175135|142806893|OTHER||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.718||0.0172|TWO_SIDED|80.0|-5.86|-1.45||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.||-1.45|-5.86|0.0172
71644418|NCT01175135|142806894|OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.154||0.197|TWO_SIDED|80.0|-0.33|0.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.07|-0.33|0.1970
71644419|NCT01175135|142806894|OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.154||0.3835|TWO_SIDED|80.0|-0.24|0.15||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.15|-0.24|0.3835
71644420|NCT01175135|142806894|OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.199||0.0395|TWO_SIDED|80.0|-0.61|-0.1||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.10|-0.61|0.0395
71644421|NCT01175135|142806895|OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.863||0.1999|TWO_SIDED|80.0|-1.84|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.84|0.1999
71644422|NCT01175135|142806895|OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.87||0.3399|TWO_SIDED|80.0|-1.48|0.76||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.76|-1.48|0.3399
71823825|NCT00797225|143151326|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.0023|TWO_SIDED|95.0|-0.41|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.09|-0.41|0.0023
71644423|NCT01175135|142806895|OTHER||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|1.117||0.01|TWO_SIDED|80.0|-4.06|-1.18||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.18|-4.06|0.0100
71644424|NCT01175135|142806895|OTHER||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.778||0.1625|TWO_SIDED|80.0|-1.77|0.23||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.23|-1.77|0.1625
71644425|NCT01175135|142806895|OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.783||0.2354|TWO_SIDED|80.0|-1.57|0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.44|-1.57|0.2354
71644426|NCT01175135|142806895|OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.002||0.2161|TWO_SIDED|80.0|-2.08|0.5||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.50|-2.08|0.2161
71644427|NCT01175135|142806895|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.627||0.248|TWO_SIDED|80.0|-1.23|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.23|0.2480
71644428|NCT01175135|142806895|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.632||0.4345|TWO_SIDED|80.0|-0.92|0.71||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.71|-0.92|0.4345
71644429|NCT01175135|142806895|OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.813||0.0346|TWO_SIDED|80.0|-2.53|-0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.44|-2.53|0.0346
71644430|NCT01175135|142806895|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.495||0.4685|TWO_SIDED|80.0|-0.68|0.6||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.60|-0.68|0.4685
71644431|NCT01175135|142806895|OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.499||0.6214|TWO_SIDED|80.0|-0.49|0.8||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.80|-0.49|0.6214
71644432|NCT01175135|142806895|OTHER||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.641||0.0052|TWO_SIDED|80.0|-2.48|-0.84||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.84|-2.48|0.0052
71644433|NCT01175135|142806895|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.523||0.5894|TWO_SIDED|80.0|-0.55|0.79||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.79|-0.55|0.5894
71644434|NCT01175135|142806895|OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.526||0.8155|TWO_SIDED|80.0|-0.2|1.15||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||1.15|-0.20|0.8155
71644435|NCT01175135|142806895|OTHER||LS Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.677||0.0069|TWO_SIDED|80.0|-2.55|-0.81||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.81|-2.55|0.0069
71644436|NCT01175135|142806896|OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.559||0.2727|TWO_SIDED|80.0|-1.06|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.38|-1.06|0.2727
71644437|NCT01175135|142806896|OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.562||0.4747|TWO_SIDED|80.0|-0.76|0.69||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||0.69|-0.76|0.4747
71644438|NCT01175135|142806896|OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.723||0.0031|TWO_SIDED|80.0|-2.93|-1.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.||-1.07|-2.93|0.0031
71644439|NCT01175135|142806897|OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.196||0.3598|TWO_SIDED|80.0|-0.32|0.18||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.18|-0.32|0.3598
71644440|NCT01175135|142806897|OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.198||0.7275|TWO_SIDED|80.0|-0.13|0.37||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||0.37|-0.13|0.7275
71644441|NCT01175135|142806897|OTHER||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.255||0.0019|TWO_SIDED|80.0|-1.07|-0.42||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||-0.42|-1.07|0.0019
71644442|NCT01175135|142806898|OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.478||0.5429|TWO_SIDED|80.0|-2.06|1.74||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||1.74|-2.06|0.5429
71644443|NCT01175135|142806898|OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|1.492||0.4354|TWO_SIDED|80.0|-1.68|2.16||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||2.16|-1.68|0.4354
71644444|NCT01175135|142806898|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|1.907||0.093|TWO_SIDED|80.0|0.08|4.99||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.||4.99|0.08|0.0930
71762711|NCT02785770|143027144|SUPERIORITY_OR_OTHER||LS mean difference|-2.78||||0.0294|TWO_SIDED|90.0|-4.88|-0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.68|-4.88|0.0294
71644445|NCT05283148|142806922|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.321||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the lumbar spine. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.321
71644446|NCT05283148|142806923|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.714||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA lumbar spine scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.714
71644447|NCT05283148|142806924|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.09||||||p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the total hip. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.09
71644448|NCT05283148|142806925|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.604||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA total hip scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.604
71644449|NCT05283148|142806926|OTHER|Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used.||||||0.013||||||A p-value \< 0.05 was considered statistically significant.|Wilcoxon rank-sum test (two-sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (full range) for each group, measured by DXA at the femoral neck. Distribution was non-normal, so a Wilcoxon rank-sum test (two-sided) was used. A p-value \< 0.05 was considered statistically significant.||||0.013
71762712|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|1.28||||0.16|TWO_SIDED|90.0|-0.22|2.78|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.78|-0.22|0.1600
71660939|NCT03118570|142835402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.588||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.588
71886199|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1772|TWO_SIDED|95.0|-0.22|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Night-time||0.04|-0.22|0.1772
71644450|NCT05283148|142806927|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.166||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test|||Comparison between Group A and Group B as defined above. Values are reported as median ± full range for each group, derived from DXA femoral neck scans. Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.166
71644451|NCT05283148|142806928|OTHER|Welch two-sample t-test (two-sided) was used to account for unequal variances.||||||0.23||||||A p-value \< 0.05 was considered statistically significant.|Welch two sample t-test (two sided)|||Comparison between Group A and Group B as defined above. Values are reported as median (interquartile range) for each group, based on the ASCQ-Me Pain Impact instrument (lower scores indicate worse pain impact). Welch two-sample t-test (two-sided) was used to account for unequal variances. A p-value \< 0.05 was considered statistically significant.||||0.23
71644452|NCT00095784|142806937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CD34+ cell levels. Analysis performed on log scale.||||<0.0001
71644453|NCT00095784|142806943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CXCR4 levels. Analysis performed on log scale.||||0.29
71644454|NCT00095784|142806949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in hemoglobin F levels.||||0.99
71644455|NCT03325881|142806984|SUPERIORITY||Difference in LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|2.48||0.451|TWO_SIDED|95.0|-6.8|3.1|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the linear mixed-effects model for repeated measures (MMRM) that included treatment group, nominal visit, age group, interaction of the treatment group with the visits as factors, baseline ADHD-RS5 total score as a covariate and an adjustment for the interaction of the baseline ADHD-RS-5 Total Score with the visit.||3.1|-6.8|0.451
71644456|NCT03325881|142806985|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.597|TWO_SIDED|95.0|-0.5|0.3|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, age group,interaction of the treatment group with the visit as factors, baseline CGI-S as a covariate and an adjustment for the interaction of the baseline CGI-S with the visit.||0.3|-0.5|0.597
71644457|NCT03676634|142806995|OTHER||single proportion|0.844|||||TWO_SIDED|95.0|0.672|0.947|||||Values listed in table are for Type A. Estimated Value for the Estimation Parameter for type B = 0.875. Lower limit = 0.710, upper limit = 0.965|Consider increase from baseline to post-dose values. Parameter is proportion achieving desired increase (≥ 3x or 4x increase in Type A and Type B NAC).|Proportion of participants achieving ≥ 3x or 4x increase in NAC values was calculated for both Type A and Type B. Primary endpoint was achieved if both Type A and Type B had proportion ≥50%.|.947|.672|
71644458|NCT03060486|142807001|OTHER||Signed Rank Score Difference|-60.0|||<|0.0001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<.0001
71644459|NCT02052895|142807002|SUPERIORITY_OR_OTHER||Difference of ROC-AUC|0.0317||||0.3924|TWO_SIDED|95.0|-0.0409|0.1043|||Regression, Logistic|||||0.1043|-0.0409|0.3924
71644460|NCT00540423|142807009|SUPERIORITY_OR_OTHER||Risk Difference (RD)|60.0||||||95.0|35.21|84.79|||||The units of risk difference is percentage.|||84.79|35.21|
71644461|NCT00540423|142807011|SUPERIORITY_OR_OTHER||Percentage of 75% responders|43.5||||||95.0|23.19|65.51|||||Confidence interval of the percentage of participants for whom at least 75% of their assessments during the course of 26 weeks of SB-494115-GR treatment met the definition of responders.|||65.51|23.19|
71644462|NCT03131895|142807033|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) confidence intervals (CIs) on the original scale.|Least square (LS) mean ratio|1.0436||||0.5535|TWO_SIDED|90.0|0.9453|1.1521|||ANOVA|||||1.1521|0.9453|0.5535
71823826|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.69|< 0.0001
71644463|NCT03131895|142807033|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0185||||0.892|TWO_SIDED|90.0|0.9334|1.1113|||ANOVA|||||1.1113|0.9334|0.8920
71644464|NCT03131895|142807034|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.039||||0.3209|TWO_SIDED|90.0|0.9792|1.1024|||ANOVA|||||1.1024|0.9792|0.3209
71644465|NCT03131895|142807034|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0353||||0.3896|TWO_SIDED|90.0|0.9719|1.1029|||ANOVA|||||1.1029|0.9719|0.3896
71644466|NCT03131895|142807035|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0335||||0.4163|TWO_SIDED|90.0|0.9733|1.0975|||ANOVA|||||1.0975|0.9733|0.4163
71644467|NCT03131895|142807035|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0031||||0.9778|TWO_SIDED|90.0|0.9458|1.0638|||ANOVA|||||1.0638|0.9458|0.9778
71644468|NCT05143047|142807066|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71644469|NCT05143047|142807067|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71644470|NCT05143047|142807068|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71644471|NCT05143047|142807069|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71644472|NCT05143047|142807070|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71644473|NCT05143047|142807071|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71644474|NCT05143047|142807072|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
71644475|NCT05143047|142807073|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71644476|NCT05143047|142807074|SUPERIORITY|||||||0.22|||||||Fisher Exact|||||||0.22
71644477|NCT00909753|142807085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.5||||||90.0|85.8|99.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.7|85.8|
71644478|NCT00909753|142807086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.5||||||90.0|92.2|98.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.9|92.2|
71644479|NCT00909753|142807087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.3|83.1|
71644480|NCT00909753|142807088|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.5|95.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.9|85.5|
71644481|NCT00909753|142807089|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.5|99.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.5|85.5|
71644482|NCT00909753|142807090|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.0||||||90.0|91.3|98.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||98.7|91.3|
71644483|NCT00909753|142807091|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% COnfidence Interval falls within 80-125.|||98.3|83.1|
71644484|NCT00909753|142807092|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.0|96.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.3|85.0|
71644485|NCT03214588|142807104|SUPERIORITY||Least Squares Mean Difference|-0.00054|STANDARD_ERROR_OF_MEAN|0.000746|>|0.999|TWO_SIDED|90.0|-0.00179|0.0007||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00070|-0.00179|>0.999
71644486|NCT03214588|142807104|SUPERIORITY||Least Squares Mean Difference|-0.00069|STANDARD_ERROR_OF_MEAN|0.000616|>|0.999|TWO_SIDED|90.0|-0.00172|0.00033||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.00033|-0.00172|>0.999
71644487|NCT03214588|142807105|SUPERIORITY||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.782||0.135|TWO_SIDED|90.0|-2.18|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.44|-2.18|0.135
71644488|NCT03214588|142807105|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.64||0.818|TWO_SIDED|90.0|-0.48|1.66||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.66|-0.48|0.818
71644489|NCT03214588|142807105|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.77||0.591|TWO_SIDED|90.0|-1.11|1.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.47|-1.11|0.591
71644490|NCT03214588|142807105|SUPERIORITY||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.643||0.713|TWO_SIDED|90.0|-0.71|1.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.44|-0.71|0.713
71644491|NCT03214588|142807105|SUPERIORITY||Least Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.822||0.616|TWO_SIDED|90.0|-1.13|1.62||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.62|-1.13|0.616
71644492|NCT03214588|142807105|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.679||0.708|TWO_SIDED|90.0|-0.76|1.51||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.51|-0.76|0.708
71644493|NCT03214588|142807106|SUPERIORITY||Least Squares Mean Difference|-0.00039|STANDARD_ERROR_OF_MEAN|0.000604||0.741|TWO_SIDED|90.0|-0.0014|0.00062||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.00062|-0.00140|0.741
71644494|NCT03214588|142807106|SUPERIORITY||Least Squares Mean Difference|-0.00093|STANDARD_ERROR_OF_MEAN|0.000505||0.964|TWO_SIDED|90.0|-0.00177|-0.00008||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.00008|-0.00177|0.964
71886200|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6895|TWO_SIDED|95.0|-0.18|0.27|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Night-time||0.27|-0.18|0.6895
71644495|NCT03214588|142807106|SUPERIORITY||Least Squares Mean Difference|-0.00014|STANDARD_ERROR_OF_MEAN|0.000772||0.573|TWO_SIDED|90.0|-0.00143|0.00115||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00115|-0.00143|0.573
71644496|NCT03214588|142807106|SUPERIORITY||Least Squares Mean Difference|-0.00044|STANDARD_ERROR_OF_MEAN|0.000646||0.749|TWO_SIDED|90.0|-0.00152|0.00064||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.00064|-0.00152|0.749
71644497|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.154||0.571|TWO_SIDED|90.0|-0.23|0.29||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.29|-0.23|0.571
71644498|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.126||0.963|TWO_SIDED|90.0|0.02|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils||0.44|0.02|0.963
71644499|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.165||0.515|TWO_SIDED|90.0|-0.27|0.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.28|-0.27|0.515
71644500|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.138||0.986|TWO_SIDED|90.0|0.08|0.54||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils||0.54|0.08|0.986
71644501|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.162||0.718|TWO_SIDED|90.0|-0.18|0.37||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.37|-0.18|0.718
71644502|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.133||0.986|TWO_SIDED|90.0|0.08|0.52||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils||0.52|0.08|0.986
71644503|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.153|TWO_SIDED|90.0|-0.4|0.09||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.09|-0.40|0.153
71644504|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.119||0.861|TWO_SIDED|90.0|-0.07|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing||0.33|-0.07|0.861
71644505|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.443|TWO_SIDED|90.0|-0.22|0.18||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.18|-0.22|0.443
71644506|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.359|TWO_SIDED|90.0|-0.2|0.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing||0.13|-0.20|0.359
71644507|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.157||0.268|TWO_SIDED|90.0|-0.36|0.17||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.17|-0.36|0.268
71660940|NCT03118570|142835402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.697||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.697
71823827|NCT00797225|143151327|SUPERIORITY||LS mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.73|-0.27|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.27|-0.73|< 0.0001
71823828|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.25|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.25|-0.71|< 0.0001
71823829|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.23|-0.69|< 0.0001
71823830|NCT00797225|143151327|SUPERIORITY||LS mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.87|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.40|-0.87|< 0.0001
71823831|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.59|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.59|-1.04|< 0.0001
71823832|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.65|-0.18|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.18|-0.65|0.0005
71823833|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.76|-0.29|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.29|-0.76|< 0.0001
71823834|NCT00797225|143151327|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.56|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.56|-1.02|< 0.0001
71823835|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0011|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0011
71823836|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.13|-0.51|0.0010
71823837|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.57|-0.19|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.19|-0.57|< 0.0001
71823838|NCT00797225|143151328|SUPERIORITY||-0.33|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.0007|TWO_SIDED|95.0|-0.52|-0.14|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.14|-0.52|0.0007
71886201|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.21|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|Over 24 hours||-0.21|-0.84|0.0013
71644508|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.411|TWO_SIDED|90.0|-0.24|0.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing||0.19|-0.24|0.411
71644509|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.358|TWO_SIDED|90.0|-0.31|0.2||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.20|-0.31|0.358
71644510|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.123||0.946|TWO_SIDED|90.0|0.0|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene||0.41|0.00|0.946
71644511|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.193||0.505|TWO_SIDED|90.0|-0.32|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.32|0.505
71644512|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.158||0.658|TWO_SIDED|90.0|-0.2|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene||0.33|-0.20|0.658
71644513|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.184||0.649|TWO_SIDED|90.0|-0.24|0.38||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.38|-0.24|0.649
71644514|NCT03214588|142807107|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.661|TWO_SIDED|90.0|-0.19|0.32||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene||0.32|-0.19|0.661
71644515|NCT03214588|142807108|SUPERIORITY||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|1.078||0.992|TWO_SIDED|90.0|0.86|4.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.47|0.86|0.992
71644516|NCT03214588|142807108|SUPERIORITY||Least Squares Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|0.892||0.999|TWO_SIDED|90.0|1.29|4.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.28|1.29|0.999
71644517|NCT03214588|142807108|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.338||0.616|TWO_SIDED|90.0|-1.84|2.64||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.64|-1.84|0.616
71644518|NCT03214588|142807108|SUPERIORITY||Least Squares Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.131||0.823|TWO_SIDED|90.0|-0.83|2.95||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.95|-0.83|0.823
71644519|NCT03214588|142807108|SUPERIORITY||Least Squares Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|1.266||0.942|TWO_SIDED|90.0|-0.1|4.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.13|-0.10|0.942
71644520|NCT03214588|142807108|SUPERIORITY||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|1.053||0.975|TWO_SIDED|90.0|0.35|3.87||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||3.87|0.35|0.975
71644521|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.15|0.29||||||Change at Week 2, Bulbar||0.29|-0.15|
71886202|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.78|-0.15|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|Over 24 hours||-0.15|-0.78|0.0040
71644522|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.12|0.25||||||Change at Week 2, Bulbar||0.25|-0.12|
71644523|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.3|0.11||||||Change at Week 7, Bulbar||0.11|-0.30|
71644524|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.02|0.33||||||Change at Week 7, Bulbar||0.33|-0.02|
71644525|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.19|0.28||||||Change at Week 12, Bulbar||0.28|-0.19|
71644526|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|0.0|0.4||||||Change at Week 12, Bulbar||0.40|0.00|
71644527|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.689|||TWO_SIDED|90.0|0.83|3.14||||||Change at Week 2, Upper Limb Coordination||3.14|0.83|
71644528|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|90.0|0.06|1.97||||||Change at Week 2, Upper Limb Coordination||1.97|0.06|
71644529|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.882|||TWO_SIDED|90.0|-0.4|2.55||||||Change at Week 7, Upper Limb Coordination||2.55|-0.40|
71644530|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.743|||TWO_SIDED|90.0|-1.06|1.43||||||Change at Week 7, Upper Limb Coordination||1.43|-1.06|
71644531|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|-0.48|2.91||||||Change at Week 12, Upper Limb Coordination||2.91|-0.48|
71644532|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-0.87|1.94||||||Change at Week 12, Upper Limb Coordination||1.94|-0.87|
71644533|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|90.0|-0.41|1.2||||||Change at Week 2, Lower Limb Coordination||1.20|-0.41|
71644534|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|90.0|0.12|1.45||||||Change at Week 2, Lower Limb Coordination||1.45|0.12|
71644535|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.837|||TWO_SIDED|90.0|-1.44|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.44|
71644536|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.707|||TWO_SIDED|90.0|-1.01|1.36||||||Change at Week 7, Lower Limb Coordination||1.36|-1.01|
71644537|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.755|||TWO_SIDED|90.0|-0.27|2.25||||||Change at Week 12, Lower Limb Coordination||2.25|-0.27|
71644538|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.95|STANDARD_ERROR_OF_MEAN|0.626|||TWO_SIDED|90.0|-0.09|2.0||||||Change at Week 12, Lower Limb Coordination||2.00|-0.09|
71644539|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-0.8|1.3||||||Change at Week 2, Upright Stability||1.3|-0.8|
71644540|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|0.1|1.9||||||Change at Week 2, Upright Stability||1.9|0.1|
71644541|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.3|0.2||||||Change at Week 7, Upright Stability||0.2|-1.3|
71644542|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|0.0|1.2||||||Change at Week 7, Upright Stability||1.2|0.0|
71644543|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|90.0|-1.2|0.7||||||Change at Week 12, Upright Stability||0.7|-1.2|
71644544|NCT03214588|142807109|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.3|1.3||||||Change at Week 12, Upright Stability||1.3|-0.3|
71644545|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|90.0|-0.13|0.15||||||Change at Week 2, Cough||0.15|-0.13|
71644546|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|90.0|-0.11|0.12||||||Change at Week 2, Cough||0.12|-0.11|
71886203|NCT00662792|143292992|SUPERIORITY||Difference of adjusted means|0.16|STANDARD_ERROR_OF_MEAN|0.16||0.3287|TWO_SIDED|95.0|-0.16|0.48|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|Over 24 hours||0.48|-0.16|0.3287
71644547|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Cough||0.11|-0.24|
71644548|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|90.0|-0.05|0.25||||||Change at Week 7, Cough||0.25|-0.05|
71644549|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|-0.11|0.25||||||Change at Week 12, Cough||0.25|-0.11|
71644550|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|90.0|-0.03|0.26||||||Change at Week 12, Cough||0.26|-0.03|
71644551|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.09|0.25||||||Change at Week 2, Speech||0.25|-0.09|
71644552|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.04|0.24||||||Change at Week 2, Speech||0.24|-0.04|
71644553|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|90.0|-0.16|0.08||||||Change at Week 7, Speech||0.08|-0.16|
71644554|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.03|0.17||||||Change at Week 7, Speech||0.17|-0.03|
71644555|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.095|||TWO_SIDED|90.0|-0.16|0.16||||||Change at Week 12, Speech||0.16|-0.16|
71644556|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|90.0|-0.04|0.22||||||Change at Week 12, Speech||0.22|-0.04|
71644557|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|-0.14|0.29||||||Change at Week 2, Right Finger to Finger Test||0.29|-0.14|
71644558|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|90.0|-0.22|0.14||||||Change at Week 2, Right Finger to Finger Test||0.14|-0.22|
71644559|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|90.0|-0.13|0.28||||||Change at Week 7, Right Finger to Finger Test||0.28|-0.13|
71644560|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|90.0|-0.24|0.11||||||Change at Week 7, Right Finger to Finger Test||0.11|-0.24|
71644561|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126|||TWO_SIDED|90.0|-0.3|0.12||||||Change at Week 12, Right Finger to Finger Test||0.12|-0.30|
71644562|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.32|0.03||||||Change at Week 12, Right Finger to Finger Test||0.03|-0.32|
71644563|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|90.0|-0.15|0.33||||||Change at Week 2, Left Finger to Finger Test||0.33|-0.15|
71644564|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|90.0|-0.16|0.23||||||Change at Week 2, Left Finger to Finger Test||0.23|-0.16|
71644565|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|90.0|-0.18|0.23||||||Change at Week 7, Left Finger to Finger Test||0.23|-0.18|
71644566|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|-0.15|0.2||||||Change at Week 7, Left Finger to Finger Test||0.20|-0.15|
71644567|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|90.0|-0.17|0.36||||||Change at Week 12, Left Finger to Finger Test||0.36|-0.17|
71644568|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.13||||||Change at Week 12, Left Finger to Finger Test||0.13|-0.30|
71644569|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.04|0.53||||||Change at Week 2, Right Nose to Finger Test||0.53|0.04|
71644570|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|90.0|-0.06|0.33||||||Change at Week 2, Right Nose to Finger Test||0.33|-0.06|
71644571|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.22|0.37||||||Change at Week 7, Right Nose to Finger Test||0.37|-0.22|
71644572|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|90.0|-0.32|0.16||||||Change at Week 7, Right Nose to Finger Test||0.16|-0.32|
71644573|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.43|0.12||||||Change at Week 12, Right Nose to Finger Test||0.12|-0.43|
71644574|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.23|0.23||||||Change at Week 12, Right Nose to Finger Test||0.23|-0.23|
71644575|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.14|0.4||||||Change at Week 2, Left Nose to Finger Test||0.40|-0.14|
71644576|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|-0.12|0.33||||||Change at Week 2, Left Nose to Finger Test||0.33|-0.12|
71644577|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|90.0|-0.09|0.43||||||Change at Week 7, Left Nose to Finger Test||0.43|-0.09|
71644578|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|90.0|-0.36|0.09||||||Change at Week 7, Left Nose to Finger Test||0.09|-0.36|
71644579|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|90.0|-0.29|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.29|
71644580|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.21|0.27||||||Change at Week 12, Left Nose to Finger Test||0.27|-0.21|
71644581|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.33|0.26||||||Change at Week 2, Right Dysmetria Test||0.26|-0.33|
71644582|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|-0.12|0.36||||||Change at Week 2, Right Dysmetria Test||0.36|-0.12|
71644583|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.25|0.48||||||Change at Week 7, Right Dysmetria Test||0.48|-0.25|
71644584|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.14|0.47||||||Change at Week 7, Right Dysmetria Test||0.47|-0.14|
71644585|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.26|0.48||||||Change at Week 12, Right Dysmetria Test||0.48|-0.26|
71644586|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.36|0.25||||||Change at Week 12, Right Dysmetria Test||0.25|-0.36|
71644587|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.185|||TWO_SIDED|90.0|-0.02|0.6||||||Change at Week 2, Left Dysmetria Test||0.60|-0.02|
71644588|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.1|0.41||||||Change at Week 2, Left Dysmetria Test||0.41|-0.10|
71644589|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|90.0|-0.63|0.13||||||Change at Week 7, Left Dysmetria Test||0.13|-0.63|
71644590|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.192|||TWO_SIDED|90.0|-0.47|0.18||||||Change at Week 7, Left Dysmetria Test||0.18|-0.47|
71644591|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.37|0.48||||||Change at Week 12, Left Dysmetria Test||0.48|-0.37|
71644592|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.11|0.58||||||Change at Week 12, Left Dysmetria Test||0.58|-0.11|
71644593|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.06|0.51||||||Change at Week 2, RAM of Right Hands||0.51|-0.06|
71644594|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.12|0.35||||||Change at Week 2, RAM of Right Hands||0.35|-0.12|
71644595|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|-0.41|0.28||||||Change at Week 7, RAM of Right Hands||0.28|-0.41|
71644596|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.172|||TWO_SIDED|90.0|-0.29|0.29||||||Change at Week 7, RAM of Right Hands||0.29|-0.29|
71644597|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.12|0.51||||||Change at Week 12, RAM of Right Hands||0.51|-0.12|
71644598|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.156|||TWO_SIDED|90.0|-0.31|0.21||||||Change at Week 12, RAM of Right Hands||0.21|-0.31|
71644599|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|90.0|-0.15|0.32||||||Change at Week 2, RAM of Left Hands||0.32|-0.15|
71644600|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.12|0.27||||||Change at Week 2, RAM of Left Hands||0.27|-0.12|
71644601|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.27|0.43||||||Change at Week 7, RAM of Left Hands||0.43|-0.27|
71644602|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.17|0.42||||||Change at Week 7, RAM of Left Hands||0.42|-0.17|
71644603|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|90.0|0.04|0.58||||||Change at Week 12, RAM of Left Hand||0.58|0.04|
71644604|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|90.0|-0.01|0.43||||||Change at Week 12, RAM of Left Hand||0.43|-0.01|
71644605|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|90.0|0.1|0.77||||||Change at Week 2, Right Finger Taps||0.77|0.10|
71823839|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.62|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.24|-0.62|< 0.0001
71823840|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.73|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.35|-0.73|< 0.0001
71823841|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.1319|TWO_SIDED|95.0|-0.34|0.04|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||0.04|-0.34|0.1319
71823842|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.0222|TWO_SIDED|95.0|-0.42|-0.03|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.03|-0.42|0.0222
71823843|NCT00797225|143151328|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.66|-0.28|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.||-0.28|-0.66|< 0.0001
71823844|NCT01928940|143151361|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
71823845|NCT01928940|143151361|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
71823846|NCT01928940|143151366|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
71823847|NCT01928940|143151366|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|82.2|||Exact binomial test||BICR Assessed ORR|||82.2|11.8|0.0158
71823848|NCT01928940|143151367|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
71823849|NCT01928940|143151367|SUPERIORITY_OR_OTHER||Percentage|50.0||||0.0158|TWO_SIDED|95.0|11.8|88.2|||Exact binomial test||BICR Assessed ORR|||88.2|11.8|0.0158
71823850|NCT01928940|143151370|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR|||99.6|35.9|<0.0001
71823851|NCT01928940|143151370|SUPERIORITY_OR_OTHER||Percentage|83.0|||<|0.0001|TWO_SIDED|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR|||99.6|35.9|<0.0001
71823852|NCT01363479|143151390|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.|Risk Difference (RD)|3.21|||||TWO_SIDED|99.0|-2.74|9.17|||||The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.|||9.17|-2.74|
71823853|NCT02408965|143151393|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71823854|NCT02408965|143151394|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71823855|NCT02408965|143151395|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71823856|NCT02408965|143151396|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
71823857|NCT02408965|143151397|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
71823858|NCT02408965|143151398|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71823859|NCT02408965|143151399|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71823860|NCT02408965|143151400|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
71823861|NCT02408965|143151401|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
71823862|NCT01352507|143151402|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilson Score method|||Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).||||<0.001
71823863|NCT01352507|143151404|SUPERIORITY_OR_OTHER||Least Squares (LS) mean difference|0.02||||0.793|TWO_SIDED|95.0|-0.11|0.15||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.15|-0.11|0.793
71823864|NCT01352507|143151405|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.988|TWO_SIDED|95.0|-1.35|1.37||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||1.37|-1.35|0.988
71823865|NCT01352507|143151406|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.102|TWO_SIDED|95.0|-0.01|0.08||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.08|-0.01|0.102
71823866|NCT01352507|143151408|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.861|TWO_SIDED|95.0|-0.22|0.19||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.19|-0.22|0.861
71644606|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|90.0|-0.12|0.44||||||Change at Week 2, Right Finger Taps||0.44|-0.12|
71644607|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.227|||TWO_SIDED|90.0|-0.16|0.6||||||Change at Week 7, Right Finger Taps||0.60|-0.16|
71644608|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.33|0.31||||||Change at Week 7, Right Finger Taps||0.31|-0.33|
71644609|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|90.0|-0.22|0.56||||||Change at Week 12, Right Finger Taps||0.56|-0.22|
71644610|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|90.0|-0.39|0.26||||||Change at Week 12, Right Finger Taps||0.26|-0.39|
71644611|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|90.0|0.12|0.87||||||Change at Week 2, Left Finger Taps||0.87|0.12|
71644612|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.25|0.36||||||Change at Week 2, Left Finger Taps||0.36|-0.25|
71644613|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.218|||TWO_SIDED|90.0|0.22|0.95||||||Change at Week 7, Left Finger Taps||0.95|0.22|
71823867|NCT01352507|143151409|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.495|TWO_SIDED|95.0|-0.19|0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.09|-0.19|0.495
71823868|NCT01352507|143151410|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.917|TWO_SIDED|95.0|-0.18|0.16||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.16|-0.18|0.917
71644614|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.15|0.47||||||Change at Week 7, Left Finger Taps||0.47|-0.15|
71644615|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|0.11|1.02||||||Change at Week 12, Left Finger Taps||1.02|0.11|
71823869|NCT01352507|143151411|SUPERIORITY_OR_OTHER||LS mean difference|1.23||||0.391|TWO_SIDED|95.0|-1.58|4.04||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||4.04|-1.58|0.391
71644616|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.04|0.71||||||Change at Week 12, Left Finger Taps||0.71|-0.04|
71644617|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|90.0|-0.12|0.53||||||Change at Week 2, Right Heel Along Shin Slide||0.53|-0.12|
71644618|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.26|0.27||||||Change at Week 2, Right Heel Along Shin Slide||0.27|-0.26|
71644619|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|90.0|-0.56|0.28||||||Change at Week 7, Right Heel Along Shin Slide||0.28|-0.56|
71644620|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.53|0.19||||||Change at Week 7, Right Heel Along Shin Slide||0.19|-0.53|
71644621|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.12|0.78||||||Change at Week 12,Right Heel Along Shin Slide||0.78|-0.12|
71644622|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.226|||TWO_SIDED|90.0|-0.25|0.51||||||Change at Week 12,Right Heel Along Shin Slide||0.51|-0.25|
71644623|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.51|0.18||||||Change at Week 2, Left Heel Along Shin Slide||0.18|-0.51|
71644624|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.166|||TWO_SIDED|90.0|-0.25|0.31||||||Change at Week 2, Left Heel Along Shin Slide||0.31|-0.25|
71644625|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|90.0|-0.68|0.07||||||Change at Week 7, Left Heel Along Shin Slide||0.07|-0.68|
71644626|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|90.0|-0.48|0.15||||||Change at Week 7, Left Heel Along Shin Slide||0.15|-0.48|
71644627|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|90.0|-0.45|0.4||||||Change at Week 12, Left Heel Along Shin Slide||0.40|-0.45|
71644628|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.34|0.36||||||Change at Week 12, Left Heel Along Shin Slide||0.36|-0.34|
71644629|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.187|||TWO_SIDED|90.0|-0.1|0.53||||||Change at Week 2, Right Heel Along Shin Tap||0.53|-0.10|
71644630|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|0.17|0.69||||||Change at Week 2, Right Heel Along Shin Tap||0.69|0.17|
71644631|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.272|||TWO_SIDED|90.0|-0.72|0.19||||||Change at Week 7, Right Heel Along Shin Tap||0.19|-0.72|
71644632|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|90.0|-0.38|0.39||||||Change at Week 7, Right Heel Along Shin Tap||0.39|-0.38|
71644633|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|90.0|-0.23|0.51||||||Change at Week 12, Right Heel Along Shin Tap||0.51|-0.23|
71644634|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|0.02|0.64||||||Change at Week 12, Right Heel Along Shin Tap||0.64|0.02|
71823870|NCT01352507|143151412|SUPERIORITY_OR_OTHER||LS mean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.18|0.09|<0.001
71644635|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|90.0|-0.17|0.5||||||Change at Week 2, Left Heel Along Shin Tap||0.50|-0.17|
71644636|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|90.0|0.06|0.61||||||Change at Week 2, Left Heel Along Shin Tap||0.61|0.06|
71823871|NCT01352507|143151413|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.19|-0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||-0.09|-0.19|<0.001
71823872|NCT01352507|143151414|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.364|TWO_SIDED|95.0|-0.2|0.55||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis|||||0.55|-0.20|0.364
71823873|NCT00916006|143151442|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71823874|NCT00916006|143151443|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71823875|NCT04824131|143151477|OTHER||Exact CI for Proportions|0.0|||||TWO_SIDED|95.0|0.0|6.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|6.7|0|
71823876|NCT04824131|143151478|OTHER||Exact CI for Proportions|61.5|||||TWO_SIDED|95.0|47.0|74.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|74.7|47.0|
71823877|NCT04824131|143151481|OTHER||Exact CI for Proportions|94.3|||||TWO_SIDED|95.0|84.3|98.8|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase|98.8|84.3|
71823878|NCT04824131|143151482|OTHER||Exact CI for Proportions|100.0|||||TWO_SIDED|95.0|93.3|100.0|||||||Exact 95% Confidence Interval for Proportion for Participants who received at least one Injection who Completed All Scheduled Injections|100|93.3|
71823879|NCT04824131|143151483|OTHER||Mean Difference (Final Values)|-0.2728|STANDARD_ERROR_OF_MEAN|0.1704||0.1093|TWO_SIDED|95.0|-0.61|0.06||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|poisson model||"GEE for Change in Sexual Behavior - Number of Sexual Partners - Visit as Continuous Variable.~Difference from baselines in the number of sex partners (vaginal or anal sex) reported in the past month"|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of sexual partners) using a poisson model.||0.06|-0.61|0.1093
71823880|NCT04824131|143151484|OTHER||Mean Difference (Final Values)|-0.5859|STANDARD_ERROR_OF_MEAN|0.2253||0.0093|TWO_SIDED|95.0|-1.03|-0.14||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month|poisson model||GEE for Change in Sexual Behavior - Number of Episodes of Vaginal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of vaginal sex without a condom reported in the past month.|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model count outcomes (number of episodes of vaginal sex without a condom) using a poisson model.||-0.14|-1.03|0.0093
71823881|NCT04824131|143151484|OTHER||Mean Difference (Final Values)|-0.3087|STANDARD_ERROR_OF_MEAN|1.4036||0.8259|TWO_SIDED|95.0|-3.06|2.44||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Regression, Logistic||GEE for Change in Sexual Behavior - Number of Episodes of Anal Sex without a Condom - Visit as Continuous Variable. Difference from baselines in the number of anal sex without a condom reported in the past month|Generalized estimating equations (GEE) with robust variance to model change in self-reported sexual behavior from enrollment (W0) to follow up visits (W4, W5, W9, W17, W25, W33, W+12, W+24, W+36, W+48), with an indicator variable for all on-study visits (i.e. enrollment visit = 0) to measure change in the outcome behavior. We will model binary outcomes (any episodes of anal sex without a condom) using a logistic model.||2.44|-3.06|0.8259
71823882|NCT04824131|143151485|OTHER||CI for Incidence rate, exact Poisson|0.0|||||TWO_SIDED|95.0|0.0|10.8|||||Person-years: 34.0||Incidence rate is calculated HIV infections per 100 person years. CI for Incidence rate is calculated using exact Poisson method|10.8|0.0|
71823883|NCT05489224|143151486|EQUIVALENCE|Predefined margin: -0.6 to 0.5|Treatment difference and 90% CI|-0.1|||||TWO_SIDED|90.0|-0.3|0.1|||ANCOVA|ANCOVA with multiple imputation||||0.10|-0.30|
71823884|NCT04640571|143151509|EQUIVALENCE|Simple one-way t-test to assess if pravastatin AUC value is larger after metformin than after placebo.||||||0.02|||||||t-test, 1 sided|||||||0.02
71644637|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|90.0|-0.09|0.84||||||Change at Week 7, Left Heel Along Shin Tap||0.84|-0.09|
71644638|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|-0.19|0.6||||||Change at Week 7, Left Heel Along Shin Tap||0.60|-0.19|
71644639|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.303|||TWO_SIDED|90.0|-0.2|0.82||||||Change at Week 12, Left Heel Along Shin Tap||0.82|-0.20|
71644640|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.17|0.67||||||Change at Week 12, Left Heel Along Shin Tap||0.67|-0.17|
71644641|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.5||||||Change at Week 2, Siting Posture||0.5|-0.1|
71644642|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.1|0.4||||||Change at Week 2, Siting Posture||0.4|-0.1|
71644643|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Siting Posture||0.2|-0.4|
71644644|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 7, Siting Posture||0.5|0.0|
71823885|NCT04640571|143151510|EQUIVALENCE|Simple one-way t-test to assess if pravastatin Cmax value is larger after metformin than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823886|NCT04640571|143151511|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71644645|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, Siting Posture||0.2|-0.5|
71644646|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.2|0.3||||||Change at Week 12, Siting Posture||0.3|-0.2|
71644647|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.4|0.4||||||Change at Week 2, SFA - TTA||0.4|-0.4|
71644648|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.3|0.3||||||Change at Week 2, SFA - TTA||0.3|-0.3|
71644649|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA - TTA||0.2|-0.4|
71644650|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 7, SFA - TTA||0.1|-0.5|
71644651|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.3|
71644652|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 12, SFA - TTA||0.4|-0.2|
71644653|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.1|0.3||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.3|-0.1|
71644654|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFA (Eyes Closed) - TTA||0.1|-0.2|
71823887|NCT04640571|143151512|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71644655|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.2|-0.4|
71644656|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.4|0.1||||||Change at Week 7, SFA (Eyes Closed) - TTA||0.1|-0.4|
71644657|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.4|-0.3|
71644658|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.5|0.1||||||Change at Week 12, SFA (Eyes Closed) - TTA||0.1|-0.5|
71644659|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.8|0.2||||||Change at Week 2, SFT - TTA||0.2|-0.8|
71644660|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.0|0.8||||||Change at Week 2, SFT - TTA||0.8|0.0|
71644661|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.3|0.4||||||Change at Week 7, SFT - TTA||0.4|-0.3|
71644662|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.2|0.7||||||Change at Week 7, SFT - TTA||0.7|0.2|
71644663|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.2||||||Change at Week 12, SFT - TTA||0.2|-0.5|
71644664|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.0|0.7||||||Change at Week 12, SFT - TTA||0.7|0.0|
71644665|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
71644666|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) - TTA||0.1|-0.2|
71644667|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.2|
71644668|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, SFT (Eyes Closed) - TTA||0.2|-0.1|
71644669|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.2|0.2||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.2|-0.2|
71644670|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, SFT (Eyes Closed) - TTA||0.0|-0.3|
71644671|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.2|
71644672|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Stance - TTA||0.1|-0.1|
71644673|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.0||||||Change at Week 7, Tandem Stance - TTA||0.0|-0.2|
71644674|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 7, Tandem Stance - TTA||0.2|-0.1|
71644675|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Stance - TTA||0.1|-0.2|
71823888|NCT04640571|143151513|EQUIVALENCE|Simple one-way t-test to assess if acyclovir AUC value is reduced after polysorbate 80 than after placebo|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823889|NCT04640571|143151514|EQUIVALENCE|Simple one-way t-test to assess if acyclovir Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823890|NCT04640571|143151515|EQUIVALENCE|Simple one-way t-test to assess if CDCA AUC value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823891|NCT04640571|143151516|EQUIVALENCE|Simple one-way t-test to assess if CDCA Cmax value is reduced after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823892|NCT04640571|143151517|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat AUC value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823893|NCT04640571|143151518|EQUIVALENCE|Simple one-way t-test to assess if enalaprilat Cmax value is increased after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823894|NCT04640571|143151519|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823895|NCT04640571|143151520|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823896|NCT04640571|143151521|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid AUC value is reduced after metformin than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823897|NCT04640571|143151522|EQUIVALENCE|For each of 15 endogenous bile acid, simple one-way t-test to assess if endogenous bile acid Cmax value is larger after polysorbate 80 than after placebo.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71823898|NCT04863898|143151548|SUPERIORITY||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-7.0|-5.2|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-5.2|-7|
71823899|NCT04863898|143151552|SUPERIORITY||Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||Calculated using a linear mixed effect regression model with random intercepts by individual Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||1.09|0.86|
71823900|NCT04863898|143151553|SUPERIORITY||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-4.7|-3.6|||||LME regression, random intercepts by individual and fixed effects of participant characteristics. Difference = endline - baseline.|Using the PASS software program, we estimated the power for comparisons of scores from pre- to post-intervention, assuming a p-value of 0.05 (two-sided) and a final sample size of 131 with both measurements. We would have 85% power to detect a small-to-medium sized effect based on standardized mean difference (d=0.32).||-3.6|-4.7|
71823901|NCT00770211|143151554|SUPERIORITY_OR_OTHER||Difference response rate|0.48|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.4|0.56|||Fisher Exact|||The efficacy of the treatment was confirmed, if H0 was rejected at a given alpha of 5%, that means if the two sided p-value is ≤ 0.05. Power of 90%||0.56|0.40|<0.0001
71886204|NCT00662792|143292993|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9956|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.03|0.9956
71886205|NCT00662792|143292993|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.71|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7100
71644676|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.2||||||Change at Week 12, Tandem Stance - TTA||0.2|-0.1|
71644677|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
71823902|NCT00764868|143151562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
71823903|NCT00764868|143151564|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks||||||<0.001
71823904|NCT03005288|143151568|SUPERIORITY||Mean Difference (Net)|-7.31|||<|0.001|TWO_SIDED|80.0|-8.48|-6.14|||Mixed-Effect Model Repeated Measure|||||-6.14|-8.48|<0.001
71823905|NCT03005288|143151569|SUPERIORITY||Mean Difference (Net)|-5.19|||<|0.001|TWO_SIDED|80.0|-6.01|-4.37|||Mixed-Effect Model Repeated Measure|||||-4.37|-6.01|<0.001
71823906|NCT03005288|143151570|SUPERIORITY||Mean Difference (Net)|-1.13|||<|0.001|TWO_SIDED|80.0|-1.42|-0.83|||Mixed Models Analysis|||week 24||-0.83|-1.42|<0.001
71823907|NCT03005288|143151570|SUPERIORITY||Mean Difference (Net)|-0.8||||0.005|TWO_SIDED|80.0|-1.2|-0.41|||Mixed Models Analysis|||week 48||-0.41|-1.20|0.005
71823908|NCT03005288|143151574|SUPERIORITY||Mean Difference (Net)|-1.33|||<|0.001|TWO_SIDED|80.0|-1.71|-0.95|||Mixed-Effect Model Repeated Measure|||week 24||-0.95|-1.71|<0.001
71823909|NCT03005288|143151574|SUPERIORITY||Mean Difference (Net)|-1.91|||<|0.001|TWO_SIDED|80.0|-2.48|-1.34|||Mixed-Effect Model Repeated Measure|||week 48||-1.34|-2.48|<0.001
71886206|NCT00662792|143292993|SUPERIORITY||Difference of adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3659|TWO_SIDED|95.0|-0.02|0.04|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.04|-0.02|0.3659
71886207|NCT00662792|143292994|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4416|TWO_SIDED|95.0|-0.04|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.02|-0.04|0.4416
71823910|NCT03005288|143151575|SUPERIORITY||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|80.0|-4.54|-2.31|||Mixed-Effect Model Repeated Measure|||week 24||-2.31|-4.54|<0.001
71644678|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk||0.1|-0.1|
71644679|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.2|
71644680|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.1|0.1||||||Change at Week 7, Tandem Walk||0.1|-0.1|
71644681|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.3|0.0||||||Change at Week 12, Tandem Walk||0.0|-0.3|
71644682|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|90.0|-0.2|0.1||||||Change at Week 12, Tandem Walk||0.1|-0.2|
71644683|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.2|0.4||||||Change at Week 2, Gait||0.4|-0.2|
71644684|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.1|0.7||||||Change at Week 2, Gait||0.7|0.1|
71644685|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 7, Gait||0.2|-0.4|
71644686|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.1|0.6||||||Change at Week 7, Gait||0.6|0.1|
71644687|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.4|0.2||||||Change at Week 12, Gait||0.2|-0.4|
71644688|NCT03214588|142807110|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|0.0|0.5||||||Change at Week 12, Gait||0.5|0.0|
71644689|NCT03214588|142807111|SUPERIORITY||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.889||0.599|TWO_SIDED|90.0|-1.31|1.76||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.76|-1.31|0.599
71644690|NCT03214588|142807111|SUPERIORITY||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.625||0.978|TWO_SIDED|90.0|0.26|2.42||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||2.42|0.26|0.978
71823911|NCT03005288|143151575|SUPERIORITY||Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|80.0|-6.74|-3.47|||Mixed-Effect Model Repeated Measure|||week 48||-3.47|-6.74|<0.001
71644691|NCT03214588|142807111|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.14||0.533|TWO_SIDED|90.0|-1.87|2.06||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||2.06|-1.87|0.533
71644692|NCT03214588|142807111|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.886||0.37|TWO_SIDED|90.0|-1.83|1.23||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||1.23|-1.83|0.370
71644693|NCT03214588|142807111|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.078||0.972|TWO_SIDED|90.0|0.32|4.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||4.04|0.32|0.972
71644694|NCT03214588|142807111|SUPERIORITY||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.819||0.825|TWO_SIDED|90.0|-0.63|2.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||2.19|-0.63|0.825
71644695|NCT03214588|142807112|SUPERIORITY||Least Squares Mean Difference|0.045|STANDARD_ERROR_OF_MEAN|0.23858||0.426|TWO_SIDED|90.0|-0.3665|0.4565||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.4565|-0.3665|0.426
71644696|NCT03214588|142807112|SUPERIORITY||Least Squares Mean Difference|-0.3281|STANDARD_ERROR_OF_MEAN|0.15794||0.975|TWO_SIDED|90.0|-0.6005|-0.0557||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||-0.0557|-0.6005|0.975
71644697|NCT03214588|142807112|SUPERIORITY||Least Squares Mean Difference|0.1448|STANDARD_ERROR_OF_MEAN|0.31186||0.324|TWO_SIDED|90.0|-0.3931|0.6826||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.6826|-0.3931|0.324
71644698|NCT03214588|142807112|SUPERIORITY||Least Squares Mean Difference|0.0113|STANDARD_ERROR_OF_MEAN|0.23213||0.481|TWO_SIDED|90.0|-0.3891|0.4117||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.4117|-0.3891|0.481
71644699|NCT03214588|142807112|SUPERIORITY||Least Squares Mean Difference|-0.2067|STANDARD_ERROR_OF_MEAN|0.28088||0.765|TWO_SIDED|90.0|-0.6911|0.2778||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.2778|-0.6911|0.765
71644700|NCT03214588|142807112|SUPERIORITY||Least Squares Mean Difference|0.1173|STANDARD_ERROR_OF_MEAN|0.19778||0.28|TWO_SIDED|90.0|-0.2238|0.4585||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.4585|-0.2238|0.280
71644701|NCT03214588|142807113|SUPERIORITY||Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.28||0.735|TWO_SIDED|90.0|-9.9|4.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||4.4|-9.9|0.735
71823912|NCT03005288|143151576|SUPERIORITY||Mean Difference (Net)|1.49||||0.003|TWO_SIDED|80.0|0.82|2.06|||Mixed-Effect Model Repeated Measure|||week 24||2.06|0.82|0.003
71823913|NCT03005288|143151576|SUPERIORITY||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|80.0|1.36|2.93|||Mixed-Effect Model Repeated Measure|||week 48||2.93|1.36|<0.001
71823914|NCT03005288|143151577|SUPERIORITY||Mean Difference (Net)|-4.09|||<|0.001|TWO_SIDED|80.0|-5.26|-2.92|||Mixed-Effect Model Repeated Measure|||week 24||-2.92|-5.26|<0.001
71823915|NCT03005288|143151577|SUPERIORITY||Mean Difference (Net)|-9.46|||<|0.001|TWO_SIDED|80.0|-11.3|-7.64|||Mixed-Effect Model Repeated Measure|||week 52||-7.64|-11.3|<0.001
71644702|NCT03214588|142807113|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.51||0.182|TWO_SIDED|90.0|-2.7|9.1||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||9.1|-2.7|0.182
71644703|NCT03214588|142807113|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.59||0.97|TWO_SIDED|90.0|-12.9|-0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||-0.9|-12.9|0.970
71644704|NCT03214588|142807113|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|3.0||0.321|TWO_SIDED|90.0|-3.6|6.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||6.4|-3.6|0.321
71644705|NCT03214588|142807113|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.34||0.905|TWO_SIDED|90.0|-13.0|1.5||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||1.5|-13.0|0.905
71644706|NCT03214588|142807113|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.57||0.199|TWO_SIDED|90.0|-2.9|9.0||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||9.0|-2.9|0.199
71644707|NCT03214588|142807114|SUPERIORITY|||||||0.974||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.974
71644708|NCT03214588|142807114|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.893
71644709|NCT03214588|142807114|SUPERIORITY|||||||0.954||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.954
71644710|NCT03214588|142807114|SUPERIORITY|||||||0.793||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.793
71644711|NCT03214588|142807114|SUPERIORITY|||||||0.845||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.845
71644712|NCT03214588|142807114|SUPERIORITY|||||||0.816||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.816
71644713|NCT03214588|142807115|SUPERIORITY|||||||0.84||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.840
71644714|NCT03214588|142807115|SUPERIORITY|||||||0.854||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.854
71823916|NCT03005288|143151578|SUPERIORITY||Mean Difference (Net)|-0.02||||0.062|TWO_SIDED|80.0|-0.03|0.0|||Mixed-Effect Model Repeated Measure|||week 24||-0.00|-0.03|0.062
71644715|NCT03214588|142807115|SUPERIORITY|||||||0.922||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.922
71823917|NCT03005288|143151578|SUPERIORITY||Mean Difference (Net)|-0.06|||<|0.001|TWO_SIDED|80.0|-0.08|-0.04|||Mixed-Effect Model Repeated Measure|||week 52||-0.04|-0.08|<0.001
71644716|NCT03214588|142807115|SUPERIORITY|||||||0.794||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.794
71644717|NCT03214588|142807115|SUPERIORITY|||||||0.83||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.830
71644718|NCT03214588|142807115|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
71644719|NCT03214588|142807116|SUPERIORITY|||||||0.987||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.987
71644720|NCT03214588|142807116|SUPERIORITY|||||||0.771||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.771
71644721|NCT03214588|142807116|SUPERIORITY|||||||0.526||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.526
71644722|NCT03214588|142807116|SUPERIORITY|||||||0.665||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.665
71644723|NCT03214588|142807116|SUPERIORITY|||||||0.576||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.576
71644724|NCT03214588|142807116|SUPERIORITY|||||||0.865||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.865
71644725|NCT03214588|142807117|SUPERIORITY|||||||0.966||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.966
71644726|NCT03214588|142807117|SUPERIORITY|||||||0.983||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.983
71823918|NCT03005288|143151579|SUPERIORITY||Mean Difference (Net)|-0.65||||0.028|TWO_SIDED|80.0|-1.03|-0.28|||Mixed-Effect Model Repeated Measure|||week 12||-0.28|-1.03|0.028
71823919|NCT03005288|143151579|SUPERIORITY||Mean Difference (Net)|-0.66||||0.081|TWO_SIDED|80.0|-1.14|-0.18|||Mixed-Effect Model Repeated Measure|||week 36||-0.18|-1.14|0.081
71886208|NCT00662792|143292994|SUPERIORITY||Difference of adjusted means|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.7058|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.02|-0.03|0.7058
71644727|NCT03214588|142807117|SUPERIORITY|||||||0.953||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.953
71644728|NCT03214588|142807117|SUPERIORITY|||||||0.781||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.781
71644729|NCT03214588|142807117|SUPERIORITY|||||||0.948||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.948
71644730|NCT03214588|142807117|SUPERIORITY|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.998
71644731|NCT03214588|142807118|SUPERIORITY|||||||0.666||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.666
71644732|NCT03214588|142807118|SUPERIORITY|||||||0.812||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.812
71644733|NCT03214588|142807118|SUPERIORITY|||||||0.834||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.834
71644734|NCT03214588|142807118|SUPERIORITY|||||||0.841||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.841
71644735|NCT03214588|142807118|SUPERIORITY|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.893
71644736|NCT03214588|142807118|SUPERIORITY|||||||0.907||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.907
71644737|NCT03214588|142807119|SUPERIORITY|||||||0.032||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.032
71644738|NCT03214588|142807119|SUPERIORITY|||||||0.216||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.216
71644739|NCT03214588|142807119|SUPERIORITY|||||||0.215||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.215
71644740|NCT03214588|142807119|SUPERIORITY|||||||0.411||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.411
71644741|NCT03214588|142807119|SUPERIORITY|||||||0.194||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.194
71644742|NCT03214588|142807119|SUPERIORITY|||||||0.408||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.408
71644743|NCT03214588|142807120|SUPERIORITY|||||||0.406||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.406
71644744|NCT03214588|142807120|SUPERIORITY|||||||0.235||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.235
71644745|NCT03214588|142807120|SUPERIORITY|||||||0.225||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.225
71644746|NCT03214588|142807120|SUPERIORITY|||||||0.434||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.434
71644747|NCT03214588|142807120|SUPERIORITY|||||||0.249||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.249
71644748|NCT03214588|142807120|SUPERIORITY|||||||0.38||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.380
71644749|NCT03214588|142807121|SUPERIORITY|||||||0.422||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.422
71644750|NCT03214588|142807121|SUPERIORITY|||||||0.226||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2||||0.226
71644751|NCT03214588|142807121|SUPERIORITY|||||||0.639||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.639
71644752|NCT03214588|142807121|SUPERIORITY|||||||0.094||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7||||0.094
71644753|NCT03214588|142807121|SUPERIORITY|||||||0.516||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.516
71644754|NCT03214588|142807121|SUPERIORITY|||||||0.266||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12||||0.266
71644755|NCT03214588|142807122|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.362||0.299|TWO_SIDED|90.0|-0.8|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||0.41|-0.80|0.299
71644756|NCT03214588|142807122|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.293||0.967|TWO_SIDED|90.0|0.06|1.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2||1.04|0.06|0.967
71644757|NCT03214588|142807122|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.338||0.529|TWO_SIDED|90.0|-0.54|0.59||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.59|-0.54|0.529
71644758|NCT03214588|142807122|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.279||0.88|TWO_SIDED|90.0|-0.13|0.8||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7||0.80|-0.13|0.880
71644759|NCT03214588|142807122|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.408||0.599|TWO_SIDED|90.0|-0.58|0.79||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.79|-0.58|0.599
71644760|NCT03214588|142807122|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.333||0.846|TWO_SIDED|90.0|-0.21|0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12||0.90|-0.21|0.846
71644761|NCT03214588|142807123|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
71644762|NCT03214588|142807123|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline||||>0.999
71644763|NCT03214588|142807123|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
71823920|NCT03253653|143151590|OTHER||z score|1.578||||0.115|TWO_SIDED||||||Wilcoxon signed-rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.115
71886209|NCT00662792|143292994|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.1494|TWO_SIDED|95.0|-0.01|0.05|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.05|-0.01|0.1494
71644764|NCT03214588|142807123|SUPERIORITY||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline||||>0.999
71644765|NCT03480763|142807124|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.2||||0.043|TWO_SIDED|95.0|0.1|8.5|||Miettinen & Nurminen|||Injection site redness/erythema||8.5|0.1|0.043
71644766|NCT03480763|142807124|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|13.7|||<|0.001|TWO_SIDED|95.0|6.0|21.2|||Miettinen & Nurminen|||Injection site tenderness/pain||21.2|6.0|<0.001
71644767|NCT03480763|142807124|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.8||||0.077|TWO_SIDED|95.0|-0.5|10.2|||Miettinen & Nurminen|||Injection site swelling||10.2|-0.5|0.077
71644768|NCT03480763|142807125|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.6||||0.855|TWO_SIDED|95.0|-5.5|6.6|||Miettinen & Nurminen|||Injection site redness/erythema||6.6|-5.5|0.855
71644769|NCT03480763|142807125|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.5||||0.385||95.0|-4.4|11.3|||Miettinen & Nurminen|||Injection site tenderness/pain||11.3|-4.4|0.385
71644770|NCT03480763|142807125|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|2.0||||0.577|TWO_SIDED|95.0|-5.1|9.2|||Miettinen & Nurminen|||Injection site swelling||9.2|-5.1|0.577
71644771|NCT03480763|142807126|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.2||||0.523|TWO_SIDED|95.0|-2.5|4.9|||Miettinen & Nurminen|||Joint pain/arthralgia||4.9|-2.5|0.523
71644772|NCT03480763|142807126|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|9.7||||0.002|TWO_SIDED|95.0|3.7|15.6|||Miettinen & Nurminen|||Tiredness/fatigue||15.6|3.7|0.002
71644773|NCT03480763|142807126|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.4||||0.597|TWO_SIDED|95.0|-3.9|6.7|||Miettinen & Nurminen|||Headache||6.7|-3.9|0.597
71644774|NCT03480763|142807126|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|6.6||||0.016|TWO_SIDED|95.0|1.2|12.1|||Miettinen & Nurminen|||Muscle pain/myalgia||12.1|1.2|0.016
71644775|NCT03480763|142807127|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.961|TWO_SIDED|95.0|-4.4|4.7|||Miettinen & Nurminen|||Joint pain/arthralgia||4.7|-4.4|0.961
71644776|NCT03480763|142807127|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.0||||0.252|TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||Tiredness/fatigue||10.8|-2.8|0.252
71644777|NCT03480763|142807127|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.5||||0.852|TWO_SIDED|95.0|-5.8|4.8|||Miettinen & Nurminen|||Headache||4.8|-5.8|0.852
71644778|NCT03480763|142807127|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|4.9||||0.125|TWO_SIDED|95.0|-1.4|11.2|||Miettinen & Nurminen|||Muscle pain/myalgia||11.2|-1.4|0.125
71644779|NCT03480763|142807128|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||Vaccine-related SAEs following V114 or Prevnar 13™||1.2|-1.2|
71644780|NCT03480763|142807129|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||Vaccine-related SAEs following PNEUMOVAX™23||1.3|-1.3|
71644781|NCT03480763|142807130|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.38|||||TWO_SIDED|95.0|1.1|1.74||||||Serotype 1 (Shared)||1.74|1.10|
71644782|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.9|1.29||||||Serotype 3 (Shared)||1.29|0.90|
71644783|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 4 (Shared)||1.32|0.85|
71644784|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.94|1.56||||||Serotype 5 (Shared)||1.56|0.94|
71644785|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43||||||Serotype 6A (Shared)||1.43|0.95|
71644786|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||Serotype 6B (Shared)||1.35|0.93|
71644787|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||Serotype 7F (Shared)||1.25|0.90|
71644788|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||Serotype 9V (Shared)||1.33|0.91|
71644789|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.27|||||TWO_SIDED|95.0|1.05|1.53||||||Serotype 14 (Shared)||1.53|1.05|
71644790|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||Serotype 18C (Shared)||1.34|0.95|
71823921|NCT03253653|143151591|OTHER||z|0.497||||0.619|TWO_SIDED||||||z||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.619
71644791|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.96|1.38||||||Serotype 19A (Shared)||1.38|0.96|
71644792|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2||||||Serotype 19F (Shared)||1.20|0.89|
71644793|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.01|1.61||||||Serotype 23F (Shared)||1.61|1.01|
71644794|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.63|||||TWO_SIDED|95.0|1.29|2.06||||||Serotype 22F (Unique to V114)||2.06|1.29|
71644795|NCT03480763|142807130|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Serotype 33F (Unique to V114)||1.17|0.77|
71644796|NCT03480763|142807131|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 1 (Shared)||1.07|0.79|
71644797|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3 (Shared)||1.16|0.87|
71644798|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Serotype 4 (Shared)||1.02|0.74|
71886210|NCT00662792|143292995|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.998|TWO_SIDED|95.0|-0.06|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.06|-0.06|0.9980
71644799|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.18||||||Serotype 5 (Shared)||1.18|0.84|
71644800|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 6A (Shared)||1.41|0.96|
71644801|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.4||||||Serotype 6B (Shared)||1.40|0.96|
71644802|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 7F (Shared)||1.16|0.85|
71644803|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.22||||||Serotype 9V (Shared)||1.22|0.89|
71644804|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|0.98|1.39||||||Serotype 14 (Shared)||1.39|0.98|
71644805|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.36||||||Serotype 18C (Shared)||1.36|1.00|
71644806|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.29||||||Serotype 19A (Shared)||1.29|0.95|
71644807|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.93|1.27||||||Serotype 19F (Shared)||1.27|0.93|
71644808|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.96|1.35||||||Serotype 23F (Shared)||1.35|0.96|
71644809|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 22F (Unique to V114)||1.77|1.16|
71644810|NCT03480763|142807131|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||Serotype 33F (Unique to V114)||0.95|0.67|
71644811|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.94|1.58||||||Serotype 1 (Shared)||1.58|0.94|
71644812|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.3||||||Serotype 3 (Shared)||2.30|1.56|
71644813|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4 (Shared)||0.97|0.60|
71644814|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.07|||||TWO_SIDED|95.0|0.81|1.4||||||Serotype 5 (Shared)||1.40|0.81|
71644815|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 6A (Shared)||1.53|0.92|
71644816|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.64|||||TWO_SIDED|95.0|1.31|2.06||||||Serotype 6B (Shared)||2.06|1.31|
71886211|NCT00662792|143292995|SUPERIORITY||Difference of adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4618|TWO_SIDED|95.0|-0.04|0.08|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.08|-0.04|0.4618
71644817|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.14||||||Serotype 7F (Shared)||1.14|0.80|
71644818|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.24||||||Serotype 9V (Shared)||1.24|0.83|
71644819|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.37||||||Serotype 14 (Shared)||1.37|0.87|
71644820|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.84||||||Serotype 18C (Shared)||1.84|1.20|
71644821|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.06|1.55||||||Serotype 19A (Shared)||1.55|1.06|
71644822|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.32||||||Serotype 19F (Shared)||1.32|0.92|
71644823|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.53|||||TWO_SIDED|95.0|1.18|2.0||||||Serotype 23F (Shared)||2.00|1.18|
71644824|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|34.86|||||TWO_SIDED|95.0|26.13|46.5||||||Serotype 22F (Unique to V114)||46.50|26.13|
71644825|NCT03480763|142807132|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|9.15|||||TWO_SIDED|95.0|7.48|11.2||||||Serotype 33F (Unique to V114)||11.20|7.48|
71644826|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.72|1.09||||||Serotype 1 (Shared)||1.09|0.72|
71644827|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.74|||||TWO_SIDED|95.0|1.46|2.07||||||Serotype 3 (Shared)||2.07|1.46|
71644828|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.99||||||Serotype 4 (Shared)||0.99|0.64|
71644829|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.3||||||Serotype 5 (Shared)||1.30|0.84|
71644830|NCT03480763|142807133|OTHER|GMCs, GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.77||||||Serotype 6A (Shared)||1.77|1.10|
71644831|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|1.28|2.1||||||Serotype 6B (Shared)||2.10|1.28|
71644832|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.74|1.13||||||Serotype 7F (Shared)||1.13|0.74|
71644833|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.41||||||Serotype 9V (Shared)||1.41|0.91|
71644834|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 14 (Shared)||1.38|0.87|
71644835|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.56|||||TWO_SIDED|95.0|1.27|1.92||||||Serotype 18C (Shared)||1.92|1.27|
71644836|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.91|1.39||||||Serotype 19A (Shared)||1.39|0.91|
71644837|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|0.92|1.41||||||Serotype 19F (Shared)||1.41|0.92|
71644838|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.61|||||TWO_SIDED|95.0|1.27|2.04||||||Serotype 23F (Shared)||2.04|1.27|
71644839|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|16.54|||||TWO_SIDED|95.0|13.78|19.86||||||Serotype 22F (Unique to V114)||19.86|13.78|
71644840|NCT03480763|142807133|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|12.82|||||TWO_SIDED|95.0|10.82|15.19||||||Serotype 33F (Unique to V114)||15.19|10.82|
71644841|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.92|1.53||||||Serotype 1 (Shared)||1.53|0.92|
71644842|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.29|1.9||||||Serotype 3 (Shared)||1.90|1.29|
71644843|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 4 (Shared)||0.90|0.57|
71644844|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.78|1.33||||||Serotype 5 (Shared)||1.33|0.78|
71644845|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.93|1.41||||||Serotype 6A (Shared)||1.41|0.93|
71644846|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.43|||||TWO_SIDED|95.0|1.16|1.77||||||Serotype 6B (Shared)||1.77|1.16|
71644847|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.11||||||Serotype 7F (Shared)||1.11|0.80|
71644848|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.81|1.18||||||Serotype 9V (Shared)||1.18|0.81|
71644849|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.9|1.36||||||Serotype 14 (Shared)||1.36|0.90|
71644850|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.05|1.55||||||Serotype 18C (Shared)||1.55|1.05|
71644851|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.31||||||Serotype 19A (Shared)||1.31|0.91|
71644852|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.08|||||TWO_SIDED|95.0|0.91|1.29||||||Serotype 19F (Shared)||1.29|0.91|
71644853|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|1.37|||||TWO_SIDED|95.0|1.06|1.76||||||Serotype 23F (Shared)||1.76|1.06|
71644854|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.79|||||TWO_SIDED|95.0|9.44|17.34||||||Serotype 22F (Unique to V114)||17.34|9.44|
71644855|NCT03480763|142807138|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.24|||||TWO_SIDED|95.0|2.73|3.84||||||Serotype 33F (Unique to V114)||3.84|2.73|
71644856|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.65|0.92||||||Serotype 1 (Shared)||0.92|0.65|
71644857|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.24|1.63||||||Serotype 3 (Shared)||1.63|1.24|
71644858|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 4 (Shared)||0.91|0.64|
71644859|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.75|1.05||||||Serotype 5 (Shared)||1.05|0.75|
71644860|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.37|||||TWO_SIDED|95.0|1.12|1.67||||||Serotype 6A (Shared)||1.67|1.12|
71644861|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.81||||||Serotype 6B (Shared)||1.81|1.21|
71644862|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Serotype 7F (Shared)||1.02|0.72|
71644863|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.23||||||Serotype 9V (Shared)||1.23|0.88|
71644864|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||Serotype 14 (Shared)||1.26|0.88|
71644865|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 18C (Shared)||1.64|1.17|
71644866|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.33||||||Serotype 19A (Shared)||1.33|0.97|
71644867|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.13|||||TWO_SIDED|95.0|0.96|1.32||||||Serotype 19F (Shared)||1.32|0.96|
71644868|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.35|||||TWO_SIDED|95.0|1.12|1.62||||||Serotype 23F (Shared)||1.62|1.12|
71644869|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|6.2|||||TWO_SIDED|95.0|5.33|7.21||||||Serotype 22F (Unique to V114)||7.21|5.33|
71644870|NCT03480763|142807139|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|5.01|||||TWO_SIDED|95.0|4.38|5.73||||||Serotype 33F (Unique to V114)||5.73|4.38|
71644871|NCT05143801|142807174|EQUIVALENCE|Main effect for environmental conditions.||||||0.003||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.003
71644872|NCT05143801|142807174|EQUIVALENCE|Main effect for mask condition.||||||0.933||||||Statistical significance was set at p \< 0.05.|2x2 repeated measures ANOVA|||||||0.933
71644873|NCT05143801|142807174|EQUIVALENCE|Interaction effect across environmental and mask conditions.|No Method of Estimation was used|||||0.344||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 repeated measures ANOVA|||||||0.344
71644874|NCT05143801|142807175|EQUIVALENCE|Main effect for environmental conditions.||||||0.117||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||A 2x2 repeated measures ANOVA was performed to investigate statistical differences for all variables across the four conditions. Both main and interaction effects were calculated along with effect size, reported as partial ⴄ2 as provided by the statistical software JASP (version 0.14.1.0).||||0.117
71644875|NCT05143801|142807175|EQUIVALENCE|Main effect for mask condition||||||0.832||||||Statistical significance was set at p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.832
71644876|NCT05143801|142807175|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.879||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.879
71644877|NCT05143801|142807176|EQUIVALENCE|Main effect for environmental condition.||||||0.749||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.749
71644878|NCT05143801|142807176|EQUIVALENCE|Main effect for mask condition.||||||0.311||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.311
71644879|NCT05143801|142807176|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.368||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.368
71644880|NCT05143801|142807177|EQUIVALENCE|Main effect for environmental condition.||||||0.789||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.789
71644881|NCT05143801|142807177|EQUIVALENCE|Main effect for mask condition.||||||0.739||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.739
71644882|NCT05143801|142807177|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.158||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.158
71644883|NCT05143801|142807178|EQUIVALENCE|Main effect for environmental condition.||||||0.394||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.394
71644884|NCT05143801|142807178|EQUIVALENCE|Main effect for mask condition||||||0.157||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.157
71644885|NCT05143801|142807178|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.015||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.015
71644886|NCT05143801|142807179|EQUIVALENCE|Main effect for environmental condition.||||||0.96||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.960
71644887|NCT05143801|142807179|EQUIVALENCE|Main effect for mask condition.||||||0.073||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.073
71644888|NCT05143801|142807179|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.503||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.503
71644889|NCT05143801|142807180|EQUIVALENCE|Main effect for environmental condition.||||||0.786||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.786
71644890|NCT05143801|142807180|EQUIVALENCE|Main effect for mask condition.||||||0.18||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.180
71644891|NCT05143801|142807180|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.239||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.239
71644892|NCT05143801|142807181|EQUIVALENCE|Main effect for environmental condition.||||||0.134||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.134
71644893|NCT05143801|142807181|EQUIVALENCE|Main effect for mask condition.||||||0.621||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.621
71644894|NCT05143801|142807181|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.553||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.553
71644895|NCT05143801|142807182|EQUIVALENCE|Main effect for environmental condition.||||||0.461||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.461
71644896|NCT05143801|142807182|EQUIVALENCE|Main effect for mask condition.||||||0.877||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.877
71644897|NCT05143801|142807182|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.919||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.919
71644898|NCT05143801|142807183|EQUIVALENCE|Main effect for environmental condition.||||||0.466||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.466
71644899|NCT05143801|142807183|EQUIVALENCE|Main effect for mask condition.||||||0.186||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.186
71644900|NCT05143801|142807183|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.08||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.080
71644901|NCT05143801|142807184|EQUIVALENCE|Main effect for environmental condition.||||||0.375||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.375
71644902|NCT05143801|142807184|EQUIVALENCE|Main effect for mask condition.||||||0.178||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.178
71644903|NCT05143801|142807184|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.533||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.533
71644904|NCT05143801|142807185|EQUIVALENCE|Main effect for environmental condition.||||||0.29||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.290
71644905|NCT05143801|142807185|EQUIVALENCE|Main effect for mask condition.||||||0.527||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.527
71644906|NCT05143801|142807185|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.045||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.045
71644907|NCT05143801|142807186|EQUIVALENCE|Main effect for environmental condition.||||||0.018||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||0.018
71644908|NCT05143801|142807186|EQUIVALENCE|Main effect for mask condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2x3 Repeated Measures ANOVA|||||||<0.001
71644909|NCT05143801|142807186|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.035||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2x3 Repeated Measures ANOVA|||||||0.035
71644910|NCT05143801|142807187|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
71644911|NCT05143801|142807187|EQUIVALENCE|Main effect for mask condition.||||||0.678||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.678
71644912|NCT05143801|142807187|EQUIVALENCE|Interaction effect||||||0.678|||||||2x2 Repeated Measures ANOVA|||||||0.678
71644913|NCT05143801|142807188|EQUIVALENCE|Main effect for environmental condition.|||||<|0.001||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||<0.001
71644914|NCT05143801|142807188|EQUIVALENCE|Main effect for mask condition.||||||0.487||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.487
71644915|NCT05143801|142807188|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.79||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.790
71644916|NCT05143801|142807189|EQUIVALENCE|Main effect for environmental condition.||||||0.089||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.089
71644917|NCT05143801|142807189|EQUIVALENCE|Main effect for mask condition.||||||0.297||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.297
71644918|NCT05143801|142807189|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.111||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.111
71644919|NCT05143801|142807190|EQUIVALENCE|Main effect for environmental condition.||||||0.024||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.024
71644920|NCT05143801|142807190|EQUIVALENCE|Main effect for mask condition.||||||0.002||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.002
71644921|NCT05143801|142807190|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.014||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.014
71644922|NCT05143801|142807191|EQUIVALENCE|Main effect for environmental condition.||||||0.012||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.012
71823922|NCT03253653|143151592|OTHER||z|1.72||||0.085|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.085
71644923|NCT05143801|142807191|EQUIVALENCE|Main effect for mask condition.||||||0.893||||||Statistical significance was set at p \< 0.05|2x2 Repeated Measures ANOVA|||||||0.893
71823923|NCT03253653|143151593|OTHER||z|6.154|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in biomarker levels for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||<0.001
71886212|NCT00662792|143292995|SUPERIORITY||Difference of adjusted means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0418|TWO_SIDED|95.0|0.0|0.12|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.12|0.00|0.0418
71644924|NCT05143801|142807191|EQUIVALENCE|Interaction effect across environmental and mask conditions.||||||0.969||||||A Bonferroni post-hoc test was used if significant interaction effect was present and p-values were adjusted based on the number of comparisons. To determine if a post-hoc was needed statistical significance was set to p \< 0.05.|2x2 Repeated Measures ANOVA|||||||0.969
71644925|NCT03629054|142807192|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R).|Adjusted gMean ratio|100.42|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|90.0|98.17|102.72|||ANOVA||gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV).|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||102.72|98.17|<0.0001
71644926|NCT03629054|142807193|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.34|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|91.58|99.24|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.24|91.58|<0.0001
71644927|NCT03629054|142807194|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.16|STANDARD_ERROR_OF_MEAN|8.6|<|0.0001|TWO_SIDED|90.0|96.17|104.31|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||104.31|96.17|<0.0001
71644928|NCT03629054|142807195|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|92.57|STANDARD_ERROR_OF_MEAN|17.9||0.0029|TWO_SIDED|90.0|85.21|100.57|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||100.57|85.21|0.0029
71644929|NCT03629054|142807196|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|97.33|STANDARD_ERROR_OF_MEAN|16.9||0.0001|TWO_SIDED|90.0|89.99|105.26|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||105.26|89.99|0.0001
71644930|NCT03629054|142807197|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|104.83|STANDARD_ERROR_OF_MEAN|13.2|<|0.0001|TWO_SIDED|90.0|98.56|111.5|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||111.50|98.56|<0.0001
71660941|NCT03118570|142835402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.283||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.283
71644931|NCT03629054|142807198|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.73|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|90.0|98.33|103.18|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||103.18|98.33|<0.0001
71644932|NCT03629054|142807199|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|103.57|STANDARD_ERROR_OF_MEAN|14.3|<|0.0001|TWO_SIDED|90.0|96.9|110.71|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||110.71|96.90|<0.0001
71644933|NCT03629054|142807200|EQUIVALENCE|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.74|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|90.0|92.29|99.32|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for 'sequence', 'period' and 'treatment' and random effect for 'subject within sequence'.||99.32|92.29|<0.0001
71644934|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.22|TWO_SIDED|95.0|0.322|1.302|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).||1.302|0.322|0.22
71644935|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.647||||0.24|TWO_SIDED|95.0|0.322|1.301|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.301|0.322|0.24
71644936|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.83|TWO_SIDED|95.0|0.501|2.405|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.501|0.83
71644937|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074||||0.87|TWO_SIDED|95.0|0.49|2.356|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.356|0.490|0.87
71644938|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.96|TWO_SIDED|95.0|0.458|2.131|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.131|0.458|0.96
71644939|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.16|TWO_SIDED|95.0|0.289|1.212|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.212|0.289|0.16
71644940|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.035|TWO_SIDED|95.0|0.324|0.937|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.937|0.324|0.035
71644941|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.624||||0.07|TWO_SIDED|95.0|0.373|1.045|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.045|0.373|0.070
71644942|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.085||||0.79|TWO_SIDED|95.0|0.605|1.947|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg \[Core\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.947|0.605|0.79
71823924|NCT03253653|143151594|OTHER||z|-1.144||||0.253|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in systolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in biomarker levels for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.253
71644943|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.959||||0.99|TWO_SIDED|95.0|0.527|1.743|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Raloxifene 60 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.743|0.527|0.99
71644944|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.78|TWO_SIDED|95.0|0.488|1.593|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40 mg \[Core\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.593|0.488|0.78
71644945|NCT00205777|142807202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.036|TWO_SIDED|95.0|0.34|0.968|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg \[Core\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.968|0.340|0.036
71644946|NCT00205777|142807203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.097|TWO_SIDED|95.0|0.339|1.099|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.099|0.339|0.097
71886213|NCT00662792|143292996|SUPERIORITY||Difference of adjusted means|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4206|TWO_SIDED|95.0|-0.08|0.03|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Tio18GEL)|||0.03|-0.08|0.4206
71644947|NCT00205777|142807203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.645||||0.15|TWO_SIDED|95.0|0.361|1.151|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.151|0.361|0.15
71644948|NCT00205777|142807203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.83|TWO_SIDED|95.0|0.493|1.793|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.793|0.493|0.83
71644949|NCT00205777|142807203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.067|TWO_SIDED|95.0|0.435|1.019|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.019|0.435|0.067
71644950|NCT00205777|142807203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.014|TWO_SIDED|95.0|0.367|0.896|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.896|0.367|0.014
71823925|NCT03253653|143151595|OTHER||z|-1.004||||0.315|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in diastolic blood pressure for the Charcoal-heated tobacco smoking session (n=50) significantly different from the pre-to-post change in diastolic blood pressure for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.315
71823926|NCT03253653|143151596|OTHER||z|3.089||||0.002|TWO_SIDED||||||Wilcox and signed rank test||||We used the Wilcoxon signed-rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects tests, to determine whether the pre-to-post change in heart rate for the Charcoal-heated tobacco smoking session (n=50) was significantly different from the pre-to-post change in heart rate for the Electric Head-heated tobacco smoking session (using the same 50 participants after a weeklong washout period).|||0.002
71823927|NCT03253653|143151597|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
71886214|NCT00662792|143292996|SUPERIORITY||Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.8723|TWO_SIDED|95.0|-0.05|0.06|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (Salm50DPI)|||0.06|-0.05|0.8723
71886215|NCT00662792|143292996|SUPERIORITY||Difference of adjusted means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1005|TWO_SIDED|95.0|-0.01|0.11|||ANOVA|Analysis of variance with terms for centre, patient within centre, treatment, and period. α = 0.05 two-sided.|(T+S\_PE) - (T18GEL+S-DPI)|||0.11|-0.01|0.1005
71886216|NCT00441545|143293012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0|||||ANCOVA|||||||0.1130
71886217|NCT00441545|143293013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0249||95.0|||||ANCOVA|||||||0.0249
71886218|NCT02347176|143293016|SUPERIORITY||Adjusted Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.968||0.143|TWO_SIDED|95.0|-6.78|0.99|||Mixed Model Repeated Measures Analysis|||||0.99|-6.78|0.143
71886219|NCT02347176|143293016|SUPERIORITY||Adjusted Mean Difference|-4.36|STANDARD_ERROR_OF_MEAN|1.951||0.027|TWO_SIDED|95.0|-8.22|-0.51|||Mixed Model Repeated Measures Analysis|||||-0.51|-8.22|0.027
71886220|NCT02347176|143293016|SUPERIORITY||Adjusted Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.932||0.011|TWO_SIDED|95.0|-8.76|-1.13|||Mixed Model Repeated Measures Analysis|||||-1.13|-8.76|0.011
71886221|NCT02347176|143293017|SUPERIORITY||Odds Ratio (OR)|0.98||||0.974|TWO_SIDED|95.0|0.29|3.32|||Regression, Logistic|||||3.32|0.29|0.974
71886222|NCT02347176|143293017|SUPERIORITY||Odds Ratio (OR)|1.85||||0.281|TWO_SIDED|95.0|0.61|5.65|||Regression, Logistic|||||5.65|0.61|0.281
71660942|NCT03118570|142835402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.354||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.354
71886223|NCT02347176|143293017|SUPERIORITY||Odds Ratio (OR)|2.83||||0.061|TWO_SIDED|95.0|0.95|8.37|||Regression, Logistic|||||8.37|0.95|0.061
71886224|NCT03285243|143293113|OTHER|||||||0.001||||||A priori, All p-values \< 0.05 were considered statistically significant.|Chi-squared|||||||0.001
71886225|NCT03285243|143293114|OTHER|||||||0.002||||||a priori, all p-values \< 0.05 were considered statistically significant.|Regression, Logistic|||||||0.002
71886226|NCT03403205|143293115|OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|1.14|2.13||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||2.13|1.14|< 0.0001
71886227|NCT03403205|143293115|OTHER||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|0.584|<|0.0001|TWO_SIDED|95.0|2.65|4.94||Test was performed at a significance level of 0.05.|ANCOVA|||Analysis was performed using ANCOVA model, which included treatment, cohort, and baseline value. Missing imputation was performed: 1) for intermediate missing, interpolation was used to fill out missing values. 2) For participants who die, baseline dNCC was carried forward from discontinuation to week 48. 3) For others, multiple imputation was used to impute missing dNCC assuming data were missing not at random.||4.94|2.65|< 0.0001
71886228|NCT01834729|143293127|SUPERIORITY|||||||0.78|||||||Least squares means|||||||0.78
71886229|NCT01834729|143293128|SUPERIORITY|||||||0.57|||||||Least squares means|||||||0.57
71644951|NCT00205777|142807203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.5|TWO_SIDED|95.0|0.71|1.885|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.885|0.710|0.50
71644952|NCT00205777|142807204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.085|TWO_SIDED|95.0|0.44|1.052|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.052|0.440|0.085
71644953|NCT00205777|142807204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.004|TWO_SIDED|95.0|0.434|0.857|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||0.857|0.434|0.004
71644954|NCT00205777|142807205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.621||||0.4|TWO_SIDED|95.0|0.203|1.903|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.903|0.203|0.40
71644955|NCT00205777|142807205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.504||||0.26|TWO_SIDED|95.0|0.151|1.676|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.676|0.151|0.26
71644956|NCT00205777|142807205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.33|TWO_SIDED|95.0|0.157|1.86|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||1.860|0.157|0.33
71644957|NCT00205777|142807205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.661||||0.49|TWO_SIDED|95.0|0.206|2.118|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.118|0.206|0.49
71644958|NCT00205777|142807205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.76|TWO_SIDED|95.0|0.305|2.37|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||2.370|0.305|0.76
71644959|NCT00205777|142807205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.238||||0.75|TWO_SIDED|95.0|0.332|4.616|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.||4.616|0.332|0.75
71644960|NCT00205777|142807206|SUPERIORITY_OR_OTHER||Relative Risk|0.9|||||TWO_SIDED|95.0|0.38|2.15||||||Relative risk versus placebo was provided together with 95% CIs.||2.15|0.38|
71644961|NCT00205777|142807206|SUPERIORITY_OR_OTHER||Relative Risk|0.92|||||TWO_SIDED|95.0|0.39|2.21||||||Relative risk versus placebo was provided together with 95% CIs.||2.21|0.39|
71644962|NCT00205777|142807207|SUPERIORITY_OR_OTHER||Relative risk|1.01|||||TWO_SIDED|95.0|0.5|2.06||||||Relative risk versus placebo was provided together with 95% CIs.||2.06|0.5|
71644963|NCT00205777|142807208|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Log Rank|||||||0.57
71644964|NCT00205777|142807208|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Log Rank|||||||0.62
71644965|NCT00205777|142807208|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||||||0.72
71644966|NCT00205777|142807208|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Log Rank|||||||0.67
71644967|NCT00205777|142807208|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||||||0.89
71823928|NCT03253653|143151598|OTHER||z|-4.541|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
71644968|NCT00205777|142807208|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Log Rank|||||||0.95
71644969|NCT00205777|142807209|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||||||0.29
71644970|NCT00205777|142807209|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||||||0.31
71644971|NCT00205777|142807209|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Log Rank|||||||0.94
71644972|NCT00205777|142807210|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Log Rank|||||||0.18
71644973|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.46
71644974|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.90
71644975|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.93
71644976|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.84
71644977|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.39
71644978|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.||||0.52
71644979|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.28
71644980|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.31
71644981|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.17
71644982|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.72
71644983|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.97
71644984|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Log Rank|||Hip: P value was calculated using Log-Rank test.||||0.76
71644985|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.29
71644986|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.43
71644987|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.59
71644988|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.19
71644989|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.80
71644990|NCT00205777|142807214|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.||||0.11
71644991|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.012||||0.968|TWO_SIDED|95.0|0.79|1.296|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.296|0.790|0.968
71644992|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.846||||0.211|TWO_SIDED|95.0|0.652|1.097|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.097|0.652|0.211
71644993|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.191|TWO_SIDED|95.0|0.925|1.556|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.556|0.925|0.191
71644994|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.493|TWO_SIDED|95.0|0.566|3.497|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||3.497|0.566|0.493
71644995|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872||||0.82|TWO_SIDED|95.0|0.316|2.405|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.405|0.316|0.820
71644996|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.612||||0.371|TWO_SIDED|95.0|0.624|4.161|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||4.161|0.624|0.371
71644997|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.423|TWO_SIDED|95.0|0.776|1.861|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.861|0.776|0.423
71644998|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.936||||0.799|TWO_SIDED|95.0|0.587|1.491|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg \[SE I\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.491|0.587|0.799
71644999|NCT00205777|142807215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.298|TWO_SIDED|95.0|0.818|2.002|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[Core+SE I\] versus Bazedoxifene 40/20 mg \[SE I\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||2.002|0.818|0.298
71645000|NCT00205777|142807216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.73|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.19|0.78|0.73
71645001|NCT00205777|142807216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.71|TWO_SIDED|95.0|0.41|1.83|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.83|0.41|0.71
71762713|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|2.38||||0.0092|TWO_SIDED|90.0|0.88|3.87|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||3.87|0.88|0.0092
71645002|NCT00205777|142807216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.45|TWO_SIDED|95.0|0.8|1.66|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg \[SE II\] versus Placebo \[Core+SE I+SE II\]) based on a Cox proportional hazards regression model was presented along with 95% CIs.||1.66|0.80|0.45
71645003|NCT00205777|142807217|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANCOVA|||||||0.31
71645004|NCT00205777|142807217|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
71645005|NCT00205777|142807217|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANCOVA|||||||0.13
71645006|NCT00205777|142807217|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
71645007|NCT00205777|142807217|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71645008|NCT00205777|142807218|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
71645009|NCT00205777|142807218|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
71645010|NCT00205777|142807219|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||ANCOVA|||||||0.26
71645011|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).||||<0.001
71645012|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645013|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645014|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645015|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645016|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.018
71645017|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645018|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645019|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645020|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645021|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645022|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645023|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71823929|NCT03253653|143151599|OTHER||z|-2.569||||0.01|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the 1-HOP metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||.010
71645024|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645025|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645026|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.036
71645027|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.003
71645028|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.019
71823930|NCT03253653|143151600|OTHER||z|-7.03|||<|0.001|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
71645029|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645030|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.002
71645031|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645032|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645033|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645034|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645035|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645036|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645037|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645038|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645039|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645040|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645041|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645042|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645043|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645044|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645045|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645046|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645047|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645048|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71823931|NCT03253653|143151601|OTHER||z|-1.304||||0.192|TWO_SIDED||||||Mann-Whitney U test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.192
71645049|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645050|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645051|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||0.008
71645052|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||0.007
71645053|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||0.002
71645054|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||0.002
71645055|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||0.006
71645056|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645057|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645058|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645059|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645060|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645061|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645062|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645063|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645064|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645065|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645066|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
71645067|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.005
71645068|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.002
71645069|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645070|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.004
71645071|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645072|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645073|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645074|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645075|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645076|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||0.39
71645077|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||0.17
71645078|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||0.34
71645079|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||0.016
71645080|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||0.47
71645081|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645082|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645083|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645084|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645085|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645086|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645087|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645088|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645089|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645090|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645091|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.01
71645092|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
71645093|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645094|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645095|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645096|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645097|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645098|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645099|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645100|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645101|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.048
71645102|NCT00205777|142807220|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.038
71645103|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645104|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645105|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645106|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645107|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71886230|NCT00288080|143293132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398|||||||Log Rank|||The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.||||0.0398
71645108|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645109|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645110|NCT00205777|142807220|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645111|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645112|NCT00205777|142807221|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.010
71645113|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.||||<0.001
71645114|NCT00205777|142807221|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.023
71645115|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645116|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645117|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645118|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645119|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645120|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645121|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645122|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645123|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645124|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645125|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645126|NCT00205777|142807221|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.||||<0.001
71645127|NCT00205777|142807222|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANCOVA|||Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.34
71645128|NCT00205777|142807222|SUPERIORITY_OR_OTHER|||||||0.15|||||||ANCOVA|||Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.||||0.15
71645129|NCT00205777|142807222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645130|NCT00205777|142807222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.||||<0.001
71645131|NCT00205777|142807222|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71645132|NCT00205777|142807222|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.||||<0.001
71886231|NCT00288080|143293133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||Log Rank|||Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.||||0.22
71886232|NCT00288080|143293135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Log Rank|||Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.||||0.21
71645133|NCT00205777|142807222|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.003
71645134|NCT00205777|142807222|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.||||0.002
71645135|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645136|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645137|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645138|NCT00205777|142807223|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.93
71645139|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71886233|NCT00288080|143293136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0484|||||||Log Rank|||Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.||||0.0484
71886234|NCT00087646|143293140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.006|TWO_SIDED|95.0|1.21|3.31|||Cochran-Mantel-Haenszel|||Group A Vs Group D||3.31|1.21|0.0060
71645140|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645141|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645142|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645143|NCT00205777|142807223|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.30
71645144|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645145|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645146|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645147|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645148|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645149|NCT00205777|142807223|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645150|NCT00205777|142807224|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645151|NCT00205777|142807224|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645152|NCT00205777|142807224|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645153|NCT00205777|142807224|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.||||<0.001
71645154|NCT00205777|142807225|SUPERIORITY_OR_OTHER|||||||0.037|||||||Ranked ANCOVA|||Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.037
71645155|NCT00205777|142807225|SUPERIORITY_OR_OTHER|||||||0.16|||||||Ranked ANCOVA|||Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.||||0.16
71645156|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71823932|NCT03253653|143151602|OTHER||z|-2.136||||0.033|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.033
71886235|NCT00087646|143293141|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9228|TWO_SIDED|95.0|0.63|1.51|||Cochran-Mantel-Haenszel|||||1.51|0.63|0.9228
71886236|NCT00087646|143293142|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0006|TWO_SIDED|95.0|1.4|3.52|||Cochran-Mantel-Haenszel|||||3.52|1.40|0.0006
71886237|NCT00087646|143293143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.66|4.18|||Cochran-Mantel-Haenszel|||At Week 12||4.18|1.66|<.0001
71886238|NCT00087646|143293143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1955|TWO_SIDED|95.0|0.89|1.79|||Cochran-Mantel-Haenszel|||At Week 24||1.79|0.89|0.1955
71823933|NCT03253653|143151603|OTHER||z|-1.22||||0.223|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.223
71823934|NCT03253653|143151604|OTHER||z|-7.024|||<|0.001|TWO_SIDED||||||Mann Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||<0.001
71823935|NCT03253653|143151605|OTHER||z|-1.248||||0.212|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the SPMA metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.212
71823936|NCT03253653|143151606|OTHER||z|-2.721||||0.007|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the cotinine metabolite after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.007
71823937|NCT03253653|143151607|OTHER||z|2.778||||0.006|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of exhaled carbon monoxide after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.006
71823938|NCT03253653|143151608|OTHER||z|-0.832||||0.406|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of systolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.406
71886239|NCT00087646|143293143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0883|TWO_SIDED|95.0|0.95|1.93|||Cochran-Mantel-Haenszel|||At Week 48||1.93|0.95|0.0883
71886240|NCT00087646|143293144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.67|3.19|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 12)||3.19|1.67|<.0001
71886241|NCT00087646|143293144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3389|TWO_SIDED|95.0|0.85|1.6|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 24)||1.60|0.85|0.3389
71886242|NCT01235962|143293148|SUPERIORITY||Adjusted Hazard Ratio|0.862||||0.1649|TWO_SIDED|95.0|0.699|1.063|||Stratified Log-Rank|||||1.063|0.699|0.1649
71886243|NCT01235962|143293149|SUPERIORITY||Adjusted Hazard Ratio|0.998||||0.988|TWO_SIDED|95.0|0.759|1.311|||Stratified Log-Rank|||||1.311|0.759|0.9880
71886244|NCT01235962|143293151|SUPERIORITY||Adjusted Hazard Ratio|0.802||||0.0126|TWO_SIDED|95.0|0.675|0.954|||Stratified Log-Rank|||||0.954|0.675|0.0126
71886245|NCT01235962|143293152|SUPERIORITY||Adjusted Hazard Ratio|1.001||||0.9959|TWO_SIDED|95.0|0.796|1.257|||Stratified Log-Rank|||||1.257|0.796|0.9959
71886246|NCT01235962|143293154|SUPERIORITY||Adjusted Hazard Ratio|0.693||||0.0201|TWO_SIDED|95.0|0.51|0.943|||Stratified Log-Rank|||||0.943|0.510|0.0201
71886247|NCT01235962|143293155|SUPERIORITY||Adjusted Hazard Ratio|1.004||||0.9865|TWO_SIDED|95.0|0.662|1.521|||Stratified Log-Rank|||||1.521|0.662|0.9865
71886248|NCT01235962|143293156|SUPERIORITY||Mean Difference (Week 52)|-3.397|||<|0.001|TWO_SIDED|95.0|-4.486|-2.307|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.307|-4.486|<.001
71886249|NCT01235962|143293156|SUPERIORITY||Mean Difference (24M DFS FU)|-0.043||||0.93|TWO_SIDED|95.0|-1.003|0.917|||analysis of covariance|adjusted for baseline score using mixed-model||||0.917|-1.003|0.930
71886250|NCT01235962|143293156|SUPERIORITY||Mean Difference (36M DFS FU)|0.119||||0.828|TWO_SIDED|95.0|-0.958|1.196|||analysis of covariance|adjusted for baseline score using mixed-model||||1.196|-0.958|0.828
71645157|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71823939|NCT03253653|143151609|OTHER||z|-1.467||||0.142|TWO_SIDED||||||Mann-Whitney U ranksum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of diastolic blood pressure after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.142
71823940|NCT03253653|143151610|OTHER||z|-0.596||||0.551|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the heart rate after a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.551
71823941|NCT03253653|143151611|OTHER||z|-0.787||||0.431|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.431
71823942|NCT03253653|143151612|OTHER||z|-0.652||||0.515|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.515
71886251|NCT01235962|143293156|SUPERIORITY||Mean Difference (48M DFS FU)|-0.347||||0.603|TWO_SIDED|95.0|-1.658|0.964|||analysis of covariance|adjusted for baseline score using mixed-model||||0.964|-1.658|0.603
71645158|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645159|NCT00205777|142807226|SUPERIORITY_OR_OTHER|||||||0.4|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.40
71645160|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645161|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645162|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645163|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645164|NCT00205777|142807226|SUPERIORITY_OR_OTHER|||||||0.004|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.004
71645165|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645166|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645167|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71823943|NCT03253653|143151613|OTHER||z|-2.394||||0.017|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0. 017
71645168|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645169|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645170|NCT00205777|142807226|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645171|NCT00205777|142807227|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645172|NCT00205777|142807227|SUPERIORITY_OR_OTHER|||||||0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.001
71645173|NCT00205777|142807227|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||<0.001
71645174|NCT00205777|142807227|SUPERIORITY_OR_OTHER|||||||0.009|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.009
71645175|NCT00205777|142807228|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Ranked ANCOVA|||Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.034
71645176|NCT00205777|142807228|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Ranked ANCOVA|||Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.||||0.77
71645177|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645178|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645179|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645180|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645181|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645182|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645183|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645184|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.001
71645185|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645186|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645187|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645188|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645189|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||0.009
71645190|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645191|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||0.055
71645192|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||0.004
71645193|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645194|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71886252|NCT01235962|143293156|SUPERIORITY||Mean Difference (54M DFS FU)|-0.17||||0.841|TWO_SIDED|95.0|-1.843|1.503|||analysis of covariance|adjusted for baseline score using mixed-model||||1.503|-1.843|0.841
71645195|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645196|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.||||<0.001
71645197|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71645198|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71645199|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71645200|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71645201|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71645202|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71645203|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71823944|NCT03253653|143151614|OTHER||z|-1.286||||0.199|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.199
71886253|NCT01235962|143293157|SUPERIORITY||Mean Difference (Week 52)|-1.619|||<|0.001|TWO_SIDED|95.0|-2.283|-0.955|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.955|-2.283|<.001
71886254|NCT01235962|143293157|SUPERIORITY||Mean Difference (24 M DFS FU)|-0.114||||0.726|TWO_SIDED|95.0|-0.75|0.522|||analysis of covariance|adjusted for baseline score using mixed-model||||0.522|-0.750|0.726
71645204|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71645205|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71645206|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71645207|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71645208|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71645209|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||0.012
71645210|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71645211|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||0.031
71645212|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||0.008
71645213|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.||||<0.001
71645214|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.||||<0.001
71886255|NCT01235962|143293157|SUPERIORITY||Mean Difference (36 M DFS FU)|-0.09||||0.801|TWO_SIDED|95.0|-0.789|0.609|||analysis of covariance|adjusted for baseline score using mixed-model||||0.609|-0.789|0.801
71645215|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.||||<0.001
71645216|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.||||<0.001
71645217|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
71645218|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
71645219|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.001
71645220|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
71645221|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.10
71645222|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.89
71645223|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.60
71645224|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.82
71645225|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.001
71645226|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
71645227|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.012
71645228|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
71645229|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.083
71645230|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||0.96
71886256|NCT01235962|143293157|SUPERIORITY||Meat Difference (48 M DFS FU)|-0.212||||0.617|TWO_SIDED|95.0|-1.044|0.32|||analysis of covariance|adjusted for baseline score using mixed-model||||0.320|-1.044|0.617
71645231|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.84
71645232|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||0.15
71645233|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.||||0.13
71645234|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.||||<0.001
71645235|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.||||0.007
71645236|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.||||<0.001
71823945|NCT03253653|143151615|OTHER||z|-3.091||||0.002|TWO_SIDED||||||Mann-Whitney U rank sum test||||We used the Mann-Whitney U rank sum test (two-tailed alpha level p \< 0.05), appropriate for between-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level for n=25 non-smokers.|||0.002
71823946|NCT03253653|143151616|OTHER||z|0.13||||0.896|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.896
71823947|NCT03253653|143151617|OTHER||z|-0.362||||0.717|TWO_SIDED||||||The Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.717
71823948|NCT03253653|143151618|OTHER||z|2.233||||0.026|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.026
71823949|NCT03253653|143151619|OTHER||z|0.383||||0.702|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.702
71645237|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.28
71823950|NCT03253653|143151620|OTHER||z|2.244||||0.025|TWO_SIDED||||||Wilcoxon signed rank test||||We used the Wilcoxon signed rank test (two-tailed alpha level p \< 0.05), appropriate for within-subjects analyses, to determine whether level of the furan metabolite post a tobacco smoking session for n=50 smokers differed from the level pre the tobacco smoking session.|||0.025
71645238|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA||||0.10
71645239|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.94
71645240|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.46
71645241|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.63
71645242|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.70
71645243|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.58
71645244|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.29
71645245|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.59
71645246|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.036
71645247|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.57
71645248|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.49
71645249|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.038
71645250|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.93
71645251|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.96
71645252|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.72
71645253|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.||||0.12
71823951|NCT00886613|143151672|SUPERIORITY_OR_OTHER||kappa coefficient of agreement|0.85||||0.564|TWO_SIDED|90.0|0.72|0.99|||McNemar||The significance of the difference between the proportion of subjects with a positive skin test at 48 hours and the proportion of subjects with a positive skin test at 72 hours|||0.99|0.72|0.564
71823952|NCT00886613|143151674|SUPERIORITY_OR_OTHER||Difference in proportions|0.06||||0.343|TWO_SIDED|90.0|-0.17|0.28|||Chi-squared||Statistical analysis for dose 2|||0.28|-0.17|0.343
71886257|NCT01235962|143293157|SUPERIORITY||Mean Difference (54 M DFS FU)|0.341||||0.565|TWO_SIDED|95.0|-0.828|1.51|||adjusted for baseline score using mixedm|||||1.510|-0.828|0.565
71886258|NCT01235962|143293158|SUPERIORITY||Mean Difference (Week 52)|-0.077||||0.238|TWO_SIDED|95.0|-0.205|0.051|||analysis of covariance|adjusted for baseline score using mixed-model||||0.051|-0.205|0.238
71886259|NCT01235962|143293158|SUPERIORITY||Mean Difference (24M DFS FU)|-0.052||||0.442|TWO_SIDED|95.0|-0.185|0.081|||analysis of covariance|adjusted for baseline score using mixed-model||||0.081|-0.185|0.442
71645254|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.||||0.043
71886260|NCT01235962|143293158|SUPERIORITY||Mean Difference (36M DFS FU)|0.016||||0.819|TWO_SIDED|95.0|-0.125|0.158|||analysis of covariance|adjusted for baseline score using mixed-model||||0.158|-0.125|0.819
71886261|NCT01235962|143293158|SUPERIORITY||Mean Difference (48M DFS FU)|-0.119||||0.223|TWO_SIDED|95.0|-0.311|0.073|||analysis of covariance|analysis of covariance adjusted for baseline score using mixed-model||||0.073|-0.311|0.223
71886262|NCT01235962|143293158|SUPERIORITY||Mean Difference (54M DFS FU)|-0.203||||0.085|TWO_SIDED|95.0|-0.435|0.028|||analysis of covariance|adjusted for baseline score using mixed-model||||0.028|-0.435|0.085
71886263|NCT01235962|143293159|SUPERIORITY||Mean Difference (Week 52)|-1.394|||<|0.001|TWO_SIDED|95.0|-1.66|-1.129|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.129|-1.660|<.001
71886264|NCT01235962|143293159|SUPERIORITY||Mean difference (24M DFS FU)|0.117||||0.083|TWO_SIDED|95.0|-0.015|0.249|||analysis of covariance|adjusted for baseline score using mixed-model||||0.249|-0.015|0.083
71886265|NCT01235962|143293159|SUPERIORITY||Mean Difference (36M DFS FU)|0.081||||0.307|TWO_SIDED|95.0|-0.074|0.236|||analysis of covariance|adjusted for baseline score using mixed-model||||0.236|-0.074|0.307
71886266|NCT01235962|143293159|SUPERIORITY||Mean Difference (48M DFS FU)|-0.029||||0.796|TWO_SIDED|95.0|-0.249|0.191|||analysis of covariance|adjusted for baseline score using mixed-model||||0.191|-0.249|0.796
71645255|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.||||0.53
71645256|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.||||0.75
71645257|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645258|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
71886267|NCT01235962|143293159|SUPERIORITY||Mean Difference (54M DFS FU)|-0.016||||0.885|TWO_SIDED|95.0|-0.237|0.205|||analysis of covariance|adjusted for baseline score using mixed-models||||0.205|-0.237|0.885
71886268|NCT01235962|143293160|SUPERIORITY||Mean Differencec (Week 52)|-0.27||||0.143|TWO_SIDED|95.0|-0.633|0.092|||analysis of covariance|adjusted for baseline score using mixed-model||||0.092|-0.633|0.143
71886269|NCT01235962|143293160|SUPERIORITY||Mean Difference (24M DFS FU)|0.069||||0.736|TWO_SIDED|95.0|-0.336|0.475|||analysis of covariance|adjusted for baseline score using mixed-model||||0.475|-0.336|0.736
71886270|NCT01235962|143293160|SUPERIORITY||Mean Difference (36M DFS FU)|0.188||||0.397|TWO_SIDED|95.0|-0.247|0.623|||analysis of covariance|adjusted for baseline score using mixed-model||||0.623|-0.247|0.397
71886271|NCT01235962|143293160|SUPERIORITY||Mean Difference (48M DFS FU)|0.081||||0.781|TWO_SIDED|95.0|-0.488|0.649|||analysis of covariance|adjusted for baseline score using mixed-model||||0.649|-0.488|0.781
71886272|NCT01235962|143293160|SUPERIORITY||Mean Difference (54M DFS FU)|-0.278||||0.503|TWO_SIDED|95.0|-1.094|0.539|||analysis of covariance|adjusted for baseline score using mixed-model||||0.539|-1.094|0.503
71886273|NCT01235962|143293161|SUPERIORITY||Mean Difference (Week 52 thermo)|-0.717||||0.49|TWO_SIDED|95.0|-2.751|1.318|||analysis of covariance|adjusted for baseline score using mixed-model||||1.318|-2.751|0.490
71886274|NCT01235962|143293161|SUPERIORITY||Mean Difference (24M DFS FU- thermo)|-0.285||||0.788|TWO_SIDED|95.0|-2.358|1.788|||analysis of covariance|adjusted for baseline score using mixed-model||||1.788|-2.358|0.788
71886275|NCT01235962|143293161|SUPERIORITY||Mean Difference (36M DFS FU- thermo)|1.18||||0.266|TWO_SIDED|95.0|-0.901|3.262|||analysis of covariance|adjusted for baseline score using mixed-model||||3.262|-0.901|0.266
71886276|NCT01235962|143293161|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.725||||0.57|TWO_SIDED|95.0|-1.779|3.229|||analysis of covariance|adjusted for baseline score using mixed-model||||3.229|-1.779|0.570
71886277|NCT01235962|143293161|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|2.023||||0.346|TWO_SIDED|95.0|-2.205|6.251|||analysis of covariance|adjusted for baseline score using mixed-model||||6.251|-2.205|0.346
71886278|NCT01235962|143293161|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.018||||0.111|TWO_SIDED|95.0|-0.04|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.040|0.111
71886279|NCT01235962|143293161|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.02||||0.094|TWO_SIDED|95.0|-0.044|0.003|||analysis of covariance|adjusted for baseline score using mixed-model||||0.003|-0.044|0.094
71886280|NCT01235962|143293161|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.01||||0.49|TWO_SIDED|95.0|-0.018|0.037|||analysis of covariance|adjusted for baseline score using mixed-model||||0.037|-0.018|0.490
71886281|NCT01235962|143293161|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.009||||0.58|TWO_SIDED|95.0|-0.043|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.043|0.580
71886282|NCT01235962|143293161|SUPERIORITY||Mean Difference (54M DFS FU - UI)|0.017||||0.473|TWO_SIDED|95.0|-0.029|0.063|||analysis of covariance|adjusted for baseline score using mixed-model||||0.063|-0.029|0.473
71886283|NCT01235962|143293162|SUPERIORITY||Mean Difference (Week 52)|-3.536|||<|0.001|TWO_SIDED|95.0|-4.466|-2.606|||analysis of covariance|adjusted for baseline score using mixed-model||||-2.606|-4.466|<.001
71886284|NCT01235962|143293162|SUPERIORITY||Mean difference (24M DFS FU)|-0.102||||0.812|TWO_SIDED|95.0|-0.942|0.738|||analysis of covariance|adjusted for baseline score using mixed-model||||0.738|-0.942|0.812
71886285|NCT01235962|143293162|SUPERIORITY||Mean Difference (36M DFS FU)|0.233||||0.621|TWO_SIDED|95.0|-0.69|1.155|||analysis of covariance|adjusted for baseline score using mixed-model||||1.155|-0.690|0.621
71886286|NCT01235962|143293162|SUPERIORITY||Mean Difference (48M DFS FU)|0.082||||0.878|TWO_SIDED|95.0|-0.959|1.122|||analysis of covariance|adjusted for baseline score using mixed-model||||1.122|-0.959|0.878
71886287|NCT01235962|143293162|SUPERIORITY||Mean Difference (54M DFS FU)|0.412||||0.533|TWO_SIDED|95.0|-0.887|1.712|||analysis of covariance|adjusted for baseline score using mixed-model||||1.712|-0.887|0.533
71886288|NCT01235962|143293163|SUPERIORITY||Mean Difference (Week 52)|-1.515|||<|0.001|TWO_SIDED|95.0|-2.078|-0.952|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.952|-2.078|<.001
71886289|NCT01235962|143293163|SUPERIORITY||Mean Difference (24M DFS FU)|0.014||||0.961|TWO_SIDED|95.0|-0.534|0.561|||analysis of covariance|adjusted for baseline score using mixed-model||||0.561|-0.534|0.961
71645259|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645260|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645261|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.46
71645262|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.64
71645263|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.47
71645264|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.75
71645265|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.003
71645266|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645267|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
71762714|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|0.91||||0.3174|TWO_SIDED|90.0|-0.59|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-0.59|0.3174
71645268|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645269|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.81
71645270|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||0.98
71645271|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||0.87
71645272|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||0.40
71645273|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.||||0.001
71645274|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645275|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645276|NCT00205777|142807229|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.||||<0.001
71645277|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.85
71645278|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.26
71762715|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.7344|TWO_SIDED|90.0|-1.81|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.81|0.7344
71762716|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.5881|TWO_SIDED|90.0|-1.0|1.99|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.99|-1.00|0.5881
71645279|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
71645280|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.22
71645281|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.86
71645282|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.65
71645283|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||1.00
71645284|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.44
71645285|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
71645286|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.55
71645287|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.34
71645288|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.96
71645289|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.058
71645290|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.031
71645291|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.054
71762717|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|-0.82||||0.368|TWO_SIDED|90.0|-2.32|0.68|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-2.32|0.3680
71645292|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.62
71645293|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.||||0.99
71645294|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.||||0.11
71645295|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.||||0.33
71645296|NCT00205777|142807229|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.||||0.65
71645297|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.97|||||||ANOVA|||BV: P value was calculated using Analysis of Variance (ANOVA).||||0.97
71645298|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.19
71645299|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.74
71645300|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.79
71645301|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.11
71823953|NCT04541186|143151683|SUPERIORITY||Median Percent Change Difference|-43.73|||<|0.001|TWO_SIDED|95.0|-57.08|-30.31||Significant level = 0.05|van Elteren test|Nonparametric analysis stratified by baseline TG level and background lipid therapy to test the treatment difference using pooled data.|The location shift and Hodges-Lehmann 95% confidence interval were based on Hodges-Lehman estimation. Placebo group is the reference group, and the comparison was performed in pooled pegozafermin treatment group vs. placebo pooled.|||-30.31|-57.08|<0.001
71645302|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.78
71645303|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.90
71645304|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.33
71645305|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.51
71645306|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.28
71645307|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.86
71645308|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.60
71645309|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.84
71645310|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.98
71645311|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANOVA|||OS: P value was calculated using ANOVA.||||0.47
71645312|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.59
71645313|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.13
71645314|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.65
71645315|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.33
71645316|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.053|||||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.053
71645317|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.51
71645318|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.50
71645319|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.27
71645320|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.091
71645321|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.087|||||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.087
71645322|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
71645323|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.82
71645324|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.12
71645325|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.085
71645326|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||MS: P value was calculated using ANOVA.||||0.080
71645327|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.24
71645328|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.035|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.035
71645329|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.024
71645330|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.30
71645331|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.89|||||||ANOVA|||ES: P value was calculated using ANOVA.||||0.89
71645332|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.80
71645333|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.75
71645334|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.060
71645335|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.12
71645336|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.13
71645337|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.78
71645338|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.70
71645339|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.98
71645340|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||CP: P value was calculated using ANOVA.||||0.76
71645341|NCT00205777|142807230|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||CP: P value was calculated using ANOVA.||||0.73
71645342|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.70
71645343|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANOVA|||BV: P value was calculated using ANOVA.||||0.65
71645344|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||OV: P value was calculated using ANOVA.||||0.006
71645345|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||OV: P value was calculated using ANOVA.||||0.010
71645346|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.050
71645347|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||OS: P value was calculated using ANOVA.||||0.045
71645348|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.18
71645349|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||OcS: P value was calculated using ANOVA.||||0.56
71645350|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.14
71645351|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||ObS: P value was calculated using ANOVA.||||0.22
71645352|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.11
71645353|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANOVA|||MS: P value was calculated using ANOVA.||||0.055
71645354|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.069
71645355|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||ES: P value was calculated using ANOVA.||||0.28
71645356|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.62
71645357|NCT00205777|142807231|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||OMS: P value was calculated using ANOVA.||||0.96
71645358|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.22
71645359|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.087
71645360|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.37
71645361|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.73
71645362|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||WTh: p-value was calculated using ANOVA.||||0.41
71645363|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.085
71645364|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.15
71645365|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.71
71645366|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.042
71645367|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.077
71645368|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.35
71645369|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.12
71645370|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.41
71645371|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.90
71645372|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.46
71645373|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.18
71645374|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.75
71645375|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.10
71645376|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.79
71645377|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.057
71645378|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.17
71645379|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.46
71645380|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.83
71645381|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.25
71645382|NCT00205777|142807232|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||CTh: P value was calculated using ANOVA.||||0.35
71645383|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.018
71645384|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||ANOVA|||WTh: P value was calculated using ANOVA.||||0.29
71645385|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.049
71645386|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||OTh: P value was calculated using ANOVA.||||0.37
71645387|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.97
71645388|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||TbTh: P value was calculated using ANOVA.||||0.78
71645389|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.43
71645390|NCT00205777|142807233|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANOVA|||TbSp: P value was calculated using ANOVA.||||0.32
71645391|NCT00205777|142807234|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANOVA|||||||0.35
71645392|NCT00205777|142807234|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
71645393|NCT00205777|142807234|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||||||0.30
71645394|NCT00205777|142807234|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||||||0.95
71645395|NCT00205777|142807234|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
71645396|NCT00205777|142807235|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||ANOVA|||||||1.00
71645397|NCT00205777|142807235|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||||||0.40
71645398|NCT00205777|142807236|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
71645399|NCT00205777|142807236|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
71645400|NCT00205777|142807236|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
71645401|NCT00205777|142807236|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||||||0.92
71645402|NCT00205777|142807236|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANOVA|||||||0.50
71823954|NCT04541186|143151684|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline TG level and lipid modifying therapy use.||||||<0.001
71823955|NCT04541186|143151685|SUPERIORITY||Least Squares Means Difference|-17.87|STANDARD_ERROR_OF_MEAN|6.425||0.007|TWO_SIDED|95.0|-30.67|-5.07||Significant level = 0.05|MMRM|||MMRM analysis of non-HDL-C comparison between pegozafermin pooled versus placebo pooled group.||-5.07|-30.67|0.007
71823956|NCT04541186|143151685|SUPERIORITY||Least Squares Means Difference|-11.75|STANDARD_ERROR_OF_MEAN|4.888||0.019|TWO_SIDED|95.0|-21.48|-2.01||Significant level of 0.05|MMRM|||MMRM analysis of ApoB comparison between pegozafermin pooled versus placebo pooled group.||-2.01|-21.48|0.019
71823957|NCT04541186|143151685|SUPERIORITY||Least Squares Means Difference|1.73|STANDARD_ERROR_OF_MEAN|10.519||0.87|TWO_SIDED|95.0|-19.21|22.68||Significant level = 0.05|MMRM|||MMRM analysis of LDL-C comparison between pegozafermin pooled versus placebo pooled group.||22.68|-19.21|0.870
71645403|NCT00205777|142807237|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||||||0.73
71645404|NCT00205777|142807237|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
71645405|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.81
71645406|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.96
71645407|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.005
71645408|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.013
71645409|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.006
71645410|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.70
71645411|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.44
71645412|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.47
71645413|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.28
71645414|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.14
71645415|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.93
71645416|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.85
71645417|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.010
71645418|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.015
71645419|NCT00205777|142807238|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.006
71645420|NCT00205777|142807239|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.60
71645421|NCT00205777|142807239|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||BFP: P value was calculated using ANOVA.||||0.53
71645422|NCT00205777|142807239|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||1.00
71645423|NCT00205777|142807239|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||RP: P value was calculated using ANOVA.||||0.43
71645424|NCT00205777|142807239|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.60
71645425|NCT00205777|142807239|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||ANOVA|||RmP: P value was calculated using ANOVA.||||0.52
71645426|NCT00205777|142807240|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
71645427|NCT00205777|142807240|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
71645428|NCT00205777|142807240|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
71645429|NCT00205777|142807240|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
71645430|NCT00205777|142807240|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
71645431|NCT00205777|142807241|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
71645432|NCT00205777|142807241|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
71645433|NCT00205777|142807242|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
71645434|NCT00205777|142807242|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
71645435|NCT00205777|142807242|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
71645436|NCT00205777|142807242|SUPERIORITY_OR_OTHER|||||||0.088||95.0|||||ANOVA|||||||0.088
71645437|NCT00205777|142807242|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
71645438|NCT00205777|142807243|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71645439|NCT00205777|142807243|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
71645440|NCT00205777|142807244|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.90
71645441|NCT00205777|142807244|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|||||||0.74
71645442|NCT00205777|142807244|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
71645443|NCT00205777|142807244|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
71645444|NCT00205777|142807244|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||||||0.24
71645445|NCT00205777|142807245|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71645446|NCT00205777|142807245|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|||||||0.070
71645447|NCT00205777|142807246|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||ANOVA|||||||0.77
71645448|NCT00205777|142807246|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||||||0.91
71645449|NCT00205777|142807246|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
71823958|NCT04541186|143151685|SUPERIORITY||Least Squares Means Difference|15.41|STANDARD_ERROR_OF_MEAN|8.182||0.064|TWO_SIDED|95.0|-0.89|31.7||Significant level = 0.05|MMRM|||MMRM analysis of HDL-C comparison between pegozafermin pooled versus placebo pooled group.||31.70|-0.89|0.064
71823959|NCT04541186|143151686|SUPERIORITY|||||||0.006||||||Significant level = 0.05|van Elteren Test|||Nonparametric analysis of VLDL-C comparison between pegozafermin pooled versus placebo pooled group.||||0.006
71823960|NCT04541186|143151686|SUPERIORITY|||||||0.002||||||Significant level of 0.05|van Elteren test|||Nonparametric analysis of VLDL-TG comparison between pegozafermin pooled versus placebo pooled group.||||0.002
71823961|NCT04541186|143151687|SUPERIORITY|||||||0.809||||||Significant level = 0.05|MMRM|||MMRM analysis of fasting plasma glucose comparison between pegozafermin pooled versus placebo pooled group.||||0.809
71886290|NCT01235962|143293163|SUPERIORITY||Mean Difference (36M DFS FU)|0.043||||0.888|TWO_SIDED|95.0|-0.555|0.641|||analysis of covariance|adjusted for baseline score using mixed-model||||0.641|-0.555|0.888
71886291|NCT01235962|143293163|SUPERIORITY||Mean Difference (48M DFS FU)|-0.061||||0.858|TWO_SIDED|95.0|-0.736|0.614|||analysis of covariance|adjusted for baseline score using mixed-model||||0.614|-0.736|0.858
71886292|NCT01235962|143293163|SUPERIORITY||Mean Difference (54M DFS FU)|0.452||||0.3|TWO_SIDED|95.0|-0.404|1.309|||analysis of covariance|adjusted for baseline score using mixed-model||||1.309|-0.404|0.300
71645450|NCT00205777|142807246|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
71645451|NCT00205777|142807246|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||||||0.012
71645452|NCT00205777|142807247|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
71823962|NCT04541186|143151687|SUPERIORITY||||||<|0.001||||||Significant level = 0.05|MMRM|||MMRM analysis of adiponectin comparison between pegozafermin pooled versus placebo pooled group.||||<0.001
71823963|NCT04541186|143151687|SUPERIORITY|||||||0.973||||||Significant level = 0.05|MMRM|||MMRM analysis of body weight comparison between pegozafermin pooled versus placebo pooled group.||||0.973
71823964|NCT04541186|143151688|SUPERIORITY|||||||0.012||||||Significant level = 0.05|ANCOVA|||||||0.012
71823965|NCT00058058|143151701|OTHER|Estimation of diagnostic yield|Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS||0.042|0.020|
71823966|NCT00058058|143151701|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.044||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up||0.044|0.021|
71823967|NCT00058058|143151701|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure||0.042|0.020|
71823968|NCT00058058|143151701|OTHER||Binomial proportion|0.031|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan||0.042|0.020|
71645453|NCT00205777|142807247|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71645454|NCT00205777|142807248|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||||||0.30
71645455|NCT00205777|142807248|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||||||0.62
71645456|NCT00205777|142807248|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
71645457|NCT00205777|142807248|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||0.041
71645458|NCT00205777|142807248|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
71645459|NCT00205777|142807249|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANOVA|||||||0.70
71645460|NCT00205777|142807249|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71645461|NCT00205777|142807250|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
71645462|NCT00205777|142807250|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||||||0.76
71645463|NCT00205777|142807250|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||||||0.26
71645464|NCT00205777|142807250|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||||||0.89
71886293|NCT01235962|143293164|SUPERIORITY||Mean Difference (Week 52)|-0.103||||0.059|TWO_SIDED|95.0|-0.211|0.004|||analysis of covariance|adjusted for baseline score using mixed-model||||0.004|-0.211|0.059
71886294|NCT01235962|143293164|SUPERIORITY||Mean Difference (24M DFS FU)|-0.041||||0.487|TWO_SIDED|95.0|-0.155|0.074|||analysis of covariance|adjusted for baseline score using mixed-model||||0.074|-0.155|0.487
71886295|NCT01235962|143293164|SUPERIORITY||Mean Difference (36M DFS FU)|0.037||||0.885|TWO_SIDED|95.0|-0.085|0.16|||analysis of covariance|adjusted for baseline score using mixed-model||||0.160|-0.085|0.885
71886296|NCT01235962|143293164|SUPERIORITY||Mean Difference (48M DFS FU)|-0.032||||0.676|TWO_SIDED|95.0|-0.183|0.119|||analysis of covariance|adjusted for baseline score using mixed-model||||0.119|-0.183|0.676
71886297|NCT01235962|143293164|SUPERIORITY||Mean Difference (54M DFS FU)|-0.015||||0.859|TWO_SIDED|95.0|-0.183|0.153|||analysis of covariance|adjusted for baseline score using mixed-model||||0.153|-0.183|0.859
71886298|NCT01235962|143293165|SUPERIORITY||Mean Diffeence (Week 52)|-1.535|||<|0.001|TWO_SIDED|95.0|-1.769|-1.3|||analysis of covariance|adjusted for baseline score using mixed-model||||-1.300|-1.769|<.001
71886299|NCT01235962|143293165|SUPERIORITY||Mean Diffeence (24M DFS FU)|0.089||||0.127|TWO_SIDED|95.0|-0.025|0.202|||analysis of covariance|adjusted for baseline score using mixed-model||||0.202|-0.025|0.127
71886300|NCT01235962|143293165|SUPERIORITY||Mean Diffeence (36M DFS FU)|0.123||||0.069|TWO_SIDED|95.0|-0.009|0.255|||analysis of covariance|adjusted for baseline score using mixed-model||||0.255|-0.009|0.069
71886301|NCT01235962|143293165|SUPERIORITY||Mean Diffeence (48M DFS FU)|0.049||||0.544|TWO_SIDED|95.0|-0.11|0.208|||analysis of covariance|adjusted for baseline score using mixed-model||||0.208|-0.110|0.544
71645465|NCT00205777|142807250|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||ANOVA|||||||0.17
71645466|NCT00205777|142807251|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
71645467|NCT00205777|142807251|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||||||0.18
71645468|NCT00205777|142807252|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
71645469|NCT00205777|142807252|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71645470|NCT00205777|142807252|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.050
71645471|NCT00205777|142807252|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||ANOVA|||||||0.061
71645472|NCT00205777|142807252|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
71645473|NCT00205777|142807253|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|||||||0.15
71645474|NCT00205777|142807253|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANOVA|||||||0.056
71762718|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.42|TWO_SIDED|90.0|-2.23|0.76|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.76|-2.23|0.4200
71645475|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.20
71645476|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.12
71645477|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.17
71645478|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.92
71645479|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.||||0.86
71645480|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.18
71645481|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.12
71645482|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.096
71645483|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.76
71645484|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.||||0.93
71645485|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.36
71645486|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.34
71645487|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.98
71645488|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
71645489|NCT00205777|142807255|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.||||0.35
71645490|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.080
71762719|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|-3.03||||0.0009|TWO_SIDED|90.0|-4.53|-1.53|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-1.53|-4.53|0.0009
71645491|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.41
71645492|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.65
71645493|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.18
71645494|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.||||0.36
71645495|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.27
71645496|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.25
71645497|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.053
71645498|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.40
71645499|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.||||0.45
71645500|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.012
71645501|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.54
71645502|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.11
71645503|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.35
71645504|NCT00205777|142807257|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.||||0.34
71645505|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.21
71645506|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.058
71645507|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.76
71886302|NCT01235962|143293165|SUPERIORITY||Mean Difference (54M DFS FU)|0.061||||0.518|TWO_SIDED|95.0|-0.124|0.246|||analysis of covariance|adjusted for baseline score using mixed-model||||0.246|-0.124|0.518
71645508|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.34
71645509|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.||||0.51
71645510|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.14
71645511|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.57
71645512|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
71645513|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.24
71645514|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.||||0.78
71645515|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.62
71645516|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.72
71645517|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.16
71645518|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.059
71645519|NCT00205777|142807259|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.||||0.30
71645520|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.72
71645521|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.98
71762720|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|4.46|||<|0.0001|TWO_SIDED|90.0|2.96|5.97|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.97|2.96|< 0.0001
71762721|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|5.83|||<|0.0001|TWO_SIDED|90.0|4.32|7.33|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||7.33|4.32|< 0.0001
71645522|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.84
71645523|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.88
71645524|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.||||0.86
71645525|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.82
71645526|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.11
71645527|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.14
71645528|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.22
71645529|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.||||0.88
71645530|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.96
71645531|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.76
71645532|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.92
71645533|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.89
71645534|NCT00205777|142807261|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.||||0.83
71645535|NCT00367133|142807263|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P values for two group comparisons for difference in mean change.||||0.02
71645536|NCT00367133|142807263|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.002
71645537|NCT00367133|142807263|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change||||0.49
71645538|NCT00367133|142807266|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.03
71645539|NCT00367133|142807266|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.01
71645540|NCT00367133|142807266|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening||||0.82
71645541|NCT00367133|142807267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P value not adjusted for multiple comparisons||||<0.001
71762722|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.0001|TWO_SIDED|90.0|2.58|5.59|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||5.59|2.58|< 0.0001
71823969|NCT00058058|143151701|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan||0.043|0.021|
71645542|NCT00367133|142807267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||<0.001
71645543|NCT00367133|142807267|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||0.91
71645544|NCT00367133|142807269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
71645545|NCT00367133|142807269|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
71645546|NCT00367133|142807269|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons||||0.60
71645547|NCT00367133|142807270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons||||<0.001
71645548|NCT00367133|142807270|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||<0.001
71645549|NCT00367133|142807270|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis||||0.55
71645550|NCT00836758|142807278|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71645551|NCT00906399|142807280|SUPERIORITY_OR_OTHER||Rate Ratio|0.725||||0.0114|TWO_SIDED|95.0|0.565|0.93|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40 years).||||0.930|0.565|0.0114
71645552|NCT00906399|142807280|SUPERIORITY_OR_OTHER||Rate Ratio|0.644||||0.0007|TWO_SIDED|95.0|0.5|0.831|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (\< 4 versus ≥ 4), baseline relapse rate, age (\< 40 versus ≥ 40).||||0.831|0.500|0.0007
71886303|NCT01235962|143293166|SUPERIORITY||Mean Diffeence (Week 52)|-0.374||||0.022|TWO_SIDED|95.0|-0.695|-0.053|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.053|-0.695|0.022
71645553|NCT00906399|142807281|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.72||||0.0008|TWO_SIDED|95.0|0.6|0.87|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.87|0.60|0.0008
71645554|NCT00906399|142807281|SUPERIORITY_OR_OTHER||Lesion Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.27|0.4|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.||||0.40|0.27|<0.0001
71645555|NCT00906399|142807282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.02|TWO_SIDED|95.0|0.57|0.95||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.95|0.57|0.0200
71645556|NCT00906399|142807282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0003|TWO_SIDED|95.0|0.47|0.8||Based on Cox proportion hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4), age (\<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model|||||0.80|0.47|0.0003
71645557|NCT00906399|142807283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.038|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0380
71645558|NCT00906399|142807283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0383|TWO_SIDED|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (\< 4 versus ≥ 4) and age (\< 40 versus ≥ 40 years).|Cox Proportion Hazards model|||||0.97|0.40|0.0383
71645559|NCT01124786|142807284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994|||<|0.973|TWO_SIDED|95.0|0.746|1.326|||Log Rank||Hazard ratio and confidence interval presented above, so parameter dispersion not indicated in standard deviation field directly above.|If the median Overall Survival (OS) for the CO-1.01-treated patients is 7.7 months and the median OS for gemcitabine-treated patients with hENT1-low status is 4 months (hazard ratio of 0.53), then a total of 144 events of death in the hENT1-low subgroup will provide over 90% power at a 0.05 (2 sided) significance level for the comparison of CO-1.01 to gemcitabine in the hENT1-low patients.||1.326|0.746|<0.973
71645560|NCT01665508|142807303|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were reported as the mean ± (SD) and categorical data presented as frequency and percentage of the sample. Comparisons between baseline and post-treatment SAQ scores, SF-36v2 scores, and CPET variables were performed using a paired t-test for normally distributed variables or a Wilcoxon signed-rank test for non-normally distributed variables. Normality was defined by the Shapiro-Wilk test. For categorical variables, data were compared using a chi-squared test.||||< 0.05
71645561|NCT00858780|142807312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.17||||0.007|TWO_SIDED|95.0|1.72|29.82|||GEE Model|||Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||29.82|1.72|0.007
71645562|NCT00858780|142807312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.362|TWO_SIDED|95.0|0.54|5.41|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||5.41|0.54|0.362
71823970|NCT00058058|143151701|OTHER||Binomial Proportion|0.032|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up||0.043|0.021|
71645563|NCT00858780|142807312|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2||||0.044|TWO_SIDED|95.0|1.04|16.99|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.||16.99|1.04|0.044
71645564|NCT02615249|142807335|OTHER||Kappa statistic|0.28|||||TWO_SIDED|95.0|-0.01|0.58||||||Comparison between 0.12 mg/cm2 copper sulfate and copper sulfate 2% in petrolatum||0.58|-0.01|
71645565|NCT02615249|142807335|OTHER||Kappa statistic|0.45|||||TWO_SIDED|95.0|0.24|0.66||||||Comparison between 0.24 mg/cm2 manganese chloride and manganese chloride 2% in petrolatum||0.66|0.24|
71645566|NCT02615249|142807335|OTHER||Kappa statistic|0.23|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.33 mg/cm2 tin chloride vs 1% tin chloride in petrolatum reference allergen|Comparison between 0.33 mg/cm2 tin chloride and tin chloride 1% in petrolatum||0.38|0.07|
71645567|NCT02615249|142807335|OTHER||Kappa statistic|0.4|||||TWO_SIDED|95.0|0.15|0.65|||||Kappa statistic is for 0.22 mg Ti/cm2 ammonium titanium oxide oxalate vs 19% ammonium titanium oxide oxalate in petrolatum reference allergen|Comparison between 0.22 mg Ti/cm2 ammonium titanium oxide oxalate and ammnium titanium oxide oxalate 19% in petrolatum||0.65|0.15|
71645568|NCT02615249|142807335|OTHER||Kappa statistic|0.52|||||TWO_SIDED|95.0|0.3|0.73|||||Kappa statistic is for 0.050 mg V/cm2 vanadium sulfate vs 1.5% vanadium sulfate in petrolatum reference allergen|Comparison between 0.050 mg/cm2 vanadium sulfate and vanadium sulfate 1.5% in petrolatum||0.73|0.30|
71645569|NCT02615249|142807335|OTHER||Kappa statistic|0.36|||||TWO_SIDED|95.0|0.07|0.38|||||Kappa statistic is for 0.24 mg/cm2 zinc chloride vs 2% zinc chloride in petrolatum reference allergen|Comparison betweenm 0.24 mg/cm2 zinc chloride and zinc chloride 2% in petrolatum||0.38|0.07|
71645570|NCT02055547|142807392|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|4.61|||<|0.001|TWO_SIDED|90.0|3.69|5.76|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|5.76|3.69|<0.001
71645571|NCT02055547|142807392|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|2.67|||<|0.001|TWO_SIDED|90.0|2.12|3.36|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|3.36|2.12|<0.001
71645572|NCT02055547|142807392|OTHER|"Treatment comparison (MK-8521 125μg - MK-8521 35μg) of the slope of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of the slope of ISR/G for MK-8521 125μg vs.~MK-8521 35μg was calculated from the model."|Geometric mean ratio|1.73|||<|0.001|TWO_SIDED|90.0|1.38|2.16|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|2.16|1.38|<0.001
71645573|NCT02055547|142807393|OTHER|Treatment comparison (MK-8521 125μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg vs. placebo was calculated from the model.|Geometric mean ratio|3.04|||<|0.001|TWO_SIDED|90.0|2.62|3.53|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|3.53|2.62|<0.001
71645574|NCT02055547|142807393|OTHER|Treatment comparison (MK-8521 35μg - placebo) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 35μg vs. placebo was calculated from the model.|Geometric mean ratio|1.94|||<|0.001|TWO_SIDED|90.0|1.67|2.26|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|2.26|1.67|<0.001
71645575|NCT02055547|142807393|OTHER|Treatment comparison (MK-8521 125μg - 35μg) of the ratio of ISR/G during GGI at Tmax was performed using a linear mixed effect model with treatment and period as fixed effects and participant as random effect. The 90% confidence interval of GMR of TWA120-160min of ratio (ISR/G) for MK-8521 125μg - 35μg was calculated from the model.|Geometric mean ratio|1.57|||<|0.001|TWO_SIDED|90.0|1.35|1.82|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|1.82|1.35|<0.001
71823971|NCT00058058|143151702|OTHER||Binomial Proportion|0.9091|STANDARD_ERROR_OF_MEAN|0.05004|||TWO_SIDED|95.0|0.7567|0.9809||||||"Sensitivity estimate - estimates the P(T+\|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9809|0.7567|
71645576|NCT02055547|142807394|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125mcg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.65|||<|0.001|TWO_SIDED|90.0|0.6|0.7|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.7|0.6|<0.001
71823972|NCT00058058|143151702|OTHER||Binomial Proportion|0.8782|STANDARD_ERROR_OF_MEAN|0.0107|||TWO_SIDED|95.0|0.8555|0.8985||||||"Specificity - estimates the P(T-\|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.8985|0.8555|
71823973|NCT00058058|143151702|OTHER||Binomial Proportion|0.2083|STANDARD_ERROR_OF_MEAN|0.0338|||TWO_SIDED|95.0|0.1452|0.2839||||||"PPV estimate - estimates the P(D+\|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)."||0.2839|0.1452|
71645577|NCT02055547|142807394|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.74|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.74|<0.001
71645578|NCT02055547|142807394|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in glucose (TWA0-160min) after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.81|||<|0.001|TWO_SIDED|90.0|0.75|0.87|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3-period crossover study design was conducted for 12 participants in Part 3).|0.87|0.75|<0.001
71645579|NCT02055547|142807395|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg vs. placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.55|||<|0.001|TWO_SIDED|90.0|0.49|0.63|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.63|0.49|<0.001
71645580|NCT02055547|142807395|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 35μg - placebo) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.81|0.62|<0.001
71645581|NCT02055547|142807395|OTHER|The least squares means and 90% confidence intervals for the treatment difference (MK-8521 125μg - MK-8521 35μg) in Gmax after a single dose was determined using a linear mixed effect model with treatment and period as fixed effects and participant as random effect.|Geometric mean ratio|0.78||||0.004|TWO_SIDED|90.0|0.69|0.89|||Linear mixed effect model||||Number of participants included in analysis: N=17 (3 period crossover study design was conducted for 12 participants in Part 3).|0.89|0.69|0.004
71645582|NCT01248728|142807441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
71645583|NCT01248728|142807442|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71645584|NCT01248728|142807444|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71645585|NCT01248728|142807445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Regression, Linear|||||||0.6
71645586|NCT01838681|142807468|SUPERIORITY||Odds Ratio (OR)|0.83||||0.2641|TWO_SIDED|95.0|0.6|1.15|||Regression, Logistic|Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used||||1.15|0.60|0.2641
71645587|NCT04198363|142807489|NON_INFERIORITY|Noninferiority of vonoprazan to esomeprazole was evaluated by Farrington and Manning test using a noninferiority margin of 10% for analysis.|Difference in Proportions|0.1|||=|0.0009|TWO_SIDED|95.0|-5.95|6.17|||Farrington and Manning Test||Difference in proportions for vonoprazan versus esomeprazole was analyzed and the 2-sided Wald confidence interval was used for determining the 95% confidence interval.|||6.17|-5.95|=0.0009
71645588|NCT03067987|142807500|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
71645589|NCT03067987|142807501|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
71645590|NCT03442322|142807504|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.25||||0.492|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.492
71645591|NCT03442322|142807505|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.73||||0.765|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.765
71823974|NCT00058058|143151702|OTHER||Binomial Proportion|0.9964|STANDARD_ERROR_OF_MEAN|0.0021|||TWO_SIDED|95.0|0.9894|0.9993||||||"B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-\|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"||0.9993|0.9894|
71645592|NCT03442322|142807506|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.77||||0.808|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.808
71645593|NCT03442322|142807507|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.86||||0.108|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.108
71645594|NCT03442322|142807508|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|2.59||||0.411|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.411
71645595|NCT03442322|142807509|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.08||||0.981|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.981
71645596|NCT03442322|142807510|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|3.51||||0.02|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.020
71886304|NCT01235962|143293166|SUPERIORITY||Mean Diffeence (24M DFS FU)|-0.104||||0.567|TWO_SIDED|95.0|-0.462|0.253|||analysis of covariance|adjusted for baseline score using mixed-model||||0.253|-0.462|0.567
71645597|NCT03442322|142807511|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.62||||0.299|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.299
71645598|NCT03442322|142807512|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.68||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.389
71645599|NCT03442322|142807513|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.14||||0.389|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.389
71645600|NCT03442322|142807514|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-5.95||||0.043|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.043
71645601|NCT03442322|142807515|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.91||||0.279|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.279
71645602|NCT03442322|142807516|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|0.92||||0.728|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.728
71645603|NCT03442322|142807517|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.75||||0.49|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.490
71645604|NCT03442322|142807518|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|4.44||||0.232|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.232
71645605|NCT03442322|142807519|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.11||||0.708|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.708
71645606|NCT03442322|142807520|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.0||||0.775|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.775
71645607|NCT03442322|142807521|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|1.77||||0.584|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.584
71645608|NCT03442322|142807522|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-0.25||||0.898|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.898
71645609|NCT03442322|142807523|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.79||||0.217|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.217
71645610|NCT03442322|142807524|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-1.39||||0.56|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.560
71645611|NCT03442322|142807525|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.08||||0.277|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics and nursing home fixed effects.||||||0.277
71645612|NCT03442322|142807526|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-2.53||||0.4|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.400
71645613|NCT03442322|142807527|OTHER|Given that we found baseline differences in resident characteristics and outcomes, we implemented a difference-in-differences model for all outcomes.|Difference-in-Difference estimator|-3.18||||0.303|TWO_SIDED||||||Regression, Linear|All regressions controlled for resident characteristics, nursing home staffing, resident COVID cases, and nursing home fixed effects.||||||0.303
71645614|NCT01404988|142807528|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||For this pilot study, the Type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.1
71645615|NCT01404988|142807528|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2
71645616|NCT01404988|142807529|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||.3
71645617|NCT01404988|142807529|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.77
71645618|NCT01404988|142807530|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)|||||||0.03
71823975|NCT00058058|143151702|OTHER||Binomial Proportion|0.031|STANDARD_ERROR_OF_MEAN|0.00556|||TWO_SIDED|95.0|0.021|0.044||||||B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis||0.044|0.021|
71823976|NCT00058058|143151703|OTHER||ROC analysis|0.9355|||||TWO_SIDED|95.0|0.8956|0.9753|||||exact CI|ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast||0.9753|0.8956|
71823977|NCT00790062|143151722|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.67|TWO_SIDED|95.0|0.63|1.59|||ANCOVA|||||1.59|0.63|0.670
71823978|NCT01119703|143151734|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.1|||||TWO_SIDED|95.0|-13.8|-0.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||-0.7|-13.8|
71823979|NCT01119703|143151735|SUPERIORITY_OR_OTHER||Coefficient of Determination %|17.6|||||TWO_SIDED|95.0|10.6|20.9|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||20.9|10.6|
71823980|NCT01119703|143151736|SUPERIORITY_OR_OTHER||Coefficient of Determination %|27.8|||||TWO_SIDED|95.0|19.6|32.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||32.4|19.6|
71823981|NCT01119703|143151737|SUPERIORITY_OR_OTHER||Coefficient of Determination %|3.3||||||95.0|-2.8|8.5|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.||8.5|-2.8|
71823982|NCT01119703|143151738|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.04||||0.66|TWO_SIDED|95.0|-0.2|0.13|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Hepatitis B||0.13|-0.2|0.66
71823983|NCT01119703|143151738|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.1||||0.26|TWO_SIDED|95.0|-0.07|0.25|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Cholera||0.25|-0.07|0.26
71823984|NCT01119703|143151738|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.53|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Tetanus||0.53|0.26|<0.001
71823985|NCT01119703|143151738|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.17||||0.04|TWO_SIDED|95.0|-0.32|-0.01|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Cholera||-0.01|-0.32|0.04
71823986|NCT01119703|143151738|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.09||||0.3|TWO_SIDED|95.0|-0.25|0.08|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Tetanus||0.08|-0.25|0.30
71823987|NCT01119703|143151738|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.08||||0.36|TWO_SIDED|95.0|-0.09|0.24|||Fisher's Z-transformation||Within-participant rank correlation|Cholera versus Tetanus||0.24|-0.09|0.36
71823988|NCT01119703|143151739|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-9.5|||||TWO_SIDED|95.0|-16.6|-2.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||-2.7|-16.6|
71823989|NCT01119703|143151740|SUPERIORITY_OR_OTHER||Coefficient of Determination %|23.7|||||TWO_SIDED|95.0|14.0|29.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||29.7|14.0|
71823990|NCT01119703|143151741|SUPERIORITY_OR_OTHER||Coefficient of Determination %|36.7|||||TWO_SIDED|95.0|28.7|41.5|||||Crossvalidated;negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||41.5|28.7|
71823991|NCT01119703|143151742|SUPERIORITY_OR_OTHER||Coefficient of Determination %|-2.2|||||TWO_SIDED|95.0|-7.8|4.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) \<= 20%; whereas the alternative hypothesis is \> 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.||4.4|-7.8|
71823992|NCT03124108|143151760|SUPERIORITY||Difference in percentage|-52.0|STANDARD_ERROR_OF_MEAN|5.4|<|0.001|TWO_SIDED|95.0|-62.5|-41.5|||ANCOVA|||||-41.5|-62.5|<0.001
71823993|NCT03124108|143151760|SUPERIORITY||Difference in percentage|-43.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-55.7|-32.1|||ANCOVA|||||-32.1|-55.7|<0.001
71823994|NCT03643965|143151821|OTHER|Ratio of UPCR at 9 months compared to baseline for Nefecon compared to Placebo|Ratio of geometric LS means|0.73||||0.0003|TWO_SIDED|96.0|0.61|0.88|||MMRM model|||||0.88|0.61|0.0003
71823995|NCT03643965|143151822|OTHER|Time-weighted average of eGFR, Nefecon compared to Placebo|Ratio of geometric LS means|1.1|||<|0.0001|TWO_SIDED|95.0|1.06|1.15|||robust regression|||||1.15|1.06|<0.0001
71823996|NCT03643965|143151823|OTHER|Ratio of eGFR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0014|TWO_SIDED|95.0|1.03|1.13|||robust regression|||||1.13|1.03|0.0014
71823997|NCT03643965|143151824|OTHER|Ratio of eGFR at 12 months comparison of Nefecon to Placebo|Ratio of geometric LS means|1.07||||0.0106|TWO_SIDED|95.0|1.01|1.13|||robust regression|||||1.13|1.01|0.0106
71645619|NCT01404988|142807530|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.06
71645620|NCT01404988|142807531|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||For this pilot study, type 1 error was set at 5%|Fisher Exact|||||||0.60
71645621|NCT01404988|142807531|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
71645622|NCT00373256|142807548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6299||||0.9986|TWO_SIDED|95.0|1.1793|2.2527||p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.|Log Rank||Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.|||2.2527|1.1793|0.9986
71645623|NCT00373256|142807549|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.2|||||TWO_SIDED|95.0|26.4|38.5||||||||38.5|26.4|
71645624|NCT00373256|142807549|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|32.1|||||TWO_SIDED|95.0|26.3|38.4||||||||38.4|26.3|
71645625|NCT00373256|142807552|SUPERIORITY_OR_OTHER||Percentage|76.8|||||TWO_SIDED|95.0|68.7|83.0||||||1 year||83.0|68.7|
71645626|NCT00373256|142807552|SUPERIORITY_OR_OTHER||Percentage|35.5|||||TWO_SIDED|95.0|20.9|50.3||||||2 years||50.3|20.9|
71645627|NCT00373256|142807552|SUPERIORITY_OR_OTHER||Percentage|83.7|||||TWO_SIDED|95.0|76.0|89.1||||||1 year||89.1|76.0|
71645628|NCT00373256|142807552|SUPERIORITY_OR_OTHER||Percentage|61.0|||||TWO_SIDED|95.0|43.2|74.7||||||2 years||74.7|43.2|
71645629|NCT02645253|142807565|SUPERIORITY_OR_OTHER||Slope|1.02|STANDARD_ERROR_OF_MEAN|0.0785|||TWO_SIDED|90.0|0.882|1.15|||Linear Model|||||1.15|0.882|
71645630|NCT02645253|142807567|SUPERIORITY_OR_OTHER||Slope|1.14|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|90.0|1.06|1.23|||Linear Model|||||1.23|1.06|
71645631|NCT02645253|142807569|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|90.0|0.801|1.31|||Linear Model|||||1.31|0.801|
71645632|NCT02645253|142807579|SUPERIORITY_OR_OTHER||Slope|0.979|STANDARD_ERROR_OF_MEAN|0.0633|||TWO_SIDED|90.0|0.87|1.09|||Linear Model|||||1.09|0.870|
71645633|NCT02645253|142807584|SUPERIORITY_OR_OTHER||Slope|1.05|STANDARD_ERROR_OF_MEAN|0.0552|||TWO_SIDED|90.0|0.951|1.14|||Linear Model|||||1.14|0.951|
71645634|NCT02645253|142807596|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|102.99|||||TWO_SIDED|95.0|86.88|122.09|||ANCOVA||Day 1/ Day -1|||122.09|86.88|
71645635|NCT02645253|142807596|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|91.82|||||TWO_SIDED|95.0|77.32|109.04|||ANCOVA||Day 16 / Day -1|||109.04|77.32|
71645636|NCT02645253|142807596|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|105.92|||||TWO_SIDED|95.0|89.4|125.49|||ANCOVA||Day 1 / Day -1|||125.49|89.40|
71645637|NCT02645253|142807596|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|89.44|||||TWO_SIDED|95.0|75.35|106.16|||ANCOVA||Day 16 / Day -1|||106.16|75.35|
71645638|NCT02645253|142807596|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|99.82|||||TWO_SIDED|95.0|84.12|118.46|||ANCOVA||Day 1 / Day -1|||118.46|84.12|
71645639|NCT02645253|142807596|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean (%)|75.38||||||95.0|63.4|89.61|||ANCOVA||Day 16 / Day -1|||89.61|63.40|
71645640|NCT05497557|142807602|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.677|||||TWO_SIDED|90.0|0.547|0.839||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.839|0.547|
71645641|NCT05497557|142807603|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.771|||||TWO_SIDED|90.0|0.628|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.628|
71702370|NCT01121926|142921751|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCss is between 80% and 125%.|Mean ratio|85.72|||||TWO_SIDED|90.0|81.05|90.67|||||Test/reference (%)|||90.67|81.05|
71645642|NCT05497557|142807604|OTHER|Drug-drug Interaction Assessment|Ratio of geometric least squares mean|0.766|||||TWO_SIDED|90.0|0.619|0.948||||||Ratios of geometric least squares means, and corresponding confidence intervals were obtained by taking the exponential of the least square means (LSMs), differences in LSMs, and corresponding confidence intervals on the natural log (ln) scale.||0.948|0.619|
71645643|NCT02752074|142807606|OTHER||Hazard Ratio (HR)|1.0||||0.51711|TWO_SIDED|95.0|0.83|1.21||One-sided p-value based on log-rank test.|Log Rank|||||1.21|0.83|0.51711
71645644|NCT02752074|142807607|OTHER||Hazard Ratio (HR)|1.13||||0.80666|TWO_SIDED|95.0|0.86|1.49||One-sided p-value based on log-rank test.|Log Rank|||||1.49|0.86|0.80666
71645645|NCT00907907|142807620|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.97||||||90.0|80.25|110.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.04|80.25|
71645646|NCT00907907|142807621|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|102.01||||||90.0|98.74|105.39|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.39|98.74|
71645647|NCT00907907|142807622|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.91||||||90.0|95.99|103.98|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.98|95.99|
71645648|NCT00545792|142807624|SUPERIORITY_OR_OTHER||Single point estiamte of 1-yr PFS|0.8|||||TWO_SIDED|95.0|0.56|0.94|||||The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.|Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.||0.94|0.56|
71645649|NCT06078501|142807631|OTHER|||||||0.695||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.695
71702371|NCT01149785|142921816|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|316.36|||||TWO_SIDED|90.0|286.17|349.73||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||349.73|286.17|
71886305|NCT01235962|143293166|SUPERIORITY||Mean Difference (36M DFS FU)|0.072||||0.706|TWO_SIDED|95.0|-0.302|0.446|||analysis of covariance|adjusted for baseline score using mixed-model||||0.446|-0.302|0.706
71886306|NCT01235962|143293166|SUPERIORITY||Mean Difference (48M DFS FU)|0.12||||0.612|TWO_SIDED|95.0|-0.343|0.583|||analysis of covariance|adjusted for baseline score using mixed-model||||0.583|-0.343|0.612
71886307|NCT01235962|143293166|SUPERIORITY||Mean Difference (54M DFS FU)|-0.045||||0.87|TWO_SIDED|95.0|-0.587|0.496|||analysis of covariance|adjusted for baseline score using mixed-model||||0.496|-0.587|0.870
71886308|NCT01235962|143293167|SUPERIORITY||Mean Difference (Week 52 - thermo.)|-2.116||||0.018|TWO_SIDED|95.0|-3.872|-0.359|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.359|-3.872|0.018
71886309|NCT01235962|143293167|SUPERIORITY||Mean Difference (24M DFS FU - thermo)|-0.253||||0.778|TWO_SIDED|95.0|-2.014|1.508|||analysis of covariance|adjusted for baseline score using mixed-model||||1.508|-2.014|0.778
71886310|NCT01235962|143293167|SUPERIORITY||Mean Difference (36M DFS FU - thermo)|0.847||||0.376|TWO_SIDED|95.0|-1.03|2.724|||analysis of covariance|adjusted for baseline score using mixed-model||||2.724|-1.030|0.376
71886311|NCT01235962|143293167|SUPERIORITY||Mean Difference (48M DFS FU - thermo)|0.131||||0.905|TWO_SIDED|95.0|-2.032|2.294|||analysis of covariance|adjusted for baseline score using mixed-model||||2.294|-2.032|0.905
71886312|NCT01235962|143293167|SUPERIORITY||Mean Difference (54M DFS FU - thermo)|0.401||||0.768|TWO_SIDED|95.0|-2.269|3.071|||analysis of covariance|adjusted for baseline score using mixed-model||||3.071|-2.269|0.768
71886313|NCT01235962|143293167|SUPERIORITY||Mean Difference (Week 52 - UI)|-0.026||||0.007|TWO_SIDED|95.0|-0.044|-0.007|||analysis of covariance|adjusted for baseline score using mixed-model||||-0.007|-0.044|0.007
71886314|NCT01235962|143293167|SUPERIORITY||Mean Difference (24M DFS FU - UI)|-0.016||||0.13|TWO_SIDED|95.0|-0.036|0.005|||analysis of covariance|adjusted for baseline score using mixed-model||||0.005|-0.036|0.130
71886315|NCT01235962|143293167|SUPERIORITY||Mean Difference (36M DFS FU - UI)|0.007||||0.52|TWO_SIDED|95.0|-0.015|0.03|||analysis of covariance|adjusted for baseline score using mixed-model||||0.030|-0.015|0.520
71886316|NCT01235962|143293167|SUPERIORITY||Mean Difference (48M DFS FU - UI)|-0.014||||0.276|TWO_SIDED|95.0|-0.04|0.011|||analysis of covariance|adjusted for baseline score using mixed-model||||0.011|-0.040|0.276
71886317|NCT01235962|143293167|SUPERIORITY||Mean Difference (54M DFS FU - UI)|-0.007||||0.665|TWO_SIDED|95.0|-0.037|0.024|||analysis of covariance|adjusted for baseline score using mixed-model||||0.024|-0.037|0.665
71886318|NCT01331304|143293169|SUPERIORITY_OR_OTHER|||||||0.59||||||Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.|Mixed Models Analysis|||For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.||||0.59
71886319|NCT01331304|143293170|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up - to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.||||0.118
71886320|NCT01331304|143293171|SUPERIORITY|||||||0.11||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months||||0.11
71886321|NCT01331304|143293172|SUPERIORITY|||||||0.7||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months||||0.70
71886322|NCT04925752|143293238|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||Confidence Interval (CI) for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.182|0.010|<0.0001
71886323|NCT04925752|143293238|SUPERIORITY||Rate Ratio|0.043|||<|0.0001|TWO_SIDED|95.0|0.01|0.182||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.182|0.010|< 0.0001
71886324|NCT04925752|143293239|OTHER|Null Hypothesis 03: LEN - F/TDF\>= 0.8/100PY; Null hypothesis was to be rejected if HIV-1 incidence in LEN is not substantially greater than F/TDF (LEN is comparable to F/TDF).|Rate difference|-0.828|||<|0.0001|TWO_SIDED|95.0|-1.669|-0.255||p-value for rate difference (SC LEN minus F/TDF) is based on a hybrid approach.|Hybrid approach||Exact CI for rate difference versus F/TDF is based on a hybrid approach.|||-0.255|-1.669|<0.0001
71886325|NCT04925752|143293239|SUPERIORITY||Rate Ratio|0.111||||0.00245|TWO_SIDED|95.0|0.024|0.513||P-value for rate ratio versus F/TDF is from a Poisson model.|Poisson model||Confidence interval for rate ratio versus F/TDF is from a Poisson model.|Null Hypothesis 04: LEN vs F/TDF\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than F/TDF.||0.513|0.024|0.00245
71645650|NCT06078501|142807632|OTHER|||||||0.91|||||||Mann-Whitney U test|The a priori threshold for statistical significance was \<0.05.||||||0.91
71886326|NCT00866307|143293248|SUPERIORITY_OR_OTHER_LEGACY||Percentage|50.0|||||TWO_SIDED|90.0|35.6|64.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (\<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.||64.4|35.6|
71886327|NCT00866307|143293249|SUPERIORITY_OR_OTHER_LEGACY||Percentage|53.3|||||TWO_SIDED|90.0|38.7|67.4|||Agresti-Coull Confidence Interval|||Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (\<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.||67.4|38.7|
71886328|NCT01060059|143293274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.831|TWO_SIDED|95.0|0.62|1.46|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.46|0.62|0.831
71886329|NCT01060059|143293274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.554|TWO_SIDED|95.0|0.74|1.76||Baseline Medical conditions (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||1.76|0.74|0.554
71886330|NCT01060059|143293274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.714|TWO_SIDED|95.0|0.43|3.42||Baseline gastrointestinal symptoms (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.||3.42|0.43|0.714
71886331|NCT01060059|143293275|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.001|TWO_SIDED|95.0|0.6|0.78|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.78|0.60|<0.001
71886332|NCT01060059|143293276|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.055|TWO_SIDED|95.0|0.96|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.96|0.055
71886333|NCT01060059|143293277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||<|0.001|TWO_SIDED|95.0|0.95|0.99|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.99|0.95|<0.001
71886334|NCT01060059|143293278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.001|TWO_SIDED|95.0|1.15|1.23|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher BMI (1 kg/m\^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.23|1.15|<0.001
71886335|NCT01060059|143293279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.026|TWO_SIDED|95.0|1.0|1.05|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.05|1.00|0.026
71645651|NCT06078501|142807633|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
71645652|NCT06078501|142807634|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1.0
71645653|NCT06078501|142807635|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
71645654|NCT06078501|142807636|OTHER|||||||0.887||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||0.887
71645655|NCT06078501|142807638|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71645656|NCT06078501|142807639|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Mann-Whitney U test|||||||1.0
71645657|NCT06078501|142807640|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71645658|NCT04723693|142807663|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
71645659|NCT04723693|142807664|OTHER||||||||||||||||||This is a qualitative interview study and as such no statistical analysis was carried out.|||
71823998|NCT03643965|143151825|OTHER|Ratio of UACR at 9 months comparison of Nefecon to Placebo|Ratio of geometric LS means|0.69||||0.0005|TWO_SIDED|95.0|0.55|0.86|||MMRM model|||||0.86|0.55|0.0005
71823999|NCT03643965|143151826|OTHER|Time to 30% reduction in eGFR comparison Nefecon to Placebo|Hazard Ratio (HR)|0.45||||0.0028|TWO_SIDED|95.0|0.26|0.75|||Cox proportional hazards model|Cox proportional hazards model with individual patient censoring weighting.||||0.75|0.26|0.0028
71824000|NCT03643965|143151827|OTHER|Time to receiving rescue medication comparison Nefecon to Placebo|Hazard Ratio (HR)|0.68||||0.2647|TWO_SIDED|95.0|0.34|1.33|||Cox proportional hazards model|||||1.33|0.34|0.2647
71824001|NCT03643965|143151828|OTHER|Ratio of UPCR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.68|||MMRM model|||||0.68|0.51|<0.0001
71824002|NCT03643965|143151829|OTHER|Ratio of UACR compared to baseline averaged over time points between 12 and 24 months, Nefecon vs Placebo|Ratio of geometric LS means|0.54|||<|0.0001|TWO_SIDED|95.0|0.45|0.63|||MMRM model|||||0.63|0.45|<0.0001
71824003|NCT03643965|143151830|OTHER|Ratio of eGFR compared to baseline averaged over time points between 12 and 24 months, comparison Nefecon vs Placebo|Ratio of geometric LS means|1.11|||<|0.0001|TWO_SIDED|95.0|1.06|1.16|||robust regression|||||1.16|1.06|<0.0001
71824004|NCT03643965|143151831|OTHER|Proportion of patients without microhematuria, comparison Nefecon vs Placebo|Odds Ratio (OR)|2.5||||0.0001|TWO_SIDED|95.0|1.6|4.1|||Regression, Logistic|||||4.1|1.6|0.0001
71824005|NCT02820051|143151834|SUPERIORITY|||||||0.281||||||threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||The sample was calculated with alpha 0.05, beta 0.20, standard deviation of 7.3,8 minimum PtcCO2 difference to detect of 5 mmHg, loss to follow-up estimated 0.20, and two-tails. According to the above, the sample size was 42 patients per group.|We tested normal distribution with the Kolmogorov-Smirnov test. Data are shown as means and standard deviations for variables with normal distribution and as medians and interquartile ranges for non-normal variables. We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05. The analysis was performed using SPSS version 18.0 for Windows (SPSS Inc., Chicago, IL).|||0.281
71824006|NCT02820051|143151835|SUPERIORITY|We used the t-test, the Mann-Whitney U-test, ANOVA, or chi-square as indicated. We defined a statistically significant difference as a P value \< 0.05.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71824007|NCT02820051|143151836|SUPERIORITY|T test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71824008|NCT01222247|143151837|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.02|TWO_SIDED|95.0|0.66|0.97|||Chi-squared|||Analysis for Primary Outcome composite||0.97|0.66|0.02
71645660|NCT01410227|142807665|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis of the rate of subjects with a treatment success of \<= 0.65 (H0: p \<= 0.65) versus an alternative hypothesis of \> 0.65 (HA: p \> 0.65) was tested at the 5% one-sided level of significance. The proportion of subjects with treatment success under the alternative hypothesis was expected to be approximately 0.90. If 20 subjects were treated, the study provided 86% power to reject the null hypothesis.|Clopper-Pearson|100.0|||||TWO_SIDED|90.0|84.7|100.0|||Clopper-Pearson|||||100|84.7|
71645661|NCT00911274|142807760|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.41||||||90.0|82.77|103.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103.18|82.77|
71645662|NCT00911274|142807761|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.3||||||90.0|97.84|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.88|97.84|
71824009|NCT01222247|143151837|SUPERIORITY||Risk Ratio (RR)|0.77||||0.01|TWO_SIDED|95.0|0.63|0.95|||Chi-squared|||Analysis for CPAP or high-flow nasal cannula||0.95|0.63|0.01
71824010|NCT01222247|143151837|SUPERIORITY||Risk Ratio (RR)|0.77||||0.17|TWO_SIDED|95.0|0.53|1.12|||Chi-squared|||Analysis for Fraction of inspired oxygen||1.12|0.53|0.17
71824011|NCT01222247|143151837|SUPERIORITY||Risk Ratio (RR)|0.78||||0.26|TWO_SIDED|95.0|0.5|1.21|||Chi-squared|||Analysis for mechanical ventilation||1.21|0.50|0.26
71824012|NCT01222247|143151838|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.53|0.84|||Chi-squared|||||0.84|0.53|<0.001
71824013|NCT01222247|143151839|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.003|TWO_SIDED|95.0|0.66|0.92|||Chi-squared|||||0.92|0.66|0.003
71824014|NCT01222247|143151840|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.65|1.17|||Chi-squared|||||1.17|0.65|0.36
71824015|NCT01222247|143151841|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.68||||0.002|TWO_SIDED|95.0|0.53|0.87|||Chi-squared|||||0.87|0.53|0.002
71645663|NCT00911274|142807762|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|97.77|104.34|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.34|97.77|
71824016|NCT01222247|143151842|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.57|TWO_SIDED|95.0|0.55|1.39|||Chi-squared|||||1.39|0.55|0.57
71824017|NCT01222247|143151843|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.22||||0.04|TWO_SIDED|95.0|0.02|0.92|||Chi-squared|||||0.92|0.02|0.04
71824018|NCT01222247|143151844|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.45||||0.1|TWO_SIDED|95.0|0.17|1.19|||Chi-squared|||||1.19|0.17|0.10
71824019|NCT01222247|143151845|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.59||||0.03|TWO_SIDED|95.0|0.37|0.96|||Chi-squared|||||0.96|0.37|0.03
71824020|NCT01222247|143151846|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.004|TWO_SIDED|95.0|0.66|0.93|||Chi-squared|||||0.93|0.66|0.004
71824021|NCT01222247|143151847|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82||||0.74|TWO_SIDED|95.0|0.25|2.68|||Chi-squared|||||2.68|0.25|0.74
71824022|NCT01222247|143151848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Chi-squared|||||||0.50
71824023|NCT01222247|143151849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71824024|NCT01222247|143151850|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.13|TWO_SIDED|95.0|0.96|1.34|||Chi-squared|||||1.34|0.96|0.13
71824025|NCT01222247|143151851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Chi-squared|||||||0.10
71824026|NCT01222247|143151853|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.93|||Chi-squared|||||1.93|0.33|0.62
71824027|NCT01222247|143151855|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Chi-squared|||||1.18|0.66|0.40
71824028|NCT01222247|143151856|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.6|||<|0.001|TWO_SIDED|95.0|1.37|1.87|||Chi-squared|||||1.87|1.37|<0.001
71645664|NCT02412852|142807765|OTHER||||||||||||||||||\]The pharmacokinetics data are particularly sparse, and therefore substantial interpolations and imputations were required to produce an analyzable data set. Consequently, while not ideal, the Last Observation Carried Forward method was used for these data. There was a large amount of missing data which required imputation to determine results. The large amount of interpolations and imputations required for the pharmacokinetic analysis means that the pharmacokinetic results will need to be interpreted with caution. 3 X 3 Analysis of Variance used to compare Placebo to the two active groups. Missing data required imputation of available data.|||
71645665|NCT02412852|142807767|OTHER|ANOVA on only those subjects who completed testing.||||||0.05||||||The results were analyzed using an ANOVA with one between-subjects factor (Group: both placebo groups combined, 40 mg TV1001sr, and 80 mg TV1001sr); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).|ANOVA|The means of the three groups were further analyzed using a post hoc comparison procedure (the Scheffé test).||||||0.05
71645666|NCT02412852|142807768|OTHER|The composite conduction measure and the composite velocity measure were analyzed using an Analysis of Variance with one between-subjects factor (Group: combined placebo, 40 mg TV1001, and 80 mg TV1001); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).||||||0.15|||||||ANOVA|||||||.15
71645667|NCT02412852|142807769|OTHER|A 3 by 3 Analysis of Variance with one between-subjects factor (Combined placebo, 40 mg TV1001, or 80 mg TV1001) and one within-subjects factor (Visit 1, Visit 2, or Visit 3) was performed for HbA1c values.||||||0.36|||||||ANOVA|||||||.36
71645668|NCT02412852|142807770|OTHER|ANOVA to compare differences from baseline to completion of testing.||||||0.93|||||||ANOVA|||||||.93
71645669|NCT02960295|142807779|OTHER|There was no comparison group and no test of statistical significance.||||||||||||||||In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.|This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day|||
71645670|NCT02960295|142807780|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation (r)|||||||<0.05
71645671|NCT02960295|142807780|OTHER|This is an observational study|||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
71645672|NCT02960295|142807780|OTHER||||||<|0.05|||||||Pearson correlation coefficient (r)|||||||<0.05
71645673|NCT00841542|142807783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.19||||||90.0|94.2|102.34|||||Bioequivalence is established when 90% Confidence Interval falls withing 80 - 125|||102.34|94.20|
71645674|NCT00841542|142807784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.86||||||90.0|93.38|104.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.66|93.38|
71645675|NCT00841542|142807785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.22||||||90.0|93.87|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|93.87|
71645676|NCT01906372|142807789|SUPERIORITY_OR_OTHER||Frequency of achieving primary endpoint|0.7|||||TWO_SIDED|||||Open label single arm pilot trial without control group.||||||||
71645677|NCT01906372|142807790|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71645678|NCT01252953|142807793|OTHER|Time to first event|Rate Ratio|0.91||||0.004|TWO_SIDED|95.0|0.85|0.97|||Log Rank|||||0.97|0.85|0.004
71645679|NCT01252953|142807794|OTHER|Time to first event|Rate Ratio|0.93||||0.052|TWO_SIDED|95.0|0.86|1.0|||Log Rank|||||1|0.86|0.052
71645680|NCT01252953|142807795|OTHER|Time to first event|Rate Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.12||In accordance with the data analysis plan, if the outcome of a major atherosclerotic event did not reach significance, there was no hypothesis testing for presumed ischemic stroke, so no P value is given.||||||1.12|0.87|
71645681|NCT01252953|142807796|OTHER|Time to first event|Rate Ratio|0.93||||0.02|TWO_SIDED|95.0|0.88|0.99|||Log Rank|||||0.99|0.88|0.02
71645682|NCT00841659|142807799|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|99.96||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71645683|NCT00841659|142807800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|93.58||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71645684|NCT00841659|142807801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.29||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.|||||
71645685|NCT00073307|142807806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.146||95.0|0.74|1.04||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||1.04|0.74|0.146
71645686|NCT00073307|142807807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0287||95.0|0.62|0.97||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.||0.97|0.62|0.0287
71645687|NCT00073307|142807808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|1e-06||95.0|0.35|0.55|||Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01||0.55|0.35|<0.000001
71645688|NCT00073307|142807809|SUPERIORITY_OR_OTHER||Difference in response rates (CR+PR)|-2.1||||||95.0|-3.7|-0.6|||Cochran-Mantel-Haenszel|Adjustments for country and Motzer category|difference in response rates (CR+PR) = Placebo - Sorafenib|||-0.6|-3.7|
71645689|NCT00073307|142807810|SUPERIORITY_OR_OTHER|||||||0.98|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline FKSI-10 score and relative day of FKSI-10 completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.98
71645690|NCT00073307|142807811|SUPERIORITY_OR_OTHER|||||||0.83|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05||||0.83
71645691|NCT01438060|142807812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.802|TWO_SIDED|95.0|-1.15|1.49||Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.|ANOVA||Model based estimate.|Analysis at Baseline (Day 0)||1.49|-1.15|0.802
71645692|NCT01438060|142807812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.169|TWO_SIDED|95.0|-2.49|0.44||ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.|ANCOVA||Model based estimate|Analysis at Week 10||0.44|-2.49|0.169
71645693|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|0.79||||0.391|TWO_SIDED|95.0|0.47|1.35|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center||Analysis at Week 1||1.35|0.47|0.391
71645694|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|0.95||||0.766|TWO_SIDED|95.0|0.69|1.31|||Cochran-Mantel-Haenszel|CMH test with controlling for treatment and study center||Analysis at Week 2||1.31|0.69|0.766
71645695|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|1.01||||0.967|TWO_SIDED|95.0|0.76|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||1.32|0.76|0.967
71645696|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.505|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||1.19|0.71|0.505
71645697|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.59|TWO_SIDED|95.0|0.84|1.36||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||1.36|0.84|0.590
71645698|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.374|TWO_SIDED|95.0|0.89|1.37||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||1.37|0.89|0.374
71645699|NCT01438060|142807815|SUPERIORITY_OR_OTHER||Response ratio|1.15||||0.175|TWO_SIDED|95.0|0.94|1.41||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||1.41|0.94|0.175
71645700|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|0.88||||0.753|TWO_SIDED|95.0|0.41|1.92||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 1||1.92|0.41|0.753
71645701|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|0.9||||0.6|TWO_SIDED|95.0|0.62|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 2||1.32|0.62|0.600
71645702|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|0.93||||0.673|TWO_SIDED|95.0|0.65|1.31||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 3||1.31|0.65|0.673
71645703|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|0.83||||0.255|TWO_SIDED|95.0|0.6|1.14||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 4||1.14|0.60|0.255
71645704|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|0.99||||0.958|TWO_SIDED|95.0|0.74|1.33||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 6||1.33|0.74|0.958
71645705|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|0.92||||0.525|TWO_SIDED|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 8||1.19|0.71|0.525
71645706|NCT01438060|142807816|SUPERIORITY_OR_OTHER||Response ratio|1.07||||0.602|TWO_SIDED|95.0|0.82|1.4||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 10||1.40|0.82|0.602
71645707|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 1||||0.133
71645708|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 2||||0.282
71645709|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 3||||0.571
71645710|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 4||||0.895
71645711|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 6||||0.817
71645712|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 8||||0.795
71645713|NCT01438060|142807820|SUPERIORITY_OR_OTHER|||||||0.564||95.0||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 10||||0.564
71645714|NCT01438060|142807822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.733|TWO_SIDED|95.0|-1.08|1.54|||ANCOVA|||Analysis at baseline||1.54|-1.08|0.733
71645715|NCT01438060|142807822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.001|TWO_SIDED|95.0|-2.16|-0.54|||ANOVA|||Analysis at Week 10||-0.54|-2.16|0.001
71824029|NCT01222247|143151857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71824030|NCT01222247|143151858|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.4|TWO_SIDED|95.0|0.78|1.1|||Chi-squared|||||1.10|0.78|0.40
71824031|NCT01222247|143151859|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.4|||Chi-squared|||||1.40|0.95|0.15
71645716|NCT05604209|142807879|SUPERIORITY||Median log2 fold change|1.63|||<|0.001|TWO_SIDED|95.0|0.67|2.14|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within all vaccinees is zero.||2.14|0.67|<0.001
71645717|NCT05604209|142807879|SUPERIORITY||median log2 fold change|1.15||||0.008|TWO_SIDED|95.0|0.09|2.59|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||2.59|0.09|0.008
71645718|NCT05604209|142807879|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.93|4.59|||Wilcoxon (Mann-Whitney)|Within-am log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||4.59|0.93|0.008
71645719|NCT05604209|142807879|SUPERIORITY|||||||0.279|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.279
71645720|NCT05604209|142807880|SUPERIORITY||Median log2 fold change|1.66|||<|0.001|TWO_SIDED|95.0|1.09|2.33|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within all vaccinees is zero.||2.33|1.09|<0.001
71645721|NCT05604209|142807880|SUPERIORITY||Median log2 fold change|1.79||||0.008|TWO_SIDED|95.0|0.59|3.4|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C62-M4 vaccinated arm is zero.||3.40|0.59|0.008
71824032|NCT01222247|143151860|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.16||||0.24|TWO_SIDED|95.0|0.91|1.47|||Chi-squared|||||1.47|0.91|0.24
71824033|NCT01222247|143151861|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93||||0.09|TWO_SIDED|95.0|0.85|1.01|||Chi-squared|||Analysis for NICU stay of any duration||1.01|0.85|0.09
71824034|NCT01222247|143151861|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.98|||Chi-squared|||Analysis for duration greater than or equal to 3 days||0.98|0.80|0.03
71824035|NCT01222247|143151862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
71824036|NCT01222247|143151863|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.61||||0.08|TWO_SIDED|95.0|0.35|1.07|||Chi-squared|||Statistical analysis for chorioamnionitis||1.07|0.35|0.08
71824037|NCT01222247|143151863|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.96|TWO_SIDED|95.0|0.49|1.95|||Chi-squared|||Analysis for Postpartum Endometritis||1.95|0.49|0.96
71645722|NCT05604209|142807880|SUPERIORITY||Median log2 fold change|1.66||||0.008|TWO_SIDED|95.0|0.94|3.09|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 35 within the C1C62-M3M4 vaccinated arm is zero.||3.09|0.94|0.008
71645723|NCT05604209|142807880|SUPERIORITY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 35 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 35 are the same between the two vaccinated arms.||||0.878
71645724|NCT05604209|142807881|SUPERIORITY||Median log2 fold change|1.47|||<|0.001|TWO_SIDED|95.0|0.54|2.63|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within all vaccinees is zero.||2.63|0.54|<0.001
71645725|NCT05604209|142807881|SUPERIORITY||Median log2 fold change|1.09||||0.008|TWO_SIDED|95.0|0.39|3.61|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.61|0.39|0.008
71824038|NCT01222247|143151863|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.56|TWO_SIDED|95.0|0.93|1.15|||Chi-squared|||Statistical analysis for cesarean delivery||1.15|0.93|0.56
71824039|NCT01222247|143151864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Analysis for interval from randomization to delivery||||0.57
71824040|NCT01222247|143151865|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71824041|NCT04939428|143151872|SUPERIORITY||Confidence Interval|-2.0|||=|0.0848|TWO_SIDED|95.0|-5.0|0.9|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.9|-5|= 0.0848
71824042|NCT04939428|143151873|OTHER|Estimated differences and confidence intervals are provided.|Confidence Interval|-1.4|||||TWO_SIDED|95.0|-4.8|2.0|||Miettinen & Nurminen method|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||2.0|-4.8|
71824043|NCT04939428|143151874|OTHER|Estimated differences and confidence intervals are provided|Confidence Interval|0.3|||||TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen method.|||95% CIs (Tier 2 endpoints) was provided for between treatment differences in the percentage of participants with events; these analyses was performed using the Miettinen and Nurminen method.||1.0|-0.4|
71660943|NCT03118570|142835402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.430
71645726|NCT05604209|142807881|SUPERIORITY||Median log2 fold change|2.0||||0.016|TWO_SIDED|95.0|0.43|4.37|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-1 from baseline to day 42 within the C1C62-M3M4 vaccinated arm is zero.||4.37|0.43|0.016
71645727|NCT05604209|142807881|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-1 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-1 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.189
71702372|NCT01149785|142921817|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|328.31|||||TWO_SIDED|90.0|296.42|363.63||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||363.63|296.42|
71702373|NCT01149785|142921820|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|144.13|||||TWO_SIDED|90.0|126.42|164.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||164.33|126.42|
71702374|NCT01149785|142921823|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|519.65|||||TWO_SIDED|90.0|460.42|586.5||||||Natural log transformed AUClast of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||586.50|460.42|
71702375|NCT01149785|142921824|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|516.98|||||TWO_SIDED|90.0|457.88|583.72||||||Natural log transformed AUC (0-∞) of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||583.72|457.88|
71702376|NCT01149785|142921826|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|161.42|||||TWO_SIDED|90.0|143.09|182.09||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||182.09|143.09|
71702377|NCT01201863|142921830|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.07816|STANDARD_ERROR_OF_MEAN|1.3315||0.954|TWO_SIDED||||||comparison of slopes|Slopes by group and slope difference||To investigate a difference in change in outcome over time between treatment and control, a trend analysis was used in place of a profile analysis, where both control and treatment arms are described more parsimoniously i.e. by a slope (change in outcome over time) (Fitzmaurice 2011).||||0.9540
71702378|NCT00898807|142921843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.036|TWO_SIDED|95.0|-1.8|-0.06||P-value was not adjusted for multiple comparisons. All p-values are two-sided and p\<0.05 was the threshold for statistical significance.|Mixed Models Analysis|Mixed effects model w/ random intercept for patient, visit indicator, treatment by visit interactions and adjusted for baseline NBRS-A \& cognition.|Negative numbers favor citalopram group.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.||-0.06|-1.80|0.036
71702379|NCT00898807|142921844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.007|TWO_SIDED|95.0|1.23|3.69||All p-values are two-sided and p \<0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.|Proportional odds|estimated treatment effect from the proportional odds model|Positive numbers favors citalopram.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).||3.69|1.23|0.007
71702380|NCT04919161|142921847|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due sample size differences and pairwise nature of the data, a Kruskal-Wallis was conducted.||Null hypothesis for this analysis is that there will be no differences between pre-scores and post-scores across the different treatment arms. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
71702381|NCT04919161|142921847|SUPERIORITY||||||=|0.0025||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0025
71824044|NCT04939428|143151875|SUPERIORITY||Confidence Interval|-3.2|||=|0.0205|TWO_SIDED|95.0|-6.3|-0.1|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||-0.1|-6.3|= 0.0205
71824045|NCT04939428|143151876|OTHER|Adjusted differences and the corresponding confidence intervals.|Confidence Interval|-2.2|||||TWO_SIDED|95.0|-5.4|1.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||1.0|-5.4|
71645728|NCT05604209|142807882|SUPERIORITY||Median log2 fold change|1.78|||<|0.001|TWO_SIDED|95.0|0.81|2.51|||Wilcoxon (Mann-Whitney)|Within-group log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within all vaccinees is zero.||2.51|0.81|<0.001
71645729|NCT05604209|142807882|SUPERIORITY||Median log2 fold change|1.57||||0.008|TWO_SIDED|95.0|0.63|3.89|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C62-M4 vaccinated arm is zero.||3.89|0.63|0.008
71645730|NCT05604209|142807882|SUPERIORITY||Median log2 fold change|1.78||||0.016|TWO_SIDED|95.0|0.7|3.79|||Wilcoxon (Mann-Whitney)|Within-arm log2 fold changes were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median log2-fold change in magnitude of T-cell response to Mosaic-2 from baseline to day 42 within the C162-M3M4 vaccinated arm is zero.||3.79|0.70|0.016
71645731|NCT05604209|142807882|SUPERIORITY|||||||0.955|||||||Wilcoxon (Mann-Whitney)|Between-arm comparisons in log2 fold changes were statistically assessed using a two-sided exact Wilcoxon rank-sum test.||The contrast is the magnitude of the T-cell response to Mosaic-2 from baseline to day 42 in C62-M4 versus C1C62-M3M4.The null hypothesis is that he distributions of the T-cell response to Mosaic-2 from pre-vaccination to day 42 are the same between the two vaccinated arms.||||0.955
71645732|NCT05604209|142807883|SUPERIORITY||Median Difference (Net)|2.0||||0.125|TWO_SIDED|95.0|-1.0|4.0|||Wilcoxon (Mann-Whitney)|Within-group changes in breadth from baseline to day 56 were statistically assessed using a two-sided exact Wilcoxon signed rank test.||The null hypothesis is that the median change in breadth of T-cell response to HIV-1 subpools from baseline to day 56 within all vaccinees is zero.||4|-1|0.125
71645733|NCT00112437|142807884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.5|||<=|0.001|TWO_SIDED|95.0|2.54|4.45||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||4.45|2.54|<=0.001
71645734|NCT00112437|142807884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.78|||<=|0.001|TWO_SIDED|95.0|1.82|3.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||3.73|1.82|<=0.001
71645735|NCT00112437|142807884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.63||||0.003|TWO_SIDED|95.0|0.68|2.59||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||2.59|0.68|0.003
71645736|NCT00112437|142807884|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.49||||0.343|TWO_SIDED|95.0|-1.44|0.46||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.||0.46|-1.44|0.343
71645737|NCT00112437|142807885|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.67|||<=|0.001|TWO_SIDED|95.0|4.32|7.02||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||7.02|4.32|<=0.001
71645738|NCT00112437|142807885|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.45|||<=|0.001|TWO_SIDED|95.0|3.15|5.76||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||5.76|3.15|<=0.001
71645739|NCT00112437|142807885|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.39|||<=|0.001|TWO_SIDED|95.0|2.06|4.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||4.73|2.06|<=0.001
71645740|NCT00112437|142807885|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.84||||0.218||95.0|-2.19|0.51||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.||0.51|-2.19|0.218
71645741|NCT00112437|142807886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.49|||<=|0.001|TWO_SIDED|95.0|1.62|3.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||3.35|1.62|<=0.001
71645742|NCT00112437|142807886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.06|||<=|0.001|TWO_SIDED|95.0|1.2|2.93||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.93|1.20|<=0.001
71645743|NCT00112437|142807886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.67|||<=|0.001|TWO_SIDED|95.0|0.8|2.53||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||2.53|0.80|<=0.001
71645744|NCT00112437|142807886|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.75||||0.135|TWO_SIDED|95.0|-1.61|0.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.||0.11|-1.61|0.135
71645745|NCT00112437|142807887|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.66|||<=|0.001|TWO_SIDED|95.0|1.71|3.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||3.61|1.71|<=0.001
71645746|NCT00112437|142807887|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.89|||<=|0.001|TWO_SIDED|95.0|0.93|2.84||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||2.84|0.93|<=0.001
71645747|NCT00112437|142807887|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.87||||0.095|TWO_SIDED|95.0|-0.09|1.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||1.82|-0.09|0.095
71645748|NCT00112437|142807887|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.19|||||TWO_SIDED|95.0|-1.14|0.75|||ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.||0.75|-1.14|
71660944|NCT03118570|142835402|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.091||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.091
71645749|NCT00112437|142807888|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.94|||<=|0.001|TWO_SIDED|95.0|1.64|4.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||4.24|1.64|<=0.001
71645750|NCT00112437|142807888|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.65|||<=|0.001|TWO_SIDED|95.0|1.35|3.94||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.94|1.35|<=0.001
71645751|NCT00112437|142807888|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.38|||<=|0.001|TWO_SIDED|95.0|1.08|3.69||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||3.69|1.08|<=0.001
71645752|NCT00112437|142807888|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.29||||0.731|TWO_SIDED|95.0|-1.58|1.0||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.||1.00|-1.58|0.731
71645753|NCT00112437|142807889|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.29||||0.112|TWO_SIDED|95.0|-0.77|1.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||1.35|-0.77|0.112
71645754|NCT00112437|142807889|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.09|||||TWO_SIDED|95.0|-1.13|0.95||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.95|-1.13|
71645755|NCT00112437|142807889|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.63|||||TWO_SIDED|95.0|-1.69|0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||0.42|-1.69|
71645756|NCT00112437|142807889|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47|||||TWO_SIDED|95.0|-2.53|-0.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.||-0.42|-2.53|
71660945|NCT03118570|142835403|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.527||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.527
71824046|NCT04939428|143151877|OTHER|Adjusted differences and the corresponding confidence intervals|Confidence Interval|-3.0|||||TWO_SIDED|95.0|-6.9|0.8||||||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||0.8|-6.9|
71824047|NCT04939428|143151878|OTHER|Adjusted differences and the corresponding confidence intervals.|Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-22.7|2.0|||Miettinen & Nurminen method|||Adjusted differences and the corresponding confidence intervals are based on Miettinen \& Nurminen method stratified by age and household size.||2.0|-22.7|
71702382|NCT04919161|142921847|SUPERIORITY||||||=|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||=0.0001
71824048|NCT05302791|143151888|SUPERIORITY|||||||0.609|||||||ANOVA|time x condition ANOVA||||||.609
71824049|NCT05302791|143151889|SUPERIORITY|||||||0.858|||||||ANOVA|time x condition anova||||||.858
71824050|NCT05302791|143151890|SUPERIORITY|||||||0.633|||||||ANOVA|||||||.633
71824051|NCT05302791|143151891|SUPERIORITY|||||||0.076|||||||ANOVA|||||||.076
71824052|NCT05302791|143151892|SUPERIORITY|||||||0.151|||||||ANOVA|||||||.151
71824053|NCT05302791|143151893|SUPERIORITY|||||||0.385|||||||ANOVA|||||||.385
71824054|NCT05302791|143151894|SUPERIORITY|||||||0.665|||||||ANOVA|||||||.665
71824055|NCT05302791|143151895|SUPERIORITY|||||||0.078|||||||ANOVA|||||||.078
71824056|NCT05302791|143151896|SUPERIORITY|||||||0.773|||||||ANOVA|||||||.773
71824057|NCT05302791|143151897|SUPERIORITY|||||||0.118|||||||ANOVA|||||||.118
71824058|NCT05302791|143151898|SUPERIORITY||||||<|0.001|||||||ANOVA|Time x condition ANOVA||||||<0.001
71824059|NCT05302791|143151899|SUPERIORITY||||||<|0.001|||||||ANOVA|time x condition anova||||||<0.001
71824060|NCT02696785|143151909|SUPERIORITY||Odds Ratio (OR)|2.73||||0.005|TWO_SIDED|95.0|1.35|5.52|||Regression, Logistic|||Overall Work Impairment Score||5.52|1.35|0.005
71824061|NCT02696785|143151909|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.2|9.03|||Regression, Logistic|||Overall Work Impairment Score.||9.03|2.20|<0.001
71824062|NCT02696785|143151909|SUPERIORITY||Odds Ratio (OR)|5.09|||<|0.001|TWO_SIDED|95.0|2.52|10.28|||Regression, Logistic|||Overall Work Impairment Score.||10.28|2.52|<0.001
71824063|NCT02696785|143151909|SUPERIORITY||LSMean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-13.2|-0.7|||ANCOVA|||Percentage of Activity Impairment||-0.7|-13.2|<0.001
71824064|NCT02696785|143151909|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-15.5|-3.0|||ANCOVA|||Percentage of Activity Impairment||-3.0|-15.5|<0.001
71824065|NCT02696785|143151909|SUPERIORITY||LSMean Difference|-8.9|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-15.2|-2.5|||ANCOVA|||Percentage of Activity Impairment||-2.5|-15.2|<0.001
71824066|NCT02696785|143151910|SUPERIORITY||Odds Ratio (OR)|2.3||||0.007|TWO_SIDED|95.0|1.25|4.23|||Regression, Logistic|||||4.23|1.25|0.007
71824067|NCT02696785|143151910|SUPERIORITY||Odds Ratio (OR)|2.78||||0.001|TWO_SIDED|95.0|1.48|5.24|||Regression, Logistic|||||5.24|1.48|0.001
71824068|NCT02696785|143151910|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|1.79|6.41|||Regression, Logistic|||||6.41|1.79|<0.001
71824069|NCT02696785|143151911|SUPERIORITY||LSMean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|95.0|-1.11|-0.57|||Mixed Models Analysis|||||-0.57|-1.11|<0.001
71824070|NCT02696785|143151911|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-1.25|-0.7|||Mixed Models Analysis|||||-0.70|-1.25|<0.001
71824071|NCT02696785|143151911|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.18|-0.63|||Mixed Models Analysis|||||-0.63|-1.18|<0.001
71824072|NCT02696785|143151912|SUPERIORITY||Odds Ratio (OR)|2.53||||0.012|TWO_SIDED|95.0|1.23|5.21|||Regression, Logistic|||||5.21|1.23|0.012
71824073|NCT02696785|143151912|SUPERIORITY||Odds Ratio (OR)|3.74|||<|0.001|TWO_SIDED|95.0|1.82|7.7|||Regression, Logistic|||||7.70|1.82|<0.001
71824074|NCT02696785|143151912|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.91|7.98|||Regression, Logistic|||||7.98|1.91|<0.001
71824075|NCT02696785|143151913|SUPERIORITY||LSMean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.299||0.001|TWO_SIDED|95.0|-1.56|-0.39|||Mixed Models Analysis|||||-0.39|-1.56|0.001
71824076|NCT02696785|143151913|SUPERIORITY||LSMean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.83|-0.62|||Mixed Models Analysis|||||-0.62|-1.83|<0.001
71824077|NCT02696785|143151913|SUPERIORITY||LSMean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.86|-0.67|||Mixed Models Analysis|||||-0.67|-1.86|<0.001
71824078|NCT02696785|143151914|SUPERIORITY||LSMean Difference|7.62||||0.009|TWO_SIDED|95.0|1.67|34.68|||Regression, Logistic|||||34.68|1.67|0.009
71824079|NCT02696785|143151914|SUPERIORITY||Odds Ratio (OR)|8.03||||0.007|TWO_SIDED|95.0|1.75|36.83|||Regression, Logistic|||||36.83|1.75|0.007
71824080|NCT02696785|143151914|SUPERIORITY||Odds Ratio (OR)|5.13||||0.041|TWO_SIDED|95.0|1.07|24.49|||Regression, Logistic|||||24.49|1.07|0.041
71824081|NCT02696785|143151915|SUPERIORITY||LSMean Difference|-2.78|STANDARD_ERROR_OF_MEAN|0.447|<|0.001|TWO_SIDED|95.0|-3.7|-1.9|||ANCOVA|||||-1.9|-3.7|<0.001
71824082|NCT02696785|143151915|SUPERIORITY||LSMean Difference|-2.62|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
71824083|NCT02696785|143151915|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.452|<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||ANCOVA|||||-1.5|-3.3|<0.001
71824084|NCT02696785|143151916|SUPERIORITY||LSMean Difference|3.2574|STANDARD_ERROR_OF_MEAN|1.0437||0.002|TWO_SIDED|95.0|1.2041|5.3106|||Mixed Models Analysis|||PCS||5.3106|1.2041|0.002
71824085|NCT02696785|143151916|SUPERIORITY||LSMean Difference|4.052|STANDARD_ERROR_OF_MEAN|1.072|<|0.001|TWO_SIDED|95.0|1.9432|6.1608|||Mixed Models Analysis|||PCS||6.1608|1.9432|<0.001
71824086|NCT02696785|143151916|SUPERIORITY||LSMean Difference|4.3254|STANDARD_ERROR_OF_MEAN|1.0641|<|0.001|TWO_SIDED|95.0|2.2321|6.4186|||Mixed Models Analysis|||PCS||6.4186|2.2321|<0.001
71824087|NCT02696785|143151916|SUPERIORITY||LSMean Difference|0.4321|STANDARD_ERROR_OF_MEAN|1.1718||0.713|TWO_SIDED|95.0|-1.8732|2.7373|||Mixed Models Analysis|||MCS||2.7373|-1.8732|0.713
71824088|NCT02696785|143151916|SUPERIORITY||LSMean Difference|0.6273|STANDARD_ERROR_OF_MEAN|1.2028||0.602|TWO_SIDED|95.0|-1.7387|2.9934|||Mixed Models Analysis|||MCS||2.9934|-1.7387|0.602
71824089|NCT02696785|143151916|SUPERIORITY||LSMean Difference|0.4467|STANDARD_ERROR_OF_MEAN|1.1978||0.709|TWO_SIDED|95.0|-1.9097|2.803|||Mixed Models Analysis|||MCS||2.8030|-1.9097|0.709
71824090|NCT02696785|143151917|SUPERIORITY||LSMean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.416||0.012|TWO_SIDED|95.0|-1.87|-0.23|||Mixed Models Analysis|||||-0.23|-1.87|0.012
71824091|NCT02696785|143151917|SUPERIORITY||LSMean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.428||0.01|TWO_SIDED|95.0|-1.95|-0.27|||Mixed Models Analysis|||||-0.27|-1.95|0.010
71645757|NCT00112437|142807890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.23|||<=|0.001|TWO_SIDED|95.0|0.22|2.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.24|0.22|<=0.001
71645758|NCT00112437|142807890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.1||||0.005|TWO_SIDED|95.0|0.09|2.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||2.11|0.09|0.005
71645759|NCT00112437|142807890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.27||||0.63|TWO_SIDED|95.0|-0.74|1.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||1.29|-0.74|0.630
71645760|NCT00112437|142807890|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27|||||TWO_SIDED|95.0|-2.28|-0.27||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.||-0.27|-2.28|
71645761|NCT00112437|142807891|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-57.86|||<=|0.001|TWO_SIDED|95.0|-72.33|-43.38||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-43.38|-72.33|<=0.001
71645762|NCT00112437|142807891|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-45.92|||<=|0.001|TWO_SIDED|95.0|-60.93|-30.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-30.91|-60.93|<=0.001
71645763|NCT00112437|142807891|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-31.84|||<=|0.001|TWO_SIDED|95.0|-48.11|-15.58||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||-15.58|-48.11|<=0.001
71660946|NCT03118570|142835403|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.738||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.738
71660947|NCT03118570|142835403|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.465||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.465
71824092|NCT02696785|143151917|SUPERIORITY||LSMean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.423|<|0.001|TWO_SIDED|95.0|-2.32|-0.66|||Mixed Models Analysis|||||-0.66|-2.32|<0.001
71824093|NCT02696785|143151918|SUPERIORITY||LSMean Difference|-8.628|STANDARD_ERROR_OF_MEAN|2.6724||0.001|TWO_SIDED|95.0|-13.885|-3.371|||Mixed Models Analysis|||||-3.371|-13.885|0.001
71824094|NCT02696785|143151918|SUPERIORITY||LSMean Difference|-6.635|STANDARD_ERROR_OF_MEAN|2.7438||0.016|TWO_SIDED|95.0|-12.033|-1.238|||Mixed Models Analysis|||||-1.238|-12.033|0.016
71645764|NCT00112437|142807891|SUPERIORITY_OR_OTHER||Difference in Least Square Means|11.17||||0.249|TWO_SIDED|95.0|-0.94|43.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.||43.24|-0.94|0.249
71645765|NCT00112437|142807892|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-56.33|||<=|0.001||95.0|-75.86|-36.81||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-36.81|-75.86|<=0.001
71645766|NCT00112437|142807892|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.57|||<=|0.001||95.0|-56.63|-14.51||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Square Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||-14.51|-56.63|<=0.001
71645767|NCT00112437|142807892|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.66||||0.08||95.0|-44.54|1.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||1.23|-44.54|0.080
71645768|NCT00112437|142807892|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||||TWO_SIDED|95.0|-8.48|47.88||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.||47.88|-8.48|
71645769|NCT00112437|142807893|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.28||||0.004|TWO_SIDED|95.0|-35.82|-0.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||-0.74|-35.82|0.004
71645770|NCT00112437|142807893|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.26||||0.344|TWO_SIDED|95.0|-19.9|17.39||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.39|-19.90|0.344
71660948|NCT03118570|142835403|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.068||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.068
71824095|NCT02696785|143151918|SUPERIORITY||LSMean Difference|-7.991|STANDARD_ERROR_OF_MEAN|2.7248||0.004|TWO_SIDED|95.0|-13.351|-2.631|||Mixed Models Analysis|||||-2.631|-13.351|0.004
71824096|NCT02696785|143151919|SUPERIORITY||LSMean Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.1143||0.001|TWO_SIDED|95.0|-0.592|-0.142|||Mixed Models Analysis|||||-0.142|-0.592|0.001
71824097|NCT02696785|143151919|SUPERIORITY||LSMean Difference|-0.422|STANDARD_ERROR_OF_MEAN|0.1184|<|0.001|TWO_SIDED|95.0|-0.655|-0.189|||Mixed Models Analysis|||||-0.189|-0.655|<0.001
71645771|NCT00112437|142807893|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.33|||||TWO_SIDED|95.0|-20.55|17.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||17.89|-20.55|
71645772|NCT00112437|142807893|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|28.15|||||TWO_SIDED|95.0|5.84|50.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.||50.46|5.84|
71660949|NCT03118570|142835403|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.328||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.328
71660950|NCT03118570|142835403|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.277||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.277
71702383|NCT04919161|142921847|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
71702384|NCT04919161|142921847|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison would be that there would be no significant difference between post-scores of the two treatment groups.||||>0.9999
71702385|NCT04919161|142921848|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: ScoreChange=(PostTest) - (PreTest). These changes in score were then compared.|||||=|0.3045||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|t-test, 2 sided|||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.3045
71702386|NCT04919161|142921849|SUPERIORITY|Prior to analysis, the score change or difference between post-test and pre-test were calculated for each participant as: PercentScoreChange = (\[(PostTest)-(PreTest)\]/\[PreTest\]) x 100%|||||=|3152||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Two-Tailed Welch t test|Due to unequal standard deviation, a two-tailed Welch's t test was used.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=3152
71702387|NCT04919161|142921850|SUPERIORITY||||||=|0.9568||||||Prior to analysis, the score change between post assessment and pre-assessment was calculated. The threshold for significance was p\<0.05.|t-test, 2 sided|An unpaired T-test was used. Normality and F-test for Variances were conducted and found to be normal.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||=0.9568
71702388|NCT04919161|142921851|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to the pairwise nature and abnormal distribution of the pre- and post-scores, a Kruskal Wallis test was completed.||Null Hypothesis, there would be no difference between the pre-score and post-score of each treatment group. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
71702389|NCT04919161|142921851|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
71702390|NCT04919161|142921851|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||<0.0001
71702391|NCT04919161|142921851|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
71824098|NCT02696785|143151919|SUPERIORITY||LSMean Difference|-0.329|STANDARD_ERROR_OF_MEAN|0.1167||0.005|TWO_SIDED|95.0|-0.558|-0.099|||Mixed Models Analysis|||||-0.099|-0.558|0.005
71645773|NCT00112437|142807894|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-15.57|||<=|0.001|TWO_SIDED|95.0|-26.11|-5.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||-5.04|-26.11|<=0.001
71645774|NCT00112437|142807894|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.43||||0.645|TWO_SIDED|95.0|-6.02|16.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||16.89|-6.02|0.645
71645775|NCT00112437|142807894|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|11.73|||||TWO_SIDED|95.0|-0.47|23.92||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||23.92|-0.47|
71645776|NCT00112437|142807894|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|44.85|||||TWO_SIDED|95.0|30.55|59.16||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.||59.16|30.55|
71645777|NCT00112437|142807895|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-35.74|||<=|0.001|TWO_SIDED|95.0|-52.14|-19.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||-19.33|-52.14|<=0.001
71645778|NCT00112437|142807895|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.68||||0.161|TWO_SIDED|95.0|-20.58|17.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.23|-20.58|0.161
71645779|NCT00112437|142807895|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.58|||||TWO_SIDED|95.0|-20.99|17.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||17.82|-20.99|
71660951|NCT03118570|142835404|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.092||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.092
71702392|NCT04919161|142921851|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis. The reported P-value is adjusted for multiple comparisons.|Dunn's Multiple Comparison Test|||Null hypothesis for this comparison is that there would be no significant difference in the pre-score measurements between groups.||||>0.9999
71762723|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|2.53||||0.0059|TWO_SIDED|90.0|1.02|4.03|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.03|1.02|0.0059
71886336|NCT01060059|143293280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.77|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||0.77|0.18|0.007
71645780|NCT00112437|142807895|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|46.9|||||TWO_SIDED|95.0|22.35|71.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.||71.44|22.35|
71645781|NCT00112437|142807896|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.1|||<=|0.001|TWO_SIDED|95.0|2.77|5.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||5.42|2.77|<=0.001
71645782|NCT00112437|142807896|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.48|||<=|0.001|TWO_SIDED|95.0|2.2|4.77||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.77|2.20|<=0.001
71645783|NCT00112437|142807896|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.75|||<=|0.001|TWO_SIDED|95.0|1.43|4.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||4.07|1.43|<=0.001
71645784|NCT00112437|142807896|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.51||||0.536|TWO_SIDED|95.0|-1.84|0.83||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.||0.83|-1.84|0.536
71645785|NCT00112437|142807897|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.69|||<=|0.001|TWO_SIDED|95.0|3.25|6.12||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||6.12|3.25|<=0.001
71645786|NCT00112437|142807897|SUPERIORITY_OR_OTHER||Difference in Least Square Means|3.57|||<=|0.001|TWO_SIDED|95.0|2.18|4.97||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.97|2.18|<=0.001
71645787|NCT00112437|142807897|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.82|||<=|0.001|TWO_SIDED|95.0|1.39|4.25||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||4.25|1.39|<=0.001
71645788|NCT00112437|142807897|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.41||||0.585|TWO_SIDED|95.0|-1.85|1.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.||1.04|-1.85|0.585
71645789|NCT00112437|142807898|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.09|||<=|0.001|TWO_SIDED|95.0|3.18|7.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||7.01|3.18|<=0.001
71645790|NCT00112437|142807898|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.56|||<=|0.001|TWO_SIDED|95.0|2.7|6.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.42|2.70|<=0.001
71645791|NCT00112437|142807898|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|4.43|||<=|0.001|TWO_SIDED|95.0|2.52|6.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||6.33|2.52|<=0.001
71645792|NCT00112437|142807898|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.04||||0.981|TWO_SIDED|95.0|-1.97|1.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.||1.89|-1.97|0.981
71645793|NCT00112437|142807899|SUPERIORITY_OR_OTHER||Difference in Least square means|1.73|||<=|0.001||95.0|0.46|3.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||3.01|0.46|<=0.001
71645794|NCT00112437|142807899|SUPERIORITY_OR_OTHER||Difference in Least square means|1.11||||0.028||95.0|-0.12|2.34||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||2.34|-0.12|0.028
71645795|NCT00112437|142807899|SUPERIORITY_OR_OTHER||Difference in Least square means|0.2||||0.804||95.0|-1.1|1.49||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||1.49|-1.10|0.804
71660952|NCT03118570|142835404|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.31||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.310
71645796|NCT00112437|142807899|SUPERIORITY_OR_OTHER||Difference in Least square means|-1.15|||||TWO_SIDED|95.0|-2.46|0.15||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.||0.15|-2.46|
71645797|NCT00112437|142807900|SUPERIORITY_OR_OTHER||Difference in Least square means|2.9|||<=|0.001|TWO_SIDED|95.0|1.34|4.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||4.46|1.34|<=0.001
71645798|NCT00112437|142807900|SUPERIORITY_OR_OTHER||Difference in Least square means|2.09|||<=|0.001||95.0|0.59|3.6||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.60|0.59|<=0.001
71645799|NCT00112437|142807900|SUPERIORITY_OR_OTHER||Difference in Least square means|1.53||||0.094||95.0|-0.01|3.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||3.07|-0.01|0.094
71645800|NCT00112437|142807900|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.95||||||95.0|-4.5|-1.4||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.||-1.40|-4.50|
71645801|NCT00112437|142807901|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-47.21|||<=|0.001||95.0|-64.51|-29.9||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-29.90|-64.51|<=0.001
71660953|NCT03118570|142835404|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.304||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.304
71660954|NCT03118570|142835404|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.155||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.155
71824099|NCT02696785|143151920|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.211||0.003|TWO_SIDED|95.0|0.22|1.05|||Mixed Models Analysis|||||1.05|0.22|0.003
71824100|NCT02696785|143151920|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.219||0.051|TWO_SIDED|95.0|0.0|0.86|||Mixed Models Analysis|||||0.86|-0.00|0.051
71824101|NCT02696785|143151920|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.215||0.005|TWO_SIDED|95.0|0.18|1.03|||Mixed Models Analysis|||||1.03|0.18|0.005
71824102|NCT02696785|143151921|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.321||0.039|TWO_SIDED|95.0|-1.3|-0.03|||Mixed Models Analysis|||||-0.03|-1.30|0.039
71824103|NCT02696785|143151921|SUPERIORITY||LSMean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.33||0.057|TWO_SIDED|95.0|-1.28|0.02|||Mixed Models Analysis|||||0.02|-1.28|0.057
71824104|NCT02696785|143151921|SUPERIORITY||LSMean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.327||0.042|TWO_SIDED|95.0|-1.31|-0.03|||Mixed Models Analysis|||||-0.03|-1.31|0.042
71824105|NCT02696785|143151922|SUPERIORITY||LSMean Difference|-5.13|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|-6.7|-3.5|||ANCOVA|||||-3.5|-6.7|<0.001
71645802|NCT00112437|142807901|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-33.67|||<=|0.001||95.0|-51.44|-15.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-15.91|-51.44|<=0.001
71645803|NCT00112437|142807901|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-35.94|||<=|0.001||95.0|-54.15|-17.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||-17.74|-54.15|<=0.001
71645804|NCT00112437|142807901|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|17.51||||0.101|TWO_SIDED|95.0|-6.78|41.8||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.||41.80|-6.78|0.101
71645805|NCT00112437|142807902|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-63.34|||<=|0.001||95.0|-88.32|-38.36||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-38.36|-88.32|<=0.001
71645806|NCT00112437|142807902|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-39.29|||<=|0.001|TWO_SIDED|95.0|-65.4|-13.18||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||-13.18|-65.40|<=0.001
71645807|NCT00112437|142807902|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-23.98||||0.124|TWO_SIDED|95.0|-53.04|5.09||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||5.09|-53.04|0.124
71645808|NCT00112437|142807902|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.18|||||TWO_SIDED|95.0|-12.38|56.73|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.||56.73|-12.38|
71702393|NCT04919161|142921852|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Kruskal-Wallis|Due to missing measurements and the pairwise nature of the pre- and post-scores, a Kruskal Wallis test was completed.||Null hypothesis is that there are no differences between groups. Prior to hypothesis testing, datasets were tested for normality using a Shapiro-Wilk test to inform if parametric or non-parametric testing was required.||||<0.0001
71702394|NCT04919161|142921852|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
71645809|NCT00112437|142807903|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.71||||0.015||95.0|-36.03|2.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||2.61|-36.03|0.015
71645810|NCT00112437|142807903|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-8.51||||0.246||95.0|-27.31|10.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||10.29|-27.31|0.246
71645811|NCT00112437|142807903|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-1.79||||||95.0|-22.66|19.08|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||19.08|-22.66|
71645812|NCT00112437|142807903|SUPERIORITY_OR_OTHER||Difference in Least Square Means|21.74||||||95.0|-1.32|44.81|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.||44.81|-1.32|
71645813|NCT00112437|142807904|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-16.64||||0.002||95.0|-28.84|-4.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||-4.44|-28.84|0.002
71645814|NCT00112437|142807904|SUPERIORITY_OR_OTHER||Difference in Least Square Means|7.24||||0.852||95.0|-5.73|20.21||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||20.21|-5.73|0.852
71645815|NCT00112437|142807904|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.39||||||95.0|-13.69|12.92|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||12.92|-13.69|
71645816|NCT00112437|142807904|SUPERIORITY_OR_OTHER||Difference in Least Square Means|36.79||||||95.0|21.19|52.38|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.||52.38|21.19|
71702395|NCT04919161|142921852|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||<0.0001
71702396|NCT04919161|142921852|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
71702397|NCT04919161|142921852|SUPERIORITY||||||>|0.9999||||||The a priori threshold for statistical significance was p\<0.05. The p-value reported above was the calculated and resultant P-value for this analysis.|Dunn's Multiple Comparison Test|||||||>0.9999
71762724|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|2.5||||0.0063|TWO_SIDED|90.0|1.0|4.01|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||4.01|1.00|0.0063
71824106|NCT02696785|143151922|SUPERIORITY||LSMean Difference|-4.89|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-6.5|-3.3|||ANCOVA|||||-3.3|-6.5|<0.001
71824107|NCT02696785|143151922|SUPERIORITY||LSMean Difference|-5.17|STANDARD_ERROR_OF_MEAN|0.816|<|0.001|TWO_SIDED|95.0|-6.8|-3.6|||ANCOVA|||||-3.6|-6.8|<0.001
71824108|NCT02696785|143151923|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.317|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||||0.5|-1.4|0.317
71645817|NCT00112437|142807905|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-21.49||||0.011|TWO_SIDED|95.0|-39.55|-3.43||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||-3.43|-39.55|0.011
71645818|NCT00112437|142807905|SUPERIORITY_OR_OTHER||Difference in Least square means|13.31||||0.618||95.0|-7.1|33.71||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least square means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||33.71|-7.10|0.618
71645819|NCT00112437|142807905|SUPERIORITY_OR_OTHER||Difference in Least square means|7.77|||||TWO_SIDED|95.0|-13.46|29.01|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||29.01|-13.46|
71645820|NCT00112437|142807905|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.23|||||TWO_SIDED|95.0|23.86|74.59|||ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.||74.59|23.86|
71645821|NCT00112437|142807906|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.45|||||TWO_SIDED|95.0|3.38|9.53||||||In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.||9.53|3.38|
71645822|NCT00112437|142807907|SUPERIORITY_OR_OTHER||Difference in Least Square Means|6.31|||||TWO_SIDED|95.0|3.44|9.17||||||||9.17|3.44|
71645823|NCT00112437|142807908|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.71|||||TWO_SIDED|95.0|-0.16|5.57||||||||5.57|-0.16|
71645824|NCT00112437|142807909|SUPERIORITY_OR_OTHER||Difference in Least Square Means|8.13|||||TWO_SIDED|95.0|3.8|12.46||||||||12.46|3.80|
71645825|NCT00112437|142807910|SUPERIORITY_OR_OTHER||Difference in Least Square Means|1.46|||||TWO_SIDED|95.0|-1.54|4.46||||||||4.46|-1.54|
71645826|NCT00112437|142807911|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.47|||||TWO_SIDED|95.0|-0.93|5.88||||||||5.88|-0.93|
71824109|NCT02696785|143151923|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.683|TWO_SIDED|95.0|-1.1|0.8|||Mixed Models Analysis|||||0.8|-1.1|0.683
71824110|NCT02696785|143151923|SUPERIORITY||LSMean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.5|TWO_SIDED|95.0|-1.3|0.6|||Mixed Models Analysis|||||0.6|-1.3|0.500
71824111|NCT02696785|143151924|SUPERIORITY||LSMean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.154|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||||0.3|-1.9|0.154
71824112|NCT02696785|143151924|SUPERIORITY||LSMean Difference|0.255|STANDARD_ERROR_OF_MEAN|0.56||-0.6|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||||0.5|-1.8|-0.6
71824113|NCT02696785|143151924|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.58||0.398|TWO_SIDED|95.0|-1.6|0.7|||Mixed Models Analysis|||||0.7|-1.6|0.398
71645827|NCT00112437|142807912|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-78.06|||||TWO_SIDED|95.0|-119.2|-36.92||||||||-36.92|-119.20|
71645828|NCT00112437|142807913|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-34.25|||||TWO_SIDED|95.0|-78.7|10.2||||||||10.20|-78.70|
71645829|NCT00112437|142807914|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-39.25|||||TWO_SIDED|95.0|-87.17|8.68||||||||8.68|-87.17|
71645830|NCT00112437|142807915|SUPERIORITY_OR_OTHER||Difference in Least Square Means|16.59|||||TWO_SIDED|95.0|-5.67|38.85||||||||38.85|-5.67|
71645831|NCT00112437|142807916|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-5.43|||||TWO_SIDED|95.0|-42.04|31.18||||||||31.18|-42.04|
71645832|NCT00112437|142807917|SUPERIORITY_OR_OTHER||Difference in Least Square Means|49.1|||||TWO_SIDED|95.0|13.37|84.83||||||||84.83|13.37|
71645833|NCT00112437|142807918|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|209.44|||||TWO_SIDED|95.0|127.14|291.73||||||||291.73|127.14|
71645834|NCT03703258|142807923|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.26||0.6|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.60
71645835|NCT03703258|142807923|SUPERIORITY||Cohen's D|0.36|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71645836|NCT03703258|142807924|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.27||0.94|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.94
71645837|NCT03703258|142807924|SUPERIORITY||Cohen's D|-0.01|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71645838|NCT03703258|142807925|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.38|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.38
71645839|NCT03703258|142807925|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71645840|NCT03703258|142807926|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED||||||Mixed Models Analysis||Condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|||||.04
71645841|NCT03703258|142807926|SUPERIORITY||Cohen's D|-0.7|||||TWO_SIDED||||||||Between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|||||
71645842|NCT03703258|142807927|SUPERIORITY||Slope|-1.23|STANDARD_ERROR_OF_MEAN|1.88||0.51|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.51
71645843|NCT03703258|142807927|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
71645844|NCT03703258|142807927|SUPERIORITY||Cohen's D|-0.1|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71645845|NCT03703258|142807927|SUPERIORITY||Cohen's D|0.02|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71645846|NCT03703258|142807928|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.04
71645847|NCT03703258|142807928|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.34
71645848|NCT03703258|142807928|SUPERIORITY||Cohen's D|0.92|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to post-intervention only||||
71645849|NCT03703258|142807928|SUPERIORITY||Cohen's D|0.68|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Positive values favor intervention and negative values favor control.|Baseline to 3 months||||
71702398|NCT04919161|142921853|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p\<0.05.|Kruskal-Wallis|Due to the missing measurement and the pairwise nature of the perturbation levels between participants, a Kruskal Wallis test was completed.||Null hypothesis is there are no differences between groups. Prior to hypothesis testing, normality testing was conducted using a Shapiro-Wild test to inform if parametric or non-parametric testing was required.||||<0.0001
71824114|NCT02696785|143151925|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.76||0.783|TWO_SIDED|95.0|-1.7|1.3|||Mixed Models Analysis|||||1.3|-1.7|0.783
71645850|NCT03703258|142807929|SUPERIORITY||Slope|-2.46|STANDARD_ERROR_OF_MEAN|1.63||0.13|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.13
71645851|NCT03703258|142807929|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.64||0.24|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.24
71645852|NCT03703258|142807929|SUPERIORITY||Cohen's D|-0.41|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71645853|NCT03703258|142807929|SUPERIORITY||Cohen's D|-0.23|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71645854|NCT03703258|142807930|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.25||0.85|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.85
71645855|NCT03703258|142807930|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.25||0.96|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.96
71645856|NCT03703258|142807930|SUPERIORITY||Cohen's D|-0.15|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71645857|NCT03703258|142807930|SUPERIORITY||Cohen's D|0.003|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71645858|NCT03703258|142807931|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.75|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.75
71645859|NCT03703258|142807931|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.64|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.64
71645860|NCT03703258|142807931|SUPERIORITY||Cohen's D|-0.12|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71645861|NCT03703258|142807931|SUPERIORITY||Cohen's D|-0.16|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71645862|NCT03703258|142807932|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.35||0.86|TWO_SIDED||||||Mixed Models Analysis||Post-intervention condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to post-intervention only||||.86
71645863|NCT03703258|142807932|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.36||0.55|TWO_SIDED||||||Mixed Models Analysis||3 month condition x time interaction coefficient from mixed-effect model using negative binomial distribution. Intervention = 1 and control = 0.|Baseline to 3 months||||.55
71645864|NCT03703258|142807932|SUPERIORITY||Cohen's D|-0.04|||||TWO_SIDED||||||||Post-intervention between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to post-intervention only||||
71645865|NCT03703258|142807932|SUPERIORITY||Cohen's D|-0.39|||||TWO_SIDED||||||||3 month between-group Cohen's d; calculated as within-group d(intervention) - within group d(control). Standardized using the standard deviation of the change scores. Negative values favor intervention and positive values favor control.|Baseline to 3 months||||
71645866|NCT01229150|142807995|SUPERIORITY_OR_OTHER|||||||0.24|||||||Log Rank|||||||0.24
71645867|NCT01229150|142807995|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||0.75
71645868|NCT01229150|142807999|SUPERIORITY_OR_OTHER|||||||0.51|||||||Log Rank|||||||0.51
71645869|NCT01229150|142807999|SUPERIORITY_OR_OTHER|||||||0.81|||||||Log Rank|||||||0.81
71645870|NCT01229150|142808001|SUPERIORITY_OR_OTHER||||||<|0.0007||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.|Wilcoxon matched-pairs signed rank test|||||||<0.0007
71645871|NCT01229150|142808001|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||||||<0.0001
71702399|NCT04919161|142921853|SUPERIORITY||||||>|0.9999||||||Reported p-value is adjusted for multiple comparisons. The a priori threshold for statistical significance was established as p\<0.05.|Dunn's Multiple Comparison Test|||Null hypothesis for any comparisons would be that there is no significant mean perturbation level between sessions.|The p-value reported above was the result for 15 comparisons of the recorded perturbation levels in sessions: 1 vs 2, 2 vs 3, 3 vs 4, 3 vs 5, 3 vs 6, 4 vs 5, 4 vs 6, 4 vs 7, 4 vs 8, 5 vs 6, 5 vs 7, 5 vs 8, 6 vs 7, 6 vs 8, and 7 vs 8.|||>0.9999
71702400|NCT04919161|142921853|SUPERIORITY||||||=|0.0629|||||||Dunn's Multiple Comparison Test|||||||=0.0629
71645872|NCT01229150|142808001|SUPERIORITY_OR_OTHER|||||||0.0209||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||4 patients in this group; statistically underpowered.||||0.0209
71645873|NCT00902538|142808034|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||ANCOVA|||||||0.1187
71645874|NCT00902538|142808034|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71645875|NCT00902538|142808035|SUPERIORITY_OR_OTHER|||||||0.0425||95.0|||||ANCOVA|||||||0.0425
71645876|NCT00902538|142808035|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71645877|NCT00902538|142808036|SUPERIORITY_OR_OTHER|||||||0.1939||95.0|||||Cochran-Mantel-Haenszel|||||||0.1939
71645878|NCT00902538|142808036|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71645879|NCT00902538|142808037|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|||||||0.0009
71645880|NCT00902538|142808037|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71645881|NCT00902538|142808038|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71645882|NCT00902538|142808038|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71645883|NCT00902538|142808039|SUPERIORITY_OR_OTHER|||||||0.1611||95.0|||||ANCOVA|||||||0.1611
71645884|NCT00902538|142808040|SUPERIORITY_OR_OTHER|||||||0.0451||95.0|||||ANCOVA|||||||0.0451
71645885|NCT00902538|142808041|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||ANCOVA|||||||0.0412
71645886|NCT00902538|142808042|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||ANCOVA|||||||0.0253
71645887|NCT00902538|142808043|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||||||0.0063
71702401|NCT04919161|142921853|SUPERIORITY||||||=|0.0069|||||||Dunn's Multiple Comparison Test|||||||=0.0069
71702402|NCT04919161|142921853|SUPERIORITY||||||=|0.0003|||||||Dunn's Multiple Comparison Test|||||||=0.0003
71702403|NCT04919161|142921853|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
71702404|NCT04919161|142921853|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
71702405|NCT04919161|142921853|SUPERIORITY||||||<|0.0001|||||||Dunn's Multiple Comparison Test|||||||<0.0001
71702406|NCT04919161|142921853|SUPERIORITY||||||=|0.6497|||||||Dunn's Multiple Comparison Test|||||||=0.6497
71702407|NCT04919161|142921853|SUPERIORITY||||||=|0.0743|||||||Dunn's Multiple Comparison Test|||||||=0.0743
71702408|NCT04919161|142921853|SUPERIORITY||||||=|0.0198|||||||Dunn's Multiple Comparison Test|||||||=0.0198
71702409|NCT04919161|142921853|SUPERIORITY||||||=|0.0017|||||||Dunn's Multiple Comparison Test|||||||=0.0017
71702410|NCT04919161|142921853|SUPERIORITY||||||=|0.0006|||||||Dunn's Multiple Comparison Test|||||||=0.0006
71702411|NCT04919161|142921853|SUPERIORITY||||||=|0.5297|||||||Dunn's Multiple Comparison Test|||||||=0.5297
71702412|NCT04919161|142921853|SUPERIORITY||||||=|0.2595|||||||Dunn's Multiple Comparison Test|||||||=0.2595
71824115|NCT02696785|143151925|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.78||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.550
71645888|NCT00849797|142808050|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|90.86||||||90.0|85.47|96.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.60|85.47|
71645889|NCT00849797|142808051|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|96.59|100.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.66|96.59|
71645890|NCT00849797|142808052|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.74||||||90.0|96.71|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100.80|96.71|
71645891|NCT00849797|142808053|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.5||||||90.0|95.66|100.48|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||100.48|95.66|
71645892|NCT00849797|142808054|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.29||||||90.0|98.96|101.64|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.|||101.64|98.96|
71645893|NCT00849797|142808055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.08||||||90.0|98.91|101.27|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.|||101.27|98.91|
71645894|NCT00926887|142808063|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71645895|NCT00926887|142808066|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|t=-2.711; df=102; p\<0.01||||||<0.01
71645896|NCT00926887|142808070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|df=102, t=-3.44||||||<0.001
71645897|NCT02302716|142808083|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week HbA1c level for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|-0.04||||0.693|TWO_SIDED|95.0|-0.22|0.15|||Mixed Models Analysis|||||0.15|-0.22|0.693
71645898|NCT02997176|142808098|OTHER|Bioequivalence|Percent Ratio of Geometric Means|142.19|||||TWO_SIDED|90.0|79.92|252.98||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||252.98|79.92|
71645899|NCT02997176|142808098|OTHER|Bioequivalence|Percent Ratio of Geometric Means|110.54|||||TWO_SIDED|90.0|54.58|223.85||||||AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.||223.85|54.58|
71645900|NCT02997176|142808099|OTHER|Bioequivalence|Percent Ratio of Geometric Means|109.76|||||TWO_SIDED|90.0|70.93|169.84||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||169.84|70.93|
71645901|NCT02997176|142808099|OTHER|Bioequivalence|Percent Ratio of Geometric Means|131.67|||||TWO_SIDED|90.0|77.14|224.74||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||224.74|77.14|
71645902|NCT02997176|142808100|OTHER|Bioequivalence|Percent Ratio of Geometric Means|149.39|||||TWO_SIDED|90.0|91.49|243.93||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||243.93|91.49|
71645903|NCT02997176|142808100|OTHER|Bioequivalence|Percent Ratio of Geometric Means|111.04|||||TWO_SIDED|90.0|60.91|202.43||||||AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||202.43|60.91|
71645904|NCT02997176|142808101|OTHER|Bioequivalence|Percent Ratio of Geometric Means|115.32|||||TWO_SIDED|90.0|77.95|170.6||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.6|77.95|
71702413|NCT04919161|142921854|OTHER|This is a descriptive analysis.|Odds Ratio (OR)|2.6|||=|0.3898|TWO_SIDED|95.0|0.4671|15.3||Threshold for statistical significance was p\<0.05|Fisher Exact|||Null hypothesis was that there would be no difference in the proportion of males and females between treatment arms.||15.300|0.4671|=0.3898
71824116|NCT02696785|143151925|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.77||0.091|TWO_SIDED|95.0|-2.8|0.2|||Mixed Models Analysis|||||0.2|-2.8|0.091
71645905|NCT02997176|142808101|OTHER|Bioequivalence|Percent Ratio of Geometric Means|132.26|||||TWO_SIDED|90.0|81.87|213.67||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||213.67|81.87|
71645906|NCT02997176|142808102|OTHER|Bioequivalence|Percent Ratio of Geometric Means|124.4|||||TWO_SIDED|90.0|85.19|181.66||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||181.66|85.19|
71645907|NCT02997176|142808102|OTHER|Bioequivalence|Percent Ratio of Geometric Means|113.42|||||TWO_SIDED|90.0|73.9|174.07||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||174.07|73.90|
71702414|NCT00712920|142921855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03||95.0|-1.7|-0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.10|-1.70|0.03
71702415|NCT00712920|142921855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.08||95.0|-1.5|0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.1|-1.5|0.08
71824117|NCT02696785|143151927|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.027|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.027
71824118|NCT02696785|143151927|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.33||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
71645908|NCT02997176|142808102|OTHER|Bioequivalence|Percent Ratio of Geometric Means|95.68|||||TWO_SIDED|90.0|67.9|134.83||||||AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.83|67.90|
71645909|NCT02997176|142808103|OTHER|Bioequivalence|Percent Ratio of Geometric Means|99.31|||||TWO_SIDED|90.0|57.74|170.8||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||170.80|57.74|
71645910|NCT02997176|142808103|OTHER|Bioequivalence|Percent Ratio of Geometric Means|96.45|||||TWO_SIDED|90.0|52.22|178.14||||||Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||178.14|52.22|
71645911|NCT02997176|142808103|OTHER|Bioequivalence|Percent Ratio of Geometric Means|64.05|||||TWO_SIDED|90.0|39.65|103.46||||||Cmax was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||103.46|39.65|
71645912|NCT02997176|142808106|OTHER|Bioequivalence|Percent Ratio of Geometric Means|118.47|||||TWO_SIDED|90.0|83.81|167.47||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||167.47|83.81|
71645913|NCT02997176|142808106|OTHER|Bioequivalence|Percent Ratio of Geometric Means|108.36|||||TWO_SIDED|90.0|73.25|160.3||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||160.30|73.25|
71645914|NCT02997176|142808106|OTHER|Bioequivalence|Percent Ratio of Geometric Means|117.84|||||TWO_SIDED|90.0|85.29|162.83||||||AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.||162.83|85.29|
71645915|NCT02997176|142808107|OTHER|Bioequivalence|Percent Ratio of Geometric Means|94.58|||||TWO_SIDED|90.0|56.74|157.64||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||157.64|56.74|
71645916|NCT02997176|142808107|OTHER|Bioequivalence|Percent Ratio of Geometric Means|92.15|||||TWO_SIDED|90.0|51.69|164.26||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||164.26|51.69|
71645917|NCT02997176|142808107|OTHER|Bioequivalence|Percent Ratio of Geometric Means|84.42|||||TWO_SIDED|90.0|53.14|134.1||||||Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.||134.10|53.14|
71645918|NCT02727192|142808142|SUPERIORITY||Mean Difference (Net)|-0.6||||0.52|TWO_SIDED|95.0|-2.6|1.3||A two-sided significance level of 5% was considered to indicate statistical significance.|Regression, Linear|||||1.3|-2.6|0.520
71645919|NCT02727192|142808143|SUPERIORITY||Mean Difference (Net)|-0.9||||0.44|TWO_SIDED|95.0|-3.3|1.5|||Regression, Linear|||||1.5|-3.3|0.440
71645920|NCT02727192|142808144|SUPERIORITY||Mean Difference (Net)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.9|||Regression, Linear|||||0.9|-2.1|0.410
71645921|NCT02727192|142808145|SUPERIORITY||Difference in Percentage of Participants|-9.3||||0.33|TWO_SIDED||||||Chi-squared|||||||0.33
71645922|NCT02727192|142808148|SUPERIORITY||Mean Difference (Net)|2.8||||0.058|TWO_SIDED|95.0|-0.1|5.8|||Regression, Linear|||Mental Component Summary score||5.8|-0.1|0.058
71824119|NCT02696785|143151927|SUPERIORITY||LSMean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.035|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||||-0.0|-1.3|0.035
71645923|NCT02727192|142808148|SUPERIORITY||Mean Difference (Net)|-2.1||||0.16|TWO_SIDED|95.0|-5.1|0.8|||Regression, Linear|||Physical Component Summary score||0.8|-5.1|0.160
71645924|NCT02727192|142808149|SUPERIORITY||Mean Difference (Net)|-0.9||||0.11|TWO_SIDED|95.0|-2.0|0.2|||Regression, Linear|||||0.2|-2.0|0.110
71645925|NCT02727192|142808151|SUPERIORITY||Mean Difference (Net)|0.1||||0.85|TWO_SIDED|95.0|-0.5|0.6|||Regression, Linear|||||0.6|-0.5|0.850
71645926|NCT02727192|142808153|SUPERIORITY||Median Difference (Net)|0.3||||0.65|TWO_SIDED|95.0|-1.0|1.6|||Regression, Linear|||||1.6|-1.0|0.650
71645927|NCT02727192|142808154|SUPERIORITY||Mean Difference (Net)|2.6||||0.006|TWO_SIDED|95.0|0.8|4.5|||Regression, Linear|||||4.5|0.8|0.006
71645928|NCT02727192|142808155|SUPERIORITY||Median Difference (Net)|-31.4||||0.389|TWO_SIDED|95.0|-103.4|40.7|||Regression, Linear|||||40.7|-103.4|0.389
71645929|NCT02727192|142808158|SUPERIORITY||Mean Difference (Net)|0.1||||0.697|TWO_SIDED|95.0|-0.3|0.5|||Regression, Logistic|||||0.5|-0.3|0.697
71645930|NCT00928057|142808160|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.506||||||The threshold for statistical significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% \|∆ Fru\|), with 95 % confidence intervals."||||0.506
71824120|NCT02696785|143151928|SUPERIORITY||LSMean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.3|0.0|||Mixed Models Analysis|||||-0.0|-2.3|0.041
71645931|NCT00928057|142808160|NON_INFERIORITY_OR_EQUIVALENCE|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.878||||||The threshold for significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % \|∆ Fru\|, with 95% confidence intervals."||||0.878
71645932|NCT00928057|142808165|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance, or alpha, is 0.05.|t-test, 1 sided|||The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.||||0.019
71645933|NCT00928057|142808165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||As described for the 4 vs. 5mm statistical analysis.||||<0.001
71645934|NCT03428750|142808189|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.006
71645935|NCT03428750|142808190|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645936|NCT03428750|142808191|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.001
71645937|NCT03428750|142808192|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645938|NCT03428750|142808193|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645939|NCT03428750|142808194|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645940|NCT03428750|142808195|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645941|NCT03428750|142808196|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645942|NCT03428750|142808197|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71645943|NCT01919112|142808213|OTHER|Regression models using interaction terms will used to assess for heterogeneity of intervention effects across the novel radiological variable corticobulbar tract (CBT)-lesion load, a combined measure of lesion size and location. For purposes of the analysis, the CBT-lesion load was dichotomized into 2 groups based on the median CBT-lesion load volume.||||||0.116||||||Interaction p-values will be considered statistically significant at the 0.15 level of significance given the relatively low power for tests of interaction to detect a true interaction.|2-way analysis of variance with interact|The tDCS intervention was the main variable of interest, PAS score the main outcome and CBT-lesion load was the interaction term used.||The aim for this analysis was to assess for effect modification of the trial intervention across the novel radiological variable corticobulbar tract-lesion load.||||0.116
71645944|NCT02554877|142808214|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.91|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.34|-0.48||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.48|-1.34|<0.0001
71645945|NCT02554877|142808214|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.16|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.59|-0.73||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-0.73|-1.59|<0.0001
71645946|NCT02554877|142808214|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.17|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.6|-0.74||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-0.74|-1.60|<0.0001
71645947|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
71645948|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.26|-0.52|<0.0001
71645949|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.57|-0.3||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.||-0.30|-0.57|<0.0001
71824121|NCT02696785|143151928|SUPERIORITY||LSMean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.59||0.125|TWO_SIDED|95.0|-2.1|0.3|||Mixed Models Analysis|||||0.3|-2.1|0.125
71824122|NCT02696785|143151928|SUPERIORITY||LSMean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.013|TWO_SIDED|95.0|-2.6|-0.3|||Mixed Models Analysis|||||-0.3|-2.6|0.013
71645950|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.42|-0.76|<0.0001
71645951|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.8|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.80|<0.0001
71645952|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.||-0.46|-0.79|<0.0001
71660955|NCT03118570|142835404|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.392||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.392
71824123|NCT02696785|143151929|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|3.082||0.989|TWO_SIDED|95.0|-6.03|6.12|||Mixed Models Analysis|||||6.12|-6.03|0.989
71824124|NCT02696785|143151929|SUPERIORITY||LSMean Difference|2.5|STANDARD_ERROR_OF_MEAN|3.146||0.429|TWO_SIDED|95.0|-3.71|8.7|||Mixed Models Analysis|||||8.70|-3.71|0.429
71645953|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.93|-0.49||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 8.||-0.49|-0.93|<0.0001
71645954|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.96|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.17|-0.74||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.74|-1.17|<0.0001
71645955|NCT02554877|142808215|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.76||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.||-0.76|-1.20|<0.0001
71645956|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-37.83|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-47.96|-27.7||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-27.70|-47.96|<0.0001
71645957|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-44.85|STANDARD_ERROR_OF_MEAN|5.13|<|0.0001|TWO_SIDED|95.0|-54.98|-34.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-34.72|-54.98|<0.0001
71645958|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-48.59|STANDARD_ERROR_OF_MEAN|5.18|<|0.0001|TWO_SIDED|95.0|-58.81|-38.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||-38.37|-58.81|<0.0001
71645959|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-30.63|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-42.52|-18.74||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-18.74|-42.52|<0.0001
71645960|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-39.24|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-51.13|-27.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-27.35|-51.13|<0.0001
71645961|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-38.3|STANDARD_ERROR_OF_MEAN|6.04|<|0.0001|TWO_SIDED|95.0|-50.22|-26.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-26.38|-50.22|<0.0001
71645962|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.47|STANDARD_ERROR_OF_MEAN|6.29||0.0023|TWO_SIDED|95.0|-31.88|-7.05||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-7.05|-31.88|0.0023
71645963|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.98|STANDARD_ERROR_OF_MEAN|6.23|<|0.0001|TWO_SIDED|95.0|-49.27|-24.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-24.69|-49.27|<0.0001
71645964|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.14|STANDARD_ERROR_OF_MEAN|6.29|<|0.0001|TWO_SIDED|95.0|-47.55|-22.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||-22.72|-47.55|<0.0001
71702416|NCT00712920|142921856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6419|STANDARD_DEVIATION|0.3924||0.102||95.0|-1.41|0.13|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.13|-1.41|0.102
71702417|NCT00712920|142921856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7925|STANDARD_DEVIATION|0.3935||0.044||95.0|-1.56|-0.02|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.02|-1.56|0.044
71702418|NCT00712920|142921857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4394|STANDARD_DEVIATION|0.3631||0.226||95.0|-1.15|0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||0.27|-1.15|0.226
71702419|NCT00712920|142921857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1252|STANDARD_DEVIATION|0.3649||0.002||95.0|-1.84|-0.41|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28||-0.41|-1.84|0.002
71702420|NCT00712920|142921858|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.292
71702421|NCT00712920|142921858|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||||||0.040
71702422|NCT02489773|142921860|OTHER|Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)|pearson correlation coefficient|0.6342|||||TWO_SIDED|||||||||||||
71824125|NCT02696785|143151929|SUPERIORITY||LSMean Difference|-5.47|STANDARD_ERROR_OF_MEAN|3.27||0.096|TWO_SIDED|95.0|-11.92|0.98|||Mixed Models Analysis|||||0.98|-11.92|0.096
71645965|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-19.77|STANDARD_ERROR_OF_MEAN|6.1||0.0014|TWO_SIDED|95.0|-31.81|-7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||-7.73|-31.81|0.0014
71645966|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-35.26|STANDARD_ERROR_OF_MEAN|6.03|<|0.0001|TWO_SIDED|95.0|-47.17|-23.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-23.35|-47.17|<0.0001
71645967|NCT02554877|142808216|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-36.44|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001|TWO_SIDED|95.0|-48.43|-24.46||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12||-24.46|-48.43|<0.0001
71645968|NCT02554877|142808217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.057||||0.0059|TWO_SIDED|95.0|1.68|21.82||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||21.82|1.68|0.0059
71645969|NCT02554877|142808217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.927||||0.0008|TWO_SIDED|95.0|2.49|31.96||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||31.96|2.49|0.0008
71645970|NCT02554877|142808217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.116|||<|0.0001|TWO_SIDED|95.0|4.34|52.67||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<7%)||52.67|4.34|<0.0001
71645971|NCT02554877|142808217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.1532|TWO_SIDED|95.0|0.64|17.47||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||17.47|0.64|0.1532
71645972|NCT02554877|142808217|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.198||||0.0826|TWO_SIDED|95.0|0.83|21.22||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||21.22|0.83|0.0826
71645973|NCT02554877|142808217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.588||||0.0272|TWO_SIDED|95.0|1.21|25.73||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C\<6.5%)||25.73|1.21|0.0272
71645974|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.03|STANDARD_ERROR_OF_MEAN|3.4||0.7618|TWO_SIDED|90.0|-6.66|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.59|-6.66|0.7618
71645975|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.65|STANDARD_ERROR_OF_MEAN|3.39||0.8489|TWO_SIDED|90.0|-6.25|4.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||4.96|-6.25|0.8489
71645976|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.47|STANDARD_ERROR_OF_MEAN|3.42||0.4699|TWO_SIDED|90.0|-3.17|8.12||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.12|-3.17|0.4699
71645977|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.22|STANDARD_ERROR_OF_MEAN|3.27||0.4979|TWO_SIDED|90.0|-7.63|3.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.19|-7.63|0.4979
71645978|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-3.45|STANDARD_ERROR_OF_MEAN|3.27||0.2927|TWO_SIDED|90.0|-8.85|1.95||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.95|-8.85|0.2927
71645979|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.83|STANDARD_ERROR_OF_MEAN|3.28||0.143|TWO_SIDED|90.0|-10.26|0.6||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||0.60|-10.26|0.1430
71645980|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.25|STANDARD_ERROR_OF_MEAN|3.73||0.7373|TWO_SIDED|90.0|-7.42|4.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.92|-7.42|0.7373
71660956|NCT03118570|142835404|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.464||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.464
71824126|NCT02696785|143151933|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.76||0.166|TWO_SIDED|95.0|-2.6|0.4|||Mixed Models Analysis|||||0.4|-2.6|0.166
71645981|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.46|STANDARD_ERROR_OF_MEAN|3.7||0.5075|TWO_SIDED|90.0|-8.57|3.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.66|-8.57|0.5075
71645982|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.81|STANDARD_ERROR_OF_MEAN|3.74||0.6295|TWO_SIDED|90.0|-7.99|4.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.37|-7.99|0.6295
71645983|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.15|STANDARD_ERROR_OF_MEAN|3.95||0.4266|TWO_SIDED|90.0|-3.39|9.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.69|-3.39|0.4266
71645984|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.96|STANDARD_ERROR_OF_MEAN|3.89||0.2038|TWO_SIDED|90.0|-1.47|11.4||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.40|-1.47|0.2038
71645985|NCT02554877|142808222|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.29|STANDARD_ERROR_OF_MEAN|3.92||0.5592|TWO_SIDED|90.0|-4.19|8.78||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.78|-4.19|0.5592
71645986|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.09|||||TWO_SIDED|90.0|-5.86|16.05||||||Placebo was the reference and each of the active doses was the test for Week 2.||16.05|-5.86|
71645987|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.86|||||TWO_SIDED|90.0|-9.76|15.48||||||Placebo was the reference and each of the active doses was the test for Week 2.||15.48|-9.76|
71645988|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.13|||||TWO_SIDED|90.0|3.91|30.34||||||Placebo was the reference and each of the active doses was the test for Week 2.||30.34|3.91|
71645989|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.71|||||TWO_SIDED|90.0|-10.8|16.22||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.22|-10.80|
71645990|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.92|||||TWO_SIDED|90.0|-10.61|16.45||||||Placebo was the reference and each of the active doses was the test for Week 4.||16.45|-10.61|
71824127|NCT02696785|143151933|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.73||0.011|TWO_SIDED|95.0|-3.4|-0.4|||Mixed Models Analysis|||||-0.4|-3.4|0.011
71645991|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.57|||||TWO_SIDED|90.0|-15.08|9.94||||||Placebo was the reference and each of the active doses was the test for Week 4.||9.94|-15.08|
71645992|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.63|||||TWO_SIDED|90.0|-16.29|13.03||||||Placebo was the reference and each of the active doses was the test for Week 8.||13.03|-16.29|
71645993|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.59|||||TWO_SIDED|90.0|-20.4|11.22||||||Placebo was the reference and each of the active doses was the test for Week 8.||11.22|-20.40|
71645994|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.75|||||TWO_SIDED|90.0|-13.66|19.16||||||Placebo was the reference and each of the active doses was the test for Week 8.||19.16|-13.66|
71645995|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.86|||||TWO_SIDED|90.0|-3.3|19.02||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.02|-3.30|
71645996|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.13|||||TWO_SIDED|90.0|-16.13|13.87||||||Placebo was the reference and each of the active doses was the test for Week 12.||13.87|-16.13|
71645997|NCT02554877|142808223|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.99|||||TWO_SIDED|90.0|-7.07|19.04||||||Placebo was the reference and each of the active doses was the test for Week 12.||19.04|-7.07|
71645998|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.04|STANDARD_ERROR_OF_MEAN|2.52||0.68|TWO_SIDED|90.0|-3.12|5.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.20|-3.12|0.6800
71645999|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.515|TWO_SIDED|90.0|-2.52|5.8||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||5.80|-2.52|0.5150
71824128|NCT02696785|143151933|SUPERIORITY||LSMean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.77||0.182|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||||0.5|-2.6|0.182
71824129|NCT02696785|143151934|SUPERIORITY||LSMean Difference|-10.07|STANDARD_ERROR_OF_MEAN|1.588|<|0.001|TWO_SIDED|95.0|-13.2|-6.9|||ANCOVA|||||-6.9|-13.2|<0.001
71824130|NCT02696785|143151934|SUPERIORITY||LSMean Difference|-9.51|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-12.6|-6.4|||ANCOVA|||||-6.4|-12.6|<0.001
71824131|NCT02696785|143151934|SUPERIORITY||LSMean Difference|-8.08|STANDARD_ERROR_OF_MEAN|1.603|<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||ANCOVA|||||-4.9|-11.2|<0.001
71702423|NCT02489773|142921860|OTHER|Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.|Difference with PG 0.8|-0.1658|||>|0.9999|TWO_SIDED|95.0|-0.2204|-0.1113|||t-test, 2 sided|||||-0.1113|-0.2204|>0.9999
71646000|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.66|STANDARD_ERROR_OF_MEAN|2.53||0.0676|TWO_SIDED|90.0|0.47|8.85||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.85|0.47|0.0676
71646001|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.62|STANDARD_ERROR_OF_MEAN|2.48||0.8021|TWO_SIDED|90.0|-4.73|3.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.48|-4.73|0.8021
71646002|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.95|STANDARD_ERROR_OF_MEAN|2.49||0.4346|TWO_SIDED|90.0|-6.06|2.16||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.16|-6.06|0.4346
71646003|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.03|STANDARD_ERROR_OF_MEAN|2.49||0.4173|TWO_SIDED|90.0|-6.15|2.09||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.09|-6.15|0.4173
71646004|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-0.98|STANDARD_ERROR_OF_MEAN|2.56||0.7036|TWO_SIDED|90.0|-5.21|3.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||3.26|-5.21|0.7036
71646005|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.64|STANDARD_ERROR_OF_MEAN|2.54||0.2993|TWO_SIDED|90.0|-6.84|1.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.56|-6.84|0.2993
71646006|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.08|STANDARD_ERROR_OF_MEAN|2.57||0.9751|TWO_SIDED|90.0|-4.16|4.32||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||4.32|-4.16|0.9751
71646007|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.23|STANDARD_ERROR_OF_MEAN|2.86||0.1408|TWO_SIDED|90.0|-0.5|8.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.96|-0.50|0.1408
71702424|NCT02489773|142921861|OTHER|The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficients|0.249|||<|0.0001|TWO_SIDED|95.0|0.13|0.364|||t-test, 2 sided|||||0.364|0.130|<0.0001
71824132|NCT00614744|143151938|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that it does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.29|||Bayesian log binomial models|Bayesian log binomial models were used to analyze the primary outcome of death or moderate/severe disability.|In log binomial models used Normal (0, sd=0.35) neutral prior in the log RR scale. Estimation used Normal weakly informative priors. Reported posterior medians \& 95% credible intervals for the RR above instead of confidence intervals.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|"We fitted all Bayesian models via Markov chain Monte Carlo methods (MCMC) using JAGS (version 3.4) and OpenBUGS (3.2.3) in R (version 3.2.5). For each analysis we ran 3 MCMC chains with starting values randomly drawn from the estimated parameters from a frequentist log binomial model. A burn-in of 1,000 iterations was used, with sampling from a further 10,000 iterations for each chain. To monitor convergence, trace plots and the Gelman-Rubin convergence diagnostic (Rhat) were used for all parameters.~For all analyses, the trace plots show good mixing of the 3 chains with Rhat \< 1.01 for all parameters, indicating convergence."|1.29|0.59|
71824133|NCT03824236|143151969|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (P-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|52.0||||0.003|TWO_SIDED|95.0|28.0|68.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between P-Fx group and the Infectivity Control group.||68|28|0.003
71824134|NCT03824236|143151969|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people (NP-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|54.0||||0.002|TWO_SIDED|95.0|29.0|70.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between NP-Fx group and the Infectivity Control group.||70|29|0.002
71824135|NCT01140347|143151995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.1391|TWO_SIDED|95.0|0.717|1.046|||Log Rank||HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).|||1.046|0.717|0.1391
71824136|NCT01140347|143151996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.625|||<|0.0001|TWO_SIDED|95.0|0.522|0.75|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.750|0.522|<0.0001
71824137|NCT01140347|143151997|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease||||||<0.0001
71824138|NCT01140347|143151998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.487|0.722|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).|||0.722|0.487|<0.0001
71646008|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.7|STANDARD_ERROR_OF_MEAN|2.83||0.0986|TWO_SIDED|90.0|0.02|9.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.38|0.02|0.0986
71646009|NCT02554877|142808224|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.79|STANDARD_ERROR_OF_MEAN|2.85||0.1851|TWO_SIDED|90.0|-0.92|8.5||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||8.50|-0.92|0.1851
71646010|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.39|STANDARD_ERROR_OF_MEAN|2.17||0.8559|TWO_SIDED|90.0|-3.19|3.98||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||3.98|-3.19|0.8559
71646011|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|2.97|STANDARD_ERROR_OF_MEAN|2.17||0.1729|TWO_SIDED|90.0|-0.62|6.55||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.55|-0.62|0.1729
71646012|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|8.45|STANDARD_ERROR_OF_MEAN|2.18||0.0002|TWO_SIDED|90.0|4.84|12.06||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||12.06|4.84|0.0002
71646013|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.37|STANDARD_ERROR_OF_MEAN|2.55||0.8837|TWO_SIDED|90.0|-3.85|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||4.59|-3.85|0.8837
71646014|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.62|STANDARD_ERROR_OF_MEAN|2.55||0.1573|TWO_SIDED|90.0|-0.6|7.84||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||7.84|-0.60|0.1573
71646015|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.88|STANDARD_ERROR_OF_MEAN|2.56||0.0024|TWO_SIDED|90.0|3.65|12.11||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||12.11|3.65|0.0024
71646016|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.59|STANDARD_ERROR_OF_MEAN|2.51||0.1538|TWO_SIDED|90.0|-0.55|7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||7.73|-0.55|0.1538
71646017|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|4.39|STANDARD_ERROR_OF_MEAN|2.48||0.0789|TWO_SIDED|90.0|0.28|8.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||8.49|0.28|0.0789
71646018|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.14|STANDARD_ERROR_OF_MEAN|2.51|<|0.0001|TWO_SIDED|90.0|5.98|14.3||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||14.30|5.98|<0.0001
71646019|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|6.96|STANDARD_ERROR_OF_MEAN|2.78||0.0132|TWO_SIDED|90.0|2.36|11.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.56|2.36|0.0132
71646020|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|7.41|STANDARD_ERROR_OF_MEAN|2.75||0.0079|TWO_SIDED|90.0|2.85|11.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||11.96|2.85|0.0079
71646021|NCT02554877|142808225|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|10.83|STANDARD_ERROR_OF_MEAN|2.77||0.0001|TWO_SIDED|90.0|6.24|15.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||15.42|6.24|0.0001
71646022|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.46|STANDARD_ERROR_OF_MEAN|3.31||0.6597|TWO_SIDED|90.0|-4.01|6.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.92|-4.01|0.6597
71646023|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.02|STANDARD_ERROR_OF_MEAN|3.31||0.7583|TWO_SIDED|90.0|-4.45|6.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||6.49|-4.45|0.7583
71646024|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.11|STANDARD_ERROR_OF_MEAN|3.33||0.3516|TWO_SIDED|90.0|-2.39|8.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||8.61|-2.39|0.3516
71646025|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-1.83|STANDARD_ERROR_OF_MEAN|3.38||0.5877|TWO_SIDED|90.0|-7.42|3.75||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||3.75|-7.42|0.5877
71646026|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.33|STANDARD_ERROR_OF_MEAN|3.38||0.2016|TWO_SIDED|90.0|-9.92|1.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.26|-9.92|0.2016
71646027|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-6.49|STANDARD_ERROR_OF_MEAN|3.39||0.0568|TWO_SIDED|90.0|-12.08|-0.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||-0.89|-12.08|0.0568
71646028|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-2.94|STANDARD_ERROR_OF_MEAN|3.36||0.3827|TWO_SIDED|90.0|-8.48|2.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.61|-8.48|0.3827
71646029|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-5.31|STANDARD_ERROR_OF_MEAN|3.33||0.1126|TWO_SIDED|90.0|-10.81|0.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||0.20|-10.81|0.1126
71646030|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|-4.17|STANDARD_ERROR_OF_MEAN|3.36||0.216|TWO_SIDED|90.0|-9.73|1.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.38|-9.73|0.2160
71646031|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.54|STANDARD_ERROR_OF_MEAN|3.74||0.3443|TWO_SIDED|90.0|-2.64|9.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.72|-2.64|0.3443
71646032|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|3.82|STANDARD_ERROR_OF_MEAN|3.7||0.3031|TWO_SIDED|90.0|-2.3|9.94||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||9.94|-2.30|0.3031
71646033|NCT02554877|142808226|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.88|STANDARD_ERROR_OF_MEAN|3.72||0.8129|TWO_SIDED|90.0|-5.27|7.04||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||7.04|-5.27|0.8129
71646034|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.4||0.402|TWO_SIDED|90.0|-0.33|1.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.01|-0.33|0.4020
71646035|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.06|STANDARD_ERROR_OF_MEAN|0.4||0.8789|TWO_SIDED|90.0|-0.61|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||0.73|-0.61|0.8789
71646036|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.87|STANDARD_ERROR_OF_MEAN|0.41||0.0345|TWO_SIDED|90.0|0.19|1.54||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.||1.54|0.19|0.0345
71646037|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.28|STANDARD_ERROR_OF_MEAN|0.48||0.0087|TWO_SIDED|90.0|0.48|2.08||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.08|0.48|0.0087
71646038|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.08|STANDARD_ERROR_OF_MEAN|0.48||0.0268|TWO_SIDED|90.0|0.28|1.88||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||1.88|0.28|0.0268
71646039|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.49||0.0047|TWO_SIDED|90.0|0.58|2.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.||2.19|0.58|0.0047
71646040|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.07|STANDARD_ERROR_OF_MEAN|0.42||0.0116|TWO_SIDED|90.0|0.38|1.76||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.76|0.38|0.0116
71646041|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.42||0.022|TWO_SIDED|90.0|0.27|1.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||1.66|0.27|0.0220
71646042|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.31|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|90.0|0.62|2.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.||2.01|0.62|0.0021
71646043|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.41|STANDARD_ERROR_OF_MEAN|0.51||0.0067|TWO_SIDED|90.0|0.56|2.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.26|0.56|0.0067
71646044|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.18|STANDARD_ERROR_OF_MEAN|0.51||0.0225|TWO_SIDED|90.0|0.33|2.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.02|0.33|0.0225
71646045|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.4|STANDARD_ERROR_OF_MEAN|0.51||0.0073|TWO_SIDED|90.0|0.55|2.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.||2.25|0.55|0.0073
71646046|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2391|TWO_SIDED|90.0|-0.12|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.73|-0.12|0.2391
71646047|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9912|TWO_SIDED|90.0|-0.42|0.43||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.43|-0.42|0.9912
71886337|NCT01060059|143293280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.094|TWO_SIDED|95.0|0.97|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|0.97|0.094
71886338|NCT01060059|143293280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.259|TWO_SIDED|95.0|1.0|1.01|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.01|1.00|0.259
71646048|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.193|TWO_SIDED|90.0|-0.09|0.77||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||0.77|-0.09|0.1930
71646049|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.0038|TWO_SIDED|90.0|0.35|1.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)||1.25|0.35|0.0038
71646050|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.57|STANDARD_ERROR_OF_MEAN|0.27||0.0394|TWO_SIDED|90.0|0.12|1.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.02|0.12|0.0394
71660957|NCT03118570|142835405|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.15||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.150
71646051|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.48|STANDARD_ERROR_OF_MEAN|0.28||0.0862|TWO_SIDED|90.0|0.02|0.93||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||0.93|0.02|0.0862
71646052|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.05|STANDARD_ERROR_OF_MEAN|0.34||0.0024|TWO_SIDED|90.0|0.48|1.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.61|0.48|0.0024
71646053|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.92|STANDARD_ERROR_OF_MEAN|0.34||0.0068|TWO_SIDED|90.0|0.37|1.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.48|0.37|0.0068
71646054|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.86|STANDARD_ERROR_OF_MEAN|0.34||0.0132|TWO_SIDED|90.0|0.29|1.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.42|0.29|0.0132
71646055|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.39|STANDARD_ERROR_OF_MEAN|0.45||0.0024|TWO_SIDED|90.0|0.65|2.14||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||2.14|0.65|0.0024
71646056|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|1.15|STANDARD_ERROR_OF_MEAN|0.45||0.0115|TWO_SIDED|90.0|0.4|1.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.89|0.40|0.0115
71646057|NCT02554877|142808227|SUPERIORITY_OR_OTHER||LS Mean difference from placebo|0.97|STANDARD_ERROR_OF_MEAN|0.45||0.0344|TWO_SIDED|90.0|0.22|1.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)||1.72|0.22|0.0344
71646058|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|1.54||||0.504|TWO_SIDED|||||Adjusted for TIF introduction and time periods as fixed effects and hospitals and time periods as random effects.|generalized linear mixed regression mode|||For mobility on EU arrival assessed,||||0.504
71646059|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.31||||0.169|TWO_SIDED||||||generalized linear mixed regression mode|||Respiratory rate at EU assessed||||0.169
71646060|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|25.29||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Airway assessed||||0.006
71646061|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|38.38||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Chest examined||||0.001
71646062|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|93.01||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Intra-abdominal bleeding evaluated||||0.001
71824139|NCT01449929|143152008|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.1||||0.025|TWO_SIDED|95.0|0.9|13.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Stratified analysis|Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (\<=100,000 c/mL vs \>100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).|||13.2|0.9|0.025
71824140|NCT01871285|143152027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
71824141|NCT01871285|143152027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
71646063|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|354.91||||0.001|TWO_SIDED||||||generalized linear mixed regression|||For Spine Immobilized for RTI or Fall Victims||||0.001
71646064|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|4.95||||0.001|TWO_SIDED||||||generalized linear mixed regression|||Splinting of Fractures Considered||||0.001
71646065|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|5.18||||0.006|TWO_SIDED||||||generalized linear mixed regression|||Tetanus Considered for bites, burns, lacerations, and abrasions||||0.006
71646066|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.03||||0.047|TWO_SIDED||||||generalized linear mixed regression|||Date of Injury Recorded||||0.047
71646067|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||Death||||0.166
71646068|NCT04547192|142808238|SUPERIORITY|Power calculation - Expected enrollment: 25 patients/hospital/month, giving a total of 3,500 patients across all hospitals over 17.5 months. With an alpha of 0.05 and baseline TIF adherence rate of 50%, there was 80% power to detect 8.1-8.6% difference in KPI performance with 0.15-0.40 range in COV.|Odds Ratio (OR)|2.14||||0.013|TWO_SIDED||||||generalized linear mixed regression|||Important Clinical Data Document||||0.013
71646069|NCT04547192|142808239|SUPERIORITY||Odds Ratio (OR)|0.42||||0.166|TWO_SIDED||||||generalized linear mixed regression|||||||0.166
71646070|NCT00538031|142808450|OTHER|||||||0.61|||||||Log Rank|||||||0.61
71646071|NCT00538031|142808451|OTHER|||||||0.95|||||||Log Rank|||||||0.95
71646072|NCT01484912|142808457|NON_INFERIORITY_OR_EQUIVALENCE|The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||||0.025||95.0|||||t-test, 1 sided|||T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T-△C≦0 with H1：△T-△C﹥0.||||0.025
71646073|NCT01484912|142808458|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||0.005
71646074|NCT01339247|142808463|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0886|||||TWO_SIDED|90.0|1.0011|1.177|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.1770|1.0011|
71646075|NCT01339247|142808464|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0246|||||TWO_SIDED|90.0|0.9676|1.0849|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0849|0.9676|
71646076|NCT01339247|142808465|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon a manufacturing site change.|Ratio T formulation/R formulation|1.0317|||||TWO_SIDED|90.0|0.9716|1.0956|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||1.0956|0.9716|
71646077|NCT00985439|142808500|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.407|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|6.195|16.619|||ANCOVA|||||16.619|6.195|<0.001
71646078|NCT04428307|142808519|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.61|2.02||||||||2.02|0.61|
71646079|NCT04428307|142808519|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.49|1.71||||||||1.71|0.49|
71646080|NCT04428307|142808520|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.83|1.8||||||||1.80|0.83|
71646081|NCT04428307|142808520|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.81|1.62||||||||1.62|0.81|
71646082|NCT04428307|142808521|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.8|1.09||||||||1.09|0.80|
71646083|NCT04428307|142808521|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||||1.16|0.85|
71646084|NCT04428307|142808522|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.75|1.73||||||||1.73|0.75|
71646085|NCT04428307|142808522|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.77|1.74||||||||1.74|0.77|
71646086|NCT04428307|142808523|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
71646087|NCT04428307|142808523|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||||1.04|0.89|
71646088|NCT00924638|142808525|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.4||||0.0006|TWO_SIDED|95.0|1.9|21.7|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||21.7|1.9|0.0006
71646089|NCT00924638|142808526|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.3|||<|0.0001|TWO_SIDED|95.0|2.6|20.8|||Log Rank||A hazard ratio of \> 1 indicates that Continuous Monitoring is superior to Control in detecting AF.|||20.8|2.6|<0.0001
71646090|NCT00924638|142808527|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.32|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.|||1.32|0.35|0.25
71646091|NCT00924638|142808528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|||||TWO_SIDED|95.0|2.8|14.8|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.|||14.8|2.8|
71646092|NCT00924638|142808529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.3|3.1|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.|||3.1|-2.3|
71646093|NCT00924638|142808530|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.11
71646094|NCT00924638|142808531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.33|TWO_SIDED|95.0|0.73|2.6|||Log Rank||A hazard ratio of \< 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.|||2.60|0.73|0.33
71646095|NCT05604014|142808540|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71646096|NCT05604014|142808541|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71646097|NCT05604014|142808542|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
71646098|NCT05604014|142808543|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
71646099|NCT02054715|142808601|OTHER||Mean Difference (MP - PE)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.9621|TWO_SIDED|95.0|-4.1|3.9|||F-Test|||Two-sided F-Test as a statistical comparing MP and PE means.||3.9|-4.1|0.9621
71646100|NCT02054715|142808602|OTHER||Mean Difference (MP - PE)|0.18|STANDARD_ERROR_OF_MEAN|1.57||0.9065|TWO_SIDED|95.0|-2.89|3.26|||F-test|||Two-sided F-Test comparing the MP and PE means.||3.26|-2.89|0.9065
71646101|NCT02054715|142808603|OTHER||Mean Difference (MP - PE)|-0.05|STANDARD_ERROR_OF_MEAN|1.4||0.9709|TWO_SIDED|95.0|-2.79|2.69|||F-Test|||Two-sided F-Test comparing the MP and PE means.||2.69|-2.79|0.9709
71646102|NCT02054715|142808604|OTHER|||||||0.014|||||||Chi-squared|||Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education group||||0.014
71646103|NCT01442376|142808611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|0.36|||||TWO_SIDED|97.5|-11.7|12.4||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||12.4|-11.7|
71646104|NCT01442376|142808611|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|-4.4|||||TWO_SIDED|97.5|-16.4|7.6||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.||7.6|-16.4|
71646105|NCT03499873|142808613|EQUIVALENCE|90% CI on the Test-to-Reference difference for the proportion of subjects with cure should be contained within the interval \[-0.20, +0.20\]|Mean Difference (Net)|-0.026|||||TWO_SIDED|90.0|-0.124|0.073||||||||0.073|-0.124|
71646106|NCT03499873|142808613|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71646107|NCT03499873|142808613|SUPERIORITY|||||||0.0003|||||||ANOVA|||||||0.0003
71646108|NCT01075516|142808621|OTHER|Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71646109|NCT01075516|142808622|OTHER|Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71646110|NCT01075516|142808623|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.8||||||Comparison of utility at baseline from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EuroQoL Group 5-Dimension 3-Level Self-Report (EQ-5D-3L) questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.80
71660958|NCT03118570|142835405|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.468||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.468
71646111|NCT01075516|142808623|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.38||||||Comparison of utility at 12 months from the EQ-5D-3L questionnaire.|t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.38
71646112|NCT01075516|142808623|OTHER|Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).||||||0.53|||||||t-test, 2 sided|||For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).||||0.53
71646113|NCT00834405|142808624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|106.0||||||90.0|98.0|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|98.0|
71646114|NCT00834405|142808625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||115|100|
71646115|NCT02252016|142808627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|23.3||||||The estimated difference (± 95% confidence interval \[CI\]) in percentage of participants experiencing an AE in the Immediate versus Deferred arms was determined.||23.3|-7.3|
71646116|NCT02252016|142808628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.155|TWO_SIDED|95.0|-10.2|1.6|||Miettinen & Nurminen method|||The estimated difference (± 95% CI) in percentage of participants withdrawing from study treatment due to an AE(s) in the Immediate versus Deferred arms was determined.||1.6|-10.2|0.155
71646117|NCT00840281|142808630|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|94.9|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||105|94.9|
71646118|NCT00840281|142808631|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.6|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|98.6|
71646119|NCT00840281|142808632|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103|98.7|
71702425|NCT02489773|142921862|OTHER|The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficient|0.181|||<|0.0001|TWO_SIDED|95.0|0.096|0.265|||t-test, 2 sided|||||0.265|0.096|<0.0001
71646120|NCT00957021|142808706|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||KSS Pain/Motion and Function Score comparison from pre-op to 1, 2 and 5 year||||<.0001
71646121|NCT00957021|142808707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Physical score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
71646122|NCT00957021|142808707|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 1 year||||<.0001
71646123|NCT00957021|142808707|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 2 year||||0.0017
71646124|NCT00957021|142808707|SUPERIORITY_OR_OTHER|||||||0.0055|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 3 year||||0.0055
71646125|NCT00957021|142808707|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 4 year||||0.0050
71646126|NCT00957021|142808707|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 5 year||||0.0018
71646127|NCT00957021|142808709|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||LEAS score comparison from pre-op to 1, 2, 3, 4 and 5 years||||<.0001
71646128|NCT01822119|142808713|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
71646129|NCT01822119|142808714|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation|||||||<0.0001
71702426|NCT02493855|142921875|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.311|||||||Wilcoxon Rank Sum Test|||||||0.311
71702427|NCT02493855|142921875|SUPERIORITY|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.561|||||||Wilcoxon Rank Sum Test|||||||0.561
71646130|NCT01822119|142808715|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant changes with the same value at 500 to 4000Hz||||<0.0001
71646131|NCT01822119|142808715|SUPERIORITY_OR_OTHER|||||||0.0499|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 6000Hz||||0.0499
71646132|NCT01822119|142808715|SUPERIORITY_OR_OTHER|||||||0.0632|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Change at 8000Hz||||0.0632
71646133|NCT01822119|142808716|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.39
71646134|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz||||0.79
71646135|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz||||0.26
71646136|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz||||0.24
71646137|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz||||0.83
71646138|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz||||0.026
71646139|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz||||0.0085
71646140|NCT01822119|142808717|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||8000Hz||||0.13
71646141|NCT01822119|142808718|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Statistically significant improvement with the same value at all presentation levels.||||<0.0001
71646142|NCT01822119|142808719|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||50dB||||0.55
71646143|NCT01822119|142808719|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||60dB||||0.72
71646144|NCT01822119|142808719|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||80dB||||0.28
71646145|NCT01822119|142808720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||<0.0001
71646146|NCT01822119|142808721|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||||||0.0092
71646147|NCT01822119|142808722|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Aversiveness||||0.59
71646148|NCT01822119|142808722|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Ease of Communication||||0.71
71646149|NCT01822119|142808722|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Reverberation||||0.59
71646150|NCT01822119|142808722|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Background noise||||0.40
71646151|NCT01822119|142808722|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Global score||||0.50
71646152|NCT03031795|142808733|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance was set at \< 0.05 for each row comparison with no adjustment for multiple comparisons.|Wilcoxon rank sum test|||"A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from very severe (8) to severe pain (6) or from moderate pain (4) to mild pain (2)."||||< 0.05
71646153|NCT02227238|142808738|SUPERIORITY|Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG - LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.|Proportion difference|13.8|||<|0.001|TWO_SIDED|95.0|7.3|20.3|||Cochran-Mantel-Haenszel||Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.||Superiority would be declared if the lower end of the confidence interval was above 0%|20.3|7.3|<.001
71646154|NCT02227238|142808741|OTHER||Proportion difference|5.7|||||TWO_SIDED|95.0|2.2|9.3|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.|||9.3|2.2|
71646155|NCT02227238|142808741|OTHER||Proportion difference|9.8|||||TWO_SIDED|95.0|5.3|14.4|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.|||14.4|5.3|
71646156|NCT02227238|142808768|OTHER||Mean Difference (Net)|-0.171||||0.001|TWO_SIDED|95.0|-0.272|-0.069|||Multiple imputation||Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.069|-0.272|0.0010
71646157|NCT02227238|142808768|OTHER||Mean Difference (Net)|-0.147||||0.01|TWO_SIDED|95.0|-0.259|-0.035|||'Multiple imputation||Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age|||-0.035|-0.259|0.0100
71646158|NCT02227238|142808769|OTHER||Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.729|-0.356|||Multiple imputation||Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.356|-0.729|<0.0001
71646159|NCT02227238|142808769|OTHER||Mean Difference (Net)|-0.358||||0.0004|TWO_SIDED|95.0|-0.555|-0.161|||Multiple imputation||Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.|||-0.161|-0.555|0.0004
71646160|NCT03966911|142808781|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.0|||<|0.041|TWO_SIDED|91.8|86.05|89.95|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.95|86.05|<0.041
71646161|NCT03966911|142808781|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.96|||<|0.041|TWO_SIDED|91.8|86.13|89.8|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||89.80|86.13|<0.041
71646162|NCT03966911|142808781|SUPERIORITY||Intercept from ANCOVA as agreement rate|84.59||||0.041|TWO_SIDED|91.8|82.02|87.17|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||87.17|82.02|0.041
71646163|NCT03966911|142808781|SUPERIORITY||Intercept from ANCOVA as agreement rate|81.05|||<|0.041|TWO_SIDED|91.8|77.58|84.53|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).|A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041.|||84.53|77.58|<0.041
71646164|NCT01986647|142808784|SUPERIORITY_OR_OTHER|||||||0.2691|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.2691
71646165|NCT01986647|142808785|SUPERIORITY_OR_OTHER|||||||0.6087|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.6087
71646166|NCT01986647|142808786|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0022
71646167|NCT01986647|142808787|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data||||||0.0344
71646168|NCT01986647|142808788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6879|TWO_SIDED|95.0|0.49|1.6|||Regression, Logistic|||||1.60|0.49|0.6879
71646169|NCT01986647|142808789|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.88||||0.5719|TWO_SIDED|95.0|0.56|1.37|||Regression, Logistic|||||1.37|0.56|0.5719
71646170|NCT01986647|142808790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.489|TWO_SIDED|95.0|0.44|5.53|||Regression, Logistic|||||5.53|0.44|0.489
71646171|NCT01986647|142808791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12||||0.2981|TWO_SIDED|95.0|0.37|26.6|||Regression, Logistic|||||26.6|0.37|0.2981
71646172|NCT01986647|142808792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9279|TWO_SIDED|95.0|0.3|3.74|||Regression, Logistic|||||3.74|0.30|0.9279
71646173|NCT01986647|142808793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.5835|TWO_SIDED|95.0|0.67|2.06|||Regression, Logistic|||||2.06|0.67|0.5835
71646174|NCT01986647|142808794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.46||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
71646175|NCT01986647|142808795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.42||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
71646176|NCT01986647|142808796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
71646177|NCT01986647|142808797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.004||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
71646178|NCT01986647|142808798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.44||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71646179|NCT01986647|142808799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0324|TWO_SIDED|95.0|0.29|0.95|||Regression, Logistic|||||0.95|0.29|0.0324
71646180|NCT02003391|142808826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6191|||<|0.0001|ONE_SIDED|95.0||-3.8503|||ANCOVA|||||-3.8503||<0.0001
71646181|NCT02272803|142808831|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.41|1.67|||||Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)|||1.67|0.41|
71646182|NCT00199901|142808853|SUPERIORITY||Hazard Ratio (HR)|0.913|||||TWO_SIDED|95.0|0.532|1.568||||||||1.568|0.532|
71646183|NCT00199901|142808855|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.532|1.455||||||||1.455|0.532|
71646184|NCT00199901|142808856|SUPERIORITY||Hazard Ratio (HR)|0.911|||||TWO_SIDED|95.0|0.514|1.614||||||||1.614|0.514|
71646185|NCT05776901|142808862|OTHER|Descriptive statistics and measures of central tendency, including mean, median, and standard deviation of the System Usability Scores collected from the baseline and week 3 were computed. Then, a two-sided, paired sample t-test was conducted to evaluate the change in mean System Usability Scores from baseline at week 3.|Mean diff in SUS from baseline at week 3|34.17|STANDARD_ERROR_OF_MEAN|14.49|<|0.05|TWO_SIDED|95.0|-28.04|96.37|||t-test, 2 sided|||||96.37|-28.04|<0.05
71646186|NCT00834964|142808930|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|92.72|101.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.49|92.72|
71646187|NCT00834964|142808931|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.7||||||90.0|94.74|104.92|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.92|94.74|
71646188|NCT00834964|142808932|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|93.46|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.02|93.46|
71646189|NCT00834964|142808933|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.29||||||90.0|91.96|100.82|||||Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.|||100.82|91.96|
71824142|NCT01871285|143152028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.7942|TWO_SIDED|95.0|-1.6|1.24|||Mixed Models Analysis|||||1.24|-1.60|.7942
71646190|NCT00834964|142808934|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.1||||||90.0|100.08|108.29|||||Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.|||108.29|100.08|
71646191|NCT00834964|142808935|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.52||||||90.0|97.3|103.84|||||Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.|||103.84|97.30|
71646192|NCT00385736|142808963|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.031
71646193|NCT00385736|142808963|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared|||||||0.833
71646194|NCT00385736|142808964|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.107
71646195|NCT00385736|142808965|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.382
71646196|NCT00385736|142808966|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.038
71646197|NCT00385736|142808967|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.035
71646198|NCT00385736|142808968|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.080
71646199|NCT00385736|142808969|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
71646200|NCT00385736|142808970|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.526
71646201|NCT00385736|142808971|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.506
71646202|NCT00385736|142808972|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.264
71646203|NCT00385736|142808973|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.797
71646204|NCT00385736|142808974|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.614
71646205|NCT00385736|142808975|SUPERIORITY_OR_OTHER|||||||0.532||95.0||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared|||||||0.532
71646206|NCT01911429|142808997|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-8.0||||0.0003|TWO_SIDED|95.0|-12.4|-3.7|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.7|-12.4|0.0003
71646207|NCT01911429|142808997|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-7.7||||0.0006|TWO_SIDED|95.0|-12.1|-3.4|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."||-3.4|-12.1|0.0006
71646208|NCT01911429|142808998|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.47||||0.0003|TWO_SIDED|95.0|-0.73|-0.22|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.22|-0.73|0.0003
71646209|NCT01911429|142808998|SUPERIORITY_OR_OTHER||LS mean difference (SE)|-0.42||||0.0015|TWO_SIDED|95.0|-0.67|-0.16|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.16|-0.67|0.0015
71646210|NCT01662960|142809006|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|2.2||||0.443|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.443
71646211|NCT01662960|142809007|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|0.4||||0.8|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.80
71646212|NCT01662960|142809008|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.002||||0.93|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.93
71646213|NCT01662960|142809010|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|10.7||||0.28|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.28
71646214|NCT01662960|142809011|SUPERIORITY|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.36||||0.86|TWO_SIDED|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA|||||||.86
71646215|NCT01026402|142809048|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|50.0|||||||||||||50mg twice daily continuous dosing 20 evaluable patients|||||
71646216|NCT01026402|142809048|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|100.0|||||||||||||100mg once daily continuous dosing 16 evaluable patients|||||
71646217|NCT01026402|142809048|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|125.0|||||||||||||125mg twice daily intermittent dosing (2 days on, 5 days off) 29 evaluable patients|||||
71646218|NCT00840203|142809064|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|88.6|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|88.6|
71646219|NCT00840203|142809065|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|82.8|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|82.8|
71646220|NCT00840203|142809066|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|94.0||||||90.0|83.0|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|83.0|
71646221|NCT00840203|142809067|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|98.3||||||90.0|91.5|106.0|||||Metabolite results presented for informational purposes only.|||106|91.5|
71646222|NCT00840203|142809068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|86.7|110.0|||||Metabolite results presented for informational purposes only.|||110|86.7|
71646223|NCT00840203|142809069|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|86.1|106.0|||||Metabolite results presented for informational purposes only.|||106|86.1|
71646224|NCT03349567|142809097|SUPERIORITY||Incident rate ratio|0.99||||0.35|TWO_SIDED|95.0|0.98|1.01|||Mixed Models Analysis|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antimicrobial prescription rates.||||1.01|0.98|0.35
71646225|NCT03349567|142809098|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.12|||||TWO_SIDED|95.0|0.93|1.35||||||||1.35|0.93|
71646226|NCT03349567|142809099|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|1.01|||||TWO_SIDED|95.0|0.81|1.27||||||||1.27|0.81|
71646227|NCT03349567|142809100|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.88|||||TWO_SIDED|95.0|0.58|1.34||||||||1.34|0.58|
71646228|NCT03349567|142809101|NON_INFERIORITY|A Poisson regression model with log link was used to estimate the rate of safety outcomes. Models were adjusted for time as a continuous covariate, an indicator for month of implementation of intervention (Oct 2018), and included random effects to account for repeated measurements. An interaction variable for the study period (baseline or intervention) and site (intervention or control) was included in the model to estimate the Incident Rate Ratio (IRR) and 95% CIs.|Incident rate ratio|0.83|||||TWO_SIDED|95.0|0.53|1.29||||||||1.29|0.53|
71646229|NCT03349567|142809102|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71646230|NCT03349567|142809102|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71646231|NCT03349567|142809103|SUPERIORITY|||||||0.46|||||||Regression, Logistic|Segmented regression analysis was conducted using generalized linear models to estimate change in monthly antibiotic prescription rates.||||||0.46
71824143|NCT01871285|143152028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.683||||0.6155|TWO_SIDED|95.0|-11.89|13.25|||Mixed Models Analysis|||||13.25|-11.89|.6155
71646232|NCT01395017|142809128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.3864|TWO_SIDED|95.0|0.85|1.65||The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio \[HR\] =0.75, assuming analysis of 135 deaths).||1.65|0.85|0.3864
71646233|NCT01395017|142809129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.6761|TWO_SIDED|95.0|0.73|1.34||The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (\< 1000 IU/mL or \>/=1000 IU/mL), and RT during trial (yes or no).||Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).||1.34|0.73|0.6761
71646234|NCT00557245|142809165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.56||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.56|0.19|<0.001
71646235|NCT00557245|142809165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.45||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.||0.45|0.13|<0.001
71646236|NCT00557245|142809166|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71646237|NCT00557245|142809166|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher Exact|||||||0.89
71646238|NCT00557245|142809170|SUPERIORITY_OR_OTHER|||||||0.24|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.24
71762725|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|1.45||||0.1138|TWO_SIDED|90.0|-0.06|2.95|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.95|-0.06|0.1138
71646239|NCT00557245|142809170|SUPERIORITY_OR_OTHER|||||||0.49|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.||||||0.49
71646240|NCT00557245|142809171|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.32
71646241|NCT00557245|142809171|SUPERIORITY_OR_OTHER|||||||0.66|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.||||||0.66
71646242|NCT00557245|142809172|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Regression, Logistic|Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.51
71646243|NCT00557245|142809172|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Logistic|generalized estimating equations with logistic link to account for multiple pregnancies and multiple births||||||0.86
71646244|NCT00557245|142809173|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|linear mixed-effects model||||||0.42
71646245|NCT00557245|142809173|SUPERIORITY_OR_OTHER||Slope Difference over time|0.07||||0.08|||||||Mixed Models Analysis|Linear mixed-effects model|Placebo arm is the reference group.|||||0.08
71646246|NCT00557245|142809174|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.02
71646247|NCT00557245|142809174|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||<0.001
71646248|NCT00557245|142809175|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.35
71646249|NCT00557245|142809175|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|Linear mixed effects model||||||0.008
71646250|NCT01127087|142809196|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the RYGB Calcium oxalate (CaOx) Stone Formers arm.||||0.027
71646251|NCT01127087|142809196|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.14
71646252|NCT01127087|142809197|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the RYGB CaOx Stone Formers arm.||||0.018
71646253|NCT01127087|142809197|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.||||0.06
71646254|NCT00828321|142809227|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|94.16||||||90.0|85.08|104.21|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.21|85.08|
71646255|NCT00828321|142809228|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.21|108.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.6|96.21|
71646256|NCT00828321|142809229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.34|108.58|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.58|96.34|
71824144|NCT02501811|143152031|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.05||0.993|TWO_SIDED|95.0|-2.19|2.023|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||2.023|-2.190|0.993
71646257|NCT00828321|142809230|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.52||||||90.0|92.63|104.79|||||This analysis was for informational purposes and was not used to establish bioequivalence.|||104.79|92.63|
71646258|NCT00828321|142809231|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.45||||||90.0|94.66|100.32|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.32|94.66|
71646259|NCT03234907|142809232|SUPERIORITY||Risk Difference (RD)|-5.2|||=|0.347|TWO_SIDED|95.0|-17.2|6.8||P-value was based on CHW test, based on weighted CMH chi-square test, with stratification according to: (1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cui-Hung-Wang (CHW) test||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.8|-17.2|=0.347
71646260|NCT03234907|142809233|SUPERIORITY||Risk Difference (RD)|-2.7|||=|0.531|TWO_SIDED|95.0|-11.5|6.0||P-value based on Cochran-Mantel-Haenszel, weighted CMH chi-square test, with stratification according to:(1)previous failure of TNF-α antagonist therapy/concomitant use of immunomodulators(Yes/No);(2)concomitant use of oral corticosteroids(Yes/No).|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate of the treatment difference and its variance was used to calculate the 95% confidence interval for the treatment difference. Adjustment to the stratification factors was implemented.|||6.0|-11.5|=0.531
71646261|NCT00642993|142809234|SUPERIORITY_OR_OTHER||Difference in means|0.41||||0.187|TWO_SIDED|95.0|-0.2|1.03|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||1.03|-0.20|0.187
71646262|NCT00642993|142809235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.14|TWO_SIDED|95.0|0.28|1.2|||Cochran-Mantel-Haenszel|The P-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||1.20|0.28|0.140
71646263|NCT00642993|142809236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.515|TWO_SIDED|95.0|0.24|9.93|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.||||9.93|0.24|0.515
71646264|NCT00642993|142809237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.543|TWO_SIDED|95.0|-1.2|0.63|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.63|-1.20|0.543
71646265|NCT00642993|142809238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.231|TWO_SIDED|95.0|-0.09|0.35|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.||||0.35|-0.09|0.231
71646266|NCT02664415|142809240|SUPERIORITY|||||||1|||||||Fisher Exact|This is to confirm that the p-value from Fisher's Exact test was 1.000.||||||1.000
71646267|NCT02664415|142809241|SUPERIORITY|||||||0.051|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 20 copies/mL between arms.||||0.051
71646268|NCT02664415|142809241|SUPERIORITY|||||||0.01|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA \>= 1000 copies/mL between arms.||||0.01
71646269|NCT02664415|142809242|SUPERIORITY|||||||0.027||||||This is a p-value, comparing HIV-1 RNA levels at first detection between arms.|Wilcoxon (Mann-Whitney)|||||||0.027
71646270|NCT02664415|142809242|SUPERIORITY|||||||0.588||||||This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.|Wilcoxon (Mann-Whitney)|||||||0.588
71646271|NCT02664415|142809243|SUPERIORITY|||||||0.031|||||||Log Rank|||||||0.031
71646272|NCT02664415|142809245|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||0.693
71646273|NCT02664415|142809246|SUPERIORITY|||||||0.15||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.||||0.15
71646274|NCT02664415|142809246|SUPERIORITY|||||||0.04||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.||||0.04
71646275|NCT02664415|142809246|SUPERIORITY|||||||0.002||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.||||0.002
71646276|NCT02664415|142809246|SUPERIORITY|||||||0.22||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.||||0.22
71646277|NCT02664415|142809246|SUPERIORITY|||||||0.05|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.||||0.05
71646278|NCT02664415|142809246|SUPERIORITY|||||||0.22|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm||||0.22
71646279|NCT02664415|142809249|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at baseline ATI||||0.961
71646280|NCT02664415|142809249|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at ART resumption||||0.805
71646281|NCT02664415|142809249|SUPERIORITY|||||||0.221|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within VRC01 arm.||||0.221
71646282|NCT02664415|142809249|SUPERIORITY|||||||0.5|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within Placebo arm.||||0.500
71646283|NCT02664415|142809250|SUPERIORITY|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups at baseline ATI.||||0.522
71646284|NCT02664415|142809250|SUPERIORITY|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||A comparison between groups at ART resumption.||||0.961
71646285|NCT02664415|142809250|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within VRC01 group.||||0.002
71646286|NCT02664415|142809250|SUPERIORITY|||||||0.043|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within Placebo group.||||0.043
71660959|NCT03118570|142835405|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.8||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.800
71646287|NCT02986139|142809252|SUPERIORITY||LS Mean Difference|-4.0||||0.048|TWO_SIDED|95.0|-8.0|0.0|||Mixed effects analysis of variance model|||A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.||-0.0|-8.0|0.048
71824145|NCT02501811|143152031|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.96||0.499|TWO_SIDED|95.0|-1.229|2.635|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.229|0.499
71824146|NCT02501811|143152031|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.05||0.578|TWO_SIDED|95.0|-0.729|3.485|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.485|-0.729|0.578
71646288|NCT02155257|142809255|OTHER||Slope|0.19||||0.54|TWO_SIDED|95.0|-0.39|0.76|||Regression, Linear|||Interaction between resting pupil diameter and correlation of cognitive-affective style to pain reporting. Note that this analysis is an INTERACTION between the primary outcome of this measure (pupil diameter) to that of the primary outcome measure of cognitive-affective style.||.76|-.39|0.540
71646289|NCT00414726|142809258|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(\>20).||Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.||||0.91
71646290|NCT00414726|142809259|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.||||||0.68
71646291|NCT01630616|142809275|SUPERIORITY_OR_OTHER||Ratio (Adolescents/adults)|0.89|||||TWO_SIDED|90.0|0.62|1.26||||||||1.26|0.62|
71646292|NCT01630616|142809276|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.87|||||TWO_SIDED|90.0|0.62|1.23||||||||1.23|0.62|
71646293|NCT01630616|142809277|SUPERIORITY_OR_OTHER||Ratio (Adolescents/Adults)|0.81|||||TWO_SIDED|90.0|0.57|1.16||||||||1.16|0.57|
71646294|NCT02218541|142809280|OTHER|||||||1||||||threshold for significance will be p-value \<0.05|Fisher Exact|||||||1.00
71646295|NCT02218541|142809281|OTHER|||||||0.039||||||This statistical analysis applies to Yes bleeding|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||0.039
71646296|NCT02218541|142809282|EQUIVALENCE|No power calculation was done as this was a pilot study.||||||1||||||This statistical analysis applies to Yes Provisional Crown fit|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change||||||1.0
71646297|NCT01993186|142809283|SUPERIORITY||Hodges-Lehmann estimate|13.45||||0.5812|TWO_SIDED|90.0|-38.63|80.95|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% confidence interval (CI) and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||80.95|-38.63|0.5812
71646298|NCT01993186|142809286|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.8197|TWO_SIDED|90.0|-51.23|84.25|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||84.25|-51.23|0.8197
71646299|NCT01993186|142809287|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.7276|TWO_SIDED|90.0|0.0|37.5|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test||37.5|0|0.7276
71646300|NCT01993186|142809291|SUPERIORITY||Least squares mean difference|-2.384|STANDARD_ERROR_OF_MEAN|68.1231||0.486|TWO_SIDED|90.0|-114.44|109.67||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTISRTSD||109.67|-114.44|0.486
71646301|NCT01993186|142809291|SUPERIORITY||Least squares mean difference|63.669|STANDARD_ERROR_OF_MEAN|53.0537||0.8849|TWO_SIDED|90.0|-23.6|150.94||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDSRT||150.94|-23.6|0.8849
71646302|NCT01993186|142809291|SUPERIORITY||Least squares mean difference|-63.835|STANDARD_ERROR_OF_MEAN|60.6496||0.1463|TWO_SIDED|90.0|-163.59|35.93||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDFRT||35.93|-163.59|0.1463
71824147|NCT02501811|143152031|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.04||0.523|TWO_SIDED|95.0|-3.552|0.629|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||0.629|-3.552|0.523
71824148|NCT02501811|143152031|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.95||0.471|TWO_SIDED|95.0|-2.7|1.127|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.127|-2.7|0.471
71646303|NCT01993186|142809292|SUPERIORITY||Least squares mean difference|17.768|STANDARD_ERROR_OF_MEAN|11.5659||0.9378|TWO_SIDED|90.0|-1.26|36.79||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALTEA||36.79|-1.26|0.9378
71646304|NCT01993186|142809292|SUPERIORITY||Least squares mean difference|-0.531|STANDARD_ERROR_OF_MEAN|2.1853||0.5959|TWO_SIDED|90.0|-4.13|3.06||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALFTMS||3.06|-4.13|0.5959
71646305|NCT01993186|142809293|SUPERIORITY||Least squares mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.4988||0.4522|TWO_SIDED|90.0|-0.76|0.88||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SSPSLF||0.88|-0.76|0.4522
71646306|NCT01993186|142809294|SUPERIORITY||LS Mean Difference|-1.237|STANDARD_ERROR_OF_MEAN|2.381||0.3017|TWO_SIDED|90.0|-5.15|2.68||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMBE48||2.68|-5.15|0.3017
71646307|NCT01993186|142809294|SUPERIORITY||Least squares mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.6495||0.5235|TWO_SIDED|90.0|-1.03|1.11||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMS68||1.11|-1.03|0.5235
71646308|NCT01993186|142809295|SUPERIORITY||Least squares mean difference|-6.897|STANDARD_ERROR_OF_MEAN|22.4806||0.6205|TWO_SIDED|90.0|-43.874|30.08||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled||30.08|-43.874|0.6205
71646309|NCT01993186|142809296|SUPERIORITY||Least squares mean difference|-1.354|STANDARD_ERROR_OF_MEAN|3.5759||0.6476|TWO_SIDED|90.0|-7.236|4.527||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled (percent predicted)||4.527|-7.236|0.6476
71646310|NCT01993186|142809298|SUPERIORITY||Least squares mean difference|1.568|STANDARD_ERROR_OF_MEAN|3.8899||0.3435|TWO_SIDED|90.0|-4.83|7.97||One-sided p-value. Additional model covariates include baseline GMFM-88 total score, visit and the interaction between visit and treatment.|GEE model|||GMFM-88 UX007-Placebo||7.97|-4.83|0.3435
71646311|NCT01694563|142809379|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.||||0.05
71646312|NCT01694563|142809380|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.||||
71646313|NCT01694563|142809380|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.||||
71646314|NCT01694563|142809380|SUPERIORITY||Clopper-Pearson|90.0|||||TWO_SIDED|90.0||||||||Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.|90% confidence interval using the Clopper-Pearson method.|||
71646315|NCT00829452|142809455|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.03||||||90.0|89.11|103.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.49|89.11|
71646316|NCT00829452|142809456|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|95.34||||||90.0|90.82|100.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.09|90.82|
71646317|NCT00829452|142809457|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|96.98||||||90.0|92.73|101.42|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.42|92.73|
71646318|NCT00829452|142809458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.78||||||90.0|89.34|109.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||109.23|89.34|
71646319|NCT00829452|142809459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.59||||||90.0|94.62|100.66|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.66|94.62|
71646320|NCT01087502|142809474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.24|||ANCOVA|||||-0.24|-0.60|<0.0001
71646321|NCT01087502|142809476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|STANDARD_ERROR_OF_MEAN|6.59||0.1602||95.0|-22.28|3.7|||ANCOVA|||||3.7|-22.28|0.1602
71646322|NCT02705716|142809482|OTHER||Least Square (LS) Mean Difference|-0.12||||0.5191|TWO_SIDED|95.0|-0.497|0.252|||ANCOVA|From ANCOVA Model, Response: change from baseline in Schiff sensitivity score Factors: treatment \& site Covariates: baseline Schiff sensitivity score|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||0.252|-0.497|0.5191
71646323|NCT01451541|142809494|SUPERIORITY_OR_OTHER||LS Means with adjusted pvalues|0.59|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
71646324|NCT01451541|142809494|SUPERIORITY_OR_OTHER||LS Means with adjusted p-values.|0.47|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).||||<0.05
71824149|NCT02501811|143152031|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.95||0.485|TWO_SIDED|95.0|-1.24|2.59|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.590|-1.240|0.485
71646325|NCT00521586|142809560|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|2.8|||||TWO_SIDED|95.0|-1.8|7.4||||||A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang||7.4|-1.8|
71646326|NCT00521586|142809560|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|1.6|||||TWO_SIDED|95.0|-3.9|7.2||||||A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||7.2|-3.9|
71646327|NCT00521586|142809560|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|0.3|||||TWO_SIDED|95.0|-5.6|6.2||||||B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.||6.2|-5.6|
71646328|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.74|||||TWO_SIDED|95.0|0.58|0.95||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.58|
71646329|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.66|
71646330|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.69|||||TWO_SIDED|95.0|0.55|0.87||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.87|0.55|
71646331|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.67|1.05||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.05|0.67|
71646332|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.70|
71646333|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.75|||||TWO_SIDED|95.0|0.6|0.93||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.93|0.60|
71646334|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.63|0.95||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||0.95|0.63|
71646335|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.86|0.59|
71646336|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.6|0.98||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.98|0.60|
71646337|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.88||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||0.88|0.58|
71646338|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.74|
71646339|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.67|1.1||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.10|0.67|
71646340|NCT00521586|142809561|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution||1.08|0.66|
71646341|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.34||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.34|0.83|
71646342|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.75|1.08||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.75|
71646343|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.28|0.92|
71646344|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.08||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.68|
71646345|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.88|1.3||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.30|0.88|
71646346|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.21||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.84|
71646347|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.06||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.78|
71646348|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.48||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.48|0.93|
71646349|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.17||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.17|0.86|
71646350|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.27||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.84|
71646351|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.87|
71824150|NCT02501811|143152032|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.05||0.942|TWO_SIDED|95.0|-2.406|1.887|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values|Confidence intervals based on t-test|||1.887|-2.406|0.942
71646352|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.85|1.31||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.31|0.85|
71646353|NCT00521586|142809562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.27||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.27|0.80|
71646354|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.18|0.87|
71646355|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.10|0.82|
71646356|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.21|0.88|
71646357|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.80|
71646358|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.22||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.22|0.84|
71646359|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
71646360|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.85|
71646361|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.07|0.81|
71646362|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.11||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.11|0.81|
71646363|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.06||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.06|0.79|
71646364|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.08|0.80|
71646365|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.12|0.77|
71646366|NCT00521586|142809571|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.09||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.||1.09|0.74|
71646367|NCT00128219|142809590|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.044|TWO_SIDED|95.0|1.0|58.0||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||58|1|0.044
71646368|NCT00128219|142809615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.12|TWO_SIDED|95.0|0.917|2.34||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher's exact, with GBS III-TT arm in the numerator and Td arm in the denominator so \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||2.34|0.917|0.120
71646369|NCT00128219|142809616|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.089||95.0|-7.0|61.0||Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.|Binomial regression, log-linear link|The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.|Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.|The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.||61|-7|0.089
71646370|NCT00128219|142809617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.256|TWO_SIDED|95.0|0.18|1.45||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher's exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value \<1 favors the GBS III-TT arm.|A two-sided 5% level Fisher's exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher's exact test was inverted to obtain a 95% confidence interval for the odds ratio.||1.45|0.18|0.256
71646371|NCT02034513|142809629|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.94|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.||0.94|0.85|<0.0001
71646372|NCT02034513|142809630|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR \>1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.56|0.73|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was \<1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period.||0.73|0.56|<0.0001
71646373|NCT02034513|142809631|SUPERIORITY_OR_OTHER|||||||0.0016||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in both the maintenance periods. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period.||||0.0016
71646374|NCT02034513|142809633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 437 (n=220 for IDeg and n=217 for IGlar).|Treatment contrast|0.03|||||TWO_SIDED|95.0|-0.1|0.15||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before testing the primary endpoint, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as a prerequisite for testing the primary endpoint. Analysis was based on mixed model for repeated measurement (MMRM); treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates."||0.15|-0.10|
71646375|NCT02034513|142809633|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 410 (n=202 for IDeg and n=208 for IGlar).|Treatment contrast|0.11|||||TWO_SIDED|95.0|0.0|0.23||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was based on MMRM; treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates"||0.23|-0.00|
71646376|NCT01243151|142809649|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.68|STANDARD_ERROR_OF_MEAN|8.323|<|0.0001|TWO_SIDED|95.0|-71.37|-37.99|||ANCOVA|||Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.99|-71.37|<0.0001
71646377|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|8.53|<|0.0001|TWO_SIDED|95.0|-61.28|-27.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.08|-61.28|<0.0001
71646378|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.44|STANDARD_ERROR_OF_MEAN|8.433|<|0.0001|TWO_SIDED|95.0|-81.35|-47.53|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.53|-81.35|<0.0001
71646379|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.75|STANDARD_ERROR_OF_MEAN|8.282|<|0.0001|TWO_SIDED|95.0|-78.36|-45.15|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.15|-78.36|<0.0001
71646380|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-72.16|STANDARD_ERROR_OF_MEAN|10.097|<|0.0001|TWO_SIDED|95.0|-92.4|-51.92|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-51.92|-92.40|<0.0001
71646381|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.89|STANDARD_ERROR_OF_MEAN|10.328|<|0.0001|TWO_SIDED|95.0|-84.59|-43.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.19|-84.59|<0.0001
71824151|NCT02501811|143152032|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|1.17||0.282|TWO_SIDED|95.0|-1.815|2.975|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.975|-1.815|0.282
71824152|NCT02501811|143152032|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.95||0.163|TWO_SIDED|95.0|-1.31|2.635|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.635|-1.310|0.163
71646382|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-88.69|STANDARD_ERROR_OF_MEAN|10.327|<|0.0001|TWO_SIDED|95.0|-109.39|-68.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-68.00|-109.39|<0.0001
71646383|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.65|STANDARD_ERROR_OF_MEAN|10.028|<|0.0001|TWO_SIDED|95.0|-104.76|-64.54|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-64.54|-104.76|<0.0001
71646384|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|8.854|<|0.0001|TWO_SIDED|95.0|-96.22|-60.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.71|-96.22|<0.0001
71646385|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.45|STANDARD_ERROR_OF_MEAN|8.998|<|0.0001|TWO_SIDED|95.0|-102.51|-66.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.40|-102.51|<0.0001
71646386|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-96.08|STANDARD_ERROR_OF_MEAN|8.994|<|0.0001|TWO_SIDED|95.0|-114.12|-78.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-78.03|-114.12|<0.0001
71646387|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.33|STANDARD_ERROR_OF_MEAN|8.703|<|0.0001|TWO_SIDED|95.0|-109.8|-74.86|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.86|-109.80|<0.0001
71646388|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.41|STANDARD_ERROR_OF_MEAN|9.534|<|0.0001|TWO_SIDED|95.0|-90.51|-52.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.30|-90.51|<0.0001
71646389|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.01|STANDARD_ERROR_OF_MEAN|9.659|<|0.0001|TWO_SIDED|95.0|-95.37|-56.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.65|-95.37|<0.0001
71646390|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.78|STANDARD_ERROR_OF_MEAN|9.678|<|0.0001|TWO_SIDED|95.0|-113.18|-74.38|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.38|-113.18|<0.0001
71646391|NCT01243151|142809649|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.58|STANDARD_ERROR_OF_MEAN|9.362|<|0.0001|TWO_SIDED|95.0|-108.35|-70.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-70.81|-108.35|<0.0001
71646392|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.82|STANDARD_ERROR_OF_MEAN|5.077|<|0.0001|TWO_SIDED|95.0|-43.99|-23.65|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.65|-43.99|<0.0001
71646393|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.93|STANDARD_ERROR_OF_MEAN|5.202|<|0.0001|TWO_SIDED|95.0|-38.35|-17.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.51|-38.35|<0.0001
71646394|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.59|STANDARD_ERROR_OF_MEAN|5.143|<|0.0001|TWO_SIDED|95.0|-49.89|-29.28|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.28|-49.89|<0.0001
71646395|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.63|STANDARD_ERROR_OF_MEAN|5.051|<|0.0001|TWO_SIDED|95.0|-47.75|-27.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.51|-47.75|<0.0001
71646396|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.99|STANDARD_ERROR_OF_MEAN|6.384|<|0.0001|TWO_SIDED|95.0|-58.78|-33.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-33.20|-58.78|<0.0001
71646397|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.82|STANDARD_ERROR_OF_MEAN|6.527|<|0.0001|TWO_SIDED|95.0|-54.9|-28.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.74|-54.90|<0.0001
71646398|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.35|STANDARD_ERROR_OF_MEAN|6.531|<|0.0001|TWO_SIDED|95.0|-69.43|-43.27|||ANCOVA|||Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.27|-69.43|<0.0001
71824153|NCT02501811|143152032|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.77||0.175|TWO_SIDED|95.0|-2.471|0.628|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.628|-2.471|0.175
71824154|NCT02501811|143152032|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.03||0.329|TWO_SIDED|95.0|-2.932|1.254|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.254|-2.932|0.329
71824155|NCT02501811|143152032|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.93||0.752|TWO_SIDED|95.0|-1.829|1.994|||ANCOVA|The change in global circumferential strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.994|-1.829|0.752
71824156|NCT02501811|143152033|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.75||0.733|TWO_SIDED|95.0|-1.118|1.927|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.927|-1.118|0.733
71824157|NCT02501811|143152033|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.735|TWO_SIDED|95.0|-1.248|2.041|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.041|-1.248|0.735
71824158|NCT02501811|143152033|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.8||0.794|TWO_SIDED|95.0|-1.464|1.767|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.767|-1.464|0.794
71824159|NCT02501811|143152033|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.7||0.951|TWO_SIDED|95.0|-1.161|1.666|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.666|-1.161|0.951
71824160|NCT02501811|143152033|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.71||0.962|TWO_SIDED|95.0|-1.441|1.457|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.441|0.962
71824161|NCT02501811|143152033|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.76||0.945|TWO_SIDED|95.0|-1.793|1.303|||ANCOVA|The change in regional longitudinal strain was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.303|-1.793|0.945
71824162|NCT02501811|143152034|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|3.85||0.602|TWO_SIDED|95.0|-9.754|5.711|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.711|-9.754|0.602
71824163|NCT02501811|143152034|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|3.39||0.443|TWO_SIDED|95.0|-9.609|4.044|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.044|-9.609|0.443
71824164|NCT02501811|143152034|SUPERIORITY||Mean Difference (Net)|-4.13|STANDARD_ERROR_OF_MEAN|3.42||0.348|TWO_SIDED|95.0|-11.011|2.76|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.760|-11.011|0.348
71824165|NCT02501811|143152034|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|3.92||0.812|TWO_SIDED|95.0|-5.76|9.968|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.968|-5.760|0.812
71824166|NCT02501811|143152034|SUPERIORITY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|3.89||0.9|TWO_SIDED|95.0|-7.052|8.574|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.574|-7.052|0.900
71824167|NCT02501811|143152034|SUPERIORITY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|3.47||0.848|TWO_SIDED|95.0|-8.321|5.635|||ANCOVA|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||5.635|-8.321|0.848
71824168|NCT02501811|143152035|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|3.01||0.659|TWO_SIDED|95.0|-7.281|4.789|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.789|-7.281|0.659
71824169|NCT02501811|143152035|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|3.06||0.466|TWO_SIDED|95.0|-8.621|3.71|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.710|-8.621|0.466
71824170|NCT02501811|143152035|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|3.08||0.293|TWO_SIDED|95.0|-10.799|1.594|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.594|-10.799|0.293
71824171|NCT02501811|143152035|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|3.06||0.53|TWO_SIDED|95.0|-2.795|9.508|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||9.508|-2.795|0.530
71824172|NCT02501811|143152035|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|3.05||0.761|TWO_SIDED|95.0|-4.91|7.33|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||7.330|-4.910|0.761
71824173|NCT02501811|143152035|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|3.12||0.669|TWO_SIDED|95.0|-8.426|4.132|||ANCOVA|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.132|-8.426|0.669
71824174|NCT02501811|143152036|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.989|TWO_SIDED|95.0|-0.048|0.04|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.040|-0.048|0.989
71824175|NCT02501811|143152036|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.493|TWO_SIDED|95.0|-0.056|0.033|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.033|-0.056|0.493
71824176|NCT02501811|143152036|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.926|TWO_SIDED|95.0|-0.053|0.039|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.039|-0.053|0.926
71646399|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.45|STANDARD_ERROR_OF_MEAN|6.344|<|0.0001|TWO_SIDED|95.0|-66.17|-40.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.74|-66.17|<0.0001
71646400|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.67|STANDARD_ERROR_OF_MEAN|5.498|<|0.0001|TWO_SIDED|95.0|-60.7|-38.64|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.64|-60.70|<0.0001
71646401|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.92|STANDARD_ERROR_OF_MEAN|5.592|<|0.0001|TWO_SIDED|95.0|-65.14|-42.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-42.70|-65.14|<0.0001
71646402|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.6|STANDARD_ERROR_OF_MEAN|5.59|<|0.0001|TWO_SIDED|95.0|-71.81|-49.38|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.38|-71.81|<0.0001
71646403|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.67|STANDARD_ERROR_OF_MEAN|5.413|<|0.0001|TWO_SIDED|95.0|-68.53|-46.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.80|-68.53|<0.0001
71646404|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.18|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-55.8|-32.57|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.57|-55.80|<0.0001
71646405|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.28|STANDARD_ERROR_OF_MEAN|5.881|<|0.0001|TWO_SIDED|95.0|-59.06|-35.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.50|-59.06|<0.0001
71646406|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.73|STANDARD_ERROR_OF_MEAN|5.891|<|0.0001|TWO_SIDED|95.0|-69.53|-45.94|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.94|-69.53|<0.0001
71646407|NCT01243151|142809650|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.96|STANDARD_ERROR_OF_MEAN|5.701|<|0.0001|TWO_SIDED|95.0|-66.38|-43.54|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.54|-66.38|<0.0001
71646408|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.972||||0.0472|TWO_SIDED|95.0|1.04|599.65|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||599.65|1.04|0.0472
71646409|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.815||||0.1368|TWO_SIDED|95.0|0.46|305.54|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||305.54|0.46|0.1368
71646410|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.527||||0.019|TWO_SIDED|95.0|1.89|1198.29|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1198.29|1.89|0.0190
71646411|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.328||||0.0192|TWO_SIDED|95.0|1.86|1103.73|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1103.73|1.86|0.0192
71646412|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.273||||0.0105|TWO_SIDED|95.0|2.74|2014.67|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2014.67|2.74|0.0105
71646413|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.088||||0.0086|TWO_SIDED|95.0|3.1|2389.27|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2389.27|3.10|0.0086
71646414|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|87.733||||0.0084|TWO_SIDED|95.0|3.14|2449.11|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2449.11|3.14|0.0084
71646415|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.272||||0.0053|TWO_SIDED|95.0|4.07|3097.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3097.22|4.07|0.0053
71646416|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.697||||0.0403|TWO_SIDED|95.0|1.16|662.2|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||662.20|1.16|0.0403
71646417|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.247||||0.0361|TWO_SIDED|95.0|1.25|733.32|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.32|1.25|0.0361
71646418|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|89.341||||0.0069|TWO_SIDED|95.0|3.43|2326.44|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||2326.44|3.43|0.0069
71646419|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|76.034||||0.0081|TWO_SIDED|95.0|3.08|1875.15|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1875.15|3.08|0.0081
71824177|NCT02501811|143152036|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.904|TWO_SIDED|95.0|-0.041|0.047|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.047|-0.041|0.904
71646420|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.9931|TWO_SIDED|95.0|0.02|64.41|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||64.41|0.02|0.9931
71646421|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.943||||0.0259|TWO_SIDED|95.0|1.55|975.84|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||975.84|1.55|0.0259
71646422|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|57.766||||0.0142|TWO_SIDED|95.0|2.26|1477.88|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1477.88|2.26|0.0142
71646423|NCT01243151|142809651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|48.734||||0.0179|TWO_SIDED|95.0|1.95|1216.9|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1216.90|1.95|0.0179
71646424|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|353.058||||0.0013|TWO_SIDED|95.0|9.95|12528.19|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||12528.19|9.95|0.0013
71646425|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|129.984||||0.0047|TWO_SIDED|95.0|4.44|3808.21|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3808.21|4.44|0.0047
71646426|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|300.099||||0.0018|TWO_SIDED|95.0|8.35|10787.45|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||10787.45|8.35|0.0018
71646427|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|190.835||||0.0025|TWO_SIDED|95.0|6.34|5743.12|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||5743.12|6.34|0.0025
71646428|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|255.421||||0.0018|TWO_SIDED|95.0|7.87|8290.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8290.22|7.87|0.0018
71646429|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|150.547||||0.0034|TWO_SIDED|95.0|5.28|4291.89|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4291.89|5.28|0.0034
71646430|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|745.542||||0.0018|TWO_SIDED|95.0|11.6|47929.45|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||47929.45|11.60|0.0018
71646431|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|146.296||||0.0031|TWO_SIDED|95.0|5.4|3963.01|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3963.01|5.40|0.0031
71646432|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|213.512||||0.002|TWO_SIDED|95.0|7.13|6396.64|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6396.64|7.13|0.0020
71646433|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|124.439||||0.0038|TWO_SIDED|95.0|4.73|3277.13|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||3277.13|4.73|0.0038
71646434|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|622.309||||0.002|TWO_SIDED|95.0|10.51|36846.03|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||36846.03|10.51|0.0020
71646435|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|224.427||||0.0017|TWO_SIDED|95.0|7.63|6598.0|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||6598.00|7.63|0.0017
71646436|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.158||||0.2751|TWO_SIDED|95.0|0.24|161.08|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||161.08|0.24|0.2751
71646437|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|152.977||||0.0038|TWO_SIDED|95.0|5.05|4633.92|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||4633.92|5.05|0.0038
71646438|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|756.203||||0.002|TWO_SIDED|95.0|11.18|51133.53|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||51133.53|11.18|0.0020
71702428|NCT01482221|142921879|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.695||0.63|TWO_SIDED|95.0|-4.519|2.152||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.152|-4.519|0.630
71646439|NCT01243151|142809652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|258.938||||0.0021|TWO_SIDED|95.0|7.53|8902.61|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||8902.61|7.53|0.0021
71646440|NCT01243151|142809653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.958|TWO_SIDED|95.0|0.02|52.79|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||52.79|0.02|0.9580
71646441|NCT01243151|142809653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.375||||0.0732|TWO_SIDED|95.0|0.76|394.65|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||394.65|0.76|0.0732
71646442|NCT01243151|142809653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.86||||0.0159|TWO_SIDED|95.0|2.07|1109.11|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||1109.11|2.07|0.0159
71646443|NCT01243151|142809653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.246||||0.0264|TWO_SIDED|95.0|1.51|733.62|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.||733.62|1.51|0.0264
71646444|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|5.131||0.2883|TWO_SIDED|95.0|-4.77|15.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.77|-4.77|0.2883
71646445|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05|STANDARD_ERROR_OF_MEAN|5.277||0.2563|TWO_SIDED|95.0|-4.51|16.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.61|-4.51|0.2563
71646446|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|5.225||0.7149|TWO_SIDED|95.0|-8.54|12.37|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-8.54|0.7149
71646447|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|5.174||0.448|TWO_SIDED|95.0|-6.4|14.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.30|-6.40|0.4480
71646448|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|6.214||0.0231|TWO_SIDED|95.0|2.06|26.94|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.94|2.06|0.0231
71646449|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|11.13|STANDARD_ERROR_OF_MEAN|6.369||0.0858|TWO_SIDED|95.0|-1.62|23.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.87|-1.62|0.0858
71646450|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|7.57|STANDARD_ERROR_OF_MEAN|6.431||0.244|TWO_SIDED|95.0|-5.3|20.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.44|-5.30|0.2440
71646451|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|STANDARD_ERROR_OF_MEAN|6.249||0.0702|TWO_SIDED|95.0|-0.98|24.03|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.03|-0.98|0.0702
71646452|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|9.64|STANDARD_ERROR_OF_MEAN|4.878||0.0531|TWO_SIDED|95.0|-0.13|19.41|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.41|-0.13|0.0531
71646453|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|8.93|STANDARD_ERROR_OF_MEAN|4.94||0.0758|TWO_SIDED|95.0|-0.96|18.83|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.83|-0.96|0.0758
71646454|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|4.975||0.6965|TWO_SIDED|95.0|-8.01|11.92|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.92|-8.01|0.6965
71646455|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|13.52|STANDARD_ERROR_OF_MEAN|4.842||0.0071|TWO_SIDED|95.0|3.83|23.22|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.22|3.83|0.0071
71646456|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|5.155||0.0339|TWO_SIDED|95.0|0.88|21.52|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.52|0.88|0.0339
71646457|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|8.56|STANDARD_ERROR_OF_MEAN|5.235||0.1075|TWO_SIDED|95.0|-1.92|19.03|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.03|-1.92|0.1075
71646458|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|5.98|STANDARD_ERROR_OF_MEAN|5.258||0.2601|TWO_SIDED|95.0|-4.54|16.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.50|-4.54|0.2601
71646459|NCT01243151|142809654|SUPERIORITY_OR_OTHER||LS Mean Difference|9.96|STANDARD_ERROR_OF_MEAN|5.132||0.057|TWO_SIDED|95.0|-0.31|20.24|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.24|-0.31|0.0570
71762726|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|-0.36||||0.6976|TWO_SIDED|90.0|-1.86|1.15|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.15|-1.86|0.6976
71824178|NCT02501811|143152036|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.476|TWO_SIDED|95.0|-0.035|0.049|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.049|-0.035|0.476
71886339|NCT01060059|143293280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.123|TWO_SIDED|95.0|1.0|1.0|||Regression, Logistic|If several variables had Spearman's rho \> 0.4 (for continuous) and Cramer's V \> 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.||1.00|1.00|0.123
71886340|NCT00848354|143293282|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.||||<0.0001
71886341|NCT00848354|143293283|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||<0.0001
71886342|NCT00848354|143293284|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.||||0.0003
71886343|NCT00848354|143293284|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.||||0.0002
71886344|NCT00848354|143293284|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.||||<0.0001
71886345|NCT00848354|143293285|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.||||0.0270
71886346|NCT00848354|143293286|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71886347|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.39|||<|0.0001|TWO_SIDED|95.0|2.25|18.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||18.2|2.25|<0.0001
71886348|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.62|9.49||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||9.49|2.62|<0.0001
71886349|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|2.19|5.94||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.94|2.19|<0.0001
71886350|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.57|6.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.53|2.57|<0.0001
71886351|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.51|6.16||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.16|2.51|<0.0001
71886352|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.46|5.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||5.93|2.46|<0.0001
71886353|NCT00848354|143293289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.41|8.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||8.53|3.41|<0.0001
71886354|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.37|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.21|2.37|<0.0001
71824179|NCT02501811|143152036|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.515|TWO_SIDED|95.0|-0.04|0.048|||ANCOVA|The change in left ventricular sphericity index was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.048|-0.040|0.515
71886355|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|2.19|5.11||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.11|2.19|<0.0001
71646460|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.88|STANDARD_ERROR_OF_MEAN|5.008|<|0.0001|TWO_SIDED|95.0|-42.93|-22.84|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.84|-42.93|<0.0001
71646461|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-41.34|-20.26|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.26|-41.34|<0.0001
71646462|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.98|STANDARD_ERROR_OF_MEAN|5.088|<|0.0001|TWO_SIDED|95.0|-50.18|-29.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.77|-50.18|<0.0001
71646463|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.37|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-48.54|-28.2|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-28.20|-48.54|<0.0001
71646464|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.18|STANDARD_ERROR_OF_MEAN|6.271|<|0.0001|TWO_SIDED|95.0|-54.73|-29.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.63|-54.73|<0.0001
71646465|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.69|STANDARD_ERROR_OF_MEAN|6.512|<|0.0001|TWO_SIDED|95.0|-55.72|-29.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.67|-55.72|<0.0001
71646466|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.56|STANDARD_ERROR_OF_MEAN|6.445|<|0.0001|TWO_SIDED|95.0|-67.45|-41.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.67|-67.45|<0.0001
71646467|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.89|STANDARD_ERROR_OF_MEAN|6.321|<|0.0001|TWO_SIDED|95.0|-64.54|-39.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.25|-64.54|<0.0001
71646468|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.35|STANDARD_ERROR_OF_MEAN|5.359||95|TWO_SIDED|95.0|-58.1|-36.59|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.59|-58.10|95
71646469|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.08|STANDARD_ERROR_OF_MEAN|5.566|<|0.0001|TWO_SIDED|95.0|-62.24|-39.91|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.91|-62.24|<0.0001
71646470|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.89|STANDARD_ERROR_OF_MEAN|5.482|<|0.0001|TWO_SIDED|95.0|-70.89|-48.89|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.89|-70.89|<0.0001
71824180|NCT02501811|143152037|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.85||0.569|TWO_SIDED|95.0|-1.77|1.687|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.687|-1.770|0.569
71824181|NCT02501811|143152037|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.8||0.767|TWO_SIDED|95.0|-1.792|1.457|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.457|-1.792|0.767
71646471|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.03|STANDARD_ERROR_OF_MEAN|5.377|<|0.0001|TWO_SIDED|95.0|-67.83|-46.24|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-46.24|-67.83|<0.0001
71646472|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.06|STANDARD_ERROR_OF_MEAN|5.767|<|0.0001|TWO_SIDED|95.0|-60.61|-37.51|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.51|-60.61|<0.0001
71646473|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.52|STANDARD_ERROR_OF_MEAN|5.974|<|0.0001|TWO_SIDED|95.0|-63.48|-39.56|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.56|-63.48|<0.0001
71646474|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|5.901|<|0.0001|TWO_SIDED|95.0|-76.04|-52.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.40|-76.04|<0.0001
71646475|NCT01243151|142809655|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.01|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-71.59|-48.42|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-48.42|-71.59|<0.0001
71646476|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.91|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-75.54|-34.29|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.29|-75.54|<0.0001
71646477|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.07|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-65.21|-22.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.94|-65.21|<0.0001
71646478|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.98|STANDARD_ERROR_OF_MEAN|10.547|<|0.0001|TWO_SIDED|95.0|-88.92|-47.05|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.05|-88.92|<0.0001
71646479|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.51|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-81.11|-39.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.90|-81.11|<0.0001
71646480|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.39|STANDARD_ERROR_OF_MEAN|10.392|<|0.0001|TWO_SIDED|95.0|-89.02|-47.76|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-47.76|-89.02|<0.0001
71646481|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.41|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-81.54|-39.27|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.27|-81.54|<0.0001
71646482|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.6|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-107.74|-65.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-65.46|-107.74|<0.0001
71646483|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-81.13|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-101.73|-60.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-60.52|-101.73|<0.0001
71646484|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-100.96|-59.37|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-59.37|-100.96|<0.0001
71646485|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.0|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-104.14|-61.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.87|-104.14|<0.0001
71646486|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.77|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-125.91|-83.62|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-83.62|-125.91|<0.0001
71646487|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.23|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-110.84|-69.63|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.63|-110.84|<0.0001
71646488|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|10.479|<|0.0001|TWO_SIDED|95.0|-92.34|-50.75|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-50.75|-92.34|<0.0001
71646489|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-74.46|STANDARD_ERROR_OF_MEAN|10.646|<|0.0001|TWO_SIDED|95.0|-95.59|-53.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-53.32|-95.59|<0.0001
71646490|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-102.35|STANDARD_ERROR_OF_MEAN|10.656|<|0.0001|TWO_SIDED|95.0|-123.49|-81.21|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-81.21|-123.49|<0.0001
71646491|NCT01243151|142809656|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.15|STANDARD_ERROR_OF_MEAN|10.381|<|0.0001|TWO_SIDED|95.0|-107.76|-66.55|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.55|-107.76|<0.0001
71762727|NCT02785770|143027145|SUPERIORITY_OR_OTHER||LS mean difference|-2.12||||0.0208|TWO_SIDED|90.0|-3.62|-0.61|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.61|-3.62|0.0208
71824182|NCT02501811|143152037|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.71||0.261|TWO_SIDED|95.0|-1.965|0.921|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.921|-1.965|0.261
71824183|NCT02501811|143152037|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.86||0.587|TWO_SIDED|95.0|-1.261|2.222|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.222|-1.261|0.587
71824184|NCT02501811|143152037|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.93||0.994|TWO_SIDED|95.0|-1.763|2.014|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.014|-1.763|0.994
71646492|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.945||0.3064|TWO_SIDED|95.0|-1.89|5.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||5.90|-1.89|0.3064
71646493|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.025||0.1922|TWO_SIDED|95.0|-1.38|6.73|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.73|-1.38|0.1922
71646494|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.984||0.6827|TWO_SIDED|95.0|-3.16|4.79|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.79|-3.16|0.6827
71646495|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|2.45|STANDARD_ERROR_OF_MEAN|1.981||0.2211|TWO_SIDED|95.0|-1.52|6.42|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.42|-1.52|0.2211
71646496|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|6.64|STANDARD_ERROR_OF_MEAN|2.158||0.0033|TWO_SIDED|95.0|2.31|10.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.97|2.31|0.0033
71646497|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|5.09|STANDARD_ERROR_OF_MEAN|2.237||0.0269|TWO_SIDED|95.0|0.6|9.57|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.57|0.60|0.0269
71646498|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|2.232||0.089|TWO_SIDED|95.0|-0.61|8.34|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.34|-0.61|0.0890
71646499|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|2.19||0.0242|TWO_SIDED|95.0|0.69|9.47|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.47|0.69|0.0242
71646500|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|2.101||0.127|TWO_SIDED|95.0|-0.95|7.46|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-0.95|0.1270
71646501|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.151||0.1199|TWO_SIDED|95.0|-0.91|7.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.70|-0.91|0.1199
71646502|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.15||0.8123|TWO_SIDED|95.0|-3.79|4.82|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||4.82|-3.79|0.8123
71646503|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|2.106||0.0095|TWO_SIDED|95.0|1.44|9.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||9.87|1.44|0.0095
71646504|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.492||0.1141|TWO_SIDED|95.0|-0.99|8.99|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.99|-0.99|0.1141
71646505|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.536||0.1552|TWO_SIDED|95.0|-1.42|8.73|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.73|-1.42|0.1552
71824185|NCT02501811|143152037|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.81||0.639|TWO_SIDED|95.0|-1.993|1.283|||ANCOVA|The change in scar size percent was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.283|-1.993|0.639
71824186|NCT02501811|143152038|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.42||0.992|TWO_SIDED|95.0|-2.437|3.319|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.319|-2.437|0.992
71646506|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|1.57|STANDARD_ERROR_OF_MEAN|2.547||0.5407|TWO_SIDED|95.0|-3.53|6.67|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||6.67|-3.53|0.5407
71824187|NCT02501811|143152038|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.22||0.862|TWO_SIDED|95.0|-2.278|2.643|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||2.643|-2.278|0.862
71824188|NCT02501811|143152038|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|1.31||0.217|TWO_SIDED|95.0|-3.846|1.443|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.443|-3.846|0.217
71824189|NCT02501811|143152038|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.47||0.327|TWO_SIDED|95.0|-1.325|4.611|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||4.611|-1.325|0.327
71824190|NCT02501811|143152038|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.39||0.859|TWO_SIDED|95.0|-2.551|3.068|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||3.068|-2.551|0.859
71824191|NCT02501811|143152038|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.27||0.338|TWO_SIDED|95.0|-3.952|1.184|||ANCOVA|The change in scar tissue mass was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||1.184|-3.952|0.338
71824192|NCT02501811|143152039|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.71||0.157|TWO_SIDED|95.0|-2.456|0.411|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.411|-2.456|0.157
71824193|NCT02501811|143152039|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.9||0.428|TWO_SIDED|95.0|-2.798|0.859|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||0.859|-2.798|0.428
71824194|NCT02501811|143152039|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.73||0.382|TWO_SIDED|95.0|-0.83|2.093|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||2.093|-0.83|0.382
71824195|NCT02501811|143152039|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.8||0.056|TWO_SIDED|95.0|-3.255|-0.052|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.052|-3.255|0.056
71824196|NCT02501811|143152039|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.96||0.61|TWO_SIDED|95.0|-1.991|1.885|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||1.885|-1.991|0.610
71824197|NCT02501811|143152039|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.356|3.557|||ANCOVA|The change in peak VO2 was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||3.557|-0.356|0.195
71824198|NCT02501811|143152040|SUPERIORITY||Mean Difference (Final Values)|18.57|STANDARD_ERROR_OF_MEAN|19.01||0.348|TWO_SIDED|95.0|-19.537|56.687|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||56.687|-19.537|0.348
71824199|NCT02501811|143152040|SUPERIORITY||Mean Difference (Final Values)|23.19|STANDARD_ERROR_OF_MEAN|17.88||0.23|TWO_SIDED|95.0|-12.759|59.134|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||59.134|-12.759|0.230
71824200|NCT02501811|143152040|SUPERIORITY||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|16.21||0.905|TWO_SIDED|95.0|-30.974|34.361|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||34.361|-30.974|0.905
71824201|NCT02501811|143152040|SUPERIORITY||Mean Difference (Final Values)|16.88|STANDARD_ERROR_OF_MEAN|15.98||0.335|TWO_SIDED|95.0|-15.267|49.03|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||49.030|-15.267|0.335
71824202|NCT02501811|143152040|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|17.68||0.827|TWO_SIDED|95.0|-40.106|30.88|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||30.880|-40.106|0.827
71824203|NCT02501811|143152040|SUPERIORITY||Mean Difference (Final Values)|-21.49|STANDARD_ERROR_OF_MEAN|14.63||0.163|TWO_SIDED|95.0|-50.989|8.001|||ANCOVA|The change in exercise tolerance was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.001|-50.989|0.163
71824204|NCT02501811|143152041|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.63||0.023|TWO_SIDED|95.0|-18.915|-0.357|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-0.357|-18.915|0.023
71824205|NCT02501811|143152041|SUPERIORITY||Mean Difference (Final Values)|-15.09|STANDARD_ERROR_OF_MEAN|5.84||0.05|TWO_SIDED|95.0|-26.871|-3.319|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||-3.319|-26.871|0.050
71824206|NCT02501811|143152041|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|5.86||0.119|TWO_SIDED|95.0|-14.784|8.836|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||8.836|-14.784|0.119
71824207|NCT02501811|143152041|SUPERIORITY||Mean Difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|5.66||0.845|TWO_SIDED|95.0|-18.087|4.762|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||4.762|-18.087|0.845
71824208|NCT02501811|143152041|SUPERIORITY||Mean Difference (Final Values)|5.46|STANDARD_ERROR_OF_MEAN|5.64||0.976|TWO_SIDED|95.0|-5.931|16.848|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||16.848|-5.931|0.976
71886356|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.9|4.43||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||4.43|1.90|<0.0001
71646507|NCT01243151|142809657|SUPERIORITY_OR_OTHER||LS Mean Difference|6.56|STANDARD_ERROR_OF_MEAN|2.485||0.0107|TWO_SIDED|95.0|1.58|11.53|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||11.53|1.58|0.0107
71646508|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.35|STANDARD_ERROR_OF_MEAN|8.152|<|0.0001|TWO_SIDED|95.0|-76.74|-43.97|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.97|-76.74|<0.0001
71646509|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.53|STANDARD_ERROR_OF_MEAN|8.422|<|0.0001|TWO_SIDED|95.0|-69.45|-35.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-35.61|-69.45|<0.0001
71646510|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-69.46|STANDARD_ERROR_OF_MEAN|8.26|<|0.0001|TWO_SIDED|95.0|-86.06|-52.86|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-52.86|-86.06|<0.0001
71646511|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.25|STANDARD_ERROR_OF_MEAN|8.112|<|0.0001|TWO_SIDED|95.0|-82.55|-49.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.94|-82.55|<0.0001
71646512|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.46|STANDARD_ERROR_OF_MEAN|10.766|<|0.0001|TWO_SIDED|95.0|-100.05|-56.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-56.87|-100.05|<0.0001
71646513|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.28|STANDARD_ERROR_OF_MEAN|11.051|<|0.0001|TWO_SIDED|95.0|-93.43|-49.13|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-49.13|-93.43|<0.0001
71646514|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-91.83|STANDARD_ERROR_OF_MEAN|11.018|<|0.0001|TWO_SIDED|95.0|-113.92|-69.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.74|-113.92|<0.0001
71646515|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-89.5|STANDARD_ERROR_OF_MEAN|10.736|<|0.0001|TWO_SIDED|95.0|-111.03|-67.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-67.97|-111.03|<0.0001
71646516|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.73|STANDARD_ERROR_OF_MEAN|8.452|<|0.0001|TWO_SIDED|95.0|-103.73|-69.72|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-69.72|-103.73|<0.0001
71646517|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-92.18|STANDARD_ERROR_OF_MEAN|8.643|<|0.0001|TWO_SIDED|95.0|-109.57|-74.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-74.80|-109.57|<0.0001
71646518|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-106.06|STANDARD_ERROR_OF_MEAN|8.585|<|0.0001|TWO_SIDED|95.0|-123.34|-88.78|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-88.78|-123.34|<0.0001
71646519|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-99.18|STANDARD_ERROR_OF_MEAN|8.334|<|0.0001|TWO_SIDED|95.0|-115.95|-82.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-82.40|-115.95|<0.0001
71646520|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-79.07|STANDARD_ERROR_OF_MEAN|8.557|<|0.0001|TWO_SIDED|95.0|-96.22|-61.93|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-61.93|-96.22|<0.0001
71646521|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.89|STANDARD_ERROR_OF_MEAN|8.736|<|0.0001|TWO_SIDED|95.0|-101.4|-66.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-66.39|-101.40|<0.0001
71646522|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-104.74|STANDARD_ERROR_OF_MEAN|8.679|<|0.0001|TWO_SIDED|95.0|-122.13|-87.35|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-87.35|-122.13|<0.0001
71646523|NCT01243151|142809658|SUPERIORITY_OR_OTHER||LS Mean Difference|-97.0|STANDARD_ERROR_OF_MEAN|8.426|<|0.0001|TWO_SIDED|95.0|-113.89|-80.11|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-80.11|-113.89|<0.0001
71824209|NCT02501811|143152041|SUPERIORITY||Mean Difference (Final Values)|12.12|STANDARD_ERROR_OF_MEAN|6.69||0.717|TWO_SIDED|95.0|-1.337|25.578|||ANCOVA|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t test|||25.578|-1.337|0.717
71702429|NCT01482221|142921879|SUPERIORITY_OR_OTHER||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|1.701||0.476|TWO_SIDED|95.0|-4.563|2.134||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.134|-4.563|0.476
71646524|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|29.336||0.448|TWO_SIDED|95.0|-80.08|35.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.49|-80.08|0.4480
71646525|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.52|STANDARD_ERROR_OF_MEAN|30.091||0.2809|TWO_SIDED|95.0|-91.8|26.76|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.76|-91.80|0.2809
71646526|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.92|STANDARD_ERROR_OF_MEAN|29.942||0.2875|TWO_SIDED|95.0|-90.9|27.07|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.07|-90.90|0.2875
71646527|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|29.37||0.5743|TWO_SIDED|95.0|-74.38|41.33|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||41.33|-74.38|0.5743
71646528|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.83|STANDARD_ERROR_OF_MEAN|29.336||0.4997|TWO_SIDED|95.0|-77.62|37.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.96|-77.62|0.4997
71646529|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|30.091||0.4756|TWO_SIDED|95.0|-80.78|37.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||37.78|-80.78|0.4756
71646530|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.73|STANDARD_ERROR_OF_MEAN|30.458||0.561|TWO_SIDED|95.0|-77.73|42.26|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||42.26|-77.73|0.5610
71646531|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.41|STANDARD_ERROR_OF_MEAN|29.37||0.4667|TWO_SIDED|95.0|-79.27|36.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||36.44|-79.27|0.4667
71646532|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|29.828||0.3045|TWO_SIDED|95.0|-89.45|28.06|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||28.06|-89.45|0.3045
71646533|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.78|STANDARD_ERROR_OF_MEAN|30.091||0.4301|TWO_SIDED|95.0|-83.06|35.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.50|-83.06|0.4301
71646534|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.15|STANDARD_ERROR_OF_MEAN|30.458||0.0881|TWO_SIDED|95.0|-112.15|7.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.85|-112.15|0.0881
71646535|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.51|STANDARD_ERROR_OF_MEAN|29.37||0.2844|TWO_SIDED|95.0|-89.36|26.35|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.35|-89.36|0.2844
71646536|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.56|STANDARD_ERROR_OF_MEAN|29.828||0.3741|TWO_SIDED|95.0|-85.32|32.19|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||32.19|-85.32|0.3741
71646537|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.88|STANDARD_ERROR_OF_MEAN|30.091||0.4283|TWO_SIDED|95.0|-83.16|35.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||35.40|-83.16|0.4283
71646538|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.32|STANDARD_ERROR_OF_MEAN|30.458||0.0657|TWO_SIDED|95.0|-116.31|3.68|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||3.68|-116.31|0.0657
71646539|NCT01243151|142809659|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.26|STANDARD_ERROR_OF_MEAN|29.37||0.2586|TWO_SIDED|95.0|-91.11|24.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||24.60|-91.11|0.2586
71646540|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|STANDARD_ERROR_OF_MEAN|3.404||0.3326|TWO_SIDED|95.0|-3.49|10.14|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.14|-3.49|0.3326
71702430|NCT01482221|142921880|SUPERIORITY_OR_OTHER||LS mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.816||0.63|TWO_SIDED|95.0|-5.628|1.522||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.522|-5.628|0.630
71702431|NCT01482221|142921880|SUPERIORITY_OR_OTHER||LS mean difference|0.88|STANDARD_ERROR_OF_MEAN|1.83||0.63|TWO_SIDED|95.0|-2.72|4.485||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.||4.485|-2.720|0.630
71646541|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|3.69|STANDARD_ERROR_OF_MEAN|3.502||0.2967|TWO_SIDED|95.0|-3.32|10.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.70|-3.32|0.2967
71646542|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|3.466||0.8812|TWO_SIDED|95.0|-6.42|7.46|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||7.46|-6.42|0.8812
71646543|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|3.433||0.3227|TWO_SIDED|95.0|-3.45|10.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.30|-3.45|0.3227
71646544|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|10.01|STANDARD_ERROR_OF_MEAN|4.221||0.021|TWO_SIDED|95.0|1.56|18.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.46|1.56|0.0210
71646545|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|4.326||0.1192|TWO_SIDED|95.0|-1.82|15.49|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.49|-1.82|0.1192
71646546|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|5.04|STANDARD_ERROR_OF_MEAN|4.367||0.2529|TWO_SIDED|95.0|-3.69|13.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.78|-3.69|0.2529
71646547|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|4.244||0.0725|TWO_SIDED|95.0|-0.73|16.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.25|-0.73|0.0725
71646548|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|3.214||0.0405|TWO_SIDED|95.0|0.3|13.18|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.18|0.30|0.0405
71646549|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|6.27|STANDARD_ERROR_OF_MEAN|3.258||0.0593|TWO_SIDED|95.0|-0.25|12.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.80|-0.25|0.0593
71646550|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|3.279||0.5936|TWO_SIDED|95.0|-4.81|8.33|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.33|-4.81|0.5936
71646551|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|9.78|STANDARD_ERROR_OF_MEAN|3.192||0.0034|TWO_SIDED|95.0|3.38|16.17|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.17|3.38|0.0034
71646552|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.428||0.0305|TWO_SIDED|95.0|0.74|14.46|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.46|0.74|0.0305
71646553|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|5.41|STANDARD_ERROR_OF_MEAN|3.479||0.1252|TWO_SIDED|95.0|-1.55|12.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.37|-1.55|0.1252
71646554|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|3.495||0.2923|TWO_SIDED|95.0|-3.28|10.71|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.71|-3.28|0.2923
71646555|NCT01243151|142809660|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|3.411||0.0297|TWO_SIDED|95.0|0.78|14.43|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||14.43|0.78|0.0297
71646556|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.117|<|0.0001|TWO_SIDED|95.0|-34.59|-18.1|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.10|-34.59|<0.0001
71646557|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.29|STANDARD_ERROR_OF_MEAN|4.325|<|0.0001|TWO_SIDED|95.0|-32.95|-15.63|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-15.63|-32.95|<0.0001
71646558|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|STANDARD_ERROR_OF_MEAN|4.182|<|0.0001|TWO_SIDED|95.0|-39.58|-22.83|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.83|-39.58|<0.0001
71646559|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.43|STANDARD_ERROR_OF_MEAN|4.169|<|0.0001|TWO_SIDED|95.0|-38.78|-22.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.08|-38.78|<0.0001
71646560|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.3|STANDARD_ERROR_OF_MEAN|5.055|<|0.0001|TWO_SIDED|95.0|-43.42|-23.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.19|-43.42|<0.0001
71646561|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.14|STANDARD_ERROR_OF_MEAN|5.255|<|0.0001|TWO_SIDED|95.0|-44.65|-23.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-23.63|-44.65|<0.0001
71646562|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.57|STANDARD_ERROR_OF_MEAN|5.194|<|0.0001|TWO_SIDED|95.0|-52.96|-32.18|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.18|-52.96|<0.0001
71646563|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.87|STANDARD_ERROR_OF_MEAN|5.097|<|0.0001|TWO_SIDED|95.0|-52.07|-31.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.67|-52.07|<0.0001
71646564|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.75|STANDARD_ERROR_OF_MEAN|4.343|<|0.0001|TWO_SIDED|95.0|-46.46|-29.05|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.05|-46.46|<0.0001
71646565|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.98|STANDARD_ERROR_OF_MEAN|4.519|<|0.0001|TWO_SIDED|95.0|-50.04|-31.93|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.93|-50.04|<0.0001
71646566|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.98|STANDARD_ERROR_OF_MEAN|4.441|<|0.0001|TWO_SIDED|95.0|-55.88|-38.08|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.08|-55.88|<0.0001
71646567|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.77|STANDARD_ERROR_OF_MEAN|4.363|<|0.0001|TWO_SIDED|95.0|-54.52|-37.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-37.03|-54.52|<0.0001
71646568|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.61|STANDARD_ERROR_OF_MEAN|4.616|<|0.0001|TWO_SIDED|95.0|-47.85|-29.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.37|-47.85|<0.0001
71646569|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.19|STANDARD_ERROR_OF_MEAN|4.795|<|0.0001|TWO_SIDED|95.0|-50.78|-31.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-31.60|-50.78|<0.0001
71702432|NCT01482221|142921881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|STANDARD_ERROR_OF_MEAN|0.366||0.852|TWO_SIDED|95.0|0.544|2.089||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.089|0.544|0.852
71646570|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.75|STANDARD_ERROR_OF_MEAN|4.722|<|0.0001|TWO_SIDED|95.0|-59.2|-40.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-40.30|-59.20|<0.0001
71646571|NCT01243151|142809661|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.04|STANDARD_ERROR_OF_MEAN|4.639|<|0.0001|TWO_SIDED|95.0|-57.33|-38.76|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-38.76|-57.33|<0.0001
71646572|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-31.06|-14.34|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-14.34|-31.06|<0.0001
71646573|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-27.17|-10.03|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-10.03|-27.17|<0.0001
71646574|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.97|STANDARD_ERROR_OF_MEAN|4.274|<|0.0001|TWO_SIDED|95.0|-36.46|-19.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-19.49|-36.46|<0.0001
71646575|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.89|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-33.24|-16.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-16.54|-33.24|<0.0001
71646576|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.89|STANDARD_ERROR_OF_MEAN|4.211|<|0.0001|TWO_SIDED|95.0|-37.25|-20.53|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-20.53|-37.25|<0.0001
71646577|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.35|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-34.92|-17.79|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-17.79|-34.92|<0.0001
71646578|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.89|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-44.46|-27.33|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.33|-44.46|<0.0001
71646579|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.23|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-42.58|-25.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.88|-42.58|<0.0001
71646580|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.96|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-42.39|-25.53|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.53|-42.39|<0.0001
71646581|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.41|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-43.98|-26.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.85|-43.98|<0.0001
71646582|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-51.85|-34.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.71|-51.85|<0.0001
71646583|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.0|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-46.35|-29.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-29.65|-46.35|<0.0001
71646584|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.77|STANDARD_ERROR_OF_MEAN|4.246|<|0.0001|TWO_SIDED|95.0|-38.19|-21.34|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-21.34|-38.19|<0.0001
71646585|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.22|STANDARD_ERROR_OF_MEAN|4.315|<|0.0001|TWO_SIDED|95.0|-39.79|-22.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.65|-39.79|<0.0001
71646586|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.34|STANDARD_ERROR_OF_MEAN|4.318|<|0.0001|TWO_SIDED|95.0|-49.91|-32.78|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.78|-49.91|<0.0001
71762728|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-0.64||||0.576|TWO_SIDED|90.0|-2.53|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-2.53|0.5760
71646587|NCT01243151|142809662|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.04|STANDARD_ERROR_OF_MEAN|4.207|<|0.0001|TWO_SIDED|95.0|-44.39|-27.69|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.69|-44.39|<0.0001
71824210|NCT02501811|143152042|SUPERIORITY||Mean Difference (Final Values)|-1411.7|STANDARD_ERROR_OF_MEAN|840.6||0.11|TWO_SIDED|95.0|-3108.3|284.9|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||284.9|-3108.3|0.110
71646588|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|3.975||0.269|TWO_SIDED|95.0|-3.53|12.41|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||12.41|-3.53|0.2690
71646589|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|5.22|STANDARD_ERROR_OF_MEAN|4.133||0.2122|TWO_SIDED|95.0|-3.07|13.5|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.50|-3.07|0.2122
71646590|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|4.054||0.8953|TWO_SIDED|95.0|-7.59|8.67|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||8.67|-7.59|0.8953
71646591|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|STANDARD_ERROR_OF_MEAN|4.045||0.1723|TWO_SIDED|95.0|-2.51|13.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.70|-2.51|0.1723
71646592|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|14.95|STANDARD_ERROR_OF_MEAN|4.293||0.001|TWO_SIDED|95.0|6.34|23.56|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.56|6.34|0.0010
71646593|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|10.86|STANDARD_ERROR_OF_MEAN|4.451||0.0179|TWO_SIDED|95.0|1.95|19.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.78|1.95|0.0179
71646594|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|4.44||0.0462|TWO_SIDED|95.0|0.16|17.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||17.96|0.16|0.0462
71646595|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|11.78|STANDARD_ERROR_OF_MEAN|4.358||0.0091|TWO_SIDED|95.0|3.05|20.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.52|3.05|0.0091
71646596|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|7.31|STANDARD_ERROR_OF_MEAN|4.064||0.0774|TWO_SIDED|95.0|-0.83|15.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.45|-0.83|0.0774
71646597|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16|STANDARD_ERROR_OF_MEAN|4.165||0.0909|TWO_SIDED|95.0|-1.18|15.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||15.50|-1.18|0.0909
71646598|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|4.157||0.6107|TWO_SIDED|95.0|-6.2|10.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||10.45|-6.20|0.6107
71646599|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|11.59|STANDARD_ERROR_OF_MEAN|4.076||0.0062|TWO_SIDED|95.0|3.42|19.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||19.75|3.42|0.0062
71646600|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|8.69|STANDARD_ERROR_OF_MEAN|4.712||0.0702|TWO_SIDED|95.0|-0.74|18.13|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||18.13|-0.74|0.0702
71646601|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|6.69|STANDARD_ERROR_OF_MEAN|4.807||0.1692|TWO_SIDED|95.0|-2.93|16.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||16.32|-2.93|0.1692
71646602|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|4.819||0.3751|TWO_SIDED|95.0|-5.34|13.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||13.96|-5.34|0.3751
71824211|NCT02501811|143152042|SUPERIORITY||Mean Difference (Final Values)|-634.6|STANDARD_ERROR_OF_MEAN|405.1||0.112|TWO_SIDED|95.0|-1460.7|191.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||191.4|-1460.7|0.112
71646603|NCT01243151|142809663|SUPERIORITY_OR_OTHER||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|4.709||0.0053|TWO_SIDED|95.0|4.23|23.08|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||23.08|4.23|0.0053
71646604|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.64|STANDARD_ERROR_OF_MEAN|3.951|<|0.0001|TWO_SIDED|95.0|-38.56|-22.72|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-22.72|-38.56|<0.0001
71646605|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.62|STANDARD_ERROR_OF_MEAN|4.084|<|0.0001|TWO_SIDED|95.0|-34.8|-18.44|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-18.44|-34.80|<0.0001
71646606|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.27|STANDARD_ERROR_OF_MEAN|4.003|<|0.0001|TWO_SIDED|95.0|-43.29|-27.24|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-27.24|-43.29|<0.0001
71646607|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.42|STANDARD_ERROR_OF_MEAN|3.931|<|0.0001|TWO_SIDED|95.0|-41.3|-25.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-25.54|-41.30|<0.0001
71646608|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.38|STANDARD_ERROR_OF_MEAN|5.467|<|0.0001|TWO_SIDED|95.0|-52.34|-30.42|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-30.42|-52.34|<0.0001
71646609|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.12|STANDARD_ERROR_OF_MEAN|5.61|<|0.0001|TWO_SIDED|95.0|-49.36|-26.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-26.88|-49.36|<0.0001
71646610|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.42|STANDARD_ERROR_OF_MEAN|5.599|<|0.0001|TWO_SIDED|95.0|-58.64|-36.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.20|-58.64|<0.0001
71646611|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.93|STANDARD_ERROR_OF_MEAN|5.453|<|0.0001|TWO_SIDED|95.0|-57.87|-36.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.00|-57.87|<0.0001
71646612|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.37|STANDARD_ERROR_OF_MEAN|4.275|<|0.0001|TWO_SIDED|95.0|-53.96|-36.77|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-36.77|-53.96|<0.0001
71646613|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.78|STANDARD_ERROR_OF_MEAN|4.374|<|0.0001|TWO_SIDED|95.0|-57.58|-39.99|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-39.99|-57.58|<0.0001
71646614|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.49|STANDARD_ERROR_OF_MEAN|4.346|<|0.0001|TWO_SIDED|95.0|-63.23|-45.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-45.75|-63.23|<0.0001
71646615|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.75|STANDARD_ERROR_OF_MEAN|4.222|<|0.0001|TWO_SIDED|95.0|-60.25|-43.26|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.26|-60.25|<0.0001
71646616|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.82|STANDARD_ERROR_OF_MEAN|4.373|<|0.0001|TWO_SIDED|95.0|-49.58|-32.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-32.07|-49.58|<0.0001
71646617|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.75|STANDARD_ERROR_OF_MEAN|4.464|<|0.0001|TWO_SIDED|95.0|-52.68|-34.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-34.81|-52.68|<0.0001
71646618|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.36|STANDARD_ERROR_OF_MEAN|4.437|<|0.0001|TWO_SIDED|95.0|-61.25|-43.48|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-43.48|-61.25|<0.0001
71646619|NCT01243151|142809664|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.94|STANDARD_ERROR_OF_MEAN|4.312|<|0.0001|TWO_SIDED|95.0|-58.58|-41.31|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||-41.31|-58.58|<0.0001
71886357|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.06|4.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||4.96|2.06|<0.0001
71824212|NCT02501811|143152042|SUPERIORITY||Mean Difference (Final Values)|-483.2|STANDARD_ERROR_OF_MEAN|400.7||0.891|TWO_SIDED|95.0|-1301.5|335.2|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||335.2|-1301.5|0.891
71646620|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|19.581||0.9789|TWO_SIDED|95.0|-39.08|38.04|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||38.04|-39.08|0.9789
71646621|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.94|STANDARD_ERROR_OF_MEAN|20.069||0.5525|TWO_SIDED|95.0|-51.46|27.59|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.59|-51.46|0.5525
71646622|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.39|STANDARD_ERROR_OF_MEAN|19.979||0.5035|TWO_SIDED|95.0|-52.73|25.96|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.96|-52.73|0.5035
71646623|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|19.601||0.8302|TWO_SIDED|95.0|-42.81|34.39|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||34.39|-42.81|0.8302
71646624|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.45|STANDARD_ERROR_OF_MEAN|19.581||0.559|TWO_SIDED|95.0|-50.01|27.1|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.10|-50.01|0.5590
71646625|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.84|STANDARD_ERROR_OF_MEAN|20.069||0.5558|TWO_SIDED|95.0|-51.36|27.69|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.69|-51.36|0.5558
71646626|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|20.332||0.6835|TWO_SIDED|95.0|-48.34|31.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||31.74|-48.34|0.6835
71646627|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.15|STANDARD_ERROR_OF_MEAN|19.601||0.5699|TWO_SIDED|95.0|-49.75|27.45|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.45|-49.75|0.5699
71646628|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.42|STANDARD_ERROR_OF_MEAN|19.918||0.3826|TWO_SIDED|95.0|-56.64|21.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||21.80|-56.64|0.3826
71646629|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.83|STANDARD_ERROR_OF_MEAN|20.069||0.5233|TWO_SIDED|95.0|-52.35|26.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.70|-52.35|0.5233
71646630|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.47|STANDARD_ERROR_OF_MEAN|20.332||0.3391|TWO_SIDED|95.0|-59.51|20.57|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.57|-59.51|0.3391
71646631|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.95|STANDARD_ERROR_OF_MEAN|19.601||0.3606|TWO_SIDED|95.0|-56.55|20.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||20.65|-56.55|0.3606
71646632|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.33|STANDARD_ERROR_OF_MEAN|19.918||0.5364|TWO_SIDED|95.0|-51.55|26.89|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||26.89|-51.55|0.5364
71646633|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.56|STANDARD_ERROR_OF_MEAN|20.069||0.5651|TWO_SIDED|95.0|-51.08|27.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||27.96|-51.08|0.5651
71646634|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.65|STANDARD_ERROR_OF_MEAN|20.332||0.4719|TWO_SIDED|95.0|-54.69|25.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||25.39|-54.69|0.4719
71646635|NCT01243151|142809665|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.53|STANDARD_ERROR_OF_MEAN|19.601||0.3999|TWO_SIDED|95.0|-55.13|22.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.||22.07|-55.13|0.3999
71824213|NCT02501811|143152042|SUPERIORITY||Mean Difference (Final Values)|-928.6|STANDARD_ERROR_OF_MEAN|754.2||0.009|TWO_SIDED|95.0|-2470.7|613.6|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||613.6|-2470.7|0.009
71646636|NCT03123874|142809698|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.827||||0.9|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial taxa in milk collected with own / sterile pump set-ups.|||||0.9
71646637|NCT03123874|142809699|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.163||||0.3|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean Shannon Diversity Index in milk collected with own / sterile pump set-ups|||||0.3
71646638|NCT03123874|142809700|OTHER|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first). Random effect was participant ID to account for multiple samples for each participant.|Mean Difference (Final Values)|4.95||||0.0003|TWO_SIDED|||||Results were considered statistically significant at p\<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial counts in milk collected with own / sterile pump set-ups.|||||0.0003
71646639|NCT04158687|142809717|SUPERIORITY||Least Square (LS) Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.8||0.6003|TWO_SIDED|95.0|-4.5|2.6|||Mixed model repeated measures (MMRM)|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.6|-4.5|0.6003
71646640|NCT04158687|142809717|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.8||0.392|TWO_SIDED|95.0|-2.0|5.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||5.0|-2.0|0.3920
71646641|NCT04158687|142809717|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.8||0.1444|TWO_SIDED|95.0|-0.9|6.0|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||6.0|-0.9|0.1444
71646642|NCT04158687|142809718|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8065|TWO_SIDED|95.0|-0.3|0.2|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.2|-0.3|0.8065
71646643|NCT04158687|142809718|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2121|TWO_SIDED|95.0|-0.1|0.4|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.4|-0.1|0.2121
71646644|NCT04158687|142809718|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0264|TWO_SIDED|95.0|0.0|0.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.5|0.0|0.0264
71646645|NCT04158687|142809719|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6101|TWO_SIDED|95.0|-2.1|3.5|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||3.5|-2.1|0.6101
71702433|NCT01482221|142921881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.37||0.821|TWO_SIDED|95.0|0.552|2.115||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.||2.115|0.552|0.821
71646646|NCT04158687|142809719|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6237|TWO_SIDED|95.0|-3.4|2.1|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||2.1|-3.4|0.6237
71646647|NCT04158687|142809719|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.4||0.1764|TWO_SIDED|95.0|-4.6|0.8|||MMRM|MMRM included fixed effects of treatment group, analysis visit, treatment-by-visit interaction, and a baseline-by-visit interaction.||||0.8|-4.6|0.1764
71646648|NCT00835666|142809753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|92.6|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|92.6|
71646649|NCT00835666|142809754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.2||||||90.0|94.7|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.7|
71646650|NCT00835666|142809755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.4||||||90.0|94.9|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.9|
71646651|NCT02312154|142809766|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71646652|NCT02312154|142809767|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71702434|NCT01482221|142921882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.318||0.751|TWO_SIDED|95.0|0.485|1.686|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.686|0.485|0.751
71646653|NCT02312154|142809768|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71646654|NCT02312154|142809769|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).||||<0.05
71646655|NCT02312154|142809770|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
71646656|NCT02312154|142809771|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse. Two independent investigators also individually assessed every patient's improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.||||<0.05
71646657|NCT01634139|142809775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.108|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.231|0.108|<0.0001
71646658|NCT01634139|142809775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.103|0.255|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.255|0.103|<0.0001
71646659|NCT01634139|142809776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.186|0.046|0.0012
71646660|NCT01634139|142809776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.188|0.048|0.0010
71646661|NCT01634139|142809776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.071|STANDARD_ERROR_OF_MEAN|0.036||0.0477|TWO_SIDED|95.0|0.001|0.142|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.142|0.001|0.0477
71646662|NCT01634139|142809776|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.036||0.0059|TWO_SIDED|95.0|0.029|0.17|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.170|0.029|0.0059
71646663|NCT01634139|142809777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.062|0.185|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.185|0.062|<0.0001
71824214|NCT02501811|143152042|SUPERIORITY||Mean Difference (Final Values)|-777.1|STANDARD_ERROR_OF_MEAN|756.5||0.661|TWO_SIDED|95.0|-2323.2|769.1|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||769.1|-2323.2|0.661
71646664|NCT01634139|142809777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.065|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.188|0.065|<0.0001
71646665|NCT01634139|142809778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.095|0.212|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.212|0.095|<0.0001
71646666|NCT01634139|142809778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.157|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.098|0.215|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.215|0.098|<0.0001
71646667|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.036||0.0012|TWO_SIDED|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.186|0.046|0.0012
71824215|NCT02501811|143152042|SUPERIORITY||Mean Difference (Final Values)|151.5|STANDARD_ERROR_OF_MEAN|162.2||0.015|TWO_SIDED|95.0|-175.4|478.4|||ANCOVA|Change in NT-proBNP value compared using ANCOVA analyses adjusting for baseline values. Data log transformed, p-values obtained from transformed data|Confidence intervals based on t test|||478.4|-175.4|0.015
71646668|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.036||0.001|TWO_SIDED|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose (Week 24)||0.188|0.048|0.0010
71886358|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.91|||<|0.0001|TWO_SIDED|95.0|2.46|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.21|2.46|<0.0001
71886359|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.45|6.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.22|2.45|<0.0001
71646669|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.076|0.201|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.201|0.076|<0.0001
71646670|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.151|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.088|0.213|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.213|0.088|<0.0001
71646671|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.211|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (Week 24)||0.211|0.084|<0.0001
71646672|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.084|0.21|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (Week 24)||0.210|0.084|<0.0001
71646673|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.101|0.226|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (Week 24)||0.226|0.101|<0.0001
71646674|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.106|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (Week 24)||0.231|0.106|<0.0001
71646675|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.116|0.24|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (Week 24)||0.240|0.116|<0.0001
71646676|NCT01634139|142809779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.114|0.238|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.238|0.114|<0.0001
71646677|NCT01634139|142809780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.038||0.0036|TWO_SIDED|95.0|0.036|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.184|0.036|0.0036
71646678|NCT01634139|142809780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.037||0.0152|TWO_SIDED|95.0|0.018|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.165|0.018|0.0152
71646679|NCT01634139|142809780|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0687|TWO_SIDED|95.0|-0.005|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.143|-0.005|0.0687
71646680|NCT01634139|142809780|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.038||0.1666|TWO_SIDED|95.0|-0.022|0.126|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.126|-0.022|0.1666
71646681|NCT01634139|142809781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.171|0.013|0.0228
71702435|NCT01482221|142921882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.315||0.555|TWO_SIDED|95.0|0.65|2.233|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.233|0.650|0.555
71886360|NCT00848354|143293291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.94|||<|0.0001|TWO_SIDED|95.0|3.13|7.78||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.78|3.13|<0.0001
71646682|NCT01634139|142809781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.131|-0.027|0.1980
71646683|NCT01634139|142809781|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.062|STANDARD_ERROR_OF_MEAN|0.04||0.1256|TWO_SIDED|95.0|-0.017|0.141|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.141|-0.017|0.1256
71646684|NCT01634139|142809781|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053|STANDARD_ERROR_OF_MEAN|0.04||0.188|TWO_SIDED|95.0|-0.026|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.026|0.1880
71646685|NCT01634139|142809782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.034||0.0023|TWO_SIDED|95.0|0.037|0.172|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.172|0.037|0.0023
71886361|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.19||||0.1086|TWO_SIDED|95.0|0.66|40.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||40.9|0.66|0.1086
71646686|NCT01634139|142809782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.034||0.0255|TWO_SIDED|95.0|0.009|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.143|0.009|0.0255
71646687|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.04||0.0228|TWO_SIDED|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)||0.171|0.013|0.0228
71702436|NCT01482221|142921883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.304||0.434|TWO_SIDED|95.0|0.699|2.301|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.301|0.699|0.434
71886362|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.0392|TWO_SIDED|95.0|1.04|12.3||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||12.3|1.04|0.0392
71886363|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.04|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||13.6|2.04|<0.0001
71886364|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.69|||<|0.0001|TWO_SIDED|95.0|2.39|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||13.6|2.39|<0.0001
71886365|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.02|7.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||7.09|2.02|<0.0001
71886366|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.02|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.60|2.02|<0.0001
71886367|NCT00848354|143293293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.36|7.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||7.46|2.36|<0.0001
71886368|NCT00848354|143293295|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71886369|NCT00848354|143293297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.23|||<|0.0001|TWO_SIDED|95.0|3.88|10.0||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||10.00|3.88|<0.0001
71886370|NCT00848354|143293298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.79|||<|0.0001|TWO_SIDED|95.0|3.49|17.39||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value.||17.39|3.49|<0.0001
71886371|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.24|5.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.46|2.24|<0.0001
71886372|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.91|8.55||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||8.55|2.91|<0.0001
71886373|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.93|12.02||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||12.02|2.93|<0.0001
71886374|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57|||<|0.0001|TWO_SIDED|95.0|2.27|9.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.21|2.27|<0.0001
71886375|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|2.74|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|2.74|<0.0001
71886376|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86|||<|0.0001|TWO_SIDED|95.0|3.0|15.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.72|3.00|<0.0001
71886377|NCT00848354|143293299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.64|||<|0.0001|TWO_SIDED|95.0|3.74|15.63||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.63|3.74|<0.0001
71886378|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||4.86|2.04|<0.0001
71886379|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.85|6.82||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.82|2.85|<0.0001
71702437|NCT01482221|142921883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.322||0.286|TWO_SIDED|95.0|0.377|1.334|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.334|0.377|0.286
71646688|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.04||0.198|TWO_SIDED|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose.(Week 24)||0.131|-0.027|0.1980
71646689|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.078|STANDARD_ERROR_OF_MEAN|0.037||0.0344|TWO_SIDED|95.0|0.006|0.15|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)||0.150|0.006|0.0344
71646690|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.037||0.0696|TWO_SIDED|95.0|-0.005|0.139|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)||0.139|-0.005|0.0696
71646691|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.109|STANDARD_ERROR_OF_MEAN|0.037||0.0032|TWO_SIDED|95.0|0.037|0.182|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (week 24)||0.182|0.037|0.0032
71646692|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.037||0.1044|TWO_SIDED|95.0|-0.012|0.132|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (week 24)||0.132|-0.012|0.1044
71646693|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.037||0.0027|TWO_SIDED|95.0|0.039|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (week 24)||0.186|0.039|0.0027
71646694|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.093|STANDARD_ERROR_OF_MEAN|0.037||0.013|TWO_SIDED|95.0|0.02|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (week 24)||0.166|0.020|0.0130
71646695|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025|TWO_SIDED|95.0|0.041|0.19|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (week 24)||0.190|0.041|0.0025
71646696|NCT01634139|142809783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.092|STANDARD_ERROR_OF_MEAN|0.038||0.0156|TWO_SIDED|95.0|0.017|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)||0.166|0.017|0.0156
71646697|NCT01634139|142809784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.165|STANDARD_ERROR_OF_MEAN|0.11||0.1349|TWO_SIDED|95.0|-0.382|0.051|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.051|-0.382|0.1349
71646698|NCT01634139|142809784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.209|STANDARD_ERROR_OF_MEAN|0.11||0.0588|TWO_SIDED|95.0|-0.425|0.008|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.008|-0.425|0.0588
71646699|NCT01634139|142809784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.154|STANDARD_ERROR_OF_MEAN|0.111||0.1675|TWO_SIDED|95.0|-0.372|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.065|-0.372|0.1675
71646700|NCT01634139|142809784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|0.111||0.0709|TWO_SIDED|95.0|-0.419|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.017|-0.419|0.0709
71646701|NCT01634139|142809785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.065||0.0749|TWO_SIDED|95.0|-0.245|0.012|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.012|-0.245|0.0749
71646702|NCT01634139|142809785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.065||0.0305|TWO_SIDED|95.0|-0.269|-0.013|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.013|-0.269|0.0305
71886380|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.5|6.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.38|2.50|<0.0001
71646703|NCT01634139|142809785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.125|STANDARD_ERROR_OF_MEAN|0.066||0.0581|TWO_SIDED|95.0|-0.255|0.004|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.004|-0.255|0.0581
71646704|NCT01634139|142809785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131|STANDARD_ERROR_OF_MEAN|0.066||0.0464|TWO_SIDED|95.0|-0.26|-0.002|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||-0.002|-0.260|0.0464
71646705|NCT01634139|142809786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096|STANDARD_ERROR_OF_MEAN|0.062||0.1182|TWO_SIDED|95.0|-0.217|0.025|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.025|-0.217|0.1182
71646706|NCT01634139|142809786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.126|STANDARD_ERROR_OF_MEAN|0.061||0.0404|TWO_SIDED|95.0|-0.246|-0.006|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.006|-0.246|0.0404
71646707|NCT01634139|142809786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.099|STANDARD_ERROR_OF_MEAN|0.062||0.1105|TWO_SIDED|95.0|-0.221|0.023|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.023|-0.221|0.1105
71646708|NCT01634139|142809786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.103|STANDARD_ERROR_OF_MEAN|0.062||0.0983|TWO_SIDED|95.0|-0.224|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.019|-0.224|0.0983
71646709|NCT01634139|142809787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.507|STANDARD_ERROR_OF_MEAN|5.387||0.1146|TWO_SIDED|95.0|-2.063|19.077|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||19.077|-2.063|0.1146
71646710|NCT01634139|142809787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.493|STANDARD_ERROR_OF_MEAN|5.365||0.1628|TWO_SIDED|95.0|-3.034|18.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||18.020|-3.034|0.1628
71646711|NCT01634139|142809787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.538|STANDARD_ERROR_OF_MEAN|5.435||0.3085|TWO_SIDED|95.0|-5.127|16.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||16.203|-5.127|0.3085
71646712|NCT01634139|142809787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.774|STANDARD_ERROR_OF_MEAN|5.413||0.1053|TWO_SIDED|95.0|-1.847|19.394|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||19.394|-1.847|0.1053
71646713|NCT01634139|142809788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.36|STANDARD_ERROR_OF_MEAN|5.451||0.0236|TWO_SIDED|95.0|1.663|23.056|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||23.056|1.663|0.0236
71646714|NCT01634139|142809788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.146|STANDARD_ERROR_OF_MEAN|5.427||0.0093|TWO_SIDED|95.0|3.497|24.794|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||24.794|3.497|0.0093
71646715|NCT01634139|142809788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.882|STANDARD_ERROR_OF_MEAN|5.497||0.7322|TWO_SIDED|95.0|-12.667|8.904|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||8.904|-12.667|0.7322
71646716|NCT01634139|142809788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.176|STANDARD_ERROR_OF_MEAN|5.481||0.4463|TWO_SIDED|95.0|-6.578|14.929|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||14.929|-6.578|0.4463
71646717|NCT01634139|142809789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.262|STANDARD_ERROR_OF_MEAN|1.039||0.8008|TWO_SIDED|95.0|-1.775|2.299|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||2.299|-1.775|0.8008
71646718|NCT01634139|142809789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|1.041||0.8731|TWO_SIDED|95.0|-1.875|2.208|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||2.208|-1.875|0.8731
71646719|NCT01634139|142809789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.058||0.7975|TWO_SIDED|95.0|-1.803|2.346|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||2.346|-1.803|0.7975
71646720|NCT01634139|142809789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.579|STANDARD_ERROR_OF_MEAN|1.059||0.5845|TWO_SIDED|95.0|-2.656|1.498|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||1.498|-2.656|0.5845
71646721|NCT01634139|142809790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.048||0.6932|TWO_SIDED|95.0|-0.075|0.113|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.113|-0.075|0.6932
71646722|NCT01634139|142809790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.048||0.1741|TWO_SIDED|95.0|-0.158|0.029|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.029|-0.158|0.1741
71646723|NCT01634139|142809790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.048||0.625|TWO_SIDED|95.0|-0.071|0.118|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.118|-0.071|0.6250
71646724|NCT01634139|142809790|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.048||0.7597|TWO_SIDED|95.0|-0.109|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.080|-0.109|0.7597
71646725|NCT01634139|142809791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.05||0.6166|TWO_SIDED|95.0|-0.122|0.073|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.073|-0.122|0.6166
71646726|NCT01634139|142809791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076|STANDARD_ERROR_OF_MEAN|0.049||0.1267|TWO_SIDED|95.0|-0.173|0.021|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.021|-0.173|0.1267
71646727|NCT01634139|142809791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0|-0.092|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.105|-0.092|0.9000
71646728|NCT01634139|142809791|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.05||0.3897|TWO_SIDED|95.0|-0.141|0.055|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.055|-0.141|0.3897
71646729|NCT01634139|142809792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.072||0.0975|TWO_SIDED|95.0|-0.262|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.022|-0.262|0.0975
71646730|NCT01634139|142809792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_ERROR_OF_MEAN|0.072||0.0116|TWO_SIDED|95.0|-0.323|-0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.041|-0.323|0.0116
71646731|NCT01634139|142809792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.073||0.3732|TWO_SIDED|95.0|-0.208|0.078|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.078|-0.208|0.3732
71646732|NCT01634139|142809792|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.073||0.1985|TWO_SIDED|95.0|-0.236|0.049|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.049|-0.236|0.1985
71646733|NCT01634139|142809794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.176|STANDARD_ERROR_OF_MEAN|0.072||0.0144|TWO_SIDED|95.0|0.035|0.316|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.316|0.035|0.0144
71646734|NCT01634139|142809794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.071||0.0747|TWO_SIDED|95.0|-0.013|0.267|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.267|-0.013|0.0747
71646735|NCT01634139|142809794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.072||0.7654|TWO_SIDED|95.0|-0.163|0.12|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.120|-0.163|0.7654
71646736|NCT01634139|142809794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.072||0.8082|TWO_SIDED|95.0|-0.124|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.158|-0.124|0.8082
71646737|NCT01634139|142809795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.085||0.0392|TWO_SIDED|95.0|0.009|0.341|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.341|0.009|0.0392
71646738|NCT01634139|142809795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.084||0.1351|TWO_SIDED|95.0|-0.039|0.292|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.292|-0.039|0.1351
71646739|NCT01634139|142809795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.085||0.8291|TWO_SIDED|95.0|-0.185|0.149|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.149|-0.185|0.8291
71646740|NCT01634139|142809795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.085||0.9655|TWO_SIDED|95.0|-0.163|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.171|-0.163|0.9655
71646741|NCT01634139|142809796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.191|STANDARD_ERROR_OF_MEAN|0.077||0.0139|TWO_SIDED|95.0|0.039|0.343|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.343|0.039|0.0139
71646742|NCT01634139|142809796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.077||0.1043|TWO_SIDED|95.0|-0.026|0.276|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.276|-0.026|0.1043
71646743|NCT01634139|142809796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.078||0.6547|TWO_SIDED|95.0|-0.118|0.187|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.187|-0.118|0.6547
71646744|NCT01634139|142809796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.077||0.3648|TWO_SIDED|95.0|-0.082|0.222|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.222|-0.082|0.3648
71646745|NCT01634139|142809797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.166|STANDARD_ERROR_OF_MEAN|0.074||0.0256|TWO_SIDED|95.0|0.02|0.312|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.312|0.020|0.0256
71646746|NCT01634139|142809797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.074||0.0561|TWO_SIDED|95.0|-0.004|0.286|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.286|-0.004|0.0561
71886381|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.37|6.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.41|2.37|<0.0001
71886382|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.19|9.76||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.76|3.19|<0.0001
71646747|NCT01634139|142809797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.075||0.4127|TWO_SIDED|95.0|-0.208|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.085|-0.208|0.4127
71646748|NCT01634139|142809797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.8922|TWO_SIDED|95.0|-0.136|0.156|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.156|-0.136|0.8922
71646749|NCT01634139|142809799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.7931|TWO_SIDED|95.0|-0.08|0.061|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.061|-0.080|0.7931
71646750|NCT01634139|142809799|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.036||0.0369|TWO_SIDED|95.0|-0.145|-0.005|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.005|-0.145|0.0369
71646751|NCT01634139|142809799|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.036||0.4086|TWO_SIDED|95.0|-0.101|0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.041|-0.101|0.4086
71646752|NCT01634139|142809799|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.036||0.4714|TWO_SIDED|95.0|-0.097|0.045|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.045|-0.097|0.4714
71646753|NCT01634139|142809800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.047||0.988|TWO_SIDED|95.0|-0.091|0.092|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.092|-0.091|0.9880
71646754|NCT01634139|142809800|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.082|STANDARD_ERROR_OF_MEAN|0.046||0.0794|TWO_SIDED|95.0|-0.173|0.01|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.010|-0.173|0.0794
71646755|NCT01634139|142809800|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.053|STANDARD_ERROR_OF_MEAN|0.047||0.2623|TWO_SIDED|95.0|-0.145|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.040|-0.145|0.2623
71646756|NCT01634139|142809800|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.047||0.3552|TWO_SIDED|95.0|-0.136|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.040|-0.136|0.3552
71646757|NCT01634139|142809801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.049||0.4359|TWO_SIDED|95.0|-0.135|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.058|-0.135|0.4359
71646758|NCT01634139|142809801|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.049||0.2293|TWO_SIDED|95.0|-0.155|0.037|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.037|-0.155|0.2293
71646759|NCT01634139|142809801|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8372|TWO_SIDED|95.0|-0.108|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.088|-0.108|0.8372
71646760|NCT01634139|142809801|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.049||0.3022|TWO_SIDED|95.0|-0.148|0.046|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.046|-0.148|0.3022
71646761|NCT01634139|142809802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.046||0.5004|TWO_SIDED|95.0|-0.122|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.060|-0.122|0.5004
71646762|NCT01634139|142809802|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.059|STANDARD_ERROR_OF_MEAN|0.046||0.1982|TWO_SIDED|95.0|-0.149|0.031|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.031|-0.149|0.1982
71646763|NCT01634139|142809802|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.8019|TWO_SIDED|95.0|-0.103|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.103|0.8019
71646764|NCT01634139|142809802|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.046||0.4872|TWO_SIDED|95.0|-0.123|0.059|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.059|-0.123|0.4872
71646765|NCT01634139|142809803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3498|TWO_SIDED|95.0|-0.135|0.048|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.048|-0.135|0.3498
71646766|NCT01634139|142809803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.046||0.0222|TWO_SIDED|95.0|-0.196|-0.015|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||-0.015|-0.196|0.0222
71646767|NCT01634139|142809803|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.047||0.799|TWO_SIDED|95.0|-0.104|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.080|-0.104|0.7990
71646768|NCT01634139|142809803|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.035|STANDARD_ERROR_OF_MEAN|0.047||0.4586|TWO_SIDED|95.0|-0.126|0.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.057|-0.126|0.4586
71646769|NCT01634139|142809804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.056||0.4221|TWO_SIDED|95.0|-0.156|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.065|-0.156|0.4221
71646770|NCT01634139|142809804|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093|STANDARD_ERROR_OF_MEAN|0.056||0.0959|TWO_SIDED|95.0|-0.204|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.017|-0.204|0.0959
71646771|NCT01634139|142809804|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.003|STANDARD_ERROR_OF_MEAN|0.057||0.9627|TWO_SIDED|95.0|-0.109|0.114|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.114|-0.109|0.9627
71646772|NCT01634139|142809804|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.057||0.3457|TWO_SIDED|95.0|-0.165|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.058|-0.165|0.3457
71646773|NCT01634139|142809805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.043||0.3375|TWO_SIDED|95.0|-0.043|0.125|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24||0.125|-0.043|0.3375
71646774|NCT01634139|142809805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.043||0.388|TWO_SIDED|95.0|-0.047|0.121|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24||0.121|-0.047|0.3880
71646775|NCT01634139|142809805|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.043||0.6541|TWO_SIDED|95.0|-0.066|0.104|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48||0.104|-0.066|0.6541
71646776|NCT01634139|142809805|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.043||0.5089|TWO_SIDED|95.0|-0.056|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48||0.133|-0.056|0.5089
71702438|NCT01482221|142921884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.382||0.357|TWO_SIDED|95.0|0.672|3.007|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||3.007|0.672|0.357
71702439|NCT01482221|142921884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.387||0.463|TWO_SIDED|95.0|0.622|2.84|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.840|0.622|0.463
71646777|NCT04442503|142809841|SUPERIORITY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.16||0.0007|TWO_SIDED|95.0|-6.3|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-6.3|0.0007
71646778|NCT04442503|142809842|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.999||0.0008|TWO_SIDED|95.0|-5.4|-1.4|||MMRM|||Change from Baseline at Day 3||-1.4|-5.4|0.0008
71646779|NCT04442503|142809842|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.244||0.0203|TWO_SIDED|95.0|-5.4|-0.5|||MMRM|||Change from Baseline at Day 28||-0.5|-5.4|0.0203
71886383|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|3.16|9.52||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||9.52|3.16|<0.0001
71886384|NCT00848354|143293301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.87|11.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.21|3.87|<0.0001
71886385|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.3|5.4||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.40|2.30|<0.0001
71886386|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|||<|0.0001|TWO_SIDED|95.0|3.07|7.71||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.71|3.07|<0.0001
71886387|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001|TWO_SIDED|95.0|2.98|8.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.41|2.98|<0.0001
71886388|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.55|7.58||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||7.58|2.55|<0.0001
71886389|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.81|||<|0.0001|TWO_SIDED|95.0|3.15|10.74||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.74|3.15|<0.0001
71886390|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.0001|TWO_SIDED|95.0|3.25|11.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||11.73|3.25|<0.0001
71886391|NCT00848354|143293303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.45|||<|0.0001|TWO_SIDED|95.0|3.67|11.33||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.33|3.67|<0.0001
71886392|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.09||||0.0349|TWO_SIDED|95.0|1.05|9.13||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||9.13|1.05|0.0349
71886393|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|||<|0.0001|TWO_SIDED|95.0|1.98|7.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.60|1.98|<0.0001
71886394|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.1|5.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.88|2.10|<0.0001
71886395|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.0001|TWO_SIDED|95.0|2.02|5.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.06|2.02|<0.0001
71886396|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.78|6.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||6.96|2.78|<0.0001
71886397|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|6.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.90|2.80|<0.0001
71886398|NCT00848354|143293305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.13|||<|0.0001|TWO_SIDED|95.0|3.82|9.85||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.85|3.82|<0.0001
71646780|NCT04442503|142809842|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.277||0.0067|TWO_SIDED|95.0|-6.0|-1.0|||MMRM|||Change from Baseline at Day 45||-1.0|-6.0|0.0067
71646781|NCT04442503|142809843|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.196||0.0052|TWO_SIDED|95.0|-0.9|-0.2|||MMRM|||Change from Baseline at Day 15||-0.2|-0.9|0.0052
71886399|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.25|||<|0.0001|TWO_SIDED|95.0|2.74|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||6.60|2.74|<0.0001
71646782|NCT04442503|142809844|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0209|TWO_SIDED|95.0|1.112|3.67||P-value are from a generalized estimating equation (GEE) for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.670|1.112|0.0209
71646783|NCT04442503|142809844|SUPERIORITY||Odds Ratio (OR)|1.534||||0.1661|TWO_SIDED|95.0|0.837|2.812||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||2.812|0.837|0.1661
71646784|NCT04442503|142809845|SUPERIORITY||Odds Ratio (OR)|1.781||||0.111|TWO_SIDED|95.0|0.876|3.621||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 15||3.621|0.876|0.1110
71646785|NCT04442503|142809845|SUPERIORITY||Odds Ratio (OR)|2.083||||0.0226|TWO_SIDED|95.0|1.108|3.915||P-value are from a GEE for binary response model, with factors for treatment, baseline HAMD-17 total score, baseline antidepressant use, assessment time point, and time-point-by treatment interaction.|GEE Model|||Day 45||3.915|1.108|0.0226
71646786|NCT04442503|142809846|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0089|TWO_SIDED|95.0|1.223|4.072|||MMRM|||Day 15||4.072|1.223|0.0089
71646787|NCT04442503|142809847|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.98||0.0235|TWO_SIDED|95.0|-4.2|-0.3|||MMRM|||Change from Baseline at Day 15||-0.3|-4.2|0.0235
71646788|NCT04442503|142809848|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.706||0.0034|TWO_SIDED|95.0|-8.4|-1.7|||MMRM|||Change from Baseline at Day 15||-1.7|-8.4|0.0034
71646789|NCT04442503|142809849|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.4||0.0151|TWO_SIDED|95.0|-10.6|-1.2|||MMRM|||Change from Baseline in Core Subscale at Day 15||-1.2|-10.6|0.0151
71646790|NCT04442503|142809849|SUPERIORITY||LS Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|2.27||0.0123|TWO_SIDED|95.0|-10.2|-1.3|||MMRM|||Change from Baseline in Anxiety Subscale at Day 15||-1.3|-10.2|0.0123
71646791|NCT04442503|142809849|SUPERIORITY||LS Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|2.96||0.004|TWO_SIDED|95.0|-14.5|-2.8|||MMRM|||Change from Baseline in Bech-6 Subscale at Day 15||-2.8|-14.5|0.0040
71646792|NCT04442503|142809849|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.609||0.0041|TWO_SIDED|95.0|-12.7|-2.4|||MMRM|||Change from Baseline in Meier Subscale at Day 15||-2.4|-12.7|0.0041
71646793|NCT04442503|142809851|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.649||0.6912|TWO_SIDED|95.0|-1.0|1.5|||MMRM|||Change from Baseline at Day 3||1.5|-1.0|0.6912
71646794|NCT04442503|142809851|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.874||0.041|TWO_SIDED|95.0|-3.5|-0.1|||MMRM|||Change from Baseline at Day 8||-0.1|-3.5|0.0410
71646795|NCT04442503|142809851|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.922||0.0444|TWO_SIDED|95.0|-3.7|0.0|||MMRM|||Change from Baseline at Day 15||0.0|-3.7|0.0444
71646796|NCT04442503|142809851|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.924||0.0811|TWO_SIDED|95.0|-3.4|0.2|||MMRM|||Change from Baseline at Day 21||0.2|-3.4|0.0811
71646797|NCT04442503|142809851|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.987||0.1846|TWO_SIDED|95.0|-3.3|0.6|||MMRM|||Change from Baseline at Day 28||0.6|-3.3|0.1846
71646798|NCT04442503|142809851|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.031||0.0625|TWO_SIDED|95.0|-4.0|0.1|||MMRM|||Change from Baseline at Day 45||0.1|-4.0|0.0625
71646799|NCT01945580|142809866|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 362 subjects (181 subjects per arm) are needed to detect non-inferiority of transvaginal biologic to native tissue repair, using a margin of 12.0%.|Adjusted Difference in Percentages|0.2|||||TWO_SIDED|90.0|-5.6|5.9|||||The propensity adjusted treatment difference of Xenform transvaginal mesh (TVM) minus NTR was estimated and missing data was handled using multiple imputation method.|||5.9|-5.6|
71646800|NCT01945580|142809867|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.10 (power 90%), 308 subjects (154 subjects per arm) are needed to detect non-inferiority with a margin of 11.6%.|Adjusted Difference in Percentages|2.0|||||TWO_SIDED|90.0|-0.8|4.7|||||The propensity score adjusted difference in SAE rate of Xenform transvaginal mesh (TVM) vs. NTR was estimated.|||4.7|-0.8|
71646801|NCT00989950|142809908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|14.0||0.588|TWO_SIDED|95.0|0.0|233.0|||ANOVA|||||233|0|0.588
71646802|NCT00101439|142809909|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|0.89||||0.241|TWO_SIDED|95.0|0.73|1.08||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.08|0.73|0.241
71646803|NCT00101439|142809910|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.02||||0.812|TWO_SIDED|95.0|0.87|1.2||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo|||1.20|0.87|0.812
71646804|NCT00840658|142809924|SUPERIORITY|||||||0.036|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)|To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.036
71646805|NCT00840658|142809925|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)|We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit\*Group interaction, with our primary interest in the Visit\*Group interaction, as a significant p-value would be indicative of an intervention effect.|||0.013
71660960|NCT03118570|142835405|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.563||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.563
71646806|NCT00474058|142809926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55||||0.0002||95.0|-5.37|-1.73||No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-1.73|-5.37|0.0002
71646807|NCT00474058|142809927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26|||<|0.0001||95.0|-6.08|-2.45||No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-2.45|-6.08|<0.0001
71646808|NCT00474058|142809928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0301||95.0|-0.79|-0.04|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||-0.04|-0.79|0.0301
71646809|NCT00474058|142809929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8842||95.0|-0.29|0.25|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.||0.25|-0.29|0.8842
71646810|NCT03306277|142809950|SUPERIORITY||||||<|0.0001|||||||One-sided Exact Binomial Test|||This comparison is made to an assumed rate of zero 0 (or as low as 0.1%). By definition, children with spinal muscular atrophy Type 1 are never able to sit independently.||||<0.0001
71646811|NCT03306277|142809951|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||This comparison is made against the results from the age and gender-matched control participants selected from existing natural history data sets (PNCR) \[Neurol. 2014; 83(9):810-817\].|Data for the current study were compared to historical control data (Finkel et al,2014 - PubMed 25080519) where event-free survival was 6 out of 23 participants (26.1%) at 14 months of age.|||<0.0001
71646812|NCT01296841|142809956|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|We performed t-test statistics for univariate comparisons for continuous variables.||||||<0.05
71646813|NCT01852799|142809964|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||bALP changes from baseline to cycle 1||||0.002
71646814|NCT01852799|142809964|OTHER||||||<|0.001|||||||t-test, 2 sided|||b-ALP changes from baseline to cycle 4||||<0.001
71646815|NCT01852799|142809964|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||DKK-1 changes from baseline to cycle 1||||0.005
71646816|NCT01852799|142809964|OTHER||||||<|0.001|||||||t-test, 2 sided|||DKK-1 changes from baseline to cycle 4||||<0.001
71886400|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.94|7.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.18|2.94|<0.0001
71886401|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.0001|TWO_SIDED|95.0|3.15|8.61||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.61|3.15|<0.0001
71646817|NCT00672984|142809998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43||||||90.0|-4.52|-0.34||||||||-0.34|-4.52|
71646818|NCT00672984|142809998|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.87||||||90.0|11.45|16.29||||||||16.29|11.45|
71646819|NCT00672984|142809999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.08||||||90.0|-11.37|-4.78||||||||-4.78|-11.37|
71646820|NCT00672984|142809999|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.13||||||90.0|9.33|16.93||||||||16.93|9.33|
71646821|NCT00672984|142810000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||||90.0|-1.07|3.03||||||||3.03|-1.07|
71646822|NCT00672984|142810000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.11||||||90.0|8.97|13.24||||||||13.24|8.97|
71646823|NCT00672984|142810001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64||||||90.0|-0.99|4.27||||||||4.27|-0.99|
71646824|NCT00672984|142810001|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8||||||90.0|7.63|13.97||||||||13.97|7.63|
71646825|NCT00672984|142810002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.76||||||90.0|-8.01|-5.51||||||||-5.51|-8.01|
71646826|NCT00672984|142810002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73||||||90.0|3.08|6.38||||||||6.38|3.08|
71646827|NCT00672984|142810003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.85||||||90.0|-21.92|-17.78||||||||-17.78|-21.92|
71646828|NCT00672984|142810003|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44||||||90.0|1.77|5.11||||||||5.11|1.77|
71646829|NCT00672984|142810004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.32||||||90.0|11.75|18.89||||||||18.89|11.75|
71646830|NCT00672984|142810004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||||90.0|-2.77|4.63||||||||4.63|-2.77|
71646831|NCT00672984|142810005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|49.85||||||90.0|44.71|54.98||||||||54.98|44.71|
71646832|NCT00672984|142810005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.63||||||90.0|-0.41|7.66||||||||7.66|-0.41|
71660961|NCT03118570|142835405|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.839||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.839
71660962|NCT03118570|142835405|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.186||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.186
71646833|NCT00985751|142810038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
71646834|NCT00985751|142810039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature \> 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature \>40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express|Difference in percentage|0.97|||||TWO_SIDED|95.0|-6.1|5.32||||||Fever \>40°C-non-inferiority: To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever \> 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.||5.32|-6.1|
71646835|NCT00380588|142810051|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||P-value for response (Complete Response + Partial Response).|Fisher Exact|||||||0.380
71646836|NCT00380588|142810052|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Log Rank|||||||0.074
71886402|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.77|||<|0.0001|TWO_SIDED|95.0|3.36|9.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||9.93|3.36|<0.0001
71646837|NCT00380588|142810053|SUPERIORITY_OR_OTHER|||||||0.136||95.0|||||Log Rank|||||||0.136
71646838|NCT01120028|142810084|OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.64|||Log Rank|||||0.64|0.28|<0.0001
71646839|NCT01120028|142810085|OTHER|||||||0.5|||||||ANCOVA|||||||0.5
71646840|NCT01120028|142810086|OTHER||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.59|2.55|||Regression, Cox|||||2.55|0.59|0.58
71646841|NCT01120028|142810087|OTHER||Rate Ratio|1.99||||0.23|TWO_SIDED|95.0|0.64|6.18|||Log Rank|||||6.18|0.64|0.23
71646842|NCT01120028|142810088|OTHER||Rate Ratio|1.02||||0.88|TWO_SIDED|95.0|0.8|1.29|||Regression, Cox|||||1.29|0.80|0.88
71646843|NCT01120028|142810089|OTHER||Rate ratio|1.51||||0.008|TWO_SIDED|95.0|1.11|2.06|||Log Rank|||||2.06|1.11|0.008
71646844|NCT01120028|142810090|OTHER||Rate Ratio|1.0||||0.99|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.99
71646845|NCT01120028|142810091|OTHER||Rate Ratio|0.76||||0.52|TWO_SIDED|95.0|0.34|1.73|||Log Rank|||||1.73|0.34|0.52
71646846|NCT03867760|142810092|SUPERIORITY|The study was designed to detect a difference in pain intensity of at least 0.85 points corresponding to an effect size of 0.57 based on results from our pilot study. The sample size needed was 50 per group based on power of .80, alpha of .05.||||||0.809||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain intensity than cancer survivors assigned to the relaxation intervention.||||0.809
71646847|NCT03867760|142810093|SUPERIORITY|||||||0.369||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in addition to baseline pain medications in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in pain interference than cancer survivors assigned to the relaxation intervention.||||0.369
71646848|NCT03867760|142810094|SUPERIORITY|||||||0.029||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in anxiety than cancer survivors assigned to the relaxation intervention.||||0.029
71646849|NCT03867760|142810095|SUPERIORITY|||||||0.236||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in depression than cancer survivors assigned to the relaxation intervention.||||0.236
71646850|NCT03867760|142810096|SUPERIORITY|||||||0.904||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in fatigue than cancer survivors assigned to the relaxation intervention.||||0.904
71646851|NCT03867760|142810097|SUPERIORITY|||||||0.936||||||An a priori significance level was set at 0.05.|ANCOVA|We controlled for pre-treatment scores in the ANCOVA analysis.||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention for 28 days will not report significantly greater pre- to post-treatment decreases in sleep disturbance than cancer survivors assigned to the relaxation intervention.||||0.936
71646852|NCT03867760|142810098|SUPERIORITY|||||||0.02||||||An a priori significance level was set at 0.05.|t-test, 2 sided|||Null Hypothesis: Cancer survivors with chronic pain assigned to the daily use of the hypnosis intervention who experience a clinically meaningful improvement in pain intensity will not have a significantly higher pre-treatment treatment credibility and expectancy score than non-improvers.||||0.02
71646853|NCT02286466|142810106|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.38||0.412|TWO_SIDED|95.0|-1.6|3.87||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcomes and psychotropic medication use||Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||3.87|-1.60|0.412
71646854|NCT02286466|142810107|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|2.51||0.997|TWO_SIDED|95.0|-4.99|4.96||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use||4.96|-4.99|0.997
71646855|NCT02286466|142810108|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.63||0.215|TWO_SIDED|95.0|-0.46|2.02||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||2.02|-0.46|0.215
71646856|NCT02286466|142810108|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.379|TWO_SIDED|95.0|-0.6|1.57||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.57|-0.60|0.379
71646857|NCT02286466|142810109|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.81||0.852|TWO_SIDED|95.0|-1.45|1.75||a priori threshold p\<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.||1.75|-1.45|0.852
71646858|NCT02153645|142810110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.9||0.179|TWO_SIDED|95.0|-13.9|2.6|||ANCOVA|||||2.6|-13.9|0.179
71646859|NCT02153645|142810110|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.95||0.458|TWO_SIDED|95.0|-11.2|5.1|||ANCOVA|||||5.1|-11.2|0.458
71646860|NCT00840879|142810147|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.15||||||90.0|90.96|105.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.90|90.96|
71646861|NCT00840879|142810148|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.34||||||90.0|91.82|101.07|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.07|91.82|
71646862|NCT00840879|142810149|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.76||||||90.0|93.31|102.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.42|93.31|
71646863|NCT00840840|142810150|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.45||||||90.0|97.71|105.33|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.33|97.71|
71646864|NCT00840840|142810151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|103.05||||||90.0|101.25|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.88|101.25|
71646865|NCT00840840|142810152|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|102.94||||||90.0|101.08|104.83|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.83|101.08|
71646866|NCT00840840|142810153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|99.68||||||90.0|92.41|107.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||107.52|92.41|
71646867|NCT00840840|142810154|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|101.48||||||90.0|94.73|108.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.71|94.73|
71646868|NCT00840840|142810155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA|Test/Reference Ratio of the mean x 100|100.17||||||90.0|91.95|109.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.13|91.95|
71646869|NCT03247686|142810179|SUPERIORITY|||||||4.96e-05|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 All||||0.0000496
71646870|NCT03247686|142810179|SUPERIORITY|||||||1.03e-05|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 All||||0.0000103
71646871|NCT03247686|142810179|SUPERIORITY|||||||0.0004398|||||||t-test, 2 sided|||Module M5.12 Placebo versus RSLV-132 All||||0.0004398
71646872|NCT03247686|142810179|SUPERIORITY|||||||6.8e-06|||||||t-test, 2 sided|||Module 1.2 Placebo versus RSLV-132 Responders||||0.0000068
71646873|NCT03247686|142810179|SUPERIORITY|||||||2e-07|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Responders||||0.0000002
71646874|NCT03247686|142810179|SUPERIORITY|||||||9.26e-05|||||||t-test, 2 sided|||Module 5.12 Placebo versus RSLV-132 Responders||||0.0000926
71646875|NCT03247686|142810179|SUPERIORITY|||||||0.001545|||||||t-test, 2 sided|||Module M1.2 Placebo versus RSLV-132 Non-responders||||0.0015450
71646876|NCT03247686|142810179|SUPERIORITY|||||||0.0004632|||||||t-test, 2 sided|||Module M3.4 Placebo versus RSLV-132 Non-responders||||0.0004632
71646877|NCT03247686|142810179|SUPERIORITY|||||||0.009696|||||||t-test, 2 sided|||Module M5.12||||0.0096960
71646878|NCT03247686|142810180|EQUIVALENCE|Two sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-2.5||||0.18|TWO_SIDED|95.0|-6.34|1.34|||t-test, 2 sided|||Mean difference in change from baseline (95% CI)||1.34|-6.34|0.180
71646879|NCT02583048|142810192|SUPERIORITY||Mean Difference (Net)|8.4|||||TWO_SIDED|95.1|2.0|14.8|||||Arm 3 minus Arm 1 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||14.8|2.0|
71646880|NCT02583048|142810192|SUPERIORITY||Mean Difference (Net)|12.1|||||TWO_SIDED|95.1|5.7|18.6|||||Arm 3 minus Arm 2 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|||18.6|5.7|
71646881|NCT02583048|142810199|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.117|||||TWO_SIDED|90.0|0.884|1.411|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.411|0.884|
71646882|NCT02583048|142810199|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.989|1.461|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.461|0.989|
71646883|NCT02583048|142810199|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.958|||||TWO_SIDED|90.0|0.774|1.187|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.187|0.774|
71646884|NCT02583048|142810200|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.986|||||TWO_SIDED|90.0|0.801|1.215|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.215|0.801|
71646885|NCT02583048|142810200|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.978|||||TWO_SIDED|90.0|0.764|1.251|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.251|0.764|
71646886|NCT02583048|142810200|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.859|||||TWO_SIDED|90.0|0.667|1.108|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.108|0.667|
71646887|NCT02583048|142810201|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.036|||||TWO_SIDED|90.0|0.847|1.267|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.267|0.847|
71646888|NCT02583048|142810201|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.037|||||TWO_SIDED|90.0|0.843|1.276|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.276|0.843|
71646889|NCT02583048|142810201|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.915|||||TWO_SIDED|90.0|0.727|1.151|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.151|0.727|
71646890|NCT02583048|142810202|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.043|||||TWO_SIDED|90.0|0.864|1.258|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.258|0.864|
71646891|NCT02583048|142810202|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.029|||||TWO_SIDED|90.0|0.858|1.235|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.235|0.858|
71646892|NCT02583048|142810202|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.657|0.993|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.993|0.657|
71646893|NCT02583048|142810203|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.068|||||TWO_SIDED|90.0|0.903|1.263|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.263|0.903|
71646894|NCT02583048|142810203|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.973|||||TWO_SIDED|90.0|0.82|1.155|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.155|0.820|
71646895|NCT02583048|142810203|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.803|||||TWO_SIDED|90.0|0.656|0.983|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||0.983|0.656|
71646896|NCT02583048|142810204|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.049|||||TWO_SIDED|90.0|0.881|1.248|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 2.||1.248|0.881|
71646897|NCT02583048|142810204|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.979|||||TWO_SIDED|90.0|0.823|1.165|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 8.||1.165|0.823|
71646898|NCT02583048|142810204|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.808|||||TWO_SIDED|90.0|0.638|1.025|||||The numerator represents Arm 3 and the denominator represents Arm 1.|Statistical analysis for Week 24.||1.025|0.638|
71646899|NCT02583048|142810205|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.903|||||TWO_SIDED|90.0|0.778|1.049|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.049|0.778|
71646900|NCT02583048|142810205|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.114|||||TWO_SIDED|90.0|0.944|1.315|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.315|0.944|
71646901|NCT02583048|142810205|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.804|||||TWO_SIDED|90.0|0.639|1.012|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.012|0.639|
71646902|NCT02583048|142810206|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.937|||||TWO_SIDED|90.0|0.81|1.084|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.084|0.810|
71646903|NCT02583048|142810206|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.107|||||TWO_SIDED|90.0|0.929|1.318|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.318|0.929|
71646904|NCT02583048|142810206|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.856|||||TWO_SIDED|90.0|0.703|1.043|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.043|0.703|
71646905|NCT02583048|142810207|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.951|||||TWO_SIDED|90.0|0.825|1.096|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.096|0.825|
71646906|NCT02583048|142810207|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.136|||||TWO_SIDED|90.0|0.948|1.362|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.362|0.948|
71646907|NCT02583048|142810207|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.727|1.109|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.109|0.727|
71646908|NCT02583048|142810208|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.939|||||TWO_SIDED|90.0|0.806|1.094|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.094|0.806|
71646909|NCT02583048|142810208|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.081|||||TWO_SIDED|90.0|0.864|1.352|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.352|0.864|
71646910|NCT02583048|142810208|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.597|1.253|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.253|0.597|
71646911|NCT02583048|142810209|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.825|1.095|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.095|0.825|
71646912|NCT02583048|142810209|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.862|1.354|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.354|0.862|
71646913|NCT02583048|142810209|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.865|||||TWO_SIDED|90.0|0.605|1.239|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.239|0.605|
71646914|NCT02583048|142810210|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.851|1.138|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 2.||1.138|0.851|
71646915|NCT02583048|142810210|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|1.086|||||TWO_SIDED|90.0|0.866|1.361|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 8.||1.361|0.866|
71646916|NCT02583048|142810210|EQUIVALENCE|GMRs were compared to no effect boundaries of 0.67 to 1.50.|Geometric Mean Ratio|0.927|||||TWO_SIDED|90.0|0.65|1.322|||||The numerator represents Arm 3 and the denominator represents Arm 2.|Statistical analysis for Week 24.||1.322|0.650|
71646917|NCT01851876|142810215|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||||||0.025
71646918|NCT02578641|142810249|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.1942|TWO_SIDED|95.0|0.91|1.56||Between-treatment comparisons were assessed using stratified log-rank test stratified by country and disease stage per randomization stratification.|Log Rank|Log-rank test of Hazards Ration equals 1, using Cox proportional hazards regression.|Hazard ratios were estimated using Cox proportional hazards regression.|||1.56|0.91|0.1942
71646919|NCT01710358|142810266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|||||||0.001
71646920|NCT01456962|142810318|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
71646921|NCT01456962|142810318|SUPERIORITY_OR_OTHER||% change in CD4+:CD8+ T cells ratio|-9.5||||0.4|TWO_SIDED|95.0|-27.3|12.0|||Regression, Linear|Adjusted for treatment group and time on antiretroviral therapy|Change based on a 1 log unit increase in genital:plasma drug ratio|Null hypothesis: Higher genital to plasma antiretroviral drug ratios are not associated with higher cervical CD4+:CD8+ T cell ratios.||12|-27.3|0.4
71646922|NCT01167829|142810358|SUPERIORITY_OR_OTHER||Mean Difference (Net)|183.0|STANDARD_ERROR_OF_MEAN|44.0||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
71646923|NCT02704091|142810374|SUPERIORITY|"The following Null-hypothesis was tested:~H0: λA(t) = λB (t) versus H1: λA(t) ≠ λB (t), where λ(t) represents the hazard at time t, A=diosmectite and B=placebo."|||||=|0.2524|||||||Wilcoxon-Gehan test|||The primary analysis tested the equality of time to recovery between the 2 treatment groups, applying the 2-sided Gehan-Wilcoxon test (α=5%).||||=0.2524
71646924|NCT02704091|142810375|SUPERIORITY||||||=|0.3511|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to recovery, analysed using the Gehan-Wilcoxon test.||||=0.3511
71646925|NCT02704091|142810376|SUPERIORITY||||||=|0.7285|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to first formed stool, analysed using the Gehan-Wilcoxon test.||||=0.7285
71646926|NCT02704091|142810377|SUPERIORITY||||||=|0.1807|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from first study treatment intake to last watery stool, analysed using the Gehan-Wilcoxon test.||||=0.1807
71646927|NCT02704091|142810378|SUPERIORITY||Least Squares (LS) Mean Difference|-0.04||||0.4294|TWO_SIDED|95.0|-0.15|0.07|||ANCOVA|||Comparison between the 2 treatment groups for number of stools for the overall time period, based on an analysis of covariance (ANCOVA) method for repeated measurements. The model included the number of stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||0.07|-0.15|0.4294
71646928|NCT02704091|142810379|SUPERIORITY||LS Mean Difference|-0.12||||0.0465|TWO_SIDED|95.0|-0.24|0.0|||ANCOVA|||Comparison between the 2 treatment groups for number of watery stools for the overall time period, based on an ANCOVA method for repeated measurements. The model included the number of watery stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.||-0.00|-0.24|0.0465
71646929|NCT03068780|142810407|SUPERIORITY||Odds Ratio (OR)|1.84||||0.013|TWO_SIDED|95.0|1.02|3.3||P-value adjusted with CHW method using CMH test statistics based on a test stratified by EB subtype and target wound size class estimated separately before and after the interim analysis for sample size re-estimation.Threshold of superiority p\<0.05.|Cui, Hung, Wang (CHW) approach|Primary efficacy endpoint was first assessed with the CMH test, but the final statistical analysis was performed based on the CHW approach.|The CMH test statistic from the data until the interim analysis (IA) and the CMH test statistic of the data after the IA must be calculated separately. The results are then combined using the CHW weighted approach to one test-statistic.|||3.30|1.02|0.013
71646930|NCT03068780|142810408|SUPERIORITY|||||||0.302||||||Threshold of superiority is p\<0.05|Chi-squared|||||||0.302
71702440|NCT01482221|142921885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.342||0.911|TWO_SIDED|95.0|0.532|2.031|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||2.031|0.532|0.911
71886403|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|3.91|13.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.09|3.91|<0.0001
71824216|NCT02501811|143152043|OTHER||slope of time|0.267|STANDARD_ERROR_OF_MEAN|0.241||0.269|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported||||0.269
71646931|NCT02426918|142810442|NON_INFERIORITY|Non-inferiority for the low dose was confirmed if the upper bound of the CI was \< 15% and if non-inferiority was confirmed for the high dose.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-11.42|3.0||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||3.00|-11.42|
71646932|NCT02426918|142810442|NON_INFERIORITY|Non-inferiority for the high dose was confirmed if the upper bound of the CI was \< 15%.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-8.32|8.38||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \[cellulitis, noncellulitis\] according to a Mantel-Haenszel type risk difference estimator.||8.38|-8.32|
71646933|NCT02420353|142810482|OTHER|||||||0.0498|||||||Mixed Models Analysis|||Mixed effect model||||0.0498
71646934|NCT02420353|142810483|OTHER|Mixed effects model||||||0.7024|||||||Mixed Models Analysis|||||||0.7024
71646935|NCT02420353|142810484|OTHER|Mixed effects model||||||0.135|||||||Mixed Models Analysis|||||||0.135
71646936|NCT02420353|142810485|OTHER|Mixed effects model||||||0.6836|||||||Mixed Models Analysis|||||||0.6836
71646937|NCT02420353|142810486|OTHER|mixed effects model||||||0.9271|||||||Mixed Models Analysis|||||||0.9271
71646938|NCT02420353|142810487|OTHER|mixed effects model||||||0.1576|||||||Mixed Models Analysis|||||||0.1576
71646939|NCT02420353|142810488|OTHER|mixed effects model||||||0.5586|||||||Mixed Models Analysis|||||||0.5586
71646940|NCT02420353|142810489|OTHER|mixed effects model||||||0.45|||||||Mixed Models Analysis|||||||0.45
71646941|NCT02420353|142810490|OTHER|mixed effects model||||||0.8573|||||||Mixed Models Analysis|||||||0.8573
71646942|NCT02420353|142810491|OTHER|mixed effects model||||||0.0564|||||||Mixed Models Analysis|||||||0.0564
71646943|NCT02420353|142810492|OTHER|mixed effects model||||||0.7883|||||||Mixed Models Analysis|||||||0.7883
71646944|NCT02420353|142810493|OTHER|mixed effects model||||||0.0901|||||||Mixed Models Analysis|||||||0.0901
71646945|NCT02420353|142810494|OTHER|mixed effects model||||||0.6292|||||||Mixed Models Analysis|||||||0.6292
71646946|NCT02420353|142810495|OTHER|mixed effects model||||||0.161|||||||Mixed Models Analysis|||||||0.161
71702441|NCT01482221|142921885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.368||0.509|TWO_SIDED|95.0|0.382|1.613|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.||1.613|0.382|0.509
71646947|NCT02420353|142810496|OTHER|mixed effects model||||||0.4437|||||||Mixed Models Analysis|||||||0.4437
71646948|NCT02420353|142810497|OTHER|mixed effects model||||||0.7325|||||||Mixed Models Analysis|||||||0.7325
71646949|NCT02420353|142810498|OTHER|Mixed effects analysis||||||0.6291|||||||Mixed Models Analysis|||||||0.6291
71646950|NCT02420353|142810499|OTHER|Mixed-effects model||||||0.3332|||||||Mixed Models Analysis|||||||0.3332
71646951|NCT02420353|142810500|OTHER|Mixed effects analysis||||||0.79|||||||Mixed Models Analysis|||||||0.79
71646952|NCT02420353|142810501|OTHER|Mixed effects analysis||||||0.4965|||||||Mixed Models Analysis|||||||0.4965
71646953|NCT02420353|142810502|OTHER|mixed effects analysis||||||0.1331|||||||Mixed Models Analysis|||||||0.1331
71646954|NCT02420353|142810503|OTHER|Mixed-model analysis||||||0.5251|||||||Mixed Models Analysis|||||||0.5251
71646955|NCT02420353|142810504|OTHER|Mixed effects analysis||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
71646956|NCT02420353|142810505|OTHER|Mixed effects analysis||||||0.4852|||||||Mixed Models Analysis|||||||0.4852
71646957|NCT02420353|142810506|OTHER|||||||0.7943|||||||Mixed Models Analysis|||||||0.7943
71646958|NCT02420353|142810507|OTHER|||||||0.0894|||||||Mixed Models Analysis|||||||0.0894
71646959|NCT02420353|142810508|OTHER|Mixed effects analysis||||||0.0673|||||||Mixed Models Analysis|||||||0.0673
71646960|NCT02420353|142810509|OTHER|Mixed effects analysis||||||0.0185|||||||Mixed Models Analysis|||||||0.0185
71646961|NCT02420353|142810510|OTHER|mixed effects analysis||||||0.6094|||||||Mixed Models Analysis|||||||0.6094
71646962|NCT02420353|142810511|OTHER|mixed effects analysis||||||0.3279|||||||Mixed Models Analysis|||||||0.3279
71646963|NCT02420353|142810512|OTHER|mixed effects analysis||||||0.2802|||||||Mixed Models Analysis|||||||0.2802
71646964|NCT02420353|142810513|OTHER|||||||0.1064|||||||Mixed Models Analysis|||||||0.1064
71646965|NCT02420353|142810514|OTHER|mixed effects model||||||0.0509|||||||Mixed Models Analysis|||||||0.0509
71646966|NCT02420353|142810515|OTHER|mixed effects analysis||||||0.1605|||||||Mixed Models Analysis|||||||0.1605
71646967|NCT02420353|142810516|OTHER|mixed effects model||||||0.0357|||||||Mixed Models Analysis|||||||0.0357
71646968|NCT02420353|142810517|OTHER|mixed effects model||||||0.0122|||||||Mixed Models Analysis|||||||0.0122
71646969|NCT02420353|142810518|OTHER|mixed effects model||||||0.5853|||||||Mixed Models Analysis|||||||0.5853
71646970|NCT02420353|142810519|OTHER|mixed effects model||||||0.6288|||||||Mixed Models Analysis|||||||0.6288
71646971|NCT02420353|142810520|OTHER|mixed effects model||||||0.5022|||||||Mixed Models Analysis|||||||0.5022
71646972|NCT02420353|142810521|OTHER|mixed effects model||||||0.7507|||||||Mixed Models Analysis|||||||0.7507
71646973|NCT02420353|142810522|OTHER|mixed effects model|||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71646974|NCT02420353|142810523|OTHER|mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
71646975|NCT02420353|142810524|OTHER|mixed effects model||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
71646976|NCT02420353|142810525|OTHER|Mixed effects model||||||0.8581|||||||Mixed Models Analysis|||||||0.8581
71646977|NCT01149057|142810529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
71824217|NCT02501811|143152044|OTHER||slope of time|0.141|STANDARD_ERROR_OF_MEAN|0.153||0.361|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.361
71646978|NCT01149057|142810530|SUPERIORITY_OR_OTHER|||||||0.3778|TWO_SIDED|||||P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of L1-L4 T-scores||||0.3778
71646979|NCT01149057|142810530|SUPERIORITY_OR_OTHER|||||||0.1541|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total spine T-score||||0.1541
71646980|NCT01149057|142810530|SUPERIORITY_OR_OTHER|||||||0.789|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total hip - left T-score||||0.7890
71646981|NCT01149057|142810530|SUPERIORITY_OR_OTHER|||||||0.7094|TWO_SIDED|||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Femoral neck - left T-scores.||||0.7094
71646982|NCT01149057|142810536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
71646983|NCT01149057|142810536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
71646984|NCT01149057|142810536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
71646985|NCT01149057|142810536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
71886404|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.43|||<|0.0001|TWO_SIDED|95.0|4.5|15.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||15.80|4.50|<0.0001
71886405|NCT00848354|143293307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001|TWO_SIDED|95.0|3.5|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||10.47|3.50|<0.0001
71886406|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
71646986|NCT01149057|142810537|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71646987|NCT01149057|142810538|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71646988|NCT01149057|142810539|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71646989|NCT01149057|142810540|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.||||<0.0001
71646990|NCT01149057|142810541|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71646991|NCT01149057|142810542|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71646992|NCT01149057|142810543|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired sample T-test|||||||<0.0001
71646993|NCT01149057|142810544|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24||||<0.0001
71646994|NCT01149057|142810544|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48||||<0.0001
71646995|NCT01149057|142810544|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72||||<0.0001
71646996|NCT01149057|142810544|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96||||<0.0001
71646997|NCT00577655|142810554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.496||||0.0138|TWO_SIDED|95.0|0.729|6.262||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||6.262|0.729|0.0138
71646998|NCT00577655|142810555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431||||0.0403|TWO_SIDED|95.0|0.244|10.618||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.||10.618|0.244|0.0403
71646999|NCT00577655|142810556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.536||||0.0031|TWO_SIDED|95.0|1.567|7.505||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||7.505|1.567|0.0031
71647000|NCT00577655|142810556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.067||||0.047|TWO_SIDED|95.0|0.041|6.094||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."||6.094|0.041|0.0470
71647001|NCT00577655|142810557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.572||||0.0074|TWO_SIDED|95.0|2.077|13.067||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||13.067|2.077|0.0074
71647002|NCT00577655|142810557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.782||||0.1843|TWO_SIDED|95.0|-1.832|9.397||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."||9.397|-1.832|0.1843
71647003|NCT00577655|142810558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.707||||0.0507|TWO_SIDED|95.0|-0.03|19.445||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||19.445|-0.030|0.0507
71647004|NCT00577655|142810558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.892||||0.924|TWO_SIDED|95.0|-17.634|19.419||significance level of 0.05.|ANOVA|terms for treatment and center|Active - Placebo|Day 1 Baseline||19.419|-17.634|0.9240
71647005|NCT00577655|142810559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.124||||0.2186|TWO_SIDED|95.0|-18.169|78.417||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline||78.417|-18.169|0.2186
71647006|NCT00577655|142810559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.578||||0.2375|TWO_SIDED|95.0|-28.541|113.7||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 1 Baseline||113.70|-28.541|0.2375
71647007|NCT00577655|142810560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.524||||0.0017|TWO_SIDED|95.0|2.524|10.523||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 1||10.523|2.524|0.0017
71647008|NCT00577655|142810560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.998||||0.0521|TWO_SIDED|95.0|-0.037|8.032||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 22||8.032|-0.037|0.0521
71647009|NCT00577655|142810561|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.477||||0.0647|TWO_SIDED|95.0|0.98|2.23||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||2.23|0.98|0.0647
71647010|NCT00577655|142810561|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.088||||0.0005|TWO_SIDED|95.0|1.38|3.15||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||3.15|1.38|0.0005
71886407|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
71647011|NCT00577655|142810562|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.141||||0.5059|TWO_SIDED|95.0|0.77|1.69||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1||1.69|0.77|0.5059
71886408|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
71647012|NCT00577655|142810562|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.533||||0.0333|TWO_SIDED|95.0|1.03|2.27||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22||2.27|1.03|0.0333
71647013|NCT00577655|142810563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.3888
71647014|NCT00577655|142810563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1249||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.1249
71647015|NCT00577655|142810564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0343||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0343
71647016|NCT00577655|142810564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0962||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0962
71647017|NCT00577655|142810565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0109
71647018|NCT00577655|142810565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0845
71647019|NCT00577655|142810566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||significance level of 0.05.|Fisher Exact|||Day 1||||0.0013
71647020|NCT00577655|142810566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||significance level of 0.05.|Fisher Exact|||Day 22||||0.0085
71647021|NCT00577655|142810567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.072||||0.4674|TWO_SIDED|95.0|-0.265|0.122||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||0.122|-0.265|0.4674
71647022|NCT00577655|142810567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171||||0.084|TWO_SIDED|95.0|-0.365|0.023||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 2||0.023|-0.365|0.0840
71647023|NCT00577655|142810567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.138||||0.1699|TWO_SIDED|95.0|-0.335|0.059||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 3||0.059|-0.335|0.1699
71647024|NCT00577655|142810569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.926||||0.1391|TWO_SIDED|95.0|-3.256|23.108||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1||23.108|-3.256|0.1391
71647025|NCT00577655|142810569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.923||||0.1043|TWO_SIDED|95.0|-2.278|24.124||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 2||24.124|-2.278|0.1043
71647026|NCT00577655|142810569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.546||||0.157|TWO_SIDED|95.0|-3.705|22.798||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 3||22.798|-3.705|0.1570
71647027|NCT00577655|142810570|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.989||||0.9846|TWO_SIDED|95.0|-0.121|2.099||significance level of 0.05.|mixed poisson regression model|||"Week 1~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.099|-0.121|0.9846
71647028|NCT00577655|142810570|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.961||||0.9447|TWO_SIDED|95.0|-0.116|2.039||significance level of 0.05.|mixed poisson regression model|||"Week 2~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||2.039|-0.116|0.9447
71647029|NCT00577655|142810570|SUPERIORITY_OR_OTHER_LEGACY||ratio of Active to Placebo|0.887||||0.8326|TWO_SIDED|95.0|-0.111|1.885||significance level of 0.05.|mixed poisson regression model|||"Week 3~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."||1.885|-0.111|0.8326
71647030|NCT01370863|142810582|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-1.452||||0.869|TWO_SIDED|95.0|-19.054|16.149|||ANCOVA|||||16.149|-19.054|0.869
71647031|NCT01370863|142810583|SUPERIORITY_OR_OTHER_LEGACY||Diference in LS means|0.264||||0.487|TWO_SIDED|95.0|-0.495|1.024|||ANCOVA|||||1.024|-0.495|0.487
71647032|NCT01370863|142810584|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.087||||0.637|TWO_SIDED|95.0|-0.501|0.326|||ANCOVA|||||0.326|-0.501|0.637
71647033|NCT00834561|142810613|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.14||||||90.0|99.99|108.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.47|99.99|
71647034|NCT00834561|142810614|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.07||||||90.0|101.33|106.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.89|101.33|
71647035|NCT00834561|142810615|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.68||||||90.0|101.42|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.00|101.42|
71647036|NCT01151618|142810619|OTHER|"Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):~Sensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M\&W) \* 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M\&W) \* 100"|DeltaXrs (cmH2O*s/L)|2.6|||||TWO_SIDED|90.0|0.0|100.0|||||DeltaXrs equals average inspiratory reactance minus average expiratory reactance.|||100|0|
71647037|NCT03277248|142810622|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.509||||0.0022|TWO_SIDED|95.0|0.33|0.784||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.784|0.330|0.0022
71647038|NCT03277248|142810623|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.035|||<|0.0001|TWO_SIDED|95.0|0.019|0.064||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.064|0.019|<.0001
71647039|NCT03277248|142810624|SUPERIORITY||Rate Ratio (Ublituximab / Teriflunomide)|0.1|||<|0.0001|TWO_SIDED|95.0|0.073|0.136||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.136|0.073|<.0001
71824218|NCT02501811|143152045|OTHER||slope of time|-0.267|STANDARD_ERROR_OF_MEAN|0.164||0.107|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.107
71647040|NCT03277248|142810626|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|7.946|||<|0.0001|TWO_SIDED|95.0|4.917|12.841||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1-unenhancing, T2, Gd-enhancing) as covariates.|Regression, Logistic|||||12.841|4.917|<.0001
71647041|NCT03277248|142810627|SUPERIORITY||Odds Ratio (Ublituximab / Teriflunomide)|0.862||||0.429|TWO_SIDED|95.0|0.596|1.246||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||1.246|0.596|0.4290
71647042|NCT03277248|142810628|SUPERIORITY||Least Squares Mean Difference|-0.018||||0.3108|TWO_SIDED|95.0|-0.053|0.017||Mixed model repeated measures (MMRM) model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures|||||0.017|-0.053|0.3108
71647043|NCT00556673|142810703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|||<|0.0001|TWO_SIDED|90.0|0.28|0.51||"Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.~A significance level of 5% was used to determine statistical significance."|1-sided|||The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.||0.51|0.28|< 0.0001
71647044|NCT01131260|142810718|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.2|TWO_SIDED|95.0|0.87|1.98|||Chi-squared|||Analysis on primary composite outcome as a whole.||1.98|0.87|0.20
71647045|NCT01131260|142810720|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.02||||0.37|TWO_SIDED|95.0|0.31|29.1|||Fisher Exact|||||29.1|0.31|0.37
71647046|NCT01131260|142810721|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.86||||0.02|TWO_SIDED|95.0|1.13|7.24|||Chi-squared|||||7.24|1.13|0.02
71647047|NCT01131260|142810722|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76||||1|TWO_SIDED|95.0|0.17|3.38|||Fisher Exact|||||3.38|0.17|1.0
71647048|NCT01131260|142810723|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.13|TWO_SIDED|95.0|0.1|1.41|||Chi-squared|||||1.41|0.10|0.13
71647049|NCT01131260|142810724|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.57||||0.07|TWO_SIDED|95.0|0.97|2.54|||Chi-squared|||||2.54|0.97|0.07
71824219|NCT02501811|143152046|OTHER||slope of time|1.395|STANDARD_ERROR_OF_MEAN|0.829||0.095|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.095
71647050|NCT01131260|142810725|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||1|TWO_SIDED|95.0|0.22|3.0|||Fisher Exact|||||3.00|0.22|1.0
71647051|NCT01131260|142810726|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||.17
71647052|NCT01131260|142810727|SUPERIORITY_OR_OTHER|||||||0.45||||||The p value was calculated based on the entire study cohort.|Chi-squared|||||||0.45
71647053|NCT01131260|142810729|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||.32
71647054|NCT01131260|142810730|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
71647055|NCT01131260|142810731|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||||||0.40
71647056|NCT01131260|142810732|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
71647057|NCT01131260|142810733|SUPERIORITY_OR_OTHER|||||||0.19|||||||Chi-squared|||||||.19
71647058|NCT01131260|142810734|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71647059|NCT01131260|142810735|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
71647060|NCT01131260|142810736|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71647061|NCT01131260|142810737|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
71647062|NCT01131260|142810738|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||.05
71647063|NCT03544216|142810739|OTHER||||||<|0.001||||||"Results of post-hoc analyses comparing scores of each lens type to one another:~Habitual lens and multifocal contact lens: p \<0.001 Habitual lens and single vision lens: p \<0.001 Multifocal lens and single vision lens: p = 0.08"|Generalized linear models|||Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)||||<0.001
71647064|NCT03544216|142810739|OTHER|||||||0.5||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)||||0.5
71647065|NCT03544216|142810739|OTHER|||||||0.7||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)||||0.7
71647066|NCT03544216|142810739|OTHER|||||||0.3||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)||||0.3
71647067|NCT03544216|142810739|OTHER|||||||0.047||||||Analysis controlled for order, visit, and repeated measures|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to \<35 years old and 35 to 40 years old, by self report)|"Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type\*age group) produced the following results:~p = 0.01 for MF\*\<35 age group compared to Single Vision (SV)\*\<35 age group p = 0.07 for MF\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\<35 age group compared to Single Vision (SV)\*\>35 age group p \> 0.05 for SV\*\<35 age group compared to SV\*\>35 age group p \>0.05 for SV\*\<35 age group compared to MF\*\>35 age group p \> 0.05 for MF\*\>35 age group compared to SV\*\>25 age group"|||0.047
71647068|NCT00874276|142810740|SUPERIORITY_OR_OTHER||Kendall's Tau-B|0.6|STANDARD_ERROR_OF_MEAN|0.127||0.023|TWO_SIDED|95.0|0.35|0.85||This is the primary outcome, and there is no adjustment.|Wilcoxon (Mann-Whitney)|||We used a Wilcoxon test (and accompanying Kendal's Tau B) because these outcomes are outlier prone.||0.85|0.35|0.023
71647069|NCT00874276|142810741|SUPERIORITY_OR_OTHER||Kendall's Tau B|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.42|TWO_SIDED|95.0|-0.23|0.69|||Wilcoxon (Mann-Whitney)|||This is the same analysis as the previous, except we use the day 5 pharmacogenetics on the amount of time needed to clear one-half of dose of the drug. This is for the environmental dose. A positive (negative) Kendall's Tau is associated with the EGT allele being faster (slower) than lacking EGT in terms of metabolization of DCA.||0.69|-0.23|0.42
71647070|NCT01894230|142810781|EQUIVALENCE|Month 3|Slope|-0.0189|STANDARD_ERROR_OF_MEAN|0.3986||0.96|TWO_SIDED||||||Regression, Linear|||||||0.96
71647071|NCT01894230|142810781|EQUIVALENCE|Month 8|Slope|-0.2468|STANDARD_ERROR_OF_MEAN|0.4315||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
71647072|NCT01894230|142810782|EQUIVALENCE|Month 3|Slope|-11.32|STANDARD_ERROR_OF_MEAN|5.68||0.0482|TWO_SIDED||||||Regression, Linear|||||||0.0482
71647073|NCT01894230|142810782|EQUIVALENCE|Month 8|Slope|-9.9|STANDARD_ERROR_OF_MEAN|6.333||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
71647074|NCT01894230|142810783|EQUIVALENCE|MPR calculated from baseline to last patient follow-up (3 months or 8 months)|Slope|-0.053|STANDARD_ERROR_OF_MEAN|0.091||0.6692|TWO_SIDED||||||Regression, Linear|||||||0.6692
71647075|NCT01894230|142810784|EQUIVALENCE|Baseline to Month 3|Odds Ratio (OR)|2.025||||0.0371|TWO_SIDED|95.0|1.043|3.929|||Regression, Logistic|||||3.929|1.043|0.0371
71647076|NCT01894230|142810784|EQUIVALENCE|Month 3 to Month 8|Odds Ratio (OR)|1.115||||0.8815|TWO_SIDED|95.0|0.265|4.687|||Regression, Logistic|||||4.687|0.265|0.8815
71647077|NCT01894230|142810785|EQUIVALENCE|Month 3|Slope|0.143|STANDARD_ERROR_OF_MEAN|0.27||0.5965|TWO_SIDED||||||Regression, Linear|||||||0.5965
71647078|NCT01894230|142810785|EQUIVALENCE|Month 8|Slope|0.258|STANDARD_ERROR_OF_MEAN|0.346||0.4579|TWO_SIDED||||||Regression, Linear|||||||0.4579
71647079|NCT01894230|142810786|EQUIVALENCE|Month 3|Slope|0.098|STANDARD_ERROR_OF_MEAN|0.163||0.5477|TWO_SIDED||||||Regression, Linear|||||||0.5477
71647080|NCT01894230|142810786|EQUIVALENCE|Month 8|Slope|0.298|STANDARD_ERROR_OF_MEAN|0.145||0.0429|TWO_SIDED||||||Regression, Linear|||||||0.0429
71647081|NCT01894230|142810787|EQUIVALENCE|Month 3|Slope|-0.211|STANDARD_ERROR_OF_MEAN|0.881||0.8106|TWO_SIDED||||||Regression, Linear|||||||0.8106
71647082|NCT01894230|142810787|EQUIVALENCE|Month 8|Slope|0.646|STANDARD_ERROR_OF_MEAN|1.009||0.5233|TWO_SIDED||||||Regression, Linear|||||||0.5233
71647083|NCT01894230|142810788|EQUIVALENCE|Month 3|Slope|-0.6001|STANDARD_ERROR_OF_MEAN|1.472||0.6841|TWO_SIDED||||||Regression, Linear|||||||0.6841
71647084|NCT01894230|142810788|EQUIVALENCE|Month 8|Slope|-0.771|STANDARD_ERROR_OF_MEAN|1.781||0.6658|TWO_SIDED||||||Regression, Linear|||||||0.6658
71647085|NCT01894230|142810789|EQUIVALENCE|Month 8|Odds Ratio (OR)|1.085||||0.8384|TWO_SIDED|95.0|0.495|2.38|||Regression, Logistic|Ordinal Logistic||||2.380|0.495|0.8384
71647086|NCT01894230|142810790|EQUIVALENCE|Month 3 BMQ Necessity|Slope|1.163|STANDARD_ERROR_OF_MEAN|0.584||0.0486|TWO_SIDED||||||Regression, Linear|||||||0.0486
71647087|NCT01894230|142810790|EQUIVALENCE|Month 8, BMQ Necessity|Slope|0.248|STANDARD_ERROR_OF_MEAN|0.67||0.7235|TWO_SIDED||||||Regression, Linear|||||||0.7235
71647088|NCT01894230|142810790|EQUIVALENCE|Month 3, BMQ Concerns|Slope|-0.862|STANDARD_ERROR_OF_MEAN|0.686||0.2113|TWO_SIDED||||||Regression, Linear|||||||0.2113
71647089|NCT01894230|142810790|EQUIVALENCE|Month 8, BMQ Concerns|Slope|-1.0083|STANDARD_ERROR_OF_MEAN|0.737||0.1739|TWO_SIDED||||||Regression, Linear|||||||0.1739
71647090|NCT04364854|142810821|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-2.31|1.87|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.87|-2.31|
71647091|NCT04364854|142810821|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.94|3.15|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||3.15|-2.94|
71647092|NCT04364854|142810821|OTHER|This study was not designed to perform a hypothesis test. No p-values will be reported.|Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-2.9|1.33|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM, and age.|||1.33|-2.9|
71647093|NCT04364854|142810822|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.26|0.13|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.13|-0.26|
71647094|NCT04364854|142810822|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||0.28|-0.21|
71647095|NCT04364854|142810822|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.42|-0.04|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline SAQOL-39, and age.|||-0.04|-0.42|
71647096|NCT04364854|142810823|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-2.59|2.9|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.9|-2.59|
71647097|NCT04364854|142810823|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|-2.23|3.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM-Narrative, and age.|||3.8|-2.23|
71647098|NCT04364854|142810823|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-2.32|2.82|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Narrative, and age.|||2.82|-2.32|
71647099|NCT04364854|142810824|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-3.59|3.45|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||3.45|-3.59|
71647100|NCT04364854|142810824|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-4.27|4.8|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||4.8|-4.27|
71824220|NCT02501811|143152047|OTHER||slope of time|0.603|STANDARD_ERROR_OF_MEAN|0.683||0.379|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.379
71647101|NCT04364854|142810824|OTHER|This trial was not designed for hypothesis testing. No p-values will be reported.|Mean Difference (Net)|-2.11|||||TWO_SIDED|95.0|-5.77|1.56|||||Analyzed using a repeated measures model that included the following fixed affects: categorical visit by treatment group interaction, site, baseline aphasia severity score, baseline VPM - Procedural, and age.|||1.56|-5.77|
71647102|NCT01472432|142810825|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
71647103|NCT01472432|142810826|SUPERIORITY_OR_OTHER||||||<|0.05||||||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"|t-test, 2 sided|"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months"||"* Vildagliptin vs Placebo at 3 months.~* Placebo baseline versus placebo 3 months.~* Vildagliptin baseline versus Vildagliptin 3 months."||||<0.05
71647104|NCT01472432|142810827|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P\< 0.05 versus control patients. P \< 0.05 versus baseline.|t-test, 2 sided|||p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.||||<0.05
71647105|NCT01472432|142810828|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\< 0.05 versus control patients. P \< 0.05 versus baseline|t-test, 2 sided|||||||<0.05
71886409|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
71647106|NCT01390415|142810832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0374||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0374
71647107|NCT01390415|142810833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0566||95.0|||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6||||0.0566
71647108|NCT02435433|142810834|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0199|TWO_SIDED|95.0|0.531|0.949|||Log Rank||Stratified analysis|||0.949|0.531|0.0199
71647109|NCT02435433|142810835|SUPERIORITY||Hazard Ratio (HR)|0.452|||<|0.0001|TWO_SIDED|95.0|0.339|0.603|||Log Rank||Stratified analysis|||0.603|0.339|<0.0001
71647110|NCT02435433|142810836|SUPERIORITY||Hazard Ratio (HR)|0.427|||<|0.0001|TWO_SIDED|95.0|0.313|0.582|||Log Rank||Stratified analysis|||0.582|0.313|<0.0001
71647111|NCT02435433|142810837|SUPERIORITY||Odds Ratio (OR)|4.6||||0.1697|TWO_SIDED|95.0|0.6|37.3|||Cochran-Mantel-Haenszel||Stratified analysis|||37.3|0.6|0.1697
71647112|NCT02435433|142810841|SUPERIORITY||Hazard Ratio (HR)|0.799||||0.2382|TWO_SIDED|95.0|0.545|1.171|||Log Rank||Stratified analysis|||1.171|0.545|0.2382
71647113|NCT04406194|142810896|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean Ratio|0.9684||||0|TWO_SIDED|90.0|0.94|0.9977|||ANOVA|||||0.9977|0.9400|0.0000
71647114|NCT04406194|142810897|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean Ratio|1.0555||||0.0155|TWO_SIDED|90.0|0.9292|1.1989|||ANOVA|||||1.1989|0.9292|0.0155
71647115|NCT04406194|142810898|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean Ratio|0.9719||||0|TWO_SIDED|90.0|0.944|1.0006|||ANOVA|||||1.0006|0.9440|0.0000
71647116|NCT02640235|142810912|NON_INFERIORITY|The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel.|Difference in avg predicted proportion|-8.5|||||TWO_SIDED|95.0|-15.6|-1.4|||Regression, Logistic|||||-1.4|-15.6|
71647117|NCT02640235|142810915|OTHER||Difference in avg predicted proportion|4.7|||||TWO_SIDED|95.0|-3.6|13.1|||Regression, Logistic|||||13.1|-3.6|
71647118|NCT02640235|142810916|OTHER||Difference in avg predicted proportion|-6.2|||||TWO_SIDED|95.0|-12.0|-0.5|||Regression, Logistic|||||-0.5|-12|
71647119|NCT02640235|142810917|OTHER||Difference in avg predicted proportion|-0.7|||||TWO_SIDED|95.0|-5.7|4.3|||Regression, Logistic|||||4.3|-5.7|
71647120|NCT02640235|142810918|OTHER||Difference in avg predicted proportion|0.2|||||TWO_SIDED|95.0|-3.9|4.4|||Regression, Logistic|||||4.4|-3.9|
71886410|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
71647121|NCT00270634|142810920|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|-3.2|||||ONE_SIDED|95.0||1.3|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|The 6-month BPAR rate was used to calculate an estimate of the difference in rates between each VCS group and TAC, combining across pooled investigative center strata, weighted by the number of patients in each of the pooled center strata. The overall standard error was estimated for the linear combination of proportions. Using this statistic and its standard error, the upper bound one-sided 95% C.I. was constructed for the difference in BPAR rates between groups (VCS - TAC).||1.3||
71647122|NCT00270634|142810920|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.6|||||ONE_SIDED|95.0||10.8|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||10.8||
71647123|NCT00270634|142810920|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be -0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.9|||||ONE_SIDED|95.0||11.4|||t-test, 1 sided||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|||11.4||
71647124|NCT02235870|142810963|SUPERIORITY||Least-Square Mean Difference|3.28||||0.0261|TWO_SIDED|95.0|2.24|4.32|||ANCOVA|||||4.32|2.24|0.0261
71647125|NCT02235870|142810964|SUPERIORITY||Exact Confidence Interval|64.9|||<|0.0001|TWO_SIDED|95.0|57.5|71.7|||Exact Test|||Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.||71.7|57.5|<0.0001
71647126|NCT02235870|142810965|SUPERIORITY||Percentage Difference|32.8|||<|0.0001|TWO_SIDED|95.0|23.1|42.5|||Chi-squared|||||42.5|23.1|<0.0001
71660963|NCT03118570|142835406|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.278||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.278
71647127|NCT01046084|142810966|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||TWO_SIDED|90.0|86.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|86.5|
71647128|NCT01046084|142810967|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.0|||||TWO_SIDED|90.0|89.3|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120|89.3|
71647129|NCT01046084|142810968|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.0|||||TWO_SIDED|90.0|92.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||123|92.5|
71647130|NCT02670551|142811083|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.0331|TWO_SIDED|95.0|-4.6|-0.4||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.4|-4.6|0.0331
71647131|NCT02670551|142811083|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.0103|TWO_SIDED|95.0|-5.1|-0.9||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.9|-5.1|0.0103
71647132|NCT02670551|142811084|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0714|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||0.0|-0.5|0.0714
71647133|NCT02670551|142811084|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.0662|TWO_SIDED|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.||-0.0|-0.5|0.0662
71647134|NCT04476277|142811085|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71647135|NCT04476277|142811087|OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71647136|NCT04476277|142811088|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71647137|NCT04476277|142811089|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71824221|NCT02501811|143152048|OTHER||slope of time|0.003|STANDARD_ERROR_OF_MEAN|0.004||0.401|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.401
71647138|NCT04476277|142811090|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71647139|NCT04476277|142811091|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71647140|NCT04476277|142811092|OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
71647141|NCT04476277|142811093|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
71647142|NCT04476277|142811094|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
71647143|NCT04476277|142811095|OTHER|||||||0.43|||||||t-test, 2 sided|||||||0.43
71647144|NCT04476277|142811096|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71647145|NCT04476277|142811097|OTHER|||||||0.01|||||||t-test, 1 sided|||||||0.01
71647146|NCT04476277|142811098|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71647147|NCT02597049|142811126|SUPERIORITY||Mean Difference (Final Values)|-0.79|||<|0.001|TWO_SIDED|95.0|-0.97|-0.61|||Mixed Models Analysis|||||-0.61|-0.97|<.001
71647148|NCT02597049|142811126|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.84|-0.49|||Mixed Models Analysis|||||-0.49|-0.84|< .001
71647149|NCT02597049|142811127|SUPERIORITY||Mean Difference (Final Values)|-0.82|||<|0.001|TWO_SIDED|95.0|-1.0|-0.64|||Mixed Models Analysis|||||-0.64|-1.00|<.001
71647150|NCT02597049|142811127|SUPERIORITY||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.86|-0.51|||Mixed Models Analysis|||||-0.51|-0.86|<.001
71647151|NCT02597049|142811128|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
71647152|NCT02597049|142811128|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand||||< .001
71647153|NCT02597049|142811128|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
71647154|NCT02597049|142811128|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand||||< .001
71647155|NCT02597049|142811129|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.027|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||Treatment-regimen Estimand||-0.1|-1.8|0.027
71647156|NCT02597049|142811129|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.264|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Treatment-regimen Estimand||0.4|-1.3|0.264
71647157|NCT02597049|142811129|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.059|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||Efficacy Estimand||0.0|-1.7|0.059
71647158|NCT02597049|142811129|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.435|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||Efficacy Estimand||0.5|-1.2|0.435
71647159|NCT02597049|142811130|SUPERIORITY||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-30.8|-18.6|||ANCOVA|||Treatment-regimen Estimand||-18.6|-30.8|< .001
71886411|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
71647160|NCT02597049|142811130|SUPERIORITY||Mean Difference (Final Values)|-19.6|||<|0.001|TWO_SIDED|95.0|-25.7|-13.5||Test was not controlled for type I error.|ANCOVA|||Treatment-regimen Estimand||-13.5|-25.7|<0.001
71647161|NCT02597049|142811130|SUPERIORITY||Mean Difference (Final Values)|-26.6|||<|0.001|TWO_SIDED|95.0|-32.7|-20.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-20.6|-32.7|<0.001
71647162|NCT02597049|142811130|SUPERIORITY||Mean Difference (Final Values)|-20.7|||<|0.001|TWO_SIDED|95.0|-26.7|-14.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand||-14.6|-26.7|<0.001
71647163|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-19.7|||<|0.001|TWO_SIDED|95.0|-25.7|-13.8|||Mixed Models Analysis|||Pre-morning meal.||-13.8|-25.7|< .001
71647164|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-21.2|-9.2|||Mixed Models Analysis|||Pre-morning meal||-9.2|-21.2|< .001
71647165|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-33.8|-15.3|||Mixed Models Analysis|||2-hour postprandial||-15.3|-33.8|< .001
71647166|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-30.3|-11.8|||Mixed Models Analysis|||2-hour postprandial||-11.8|-30.3|< .001
71647167|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-18.3|||<|0.001|TWO_SIDED|95.0|-26.4|-10.2|||Mixed Models Analysis|||Pre-midday meal||-10.2|-26.4|< .001
71647168|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.5|-6.2|||Mixed Models Analysis|||Pre-midday meal||-6.2|-22.5|< .001
71647169|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-19.0|||<|0.001|TWO_SIDED|95.0|-28.8|-9.3|||Mixed Models Analysis|||2-hour postprandial after midday meal||-9.3|-28.8|< .001
71647170|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.01|TWO_SIDED|95.0|-22.5|-3.1|||Mixed Models Analysis|||2-hour postprandial after midday meal||-3.1|-22.5|0.010
71647171|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-22.7|||<|0.001|TWO_SIDED|95.0|-30.7|-14.7|||Mixed Models Analysis|||Pre-evening meal||-14.7|-30.7|< .001
71647172|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-22.5|||<|0.001|TWO_SIDED|95.0|-30.7|-14.4|||Mixed Models Analysis|||Pre-evening meal||-14.4|-30.7|< .001
71647173|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-22.1|||<|0.001|TWO_SIDED|95.0|-31.4|-12.9|||Mixed Models Analysis|||2-hour postprandial after evening meal||-12.9|-31.4|< .001
71647174|NCT02597049|142811131|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.0|-7.4|||Mixed Models Analysis|||2-hour postprandial after evening meal||-7.4|-26.0|< .001
71647175|NCT02597049|142811132|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||ANCOVA|||Treatment-regimen Estimand||-0.1|-2.3|0.032
71647176|NCT02597049|142811132|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.273|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||Treatment-regimen Estimand||0.5|-1.7|0.273
71647177|NCT02597049|142811132|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.023|TWO_SIDED|95.0|-2.4|-0.2|||ANCOVA|||Efficacy Estimand||-0.2|-2.4|0.023
71647178|NCT02597049|142811132|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.32|TWO_SIDED|95.0|-1.7|0.6|||ANCOVA|||Efficacy Estimand||0.6|-1.7|0.320
71647179|NCT02463487|142811137|OTHER|||||||0.87|||||||t-test, 1 sided|||||||0.87
71647180|NCT02463487|142811139|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
71647181|NCT01390948|142811143|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.1292|TWO_SIDED|95.0|0.9|2.3|||Log Rank|||||2.30|0.90|0.1292
71647182|NCT03555695|142811168|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
71647183|NCT00835081|142811199|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|95.9|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||110|95.9|
71647184|NCT00835081|142811200|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.5|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||103|97.5|
71660964|NCT03118570|142835406|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.292||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.292
71647185|NCT00835081|142811201|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|97.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%|||102|97.4|
71647186|NCT00421304|142811202|SUPERIORITY|||||||0.218|||||||Wilcoxon's rank-sum test|||||||0.218
71647187|NCT00421304|142811202|SUPERIORITY|||||||0.643|||||||Wilcoxon's rank-sum test|||||||0.643
71647188|NCT00421304|142811202|SUPERIORITY|||||||0.677|||||||Wilcoxon's rank-sum test|||||||0.677
71647189|NCT00421304|142811203|SUPERIORITY|||||||0.257|||||||Wilcoxon's rank-sum test|||||||0.257
71647190|NCT00421304|142811203|SUPERIORITY|||||||0.726|||||||Wilcoxon's rank-sum test|||||||0.726
71647191|NCT00421304|142811203|SUPERIORITY|||||||0.551|||||||Wilcoxon's rank-sum test|||||||0.551
71647192|NCT00421304|142811204|SUPERIORITY|||||||0.591|||||||Wilcoxon's rank-sum test|||||||0.591
71647193|NCT00421304|142811204|SUPERIORITY|||||||0.393|||||||Wilcoxon's rank-sum test|||||||0.393
71647194|NCT00421304|142811204|SUPERIORITY|||||||0.586|||||||Wilcoxon's rank-sum test|||||||0.586
71647195|NCT00421304|142811205|SUPERIORITY|||||||0.894|||||||Wilcoxon's rank-sum test|||||||0.894
71647196|NCT00421304|142811205|SUPERIORITY|||||||0.674|||||||Wilcoxon's rank-sum test|||||||0.674
71886412|NCT00848354|143293309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
71647197|NCT00421304|142811205|SUPERIORITY|||||||0.636|||||||Wilcoxon's rank-sum test|||||||0.636
71647198|NCT00421304|142811206|SUPERIORITY|||||||0.397|||||||Wilcoxon's rank-sum test|||||||0.397
71647199|NCT00421304|142811206|SUPERIORITY|||||||0.238|||||||Wilcoxon's rank-sum test|||||||0.238
71647200|NCT00421304|142811206|SUPERIORITY|||||||0.461|||||||Wilcoxon's rank-sum test|||||||0.461
71647201|NCT00421304|142811207|SUPERIORITY|||||||0.322|||||||Wilcoxon's rank-sum test|||||||0.322
71647202|NCT00421304|142811207|SUPERIORITY|||||||0.747|||||||Wilcoxon's rank-sum test|||||||0.747
71647203|NCT00421304|142811207|SUPERIORITY|||||||0.717|||||||Wilcoxon's rank-sum test|||||||0.717
71647204|NCT00421304|142811208|SUPERIORITY|||||||0.847|||||||Wilcoxon's rank-sum test|||||||0.847
71647205|NCT00421304|142811208|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71647206|NCT00421304|142811208|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71647207|NCT00421304|142811209|SUPERIORITY|||||||0.653|||||||Wilcoxon's rank-sum test|||||||0.653
71647208|NCT00421304|142811209|SUPERIORITY|||||||0.283|||||||Wilcoxon's rank-sum test|||||||0.283
71647209|NCT00421304|142811209|SUPERIORITY|||||||0.411|||||||Wilcoxon's rank-sum test|||||||0.411
71647210|NCT00421304|142811210|SUPERIORITY|||||||0.988|||||||Wilcoxon's rank-sum test|||||||0.988
71647211|NCT00421304|142811210|SUPERIORITY|||||||0.832|||||||Wilcoxon's rank-sum test|||||||0.832
71647212|NCT00421304|142811210|SUPERIORITY|||||||0.748|||||||Wilcoxon's rank-sum test|||||||0.748
71647213|NCT00421304|142811211|SUPERIORITY|||||||0.28|||||||Wilcoxon's rank-sum test|||||||0.280
71647214|NCT00421304|142811211|SUPERIORITY|||||||0.108|||||||Wilcoxon's rank-sum test|||||||0.108
71647215|NCT00421304|142811211|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71647216|NCT00421304|142811212|SUPERIORITY|||||||0.742|||||||Wilcoxon's rank-sum test|||||||0.742
71647217|NCT00421304|142811212|SUPERIORITY|||||||0.486|||||||Wilcoxon's rank-sum test|||||||0.486
71647218|NCT00421304|142811212|SUPERIORITY|||||||0.49|||||||Wilcoxon's rank-sum test|||||||0.490
71647219|NCT00421304|142811213|SUPERIORITY|||||||1|||||||Wilcoxon's rank-sum test|||||||1.000
71647220|NCT00421304|142811214|SUPERIORITY|||||||0.05|||||||Wilcoxon's rank-sum test|||||||0.050
71647221|NCT00421304|142811215|SUPERIORITY|||||||0.008|||||||Wilcoxon's rank-sum test|||||||0.008
71647222|NCT00421304|142811216|SUPERIORITY|||||||0.012|||||||Wilcoxon's rank-sum test|||||||0.012
71647223|NCT00421304|142811217|SUPERIORITY||||||<|0.001|||||||Wilcoxon's rank-sum test|||||||<0.001
71647224|NCT02535923|142811271|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
71647225|NCT02535923|142811271|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
71647226|NCT02535923|142811272|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||.83
71647227|NCT02535923|142811273|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
71647228|NCT02535923|142811274|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||.16
71647229|NCT02535923|142811275|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
71647230|NCT02906813|142811277|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Ratio|0.631||||0.079|TWO_SIDED|90.0|0.411|0.969|||ANOVA|||Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.||0.969|0.411|0.079
71647231|NCT02906813|142811277|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.403||||0.002|TWO_SIDED|90.0|0.262|0.618|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.||0.618|0.262|0.002
71647232|NCT02906813|142811278|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.85||||0.146|TWO_SIDED|90.0|0.706|1.024|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.024|0.706|0.146
71647233|NCT02906813|142811278|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.889||||0.281|TWO_SIDED|90.0|0.738|1.07|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.070|0.738|0.281
71647234|NCT02906813|142811279|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.842||||0.191|TWO_SIDED|90.0|0.676|1.05|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.050|0.676|0.191
71647235|NCT02906813|142811279|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.894||||0.355||90.0|0.726|1.1|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.||1.100|0.726|0.355
71647236|NCT00396162|142811308|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 2 sided|||||||0.23
71647237|NCT00396162|142811309|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||||||.31
71647238|NCT02854800|142811335|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||A separate t-test for each row was used to compare dropouts and completers.||||<0.05
71647239|NCT02854800|142811337|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used to compare mean medication side effect ratings across the three arms/groups to determine whether one group had more severe symptoms that may have been related to study dropout.||||<0.05
71647240|NCT02854800|142811340|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Mixed ANOVA was used with Study Week (1-12) as the within-subjects, repeated-measures factor and Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71647241|NCT02854800|142811341|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||One-way ANOVA was used for each side effect rating with Group as the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71647242|NCT02854800|142811342|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71647243|NCT02854800|142811344|SUPERIORITY||||||<|0.05|||||||ANOVA|If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||Data were analyzed via mixed ANOVA whereby Study Visit (1-4) was the repeated-measures factor and Group (weekly, biweekly, monthly) was the between-subjects factor. If the overall F test was significant, Tukey's Honestly Significant Difference post-hoc tests were performed.||||<0.05
71647244|NCT02627963|142811359|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0165|TWO_SIDED|95.0|0.56|0.94||A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.|Log Rank|||||0.94|0.56|0.0165
71647245|NCT02627963|142811360|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8174|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||||1.25|0.75|0.8174
71762729|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-0.94||||0.4126|TWO_SIDED|90.0|-2.83|0.95|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.95|-2.83|0.4126
71647246|NCT01322633|142811363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.24|1.93||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.93|0.24|
71647247|NCT01322633|142811364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.65|1.4||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.40|0.65|
71647248|NCT01322633|142811365|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.21||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.||1.21|0.93|
71647249|NCT05109104|142811366|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
71647250|NCT05109104|142811366|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|25.0|||||TWO_SIDED|||||||||||||
71647251|NCT05109104|142811366|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|Labeled SPF|27.0|||||TWO_SIDED|||||||||||||
71660965|NCT03118570|142835406|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.115||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.115
71647252|NCT00323258|142811372|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the treatment arm compared to those who receive usual care."||||||0.5|||||||Chi-squared|||Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.||||.50
71647253|NCT00323258|142811373|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to combined beta-blocker and statin therapy in the treatment arm compared to those who receive usual care."|||||=|0.11|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||=0.11
71647254|NCT00323258|142811374|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to beta-blockers in the treatment arm compared to those who receive usual care."||||||0.03|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.03
71647255|NCT00323258|142811375|NON_INFERIORITY_OR_EQUIVALENCE|"Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are \>/= 75% adherent to statins in the treatment arm compared to those who receive usual care."||||||0.34|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.||||0.34
71647256|NCT01586039|142811378|SUPERIORITY|||||||0.73||||||Contrasting LED vs. CFL at 90 lux intensity|t-test, 2 sided|Paired t-test.||Contrasting LED vs. CFL at 90 lux intensity. Melatonin suppression is measured as the percentage of melatonin AUC relative to the AUC measured in dim light on the previous day. Higher values indicate more light-induced melatonin suppression.||||0.73
71647257|NCT01586039|142811378|SUPERIORITY|||||||0.001||||||Contrasting LED vs. CFL at 50 lux intensity|t-test, 2 sided|Paired t-test||Contrasting LED vs. CFL at 50 lux intensity||||0.001
71647258|NCT01586039|142811379|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Paired t-test||||||0.19
71647259|NCT01586039|142811381|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|Paired t-test.||||||0.17
71647260|NCT01586039|142811381|SUPERIORITY|||||||1|||||||t-test, 2 sided|Paired test.||||||1.0
71647261|NCT02442687|142811398|OTHER|||||||0.034||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.034
71647262|NCT02442687|142811398|OTHER|||||||0.1731||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1731
71647263|NCT02442687|142811399|OTHER|||||||0.5276||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.5276
71647264|NCT02442687|142811399|OTHER|||||||0.4968||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.4968
71647265|NCT02442687|142811400|OTHER|||||||0.2591||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2591
71647266|NCT02442687|142811400|OTHER|||||||0.1806||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.1806
71647267|NCT02442687|142811401|OTHER|||||||0.0882||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.0882
71647268|NCT02442687|142811401|OTHER|||||||0.253||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was \<0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.||||||0.2530
71647269|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2613|||||ONE_SIDED|95.0||0.31||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.31||
71647270|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.027|||||ONE_SIDED|95.0||0.0449||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0449||
71647271|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.1351|||||ONE_SIDED|95.0||0.1729||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1729||
71647272|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.1216|||||ONE_SIDED|95.0||0.1577||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.1577||
71647273|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0405|||||ONE_SIDED|95.0||0.0623||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0623||
71647274|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of anemia|0.2798|||||ONE_SIDED|95.0||0.3329||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.||0.3329||
71647275|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of nausea or hepatopathy|0.0052|||||ONE_SIDED|95.0||0.0137||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.||0.0137||
71647276|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of febrile neutropenia|0.0881|||||ONE_SIDED|95.0||0.1216||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.||0.1216||
71647277|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of platelet count decrease|0.3264|||||ONE_SIDED|95.0||0.3819||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.||0.3819||
71647278|NCT00354835|142811430|SUPERIORITY_OR_OTHER_LEGACY||The incidence of vomiting|0.0104|||||ONE_SIDED|95.0||0.0224||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.||0.0224||
71647279|NCT00354835|142811433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.||||0.99
71647280|NCT00354835|142811433|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED|95.0|||||Fisher Exact|||The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.||||0.036
71647281|NCT01968551|142811438|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA\<50 copies/mL at Week 24.|Difference in proportion|5.3||||0.23|TWO_SIDED|95.001|-3.4|17.4|||Fisher Exact||Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.|||17.4|-3.4|0.23
71647282|NCT01968551|142811439|NON_INFERIORITY_OR_EQUIVALENCE|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 48.|Difference in proportion|18.3||||0.004|TWO_SIDED|95.001|3.5|33.0|||Fisher Exact||Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|||33.0|3.5|0.004
71647283|NCT00431041|142811442|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71647284|NCT00431041|142811443|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value represents overall comparison of severity of dry mouth.|Chi-squared|||||||0.0010
71647285|NCT00573313|142811447|SUPERIORITY_OR_OTHER||Ratio of Geometric Means at 24 weeks.|0.1505|STANDARD_ERROR_OF_MEAN|0.1615||0.36|TWO_SIDED|95.0|-0.1853|0.4863||The data provided here are for changes in serum AST levels as representative of all clinical laboratory parameters measured.|ANCOVA|Analysis of covariance controlled for baseline data, e.g. AST.|Obtained median values and ranges and log transformations of SD.|Power calculation indicated that a sample size of 20 subjects per treatment arm would detect differences between groups of 0.9 within-subject standard deviations or higher at 80% power and 5% level of significance.||0.4863|-0.1853|0.36
71647286|NCT01597791|142811464|SUPERIORITY|||||||0.05||||||Calculated.|Fisher Exact|||||||.05
71647287|NCT02096705|142811467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.0968|<|0.0001|TWO_SIDED|95.0|-1.09|-0.71||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.71|-1.09|<0.0001
71647288|NCT02096705|142811468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.69|STANDARD_ERROR_OF_MEAN|4.605|<|0.0001|TWO_SIDED|95.0|-39.76|-21.61|||Longitudinal repeated measure analysis|P-value for Dapagliflozin vs. placebo|Difference of Dapagliflozin from placebo|||-21.61|-39.76|<0.0001
71647289|NCT02096705|142811469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3057|<|0.0001|TWO_SIDED|95.0|-1.98|-0.77||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.77|-1.98|<0.0001
71647290|NCT02096705|142811470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.5171||0.0059|TWO_SIDED|95.0|-2.45|-0.42||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo|||-0.42|-2.45|0.0059
71647291|NCT01874535|142811492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.009|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71647292|NCT03105297|142811559|SUPERIORITY|||||||0.0147||95.0||||p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment \& period as fixed effects, participants as random effects \& time as repeated measures effect.|ANCOVA|||||||0.0147
71647293|NCT03105297|142811560|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
71647294|NCT03105297|142811561|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided|||||||<0.0001
71824222|NCT02501811|143152049|OTHER||slope of time|-0.244|STANDARD_ERROR_OF_MEAN|0.158||0.126|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.126
71647295|NCT03105297|142811562|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||p-values are from a one sample t-test using SAS (Statistical Analysis System) UNIVARIATE on change from baseline.|t-test, 1 sided|||||||0.0073
71647296|NCT00714051|142811604|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Chi-squared|||The number of participants who fell on the tripping trial in each group were compared using Chi-square analysis||||0.45
71647297|NCT03868631|142811605|SUPERIORITY||||||<|0.05|||||||multilevel models for change|||Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p\<0.05.||||<0.05
71647298|NCT01929681|142811614|SUPERIORITY||||||<|0.049|||||||Regression, Linear|||||||<0.049
71647299|NCT01929681|142811615|SUPERIORITY||||||<|0.182|||||||Regression, Linear|||||||<0.182
71647300|NCT01929681|142811616|SUPERIORITY||||||<|0.449|||||||Regression, Linear|Mixed effects analysis||||||<0.449
71647301|NCT01929681|142811617|SUPERIORITY||||||<|0.444|||||||Regression, Linear|Mixed effects analysis||||||<0.444
71886413|NCT00848354|143293311|SUPERIORITY_OR_OTHER|||||||0.3054||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||||0.3054
71647302|NCT01929681|142811618|SUPERIORITY||||||<|0.182|||||||Regression, Linear|Mixed effects analysis||||||<0.182
71647303|NCT02452463|142811628|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|||||||0.107
71647304|NCT02452463|142811630|SUPERIORITY|||||||0.75|||||||Log Rank|||Null Hypotheses: OS distributions are equal||||0.75
71647305|NCT02452463|142811631|SUPERIORITY|||||||0.25|||||||Log Rank|||Null Hypotheses: PFS distributions are equal||||0.25
71647306|NCT02452463|142811632|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||||||0.131
71647307|NCT02452463|142811633|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||||||0.073
71647308|NCT02452463|142811634|SUPERIORITY|||||||0.616|||||||t-test, 2 sided|||||||0.616
71647309|NCT02452463|142811634|SUPERIORITY|||||||0.183|||||||Paired T-test|||Comparing change relative to baseline.||||0.183
71647310|NCT02452463|142811634|SUPERIORITY|||||||0.203|||||||paired T-test|||Evaluating change relative to baseline.||||0.203
71647311|NCT02452463|142811635|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.00
71647312|NCT05740098|142811637|SUPERIORITY||Odds Ratio (OR)|5.378|||<|0.001|TWO_SIDED|95.0|2.278|12.689|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||12.689|2.278|<0.001
71647313|NCT05740098|142811637|SUPERIORITY||Odds Ratio (OR)|3.668||||0.003|TWO_SIDED|95.0|1.538|8.747|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||8.747|1.538|0.003
71647314|NCT05740098|142811637|SUPERIORITY||Odds Ratio (OR)|0.682||||0.256|TWO_SIDED|95.0|0.352|1.321|||Mixed Models Analysis|||Analysis tested for significant main effects of treatment condition on 7-day point prevalence abstinence at 12- and 24-week assessments||1.321|0.352|0.256
71647315|NCT05740098|142811637|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on 7-day point prevalence abstinence at 12- and 24-week assessments||||<0.001
71647316|NCT05740098|142811638|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.365||0.287|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.287
71647317|NCT05740098|142811638|SUPERIORITY||Mean Difference (Final Values)|-0.597|STANDARD_ERROR_OF_MEAN|0.369||0.108|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.108
71647318|NCT05740098|142811638|SUPERIORITY||Mean Difference (Final Values)|-0.987|STANDARD_ERROR_OF_MEAN|0.361||0.007|TWO_SIDED||||||Mixed Models Analysis|||Analysis tested for significant main effect of treatment condition on Child Urine Cotinine||||0.007
71647319|NCT05740098|142811638|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||Analysis tested for significant main effect of time on Child Urine Cotinine||||0.878
71647320|NCT05740098|142811639|SUPERIORITY||Chi-Square Test Statistic|6.909||||0.009|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.009
71647321|NCT05740098|142811639|SUPERIORITY||Chi-Square Test Statistic|4.287||||0.038|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.038
71647322|NCT05740098|142811639|SUPERIORITY||Chi-Square Test Statistic|0.392||||0.531|TWO_SIDED||||||Chi-squared|Degrees of freedom = 1||Analysis tested for significant main effect of treatment condition on continuous abstinence at 24 weeks following quit date||||0.531
71647323|NCT05740098|142811640|SUPERIORITY||Chi-Square Test Statistic|3.859||||0.145|TWO_SIDED||||||Chi-squared|Degrees of freedom = 2||Analysis tested for significant main effect of treatment condition on 7-day point prevalence abstinence at 48-week follow-up||||0.145
71647324|NCT05740098|142811641|SUPERIORITY||Wald Chi-Square Test Statistic|1.454||||0.228|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 6-weeks following quit date adjusting for treatment condition.||||0.228
71647325|NCT05740098|142811641|SUPERIORITY||Wald Chi-Square Test Statistic|2.7||||0.1|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 12-weeks following quit date adjusting for treatment condition.||||0.10
71647326|NCT05740098|142811641|SUPERIORITY||Wald Chi-Square Test Statistic|3.202||||0.074|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 24-weeks following quit date adjusting for treatment condition.||||0.074
71647327|NCT05740098|142811641|SUPERIORITY||Wald Chi-Square Test Statistic|0.491||||0.484|TWO_SIDED||||||Regression, Logistic|||Analysis tested for significant main effect of baseline temporal discounting on point-prevalence abstinence at 48-weeks following quit date adjusting for treatment condition.||||0.484
71647328|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|1.063||||0.302|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 6-weeks following quit date||||0.302
71647329|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.788||||0.375|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 12-weeks following quit date||||0.375
71647330|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.08||||0.777|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 24-weeks following quit date||||0.777
71647331|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.006||||0.937|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Amplitude) and abstinence at 48-weeks following quit date||||0.937
71647332|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.172||||0.678|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 6-weeks following quit date||||0.678
71647333|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|7.99||||0.018|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant interaction between baseline price sensitivity (latent factor Persistence) and treatment condition for 6-week abstinence outcome||||0.018
71647334|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.177||||0.674|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 12-weeks following quit date||||0.674
71647335|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.646||||0.422|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 24-weeks following quit date||||0.422
71647336|NCT05740098|142811642|SUPERIORITY||Wald Chi-Square Test Statistic|0.038||||0.846|TWO_SIDED||||||Regression, Logistic|||The analysis tested for significant association between baseline price sensitivity (latent factor Persistence) and abstinence at 48-weeks following quit date||||0.846
71647337|NCT01073631|142811647|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|78.9|||||TWO_SIDED|95.0|75.07|82.73|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||82.73|75.07|
71647338|NCT01971554|142811696|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.8|||||TWO_SIDED|90.0|11.3|50.3|||||A constrained longitudinal data analysis (cLDA) model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||50.3|11.3|
71647339|NCT01971554|142811696|SUPERIORITY_OR_OTHER||Difference in the least squares means|36.0|||||TWO_SIDED|90.0|20.0|51.9|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||51.9|20.0|
71647340|NCT01971554|142811696|SUPERIORITY_OR_OTHER||Difference in the least squares means|54.1|||||TWO_SIDED|90.0|38.1|70.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||70.0|38.1|
71647341|NCT01971554|142811702|SUPERIORITY_OR_OTHER||Difference in the least squares means|22.3|||||TWO_SIDED|90.0|6.2|38.4|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||38.4|6.2|
71647342|NCT01971554|142811702|SUPERIORITY_OR_OTHER||Difference in the least squares means|30.6|||||TWO_SIDED|90.0|17.4|43.8|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||43.8|17.4|
71886414|NCT00848354|143293311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.4044|TWO_SIDED|95.0|0.58|7.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.53|0.58|0.4044
71647343|NCT01971554|142811702|SUPERIORITY_OR_OTHER||Difference in the least squares means|48.8|||||TWO_SIDED|90.0|35.6|62.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.|||62.0|35.6|
71647344|NCT01426854|142811705|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71647345|NCT03505151|142811707|OTHER||Ratio T/R|44.63|STANDARD_ERROR_OF_MEAN|36.9||||90.0|32.62|61.06|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Absolute bioavailability was evaluated using an Analysis of variance model (ANOVA) on BI 409306 AUC0-inf versus 0.1 mg BI 409306 C-13/N-15 i.v. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||61.06|32.62|
71647346|NCT03505151|142811708|OTHER||Ratio T/R|47.25|STANDARD_ERROR_OF_MEAN|68.8||||90.0|27.38|81.55|||||Standard Error of the mean is actually Intra-individual geometric coefficient of variation (gCV) of the mean|Ratios of BI 409306 for Cmax versus 0.1 mg BI 409306 C-13/N-15 i.v. was evaluated using ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed. The dose normalised PK endpoints were log transformed (natural logarithm) prior to fitting the ANOVA model.||81.55|27.38|
71647347|NCT00950300|142811714|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.|Geometric mean ratio|1.33|||||TWO_SIDED|90.0|1.24|1.44|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (\>) 5%.||1.44|1.24|
71647348|NCT00950300|142811715|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.|Difference in response rates|4.7|||||ONE_SIDED|97.5|-4.0||||||The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.|Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.|||-4.0|
71647349|NCT00950300|142811716|OTHER||Geometric mean ratio|1.51|||||TWO_SIDED|90.0|1.4|1.63|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.63|1.40|
71647350|NCT00950300|142811717|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.46|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.46|
71647351|NCT00950300|142811718|OTHER||Geometric mean ratio|1.55|||||TWO_SIDED|90.0|1.45|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.||1.64|1.45|
71647352|NCT00950300|142811727|OTHER||Difference in response rates|5.01|||||TWO_SIDED|95.0|-3.5|13.5|||||The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.|||13.5|-3.5|
71647353|NCT00950300|142811728|OTHER||Difference in response rates|-1.64|||||TWO_SIDED|95.0|-7.4|4.2|||||The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.|||4.2|-7.4|
71647354|NCT00950300|142811728|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.5|1.46|||||OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.46|0.50|
71647355|NCT00950300|142811731|OTHER||Hazard Ratio (HR)|0.98||||0.8651|TWO_SIDED|95.0|0.74|1.29|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.29|0.74|0.8651
71647356|NCT00950300|142811733|OTHER||Hazard Ratio (HR)|0.94||||0.7767|TWO_SIDED|95.0|0.61|1.45|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|||1.45|0.61|0.7767
71647357|NCT00494013|142811736|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.4%.|Mean Difference (Net)|-0.21||||0.026||95.0|-0.39|-0.03|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).||-0.03|-0.39|0.026
71647358|NCT00494013|142811737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
71647359|NCT00494013|142811737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||0.06|-0.28|0.213
71647360|NCT00494013|142811737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
71660966|NCT03118570|142835406|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.356||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.356
71647361|NCT00494013|142811737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).|||-0.01|-0.38|0.038
71647362|NCT00494013|142811738|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.463
71647363|NCT00494013|142811738|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.135
71647364|NCT00494013|142811739|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per Liter (mmol/L).|Mean Difference (Net)|0.1||||0.107||95.0|-0.02|0.23|||ANOVA|ANOVA model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The first gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to determir.||0.23|-0.02|0.107
71647365|NCT00494013|142811740|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||P-value for Average 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.952
71647366|NCT00494013|142811740|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||P-value for Average Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.856
71647367|NCT00494013|142811740|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Average Post-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.790
71647368|NCT00494013|142811740|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for Average Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.632
71647369|NCT00494013|142811741|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for All Hypoglycemic Events.|Fisher Exact|||||||0.472
71647370|NCT00494013|142811741|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Nocturnal Hypoglycemic Events.|Fisher Exact|||||||0.005
71647371|NCT00494013|142811741|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value for Severe Hypoglycemic Events.|Fisher Exact|||||||0.450
71647372|NCT00494013|142811742|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
71647373|NCT00494013|142811742|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.001
71647374|NCT00494013|142811742|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.226
71647375|NCT00494013|142811744|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|1.5|||<|0.001||95.0|0.93|2.06||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The second gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to detemir with regard to change in absolute body weight from baseline to endpoint (last observation carried forward).||2.06|0.93|<0.001
71647376|NCT00494013|142811745|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.074
71647377|NCT00494013|142811746|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.039
71647378|NCT00494013|142811747|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Fisher Exact|||||||0.026
71647379|NCT00919711|142811751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.6|||<|0.0001|TWO_SIDED|95.0|1.2|2.0|||ANCOVA||Denosumab - Risedronate|||2.0|1.2|<0.0001
71647380|NCT00919711|142811752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71647381|NCT00919711|142811753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|0.9|1.8|||ANCOVA||Denosumab - Risedronate|||1.8|0.9|<0.0001
71647382|NCT00919711|142811754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.8|2.8|||ANCOVA||Denosumab - Risedronate|||2.8|1.8|<0.0001
71647383|NCT02488109|142811794|OTHER|||||||0.42||||||Changes in rates of clinical remission by group over time in the mITT model.|Regression, Linear|Clinical remission was modeled as a nominal multinomial outcome (yes, no, or missing)||The study was powered to detect a difference in 12-months clinical remission rates between groups. N = 60 per arm with 85% retention would provide 80% power on a 2-sided 0.05-level test to detect a 20% difference between groups in 12-months clinical remission rates. A generalized linear mixed-effects regression model was used to compare study arms with respect to achievement and maintenance of clinical remission.||||0.42
71647384|NCT02488109|142811795|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.01|TWO_SIDED|95.0|1.1|2.53||Survival analysis of time to medical stability by log-rank test, which does not assume proportional hazards. Those who did not reach medical stability before hospital discharge were censored; analyses accounted for the site effect by stratification.|Survival analysis with log rank test|Compared time to achieve medical stability by arm; participants who did not meet stability criteria by hospital discharge were right-censored||This trial was powered at 0.80 to detect a 12% to 20% difference in restored medical stability at 0.05 type I error and correlation between time points from 0.1 to 1.||2.53|1.10|0.01
71647385|NCT02488109|142811796|SUPERIORITY||Median Difference (Net)|19.0||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Cost outcomes of group differences and 95% confidence intervals were estimated.||28,819|9,293|0.002
71647386|NCT03969641|142811797|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 (1-sided) and a noninferiority margin of 10%.|Difference in Proportions (RIV4 - IIV4)|-0.0214|||<|0.0001|ONE_SIDED|97.5||0.0406|||Cochran-Mantel-Haenszel|The upper bound of a Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used, stratified by site.|The directional comparison was the upper bound of the confidence interval using a 10% noninferiority margin.|The null hypothesis assumes that RIV4 is inferior (i.e., RIV4 will have a higher proportion) to IIV4 in regards to the proportion of pregnant women with adverse birth outcomes.||0.0406||<0.0001
71647387|NCT03969641|142811798|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of preterm birth was also calculated.|Odds Ratio (OR)|0.72||||0.4645|TWO_SIDED|95.0|0.35|1.48|||Mantel Haenszel|||Preterm birth||1.48|0.35|0.4645
71647388|NCT03969641|142811799|SUPERIORITY|These proportions were compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportions of combined fetal death and neonatal death was also calculated.|Odds Ratio (OR)|0.00000031||||0.2447|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Fetal or neonatal death|||0.00|0.2447
71647389|NCT03969641|142811800|SUPERIORITY|This proportion was compared between the RIV4 group and the IIV4 group using an exact Mantel-Haenszel statistic in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level. The site adjusted odds ratio and corresponding 95% confidence interval for the proportion of spontaneous abortion after vaccination was also calculated. This was a subgroup analysis of only those participants vaccinated at less than 20 weeks gestational age.|Odds Ratio (OR)|0.5||||0.6235|TWO_SIDED|95.0|0.04|5.47|||Mantel Haenszel|||Spontaneous abortion||5.47|0.04|0.6235
71647390|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.17||||0.7029|TWO_SIDED|95.0|0.55|2.5|||Mantel Haenszel|||Injection Site Pain||2.50|0.55|0.7029
71647391|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|2.03||||0.6217|TWO_SIDED|95.0|0.18|22.52|||Mantel Haenszel|||Injection Site Redness||22.52|0.18|0.6217
71647392|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.7||||0.3848|TWO_SIDED|95.0|0.35|1.39|||Mantel Haenszel|||Injection Site Tenderness||1.39|0.35|0.3848
71647393|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.2504|TWO_SIDED|95.0|0.21|1.35|||Mantel Haenszel|||Nausea||1.35|0.21|0.2504
71647394|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.62||||0.5751|TWO_SIDED|95.0|0.2|1.93|||Mantel Haenszel|||Vomiting||1.93|0.20|0.5751
71647395|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.32|3.19|||Mantel Haenszel|||Diarrhea||3.19|0.32|1.0000
71647396|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.8||||1|TWO_SIDED|95.0|0.21|3.04|||Mantel Haenszel|||Abdominal Pain||3.04|0.21|1.0000
71647397|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.53||||0.1326|TWO_SIDED|95.0|0.25|1.13|||Mantel Haenszel|||Headache||1.13|0.25|0.1326
71647398|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|1.01||||1|TWO_SIDED|95.0|0.2|5.04|||Mantel Haenszel|||Chills/Shivering||5.04|0.20|1.0000
71647399|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0||The upper limit of this CI is infinity, thus no numeric value can be provided.||Mantel Haenszel|||Body Rash|||0.00|1.0000
71702442|NCT01482221|142921886|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|1.238||0.889|TWO_SIDED|95.0|-2.609|2.264||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.264|-2.609|0.889
71824223|NCT02501811|143152050|OTHER||slope of time|-0.42|STANDARD_ERROR_OF_MEAN|0.281||0.139|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.139
71647400|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.92||||1|TWO_SIDED|95.0|0.39|2.15|||Mantel Haenszel|||Malaise (Fatigue)||2.15|0.39|1.0000
71647401|NCT03969641|142811801|SUPERIORITY|These proportions will be compared between the RIV4 group and the IIV4 group, within symptom, using an exact Mantel-Haenszel statistic (calculated in Proc Logistic in SAS) in a stratified analysis by site to control for the randomization blocks at the two-sided alpha 0.05 level.|Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.31|2.48|||Mantel Haenszel|||Myalgia (Body Aches)||2.48|0.31|1.0000
71647402|NCT03969641|142811801|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7704|TWO_SIDED|95.0|0.22|2.29|||Mantel Haenszel|||Joint Pain||2.29|0.22|0.7704
71647403|NCT01541215|142811802|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: change from baseline to week 26 in HbA1c~Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%."|Treatment difference|-1.058|STANDARD_ERROR_OF_MEAN|0.304|<|0.001|TWO_SIDED|95.0|-1.653|-0.464|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.464|-1.653|<0.001
71647404|NCT01541215|142811803|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Change from baseline in FPG after 26 weeks of treatment"|Treatment difference|-1.878|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-3.093|-0.662|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||-0.662|-3.093|0.002
71647405|NCT01541215|142811804|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: HbA1c \< 7.0% after 26 weeks of treatment"|Treatment odds ratio|5.353|||<|0.001|TWO_SIDED|95.0|2.105|13.615|||logistic regression model|||Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender\*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.||13.615|2.105|<0.001
71647406|NCT01541215|142811805|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Change from baseline in BMI SDS after 26 weeks of treatment"|Treatment difference|-0.047|STANDARD_ERROR_OF_MEAN|0.055||0.392|TWO_SIDED|95.0|-0.153|0.06|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.||0.060|-0.153|0.392
71647407|NCT02466087|142811898|OTHER||diiference in differences|1.5|||||TWO_SIDED|95.0|||||Regression, Linear|||||||
71647408|NCT02725515|142811970|SUPERIORITY||Risk Difference (RD)|13.4||||0.183|TWO_SIDED|95.0|-6.6|32.6|||Barnard's Unconditional Exact Test P-val|||||32.6|-6.6|0.1830
71647409|NCT02725515|142811971|SUPERIORITY||Risk Difference (RD)|17.5||||0.1075|TWO_SIDED|95.0|-3.7|37.3|||Barnard's Unconditional Exact Test P-val|||||37.3|-3.7|0.1075
71647410|NCT02725515|142811972|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0252|TWO_SIDED|95.0|0.3|0.92|||Log Rank|||||0.92|0.30|0.0252
71647411|NCT02898740|142811988|OTHER||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-6.8|0.0|||Mixed Models Analysis|models were adjusted for age|treatment difference = Exercise - Health Education|||-0.0|-6.8|<0.05
71647412|NCT02856594|142812041|SUPERIORITY||Odds Ratio (OR)|0.32||||0.029|TWO_SIDED|95.0|0.1|0.83|||Regression, Logistic|||||0.83|0.10|0.029
71647413|NCT02856594|142812043|SUPERIORITY||Odds Ratio (OR)|0.96||||0.24|TWO_SIDED|95.0|0.89|1.03|||Regression, Linear|||||1.03|0.89|0.24
71647414|NCT01884844|142812054|SUPERIORITY|||||||0.89|||||||Fisher Exact|||||||0.89
71647415|NCT02906917|142812062|NON_INFERIORITY|Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.|Treatment contrast|0.07|||<|0.0001|TWO_SIDED|95.0|-0.06|0.21||One-sided p-value for test of non-inferiority.|ANCOVA|Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.||The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).||0.21|-0.06|<0.0001
71647416|NCT00874822|142812116|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|19.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|13.6|24.4|||Chi-squared, Corrected|||"Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163."||24.4|13.6|<0.0001
71762730|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-1.17||||0.3085|TWO_SIDED|90.0|-3.06|0.72|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.72|-3.06|0.3085
71647417|NCT05053360|142812152|SUPERIORITY||Odds Ratio (OR)|2.87||||0.019|TWO_SIDED|95.0|1.19|6.93|||Regression, Logistic|||HIGH PAIN = score over 6 on a 0-10 pain scale (higher number indicating higher pain)||6.93|1.19|.019
71647418|NCT05053360|142812153|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.0002|TWO_SIDED|95.0|-3.47|-1.09|||ANCOVA|||||-1.09|-3.47|.0002
71647419|NCT03807440|142812166|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71647420|NCT03807440|142812167|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647421|NCT03807440|142812168|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71647422|NCT03807440|142812169|OTHER|||||||0.8071|||||||Chi-squared|||||||0.8071
71647423|NCT03807440|142812169|OTHER|||||||0.764|||||||Fisher Exact|||||||0.7640
71647424|NCT03807440|142812170|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71647425|NCT03807440|142812171|OTHER|||||||0.0042|||||||Chi-squared|||||||0.0042
71647426|NCT03807440|142812172|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71647427|NCT03807440|142812173|OTHER|||||||0.399|||||||Chi-squared|||||||0.3990
71647428|NCT03807440|142812173|OTHER|||||||0.3842|||||||Fisher Exact|||||||0.3842
71647429|NCT03807440|142812174|OTHER|||||||0.0605|||||||Kruskal-Wallis|||||||0.0605
71647430|NCT03807440|142812175|OTHER|||||||0.6329|||||||Chi-squared|||||||0.6329
71647431|NCT03807440|142812175|OTHER|||||||0.7181|||||||Fisher Exact|||||||0.7181
71647432|NCT03807440|142812176|OTHER|||||||0.5233|||||||Kruskal-Wallis|||||||0.5233
71647433|NCT03807440|142812178|OTHER|||||||0.3662|||||||Kruskal-Wallis|||||||0.3662
71647434|NCT03807440|142812179|OTHER|||||||0.511|||||||Kruskal-Wallis|||||||0.5110
71647435|NCT03807440|142812180|OTHER|||||||0.0921|||||||Kruskal-Wallis|||||||0.0921
71647436|NCT03807440|142812181|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71647437|NCT03807440|142812182|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647438|NCT03807440|142812183|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<.0001
71647439|NCT03807440|142812184|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647440|NCT03807440|142812185|OTHER|||||||0.3201|||||||Kruskal-Wallis|||||||0.3201
71647441|NCT03807440|142812186|OTHER|||||||0.3288|||||||Chi-squared|||||||0.3288
71647442|NCT03807440|142812186|OTHER|||||||0.171|||||||Fisher Exact|||||||0.1710
71647443|NCT03807440|142812187|OTHER|||||||0.013|||||||Kruskal-Wallis|||||||0.0130
71647444|NCT03807440|142812188|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
71647445|NCT03807440|142812189|OTHER|||||||0.3978|||||||Kruskal-Wallis|||||||0.3978
71647446|NCT03807440|142812190|OTHER|||||||0.0055|||||||Chi-squared|||||||0.0055
71647447|NCT03807440|142812190|OTHER|||||||0.0041|||||||Fisher Exact|||||||0.0041
71647448|NCT03807440|142812191|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647449|NCT03807440|142812192|OTHER|||||||0.0399|||||||Chi-squared|||||||0.0399
71647450|NCT03807440|142812192|OTHER|||||||0.0401|||||||Fisher Exact|||||||0.0401
71647451|NCT03807440|142812210|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647452|NCT03807440|142812211|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647453|NCT03807440|142812212|OTHER|||||||0.0008|||||||Chi-squared|||||||0.0008
71647454|NCT03807440|142812214|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647455|NCT03807440|142812215|OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
71647456|NCT03807440|142812216|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647457|NCT03807440|142812217|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647458|NCT03807440|142812218|OTHER|||||||0.9184|||||||Chi-squared|||||||0.9184
71647459|NCT03807440|142812218|OTHER|||||||0.9911|||||||Fisher Exact|||||||0.9911
71647460|NCT03807440|142812219|OTHER|||||||0.6967|||||||Chi-squared|||||||0.6967
71647461|NCT03807440|142812219|OTHER|||||||0.6439|||||||Fisher Exact|||||||0.6439
71647462|NCT03807440|142812220|OTHER|||||||0.9414|||||||Chi-squared|||||||0.9414
71647463|NCT03807440|142812220|OTHER|||||||0.8142|||||||Fisher Exact|||||||0.8142
71647464|NCT03807440|142812221|OTHER|||||||0.7837|||||||Chi-squared|||||||0.7837
71647465|NCT03807440|142812221|OTHER|||||||0.7538|||||||Fisher Exact|||||||0.7538
71647466|NCT03807440|142812222|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
71647467|NCT03807440|142812223|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647468|NCT03807440|142812224|OTHER|||||||0.1906|||||||Chi-squared|||||||0.1906
71647469|NCT03807440|142812225|OTHER|||||||0.6198|||||||Chi-squared|||||||0.6198
71647470|NCT03807440|142812225|OTHER|||||||0.7297|||||||Fisher Exact|||||||0.7297
71647471|NCT03807440|142812227|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647472|NCT03807440|142812228|OTHER|||||||0.0012|||||||Chi-squared|||||||0.0012
71647473|NCT03807440|142812228|OTHER|||||||0.0002|||||||Fisher Exact|||||||0.0002
71647474|NCT03807440|142812229|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71647475|NCT03807440|142812232|OTHER|||||||0.003|||||||Log Rank|||||||0.0030
71647476|NCT01728636|142812300|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
71647477|NCT03405363|142812306|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.2|||||TWO_SIDED|95.0|0.98|1.47|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|||1.47|0.98|
71647478|NCT03405363|142812307|OTHER||Adjusted Incidence Rate Ratio|1.83|||||TWO_SIDED|95.0|0.9|3.74|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||3.74|0.90|
71647479|NCT03405363|142812308|OTHER||Adjusted Incidence Rate Ratio|1.3|||||TWO_SIDED|95.0|0.71|2.36|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||2.36|0.71|
71647480|NCT03405363|142812309|OTHER||Adjusted Incidence Rate Ratio|1.22|||||TWO_SIDED|95.0|0.79|1.87|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.87|0.79|
71647481|NCT03405363|142812310|OTHER||Adjusted Incidence Rate Ratio|1.0|||||TWO_SIDED|95.0|0.64|1.56|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|No formal hypotheses were tested.||1.56|0.64|
71647482|NCT03405363|142812311|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.63|||||TWO_SIDED|95.0|1.44|1.84|||Poisson regression model|Including exposure, natural logarithm of person-years at risk as offset, propensity score quintiles, and LAMA use at the index date as a covariate.|Olodaterol compared to 'other LABA' as reference|Analysis was based on Propensity score-trimmed population of patients with Chronic Obstructive Pulmonary Disease (COPD) derived from the Danish Patient Registry.||1.84|1.44|
71824224|NCT02501811|143152051|OTHER||slope of time|-0.133|STANDARD_ERROR_OF_MEAN|0.184||0.472|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.472
71647483|NCT03405363|142812311|OTHER|No formal hypotheses were tested.|Adjusted Incidence Rate Ratio|1.48|||||TWO_SIDED|95.0|1.23|1.78|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|"Analysis based on post-hoc population 1.~Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications, fixed-dose combinations of Short-Acting Beta2- Agonist and Short-Acting Muscarinic Antagonist and systemic antibacterials. COPD severity, number of: all-cause hospitalisations 365 and 180 days, COPD exacerbations 180 and 90 days, COPD hospitalisations 180 and 90 days, and COPD exacerbations 90 days before index date."||1.78|1.23|
71647484|NCT03405363|142812311|OTHER|No formal hypotheses were tested.|Adjusted Incidende Rate Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||Poisson regression model||Olodaterol compared to 'other LABA' as reference|Analysis based on post-hoc population 2. Adjustments: propensity score decile, previous use of: LAMA, oxygen, inhaled glucocorticoid, respiratory medications. COPD severity, number of all-cause hospitalisations 180 days, COPD exacerbations 180 days before cohort entry.||1.64|0.97|
71647485|NCT02533466|142812312|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|-0.08||||0.2673|TWO_SIDED|95.0|-1.0|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.0|0.2673
71647486|NCT02533466|142812313|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-0.92||||0.069|TWO_SIDED|95.0|-1.8|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum Test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-1.8|0.0690
71647487|NCT02533466|142812314|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.5||||0.068|TWO_SIDED|95.0|-2.7|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."|||0.0|-2.7|0.0680
71647488|NCT02533466|142812315|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.83||||0.0654|TWO_SIDED|95.0|-3.0|0.0||P-value is calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test.||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product"|||0.0|-3.0|0.0654
71647489|NCT02533466|142812316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-1.4||||0.6061|TWO_SIDED|95.0|-6.8|4.1||P value obtained from the ANCOVA analysis|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||4.1|-6.8|0.6061
71647490|NCT02533466|142812317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-2.3||||0.408|TWO_SIDED|95.0|-7.9|3.3||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product|||3.3|-7.9|0.4080
71647491|NCT02533466|142812318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|0.21||||0.4611|TWO_SIDED|95.0|-0.4|0.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||0.8|-0.4|0.4611
71647492|NCT02533466|142812319|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Net)|0.09||||0.3939|TWO_SIDED|95.0|-0.1|0.3||P value obtained from the ANCOVA analysis.|ANCOVA|||||0.3|-0.1|0.3939
71647493|NCT02533466|142812320|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|0.34||||0.7829|TWO_SIDED|95.0|-2.2|2.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||2.8|-2.2|0.7829
71647494|NCT02533466|142812321|NON_INFERIORITY_OR_EQUIVALENCE|Equivalent analyses was executed using scale transformation or non-parametric methods|Mean Difference (Final Values)|-0.08||||0.9121|TWO_SIDED|95.0|-1.6|1.4||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.|||1.4|-1.6|0.9121
71824225|NCT02501811|143152052|OTHER||slope of time|6.544|STANDARD_ERROR_OF_MEAN|2.882||0.025|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.025
71647495|NCT01196390|142812322|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.85|TWO_SIDED|95.0|0.69|1.36|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.||1.36|0.69|0.85
71647496|NCT01196390|142812323|SUPERIORITY|||||||0.71|||||||Chi-squared|Two-sided significance level = 0.05||||||0.71
71647497|NCT01196390|142812324|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.69|1.47|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation arm|||1.47|0.69|0.95
71647498|NCT01196390|142812326|SUPERIORITY|||||||0.39||||||One-side significance level = 0.05|Chi-squared|||6-8 weeks||||0.39
71647499|NCT01196390|142812326|SUPERIORITY|||||||0.78||||||One-side significance level = 0.05|Chi-squared|||1 year||||0.78
71647500|NCT01196390|142812326|SUPERIORITY|||||||0.28||||||One-side significance level = 0.05|Chi-squared|||2 years||||0.28
71647501|NCT01196390|142812329|SUPERIORITY||Odds Ratio (OR)|2.35||||0.021|TWO_SIDED|95.0|1.13|4.86|||Regression, Logistic|||Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \[reference level(RL)\]), T stage (T3 vs.T1,T2 \[RL\]), Zubrod (1,2 vs. 0 \[RL\]), gender (male vs. female \[RL\]), presence of adenopathy (yes vs. no \[RL\]), and age (≥ 60 vs. \<60 \[RL\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.||4.86|1.13|0.021
71647502|NCT01949532|142812341|SUPERIORITY_OR_OTHER||Ratio of geometric means|132.75|||||TWO_SIDED|90.0|70.6|249.63|||||The point estimates of the geometric mean ratios for the PK parameters were calculated by exponentiation of the differences in the least-squares means between the renal impairment group (test) and participants with normal renal function (reference).|||249.63|70.60|
71647503|NCT01949532|142812342|SUPERIORITY_OR_OTHER||Ratio of geometric means|133.62|||||TWO_SIDED|90.0|70.93|251.73||||||||251.73|70.93|
71647504|NCT03790137|142812379|OTHER|The frequency of HWE for each patient was reported as episodes/day, as determined by dividing the total number of seizures experienced over a given time period by the number of days for which seizures were recorded. Paired t-tests were performed to compare each patient's baseline seizure frequency to their seizure frequency in the last month of treatment. Change in seizure frequency is reported as percent change from baseline. An alpha of 0.05 was used for statistical significance.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71762731|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-0.99||||0.3889|TWO_SIDED|90.0|-2.88|0.9|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.88|0.3889
71824226|NCT02501811|143152053|OTHER||slope with interaction|-7.08|STANDARD_ERROR_OF_MEAN|3.3||0.037|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.037
71886415|NCT00848354|143293311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0388|TWO_SIDED|95.0|1.02|6.26||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||6.26|1.02|0.0388
71647505|NCT01942135|142812424|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.422|||<|1e-06|TWO_SIDED|95.0|0.318|0.56||The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance was 0.00135.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||0.560|0.318|<0.000001
71647506|NCT01942135|142812426|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.814|||=|0.0429|TWO_SIDED|95.0|0.644|1.029||1-sided p-value from the log-rank test stratified by the presence of visceral metastases and sensitivity to prior endocrine therapy per randomization.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib plus fulvestrant.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ\<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.||1.029|0.644|=0.0429
71647507|NCT01942135|142812428|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.783||||0.0001|TWO_SIDED|95.0|1.563|5.603||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An Odds Ratio \>1 means better response in favor of the palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||5.603|1.563|0.0001
71660967|NCT03118570|142835406|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.205||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.205
71660968|NCT03118570|142835406|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.078
71647508|NCT01942135|142812430|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.016|||<|0.0001|TWO_SIDED|95.0|2.046|4.565||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An odds ratio \> 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio \>1 means better response in favor of palbociclib plus fulvestrant arm.||4.565|2.046|<0.0001
71647509|NCT01942135|142812434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.0313|TWO_SIDED|95.0|0.3|6.0||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL||6.0|0.3|0.0313
71647510|NCT01942135|142812434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.4|TWO_SIDED|95.0|-1.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning||3.5|-1.4|0.4000
71647511|NCT01942135|142812434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.2615|TWO_SIDED|95.0|-1.5|5.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning||5.3|-1.5|0.2615
71647512|NCT01942135|142812434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.0016|TWO_SIDED|95.0|1.7|7.4||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning||7.4|1.7|0.0016
71647513|NCT01942135|142812434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.365|TWO_SIDED|95.0|-1.4|3.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning||3.8|-1.4|0.3650
71647514|NCT01942135|142812434|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9615|TWO_SIDED|95.0|-3.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning||3.5|-3.4|0.9615
71647515|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.32|TWO_SIDED|95.0|-4.5|1.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue||1.5|-4.5|0.3200
71647516|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0369|TWO_SIDED|95.0|-4.8|-0.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting||-0.2|-4.8|0.0369
71647517|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3||||0.0011|TWO_SIDED|95.0|-8.5|-2.1||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain||-2.1|-8.5|0.0011
71647518|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7699|TWO_SIDED|95.0|-3.7|2.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea||2.8|-3.7|0.7699
71660969|NCT03118570|142835407|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.037||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.037
71824227|NCT02501811|143152053|OTHER||slope with interaction|-6.78|STANDARD_ERROR_OF_MEAN|3.18||0.035|TWO_SIDED||||||Regression, Linear|||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. A time by treatment interaction was assessed.||||0.035
71824228|NCT02501811|143152054|OTHER||slope of time|84.557|STANDARD_ERROR_OF_MEAN|35.81||0.092|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase II trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the 4 treatment groups. Results of the overall model are reported.||||0.092
71647519|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.2721|TWO_SIDED|95.0|-5.5|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia||1.6|-5.5|0.2721
71647520|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.7334|TWO_SIDED|95.0|-4.1|2.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss||2.9|-4.1|0.7334
71647521|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.6491|TWO_SIDED|95.0|-2.5|3.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation||3.9|-2.5|0.6491
71647522|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.6293|TWO_SIDED|95.0|-2.8|1.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea||1.7|-2.8|0.6293
71647523|NCT01942135|142812435|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.8812|TWO_SIDED|95.0|-3.1|3.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties||3.6|-3.1|0.8812
71647524|NCT01942135|142812436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.1386|TWO_SIDED|95.0|-0.7|5.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for body image||5.2|-0.7|0.1386
71647525|NCT01942135|142812436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.5235|TWO_SIDED|95.0|-3.1|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual functioning||1.6|-3.1|0.5235
71647526|NCT01942135|142812436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.6271|TWO_SIDED|95.0|-4.4|7.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual enjoyment||7.3|-4.4|0.6271
71647527|NCT01942135|142812436|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.0845|TWO_SIDED|95.0|-0.5|7.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for future perspective||7.6|-0.5|0.0845
71647528|NCT01942135|142812437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.7273|TWO_SIDED|95.0|-1.6|2.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects||2.3|-1.6|0.7273
71647529|NCT01942135|142812437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.2671|TWO_SIDED|95.0|-2.6|0.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms||0.7|-2.6|0.2671
71660970|NCT03118570|142835407|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.342||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.342
71824229|NCT02857283|143152091|SUPERIORITY|||||||0.46|||||||ANOVA|paired||||||0.46
71824230|NCT02857283|143152092|SUPERIORITY|||||||0.0481|||||||ANOVA|Paired||||||0.0481
71824231|NCT02857283|143152093|SUPERIORITY|||||||0.0179|||||||ANOVA|||||||0.0179
71824232|NCT02857283|143152094|SUPERIORITY|||||||0.1|||||||ANOVA|paired||||||0.10
71824233|NCT02857283|143152095|SUPERIORITY|||||||0.69|||||||ANOVA|paired||||||0.69
71824234|NCT02857283|143152096|SUPERIORITY|||||||0.27|||||||ANOVA|paired||||||0.27
71824235|NCT02857283|143152097|SUPERIORITY|||||||0.5|||||||ANOVA|paired||||||0.50
71824236|NCT02857283|143152098|SUPERIORITY|||||||0.54|||||||Wilcoxon signed rank test|||||||0.54
71647530|NCT01942135|142812437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.875|TWO_SIDED|95.0|-2.6|2.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms||2.2|-2.6|0.8750
71647531|NCT01942135|142812437|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.0255|TWO_SIDED|95.0|1.1|16.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss||16.6|1.1|0.0255
71647532|NCT01942135|142812438|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.037||||0.0308|TWO_SIDED|95.0|0.0|0.07||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.07|0.00|0.0308
71647533|NCT01942135|142812439|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.5523|TWO_SIDED|95.0|-1.9|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.5|-1.9|0.5523
71647534|NCT01942135|142812440|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.642|||<|0.001|TWO_SIDED|95.0|0.487|0.846||The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.|Unstratified log-rank test (1-sided)|1-sided p-value from the unstratified log-rank test.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.||0.846|0.487|<0.001
71647535|NCT00087529|142812445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.773||||0.1442|TWO_SIDED|95.0|0.546|1.093||Stratified using the following variables: Baseline EDSS (less than or equal to \[≤\] 4.0 versus \>4.0 points) and prior treatment with interferon-beta or glatiramer acetate.|Log Rank|||||1.093|0.546|0.1442
71647536|NCT00087529|142812447|SUPERIORITY_OR_OTHER||LS mean difference|-718.24||||0.0008|TWO_SIDED|95.0|-1504.48|68.0|||Friedman ranked ANOVA test|||Treatment difference in least-squares (LS) means and the associated 95% confidence intervals were estimated from the analysis of variance (ANOVA) model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||68.00|-1504.48|0.0008
71647537|NCT00087529|142812448|SUPERIORITY_OR_OTHER||LS mean difference|-1.08||||0.6237|TWO_SIDED|95.0|-9.49|7.34|||Friedman ranked ANOVA test|||Treatment difference in LS means and the associated 95% confidence intervals were estimated from the ANOVA model, which included the following factors: Baseline EDSS (≤ 4.0 versus \>4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.||7.34|-9.49|0.6237
71647538|NCT00202839|142812476|SUPERIORITY_OR_OTHER|||||||0.1651||95.0|||||Chi-squared|||||||0.1651
71647539|NCT01863186|142812495|SUPERIORITY|||||||0.0166|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0166
71647540|NCT01863186|142812495|SUPERIORITY|||||||0.0033|||||||Pattern Mixture Model|||Due to the amount of missing data a pattern mixture model (or Jump to Reference) was utilized. The SOWS-Gossop total scores were log transformed. Each subjects available data Days 1-7 were included. The datasets created by the pattern mixture model were analyzed using a Mixed Model Repeated Measures model that included fixed effects for treatment group, baseline, sex, study day (1-7), and treatment group-by-day interaction. The overall estimate for each treatment group were compared.||||0.0033
71647541|NCT00452348|142812526|SUPERIORITY_OR_OTHER||Least Squares Mean|0.04||||0.09||95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.090
71647542|NCT00377156|142812597|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-28.2|||<|0.001|TWO_SIDED|90.0|-41.9|-14.4|||Fisher Exact||Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 \[63.5%\] vs 44/48 \[91.7%\],\> respectively. The percent difference was -28.2%; 90% CI, -41.9% to -14.4%; P \< .001).|||-14.4|-41.9|<0.001
71647543|NCT00377156|142812598|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-18.4|||<|0.001|TWO_SIDED|95.0|-29.0|-7.8|||Fisher Exact|||||-7.8|-29.0|<0.001
71647544|NCT00377156|142812599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.9||||0.001|TWO_SIDED|95.0|4.8|19.0|||t-test, 2 sided|||||19.0|4.8|0.001
71647545|NCT00377156|142812600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.4||||0.04|TWO_SIDED|95.0|-74.4|5.5|||Fisher Exact||The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 \[60%\] vs 17/18 \[94.4%\]. The percent difference was -34.4% (95% CI: -74.4% to 5.5%; P = .04)|||5.5|-74.4|0.04
71762732|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-0.57||||0.6192|TWO_SIDED|90.0|-2.46|1.32|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.32|-2.46|0.6192
71824237|NCT02857283|143152099|SUPERIORITY|||||||0.9|||||||ANOVA|paired||||||0.90
71824238|NCT02857283|143152101|SUPERIORITY|||||||0.64|||||||Wilcoxon signed rank test|||||||0.64
71647546|NCT00377156|142812601|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Regression, Cox|||||1.38|0.75|0.92
71647547|NCT00856349|142812602|SUPERIORITY_OR_OTHER||Increase in % on target (LIA)|13.6|||<|0.0001|||||||McNemar|||LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.||||<0.0001
71647548|NCT00856349|142812602|SUPERIORITY_OR_OTHER||Increase in % on target (SVT Limit)|6.8|||<|0.0001|||||||McNemar|||SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.||||<0.0001
71647549|NCT00856349|142812602|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID PP)|9.0|||<|0.0001|||||||McNemar|||VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.||||<0.0001
71647550|NCT00856349|142812602|SUPERIORITY_OR_OTHER||Increase in % on target (VF NID SP)|3.5||||0.0116|||||||McNemar|||VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.||||0.0116
71647551|NCT00856349|142812602|SUPERIORITY_OR_OTHER||Increase in % on target (Wavelet)|9.5|||<|0.0001|||||||McNemar|||Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.||||<0.0001
71647552|NCT00856349|142812602|SUPERIORITY_OR_OTHER||Increase in % on target (PR Logic)|3.2|||<|0.0001|||||||McNemar|||PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.||||<0.0001
71647553|NCT05061992|142812610|SUPERIORITY|||||||0.6|||||||ANCOVA|||Change in SF-8||||0.6
71647554|NCT05061992|142812610|SUPERIORITY|||||||0.2|||||||ANCOVA|||End of trial SF-8||||0.2
71647555|NCT05061992|142812611|SUPERIORITY|||||||0.001|||||||ANCOVA|||Change in ANT||||0.001
71762733|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-2.45||||0.0332|TWO_SIDED|90.0|-4.34|-0.56|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.56|-4.34|0.0332
71647556|NCT05061992|142812611|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||End of trial ANT||||0.09
71647557|NCT05061992|142812612|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71647558|NCT05061992|142812613|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
71647559|NCT05061992|142812614|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
71647560|NCT05061992|142812615|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71647561|NCT01157234|142812625|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|28.73|||||TWO_SIDED|95.0|1.93|55.53||||||||55.53|1.93|
71647562|NCT01157234|142812626|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.27|||||TWO_SIDED|95.0|-12.58|29.12||||||||29.12|-12.58|
71647563|NCT01157234|142812627|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.23|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-6.74|9.2||||||||9.20|-6.74|
71647564|NCT01157234|142812631|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.94|||||TWO_SIDED|95.0|0.48|23.4||||||||23.40|0.48|
71647565|NCT01157234|142812632|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|69.54|STANDARD_ERROR_OF_MEAN|19.83|||TWO_SIDED|99.7|12.71|126.37||||||||126.37|12.71|
71647566|NCT01157234|142812633|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|68.19|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|99.17|13.02|123.36||||||||123.36|13.02|
71647567|NCT01157234|142812634|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.39|STANDARD_ERROR_OF_MEAN|17.32|||TWO_SIDED|99.17|-48.25|51.03||||||||51.03|-48.25|
71647568|NCT01157234|142812635|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|17.96|||TWO_SIDED|99.17|-48.74|54.22||||||||54.22|-48.74|
71647569|NCT01513239|142812638|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-5.1||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-5.1|-16.4|<0.0001
71647570|NCT01513239|142812638|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0003|TWO_SIDED|95.0|-15.5|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-4.3|-15.5|0.0003
71647571|NCT01513239|142812638|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.8||||0.3718|TWO_SIDED|95.0|-5.9|4.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||4.2|-5.9|0.3718
71647572|NCT01513239|142812639|SUPERIORITY_OR_OTHER||Adjusted Difference|5.2||||0.0722|TWO_SIDED|95.0|-1.8|12.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||12.2|-1.8|0.0722
71647573|NCT01513239|142812639|SUPERIORITY_OR_OTHER||Adjusted Difference|14.6|||<|0.0001|TWO_SIDED|95.0|7.7|21.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||21.4|7.7|<0.0001
71647574|NCT01513239|142812639|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.4||||0.9969|TWO_SIDED|95.0|-16.1|-2.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||-2.7|-16.1|0.9969
71647575|NCT01513239|142812640|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.9||||0.0006|TWO_SIDED|95.0|-19.0|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||-4.7|-19.0|0.0006
71647576|NCT01513239|142812640|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-20.4|-6.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||-6.9|-20.4|<0.0001
71647577|NCT01513239|142812640|SUPERIORITY_OR_OTHER||Adjusted Difference|1.6||||0.6962|TWO_SIDED|95.0|-4.6|8.0||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC|||8.0|-4.6|0.6962
71647578|NCT01513239|142812641|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.9||||0.408|TWO_SIDED|95.0|-9.8|4.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo +SOC|||4.0|-9.8|0.408
71647579|NCT01513239|142812641|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.3||||0.517|TWO_SIDED|95.0|-9.2|4.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||4.6|-9.2|0.517
71647580|NCT01513239|142812642|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2||||0.931|TWO_SIDED|95.0|-3.8|3.5|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||3.5|-3.8|0.931
71647581|NCT01513239|142812642|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0||||0.997|TWO_SIDED|95.0|-3.7|3.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||3.6|-3.7|0.997
71647582|NCT01513239|142812643|SUPERIORITY_OR_OTHER||Difference in Percentages|0.5||||0.328|TWO_SIDED|95.0|-0.8|2.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||2.0|-0.8|0.328
71647583|NCT01513239|142812643|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.3||||0.308|TWO_SIDED|95.0|-1.5|0.7|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||0.7|-1.5|0.308
71647584|NCT01513239|142812644|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
71647585|NCT01513239|142812644|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC|||1.0|-1.0|>0.999
71647586|NCT01513239|142812645|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.4|||||TWO_SIDED|95.0|-4.2|3.3|||||MK-3415A + SOC minus Placebo + SOC|||3.3|-4.2|
71647587|NCT01513239|142812645|SUPERIORITY_OR_OTHER||Difference in Percentages|1.2|||||TWO_SIDED|95.0|-2.7|5.2|||||MK-6072 + SOC minus Placebo + SOC|||5.2|-2.7|
71762734|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.7224|TWO_SIDED|90.0|-2.3|1.48|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.48|-2.30|0.7224
71647588|NCT00059332|142812668|SUPERIORITY_OR_OTHER|||||||0.28|ONE_SIDED||||||Cochran-Mantel-Haenszel|||For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.||||0.28
71647589|NCT00059332|142812669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||||1.20|0.81|0.87
71647590|NCT00059332|142812670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.87|TWO_SIDED|95.0|0.81|1.19|||Chi-squared|||||1.19|0.81|0.87
71647591|NCT00059332|142812671|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2760
71647592|NCT00059332|142812672|SUPERIORITY_OR_OTHER|||||||0.3912|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3912
71647593|NCT00059332|142812673|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3230
71647594|NCT00059332|142812674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.95|TWO_SIDED|95.0|0.87|1.27|||Chi-squared|||||1.27|0.87|0.95
71647595|NCT00059332|142812675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.12|TWO_SIDED|95.0|0.34|1.14|||Chi-squared|||||1.14|0.34|0.12
71647596|NCT00059332|142812676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.76|1.29|||Chi-squared|||||1.29|0.76|0.95
71647597|NCT04281472|142812757|SUPERIORITY||Hazard Ratio (HR)|0.394|||||TWO_SIDED|95.0|0.253|0.614||||||||0.614|0.253|
71647598|NCT01717313|142812788|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status||||-0.19|-0.59|<0.001
71647599|NCT01717313|142812789|SUPERIORITY_OR_OTHER||Differences in percentages vs. placebo|-8.2|||||TWO_SIDED|95.0|-18.8|2.6||||||||2.6|-18.8|
71647600|NCT01717313|142812790|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.1|4.5||||||||4.5|-3.1|
71647601|NCT01717313|142812791|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|-5.8|||||TWO_SIDED|95.0|-16.4|4.9||||||||4.9|-16.4|
71647602|NCT01717313|142812792|SUPERIORITY_OR_OTHER||Difference in percentages vs. placebo|0.6|||||TWO_SIDED|95.0|-3.5|4.8||||||||4.8|-3.5|
71647603|NCT01717313|142812793|SUPERIORITY_OR_OTHER||Between-group rate difference|20.3|||<|0.001|TWO_SIDED|95.0|10.5|29.8|||Miettinen & Nurminen method|||||29.8|10.5|<0.001
71647604|NCT01717313|142812794|SUPERIORITY_OR_OTHER||Between-group rate difference|11.4||||0.001|TWO_SIDED|95.0|4.8|18.6|||Miettinen & Nurminen method|||||18.6|4.8|0.001
71647605|NCT01717313|142812795|SUPERIORITY_OR_OTHER||Difference in the least squares means|-10.3||||0.036|TWO_SIDED|95.0|-19.9|-0.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.7|-19.9|0.036
71647606|NCT01717313|142812796|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.6||||0.177|TWO_SIDED|95.0|-28.6|5.3|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||5.3|-28.6|0.177
71647607|NCT01717313|142812801|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.53|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-0.32|-0.75|<0.001
71647608|NCT01717313|142812802|SUPERIORITY_OR_OTHER||Difference in the least squares means|-13.2||||0.014|TWO_SIDED|95.0|-23.7|-2.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-2.7|-23.7|0.014
71824239|NCT02857283|143152102|SUPERIORITY|||||||0.79|||||||Wilcoxon signed rank test|||||||0.79
71824240|NCT02857283|143152103|SUPERIORITY|||||||0.094|||||||ANOVA|||||||0.094
71647609|NCT01717313|142812803|SUPERIORITY_OR_OTHER||Difference in the least squares means|-20.5||||0.031|TWO_SIDED|95.0|-39.0|-1.9|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status||||-1.9|-39.0|0.031
71647610|NCT00835588|142812806|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|88.8||||||90.0|82.7|95.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||95.4|82.7|
71647611|NCT00835588|142812807|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|93.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101|93.4|
71647612|NCT00835588|142812808|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|91.6|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|91.6|
71647613|NCT00354159|142812831|SUPERIORITY_OR_OTHER||6-month survival rate|90.5|||<|0.001|ONE_SIDED|97.5|87.7|||The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard \[e.g. log survival estimate\] for the variance.|Survival estimate at 6-months|The survival estimate at 6-months post-implant was compared to 80%.||"Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%."|||87.7|<0.001
71647614|NCT00354159|142812833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.978|TWO_SIDED|95.0|0.61|1.61||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.~Null Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different."||1.61|0.61|0.978
71647615|NCT00354159|142812834|SUPERIORITY_OR_OTHER|||||||0.574||95.0|||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)~where mu is the percentage of hospitalized days for heart failure."||||0.574
71647616|NCT00354159|142812835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.527|TWO_SIDED|95.0|0.62|1.28||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill Model||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different."||1.28|0.62|0.527
71647617|NCT00354159|142812836|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.505|TWO_SIDED|95.0|0.57|1.32|||Regression, Cox|The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.|Hazard Ratio is for the Treatment Arm relative to the Control Arm|"Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.~Alternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm."||1.32|0.57|0.505
71647618|NCT00354159|142812837|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.088|TWO_SIDED|95.0|0.56|1.04|||Andersen-Gill Model|The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The all cause event rate between the treatment arm and control arm is different."||1.04|0.56|0.088
71647619|NCT00354159|142812838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.758|TWO_SIDED|95.0|0.73|1.54||P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.|Proportional odds model||Odds ratio represents the odds of improved score in the treatment group relative to the control group.|"Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.~Alternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm."||1.54|0.73|0.758
71660971|NCT03118570|142835407|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.515||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 6||||0.515
71762735|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.6507|TWO_SIDED|90.0|-1.37|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.41|-1.37|0.6507
71824241|NCT01207908|143152104|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.53|TWO_SIDED|95.0|-37.1|20.1|||t-test, 2 sided|||||20.1|-37.1|0.53
71660972|NCT03118570|142835407|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.786||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.786
71660973|NCT03118570|142835407|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.212||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.212
71660974|NCT03118570|142835407|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.655||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Month 12||||0.655
71824242|NCT01207908|143152105|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.78|-1.55|||t-test, 2 sided|||||-1.55|-3.78|<0.0001
71647620|NCT00354159|142812841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.599|TWO_SIDED|95.0|0.29|2.06|||Regression, Cox|The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model|Hazard ratio estimates the hazard of death in the treatment group relative to the control group.|"Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.~Alternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups."||2.06|0.29|0.599
71647621|NCT00354159|142812842|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Negative-Binomial Regression|||The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.||||0.145
71647622|NCT00354159|142812843|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||t-test, 2 sided|||"Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.~Alternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms."||||0.033
71647623|NCT00354159|142812844|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||"Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.~Alternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period."||||0.002
71647624|NCT00354159|142812845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.292|TWO_SIDED|95.0|0.82|1.96|||Proportional odds regression model||Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.|"Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.~Alternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms."||1.96|0.82|0.292
71647625|NCT00354159|142812846|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.~Alternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms."||||0.996
71647626|NCT00354159|142812847|SUPERIORITY_OR_OTHER|||||||0.154||95.0|||||Mixed Models Analysis|||"Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.~Alternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm."||||0.154
71647627|NCT00354159|142812850|SUPERIORITY_OR_OTHER|||||||0.583||95.0|||||Mixed Models Analysis|Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.||"Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.~Alternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm."||||0.583
71647628|NCT00354159|142812851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.48||||0.368|TWO_SIDED|95.0|0.63|3.5||The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.|Andersen-Gill Model|Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.||"Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.~Alternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm."||3.5|0.63|0.368
71647629|NCT04387617|142812898|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.6||0.5|TWO_SIDED|95.0|-0.8|1.6|||t-test, 2 sided|||||1.6|-0.8|0.5
71647630|NCT02413008|142812902|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.1|||||||Wilcoxon (Mann-Whitney)|||"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.~The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit."||||0.10
71647631|NCT02413008|142812902|OTHER|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.413|||||||Wilcoxon (Mann-Whitney)|||The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.||||0.413
71647632|NCT02413008|142812902|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71647633|NCT02413008|142812903|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 1||||<0.05
71702443|NCT01482221|142921886|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.264||0.992|TWO_SIDED|95.0|-2.477|2.501||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||2.501|-2.477|0.992
71702444|NCT01482221|142921886|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.301||0.392|TWO_SIDED|95.0|-1.448|3.678||Analysis for change in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.678|-1.448|0.392
71702445|NCT01482221|142921886|SUPERIORITY_OR_OTHER||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|1.329||0.333|TWO_SIDED|95.0|-1.327|3.908||Analysis for changed in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.908|-1.327|0.333
71647634|NCT02413008|142812903|OTHER||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 3||||<0.05
71647635|NCT02413008|142812903|OTHER||||||>|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 8||||>0.05
71647636|NCT02413008|142812904|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 1||||>0.05
71647637|NCT02413008|142812904|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 3||||>0.05
71647638|NCT02413008|142812904|OTHER||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 8||||>0.05
71647639|NCT02413008|142812904|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 12||||0.135
71647640|NCT02413008|142812905|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estriol||||0.043
71647641|NCT02413008|142812905|OTHER|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estriol||||0.649
71647642|NCT02413008|142812905|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 8 in plasma levels of estriol||||0.588
71647643|NCT02413008|142812905|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12 in plasma levels of estriol||||0.67
71647644|NCT02413008|142812906|OTHER|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estradiol.||||0.342
71647645|NCT02413008|142812906|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estradiol.||||0.523
71647646|NCT02413008|142812906|OTHER|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 8||||0.523
71647647|NCT02413008|142812906|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 12||||0.163
71824243|NCT01207908|143152106|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.53|TWO_SIDED|95.0|-1.26|2.38|||t-test, 2 sided|||||2.38|-1.26|0.53
71647648|NCT02413008|142812907|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 1||||0.418
71647649|NCT02413008|142812907|OTHER|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 3||||0.642
71824244|NCT05074498|143152147|OTHER||Least square mean difference|-0.35||||0.0838|TWO_SIDED|95.0|-0.741|0.047|||Mixed Models Analysis|||||0.047|-0.741|0.0838
71824245|NCT02967016|143152189|OTHER|||||||0.002|||||||Kruskal-Wallis|||Cumulative Steps 6 h||||0.002
71824246|NCT02967016|143152189|OTHER|||||||0.0002|||||||Kruskal-Wallis|||Cumulative steps 12 h||||.0002
71647650|NCT02413008|142812907|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 8||||0.175
71647651|NCT02413008|142812907|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 12||||0.084
71647652|NCT02413008|142812908|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 3||||<0.01
71647653|NCT02413008|142812908|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 12||||0.057
71647654|NCT02413008|142812909|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 3||||0.14
71647655|NCT02413008|142812909|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 12||||0.25
71647656|NCT02413008|142812910|OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||0.28
71647657|NCT02413008|142812910|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||0.34
71647658|NCT02413008|142812911|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 3||||0.14
71647659|NCT02413008|142812911|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 12||||<0.01
71647660|NCT02413008|142812912|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 3||||0.03
71647661|NCT02413008|142812912|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 12||||0.04
71647662|NCT02413008|142812913|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||<0.001
71647663|NCT02413008|142812913|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa betweeen baseline and week 12||||<0.01
71647664|NCT02413008|142812914|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3||||0.13
71647665|NCT02413008|142812914|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 12||||<0.01
71647666|NCT02413008|142812915|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3||||<0.001
71647667|NCT02413008|142812915|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12||||<0.001
71647668|NCT02413008|142812916|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 3 and baseline||||<0.001
71647669|NCT02413008|142812916|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 12 and baseline||||<0.001
71647670|NCT02413008|142812917|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 3||||<0.0001
71647671|NCT02413008|142812917|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 12||||0.006
71647672|NCT01139762|142812935|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.41||||0.001|TWO_SIDED|95.0|-2.27|-0.55|||Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.55|-2.27|0.001
71824247|NCT02967016|143152189|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 24 h||||.0006
71824248|NCT02967016|143152189|OTHER|||||||0.0006|||||||Kruskal-Wallis|||Cumulative steps 36 h||||0.0006
71824249|NCT02967016|143152189|OTHER|||||||0.03|||||||Kruskal-Wallis|||Cumulative steps 48 h||||0.03
71824250|NCT02967016|143152190|OTHER|||||||0.06|||||||Kruskal-Wallis|||Pain at rest 6 h||||0.06
71824251|NCT02967016|143152190|OTHER|||||||0.3|||||||Kruskal-Wallis|||Pain at rest 12 h||||.30
71824252|NCT02967016|143152190|OTHER|||||||0.002|||||||Kruskal-Wallis|||Pain at rest 24 h||||.002
71886416|NCT00848354|143293311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89||||0.0059|TWO_SIDED|95.0|1.31|6.34||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||6.34|1.31|0.0059
71647673|NCT01139762|142812937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14||P-value is for IPSS storage (irritative) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.87|0.007
71647674|NCT01139762|142812937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.04|TWO_SIDED|95.0|-0.8|-0.02||P-value is for IPSS storage (irritative) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.02|-0.80|0.040
71647675|NCT01139762|142812937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.107|TWO_SIDED|95.0|-0.75|0.07||P-value is for IPSS storage (irritative) subscore - 26 weeks|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.07|-0.75|0.107
71647676|NCT01139762|142812937|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.69|-0.68||P-value is for IPSS voiding (obstructive) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.68|-1.69|<0.001
71647677|NCT01139762|142812937|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.62|-0.46||P-value is for IPSS voiding (obstructive) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.46|-1.62|<0.001
71647678|NCT01139762|142812937|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73||||0.015|TWO_SIDED|95.0|-1.32|-0.14||P-value is IPSS voiding (obstructive) subscore - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-1.32|0.015
71647679|NCT01139762|142812938|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.14||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||-0.14|-0.50|<0.001
71647680|NCT01139762|142812938|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.051|TWO_SIDED|95.0|-0.38|0.0||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.00|-0.38|0.051
71647681|NCT01139762|142812938|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.107|TWO_SIDED|95.0|-0.38|0.04||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.04|-0.38|0.107
71702446|NCT01482221|142921887|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.728|TWO_SIDED|95.0|-0.49|0.34||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.34|-0.49|0.728
71762736|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-1.72||||0.1366|TWO_SIDED|90.0|-3.62|0.18|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.18|-3.62|0.1366
71824253|NCT02967016|143152190|OTHER|||||||0.003|||||||Kruskal-Wallis|||Pain at rest 36 h||||0.003
71824254|NCT02967016|143152190|OTHER|||||||0.02|||||||Kruskal-Wallis|||Pain at rest at 48 h||||.02
71824255|NCT02967016|143152191|OTHER|||||||0.43|||||||Kruskal-Wallis|||Satisfaction with pain control 6 h||||.43
71824256|NCT02967016|143152191|OTHER|||||||0.24|||||||Kruskal-Wallis|||Satisfaction with pain control 12 h||||.24
71824257|NCT02967016|143152191|OTHER|||||||0.012|||||||Kruskal-Wallis|||Satisfaction with pain control 24 h||||.012
71886417|NCT00848354|143293311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001|TWO_SIDED|95.0|1.99|9.29||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||9.29|1.99|<0.0001
71647682|NCT01139762|142812939|SUPERIORITY_OR_OTHER||LS Mean Difference|4.85|||<|0.001|TWO_SIDED|95.0|3.49|6.21||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.21|3.49|<0.001
71647683|NCT01139762|142812939|SUPERIORITY_OR_OTHER||LS Mean Difference|4.08|||<|0.001|TWO_SIDED|95.0|2.55|5.6||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||5.60|2.55|<0.001
71647684|NCT01139762|142812939|SUPERIORITY_OR_OTHER||LS Mean Difference|4.73|||<|0.001|TWO_SIDED|95.0|3.15|6.31||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||6.31|3.15|<0.001
71647685|NCT01139762|142812940|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.4||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.40|0.61|<0.001
71647686|NCT01139762|142812940|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|||<|0.001|TWO_SIDED|95.0|0.61|1.51||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.51|0.61|<0.001
71647687|NCT01139762|142812940|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.74|1.69||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.69|0.74|<0.001
71647688|NCT01139762|142812941|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.18|2.47||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.47|1.18|<0.001
71647689|NCT01139762|142812941|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.88|2.31||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.31|0.88|<0.001
71647690|NCT01139762|142812941|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.23|2.73||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.73|1.23|<0.001
71647691|NCT01139762|142812942|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|0.92|2.13||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||2.13|0.92|<0.001
71647692|NCT01139762|142812942|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.006|TWO_SIDED|95.0|0.27|1.54||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.54|0.27|0.006
71647693|NCT01139762|142812942|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.41|1.74||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.74|0.41|0.002
71824258|NCT02967016|143152191|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Satisfaction with pain control 36 h||||<0.0001
71824259|NCT02967016|143152191|OTHER|||||||0.0005|||||||Kruskal-Wallis|||Satisfaction with pain control 48 h||||.0005
71647694|NCT01139762|142812943|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.25||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.25|0.61|<0.001
71647695|NCT01139762|142812943|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.44|1.14||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.14|0.44|<0.001
71647696|NCT01139762|142812943|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.39|1.13||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.13|0.39|<0.001
71647697|NCT01139762|142812944|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.034
71647698|NCT01139762|142812945|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Van Elteren test|Van Elteren test was stratified by region.||||||0.031
71647699|NCT01139762|142812946|SUPERIORITY_OR_OTHER|||||||0.328||95.0||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.||||||0.328
71647700|NCT01139762|142812947|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon Rank-Sum test|||||||0.157
71647701|NCT01139762|142812948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|||<|0.001|TWO_SIDED|95.0|0.49|0.98||P-value is for Question 3 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.98|0.49|<0.001
71647702|NCT01139762|142812948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.43|0.93||P-value is for Question 3 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.93|0.43|<0.001
71647703|NCT01139762|142812948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|||<|0.001|TWO_SIDED|95.0|0.48|1.02||P-value is for Question 3 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||1.02|0.48|<0.001
71647704|NCT01139762|142812948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.46|0.95||P-value is for Question 4 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.95|0.46|<0.001
71647705|NCT01139762|142812948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|||<|0.001|TWO_SIDED|95.0|0.36|0.85||P-value is for Question 4 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.85|0.36|<0.001
71647706|NCT01139762|142812948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.35|0.89||P-value is for Question 4 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.||0.89|0.35|<0.001
71647707|NCT02614196|142812949|SUPERIORITY||LSMean Difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.55|-1.48|||Mixed Models Analysis|||||-1.48|-2.55|<.001
71647708|NCT02614196|142812949|SUPERIORITY||LSMean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.44|-1.36|||Mixed Models Analysis|||||-1.36|-2.44|<.001
71647709|NCT02614196|142812950|SUPERIORITY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|2.03|3.32||||||Reduction from Baseline ≥50%||3.32|2.03|
71647710|NCT02614196|142812950|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|1.81|2.96||||||Reduction from Baseline ≥50%||2.96|1.81|
71647711|NCT02614196|142812950|SUPERIORITY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.78|3.06||||||Reduction from Baseline ≥75%||3.06|1.78|
71647712|NCT02614196|142812950|SUPERIORITY||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.84|3.17||||||Reduction from Baseline ≥75%||3.17|1.84|
71647713|NCT02614196|142812950|SUPERIORITY||Odds Ratio (OR)|2.16|||||TWO_SIDED|95.0|1.5|3.12||||||Reduction from Baseline ≥100%||3.12|1.50|
71647714|NCT02614196|142812950|SUPERIORITY||Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.87|3.81||||||Reduction from Baseline ≥100%||3.81|1.87|
71647715|NCT02614196|142812951|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|6.33|11.31|||Mixed Models Analysis|||||11.31|6.33|<.001
71824260|NCT01996644|143152193|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||ANOVA|||||||.043
71647716|NCT02614196|142812951|SUPERIORITY||LSMean Difference|7.39|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|4.88|9.9|||Mixed Models Analysis|||||9.90|4.88|<.001
71647717|NCT02614196|142812952|SUPERIORITY||LSMean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.29|-1.36|||Mixed Models Analysis|||||-1.36|-2.29|<.001
71647718|NCT02614196|142812952|SUPERIORITY||LSMean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.001
71647719|NCT02614196|142812953|SUPERIORITY||LSMean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.002|TWO_SIDED|95.0|-0.47|-0.11|||Mixed Models Analysis|||||-0.11|-0.47|.002
71647720|NCT02614196|142812953|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.012|TWO_SIDED|95.0|-0.41|-0.05|||Mixed Models Analysis|||||-0.05|-0.41|.012
71647721|NCT02614196|142812954|SUPERIORITY||LSMean Difference|-15.19|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-20.27|-10.11|||Mixed Models Analysis|||||-10.11|-20.27|<.001
71647722|NCT02614196|142812954|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.67|-8.44|||Mixed Models Analysis|||||-8.44|-18.67|<.001
71647723|NCT02614196|142812955|SUPERIORITY||LSMean Difference|-9.15|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-12.61|-5.69|||Mixed Models Analysis|||||-5.69|-12.61|<.001
71647724|NCT02614196|142812955|SUPERIORITY||LSMean Difference|-8.22|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-11.71|-4.72|||Mixed Models Analysis|||||-4.72|-11.71|<.001
71647725|NCT02614196|142812956|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive.||||<.001
71702447|NCT01482221|142921887|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.562|TWO_SIDED|95.0|-0.54|0.29||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.29|-0.54|0.562
71647726|NCT02614196|142812956|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||TE ADA Positive||||<.001
71647727|NCT02627001|142812969|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Ranks|||||||<0.001
71647728|NCT05194202|142812974|OTHER|||||||0.622|||||||one-sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test.||Our null hypothesis for the acceptability was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.622
71702448|NCT01482221|142921887|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.283|TWO_SIDED|95.0|-0.64|0.19||Analysis for change in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.19|-0.64|0.283
71762737|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-2.81||||0.0153|TWO_SIDED|90.0|-4.71|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-4.71|0.0153
71647729|NCT05194202|142812975|OTHER|||||||0.038|||||||one sample test of proportions|Hypothesis was evaluated using a one-tailed, one-proportion z-test||Our null hypothesis for the acceptabnility of the ED-Heart was P0 great than or equal to 85% vs. the alternative P0 less than 85%. Acceptability responses were dichotomized to include neutral with strongly disagree/disagree.||||.038
71647730|NCT02005562|142812986|SUPERIORITY_OR_OTHER|||||||0.479|||||||Chi-squared|||||||0.479
71647731|NCT02005562|142812987|SUPERIORITY_OR_OTHER|||||||0.6736|||||||ANOVA|||||||0.6736
71647732|NCT02005562|142812988|SUPERIORITY_OR_OTHER|||||||0.2172|||||||ANOVA|||||||0.2172
71647733|NCT02005562|142812989|SUPERIORITY_OR_OTHER|||||||0.477|||||||ANOVA|||||||0.4770
71647734|NCT02005562|142812991|SUPERIORITY_OR_OTHER|||||||0.0764|||||||Log Rank|||||||0.0764
71647735|NCT02005562|142812992|SUPERIORITY_OR_OTHER|||||||0.418|||||||Fisher Exact|||Week 12||||0.418
71647736|NCT02005562|142812992|SUPERIORITY_OR_OTHER|||||||0.841|||||||Fisher Exact|||Week 52||||0.841
71647737|NCT02005562|142812993|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Week 12||||0.245
71647738|NCT02005562|142812993|SUPERIORITY_OR_OTHER|||||||0.637|||||||Fisher Exact|||Week 52||||0.637
71647739|NCT02005562|142812994|SUPERIORITY_OR_OTHER|||||||0.512||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 12.|Fisher Exact|||||||0.512
71647740|NCT02005562|142812994|SUPERIORITY_OR_OTHER|||||||0.718||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 52.|Fisher Exact|||||||0.718
71647741|NCT02005562|142812996|SUPERIORITY_OR_OTHER|||||||0.86|||||||Log Rank|||||||0.860
71647742|NCT03930849|142813008|OTHER||F-value for Type 3 Fixed, df=4|2.01||||0.1|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time term in a mixed methods analysis.||||||0.10
71647743|NCT03930849|142813009|SUPERIORITY||F statistic GroupxTime, df=4|0.025||||0.9|TWO_SIDED||||||Mixed Models Analysis|P-value is for F-value reported below of group x time analysis in a mixed methods analysis.||||||0.90
71647744|NCT03930849|142813010|SUPERIORITY||F Value Group x Time, DF=4|2.12||||0.08|TWO_SIDED|||||P-value of F statistic reported below for mixed methods analysis group\*time interaction term.|Mixed Models Analysis|||||||0.08
71647745|NCT01251393|142813014|EQUIVALENCE|"The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.~We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."|||||<|0.05||||||We used an ANOVA for repeated measures, followed by Bonferroni's post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.|ANOVA|||We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.||||<0.05
71647746|NCT00660387|142813015|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
71647747|NCT00660387|142813016|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
71647748|NCT00660387|142813017|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the CGI-Severity (CGI-S, see Baseline Characteristics module) as a covariate.|ANCOVA|||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
71647749|NCT00660387|142813018|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
71647750|NCT00660387|142813019|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
71647751|NCT00660387|142813020|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
71647752|NCT00660387|142813021|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
71647753|NCT00660387|142813022|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
71647754|NCT00660387|142813023|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
71647755|NCT00660387|142813024|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
71647756|NCT00660387|142813025|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
71647757|NCT00660387|142813026|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
71647758|NCT00660387|142813027|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
71647759|NCT00660387|142813028|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
71647760|NCT00660387|142813029|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
71702449|NCT01482221|142921887|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.54|TWO_SIDED|95.0|-0.29|0.55||Analysis for changed in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.||0.55|-0.29|0.540
71647761|NCT00660387|142813030|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
71647762|NCT00660387|142813031|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
71647763|NCT00660387|142813032|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
71647764|NCT00660387|142813033|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
71647765|NCT00660387|142813034|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
71647766|NCT00660387|142813035|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
71647767|NCT00660387|142813036|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
71647768|NCT04729101|142813039|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|38.98|||||TWO_SIDED|95.0|31.94|46.02||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||46.02|31.94|
71647769|NCT04729101|142813039|OTHER|Additional statistics were descriptive in nature|Least-squares mean difference|44.62|||||TWO_SIDED|95.0|37.55|51.69||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||51.69|37.55|
71647770|NCT04729101|142813040|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|1.72|||||TWO_SIDED|95.0|1.4|2.04||||||Vonoprazan versus lansoprazole on Day 1 of each treatment period.||2.04|1.40|
71702450|NCT01482221|142921888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|STANDARD_ERROR_OF_MEAN|0.302||0.067|TWO_SIDED|95.0|0.962|3.141|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||3.141|0.962|0.067
71647771|NCT04729101|142813040|OTHER|Additional statistics were descriptive in nature.|Least-squares mean difference|2.09|||||TWO_SIDED|95.0|1.74|2.44||||||Vonoprazan versus lansoprazole on Day 7 of each treatment period.||2.44|1.74|
71647772|NCT03086135|142813048|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
71647773|NCT03086135|142813049|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in noise at 3 months with the Osia system vs Unaided at visit 1||||<0.0001
71647774|NCT03086135|142813050|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647775|NCT03086135|142813050|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647776|NCT03086135|142813050|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647777|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647778|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647779|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647780|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647781|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647782|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647783|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647784|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647785|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647786|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647787|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647788|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647789|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647790|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647791|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647792|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647793|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647794|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647795|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647796|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647797|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647798|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647799|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647800|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647801|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647802|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647803|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647804|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647805|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647806|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647807|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647808|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647809|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647810|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647811|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647812|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647813|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647814|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647815|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647816|NCT03086135|142813051|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647817|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647818|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647819|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647820|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647821|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647822|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71886418|NCT00848354|143293311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|2.88|12.24||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||12.24|2.88|<0.0001
71647823|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647824|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647825|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647826|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647827|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647828|NCT03086135|142813052|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647829|NCT03086135|142813053|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.||||<0.0001
71647830|NCT03086135|142813053|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647831|NCT03086135|142813053|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647832|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647833|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647834|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647835|NCT03086135|142813054|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.||||0.51
71647836|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647837|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647838|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647839|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647840|NCT03086135|142813054|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.||||0.32
71647841|NCT03086135|142813054|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647842|NCT03086135|142813055|SUPERIORITY|||||||0.026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.||||0.026
71647843|NCT03086135|142813055|SUPERIORITY|||||||0.5|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.||||0.50
71647844|NCT03086135|142813055|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.0008
71824261|NCT03613129|143152244|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.011|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.011
71647845|NCT03086135|142813055|SUPERIORITY|||||||0.082|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.082
71647846|NCT03086135|142813055|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.13
71647847|NCT03086135|142813055|SUPERIORITY|||||||0.9|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.9
71647848|NCT03086135|142813055|SUPERIORITY|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.43
71647849|NCT03086135|142813055|SUPERIORITY|||||||0.31|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.31
71647850|NCT03086135|142813055|SUPERIORITY|||||||0.72|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.||||0.72
71647851|NCT03086135|142813055|SUPERIORITY|||||||0.13|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.13
71647852|NCT03086135|142813055|SUPERIORITY|||||||0.23|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.23
71647853|NCT03086135|142813055|SUPERIORITY|||||||0.0026|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0026
71647854|NCT03086135|142813055|SUPERIORITY|||||||0.0024|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.0024
71647855|NCT03086135|142813055|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
71647856|NCT03086135|142813055|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.16
71647857|NCT03086135|142813055|SUPERIORITY|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.85
71647858|NCT03086135|142813055|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.||||1.0
71647859|NCT03086135|142813055|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.||||0.56
71647860|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647861|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647862|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647863|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647864|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647865|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647866|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647867|NCT03086135|142813056|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.||||<0.0001
71647868|NCT03086135|142813057|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647869|NCT03086135|142813057|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647870|NCT03086135|142813057|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647871|NCT03086135|142813057|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647872|NCT03086135|142813058|SUPERIORITY|||||||0.025|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.025
71647873|NCT03086135|142813058|SUPERIORITY|||||||0.096|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.096
71647874|NCT03086135|142813058|SUPERIORITY|||||||0.015|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.015
71647875|NCT03086135|142813058|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.67
71647876|NCT03086135|142813058|SUPERIORITY|||||||0.73|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.73
71647877|NCT03086135|142813058|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.019
71647878|NCT03086135|142813058|SUPERIORITY|||||||0.0046|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||0.0046
71647879|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647880|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647881|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647882|NCT03086135|142813058|SUPERIORITY|||||||0.019|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.019
71647883|NCT03086135|142813058|SUPERIORITY|||||||0.04|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.040
71702451|NCT01482221|142921888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|STANDARD_ERROR_OF_MEAN|0.297||0.23|TWO_SIDED|95.0|0.798|2.558|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.558|0.798|0.230
71647884|NCT03086135|142813058|SUPERIORITY|||||||0.037|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.037
71647885|NCT03086135|142813058|SUPERIORITY|||||||0.67|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.67
71647886|NCT03086135|142813058|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.34
71647887|NCT03086135|142813058|SUPERIORITY|||||||0.0048|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0048
71647888|NCT03086135|142813058|SUPERIORITY|||||||0.0008|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||0.0008
71647889|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647890|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647891|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647892|NCT03086135|142813058|SUPERIORITY|||||||0.1|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.10
71647893|NCT03086135|142813058|SUPERIORITY|||||||0.0007|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0007
71647894|NCT03086135|142813058|SUPERIORITY|||||||0.0003|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0003
71647895|NCT03086135|142813058|SUPERIORITY|||||||0.11|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.11
71886419|NCT00848354|143293311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.18|||<|0.0001|TWO_SIDED|95.0|3.61|23.32||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||23.32|3.61|<0.0001
71647896|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647897|NCT03086135|142813058|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||0.0001
71647898|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647899|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647900|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647901|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647902|NCT03086135|142813058|SUPERIORITY|||||||0.8|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.80
71647903|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647904|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647905|NCT03086135|142813058|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||0.0010
71647906|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647907|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647908|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647909|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647910|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647911|NCT03086135|142813058|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.||||<0.0001
71647912|NCT03086135|142813059|SUPERIORITY|||||||0.51|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.51
71647913|NCT03086135|142813059|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.021
71647914|NCT03086135|142813059|SUPERIORITY|||||||0.29|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.||||0.29
71647915|NCT03086135|142813059|SUPERIORITY|||||||0.18|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.18
71647916|NCT03086135|142813059|SUPERIORITY|||||||0.017|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.017
71647917|NCT03086135|142813059|SUPERIORITY|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.||||0.16
71647918|NCT03086135|142813059|SUPERIORITY|||||||0.0051|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.0051
71647919|NCT03086135|142813059|SUPERIORITY|||||||0.021|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.021
71647920|NCT03086135|142813059|SUPERIORITY|||||||0.56|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.||||0.56
71647921|NCT03086135|142813059|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
71647922|NCT03086135|142813059|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||<0.0001
71647923|NCT03086135|142813059|SUPERIORITY|||||||0.041|TWO_SIDED|95.0|||||Wilcoxon Signed Rank test|||Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.||||0.041
71647924|NCT03086135|142813060|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.||||<0.0001
71647925|NCT03086135|142813060|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.||||<0.0001
71647926|NCT03086135|142813060|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.||||<0.0001
71647927|NCT03086135|142813060|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.||||<0.0001
71647928|NCT01023061|142813076|SUPERIORITY||Median Difference (Final Values)|0.74|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.01
71647929|NCT00762411|142813079|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Mixed Models Analysis|||||||0.560
71647930|NCT00762411|142813080|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Mixed Models Analysis|||||||0.959
71647931|NCT00762411|142813081|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Models Analysis|||||||0.567
71647932|NCT00762411|142813082|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Mixed Models Analysis|||||||0.199
71647933|NCT00762411|142813083|SUPERIORITY_OR_OTHER|||||||0.294||95.0|||||Mixed Models Analysis|||||||0.294
71647934|NCT00762411|142813084|SUPERIORITY_OR_OTHER|||||||0.477||95.0|||||Mixed Models Analysis|||||||0.477
71647935|NCT00762411|142813085|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||ANCOVA|||||||0.673
71647936|NCT00762411|142813086|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Mixed Models Analysis|||||||0.622
71647937|NCT00762411|142813087|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Mixed Models Analysis|||||||0.178
71647938|NCT00762411|142813088|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||Mixed Models Analysis|||||||0.632
71647939|NCT00762411|142813089|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|||||||0.009
71647940|NCT00762411|142813090|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||ANCOVA|||||||0.426
71647941|NCT00762411|142813091|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||This is the p-value for the Right Hippocampal Volume.|ANCOVA|||||||0.101
71647942|NCT00762411|142813091|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||This is the p-value for the Left Hippocampal Volume.|ANCOVA|||||||0.772
71647943|NCT00762411|142813092|SUPERIORITY_OR_OTHER|||||||0.326||95.0|||||ANCOVA|||||||0.326
71647944|NCT00762411|142813093|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||0.117
71647945|NCT00762411|142813102|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|||||||0.929
71647946|NCT00762411|142813103|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||||||0.437
71647947|NCT00762411|142813104|SUPERIORITY_OR_OTHER|||||||0.318||95.0|||||ANCOVA|||||||0.318
71647948|NCT00762411|142813105|SUPERIORITY_OR_OTHER|||||||0.417||95.0|||||ANCOVA|||||||0.417
71647949|NCT00762411|142813106|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Mixed Models Analysis|||||||0.805
71647950|NCT00762411|142813107|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||Mixed Models Analysis|||||||0.893
71647951|NCT02959840|142813108|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.|||||<|1e-05|||||||Chi-squared|||||||< 0.00001
71647952|NCT02959840|142813108|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||5e-05|||||||Chi-squared|||||||0.00005
71647953|NCT02959840|142813108|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
71647954|NCT02959840|142813109|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
71647955|NCT02959840|142813109|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0002|||||||Chi-squared|||||||0.0002
71647956|NCT02959840|142813109|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.8|||||||Chi-squared|||||||0.8
71647957|NCT02959840|142813110|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||4e-05|||||||Chi-squared|||||||0.00004
71647958|NCT02959840|142813110|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
71647959|NCT02959840|142813110|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.09|||||||Chi-squared|||||||0.09
71647960|NCT02959840|142813111|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
71647961|NCT02959840|142813111|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
71647962|NCT02959840|142813111|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71647963|NCT02959840|142813112|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71647964|NCT02959840|142813112|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71647965|NCT02959840|142813112|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
71647966|NCT02959840|142813113|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||1|||||||Chi-squared|||||||1
71647967|NCT02959840|142813113|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
71647968|NCT02959840|142813113|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared|||||||0.1
71647969|NCT02959840|142813114|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared|||||||0.001
71647970|NCT02959840|142813114|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0004|||||||Chi-squared|||||||0.0004
71647971|NCT02959840|142813114|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
71647972|NCT02959840|142813115|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.008|||||||Chi-squared|||||||0.008
71647973|NCT02959840|142813115|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.07|||||||Chi-squared|||||||0.07
71647974|NCT02959840|142813115|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.6|||||||Chi-squared|||||||0.6
71647975|NCT02959840|142813116|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.2|||||||Chi-squared|||||||0.2
71647976|NCT02959840|142813116|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
71647977|NCT02959840|142813116|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.7|||||||Chi-squared|||||||0.7
71647978|NCT02959840|142813117|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
71647979|NCT02959840|142813117|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared|||||||1
71647980|NCT02959840|142813117|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared|||||||0.5
71647981|NCT02959840|142813118|SUPERIORITY|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.02|||||||Fisher Exact|||||||0.02
71647982|NCT02959840|142813118|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
71647983|NCT02959840|142813118|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.3|||||||Fisher Exact|||||||0.3
71647984|NCT02959840|142813119|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact|||||||0.2
71647985|NCT02959840|142813119|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.5|||||||Fisher Exact|||||||0.5
71647986|NCT02959840|142813119|EQUIVALENCE|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.7|||||||Fisher Exact|||||||0.7
71647987|NCT01680016|142813162|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years||1.02|0.69|
71647988|NCT01680016|142813163|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|1.09|||||TWO_SIDED|95.0|0.87|1.35|||ANOVA|||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years||1.35|0.87|
71647989|NCT00288704|142813175|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
71647990|NCT00288704|142813176|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||"Subjects received rilonacept 160 mg for 9 weeks (weeks 6-15), and then were re-randomized 1:1 into either Placebo or rilonacept 160 mg. The endpoint for the period was 9 weeks later (week 24).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.001
71647991|NCT00288704|142813177|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
71647992|NCT00288704|142813178|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison P-Value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71647993|NCT00288704|142813179|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value is a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<.0001
71647994|NCT00288704|142813180|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.0001
71647995|NCT00288704|142813181|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."||||<0.01
71647996|NCT00288704|142813182|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71647997|NCT00288704|142813183|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71647998|NCT00288704|142813184|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.||||<0.0001
71647999|NCT01579006|142813205|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648000|NCT01579006|142813206|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648001|NCT01579006|142813207|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648002|NCT01579006|142813209|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648003|NCT01579006|142813210|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648004|NCT01579006|142813216|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648005|NCT01579006|142813217|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648006|NCT01579006|142813218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648007|NCT01579006|142813219|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648008|NCT01579006|142813220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648009|NCT01579006|142813222|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||<0.0001
71648010|NCT02697617|142813224|SUPERIORITY|||||||0.024||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.024
71648011|NCT02697617|142813225|SUPERIORITY|||||||0.14||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.14
71648012|NCT02697617|142813227|OTHER||||||||||||||||||comparison by paired t-test|||
71648013|NCT02697617|142813228|SUPERIORITY|||||||0.15||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|Paired t-test|||||||0.15
71824262|NCT03613129|143152244|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.136|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.136
71648014|NCT02697617|142813229|SUPERIORITY|||||||0.4||||||First analyzed using a Linear Mixed Model to assess if there were carryover effects and then subsequently analyzed using paired t-tests to compare the mean differences between treatments.|paired t test|||||||0.4
71648015|NCT02733627|142813284|OTHER||Slope|3.8266|STANDARD_ERROR_OF_MEAN|0.2967|||TWO_SIDED|95.0|3.2155|4.4376||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.4376|3.2155|
71648016|NCT02733627|142813285|OTHER||Slope|4.181|STANDARD_ERROR_OF_MEAN|0.3247|||TWO_SIDED|95.0|3.5094|4.8527||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.8527|3.5094|
71648017|NCT02733627|142813286|OTHER||Slope|1.8868|STANDARD_ERROR_OF_MEAN|0.3069|||TWO_SIDED|95.0|1.2503|2.5234||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|2.5234|1.2503|
71648018|NCT02733627|142813287|OTHER||Slope|3.0677|STANDARD_ERROR_OF_MEAN|0.4844|||TWO_SIDED|95.0|2.0631|4.0723||||||The basic model for the investigation of dose proportionality was a power model. The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate. The assumption of a linear relationship between the log-transformed pharmacokinetic endpoint and the log-transformed dose was checked.|Standard Error of the mean is actually Standard Error of the slope. Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|4.0723|2.0631|
71648019|NCT00183196|142813288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|0.281|0.997|||Regression, Cox|||||.997|.281|
71648020|NCT00183196|142813288|SUPERIORITY|||||||0.04|||||||Regression, Cox|percent heavy drinking days at baseline was used as a covariate in the analysis as it was a predictor of overall survival independent of group.||||||0.04
71648021|NCT01721772|142813336|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.6|||Stratified Log Rank Test|||||0.60|0.30|<0.0001
71648022|NCT01721772|142813337|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.56|||Stratified Log Rank Test|||||0.56|0.34|<0.0001
71648023|NCT01721772|142813339|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.43|||<|0.0001|TWO_SIDED|95.0|2.75|7.13|||Cochran-Mantel-Haenszel|||||7.13|2.75|<0.0001
71648024|NCT01721772|142813340|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.37|||||TWO_SIDED|95.0|0.24|0.56|||||PD-L1 positive group|||0.56|0.24|
71648025|NCT01721772|142813340|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.8|||||PD-L1 negative group|||0.80|0.45|
71648026|NCT01721772|142813343|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.41|0.65||||||||0.65|0.41|
71824263|NCT03613129|143152244|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.009
71648027|NCT02542462|142813351|SUPERIORITY|||||||0.2||||||P value for the number of subjects with an increase of 1 mm or more of terminal ileum from pre to post was 0.2|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.2
71648028|NCT02542462|142813351|SUPERIORITY|||||||0.3||||||P value for change in the number of subjects with an increase in number of lymph nodes from pre to post was 0.3.|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes||||0.3
71648029|NCT05004649|142813366|OTHER|||||||0.024356||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.024356
71648030|NCT05004649|142813366|OTHER|||||||0.040382||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.040382
71648031|NCT05004649|142813366|OTHER|||||||0.90161||||||When Bonferroni corrected for multiple comparisons the significance level across conditions is p \< 0.0167. This is the Bonferonni corrected level for three tests applied to a baseline significance value of 0.05.|t-test, 2 sided|||||||.90161
71648032|NCT02654145|142813372|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.13|-0.66||p-value is for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|||-0.66|-1.13|<0.001
71648033|NCT02654145|142813372|SUPERIORITY||Mean Difference (Final Values)|-1.34|||<|0.001|TWO_SIDED|95.0|-1.68|-1.0||p- value for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used Xolair.|||-1.00|-1.68|<0.001
71648034|NCT02654145|142813374|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.47|||Generalised Estimating Equations||Analysis performed using generalized estimating equation (GEE) model assuming a negative binomial distribution with a covariate of treatment period (pre-treatment , on- and off-treatment), logarithm of time as an offset variable|||0.47|0.28|<0.001
71648035|NCT02637141|142813376|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|7.1||0.7271|TWO_SIDED|95.0|-16.82|11.83|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||11.83|-16.82|0.7271
71648036|NCT02637141|142813376|SUPERIORITY|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|6.39|STANDARD_ERROR_OF_MEAN|6.67||0.3438|TWO_SIDED|95.0|-7.07|19.85|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||19.85|-7.07|0.3438
71648037|NCT02637141|142813377|SUPERIORITY||LS Mean Difference|-14.32|STANDARD_ERROR_OF_MEAN|19.85||0.4746|TWO_SIDED|95.0|-54.39|25.74|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||25.74|-54.39|0.4746
71648038|NCT02637141|142813377|SUPERIORITY||LS Mean Difference|-41.24|STANDARD_ERROR_OF_MEAN|18.85||0.0343|TWO_SIDED|95.0|-79.28|-3.2|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.||||-3.2|-79.28|0.0343
71648039|NCT02637141|142813379|SUPERIORITY||LS Mean Difference|4402.25|STANDARD_ERROR_OF_MEAN|1717.4||0.014|TWO_SIDED|95.0|936.39|7868.1|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||7868.10|936.39|0.0140
71648040|NCT02637141|142813379|SUPERIORITY||LS Mean Difference|944.9|STANDARD_ERROR_OF_MEAN|1167.22||0.4228|TWO_SIDED|95.0|-1410.65|3300.44|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||3300.44|-1410.65|0.4228
71648041|NCT02637141|142813380|SUPERIORITY||LS Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|17.09||0.3034|TWO_SIDED|95.0|-16.68|52.29|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||52.29|-16.68|0.3034
71648042|NCT02637141|142813380|SUPERIORITY||LS Mean Difference|-6.92|STANDARD_ERROR_OF_MEAN|15.46||0.6569|TWO_SIDED|95.0|-38.11|24.28|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA||24.28|-38.11|0.6569
71648043|NCT02637141|142813380|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|26.77||0.6254|TWO_SIDED|95.0|-40.86|67.2|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgG||67.20|-40.86|0.6254
71648044|NCT02637141|142813380|SUPERIORITY||LS Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|21.66||0.8955|TWO_SIDED|95.0|-40.84|46.57|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP IgG||46.57|-40.84|0.8955
71648045|NCT02637141|142813381|SUPERIORITY||Ratio of LS Means|0.83|STANDARD_ERROR_OF_MEAN|0.11||0.161|TWO_SIDED|95.0|0.63|1.08|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||Analysis of Total Weekly Bowel Movements at Week 12||1.08|0.63|0.1610
71648046|NCT02637141|142813381|SUPERIORITY||Ratio of LS Means|1.03|STANDARD_ERROR_OF_MEAN|0.13||0.781|TWO_SIDED|95.0|0.81|1.32|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||||1.32|0.81|0.7810
71648047|NCT02637141|142813383|SUPERIORITY||LS Mean Difference|-13.44|STANDARD_ERROR_OF_MEAN|12.33||0.2761|TWO_SIDED|95.0|-37.66|10.77|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||10.77|-37.66|0.2761
71648048|NCT02637141|142813383|SUPERIORITY||LS Mean Difference|-2.62|STANDARD_ERROR_OF_MEAN|11.66||0.8221|TWO_SIDED|95.0|-25.51|20.27|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||20.27|-25.51|0.8221
71648049|NCT02637141|142813384|SUPERIORITY||LS Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|2.1||0.1908|TWO_SIDED|95.0|-6.89|1.3|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||1.3|-6.89|0.1908
71648050|NCT02637141|142813384|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.98||0.4088|TWO_SIDED|95.0|-5.53|2.25|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||||2.25|-5.53|0.4088
71702452|NCT01482221|142921889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.292||0.268|TWO_SIDED|95.0|0.78|2.447|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||2.447|0.780|0.268
71648051|NCT01943435|142813386|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|0.3||||0.73|TWO_SIDED|95.0|-1.5|2.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||2.2|-1.5|0.73
71824264|NCT03613129|143152244|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.451|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.451
71648052|NCT01943435|142813386|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|-2.1||||0.02|TWO_SIDED|95.0|-3.9|-0.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||-0.3|-3.9|0.02
71648053|NCT01943435|142813386|SUPERIORITY|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|2.4||||0.01|TWO_SIDED|95.0|0.6|4.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.||4.3|0.6|0.01
71648054|NCT01943435|142813387|SUPERIORITY||Mean Difference (Final Values)|87.0||||0.29|TWO_SIDED|95.0|-75.2|249.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||249.2|-75.2|0.29
71648055|NCT01943435|142813387|SUPERIORITY||Mean Difference (Final Values)|129.7||||0.1|TWO_SIDED|95.0|-27.2|286.6|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||286.6|-27.2|0.10
71648056|NCT01943435|142813387|SUPERIORITY||Mean Difference (Final Values)|-42.7||||0.61|TWO_SIDED|95.0|-205.4|120.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.||120.0|-205.4|0.61
71648057|NCT01943435|142813388|SUPERIORITY||Mean Difference (Final Values)|30.5||||0.03|TWO_SIDED|95.0|3.1|57.9|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||57.9|3.1|0.03
71824265|NCT03613129|143152244|NON_INFERIORITY|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.240
71648058|NCT01943435|142813388|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.16|TWO_SIDED|95.0|-7.6|45.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||45.0|-7.6|0.16
71648059|NCT01943435|142813388|SUPERIORITY||Mean Difference (Final Values)|11.8||||0.4|TWO_SIDED|95.0|-15.6|39.1|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities \>1.5 METs), while adjusting for randomization stratification factors.||39.1|-15.6|0.40
71648060|NCT01328782|142813408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.074||95.0|1.4|2.94|||ANOVA|||||2.94|1.40|0.074
71648061|NCT01328782|142813408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.556||||0.556||95.0|-1.12|2.08|||ANOVA|||||2.08|-1.12|0.556
71648062|NCT01328782|142813408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.244||95.0|-0.64|2.49|||ANOVA|||||2.49|-0.64|0.244
71648063|NCT01328782|142813409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.014|TWO_SIDED|95.0|0.38|3.25|||ANOVA|||||3.25|0.38|0.014
71648064|NCT01328782|142813409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.832||95.0|-1.3|1.61|||ANOVA|||||1.61|-1.30|0.832
71648065|NCT01328782|142813409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.027||95.0|0.2|3.12|||ANOVA|||||3.12|0.20|0.027
71648066|NCT01328782|142813410|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
71648067|NCT01328782|142813410|SUPERIORITY_OR_OTHER|||||||0.3767||95.0|||||Log Rank|||||||0.3767
71648068|NCT01328782|142813410|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
71648069|NCT01328782|142813411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.008||95.0|0.008|0.076|||ANOVA|||||0.076|0.008|0.008
71648070|NCT01328782|142813411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.078||95.0|-0.004|0.066|||ANOVA|||||0.066|-0.004|0.078
71648071|NCT01328782|142813411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.5321||95.0|-0.024|0.045|||ANOVA|||||0.045|-0.024|0.5321
71648072|NCT01328782|142813412|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71648073|NCT01328782|142813412|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71648074|NCT01328782|142813412|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Chi-squared|||||||0.499
71824266|NCT03613129|143152245|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.039|||||||t-test, 2 sided|||||||0.039
71824267|NCT03613129|143152245|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.191|||||||t-test, 2 sided|||||||0.191
71824268|NCT03613129|143152245|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.016|||||||t-test, 2 sided|||||||0.016
71648075|NCT04535986|142813413|SUPERIORITY||LS mean difference|0.0868|STANDARD_ERROR_OF_MEAN|0.0162|<|0.0001|TWO_SIDED|95.0|0.0551|0.1185||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1185|0.0551|<0.0001
71648076|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.252|0.309|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.309|0.252|<0.0001
71648077|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.143|0.087|<0.0001
71648078|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.082|0.139|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.139|0.082|<0.0001
71648079|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.249|0.306|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.306|0.249|<0.0001
71648080|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.083|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.140|0.083|<0.0001
71648081|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.096|0.152|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.152|0.096|<0.0001
71702453|NCT01482221|142921889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.303||0.909|TWO_SIDED|95.0|0.533|1.75|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.||1.750|0.533|0.909
71762738|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-1.88||||0.104|TWO_SIDED|90.0|-3.78|0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.02|-3.78|0.1040
71648082|NCT01559116|142813425|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.079|0.136|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.136|0.079|<0.0001
71648083|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.289|0.349|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.349|0.289|<0.0001
71648084|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.096|0.156|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.156|0.096|<0.0001
71648085|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.089|0.149|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.149|0.089|<0.0001
71648086|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.354|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.354|0.293|<0.0001
71648087|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.161|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.161|0.101|<0.0001
71648088|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.109|0.169|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.169|0.109|<0.0001
71648089|NCT01559116|142813426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.093|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.093|<0.0001
71648090|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.212|0.273|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.273|0.212|<0.0001
71648091|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.074|0.133|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.133|0.074|<0.0001
71648092|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.072|0.132|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.132|0.072|<0.0001
71648093|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.201|0.262|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.262|0.201|<0.0001
71648094|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.123|0.063|<0.0001
71648095|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.08|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.140|0.080|<0.0001
71648096|NCT01559116|142813427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.061|0.121|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.121|0.061|<0.0001
71648097|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.173|0.241|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.241|0.173|<0.0001
71648098|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.059|0.126|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.126|0.059|<0.0001
71648099|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.045|0.113|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.113|0.045|<0.0001
71648100|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.167|0.235|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.235|0.167|<0.0001
71648101|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.052|0.12|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.120|0.052|<0.0001
71648102|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.067|0.135|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.135|0.067|<0.0001
71648103|NCT01559116|142813428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.039|0.107|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.107|0.039|<0.0001
71702454|NCT01482221|142921890|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.505|TWO_SIDED|95.0|-2.29|1.13||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.13|-2.29|0.505
71648104|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.305|0.371|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.371|0.305|<0.0001
71648105|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.087|0.153|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.153|0.087|<0.0001
71648106|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.078|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.143|0.078|<0.0001
71648107|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.317|0.383|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.383|0.317|<0.0001
71648108|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.098|0.164|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.164|0.098|<0.0001
71648109|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.099|0.165|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.165|0.099|<0.0001
71648110|NCT01559116|142813429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.089|0.155|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.155|0.089|<0.0001
71824269|NCT03613129|143152245|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.053|||||||t-test, 2 sided|||||||0.053
71648111|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.389|0.477|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.477|0.389|<0.0001
71648112|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.166|0.253|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.253|0.166|<0.0001
71648113|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.133|0.221|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.221|0.133|<0.0001
71648114|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.396|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.352|0.441|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.441|0.352|<0.0001
71648115|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.129|0.217|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.217|0.129|<0.0001
71648116|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.115|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated. is calculated.|||0.203|0.115|<0.0001
71648117|NCT01559116|142813430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.096|0.184|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.184|0.096|<0.0001
71648118|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.417|0.509|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.|||0.509|0.417|<0.0001
71648119|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.154|0.246|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.246|0.154|<0.0001
71648120|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.225|0.133|<0.0001
71648121|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.443|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.396|0.49|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.490|0.396|<0.0001
71648122|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.134|0.227|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.227|0.134|<0.0001
71648123|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.125|0.218|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.218|0.125|<0.0001
71648124|NCT01559116|142813431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.113|0.206|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.206|0.113|<0.0001
71648125|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.355|0.453|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.453|0.355|<0.0001
71648126|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.17|0.267|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.267|0.170|<0.0001
71648127|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.126|0.223|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.223|0.126|<0.0001
71648128|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.301|0.4|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.400|0.301|<0.0001
71648129|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.117|0.214|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.214|0.117|<0.0001
71762739|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-1.51||||0.1924|TWO_SIDED|90.0|-3.41|0.4|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.40|-3.41|0.1924
71648130|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.099|0.197|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.197|0.099|<0.0001
71648131|NCT01559116|142813432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.170|0.072|<0.0001
71648132|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.274|0.385|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.385|0.274|<0.0001
71648133|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.115|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.225|0.115|<0.0001
71648134|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.066|0.176|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.176|0.066|<0.0001
71648135|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.251|0.363|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.363|0.251|<0.0001
71648136|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.092|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.092|<0.0001
71648137|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.111|0.222|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.222|0.111|<0.0001
71648138|NCT01559116|142813433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.043|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.154|0.043|<0.0001
71824270|NCT03613129|143152245|NON_INFERIORITY|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.06|||||||t-test, 2 sided|||||||0.060
71648139|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.408|0.516|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.516|0.408|<0.0001
71648140|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.105|0.212|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.212|0.105|<0.0001
71648141|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.098|0.205|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.205|0.098|<0.0001
71648142|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.452|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.398|0.507|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.|||0.507|0.398|<0.0001
71648143|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.095|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.|||0.203|0.095|<0.0001
71648144|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.|||0.216|0.107|<0.0001
71648145|NCT01559116|142813434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.087|0.196|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.|||0.196|0.087|<0.0001
71762740|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-1.94||||0.0928|TWO_SIDED|90.0|-3.84|-0.04|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.04|-3.84|0.0928
71824271|NCT03613129|143152246|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.587|||||||t-test, 2 sided|||||||0.587
71886420|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.4||||0.025|TWO_SIDED|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||56.88|0.96|0.0250
71824272|NCT03613129|143152246|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.618|||||||t-test, 2 sided|||||||0.618
71648146|NCT04610580|142813435|OTHER||Geometric Least Square Mean Ratio (%)|95.0|||||TWO_SIDED|90.0|82.1|110.0||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using analysis of variance (ANOVA) statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.0|82.1|
71648147|NCT04610580|142813436|OTHER||Geometric Least Square Mean Ratio (%)|96.243|||||TWO_SIDED|90.0|86.384|107.227||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||107.227|86.384|
71648148|NCT04610580|142813437|OTHER||Geometric Least Square Mean Ratio (%)|94.9|||||TWO_SIDED|90.0|81.6|110.5||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||110.5|81.6|
71648149|NCT04610580|142813438|OTHER||Geometric Least Square Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|70.6|145.1||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||145.1|70.6|
71648150|NCT04610580|142813439|OTHER||Geometric Least Square Mean Ratio (%)|99.1|||||TWO_SIDED|90.0|89.3|109.9||||||The formulation impact (12 × 1.25 mg EC mini-tablet versus 1 × 15 mg EC tablet) on plasma total Mo PK parameters was assessed using ANOVA statistical model with dosing period, treatment, and treatment sequence as the fixed effects and the participant (sequence) as a random effect, using the natural logarithms of the data.||109.9|89.3|
71648151|NCT01097694|142813445|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed.~The target enrollment was 60 assuming 10% drop-out for 54 completions which gave us 80% power to detect a doubling-dose change in PC20."||||<0.05
71648152|NCT01097694|142813446|SUPERIORITY||||||<|0.05|||||||Regression, Linear|Adjusted for baseline.||||||<0.05
71648153|NCT01097694|142813447|SUPERIORITY|||||||0.12|||||||Regression, Linear|Adjusted for baseline.||||||0.12
71648154|NCT01097694|142813448|SUPERIORITY|||||||0.1|||||||Regression, Linear|Adjusted for baseline.||||||0.10
71648155|NCT01097694|142813449|SUPERIORITY|||||||0.36|||||||Poisson regression model|||||||0.36
71648156|NCT01097694|142813450|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|adjusted for baseline values||For FEV1 we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||<0.05
71648157|NCT01097694|142813451|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Adjusted for baseline.||For FEV1% we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.||||0.06
71648158|NCT01097694|142813452|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|Adjusted for baseline||||||0.38
71648159|NCT01097694|142813453|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Adjusted for baseline.||||||0.31
71648160|NCT01097694|142813454|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
71648161|NCT01097694|142813455|SUPERIORITY|||||||0.31|||||||Regression, Linear|Adjusted for baseline.||||||0.31
71648162|NCT01097694|142813456|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline||||||0.11
71702455|NCT01482221|142921890|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.88||0.842|TWO_SIDED|95.0|-1.56|1.91||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.91|-1.56|0.842
71762741|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-2.06||||0.0745|TWO_SIDED|90.0|-3.96|-0.16|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.16|-3.96|0.0745
71648163|NCT01097694|142813457|SUPERIORITY|||||||0.62|||||||Regression, Linear|Adjusted for baseline.||||||0.62
71648164|NCT01097694|142813458|SUPERIORITY|||||||0.57|||||||Regression, Linear|Adjusted for baseline.||||||0.57
71648165|NCT01097694|142813459|SUPERIORITY|||||||0.15|||||||Regression, Linear|Adjusted for baseline||||||0.15
71648166|NCT01097694|142813460|SUPERIORITY|||||||0.33|||||||Regression, Linear|Adjusted for baseline.||||||0.33
71648167|NCT01097694|142813461|SUPERIORITY|||||||0.11|||||||Regression, Linear|Adjusted for baseline.||||||0.11
71648168|NCT01097694|142813462|SUPERIORITY|||||||0.07|||||||Regression, Linear|Adjusted for baseline.||||||0.07
71648169|NCT01097694|142813463|SUPERIORITY|||||||0.94|||||||Regression, Linear|Adjusted for baseline.||||||0.94
71648170|NCT01097694|142813464|SUPERIORITY|||||||0.13|||||||Regression, Linear|Adjusted for baseline||||||0.13
71648171|NCT01097694|142813465|SUPERIORITY|||||||0.25|||||||Regression, Linear|Adjusted for baseline||||||0.25
71648172|NCT01097694|142813466|SUPERIORITY|||||||0.54|||||||Regression, Linear|Adjusted for baseline.||||||0.54
71648173|NCT01097694|142813467|SUPERIORITY|||||||0.18|||||||Regression, Linear|Adjusted for baseline.||||||0.18
71648174|NCT01097694|142813468|SUPERIORITY|||||||0.56|||||||Regression, Linear|Adjusted for baseline.||||||0.56
71648175|NCT01097694|142813469|SUPERIORITY|||||||0.47|||||||Regression, Linear|Adjusted for baseline.||||||0.47
71648176|NCT02377349|142813473|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PT antibodies was greater than or equal to (≥) 1.5.|GMC ratio|8.47|||||TWO_SIDED|95.0|7.02|10.2|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||10.2|7.02|
71824273|NCT03613129|143152246|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.634|||||||t-test, 2 sided|||||||0.634
71824274|NCT03613129|143152246|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.355|||||||t-test, 2 sided|||||||0.355
71648177|NCT02377349|142813473|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-FHA antibodies was greater than or equal to (≥) 1.5.|GMC ratio|16.11|||||TWO_SIDED|95.0|13.48|19.24|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||19.24|13.48|
71648178|NCT02377349|142813473|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio \[dTpa Group-Mother/Control Group-Mother\] for anti-PRN antibodies was greater than or equal to (≥) 1.5.|GMC ratio|20.65|||||TWO_SIDED|95.0|15.86|26.88|||2-sample t-test|The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.||26.88|15.86|
71648179|NCT02004691|142813503|SUPERIORITY||Least Squares Mean Difference|19.008|STANDARD_ERROR_OF_MEAN|4.7576|=|0.0004|TWO_SIDED|95.0|9.319|28.696||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% Confidence Interval (CI) and p-values were based on mixed model for repeated measures approach with Baseline Derived % Predicted DLco adjusted for Hb and pressure, age, treatment group, visit, and study visit by treatment group as covariates.|||28.696|9.319|=0.0004
71648180|NCT02004691|142813505|SUPERIORITY||Least Squares Mean Difference|-39.927|STANDARD_ERROR_OF_MEAN|3.4957|<|0.0001|TWO_SIDED|95.0|-47.051|-32.803||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values were based on a mixed model for repeated measures approach with Baseline Spleen Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||-32.803|-47.051|<.0001
71648181|NCT02004691|142813507|SUPERIORITY||Least Squares Mean Difference|1.618|STANDARD_ERROR_OF_MEAN|3.3877|=|0.6364|TWO_SIDED|95.0|-5.302|8.538||Threshold for significance was 0.15.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Splenomegaly Related Score, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|||8.538|-5.302|=0.6364
71648182|NCT02004691|142813512|SUPERIORITY||Least Squares Mean Difference|-26.596|STANDARD_ERROR_OF_MEAN|3.5862|<|0.0001|TWO_SIDED|95.0|-33.911|-19.281||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Liver Volume (MN), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||-19.281|-33.911|<.0001
71648183|NCT02004691|142813513|SUPERIORITY||Least Squares Mean Difference|14.332|STANDARD_ERROR_OF_MEAN|5.7822|=|0.0185|TWO_SIDED|95.0|2.564|26.099||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline Platelets, Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||26.099|2.564|=0.0185
71824275|NCT03613129|143152246|NON_INFERIORITY|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.417|||||||t-test, 2 sided|||||||0.417
71648184|NCT02004691|142813514|SUPERIORITY||Least Squares Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.7384|=|0.94|TWO_SIDED|95.0|-1.566|1.454||Threshold for significance was 0.05.|Mixed model for repeated measures||The 95% CI and p-values are based on a mixed model for repeated measures approach with Baseline BFI item 3 (Worst Fatigue), Baseline age, treatment group, study visit, and study visit by treatment group interaction as covariates.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in an order the outcome measure were reported and continued when previous endpoint was statistically significant at two-sided 0.05.||1.454|-1.566|=0.9400
71824276|NCT03432533|143152248|NON_INFERIORITY|Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.84|TWO_SIDED|95.0|-1.3|1.0|||ANCOVA|||||1.0|-1.3|0.84
71648185|NCT01320722|142813517|SUPERIORITY|||||||0.72|||||||Repeated Measures Analysis|||Week 8||||0.72
71648186|NCT01320722|142813518|SUPERIORITY|||||||0.77||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.77
71648187|NCT01320722|142813519|SUPERIORITY|||||||0.57||||||Statistical significance was set for P\>0.05.|t-test, 2 sided|||Week 8||||0.57
71648188|NCT01320722|142813520|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||||||0.8
71648189|NCT01320722|142813520|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
71648190|NCT01320722|142813521|SUPERIORITY|||||||0.6|||||||Repeated Measures Analysis|||||||0.6
71824277|NCT01872611|143152269|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.2||0.671|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||1.3|0.7|0.671
71824278|NCT01872611|143152270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|0.2|0.7|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.7|0.2|0.001
71824279|NCT05096117|143152308|SUPERIORITY||Least Square Mean Difference|0.178||||0.784|TWO_SIDED||||||ANCOVA|||||||0.784
71648191|NCT01320722|142813521|SUPERIORITY|||||||0.7|||||||Repeated Measures Analysis|||||||0.7
71648192|NCT01320722|142813522|SUPERIORITY|||||||0.3|||||||Repeated Measures Analysis|||||||0.3
71648193|NCT01320722|142813522|SUPERIORITY|||||||0.1|||||||Repeated Measures Analysis|||||||0.1
71648194|NCT01320722|142813523|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|Statistical significance was set for a 2-tailed P \<0.05.||Week 8||||0.35
71648195|NCT01320722|142813523|SUPERIORITY|||||||0.7||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.7
71648196|NCT01320722|142813523|SUPERIORITY|||||||0.06||||||Statistical significance was set for a 2-tailed P \<0.05.|t-test, 2 sided|||Week 8||||0.06
71648197|NCT01320722|142813524|SUPERIORITY|||||||0.92||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall SBP||||0.92
71648198|NCT01320722|142813524|SUPERIORITY|||||||0.64||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Overall DBP||||0.64
71648199|NCT01320722|142813524|SUPERIORITY|||||||0.8||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Awake SBP||||0.80
71648200|NCT01320722|142813524|SUPERIORITY|||||||0.97||||||Statistical significance was set for P\>0.05.|Repeated Measures Analysis|||Asleep SBP at Week 8||||0.97
71824280|NCT01446003|143152326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02|||||TWO_SIDED|90.0|-0.52|4.56|||Linear mixed effect models|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||If the upper limit of the 90% confidence interval lies below the bound 5 mmHg, the hypothesis that change from baseline in ambulatory 24-hour mean SBP in participants with mild to moderate hypertension following 10 days of multiple dosing of MK-8457 is similar to placebo will be supported.||4.56|-0.52|
71824281|NCT01446003|143152327|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.57|||||TWO_SIDED|90.0|0.19|2.96|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||||2.96|0.19|
71648201|NCT01320722|142813524|SUPERIORITY|||||||0.34|||||||Repeated Measures Analysis|||Overall SBP||||0.34
71648202|NCT01320722|142813524|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysi|||Overall DBP||||0.59
71648203|NCT01320722|142813524|SUPERIORITY|||||||0.57|||||||Repeated Measures Analysis|||Awake SBF||||0.57
71648204|NCT01320722|142813524|SUPERIORITY|||||||0.08|||||||Repeated Measures Analysis|||Asleep SBP||||0.08
71648205|NCT01320722|142813524|SUPERIORITY|||||||0.59|||||||Repeated Measures Analysis|||Overall SBP||||0.59
71648206|NCT01320722|142813524|SUPERIORITY|||||||0.53|||||||Repeated Measures Analysis|||||||0.53
71824282|NCT01446003|143152328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|90.0|2.44|13.35|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after AM dosing||13.35|2.44|
71648207|NCT01320722|142813524|SUPERIORITY|||||||0.55|||||||Repeated Measures Analysis|||Awake SBP||||0.55
71648208|NCT01320722|142813524|SUPERIORITY|||||||0.8|||||||Repeated Measures Analysis|||Asleep SBP||||0.80
71648209|NCT01320722|142813525|SUPERIORITY|||||||0.98|||||||Repeated Measures Analysis|||||||0.98
71648210|NCT01320722|142813525|SUPERIORITY|||||||0.07|||||||Repeated Measures Analysis|||||||0.07
71648211|NCT01320722|142813525|SUPERIORITY|||||||0.97|||||||Repeated Measures Analysis|||||||0.97
71648212|NCT00021541|142813528|SUPERIORITY|||||||0.012|||||||Repeated measures ANOVA|||||||0.012
71648213|NCT00021541|142813528|OTHER|||||||0.015|||||||Repeated measures ANOVA|||Post hoc test: tipifarnib group F=7.40||||0.015
71648214|NCT00021541|142813528|OTHER|||||||0.66|||||||Repeated measures ANOVA|||Post hoc test: placebo group F=0.19||||0.66
71648215|NCT03828539|142813532|OTHER||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.13|0.27|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||0.27|0.13|<.001
71648216|NCT03828539|142813533|OTHER||Odds Ratio (OR)|2.76|||<|0.001|TWO_SIDED|95.0|2.06|3.71|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.71|2.06|<.001
71648217|NCT03828539|142813534|OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|3.12|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||||3.12|1.70|<.001
71648218|NCT03828539|142813535|OTHER||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.26|2.43|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Physical Component Summary (PCS)||2.43|1.26|<0.001
71648219|NCT03828539|142813535|OTHER||Odds Ratio (OR)|1.79||||0.005|TWO_SIDED|95.0|1.29|2.69|||Regression, Logistic|Odds ratio is obtained from a logistic regression model that includes treatment group and stratification factor (MMD at baseline)||Mental Component Summary (MCS)||2.69|1.29|0.005
71648220|NCT02616380|142813540|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
71648221|NCT02616380|142813541|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
71648222|NCT02616380|142813541|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
71648223|NCT02616380|142813541|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||<0.0001
71648224|NCT02616380|142813541|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
71648225|NCT02616380|142813542|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
71648226|NCT02616380|142813542|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
71648227|NCT02616380|142813543|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||<0.0001
71648228|NCT02616380|142813543|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||<0.0001
71648229|NCT02616380|142813543|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
71648230|NCT02616380|142813543|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
71648231|NCT02616380|142813544|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
71648232|NCT03407729|142813554|OTHER|Using seed-based analysis with a 1) Left Thalamus seed and 2) Left Middle Temporal Gyrus seed, cluster size was set at 50 voxels and p-value was thresholded at p\<0.05. This was used to compare the differences between the two study groups in terms of number of activated voxels during during cognitive testing using the N-back.|||||<|0.05||||||The a priori threshold for statistical significance was p\<0.05 and statistical power was set at a minimum of 0.80.|t-test, 2 sided|||||||<0.05
71648233|NCT03950674|142813568|OTHER||Hazard Ratio (HR)|0.62||||0.12511|TWO_SIDED|95.0|0.27|1.42||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.42|0.27|0.12511
71648234|NCT03950674|142813569|OTHER||Hazard Ratio (HR)|0.29||||0.03127|TWO_SIDED|95.0|0.07|1.15||One-sided p-value based on unstratified log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||1.15|0.07|0.03127
71648235|NCT00830167|142813577|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.78|-0.11||The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O'Brien-Fleming type alpha spending function of Lan and DeMets (1983).|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.11|-0.78|0.0046
71648236|NCT00830167|142813578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED|||||The analysis was conducted using 2-sided test with the significance level of 0.05.|Chi-squared|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.||||0.0078
71648237|NCT00830167|142813579|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.12|-5.85||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-5.85|-13.12|<0.0001
71648238|NCT00830167|142813580|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|1.88||0.9958|TWO_SIDED|95.0|1.29|8.68||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||8.68|1.29|0.9958
71648239|NCT00830167|142813581|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|1.92||0.0049|TWO_SIDED|95.0|-8.77|-1.21||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-1.21|-8.77|0.0049
71648240|NCT00830167|142813582|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.09||0.0007|TWO_SIDED|95.0|0.11|0.47||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.47|0.11|0.0007
71824283|NCT01446003|143152328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-5.68|3.81|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after PM dosing||3.81|-5.68|
71648241|NCT00830167|142813583|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|3.58|11.38||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||11.38|3.58|<0.0001
71648242|NCT00830167|142813584|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.31|STANDARD_ERROR_OF_MEAN|1.82||1|TWO_SIDED|95.0|7.74|14.87||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||14.87|7.74|1.0000
71648243|NCT00830167|142813585|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.35||0.0137|TWO_SIDED|95.0|-5.65|-0.33||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.33|-5.65|0.0137
71824284|NCT01446003|143152328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||||TWO_SIDED|90.0|0.81|9.71|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after AM dosing||9.71|0.81|
71648244|NCT00830167|142813586|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0687|TWO_SIDED|95.0|0.9|2.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|Regression, Logistic|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||2.35|0.90|0.0687
71824285|NCT01446003|143152328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||||TWO_SIDED|90.0|-4.55|1.17|||Linear mixed effects model|The model contained period and treatment as fixed effect, Day -1 baseline as a fixed continuous covariate, and participant as random effect.||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after PM dosing||1.17|-4.55|
71648245|NCT00830167|142813587|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.40|-1.06|<0.0001
71648246|NCT00830167|142813588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.52||0.0144|TWO_SIDED|95.0|-6.31|-0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.35|-6.31|0.0144
71648247|NCT00830167|142813589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0376|TWO_SIDED|95.0|-0.59|0.03||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.03|-0.59|0.0376
71648248|NCT00830167|142813590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.0052|TWO_SIDED|95.0|-1.12|-0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.15|-1.12|0.0052
71648249|NCT00830167|142813591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.4768|TWO_SIDED|95.0|-0.42|0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.40|-0.42|0.4768
71648250|NCT00830167|142813592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.0729|TWO_SIDED|95.0|-0.74|0.11||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.11|-0.74|0.0729
71648251|NCT00830167|142813593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.0238|TWO_SIDED|95.0|-0.81|0.0||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.00|-0.81|0.0238
71648252|NCT00830167|142813594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0075|TWO_SIDED|95.0|-0.89|-0.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.10|-0.89|0.0075
71648253|NCT00830167|142813595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.21||0.0023|TWO_SIDED|95.0|-1.01|-0.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-0.18|-1.01|0.0023
71648254|NCT00830167|142813596|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.2568|TWO_SIDED|95.0|-0.57|0.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.29|-0.57|0.2568
71648255|NCT00830167|142813597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.1011|TWO_SIDED|95.0|-0.72|0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.15|-0.72|0.1011
71648256|NCT00830167|142813598|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.4165|TWO_SIDED|95.0|-0.44|0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.35|-0.44|0.4165
71824286|NCT00318656|143152335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.02|STANDARD_ERROR_OF_MEAN|2.49||0.064||95.0|-0.32|10.36|||ANCOVA|Analysis of covariance (ANCOVA)|Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||10.36|-0.32|0.064
71648257|NCT00830167|142813599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|1.32||0.0006|TWO_SIDED|95.0|1.7|6.88||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||6.88|1.70|0.0006
71648258|NCT00830167|142813600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|1.84||0.1805|TWO_SIDED|95.0|-1.93|5.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.29|-1.93|0.1805
71824287|NCT00318656|143152336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|1.45||0.923||95.0|-3.37|2.85||P value von elteren (adjusted on sex)|ANCOVA||Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.||2.85|-3.37|0.923
71824288|NCT02806895|143152376|SUPERIORITY|||||||0.0062|||||||ANOVA|||||||0.0062
71824289|NCT02806895|143152377|SUPERIORITY|||||||0.0432|||||||ANOVA|||||||0.0432
71824290|NCT02806895|143152378|SUPERIORITY|||||||0.0414|||||||McNemar|||||||0.0414
71824291|NCT02806895|143152379|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
71824292|NCT02806895|143152380|SUPERIORITY|||||||0.1435|||||||McNemar|||||||0.1435
71824293|NCT02806895|143152381|SUPERIORITY|||||||0.1796|||||||McNemar|||||||0.1796
71824294|NCT02806895|143152382|SUPERIORITY|||||||0.1094|||||||McNemar|||||||0.1094
71648259|NCT00830167|142813601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|1.5||0.077|TWO_SIDED|95.0|-0.81|5.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.10|-0.81|0.0770
71648260|NCT00830167|142813602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|1.2||0.0648|TWO_SIDED|95.0|-0.54|4.19||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||4.19|-0.54|0.0648
71648261|NCT00830167|142813603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.94||0.2068|TWO_SIDED|95.0|-2.23|5.41||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.41|-2.23|0.2068
71648262|NCT00830167|142813604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.92||0.548|TWO_SIDED|95.0|-4.0|3.54||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||3.54|-4.00|0.5480
71648263|NCT00830167|142813605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|1.72||0.0052|TWO_SIDED|95.0|1.04|7.8||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||7.80|1.04|0.0052
71648264|NCT00830167|142813606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|1.39||0.0287|TWO_SIDED|95.0|-0.08|5.37||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||5.37|-0.08|0.0287
71648265|NCT00830167|142813607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.25||0.0262|TWO_SIDED|95.0|-0.97|0.01||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.01|-0.97|0.0262
71648266|NCT00830167|142813608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.83|0.27||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||0.27|-0.83|0.1561
71648267|NCT00830167|142813609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.04||0.0013|TWO_SIDED|95.0|-10.2|-2.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.||-2.18|-10.20|0.0013
71648268|NCT03201003|142813642|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.0001|TWO_SIDED|95.0|44.1|65.2|||Fisher Exact|||Treatment difference at 1000 mg||65.2|44.1|<0.0001
71648269|NCT03201003|142813643|SUPERIORITY||Risk Difference (RD)|58.9|||<|0.0001|TWO_SIDED|95.0|44.2|69.3|||Fisher Exact|||Treatment difference at 600 mg||69.3|44.2|<0.0001
71648270|NCT03201003|142813644|SUPERIORITY||Risk Difference (RD)|57.2|||<|0.0001|TWO_SIDED|95.0|41.2|69.1|||Fisher Exact|||Treatment difference at 300 mg||69.1|41.2|<0.0001
71648271|NCT03201003|142813645|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (with equally spaced scores) stratified by country||Treatment difference in Maximum Severity||||<0.0001
71648272|NCT00834613|142813646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.45||||||90.0|99.87|107.15|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.15|99.87|
71824295|NCT02806895|143152383|SUPERIORITY|||||||0.4531|||||||McNemar|||||||0.4531
71824296|NCT02806895|143152384|SUPERIORITY|||||||0.3593|||||||McNemar|||||||0.3593
71824297|NCT02806895|143152385|SUPERIORITY|||||||0.6072|||||||McNemar|||||||0.6072
71824298|NCT02806895|143152386|SUPERIORITY|||||||0.7905|||||||McNemar|||||||0.7905
71824299|NCT02806895|143152387|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71824300|NCT02806895|143152388|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71824301|NCT02806895|143152389|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71824302|NCT02806895|143152390|SUPERIORITY|||||||0.4116|||||||ANOVA|||||||0.4116
71824303|NCT02806895|143152391|SUPERIORITY|||||||0.1991|||||||ANOVA|||||||0.1991
71824304|NCT02806895|143152392|SUPERIORITY|||||||0.0806|||||||ANOVA|||||||0.0806
71824305|NCT02806895|143152393|SUPERIORITY|||||||0.9391|||||||ANOVA|||||||0.9391
71824306|NCT02806895|143152394|SUPERIORITY|||||||0.2116|||||||ANOVA|||||||0.2116
71824307|NCT02806895|143152395|SUPERIORITY|||||||0.1604|||||||ANOVA|||||||0.1604
71824308|NCT02806895|143152396|SUPERIORITY|||||||0.2144|||||||ANOVA|||||||0.2144
71824309|NCT02806895|143152397|SUPERIORITY|||||||0.0387|||||||ANOVA|||||||0.0387
71824310|NCT02806895|143152398|SUPERIORITY|||||||0.3426|||||||ANOVA|||||||0.3426
71824311|NCT02806895|143152399|SUPERIORITY|||||||0.1531|||||||ANOVA|||||||0.1531
71824312|NCT02806895|143152400|SUPERIORITY|||||||0.5603|||||||ANOVA|||||||0.5603
71824313|NCT02806895|143152401|SUPERIORITY|||||||0.4851|||||||ANOVA|||||||0.4851
71824314|NCT02806895|143152402|SUPERIORITY|||||||0.0241|||||||ANOVA|||||||0.0241
71824315|NCT02042443|143152418|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.05|TWO_SIDED|95.0|1.01|4.03|||Log Rank|||||4.03|1.01|0.05
71648273|NCT00834613|142813647|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.21|100.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.11|95.21|
71648274|NCT00834613|142813648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.22|100.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||100.1|95.22|
71648275|NCT00697619|142813658|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.370
71648276|NCT00697619|142813658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71648277|NCT00697619|142813658|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71648278|NCT00274625|142813671|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Fisher Exact|||||||0.60
71648279|NCT04556734|142813696|OTHER|F-test|LS Mean Difference|-14.14||||0.2579|TWO_SIDED|95.0|-38.933|10.648|||Mixed Models Analysis|||Mixed model for repeated measurements (MMRM) was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||10.648|-38.933|0.2579
71648280|NCT04556734|142813696|OTHER|F-test|LS Mean Difference|-21.79||||0.0592|TWO_SIDED|95.0|-44.446|0.871|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||0.871|-44.446|0.0592
71648281|NCT04556734|142813697|OTHER|F-test|Least square (LS) Mean Difference|-9.23||||0.1283|TWO_SIDED|95.0|-21.217|2.748|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||2.748|-21.217|0.1283
71648282|NCT04556734|142813697|OTHER|F-test|LS Mean Difference|-8.99||||0.1057|TWO_SIDED|95.0|-19.936|1.962|||Mixed Models Analysis|||MMRM was used for evaluation. The model included the treatment group, visit and treatment-by-visit interaction as fixed effects, disease duration and baseline SALT I score as covariates.||1.962|-19.936|0.1057
71648283|NCT04556734|142813698|OTHER||Response rate difference|11.5||||0.4067|TWO_SIDED|95.0|-14.22|37.31||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||37.31|-14.22|0.4067
71824316|NCT02735187|143152422|SUPERIORITY|A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.||||||0.6469||||||A probability (P-Value) above 0.05 is considered not to be statistical significant.|t-test, 2 sided|||||||0.6469
71886421|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0466|TWO_SIDED|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||5.45|1.00|0.0466
71648284|NCT04556734|142813698|OTHER||Response rate difference|17.5||||0.2171|TWO_SIDED|95.0|-8.23|43.19||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 30% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||43.19|-8.23|0.2171
71648285|NCT04556734|142813698|OTHER||Response rate difference|-0.8||||0.9425|TWO_SIDED|95.0|-23.18|21.48||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||21.48|-23.18|0.9425
71648286|NCT04556734|142813698|OTHER||Response rate difference|8.9||||0.4959|TWO_SIDED|95.0|-15.19|32.94||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 50% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo||32.94|-15.19|0.4959
71648287|NCT04556734|142813698|OTHER||Response rate difference|5.6||||0.3576|TWO_SIDED|95.0|-5.39|16.59||P-values are based on the comparison of Etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 2 mg and DB Treatment period: Placebo||16.59|-5.39|0.3576
71648288|NCT04556734|142813698|OTHER||Response rate difference|8.3||||0.2904|TWO_SIDED|95.0|-3.43|20.12||P-values were based on the comparison of etrasimod versus placebo.|Cochran-Mantel-Haenszel||Clopper-Pearson method|\>= 75% Improvement: Response rate difference was difference in response rates between DB Treatment period: Etrasimod 3 mg and DB Treatment period: Placebo.||20.12|-3.43|0.2904
71648289|NCT01993940|142813752|SUPERIORITY_OR_OTHER||Difference|18.9|STANDARD_ERROR_OF_MEAN|4.12|<|0.0001|TWO_SIDED|95.0|10.8|27.0||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||27.0|10.8|<0.0001
71648290|NCT01993940|142813753|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|0.92|1.88|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.88|0.92|<0.0001
71648291|NCT01993940|142813754|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|0.277|<|0.0001|TWO_SIDED|95.0|1.63|2.71|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.71|1.63|<0.0001
71648292|NCT01993940|142813755|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|0.7|1.61|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.61|0.70|<0.0001
71648293|NCT01993940|142813756|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.227||0.0011|TWO_SIDED|95.0|0.3|1.19|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.19|0.30|0.0011
71648294|NCT00550147|142813760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.125|STANDARD_ERROR_OF_MEAN|0.1933|<|0.05|TWO_SIDED|95.0|-1.52|-0.72|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.72|-1.52|<0.05
71648295|NCT00550147|142813761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.2056|<|0.05||95.0|-1.75|-0.91|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-0.91|-1.75|<0.05
71648296|NCT00550147|142813762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|13.06|<|0.05||95.0|-74.3|-20.2|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-20.2|-74.3|<0.05
71648297|NCT00550147|142813763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|STANDARD_ERROR_OF_MEAN|1.39|<|0.05|TWO_SIDED|95.0|-7.04|-1.29|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-1.29|-7.04|<0.05
71648298|NCT00550147|142813764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|2.16|<|0.05||95.0|-17.76|-8.82|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.||-8.82|-17.76|<0.05
71648299|NCT01567527|142813767|SUPERIORITY||Hazard Ratio (HR)|0.451|||<|0.0001|TWO_SIDED|95.0|0.299|0.678|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|Significance level 0.05.||0.678|0.299|< 0.0001
71648300|NCT01567527|142813767|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|2.22|||||TWO_SIDED|95.0|1.475|3.34|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||3.34|1.475|
71648301|NCT01567527|142813768|SUPERIORITY|Using a hierarchical procedure to preserve the overall Type I error rate at 0.05, after testing the primary outcome.|Percentage Difference (Final Values)|-24.6|||<|0.0001|TWO_SIDED|95.0|-36.7|-12.5|||Fisher Exact|||Statistical analysis for any mood episode||-12.5|-36.7|< 0.0001
71648302|NCT01567527|142813769|SUPERIORITY|Using mixed model repeated measures (MMRM) analysis with a restricted maximum likelihood (REML) approach. Analyses included the categorically fixed effects of treatment, region, trial week, and treatment-by-week interaction, as well as the continuously fixed covariates of baseline-score-by-week interaction. An unstructured covariance structure was used to model the within-subject errors and Kenward-Rodger degree of freedom was used to test the fixed effects.|Mean Difference (Final Values)|-0.43|||=|0.0011|TWO_SIDED|95.0|-0.69|-0.17|||Mixed model repeated measure analysis|||||-0.17|-0.69|= 0.0011
71648303|NCT01567527|142813770|SUPERIORITY||Hazard Ratio (HR)|0.137|||=|0.0002|TWO_SIDED|95.0|0.04|0.465|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|||0.465|0.04|= 0.0002
71648304|NCT01567527|142813770|SUPERIORITY|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|7.313|||||TWO_SIDED|95.0|2.151|24.865|||||HR is estimated for Placebo relative to Aripiprazole IM depot.|||24.865|2.151|
71648305|NCT01277510|142813790|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|35.5||||0.017|TWO_SIDED|95.0|8.76|62.24|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm's method at 0.05 should the primary endpoint achieve a significant result.||62.24|8.76|0.017
71824317|NCT05750745|143152478|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.0871|TWO_SIDED|95.0|-0.36|0.02|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test minus negative control.|||0.02|-0.36|0.0871
71824318|NCT05750745|143152479|SUPERIORITY||Adjusted Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|3.548||0.0972|TWO_SIDED|95.0|-0.78|13.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||13.20|-0.78|0.0972
71824319|NCT05750745|143152480|SUPERIORITY||Adjusted Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|3.16||0.0671|TWO_SIDED|95.0|-12.04|0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.41|-12.04|0.0671
71648306|NCT01277510|142813791|SUPERIORITY_OR_OTHER_LEGACY||Difference (Cinacalcet - Placebo)|3.46||||0.826|TWO_SIDED|95.0|-22.58|29.51|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -\<12 years old or 12 - \<18 years old).||The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||29.51|-22.58|0.826
71648307|NCT01277510|142813792|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.7||||0.147|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||1.3|-8.6|0.147
71648308|NCT01277510|142813793|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.3||||0.454|TWO_SIDED|95.0|-19.4|8.9|||ANCOVA|Baseline age group was used as covariate|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||8.9|-19.4|0.454
71648309|NCT01277510|142813794|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.0||||0.117|TWO_SIDED|95.0|-22.5|2.6|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was \> 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if \> 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.||2.6|-22.5|0.117
71648310|NCT01277510|142813795|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.896|TWO_SIDED|95.0|-3.1|3.6||No adjustments for multiplicity were made.|ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||3.6|-3.1|0.896
71648311|NCT01277510|142813797|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8||||0.854|TWO_SIDED|95.0|-9.4|7.9|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|||7.9|-9.4|0.854
71648312|NCT00784095|142813834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.047|TWO_SIDED|95.0|0.04|5.7|||Mixed Models Analysis|||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.7|.04|.047
71648313|NCT00784095|142813834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|||||TWO_SIDED|95.0|-1.1|4.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||4.7|-1.1|
71824320|NCT05750745|143152481|SUPERIORITY||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0673|TWO_SIDED|95.0|-0.27|0.01|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||0.01|-0.27|0.0673
71648314|NCT00784095|142813835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-3.2|5.6||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||5.6|-3.2|
71648315|NCT00784095|142813835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.6|3.3||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||3.3|-5.6|
71648316|NCT00784095|142813836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-6.2|2.9||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||2.9|-6.2|
71648317|NCT00784095|142813836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-8.2|1.0||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks||1.0|-8.2|
71648318|NCT00784095|142813837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.5|3.4||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.4|-4.5|
71648319|NCT00784095|142813837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-5.1|3.0||||||Intervention versus Attention Control at 8 weeks.||3.0|-5.1|
71648320|NCT00784095|142813838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-4.8|3.7||||||Intervention (Preparation and Completion) versus True Control at 8 weeks||3.7|-4.8|
71648321|NCT00784095|142813838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-1.9|6.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks.||6.7|-1.9|
71824321|NCT05750745|143152482|SUPERIORITY||Adjusted Mean Difference|2.38|STANDARD_ERROR_OF_MEAN|2.446||0.405|TWO_SIDED|95.0|-2.44|7.2|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as test minus negative control.|||7.20|-2.44|0.4050
71824322|NCT05750745|143152483|SUPERIORITY||Adjusted Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|2.656||0.0346|TWO_SIDED|95.0|-10.88|-0.41|||MMRM||Adjusted mean difference was calculated as test minus negative control.|||-0.41|-10.88|0.0346
71824323|NCT05750745|143152484|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.085||0.8256|TWO_SIDED|95.0|-0.15|0.19|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||0.19|-0.15|0.8256
71824324|NCT05750745|143152484|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.117||0.5314|TWO_SIDED|95.0|-0.16|0.3|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||0.30|-0.16|0.5314
71648322|NCT01540045|142813843|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.013
71648323|NCT01540045|142813844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.671|TWO_SIDED||||||t-test, 2 sided|||we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.671
71648324|NCT01540045|142813844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.694|TWO_SIDED||||||t-test, 2 sided|||we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy||||0.694
71648325|NCT01540045|142813845|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||0.118
71648326|NCT01540045|142813846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607|TWO_SIDED||||||McNemar|||Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).||||0.607
71648327|NCT01540045|142813847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to \< Sweet perception thresholds after chemotherapy||||0.015
71648328|NCT01540045|142813847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.010
71648329|NCT01540045|142813847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy||||0.004
71648330|NCT01540045|142813849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.28
71648331|NCT01540045|142813850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.889
71648332|NCT01540045|142813850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in functional role of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.293
71648333|NCT01540045|142813850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in emotional functioning of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.009
71648334|NCT01540045|142813850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in fatigue scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.213
71648335|NCT01540045|142813850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.595|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in appetite loss of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.595
71648336|NCT01540045|142813850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in constipation scale of quality of life between ≤ compared to \> umami recognition threshold after chemotherapy by EORT questionnaire||||0.068
71648337|NCT01540045|142813851|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71648338|NCT01540045|142813852|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||clinically significant|Wilcoxon (Mann-Whitney)|||change in peripheral neuropathy scale of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.240
71648339|NCT01540045|142813853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between \> ó = compared to \< umami recognition threshold after chemotherapy by EORT questionnaire||||0.036
71648340|NCT01540045|142813854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.312
71648341|NCT01540045|142813855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.608
71648342|NCT01540045|142813856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.035
71648343|NCT01540045|142813857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.||||0.402
71648344|NCT01540045|142813858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.109
71648345|NCT01540045|142813859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.||||0.092
71648346|NCT01540045|142813860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||McNemar|||We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)||||0.022
71648347|NCT00936351|142813861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
71648348|NCT02224053|142813872|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|106.66|||||TWO_SIDED|90.0|100.26|113.46|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||113.46|100.26|
71648349|NCT02224053|142813873|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|101.65|||||TWO_SIDED|90.0|94.65|109.16|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.||109.16|94.65|
71648350|NCT02224053|142813882|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.79|||||TWO_SIDED|90.0|88.77|101.21||||||AZ5104||101.21|88.77|
71648351|NCT02224053|142813882|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geomteric mean ratio|89.7|||||TWO_SIDED|90.0|83.89|95.91||||||AZ7550||95.91|83.89|
71648352|NCT02224053|142813883|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|102.32|||||TWO_SIDED|90.0|96.87|108.07|||||AZD9291+omeprazole / AZD9291 alone|AZ5104||108.07|96.87|
71648353|NCT02224053|142813883|NON_INFERIORITY_OR_EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.03|||||TWO_SIDED|90.0|89.92|98.33||||||AZ7550||98.33|89.92|
71648354|NCT01898598|142813896|SUPERIORITY_OR_OTHER||Difference in Clinical Response Rates|-21.8|||||TWO_SIDED|95.0|-71.6|32.1||||||The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.||32.1|-71.6|
71648355|NCT01898598|142813897|SUPERIORITY_OR_OTHER||Percentage Difference|-40.0|||||TWO_SIDED|95.0|-85.3|14.2||||||||14.2|-85.3|
71648356|NCT01499160|142813906|OTHER|Not done due to low accrual||||||||||||Not done due to low accrual|Not done due to low accrual|Not done due to low accrual||Not done due to low accrual|Not done due to low accrual|||
71648357|NCT00860262|142813911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-12.9|-8.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus Telmisartan 80 mg|||-8.3|-12.9|<0.0001
71648358|NCT00860262|142813911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.18||0.0002|TWO_SIDED|95.0|-6.7|-2.1|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.1|-6.7|0.0002
71648359|NCT00860262|142813912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-13.1|-8.2|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-8.2|-13.1|<0.0001
71648360|NCT00860262|142813912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.3|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.3|0.0001
71648361|NCT00860262|142813913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-12.6|-7.7|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-7.7|-12.6|<0.0001
71648362|NCT00860262|142813913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|1.24||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.4|-7.2|0.0001
71648363|NCT00860262|142813914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-10.2|-5.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-5.4|-10.2|<0.0001
71648364|NCT00860262|142813914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.0|-2.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-2.3|-7.0|0.0001
71648365|NCT00860262|142813915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg|||-4.0|-8.8|<0.0001
71648366|NCT00860262|142813915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.23||0.0077|TWO_SIDED|95.0|-5.7|-0.9|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg|||-0.9|-5.7|0.0077
71648367|NCT00593827|142813950|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|||||||0.03
71648368|NCT00593827|142813951|SUPERIORITY_OR_OTHER|||||||0.05|||||||Log Rank|||||||0.05
71648369|NCT00593827|142813954|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
71648370|NCT00688844|142813970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.655574|STANDARD_DEVIATION|8.060658||0.692782|||||||t-test, 2 sided|||Objective was to evaluate BMI across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.692782
71648371|NCT00688844|142813971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005401|STANDARD_DEVIATION|0.0243|<|0.001|||||||t-test, 2 sided|||Objective was to evaluate total body bone mineral density (BMD) one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||<0.001
71648372|NCT00688844|142813972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.419224|STANDARD_DEVIATION|3.4666||0.017941|||||||t-test, 2 sided|||Objective was to evaluate % lean mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.017941
71648373|NCT00688844|142813973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.208889|STANDARD_DEVIATION|3.51967||0.026009|||||||t-test, 2 sided|||Objective was to evaluate % fat mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.026009
71648374|NCT00688844|142813974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.5187|STANDARD_DEVIATION|362.9412||0.303864|||||||t-test, 2 sided|||Objective was to evaluate plasma phenylalanine across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.303864
71648375|NCT00688844|142813975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9549|STANDARD_DEVIATION|20.10814||0.00088|||||||t-test, 2 sided|||Objective was to evaluate protein intake (grams per day) across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.00088
71648376|NCT00688844|142813976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131676|STANDARD_DEVIATION|0.797247||0.3811|||||||t-test, 2 sided|||Objective was to evaluate dietary phenylalanine intake across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.||||0.3811
71648377|NCT01374451|142813978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.991||||0.488|TWO_SIDED|95.0|0.636|1.543|||Log Rank|||||1.543|0.636|0.488
71648378|NCT01994980|142814009|SUPERIORITY||||||<|0.01||||||This is a calculated p value.|Wilcoxon (Mann-Whitney)|||||||<0.01
71648379|NCT00096460|142814032|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|62.7|||||TWO_SIDED|95.0|43.8|89.6||||||||89.6|43.8|
71648380|NCT00096460|142814032|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Survival Probability|85.7||||||95.0|63.3|100.0||||||||100|63.3|
71648381|NCT02940522|142814057|OTHER|Comparison of bioavailability|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71648382|NCT02940522|142814058|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71648383|NCT02940522|142814059|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71648384|NCT02940522|142814060|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71648385|NCT02940522|142814061|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71648386|NCT02940522|142814062|OTHER|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.|||
71648387|NCT02846883|142814102|SUPERIORITY|These power estimates are based on linear regression of regulatory T-cell counts at each time point. These data will be summarized with the mean, median, standard deviation, standard error, minimum and maximum.|Mean Difference (Final Values)|81.0|||<|0.05|TWO_SIDED|95.0||||P value is adjusted for multiple comparisons|Regression, Cox|See above|Estimates for the differences in the secondary endpoints will be used to perform a power estimation using a Monte Carlo simulation method.|The primary statistical evaluation for Aim 1 will focus on the chronologically increasing counts of T-regulatory cells over time following MSC administration in both delivery groups. Using the pattern of increased counts with time and the standard deviation reported by Ito and colleagues in healthy subjects, 36 subjects provides 81.0% power to detect such a change.A p value of \<0.05 will be considered significant.||||<0.05
71648388|NCT00122447|142814168|SUPERIORITY_OR_OTHER||Slope|-0.941|STANDARD_ERROR_OF_MEAN|1.229||0.449|TWO_SIDED|95.0|-3.435|1.552||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||1.552|-3.435|0.449
71648389|NCT00122447|142814168|SUPERIORITY_OR_OTHER||Slope|-2.677|STANDARD_ERROR_OF_MEAN|1.211||0.034|TWO_SIDED|95.0|-5.133|-0.221||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||-0.221|-5.133|0.034
71648390|NCT00122447|142814168|SUPERIORITY_OR_OTHER||Slope|0.088|STANDARD_ERROR_OF_MEAN|1.21||0.943|TWO_SIDED|95.0|-2.367|2.542||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear|||||2.542|-2.367|0.943
71648391|NCT00122447|142814169|SUPERIORITY_OR_OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.012||0.943|TWO_SIDED|95.0|-0.025|0.023||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||Null hypothesis: no difference between active treatment group compared to placebo.||0.023|-0.025|0.943
71648392|NCT00122447|142814169|SUPERIORITY_OR_OTHER||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.28|TWO_SIDED|95.0|-0.012|0.039||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.039|-0.012|0.280
71648393|NCT00122447|142814169|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.313|TWO_SIDED|95.0|-0.012|0.037||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||||0.037|-0.012|0.313
71648394|NCT01453153|142814189|SUPERIORITY||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|60.0||||||||60|0|
71648395|NCT01453153|142814189|SUPERIORITY||percentage of participants|50.0|||||TWO_SIDED|95.0|7.0|93.0||||||||93|7|
71648396|NCT01453153|142814189|SUPERIORITY||percentage of participants|40.0|||||TWO_SIDED|95.0|19.0|64.0||||||||64|19|
71648397|NCT01453153|142814190|SUPERIORITY||percentage of participants|25.0|||||TWO_SIDED|95.0|1.0|81.0||||||||81|1|
71648398|NCT01453153|142814190|SUPERIORITY||percentage of participants|100.0|||||TWO_SIDED|95.0|40.0|100.0||||||||100|40|
71648399|NCT01453153|142814190|SUPERIORITY||percentage of participants|70.0|||||TWO_SIDED|95.0|46.0|88.0||||||||88|46|
71648400|NCT00799708|142814219|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||||||0.345
71648401|NCT00799708|142814219|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||ANOVA|||||||0.166
71648402|NCT00799708|142814220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.12|TWO_SIDED|90.0|-0.16|0.92|||ANCOVA|||||0.92|-0.16|0.120
71648403|NCT00880334|142814221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.939|TWO_SIDED|95.0|0.69|1.49|||Log Rank|||The study was designed with 80% power to detect 60% improvement in median PFS from 18 to 28.8 weeks (Vandetanib+docetaxel/Placebo+docetaxel hazard ratio of 0.625) with the addition of Vandetanib while maintaining an overall significance level of 5% in a one-sided test. This assumed exponential distribution of events, accrual of 1.75 patients per week (7-8 patients per month) for 78 weeks with 34 weeks of additional follow-up (112 weeks total). Full information was 118 PFS events.||1.49|0.69|0.939
71648404|NCT00880334|142814223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.873|TWO_SIDED|95.0|0.81|1.79|||Log Rank|||||1.79|0.81|.873
71648405|NCT00880334|142814224|SUPERIORITY_OR_OTHER|||||||0.56|||||||Fisher Exact|||||||0.56
71648406|NCT00880334|142814225|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher Exact|||||||0.31
71648407|NCT02153723|142814232|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|21.6||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
71648408|NCT02153723|142814233|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-2.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
71648409|NCT02153723|142814234|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|-0.1||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
71648410|NCT02153723|142814235|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|15.9||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
71648411|NCT02153723|142814236|OTHER|Wilcoxon signed rank sum test|Mean Difference (Final Values)|0.8||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71648412|NCT02153723|142814237|OTHER|Wilcoxon signed rank sum test|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
71648413|NCT02274558|142814245|OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.2|-2.0|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): valbenazine 80 mg vs. placebo.~* CGI-TD mean score: VBZ 80 mg vs. PBO.~* AIMS: VBZ 40 mg vs. PBO.~* CGI-TD: VBZ 40 mg vs. PBO.~For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.0|-4.2|<0.0001
71648414|NCT02274558|142814245|OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.0021|TWO_SIDED|95.0|-3.0|-0.7||Nominal P-value, not adjusted for multiplicity. See comments in above statistical analysis overview regarding the fixed-sequence testing procedure to control for multiplicity.|Mixed-effect Model Repeated Measures|||||-0.7|-3.0|0.0021
71648415|NCT02274558|142814246|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0742|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0742
71648416|NCT02274558|142814246|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.056|TWO_SIDED|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures|||||0.0|-0.5|0.0560
71648417|NCT02274558|142814247|OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.0200
71648418|NCT02274558|142814247|OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71648419|NCT02655224|142814248|SUPERIORITY|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|42.071|||<|0.0001|TWO_SIDED|95.0|5.113|346.181|||Fisher's Exact Test||Relugolix 40 mg/Placebo|||346.181|5.113|<0.0001
71648420|NCT02655224|142814249|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|29.176|||||TWO_SIDED|95.0|3.555|239.478|||||Relugolix 40 mg/Placebo|||239.478|3.555|
71648421|NCT02655224|142814250|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-1.05|0.069|||||Relugolix 40 mg-Placebo|||0.069|-1.050|
71648422|NCT02655224|142814251|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|11.96|||||TWO_SIDED|95.0|-3.201|27.112|||||Relugolix 40 mg-Placebo|||27.112|-3.201|
71648423|NCT02655224|142814252|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.625|||||TWO_SIDED|95.0|1.605|19.709|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||19.709|1.605|
71648424|NCT02655224|142814252|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|9.865|||||TWO_SIDED|95.0|2.784|34.955|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||34.955|2.784|
71648425|NCT02655224|142814253|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.438|||||TWO_SIDED|95.0|1.071|27.609|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56||27.609|1.071|
71648426|NCT02655224|142814253|OTHER|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|12.794|||||TWO_SIDED|95.0|2.603|62.88|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84||62.880|2.603|
71824325|NCT05750745|143152485|SUPERIORITY||Adjusted Mean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.99||0.5575|TWO_SIDED|95.0|-8.48|3.3|||van Elteren Test|P-value was from the Van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||3.30|-8.48|0.5575
71648427|NCT02655224|142814254|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|0.09|||||TWO_SIDED|95.0|-0.574|0.745|||||Relugolix 40 mg-Placebo|Day 1 to 28||0.745|-0.574|
71648428|NCT02655224|142814254|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.57|||||TWO_SIDED|95.0|-1.19|0.049|||||Relugolix 40 mg-Placebo|Day 29 to 56||0.049|-1.190|
71648429|NCT02655224|142814254|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.54|||||TWO_SIDED|95.0|-1.074|-0.012|||||Relugolix 40 mg-Placebo|Day 57 to 84||-0.012|-1.074|
71648430|NCT02655224|142814255|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|4.17|||||TWO_SIDED|95.0|-11.507|19.839|||||Relugolix 40 mg-Placebo|Day 1 to 28||19.839|-11.507|
71648431|NCT02655224|142814255|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|12.7|||||TWO_SIDED|95.0|-3.098|28.494|||||Relugolix 40 mg-Placebo|Day 29 to 56||28.494|-3.098|
71648432|NCT02655224|142814255|OTHER|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|11.6|||||TWO_SIDED|95.0|-3.554|26.745|||||Relugolix 40 mg-Placebo|Day 57 to 84||26.745|-3.554|
71648433|NCT04592419|142814269|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.0004|TWO_SIDED|95.02|-3.11|0.3|||Mixed Models Analysis|MMRM model with treatment, visit, treatment × visit interaction, baseline BCVA, disease duration, and geographical location as covariates.||||0.30|-3.11|.0004
71648434|NCT04592419|142814270|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept among BRVO participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.9||0.0243|TWO_SIDED|95.02|-4.24|-0.71|||Mixed Models Analysis|MMRM model treatment, visit, treatment × visit interaction, RVO subtype, baseline BCVA, disease duration, and geographical location as covariates.||||-0.71|-4.24|.0243
71648435|NCT04968925|142814347|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|4.24|||||TWO_SIDED|95.0|0.8|22.54|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||22.54|0.80|
71648436|NCT04968925|142814348|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|3.44|||||TWO_SIDED|95.0|1.16|10.16|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||10.16|1.16|
71648437|NCT04968925|142814349|NON_INFERIORITY|A non-inferiority margin of 10% was used.|Odds Ratio (OR)|2.67|||||TWO_SIDED|95.0|1.05|6.76|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|Phase I was not powered to test for non-inferiority for any endpoints. The data collected from this Phase was used to estimate the sample size required to achieve the primary endpoints for Phase II of the study.||6.76|1.05|
71648438|NCT04968925|142814350|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.76|||||TWO_SIDED|98.33|1.09|2.83|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.83|1.09|
71648439|NCT04968925|142814351|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.52|||||TWO_SIDED|96.66|1.02|2.28|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.28|1.02|
71648440|NCT04968925|142814352|SUPERIORITY|"The Fallback Method was used to test primary hypotheses in Phase II. An alpha of 0.167 was allocated for each test. Every successful test passed the unused alpha to the next."|Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.77|2.03|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control|It was calculated based on Phase I using Stroup's Method that 200 subjects were required to test superiority for each endpoint in Phase II.||2.03|0.77|
71648441|NCT00876265|142814364|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% CI or the difference between LS mean (Belotero) and LS mean (Zyplast) lies entirely above -Δ, noninferiority of Belotero will be concluded (first step). If, in addition, the CI lies entirely above 0, superiority of Belotero over Zyplast will be concluded (second step).|Adjusted (LS) mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.139||0.733|TWO_SIDED|95.0|-0.228|0.323||Treatment term and all significant (p ≤ 0.10) covariate and covariate by treatment interactions will be retained in the final ANCOVA model. From the final ANCOVA model, adjusted (LS) means for Belotero and Zyplast was computed.|ANCOVA|||"The null, H0, and the alternative hypothesis, H1, are as follows:~H0(1): adjusted mean(dadj\[i\]) ≤ -Δ versus H1(1): adjusted mean(dadj\[i\]) \> -Δ H0(2): adjusted mean(dadj\[i\]) ≤ 0 versus H1(2): adjusted mean(dadj\[i\]) \> 0 The sample size calculation was based on the following assumptions: Type I error α = 0.025 (one sided); Power = 90%; Non-inferiority margin Δ = 0.25; Estimated common standard deviation (SD) = 0.75. Under these assumptions, a total of 100 evaluable subjects were needed."||0.323|-0.228|0.733
71648442|NCT00487695|142814377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|95.0|||||Wilcoxon signed rank|||Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.||||0.01
71648443|NCT00487695|142814378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.||||0.89
71648444|NCT00487695|142814379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||wilcoxon signed rank test|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||0.002
71648445|NCT00487695|142814381|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).||||1.0
71648446|NCT00487695|142814382|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed-rank|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy||||<0.0001
71648447|NCT04542694|142814383|SUPERIORITY||The difference in proportions|0.1313||||0.0372|TWO_SIDED|95.0|-0.0004|0.2367|||Chi-squared|||A comparative analysis of the rate of clinical status improvement by 2 or more categories. The difference in percentages between the AREPLIVIR arm and the standard therapy arm (pa-pb)||0.2367|-0.0004|0.0372
71648448|NCT04542694|142814384|SUPERIORITY||The difference in days|4.0|||<|0.0001|TWO_SIDED||||||Log Rank|||Comparative analysis of time to clinical status improvement by categorical ordinal clinical improvement scale between the AREPLIVIR arm and the standard therapy arm||||<0.0001
71648449|NCT04542694|142814385|SUPERIORITY||The difference in percentages|22.5||||0.00016|TWO_SIDED||||||Chi-squared|||||||0.00016
71648450|NCT04542694|142814386|SUPERIORITY||Median Difference (Final Values)|1.55||||0.052|TWO_SIDED||||||Log Rank|||||||0.052
71648451|NCT04542694|142814387|SUPERIORITY|||||||0.1953|||||||Chi-squared|||||||0.1953
71648452|NCT04542694|142814388|SUPERIORITY|||||||0.4975|||||||Chi-squared|||||||0.4975
71824326|NCT05750745|143152485|SUPERIORITY||Adjusted Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|4.308||0.7717|TWO_SIDED|95.0|-9.6|7.37|||van Elteren Test|P-value was from the van Elteren test adjusted for Baseline Schiff sensitivity stratification factor.|Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||7.37|-9.60|0.7717
71648453|NCT01957150|142814400|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.46|||||TWO_SIDED|95.0|-0.97|0.06|||||Treatment comparison for overall weeks|||0.06|-0.97|
71648454|NCT01957150|142814401|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.47|||||TWO_SIDED|95.0|-1.17|0.24|||||Overall Weeks for Male|||0.24|-1.17|
71648455|NCT01957150|142814402|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.4|||||TWO_SIDED|95.0|-1.16|0.36|||||Overall Weeks for female|||0.36|-1.16|
71648456|NCT01957150|142814403|OTHER||Percentage Change from Baseline|-1.02|||||TWO_SIDED|95.0|-1.9|-0.13|||||Overall Weeks for Male|||-0.13|-1.90|
71648457|NCT01957150|142814404|OTHER||Percentage Change from Baseline|-0.05|||||TWO_SIDED|95.0|-0.87|0.78|||||Overall Weeks for female|||0.78|-0.87|
71648458|NCT01957150|142814405|OTHER||Percentage Change from Baseline|-0.51|||||TWO_SIDED|95.0|-1.11|0.1|||||Overall week|||0.10|-1.11|
71648459|NCT01207752|142814407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.550
71648460|NCT01632215|142814418|SUPERIORITY||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71648461|NCT04010227|142814446|SUPERIORITY||partial correlation|0.08||||0.6|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. multiply imputed data were used in analyses.||||0.40|-0.23|0.60
71648462|NCT04010227|142814447|SUPERIORITY||partial correlation|0.02||||0.96|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.34|-0.29|0.96
71648463|NCT04010227|142814448|SUPERIORITY||partial correlation|0.06||||0.75|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.75
71648464|NCT04010227|142814449|SUPERIORITY||partial correlation|0.09||||0.33|TWO_SIDED|95.0|-0.23|0.4||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.40|-0.23|0.33
71648465|NCT04010227|142814450|SUPERIORITY||partial correlation|0.03||||0.91|TWO_SIDED|95.0|-0.29|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.29|0.91
71648466|NCT04010227|142814451|SUPERIORITY||partial correlation|0.06||||0.74|TWO_SIDED|95.0|-0.25|0.38||P-value for study group x time interaction for patient physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.38|-0.25|0.74
71648467|NCT04010227|142814451|SUPERIORITY||partial correlation|0.14||||0.24|TWO_SIDED|95.0|-0.18|0.45||P-value for study group x time interaction for patient psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.45|-0.18|0.24
71648468|NCT04010227|142814451|SUPERIORITY||partial correlation|0.06||||0.78|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for patient existential quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.78
71648469|NCT04010227|142814451|SUPERIORITY||partial correlation|0.13||||0.29|TWO_SIDED|95.0|-0.19|0.44||P-value for study group x time interaction for patient social quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.44|-0.19|0.29
71648470|NCT04010227|142814452|SUPERIORITY||partial correlation|0.03||||0.92|TWO_SIDED|95.0|-0.28|0.35||P-value for study group x time interaction for caregiver physical quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.35|-0.28|0.92
71648471|NCT04010227|142814452|SUPERIORITY||partial correlation|0.06||||0.79|TWO_SIDED|95.0|-0.26|0.37||P-value for study group x time interaction for caregiver psychological quality of life. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 76. Multiply imputed data were used.||||0.37|-0.26|0.79
71648472|NCT04010227|142814453|SUPERIORITY||partial correlation|0.02||||0.94|TWO_SIDED|95.0|-0.3|0.34||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 144. Multiply imputed data were used.||||0.34|-0.30|0.94
71648473|NCT03922750|142814456|OTHER||Estimated mean treatment difference|1.01||||0.7542|TWO_SIDED|95.0|-5.33|7.35|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||7.35|-5.33|0.7542
71762742|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-1.01||||0.3836|TWO_SIDED|90.0|-2.91|0.9|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.90|-2.91|0.3836
71824327|NCT05750745|143152486|SUPERIORITY||Adjusted Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|3.235||0.818|TWO_SIDED|95.0|-5.63|7.12|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 6||7.12|-5.63|0.8180
71648474|NCT03922750|142814456|OTHER||Estimated mean treatment difference|7.88||||0.0107|TWO_SIDED|95.0|1.83|13.93|||ANCOVA|||The response and change from baseline in response during last two weeks of treatment (week 15 and 16) were analysed using an analysis of covariance (ANCOVA) model with treatment, pre-trial insulin treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values were imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset was analysed separately and estimates were combined using Rubin's rules.||13.93|1.83|0.0107
71648475|NCT01841073|142814478|SUPERIORITY|||||||0.005||||||p-value was calculated, and is not attempting to indicate the threshold for statistical significance|ANCOVA|||||||0.005
71648476|NCT01841073|142814479|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
71648477|NCT01841073|142814480|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
71648478|NCT04404907|142814493|OTHER|ANOVA||||||0.02|||||||ANOVA|||feel more attractive||||0.02
71648479|NCT04404907|142814493|OTHER|ANOVA||||||0.001|||||||ANOVA|||tanning helps relax||||0.001
71648480|NCT04404907|142814493|OTHER|||||||0.34|||||||ANOVA|||confident with a tan||||0.34
71648481|NCT04404907|142814493|OTHER|||||||0.0004|||||||ANOVA|||Social activity||||0.0004
71648482|NCT04404907|142814493|OTHER|||||||0.66|||||||ANOVA|||Important to protect skin from the sun||||0.66
71648483|NCT04404907|142814493|OTHER|||||||0.16|||||||ANOVA|||Concern about develop skin cancer||||0.16
71648484|NCT04404907|142814493|OTHER|||||||0.29|||||||ANOVA|||Chances of getting skin cancer are high||||0.29
71648485|NCT00702507|142814545|SUPERIORITY_OR_OTHER||Percentage of participants|29.2|||||TWO_SIDED|95.0|22.4|36.7|||||Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population|||36.7|22.4|
71648486|NCT00608634|142814582|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
71648487|NCT00608634|142814582|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71648488|NCT00608634|142814583|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71648489|NCT00749658|142814602|OTHER|Two tailed testing||||||0.07|||||||SAS|||||||0.07
71648490|NCT00633022|142814603|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4519|TWO_SIDED|95.0|-0.14|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.ANCOVA model, fitting fixed effect treatment term,|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg BID versus Placebo||0.06|-0.14|0.4519
71648491|NCT00633022|142814603|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.5789|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.06|-0.11|0.5789
71648492|NCT00633022|142814604|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.6986|TWO_SIDED|95.0|-0.15|0.1|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg twice daily versus placebo||0.10|-0.15|0.6986
71648493|NCT00633022|142814604|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo||0.12|-0.13|0.9486
71648494|NCT04388787|142814622|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71648495|NCT04388787|142814623|SUPERIORITY|||||||0.0008|||||||ANCOVA|||||||0.0008
71648496|NCT03298880|142814624|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.1|5.3|||mixed linear regression|||||5.3|2.1|<0.001
71648497|NCT03298880|142814624|SUPERIORITY||Mean Difference (Net)|2.3||||0.003|TWO_SIDED|95.0|0.8|3.8|||mixed linear regression|||||3.8|0.8|0.003
71648498|NCT00377572|142814638|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Maximum Symptom Day Comparison||||<0.001
71648499|NCT00377572|142814639|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||0.04
71648500|NCT00377572|142814640|SUPERIORITY_OR_OTHER|||||||0.1111||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept (to account for within-subject correlation) and visit and group as fixed effects.||||||0.1111
71648501|NCT00377572|142814641|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Childhood Asthma Control Test comparison||||0.007
71648502|NCT00377572|142814642|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Asthma Control Test comparison||||0.54
71648503|NCT00377572|142814643|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1 % of predicted value comparison||||0.30
71648504|NCT00377572|142814644|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1:FVC ×100 comparison||||0.81
71648505|NCT00377572|142814645|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||||||<0.0001
71648506|NCT00377572|142814646|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Percent Adherence Comparison||||0.12
71648507|NCT00377572|142814647|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 1- 2 (mild asthma) Percent Comparison||||0.001
71824328|NCT05750745|143152486|SUPERIORITY||Adjusted Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|3.834||0.3322|TWO_SIDED|95.0|-3.83|11.28|||MMRM||Adjusted mean difference was calculated as positive control minus negative control.|Change from Baseline at Week 12||11.28|-3.83|0.3322
71648508|NCT00377572|142814648|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 4 - 6 (severe asthma)percent comparison||||<0.001
71648509|NCT00377572|142814649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Inhaled glucocorticoids prescribed - mcg per day comparison||||<0.001
71648510|NCT00377572|142814650|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Comparison percent prescribed long-acting beta 2 agonists||||0.003
71648511|NCT00377572|142814651|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|Hospitalizations were summed over the course of the double-blind \& analyzed with logistic regression (LR) of 'any' vs. 'none'. The LR was unadjusted.||||||0.02
71648512|NCT00377572|142814652|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|Exacerbations were summed over the course of the double-blind and analyzed with an LR of 'any' versus 'none'. LR adjusted for study site and dosing.||||||<0.001
71648513|NCT00377572|142814653|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71648514|NCT00377572|142814654|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.58
71648515|NCT01705717|142814658|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Chi-squared|||||||0.034
71648516|NCT01705717|142814659|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Chi-squared|||||||0.007
71648517|NCT00769314|142814661|SUPERIORITY_OR_OTHER||Treatment difference|0.0685||||0.0419|TWO_SIDED|95.0|0.0025|0.1339||p-value \< 0.05 considered significant|Chi-squared||Treatment difference was the proportion of patients with aborted lesions in the acyclovir Lauriad group minus the proportion of patients with aborted lesions in the placebo group.|||0.1339|0.0025|0.0419
71648518|NCT00769314|142814662|SUPERIORITY_OR_OTHER|||||||0.0683||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0683
71648519|NCT00769314|142814663|SUPERIORITY_OR_OTHER|||||||0.0033||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0033
71648520|NCT00769314|142814664|SUPERIORITY_OR_OTHER|||||||0.0098||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0098
71648521|NCT00769314|142814665|SUPERIORITY_OR_OTHER|||||||0.8005||||||p-value \< 0.05 considered significant|Log Rank|||||||0.8005
71648522|NCT00769314|142814666|SUPERIORITY_OR_OTHER|||||||0.015||||||p-value \< 0.05 considered significant|Log Rank|||||||0.015
71648523|NCT00769314|142814667|SUPERIORITY_OR_OTHER|||||||0.0412||||||p-value \< 0.05 considered significant|Log Rank|||||||0.0412
71648524|NCT00769314|142814668|SUPERIORITY_OR_OTHER|||||||0.0271||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0271
71648525|NCT00769314|142814669|SUPERIORITY_OR_OTHER|||||||0.5695||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 1 timepoint.||||0.5695
71886422|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0007|TWO_SIDED|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||5.36|1.50|0.0007
71648526|NCT00769314|142814669|SUPERIORITY_OR_OTHER|||||||0.1824||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 3 timepoint||||0.1824
71648527|NCT00769314|142814669|SUPERIORITY_OR_OTHER|||||||0.0078||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 5 timepoint||||0.0078
71648528|NCT00769314|142814669|SUPERIORITY_OR_OTHER|||||||0.3303||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 7 timepoint||||0.3303
71648529|NCT00769314|142814669|SUPERIORITY_OR_OTHER|||||||0.6045||||||p-value \< 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 14 timepoint||||0.6045
71648530|NCT00769314|142814670|SUPERIORITY_OR_OTHER|||||||0.0022||||||p-value \< 0.05 considered significant|Chi-squared|||||||0.0022
71648531|NCT04980456|142814679|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, and sequence) and random (subject) effects. Difference = TOTAL30 minus Biofinity|||0.01||
71648532|NCT04832971|142814680|SUPERIORITY||Difference vs. Placebo at Week 24|-51.22|||<|0.0001|TWO_SIDED|95.0|-61.73|-40.7||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-40.70|-61.73|<.0001
71648533|NCT04832971|142814680|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
71648534|NCT04832971|142814680|SUPERIORITY||Difference vs Placebo at Week 24|-56.56|||<|0.0001|TWO_SIDED|95.0|-67.09|-46.04||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures (MMRM)||ARO-ANG3 - Placebo|||-46.04|-67.09|<.0001
71648535|NCT04832971|142814680|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
71648536|NCT04832971|142814680|SUPERIORITY||Difference vs. Placebo at Week 24|-63.11|||<|0.0001|TWO_SIDED|95.0|-73.56|-52.66||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Model with Repeated Measures|||||-52.66|-73.56|<.0001
71824329|NCT00783692|143152509|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.8||||0.0206|TWO_SIDED|95.0|1.2|14.3||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||14.3|1.2|0.0206
71648537|NCT04832971|142814680|SUPERIORITY||||||<|0.0001||||||The adjusted p-value is calculated using the Holm method for multiplicity adjustment.|Holm method|||||||<.0001
71648538|NCT04832971|142814682|SUPERIORITY||Difference vs. Placebo at Week 24|-29.2|||<|0.0001|TWO_SIDED|95.0|-38.5|-20.0||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-20.0|-38.5|<.0001
71648539|NCT04832971|142814682|SUPERIORITY||Difference vs. Placebo at Week 24|-28.7|||<|0.0001|TWO_SIDED|95.0|-37.9|-19.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-19.5|-37.9|<.0001
71648540|NCT04832971|142814682|SUPERIORITY||Difference vs. Placebo at Week 24|-36.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-27.2||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-27.2|-45.5|<.0001
71648541|NCT04832971|142814684|SUPERIORITY||Difference vs. Placebo at Week 24|-18.66|||<|0.0001|TWO_SIDED|95.0|-26.53|-10.8||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-10.80|-26.53|<.0001
71648542|NCT04832971|142814684|SUPERIORITY||Difference vs. Placebo at Week 24|-15.18||||0.0002|TWO_SIDED|95.0|-23.0|-7.36||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-7.36|-23.00|0.0002
71648543|NCT04832971|142814684|SUPERIORITY||Difference vs. Placebo at Week 24|-21.9|||<|0.0001|TWO_SIDED|95.0|-29.69|-14.12||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-14.12|-29.69|<.0001
71648544|NCT04832971|142814686|SUPERIORITY||Difference vs. Placebo at Week 24|-16.0||||0.0138|TWO_SIDED|95.0|-28.7|-3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.3|-28.7|0.0138
71648545|NCT04832971|142814686|SUPERIORITY||Difference vs Placebo at Week 24|-9.3||||0.148|TWO_SIDED|95.0|-22.0|3.3||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repated Measures|||||3.3|-22.0|0.1480
71648546|NCT04832971|142814686|SUPERIORITY||Difference vs Placebo at Week 24|-20.2||||0.0019|TWO_SIDED|95.0|-32.8|-7.5||Model includes treatment arm, study visit, and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mxed Models Repeated Measures|||||-7.5|-32.8|0.0019
71648547|NCT04832971|142814688|SUPERIORITY||Difference vs Placebo|-54.26|||<|0.0001|TWO_SIDED|95.0|-62.11|-46.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|mixed Models Repeated Measures|||||-46.40|-62.11|<.0001
71648548|NCT04832971|142814688|SUPERIORITY||Difference vs Placebo at Week 24|-69.76|||<|0.0001|TWO_SIDED|95.0|-77.58|-61.95||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-61.95|-77.58|<.0001
71648549|NCT04832971|142814688|SUPERIORITY||Difference vs Placebo at Week 24|-73.69|||<|0.0001|TWO_SIDED|95.0|-81.44|-65.93||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-65.93|-81.44|<.0001
71648550|NCT04832971|142814690|SUPERIORITY||Difference vs Placebo at Week 24|-12.0||||0.0039|TWO_SIDED|95.0|-20.2|-3.9||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-3.9|-20.2|0.0039
71648551|NCT04832971|142814690|SUPERIORITY||Difference vs Placebo at Week 24|-21.6|||<|0.0001|TWO_SIDED|95.0|-29.8|-13.4||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-13.4|-29.8|<.0001
71702456|NCT01482221|142921890|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.89||0.788|TWO_SIDED|95.0|-1.98|1.51||Analysis for change in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||1.51|-1.98|0.788
71648552|NCT04832971|142814690|SUPERIORITY||Differeence vs Placebo at week 24|-24.5|||<|0.0001|TWO_SIDED|95.0|-32.6|-16.5||Model includes treatment arm, study visit, randomization stratification factor (LDL-C at Screening \[≥100 mg/dL vs \<100 mg/dL\]),and baseline value as model terms. Model also includes treatment by visit and treatment by baseline as interaction terms.|Mixed Models Repeated Measures|||||-16.5|-32.6|<.0001
71648553|NCT00706719|142814706|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.118
71648554|NCT00706719|142814706|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.006
71648555|NCT00706719|142814706|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.009
71648556|NCT00706719|142814706|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.0024
71648557|NCT00706719|142814707|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Baseline.||||0.15
71648558|NCT00706719|142814707|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 3.||||0.0067
71648559|NCT00706719|142814707|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 6.||||0.10
71648560|NCT00706719|142814707|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.26
71648561|NCT00706719|142814708|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.880
71648562|NCT00706719|142814708|SUPERIORITY_OR_OTHER|||||||0.612|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.612
71648563|NCT00706719|142814708|SUPERIORITY_OR_OTHER|||||||0.488|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.488
71648564|NCT00706719|142814708|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.054
71648565|NCT00706719|142814709|SUPERIORITY_OR_OTHER|||||||0.705|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.705
71648566|NCT00706719|142814709|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.013
71648567|NCT00706719|142814709|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.004
71648568|NCT00706719|142814709|SUPERIORITY_OR_OTHER|||||||0.808|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.808
71648569|NCT00706719|142814710|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.||||0.008
71648570|NCT00706719|142814710|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.||||0.015
71648571|NCT00706719|142814710|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.||||0.003
71648572|NCT00706719|142814710|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).||||0.109
71648573|NCT02951195|142814725|SUPERIORITY||LS Mean Difference|6.4||||0.0207|TWO_SIDED|95.0|0.3|12.6|||Mixed-effects Model for Repeated Measure|||||12.6|0.3|0.0207
71648574|NCT02951195|142814725|SUPERIORITY||LS Mean Difference|10.5||||0.0002|TWO_SIDED|95.0|5.0|15.9|||Mixed-effects Model for Repeated Measure|||||15.9|5.0|0.0002
71648575|NCT02951195|142814725|SUPERIORITY||LS Mean Difference|8.8||||0.0019|TWO_SIDED|95.0|3.0|14.5|||Mixed-effects Model for Repeated Measure|||||14.5|3.0|0.0019
71648576|NCT02951195|142814725|SUPERIORITY||LS Mean Difference|8.3||||0.054|TWO_SIDED|95.0|-2.1|18.7|||Mixed-effects Model for Repeated Measure|||||18.7|-2.1|0.0540
71648577|NCT02951195|142814726|SUPERIORITY||LS Mean Difference|8.7||||0.0007|TWO_SIDED|95.0|3.7|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.7|0.0007
71648578|NCT02951195|142814727|SUPERIORITY||Least Squares (LS) Mean Difference|-19.5||||0.0018|TWO_SIDED|95.0|-32.2|-6.8|||Mixed-effects Model for Repeated Measure|||||-6.8|-32.2|0.0018
71648579|NCT02951195|142814727|SUPERIORITY||LS Mean Difference|-13.6||||0.0106|TWO_SIDED|95.0|-25.0|-2.1|||Mixed-effects Model for Repeated Measure|||||-2.1|-25.0|0.0106
71648580|NCT02951195|142814727|SUPERIORITY||LS Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-38.6|-16.3|||Mixed-effects Model for Repeated Measure|||||-16.3|-38.6|<0.0001
71648581|NCT02951195|142814727|SUPERIORITY||LS Mean Difference|-24.8||||0.0017|TWO_SIDED|95.0|-40.0|-9.7|||Mixed-effects Model for Repeated Measure|||||-9.7|-40.0|0.0017
71648582|NCT02951195|142814728|SUPERIORITY||LS Mean Difference|-23.9|||<|0.0001|TWO_SIDED|95.0|-33.7|-14.1|||Mixed-effects Model for Repeated Measure|||||-14.1|-33.7|<0.0001
71648583|NCT02951195|142814729|SUPERIORITY||LS Mean Difference|12.5||||0.0166|TWO_SIDED|95.0|1.1|24.0|||Mixed-effects Model for Repeated Measure|||||24.0|1.1|0.0166
71648584|NCT02951195|142814729|SUPERIORITY||LS Mean Difference|21.3|||<|0.0001|TWO_SIDED|95.0|11.2|31.4|||Mixed-effects Model for Repeated Measure|||||31.4|11.2|<0.0001
71648585|NCT02951195|142814729|SUPERIORITY||LS Mean Difference|17.1||||0.0013|TWO_SIDED|95.0|6.3|27.8|||Mixed-effects Model for Repeated Measure|||||27.8|6.3|0.0013
71648586|NCT02951195|142814729|SUPERIORITY||LS Mean Difference|14.5||||0.0563|TWO_SIDED|95.0|-3.8|32.9|||Mixed-effects Model for Repeated Measure|||||32.9|-3.8|0.0563
71648587|NCT02951195|142814730|SUPERIORITY||LS Mean Difference|13.6||||0.0012|TWO_SIDED|95.0|5.3|21.9|||Mixed-effects Model for Repeated Measure|||||21.9|5.3|0.0012
71648588|NCT02951195|142814731|SUPERIORITY||LS Mean Difference|14.1||||0.0476|TWO_SIDED|95.0|-2.6|30.9|||ANCOVA|||||30.9|-2.6|0.0476
71648589|NCT02951195|142814731|SUPERIORITY||LS Mean Difference|29.4||||0.0001|TWO_SIDED|95.0|14.8|44.0|||ANCOVA|||||44.0|14.8|0.0001
71648590|NCT02951195|142814731|SUPERIORITY||LS Mean Difference|26.2||||0.0006|TWO_SIDED|95.0|11.3|41.1|||ANCOVA|||||41.1|11.3|0.0006
71648591|NCT02951195|142814731|SUPERIORITY||LS Mean Difference|4.8||||0.2714|TWO_SIDED|95.0|-11.6|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|-11.6|0.2714
71648592|NCT02951195|142814732|SUPERIORITY||LS Mean Difference|11.3||||0.0138|TWO_SIDED|95.0|1.3|21.2|||Mixed-effects Model for Repeated Measure|||||21.2|1.3|0.0138
71648593|NCT02754492|142814757|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.950|
71648594|NCT02754492|142814757|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71648595|NCT02754492|142814757|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71648596|NCT02754492|142814758|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.989|STANDARD_ERROR_OF_MEAN|0.0107|||ONE_SIDED|95.0|0.95|||||||Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.950|
71648597|NCT02754492|142814758|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71648598|NCT02754492|142814758|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71648599|NCT04561115|142814780|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.948|||||TWO_SIDED|90.0|0.926|0.972||||||||0.972|0.926|
71648600|NCT04561115|142814781|EQUIVALENCE|The relative alpha level for statistical significance was 0.1 (alpha=0.05 for one-sided test), or a 90% CI was used for the bioequivalence test.|Geometric Least Square Mean Ratio|0.978|||||TWO_SIDED|90.0|0.937|1.021||||||||1.021|0.937|
71648601|NCT01332968|142814814|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.0012|TWO_SIDED|95.0|0.51|0.85|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.85|0.51|0.0012
71648602|NCT01332968|142814815|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.||||0.93|0.64|0.0055
71648603|NCT01332968|142814816|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0028|TWO_SIDED|95.0|0.65|0.91|||Log Rank|||||0.91|0.65|0.0028
71648604|NCT01332968|142814817|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0118|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||||0.93|0.56|0.0118
71648605|NCT01332968|142814818|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0038||95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0038
71648606|NCT01332968|142814819|SUPERIORITY||Absolute difference in %|1.8||||0.3|TWO_SIDED|95.0|-2.02|5.68|||Log Rank|||Without PET||5.68|-2.02|0.30
71648607|NCT01332968|142814819|SUPERIORITY||Absolute difference in %|4.3||||0.17|TWO_SIDED|95.0|-1.8|10.5|||Log Rank|||With PET||10.5|-1.8|0.17
71648608|NCT01332968|142814820|SUPERIORITY||Absolute difference in %|1.6||||0.33|TWO_SIDED|95.0|-2.0|5.3|||Log Rank|||Without PET||5.3|-2.0|0.33
71648609|NCT01332968|142814820|SUPERIORITY||Absolute difference in %|3.5||||0.17|TWO_SIDED|95.0|-2.3|9.4|||Log Rank|||With PET||9.4|-2.3|0.17
71648610|NCT01332968|142814821|SUPERIORITY||Absolute difference in %|-5.5||||0.02|TWO_SIDED|95.0|-10.2|-0.78|||Log Rank|||Without PET||-0.78|-10.2|0.02
71648611|NCT01332968|142814821|SUPERIORITY||Absolute difference in %|5.2||||0.32|TWO_SIDED|95.0|-2.8|13.3|||Log Rank|||With PET||13.3|-2.8|0.32
71648612|NCT01332968|142814822|SUPERIORITY||Absolute difference in %|-4.9||||0.02||95.0|-9.3|0.6|||Log Rank|||Without PET||0.6|-9.3|0.02
71648613|NCT01332968|142814822|SUPERIORITY||Absolute difference in %|4.1||||0.33||95.0|-3.6|11.8|||Log Rank|||With PET||11.8|-3.6|0.33
71648614|NCT01332968|142814823|SUPERIORITY||Absolute difference in %|3.3||||0.052|TWO_SIDED|95.0|-0.19|6.85|||Log Rank|||Without PET||6.85|-0.19|0.052
71648615|NCT01332968|142814823|SUPERIORITY||Absolute difference in %|3.3||||0.3|TWO_SIDED|95.0|-2.3|8.9|||Log Rank|||With PET||8.9|-2.3|0.30
71648616|NCT01332968|142814824|SUPERIORITY||Absolute difference in %|3.2||||0.049|TWO_SIDED|95.0|-0.3|6.6|||Log Rank|||Without PET||6.6|-0.3|0.049
71648617|NCT01332968|142814824|SUPERIORITY||Absolute difference in %|3.9||||0.22|TWO_SIDED|95.0|-1.7|9.5|||Log Rank|||With PET||9.5|-1.7|0.22
71648618|NCT01332968|142814825|SUPERIORITY||Absolute difference in %|1.7||||0.58|TWO_SIDED|95.0|-3.5|6.8|||Log Rank|||Without PET||6.8|-3.5|0.58
71648619|NCT01332968|142814825|SUPERIORITY||Absolute difference in %|11.7||||0.006|TWO_SIDED|95.0|3.9|19.4|||Log Rank|||||19.4|3.9|0.006
71648620|NCT01332968|142814826|SUPERIORITY||Absolute difference in %|0.7||||0.8|TWO_SIDED|95.0|-4.0|5.5|||Log Rank|||Without PET||5.5|-4.0|0.80
71648621|NCT01332968|142814826|SUPERIORITY||Absolute difference in %|10.1||||0.009||95.0|2.6|17.6|||Log Rank|||With PET||17.6|2.6|0.009
71648622|NCT01332968|142814827|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3577||95.0|0.63|1.18|||Log Rank|||||1.18|0.63|0.3577
71648623|NCT01332968|142814828|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.25||95.0|0.58|1.16|||Log Rank|||||1.16|0.58|0.25
71648624|NCT01332968|142814829|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0015|TWO_SIDED|95.0|0.62|0.89|||Log Rank|||||0.89|0.62|0.0015
71648625|NCT01332968|142814830|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0004||95.0|0.56|0.85|||Log Rank|||||0.85|0.56|0.0004
71648626|NCT01332968|142814831|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.71|1.27|||Log Rank|||||1.27|0.71|
71648627|NCT01332968|142814832|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.5|1.19||||||||1.19|0.50|
71648628|NCT01332968|142814833|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.93|||Log Rank|||||0.93|0.63|
71648629|NCT01332968|142814834|SUPERIORITY||Hazard Ratio (HR)|0.69||||||95.0|0.55|0.88||||||||0.88|0.55|
71648630|NCT01332968|142814835|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.001|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.001
71648631|NCT01332968|142814836|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004||95.0|0.54|0.89|||Log Rank|||||0.89|0.54|0.004
71648632|NCT03480022|142814845|SUPERIORITY||||||<|0.002|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.002
71886423|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97|||<|0.0001|TWO_SIDED|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||5.18|1.70|<0.0001
71648633|NCT03480022|142814846|SUPERIORITY||||||<|0.006|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.006
71648634|NCT03480022|142814847|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures nested design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.001
71648635|NCT03480022|142814848|SUPERIORITY||||||<|0.002|||||||ANOVA|one-way ANOVA||||||<0.002
71648636|NCT03480022|142814849|SUPERIORITY||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||||||<0.007
71648637|NCT03480022|142814850|SUPERIORITY||||||<|0.049|||||||Wilcoxon (Mann-Whitney)|||||||<0.049
71648638|NCT03480022|142814851|SUPERIORITY||||||<|0.011|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.011
71648639|NCT03480022|142814852|SUPERIORITY||||||<|0.038|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.038
71648640|NCT03480022|142814853|SUPERIORITY||||||<|0.048|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.048
71648641|NCT03480022|142814854|SUPERIORITY||||||<|0.018|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.018
71648642|NCT03480022|142814855|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
71648643|NCT03480022|142814856|SUPERIORITY||||||<|0.034|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.034
71648644|NCT03480022|142814857|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
71648645|NCT03480022|142814858|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.0001
71648646|NCT03480022|142814859|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71648647|NCT03480022|142814860|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71648648|NCT03480022|142814861|SUPERIORITY||||||<|0.021|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.021
71648649|NCT03480022|142814862|SUPERIORITY||||||<|0.009|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.009
71648650|NCT03480022|142814863|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.035
71648651|NCT03480022|142814864|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
71648652|NCT03480022|142814865|SUPERIORITY||||||<|0.042|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.042
71648653|NCT03480022|142814866|SUPERIORITY||||||<|0.033|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.033
71648654|NCT03480022|142814867|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71648655|NCT03480022|142814868|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71648656|NCT03480022|142814869|SUPERIORITY||||||<|0.016|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.016
71648657|NCT03480022|142814870|SUPERIORITY||||||<|0.028|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.028
71648658|NCT03480022|142814871|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||<0.01
71648659|NCT03480022|142814872|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71648660|NCT03480022|142814873|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated measures general linear model (SS/drug treatments by visits) where arm of drug therapy as between subjects effect and visit (baseline and 32 weeks of treatment) as within subject effect||||>0.05
71648661|NCT03174158|142814875|SUPERIORITY|||||||0.07||||||a priori p value threshold \< 0.05|Chi-squared|||||||0.07
71648662|NCT03174158|142814875|SUPERIORITY|||||||0.18|||||||Chi-squared|a priori threshold p\<0.05||||||0.18
71648663|NCT03174158|142814875|SUPERIORITY|||||||0.21||||||a priori threshold p\<0.05|Chi-squared|||||||0.21
71648664|NCT00283842|142814884|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.084
71648665|NCT00283842|142814884|SUPERIORITY_OR_OTHER|||||||0.084|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.084
71648666|NCT00283842|142814884|SUPERIORITY_OR_OTHER|||||||0.001|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.001
71648667|NCT00283842|142814884|SUPERIORITY_OR_OTHER|||||||0.027|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.027
71648668|NCT00283842|142814885|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 50mg.||||0.375
71648669|NCT00283842|142814885|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 100mg.||||0.342
71648670|NCT00283842|142814885|SUPERIORITY_OR_OTHER|||||||0.342|||||||Hochberg|||Statistical analysis provided for 200mg.||||0.342
71648671|NCT00283842|142814885|SUPERIORITY_OR_OTHER|||||||0.375|||||||Hochberg|||Statistical analysis provided for 400mg.||||0.375
71648672|NCT05068661|142814891|SUPERIORITY||Risk Ratio (RR)|0.75||||0.486|TWO_SIDED|95.0|0.4|1.39|||Chi-squared|||||1.39|0.40|0.486
71648673|NCT05068661|142814892|SUPERIORITY||Risk Ratio (RR)|0.85||||0.148|TWO_SIDED|95.0|0.69|1.06||This is adjusted P value for hypotension|Chi-squared|||||1.06|0.69|0.148
71648674|NCT05068661|142814893|SUPERIORITY||Risk Ratio (RR)|1.04|||>|0.999|TWO_SIDED|95.0|0.98|1.1||This is adjusted P value|Chi-squared|||||1.10|0.98|>0.999
71648675|NCT05068661|142814894|SUPERIORITY||Mean Ratio|1.9||||0.128|TWO_SIDED|95.0|1.14|3.18||Adjusted P value|Regression, Linear|||||3.18|1.14|0.128
71648676|NCT05068661|142814895|SUPERIORITY||Mean Ratio|1.04|||>|0.999|TWO_SIDED|95.0|0.8|1.35||Adjusted P value|Regression, Linear|||||1.35|0.80|>0.999
71648677|NCT05068661|142814896|SUPERIORITY||Mean Ratio|0.97|||>|0.999|TWO_SIDED|95.0|0.93|1.3||Adjusted P value|Regression, Linear|||||1.30|0.93|>0.999
71648678|NCT05068661|142814897|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.999|TWO_SIDED|95.0|0.52|1.25||Adjusted P value|Chi-squared|||||1.25|0.52|>0.999
71648679|NCT05068661|142814898|SUPERIORITY||Risk Ratio (RR)|0.85|||>|0.999|TWO_SIDED|95.0|0.58|1.24||Adjusted P value|Chi-squared|||||1.24|0.58|>0.999
71648680|NCT05068661|142814899|SUPERIORITY||Mean Ratio|1.03|||>|0.999|TWO_SIDED|95.0|0.86|1.22||Adjusted P value|Regression, Linear|||||1.22|0.86|>0.999
71648681|NCT01321177|142814972|SUPERIORITY|||||||0.0145|||||||Regression, Linear|||||||0.0145
71648682|NCT03980522|142815004|OTHER||Inter-subject variance|19.1908|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and standard deviation (SD) from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648683|NCT03980522|142815004|OTHER||Inter-subject variance|0.0018|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648684|NCT03980522|142815004|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648685|NCT03980522|142815004|OTHER||Intra-subject variance|12.6852|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648686|NCT03980522|142815004|OTHER||Intra-subject variance|0.1842|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648687|NCT03980522|142815004|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648688|NCT03980522|142815005|OTHER||Inter-subject variance|34.1446|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648689|NCT03980522|142815005|OTHER||Inter-subject variance|0.1326|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648690|NCT03980522|142815005|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648691|NCT03980522|142815005|OTHER||Intra-subject variance|0.0548|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648692|NCT03980522|142815005|OTHER||Intra-subject variance|0.0134|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648693|NCT03980522|142815005|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of CRP levels for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in CRP level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648694|NCT03980522|142815006|OTHER||Inter-subject variance|2.8139|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648695|NCT03980522|142815006|OTHER||Inter-subject variance|6.9999|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648696|NCT03980522|142815006|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648697|NCT03980522|142815006|OTHER||Intra-subject variance|0.9693|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648698|NCT03980522|142815006|OTHER||Intra-subject variance|0.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648699|NCT03980522|142815006|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled pre-baseline visits was used."||||
71648700|NCT03980522|142815007|OTHER||Inter-subject variance|1.9968|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648701|NCT03980522|142815007|OTHER||Inter-subject variance|0.9047|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648702|NCT03980522|142815007|OTHER||Inter-subject variance|0.0|||||TWO_SIDED|||||||||"Inter-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of inter-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648703|NCT03980522|142815007|OTHER||Intra-subject variance|1.7598|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648704|NCT03980522|142815007|OTHER||Intra-subject variance|2.849|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648705|NCT03980522|142815007|OTHER||Intra-subject variance|1.0|||||TWO_SIDED|||||||||"Intra-subject variability of NRS Scores for Part 1, 2, and 4 participants was a designated primary endpoint.~Estimates of intra-subject variance and SD from a mixed model for repeated measures with change from baseline in NRS level as the outcome, repeated effect of visit and random effect of subject. Variance Components covariance structure was assumed. The data from all scheduled post-baseline visits was used."||||
71648706|NCT04892147|142815010|OTHER|"Mean value of Enjoyment (8-item summed scale) tested against the value of a Neutral Likert response (Neutral value = 3)."|||||<|0.001||||||The threshold for statistical significance was p = 0.05. The reported value is a calculated -p-value.|t-test, 2 sided|||||||<0.001
71648707|NCT04892147|142815011|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.259||||||The threshold for statistical significance was p = 0.05|Regression, Linear|||||||0.259
71648708|NCT04892147|142815012|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.711||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.711
71648709|NCT04892147|142815013|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.214||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.214
71648710|NCT04892147|142815014|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.317||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.317
71648711|NCT04892147|142815015|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.056||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.056
71648712|NCT04892147|142815016|EQUIVALENCE|Analyses were conducted using general linear models, controlling for baseline levels only with treatment group as the predictor of interest.||||||0.562||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||||||0.562
71648713|NCT02707276|142815022|SUPERIORITY||Mean Difference (Final Values)|-0.625|STANDARD_DEVIATION|12.0|<|0.76|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|mean raw change active-sham; pooled standard deviation|Repeated measures ANCOVA with baseline MADRS scores as covariate for treatment and order effects of difference in MADRS scores.||||<0.76
71648714|NCT02707276|142815022|SUPERIORITY||Mean Difference (Final Values)|-5.17|STANDARD_DEVIATION|4.96|<|0.33|TWO_SIDED||||||ANCOVA|Baseline covariate|Pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.33
71702457|NCT01482221|142921890|SUPERIORITY_OR_OTHER||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.133|TWO_SIDED|95.0|-0.42|3.12||Analysis for changed in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.||3.12|-0.42|0.133
71648715|NCT02707276|142815023|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|9.1|<|0.61|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw change active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline HARS scores as covariate for treatment and order effects of difference in HARS scores.||||<0.61
71648716|NCT02707276|142815023|SUPERIORITY||Mean Difference (Final Values)|-4.33|STANDARD_DEVIATION|4.0|<|0.32|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.32
71648717|NCT02707276|142815024|SUPERIORITY||Mean Difference (Final Values)|-1.625|STANDARD_DEVIATION|10.2|<|0.78|TWO_SIDED||||||ANCOVA|repeated measures ANCOVA|raw active-sham mean; pooled standard deviation|Repeated measures ANCOVA with baseline PANAS (Positive sub scale) scores as covariate for treatment and order effects of difference in PANAS (Positive sub scale) scores.||||<0.78
71648718|NCT02707276|142815024|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.42|<|0.99|TWO_SIDED||||||ANCOVA|baseline as covariate|pooled deviation|ANCOVA: Analysis of group differences in change scores with baseline as a covariate||||<0.99
71648719|NCT03702816|142815042|OTHER|Linear Regression||||||0.6|||||||Regression, Linear|F=0.308||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.60
71648720|NCT03702816|142815042|OTHER|Linear Regression||||||0.56|||||||Regression, Linear|F=0.367||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.56
71824330|NCT00783692|143152510|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.7||||0.2322|TWO_SIDED|95.0|-3.6|15.0||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.||15.0|-3.6|0.2322
71648721|NCT03702816|142815042|OTHER|Linear regression||||||0.44|||||||Regression, Linear|||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.44
71648722|NCT03702816|142815042|OTHER|Linear Regression||||||0.15|||||||Regression, Linear|F=2.55||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in Control Subjects||||0.15
71648723|NCT03702816|142815042|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=0.947||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.39
71648724|NCT03702816|142815042|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.004||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.95
71648725|NCT03702816|142815042|OTHER|Linear Regulation||||||0.53|||||||Regression, Linear|F=0.483||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.53
71762743|NCT02785770|143027146|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0734|TWO_SIDED|90.0|-3.97|-0.17|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.17|-3.97|0.0734
71648726|NCT03702816|142815042|OTHER|Linear Regression||||||0.19|||||||Regression, Linear|F=2.543||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in MCI Subjects||||0.19
71648727|NCT03702816|142815042|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=3.430||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.32
71648728|NCT03702816|142815042|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=32.844||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.11
71648729|NCT03702816|142815042|OTHER|Linear Regression||||||0.31|||||||Regression, Linear|F=3.559||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.31
71648730|NCT03702816|142815042|OTHER|Linear Regression||||||0.005|||||||Regression, Linear|F=14362.699||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in AD Subjects||||0.005
71648731|NCT03702816|142815042|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.056||Linear Regression of Memory Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.84
71648732|NCT03702816|142815042|OTHER|Linear Regression||||||0.94|||||||Regression, Linear|F=0.008||Linear Regression of Executive Function Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.94
71648733|NCT03702816|142815042|OTHER|Linear Regression||||||0.29|||||||Regression, Linear|F=2.01||Linear Regression of Speed Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.29
71648734|NCT03702816|142815042|OTHER|Linear Regression||||||0.72|||||||Regression, Linear|F=0.173||Linear Regression of Language Composite Scores and Frontal GE180 SUVR in PD Subjects||||0.72
71648735|NCT03702816|142815043|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.424||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.54
71648736|NCT03702816|142815043|OTHER|Linear Regression||||||0.53|||||||Regression, Linear|F=0.447||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.53
71648737|NCT03702816|142815043|OTHER|Linear Regression||||||0.23|||||||Regression, Linear|F=1.773||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.23
71648738|NCT03702816|142815043|OTHER|Linear Regression||||||0.01|||||||Regression, Linear|F=3.615||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in Control Subjects||||0.01
71648739|NCT03702816|142815043|OTHER|Linear Regression||||||0.039|||||||Regression, Linear|F=9.204||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.039
71648740|NCT03702816|142815043|OTHER|Linear Regression||||||0.33|||||||Regression, Linear|F=1.209||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.33
71648741|NCT03702816|142815043|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=5.801||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.07
71648742|NCT03702816|142815043|OTHER|Linear Regression||||||0.03|||||||Regression, Linear|F=10.374||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in MCI Subjects||||0.03
71648743|NCT03702816|142815043|OTHER|Linear Regression||||||0.27|||||||Regression, Linear|F=5.024||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.27
71648744|NCT03702816|142815043|OTHER|Linear Regression||||||0.16|||||||Regression, Linear|F=15.568||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.16
71648745|NCT03702816|142815043|OTHER|Linear Regression||||||0.262|||||||Regression, Linear|F=5.238||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.262
71648746|NCT03702816|142815043|OTHER|Linear Regression||||||0.043|||||||Regression, Linear|F=221.308||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in AD Subjects||||0.043
71648747|NCT03702816|142815043|OTHER|Linear Regression||||||0.26|||||||Regression, Linear|F=2.430||Linear Regression of Memory Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.26
71648748|NCT03702816|142815043|OTHER|Linear Regression||||||0.38|||||||Regression, Linear|F=1.269||Linear Regression of Executive Function Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.38
71648749|NCT03702816|142815043|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=13.164||Linear Regression of Speed Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.07
71648750|NCT03702816|142815043|OTHER|Linear Regression||||||0.37|||||||Regression, Linear|F=1.312||Linear Regression of Language Composite Scores and Cingulate GE180 SUVR in PD Subjects||||0.37
71648751|NCT03702816|142815044|OTHER|Linear Regression||||||0.64|||||||Regression, Linear|F=0.233||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.64
71648752|NCT03702816|142815044|OTHER|Linear Regression||||||0.92|||||||Regression, Linear|F=0.011||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.92
71648753|NCT03702816|142815044|OTHER|Linear Regression||||||0.22|||||||Regression, Linear|F=1.790||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.22
71648754|NCT03702816|142815044|OTHER|Linear Regression||||||0.42|||||||Regression, Linear|F=0.720||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in Control Subjects||||0.42
71648755|NCT03702816|142815044|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.305||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.61
71648756|NCT03702816|142815044|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.95
71648757|NCT03702816|142815044|OTHER|Linear Regression||||||0.55|||||||Regression, Linear|F=0.435||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.55
71648758|NCT03702816|142815044|OTHER|Linear Regression||||||0.43|||||||Regression, Linear|F=0.787||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in MCI Subjects||||0.43
71648759|NCT03702816|142815044|OTHER|Linear Regression||||||0.036|||||||Regression, Linear|F=316.379||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.036
71648760|NCT03702816|142815044|OTHER|Linear Regression||||||0.39|||||||Regression, Linear|F=2.032||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.39
71648761|NCT03702816|142815044|OTHER|Linear Regression||||||0.031|||||||Regression, Linear|F=425.337||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.031
71648762|NCT03702816|142815044|OTHER|Linear Regression||||||0.274|||||||Regression, Linear|F=4.739||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in AD Subjects||||0.274
71648763|NCT03702816|142815044|OTHER|Linear Regression||||||0.66|||||||Regression, Linear|F=0.263||Linear Regression of Memory Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.66
71648764|NCT03702816|142815044|OTHER|Linear Regression||||||0.07|||||||Regression, Linear|F=12.244||Linear Regression of Executive Function Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.07
71648765|NCT03702816|142815044|OTHER|Linear Regression||||||0.48|||||||Regression, Linear|F=0.762||Linear Regression of Speed Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.48
71648766|NCT03702816|142815044|OTHER|Linear Regression||||||0.12|||||||Regression, Linear|F=7.107||Linear Regression of Language Composite Scores and Parietal GE180 SUVR in PD Subjects||||0.12
71648767|NCT03702816|142815045|OTHER|Linear Regression||||||0.85|||||||Regression, Linear|F=0.038||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.85
71648768|NCT03702816|142815045|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.042||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.84
71648769|NCT03702816|142815045|OTHER|Linear Regression||||||0.35|||||||Regression, Linear|F=1.021||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.35
71648770|NCT03702816|142815045|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.610||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in Control Subjects||||0.25
71648771|NCT03702816|142815045|OTHER|Linear Regression||||||0.25|||||||Regression, Linear|F=1.779||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.25
71648772|NCT03702816|142815045|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.455||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.54
71648773|NCT03702816|142815045|OTHER|Linear Regression||||||0.47|||||||Regression, Linear|F=0.650||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.47
71648774|NCT03702816|142815045|OTHER|Linear Regression||||||0.74|||||||Regression, Linear|F=0.131||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in MCI Subjects||||0.74
71648775|NCT03702816|142815045|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.075||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
71648776|NCT03702816|142815045|OTHER|Linear Regression||||||0.41|||||||Regression, Linear|F=1.831||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.41
71648777|NCT03702816|142815045|OTHER|Linear Regression||||||0.83|||||||Regression, Linear|F=0.079||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.83
71648778|NCT03702816|142815045|OTHER|Linear Regression||||||0.52|||||||Regression, Linear|F=0.879||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in AD Subjects||||0.52
71648779|NCT03702816|142815045|OTHER|Linear Regression||||||0.98|||||||Regression, Linear|F=0.001||Linear Regression of Memory Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.98
71824331|NCT00783692|143152511|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.5||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||27.5|7.3|0.0007
71648780|NCT03702816|142815045|OTHER|Linear Regression||||||0.95|||||||Regression, Linear|F=0.005||Linear Regression of Executive Function Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.95
71648781|NCT03702816|142815045|OTHER|Linear Regression||||||0.32|||||||Regression, Linear|F=1.733||Linear Regression of Speed Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.32
71648782|NCT03702816|142815045|OTHER|Linear Regression||||||0.67|||||||Regression, Linear|F=0.249||Linear Regression of Language Composite Scores and Temporal GE180 SUVR in PD Subjects||||0.67
71648783|NCT03702816|142815046|OTHER|Linear Regression||||||0.76|||||||Regression, Linear|F=0.098||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in Control Subjects||||0.76
71648784|NCT03702816|142815046|OTHER|Linear Regression||||||0.49|||||||Regression, Linear|F=0.513||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in Control Subjects||||0.49
71648785|NCT03702816|142815046|OTHER|Linear Regression||||||0.93|||||||Regression, Linear|F=0.008||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.93
71648786|NCT03702816|142815046|OTHER|Linear Regression||||||0.54|||||||Regression, Linear|F=0.430||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in MCI Subjects||||0.54
71648787|NCT03702816|142815046|OTHER|Linear Regression||||||0.77|||||||Regression, Linear|F=0.142||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in AD Subjects||||0.77
71648788|NCT03702816|142815046|OTHER|Linear Regression||||||0.61|||||||Regression, Linear|F=0.496||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in AD Subjects||||0.61
71648789|NCT03702816|142815046|OTHER|Linear Regression||||||0.11|||||||Regression, Linear|F=8.046||Linear Regression of DRS Scores and Whole Brain GE180 SUVR in PD Subjects||||0.11
71648790|NCT03702816|142815046|OTHER|Linear Regression||||||0.84|||||||Regression, Linear|F=0.051||Linear Regression of MoCA Scores and Whole Brain GE180 SUVR in PD Subjects||||0.84
71648791|NCT00360490|142815094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
71648792|NCT00360490|142815095|SUPERIORITY_OR_OTHER||Risk Difference (RD)|62.59|||<|0.001||95.0|50.56|74.61|||Chi-squared|||The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.||74.61|50.56|<0.001
71648793|NCT00360490|142815096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.2|||<|0.001||95.0|-70.2|-28.3|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.||-28.3|-70.2|<0.001
71648794|NCT00360490|142815097|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||||<0.001
71648795|NCT00360490|142815098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001||95.0|-63.8|-37.4|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.||-37.4|-63.8|<0.001
71648796|NCT00360490|142815108|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.06||||||95.0|14.75|37.36||||||A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6||37.36|14.75|
71648797|NCT04640194|142815131|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.39|2.61|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||2.61|0.39|
71648798|NCT04640194|142815131|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.27|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||3.27|0.46|
71648799|NCT04640194|142815131|OTHER||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.73|4.15|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||4.15|0.73|
71648800|NCT04640194|142815131|OTHER||Hazard Ratio (HR)|2.04|||||TWO_SIDED|95.0|0.83|5.01|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||5.01|0.83|
71648801|NCT04640194|142815131|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.35|3.66|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Unadjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment. The confidence intervals was determined using the Wald method to determine the variance.||3.66|0.35|
71648802|NCT04640194|142815131|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.33|4.22|||||A hazard ratio \> 1 favours the alteplase dose group over standard of care alone.|Adjusted Hazard Ratio: Cox proportional hazard model containing fixed effect for treatment,ventilation status at baseline and age. The confidence intervals was determined using the Wald method to determine the variance.||4.22|0.33|
71648803|NCT04640194|142815132|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-10.892|24.8734|||||Chan and Zhang exact confidence interval.|||24.8734|-10.892|
71648804|NCT04640194|142815132|OTHER||Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|2.3075|43.6615|||||Chan and Zhang exact confidence interval.|||43.6615|2.3075|
71648805|NCT04640194|142815132|OTHER||Risk Difference (RD)|11.76|||||TWO_SIDED|95.0|-24.127|36.9012|||||Chan and Zhang exact confidence interval.|||36.9012|-24.127|
71648806|NCT04640194|142815133|OTHER||Risk Difference (RD)|-16.6|||||TWO_SIDED|95.0|-38.6|5.5|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||5.5|-38.6|
71648807|NCT04640194|142815133|OTHER||Risk Difference (RD)|-11.8|||||TWO_SIDED|95.0|-35.1|11.6|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||11.6|-35.1|
71648808|NCT04640194|142815133|OTHER||Risk Difference (RD)|-19.1||||0.2419|TWO_SIDED|95.0|-51.1|12.9|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Unadjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for treatment.||12.9|-51.1|0.2419
71648809|NCT04640194|142815134|OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-37.1|19.1|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.1|-37.1|
71648810|NCT04640194|142815134|OTHER||Risk Difference (RD)|-9.1|||||TWO_SIDED|95.0|-37.2|19.0|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.0|-37.2|
71648811|NCT04640194|142815134|OTHER||Risk Difference (RD)|14.5||||0.2523|TWO_SIDED|95.0|-10.3|39.3|||The delta method and average marginal.||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% CI is based upon average marginal effect Delta method, adjusting for baseline D-dimer status, age, days of NIV support and treatment.||39.3|-10.3|0.2523
71648812|NCT04640194|142815135|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-4.4|10.6|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||10.6|-4.4|
71648813|NCT04640194|142815135|OTHER||Median Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-3.2|11.8|||||Calculated as alteplase dose group - standard of care alone.|Parameters included in model: treatment,ventilation status at baseline, and age.||11.8|-3.2|
71648814|NCT04640194|142815136|OTHER||Risk Difference (RD)|-4.9|||||TWO_SIDED|95.0|-29.0|19.2|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||19.2|-29.0|
71648815|NCT04640194|142815136|OTHER||Risk Difference (RD)|-15.2|||||TWO_SIDED|95.0|-36.8|6.3|||||Calculated as alteplase dose group - standard of care alone.|Adjusted risk difference and 95% confidence interval is based upon average marginal effect Delta method, adjusting for baseline ventilation status, age and treatment.||6.3|-36.8|
71648816|NCT04640194|142815137|OTHER||Median Difference (Net)|17.193|||||TWO_SIDED|95.0|-28.45|52.33|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||52.33|-28.45|
71648817|NCT04640194|142815137|OTHER||Median Difference (Final Values)|54.436|||||TWO_SIDED|95.0|0.49|110.36|||||Calculated as alteplase dose group - standard of care alone.|Based upon Hedges-Lehmann estimator handling deaths as failure and Wilcoxon rank sum test methodology.||110.36|0.49|
71648818|NCT04640194|142815139|OTHER||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|3.6||0.9856|TWO_SIDED|95.0|-7.5|7.6|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||7.6|-7.5|0.9856
71648819|NCT04640194|142815139|OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|3.8||0.8729|TWO_SIDED|95.0|-8.5|7.3|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level and age.||7.3|-8.5|0.8729
71648820|NCT04640194|142815140|OTHER||Mean Difference (Net)|70.9|STANDARD_ERROR_OF_MEAN|35.8||0.0603|TWO_SIDED|95.0|-3.3|145.1|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Unadjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment.||145.1|-3.3|0.0603
71648821|NCT04640194|142815140|OTHER||Mean Difference (Final Values)|87.2|STANDARD_ERROR_OF_MEAN|38.5||0.0362|TWO_SIDED|95.0|6.3|168.0|||ANCOVA||Calculated as alteplase dose group - standard of care alone.|Adjusted mean difference: A restricted maximum likelihood (REML) based Analysis of Covariance (ANCOVA) was used. Adjustment was made for treatment, the number of days under NIV support, baseline D-Dimer level, baseline PaO2/FiO2 ratio and age.||168.0|6.3|0.0362
71648822|NCT04773600|142815161|SUPERIORITY||Odds Ratio (OR)|3.19|||<|0.0001|TWO_SIDED|95.0|1.962|5.183|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA Success at Week 4||5.183|1.962|<0.0001
71648823|NCT04773600|142815162|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.0001|TWO_SIDED|95.0|1.996|5.687|||Cochran-Mantel-Haenszel|Stratified by pooled study site|Stratified by pooled study site|vIGA Success at Week 4 in Participants with Baseline vIGA = 'Moderate'||5.687|1.996|<0.0001
71648824|NCT04773600|142815163|SUPERIORITY||Odds Ratio (OR)|4.42|||<|0.0001|TWO_SIDED|95.0|2.281|8.658|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 2||8.658|2.281|<0.0001
71648825|NCT04773600|142815164|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1156|TWO_SIDED|95.0|0.832|4.782|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Success at Week 1||4.782|0.832|0.1156
71648826|NCT04773600|142815165|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0014|TWO_SIDED|95.0|1.448|5.066|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 4||5.066|1.448|0.0014
71648827|NCT04773600|142815166|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0015|TWO_SIDED|95.0|1.591|7.927|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 2||7.927|1.591|0.0015
71648828|NCT04773600|142815167|SUPERIORITY||Odds Ratio (OR)|7.84||||0.002|TWO_SIDED|95.0|1.717|35.764|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|≥4-Point Reduction in WI-NRS at Week 1||35.764|1.717|0.0020
71648829|NCT04773600|142815168|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.108|4.964|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|EASI-75 at Week 4||4.964|2.108|<0.0001
71648830|NCT04773600|142815169|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.191|5.24|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||5.240|2.191|<0.0001
71648831|NCT04773600|142815170|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.097|5.854|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.854|2.097|<0.0001
71648832|NCT04773600|142815171|SUPERIORITY||Odds Ratio (OR)|2.56||||0.005|TWO_SIDED|95.0|1.312|4.993|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata|Stratified by pooled study site and vIGA-AD randomization strata|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||4.993|1.312|0.0050
71648833|NCT00500318|142815176|SUPERIORITY_OR_OTHER||Least Square Mean|116.44|STANDARD_ERROR_OF_MEAN|40.113||0.0042|TWO_SIDED|95.0|37.28|195.61|||ANCOVA|||||195.610|37.280|0.0042
71648834|NCT02104817|142815225|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.837|TWO_SIDED|95.0|0.9|1.09||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.09|0.90|0.837
71648835|NCT02104817|142815226|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.269|TWO_SIDED|95.0|0.84|1.05||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.05|0.84|0.269
71648836|NCT02104817|142815227|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.93|1.19||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.19|0.93|0.402
71648837|NCT02104817|142815228|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.16||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.16|0.87|0.940
71648838|NCT02104817|142815229|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.092|TWO_SIDED|95.0|0.81|1.02||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.02|0.81|0.092
71648839|NCT02104817|142815230|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.016|TWO_SIDED|95.0|0.75|0.97||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||0.97|0.75|0.016
71648840|NCT02104817|142815231|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.372|TWO_SIDED|95.0|0.9|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing|Regression, Cox|||||1.31|0.90|0.372
71648841|NCT02104817|142815232|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.336|TWO_SIDED|95.0|0.89|1.41||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.41|0.89|0.336
71762744|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|0.8||||0.2588|TWO_SIDED|90.0|-0.36|1.96|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.96|-0.36|0.2588
71648842|NCT02104817|142815233|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.112|TWO_SIDED|95.0|0.97|1.31||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.31|0.97|0.112
71648843|NCT02104817|142815234|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.091|TWO_SIDED|95.0|0.97|1.42||The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.|Regression, Cox|||||1.42|0.97|0.091
71648844|NCT02104817|142815235|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.408|TWO_SIDED|95.0|0.83|1.08||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.08|0.83|0.408
71648845|NCT02104817|142815236|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.233|TWO_SIDED|95.0|0.63|1.12||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.12|0.63|0.233
71648846|NCT02104817|142815237|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.81|1.17||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.17|0.81|0.770
71648847|NCT02104817|142815238|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.278|TWO_SIDED|95.0|0.9|1.45||This endpoint was not in the testing sequence and therefore not under type I error control.|Regression, Cox|||||1.45|0.90|0.278
71648848|NCT01225055|142815239|SUPERIORITY|||||||0.84||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.84
71648849|NCT01225055|142815239|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.64
71648850|NCT01225055|142815239|SUPERIORITY|||||||0.26||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.26
71648851|NCT01225055|142815240|SUPERIORITY|||||||0.64||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.64
71648852|NCT01225055|142815240|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.00
71648853|NCT01225055|142815240|SUPERIORITY|||||||0.09||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.09
71648854|NCT01225055|142815241|SUPERIORITY|||||||0.72||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.72
71648855|NCT01225055|142815241|SUPERIORITY|||||||0.58||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.58
71648856|NCT01225055|142815241|SUPERIORITY|||||||0.44||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.44
71648857|NCT01225055|142815242|SUPERIORITY|||||||0.02||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.02
71648858|NCT01225055|142815242|SUPERIORITY|||||||0.1||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.10
71648859|NCT01225055|142815242|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
71648860|NCT01225055|142815243|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.01
71648861|NCT01225055|142815243|SUPERIORITY|||||||0.34||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.34
71648862|NCT01225055|142815243|SUPERIORITY|||||||0.2||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.20
71648863|NCT01225055|142815244|SUPERIORITY|||||||0||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA||||||0.00
71648864|NCT01225055|142815244|SUPERIORITY|||||||0.01||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA||||||0.01
71648865|NCT01225055|142815244|SUPERIORITY|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA||||||0.04
71648866|NCT04633642|142815257|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_DEVIATION|0.74|<|0.01|TWO_SIDED|||||The threshold for statistical significances was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71648867|NCT04633642|142815258|SUPERIORITY||Mean Difference (Final Values)|1.61|STANDARD_DEVIATION|0.17|<|0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71648868|NCT04633642|142815259|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.79|<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71702458|NCT03086343|142921891|NON_INFERIORITY|The non-inferiority of upadacitinib 15 mg versus abatacept was tested using the 95% confidence interval (CI) of treatment difference against a non-inferiority margin of 0.6.|LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates.|ANCOVA||Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
71648869|NCT04633642|142815260|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_DEVIATION|0.44||0.01|TWO_SIDED|||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical di↵erence of 37% to detect a statistically significant between groups.||||0.01
71648870|NCT04633642|142815261|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.93|TWO_SIDED|||||The threshold for statistics significance was p\<0.05|t-test, 2 sided|||||||0.93
71648871|NCT04633642|142815262|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.711|TWO_SIDED||||||t-test, 2 sided|||We analyzed 51 patients (24 in surgical group and 27 in UAW group) with a statistical power of 0.80 and an alpha of 0.05, with a power of the clinical difference of 37% to detect a statistically significant between groups.||||0.711
71648872|NCT03223909|142815289|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of groups in the baseline visit versus final visit"||||||0.08|||||||ANOVA|||||||0.080
71648873|NCT03223909|142815289|NON_INFERIORITY|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis between groups in the final visit"||||||0.848|||||||ANOVA|||||||0.848
71648874|NCT03223909|142815290|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.468|||||||Chi-squared, Corrected|||||||0.468
71648875|NCT03223909|142815291|NON_INFERIORITY|population analysis was per protocol||||||0.0001|||||||ANOVA|||||||0.0001
71648876|NCT03223909|142815291|NON_INFERIORITY|population analysis was per protocol||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.650
71648877|NCT03223909|142815292|NON_INFERIORITY|"It was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit."||||||0.003|||||||ANOVA|||||||0.003
71648878|NCT03223909|142815292|NON_INFERIORITY|It was considered as not inferior when the treatments did not present differences greater than 20% Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit.||||||0.003|||||||ANOVA|||||||0.003
71648879|NCT03223909|142815293|NON_INFERIORITY|"the statistical analysis was carried out by intention to treat~It was considered as not inferior when the treatments did not present differences greater than 20%"||||||0.93|||||||Chi-squared|||||||0.930
71648880|NCT03223909|142815294|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.548|||||||ANOVA|||||||0.548
71648881|NCT03223909|142815295|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.17|||||||ANOVA|||||||0.170
71648882|NCT03223909|142815296|NON_INFERIORITY|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.085|||||||Chi-squared, Corrected|||||||0.085
71648883|NCT01628549|142815300|SUPERIORITY||Difference in Least Squares Means|1.53||||0.4344|TWO_SIDED|95.0|-2.32|5.38|||ANCOVA|||||5.38|-2.32|0.4344
71648884|NCT01628549|142815300|SUPERIORITY||Difference in Least Squares Means|4.46||||0.0266|TWO_SIDED|95.0|0.52|8.4|||ANCOVA|||||8.40|0.52|0.0266
71648885|NCT01628549|142815300|SUPERIORITY||Difference in Least Squares Means|4.37||||0.0317|TWO_SIDED|95.0|0.39|8.36|||ANCOVA|||||8.36|0.39|0.0317
71648886|NCT01628549|142815301|SUPERIORITY||Difference vs placebo in success rate|3.4||||0.33|TWO_SIDED|95.0|-7.82|14.38|||Cochran-Mantel-Haenszel|||||14.38|-7.82|0.3300
71648887|NCT01628549|142815301|SUPERIORITY||Difference vs placebo in success rate|13.2||||0.0159|TWO_SIDED|95.0|0.54|25.6|||Cochran-Mantel-Haenszel|||||25.60|0.54|0.0159
71648888|NCT01628549|142815301|SUPERIORITY||Difference vs placebo in success rate|4.1||||0.4834|TWO_SIDED|95.0|-7.44|15.87|||Cochran-Mantel-Haenszel|||||15.87|-7.44|0.4834
71648889|NCT01405469|142815309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.44|STANDARD_DEVIATION|2.66|<|0.001||95.0|||||t-test, 2 sided|||this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ' s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.||||<0.001
71648890|NCT00974350|142815355|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.353||0.0031|TWO_SIDED|95.0|-1.84|-0.44|||ANOVA|LS Mean difference from SABER-Placebo||Pain Intensity on Movement AUCs1-72 hours Including Pain Assessed Upon Taking Opioid Rescue - ITT||-0.44|-1.84|0.0031
71648891|NCT00974350|142815356|SUPERIORITY|||||||0.0909|||||||Cochran-Mantel-Haenszel|Stratified by pooled study sites||Proportion of Patients Not Taking Any Supplemental Opioid Analgesic Medication||||0.0909
71648892|NCT01344018|142815361|SUPERIORITY|"Time assessment biases were taken into account for the primary endpoint:~* Surgery alone arm: abdominal recurrence occurring prior to week 14 assessment was counted as occurring at week 14; progression occurring after the week 14 was counted as occurring at week 24.~* Preoperative RT arm: abdominal recurrence occurring was counted as occurring at week 14; and any abdominal recurrence occurring after and prior to or during the week 24 will be counted as occurring at week 24."|Hazard Ratio (HR)|1.01||||0.955|TWO_SIDED|95.0|0.71|1.44||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|The time assessment biases correction described before was not applied to patients for whom death was the first event.|The arm having surgery alone was the reference arm.|Sample size was determined to provide 90% power for detecting a Hazard Ratio (HR)=0.52 (which corresponds to a 20% difference in ARFS rate at 5 years, from 50% in the surgery arm to 70% in the experimental arm) at a global 2-sided 5% significance level assuming ARFS followed an exponential distribution in both arms. This test required 102 events at the time of the statistical analysis.||1.44|0.71|0.955
71648893|NCT01344018|142815366|SUPERIORITY|ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.|Hazard Ratio (HR)|1.09||||0.658|TWO_SIDED|95.0|0.74|1.6||A 5% significance level was considered as a threshold for statistical significance.|Fine and Gray model|||||1.60|0.74|0.658
71648894|NCT01344018|142815367|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.595|TWO_SIDED|95.0|0.58|1.36||A 5% significance level was considered as a threshold for statistical significance.|Regression, Cox|||||1.36|0.58|0.595
71648895|NCT01344018|142815368|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.615|TWO_SIDED|95.0|0.65|2.05|||Regression, Cox|||||2.05|0.65|0.615
71648896|NCT05070754|142815369|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
71648897|NCT05070754|142815370|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
71648898|NCT05070754|142815371|SUPERIORITY|||||||0.534|||||||Chi-squared|||Outcome measures 1-3 were all tested together. Null hypothesis was that there was no difference in the degree of lesion resolution between the two treatment methods.||||0.534
71648899|NCT05070754|142815372|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71824332|NCT00783692|143152511|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.7||||0.0042|TWO_SIDED|95.0|4.6|24.7||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was \> 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.||24.7|4.6|0.0042
71648900|NCT05070754|142815373|SUPERIORITY|||||||0.142|||||||Wilcoxon Signed Rank Test|||Null hypothesis: there was no difference in median pain levels between SOC and NTAP treated lesions.||||0.142
71648901|NCT01742208|142815395|SUPERIORITY||LS Mean Difference|-25.14||||0.007|TWO_SIDED|95.0|-42.78|-7.49||Threshold for significance at 0.05 level.|ANCOVA||Difference is sotagliflozin - placebo|Between-group comparison of the 2 Expansion Groups was based on an ANCOVA model with covariates of baseline mean total daily bolus insulin, treatment group, factor used to stratify the randomization (screening A1C \<= 8%, \> 8%), and random effect of participant\*treatment group.||-7.49|-42.78|0.007
71648902|NCT00715676|142815402|SUPERIORITY_OR_OTHER|||||||0.641||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.641
71648903|NCT00715676|142815402|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance||||0.243
71648904|NCT00715676|142815403|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||ANOVA|||||||0.778
71648905|NCT00715676|142815403|SUPERIORITY_OR_OTHER|||||||0.173||95.0|||||ANOVA|||||||0.173
71648906|NCT00715676|142815404|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||ANOVA|||||||0.395
71648907|NCT00715676|142815404|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||ANOVA|||||||0.523
71648908|NCT00715676|142815405|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||ANOVA|||||||0.928
71648909|NCT00715676|142815405|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||ANOVA|||||||0.124
71648910|NCT00715676|142815406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173||||||90.0|0.164|0.181||||||||0.181|0.164|
71648911|NCT00715676|142815406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.582||||||90.0|0.573|0.591||||||||0.591|0.573|
71824333|NCT00783692|143152512|SUPERIORITY_OR_OTHER|||||||0.9288||||||Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).|Wilcoxon (Mann-Whitney)|||If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.||||0.9288
71648912|NCT00372996|142815409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.56|TWO_SIDED|80.0|0.744|1.118|||Log Rank|2-sided p-value from an unstratified log-rank text|Hazard ratio was based on Cox proportional hazards model.|||1.118|0.744|0.560
71648913|NCT00372996|142815410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.331|TWO_SIDED|70.0|0.572|1.02||2-sided p-value from unstratified log-rank test|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||1.020|0.572|0.331
71648914|NCT00372996|142815411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.79||||0.463|TWO_SIDED|95.0|-8.0|17.6|||Pearson chi-square test|||||17.6|-8.0|0.463
71648915|NCT01091363|142815420|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.01|TWO_SIDED|95.0|1.67|12.99|||Regression, Logistic|||||12.99|1.67|<0.01
71648916|NCT01091363|142815421|SUPERIORITY_OR_OTHER|Hayes' PROCESS computation tool for a serial multiple mediator model predicting a binary logistic outcome.|Mean Difference (Net)|1.92||||0.02|TWO_SIDED|95.0|0.34|6.32|||Mediation Analysis|||Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes' PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).||6.32|0.34|0.02
71648917|NCT02151149|142815426|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9258|TWO_SIDED|95.0|0.84|1.21|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.21|0.84|0.9258
71648918|NCT02151149|142815433|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0036|TWO_SIDED|95.0|0.33|0.81|||Stratified Log Rank|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||0.81|0.33|0.0036
71648919|NCT02151149|142815434|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3537|TWO_SIDED|95.0|0.54|1.25|||Stratified log-rank test|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).||||1.25|0.54|0.3537
71648920|NCT02151149|142815435|SUPERIORITY||Risk Ratio (RR)|1.56||||0.0597|TWO_SIDED|95.0|0.971|2.511|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma)..||||2.511|0.971|0.0597
71648921|NCT02760433|142815436|SUPERIORITY||Risk Difference (RD)|0.19||||0.004|TWO_SIDED|97.5|0.03|0.337|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population. The OKZ ACR20 response rate for 64 mg q4w treatment group at Week 12 are expected to be at least 45%, resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.337|0.030|0.004
71648922|NCT02760433|142815436|SUPERIORITY||Risk Difference (RD)|0.203||||0.0029|TWO_SIDED|97.5|0.038|0.353|||Chi-squared|2x2 chi-square test||The ACR20 response rate at Week 12 for the placebo group is estimated to be 20% in this study population .The OKZ ACR20 response rate for 64 mg q2w treatment group at Week 12 is expected to be at least 50%, resulting in an expected difference in ACR20 response rates of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.353|0.038|0.0029
71648923|NCT02760433|142815437|SUPERIORITY||Risk Difference (RD)|0.176||||0.0021|TWO_SIDED|97.5|0.041|0.281|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.281|0.041|0.0021
71648924|NCT02760433|142815437|SUPERIORITY||Risk Difference (RD)|0.283|||<|0.0001|TWO_SIDED|97.5|0.139|0.396|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 was estimated to be 5% in the placebo group and 18% and 21% in 64 mg q4w and q2w OKZ groups, respectively, resulting in an expected difference of 13 and 16 percentage points between respective OKZ groups and placebo.||0.396|0.139|<0.0001
71648925|NCT02760433|142815438|SUPERIORITY||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.081|=|0.1814|TWO_SIDED|97.5|-0.26|0.11||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.11|-0.26|=0.1814
71648926|NCT02760433|142815438|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.083|=|0.0227|TWO_SIDED|97.5|-0.35|0.02||p-value was greater than the threshold p-value of 0.0125|ANCOVA|||||0.02|-0.35|=0.0227
71648927|NCT02760433|142815439|SUPERIORITY||Risk Difference (RD)|0.164|||||TWO_SIDED|97.5|0.02|0.278||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.278|0.020|
71648928|NCT02760433|142815439|SUPERIORITY||Risk Difference (RD)|0.174|||||TWO_SIDED|97.5|0.027|0.294||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made||||||0.294|0.027|
71648929|NCT02760433|142815440|SUPERIORITY||Risk Difference (RD)|0.031|||||TWO_SIDED|97.5|-0.052|0.083||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.083|-0.052|
71648930|NCT02760433|142815440|SUPERIORITY||Risk Difference (RD)|0.065|||||TWO_SIDED|97.5|-0.023|0.134||Due to the hierarchical nature of pre-planned statistical testing (gate-keeping strategy) a formal statement could not be made|||means continuity correction applied because expected cell counts \< 5|||0.134|-0.023|
71648931|NCT00216060|142815442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.08||||0.3|TWO_SIDED|95.0|0.51|8.4|||Regression, Cox|||||8.40|0.51|0.3
71648932|NCT00216060|142815443|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||univariate analysis|||||||0.12
71648933|NCT00216060|142815445|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71648934|NCT00216060|142815447|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71648935|NCT00216060|142815448|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Kruskal-Wallis|||||||0.010
71824334|NCT00783692|143152513|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.0132|TWO_SIDED|95.0|2.8|24.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||24.0|2.8|0.0132
71648936|NCT00216060|142815449|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71648937|NCT02058160|142815464|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.633|-0.397||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.||-0.397|-0.633|<0.0001
71648938|NCT02058160|142815465|SUPERIORITY_OR_OTHER||Difference in percentage|25.52|||<|0.0001|TWO_SIDED|95.0|18.94|32.1||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||32.10|18.94|<0.0001
71648939|NCT02058160|142815465|SUPERIORITY_OR_OTHER||Difference in percentage|19.76|||<|0.0001|TWO_SIDED|95.0|13.9|25.62|||Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."||25.62|13.90|<0.0001
71648940|NCT02058160|142815466|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-3.925|-2.939||Threshold for significance at 0.05 level.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.||-2.939|-3.925|<0.0001
71648941|NCT02058160|142815467|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-1.808|-0.93||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.||-0.93|-1.808|<0.0001
71648942|NCT02058160|142815468|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.154|-0.64||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.||-0.64|-1.154|<0.0001
71648943|NCT02058160|142815469|SUPERIORITY_OR_OTHER||difference in percentage|20.82|||<|0.0001|TWO_SIDED|95.0|14.98|26.66||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of metformin use at screening.||26.66|14.98|<0.0001
71648944|NCT02058160|142815470|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.766||0.7362|TWO_SIDED|95.0|-1.762|1.246||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.||1.246|-1.762|0.7362
71648945|NCT03538262|142815479|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
71648946|NCT03538262|142815479|OTHER|Statistical analysis for BL to Month 24|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71648947|NCT03538262|142815480|OTHER|||||||0.011|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.011
71648948|NCT03538262|142815480|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71648949|NCT03538262|142815481|OTHER|||||||0.007|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.007
71886424|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||5.05|1.85|<0.0001
71648950|NCT03538262|142815481|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
71648951|NCT03538262|142815481|OTHER|||||||0.004|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.004
71648952|NCT03538262|142815481|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
71648953|NCT03538262|142815481|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
71648954|NCT03538262|142815481|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
71648955|NCT03538262|142815481|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
71648956|NCT03538262|142815481|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71648957|NCT03538262|142815482|OTHER|||||||0.996|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.996
71648958|NCT03538262|142815482|OTHER|||||||0.054|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.054
71648959|NCT03538262|142815482|OTHER|||||||0.025|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.025
71648960|NCT03538262|142815482|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.006
71648961|NCT03538262|142815483|OTHER|||||||0.145|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.145
71648962|NCT03538262|142815483|OTHER|||||||0.029|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.029
71648963|NCT03538262|142815484|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<.001
71648964|NCT03538262|142815484|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71648965|NCT03538262|142815485|OTHER|||||||0.382|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.382
71886425|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||6.87|2.47|<0.0001
71648966|NCT03538262|142815485|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71648967|NCT03538262|142815486|OTHER|||||||0.688|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 12||||0.688
71648968|NCT03538262|142815486|OTHER|||||||0.293|||||||Mixed Models Analysis|||Secondary analysis for BL to Month 24||||0.293
71648969|NCT03538262|142815487|OTHER|||||||0.446|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.446
71648970|NCT03538262|142815487|OTHER|||||||0.565|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.565
71648971|NCT03538262|142815488|OTHER|||||||0.006|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.006
71648972|NCT03538262|142815488|OTHER|||||||0.937|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.937
71648973|NCT03538262|142815489|OTHER|||||||0.041|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.041
71648974|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
71648975|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
71648976|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
71648977|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
71648978|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
71648979|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
71648980|NCT03538262|142815489|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71648981|NCT03538262|142815490|OTHER|||||||0.595|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.595
71648982|NCT03538262|142815490|OTHER|||||||0.44|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.440
71648983|NCT03538262|142815490|OTHER|||||||0.909|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.909
71648984|NCT03538262|142815490|OTHER|||||||0.068|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.068
71648985|NCT03538262|142815491|OTHER|||||||0.074|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.074
71648986|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||<0.001
71648987|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||<0.001
71648988|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||<0.001
71648989|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||<0.001
71648990|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||<0.001
71648991|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||<0.001
71648992|NCT03538262|142815491|OTHER||||||<|0.001|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||<0.001
71648993|NCT03538262|142815492|OTHER|||||||0.2|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.200
71648994|NCT03538262|142815492|OTHER|||||||0.888|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 6||||0.888
71648995|NCT03538262|142815492|OTHER|||||||0.837|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.837
71648996|NCT03538262|142815492|OTHER|||||||0.394|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.394
71648997|NCT03538262|142815492|OTHER|||||||0.268|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.268
71648998|NCT03538262|142815492|OTHER|||||||0.039|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 18||||0.039
71648999|NCT03538262|142815492|OTHER|||||||0.979|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.979
71649000|NCT03538262|142815492|OTHER|||||||0.014|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 24||||0.014
71649001|NCT03538262|142815493|OTHER|||||||0.285|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 3||||0.285
71649002|NCT03538262|142815493|OTHER|||||||0.267|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 9||||0.267
71649003|NCT03538262|142815493|OTHER|||||||0.564|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 15||||0.564
71649004|NCT03538262|142815493|OTHER|||||||0.034|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 21||||0.034
71649005|NCT03538262|142815494|OTHER|||||||0.409|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 12||||0.409
71649006|NCT03538262|142815494|OTHER|||||||0.149|||||||Mixed Models Analysis|||Statistical analysis for BL to Month 0.149||||0.149
71649007|NCT02033317|142815497|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||paired t-test|||||||= 0.14
71649008|NCT02033317|142815498|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.02|TWO_SIDED||||||paired t-test|||||||= 0.02
71649009|NCT01160640|142815512|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value for proportion of women who had clearance of anaerobic organisms from the endometrium at the 30-day visit|Fisher Exact|||||||0.046
71649010|NCT01160640|142815514|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value for proportion of women who did not have M. genitalium detected in the cervix or endometrium at the 30-day visit|Fisher Exact|||||||0.16
71649011|NCT01160640|142815515|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value for proportion of women who experienced resolution of clinical signs and symptoms of PID at the 3-day visit|Fisher Exact|||||||0.74
71649012|NCT01525628|142815561|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|251.37|STANDARD_DEVIATION|31.0||1|TWO_SIDED|90.0|205.54|307.43|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||307.43|205.54|1.0000
71649013|NCT01525628|142815561|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|131.3|STANDARD_DEVIATION|32.5||0.6514|TWO_SIDED|90.0|105.4|163.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||163.57|105.40|0.6514
71649014|NCT01525628|142815562|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|381.11|STANDARD_DEVIATION|28.1||1|TWO_SIDED|90.0|317.01|458.19|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||458.19|317.01|1.0000
71649015|NCT01525628|142815562|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|123.65|STANDARD_DEVIATION|40.0||0.4718|TWO_SIDED|90.0|94.66|161.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.51|94.66|0.4718
71649016|NCT01525628|142815563|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|306.45|STANDARD_DEVIATION|30.7||1|TWO_SIDED|90.0|250.93|374.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||374.26|250.93|1.0000
71649017|NCT01525628|142815563|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|129.85|STANDARD_DEVIATION|32.5||0.6185|TWO_SIDED|90.0|104.26|161.71|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||161.71|104.26|0.6185
71649018|NCT01525628|142815564|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|286.01|STANDARD_DEVIATION|39.4||1|TWO_SIDED|90.0|228.51|357.97|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||357.97|228.51|1.0000
71649019|NCT01525628|142815564|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|150.45|STANDARD_DEVIATION|55.1||0.821|TWO_SIDED|90.0|106.81|211.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||211.91|106.81|0.8210
71649020|NCT01525628|142815565|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|349.9|STANDARD_DEVIATION|46.4||1|TWO_SIDED|90.0|269.12|454.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||454.93|269.12|1.0000
71649021|NCT01525628|142815565|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|176.56|STANDARD_DEVIATION|50.1||0.9533|TWO_SIDED|90.0|125.95|247.5|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||247.50|125.95|0.9533
71824335|NCT00783692|143152513|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.3||||0.0053|TWO_SIDED|95.0|4.6|26.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||26.0|4.6|0.0053
71649022|NCT01525628|142815566|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|322.68|STANDARD_DEVIATION|40.4||1|TWO_SIDED|90.0|256.24|406.34|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||406.34|256.24|1.0000
71649023|NCT01525628|142815566|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|145.93|STANDARD_DEVIATION|66.2||0.7461|TWO_SIDED|90.0|97.83|217.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||217.69|97.83|0.7461
71649024|NCT01525628|142815567|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|355.04|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|298.13|422.83|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||422.83|298.13|1.0000
71649025|NCT01525628|142815567|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|120.67|STANDARD_DEVIATION|58.3||0.4337|TWO_SIDED|90.0|83.68|174.01|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||174.01|83.68|0.4337
71649026|NCT01525628|142815568|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|397.73|STANDARD_DEVIATION|31.6||1|TWO_SIDED|90.0|330.79|478.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||478.22|330.79|1.0000
71649027|NCT01525628|142815568|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|142.27|STANDARD_DEVIATION|53.1||0.7346|TWO_SIDED|90.0|99.49|203.44|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||203.44|99.49|0.7346
71649028|NCT01525628|142815569|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|403.86|STANDARD_DEVIATION|33.6||1|TWO_SIDED|90.0|332.19|490.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||490.99|332.19|1.0000
71649029|NCT01525628|142815569|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|116.96|STANDARD_DEVIATION|73.1||0.3968|TWO_SIDED|90.0|75.38|181.47|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||181.47|75.38|0.3968
71649030|NCT01525628|142815570|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|408.66|STANDARD_DEVIATION|45.9||1|TWO_SIDED|90.0|315.15|529.9|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||529.90|315.15|1.0000
71649031|NCT01525628|142815570|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|301.19|STANDARD_DEVIATION|62.1||0.9993|TWO_SIDED|90.0|204.61|443.35|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||443.35|204.61|0.9993
71762745|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.8465|TWO_SIDED|90.0|-1.03|1.3|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.30|-1.03|0.8465
71649032|NCT01525628|142815571|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|450.51|STANDARD_DEVIATION|48.0||1|TWO_SIDED|90.0|343.67|590.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||590.57|343.67|1.0000
71649033|NCT01525628|142815571|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|341.96|STANDARD_DEVIATION|61.1||0.9996|TWO_SIDED|90.0|229.22|510.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||510.13|229.22|0.9996
71649034|NCT01525628|142815572|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|466.92|STANDARD_DEVIATION|47.6||1|TWO_SIDED|90.0|357.02|610.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||610.66|357.02|1.0000
71649035|NCT01525628|142815572|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|298.57|STANDARD_DEVIATION|79.2||0.9972|TWO_SIDED|90.0|187.22|476.15|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||476.15|187.22|0.9972
71649036|NCT01525628|142815573|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|528.95|STANDARD_DEVIATION|42.0||1|TWO_SIDED|90.0|415.88|672.75|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||672.75|415.88|1.0000
71649037|NCT01525628|142815573|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|384.0|STANDARD_DEVIATION|69.2||0.9998|TWO_SIDED|90.0|251.56|586.16|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||586.16|251.56|0.9998
71649038|NCT01525628|142815574|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|569.81|STANDARD_DEVIATION|42.2||1|TWO_SIDED|90.0|447.49|725.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||725.57|447.49|1.0000
71649039|NCT01525628|142815574|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|441.89|STANDARD_DEVIATION|66.9||0.9999|TWO_SIDED|90.0|286.81|680.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||680.82|286.81|0.9999
71649040|NCT01525628|142815575|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|606.29|STANDARD_DEVIATION|44.2||1|TWO_SIDED|90.0|471.42|779.74|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9||779.74|471.42|1.0000
71649041|NCT01525628|142815575|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|377.98|STANDARD_DEVIATION|82.0||0.9994|TWO_SIDED|90.0|233.48|611.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9||611.91|233.48|0.9994
71649042|NCT01525628|142815576|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|97.03|STANDARD_DEVIATION|30.8||0.05|TWO_SIDED|90.0|80.0|117.69|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||117.69|80.00|0.0500
71649043|NCT01525628|142815576|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|97.1|STANDARD_DEVIATION|31.2||0.0564|TWO_SIDED|90.0|79.37|118.79|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||118.79|79.37|0.0564
71886426|NCT00848354|143293313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.51|||<|0.0001|TWO_SIDED|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||11.38|3.72|<0.0001
71649044|NCT01525628|142815576|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|114.38|STANDARD_DEVIATION|31.9||0.2375|TWO_SIDED|90.0|92.36|141.66|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.66|92.36|0.2375
71649045|NCT01525628|142815576|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|139.07|STANDARD_DEVIATION|22.8||0.9082|TWO_SIDED|90.0|121.63|159.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||159.00|121.63|0.9082
71649046|NCT01525628|142815576|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|122.37|STANDARD_DEVIATION|29.3||0.4111|TWO_SIDED|90.0|104.11|143.84|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||143.84|104.11|0.4111
71649047|NCT01525628|142815576|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|121.43|STANDARD_DEVIATION|24.7||0.3719|TWO_SIDED|90.0|104.24|141.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||141.45|104.24|0.3719
71649048|NCT01525628|142815577|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|88.37|STANDARD_DEVIATION|20.8||0.1037|TWO_SIDED|90.0|77.39|100.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||100.89|77.39|0.1037
71649049|NCT01525628|142815577|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|159.11|STANDARD_DEVIATION|57.8||0.8723|TWO_SIDED|90.0|111.06|227.93|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||227.93|111.06|0.8723
71649050|NCT01525628|142815577|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|259.57|STANDARD_DEVIATION|92.5||0.983|TWO_SIDED|90.0|150.65|447.21|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||447.21|150.65|0.9830
71649051|NCT01525628|142815577|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|163.95|STANDARD_DEVIATION|38.1||0.9689|TWO_SIDED|90.0|129.52|207.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||207.52|129.52|0.9689
71649052|NCT01525628|142815577|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|219.88|STANDARD_DEVIATION|70.4||0.9933|TWO_SIDED|90.0|153.84|314.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||314.26|153.84|0.9933
71649053|NCT01525628|142815577|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|214.4|STANDARD_DEVIATION|66.8||0.9865|TWO_SIDED|90.0|145.88|315.09|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||315.09|145.88|0.9865
71649054|NCT01525628|142815578|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|96.06|STANDARD_DEVIATION|14.2||0.0015|TWO_SIDED|90.0|87.77|105.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||105.13|87.77|0.0015
71649055|NCT01525628|142815578|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|85.41|STANDARD_DEVIATION|17.2||0.1617|TWO_SIDED|90.0|76.32|95.57|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||95.57|76.32|0.1617
71762746|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|1.02||||0.1502|TWO_SIDED|90.0|-0.15|2.18|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||2.18|-0.15|0.1502
71649056|NCT01525628|142815578|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|73.26|STANDARD_DEVIATION|17.5||0.893|TWO_SIDED|90.0|65.03|82.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||82.54|65.03|0.8930
71649057|NCT01525628|142815578|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|92.23|STANDARD_DEVIATION|10.5||0.0005|TWO_SIDED|90.0|86.67|98.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||98.13|86.67|0.0005
71649058|NCT01525628|142815578|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|73.93|STANDARD_DEVIATION|21.6||0.8646|TWO_SIDED|90.0|65.55|83.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||83.39|65.55|0.8646
71649059|NCT01525628|142815578|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|75.42|STANDARD_DEVIATION|16.4||0.8378|TWO_SIDED|90.0|68.15|83.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.45|68.15|0.8378
71649060|NCT01525628|142815579|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|98.17|STANDARD_DEVIATION|12.3||0.0005|TWO_SIDED|90.0|90.15|106.91|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||106.91|90.15|0.0005
71649061|NCT01525628|142815579|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|81.26|STANDARD_DEVIATION|11.7||0.3638|TWO_SIDED|90.0|75.19|87.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||87.82|75.19|0.3638
71649062|NCT01525628|142815579|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.93|STANDARD_DEVIATION|22.6||0.8975|TWO_SIDED|90.0|60.44|83.22|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||83.22|60.44|0.8975
71649063|NCT01525628|142815579|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|86.37|STANDARD_DEVIATION|18.1||0.1144|TWO_SIDED|90.0|77.62|96.11|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||96.11|77.62|0.1144
71649064|NCT01525628|142815579|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|64.66|STANDARD_DEVIATION|11.8||1|TWO_SIDED|90.0|60.42|69.2|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||69.20|60.42|1.0000
71649065|NCT01525628|142815579|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|63.75|STANDARD_DEVIATION|17.3||0.9988|TWO_SIDED|90.0|57.19|71.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||71.07|57.19|0.9988
71649066|NCT01525628|142815580|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|144.78|STANDARD_DEVIATION|19.0||0.9749|TWO_SIDED|90.0|128.3|163.36|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||163.36|128.30|0.9749
71649067|NCT01525628|142815580|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|152.94|STANDARD_DEVIATION|26.8||0.9703|TWO_SIDED|90.0|128.6|181.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||181.89|128.60|0.9703
71886427|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.07||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||7.07|2.90|<0.0001
71649068|NCT01525628|142815580|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|102.99|STANDARD_DEVIATION|29.3||0.05|TWO_SIDED|90.0|84.85|124.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||124.99|84.85|0.0500
71649069|NCT01525628|142815580|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|124.22|STANDARD_DEVIATION|24.1||0.4697|TWO_SIDED|90.0|107.91|142.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||142.99|107.91|0.4697
71649070|NCT01525628|142815580|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|120.74|STANDARD_DEVIATION|19.2||0.2906|TWO_SIDED|90.0|108.47|134.38|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||134.38|108.47|0.2906
71649071|NCT01525628|142815580|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|93.95|STANDARD_DEVIATION|25.2||0.046|TWO_SIDED|90.0|80.33|109.86|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.86|80.33|0.0460
71649072|NCT01525628|142815581|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|151.66|STANDARD_DEVIATION|18.5||0.9941|TWO_SIDED|90.0|134.79|170.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||170.64|134.79|0.9941
71649073|NCT01525628|142815581|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|163.42|STANDARD_DEVIATION|26.0||0.9926|TWO_SIDED|90.0|137.91|193.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||193.64|137.91|0.9926
71649074|NCT01525628|142815581|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|98.14|STANDARD_DEVIATION|28.1||0.0392|TWO_SIDED|90.0|81.2|118.63|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||118.63|81.20|0.0392
71649075|NCT01525628|142815581|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|122.58|STANDARD_DEVIATION|37.2||0.4374|TWO_SIDED|90.0|99.15|151.55|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||151.55|99.15|0.4374
71649076|NCT01525628|142815581|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|130.44|STANDARD_DEVIATION|35.3||0.647|TWO_SIDED|90.0|107.57|158.18|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||158.18|107.57|0.6470
71824336|NCT00783692|143152514|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.9||||0.0154|TWO_SIDED|95.0|3.0|28.7||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||28.7|3.0|0.0154
71649077|NCT01525628|142815581|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|87.77|STANDARD_DEVIATION|36.9||0.2372|TWO_SIDED|90.0|70.32|109.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||109.54|70.32|0.2372
71762747|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.97|TWO_SIDED|90.0|-1.19|1.14|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.14|-1.19|0.9700
71649078|NCT01525628|142815582|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|117.67|STANDARD_DEVIATION|15.6||0.1519|TWO_SIDED|90.0|106.49|130.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||130.00|106.49|0.1519
71824337|NCT00783692|143152514|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.9||||0.045|TWO_SIDED|95.0|0.3|25.5||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||25.5|0.3|0.0450
71886428|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.36|6.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||6.80|2.36|<0.0001
71649079|NCT01525628|142815582|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|117.01|STANDARD_DEVIATION|30.9||0.2827|TWO_SIDED|90.0|96.06|142.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day17 vs. Day 1||142.52|96.06|0.2827
71649080|NCT01525628|142815582|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|92.11|STANDARD_DEVIATION|32.6||0.1326|TWO_SIDED|90.0|74.38|114.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||114.07|74.38|0.1326
71649081|NCT01525628|142815582|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|95.55|STANDARD_DEVIATION|29.2||0.0432|TWO_SIDED|90.0|80.63|113.24|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||113.24|80.63|0.0432
71649082|NCT01525628|142815582|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|75.19|STANDARD_DEVIATION|30.3||0.7367|TWO_SIDED|90.0|63.64|88.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||88.82|63.64|0.7367
71649083|NCT01525628|142815582|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.14|STANDARD_DEVIATION|34.3||0.8547|TWO_SIDED|90.0|56.84|86.56|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||86.56|56.84|0.8547
71649084|NCT01525628|142815583|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|102.7|STANDARD_DEVIATION|45.9||0.1159|TWO_SIDED|90.0|77.89|135.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||135.39|77.89|0.1159
71649085|NCT01525628|142815583|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|99.99|STANDARD_DEVIATION|38.7||0.0651|TWO_SIDED|90.0|78.33|127.64|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||127.64|78.33|0.0651
71649086|NCT01525628|142815583|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.29|STANDARD_DEVIATION|34.3||0.5658|TWO_SIDED|90.0|62.5|98.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||98.07|62.50|0.5658
71702459|NCT03086343|142921892|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.35||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|ANCOVA|The ANCOVA model included treatment as the fixed factor; corresponding baseline value and the stratification factor of prior bDMARD used as covariates|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||-0.35|-0.69|< 0.001
71649087|NCT01525628|142815583|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|108.25|STANDARD_DEVIATION|37.2||0.1286|TWO_SIDED|90.0|87.46|133.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1||133.99|87.46|0.1286
71649088|NCT01525628|142815583|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|87.59|STANDARD_DEVIATION|31.8||0.1898|TWO_SIDED|90.0|73.56|104.3|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1||104.30|73.56|0.1898
71649089|NCT01525628|142815583|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.42|STANDARD_DEVIATION|36.3||0.5575|TWO_SIDED|90.0|61.81|99.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 -was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1||99.51|61.81|0.5575
71649090|NCT00178711|142815638|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||=|0.67|TWO_SIDED|95.0|0.76|1.53|||Regression, Logistic|||The primary hypothesis was a two-sided test assessing whether the induction of hypothermia modified the percentage of subjects with poor outcomes at 6 months after injury. Percentages in each group were compared using a generalized linear model with a binomial distribution and log link function, logistic regression model with admission age and baseline GCS as covariates.||1.53|0.76|=0.67
71649091|NCT00948792|142815658|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.8
71649092|NCT00948792|142815659|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.26
71649093|NCT00948792|142815660|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."||||0.09
71649094|NCT01992094|142815661|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1||1.1|0.9|
71649095|NCT01992094|142815661|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||TWO_SIDED|95.0|0.9|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2||1.1|0.9|
71886429|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.0001|TWO_SIDED|95.0|2.82|9.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||9.72|2.82|<0.0001
71649096|NCT01992094|142815661|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.8|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.0|0.8|
71649097|NCT01992094|142815661|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||TWO_SIDED|95.0|0.9|1.0|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.0|0.9|
71649098|NCT01992094|142815662|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-0.5|||||TWO_SIDED|95.0|-5.3|4.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1||4.2|-5.3|
71649099|NCT01992094|142815662|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-2.7|||||TWO_SIDED|95.0|-7.2|1.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2||1.9|-7.2|
71649100|NCT01992094|142815662|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-1.8|||||TWO_SIDED|95.0|-6.2|2.8|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||2.8|-6.2|
71886430|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.25|||<|0.0001|TWO_SIDED|95.0|2.63|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||10.47|2.63|<0.0001
71649101|NCT01992094|142815662|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-4.4|||||TWO_SIDED|95.0|-8.9|0.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||0.2|-8.9|
71649102|NCT01992094|142815668|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.6|||||TWO_SIDED|95.0|0.6|0.7||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2||0.7|0.6|
71649103|NCT01992094|142815669|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-19.4|||||TWO_SIDED|95.0|-23.2|-15.5||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2||-15.5|-23.2|
71649104|NCT01992094|142815670|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.5|||||TWO_SIDED|95.0|0.5|0.5||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1||0.5|0.5|
71649105|NCT01992094|142815671|NON_INFERIORITY_OR_EQUIVALENCE|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-21.7|||||TWO_SIDED|95.0|-25.5|-17.7||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1||-17.7|-25.5|
71649106|NCT01214239|142815674|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.71|-0.28|||ANCOVA|||||-0.28|-0.71|<0.0001
71649107|NCT01214239|142815675|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001||95.0|-0.527|-0.238|||ANCOVA|||||-0.238|-0.527|<0.0001
71649108|NCT01214239|142815676|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.677|-0.323|||ANCOVA|||||-0.323|-0.677|<0.0001
71649109|NCT01214239|142815677|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.512|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001||95.0|-0.705|-0.318|||ANCOVA|||||-0.318|-0.705|<0.0001
71649110|NCT01214239|142815678|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.69|-0.23|||ANCOVA|||||-0.23|-0.69|0.0001
71649111|NCT01214239|142815679|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.1||0.0003||95.0|-17.2|-5.2|||ANCOVA|||||-5.2|-17.2|0.0003
71649112|NCT01214239|142815680|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.8|STANDARD_ERROR_OF_MEAN|3.3||0.0086||95.0|-15.4|-2.3|||ANCOVA|||||-2.3|-15.4|0.0086
71649113|NCT01214239|142815681|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.5|STANDARD_ERROR_OF_MEAN|3.8||0.0135||95.0|-17.0|-2.0|||ANCOVA|||||-2.0|-17.0|0.0135
71649114|NCT01214239|142815682|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|3.8||0.0113||95.0|-17.1|-2.2|||ANCOVA|||||-2.2|-17.1|0.0113
71702460|NCT03086343|142921893|SUPERIORITY||Mean Difference|16.8|||<|0.001|TWO_SIDED|95.0|10.4|23.2||This comparison was a ranked secondary endpoint in the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|The stratification factor of prior failed bDMARD was used.|Treatment Difference = Upadacitinib 15 mg - Abatacept|In order to preserve Type I error, a step-down approach was used to test the primary and ranked secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.||23.2|10.4|< 0.001
71886431|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.0001|TWO_SIDED|95.0|3.16|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||13.48|3.16|<0.0001
71649115|NCT01214239|142815684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.552||||0.0021||95.0|1.407|4.629|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 7.0%||4.629|1.407|0.0021
71649116|NCT01214239|142815686|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.583||||0.25||95.0|0.724|3.46|||Regression, Logistic|||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||3.46|0.724|0.2500
71649117|NCT01214239|142815687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.527||||0.0005||95.0|1.494|4.276|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||||4.276|1.494|0.0005
71649118|NCT01049581|142815688|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA was used and the result reveled (F1, 17 = 7.565, η2= 0.308, p = 0.007)||||||0.007|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy group||||0.007
71649119|NCT01049581|142815689|NON_INFERIORITY_OR_EQUIVALENCE|ANCOVA : p value 0.393|Mean Difference (Net)|1.762||||0.393|ONE_SIDED|95.0||||"Effect Size η2~0.023"|ANCOVA|F1,17= 0.380||We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADL||||0.393
71649120|NCT01049581|142815690|SUPERIORITY_OR_OTHER|||||||0.332|ONE_SIDED|95.0|||||ANCOVA|||null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy group||||0.332
71649121|NCT03203642|142815691|SUPERIORITY||LS mean difference|-0.0052|STANDARD_ERROR_OF_MEAN|0.0082||0.5265|TWO_SIDED|95.0|-0.0217|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0112|-0.0217|0.5265
71649122|NCT03203642|142815692|SUPERIORITY||LS mean difference|-0.0042|STANDARD_ERROR_OF_MEAN|0.0111||0.7076|TWO_SIDED|95.0|-0.0264|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0180|-0.0264|0.7076
71649123|NCT03203642|142815693|SUPERIORITY||LS mean difference|-0.0122|STANDARD_ERROR_OF_MEAN|0.014||0.3895|TWO_SIDED|95.0|-0.0404|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0160|-0.0404|0.3895
71649124|NCT03203642|142815694|SUPERIORITY||LS mean difference|0.0015|STANDARD_ERROR_OF_MEAN|0.0131||0.9093|TWO_SIDED|95.0|-0.0248|||Threshold for significance at 0.05 level.|ANCOVA|||An ANCOVA model included treatment group as a factor and the Baseline htTKV (log10 transformed) as a covariate for the analysis. The outcome measure was tested at 2-sided 0.05 level to control Type I error rate.||- 0.0278|-0.0248|0.9093
71649125|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.08|||||TWO_SIDED|95.0|35.22|74.08||||||TAK-272F: Least square mean (LS) mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95 percent (%) confidence intervals (CI) were calculated using an analysis of variance (ANOVA) model for natural log-transformed data.||74.08|35.22|
71649126|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|117.95|||||TWO_SIDED|95.0|81.32|171.07||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.07|81.32|
71649127|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.87|||||TWO_SIDED|95.0|188.14|395.76||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.76|188.14|
71649128|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|183.27|||||TWO_SIDED|95.0|126.36|265.81||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||265.81|126.36|
71649129|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.67|||||TWO_SIDED|95.0|68.95|149.9||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.90|68.95|
71649130|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.98|||||TWO_SIDED|95.0|92.23|200.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||200.50|92.23|
71649131|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|62.34|||||TWO_SIDED|95.0|36.17|107.45||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||107.45|36.17|
71649132|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|93.2|||||TWO_SIDED|95.0|54.08|160.64||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||160.64|54.08|
71649133|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|274.21|||||TWO_SIDED|95.0|159.1|472.63||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||472.63|159.10|
71649134|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|261.12|||||TWO_SIDED|95.0|151.5|450.05||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||450.05|151.50|
71649135|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|112.47|||||TWO_SIDED|95.0|69.34|182.41||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||182.41|69.34|
71649136|NCT02367872|142815697|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|176.75|||||TWO_SIDED|95.0|108.97|286.67||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||286.67|108.97|
71649137|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|57.36|||||TWO_SIDED|95.0|37.76|87.14||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||87.14|37.76|
71649138|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|77.04|||||TWO_SIDED|95.0|50.72|117.03||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||117.03|50.72|
71649139|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|206.41|||||TWO_SIDED|95.0|135.88|313.54||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||313.54|135.88|
71649140|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|143.11|||||TWO_SIDED|95.0|94.21|217.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||217.39|94.21|
71649141|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|85.31|||||TWO_SIDED|95.0|51.03|142.61||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||142.61|51.03|
71649142|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|131.63|||||TWO_SIDED|95.0|78.74|220.04||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||220.04|78.74|
71649143|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|70.38|||||TWO_SIDED|95.0|40.42|122.53||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||122.53|40.42|
71649144|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|55.03|||||TWO_SIDED|95.0|31.61|95.81||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||95.81|31.61|
71649145|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|125.96|||||TWO_SIDED|95.0|72.35|219.3||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||219.30|72.35|
71649146|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|103.93|||||TWO_SIDED|95.0|59.7|180.95||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||180.95|59.70|
71649147|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|91.97|||||TWO_SIDED|95.0|49.45|171.06||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.06|49.45|
71649148|NCT02367872|142815698|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.33|||||TWO_SIDED|95.0|74.91|259.15||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||259.15|74.91|
71649149|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|51.39|||||TWO_SIDED|95.0|35.45|74.49||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||74.49|35.45|
71649150|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|118.43|||||TWO_SIDED|95.0|81.7|171.68||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||171.68|81.70|
71649151|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|272.83|||||TWO_SIDED|95.0|188.21|395.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||395.50|188.21|
71649152|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|184.13|||||TWO_SIDED|95.0|127.02|266.91||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||266.91|127.02|
71649153|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|101.64|||||TWO_SIDED|95.0|69.04|149.64||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||149.64|69.04|
71886432|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.38|||<|0.0001|TWO_SIDED|95.0|3.86|18.17||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||18.17|3.86|<0.0001
71649154|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|136.59|||||TWO_SIDED|95.0|92.78|201.09||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||201.09|92.78|
71649155|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|59.17|||||TWO_SIDED|95.0|33.99|102.99||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.99|33.99|
71762748|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-1.18||||0.0947|TWO_SIDED|90.0|-2.34|-0.02|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.34|0.0947
71649156|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.04|||||TWO_SIDED|95.0|55.75|168.9||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||168.90|55.75|
71649157|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|260.03|||||TWO_SIDED|95.0|149.39|452.6||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||452.60|149.39|
71649158|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|319.06|||||TWO_SIDED|95.0|183.31|555.34||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||555.34|183.31|
71649159|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|130.07|||||TWO_SIDED|95.0|81.66|207.18||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.18|81.66|
71649160|NCT02367872|142815699|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|192.63|||||TWO_SIDED|95.0|120.94|306.83||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||306.83|120.94|
71649161|NCT02367872|142815700|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.22|||||TWO_SIDED|95.0|40.05|90.56||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||90.56|40.05|
71649162|NCT02367872|142815700|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|97.39|||||TWO_SIDED|95.0|64.77|146.46||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||146.46|64.77|
71649163|NCT02367872|142815700|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.6|||||TWO_SIDED|95.0|74.21|167.82||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.82|74.21|
71649164|NCT02367872|142815700|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|138.79|||||TWO_SIDED|95.0|92.29|208.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||208.70|92.29|
71649165|NCT02367872|142815700|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.18|||||TWO_SIDED|95.0|87.91|207.87||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.87|87.91|
71649166|NCT02367872|142815700|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|323.75|||||TWO_SIDED|95.0|210.54|497.85||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||497.85|210.54|
71649167|NCT02367872|142815701|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|67.61|||||TWO_SIDED|95.0|42.17|108.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||108.39|42.17|
71649168|NCT02367872|142815701|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|63.7|||||TWO_SIDED|95.0|39.73|102.12||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||102.12|39.73|
71649169|NCT02367872|142815701|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|84.45|||||TWO_SIDED|95.0|52.67|135.38||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||135.38|52.67|
71649170|NCT02367872|142815701|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|108.54|||||TWO_SIDED|95.0|67.7|174.01||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||174.01|67.70|
71649171|NCT02367872|142815701|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|113.25|||||TWO_SIDED|95.0|69.62|184.24||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||184.24|69.62|
71649172|NCT02367872|142815701|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|312.89|||||TWO_SIDED|95.0|192.34|509.0||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||509.00|192.34|
71649173|NCT02367872|142815702|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|60.68|||||TWO_SIDED|95.0|40.35|91.27||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||91.27|40.35|
71649174|NCT02367872|142815702|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|98.01|||||TWO_SIDED|95.0|65.17|147.41||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||147.41|65.17|
71649175|NCT02367872|142815702|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|111.68|||||TWO_SIDED|95.0|74.25|167.96||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||167.96|74.25|
71649176|NCT02367872|142815702|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|139.7|||||TWO_SIDED|95.0|92.88|210.11||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||210.11|92.88|
71886433|NCT00848354|143293315|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.94|15.62||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||15.62|3.94|<0.0001
71649177|NCT02367872|142815702|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|135.08|||||TWO_SIDED|95.0|87.75|207.92||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||207.92|87.75|
71649178|NCT02367872|142815702|SUPERIORITY_OR_OTHER||LS Mean Cohort Ratio (%)|325.28|||||TWO_SIDED|95.0|211.32|500.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.||500.70|211.32|
71649179|NCT02625298|142815714|OTHER||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71649180|NCT05068284|142815717|SUPERIORITY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-6.3|20.6|||||Risk difference = (ABBV-154 - placebo)|||20.6|-6.3|
71649181|NCT05068284|142815717|SUPERIORITY||Risk Difference (RD)|33.3|||||TWO_SIDED|95.0|6.7|60.0|||||Risk difference = (ABBV-154 - placebo)|||60.0|6.7|
71649182|NCT05068284|142815717|SUPERIORITY||Risk Difference (RD)|28.6|||||TWO_SIDED|95.0|4.9|52.2|||||Risk difference = (ABBV-154 - placebo)|||52.2|4.9|
71649183|NCT05068284|142815717|SUPERIORITY||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|1.0|53.6|||||Risk difference = (ABBV-154 - placebo)|||53.6|1.0|
71649184|NCT05068284|142815718|SUPERIORITY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-19.8|43.6|||||Risk difference = (ABBV-154 - placebo)|||43.6|-19.8|
71649185|NCT05068284|142815718|SUPERIORITY||Risk Difference (RD)|29.5|||||TWO_SIDED|95.0|-4.8|63.8|||||Risk difference = (ABBV-154 - placebo)|||63.8|-4.8|
71649186|NCT05068284|142815718|SUPERIORITY||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|-13.7|51.8|||||Risk difference = (ABBV-154 - placebo)|||51.8|-13.7|
71649187|NCT05068284|142815718|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|-13.6|60.3|||||Risk difference = (ABBV-154 - placebo)|||60.3|-13.6|
71649188|NCT05068284|142815719|SUPERIORITY||Risk Difference (RD)|11.3|||||TWO_SIDED|95.0|-18.5|41.0|||||Risk difference = (ABBV-154 - placebo)|||41.0|-18.5|
71649189|NCT05068284|142815719|SUPERIORITY||Risk Difference (RD)|38.5|||||TWO_SIDED|95.0|5.0|71.9|||||Risk difference = (ABBV-154 - placebo)|||71.9|5.0|
71649190|NCT05068284|142815719|SUPERIORITY||Risk Difference (RD)|24.6|||||TWO_SIDED|95.0|-7.0|56.2|||||Risk difference = (ABBV-154 - placebo)|||56.2|-7.0|
71649191|NCT05068284|142815719|SUPERIORITY||Risk Difference (RD)|39.2|||||TWO_SIDED|95.0|3.8|74.5|||||Risk difference = (ABBV-154 - placebo)|||74.5|3.8|
71649192|NCT01074008|142815758|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
71649193|NCT01074008|142815758|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
71649194|NCT01074008|142815758|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide \> 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
71649195|NCT01074008|142815758|SUPERIORITY_OR_OTHER|||||||0.009||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.009
71649196|NCT01074008|142815758|SUPERIORITY_OR_OTHER|||||||0.012||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.012
71649197|NCT01074008|142815758|SUPERIORITY_OR_OTHER||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||<0.001
71649198|NCT01074008|142815758|SUPERIORITY_OR_OTHER|||||||0.032||||||There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.||||0.032
71649199|NCT01074008|142815758|SUPERIORITY_OR_OTHER|||||||0.053||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.||||0.053
71649200|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.001
71649201|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.006
71649202|NCT01074008|142815759|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
71649203|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.262
71649204|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||1.000
71649205|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.245
71649206|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
71649207|NCT01074008|142815759|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.111
71649208|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71649209|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.059
71649210|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71649211|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71649212|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.370
71649213|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71824338|NCT00783692|143152515|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2||||0.1036|TWO_SIDED|95.0|-1.5|16.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||16.0|-1.5|0.1036
71649214|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71649215|NCT01074008|142815760|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71649216|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
71649217|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
71649218|NCT01074008|142815773|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||<0.001
71649219|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.024
71649220|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.319|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.319
71649221|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.013
71649222|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.005
71649223|NCT01074008|142815773|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact|||||||0.074
71649224|NCT01350934|142815796|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|1.95|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|0.8|3.1|||Longitudinal data analysis|||||3.1|0.8|<0.001
71649225|NCT01350934|142815797|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|2.92|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|1.8|4.1|||Longitudinal data analysis|||||4.1|1.8|<0.001
71649226|NCT01350934|142815798|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-42.37|||<|0.001|TWO_SIDED|95.0|-48.16|-36.67|||Constrained longitudinal data analysis|||||-36.67|-48.16|<0.001
71649227|NCT01350934|142815799|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-52.03|||<|0.001|TWO_SIDED|95.0|-59.04|-45.3|||Constrained longitudinal data analysis|||||-45.30|-59.04|<0.001
71649228|NCT01350934|142815800|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.07|||<|0.001|TWO_SIDED|95.0|-57.29|-44.99|||Constrained longitudinal data analysis|||||-44.99|-57.29|<0.001
71649229|NCT01350934|142815801|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-51.96|||<|0.001|TWO_SIDED|95.0|-58.77|-45.39|||Constrained longitudinal data analysis|||||-45.39|-58.77|<0.001
71649230|NCT01350934|142815802|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0279|||<|0.001|TWO_SIDED|95.0|0.0074|0.1048|||Cochran-Mantel-Haenszel|||Odds Ratio comparison of percentage of participants with \<20 ng/mL of serum 25-hydroxyvitamin (OH) D between Fosamax Plus group and Calcitriol group.||0.1048|0.0074|<0.001
71649231|NCT00493792|142815812|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.47|TWO_SIDED|95.0|0.29|1.77|||Regression, Cox|||||1.77|0.29|0.47
71649232|NCT00493792|142815813|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.06|TWO_SIDED|95.0|0.23|1.03|||Regression, Cox|||||1.03|0.23|0.06
71649233|NCT00493792|142815814|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.193|TWO_SIDED|95.0|0.45|1.18|||Regression, Cox|||||1.18|.45|0.193
71649234|NCT00685035|142815820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.23||0.02|TWO_SIDED|95.0|||||ANCOVA|||||||.02
71649235|NCT04241133|142815824|OTHER|The experimental and control groups were not compared due to the inability to collect post data with the control group because of stay at home orders during the COVID-19 pandemic.|||||<|0.05||||||The reported P-value was calculated.|t-test, 2 sided|The a priori threshold for statistical significance was P\<0.05.||The experimental group was tested for significant difference in Healthy Eating Index 2015 (HEI-2015) scores at baseline and 12 weeks. SAS macros provided by the National Cancer Institute were used to compute HEI-2015 scores for each dietary recall at pre- (baseline) and post-intervention (12 weeks) using the Simple HEI Scoring Algorithm.||||<0.05
71649236|NCT00687739|142815946|SUPERIORITY|The primary analysis compared the GnRHAG + E2 and GnRHAG + PL groups, pooled across exercise status. It was acknowledged that the inclusion of exercisers could minimize the effects of GnRHAG but would be reflective of the effects of ovarian hormone suppression on sedentary and active women. Differences in changes across time between groups were tested using an analysis of covariance model conditioned on baseline.|||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the effect of PL vs E2 collapsed across exercise (2-group comparison). The analysis of effects of exercise was exploratory (evaluated within-group changes only).||||<0.05
71649237|NCT00687739|142815947|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the comparison of within-group changes in the E2 and placebo groups for cortisol AUC in response to Dex/CRH and between-group differences in the changes. Within-group changes and between-group differences in changes were evaluated by linear contrast using an ANCOVA model with adjustment for pre-intervention values of outcomes.||||<0.05
71649238|NCT00687739|142815948|SUPERIORITY||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis compared the GnRHag+E2 and GnRHag+PL groups, pooled across exercise status. Differences in change over time between groups were tested by using an ANCOVA model, first with treatment group alone, and again adding FM and FFM to the model.||||<0.05
71649239|NCT01653405|142816003|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
71649240|NCT01653405|142816004|SUPERIORITY|||||||0.43|||||||test of differences|||||||0.43
71649241|NCT01653405|142816005|SUPERIORITY||||||<|0.001|||||||difference in differences|||||||<0.001
71649242|NCT01653405|142816006|SUPERIORITY||||||<|0.001|||||||Difference in differences|||||||<0.001
71649243|NCT01653405|142816007|SUPERIORITY|||||||0.002|||||||difference in differences|||||||0.002
71649244|NCT00345033|142816036|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in total cholesterol is over 99%.||||||0.125||95.0|||||ANCOVA|||||||0.125
71649245|NCT00345033|142816037|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in weight will be over 99%.||||||0.109||95.0|||||ANCOVA|||||||0.109
71649246|NCT00345033|142816038|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Body Mass Index (BMI) will be over 99%.||||||0.229||95.0|||||ANCOVA|||||||0.229
71649247|NCT00345033|142816039|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in glucose metabolism to be 90%.||||||0.01||95.0|||||ANCOVA|||||||0.010
71649248|NCT00345033|142816040|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in triglycerides will be 81%.||||||0.982||95.0|||||ANCOVA|||||||0.982
71649249|NCT00345033|142816041|NON_INFERIORITY_OR_EQUIVALENCE|A priori power calculation determined the power to detect a change in Insulin Resistance will be 90%.||||||0.082||95.0|||||ANCOVA|||||||0.082
71649250|NCT01881737|142816043|SUPERIORITY_OR_OTHER|||||||0.848|||||||Paired t test|||Effect Size Cohen's d = -0.05||||0.848
71649251|NCT01881737|142816044|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t test|Effect Size Cohen's d = 0.53||||||0.009
71649252|NCT01881737|142816045|SUPERIORITY_OR_OTHER|||||||0.38|||||||paired t test|Effect size Cohen's d = 0.38||||||0.38
71649253|NCT01881737|142816047|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71649254|NCT02102932|142816059|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.29|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|101.92|108.78||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.78|101.92|0.0000
71649255|NCT02102932|142816059|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.23|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.91|106.65||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.65|99.91|0.0000
71649256|NCT02102932|142816059|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.56|STANDARD_DEVIATION|7.6||0|TWO_SIDED|90.0|99.73|107.54||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.54|99.73|0.0000
71649257|NCT02102932|142816059|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.81|STANDARD_DEVIATION|6.9||0|TWO_SIDED|90.0|99.36|106.37||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.37|99.36|0.0000
71649258|NCT02102932|142816060|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.56|STANDARD_DEVIATION|14.0||0.0001|TWO_SIDED|90.0|97.56|112.07||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.07|97.56|0.0001
71649259|NCT02102932|142816060|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.8|STANDARD_DEVIATION|12.8||0.0001|TWO_SIDED|90.0|99.32|112.7||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.70|99.32|0.0001
71649260|NCT02102932|142816060|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.75|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|98.18|109.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.63|98.18|0.0000
71649261|NCT02102932|142816060|SUPERIORITY_OR_OTHER||Ratio of the geometric means|95.77|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|89.88|102.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||102.03|89.88|0.0000
71649262|NCT02102932|142816061|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.44|STANDARD_DEVIATION|11.8||0|TWO_SIDED|90.0|100.44|112.8||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.80|100.44|0.0000
71649263|NCT02102932|142816061|SUPERIORITY_OR_OTHER||Ratio of the geometric means|110.78|STANDARD_DEVIATION|13.2||0.0021|TWO_SIDED|90.0|103.8|118.24||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||118.24|103.80|0.0021
71649264|NCT02102932|142816061|SUPERIORITY_OR_OTHER||Ratio of the geometric means|101.38|STANDARD_DEVIATION|13.6||0|TWO_SIDED|90.0|94.82|108.39||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.39|94.82|0.0000
71649265|NCT02102932|142816061|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.02|STANDARD_DEVIATION|16.3||0.0002|TWO_SIDED|90.0|95.08|111.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.63|95.08|0.0002
71649266|NCT02102932|142816062|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.91|STANDARD_DEVIATION|11.2||0|TWO_SIDED|90.0|99.29|110.86||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||110.86|99.29|0.0000
71649267|NCT02102932|142816062|SUPERIORITY_OR_OTHER||Ratio of the geometric means|106.32|STANDARD_DEVIATION|15.7||0.0008|TWO_SIDED|90.0|98.39|114.88||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||114.88|98.39|0.0008
71660975|NCT03970837|142835410|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.87|3.53|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.53|1.87|<0.0001
71824339|NCT00783692|143152515|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.0||||0.6413|TWO_SIDED|95.0|-6.3|10.2||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.||10.2|-6.3|0.6413
71824340|NCT05550337|143152534|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|0.998|||||TWO_SIDED|90.0|0.927|1.076||||||||1.076|0.927|
71824341|NCT05550337|143152535|EQUIVALENCE|The 90% CI for the Test-to-Reference ratio of LS mean percent reduction from Baseline to Week 12/Day 84, in the non-inflammatory lesion counts to be contained within (0.80, 1.25).|Mean Difference (Net)|1.116|||||TWO_SIDED|90.0|1.017|1.228||||||||1.228|1.017|
71649268|NCT02102932|142816062|SUPERIORITY_OR_OTHER||Ratio of the geometric means|104.44|STANDARD_DEVIATION|15.7||0.0003|TWO_SIDED|90.0|96.68|112.82||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.82|96.68|0.0003
71649269|NCT02102932|142816062|SUPERIORITY_OR_OTHER||Ratio of the geometric means|96.61|STANDARD_DEVIATION|16.9||0.0004|TWO_SIDED|90.0|88.9|104.99||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||104.99|88.90|0.0004
71649270|NCT02102932|142816063|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.16|STANDARD_DEVIATION|6.2||0|TWO_SIDED|90.0|101.97|108.45||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||108.45|101.97|0.0000
71649271|NCT02102932|142816063|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.07|STANDARD_DEVIATION|6.6||0|TWO_SIDED|90.0|99.75|106.5||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.50|99.75|0.0000
71649272|NCT02102932|142816063|SUPERIORITY_OR_OTHER||Ratio of the geometric means|103.14|STANDARD_DEVIATION|7.5||0|TWO_SIDED|90.0|99.37|107.04||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||107.04|99.37|0.0000
71649273|NCT02102932|142816063|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.61|STANDARD_DEVIATION|7.0||0|TWO_SIDED|90.0|99.1|106.25||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||106.25|99.10|0.0000
71649274|NCT02102932|142816064|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.33|STANDARD_DEVIATION|11.9||0|TWO_SIDED|90.0|99.34|111.68||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||111.68|99.34|0.0000
71649275|NCT02102932|142816064|SUPERIORITY_OR_OTHER||Ratio of the geometric means|105.75|STANDARD_DEVIATION|13.2||0.0001|TWO_SIDED|90.0|99.09|112.85||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||112.85|99.09|0.0001
71649276|NCT02102932|142816064|SUPERIORITY_OR_OTHER||Ratio of the geometric means|102.9|STANDARD_DEVIATION|11.7||0|TWO_SIDED|90.0|97.11|109.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||109.03|97.11|0.0000
71649277|NCT02102932|142816064|SUPERIORITY_OR_OTHER||Ratio of the geometric means|93.84|STANDARD_DEVIATION|13.6||0.0002|TWO_SIDED|90.0|87.74|100.36||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed."||100.36|87.74|0.0002
71886434|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.35|5.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.||5.73|2.35|<0.0001
71649278|NCT02250651|142816065|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738|TWO_SIDED|95.0|-1.17|0.44|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.44|-1.17|0.3738
71649279|NCT02250651|142816065|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514|TWO_SIDED|95.0|-0.88|0.73|||MMRM|||Change from Baseline at Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.73|-0.88|0.8514
71649280|NCT02250651|142816065|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401|TWO_SIDED|95.0|-1.57|-0.04|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.04|-1.57|0.0401
71649281|NCT02250651|142816065|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Change from Baseline at Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.41|-1.12|0.3621
71649282|NCT02250651|142816066|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382||95.0|-1.48|-0.04|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
71649283|NCT02250651|142816066|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133||95.0|-1.29|0.14|||MMRM|||Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
71649284|NCT02250651|142816067|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013||95.0|-1.76|-0.43|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
71649285|NCT02250651|142816067|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364||95.0|-1.38|-0.05|||MMRM|||Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
71649286|NCT02250651|142816068|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304||95.0|-1.22|0.29|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
71824342|NCT02266329|143152569|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|1.6||0.034|TWO_SIDED|95.0|-6.9|-0.8||The significance of the study visit by treatment interaction with study visit coded as baseline, 4 weeks, 8 weeks, and 12 weeks.|Mixed Models Analysis|||Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.||-0.8|-6.9|0.034
71824343|NCT03499600|143152599|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on caregiver perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
71824344|NCT03499600|143152599|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.68|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on caregiver satisfaction with the intake.||||.68
71649287|NCT02250651|142816068|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272||95.0|-1.34|0.17|||MMRM|||Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
71649288|NCT02250651|142816069|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038||95.0|-1.76|-0.34|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
71649289|NCT02250651|142816069|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741||95.0|-1.36|0.06|||MMRM|||Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
71649290|NCT02250651|142816070|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.41||0.3738||95.0|-1.17|0.44|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.44|-1.17|0.3738
71649291|NCT02250651|142816070|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.41||0.8514||95.0|-0.88|0.73|||MMRM|||Week 12, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.73|-0.88|0.8514
71649292|NCT02250651|142816071|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0401||95.0|-1.57|-0.04|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.57|0.0401
71649293|NCT02250651|142816071|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.39||0.3621|TWO_SIDED|95.0|-1.12|0.41|||MMRM|||Week 12, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.41|-1.12|0.3621
71649294|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.36||0.0382|TWO_SIDED|95.0|-1.48|-0.04|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.48|0.0382
71649295|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.36||0.1133|TWO_SIDED|95.0|-1.29|0.14|||MMRM|||Change from Baseline at Week 2, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.14|-1.29|0.1133
71649296|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0013|TWO_SIDED|95.0|-1.76|-0.43|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.43|-1.76|0.0013
71649297|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.34||0.0364|TWO_SIDED|95.0|-1.38|-0.05|||MMRM|||Change from Baseline at Week 2, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.05|-1.38|0.0364
71649298|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2304|TWO_SIDED|95.0|-1.22|0.29|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.29|-1.22|0.2304
71649299|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.1272|TWO_SIDED|95.0|-1.34|0.17|||MMRM|||Change from Baseline at Week 6, Hour 0: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.17|-1.34|0.1272
71649300|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.0038|TWO_SIDED|95.0|-1.76|-0.34|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.76|0.0038
71649301|NCT02250651|142816072|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.36||0.0741|TWO_SIDED|95.0|-1.36|0.06|||MMRM|||Change from Baseline at Week 6, Hour 2: The hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \<0 mmHg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.06|-1.36|0.0741
71649302|NCT03496298|142816073|NON_INFERIORITY|Non-inferiority of efpeglenatide 4 mg+6 mg versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Hazard Ratio (HR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.583|0.918||One-sided p-value based on log rank test of hazard ratio for the incidence of both 1.8 and less and 1.3 or less.|Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|<.0001
71649303|NCT03496298|142816074|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.732||||0.0069|TWO_SIDED|95.0|0.583|0.918||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.918|0.583|0.0069
71649304|NCT03496298|142816075|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.79||||0.02|TWO_SIDED|95.0|0.65|0.96||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.96|0.65|0.02
71649305|NCT03496298|142816076|SUPERIORITY|Superiority was claimed when the upper bound of the 2-sided 95% CI of hazard ratio was less than 1.|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.574|0.794||Two-sided p-values based on log rank test of hazard ratio.|Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model with region (North America, Latin America, Europe, other), randomization stratum of SGLT2 inhibitor use (current use, potential future use, neither current nor potential future use) and treatment (efpeglenatide 4 mg, efpeglenatide 6 mg, placebo) as fixed effect factor.||0.794|0.574|<.0001
71649306|NCT01658995|142816077|SUPERIORITY||Risk Difference (RD)|-9.9||||0.37|TWO_SIDED|95.0|-31.4|11.6|||Chi-squared|||||11.6|-31.4|0.37
71649307|NCT01658995|142816078|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71762749|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.7759|TWO_SIDED|90.0|-0.96|1.36|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.36|-0.96|0.7759
71824345|NCT03499600|143152599|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.03|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed.This linear regressions tested condition effects on provider perceptions of the extent to which the provider understood the caregivers' values or what is important to them.||||.03
71824346|NCT03499600|143152599|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.|||||<|0.05|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. This linear regressions tested condition effects on provider satisfaction with the intake.||||<.05
71649308|NCT02522780|142816089|SUPERIORITY||Odds Ratio (OR)|1.57|||>|0.05|TWO_SIDED|95.0|0.96|2.54||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||2.54|0.96|>0.05
71649309|NCT02522780|142816090|SUPERIORITY||Odds Ratio (OR)|1.24|||>|0.05|TWO_SIDED|95.0|0.76|2.03||The p-value was based on Generalized estimating equations (GEE) approach with binary outcomes (clinical remission) and an unstructured working correlation matrix, at a 0.05 significance level.|Generalised estimating equation approach|||Proportions were compared between treatment groups over 6 months.||2.03|0.76|>0.05
71649310|NCT02522780|142816091|SUPERIORITY||Hazard Ratio (HR)|0.6|||>|0.05|TWO_SIDED|95.0|0.25|1.44||The p-value was based on log-rank test using pathway of randomization as the stratification factor, at a 0.05 significance level.|Log Rank|||Times to relapse were compared between treatment groups up to 6 months.||1.44|0.25|>0.05
71649311|NCT02522780|142816092|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.05|TWO_SIDED|95.0|0.19|0.79||The p-value was based on Cochran-Mantel-Haenszel test by controlling pathway of randomization, at a 0.05 significance level.|Cochran-Mantel-Haenszel|||Proportions were compared between treatment groups at Month 6.||0.79|0.19|<0.05
71649312|NCT02522780|142816093|SUPERIORITY||Mean difference|-1.0|||>|0.05|TWO_SIDED|95.0|-2.7|0.7||The p-value was based on a repeated-measures analysis of covariance (ANCOVA) model with an unstructured correlation matrix , at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in CRP levels over 6 months was reported.||0.7|-2.7|>0.05
71649313|NCT02522780|142816094|SUPERIORITY||Mean difference|-66.92|||>|0.05|TWO_SIDED|95.0|-140.2|6.36||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in fecal calprotectin levels over 6 months was reported.||6.36|-140.2|>0.05
71649314|NCT02522780|142816095|SUPERIORITY||Mean difference|-0.32|||>|0.05|TWO_SIDED|95.0|-4.41|3.77||The p-value was based on a repeated-measures ANCOVA model with an unstructured correlation matrix, at a 0.05 significance level.|ANCOVA|||Adjusted mean treatment difference in IBDQ total scores over 6 months was reported.||3.77|-4.41|>0.05
71649315|NCT00926367|142816218|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.||||||>0.05
71649316|NCT00926367|142816220|SUPERIORITY_OR_OTHER||||||>|0.05||||||A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|Dunn's Multiple Comparisons Test|||||||>0.05
71649317|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.38|0.35||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.35|-0.38|
71649318|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.6|0.13||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.60|
71649319|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.7|0.15||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.70|
71649320|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.93|-0.07||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.93|
71762750|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.9649|TWO_SIDED|90.0|-1.13|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.19|-1.13|0.9649
71824347|NCT03499600|143152601|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.93|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on therapeutic alliance.||||.93
71649321|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.69|0.33||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.33|-0.69|
71649322|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.09|-0.06||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.06|-1.09|
71649323|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.94|0.27||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.27|-0.94|
71649324|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.21|0.0||||||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.00|-1.21|
71649325|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.24|-0.03||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-1.24|
71649326|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.84|0.38||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.38|-0.84|
71649327|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.53|0.01||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.01|-1.53|
71649328|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.07|0.47||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.47|-1.07|
71649329|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.65|-0.08||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-1.65|
71649330|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.06|0.55||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.55|-1.06|
71649331|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.72|-0.15||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.72|
71824348|NCT03499600|143152601|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Tested the moderation effects of language of service reception and condition on therapeutic alliance.||||.90
71824349|NCT03499600|143152602|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery. Baseline ECBI score was included as a covariate for the treatment response analyses.||||||0.171|||||||Regression, Logistic|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A logistic regression tested condition effects on treatment response.||||.171
71649332|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.05|0.54||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.54|-1.05|
71649333|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.15||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.15|-1.80|
71649334|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.04|0.61||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.61|-1.04|
71649335|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.65|-0.05||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.05|-1.65|
71649336|NCT02725411|142816264|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.88|0.71||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.71|-0.88|
71649337|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.77|0.04||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.04|-1.77|
71649338|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.96|-0.14||||||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||-0.14|-1.96|
71649339|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.48|0.43||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.43|-1.48|
71649340|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.43|0.51||||||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.51|-1.43|
71649341|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.04|0.91||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.91|-1.04|
71649342|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.53|0.44||||||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.44|-1.53|
71649343|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.06|1.05||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.05|-1.06|
71649344|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.6|0.53||||||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.53|-1.60|
71649345|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.71|0.88||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.88|-1.71|
71649346|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.47|1.14||||||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.14|-1.47|
71649347|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.9|0.71||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.71|-1.90|
71649348|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.44|1.25||||||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.25|-1.44|
71649349|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.43|0.28||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.28|-2.43|
71738832|NCT04124705|142990541|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-15.16|||||TWO_SIDED|95.0|-26.1|-4.23|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for the primary efficacy endpoint, sustained TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance (equivalent to a two-sided 5% level of significance).||-4.23|-26.10|
71824350|NCT03499600|143152602|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Testes the effects of the moderation of language of service delivery and condition on treatment response.||||<.05
71649350|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.41|1.32||||||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.32|-1.41|
71886435|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|3.0|7.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.||7.22|3.00|<0.0001
71649351|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.17|0.57||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.57|-2.17|
71649352|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.16|1.64||||||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.64|-1.16|
71649353|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.37|0.35||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||0.35|-2.37|
71649354|NCT02725411|142816266|OTHER|No formal hypotheses were tested in the study.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-1.35|1.42||||||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ as covariates, and study site as a random effect.||1.42|-1.35|
71649355|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|13.0|||||TWO_SIDED|95.0|-0.8|26.3||||||Week 16: \>=30%||26.3|-0.8|
71649356|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.7|||||TWO_SIDED|95.0|-15.8|12.4||||||Week 16: \>=30%||12.4|-15.8|
71649357|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|4.2|32.0||||||Week 16: \>=50%||32.0|4.2|
71649358|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.9|||||TWO_SIDED|95.0|-10.7|16.3||||||Week 16: \>=50%||16.3|-10.7|
71649359|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.9|||||TWO_SIDED|95.0|0.6|20.7||||||Week 16: \>=70%||20.7|0.6|
71649360|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.5|||||TWO_SIDED|95.0|-1.4|18.1||||||Week 16: \>=70%||18.1|-1.4|
71649361|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-4.3|6.5||||||Week 16: \>=90%||6.5|-4.3|
71649362|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|2.1|||||TWO_SIDED|95.0|-3.7|7.8||||||Week 16: \>=90%||7.8|-3.7|
71649363|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.3|25.7||||||Week 24: \>=30%||25.7|-2.3|
71762751|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.9034|TWO_SIDED|90.0|-1.08|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.25|-1.08|0.9034
71649364|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-1.6|||||TWO_SIDED|95.0|-15.9|12.6||||||Week 24: \>=30%||12.6|-15.9|
71649365|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 24: \>=50%||25.8|-2.4|
71649366|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.1|18.9||||||Week 24: \>=50%||18.9|-9.1|
71649367|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|14.1|||||TWO_SIDED|95.0|2.9|24.8||||||Week 24: \>=70%||24.8|2.9|
71649368|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|10.6|||||TWO_SIDED|95.0|-0.2|21.0||||||Week 24: \>=70%||21.0|-0.2|
71649369|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.7|11.4||||||Week 24: \>=90%||11.4|-0.7|
71649370|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 24: \>=90%||8.5|-2.2|
71649371|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.1|30.9||||||Week 40: \>=30%||30.9|3.1|
71649372|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-0.5|||||TWO_SIDED|95.0|-14.8|13.7||||||Week 40: \>=30%||13.7|-14.8|
71649373|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|3.0|31.0||||||Week 40: \>=50%||31.0|3.0|
71649374|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.0|||||TWO_SIDED|95.0|-9.0|18.7||||||Week 40: \>=50%||18.7|-9.0|
71649375|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|17.4|||||TWO_SIDED|95.0|4.6|29.4||||||Week 40: \>=70%||29.4|4.6|
71649376|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.3|||||TWO_SIDED|95.0|-4.5|18.9||||||Week 40: \>=70%||18.9|-4.5|
71649377|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|7.6|||||TWO_SIDED|95.0|1.4|13.5||||||Week 40: \>=90%||13.5|1.4|
71649378|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|5.4|||||TWO_SIDED|95.0|-0.1|10.6||||||Week 40: \>=90%||10.6|-0.1|
71649379|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.4|25.8||||||Week 56: \>=30%||25.8|-2.4|
71649380|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-3.8|||||TWO_SIDED|95.0|-17.9|10.5||||||Week 56: \>=30%||10.5|-17.9|
71649381|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|12.0|||||TWO_SIDED|95.0|-2.5|25.9||||||Week 56: \>=50%||25.9|-2.5|
71649382|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|-2.6|||||TWO_SIDED|95.0|-16.5|11.4||||||Week 56: \>=50%||11.4|-16.5|
71649383|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|18.5|||||TWO_SIDED|95.0|5.6|30.5||||||Week 56: \>=70%||30.5|5.6|
71649384|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.4|||||TWO_SIDED|95.0|-3.6|20.0||||||Week 56: \>=70%||20.0|-3.6|
71649385|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|8.7|||||TWO_SIDED|95.0|1.6|15.4||||||Week 56: \>=90%||15.4|1.6|
71649386|NCT02725411|142816270|OTHER|No formal hypotheses were tested in the study.|Difference in Percentage of Participants|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||Week 56: \>=90%||8.5|-2.2|
71649387|NCT02725411|142816286|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||95% CI of proportion is the Agresti-Coull confidence limit.||4.1|-4.1|
71649388|NCT02725411|142816286|OTHER|No formal hypotheses were tested in the study.|Difference in proportion|3.2|||||TWO_SIDED|95.0|-2.2|8.5||||||95% CI of proportion is the Agresti-Coull confidence limit.||8.5|-2.2|
71649389|NCT02911935|142816312|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.08|TWO_SIDED|95.0|0.95|2.34||unadjusted P-value. The threshold for statistical significance was p = 0.05|Log Rank|||The primary analysis tested the statistical null hypothesis of equal recurrent wheeze rates between the azithromycin and placebo groups.||2.34|0.95|0.08
71649390|NCT02911935|142816312|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||p-value is adjusted for race, parental history of asthma, ever exposed to smoke and ever exposed to pets. The threshold for statistical significance was p = 0.05|Regression, Cox|||||2.29|0.92|0.11
71649391|NCT02911935|142816313|SUPERIORITY||Hazard Ratio (HR)|1.95||||0.12|TWO_SIDED|95.0|0.83|4.61||Unadjusted. The threshold for statistical significance was p = 0.05|Log Rank|||||4.61|0.83|0.12
71649392|NCT02911935|142816314|SUPERIORITY||Rate Ratio|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.62|0.86|0.31
71649393|NCT02911935|142816315|SUPERIORITY||Rate Ratio|1.22||||0.57|TWO_SIDED|95.0|0.6|2.48||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.48|0.6|0.57
71824351|NCT03499600|143152603|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.38|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Linear regressions tested condition effects on session attendance.||||.38
71824352|NCT03499600|143152603|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Analyses tested the moderation of language of service delivery and condition on session attendance.||||.01
71824353|NCT03499600|143152603|SUPERIORITY|||||||0.56|||||||Regression, Linear|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on homework completion. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.56
71824354|NCT03499600|143152603|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analyses tested the moderation effect of language of service delivery and condition on homework completion.||||<.01
71824355|NCT03499600|143152603|SUPERIORITY|||||||0.4|||||||Regression, Logistic|||Power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. Logistic regressions tested condition effects on initial session attendance. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.40
71824356|NCT03499600|143152603|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on initial session attendance.||||.01
71649394|NCT02911935|142816316|SUPERIORITY||Rate Ratio|1.34||||0.38|TWO_SIDED|95.0|0.7|2.57||unadjusted P-value. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||2.57|0.70|0.38
71649395|NCT02911935|142816317|SUPERIORITY||Rate Ratio|0.92||||0.56|TWO_SIDED|95.0|0.7|1.22||Unadjusted. The threshold for statistical significance was p = 0.05|Negative Binomial Regression Analysis|||||1.22|0.7|0.56
71649396|NCT04979858|142816362|OTHER|The statistical analysis involved the use of a single-factor ANOVA test to assess the importance of the various factors associated with the design of the Focal Mask (the Treatment) that would impact its performance in reducing the spread of COVID-19, which is caused by the SARS-CoV-2 virus. The Bonferroni t-test was conducted post hoc to assess the statistical significance of the various factors.|||||<|0.01|||||||ANOVA|||||||<0.01
71649397|NCT02418754|142816381|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.58||||0.2052|TWO_SIDED|95.0|-4.37|1.22||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||1.22|-4.37|0.2052
71649398|NCT02418754|142816381|SUPERIORITY|Analysis was performed using ANCOVA model with baseline measurements as covariate and treatment group, baseline angiographic choroidal neovascularization (CNV) subtype (predominantly or minimally classic versus occult versus occult with no classic lesions) as fixed factors.|Least Squares (LS) Mean Difference|-1.7||||0.0982|TWO_SIDED|95.0|-4.0|0.61||Threshold for significance at 0.025 level.|ANCOVA|||To control for the family-wise type I error rate of 5%, for each of the 2 REGN2176-3 groups the 2-sided hypothesis comparing REGN2176-3 (1 mg: 2 mg) vs. Intravitreal Aflibercept Injection (IAI) 2 mg was tested at a significance level of α = 2.5%.||0.61|-4.00|0.0982
71649399|NCT04974580|142816407|SUPERIORITY||Odds Ratio (OR)|1.3||||0.14|TWO_SIDED|95.0|0.91|1.84||A priori threshold was 0.10|Regression, Logistic||Reported OR is NRT receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving NRT.|Comparison of NRT vs. no-NRT in model adjusted for receipt of digital component||1.84|0.91|0.14
71649400|NCT04974580|142816407|SUPERIORITY||Odds Ratio (OR)|1.04||||0.84|TWO_SIDED|95.0|0.73|1.47||A priori threshold was 0.10|Regression, Logistic||Reported OR is Digital receipt vs. not, so values \>1 indicate higher odds of abstinence among those receiving the Digital component.|Comparison of Digital vs. no Digital in model adjusted for receipt of NRT component||1.47|0.73|0.84
71649401|NCT00462839|142816412|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.|ANOVA|||Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.||||<0.05
71649402|NCT00462839|142816413|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared, Corrected|||||||0.76
71649403|NCT00462839|142816414|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared, Corrected|||||||0.72
71649404|NCT00462839|142816415|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared, Corrected|||||||0.89
71649405|NCT01493596|142816424|OTHER|Comparison of event rates across dose groups.|percentage|14.3|||||TWO_SIDED||||||||There were a total of 5 non-serious adverse events for an AE rate of 14.3%|Descriptive statistics for evaluation of AEs|Descriptive statistics of adverse events|||
71649406|NCT04784637|142816443|SUPERIORITY|||||||0.064|||||||t-test, 2 sided|||||||0.064
71649407|NCT04784637|142816443|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71649408|NCT04784637|142816444|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71649409|NCT04784637|142816444|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71649410|NCT03919695|142816446|SUPERIORITY||Odds Ratio (OR)|0.29||||0.002|TWO_SIDED|95.0|0.11|0.73|||GEE model specifying a logistic distribu||time x arm effect for the comparison at 6-month follow-up|Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interaction||.73|.11|.002
71649411|NCT03259789|142816455|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.32|-0.74|< 0.0001
71738833|NCT04124705|142990542|NON_INFERIORITY|If the lower limit of the 2-sided 95% confidence interval for stratified response rate difference was greater than the non-inferiority margin, the null hypothesis would be rejected and the noninferiority of Armour Thyroid to levothyroxine would be declared.|Stratified Response Rate Difference|-10.52|||||TWO_SIDED|95.0|-18.65|-2.38|||||The response rate difference (Armour Thyroid group minus Levothyroxine group) and the 95% confidence interval were calculated using the Mantel-Haenszel-weighted method with the age group (age \< 65 years or ≥ 65 years) as a stratification factor.|The null hypothesis was that Armour Thyroid would be inferior to levothyroxine for titration TSH response. The non-inferiority hypothesis test was performed at a 1-sided 2.5% level of significance.||-2.38|-18.65|
71649412|NCT03259789|142816457|SUPERIORITY||Difference of LS Means|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.83|-0.86|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-0.86|-1.83|< 0.0001
71649413|NCT03259789|142816459|SUPERIORITY||Difference of LS Means|-7.07|||<|0.0001|TWO_SIDED|95.0|-9.83|-4.32|||Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-4.32|-9.83|< 0.0001
71649414|NCT03259789|142816460|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0014|TWO_SIDED|95.0|1.7|12.95||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 6 was calculated as the odds ratio of bexagliflozin group over placebo group.||12.95|1.70|0.0014
71649415|NCT03259789|142816460|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0001|TWO_SIDED|95.0|1.96|8.92||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 12 was calculated as the odds ratio of bexagliflozin group over placebo group.||8.92|1.96|0.0001
71649416|NCT03259789|142816460|SUPERIORITY||Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|95.0|1.31|5.04||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 18 was calculated as the odds ratio of bexagliflozin group over placebo group.||5.04|1.31|0.0030
71649417|NCT03259789|142816460|SUPERIORITY||Odds Ratio (OR)|3.88|||<|0.0001|TWO_SIDED|95.0|1.99|7.58||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates|The odds ratios of bexagliflozin group over the placebo group at each visit will be estimated from LS means based on the model with the corresponding p-values and their two-sided 95% CIs presented.|Odds ratio at Week 24 was calculated as the odds ratio of bexagliflozin group over placebo group.||7.58|1.99|< 0.0001
71649418|NCT03259789|142816462|SUPERIORITY||Difference of LS Means|-2.51|||<|0.0001|TWO_SIDED|95.0|-3.45|-1.57|||ANCOVA|ANCOVA analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||||-1.57|-3.45|< 0.0001
71649419|NCT03259789|142816464|SUPERIORITY||Difference of LS Means|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.38||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 6 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.38|-0.74|< 0.0001
71649420|NCT03259789|142816464|SUPERIORITY||Difference of LS Means|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.86|-0.46||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 12 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.46|-0.86|< 0.0001
71649421|NCT03259789|142816464|SUPERIORITY||Difference of LS Means|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 18 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.30|-0.69|< 0.0001
71649422|NCT03259789|142816464|SUPERIORITY||Difference of LS Means|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||P-value is presented based on one-sided statistical tests using a 0.025 level of significance|Mixed-effects repeated measures|Mixed-effects repeated measures analysis includes country, treatment, visit, treatment and baseline HbA1c value as fixed effect covariates||Model-adjusted change from baseline at week 24 was calculated as the difference in LS Mean between bexagliflozin group and placebo group.||-0.32|-0.74|< 0.0001
71649423|NCT02063217|142816472|SUPERIORITY|Mixed linear models|Mean Difference (Net)|17.0||||0.07|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean (standard error), units = %. 17(7.2) increase in overnight amyloid-beta 40 concentrations over waking baseline between the sleep deprivation group and controls.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||0.07
71649424|NCT02063217|142816472|SUPERIORITY|Mixed linear models|Mean Difference (Net)|7.0||||1|TWO_SIDED|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean= 7%, standard error = 7.6%. 7% increase in overnight amyloid beta 40 concentrations over the waking baseline between the sleep induction group and control group.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.||||1.0
71649425|NCT02416934|142816492|SUPERIORITY||Mean Difference (Final Values)|-1.5392|STANDARD_ERROR_OF_MEAN|0.7176||0.036|TWO_SIDED|95.0|-2.9761|-0.1022|||t-test, 2 sided|||Comparing DSQ between Dexamethasone and Saline at Day 1 post-op||-.1022|-2.9761|0.036
71649426|NCT02416934|142816492|SUPERIORITY||Mean Difference (Final Values)|-0.604|STANDARD_ERROR_OF_MEAN|0.2543|<|0.05|TWO_SIDED|95.0|-1.1151|-0.093|||t-test, 2 sided|||Comparing Bazaz between Dexamethasone and Saline at 6 months post-op||-.0930|-1.1151|<.05
71649427|NCT02416934|142816493|SUPERIORITY||Mean Difference (Final Values)|1.7874|STANDARD_ERROR_OF_MEAN|3.1273|<|0.05|TWO_SIDED|95.0|-4.5153|8.0902|||t-test, 2 sided|||Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit||8.0902|-4.5153|<.05
71649428|NCT02416934|142816494|SUPERIORITY|||||||0.375||||||Fisher's Exact Test|Fisher Exact|||||||.375
71649429|NCT02212457|142816537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.53|1.02|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||1.02|0.53|
71649430|NCT02212457|142816537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.94|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.94|0.54|
71649431|NCT02212457|142816537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.85|0.51|
71738834|NCT01973998|142990543|EQUIVALENCE|The primary outcome is time from randomization to a composite outcome of all cause re-hospitalization and all-cause mortality, whichever comes first. The primary analysis will be a log-ranked test and associated Kaplan-Meier plot, unadjusted for any covariates|Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789|<|0.1|TWO_SIDED|10.0|1.175|2.133||Because this is a pilot study the intent is to see if there is a signal that would justify a larger clinical trial. Therefore the significance level has been set to 0.1 and the power has been set at 0.7.|Log Rank|||||2.133|1.175|<0.1
71649432|NCT02212457|142816537|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY\_0\_2 versus rMenB\_0\_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.49|||||TWO_SIDED|95.0|0.37|0.66|||ANCOVA|||Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.||0.66|0.37|
71649433|NCT02293460|142816577|SUPERIORITY|The response rate was tested against the historical response rate of 33.3%.|Responder rate|76.2|||<|0.0001|TWO_SIDED|95.0|60.5|87.9||One-sided test at nominal level of significance alpha = 2.5 %|exact binomial Clopper-Pearson|||"For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows:~H0: pI10E \<= 33.3% H1: pI10E \> 33.3%"||87.9|60.5|<0.0001
71649434|NCT00578968|142816597|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
71649435|NCT00578968|142816598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71649436|NCT00578968|142816599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71649437|NCT00578968|142816600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71649438|NCT00578968|142816601|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||Comparison between the two groups at baseline resting.||||0.13
71649439|NCT00578968|142816601|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Comparison was made between the two groups at baseline peak exercise||||<0.01
71649440|NCT00578968|142816602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71649441|NCT00578968|142816603|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71649442|NCT00578968|142816604|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
71649443|NCT00578968|142816605|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||||||0.01
71649444|NCT00578968|142816606|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
71649445|NCT00578968|142816607|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
71649446|NCT00578968|142816608|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
71649447|NCT00578968|142816609|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||||||0.005
71649448|NCT00578968|142816610|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
71649449|NCT00578968|142816611|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
71649450|NCT00578968|142816612|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||ANOVA|||||||0.60
71649451|NCT00578968|142816613|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANOVA|||||||0.35
71886436|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.05|8.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.||8.06|3.05|<0.0001
71649452|NCT00578968|142816614|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANOVA|||||||0.65
71649453|NCT00578968|142816615|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
71649454|NCT00578968|142816616|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison was made between groups at pretreatment resting time period.||||0.73
71649455|NCT00578968|142816616|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||Comparison was made between groups at pretreatment peak exercise time period.||||0.11
71649456|NCT00578968|142816617|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
71649457|NCT00578968|142816618|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||||||0.06
71649458|NCT00578968|142816619|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||ANOVA|||||||0.09
71649459|NCT00578968|142816620|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71649460|NCT00578968|142816621|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71649461|NCT00578968|142816622|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANOVA|||||||0.19
71649462|NCT00578968|142816623|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
71649463|NCT00578968|142816624|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71649464|NCT00603564|142816625|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||endpoint was analyzed in terms of time by comparison of mean +- SD||||<0.001
71649465|NCT00603564|142816626|SUPERIORITY_OR_OTHER|||||||7e-06||95.0|||||Chi-squared|||||||0.000007
71649466|NCT01196117|142816638|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||||||0.0009
71649467|NCT01196117|142816639|SUPERIORITY|||||||0.8938|||||||Wilcoxon (Mann-Whitney)|||||||0.8938
71649468|NCT01196117|142816640|SUPERIORITY||||||<|0.014|||||||Wilcoxon (Mann-Whitney)|||||||<0.014
71649469|NCT01196117|142816641|SUPERIORITY||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|||||||<0.0200
71649470|NCT01196117|142816642|SUPERIORITY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||||||0.1321
71649471|NCT01196117|142816643|SUPERIORITY||||||<|0.249|||||||Wilcoxon (Mann-Whitney)|||||||<0.2490
71649472|NCT01196117|142816644|SUPERIORITY|||||||0.5139|||||||Wilcoxon (Mann-Whitney)|||||||0.5139
71649473|NCT01196117|142816645|SUPERIORITY|||||||0.0597|||||||Wilcoxon (Mann-Whitney)|||||||0.0597
71649474|NCT01196117|142816646|SUPERIORITY|||||||0.2134|||||||Wilcoxon (Mann-Whitney)|||||||0.2134
71649475|NCT03239496|142816648|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 1 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71649476|NCT03239496|142816649|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71649477|NCT03239496|142816650|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71649478|NCT03239496|142816651|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
71649479|NCT03239496|142816652|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.0001
71649480|NCT03239496|142816653|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71649481|NCT03239496|142816654|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71649482|NCT03239496|142816655|NON_INFERIORITY|All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.||||||0.05|||||||t-test, 2 sided|||The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.||||0.05
71649483|NCT00676650|142816662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.1678|TWO_SIDED|95.0|0.762|1.097||1-sided p-value from the stratified log-rank test|Log Rank||Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.|||1.097|0.762|0.1678
71649484|NCT00676650|142816663|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725|||<|0.001|TWO_SIDED|95.0|0.591|0.89||1-sided p-value from the stratified log-rank test.|Log Rank||Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.|||0.890|0.591|<0.001
71649485|NCT00676650|142816664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.561||||0.04|TWO_SIDED|95.0|1.0|19.0||p-value from 2-sided Fisher's Exact test.|Fisher Exact|||||19.0|1.0|0.040
71649486|NCT00683592|142816671|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-2.5||||0.009|TWO_SIDED|95.0|-4.4|-0.6|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline MADRS total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.6|-4.4|0.009
71649487|NCT00683592|142816672|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.6||||0.026|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-D 17 total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.2|-3.1|0.026
71649488|NCT00683592|142816673|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Improve|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||The model was an analysis of variance (ANOVA), with terms for treatment group and center. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-0.5|0.004
71649489|NCT00683592|142816674|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean Change|-1.2||||0.037|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-A total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.||-0.1|-2.4|0.037
71649490|NCT00683592|142816675|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.134||||0.002|TWO_SIDED|95.0|0.047|0.221|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS response rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.221|0.047|0.002
71649491|NCT00683592|142816676|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.066|TWO_SIDED|95.0|-0.008|0.147|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS remission rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.||0.147|-0.008|0.066
71886437|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.0001|TWO_SIDED|95.0|3.18|8.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.||8.96|3.18|<0.0001
71649492|NCT01067521|142816741|SUPERIORITY||Risk Ratio (RR)|0.656|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.539|0.799||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|"Relapses were estimated by a baseline-adjusted, Negative Binomial Regression with an offset based on the log of subject's exposure to treatment. The model included the following covariates: - Baseline EDSS score. - Log of the prior 2-year number of relapses. - Volume of T2 lesions at baseliner. - Status of Gd-enhancing T1 activity at baseline (=0 no Gd-enhancing T1 at baseline; =1 at least one Gd-enhancing T1 at baseline). - CGR."||0.799|0.539|<0.0001
71649493|NCT01067521|142816742|SUPERIORITY||Risk Ratio (RR)|0.653|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|0.546|0.78||The overall significance level for this study is 5%|Negative binomial regression||GA 40 mg vs. placebo|Negative binomial regression||0.780|0.546|<.0001
71649494|NCT01067521|142816743|SUPERIORITY||Risk Ratio (RR)|0.552|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.436|0.699||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|||0.699|0.436|<0.0001
71649495|NCT01067521|142816744|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.048||0.2058|TWO_SIDED|95.0|-0.154|0.033||The overall significance level for this study is 5%|ANCOVA||GA 40 mg vs Placebo|||0.033|-0.154|0.2058
71762752|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.68||||0.3391|TWO_SIDED|90.0|-1.85|0.49|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.49|-1.85|0.3391
71649496|NCT01067521|142816745|SUPERIORITY||Risk Ratio (RR)|0.8332|STANDARD_ERROR_OF_MEAN|0.0744||0.0409|TWO_SIDED|95.0|0.6995|0.9925||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Entire Study The Negative Binomial Regression model covariates: • treatment group • PCBL (Placebo-Controlled Baseline) Kurtzke's Expanded Disability Status Scale (EDSS) score as 1 degree of freedom variable • Log of the # of relapses in the 2 years prior to PCBL • Volume of T2 lesions at PCBL • Status of Gd-enhancing T1 lesion activity at PCBL (=0 if no Gd-enhancing T1 lesions at PCBL; =1 if at least one Gd-enhancing T1 lesion at PCBL) • Country or Geographical Region (CGR)||0.9925|0.6995|0.0409
71649497|NCT01067521|142816746|SUPERIORITY||Risk Ratio (RR)|0.736|STANDARD_ERROR_OF_MEAN|0.081||0.0056|TWO_SIDED|95.0|0.592|0.914||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 6 Negative binomial regression||0.914|0.592|0.0056
71649498|NCT01067521|142816746|SUPERIORITY||Risk Ratio (RR)|0.633|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.524|0.765||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12 Negative binomial regression||0.765|0.524|<0.0001
71649499|NCT01067521|142816746|SUPERIORITY||Risk Ratio (RR)|0.666|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|0.557|0.797||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36 Negative binomial regression||0.797|0.557|<0.0001
71649500|NCT01067521|142816747|SUPERIORITY||Risk Ratio (RR)|0.556|STANDARD_ERROR_OF_MEAN|0.093||0.0005|TWO_SIDED|95.0|0.4|0.773||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Month 6||0.773|0.4|0.0005
71649501|NCT01067521|142816747|SUPERIORITY||Risk Ratio (RR)|0.514|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|0.388|0.679||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12||0.679|0.388|<0.0001
71886438|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.7|||<|0.0001|TWO_SIDED|95.0|3.23|10.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.||10.06|3.23|<0.0001
71649502|NCT01067521|142816747|SUPERIORITY||Risk Ratio (RR)|0.663|STANDARD_ERROR_OF_MEAN|0.086||0.0015|TWO_SIDED|95.0|0.514|0.854||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36||0.854|0.514|0.0015
71649503|NCT01067521|142816748|SUPERIORITY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.041||0.0425|TWO_SIDED|95.0|-0.166|-0.003||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 6||-0.003|-0.166|0.0425
71649504|NCT01067521|142816748|SUPERIORITY||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.05||0.0844|TWO_SIDED|95.0|-0.184|0.012||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 12||0.012|-0.184|0.0844
71649505|NCT01067521|142816748|SUPERIORITY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.106||0.8701|TWO_SIDED|95.0|-0.91|0.225||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 36||0.225|-0.91|0.8701
71649506|NCT00766493|142816750|SUPERIORITY_OR_OTHER||Proportion|0.043|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.021|0.077||Reject H0 if z\<-1.96, or 1-sided p\<0.025.|One Sample Binomial|Significance test was based on a one-sample normal approximation to the binomial test.|The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.|"This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025."||0.077|0.021|0.0001
71649507|NCT00452543|142816756|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.|||||<|0.05||95.0||||Threshold for significance was set a priori at p\<0.05.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
71649508|NCT00452543|142816757|NON_INFERIORITY_OR_EQUIVALENCE|This was a test of non-inferiority between the effects of acamprosate vs. placebo.|||||<|0.05||95.0||||This p \<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.||||<0.05
71649509|NCT00452543|142816758|NON_INFERIORITY_OR_EQUIVALENCE|"This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis is discussed above."|||||<|0.05||95.0||||This p\<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||"Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups."||||<0.05
71886439|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88|||<|0.0001|TWO_SIDED|95.0|4.37|14.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.||14.20|4.37|<0.0001
71649510|NCT01098539|142816771|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test to test whether the difference of LS means (albiglutide - sitagliptin) was less than or equal to the prespecified noninferiority margin of 0.4%.|Median Difference (Final Values)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.49|-0.15|||t-test, 1 sided|||||-0.15|-0.49|<0.0001
71649511|NCT01849458|142816794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.6|STANDARD_DEVIATION|26.0||0.0001|TWO_SIDED|95.0|25.2|40.0|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||40|25.2|0.0001
71649512|NCT01849458|142816795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.7|STANDARD_DEVIATION|23.6||0.0001|TWO_SIDED|95.0|28.7|42.7|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||42.7|28.7|0.0001
71649513|NCT01849458|142816796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|22.2||0.0001|TWO_SIDED|95.0|37.4|50.1|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)||50.1|37.4|0.0001
71649514|NCT01849458|142816797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|20.2||0.0001|TWO_SIDED|95.0|43.2|55.2|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)||55.2|43.2|0.0001
71649515|NCT00721955|142816803|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
71649516|NCT00721955|142816803|SUPERIORITY|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
71649517|NCT00721955|142816804|SUPERIORITY|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
71649518|NCT00721955|142816804|SUPERIORITY||||||<|0.0001||||||-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||<0.0001
71649519|NCT02174276|142816815|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.017||||0.805|TWO_SIDED|95.0|-0.155|0.12|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.120|-0.155|0.805
71824357|NCT03499600|143152603|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. A Logistic regression tested condition effects on completion of first treatment module. Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||.03
71649520|NCT02174276|142816815|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|0.063||||0.37|TWO_SIDED|95.0|-0.075|0.202|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.202|-0.075|0.370
71649521|NCT02174276|142816815|SUPERIORITY|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.056||||0.426|TWO_SIDED|95.0|-0.194|0.082|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.||0.082|-0.194|0.426
71649522|NCT00781079|142816836|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Models included site, age, race, ethnicity.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.5
71649523|NCT00781079|142816837|SUPERIORITY||Z tests if Reg coeff are diff from 0|-0.58||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
71649524|NCT00781079|142816838|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Models included site, age, race, ethnicity. This is the calculated p value.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.||||.05
71649525|NCT00781079|142816839|SUPERIORITY||Z test if reg coeff is diff from 0|0.56||||0.58|TWO_SIDED||||||Regression, Linear|||||||.58
71649526|NCT00781079|142816840|SUPERIORITY||Z test if reg coeff is diff than 0|-0.16||||0.87|TWO_SIDED||||||Regression, Linear|||||||.87
71649527|NCT00781079|142816841|SUPERIORITY||Z test if ref coeff is diff than 0|0.03||||0.98|TWO_SIDED||||||Regression, Linear|||||||.98
71649528|NCT01589601|142816858|SUPERIORITY||Mean Difference (Net)|4.8719||||0.1641|TWO_SIDED|95.0|-2.0289|11.7728|||Mixed Models Analysis|Baseline||||11.7728|-2.0289|0.1641
71649529|NCT01589601|142816858|SUPERIORITY|6 Months|Mean Difference (Net)|9.4938||||0.0299|TWO_SIDED|95.0|0.9406|18.047|||Mixed Models Analysis|||||18.0470|0.9406|0.0299
71649530|NCT01589601|142816859|SUPERIORITY||Mean Difference (Net)|2.7157||||0.5531|TWO_SIDED|95.0|-6.3054|11.7368|||Mixed Models Analysis|Baseline||||11.7368|-6.3054|0.5531
71649531|NCT01589601|142816859|SUPERIORITY||Mean Difference (Net)|11.773||||0.035|TWO_SIDED|95.0|0.8409|22.7052|||Mixed Models Analysis|6 Months||||22.7052|0.8409|0.0350
71649532|NCT01589601|142816860|SUPERIORITY|HADS Anxiety 2 weeks|Mean Difference (Net)|-1.2436||||0.1592|TWO_SIDED|95.0|-2.9817|0.4945|||Mixed Models Analysis|||||0.4945|-2.9817|0.1592
71824358|NCT03499600|143152603|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||Analyses tested the moderation of language of service delivery and condition on completion of first treatment module.||||.03
71649533|NCT01589601|142816860|SUPERIORITY|HADS Anxiety 3 months|Mean Difference (Net)|-0.7946||||0.3657|TWO_SIDED|95.0|-2.5285|0.9393|||Mixed Models Analysis|||||0.9393|-2.5285|0.3657
71649534|NCT01589601|142816860|SUPERIORITY|HADS Anxiety 6 months|Mean Difference (Net)|-1.8269||||0.048|TWO_SIDED|95.0|-3.6375|-0.0164|||Mixed Models Analysis|||||-0.0164|-3.6375|0.0480
71649535|NCT01589601|142816860|SUPERIORITY|HADS Depression at 2 weeks|Mean Difference (Net)|-0.9097||||0.2372|TWO_SIDED|95.0|-2.4253|0.6058|||Mixed Models Analysis|||||0.6058|-2.4253|0.2372
71649536|NCT01589601|142816860|SUPERIORITY|HADS Depression 3 months|Mean Difference (Net)|-0.6592||||0.4237|TWO_SIDED|95.0|-2.2862|0.9678|||Mixed Models Analysis|||||0.9678|-2.2862|0.4237
71649537|NCT01589601|142816860|SUPERIORITY|HADS Depression at 6 months|Mean Difference (Net)|-1.9379||||0.0202|TWO_SIDED|95.0|-3.5672|-0.3085|||Mixed Models Analysis|||||-0.3085|-3.5672|0.0202
71649538|NCT01589601|142816862|SUPERIORITY|FACIT-Sp at 2 weeks|Mean Difference (Net)|0.9413||||0.5857|TWO_SIDED|95.0|-2.4666|4.3493|||Mixed Models Analysis|||||4.3493|-2.4666|0.5857
71649539|NCT01589601|142816862|SUPERIORITY|FACIT-Sp at 3 months|Mean Difference (Net)|1.1174||||0.5655|TWO_SIDED|95.0|-2.7246|4.9594|||Mixed Models Analysis|||||4.9594|-2.7246|0.5655
71649540|NCT01589601|142816862|SUPERIORITY|FACIT-Sp at 6 months|Mean Difference (Net)|3.9809||||0.0271|TWO_SIDED|95.0|0.4581|7.5036|||Mixed Models Analysis|||||7.5036|0.4581|0.0271
71649541|NCT01589601|142816864|SUPERIORITY|All-cause readmissions, Poisson regression with log link and Pearson scale||||||0.56|||||||Poisson regression|||||||0.56
71649542|NCT01589601|142816864|SUPERIORITY|Cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.8|||||||Poisson regression|||||||0.80
71649543|NCT01589601|142816864|SUPERIORITY|Heart failure readmissions, Poisson regression with log link and Pearson scale||||||0.92|||||||Poisson regression|||||||0.92
71649544|NCT01589601|142816864|SUPERIORITY|Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.12|||||||Poisson regression|||||||0.12
71649545|NCT00434837|142816866|SUPERIORITY|||||||0.27|||||||ANOVA|||These results are from the 3-year analysis.||||.27
71649546|NCT00434837|142816867|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 7-year analysis.||||.08
71649547|NCT00434837|142816868|SUPERIORITY|||||||0.22|||||||ANOVA|||These results are from the 15-year analysis.||||.22
71649548|NCT00434837|142816869|SUPERIORITY|||||||0.0078|||||||ANOVA|||These results are from the 15-year analysis.||||.0078
71649549|NCT00434837|142816870|SUPERIORITY|||||||0.0018|||||||ANOVA|||These results are from the 15-year analysis.||||.0018
71649550|NCT00434837|142816871|SUPERIORITY|||||||0.015|||||||ANOVA|||These results are from the 15-year analysis.||||.015
71649551|NCT00434837|142816872|SUPERIORITY|||||||0.003|||||||ANOVA|||These results are from the 15-year analysis.||||.003
71649552|NCT00434837|142816873|SUPERIORITY|||||||0.0006|||||||ANOVA|||These results are from the 15-year analysis.||||.0006
71649553|NCT00434837|142816874|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
71649554|NCT00434837|142816875|SUPERIORITY|||||||0.34|||||||Chi-squared|||These results are from the 15-year analysis.||||.34
71649555|NCT00434837|142816876|SUPERIORITY|||||||0.17|||||||ANOVA|||These results are from the 15-year analysis.||||.17
71824359|NCT03499600|143152604|SUPERIORITY|Due to condition differences all analyses controlled for length of intake assessment (in minutes), site, caregiver race/ethnicity, daily stress, and language of assessment delivery.||||||0.854|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested condition effects on treatment satisfaction.||||.854
71649556|NCT00434837|142816877|SUPERIORITY|||||||0.25|||||||ANOVA|||These results are from the 15-year analysis.||||.25
71649557|NCT00434837|142816878|SUPERIORITY|||||||0.61|||||||ANOVA|||These results are from the 15-year analysis.||||.61
71649558|NCT00434837|142816879|SUPERIORITY|||||||0.15|||||||ANOVA|||These results are from the 15-year analysis.||||.15
71649559|NCT00434837|142816880|SUPERIORITY|||||||0.53|||||||ANOVA|||These results are from the 15-year analysis.||||.53
71649560|NCT00434837|142816881|SUPERIORITY|||||||0.82|||||||ANOVA|||These results are from the 15-year analysis.||||.82
71649561|NCT00434837|142816882|SUPERIORITY|||||||0.03|||||||ANOVA|||These results are from the 15-year analysis.||||.03
71649562|NCT00434837|142816883|SUPERIORITY|||||||0.67|||||||ANOVA|||These results are from the 15-year analysis.||||.67
71649563|NCT00434837|142816885|SUPERIORITY|||||||0.051|||||||ANOVA|||These results are from the 15-year analysis.||||.051
71649564|NCT00434837|142816886|SUPERIORITY|||||||0.14|||||||ANOVA|||These results were from the 15-year analysis.||||.14
71649565|NCT00434837|142816887|SUPERIORITY|||||||0.067|||||||ANOVA|||These results are from the 15-year analysis.||||.067
71649566|NCT00434837|142816888|SUPERIORITY|||||||0.54|||||||ANOVA|||These results were from the 7-year analysis.||||.54
71649567|NCT00434837|142816889|SUPERIORITY|||||||0.08|||||||ANOVA|||These results are from the 15-year analysis.||||.08
71649568|NCT02786927|142816936|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71649569|NCT02786927|142816937|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71649570|NCT02786927|142816938|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71649571|NCT01801917|142816939|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.586||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 2mg group vs. placebo||||
71649572|NCT01801917|142816939|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.022||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 2mg group vs. placebo||||
71649573|NCT01801917|142816939|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.963||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 10mg group vs. placebo||||
71649574|NCT01801917|142816939|SUPERIORITY_OR_OTHER_LEGACY||Bayesian|0.837||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 10mg group vs. placebo||||
71649575|NCT04381481|142816958|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
71649576|NCT04381481|142816959|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||snacks with warning compared to control snack||||<0.001
71649577|NCT04381481|142816960|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
71649578|NCT04381481|142816961|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.001
71649579|NCT04381481|142816962|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||Beverages with claim compared to control beverage||||<0.01
71649580|NCT04381481|142816963|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71649581|NCT04381481|142816964|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71649582|NCT04381481|142816965|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71738835|NCT01973998|142990543|SUPERIORITY||Hazard Ratio (HR)|1.654|STANDARD_DEVIATION|0.4789||0.1|TWO_SIDED|10.0|1.175|2.133|||Log Rank|||A total of 100 patients is required in a 2 treatment parallel-design study. There is a 70% probability that the study will detect a treatment difference at a 2-sided 10% significance level, if the true hazard ratio is 1.654. This is based on the assumption that the accrual period will be 36 months and the follow up period will be 6 months and the median time to event is 8 months. The total number of events will be 73.||2.133|1.175|0.1
71824360|NCT03499600|143152605|SUPERIORITY|||||||0.319|||||||Regression, Linear|||A power analysis assuming an alpha level = 0.05, beta = 0.2, and power = 0.8, identified a sample ≥82 participants was needed to identify small-to-medium effects (i.e., OR\~2.5).Intent-to-treat analyses were employed. linear regressions tested change in ECBI score from baseline to post treatment.||||.319
71649583|NCT04381481|142816966|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71649584|NCT04381481|142816967|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Logistic|||beverages with claim compared to control beverage||||<0.01
71649585|NCT04381481|142816968|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.01
71649586|NCT04381481|142816969|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71649587|NCT04381481|142816970|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71649588|NCT04381481|142816971|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||beverages with claim compared to control beverage||||<0.001
71649589|NCT04381481|142816972|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649590|NCT04381481|142816973|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71824361|NCT03425539|143152617|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and enzyme replacement therapy (ERT) treatment status), and the treatment group.|LS Mean difference vs. placebo|0.42||||0.3189|TWO_SIDED|95.0|-0.4|1.23|||ANCOVA|||||1.23|-0.4|0.3189
71649591|NCT04381481|142816974|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649592|NCT04381481|142816975|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649593|NCT04381481|142816976|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649594|NCT04381481|142816977|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649595|NCT04381481|142816978|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649596|NCT04381481|142816979|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649597|NCT04381481|142816980|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649598|NCT04381481|142816981|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649599|NCT04381481|142816982|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649600|NCT04381481|142816983|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649601|NCT04381481|142816984|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649602|NCT04381481|142816985|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \< 0.05.|Regression, Linear|||warning snacks compared to control snack||||<0.001
71649603|NCT00127166|142817042|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.25||||0.009||95.0|-5.66|-0.84|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period||||-0.84|-5.66|0.009
71649604|NCT00127166|142817043|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-52.71||||0.006||95.0|-89.76|-15.66|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||-15.66|-89.76|0.006
71649605|NCT00127166|142817044|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.11|||<|0.001||95.0|2.58|5.64|||ANCOVA|Participant, treatment, period \& covariate for FEV1 %-predicted Treatment test is adjusted for period \& FEV1 %-predicted at pre-exercise baseline||||5.64|2.58|<0.001
71649606|NCT00127166|142817045|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.26||||0.035||95.0|1.02|1.55|||Cox Proportional Hazards Model|Model terms: treatment and period|Dispersion not applicable to time to event data|||1.55|1.02|0.035
71649607|NCT00127166|142817046|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.8|||<|0.001||95.0|2.28|5.32|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.||||5.32|2.28|<0.001
71649608|NCT00393705|142817090|SUPERIORITY_OR_OTHER|||||||0.2519||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.2519
71649609|NCT00393705|142817091|SUPERIORITY_OR_OTHER|||||||0.0287||95.0||||P-value for HbA1c \<7%. Additional statistically significant terms from the model below were baseline HbA1c and treatment by lead-in interaction.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0287
71824362|NCT03425539|143152618|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the baseline value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|-873.53|||<|0.0001|TWO_SIDED|95.0|-1097.53|-649.53|||ANCOVA|||||-649.53|-1097.53|<0.0001
71824363|NCT03425539|143152619|OTHER|An ANCOVA was applied to the change from baseline to Month 6 including the terms value, the two stratification factors (sex and ERT treatment status), and the treatment group.|LS Mean difference vs. placebo|0.31||||0.4676|TWO_SIDED|95.0|-0.53|1.16|||ANCOVA|||||1.16|-0.53|0.4676
71824364|NCT03425539|143152620|OTHER||Win ratio|1.0||||0.8986|TWO_SIDED|95.0|0.57|1.89|||ANCOVA|||The p-value was derived from a rank ANCOVA adjusted for the baseline value and stratified by sex and ERT treatment status.||1.89|0.57|0.8986
71649610|NCT00393705|142817091|SUPERIORITY_OR_OTHER|||||||0.0471||95.0||||P-value for HbA1c ≤6.5%. Additional statistically significant term from the model below was baseline HbA1c.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).||||||0.0471
71649611|NCT00393705|142817093|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
71649612|NCT00393705|142817094|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0002
71649613|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||P-value for Fasting.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0129
71649614|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for 2-Hours After Breakfast.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0027
71649615|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.1947||95.0||||P-value for Pre-Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1947
71649616|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.0077||95.0||||P-value for 2-Hours After Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0077
71649617|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.1885||95.0||||P-value for Pre-Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.1885
71649618|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.5525||95.0||||P-value for 2-Hours After Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.5525
71649619|NCT00393705|142817095|SUPERIORITY_OR_OTHER|||||||0.4994||95.0||||P-value for 3:00 A.M.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.4994
71649620|NCT00393705|142817097|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value for Total Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.7230
71649621|NCT00393705|142817097|SUPERIORITY_OR_OTHER|||||||0.0063||95.0||||P-value for Nocturnal Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0063
71649622|NCT00393705|142817097|SUPERIORITY_OR_OTHER|||||||0.8876||95.0||||P-value for Severe Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.8876
71649623|NCT00393705|142817098|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0009
71649624|NCT00393705|142817099|SUPERIORITY_OR_OTHER|||||||0.0056||95.0||||P-value for Week 4|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0056
71649625|NCT00393705|142817099|SUPERIORITY_OR_OTHER|||||||0.0421||95.0||||P-value for Week 12|ANCOVA|Model: Value = Treatment + Lead-in + Treatment\*Lead-in + Visit + Treatment\*Visit + Value at baseline + error.||||||0.0421
71649626|NCT01475487|142817134|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 21 participants per group was required to detect a 40% absolute difference in the complication rate between DP and US guided techniques assuming a 45% complication rate in the DP (control) group and using the Fisher's exact test for the comparison of independent proportions. A total of 23 and 24 participants were recruited in the DP and US group, respectively.|||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||<0.01
71649627|NCT01475487|142817135|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.88||||0.001|TWO_SIDED|95.0|1.39|5.94|||Fisher Exact||Risk of injury ( none-mild vs moderate -severe) for all participants|||5.94|1.39|0.001
71649628|NCT01475487|142817135|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Grade 3-4 comparison of None-mild and moderate-severe||||<0.001
71649629|NCT01475487|142817136|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91||||0.701|TWO_SIDED|95.0|0.12|2.72|||Fisher Exact||This is the risk ratio for 1 vs 2 attempts|||2.72|0.12|0.701
71649630|NCT01475487|142817137|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.6||||0.043|TWO_SIDED|95.0|0.79|39.48|||Fisher Exact|||Comparison for Grade 3-4||39.48|0.79|0.043
71649631|NCT01958060|142817166|SUPERIORITY_OR_OTHER||Slope|1.0604|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|95.0|0.9901|1.1308|||||Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.||1.1308|0.9901|
71649632|NCT01958060|142817168|SUPERIORITY_OR_OTHER||Slope|1.5629|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|1.3426|1.7833|||||Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.||1.7833|1.3426|
71649633|NCT02304406|142817191|OTHER||Odds Ratio (OR)|1.85||||0.1304|TWO_SIDED|95.0|0.8|4.77|||Cochran-Mantel-Haenszel|||||4.77|0.80|0.1304
71649634|NCT02304406|142817192|OTHER|||||||0.6422|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6422
71649635|NCT02304406|142817193|OTHER|||||||0.4524|||||||Cochran-Mantel-Haenszel|||||||0.4524
71739441|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.19|||||TWO_SIDED|95.0|0.95|1.49|||ANOVA|The ANOVA model on the log10 transformation of theconcentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.49|0.95|
71824365|NCT02014558|143152623|OTHER||Slope|0.99|||||TWO_SIDED|90.0|0.788|1.19||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||1.19|0.788|
71649636|NCT02304406|142817194|OTHER|||||||0.901|||||||Cochran-Mantel-Haenszel|||||||0.9010
71649637|NCT02304406|142817195|OTHER|||||||0.9067|||||||Cochran-Mantel-Haenszel|||||||0.9067
71824366|NCT02014558|143152623|OTHER||Slope|1.22|||||TWO_SIDED|90.0|1.0|1.43||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.43|1.00|
71824367|NCT02014558|143152624|OTHER||Slope|0.808|||||TWO_SIDED|90.0|0.629|0.988||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.||0.988|0.629|
71649638|NCT02304406|142817196|OTHER|||||||0.8785|||||||Cochran-Mantel-Haenszel|||||||0.8785
71649639|NCT02304406|142817197|OTHER|||||||0.9231|||||||Cochran-Mantel-Haenszel|||||||0.9231
71649640|NCT02304406|142817198|OTHER|||||||0.978|||||||Cochran-Mantel-Haenszel|||||||0.9780
71649641|NCT02304406|142817199|OTHER|||||||0.1144|||||||Cochran-Mantel-Haenszel|||||||0.1144
71649642|NCT02304406|142817200|OTHER|||||||0.0862|||||||Cochran-Mantel-Haenszel|||||||0.0862
71649643|NCT02304406|142817201|OTHER|||||||0.0294|||||||Cochran-Mantel-Haenszel|||||||0.0294
71649644|NCT02304406|142817202|OTHER|||||||0.6877|||||||Cochran-Mantel-Haenszel|||||||0.6877
71649645|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.97|1.49|||||"The Odds Ratio compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having an open encounter alert in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the trial and adjusting for provider-level clustering.||1.49|0.97|
71649646|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||"The OR compares between having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.59|0.83|
71649647|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.61|1.16|||||"The OR compares between having cold-state priming as an intervention factor in the arm the patient's primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.16|0.61|
71824368|NCT02014558|143152624|OTHER||Slope|1.21|||||TWO_SIDED|90.0|1.02|1.41||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.||1.41|1.02|
71649648|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.64|||||"The OR compares between having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.88|
71649649|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.52|0.98|||||"The OR compares between having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||0.98|0.52|
71649650|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||"The OR compares between having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.64|0.89|
71649651|NCT04284553|142817205|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.19|||||"The OR compares patients having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with a logit link and binary errors, evaluating the association between the intervention factors (i.e., behavioral components) and the primary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across the intervention factors across the study arms, rather than between the study arms.||1.19|0.55|
71649652|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-17.6|21.2|||||"The estimate compares having open encounter as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having open encounter in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.2|-17.6|
71649653|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-41.8|17.5|||||"The estimate compares having boostering as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having boostering in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.5|-41.8|
71649654|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|39.5|||||TWO_SIDED|95.0|11.6|67.4|||||"The estimate compares having cold-state priming as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having cold-state priming in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||67.4|11.6|
71649655|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|-1.74|||||TWO_SIDED|95.0|-30.4|26.9|||||"The estimate compares having simplification as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having simplification in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||26.9|-30.4|
71660976|NCT03970837|142835410|SUPERIORITY||Odds Ratio (OR)|2.55|||<|0.0001|TWO_SIDED|95.0|1.85|3.5|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.50|1.85|<0.0001
71762753|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-1.19||||0.0948|TWO_SIDED|90.0|-2.35|-0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.02|-2.35|0.0948
71649656|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-37.6|17.4|||||"The estimate compares having sign-off approval as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having sign-off approval in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||17.4|-37.6|
71649657|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|-24.1|32.5|||||"The estimate compares having pre-commitment as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having pre-commitment in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||32.5|-24.1|
71649658|NCT04284553|142817207|SUPERIORITY||Mean Difference (Final Values)|-12.0|||||TWO_SIDED|95.0|-45.5|21.5|||||"The estimate compares having risk framing as an intervention factor in the arm the patients' primary care providers were assigned to vs. all others not having risk framing in the arm they were assigned to."|Outcomes were evaluated using generalized linear mixed models with an identity link and normally-distributed errors, evaluating the association between the intervention factors (i.e., behavioral components) and secondary outcome, pooling across both stages of the 2-stage Atrius adaptive trial and adjusting for provider-level clustering. As noted in our Study Protocol and pre-specified, the analyses are conducted across intervention factors across study arms, rather than between the study arms.||21.5|-45.5|
71649659|NCT02339415|142817210|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.26|TWO_SIDED|95.0|-0.06|0.21|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||0.21|-0.06|0.26
71649660|NCT02339415|142817211|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.88|-0.2|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.|||-0.20|-0.88|0.002
71649661|NCT00003404|142817213|OTHER||rate of occurance|0.35|||||TWO_SIDED|95.0|0.0|8.0|||||The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.|||8|0|
71649662|NCT01503333|142817256|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at post-intervention. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at post-intervention.|parameter estimate|-0.08||||0.207|TWO_SIDED|95.0|-0.21|0.05|||Mixed Models Analysis|||Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).||0.05|-0.21|.207
71649663|NCT01503333|142817257|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on CV fitness according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline CV fitness, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|0.03|0.36|||Mixed Models Analysis|||Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.||0.36|0.03|.018
71649664|NCT01503333|142817258|OTHER|Linear mixed models were used to analyze intervention effect on BMI-z according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models for BMI-z included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline BMI-z, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.191|TWO_SIDED|95.0|-0.05|0.01|||Mixed Models Analysis|||Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.||0.01|-0.05|.191
71660977|NCT03970837|142835410|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.66|7.9|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||7.90|3.66|<0.0001
71824369|NCT02014558|143152662|OTHER||Geometric LS Mean Ratio|109.46|||||TWO_SIDED|90.0|49.82|240.48||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||240.48|49.82|
71886440|NCT00848354|143293317|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.73|||<|0.0001|TWO_SIDED|95.0|3.4|9.65||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.||9.65|3.40|<0.0001
71824370|NCT02014558|143152663|OTHER||Geometric LS Mean Ratio|149.9||||||90.0|74.88|300.06||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||300.06|74.88|
71649665|NCT01503333|142817259|EQUIVALENCE|Linear mixed models were used to analyze intervention effect on % body fat according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline % body fat, age, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and year cohort.|parameter estimate|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|-0.64|-0.1|||Mixed Models Analysis|||Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.||-0.10|-0.64|.007
71649666|NCT01503333|142817260|EQUIVALENCE|Linear mixed-effect models were applied to examine the intervention effect on MVPA at 9-month follow up. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at follow up.|parameter estimate|-0.09||||0.118|TWO_SIDED|95.0|-0.21|0.02|||Mixed Models Analysis|||||0.02|-0.21|.118
71649667|NCT01503333|142817261|OTHER||parameter estimate|-0.97|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p\>.05.26.||||
71649668|NCT01503333|142817262|OTHER||parameter estimate|2.9|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
71649669|NCT01503333|142817263|OTHER||parameter estimate|0.47|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
71649670|NCT01503333|142817264|OTHER||parameter estimate|30.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
71649671|NCT01503333|142817265|OTHER||parameter estimate|24.48|||<|0.001|TWO_SIDED||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||<.001
71649672|NCT01503333|142817266|OTHER||parameter estimate|3.19|||||TWO_SIDED|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar||||
71649673|NCT00996437|142817304|SUPERIORITY_OR_OTHER||Treatment Difference in Cumulative Prob|4.0||||0.37|TWO_SIDED|95.0|-4.0|13.0|||Log Rank|After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.||The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.||13|-4|0.37
71649674|NCT00996437|142817305|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.|Fisher Exact|||||||0.01
71649675|NCT00996437|142817306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.05|TWO_SIDED|95.0|1.03|2.3|||Log Rank|||||2.30|1.03|0.05
71824371|NCT02014558|143152664|OTHER||Geometric LS Mean Ratio|111.64|||||TWO_SIDED|90.0|69.54|179.25||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||179.25|69.54|
71649676|NCT00996437|142817307|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value corresponds to the 12 week visit treatment comparison.|GLM with GEE method|Number of subjects with baseline OCT ss=0 and OCT ss\>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.||Signal strength was analyzed as a composite outcome defined as OCT signal strength \> = and no vitrectomy vs. OCT signal strength = 0.||||0.87
71649677|NCT00996437|142817308|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value corresponds to the 12 week visit treatment comparison.|Mixed Models Analysis|Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.||||||.04
71649678|NCT00996437|142817310|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value corresponds with the 12 week visit treatment comparison|Fisher Exact|At the each time point, treatment comparison analysis was performed using a Fisher Exact test.||||||.023
71649679|NCT00996437|142817311|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Fisher Exact|At each time point, treatment comparison analysis was performed using a Fisher Exact Test.||||||0.27
71649680|NCT04443569|142817312|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Post-Op Day 1||||0.3
71649681|NCT04443569|142817312|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Post-Op Day 2||||0.9
71649682|NCT04443569|142817312|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Post-Op Day 3||||0.07
71649683|NCT04443569|142817312|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Post-Op Day 4||||0.09
71649684|NCT04443569|142817313|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71649685|NCT03653026|142817363|SUPERIORITY||Adjusted Response Rate Difference|29.0|||<|0.001|TWO_SIDED|95.0|23.2|34.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||34.7|23.2|<0.001
71649686|NCT03653026|142817364|SUPERIORITY||Adjusted Response Rate Difference|35.1|||<|0.001|TWO_SIDED|95.0|28.6|41.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||41.6|28.6|<0.001
71649687|NCT03653026|142817365|SUPERIORITY||Adjusted Response Rate Difference|15.9|||<|0.001|TWO_SIDED|95.0|11.4|20.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||20.3|11.4|<0.001
71649688|NCT03653026|142817366|SUPERIORITY||Adjusted Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|41.7|57.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||57.1|41.7|<0.001
71649689|NCT03653026|142817367|SUPERIORITY||Adjusted Response Rate Difference|37.0|||<|0.001|TWO_SIDED|95.0|28.8|45.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||45.1|28.8|<0.001
71649690|NCT03653026|142817368|SUPERIORITY||Adjusted Response Rate Difference|30.1|||<|0.001|TWO_SIDED|95.0|24.1|36.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - placebo|||36.2|24.1|<0.001
71649691|NCT03653026|142817369|SUPERIORITY||Adjusted Response Rate Difference|27.1|||<|0.001|TWO_SIDED|95.0|19.0|35.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (\<= 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||35.3|19.0|<0.001
71649692|NCT03653026|142817370|SUPERIORITY||Adjusted Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|20.9|37.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||37.4|20.9|<0.001
71649693|NCT03653026|142817371|SUPERIORITY||Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.8|46.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||46.1|29.8|<0.001
71649694|NCT03653026|142817372|SUPERIORITY||Least Squares (LS) Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|24.98|37.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||37.36|24.98|<0.001
71649695|NCT03653026|142817373|SUPERIORITY||Adjusted Response Rate Difference|11.3|||<|0.001|TWO_SIDED|95.0|7.2|15.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Adjusted for Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR).|Difference = Upadacitinib 45 mg - Placebo|||15.3|7.2|<0.001
71649696|NCT03653026|142817374|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|4.19|7.73||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|||7.73|4.19|<0.001
71649697|NCT01729026|142817423|SUPERIORITY_OR_OTHER_LEGACY||Effect size (Cohen's d)|-0.75||||0.141|TWO_SIDED|95.0|-1.85|0.35||Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.20 points on the PCL-5 compared to 7.77 points in the Wait-list group.|Mixed effects regression models|||The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.||0.35|-1.85|0.141
71649698|NCT01729026|142817424|SUPERIORITY||effect size (Cohen's d)|0.0||||0.982|TWO_SIDED||||||effect size (Cohen's d)|||||||0.982
71649699|NCT01729026|142817425|SUPERIORITY||effect size (Cohen's d)|-0.5||||0.16|TWO_SIDED||||||effect size (Cohen's d)|||||||0.160
71649700|NCT01729026|142817426|SUPERIORITY||effect size (Cohen's d)|-1.36||||0.015|TWO_SIDED|95.0|-2.49|-0.23|||effect size (Cohen's d)|||||-0.23|-2.49|0.015
71649701|NCT01729026|142817427|SUPERIORITY||effect size (Cohen's d)|0.2||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71649702|NCT01729026|142817428|SUPERIORITY||mixed effects regression models|-1.41||||0.01|TWO_SIDED|95.0|-2.5|-0.31|||effect size (Cohen's d)|||||-0.31|-2.50|0.010
71649703|NCT01729026|142817429|SUPERIORITY|||||||0.13|||||||Fisher Exact|||||||0.13
71649704|NCT01729026|142817430|SUPERIORITY||effect size (Cohen's d)|0.9||||0.188|TWO_SIDED||||||effect size (Cohen's d)|||||||0.188
71649705|NCT01729026|142817432|SUPERIORITY||effect size (Cohen's d)|1.2||||0.031|TWO_SIDED||||||mixed effects regression models|||||||0.031
71649706|NCT01729026|142817433|SUPERIORITY||effect size (Cohen's d)|0.3||||0.541|TWO_SIDED|95.0|-0.8|1.4|||effect size (Cohen's d)|||||1.40|-0.80|0.541
71649707|NCT01729026|142817434|SUPERIORITY||effect size (Cohen's d)|0.6||||0.139|TWO_SIDED||||||effect size (Cohen's d)|||Please note that a minus number indicates an increase in pain ratings.||||0.139
71649708|NCT01573533|142817485|SUPERIORITY|||||||0.49|||||||ANOVA|||Baseline vs 12 months||||0.49
71649709|NCT01573533|142817486|SUPERIORITY|||||||0.41|||||||ANOVA|||Baseline vs 12 months||||0.41
71649710|NCT01573533|142817487|SUPERIORITY|||||||0.06|||||||ANOVA|||Baseline vs 12 months||||0.06
71649711|NCT00979212|142817499|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||One-sided test at significance level of 0.05|Fisher Exact|||Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR \> 1, where odds ratio (OR)= \[p2\*(1- p1)\]/ \[p1\*(1- p2)\], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher's exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.||||0.96
71649712|NCT04269993|142817507|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
71649713|NCT01294449|142817547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.37|TWO_SIDED|95.0|0.67|1.161|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D group over the hazard rate of mortality in the ICD group. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.||1.161|0.670|0.370
71649714|NCT01294449|142817547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.028|TWO_SIDED|95.0|0.484|0.96|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D arm over the hazard rate of mortality in the ICD arm. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)||0.960|0.484|0.028
71649715|NCT00420095|142817575|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.~Pre-defined non-inferiority margin of 0.3%."|Mean Difference (Net)|-0.05||||0.497||95.0|-0.2|0.1|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.||Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.||0.10|-0.20|0.497
71649716|NCT00420095|142817576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.497||95.0|-0.1|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.10|0.497
71649717|NCT00420095|142817577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.419||95.0|-0.48|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.20|-0.48|0.419
71649718|NCT00420095|142817578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.741||95.0|-1.09|0.78||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.78|-1.09|0.741
71649719|NCT00420095|142817579|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||P-value for the HbA1c Percentage Criteria (7%)|Fisher Exact|||||||0.644
71649720|NCT00420095|142817579|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||P-value for the HbA1c Percentage Criteria (6.5%)|Fisher Exact|||||||0.672
71649721|NCT00420095|142817581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.67||95.0|-0.16|0.11||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means||||0.11|-0.16|0.670
71649722|NCT01634854|142817586|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71649723|NCT03460990|142817615|SUPERIORITY||Least Squares (LS) Mean Difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.5|||Mixed-effects model for repeated measure|||||12.5|7.4|< 0.0001
71649724|NCT03460990|142817616|SUPERIORITY||LS Mean Difference|-48.7|||<|0.0001|TWO_SIDED|95.0|-53.9|-43.5|||Mixed-effects model for repeated measure|||||-43.5|-53.9|<0.0001
71649725|NCT03460990|142817617|SUPERIORITY||LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|8.8|18.3|||Mixed-effects model for repeated measure|||||18.3|8.8|<0.0001
71649726|NCT01435824|142817622|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.1|||||TWO_SIDED|90.0|97.5|115.4||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.4|97.5|
71649727|NCT01435824|142817623|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.2|||||TWO_SIDED|90.0|97.5|115.7||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||115.7|97.5|
71649728|NCT01435824|142817624|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|101.3|||||TWO_SIDED|90.0|89.4|114.9||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||114.9|89.4|
71649729|NCT01435824|142817625|EQUIVALENCE|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|107.9|||||TWO_SIDED|90.0|84.5|137.8||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.||137.8|84.5|
71649730|NCT00117806|142817635|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||0.008
71824372|NCT02014558|143152665|OTHER||Geometric LS Mean Ratio|123.47|||||TWO_SIDED|90.0|72.41|210.52||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||210.52|72.41|
71824373|NCT02014558|143152670|OTHER||Geometric LS Mean Ratio|93.96|||||TWO_SIDED|90.0|75.29|117.26||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||117.26|75.29|
71649731|NCT01765751|142817640|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-0.1|5.6|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.6|-0.1|
71649732|NCT01765751|142817640|SUPERIORITY||Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|0.1|5.9|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||5.9|0.1|
71649733|NCT01765751|142817640|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-3.2|2.7|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||2.7|-3.2|
71649734|NCT01765751|142817641|SUPERIORITY||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|1.6|29.7|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||29.7|1.6|
71649735|NCT01765751|142817641|SUPERIORITY||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-3.7|23.3|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||23.3|-3.7|
71649736|NCT01765751|142817641|SUPERIORITY||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-8.6|20.3|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.|||20.3|-8.6|
71649737|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-8.1|0.4|||||Pain Interference - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||0.4|-8.1|
71649738|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|95.0|-2.6|5.6|||||Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||5.6|-2.6|
71649739|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-5.4|||||TWO_SIDED|95.0|-9.8|1.0|||||Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference||1.0|-9.8|
71649740|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-2.2|3.8|||||Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Function||3.8|-2.2|
71649741|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-2.9|3.2|||||Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Funtion||3.2|-2.9|
71649742|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.4|3.7|||||Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population|Physical Function||3.7|-2.4|
71649743|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|1.1|10.5|||||Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||10.5|1.1|
71649744|NCT01765751|142817642|SUPERIORITY||Median Difference (Net)|3.3|||||TWO_SIDED|95.0|-1.5|8.2|||||Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||8.2|-1.5|
71649745|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue||7.3|-2.3|
71649746|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|-0.9|3.5|||||Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||3.5|-0.9|
71649747|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.6|0.9|||||Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||0.9|-3.6|
71649748|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|2.7|||||TWO_SIDED|95.0|0.4|5.0|||||Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance||5.0|0.4|
71649749|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-4.5|3.9|||||Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||3.9|-4.5|
71649750|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.9|5.1|||||Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||5.1|-2.9|
71649751|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.7|2.9|||||Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety||2.9|-5.7|
71762754|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.74||||0.2959|TWO_SIDED|90.0|-1.91|0.43|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.43|-1.91|0.2959
71649752|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-6.7|0.6|||||Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||0.6|-6.7|
71649753|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-4.1|2.6|||||Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||2.6|-4.1|
71649754|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-5.4|1.4|||||Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression||1.4|-5.4|
71649755|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-4.5|4.9|||||Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||4.9|-4.5|
71649756|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-1.8|7.7|||||Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||7.7|-1.8|
71649757|NCT01765751|142817642|SUPERIORITY||Mean Difference (Net)|-2.8|||||TWO_SIDED|95.0|-7.6|2.0|||||Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role||2.0|-7.6|
71649758|NCT03429049|142817648|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.256||0.1904|TWO_SIDED|95.0|-0.84|0.17|||Mixed Models Analysis|||The NRS least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.17|-0.84|0.1904
71649759|NCT03429049|142817649|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.206||0.0257|TWO_SIDED|95.0|-5.07|-0.33|||Mixed Models Analysis|||The WOMAC A least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||-0.33|-5.07|0.0257
71649760|NCT03429049|142817650|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.545||0.0855|TWO_SIDED|95.0|-2.01|0.13|||Mixed Models Analysis|||The WOMAC B least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.13|-2.01|0.0855
71649761|NCT03429049|142817651|SUPERIORITY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.096||0.055|TWO_SIDED|95.0|-15.86|0.26|||Mixed Models Analysis|||The WOMAC C least squares mean difference in change from baseline between treatment arms was analyzed with a mixed model for repeated measures (MMRM). It included terms for treatment, pooled study center, baseline K L grade category for the index knee, baseline BMI category, sex, study week, treatment by visit study week interaction, and baseline average daily pain with walking NPRS (0-10) score as covariates, using an unstructured covariance structure.||0.26|-15.86|0.0550
71649762|NCT02459418|142817680|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|164.96|||||TWO_SIDED|90.0|137.82|197.45||||||A mixed-effects analysis of variance (ANOVA) model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. Least squares (LS) means and 90% confidence intervals (CIs) for treatment differences on log-scale were obtained and back transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||197.45|137.82|
71649763|NCT02459418|142817681|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|123.15|||||TWO_SIDED|90.0|108.12|140.28||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||140.28|108.12|
71649764|NCT02459418|142817682|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-∞) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS mean ratio|133.68|||||TWO_SIDED|90.0|102.42|174.49||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||174.49|102.42|
71649765|NCT02459418|142817683|OTHER||Median Difference (Net)|7.5|||||TWO_SIDED|90.0|4.5|11.5||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median differences and corresponding 90% CIs were calculated using an exact Hodges-Lehmann estimate.||11.5|4.5|
71649766|NCT02459418|142817685|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|163.0|||||TWO_SIDED|90.0|94.0|282.67||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||282.67|94|
71649767|NCT02459418|142817686|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|177.17|||||TWO_SIDED|90.0|125.65|249.81||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.||249.81|125.65|
71649768|NCT02459418|142817687|OTHER||Median Difference (Net)|2.14|||||TWO_SIDED|90.0|-9.91|12.29||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median difference and corresponding 90% CIs were was calculated using an Exact Hodges-Lehmann estimate with an exact confidence interval.||12.29|-9.91|
71649769|NCT01848210|142817702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65||||0.531|TWO_SIDED|95.0|-19.81|10.51|||Regression, Linear|||||10.51|-19.81|0.531
71649770|NCT02327325|142817708|SUPERIORITY||Mean Difference (Final Values)|-2.94||||0.08|TWO_SIDED|95.0|-6.24|0.35|||Mixed Models Analysis|||This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.||0.35|-6.24|0.08
71824374|NCT02014558|143152671|OTHER||Geometric LS Mean Ratio|91.46|||||TWO_SIDED|90.0|74.6|112.12||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||112.12|74.60|
71649771|NCT02327325|142817708|SUPERIORITY||Mean Difference (Final Values)|-3.26||||0.06|TWO_SIDED|95.0|-6.69|0.06|||Mixed Models Analysis|||This is the comparison of the PA \& CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.||0.06|-6.69|0.06
71649772|NCT02327325|142817709|SUPERIORITY||Mean Difference (Net)|-6.11||||0.07|TWO_SIDED|95.0|-12.85|0.64|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||0.64|-12.85|0.07
71649773|NCT02327325|142817709|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.28|TWO_SIDED|95.0|-11.69|3.48|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||3.48|-11.69|0.28
71649774|NCT02327325|142817710|SUPERIORITY||Mean Difference (Final Values)|3.64||||0.097|TWO_SIDED|95.0|-0.69|7.96|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||7.96|-0.69|0.097
71649775|NCT02327325|142817710|SUPERIORITY||Mean Difference (Final Values)|2.91||||0.196|TWO_SIDED|95.0|-1.55|7.39|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||7.39|-1.55|0.196
71649776|NCT02327325|142817711|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.01|TWO_SIDED|95.0|-6.85|-1.34|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||-1.34|-6.85|<0.01
71649777|NCT02327325|142817711|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.17|TWO_SIDED|95.0|-4.85|0.86|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.||0.86|-4.85|0.17
71649778|NCT02327325|142817712|SUPERIORITY||Median Difference (Final Values)|0.16||||0.95|TWO_SIDED|95.0|-4.86|5.19|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.||5.19|-4.86|0.95
71824375|NCT02014558|143152672|OTHER||Geometric LS Mean Ratio|97.71|||||TWO_SIDED|90.0|74.19|128.7||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||128.70|74.19|
71824376|NCT02014558|143152675|OTHER||Geometric LS Mean Ratio|106.42|||||TWO_SIDED|90.0|85.28|132.81||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||132.81|85.28|
71886441|NCT00848354|143293319|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71649779|NCT02327325|142817712|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-7.07|1.07|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.||1.07|-7.07|0.97
71649780|NCT00809965|142817772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based upon the Cox proportional hazards model|||0.97|0.72|0.020
71649781|NCT00809965|142817772|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.028|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based upon the Cox proportional hazards model|||0.98|0.73|0.028
71649782|NCT00809965|142817773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.016|TWO_SIDED|95.0|0.72|0.97|||Log Rank||Based on the Cox proportional hazards model|||0.97|0.72|0.016
71649783|NCT00809965|142817773|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.025|TWO_SIDED|95.0|0.73|0.98|||Log Rank||Based on the Cox proportional hazards model|||0.98|0.73|0.025
71649784|NCT00809965|142817774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Log Rank||Based upon the Cox proportional hazards model|||1.07|0.81|0.320
71649785|NCT00809965|142817774|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.508|TWO_SIDED|95.0|0.83|1.1|||Log Rank||Based upon the Cox proportional hazards model|||1.10|0.83|0.508
71649786|NCT00809965|142817775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.185|TWO_SIDED|95.0|0.8|1.04|||Log Rank||Based upon the Cox proportional hazards model|||1.04|0.80|0.185
71649787|NCT00809965|142817775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.081|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.081
71649788|NCT00809965|142817776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.011|TWO_SIDED|95.0|0.73|0.96|||Log Rank||Based upon the Cox proportional hazards model|||0.96|0.73|0.011
71649789|NCT00809965|142817776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.07|TWO_SIDED|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model|||1.01|0.78|0.070
71649790|NCT00112294|142817828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.2358|TWO_SIDED|95.0|0.761|1.069||Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model, with treatment as the single covariate.|Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that \>=510 events (IRRC progressions/deaths) would lead to \>=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.||1.069|0.761|0.2358
71649791|NCT00112294|142817829|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.675||||0.0066|TWO_SIDED|95.0|1.152|2.436|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||2.436|1.152|0.0066
71649792|NCT00112294|142817830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.265||||0.1501|TWO_SIDED|95.0|0.918|1.741|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||1.741|0.918|0.1501
71649793|NCT00112294|142817833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1685|TWO_SIDED|95.0|0.754|1.051||An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox's proportional hazard model with treatment as the single covariate.|Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that \>= 558 events would lead to at \>=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.||1.051|0.754|0.1685
71649794|NCT00112294|142817834|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Cochran-Mantel-Haenszel|||Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.||||0.26
71649795|NCT01142908|142817847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.93|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||3.1|-2.8|0.93
71649796|NCT01142908|142817848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4||||0.34|TWO_SIDED|95.0|-1.5|4.3|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||4.3|-1.5|0.34
71649797|NCT01142908|142817850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.91|TWO_SIDED|95.0|-2.0|1.8|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||1.8|-2.0|0.91
71649798|NCT01142908|142817851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||2.2|-1.5|0.70
71649799|NCT01142908|142817852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.9|0.3|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-3.9|0.1
71649800|NCT01142908|142817853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.74|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||1.7|-2.4|0.74
71824377|NCT02014558|143152677|OTHER||Geometric LS Mean Ratio|83.93|||||TWO_SIDED|90.0|46.53|151.39||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||151.39|46.53|
71824378|NCT02014558|143152679|OTHER||Geometric LS Mean Ratio|82.84|||||TWO_SIDED|90.0|40.25|170.48||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.||170.48|40.25|
71649801|NCT01142908|142817855|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|-0.03||||0.87|TWO_SIDED|95.0|-0.4|0.3|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.3|-0.4|0.87
71649802|NCT01142908|142817856|SUPERIORITY_OR_OTHER_LEGACY||logit-difference (Net)|0.2||||0.36|TWO_SIDED|95.0|-0.2|0.5|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.5|-0.2|0.36
71649803|NCT01142908|142817858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.9||||0.08|TWO_SIDED|95.0|-10.3|0.6|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.6|-10.3|0.08
71649804|NCT01142908|142817859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.8||||0.79|TWO_SIDED|95.0|-6.6|5.0|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||5.0|-6.6|0.79
71649805|NCT01142908|142817861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.02||||0.83|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.2|0.83
71649806|NCT01142908|142817862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.54|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.||0.2|-0.4|0.54
71649807|NCT01142908|142817864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.29|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months||0.2|-0.6|0.29
71649808|NCT01142908|142817865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.72|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months||0.4|-0.5|0.72
71649809|NCT00309985|142817878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||Log Rank|||The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.||||0.0003
71649810|NCT00309985|142817879|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71649811|NCT00309985|142817880|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71649812|NCT00309985|142817881|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71649813|NCT00309985|142817882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71649814|NCT00309985|142817883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0009
71649815|NCT00309985|142817883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.40
71649816|NCT01186016|142817886|OTHER||||||<|0.01||||||A priori threshold for the P-Value was.05 or less.|ANOVA|||The scores on the Genetic Knowledge Test for both groups between baseline and the end of the educational sessions were analyzed with repeated measures ANOVA.||||<0.01
71649817|NCT01186016|142817887|OTHER|||||||0.44||||||The a priori threshold for statistical significance was a P-Value of .05 or less.|ANOVA|||Data for Self-Efficacy for Quitting/Resisting Smoking were analyzed with repeated measures ANOVA using three time points: baseline, end of the educational sessions, and end of the smoking cessation sessions.||||0.44
71649818|NCT01186016|142817888|OTHER|Nominal data were analyzed with Chi Square.||||||0.88||||||The a priori threshold P-Value for statistical significance was .05 or less.|Chi-squared|||||||.88
71886442|NCT00848354|143293321|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71649819|NCT03222037|142817917|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.5|-0.09|-0.02|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for high lumniance low contrast|Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.||-0.02|-0.09|
71649820|NCT03222037|142817917|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05|Median Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|97.5|-0.06|-0.01|||Linear Mixed Model|Linear mixed model with Kenward and Roger method for denominator degrees of freedom|Mean difference was calculated as Test- SCR. This comparison is for Low luminance high contrast|||-0.01|-0.06|
71649821|NCT03222037|142817918|EQUIVALENCE|Statistical significance is declared if the lower limit of the 95% confidence interval is above 0 or if the upper limit of the 95% confidence interval is below 0.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0066|TWO_SIDED|95.0|0.01|0.08|||Linear Mixed Model|Linear Mixed Model with Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - SCR.|Comparison between the Test and SCR treatments was carried out using least-square mean differences||0.08|0.01|0.0066
71649822|NCT00496262|142817919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9|STANDARD_DEVIATION|4.4|<|0.0001||90.0|||||2-sided, 1-sample t-test||The entire ITT population was used for a conservative analysis of the mean change in MCF. The mean change was set to 0 for any subject with missing MCF data.|This is an open-label study with statistical comparison between MCF pre-infusion and 1 hour post-infusion.||||<0.0001
71649823|NCT04291508|142817953|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.5|||t-test, 2 sided|||||2.5|-1.6|0.65
71649824|NCT04291508|142817953|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.464|TWO_SIDED|95.0|-3.5|7.6|||t-test, 2 sided|||||7.6|-3.5|0.464
71649825|NCT04291508|142817954|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-12.0|3.3|||Chi-squared|||||3.3|-12.0|0.26
71649826|NCT04291508|142817954|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
71649827|NCT04291508|142817955|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.35|TWO_SIDED|95.0|-1.0|2.9|||t-test, 2 sided|||||2.9|-1.0|0.35
71649828|NCT04291508|142817955|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.45|TWO_SIDED|95.0|-3.4|7.6|||t-test, 2 sided|||||7.6|-3.4|0.45
71649829|NCT04291508|142817956|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.9|1.5|||t-test, 2 sided|||||1.5|-1.9|0.83
71649830|NCT04291508|142817956|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.1|TWO_SIDED|95.0|-0.8|8.9|||t-test, 2 sided|||||8.9|-0.8|0.10
71649831|NCT04291508|142817957|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.55|TWO_SIDED|95.0|-1.2|2.4|||t-test, 2 sided|||||2.4|-1.2|0.55
71649832|NCT04291508|142817957|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.18|TWO_SIDED|95.0|-1.6|8.7|||t-test, 2 sided|||||8.7|-1.6|0.18
71649833|NCT04291508|142817958|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.21|TWO_SIDED|95.0|-0.8|3.6|||t-test, 2 sided|||||3.6|-0.8|0.21
71649834|NCT04291508|142817958|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.4|TWO_SIDED|95.0|-3.4|8.5|||t-test, 2 sided|||||8.5|-3.4|0.40
71649835|NCT04291508|142817959|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.23|TWO_SIDED|95.0|-0.8|3.4|||t-test, 2 sided|||||3.4|-0.8|0.23
71649836|NCT04291508|142817959|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.22|TWO_SIDED|95.0|-2.2|9.4|||t-test, 2 sided|||||9.4|-2.2|0.22
71649837|NCT04291508|142817960|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.58|TWO_SIDED|95.0|-1.6|2.8|||t-test, 2 sided|||||2.8|-1.6|0.58
71649838|NCT04291508|142817960|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.13|TWO_SIDED|95.0|-1.4|10.5|||t-test, 2 sided|||||10.5|-1.4|0.13
71649839|NCT04291508|142817961|SUPERIORITY||Risk Difference (RD)|-4.3||||0.26|TWO_SIDED|95.0|-11.8|3.2|||Chi-squared|||||3.2|-11.8|0.26
71649840|NCT04291508|142817961|SUPERIORITY||Risk Difference (RD)|-13.6||||0.31|TWO_SIDED|95.0|-35.8|8.7|||Fisher Exact|||||8.7|-35.8|0.31
71649841|NCT04291508|142817962|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.6|2.2|||t-test, 2 sided|||||2.2|-1.6|0.76
71649842|NCT04291508|142817962|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.78|TWO_SIDED|95.0|-4.9|6.5|||t-test, 2 sided|||||6.5|-4.9|0.78
71649843|NCT04291508|142817963|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.3|1.9|||t-test, 2 sided|||||1.9|-2.3|0.84
71649844|NCT04291508|142817963|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.1|TWO_SIDED|95.0|-0.9|10.0|||t-test, 2 sided|||||10.0|-0.9|0.10
71649845|NCT04291508|142817964|SUPERIORITY||Risk Difference (RD)|-1.3||||0.79|TWO_SIDED|95.0|-10.9|8.3|||Chi-squared|||||8.3|-10.9|0.79
71649846|NCT04291508|142817964|SUPERIORITY||Risk Difference (RD)|4.9||||1|TWO_SIDED|95.0|-17.5|27.3|||Fisher Exact|||||27.3|-17.5|1.00
71649847|NCT04291508|142817965|SUPERIORITY||Risk Difference (RD)|1.7||||0.53|TWO_SIDED|95.0|-3.7|7.2|||Chi-squared|||||7.2|-3.7|0.53
71649848|NCT04291508|142817965|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-17.0|13.0|||Fisher Exact|||||13.0|-17.0|1.00
71649849|NCT04291508|142817966|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.9|0.6|||t-test, 2 sided|||||0.6|-0.9|0.70
71649850|NCT04291508|142817966|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-2.7|2.5|||t-test, 2 sided|||||2.5|-2.7|0.96
71649851|NCT04291508|142817967|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-2.3|7.3|||Fisher Exact|||||7.3|-2.3|1.00
71886443|NCT00848354|143293323|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71649852|NCT04291508|142817968|SUPERIORITY||Risk Difference (RD)|-4.4||||0.31|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||||4.2|-13.1|0.31
71649853|NCT04291508|142817968|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
71649854|NCT04291508|142817969|SUPERIORITY||Risk Difference (RD)|-0.5||||0.9|TWO_SIDED|95.0|-8.5|7.5|||Chi-squared|||||7.5|-8.5|0.90
71649855|NCT04291508|142817969|SUPERIORITY||Risk Difference (RD)|-27.9||||0.02|TWO_SIDED|95.0|-51.7|-4.0|||Chi-squared|||||-4.0|-51.7|0.02
71649856|NCT04291508|142817970|SUPERIORITY||Risk Difference (RD)|-7.3||||0.003|TWO_SIDED|95.0|-12.2|-2.4|||Chi-squared|||||-2.4|-12.2|0.003
71649857|NCT04291508|142817970|SUPERIORITY||Risk Difference (RD)|6.7||||0.52|TWO_SIDED|95.0|-2.3|15.6|||Fisher Exact|||||15.6|-2.3|0.52
71649858|NCT04291508|142817971|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||||0.2|-0.2|0.68
71649859|NCT04291508|142817971|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.7|0.4|||Fisher Exact|||||0.4|-0.7|0.62
71649860|NCT04291508|142817972|SUPERIORITY||Risk Difference (RD)|0.5||||0.9|TWO_SIDED|95.0|-7.8|8.8|||Chi-squared|||||8.8|-7.8|0.90
71649861|NCT04291508|142817972|SUPERIORITY||Risk Difference (RD)|-15.6||||0.2|TWO_SIDED|95.0|-40.1|8.9|||Chi-squared|||||8.9|-40.1|0.2
71649862|NCT04291508|142817973|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.1|1.3|||t-test, 2 sided|||||1.3|-1.1|0.88
71649863|NCT04291508|142817973|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.1|TWO_SIDED|95.0|-0.6|6.6|||t-test, 2 sided|||||6.6|-0.6|0.10
71649864|NCT01362296|142817986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5197|TWO_SIDED|95.0|0.75|1.75||P-value from the stratified log-rank was adjusted for gender (male versus female).|Log Rank||HRs were estimated using a Pike estimator. The HR from the stratified log-rank test was adjusted for gender (male versus female).|||1.75|0.75|0.5197
71649865|NCT02625974|142818006|OTHER|A direct comparison|Difference in cure rate|14.0|||||TWO_SIDED|95.0|3.7|24.2||||||||24.2|3.7|
71649866|NCT02625974|142818007|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.12|||||TWO_SIDED|95.0|1.21|3.45|||||Person-year = 754|||3.45|1.21|
71649867|NCT02625974|142818012|OTHER|Incidence rate and 95% CI of seronegative conversion|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|0.91|4.16|||||Person-year = 379|||4.16|0.91|
71649868|NCT01923311|142818054|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|135.73|||||TWO_SIDED|90.0|116.24|158.49||||||To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||158.49|116.24|
71649869|NCT01923311|142818055|EQUIVALENCE|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|146.68|||||TWO_SIDED|90.0|127.35|168.94||||||To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).||168.94|127.35|
71649870|NCT00381849|142818079|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.||||0.32
71649871|NCT00381849|142818079|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.||||0.23
71649872|NCT00381849|142818079|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.41
71649873|NCT00381849|142818079|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.||||0.32
71649874|NCT00381849|142818080|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.||||0.49
71649875|NCT00381849|142818080|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.||||0.64
71649876|NCT00381849|142818080|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.72
71649877|NCT00381849|142818080|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.||||0.84
71649878|NCT00381849|142818083|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.||||0.69
71649879|NCT00381849|142818083|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.||||0.25
71649880|NCT00381849|142818083|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.||||0.15
71649881|NCT00381849|142818083|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.||||0.20
71649882|NCT00381849|142818084|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.85
71702461|NCT01047501|142921894|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-21.5|||<|0.0001|TWO_SIDED|95.0|-26.7|-16.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-16.2|-26.7|<0.0001
71649883|NCT00381849|142818084|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.63
71649884|NCT00381849|142818084|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline||||0.97
71649885|NCT00381849|142818084|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline||||0.15
71649886|NCT00381849|142818085|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.81
71649887|NCT00381849|142818085|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.78
71649888|NCT00381849|142818085|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline||||0.96
71649889|NCT00381849|142818085|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline||||0.13
71649890|NCT02426541|142818089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.3794|TWO_SIDED|95.0|-2.18|5.54|||ANCOVA|Adjusted for sex and baseline||||5.54|-2.18|0.3794
71649891|NCT02426541|142818090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.5317|TWO_SIDED|95.0|-5.6|2.96|||ANCOVA|Adjusted for sex and baseline||||2.96|-5.60|0.5317
71649892|NCT02426541|142818091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003||||0.9984|TWO_SIDED|95.0|-3.07|3.07|||ANCOVA|Adjusted for sex and baseline||||3.07|-3.07|0.9984
71649893|NCT00745134|142818094|OTHER|||||||0.33|||||||ANOVA|||||||0.33
71649894|NCT00835796|142818123|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|94.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109|94.2|
71649895|NCT00835796|142818124|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.7||||||90.0|94.0|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|94.0|
71649896|NCT00835796|142818125|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.8||||||90.0|94.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|94.5|
71649897|NCT00951093|142818141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P value adjusted for multiple comparisons|Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||<0.001
71649898|NCT00951093|142818142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||0.002
71649899|NCT00951093|142818143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|||||||< 0.001
71649900|NCT00951093|142818144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.020
71649901|NCT00951093|142818145|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||< 0.001
71649902|NCT00951093|142818146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons||||||0.001
71649903|NCT00951093|142818147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Friedman´s test|followed by nonparametric pairwise multiple comparisons||||||< 0.001
71649904|NCT04412057|142818184|SUPERIORITY||Odds Ratio (OR)|2.86||||0.044|TWO_SIDED|90.0|1.04|7.88|||Regression, Logistic|||The sample size provided greater than 80% power to detect a difference of 0.25 in the proportion of subjects alive and free of respiratory failure using a Chi-square exact test at a one-sided significance level of 0.05. This calculation assumed that the proportion alive and free of respiratory failure will be 0.60 in the placebo group and 0.85 in the CERC-002 group.||7.88|1.04|0.0440
71649905|NCT04412057|142818185|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1762|TWO_SIDED|90.0|0.59|6.82|||Regression, Logistic|||The proportion of subjects alive at Day 28/ET in the CERC-002 group was compared to that in the placebo group using logistic regression methods. The logistic regression model included terms for treatment group. Model based point estimate (i.e., odds ratio \[OR\]), 90% confidence interval \[CI\], and one-sided p-value were reported.||6.82|0.59|0.1762
71649906|NCT02156154|142818186|SUPERIORITY||Median Difference (Final Values)|-0.04||||0.29|TWO_SIDED|95.0|-0.18|0.11||significance criterion of P \< .044.|Wilcoxon (Mann-Whitney)||Difference = IV Acetaminophen - Placebo group|A total of 28 patients (5%) were missing monitoring data (14 patients in each group). Values for these patients were obtained using multivariable imputation with 5 imputation data sets. The imputation regression model included all of the baseline, intraoperative, surgical, and postanesthesia care unit variables and all of the secondary outcomes||0.11|-0.18|0.29
71649907|NCT02156154|142818187|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.07|TWO_SIDED|99.4|-0.71|0.15||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.15|-0.71|0.07
71649908|NCT02156154|142818188|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.46|TWO_SIDED|99.4|-0.51|0.29||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|||0.29|-0.51|0.46
71649909|NCT02156154|142818189|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.56|TWO_SIDED|99.4|-0.49|0.76||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.76|-0.49|0.56
71649910|NCT02156154|142818190|SUPERIORITY||Mean Difference (Net)|-0.08||||0.3|TWO_SIDED|99.4|-0.29|0.13||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as differences in means between the study groups, assessed using a 2-sample t test.|||0.13|-0.29|0.30
71649911|NCT02156154|142818191|SUPERIORITY||Ratios of geometric means|0.94||||0.65|TWO_SIDED|99.4|0.63|1.39||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.39|0.63|0.65
71649912|NCT02156154|142818192|SUPERIORITY||Ratios of geometric means|0.86||||0.22|TWO_SIDED|99.4|0.61|1.21|||t-test, 2 sided||Treatment effect data are reported as ratios of geometric means, assessed using a 2-sample t test after logarithmic transformation of outcomes.|||1.21|0.61|0.22
71649913|NCT02156154|142818193|SUPERIORITY||Risk Ratio (RR)|1.13||||0.18|TWO_SIDED|99.4|0.88|1.45||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||Risk ratio = Treatment/Placebo|||1.45|0.88|0.18
71649914|NCT02156154|142818194|SUPERIORITY||Risk Ratio (RR)|0.9||||0.53|TWO_SIDED|99.4|0.57|1.43||Confidence intervals were adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Chi-squared||RR = Treatment/Placebo|||1.43|0.57|0.53
71649915|NCT02156154|142818195|SUPERIORITY||Median Difference (Final Values)|0.0||||0.99|TWO_SIDED|99.4|-0.39|0.36||Adjusted for 8 comparisons using Bonferroni correction (.05/8 = .006), for a significance criterion of P \< .006.|Wilcoxon (Mann-Whitney)||Treatment effect is reported as median difference, estimated using the Hodges-Lehmann estimator of location shift.|||0.36|-0.39|0.99
71649916|NCT02051595|142818196|SUPERIORITY_OR_OTHER||estimate (beta) from mixed model|-0.068|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|-0.098|-0.039||A priori threshold was set to p \< 0.05.|Mixed Models Analysis|Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.|Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).|||-0.039|-0.098|<0.0001
71649917|NCT00407745|142818204|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.198||0.0032|TWO_SIDED|95.0|-0.98|-0.2||Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.|ANCOVA|||"Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors."||-0.20|-0.98|0.0032
71660978|NCT03970837|142835410|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90 mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
71886444|NCT00848354|143293325|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71649918|NCT00407745|142818205|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.255||0.0066|TWO_SIDED|95.0|-1.2|-0.2||Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (\<=0.05).|ANCOVA|ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.20|-1.20|0.0066
71649919|NCT00407745|142818206|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.039|TWO_SIDED|95.0|1.032|3.328||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Regression, Logistic|Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group||3.328|1.032|0.0390
71649920|NCT00407745|142818207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0||||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Cochran-Mantel-Haenszel|Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.||Null hypothesis - The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis - The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.||||0.0006
71649921|NCT00407745|142818208|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.265|<|0.0001|TWO_SIDED|95.0|-1.6|-0.56||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|ANCOVA|ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.56|-1.60|<0.0001
71649922|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.0295|TWO_SIDED|95.0|-0.94|-0.05||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.05|-0.94|0.0295
71649923|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0033|TWO_SIDED|95.0|-1.11|-0.22||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.22|-1.11|0.0033
71649924|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.23||0.0185|TWO_SIDED|95.0|-0.98|-0.09||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.09|-0.98|0.0185
71649925|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.10|0.0040
71649926|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23||0.0004|TWO_SIDED|95.0|-1.26|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.26|0.0004
71702462|NCT01047501|142921894|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.1||||0.0005|TWO_SIDED|95.0|-15.7|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-15.7|0.0005
71649927|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0018|TWO_SIDED|95.0|-1.17|-0.27||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.27|-1.17|0.0018
71649928|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0027|TWO_SIDED|95.0|-1.14|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.14|0.0027
71649929|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.11|-0.21||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.21|-1.11|0.0041
71649930|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.18|-1.09|0.0058
71649931|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0031|TWO_SIDED|95.0|-1.14|-0.23||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.23|-1.14|0.0031
71649932|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.23||0.0076|TWO_SIDED|95.0|-1.08|-0.17||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.17|-1.08|0.0076
71649933|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0328|TWO_SIDED|95.0|-0.95|-0.04||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.04|-0.95|0.0328
71649934|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.02|-0.11||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.11|-1.02|0.0150
71649935|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0048|TWO_SIDED|95.0|-1.11|-0.2||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.20|-1.11|0.0048
71649936|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.15|-0.24||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.24|-1.15|0.0030
71739235|NCT02218008|142991201|SUPERIORITY|The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.|Least Squares Mean Difference|-1.7||||0.076|TWO_SIDED|95.0|-3.6|0.2||ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.|Mixed Models Analysis|||ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.||0.2|-3.6|0.076
71649937|NCT00407745|142818209|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0011|TWO_SIDED|95.0|-1.22|-0.3||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.30|-1.22|0.0011
71649938|NCT00407745|142818210|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.0256|TWO_SIDED|95.0|1.103|4.546||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.||Null hypothesis - The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis - The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.||4.546|1.103|0.0256
71649939|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.23|-0.35||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.35|-1.23|0.0004
71649940|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.43||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.43|-1.31|<0.0001
71649941|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0004|TWO_SIDED|95.0|-1.24|-0.36||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.36|-1.24|0.0004
71649942|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23||0.0008|TWO_SIDED|95.0|-1.2|-0.32||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.32|-1.20|0.0008
71649943|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.38|<0.0001
71649944|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.48||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.48|-1.37|<0.0001
71649945|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.35|<0.0001
71649946|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.35|-0.46||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.46|-1.35|<0.0001
71649947|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.5||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.50|-1.39|<0.0001
71739236|NCT00588354|142991248|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.05||0.159|TWO_SIDED|95.0|-0.52|3.6|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||3.60|-0.52|0.159
71649948|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
71649949|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.39|-0.49||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.49|-1.39|<0.0001
71649950|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.37|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.37|<0.0001
71649951|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.38|-0.47||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.47|-1.38|<0.0001
71649952|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.41|-0.51||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.51|-1.41|<0.0001
71649953|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.53|-0.63||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.63|-1.53|<0.0001
71649954|NCT00407745|142818211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.51|-0.61||Significance was declared if p-value \<=0.05|Mixed Models Analysis|||"Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."||-0.61|-1.51|<0.0001
71649955|NCT00407745|142818212|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.269||0.0438|TWO_SIDED|95.0|-1.08|-0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.02|-1.08|0.0438
71649956|NCT00407745|142818213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.448||0.7103|TWO_SIDED|95.0|-1.06|0.72||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.72|-1.06|0.7103
71649957|NCT00407745|142818213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.0747|TWO_SIDED|95.0|-1.28|0.06||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.06|-1.28|0.0747
71739237|NCT00588354|142991249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.97||0.91|TWO_SIDED|95.0|-1.79|2.01|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.01|-1.79|0.910
71886445|NCT00848354|143293327|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
71886446|NCT00848354|143293327|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||0.0007
71649958|NCT00407745|142818214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.379||0.5689|TWO_SIDED|95.0|-0.97|0.54||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.54|-0.97|0.5689
71649959|NCT00407745|142818214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.322||0.4764|TWO_SIDED|95.0|-0.87|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-0.87|0.4764
71649960|NCT00407745|142818215|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.474||0.3362|TWO_SIDED|95.0|-1.4|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.40|0.3362
71649961|NCT00407745|142818215|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.321||0.3113|TWO_SIDED|95.0|-0.96|0.31||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.31|-0.96|0.3113
71649962|NCT00407745|142818216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.539||0.2721|TWO_SIDED|95.0|-1.67|0.48||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.48|-1.67|0.2721
71649963|NCT00407745|142818216|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.337||0.4906|TWO_SIDED|95.0|-0.43|0.9||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.90|-0.43|0.4906
71649964|NCT00407745|142818217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.472||0.3123|TWO_SIDED|95.0|-1.42|0.46||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.46|-1.42|0.3123
71649965|NCT00407745|142818217|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.368||0.136|TWO_SIDED|95.0|-1.28|0.18||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.18|-1.28|0.1360
71649966|NCT00407745|142818218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.549||0.4257|TWO_SIDED|95.0|-1.53|0.65||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.65|-1.53|0.4257
71649967|NCT00407745|142818218|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.412||0.2005|TWO_SIDED|95.0|-1.34|0.28||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.28|-1.34|0.2005
71739238|NCT00588354|142991250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96|STANDARD_ERROR_OF_MEAN|2.04||0.162|TWO_SIDED|95.0|-1.04|6.96|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.96|-1.04|0.162
71886447|NCT00848354|143293327|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0009
71739239|NCT00588354|142991251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.67|STANDARD_ERROR_OF_MEAN|2.27||0.022|TWO_SIDED|95.0|1.22|10.12|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||10.12|1.22|0.022
71649968|NCT00407745|142818219|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.025||0.1377|TWO_SIDED|95.0|-0.09|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.01|-0.09|0.1377
71649969|NCT00407745|142818220|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.038||0.3312|TWO_SIDED|95.0|-0.11|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.11|0.3312
71649970|NCT00407745|142818221|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.044|TWO_SIDED|95.0|-0.13|0.0||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.00|-0.13|0.0440
71649971|NCT00407745|142818222|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.033||0.137|TWO_SIDED|95.0|-0.12|0.02||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.02|-0.12|0.1370
71649972|NCT00407745|142818223|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.028||0.8911|TWO_SIDED|95.0|-0.06|0.05||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.05|-0.06|0.8911
71649973|NCT00407745|142818224|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.034||0.3731|TWO_SIDED|95.0|-0.1|0.04||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.04|-0.10|0.3731
71649974|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.383||0.3312|TWO_SIDED|95.0|-1.13|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.13|0.3312
71649975|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0976|TWO_SIDED|95.0|-1.37|0.12||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.12|-1.37|0.0976
71649976|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.393||0.0538|TWO_SIDED|95.0|-1.54|0.01||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.01|-1.54|0.0538
71649977|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.389||0.3239|TWO_SIDED|95.0|-1.15|0.38||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.38|-1.15|0.3239
71649978|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.376||0.1912|TWO_SIDED|95.0|-1.23|0.25||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.25|-1.23|0.1912
71739240|NCT00588354|142991252|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.86|STANDARD_ERROR_OF_MEAN|3.28||0.089|TWO_SIDED|95.0|-0.57|12.29|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||12.29|-0.57|0.089
71739241|NCT00588354|142991253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.04|STANDARD_ERROR_OF_MEAN|3.17||0.038|TWO_SIDED|95.0|0.83|13.25|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||13.25|0.83|0.038
71649979|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.353||0.672|TWO_SIDED|95.0|-0.55|0.85||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.85|-0.55|0.6720
71649980|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.33||0.7821|TWO_SIDED|95.0|-0.74|0.56||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.56|-0.74|0.7821
71649981|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.352||0.6851|TWO_SIDED|95.0|-0.84|0.55||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.55|-0.84|0.6851
71649982|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.387||0.361|TWO_SIDED|95.0|-1.12|0.41||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.41|-1.12|0.3610
71649983|NCT00407745|142818225|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.402||0.4915|TWO_SIDED|95.0|-1.07|0.52||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."||0.52|-1.07|0.4915
71649984|NCT00407745|142818226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0536||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.0536
71649985|NCT00407745|142818227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3107||95.0||||p-values are adjusted for baseline score. Significance was declared if p-value \<=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis - The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis - The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.||||0.3107
71649986|NCT00407745|142818228|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|2.182||0.0262|TWO_SIDED|95.0|-9.19|-0.59||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.59|-9.19|0.0262
71649987|NCT00407745|142818229|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.985||0.0041|TWO_SIDED|95.0|-14.55|-2.78||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-2.78|-14.55|0.0041
71738836|NCT04302545|142990549|OTHER|Other Primary outcomes were the extent of injury, operative time, blood loss and proportion of subjects receiving a blood transfusion. Postoperatively, subjects were assessed for secondary outcomes of UTI, micturition problems, and fistula formation during the hospital stay and for the next 3 months. Postoperative micturition problems were feeling of incomplete evacuation, frequency, urgency, urethral and extra-urethral incontinence.|Odds Ratio (OR)|-0.178|||<|0.0001|TWO_SIDED|95.0|-0.261|-0.094||The threshold for statistical significance was \<.05.|Regression, Linear|||"Null Hypothesis: During the cesarean section of women with adhesions of the previous cesarean section that obscure the bladder, the bladder injury rate is not significantly decreased in cystoinflation group compared to the control.~In this study, the bladder injury rate was seven times lesser in cystoinflation group compared to the control, thereby strongly supporting our hypothesis. The power of the study for bladder injury was 0.988, calculated with statistical software G'Power version 3.1."||-.094|-.261|<.0001
71649988|NCT00407745|142818230|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|STANDARD_ERROR_OF_MEAN|3.492||0.0998|TWO_SIDED|95.0|-1.11|12.66||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.66|-1.11|0.0998
71649989|NCT00407745|142818231|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.7|STANDARD_ERROR_OF_MEAN|3.501||0.1048|TWO_SIDED|95.0|-1.2|12.61||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||12.61|-1.20|0.1048
71649990|NCT00407745|142818232|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.417||0.0347|TWO_SIDED|95.0|-9.91|-0.37||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.37|-9.91|0.0347
71649991|NCT00407745|142818233|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.189||0.0436|TWO_SIDED|95.0|0.01|0.76||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.76|0.01|0.0436
71649992|NCT00407745|142818234|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.77||0.2761|TWO_SIDED|95.0|-2.44|8.49||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||8.49|-2.44|0.2761
71649993|NCT00407745|142818235|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81||||0.0024|TWO_SIDED|95.0|1.443|5.491||Significance was declared if p-value \<=0.05|Regression, Logistic|Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.||Null hypothesis - The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis - The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.||5.491|1.443|0.0024
71649994|NCT00407745|142818236|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.433||0.1164|TWO_SIDED|95.0|-1.54|0.17||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||0.17|-1.54|0.1164
71649995|NCT00407745|142818237|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.447||0.0279|TWO_SIDED|95.0|-1.87|-0.11||Significance was declared if p-value \<=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.||-0.11|-1.87|0.0279
71649996|NCT00108082|142818238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.7651||95.0|-1.83|2.49|||ANCOVA|||The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.||2.49|-1.83|0.7651
71649997|NCT00108082|142818238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.1711||95.0|-0.7|3.9|||ANCOVA|||||3.90|-0.70|0.1711
71738837|NCT04302545|142990550|OTHER||Odds Ratio (OR)|-211.776|||<|0.0001|TWO_SIDED|95.0|-290.7|-132.84|||Regression, Linear|||||-132.84|-290.70|<0.0001
71649998|NCT00955552|142818258|NON_INFERIORITY|Non-inferiority test of Ártico vs Cosamin DS® regarding the decrease of pain scale (VAS) in the PP population (N = 86).|||||<|0.05||||||For numeric variables Test -t student or ANOVA will be used. It will be considered statistically significant P-value less than 0,05.|t-test, 1 sided|||||||<0.05
71649999|NCT00412737|142818289|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.283||||0.772|TWO_SIDED|95.0|-2.3|4.1|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.||4.1|-2.3|0.772
71650000|NCT00412737|142818290|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.37||||0.534|TWO_SIDED|95.0|-2.1|4.5|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.5|-2.1|0.534
71650001|NCT00412737|142818291|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.431||||0.381|TWO_SIDED|95.0|-1.7|4.6|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.7|0.381
71650002|NCT00412737|142818292|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.713|||||TWO_SIDED|95.0|-0.6|5.2|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.2|-0.6|
71650003|NCT00412737|142818293|SUPERIORITY_OR_OTHER||Slope|0.858|||||TWO_SIDED|95.0|0.1|5.7|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.7|0.1|
71738838|NCT04302545|142990551|OTHER||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|-3.634|3.634|||Regression, Linear|||Null Hypothsis:Cystoinflation is ineffective to prevent bladder injury in adhesions of previous C-section.The cystoinflation was to be cosidered ineffective if proportion of bladder injury in study group was less than %0% of the control.The power of the study for bladder injury prevention was.988,calculated with statistical software G'Power version3.1.||3.634|-3.634|1
71824379|NCT03006341|143152748|OTHER||C-Statistic|0.81|||||||||||Regression, Logistic|Logistic regression with bleeding history or predisposition as dependent and treatment groups and claims based variables as the independent variables|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
71650004|NCT00412737|142818294|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.372|||||TWO_SIDED|95.0|-1.9|4.6|||||Relative Risk Reduction = (1.0 - Relative Risk).|||4.6|-1.9|
71650005|NCT00412737|142818295|SUPERIORITY_OR_OTHER||Relative Risk Reduction|0.502|||||TWO_SIDED|95.0|-1.4|5.1|||||Relative Risk Reduction = (1.0 - Relative Risk).|||5.1|-1.4|
71650006|NCT00513617|142818318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1254|STANDARD_ERROR_OF_MEAN|0.0705||0.08||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from the Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.080
71650007|NCT00513617|142818318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.098|STANDARD_ERROR_OF_MEAN|0.0713||0.133||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.133
71650008|NCT00513617|142818320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1826|STANDARD_ERROR_OF_MEAN|0.0713||0.915||||||Alpha was set at 0.5|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.915
71650009|NCT00513617|142818320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3582|STANDARD_ERROR_OF_MEAN|4.1047||0.918||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.918
71650010|NCT00513617|142818321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7867|STANDARD_ERROR_OF_MEAN|1.1101||0.015||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.015
71650011|NCT00513617|142818321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5213|STANDARD_ERROR_OF_MEAN|1.1553||0.557||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.||||0.557
71650012|NCT02618382|142818333|SUPERIORITY||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
71886448|NCT00848354|143293327|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
71650013|NCT02618382|142818334|SUPERIORITY||||||<|0.05||||||Paired comparison of hematoma thickness at defined time point means determined by ANOVA for continuous variables.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
71650014|NCT02618382|142818335|OTHER||||||<|0.05||||||The P values for differences among time point means were determined by ANOVA for continuous variables and by chi-squared test for categorical values in grouped mRS scores.|ANOVA|||Nonparametric tests were used for statistical comparison, including the Kruskal-Wallis rank-sum test for multiple groups and the Mann-Whitney U test for 2 groups. P values \<0.05 were considered statistically significant. Data tabulation and analysis were performed using R statistical software version 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).||||<0.05
71650015|NCT03173560|142818350|NON_INFERIORITY|Odd ratio for ORR24W was analyzed along with 90% CI for each treatment arm using Cochran-Mantel-Haenszel (CMH) method, stratified by Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic group and prior programmed cell death protein 1/ programmed cell death protein ligand 1 (PD-1/PD-L1) treatment from IxRS data. Non-inferiority would be claimed if 1-sided P value is \<=0.045 at the final analysis for the non-inferiority test with the non-inferiority margin of the odd ratio =0.76.|Odds Ratio (OR)|0.88||||0.2676|TWO_SIDED|90.0|0.59|1.32|||Cochran-Mantel-Haenszel|||||1.32|0.59|0.2676
71886449|NCT00848354|143293327|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0005
71650016|NCT03173560|142818351|SUPERIORITY|Percentage of participants with intolerable Grade 2 or any Grade \>=Grade 3 TEAEs within 24 weeks was tested using CMH method at 2-sided α=0.05, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment from IxRS data. The treatment difference and 95% CI were also calculated based on asymptotic normal approximation.|Difference|3.2||||0.4763|TWO_SIDED|95.0|-5.5|11.9|||Cochran-Mantel-Haenszel|||||11.9|-5.5|0.4763
71650017|NCT03173560|142818352|OTHER|The hazard ratio and the corresponding 90% CIs were estimated using the Cox regression model with Efron's method for ties, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|90.0|1.08|1.86||||||||1.86|1.08|
71650018|NCT03173560|142818353|OTHER|Odd ratio for ORR was analyzed along with 90% CI for each treatment arm using CMH method stratified by MSKCC prognostic group and PD-1/PD-L1 treatment from IxRS data.|Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.52|1.14||||||||1.14|0.52|
71650019|NCT04254809|142818368|SUPERIORITY||Slope|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.02|-0.25||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regressing scores at one-week follow-up onto scores at baseline.||-0.25|-1.02|.001
71650020|NCT04254809|142818369|SUPERIORITY||Slope|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.99|-0.23||Threshold for significance was p = .05|Regression, Linear||REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-month follow-up onto scores at baseline.||-0.23|-0.99|.002
71650021|NCT04254809|142818370|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.86|-0.05||Threshold for statistical significance was p = .05|Regression, Linear||REST coded as -, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL.|Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-week follow-up onto scores at baseline.||-.05|-0.86|.03
71650022|NCT02795676|142818382|NON_INFERIORITY|Non-inferiority was to be declared if the lower bound of the confidence interval for the treatment difference is above the non-inferiority margin, which was met. No p-value was calculated as this is not relevant for non-inferiority.|Median Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-2.444|1.726|||Regression, Linear|The primary efficacy analysis compared eGFR slope between the treatment arms using a 2-stage model with quantile regression.||||1.726|-2.444|
71650023|NCT02690935|142818417|SUPERIORITY|||||||0.642||||||No adjustment of the p-value|t-test, 2 sided|||H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different||||0.642
71650024|NCT02690935|142818418|SUPERIORITY|||||||0.829||||||No adjustment for multiplicity|t-test, 2 sided|||H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life||||0.829
71650025|NCT03566238|142818440|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|28.23|STANDARD_ERROR_OF_MEAN|9.182||0.0019|TWO_SIDED|95.0|9.83|46.64|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||46.64|9.83|0.0019
71650026|NCT03566238|142818440|SUPERIORITY|"ANCOVA model including treatment, baseline pruritus score at AM and PM, PFIC type, and age category was used for treatment comparisons. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."|LS mean difference|21.71|STANDARD_ERROR_OF_MEAN|9.892||0.0163|TWO_SIDED|95.0|1.87|41.54|||ANCOVA|||Analysis of the Proportion of Positive Pruritus Assessments at Participant Level over the 24-Week Treatment Period - Albireo ObsRO Instrument (AM and PM Scores)||41.54|1.87|0.0163
71738839|NCT04302545|142990552|OTHER||Odds Ratio (OR)|-1.093||||0.001|TWO_SIDED|95.0|-1.708|-0.479|||Regression, Linear|||||-.479|-1.708|.001
71738840|NCT04302545|142990553|OTHER||Odds Ratio (OR)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.226|-0.073|||Regression, Linear|||||-0.073|-0.226|<0.0001
71650027|NCT03566238|142818441|SUPERIORITY||proportion difference|0.435||||0.0015|TWO_SIDED|95.0|0.2195|0.6551|||Cochran-Mantel-Haenszel|||"Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses.~One-sided adjusted p-value was reported."||0.6551|0.2195|0.0015
71738841|NCT04302545|142990554|OTHER||Odds Ratio (OR)|-0.103||||0.003|TWO_SIDED|95.0|-0.171|-0.035|||Regression, Linear|||||-0.035|-0.171|0.003
71738842|NCT04302545|142990555|OTHER||Odds Ratio (OR)|0.654||||0.336|TWO_SIDED|95.0|-0.682|1.991|||Regression, Linear|||||1.991|-0.682|.336
71738843|NCT04302545|142990556|OTHER||Odds Ratio (OR)|-0.393||||0.021|TWO_SIDED|95.0|-0.725|-0.06|||Regression, Linear|||||-0.06|-0.725|.021
71738844|NCT04302545|142990557|OTHER||Odds Ratio (OR)|-1.89|||<|0.0001|TWO_SIDED|95.0|-2.813|-0.963|||Regression, Linear|||||-0.963|-2.813|<0.0001
71738845|NCT04302545|142990558|OTHER||Odds Ratio (OR)|-1.318|||<|0.0001|TWO_SIDED|95.0|-2.021|-0.614|||Regression, Linear|||||-0.614|-2.021|<.0001
71738846|NCT04302545|142990560|OTHER||Odds Ratio (OR)|-0.065||||0.003|TWO_SIDED|95.0|-0.108|-0.023|||Regression, Linear|||||-.023|-.108|.003
71650028|NCT03566238|142818441|SUPERIORITY||proportion difference|0.211||||0.0174|TWO_SIDED|95.0|0.021|0.4557|||Cochran-Mantel-Haenszel|||Analysis was based on the Cochran Mantel Haenszel test adjusting PFIC type. A pooled analysis for the closed testing procedure was applied to control multiplicity. The one-sided adjusted p-value for an individual dose was calculated as the maximum value of the unadjusted p-value for the pooled analysis and the unadjusted p-value for the individual doses. One-sided adjusted p-value was reported.||0.4557|0.021|0.0174
71650029|NCT04728620|142818453|SUPERIORITY|single group|mean|79.3||||0.001|TWO_SIDED||||||t-test, 1 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is 71 or less."||||0.001
71650030|NCT04728620|142818455|OTHER||Mean Difference (Net)|0.57||||0.005|TWO_SIDED||||||t-test, 2 sided|||||||0.005
71650031|NCT04728620|142818456|OTHER||Mean Difference (Net)|-0.85||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
71650032|NCT04728620|142818457|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended A1c monitoring frequency||||1
71650033|NCT04728620|142818457|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended urine microalbumin screening frequency||||1
71650034|NCT04728620|142818457|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended pneumonia vaccination frequency||||1
71650035|NCT04728620|142818457|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of recommended diabetes eye exam frequency||||1
71650036|NCT04511208|142818468|SUPERIORITY||Difference in means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.7|-1.7|||Repeated measures linear model|||||-1.7|-2.7|<0.001
71650037|NCT04511208|142818469|SUPERIORITY||Difference in means|-0.26||||0.006|TWO_SIDED|95.0|-0.44|-0.08|||Repeated measures linear model|||||-0.08|-0.44|0.006
71650038|NCT04511208|142818470|SUPERIORITY||Difference in means|-0.23||||0.046|TWO_SIDED|95.0|-0.45|-0.005|||Repeated measures linear model|||||-0.005|-0.45|0.046
71886450|NCT00848354|143293327|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
71650039|NCT04511208|142818471|SUPERIORITY||Difference in means|-0.07||||0.955|TWO_SIDED|95.0|-2.51|2.38|||Repeated measures linear model|||C3B PST Score||2.38|-2.51|0.955
71650040|NCT04511208|142818471|SUPERIORITY||Difference in means|0.62||||0.686|TWO_SIDED|95.0|-2.48|3.71|||Repeated measures linear model|||C3B VMT Score||3.71|-2.48|0.686
71739242|NCT00588354|142991254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.83|STANDARD_ERROR_OF_MEAN|3.53||0.186|TWO_SIDED|95.0|-11.75|2.09|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||2.09|-11.75|0.186
71650041|NCT04511208|142818472|SUPERIORITY||Odds Ratio (OR)|2.5||||0.007|TWO_SIDED|95.0|1.28|4.68|||Generalized linear mixed effects model|||||4.68|1.28|0.007
71650042|NCT04511208|142818472|SUPERIORITY||Difference in means|-1.1||||0.009|TWO_SIDED|95.0|-1.82|-0.28|||Repeated measures linear model|||Sensitivity analysis||-0.28|-1.82|0.009
71650043|NCT04511208|142818473|SUPERIORITY||Difference in means|-1.06||||0.004|TWO_SIDED|95.0|-1.75|-0.38|||Repeated measures linear model|||||-0.38|-1.75|0.004
71650044|NCT04511208|142818474|SUPERIORITY||Difference in means|-2.97|||<|0.001|TWO_SIDED|95.0|-3.8|-2.13|||Repeated measures linear model|||||-2.13|-3.80|<0.001
71650045|NCT01488448|142818477|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
71650046|NCT01488448|142818478|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||||||0.77
71650047|NCT01488448|142818479|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Fisher Exact|||||||0.97
71650048|NCT01488448|142818480|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
71650049|NCT01488448|142818481|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.39
71650050|NCT01488448|142818482|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
71650051|NCT01488448|142818485|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
71650052|NCT00243152|142818487|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.||||<0.05
71650053|NCT00243152|142818487|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.||||>0.05
71650054|NCT00243152|142818487|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.||||>0.05
71650055|NCT00243152|142818487|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.||||>0.05
71650056|NCT00243152|142818487|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.||||>0.05
71650057|NCT00243152|142818487|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.||||>0.05
71650058|NCT02875028|142818511|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71650059|NCT00653159|142818526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.||||0.4003
71650060|NCT00653159|142818527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4136|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.||||0.4136
71650061|NCT00653159|142818528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4783|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.||||0.4783
71650062|NCT00653159|142818529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2174|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.||||0.2174
71650063|NCT00653159|142818530|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|Two-sided test||"Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied (happy or very happy) at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types."||||1.0000
71650064|NCT00109837|142818531|SUPERIORITY_OR_OTHER||Proportion in 1-year CCR|0.36|STANDARD_DEVIATION|0.06|||ONE_SIDED|95.0|0.25|||||||The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.|||0.25|
71650065|NCT00401245|142818533|SUPERIORITY_OR_OTHER|||||||0.024||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.024
71650066|NCT00401245|142818534|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||< 0.001
71650067|NCT00401245|142818534|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
71650068|NCT00401245|142818534|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||<0.001
71650069|NCT00401245|142818535|SUPERIORITY_OR_OTHER|||||||0.092||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.092
71650070|NCT00401245|142818535|SUPERIORITY_OR_OTHER|||||||0.997||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.997
71650071|NCT00401245|142818535|SUPERIORITY_OR_OTHER|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor||||0.009
71650072|NCT00401245|142818536|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.078
71650073|NCT00401245|142818536|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.005
71650074|NCT00401245|142818536|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.||||0.929
71886451|NCT00848354|143293327|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71650075|NCT00401245|142818538|SUPERIORITY_OR_OTHER|||||||0.017||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).||||0.017
71650076|NCT00401245|142818545|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.||||<0.001
71650077|NCT00401245|142818545|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.||||< 0.001
71650078|NCT00401245|142818545|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.||||<0.001
71650079|NCT00401245|142818545|SUPERIORITY_OR_OTHER||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.||||<0.001
71650080|NCT02344745|142818548|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71650081|NCT02344745|142818549|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
71650082|NCT02344745|142818550|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71650083|NCT02344745|142818551|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
71650084|NCT01933919|142818587|SUPERIORITY||LS Mean Difference (Fluvoxamine-Placebo)|-4.3|STANDARD_ERROR_OF_MEAN|2.07||0.044|TWO_SIDED|95.0|-8.5|-0.1|||ANCOVA|ANCOVA with baseline JCY-BOCS (10-item) total score and age as covariates and treatment as fixed effect.|The model included the fixed effects of treatment, with baseline JCY-BOCS (10-item) total score and age as covariates.|||-0.1|-8.5|0.044
71650085|NCT00991510|142818599|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.923|||||TWO_SIDED|90.0|0.865|0.984|||ANOVA|||A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.||0.984|0.865|
71650086|NCT00991510|142818600|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.959|||||TWO_SIDED|90.0|0.899|1.023|||ANOVA|||||1.023|0.899|
71650087|NCT00991510|142818601|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.873|||||TWO_SIDED|90.0|0.787|0.968|||ANOVA|||||0.968|0.787|
71650088|NCT00991510|142818602|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.985|||||TWO_SIDED|90.0|0.877|1.106|||ANOVA|||||1.106|0.877|
71650089|NCT01091103|142818678|SUPERIORITY_OR_OTHER|||||||0.9427|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.9427
71650090|NCT01091103|142818679|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED|||||The p-value was not adjusted for multiplicity.|t-test, 2 sided|||||||0.3370
71650091|NCT03449199|142818690|SUPERIORITY||LS Mean Difference|-0.05||||0.7953|TWO_SIDED|95.0|-0.44|0.34|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||0.34|-0.44|0.7953
71650092|NCT03449199|142818690|SUPERIORITY||LS Mean Difference|-0.43||||0.0311|TWO_SIDED|95.0|-0.82|-0.04|||ANCOVA|||Change from baseline in log-transformed UACR was analyzed using an ANCOVA model with randomized treatment, and randomization strata of sUA and UACR as independent variables. The last observation carried forward imputation was used for missing data. In this study, multiplicity was not considered since the study objective is exploratory.||-0.04|-0.82|0.0311
71650093|NCT03449199|142818691|SUPERIORITY||LS Mean Difference|1.71||||0.4055|TWO_SIDED|95.0|-2.35|5.78|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||5.78|-2.35|0.4055
71886452|NCT00848354|143293329|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71650094|NCT03449199|142818691|SUPERIORITY||LS Mean Difference|3.42||||0.096|TWO_SIDED|95.0|-0.62|7.46|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of sUA and UACR levels as independent variables, Baseline eGFR as covariate is fitted. The last observation carried forward imputation was used for missing data.||7.46|-0.62|0.0960
71650095|NCT03449199|142818692|SUPERIORITY||LS Mean Difference|-2.43|||<|0.0001|TWO_SIDED|95.0|-3.13|-1.74|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-1.74|-3.13|<0.0001
71650096|NCT03449199|142818692|SUPERIORITY||LS Mean Difference|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.54|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||-2.54|-3.91|<0.0001
71650097|NCT03449199|142818693|SUPERIORITY||LS Mean Difference|-102.02||||0.3955|TWO_SIDED|95.0|-338.81|134.78|||ANCOVA|||For Week 12 (visit of the primary outcome), an ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||134.78|-338.81|0.3955
71650098|NCT03449199|142818693|SUPERIORITY||LS Mean Difference|-197.49||||0.0991|TWO_SIDED|95.0|-432.73|37.75|||ANCOVA|||For Week 12 (visit of the primary outcome), ANCOVA model with treatment, randomization strata of UACR levels as independent variables is fitted. The last observation carried forward imputation was used for missing data.||37.75|-432.73|0.0991
71650099|NCT03449199|142818694|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2791|TWO_SIDED||||||Regression, Logistic||Missing observations at Study Week 12 are imputed as nonresponse.|Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.2791
71650100|NCT03449199|142818694|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0507|TWO_SIDED||||||Regression, Logistic|||Odds ratio, 95% CLs, and p-values are obtained from logistic regression model adjusting for treatment group, randomization strata of Baseline sUA (\<6.0 vs ≥6.0 mg/dL) and Baseline UACR (200 to \<300 mg/g vs 300 to ≤3000 mg/g), Baseline UACR and Baseline sUA levels. Odds ratio for a baseline covariate is the ratio of odds over one unit increase of the covariate and it is assumed constant. P-value represents the statistical significance level of odds ratio differing from 1.||||0.0507
71650101|NCT03244475|142818752|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.|Mean Difference (Final Values)|1.6||||0.01|TWO_SIDED|95.0|1.1|2.2||The corrected p-value of 0.01 was chosen after the standard cluster analysis for correcting family-wise error across different voxels.|Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||The analysis was performed for the voxel-wise delta-band activity from the frontal pole and inferior frontal gyri. Spatial smoothing and logarithm transformation (e-based) were performed. Resting-state MEG activity differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||2.2|1.1|0.01
71650102|NCT03244475|142818753|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650103|NCT03244475|142818754|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650104|NCT03244475|142818755|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650105|NCT03244475|142818756|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650106|NCT03244475|142818757|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650107|NCT03244475|142818758|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650108|NCT03244475|142818759|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650109|NCT03244475|142818760|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650110|NCT03244475|142818761|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71824380|NCT03006341|143152750|OTHER||Adjusted R squared statistic|0.02|||||||||||Regression, Linear|Logistic regression model with serum creatinine as the dependent variable and treatment groups and claims based variables as the independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
71739243|NCT00588354|142991255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|3.37||0.918|TWO_SIDED|95.0|-6.96|6.26|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.||6.26|-6.96|0.918
71886453|NCT00848354|143293331|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71650111|NCT03244475|142818762|SUPERIORITY|Statistical analysis was carried out for the DIFFERENCE scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650112|NCT03244475|142818763|SUPERIORITY|Statistical analysis was carried out for the difference scores to assess group differences between TES and Sham groups.||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was chosen due to potential non-normal distribution for the difference scores.||Differences between pre- and post-treatment measures were obtained as difference scores for TES and Sham separately. The null hypothesis was that there was no group difference in the pre- and post-treatment difference scores between TES and Sham groups||||0.05
71650113|NCT03404401|142818765|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71650114|NCT00988208|142818770|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.0017|TWO_SIDED|95.0|1.17|2.0||p-value is based on unstratified log-rank test|Log Rank|||||2.00|1.17|0.0017
71650115|NCT00988208|142818771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.0187|TWO_SIDED|95.0|1.05|1.66|||Log Rank|P-value is based on unstratified log-rank test||||1.66|1.05|0.0187
71650116|NCT00988208|142818772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3975|TWO_SIDED|95.0|0.665|1.176|||Chi-squared|||||1.176|0.665|0.3975
71650117|NCT03008837|142818780|OTHER|Using seed-based analysis with a right posterior insula seed, cluster size was set at 40 voxels, and p-value was thresholded at p\<0.05 to compare the differences between the two groups in terms of connectivity between the right posterior insula and areas of the DMN identified based on a priori hypotheses.|Mean Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided||Standard therapy control (post-pre) was subtracted from PENFS (post-pre).|PENFS (post-pre) - Standard Therapy (post-pre)||||<0.05
71650118|NCT02780167|142818799|OTHER||Estimate difference|1.8|STANDARD_ERROR_OF_MEAN|0.99||0.121|TWO_SIDED|95.0|-0.7|4.4|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||4.4|-0.7|0.1210
71650119|NCT02780167|142818799|OTHER||Estimate difference|6.0|STANDARD_ERROR_OF_MEAN|3.05||0.1065|TWO_SIDED|95.0|-1.8|13.8|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||13.8|-1.8|0.1065
71650120|NCT02780167|142818799|OTHER||Estimate difference|21.5|STANDARD_ERROR_OF_MEAN|6.25||0.0184|TWO_SIDED|95.0|5.5|37.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||37.6|5.5|0.0184
71650121|NCT02780167|142818799|OTHER||Mean Difference (Final Values)|38.2|STANDARD_ERROR_OF_MEAN|7.18||0.0032|TWO_SIDED|95.0|19.7|56.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||56.6|19.7|0.0032
71650122|NCT02780167|142818800|OTHER||LS mean difference|4.08|STANDARD_ERROR_OF_MEAN|9.667||0.6731|TWO_SIDED|90.0|-11.88|20.05|||Mixed Models Analysis|Mixed-effects model repeated measures (MMRM) with observed cases (OC)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.|||20.05|-11.88|0.6731
71886454|NCT00848354|143293333|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71650123|NCT02780167|142818800|OTHER||LS mean difference|-5.52|STANDARD_ERROR_OF_MEAN|9.474||0.561|TWO_SIDED|90.0|-21.16|10.13|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 30 mg QD, Reference group: Placebo.|||10.13|-21.16|0.5610
71650124|NCT02780167|142818800|OTHER||LS mean difference|-23.82|STANDARD_ERROR_OF_MEAN|9.043||0.0091|TWO_SIDED|90.0|-38.76|-8.88|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 100 mg QD, Reference group: Placebo.|||-8.88|-38.76|0.0091
71650125|NCT02780167|142818800|OTHER||LS mean difference|-47.35|STANDARD_ERROR_OF_MEAN|9.008|<|0.0001|TWO_SIDED|90.0|-62.23|-32.47|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 200 mg QD, Reference group: Placebo.|||-32.47|-62.23|<0.0001
71650126|NCT03180801|142818824|OTHER|||||||0.03|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.03
71650127|NCT03180801|142818824|OTHER|||||||0.07|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.||||0.07
71650128|NCT03180801|142818825|OTHER|One sided Fisher's exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.||||||0.647|||||||Fisher Exact|||One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.||||0.647
71650129|NCT03180801|142818825|OTHER|||||||1|||||||Fisher Exact|||One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.||||1.00
71650130|NCT03180801|142818825|OTHER|||||||0.024|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.0240
71650131|NCT03180801|142818825|OTHER|||||||0.186|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.||||0.186
71650132|NCT03180801|142818827|OTHER|||||||0.465|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.465
71650133|NCT03180801|142818827|OTHER|||||||0.074|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom||||0.074
71650134|NCT03180801|142818827|OTHER|||||||0.024|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms||||0.024
71650135|NCT03180801|142818827|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.||||0.230
71650136|NCT03180801|142818827|OTHER|||||||0.09|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.09
71824381|NCT03006341|143152752|OTHER||Adjusted R squared statistic|0.04|||||||||||Regression, Linear|Linear regression model with duration of atrial fibrillation as dependent and treatment groups and claims based variables as independent variables|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
71824382|NCT03006341|143152758|OTHER||C-Statistic|0.88|||||||||||Regression, Logistic|Logistic regression model with diabetes as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
71824383|NCT03006341|143152759|OTHER||C-Statistic|0.69|||||||||||Regression, Logistic|Logistic regression model with hyperlipidemia as the dependent variable and treatment groups and claims based variables as the independent variables.|The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|"The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the concordance statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model."||||
71824384|NCT03006341|143152760|OTHER||Adjusted R squared statistic|0.34|||||||||||Regression, Linear|Linear regression model with HAS-BLED score as the dependent variable and treatment groups and claims based variables as the independent variables.|The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.||||
71824385|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-4.3|12.3|||||RD is for retention 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||12.3|-4.3|
71886455|NCT00848354|143293335|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.1975
71886456|NCT00848354|143293336|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.||||0.0044
71650137|NCT03180801|142818827|OTHER|||||||0.22|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding||||0.22
71650138|NCT03180801|142818827|OTHER|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.23
71650139|NCT03180801|142818827|OTHER|||||||0.12|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding||||0.12
71650140|NCT03180801|142818828|OTHER|||||||0.0501|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.0501
71650141|NCT03180801|142818828|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.||||0.3139
71739244|NCT04000581|142991256|SUPERIORITY|||||||0.329|||||||t-test, 1 sided|||The null hypothesis is that the mean change is equal between the groups, while the alternative is that an increased difference is observed in arm 2. The hypotheses are evaluated using a one-sided, two-sample t-test.||||0.329
71650142|NCT03180801|142818829|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.||||0.102
71650143|NCT03180801|142818829|OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.||||0.481
71650144|NCT03180801|142818830|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.128
71650145|NCT03180801|142818830|OTHER|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.||||0.601
71650146|NCT03180801|142818831|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.142
71650147|NCT03180801|142818831|OTHER|||||||0.147|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.||||0.147
71650148|NCT03180801|142818832|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.080
71650149|NCT03180801|142818832|OTHER|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.||||0.271
71650150|NCT03180801|142818833|OTHER|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.099
71739245|NCT02519595|142991272|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71650151|NCT03180801|142818833|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.||||0.178
71650152|NCT03180801|142818834|OTHER|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.064
71650153|NCT03180801|142818834|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.||||0.201
71650154|NCT03180801|142818835|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison on day -2||||<0.001
71650155|NCT03180801|142818835|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparion on day -2||||<0.001
71650156|NCT03180801|142818835|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
71650157|NCT03180801|142818835|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 35||||<0.001
71650158|NCT03180801|142818835|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
71650159|NCT03180801|142818835|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison on day 63||||<0.001
71650160|NCT03756883|142818836|EQUIVALENCE|The 90% Confidence Interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|101.8|||||TWO_SIDED|90.0|92.68|111.94||||||||111.94|92.68|
71650161|NCT03756883|142818837|EQUIVALENCE|The 90% confidence interval for the test-to-reference ratio was calculated using a procedure similar to Fieller's method.|Test-to-Reference Ratio|98.09|||||TWO_SIDED|90.0|87.1|110.61||||||||110.61|87.10|
71650162|NCT03756883|142818838|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of the test product over the placebo.||||<0.0001
71650163|NCT03756883|142818838|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of Reference to placebo.||||<0.0001
71650164|NCT03756883|142818839|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of test over placebo.||||<0.0001
71739246|NCT02519595|142991273|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
71650165|NCT03756883|142818839|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Superiority of reference to placebo.||||<0.0001
71650166|NCT02445287|142818840|SUPERIORITY_OR_OTHER|||||||0.92||||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.920
71650167|NCT02445287|142818841|SUPERIORITY_OR_OTHER|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.000
71650168|NCT02445287|142818842|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval = (-0.25, 0.25)||||||0||||||level of significance (alpha) = 0.05|Equivalence test|||||||0.000
71650169|NCT02445287|142818843|SUPERIORITY_OR_OTHER|||||||0.012||||||level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.012
71650170|NCT03235479|142818844|SUPERIORITY||Risk Difference (RD)|4.9||||0.0298|TWO_SIDED|95.0|0.5|9.3|||Cochran-Mantel-Haenszel|||||9.3|0.5|0.0298
71650171|NCT03235479|142818845|SUPERIORITY||Risk Difference (RD)|8.9||||0.0016|TWO_SIDED|95.0|3.4|14.4|||Cochran-Mantel-Haenszel|||||14.4|3.4|0.0016
71650172|NCT03235479|142818846|SUPERIORITY||Risk Difference (RD)|10.2||||0.0005|TWO_SIDED|95.0|4.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|4.4|0.0005
71650173|NCT03235479|142818847|SUPERIORITY||Risk Difference (RD)|7.7||||0.0299|TWO_SIDED|95.0|0.8|14.6|||Cochran-Mantel-Haenszel|||||14.6|0.8|0.0299
71650174|NCT03235479|142818848|SUPERIORITY||Risk Difference (RD)|10.3||||0.0006|TWO_SIDED|95.0|4.4|16.2|||Cochran-Mantel-Haenszel|||||16.2|4.4|0.0006
71650175|NCT03235479|142818849|SUPERIORITY||Risk Difference (RD)|5.2||||0.1815|TWO_SIDED|95.0|-2.4|12.9||P-value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.9|-2.4|0.1815
71650176|NCT03110380|142818864|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|-0.7|||||TWO_SIDED|95.001|-2.8|1.0|||||The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.||1.0|-2.8|
71650177|NCT03110380|142818864|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
71650178|NCT03110380|142818865|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group -DTG+F/TAF group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|2.2|||||TWO_SIDED|95.001|-2.3|6.8|||||The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.8|-2.3|
71650179|NCT03110380|142818866|SUPERIORITY||Difference in LSM|-18.0||||0.23|TWO_SIDED|95.0|-46.0|11.0|||ANOVA|P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.||||11|-46|0.23
71650180|NCT04480307|142818868|SUPERIORITY||LS Mean Difference|-0.031||||0.5084|TWO_SIDED|95.0|-0.124|0.063|||ANCOVA|||||0.063|-0.124|0.5084
71650181|NCT04480307|142818868|SUPERIORITY||Difference of change from Baseline|-0.021|||||TWO_SIDED|95.0|-0.121|0.057|||Bayesian|Difference of change from baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.057|-0.121|
71650182|NCT04480307|142818869|SUPERIORITY||LS Mean Difference|-0.002||||0.9472|TWO_SIDED|95.0|-0.052|0.049|||ANCOVA|||||0.049|-0.052|0.9472
71650183|NCT04480307|142818869|SUPERIORITY||Difference of change from Baseline|0.012|||||TWO_SIDED|95.0|-0.036|0.059|||Bayesian|Difference of change from Baseline a posteriori.||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.059|-0.036|
71650184|NCT04480307|142818870|SUPERIORITY||LS Mean Difference|0.154||||0.4027|TWO_SIDED|95.0|-0.216|0.524|||ANCOVA|||ANCOVA analysis for T1 lesion volume parameter||0.524|-0.216|0.4027
71739247|NCT02519595|142991274|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71739248|NCT02519595|142991276|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Adverse events in ED||||0.8
71650185|NCT04480307|142818870|SUPERIORITY||LS Mean Difference|0.01||||0.7428|TWO_SIDED|95.0|-0.051|0.071|||ANCOVA|||ANCOVA analysis for T2 lesion volume parameter||0.071|-0.051|0.7428
71650186|NCT04480307|142818871|SUPERIORITY||LS Mean Difference|0.003||||0.7314|TWO_SIDED|95.0|-0.013|0.018|||ANCOVA|||||0.018|-0.013|0.7314
71650187|NCT04480307|142818871|SUPERIORITY||Difference of change from Baseline|0.005|||||TWO_SIDED|95.0|-0.01|0.023|||Bayesian|Difference of change from Baseline a posteriori||Bayesian analysis is done using a non-informative prior on the mean observed difference.||0.023|-0.010|
71650188|NCT04480307|142818872|SUPERIORITY||LS Mean Difference|0.0||||0.7662|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||||0|0|0.7662
71650189|NCT02010996|142818933|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||0.05
71650190|NCT04234464|142818950|SUPERIORITY||Mean Difference (Final Values)|13.51|||<|0.001|TWO_SIDED|95.0|10.09|16.94|||Mixed Models Analysis|||Maximum percentage fall in post-dose pre-exercise FEV₁ up to 60 minutes post-exercise challenge is analyzed using a mixed effects model adjusted for treatment, treatment period, treatment sequence as categorical fixed effects, period-specific pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||16.94|10.09|<0.001
71650191|NCT04234464|142818951|SUPERIORITY||Odds Ratio (OR)|10.548|||<|0.001|TWO_SIDED|95.0|4.311|25.805|||Mixed Models Analysis|||A generalized linear mixed model with logit link adjusted for treatment, treatment period and treatment sequence as fixed effects, pre-dose baseline FEV₁ and average pre-dose baseline FEV₁ as continuous covariates, and a random subject within treatment sequence effect.||25.805|4.311|<0.001
71650192|NCT02412722|142818968|SUPERIORITY||Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.46|0.76||||||||0.76|0.46|
71650193|NCT02412722|142818969|SUPERIORITY||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.59|1.36||||||||1.36|0.59|
71650194|NCT02412722|142818970|SUPERIORITY||Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.72|1.49||||||||1.49|0.72|
71650195|NCT02412722|142818974|SUPERIORITY||Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.78|1.47||||||||1.47|0.78|
71650196|NCT02412722|142818975|SUPERIORITY||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.75|1.68||||||||1.68|0.75|
71738847|NCT02106403|142990597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.46||||0.0659|TWO_SIDED|95.0|-0.37|11.29|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||11.29|-0.37|0.0659
71650197|NCT02412722|142818976|SUPERIORITY||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.26||||||||1.26|0.67|
71650198|NCT00373425|142818995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3235|TWO_SIDED|95.0|0.741|1.104||If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.|Log Rank||Hazard ratio: erlotinib to placebo|The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.||1.104|0.741|0.3235
71650199|NCT00373425|142819000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.562|TWO_SIDED|95.0|0.78|1.144|||Log Rank|||The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.||1.144|0.780|0.5620
71738848|NCT02106403|142990597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.99||||0.0928|TWO_SIDED|95.0|-0.84|10.81|||ANCOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.81|-0.84|0.0928
71650200|NCT00551616|142819018|OTHER||% of observed pregnancies|1.78|||<|0.001|TWO_SIDED|95.0|1.04|2.98|||Chi-squared||Expected pregnancy rate = 5.58%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||2.98|1.04|<0.001
71650201|NCT00551616|142819018|OTHER||% of observed pregnancies|2.59|||<|0.001|TWO_SIDED|95.0|1.68|3.94|||Chi-squared||Expected pregnancy rate = 5.43%|Comparison of % of observed pregnancies vs % of expected pregnancies based on Trussell 1998||3.94|1.68|<0.001
71650202|NCT01263561|142819020|NON_INFERIORITY_OR_EQUIVALENCE|A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||.85
71650203|NCT01263561|142819021|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only for main outcome measure of IOP.||||||0.24|TWO_SIDED||||||Kaplan Meier|||||||.24
71650204|NCT01263561|142819022|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation only performed for main outcome measure of IOP.||||||0.8|TWO_SIDED|||||Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.|Chi-squared|||||||0.80
71650205|NCT01396421|142819024|SUPERIORITY_OR_OTHER||Treatment difference|-8.18|||<|0.0001|TWO_SIDED|95.0|-12.0|-4.4||Primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) which included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed.||-4.40|-12.0|<0.0001
71650206|NCT01396421|142819024|SUPERIORITY_OR_OTHER||Treatment difference|-7.64||||0.0006|TWO_SIDED|95.0|-12.0|-3.3|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-3.30|-12.0|0.0006
71739249|NCT02519595|142991276|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||Post discharge Emesis||||0.5
71650207|NCT01396421|142819024|SUPERIORITY_OR_OTHER||Traetment difference|-8.72|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.37|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||-4.37|-13.1|<0.0001
71650208|NCT01396421|142819024|SUPERIORITY_OR_OTHER||Treatment difference|-2.89||||0.291|TWO_SIDED|95.0|-8.27|2.49|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of -7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test||2.49|-8.27|0.2910
71650209|NCT01396421|142819025|SUPERIORITY_OR_OTHER||Treatment difference|-0.36||||0.0006|TWO_SIDED|95.0|-0.56|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between the average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed at a significance level of 0.05.||-0.15|-0.56|0.0006
71650210|NCT01396421|142819025|SUPERIORITY_OR_OTHER||Treatment difference|-0.38||||0.0012|TWO_SIDED|95.0|-0.61|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.15|-0.61|0.0012
71650211|NCT01396421|142819025|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||-0.10|-0.56|0.0056
71650212|NCT01396421|142819025|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.8491|TWO_SIDED|95.0|-0.31|0.26|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||||0.26|-0.31|0.8491
71650213|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-1.5||||0.0644|TWO_SIDED|95.0|-3.09|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, and baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.09|-3.09|0.0644
71650214|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-1.99||||0.0139|TWO_SIDED|95.0|-3.58|-0.41||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||-0.41|-3.58|0.0139
71650215|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|0.35||||0.7231|TWO_SIDED|95.0|-1.61|2.32||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||2.32|-1.61|0.7231
71650216|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-5.14||||0.0018|TWO_SIDED|95.0|-8.36|-1.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-1.93|-8.36|0.0018
71650217|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-3.75||||0.0045|TWO_SIDED|95.0|-6.33|-1.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 2||||-1.17|-6.33|0.0045
71650218|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|1.84||||0.2568|TWO_SIDED|95.0|-1.34|5.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||5.02|-1.34|0.2568
71650219|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-4.4||||0.0009|TWO_SIDED|95.0|-6.97|-1.82||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-1.82|-6.97|0.0009
71650220|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-3.45||||0.036|TWO_SIDED|95.0|-6.67|-0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.23|-6.67|0.0360
71650221|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9876|TWO_SIDED|95.0|-4.53|4.6||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||4.60|-4.53|0.9876
71650222|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-7.61|||<|0.0001|TWO_SIDED|95.0|-11.3|-3.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-3.93|-11.3|<0.0001
71650223|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-5.16||||0.0062|TWO_SIDED|95.0|-8.85|-1.47||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 4||||-1.47|-8.85|0.0062
71650224|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|1.93||||0.3407|TWO_SIDED|95.0|-2.05|5.9||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||5.90|-2.05|0.3407
71650225|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-7.86||||0.0001|TWO_SIDED|95.0|-11.9|-3.86||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 5||||-3.86|-11.9|0.0001
71739250|NCT02519595|142991277|SUPERIORITY_OR_OTHER|||||||0.011|||||||Chi-squared|||||||0.011
71739251|NCT00387036|142991278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.59|-0.25||||||||-0.25|-1.59|
71650226|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-7.15||||0.0005|TWO_SIDED|95.0|-11.2|-3.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-3.14|-11.2|0.0005
71650227|NCT01396421|142819026|SUPERIORITY_OR_OTHER||Treatment difference|-1.12||||0.657|TWO_SIDED|95.0|-6.07|3.83||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.|||3.83|-6.07|0.6570
71650228|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.6553|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6553
71650229|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.03||||0.617|TWO_SIDED|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1||||0.08|-0.13|0.6170
71650230|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|0.03||||0.6446|TWO_SIDED|95.0|-0.1|0.15||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates..|Mixed Models Analysis|Week 1||||0.15|-0.10|0.6446
71650231|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.0347|TWO_SIDED|95.0|-0.29|-0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||-0.01|-0.29|0.0347
71650232|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Leasr squares mean|-0.12||||0.0825|TWO_SIDED|95.0|-0.27|0.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.02|-0.27|0.0825
71650233|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|0.12||||0.1678|TWO_SIDED|95.0|-0.05|0.3||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2||||0.30|-0.05|0.1678
71650234|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.0219|TWO_SIDED|95.0|-0.39|-0.03||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||-0.03|-0.39|0.0219
71650235|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Least squares mean|-0.09||||0.3275|TWO_SIDED|95.0|-0.27|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.09|-0.27|0.3275
71650236|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.1173|TWO_SIDED|95.0|-0.04|0.4||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3||||0.40|-0.04|0.1173
71650237|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.21||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||-0.21|-0.63|<0.0001
71650238|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Least squares mean|-0.19||||0.0662|TWO_SIDED|95.0|-0.4|0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.01|-0.40|0.0662
71650239|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7587|TWO_SIDED|95.0|-0.3|0.22||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4||||0.22|-0.30|0.7587
71650240|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.39||||0.0006|TWO_SIDED|95.0|-0.61|-0.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.17|-0.61|0.0006
71650241|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Least squares mean|-0.34||||0.0032|TWO_SIDED|95.0|-0.56|-0.11||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||-0.11|-0.56|0.0032
71650242|NCT01396421|142819027|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.7619|TWO_SIDED|95.0|-0.32|0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5||||0.23|-0.32|0.7619
71650243|NCT01396421|142819028|SUPERIORITY_OR_OTHER||Treatment difference|2.46||||0.0557|TWO_SIDED|95.0|-0.06|4.98||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.98|-0.06|0.0557
71650244|NCT01396421|142819028|SUPERIORITY_OR_OTHER||Treatment difference|2.89||||0.025|TWO_SIDED|95.0|0.37|5.42||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||5.42|0.37|0.0250
71650245|NCT01396421|142819028|SUPERIORITY_OR_OTHER||Treatment difference|1.58||||0.3264|TWO_SIDED|95.0|-1.58|4.74||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6||||4.74|-1.58|0.3264
71650246|NCT01396421|142819029|SUPERIORITY_OR_OTHER||Treatment difference|-2.44||||0.001|TWO_SIDED|95.0|-3.88|-0.99||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.99|-3.88|0.0010
71650247|NCT01396421|142819029|SUPERIORITY_OR_OTHER||Treatment difference|-2.22||||0.0029|TWO_SIDED|95.0|-3.67|-0.77||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.77|-3.67|0.0029
71650248|NCT01396421|142819029|SUPERIORITY_OR_OTHER||Treatment difference|-1.11||||0.2227|TWO_SIDED|95.0|-2.9|0.68||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.68|-2.90|0.2227
71650249|NCT01396421|142819030|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.0069|TWO_SIDED|95.0|-2.44|0.39||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.39|-2.44|0.0069
71650250|NCT01396421|142819030|SUPERIORITY_OR_OTHER||Least squares mean|-1.78||||0.0007|TWO_SIDED|95.0|-2.81|-0.76||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.76|-2.81|0.0007
71650251|NCT01396421|142819030|SUPERIORITY_OR_OTHER||Treatmetn difference|-1.07||||0.0996|TWO_SIDED|95.0|-2.33|0.2||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.20|-2.33|0.0996
71650252|NCT01396421|142819031|SUPERIORITY_OR_OTHER||Treatment difference|-0.5||||0.0004|TWO_SIDED|95.0|-0.77|-0.22||The Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.22|-0.77|0.0004
71650253|NCT01396421|142819031|SUPERIORITY_OR_OTHER||Treatment difference|-0.54||||0.0002|TWO_SIDED|95.0|-0.82|-0.26||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||-0.26|-0.82|0.0002
71824386|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|9.1|||||TWO_SIDED|95.0|0.9|17.2|||||RD is for retention 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||17.2|0.9|
71650254|NCT01396421|142819031|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.4505|TWO_SIDED|95.0|-0.5|0.22||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel|||||0.22|-0.50|0.4505
71650255|NCT01396421|142819032|SUPERIORITY_OR_OTHER||Relative risk|1.48||||0.0032|TWO_SIDED|95.0|1.14|1.91||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.91|1.14|0.0032
71650256|NCT01396421|142819032|SUPERIORITY_OR_OTHER||Relative risk|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.05||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||2.05|1.23|0.0004
71650257|NCT01396421|142819032|SUPERIORITY_OR_OTHER||Relative risk|1.27||||0.1576|TWO_SIDED|95.0|0.92|1.76||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel|||||1.76|0.92|0.1576
71650258|NCT01396421|142819033|SUPERIORITY_OR_OTHER||Treatment difference|-1.1||||0.0246|TWO_SIDED|95.0|-2.06|-0.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.14|-2.06|0.0246
71650259|NCT01396421|142819033|SUPERIORITY_OR_OTHER||Treatment difference|-1.22||||0.0131|TWO_SIDED|95.0|-2.19|-0.26||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.26|-2.19|0.0131
71650260|NCT01396421|142819033|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.5706|TWO_SIDED|95.0|-1.53|0.85||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.85|-1.53|0.5706
71650261|NCT01396421|142819034|SUPERIORITY_OR_OTHER||Relative risk|0.39||||0.0143|TWO_SIDED|95.0|0.18|0.85|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.||||0.85|0.18|0.0143
71650262|NCT01396421|142819034|SUPERIORITY_OR_OTHER||Relative risk|0.87||||0.6606|TWO_SIDED|95.0|0.46|1.65||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.65|0.46|0.6606
71650263|NCT01396421|142819034|SUPERIORITY_OR_OTHER||Relative risk|0.77||||0.5115|TWO_SIDED|95.0|0.35|1.68||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel|||||1.68|0.35|0.5115
71650264|NCT01396421|142819035|SUPERIORITY_OR_OTHER||Treatment difference|-2.34||||0.0014|TWO_SIDED|95.0|-3.77|-0.91||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.91|-3.77|0.0014
71650265|NCT01396421|142819035|SUPERIORITY_OR_OTHER||Treatment difference|-2.47||||0.0008|TWO_SIDED|95.0|-3.91|-1.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-1.04|-3.91|0.0008
71650266|NCT01396421|142819035|SUPERIORITY_OR_OTHER||Treatment difference|-0.89||||0.3263|TWO_SIDED|95.0|-2.66|0.89||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|||||0.89|-2.66|0.3263
71650267|NCT01396421|142819036|SUPERIORITY_OR_OTHER||Treatment difference|-1.3||||0.0155|TWO_SIDED|95.0|-2.35|-0.25||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.25|-2.35|0.0155
71650268|NCT01396421|142819036|SUPERIORITY_OR_OTHER||Treatment difference|-1.68||||0.0019|TWO_SIDED|95.0|-2.73|-0.62||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.62|-2.73|0.0019
71650269|NCT01396421|142819036|SUPERIORITY_OR_OTHER||Treatment difference|-0.86||||0.1956|TWO_SIDED|95.0|-2.17|0.44||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.44|-2.17|0.1956
71650270|NCT01396421|142819037|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.75|-2.76|0.0007
71650271|NCT01396421|142819037|SUPERIORITY_OR_OTHER||Treatment difference|-1.98||||0.0001|TWO_SIDED|95.0|-2.98|-0.97||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.97|-2.98|0.0001
71650272|NCT01396421|142819037|SUPERIORITY_OR_OTHER||Treatment difference|-0.72||||0.2572|TWO_SIDED|95.0|-1.96|0.52||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.52|-1.96|0.2572
71650273|NCT01396421|142819038|SUPERIORITY_OR_OTHER||Treatment difference|-1.07||||0.0085|TWO_SIDED|95.0|-1.87|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.87|0.0085
71650274|NCT01396421|142819038|SUPERIORITY_OR_OTHER||Treatment difference|-1.08||||0.0081|TWO_SIDED|95.0|-1.88|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||-0.28|-1.88|0.0081
71650275|NCT01396421|142819038|SUPERIORITY_OR_OTHER||Treatment difference|-0.33||||0.5172|TWO_SIDED|95.0|-1.31|0.66||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.66|-1.31|0.5172
71650276|NCT01396421|142819039|SUPERIORITY_OR_OTHER||Treatment difference|-0.34||||0.3284|TWO_SIDED|95.0|-1.03|0.35||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.35|-1.03|0.3284
71650277|NCT01396421|142819039|SUPERIORITY_OR_OTHER||Treatment difference|-0.65||||0.0655|TWO_SIDED|95.0|-1.34|0.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.04|-1.34|0.0655
71650278|NCT01396421|142819039|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.6251|TWO_SIDED|95.0|-1.07|0.64||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|||||0.64|-1.07|0.6251
71650279|NCT01835548|142819069|SUPERIORITY||Least Square Mean Difference|-11.04|STANDARD_ERROR_OF_MEAN|1.4239|<|0.0001|TWO_SIDED|95.0|-13.9|-8.2|||ANCOVA|||||-8.20|-13.9|<0.0001
71650280|NCT01989676|142819123|EQUIVALENCE|The hypothesis to be tested in this study was that the risk ratio of ORR of PF-05280014 versus that of trastuzumab-EU by Week 25 (+/-14 days) was within a pre-specified margin of 0.80 to 1.25.|Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.842|1.049||||||Risk Ratio and associated 95% confidence interval (CI) are unstratified and based on the Miettinen and Nurminen method.||1.049|0.842|
71650281|NCT01989676|142819124|SUPERIORITY||Cox Proportional Hazard|1.0||||0.505|TWO_SIDED|95.0|0.8|1.26||1-sided log-rank test was used to compare the PFS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and estrogen receptor (ER) status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.26|0.80|0.505
71650282|NCT01989676|142819125|SUPERIORITY||Cox Proportional Hazard|0.92||||0.304|TWO_SIDED|95.0|0.67|1.27||1-sided log-rank test was used to compare the DOR distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.27|0.67|0.304
71650283|NCT01989676|142819126|SUPERIORITY||Cox Proportional Hazard|0.929||||0.339|TWO_SIDED|95.0|0.656|1.316||1-sided log-rank test was used to compare the OS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative).|Log Rank||The 95% CI for the hazard ratio was based on the Cox's proportional hazard model.|||1.316|0.656|0.339
71650284|NCT03941834|142819133|OTHER||Least square (LS) mean difference|0.7|||||TWO_SIDED|95.0|0.1|1.2||||||Analysis were performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.2|0.1|
71650285|NCT03941834|142819138|OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-6.8|11.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline Penn-FPS-R as a covariate; and participant as a random effect.||11.5|-6.8|
71650286|NCT03941834|142819139|OTHER||LS Mean Difference|1.5|||||TWO_SIDED|95.0|-3.8|6.9||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline pain disability index as a covariate; and participant as a random effect.||6.9|-3.8|
71650287|NCT03941834|142819140|OTHER||LS Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.7|0.5||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; and participant as a random effect.||0.5|-0.7|
71650288|NCT03941834|142819141|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|0.1|1.4||||||Analysis was performed using a mixed model with fixed effects for treatment, period and sequence; baseline NPRS as a covariate; and participant as a random effect.||1.4|0.1|
71650289|NCT03941834|142819142|OTHER||Odds Ratio (OR)|12.6|||||TWO_SIDED|95.0|0.7|229.6||||||Analysis was performed using a logistic regression model, including fixed effects for treatment, sequence, period and baseline NPRS score as a covariate.||229.6|0.7|
71650290|NCT01560819|142819150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Wilcoxon signed rank test|||A power calculation was not done for this pilot study. Changes in PUCAI post-treatment were compared with baseline using the Wilcoxon signed rank test. P value \<0.05 was considered statistically significant.||||0.03
71739252|NCT00387036|142991279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|1.9||||90.0|-0.28|6.61||||||||6.61|-0.28|
71650291|NCT02788513|142819151|OTHER|||||||0.9931||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Beta model fit.|Model assumption: 75% of max effect is achieved at 2 mg, 87.5% at 5 mg, 25% at 25 mg, max effect achieved at 10 mg of BI 425809, scalar parameter = 26||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9931
71650292|NCT02788513|142819151|OTHER|||||||0.9225||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit.|Model assumption: 20% of the maximum effect is achieved at 2 mg||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9225
71650293|NCT02788513|142819151|OTHER|||||||0.9287||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Sigmoidal Emax model fit.|Model assumption: 25% of max effect achieved at 5 mg and 75% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9287
71650294|NCT02788513|142819151|OTHER|||||||0.7646||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.7646
71650295|NCT02788513|142819151|OTHER|||||||0.9335||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod linear in log model fit.|No assumption needed.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.9335
71650296|NCT02788513|142819151|OTHER|||||||0.8199||||||An alpha of 0.05 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod logistic model fit.|Model assumption: 10% of max effect achieved at 5 mg and 50% of max effect achieved at 10 mg of BI 425809.||Multiple comparison procedures and modelling (MCPmod) techniques for mixed model repeated measures (MMRM) was used.||||0.8199
71650297|NCT02788513|142819151|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.58||0.934|TWO_SIDED|95.0|-1.09|1.18||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.18|-1.09|0.9340
71650298|NCT02788513|142819151|OTHER||Median Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.6041|TWO_SIDED|95.0|-0.84|1.44||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.44|-0.84|0.6041
71650299|NCT02788513|142819151|OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.58||0.1926|TWO_SIDED|95.0|-0.38|1.9||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.90|-0.38|0.1926
71650300|NCT02788513|142819151|OTHER||Median Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.58||0.9739|TWO_SIDED|95.0|-1.16|1.12||p-values are nominal without multiplicity adjustment.|MMRM|MMRM information is described in the description section.||Mixed model repeated measures (MMRM)||1.12|-1.16|0.9739
71650301|NCT02788513|142819152|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.76||0.979|TWO_SIDED|95.0|-1.48|1.52||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||1.52|-1.48|0.979
71650302|NCT02788513|142819152|OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.77||0.521|TWO_SIDED|95.0|-1.01|2.0||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||2.00|-1.01|0.521
71650303|NCT02788513|142819152|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.77||0.047|TWO_SIDED|95.0|-3.04|-0.02||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.02|-3.04|0.047
71650304|NCT02788513|142819152|OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED|95.0|-3.65|-0.67||p-values are nominal without multiplicity adjustment.|ANCOVA|Analysis of Covariance model included baseline value for the secondary endpoint measure, MMSE stratification (\>=20, \<20) at baseline and treatment.||Analysis of Covariance (ANCOVA)||-0.67|-3.65|0.005
71650305|NCT02788513|142819153|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.343|TWO_SIDED|95.0|-0.32|0.11||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.11|-0.32|0.343
71650306|NCT02788513|142819153|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.645|TWO_SIDED|95.0|-0.26|0.16||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.16|-0.26|0.645
71650307|NCT02788513|142819153|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.448|TWO_SIDED|95.0|-0.13|0.3||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.30|-0.13|0.448
71650308|NCT02788513|142819153|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.11|0.32||p-values are nominal without multiplicity adjustment.|ANCOVA|ANCOVA included MMSE stratification (\>=20, \<20) at baseline (BL) and treatment, CIBIS is included as BL adjustment term.||Analysis of Covariance (ANCOVA)||0.32|-0.11|0.340
71650309|NCT01976728|142819180|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.012||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||The primary efficacy analysis compared the pooled ovulation rate of the LutrePulse 15 μg and 20 μg group to placebo.||||0.0120
71739253|NCT03188510|142991280|OTHER||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.805|1.17||||||||1.17|0.805|
71650310|NCT01976728|142819181|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0553||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||P4 levels of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0553
71650311|NCT01976728|142819182|SUPERIORITY|The hypotheses was tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0383||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Clinical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0383
71650312|NCT01976728|142819183|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0246||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||Biochemical pregnancy rates of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0246
71650313|NCT01976728|142819184|SUPERIORITY|The hypotheses were tested using a stratified one-sided Fisher's exact test in the FAS including the randomization scheme as the stratification factor.||||||0.0011||||||The SAS PROC FREQ with permutation-based Cochran-Mantel-Haenszel test with exact p-value derived from all possible permutations was employed for the calculation of p-value for the stratified Fisher's exact test.|Fisher Exact|The success threshold at each analysis corresponded to a nominal p-value \<0.0130 to maintain an overall one-sided type I error rate of 0.025.||LH surge detection of the pooled LutrePulse 15 μg and 20 μg group were compared to placebo.||||0.0011
71650314|NCT01976728|142819185|SUPERIORITY|||||||0.1344||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1344
71650315|NCT01976728|142819185|SUPERIORITY|||||||0.2726||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2726
71650316|NCT01976728|142819185|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 10: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
71650317|NCT01976728|142819185|SUPERIORITY|||||||0.1275||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1275
71650318|NCT01976728|142819185|SUPERIORITY|||||||0.1088||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1088
71650319|NCT01976728|142819185|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
71650320|NCT01976728|142819185|SUPERIORITY|||||||0.0796||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.0796
71650321|NCT01976728|142819185|SUPERIORITY|||||||0.1757||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test||||0.1757
71650322|NCT01976728|142819185|SUPERIORITY|||||||0.0584||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0584
71650323|NCT01976728|142819185|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
71650324|NCT01976728|142819185|SUPERIORITY|||||||0.0143||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0143
71739254|NCT03188510|142991280|OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.841|1.22||||||||1.22|0.841|
71650325|NCT01976728|142819185|SUPERIORITY|||||||0.006||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0060
71650326|NCT01976728|142819185|SUPERIORITY|||||||0.1573||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥14 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.1573
71650327|NCT01976728|142819186|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 12: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
71650328|NCT01976728|142819186|SUPERIORITY|||||||0.2374||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2374
71650329|NCT01976728|142819186|SUPERIORITY|||||||0.2636||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.2636
71650330|NCT01976728|142819186|SUPERIORITY|||||||0.4795||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4795
71650331|NCT01976728|142819186|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 15: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
71650332|NCT01976728|142819186|SUPERIORITY|||||||0.3711||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3711
71650333|NCT01976728|142819186|SUPERIORITY|||||||0.4142||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.4142
71650334|NCT01976728|142819186|SUPERIORITY|||||||0.0838||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 18: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 20 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.0838
71650335|NCT01976728|142819186|SUPERIORITY|||||||0.3173||||||The p-value was based on the stratified (by randomization scheme) Wilcoxon rank sum test.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 10 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3173
71650336|NCT01976728|142819186|SUPERIORITY|||||||0.3778||||||The p-value was based on the Wilcoxon rank sum test without stratification.|Wilcoxon rank sum test|SAS PROC FREQ with modified ridit score (MODRIDIT option) was used for the stratified Wilcoxon rank sum test.||Day 21: Number of follicles with a mean diameter ≥18 mm in the LutrePulse 15 μg group was compared to placebo, using Wilcoxon's rank sum test.||||0.3778
71650337|NCT01976728|142819187|SUPERIORITY||Least square mean (LSM) difference|1.35||||0.6732|TWO_SIDED|95.0|-5.16|7.87||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% confidence interval (CI) for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 10 µg group were compared to placebo using an analysis of covariance (ANCOVA) model including the randomization scheme and treatment group as factors and baseline value as covariate.||7.87|-5.16|0.6732
71650338|NCT01976728|142819187|SUPERIORITY||LSM|5.7||||0.0814|TWO_SIDED|95.0|-0.76|12.15||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||12.15|-0.76|0.0814
71739255|NCT03188510|142991280|OTHER||Ratio of geometric least squares means|0.985|||||TWO_SIDED|90.0|0.819|1.18||||||||1.18|0.819|
71739256|NCT03188510|142991281|OTHER||Ratio of geometric least squares means|0.978|||||TWO_SIDED|90.0|0.811|1.18||||||||1.18|0.811|
71739257|NCT03188510|142991281|OTHER||Ratio of geometric least squares means|1.0|||||TWO_SIDED|90.0|0.833|1.21||||||||1.21|0.833|
71739258|NCT03188510|142991281|OTHER||Ratio of geometric least squares means|0.982|||||TWO_SIDED|90.0|0.817|1.18||||||||1.18|0.817|
71739259|NCT03139344|142991283|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71739260|NCT03139344|142991283|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71739261|NCT03139344|142991284|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71739262|NCT03139344|142991284|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71739263|NCT03139344|142991285|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
71650339|NCT01976728|142819187|SUPERIORITY||LSM difference|7.55||||0.0223|TWO_SIDED|95.0|1.16|13.93||p-value for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Maximum P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||13.93|1.16|0.0223
71650340|NCT01976728|142819188|SUPERIORITY||LSM difference|0.679||||0.7355|TWO_SIDED|95.0|-3.404|4.762||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 10 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||4.762|-3.404|0.7355
71650341|NCT01976728|142819188|SUPERIORITY||LSM difference|2.602||||0.198|TWO_SIDED|95.0|-1.444|6.648||p-value for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 15 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 15 µg group were compared to placebo using an ANCOVA model including treatment group as factors and baseline value as covariate.||6.648|-1.444|0.1980
71650342|NCT01976728|142819188|SUPERIORITY||LSM difference|4.88||||0.0187|TWO_SIDED|95.0|0.878|8.882||p-value for the LutrePulse 10 µg group compared to placebo based on the fitted linear model were reported.|ANCOVA|PROC GLM was used for ANCOVA.|The LSM difference on the treatment groups and 95% CI for the LutrePulse 20 µg group compared to placebo based on the fitted linear model were reported. Type III sum-of-squares for the LSMs were used for statistical comparisons.|Mean P4 levels in the LutrePulse 20 µg group were compared to placebo using an ANCOVA model including the randomization scheme and treatment group as factors and baseline value as covariate.||8.882|0.878|0.0187
71650343|NCT01976728|142819189|SUPERIORITY||LSM difference|0.03||||0.8772|TWO_SIDED|95.0|-0.39|0.46||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.46|-0.39|0.8772
71650344|NCT01976728|142819189|SUPERIORITY||LSM difference|0.07||||0.7805|TWO_SIDED|95.0|-0.44|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.44|0.7805
71650345|NCT01976728|142819189|SUPERIORITY||LSM difference|0.12||||0.6095|TWO_SIDED|95.0|-0.35|0.58||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in FSH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||0.58|-0.35|0.6095
71650346|NCT01976728|142819190|SUPERIORITY||LSM difference|0.51||||0.152|TWO_SIDED|95.0|-0.2|1.22||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.22|-0.20|0.1520
71650347|NCT01976728|142819190|SUPERIORITY||LSM difference|0.93||||0.0221|TWO_SIDED|95.0|0.14|1.72||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.72|0.14|0.0221
71650348|NCT01976728|142819190|SUPERIORITY||LSM difference|0.76||||0.0316|TWO_SIDED|95.0|0.07|1.44||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in LH levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||1.44|0.07|0.0316
71650349|NCT01976728|142819192|SUPERIORITY||LSM difference|73.0||||0.3147|TWO_SIDED|95.0|-72.66|218.65||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 10 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||218.65|-72.66|0.3147
71739264|NCT03139344|142991285|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71739265|NCT03139344|142991286|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
71739266|NCT03139344|142991286|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
71739267|NCT03139344|142991287|SUPERIORITY|||||||0.069|||||||ANOVA|||||||0.069
71739268|NCT03139344|142991287|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
71886457|NCT00848354|143293337|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).||||<0.0001
71650350|NCT01976728|142819192|SUPERIORITY||LSM difference|95.18||||0.229|TWO_SIDED|95.0|-63.01|253.36||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 15 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||253.36|-63.01|0.2290
71650351|NCT01976728|142819192|SUPERIORITY||LSM difference|46.99||||0.5066|TWO_SIDED|95.0|-95.64|189.61||The p-value was derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|ANCOVA||LSM difference and CIs were derived from an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.|The mean change in E2 levels from Day 10 pre-treatment (prior to first dose) in the LutrePulse 20 μg/Pulse group was compared to placebo using an ANCOVA model with randomization scheme and treatment as factors and baseline value as covariate.||189.61|-95.64|0.5066
71650352|NCT00966381|142819199|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71650353|NCT00966381|142819200|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71650354|NCT00966381|142819201|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71650355|NCT04894084|142819230|SUPERIORITY||Risk Ratio (RR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.49|||Poisson loglinear model|||||0.49|0.07|<0.001
71650356|NCT04894084|142819231|OTHER||Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0||"Low degree + Very low degree / Not at all were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."||99|72|<0.0001
71650357|NCT04894084|142819232|OTHER||Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0||"Some degree, High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For reliability answered on a 5-point scale the answers some, high, or very high degree was considered acceptable and grouped against answers of 'low or very low' degree of reliability.||93|56|0.0106
71650358|NCT04894084|142819233|OTHER||Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0||"Same, Better and Much better were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||For secondary endpoints an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. For ability to move with test product it was tested if the proportion evaluating same or better was significantly different from 50% when using a 5% test level. The answers of 'same, better or much better' was grouped against the answers of 'worse or much worse' ability to move.||100|78|<0.0001
71650359|NCT04894084|142819234|OTHER|Users worry of leakage given on a 5-point scale was analyzed by a proportional odds ratio model taken the paired design into consideration to compare the results from V1 and V2.|||||<|0.001|||||||Proportional odds ratio model|||||||<0.001
71650360|NCT04894084|142819235|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
71650361|NCT04894084|142819236|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|65.2||||0.21|TWO_SIDED|95.0|43.0|84.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||84|43|0.21
71650362|NCT04894084|142819237|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|78.3||||0.0106|TWO_SIDED|95.0|56.0|93.0|||Exact test in the binomial distribution|||||93|56|0.0106
71650363|NCT04894084|142819238|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|69.6||||0.093|TWO_SIDED|95.0|47.0|87.0|||Exact test in the binomial distribution|||||87|47|0.093
71650364|NCT04894084|142819239|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion with a positive response was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|95.7|||<|0.0001|TWO_SIDED|95.0|78.0|100.0|||Exact test in the binomial distribution|||||100|78|<0.0001
71739269|NCT03139344|142991288|SUPERIORITY|||||||0.118|||||||ANOVA|||||||0.118
71650365|NCT04894084|142819240|OTHER|By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion answering I felt more confident was significantly different from 50% when using a 5% test level.|Exact test in the binomial distribution|91.3|||<|0.0001|TWO_SIDED|95.0|72.0|99.0|||Exact test in the binomial distribution|||||99|72|<0.0001
71650366|NCT04894084|142819241|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|34.8||||0.21|TWO_SIDED|95.0|16.0|57.0||"Yes, to the better was tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||57|16|0.21
71650367|NCT04894084|142819242|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|47.8||||1|TWO_SIDED|95.0|27.0|69.0||"Higher degree and Much higher degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||69|27|1.00
71650368|NCT04894084|142819243|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|56.5||||0.678|TWO_SIDED|95.0|34.0|77.0|||Exact test in the binomial distribution|||||77|34|0.678
71650369|NCT04894084|142819245|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level. For questions answered on a 5-point scale the answers was grouped in 2 (e.g. higher or much higher against the rest of the answers)."|Exact test in the binomial distribution|69.6||||0.0931|TWO_SIDED|95.0|47.0|87.0||"High degree and Very high degree were tested against the rest of the answers in this analysis."|Exact test in the binomial distribution|||||87|47|0.0931
71650370|NCT04894084|142819246|OTHER|"For secondary endpoints where the possible answer is Yes or No, the proportion of subjects answering Yes was calculated. By use of an exact test in the binomial distribution a 95% confidence interval was estimated for the proportion. It was tested if the proportion was significantly different from 50% when using a 5% test level."|Exact test in the binomial distribution|87.0||||0.0005|TWO_SIDED|95.0|66.0|97.0|||Exact test in the binomial distribution|||||97|66|0.0005
71650371|NCT00317642|142819251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.78|1.28|||Log Rank|||Full Analysis Set (FAS) population||1.28|0.78|0.9951
71650372|NCT00317642|142819251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4674|TWO_SIDED|95.0|0.81|1.57|||Log Rank|||Participants stratified by calculated strata remission after first pre-study induction regimen (CR1) \< 6 months||1.57|0.81|0.4674
71650373|NCT00317642|142819251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3963|TWO_SIDED|95.0|0.58|1.24|||Log Rank|||Participants stratified by calculated strata CR1\>= 6 months||1.24|0.58|0.3963
71650374|NCT00317642|142819252|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - overall remission (OR)||||<0.0001
71650375|NCT00317642|142819252|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - Complete Remission (CR)||||0.0005
71650376|NCT00317642|142819252|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Overall Remission (CR+CRi)\]||||0.0022
71650377|NCT00317642|142819252|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Overall Remission (CR+CRi)\]||||0.0019
71738849|NCT02106403|142990597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.8711|TWO_SIDED|95.0|-5.35|6.31|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||6.31|-5.35|0.8711
71650378|NCT00317642|142819252|SUPERIORITY_OR_OTHER|||||||0.0353||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \<6 months \[Complete Remission (CR)\]||||0.0353
71650379|NCT00317642|142819252|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Fisher Exact|||Participants stratified by calculated strata - CR1 \>=6 months \[Complete Remission (CR)\]||||0.0096
71650380|NCT00317642|142819257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0001|TWO_SIDED|95.0|0.49|0.8|||Log Rank|||Full Analysis Set (FAS) population.||0.80|0.49|0.0001
71650381|NCT00317642|142819257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.0131|TWO_SIDED|95.0|0.49|0.93|||Log Rank|Comparison P-value is from a log-rank test with no strata||Participants stratified by randomization strata CR1 \<6 months||0.93|0.49|0.0131
71650382|NCT00317642|142819257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.0022||95.0|0.4|0.83|||Log Rank|Comparison p-value is from a log-rank test with no strata.||Participants stratified by randomization strata CR1 \>=6 months||0.83|0.40|0.0022
71650383|NCT00317642|142819258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8209|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||Full Analysis Set (FAS) population||1.23|0.77|0.8209
71650384|NCT00317642|142819258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5071|TWO_SIDED|95.0|0.81|1.53|||Log Rank|||||1.53|0.81|0.5071
71650385|NCT00317642|142819258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.2906|TWO_SIDED|95.0|0.59|1.17|||Log Rank|||||1.17|0.59|0.2906
71650386|NCT00317642|142819259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||Full Analysis Set (FAS) population.||0.79|0.49|<.0001
71650387|NCT00317642|142819259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0486|TWO_SIDED|95.0|0.53|1.01|||Log Rank|||||1.01|0.53|0.0486
71650388|NCT00317642|142819259|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||||0.74|0.37|0.0002
71650389|NCT00317642|142819260|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population||||<0.0001
71650390|NCT00317642|142819260|SUPERIORITY_OR_OTHER|||||||0.0088||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \<6 months.||||0.0088
71650391|NCT00317642|142819260|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Fisher Exact|||Participants stratified by randomization strata CR1 \>=6 months||||0.0017
71650392|NCT00317642|142819261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71650393|NCT00317642|142819261|SUPERIORITY_OR_OTHER|||||||0.0506||95.0|||||Fisher Exact|||||||0.0506
71650394|NCT00317642|142819261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71650395|NCT01049412|142819264|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.81|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.81|<0.001
71650396|NCT01049412|142819265|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.56|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|90.0|-0.83|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.29|-0.83|<0.001
71650397|NCT01049412|142819266|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.242|TWO_SIDED|90.0|-0.28|0.05||The statistical significance level is 0.10.|Mixed Models Analysis|||||0.05|-0.28|0.242
71650398|NCT01049412|142819267|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c \<7.0%."|Fisher Exact|||||||0.276
71650399|NCT01049412|142819267|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%."|Fisher Exact|||||||0.119
71650400|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|0.3|STANDARD_ERROR_OF_MEAN|0.35||0.392|TWO_SIDED|90.0|-0.28|0.88||"The statistical significance level is 0.10.~P-value is for 0300 hour BG."|Mixed Models Analysis|||||0.88|-0.28|0.392
71650401|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.24|STANDARD_ERROR_OF_MEAN|0.33||0.464|TWO_SIDED|90.0|-0.79|0.3||"The statistical significance level is 0.10.~P-value is for morning FBG."|Mixed Models Analysis|||||0.30|-0.79|0.464
71650402|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.48|STANDARD_ERROR_OF_MEAN|0.33||0.151|TWO_SIDED|90.0|-1.04|0.07||"The statistical significance level is 0.10.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis|||||0.07|-1.04|0.151
71650403|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.54|STANDARD_ERROR_OF_MEAN|0.3||0.079|TWO_SIDED|90.0|-1.05|-0.03||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis|||||-0.03|-1.05|0.079
71650404|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.52|STANDARD_ERROR_OF_MEAN|0.28||0.07|TWO_SIDED|90.0|-0.99|-0.05||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis|||||-0.05|-0.99|0.070
71650405|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.86|STANDARD_ERROR_OF_MEAN|0.32||0.008|TWO_SIDED|90.0|-1.39|-0.34||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG."|Mixed Models Analysis|||||-0.34|-1.39|0.008
71650406|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.89|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|90.0|-1.38|-0.41||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis|||||-0.41|-1.38|0.003
71650407|NCT01049412|142819269|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-1.1|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|90.0|-1.64|-0.55||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis|||||-0.55|-1.64|0.001
71650408|NCT01049412|142819274|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||The statistical significance level is 0.10.|Negative Binomial Model|||||||0.037
71650409|NCT01049412|142819275|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Final)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|90.0|-0.69|-0.25||The statistical significance level is 0.10.|Mixed Models Analysis|||||-0.25|-0.69|<0.001
71650410|NCT00693225|142819287|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71650411|NCT01315028|142819290|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71650412|NCT01315028|142819291|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANOVA|||Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.||||0.996
71650413|NCT01315028|142819292|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71650414|NCT01315028|142819293|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71650415|NCT01077817|142819304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.||1.5|0.7|
71650416|NCT01077817|142819304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.||2.0|0.9|
71650417|NCT01077817|142819304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.9|||||TWO_SIDED|95.0|1.4|16.7|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.||16.7|1.4|
71650418|NCT01077817|142819304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|1.0|2.5|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.||2.5|1.0|
71650419|NCT01077817|142819304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.2|||Logistic Regression Model|The case-cohort hazard ratio estimate for drug exposure was based on analysis of all cases of esophageal cancer and their comparison sample.||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.||2.2|0.2|
71650420|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||1.3|0.7|
71650421|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.8|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.8|
71650422|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.5|3.4|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate~compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||3.4|0.5|
71650423|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate~compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.0|0.9|
71650424|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."||2.3|0.3|
71739270|NCT03139344|142991288|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
71739271|NCT03139344|142991289|SUPERIORITY|||||||0.059|||||||ANOVA|||||||0.059
71739272|NCT03139344|142991289|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
71739273|NCT03139344|142991290|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.010
71739274|NCT03139344|142991290|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
71824387|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|1.0|9.1|||||RD is for retention 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||9.1|1|
71650425|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.5|0.7|
71650426|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|1.9|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||1.9|0.7|
71650427|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.0|||||TWO_SIDED|95.0|0.8|11.1|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||11.1|0.8|
71650428|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8|||||TWO_SIDED|95.0|1.1|3.0|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||3.0|1.1|
71650429|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.1|2.7|||Proportional Hazards Regression Model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."||2.7|0.1|
71650430|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.6|||Proportional Hazards Regression Model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||1.6|0.5|
71650431|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.|Proportional hazards regression model|||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.0|0.6|
71650432|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.4|2.5|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate~compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||2.5|0.4|
71650433|NCT01077817|142819305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|3.9|||Proportional hazards regression model|Year of birth, calendar quarter of cohort entry, and exposure history were stratified in this model.||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."||3.9|0.2|
71650434|NCT03750695|142819307|OTHER||||||<|0.05|||||||Regression, Linear|||Repeated measures linear regression||||<0.05
71650435|NCT00108550|142819342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0305|STANDARD_ERROR_OF_MEAN|0.038||0.4237|TWO_SIDED|95.0|-0.044|0.105||There was no need for multiple comparisons adjustment for the primary outcome, since there was only one. However, secondary analyses were adjusted for multiple comparisons.|Mixed Models Analysis|Effect of covariates (age, gender, etc) was evaluated (modeled as fixed effects) in secondary analyses.|The analysis was performed on transformed (rather than raw) Descriptor Differential Score Pain Intensity scores.|The null hypothesis was that Gabapentin is no better than placebo in reducing back pain. A mean-matching variance stabilizing transformation was applied to Descriptor Differential Scale Pain intensity (DDS) scores. Scores were modeled as a function of time (week) and group (gabapentin, placebo) in a mixed effects model. Random (subject-specific)intercept and slopes were fitted to the data. With alpha = .05 and N = 65 per group power is .8 to detect effect size =.4 standard deviations (SD).||0.105|-0.044|0.4237
71650436|NCT00108550|142819343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5343|STANDARD_ERROR_OF_MEAN|0.7174||0.458|TWO_SIDED|95.0|-1.94|0.872||Primary analyses was multivariable linear regression with fixed and random effects. After the Bonferroni adjustment a p-value would have been considered significant at 0.05 level if \<0.01.|Mixed Models Analysis|||This is a secondary analysis; the null hypothesis is that Gabapentin performs no better than placebo in reducing the Roland and Morris score.||0.872|-1.940|0.458
71739275|NCT03139344|142991291|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
71739276|NCT03139344|142991292|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
71739277|NCT03139344|142991293|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
71739278|NCT03139344|142991294|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
71650437|NCT05103657|142819369|OTHER||Mean Difference (Net)|0.06||||0.9726|TWO_SIDED|95.0|-3.31|3.43|||Mixed Models for repeated measures||"Least Squares mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Squares (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||3.43|-3.31|0.9726
71650438|NCT05103657|142819370|OTHER||Odds Ratio (OR)|1.002||||0.9945|TWO_SIDED|95.0|0.608|1.65|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.650|0.608|0.9945
71650439|NCT05103657|142819371|OTHER||Odds Ratio (OR)|0.912||||0.7167|TWO_SIDED|95.0|0.552|1.504|||Regression, Logistic||BI 1358894 125 mg vs. Placebo|Logistic regression was adjusted for fixed factors of treatment and presence of significant childhood trauma (yes vs. no).||1.504|0.552|0.7167
71650440|NCT05103657|142819372|OTHER||Mean Difference (Net)|0.66||||0.723|TWO_SIDED|95.0|-3.0|4.32|||Mixed Models for Repeated Measures||"Least Square mean of BI 1358894 125 mg - Least Square mean of Placebo."|Least Square (LS) means differences and confidence intervals were estimated by REML-based MMRM including the fixed categorical covariates of treatment, and the stratification indicator of presence of significant childhood trauma (yes vs. no), the continuous fixed covariate of baseline CAPS-5 total severity score, time since index event (in years) and the treatment-by-visit interaction. Patient is considered as random. Unstructured covariance matrix was used.||4.32|-3.00|0.7230
71650441|NCT00476593|142819382|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|95.0||||Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.|t-test, 2 sided|The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender||Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group||||0.018
71650442|NCT00476593|142819382|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||t-test, 2 sided|||Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.||||0.024
71650443|NCT03635983|142819383|SUPERIORITY||Estimate of Odds Ratio (OR)|0.66||||0.0311|TWO_SIDED|95.0|0.45|0.96|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||0.96|0.45|0.0311
71650444|NCT03635983|142819384|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3988||95.0|0.89|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.89|0.3988
71650445|NCT03635983|142819385|SUPERIORITY|Bempegaldesleukin+Nivolumab over Nivolumab|Hazard Ratio (HR)|0.94||||0.6361|TWO_SIDED|95.0|0.72|1.22|||Log Rank|2-sided p-value. Boundary for statistical significance p-value \< 0.00071|Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab.|||1.22|0.72|0.6361
71650446|NCT03635983|142819389|SUPERIORITY||Estimate of Odds Ratio (OR)|0.7||||0.0626|TWO_SIDED|95.0|0.48|1.02|||Stratified Cochran-Mantel-Haenszel|two-sided|Strata adjusted odds ratio (NKTR-214 + Nivolumab over Nivolumab) using Mantel-Haenszel method.|Bempegaldesleukin+Nivolumab over Nivolumab||1.02|0.48|0.0626
71650447|NCT03635983|142819390|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3713||95.0|0.9|1.33||Log-rank stratified 2-sided. Boundary for statistical significance p-value \< 0.03|Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is NKTR-214 + Nivolumab over Nivolumab|||1.33|0.90|0.3713
71650448|NCT03635983|142819394|SUPERIORITY||Odds Ratio (OR)|0.63||||||95.0|0.32|1.24|||||Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Negative: \<1%)||1.24|0.32|
71650449|NCT03635983|142819394|SUPERIORITY||Odds Ratio (OR)|0.63||||0.9939|TWO_SIDED|95.0|0.39|1.02|||Stratified Cochran-Mantel-Haenszel|Interaction P-value|Logistic regression model with treatment, PD-L1 Status and treatment by PD-L1 Status interaction. Responders includes CR+PR|Bempegaldesleukin+Nivolumab vs. Nivolumab (PD-L1 Positive: \>=1%)||1.02|0.39|0.9939
71650450|NCT03635983|142819395|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.43|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.43|0.81|
71650451|NCT03635983|142819395|SUPERIORITY||Hazard Ratio (HR)|1.12||||||95.0|0.83|1.51|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.51|0.83|
71886458|NCT00848354|143293339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.||||<0.0001
71650452|NCT03635983|142819396|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.66|1.4|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 negative: \<1%)||1.40|0.66|
71650453|NCT03635983|142819396|SUPERIORITY||Hazard Ratio (HR)|0.88||||||95.0|0.58|1.33|||||Unstratified Hazard Ratio|Bempegaldesleukin+Nivolumab vs. Nivo (PD-L1 positive: \>=1%)||1.33|0.58|
71650454|NCT01235442|142819454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.46|2.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI(=\<35 or \>35) and prior anti-TNF exposure(Yes or no).||||2.87|1.46|<0.001
71650455|NCT01235442|142819455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.4|2.75||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.75|1.40|<0.001
71739279|NCT03139344|142991295|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
71650456|NCT01235442|142819456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.009|TWO_SIDED|95.0|1.21|2.64||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||2.64|1.21|0.009
71650457|NCT01235442|142819457|SUPERIORITY_OR_OTHER|||||||0.006||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No) with with modified ridit scores.||||||0.006
71650458|NCT01235442|142819458|SUPERIORITY_OR_OTHER||||||<|0.001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|van Elteren test|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||||<0.001
71650459|NCT01235442|142819459|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.135|TWO_SIDED|95.0|0.92|1.85||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is adjusted for baseline BMI (=\<35 or \>35) and prior anti-TNF (Yes or No).||||1.85|0.92|0.135
71650460|NCT01235442|142819460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.135|TWO_SIDED|95.0|0.96|1.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=\<35 or \>35) and prior anti-TNF exposure (Yes or No).||||1.87|0.96|0.135
71650461|NCT03712124|142819472|OTHER||Least Square (LS) Mean Difference|-6.44||||0.903|TWO_SIDED|95.0|-116.18|103.31|||ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with change from baseline at Day 14 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||103.31|-116.18|0.9030
71650462|NCT03712124|142819473|OTHER||LS Mean Difference|98.45||||0.0042|TWO_SIDED|95.0|35.81|161.08|||ANCOVA|||Analysis was performed using ANCOVA model with change from baseline at Day 28 as the dependent variable and baseline maximum tolerated volume and treatment as covariates.||161.08|35.81|0.0042
71650463|NCT04718129|142819510|SUPERIORITY||Mean Difference (Net)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.048|TWO_SIDED|95.0|0.003|0.085|||Regression, Linear|||||.085|.003|.048
71650464|NCT02030535|142819525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.187|0.252||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation|Tio+Olo 5/5μg minus Placebo.|||0.252|0.187|<0.0001
71650465|NCT02030535|142819525|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.252|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.22|0.284||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward-Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within-patient variation.|Tiotropium 5μg + Olodaterol 5μg minus Placebo.|||0.284|0.220|<0.0001
71650466|NCT02030535|142819525|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.033|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.065|-0.001|||||Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.|Descriptive comparison. Statistical Analyses 1 \& 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)||-0.001|-0.065|
71650467|NCT00292227|142819543|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.75||||||90.0|-2.63|1.12|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.12|-2.63|
71650468|NCT00292227|142819544|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.01||||||90.0|-2.21|2.19|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.19|-2.21|
71650469|NCT00292227|142819545|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.84||||||90.0|-1.12|2.8|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.80|-1.12|
71650470|NCT00292227|142819546|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.26||||||90.0|-1.8|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.80|
71650471|NCT00292227|142819547|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.11||||||90.0|-2.25|2.02|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.02|-2.25|
71650472|NCT00292227|142819548|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.07||||||90.0|-2.14|2.28|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.28|-2.14|
71650473|NCT00292227|142819549|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.56||||||90.0|-2.84|1.72|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.72|-2.84|
71650474|NCT00292227|142819550|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.26||||||90.0|-2.29|1.78|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.78|-2.29|
71650475|NCT00292227|142819551|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.17||||||90.0|-3.25|0.91|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.91|-3.25|
71650476|NCT00292227|142819552|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.69||||||90.0|-0.34|3.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.73|-0.34|
71650477|NCT00292227|142819553|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.31||||||90.0|-1.7|2.32|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.32|-1.70|
71650478|NCT00292227|142819554|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.65||||||90.0|-0.65|3.96|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.96|-0.65|
71650479|NCT00292227|142819555|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.21||||||90.0|-1.78|1.36|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.36|-1.78|
71739280|NCT03139344|142991296|SUPERIORITY|||||||0.109|||||||t-test, 2 sided|||||||0.109
71739281|NCT03139344|142991297|SUPERIORITY|||||||0.895|||||||t-test, 2 sided|||||||0.895
71739282|NCT03139344|142991298|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|paired t-test||||||0.573
71650480|NCT00292227|142819556|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.53||||||90.0|-2.37|1.3|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.30|-2.37|
71650481|NCT00292227|142819557|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.41||||||90.0|-2.3|1.49|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.49|-2.30|
71650482|NCT00292227|142819558|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.5||||||90.0|-2.34|1.35|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.35|-2.34|
71650483|NCT00292227|142819559|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.21||||||90.0|-1.76|2.17|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.17|-1.76|
71650484|NCT00292227|142819560|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.23||||||90.0|-2.99|0.53|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.53|-2.99|
71650485|NCT00292227|142819561|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.62||||||90.0|-3.87|0.63|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.63|-3.87|
71650486|NCT00292227|142819562|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.81||||||90.0|-2.55|0.93|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||0.93|-2.55|
71650487|NCT00292227|142819563|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.37||||||90.0|-2.13|1.39|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.39|-2.13|
71739283|NCT03139344|142991299|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|paired t-test||||||0.858
71886459|NCT00848354|143293339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.||||<0.0001
71886460|NCT00848354|143293339|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0002
71650488|NCT00292227|142819564|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.68||||||90.0|-2.6|1.25|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.25|-2.60|
71650489|NCT00292227|142819565|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.17||||||90.0|-0.69|3.03|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||3.03|-0.69|
71650490|NCT00292227|142819566|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.8||||||90.0|-1.14|2.73|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||2.73|-1.14|
71650491|NCT00292227|142819567|NON_INFERIORITY_OR_EQUIVALENCE|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.42||||||90.0|-2.33|1.5|||ANCOVA|The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.|The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.||1.50|-2.33|
71650492|NCT00292227|142819568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||||95.0|-1.04|1.71|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.71|-1.04|
71650493|NCT00292227|142819569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||||95.0|-0.72|1.68|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||1.68|-0.72|
71650494|NCT00292227|142819570|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.51||||||95.0|0.3|2.73|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||2.73|0.30|
71650495|NCT00292227|142819571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.5||||||95.0|11.78|15.22|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||15.22|11.78|
71650496|NCT00292227|142819572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.02||||||95.0|9.12|12.93|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.93|9.12|
71738850|NCT02106403|142990598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.43||||0.0016|TWO_SIDED|95.0|4.43|18.42|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.42|4.43|0.0016
71738851|NCT02106403|142990598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.69||||0.6323|TWO_SIDED|95.0|-5.31|8.69|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.69|-5.31|0.6323
71886461|NCT00848354|143293339|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.||||0.0007
71702463|NCT01047501|142921895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-6.2||||0.0067|TWO_SIDED|95.0|-10.5|-1.7|||Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.||-1.7|-10.5|0.0067
71702464|NCT01047501|142921895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo with a significance level of 0.05. Non-inferiority tests for percent change from baseline in LDL-C were performed between AMR101 and placebo to determine if AMR101 was statistically non-inferior to placebo with regard to increases in LDL-C. The pre-specified LDL-C criterion for noninferiority was the upper boundary 97.5% confidence interval not crossing the +6% threshold.|Median Difference (Final Values)|-3.6||||0.0867|TWO_SIDED|95.0|-7.9|0.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||0.5|-7.9|0.0867
71702465|NCT01047501|142921896|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0001|TWO_SIDED|95.0|-17.2|-9.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-9.9|-17.2|0.0001
71702466|NCT01047501|142921896|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.5||||0.014|TWO_SIDED|95.0|-9.4|-1.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.7|-9.4|0.0140
71739284|NCT03052049|142991302|OTHER|t-test|p value|0.05||||0.05|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.05
71650497|NCT00292227|142819573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.3||||||95.0|9.94|12.67|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||12.67|9.94|
71650498|NCT00292227|142819574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.28||||||95.0|6.85|9.7|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.70|6.85|
71650499|NCT00292227|142819575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||||95.0|7.57|11.02|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||11.02|7.57|
71650500|NCT00292227|142819576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.87||||||95.0|7.47|10.28|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||10.28|7.47|
71650501|NCT00292227|142819577|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.6||||||95.0|7.25|9.96|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||9.96|7.25|
71739285|NCT03052049|142991303|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71739286|NCT03052049|142991304|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71650502|NCT00292227|142819578|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.52||||||95.0|6.31|8.72|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.72|6.31|
71650503|NCT00292227|142819579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.58||||||95.0|6.21|8.95|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||8.95|6.21|
71650504|NCT00292227|142819580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.19||||||95.0|4.94|7.45|||ANOVA|The ANOVA model included the factors treatment, period, sequence, and subject(sequence).|The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.||7.45|4.94|
71650505|NCT00442546|142819590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.691|-0.766|0.9185
71650506|NCT00442546|142819590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p\<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference|||0.392|-1.070|0.3619
71650507|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.065|STANDARD_ERROR_OF_MEAN|19.426||0.4091||95.0|-54.332|22.203|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.203|-54.332|0.4091
71650508|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.548|STANDARD_ERROR_OF_MEAN|19.388||0.4234||95.0|-53.74|22.645|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||22.645|-53.740|0.4234
71650509|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.428|STANDARD_ERROR_OF_MEAN|16.517||0.0284||95.0|-68.972|-3.884|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||-3.884|-68.972|0.0284
71650510|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-28.985|STANDARD_ERROR_OF_MEAN|16.57||0.0816||95.0|-61.632|3.663|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||3.663|-61.632|0.0816
71650511|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.759|STANDARD_ERROR_OF_MEAN|11.752||0.8147||95.0|-20.446|25.964|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||25.964|-20.446|0.8147
71650512|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.182|STANDARD_ERROR_OF_MEAN|11.589||0.7187||95.0|-27.064|18.7|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||18.700|-27.064|0.7187
71650513|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.356|STANDARD_ERROR_OF_MEAN|10.148||0.7416||95.0|-23.516|16.804|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||16.804|-23.516|0.7416
71650514|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.574|STANDARD_ERROR_OF_MEAN|9.283||0.2577||95.0|-29.017|7.869|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||7.869|-29.017|0.2577
71650515|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|17.387||0.9982||95.0|-36.431|36.352|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||36.352|-36.431|0.9982
71650516|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.325|STANDARD_ERROR_OF_MEAN|22.184||0.5552||95.0|-59.756|33.107|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||33.107|-59.756|0.5552
71650517|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|STANDARD_ERROR_OF_MEAN|24.655||0.2032||95.0|-118.463|38.463|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||38.463|-118.463|0.2032
71650518|NCT00442546|142819591|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-138.5|STANDARD_ERROR_OF_MEAN|37.661||0.0348||95.0|-258.354|-18.646|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours||-18.646|-258.354|0.0348
71650519|NCT00442546|142819592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.136|STANDARD_ERROR_OF_MEAN|4.499||0.3602||95.0|-4.79|13.062|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||13.062|-4.790|0.3602
71650520|NCT00442546|142819592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.573|STANDARD_ERROR_OF_MEAN|4.637||0.7352||95.0|-7.626|10.771|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2||10.771|-7.626|0.7352
71650521|NCT00442546|142819592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|6.156||0.6435||95.0|-9.392|15.111|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.111|-9.392|0.6435
71739287|NCT03052049|142991305|OTHER|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71739288|NCT03052049|142991306|SUPERIORITY|||||||0.05||||||P value was calculated and a value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.05
71824388|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.8|1.6|||||RD is for transfer 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||1.6|-0.8|
71824389|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for transfer 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
71824390|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-1.7|0.7|||||RD is for transfer 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.7|-1.7|
71824391|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||RD is for death 3MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.2|-0.4|
71824392|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.9|0.8|||||RD is for death 6MD vs. SOC.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.8|-0.9|
71886462|NCT00848354|143293339|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0001
71886463|NCT00848354|143293339|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.||||<0.0001
71886464|NCT00848354|143293339|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0021
71650522|NCT00442546|142819592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.237|STANDARD_ERROR_OF_MEAN|6.361||0.6123||95.0|-9.422|15.895|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4||15.895|-9.422|0.6123
71886465|NCT00848354|143293340|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0001
71650523|NCT00442546|142819592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|7.663||0.6356||95.0|-11.683|18.984|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||18.984|-11.683|0.6356
71650524|NCT00442546|142819592|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|7.747||0.907||95.0|-14.593|16.411|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET||16.411|-14.593|0.9070
71650525|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1190.65|STANDARD_ERROR_OF_MEAN|123.062||0.0656||95.0|-2754.304|373.004|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||373.004|-2754.304|0.0656
71650526|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|142.1||0.9277||95.0|-1789.352|1821.752|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours||1821.752|-1789.352|0.9277
71650527|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|62.692||0.935||95.0|-263.972|275.515|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||275.515|-263.972|0.9350
71650528|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.243|STANDARD_ERROR_OF_MEAN|44.33||0.6139||95.0|-164.494|216.98|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours||216.980|-164.494|0.6139
71650529|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|9.96||0.776||95.0|-25.451|19.611|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||19.611|-25.451|0.7760
71650530|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|6.833||0.819||95.0|-17.066|13.846|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours||13.846|-17.066|0.8190
71650531|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.235|STANDARD_ERROR_OF_MEAN|390.483||0.8603||95.0|-861.171|722.7|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||722.700|-861.171|0.8603
71650532|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.395|STANDARD_ERROR_OF_MEAN|384.376||0.9642||95.0|-796.945|762.155|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours||762.155|-796.945|0.9642
71650533|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|93.693|STANDARD_ERROR_OF_MEAN|484.957||0.8476||95.0|-880.865|1068.251|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1068.251|-880.865|0.8476
71650534|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.543|STANDARD_ERROR_OF_MEAN|457.374||0.8185||95.0|-813.584|1024.67|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours||1024.670|-813.584|0.8185
71650535|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-682.304|STANDARD_ERROR_OF_MEAN|495.241||0.1792||95.0|-1696.759|332.15|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||332.150|-1696.759|0.1792
71650536|NCT00442546|142819593|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-250.439|STANDARD_ERROR_OF_MEAN|501.808||0.6216||95.0|-1278.347|777.469|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours||777.469|-1278.347|0.6216
71650537|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-494.0|STANDARD_ERROR_OF_MEAN|301.253||0.1996||95.0|-1452.72|464.72|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||464.720|-1452.720|0.1996
71650538|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-195.15|STANDARD_ERROR_OF_MEAN|368.958||0.6335||95.0|-1369.338|979.038|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.||979.038|-1369.338|0.6335
71650539|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.291|STANDARD_ERROR_OF_MEAN|302.355||0.929||95.0|-657.992|603.41|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||603.410|-657.992|0.9290
71650540|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.787|STANDARD_ERROR_OF_MEAN|256.969||0.8937||95.0|-501.241|570.815|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2||570.815|-501.241|0.8937
71650541|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|198.937|STANDARD_ERROR_OF_MEAN|491.153||0.6912||95.0|-847.93|1245.804|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||1245.804|-847.930|0.6912
71650542|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|185.728|STANDARD_ERROR_OF_MEAN|349.047||0.6024||95.0|-558.248|929.704|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4||929.704|-558.248|0.6024
71650543|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-256.921|STANDARD_ERROR_OF_MEAN|407.391||0.5372||95.0|-1120.551|606.709|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||606.709|-1120.551|0.5372
71650544|NCT00442546|142819594|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-287.032|STANDARD_ERROR_OF_MEAN|328.227||0.3948||95.0|-982.843|408.778|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET||408.778|-982.843|0.3948
71650545|NCT00442546|142819595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-121.5|STANDARD_ERROR_OF_MEAN|1169.654||0.9341|TWO_SIDED|95.0|-14983.36|14740.362|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||14740.362|-14983.36|0.9341
71650546|NCT00442546|142819597|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|302.9|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|302.9|302.9|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|||302.900|302.900|<0.0001
71650547|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.087||0.1661||95.0|-0.293|0.051|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.051|-0.293|0.1661
71650548|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.088||0.3604||95.0|-0.254|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.093|-0.254|0.3604
71650549|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.083||0.1299||95.0|-0.29|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.037|-0.290|0.1299
71650550|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.129|STANDARD_ERROR_OF_MEAN|0.082||0.1167||95.0|-0.29|0.032|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.032|-0.290|0.1167
71650551|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.09||0.5271||95.0|-0.234|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.234|0.5271
71650552|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.09||0.6731||95.0|-0.215|0.139|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.139|-0.215|0.6731
71650553|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.098||0.5936||95.0|-0.247|0.142|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.142|-0.247|0.5936
71650554|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.094||0.8368||95.0|-0.206|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.167|-0.206|0.8368
71650555|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.111||0.8659||95.0|-0.242|0.204|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.204|-0.242|0.8659
71650556|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.112||0.7151||95.0|-0.266|0.184|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.184|-0.266|0.7151
71650557|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.077||0.2121||95.0|-0.249|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.056|-0.249|0.2121
71650558|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.077||0.5607||95.0|-0.197|0.107|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.107|-0.197|0.5607
71650559|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.077||0.7797||95.0|-0.13|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.173|-0.130|0.7797
71650560|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.079||0.8761||95.0|-0.143|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.167|-0.143|0.8761
71650561|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.067||0.8619||95.0|-0.121|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.144|-0.121|0.8619
71650562|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.068||0.7256||95.0|-0.111|0.159|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.159|-0.111|0.7256
71650563|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8659||95.0|-0.11|0.131|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.131|-0.110|0.8659
71650564|NCT00442546|142819601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.063||0.0203||95.0|0.023|0.27|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.270|0.023|0.0203
71650565|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5791||95.0|-0.187|0.105|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.105|-0.187|0.5791
71650566|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.075||0.6829||95.0|-0.178|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.117|-0.178|0.6829
71650567|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.07||0.4516||95.0|-0.19|0.085|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.085|-0.190|0.4516
71650568|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.071|STANDARD_ERROR_OF_MEAN|0.069||0.3014||95.0|-0.207|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.064|-0.207|0.3014
71650569|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.075||0.7628||95.0|-0.171|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.125|-0.171|0.7628
71650570|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.075||0.711||95.0|-0.176|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.120|-0.176|0.7110
71650571|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.079||0.7382||95.0|-0.183|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.130|-0.183|0.7382
71650572|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.076||0.6586||95.0|-0.183|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.116|-0.183|0.6586
71650573|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.084||0.7691||95.0|-0.195|0.145|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.145|-0.195|0.7691
71650574|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.085||0.507||95.0|-0.229|0.115|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.115|-0.229|0.5070
71650575|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.066||0.5802||95.0|-0.166|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.093|-0.166|0.5802
71650576|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.065||0.919||95.0|-0.122|0.136|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.136|-0.122|0.9190
71650577|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.059||0.6559||95.0|-0.09|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.143|-0.090|0.6559
71650578|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.06||0.8552||95.0|-0.108|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.130|-0.108|0.8552
71650579|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.048||0.6364||95.0|-0.072|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.117|-0.072|0.6364
71650580|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.049||0.2127||95.0|-0.035|0.157|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.157|-0.035|0.2127
71650581|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.047||0.8746||95.0|-0.086|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.101|-0.086|0.8746
71650582|NCT00442546|142819602|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.048||0.0286||95.0|0.011|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.202|0.011|0.0286
71650583|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165|STANDARD_ERROR_OF_MEAN|0.102||0.1078||95.0|-0.367|0.036|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.036|-0.367|0.1078
71650584|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.103||0.6406||95.0|-0.252|0.155|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.155|-0.252|0.6406
71650585|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.092||0.2404||95.0|-0.289|0.073|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.073|-0.289|0.2404
71650586|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.09||0.1005||95.0|-0.327|0.029|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.029|-0.327|0.1005
71650587|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.136|STANDARD_ERROR_OF_MEAN|0.108||0.2109||95.0|-0.349|0.078|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.078|-0.349|0.2109
71650588|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.108||0.2399||95.0|-0.342|0.086|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.086|-0.342|0.2399
71650589|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.131|STANDARD_ERROR_OF_MEAN|0.108||0.2272||95.0|-0.346|0.083|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.083|-0.346|0.2272
71650590|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.4417||95.0|-0.285|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.125|-0.285|0.4417
71650591|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.144||0.9502||95.0|-0.299|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.281|-0.299|0.9502
71650592|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.144||0.355||95.0|-0.426|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.156|-0.426|0.3550
71650593|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.092||0.1888||95.0|-0.304|0.06|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.060|-0.304|0.1888
71650594|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.092||0.3774||95.0|-0.262|0.1|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.100|-0.262|0.3774
71650595|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.087||0.9452||95.0|-0.178|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.166|-0.178|0.9452
71650596|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.089||0.7663||95.0|-0.201|0.148|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.148|-0.201|0.7663
71650597|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.074||0.5777||95.0|-0.104|0.186|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.186|-0.104|0.5777
71650598|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.075||0.2916||95.0|-0.069|0.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.227|-0.069|0.2916
71650599|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.069||0.8389||95.0|-0.15|0.122|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.122|-0.150|0.8389
71650600|NCT00442546|142819603|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.07||0.0734||95.0|-0.012|0.266|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.266|-0.012|0.0734
71650601|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1949||95.0|-0.276|0.057|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.057|-0.276|0.1949
71650602|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.085||0.5431||95.0|-0.22|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.116|-0.220|0.5431
71650603|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.077||0.2164||95.0|-0.247|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.056|-0.247|0.2164
71650604|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.076||0.1251||95.0|-0.266|0.033|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.033|-0.266|0.1251
71650605|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.088||0.4079||95.0|-0.247|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.101|-0.247|0.4079
71650606|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.088||0.4562||95.0|-0.24|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.108|-0.240|0.4562
71650607|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.093||0.4526||95.0|-0.254|0.114|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.114|-0.254|0.4526
71650608|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.089||0.6186||95.0|-0.221|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.132|-0.221|0.6186
71650609|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.109||0.8712||95.0|-0.237|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.202|-0.237|0.8712
71650610|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.11||0.4784||95.0|-0.3|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.143|-0.300|0.4784
71702467|NCT01047501|142921897|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-24.4||||0.0001|TWO_SIDED|95.0|-31.9|-17.0||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-17.0|-31.9|0.0001
71650611|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.075||0.2635||95.0|-0.232|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.064|-0.232|0.2635
71650612|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.075||0.6009||95.0|-0.187|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.108|-0.187|0.6009
71650613|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.073||0.8559||95.0|-0.13|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.156|-0.130|0.8559
71650614|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.074||0.9841||95.0|-0.147|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.144|-0.147|0.9841
71650615|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.061||0.6771||95.0|-0.095|0.146|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.146|-0.095|0.6771
71650616|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.062||0.3717||95.0|-0.067|0.178|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.178|-0.067|0.3717
71650617|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.058||0.9863||95.0|-0.114|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.116|-0.114|0.9863
71650618|NCT00442546|142819604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.059||0.0355||95.0|0.009|0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.243|0.009|0.0355
71650619|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.202||0.8071||95.0|-0.35|0.449|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.449|-0.350|0.8071
71702468|NCT01047501|142921897|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.5||||0.017|TWO_SIDED|95.0|-18.3|-2.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-2.5|-18.3|0.0170
71650620|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.204||0.8282||95.0|-0.359|0.447|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.447|-0.359|0.8282
71650621|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.192||0.8972||95.0|-0.353|0.403|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.403|-0.353|0.8972
71650622|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.19||0.8159||95.0|-0.329|0.418|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.418|-0.329|0.8159
71650623|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.188||0.8577||95.0|-0.337|0.405|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.405|-0.337|0.8577
71650624|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.188||0.8158||95.0|-0.415|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-0.415|0.8158
71650625|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.195||0.4243||95.0|-0.229|0.541|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.541|-0.229|0.4243
71650626|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.205|STANDARD_ERROR_OF_MEAN|0.187||0.2742||95.0|-0.164|0.574|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||0.574|-0.164|0.2742
71650627|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.116||0.5569||95.0|-0.302|0.165|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.165|-0.302|0.5569
71738852|NCT02106403|142990598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.73||||0.0069|TWO_SIDED|95.0|2.74|16.73|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||16.73|2.74|0.0069
71650628|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.116||0.3762||95.0|-0.13|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||0.336|-0.130|0.3762
71650629|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.155||0.6203||95.0|-0.229|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.383|-0.229|0.6203
71650630|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.155||0.3343||95.0|-0.155|0.455|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.455|-0.155|0.3343
71650631|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.128||0.2213||95.0|-0.096|0.41|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.410|-0.096|0.2213
71650632|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.131||0.2863||95.0|-0.118|0.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.399|-0.118|0.2863
71650633|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.082||0.305||95.0|-0.077|0.245|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.245|-0.077|0.3050
71650634|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.083||0.0155||95.0|0.039|0.368|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.368|0.039|0.0155
71650635|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.087||0.9243||95.0|-0.164|0.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.181|-0.164|0.9243
71650636|NCT00442546|142819605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.089||0.0201||95.0|0.033|0.386|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.386|0.033|0.0201
71650637|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.321||0.1537||95.0|-1.093|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.173|-1.093|0.1537
71650638|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.398|STANDARD_ERROR_OF_MEAN|0.324||0.2208||95.0|-1.038|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.241|-1.038|0.2208
71650639|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.325||0.8355||95.0|-0.707|0.572|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.572|-0.707|0.8355
71650640|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.331||0.5024||95.0|-0.875|0.43|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.430|-0.875|0.5024
71650641|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.282||0.8116||95.0|-0.489|0.624|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.624|-0.489|0.8116
71650642|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.288||0.7325||95.0|-0.667|0.469|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.469|-0.667|0.7325
71650643|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.278||0.8133||95.0|-0.614|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.614|0.8133
71650644|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.285||0.9307||95.0|-0.588|0.538|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.538|-0.588|0.9307
71650645|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.439||0.2682||95.0|-1.364|0.385|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.385|-1.364|0.2682
71650646|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.294|STANDARD_ERROR_OF_MEAN|0.413||0.4784||95.0|-1.116|0.528|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.528|-1.116|0.4784
71650647|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.661|STANDARD_ERROR_OF_MEAN|0.298||0.0255||95.0|0.084|1.239|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.239|0.084|0.0255
71650648|NCT00442546|142819606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.448|STANDARD_ERROR_OF_MEAN|0.314||0.1591||95.0|-0.18|1.076|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.076|-0.180|0.1591
71650649|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.372||0.0359||95.0|-1.52|-0.052|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.052|-1.520|0.0359
71650650|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.907|STANDARD_ERROR_OF_MEAN|0.374||0.0161||95.0|-1.644|-0.17|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.170|-1.644|0.0161
71650651|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.319||0.7416||95.0|-0.733|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.523|-0.733|0.7416
71650652|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.324||0.3527||95.0|-0.939|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.336|-0.939|0.3527
71702469|NCT01047501|142921898|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.0||||0.0001|TWO_SIDED|95.0|-22.2|-15.7||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-15.7|-22.2|0.0001
71650653|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.184|STANDARD_ERROR_OF_MEAN|0.3||0.5419||95.0|-0.776|0.409|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.409|-0.776|0.5419
71650654|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.305||0.9333||95.0|-0.628|0.577|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.577|-0.628|0.9333
71650655|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.354|STANDARD_ERROR_OF_MEAN|0.24||0.142||95.0|-0.827|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.120|-0.827|0.1420
71650656|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.245||0.829||95.0|-0.535|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.429|-0.535|0.8290
71650657|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.111|STANDARD_ERROR_OF_MEAN|0.441||0.0138||95.0|-1.989|-0.233|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||-0.233|-1.989|0.0138
71650658|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.416||0.23||95.0|-1.332|0.325|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.325|-1.332|0.2300
71650659|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.268||0.5151||95.0|-0.36|0.711|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||0.711|-0.360|0.5151
71650660|NCT00442546|142819607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.433|STANDARD_ERROR_OF_MEAN|0.295||0.146||95.0|-0.155|1.022|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.022|-0.155|0.1460
71650661|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258|STANDARD_ERROR_OF_MEAN|0.463||0.5786||95.0|-1.17|0.655|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.655|-1.170|0.5786
71650662|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.467||0.957||95.0|-0.895|0.946|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.946|-0.895|0.9570
71650663|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.434||0.986||95.0|-0.862|0.847|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.847|-0.862|0.9860
71650664|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.151|STANDARD_ERROR_OF_MEAN|0.442||0.7336||95.0|-1.021|0.72|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.720|-1.021|0.7336
71650665|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.384|STANDARD_ERROR_OF_MEAN|0.365||0.2939||95.0|-0.336|1.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.104|-0.336|0.2939
71650666|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.372||0.4615||95.0|-0.459|1.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.008|-0.459|0.4615
71886466|NCT00848354|143293340|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
71650667|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.347||0.6433||95.0|-0.845|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.523|-0.845|0.6433
71650668|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.356||0.9466||95.0|-0.678|0.726|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.726|-0.678|0.9466
71650669|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.424|STANDARD_ERROR_OF_MEAN|0.621||0.4967||95.0|-1.66|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.812|-1.660|0.4967
71650670|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.582||0.8659||95.0|-1.06|1.257|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.257|-1.060|0.8659
71650671|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.994|STANDARD_ERROR_OF_MEAN|0.451||0.0311||95.0|0.093|1.895|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.895|0.093|0.0311
71702470|NCT01047501|142921898|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.0||||0.0004|TWO_SIDED|95.0|-11.6|-4.5|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-4.5|-11.6|0.0004
71650672|NCT00442546|142819608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.995|STANDARD_ERROR_OF_MEAN|0.485||0.0441||95.0|0.027|1.962|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.962|0.027|0.0441
71650673|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.969|STANDARD_ERROR_OF_MEAN|0.439||0.0284||95.0|-1.835|-0.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.104|-1.835|0.0284
71650674|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.444||0.5516||95.0|-1.141|0.611|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.611|-1.141|0.5516
71650675|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.38||0.479||95.0|-1.02|0.48|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.480|-1.020|0.4790
71650676|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.39||0.9947||95.0|-0.765|0.77|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.770|-0.765|0.9947
71650677|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.329||0.8943||95.0|-0.605|0.692|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.692|-0.605|0.8943
71650678|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.336||0.9767||95.0|-0.674|0.654|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.654|-0.674|0.9767
71650679|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.34||0.8117||95.0|-0.59|0.752|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.752|-0.590|0.8117
71650680|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.125|STANDARD_ERROR_OF_MEAN|0.351||0.7216||95.0|-0.818|0.567|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.567|-0.818|0.7216
71650681|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.592||0.8558||95.0|-1.286|1.07|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.070|-1.286|0.8558
71650682|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.422|STANDARD_ERROR_OF_MEAN|0.556||0.4501||95.0|-1.53|0.685|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.685|-1.530|0.4501
71650683|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.328|STANDARD_ERROR_OF_MEAN|0.45||0.4682||95.0|-0.57|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.570|0.4682
71650684|NCT00442546|142819609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.492||0.5347||95.0|-0.675|1.289|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.289|-0.675|0.5347
71650685|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.407||0.0613||95.0|-1.568|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.037|-1.568|0.0613
71650686|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.936|STANDARD_ERROR_OF_MEAN|0.409||0.023||95.0|-1.741|-0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||-0.130|-1.741|0.0230
71650687|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.4||0.8306||95.0|-0.703|0.875|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.875|-0.703|0.8306
71650688|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.439|STANDARD_ERROR_OF_MEAN|0.407||0.2814||95.0|-1.242|0.363|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.363|-1.242|0.2814
71650689|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.353||0.8637||95.0|-0.636|0.757|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.757|-0.636|0.8637
71650690|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.359||0.9585||95.0|-0.727|0.689|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.689|-0.727|0.9585
71650691|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.272|STANDARD_ERROR_OF_MEAN|0.321||0.3975||95.0|-0.906|0.361|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.361|-0.906|0.3975
71650692|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.327||0.6386||95.0|-0.799|0.491|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.491|-0.799|0.6386
71650693|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.702|STANDARD_ERROR_OF_MEAN|0.397||0.0813||95.0|-1.493|0.089|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.089|-1.493|0.0813
71650694|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.37||0.31||95.0|-1.114|0.358|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.358|-1.114|0.3100
71650695|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.831|STANDARD_ERROR_OF_MEAN|0.357||0.0231||95.0|0.118|1.545|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.545|0.118|0.0231
71824393|NCT03101592|143152773|NON_INFERIORITY|We estimated that approximately 5% of subjects would fail to be retained in care in the standard of care arm, and a retention rate \<7·5% to be non-inferior in the three-month or six-month study arms, with a 2·5% non-inferiority margin. Assuming an alpha of 0.05, power of 90%, and an intracluster correlation coefficient (ICC) of 0·004, we estimated a sample size of 271 subjects per cluster for a total of 2,710 subjects per arm and 8,130 total individuals.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||RD is for death 6MD vs. 3MD.|Our sample size was estimated for a cluster-randomized non-inferiority trial. We had 30 clusters available for randomization and assumed a fixed number of clusters (k), an equal number of clusters per arm, and an equal number of subjects per cluster.||0.3|-0.3|
71650696|NCT00442546|142819610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.463|STANDARD_ERROR_OF_MEAN|0.388||0.2367||95.0|-0.311|1.237|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.237|-0.311|0.2367
71650697|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.448||0.8868||95.0|-0.947|0.82|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.820|-0.947|0.8868
71650698|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.254|STANDARD_ERROR_OF_MEAN|0.45||0.5733||95.0|-1.142|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.634|-1.142|0.5733
71650699|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.384||0.7385||95.0|-0.884|0.628|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.628|-0.884|0.7385
71650700|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.39||0.8353||95.0|-0.849|0.687|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.687|-0.849|0.8353
71650701|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.362||0.5737||95.0|-0.51|0.918|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.918|-0.510|0.5737
71650702|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.335|STANDARD_ERROR_OF_MEAN|0.368||0.364||95.0|-1.06|0.391|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.391|-1.060|0.3640
71650703|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.332||0.4315||95.0|-0.393|0.917|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.917|-0.393|0.4315
71650704|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.339||0.6727||95.0|-0.525|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.812|-0.525|0.6727
71650705|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.489|STANDARD_ERROR_OF_MEAN|0.505||0.3361||95.0|-1.496|0.517|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.517|-1.496|0.3361
71650706|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.469||0.9634||95.0|-0.955|0.912|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.912|-0.955|0.9634
71650707|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.446|STANDARD_ERROR_OF_MEAN|0.352||0.2098||95.0|-0.257|1.15|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.150|-0.257|0.2098
71650708|NCT00442546|142819611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.382||0.49||95.0|-0.497|1.027|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.027|-0.497|0.4900
71650709|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.546||0.9912||95.0|-1.07|1.082|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||1.082|-1.070|0.9912
71824394|NCT01770860|143152777|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
71824395|NCT01770860|143152778|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
71650710|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.554||0.8076||95.0|-1.227|0.957|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.957|-1.227|0.8076
71650711|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.46||0.6978||95.0|-0.727|1.085|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.085|-0.727|0.6978
71650712|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.47||0.5344||95.0|-1.219|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.634|-1.219|0.5344
71650713|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.384||0.8721||95.0|-0.819|0.695|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.695|-0.819|0.8721
71650714|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.394||0.3179||95.0|-1.173|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.383|-1.173|0.3179
71886467|NCT00848354|143293340|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0003
71650715|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.376||0.8037||95.0|-0.648|0.835|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.835|-0.648|0.8037
71702471|NCT01047501|142921899|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-12.3|-6.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.1|-12.3|0.0001
71702472|NCT01047501|142921899|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-3.8||||0.017|TWO_SIDED|95.0|-6.9|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-6.9|0.0170
71702473|NCT00063622|142921953|SUPERIORITY_OR_OTHER|||||||0.001||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.001
71702474|NCT00063622|142921953|SUPERIORITY_OR_OTHER|||||||0.04||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.||||0.04
71824396|NCT01770860|143152779|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
71824397|NCT01770860|143152780|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.||||||<0.0001
71824398|NCT01770860|143152781|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect||||||0.0476
71650716|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7731||95.0|-0.656|0.881|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.881|-0.656|0.7731
71650717|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.468|STANDARD_ERROR_OF_MEAN|0.611||0.4461||95.0|-1.684|0.748|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.748|-1.684|0.4461
71650718|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.575||0.3568||95.0|-1.679|0.612|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.612|-1.679|0.3568
71650719|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.598|STANDARD_ERROR_OF_MEAN|0.315||0.0623||95.0|-0.032|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.227|-0.032|0.0623
71650720|NCT00442546|142819612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.343||0.3529||95.0|-0.364|1.005|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.005|-0.364|0.3529
71650721|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.611|STANDARD_ERROR_OF_MEAN|0.417||0.1448||95.0|-1.434|0.212|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.212|-1.434|0.1448
71702475|NCT00063622|142921954|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.005
71824399|NCT02341534|143152784|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.21
71824400|NCT01648283|143152812|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71824401|NCT00601640|143152822|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
71702476|NCT00063622|142921954|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71702477|NCT00063622|142921955|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.02
71702478|NCT00063622|142921955|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
71702479|NCT00063622|142921956|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||||||0.01
71702480|NCT00063622|142921956|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
71702481|NCT00063622|142921957|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
71702482|NCT00063622|142921957|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
71702483|NCT00063622|142921958|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||||||0.05
71702484|NCT00063622|142921958|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
71702485|NCT04502524|142921959|OTHER|||||||0.999|||||||Fisher Exact|||For overall satisfaction, a reliable estimate could not be calculated using a logistic regression model as all the responses were the same in the Vet Flexiquit arm. We calculated the p-value using the Fisher's exact test.||||.999
71702486|NCT04502524|142921960|OTHER||Slope|0.05||||0.852|TWO_SIDED|95.0|-0.46|0.56|||Regression, negative binomial|||||0.56|-0.46|0.852
71702487|NCT04502524|142921961|OTHER||Slope|-0.44||||0.451|TWO_SIDED|95.0|-1.6|0.71|||Regression, negative binomial|||||0.71|-1.60|0.451
71702488|NCT04502524|142921962|OTHER||Slope|-0.73||||0.508|TWO_SIDED|95.0|-1.46|0.003|||Regression, negative binomial|||||0.003|-1.46|0.508
71702489|NCT04502524|142921963|OTHER||Odds Ratio (OR)|0.65||||0.602|TWO_SIDED|95.0|0.13|3.32|||Regression, Logistic|||||3.32|0.13|0.602
71702490|NCT04502524|142921964|OTHER||Odds Ratio (OR)|0.94||||0.941|TWO_SIDED|95.0|0.17|5.29|||Regression, Logistic|||||5.29|0.17|0.941
71702491|NCT04502524|142921965|OTHER||Odds Ratio (OR)|0.61||||0.612|TWO_SIDED|95.0|0.09|4.12|||Regression, Logistic|||||4.12|0.09|0.612
71702492|NCT04502524|142921966|OTHER||Slope|0.56||||0.504|TWO_SIDED|95.0|-1.13|2.26|||Regression, Linear|||||2.26|-1.13|0.504
71702493|NCT04502524|142921967|OTHER||Slope|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.61|||Regression, Linear|||||0.61|-0.40|0.670
71702494|NCT01018979|142921978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.023
71702495|NCT01018979|142921978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.||||0.038
71702496|NCT03010501|142921989|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
71702497|NCT03010501|142921990|SUPERIORITY|||||||0.1||||||According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.10
71702498|NCT03010501|142921990|SUPERIORITY|||||||0.15||||||According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.|Mixed Models Analysis|||||||0.15
71824402|NCT01112735|143152855|SUPERIORITY|||||||0.5621|||||||Wilcoxon (Mann-Whitney)|||||||0.5621
71702499|NCT03010501|142921991|SUPERIORITY||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis|||||||< 0.0001
71702500|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6346|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.6346
71702501|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2757|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.2757
71702502|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.1321
71702503|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5543|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.5543
71702504|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3940
71702505|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.7891
71702506|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.4829
71702507|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4526|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.4526
71702508|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.2485
71702509|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6252|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.6252
71702510|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4003|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.4003
71702511|NCT00544882|142922026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.8841
71702512|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8892|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.8892
71702513|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7678|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.7678
71702514|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.5782
71702515|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8083|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.8083
71702516|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||1.0000
71824403|NCT01112735|143152856|SUPERIORITY|||||||0.3595|||||||Wilcoxon (Mann-Whitney)|||||||0.3595
71824404|NCT01112735|143152857|SUPERIORITY|||||||0.9417|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9417
71702517|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4122|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.4122
71702518|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.||||0.6675
71702519|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8445|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.8445
71702520|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3772|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.||||0.3772
71702521|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.1918
71702522|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.||||0.6675
71702523|NCT00544882|142922028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9226|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.9226
71702524|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0979|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values \< 0.05 were considered statistically significant.||||0.0979
71702525|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.||||0.0629
71702526|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.||||0.8464
71702527|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6316|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.||||0.6316
71702528|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.||||0.3000
71702529|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.||||0.0955
71702530|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1523|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 25 time point.||||0.1523
71702531|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2809|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.||||0.2809
71702532|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 28 time point.||||0.8829
71702533|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9262|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.||||0.9262
71702534|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7811|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 -Day 4 time point.||||0.7811
71702535|NCT00544882|142922029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3703|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.||||0.3703
71702536|NCT03043573|142922035|SUPERIORITY||Mean Difference (Final Values)|-0.7011||||0.9644|TWO_SIDED|95.0|-31.8605|30.4583|||t-test, 2 sided|||Baseline||30.4583|-31.8605|0.9644
71702537|NCT03043573|142922035|SUPERIORITY||Mean Difference (Final Values)|2.4595||||0.888|TWO_SIDED|95.0|-32.3472|37.2661|||t-test, 2 sided|||Week 12||37.2661|-32.3472|0.8880
71702538|NCT03043573|142922035|SUPERIORITY||Mean Difference (Final Values)|-0.5119||||0.9773|TWO_SIDED|95.0|-36.5024|35.4785|||t-test, 2 sided|||Week 24||35.4785|-36.5024|0.9773
71702539|NCT03043573|142922035|SUPERIORITY||Mean Difference (Final Values)|15.6667||||0.6173|TWO_SIDED|95.0|-47.0598|78.3931|||t-test, 1 sided|||Week 52||78.3931|-47.0598|0.6173
71702540|NCT03043573|142922036|SUPERIORITY||Mean Difference (Final Values)|1.1302||||0.5454|TWO_SIDED|95.0|-2.5767|4.8371|||t-test, 2 sided|||Baseline||4.8371|-2.5767|0.5454
71762755|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.9161|TWO_SIDED|90.0|-1.24|1.09|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||1.09|-1.24|0.9161
71702541|NCT03043573|142922036|SUPERIORITY||Mean Difference (Final Values)|2.9618||||0.1212|TWO_SIDED|95.0|-0.8038|6.7275|||t-test, 2 sided|||Week 6||6.7275|-0.8038|0.1212
71702542|NCT03043573|142922036|SUPERIORITY||Mean Difference (Final Values)|1.095||||0.571|TWO_SIDED|95.0|-2.7476|4.9377|||t-test, 2 sided|||Week 12||4.9377|-2.7476|0.5710
71702543|NCT03043573|142922036|SUPERIORITY||Mean Difference (Final Values)|-1.5524||||0.4377|TWO_SIDED|95.0|-5.5256|2.4209|||t-test, 2 sided|||Week 24||2.4209|-5.5256|0.4377
71702544|NCT03043573|142922036|SUPERIORITY||Mean Difference (Final Values)|0.8937||||0.6813|TWO_SIDED|95.0|-3.4439|5.2312|||t-test, 2 sided|||Week 36||5.2312|-3.4439|0.6813
71702545|NCT03043573|142922036|SUPERIORITY||Mean Difference (Final Values)|2.9457||||0.162|TWO_SIDED|95.0|-1.2234|7.1148|||t-test, 2 sided|||||7.1148|-1.2234|0.1620
71702546|NCT03043573|142922037|SUPERIORITY||Mean Difference (Final Values)|0.0319||||0.9813|TWO_SIDED|95.0|-2.6668|2.7305|||t-test, 2 sided|||Baseline||2.7305|-2.6668|0.9813
71702547|NCT03043573|142922037|SUPERIORITY||Mean Difference (Final Values)|-0.0564||||0.9735|TWO_SIDED|95.0|-3.4397|3.3268|||t-test, 2 sided|||Week 6||3.3268|-3.4397|0.9735
71702548|NCT03043573|142922037|SUPERIORITY|Week 12|Mean Difference (Final Values)|1.0611||||0.5164|TWO_SIDED|95.0|-2.1885|4.3107|||t-test, 2 sided|||||4.3107|-2.1885|0.5164
71702549|NCT03043573|142922037|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.197|TWO_SIDED|95.0|-5.0651|1.0651|||t-test, 2 sided|||Week 24||1.0651|-5.0651|0.1970
71702550|NCT03043573|142922037|SUPERIORITY||Mean Difference (Net)|0.362||||0.8342|TWO_SIDED|95.0|-3.0907|3.8146|||t-test, 2 sided|||Week 36||3.8146|-3.0907|0.8342
71702551|NCT03043573|142922037|SUPERIORITY||Mean Difference (Final Values)|1.2667||||0.4717|TWO_SIDED|95.0|-2.2424|4.7758|||t-test, 2 sided|||Week 52||4.7758|-2.2424|0.4717
71702552|NCT03043573|142922038|SUPERIORITY||Mean Difference (Final Values)|-2.9318||||0.513|TWO_SIDED|95.0|-11.8176|5.9539|||t-test, 2 sided|||Baseline||5.9539|-11.8176|0.5130
71702553|NCT03043573|142922038|SUPERIORITY||Mean Difference (Final Values)|0.4835||||0.4835|TWO_SIDED|95.0|-15.2306|7.2967|||t-test, 2 sided|||Week 12||7.2967|-15.2306|0.4835
71762756|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-2.07||||0.0036|TWO_SIDED|90.0|-3.24|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||-0.91|-3.24|0.0036
71702554|NCT03043573|142922038|SUPERIORITY||Mean Difference (Final Values)|-5.156||||0.359|TWO_SIDED|95.0|-16.3357|6.0238|||t-test, 2 sided|||Week 24||6.0238|-16.3357|0.3590
71702555|NCT03043573|142922038|SUPERIORITY||Mean Difference (Final Values)|1.1083||||0.876|TWO_SIDED|95.0|-13.1598|15.3765|||t-test, 2 sided|||Week 52||15.3765|-13.1598|0.8760
71702556|NCT03043573|142922039|SUPERIORITY||Mean Difference (Final Values)|-0.0606||||0.3248|TWO_SIDED|95.0|-0.1841|0.0628|||t-test, 2 sided|||Trails A Baseline||0.0628|-0.1841|0.3248
71702557|NCT03043573|142922039|SUPERIORITY||Mean Difference (Final Values)|-0.6953||||0.3615|TWO_SIDED|95.0|-2.2261|0.8354|||t-test, 2 sided|||Trails A - Week 12||0.8354|-2.2261|0.3615
71702558|NCT03043573|142922039|SUPERIORITY||Mean Difference (Final Values)|0.9917||||0.5046|TWO_SIDED|95.0|-1.9664|3.9498|||t-test, 2 sided|||Trails B - Baseline||3.9498|-1.9664|0.5046
71702559|NCT03043573|142922039|SUPERIORITY||Mean Difference (Final Values)|-2.0607||||0.0679|TWO_SIDED|95.0|-4.2821|0.1607|||t-test, 2 sided|||Trails B - Week 12||0.1607|-4.2821|0.0679
71702560|NCT03043573|142922039|SUPERIORITY||Mean Difference (Final Values)|-0.8929||||0.1669|TWO_SIDED|95.0|-2.1825|0.3968|||t-test, 2 sided|||Trails B - Week 24||0.3968|-2.1825|0.1669
71702561|NCT03043573|142922039|SUPERIORITY||Mean Difference (Final Values)|-1.4286||||0.2178|TWO_SIDED|95.0|-3.8115|0.9543|||t-test, 2 sided|||Trails B - Week 52||0.9543|-3.8115|0.2178
71702562|NCT03043573|142922040|SUPERIORITY||Mean Difference (Final Values)|1.558||||0.2932|TWO_SIDED|95.0|-1.3747|4.4908|||t-test, 2 sided|||Baseline||4.4908|-1.3747|0.2932
71702563|NCT03043573|142922040|SUPERIORITY||Mean Difference (Final Values)|1.7043||||0.2871|TWO_SIDED|95.0|-1.4659|4.8744|||t-test, 2 sided|||Week 6||4.8744|-1.4659|0.2871
71702564|NCT03043573|142922040|SUPERIORITY||Mean Difference (Final Values)|0.9167||||0.591|TWO_SIDED|95.0|-2.4737|4.307|||t-test, 2 sided|||Week 12||4.3070|-2.4737|0.5910
71886468|NCT00848354|143293342|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
71702565|NCT03043573|142922040|SUPERIORITY||Mean Difference (Final Values)|-1.0238||||0.6128|TWO_SIDED|95.0|-5.0469|2.9993|||t-test, 2 sided|||||2.9993|-5.0469|0.6128
71702566|NCT03043573|142922040|SUPERIORITY||Mean Difference (Final Values)|1.9276||||0.3326|TWO_SIDED|95.0|-2.0231|5.8783|||t-test, 2 sided|||Week 36||5.8783|-2.0231|0.3326
71702567|NCT03043573|142922040|SUPERIORITY||Mean Difference (Final Values)|2.0741||||0.2935|TWO_SIDED|95.0|-1.8522|6.0004|||t-test, 2 sided|||Week 52||6.0004|-1.8522|0.2935
71702568|NCT01251861|142922044|SUPERIORITY|||||||0.28||||||one-sided|Fisher Exact|||||||0.28
71702569|NCT01251861|142922053|OTHER|The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.5||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and Gleason score (\<7, 7 vs. \>7) was evaluated by logistic regression with adjustment for treatment assignment.||||0.50
71702570|NCT01251861|142922054|OTHER|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.28||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||0.28
71702571|NCT00924651|142922086|OTHER||Mean Difference (Final Values)|-0.01916|STANDARD_ERROR_OF_MEAN|0.1791||0.9148|TWO_SIDED|95.0|-0.371|0.3327|||ANCOVA|||||0.3327|-0.3710|0.9148
71702572|NCT01991314|142922087|NON_INFERIORITY_OR_EQUIVALENCE|We calculated, on the premise that there is non-inferiority between adolescent and adult groups in the difference in increase of mean haemoglobin levels of 0.35g/dL, with estimated standard deviation 0.7g/dL following treatment, that 45 patients in each group would be required, derived using power 80% power, 1-sided significance level 0.05 and R 0.5 for the covariate; this calculation took into account planned ANCOVA methodology and 20% patients who might be lost to follow up or withdraw.|Mean Difference (Net)|0.08||||0.23|TWO_SIDED|||||To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA (one-tailed P\<0.05) was employed to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates|ANCOVA|||||||0.23
71702573|NCT01991314|142922088|SUPERIORITY_OR_OTHER||difference in proportions|3.6|||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test was used to compare proportions (expressed as percentages) of total number of participants in each group who were iron intolerant||Chi squared test or Fisher's exact test, as appropriate.||||<0.05
71702574|NCT01991314|142922089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0||||0.96|TWO_SIDED||||||t-test, 2 sided|||Unpaired Students t test||||0.96
71702575|NCT01991314|142922090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||0.49
71702576|NCT01991314|142922091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.85
71702577|NCT01991314|142922092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test||||0.69
71702578|NCT01991314|142922093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.9|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test||||<0.0001
71702579|NCT00879359|142922094|SUPERIORITY_OR_OTHER||Hazard Ratio, log|92.0|||||TWO_SIDED|95.0|64.0|99.0||||||||99|64|
71702580|NCT00970944|142922097|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||We will have 80% power to detect a one point difference in DRS score between the groups across the four week treatment window. With this sample size, we will be able to detect any unforeseen adverse events that have a prevalence of at least 2.5% in each group with 90% probability. With 92 patients per group we will be able to estimate the rate of adverse events to within ±10%.||||0.045
71739289|NCT00999518|142991307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.4|0.35||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).||0.35|-0.40|
71702581|NCT00970944|142922098|SUPERIORITY_OR_OTHER||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.088||0.007||95.0|-0.41|-0.07||The final analysis used a significance level of 0.045.|Mixed Models Analysis|Final analysis adjusted for early v. late enrollment relative to date of injury, baseline CRS-R rating category (MCS vs. VS), and site.||The planned sample size of 184 patients provided 80% power to detect a difference between the AH and placebo in the rate of Disability Rating Scale (DRS) score change of 0.3 points/week (1.22 DRS point mean difference by the end of the 4-week treatment interval). Two blinded interim analyses were conducted at 60 and 120 patients recruited using the O'Brien-Fleming boundary, with alpha levels of 0.0005 and 0.014. The final analysis used an alpha level of 0.045.||-0.07|-0.41|0.007
71702582|NCT03915067|142922105|SUPERIORITY||Rate Difference|65.8|||<|0.0001|TWO_SIDED|95.0|51.5|80.1||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||80.1|51.5|<0.0001
71702583|NCT03915067|142922105|SUPERIORITY||Rate Difference|76.2|||<|0.0001|TWO_SIDED|95.0|63.6|88.9||P-value derived from CMH model stratified by investigator site and C-APPS at Day 1.|Cochran-Mantel-Haenszel|||||88.9|63.6|<0.0001
71702584|NCT03915067|142922128|SUPERIORITY||Rate Difference|57.9|||<|0.0001|TWO_SIDED|95.0|42.3|73.5||P-value was derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||73.5|42.3|<0.0001
71702585|NCT03915067|142922128|SUPERIORITY||Rate Difference|70.2|||<|0.0001|TWO_SIDED|95.0|56.4|84.1||P-value derived from CMH model stratified by investigator site and P-APPS at Day 1.|Cochran-Mantel-Haenszel|||||84.1|56.4|<0.0001
71702586|NCT01033942|142922129|SUPERIORITY_OR_OTHER|||||||0.6983||||||The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.|Chi-squared|||||||0.6983
71702587|NCT01033942|142922130|SUPERIORITY_OR_OTHER|||||||0.8722|TWO_SIDED||||||Fisher Exact|||||||0.8722
71824405|NCT01112735|143152857|SUPERIORITY|||||||0.5488|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.5488
71702588|NCT01033942|142922131|SUPERIORITY_OR_OTHER|||||||0.6921||||||Not all subjects answered every question.|Fisher Exact|||||||0.6921
71702589|NCT01033942|142922132|SUPERIORITY_OR_OTHER|||||||0.4655||||||Not all participants answered every question|Fisher Exact|||||||0.4655
71702590|NCT01033942|142922133|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.9999
71702591|NCT01033942|142922134|SUPERIORITY_OR_OTHER|||||||0.2297|TWO_SIDED|||||Not all participants answered every question|Fisher Exact|||||||0.2297
71702592|NCT01033942|142922135|SUPERIORITY_OR_OTHER|||||||0.1886||||||Not all participants answered every question|Fisher Exact|||||||0.1886
71702593|NCT01033942|142922136|SUPERIORITY_OR_OTHER|||||||0.1908|||||||Fisher Exact|||||||0.1908
71702594|NCT01033942|142922137|SUPERIORITY_OR_OTHER|||||||0.224||||||Not all participants answered every question|Fisher Exact|||||||0.2240
71702595|NCT01033942|142922138|SUPERIORITY_OR_OTHER|||||||0.1538||||||Not all participants answered every question|Fisher Exact|||||||0.1538
71702596|NCT01033942|142922139|SUPERIORITY_OR_OTHER|||||||0.2151||||||Not all participants answered every question|Fisher Exact|||||||0.2151
71702597|NCT01033942|142922140|SUPERIORITY_OR_OTHER|||||||0.2809||||||Not all participants answered every question|Fisher Exact|||||||0.2809
71702598|NCT01033942|142922141|SUPERIORITY_OR_OTHER|||||||0.185||||||Not all participants answered every question|Fisher Exact|||||||0.1850
71702599|NCT01033942|142922142|SUPERIORITY_OR_OTHER|||||||0.2366||||||Not all participants answered every question|Fisher Exact|||||||0.2366
71702600|NCT01033942|142922143|SUPERIORITY_OR_OTHER|||||||0.4089||||||Not all subjects answered every question.|Fisher Exact|||||||0.4089
71702601|NCT01033942|142922144|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71824406|NCT01112735|143152857|SUPERIORITY|||||||0.7107|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.7107
71824407|NCT01112735|143152857|SUPERIORITY|||||||0.8809|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.8809
71702602|NCT01033942|142922145|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702603|NCT01033942|142922146|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702604|NCT01033942|142922147|SUPERIORITY_OR_OTHER|||||||0.7007|||||||Fisher Exact|||||||0.7007
71702605|NCT01033942|142922148|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702606|NCT01033942|142922149|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702607|NCT01033942|142922150|SUPERIORITY_OR_OTHER|||||||0.8934|||||||Chi-squared|||||||0.8934
71702608|NCT01033942|142922151|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702609|NCT01033942|142922152|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702610|NCT01033942|142922153|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED||||||Fisher Exact|||||||0.9999
71702611|NCT01033942|142922154|SUPERIORITY_OR_OTHER|||||||0.4003|||||||Fisher Exact|||||||0.4003
71702612|NCT01033942|142922155|SUPERIORITY_OR_OTHER|||||||0.6462|||||||Fisher Exact|||||||0.6462
71702613|NCT01033942|142922156|SUPERIORITY_OR_OTHER|||||||0.8505|||||||Chi-squared|||||||0.8505
71702614|NCT01033942|142922164|SUPERIORITY_OR_OTHER|||||||0.7434|TWO_SIDED||||||Chi-squared|||||||0.7434
71702615|NCT01033942|142922165|SUPERIORITY_OR_OTHER|||||||0.6153|TWO_SIDED||||||Chi-squared|||||||0.6153
71702616|NCT01033942|142922166|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||||||0.2000
71702617|NCT01033942|142922167|SUPERIORITY_OR_OTHER|||||||0.5265|TWO_SIDED||||||Chi-squared|||||||0.5265
71702618|NCT01033942|142922168|SUPERIORITY_OR_OTHER|||||||0.2559|TWO_SIDED||||||Chi-squared|||||||0.2559
71702619|NCT01033942|142922169|SUPERIORITY_OR_OTHER|||||||0.3846|TWO_SIDED||||||Chi-squared|||||||0.3846
71702620|NCT01033942|142922170|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||Chi-squared|||||||0.5133
71702621|NCT01033942|142922171|SUPERIORITY_OR_OTHER|||||||0.1661|TWO_SIDED||||||Chi-squared|||||||0.1661
71824408|NCT01112735|143152857|SUPERIORITY|||||||0.4598|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.4598
71824409|NCT01112735|143152857|SUPERIORITY|||||||0.3837|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.3837
71824410|NCT01112735|143152858|SUPERIORITY|||||||0.9699|||||||Wilcoxon (Mann-Whitney)|||Day 3||||0.9699
71824411|NCT01112735|143152858|SUPERIORITY|||||||0.4709|||||||Wilcoxon (Mann-Whitney)|||Day 7||||0.4709
71824412|NCT01112735|143152858|SUPERIORITY|||||||0.1406|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.1406
71702622|NCT01033942|142922172|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED||||||Chi-squared|||||||0.0729
71702623|NCT01033942|142922173|SUPERIORITY_OR_OTHER|||||||0.1912|TWO_SIDED||||||Chi-squared|||||||0.1912
71702624|NCT01033942|142922174|SUPERIORITY_OR_OTHER|||||||0.2829|TWO_SIDED||||||Chi-squared|||||||0.2829
71702625|NCT01033942|142922175|SUPERIORITY_OR_OTHER|||||||0.2685|TWO_SIDED||||||Chi-squared|||||||0.2685
71702626|NCT01033942|142922176|SUPERIORITY_OR_OTHER|||||||0.2342|TWO_SIDED||||||Chi-squared|||||||0.2342
71702627|NCT01033942|142922177|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Fisher Exact|||||||0.7314
71702628|NCT01033942|142922178|SUPERIORITY_OR_OTHER|||||||0.377|||||||Fisher Exact|||||||0.3770
71702629|NCT01033942|142922179|SUPERIORITY_OR_OTHER|||||||0.7004|||||||Fisher Exact|||||||0.7004
71702630|NCT01033942|142922180|SUPERIORITY_OR_OTHER|||||||0.4668|||||||Fisher Exact|||||||0.4668
71702631|NCT01033942|142922181|SUPERIORITY_OR_OTHER|||||||0.7573|||||||Fisher Exact|||||||0.7573
71702632|NCT01033942|142922182|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Fisher Exact|||||||0.0356
71702633|NCT01033942|142922183|SUPERIORITY_OR_OTHER|||||||0.3176|||||||Fisher Exact|||||||0.3176
71702634|NCT01033942|142922184|SUPERIORITY_OR_OTHER|||||||0.1348|||||||Fisher Exact|||||||0.1348
71702635|NCT01033942|142922185|SUPERIORITY_OR_OTHER|||||||0.042|||||||Fisher Exact|||||||0.0420
71702636|NCT01033942|142922186|SUPERIORITY_OR_OTHER|||||||0.4906|||||||Fisher Exact|||||||0.4906
71702637|NCT01033942|142922187|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Fisher Exact|||||||0.0544
71702638|NCT01033942|142922188|SUPERIORITY_OR_OTHER|||||||0.5645|||||||Fisher Exact|||||||0.5645
71702639|NCT01033942|142922189|SUPERIORITY_OR_OTHER|||||||0.7847|||||||Fisher Exact|||||||0.7847
71702640|NCT01033942|142922190|SUPERIORITY_OR_OTHER|||||||0.0288|||||||Fisher Exact|||||||0.0288
71702641|NCT01033942|142922191|SUPERIORITY_OR_OTHER|||||||0.0945|||||||Fisher Exact|||||||0.0945
71702642|NCT01033942|142922192|SUPERIORITY_OR_OTHER|||||||0.3884|||||||Fisher Exact|||||||0.3884
71702643|NCT01033942|142922193|SUPERIORITY_OR_OTHER|||||||0.2235|||||||Fisher Exact|||||||0.2235
71702644|NCT01033942|142922194|SUPERIORITY_OR_OTHER|||||||0.0467|||||||Fisher Exact|||||||0.0467
71702645|NCT01033942|142922195|SUPERIORITY_OR_OTHER|||||||0.6331|||||||Fisher Exact|||||||0.6331
71702646|NCT01033942|142922196|SUPERIORITY_OR_OTHER|||||||0.0948|||||||Fisher Exact|||||||0.0948
71702647|NCT01033942|142922197|SUPERIORITY_OR_OTHER|||||||0.5826|||||||Fisher Exact|||||||0.5826
71702648|NCT01033942|142922198|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Fisher Exact|||||||0.0087
71702649|NCT01033942|142922199|SUPERIORITY_OR_OTHER|||||||0.1934|||||||Fisher Exact|||||||0.1934
71702650|NCT01033942|142922200|SUPERIORITY_OR_OTHER|||||||0.2146|||||||Fisher Exact|||||||0.2146
71702651|NCT01033942|142922201|SUPERIORITY_OR_OTHER|||||||0.5317|||||||Fisher Exact|||||||0.5317
71702652|NCT01033942|142922202|SUPERIORITY_OR_OTHER|||||||0.1733|||||||Fisher Exact|||||||0.1733
71702653|NCT01033942|142922203|SUPERIORITY_OR_OTHER|||||||0.1747|||||||Fisher Exact|||||||0.1747
71702654|NCT01033942|142922204|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Fisher Exact|||||||0.1203
71702655|NCT01033942|142922205|SUPERIORITY_OR_OTHER|||||||0.8243|||||||Fisher Exact|||||||0.8243
71702656|NCT01033942|142922206|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Fisher Exact|||||||0.6202
71702657|NCT01033942|142922207|SUPERIORITY_OR_OTHER|||||||0.8351|||||||Fisher Exact|||||||0.8351
71702658|NCT01033942|142922208|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Fisher Exact|||||||0.0484
71702659|NCT01033942|142922209|SUPERIORITY_OR_OTHER|||||||0.4207|||||||Fisher Exact|||||||0.4207
71702660|NCT01033942|142922210|SUPERIORITY_OR_OTHER|||||||0.2187|||||||Fisher Exact|||||||0.2187
71702661|NCT01033942|142922211|SUPERIORITY_OR_OTHER|||||||0.5369|||||||Fisher Exact|||||||0.5369
71702662|NCT01033942|142922212|SUPERIORITY_OR_OTHER|||||||0.1524|||||||Fisher Exact|||||||0.1524
71702663|NCT01033942|142922213|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.4700
71702664|NCT01033942|142922214|SUPERIORITY_OR_OTHER|||||||0.4686|||||||Fisher Exact|||||||0.4686
71702665|NCT01033942|142922215|SUPERIORITY_OR_OTHER|||||||0.3791|||||||Fisher Exact|||||||0.3791
71702666|NCT01033942|142922216|SUPERIORITY_OR_OTHER|||||||0.7374|||||||Fisher Exact|||||||0.7374
71702667|NCT01033942|142922217|SUPERIORITY_OR_OTHER|||||||0.9363|||||||Fisher Exact|||||||0.9363
71702668|NCT01033942|142922218|SUPERIORITY_OR_OTHER|||||||0.6267|||||||Fisher Exact|||||||0.6267
71702669|NCT01033942|142922219|SUPERIORITY_OR_OTHER|||||||0.6434|TWO_SIDED||||||Fisher Exact|||||||0.6434
71702670|NCT01033942|142922220|SUPERIORITY_OR_OTHER|||||||0.8582|TWO_SIDED||||||Fisher Exact|||||||0.8582
71702671|NCT01033942|142922221|SUPERIORITY_OR_OTHER|||||||0.5778|TWO_SIDED||||||Fisher Exact|||||||0.5778
71702672|NCT01033942|142922222|SUPERIORITY_OR_OTHER|||||||0.9881|TWO_SIDED||||||Fisher Exact|||||||0.9881
71702673|NCT01033942|142922223|SUPERIORITY_OR_OTHER|||||||0.9771|TWO_SIDED||||||Fisher Exact|||||||0.9771
71702674|NCT01033942|142922224|SUPERIORITY_OR_OTHER|||||||0.2301|TWO_SIDED||||||Fisher Exact|||||||0.2301
71702675|NCT02260986|142922241|SUPERIORITY||difference in percentages|26.3|||<|0.0001|TWO_SIDED|95.0|16.34|36.26||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||36.26|16.34|<0.0001
71702676|NCT02260986|142922241|SUPERIORITY||difference in percentages|26.8|||<|0.0001|TWO_SIDED|95.0|20.33|33.28||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.||33.28|20.33|<0.0001
71739290|NCT00999518|142991307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.8|0.68||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.68|-0.80|
71824413|NCT01112735|143152858|SUPERIORITY|||||||0.4291|||||||Wilcoxon (Mann-Whitney)|||Day 28||||0.4291
71824414|NCT01112735|143152858|SUPERIORITY|||||||0.2704|||||||Wilcoxon (Mann-Whitney)|||Day 60||||0.2704
71702677|NCT02260986|142922242|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|45.7|||<|0.0001|TWO_SIDED|95.0|35.72|55.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.||55.66|35.72|<0.0001
71702678|NCT02260986|142922242|SUPERIORITY|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|40.8|||<|0.0001|TWO_SIDED|95.0|33.74|47.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.||47.81|33.74|<0.0001
71702679|NCT02260986|142922243|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|28.53|49.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||49.65|28.53|<0.0001
71702680|NCT02260986|142922243|SUPERIORITY||difference in percentages|31.1|||<|0.0001|TWO_SIDED|95.0|23.84|38.39||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||38.39|23.84|<0.0001
71702681|NCT02260986|142922244|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.56|48.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||48.31|27.56|<0.0001
71886469|NCT00848354|143293342|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0264
71650722|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.665|STANDARD_ERROR_OF_MEAN|0.42||0.1148||95.0|-1.494|0.163|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.163|-1.494|0.1148
71650723|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.448|STANDARD_ERROR_OF_MEAN|0.458||0.3285||95.0|-1.35|0.454|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.454|-1.350|0.3285
71650724|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.572|STANDARD_ERROR_OF_MEAN|0.466||0.2205||95.0|-1.49|0.346|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.346|-1.490|0.2205
71650725|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.389||0.6266||95.0|-0.958|0.578|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.578|-0.958|0.6266
71650726|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.502|STANDARD_ERROR_OF_MEAN|0.397||0.2077||95.0|-1.284|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.281|-1.284|0.2077
71650727|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.223|STANDARD_ERROR_OF_MEAN|0.385||0.5626||95.0|-0.982|0.536|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.536|-0.982|0.5626
71650728|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.368|STANDARD_ERROR_OF_MEAN|0.394||0.3507||95.0|-1.145|0.408|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.408|-1.145|0.3507
71650729|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.224|STANDARD_ERROR_OF_MEAN|0.64||0.7276||95.0|-1.498|1.05|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||1.050|-1.498|0.7276
71650730|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.598||0.353||95.0|-1.748|0.631|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3||0.631|-1.748|0.3530
71650731|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.186|STANDARD_ERROR_OF_MEAN|0.529||0.0283||95.0|0.13|2.242|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||2.242|0.130|0.0283
71650732|NCT00442546|142819613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.573||0.6934||95.0|-0.918|1.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6||1.372|-0.918|0.6934
71650733|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.553|STANDARD_ERROR_OF_MEAN|0.77||0.0476||95.0|-3.089|-0.017|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.017|-3.089|0.0476
71650734|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|STANDARD_ERROR_OF_MEAN|0.764||0.0237||95.0|-3.293|-0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.243|-3.293|0.0237
71702682|NCT02260986|142922244|SUPERIORITY||difference in percentages|34.7|||<|0.0001|TWO_SIDED|95.0|27.31|42.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.||42.05|27.31|<0.0001
71702683|NCT02260986|142922245|SUPERIORITY||difference in percentages|23.5|||<|0.0001|TWO_SIDED|95.0|12.72|34.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.19|12.72|<0.0001
71702684|NCT02260986|142922245|SUPERIORITY||difference in percentages|27.5|||<|0.0001|TWO_SIDED|95.0|20.42|34.58||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.||34.58|20.42|<0.0001
71702685|NCT02260986|142922246|SUPERIORITY||difference in percentages|43.6|||<|0.0001|TWO_SIDED|95.0|32.5|54.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||54.65|32.50|<0.0001
71702686|NCT02260986|142922246|SUPERIORITY||difference in percentages|42.5|||<|0.0001|TWO_SIDED|95.0|34.91|50.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.||50.06|34.91|<0.0001
71702687|NCT02260986|142922247|SUPERIORITY||Least square (LS) mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.04|-17.43||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.43|-35.04|<0.0001
71702688|NCT02260986|142922247|SUPERIORITY||LS mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.83|-20.73||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-20.73|-32.83|<0.0001
71702689|NCT02260986|142922248|SUPERIORITY||difference in percentages|38.3|||<|0.0001|TWO_SIDED|95.0|26.96|49.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||49.66|26.96|<0.0001
71702690|NCT02260986|142922248|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|18.76|33.45||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||33.45|18.76|<0.0001
71702691|NCT02260986|142922249|SUPERIORITY||difference in percentages|40.1|||<|0.0001|TWO_SIDED|95.0|28.76|51.35||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||51.35|28.76|<0.0001
71738853|NCT02106403|142990599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.13|||<|0.0001|TWO_SIDED|95.0|6.23|18.04|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||18.04|6.23|<0.0001
71886470|NCT00848354|143293342|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
71886471|NCT00848354|143293344|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0005
71824415|NCT01112735|143152858|SUPERIORITY|||||||0.7564|||||||Wilcoxon (Mann-Whitney)|||Day 90||||0.7564
71702692|NCT02260986|142922249|SUPERIORITY||difference in percentages|27.3|||<|0.0001|TWO_SIDED|95.0|19.81|34.76||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.||34.76|19.81|<0.0001
71702693|NCT02260986|142922250|SUPERIORITY||difference in percentages|37.9|||<|0.0001|TWO_SIDED|95.0|27.34|48.4||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||48.40|27.34|<0.0001
71702694|NCT02260986|142922250|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.65|34.7||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.||34.70|20.65|<0.0001
71702695|NCT02260986|142922251|SUPERIORITY||difference in percentages|20.9|||<|0.0001|TWO_SIDED|95.0|10.59|31.15||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||31.15|10.59|<0.0001
71702696|NCT02260986|142922251|SUPERIORITY||difference in percentages|10.7||||0.0021|TWO_SIDED|95.0|4.15|17.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.||17.31|4.15|0.0021
71702697|NCT02260986|142922252|SUPERIORITY||difference in percentages|9.6||||0.0062|TWO_SIDED|95.0|1.61|17.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||17.63|1.61|0.0062
71702698|NCT02260986|142922252|SUPERIORITY||difference in percentages|5.5||||0.0344|TWO_SIDED|95.0|0.56|10.51||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.||10.51|0.56|0.0344
71702699|NCT02260986|142922253|SUPERIORITY||LS mean difference|-1.81|||<|0.0001|TWO_SIDED|95.0|-2.297|-1.322||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-1.322|-2.297|<0.0001
71702700|NCT02260986|142922254|SUPERIORITY||LS mean difference|-32.1|||<|0.0001|TWO_SIDED|95.0|-46.37|-17.82||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-17.82|-46.37|<0.0001
71702701|NCT02260986|142922255|SUPERIORITY||LS mean difference|-18.38|||<|0.0001|TWO_SIDED|95.0|-22.583|-14.187||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-14.187|-22.583|<0.0001
71702702|NCT02260986|142922256|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.46|-21.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-21.9|-33.46|<0.0001
71824416|NCT03419780|143152871|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71824417|NCT03419780|143152872|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71824418|NCT03419780|143152873|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
71824419|NCT03419780|143152874|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71824420|NCT03419780|143152875|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71824421|NCT03419780|143152876|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71824422|NCT03419780|143152877|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71702703|NCT02260986|142922257|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.31|-3.02||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-3.02|-5.31|<0.0001
71702704|NCT02260986|142922258|SUPERIORITY||LS mean difference|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.85|-5.93||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||-5.93|-8.85|<0.0001
71702705|NCT02260986|142922259|SUPERIORITY||LS mean difference|-1.0||||0.1596|TWO_SIDED|95.0|-2.27|0.37||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.||0.37|-2.27|0.1596
71702706|NCT01771913|142922309|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.310
71702707|NCT01771913|142922310|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.026
71702708|NCT01771913|142922311|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.103
71702709|NCT04307394|142922313|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
71702710|NCT04900272|142922321|OTHER|||||||0.785|||||||ANOVA|||||||0.785
71702711|NCT04900272|142922322|OTHER|||||||0.583|||||||ANOVA|||||||0.583
71824423|NCT02775435|143152889|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.45|0.7||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.70|0.45|<0.0001
71702712|NCT04900272|142922323|OTHER|||||||0.5015|||||||ANOVA|||||||0.5015
71702713|NCT04900272|142922324|OTHER|||||||0.3536|||||||ANOVA|||||||0.3536
71702714|NCT04900272|142922325|OTHER|||||||0.2688|||||||ANOVA|||||||0.2688
71702715|NCT04900272|142922326|OTHER|||||||0.728|||||||ANOVA|||||||0.728
71702716|NCT04900272|142922327|OTHER|||||||0.473|||||||ANOVA|||||||0.473
71702717|NCT04900272|142922328|OTHER|||||||0.4161|||||||ANOVA|||||||0.4161
71702718|NCT04900272|142922329|OTHER|||||||0.3356|||||||ANOVA|||||||0.3356
71702719|NCT04900272|142922330|OTHER|||||||0.9825|||||||ANOVA|||||||0.9825
71702720|NCT00429299|142922356|NON_INFERIORITY_OR_EQUIVALENCE|An exploratory comparison between the combined two single anti-HER2 arms and the dual anti-HER2 arm was performed (Arm 3 versus Arms 1 and 2).|percentage of participants|25.0||||0.019||90.0|13.1|36.9||Exploratory analysis|Chi-squared||The estimated value represents the percentage of particpants in the CT plus trastuzumab treatment group with pathological complete response.|||36.9|13.1|0.019
71702721|NCT00429299|142922356|SUPERIORITY_OR_OTHER||percentage of participants|26.3||||||90.0|14.5|38.1|||||The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response.|||38.1|14.5|
71702722|NCT00429299|142922356|SUPERIORITY_OR_OTHER||percentage of participants|46.7|||||TWO_SIDED|90.0|34.4|58.9|||||The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response.|||58.9|34.4|
71702723|NCT04871113|142922373|OTHER||Emax|-1.848|||||TWO_SIDED|95.0|-2.225|-1.472|||||Emax is defined as maximum response.|||-1.472|-2.225|
71702724|NCT04871113|142922373|OTHER||EC50|68.578|||||TWO_SIDED|95.0|15.866|121.29|||||EC50 is defined as the dose (in mg) that attains the 50% of the maximal effect.|||121.290|15.866|
71702725|NCT04871113|142922373|OTHER||s2e|0.257|||||TWO_SIDED|95.0|0.145|0.368|||||e is defined as random error assumed to be normally distributed with mean zero and constant variance (s2).|||0.368|0.145|
71702726|NCT00315822|142922382|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94||||0.8|TWO_SIDED|95.0|0.52|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.52|0.80
71762757|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.73||||0.3063|TWO_SIDED|90.0|-1.89|0.44|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.44|-1.89|0.3063
71702727|NCT01257542|142922383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.252|TWO_SIDED|95.0|0.59|1.15||p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.|Negative binomial regression|||Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.||1.15|0.59|0.252
71702728|NCT01257542|142922384|SUPERIORITY_OR_OTHER||LS mean difference|-0.26||||0.134|TWO_SIDED|95.0|-0.6|0.08||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.||0.08|-0.60|0.134
71702729|NCT01257542|142922385|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.768|TWO_SIDED|95.0|-0.45|0.33||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.33|-0.45|0.768
71702730|NCT01257542|142922385|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.358|TWO_SIDED|95.0|-0.64|0.23||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.23|-0.64|0.358
71762758|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.4918|TWO_SIDED|90.0|-1.65|0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.68|-1.65|0.4918
71702731|NCT01257542|142922385|SUPERIORITY_OR_OTHER||LS mean difference|-0.32||||0.139|TWO_SIDED|95.0|-0.74|0.1||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.10|-0.74|0.139
71702732|NCT01257542|142922385|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.364|TWO_SIDED|95.0|-0.68|0.25||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.25|-0.68|0.364
71702733|NCT01257542|142922385|SUPERIORITY_OR_OTHER||LS mean difference|-0.46||||0.039|TWO_SIDED|95.0|-0.9|-0.02||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||-0.02|-0.90|0.039
71702734|NCT01257542|142922385|SUPERIORITY_OR_OTHER||LS mean difference|-0.29||||0.206|TWO_SIDED|95.0|-0.75|0.16||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.16|-0.75|0.206
71702735|NCT01257542|142922386|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.304|TWO_SIDED|95.0|-1.43|0.45||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.45|-1.43|0.304
71702736|NCT01257542|142922387|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.954|TWO_SIDED|95.0|-1.03|0.97||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.97|-1.03|0.954
71702737|NCT01257542|142922387|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.426|TWO_SIDED|95.0|-1.54|0.65||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.65|-1.54|0.426
71702738|NCT01257542|142922387|SUPERIORITY_OR_OTHER||LS mean difference|-0.45||||0.396|TWO_SIDED|95.0|-1.49|0.6||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.60|-1.49|0.396
71702739|NCT01257542|142922387|SUPERIORITY_OR_OTHER||LS mean difference|-0.49||||0.402|TWO_SIDED|95.0|-1.63|0.66||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.66|-1.63|0.402
71702740|NCT01257542|142922387|SUPERIORITY_OR_OTHER||LS mean difference|-0.69||||0.204|TWO_SIDED|95.0|-1.75|0.38||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.38|-1.75|0.204
71702741|NCT01257542|142922387|SUPERIORITY_OR_OTHER||LS mean difference|-0.84||||0.179|TWO_SIDED|95.0|-2.06|0.39||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.||0.39|-2.06|0.179
71702742|NCT01257542|142922388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.523|TWO_SIDED|95.0|-0.21|0.39||p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.39|-0.21|0.523
71702743|NCT01257542|142922389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.796|TWO_SIDED|95.0|-0.35|0.24||p-value was calculated from the CMH test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.||0.24|-0.35|0.796
71702744|NCT00693303|142922399|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||.27
71702745|NCT04327271|142922401|NON_INFERIORITY|Non-inferiority margin of -0.25% set as lower bound of 95% CI for the maximum mean difference between the proportion of cumulative AEs between control and 2wT arms to conclude that 2wT is non-inferior. This margin was set considering the average AE rate of 0.5% from routine SSA MC programs at scale, and assuming that 2wT increases AE ascertainment to 2.0%, similar to 1.9% of Zimbabwe RCT and the widely-accepted standard 2% AE rate.|Mean Difference (Final Values)|1.2|||||ONE_SIDED|95.0|-0.09|||||||With 10% loss to follow-up (LTFU), a sample size of 1104 men provides at least 80% power to rule out a decrease in AE ascertainment of more than 0.25% based on the lower bound of the one-sided 95% CI. The one tailed alpha was set 0.05.|||-.09|
71702746|NCT04327271|142922402|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.001|TWO_SIDED|95.0|1.03|1.21|||Fisher Exact|||The mean number of in-person clinic visit, excluding non-study visits, were compared between the two arms using a t-test. The proportion of potential AEs was calculated as number of potential AE responses divided by the total number of daily responses (no AE and potential AE). A superiority test was performed on the safety outcomes using a two-sided 95% confidence interval and p-value using Fisher's exact test.||1.21|1.03|0.001
71702747|NCT01479530|142922417|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0228|TWO_SIDED|95.0|-0.92|-0.07|||ANCOVA|||||-0.07|-0.92|0.0228
71702748|NCT01479530|142922418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||ANCOVA|||||-0.22|-0.61|<0.0001
71824424|NCT02775435|143152890|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0008|TWO_SIDED|95.0|0.49|0.85||Treatment comparison stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score \[TPS\] ≥1% vs. \<1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) \& geographic region (East Asia vs. non-East Asia)|Regression, Cox|||||0.85|0.49|0.0008
71824425|NCT00097253|143152895|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Regression, Linear|||Cortisol. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.83
71702749|NCT01479530|142922419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.37||0.0075|TWO_SIDED|95.0|-1.75|-0.27|||ANCOVA|||||-0.27|-1.75|0.0075
71702750|NCT01479530|142922420|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.74||0.0317|TWO_SIDED|95.0|-3.05|-0.14|||ANCOVA|||||-0.14|-3.05|0.0317
71702751|NCT00303628|142922421|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876|TWO_SIDED|||||Stratified log rank test. The above P value was for one-sided test|Log Rank|||||||0.876
71702752|NCT00303628|142922422|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED|||||two-sided stratified log rank test p value|Log Rank|||||||0.299
71702753|NCT03487445|142922452|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 8 mg is described in statistical analysis 2: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 8 mg dose.|||||<|0.001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.001
71702754|NCT03487445|142922452|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 8 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.142||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.142
71702755|NCT03487445|142922452|SUPERIORITY|The statistical analysis comprised a 2-step testing strategy. The first test, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 50% (null hypothesis: proportion of responders \<50%) and is reported below. The second step for the Selatogrel 16 mg is described in statistical analysis 4: In this second analysis the subsequent null hypothesis of treatment effect less or equal to 85% was tested for the 16 mg dose.|||||<|0.0001||||||P-value for hypotheses (H0: p \<= 50% vs. H1: p \> 50%)|one-sided z-test|A p-value significance level was set to 0.025.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||<0.0001
71702756|NCT03487445|142922452|SUPERIORITY|This statistical analysis reports the second of the 2-step testing strategy. This second test for the 16 mg Selatogrel dose, carried out at an alpha level of 0.025, determined whether the proportion of responders (patients with a PRU value \<100) was ≥ 85% (null hypothesis: proportion of responders \<85%).||||||0.009||||||P-value for hypotheses (H0: p \<= 85% vs. H1: p \> 85%)|one-sided z-test|A p-value significance level was set to 0.025, an overall level of 0.05 and adjusted for multiplicity using the Bonferroni approach.||The main analysis (mFAS, treatment dose as received) of treatment effect on the primary endpoint was conducted independently for each dose.||||0.009
71702757|NCT03487445|142922453|SUPERIORITY|||||||0.228||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.2280
71702758|NCT03487445|142922453|SUPERIORITY|||||||0.0201||||||P-value for hypotheses (H0: p \<= 85% versus H1: p \> 85%)|One-sided Z-test|||As per the main analysis (mFAS) the supporting analysis on the per-protocol set this analysis of treatment effect was conducted independently for each dose, i.e., 8 and 16 mg.||||0.0201
71702759|NCT03301714|142922459|EQUIVALENCE|equivalence analysis|Mean Difference (Final Values)|7.62||||0|TWO_SIDED|95.0||||baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold \<0.01)|Regression, Linear||Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.|||||.000
71702760|NCT02906618|142922537|OTHER|A mixed-effect analysis of variance model was applied to the log-transformed dose-adjusted AUC(0-∞) of LY3039478 after oral dosing and IV administration of 13C 15N 2H-LY3039478. The model contained a fixed effect for formulation (oral or IV) and a random effect for participant.|Ratio of geometric LS means|0.572|||||TWO_SIDED|90.0|0.532|0.615||||||||0.615|0.532|
71702761|NCT00143507|142922544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.945|TWO_SIDED|95.0|0.91|1.1|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.10|0.91|0.945
71702762|NCT00143507|142922545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.316|TWO_SIDED|95.0|0.94|1.22|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.22|0.94|0.316
71702763|NCT00143507|142922546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.159|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.72|0.159
71739291|NCT00999518|142991307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.15|0.83||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.83|-1.15|
71824426|NCT00097253|143152895|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Mixed Models Analysis|||Epinephrine. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.||||0.16
71702764|NCT00143507|142922547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.85|TWO_SIDED|95.0|0.86|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.86|0.850
71702765|NCT00143507|142922548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.547|TWO_SIDED|95.0|0.92|1.16|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.16|0.92|0.547
71702766|NCT00143507|142922549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.331|TWO_SIDED|95.0|0.71|1.12|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.12|0.71|0.331
71702767|NCT00143507|142922550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.078|TWO_SIDED|95.0|0.67|1.02|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.02|0.67|0.078
71702768|NCT00143507|142922551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.583|TWO_SIDED|95.0|0.83|1.4|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.40|0.83|0.583
71702769|NCT00143507|142922552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.501|TWO_SIDED|95.0|0.81|1.11|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.11|0.81|0.501
71702770|NCT00143507|142922553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.141|TWO_SIDED|95.0|0.78|1.04|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.04|0.78|0.141
71702771|NCT00143507|142922554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.411|TWO_SIDED|95.0|0.86|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.06|0.86|0.411
71702772|NCT00143507|142922555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.484|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.15|0.94|0.484
71702773|NCT00143507|142922556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.835|TWO_SIDED|95.0|0.9|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.|||1.13|0.90|0.835
71702774|NCT01115231|142922583|OTHER|multivariable logistic regression model|Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.93|4.42||||||||4.42|0.93|
71702775|NCT03928327|142922591|OTHER||Geometric Least Squares (LS) Mean Ratio|2.86|||||TWO_SIDED|90.0|2.48|3.3|||||Linear mixed-effects model was used for analysis, using fixed-effect(treatment), random-effect(participants). Geometric mean ratios(GMR), 90% confidence interval(CI) calculated using exponentiation of treatment least squares means(LSMs) difference.|||3.30|2.48|
71702776|NCT03928327|142922592|OTHER||Geometric LS Mean Ratio|0.08|||||TWO_SIDED|90.0|0.07|0.11|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.11|0.07|
71702777|NCT03928327|142922593|OTHER||Geometric LS Mean Ratio|6.27|||||TWO_SIDED|90.0|5.2|7.56|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||7.56|5.20|
71702778|NCT03928327|142922594|OTHER||Geometric LS Mean Ratio|0.05|||||TWO_SIDED|90.0|0.04|0.07|||||Linear mixed-effects model was used for analysis, using fixed-effect (treatment) and random-effect (participants). GMR and 90% CI was calculated using exponentiation of treatment LSMs difference.|||0.07|0.04|
71702779|NCT00407511|142922598|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If \< = 7 and \> = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.||||< 0.0001
71702780|NCT00407511|142922599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4||-2.8|-3.6|< 0.0001
71702781|NCT00407511|142922599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.3|-3.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8||-3.5|-4.3|< 0.0001
71702782|NCT00407511|142922599|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12||-3.7|-4.5|< 0.0001
71702783|NCT00407511|142922600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.7|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).||-3.7|-4.7|< 0.0001
71702784|NCT00407511|142922600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-5.1|-4.1|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= 78 days).||-4.1|-5.1|< 0.0001
71702785|NCT00407511|142922600|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
71824427|NCT00097253|143152895|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||Mixed Models Analysis|||Norepinephrine. Model controlled for Time 1 baseline. Comparing timepoints 4 and 5 for pre versus post stressor, e.g. lemon versus water control; Citrus(5-4)-Water(5-4).||||0.017
71886472|NCT00848354|143293344|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
71650735|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.402||0.4925||95.0|-0.516|1.069|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||1.069|-0.516|0.4925
71650736|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.414||0.8299||95.0|-0.727|0.905|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.905|-0.727|0.8299
71650737|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.37||0.9185||95.0|-0.766|0.691|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.691|-0.766|0.9185
71650738|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.339|STANDARD_ERROR_OF_MEAN|0.371||0.3619||95.0|-1.07|0.392|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.392|-1.070|0.3619
71650739|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.453||0.4309||95.0|-0.538|1.254|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.254|-0.538|0.4309
71650740|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.459||0.9778||95.0|-0.895|0.921|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.921|-0.895|0.9778
71650741|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.777||0.8503||95.0|-1.411|1.706|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.706|-1.411|0.8503
71650742|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.845|STANDARD_ERROR_OF_MEAN|0.757||0.0183||95.0|-3.364|-0.326|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.326|-3.364|0.0183
71650743|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.141|STANDARD_ERROR_OF_MEAN|0.956||0.286||95.0|-3.598|1.316|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||1.316|-3.598|0.2860
71650744|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|1.856||0.204||95.0|-7.479|2.06|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.060|-7.479|0.2040
71650745|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.295||0.6332||95.0|-0.722|0.44|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.440|-0.722|0.6332
71702786|NCT00407511|142922601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.2|-3.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).||-3.4|-4.2|< 0.0001
71824428|NCT00097253|143152896|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Models Analysis|||IL-6. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.10
71650746|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.303||0.5183||95.0|-0.402|0.794|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.794|-0.402|0.5183
71650747|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.306||0.6341||95.0|-0.75|0.458|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.458|-0.750|0.6341
71650748|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|0.32||0.4607||95.0|-0.868|0.395|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.395|-0.868|0.4607
71650749|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.327||0.7499||95.0|-0.541|0.75|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.750|-0.541|0.7499
71650750|NCT00442546|142819614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.333||0.8231||95.0|-0.584|0.733|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.733|-0.584|0.8231
71650751|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.709||0.1486||95.0|-2.452|0.379|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.379|-2.452|0.1486
71650752|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.903|STANDARD_ERROR_OF_MEAN|0.706||0.0089||95.0|-3.311|-0.494|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||-0.494|-3.311|0.0089
71650753|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.344||0.8995||95.0|-0.635|0.722|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.722|-0.635|0.8995
71650754|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.303|STANDARD_ERROR_OF_MEAN|0.354||0.3918||95.0|-1.0|0.394|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.394|-1.000|0.3918
71650755|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.33||0.9942||95.0|-0.648|0.652|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.652|-0.648|0.9942
71650756|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.332||0.5352||95.0|-0.859|0.448|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.448|-0.859|0.5352
71702787|NCT00407511|142922601|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (\>= Day 78)||-3.7|-4.5|< 0.0001
71702788|NCT00407511|142922601|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.||||< 0.0001
71702789|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-22.3|-14.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.||-14.0|-22.3|< 0.0001
71702790|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.2|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-32.4|-24.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.||-24.0|-32.4|< 0.0001
71702791|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.3|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001||95.0|-38.5|-30.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.||-30.0|-38.5|< 0.0001
71702792|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.9|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-45.2|-36.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.||-36.7|-45.2|< 0.0001
71702793|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-50.2|-41.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.||-41.4|-50.2|< 0.0001
71702794|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.4|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001||95.0|-52.8|-44.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell \>= Day 78.||-44.0|-52.8|< 0.0001
71702795|NCT00407511|142922604|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
71702796|NCT00407511|142922605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-43.4|-33.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.||-33.9|-43.4|< 0.0001
71702797|NCT00407511|142922605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-45.5|-35.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell \>=Day 78.||-35.9|-45.5|< 0.0001
71702798|NCT00407511|142922605|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.||||< 0.0001
71702799|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.4|-0.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-0.7|-1.4|< 0.0001
71824429|NCT00097253|143152896|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Mixed Models Analysis|||IL-10. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.||||0.50
71702800|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.2|-1.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-1.5|-2.2|< 0.0001
71702801|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-2.9|-2.2|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.2|-2.9|< 0.0001
71702802|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.2|-2.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.5|-3.2|< 0.0001
71702803|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.3|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.3|< 0.0001
71702804|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.4|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.6|-3.4|< 0.0001
71702805|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.5|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.5|< 0.0001
71702806|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.8|-3.6|< 0.0001
71702807|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-2.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-2.9|-3.7|< 0.0001
71702808|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
71702809|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.8|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.8|< 0.0001
71702810|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.||-3.0|-3.7|< 0.0001
71702811|NCT00407511|142922606|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.||||< 0.0001
71702812|NCT03439514|142922613|SUPERIORITY||Median Difference (Net)|4.936||||0.818|TWO_SIDED|95.0|-24.246|34.118||Two-sided p-value|Van Elteren test||The Week 24 change from baseline in 6MWT between PF 07265803 and placebo was estimated using the stratified HL median difference, considering only participants who survived 24 weeks.|||34.118|-24.246|0.818
71702813|NCT03439514|142922619|OTHER||Hazard Ratio (HR)|0.43||||0.2257|TWO_SIDED|95.0|0.13|1.39|||Log Rank|||||1.39|0.13|0.2257
71702814|NCT03439514|142922620|OTHER||Hazard Ratio (HR)|1.19||||0.837|TWO_SIDED|95.0|0.3|4.63|||Log Rank|||||4.63|0.30|0.8370
71702815|NCT02175758|142922626|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|109.96|152.48||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||152.48|109.96|
71702816|NCT02175758|142922626|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|109.8|||||TWO_SIDED|90.0|93.25|129.29||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||129.29|93.25|
71702817|NCT02175758|142922626|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|149.67|||||TWO_SIDED|90.0|127.12|176.21||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||176.21|127.12|
71702818|NCT02175758|142922628|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 12 to \< 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to \< 18 Years Old group, then the SVR12 rate for participants aged 3 to \< 12 years would be compared with 80% at the 0.05 significance level.||||<0.001
71702819|NCT02175758|142922628|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 3 to \< 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
71702820|NCT03927157|142922675|SUPERIORITY||Rate Ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.17|0.39|||Negative Binomial Regression|||||0.39|0.17|<0.001
71762759|NCT02785770|143027147|SUPERIORITY_OR_OTHER||LS mean difference|-0.61||||0.3862|TWO_SIDED|90.0|-1.78|0.55|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.||0.55|-1.78|0.3862
71762760|NCT04518995|143027156|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.23|<0.0001
71762761|NCT04518995|143027156|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.46|0.32|<0.0001
71762762|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.17|0.32||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.32|0.17|<0.0001
71762763|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.26|0.43||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.26|<0.0001
71650757|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.382||0.8055||95.0|-0.662|0.85|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.850|-0.662|0.8055
71650758|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.446|STANDARD_ERROR_OF_MEAN|0.391||0.256||95.0|-1.22|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.327|-1.220|0.2560
71650759|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.641||0.8744||95.0|-1.184|1.387|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.387|-1.184|0.8744
71650760|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.614|STANDARD_ERROR_OF_MEAN|0.616||0.0115||95.0|-2.851|-0.378|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.378|-2.851|0.0115
71650761|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.155||0.9497||95.0|-3.047|2.893|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||2.893|-3.047|0.9497
71650762|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.347|STANDARD_ERROR_OF_MEAN|1.992||0.5288||95.0|-6.467|3.773|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||3.773|-6.467|0.5288
71650763|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.262||0.2595||95.0|-0.813|0.22|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.220|-0.813|0.2595
71650764|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.27||0.9605||95.0|-0.546|0.519|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.519|-0.546|0.9605
71650765|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.207|STANDARD_ERROR_OF_MEAN|0.251||0.4107||95.0|-0.702|0.288|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.288|-0.702|0.4107
71650766|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.263||0.2271||95.0|-0.836|0.2|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.200|-0.836|0.2271
71650767|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.263||0.9552||95.0|-0.535|0.506|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.506|-0.535|0.9552
71650768|NCT00442546|142819615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.268||0.9899||95.0|-0.533|0.526|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.526|-0.533|0.9899
71650769|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.578|STANDARD_ERROR_OF_MEAN|0.471||0.2211||95.0|-0.35|1.506|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||1.506|-0.350|0.2211
71650770|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.477||0.0916||95.0|-1.75|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||0.132|-1.750|0.0916
71650771|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.42||0.9312||95.0|-0.863|0.791|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.791|-0.863|0.9312
71650772|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.591|STANDARD_ERROR_OF_MEAN|0.425||0.1658||95.0|-1.428|0.247|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours||0.247|-1.428|0.1658
71650773|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.483||0.9921||95.0|-0.958|0.948|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.948|-0.958|0.9921
71650774|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.715|STANDARD_ERROR_OF_MEAN|0.479||0.1367||95.0|-1.66|0.229|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours||0.229|-1.660|0.1367
71650775|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.364||0.3561||95.0|-1.053|0.38|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.380|-1.053|0.3561
71650776|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.366||0.426||95.0|-1.012|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||0.429|-1.012|0.4260
71650777|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.41||0.7975||95.0|-0.703|0.914|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.914|-0.703|0.7975
71650778|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.412||0.6947||95.0|-0.65|0.974|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours||0.974|-0.650|0.6947
71650779|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.465||0.6954||95.0|-1.101|0.736|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.736|-1.101|0.6954
71650780|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.081|STANDARD_ERROR_OF_MEAN|0.481||0.8665||95.0|-1.032|0.87|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours||0.870|-1.032|0.8665
71650781|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.386||0.4216||95.0|-0.45|1.072|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.072|-0.450|0.4216
71650782|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.391||0.4673||95.0|-0.487|1.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||1.056|-0.487|0.4673
71650783|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.44||0.5624||95.0|-0.614|1.125|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||1.125|-0.614|0.5624
71650784|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.448||0.3705||95.0|-1.286|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours||0.482|-1.286|0.3705
71650785|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.358|STANDARD_ERROR_OF_MEAN|0.476||0.4539||95.0|-1.302|0.586|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||0.586|-1.302|0.4539
71650786|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.086|STANDARD_ERROR_OF_MEAN|0.515||0.0373||95.0|-2.107|-0.065|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours||-0.065|-2.107|0.0373
71650787|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.476||0.76||95.0|-0.796|1.087|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||1.087|-0.796|0.7600
71650788|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.555|STANDARD_ERROR_OF_MEAN|0.481||0.2506||95.0|-1.507|0.397|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.397|-1.507|0.2506
71650789|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.895||0.2567||95.0|-0.77|2.823|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||2.823|-0.770|0.2567
71650790|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.882|STANDARD_DEVIATION|0.76||0.0167||95.0|-3.408|-0.356|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours||-0.356|-3.408|0.0167
71650791|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.89||0.6953||95.0|-1.456|2.159|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||2.159|-1.456|0.6953
71650792|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.147|STANDARD_ERROR_OF_MEAN|0.894||0.208||95.0|-2.962|0.668|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours||0.668|-2.962|0.2080
71650793|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.867|STANDARD_ERROR_OF_MEAN|0.975||0.3805||95.0|-1.116|2.849|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.849|-1.116|0.3805
71650794|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.905||0.89||95.0|-1.965|1.713|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||1.713|-1.965|0.8900
71650795|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.672|STANDARD_ERROR_OF_MEAN|1.08||0.1821||95.0|-1.103|4.448|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||4.448|-1.103|0.1821
71650796|NCT00442546|142819616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.851|STANDARD_ERROR_OF_MEAN|1.768||0.6505||95.0|-3.693|5.395|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours||5.395|-3.693|0.6505
71650797|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.029|STANDARD_ERROR_OF_MEAN|0.495||0.0388||95.0|-2.004|-0.053|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.053|-2.004|0.0388
71650798|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.501||0.0004||95.0|-2.798|-0.822|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||-0.822|-2.798|0.0004
71650799|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.405||0.6274||95.0|-0.995|0.601|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.601|-0.995|0.6274
71650800|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.619|STANDARD_ERROR_OF_MEAN|0.413||0.135||95.0|-1.432|0.194|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||0.194|-1.432|0.1350
71650801|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.719|STANDARD_ERROR_OF_MEAN|0.448||0.1106||95.0|-1.605|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||0.166|-1.605|0.1106
71650802|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.036|STANDARD_ERROR_OF_MEAN|0.457||0.0248||95.0|-1.939|-0.133|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||-0.133|-1.939|0.0248
71650803|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.725||0.2335||95.0|-0.582|2.33|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||2.330|-0.582|0.2335
71650804|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.568|STANDARD_ERROR_OF_MEAN|0.682||0.0258||95.0|-2.939|-0.198|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||-0.198|-2.939|0.0258
71650805|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.866|STANDARD_ERROR_OF_MEAN|1.973||0.3878||95.0|-3.207|6.939|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||6.939|-3.207|0.3878
71702821|NCT03927157|142922676|SUPERIORITY||Least Squares Mean Difference|0.24|||<|0.001|TWO_SIDED|95.0|0.16|0.32|||Mixed Models Analysis|||||0.32|0.16|<0.001
71824430|NCT00097253|143152897|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Mixed Models Analysis|||Repeated-measures mixed effects models were used. Model was fit to the log-transformed data. Analysis applied to odor category, e.g. lavender / lemon / water.||||0.60
71824431|NCT00097253|143152898|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Linear|||The maximum DTH wheal of days 1-3 (24, 48, or 72 h) was used as the dependent variable for each subject at each visit. Visits for subjects with a maximum DTH wheal of 5mm or less were excluded. A repeated measures linear model was used to evaluate odor and placebo effects.||||0.014
71650806|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.909|STANDARD_ERROR_OF_MEAN|3.754||0.1762||95.0|-3.74|15.559|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.559|-3.740|0.1762
71650807|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.515|STANDARD_ERROR_OF_MEAN|0.379||0.1754||95.0|-1.261|0.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.231|-1.261|0.1754
71650808|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.569|STANDARD_ERROR_OF_MEAN|0.386||0.1413||95.0|-1.329|0.191|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.191|-1.329|0.1413
71650809|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.419|STANDARD_ERROR_OF_MEAN|0.306||0.1731||95.0|-1.023|0.185|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.185|-1.023|0.1731
71650810|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|0.314||0.6829||95.0|-0.747|0.49|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||0.490|-0.747|0.6829
71650811|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.3||0.2436||95.0|-0.943|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.241|-0.943|0.2436
71650812|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.313||0.119||95.0|-1.108|0.127|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.127|-1.108|0.1190
71650813|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.264|STANDARD_ERROR_OF_MEAN|0.321||0.4117||95.0|-0.897|0.369|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.369|-0.897|0.4117
71650814|NCT00442546|142819617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.323||0.6294||95.0|-0.794|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||0.482|-0.794|0.6294
71650815|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.859|STANDARD_ERROR_OF_MEAN|3.315||0.7958||95.0|-7.391|5.673|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||5.673|-7.391|0.7958
71650816|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|3.322||0.9733||95.0|-6.436|6.659|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1||6.659|-6.436|0.9733
71650817|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.889|STANDARD_ERROR_OF_MEAN|3.946||0.822||95.0|-6.898|8.675|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||8.675|-6.898|0.8220
71650818|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.813|STANDARD_ERROR_OF_MEAN|3.917||0.4736||95.0|-10.542|4.917|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour||4.917|-10.542|0.4736
71650819|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.662|STANDARD_ERROR_OF_MEAN|4.045||0.5113||95.0|-10.639|5.316|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||5.316|-10.639|0.5113
71650820|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.365|STANDARD_ERROR_OF_MEAN|3.95||0.9266||95.0|-7.425|8.154|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours||8.154|-7.425|0.9266
71650821|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|4.347||0.9699||95.0|-8.423|8.751|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.751|-8.423|0.9699
71650822|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|4.232||0.9482||95.0|-8.085|8.635|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours||8.635|-8.085|0.9482
71650823|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.915|STANDARD_ERROR_OF_MEAN|7.391||0.7969||95.0|-16.842|13.012|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||13.012|-16.842|0.7969
71650824|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.023|STANDARD_ERROR_OF_MEAN|7.68||0.1991||95.0|-25.533|5.487|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours||5.487|-25.533|0.1991
71650825|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.335|STANDARD_ERROR_OF_MEAN|22.737||0.0321||95.0|13.976|158.693|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||158.693|13.976|0.0321
71650826|NCT00442546|142819618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.964|STANDARD_ERROR_OF_MEAN|12.295||0.0353||95.0|5.837|84.091|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours||84.091|5.837|0.0353
71650827|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.812|STANDARD_ERROR_OF_MEAN|12.055||0.5736||95.0|-30.792|17.169|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||17.169|-30.792|0.5736
71650828|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.991|STANDARD_ERROR_OF_MEAN|11.786||0.8003||95.0|-26.438|20.455|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||20.455|-26.438|0.8003
71650829|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.815|STANDARD_ERROR_OF_MEAN|10.371||0.5125||95.0|-27.369|13.74|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||13.740|-27.369|0.5125
71650830|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.294|STANDARD_ERROR_OF_MEAN|10.227||0.4773||95.0|-27.563|12.976|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||12.976|-27.563|0.4773
71702822|NCT03927157|142922677|SUPERIORITY||Least Squares Means Difference|0.35||||0.001|TWO_SIDED|95.0|0.14|0.55|||Mixed Models Analysis|||||0.55|0.14|0.001
71702823|NCT03927157|142922678|SUPERIORITY||Least Squares Means Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<0.001
71702824|NCT03927157|142922679|SUPERIORITY||Least Squares Means Difference|-0.16||||0.001|TWO_SIDED|95.0|-0.27|-0.06|||Mixed Models Analysis|||||-0.06|-0.27|0.001
71702825|NCT00081458|142922711|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANCOVA|||||||0.007
71702826|NCT00081458|142922712|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANCOVA|||An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.||||0.005
71702827|NCT03384966|142922737|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.0001|TWO_SIDED|97.5|22.4|154.8||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values."||154.8|22.4|< 0.0001
71702828|NCT03384966|142922737|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|23.1|162.3||A p-value significance level was set to 0.025, based on an overall Type-I error rate of 0.05 adjusted for multiple comparisons using a Bonferroni approach (two comparisons).|Chi-squared|||"The study aimed at assessing the efficacy of each selatogrel dose versus placebo. The proportion of responders for each of the two doses of selatogrel was compared to placebo.~No imputation was considered for handling missing values in the main analysis."||162.3|23.1|< 0.0001
71702829|NCT03384966|142922741|OTHER|Logistic regression (Type III analysis)||||||0.1915|||||||Chi-squared|||||||0.1915
71702830|NCT03384966|142922743|OTHER||LS Mean difference with placebo|-27.49|||<|0.0001|TWO_SIDED|95.0|-35.4|-19.6|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach.||Longitudinal analysis of the treatment effect, from start of treatment to 8 hours after injection.||-19.6|-35.4|<.0001
71702831|NCT03384966|142922743|OTHER||LS Mean difference with placebo|-31.06|||<|0.0001|TWO_SIDED|95.0|-39.0|-23.1|||Mixed Models Analysis|P-value significance level is set to 0.025, i.e. type I error (0.05) adjusted for multiplicity (2 comparisons) using a Bonferroni approach||Longitudinal analysis of the treatment effect, from start of treatment up to 8 hours after injection.||-23.1|-39.0|<.0001
71702832|NCT02202616|142922746|OTHER||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|0.14|0.21|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.21|0.14|
71702833|NCT02202616|142922747|OTHER||Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.278|||TWO_SIDED|95.0|0.11|0.17|||Descriptive Statistics with 95% CI|The mean change from baseline along with the 95% confidence interval used to assess the precision of the estimate||||0.17|0.11|
71702834|NCT02202616|142922748|OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.47|||TWO_SIDED|95.0|1.74|2.3|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit.||Week 4||2.30|1.74|
71702835|NCT02202616|142922748|OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.92|||TWO_SIDED|95.0|2.21|2.85|||Standard Descriptive Statistics|The estimated mean change from baseline and corresponding 95% confidence intervals will be displayed for each visit||Week 16||2.85|2.21|
71702836|NCT02202616|142922749|OTHER||Mean Difference (Final Values)|-5.0|STANDARD_DEVIATION|6.25|||TWO_SIDED|95.0|-5.7|-4.3|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 4||-4.3|-5.7|
71702837|NCT02202616|142922749|OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|7.03|||TWO_SIDED|95.0|-7.3|-5.7|||standard descriptive statistics|The estimated mean change from baseline to Week 4 along with the 95% confidence interval||Week 16||-5.7|-7.3|
71702838|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.82|4.38|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual. Sample sizing calculated based on results from previous methodology studies performed using the same cold pain test; primary criteria was ability to detect a significant gabapentin effect over placebo.||4.38|-3.82|
71762764|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.24|0.38||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.38|0.24|<0.0001
71702839|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.53|4.68|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.68|-3.53|
71702840|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|90.0|-3.99|4.22|||Mixed Models Analysis|||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.99|
71702841|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-1.15|5.44|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||5.44|-1.15|
71702842|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-14.48|-7.89|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.89|-14.48|
71702843|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|90.0|2.2|8.78|||Mixed Models Analysis|||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||8.78|2.20|
71702844|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-5.53|4.08|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.08|-5.53|
71702845|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|90.0|-18.74|-9.13|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-9.13|-18.74|
71702846|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.88|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-2.01|7.78|||Mixed Models Analysis|||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.78|-2.01|
71702847|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.66|||TWO_SIDED|90.0|-5.32|6.96|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||6.96|-5.32|
71702848|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.12|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-19.14|-7.09|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-7.09|-19.14|
71702849|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|90.0|-4.45|7.6|||Mixed Models Analysis|||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||7.60|-4.45|
71702850|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-7.39|2.32||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||2.32|-7.39|
71702851|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-14.44|-4.73|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-4.73|-14.44|
71702852|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|90.0|-4.85|4.85|||Mixed Models Analysis|||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.85|-4.85|
71702853|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.23|4.22|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||4.22|-3.23|
71702854|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.47|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-11.19|-3.75|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||-3.75|-11.19|
71702855|NCT01119222|142922768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|90.0|-3.99|3.45|||Mixed Models Analysis|||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.||3.45|-3.99|
71824432|NCT01219855|143152899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Z-test cmpared 2 independ. proportions|||||||<0.0001
71702856|NCT01119222|142922769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-4.24|3.04|||Mixed Models Analysis|||||3.04|-4.24|
71702857|NCT01119222|142922769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.43|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-13.07|-5.79|||Mixed Models Analysis|||||-5.79|-13.07|
71702858|NCT01119222|142922769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|90.0|-2.8|4.48|||Mixed Models Analysis|||||4.48|-2.80|
71702859|NCT00221104|142922790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8234|TWO_SIDED|95.0|0.73|1.29|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.29|0.73|0.8234
71702860|NCT00221104|142922791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.0047|TWO_SIDED|95.0|0.15|0.74|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||0.74|0.15|0.0047
71702861|NCT00221104|142922792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.3075|TWO_SIDED|95.0|0.81|1.91|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||1.91|0.81|0.3075
71702862|NCT00221104|142922793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.1986|TWO_SIDED|95.0|0.61|9.14|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||9.14|0.61|0.1986
71824433|NCT01219855|143152900|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
71824434|NCT01219855|143152901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
71650831|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.915|STANDARD_ERROR_OF_MEAN|11.101||0.2142||95.0|-36.055|8.226|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.226|-36.055|0.2142
71824435|NCT01219855|143152901|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Mixed effect model|||||||<0.01
71650832|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.769|STANDARD_ERROR_OF_MEAN|11.245||0.2989||95.0|-34.197|10.659|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||10.659|-34.197|0.2989
71650833|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.51|STANDARD_ERROR_OF_MEAN|45.612||0.3829||95.0|-53.429|134.449|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||134.449|-53.429|0.3829
71650834|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.25|STANDARD_ERROR_OF_MEAN|45.322||0.5531||95.0|-120.59|66.092|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||66.092|-120.59|0.5531
71650835|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.513|STANDARD_ERROR_OF_MEAN|8.491||0.2738||95.0|-89.376|126.402|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||126.402|-89.376|0.2738
71650836|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.644|STANDARD_ERROR_OF_MEAN|2.519||0.7987||95.0|-4.343|5.63|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.630|-4.343|0.7987
71650837|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|2.441||0.8875||95.0|-5.177|4.485|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||4.485|-5.177|0.8875
71650838|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.537|STANDARD_ERROR_OF_MEAN|1.949||0.4319||95.0|-2.324|5.398|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.398|-2.324|0.4319
71650839|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.935||0.407||95.0|-2.223|5.443|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||5.443|-2.223|0.4070
71650840|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.641||0.4968||95.0|-4.371|2.133|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.133|-4.371|0.4968
71702863|NCT00221104|142922794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9953|TWO_SIDED|95.0|0.45|2.22|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)||2.22|0.45|0.9953
71702864|NCT02989389|142922801|SUPERIORITY||Mean Difference (Final Values)|-11.57||||0.215|TWO_SIDED|90.0|-29.52|10.96|||Mixed Models Analysis|||Aβ 1-40||10.96|-29.52|0.215
71702865|NCT02989389|142922801|SUPERIORITY||Mean Difference (Final Values)|-60.53|||<|0.001|TWO_SIDED|90.0|-69.79|-48.43|||Mixed Models Analysis|||Aβ 1-40||-48.43|-69.79|<0.001
71702866|NCT02989389|142922801|SUPERIORITY||Mean Difference (Final Values)|-87.07|||<|0.001|TWO_SIDED|90.0|-90.21|-82.92|||Mixed Models Analysis|||Aβ 1-40||-82.92|-90.21|<0.001
71650841|NCT00442546|142819619|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.327|STANDARD_ERROR_OF_MEAN|1.665||0.427||95.0|-1.972|4.626|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||4.626|-1.972|0.4270
71702867|NCT02989389|142922801|SUPERIORITY||Mean Difference (Final Values)|-19.6||||0.015|TWO_SIDED|90.0|-33.69|-2.51|||Mixed Models Analysis|||Aβ 1-42||-2.51|-33.69|0.015
71702868|NCT02989389|142922801|SUPERIORITY||Mean Difference (Final Values)|-65.41|||<|0.001|TWO_SIDED|90.0|-72.23|-56.92|||Mixed Models Analysis|||Aβ 1-42||-56.92|-72.23|<0.001
71702869|NCT02989389|142922801|SUPERIORITY||Mean Difference (Final Values)|-84.56|||<|0.001|TWO_SIDED|90.0|-88.97|-78.38|||Mixed Models Analysis|||Aβ 1-42||-78.38|-88.97|<0.001
71824436|NCT01219855|143152902|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed effect model|||||||<0.0001
71650842|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.862|STANDARD_ERROR_OF_MEAN|2.999||0.7742||95.0|-6.775|5.052|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||5.052|-6.775|0.7742
71650843|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.006|STANDARD_ERROR_OF_MEAN|3.025||0.0996||95.0|-0.96|10.971|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||10.971|-0.960|0.0996
71650844|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.803|STANDARD_ERROR_OF_MEAN|2.79||0.7738||95.0|-4.698|6.304|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||6.304|-4.698|0.7738
71650845|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.192|STANDARD_ERROR_OF_MEAN|2.778||0.1328||95.0|-1.284|9.669|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.669|-1.284|0.1328
71650846|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|3.012||0.7585||95.0|-5.027|6.882|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||6.882|-5.027|0.7585
71702870|NCT04470427|142922810|OTHER||VE|93.2|||<|0.0001|TWO_SIDED|95.0|91.0|94.8|||Vaccine Efficacy (VE)|VE (percent) is demonstrated if the lower limit of the 2-sided confidence interval for the VE is above 30%.|VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|"Vaccine efficacy was defined as the percent reduction in the hazard of the primary endpoint (mRNA-1273 vs. placebo).~Null hypothesis of Vaccine Efficacy ≤30%, 95% CI."||94.8|91.0|<.0001
71702871|NCT04470427|142922816|OTHER||VE|98.2|||||TWO_SIDED|95.0|92.8|99.6|||VE||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||99.6|92.8|
71824437|NCT01219855|143152903|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Z-test compared 2 independ. proportions|||||||<0.05
71824438|NCT01219855|143152904|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Z-test compared 2 independ. proportions|||The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.||||<0.001
71702872|NCT04470427|142922817|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.2|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model|||84.2|79.5|
71702873|NCT04470427|142922818|OTHER|VE|VE|93.4|||||TWO_SIDED|95.0|91.4|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.4|
71702874|NCT04470427|142922820|OTHER||VE|93.3|||||TWO_SIDED|95.0|91.1|94.9|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||94.9|91.1|
71702875|NCT04470427|142922821|OTHER||VE|82.0|||||TWO_SIDED|95.0|79.5|84.3|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||84.3|79.5|
71702876|NCT04470427|142922822|OTHER||VE|63.0|||||TWO_SIDED|95.0|56.6|68.5|||||VE (percent) was estimated with 1 - Hazard Ratio (mRNA-1273 vs. placebo) from stratified Cox proportional hazard model.|||68.5|56.6|
71702877|NCT04470427|142922828|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on Ratio of GMC is demonstrated if lower bound of 95% CI of Ratio of GMC ≥ 0.67.|Ratio of GMC|6.996|||||TWO_SIDED|95.0|6.509|7.52||||||Ratio of GMC 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57).||7.520|6.509|
71702878|NCT04470427|142922829|NON_INFERIORITY|Non-inferiority of a booster as compared with mRNA-1273 after second dose based on SRR difference is demonstrated if lower bound of 95% CI of SRR difference \> -10%.|Difference in Seroresponse|0.9|||||TWO_SIDED|95.0|0.1|1.8|||||95% CI were calculated using adjusted Wald method for the paired binary data.|Seroresponse 28 days following the booster dose (BD-Day 29) compared with 28 days following second dose (Part A-Day 57)||1.8|0.1|
71702879|NCT01179516|142922830|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.488||0.597|TWO_SIDED|95.0|-3.71|2.14||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure for each dose was applied to compare 10 mg and 15 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||2.14|-3.71|0.597
71702880|NCT01179516|142922830|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|1.501||0.745|TWO_SIDED|95.0|-3.44|2.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||2.46|-3.44|0.745
71702881|NCT01179516|142922831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.232||||0.396|TWO_SIDED|95.0|0.761|1.995|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.995|0.761|0.396
71702882|NCT01179516|142922831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.212||||0.435|TWO_SIDED|95.0|0.748|1.963|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.963|0.748|0.435
71702883|NCT01179516|142922832|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.149||0.554|TWO_SIDED|95.0|-0.38|0.21|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.21|-0.38|0.554
71702884|NCT01179516|142922832|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.151||0.739|TWO_SIDED|95.0|-0.35|0.25|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.25|-0.35|0.739
71702885|NCT01179516|142922833|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|2.261||0.67|TWO_SIDED|95.0|-5.43|3.5|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||3.50|-5.43|0.670
71702886|NCT01179516|142922833|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.295||0.451|TWO_SIDED|95.0|-2.8|6.26|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||6.26|-2.80|0.451
71702887|NCT01179516|142922834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.291||||0.352|TWO_SIDED|95.0|0.754|2.211|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||2.211|0.754|0.352
71702888|NCT01179516|142922834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116||||0.694|TWO_SIDED|95.0|0.646|1.928|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.||||1.928|0.646|0.694
71702889|NCT01179516|142922835|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|1.25||0.464|TWO_SIDED|95.0|-3.38|1.55|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.55|-3.38|0.464
71702890|NCT01179516|142922835|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|1.322||0.6|TWO_SIDED|95.0|-1.91|3.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||3.30|-1.91|0.600
71702891|NCT02337946|142922863|SUPERIORITY||Difference of PFS rate between groups|0.9|||||TWO_SIDED|95.0|-17.2|19.0|||||||Agresti-Caffo method was used for estimation of 95% CI.|19.0|-17.2|
71702892|NCT02337946|142922864|SUPERIORITY||Adjusted Hazard Ratio (HR)|0.93||||0.7349|TWO_SIDED|95.0|0.6|1.43|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.43|0.60|0.7349
71824439|NCT03852433|143152939|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
71702893|NCT02337946|142922865|SUPERIORITY||Adjusted Hazard Ratio (HR)|1.41||||0.3485|TWO_SIDED|95.0|0.69|2.88|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||2.88|0.69|0.3485
71824440|NCT03852433|143152939|OTHER||Difference in percentages|15.3||||0.2631|TWO_SIDED|95.0|-8.2|34.2|||Fisher Exact|||||34.2|-8.2|0.2631
71824441|NCT03852433|143152939|OTHER||Difference in percentages|29.3||||0.0197|TWO_SIDED|95.0|1.8|48.2|||Fisher Exact|||||48.2|1.8|0.0197
71650847|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.946|STANDARD_ERROR_OF_MEAN|2.997||0.19||95.0|-1.979|9.871|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||9.871|-1.979|0.1900
71650848|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|3.693||0.2365||95.0|-3.004|11.865|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||11.865|-3.004|0.2365
71650849|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.306|STANDARD_ERROR_OF_MEAN|3.73||0.1616||95.0|-2.202|12.814|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||12.814|-2.202|0.1616
71650850|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.071|STANDARD_ERROR_OF_MEAN|6.911||0.8819||95.0|-17.98|15.838|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||15.838|-17.98|0.8819
71650851|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.071|STANDARD_ERROR_OF_MEAN|11.7||0.4676||95.0|-37.7|19.558|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||19.558|-37.70|0.4676
71650852|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.925|STANDARD_ERROR_OF_MEAN|2.195||0.3813||95.0|-2.403|6.254|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.254|-2.403|0.3813
71650853|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.341|STANDARD_ERROR_OF_MEAN|2.236||0.2966||95.0|-2.07|6.751|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||6.751|-2.070|0.2966
71650854|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.962|STANDARD_ERROR_OF_MEAN|2.576||0.4474||95.0|-3.122|7.046|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.046|-3.122|0.4474
71650855|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.316|STANDARD_ERROR_OF_MEAN|2.59||0.0416||95.0|0.204|10.427|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.427|0.204|0.0416
71650856|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.372|STANDARD_ERROR_OF_MEAN|2.566||0.5935||95.0|-3.694|6.438|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||6.438|-3.694|0.5935
71650857|NCT00442546|142819620|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.272|STANDARD_ERROR_OF_MEAN|2.674||0.3966||95.0|-3.006|7.551|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.551|-3.006|0.3966
71886473|NCT00848354|143293344|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71650858|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.729|STANDARD_ERROR_OF_MEAN|2.631||0.5117||95.0|-3.457|6.916|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||6.916|-3.457|0.5117
71650859|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.532|STANDARD_ERROR_OF_MEAN|2.675||0.0154||95.0|1.258|11.805|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours||11.805|1.258|0.0154
71650860|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.901|STANDARD_ERROR_OF_MEAN|2.353||0.7022||95.0|-3.738|5.54|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||5.540|-3.738|0.7022
71650861|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.509|STANDARD_ERROR_OF_MEAN|2.343||0.0557||95.0|-0.11|9.129|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours||9.129|-0.110|0.0557
71650862|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.171|STANDARD_ERROR_OF_MEAN|2.552||0.2161||95.0|-1.874|8.215|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||8.215|-1.874|0.2161
71650863|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.135|STANDARD_ERROR_OF_MEAN|2.548||0.0058||95.0|2.098|12.172|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours||12.172|2.098|0.0058
71650864|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.185|STANDARD_ERROR_OF_MEAN|3.993||0.1283||95.0|-1.853|14.223|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||14.223|-1.853|0.1283
71650865|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.173|STANDARD_ERROR_OF_MEAN|4.033||0.008||95.0|3.056|19.291|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours||19.291|3.056|0.0080
71650866|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.941|STANDARD_ERROR_OF_MEAN|2.15||0.0018||95.0|7.414|18.468|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||18.468|7.414|0.0018
71650867|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.941|STANDARD_ERROR_OF_MEAN|3.533||0.0038||95.0|8.859|27.023|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours||27.023|8.859|0.0038
71702894|NCT02337946|142922867|SUPERIORITY||Multivariable Hazard Ratio (HR)|0.9||||0.5901|TWO_SIDED|95.0|0.6|1.33|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.||||1.33|0.60|0.5901
71650868|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.125|STANDARD_ERROR_OF_MEAN|2.115||0.5953||95.0|-3.045|5.296|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||5.296|-3.045|0.5953
71650869|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.331|STANDARD_ERROR_OF_MEAN|2.172||0.1267||95.0|-0.952|7.613|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||7.613|-0.952|0.1267
71650870|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.617|STANDARD_ERROR_OF_MEAN|2.339||0.2647||95.0|-1.997|7.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||7.231|-1.997|0.2647
71650871|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.771|STANDARD_ERROR_OF_MEAN|2.421||0.0181||95.0|0.995|10.548|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.548|0.995|0.0181
71702895|NCT02949934|142922876|SUPERIORITY|||||||0.013|||||||ANCOVA|Covariates were age, baseline AUDIT score, baseline drinks per day, and whether participant participated before vs. during the COVID-19 pandemic.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group.||||0.013
71702896|NCT02949934|142922877|SUPERIORITY|||||||0.014|||||||ANCOVA|Covariates were age, baseline AUDIT score, and baseline drinks per day.||Analysis was an ANCOVA testing the interaction between rs4680 genotype and medication group||||0.014
71702897|NCT02949934|142922878|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.062
71702898|NCT02949934|142922879|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Linear mixed model testing interaction between rs4680 genotype, medication group, and time, controlling for scanner||||||0.83
71702899|NCT02949934|142922879|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|Linear mixed model testing interaction between medication group and time, controlling for scanner||||||0.026
71702900|NCT03720847|142922880|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.012|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|||||.012
71702901|NCT03720847|142922881|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.03|TWO_SIDED||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates a greater perimenstrual increase in the outcome in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.030
71702902|NCT03720847|142922882|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.013|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.013
71702903|NCT03720847|142922883|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.018|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual change in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.018
71702904|NCT03720847|142922884|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.073|TWO_SIDED||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.073
71702905|NCT03720847|142922885|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.25|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.25
71702906|NCT03720847|142922886|SUPERIORITY||Mean Difference (Final Values)|-1.32||||0.23|TWO_SIDED||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.||||.23
71702907|NCT02734667|142922907|SUPERIORITY||t statistic from GLM/regression|-0.47||||0.64|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.64
71702908|NCT02734667|142922908|SUPERIORITY||t-statistic from GLM/regression results|-2.6||||0.013|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.013
71702909|NCT02734667|142922909|SUPERIORITY||t-statistic from GLM/regression results|3.12||||0.003|TWO_SIDED|||||Generalized linear models were used to compare outcomes between the CGM and control groups at 6 months while adjusting for participant gender, age, annual household income, days since diagnosis, and baseline A1c.|Regression, Linear|||||||0.003
71702910|NCT00195429|142922937|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.0
71650872|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.374|STANDARD_ERROR_OF_MEAN|2.299||0.5507||95.0|-3.161|5.91|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||5.910|-3.161|0.5507
71702911|NCT00195429|142922938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Student's t-test|||||||0.361
71702912|NCT04925934|142922981|SUPERIORITY||Rate Difference|2.8|||=|0.7474|TWO_SIDED|90.0|-11.4|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.4|=0.7474
71702913|NCT04925934|142922981|SUPERIORITY||Rate Difference|-0.1|||=|0.9942|TWO_SIDED|90.0|-14.2|14.1|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||14.1|-14.2|=0.9942
71702914|NCT04925934|142922982|SUPERIORITY||Rate Difference|37.2|||=|0.1626|TWO_SIDED|90.0|-0.3|74.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||74.7|-0.3|=0.1626
71702915|NCT04925934|142922982|SUPERIORITY||Rate Difference|24.1|||=|0.2873|TWO_SIDED|90.0|-7.5|55.8|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.||55.8|-7.5|=0.2873
71824442|NCT03852433|143152939|OTHER||Difference in percentages|-4.7||||0.7186|TWO_SIDED|95.0|-26.3|11.8|||Fisher Exact|||||11.8|-26.3|0.7186
71650873|NCT00442546|142819621|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|2.393||0.3164||95.0|-2.317|7.124|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||7.124|-2.317|0.3164
71650874|NCT00442546|142819622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4365||95.0|||||Log Rank|||||||0.4365
71650875|NCT00442546|142819622|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||95.0|||||Log Rank|||||||0.4023
71650876|NCT00442546|142819623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024||95.0|||||Log Rank|||||||0.4024
71650877|NCT00442546|142819623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0|||||Log Rank|||||||0.1910
71650878|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.347|STANDARD_ERROR_OF_MEAN|2.497||0.3483||95.0|-2.573|7.268|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||7.268|-2.573|0.3483
71650879|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.155|STANDARD_ERROR_OF_MEAN|2.498||0.2078||95.0|-1.766|8.077|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.077|-1.766|0.2078
71650880|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.126|STANDARD_ERROR_OF_MEAN|6.436||0.4299||95.0|-7.836|18.088|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.088|-7.836|0.4299
71650881|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.146|STANDARD_ERROR_OF_MEAN|6.726||0.4482||95.0|-8.4|18.693|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||18.693|-8.400|0.4482
71650882|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.036|STANDARD_ERROR_OF_MEAN|4.426||0.6472||95.0|-6.818|10.89|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||10.890|-6.818|0.6472
71650883|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.156|STANDARD_ERROR_OF_MEAN|4.642||0.4992||95.0|-6.129|12.442|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.442|-6.129|0.4992
71650884|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.656|STANDARD_ERROR_OF_MEAN|5.149||0.6072||95.0|-7.578|12.891|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.891|-7.578|0.6072
71650885|NCT00442546|142819624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.963|STANDARD_ERROR_OF_MEAN|4.906||0.3146||95.0|-4.789|14.714|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.714|-4.789|0.3146
71650886|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.177|STANDARD_ERROR_OF_MEAN|2.326||0.0739||95.0|-0.407|8.76|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.760|-0.407|0.0739
71650887|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.176|STANDARD_ERROR_OF_MEAN|2.327||0.074||95.0|-0.409|8.761|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.761|-0.409|0.0740
71650888|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.298|STANDARD_ERROR_OF_MEAN|6.418||0.2615||95.0|-5.628|20.224|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||20.224|-5.628|0.2615
71650889|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.286|STANDARD_ERROR_OF_MEAN|6.707||0.6266||95.0|-10.22|16.795|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||16.795|-10.22|0.6266
71650890|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.17|STANDARD_ERROR_OF_MEAN|3.958||0.2963||95.0|-3.747|12.086|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||12.086|-3.747|0.2963
71650891|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.248|STANDARD_ERROR_OF_MEAN|4.151||0.1375||95.0|-2.054|14.55|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||14.550|-2.054|0.1375
71650892|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.431|STANDARD_ERROR_OF_MEAN|4.895||0.2703||95.0|-4.298|15.161|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||15.161|-4.298|0.2703
71650893|NCT00442546|142819625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.663|STANDARD_ERROR_OF_MEAN|4.664||0.104||95.0|-1.607|16.933|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||16.933|-1.607|0.1040
71650894|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.579|STANDARD_ERROR_OF_MEAN|3.154||0.8545||95.0|-5.635|6.793|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||6.793|-5.635|0.8545
71650895|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|3.155||0.5006||95.0|-4.088|8.344|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||8.344|-4.088|0.5006
71650896|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|8.248||0.7217||95.0|-13.66|19.569|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||19.569|-13.66|0.7217
71650897|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.011|STANDARD_ERROR_OF_MEAN|8.62||0.4203||95.0|-10.35|24.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||24.372|-10.35|0.4203
71650898|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.6||0.9859||95.0|-11.3|11.102|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.102|-11.30|0.9859
71650899|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|5.873||0.9915||95.0|-11.68|11.811|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||11.811|-11.68|0.9915
71650900|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|6.508||0.9843||95.0|-13.06|12.808|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||12.808|-13.06|0.9843
71650901|NCT00442546|142819626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.351|STANDARD_ERROR_OF_MEAN|6.201||0.7055||95.0|-9.974|14.677|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||14.677|-9.974|0.7055
71650902|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.315||0.9405||95.0|-0.614|0.661|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.661|-0.614|0.9405
71650903|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.287||0.5641||95.0|-0.749|0.415|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.415|-0.749|0.5641
71650904|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
71650905|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
71824443|NCT03852433|143152939|OTHER||Difference in percentages|14.0||||0.2184|TWO_SIDED|95.0|-5.5|32.7|||Fisher Exact|||||32.7|-5.5|0.2184
71650906|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.328|STANDARD_ERROR_OF_MEAN|0.882||0.1925||95.0|-3.596|0.94|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||0.940|-3.596|0.1925
71650907|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.982||0.9654||95.0|-2.568|2.479|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||2.479|-2.568|0.9654
71650908|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.352|STANDARD_ERROR_OF_MEAN|1.782||0.235||95.0|-6.712|2.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.008|-6.712|0.2350
71650909|NCT00442546|142819627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.859||0.742||95.0|-1.806|2.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.399|-1.806|0.7420
71650910|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.329||0.5299||95.0|-0.458|0.874|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.874|-0.458|0.5299
71650911|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.355|STANDARD_ERROR_OF_MEAN|0.3||0.2442||95.0|-0.964|0.253|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge||0.253|-0.964|0.2442
71650912|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||2.181|-1.181|0.5226
71650913|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.167|STANDARD_ERROR_OF_MEAN|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2||1.823|-2.156|0.8557
71650914|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.119|STANDARD_ERROR_OF_MEAN|1.024||0.324||95.0|-3.751|1.512|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||1.512|-3.751|0.3240
71650915|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|1.139||0.9503||95.0|-2.853|3.003|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4||3.003|-2.853|0.9503
71650916|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.833|STANDARD_ERROR_OF_MEAN|1.858||0.3618||95.0|-6.379|2.712|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.712|-6.379|0.3618
71650917|NCT00442546|142819628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.896||0.7226||95.0|-1.859|2.525|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET||2.525|-1.859|0.7226
71650918|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.2473
71650919|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0239||95.0|||||Cochran-Mantel-Haenszel|||Discharge||||0.0239
71650920|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6118||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6118
71650921|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|||Week 2||||0.6730
71650922|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5954||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.5954
71650923|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7784||95.0|||||Cochran-Mantel-Haenszel|||Week 4||||0.7784
71650924|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7293||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.7293
71650925|NCT00442546|142819629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5202||95.0|||||Cochran-Mantel-Haenszel|||Week 6/ET||||0.5202
71650926|NCT00442546|142819630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1509||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.1509
71650927|NCT00442546|142819630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3822||95.0|||||Cochran-Mantel-Haenszel|||Month 3||||0.3822
71650928|NCT00442546|142819630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2825||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.2825
71650929|NCT00442546|142819630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7733||95.0|||||Cochran-Mantel-Haenszel|||Month 6||||0.7733
71650930|NCT02000531|142819661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26|||>|0.05|TWO_SIDED|95.0|0.61|2.62|||Log Rank|||||2.62|0.61|>0.05
71650931|NCT01239472|142819669|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71650932|NCT01239472|142819670|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71650933|NCT01280617|142819687|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Continuous variables analyzed using 2-tailed t test or Mann Whitney tes.. Categorical variables analyzed using Chi-Square or Fisher's Exact test||||||<0.05
71650934|NCT01280617|142819687|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71650935|NCT05966090|142819689|NON_INFERIORITY|Non - Inferiority (NI) was to be demonstrated if the upper limit of the 2 sided 95% confidence interval (CI) of the GMC ratio between the Control group (at Day 91) versus Co-administration group (at Day 91) for anti-gE Ab 1-month after the second HZ/su vaccine dose was \<=1.5.|Ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed concentration, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate non-inferiority of the humoral immune response to 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with RSVPreF3 OA investigational vaccine, compared to 2 doses of HZ/su vaccine administered alone.||1.42|1.08|
71650936|NCT05966090|142819690|NON_INFERIORITY|NI was to be demonstrated if upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5|ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.35|0.97|
71702916|NCT04925934|142922983|SUPERIORITY||Rate Difference|8.6|||=|0.322|TWO_SIDED|90.0|-5.6|22.7|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||22.7|-5.6|=0.3220
71824444|NCT03852433|143152939|OTHER||Difference in percentages|-20.0||||0.0283|TWO_SIDED|95.0|-36.1|-3.5|||Fisher Exact|||||-3.5|-36.1|0.0283
71824445|NCT03852433|143152942|OTHER||Difference in percentages|26.0||||0.0134|TWO_SIDED|95.0|6.0|44.0|||Fisher Exact|||||44.0|6.0|0.0134
71824446|NCT03852433|143152943|OTHER||Difference in percentages|28.0||||0.0049|TWO_SIDED|95.0|8.2|45.1|||Fisher Exact|||||45.1|8.2|0.0049
71824447|NCT03852433|143152944|OTHER||Difference in percentages|34.0||||0.0003|TWO_SIDED|95.0|14.6|50.4|||Fisher Exact|||||50.4|14.6|0.0003
71824448|NCT03852433|143152944|OTHER||Difference in percentages|1.0||||1|TWO_SIDED|95.0|-22.8|21.4|||Fisher Exact|||||21.4|-22.8|1.0000
71824449|NCT03852433|143152944|OTHER||Difference in percentages|21.0||||0.1265|TWO_SIDED|95.0|-5.3|42.2|||Fisher Exact|||||42.2|-5.3|0.1265
71824450|NCT03852433|143152944|OTHER||Difference in percentages|-13.0||||0.1863|TWO_SIDED|95.0|-35.3|5.4|||Fisher Exact|||||5.4|-35.3|0.1863
71824451|NCT03852433|143152944|OTHER||Difference in percentages|20.0||||0.0601|TWO_SIDED|95.0|1.0|38.2|||Fisher Exact|||||38.2|1.0|0.0601
71824452|NCT03852433|143152944|OTHER||Difference in percentages|-14.0||||0.1247|TWO_SIDED|95.0|-29.9|1.7|||Fisher Exact|||||1.7|-29.9|0.1247
71824453|NCT03852433|143152945|OTHER||Difference in LS Mean|1.56||||0.0717|TWO_SIDED|95.0|-0.14|3.26|||MMRM|||||3.26|-0.14|0.0717
71824454|NCT03852433|143152945|OTHER||Difference in LS Mean|-1.84||||0.1563|TWO_SIDED|95.0|-4.39|0.71|||MMRM|||||0.71|-4.39|0.1563
71650937|NCT05966090|142819691|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2 sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer 1-month after the RSVPreF3 OA investigational vaccine dose was \<=1.5.|ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as a covariate.|To demonstrate the non-inferiority of RSVPreF3 OA investigational vaccine when co-administered with the first dose of HZ/su vaccine, compared to RSVPreF3 OA investigational vaccine administered alone.||1.15|0.84|
71650938|NCT00337428|142819705|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650939|NCT00337428|142819706|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650940|NCT00337428|142819707|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650941|NCT00337428|142819708|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650942|NCT00337428|142819709|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650943|NCT00337428|142819710|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650944|NCT00337428|142819711|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650945|NCT00337428|142819712|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650946|NCT00337428|142819713|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650947|NCT00337428|142819714|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650948|NCT00337428|142819715|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71650949|NCT00337428|142819716|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71824455|NCT03852433|143152945|OTHER||Difference in LS Mean|-1.8||||0.1626|TWO_SIDED|95.0|-4.33|0.73|||MMRM|||||0.73|-4.33|0.1626
71824456|NCT03852433|143152945|OTHER||Difference in LS Mean|-3.34||||0.0099|TWO_SIDED|95.0|-5.87|-0.82|||MMRM|||||-0.82|-5.87|0.0099
71824457|NCT03852433|143152945|OTHER||Difference in LS Mean|0.07||||0.9384|TWO_SIDED|95.0|-1.67|1.81|||MMRM|||||1.81|-1.67|0.9384
71824458|NCT03852433|143152945|OTHER||Difference in LS Mean|-1.49||||0.0875|TWO_SIDED|95.0|-3.2|0.22|||MMRM|||||0.22|-3.20|0.0875
71824459|NCT03852433|143152946|OTHER||Difference in LS Mean|0.15||||0.8645|TWO_SIDED|95.0|-1.54|1.83|||MMRM|||||1.83|-1.54|0.8645
71824460|NCT03852433|143152946|OTHER||Difference in LS Mean|-0.33||||0.7033|TWO_SIDED|95.0|-2.06|1.39|||MMRM|||||1.39|-2.06|0.7033
71824461|NCT03852433|143152946|OTHER||Difference in LS Mean|-0.48||||0.5806|TWO_SIDED|95.0|-2.18|1.23|||MMRM|||||1.23|-2.18|0.5806
71824462|NCT03852433|143152947|OTHER||Difference in LS Mean|-1.68||||0.1103|TWO_SIDED|95.0|-3.75|0.39|||MMRM|||||0.39|-3.75|0.1103
71824463|NCT03852433|143152947|OTHER||Difference in LS Mean|-2.05||||0.1533|TWO_SIDED|95.0|-4.88|0.77|||MMRM|||||0.77|-4.88|0.1533
71824464|NCT03852433|143152947|OTHER||Difference in LS Mean|-2.22||||0.1129|TWO_SIDED|95.0|-4.98|0.53|||MMRM|||||0.53|-4.98|0.1129
71824465|NCT03852433|143152947|OTHER||Difference in LS Mean|-0.58||||0.6753|TWO_SIDED|95.0|-3.34|2.17|||MMRM|||||2.17|-3.34|0.6753
71702917|NCT04925934|142922983|SUPERIORITY||Rate Difference|2.9|||=|0.7364|TWO_SIDED|90.0|-11.2|17.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||17.0|-11.2|=0.7364
71702918|NCT04925934|142922984|SUPERIORITY||Rate Difference|11.7|||=|0.2805|TWO_SIDED|90.0|-6.1|29.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||29.4|-6.1|=0.2805
71702919|NCT04925934|142922984|SUPERIORITY||Rate Difference|9.4|||=|0.3926|TWO_SIDED|90.0|-8.6|27.3|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.||27.3|-8.6|=0.3926
71702920|NCT04925934|142922985|SUPERIORITY||Rate Difference|16.5|||=|0.037|TWO_SIDED|90.0|4.0|29.0|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||29.0|4.0|=0.0370
71702921|NCT04925934|142922985|SUPERIORITY||Rate Difference|4.9|||=|0.4939|TWO_SIDED|90.0|-6.7|16.4|||Regression, Logistic|||Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.||16.4|-6.7|=0.4939
71702922|NCT03158688|142922991|SUPERIORITY||Stratified Cox model hazard ratio|0.63||||0.0014|TWO_SIDED|95.0|0.464|0.854||alpha level of 0.025|Log Rank||KdD/Kd|Stratification factors used in the Log-rank p-value (1-sided) and the Cox model hazard ratio (KdD/Kd) were as assessed at randomization: International Staging System stage at screening (Stage 1 or 2 vs Stage 3); prior proteasome inhibitor exposure (yes vs no); number of prior lines of therapy (1 vs \>= 2).||0.854|0.464|0.0014
71702923|NCT03158688|142922992|SUPERIORITY||Odds Ratio (OR)|1.925||||0.004|TWO_SIDED|95.0|1.184|3.129|||Cochran-Mantel-Haenszel||KdD/Kd|"Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.~P-values were calculated using the stratified Cochran-Mantel-Haenszel Chi-Square test."||3.129|1.184|0.0040
71702924|NCT03158688|142922993|SUPERIORITY||Odds Ratio (OR)|7.819|||||TWO_SIDED|95.0|2.364|25.858|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated using the stratified Mantel-Haenszel method.||25.858|2.364|
71824466|NCT03852433|143152947|OTHER||Difference in LS Mean|-0.12||||0.9124|TWO_SIDED|95.0|-2.28|2.04|||MMRM|||||2.04|-2.28|0.9124
71702925|NCT03158688|142922994|SUPERIORITY||Cox Proportional Hazard|0.784||||0.0417|TWO_SIDED|95.0|0.595|1.033|||Log Rank||KdD/Kd|"Hazard ratio and corresponding 95% CIs were estimated using the stratified Cox proportional hazards models.~1-sided p-value from the log-rank test controlling for the randomization stratification factors."||1.033|0.595|0.0417
71702926|NCT03158688|142923003|SUPERIORITY||Odds Ratio (OR)|4.403|||||TWO_SIDED|95.0|2.007|9.656|||||KdD/Kd|Odds ratios and corresponding 95% CIs were estimated by a stratified analysis using the Mantel-Haenszel method.||9.656|2.007|
71702927|NCT03158688|142923004|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|1.24||0.948|TWO_SIDED|95.0|-2.52|2.35|||linear mixed effects model||The overall treatment difference (KdD - Kd)|Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.||2.35|-2.52|0.9480
71702928|NCT04837521|142923019|SUPERIORITY||γ01|0.25||||0.03|TWO_SIDED||||||t-test, 2 sided||analysis completed using the 1 week follow up data|||||.03
71702929|NCT04837521|142923020|OTHER|The conditions were expected to be similar, and the primary interest of the analysis was changes over time across both groups.|Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|2.32|4.49||To estimate the mean improvement in PSFS across the entire sample, we calculated a posterior predictive distribution of within-person change scores between time fixed equal to 0 and equal to -1.|Bayesian framework|||PSFS scores were analyzed using mixed-effects linear growth models with time, treatment condition, and their interaction as predictors. Random effects modeled variation in intercepts, slopes over time, and their covariance. Time was specified as a continuous variable, centered on the final observation date. The SG group served as the reference level for the treatment factor. Models were estimated in a Bayesian framework using default priors in the brms package.||4.49|2.32|
71702930|NCT01944774|142923038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.291||||0.133|TWO_SIDED|95.0|0.058|1.457||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.457|0.058|0.133
71702931|NCT01944774|142923038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.492||||0.423|TWO_SIDED|95.0|0.087|2.788||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.788|0.087|0.423
71702932|NCT01944774|142923039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.276||||0.118|TWO_SIDED|95.0|0.055|1.385||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.385|0.055|0.118
71739292|NCT00999518|142991307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.93|0.47||||||The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.||0.47|-0.93|
71824467|NCT03852433|143152947|OTHER||Difference in LS Mean|1.56||||0.1526|TWO_SIDED|95.0|-0.59|3.7|||MMRM|||||3.70|-0.59|0.1526
71824468|NCT00601965|143152963|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log rank test = 32.67, df = 3||||||<.001
71824469|NCT00601965|143152964|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Beta = -0.48, 95% CI = -0.84 to -0.11||||||0.01
71650950|NCT00337428|142819717|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001||95.0|||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26||||||<0.001
71886474|NCT00848354|143293346|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).||||<0.0001
71650951|NCT00337428|142819718|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650952|NCT00337428|142819719|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650953|NCT00337428|142819720|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650954|NCT00337428|142819721|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71650955|NCT04205162|142819733|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.331
71650956|NCT04205162|142819733|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.122
71650957|NCT04205162|142819734|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Comparison of etafilcon A||||0.130
71650958|NCT04205162|142819734|OTHER|||||||0.924|||||||Wilcoxon (Mann-Whitney)|||Comparison of verofilcon A||||0.924
71650959|NCT03460158|142819736|OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.1524||0.8822|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the relative change in volume and relative change in patient reported outcomes will be the same at 2 weeks post injection||||0.8822
71650960|NCT03460158|142819736|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1466||0.2223|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 4 weeks post injection||||0.2223
71650961|NCT03460158|142819736|OTHER||Mean Difference (Final Values)|-0.369|STANDARD_ERROR_OF_MEAN|0.113||0.0015|TWO_SIDED|95.0|||||t-test, 2 sided|||Two-sample t test with equal variances the null hypothesis is the change in volume and change in patient reported outcomes will be the same at 12 weeks post injection||||0.0015
71650962|NCT01011556|142819738|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.17|||<|0.001|TWO_SIDED|90.0|-8.489|-5.851|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-5.851|-8.489|<0.001
71650963|NCT01011556|142819738|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.48|||<|0.001|TWO_SIDED|90.0|-8.822|-6.144|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-6.144|-8.822|<0.001
71650964|NCT01011556|142819738|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-6.17|||<|0.001|TWO_SIDED|90.0|-7.448|-4.891|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-4.891|-7.448|<0.001
71650965|NCT01011556|142819739|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.58|||<|0.001|TWO_SIDED|90.0|-5.716|-3.452|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-3.452|-5.716|<0.001
71650966|NCT01011556|142819739|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.87|||<|0.001|TWO_SIDED|90.0|-5.006|-2.727|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.727|-5.006|<0.001
71650967|NCT01011556|142819739|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.56|||<|0.001|TWO_SIDED|90.0|-4.652|-2.464|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.||||-2.464|-4.652|<0.001
71650968|NCT01011556|142819740|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-4.53|STANDARD_ERROR_OF_MEAN|0.687|<|0.001|TWO_SIDED|90.0|-5.663|-3.392||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-3.392|-5.663|<0.001
71650969|NCT01011556|142819740|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.94|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|90.0|-5.086|-2.8||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.800|-5.086|<0.001
71650970|NCT01011556|142819740|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.53|STANDARD_ERROR_OF_MEAN|0.665|<|0.001|TWO_SIDED|90.0|-4.627|-2.43||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-2.430|-4.627|<0.001
71650971|NCT01011556|142819740|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.5|STANDARD_ERROR_OF_MEAN|0.818|<|0.001|TWO_SIDED|90.0|-8.856|-6.151||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.151|-8.856|<0.001
71739293|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.259|1.683||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.683|0.259|
71739294|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.975|||||TWO_SIDED|95.0|0.387|2.457||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.457|0.387|
71650972|NCT01011556|142819740|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-7.46|STANDARD_ERROR_OF_MEAN|0.83||0.001|TWO_SIDED|90.0|-8.835|-6.091||p-value for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-6.091|-8.835|0.001
71650973|NCT01011556|142819740|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-6.19|STANDARD_ERROR_OF_MEAN|0.802||0.001|TWO_SIDED|90.0|-7.51|-4.86||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment\*visit interaction. Repeat measure occurred at each visit.||||-4.860|-7.510|0.001
71650974|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71650975|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71650976|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71650977|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71650978|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71650979|NCT01011556|142819741|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.003
71650980|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
71650981|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
71650982|NCT01011556|142819741|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.029
71650983|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
71650984|NCT01011556|142819741|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||<0.001
71650985|NCT01011556|142819741|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.047
71650986|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.822
71650987|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.406
71650988|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.312||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||0.312
71650989|NCT01011556|142819742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71650990|NCT01011556|142819742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||<0.001
71650991|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.||||||0.952
71650992|NCT01011556|142819742|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||<0.001
71650993|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.011
71650994|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.||||||0.997
71650995|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.003
71650996|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.112
71650997|NCT01011556|142819742|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.||||||0.988
71650998|NCT01011556|142819743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71650999|NCT01011556|142819743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71651000|NCT01011556|142819743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.||||||<0.001
71651001|NCT01546519|142819758|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.95|1.78||||||Cmax Mild HI vs. Normal: Based on pooled variance estimates||1.78|0.95|
71651002|NCT01546519|142819758|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|90.0|0.92|1.83||||||Cmax Moderate HI vs. Normal: Based on pooled variance estimates||1.83|0.92|
71651003|NCT01546519|142819758|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.55|1.37||||||Cmax Severe HI vs. Normal: Based on pooled variance estimates||1.37|0.55|
71651004|NCT01546519|142819758|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.9|1.71||||||Css Mild HI vs. Normal: Based on pooled variance estimates||1.71|0.90|
71651005|NCT01546519|142819758|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.89|1.8||||||Css Moderate HI vs. Normal: Based on pooled variance estimates||1.80|0.89|
71651006|NCT01546519|142819758|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.55|1.41||||||Css Severe HI vs. Normal: Based on pooled variance estimates||1.41|0.55|
71651007|NCT01546519|142819759|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|0.89|1.73||||||AUC0-24hr Mild HI vs. Normal: Based on pooled variance estimates||1.73|0.89|
71651008|NCT01546519|142819759|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.91|1.89||||||AUC0-24hr Moderate HI vs. Normal: Based on pooled variance estimates||1.89|0.91|
71651009|NCT01546519|142819759|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.53|1.39||||||AUC0-24hr Severe HI vs. Normal: Based on pooled variance estimates||1.39|0.53|
71651010|NCT02958319|142819767|SUPERIORITY||Median Difference (Final Values)|4.1||||0.82|TWO_SIDED|||||p \< 0.05 was considered statistically significant|GENERAL LINEAL MODEL|GENERAL LINEAL MODEL OF REPEATED MEASURES||||||0.82
71651011|NCT00263887|142819768|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|||The main effect ANCOVA model includes the change from baseline to endpoint as the dependent variable, treatment and center as fixed factors, change in logarithm of total lung volume and baseline measurement as covariates.||||0.049
71702933|NCT01944774|142923039|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.644||||0.636|TWO_SIDED|95.0|0.104|3.999||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||3.999|0.104|0.636
71702934|NCT01944774|142923040|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.517||||0.456|TWO_SIDED|95.0|0.091|2.93||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.930|0.091|0.456
71702935|NCT01944774|142923040|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.508||||0.445|TWO_SIDED|95.0|0.09|2.883||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.883|0.090|0.445
71702936|NCT01944774|142923041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.518||||0.458|TWO_SIDED|95.0|0.091|2.941||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||2.941|0.091|0.458
71702937|NCT01944774|142923041|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.667||||0.664|TWO_SIDED|95.0|0.107|4.144||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.144|0.107|0.664
71702938|NCT01944774|142923042|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.959|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.959
71702939|NCT01944774|142923042|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.961|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.961
71702940|NCT01944774|142923043|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.96|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.960
71702941|NCT01944774|142923043|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
71702942|NCT01944774|142923044|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.95|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.950
71702943|NCT01944774|142923044|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
71702944|NCT01944774|142923045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.949|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.949
71702945|NCT01944774|142923045|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.962|TWO_SIDED|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (\<0.001, \>999.999).|||||0.962
71702946|NCT01944774|142923046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.438||||0.491|TWO_SIDED|95.0|0.042|4.609||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.609|0.042|0.491
71702947|NCT01944774|142923046|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.531||||0.619|TWO_SIDED|95.0|0.044|6.444||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.444|0.044|0.619
71702948|NCT01944774|142923047|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.444||||0.501|TWO_SIDED|95.0|0.042|4.708||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||4.708|0.042|0.501
71702949|NCT01944774|142923047|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
71702950|NCT01944774|142923048|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.733||||0.807|TWO_SIDED|95.0|0.061|8.832||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.832|0.061|0.807
71702951|NCT01944774|142923048|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
71762765|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|<0.0001
71762766|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.26|0.39||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.39|0.26|<0.0001
71702952|NCT01944774|142923049|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.779|TWO_SIDED|95.0|0.058|8.445||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||8.445|0.058|0.779
71702953|NCT01944774|142923049|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.567||||0.656|TWO_SIDED|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||6.895|0.047|0.656
71824470|NCT02138916|143152965|SUPERIORITY||Rate ratio|0.96||||0.649|TWO_SIDED|95.0|0.8|1.15|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.15|0.8|0.6490
71824471|NCT02138916|143152965|SUPERIORITY||Risk Ratio (RR)|0.83||||0.0525|TWO_SIDED|95.0|0.69|1.0|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.00|0.69|0.0525
71824472|NCT02138916|143152966|SUPERIORITY||Risk Ratio (RR)|1.07||||0.5236|TWO_SIDED|95.0|0.86|1.34|||Negative binomial|Model includes treatment group, region, number of exacerbations in the previous year.||||1.34|0.86|0.5236
71824473|NCT02138916|143152966|SUPERIORITY||Risk Ratio (RR)|1.02||||0.8812|TWO_SIDED|95.0|0.82|1.27|||Negative binomial|Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.||||1.27|0.82|0.8812
71824474|NCT02138916|143152967|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.755|TWO_SIDED|95.0|-0.035|0.048|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.048|-0.035|0.7550
71651012|NCT00779402|142819775|OTHER||Hazard Ratio (HR)|0.997||||0.65|TWO_SIDED|95.0|0.693|1.433|||Log Rank|Log Rank Test (two sided) stratified by Gleason Score and Radiation Therapy||||1.433|0.693|0.65
71702954|NCT03188185|142923050|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05 .|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.99||0.128|TWO_SIDED|95.0|-3.5|0.4||ALK 5461 was compared to placebo using stage-specific MMRM for MADRS-10 Change from Baseline.Model-derived estimates were combined using equal weights|Mixed Models Analysis|||Analysis was conducted for each stage separately, and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2).||0.4|-3.5|0.128
71702955|NCT02232698|142923074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.239|<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71824475|NCT02138916|143152967|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.3285|TWO_SIDED|95.0|-0.021|0.062|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.062|-0.021|0.3285
71824476|NCT02138916|143152968|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.2906|TWO_SIDED|95.0|-2.887|0.865|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.865|-2.887|0.2906
71824477|NCT02138916|143152968|SUPERIORITY||Mean Difference (Final Values)|-2.136||||0.0264|TWO_SIDED|95.0|-4.02|-0.251|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.251|-4.020|0.0264
71651013|NCT04364763|142819797|SUPERIORITY|||||||0.0352||||||p-value is for Day 7|Mixed Models Analysis|||||||0.0352
71702956|NCT02232698|142923075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9556|TWO_SIDED||||||ANCOVA|||||||0.9556
71702957|NCT02232698|142923076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.175|<|0.0001|TWO_SIDED|||||Statistical analysis of time spent \<55 mg/dL|ANCOVA|||||||<0.0001
71702958|NCT02232698|142923076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.122||0.0003|TWO_SIDED|||||Statistical analysis of time spent \<40 mg/dL|ANCOVA|||||||0.0003
71702959|NCT02232698|142923077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||<0.0001
71824478|NCT02138916|143152969|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.6782|TWO_SIDED|95.0|-1.08|0.7|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.70|-1.08|0.6782
71824479|NCT02138916|143152969|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.0753|TWO_SIDED|95.0|-1.7|0.08|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.08|-1.70|0.0753
71824480|NCT02138916|143152970|SUPERIORITY||Mean Difference (Final Values)|-0.585||||0.0889|TWO_SIDED|95.0|-1.26|0.089|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.089|-1.260|0.0889
71824481|NCT02138916|143152970|SUPERIORITY||Mean Difference (Final Values)|-0.703||||0.0413|TWO_SIDED|95.0|-1.378|-0.028|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.028|-1.378|0.0413
71824482|NCT02138916|143152971|SUPERIORITY||Mean Difference (Final Values)|-0.348||||0.0728|TWO_SIDED|95.0|-0.728|0.032|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.032|-0.728|0.0728
71824483|NCT02138916|143152971|SUPERIORITY||Mean Difference (Final Values)|-0.487||||0.0121|TWO_SIDED|95.0|-0.868|-0.107|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.107|-0.868|0.0121
71651014|NCT04364763|142819797|SUPERIORITY|||||||0.235||||||p-value is for Day 28|Mixed Models Analysis|||Comparison made for Day 7 and Day 28||||0.2350
71651015|NCT01386125|142819798|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.14||||0.0007|TWO_SIDED|95.0|-0.22|-0.06|||ANCOVA|||||-0.06|-0.22|0.0007
71651016|NCT01386125|142819799|SUPERIORITY_OR_OTHER_LEGACY||Difference is LS Means|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Constrained longitudinal data analysis|||||-0.15|-0.45|<0.0001
71824484|NCT02138916|143152972|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0235|TWO_SIDED|95.0|-0.077|-0.006|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.006|-0.077|0.0235
71824485|NCT02138916|143152972|SUPERIORITY||Mean Difference (Final Values)|-0.044||||0.0158|TWO_SIDED|95.0|-0.08|-0.008|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.008|-0.080|0.0158
71702960|NCT02232698|142923077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||<0.0001
71702961|NCT02232698|142923077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<40 mg/dL||||<0.0001
71702962|NCT02232698|142923078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.329||0.5623|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5623
71702963|NCT02232698|142923078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.163||0.0247|TWO_SIDED||||||ANCOVA|||Statistical analysis for time spent \>240 mg/dL||||0.0247
71702964|NCT02232698|142923079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0006|TWO_SIDED||||||ANCOVA|||||||0.0006
71702965|NCT02232698|142923082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hyperglycaemia||||<0.0001
71702966|NCT02232698|142923082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0713|TWO_SIDED||||||ANCOVA|||Statistical analysis of perceived frequency of hypoglycaemia||||0.0713
71702967|NCT02232698|142923082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED||||||ANCOVA|||Statistical analysis of total treatment satisfaction score||||<0.0001
71702968|NCT03491917|142923109|NON_INFERIORITY|Non-inferiority margin is delta = 0.05.|||||<|0.01||||||The average difference in AUC was 0.023 (two-sided 95% CI: -0.012, 0.059; non-inferiority p \< 0.01 for non-inferiority margin delta = -0.05).|t-test, 2 sided|df: 417.0 for FFDM, 424.6 for DBT plus S-View, and (1, 18.9) for the difference.||The primary endpoint for this study was a non-inferior per-subject average area under the receiver operating characteristic (ROC) curve (AUC) requiring correct lesion localization for DBT (digital breast tomosynthesis) plus S-View (synthesized view) versus FFDM (full field digital mammography). AUCs for each reader were estimated in each review condition based on per-subject probability of malignancy (POM) scores requiring correct lesion localization.||||<0.01
71702969|NCT01068912|142923123|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||A step-down approach was applied to the primary analysis, with the higher dose of favipiravir first tested against placebo.|Gehan-Wilcoxon|||Time required from first study drug administration to alleviation of the 6 primary influenza symptoms and fever. The primary influenza symptoms included cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Symptoms were considered alleviated when all were decreased to ≤1 and decrease persisted unchanged ≥ 21.5 hours. Fever was considered alleviated when maintained at \< 38.0°C (age 20 to \< 65 years) or \< 37.8°C (age ≥ 65 years) ≥ 21.5 hours.||||.05
71702970|NCT04822194|142923124|SUPERIORITY|||||||0.053|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously reported for within and between-subjects behavioral analyses of longitudinal reappraisal training data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects require 36 per group.||||0.053
71702971|NCT04822194|142923125|SUPERIORITY|||||||0.741|||||||Mixed Models Analysis|Ran linear mixed models on natural log of RMSSD, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups. Power analyses using an approximate effect size (d=.70) previously obtained for within and between-subjects analyses of respiratory sinus arrhythmia data indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=.05) to detect between-group effects should be achieved with 36 per group.||||0.741
71702972|NCT04822194|142923126|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Ran linear mixed model, p-value above reflects a group by session interaction.||Null hypothesis: no difference between groups. Power analyses using a within-subject fMRI effect size estimate for right amygdala affective reactivity from a meta-analysis of Human Connectome Project data of approx. d=.70, applying to between-subjects effects as well, indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) to detect between-group effects should be achieved with 36 participants per group.||||0.021
71702973|NCT04822194|142923127|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|We ran linear mixed models, p-value reflects a group by session interaction for the UGRS composite scores.||Null hypothesis: no difference between groups. Power analyses of an effect size (d=.70) previously reported for within and between-subjects analyses of questionnaire outcomes (i.e., depressive symptoms, grief rumination, perceived stress, reappraisal usage) indicate over 95% power (α=.05) to detect within-group effects and 90% power (α=0.05) for between-group effects should be achieved with 36 per group.||||0.724
71702974|NCT04822194|142923127|SUPERIORITY|||||||0.835|||||||Mixed Models Analysis|Ran linear mixed model on counterfactuals adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.835
71702975|NCT04822194|142923127|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Ran linear mixed model on injustice adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.090
71824486|NCT02138916|143152976|SUPERIORITY||Rate ratio|1.09||||0.408|TWO_SIDED|95.0|0.89|1.34|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.34|0.89|0.4080
71824487|NCT02138916|143152976|SUPERIORITY||Rate ratio|0.98||||0.8688|TWO_SIDED|95.0|0.8|1.21|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.21|0.80|0.8688
71702976|NCT04822194|142923127|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|Ran linear mixed model on meaning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.983
71702977|NCT04822194|142923127|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Ran linear mixed model on reaction adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.760
71702978|NCT04822194|142923127|SUPERIORITY|||||||0.402|||||||Mixed Models Analysis|Ran linear mixed model on relations adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups.||||0.402
71824488|NCT02138916|143152977|SUPERIORITY||Odds Ratio (OR)|0.9||||0.485|TWO_SIDED|95.0|0.66|1.22|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.22|0.66|0.4850
71824489|NCT02138916|143152977|SUPERIORITY||Odds Ratio (OR)|0.89||||0.4489|TWO_SIDED|95.0|0.65|1.21|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.21|0.65|0.4489
71824490|NCT02138916|143152979|SUPERIORITY||Rate ratio|1.06||||0.7733|TWO_SIDED|95.0|0.73|1.53|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.53|0.73|0.7733
71824491|NCT02138916|143152979|SUPERIORITY||Rate ratio|0.58||||0.0114|TWO_SIDED|95.0|0.39|0.89|||Nagative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.89|0.39|0.0114
71824492|NCT02926937|143153093|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.975|-0.415|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.415|-0.975|<0.0001
71824493|NCT02926937|143153094|SUPERIORITY||Difference in LS Mean|-0.565||||0.0141|TWO_SIDED|95.0|-1.0166|-0.114|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||-0.1140|-1.0166|0.0141
71824494|NCT02926937|143153095|SUPERIORITY||Difference in LS Mean|-0.346||||0.2081|TWO_SIDED|95.0|-0.8853|0.1928|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups under Amendment 1 randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, country, treatment-by-country as fixed effects, and baseline HbA1c as a covariate.||0.1928|-0.8853|0.2081
71651017|NCT01201486|142819866|SUPERIORITY_OR_OTHER||Percentage Sensitivity|23.0|||||TWO_SIDED||||||Percentage Sensitivity|||||||
71651018|NCT03604549|142819867|SUPERIORITY||Risk Ratio (RR)|0.44||||0.1|TWO_SIDED|95.0|0.16|1.25|||Chi-squared||Lipiodol UF is the numerator and Saline is the denominator for RR|||1.25|0.16|0.10
71651019|NCT03604549|142819868|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.96|TWO_SIDED|95.0|-1.59|1.68|||t-test, 2 sided||Difference reported as Lipiodol UF - Saline|||1.68|-1.59|0.96
71651020|NCT00436917|142819889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Kruskal-Wallis|||A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.||||0.01
71651021|NCT02438540|142819906|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71824495|NCT02926937|143153096|SUPERIORITY||Difference in LS Mean|-1.556|||<|0.0001|TWO_SIDED|95.0|-2.1876|-0.9234|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥ 130mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.9234|-2.1876|<0.0001
71651022|NCT02438540|142819907|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651023|NCT02438540|142819908|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651024|NCT02438540|142819909|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651025|NCT02438540|142819910|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|90.0|||||ANOVA|||||||0.04
71651026|NCT02438540|142819911|NON_INFERIORITY_OR_EQUIVALENCE|multiple comparatives||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
71824496|NCT02926937|143153097|SUPERIORITY||Difference in LS Mean|-3.5||||0.168|TWO_SIDED|95.0|-8.478|1.476|||ANCOVA|||The change from baseline to Week 12 is analyzed using analysis ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening and country as fixed effects, and baseline SBP as a covariate.||1.476|-8.478|0.1680
71824497|NCT02926937|143153098|SUPERIORITY||Difference in LS Mean|-0.78||||0.5467|TWO_SIDED|95.0|-3.311|1.753|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.753|-3.311|0.5467
71824498|NCT02926937|143153099|SUPERIORITY||Difference in LS Mean|-3.19||||0.0193|TWO_SIDED|95.0|-5.869|-0.518|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-0.518|-5.869|0.0193
71651027|NCT02438540|142819911|NON_INFERIORITY_OR_EQUIVALENCE|from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
71651028|NCT02438540|142819911|NON_INFERIORITY_OR_EQUIVALENCE|from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082|TWO_SIDED|90.0||||CRP is known to be an independent parameter|ANOVA|||||||0.082
71651029|NCT02438540|142819912|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651030|NCT02438540|142819913|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651031|NCT02438540|142819914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651032|NCT02438540|142819915|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651033|NCT02438540|142819916|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651034|NCT02438540|142819917|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651035|NCT02438540|142819918|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651036|NCT02438540|142819919|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651037|NCT02438540|142819920|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651038|NCT02438540|142819921|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71702979|NCT04822194|142923128|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|We ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.092
71702980|NCT04822194|142923129|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|Ran a linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.585
71702981|NCT04822194|142923130|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Ran linear mixed model, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.70
71702982|NCT04822194|142923131|SUPERIORITY|||||||0.696|||||||Mixed Models Analysis|Ran linear mixed model on emotional problems adjusted for covariates, p-value above reflects group by session interaction||Null hypothesis: no difference between groups.||||0.696
71702983|NCT04822194|142923131|SUPERIORITY|||||||0.452|||||||Mixed Models Analysis|Ran linear mixed model on emotional well-being adjusted for covariates, p-value reflects group by session interaction||Null hypothesis: no difference between groups||||0.452
71702984|NCT04822194|142923131|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|Ran a linear mixed model on energy adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.650
71702985|NCT04822194|142923131|SUPERIORITY|||||||0.224|||||||Mixed Models Analysis|Ran linear mixed model on general health perceptions adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.224
71702986|NCT04822194|142923131|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|Ran linear mixed model on pain adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference in groups||||0.256
71702987|NCT04822194|142923131|SUPERIORITY|||||||0.984|||||||Mixed Models Analysis|Ran linear mixed model on physical function adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.984
71702988|NCT04822194|142923131|SUPERIORITY|||||||0.363|||||||Mixed Models Analysis|Ran linear mixed model on physical health adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.363
71651039|NCT02438540|142819922|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71702989|NCT04822194|142923131|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|Ran linear mixed model on social functioning adjusted for covariates, p-value above reflects group by session interaction.||Null hypothesis: no difference between groups||||0.045
71824499|NCT02926937|143153100|SUPERIORITY||Difference in LS Mean|-1.54||||0.0005|TWO_SIDED|95.0|-2.404|-0.676|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.676|-2.404|0.0005
71702990|NCT04822194|142923132|SUPERIORITY|||||||0.422|||||||ANCOVA|Ran a repeated measures ANCOVA of logged IL-6 serum, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.422
71702991|NCT04822194|142923132|SUPERIORITY|||||||0.438|||||||ANCOVA|Ran a repeated measures ANCOVA of TNFα, p-value above reflects time by ER group interaction effect.||Null hypothesis: no difference between groups||||0.438
71702992|NCT00248547|142923142|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon Rank Sum Test|||||||0.041
71824500|NCT02926937|143153101|SUPERIORITY||Difference in LS Mean|-1.17||||0.0406|TWO_SIDED|95.0|-2.281|-0.05|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.050|-2.281|0.0406
71651040|NCT02438540|142819923|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|90.0|||||ANOVA|||||||<0.001
71651041|NCT05070390|142819925|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.62|2.44|||||GMR and 90% confidence interval (CI) were estimated using a linear mixed effects model and referencing a t-distribution.|||2.44|0.62|
71651042|NCT05070390|142819926|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.63|||||TWO_SIDED|90.0|0.55|4.83|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||4.83|0.55|
71651043|NCT05070390|142819927|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|1.45|||||TWO_SIDED|90.0|0.7|2.99|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||2.99|0.70|
71651044|NCT05070390|142819930|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.41|1.62|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.62|0.41|
71702993|NCT00294398|142923146|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
71702994|NCT02965833|142923148|SUPERIORITY||||||=|0.0073|||||||Mixed Models Analysis|||||||=0.0073
71702995|NCT01590875|142923164|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||no relevant statistical analysis|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||<0.01
71702996|NCT01590875|142923165|EQUIVALENCE|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||kappa statistic|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose||||< 0.01
71702997|NCT01214720|142923169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.86|||Log Rank|||||0.86|0.61|0.0002
71702998|NCT01214720|142923170|SUPERIORITY_OR_OTHER||Difference in Response Rates|3.62||||0.3621|TWO_SIDED|95.0|-4.3|11.6|||Chi-squared|Approximate 95% confidence interval (CI) for difference of two rates using Hauck-Anderson method.||||11.6|-4.3|0.3621
71702999|NCT01214720|142923171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2087||95.0|0.74|1.07|||Log Rank|||||1.07|0.74|0.2087
71739295|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
71824501|NCT02926937|143153102|SUPERIORITY||Percentage Difference|12.6||||0.0037|TWO_SIDED|95.0|4.18|21.02|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||21.02|4.18|0.0037
71651045|NCT05070390|142819931|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.92|||||TWO_SIDED|90.0|0.6|1.42|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.42|0.60|
71651046|NCT05070390|142819934|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
71651047|NCT05070390|142819935|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.82|||||TWO_SIDED|90.0|0.22|3.1|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||3.10|0.22|
71651048|NCT05070390|142819936|OTHER|GMR: Panel A-Moderate RI/Panel B-Healthy controls|GMR|0.38|||||TWO_SIDED|90.0|0.13|1.13|||||GMR and 90% CI were estimated using a linear mixed effects model and referencing a t-distribution.|||1.13|0.13|
71651049|NCT05766787|142819946|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||-0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, sequence, visit, and lens by visit interaction) and random (subject) effects. Difference = LID022821 minus AOHG. Sign is retained with the rounded value.|||-0.01||
71651050|NCT01435928|142819947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.039|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||||0.98|0.45|0.039
71651051|NCT01435928|142819948|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.07|TWO_SIDED|95.0|0.54|1.03|||Log Rank|||||1.03|0.54|0.070
71651052|NCT01435928|142819949|SUPERIORITY_OR_OTHER|||||||0.029|||||||ANCOVA|LOCF||||||0.029
71651053|NCT01435928|142819950|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|LOCF||||||0.015
71651054|NCT01435928|142819951|SUPERIORITY_OR_OTHER|||||||0.218|||||||ANCOVA|LOCF||||||0.218
71651055|NCT01435928|142819952|SUPERIORITY_OR_OTHER|||||||0.021|||||||ANCOVA|LOCF||||||0.021
71651056|NCT01435928|142819953|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|LOCF||||||0.056
71651057|NCT04100096|142819993|SUPERIORITY||Least Square (LS) Mean Difference|-1.02||||0.243|TWO_SIDED|95.0|-2.75|0.7||Comparison was carried out using MMRM, with study center (pooled), treatment group (TG), visit, ADT status, and TG by visit interaction (BVI), gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.70|-2.75|0.2430
71651058|NCT04100096|142819994|SUPERIORITY||LS Mean Difference|-0.04||||0.7759|TWO_SIDED|95.0|-0.35|0.27||Comparison was carried out using MMRM, with study center (pooled), TG, visit, ADT status, and TG BVI, gender BVI, age BVI as factors and baseline BVI as covariate. An unstructured covariance was used.|MMRM|||||0.27|-0.35|0.7759
71651059|NCT04100096|142819995|SUPERIORITY||LS Mean Difference|-0.06||||0.6585|TWO_SIDED|95.0|-0.32|0.2||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 2||0.20|-0.32|0.6585
71703000|NCT02347787|142923173|SUPERIORITY|||||||0.3|||||||Regression, Linear|||Determination of targeted sample size was based on detecting a between-arm difference in mean change in SF-12 Physical Component Summary of 3 points, which is the minimal clinically significant difference for this instrument. To achieve at least 80% power with a type I error rate of 5%, we required 444 total participants. To account for 25% attrition, we aimed to accrue 592 participants.||||0.30
71651060|NCT04100096|142819995|SUPERIORITY||LS Mean Difference|-0.25||||0.1181|TWO_SIDED|95.0|-0.57|0.06||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 4||0.06|-0.57|0.1181
71651061|NCT04100096|142819995|SUPERIORITY||LS Mean Difference|-0.19||||0.2431|TWO_SIDED|95.0|-0.51|0.13||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 6||0.13|-0.51|0.2431
71651062|NCT04100096|142819995|SUPERIORITY||LS Mean Difference|-0.3||||0.0638|TWO_SIDED|95.0|-0.61|0.02||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 8||0.02|-0.61|0.0638
71651063|NCT04100096|142819995|SUPERIORITY||LS Mean Difference|-0.11||||0.505|TWO_SIDED|95.0|-0.44|0.22||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 10||0.22|-0.44|0.5050
71703001|NCT02347787|142923174|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-1.3|0.9|||Regression, Linear|||||0.9|-1.3|0.21
71703002|NCT02347787|142923175|SUPERIORITY||Risk Difference (RD)|-0.2||||0.21|TWO_SIDED|95.0|-0.7|0.4|||Regression, Linear|||||0.4|-0.7|0.21
71703003|NCT02347787|142923176|SUPERIORITY||Risk Difference (RD)|-0.5||||0.21|TWO_SIDED|95.0|-2.2|1.2|||Regression, Linear|||||1.2|-2.2|0.21
71703004|NCT02347787|142923177|SUPERIORITY||Risk Difference (RD)|-6.3||||0.21|TWO_SIDED|95.0|-14.3|1.8|||Regression, Linear|||||1.8|-14.3|0.21
71651064|NCT04100096|142819995|SUPERIORITY||LS Mean Difference|-0.14||||0.4277|TWO_SIDED|95.0|-0.48|0.21||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|MMRM||Derived from an MMRM with fixed effects of treatment, (pooled) trial site, visit, ADT status (with/without background ADT), treatment BVI, gender BVI, covariates of baseline BVI and age BVI.|Week 12||0.21|-0.48|0.4277
71651065|NCT04100096|142819996|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6225|TWO_SIDED|95.0|-0.18|0.3||Comparison between TGs was carried out using the Cochran-Mantel-Haenszel (CMH) Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.30|-0.18|0.6225
71651066|NCT04100096|142819996|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9145|TWO_SIDED|95.0|-0.35|0.31||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.31|-0.35|0.9145
71651067|NCT04100096|142819996|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.1535|TWO_SIDED|95.0|-0.52|0.08||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.08|-0.52|0.1535
71651068|NCT04100096|142819996|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1922|TWO_SIDED|95.0|-0.5|0.1||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||0.10|-0.50|0.1922
71651069|NCT04100096|142819996|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.6488|TWO_SIDED|95.0|-0.4|0.25||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.25|-0.40|0.6488
71651070|NCT04100096|142819996|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.5992|TWO_SIDED|95.0|-0.4|0.23||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||0.23|-0.40|0.5992
71651071|NCT04100096|142819997|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6579|TWO_SIDED|95.0|-0.29|0.19||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 2||0.19|-0.29|0.6579
71651072|NCT04100096|142819997|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3728|TWO_SIDED|95.0|-0.43|0.16||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 4||0.16|-0.43|0.3728
71651073|NCT04100096|142819997|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1684|TWO_SIDED|95.0|-0.5|0.09||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 6||0.09|-0.50|0.1684
71651074|NCT04100096|142819997|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.0046|TWO_SIDED|95.0|-0.74|-0.13||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 8||-0.13|-0.74|0.0046
71651075|NCT04100096|142819997|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2087|TWO_SIDED|95.0|-0.51|0.11||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 10||0.11|-0.51|0.2087
71651076|NCT04100096|142819997|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0389|TWO_SIDED|95.0|-0.64|-0.02||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Cochran-Mantel-Haenszel||Comparison between TGs was carried out using the CMH Row Mean Score Differ Test controlling for trial site.|Week 12||-0.02|-0.64|0.0389
71651077|NCT04100096|142820002|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.272|TWO_SIDED|95.0|-0.14|0.5||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 2||0.50|-0.14|0.2720
71703005|NCT02347787|142923178|SUPERIORITY|||||||0.41|||||||Regression, Linear|||||||0.41
71703006|NCT02347787|142923179|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71703007|NCT02347787|142923180|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||||1.5|0.6|0.98
71703008|NCT02347787|142923182|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71703009|NCT02347787|142923183|SUPERIORITY|||||||0.02|||||||Regression, Logistic|||||||0.02
71703010|NCT02347787|142923184|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
71703011|NCT02347787|142923186|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||0.09
71703012|NCT02347787|142923187|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71703013|NCT05643794|142923193|SUPERIORITY||Difference from Placebo|-0.54||||0.129|TWO_SIDED|95.0|-1.24|0.16|||Longitudinal linear mixed effect model||The difference presented is RLZ 12 weeks minus Placebo.|||0.16|-1.24|0.129
71703014|NCT05643794|142923196|SUPERIORITY||Difference from Placebo|-0.51||||0.358|TWO_SIDED|95.0|-1.6|0.58|||Longitudinal mixed effects model||The difference presented is RLZ 24 weeks minus PBO 24 weeks.|||0.58|-1.60|0.358
71703015|NCT05643794|142923197|SUPERIORITY||Difference from Placebo|-8.4||||0.003|TWO_SIDED|95.0|-13.84|-2.96|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo|||-2.96|-13.84|0.003
71703016|NCT05643794|142923198|SUPERIORITY||Differences from Placebo|0.05||||0.878|TWO_SIDED|95.0|-0.55|0.64|||Longitudinal mixed effects model||The differences presented is RLZ 12 weeks minus Placebo.|||0.64|-0.55|0.878
71703017|NCT05643794|142923199|SUPERIORITY||Difference from Placebo|-0.28||||0.352|TWO_SIDED|95.0|-0.86|0.31|||Longitudinal mixed effects model||The difference presented is RLZ 12 weeks minus Placebo.|||0.31|-0.86|0.352
71651078|NCT04100096|142820002|SUPERIORITY||Mean Difference (Final Values)|1.09||||0|TWO_SIDED|95.0|0.63|1.56||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||1.56|0.63|0
71703018|NCT04766333|142923221|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|0.17|1.23|||Regression, Logistic||Healthcare Arm is the reference category|||1.23|0.17|<0.05
71703019|NCT00639379|142923235|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.65|Odds Ratio (OR)|0.967|||||TWO_SIDED|98.98|0.436|0.967|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.||0.967|0.436|
71703020|NCT00639379|142923236|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.65|Odds Ratio (OR)|1.416|||||TWO_SIDED|98.98|0.68|1.416|||Regression, Logistic||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.||1.416|0.680|
71703021|NCT00639379|142923237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|0.1868|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|98.98|-0.0517|0.1868|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.||0.1868|-0.0517|
71703022|NCT00639379|142923238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.4|Mean Difference (Final Values)|-0.01185|STANDARD_ERROR_OF_MEAN|0.08566|||TWO_SIDED|98.98|-0.2337|-0.01185|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.||-0.01185|-0.2337|
71703023|NCT00639379|142923239|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.01267|STANDARD_ERROR_OF_MEAN|0.01265|||TWO_SIDED|98.98|-0.01267|0.01986|||||The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.||0.01986|-0.01267|
71703024|NCT05177094|142923242|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-0.7|0.4|||||Posterior mean difference with 95% credible interval is reported.|||0.40|-0.70|
71703025|NCT05177094|142923243|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.66|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.66|
71703026|NCT05177094|142923244|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.72|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.72|
71703027|NCT05177094|142923245|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.98|0.46|||||Posterior mean difference with 95% credible interval is reported.|||0.46|-0.98|
71703028|NCT05177094|142923246|SUPERIORITY||Posterior Mean Difference|-0.22|||||TWO_SIDED|95.0|-0.61|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-0.61|
71762767|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.55|0.39|<0.0001
71762768|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.31|0.44||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.31|<0.0001
71651079|NCT04100096|142820002|SUPERIORITY||Mean Difference (Final Values)|1.18||||0|TWO_SIDED|95.0|0.63|1.73||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||1.73|0.63|0
71651080|NCT04100096|142820002|SUPERIORITY||Mean Difference (Final Values)|1.57||||0|TWO_SIDED|95.0|0.92|2.21||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||2.21|0.92|0
71651081|NCT04100096|142820002|SUPERIORITY||Mean Difference (Final Values)|1.72||||0|TWO_SIDED|95.0|0.99|2.45||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||2.45|0.99|0
71651082|NCT04100096|142820002|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.0002|TWO_SIDED|95.0|0.68|2.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||2.19|0.68|0.0002
71651083|NCT04100096|142820003|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.062|TWO_SIDED|95.0|-0.07|2.68|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 12||2.68|-0.07|0.0620
71651084|NCT04100096|142820004|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.4613|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.||Week 2||0.17|-0.08|0.4613
71651085|NCT04100096|142820004|SUPERIORITY||Mean Difference (Final Values)|0.38||||0|TWO_SIDED|95.0|0.21|0.55||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 4||0.55|0.21|0
71651086|NCT04100096|142820004|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0001|TWO_SIDED|95.0|0.21|0.61||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.61|0.21|0.0001
71651087|NCT04100096|142820004|SUPERIORITY||Mean Difference (Final Values)|0.56||||0|TWO_SIDED|95.0|0.33|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 8||0.80|0.33|0
71651088|NCT04100096|142820004|SUPERIORITY||Mean Difference (Final Values)|0.61||||0|TWO_SIDED|95.0|0.34|0.88||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 10||0.88|0.34|0
71651089|NCT04100096|142820004|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.0004|TWO_SIDED|95.0|0.23|0.8||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.80|0.23|0.0004
71651090|NCT04100096|142820006|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1687|TWO_SIDED|95.0|-0.04|0.25||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.25|-0.04|0.1687
71651091|NCT04100096|142820006|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.1874|TWO_SIDED|95.0|-0.06|0.29||Analysis of covariance (ANCOVA) model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.29|-0.06|0.1874
71651092|NCT04100096|142820007|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.0974|TWO_SIDED|95.0|-0.25|0.02||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 6||0.02|-0.25|0.0974
71651093|NCT04100096|142820007|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.391|TWO_SIDED|95.0|-0.2|0.08||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons|ANCOVA|||Week 12||0.08|-0.20|0.3910
71651094|NCT04100096|142820008|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0063|TWO_SIDED|9.0|0.04|0.26||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 6||0.26|0.04|0.0063
71651095|NCT04100096|142820008|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.067|TWO_SIDED|95.0|-0.01|0.19||ANCOVA model, with treatment as main effect and baseline value as covariate, is used for change from baseline of case comparisons.|ANCOVA|||Week 12||0.19|-0.01|0.0670
71651096|NCT01118026|142820010|SUPERIORITY|||||||0.9669|||||||Log Rank|||||||0.9669
71651097|NCT00831233|142820023|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-2.95||||0.1973|TWO_SIDED|95.0|-7.51|1.61||FAS.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.61|-7.51|0.1973
71651098|NCT00831233|142820023|NON_INFERIORITY_OR_EQUIVALENCE|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-5.88||||0.0398|TWO_SIDED|95.0|-11.5|-0.291||PP analysis set.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||-0.291|-11.5|0.0398
71651099|NCT00831233|142820024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47||||0.2298|TWO_SIDED|95.0|-6.58|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-6.58|0.2298
71651100|NCT00831233|142820024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983||||0.6917|TWO_SIDED|95.0|-5.98|4.02|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.02|-5.98|0.6917
71651101|NCT00831233|142820025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.553||||0.8151|TWO_SIDED|95.0|-5.33|4.22|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||4.22|-5.33|0.8151
71651102|NCT00831233|142820025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.455|TWO_SIDED|95.0|-2.46|5.38|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||5.38|-2.46|0.455
71651103|NCT00831233|142820025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.3186|TWO_SIDED|95.0|-2.04|6.08|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||6.08|-2.04|0.3186
71651104|NCT00831233|142820026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.5627|TWO_SIDED|95.0|-37.8|68.2|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||68.2|-37.8|0.5627
71651105|NCT00831233|142820026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91||||0.8284|TWO_SIDED|95.0|-49.1|60.9|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||60.9|-49.1|0.8284
71651106|NCT00831233|142820026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.5984|TWO_SIDED|95.0|-34.4|58.8|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||58.8|-34.4|0.5984
71651107|NCT00831233|142820027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.83||||0.1018|TWO_SIDED|95.0|-17.3|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.||1.64|-17.3|0.1018
71651108|NCT01098110|142820053|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-11.29|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-15.42|-7.16||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-7.16|-15.42|<0.0001
71703029|NCT05177094|142923247|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.58|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.58|
71703030|NCT05177094|142923248|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.68|0.45|||||Posterior mean difference with 95% credible interval is reported.|||0.45|-0.68|
71703031|NCT05177094|142923249|SUPERIORITY||Posterior Mean Difference|0.06|||||TWO_SIDED|95.0|-0.65|0.77|||||Posterior mean difference with 95% credible interval is reported.|||0.77|-0.65|
71703032|NCT05177094|142923250|SUPERIORITY||Posterior Mean Difference|-3.09|||||TWO_SIDED|95.0|-10.43|4.28|||||Posterior mean difference with 95% credible interval is reported.|||4.28|-10.43|
71824502|NCT02926937|143153103|SUPERIORITY||Percentage Difference|19.2||||0.0007|TWO_SIDED|95.0|8.39|30.0|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from each stratum (randomization strata of HbA1c (\<=8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, \>=130 mmHg) at screening) using Cochran-Mantel-Haenszel weights.||30.00|8.39|0.0007
71824503|NCT02926937|143153104|SUPERIORITY||Difference in LS Mean|-0.67|||<|0.0001|TWO_SIDED|95.0|-0.989|-0.354|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, \>8.0%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.354|-0.989|<0.0001
71824504|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 1.|Student's t-test|||||||<0.0001
71651109|NCT01098110|142820053|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.22|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-17.33|-9.12||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-9.12|-17.33|<0.0001
71651110|NCT01098110|142820054|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.47|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-4.8|-2.13|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-2.13|-4.80|<0.0001
71651111|NCT01098110|142820054|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.11|-2.46|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-2.46|-5.11|<0.0001
71703033|NCT05177094|142923251|SUPERIORITY||Posterior Mean Difference|-1.5|||||TWO_SIDED|95.0|-10.04|7.0|||||Posterior mean difference with 95% credible interval is reported.|||7.00|-10.04|
71824505|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 14.|Student's t-test|||||||<0.0001
71824506|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Day 31.|Student's t-test|||||||<0.0001
71886475|NCT00848354|143293347|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0061
71703034|NCT05177094|142923252|SUPERIORITY||Posterior Mean Difference|0.12|||||TWO_SIDED|95.0|-0.32|0.54|||||Posterior mean difference with 95% credible interval is reported.|||0.54|-0.32|
71703035|NCT05177094|142923253|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.24|0.65|||||Posterior mean difference with 95% credible interval is reported.|||0.65|-0.24|
71824507|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 10.|Student's t-test|||||||<0.0001
71703036|NCT05177094|142923254|SUPERIORITY||Posterior Mean Difference|44.36|||||TWO_SIDED|95.0|-114.73|204.0|||||Posterior mean difference with 95% credible interval is reported.|||204.00|-114.73|
71703037|NCT05177094|142923255|SUPERIORITY||Posterior Mean Difference|-98.76|||||TWO_SIDED|95.0|-231.86|34.49|||||Posterior mean difference with 95% credible interval is reported.|||34.49|-231.86|
71703038|NCT05177094|142923256|SUPERIORITY||Posterior Mean Difference|0.01|||||TWO_SIDED|95.0|-0.05|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.05|
71703039|NCT05177094|142923257|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
71703040|NCT02400736|142923258|SUPERIORITY|"Proportion of steady workers in each group was analyzed using a logistic regression model to calculate an odds ratio and 95% Confidence Interval. Adhering to the principle of intent-to-treat, participants were retained in the arm to which they were randomized for the 12-month follow-up period despite discontinuing the treatment intervention or exiting the study early. Missing data was counted as not worked."|Odds Ratio (OR)|2.49||||0.02|TWO_SIDED|95.0|1.14|5.43||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||Using SamplePower 3.0 to estimate the statistical power, the target sample size of 120 (60 per group) provided 84% power to detect a 25% or greater absolute difference between groups in the percent of participants achieving 'steady worker' status (e.g., 40% in IPS vs. 15% in control arm), at the .05 level of significance, assuming a 10% attrition.||5.43|1.14|0.02
71824508|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 18.|Student's t-test|||||||<0.0001
71824509|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 26.|Student's t-test|||||||<0.0001
71824510|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 34.|Student's t-test|||||||<0.0001
71824511|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 42.|Student's t-test|||||||<0.0001
71824512|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 50.|Student's t-test|||||||<0.0001
71824513|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 58.|Student's t-test|||||||<0.0001
71824514|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 70.|Student's t-test|||||||<0.0001
71824515|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 82.|Student's t-test|||||||<0.0001
71651112|NCT01098110|142820055|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.47|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.53|-1.41|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.41|-3.53|<0.0001
71651113|NCT01098110|142820055|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-4.08|-1.97|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.97|-4.08|<0.0001
71651114|NCT01098110|142820056|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-5.46|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-7.56|-3.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-3.35|-7.56|<0.0001
71651115|NCT01098110|142820056|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.53|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-8.62|-4.44||Statistical significant: p=\<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-4.44|-8.62|<0.0001
71703041|NCT02400736|142923259|SUPERIORITY|Intent to treat analysis.||||||0.003||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||Total mean time worked was compared using an analysis of variance (ANOVA).||||0.003
71703042|NCT02400736|142923260|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|||intent to treat analysis||||0.005
71703043|NCT02400736|142923261|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.033|||||||t-test, 2 sided|||||||0.033
71703044|NCT02400736|142923262|SUPERIORITY|||||||0.853||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||||||0.853
71703045|NCT02400736|142923263|SUPERIORITY|a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.||||||0.004|||||||t-test, 2 sided|||||||0.004
71824516|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 94.|Student's t-test|||||||<0.0001
71651116|NCT01098110|142820057|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-3.41|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.72|-2.09|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-2.09|-4.72|<0.0001
71651117|NCT01098110|142820057|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.97|-2.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.35|-4.97|<0.0001
71703046|NCT02400736|142923264|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Mixed Models Analysis|Effect of treatment on outcome was analyzed using longitudinal mixed-effects regression model.Group by time interaction tested for treatment effect.||The effect of treatment on each of secondary outcome measures were analyzed using a longitudinal mixed-effects regression model. The group by time interaction tested for the treatment effect.||||0.47
71703047|NCT02400736|142923265|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.062
71703048|NCT02400736|142923266|SUPERIORITY||||||>|0.3||||||a priori threshold for statistical significance p \</= 0.05 or lower. No adjustments were made for multiple comparisons.|ANOVA|||||||>0.3
71703049|NCT02400736|142923267|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.001
71703050|NCT02400736|142923268|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance p \</=0.05; not adjusted for multiple comparisons.|Chi-squared|||||||0.006
71703051|NCT02383173|142923271|OTHER|||||||0.445|||||||Generalized Estimating Equation (GEE)|Sandwich estimators were used to adjust for the small number of clusters.||Generalized Estimating Equation (GEE) analyses of post-intervention data were used to account for clustering. We adjusted for age, race, cancer, length of stay and study year.||||0.445
71703052|NCT03677401|142923286|SUPERIORITY|P-value from a Cochran-Mantel- Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.158|||||||Cochran-Mantel-Haenszel|||At Week 10||||0.158
71651118|NCT01098110|142820058|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.36|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.47|-1.26|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID|||-1.26|-3.47|<0.0001
71703053|NCT03677401|142923287|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.||||||0.75|||||||Cochran-Mantel-Haenszel|||At Week 4||||0.750
71703054|NCT03677401|142923288|SUPERIORITY|P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation||||||0.674|||||||Cochran-Mantel-Haenszel|||At Week 2||||0.674
71703055|NCT03677401|142923289|SUPERIORITY|P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.06|||||||ANCOVA|||At Week 2||||0.060
71703056|NCT03677401|142923289|SUPERIORITY|||||||0.401||||||P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.401
71703057|NCT03677401|142923289|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.185|||||||ANCOVA|||At Week 6||||0.185
71824517|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 106.|Student's t-test|||||||<0.0001
71824518|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 118.|Student's t-test|||||||<0.0001
71824519|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 130.|Student's t-test|||||||<0.0001
71824520|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 142.|Student's t-test|||||||<0.0001
71824521|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 154.|Student's t-test|||||||<0.0001
71824522|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 166.|Student's t-test|||||||<0.0001
71824523|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 178.|Student's t-test|||||||<0.0001
71824524|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 190.|Student's t-test|||||||<0.0001
71824525|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 202.|Student's t-test|||||||<0.0001
71651119|NCT01098110|142820058|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-4.03|-1.84|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID|||-1.84|-4.03|<0.0001
71651120|NCT01098110|142820059|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-3.73|-1.7|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-1.70|-3.73|<0.0001
71651121|NCT01098110|142820059|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.08|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.09|-2.08|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-2.08|-4.09|<0.0001
71651122|NCT01098110|142820060|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.62|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.41|-0.83|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.83|-2.41|<0.0001
71651123|NCT01098110|142820060|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.26|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.04|-1.47|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-1.47|-3.04|<0.0001
71651124|NCT01098110|142820061|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-1.41|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.04|-0.78|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.78|-2.04|<0.0001
71651125|NCT01098110|142820061|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.16|-0.91|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.91|-2.16|<0.0001
71703058|NCT03677401|142923289|SUPERIORITY|P-values, LS Mean and LS SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.||||||0.164|||||||ANCOVA|||At Week 10||||0.164
71703059|NCT03677401|142923290|SUPERIORITY|||||||0.283||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.283
71703060|NCT03677401|142923290|SUPERIORITY|||||||0.701||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.701
71824526|NCT02449044|143153251|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||This was the p-value for analysis at Week 214.|Student's t-test|||||||<0.0001
71824527|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.4922
71824528|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.1054
71651126|NCT01098110|142820062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.6||||0.0001|TWO_SIDED|95.0|9.2|28.1||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||28.1|9.2|0.0001
71824529|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.7656|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.7656
71651127|NCT01098110|142820062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||<|0.0001|TWO_SIDED|95.0|13.7|32.6||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||32.6|13.7|<0.0001
71703061|NCT03677401|142923290|SUPERIORITY|||||||0.033||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.033
71703062|NCT03677401|142923291|SUPERIORITY|||||||0.797||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.797
71824530|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.7084|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.7084
71824531|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.5138
71824532|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.7175|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.7175
71824533|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.3540
71824534|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.0852|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0852
71824535|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.1923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.1923
71824536|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.2335|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2335
71824537|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.1346|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.1346
71824538|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.5237|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.5237
71824539|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.3476|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 118||||0.3476
71824540|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.2488|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 130||||0.2488
71824541|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.1598|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.1598
71824542|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.282|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 154||||0.2820
71824543|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.3743|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.3743
71824544|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.3600
71824545|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.3101|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3101
71824546|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 202||||0.0269
71824547|NCT02449044|143153258|SUPERIORITY_OR_OTHER|||||||0.0944|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.0944
71824548|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.1739
71824549|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.6095|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.6095
71824550|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.6902|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6902
71824551|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.634|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.6340
71824552|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.321|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.3210
71651128|NCT01098110|142820063|SUPERIORITY_OR_OTHER_LEGACY||Least square (LS) means difference|-0.52|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID|||-0.28|-0.75|<0.0001
71651129|NCT01098110|142820063|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.82|-0.36|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID|||-0.36|-0.82|<0.0001
71651130|NCT01098110|142820064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.2|||<|0.0001|TWO_SIDED|95.0|12.0|32.4||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID|||32.4|12.0|<0.0001
71824553|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.7787|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.7787
71824554|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.2198|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.2198
71824555|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.1926|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.1926
71824556|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.3109|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.3109
71824557|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.2269
71824558|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.2749
71824559|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.0702|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0702
71824560|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0412
71824561|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.4448|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.4448
71824562|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.6233|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6233
71651131|NCT01098110|142820064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.8|||<|0.0001|TWO_SIDED|95.0|18.9|38.8||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID|||38.8|18.9|<0.0001
71651132|NCT02147587|142820066|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.213|||||TWO_SIDED|80.0|1.033|1.424|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 4|Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)||1.424|1.033|
71651133|NCT02147587|142820067|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.03|||||TWO_SIDED|80.0|0.877|1.209|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Day 1|GMFR for Tofacitinib versus Placebo (Day 1)||1.209|0.877|
71651134|NCT02147587|142820067|SUPERIORITY_OR_OTHER||Ratio of GMFR|1.093|||||TWO_SIDED|80.0|0.924|1.294|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMFRs are adjusted for baseline factors. GMFRs and 80% CIs are back-transformed from log scale.|Ratio of GMFRs (Tofacitinib/Placebo) at Week 12|GMFR for Tofacitinib versus Placebo (Week 12)||1.294|0.924|
71651135|NCT02147587|142820068|SUPERIORITY_OR_OTHER||Ratio of GMT|1.063|||||TWO_SIDED|80.0|0.821|1.375|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Day 1|Geometric Mean Titer (GMT) for Tofacitinib versus Placebo (Day 1)||1.375|0.821|
71762769|NCT04518995|143027157|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.39|0.55||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.55|0.39|<0.0001
71762770|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0816|TWO_SIDED|95.0|0.0|0.02||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.02|-0.00|0.0816
71762771|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.0005|TWO_SIDED|95.0|0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|0.01|0.0005
71762772|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.016||0.0002|TWO_SIDED|95.0|0.03|0.09||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.09|0.03|0.0002
71762773|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
71762774|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.22|0.12|<0.0001
71762775|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.14|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.19||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.19|0.10|<0.0001
71762776|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.2|0.33||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.33|0.20|<0.0001
71762777|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.19|0.28||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.28|0.19|<0.0001
71762778|NCT04518995|143027158|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.28|0.41||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.41|0.28|<0.0001
71762779|NCT04518995|143027159|SUPERIORITY||Least Square (LS) Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.13||0.0564|TWO_SIDED|95.0|-4.4|0.1||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||0.1|-4.4|0.0564
71762780|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.23||0.0054|TWO_SIDED|95.0|-5.9|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.0|-5.9|0.0054
71762781|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED|95.0|-12.7|-4.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-4.3|-12.7|<0.0001
71762782|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.34|<|0.0001|TWO_SIDED|95.0|-19.5|-10.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-10.3|-19.5|<0.0001
71762783|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-21.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-27.5|-16.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-16.0|-27.5|<0.0001
71762784|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-36.3|-23.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-23.8|-36.3|<0.0001
71762785|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|3.38|<|0.0001|TWO_SIDED|95.0|-35.1|-21.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-21.8|-35.1|<0.0001
71762786|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.7|-31.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-31.3|-45.7|<0.0001
71762787|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-34.9|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-27.7|-42.1|<0.0001
71703063|NCT03677401|142923292|SUPERIORITY|||||||0.845||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.845
71703064|NCT03677401|142923293|SUPERIORITY|||||||0.385||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.385
71703065|NCT03677401|142923293|SUPERIORITY|||||||0.786||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.786
71703066|NCT03677401|142923293|SUPERIORITY|||||||0.502||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.502
71703067|NCT03677401|142923294|SUPERIORITY|||||||0.197||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.197
71703068|NCT03677401|142923294|SUPERIORITY|||||||0.694||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.694
71703069|NCT03677401|142923294|SUPERIORITY|||||||0.916||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.916
71703070|NCT02421211|142923296|SUPERIORITY_OR_OTHER||LS means ratio|4.7|||||TWO_SIDED|90.0|3.4|6.5||||||||6.5|3.4|
71824563|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.1001|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.1001
71824564|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.3739|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.3739
71824565|NCT02449044|143153259|SUPERIORITY_OR_OTHER|||||||0.3334|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3334
71824566|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.2575|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14||||0.2575
71703071|NCT02421211|142923297|SUPERIORITY_OR_OTHER||LS means ratio|2.3|||||TWO_SIDED|90.0|2.0|2.8||||||||2.8|2.0|
71703072|NCT02421211|142923298|SUPERIORITY_OR_OTHER||LS means ratio|3.1|||||TWO_SIDED|90.0|2.4|3.8||||||||3.8|2.4|
71703073|NCT02421211|142923299|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.5|2.0||||||||2.0|1.5|
71824567|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.2715|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31||||0.2715
71824568|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.686|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10||||0.6860
71651136|NCT02147587|142820068|SUPERIORITY_OR_OTHER||Ratio of GMT|1.251|||||TWO_SIDED|80.0|0.967|1.618|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 4|GMT for Tofacitinib versus Placebo (Week 4)||1.618|0.967|
71824569|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0224|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18||||0.0224
71824570|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.1871|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26||||0.1871
71824571|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34||||0.0039
71824572|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0325|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42||||0.0325
71651137|NCT02147587|142820068|SUPERIORITY_OR_OTHER||Ratio of GMT|1.121|||||TWO_SIDED|80.0|0.862|1.459|||ANCOVA|Repeated-measures ANCOVA model for the log-transformed GMTs are adjusted for baseline factors. GMTs and 80% CIs are back-transformed from log scale.|Ratio of GMTs (Tofacitinib/Placebo) at Week 12|GMT for Tofacitinib versus Placebo (Week 12)||1.459|0.862|
71651138|NCT02147587|142820069|SUPERIORITY_OR_OTHER||Difference in percentages|8.39|||||TWO_SIDED|80.0|-4.05|20.56|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Day 1)||20.56|-4.05|
71651139|NCT02147587|142820069|SUPERIORITY_OR_OTHER||Difference in percentages|14.01|||||TWO_SIDED|80.0|1.57|26.03|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 4)||26.03|1.57|
71651140|NCT02147587|142820069|SUPERIORITY_OR_OTHER||Difference in percentages|2.65|||||TWO_SIDED|80.0|-10.66|15.83|||80% CI based on Chan and Zhang method|||Tofacitinib versus Placebo (Week 12)||15.83|-10.66|
71703074|NCT02421211|142923300|SUPERIORITY_OR_OTHER||LS means ratio|1.6|||||TWO_SIDED|90.0|1.4|1.9||||||||1.9|1.4|
71703075|NCT02421211|142923301|SUPERIORITY_OR_OTHER||LS means ratio|1.7|||||TWO_SIDED|90.0|1.6|2.0||||||||2.0|1.6|
71703076|NCT01177410|142923316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.369||||0.0432|TWO_SIDED|95.0|1.027|5.467|||Regression, Logistic|||||5.467|1.027|0.0432
71703077|NCT01177410|142923316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.267||||0.6059|TWO_SIDED|95.0|0.515|3.115|||Regression, Logistic|||||3.115|0.515|0.6059
71703078|NCT01177410|142923317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.232||||0.0327|TWO_SIDED|95.0|1.068|4.664|||Proportional Odds Model|||Proportional odds model was used to compare the number of months the subjects are responders.||4.664|1.068|0.0327
71703079|NCT01177410|142923317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.148||||0.726|TWO_SIDED|95.0|0.531|2.483|||Proportional Odds Model|||||2.483|0.531|0.7260
71703080|NCT00924482|142923324|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient (R^2)|0.63||||||95.0|||||Regression, Linear|Linear regression between the average of six thermodilution cardiac output measurements was compared to the average of six ECOM output measurements||||||
71739296|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.969|||||TWO_SIDED|95.0|0.392|2.398||||||Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.398|0.392|
71703081|NCT00875667|142923336|SUPERIORITY||Stratified Hazard Ratio|0.63||||0.012|TWO_SIDED|95.0|0.43|0.9||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test|||||0.90|0.43|0.012
71824573|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50||||0.0631
71824574|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0277|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58||||0.0277
71651141|NCT01028911|142820103|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|128.4|||||TWO_SIDED|90.0|75.9|217.21||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||217.21|75.90|
71651142|NCT01028911|142820104|SUPERIORITY_OR_OTHER||Adjusted Geometric Means Ratio|119.82|||||TWO_SIDED|90.0|75.9|189.16||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.||189.16|75.90|
71651143|NCT00530348|142820111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.2173|TWO_SIDED|95.0|0.4|1.23||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.||1.23|0.40|0.2173
71651144|NCT00530348|142820112|SUPERIORITY_OR_OTHER||Rate ratio|0.45|||<|0.0001|TWO_SIDED|95.0|0.32|0.63||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.63|0.32|<0.0001
71651145|NCT00530348|142820113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.33|0.61|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||0.61|0.33|<0.0001
71651146|NCT00530348|142820114|SUPERIORITY_OR_OTHER|||||||0.4188|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.4188
71651147|NCT00530348|142820115|SUPERIORITY_OR_OTHER|||||||0.0115|||||||Wei-Lachin|||Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.||||0.0115
71651148|NCT00530348|142820116|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.||||0.3080
71651149|NCT02020967|142820175|OTHER||Odds Ratio (OR)|7.34||||0.0196|TWO_SIDED|95.0|1.38|39.11|||Regression, Logistic|||Predictor variable: Lips enlargement||39.11|1.38|0.0196
71651150|NCT02630316|142820218|SUPERIORITY||Hodges-Lehmann|21.0||||0.0043|TWO_SIDED|95.0|7.0|37.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||37.0|7.0|0.0043
71651151|NCT02630316|142820219|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71651152|NCT02630316|142820220|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.041|TWO_SIDED|95.0|0.4|0.92||p-value is calculated with log-rank test stratified by baseline 6MWD category.|Log Rank||p-value was 0.0202 for the proportional hazard model. Hazard ratio, 95% confidence interval (CI), and p-values are calculated with proportional hazards model with treatment and Baseline 6MWD (continuous) as explanatory variables.|||0.92|0.40|0.0410
71651153|NCT02630316|142820221|SUPERIORITY||Hodges-Lehmann|20.0||||0.0041|TWO_SIDED|95.0|7.0|34.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category|ANCOVA|||||34.0|7.0|0.0041
71651154|NCT02630316|142820222|SUPERIORITY||Hodges-Lehmann|15.0||||0.0432|TWO_SIDED|95.0|0.0|29.0||p-value is obtained from nonparametric ANCOVA adjusted for Baseline 6MWD category.|ANCOVA|||||29.0|0.0|0.0432
71703082|NCT00875667|142923337|SUPERIORITY||Stratified Hazard Ratio|0.6||||0.003|TWO_SIDED|95.0|0.43|0.85||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||The weights are based on observed events at the time the third DMC meeting was held and based on the difference between observed and expected events at the time of the primary analysis.|||0.85|0.43|0.003
71824575|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0128|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70||||0.0128
71824576|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82||||0.0164
71824577|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94||||0.0119
71824578|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106||||0.0013
71824579|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.6691|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142||||0.6691
71824580|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.6923|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166||||0.6923
71824581|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.9292|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178||||0.9292
71824582|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.4401|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190||||0.4401
71824583|NCT02449044|143153260|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214||||0.3609
71824584|NCT02624778|143153267|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.07||0.309|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||||0.07|-0.21|0.309
71824585|NCT02624778|143153267|SUPERIORITY||LS Mean|-0.133|STANDARD_ERROR_OF_MEAN|0.07||0.061|TWO_SIDED|95.0|-0.27|0.01|||Mixed Models Analysis|||||0.01|-0.27|0.061
71824586|NCT02624778|143153267|SUPERIORITY||LS Mean|-0.205|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.41|0.0|||Mixed Models Analysis|||||0.00|-0.41|0.053
71824587|NCT02624778|143153267|SUPERIORITY||LS Mean|-0.255|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||||-0.13|-0.38|<0.001
71651155|NCT02508116|142820223|SUPERIORITY||Odds Ratio (OR)|1.6||||0.03|TWO_SIDED|95.0|1.07|2.42|||Regression, Logistic|||The sample size calculation was based on two factors: 1) the rate of pre-study prasugrel/ticagrelor use (\~20%) and 2) anticipated increase in prasugrel/ticagrelor prescribing based on the frequency CYP2C19 LOF variants (\~30-35%). We estimated a 15% difference in the use of prasugrel/ticagrelor in the two groups (35% in the genotyped group and 20% in the control group). A sample size of 138 per group (a total of 276) would provide 80% power at an alpha level of 0.05 to detect this difference.||2.42|1.07|0.03
71651156|NCT02508116|142820225|SUPERIORITY|||||||0.27|||||||Log Rank|||The incidence of first MACE between the groups were compared by use of Kaplan-Meier estimators; statistical tests were based on log-rank tests.||||0.27
71824588|NCT02624778|143153267|SUPERIORITY||LS Mean|-0.369|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.23|||Mixed Models Analysis|||||-0.23|-0.51|<0.001
71651157|NCT00559364|142820231|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) model using treatment group and pooled site as fixed effects and wash-out phase CFA% value as covariate was used.||||<0.0001
71651158|NCT02578745|142820234|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
71651159|NCT02578745|142820235|SUPERIORITY||Risk Ratio (RR)|1.67||||0.72|TWO_SIDED|95.0|0.42|6.67|||Chi-squared|||||6.67|.42|0.72
71651160|NCT02578745|142820236|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71651161|NCT02578745|142820237|SUPERIORITY||||||>|0.99|TWO_SIDED|95.0|||||Chi-squared|||||||>0.99
71824589|NCT02624778|143153267|SUPERIORITY||LS Mean|-0.329|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.20|-0.46|<0.001
71824590|NCT05541497|143153274|SUPERIORITY||Risk Ratio (RR)|1.51|||||TWO_SIDED|95.0|0.68|3.37||||||||3.37|0.68|
71824591|NCT05541497|143153275|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.59|3.13||||||||3.13|0.59|
71824592|NCT00587288|143153281|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.194||0.0541|TWO_SIDED|95.0|-0.76|0.01||The p-value for the treatment comparison is based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.01|-0.76|0.0541
71824593|NCT00587288|143153282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0848|TWO_SIDED|95.0|0.91|4.46||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||4.46|0.91|0.0848
71824594|NCT00587288|143153283|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0023|TWO_SIDED|95.0|0.088|0.392||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||0.392|0.088|0.0023
71824595|NCT00587288|143153284|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.98|STANDARD_ERROR_OF_MEAN|2.36||0.001|TWO_SIDED|95.0|3.3|12.65||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA|||||12.65|3.30|0.0010
71824596|NCT00587288|143153285|SUPERIORITY_OR_OTHER||Adjusted mean difference|-125.29|STANDARD_ERROR_OF_MEAN|44.885||0.0068|TWO_SIDED|95.0|-214.81|-35.77||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline. The difference between reslizumab 3.0 mg/kg and placebo groups was from comparison of the least square means.|ANCOVA|||||-35.77|-214.81|0.0068
71824597|NCT00587288|143153286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.0833|TWO_SIDED|95.0|0.1|1.15||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic|||||1.15|0.10|0.0833
71824598|NCT00587288|143153286|SUPERIORITY_OR_OTHER|||||||0.0809|||||||Log Rank|The p value for the treatment comparison was based on log rank test adjusting for stratification factor (ie, ACQ score ≤2 and \>2).||"Kaplan-Meier estimate of time to first CAE. (First quartile, median and third quartile survival times with 95% confidence intervals (ie, time to first CAE) could not be estimated since the proportion of patients experiencing CAE was too low. Therefore, the only number presented in regard to the Kaplan-Meier analysis is the p-value of the log-rank test, below. )"||||0.0809
71886476|NCT00848354|143293347|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0730
71824599|NCT00531479|143153288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74||||0.0434|TWO_SIDED|95.0|-18.99|1.51||P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||The 95% CI was based on using Greenwood's formula for the variance of the KM estimator.|All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.||1.51|-18.99|0.0434
71824600|NCT00531479|143153289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.23|||||TWO_SIDED|95.0|-21.6|1.15||P-value for global response was to be reported only if Week 6 mortality was significant.|||95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.15|-21.6|
71824601|NCT00531479|143153290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2611|TWO_SIDED|95.0|-10.77|5.56||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||5.56|-10.77|0.2611
71824602|NCT00531479|143153291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.18||||0.0383|TWO_SIDED|95.0|-21.44|1.09||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence intervalbased on using Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||1.09|-21.44|0.0383
71824603|NCT00531479|143153292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.1029|TWO_SIDED|95.0|-15.9|3.42||P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on Greenwood's formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.||3.42|-15.9|0.1029
71824604|NCT00531479|143153293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.083|TWO_SIDED|95.0|0.46|1.04|||Cox proportional hazards model|||Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.||1.04|0.46|0.083
71824605|NCT00531479|143153294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.164|TWO_SIDED|95.0|0.4|1.16|||Cox proportional hazards model||95% confidence interval based on Greenwood's formula.|Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.||1.16|0.40|0.164
71824606|NCT00672256|143153350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
71824607|NCT00672256|143153351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
71824608|NCT00672256|143153352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
71651162|NCT02578745|142820238|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71651163|NCT02578745|142820239|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.50
71651164|NCT00330460|142820240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.22%.|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.7|1.2|||ANCOVA|||||1.2|0.7|<0.0001
71703083|NCT00875667|142923338|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71824609|NCT00672256|143153353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.05
71824610|NCT02072226|143153366|OTHER|Confidence Interval|Adjusted Risk Difference|-1.1|||||TWO_SIDED|95.0|-9.44|7.25||||||||7.25|-9.44|
71824611|NCT02072226|143153367|OTHER|Confidence Interval|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.527|1.244||||||||1.244|0.527|
71651165|NCT00330460|142820241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -2.29%.|Mean Difference (Final Values)|1.1|||<|0.0001||95.0|0.7|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.7|<0.0001
71651166|NCT00330460|142820242|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.65%|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.6|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1.4|0.6|<0.0001
71651167|NCT00330460|142820243|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -1.04%|Mean Difference (Final Values)|0.6|||<|0.0001||95.0|0.3|1.0||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||1|0.3|<0.0001
71824612|NCT02072226|143153368|OTHER|Confidence Interval|Odds Ratio (OR)|0.858|||||TWO_SIDED|95.0|0.529|1.393||||||||1.393|0.529|
71824613|NCT02072226|143153369|OTHER|Confidence Interval|difference in percentages|3.25|||||TWO_SIDED|95.0|0.75|7.38||||||||7.38|0.75|
71824614|NCT02072226|143153370|OTHER|Confidence Interval|difference in percentages|4.53|||||TWO_SIDED|95.0|-0.34|10.07||||||Any ICH within 36 hours reported by site||10.07|-0.34|
71703084|NCT00875667|142923339|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703085|NCT00875667|142923340|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.421|TWO_SIDED|95.0|0.29|1.68|||Log Rank|||||1.68|0.29|0.421
71703086|NCT00875667|142923341|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.875|TWO_SIDED|95.0|0.52|1.74|||Log Rank|||||1.74|0.52|0.875
71703087|NCT00875667|142923342|SUPERIORITY|||||||0.313|||||||Chi-squared|||||||0.313
71824615|NCT02072226|143153370|OTHER|Confidence Interval|difference in percentages|3.87|||||TWO_SIDED|95.0|-1.23|9.49||||||Any ICH within 36 hours reported by central reader||9.49|-1.23|
71824616|NCT00810303|143153381|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824617|NCT00810303|143153382|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824618|NCT00810303|143153384|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
71824619|NCT00810303|143153385|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
71824620|NCT00810303|143153386|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
71824621|NCT00810303|143153386|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.||||<0.05
71824622|NCT00810303|143153387|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
71824623|NCT00810303|143153388|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
71824624|NCT00810303|143153389|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.||||<0.05
71703088|NCT00875667|142923343|SUPERIORITY|||||||0.465|||||||Chi-squared|||||||0.465
71703089|NCT00875667|142923344|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.005|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.005
71703090|NCT00875667|142923345|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.003|TWO_SIDED|95.0|0.46|0.86|||Log Rank|||||0.86|0.46|0.003
71703091|NCT00875667|142923346|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.046|TWO_SIDED|95.0|0.54|1.0|||Log Rank|||||1.00|0.54|0.046
71824625|NCT00810303|143153389|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.||||<0.05
71824626|NCT00810303|143153390|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824627|NCT00810303|143153390|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
71824628|NCT00810303|143153391|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824629|NCT00810303|143153391|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824630|NCT00810303|143153392|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
71824631|NCT00810303|143153392|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824632|NCT00810303|143153393|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
71651168|NCT00330460|142820244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0001||95.0|0.3|0.9||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA|||||0.9|0.3|0.0001
71651169|NCT02663882|142820247|SUPERIORITY|||||||0.503||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.503
71651170|NCT02663882|142820248|SUPERIORITY|||||||0.765||||||the a priori threshold for statistical significance was p\<0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.765
71651171|NCT02663882|142820249|SUPERIORITY|||||||0.717||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.717
71651172|NCT02663882|142820250|SUPERIORITY|||||||0.302||||||the a priori threshold for statistical significance was p=0.05|ANOVA|||The non-smoking-related self control task was the comparison group in relation to the smoking-related self control task||||0.302
71651173|NCT02013531|142820273|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71651174|NCT02013531|142820274|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 6.||||<0.0001
71824633|NCT00810303|143153394|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71703092|NCT00875667|142923347|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.095|TWO_SIDED|95.0|0.58|1.05|||Log Rank|||||1.05|0.58|0.095
71703093|NCT00875667|142923348|SUPERIORITY||Hazard Ratio (HR)|3.91|||<|0.001|TWO_SIDED|95.0|1.95|7.85|||Log Rank|||||7.85|1.95|<0.001
71703094|NCT00875667|142923349|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.004|TWO_SIDED|95.0|1.24|3.42|||Log Rank|||||3.42|1.24|<0.004
71703095|NCT00875667|142923350|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.519|TWO_SIDED|95.0|0.62|1.28|||Log Rank|||||1.28|0.62|0.519
71703096|NCT00875667|142923351|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.558|TWO_SIDED|95.0|0.67|1.25|||Log Rank|||||1.25|0.67|0.558
71703097|NCT00412451|142923386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.001||||0.131|TWO_SIDED|95.0|0.001|999.999|||Fisher Exact|||||999.999|0.001|0.131
71703098|NCT00412451|142923386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.562||||0.67|TWO_SIDED|95.0|0.132|2.4|||Fisher Exact|||||2.400|0.132|0.670
71824634|NCT00810303|143153395|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.||||<0.05
71824635|NCT00810303|143153395|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.||||<0.05
71824636|NCT01124162|143153397|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|108.14|||||TWO_SIDED|90.0|97.43|120.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.03|97.43|
71824637|NCT01124162|143153398|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.7|||||TWO_SIDED|90.0|98.57|104.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.93|98.57|
71703099|NCT00412451|142923386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.346||||0.372||95.0|0.07|1.703|||Fisher Exact|||||1.703|0.070|0.372
71703100|NCT01692756|142923435|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||0.33
71703101|NCT01692756|142923436|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71703102|NCT01692756|142923437|SUPERIORITY|||||||0.93|||||||Kruskal-Wallis|||||||0.93
71703103|NCT01692756|142923438|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
71703104|NCT01692756|142923439|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
71703105|NCT01692756|142923440|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||.003
71703106|NCT01692756|142923441|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||.007
71703107|NCT01692756|142923442|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|||||||.63
71703108|NCT01692756|142923443|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
71703109|NCT01692756|142923444|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
71703110|NCT01692756|142923445|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||.02
71703111|NCT01692756|142923446|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||.20
71703112|NCT01692756|142923447|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
71703113|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-8.64|STANDARD_ERROR_OF_MEAN|2.232||0.0005|TWO_SIDED|90.0|-12.33|-4.95||Hochberg adjusted p-value|Mixed Models Analysis|||||-4.95|-12.33|0.0005
71703114|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|2.206||0.0963|TWO_SIDED|90.0|-6.99|0.3||Hochberg adjusted p-value|Mixed Models Analysis|||||0.30|-6.99|0.0963
71703115|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-7.07|STANDARD_ERROR_OF_MEAN|2.233||0.0046|TWO_SIDED|90.0|-10.76|-3.37||Hochberg adjusted p-value|Mixed Models Analysis|||||-3.37|-10.76|0.0046
71703116|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.238||0.0963|TWO_SIDED|90.0|-6.63|0.77||Hochberg adjusted p-value|Mixed Models Analysis|||||0.77|-6.63|0.0963
71703117|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-10.07|STANDARD_ERROR_OF_MEAN|2.152|<|0.0001|TWO_SIDED|90.0|-13.63|-6.51||Hochberg adjusted p-value|Mixed Models Analysis|||||-6.51|-13.63|<0.0001
71703118|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|2.255||0.0158|TWO_SIDED|90.0|-9.79|-2.33||Hochberg adjusted p-value|Mixed Models Analysis|||||-2.33|-9.79|0.0158
71703119|NCT02969018|142923448|OTHER||Least Squares Mean Difference|-4.66|STANDARD_ERROR_OF_MEAN|2.163||0.0488|TWO_SIDED|90.0|-8.24|-1.09||Hochberg adjusted p-value|Mixed Models Analysis|||||-1.09|-8.24|0.0488
71703120|NCT02969018|142923449|OTHER||Odds Ratio (OR)|10.0|||||TWO_SIDED|90.0|2.95|33.87|||||||Logistic regression|33.87|2.95|
71703121|NCT02969018|142923449|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|90.0|0.61|7.36|||||||Logistic regression|7.36|0.61|
71703122|NCT02969018|142923449|OTHER||Odds Ratio (OR)|9.09|||||TWO_SIDED|90.0|2.71|30.48|||||||Logistic regression|30.48|2.71|
71703123|NCT02969018|142923449|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
71824638|NCT01124162|143153399|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.5|||||TWO_SIDED|90.0|98.41|104.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.68|98.41|
71824639|NCT01124162|143153400|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.08|||||TWO_SIDED|90.0|98.24|106.06|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.06|98.24|
71824640|NCT01124162|143153401|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.31|||||TWO_SIDED|90.0|97.84|102.84|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.84|97.84|
71824641|NCT01124162|143153402|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.25|||||TWO_SIDED|90.0|97.87|102.69|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.69|97.87|
71824642|NCT02680756|143153403|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.298|TWO_SIDED|95.0|-0.28|-0.06|||t-test, 2 sided|||||-0.06|-0.28|0.298
71824643|NCT02680756|143153404|NON_INFERIORITY|A 2-sided CI for difference in the proportions of Hb responders (risk difference for ferric maltol - IV iron) between the two treatment groups, and comparing the LCL of this CI to the pre-specified non-inferiority margin of 20%. The CI was calculated using the Delta Method approach based on a logistic regression model, adjusted for treatment group, baseline Hb (below the observed median or at least the observed median), and IBD subgroup (UC or CD).|Risk Difference (RD)|-0.17||||0.341|TWO_SIDED|95.0|-0.3|-0.05|||t-test, 2 sided|||||-0.05|-0.30|0.341
71824644|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0|||||Mixed Models Analysis|||||||0.012
71824645|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.52
71824646|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
71824647|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.29
71824648|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
71824649|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.093
71824650|NCT00938340|143153435|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.12
71824651|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71824652|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.15
71824653|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.35
71651175|NCT02013531|142820280|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71651176|NCT03396874|142820296|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|87.3|||<|1e-07|TWO_SIDED|95.0|81.58|100.0||The exact p-value cannot be entered as it is equal to 2.2e-16.|Exact binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||We determined the positive predictive value (PPV) (true positives / (true positives + false positives)) of 68Ga-PSMA-11 PET for presence or absence of prostate cancer confirmed by histopathology on a per-patient basis. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|81.58|<0.0000001
71703124|NCT02969018|142923449|OTHER||Odds Ratio (OR)|41.67|||||TWO_SIDED|90.0|10.8|160.68|||||||Logistic regression|160.68|10.80|
71703125|NCT02969018|142923449|OTHER||Odds Ratio (OR)|2.11|||||TWO_SIDED|90.0|0.59|7.55|||||||Logistic regression|7.55|0.59|
71703126|NCT02969018|142923449|OTHER||Odds Ratio (OR)|3.86|||||TWO_SIDED|90.0|1.17|12.74|||||||Logistic regression|12.74|1.17|
71703127|NCT02969018|142923450|OTHER||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|90.0|-11.43|-6.57|||Mixed Models Analysis|||||-6.57|-11.43|<0.0001
71824654|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.011
71824655|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
71824656|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0002
71824657|NCT00938340|143153436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0013
71824658|NCT00938340|143153437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||Main effect of treatment by timepoint|Mixed Models Analysis|||||||0.15
71824659|NCT00938340|143153438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
71824660|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
71824661|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.98
71651177|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|92.3|||<|1e-07|TWO_SIDED|95.0|90.0|100.0||Per patient basis p-value = 2.2e-16|binomial proportion test|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)||PPV, composite standard, per-patient basis: We determined the positive predictive value (PPV) of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available. On a per-patient basis, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100|90.0|<0.0000001
71651178|NCT03396874|142820297|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|95.29|||<|1e-07|TWO_SIDED|95.0|93.3|100.0||Per patient basis p-value = 2.2e-16|Sensitivity|||Sensitivity, composite standard, per-patient basis: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). On a per-patient basis, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.3|<0.0000001
71651179|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.1|||<|1e-07|TWO_SIDED|95.0|86.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, prostate or prostate bed: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|86.2|<0.0000001
71651180|NCT03396874|142820297|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|91.72|||<|1e-07|TWO_SIDED|95.0|86.74|100.0||p-value = 2.2e-16 Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Exact binomial proportion test|||Sensitivity, composite standard, prostate/prostate bed: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In the prostate or prostate bed, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.74|<0.0000001
71651181|NCT03396874|142820297|OTHER|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|90.78|||<|1e-07|TWO_SIDED|95.0|85.74|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, pelvic lymph nodes: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In the prostate or prostate bed, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|85.74|<0.0000001
71651182|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|96.97|||<|1e-07|TWO_SIDED|95.0|93.2|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, pelvic lymph nodes: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In pelvic lymph nodes, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|93.20|<0.0000001
71651183|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|91.25|||<|1e-07|TWO_SIDED|95.0|84.19|100.0||p-value = 2.9e-15|Exact binomial proportion test|||PPV, composite standard, soft tissues: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In soft tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|84.19|<0.0000001
71651184|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|93.59|||<|1e-07|TWO_SIDED|95.0|86.99|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, soft tissues: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In soft tissues, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|86.99|<0.0000001
71651185|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|PPV|95.17|||<|1e-07|TWO_SIDED|95.0|91.12|100.0||p-value = 2.2e-16|Exact binomial proportion test|||PPV, composite standard, bone: PPV of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy where available (composite standard of truth). In bone tissues, the PPV of conventional imaging ranges between 30-50%. The null hypothesis is that the PPV at 50% will be tested against the alternative hypothesis that the PPV is greater than 50%.||100.00|91.12|<0.0000001
71703128|NCT02969018|142923450|OTHER||Least Squares Mean Difference|-7.99|STANDARD_ERROR_OF_MEAN|1.502|<|0.0001|TWO_SIDED|90.0|-10.48|-5.51|||Mixed Models Analysis|||||-5.51|-10.48|<0.0001
71703129|NCT04018001|142923468|SUPERIORITY|||||||0.0115|||||||Chi-squared|||||||0.0115
71703130|NCT04018001|142923468|SUPERIORITY||Odds Ratio (OR)|1.410198||||0.0227|TWO_SIDED|95.0|1.0492535|1.8953079||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.8953079|1.0492535|0.0227
71703131|NCT04018001|142923469|SUPERIORITY|||||||0.3564|||||||t-test, 2 sided|||||||0.3564
71824662|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
71651186|NCT03396874|142820297|SUPERIORITY|Exact binomial proportion test, R statistical software package: R version 4.3.1 (2023-06-16)|Sensitivity|100.0|||<|1e-07|TWO_SIDED|95.0|97.85|100.0||p-value = 2.2e-16|Exact binomial proportion test|||Sensitivity, composite standard, bone: We determined the sensitivity of 68Ga-PSMA-11 PET for presence of prostate cancer confirmed by conventional imaging, clinical follow-up, and histopathology/biopsy (composite standard of truth). In bone, the sensitivity of conventional imaging ranges between 30-50%. The null hypothesis is that the sensitivity at 50% will be tested against the alternative hypothesis that the sensitivity is greater than 50%.||100.00|97.85|<0.0000001
71651187|NCT00479388|142820337|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|1.6||0.006||95.0|-7.7|-1.3|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.||||-1.3|-7.7|0.006
71651188|NCT00479388|142820338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|13.4|17.9|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.||||17.9|13.4|<=0.001
71651189|NCT00479388|142820339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<=|0.001||95.0|-19.2|-11.7|||Repeated measures analysis|ANCOVA model based on Tukey's normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.||||-11.7|-19.2|<=0.001
71651190|NCT01876368|142820346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.19|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.73|-1.65|||ANCOVA|||||-1.65|-4.73|<0.001
71651191|NCT01955044|142820358|SUPERIORITY||Median Difference (Final Values)|1.23||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||DHA levels||||0.05
71651192|NCT02093923|142820370|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71651193|NCT02093923|142820370|SUPERIORITY||Percent Change in Mean Rate|-87.77||||0.005|TWO_SIDED|95.0|-97.18|-46.9|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-46.90|-97.18|0.0050
71651194|NCT02093923|142820370|SUPERIORITY||Percent Change in Mean Rate|-91.08||||0.0012||95.0|-97.93|-61.57|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-61.57|-97.93|0.0012
71651195|NCT02093923|142820371|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71651196|NCT02093923|142820371|SUPERIORITY||Percent Change in Mean Rate|-84.08|||<|0.0001|TWO_SIDED|95.0|-93.07|-63.46|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-63.46|-93.07|<.0001
71651197|NCT02093923|142820371|SUPERIORITY||Percent Change in Mean Rate|-87.84|||<|0.0001|TWO_SIDED|95.0|-94.81|-71.5|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-71.50|-94.81|<.0001
71651198|NCT02093923|142820372|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71651199|NCT02093923|142820372|SUPERIORITY||Percent Change in Mean Rate|-82.38|||<|0.0001|TWO_SIDED|95.0|-92.5|-58.64|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-58.64|-92.50|<.0001
71651200|NCT02093923|142820372|SUPERIORITY||Percent Change in Mean Rate|-87.02|||<|0.0001|TWO_SIDED|95.0|-94.55|-69.06|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-69.06|-94.55|<.0001
71703132|NCT04018001|142923469|SUPERIORITY||Hazard Ratio (HR)|0.9022||||0.2629|TWO_SIDED|95.0|0.7534|1.0803||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.0803|0.7534|0.2629
71703133|NCT04018001|142923470|SUPERIORITY|||||||0.0123|||||||t-test, 2 sided|||||||0.0123
71703134|NCT04018001|142923470|SUPERIORITY||Difference in Least Squares (LS) Means|0.0300853||||0.0047|TWO_SIDED|95.0|0.0092322|0.0509385||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0509385|0.0092322|0.0047
71703135|NCT04018001|142923471|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
71703136|NCT04018001|142923471|SUPERIORITY||Odds Ratio (OR)|1.7910474||||0.0002|TWO_SIDED|95.0|1.3167136|2.4362554||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||2.4362554|1.3167136|0.0002
71703137|NCT04018001|142923472|SUPERIORITY|||||||0.4071|||||||t-test, 2 sided|||||||0.4071
71703138|NCT04018001|142923472|SUPERIORITY||Difference in LS Means|0.0104065||||0.6143|TWO_SIDED|95.0|-0.030062|0.0508746||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0508746|-0.030062|0.6143
71703139|NCT04018001|142923473|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.0010
71703140|NCT04018001|142923473|SUPERIORITY||Odds Ratio (OR)|1.5211586||||0.0025|TWO_SIDED|95.0|1.1594614|1.9956882||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9956882|1.1594614|0.0025
71703141|NCT04018001|142923474|SUPERIORITY|||||||0.4595|||||||t-test, 2 sided|||||||0.4595
71703142|NCT04018001|142923474|SUPERIORITY||Hazard Ratio (HR)|1.1225||||0.3354|TWO_SIDED|95.0|0.8873|1.4201||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox|||||1.4201|0.8873|0.3354
71703143|NCT04018001|142923475|SUPERIORITY|||||||0.113|||||||t-test, 2 sided|||||||0.1130
71703144|NCT04018001|142923475|SUPERIORITY||Difference in LS Means|0.0151242||||0.1194|TWO_SIDED|95.0|-0.003908|0.0341568||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0341568|-0.003908|0.1194
71703145|NCT04018001|142923476|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.0200
71703146|NCT04018001|142923476|SUPERIORITY||Odds Ratio (OR)|1.4143816||||0.0364|TWO_SIDED|95.0|1.0221455|1.9571335||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.9571335|1.0221455|0.0364
71703147|NCT04018001|142923477|SUPERIORITY|||||||0.9031|||||||t-test, 2 sided|||||||0.9031
71703148|NCT04018001|142923477|SUPERIORITY||Difference in LS Means|-0.008587||||0.6376|TWO_SIDED|95.0|-0.044317|0.0271416||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model|||||0.0271416|-0.044317|0.6376
71703149|NCT04018001|142923478|SUPERIORITY|||||||0.3584|||||||Chi-squared|||||||0.3584
71703150|NCT04018001|142923478|SUPERIORITY||Odds Ratio (OR)|1.1077385||||0.451|TWO_SIDED|95.0|0.8489444|1.4454238||To better assess true effect of treatment,analysis with participant's baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic|||||1.4454238|0.8489444|0.4510
71703151|NCT04018001|142923479|SUPERIORITY|||||||0.0624|||||||Chi-squared|||||||0.0624
71703152|NCT04018001|142923480|SUPERIORITY|||||||0.4914|||||||Chi-squared|||||||0.4914
71703153|NCT03925220|142923505|SUPERIORITY||Prevalence Ratio (PR)|2.86|||<|0.001|TWO_SIDED|95.0|2.02|4.04||"At 3 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||A sample size of 400 parents and children was calculated to yield 80% power to detect one or more differences between the intervention and control arms, of 45% in talking about alcohol, 20% about marijuana, and 20% about other drugs, using a two-sided Bonferroni-corrected 1.5% level of significance (based on estimates from the pilot trial).||4.04|2.02|<0.001
71703154|NCT03925220|142923505|SUPERIORITY||Prevalence Ratio [PR]|2.4|||<|0.001|TWO_SIDED|95.0|1.67|3.45||"At 3 months:~Parent-reported frequency of conversations on using e-cigarettes or vaping"|Generalized estimation|||||3.45|1.67|<0.001
71703155|NCT03925220|142923505|SUPERIORITY||Prevalence Ratio [PR]|2.36|||<|0.001|TWO_SIDED|95.0|1.62|3.43||"At 3 months:~Parent-reported frequency of conversations on using marijuana"|Generalized estimation|||||3.43|1.62|<0.001
71703156|NCT03925220|142923505|SUPERIORITY||Prevalence Ratio [PR]|3.45|||<|0.001|TWO_SIDED|95.0|2.34|5.08||"At 3 months:~Parent-reported frequency of conversations on smoking cigarettes"|Generalized estimation|||||5.08|2.34|<0.001
71703157|NCT03925220|142923505|SUPERIORITY||Prevalence Ratio [PR]|2.47|||<|0.001|TWO_SIDED|95.0|1.58|3.86||"At 3 months:~Parent-reported frequency of conversations on using other drugs"|Generalized estimation|||||3.86|1.58|<0.001
71703158|NCT03925220|142923505|SUPERIORITY||Prevalence Ratio [PR]|1.45||||0.04|TWO_SIDED|95.0|1.02|2.06||"At 18 months:~Parent-reported frequency of conversations on drinking alcohol"|Generalized estimation|||||2.06|1.02|0.04
71703159|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio (PR)|1.31|||<|0.001|TWO_SIDED|95.0|1.18|1.45||"At 3 months:~Parent-reported have warned your child about the dangers of drinking alcohol and using drugs"|Generalized estimation|||||1.45|1.18|<0.001
71703160|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.55|||<|0.001|TWO_SIDED|95.0|1.32|1.83||"At 3 months:~Parent-reported 'have talked to your child about how to handle offers of alcoholic drinks and drugs'"|Generalized estimation|||||1.83|1.32|<0.001
71703161|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|2.13|||<|0.001|TWO_SIDED|95.0|1.73|2.63||"At 3 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||2.63|1.73|<0.001
71703162|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.67||||0.001|TWO_SIDED|95.0|1.25|2.25||"At 3 months:~Parent-reported 'have lectured or given your child a speech about drinking alcohol and using drugs'"|Generalized estimation|||||2.25|1.25|0.001
71703163|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.51|||<|0.001|TWO_SIDED|95.0|1.21|1.9||"At 3 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.90|1.21|<0.001
71703164|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.25||||0.008|TWO_SIDED|95.0|1.06|1.47||"At 3 months:~Parent-reported 'have told your child stories of people who drink alcohol, have been drunk, or use drugs'"|Generalized estimation|||||1.47|1.06|0.008
71651201|NCT02093923|142820373|SUPERIORITY||Percent Change in Mean Rate|-100.0|||<|0.0001|TWO_SIDED|95.0|-100.0|-100.0|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-100.00|-100.00|<.0001
71651202|NCT02093923|142820373|SUPERIORITY||Percent Change in Mean Rate|-85.24||||0.0141||95.0|-96.79|-32.03|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-32.03|-96.79|0.0141
71651203|NCT02093923|142820373|SUPERIORITY||Percent Change in Mean Rate|-89.35||||0.004|TWO_SIDED|95.0|-97.68|-51.13|||Mixed Models Analysis|||The result was based on General Estimating Equation (GEE) analysis. Generalized Estimating Equation (GEE) approach with Poisson distribution assumption was applied to the repeated-measures mixed model with independence working correlation structure. The treatment group was a fixed effect and the number of baseline HAE attacks per week was included as a covariate in the GEE.||-51.13|-97.68|0.0040
71651204|NCT00248170|142820374|SUPERIORITY_OR_OTHER|||||||0.315|||||||Log Rank|||||||0.3150
71651205|NCT01557582|142820382|SUPERIORITY_OR_OTHER||EDV percent difference|4.8|||||TWO_SIDED|95.0|2.24|7.56|||||Mean percent difference and 95% CI for EDV|||7.56|2.24|
71651206|NCT01557582|142820382|SUPERIORITY_OR_OTHER||ESV percent difference|1.76|||||TWO_SIDED|95.0|-1.17|4.76|||||Mean percent difference and 95% CI for ESV|||4.76|-1.17|
71651207|NCT01557582|142820382|SUPERIORITY_OR_OTHER||EF percent difference|2.03|||||TWO_SIDED|95.0|0.72|3.33|||||Mean percent difference and 95% CI for EF|||3.33|0.72|
71651208|NCT02413294|142820406|SUPERIORITY|||||||0.37||||||This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.|Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.37
71651209|NCT02413294|142820407|SUPERIORITY|||||||0.42|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.42
71651210|NCT02413294|142820408|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||0.65
71651211|NCT02413294|142820409|SUPERIORITY|||||||1|||||||Fisher Exact|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.||||1.0
71651212|NCT02413294|142820410|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
71651213|NCT02413294|142820411|SUPERIORITY|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.65
71651214|NCT02413294|142820412|SUPERIORITY|||||||0.94|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.94
71703165|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.1||"At 3 months:~Parent-reported 'have told your child you would be disappointed in her/him if they were to drink alcohol or use drugs'"|Generalized estimation|||||2.10|1.29|<0.001
71651215|NCT02413294|142820413|SUPERIORITY|||||||0.81|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.81
71651216|NCT02413294|142820414|SUPERIORITY|||||||0.4|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.40
71651217|NCT02413294|142820415|SUPERIORITY|||||||0.46|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.46
71651218|NCT02413294|142820416|SUPERIORITY||||||<|0.01|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||<0.01
71651219|NCT02413294|142820417|SUPERIORITY|||||||0.28|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.28
71651220|NCT02413294|142820418|SUPERIORITY|||||||0.67|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.67
71651221|NCT02413294|142820419|SUPERIORITY|||||||0.56|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.56
71703166|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.15||"At 3 months:~Parent-reported 'have shown your child information on the web, TV, or in the news about the dangers of drinking alcohol and using drugs'"|Generalized estimation|||||2.15|1.24|<0.001
71703167|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.65|||<|0.001|TWO_SIDED|95.0|1.4|1.93||"At 3 months:~Parent-reported 'have asked your child about their thoughts and opinions about drinking alcohol and using drugs'"|Generalized estimation|||||1.93|1.40|<0.001
71703168|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.4||||0.003|TWO_SIDED|95.0|1.12|1.74||"At 18 months:~Parent-reported 'have given your child rules to obey about drinking alcohol and using drugs'"|Generalized estimation|||||1.74|1.12|0.003
71651222|NCT02413294|142820420|SUPERIORITY|||||||0.82|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.||||0.82
71651223|NCT01631682|142820433|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
71703169|NCT03925220|142923506|SUPERIORITY||Prevalence Ratio [PR]|1.38||||0.01|TWO_SIDED|95.0|1.06|1.78||"At 18 months:~Parent-reported 'have made a comment to your child about how drinking alcohol and using drugs is bad if a character on TV is drinking or drunk'"|Generalized estimation|||||1.78|1.06|0.01
71703170|NCT05561140|142923516|SUPERIORITY||Difference in percentage|-0.3|||=|1|TWO_SIDED|95.0|-10.9|10.2|||Cochran-Mantel-Haenszel|||||10.2|-10.9|=1.0000
71703171|NCT05561140|142923518|SUPERIORITY||Least Square (LS) Mean Difference|-8.2|||=|0.0297|TWO_SIDED|95.0|-15.6|-0.8|||Mixed Models Analysis|||The mixed model for repeated measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for stratification factors.||-0.8|-15.6|=0.0297
71703172|NCT05561140|142923519|SUPERIORITY||Difference in percentage|-8.1|||=|0.3456|TWO_SIDED|95.0|-26.9|10.7|||Cochran-Mantel-Haenszel|||||10.7|-26.9|=0.3456
71703173|NCT06377488|142923520|SUPERIORITY||least-square mean estimate|-0.085|STANDARD_ERROR_OF_MEAN|0.0139|||TWO_SIDED|95.0|-0.115|-0.056|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at distance was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||-0.056|-0.115|
71703174|NCT06377488|142923520|SUPERIORITY||least-square mean estimate|-0.023|STANDARD_ERROR_OF_MEAN|0.0131|||TWO_SIDED|95.0|-0.05|0.005|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at intermediate was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.005|-0.050|
71703175|NCT06377488|142923520|SUPERIORITY||least-square mean estimate|0.083|STANDARD_ERROR_OF_MEAN|0.0152|||TWO_SIDED|95.0|0.051|0.116|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Visual Acuity scores at near was estimated using 95% confidence intervals (CI) constructed for the least-square mean (LSM).|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 9, 6 and 29 subjects were required to test the primary hypotheses for distance, intermediate and near, respectively.||0.116|0.051|
71703176|NCT06377488|142923521|SUPERIORITY||Mean Population Estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
71703177|NCT06377488|142923521|SUPERIORITY||Mean Population Estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes only using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a 1-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 29 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
71703178|NCT06377488|142923522|SUPERIORITY||Central Posterior Mean Estimate|0.943|STANDARD_DEVIATION|0.0155|||TWO_SIDED|95.0|0.908|0.968|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.902 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.968|0.908|
71703179|NCT06377488|142923523|SUPERIORITY||Central Posterior Mean Estimate|0.988|STANDARD_DEVIATION|0.0058|||TWO_SIDED|95.0|0.974|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 96% with 95% central posterior credible interval.||0.997|0.974|
71703180|NCT06377488|142923524|SUPERIORITY||Central Posterior Mean Estimate|0.006|STANDARD_DEVIATION|0.0047|||TWO_SIDED|95.0|0.0|0.017|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.017|0.000|
71703181|NCT06377488|142923525|SUPERIORITY||Central Posterior Mean Estimate|0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|0.0|0.011|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data||It was calculated that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.011|0.000|
71703182|NCT06377488|142923526|SUPERIORITY||Least-square mean estimate|57.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|51.7|64.0|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for hyperopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||64.0|51.7|
71703183|NCT06377488|142923526|SUPERIORITY||Least-square mean estimate|62.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|56.7|67.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|This is the analysis for myopes only. Mean estimates were conducted using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 42 and 55 subjects were required to test for superiority for CLUE vision scores for hyperopes and myopes, respectively.||67.5|56.7|
71824663|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
71824664|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
71824665|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.11
71824666|NCT00938340|143153439|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.16
71824667|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71824668|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.004
71824669|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.62
71886477|NCT00848354|143293347|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71824670|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.14
71651224|NCT01631682|142820433|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.||||>.05
71651225|NCT01631682|142820433|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||<.05
71651226|NCT01631682|142820433|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).||||>.05
71739297|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.629|||||TWO_SIDED|95.0|0.202|1.96||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.960|0.202|
71824671|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.002
71824672|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.22
71824673|NCT00938340|143153440|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.074
71824674|NCT00938340|143153441|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
71824675|NCT00938340|143153442|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71824676|NCT00938340|143153443|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71824677|NCT00938340|143153444|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71824678|NCT00938340|143153445|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71824679|NCT00938340|143153446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Mixed Models Analysis|||||||0.44
71824680|NCT00938340|143153447|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Mixed Models Analysis|||||||0.62
71651227|NCT02688387|142820520|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0667|||||TWO_SIDED|90.0|0.9657|1.1784|||||X1 Vs R1, ambrisentan|||1.1784|0.9657|
71824681|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
71824682|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.007
71824683|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.99
71824684|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.037
71824685|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0087||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.0087
71824686|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.64
71824687|NCT00938340|143153448|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis|||||||0.043
71824688|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71824689|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
71824690|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.21
71824691|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0011
71824692|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0004
71762788|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.96|<|0.0001|TWO_SIDED|95.0|-52.3|-36.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-36.8|-52.3|<0.0001
71651228|NCT02688387|142820520|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0353|||||TWO_SIDED|90.0|0.9293|1.1534|||||X2 Vs R2, ambrisentan|||1.1534|0.9293|
71651229|NCT02688387|142820520|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9839|||||TWO_SIDED|90.0|0.9288|1.0423|||||X1 Vs R1, tadalafil|||1.0423|0.9288|
71651230|NCT02688387|142820520|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9656|||||TWO_SIDED|90.0|0.9151|1.0188|||||X2 Vs R2, tadalafil|||1.0188|0.9151|
71651231|NCT02688387|142820521|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.03|||||TWO_SIDED|90.0|0.9965|1.0646|||||X1 Vs R1, ambrisentan|||1.0646|0.9965|
71651232|NCT02688387|142820521|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0141|||||TWO_SIDED|90.0|0.982|1.0473|||||X2 Vs R2, ambrisentan|||1.0473|0.9820|
71651233|NCT02688387|142820521|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9693|||||TWO_SIDED|90.0|0.931|1.0092|||||X1 Vs R1, tadalafil|||1.0092|0.9310|
71824693|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.11
71651234|NCT02688387|142820521|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0157|||||TWO_SIDED|90.0|0.9553|1.0799|||||X2 Vs R2, tadalafil|||1.0799|0.9553|
71651235|NCT02688387|142820522|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0278|||||TWO_SIDED|90.0|0.9943|1.0623|||||X1 Vs R1, ambrisentan|||1.0623|0.9943|
71762789|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.0001|TWO_SIDED|95.0|-46.7|-31.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-31.8|-46.7|<0.0001
71762790|NCT04518995|143027159|SUPERIORITY||LS Mean Difference|-47.0|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-55.1|-39.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-39.0|-55.1|<0.0001
71824694|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.53
71824695|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.59
71824696|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.31
71824697|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.98
71824698|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
71824699|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.91
71824700|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.12
71824701|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.007
71762791|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71651236|NCT02688387|142820522|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0144|||||TWO_SIDED|90.0|0.9832|1.0466|||||X2 Vs R2, ambrisentan|||1.0466|0.9832|
71651237|NCT02688387|142820522|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9612|||||TWO_SIDED|90.0|0.9265|0.9972|||||X1 Vs R1, tadalafil|||0.9972|0.9265|
71651238|NCT02688387|142820522|EQUIVALENCE|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg \& tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0122|||||TWO_SIDED|90.0|0.9562|1.0715|||||X2 Vs R2, tadalafil|||1.0715|0.9562|
71703184|NCT06377488|142923527|SUPERIORITY||Mean Population Estimate|64.7|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|58.6|70.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||70.8|58.6|
71651239|NCT02688387|142820523|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0153|||||TWO_SIDED|90.0|0.9348|1.1027|||||Y1 Vs R3, ambrisentan|||1.1027|0.9348|
71651240|NCT02688387|142820523|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9758|||||TWO_SIDED|90.0|0.9044|1.0529|||||Y1 Vs R3, tadalafil|||1.0529|0.9044|
71651241|NCT02688387|142820524|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.039|||||TWO_SIDED|90.0|1.0168|1.0617|||||Y1 Vs R3, ambrisentan|||1.0617|1.0168|
71703185|NCT06377488|142923527|SUPERIORITY||Mean Population Estimate|64.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|59.0|69.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 23 and 46 subjects were required to test for superiority for CLUE comfort scores for hyperopes and myopes, respectively.||69.5|59.0|
71703186|NCT06377488|142923528|SUPERIORITY||Mean Population Estimate|67.9|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|62.2|73.5|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for hyperopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||73.5|62.2|
71703187|NCT06377488|142923528|SUPERIORITY||Mean Population Estimate|67.0|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|62.2|71.8|||Mixed Model Analysis|The Satterthwaite Method was used for the calculation of the denominator degrees of freedom.|Mean estimates were conducted for myopes using two-sided confidence intervals (CI) constructed for the least square mean.|It was calculated using a one-sided one-sample mean t-test with a family wise type I error rate of 5% with at least 99% statistical power, that 15 and 26 subjects were required to test for superiority for CLUE handling scores for hyperopes and myopes, respectively.||71.8|62.2|
71703188|NCT06377488|142923529|SUPERIORITY||Central Posterior Mean Estimate|0.966|STANDARD_DEVIATION|0.0135|||TWO_SIDED|95.0|0.933|0.988|||Bayesian beta-binomial model|Bayesian beta-binomial model with correlated binary data.||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70 with 5000 replicating trials, that 140 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible.||0.988|0.933|
71703189|NCT00387127|142923554|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|10.7||||0.3658|TWO_SIDED|95.0|-13.4|37.3||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by an independent radiological review.|||37.3|-13.4|0.3658
71703190|NCT00387127|142923555|SUPERIORITY_OR_OTHER||Difference in percentage of par. with CR|28.8||||0.013|TWO_SIDED|95.0|5.7|53.6||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by the investigator.|||53.6|5.7|0.0130
71762792|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71651242|NCT02688387|142820524|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9806|||||TWO_SIDED|90.0|0.9106|1.056|||||Y1 Vs R3, tadalafil|||1.0560|0.9106|
71651243|NCT02688387|142820525|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0365|||||TWO_SIDED|90.0|1.0138|1.0596|||||Y1 Vs R3, ambrisentan|||1.0596|1.0138|
71651244|NCT02688387|142820525|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9821|||||TWO_SIDED|90.0|0.9145|1.0547|||||Y1 Vs R3, tadalafil|||1.0547|0.9145|
71824702|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0089
71824703|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.28
71824704|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
71824705|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.48
71824706|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||<0.0001
71824707|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0003
71824708|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.57
71824709|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.99
71739298|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.179|||||TWO_SIDED|95.0|0.411|3.376||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.376|0.411|
71824710|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.71
71824711|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.62
71824712|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.33
71824713|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.65
71824714|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.66
71824715|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.30
71824716|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0005
71824717|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.0085
71651245|NCT02688387|142820526|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1176|||||TWO_SIDED|90.0|1.0166|1.2287|||||Y2 Vs R4, ambrisentan|||1.2287|1.0166|
71651246|NCT02688387|142820526|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1196|||||TWO_SIDED|90.0|1.0429|1.2019|||||Y2 Vs R4, tadalafil|||1.2019|1.0429|
71651247|NCT02688387|142820527|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0353|||||TWO_SIDED|90.0|1.0009|1.071|||||Y2 Vs R4, ambrisentan|||1.0710|1.0009|
71824718|NCT00938340|143153449|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P \< 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis|||||||0.92
71824719|NCT03635112|143153458|SUPERIORITY||Least Square Mean Difference|-0.76||||0.97|TWO_SIDED|95.0|-40.62|39.11|||Mixed Model Repeated Measures Analysis|||||39.11|-40.62|0.970
71824720|NCT03635112|143153458|SUPERIORITY||Least Square Mean Difference|-13.13||||0.51|TWO_SIDED|95.0|-52.46|26.19|||Mixed Model Repeated Measures Analysis|||||26.19|-52.46|0.510
71824721|NCT03635112|143153459|SUPERIORITY||Difference in Proportion|-0.07||||0.5102|TWO_SIDED|95.0|-0.277|0.135|||Cochran-Mantel-Haenszel Chi-square Test|||||0.135|-0.277|0.5102
71651248|NCT02688387|142820527|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0362|||||TWO_SIDED|90.0|0.991|1.0834|||||Y2 Vs R4, tadalafil|||1.0834|0.9910|
71824722|NCT03635112|143153459|SUPERIORITY||Difference in Proportion|0.02||||0.8591|TWO_SIDED|95.0|-0.181|0.218|||Cochran-Mantel-Haenszel Chi-square Test|||||0.218|-0.181|0.8591
71824723|NCT03635112|143153460|SUPERIORITY||Difference in Proportion|-0.13||||0.1805|TWO_SIDED|95.0|-0.322|0.061|||Cochran-Mantel-Haenszel Chi-square Test|||||0.061|-0.322|0.1805
71824724|NCT03635112|143153460|SUPERIORITY||Difference in Proportion|-0.01||||0.9215|TWO_SIDED|95.0|-0.204|0.184|||Cochran-Mantel-Haenszel Chi-square Test|||||0.184|-0.204|0.9215
71824725|NCT03635112|143153461|SUPERIORITY||Least Square Mean Difference|1.6||||0.316|TWO_SIDED|95.0|-1.6|4.8|||ANCOVA|||||4.8|-1.6|0.316
71824726|NCT03635112|143153461|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-3.2|3.2|||ANCOVA|||||3.2|-3.2|0.988
71824727|NCT03635112|143153462|SUPERIORITY||Difference in Proportion|-0.11||||0.1828|TWO_SIDED|95.0|-0.27|0.059|||Cochran-Mantel-Haenszel Chi-square Test|||||0.059|-0.270|0.1828
71824728|NCT03635112|143153462|SUPERIORITY||Difference in Proportion|0.06||||0.5785|TWO_SIDED|95.0|-0.133|0.244|||Cochran-Mantel-Haenszel Chi-square Test|||||0.244|-0.133|0.5785
71824729|NCT03635112|143153463|SUPERIORITY||Difference in Proportion|-0.07||||0.3776|TWO_SIDED|95.0|-0.225|0.095|||Cochran-Mantel-Haenszel Chi-square Test|||||0.095|-0.225|0.3776
71824730|NCT03635112|143153463|SUPERIORITY||Difference in Proportion|-0.04||||0.6063|TWO_SIDED|95.0|-0.189|0.111|||Cochran-Mantel-Haenszel Chi-square Test|||||0.111|-0.189|0.6063
71651249|NCT02688387|142820528|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0351|||||TWO_SIDED|90.0|1.0002|1.0713|||||Y2 Vs R4, ambrisentan|||1.0713|1.0002|
71651250|NCT02688387|142820528|EQUIVALENCE|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0324|||||TWO_SIDED|90.0|0.9929|1.0734|||||Y2 Vs R4, tadalafil|||1.0734|0.9929|
71651251|NCT04403399|142820604|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
71651252|NCT04403399|142820605|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
71651253|NCT04403399|142820606|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
71651254|NCT00546910|142820619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.001|TWO_SIDED|95.0|0.52|0.87||P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.87|0.52|<0.001
71651255|NCT00546910|142820619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.98|1.57||P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.57|0.98|<0.001
71651256|NCT00546910|142820619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.81|1.35||P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.81|<0.001
71651257|NCT00546910|142820619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.78|1.22||P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.22|0.78|<0.001
71703191|NCT00387127|142923564|SUPERIORITY_OR_OTHER||Difference in overall response rate|16.3||||0.1969|TWO_SIDED|95.0|-8.6|42.1||From exact test that common odds ratio equals 1|Fisher Exact||Overall response was defined as the percentage of participants achieving a PR or CR as determined by the investigator.|||42.1|-8.6|0.1969
71703192|NCT05537571|142923575|SUPERIORITY||Mean Difference (Final Values)|-82.8|||<|0.0001|TWO_SIDED|95.0|-88.19|-77.39|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.39|-88.19|<0.0001
71703193|NCT05537571|142923575|SUPERIORITY||Mean Difference (Final Values)|-81.3|||<|0.0001|TWO_SIDED|95.0|-86.68|-76.0|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-76.0|-86.68|<0.0001
71651258|NCT00546910|142820619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.58|0.18|<0.001
71703194|NCT05537571|142923575|SUPERIORITY||Mean Difference (Final Values)|-85.6|||<|0.0001|TWO_SIDED|95.0|-90.88|-80.26|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-80.26|-90.88|<0.0001
71703195|NCT05537571|142923576|SUPERIORITY||Mean Difference (Final Values)|-83.1|||<|0.0001|TWO_SIDED|95.0|-88.7|-77.57|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.57|-88.7|<0.0001
71651259|NCT00546910|142820620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.6|||<|0.001|TWO_SIDED|95.0|8.2|14.99||P-value for ADHD-RS Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||14.99|8.20|<0.001
71651260|NCT00546910|142820621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11|||<|0.001|TWO_SIDED|95.0|0.76|1.46||P-value for CGI-S ADHD score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)||1.46|0.76|<0.001
71651261|NCT00546910|142820622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.74|||<|0.001|TWO_SIDED|95.0|3.55|7.92||P-value for Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||7.92|3.55|<0.001
71651262|NCT00546910|142820622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.001|TWO_SIDED|95.0|2.49|5.44||P-value for Evening subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||5.44|2.49|0.001
71651263|NCT00546910|142820622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||<|0.002|TWO_SIDED|95.0|0.42|1.93||P-value for Morning subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.93|0.42|<0.002
71824731|NCT05822440|143153476|OTHER||Ratio of Adjusted Geometric Means|124.35|||||TWO_SIDED|90.0|100.22|154.29||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||154.29|100.22|
71651264|NCT00546910|142820622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|||<|0.001|TWO_SIDED|95.0|0.31|0.93||P-value for Item 11 (difficulty falling asleep).|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.31|<0.001
71651265|NCT00546910|142820623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.66|1.35||P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.35|0.66|<0.001
71651266|NCT00546910|142820623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.93||P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.93|0.46|<0.001
71651267|NCT00546910|142820623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||<|0.001|TWO_SIDED|95.0|0.17|0.65||P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.65|0.17|<0.001
71651268|NCT00546910|142820623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.26|0.73||P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.73|0.26|<0.001
71651269|NCT00546910|142820624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|0.31|0.68||P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.68|0.31|<0.001
71651270|NCT00546910|142820624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.022|TWO_SIDED|95.0|0.02|0.31||P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.31|0.02|0.022
71651271|NCT00546910|142820625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.001|TWO_SIDED|95.0|0.69|1.18||P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||1.18|0.69|<0.001
71651272|NCT00546910|142820625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.178|TWO_SIDED|95.0|0.05|0.28||P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||||0.28|0.05|0.178
71651273|NCT01115855|142820626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.36||||||Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) covariates.||1.36|0.53|
71651274|NCT01115855|142820627|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.56|1.31||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.31|0.56|
71651275|NCT01115855|142820628|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.81|3.87||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.87|0.81|
71703196|NCT05537571|142923576|SUPERIORITY||Mean Difference (Final Values)|-78.7|||<|0.0001|TWO_SIDED|95.0|-84.18|-73.17|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.17|-84.18|<0.0001
71651276|NCT01115855|142820629|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.4|||||TWO_SIDED|95.0|0.92|6.24||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||6.24|0.92|
71651277|NCT01115855|142820630|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.44|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.44|
71651278|NCT01115855|142820631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.45|1.25||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.25|0.45|
71651279|NCT01115855|142820632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.45|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||0.97|0.45|
71651280|NCT01115855|142820633|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.49|1.33||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>=-50 ml/min/1.73 m\^2) covariates.||1.33|0.49|
71651281|NCT01115855|142820634|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.45|1.1||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.10|0.45|
71651282|NCT01115855|142820635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.53|1.28||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||1.28|0.53|
71703197|NCT05537571|142923576|SUPERIORITY||Mean Difference (Final Values)|-83.0|||<|0.0001|TWO_SIDED|95.0|-88.43|-77.49|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-77.49|-88.43|<0.0001
71739299|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.222|||||TWO_SIDED|95.0|0.438|3.414||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.414|0.438|
71824732|NCT05822440|143153477|OTHER||Ratio of Adjusted Geometric Means|212.83||||||90.0|183.76|246.5||||||Ratio was between test to reference, where test is PF-07817883 + Itraconazole arm and reference is PF-07817883 arm. Natural log transformed Cmax of PF-07817883 were analyzed using a mixed effect model with treatment as fixed effect and participant as a random effect. The ratios (and 90% CIs) were expressed as percentages.||246.50|183.76|
71824733|NCT02387749|143153495|SUPERIORITY|||||||0.005|||||||Chi-squared, Corrected|||||||0.005
71824734|NCT03568162|143153528|SUPERIORITY|The analysis was conducted using a mixed model for repeated measures (MMRM) model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit|LS Mean Difference|-20.192|STANDARD_ERROR_OF_MEAN|7.4781|=|0.008|TWO_SIDED|95.0|-34.944|5.439|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||5.439|-34.944|= 0.008
71824735|NCT03568162|143153528|SUPERIORITY|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|-14.439|STANDARD_ERROR_OF_MEAN|7.6622|=|0.061|TWO_SIDED|95.0|-29.552|0.674|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference|||0.674|-29.552|= 0.061
71824736|NCT03568162|143153528|SUPERIORITY|The analysis was conducted using a mixed MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.|LS Mean Difference|3.144|STANDARD_ERROR_OF_MEAN|7.8864|=|0.691|TWO_SIDED|95.0|-12.41|18.698|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|||18.698|-12.410|= 0.691
71824737|NCT03568162|143153528|SUPERIORITY||LS Mean Difference|-17.199|STANDARD_ERROR_OF_MEAN|6.409|=|0.008|TWO_SIDED|95.0|-29.895|-4.503|||Mixed Models Analysis||A linear contrast was used to estimate the treatment difference.|The analysis was conducted using a MMRM model for percent change from baseline in EASI with the corresponding baseline value as covariate, and treatment group, region, disease severity, visit as fixed effect factors, and interactions of treatment-by-visit, baseline-by-visit.||-4.503|-29.895|= 0.008
71824738|NCT02081391|143153566|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0404|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used SOAM as factors. For participants discontinuing treatment before 12 hours for any other reason than no further need of opioid analgesics or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||0|-0.09|0.0404
71824739|NCT02081391|143153567|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0154|TWO_SIDED|95.0|-0.18|-0.02|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used supplemental opioid analgesic medication (SOAM) as factors. For participants discontinuing treatment before 24 hours for any other reason than no further need of SOAM or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant's discontinuation.||-0.02|-0.18|0.0154
71824740|NCT03184428|143153583|OTHER||||||<|0.05|||||||Spearman's rank-order correlation|Bonferroni adjustment in addition||||||<0.05
71824741|NCT00126113|143153607|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
71824742|NCT00126113|143153608|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Analysis for main effect of group|ANOVA|||||||>0.05
71824743|NCT00126113|143153609|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
71703198|NCT05537571|142923577|SUPERIORITY||Mean Difference (Final Values)|-79.2|||<|0.0001|TWO_SIDED|95.0|-85.25|-73.1|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-73.1|-85.25|<0.0001
71824744|NCT00126113|143153610|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|Analysis for main effect of group||||||>0.05
71824745|NCT00561574|143153613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71651283|NCT01115855|142820636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.18|3.53||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||3.53|0.18|
71703199|NCT05537571|142923577|SUPERIORITY||Mean Difference (Final Values)|-71.8|||<|0.0001|TWO_SIDED|95.0|-77.81|-65.8|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-65.8|-77.81|<0.0001
71703200|NCT05537571|142923577|SUPERIORITY||Mean Difference (Final Values)|-77.1|||<|0.0001|TWO_SIDED|95.0|-83.09|-71.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-71.15|-83.09|<0.0001
71824746|NCT00561574|143153613|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824747|NCT00561574|143153614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824748|NCT00561574|143153614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824749|NCT00561574|143153615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824750|NCT00561574|143153615|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824751|NCT00561574|143153616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3129||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3129
71824752|NCT00561574|143153616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3154||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.3154
71824753|NCT00561574|143153617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824754|NCT00561574|143153617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824755|NCT00561574|143153618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824756|NCT00561574|143153618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824757|NCT00561574|143153619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||<0.0001
71824758|NCT00561574|143153619|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0001
71824759|NCT00561574|143153620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0116
71824760|NCT00561574|143153620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||Two-sided significance level of 0.05|t-test, 2 sided|||||||0.0004
71824761|NCT03860077|143153626|SUPERIORITY|Average cigarettes per day was positively skewed, with a non-normal residual distribution in a mixed model analysis specifying a normal (Gaussian) outcome distribution. Therefore, this outcome was recoded to integers and modeled as a count with a negative binomial distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Risk Ratio (RR)|1.42|STANDARD_ERROR_OF_MEAN|0.21||0.111|TWO_SIDED|95.0|0.92|2.19|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = 0.35.|These are results of a 2-group (VLNC \& NNC) x 2 repeated measures (Baseline \& Week 4) mixed effects model to test the effect of the randomization group (VLNC vs. NNC) on change in cigarette use and alternative tobacco product (ATP) use from Baseline to Week 4. Group (VLNC vs. NNC) is a fixed, between-subjects focal predictor. Timepoint (Baseline vs. Week 4) is a fixed, within-subjects repeated measure. Subject is a random effect, accounting for variability in Baseline cigarette and ATP use.||2.19|0.92|.111
71824762|NCT03860077|143153627|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.93||0.721|TWO_SIDED|95.0|0.11|4.75|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.34.|This outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.||4.75|.11|.721
71824763|NCT03860077|143153628|SUPERIORITY|Frequencies of non-combustible alternative product use (ATP) were bimodal with peaks at 0 (no use) and 7 (daily use). Therefore, this outcome was recoded as a dichotomous outcome with a binary distribution and log link. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Odds Ratio (OR)|0.57|STANDARD_ERROR_OF_MEAN|0.96||0.564|TWO_SIDED|95.0|0.08|3.99|||Mixed Models Analysis||The reported value is the standard error of the mean for the non-exponentiated estimate = - 0.56.|||3.99|.08|.564
71824764|NCT03860077|143153629|SUPERIORITY||Slope|0.25|STANDARD_ERROR_OF_MEAN|1.56||0.876|TWO_SIDED|95.0|-2.92|3.42|||Mixed Models Analysis|||The study cigarette outcome is modeled with a normal, Gaussian distribution. The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group. Baseline in this analysis is average number of usual brand cigarettes at baseline, prior to randomization.||3.42|-2.92|.876
71824765|NCT03860077|143153630|SUPERIORITY|The focal test is the difference in change from Baseline to Week 4 (i.e., Time) in the VLNC vs. NNC condition (i.e., Group), which is a cross-level interactive effect of Time and Group.|Slope|-2166.79|STANDARD_ERROR_OF_MEAN|1753.48||0.226|TWO_SIDED|95.0|-5743.04|1409.47|||Mixed Models Analysis|||||1409.47|-5743.04|.226
71651284|NCT01115855|142820637|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.07|17.85||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||17.85|0.07|
71651285|NCT01115855|142820638|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11|||||TWO_SIDED|95.0|0.39|11.56||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||11.56|0.39|
71824766|NCT00430677|143153748|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||0.746|TWO_SIDED|95.0|0.6|2.03||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.03|0.60|0.746
71824767|NCT00430677|143153748|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.6||||0.118|TWO_SIDED|95.0|0.89|2.83||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||2.83|0.89|0.118
71824768|NCT00430677|143153751|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.78|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.78|0.91|
71824769|NCT00430677|143153751|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|0.91|1.77|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.|||1.77|0.91|
71824770|NCT00430677|143153757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.68|21.3||||||||21.3|0.68|
71824771|NCT00430677|143153757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.49|1.59||||||||1.59|0.49|
71824772|NCT00430677|143153759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.19|-0.13|
71703201|NCT05537571|142923578|SUPERIORITY||Mean Difference (Final Values)|-13.3|||<|0.0001|TWO_SIDED|95.0|-18.55|-8.09|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.09|-18.55|<0.0001
71651286|NCT01115855|142820639|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.66||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||5.66|0.05|
71651287|NCT01115855|142820640|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.16|8.04||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30--\<50 ml/min/1.73 m\^2, \>-=50 ml/min/1.73 m\^2) covariates.||8.04|0.16|
71651288|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.93|STANDARD_ERROR_OF_MEAN|47.13|||TWO_SIDED|95.0|-195.92|-9.94||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-9.94|-195.92|
71824773|NCT00430677|143153759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||ANCOVA||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.|||0.14|-0.18|
71651289|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-95.77|STANDARD_ERROR_OF_MEAN|44.54|||TWO_SIDED|95.0|-184.51|-7.04||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-7.04|-184.51|
71651290|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-125.09|STANDARD_ERROR_OF_MEAN|35.15|||TWO_SIDED|95.0|-195.5|-54.68||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-54.68|-195.50|
71651291|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.94|STANDARD_ERROR_OF_MEAN|51.12|||TWO_SIDED|95.0|-232.77|-31.11||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-31.11|-232.77|
71651292|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-132.39|STANDARD_ERROR_OF_MEAN|52.77|||TWO_SIDED|95.0|-240.94|-23.84||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-23.84|-240.94|
71651293|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-117.18|STANDARD_ERROR_OF_MEAN|51.76|||TWO_SIDED|95.0|-221.49|-12.87||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-12.87|-221.49|
71651294|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-101.5|STANDARD_ERROR_OF_MEAN|61.05|||TWO_SIDED|95.0|-267.36|64.36||||||Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.36|-267.36|
71651295|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-110.78|STANDARD_ERROR_OF_MEAN|92.42|||TWO_SIDED|95.0|-307.49|85.93||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||85.93|-307.49|
71651296|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-119.62|STANDARD_ERROR_OF_MEAN|158.84|||TWO_SIDED|95.0|-2137.82|1898.59||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1898.59|-2137.82|
71651297|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-144.6|STANDARD_ERROR_OF_MEAN|200.56|||TWO_SIDED|90.0|-2692.95|2403.76||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||2403.76|-2692.95|
71651298|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-77.26|STANDARD_ERROR_OF_MEAN|966.09|||TWO_SIDED|95.0|-2131.88|1977.37||||||Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1977.37|-2131.88|
71824774|NCT00836810|143153792|SUPERIORITY||||||<|0.001||||||A priory test for statistical significance was P\<0.05|t-test, 2 sided|||||||<0.001
71824775|NCT00836810|143153792|SUPERIORITY||||||<|0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.001
71651299|NCT01115855|142820642|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-102.3|STANDARD_ERROR_OF_MEAN|35.67|||TWO_SIDED|95.0|-172.61|-32.0||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||-32.00|-172.61|
71651300|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-364.65|STANDARD_ERROR_OF_MEAN|763.83|||TWO_SIDED|95.0|-1863.06|1133.76||||||Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1133.76|-1863.06|
71651301|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-247.14|STANDARD_ERROR_OF_MEAN|711.26|||TWO_SIDED|95.0|-1642.43|1148.14||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1148.14|-1642.43|
71703202|NCT05537571|142923578|SUPERIORITY||Mean Difference (Final Values)|-9.9|||=|0.0002|TWO_SIDED|95.0|-15.02|-4.68|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.68|-15.02|=0.0002
71824776|NCT00836810|143153792|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||||||A priori statistical significance set as P\<0.05|t-test, 2 sided|||||||<0.01
71651302|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-370.14|STANDARD_ERROR_OF_MEAN|699.58|||TWO_SIDED|95.0|-1742.51|1002.22||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||1002.22|-1742.51|
71651303|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-664.09|STANDARD_ERROR_OF_MEAN|11059.62|||TWO_SIDED|95.0|-141189.93|139861.75||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||139861.75|-141189.93|
71651304|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-414.99|STANDARD_ERROR_OF_MEAN|3071.77|||TWO_SIDED|95.0|-39445.52|38615.54||||||Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||38615.54|-39445.52|
71651305|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|23.86|STANDARD_ERROR_OF_MEAN|10794.85|||TWO_SIDED|95.0|-21649.89|21697.6||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21697.60|-21649.89|
71651306|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-245.23|STANDARD_ERROR_OF_MEAN|6698.57|||TWO_SIDED|95.0|-85358.69|84868.22||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||84868.22|-85358.69|
71651307|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|170.49|STANDARD_ERROR_OF_MEAN|10730.38|||TWO_SIDED|95.0|-21375.69|21716.66||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||21716.66|-21375.69|
71651308|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-58.77|STANDARD_ERROR_OF_MEAN|12765.3|||TWO_SIDED|95.0|-30160.25|30042.7||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||30042.70|-30160.25|
71651309|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-212.25|STANDARD_ERROR_OF_MEAN|11073.11|||TWO_SIDED|90.0|-22723.82|22299.33||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||22299.33|-22723.82|
71651310|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-80.16|STANDARD_ERROR_OF_MEAN|11486.21|||TWO_SIDED|95.0|-146026.28|145865.96||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||145865.96|-146026.28|
71651311|NCT01115855|142820643|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-187.72|STANDARD_ERROR_OF_MEAN|240.96|||TWO_SIDED|95.0|-662.67|287.23||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||287.23|-662.67|
71651312|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-0.55|3.96||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||3.96|-0.55|
71824777|NCT00836810|143153793|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|A priori statistical significance set at P\<0.05||||||<0.001
71651313|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|95.0|0.07|5.42||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.42|0.07|
71824778|NCT00836810|143153793|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
71651314|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.86|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|1.11|6.6||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.60|1.11|
71651315|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.86|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.81|7.9||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.90|1.81|
71703203|NCT05537571|142923578|SUPERIORITY||Mean Difference (Final Values)|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.1|-9.82|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.82|-20.1|<0.0001
71703204|NCT05537571|142923579|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.62|-7.08|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.08|-17.62|<0.0001
71703205|NCT05537571|142923579|SUPERIORITY||Mean Difference (Final Values)|-8.6|||=|0.0013|TWO_SIDED|95.0|-13.85|-3.44|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.44|-13.85|=0.0013
71824779|NCT00836810|143153793|SUPERIORITY||||||<|0.01||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||<0.01
71824780|NCT00836810|143153794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.023
71824781|NCT00836810|143153794|SUPERIORITY|||||||0.0906||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.0906
71824782|NCT00836810|143153794|SUPERIORITY|||||||0.044||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.044
71824783|NCT00836810|143153795|SUPERIORITY|||||||0.007||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.007
71824784|NCT00836810|143153795|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
71824785|NCT00836810|143153795|SUPERIORITY|||||||0.57||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.57
71824786|NCT00836810|143153796|SUPERIORITY|||||||0.022||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.022
71824787|NCT00836810|143153796|SUPERIORITY|||||||0.002||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.002
71824788|NCT00836810|143153796|SUPERIORITY|||||||0.51||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.51
71824789|NCT00836810|143153797|SUPERIORITY|||||||0.003||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.003
71762793|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
71824790|NCT00836810|143153797|SUPERIORITY|||||||0.001||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||.001
71824791|NCT00836810|143153797|SUPERIORITY|||||||0.88||||||A priori statistical significance set at P\<0.05|t-test, 2 sided|||||||0.88
71824792|NCT00389519|143153866|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||two-sided test|ANCOVA|test from contrast statement from full model||"Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.~If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis."||||0.044
71824793|NCT00389519|143153867|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||two-sided, unadjusted|ANCOVA|test from contrast statement from full model||||||0.006
71824794|NCT00946192|143153871|OTHER|Least square means||||||0.039|||||||Mixed Models Analysis|||||||0.039
71824795|NCT00946192|143153872|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71824796|NCT04159506|143153916|SUPERIORITY||Median Difference (Final Values)|0.63|||<|0.05|TWO_SIDED|||||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.|Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||||||<0.05
71824797|NCT04159506|143153917|SUPERIORITY||Median Difference (Final Values)|0.31|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
71824798|NCT04159506|143153918|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|No adjustments were made given this was a pilot study focused on feasibility and acceptability.||This pilot study was designed mostly to determine feasibility and acceptability of TEE, AC, and study methods. Nonetheless, Paired Difference Signed Rank Tests were used to compare conditions given small sample and non-normal distribution of data.||||<0.05
71824799|NCT05642000|143153920|SUPERIORITY||Odds Ratio, log|0.187|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|-0.079|0.454|||Mixed Models Analysis|||||0.454|-0.079|
71824800|NCT02501629|143153949|SUPERIORITY||Odds Ratio (OR)|1.23||||0.468|TWO_SIDED|95.0|0.702|2.157||Significance at 0.05.|proportional odds model|factors for treatment group and randomization strata (age and OCS dose); baseline OCS dose and duration of OCS use prior to study were covariates.||The proportional odds ratio (reslizumab/placebo) was estimated from this model, representing the ratio of the odds of a patient outcome being in a higher OCS dose reduction category for reslizumab compared to placebo.||2.157|0.702|0.468
71824801|NCT02501629|143153950|SUPERIORITY||Odds Ratio (OR)|1.45||||0.234|TWO_SIDED|95.0|0.786|2.683||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.683|0.786|0.234
71824802|NCT02501629|143153951|SUPERIORITY||Odds Ratio (OR)|1.19||||0.596|TWO_SIDED|95.0|0.631|2.229||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.229|0.631|0.596
71824803|NCT02501629|143153952|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|10.759||0.101|TWO_SIDED|95.0|-38.986|3.494|||mixed model repeated measures (MMRM)||Reslizumab - Placebo|Mixed model repeated measures (MMRM) with fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.||3.494|-38.986|0.101
71824804|NCT02501629|143153953|SUPERIORITY||Odds Ratio (OR)|1.36||||0.341|TWO_SIDED|95.0|0.722|2.562||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||2.562|0.722|0.341
71824805|NCT02501629|143153954|SUPERIORITY||CAE rate ratio|0.82||||0.407|TWO_SIDED|95.0|0.504|1.321|||Negative binomial regression model|Negative binomial regression model adjusted for stratification factors (OCS dose group), age, number of prior exacerbations, and an offset variable.|reslizumab vs placebo|||1.321|0.504|0.407
71824806|NCT02501629|143153955|SUPERIORITY||Odds Ratio (OR)|0.82||||0.628|TWO_SIDED|95.0|0.371|1.818||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.||1.818|0.371|0.628
71824807|NCT02004613|143153958|SUPERIORITY||Risk Ratio (RR)|0.91||||0.34|TWO_SIDED|97.8|0.72|1.15|||Regression, Logistic|||Hypothesis: dexmedetomidine would reduce the incidence of postoperative atrial arrhythmias.||1.15|0.72|0.34
71824808|NCT02004613|143153959|SUPERIORITY||Risk Ratio (RR)|1.48||||0.026|TWO_SIDED|97.8|0.99|2.23|||Regression, Logistic|||hypothesis: Dexmedetomidine may reduce the incidence of postoperative delirium.||2.23|0.99|0.026
71824809|NCT02004613|143153960|SUPERIORITY||Risk Ratio (RR)|1.4||||0.14|TWO_SIDED|97.5|0.84|2.34|||Regression, Logistic|||||2.34|0.84|0.14
71651316|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|2.36|8.94||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.94|2.36|
71651317|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|0.12|6.75||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||6.75|0.12|
71651318|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.06|7.25||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.25|-0.06|
71651319|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.65|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|0.86|8.44||||||Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||8.44|0.86|
71651320|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.85|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|0.02|7.68||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||7.68|0.02|
71651321|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|90.0|0.08|9.25||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||9.25|0.08|
71824810|NCT02004613|143153961|OTHER||Risk Ratio (RR)|0.87||||0.29|TWO_SIDED|97.5|0.65|1.16|||Regression, Logistic|||||1.16|0.65|0.29
71824811|NCT00530335|143153976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824812|NCT00530335|143153976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824813|NCT00530335|143153976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824814|NCT00530335|143153976|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71651322|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-1.82|10.07||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||10.07|-1.82|
71703206|NCT05537571|142923579|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.2|-8.84|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.84|-19.2|<0.0001
71824815|NCT00530335|143153977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71703207|NCT05537571|142923580|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.81|-5.73|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-5.73|-16.81|<0.0001
71739300|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.778|||||TWO_SIDED|95.0|0.259|2.335||||||Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.335|0.259|
71824816|NCT00530335|143153977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824817|NCT00530335|143153977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824818|NCT00530335|143153977|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824819|NCT00530335|143153978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71824820|NCT00530335|143153979|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||t-test, 2 sided|||||||0.749
71824821|NCT00530335|143153980|SUPERIORITY_OR_OTHER|||||||0.886||95.0|||||t-test, 2 sided|||||||0.886
71824822|NCT00530335|143153982|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.005
71824823|NCT00530335|143153982|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||<0.001
71824824|NCT00530335|143153982|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided|||||||0.003
71824825|NCT01268891|143154009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.3257|TWO_SIDED|90.0|-0.93|0.23||The threshold for statistical significance in showing a trend for this study is 0.10.|ANCOVA|||The power for this study, which is designed to show a trend, that is, to show a clinical difference in the primary outcome measure, is 72%.||0.23|-0.93|0.3257
71824826|NCT01268891|143154010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0946|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||||0.05|-0.65|0.0946
71824827|NCT01268891|143154011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2258|TWO_SIDED|95.0|-1.84|0.44|||ANCOVA|||||0.44|-1.84|0.2258
71824828|NCT01268891|143154012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.98||0.17|TWO_SIDED|95.0|-3.29|0.59|||ANCOVA|||||0.59|-3.29|0.1700
71824829|NCT01720043|143154015|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||Collagen.5.g.ml, 24 hrs||||0.181
71824830|NCT01720043|143154015|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Collagen.2.g.ml||||.164
71824831|NCT01720043|143154015|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||ADP.10.M, 24 hrs||||.132
71824832|NCT01720043|143154015|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||ADP.5.M||||.066
71824833|NCT01720043|143154015|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||ADP.3.M, 24 hrs||||0.268
71824834|NCT01720043|143154015|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml||||0.106
71824835|NCT01720043|143154015|SUPERIORITY|||||||0.625|||||||t-test, 2 sided|||Ristocetin.1.5.mg.ml||||0.625
71824836|NCT01720043|143154015|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml||||0.381
71824837|NCT01720043|143154015|SUPERIORITY|||||||0.549|||||||t-test, 2 sided|||Collagen.5.g.ml, 48 hrs||||0.549
71824838|NCT01720043|143154015|SUPERIORITY|||||||0.838|||||||t-test, 2 sided|||Collagen.2.g.ml, 48 hrs||||.838
71824839|NCT01720043|143154015|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||ADP.10.M||||0.245
71824840|NCT01720043|143154015|SUPERIORITY|||||||0.417|||||||t-test, 2 sided|||ADP.5.M||||0.417
71824841|NCT01720043|143154015|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||ADP.3.M, 48 hrs||||0.770
71824842|NCT01720043|143154015|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml, 48 hrs||||0.614
71824843|NCT01720043|143154015|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||Ristochetin.1.5.mg.ml||||0.969
71824844|NCT01720043|143154015|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml, 48 hrs||||0.238
71824845|NCT02022462|143154021|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change of z-scores.||||.073
71824846|NCT02022462|143154021|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_DEVIATION|0.91||0.066|TWO_SIDED||||||t-test, 2 sided|||Within-group mean z-score change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.066
71824847|NCT02022462|143154022|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.983|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.983
71824848|NCT02022462|143154022|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|1.95||0.533|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.533
71824849|NCT02022462|143154023|SUPERIORITY|||||||0.731|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.731
71824850|NCT02022462|143154023|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||Within-group mean change from 6 months to 12-months (post-intervention) for the immediate treatment group only.||||.211
71824851|NCT02022462|143154024|SUPERIORITY||Mean Difference (Net)|0.04||||0.244|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.244
71824852|NCT02022462|143154024|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_DEVIATION|0.35||0.016|TWO_SIDED||||||t-test, 2 sided|||||||.016
71824853|NCT02022462|143154025|SUPERIORITY||Mean Difference (Net)|0.4||||0.019|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.019
71824854|NCT02022462|143154025|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.66||0.609|TWO_SIDED||||||t-test, 2 sided|||||||.609
71824855|NCT02022462|143154026|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.203
71824856|NCT02022462|143154026|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.59||0.48|TWO_SIDED||||||t-test, 2 sided|||||||.480
71824857|NCT02022462|143154027|SUPERIORITY||Mean Difference (Net)|0.01||||0.897|TWO_SIDED||||||t-test, 2 sided|||||||.897
71824858|NCT02022462|143154027|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.48||0.903|TWO_SIDED||||||t-test, 2 sided|||||||.903
71824859|NCT02022462|143154028|SUPERIORITY||Mean Difference (Net)|-0.787||||0.433|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.433
71824860|NCT02022462|143154028|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.52||0.936|TWO_SIDED||||||t-test, 2 sided|||||||.936
71824861|NCT02022462|143154029|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change in z-scores of diet.||||.228
71824862|NCT02022462|143154029|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.03||0.617|TWO_SIDED||||||t-test, 2 sided|||||||.617
71824863|NCT02022462|143154030|SUPERIORITY||Mean Difference (Net)|0.01||||0.894|TWO_SIDED||||||t-test, 2 sided|||||||.894
71824864|NCT02022462|143154030|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.46||0.93|TWO_SIDED||||||t-test, 2 sided|||||||.930
71824865|NCT02022462|143154031|SUPERIORITY||Mean Difference (Net)|0.15||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||.530
71824866|NCT02022462|143154031|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_DEVIATION|1.27||0.458|TWO_SIDED||||||t-test, 2 sided|||||||.458
71824867|NCT02022462|143154032|SUPERIORITY||Mean Difference (Net)|0.31||||0.036|TWO_SIDED||||||t-test, 2 sided|||||||.036
71651323|NCT01115855|142820644|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|0.56|5.8||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||5.80|0.56|
71824868|NCT02022462|143154032|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|1.0||0.892|TWO_SIDED||||||t-test, 2 sided|||||||.892
71824869|NCT02022462|143154033|SUPERIORITY||Mean Difference (Net)|0.41||||0.931|TWO_SIDED||||||t-test, 2 sided|||||||.931
71824870|NCT02022462|143154033|SUPERIORITY||Mean Difference (Net)|-6.43|STANDARD_DEVIATION|24.34||0.058|TWO_SIDED||||||t-test, 2 sided|||||||.058
71651324|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-61.53|STANDARD_ERROR_OF_MEAN|59.75|||TWO_SIDED|95.0|-186.44|63.37||||||Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||63.37|-186.44|
71824871|NCT02022462|143154034|SUPERIORITY||Mean Difference (Net)|0.4||||0.576|TWO_SIDED||||||t-test, 2 sided|||||||.576
71824872|NCT02022462|143154034|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_DEVIATION|33.89||0.829|TWO_SIDED||||||t-test, 2 sided|||||||.829
71824873|NCT02022462|143154035|SUPERIORITY|||||||0.792|||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.792
71824874|NCT02022462|143154035|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_DEVIATION|0.55||0.622|TWO_SIDED||||||t-test, 2 sided|||||||.622
71824875|NCT02022462|143154036|SUPERIORITY||Mean Difference (Net)|1.986||||0.049|TWO_SIDED||||||t-test, 2 sided|||Baseline to 6 months between-group comparisons of the mean change.||||.049
71824876|NCT02022462|143154036|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_DEVIATION|1.67||0.211|TWO_SIDED||||||t-test, 2 sided|||||||.211
71824877|NCT02796092|143154037|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.||||>0.999
71824878|NCT02796092|143154038|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.3
71824879|NCT02796092|143154039|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71824880|NCT02796092|143154040|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71824881|NCT02796092|143154041|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
71824882|NCT02796092|143154042|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71824883|NCT02796092|143154043|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71824884|NCT02796092|143154044|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71824885|NCT02796092|143154045|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71824886|NCT02796092|143154046|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71824887|NCT02796092|143154047|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71824888|NCT02796092|143154048|SUPERIORITY_OR_OTHER|||||||0.0499|||||||Chi-squared|||||||0.0499
71824889|NCT02796092|143154050|SUPERIORITY_OR_OTHER|||||||0.095|||||||Fisher Exact|||||||0.095
71824890|NCT02534896|143154051|SUPERIORITY|||||||0.018|||||||Hochberg and Gatekeeping|||||||0.018
71824891|NCT02534896|143154051|SUPERIORITY|||||||0.007|||||||Hochberg and Gatekeeping|||||||0.007
71824892|NCT02534896|143154052|SUPERIORITY|||||||0.028|||||||Hochberg and Gatekeeping|||||||0.028
71824893|NCT02534896|143154052|SUPERIORITY|||||||0.003|||||||Hochberg and Gatekeeping|||||||0.003
71824894|NCT02534896|143154053|SUPERIORITY|||||||0.96|||||||Hochberg and Gatekeeping|||||||0.960
71824895|NCT02534896|143154053|SUPERIORITY|||||||0.339|||||||Hochberg and Gatekeeping|||||||0.339
71824896|NCT02534896|143154054|SUPERIORITY|||||||0.573|||||||Hochberg and Gatekeeping|||||||0.573
71824897|NCT02534896|143154054|SUPERIORITY|||||||0.374|||||||Hochberg and Gatekeeping|||||||0.374
71824898|NCT01107626|143154055|SUPERIORITY|||||||0.12|||||||Log Rank|Stratified logrank test||||||0.12
71824899|NCT01107626|143154055|SUPERIORITY|||||||0.28|||||||Log Rank|Stratified logrank test||||||0.28
71824900|NCT04310579|143154076|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.22|ONE_SIDED|95.0||2.5||To demonstrate an effect of oxycodone with midazolam compared to oxycodone alone, it is necessary that the upper bound of the one-sided 95% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone with midazolam compared to oxycodone alone.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||2.5||0.22
71886478|NCT00848354|143293348|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0066
71703208|NCT05537571|142923580|SUPERIORITY||Mean Difference (Final Values)|-7.2|||=|0.0106|TWO_SIDED|95.0|-12.64|-1.69|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-1.69|-12.64|=0.0106
71703209|NCT05537571|142923580|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.04|-7.15|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.15|-18.04|<0.0001
71703210|NCT05537571|142923581|SUPERIORITY||Mean Difference (Final Values)|-31.9|||=|0.0051|TWO_SIDED|95.0|-54.07|-9.72|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-9.72|-54.07|=0.0051
71703211|NCT05537571|142923581|SUPERIORITY||Mean Difference (Final Values)|-29.7|||=|0.0081|TWO_SIDED|95.0|-51.62|-7.81|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.81|-51.62|=0.0081
71703212|NCT05537571|142923581|SUPERIORITY||Mean Difference (Final Values)|-25.1|||=|0.0241|TWO_SIDED|95.0|-46.89|-3.33|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-3.33|-46.89|=0.0241
71703213|NCT05537571|142923582|SUPERIORITY||Mean Difference (Final Values)|-29.8|||=|0.0023|TWO_SIDED|95.0|-48.86|-10.76|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-10.76|-48.86|=0.0023
71703214|NCT05537571|142923582|SUPERIORITY||Mean Difference (Final Values)|-27.4|||=|0.0046|TWO_SIDED|95.0|-46.23|-8.58|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.58|-46.23|=0.0046
71703215|NCT05537571|142923582|SUPERIORITY||Mean Difference (Final Values)|-26.0|||=|0.0068|TWO_SIDED|95.0|-44.67|-7.24|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-7.24|-44.67|=0.0068
71703216|NCT05537571|142923583|SUPERIORITY||Mean Difference (Final Values)|-28.7|||=|0.0057|TWO_SIDED|95.0|-48.91|-8.46|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-8.46|-48.91|=0.0057
71703217|NCT05537571|142923583|SUPERIORITY||Mean Difference (Final Values)|-26.1|||||TWO_SIDED|95.0|-46.13|-6.16||||||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-6.16|-46.13|
71703218|NCT05537571|142923583|SUPERIORITY||Mean Difference (Final Values)|-24.1||||0.0179|TWO_SIDED|95.0|-43.93|-4.2|||ANOVA|||Analysis of variance (ANOVA) was used to test for differences between each active treatment group and the pooled placebo groups in the primary outcome measure.||-4.2|-43.93|0.0179
71703219|NCT05494632|142923584|SUPERIORITY||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|||||the threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71886479|NCT00848354|143293348|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0036
71703220|NCT01059851|142923681|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval \[0.50, 2.00\], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.93|1.6|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants."||1.60|0.93|
71703221|NCT00223821|142923689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|7.65||0.16|TWO_SIDED|95.0|-5.13|25.54|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.||25.54|-5.13|.16
71703222|NCT00223821|142923690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|8.71||0.37|TWO_SIDED|95.0|-10.73|24.33|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||||24.33|-10.73|.37
71703223|NCT01039675|142923691|NON_INFERIORITY_OR_EQUIVALENCE|UMEC/VI will be declared non-inferior to placebo in terms of weighted mean pulse rate if the upper limit of the 95% confidence interval around the estimated treatment difference for weighted mean pulse rate is less than the non-inferiority margin of +10bpm.|Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-5.5|4.5|||||Estimated from repeated measures analysis of covariance.|||4.5|-5.5|
71703224|NCT03712852|142923772|SUPERIORITY||Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.68|1.17|||||||Multiple univariate analyses for each variable were performed. GT was analyzed by non-parametric Cliff's delta tests to assess group dominance and by a Heteroscedastic ANOVA with Games-Howell posthoc tests. A sensitivities analysis with different types of robust analyses (M-estimators and High Breakdown LTS Estimators, both with Huber's, Hampel's and Biweight's loss functions) was conducted to get an effect-size estimate by means of Bootstrap Bias Corrected and accelerated (BCa) 95% Confidence Intervals.|1.17|0.68|
71703225|NCT03712852|142923773|SUPERIORITY||Median Difference (Final Values)|3.28|||||TWO_SIDED|95.0|3.0|3.55|||||||This outcome was analyzed by posthoc Nemenyi's tests|3.55|3.00|
71703226|NCT03712852|142923774|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.46|2.46|||||||This outcome was analyzed by posthoc Nemenyi's tests|2.46|-0.46|
71651325|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.94|STANDARD_ERROR_OF_MEAN|54.2|||TWO_SIDED|95.0|-131.27|81.39||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||81.39|-131.27|
71651326|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.57|STANDARD_ERROR_OF_MEAN|43.18|||TWO_SIDED|95.0|-97.28|72.13||||||Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||72.13|-97.28|
71703227|NCT03712852|142923775|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.4|0.69|||||||This outcome was analyzed by posthoc Nemenyi's tests|0.69|-0.40|
71703228|NCT03712852|142923776|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|2.96|3.81|||||||CAL was analyzed with both Nemenyi's tests and a Moderated Regression (Treatment by Baseline values)|3.81|2.96|
71703229|NCT00138294|142923803|OTHER||Incidence Rate Ratio|0.89|||||TWO_SIDED|95.0|0.87|0.91||||||Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)||0.91|0.87|
71703230|NCT00138294|142923804|OTHER||Incidence Rate Ratio|0.69|||||TWO_SIDED|95.0|0.67|0.71||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.71|0.67|
71703231|NCT00138294|142923805|OTHER||Incidence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.73|0.76||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)||0.76|0.73|
71703232|NCT04764539|142923816|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|0.294|<|0.555|TWO_SIDED|95.0|-1.276|0.796||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The Mean Length of Utterance (MLU) will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||0.796|-1.276|<0.555
71703233|NCT04764539|142923816|SUPERIORITY||Mean Difference (Final Values)|0.5383|STANDARD_DEVIATION|0.659|<|0.2128|TWO_SIDED|95.0|-0.471|1.548||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.548|-0.471|<0.2128
71703234|NCT04764539|142923816|SUPERIORITY||Mean Difference (Final Values)|0.298|STANDARD_DEVIATION|0.365|<|0.533|TWO_SIDED|95.0|-0.915|1.511||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||1.511|-0.915|<0.533
71703235|NCT04764539|142923817|SUPERIORITY||Mean Difference (Final Values)|1.388|STANDARD_DEVIATION|1.7|<|0.289|TWO_SIDED|95.0|-1.763|4.539||Sample size too small for statistical power. In addition, automated speech recognition for child speech had a very poor state-of-the-art at the time of this study.|ANOVA||Difference = (iPad Pro group - VR goggles group)|The percentage of correctly transcribed words using automatic speech recognition will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||4.539|-1.763|<0.289
71703236|NCT04764539|142923818|SUPERIORITY||Mean Difference (Final Values)|-3.51|STANDARD_DEVIATION|4.3||0.4296|TWO_SIDED|95.0|-49.68|42.66||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|Articulation Accuracy does not statistically differ for the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||42.66|-49.68|0.4296
71703237|NCT04764539|142923818|SUPERIORITY||Mean Difference (Final Values)|19.75|STANDARD_DEVIATION|24.19|<|0.294|TWO_SIDED|95.0|-25.7|65.2||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||65.2|-25.7|<0.294
71703238|NCT04764539|142923818|SUPERIORITY||Mean Difference (Final Values)|16.25|STANDARD_DEVIATION|19.9|<|0.419|TWO_SIDED|95.0|-33.86|66.36||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||66.36|-33.86|<0.419
71703239|NCT04764539|142923819|SUPERIORITY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.63|<|0.659|TWO_SIDED|95.0|-6.436|9.096||Sample size to small for statistical power.|ANOVA||difference = (iPad group mean - VR goggles group mean)|||9.096|-6.436|<0.659
71703240|NCT04764539|142923820|SUPERIORITY||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|9.67|<|0.789|TWO_SIDED|95.0|-68.91|84.7|||ANOVA|Sample size too small for statistical power.|Difference = (iPad Pro group - VR Goggles group)|||84.7|-68.91|<0.789
71703241|NCT04764539|142923820|SUPERIORITY||Mean Difference (Final Values)|30.16|STANDARD_DEVIATION|36.94|<|0.304|TWO_SIDED|95.0|-40.85|101.17||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||101.17|-40.85|<0.304
71703242|NCT04764539|142923820|SUPERIORITY||Mean Difference (Final Values)|22.26|STANDARD_DEVIATION|27.26|<|0.403|TWO_SIDED|95.0|-43.91|88.43||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||88.43|-43.91|<0.403
71703243|NCT04764539|142923821|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_DEVIATION|2.87|<|0.485|TWO_SIDED|95.0|-10.79|6.11||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group - iPad Pro group)|The response to treatment stimuli will not increase from baseline for the either the iPad Pro or VR goggle participant group after having used the VAST system for 2 months.||6.11|-10.79|<0.485
71739301|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.929|||||TWO_SIDED|95.0|0.37|2.327||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.327|0.370|
71739302|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.083|||||TWO_SIDED|95.0|0.427|2.749||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.749|0.427|
71739303|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
71651327|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-78.47|STANDARD_ERROR_OF_MEAN|72.78|||TWO_SIDED|95.0|-221.25|64.31||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||64.31|-221.25|
71651328|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-79.63|STANDARD_ERROR_OF_MEAN|67.42|||TWO_SIDED|95.0|-211.88|52.63||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||52.63|-211.88|
71651329|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|19.35|STANDARD_ERROR_OF_MEAN|88.95|||TWO_SIDED|95.0|-230.01|268.71||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||268.71|-230.01|
71651330|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.05|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|95.0|-194.21|152.11||||||Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||152.11|-194.21|
71651331|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.79|STANDARD_ERROR_OF_MEAN|79.91|||TWO_SIDED|95.0|-197.55|115.97||||||Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||115.97|-197.55|
71651332|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-44.48|STANDARD_ERROR_OF_MEAN|103.29|||TWO_SIDED|95.0|-247.11|158.15||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.15|-247.11|
71651333|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.69|STANDARD_ERROR_OF_MEAN|107.06|||TWO_SIDED|90.0|-238.31|182.93||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||182.93|-238.31|
71651334|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.46|STANDARD_ERROR_OF_MEAN|96.48|||TWO_SIDED|95.0|-221.17|158.24||||||Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||158.24|-221.17|
71651335|NCT01115855|142820645|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|28.85|||TWO_SIDED|95.0|-58.91|54.83||||||Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||54.83|-58.91|
71651336|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.21|0.37||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.37|-0.21|
71651337|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.34|0.3||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.30|-0.34|
71651338|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.27|0.39||||||Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.39|-0.27|
71703244|NCT04764539|142923821|SUPERIORITY||Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|6.94|<|0.065|TWO_SIDED|95.0|-0.569|11.9||Sample size is too small for statistical power.|ANOVA||Difference = (iPad Pro group Post-Treatment - iPad Pro group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||11.9|-0.569|<0.065
71651339|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.41|0.45||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.45|-0.41|
71651340|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.56|0.24||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.24|-0.56|
71651341|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.55|0.25||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.25|-0.55|
71651342|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.49|0.31||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.31|-0.49|
71824901|NCT04310579|143154077|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.01|ONE_SIDED|97.5||-0.6||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-0.6||0.01
71824902|NCT04310579|143154077|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.28|ONE_SIDED|97.5||2.8||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||2.8||0.28
71824903|NCT04310579|143154078|SUPERIORITY||Mean Difference (Final Values)|-10.2|||<|0.001|ONE_SIDED|97.5||-6.3||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.3||<0.001
71824904|NCT04310579|143154078|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.37|ONE_SIDED|97.5||3.2||To demonstrate an effect of oxycodone with quetiapine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||3.2||0.37
71824905|NCT04310579|143154079|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.005|ONE_SIDED|95.0||-2.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||-2.5||0.005
71886480|NCT00848354|143293348|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71651343|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.44||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.44|-0.57|
71651344|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.5|0.54||||||Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.54|-0.50|
71739304|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.759|||||TWO_SIDED|95.0|0.295|1.952||||||Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||1.952|0.295|
71739305|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.875|||||TWO_SIDED|95.0|0.285|2.682||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.682|0.285|
71739306|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.366|||||TWO_SIDED|95.0|0.466|4.006||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||4.006|0.466|
71739307|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.235|2.394||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||2.394|0.235|
71703245|NCT04764539|142923821|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_DEVIATION|4.09|<|0.549|TWO_SIDED|95.0|-10.85|17.53||Sample size is too small for statistical power.|ANOVA||Difference = (VR goggles group Post-Treatment - VR goggles group Pre-Treatment)|Comparison of pre-test and post-test outcome per group.||17.53|-10.85|<0.549
71651345|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.44|0.83||||||Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.83|-0.44|
71651346|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.63|0.89||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.89|-0.63|
71651347|NCT01115855|142820647|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11||||||Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-\<50 ml/min/1.73 m\^2, \>=50 ml/min/1.73 m\^2) and baseline value.||0.11|-0.36|
71651348|NCT02960438|142820655|SUPERIORITY||Difference of arms|2.2||||0.374|TWO_SIDED|95.0|-19.96|24.46|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||24.46|-19.96|0.374
71651349|NCT02960438|142820655|SUPERIORITY||Difference of arms|11.1||||0.102|TWO_SIDED|95.0|-7.42|29.64|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||29.64|-7.42|0.102
71651350|NCT02960438|142820655|SUPERIORITY||Difference of arms|9.3||||0.188|TWO_SIDED|95.0|-9.25|27.77|||Regression, Logistic||Estimate was calculated based on the normal approximation to the binomial distribution.|||27.77|-9.25|0.188
71651351|NCT02322788|142820690|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.52|2.29|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.29|1.52|<0.001
71651352|NCT02322788|142820690|SUPERIORITY_OR_OTHER||Estimated mean ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.46|2.2|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||2.20|1.46|<0.001
71651353|NCT02322788|142820690|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.13|0.75|
71651354|NCT02322788|142820690|NON_INFERIORITY_OR_EQUIVALENCE|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.||1.08|0.72|
71651355|NCT02760264|142820694|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71651356|NCT02760264|142820696|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71651357|NCT02760264|142820698|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71651358|NCT02760264|142820699|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71651359|NCT02760264|142820701|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71651360|NCT02760264|142820703|OTHER|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."|||
71651361|NCT05918822|142820711|OTHER|A mixed-effects model was applied to log (ln)-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as random effect. Point estimates and their associated 90% confidence intervals (CIs) were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimate and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|82.19|||||TWO_SIDED|90.0|74.31|90.91|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||90.91|74.31|
71651362|NCT05918822|142820711|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|57.72|||||TWO_SIDED|90.0|52.18|63.84|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||63.84|52.18|
71651363|NCT05918822|142820711|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir Cmax with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|49.03|||||TWO_SIDED|90.0|40.07|60.0|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of Cmax of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||60.00|40.07|
71703246|NCT02827708|142923834|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.0|<0.0001
71651364|NCT05918822|142820712|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|97.59|||||TWO_SIDED|90.0|91.39|104.2|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||104.20|91.39|
71651365|NCT05918822|142820712|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|82.05|||||TWO_SIDED|90.0|76.84|87.61|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||87.61|76.84|
71651366|NCT05918822|142820712|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUClast with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|70.0|||||TWO_SIDED|90.0|60.11|81.51|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUClast of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||81.51|60.11|
71651367|NCT05918822|142820713|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment B (test) versus Treatment A (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (GMR) (%)|99.94|||||TWO_SIDED|90.0|94.12|106.11|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 1: Treatment B (Test) versus Treatment A (Reference)||106.11|94.12|
71703247|NCT02827708|142923834|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.0|||<|0.0001||95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
71703248|NCT02827708|142923835|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.8|-3.2|<0.0001
71703249|NCT02827708|142923835|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.9||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.9|-3.5|<0.0001
71703250|NCT02827708|142923851|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.64|||=|0.1834|TWO_SIDED|95.0|0.34|1.23||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.23|0.34|=0.1834
71703251|NCT02827708|142923852|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.43|||=|0.061|TWO_SIDED|95.0|0.17|1.04||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.04|0.17|=0.0610
71703252|NCT01137812|142923874|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.|Least-Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.064|<|0.05|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference \[canagliflozin minus sitagliptin\] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.||-0.250|-0.500|<0.05
71703253|NCT01137812|142923875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.3|2.48|||Regression, Logistic|||||2.48|1.30|
71703254|NCT01137812|142923876|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.89|-18.24|||ANCOVA|||||-18.24|-29.89|<0.001
71703255|NCT01137812|142923877|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.3|-2.2|||ANCOVA|||||-2.2|-3.3|<0.001
71703256|NCT01137812|142923878|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|0.883|<|0.001|TWO_SIDED|95.0|-7.642|-4.175|||ANCOVA|||||-4.175|-7.642|<0.001
71703257|NCT01137812|142923879|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.9||0.554|TWO_SIDED|95.0|-9.8|5.3|||ANCOVA|||||5.3|-9.8|0.554
71703258|NCT01137812|142923880|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|4.6|9.3|||ANCOVA|||||9.3|4.6|<0.001
71703259|NCT04621760|142923883|SUPERIORITY|||||||0.51||||||a priori threshold for statistical significance: 0.05|Fisher Exact|||||||0.51
71762794|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
71703260|NCT04621760|142923884|SUPERIORITY|||||||0.62||||||threshold for significance: 0.05|Fisher Exact|one sided Fisher's exct test, given small cell sizes.||||||0.62
71703261|NCT04621760|142923885|SUPERIORITY|||||||0.207||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small sample size||||||0.207
71703262|NCT04621760|142923886|SUPERIORITY|||||||0.496||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.496
71703263|NCT04621760|142923887|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly identifying PrEP is a daily pill to prevent HIV"||||0.02
71703264|NCT04621760|142923887|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion correctly responding to prompt: PrEP is for all adults"||||0.01
71703265|NCT04621760|142923887|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified: PrEP will not work if taken once a week"||||<0.01
71703266|NCT04621760|142923887|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test of proportion who correctly identified PrEP does not prevent STDs other than HIV"||||<0.01
71703267|NCT04621760|142923887|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, PrEP side effects do not last forever"||||<0.01
71703268|NCT04621760|142923887|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified, A baby could be norm to HIV discordant parents without transmitting HIV"||||0.03
71703269|NCT04621760|142923887|SUPERIORITY||||||<|0.01||||||a priori threshold for significance: 0.05|Chi-squared|||"Test comparing proportion who correctly identified There is medication you can take after sex to prevent HIV"||||<0.01
71703270|NCT04621760|142923887|SUPERIORITY|||||||0.29||||||a priori threshold for significance: 0.05|Chi-squared|||"Test for proportion who correctly identified PrEP efficacy is \> 95%"||||0.29
71739308|NCT00999518|142991309|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.063|||||TWO_SIDED|95.0|0.356|3.168||||||Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.||3.168|0.356|
71739309|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.263||||0.5731|TWO_SIDED|95.0|0.56|2.848|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.848|0.560|0.5731
71739310|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.656||||0.2592|TWO_SIDED|95.0|0.689|3.98|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||3.980|0.689|0.2592
71739311|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9181||||1.045|TWO_SIDED|95.0|0.452|2.417|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.417|0.452|1.045
71739312|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.306||||0.5289|TWO_SIDED|95.0|0.569|2.997|||Regression, Logistic|||Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.||2.997|0.569|0.5289
71886481|NCT00848354|143293349|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
71703271|NCT04621760|142923888|SUPERIORITY|||||||0.04||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.04
71703272|NCT04621760|142923889|SUPERIORITY|||||||0.02||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.02
71703273|NCT04621760|142923890|SUPERIORITY|||||||0.05||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.05
71703274|NCT04621760|142923891|SUPERIORITY|||||||0.03||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.03
71703275|NCT04621760|142923892|SUPERIORITY|||||||0.07||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.07
71703276|NCT04621760|142923893|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong positive skew of responses, transformed into a binary variable comparing those with lowest possible score versus higher score. Data then tested through tests of proportions.||||0.10
71703277|NCT04621760|142923894|SUPERIORITY|||||||0.22||||||a priori threshold for significance: 0.05|Chi-squared|||Given strong negative skew of responses, transformed into a binary variable comparing those with highest possible score versus higher score. Data then tested through tests of proportions.||||0.22
71703278|NCT04621760|142923895|SUPERIORITY|||||||0.51||||||a priori threshold for significance: 0.05|Fisher Exact|Fisher's exact test used due to small cell size||||||0.51
71703279|NCT04621760|142923896|SUPERIORITY|||||||0.9||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PrEP||||0.90
71703280|NCT04621760|142923896|SUPERIORITY|||||||0.75||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use abstinence||||0.75
71703281|NCT04621760|142923896|SUPERIORITY|||||||0.32||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use PEP||||0.32
71703282|NCT04621760|142923896|SUPERIORITY|||||||0.4||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use HIV testing||||0.40
71703283|NCT04621760|142923896|SUPERIORITY|||||||0.34||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use STD testing||||0.34
71886482|NCT00848354|143293349|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0013
71703284|NCT04621760|142923896|SUPERIORITY|||||||0.1||||||a priori threshold for significance: 0.05|Fisher Exact|||Comparing confidence between treatment groups of those who said they intended to use Treatment as Prevention||||0.10
71703285|NCT04621760|142923897|SUPERIORITY|||||||0.01||||||a priori threshold for significance: 0.05|Chi-squared|||||||0.01
71703286|NCT04621760|142923898|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt The information was easy to understand"||||0.26
71703287|NCT04621760|142923898|SUPERIORITY|||||||0.26||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: I got all of the information I needed"||||0.26
71703288|NCT04621760|142923898|SUPERIORITY|||||||0.59||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.59
71703289|NCT04621760|142923898|SUPERIORITY|||||||0.17||||||a priori threshold for significance: 0.05|Fisher Exact|||"Comparing proportions in response to prompt: The information felt useful to me"||||0.17
71703290|NCT04621760|142923899|SUPERIORITY|||||||0.74|||||||Chi-squared|||"Testing proportion of acceptability of abstinence method (proportion that responded great for me)"||||0.74
71703291|NCT04621760|142923899|SUPERIORITY|||||||0.59|||||||Chi-squared|||"Testing proportion of acceptability of condoms method (proportion that responded great for me)"||||0.59
71703292|NCT04621760|142923899|SUPERIORITY|||||||0.66|||||||Chi-squared|||"Testing proportion of acceptability of PEP method (proportion that responded great for me)"||||0.66
71703293|NCT04621760|142923899|SUPERIORITY|||||||0.49|||||||Chi-squared|||"Testing proportion of acceptability of PrEP method (proportion that responded great for me)"||||0.49
71703294|NCT04621760|142923899|SUPERIORITY|||||||0.94|||||||Chi-squared|||"Testing proportion of acceptability of HIV testing method (proportion that responded great for me)"||||0.94
71703295|NCT04621760|142923899|SUPERIORITY|||||||0.95|||||||Chi-squared|||"Testing proportion of acceptability of STD testing method (proportion that responded great for me)"||||0.95
71703296|NCT04621760|142923899|SUPERIORITY|||||||0.39|||||||Chi-squared|||"Testing proportion of acceptability of Treatment as prevention method (proportion that responded great for me)"||||0.39
71703297|NCT04621760|142923905|SUPERIORITY|||||||0.13||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.13
71703298|NCT04621760|142923906|SUPERIORITY|||||||0.08||||||a priori threshold for significance: 0.05|Fisher Exact|||||||0.08
71703299|NCT04602000|142923911|SUPERIORITY||Difference estimated using CMH weights|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.7|-4.5|||Cochran-Mantel-Haenszel|P-value was calculated using CMH test stratified by age (≥60 vs. \<60 years), baseline comorbidities (Yes vs. No) and region (US vs. EU vs. Other)|The 95% stratified Newcombe CI with CMH weights was presented.|||-4.5|-11.7|<0.0001
71703300|NCT01846871|142923934|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
71824906|NCT04310579|143154079|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.37|ONE_SIDED|95.0||3.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of midazolam compared to placebo, it is necessary that the upper bound of the one-sided 95% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of midazolam compared to placebo.|Part 1 is powered with consideration to both the effect of oxycodone versus placebo and oxycodone plus midazolam versus oxycodone. Assuming a -4 L/min effect size on VE55 and standard deviation of 5 L/min, there is greater than 90% power at a one-sided 0.05 significance level for a sample size of 20 subjects.||3.7||0.37
71824907|NCT04310579|143154080|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|ONE_SIDED|97.5||-3.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.9||<0.001
71824908|NCT04310579|143154080|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.67|ONE_SIDED|97.5||6.4||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of quetiapine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of quetiapine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 1 and day 5) with adjustment for multiplicity (α=.025). The assessments with paroxetine or quetiapine were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||6.4||0.67
71824909|NCT04310579|143154082|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.33|TWO_SIDED|90.0|0.96|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.96|0.33
71824910|NCT04310579|143154082|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.25|||<|0.001|TWO_SIDED|90.0|1.14|1.37||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.37|1.14|<0.001
71824911|NCT04310579|143154083|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.3|||<|0.001|TWO_SIDED|90.0|1.19|1.43||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.43|1.19|<0.001
71886483|NCT00848354|143293349|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||0.0002
71651368|NCT05918822|142820713|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs were constructed for differences between Treatment C (test) versus Treatment B (reference). Point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment B.|Geometric Mean Ratio (GMR) (%)|81.68|||||TWO_SIDED|90.0|76.93|86.73||||||Comparison of AUC0-infinity of Maribavir: Part 1: Treatment C (Test) versus Treatment B (Reference)||86.73|76.93|
71651369|NCT05918822|142820713|OTHER|A mixed-effects model was applied to ln-transformed plasma maribavir AUC0-infinity with treatment as a fixed effect, and participant as a random effect. Point estimates and their associated 90% CIs were constructed for the differences between Treatment E (test) versus Treatment D (reference). The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for the ratios of Treatment E versus Treatment D.|Geometric Mean Ratio (GMR) (%)|88.92|||||TWO_SIDED|90.0|76.94|102.78|||||GMR (%) was calculated as 100\*(Test/Reference).|Comparison of AUC0-infinity of Maribavir: Part 2: Treatment E (Test) versus Treatment D (Reference)||102.78|76.94|
71703301|NCT01846871|142923935|OTHER|||||||0.028|||||||t-test, 2 sided|||||||0.028
71703302|NCT01846871|142923936|OTHER|||||||0.0019|||||||t-test, 2 sided|||||||0.0019
71703303|NCT01846871|142923937|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
71703304|NCT00471354|142923938|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Spearman Partial Rank Order Correlation|||||||0.293
71703305|NCT00471354|142923939|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||P-value for Correlation with Language Scores|Spearman Partial Rank Order Correlation|||||||0.276
71703306|NCT00471354|142923939|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for Correlation with Math Scores.|Spearman Partial Rank Order Correlation|||||||0.110
71824912|NCT04310579|143154083|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.39|||<|0.001|TWO_SIDED|90.0|1.22|1.57||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Maximum oxycodone concentration was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.57|1.22|<0.001
71824913|NCT04310579|143154085|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.03||||0.64|TWO_SIDED|90.0|0.91|1.17||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.17|0.91|0.64
71824914|NCT04310579|143154085|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.24|TWO_SIDED|90.0|0.98|1.15||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 1 with treatment as a categorical variable and participant as a random effect||1.15|0.98|0.24
71824915|NCT04310579|143154086|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.1||||0.05|TWO_SIDED|90.0|1.02|1.19||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.19|1.02|0.05
71824916|NCT04310579|143154086|EQUIVALENCE|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.27|||<|0.001|TWO_SIDED|90.0|1.19|1.36||Secondary analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of oxycodone and quetiapine compared to oxycodone and placebo.|Area under the curve was log-transformed and the values between study treatments were compared using a linear mixed effects model on day 5 with treatment as a categorical variable and participant as a random effect||1.36|1.19|<0.001
71824917|NCT03710564|143154087|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4537|TWO_SIDED|95.0|-2.1|0.9|||Pairwise ANOVA|||||0.9|-2.1|0.4537
71824918|NCT02002819|143154114|SUPERIORITY||Mean Difference (Net)|0.07||||0.55|TWO_SIDED|95.0|-0.18|0.32|||ANOVA|||||0.32|-0.18|0.55
71824919|NCT02002819|143154115|SUPERIORITY||Mean Difference (Net)|2.9||||0.14|TWO_SIDED|95.0|-1.0|6.8|||ANOVA|||||6.8|-1.0|0.14
71824920|NCT02002819|143154116|SUPERIORITY||Mean Difference (Net)|-1.0||||0.43|TWO_SIDED|95.0|-3.4|1.5|||ANOVA|||||1.5|-3.4|.43
71824921|NCT02002819|143154117|SUPERIORITY||Mean Difference (Net)|0.1||||0.63|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||||0.4|-0.2|0.63
71824922|NCT02002819|143154118|SUPERIORITY||Mean Difference (Net)|0.1||||0.9|TWO_SIDED|95.0|-1.1|1.3|||ANOVA|||||1.3|-1.1|0.90
71824923|NCT02002819|143154119|SUPERIORITY||Mean Difference (Net)|0.0||||0.8|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|||||0.3|-0.3|0.80
71824924|NCT02002819|143154120|SUPERIORITY||Mean Difference (Net)|-1.0||||0.46|TWO_SIDED|95.0|-3.6|1.7|||ANOVA|||||1.7|-3.6|0.46
71824925|NCT02002819|143154121|SUPERIORITY||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.9|1.1|||ANOVA|||||1.1|-0.9|0.40
71824926|NCT02002819|143154122|SUPERIORITY||Mean Difference (Net)|7.4||||0.046|TWO_SIDED|95.0|0.2|14.7|||ANOVA|||||14.7|0.2|0.046
71824927|NCT02002819|143154123|SUPERIORITY||Mean Difference (Net)|-2.5||||0.3|TWO_SIDED|95.0|-7.8|2.7|||ANOVA|||||2.7|-7.8|.30
71824928|NCT02002819|143154124|SUPERIORITY||Mean Difference (Net)|3.8||||0.52|TWO_SIDED|95.0|-8.5|16.0|||Cohen f|||||16.0|-8.5|0.52
71824929|NCT02002819|143154125|SUPERIORITY||Mean Difference (Net)|0.7||||0.4|TWO_SIDED|95.0|-1.0|2.4|||ANOVA|||||2.4|-1.0|0.40
71824930|NCT02002819|143154126|SUPERIORITY||Mean Difference (Net)|-0.2||||0.63|TWO_SIDED|95.0|-1.1|0.7|||ANOVA|||||0.7|-1.1|0.63
71824931|NCT02002819|143154128|SUPERIORITY||Mean Difference (Net)|0.8||||0.15|TWO_SIDED|95.0|-0.3|1.8|||ANOVA|||||1.8|-0.3|.15
71824932|NCT03055767|143154145|SUPERIORITY|||||||0.038|||||||Wilcoxon signed-rank test|||||||0.038
71824933|NCT03055767|143154146|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
71824934|NCT03055767|143154147|SUPERIORITY|||||||0.148|||||||Wilcoxon signed-rank test)|||||||0.148
71824935|NCT03055767|143154148|SUPERIORITY|||||||0.047|||||||Wilcoxon signed-rank test)|||||||0.047
71824936|NCT03055767|143154149|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test)|||||||0.002
71824937|NCT03055767|143154150|SUPERIORITY|||||||0.82|||||||McNemar|||||||0.82
71824938|NCT03055767|143154151|SUPERIORITY|||||||0.006|||||||McNemar|||||||0.006
71703307|NCT00471354|142923939|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for Correlation with Science Scores.|Spearman Partial Rank Order Correlation|||||||0.464
71824939|NCT03055767|143154152|SUPERIORITY|||||||0.039|||||||McNemar|||||||0.039
71824940|NCT03055767|143154153|SUPERIORITY|||||||0.016|||||||McNemar|||||||0.016
71824941|NCT03055767|143154154|SUPERIORITY|||||||0.18|||||||McNemar|||||||0.18
71824942|NCT03055767|143154155|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test)|||||||<0.001
71824943|NCT03055767|143154156|SUPERIORITY|||||||0.64|||||||Wilcoxon signed-rank test)|||||||0.64
71824944|NCT02427737|143154171|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
71824945|NCT02427737|143154171|SUPERIORITY|||||||0.3037||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.3037
71762795|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71651370|NCT01796964|142820717|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 12 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-1.13|||||TWO_SIDED|80.0|-4.19|1.93|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 12.||1.93|-4.19|
71703308|NCT00471354|142923940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Language Scores.|Paired t-test|||||||<0.001
71703309|NCT00471354|142923940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Math Scores.|Paired t-test|||||||<0.001
71703310|NCT00471354|142923940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Science Scores.|Paired t-test|||||||<0.001
71703311|NCT00471354|142923940|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline in Total Scores.|Paired t-test|||||||<0.001
71703312|NCT00471354|142923941|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71703313|NCT00471354|142923942|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71703314|NCT00471354|142923944|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71703315|NCT00923702|142923984|NON_INFERIORITY|To test for non-inferiority of antibody concentrations in different dose groups, log-transformed mean MFIs in linear regression models were used to obtain MFI ratios and their corresponding 95% confidence intervals (CIs). Antibody titres at months 0, 7, 12, 36 and 48 were compared and non-inferiority was inferred when the lower bound of the confidence interval of the ratio of the immunogenicity measures exceeded 0.5.|Risk Ratio (RR)|0.5|||||ONE_SIDED||||||Regression, Linear||The lower bound of the 95% CI ratio of immunogeneicity measures was used instead. No p-values were estimated.|||||
71703316|NCT00923702|142923985|SUPERIORITY||Vaccine efficacy|95.0|||||TWO_SIDED|||||||||||||
71703317|NCT02942407|142924015|NON_INFERIORITY|Due to a lower recruitment rate than anticipated in the early stage of the trial, the sample size was curtailed from 760 to 230 patients. Thus, under the initial protocol assumptions, the study is considered under-powered for the two-sided upper 95% CI on the HR to rule-out the non-inferiority margin of 1.40.|Hazard Ratio (HR)|1.2||||0.321|TWO_SIDED|95.0|0.63|2.3|||Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin)|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|Exploratory analysis due to failure to reach initial sample size: Non-inferiority (NI) null hypothesis: HR \>= 1.4 (Non-inferiority).||2.3|0.63|0.321
71703318|NCT02942407|142924015|SUPERIORITY|Exploratory analysis due to lack of achieving initial sample size.|Hazard Ratio (HR)|1.2||||0.583|TWO_SIDED|95.0|0.63|2.3||If upper limit of 95% confidence interval \< 1 this would be considered evidence of superiority.|Regression, Cox|Cox model was adjusted for prior warfarin status (naive vs experienced) and treatment (apixaban vs warfarin).|Time from randomization to first occurrence of outcome was modeled. If no event, censored at earliest of: most recent date of evaluation of outcome, month 15 target (460 days + randomization date), or end of study date (July 27, 2019).|||2.3|0.63|0.583
71703319|NCT02942407|142924017|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.74|2.93||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of study date (July 27, 2019).||2.93|0.74|
71703320|NCT02942407|142924026|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.67|2.17||No p-value provided as analysis is considered exploratory due to study being under powered.||||Hazard ratios (apixaban vs warfarin) and 95% confidence intervals obtained using Cox model adjusted for prior warfarin status (naive vs experienced) and treatment. Time from randomization to first occurrence of the composite outcome/censoring date modeled. Those that did not experience the outcome are censored at the earliest of the following: 1) most recent date of evaluation of all of the components, 2) month 15 target (460 days + randomization date), and end of stud date (July 27, 2019).||2.17|0.67|
71703321|NCT05073315|142924043|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Ratio Geometric Least Square Mean (GMR)|1.0516|||||TWO_SIDED|90.0|0.901|1.2273||||||||1.2273|0.9010|
71703322|NCT05073315|142924044|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Least Square Mean Ratio|1.0044|||||TWO_SIDED|90.0|0.8717|1.1574||||||||1.1574|0.8717|
71703323|NCT05073315|142924047|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean Difference (Final Values)|-2.47|||||TWO_SIDED|90.0|-5.23|0.29||||||||0.29|-5.23|
71703324|NCT01529268|142924054|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.8|2.1|||Cochran-Mantel-Haenszel|||||2.1|0.8|0.34
71703325|NCT01529268|142924055|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.90
71703326|NCT01529268|142924056|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.7||||0.15|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Steatosis: patients with improvement||1.1|0.5|0.15
71703327|NCT01529268|142924057|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.59|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Steatosis: change in score||0.4|-0.2|0.59
71703328|NCT01529268|142924058|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.8||||0.03|TWO_SIDED|95.0|1.1|2.9|||Cochran-Mantel-Haenszel|||||2.9|1.1|0.03
71703329|NCT01529268|142924059|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.06|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.06
71703330|NCT01529268|142924060|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.8||||0.29|TWO_SIDED|95.0|0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|0.4|0.29
71703331|NCT01529268|142924061|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.15|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|||||0.3|-0.1|0.15
71703332|NCT01529268|142924062|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.2||||0.57|TWO_SIDED|95.0|0.6|2.3|||Cochran-Mantel-Haenszel|||||2.3|0.6|0.57
71703333|NCT01529268|142924063|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.76
71703334|NCT01529268|142924064|SUPERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.6|1.6|||Cochran-Mantel-Haenszel|||||1.6|0.6|0.98
71703335|NCT01529268|142924065|SUPERIORITY|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.24|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.24
71703336|NCT01529268|142924066|NON_INFERIORITY|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|2.7||||0.29|TWO_SIDED|95.0|0.4|18.3|||Cochran-Mantel-Haenszel|Stratified by clinic and weight group||||18.3|0.4|0.29
71703337|NCT01529268|142924067|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks in serum alanine aminotransferase on treatment group and baseline value of serum alanine aminotransferase.|Adjusted difference in mean changes|-24.0||||0.02|TWO_SIDED|95.0|-44.0|-4.0|||ANCOVA|Adjusted for baseline serum alanine aminotransferase||Adjusted difference in mean changes in serum alanine aminotransferase (ALT). The change in ALT is adjusted for the baseline ALT value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-44|0.02
71703338|NCT01529268|142924067|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in serum aspartate aminotransferase on treatment group and baseline value of serum aspartate aminotransferase.|Mean Difference (Net)|-15.0||||0.008|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA|Adjusted for baseline serum aspartate aminotransferase.||Adjusted difference in mean changes in serum aspartate aminotransferase (AST). The change in AST is adjusted for the baseline AST value; therefore, the adjusted difference in mean changes is not equal to the net change.||-4|-26|0.008
71703339|NCT01529268|142924067|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in gamma-glutamyl transpeptidase on treatment group and baseline value of gamma-glutamyl transpeptidase.|Mean Difference (Net)|-7.0||||0.02|TWO_SIDED|95.0|-13.0|-1.0|||ANCOVA|Adjusted for baseline gamma-glutamyl transpeptidase||Adjusted difference in mean changes in serum gamma-glutamyl transpeptidase (GGT). The change in GGT is adjusted for the baseline GGTvalue; therefore, the adjusted difference in mean changes is not equal to the net change.||-1|-13|0.02
71703340|NCT01529268|142924068|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-value and adjusted difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in weight (kg) on treatment group and baseline weight (kg).|Adjusted difference in mean changes|-1.5||||0.25|TWO_SIDED|95.0|-4.1|1.1|||ANCOVA|Adjusted for baseline weight (kg).||Adjusted difference in mean changes in weight (kg). The change in weight is adjusted for the baseline weight value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.1|-4.1|0.25
71703341|NCT01529268|142924069|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Adjusted difference in mean changes|-0.3||||0.42|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|Adjusted for baseline BMI (kg/m2)||Adjusted difference in mean changes in body mass index (BMI). The change in BMI is adjusted for the baseline BMI value; therefore, the adjusted difference in mean changes is not equal to the net change.||0.5|-1.1|0.42
71703342|NCT01529268|142924070|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Mean Difference (Net)|-0.1||||0.11|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|||||0.0|-0.1|0.11
71703343|NCT01529268|142924071|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in waist circumference on treatment group and baseline value of waist circumference.|Adjusted difference in mean changes|0.2||||0.89|TWO_SIDED|95.0|-2.3|2.6|||ANCOVA|Adjusted for baseline waist circumference (cm)||Adjusted difference in mean changes in waist circumference (cm). The change in waist circumference is adjusted for the baseline waist circumference value; therefore, the adjusted difference in mean changes is not equal to the net change.||2.6|-2.3|0.89
71703344|NCT01529268|142924072|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting serum glucose on treatment group and baseline fasting serum glucose value.|Adjusted difference in mean changes|-4.0||||0.24|TWO_SIDED|95.0|-11.0|3.0|||ANCOVA|Adjusted for baseline serum glucose value.||Adjusted difference in mean changes in fasting serum glucose. The change in fasting serum glucose is adjusted for the baseline fasting serum glucose value; therefore, the adjusted difference in mean changes is not equal to the net change.||3|-11|0.24
71824946|NCT02427737|143154171|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.01
71824947|NCT02427737|143154172|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.0001
71824948|NCT02427737|143154172|SUPERIORITY|||||||0.201||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||0.2010
71824949|NCT02427737|143154172|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
71824950|NCT02427737|143154173|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Comparison among trained and untrained sites||||<0.0001
71824951|NCT02427737|143154173|SUPERIORITY|||||||0.303||||||"Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.~Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2)."|Chi-squared|||Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites||||0.303
71824952|NCT02427737|143154173|SUPERIORITY||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter||||<0.001
71824953|NCT02427737|143154174|SUPERIORITY||||||<|0.0001||||||CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.|Chi-squared, Corrected|Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.||||||<0.0001
71824954|NCT02427737|143154175|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71824955|NCT02427737|143154177|SUPERIORITY|||||||0.2357||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.2357
71824956|NCT02427737|143154177|SUPERIORITY|||||||0.8523||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter||||0.8523
71824957|NCT02427737|143154177|SUPERIORITY|||||||0.5883||||||Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.|Chi-squared|||Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites||||0.5883
71824958|NCT02427737|143154178|SUPERIORITY|||||||0.0195||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||0.0195
71824959|NCT02427737|143154178|SUPERIORITY|||||||0.276||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows compared to the baseline quarter||||0.276
71824960|NCT02427737|143154178|SUPERIORITY|||||||0.2764||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter at untrained sites||||0.2764
71824961|NCT02427737|143154179|SUPERIORITY||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites||||<0.01
71824962|NCT02427737|143154179|SUPERIORITY|||||||0.9012||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the quarterly average no show rate as compared to the baseline quarter for trained sites||||0.9012
71824963|NCT02427737|143154179|SUPERIORITY|||||||0.9065||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites||||0.9065
71824964|NCT02427737|143154180|SUPERIORITY||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6||Comparison among trained and untrained sites over time||||<0.0001
71824965|NCT02427737|143154185|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71824966|NCT02427737|143154186|SUPERIORITY|||||||0.2396|||||||Chi-squared|||||||0.2396
71824967|NCT02427737|143154187|SUPERIORITY|||||||0.5267|||||||Chi-squared|||||||0.5267
71824968|NCT02427737|143154188|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71824969|NCT02427737|143154189|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71762796|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71824970|NCT00335556|143154190|OTHER||Log Rank Test Statistic|5.419||||0.0199|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.||||.0199
71824971|NCT00335556|143154191|OTHER||Log Rank Test Statistic|0.8814||||0.3478|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.3478
71824972|NCT00335556|143154193|OTHER||Log Rank Test Statistic|3.6216||||0.057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.||||.0570
71824973|NCT00478556|143154197|SUPERIORITY_OR_OTHER||difference in proportions|62.0|||<|0.001|||||||Binomial test of proportion|tested if values were different from 50%||All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.||||<0.001
71824974|NCT00478556|143154198|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.||||0.270
71824975|NCT02974010|143154199|SUPERIORITY|||||||0.03||||||BDM LS difference overall|Mixed Models Analysis|BDM LS difference overall||||||.03
71762797|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
71703345|NCT01529268|142924073|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting insulin on treatment group and baseline fasting insulin.|Adjusted difference in mean changes|-6.0||||0.34|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Adjusted for baseline fasting insulin.||Adjusted difference in mean changes in fasting insulin. The change in fasting insulin is adjusted for the baseline fasting insulin value; therefore, the adjusted difference in mean changes is not equal to the net change.||6|-18|0.34
71703346|NCT01529268|142924074|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in HOMA-IR on treatment group and baseline HOMA-IR value.|Adjusted difference in mean changes|-2.6||||0.15|TWO_SIDED|95.0|-6.2|1.0|||ANCOVA|Adjusted for baseline HOMA-IR.||Adjusted difference in mean changes in HOMA-IR. The change in HOMA-IR is adjusted for the baseline HOMA-IR value; therefore, the adjusted difference in mean changes is not equal to the net change.||1.0|-6.2|0.15
71703347|NCT01529268|142924075|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in systolic blood pressure on treatment group and baseline systolic blood pressure value.|Adjusted difference in mean changes|1.0||||0.71|TWO_SIDED|95.0|-3.0|4.0|||ANCOVA|Adjusted for baseline systolic blood pressure.||Adjusted difference in mean changes in systolic blood pressure. The change in systolic blood pressure is adjusted for the baseline systolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||4|-3|0.71
71703348|NCT01529268|142924076|SUPERIORITY|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in diastolic blood pressure on treatment group and baseline diastolic blood pressure value.|Adjusted difference in mean changes|-1.0||||0.31|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|Adjusted for baseline diastolic blood pressure.||Adjusted difference in mean changes in diastolic blood pressure. The change in diastolic blood pressure is adjusted for the baseline diastolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.||1|-4|0.31
71703349|NCT01529268|142924077|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in self-reported Physical Health summary score on treatment group and baseline value of the Physical Health summary score.|Adjusted difference in mean changes|-1.0||||0.77|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline self-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in self-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Physical Health summary score is adjusted for the baseline Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.77
71703350|NCT01529268|142924077|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in Pyschosocial Health summary score on treatment group and baseline Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.64|TWO_SIDED|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline Psychosocial Health summary score.||Adjusted difference in mean changes from baseline in self-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Psychosocial Health summary score is adjusted for the baseline Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||3|-5|0.64
71703351|NCT01529268|142924077|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Physical Health summary score on treatment group and baseline value of the parent/guardian-reported Physical Health summary score.|Adjusted difference in mean changes|-2.0||||0.58|TWO_SIDED|95.0|-9.0|5.0|||ANCOVA|Adjusted for baseline parent/guardian-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in parent/guardian-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Physical Health summary score is adjusted for the baseline parent/guardian-reported Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-9|0.58
71703352|NCT01529268|142924077|SUPERIORITY|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Psychosocial Health summary score on treatment group and baseline value of the parent/guardian-reported Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.85|TWO_SIDED|95.0|-6.0|5.0|||ANCOVA|||Adjusted difference in mean changes from baseline in parent/guardian-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Psychosocial Health summary score is adjusted for the baseline parent/guardian-reported Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.||5|-6|0.85
71703353|NCT01529268|142924078|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
71703354|NCT00699751|142924101|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||5e-05|TWO_SIDED|95.0|0.578|0.827|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.827|0.578|0.00005
71762798|NCT04518995|143027160|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
71824976|NCT02107014|143154267|SUPERIORITY_OR_OTHER|||||||0.576|||||||Mixed Models Analysis|||||||.576
71824977|NCT02107014|143154268|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.010
71703355|NCT00699751|142924102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.169|||<|1e-05|TWO_SIDED|95.0|0.131|0.22|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.22|0.131|<0.00001
71703356|NCT00699751|142924103|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71824978|NCT02107014|143154269|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||.008
71824979|NCT02107014|143154270|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||||||.015
71824980|NCT02107014|143154271|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||.007
71703357|NCT00699751|142924103|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703358|NCT00699751|142924103|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=30%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703359|NCT00699751|142924103|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703360|NCT00699751|142924104|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703361|NCT00699751|142924104|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703362|NCT00699751|142924104|SUPERIORITY_OR_OTHER||||||<|0.001||||||Confirmed Total ALP Response (\>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71824981|NCT02107014|143154272|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||.016
71824982|NCT02107014|143154273|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71824983|NCT02107014|143154274|SUPERIORITY_OR_OTHER|||||||0.212|||||||Mixed Models Analysis|||||||0.212
71824984|NCT02107014|143154277|SUPERIORITY_OR_OTHER|||||||0.008|||||||Mixed Models Analysis|||||||0.008
71824985|NCT02107014|143154278|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71703363|NCT00699751|142924105|SUPERIORITY_OR_OTHER||||||<|0.001||||||Total ALP normalization|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703364|NCT00699751|142924106|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage Change from Baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703365|NCT00699751|142924107|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline to week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703366|NCT00699751|142924108|SUPERIORITY_OR_OTHER||||||<|0.001||||||Percentage change from baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71824986|NCT02107014|143154279|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71824987|NCT02107014|143154280|SUPERIORITY_OR_OTHER|||||||0.047|||||||Mixed Models Analysis|||||||0.047
71824988|NCT02107014|143154281|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71824989|NCT02107014|143154282|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71824990|NCT02107014|143154283|SUPERIORITY_OR_OTHER|||||||0.191|||||||Mixed Models Analysis|||||||0.191
71824991|NCT02107014|143154284|SUPERIORITY_OR_OTHER|||||||0.088|||||||Mixed Models Analysis|||||||0.088
71824992|NCT02107014|143154285|SUPERIORITY_OR_OTHER|||||||0.478|||||||Mixed Models Analysis|||||||0.478
71824993|NCT02107014|143154288|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
71651371|NCT01796964|142820718|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority at week 16 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 - EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-0.58|||||TWO_SIDED|80.0|-3.72|2.56|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (\< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 16.||2.56|-3.72|
71651372|NCT04025684|142820726|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.11|-0.08||Analysis was performed using ANCOVA Model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.11|<.0001
71762799|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71762800|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71762801|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
71762802|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||<0.0001
71762803|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71762804|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71762805|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
71762806|NCT04518995|143027161|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||<0.0001
71762807|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.7|-1.2|<0.0001
71762808|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.9|-1.5|<0.0001
71762809|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.4|<0.0001
71762810|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|<0.0001
71762811|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.2|-1.8|<0.0001
71762812|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.3|-1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.6|-2.3|<0.0001
71762813|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
71762814|NCT04518995|143027162|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|<0.0001
71762815|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.3|-0.9|<0.0001
71762816|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-0.6|-1.3|<0.0001
71762817|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-0.9|-1.6|<0.0001
71762818|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.1|<0.0001
71762819|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.7|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.0|-1.7|<0.0001
71651373|NCT04025684|142820726|SUPERIORITY||Adjusted Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.14|-0.1||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.10|-0.14|<0.0001
71651374|NCT04025684|142820726|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
71651375|NCT04025684|142820726|SUPERIORITY||Adjusted Mean Change|-0.1|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.12|-0.08||Analysis was performed using ANCOVA model with product group as a fixed effect and the baseline mean RPI overall value as a covariate.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.08|-0.12|<0.0001
71651376|NCT04025684|142820727|SUPERIORITY||Adjusted Mean Change|-0.5|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.62|-0.37||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.37|-0.62|<0.0001
71651377|NCT04025684|142820727|SUPERIORITY||Adjusted Mean Change|-0.62|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.75|-0.49||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.49|-0.75|<0.0001
71651378|NCT04025684|142820727|SUPERIORITY||Adjusted Mean Change|-0.55|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.68|-0.42||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.42|-0.68|<0.0001
71762820|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.3|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.3|<0.0001
71762821|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.3|-2.0|<0.0001
71762822|NCT04518995|143027163|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.6|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.6|<0.0001
71762823|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.06|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.06|<0.0001
71762824|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.12|0.22||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.22|0.12|<0.0001
71762825|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.28|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.23|0.33||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.33|0.23|<0.0001
71762826|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.32|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.32|<0.0001
71762827|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.01||0.0006|TWO_SIDED|95.0|0.02|0.06||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.06|0.02|0.0006
71762828|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.14|0.06|<0.0001
71762829|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.15|0.23||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.23|0.15|<0.0001
71762830|NCT04518995|143027164|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.24|0.37||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.37|0.24|<0.0001
71762831|NCT04518995|143027165|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|0.3|1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.2|0.3|0.0010
71762832|NCT04518995|143027165|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.6|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.6|<0.0001
71762833|NCT04518995|143027165|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.2|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.2|<0.0001
71651379|NCT04025684|142820727|SUPERIORITY||Adjusted Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.7|-0.44||Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates.|ANCOVA|||Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.||-0.44|-0.70|<0.0001
71824994|NCT02107014|143154289|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.025
71651380|NCT01844531|142820743|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.92|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|93.529|102.52||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.520|93.529|0.0000
71703367|NCT00699751|142924109|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage decrease from baseline during the 24 week treatment|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71824995|NCT02107014|143154290|SUPERIORITY_OR_OTHER|||||||0.012|||||||Mixed Models Analysis|||||||0.012
71824996|NCT02107014|143154291|SUPERIORITY_OR_OTHER|||||||0.426|||||||Mixed Models Analysis|||||||0.426
71651381|NCT01844531|142820743|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.3|<|0.0001|TWO_SIDED|90.0|93.57|102.65||Model included effects:sequence;subjects within sequences;period and treatment with all effects as fixed.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||102.65|93.57|<.0001
71651382|NCT01844531|142820743|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.79|STANDARD_ERROR_OF_MEAN|6.7||0|TWO_SIDED|90.0|99.077|106.633||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500 , PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.||106.633|99.077|0.0000
71651383|NCT01844531|142820743|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.5|STANDARD_ERROR_OF_MEAN|6.7|<|0.0001|TWO_SIDED|90.0|98.78|106.36|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 (T2) : Empa5 + Met500 (R2), PK set AUCinfpred \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.36|98.78|<.0001
71651384|NCT01844531|142820744|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.25|STANDARD_ERROR_OF_MEAN|15.4||0.0006|TWO_SIDED|90.0|88.542|104.628|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.628|88.542|0.0006
71651385|NCT01844531|142820744|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|97.21|STANDARD_ERROR_OF_MEAN|15.1||0.0004|TWO_SIDED|90.0|89.41|105.68|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 (T1) : Empa12.5 + Met500 (R1), PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.68|89.41|0.0004
71651386|NCT01844531|142820744|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.79|STANDARD_ERROR_OF_MEAN|9.8||0|TWO_SIDED|90.0|91.772|102.093|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.093|91.772|0.0000
71651387|NCT01844531|142820744|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.91|STANDARD_ERROR_OF_MEAN|9.8|<|0.0001|TWO_SIDED|90.0|91.79|102.32|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||102.32|91.79|<.0001
71651388|NCT01844531|142820745|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.0|STANDARD_ERROR_OF_MEAN|8.5||0|TWO_SIDED|90.0|93.53|102.686|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.686|93.530|0.0000
71651389|NCT01844531|142820745|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|98.07|STANDARD_ERROR_OF_MEAN|8.5|<|0.0001|TWO_SIDED|90.0|93.55|102.81|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||102.81|93.55|<.0001
71651390|NCT01844531|142820745|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.77|STANDARD_ERROR_OF_MEAN|6.5||0|TWO_SIDED|90.0|99.146|106.522|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.522|99.146|0.0000
71824997|NCT02107014|143154292|SUPERIORITY_OR_OTHER|||||||0.042|||||||Mixed Models Analysis|||||||0.042
71824998|NCT02107014|143154293|SUPERIORITY_OR_OTHER|||||||0.708|||||||Mixed Models Analysis|||||||0.708
71824999|NCT02107014|143154294|SUPERIORITY_OR_OTHER|||||||0.558|||||||Mixed Models Analysis|||||||0.558
71825000|NCT02107014|143154295|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
71825001|NCT02107014|143154296|SUPERIORITY_OR_OTHER|||||||0.655|||||||Mixed Models Analysis|||||||0.655
71825002|NCT02107014|143154297|SUPERIORITY_OR_OTHER|||||||0.248|||||||Mixed Models Analysis|||||||0.248
71825003|NCT02107014|143154298|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|||||||0.128
71825004|NCT02107014|143154299|SUPERIORITY_OR_OTHER|||||||0.065|||||||Mixed Models Analysis|||||||0.065
71825005|NCT02107014|143154300|SUPERIORITY_OR_OTHER|||||||0.962|||||||Mixed Models Analysis|||||||0.962
71651391|NCT01844531|142820745|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.49|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|90.0|98.85|106.25|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[nmol\*h/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||106.25|98.85|<.0001
71825006|NCT02107014|143154301|SUPERIORITY_OR_OTHER|||||||0.402|||||||Mixed Models Analysis|||||||0.402
71825007|NCT02107014|143154302|SUPERIORITY_OR_OTHER|||||||0.201|||||||Mixed Models Analysis|||||||0.201
71651392|NCT01844531|142820746|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.61|STANDARD_ERROR_OF_MEAN|8.4||0|TWO_SIDED|90.0|99.882|109.555|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.555|99.882|0.0000
71825008|NCT02107014|143154303|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
71825009|NCT02107014|143154304|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71825010|NCT02107014|143154305|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71825011|NCT02107014|143154306|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
71825012|NCT02107014|143154307|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|||||||0.032
71825013|NCT02107014|143154308|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71825014|NCT02107014|143154310|SUPERIORITY_OR_OTHER|||||||0.508|||||||Mixed Models Analysis|||||||0.508
71825015|NCT02107014|143154311|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
71825016|NCT02107014|143154312|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|||||||0.326
71825017|NCT02107014|143154313|SUPERIORITY_OR_OTHER|||||||0.753|||||||Mixed Models Analysis|||||||0.753
71825018|NCT02107014|143154314|SUPERIORITY_OR_OTHER|||||||0.067|||||||Mixed Models Analysis|||||||0.067
71825019|NCT02107014|143154315|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.080
71825020|NCT02107014|143154316|SUPERIORITY_OR_OTHER|||||||0.639|||||||Mixed Models Analysis|||||||0.639
71825021|NCT02107014|143154319|SUPERIORITY_OR_OTHER|||||||0.945|||||||Mixed Models Analysis|||||||0.945
71825022|NCT02107014|143154320|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||0.038
71825023|NCT02107014|143154321|SUPERIORITY_OR_OTHER|||||||0.281|||||||Mixed Models Analysis|||||||0.281
71825024|NCT02107014|143154322|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.030
71825025|NCT02107014|143154323|SUPERIORITY_OR_OTHER|||||||0.948|||||||Mixed Models Analysis|||||||0.948
71825026|NCT02107014|143154324|SUPERIORITY_OR_OTHER|||||||0.61|||||||Mixed Models Analysis|||||||0.610
71825027|NCT02107014|143154325|SUPERIORITY_OR_OTHER|||||||0.893|||||||Mixed Models Analysis|||||||0.893
71825028|NCT02107014|143154326|SUPERIORITY_OR_OTHER|||||||0.041|||||||Mixed Models Analysis|||||||0.041
71825029|NCT02107014|143154329|SUPERIORITY_OR_OTHER|||||||0.967|||||||Mixed Models Analysis|||||||0.967
71825030|NCT02107014|143154330|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71825031|NCT02107014|143154331|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71825032|NCT04807517|143154376|OTHER|Within-group test for 16-week change|||||<|0.001|||||||Regression, Linear|Repeated measures linear regression||||||<0.001
71825033|NCT01639443|143154406|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of percentage of clinic capacity filled. We are powered to detect a 0.5 Standard Deviation (SD) difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||<0.0001
71825034|NCT01639443|143154407|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||We calculated this measure on the patient level. Our null hypothesis is that the lag time between scheduling and appointment, measured in days, will not differ between groups. We are powered to detect a 0.3 SD difference in lag time (Type I error rate = 5%; Power = 84%), accounting for the large sampling ratio (approximately 14:1).||||0.29
71825035|NCT01639443|143154408|SUPERIORITY_OR_OTHER|||||||0.49||||||We would have only expected 2 patients to be bumped in the Experimental Group, and observed 0.|Fisher Exact|||We did not explicitly power this study to detect differences in the number of service bumps, but we can compare them using Fisher's Exact Test||||0.49
71825036|NCT01639443|143154409|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||We calculated this measure on the patient level, but were hampered by a large sampling ratio (more than 50:1). Our null hypothesis is that the number of polyps detected will not differ between groups. We are powered to detect a 0.25 SD difference in polyp count per patient (Type I error rate = 5%; Power = 80%).||||0.05
71825037|NCT01639443|143154410|SUPERIORITY_OR_OTHER|||||||0.024|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of length of workday. We are powered to detect approximately 0.5 SD difference in workday length in hours (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.024
71825038|NCT01639443|143154411|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of cost per day. We are powered to detect a 0.5 SD difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."||||0.11
71825039|NCT01649427|143154412|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority||||||0.0003|||||||ANCOVA|||||||0.0003
71825040|NCT04927975|143154418|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.6||||0.304|TWO_SIDED|95.0|-22.18|6.97|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||6.97|-22.18|0.304
71825041|NCT04927975|143154418|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-21.27||||0.005|TWO_SIDED|95.0|-36.02|-6.52|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-6.52|-36.02|0.005
71825042|NCT04927975|143154418|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-19.6||||0.013|TWO_SIDED|95.0|-35.04|-4.16|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.16|-35.04|0.013
71825043|NCT04927975|143154419|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.9||||0.1|TWO_SIDED|95.0|-1.3|15.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||15.2|-1.3|0.100
71825044|NCT04927975|143154419|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|17.8||||0.002|TWO_SIDED|95.0|6.5|29.0|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||29.0|6.5|0.002
71825045|NCT04927975|143154419|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|11.7||||0.026|TWO_SIDED|95.0|1.4|21.9|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||21.9|1.4|0.026
71825046|NCT04927975|143154420|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|6.6||||0.327|TWO_SIDED|95.0|-6.6|19.7|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||19.7|-6.6|0.327
71825047|NCT04927975|143154420|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|29.3|||<|0.001|TWO_SIDED|95.0|13.8|44.9|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||44.9|13.8|<0.001
71703368|NCT00699751|142924110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.643|||<|1e-05|TWO_SIDED|95.0|0.539|0.768||Time to Prostate Specific Antigen (PSA) progression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.768|0.539|<0.00001
71703369|NCT00699751|142924111|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703370|NCT00699751|142924111|SUPERIORITY_OR_OTHER|||||||0.106||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.106
71825048|NCT04927975|143154420|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|28.7|||<|0.001|TWO_SIDED|95.0|12.6|44.7|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||44.7|12.6|<0.001
71825049|NCT04927975|143154421|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.7||||0.34|TWO_SIDED|95.0|-3.9|11.2|||Cochran-Mantel-Haenszel|||Upa 6 mg Period 1 versus Placebo Period 1||11.2|-3.9|0.340
71825050|NCT04927975|143154421|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|3.8||||0.358|TWO_SIDED|95.0|-4.3|11.8|||Cochran-Mantel-Haenszel|||Upa 11 mg Period 1 versus Placebo Period 1||11.8|-4.3|0.358
71825051|NCT04927975|143154421|SUPERIORITY|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (age group \[≤ 50 and \> 50\], baseline disease severity \[T-VASI \< 15 and ≥ 15\], and status of active vitiligo \[Yes/No\])) for the comparison of two treatment groups. The calculations at each visit were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 or non-responder imputation only if there were no missing data due to COVID-19.|Response Rate Difference|9.1||||0.027|TWO_SIDED|95.0|1.0|17.2|||Cochran-Mantel-Haenszel|||Upa 22 mg Period 1 versus Placebo Period 1||17.2|1.0|0.027
71825052|NCT04927975|143154422|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-7.45||||0.12|TWO_SIDED|95.0|-16.86|1.96|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||1.96|-16.86|0.120
71825053|NCT04927975|143154422|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-10.84||||0.026|TWO_SIDED|95.0|-20.37|-1.32|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||-1.32|-20.37|0.026
71825054|NCT04927975|143154422|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-14.27||||0.005|TWO_SIDED|95.0|-24.24|-4.3|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||-4.30|-24.24|0.005
71825055|NCT04927975|143154423|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.9||||0.545|TWO_SIDED|95.0|-8.3|4.4|||Mixed-Effect Model Repeat Measurement|||Upa 6 mg Period 1 versus Placebo Period 1||4.4|-8.3|0.545
71825056|NCT04927975|143154423|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|1.9||||0.565|TWO_SIDED|95.0|-4.5|8.3|||Mixed-Effect Model Repeat Measurement|||Upa 11 mg Period 1 versus Placebo Period 1||8.3|-4.5|0.565
71825057|NCT04927975|143154423|SUPERIORITY|Repeated measures analysis was conducted using a mixed model including observed measurements at all visits. The model included categorical fixed effects of treatment, visit and treatment-by-visit interaction, and stratification factors (age \[≤ 50 and \> 50\], Baseline disease severity \[T-VASI \< 15 and ≥ 15\], active vitiligo \[Yes/No\]) derived from actual values, and the continuous fixed covariate of Baseline measurement. An unstructured variance covariance matrix was used.|LS Mean Difference|-1.1||||0.754|TWO_SIDED|95.0|-7.8|5.6|||Mixed-Effect Model Repeat Measurement|||Upa 22 mg Period 1 versus Placebo Period 1||5.6|-7.8|0.754
71825058|NCT03722446|143154428|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71825059|NCT03722446|143154429|SUPERIORITY|||||||0.0102|||||||t-test, 1 sided|||||||0.01020
71825060|NCT03722446|143154430|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
71825061|NCT03722446|143154431|SUPERIORITY|||||||0.3753|||||||Chi-squared|||||||0.3753
71825062|NCT03722446|143154432|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
71825063|NCT03722446|143154433|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71825064|NCT01779375|143154434|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
71825065|NCT01779375|143154435|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for presentation.||||>0.05
71825066|NCT01779375|143154437|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for display.||||>0.05
71825067|NCT01743729|143154483|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.03||||0.6186|TWO_SIDED|95.0|-0.1|0.17|||ANCOVA|||||0.17|-0.10|0.6186
71825068|NCT01743729|143154484|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|12.61|||<|0.0001|TWO_SIDED|95.0|8.51|16.7|||ANCOVA|||||16.70|8.51|<0.0001
71825069|NCT01474538|143154501|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.|LS Mean difference|0.1|||||TWO_SIDED|95.0|-0.002|0.21|||Mixed Models Analysis|||||0.210|-0.002|
71825070|NCT01474538|143154502|SUPERIORITY_OR_OTHER||LS Mean difference|-0.28|||||TWO_SIDED|95.0|-2.92|2.35|||Mixed Models Analysis|||||2.35|-2.92|
71703371|NCT00699751|142924111|SUPERIORITY_OR_OTHER|||||||0.032||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.032
71825071|NCT01474538|143154503|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.94||||0.522|||||||Negative binomial|||||||0.522
71825072|NCT01474538|143154504|SUPERIORITY_OR_OTHER||LS Mean difference|-0.58||||0.216|||||||Grizzle Model|||||||0.216
71825073|NCT01474538|143154505|SUPERIORITY_OR_OTHER|||||||0.471|||||||Prescott test|||||||0.471
71825074|NCT05349864|143154525|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|120.25|||||TWO_SIDED|90.0|109.76|131.75||||||||131.75|109.76|
71825075|NCT05349864|143154526|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|116.22|||||TWO_SIDED|90.0|97.91|137.95||||||||137.95|97.91|
71825076|NCT05349864|143154527|EQUIVALENCE|Using data from Treatment A and Treatment B, natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|206.91|||||TWO_SIDED|90.0|171.14|250.15||||||||250.15|171.14|
71825077|NCT05349864|143154528|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUClast was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|135.77|||||TWO_SIDED|90.0|114.36|161.19||||||||161.19|114.36|
71825078|NCT05349864|143154529|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed AUCinf was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|138.36|||||TWO_SIDED|90.0|106.11|180.41||||||||180.41|106.11|
71703372|NCT00699751|142924112|SUPERIORITY_OR_OTHER||||||<|0.001||||||\>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703373|NCT00699751|142924112|SUPERIORITY_OR_OTHER|||||||0.002||||||\>=50% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of \>=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.002
71703374|NCT00699751|142924112|SUPERIORITY_OR_OTHER|||||||0.005||||||Confirmed PSA Response(\>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(\>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.005
71825079|NCT05349864|143154530|EQUIVALENCE|Using data from Treatment A and Treatment C, natural log transformed Cmax was analyzed using a mixed effect model with treatment and sequence as a fixed effect and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model, and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI for the ratios.|ratio of adjusted geometric means|236.58|||||TWO_SIDED|90.0|190.12|294.38||||||||294.38|190.12|
71703375|NCT00699751|142924113|SUPERIORITY_OR_OTHER|||||||0.16||||||Percentage change from baseline in PSA at Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.160
71825080|NCT00984282|143154539|SUPERIORITY_OR_OTHER||||||<|0.0001||||||stratified by age group (\< 60 years, \>= 60 years) and region (Europe, North-America, Asia)|Log Rank|||The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.||||<0.0001
71825081|NCT00984282|143154539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.454|0.758|||Regression, Cox|stratified by age group and region||||0.758|0.454|
71825082|NCT00984282|143154540|SUPERIORITY_OR_OTHER|||||||0.2892|||||||Log Rank|stratified by age group and region||||||0.2892
71825083|NCT00984282|143154540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928|||||TWO_SIDED|95.0|0.713|1.208|||Regression, Cox|stratified by age group and region||||1.208|0.713|
71825084|NCT00984282|143154541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|stratified by age group and region||||||<0.0001
71825085|NCT00984282|143154541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.557|||||TWO_SIDED|95.0|0.429|0.724|||Regression, Cox|stratified by age group and region||||0.724|0.429|
71825086|NCT00984282|143154542|SUPERIORITY_OR_OTHER||Difference of response rates|11.7||||0.0015|TWO_SIDED|95.0|3.9|19.4||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||19.4|3.9|0.0015
71825087|NCT00984282|143154543|SUPERIORITY_OR_OTHER||Difference in response rate|11.8|||<|0.0001|TWO_SIDED|95.0|7.0|16.5||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region|||16.5|7.0|<0.0001
71825088|NCT02359435|143154550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.016|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71825089|NCT01549314|143154557|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.77
71825090|NCT01549314|143154557|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.82
71825091|NCT01549314|143154558|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.64
71825092|NCT01549314|143154558|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.78
71825093|NCT01549314|143154559|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.||||0.86
71825094|NCT01549314|143154559|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.||||0.99
71825095|NCT01289119|143154565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.78|-0.37|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.37|-0.78|<0.001
71825096|NCT01289119|143154565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.51||ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates.|ANCOVA|||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.51|-0.87|<0.001
71825097|NCT01289119|143154565|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.28|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.||-0.28|-0.75|<0.001
71825098|NCT01704846|143154577|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.47|||||TWO_SIDED|90.0|95.9|105.25|||||Ratio calculated as Test product divided by reference product|||105.25|95.90|
71825099|NCT01704846|143154578|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|102.99|||||TWO_SIDED|90.0|95.57|110.98|||||Ratio calculated as Test product divided by reference product|||110.98|95.57|
71825100|NCT01704846|143154579|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.54|||||TWO_SIDED|90.0|96.1|105.18|||||Ratio calculated as Test product divided by reference product|||105.18|96.10|
71825101|NCT01704846|143154580|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.|Adjusted Mean Ratio (%)|97.66|||||TWO_SIDED|90.0|91.54|103.78|||||Ratio calculated as Test product divided by reference product|||103.78|91.54|
71825102|NCT01704846|143154581|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.34|||||TWO_SIDED|90.0|98.51|102.2|||||Ratio calculated as Test product divided by reference product|||102.20|98.51|
71825103|NCT01704846|143154582|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|99.66|||||TWO_SIDED|90.0|97.85|101.51|||||Ratio calculated as Test product divided by reference product|||101.51|97.85|
71825104|NCT01704846|143154583|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.2|||||TWO_SIDED|90.0|98.1|102.34|||||Ratio calculated as Test product divided by reference product|||102.34|98.10|
71825105|NCT00991276|143154613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.1|STANDARD_ERROR_OF_MEAN|4.38|<|0.0001|TWO_SIDED|95.0|-35.78|-18.42||This analysis was step 1 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The least squares (LS) means and standard errors (SE) were used to test for a treatment difference and construct 2-sided 95% confidence intervals (CIs). The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.42|-35.78|<0.0001
71825106|NCT00991276|143154613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.93|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-35.54|-18.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.32|-35.54|<0.0001
71825107|NCT00991276|143154613|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|4.32||0.9684|TWO_SIDED|95.0|-8.72|8.38||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.38|-8.72|0.9684
71825108|NCT00991276|143154614|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.68|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-5.44|-1.92||This analysis was step 2 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.92|-5.44|<0.0001
71825109|NCT00991276|143154614|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.88||0.1541|TWO_SIDED|95.0|-0.48|3.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.01|-0.48|0.1541
71825110|NCT00991276|143154614|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-6.68|-3.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.21|-6.68|<0.0001
71825111|NCT00991276|143154615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|30.81|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.14|45.49||This analysis was step 3 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||45.49|16.14|<0.0001
71825112|NCT00991276|143154615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.79|STANDARD_ERROR_OF_MEAN|7.34||0.0004|TWO_SIDED|95.0|12.26|41.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||41.32|12.26|0.0004
71651393|NCT01844531|142820746|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|104.53|STANDARD_ERROR_OF_MEAN|8.4|<|0.0001|TWO_SIDED|90.0|99.76|109.53|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||109.53|99.76|<.0001
71651394|NCT01844531|142820746|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.96|STANDARD_ERROR_OF_MEAN|9.2||0|TWO_SIDED|90.0|97.917|108.258|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.258|97.917|0.0000
71825113|NCT00991276|143154615|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.03|STANDARD_ERROR_OF_MEAN|7.27||0.5807|TWO_SIDED|95.0|-10.36|18.41||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.41|-10.36|0.5807
71825114|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|2.09||0.0076|TWO_SIDED|95.0|-9.8|-1.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.54|-9.80|0.0076
71825115|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.43|-6.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-6.21|-14.43|<0.0001
71825116|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.65|STANDARD_ERROR_OF_MEAN|2.06||0.0257|TWO_SIDED|95.0|0.58|8.73||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.73|0.58|0.0257
71825117|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|6.05||0.0003|TWO_SIDED|95.0|10.74|34.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||34.67|10.74|0.0003
71825118|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|6.0||0.0174|TWO_SIDED|95.0|-26.35|-2.59||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.59|-26.35|0.0174
71825119|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|37.17|STANDARD_ERROR_OF_MEAN|5.96|<|0.0001|TWO_SIDED|95.0|25.38|48.96||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||48.96|25.38|<0.0001
71825120|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.93|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|95.0|12.61|29.25||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||29.25|12.61|<0.0001
71825121|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.1|STANDARD_ERROR_OF_MEAN|4.18|<|0.0001|TWO_SIDED|95.0|23.83|40.36||This analysis was step 4 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||40.36|23.83|<0.0001
71825122|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-11.17|STANDARD_ERROR_OF_MEAN|4.14||0.008|TWO_SIDED|95.0|-19.37|-2.97||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.97|-19.37|0.0080
71886484|NCT00848354|143293350|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0021
71651395|NCT01844531|142820746|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|102.8|STANDARD_ERROR_OF_MEAN|9.2|<|0.0001|TWO_SIDED|90.0|97.72|108.14|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[nmol/L\] for EMPAGLIFLOZIN (PLASMA EDTA)||108.14|97.72|<.0001
71651396|NCT01844531|142820747|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.76|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|89.056|100.819|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.819|89.056|0.0001
71651397|NCT01844531|142820747|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|94.4|STANDARD_ERROR_OF_MEAN|11.4||0.0001|TWO_SIDED|90.0|88.64|100.54|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.54|88.64|0.0001
71651398|NCT01844531|142820747|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.83|STANDARD_ERROR_OF_MEAN|11.9||0.0002|TWO_SIDED|90.0|88.006|100.034|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.034|88.006|0.0002
71651399|NCT01844531|142820747|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|93.98|STANDARD_ERROR_OF_MEAN|12.0||0.0003|TWO_SIDED|90.0|87.94|100.43|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax \[ng/mL\] for METFORMIN (PLASMA EDTA)||100.43|87.94|0.0003
71651400|NCT01844531|142820748|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.78|STANDARD_ERROR_OF_MEAN|15.7||0.0008|TWO_SIDED|90.0|88.0|104.256|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||104.256|88.000|0.0008
71651401|NCT01844531|142820748|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.74|STANDARD_ERROR_OF_MEAN|15.5||0.0006|TWO_SIDED|90.0|88.78|105.41|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||105.41|88.78|0.0006
71651402|NCT01844531|142820748|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|95.94|STANDARD_ERROR_OF_MEAN|9.3||0|TWO_SIDED|90.0|91.199|100.934|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||100.934|91.199|0.0000
71651403|NCT01844531|142820748|SUPERIORITY_OR_OTHER||Adjusted gMean ratio FDC/single tablets|96.1|STANDARD_ERROR_OF_MEAN|9.3|<|0.0001|TWO_SIDED|90.0|91.28|101.19|||ANOVA||\*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation \[%\].|Adjusted by-treatment geometric means and relative bioavailability - analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast \[ng\*h/mL\] for METFORMIN (PLASMA EDTA)||101.19|91.28|<.0001
71825123|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|2.85||0.0834|TWO_SIDED|95.0|-10.61|0.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.67|-10.61|0.0834
71825124|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.59|STANDARD_ERROR_OF_MEAN|2.83|<|0.0001|TWO_SIDED|95.0|12.99|24.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||24.19|12.99|<0.0001
71825125|NCT00991276|143154616|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.56|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001|TWO_SIDED|95.0|-29.12|-18.01||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.01|-29.12|<0.0001
71825126|NCT00991276|143154617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.67|STANDARD_ERROR_OF_MEAN|0.99||0.0077|TWO_SIDED|95.0|-4.63|-0.72||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.72|-4.63|0.0077
71886485|NCT00848354|143293350|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||<0.0001
71703376|NCT00699751|142924114|SUPERIORITY_OR_OTHER|||||||0.004||||||Maximum Percentage Decrease from Baseline up to Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.004
71703377|NCT00699751|142924115|SUPERIORITY_OR_OTHER|||||||0.009||||||Percentage change from baseline in PSA at EOT|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||0.009
71703378|NCT00699751|142924116|SUPERIORITY_OR_OTHER||||||<|0.001||||||Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||||<0.001
71703379|NCT00699751|142924117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.00012|TWO_SIDED|95.0|0.529|0.814||Time to first Skeletal Related Event (SRE)|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.814|0.529|0.00012
71703380|NCT00699751|142924118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.639||||8e-05|TWO_SIDED|95.0|0.511|0.8||Time to External Beam Radiotherapy|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.8|0.511|0.00008
71703381|NCT00699751|142924119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.344||||0.00191|TWO_SIDED|95.0|0.17|0.695||stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||0.695|0.17|0.00191
71703382|NCT00699751|142924120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847||||0.53277|TWO_SIDED|95.0|0.504|1.426||Time to Pathological Bone Fracture|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||1.426|0.504|0.53277
71703383|NCT00699751|142924121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||0.89567|TWO_SIDED|95.0|0.435|2.07||Time to Surgical Intervention|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists||2.07|0.435|0.89567
71703384|NCT00699751|142924122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.14486|TWO_SIDED|95.0|0.404|1.145||Time to Spinal Cord Compression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||1.145|0.404|0.14486
71703385|NCT00699751|142924123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.727||||0.00932|TWO_SIDED|95.0|0.571|0.925||Time to Other Cancer Treatment|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.925|0.571|0.00932
71703386|NCT00699751|142924124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.00187|TWO_SIDED|95.0|0.546|0.873||Time to Marked Deterioration of ECOG PS|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.||0.873|0.546|0.00187
71703387|NCT04180696|142924161|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.||||||0.61|||||||Chi-squared|||||||0.61
71703388|NCT04180696|142924162|SUPERIORITY||Odds Ratio (OR)|1.192|STANDARD_ERROR_OF_MEAN|0.367||0.63|TWO_SIDED|95.0|0.579|2.455|||Regression, Logistic|Proportional odds logistic regression model. Baseline NYHA class and time included as fixed covariates.||Due to limited number of subjects with NYHA class III or IV during follow-up, class III, IV, and death were grouped as a single category for analysis.||2.455|0.579|0.63
71703389|NCT04180696|142924163|SUPERIORITY||Hazard Ratio (HR)|1.25|STANDARD_ERROR_OF_MEAN|0.476||0.64|TWO_SIDED|95.0|0.492|3.175|||Regression, Cox|Adjusted for NYHA class and sex.||||3.175|0.492|0.64
71703390|NCT04180696|142924164|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
71651404|NCT02744755|142820749|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|95.0|-0.24|0.27||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.27|-0.24|
71651405|NCT02744755|142820749|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.129|||TWO_SIDED|90.0|-0.19|0.23||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.23|-0.19|
71651406|NCT02744755|142820750|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.27|-0.11|
71651407|NCT02744755|142820750|EQUIVALENCE|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits \[0.6,-0.6\].|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.096|||TWO_SIDED|90.0|-0.08|0.24|||ANCOVA|||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.||0.24|-0.08|
71651408|NCT03173170|142820772|OTHER||Mean ratio|1.0622|||||TWO_SIDED|90.0|0.9569|1.1792||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90 percent (%) confidence intervals (CIs).||1.1792|0.9569|
71651409|NCT03173170|142820773|OTHER||Mean ratio|1.4892|||||TWO_SIDED|90.0|1.3851|1.6012||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.||1.6012|1.3851|
71651410|NCT03420768|142820798|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.13|17.7||||||||17.70|0.13|
71651411|NCT03420768|142820798|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.26|20.23||||||||20.23|0.26|
71651412|NCT00983476|142820805|SUPERIORITY_OR_OTHER||Slope|2.2||||0.11|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).|Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.11
71651413|NCT00983476|142820806|SUPERIORITY_OR_OTHER||Slope|4.02||||0.02|TWO_SIDED||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).|In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time||||0.02
71651414|NCT00983476|142820807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.32|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was not statistically significant.|||||0.32
71651415|NCT00983476|142820808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23||||0.11|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.11
71651416|NCT00983476|142820809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.47|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.47
71651417|NCT00983476|142820810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.51|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.51
71651418|NCT00983476|142820811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.83|TWO_SIDED||||||ANOVA||No comparison between groups was conducted because overall model test was NS.|||||0.83
71651419|NCT01175473|142820817|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-154.42|||<|0.0001|TWO_SIDED|95.0|-180.3|-128.54||Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System \[SAS®\] PROC MIXED procedure).|Linear fixed effects model|No alpha adjustment was performed.||To detect a difference of 100 or 150 h\*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h\*mg/dL, respectively, with a 2-sided test at 5% significance level.||-128.54|-180.30|<0.0001
71651420|NCT00588731|142820886|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.90
71651421|NCT00588731|142820887|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
71703391|NCT04180696|142924165|SUPERIORITY||Hazard Ratio (HR)|1.02|STANDARD_ERROR_OF_MEAN|0.817||0.98|TWO_SIDED|95.0|0.206|5.056|||Regression, Cox|||||5.056|0.206|0.98
71703392|NCT04739709|142924168|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703393|NCT04739709|142924169|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703394|NCT04739709|142924171|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703395|NCT04739709|142924172|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703396|NCT04739709|142924173|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703397|NCT04739709|142924174|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703398|NCT04739709|142924175|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703399|NCT04739709|142924176|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703400|NCT04739709|142924177|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71651422|NCT01684878|142820991|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.88||||0.4983|TWO_SIDED|95.0|0.62|1.27|||2 sided log-rank|||The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan vs paclitaxel), previous anti-angiogenic therapy (yes versus no), and progression-free interval (PFI) since platinum therapy (\< 3 months versus 3-6 months). A hazard ratio \< 1 favored the pertuzumab + chemotherapy treatment arm.||1.27|0.62|0.4983
71651423|NCT01684878|142820993|SUPERIORITY_OR_OTHER||Difference in response rate|6.06||||0.4102|TWO_SIDED|95.0|6.0|18.3|||Fisher Exact||Approximate 95% CI for difference of 2 rates using Hauck-Anderson method.|||18.3|6.0|0.4102
71651424|NCT01684878|142820998|SUPERIORITY_OR_OTHER||Hazard ratio (stratified)|0.9||||0.596|TWO_SIDED|95.0|0.61|1.32|||2 sided log-rank||A hazard ratio \< 1 favored the Pertuzumab + Chemotherapy treatment group|The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan versus paclitaxel), previous angiogenic therapy (yes versus no) and PFI since platinum therapy (\<3 months versus 3-6 months).||1.32|0.61|0.5960
71651425|NCT00810888|142820999|SUPERIORITY|||||||1||||||not adjusted for multiple comparisons as a prior hypothesis critical value \<0.05|Fisher Exact|||Fisher's exact test||||1.00
71651426|NCT00810888|142821000|SUPERIORITY|||||||0.66|||||||Fisher Exact|||Only the randomized subjects will be compared||||0.66
71651427|NCT00810888|142821001|SUPERIORITY||Sensitivity|38.5||||0.004|TWO_SIDED|95.0|17.6|64.6|||Fisher Exact|||||64.6|17.6|0.004
71651428|NCT00810888|142821002|SUPERIORITY||Specificity|94.2||||0.004|TWO_SIDED|95.0|85.6|98.1|||Fisher Exact|||||98.1|85.6|0.004
71651429|NCT00810888|142821003|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71651430|NCT00810888|142821004|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
71651431|NCT00810888|142821005|OTHER|A Kappa test of overall agreement was used|Kappa|0.77|||||TWO_SIDED|95.0|0.61|0.93|||||A kappa of \>0.75 is considered excellent agreement|||0.93|0.61|
71651432|NCT00810888|142821006|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||Groups 1 and 2 only the spot positive subjects randomized to interventional drug or placebo||||0.25
71651433|NCT02260258|142821114|EQUIVALENCE|Time variable log transformed and compared using linear regression controlling for shock stratification and site. Effect estimate represents geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.0||||0.82|TWO_SIDED|95.0|0.7|1.4||A priori threshold for significance 0.05|Regression, Linear|||||1.4|0.7|0.82
71651434|NCT02260258|142821115|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out all patients (N = 37 in NMB and 43 in Usual Care)|Incidence rate ratio|1.4||||0.09|TWO_SIDED|95.0|1.0|1.9|||Negative binomial regression|||All patients analyzed (N = 37 in NMB and 43 in Usual Care)||1.9|1.0|0.09
71651435|NCT02260258|142821115|EQUIVALENCE|LOS truncated at 28 days and compared using negative binomial regression controlling for stratification and site. Effect estimates represent incidence rate ratios. The parameter estimate, p value and CI provided below are from the negative binomial regression carried out on ICU survivors alone (n = 14 in NMB and 14 in Control)|Incidence rate ratio|1.3||||0.35|TWO_SIDED|95.0|0.8|2.0|||Negative binomial regression|||ICU survivors alone analyzed (n = 14 in each arm)||2.0|0.8|0.35
71703401|NCT04739709|142924178|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71651436|NCT02260258|142821116|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes all patients (n=37 in NMB and n = 43 in control). Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.3||||0.18|TWO_SIDED|95.0|0.9|1.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the full data (n= 37 in NMB and 43 in Control)||1.9|0.9|0.18
71651437|NCT02260258|142821116|EQUIVALENCE|Duration log transformed and compared using linear regression controlling for shock stratification and site. Includes patients surviving to discontinuation of mechanical ventilation (n=14 in each group). Two patients discharged from the hospital on mechanical ventilation have duration truncated at time of discharge and are considered survivors to extubation. Effect estimates represent geometric mean difference. Values above 1.0 favor longer duration in the NMB arm.|Geometric mean difference|1.4||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Linear|Duration log transformed and so parameter estimate represents geometric mean difference.||Anaysis for the patients surviving to extubation (n= 14 in both groups)||2.9|0.7|0.32
71651438|NCT02260258|142821117|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.3||||0.63|TWO_SIDED|95.0|0.5|3.3|||Regression, Logistic|||||3.3|0.5|0.63
71651439|NCT02260258|142821118|EQUIVALENCE|Comparison made using logistic regression controlling for shock stratification and site. Effect estimates represent odds ratios|Odds Ratio (OR)|1.7||||0.35|TWO_SIDED|95.0|0.6|4.7|||Regression, Logistic|||||4.7|0.6|0.35
71703402|NCT04739709|142924179|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-1.8|-1.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.3|-1.8|<0.001
71651440|NCT01610063|142821120|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison for QIDS-C16||||<0.0001
71651441|NCT01610063|142821121|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups for HAMD-17||||<0.0001
71703403|NCT04739709|142924180|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.6|-0.9|<0.001
71703404|NCT04739709|142924181|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.5|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.5|-0.8|<0.001
71825127|NCT00991276|143154617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.87|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-9.81|-5.93||This analysis was step 5 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.93|-9.81|<0.0001
71825128|NCT00991276|143154617|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.0001|TWO_SIDED|95.0|3.27|7.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.12|3.27|<0.0001
71825129|NCT00991276|143154618|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.57||0.0396|TWO_SIDED|95.0|-10.44|-0.26||This analysis was step 6 in a step-down procedure (if p-value \< 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.26|-10.44|0.0396
71651442|NCT01610063|142821122|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison for PHQ-9||||0.002
71651443|NCT01867606|142821134|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71651444|NCT01867606|142821136|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71651445|NCT02248662|142821156|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Regression, Logistic|Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.|This group is the reference group.|Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||||<0.05
71651446|NCT02248662|142821156|OTHER|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.05|||<|0.05|TWO_SIDED|95.0|0.71|1.56||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Chi-squared|||Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.||1.56|0.71|<0.05
71651447|NCT02248662|142821156|OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.27|2.84|||Chi-squared|||||2.84|1.27|<0.05
71651448|NCT03234608|142821161|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.56|TWO_SIDED|95.0|-0.44|0.81||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.81|-0.44|0.56
71651449|NCT03234608|142821162|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.79||0.73|TWO_SIDED|95.0|-1.28|1.84||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.84|-1.28|0.73
71651450|NCT03234608|142821163|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.17||0.94|TWO_SIDED|95.0|-0.35|0.33||The threshold for statistical significance was p\<0.05.|Regression, Linear|||Statistical analysis for Individual Level Healthcare Self-Efficacy Sub-scale.||0.33|-0.35|0.94
71651451|NCT03234608|142821163|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.65|TWO_SIDED|95.0|-0.33|0.52|||Regression, Linear|||Statistical analysis for Relationship-Dependent Healthcare Self-Efficacy Sub-scale||0.52|-0.33|0.65
71651452|NCT03234608|142821164|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|0.52||0.66|TWO_SIDED|95.0|-1.25|0.79||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||0.79|-1.25|0.66
71651453|NCT03234608|142821165|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.78||0.85|TWO_SIDED|95.0|-1.4|1.69||The threshold for statistical significance was p\<0.05.|Regression, Linear|||||1.69|-1.40|0.85
71651454|NCT02105701|142821169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71651455|NCT02105701|142821169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71651456|NCT02105701|142821169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71651457|NCT02105701|142821169|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate \>58%.||||<0.001
71651458|NCT02105701|142821172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71651459|NCT02105701|142821172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71651460|NCT02105701|142821172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71651461|NCT02105701|142821172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate \>58%.||||<0.001
71651462|NCT04230876|142821173|SUPERIORITY||partial eta squared|0.047|||=|0.269|TWO_SIDED|||||Within the 28 participants, changes in the COSI scores after four weeks using the Amptify were compared to the changes after four weeks watching 20 minutes of CC TV (F(1,26)=1.28).|ANOVA|||||||=0.269
71651463|NCT04230876|142821174|SUPERIORITY||partial eta squared|0.031|||=|0.401|TWO_SIDED|||||Changes in the IOI-HA scores measured after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,23)=.733).|ANOVA|||||||=0.401
71651464|NCT04230876|142821175|SUPERIORITY||partial eta squared|0.0|||=|0.968|TWO_SIDED|||||Changes in the APHAB benefit scores after four weeks using the Amptify were compared to the improvements seen after four weeks of CC TV every day (F(1,25)=.002).|ANOVA|||||||=0.968
71651465|NCT04230876|142821176|SUPERIORITY||partial eta squared|0.028|||=|0.392|TWO_SIDED|||||Changes in the SSQ-12 scores after four weeks using the Amptify were compared to the improvements seen after four weeks watching 20 minutes of CC TV (F(1,26)=.756).|ANOVA|||||||=0.392
71762834|NCT04518995|143027165|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
71762835|NCT04518995|143027166|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.3|0.5|<0.0001
71762836|NCT04518995|143027166|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|1.0|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.8|1.0|<0.0001
71762837|NCT04518995|143027166|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.0|1.0|<0.0001
71762838|NCT04518995|143027166|SUPERIORITY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.4|2.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.4|1.4|<0.0001
71762839|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.5|-1.0|< 0.0001
71762840|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.8|-1.3|< 0.0001
71762841|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-0.8|-1.2|< 0.0001
71762842|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
71762843|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-0.8|-1.3|< 0.0001
71762844|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.2|-1.7|< 0.0001
71762845|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.0|-1.5|< 0.0001
71762846|NCT04518995|143027167|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
71762847|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.17|0.34||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.34|0.17|< 0.0001
71762848|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.23|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.42|0.23|< 0.0001
71762849|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.27|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.42|0.27|< 0.0001
71762850|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.3|0.48||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.48|0.30|< 0.0001
71762851|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.26|0.42||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.42|0.26|< 0.0001
71762852|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.34|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.51|0.34|< 0.0001
71762853|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.29|0.44||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.44|0.29|< 0.0001
71825130|NCT00991276|143154618|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.55||0.0568|TWO_SIDED|95.0|-9.95|0.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.14|-9.95|0.0568
71825131|NCT00991276|143154618|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|2.52||0.8589|TWO_SIDED|95.0|-5.44|4.54||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.54|-5.44|0.8589
71825132|NCT00991276|143154619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001|TWO_SIDED|95.0|-20.26|-8.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.74|-20.26|<0.0001
71825133|NCT00991276|143154619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.35|STANDARD_ERROR_OF_MEAN|2.88||0.0001|TWO_SIDED|95.0|5.65|17.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.04|5.65|0.0001
71825134|NCT00991276|143154619|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.84|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|95.0|-31.51|-20.17||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.17|-31.51|<0.0001
71825135|NCT00991276|143154620|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.53|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-20.84|-8.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.22|-20.84|<0.0001
71825136|NCT00991276|143154620|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.42|STANDARD_ERROR_OF_MEAN|3.15|<|0.0001|TWO_SIDED|95.0|8.18|20.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||20.67|8.18|<0.0001
71825137|NCT00991276|143154620|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-35.16|-22.74||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-22.74|-35.16|<0.0001
71825138|NCT00991276|143154621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.86|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.93|-1.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.80|-3.93|<0.0001
71825139|NCT00991276|143154621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.76|-3.65||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.65|-5.76|<0.0001
71886486|NCT00848354|143293350|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71651466|NCT04230876|142821177|SUPERIORITY||partial eta squared|0.005|||=|0.72|TWO_SIDED|||||Among the 28 participants, changes in the hours per day of hearing aid usage seen after four weeks using the Amptify were compared to the changes seen after four weeks of CC TV every day (F(1,26)=.131).|ANOVA|||||||=0.720
71651467|NCT04230876|142821178|SUPERIORITY||partial eta squared|0.052|||=|0.242|TWO_SIDED|||||Changes in the NU-6 seen after four weeks using the Amptify were compared to the changes seen after four weeks watching 20 minutes of CC TV (F(1,26)=1.43).|ANOVA|||||||=0.242
71651468|NCT03200535|142821181|SUPERIORITY|Superiority analysis|||||<|0.001|||||||Chi-squared|||||||<0.001
71651469|NCT03200535|142821182|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71651470|NCT00739973|142821183|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.97|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-12.81|-7.12|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.12|-12.81|<0.001
71762854|NCT04518995|143027168|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.35|0.53||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.53|0.35|< 0.0001
71762855|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.5|-0.9|<0.0001
71762856|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.7|-1.2|<0.0001
71762857|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.6|-1.1|<0.0001
71762858|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.0|-1.4|<0.0001
71762859|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-0.8|-1.2|<0.0001
71762860|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.1|-1.6|<0.0001
71762861|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-0.8|-1.3|<0.0001
71762862|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.7|<0.0001
71762863|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.4|-0.8|<0.0001
71762864|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 12||-0.7|-1.1|<0.0001
71651471|NCT00739973|142821184|SUPERIORITY_OR_OTHER||Least Square mean Difference|-4.82|STANDARD_ERROR_OF_MEAN|1.47||0.001|TWO_SIDED|95.0|-7.7|-1.94|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.94|-7.70|0.001
71651472|NCT00739973|142821185|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.85|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-16.68|-11.0|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-11.0|-16.68|<0.001
71762865|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.5|-0.9|<0.0001
71762866|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 16||-0.8|-1.3|<0.0001
71762867|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-0.7|-1.1|<0.0001
71762868|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 20||-1.0|-1.5|<0.0001
71762869|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-0.7|-1.2|<0.0001
71825140|NCT00991276|143154621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.84|STANDARD_ERROR_OF_MEAN|0.53||0.0007|TWO_SIDED|95.0|0.79|2.89||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.89|0.79|0.0007
71825141|NCT00991276|143154622|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.45|STANDARD_ERROR_OF_MEAN|1.3||0.0617|TWO_SIDED|95.0|-5.02|0.12||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.12|-5.02|0.0617
71825142|NCT00991276|143154622|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.35|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-8.91|-3.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.80|-8.91|<0.0001
71825143|NCT00991276|143154622|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.28||0.0028|TWO_SIDED|95.0|1.37|6.44||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.44|1.37|0.0028
71825144|NCT00991276|143154623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.17|-0.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.21|-1.17|0.0056
71825145|NCT00991276|143154623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.9|-0.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.95|-1.90|<0.0001
71825146|NCT00991276|143154623|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.24||0.0026|TWO_SIDED|95.0|0.26|1.21||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.21|0.26|0.0026
71825147|NCT00991276|143154624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|95.0|-8.1|-4.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.09|-8.10|<0.0001
71825148|NCT00991276|143154624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.01||0.0029|TWO_SIDED|95.0|-5.07|-1.07||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.07|-5.07|0.0029
71825149|NCT00991276|143154624|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.03|STANDARD_ERROR_OF_MEAN|1.01||0.0032|TWO_SIDED|95.0|-5.02|-1.04||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.04|-5.02|0.0032
71825150|NCT00991276|143154626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|10.69|STANDARD_ERROR_OF_MEAN|7.71||0.1677|TWO_SIDED|95.0|-4.56|25.95||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||25.95|-4.56|0.1677
71825151|NCT00991276|143154626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.77|STANDARD_ERROR_OF_MEAN|7.63|<|0.0001|TWO_SIDED|95.0|-50.88|-20.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-20.66|-50.88|<0.0001
71825152|NCT00991276|143154626|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|46.47|STANDARD_ERROR_OF_MEAN|7.59|<|0.0001|TWO_SIDED|95.0|31.45|61.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||61.48|31.45|<0.0001
71651473|NCT00739973|142821186|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-16.04|-10.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-10.4|-16.04|<0.001
71651474|NCT00739973|142821187|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.77|-4.22|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.22|-7.77|<0.001
71651475|NCT00739973|142821188|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.91||0.001|TWO_SIDED|95.0|-4.77|-1.19|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-1.19|-4.77|0.001
71651476|NCT00739973|142821189|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.63|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-10.39|-6.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.87|-10.39|<0.001
71651477|NCT00739973|142821190|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-9.94|-6.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-6.40|-9.94|<0.001
71651478|NCT00739973|142821191|SUPERIORITY_OR_OTHER||Least Sqaure Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.92||0.011|TWO_SIDED|95.0|-4.14|-0.53|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.53|-4.14|0.011
71651479|NCT00739973|142821192|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.81|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-12.57|-9.05|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.05|-12.57|<0.001
71651480|NCT00739973|142821193|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.56|-3.03|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.03|-6.56|<0.001
71651481|NCT00739973|142821194|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.98|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|-5.78|-2.18|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-2.18|-5.78|<0.001
71651482|NCT00739973|142821195|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-11.41|-7.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-7.87|-11.41|<0.001
71651483|NCT00739973|142821196|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.26|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-8.0|-4.51|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-4.51|-8.00|<0.001
71651484|NCT00739973|142821197|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|-4.42|-0.83|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.83|-4.42|0.004
71651485|NCT00739973|142821198|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-11.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-12.85|-9.35|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-9.35|-12.85|<0.001
71651486|NCT00739973|142821199|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.83|STANDARD_ERROR_OF_MEAN|1.48||0.056|TWO_SIDED|95.0|-5.73|-0.07|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-0.07|-5.73|0.056
71703405|NCT04739709|142924182|SUPERIORITY||Mean Difference (Net)|-0.03||||0.017|TWO_SIDED|95.0|-0.06|-0.01|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.01|-0.06|0.017
71651487|NCT00739973|142821200|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-17.08|STANDARD_ERROR_OF_MEAN|1.44|<|0.001||95.0|-19.91|-14.3|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-14.3|-19.91|<0.001
71651488|NCT00739973|142821201|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.45|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-9.29|-3.62|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-3.62|-9.29|<0.001
71651489|NCT00739973|142821202|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-8.9|-3.11|||ANCOVA|A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.||||-3.11|-8.90|<0.001
71703406|NCT04739709|142924183|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.04|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.04|-0.10|<0.001
71651490|NCT00739973|142821203|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-15.03|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|-17.88|-12.2|||ANCOVA|||||-12.2|-17.88|<0.001
71703407|NCT04739709|142924184|SUPERIORITY||Mean Difference (Net)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.11|-0.06|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.06|-0.11|<0.001
71703408|NCT04739709|142924185|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703409|NCT02184156|142924193|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71703410|NCT02184156|142924194|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71703411|NCT00002874|142924195|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.02|TWO_SIDED|95.0|0.59|0.98||One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.|Log Rank||Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (\< 0.5 vs. \>= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.|||0.98|0.59|0.020
71703412|NCT00002874|142924196|SUPERIORITY||Cox Proportional Hazard|1.1||||0.289|TWO_SIDED|95.0|0.79|1.53|||Gray's test|One-sided test|||Reference level = placebo arm|1.53|0.79|0.289
71703413|NCT00002874|142924197|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.58|||Gray's test|One-sided test|Reference level = placebo arm|||0.58|0.40|<0.001
71703414|NCT00002874|142924198|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.213|TWO_SIDED|95.0|0.85|1.46|||Gray's test|One-sided test|Reference level = placebo arm|||1.46|0.85|0.213
71703415|NCT00002874|142924199|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71703416|NCT00002874|142924200|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.46|0.87|||Gray's test|One-sided test|Reference level = placebo arm|||0.87|0.46|0.002
71703417|NCT00002874|142924201|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.32|0.74|||Gray's test|One-sided test|Reference level = placebo arm|||0.74|0.32|<0.001
71703418|NCT00002874|142924202|SUPERIORITY||Cox Proportional Hazard|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.71|||Log Rank|One-side test|||Reference level = placebo arm|0.71|0.50|< 0.001
71762870|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Evenness Hair Coverage: Week 24||-1.0|-1.5|<0.0001
71703419|NCT00002874|142924203|SUPERIORITY|||||||0.06|||||||Chi-squared|||Acute radiotherapy toxicity||||0.060
71703420|NCT00002874|142924203|SUPERIORITY|||||||0.029|||||||Chi-squared|||Hormone therapy and late radiotherapy toxicity||||0.029
71703421|NCT00504309|142924211|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|Tukey p-values were used for post hoc comparisons.||Fasting triglycerides (mg/dL) were measured on two consecutive days and averaged for analysis at the end of each treatment period. The null hypothesis was that triglycerides did not differ between groups.||||0.002
71703422|NCT00504309|142924211|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||Cholesterol values were compared as the average of two fasting values at the end of each treatment. Cholesterol values included LDL-C, HDL-C, total cholesterol, and calculated ratios.||||> 0.05
71703423|NCT01271855|142924243|SUPERIORITY||Z-Score|0.93||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different pain scores. Other values would fail to reject the null hypothesis.|The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||||.35
71703424|NCT01271855|142924244|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3|TWO_SIDED|95.0|0.57|6.21|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.||6.21|0.57|.30
71703425|NCT01271855|142924245|SUPERIORITY||Z-Score|2.34||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different satisfaction scores. Other values fail to reject the null hypothesis|The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at discharge||||.02
71703426|NCT01407367|142924249|OTHER||Hazard Ratio (HR)|0.38||||0.04|TWO_SIDED|95.0|0.16|0.94||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||0.94|0.16|.04
71703427|NCT01407367|142924250|OTHER||Hazard Ratio (HR)|1.03||||0.86|TWO_SIDED|95.0|0.53|1.99||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox|||||1.99|0.53|0.86
71703428|NCT01452347|142924251|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|74.22|STANDARD_ERROR_OF_MEAN|1.05||||95.0|68.08|80.91|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||80.91|68.08|
71703429|NCT01452347|142924252|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|84.46|STANDARD_ERROR_OF_MEAN|1.11||||95.0|70.32|101.44|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||101.44|70.32|
71651491|NCT00739973|142821204|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.82|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-10.63|-5.02|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-5.02|-10.63|<0.001
71651492|NCT00739973|142821205|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|1.47||0.143|TWO_SIDED|95.0|-5.04|0.73|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||0.73|-5.04|0.143
71651493|NCT00739973|142821206|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-19.21|-13.6|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.||||-13.6|-19.21|<0.001
71651494|NCT03078478|142821214|SUPERIORITY||Treatment rate ratio|0.88||||0.1715|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|||The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.||1.06|0.73|0.1715
71651495|NCT01181531|142821230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|5.3||0.346|TWO_SIDED|95.0|-15.4|5.4||Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site|Mixed Models Analysis||Cinacalcet - Vitamin D|Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.||5.4|-15.4|0.346
71651496|NCT01181531|142821231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.11|TWO_SIDED|95.0|0.92|2.29||Stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.29|0.92|0.110
71651497|NCT01181531|142821232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.346|TWO_SIDED|95.0|0.74|2.39||stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D|||2.39|0.74|0.346
71651498|NCT00987831|142821234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|30.0||||0.2738|TWO_SIDED|95.0|5.0|95.0||Definition of Moderate Disease was \</= 3 BILAG B (moderate) organ scores, no A (severe) scores and SLEDAI \</=10. Severe disease was \> 3 BILAG B or \>/= BILAG A or SLEDAI \> 10 or meets definition for severe flare on the SELENA SLEDAI Flare Index|Log Rank|||||95|5|0.2738
71651499|NCT02339090|142821239|NON_INFERIORITY|Threshold for significance: annualized height velocity between somavaratan and daily rhGH ≤ -2.0 cm/year|LS Mean Difference|-1.28|||||TWO_SIDED|95.0|-2.32|-0.24||||||An ANCOVA model will be used to determine the adjusted (least squares) means and standard error (SE) to determine the confidence interval (CI) of the difference. ANCOVA model included treatment group, region, and gender as fixed effects; with baseline age and baseline IGF-I SDS as covariates.||-0.24|-2.32|
71651500|NCT04243096|142821250|OTHER||Mean Difference (Final Values)|4.62|||<|0.0001|TWO_SIDED|95.0|2.6|6.64|||Mixed Models Analysis|||||6.64|2.60|<0.0001
71651501|NCT04243096|142821251|OTHER||Mean Difference (Final Values)|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Mixed Models Analysis|||||-0.02|-0.06|<0.0001
71651502|NCT04243096|142821252|OTHER||Mean Difference (Final Values)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.01|||Mixed Models Analysis|||||-0.01|-0.03|<0.0001
71651503|NCT04243096|142821253|OTHER||Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.04|-0.02|||Mixed Models Analysis|||||-0.02|-0.04|<0.0001
71651504|NCT04243096|142821254|OTHER||Mean Difference (Final Values)|-0.01|||<|0.0001|TWO_SIDED|95.0|-0.01|0.0|||Mixed Models Analysis|||||0.00|-0.01|<0.0001
71651505|NCT04243096|142821255|OTHER||Mean Difference (Final Values)|-0.01||||0.0013|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0013
71651506|NCT04243096|142821256|OTHER||Mean Difference (Final Values)|-0.02||||0.0003|TWO_SIDED|95.0|-0.02|-0.01|||Mixed Models Analysis|||||-0.01|-0.02|0.0003
71651507|NCT04243096|142821257|OTHER||Mean Difference (Final Values)|0.03|||<|0.0001|TWO_SIDED|95.0|0.02|0.04|||Mixed Models Analysis|||||0.04|0.02|<0.0001
71651508|NCT04243096|142821258|OTHER||Mean Difference (Final Values)|0.09|||<|0.0001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|||||0.13|0.06|<0.0001
71651509|NCT04243096|142821262|OTHER||Mean Difference (Final Values)|9.96|||<|0.0001|TWO_SIDED|95.0|6.6|13.31|||Mixed Models Analysis|||||13.31|6.60|<0.0001
71651510|NCT04243096|142821263|OTHER||Mean Difference (Final Values)|13.07|||<|0.0001|TWO_SIDED|95.0|9.65|16.48|||Mixed Models Analysis|adjusted for age, sex, BMI, and presence of comorbidities.|Change from baseline to week 12|||16.48|9.65|<0.0001
71651511|NCT04243096|142821264|OTHER||Median Difference (Final Values)|-17.5||||0.1196|TWO_SIDED|95.0|-39.7|4.61|||Mixed Models Analysis|||||4.61|-39.7|0.1196
71651512|NCT04243096|142821266|OTHER||Mean Difference (Final Values)|0.11|||<|0.0001|TWO_SIDED|95.0|-0.04|0.25|||Mixed Models Analysis|||||0.25|-0.04|<0.0001
71651513|NCT04243096|142821267|OTHER||Mean Difference (Final Values)|-1.83|||<|0.0001|TWO_SIDED|95.0|-5.76|2.09|||Mixed Models Analysis|||||2.09|-5.76|<0.0001
71651514|NCT04243096|142821268|OTHER||Mean Difference (Final Values)|-0.15|||<|0.0001|TWO_SIDED|95.0|-0.46|0.16|||Mixed Models Analysis|||||0.16|-0.46|<0.0001
71762871|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.5|-0.9|< 0.0001
71651515|NCT04243096|142821269|OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-2.22|-0.08|||Mixed Models Analysis|||||-0.08|-2.22|<0.0001
71651516|NCT04243096|142821270|OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001|TWO_SIDED|95.0|-3.37|3.22|||Mixed Models Analysis|||||3.22|-3.37|<0.0001
71651517|NCT04243096|142821271|OTHER||Mean Difference (Final Values)|6.21||||0.0134|TWO_SIDED|95.0|1.31|11.11|||Mixed Models Analysis|||||11.11|1.31|0.0134
71651518|NCT04243096|142821272|OTHER||Median Difference (Final Values)|1.75|||<|0.0001|TWO_SIDED|95.0|1.16|2.34|||Mixed Models Analysis|||||2.34|1.16|<0.0001
71651519|NCT04243096|142821273|OTHER||Median Difference (Final Values)|-1.19||||0.003|TWO_SIDED|95.0|-1.97|-0.41|||Mixed Models Analysis|||||-0.41|-1.97|0.0030
71651520|NCT04243096|142821274|OTHER||Mean Difference (Final Values)|0.45|||<|0.0001|TWO_SIDED|95.0|0.23|0.67|||Mixed Models Analysis|||||0.67|0.23|<0.0001
71651521|NCT04243096|142821275|OTHER||Mean Difference (Final Values)|35.18|||<|0.0001|TWO_SIDED|95.0|18.7|51.67|||Mixed Models Analysis|||||51.67|18.70|<0.0001
71651522|NCT04243096|142821276|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.57|-1.39|||Mixed Models Analysis|||||-1.39|-2.57|<0.0001
71651523|NCT00810602|142821298|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|22.0|||||TWO_SIDED|95.0|13.0|36.0||||||Hypothesis: The addition of vorinostat will reduce the incidence of grade 2-4 acute graft versus host disease (GVHD) to 25% or lower by day 100.||36|13|
71651524|NCT00810602|142821300|SUPERIORITY_OR_OTHER||Percent Cumulative Incidence of GVHD|16.0|||||TWO_SIDED|95.0|8.0|30.0||||||||30|8|
71651525|NCT02792218|142821302|SUPERIORITY||rate ratio|0.495|||<|0.001|TWO_SIDED|95.0|0.375|0.655|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.655|0.375|<0.001
71651526|NCT02792218|142821303|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.863|0.500|0.003
71651527|NCT02792218|142821304|SUPERIORITY||Hazard Ratio (HR)|0.652||||0.029|TWO_SIDED|95.0|0.445|0.956|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.956|0.445|0.029
71651528|NCT02792218|142821305|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.917|0.498|0.012
71651529|NCT02792218|142821306|SUPERIORITY||Hazard Ratio (HR)|0.607||||0.022|TWO_SIDED|95.0|0.396|0.93|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||0.930|0.396|0.022
71651530|NCT02792218|142821307|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.952|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.952|0.952|0.092
71651531|NCT02792218|142821308|SUPERIORITY||Hazard Ratio (HR)|1.186||||0.516|TWO_SIDED|95.0|0.709|1.983|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2302 to address this endpoint.||1.983|0.709|0.516
71651532|NCT02792218|142821309|SUPERIORITY||rate ratio|0.025|||<|0.001|TWO_SIDED|95.0|0.013|0.049|||negative binomial regression model|||||0.049|0.013|<.001
71651533|NCT02792218|142821310|SUPERIORITY||rate ratio|0.26|||<|0.001|TWO_SIDED|95.0|0.21|0.33|||negative binomial regression model|||Month 12||0.33|0.21|<.001
71651534|NCT02792218|142821310|SUPERIORITY||rate ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.34|||negative binomial regression model|||Month 24||0.34|0.15|<.001
71651535|NCT02792218|142821310|SUPERIORITY||rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.22|||negative binomial regression model|||End of Study||0.22|0.15|<.001
71651536|NCT02792218|142821311|SUPERIORITY||Geo-mean ratio|0.93||||0.011|TWO_SIDED|95.0|0.89|0.98|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.98|0.89|0.011
71651537|NCT02792218|142821311|SUPERIORITY||Geo-mean ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.69|0.77|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.77|0.69|<.001
71651538|NCT02792218|142821311|SUPERIORITY||Geo-mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.72|0.82|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.82|0.72|<.001
71651539|NCT02792218|142821312|SUPERIORITY||Mean Difference (Net)|0.07||||0.118|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.118
71651540|NCT02792218|142821315|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||||0.847|0.486|0.002
71651541|NCT02792218|142821316|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||||0.898|0.481|0.008
71651542|NCT01745952|142821340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9819|TWO_SIDED||||||negative binomial model + overdispersion|||||||0.9819
71651543|NCT06442410|142821361|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651544|NCT06442410|142821362|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651545|NCT06442410|142821363|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71762872|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 12||-0.6|-1.1|< 0.0001
71651546|NCT06442410|142821364|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651547|NCT06442410|142821365|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651548|NCT06442410|142821366|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651549|NCT06442410|142821368|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651550|NCT06442410|142821369|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651551|NCT06442410|142821370|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS.|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651552|NCT06442410|142821371|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651553|NCT06442410|142821372|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651554|NCT06442410|142821373|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651555|NCT06442410|142821374|NON_INFERIORITY|A non-inferiority margin of 0.65 cm was selected based on a previous study of a similar therapy against traditional SCS|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71651556|NCT04947150|142821375|SUPERIORITY|||||||0.255||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA were used.||||||.255
71651557|NCT04947150|142821376|SUPERIORITY|||||||0.56||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.560
71651558|NCT04947150|142821377|SUPERIORITY|||||||0.319||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.319
71651559|NCT04947150|142821378|SUPERIORITY|||||||0.032||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.032
71651560|NCT04947150|142821379|SUPERIORITY|||||||0.044||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.044
71651561|NCT04947150|142821380|SUPERIORITY|||||||0.01||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated Measures ANOVA||||||.010
71651562|NCT04947150|142821381|SUPERIORITY|||||||0.073||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.073
71651563|NCT04947150|142821382|SUPERIORITY|||||||0.872||||||The reported p-value reflects the change across time for the full (Wave 1) sample.|ANOVA|Repeated measures ANOVA||||||.872
71651564|NCT04947150|142821383|SUPERIORITY|||||||0.145||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated Measures ANOVA||||||.145
71651565|NCT04947150|142821384|SUPERIORITY|||||||0.173||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.173
71651566|NCT04947150|142821385|SUPERIORITY|||||||0.012||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.012
71762873|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.7|-1.1|< 0.0001
71762874|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 16||-0.9|-1.4|< 0.0001
71651567|NCT04947150|142821386|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.008
71651568|NCT04947150|142821387|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
71762875|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.7|-1.1|< 0.0001
71762876|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 20||-0.9|-1.3|< 0.0001
71762877|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.8|-1.2|< 0.0001
71762878|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyebrows: Week 24||-0.9|-1.4|< 0.0001
71762879|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.3|-0.7|< 0.0001
71651569|NCT04947150|142821388|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651570|NCT04947150|142821389|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651571|NCT04947150|142821390|SUPERIORITY|||||||0.382||||||The reported p-value reflects the change across time for the full (Wave 2) sample.|ANOVA|Repeated measures ANOVA||||||.382
71651572|NCT04947150|142821391|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||<.001
71651573|NCT04947150|142821392|SUPERIORITY|||||||0.178||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.178
71651574|NCT04947150|142821393|SUPERIORITY|||||||0.081||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.081
71651575|NCT04947150|142821394|SUPERIORITY|||||||0.343||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.343
71651576|NCT04947150|142821395|SUPERIORITY|||||||0.369||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.369
71651577|NCT04947150|142821396|SUPERIORITY|||||||0.055||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.055
71651578|NCT04947150|142821399|SUPERIORITY|||||||0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.001
71762880|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 12||-0.4|-0.8|< 0.0001
71762881|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.5|-0.9|< 0.0001
71825153|NCT00991276|143154627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.73|STANDARD_ERROR_OF_MEAN|4.72||0.104|TWO_SIDED|95.0|-17.07|1.61||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.61|-17.07|0.1040
71825154|NCT00991276|143154627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|4.68||0.9325|TWO_SIDED|95.0|-9.67|8.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.87|-9.67|0.9325
71825155|NCT00991276|143154627|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|4.65||0.1175|TWO_SIDED|95.0|-16.54|1.87||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.87|-16.54|0.1175
71825156|NCT00991276|143154628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-23.98|STANDARD_ERROR_OF_MEAN|4.45|<|0.0001|TWO_SIDED|95.0|-32.78|-15.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-15.18|-32.78|<0.0001
71825157|NCT00991276|143154628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.74|STANDARD_ERROR_OF_MEAN|4.41|<|0.0001|TWO_SIDED|95.0|-33.46|-16.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-16.02|-33.46|<0.0001
71886487|NCT00848354|143293351|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||0.0062
71762882|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 16||-0.7|-1.1|< 0.0001
71762883|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-0.9|< 0.0001
71762884|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 20||-0.5|-1.0|< 0.0001
71762885|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.6|-1.1|< 0.0001
71762886|NCT04518995|143027169|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How Satisfied With Your Eyelashes: Week 24||-0.7|-1.2|< 0.0001
71762887|NCT04518995|143027170|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2489|TWO_SIDED|95.0|-0.2|0.9||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.2|0.2489
71762888|NCT04518995|143027170|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1235|TWO_SIDED|95.0|-0.1|1.1||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.1|-0.1|0.1235
71762889|NCT04518995|143027170|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9765|TWO_SIDED|95.0|-0.5|0.5||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.5|-0.5|0.9765
71762890|NCT04518995|143027170|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3559|TWO_SIDED|95.0|-0.3|0.8||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||0.8|-0.3|0.3559
71762891|NCT04518995|143027171|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.16|0.25||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.25|0.16|<0.0001
71762892|NCT04518995|143027171|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.27|0.39||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.39|0.27|<0.0001
71703430|NCT01452347|142924253|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|95.5|STANDARD_ERROR_OF_MEAN|1.05||||95.0|88.69|102.84|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||102.84|88.69|
71703431|NCT01452347|142924254|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|103.25|STANDARD_ERROR_OF_MEAN|1.11||||95.0|86.4|123.4|||ANOVA|The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.|"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both \> than the lower bound and \< than the upper bound of the acceptance range \[Note: The acceptance range for the geometric mean is 80-125%\]"||123.40|86.40|
71703432|NCT01452347|142924255|SUPERIORITY_OR_OTHER||||||<|0.001||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||<0.001
71703433|NCT01452347|142924256|SUPERIORITY_OR_OTHER|||||||0.05||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.05
71703434|NCT01452347|142924257|SUPERIORITY_OR_OTHER|||||||0.46||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.46
71703435|NCT01452347|142924258|SUPERIORITY_OR_OTHER|||||||0.65||||||Probability that P remains \< 10% are presented, where P=Percentage of patients with observed Ctrough,ss value \< 50 ng/mL|Beta Function|Probability calculated using Beta function \~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value \< 50 ng/mL), n=no. of patients evaluated||||||0.65
71703436|NCT02642679|142924269|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we had 95% power to detect an improvement of 2 points in VAS score assuming a common standard deviation of 1 point with a two sided two sample t-test each at alpha=0.17 level.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in pain. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
71703437|NCT02642679|142924270|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 80% power to detect an improvement in re-epithelialization from 14.6 days to 10 days assuming a common standard deviation of 2.9 days.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing rate. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
71703438|NCT02642679|142924271|OTHER|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 95% power to detect an improvement of 2 points in VSS score assuming a common standard deviation of 1 point.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing quality. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values \<0.05 were considered significant.|||
71825158|NCT00991276|143154628|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|4.38||0.8622|TWO_SIDED|95.0|-7.9|9.43||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.43|-7.90|0.8622
71886488|NCT00848354|143293351|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0007
71703439|NCT01112267|142924274|SUPERIORITY_OR_OTHER|||||||0.0367|||||||Cochran-Mantel-Haenszel|p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups||||||0.0367
71703440|NCT01112267|142924275|SUPERIORITY_OR_OTHER|||||||0.0095||||||p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Mann-Whitney U test|||||||0.0095
71703441|NCT01112267|142924276|SUPERIORITY_OR_OTHER|||||||0.0202||||||p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0202
71703442|NCT01112267|142924276|SUPERIORITY_OR_OTHER|||||||0.0102||||||p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.0102
71703443|NCT01112267|142924276|SUPERIORITY_OR_OTHER|||||||0.4652||||||p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared|||||||0.4652
71703444|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.3524||||||p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups|Wilcoxon (Mann-Whitney)|||||||0.3524
71762893|NCT04248491|143027189|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
71703445|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.0224||||||p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0224
71825159|NCT00991276|143154629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.87||0.08|TWO_SIDED|95.0|-7.0|0.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.40|-7.00|0.0800
71825160|NCT00991276|143154629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|1.86||0.2209|TWO_SIDED|95.0|-5.95|1.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.39|-5.95|0.2209
71651579|NCT04947150|142821400|SUPERIORITY|||||||0.079||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.079
71651580|NCT04947150|142821401|SUPERIORITY|||||||0.581||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.581
71651581|NCT04947150|142821402|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651582|NCT04947150|142821403|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651583|NCT04947150|142821404|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651584|NCT04947150|142821405|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651585|NCT04947150|142821409|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired Sample T-test||||||<.05
71651586|NCT04947150|142821411|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|Paired samples t-test||||||.006
71651587|NCT04947150|142821412|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired samples t-test||||||<.001
71651588|NCT04947150|142821413|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|Paired samples t-test||||||.220
71651589|NCT04947150|142821414|SUPERIORITY|||||||0.623|||||||t-test, 2 sided|Paired samples t-test||||||.623
71651590|NCT04947150|142821415|SUPERIORITY|||||||0.577||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.577
71651591|NCT04947150|142821416|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651592|NCT04947150|142821417|SUPERIORITY||||||<|0.001||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||<.001
71651593|NCT04947150|142821418|SUPERIORITY|||||||0.008||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.008
71651594|NCT04947150|142821419|SUPERIORITY|||||||0.601||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.601
71651595|NCT04947150|142821420|SUPERIORITY|||||||0.088||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.088
71651596|NCT04947150|142821421|SUPERIORITY|||||||0.21||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.210
71651597|NCT04947150|142821422|SUPERIORITY|||||||0.06||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.060
71651598|NCT04947150|142821423|SUPERIORITY|||||||0.37||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.370
71651599|NCT04947150|142821424|SUPERIORITY|||||||0.556||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.556
71651600|NCT04947150|142821425|SUPERIORITY|||||||0.913||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated measures ANOVA||||||.913
71651601|NCT04947150|142821426|SUPERIORITY|||||||0.241||||||The reported p-value reflects the change across time for the full sample.|ANOVA|Repeated Measures ANOVA||||||.241
71651602|NCT02449473|142821427|SUPERIORITY|The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.|Least square (LS) geometric mean ratio|1.43||||0.3862|TWO_SIDED|95.0|0.63|3.27|||ANCOVA|||Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.||3.27|0.63|0.3862
71651603|NCT02449473|142821428|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.21||||0.0546|TWO_SIDED|95.0|1.0|1.48|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.||1.48|1.00|0.0546
71703446|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.5712||||||p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.5712
71703447|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.0395||||||p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0395
71703448|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.0524||||||p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0524
71703449|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.115||||||p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.115
71825161|NCT00991276|143154629|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|1.84||0.5815|TWO_SIDED|95.0|-4.66|2.63||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.63|-4.66|0.5815
71762894|NCT04248491|143027190|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71825162|NCT00991276|143154630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.72|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|22.02|43.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||43.42|22.02|<0.0001
71762895|NCT04248491|143027192|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
71825163|NCT00991276|143154630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.86|STANDARD_ERROR_OF_MEAN|5.37|<|0.0001|TWO_SIDED|95.0|15.22|36.49||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||36.49|15.22|<0.0001
71825164|NCT00991276|143154630|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|5.33||0.2005|TWO_SIDED|95.0|-3.69|17.42||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||17.42|-3.69|0.2005
71825165|NCT00991276|143154631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.57|9.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||9.02|4.57|<0.0001
71825166|NCT00991276|143154631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.24|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|3.02|7.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||7.45|3.02|<0.0001
71825167|NCT00991276|143154631|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.56|STANDARD_ERROR_OF_MEAN|1.11||0.1622|TWO_SIDED|95.0|-0.64|3.75||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.75|-0.64|0.1622
71825168|NCT00991276|143154638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.18|-0.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.47|-1.18|<0.0001
71703450|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.7788||||||p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7788
71703451|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.7776||||||p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.7776
71762896|NCT04248491|143027194|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
71762897|NCT04248491|143027195|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||||||0.157
71762898|NCT04248491|143027196|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
71762899|NCT04248491|143027197|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
71762900|NCT04248491|143027198|SUPERIORITY|||||||0.799|||||||t-test, 2 sided|||||||0.799
71762901|NCT04248491|143027199|SUPERIORITY|||||||0.757|||||||t-test, 2 sided|||||||0.757
71762902|NCT04248491|143027200|SUPERIORITY|||||||0.472|||||||t-test, 2 sided|||||||0.472
71762903|NCT04248491|143027202|SUPERIORITY|||||||0.342|||||||t-test, 2 sided|||||||0.342
71762904|NCT02136069|143027270|SUPERIORITY||Adjusted Difference in Remission Rates|-0.9||||0.8114||95.0|-8.7|6.83|||Cochran-Mantel-Haenszel|||||6.83|-8.70|0.8114
71825169|NCT00991276|143154638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.31|-0.6||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.60|-1.31|<0.0001
71886489|NCT00848354|143293351|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71651604|NCT02449473|142821429|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.57||||0.6334|TWO_SIDED|95.0|0.06|6.0|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.||6.00|0.06|0.6334
71651605|NCT02449473|142821430|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.11||||0.3769|TWO_SIDED|95.0|0.88|1.4|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.40|0.88|0.3769
71651606|NCT02449473|142821431|SUPERIORITY|The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.49||||0.1126|TWO_SIDED|95.0|0.2|1.2|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.||1.20|0.20|0.1126
71651607|NCT04034355|142821432|SUPERIORITY||Risk Ratio (RR)|1.521||||0.028|TWO_SIDED|95.0|1.0462|2.2113|||Cochran-Mantel-Haenszel|||||2.2113|1.0462|0.0280
71651608|NCT02190279|142821444|OTHER|||||||0.0033|||||||ANOVA|||At 1 hour post injection.||||0.0033
71651609|NCT02190279|142821444|OTHER|||||||0.012|||||||ANOVA|||At 2 hour post injection.||||0.012
71651610|NCT02190279|142821445|EQUIVALENCE|One way analysis variance.|||||<|0.05|||||||variance|||||||<0.05
71651611|NCT01197417|142821483|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment||Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata||||0.24
71651612|NCT01197417|142821484|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.12
71651613|NCT01197417|142821485|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.39
71651614|NCT01197417|142821486|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||<0.01
71651615|NCT01197417|142821487|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.11
71651616|NCT01197417|142821488|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.78
71651617|NCT01197417|142821489|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.||||||0.46
71651618|NCT02070757|142821490|NON_INFERIORITY|Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.|Difference in Percentage of Participants|1.1|||||TWO_SIDED|95.0|-5.13|7.39|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||7.39|-5.13|
71651619|NCT02070757|142821491|NON_INFERIORITY|Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.|Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-6.17|8.29|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.|||8.29|-6.17|
71651620|NCT02070757|142821492|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|4.4|||||TWO_SIDED|95.0|-2.83|11.75|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||11.75|-2.83|
71703452|NCT01112267|142924277|SUPERIORITY_OR_OTHER|||||||0.0047||||||p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0047
71703453|NCT01112267|142924278|SUPERIORITY_OR_OTHER|||||||0.0527||||||p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)|||||||0.0527
71825170|NCT00991276|143154638|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4677|TWO_SIDED|95.0|-0.22|0.48||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.48|-0.22|0.4677
71762905|NCT02136069|143027271|NON_INFERIORITY|with margin -12.5%|Adjusted Difference in Remission Rates|-12.0||||0.1293|TWO_SIDED|95.0|-20.5|-3.26||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|A Farrington-Manning non-inferiority test was used to determine the nominal p-value.||||-3.26|-20.50|0.1293
71651621|NCT02070757|142821493|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.3|||||TWO_SIDED|95.0|-10.21|7.67|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||7.67|-10.21|
71651622|NCT02070757|142821494|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|7.0||||||95.0|-5.11|18.93|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||18.93|-5.11|
71651623|NCT02070757|142821496|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-1.4|||||TWO_SIDED|95.0|-6.41|3.57|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||3.57|-6.41|
71651624|NCT02070757|142821497|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|-0.8|||||TWO_SIDED|95.0|-7.67|6.04|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||6.04|-7.67|
71651625|NCT02070757|142821498|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|1.6|||||TWO_SIDED|95.0|-8.91|12.02|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||12.02|-8.91|
71651626|NCT02070757|142821499|OTHER|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\<65, \>=65) categories.|Difference in Percentage of Participants|3.3|||||TWO_SIDED|95.0|-3.38|10.44|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants||10.44|-3.38|
71651627|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rivermead Behavioural Memory Test (RBMT) - Immediate memory||||0.861
71651628|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.668||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT - Delayed memory||||0.668
71651629|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT-Delayed corrected for immediate memory||||0.713
71651630|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.028||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Short-term memory||||0.028
71651631|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.227||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Total immediate memory||||0.227
71651632|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.13||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Learning Score||||0.130
71886490|NCT00848354|143293352|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.||||<0.0001
71651633|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.106||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test- Delayed memory||||0.106
71651634|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.35||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Delayed corrected for total memory||||0.350
71651635|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.093||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Recognition||||0.093
71651636|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.614||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit Span forward - Short-term memory||||0.614
71651637|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.111||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Immediate memory||||0.111
71651638|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.451||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Delayed memory||||0.451
71651639|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.905||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time auditory response||||0.905
71651640|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.502||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time visual response||||0.502
71651641|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.531||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of omission errors||||0.531
71651642|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.681||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of commission errors||||0.681
71651643|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Reaction time for target stimuli||||0.713
71651644|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.229||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of omission errors||||0.229
71651645|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.329||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of commission errors||||0.329
71651646|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.192||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time tonic alertness||||0.192
71651647|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.164||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time phasic alertness||||0.164
71651648|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.536||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Semantic fluency||||0.536
71651649|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.572||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Phonemic fluency||||0.572
71651650|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.632||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit span backward - Working memory||||0.632
71651651|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.512||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition A||||0.512
71651652|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition B||||0.861
71651653|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.958||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Condition B/A||||0.958
71651654|NCT01546922|142821503|SUPERIORITY_OR_OTHER|||||||0.819||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Social cognition||||0.819
71651655|NCT02285634|142821544|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71651656|NCT02285634|142821544|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
71651657|NCT02285634|142821544|SUPERIORITY|||||||0.93|||||||Fisher Exact|||||||0.93
71651658|NCT02285634|142821545|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
71651659|NCT02285634|142821545|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
71651660|NCT02285634|142821545|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
71651661|NCT02285634|142821546|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
71651662|NCT02285634|142821546|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71651663|NCT02285634|142821546|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
71651664|NCT02285634|142821547|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
71651665|NCT02285634|142821547|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
71651666|NCT02285634|142821547|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71651667|NCT00880087|142821558|SUPERIORITY||Risk Difference (RD)|-2.6||||0.63|TWO_SIDED|95.0|-14.5|9.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||9.2|-14.5|0.63
71651668|NCT00880087|142821559|SUPERIORITY||Risk Difference (RD)|2.8||||0.56|TWO_SIDED|95.0|-8.0|13.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||13.7|-8.0|0.56
71651669|NCT00880087|142821560|SUPERIORITY|||||||0.7|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.70
71651670|NCT00880087|142821561|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.46
71703454|NCT01112267|142924279|SUPERIORITY_OR_OTHER|||||||0.0917||||||p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.0917
71651671|NCT01311557|142821563|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.843|1.05||||||||1.05|0.843|
71651672|NCT01311557|142821563|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.944|1.13||||||||1.13|0.944|
71651673|NCT01311557|142821563|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.928|1.18||||||||1.18|0.928|
71651674|NCT01311557|142821563|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was \> 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.|GMT Ratio|0.882|||||TWO_SIDED|95.0|0.731|1.06||||||||1.06|0.731|
71651675|NCT00572039|142821569|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.079||||0.47|TWO_SIDED|95.0|-0.14|0.29|||ANCOVA|||To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.||0.29|-0.14|.47
71651676|NCT00572039|142821570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4||||0.7|TWO_SIDED|95.0|-1.96|2.77|||ANCOVA|||To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.||2.77|-1.96|.7
71651677|NCT03478865|142821573|SUPERIORITY||Mean Difference (Final Values)|-2.54||||0.259|TWO_SIDED|95.0|-7.91|2.83||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||2.83|-7.91|0.259
71651678|NCT03478865|142821573|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.818|TWO_SIDED|95.0|-4.66|4.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||4.12|-4.66|0.818
71651679|NCT03478865|142821574|SUPERIORITY||Mean Difference (Final Values)|-3.56||||0.365|TWO_SIDED|95.0|-13.24|6.12||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||6.12|-13.24|0.365
71651680|NCT03478865|142821574|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.48|TWO_SIDED|95.0|-12.94|19.41||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the post-treatment follow-up visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||19.41|-12.94|0.480
71762906|NCT02136069|143027272|SUPERIORITY||Adjusted Difference in Remission Rates|-3.4||||0.4056|TWO_SIDED|95.0|-11.53|4.74||p-values are not multiplicity adjusted|Cochran-Mantel-Haenszel|||||4.74|-11.53|0.4056
71762907|NCT02136069|143027273|SUPERIORITY||Adjusted Difference in Remission Rates|-2.4||||0.4591|TWO_SIDED|95.0|-8.88|4.14||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.14|-8.88|0.4591
71762908|NCT02136069|143027274|SUPERIORITY||Adjusted Difference in Remission Rates|5.3||||0.4196|TWO_SIDED|95.0|-7.54|18.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||18.13|-7.54|0.4196
71651681|NCT02418455|142821587|SUPERIORITY||LS Mean|-61.0|STANDARD_ERROR_OF_MEAN|6.409|<|0.0001|TWO_SIDED|95.0|-73.56|-48.44||P-values are from generalized estimating equation (GEE) model including baseline value and visit as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||||-48.44|-73.56|< 0.0001
71651682|NCT02418455|142821595|SUPERIORITY|||||||0.2655|||||||t-test|||||||0.2655
71651683|NCT02418455|142821596|SUPERIORITY||LS Mean|-0.99|STANDARD_ERROR_OF_MEAN|0.396||0.0122|TWO_SIDED|95.0|-1.77|-0.22||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||-0.22|-1.77|0.0122
71651684|NCT02418455|142821596|SUPERIORITY||LS Mean|-1.21|STANDARD_ERROR_OF_MEAN|0.461||0.0086|TWO_SIDED|95.0|-2.12|-0.31||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||-0.31|-2.12|0.0086
71703455|NCT01112267|142924280|SUPERIORITY_OR_OTHER|||||||0.5632||||||p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared|||||||0.5632
71703456|NCT05638737|142924293|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|7.5||||0.893|TWO_SIDED|95.0|-4.1|20.5|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline ALT as covariate. Model uses log-scaled variables.||||20.5|-4.1|0.893
71703457|NCT05638737|142924294|SUPERIORITY|One-sided test where a negative change in relative to baseline is favourable|%-change in relative to base vs placebo|-0.9||||0.396|TWO_SIDED|95.0|-7.5|6.1|||Mixed Models Analysis|Participant as random effect; treatment, visit and trt:vis interaction as fixed effects; baseline Pro-C3 as covariate. Model uses log-scaled variables||||6.1|-7.5|0.396
71703458|NCT04333498|142924299|OTHER||Mean Difference (Net)|-221.03||||0.014|TWO_SIDED|95.0|-396.33|-45.73|||t-test, 2 sided|||||-45.73|-396.33|.014
71703459|NCT04333498|142924300|OTHER||Mean Difference (Net)|1103.96||||0.122|TWO_SIDED|95.0|-296.532|2502.722|||t-test, 2 sided|||||2502.722|-296.532|0.122
71703460|NCT04333498|142924301|OTHER||Mean Difference (Net)|-2.61||||0.218|TWO_SIDED|95.0|-8.614|3.391|||t-test, 2 sided|||Adherence percentage||3.391|-8.614|.218
71703461|NCT04333498|142924301|OTHER|Linear regression with generalized estimating equations (GEE)|Slope|0.046||||0.272|TWO_SIDED|95.0|-0.036|0.128|||Regression, Linear|||||0.128|-0.036|0.272
71703462|NCT01565694|142924302|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71703463|NCT01565694|142924302|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71703464|NCT01565694|142924303|OTHER|P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71825171|NCT00991276|143154639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.32|STANDARD_ERROR_OF_MEAN|5.31|<|0.0001|TWO_SIDED|95.0|-35.83|-14.8||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-14.80|-35.83|<0.0001
71703465|NCT01565694|142924304|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.029|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.029
71703466|NCT01565694|142924304|OTHER|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.026|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.026
71703467|NCT01565694|142924305|OTHER|From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Analysis of change from baseline to Week 24.||||<0.001
71703468|NCT01565694|142924306|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.006|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.||||0.006
71703469|NCT01565694|142924306|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.||||0.001
71703470|NCT01565694|142924307|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.||||0.001
71703471|NCT01565694|142924307|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.||||0.004
71703472|NCT01565694|142924308|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.003|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.003
71703473|NCT01565694|142924308|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.028|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.028
71703474|NCT01565694|142924309|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.068|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.068
71703475|NCT01565694|142924309|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.075|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.075
71703476|NCT01565694|142924310|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71703477|NCT01565694|142924310|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71703478|NCT01565694|142924311|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71703479|NCT01565694|142924311|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71703480|NCT01565694|142924312|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71703481|NCT01565694|142924312|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71703482|NCT01565694|142924313|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71762909|NCT02136069|143027275|SUPERIORITY||Adjusted Difference in Response Rates|-12.4||||0.0118|TWO_SIDED|95.0|-21.84|-2.66||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-2.66|-21.84|0.0118
71703483|NCT01565694|142924313|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71703484|NCT01565694|142924314|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.01|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.010
71703485|NCT01565694|142924314|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.004
71703486|NCT01565694|142924315|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||<0.001
71703487|NCT01565694|142924315|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||<0.001
71703488|NCT01565694|142924316|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.568|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.||||0.568
71703489|NCT01565694|142924316|OTHER|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.573|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.||||0.573
71703490|NCT06059066|142924326|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure immediately after received intradetrusor BTX-A injections||||0.57
71703491|NCT06059066|142924326|OTHER|||||||0.83||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Willingness to repeat procedure asses 6-weeks after intradetrusor BTX-A injections||||0.83
71762910|NCT02136069|143027276|SUPERIORITY||Adjusted Difference in Response Rates|-4.9||||0.2845|TWO_SIDED|95.0|-13.76|4.12||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||4.12|-13.76|0.2845
71762911|NCT02136069|143027277|SUPERIORITY||Adjusted Difference in Response Rates|-6.3||||0.1234|TWO_SIDED|95.0|-14.3|1.84||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||1.84|-14.30|0.1234
71762912|NCT02136069|143027278|SUPERIORITY||Adjusted Difference in Remission Rates|-5.0||||0.2168|TWO_SIDED|95.0|-12.84|2.94||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.94|-12.84|0.2168
71703492|NCT06059066|142924327|OTHER|||||||0.59||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total ICIQ-SF score assessed before and 6-weeks after treatment||||0.59
71703493|NCT06059066|142924327|OTHER|||||||0.29||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in ICIQ QoL score assessed before and 6-weeks after treatment||||0.29
71703494|NCT06059066|142924328|OTHER|||||||0.57||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in total NBSS-SF score assessed before and 6-weeks after treatment||||0.57
71703495|NCT06059066|142924328|OTHER|||||||0.42||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF QoL score assessed before and 6-weeks after treatment||||0.42
71703496|NCT06059066|142924328|OTHER|||||||0.24||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF incontinence domain score assessed before and 6-weeks after treatment||||0.24
71703497|NCT06059066|142924328|OTHER|||||||0.93||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF storage and voiding domain score assessed before and 6-weeks after treatment||||0.93
71703498|NCT06059066|142924328|OTHER|||||||0.64||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NBSS-SF consequences domain score assessed before and 6-weeks after treatment||||0.64
71703499|NCT06059066|142924329|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||||||0.21
71703500|NCT06059066|142924330|OTHER||||||<|2e-05||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Change in post-procedural pain as compared to baseline||||<0.00002
71703501|NCT01022580|142924337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|TWO_SIDED||||||unadj GEE|||||||0.89
71703502|NCT01022580|142924338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||unadj GEE|||||||0.33
71703503|NCT00541229|142924342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.8||||0.004||95.0|-53.1|-10.5|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 200 mg group.||-10.5|-53.1|0.004
71703504|NCT00541229|142924342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.9|||<|0.001||95.0|-63.6|-20.2|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 100 mg group.||-20.2|-63.6|<0.001
71703505|NCT00541229|142924342|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis stated that the lower bound of 80% one-sided confidence interval for the comparison in 24-hour WMG reduction between sitagliptin 200 mg and sitagliptin 100 mg is above -5 mg/dL.|Mean Difference (Final Values)|10.1||||||80.0|0.61|9999999.0|||||This is a 1-sided 80% confidence interval and the upper bound 9999999 was used here to indicate positive infinity.|This was pre-defined as a non-superiority test, i.e., to show that sitagliptin 200 mg is not superior to sitagliptin 100 mg. For this comparison, the mean in the sitagliptin 100 mg group was subtracted from the mean in the sitagliptin 200 mg group.||9999999|0.61|
71703506|NCT01807520|142924343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.7|STANDARD_ERROR_OF_MEAN|6.26|<|0.0001|TWO_SIDED|95.0|-39.1|-14.3|||Mixed model reapeated measures|||||-14.3|-39.1|<0.0001
71703507|NCT01807520|142924343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.4|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|-45.2|-23.5|||Mixed model repeated measures|||||-23.5|-45.2|<0.0001
71703508|NCT01952678|142924350|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
71651685|NCT02418455|142821596|SUPERIORITY||LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.31||0.0016|TWO_SIDED|95.0|-1.58|-0.37||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 48||-0.37|-1.58|0.0016
71651686|NCT02418455|142821596|SUPERIORITY||LS Mean|-0.57|STANDARD_ERROR_OF_MEAN|0.428||0.1792|TWO_SIDED|95.0|-1.41|0.26||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.26|-1.41|0.1792
71651687|NCT02418455|142821596|SUPERIORITY||LS Mean|-0.35|STANDARD_ERROR_OF_MEAN|0.255||0.1731|TWO_SIDED|95.0|-0.85|0.15||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.15|-0.85|0.1731
71651688|NCT02418455|142821597|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.213||0.0843|TWO_SIDED|95.0|-0.78|0.05||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12||0.05|-0.78|0.0843
71651689|NCT02418455|142821597|SUPERIORITY||LS Mean|-0.02|STANDARD_ERROR_OF_MEAN|0.513||0.9618|TWO_SIDED|95.0|-1.03|0.98||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24||0.98|-1.03|0.9618
71651690|NCT02418455|142821597|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.391||0.6954|TWO_SIDED|95.0|-0.92|0.61||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|GEE model|||Change at Week 48||0.61|-0.92|0.6954
71651691|NCT02418455|142821597|SUPERIORITY||LS Mean|0.22|STANDARD_ERROR_OF_MEAN|0.364||0.5492|TWO_SIDED|95.0|-0.5|0.93||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96||0.93|-0.50|0.5492
71651692|NCT02418455|142821597|SUPERIORITY||LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.503||0.2618|TWO_SIDED|95.0|-1.55|0.42||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144||0.42|-1.55|0.2618
71703509|NCT01952678|142924350|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.0||||0.4608|TWO_SIDED|95.0|-25.8|12.1|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.1|-25.8|0.4608
71762913|NCT02136069|143027279|SUPERIORITY||Adjusted Difference in Response Rates|-9.5||||0.0564|TWO_SIDED|95.0|-19.06|0.29||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||0.29|-19.06|0.0564
71762914|NCT02136069|143027280|SUPERIORITY||Adjusted Difference in Response Rates|-6.0||||0.1729|TWO_SIDED|95.0|-14.51|2.7||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||2.70|-14.51|0.1729
71762915|NCT02136069|143027281|SUPERIORITY||Adjusted Difference in Remission Rates|-0.8||||0.8941|TWO_SIDED|95.0|-12.01|10.68||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||10.68|-12.01|0.8941
71886491|NCT00848354|143293352|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.||||0.0073
71651693|NCT02973321|142821598|OTHER|The overall Type 1 error for multiple comparisons of the HbA1c and body weight was controlled by a Hierarchical testing procedure. Testing was performed in following sequence: 1. 1st trend test for HbA1c, 2. 1st trend test for body weight, 3. 2nd trend test for HbA1c, 4. 2nd trend test for body weight, 5. 3rd trend test for HbA1c, 6. 3rd trend test for body weight.|||||<|0.0001||||||Hierarchical testing procedure continued only, if the previous comparison was statistically significant. Threshold for significance at 0.05 level.|ANCOVA|1st trend test||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Overall 1st trend test based on a contrast with coefficients of +3, +1, -1, -3 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide. Here it is test 1 of testing order.||||< 0.0001
71651694|NCT02973321|142821598|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.956|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.359|-0.552||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Second Trend test based on a contrast with coefficients of 0, +1, 0, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 3 of hierarchical testing sequence.||-0.552|-1.359|< 0.0001
71703510|NCT01952678|142924350|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
71703511|NCT01952678|142924350|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.3|20.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.7|-17.3|1.0000
71886492|NCT00848354|143293352|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.||||<0.0001
71703512|NCT01952678|142924351|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
71703513|NCT01952678|142924351|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.1||||0.4599|TWO_SIDED|95.0|-26.1|12.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.2|-26.1|0.4599
71703514|NCT01952678|142924351|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
71703515|NCT01952678|142924351|EQUIVALENCE|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|TWO_SIDED|95.0|-17.5|20.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.9|-17.5|1.0000
71703516|NCT01952678|142924352|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.0|22.0|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.0|-22.0|1.0000
71703517|NCT01952678|142924352|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.4||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
71703518|NCT01952678|142924352|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-2.0||||1|TWO_SIDED|95.0|-23.0|18.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||18.5|-23.0|1.0000
71703519|NCT01952678|142924352|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.3||||1|TWO_SIDED|95.0|-20.8|20.8|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||20.8|-20.8|1.0000
71703520|NCT01952678|142924353|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-22.8|22.8|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||22.8|-22.8|1.0000
71762916|NCT02136069|143027290|SUPERIORITY|Week 10|Difference in Adjusted Means|-3.1||||0.4106|TWO_SIDED|95.0|-10.6|4.3||p-value has not been adjusted for multiplicity|ANCOVA|||||4.3|-10.6|0.4106
71762917|NCT02136069|143027290|SUPERIORITY|Week 30|Difference in Adjusted Means|-5.7||||0.1434|TWO_SIDED|95.0|-13.3|1.9||p-value has not been adjusted for multiplicity|ANCOVA|||||1.9|-13.3|0.1434
71762918|NCT02136069|143027290|SUPERIORITY|Week 54|Difference in Adjusted Means|-6.1||||0.1103|TWO_SIDED|95.0|-13.6|1.4||p-value has not been adjusted for multiplicity|ANCOVA|||||1.4|-13.6|0.1103
71762919|NCT03328208|143027298|SUPERIORITY||Mean Difference (Final Values)|0.724|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71703521|NCT01952678|142924353|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|5.2||||0.5187|TWO_SIDED|95.0|-16.7|26.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||26.2|-16.7|0.5187
71703522|NCT01952678|142924353|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-21.5|21.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||21.5|-21.5|1.0000
71703523|NCT01952678|142924353|EQUIVALENCE|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.7||||0.7123|TWO_SIDED|95.0|-19.1|23.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||23.9|-19.1|0.7123
71703524|NCT01952678|142924354|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.3|15.3|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.3|-13.3|1.0000
71703525|NCT01952678|142924354|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-3.8||||0.5731|TWO_SIDED|95.0|-17.7|9.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||9.8|-17.7|0.5731
71703526|NCT01952678|142924354|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.1||||1|TWO_SIDED|95.0|-13.8|13.8|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||13.8|-13.8|1.0000
71703527|NCT01952678|142924354|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.834|TWO_SIDED|95.0|-12.8|14.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||14.7|-12.8|0.8340
71703528|NCT01952678|142924355|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|TWO_SIDED|95.0|-13.5|15.6|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.6|-13.5|1.0000
71703529|NCT01952678|142924355|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-1.9||||0.8429|TWO_SIDED|95.0|-16.1|12.0|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||12.0|-16.1|0.8429
71703530|NCT01952678|142924355|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.8214|TWO_SIDED|95.0|-13.0|15.0|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||15.0|-13.0|0.8214
71651695|NCT02973321|142821598|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-0.854|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001|TWO_SIDED|95.0|-1.264|-0.444||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Visit 4 (Day 1) BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline HbA1c as a covariate. Third Trend test based on a contrast with coefficients of 0, 0, +1, -1 and 0 for SAR425899 0.20 mg, 0.16 mg, 0.12 mg, placebo and liraglutide, respectively. Here, it is test no. 5 of hierarchical testing sequence.||-0.444|-1.264|< 0.0001
71651696|NCT02973321|142821599|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.||||||0.0012||||||Threshold for significance at 0.05 level.|ANCOVA|1st Trend test||Placebo, SAR425899 0.12,0.16,0.20 mg: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 2 of hierarchical testing sequence.||||0.0012
71651697|NCT02973321|142821599|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant|LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|0.887|<|0.0001|TWO_SIDED|95.0|-5.309|-1.832||Threshold for significance at 0.05 level.|ANCOVA|2nd Trend test||SAR425899 0.16 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 4 of hierarchical testing sequence.||-1.832|-5.309|< 0.0001
71651698|NCT02973321|142821599|OTHER|Hierarchical testing procedure continued only, if the previous comparison was statistically significant.|LS Mean difference|-2.517|STANDARD_ERROR_OF_MEAN|0.891||0.0047|TWO_SIDED|95.0|-4.264|-0.77||Threshold for significance at 0.05 level.|ANCOVA|3rd Trend test||3rd Trend Test: SAR425899 0.12 mg vs Placebo: Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c value (\<8, \>=8 %), randomization strata of Day 1 BMI (\<35.0 kg/m\^2, \>=35.0 kg/m\^2), and country as fixed effects and baseline body weight as a covariate. Here, it is test no. 6 of hierarchical testing sequence.||-0.77|-4.264|0.0047
71651699|NCT04458467|142821712|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
71651700|NCT04458467|142821713|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71651701|NCT00346164|142821806|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
71651702|NCT00346164|142821807|OTHER|||||||0.0049|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0049
71651703|NCT00346164|142821808|OTHER||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
71651704|NCT00346164|142821809|OTHER|||||||0.0096|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.||||0.0096
71651705|NCT00346164|142821810|OTHER||||||<|0.0001|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.||||<0.0001
71651706|NCT00346164|142821811|OTHER|||||||0.0228|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .||||0.0228
71651707|NCT00346164|142821813|OTHER||Kappa statistic|0.82|||||TWO_SIDED|95.0|0.76|0.88||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.88|0.76|
71651708|NCT00346164|142821814|OTHER||Kappa statistic|0.42|||||TWO_SIDED|95.0|0.36|0.48||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.||0.48|0.36|
71651709|NCT01998243|142821829|SUPERIORITY||Risk Ratio (RR)|1.2||||0.689|TWO_SIDED|95.0|0.53|2.6|||Chi-squared||risk ratio (RR)|||2.60|0.53|0.689
71762920|NCT03328208|143027299|SUPERIORITY||Mean Difference (Final Values)|0.038|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71762921|NCT01667419|143027306|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.001|TWO_SIDED|95.0|0.37|0.78|||Log Rank|||||0.78|0.37|0.0010
71651710|NCT01998243|142821830|SUPERIORITY||Risk Ratio (RR)|1.59||||0.144|TWO_SIDED|95.0|0.84|3.01|||Chi-squared||all in all balloon and postsurgical morbidity in group A vs. group B.|||3.01|0.84|0.144
71703531|NCT01952678|142924355|EQUIVALENCE|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.2||||0.6577|TWO_SIDED|95.0|-12.0|16.1|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants||16.1|-12.0|0.6577
71703532|NCT00421733|142924371|SUPERIORITY_OR_OTHER|||||||0.071||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.071
71703533|NCT00421733|142924371|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.||||||0.229
71703534|NCT00421733|142924371|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.||||||0.053
71703535|NCT00421733|142924372|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Fisher Exact|||||||0.102
71703536|NCT00421733|142924372|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher Exact|||||||0.038
71703537|NCT00421733|142924373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.855|TWO_SIDED|95.0|-0.26|0.22|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||0.22|-0.26|0.855
71703538|NCT00421733|142924373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.009|TWO_SIDED|95.0|-0.57|-0.08|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction||||-0.08|-0.57|0.009
71703539|NCT00421733|142924374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
71762922|NCT01667419|143027306|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2598|TWO_SIDED|95.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.2598
71703540|NCT00421733|142924374|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.||||||<0.001
71762923|NCT01667419|143027307|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0133|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||||0.90|0.37|0.0133
71762924|NCT01667419|143027307|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6815|TWO_SIDED|95.0|0.57|1.44|||Log Rank|||||1.44|0.57|0.6815
71762925|NCT01667419|143027308|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0274|TWO_SIDED|95.0|0.3|0.94|||Log Rank|||||.94|0.30|0.0274
71762926|NCT01667419|143027308|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8597|TWO_SIDED|95.0|0.55|1.66|||Log Rank|||||1.66|0.55|0.8597
71762927|NCT03364270|143027312|OTHER||Mean Difference (Final Values)|0.58||||0.001|TWO_SIDED|95.0|0.33|0.84||Threshold p\<0.05|t-test, 2 sided|||Null hypothesis: There is no difference in mean 18F-RGD uptake (expressed as a target to background ratio) in the culprit artery (carotid artery implicated in stroke or transient ischemic attack \[TIA\]) when compared to mean 18F-RGD uptake in the contralateral carotid artery. A paired t-test was used to compare 18F-RGD uptake in culprit plaque to plaque in the contralateral artery.||0.84|0.33|.001
71703541|NCT02265744|142924375|SUPERIORITY|||||||0.9745|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9745
71703542|NCT02265744|142924375|SUPERIORITY|||||||0.6217|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.6217
71703543|NCT02265744|142924375|SUPERIORITY|||||||0.8295|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.8295
71703544|NCT02265744|142924375|SUPERIORITY|||||||0.9439|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.||||||0.9439
71703545|NCT00299221|142924413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.4||0.44||95.0|||||t-test, 2 sided|||comparing ISHLT biopsy score between groups at 1 year||||0.44
71703546|NCT01086475|142924417|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
71703547|NCT01086475|142924418|SUPERIORITY_OR_OTHER|||||||0.927|||||||Chi-squared|||||||0.927
71703548|NCT01086475|142924419|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||t-test, 2 sided|||||||0.048
71703549|NCT00505362|142924420|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71703550|NCT00505362|142924421|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
71703551|NCT01004393|142924429|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||ANOVA|||||||0.161
71703552|NCT04999020|142924435|SUPERIORITY||Difference in response rates|-15.38||||0.4192|TWO_SIDED|80.0|-38.55|8.48|||Barnard's unconditional exact test|||||8.48|-38.55|0.4192
71703553|NCT02448043|142924451|SUPERIORITY|||||||0.532||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.532
71703554|NCT02448043|142924452|SUPERIORITY|||||||0.523||||||Threshold is p\<0.05|t-test, 2 sided|||||||0.523
71703555|NCT02448043|142924453|SUPERIORITY|||||||0.912||||||Threshold is p\<0.05|t-test, 2 sided|||Comparing baseline values of both arms to completion values of both arms||||0.912
71703556|NCT02448043|142924454|SUPERIORITY|||||||0.062||||||Threshold is p\<0.05|t-test, 2 sided|||Comparison between baseline nail brittleness values and completion values||||0.062
71703557|NCT01835756|142924492|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED||||||t-test, 2 sided|||||||<0.00001
71703558|NCT01835756|142924493|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71762928|NCT02910986|143027330|SUPERIORITY||||||>|0.05|||||||Chi-squared|||The percentage with improved knowledge (defined as having an incorrect response at T0 and a correct response at T1) was compared between study groups with chi-square tests.||||> 0.05
71762929|NCT02910986|143027331|SUPERIORITY|||||||0.56||||||The priori threshold for statistical significance was 0.05|Chi-squared|||||||0.56
71762930|NCT02910986|143027332|SUPERIORITY||||||>|0.05||||||The priori threshold for statistical significance was 0.05.|Chi-squared|||||||> 0.05
71762931|NCT02910986|143027332|OTHER||difference between EC and UC|2.6|||||TWO_SIDED|98.3|-6.0|11.2||||||||11.2|-6.0|
71762932|NCT02910986|143027332|OTHER||difference between INT and UC|5.0|||||TWO_SIDED|98.3|-4.3|14.3||||||||14.3|-4.3|
71762933|NCT02910986|143027332|OTHER||difference between INT and ENH|2.4|||||TWO_SIDED|98.3|-7.0|11.9||||||||11.9|-7.0|
71762934|NCT04380519|143027339|SUPERIORITY||Risk Ratio (RR)|1.012||||0.434|ONE_SIDED|97.5|0.88|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.880|0.434
71762935|NCT04380519|143027339|SUPERIORITY||Risk Ratio (RR)|1.125||||0.073|ONE_SIDED|97.5|0.989|||Hochberg adjustment was applied for p-values|Maximal Likelihood Estimator (MLE) model||||||0.989|0.073
71762936|NCT04380519|143027341|SUPERIORITY||Risk Ratio (RR)|1.019||||0.393|ONE_SIDED|97.5|0.892|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.892|0.393
71651711|NCT01998243|142821831|SUPERIORITY|||||||0.937|||||||Wilcoxon (Mann-Whitney)|||||||0.937
71762937|NCT04380519|143027341|SUPERIORITY||Risk Ratio (RR)|1.098||||0.061|ONE_SIDED|97.5|0.975|||unadjusted|Maximal Likelihood Estimator (MLE) model||||||0.975|0.061
71762938|NCT04380519|143027342|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.31|1.44||||||||1.44|0.31|
71762939|NCT04380519|143027342|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.12|0.89||||||||0.89|0.12|
71762940|NCT04380519|143027342|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.28|1.49||||||||1.49|0.28|
71762941|NCT04380519|143027342|SUPERIORITY||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.11|0.87||||||||0.87|0.11|
71762942|NCT04380519|143027343|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.93|5.92||||||||5.92|0.93|
71762943|NCT04380519|143027343|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.55|4.09||||||||4.09|0.55|
71762944|NCT04380519|143027343|SUPERIORITY||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.94|6.81||||||||6.81|0.94|
71762945|NCT04380519|143027343|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.53|4.46||||||||4.46|0.53|
71762946|NCT01727024|143027346|SUPERIORITY_OR_OTHER|||||||0.451|||||||Generalized Estimating Equation (GEE)|||||||0.451
71651712|NCT01998243|142821832|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71651713|NCT01998243|142821833|SUPERIORITY|||||||0.673|||||||Fisher Exact|||||||0.673
71651714|NCT04569786|142821839|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|0.92||||0.649|TWO_SIDED|90.0|0.63|1.34||1-sided|Longitudinal data analysis (LDA) method|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.34|0.63|0.649
71651715|NCT04569786|142821839|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.0||||0.495||90.0|0.68|1.48||1-sided|LDA model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.48|0.68|0.495
71651716|NCT04569786|142821839|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|1.1||||0.339|TWO_SIDED|90.0|0.75|1.6||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||1.60|0.75|0.339
71651717|NCT04569786|142821839|SUPERIORITY|A conclusion of superiority is based on the lower limit of the 90% CI for the estimated GMT ratio (V590/Placebo) being \>1.0 (one-sided p-value \<0.05).|GMT Ratio|2.26|||<|0.001|TWO_SIDED|90.0|1.56|3.28||1-sided|LDA Model|GMT ratios and 90% CIs, and p-values are estimated from an LDA model and are provided in accordance with the statistical analysis plan.||||3.28|1.56|<0.001
71651718|NCT02563769|142821874|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71651719|NCT02563769|142821874|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71651720|NCT03069417|142821947|SUPERIORITY|Conducted at post-treatment time point.||||||0.11|||||||Mixed Models Analysis|||||||0.11
71651721|NCT03069417|142821947|SUPERIORITY|Conducted at 3-month follow-up time point.||||||0.56|||||||Mixed Models Analysis|||||||0.56
71651722|NCT03069417|142821948|SUPERIORITY|Main effect for time calculated at 3-month follow-up time point.|Fixed effects coefficient (β)|-12.7|||<|0.05|TWO_SIDED|95.0|-22.29|-3.15||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.15|-22.29|< 0.05
71651723|NCT03069417|142821949|SUPERIORITY|Interaction evaluated at post-treatment time point.|Fixed effects coefficient (β)|-11.1|||<|0.005|TWO_SIDED|95.0|-18.41|-3.83||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.83|-18.41|< 0.005
71651724|NCT03069417|142821949|SUPERIORITY|Main effect for time at 3-month follow-up time point.|Fixed effects coefficient (β)|-13.8|||<|0.005|TWO_SIDED|95.0|-22.5|-5.17||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-5.17|-22.50|< 0.005
71651725|NCT03069417|142821951|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|-10.1|||<|0.05|TWO_SIDED|95.0|-19.58|-0.67||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-0.67|-19.58|< 0.05
71651726|NCT03069417|142821951|SUPERIORITY|Main effect for time at post-treatment time point.|Fixed effects coefficient (β)|-12.8|||<|0.01|TWO_SIDED|95.0|-22.14|-3.37||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||-3.37|-22.14|< 0.01
71651727|NCT03069417|142821952|SUPERIORITY|Main effect for condition.|Fixed effects coefficient (β)|6.2|||<|0.05|TWO_SIDED|95.0|0.5|11.88||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||||11.88|0.50|< 0.05
71651728|NCT04117945|142821953|SUPERIORITY|||||||0.8874|||||||One-sided unstratified log-rank|||||||0.8874
71651729|NCT04117945|142821954|SUPERIORITY|||||||0.9683|||||||One-sided unstratified log-rank|||||||0.9683
71651730|NCT04117945|142821955|SUPERIORITY|||||||0.0448|||||||One-sided unstratified log-rank|||||||0.0448
71651731|NCT04117945|142821956|SUPERIORITY|||||||0.9007|||||||One-sided unstratified log-rank|||||||0.9007
71651732|NCT01917968|142821969|SUPERIORITY||Adjusted difference in percentages|6.5||||0.056|TWO_SIDED|90.0|-0.2|13.2||Statistical significance is considered at 0.05 level.|Z statistics|P-value is calculated using a Z statistics from the propensity score adjusted estimates. Missing values are handled using multiple imputation.||||13.2|-0.2|0.056
71651733|NCT01917968|142821970|NON_INFERIORITY|With type I error of 0.05 and type II error of 0.20 (power 80%), 298 subjects (149 subjects per arm) are needed to detect non-inferiority with a margin of 10%.|Adjusted difference in percentages|-0.4|||||TWO_SIDED|90.0|-2.7|1.9|||||The propensity score adjusted difference in SAE rate of Uphold LITE transvaginal mesh (TVM) vs. NTR was estimated.|||1.9|-2.7|
71651734|NCT02148445|142821983|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%.||||||0.88|||||||Chi-squared|||||||0.88
71651735|NCT02148445|142821984|SUPERIORITY|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. This sample size will provide comparable power for looking at 6 month sustained cessation.||||||0.55|||||||Chi-squared|||||||0.55
71651736|NCT02148445|142821985|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
71651737|NCT02148445|142821986|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71651738|NCT02148445|142821987|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71651739|NCT02148445|142821988|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||||||0.39
71651740|NCT02148445|142821989|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
71651741|NCT02148445|142821990|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
71651742|NCT02148445|142821991|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
71703559|NCT03501277|142924497|EQUIVALENCE|Alogliptin: For each analyte, an analysis of variance (ANOVA) was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative bioavailability (BA) determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90 percent (%) confidence interval (CI) for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|Least Square Mean (LSM) difference|1.0706||||0.014|TWO_SIDED|90.0|1.023|1.1204|||ANOVA|||||1.1204|1.0230|0.014
71651743|NCT02148445|142821993|SUPERIORITY|||||||0.08|||||||Chi-squared|||Month 3 self-reported abstinence||||0.08
71651744|NCT02148445|142821993|SUPERIORITY|||||||0.06|||||||Chi-squared|||Month 3 biochemically verified abstinence||||0.06
71651745|NCT02148445|142821993|SUPERIORITY|||||||0.22|||||||Chi-squared|||Month 6, self-reported abstinence||||0.22
71651746|NCT02148445|142821993|SUPERIORITY|||||||0.34|||||||Chi-squared|||Month 6, biochemically verified abstinence||||0.34
71651747|NCT02148445|142821993|SUPERIORITY|||||||0.66|||||||Chi-squared|||Month 12, self-reported abstinence||||0.66
71651748|NCT02148445|142821994|SUPERIORITY|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
71651749|NCT02148445|142821995|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71651750|NCT02148445|142821996|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71651751|NCT02148445|142821997|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
71651752|NCT02148445|142821998|SUPERIORITY|||||||0.0918|||||||Mixed Models Analysis|||||||0.0918
71651753|NCT03450629|142821999|EQUIVALENCE|8 AM +/- 30 min||||||0.0006|||||||t-test, 2 sided|||||||0.0006
71651754|NCT03450629|142821999|EQUIVALENCE|10 AM +/- 30 min||||||0.0291|||||||t-test, 2 sided|||||||0.0291
71651755|NCT03450629|142821999|EQUIVALENCE|4 PM +/- 30 min||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71651756|NCT00749411|142822038|NON_INFERIORITY|GSK233705/GW642444 were declared non-inferior to placebo for heart rate if the upper limit of the 95% confidence interval for the estimated treatment difference for weighted mean heart rate was less than +10bpm.|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-5.5|3.5|||||Analysis performed using a Repeated Measures Model with covariates of baseline pulse rate, sex, age, smoking status, treatment and Day and Day by treatment and Day by baseline interactions.|||3.5|-5.5|
71651757|NCT04052698|142822044|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1645|||<|0.0001|TWO_SIDED|95.0|0.10194|0.26558|||Regression, Linear|||||0.26558|0.10194|<0.0001
71651758|NCT04052698|142822046|NON_INFERIORITY|1-sided test where the mean ratio is less than 0.5 utilizing a negative binomial counting regression model. One-sided alpha level of 2.5%.|Mean Difference (Final Values)|0.1389|||<|0.0001|TWO_SIDED|95.0|0.07664|0.25187|||Regression, Linear|||||0.25187|0.07664|<0.0001
71651759|NCT02756637|142822058|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.98|1.11||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.11|0.98|
71651760|NCT02756637|142822058|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.9|1.14||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.||1.14|0.90|
71651761|NCT03581188|142822085|SUPERIORITY||Odds Ratio (OR)|3.5|||||TWO_SIDED|95.0|0.9|14.0||||||Odds ratios report differences between groups at follow-up.||14|0.9|
71651762|NCT03581188|142822086|SUPERIORITY||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.8|5.7||||||||5.7|0.8|
71651763|NCT03581188|142822088|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|1.1|2.1||||||||2.1|1.1|
71651764|NCT03581188|142822089|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.6|2.0||||||||2|0.6|
71651765|NCT03581188|142822090|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-2.0|23.0||||||For new melanoma diagnoses, we calculated the difference in proportions and confidence intervals using the χ2 method without continuity correction. We included baseline measurement of the outcome in the models as a covariate to estimate between group difference in change from baseline.||23|-2|
71651766|NCT03581188|142822091|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|2.0|19.0||||||New melanoma diagnoses prompted at unscheduled visit||19|2|
71651767|NCT03581188|142822091|SUPERIORITY||Risk Ratio (RR)|0.0|||||TWO_SIDED|95.0|-9.0|10.0||||||New melanoma diagnoses prompted at scheduled visit||10|-9|
71651768|NCT03581188|142822092|SUPERIORITY||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-5.8|3.0||||||||3|-5.8|
71651769|NCT01316419|142822129|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean SBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
71651770|NCT01316419|142822132|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Mean DBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||<0.0001
71651771|NCT01316419|142822134|SUPERIORITY_OR_OTHER|||||||0.1099|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.1099
71651772|NCT01316419|142822135|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0197
71651773|NCT01316419|142822136|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.4543
71825172|NCT00991276|143154639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.45|STANDARD_ERROR_OF_MEAN|5.27|<|0.0001|TWO_SIDED|95.0|-38.89|-18.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-18.02|-38.89|<0.0001
71825173|NCT00991276|143154639|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|5.19||0.5461|TWO_SIDED|95.0|-7.13|13.4||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||13.40|-7.13|0.5461
71825174|NCT00991276|143154640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.04|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|0.63|1.45||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.45|0.63|<0.0001
71825175|NCT00991276|143154640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.65|1.46||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.46|0.65|<0.0001
71825176|NCT00991276|143154640|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9403|TWO_SIDED|95.0|-0.42|0.39||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.39|-0.42|0.9403
71825177|NCT00991276|143154641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.58|STANDARD_ERROR_OF_MEAN|3.26||0.0215|TWO_SIDED|95.0|-14.03|-1.14||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.14|-14.03|0.0215
71825178|NCT00991276|143154641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.23||0.5569|TWO_SIDED|95.0|-4.49|8.29||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.29|-4.49|0.5569
71825179|NCT00991276|143154641|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.48|STANDARD_ERROR_OF_MEAN|3.2||0.0036|TWO_SIDED|95.0|-15.81|-3.16||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-3.16|-15.81|0.0036
71825180|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.8||0.6947|TWO_SIDED|95.0|-2.85|4.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.27|-2.85|0.6947
71825181|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|1.79||0.398|TWO_SIDED|95.0|-5.06|2.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.02|-5.06|0.3980
71825182|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|1.78||0.2144|TWO_SIDED|95.0|-1.3|5.76||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.76|-1.30|0.2144
71825183|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|14.17|STANDARD_ERROR_OF_MEAN|4.0||0.0006|TWO_SIDED|95.0|6.25|22.08||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||22.08|6.25|0.0006
71825184|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.07|STANDARD_ERROR_OF_MEAN|3.97||0.0061|TWO_SIDED|95.0|3.22|18.92||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||18.92|3.22|0.0061
71825185|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.95||0.4342|TWO_SIDED|95.0|-4.72|10.93||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||10.93|-4.72|0.4342
71825186|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.07||0.242|TWO_SIDED|95.0|-6.53|1.66||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.66|-6.53|0.2420
71651774|NCT01316419|142822137|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0152
71651775|NCT01316419|142822138|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test|||||||0.0013
71651776|NCT01316419|142822139|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The change of QOL data collected using the EQ VAS is analyzed by paired t-test|Paired t test|||||||<0.0001
71651777|NCT01316419|142822141|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.0006
71651778|NCT01316419|142822142|SUPERIORITY_OR_OTHER|||||||0.4248|TWO_SIDED|||||Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.4248
71651779|NCT01316419|142822143|SUPERIORITY_OR_OTHER|||||||0.5579|TWO_SIDED|||||Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test|Paired t test|||||||0.5579
71651780|NCT01316419|142822144|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test|Paired t-test|||||||0.0006
71703560|NCT03501277|142924497|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0276||||0.326|TWO_SIDED|90.0|0.9817|1.0757|||ANOVA|||||1.0757|0.9817|0.326
71651781|NCT00455962|142822149|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||Using previously collected data from a group of 18 predominantly Caucasian women undergoing a similar infusion we determined that 22 women would be necessary to identify a 30% difference in peak LH levels, the primary outcome measure, between AAW and CW with 80% power at a significance level of 0.05.||||0.69
71651782|NCT04039919|142822160|OTHER||Geometric LS Mean ratio|0.785|||||TWO_SIDED|90.0|0.6513|0.9461||||||The log-transformed PK parameters was analyzed by a mixed analysis of variance (ANOVA) with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9461|0.6513|
71651783|NCT04039919|142822161|OTHER||Geometric LS Mean Ratio|0.8342|||||TWO_SIDED|90.0|0.6999|0.9942||||||The log-transformed PK parameters was analyzed by a mixed ANOVA with period and treatment as fixed effects and study participant as the random effect. The estimates and confidence intervals are back-transformed after the analysis.||0.9942|0.6999|
71651784|NCT01652729|142822201|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2167||0.001|TWO_SIDED|95.0|-1.15|-0.3|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.30|-1.15|0.0010
71651785|NCT01652729|142822201|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1638||0.0209|TWO_SIDED|95.0|-0.7|-0.06|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.06|-0.70|0.0209
71651786|NCT01652729|142822201|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2278||0.1347|TWO_SIDED|95.0|-0.79|0.11|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.11|-0.79|0.1347
71651787|NCT01652729|142822202|SUPERIORITY_OR_OTHER|||||||0.0489|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0489
71651788|NCT01652729|142822202|SUPERIORITY_OR_OTHER|||||||0.0103|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c \<7% at Week 28.||||0.0103
71651789|NCT01652729|142822203|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|5.96||0.0924|TWO_SIDED|95.0|-21.8|1.7|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||1.7|-21.8|0.0924
71651790|NCT01652729|142822203|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|8.037||0.0001|TWO_SIDED|95.0|-46.7|-15.1|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-15.1|-46.7|0.0001
71651791|NCT01652729|142822204|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4058||0.8625|TWO_SIDED|95.0|-0.73|0.87||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||0.87|-0.73|0.8625
71651792|NCT01652729|142822204|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.5419||0.0198|TWO_SIDED|95.0|-2.34|-0.2||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (\<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.||||-0.20|-2.34|0.0198
71651793|NCT01652729|142822205|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.96|STANDARD_ERROR_OF_MEAN|15.71||0.0248|TWO_SIDED|95.0|-67.23|-4.68||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||-4.68|-67.23|0.0248
71651794|NCT01652729|142822205|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.89|STANDARD_ERROR_OF_MEAN|19.66||0.2914|TWO_SIDED|95.0|-60.02|18.25||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (\< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.||||18.25|-60.02|0.2914
71651795|NCT00483548|142822206|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.36|STANDARD_ERROR_OF_MEAN|1.37||0.7921||95.0|-3.07|2.34||Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.|ANCOVA Mixed-effects repeated-measures|No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.|Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to \[≤\] 0.0076) or futility (nominal 2-sided p-value greater than or equal to \[≥\] 0.5099).||2.34|-3.07|0.7921
71651796|NCT00483548|142822207|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.7223||95.0|-0.25|0.36|||ANCOVA Mixed-effects repeated-measures|||Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.||0.36|-0.25|0.7223
71651797|NCT00483548|142822208|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.846||||0.5029||95.0|0.52|1.38|||Regression, Logistic||Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.38|0.52|0.5029
71651798|NCT00483548|142822209|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.949||||0.8266||95.0|0.59|1.52|||Regression, Logistic||Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value \> 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.52|0.59|0.8266
71651799|NCT00483548|142822210|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.939||||0.7924||95.0|0.59|1.5||Logistic regression model with treatment, country, and type of mood stabilizer.|Regression, Logistic|||Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.||1.50|0.59|0.7924
71651800|NCT00483548|142822211|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.68|STANDARD_ERROR_OF_MEAN|0.89||0.0594||95.0|-3.42|0.07|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-3.42|0.0594
71651801|NCT00483548|142822211|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.25|STANDARD_ERROR_OF_MEAN|1.03||0.223||95.0|-3.27|0.77|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.77|-3.27|0.2230
71651802|NCT00483548|142822211|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|1.09||0.6971||95.0|-2.57|1.72|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.72|-2.57|0.6971
71651803|NCT00483548|142822211|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.68|STANDARD_ERROR_OF_MEAN|1.12||0.5485||95.0|-2.89|1.54|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.54|-2.89|0.5485
71651804|NCT00483548|142822211|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.25|STANDARD_ERROR_OF_MEAN|1.19||0.8322||95.0|-2.6|2.1|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.10|-2.60|0.8322
71651805|NCT00483548|142822212|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1771||95.0|-0.29|0.05|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.29|0.1771
71651806|NCT00483548|142822212|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1765||95.0|-0.37|0.07|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.07|-0.37|0.1765
71651807|NCT00483548|142822212|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6765||95.0|-0.27|0.18|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.27|0.6765
71651808|NCT00483548|142822212|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.977||95.0|-0.24|0.25|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.25|-0.24|0.9770
71825187|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|2.05||0.981|TWO_SIDED|95.0|-4.12|4.02||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||4.02|-4.12|0.9810
71651809|NCT00483548|142822212|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7907||95.0|-0.3|0.23|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|-0.30|0.7907
71651810|NCT00483548|142822213|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0392||95.0|-0.43|-0.01|||ANOVA|||Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||-0.01|-0.43|0.0392
71651811|NCT00483548|142822213|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2803||95.0|-0.38|0.11|||ANOVA|||Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.11|-0.38|0.2803
71651812|NCT00483548|142822213|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9835||95.0|-0.26|0.26|||ANOVA|||Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.26|-0.26|0.9835
71651813|NCT00483548|142822213|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7062||95.0|-0.34|0.23|||ANOVA|||Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.23|-0.34|0.7062
71651814|NCT00483548|142822213|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9518||95.0|-0.31|0.29|||ANOVA|||Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.||0.29|-0.31|0.9518
71651815|NCT00483548|142822213|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.4757||95.0|-0.2|0.42||Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|ANOVA|||Week 6; LOCF||0.42|-0.20|0.4757
71651816|NCT00483548|142822214|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.35|STANDARD_ERROR_OF_MEAN|0.75||0.6362||95.0|-1.12|1.82|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.82|-1.12|0.6362
71651817|NCT00483548|142822214|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.59|STANDARD_ERROR_OF_MEAN|0.8||0.4565||95.0|-0.98|2.17|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.17|-0.98|0.4565
71651818|NCT00483548|142822214|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.61|STANDARD_ERROR_OF_MEAN|0.86||0.477||95.0|-1.08|2.3|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||2.30|-1.08|0.4770
71651819|NCT00483548|142822215|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1277||95.0|-0.2|1.6|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.60|-0.20|0.1277
71651820|NCT00483548|142822215|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.64|STANDARD_ERROR_OF_MEAN|0.53||0.2345||95.0|-0.41|1.68|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.68|-0.41|0.2345
71651821|NCT00483548|142822215|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.13|STANDARD_ERROR_OF_MEAN|0.6||0.8337||95.0|-1.05|1.3|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.30|-1.05|0.8337
71651822|NCT00483548|142822215|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.43|STANDARD_ERROR_OF_MEAN|0.59||0.4646||95.0|-0.73|1.59|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.59|-0.73|0.4646
71651823|NCT00483548|142822215|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.3993||95.0|-0.67|1.67|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.67|-0.67|0.3993
71651824|NCT00483548|142822215|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.19|STANDARD_ERROR_OF_MEAN|0.65||0.7647||95.0|-1.08|1.46|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||1.46|-1.08|0.7647
71651825|NCT00483548|142822216|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|4.24|STANDARD_ERROR_OF_MEAN|1.65||0.0108||95.0|0.99|7.5|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||7.50|0.99|0.0108
71651826|NCT00483548|142822217|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-4.56|STANDARD_ERROR_OF_MEAN|1.35||0.001||95.0|-7.24|-1.87|||ANCOVA|||Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||-1.87|-7.24|0.0010
71651827|NCT00483548|142822218|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.44|STANDARD_ERROR_OF_MEAN|0.28||0.123|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.12|-1.00|0.1230
71651828|NCT00483548|142822218|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.34||0.6232|TWO_SIDED|95.0|-0.84|0.5|||ANCOVA|||Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.50|-0.84|0.6232
71651829|NCT00483548|142822219|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0096||95.0|0.04|0.31|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.31|0.04|0.0096
71825188|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.05||0.2468|TWO_SIDED|95.0|-6.44|1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.67|-6.44|0.2468
71651830|NCT00483548|142822219|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.8134||95.0|-0.13|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.13|0.8134
71651831|NCT00483548|142822219|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0226||95.0|0.02|0.29|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.29|0.02|0.0226
71651832|NCT00483548|142822220|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0193||95.0|0.02|0.23|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.23|0.02|0.0193
71651833|NCT00483548|142822220|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4745||0.16|-0.07|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.16|-0.07|0.4745
71651834|NCT00483548|142822220|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.07|STANDARD_ERROR_OF_MEAN|0.06||0.2613||95.0|-0.05|0.19|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.19|-0.05|0.2613
71651835|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0271||95.0|0.01|0.21|||ANCOVA|||Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.21|0.01|0.0271
71651836|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7462||95.0|-0.07|0.05|||ANCOVA|||Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.07|0.7462
71651837|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.9574||95.0|-0.08|0.08|||ANCOVA|||Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.08|-0.08|0.9574
71651838|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0844||95.0|-0.01|0.1|||ANCOVA|||Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.10|-0.01|0.0844
71651839|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.5779||95.0|-0.04|0.06|||ANCOVA|||Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.04|0.5779
71651840|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7455||95.0|-0.05|0.06|||ANCOVA|||Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.06|-0.05|0.7455
71651841|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3278||95.0|-0.02|0.05|||ANCOVA|||Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.05|-0.02|0.3278
71651842|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9097||95.0|-0.03|0.03|||ANCOVA|||Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.03|-0.03|0.9097
71651843|NCT00483548|142822221|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9864||95.0|-0.04|0.04|||ANCOVA|||Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.04|-0.04|0.9864
71651844|NCT00483548|142822222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.52|STANDARD_ERROR_OF_MEAN|2.54||0.5519||95.0|-3.5|6.53|||ANCOVA|||Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||6.53|-3.50|0.5519
71651845|NCT00483548|142822222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.5238||95.0|-0.35|0.18|||ANCOVA|||Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.18|-0.35|0.5238
71651846|NCT00483548|142822222|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|0.09|STANDARD_ERROR_OF_MEAN|0.14||0.536||95.0|-0.19|0.36|||ANCOVA|||Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.||0.36|-0.19|0.5360
71651847|NCT03852524|142822266|SUPERIORITY||Median Difference (Net)|11.0||||0.81|TWO_SIDED||||||Log Rank|||The sample size (41 patients per study group; 82 patients total) for this superiority trial was calculated with a power of 90% (alpha = 0.05) and based on the assumption that 50% of subjects in the placebo group would experience a bowel movement by postoperative day 3, as compared to 85% in the treatment group. Additionally, a 10% lost-to-follow up rate was assumed.||||0.81
71651848|NCT01557920|142822304|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||pathological swallows under anesthesia vs. wakefulness: 25.9% vs. 4.9%|Mixed Models Analysis|||||||0.001
71651849|NCT01557920|142822304|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Comparison of pathological swallow-rate increase by carbon-dioxide during anesthesia and wakefulness||||<0.001
71651850|NCT01557920|142822309|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The number of swallows per hour: 1.7±3.3 during anesthesia vs. 28.0±22.3 during wakefulness|Mixed Models Analysis|||||||<0.001
71651851|NCT01439724|142822337|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.158||||0.05|TWO_SIDED|95.0|0.05|0.498|||Chi-squared|||The primary end point of the study was the incidence of grade 3-4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.||0.498|0.050|0.05
71651852|NCT01040793|142822340|SUPERIORITY_OR_OTHER||Ratio to placebo|1.118|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|1.043|1.199|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.199|1.043|0.0018
71703561|NCT03501277|142924497|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM diiference|0.9594||||0.405|TWO_SIDED|90.0|0.8837|1.0415|||ANOVA|||||1.0415|0.8837|0.405
71703562|NCT03501277|142924497|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|0.9257||||0.124|TWO_SIDED|90.0|0.8523|1.0053|||ANOVA|||||1.0053|0.8523|0.124
71703563|NCT03501277|142924498|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0157||||0.081|TWO_SIDED|90.0|1.0009|1.0308|||ANOVA|||||1.0308|1.0009|0.081
71703564|NCT03501277|142924498|EQUIVALENCE|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0009||||0.922|TWO_SIDED|90.0|0.9862|1.0158|||ANOVA|||||1.0158|0.9862|0.922
71703565|NCT03501277|142924498|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0486||||0.066|TWO_SIDED|90.0|1.0051|1.0939|||ANOVA|||||1.0939|1.0051|0.066
71703566|NCT03501277|142924498|EQUIVALENCE|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0267||||0.308|TWO_SIDED|90.0|0.9839|1.0714|||ANOVA|||||1.0714|0.9839|0.308
71703567|NCT01327703|142924499|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.|Treatment difference|-2.08||||0.459|TWO_SIDED|95.0|-7.23|4.02||As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Mixed Models Analysis|||Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.||4.02|-7.23|0.4590
71886493|NCT04202679|143293360|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0216|TWO_SIDED|95.0|1.08|5.0||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05.||5.00|1.08|0.0216
71703568|NCT00849472|142924541|SUPERIORITY_OR_OTHER||Percentage of participants|17.98|||||TWO_SIDED|95.0|10.64|27.55|||||The estimated value (EV) represents the percentage of participants with pCR. Participants with missing data were excluded from the denominator (n=89; 4 participants with missing data) for the calculation of the EV.|||27.55|10.64|
71703569|NCT01257438|142924555|SUPERIORITY_OR_OTHER||Greenwood's estimate of variance|0.59|||<|0.001|TWO_SIDED|95.0|0.44|0.79|||Log Rank|||Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).||0.79|0.44|<0.001
71703570|NCT01257438|142924556|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).||||||0.007|TWO_SIDED||||||Farrington and Manning Exact Test|The non-inferiority margin is 0.075 (or 7.5%)||||||0.007
71703571|NCT00963508|142924584|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71703572|NCT00963508|142924585|SUPERIORITY_OR_OTHER|||||||0.0005|||||||t-test, 2 sided|||||||0.0005
71651853|NCT01040793|142822340|SUPERIORITY_OR_OTHER||Ratio to placebo|1.105|STANDARD_ERROR_OF_MEAN|0.039||0.0052||95.0|1.03|1.184|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.184|1.030|0.0052
71651854|NCT01040793|142822341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.035||0.0155||95.0|0.016|0.152|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.152|0.016|0.0155
71703573|NCT01181479|142924589|EQUIVALENCE|Comparison of AG200-15 and Lessina for cycles 1-6.||||||0.067|||||||Chi-squared|||||||0.067
71703574|NCT00433290|142924632|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
71703575|NCT00433290|142924632|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
71703576|NCT00433290|142924632|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment\*Visit, Baseline\*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.||||<0.001
71703577|NCT00433290|142924633|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||ANCOVA|Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.||||||0.164
71703578|NCT00433290|142924634|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline (change = endpoint - baseline)|ANCOVA|Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.016
71703579|NCT00433290|142924635|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.068
71703580|NCT00433290|142924636|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.064
71703581|NCT00433290|142924637|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.008
71703582|NCT00433290|142924637|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.047
71703583|NCT00433290|142924638|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.009
71703584|NCT00433290|142924639|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71703585|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.897
71703586|NCT00433290|142924640|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||<0.001
71703587|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.004
71703588|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for General Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.051
71703589|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.508
71703590|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.019
71703591|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.415
71703592|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.006
71703593|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.342
71703594|NCT00433290|142924640|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.||||||0.135
71703595|NCT00433290|142924641|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.||||||0.209
71703596|NCT00433290|142924642|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value for Change from Baseline. Change = Week 13 value minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.871
71703597|NCT00433290|142924643|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.||||||0.138
71703598|NCT00433290|142924644|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.003
71825189|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.32||0.1496|TWO_SIDED|95.0|-0.17|1.09||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.09|-0.17|0.1496
71703599|NCT00433290|142924645|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.015
71825190|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.31||0.8184|TWO_SIDED|95.0|-0.69|0.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.55|-0.69|0.8184
71703600|NCT00433290|142924646|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||<0.001
71703601|NCT00433290|142924646|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.|Regression, Linear|||Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1\*treatment group+a2\*change in BDI total+a3\*change in HADS-A+a4\*BL of BPI average pain+a5\*BL of BDI total+a6\*BL of HADS-A.||||0.002
71703602|NCT00433290|142924647|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Change from Baseline. Change=Endpoint minus baseline.|ANCOVA|||||||0.007
71703603|NCT00433290|142924648|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.050
71703604|NCT00433290|142924649|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.913
71703605|NCT00433290|142924650|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.066
71703606|NCT00433290|142924651|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.001
71703607|NCT00433290|142924652|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.260
71703608|NCT00433290|142924653|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.489
71703609|NCT00433290|142924654|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.131
71703610|NCT00433290|142924655|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|||||||0.082
71703611|NCT00433290|142924657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
71703612|NCT00433290|142924657|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for AST Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.010
71703613|NCT00433290|142924657|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for GGT Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.023
71703614|NCT00433290|142924658|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.042
71703615|NCT00433290|142924659|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.005
71703616|NCT00433290|142924660|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value for SBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.285
71703617|NCT00433290|142924660|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for DBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||0.668
71703618|NCT00433290|142924661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
71703619|NCT00433290|142924662|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||||||0.040
71703620|NCT03837938|142924670|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%.|Difference in rates Levopront®-Libexin®|5.81|||||ONE_SIDED|97.5|-7.17|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.17|
71703621|NCT03837938|142924671|NON_INFERIORITY|According to the protocol and SAP non-inferiority margin was defined as 20%|difference in rates Levopront®-Libexin®|5.43|||||ONE_SIDED|97.5|-7.31|||||||Difference in daytime resolved rates Levopront® (Test) vs Libexin® (Control) was reported|||-7.31|
71703622|NCT03837938|142924672|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||>|0.999|||||||Fisher Exact|||||||>0.999
71703623|NCT03837938|142924673|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||=|0.861|||||||Fisher Exact|||||||=0.861
71703624|NCT03837938|142924674|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 2, Day 4||||<0.001
71703625|NCT03837938|142924674|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 2 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Daytime at Visit 3, Day 8||||<0.001
71703626|NCT03837938|142924674|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nightime at Visit 2, Day 4||||<0.001
71703627|NCT03837938|142924674|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Nighttime at Visit 3, Day 8||||<0.001
71703628|NCT03837938|142924675|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||Visit 2, Day 4||||<0.001
71703629|NCT03837938|142924675|NON_INFERIORITY|non-inferiority margin was defined as 20%|||||<|0.001|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||at Visit 3, Day 8||||<0.001
71703630|NCT03837938|142924676|NON_INFERIORITY|non-inferiority margin is defined as 20%|||||=|0.336|||||||t-test, 1 sided|Between groups change was tested using two sample t-test (normal data) or Mann-Whitney test (violation of normality).||||||=0.336
71703631|NCT01917773|142924678|NON_INFERIORITY_OR_EQUIVALENCE|"Reported MIs and SDs in healthy volunteers from an adult study were used to calculate sample size (1). A sample size of 13 patients was deemed adequate to detect a 25% change in MI with 80% power.~Reference: Rao SS, Kavelock R, Beaty J, Ackerson K, et al. Effects of fat and carbohydrate meals on colonic motor response. Gut. Feb 2000;46(2):205-211."||||||0.087|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P \<0.05.||||0.087
71703632|NCT01917773|142924678|SUPERIORITY_OR_OTHER|||||||0.552|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P \<0.05.||||0.552
71703633|NCT01917773|142924678|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P \<0.05.||||0.807
71703634|NCT00308685|142924692|OTHER||Difference in adjusted means|5.163||||0.0002|TWO_SIDED|95.0|2.478|7.847||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) with baseline FEV1 as covariate and fixed effects of pooled center and treatment group.||7.847|2.478|0.0002
71703635|NCT03345095|142924696|SUPERIORITY||Mean Difference (Net)|-6.4||||0.0004|TWO_SIDED|95.0|-8.6|-2.5|||Wilcoxon (Mann-Whitney)|||||-2.5|-8.6|0.0004
71703636|NCT03345095|142924697|SUPERIORITY||Mean Difference (Net)|-0.55||||0.15|TWO_SIDED|95.0|-1.27|0.16|||Wilcoxon (Mann-Whitney)|||||0.16|-1.27|0.15
71703637|NCT01121575|142924728|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|69.25|||||TWO_SIDED|90.0|54.22|88.44|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||88.44|54.22|
71703638|NCT01121575|142924729|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|78.84|||||TWO_SIDED|90.0|58.9|105.54|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUC10 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC10 was based on data from 6 participants. No statistical analysis was performed for PF-06260182.||105.54|58.90|
71825191|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0918|TWO_SIDED|95.0|-0.09|1.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.15|-0.09|0.0918
71703639|NCT01121575|142924731|SUPERIORITY_OR_OTHER||Ration of adjust geometric mean|70.6|||||TWO_SIDED|90.0|54.71|91.12|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 11 participants. No statistical analysis was performed for PF-06260182.||91.12|54.71|
71703640|NCT01121575|142924734|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|117.81|||||TWO_SIDED|90.0|64.97|213.61|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||213.61|64.97|
71703641|NCT01121575|142924735|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|121.9|||||TWO_SIDED|90.0|70.2|211.66|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUC24 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC24 was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||211.66|70.20|
71703642|NCT01121575|142924737|SUPERIORITY_OR_OTHER||Ratio of adjust geometric mean|130.57|||||TWO_SIDED|90.0|82.46|206.73|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 3 participants. No statistical analysis was performed for PF-05199265.||206.73|82.46|
71703643|NCT03158311|142924740|NON_INFERIORITY|Non-inferiority margin: 0.25 points|Least Square mean (LS Mean)|-0.038|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.139|||P-Value is one-sided|Mixed Model for Repeated Measures (MMRM)||||||-0.139|<0.001
71703644|NCT03158311|142924740|NON_INFERIORITY|Non-inferiority margin: 0.25 points|LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|ONE_SIDED|97.5|-0.027|||P-Value is one-sided|MMRM||||||-0.027|<0.001
71703645|NCT03158311|142924741|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.025||0.892|TWO_SIDED|95.0|-0.046|0.052||P-value is two-sided|MMRM|||Week 8||0.052|-0.046|0.892
71703646|NCT03158311|142924741|SUPERIORITY||LS Mean|0.067|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.115||P-value is two-sided|MMRM|||Week 8||0.115|0.018|0.007
71703647|NCT03158311|142924741|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.945|TWO_SIDED|95.0|-0.05|0.047||P-value is two-sided|MMRM|||Week 16||0.047|-0.050|0.945
71703648|NCT03158311|142924741|SUPERIORITY||LS Mean|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.007|TWO_SIDED|95.0|0.018|0.114||P-value is two-sided|MMRM|||Week 16||0.114|0.018|0.007
71703649|NCT03158311|142924741|SUPERIORITY||LS Mean|0.009|STANDARD_ERROR_OF_MEAN|0.026||0.713|TWO_SIDED|95.0|-0.041|0.06||P-value is two-sided|MMRM|||Week 24||0.060|-0.041|0.713
71703650|NCT03158311|142924741|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.026|<|0.001|TWO_SIDED|95.0|0.046|0.146||P-value is two-sided|MMRM|||Week 24||0.146|0.046|<0.001
71703651|NCT03158311|142924742|SUPERIORITY||LS Mean|-0.023|STANDARD_ERROR_OF_MEAN|0.046||0.308|TWO_SIDED|95.0|-0.113|0.067||P-value is one-sided|MMRM|||Week 16||0.067|-0.113|0.308
71703652|NCT03158311|142924742|SUPERIORITY||LS Mean|-0.079|STANDARD_ERROR_OF_MEAN|0.046||0.044|TWO_SIDED|95.0|-0.169|0.012||P-value is one-sided|MMRM|||Week 16||0.012|-0.169|0.044
71703653|NCT03158311|142924742|SUPERIORITY||LS Mean|-0.032|STANDARD_ERROR_OF_MEAN|0.047||0.245|TWO_SIDED|95.0|-0.125|0.06||P-value is one sided|MMRM|||Week 24||0.060|-0.125|0.245
71703654|NCT03158311|142924742|SUPERIORITY||LS Mean|-0.124|STANDARD_ERROR_OF_MEAN|0.047||0.004|TWO_SIDED|95.0|-0.216|-0.032||P-value is one sided|MMRM|||Week 24||-0.032|-0.216|0.004
71703655|NCT03158311|142924743|SUPERIORITY||LS Mean|0.018|STANDARD_ERROR_OF_MEAN|0.049||0.719|TWO_SIDED|95.0|-0.079|0.115||P-value is two-sided|MMRM|||||0.115|-0.079|0.719
71886494|NCT04202679|143293361|SUPERIORITY||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.56|22.66||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.66|3.56|<0.0001
71703656|NCT03158311|142924743|SUPERIORITY||LS Mean|0.082|STANDARD_ERROR_OF_MEAN|0.049||0.097|TWO_SIDED|95.0|-0.015|0.179||P-value is two-sided|MMRM|||||0.179|-0.015|0.097
71703657|NCT03158311|142924744|SUPERIORITY||Odds Ratio (OR)|1.23||||0.061|TWO_SIDED|95.0|0.94|1.61||P-value is one sided|Regression, Logistic|Logistic Regression Model via Generalized estimating equations (GEE)||||1.61|0.94|0.061
71703658|NCT03158311|142924744|SUPERIORITY||Odds Ratio (OR)|1.11||||0.227|TWO_SIDED|95.0|0.85|1.46||P-value is one-sided|Regression, Logistic|Logistic Regression Model via GEE||||1.46|0.85|0.227
71703659|NCT03158311|142924745|SUPERIORITY||Odds Ratio (OR)|1.17||||0.108|TWO_SIDED|95.0|0.91|1.49||P-value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.49|0.91|0.108
71703660|NCT03158311|142924745|SUPERIORITY||Odds Ratio (OR)|1.33||||0.013|TWO_SIDED|95.0|1.03|1.7||P-Value is one sided|Regression, Logistic|Logistic regression model via the GEE||||1.70|1.03|0.013
71703661|NCT03158311|142924746|SUPERIORITY||LS Mean|-0.003|STANDARD_ERROR_OF_MEAN|0.027||0.908|TWO_SIDED|95.0|-0.055|0.049||P-Value is two-sided|MMRM|||Week 8||0.049|-0.055|0.908
71703662|NCT03158311|142924746|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.026||0.046|TWO_SIDED|95.0|0.001|0.104||P-Value is two-sided|MMRM|||Week 8||0.104|0.001|0.046
71703663|NCT03158311|142924746|SUPERIORITY||LS Mean|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.87|TWO_SIDED|95.0|-0.047|0.056||P-Value is two-sided|MMRM|||Week 16||0.056|-0.047|0.870
71703664|NCT03158311|142924746|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.026||0.028|TWO_SIDED|95.0|0.006|0.109||P-Value is two-sided|MMRM|||Week 16||0.109|0.006|0.028
71703665|NCT03158311|142924746|SUPERIORITY||LS Mean|0.028|STANDARD_ERROR_OF_MEAN|0.028||0.303|TWO_SIDED|95.0|-0.026|0.083||P-Value is two-sided|MMRM|||Week 24||0.083|-0.026|0.303
71703666|NCT03158311|142924746|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.027|<|0.001|TWO_SIDED|95.0|0.041|0.148||P-Value is two-sided|MMRM|||Week 24||0.148|0.041|<0.001
71703667|NCT03158311|142924747|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.563|TWO_SIDED|95.0|-0.048|0.087||P-value is two-sided|MMRM|||Week 8||0.087|-0.048|0.563
71703668|NCT03158311|142924747|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.034||0.068|TWO_SIDED|95.0|-0.005|0.129||P-Value is two-sided|MMRM|||Week 8||0.129|-0.005|0.068
71703669|NCT03158311|142924747|SUPERIORITY||LS Mean|-0.007|STANDARD_ERROR_OF_MEAN|0.035||0.844|TWO_SIDED|95.0|-0.076|0.062||P-Value is two-sided|MMRM|||Week 16||0.062|-0.076|0.844
71703670|NCT03158311|142924747|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.035||0.097|TWO_SIDED|95.0|-0.01|0.125||P-Value is two-sided|MMRM|||Week 16||0.125|-0.010|0.097
71703671|NCT03158311|142924747|SUPERIORITY||LS Mean|0.003|STANDARD_ERROR_OF_MEAN|0.036||0.927|TWO_SIDED|95.0|-0.067|0.074||P-Value is two-sided|MMRM|||Week 24||0.074|-0.067|0.927
71703672|NCT03158311|142924747|SUPERIORITY||LS Mean|0.089|STANDARD_ERROR_OF_MEAN|0.036||0.013|TWO_SIDED|95.0|0.019|0.159||P-Value is two-sided|MMRM|||Week 24||0.159|0.019|0.013
71703673|NCT00724503|142924754|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.551|TWO_SIDED|95.0|0.77|1.12|||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.||1.12|0.77|0.551
71703674|NCT00724503|142924755|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||< 0.05
71703675|NCT01186419|142924756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0765|TWO_SIDED||||||t-test, 2 sided|||||||0.0765
71703676|NCT01928771|142924761|SUPERIORITY_OR_OTHER||Rate ratio|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.71|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.71|0.42|<0.001
71703677|NCT01928771|142924761|SUPERIORITY_OR_OTHER||Rate ratio|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.64|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.64|0.37|<0.001
71703678|NCT01928771|142924762|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.047|TWO_SIDED|95.0|0.5|1.0|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.0|0.5|0.047
71703679|NCT01928771|142924762|SUPERIORITY_OR_OTHER||Rate ratio|0.83||||0.268|TWO_SIDED|95.0|0.59|1.16|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||1.16|0.59|0.268
71886495|NCT04202679|143293362|SUPERIORITY||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.02|9.55||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||9.55|2.02|<0.0001
71651855|NCT01040793|142822341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.098|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.234|0.098|<0.0001
71651856|NCT01040793|142822342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|STANDARD_ERROR_OF_MEAN|0.214||0.1176||95.0|-0.757|0.085|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.085|-0.757|0.1176
71651857|NCT01040793|142822342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.214||0.7591||95.0|-0.486|0.355|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.355|-0.486|0.7591
71651858|NCT01040793|142822343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.094|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.234|0.094|<0.0001
71651859|NCT01040793|142822343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.125|0.265|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.265|0.125|<0.0001
71762947|NCT01247272|143027356|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|113.36|||||TWO_SIDED|90.0|108.03|118.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||118.96|108.03|
71762948|NCT01247272|143027357|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.78|||||TWO_SIDED|90.0|102.18|113.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.69|102.18|
71651860|NCT01040793|142822344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.034||0.0245||95.0|0.01|0.146|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.146|0.010|0.0245
71651861|NCT01040793|142822344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.105|0.24|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.240|0.105|<0.0001
71651862|NCT01040793|142822345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.07||0.2897||95.0|-0.211|0.063|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.063|-0.211|0.2897
71651863|NCT01040793|142822345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.069||0.7199||95.0|-0.162|0.112|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.112|-0.162|0.7199
71651864|NCT01040793|142822346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.146||0.5313||95.0|-0.196|0.379|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.379|-0.196|0.5313
71651865|NCT01040793|142822346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|STANDARD_ERROR_OF_MEAN|0.146||0.0198||95.0|0.055|0.628|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.628|0.055|0.0198
71651866|NCT01040793|142822347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.053||0.1048||95.0|-0.19|0.018|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.018|-0.190|0.1048
71651867|NCT01040793|142822347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.053||0.0246||95.0|-0.224|-0.015|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.015|-0.224|0.0246
71651868|NCT01040793|142822348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001||95.0|-0.318|-0.108|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.108|-0.318|<0.0001
71651869|NCT01040793|142822348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.187|STANDARD_ERROR_OF_MEAN|0.054||0.0005||95.0|-0.293|-0.082|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.082|-0.293|0.0005
71651870|NCT01040793|142822349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.071|0.228|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.228|0.071|0.0002
71651871|NCT01040793|142822349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.04||0.0001||95.0|0.076|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.233|0.076|0.0001
71703680|NCT01928771|142924763|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.053|TWO_SIDED|95.0|0.37|1.01|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||1.01|0.37|0.053
71703681|NCT01928771|142924763|SUPERIORITY_OR_OTHER||Rate ratio|0.37|||<|0.001|TWO_SIDED|95.0|0.2|0.67|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS||||0.67|0.2|<0.001
71703682|NCT01928771|142924764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.78|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.78|0.37|<0.001
71703683|NCT01928771|142924764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.01|TWO_SIDED|95.0|0.43|0.9|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations from the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.90|0.43|0.01
71703684|NCT01928771|142924765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.49|0.82|||Regression, Cox|Model includes treatment, number of exacerbations in the previous year, region, use of OCS||Time to first exacerbation||0.82|0.49|<0.001
71703685|NCT01928771|142924765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.46|0.78|||Regression, Cox|Model includes treatment, number of exacerbations from the previous year, region, use of OCS||Time to first exacerbation||0.78|0.46|<0.001
71703686|NCT01928771|142924766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.022|TWO_SIDED|95.0|0.016|0.196|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.196|0.016|0.022
71703687|NCT01928771|142924766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.001|TWO_SIDED|95.0|0.068|0.249|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.249|0.068|0.001
71703688|NCT01928771|142924767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.644|TWO_SIDED|95.0|-0.134|0.083|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.083|-0.134|0.644
71703689|NCT01928771|142924767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.057|TWO_SIDED|95.0|-0.003|0.208|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit||||0.208|-0.003|0.057
71703690|NCT01928771|142924768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.442|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.12|-0.27|0.442
71703691|NCT01928771|142924768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.012|TWO_SIDED|95.0|-0.45|-0.06|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.06|-0.45|0.012
71703692|NCT01928771|142924769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.169|TWO_SIDED|95.0|-0.48|0.08|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||0.08|-0.48|0.169
71703693|NCT01928771|142924769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.043|TWO_SIDED|95.0|-0.57|-0.01|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment||||-0.01|-0.57|0.043
71703694|NCT01928771|142924770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.1|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.10|-1.16|0.1
71703695|NCT01928771|142924770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.081|TWO_SIDED|95.0|-1.21|0.07|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment||||0.07|-1.21|0.081
71703696|NCT01928771|142924771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.32||||0.001|TWO_SIDED|95.0|9.2|37.43|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||37.43|9.20|0.001
71762949|NCT01247272|143027358|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.99|||||TWO_SIDED|90.0|102.09|112.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.12|102.09|
71762950|NCT01247272|143027359|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.57|||||TWO_SIDED|90.0|99.54|107.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.76|99.54|
71703697|NCT01928771|142924771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.46||||0.025|TWO_SIDED|95.0|2.08|30.83|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48||30.83|2.08|0.025
71703698|NCT01928771|142924772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.75||||0.002|TWO_SIDED|95.0|7.86|35.65|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||35.65|7.86|0.002
71703699|NCT01928771|142924772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.18||||0.008|TWO_SIDED|95.0|5.09|33.28|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48||33.28|5.09|0.008
71703700|NCT01928771|142924773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED|95.0|-0.05|0.04|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||0.04|-0.05|0.964
71703701|NCT01928771|142924773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.012|TWO_SIDED|95.0|-0.11|-0.01|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment||||-0.01|-0.11|0.012
71703702|NCT01928771|142924774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.111|TWO_SIDED|95.0|-0.34|0.04|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.04|-0.34|0.111
71703703|NCT01928771|142924774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.003|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||-0.10|-0.48|0.003
71703704|NCT01928771|142924775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.27|0.27|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.27|-0.27|0.99
71703705|NCT01928771|142924775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.107|TWO_SIDED|95.0|-0.48|0.05|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment||||0.05|-0.48|0.107
71703706|NCT01928771|142924779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.081|TWO_SIDED|95.0|-0.02|0.37|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.37|-0.02|0.081
71703707|NCT01928771|142924779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment||||0.5|0.1|0.004
71703708|NCT04633447|142924831|SUPERIORITY||Difference in Percentage|6.6|||=|0.638|TWO_SIDED|90.0|-14.7|27.9|||Cochran-Mantel-Haenszel|||||27.9|-14.7|=0.638
71703709|NCT01500096|142924852|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.15
71703710|NCT01500096|142924852|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms||||0.73
71703711|NCT01500096|142924853|SUPERIORITY|||||||0.1329|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1329
71703712|NCT01500096|142924853|SUPERIORITY|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.1191
71825192|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-9.89|STANDARD_ERROR_OF_MEAN|2.48||0.0001|TWO_SIDED|95.0|-14.8|-4.99||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-4.99|-14.80|0.0001
71703713|NCT01500096|142924854|SUPERIORITY|||||||0.7454|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7454
71825193|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.54|STANDARD_ERROR_OF_MEAN|2.46||0.0089|TWO_SIDED|95.0|-11.42|-1.67||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-1.67|-11.42|0.0089
71703714|NCT01500096|142924854|SUPERIORITY|||||||0.7391|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7391
71703715|NCT01500096|142924855|SUPERIORITY|||||||0.6818|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.6818
71703716|NCT01500096|142924855|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.0579
71703717|NCT01500096|142924856|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.17
71703718|NCT01500096|142924856|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.51
71703719|NCT01500096|142924857|SUPERIORITY|||||||0.7884|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.7884
71703720|NCT01500096|142924857|SUPERIORITY|||||||0.5532|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.5532
71703721|NCT01500096|142924858|SUPERIORITY|||||||0.9885|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.9885
71703722|NCT01500096|142924858|SUPERIORITY|||||||0.2898|||||||Wilcoxon (Mann-Whitney)|2 sides Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.2898
71703723|NCT01500096|142924859|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.60
71703724|NCT01500096|142924859|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.||||0.28
71703725|NCT01500096|142924859|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.41
71703726|NCT01500096|142924859|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.||||0.72
71703727|NCT01500096|142924859|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.34
71703728|NCT01500096|142924859|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.||||0.58
71703729|NCT01500096|142924860|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 5 are significantly different between arms.||||0.31
71703730|NCT01500096|142924860|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.71
71703731|NCT01500096|142924861|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.18
71703732|NCT01500096|142924861|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.19
71703733|NCT01500096|142924862|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.47
71703734|NCT01500096|142924862|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.||||0.41
71703735|NCT01734928|142924864|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.001|TWO_SIDED|95.0|0.49|0.77|||Based on Cox proportional hazards model|||||0.77|0.49|0.001
71651872|NCT01040793|142822350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.162|0.303|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.303|0.162|<0.0001
71651873|NCT01040793|142822350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.133|0.273|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.273|0.133|<0.0001
71651874|NCT01040793|142822351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.056||0.3109||95.0|-0.053|0.166|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.166|-0.053|0.3109
71651875|NCT01040793|142822351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.056||0.608||95.0|-0.081|0.138|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.138|-0.081|0.6080
71651876|NCT01040793|142822352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.056||0.6809||95.0|-0.087|0.133|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.133|-0.087|0.6809
71703736|NCT01734928|142924865|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.571|TWO_SIDED|95.0|0.77|1.15|||Log Rank|The p-value is based on a stratified log-rank test with stratification factors as above Cox model.|Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.|||1.15|0.77|0.571
71703737|NCT01734928|142924867|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.064|TWO_SIDED|95.0|0.56|1.02|||Unstratified log-rank test|The p-value is based on an unstratified log-rank test.|Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.02|0.56|0.064
71703738|NCT01363440|142924914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.19|||<|0.0001|TWO_SIDED|97.5|9.35|15.04|||ANCOVA|||||15.04|9.35|<.0001
71703739|NCT01363440|142924914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.45|||<|0.0001|TWO_SIDED|97.5|7.73|13.17|||ANCOVA|||||13.17|7.73|<.0001
71651877|NCT01040793|142822352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.858||95.0|-0.1|0.12|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.120|-0.100|0.8580
71703740|NCT01363440|142924915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.9||||0.0001|TWO_SIDED|97.5|34.7|57.0|||Cochran-Mantel-Haenszel|||||57.0|34.7|.0001
71703741|NCT01363440|142924915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.8||||0.0001|TWO_SIDED|97.5|27.2|50.3|||Cochran-Mantel-Haenszel|||||50.3|27.2|.0001
71703742|NCT01363440|142924916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.2|||<|0.0001|TWO_SIDED|97.5|24.1|44.4|||Cochran-Mantel-Haenszel|||||44.4|24.1|<0.0001
71703743|NCT01363440|142924916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.3|||<|0.0001|TWO_SIDED|97.5|13.5|33.1|||Cochran-Mantel-Haenszel|||||33.1|13.5|<.0001
71703744|NCT01363440|142924917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7|||<|0.0001|TWO_SIDED|97.5|9.0|30.4|||Cochran-Mantel-Haenszel|||||30.4|9.0|<.0001
71703745|NCT01363440|142924917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.9||||0.0017|TWO_SIDED|97.5|4.4|25.4|||Cochran-Mantel-Haenszel|||||25.4|4.4|0.0017
71703746|NCT01363440|142924918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-110.8|||<|0.0001|TWO_SIDED|97.5|-141.3|-80.22|||ANCOVA|||||-80.22|-141.3|<.0001
71703747|NCT01363440|142924918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-113.5|||<|0.0001|TWO_SIDED|97.5|-144.2|-82.75|||ANCOVA|||||-82.75|-144.2|<.0001
71703748|NCT01363440|142924919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.19||||0.0168||97.5|0.33|10.04|||ANCOVA|||||10.04|0.33|0.0168
71703749|NCT01363440|142924919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.36||||0.0323|TWO_SIDED|97.5|-0.21|8.93|||ANCOVA|||||8.93|-0.21|0.0323
71703750|NCT01363440|142924920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.86||||0.1702|TWO_SIDED|97.5|-1.82|7.54|||ANCOVA|||||7.54|-1.82|0.1702
71703751|NCT01363440|142924920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.4067|TWO_SIDED|97.5|-2.83|6.13|||ANCOVA|||||6.13|-2.83|0.4067
71651878|NCT01040793|142822353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.148|0.073|<0.0001
71651879|NCT01040793|142822353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.148|0.073|<0.0001
71651880|NCT01040793|142822354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.151|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.233|0.151|<0.0001
71651881|NCT01040793|142822354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.153|0.236|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.236|0.153|<0.0001
71651882|NCT01040793|142822355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.036||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.191|0.047|0.0013
71651883|NCT01040793|142822355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.191|0.047|0.0013
71651884|NCT01040793|142822356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.196|0.333|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.333|0.196|<0.0001
71651885|NCT01040793|142822356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.350|0.212|<0.0001
71651886|NCT01040793|142822357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.156|0.405|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.405|0.156|<0.0001
71651887|NCT01040793|142822357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.166|0.416|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.416|0.166|<0.0001
71651888|NCT01040793|142822358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.441|0.719|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.719|0.441|<0.0001
71651889|NCT01040793|142822358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.552|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001||95.0|0.412|0.691|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.691|0.412|<0.0001
71651890|NCT03297294|142822373|SUPERIORITY|at week 12|least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.101|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA|||||0.1|-1.4|0.101
71651891|NCT03297294|142822374|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.168|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|||At week 12||0.2|-1.3|0.168
71886496|NCT04202679|143293363|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0001|TWO_SIDED|95.0|2.03|18.11||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05||18.11|2.03|0.0001
71651892|NCT03297294|142822378|SUPERIORITY||Odds Ratio (OR)|1.6||||0.255|TWO_SIDED|95.0|0.7|3.9|||Regression, Logistic|||Week 12||3.9|0.7|0.255
71651893|NCT03297294|142822379|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1|TWO_SIDED|95.0|0.8|9.6|||Regression, Logistic|||||9.6|0.8|0.100
71651894|NCT01056640|142822397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|STANDARD_ERROR_OF_MEAN|0.2865||0.05|TWO_SIDED|95.0|0.747|2.297|||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test, 2-sample t-test and Chi-square analysis were all used.||All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.||2.297|0.747|0.05
71651895|NCT01043926|142822409|NON_INFERIORITY_OR_EQUIVALENCE|"AUC(0-∞) GMR = AUC(0-∞) GM for Moderate Hepatic Insufficiency Participants ÷ AUC(0-∞) GM for Healthy Participants~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the AUC(0-∞) GMR fell below 2.00, then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.74|1.43|||ANCOVA|||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.43|0.74|
71703752|NCT01625182|142924949|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9838|TWO_SIDED|95.0|0.6|1.7|||Regression, Cox|||||1.7|0.6|0.9838
71703753|NCT00447278|142924953|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.36|||<|0.001|TWO_SIDED|95.0|-6.47|-2.25||P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.|Mixed Models Analysis|Mixed model repeated measure analysis with terms for corresponding baseline T-score, treatment, country, visit, and treatment-by-visit interaction.|Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.25|-6.47|<0.001
71651896|NCT01043926|142822410|NON_INFERIORITY_OR_EQUIVALENCE|"Cmax GMR = Cmax GM for Moderate Hepatic Insufficiency Participants ÷ Cmax GM for Healthy Participants~A 90% CI for the Cmax GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the Cmax GMR fell below 2.00, then the hypothesis would be met and the Cmax of suvorexant would be similar in both groups of participants. That is, if the true ratio of the geometric mean Cmax is no more than 2.00."|Cmax Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.68|1.29|||ANCOVA|||"The GM for each participant group and the corresponding 95% CI were calculated for Cmax using an ANCOVA model.~The Cmax GMR of the 2 participant groups was used to test the primary hypothesis, which was that the Cmax of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."||1.29|0.68|
71651897|NCT02598895|142822417|OTHER|||||||||||||||||The primary efficacy endpoint was percent patients achieving PSA decline of 50% or more from baseline (PSA50), assessed in the time prior to disease progression, unacceptable toxicity or 1 year after the last study medication. The historical comparison was PSA50 of 26%. The target response rate was 60%. The study followed an optimal two-stage Simon design (Simon, 1989) where the null hypothesis that the true PSA response rate PSA50 was 0.26 was tested against a one-sided alternative.|See above|||
71651898|NCT00104247|142822418|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71651899|NCT01886937|142822429|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
71651900|NCT00063882|142822430|SUPERIORITY||Cox Proportional Hazard|0.82||||0.21|TWO_SIDED|95.0|0.6|1.12||One-sided significance level of 0.025|Greenwood's T||Reference level = Brachytherapy only|Target sample size was 586; 532 patients were needed to test hypothesis of better FFP in the EBRT + Brachytherapy arm over the Brachytherapy Only arm. The trial is designed to detect a 10% improvement in 5-year FFP with 90% power, 1-sided alpha of 0.025. The Z-test statistic for the difference between the 2 5-year FFP rates with the standard errors estimated by Greenwood's method will be used.||1.12|0.60|0.21
71651901|NCT00063882|142822431|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.63|1.54||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.54|0.63|0.95
71651902|NCT00063882|142822432|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.64|1.58||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.58|0.64|0.97
71651903|NCT00063882|142822433|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.77|TWO_SIDED|95.0|0.36|3.9||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.90|0.36|0.77
71651904|NCT00063882|142822434|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||3.13|0.33|0.99
71651905|NCT00063882|142822435|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.81|TWO_SIDED|95.0|0.46|2.76||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||2.76|0.46|0.81
71703754|NCT00447278|142924953|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.56|-2.63||P-value for Change from Baseline: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-2.63|-6.56|<0.001
71703755|NCT00447278|142924954|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.002|TWO_SIDED|95.0|-5.08|-1.13||P-value for Change from Baseline: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.13|-5.08|0.002
71886497|NCT04202679|143293364|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0194|TWO_SIDED|95.0|1.13|7.52||Threshold of significance at 0.05 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||7.52|1.13|0.0194
71651906|NCT00063882|142822436|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.22|TWO_SIDED|95.0|0.51|1.17||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|||1.17|0.51|0.22
71651907|NCT00063882|142822437|SUPERIORITY||Odds Ratio (OR)|1.13||||0.53|TWO_SIDED|95.0|0.76|1.67||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ GU/GI||1.67|0.76|0.53
71651908|NCT00063882|142822437|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.73|1.53||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ Overall||1.53|0.73|0.73
71651909|NCT00063882|142822437|SUPERIORITY||Odds Ratio (OR)|1.09||||0.81|TWO_SIDED|95.0|0.54|2.19||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ GU/GI||2.19|0.54|0.81
71651910|NCT00063882|142822437|SUPERIORITY||Odds Ratio (OR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.69||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ Overall||1.69|0.51|0.82
71651911|NCT00063882|142822438|SUPERIORITY||Hazard Ratio (HR)|2.37||||0.01|TWO_SIDED|95.0|1.2|4.68||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ GU/GI||4.68|1.20|0.01
71651912|NCT00063882|142822438|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.029|TWO_SIDED|95.0|1.06|3.1||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ Overall||3.10|1.06|0.029
71651913|NCT00063882|142822439|SUPERIORITY||Effect size|0.4|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||<0.0001
71651914|NCT00063882|142822439|SUPERIORITY||Effect size|0.09||||0.33|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary- Incontinence||||0.33
71651915|NCT00063882|142822439|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
71651916|NCT00063882|142822439|SUPERIORITY||Effect size|0.31||||0.001|TWO_SIDED|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||0.001
71703756|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.002|TWO_SIDED|95.0|-4.92|-1.15||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.15|-4.92|0.002
71703757|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.1||||0.031|TWO_SIDED|95.0|-4.01|-0.2||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.20|-4.01|0.031
71703758|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55||||0.629|TWO_SIDED|95.0|-1.68|2.77||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.77|-1.68|0.629
71703759|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.421|TWO_SIDED|95.0|-3.3|1.38||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.38|-3.30|0.421
71703760|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05||||0.388|TWO_SIDED|95.0|-3.44|1.34||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.34|-3.44|0.388
71703761|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.29||||0.059|TWO_SIDED|95.0|-4.66|0.09||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.09|-4.66|0.059
71703762|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56||||0.006|TWO_SIDED|95.0|-6.09|-1.04||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.04|-6.09|0.006
71703763|NCT00447278|142924955|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.91||||0.027|TWO_SIDED|95.0|-5.49|-0.33||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.33|-5.49|0.027
71703764|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.073||||0.015|TWO_SIDED|95.0|0.014|0.131||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.131|0.014|0.015
71703765|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.004|TWO_SIDED|95.0|0.027|0.143||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.027|0.004
71703766|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.094||||0.063|TWO_SIDED|95.0|-0.005|0.192||P-value for Home Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.192|-0.005|0.063
71703767|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.075||||0.131|TWO_SIDED|95.0|-0.022|0.172||P-value for Home Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.172|-0.022|0.131
71703768|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.052||||0.156|TWO_SIDED|95.0|-0.02|0.124||P-value for Daily Living Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.124|-0.020|0.156
71703769|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072||||0.046|TWO_SIDED|95.0|0.001|0.143||P-value for Daily Living Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.143|0.001|0.046
71703770|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04||||0.068|TWO_SIDED|95.0|-0.003|0.084||P-value for Risk Taking Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.084|-0.003|0.068
71825194|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|2.45||0.1746|TWO_SIDED|95.0|-8.21|1.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.51|-8.21|0.1746
71703771|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.028||||0.212|TWO_SIDED|95.0|-0.016|0.073||P-value for Risk Taking Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.073|-0.016|0.212
71703772|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.121||||0.006|TWO_SIDED|95.0|0.034|0.208||P-value for School Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.208|0.034|0.006
71886498|NCT04202679|143293365|SUPERIORITY||LS mean difference|-23.16|||<|0.0001|TWO_SIDED|95.0|-33.81|-12.51||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-12.51|-33.81|<0.0001
71703773|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236||P-value for School Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.236|0.064|<0.001
71703774|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125||||0.034|TWO_SIDED|95.0|0.009|0.24||P-value for Self-Concept Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.240|0.009|0.034
71703775|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.119||||0.04|TWO_SIDED|95.0|0.005|0.233||P-value for Self-Concept Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.233|0.005|0.040
71703776|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085||||0.042|TWO_SIDED|95.0|0.003|0.166||p-value for Social Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.166|0.003|0.042
71703777|NCT00447278|142924956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.048||||0.271|TWO_SIDED|95.0|-0.038|0.134||P-value for Social Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.134|-0.038|0.271
71703778|NCT00447278|142924957|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.307||||0.034|TWO_SIDED|95.0|0.173|4.44||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.440|0.173|0.034
71703779|NCT00447278|142924957|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.072||||0.005|TWO_SIDED|95.0|0.942|5.202||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||5.202|0.942|0.005
71825195|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.14|STANDARD_ERROR_OF_MEAN|2.44|<|0.0001|TWO_SIDED|95.0|-14.96|-5.32||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-5.32|-14.96|<0.0001
71825196|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.13|STANDARD_ERROR_OF_MEAN|2.42||0.0359|TWO_SIDED|95.0|-9.91|-0.34||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.34|-9.91|0.0359
71651917|NCT00063882|142822439|SUPERIORITY||Effect size|0.12||||0.23|TWO_SIDED||||||t-test, 2 sided|||Sexual|Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|||0.23
71651918|NCT00063882|142822440|SUPERIORITY||Effect size|0.38||||0.0002|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary||||0.0002
71651919|NCT00063882|142822440|SUPERIORITY||Effect size|0.08||||0.42|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Incontinence||||0.42
71651920|NCT00063882|142822440|SUPERIORITY||Effect size|0.44|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Urinary-Irritative||||<0.0001
71651921|NCT00063882|142822440|SUPERIORITY||Effect size|0.42|||<|0.0001|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Bowel||||<0.0001
71651922|NCT00063882|142822440|SUPERIORITY||Effect size|0.27||||0.0072|TWO_SIDED|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7.|Sexual||||0.0072
71651923|NCT03314662|142822458|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio (aTIV/aQIV)|1.16|||||TWO_SIDED|95.0|1.05|1.27|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - for strain A/H1N1||1.27|1.05|
71651924|NCT03314662|142822458|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5|GMT ratio: (aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log 10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aTIV/aQIV - performed for strain A/H3N2||1.09|0.90|
71651925|NCT03314662|142822458|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: aTIV/aQIV|0.99|||||TWO_SIDED|95.0|0.9|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Yamagata||1.08|0.90|
71651926|NCT03314662|142822458|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% confidence interval (CI) for the ratios of GMTs (aTIV/aQIV) do not exceed 1.5.|GMT ratio: (aTIV/aQIV)]|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||GMT ratios (adjusted) obtained from a GLM fitted on log-transformed (base 10) post-vaccination HI titer as outcome variable and covariate terms: treatment, pre-vaccination HI titer (log10 transformed), age, sex, vaccination history, study site|Comparison Group Selection: aQIV/aTIV - performed for strain B/Victoria||1.08|0.89|
71651927|NCT03314662|142822459|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|3.23|||||TWO_SIDED|95.0|-1.3|7.76||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H1N1||7.76|-1.30|
71651928|NCT03314662|142822459|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)|0.37|||||TWO_SIDED|95.0|-4.23|4.96||||||Comparison Group Selection: aTIV minus aQIV - for strain A/H3N2||4.96|-4.23|
71651929|NCT03314662|142822459|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|SCR difference (aTIV minus aQIV)]|-0.93|||||TWO_SIDED|95.0|-5.13|3.27||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Yamagata||3.27|-5.13|
71703780|NCT00447278|142924957|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.721||||0.004|TWO_SIDED|95.0|0.544|2.899||P-value for Inattention Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.899|0.544|0.004
71651930|NCT03314662|142822459|NON_INFERIORITY|aQIV was considered non-inferior to aTIV-1 or aTIV-2 if the upper bound of the two-sided 95% CI for the differences between the SCRs (aTIV - aQIV) do not exceed 10% for each of the four strains|Other [SCR difference (aTIV minus aQIV)]|-1.26|||||TWO_SIDED|95.0|-5.07|2.55||||||Comparison Group Selection: aTIV minus aQIV - for strain B-Victoria||2.55|-5.07|
71651931|NCT03314662|142822462|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the Full Analysis Set (FAS) Immunogenicity comprised all subjects who were randomized, received at least 1 study vaccination, and provided immunogenicity data at Day 1 and Day 22.|GMT ratio|0.64|||||TWO_SIDED|95.0|0.58|0.7||||||B/Yamagata strain: GMT Ratio (aTIV/aQIV)||0.70|0.58|
71651932|NCT03314662|142822462|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the GMT ratio (GMTaTIV/GMTaQIV); Superiority was declared if the upper limit of the two-sided 95% CI for the GMT ratio (aTIV/aQIV) was \<1. The superiority comparison was based on the FAS Immunogenicity.|GMT ratio|0.71|||||TWO_SIDED|95.0|0.64|0.78||||||B/Victoria Strain: GMT Ratio (aTIV/aQIV)||0.78|0.64|
71651933|NCT03314662|142822465|SUPERIORITY|Superiority of aQIV vs. aTIV-1 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-11.96|||||TWO_SIDED|95.0|-15.12|-8.81||||||B/Yamagata Strain: SCR Difference (aTIV-1 - aQIV).||-8.81|-15.12|
71651934|NCT03314662|142822465|SUPERIORITY|Superiority of aQIV vs. aTIV-2 for the alternate B strain was assessed using the difference in SCR (SCRaTIV-SCRaQIV) at Day 22. Superiority was declared if the upper limit of the two-sided 95% CI for the difference in SCRs (aTIV-aQIV) was \<0, for both B strains. The superiority comparison was based on the FAS Immunogenicity.|SCR difference|-10.82|||||TWO_SIDED|95.0|-13.54|-8.11||||||B/Victoria Strain: SCR Difference (aTIV-2 - aQIV)||-8.11|-13.54|
71651935|NCT00925301|142822471|SUPERIORITY||Difference|12.5||||0.2996|TWO_SIDED|95.0|-13.4|37.3|||Cochran-Mantel-Haenszel|p-value from Cochran-Mantel-Haenszel test stratified by sex|The difference between the percentage of successes between migalastat and placebo treatment groups|||37.3|-13.4|0.2996
71651936|NCT00925301|142822474|OTHER|Mixed effects model for repeated measures (MMRM) approach with fixed effects of treatment, time (Month 6 and Month 12), mutation type (amenable or non-amenable), time by treatment interaction, time by mutation type interaction, and the baseline value as a covariate. An unstructured covariance matrix to account for repeated measures within a participant was assumed.||||||0.014||||||Significant at the 0.050 level|MMRM|||||||0.014
71651937|NCT00925301|142822475|OTHER||Difference LSMeans|-0.3||||0.0078|TWO_SIDED|95.0|-0.6|-0.1||Significant at the 0.010 level|ANCOVA|||The change from Baseline in the average number of kidney ICs was analyzed using an ANCOVA model with covariate adjustment for the baseline value and factors for treatment group and the treatment by baseline interaction.||-0.1|-0.6|0.0078
71651938|NCT01117766|142822476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.537||0.7319|TWO_SIDED|95.0|-1.29|0.92|||ANCOVA|||Week 3 (Visits 3 and 6)||0.92|-1.29|0.7319
71651939|NCT01117766|142822476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.536||0.3404|TWO_SIDED|95.0|-1.61|0.57|||ANCOVA|||Week 4 (Visits 4 and 7)||0.57|-1.61|0.3404
71651940|NCT01117766|142822477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|STANDARD_ERROR_OF_MEAN|26.872||0.6539|TWO_SIDED|95.0|-70.2|45.56|||ANCOVA|||Week 3 (Visits 3 and 6)||45.56|-70.20|0.6539
71703781|NCT00447278|142924957|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.269|||<|0.001|TWO_SIDED|95.0|1.086|3.453||P-value for Inattention Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.453|1.086|<0.001
71651941|NCT01117766|142822477|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.91|STANDARD_ERROR_OF_MEAN|25.807||0.3678|TWO_SIDED|95.0|-78.54|30.72|||ANCOVA|||Week 4 (Visits 4 and 7)||30.72|-78.54|0.3678
71651942|NCT01117766|142822478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.342||0.0071|TWO_SIDED|95.0|-1.84|-0.35|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||-0.35|-1.84|0.0071
71651943|NCT01117766|142822478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.37||0.1294|TWO_SIDED|95.0|-1.36|0.19|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.19|-1.36|0.1294
71651944|NCT01117766|142822479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.54|STANDARD_ERROR_OF_MEAN|25.298||0.03|TWO_SIDED|95.0|-116.12|-6.96|||ANCOVA|||Week 3 (Visits 3 and 6)||-6.96|-116.12|0.0300
71651945|NCT01117766|142822479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.06|STANDARD_ERROR_OF_MEAN|26.501||0.0844|TWO_SIDED|95.0|-105.67|7.55|||ANCOVA|||Week 4 (Visits 4 and 7)||7.55|-105.67|0.0844
71651946|NCT01117766|142822480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.478||0.7506|TWO_SIDED|95.0|-0.83|1.14|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.14|-0.83|0.7506
71651947|NCT01117766|142822480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.299||0.9673|TWO_SIDED|95.0|-0.61|0.64|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.64|-0.61|0.9673
71651948|NCT01117766|142822481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.642||0.5502|TWO_SIDED|95.0|-0.99|1.78|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)||1.78|-0.99|0.5502
71651949|NCT01117766|142822481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.5||0.8536|TWO_SIDED|95.0|-1.15|0.96|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)||0.96|-1.15|0.8536
71651950|NCT01117766|142822482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.586||0.0132|TWO_SIDED|95.0|-2.73|-0.34|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 3 (Visits 3 and 6)||-0.34|-2.73|0.0132
71651951|NCT01117766|142822482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.467||0.0403|TWO_SIDED|95.0|-1.95|-0.05|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 'improved', 4 'no change' and 5-7 'worsened'.|Week 4 (Visits 4 and 7)||-0.05|-1.95|0.0403
71703782|NCT00447278|142924957|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58||||0.298|TWO_SIDED|95.0|-0.515|1.676||P-value for Hyperactivity Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.676|-0.515|0.298
71703783|NCT00447278|142924957|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.865||||0.119|TWO_SIDED|95.0|-0.225|1.956||P-value for Hyperactivity Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.956|-0.225|0.119
71703784|NCT00447278|142924958|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.104||||0.366|TWO_SIDED|95.0|-0.122|0.329||P-value for Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.329|-0.122|0.366
71703785|NCT00447278|142924958|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.169||||0.165|TWO_SIDED|95.0|-0.07|0.407||P-value for Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.407|-0.070|0.165
71703786|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.35||||0.054|TWO_SIDED|95.0|-4.74|0.04||P-value for Achievement Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.04|-4.74|0.054
71703787|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.71||||0.003|TWO_SIDED|95.0|-6.16|-1.26||P-value for Achievement Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-1.26|-6.16|0.003
71703788|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.74||||0.033|TWO_SIDED|95.0|-3.33|-0.14||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.14|-3.33|0.033
71703789|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5||||0.003|TWO_SIDED|95.0|-4.12|-0.88||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.88|-4.12|0.003
71703790|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5||||0.623|TWO_SIDED|95.0|-1.5|2.5||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.50|-1.50|0.623
71703791|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16||||0.88|TWO_SIDED|95.0|-1.96|2.29||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.29|-1.96|0.880
71703792|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.149|TWO_SIDED|95.0|-3.31|0.5||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.50|-3.31|0.149
71703793|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.78||||0.003|TWO_SIDED|95.0|-4.58|-0.98||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-4.58|0.003
71651952|NCT01117766|142822483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.433||0.6631|TWO_SIDED|95.0|-1.12|0.74|||ANCOVA|||Week 3 (Visits 3 and 6)||0.74|-1.12|0.6631
71651953|NCT01117766|142822483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|0.465||0.0022|TWO_SIDED|95.0|-2.48|-0.59|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.59|-2.48|0.0022
71703794|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.62||||0.015|TWO_SIDED|95.0|-4.71|-0.52||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.52|-4.71|0.015
71703795|NCT00447278|142924959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12||||0.004|TWO_SIDED|95.0|-5.26|-0.98||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.98|-5.26|0.004
71651954|NCT01117766|142822484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.722||0.1753|TWO_SIDED|95.0|-2.6|0.53|||ANCOVA|||Week 3 (Visits 3 and 6)||0.53|-2.60|0.1753
71651955|NCT01117766|142822484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51|STANDARD_ERROR_OF_MEAN|0.588||0.0198|TWO_SIDED|95.0|-2.75|-0.27|||ANCOVA|||Week 4 (Visits 4 and 7)||-0.27|-2.75|0.0198
71651956|NCT01117766|142822485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29|STANDARD_ERROR_OF_MEAN|6.292||0.4999|TWO_SIDED|95.0|-17.13|8.54|||ANCOVA|||||8.54|-17.13|0.4999
71651957|NCT03064438|142822511|SUPERIORITY||Difference of Least Squares (LS) Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.366|TWO_SIDED|95.0|-2.162|5.727|||t-test, 2 sided|||||5.727|-2.162|0.366
71651958|NCT03064438|142822512|SUPERIORITY|||||||0.1099|||||||Van Elteren test|||Percent change from baseline at Week 2||||0.1099
71651959|NCT03064438|142822512|SUPERIORITY|||||||0.1653|||||||Van Elteren test|||Percent change from baseline at Week 4||||0.1653
71651960|NCT03064438|142822512|SUPERIORITY|||||||0.8437|||||||Van Elteren test|||Percent change from baseline at Week 8||||0.8437
71651961|NCT03064438|142822512|SUPERIORITY|||||||0.4644|||||||Van Elteren test|||Percent change from baseline at Week 12||||0.4644
71651962|NCT03064438|142822513|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71651963|NCT03064438|142822514|SUPERIORITY||Difference of LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.91||0.495|TWO_SIDED|95.0|-2.571|5.211|||t-test, 2 sided|||Change from baseline at Week 2||5.211|-2.571|0.495
71651964|NCT03064438|142822514|SUPERIORITY||Difference of LS Mean|-1.5|STANDARD_ERROR_OF_MEAN|1.74||0.399|TWO_SIDED|95.0|-5.014|2.045|||t-test, 2 sided|||Change from baseline at Week 4||2.045|-5.014|0.399
71651965|NCT03064438|142822514|SUPERIORITY||Difference of LS Mean|2.2|STANDARD_ERROR_OF_MEAN|2.07||0.29|TWO_SIDED|95.0|-1.965|6.407|||t-test, 2 sided|||Change from baseline at Week 8||6.407|-1.965|0.290
71651966|NCT03064438|142822514|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.83||0.343|TWO_SIDED|95.0|-1.953|5.469|||t-test, 2 sided|||Change from baseline at Week 12||5.469|-1.953|0.343
71651967|NCT03064438|142822515|SUPERIORITY||Difference of LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.407|TWO_SIDED|95.0|-0.894|2.155|||t-test, 2 sided|||Change from baseline at Week 2||2.155|-0.894|0.407
71703796|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.39||||0.263|TWO_SIDED|95.0|-1.83|6.6||P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||6.60|-1.83|0.263
71703797|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38||||0.848|TWO_SIDED|95.0|-3.6|4.36||P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||4.36|-3.60|0.848
71703798|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19||||0.895|TWO_SIDED|95.0|-3.01|2.64||P-value for Statisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.64|-3.01|0.895
71886499|NCT04202679|143293366|SUPERIORITY||LS mean difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.42|-4.36||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-4.36|-8.42|<0.0001
71651968|NCT03064438|142822515|SUPERIORITY||Difference of LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.36||0.291|TWO_SIDED|95.0|-0.342|1.109|||t-test, 2 sided|||Change from baseline at Week 4||1.109|-0.342|0.291
71651969|NCT03064438|142822515|SUPERIORITY||Difference of LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|95.0|-0.763|1.073|||t-test, 2 sided|||Change from baseline at Week 8||1.073|-0.763|0.734
71651970|NCT03064438|142822515|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.952|TWO_SIDED|95.0|-1.128|1.197|||t-test, 2 sided|||Change from baseline in pustule lesions at Week 12||1.197|-1.128|0.952
71651971|NCT03064438|142822516|SUPERIORITY||Difference of LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.313|TWO_SIDED|95.0|-0.215|0.069|||t-test, 2 sided|||Change from baseline at Week 2||0.069|-0.215|0.313
71651972|NCT03064438|142822516|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.942|TWO_SIDED|95.0|-0.141|0.152|||t-test, 2 sided|||Change from baseline at Week 4||0.152|-0.141|0.942
71651973|NCT03064438|142822516|SUPERIORITY||Difference of LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.284|TWO_SIDED|95.0|-0.067|0.226|||t-test, 2 sided|||Change from baseline in nodule lesions at Week 8||0.226|-0.067|0.284
71651974|NCT03064438|142822516|SUPERIORITY||Difference of LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.542|TWO_SIDED|95.0|-0.198|0.105|||t-test, 2 sided|||Change from baseline at Week 12||0.105|-0.198|0.542
71651975|NCT03064438|142822517|SUPERIORITY||Difference of LS Mean|2.0|STANDARD_ERROR_OF_MEAN|2.04||0.333|TWO_SIDED|95.0|-2.135|6.139|||t-test, 2 sided|||Change from baseline at Week 2||6.139|-2.135|0.333
71651976|NCT03064438|142822517|SUPERIORITY||Difference of LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.9||0.591|TWO_SIDED|95.0|-4.882|2.822|||t-test, 2 sided|||Change from baseline at Week 4||2.822|-4.882|0.591
71651977|NCT03064438|142822517|SUPERIORITY||Difference of LS Mean|2.5|STANDARD_ERROR_OF_MEAN|2.12||0.254|TWO_SIDED|95.0|-1.84|6.758|||t-test, 2 sided|||Change from baseline at Week 8||6.758|-1.840|0.254
71651978|NCT03064438|142822517|SUPERIORITY||Difference of LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.95||0.356|TWO_SIDED|95.0|-2.131|5.779|||t-test, 2 sided|||Change from baseline at Week 12||5.779|-2.131|0.356
71651979|NCT03407612|142822523|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.67|||||||t-test, 2 sided|||This analysis considers the baseline HOS-ADL measures.||||0.67
71703799|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.2||||0.038|TWO_SIDED|95.0|-6.22|-0.19||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||-0.19|-6.22|0.038
71651980|NCT03407612|142822523|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.73|||||||t-test, 2 sided|||This analysis considers the 6 week postoperative HOS-ADL measures.||||0.73
71651981|NCT03407612|142822523|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.87|||||||t-test, 2 sided|||This analysis considers the 12 week postoperative HOS-ADL measures.||||0.87
71651982|NCT03407612|142822523|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.78|||||||t-test, 2 sided|||This analysis considers the 6 month postoperative HOS-ADL measures.||||0.78
71651983|NCT03407612|142822524|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.25|||||||t-test, 2 sided|||||||0.25
71651984|NCT03407612|142822525|EQUIVALENCE|p \< 0.05 required for groups to have non-equivalent results.||||||0.04|||||||t-test, 2 sided|||||||0.04
71651985|NCT01552369|142822586|SUPERIORITY|||||||0.0396|||||||Mantel Haenszel|||||||0.0396
71651986|NCT01552369|142822586|SUPERIORITY||Hazard Ratio (HR)|2.22||||0.048|TWO_SIDED|95.0|1.01|7.3|||Competing risk regression|Death was considered a competing risk.|The risk of CMV disease is 2.2x higher in the prophylaxis group when compared to the preemptive group|||7.3|1.01|0.048
71651987|NCT01552369|142822587|SUPERIORITY|log-rank test for equality of survivor functions||||||0.19|||||||Log Rank|||||||0.19
71651988|NCT01552369|142822588|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.45|1.58|||Mantel Haenszel||The odds of rejection in prophylaxis group compared to preemptive group|||1.58|0.45|0.60
71651989|NCT01552369|142822589|SUPERIORITY||Odds Ratio (OR)|0.95||||0.96|TWO_SIDED|95.0|0.13|6.92|||Mantel Haenszel||The odds of graft loss in prophylaxis group compared to preemptive group|||6.92|0.13|0.96
71651990|NCT01552369|142822590|SUPERIORITY||Odds Ratio (OR)|3.24||||0.014|TWO_SIDED|95.0|1.21|8.69|||Mantel Haenszel||Odds of late disease in prophylaxis group compared to preemptive|||8.69|1.21|0.014
71651991|NCT01552369|142822591|SUPERIORITY||Odds Ratio (OR)|1.17||||0.64|TWO_SIDED|95.0|0.61|2.23|||Mantel Haenszel||Odds of bacterial infection in prophylaxis subjects compared to preemptive|||2.23|0.61|0.64
71651992|NCT01552369|142822592|SUPERIORITY||Odds Ratio (OR)|2.25||||0.18|TWO_SIDED|95.0|0.66|7.62|||Mantel Haenszel||Odds of fungal disease in prophylaxis group compared to preemptive|||7.62|0.66|0.18
71651993|NCT01552369|142822593|SUPERIORITY|||||||0.24|||||||Fisher Exact|||||||0.24
71651994|NCT01552369|142822594|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71651995|NCT01552369|142822595|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
71703800|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.854|TWO_SIDED|95.0|-3.59|2.98||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||2.98|-3.59|0.854
71703801|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.26||||0.161|TWO_SIDED|95.0|-5.45|0.92||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.92|-5.45|0.161
71651996|NCT01552369|142822596|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
71651997|NCT02551679|142822624|SUPERIORITY||Cox Proportional Hazard|2.046||||0.258|TWO_SIDED|95.0|0.577|7.255|||ANCOVA|||The primary hypothesis of this study is that ACP-01 is superior to placebo in terms of the earlier time from treatment with Investigational Medicinal Product (IMP) to either de-novo gangrene, or doubling of wound size, or major amputation, or death.||7.255|0.577|0.258
71703802|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7||||0.54|TWO_SIDED|95.0|-2.98|1.58||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||1.58|-2.98|0.540
71651998|NCT01002794|142822649|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||Power calculation: The sample size calculation was based on the change in KOOS4 from baseline to two year follow-up. To detect a 10 point difference with a standard deviation of 15, with a level of power of 90%, level of significance of 0.05, and an estimated 15% dropout rate at two years, we determined that we would need 56 participants in each group. To allow for a 20% crossover rate, we randomised 140 participants.||||<0.05
71762951|NCT01247272|143027360|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|101.66|110.12|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.12|101.66|
71651999|NCT02065713|142822685|SUPERIORITY||||||=|0.026|||||||Wilcoxon (Mann-Whitney)|||||||=0.026
71652000|NCT03614494|142822686|SUPERIORITY||Risk Difference (RD)|31.4|||<|0.0001|TWO_SIDED|95.0|26.2|36.4|||Chi-squared|||||36.4|26.2|<0.0001
71652001|NCT03614494|142822687|SUPERIORITY||Odds Ratio (OR)|0.197||||0.036|TWO_SIDED|95.0|0.021|0.906|||Logistic regression, Firth's bias reduct|||||0.906|0.021|0.036
71652002|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.857||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in length z-score.||||0.857
71652003|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.901||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in weight z-score.||||0.901
71652004|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.807||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in head circumference z-score.||||0.807
71652005|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.595|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.595
71652006|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.||||0.016
71652007|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.347
71652008|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.||||0.040
71652009|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.892|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.892
71652010|NCT00868296|142822697|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.||||0.006
71774893|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-2.99|STANDARD_ERROR_OF_MEAN|2.41||0.216|TWO_SIDED|95.0|-7.74|1.75|||ANCOVA|||Week 16 adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||1.75|-7.74|0.2160
71652011|NCT02075606|142822708|OTHER||Odds Ratio (OR)|0.17|||=|0.126|TWO_SIDED|95.0|0.02|1.65|||Regression, Logistic|||Clinical symptomatic response as dependent variable and CTC presence at baseline as explanatory variable was used to perform the logistic regression analysis.||1.65|0.02|=0.126
71652012|NCT02462486|142822715|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-5.0|2.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||2.4|-5.0|
71652013|NCT02462486|142822715|NON_INFERIORITY|For hypothesis testing, if the lower limit of the 95.1% confidence interval for the difference between an abicipar group and ranibizumab is greater than or equal to -10%, non-inferiority of abicipar group is established.|Percentage Difference|-4.6|||||TWO_SIDED|95.0|-9.0|-0.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||-0.5|-9.0|
71652014|NCT02462486|142822716|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-2.4|2.0|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||2.0|-2.4|
71652015|NCT02462486|142822716|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.1|-3.8|0.6|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||0.6|-3.8|
71652016|NCT02462486|142822717|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-7.1|14.0|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||14.0|-7.1|
71652017|NCT02462486|142822717|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.1|-4.7|16.5|||||MMRM included treatment, region, BL BCVA, BL CRT, choroidal neovascularization lesion type, visit, visit-by-baseline CRT interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||16.5|-4.7|
71652018|NCT02462486|142822718|SUPERIORITY||Percentage Difference|1.4|||||TWO_SIDED|95.0|-5.5|8.4|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||8.4|-5.5|
71703803|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.98||||0.106|TWO_SIDED|95.0|-4.4|0.44||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.44|-4.40|0.106
71703804|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.833|TWO_SIDED|95.0|-2.49|3.08||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||3.08|-2.49|0.833
71825197|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.01|STANDARD_ERROR_OF_MEAN|2.41||0.0395|TWO_SIDED|95.0|-9.78|-0.24||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-0.24|-9.78|0.0395
71825198|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0278|TWO_SIDED|95.0|0.02|0.27||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.27|0.02|0.0278
71825199|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.2||95.0|-0.04|0.2||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.20|-0.04|0.2000
71825200|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3396|TWO_SIDED|95.0|-0.06|0.18||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.18|-0.06|0.3396
71825201|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.56|STANDARD_ERROR_OF_MEAN|3.22|<|0.0001|TWO_SIDED|95.0|-20.93|-8.19||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-8.19|-20.93|<0.0001
71825202|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.11|STANDARD_ERROR_OF_MEAN|3.2||0.0584|TWO_SIDED|95.0|-12.43|0.22||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||0.22|-12.43|0.0584
71825203|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.45|STANDARD_ERROR_OF_MEAN|3.19||0.009|TWO_SIDED|95.0|-14.76|-2.15||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||-2.15|-14.76|0.0090
71825204|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.69|STANDARD_ERROR_OF_MEAN|2.28||0.2405|TWO_SIDED|95.0|-7.2|1.82||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||1.82|-7.20|0.2405
71703805|NCT00447278|142924960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.54||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.|||0.54|-5.21|0.110
71703806|NCT02810327|142924993|OTHER|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||The MUSC Bioinformatics Core analyzed group genomic data for variant association with COPD severity score, including single variant association or type of variant association with symptoms. Descriptive statistical analysis was performed using statistical package SAS 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).||||0.054
71703807|NCT02384460|142925021|OTHER||Hazard Ratio (HR)|1.004||||0.985|TWO_SIDED|95.0|0.651|1.549||p-value is for Type 3 chi-square test for comparison between treatments.|Cox Model Analysis|||Cox proportional hazards model compares treatment groups with baseline target wound size, target wound age, and EB type as covariates.||1.549|0.651|0.985
71738854|NCT02106403|142990599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.18||||0.4645|TWO_SIDED|95.0|-8.09|3.72|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||3.72|-8.09|0.4645
71652019|NCT02462486|142822718|SUPERIORITY||Percentage Difference|-2.3|||||TWO_SIDED|95.0|-9.1|4.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||4.5|-9.1|
71652020|NCT02462486|142822719|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.5|0.3|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||0.3|-3.5|
71652021|NCT02462486|142822719|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.1|-3.9|-0.1|||||MMRM included treatment group, region, baseline BCVA in the study eye, baseline VFQ score, visit, and treatment by visit interaction as fixed covariates using an unstructured covariance matrix.|||-0.1|-3.9|
71652022|NCT02310763|142822737|SUPERIORITY||Mean Difference (Net)|1.293|STANDARD_ERROR_OF_MEAN|1.022||0.2088|TWO_SIDED|95.0|-0.7343|3.32||The significance level is 0.05.|ANCOVA||Least square mean difference was calculated by placebo minus domagrozumab.|||3.3200|-0.7343|0.2088
71652023|NCT02310763|142822741|SUPERIORITY||Mean Difference (Net)|-0.0845||||0.9191|TWO_SIDED|95.0|-1.7354|1.5663||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.5663|-1.7354|0.9191
71652024|NCT02310763|142822741|SUPERIORITY||Mean Difference (Net)|0.5837||||0.7642|TWO_SIDED|95.0|-3.2978|4.4652||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4652|-3.2978|0.7642
71762952|NCT01247272|143027361|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.83|||||TWO_SIDED|90.0|101.27|110.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||110.61|101.27|
71762953|NCT00947882|143027364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0911||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0911
71652025|NCT02310763|142822741|SUPERIORITY||Mean Difference (Net)|0.2712||||0.9423|TWO_SIDED|95.0|-7.3799|7.9223||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.9223|-7.3799|0.9423
71652026|NCT02310763|142822742|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.0693|0.0693||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||0.0693|-0.0693|0.9993
71652027|NCT02310763|142822742|SUPERIORITY||Mean Difference (Net)|-0.0259||||0.5464|TWO_SIDED|95.0|-0.1107|0.0589||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||0.0589|-0.1107|0.5464
71652028|NCT02310763|142822742|SUPERIORITY||Mean Difference (Net)|-0.042||||0.3041|TWO_SIDED|95.0|-0.1227|0.0386||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||0.0386|-0.1227|0.3041
71652029|NCT02310763|142822743|SUPERIORITY||Mean Difference (Net)|0.8||||0.3522|TWO_SIDED|95.0|-0.9|2.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||2.5|-0.9|0.3522
71652030|NCT02310763|142822743|SUPERIORITY||Mean Difference (Net)|2.5||||0.0061|TWO_SIDED|95.0|0.7|4.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.2|0.7|0.0061
71652031|NCT02310763|142822743|SUPERIORITY|Week 49|Mean Difference (Net)|1.6||||0.1268|TWO_SIDED|95.0|-0.5|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|||3.8|-0.5|0.1268
71652032|NCT02310763|142822744|SUPERIORITY||Mean Difference (Net)|-0.4||||0.7337|TWO_SIDED|95.0|-2.9|2.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 17||2.1|-2.9|0.7337
71762954|NCT00947882|143027364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0865|TWO_SIDED|||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0865
71762955|NCT00947882|143027364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.2342||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2342
71652033|NCT02310763|142822744|SUPERIORITY||Mean Difference (Net)|0.2||||0.8893|TWO_SIDED|95.0|-2.4|2.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 33||2.7|-2.4|0.8893
71652034|NCT02310763|142822744|SUPERIORITY||Mean Difference (Net)|-1.5||||0.2939|TWO_SIDED|95.0|-4.3|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 49||1.3|-4.3|0.2939
71762956|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.0367||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0367
71762957|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0231||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.0231
71762958|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.1638||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1638
71762959|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1941||||||P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1941
71762960|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.1083||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1083
71762961|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.2782||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.2782
71762962|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.1562||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1562
71762963|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.1736||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.1736
71762964|NCT00947882|143027365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.3132||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.||||0.3132
71652035|NCT02310763|142822744|SUPERIORITY||Mean Difference (Net)|0.8||||0.5995|TWO_SIDED|95.0|-2.1|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 17||3.6|-2.1|0.5995
71652036|NCT02310763|142822744|SUPERIORITY||Mean Difference (Net)|2.9||||0.0385|TWO_SIDED|95.0|0.2|5.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 33||5.6|0.2|0.0385
71652037|NCT02310763|142822744|SUPERIORITY||Mean Difference (Net)|0.0||||0.9927|TWO_SIDED|95.0|-3.3|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 49||3.2|-3.3|0.9927
71652038|NCT02310763|142822745|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6049|TWO_SIDED|95.0|-1.7|1.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||1.0|-1.7|0.6049
71652039|NCT02310763|142822745|SUPERIORITY||Mean Difference (Net)|1.7||||0.2065|TWO_SIDED|95.0|-1.0|4.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||4.4|-1.0|0.2065
71652040|NCT02310763|142822745|SUPERIORITY||Mean Difference (Net)|0.0||||0.9391|TWO_SIDED|95.0|-1.3|1.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||1.2|-1.3|0.9391
71652041|NCT02310763|142822746|SUPERIORITY||Mean Difference (Net)|1.8||||0.8499|TWO_SIDED|95.0|-16.7|20.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||20.3|-16.7|0.8499
71652042|NCT02310763|142822746|SUPERIORITY||Mean Difference (Net)|8.9||||0.4008|TWO_SIDED|95.0|-12.0|29.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||29.8|-12.0|0.4008
71652043|NCT02310763|142822746|SUPERIORITY||Mean Difference (Net)|-1.5||||0.916|TWO_SIDED|95.0|-30.0|27.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||27.0|-30.0|0.9160
71652044|NCT02310763|142822747|SUPERIORITY||Mean Difference (Net)|0.115||||0.5726|TWO_SIDED|95.0|-0.287|0.517||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 17||0.517|-0.287|0.5726
71762965|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.2034|TWO_SIDED|95.0|0.814|2.628||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 3."|||2.628|0.814|0.2034
71652045|NCT02310763|142822747|SUPERIORITY||Mean Difference (Net)|-0.163||||0.4334|TWO_SIDED|95.0|-0.574|0.248||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 33||0.248|-0.574|0.4334
71652046|NCT02310763|142822747|SUPERIORITY||Mean Difference (Net)|-0.126||||0.5767|TWO_SIDED|95.0|-0.573|0.321||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 49||0.321|-0.573|0.5767
71652047|NCT02310763|142822747|SUPERIORITY||Mean Difference (Net)|-0.022||||0.9274|TWO_SIDED|95.0|-0.489|0.446||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 17||0.446|-0.489|0.9274
71652048|NCT02310763|142822747|SUPERIORITY||Mean Difference (Net)|-0.439||||0.0469|TWO_SIDED|95.0|-0.872|-0.006||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 33||-0.006|-0.872|0.0469
71652049|NCT02310763|142822747|SUPERIORITY||Mean Difference (Net)|-0.166||||0.4362|TWO_SIDED|95.0|-0.587|0.255||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 49||0.255|-0.587|0.4362
71652050|NCT02310763|142822748|SUPERIORITY||Mean Difference (Net)|-0.156||||0.5557|TWO_SIDED|95.0|-0.679|0.367||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 17||0.367|-0.679|0.5557
71652051|NCT02310763|142822748|SUPERIORITY||Mean Difference (Net)|-0.303||||0.2669|TWO_SIDED|95.0|-0.841|0.235||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 33||0.235|-0.841|0.2669
71652052|NCT02310763|142822748|SUPERIORITY||Mean Difference (Net)|-0.161||||0.4665|TWO_SIDED|95.0|-0.598|0.276||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 49||0.276|-0.598|0.4665
71652053|NCT02310763|142822748|SUPERIORITY||Mean Difference (Net)|-0.083||||0.7335|TWO_SIDED|95.0|-0.564|0.399||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 17||0.399|-0.564|0.7335
71652054|NCT02310763|142822748|SUPERIORITY||Mean Difference (Net)|-0.361||||0.1695|TWO_SIDED|95.0|-0.877|0.156||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 33||0.156|-0.877|0.1695
71652055|NCT02310763|142822748|SUPERIORITY||Mean Difference (Net)|-0.189||||0.3783|TWO_SIDED|95.0|-0.612|0.234||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 49||0.234|-0.612|0.3783
71652056|NCT02310763|142822749|SUPERIORITY||Mean Difference (Net)|-0.586||||0.1078|TWO_SIDED|95.0|-1.303|0.13||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 17||0.130|-1.303|0.1078
71652057|NCT02310763|142822749|SUPERIORITY||Mean Difference (Net)|0.046||||0.8967|TWO_SIDED|95.0|-0.654|0.746||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 33||0.746|-0.654|0.8967
71652058|NCT02310763|142822749|SUPERIORITY||Mean Difference (Net)|-0.378||||0.3196|TWO_SIDED|95.0|-1.128|0.371||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 49||0.371|-1.128|0.3196
71652059|NCT02310763|142822749|SUPERIORITY||Mean Difference (Net)|-0.689||||0.0526|TWO_SIDED|95.0|-1.386|0.008||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 17||0.008|-1.386|0.0526
71825205|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.26||0.7565|TWO_SIDED|95.0|-5.18|3.77||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||3.77|-5.18|0.7565
71703808|NCT02384460|142925022|OTHER|Multiple imputation was implemented by 2 steps. The first step used Markov Chain Monte Carlo (MCMC) to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 010005 and the number of imputations was 5.|Odds Ratio (OR)|0.733||||0.39|TWO_SIDED|95.0|0.365|1.474||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Comparison between treatment groups of complete closure of target wound within 3 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.474|0.365|0.39
71703809|NCT02384460|142925023|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get the monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation method: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|1.633||||0.212|TWO_SIDED|95.0|0.758|3.517||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 1 visit. Comparison between treatment groups of complete closure of target wound within 1 month was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||3.517|0.758|0.212
71703810|NCT02384460|142925023|OTHER|Multiple imputation was implemented by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|0.891||||0.802|TWO_SIDED|95.0|0.436|1.821||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 2 visit. Comparison between treatment groups of complete closure of target wound within 2 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.||1.821|0.436|0.802
71703811|NCT02384460|142925024|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.682||||0.706|TWO_SIDED|95.0|-2.873|4.238||The p-value is calculated based on the hypothesis testing for the difference of least-squares (LS)-means between treatment and placebo.|Mixed Models Analysis|||Mixed Model Repeated Measures (MMRM) Analysis. The MMRM approach (using restricted maximum likelihood \[REML\] estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||4.238|-2.873|0.706
71703812|NCT02384460|142925025|OTHER|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.128||||0.9|TWO_SIDED|95.0|-2.116|1.861||The p-value is calculated based on the hypothesis testing for the difference of LS-means between treatment and placebo.|Mixed Models Analysis|||MMRM Analysis. The MMRM approach (using REML estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.||1.861|-2.116|0.9
71703813|NCT02384460|142925026|OTHER|Pre-specified.|Odds Ratio (OR)|1.445||||0.262|TWO_SIDED|95.0|0.759|2.752||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in itching versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline itching score, and EB type as covariates.||2.752|0.759|0.262
71703814|NCT02384460|142925027|OTHER|Pre-specified.|Odds Ratio (OR)|0.596||||0.098|TWO_SIDED|95.0|0.323|1.1||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in pain versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline pain score and EB type as covariates.||1.1|0.323|0.098
71703815|NCT01060111|142925028|SUPERIORITY_OR_OTHER|||||||0.6207|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.6207
71703816|NCT01060111|142925028|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferioirity was to be concluded if the ratio of percentage decrease in migraine episodes was greater than 0.7. Power of calculation was 0.9, significance level was 0.025.|Ratio of percentage decrease|0.95||||0.5|TWO_SIDED|95.0|0.519|1.737|||t-test, 1 sided|||||1.737|0.519|0.5
71703817|NCT01060111|142925029|SUPERIORITY_OR_OTHER|||||||0.7247|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.7247
71703818|NCT01060111|142925030|SUPERIORITY_OR_OTHER|||||||0.9872|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.||||||0.9872
71703819|NCT01060111|142925031|SUPERIORITY_OR_OTHER|||||||0.4326||||||Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|ANOVA|||||||0.4326
71703820|NCT00997126|142925037|SUPERIORITY_OR_OTHER|||||||0.657|||||||Chi-squared|||||||0.657
71703821|NCT02122952|142925073|SUPERIORITY||||||<|0.001|||||||One-sided Exact Binomial Test|||Data for the current study were compared to historical control data (Pediatric Neuromuscular Clinical Research \[PNCR\], Finkel et al 2014 - PubMed 25080519) where 0 participants were able to sit independently.||||<0.001
71703822|NCT00896233|142925074|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.81|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.81|
71703823|NCT00896233|142925074|SUPERIORITY_OR_OTHER||ICC|0.85|||||TWO_SIDED|90.0|0.71|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.98|0.71|
71652060|NCT02310763|142822749|SUPERIORITY||Mean Difference (Net)|-0.336||||0.3739|TWO_SIDED|95.0|-1.082|0.41||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 33||0.410|-1.082|0.3739
71652061|NCT02310763|142822749|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4019|TWO_SIDED|95.0|-1.079|0.436||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 49||0.436|-1.079|0.4019
71652062|NCT02310763|142822750|SUPERIORITY||Mean Difference (Net)|-0.107||||0.7676|TWO_SIDED|95.0|-0.825|0.61||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 17||0.610|-0.825|0.7676
71652063|NCT02310763|142822750|SUPERIORITY||Mean Difference (Net)|-0.322||||0.4127|TWO_SIDED|95.0|-1.098|0.454||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 33||0.454|-1.098|0.4127
71652064|NCT02310763|142822750|SUPERIORITY||Mean Difference (Net)|0.113||||0.7815|TWO_SIDED|95.0|-0.693|0.919||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 49||0.919|-0.693|0.7815
71652065|NCT02310763|142822750|SUPERIORITY||Mean Difference (Net)|-0.236||||0.4975|TWO_SIDED|95.0|-0.924|0.451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 17||0.451|-0.924|0.4975
71652066|NCT02310763|142822750|SUPERIORITY||Mean Difference (Net)|-0.467||||0.2646|TWO_SIDED|95.0|-1.294|0.359||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 33||0.359|-1.294|0.2646
71652067|NCT02310763|142822750|SUPERIORITY||Mean Difference (Net)|-0.149||||0.732|TWO_SIDED|95.0|-1.008|0.71||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 49||0.710|-1.008|0.7320
71652068|NCT02310763|142822751|SUPERIORITY||Mean Difference (Net)|-0.044||||0.8569|TWO_SIDED|95.0|-0.525|0.437||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 17||0.437|-0.525|0.8569
71652069|NCT02310763|142822751|SUPERIORITY||Mean Difference (Net)|-0.154||||0.5495|TWO_SIDED|95.0|-0.663|0.355||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 33||0.355|-0.663|0.5495
71703824|NCT00896233|142925074|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.78|
71703825|NCT00896233|142925074|SUPERIORITY_OR_OTHER||ICC|0.86|||||TWO_SIDED|90.0|0.75|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||0.98|0.75|
71703826|NCT00896233|142925075|SUPERIORITY_OR_OTHER||ICC|0.9|||||TWO_SIDED|90.0|0.8|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.80|
71703827|NCT00896233|142925075|SUPERIORITY_OR_OTHER||ICC|0.88|||||TWO_SIDED|90.0|0.78|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.||0.99|0.78|
71886500|NCT04202679|143293367|SUPERIORITY||LS mean difference|-1.61||||0.0003|TWO_SIDED|95.0|-2.49|-0.73||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-0.73|-2.49|0.0003
71652070|NCT02310763|142822751|SUPERIORITY||Mean Difference (Net)|-0.023||||0.934|TWO_SIDED|95.0|-0.566|0.521||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 49||0.521|-0.566|0.9340
71652071|NCT02310763|142822751|SUPERIORITY||Mean Difference (Net)|-0.236||||0.3279|TWO_SIDED|95.0|-0.711|0.239||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 17||0.239|-0.711|0.3279
71652072|NCT02310763|142822751|SUPERIORITY||Mean Difference (Net)|-0.757||||0.0086|TWO_SIDED|95.0|-1.318|-0.196||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 33||-0.196|-1.318|0.0086
71652073|NCT02310763|142822751|SUPERIORITY||Mean Difference (Net)|-0.439||||0.2328|TWO_SIDED|95.0|-1.165|0.286||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 49||0.286|-1.165|0.2328
71652074|NCT02310763|142822752|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.211||||0.8908|TWO_SIDED|95.0|-2.8353|3.2573|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||3.2573|-2.8353|0.8908
71652075|NCT02310763|142822753|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.819||||0.4748|TWO_SIDED|95.0|-1.4514|3.0895|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||3.0895|-1.4514|0.4748
71652076|NCT02310763|142822754|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0097||||0.807|TWO_SIDED|95.0|-0.0692|0.0887|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0.0887|-0.0692|0.8070
71652077|NCT02310763|142822755|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0506||||0.3643|TWO_SIDED|95.0|-0.0594|0.1607|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||0.1607|-0.0594|0.3643
71652078|NCT02310763|142822756|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-2.9||||0.0483|TWO_SIDED|95.0|-5.7|0.0|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||0|-5.7|0.0483
71652079|NCT02310763|142822757|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-3.9||||0.0146|TWO_SIDED|95.0|-7.0|-0.8|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-0.8|-7.0|0.0146
71652080|NCT02310763|142822758|EQUIVALENCE|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-31.6||||0.1669|TWO_SIDED|95.0|-76.9|13.6|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.|||13.6|-76.9|0.1669
71652081|NCT02310763|142822759|SUPERIORITY|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-66.3||||0.0267|TWO_SIDED|95.0|-124.5|-8.1|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.|||-8.1|-124.5|0.0267
71652082|NCT02310763|142822760|SUPERIORITY||Mean Difference (Net)|-0.0692||||0.7033|TWO_SIDED|95.0|-0.4345|0.2961||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.2961|-0.4345|0.7033
71703828|NCT00896233|142925075|SUPERIORITY_OR_OTHER||ICC|0.93|||||TWO_SIDED|90.0|0.87|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.87|
71703829|NCT00896233|142925075|SUPERIORITY_OR_OTHER||ICC|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.||1.00|0.88|
71703830|NCT02965456|142925093|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
71703831|NCT02965456|142925094|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
71703832|NCT02965456|142925095|SUPERIORITY|||||||0.007||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||0.007
71652083|NCT02310763|142822760|SUPERIORITY||Mean Difference (Net)|0.2114||||0.6893|TWO_SIDED|95.0|-0.8472|1.27||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.27|-0.8472|0.6893
71652084|NCT02310763|142822760|SUPERIORITY||Mean Difference (Net)|-2.6439||||0.6469|TWO_SIDED|95.0|-14.4292|9.1414||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||9.1414|-14.4292|0.6469
71703833|NCT04465955|142925112|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.4345|TWO_SIDED|95.0|-0.528|0.227|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q4W and Pooled Sham||0.227|-0.528|0.4345
71703834|NCT04465955|142925112|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.4217|TWO_SIDED|95.0|-0.536|0.225|||Random coefficient model|Covariates included terms for time, treatment-by-time interaction, baseline fellow eye CNV status, baseline focality, and baseline GA lesion location||Rate of Change Difference Between NGM621 Q8W and Pooled Sham||0.225|-0.536|0.4217
71703835|NCT01860404|142925208|SUPERIORITY|||||||0.871|||||||Kruskal-Wallis|||||||0.871
71703836|NCT01860404|142925209|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.140
71762966|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1748|TWO_SIDED|95.0|0.834|2.71||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 3."|||2.710|0.834|0.1748
71652085|NCT02310763|142822761|SUPERIORITY||Mean Difference (Net)|-0.3289||||0.1353|TWO_SIDED|95.0|-0.7649|0.1072||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1072|-0.7649|0.1353
71652086|NCT02310763|142822761|SUPERIORITY||Mean Difference (Net)|0.3457||||0.7648|TWO_SIDED|95.0|-1.9614|2.6528||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||2.6528|-1.9614|0.7648
71652087|NCT02310763|142822761|SUPERIORITY||Mean Difference (Net)|8.2893||||0.3562|TWO_SIDED|95.0|-9.6409|26.2194||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||26.2194|-9.6409|0.3562
71652088|NCT02310763|142822762|SUPERIORITY||Mean Difference (Net)|-0.5582||||0.1163||95.0|-1.2615|0.1451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1451|-1.2615|0.1163
71703837|NCT01860404|142925210|SUPERIORITY|||||||0.267|||||||Kruskal-Wallis|||||||0.267
71703838|NCT01860404|142925211|SUPERIORITY|||||||0.476|||||||Kruskal-Wallis|||||||0.476
71703839|NCT01860404|142925212|SUPERIORITY|||||||0.581|||||||Kruskal-Wallis|||||||0.581
71652089|NCT02310763|142822762|SUPERIORITY||Mean Difference (Net)|0.0944||||0.9503|TWO_SIDED|95.0|-3.0798|3.2686||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2686|-3.0798|0.9503
71703840|NCT01860404|142925213|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
71703841|NCT01860404|142925214|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71703842|NCT01860404|142925215|SUPERIORITY|||||||0.482|||||||Kruskal-Wallis|||||||0.482
71703843|NCT01860404|142925216|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
71703844|NCT01860404|142925217|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||||||0.629
71703845|NCT01860404|142925218|SUPERIORITY|||||||0.624|||||||Regression, Linear|||||||0.624
71703846|NCT01860404|142925219|SUPERIORITY|||||||0.2554|||||||Regression, Linear|||||||0.2554
71703847|NCT01860404|142925220|SUPERIORITY|||||||0.7964|||||||Regression, Linear|||||||0.7964
71703848|NCT01860404|142925221|SUPERIORITY|||||||0.7749|||||||Regression, Linear|||||||0.7749
71703849|NCT01860404|142925222|SUPERIORITY|||||||0.0036|||||||Regression, Linear|||||||0.0036
71652090|NCT02310763|142822762|SUPERIORITY||Mean Difference (Net)|-11.2881||||0.2947|TWO_SIDED|95.0|-32.8328|10.2566||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||10.2566|-32.8328|0.2947
71652091|NCT02310763|142822763|SUPERIORITY||Mean Difference (Net)|0.0159||||0.8229|TWO_SIDED|95.0|-0.127|0.1588||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.1588|-0.1270|0.8229
71652092|NCT02310763|142822763|SUPERIORITY||Mean Difference (Net)|-0.0132||||0.7709|TWO_SIDED|95.0|-0.1036|0.0772||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||0.0772|-0.1036|0.7709
71652093|NCT02310763|142822763|SUPERIORITY||Mean Difference (Net)|0.0889||||0.3746|TWO_SIDED|95.0|-0.1219|0.2996||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.2996|-0.1219|0.3746
71703850|NCT01860404|142925223|SUPERIORITY|||||||0.0053|||||||Regression, Linear|||||||0.0053
71703851|NCT01860404|142925224|SUPERIORITY|||||||0.8234|||||||Regression, Linear|||||||0.8234
71703852|NCT02762604|142925225|SUPERIORITY||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-19.36|15.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in normal pace gait speed pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||15.12|-19.36|
71703853|NCT02762604|142925225|SUPERIORITY||Mean Difference (Net)|17.19|STANDARD_ERROR_OF_MEAN|8.05|||TWO_SIDED|95.0|1.4|32.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait speed during walking while talking pre and post intervention||32.97|1.40|
71703854|NCT02762604|142925226|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|0.21|2.99|||||The estimate parameter reflects change in the number of correct letters generated pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|A linear mixed effects model was used to compare changes in correct letters generated pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.99|0.21|
71703855|NCT02762604|142925227|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|7.37|||TWO_SIDED|95.0|-12.04|16.85|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (Imagined Gait vs. Visual Imagery).|Linear mixed effects model were used to compare changes in the functional activation/deactivation pattern (factor score) during imagery of walking-while talking (relative to walking and talking alone) pre and post intervention - as a function of of intervention (Imagined Gait vs. Visual Imagery)||16.85|-12.04|
71886501|NCT04202679|143293368|SUPERIORITY||LS mean difference|0.54||||0.1658|TWO_SIDED|95.0|-0.22|1.3||Threshold of significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||1.30|-0.22|0.1658
71652094|NCT02310763|142822764|SUPERIORITY||Mean Difference (Net)|-0.0934||||0.2294|TWO_SIDED|95.0|-0.2481|0.0613||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0613|-0.2481|0.2294
71652095|NCT02310763|142822764|SUPERIORITY||Mean Difference (Net)|-0.0117||||0.8485|TWO_SIDED|95.0|-0.1339|0.1105||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.1105|-0.1339|0.8485
71652096|NCT02310763|142822764|SUPERIORITY||Mean Difference (Net)|0.0562||||0.6645|TWO_SIDED|95.0|-0.2187|0.3312||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3312|-0.2187|0.6645
71652097|NCT02310763|142822765|SUPERIORITY||Mean Difference (Net)|-0.1013||||0.2101|TWO_SIDED|95.0|-0.2622|0.0597||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||0.0597|-0.2622|0.2101
71703856|NCT02762604|142925228|SUPERIORITY||Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|6.94|||TWO_SIDED|95.0|-14.15|13.07|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails a time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||13.07|-14.15|
71703857|NCT02762604|142925229|SUPERIORITY||Mean Difference (Net)|-12.21|STANDARD_ERROR_OF_MEAN|20.26|||TWO_SIDED|95.0|-51.92|27.51|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails b time pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.51|-51.92|
71703858|NCT02762604|142925230|SUPERIORITY||Mean Difference (Net)|-10.83|STANDARD_ERROR_OF_MEAN|19.03|||TWO_SIDED|95.0|-48.12|26.47|||||The estimate parameter is the difference in change pre to post intervention between Imagined Gait and Visual Imagery group.|Linear mixed effects model were used to compare changes in trails B minus A time pre and post intervention.||26.47|-48.12|
71825206|NCT00991276|143154642|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|2.25||0.3792|TWO_SIDED|95.0|-6.43|2.47||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||2.47|-6.43|0.3792
71825207|NCT00991276|143154643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.27|STANDARD_ERROR_OF_MEAN|1.66||0.0019|TWO_SIDED|95.0|1.98|8.55||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||8.55|1.98|0.0019
71886502|NCT04202679|143293376|SUPERIORITY||LS mean difference|-0.61||||0.037|TWO_SIDED|95.0|-1.18|-0.04||Threshold of significance was \<0.05.|ANCOVA||Dupilumab 300 mg q2w versus Placebo|||-0.04|-1.18|0.0370
71652098|NCT02310763|142822765|SUPERIORITY||Mean Difference (Net)|-0.0359||||0.4603|TWO_SIDED|95.0|-0.1326|0.0608||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.0608|-0.1326|0.4603
71652099|NCT02310763|142822765|SUPERIORITY||Mean Difference (Net)|0.1039||||0.3739|TWO_SIDED|95.0|-0.1386|0.3463||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||0.3463|-0.1386|0.3739
71652100|NCT02310763|142822766|SUPERIORITY||Mean Difference (Net)|-0.3||||0.8925|TWO_SIDED|95.0|-4.5|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.9|-4.5|0.8925
71652101|NCT02310763|142822766|SUPERIORITY||Mean Difference (Net)|1.2||||0.2107|TWO_SIDED|95.0|-0.7|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.2|-0.7|0.2107
71652102|NCT02310763|142822766|SUPERIORITY||Mean Difference (Net)|1.3||||0.2298|TWO_SIDED|95.0|-0.9|3.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.5|-0.9|0.2298
71652103|NCT02310763|142822767|SUPERIORITY||Mean Difference (Net)|3.5||||0.0554|TWO_SIDED|95.0|-0.1|7.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||7.1|-0.1|0.0554
71652104|NCT02310763|142822767|SUPERIORITY||Mean Difference (Net)|1.6||||0.2027|TWO_SIDED|95.0|-0.9|4.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||4.0|-0.9|0.2027
71652105|NCT02310763|142822767|SUPERIORITY||Mean Difference (Net)|2.9||||0.0926|TWO_SIDED|95.0|-0.5|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||6.3|-0.5|0.0926
71652106|NCT02310763|142822768|SUPERIORITY||Mean Difference (Net)|2.0||||0.3597|TWO_SIDED|95.0|-2.4|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||6.3|-2.4|0.3597
71762967|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0658|TWO_SIDED|95.0|0.964|3.195||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 3."|||3.195|0.964|0.0658
71652107|NCT02310763|142822768|SUPERIORITY||Mean Difference (Net)|0.5||||0.7345|TWO_SIDED|95.0|-2.3|3.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||3.3|-2.3|0.7345
71762968|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0587|TWO_SIDED|95.0|0.979|3.184||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 4."|||3.184|0.979|0.0587
71762969|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.049|TWO_SIDED|95.0|1.003|3.283||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 4."|||3.283|1.003|0.0490
71762970|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.2742|TWO_SIDED|95.0|0.774|2.464||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 4."|||2.464|0.774|0.2742
71762971|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4206|TWO_SIDED|95.0|0.706|2.304||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 5."|||2.304|0.706|0.4206
71762972|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5494|TWO_SIDED|95.0|0.664|2.16||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 5."|||2.160|0.664|0.5494
71825208|NCT00991276|143154643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.25|STANDARD_ERROR_OF_MEAN|1.65||0.0506|TWO_SIDED|95.0|-0.01|6.51||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||6.51|-0.01|0.0506
71825209|NCT00991276|143154643|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.64||0.2222|TWO_SIDED|95.0|-1.24|5.26||This analysis was not included in the step-down procedure (if p-value \< 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.||5.26|-1.24|0.2222
71825210|NCT00711646|143154645|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.517||||0.048|TWO_SIDED|95.0|-1.029|-0.004|||ANCOVA|||The change in mean 11-point Numerical Rating Scale spasticity score was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline 11-point Numerical Rating Scale spasticity score as a covariate.||-0.004|-1.029|0.048
71825211|NCT00711646|143154646|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.218|TWO_SIDED|95.0|-0.29|0.07|||ANCOVA|||The change in mean Ashworth Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Ashworth Scale score as a covariate.||0.07|-0.29|0.218
71825212|NCT00711646|143154647|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.17||||0.141|TWO_SIDED|95.0|-0.39|0.06|||ANCOVA|||The change in mean spasm frequency score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline spasm frequency score as a covariate.||0.06|-0.39|0.141
71825213|NCT00711646|143154648|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.3||||0.766|TWO_SIDED|95.0|-7.47|10.07|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||10.07|-7.47|0.766
71825214|NCT00711646|143154649|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|8.46||||0.349|TWO_SIDED|95.0|-6.74|23.66|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||23.66|-6.74|0.349
71825215|NCT00711646|143154651|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.86||||0.054|TWO_SIDED|95.0|-0.06|7.78|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.||7.78|-0.06|0.054
71825216|NCT01149681|143154656|SUPERIORITY|||||||0.2364|||||||Repeated measures analysis|||||||0.2364
71652108|NCT02310763|142822768|SUPERIORITY||Mean Difference (Net)|4.0||||0.032|TWO_SIDED|95.0|0.4|7.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||7.7|0.4|0.0320
71652109|NCT02310763|142822769|SUPERIORITY||Mean Difference (Net)|1.2||||0.3345|TWO_SIDED|95.0|-1.3|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||3.8|-1.3|0.3345
71652110|NCT02310763|142822769|SUPERIORITY||Mean Difference (Net)|-1.2||||0.14|TWO_SIDED|95.0|-2.9|0.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||0.4|-2.9|0.1400
71825217|NCT00930813|143154677|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.||||0.016
71825218|NCT00315120|143154688|SUPERIORITY_OR_OTHER||Response ratio|2.0||||0.007|TWO_SIDED|95.0|1.2|3.2|||Chi-squared|||||3.2|1.2|0.007
71825219|NCT00315120|143154693|SUPERIORITY_OR_OTHER||Response ratio|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared|||||1.7|0.7|0.72
71652111|NCT02310763|142822769|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6764|TWO_SIDED|95.0|-5.4|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.6|-5.4|0.6764
71652112|NCT02310763|142822770|SUPERIORITY||Mean Difference (Net)|6.5||||0.097|TWO_SIDED|95.0|-1.2|14.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||14.2|-1.2|0.0970
71825220|NCT02145182|143154723|SUPERIORITY||Odds Ratio (OR)|0.81||||0.3983|TWO_SIDED|95.0|0.49|1.33|||Regression, Logistic|Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.|Calculated using the logistic regression model.|Analysis of DGF composite||1.33|0.49|0.3983
71825221|NCT02661997|143154743|SUPERIORITY|||||||0.58||||||Between group differences|ANOVA|||||||0.58
71825222|NCT02661997|143154744|SUPERIORITY|||||||0.88|||||||ANOVA|||||||0.88
71825223|NCT02661997|143154745|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.17
71825224|NCT02661997|143154746|SUPERIORITY|||||||0.88|||||||ANOVA|||This is an analysis of pre to post-treatment changes on the Physical Health subscale of the PROMIS Global Health Scale||||0.88
71825225|NCT02661997|143154747|SUPERIORITY|||||||0.032||||||P-value for group by time interaction|ANOVA|||||||0.032
71825226|NCT02661997|143154748|SUPERIORITY|||||||0.006||||||P-value for group by time interaction|ANOVA|||||||0.006
71825227|NCT02661997|143154749|SUPERIORITY|||||||0.44||||||P-value for group by time interaction|ANOVA|||||||0.44
71825228|NCT02661997|143154750|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
71825229|NCT02661997|143154751|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
71825230|NCT02661997|143154752|SUPERIORITY|||||||0.55||||||P-value for group by time interaction|ANOVA|||||||0.55
71825231|NCT02661997|143154753|SUPERIORITY|||||||0.36||||||P-value for group by time interaction|ANOVA|||||||0.36
71825232|NCT02661997|143154754|SUPERIORITY|||||||0.73||||||P-value for group by time interaction|ANOVA|||||||0.73
71825233|NCT00742274|143154772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71825234|NCT03404843|143154783|OTHER|||||||0.97|||||||ANOVA|||Within group comparison of treatment||||0.97
71825235|NCT03404843|143154783|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
71652113|NCT02310763|142822770|SUPERIORITY||Mean Difference (Net)|-0.3||||0.6919|TWO_SIDED|95.0|-1.9|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||1.3|-1.9|0.6919
71652114|NCT02310763|142822770|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6736|TWO_SIDED|95.0|-5.8|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.9|-5.8|0.6736
71652115|NCT02310763|142822771|SUPERIORITY||Mean Difference (Net)|0.0||||0.9582|TWO_SIDED|95.0|-1.5|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||1.5|-1.5|0.9582
71652116|NCT02310763|142822771|SUPERIORITY||Mean Difference (Net)|-0.1||||0.8629|TWO_SIDED|95.0|-1.8|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<= 8 seconds||1.5|-1.8|0.8629
71652117|NCT02310763|142822771|SUPERIORITY||Mean Difference (Net)|-0.9||||0.6746|TWO_SIDED|95.0|-5.5|3.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||3.7|-5.5|0.6746
71652118|NCT02310763|142822772|SUPERIORITY||Mean Difference (Net)|-5.8||||0.7483|TWO_SIDED|95.0|-42.4|30.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||30.7|-42.4|0.7483
71652119|NCT02310763|142822772|SUPERIORITY||Mean Difference (Net)|-1.3||||0.9053|TWO_SIDED|95.0|-23.9|21.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||21.2|-23.9|0.9053
71652120|NCT02310763|142822772|SUPERIORITY||Mean Difference (Net)|13.1||||0.6896|TWO_SIDED|95.0|-53.4|79.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||79.7|-53.4|0.6896
71652121|NCT02310763|142822773|SUPERIORITY||Mean Difference (Net)|-3.7||||0.8117|TWO_SIDED|95.0|-34.8|27.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||27.5|-34.8|0.8117
71652122|NCT02310763|142822773|SUPERIORITY||Mean Difference (Net)|7.3||||0.6018|TWO_SIDED|95.0|-20.6|35.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||35.2|-20.6|0.6018
71825236|NCT03404843|143154784|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
71825237|NCT03404843|143154784|OTHER||||||<|0.05|||||||ANOVA|||Within group comparison of treatment||||<0.05
71825238|NCT03404843|143154785|OTHER|||||||0.28|||||||ANOVA|||Within group comparison of treatment||||0.28
71825239|NCT03404843|143154785|OTHER|||||||0.37|||||||ANOVA|||Within group comparison of treatment||||0.37
71652123|NCT02310763|142822773|SUPERIORITY||Mean Difference (Net)|16.3||||0.7152|TWO_SIDED|95.0|-73.4|106.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||106.0|-73.4|0.7152
71652124|NCT02310763|142822774|SUPERIORITY||Mean Difference (Net)|7.0||||0.719|TWO_SIDED|95.0|-32.1|46.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\<3.5 seconds||46.1|-32.1|0.7190
71652125|NCT02310763|142822774|SUPERIORITY||Mean Difference (Net)|-15.8||||0.4634|TWO_SIDED|95.0|-58.9|27.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>=3.5 and \<=8 seconds||27.3|-58.9|0.4634
71652126|NCT02310763|142822774|SUPERIORITY||Mean Difference (Net)|3.9||||0.94|TWO_SIDED|95.0|-100.7|108.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC\>8 seconds||108.5|-100.7|0.9400
71825240|NCT03404843|143154786|OTHER|||||||0.89|||||||ANOVA|||Within group comparison of treatment||||0.89
71825241|NCT03404843|143154786|OTHER|||||||0.3|||||||ANOVA|||Within group comparison of treatment||||0.30
71825242|NCT03404843|143154787|OTHER|||||||0.08|||||||ANOVA|||Within group comparison of treatment||||0.08
71825243|NCT03404843|143154787|OTHER|||||||0.05|||||||ANOVA|||Within group comparison of treatment||||0.05
71825244|NCT00320489|143154788|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||Log Rank|||||||0.612
71652127|NCT02310763|142822778|SUPERIORITY||Mean Difference (Net)|2.945||||0.0087|TWO_SIDED|95.0|0.7597|5.1309||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||5.1309|0.7597|0.0087
71652128|NCT02310763|142822778|SUPERIORITY||Mean Difference (Net)|2.918||||0.0536|TWO_SIDED|95.0|-0.0461|5.8811||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.8811|-0.0461|0.0536
71652129|NCT02310763|142822778|SUPERIORITY||Mean Difference (Net)|4.087||||0.0298|TWO_SIDED|95.0|0.4069|7.7677||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||7.7677|0.4069|0.0298
71825245|NCT00320489|143154789|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||P-Value is for change from baseline at Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.649
71825246|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for change at Week 104 in Mental Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.744
71825247|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for change at Week 104 in Physical Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.653
71825248|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||P-value for change at Week 104 in Physical Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.640
71825249|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.454||95.0||||P-value for change at Week 104 in Role-Physical.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.454
71825250|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||P-value for change at Week 104 in Bodily Pain.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.135
71825251|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||P-value for change at Week 104 in General Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.229
71703859|NCT02762604|142925231|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.65|0.79|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in correct letter number sequences pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.79|-2.65|
71703860|NCT02762604|142925232|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|12.95|||TWO_SIDED|95.0|-24.0|26.78|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in Stroop interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||26.78|-24.00|
71703861|NCT02762604|142925233|SUPERIORITY||Mean Difference (Net)|6.76|STANDARD_ERROR_OF_MEAN|79.95|||TWO_SIDED|95.0|-149.94|163.47|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in flanker interference pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||163.47|-149.94|
71703862|NCT02762604|142925234|SUPERIORITY||Mean Difference (Net)|15.2|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|5.99|24.41|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in stride length during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||24.41|5.99|
71703863|NCT02762604|142925235|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.73|-0.2|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in gait variability during walking while talking pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||-0.20|-3.73|
71703864|NCT02762604|142925237|SUPERIORITY||Mean Difference (Net)|2.43|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-5.98|10.84|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in total free recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||10.84|-5.98|
71703865|NCT02762604|142925238|SUPERIORITY||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-5.88|2.0|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed figure copy recall pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.00|-5.88|
71703866|NCT02762604|142925239|SUPERIORITY||Mean Difference (Net)|-6.36|STANDARD_ERROR_OF_MEAN|6.96|||TWO_SIDED|95.0|-20.01|7.28|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in word fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||7.28|-20.01|
71703867|NCT02762604|142925240|SUPERIORITY||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|-6.51|17.97|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in semantic fluency pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||17.97|-6.51|
71703868|NCT02762604|142925241|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-16.1|16.03||||||A linear mixed effects model was used to compare changes in digit symbol substitution performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)|The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|16.03|-16.10|
71825252|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value for change at Week 104 in Vitality.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.594
71703869|NCT02762604|142925243|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|7.54|||TWO_SIDED|95.0|-11.14|18.42|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in immediate maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||18.42|-11.14|
71703870|NCT02762604|142925244|SUPERIORITY||Mean Difference (Net)|3.26|STANDARD_ERROR_OF_MEAN|12.2|||TWO_SIDED|95.0|-20.65|27.18|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in delayed maze performance pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||27.18|-20.65|
71703871|NCT02762604|142925245|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.45|0.9|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in maze errors pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.90|-0.45|
71825253|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||P-value for change at Week 104 in Social Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.256
71825254|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||P-value for change at Week 104 in Role-Emotional.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.775
71825255|NCT00320489|143154790|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||P-value for change at Week 104 in Mental Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.781
71825256|NCT00320489|143154791|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.465
71825257|NCT00320489|143154792|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.581
71886503|NCT02066792|143293393|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.81|-0.21||two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||At 3 month follow-up||-.21|-.81|<.001
71825258|NCT00320489|143154795|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|P-value is type III p-value of ANOVA model: Total number of hospitalization days = Therapy.||||||0.020
71825259|NCT00320489|143154796|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-value is for Total Score (Items 1-5) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.583
71825260|NCT00320489|143154796|SUPERIORITY_OR_OTHER|||||||0.747||95.0||||P-value is for Total Score (Items 1-4) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.747
71825261|NCT00320489|143154797|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.||||||0.371
71825262|NCT00320489|143154798|SUPERIORITY_OR_OTHER|||||||0.681||95.0||||P-value is fro change from baseline to Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.681
71825263|NCT00320489|143154799|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for overall satisfaction with current medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.60
71825264|NCT00320489|143154799|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for preference current/previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit||||||.258
71825265|NCT00320489|143154799|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-value is for side effects - current vs previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.492
71825266|NCT00320489|143154800|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy\*Visit.||||||0.854
71825267|NCT00320489|143154801|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||||||0.600
71825268|NCT00320489|143154802|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.282
71652130|NCT02310763|142822779|SUPERIORITY||Mean Difference (Net)|1.575||||0.0684|TWO_SIDED|95.0|-0.1213|3.2715||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17||3.2715|-0.1213|0.0684
71652131|NCT02310763|142822779|SUPERIORITY||Mean Difference (Net)|2.612||||0.0376|TWO_SIDED|95.0|0.1521|5.0711||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33||5.0711|0.1521|0.0376
71825269|NCT00320489|143154803|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for PANSS Total Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.834
71825270|NCT00320489|143154803|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||P-value is for PANSS Positive Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.871
71825271|NCT00320489|143154803|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||P-value is for PANSS Negative Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.692
71825272|NCT00320489|143154803|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for PANSS General Psychopathology Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit, Baseline.||||||0.893
71825273|NCT00320489|143154804|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||Log Rank|||||||0.585
71825274|NCT00320489|143154805|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||Fisher Exact|||||||0.659
71825275|NCT00320489|143154806|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy\*Visit Baseline.||||||0.952
71825276|NCT00320489|143154808|SUPERIORITY_OR_OTHER|||||||0.777||95.0||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = baseline, treatment, and investigator.||||||0.777
71825277|NCT00320489|143154809|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Fisher Exact|||||||0.530
71825278|NCT00320489|143154810|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value for fasting glucose.|Fisher Exact|||||||0.258
71825279|NCT00320489|143154810|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for fasting total cholesterol.|Fisher Exact|||||||0.688
71825280|NCT00320489|143154810|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||P-value is for fasting triglycerides.|Fisher Exact|||||||0.908
71825281|NCT00320489|143154811|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||Fisher Exact|||||||0.835
71825282|NCT00320489|143154812|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for ALT.|Fisher Exact|||||||0.834
71825283|NCT00320489|143154812|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||P-value is for AST.|Fisher Exact|||||||0.723
71825284|NCT00320489|143154812|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||P-value is for total bilirubin.|Fisher Exact|||||||0.247
71825285|NCT00320489|143154813|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Fisher Exact|||||||0.885
71825286|NCT03441984|143154814|OTHER||Ratio of geometric LS means|1.6946|||||TWO_SIDED|90.0|1.569|1.8373|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented|||1.8373|1.5690|
71825287|NCT03441984|143154814|OTHER||Ratio of geometric LS means|1.3512|||||TWO_SIDED|90.0|1.2465|1.4647|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4647|1.2465|
71825288|NCT03441984|143154814|OTHER||Ratio of geometric LS means|1.2541|||||TWO_SIDED|90.0|1.1569|1.3595|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented|||1.3595|1.1569|
71825289|NCT03441984|143154815|OTHER||Ratio of geometric LS means|1.7001|||||TWO_SIDED|90.0|1.5685|1.8428|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8428|1.5685|
71825290|NCT03441984|143154815|OTHER||Ratio of geometric LS means|1.3519|||||TWO_SIDED|90.0|1.2475|1.465|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4650|1.2475|
71825291|NCT03441984|143154815|OTHER||Ratio of geometric LS means|1.2576|||||TWO_SIDED|90.0|1.1605|1.3629|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3629|1.1605|
71652132|NCT02310763|142822779|SUPERIORITY||Mean Difference (Net)|3.208||||0.0411|TWO_SIDED|95.0|0.1318|6.2844||The significance level is 0.05|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49||6.2844|0.1318|0.0411
71652133|NCT03877926|142822800|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 2 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|0.93|
71652134|NCT03877926|142822800|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 1 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.05|||||TWO_SIDED|95.0|0.96|1.14||||||||1.14|0.96|
71652135|NCT03877926|142822800|EQUIVALENCE|The 95% CIs for the Day 64 TNA NF50 GMT ratios between AV7909 Lot 2 and Lot 3 had to be within 0.5 to 2.0 equivalence margin.|Ratio|1.04|||||TWO_SIDED|95.0|0.95|1.13||||||||1.13|0.95|
71652136|NCT03877926|142822802|OTHER||Percentage of participants|66.3|||||TWO_SIDED|95.0|64.5|68.1||||||||68.1|64.5|
71652137|NCT03877926|142822803|NON_INFERIORITY|A non-inferiority margin of -15% was used for the difference in percentage of AV7909 participants (pooled from three AV7909 study groups \[Lot 1, 2, and 3\]) vs. BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. The success criterion was defined as the lower bound of 95% confidence interval of the difference in the percentage of AV7909 vs. BioThrax participants being greater than -15%.|Difference in percentage|24.5|||||TWO_SIDED|95.0|20.0|29.2||||||||29.2|20.0|
71652138|NCT03877926|142822804|OTHER|Relative risk of serious adverse events incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|2.5|||||TWO_SIDED|95.0|0.9|6.5|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||6.5|0.9|
71652139|NCT03877926|142822805|OTHER|Success criteria was defined as the lower bound for the 95% CI for the proportion of participants pooled from all three AV7909 study groups with TNA NF50 ≥0.15 to be ≥67%.|Percentage of participants|97.8|||||TWO_SIDED|95.0|97.2|98.3||||||||98.3|97.2|
71652140|NCT03877926|142822807|OTHER|Relative risk of adverse events of special interest (events of autoimmune etiology) incidence between AV7909 (combined from all three AV7909 lots) and BioThrax.|Relative risk (AV7909/BioThrax)|1.3|||||TWO_SIDED|95.0|0.3|5.0|||||The 95% CI of the relative risk was derived using the Farrington-Manning relative risk score statistic.|||5.0|0.3|
71652141|NCT02240186|142822810|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71652142|NCT02240186|142822811|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71652143|NCT02240186|142822812|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71652144|NCT01352182|142822827|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71652145|NCT01352182|142822828|SUPERIORITY|||||||1||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||1.0
71652146|NCT01352182|142822829|SUPERIORITY|||||||0.154||||||threshold for significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.154
71652147|NCT01352182|142822830|SUPERIORITY|||||||0.683||||||significance threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.683
71652148|NCT01352182|142822831|SUPERIORITY|||||||0.08||||||significance threshold p\<0.05|t-test, 2 sided|||||||0.08
71652149|NCT01352182|142822832|OTHER|linear regression|Slope|-1.44|STANDARD_ERROR_OF_MEAN|0.3741||0.003|TWO_SIDED||||||Regression, Linear|||||||0.003
71652150|NCT02776553|142822843|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
71652151|NCT02776553|142822844|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71652152|NCT02776553|142822845|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
71652153|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a responder rate (π) of 63% in the reference group, a clinically relevant delta (Δ) of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.0986|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.0986
71652154|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.5682|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.5682
71652155|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.8543|TWO_SIDED|5.0|-0.363|0.0284||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.8543
71652156|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.9167|TWO_SIDED|95.0|-0.363|0.0284||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0284|-0.3630|0.9167
71652157|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.6052|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.6052
71703872|NCT02762604|142925246|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.74|2.26|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in depressive symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||2.26|-1.74|
71703873|NCT02762604|142925247|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-3.38|1.49|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in anxiety symptoms pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||1.49|-3.38|
71703874|NCT02762604|142925248|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.04|0.12|||||The estimate parameter reflects the difference in pre to post change between Imagined Gait and Visual Imagery groups.|A linear mixed effects model was used to compare changes in cortical thickness pre and post intervention - as a function of intervention (Imagined Gait vs. Visual Imagery)||0.12|-0.04|
71703875|NCT06038643|142925251|OTHER||||||<|0.001||||||Adjusted for multiple comparisons using False Discovery Rate.|Wilcoxon (Mann-Whitney)|||||||<0.001
71703876|NCT06038643|142925254|SUPERIORITY||||||<|0.01|||||||ANCOVA|||We conducted one-way analyses of covariance (ANCOVAs) to assess the effect of group (intervention vs. control) on post-intervention secondary outcomes, including cognition (Test My Brain Digital Neuropsychology Toolkit). Covariates in all models included age, sex, years of education, APOE4 status, and baseline scores.||||<0.01
71703877|NCT00762177|142925266|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703878|NCT00762177|142925267|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703879|NCT00762177|142925268|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703880|NCT00762177|142925269|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703881|NCT00762177|142925270|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703882|NCT00762177|142925271|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703883|NCT00762177|142925272|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703884|NCT00762177|142925273|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar||||0.05
71703885|NCT00762177|142925274|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703886|NCT00762177|142925275|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703887|NCT00762177|142925276|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703888|NCT00762177|142925277|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703889|NCT00762177|142925278|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703890|NCT00762177|142925279|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71762973|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7586|TWO_SIDED|95.0|0.609|1.975||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 5."|||1.975|0.609|0.7586
71762974|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1946|TWO_SIDED|95.0|0.816|2.717||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 6."|||2.717|0.816|0.1946
71762975|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.538|TWO_SIDED|95.0|0.667|2.174||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 6."|||2.174|0.667|0.5380
71762976|NCT00947882|143027366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.4263|TWO_SIDED|95.0|0.702|2.308||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (\<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 6."|||2.308|0.702|0.4263
71762977|NCT00947882|143027367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76||||0.4607|TWO_SIDED|95.0|-10.113|4.59||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||4.590|-10.113|0.4607
71762978|NCT00947882|143027367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24||||0.3876|TWO_SIDED|95.0|-10.614|4.128||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||4.128|-10.614|0.3876
71703891|NCT00762177|142925280|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703892|NCT00762177|142925281|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703893|NCT00762177|142925282|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703894|NCT00762177|142925283|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703895|NCT00762177|142925284|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703896|NCT00762177|142925285|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703897|NCT00762177|142925286|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71762979|NCT00947882|143027367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28||||0.2548|TWO_SIDED|95.0|-11.65|3.096||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||3.096|-11.650|0.2548
71762980|NCT00947882|143027367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.5652|TWO_SIDED|95.0|-9.729|5.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||5.322|-9.729|0.5652
71762981|NCT00947882|143027367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.7502|TWO_SIDED|95.0|-8.768|6.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||6.322|-8.768|0.7502
71762982|NCT00947882|143027367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.6089|TWO_SIDED|95.0|-9.513|5.581||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||5.581|-9.513|0.6089
71762983|NCT00947882|143027368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.8511|TWO_SIDED|95.0|-1.068|1.294||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|||1.294|-1.068|0.8511
71762984|NCT00947882|143027368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.6331|TWO_SIDED|95.0|-0.9|1.477||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|||1.477|-0.900|0.6331
71762985|NCT00947882|143027368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.909|TWO_SIDED|95.0|-1.113|1.25||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|||1.250|-1.113|0.9090
71762986|NCT00947882|143027368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.5469|TWO_SIDED|95.0|-0.956|1.802||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|||1.802|-0.956|0.5469
71762987|NCT00947882|143027368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.7906|TWO_SIDED|95.0|-1.576|1.2||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|||1.200|-1.576|0.7906
71762988|NCT00947882|143027368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.5757|TWO_SIDED|95.0|-1.773|0.987||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (\<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|||0.987|-1.773|0.5757
71762989|NCT00329797|143027369|SUPERIORITY|||||||0.95|||||||Log Rank|||The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.||||0.95
71762990|NCT00329797|143027370|SUPERIORITY||||||<|0.0001||||||significance level = 0.05|t-test, 2 sided|||Lumbar||||<0.0001
71762991|NCT00329797|143027370|SUPERIORITY|||||||0.47||||||significance level = 0.05|t-test, 2 sided|||Hip - right||||0.47
71762992|NCT00329797|143027370|SUPERIORITY|||||||0.0002||||||significance level = 0.05|t-test, 2 sided|||Hip - left||||0.0002
71762993|NCT00329797|143027370|SUPERIORITY|||||||0.076||||||significance level = 0.05|t-test, 2 sided|||Femoral - right||||0.076
71762994|NCT00329797|143027370|SUPERIORITY|||||||0.0007||||||significance level = 0.05|t-test, 2 sided|||Femoral - left||||0.0007
71762995|NCT00329797|143027371|SUPERIORITY|||||||0.33||||||significance level = 0.01|t-test, 2 sided|||Physical subscale||||0.33
71762996|NCT00329797|143027371|SUPERIORITY|||||||0.82||||||significance level = 0.01|t-test, 2 sided|||Social subscale||||0.82
71703898|NCT00762177|142925287|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703899|NCT00762177|142925288|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703900|NCT00762177|142925289|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71703901|NCT05259033|142925321|SUPERIORITY|Responses were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Estimated treatment difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.33|||ANCOVA|||Treatment policy strategy||-0.33|-0.56|<0.0001
71703902|NCT01405911|142925332|OTHER||Difference in Least Squares Means|-7.11|||<|0.001|TWO_SIDED|95.0|-9.85|-4.36|||Constrained Longitudinal Data Analysis|||||-4.36|-9.85|<0.001
71703903|NCT01405911|142925332|OTHER||Difference in Least Squares Means|-9.08|||<|0.001|TWO_SIDED|95.0|-11.82|-6.33|||Constrained Longitudinal Data Analysis|||||-6.33|-11.82|<0.001
71703904|NCT01405911|142925332|OTHER||Difference in Least Squares Means|-1.97||||0.143|TWO_SIDED|95.0|-4.61|0.67|||Constrained Longitudinal Data Analysis|||||0.67|-4.61|0.143
71703905|NCT01405911|142925333|OTHER||Difference in Least Squares Means|-17.7|||<|0.001|TWO_SIDED|95.0|-21.55|-13.86|||Constrained Longitudinal Data Analysis|||||-13.86|-21.55|<0.001
71703906|NCT01405911|142925333|OTHER||Difference in Least Squares Means|-16.41|||<|0.001|TWO_SIDED|95.0|-20.32|-12.5|||Constrained Longitudinal Data Analysis|||||-12.50|-20.32|<0.001
71703907|NCT01405911|142925333|OTHER||Difference in Least Squares Means|1.3||||0.469|TWO_SIDED|95.0|-2.22|4.82|||Constrained Longitudinal Data Analysis|||||4.82|-2.22|0.469
71703908|NCT05762744|142925348|OTHER|Unpaired two-tailed t-test to test null hypothesis||||||0.37||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: the order of FSIGTs (saline or exenatide-stimulated) does not affect the response during an FSIGT||||0.37
71703909|NCT05762744|142925349|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.66|||||||t-test, 2 sided|||Null hypothesis: The order of FSIGT (exenatide-stimulated or saline) does not affect the response to an FSIGT.||||0.66
71703910|NCT05762744|142925350|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.55|||||||t-test, 2 sided|||Null hypothesis: the order of testing (exenatide-stimulated or saline FSIGT) does not affect data obtained in the FSIGTs.||||0.55
71703911|NCT05762744|142925351|OTHER|Unpaired, two-tailed t-test to test the null hypothesis||||||0.45|||||||t-test, 2 sided|||The order of FSIGTs (exenatide-stimulated or saline) does not affect the response during an FSIGT||||0.45
71762997|NCT00329797|143027371|SUPERIORITY|||||||0.51||||||significance level = 0.01|t-test, 2 sided|||Emotional subscale||||0.51
71762998|NCT00329797|143027371|SUPERIORITY|||||||0.25||||||significance level = 0.01|t-test, 2 sided|||Functional subscale||||0.25
71762999|NCT00329797|143027371|SUPERIORITY|||||||0.63||||||significance level = 0.01|t-test, 2 sided|||Total||||0.63
71763000|NCT00800254|143027400|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71763001|NCT00800254|143027402|SUPERIORITY_OR_OTHER||||||<|0.003|TWO_SIDED||||||ANCOVA|||||||<0.003
71703912|NCT05762744|142925352|OTHER|Two-tailed unpaired t-test to test null hypothesis||||||0.86||||||The t-test was conducted on the logarithms of the variable|t-test, 2 sided|||Null hypothesis: the order of FSIGT (exenatide or saline) does not affect the response during an FSIGT||||0.86
71703913|NCT05762744|142925353|OTHER|Two-tailed p-test for unpaired data||||||0.44||||||The t-test was conducted on the logarithms of the variable.|t-test, 2 sided|||Null hypothesis: The order of FSIGTs (exenatide-stimulated or saline) does not affect the response to an FSIGT||||0.44
71763002|NCT01057589|143027416|SUPERIORITY_OR_OTHER|||||||0.697||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.697
71763003|NCT01057589|143027416|SUPERIORITY_OR_OTHER|||||||0.132||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.132
71763004|NCT01057589|143027417|SUPERIORITY_OR_OTHER|||||||0.223||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.223
71703914|NCT05762744|142925354|OTHER|||||||0.41|||||||t-test, 2 sided|||"Null hypothesis: no differences between the two groups with respect to exenatide's effect on first-phase insulin secretion.~t-test conducted on logarithms of the values"||||0.41
71703915|NCT05762744|142925354|OTHER|||||||0.38|||||||t-test, 2 sided|||Null hypothesis: no difference between two groups with respect to exenatide's effect on first phase insulin secretion||||0.38
71703916|NCT05762744|142925355|OTHER|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance||||0.80
71703917|NCT05762744|142925355|OTHER|||||||0.98|||||||t-test, 2 sided|||Null hypothesis: the two genotype groups do not differ with respect to the effect of exenatide on the rate of glucose disappearance during an FSIGT||||0.98
71703918|NCT01560416|142925376|SUPERIORITY|||||||0.79|||||||Log Rank|||||||0.79
71703919|NCT01560416|142925378|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
71703920|NCT03738215|142925390|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.005|TWO_SIDED|95.0|-4.17|-0.89||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.89|-4.17|0.0050
71703921|NCT03738215|142925390|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0727|TWO_SIDED|95.0|-3.16|0.12||Adjusted P-Value (based on truncated Hochberg with parameter=0.9)|MMRM|MMRM = mixed-effects model for repeated measures||||0.12|-3.16|0.0727
71703922|NCT03738215|142925391|SUPERIORITY||Lease Squares Mean Difference|-0.3||||0.0727|TWO_SIDED|95.0|-0.49|-0.07||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures||||-0.07|-0.49|0.0727
71763005|NCT01057589|143027417|SUPERIORITY_OR_OTHER|||||||0.788||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.788
71763006|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.90
71763007|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.31||||||P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.31
71825292|NCT03441984|143154816|OTHER||Ratio of geometric LS means|1.7382|||||TWO_SIDED|90.0|1.5983|1.8904|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8904|1.5983|
71825293|NCT03441984|143154816|OTHER||Ratio of geometric LS means|1.3614|||||TWO_SIDED|90.0|1.2525|1.4798|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4798|1.2525|
71825294|NCT03441984|143154816|OTHER||Ratio of geometric LS means|1.2768|||||TWO_SIDED|90.0|1.1746|1.3878|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3878|1.1746|
71825295|NCT03441984|143154817|OTHER||Ratio of geometric LS means|1.0407|||||TWO_SIDED|90.0|1.0118|1.0704|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0704|1.0118|
71825296|NCT03441984|143154817|OTHER||Ratio of geometric LS means|1.0228|||||TWO_SIDED|90.0|0.9944|1.052|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0520|0.9944|
71652158|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.5369|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.5369
71825297|NCT03441984|143154817|OTHER||Ratio of geometric LS means|1.0175|||||TWO_SIDED|90.0|0.9893|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9893|
71763008|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.49||||||P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.49
71652159|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.7732|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.7732
71652160|NCT01682148|142822851|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.1758|TWO_SIDED|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.3362|-0.1948|0.1758
71652161|NCT01682148|142822853|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.1324||||0.24|TWO_SIDED|95.0|-0.3531|0.0884||Based on a generalised linear model including factors for treatment, spasticity pattern, country and MAS baseline score.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.||0.0884|-0.3531|0.2400
71652162|NCT01682148|142822854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9448|TWO_SIDED|95.0|||||ANOVA|Analysis of variance (ANOVA) included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 4.||||0.9448
71652163|NCT01682148|142822854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5458|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 12.||||0.5458
71652164|NCT01682148|142822855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4006|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country.||||||0.4006
71763009|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.95||||||P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.95
71825298|NCT03441984|143154818|OTHER||Ratio of geometric LS means|1.041|||||TWO_SIDED|90.0|1.0121|1.0708|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0708|1.0121|
71825299|NCT03441984|143154818|OTHER||Ratio of geometric LS means|1.0232|||||TWO_SIDED|90.0|0.9948|1.0524|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0524|0.9948|
71763010|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.89||||||P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.89
71763011|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.36||||||P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.36
71763012|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.18
71763013|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.47||||||P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.47
71763014|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
71763015|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.45||||||P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.45
71763016|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.29
71652165|NCT01682148|142822856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|||||||Mann-Whitney U-test|||||||0.5747
71652166|NCT01682148|142822857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1802|||||||Mann-Whitney U-test|||||||0.1802
71652167|NCT04740931|142822880|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.6|-2.5|
71652168|NCT04740931|142822880|SUPERIORITY||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6715|TWO_SIDED|95.0|-2.5|1.6||Tested at a two-sided p\<0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept (at a two-sided 0.0497 significance level).||1.6|-2.5|0.6715
71652169|NCT04740931|142822882|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-8.4|5.3||||||||5.3|-8.4|
71652170|NCT04740931|142822898|OTHER||Difference in Adjusted Means|-1.2|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.7|0.3||||||||0.3|-2.7|
71652171|NCT01103479|142822947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65||||0.32|TWO_SIDED|95.0|0.62|4.38||Random effects model adjusting for clustering by clinic|Mixed Models Analysis|||||4.38|0.62|0.32
71652172|NCT01103479|142822948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.28|TWO_SIDED|95.0|0.53|1.2||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.20|0.53|0.28
71652173|NCT01103479|142822949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.42|TWO_SIDED|95.0|0.6|3.43||Random effects model adjusted for clustering by clinic|Mixed Models Analysis|||||3.43|0.60|0.42
71652174|NCT01103479|142822950|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05||||0.38|TWO_SIDED|95.0|0.94|1.18||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis|||||1.18|0.94|0.38
71652175|NCT00605917|142822953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders."||||<0.001
71652176|NCT00605917|142822954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.002
71652177|NCT00605917|142822955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders."||||0.032
71652178|NCT00605917|142822956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders."||||<0.001
71652179|NCT00605917|142822957|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
71652180|NCT00605917|142822958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders."||||0.001
71652181|NCT00605917|142822959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders."||||0.028
71652182|NCT00605917|142822960|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
71652183|NCT00605917|142822961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|Chi-squared|not adjusted, p=0.050||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||0.030
71763017|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.17
71652184|NCT00605917|142822962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.013
71652185|NCT00605917|142822963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.004
71652186|NCT00605917|142822964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders."||||0.004
71763018|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.70
71652187|NCT00438659|142822999|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71660979|NCT03970837|142835410|SUPERIORITY||Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.66|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.66|0.34|<0.0001
71660980|NCT03970837|142835414|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-14.7|||||TWO_SIDED|95.0|-21.3|-8.1|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-8.1|-21.3|
71660981|NCT03970837|142835414|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 95% Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Difference in Percentage|-17.2|||||TWO_SIDED|95.0|-23.9|-10.6|||Regression, Logistic|Difference in proportion and 95% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-10.6|-23.9|
71660982|NCT04568031|142835614|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71660983|NCT04568031|142835614|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71660984|NCT04568031|142835619|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71703923|NCT03738215|142925391|SUPERIORITY||Least Squares Mean Difference|-0.2||||0.0944|TWO_SIDED|95.0|-0.39|0.03||Adjusted P-Value (based on Hochberg procedure)|MMRM|MMRM = mixed-effects model for repeated measures.||||0.03|-0.39|0.0944
71703924|NCT03277274|142925408|OTHER|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.579|||||||ANOVA|||||||0.579
71703925|NCT03277274|142925408|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.026|||||||ANOVA|||||||0.026
71703926|NCT03277274|142925408|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.02|||||||ANOVA|||||||0.020
71703927|NCT03277274|142925408|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.031|||||||ANOVA|||||||0.031
71660985|NCT04568031|142835619|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71660986|NCT04568031|142835622|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71660987|NCT04568031|142835622|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71660988|NCT04430855|142835626|SUPERIORITY||Response Rate Difference|13.3||||0.018|TWO_SIDED|95.0|-0.6|27.2|||Chi-squared||Response rate difference compared to historical placebo = upadacitinib 30 mg - historical placebo|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved HiSCR response to that of a prespecified, single historical placebo rate (25%). The historical placebo rate of 25% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||27.2|-0.6|0.018
71660989|NCT04430855|142835626|SUPERIORITY||Adjusted Response Rate Difference|9.2||||0.142|TWO_SIDED|95.0|-7.6|25.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo HiSCR data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic HiSCR was 29.2%.||25.9|-7.6|0.142
71660990|NCT04430855|142835626|SUPERIORITY||Adjusted Response Rate Difference|14.7||||0.087|TWO_SIDED|95.0|-6.6|36.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved HiSCR at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||36.0|-6.6|0.087
71660991|NCT04430855|142835627|SUPERIORITY||Response Rate Difference|13.9||||0.028|TWO_SIDED|95.0|-2.5|30.3|||Chi-squared||Response rate difference compared to historical placebo (upadacitinib 30 mg - historical placebo)|The primary analysis compared the percentage of participants in the upadacitinib 30 mg treatment group who achieved NRS30 response to that of a prespecified, single historical placebo rate (22.5%). The historical placebo rate of 22.5% was assumed based on the corresponding response rates of placebo participants satisfying the same key eligibility criteria from the 2 adalimumab HS Phase 3 studies, Study M11-313 (NCT01468207) and Study M11-810 (NCT01468233).||30.3|-2.5|0.028
71763019|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.21||||||P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.21
71703928|NCT03277274|142925409|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.151|||||||ANOVA|||||||0.151
71703929|NCT03277274|142925409|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.017|||||||ANOVA|||||||0.017
71703930|NCT03277274|142925409|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.129|||||||ANOVA|||||||0.129
71703931|NCT03277274|142925409|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
71825300|NCT03441984|143154818|OTHER||Ratio of geometric LS means|1.0174|||||TWO_SIDED|90.0|0.9892|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0465|0.9892|
71825301|NCT03441984|143154819|OTHER||Ratio of geometric LS means|1.0533|||||TWO_SIDED|90.0|0.9885|1.1223|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.1223|0.9885|
71825302|NCT03441984|143154819|OTHER||Ratio of geometric LS means|0.9766|||||TWO_SIDED|90.0|0.9167|1.0405|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0405|0.9167|
71825303|NCT03441984|143154819|OTHER||Ratio of geometric LS means|1.0785|||||TWO_SIDED|90.0|1.0123|1.149|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1490|1.0123|
71703932|NCT03277274|142925410|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.138|||||||ANOVA|||||||0.138
71652188|NCT03535857|142823030|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.546|TWO_SIDED|95.0|||||Pairwise t- test|||||||0.546
71652189|NCT01730040|142823039|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.1|||<|0.0001|TWO_SIDED|99.0|-55.9|-22.2|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-22.2|-55.9|< 0.0001
71652190|NCT01730040|142823039|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||=|0.0004|TWO_SIDED|99.0|-40.7|-6.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-6.5|-40.7|= 0.0004
71652191|NCT01730040|142823039|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|99.0|-65.0|-33.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-33.5|-65|< 0.0001
71652192|NCT01730040|142823039|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-48.4|-16.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.9|-48.4|< 0.0001
71652193|NCT01730040|142823039|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|99.0|-47.4|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-47.4|<0.0001
71652194|NCT01730040|142823040|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.5|||<|0.0001|TWO_SIDED|99.0|-59.2|-25.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.||-25.7|-59.2|< 0.0001
71703933|NCT03277274|142925410|OTHER|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.029|||||||ANOVA|||||||0.029
71825304|NCT03441984|143154820|OTHER||Ratio of geometric LS means|1.0|||||TWO_SIDED|90.0|0.9536|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9536|
71825305|NCT03441984|143154820|OTHER||Ratio of geometric LS means|0.9478|||||TWO_SIDED|90.0|0.9039|0.9939|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9939|0.9039|
71825306|NCT03441984|143154820|OTHER||Ratio of geometric LS means|1.055|||||TWO_SIDED|90.0|1.0061|1.1063|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1063|1.0061|
71652195|NCT01730040|142823040|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||=|0.0002|TWO_SIDED|99.0|-41.9|-7.8||Threshold for significance≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.8|-41.9|= 0.0002
71652196|NCT01730040|142823040|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.8|||<|0.0001|TWO_SIDED|99.0|-69.2|-36.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-36.5|-69.2|< 0.0001
71825307|NCT03441984|143154821|OTHER||Ratio of geometric LS means|0.9994|||||TWO_SIDED|90.0|0.9525|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0486|0.9525|
71652197|NCT01730040|142823040|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|||<|0.0001|TWO_SIDED|99.0|-51.3|-18.6|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-51.3|< 0.0001
71652198|NCT01730040|142823040|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.4|||<|0.0001|TWO_SIDED|99.0|-50.0|-16.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.8|-50.0|< 0.0001
71652199|NCT01730040|142823041|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|99.0|-54.0|-25.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.6|-54|<0.0001
71703934|NCT03277274|142925410|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.201|||||||ANOVA|||||||0.201
71703935|NCT03277274|142925410|OTHER|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA|||||||0.023
71825308|NCT03441984|143154821|OTHER||Ratio of geometric LS means|0.9432|||||TWO_SIDED|90.0|0.899|0.9896|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9896|0.8990|
71825309|NCT03441984|143154821|OTHER||Ratio of geometric LS means|1.0596|||||TWO_SIDED|90.0|1.0099|1.1117|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1117|1.0099|
71825310|NCT03441984|143154822|OTHER||Ratio of geometric LS means|0.9362|||||TWO_SIDED|90.0|0.8677|1.0101|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.0101|0.8677|
71825311|NCT03441984|143154822|OTHER||Ratio of geometric LS means|0.9079|||||TWO_SIDED|90.0|0.8416|0.9795|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||0.9795|0.8416|
71825312|NCT03441984|143154822|OTHER||Ratio of geometric LS means|1.0312|||||TWO_SIDED|90.0|0.9558|1.1124|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.1124|0.9558|
71825313|NCT03441984|143154823|OTHER||Ratio of geometric LS means|1.6439|||||TWO_SIDED|90.0|1.4649|1.8449|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8449|1.4649|
71825314|NCT03441984|143154823|OTHER||Ratio of geometric LS means|1.2698|||||TWO_SIDED|90.0|1.1315|1.425|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4250|1.1315|
71825315|NCT03441984|143154823|OTHER||Ratio of geometric LS means|1.2946|||||TWO_SIDED|90.0|1.1536|1.4529|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4529|1.1536|
71825316|NCT03441984|143154824|OTHER||Ratio of geometric LS means|1.6578|||||TWO_SIDED|90.0|1.4709|1.8685|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.8685|1.4709|
71825317|NCT03441984|143154824|OTHER||Ratio of geometric LS means|1.2755|||||TWO_SIDED|90.0|1.1317|1.4375|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4375|1.1317|
71825318|NCT03441984|143154824|OTHER||Ratio of geometric LS means|1.2998|||||TWO_SIDED|90.0|1.1533|1.465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4650|1.1533|
71825319|NCT03441984|143154825|OTHER||Ratio of geometric LS means|1.9758|||||TWO_SIDED|90.0|1.7585|2.2201|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||2.2201|1.7585|
71652200|NCT01730040|142823041|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|99.0|-40.0|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.0|<0.0001
71703936|NCT03921541|142925416|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71703937|NCT03921541|142925417|SUPERIORITY|||||||0.5961|||||||Mixed Models Analysis|||||||0.5961
71652201|NCT01730040|142823041|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.0|||<|0.0001|TWO_SIDED|99.0|-47.7|-24.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.3|-47.7|<0.0001
71825320|NCT03441984|143154825|OTHER||Ratio of geometric LS means|1.2873|||||TWO_SIDED|90.0|1.1457|1.4465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4465|1.1457|
71825321|NCT03441984|143154825|OTHER||Ratio of geometric LS means|1.5348|||||TWO_SIDED|90.0|1.366|1.7245|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.7245|1.3660|
71825322|NCT03441984|143154826|OTHER||Ratio of geometric LS means|0.9798|||||TWO_SIDED|90.0|0.9241|1.0389|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0389|0.9241|
71825323|NCT03441984|143154826|OTHER||Ratio of geometric LS means|0.9605|||||TWO_SIDED|90.0|0.9059|1.0185|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0185|0.9059|
71825324|NCT03441984|143154826|OTHER||Ratio of geometric LS means|1.0201|||||TWO_SIDED|90.0|0.9633|1.0802|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0802|0.9633|
71825325|NCT03441984|143154827|OTHER||Ratio of geometric LS means|0.9831|||||TWO_SIDED|90.0|0.9243|1.0457|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0457|0.9243|
71763020|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.85
71763021|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.13||||||P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.13
71825326|NCT03441984|143154827|OTHER||Ratio of geometric LS means|0.9702|||||TWO_SIDED|90.0|0.9121|1.032|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0320|0.9121|
71703938|NCT03921541|142925418|SUPERIORITY|||||||0.1087|||||||Mixed Models Analysis|||||||0.1087
71825327|NCT03441984|143154827|OTHER||Ratio of geometric LS means|1.0134|||||TWO_SIDED|90.0|0.9527|1.0779|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0779|0.9527|
71703939|NCT03921541|142925419|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71703940|NCT03921541|142925420|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71703941|NCT03921541|142925421|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71703942|NCT03921541|142925423|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71703943|NCT03921541|142925424|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71703944|NCT03921541|142925425|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71763022|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.03
71825328|NCT03441984|143154828|OTHER||Ratio of geometric LS means|0.91|||||TWO_SIDED|90.0|0.8196|1.0102|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.|||1.0102|0.8196|
71825329|NCT03441984|143154828|OTHER||Ratio of geometric LS means|0.9198|||||TWO_SIDED|90.0|0.8285|1.0212|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.0212|0.8285|
71825330|NCT03441984|143154828|OTHER||Ratio of geometric LS means|0.9893|||||TWO_SIDED|90.0|0.8911|1.0983|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0983|0.8911|
71825331|NCT03441984|143154834|OTHER||Ratio of geometric LS means|1.6503|||||TWO_SIDED|90.0|1.5131|1.8|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.8000|1.5131|
71825332|NCT03441984|143154834|OTHER||Ratio of geometric LS means|1.3501|||||TWO_SIDED|90.0|1.2381|1.4722|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.|||1.4722|1.2381|
71825333|NCT03441984|143154834|OTHER||Ratio of geometric LS means|1.2224|||||TWO_SIDED|90.0|1.121|1.333|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.3330|1.1210|
71825334|NCT03441984|143154843|OTHER||Ratio of geometric LS means|1.0251|||||TWO_SIDED|90.0|0.848|1.2392|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2392|0.8480|
71825335|NCT03441984|143154843|OTHER||Ratio of geometric LS means|0.9181|||||TWO_SIDED|90.0|0.7592|1.1103|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1103|0.7592|
71825336|NCT03441984|143154843|OTHER||Ratio of geometric LS means|1.1165|||||TWO_SIDED|90.0|0.9376|1.3295|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented|||1.3295|0.9376|
71825337|NCT03441984|143154851|OTHER||Ratio of geometric LS means|1.0844|||||TWO_SIDED|90.0|0.9904|1.1873|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.1873|0.9904|
71825338|NCT03441984|143154851|OTHER||Ratio of geometric LS means|1.1311|||||TWO_SIDED|90.0|1.0334|1.2379|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented|||1.2379|1.0334|
71825339|NCT03441984|143154851|OTHER||Ratio of geometric LS means|0.9587|||||TWO_SIDED|90.0|0.876|1.0493|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.|||1.0493|0.8760|
71825340|NCT03441984|143154859|OTHER||Ratio of geometric LS means|1.5619|||||TWO_SIDED|90.0|1.3678|1.7835|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.7835|1.3678|
71825341|NCT03441984|143154859|OTHER||Ratio of geometric LS means|1.253|||||TWO_SIDED|90.0|1.0973|1.4307|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.4307|1.0973|
71825342|NCT03441984|143154859|OTHER||Ratio of geometric LS means|1.2466|||||TWO_SIDED|90.0|1.0917|1.4234|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.4234|1.0917|
71652202|NCT01730040|142823041|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-39.2|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.4|-39.2|<0.0001
71652203|NCT01730040|142823041|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.9|||<|0.0001|TWO_SIDED|99.0|-32.8|-8.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.9|-32.8|<0.0001
71703945|NCT03921541|142925426|SUPERIORITY|||||||0.0208|||||||Mixed Models Analysis|||||||0.0208
71825343|NCT03441984|143154868|OTHER||Ratio of geometric LS means|1.0745|||||TWO_SIDED|90.0|0.9997|1.1549|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented|||1.1549|0.9997|
71825344|NCT03441984|143154868|OTHER||Ratio of geometric LS means|1.0706|||||TWO_SIDED|90.0|0.9961|1.1507|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.|||1.1507|0.9961|
71825345|NCT03441984|143154868|OTHER||Ratio of geometric LS means|1.0036|||||TWO_SIDED|90.0|0.9338|1.0787|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.|||1.0787|0.9338|
71652204|NCT01730040|142823042|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.5|||<|0.0001|TWO_SIDED|99.0|-55.8|-33.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-33.1|-55.8|<0.0001
71652205|NCT01730040|142823042|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-38.0|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-38.0|<0.0001
71652206|NCT01730040|142823042|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.3|||<|0.0001|TWO_SIDED|99.0|-48.1|-24.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-24.5|-48.1|<0.0001
71652207|NCT01730040|142823042|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.0001|TWO_SIDED|99.0|-39.6|-15.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.8|-39.6|<0.0001
71825346|NCT00580801|143154955|SUPERIORITY_OR_OTHER||Least square mean ratio|0.98||||||90.0|0.54|1.78|||||Day 1: The least square (LS) means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.78|0.54|
71825347|NCT00580801|143154955|SUPERIORITY_OR_OTHER||Least square mean ratio|1.33||||||90.0|1.03|1.72|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|1.03|
71825348|NCT00580801|143154956|SUPERIORITY_OR_OTHER||Least square mean ratio|1.0||||||90.0|0.58|1.72|||||Day 1: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.72|0.58|
71825349|NCT00580801|143154956|SUPERIORITY_OR_OTHER||Least square mean ratio|1.32||||||90.0|1.05|1.66|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.66|1.05|
71825350|NCT00580801|143154957|SUPERIORITY_OR_OTHER||Least square mean ratio|1.43||||||90.0|1.02|2.02|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||2.02|1.02|
71825351|NCT00580801|143154958|SUPERIORITY_OR_OTHER||Least square mean ratio|1.24||||||90.0|0.88|1.74|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.|||1.74|0.88|
71825352|NCT01664104|143155062|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
71763023|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.71||||||P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.71
71703946|NCT03921541|142925427|SUPERIORITY|||||||0.4434|||||||Mixed Models Analysis|||||||0.4434
71703947|NCT03921541|142925428|SUPERIORITY|||||||0.5301|||||||Mixed Models Analysis|||||||0.5301
71703948|NCT03921541|142925429|SUPERIORITY|||||||0.2515|||||||Mixed Models Analysis|||||||0.2515
71703949|NCT01778985|142925467|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71703950|NCT01778985|142925468|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71703951|NCT01778985|142925469|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71703952|NCT01778985|142925470|SUPERIORITY_OR_OTHER|||||||0.088|||||||t-test, 2 sided|t(18)=1.78, p=0.088||||||0.088
71763024|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.34
71825353|NCT01664104|143155062|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
71825354|NCT01664104|143155063|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
71825355|NCT01664104|143155063|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
71825356|NCT01664104|143155064|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 3.||||||<0.0001
71825357|NCT01664104|143155064|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.||||||<0.0001
71825358|NCT01664104|143155084|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
71825359|NCT01664104|143155084|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
71825360|NCT01664104|143155085|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test|||||||<0.0001
71825361|NCT01664104|143155085|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test|||||||<0.0001
71703953|NCT01778985|142925471|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71703954|NCT01778985|142925472|SUPERIORITY_OR_OTHER|||||||0.91||||||t(28)=0.11, p=0.91|t-test, 2 sided|||||||0.91
71703955|NCT01778985|142925473|SUPERIORITY_OR_OTHER|||||||0.1||||||t(18)=1.69, p=.10|t-test, 2 sided|||||||0.10
71703956|NCT01778985|142925474|SUPERIORITY_OR_OTHER|||||||0.02||||||t(10)=2.76, p=0.020|t-test, 2 sided|||||||0.020
71703957|NCT01778985|142925475|SUPERIORITY_OR_OTHER|||||||0.78||||||t(23)=0.28, p=0.78|t-test, 2 sided|||||||0.78
71703958|NCT01778985|142925476|SUPERIORITY_OR_OTHER|||||||0.51||||||t(28)=0.67, p=0.51|t-test, 2 sided|||||||0.51
71703959|NCT01778985|142925477|SUPERIORITY_OR_OTHER|||||||0.24||||||t(23)=1.23, p=0.24|t-test, 2 sided|||||||0.24
71703960|NCT01778985|142925478|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
71703961|NCT01778985|142925479|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71703962|NCT01778985|142925480|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71703963|NCT01778985|142925481|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
71703964|NCT01778985|142925482|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
71703965|NCT01778985|142925483|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
71703966|NCT01778985|142925484|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71703967|NCT01778985|142925485|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71703968|NCT01778985|142925486|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1
71763025|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.41
71763026|NCT01057589|143027418|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.37
71763027|NCT01253577|143027427|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||McNemar|||||||0.0280
71763028|NCT01253577|143027428|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Fisher Exact|||||||<0.0001
71825362|NCT01664104|143155086|SUPERIORITY_OR_OTHER|||||||0.6904|||||||t-test|P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.6904
71825363|NCT01664104|143155086|SUPERIORITY_OR_OTHER|||||||0.6032|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.6032
71703969|NCT00835978|142925498|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.578||||0.0189|TWO_SIDED|95.0|1.017|2.448||A priori defined threshold for statistical significance was: alpha=0.10 (one-sided)|Cochran-Mantel-Haenszel|||ORR for the 2 treatment arms was compared with the Cochran-Mantel-Haenszel test stratified by ECOG performance status. The relative risk ratio estimator was used to contrast the treatment effects on the endpoint. Both a point estimate and a 2-sided 95% CI were calculated using a normal approximation.||2.448|1.017|0.0189
71703970|NCT00835978|142925499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.849||||0.2444|TWO_SIDED|95.0|0.535|1.348|||Log Rank|||||1.348|0.535|0.2444
71703971|NCT00327171|142925531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.5043|TWO_SIDED|95.0|0.8|1.58|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor|||1.58|0.80|0.5043
71703972|NCT00327171|142925534|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.5592|TWO_SIDED|95.0|0.81|1.48|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4mg/kg vs. 2mg/kg)|||1.48|0.81|0.5592
71703973|NCT00327171|142925535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.124||||0.5457|TWO_SIDED|95.0|0.77|1.64|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4 mg/kg vs. 2mg/kg)|||1.64|0.77|0.5457
71703974|NCT00758043|142925592|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|4.5|||||TWO_SIDED|95.0|-2.1|11.1||||||Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.||11.1|-2.1|
71703975|NCT00758043|142925592|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.2||||||SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.||8.2|-4.3|
71703976|NCT00758043|142925593|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Difference in Proportion|-0.5|||||TWO_SIDED|95.0|-7.7|6.8||||||||6.8|-7.7|
71825364|NCT01664104|143155086|SUPERIORITY_OR_OTHER|||||||0.6146|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.6146
71825365|NCT01664104|143155087|SUPERIORITY_OR_OTHER|||||||0.0018|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).||||||0.0018
71703977|NCT00758043|142925593|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.49|1.82||||||||1.82|0.49|
71703978|NCT00845182|142925622|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
71703979|NCT00845182|142925622|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71703980|NCT01286324|142925640|SUPERIORITY|||||||0.21||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.21
71703981|NCT01286324|142925641|SUPERIORITY|||||||0.6||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.60
71825366|NCT01664104|143155087|SUPERIORITY_OR_OTHER|||||||0.1617|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).||||||0.1617
71825367|NCT01664104|143155087|SUPERIORITY_OR_OTHER|||||||0.1296|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).||||||0.1296
71825368|NCT01664104|143155090|SUPERIORITY_OR_OTHER|||||||0.5332|||||||t-test|P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.5332
71703982|NCT01286324|142925642|SUPERIORITY|||||||0.47||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||Statistical Analysis for State Subscale||||0.47
71703983|NCT01286324|142925642|SUPERIORITY|||||||0.45||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||P-value for Trait Subscale||||0.45
71763029|NCT01253577|143027429|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|95.0|||||McNemar|||||||0.0023
71825369|NCT01664104|143155091|SUPERIORITY_OR_OTHER|||||||0.6159|||||||t-test|P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus \> 30 minutes).||||||0.6159
71825370|NCT01664104|143155092|SUPERIORITY_OR_OTHER|||||||0.237|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.2370
71825371|NCT01664104|143155092|SUPERIORITY_OR_OTHER|||||||0.8033|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.||||||0.8033
71825372|NCT01664104|143155093|SUPERIORITY_OR_OTHER|||||||0.0306|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0306
71825373|NCT01664104|143155093|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.||||||0.0749
71825374|NCT01664104|143155094|SUPERIORITY_OR_OTHER|||||||0.4854|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.4854
71825375|NCT01664104|143155094|SUPERIORITY_OR_OTHER|||||||0.325|||||||S|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.3250
71825376|NCT01664104|143155095|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0011
71825377|NCT01664104|143155095|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Spearman Correlation|P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.||||||0.0013
71652208|NCT01730040|142823042|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.2|||<|0.0001|TWO_SIDED|99.0|-32.2|-8.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-32.2|<0.0001
71652209|NCT01730040|142823043|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-42.0|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.6|-42.0|<0.0001
71652210|NCT01730040|142823043|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|99.0|-36.6|-10.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-10.7|-36.6|<0.0001
71652211|NCT01730040|142823043|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|99.0|-50.8|-26.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-26.0|-50.8|<0.0001
71652212|NCT01730040|142823043|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.9|||<|0.0001|TWO_SIDED|99.0|-43.2|-18.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.6|-43.2|<0.0001
71652213|NCT01730040|142823043|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|99.0|-40.1|-15.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.1|-40.1|<0.0001
71652214|NCT01730040|142823044|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.6|||<|0.0001|TWO_SIDED|99.0|-44.6|-20.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.6|-44.6|<0.0001
71652215|NCT01730040|142823044|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|99.0|-37.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-37.3|<0.0001
71652216|NCT01730040|142823044|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.3|||<|0.0001|TWO_SIDED|99.0|-51.2|-25.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-25.4|-51.2|<0.0001
71652217|NCT01730040|142823044|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|99.0|-42.6|-17.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.1|-42.6|<0.0001
71652218|NCT01730040|142823044|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|99.0|-39.4|-13.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.4|-39.4|<0.0001
71886504|NCT02066792|143293393|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.635|TWO_SIDED|95.0|-0.37|0.23||Two-sided|Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||.23|-.37|.635
71652219|NCT01730040|142823045|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|99.0|-44.7|-16.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-16.1|-44.7|<0.0001
71652220|NCT01730040|142823045|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.6|||=|0.0002|TWO_SIDED|99.0|-36.1|-7.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.1|-36.1|=0.0002
71652221|NCT01730040|142823045|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.1|||<|0.0001|TWO_SIDED|99.0|-54.7|-27.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-27.5|-54.7|<0.0001
71652222|NCT01730040|142823045|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2|||<|0.0001|TWO_SIDED|99.0|-43.7|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.6|-43.7|<0.0001
71652223|NCT01730040|142823045|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.6|||<|0.0001|TWO_SIDED|99.0|-40.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.8|-40.3|<0.0001
71652224|NCT01730040|142823046|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.0|||<|0.0001|TWO_SIDED|99.0|-47.0|-19.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-19.0|-47.0|<0.0001
71652225|NCT01730040|142823046|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|99.0|-36.6|-8.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.1|-36.6|<0.0001
71652226|NCT01730040|142823046|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|99.0|-57.4|-29.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-29.7|-57.4|<0.0001
71825378|NCT01664104|143155096|SUPERIORITY_OR_OTHER|||||||0.5655|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.5655
71825379|NCT01664104|143155096|SUPERIORITY_OR_OTHER|||||||0.3977|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.||||||0.3977
71825380|NCT01664104|143155097|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Pearson correlation|P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.||||||0.0123
71825381|NCT01664104|143155097|SUPERIORITY_OR_OTHER|||||||0.0151|||||||Spearman Correlation|P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6||||||0.0151
71825382|NCT01664104|143155098|SUPERIORITY_OR_OTHER|||||||0.9909|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.9909
71652227|NCT01730040|142823046|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.1|||<|0.0001|TWO_SIDED|99.0|-46.0|-18.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.3|-46.0|<0.0001
71652228|NCT01730040|142823046|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|99.0|-41.4|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-13.2|-41.4|<0.0001
71652229|NCT01730040|142823047|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|99.0|-32.9|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.2|-32.9|<0.0001
71703984|NCT01286324|142925643|SUPERIORITY|||||||0.11||||||P value is adjusted based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||||||0.11
71703985|NCT05558410|142925655|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71703986|NCT05558410|142925656|SUPERIORITY|||||||0.2781|||||||ANCOVA|||||||0.2781
71703987|NCT05558410|142925657|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71703988|NCT05558410|142925658|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71703989|NCT05558410|142925659|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71703990|NCT05558410|142925660|SUPERIORITY||||||<|0.0001|||||||Pearson's chi-squared test|||||||<0.0001
71703991|NCT05558410|142925661|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71703992|NCT05558410|142925662|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71703993|NCT05558410|142925663|SUPERIORITY|||||||0.0237|||||||Cochran-Mantel-Haenszel|||||||0.0237
71703994|NCT05558410|142925664|SUPERIORITY|||||||0.008|||||||Wilcoxon rank-sum|||||||0.0080
71825383|NCT01664104|143155098|SUPERIORITY_OR_OTHER|||||||0.6482|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.||||||0.6482
71825384|NCT03582956|143155113|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
71825385|NCT03582956|143155114|SUPERIORITY|||||||0.607|||||||t-test, 2 sided|||||||0.607
71825386|NCT03582956|143155115|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||0.466
71825387|NCT03582956|143155116|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
71652230|NCT01730040|142823047|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-25.8|-5.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-5.8|-25.8|<0.0001
71652231|NCT01730040|142823047|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.9|||<|0.0001|TWO_SIDED|99.0|-39.4|-18.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.4|-39.4|<0.0001
71652232|NCT01730040|142823047|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.9|||<|0.0001|TWO_SIDED|99.0|-32.4|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-32.4|<0.0001
71652233|NCT01730040|142823047|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.4|||<|0.0001|TWO_SIDED|99.0|-29.1|-7.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-29.1|<0.0001
71703995|NCT02400580|142925669|OTHER|||||||0.517|||||||Fisher Exact|||||||0.517
71703996|NCT02400580|142925671|OTHER|||||||0.508|||||||Fisher Exact|||||||0.508
71703997|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71703998|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paited t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71703999|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704000|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704001|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704002|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704003|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71825388|NCT00517933|143155164|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
71825389|NCT00517933|143155166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.11|TWO_SIDED|95.0|-3.9|37.3|||Regression, Linear|||||37.3|-3.9|0.11
71825390|NCT00517933|143155167|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Log Rank|||||||0.41
71825391|NCT00517933|143155168|SUPERIORITY_OR_OTHER||Slope|-6.58|STANDARD_ERROR_OF_MEAN|2.3||0.006|TWO_SIDED|95.0|-11.25|-1.92|||Mixed Models Analysis|||||-1.92|-11.25|0.006
71825392|NCT00517933|143155170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7|TWO_SIDED|95.0|-0.05|0.07|||Mixed Models Analysis|||||0.07|-0.05|0.70
71652234|NCT01730040|142823048|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|99.0|-41.6|-21.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.3|-41.6|<0.0001
71652235|NCT01730040|142823048|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|99.0|-35.4|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.2|-35.4|<0.0001
71652236|NCT01730040|142823048|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|||<|0.0001|TWO_SIDED|99.0|-35.9|-17.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-35.9|<0.0001
71652237|NCT01730040|142823048|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.2|||<|0.0001|TWO_SIDED|99.0|-31.5|-12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.9|-31.5|<0.0001
71652238|NCT01730040|142823048|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.9|||<|0.0001|TWO_SIDED|99.0|-25.2|-6.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-6.6|-25.2|<0.0001
71652239|NCT01730040|142823049|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.5|||<|0.0001|TWO_SIDED|99.0|-45.3|-21.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.6|-45.3|<0.0001
71652240|NCT01730040|142823049|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.4|||<|0.0001|TWO_SIDED|99.0|-35.2|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-35.2|<0.0001
71652241|NCT01730040|142823049|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|99.0|-39.0|-19.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.6|-39.0|<0.0001
71652242|NCT01730040|142823049|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|99.0|-32.3|-12.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.7|-32.3|<0.0001
71825393|NCT00517933|143155172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.04|TWO_SIDED|95.0|0.1|3.0|||Mixed Models Analysis|||||3.0|0.1|0.04
71825394|NCT00517933|143155174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.16|TWO_SIDED|95.0|-0.81|0.14|||Regression, Linear|||||0.14|-0.81|0.16
71825395|NCT00517933|143155176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.01|TWO_SIDED|95.0|-7.3|-0.9|||Regression, Linear|||||-0.9|-7.3|0.01
71825396|NCT00517933|143155178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.02|TWO_SIDED|95.0|-10.6|-0.9|||Regression, Linear|||||-0.9|-10.6|0.02
71825397|NCT00517933|143155180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.04|TWO_SIDED|95.0|-7.2|-0.1|||Regression, Linear|||||-0.1|-7.2|0.04
71825398|NCT00517933|143155182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.07|TWO_SIDED|95.0|-7.8|0.4|||Regression, Logistic|||||0.4|-7.8|0.07
71825399|NCT00517933|143155184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED|95.0|-0.01|0.06|||Regression, Linear|||||0.06|-0.01|0.18
71825400|NCT00517933|143155186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.37|TWO_SIDED|95.0|-2.8|7.3|||Regression, Linear|||||7.3|-2.8|0.37
71652243|NCT01730040|142823049|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.8|||<|0.0001|TWO_SIDED|99.0|-24.7|-4.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-4.9|-24.7|<0.0001
71652244|NCT01730040|142823050|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.6|||<|0.0001|TWO_SIDED|99.0|-31.4|-13.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-13.8|-31.4|<0.0001
71652245|NCT01730040|142823050|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|99.0|-24.6|-7.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.0|-24.6|<0.0001
71652246|NCT01730040|142823050|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.1|||<|0.0001|TWO_SIDED|99.0|-26.9|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.4|-26.9|<0.0001
71652247|NCT01730040|142823050|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|99.0|-23.3|-7.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.6|-23.3|<0.0001
71652248|NCT01730040|142823050|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8|||=|0.0015|TWO_SIDED|99.0|-17.7|-1.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-1.9|-17.7|=0.0015
71652249|NCT01730040|142823051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.7|||<|0.0001|TWO_SIDED|99.0|3.9|71.7||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.7|3.9|<0.0001
71652250|NCT01730040|142823051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||=|0.0284|TWO_SIDED|99.0|0.8|14.6||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||14.6|0.8|=0.0284
71652251|NCT01730040|142823051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|83.2|||<|0.0001|TWO_SIDED|99.0|11.6|596.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||596.8|11.6|<0.0001
71825401|NCT00517933|143155190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.008|TWO_SIDED|95.0|0.8|5.0|||Regression, Linear|||||5.0|0.8|0.008
71825402|NCT00517933|143155192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.86|TWO_SIDED|95.0|-2.1|1.7|||Regression, Linear|||||1.7|-2.1|0.86
71886505|NCT02066792|143293393|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.8|-0.18|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||||-.18|-.80|.002
71704004|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704005|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71704006|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704007|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704008|NCT01336972|142925677|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704009|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704010|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704011|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704012|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704013|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704014|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71763030|NCT00479687|143027623|SUPERIORITY|||||||0.038||||||There was a single primary variable and the a-prior threshold for statistical significance was 0.05.|Mixed Models Analysis|mixed effects repeated measure model with baseline VAS, treatment, and week as fixed effects and subject nested within site as a random effect.||||||0.0380
71763031|NCT01474239|143027632|SUPERIORITY_OR_OTHER|||||||0.4291|TWO_SIDED|||||Statistical significance was assessed with a one-sided alpha error of 10 percent (%).|Exact Binomial Test|||The 6-month OS rate (OS-6) for bevacizumab was compared to the expected proportion of 0.60 under null hypothesis (ineffective treatment) with the application of the exact binomial test. The one-tailed statistical hypotheses was p0 less than or equal to (≤) 0.60 (null hypothesis) versus pA greater than or equal to (≥) 0.77 (alternative hypothesis), where p is the estimated probability of survival at 6 months.||||0.4291
71763032|NCT00459732|143027654|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED|95.0|||||ANOVA|||||||0.13
71763033|NCT00459732|143027655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|TWO_SIDED|95.0|||||ANOVA|Repeated measures||||||0.44
71763034|NCT00459732|143027656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|95.0|||||ANCOVA|Repeated measures analysis of variance adjusted for baseline osteocalcin level.||||||0.16
71763035|NCT03983317|143027686|OTHER|We tested if the average drinks consumed was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.026|||||||t-test, 2 sided|Paired t-test||||||0.026
71763036|NCT03983317|143027688|OTHER|We tested if the average craving intensity was statistically different in Week 2 of the Treatment Phase vs. the Baseline Phase. This was evaluated via a paired t-test.||||||0.001|||||||t-test, 2 sided|Paired t-test||||||0.001
71763037|NCT02891070|143027762|NON_INFERIORITY|To demonstrate non-inferiority (NI) of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.|Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
71763038|NCT02891070|143027764|OTHER||Mean Difference (Net)|-9.29|||||TWO_SIDED|95.0|-21.11|2.54|||Regression, Logistic||Difference in Average Predicted Proportion (Tisseel - Duraseal)|||2.54|-21.11|
71763039|NCT02891070|143027765|OTHER|||||||0.0241|||||||Wilcoxon (Mann-Whitney)|||||||0.0241
71886506|NCT02066792|143293393|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.73|-0.14|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.14|-.73|.004
71652252|NCT01730040|142823051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2|||=|0.0025|TWO_SIDED|99.0|1.3|38.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||38.3|1.3|=0.0025
71652253|NCT01730040|142823051|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1|||=|0.0011|TWO_SIDED|99.0|1.6|52.2||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||52.2|1.6|=0.0011
71652254|NCT01730040|142823052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|128.4|||<|0.0001|TWO_SIDED|99.0|14.2|1157.0||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1157|14.2|<0.0001
71652255|NCT01730040|142823052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.9|||=|0.0015|TWO_SIDED|99.0|1.6|75.4||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||75.4|1.6|=0.0015
71652256|NCT01730040|142823052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.7|||=|0.0008|TWO_SIDED|99.0|1.8|101.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||101.1|1.8|=0.0008
71652257|NCT01730040|142823053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|116.8|||<|0.0001|TWO_SIDED|99.0|14.7|927.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||927.5|14.7|<0.0001
71652258|NCT01730040|142823053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.2|||<|0.0001|TWO_SIDED|99.0|2.5|68.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||68.8|2.5|<0.0001
71652259|NCT01730040|142823053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.9|||=|0.0004|TWO_SIDED|99.0|1.9|51.9||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||51.9|1.9|=0.0004
71652260|NCT01730040|142823054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|162.1|||<|0.0001|TWO_SIDED|99.0|17.3|1520.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1520.5|17.3|<0.0001
71652261|NCT01730040|142823054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.8|||<|0.0001|TWO_SIDED|99.0|3.1|126.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||126.3|3.1|<0.0001
71652262|NCT01730040|142823054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||=|0.0002|TWO_SIDED|99.0|2.2|88.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||88.1|2.2|=0.0002
71652263|NCT01730040|142823055|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.1|||=|0.0004|TWO_SIDED|99.0|-36.3|-5.9||Threshold for significance ≤ 0.01.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-5.9|-36.3|=0.0004
71652264|NCT01730040|142823055|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.9|||<|0.0001|TWO_SIDED|99.0|-40.2|-11.6||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.6|-40.2|<0.0001
71652265|NCT01730040|142823055|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.0|||<|0.0001|TWO_SIDED|99.0|-45.6|-16.4||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-45.6|<0.0001
71652266|NCT01730040|142823056|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||=|0.4456|TWO_SIDED|99.0|-7.0|12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).||12.9|-7.0|=0.4456
71652267|NCT02631837|142823063|NON_INFERIORITY|Our hypothesis was that women would accept a higher conversion rate of 15% for vNOTESbased on a telephone interview of 10 women treated by total vaginal NOTES hysterectomy. Women were asked to choose among ﬁve cut-off rates (5, 10, 15, 20 or 25%). Most women indicated 15%. We would conclude non-inferiority when the upper limit of the one-sided 95% conﬁdence interval for the difference in the proportions of women between both comparisons would be below 15%.||||||0.0221||||||The Farrington-Manning test for non-inferiority was performed with 5% significance level and yielded P = 0.0221 in a sensitivity analysis assuming one conversion in the vNOTES and 0 conversions in the laparoscopy group.|Farrington-Manning|||||||0.0221
71652268|NCT02631837|142823064|SUPERIORITY||Risk Difference (RD)|-0.34||||0.007|TWO_SIDED|95.0|-0.56|-0.13|||Fisher Exact|||||-0.13|-0.56|0.007
71652269|NCT02631837|142823064|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
71652270|NCT02631837|142823066|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.006|TWO_SIDED|95.0|-10.0|-1.8|||Mann-Whitney U test|Two-sided test||||-1.8|-10|0.006
71652271|NCT02631837|142823067|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71652272|NCT02631837|142823068|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||> 0.05
71652273|NCT02631837|142823069|SUPERIORITY||Risk Difference (RD)|-0.29||||0.009|TWO_SIDED|95.0|-0.47|-0.1|||Fisher Exact|||||-0.10|-0.47|0.009
71652274|NCT02631837|142823070|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
71652275|NCT02631837|142823071|SUPERIORITY||Median Difference (Final Values)|-34.0|||<|0.01|TWO_SIDED|95.0|-46.0|-22.0|||Mann-Whitney U test|||||-22|-46|< 0.01
71652276|NCT02631837|142823072|SUPERIORITY|||||||0.7604||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.7604
71763040|NCT02891070|143027766|OTHER|||||||0.1015|||||||Wilcoxon (Mann-Whitney)|||||||0.1015
71704015|NCT01336972|142925678|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71825403|NCT04888585|143155202|SUPERIORITY||Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|11.5|31.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||31.0|11.5|<0.001
71704016|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71825404|NCT04888585|143155202|SUPERIORITY||Response Rate Difference|26.6|||<|0.001|TWO_SIDED|95.0|16.5|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||36.7|16.5|<0.001
71704017|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704018|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704019|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding||||>0.05
71704020|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704021|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704022|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||<0.05
71704023|NCT01336972|142925679|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.||||>0.05
71704024|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
71704025|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71704026|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71704027|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
71704028|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Test to compare treatment groups at Final Treatment||||||>0.05
71704029|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|paired t-test|||||||>0.05
71886507|NCT02066792|143293393|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.16||0.008|TWO_SIDED|95.0|-0.72|-0.11|||Mixed Models Analysis|Four level multivariate MLM with measures nested within time, which was nested within subjects, who were nested within treatment cohort.||3 month follow-up||-.11|-.72|.008
71704030|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
71704031|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
71825405|NCT04888585|143155202|SUPERIORITY||Response Rate Difference|37.7|||<|0.001|TWO_SIDED|95.0|27.4|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||48.1|27.4|<0.001
71704032|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||>0.05
71704033|NCT01336972|142925680|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||||||<0.05
71704034|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Final Treatment||||<0.05
71704035|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Comparison of all treatment groups versus Baseline at Post Treatment||||<0.05
71704036|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71704037|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
71704038|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71704039|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704040|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704041|NCT01336972|142925684|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704042|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
71704043|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
71704044|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71704045|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||<0.05
71704046|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare PostTreatment versus Baseline for all treatment groups||||>0.05
71886508|NCT04669678|143293394|OTHER||Odds Ratio (OR)|0.85||||0.306|TWO_SIDED|90.0|0.65|1.11|||Mixed Models Analysis|||Week 2||1.11|0.65|0.306
71886509|NCT04669678|143293394|OTHER||Odds Ratio (OR)|0.81||||0.874|TWO_SIDED|90.0|0.6|1.09|||Mixed Models Analysis|||Week 4||1.09|0.60|0.874
71704047|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704048|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704049|NCT01336972|142925685|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||<0.05
71704050|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired te-test|||Test to compare Final Treatment versus Baseline for all treatment groups||||<0.05
71704051|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71704052|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71704053|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment||||>0.05
71704054|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||<0.05
71763041|NCT02891070|143027767|OTHER|||||||0.9943|||||||Wilcoxon (Mann-Whitney)|||||||0.9943
71763042|NCT02891070|143027768|OTHER||Mean Difference (Net)|-5.11|||||TWO_SIDED|95.0|-13.6|3.39|||Regression, Logistic|||||3.39|-13.60|
71774894|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|1.07|STANDARD_ERROR_OF_MEAN|2.02||0.5952|TWO_SIDED|95.0|-2.89|5.03|||ANCOVA|||Baseline somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||5.03|-2.89|0.5952
71774895|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.72|STANDARD_ERROR_OF_MEAN|1.87||0.6984|TWO_SIDED|95.0|-4.4|2.95|||ANCOVA|||Week 16 somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||2.95|-4.40|0.6984
71886510|NCT04669678|143293394|OTHER||Odds Ratio (OR)|1.04||||0.646|TWO_SIDED|90.0|0.91|1.19|||Mixed Models Analysis|||Week 8||1.19|0.91|0.646
71704055|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71704056|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Paired t-test|||Test to compare Post Treatment versus Baseline||||>0.05
71704057|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704058|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704059|NCT01336972|142925686|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment||||>0.05
71704060|NCT02030418|142925732|SUPERIORITY|"The primary safety hypothesis is:~H0: CFR ≤ 86% vs. H1: CFR \> 86% Where CFR is the Complication Free Rate. The CFR is estimated as a binomial proportion and the 95% confidence interval (CI) of CFR is calculated using the Clopper-Pearson exact method. The null hypothesis is rejected at the 2.5% significance level if the lower bound of this CI exceeds the Performance Goal (PG) of 86%."|binomial proportion|93.3|||<|0.001|TWO_SIDED|95.0|89.9|95.9|||1-sided exact test for binomial proporti|||||95.9|89.9|<0.001
71704061|NCT02030418|142925733|SUPERIORITY|"The primary effectiveness hypothesis is:~H0: Rate ≤ 85.0% vs. H1: Rate \> 85.0%~where Rate is the proportion of subjects experiencing success, and success is defined as: pacing threshold voltage ≤ 2.0 V at 0.4 ms at 6-month visit and sensed R-wave amplitude either ≥ 5.0 mV at the 6-month visit or ≥ value at implant."|binomial proportion|93.4|||<|0.001|TWO_SIDED|95.0|89.9|96.0||The null hypothesis is rejected at the 2.5% significance level if the lower bound of the CI exceeds the Performance Goal (PG) of 85%.|1-sided exact test for binomial proporti|||||96.0|89.9|<0.001
71704062|NCT02030418|142925734|OTHER|"The hypothesis is intended to test whether the mean slope is within 35% of 1. The hypothesis is stated as follows:~H0: absolute value (Mean Slope - 100%) ≥ equivalence margin, equal to 35%~H1: absolute value (Mean Slope - 100%) \< equivalence margin, equal to 35%~The calculation of slope for individual subjects in the CAEP exercise protocol is done by setting the y-intercept to zero."|Slope|0.83|STANDARD_DEVIATION|0.27||0.001|TWO_SIDED|95.0|0.73|0.93|||two 1-sided test (TOST)|||||0.93|0.73|0.001
71704063|NCT03296345|142925739|OTHER||Mean Difference (Final Values)|-15.0||||0.004|TWO_SIDED|95.0|-28.0|-2.3|||Wilcoxon (Mann-Whitney)|||||-2.3|-28|0.004
71704064|NCT03296345|142925740|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71886511|NCT04669678|143293394|OTHER||Odds Ratio (OR)|1.02||||0.869|TWO_SIDED|90.0|0.82|1.28|||Mixed Models Analysis|||Week 12||1.28|0.82|0.869
71886512|NCT04669678|143293394|OTHER||Odds Ratio (OR)|0.51||||0.044|TWO_SIDED|90.0|0.3|0.88|||Mixed Models Analysis|||Week 2||0.88|0.30|0.044
71825406|NCT04888585|143155202|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|13.8|32.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||32.6|13.8|<0.001
71886513|NCT04669678|143293394|OTHER||Odds Ratio (OR)|0.36|||<|0.001|TWO_SIDED|90.0|0.28|0.46|||Mixed Models Analysis|||Week 4||0.46|0.28|<0.001
71886514|NCT04669678|143293394|OTHER||Odds Ratio (OR)|0.37|||<|0.001|TWO_SIDED|90.0|0.27|0.49|||Mixed Models Analysis|||Week 8||0.49|0.27|<0.001
71886515|NCT04669678|143293394|OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|90.0|0.35|0.54|||Mixed Models Analysis|||Week 12||0.54|0.35|<0.001
71886516|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.25||||0.641|TWO_SIDED|90.0|0.57|2.74|||Mixed Models Analysis|||Week 2||2.74|0.57|0.641
71886517|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.57||||0.204|TWO_SIDED|90.0|0.87|2.8|||Mixed Models Analysis|||Week 4||2.80|0.87|0.204
71886518|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.29||||0.415|TWO_SIDED|90.0|0.77|2.15|||Mixed Models Analysis|||Week 8||2.15|0.77|0.415
71886519|NCT04669678|143293395|OTHER||Odds Ratio (OR)|2.23||||0.027|TWO_SIDED|90.0|1.23|4.06|||Mixed Models Analysis|||Week 12||4.06|1.23|0.027
71652277|NCT02631837|142823073|SUPERIORITY|||||||0.3071||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3071
71652278|NCT02631837|142823074|SUPERIORITY|||||||0.4541||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4541
71652279|NCT02631837|142823075|SUPERIORITY|||||||0.4514||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.4514
71652280|NCT02631837|142823076|SUPERIORITY|||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
71652281|NCT02631837|142823077|SUPERIORITY|We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.||||||0.3473||||||We tested a treatment arm by time interaction to study changes in differences for the outcomes during the follow-up period. In absence of such an interaction (p\>0.05 for the interaction term), the main effect of treatment was tested.|Arm by time interaction|||||||0.3473
71652282|NCT02631837|142823079|SUPERIORITY||Mean Difference (Final Values)|-555.8||||0.11|TWO_SIDED|95.0||36.0|||Mann-Whitney U test|||||36|-1,044|0.110
71652283|NCT03346070|142823080|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.0075|TWO_SIDED|95.0|1.18|3.1|||Log Rank||Cox regression model|||3.10|1.18|0.0075
71652284|NCT03346070|142823080|SUPERIORITY||Hazard Ratio (HR)|25.9|||<|0.0001|TWO_SIDED|95.0|9.72|69.03|||Log Rank||Cox regression model|||69.03|9.72|<0.0001
71652285|NCT03346070|142823080|SUPERIORITY||Hazard Ratio (HR)|61.4|||<|0.0001|TWO_SIDED|95.0|14.13|266.77|||Log Rank||Cox regression model|||266.77|14.13|<0.0001
71652286|NCT03346070|142823080|SUPERIORITY||Hazard Ratio (HR)|2.38||||0.0005|TWO_SIDED|95.0|1.44|3.93|||Log Rank||Cox regression model|||3.93|1.44|0.0005
71652287|NCT03346070|142823080|SUPERIORITY||Hazard Ratio (HR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.5|3.01|||Log Rank||Cox regression model|||3.01|1.50|<0.0001
71652288|NCT03346070|142823081|SUPERIORITY||Difference in percentage|2.3||||0.602|TWO_SIDED|95.0|-9.6|15.0|||Miettinen & Nurminen method|||||15.0|-9.6|0.602
71652289|NCT03346070|142823081|SUPERIORITY||Difference in percentage|0.2||||0.969|TWO_SIDED|95.0|-13.4|13.5|||Miettinen & Nurminen method|||||13.5|-13.4|0.969
71652290|NCT03346070|142823081|SUPERIORITY||Difference in percentage|2.6||||0.567|TWO_SIDED|95.0|-8.7|15.0|||Miettinen & Nurminen method|||||15.0|-8.7|0.567
71652291|NCT03346070|142823081|SUPERIORITY||Difference in percentage|2.6||||0.571|TWO_SIDED|95.0|-8.8|15.0|||Miettinen & Nurminen method|||||15.0|-8.8|0.571
71652292|NCT03346070|142823081|SUPERIORITY||Difference in percentage|-0.2||||0.95|TWO_SIDED|95.0|-11.6|10.9|||Miettinen & Nurminen method|||||10.9|-11.6|0.950
71652293|NCT03346070|142823081|SUPERIORITY||Difference in percentage|2.9||||0.528|TWO_SIDED|95.0|-8.4|15.9|||Miettinen & Nurminen method|||||15.9|-8.4|0.528
71652294|NCT03346070|142823081|SUPERIORITY||Difference in percentage|1.3||||0.709|TWO_SIDED|95.0|-6.8|9.6|||Miettinen & Nurminen method|||||9.6|-6.8|0.709
71652295|NCT03346070|142823082|SUPERIORITY||Difference in percentage|2.2||||0.738|TWO_SIDED|95.0|-12.3|17.4|||Miettinen & Nurminen method|||||17.4|-12.3|0.738
71652296|NCT03346070|142823082|SUPERIORITY||Difference in percentage|11.1||||0.077|TWO_SIDED|95.0|-1.7|26.3|||Miettinen & Nurminen method|||||26.3|-1.7|0.077
71652297|NCT03346070|142823082|SUPERIORITY||Difference in percentage|2.4||||0.717|TWO_SIDED|95.0|-12.0|16.4|||Miettinen & Nurminen method|||||16.4|-12.0|0.717
71652298|NCT03346070|142823082|SUPERIORITY||Difference in percentage|5.0||||0.486|TWO_SIDED|95.0|-9.9|19.7|||Miettinen & Nurminen method|||||19.7|-9.9|0.486
71652299|NCT03346070|142823082|SUPERIORITY||Difference in percentage|-1.2||||0.849|TWO_SIDED|95.0|-16.2|12.4|||Miettinen & Nurminen method|||||12.4|-16.2|0.849
71652300|NCT03346070|142823082|SUPERIORITY||Difference in percentage|-4.9||||0.339|TWO_SIDED|95.0|-18.2|6.7|||Miettinen & Nurminen method|||||6.7|-18.2|0.339
71652301|NCT03346070|142823082|SUPERIORITY||Difference in percentage|6.6||||0.149|TWO_SIDED|95.0|-2.6|16.8|||Miettinen & Nurminen method|||||16.8|-2.6|0.149
71652302|NCT03346070|142823083|SUPERIORITY||Difference in percentage|-2.7||||0.299|TWO_SIDED|95.0|-13.9|6.7|||Miettinen & Nurminen method|||||6.7|-13.9|0.299
71652303|NCT03346070|142823083|SUPERIORITY||Difference in percentage|0.0|||>|0.999|TWO_SIDED|95.0|-9.9|9.4|||Miettinen & Nurminen method|||||9.4|-9.9|>0.999
71652304|NCT03346070|142823083|SUPERIORITY||Difference in percentage|-2.6||||0.326|TWO_SIDED|95.0|-13.7|7.0|||Miettinen & Nurminen method|||||7.0|-13.7|0.326
71652305|NCT03346070|142823083|SUPERIORITY||Difference in percentage|-2.5||||0.335|TWO_SIDED|95.0|-13.6|7.1|||Miettinen & Nurminen method|||||7.1|-13.6|0.335
71825407|NCT04888585|143155203|SUPERIORITY||Least Squares (LS) Mean Difference|-0.51||||0.007|TWO_SIDED|95.0|-0.87|-0.14|||Mixed Models Analysis|MMRM includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg - Placebo|||-0.14|-0.87|0.007
71825408|NCT04888585|143155203|SUPERIORITY||Least Squares (LS) Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.64|-1.38|<0.001
71825409|NCT04888585|143155203|SUPERIORITY||Least Squares (LS) Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.8|-1.05|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-1.05|-1.80|<0.001
71825410|NCT04888585|143155203|SUPERIORITY||Least Squares (LS) Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||-0.26|-0.99|<0.001
71825411|NCT04888585|143155204|SUPERIORITY||Least Squares (LS) Mean Difference|-4.56||||0.014|TWO_SIDED|95.0|-8.21|-0.92|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||-0.92|-8.21|0.014
71825412|NCT04888585|143155204|SUPERIORITY||Least Squares (LS) Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.7|-4.31|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-4.31|-11.70|<0.001
71825413|NCT04888585|143155204|SUPERIORITY||Least Squares (LS) Mean Difference|-11.41|||<|0.001|TWO_SIDED|95.0|-15.1|-7.73|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-7.73|-15.10|<0.001
71825414|NCT04888585|143155204|SUPERIORITY||Least Squares (LS) Mean Difference|-5.29||||0.004|TWO_SIDED|95.0|-8.89|-1.69|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-1.69|-8.89|0.004
71825415|NCT04888585|143155205|SUPERIORITY||Response Rate Difference|24.7|||<|0.001|TWO_SIDED|95.0|12.1|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||37.3|12.1|<0.001
71652306|NCT03346070|142823083|SUPERIORITY||Difference in percentage|0.3||||0.935|TWO_SIDED|95.0|-11.1|11.9|||Miettinen & Nurminen method|||||11.9|-11.1|0.935
71886520|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.86||||0.274|TWO_SIDED|90.0|0.73|4.73|||Mixed Models Analysis|||Week 2||4.73|0.73|0.274
71652307|NCT03346070|142823083|SUPERIORITY||Difference in percentage|-2.7||||0.326|TWO_SIDED|95.0|-13.8|7.3|||Miettinen & Nurminen method|||||7.3|-13.8|0.326
71652308|NCT03346070|142823083|SUPERIORITY||Difference in percentage|-1.4||||0.299|TWO_SIDED|95.0|-7.5|3.5|||Miettinen & Nurminen method|||||3.5|-7.5|0.299
71825416|NCT04888585|143155205|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|17.4|42.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||42.9|17.4|<0.001
71825417|NCT04888585|143155205|SUPERIORITY||Response Rate Difference|45.4|||<|0.001|TWO_SIDED|95.0|33.5|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||57.4|33.5|<0.001
71825418|NCT04888585|143155205|SUPERIORITY||Response Rate Difference|24.6|||<|0.001|TWO_SIDED|95.0|11.9|37.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||37.3|11.9|<0.001
71825419|NCT04888585|143155206|SUPERIORITY||Response Rate Difference|6.5||||0.031|TWO_SIDED|95.0|0.6|12.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||12.4|0.6|0.031
71825420|NCT04888585|143155206|SUPERIORITY||Response Rate Difference|9.8||||0.007|TWO_SIDED|95.0|2.7|17.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||17.0|2.7|0.007
71825421|NCT04888585|143155206|SUPERIORITY||Response Rate Difference|10.9||||0.004|TWO_SIDED|95.0|3.6|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||18.2|3.6|0.004
71652309|NCT03346070|142823084|SUPERIORITY||Difference in percentage|0.1|||||TWO_SIDED|95.0|-12.7|13.1|||||Miettinen and Nurminen method|||13.1|-12.7|
71652310|NCT03346070|142823084|SUPERIORITY||Difference in percentage|-3.6|||||TWO_SIDED|95.0|-19.6|12.2|||||Miettinen and Nurminen method|||12.2|-19.6|
71652311|NCT03346070|142823084|SUPERIORITY||Difference in percentage|5.1|||||TWO_SIDED|95.0|-8.1|19.7|||||Miettinen and Nurminen method|||19.7|-8.1|
71652312|NCT03346070|142823084|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-18.0|13.1|||||Miettinen and Nurminen method|||13.1|-18.0|
71652313|NCT03346070|142823084|SUPERIORITY||Difference in percentage|4.4|||||TWO_SIDED|95.0|-9.6|19.2|||||Miettinen and Nurminen method|||19.2|-9.6|
71652314|NCT03346070|142823084|SUPERIORITY||Difference in percentage|2.2|||||TWO_SIDED|95.0|-12.5|17.0|||||Miettinen and Nurminen method|||17.0|-12.5|
71652315|NCT03346070|142823084|SUPERIORITY||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-11.4|7.8|||||Miettinen and Nurminen method|||7.8|-11.4|
71652316|NCT03346070|142823085|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-15.2|9.1|||||Miettinen and Nurminen method|||9.1|-15.2|
71652317|NCT03346070|142823085|SUPERIORITY||Difference in percentage|-8.5|||||TWO_SIDED|95.0|-22.3|1.3|||||Miettinen and Nurminen method|||1.3|-22.3|
71886521|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.83||||0.065|TWO_SIDED|90.0|1.07|3.13|||Mixed Models Analysis|||Week 4||3.13|1.07|0.065
71886522|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.72||||0.252|TWO_SIDED|90.0|0.79|3.75|||Mixed Models Analysis|||Week 8||3.75|0.79|0.252
71825422|NCT04888585|143155206|SUPERIORITY||Response Rate Difference|0.9||||0.709|TWO_SIDED|95.0|-4.0|5.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||5.9|-4.0|0.709
71825423|NCT04888585|143155207|SUPERIORITY||Response Rate Difference|16.9||||0.006|TWO_SIDED|95.0|4.9|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||28.9|4.9|0.006
71825424|NCT04888585|143155207|SUPERIORITY||Response Rate Difference|25.8|||<|0.001|TWO_SIDED|95.0|13.5|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||38.1|13.5|<0.001
71825425|NCT04888585|143155207|SUPERIORITY||Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|18.9|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||44.2|18.9|<0.001
71825426|NCT04888585|143155207|SUPERIORITY||Response Rate Difference|23.2|||<|0.001|TWO_SIDED|95.0|11.0|35.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||35.4|11.0|<0.001
71825427|NCT04888585|143155208|SUPERIORITY||Response Rate Difference|14.1||||0.022|TWO_SIDED|95.0|2.0|26.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||26.2|2.0|0.022
71825428|NCT04888585|143155208|SUPERIORITY||Response Rate Difference|22.8|||<|0.001|TWO_SIDED|95.0|10.0|35.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||35.5|10.0|<0.001
71825429|NCT04888585|143155208|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|11.6|37.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||37.0|11.6|<0.001
71652318|NCT03346070|142823085|SUPERIORITY||Difference in percentage|-5.3|||||TWO_SIDED|95.0|-18.8|6.8|||||Miettinen and Nurminen method|||6.8|-18.8|
71652319|NCT03346070|142823085|SUPERIORITY||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-21.2|1.8|||||Miettinen and Nurminen method|||1.8|-21.2|
71763043|NCT04491604|143027769|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|45.8||||0.00192|TWO_SIDED|95.0|23.6|68.0|||McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (primary wounds with complete healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||68.0|23.6|0.00192
71763044|NCT04491604|143027770|EQUIVALENCE|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data.|responder rate difference|51.0||||0.00047|TWO_SIDED|95.0|29.3|72.6||There is no multiplicity adjustment needed since the hypothesis testing are hierarchical.|McNemar|The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. A multiple imputation approach was used for missing data.|The difference is the treatment/discordance difference in percentage of responders (complete wound healing), which is the same as the difference in the percentage of treatment responders and the percentage of placebo responders.|The null hypothesis of interest was the absence of a treatment effect on wound healing and the alternative hypothesis is the presence of a treatment effect on wound healing. The Hypothesis was tested by exact McNemar's test on the paired primary wound healing data. For subjects with missing primary wound healing data, a multiple imputation approach was used.||72.6|29.3|0.00047
71763045|NCT00373113|143027823|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.002|TWO_SIDED|95.0|1.156|1.869||2-sided log-rank test with the same set of stratification factors. The set of stratification factors included those used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|Null hypothesis is that PFS (median=4.2 months) for sunitinib arm equals PFS for capecitabine arm. The study was designed to have 90% power to detect statistical difference in PFS between two treatment groups assuming the hazard ratio (sunitinib/capecitabine) is 0.75 and both arms follow exponential distribution.||1.869|1.156|0.002
71763046|NCT00373113|143027824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.516|||<|0.001|TWO_SIDED|95.0|1.188|1.933||2-sided log-rank test with the same set of stratification factors that was used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|||1.933|1.188|<0.001
71763047|NCT00373113|143027825|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|11.3|||||TWO_SIDED|95.0|7.6|16.1||||||||16.1|7.6|
71763048|NCT00373113|143027825|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|16.4|||||TWO_SIDED|95.0|12.0|21.6||||||||21.6|12.0|
71763049|NCT00373113|143027825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.049||||0.109|TWO_SIDED|95.0|-11.2|1.1|||Pearson Chi-Square Test|||||1.1|-11.2|0.109
71763050|NCT00373113|143027826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.788||||0.037|TWO_SIDED|95.0|1.042|7.459|||Log Rank|||||7.459|1.042|0.037
71825430|NCT04888585|143155208|SUPERIORITY||Response Rate Difference|12.6||||0.042|TWO_SIDED|95.0|0.5|24.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.7|0.5|0.042
71825431|NCT04888585|143155209|SUPERIORITY||Response Rate Difference|5.1||||0.296|TWO_SIDED|95.0|-4.4|14.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||14.6|-4.4|0.296
71825432|NCT04888585|143155209|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|8.7|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||30.2|8.7|<0.001
71825433|NCT04888585|143155209|SUPERIORITY||Response Rate Difference|25.5|||<|0.001|TWO_SIDED|95.0|14.3|36.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||36.7|14.3|<0.001
71825434|NCT04888585|143155209|SUPERIORITY||Response Rate Difference|14.1||||0.007|TWO_SIDED|95.0|3.8|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||24.5|3.8|0.007
71825435|NCT04888585|143155210|SUPERIORITY||Response Rate Difference|7.1||||0.017|TWO_SIDED|95.0|1.3|13.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 40mg EOW - Placebo|||13.0|1.3|0.017
71825436|NCT04888585|143155210|SUPERIORITY||Response Rate Difference|2.0||||0.424|TWO_SIDED|95.0|-2.8|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||6.8|-2.8|0.424
71825437|NCT04888585|143155210|SUPERIORITY||Response Rate Difference|2.6||||0.303|TWO_SIDED|95.0|-2.3|7.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||7.5|-2.3|0.303
71825438|NCT04888585|143155210|SUPERIORITY||Response Rate Difference|1.3||||0.551|TWO_SIDED|95.0|-2.9|5.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the stratification factors.|Response Rate Difference = ABBV-154 340 E4W - Placebo|||5.4|-2.9|0.551
71825439|NCT04888585|143155211|SUPERIORITY||Least Squares (LS) Mean Difference|-0.18||||0.022|TWO_SIDED|95.0|-0.33|-0.03|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|ABBV-154 40mg EOW - Placebo|||-0.03|-0.33|0.022
71825440|NCT04888585|143155211|SUPERIORITY||Least Squares (LS) Mean Difference|-0.25||||0.001|TWO_SIDED|95.0|-0.41|-0.1|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 150mg EOW - Placebo|||-0.10|-0.41|0.001
71825441|NCT04888585|143155211|SUPERIORITY||Least Squares (LS) Mean Difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg EOW - Placebo|||-0.17|-0.48|<0.001
71825442|NCT04888585|143155211|SUPERIORITY||Least Squares (LS) Mean Difference|-0.21||||0.007|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Models Analysis|MMRM model includes treatment, visit, treatment-by-visit interaction, stratification factors, and the baseline measurement as covariates.|Response Rate Difference = ABBV-154 340mg E4W - Placebo|||-0.06|-0.36|0.007
71825443|NCT05273801|143155217|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||How frequently clinician ask about RPE/HR during session||||0.73
71825444|NCT05273801|143155217|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||How frequently education provided regarding HR/RPE during session||||0.05
71825445|NCT05273801|143155217|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||How frequently HR/RPE target is mentioned in session||||0.007
71825446|NCT05273801|143155217|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||How frequently clinician modifies session/task to reach HR/RPE target||||0.005
71825447|NCT05273801|143155217|SUPERIORITY|||||||1e-05|||||||t-test, 2 sided|||How frequently clinicians monitor HR/RPE during session||||0.00001
71825448|NCT02467491|143155256|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-test||||0.04
71825449|NCT02467491|143155257|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-test||||0.02
71825450|NCT03107611|143155278|SUPERIORITY|||||||0.0817|||||||Fisher Exact|||||||0.0817
71825451|NCT03107611|143155278|SUPERIORITY|||||||0.2874|||||||Fisher Exact|||||||0.2874
71825452|NCT03107611|143155279|EQUIVALENCE|Equivalence margin: -0.20, +0.20|Difference in proportions|-0.03|||||TWO_SIDED|90.0|-0.12|0.06||||||||0.06|-0.12|
71825453|NCT01720446|143155296|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR \<1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).|Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.|Regression, Cox||Semaglutide/Placebo|The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio \[HR\] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.||0.95|0.58|<0.0001
71825454|NCT01720446|143155296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0167|TWO_SIDED|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of no difference.|Regression, Cox||Semaglutide/Placebo|A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.95|0.58|0.0167
71652320|NCT03346070|142823085|SUPERIORITY||Difference in percentage|-2.9|||||TWO_SIDED|95.0|-17.0|10.5|||||Miettinen and Nurminen method|||10.5|-17.0|
71652321|NCT03346070|142823085|SUPERIORITY||Difference in percentage|0.5|||||TWO_SIDED|95.0|-14.0|15.5|||||Miettinen and Nurminen method|||15.5|-14.0|
71825455|NCT01720446|143155297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0016|TWO_SIDED|95.0|0.62|0.89|||Regression, Cox||Semaglutide/Placebo|Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.89|0.62|0.0016
71825456|NCT01720446|143155298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9181|TWO_SIDED|95.0|0.65|1.48|||Regression, Cox||Semaglutide/Placebo|Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.48|0.65|0.9181
71886523|NCT04669678|143293395|OTHER||Odds Ratio (OR)|2.61||||0.002|TWO_SIDED|90.0|1.57|4.33|||Mixed Models Analysis|||Week 12||4.33|1.57|0.002
71704065|NCT03296345|142925741|OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71704066|NCT03296345|142925743|OTHER|A Wilcoxon sign-rank, given non parametric data, was used to compare the intervention and historical control groups for statistical significance, while a student's t-test was used to estimate effect size||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71704067|NCT06100250|142925805|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|0.82||||0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 66|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired STI-related knowledge scores (pre-intervention and post-intervention) is 0||||0.01
71704068|NCT06100250|142925807|OTHER|Paired sample t-test, 2 sided|Mean Difference (Net)|-1.29|||<|0.01|TWO_SIDED|||||A priori threshold for statistical significance = 0.05|Paired sample t-test, 2 sided|Degrees of freedom = 47|Estimation parameter represents the average of the differences between the paired observations (post-intervention score minus pre-intervention score)|Null hypothesis = Mean difference between the paired self-efficacy for specimen self-collection scores (pre-intervention and post-intervention) is 0||||<0.01
71704069|NCT02021318|142925810|NON_INFERIORITY|Non-inferiority of roxadustat versus darbepoetin alfa, margin = -15% (non-inferiority is concluded if the lower limit of the 95% confidence interval of the difference was \>-15%).|Difference in percentage|11.51|||||TWO_SIDED|95.0|5.66|17.36||||||A generalized linear model as an approximation for the Miettinen and Nurminen method, adjusted for stratification factors (actual) was used to estimate the difference of proportions and 95% confidence interval.||17.36|5.66|
71704070|NCT02021318|142925811|NON_INFERIORITY|Non-Inferiority, margin = -0.75 (non-inferiority is concluded if the lower bound of the 95% CI of the least square mean difference (LSM) is \> -0.75 g/dL).|LSM Difference|0.015||||0.839|TWO_SIDED|95.0|-0.131|0.162|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.162|-0.131|0.839
71704071|NCT02021318|142925812|SUPERIORITY||LSM Difference|-0.403|||<|0.001|TWO_SIDED|95.0|-0.51|-0.296|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline LDL, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.296|-0.510|<0.001
71886524|NCT04669678|143293395|OTHER||Odds Ratio (OR)|0.78||||0.46|TWO_SIDED|90.0|0.46|1.34|||Mixed Models Analysis|||Week 20||1.34|0.46|0.460
71704072|NCT02021318|142925813|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.004|TWO_SIDED|95.0|0.26|0.78|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.78|0.26|0.004
71704073|NCT02021318|142925814|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-1.284||||0.027|TWO_SIDED|95.0|-2.423|-0.145|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28) visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PF, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.145|-2.423|0.027
71704074|NCT02021318|142925815|NON_INFERIORITY|Non-Inferiority, margin = -3 (non-inferiority is concluded if the lower bound of the 95% confidence interval of the LSM difference is \> -3 points).|LSM Difference|-0.457||||0.454|TWO_SIDED|95.0|-1.656|0.742|||Mixed Models Analysis|||The model included treatment, visit (weeks 8, 12 and 28), visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 VT, baseline Hb, baseline eGFR as continuous covariates.||0.742|-1.656|0.454
71704075|NCT02021318|142925816|NON_INFERIORITY|Non-Inferiority, margin = 1 mmHg (non-inferiority is concluded if the upper bound of the 95% confidence interval of the LSM difference is \< 1).|LSM Difference|-0.372||||0.547|TWO_SIDED|95.0|-1.587|0.842|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||0.842|-1.587|0.547
71704076|NCT02021318|142925817|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3). Non-Inferiority was declared if the upper bound of the 95% CI is below 1.3.|Hazard Ratio (HR)|0.83||||0.336|TWO_SIDED|95.0|0.56|1.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.22|0.56|0.336
71763051|NCT00373113|143027828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.219|TWO_SIDED|95.0|0.896|1.611||2-sided log-rank test with the same set of stratification factors that were used in the randomization except study sites.|Log Rank|||||1.611|0.896|0.219
71763052|NCT04335136|143027832|OTHER|||||||0.5207||||||The level of significance was 5% (2-sided).|Chi-squared|||"Hypothesis tested: H0: pAPN01 = pPlacebo; H1: pAPN01 ≠ pPlacebo (with p=proportion of patients with event).~A total of 186 patients (93 per group) was estimated to yield 80% power to detect a 20% absolute risk reduction in the primary, from 50% in the placebo group to 30% in the APN01 group, at a 2-sided alpha of 0.05. To consider patients who would be randomized but not treated, a total of 200 patients (100 per group) were planned to be enrolled."||||0.5207
71763053|NCT04335136|143027832|OTHER||Odds Ratio (OR)|0.63||||0.3588|TWO_SIDED|95.0|0.23|1.7|||Regression, Logistic|Degree of freedom: 1||||1.70|0.23|0.3588
71763054|NCT01305577|143027888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.73|||<|0.001|TWO_SIDED|95.0|2.7|8.28|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.28|2.70|<0.001
71886525|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.59||||0.019|TWO_SIDED|90.0|1.15|2.2|||Mixed Models Analysis|||Week 24||2.20|1.15|0.019
71886526|NCT04669678|143293395|OTHER||Odds Ratio (OR)|2.16||||0.061|TWO_SIDED|90.0|1.1|4.27|||Mixed Models Analysis|||Week 2||4.27|1.10|0.061
71763055|NCT01305577|143027888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.21|||<|0.001|TWO_SIDED|95.0|3.52|10.94|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.||10.94|3.52|<0.001
71763056|NCT01305577|143027889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58||||0.028|TWO_SIDED|95.0|1.2|25.87|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||25.87|1.20|0.028
71763057|NCT01305577|143027889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.05|||<|0.001|TWO_SIDED|95.0|2.75|52.9|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||52.90|2.75|<0.001
71763058|NCT01305577|143027890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.001|TWO_SIDED|95.0|1.74|5.14|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.14|1.74|<0.001
71763059|NCT01305577|143027890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.99|9.11|||Regression, Logistic|Logistic regression analysis with treatment and baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.11|2.99|<0.001
71763060|NCT01305577|143027891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.35|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.35|-0.68|<0.001
71763061|NCT01305577|143027891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.50|-0.84|<0.001
71763062|NCT01305577|143027892|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.61|1.47|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.47|0.61|<0.001
71763063|NCT01305577|143027892|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|0.99|1.84|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.84|0.99|<0.001
71763064|NCT01305577|143027893|SUPERIORITY_OR_OTHER||LS mean Difference|-1.68|||<|0.001|TWO_SIDED|95.0|-2.5|-0.87|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.87|-2.50|<0.001
71652322|NCT03346070|142823085|SUPERIORITY||Difference in percentage|-5.5|||||TWO_SIDED|95.0|-13.9|1.2|||||Miettinen and Nurminen method|||1.2|-13.9|
71763065|NCT01305577|143027893|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-2.79|-1.15|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline values as covariate.||||-1.15|-2.79|<0.001
71763066|NCT01305577|143027894|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
71652323|NCT03346070|142823086|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-13.4|7.3|||||Miettinen and Nurminen method|||7.3|-13.4|
71763067|NCT01305577|143027894|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Pearson's chi-square test|||||||<0.001
71763068|NCT06026124|143027930|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763069|NCT06026124|143027930|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763070|NCT06026124|143027931|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763071|NCT06026124|143027931|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763072|NCT06026124|143027932|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763073|NCT06026124|143027932|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763074|NCT06026124|143027933|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
71763075|NCT06026124|143027933|SUPERIORITY||||||<|1e-05|||||||LSD test|||||||<0.00001
71763076|NCT06026124|143027934|SUPERIORITY||||||=|0.17|||||||LSD test|||||||=0.17
71763077|NCT06026124|143027934|SUPERIORITY||||||=|1|||||||LSD test|||||||=1.00
71763078|NCT06026124|143027935|SUPERIORITY||||||<|0.0001|||||||LSD test|||||||<0.0001
71652324|NCT03346070|142823086|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-12.3|10.8|||||Miettinen and Nurminen method|||10.8|-12.3|
71652325|NCT03346070|142823086|SUPERIORITY||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.7|7.0|||||Miettinen and Nurminen method|||7.0|-13.7|
71652326|NCT03346070|142823086|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.2|11.7|||||Miettinen and Nurminen method|||11.7|-11.2|
71652327|NCT03346070|142823086|SUPERIORITY||Difference in percentage|-0.2|||||TWO_SIDED|95.0|-11.5|11.0|||||Miettinen and Nurminen method|||11.0|-11.5|
71652328|NCT03346070|142823086|SUPERIORITY||Difference in percentage|0.2|||||TWO_SIDED|95.0|-11.0|12.0|||||Miettinen and Nurminen method|||12.0|-11.0|
71652329|NCT03346070|142823087|SUPERIORITY||Difference in percentage|3.0|||||TWO_SIDED|95.0|-10.8|16.9|||||Miettinen and Nurminen method|||16.9|-10.8|
71652330|NCT03346070|142823087|SUPERIORITY||Difference in percentage|-76.1|||||TWO_SIDED|95.0|-87.2|-57.6|||||Miettinen and Nurminen method|||-57.6|-87.2|
71652331|NCT03346070|142823087|SUPERIORITY||Difference in percentage|-78.7|||||TWO_SIDED|95.0|-88.8|-61.1|||||Miettinen and Nurminen method|||-61.1|-88.8|
71652332|NCT03346070|142823087|SUPERIORITY||Difference in percentage|2.8|||||TWO_SIDED|95.0|-7.2|14.2|||||Miettinen and Nurminen method|||14.2|-7.2|
71825457|NCT01720446|143155298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1194|TWO_SIDED|95.0|0.51|1.08|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.08|0.51|0.1194
71825458|NCT01720446|143155298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0438|TWO_SIDED|95.0|0.38|0.99|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.99|0.38|0.0438
71825459|NCT01720446|143155298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0027|TWO_SIDED|95.0|0.5|0.86|||Regression, Cox||Semaglutide/Placebo|Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.86|0.50|0.0027
71825460|NCT01720446|143155298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4914|TWO_SIDED|95.0|0.47|1.44|||Regression, Cox||Semaglutide/Placebo|Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.44|0.47|0.4914
71825461|NCT01720446|143155298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5735|TWO_SIDED|95.0|0.77|1.61|||Regression, Cox||Semaglutide/Placcbo|Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||1.61|0.77|0.5735
71825462|NCT01720446|143155299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0292|TWO_SIDED|95.0|0.61|0.97|||Regression, Cox||Semaglutide/Placebo|Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).||0.97|0.61|0.0292
71825463|NCT01720446|143155300|SUPERIORITY_OR_OTHER||Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.52|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.52|-0.80|<0.0001
71825464|NCT01720446|143155300|SUPERIORITY_OR_OTHER||Treatment difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.91|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.91|-1.19|<0.0001
71886527|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.64||||0.106|TWO_SIDED|90.0|0.99|2.71|||Mixed Models Analysis|||Week 4||2.71|0.99|0.106
71652333|NCT03346070|142823087|SUPERIORITY||Difference in percentage|2.9|||||TWO_SIDED|95.0|-4.8|11.0|||||Miettinen and Nurminen method|||11.0|-4.8|
71652334|NCT03346070|142823088|SUPERIORITY||Ratio of geometric means|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Log transformation and t-distribution|||0.86|0.48|
71652335|NCT03346070|142823088|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.06|0.12|||||Log transformation and t-distribution|||0.12|0.06|
71825465|NCT01720446|143155301|SUPERIORITY_OR_OTHER||Treatment difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.38|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.38|-1.06|<0.0001
71825466|NCT01720446|143155301|SUPERIORITY_OR_OTHER||Treatment difference|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.56|-0.88|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-0.88|-1.56|<0.0001
71825467|NCT01720446|143155302|SUPERIORITY_OR_OTHER||Treatment difference|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.47|-2.44|||Mixed Models Analysis||Sema 0.5 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-2.44|-3.47|<0.0001
71825468|NCT01720446|143155302|SUPERIORITY_OR_OTHER||Treatment difference|-4.27|||<|0.0001|TWO_SIDED|95.0|-4.78|-3.75|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-3.75|-4.78|<0.0001
71825469|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.0149|TWO_SIDED|95.0|0.95|1.0|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.00|0.95|0.0149
71825470|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.258|TWO_SIDED|95.0|0.97|1.01|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||1.01|0.97|0.2580
71825471|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.8106|TWO_SIDED|95.0|0.99|1.02|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.02|0.99|0.8106
71886528|NCT04669678|143293395|OTHER||Odds Ratio (OR)|1.77||||0.144|TWO_SIDED|90.0|0.93|3.36|||Mixed Models Analysis|||Week 8||3.36|0.93|0.144
71886529|NCT04669678|143293395|OTHER||Odds Ratio (OR)|2.37||||0.011|TWO_SIDED|90.0|1.36|4.16|||Mixed Models Analysis|||Week 12||4.16|1.36|0.011
71704077|NCT02021318|142925818|SUPERIORITY||LSM Difference|-0.136||||0.818|TWO_SIDED|95.0|-1.299|1.026|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||1.026|-1.299|0.818
71763079|NCT06026124|143027936|SUPERIORITY||||||=|0.51|||||||LSD test|||||||=0.51
71652336|NCT03346070|142823088|SUPERIORITY||Ratio of geometric means|0.14|||||TWO_SIDED|95.0|0.1|0.19|||||Log transformation and t-distribution|||0.19|0.10|
71652337|NCT03346070|142823088|SUPERIORITY||Ratio of geometric means|0.54|||||TWO_SIDED|95.0|0.4|0.71|||||Log transformation and t-distribution|||0.71|0.40|
71652338|NCT03346070|142823088|SUPERIORITY||Ratio of geometric means|0.59|||||TWO_SIDED|95.0|0.48|0.72|||||Log transformation and t-distribution|||0.72|0.48|
71652339|NCT03346070|142823089|SUPERIORITY||Ratio of geometric means|0.63|||||TWO_SIDED|95.0|0.5|0.8|||||Log transformation and t-distribution|||0.80|0.50|
71652340|NCT03346070|142823089|SUPERIORITY||Ratio of geometric means|0.09|||||TWO_SIDED|95.0|0.07|0.13|||||Log transformation and t-distribution|||0.13|0.07|
71652341|NCT03346070|142823089|SUPERIORITY||Ratio of geometric means|0.15|||||TWO_SIDED|95.0|0.11|0.2|||||Log transformation and t-distribution|||0.20|0.11|
71652342|NCT03346070|142823089|SUPERIORITY||Ratio of geometric means|0.56|||||TWO_SIDED|95.0|0.44|0.72|||||Log transformation and t-distribution|||0.72|0.44|
71652343|NCT03346070|142823089|SUPERIORITY||Ratio of geometric means|0.6|||||TWO_SIDED|95.0|0.51|0.7|||||Log transformation and t-distribution|||0.70|0.51|
71652344|NCT03346070|142823090|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.54|0.81|||||Log transformation and t-distribution|||0.81|0.54|
71652345|NCT03346070|142823090|SUPERIORITY||Ratio of geometric means|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Log transformation and t-distribution|||0.17|0.09|
71652346|NCT03346070|142823090|SUPERIORITY||Ratio of geometric means|0.19|||||TWO_SIDED|95.0|0.14|0.27|||||Log transformation and t-distribution|||0.27|0.14|
71704078|NCT02021318|142925819|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.452|TWO_SIDED|95.0|0.6|1.26|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.26|0.60|0.452
71763080|NCT00104520|143027937|SUPERIORITY_OR_OTHER|||||||0.007||0.0||||Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.|Log Rank|||H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, \~210 subjects (70 in each AZLI group, 35 in each placebo group) provided \>90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.||||0.0070
71763081|NCT00104520|143027938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.01||||0.0196|TWO_SIDED|95.0|0.81|9.21||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.||9.21|0.81|0.0196
71763082|NCT00104520|143027939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.28||||0.0012|TWO_SIDED|95.0|2.5|10.06||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).||10.060|2.500|0.0012
71763083|NCT00104520|143027941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659||||0.0059|TWO_SIDED|95.0|-1.125|-0.193|||ANCOVA|ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (\<=2, 4-8, 16-128 or \>=256 μg/mL) value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.||-0.193|-1.125|0.0059
71763084|NCT05188053|143027950|OTHER|"Sample size calculations were performed to estimate the number of subjects needed to detect a 30% difference in NRS pain AUC scores between the study groups.~30% reduction in pain was considered the minimal clinically important difference in pain control based off previous pain research.~A 30% reduction in pain would correspond with a difference of approximately 136 in area under the curve of mean pain over time."||||||0.17||||||a priori threshold p \<0.05|t-test, 2 sided|assuming unequal variance||Two-sample t-test with unequal variance. The null hypothesis is that there was no statistically significant difference between the two treatment groups based on a standard alpha value of 0.05.||||0.170
71763085|NCT02447302|143027956|SUPERIORITY||Difference in least square mean|-0.99|STANDARD_ERROR_OF_MEAN|0.42|=|0.0091|TWO_SIDED|90.0|-1.68|-0.3||The analysis was performed using an analysis of covariance (ANCOVA) model that incorporated treatment, current oral corticosteroid use, prior exposure to tumor necrosis factor alpha (TNFα) antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.30|-1.68|= 0.0091
71763086|NCT02447302|143027956|SUPERIORITY||Difference in least square mean|-0.43|STANDARD_ERROR_OF_MEAN|0.41|=|0.1457|TWO_SIDED|90.0|-1.11|0.24||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the adapted MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.24|-1.11|= 0.1457
71763087|NCT02447302|143027957|SUPERIORITY||MH estimate for difference in percentage|24.4|STANDARD_ERROR_OF_MEAN|8.87|=|0.003|TWO_SIDED|90.0|9.8|39.0||Mantel-Haenszel (MH) estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||39.0|9.8|= 0.003
71825472|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|1.04|||<|0.0001|TWO_SIDED|95.0|1.02|1.06|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.06|1.02|<0.0001
71825473|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|0.96||||0.0185|TWO_SIDED|95.0|0.93|0.99|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.99|0.93|0.0185
71825474|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.5996|TWO_SIDED|95.0|0.96|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|0.96|0.5996
71825475|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|0.97||||0.1833|TWO_SIDED|95.0|0.93|1.01|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.01|0.93|0.1833
71652347|NCT03346070|142823090|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.52|0.83|||||Log transformation and t-distribution|||0.83|0.52|
71652348|NCT03346070|142823090|SUPERIORITY||Ratio of geometric means|0.66|||||TWO_SIDED|95.0|0.57|0.77|||||Log transformation and t-distribution|||0.77|0.57|
71652349|NCT01546142|142823097|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.983|||<|0.001|TWO_SIDED|95.0|2.311|3.849|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||3.849|2.311|<0.001
71652350|NCT01546142|142823098|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|6.271|||<|0.001|TWO_SIDED|95.0|2.908|13.52|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||13.520|2.908|<0.001
71652351|NCT01546142|142823099|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.838|||<|0.001|TWO_SIDED|95.0|3.299|18.622|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||18.622|3.299|<0.001
71652352|NCT01546142|142823100|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
71652353|NCT03919448|142823110|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|101.55||||0.9766|TWO_SIDED|90.0|90.19|114.34||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.34|90.19|0.9766
71652354|NCT03919448|142823110|EQUIVALENCE|The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test-to-reference ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.95||||0.9766|TWO_SIDED|90.0|89.75|113.55||Power of ANOVA: 0,93|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||113.55|89.75|0.9766
71652355|NCT03919448|142823110|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area Under the Serum Concentration-time Curve of Bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|100.59||||0.9766|TWO_SIDED|90.0|88.16|114.77|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||114.77|88.16|0.9766
71652356|NCT03919448|142823111|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.82||||0.3617|TWO_SIDED|90.0|81.21|101.57||Power of ANOVA: 0,95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.57|81.21|0.3617
71704079|NCT02021318|142925820|SUPERIORITY||LSM Difference|0.038||||0.529|TWO_SIDED|95.0|-0.081|0.157|||Mixed Models Analysis|||The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.157|-0.081|0.529
71704080|NCT02021318|142925821|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.001|TWO_SIDED|95.0|1.38|1.96|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on cardiovascular history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.96|1.38|<0.001
71704081|NCT02021318|142925822|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|95.0|1.39|1.98|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.98|1.39|<0.001
71704082|NCT02021318|142925823|SUPERIORITY||LSM Difference|0.051||||0.478|TWO_SIDED|95.0|-0.091|0.194|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.194|-0.091|0.478
71825476|NCT01720446|143155303|SUPERIORITY_OR_OTHER||Treatment ratio|0.93||||0.0009|TWO_SIDED|95.0|0.89|0.97|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.97|0.89|0.0009
71825477|NCT01720446|143155304|SUPERIORITY_OR_OTHER||Treatment ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89|||Mixed Models Analysis||Sema 0.5 mg / Placebo 0.5 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.||0.89|0.68|0.0003
71825478|NCT01720446|143155304|SUPERIORITY_OR_OTHER||Treatment ratio|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Mixed Models Analysis||Sema 1.0 mg / Placebo 1.0 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.81|0.62|<0.0001
71825479|NCT01720446|143155305|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.9205|TWO_SIDED|95.0|-0.83|0.92|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.92|-0.83|0.9205
71825480|NCT01720446|143155305|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.7477|TWO_SIDED|95.0|-0.74|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.03|-0.74|0.7477
71825481|NCT01720446|143155305|SUPERIORITY_OR_OTHER||Treatment difference|-1.27||||0.0976|TWO_SIDED|95.0|-2.77|0.23|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.23|-2.77|0.0976
71825482|NCT01720446|143155305|SUPERIORITY_OR_OTHER||Treatment difference|-2.59||||0.0008|TWO_SIDED|95.0|-4.09|-1.08|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||-1.08|-4.09|0.0008
71825483|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.3171|TWO_SIDED|95.0|-0.48|1.47|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.47|-0.48|0.3171
71825484|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.47||||0.0031|TWO_SIDED|95.0|0.5|2.45|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.45|0.50|0.0031
71825485|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.87||||0.035|TWO_SIDED|95.0|0.06|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|0.06|0.0350
71704083|NCT02021318|142925823|SUPERIORITY||LSM Difference|-0.003||||0.969|TWO_SIDED|95.0|-0.149|0.143|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.143|-0.149|0.969
71704084|NCT02021318|142925823|SUPERIORITY||LSM Difference|0.009||||0.91|TWO_SIDED|95.0|-0.14|0.157|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.140|0.910
71704085|NCT02021318|142925823|SUPERIORITY||LSM Difference|0.024||||0.775|TWO_SIDED|95.0|-0.14|0.188|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.188|-0.140|0.775
71704086|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.087||||0.086|TWO_SIDED|95.0|-0.012|0.185|||Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.012|0.086
71704087|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.278|||<|0.001|TWO_SIDED|95.0|0.165|0.391|||Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.391|0.165|<0.001
71825486|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.42||||0.0007|TWO_SIDED|95.0|0.6|2.24|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.24|0.60|0.0007
71886530|NCT05227690|143293397|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
71652357|NCT03919448|142823111|EQUIVALENCE|The comparable bioavailability was achieved if 90% confidence intervals (CIs) for the test to reference ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|94.87||||0.3617|TWO_SIDED|90.0|84.91|105.99||Power of ANOVA: 0.95|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||105.99|84.91|0.3617
71652358|NCT03919448|142823111|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.73||||0.3617|TWO_SIDED|90.0|84.82|108.05|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||108.05|84.82|0.3617
71652359|NCT03919448|142823112|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|90.46||||0.3529|TWO_SIDED|90.0|80.64|101.47||Power of ANOVA: 0.94|ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||101.47|80.64|0.3529
71652360|NCT03919448|142823112|EQUIVALENCE|80.00-125.00% acceptance criteria.|Hazard Ratio (HR)|95.02||||0.3529|TWO_SIDED|90.0|84.8|106.49||Power of ANOVA: 0.94|ANOVA|||||106.49|84.80|0.3529
71652361|NCT03919448|142823112|EQUIVALENCE|As supplementary information, Test Product 1 vs. Test Product 2 shall also be compared. The comparable bioavailability was achieved if 90 % confidence intervals (CIs) for the test1-to-test2 ratios of the geometric means of Cmax, Area under the serum concentration-time curve of bevacizumab (ABC0-t) fell within the 80.00-125.00 % acceptance criteria.|Hazard Ratio (HR)|95.19||||0.3529|TWO_SIDED|90.0|84.17|107.67|||ANOVA|||The null hypothesis (H0) of ANOVA is that there is no difference among group means. The alternate hypothesis (H1) is that at least one group differs significantly from the overall mean of the dependent variable.||107.67|84.17|0.3529
71652362|NCT01286558|142823125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||||95.0|-0.22|3.14|||ANCOVA|||||3.14|-0.22|
71652363|NCT01286558|142823126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||||95.0|-0.36|4.64|||ANCOVA|||||4.64|-0.36|
71652364|NCT01286558|142823127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||||95.0|-2.58|0.15|||ANCOVA|||||0.15|-2.58|
71652365|NCT01286558|142823128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||||95.0|-4.16|0.35|||ANCOVA|||||0.35|-4.16|
71652366|NCT01286558|142823129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||||95.0|-2.57|0.79|||ANCOVA|||||0.79|-2.57|
71652367|NCT01286558|142823130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-4.27|0.99|||ANCOVA|||||0.99|-4.27|
71652368|NCT03662308|142823144|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71652369|NCT01005329|142823151|OTHER||||||||||||||||||The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.|||
71652370|NCT02997657|142823158|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
71652371|NCT02997657|142823159|SUPERIORITY|||||||0.81|||||||Chi-squared|||||||0.81
71652372|NCT02997657|142823160|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71652373|NCT02997657|142823161|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
71652374|NCT02997657|142823162|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71652375|NCT02997657|142823163|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
71652376|NCT02997657|142823164|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
71652377|NCT01272921|142823165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||<|0.001|TWO_SIDED|95.0|0.49|0.54|||Z score|||||0.54|0.49|<0.001
71652378|NCT01272921|142823165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.001|TWO_SIDED|95.0|0.18|0.21|||Z score|||||0.21|0.18|<0.001
71652379|NCT01272921|142823166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-17.0|-6.0||Post hoc comparison were made against the 30-mL volume group and corrected for 6 comparisons using the Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-17.00|0.05
71704088|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.435|||<|0.001|TWO_SIDED|95.0|0.284|0.586|||Mixed Models Analysis|||Week 4- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.586|0.284|<0.001
71704089|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.422|||<|0.001|TWO_SIDED|95.0|0.254|0.59|||Mixed Models Analysis|||Week 6- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.590|0.254|<0.001
71704090|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.38|||<|0.001|TWO_SIDED|95.0|0.205|0.556|||Mixed Models Analysis|||Week 8- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.556|0.205|<0.001
71704091|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.155|0.505|||Mixed Models Analysis|||Week 10- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.505|0.155|<0.001
71704092|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.3||||0.001|TWO_SIDED|95.0|0.119|0.482|||Mixed Models Analysis|||Week 12- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.482|0.119|0.001
71704093|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.159||||0.079|TWO_SIDED|95.0|-0.018|0.336|||Mixed Models Analysis|||Week 14- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|-0.018|0.079
71763088|NCT02447302|143027957|SUPERIORITY||MH estimate for difference in percentage|4.1|STANDARD_ERROR_OF_MEAN|7.98|=|0.3059|TWO_SIDED|90.0|-9.1|17.2||MH estimated common risk difference adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.2|-9.1|= 0.3059
71763089|NCT02447302|143027958|SUPERIORITY||Difference in least square mean|-0.84|STANDARD_ERROR_OF_MEAN|0.29|=|0.002|TWO_SIDED|90.0|-1.32|-0.36||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.36|-1.32|= 0.0020
71825487|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.7277|TWO_SIDED|95.0|-0.79|1.13|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.13|-0.79|0.7277
71763090|NCT02447302|143027958|SUPERIORITY||Difference in least square mean|-0.39|STANDARD_ERROR_OF_MEAN|0.28|=|0.0858|TWO_SIDED|90.0|-0.85|0.08||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the 2-component MCS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.08|-0.85|= 0.0858
71763091|NCT02447302|143027959|SUPERIORITY||Difference in least square mean|-1.27|STANDARD_ERROR_OF_MEAN|0.55|=|0.01|TWO_SIDED|90.0|-2.17|-0.37||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 2 mg from placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||-0.37|-2.17|= 0.0100
71704094|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.183||||0.044|TWO_SIDED|95.0|0.005|0.361|||Mixed Models Analysis|||Week 16- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.361|0.005|0.044
71704095|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.173||||0.037|TWO_SIDED|95.0|0.01|0.336|||Mixed Models Analysis|||Week 18- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.336|0.010|0.037
71704096|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.085||||0.319|TWO_SIDED|95.0|-0.083|0.253|||Mixed Models Analysis|||Week 20- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.253|-0.083|0.319
71704097|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.03||||0.709|TWO_SIDED|95.0|-0.19|0.129|||Mixed Models Analysis|||Week 22- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.129|-0.190|0.709
71704098|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.061||||0.45|TWO_SIDED|95.0|-0.219|0.097|||Mixed Models Analysis|||Week 24- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.097|-0.219|0.450
71704099|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.065||||0.44|TWO_SIDED|95.0|-0.231|0.101|||Mixed Models Analysis|||Week 28- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.101|-0.231|0.440
71704100|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.014||||0.874|TWO_SIDED|95.0|-0.157|0.184|||Mixed Models Analysis|||Week 32- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.157|0.874
71704101|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.131||||0.132|TWO_SIDED|95.0|-0.039|0.302|||Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.302|-0.039|0.132
71704102|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.187||||0.024|TWO_SIDED|95.0|0.024|0.351|||Mixed Models Analysis|||Week 40- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.351|0.024|0.024
71704103|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.022||||0.807|TWO_SIDED|95.0|-0.153|0.197|||Mixed Models Analysis|||Week 44- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.197|-0.153|0.807
71704104|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.012||||0.89|TWO_SIDED|95.0|-0.16|0.185|||Mixed Models Analysis|||Week 48- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.185|-0.160|0.890
71704105|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.029||||0.746|TWO_SIDED|95.0|-0.201|0.144|||Mixed Models Analysis|||Week 52- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.144|-0.201|0.746
71704106|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.032||||0.715|TWO_SIDED|95.0|-0.202|0.139|||Mixed Models Analysis|||Week 56- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.139|-0.202|0.715
71774896|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.13|STANDARD_ERROR_OF_MEAN|1.64||0.9389|TWO_SIDED|95.0|-3.09|3.34|||ANCOVA|||Baseline sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.34|-3.09|0.9389
71704107|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.066||||0.463|TWO_SIDED|95.0|-0.11|0.242|||Mixed Models Analysis|||Week 60- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.110|0.463
71704108|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.002||||0.987|TWO_SIDED|95.0|-0.187|0.184|||Mixed Models Analysis|||Week 64- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.184|-0.187|0.987
71704109|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.104||||0.251|TWO_SIDED|95.0|-0.074|0.281|||Mixed Models Analysis|||Week 68- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.281|-0.074|0.251
71704110|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.067||||0.473|TWO_SIDED|95.0|-0.117|0.251|||Mixed Models Analysis|||Week 72- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.117|0.473
71704111|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.022||||0.813|TWO_SIDED|95.0|-0.204|0.16|||Mixed Models Analysis|||Week 76- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.160|-0.204|0.813
71704112|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.045||||0.622|TWO_SIDED|95.0|-0.223|0.134|||Mixed Models Analysis|||Week 80- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.134|-0.223|0.622
71704113|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.045||||0.632|TWO_SIDED|95.0|-0.138|0.227|||Mixed Models Analysis|||Week 84- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.227|-0.138|0.632
71704114|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.055||||0.568|TWO_SIDED|95.0|-0.133|0.242|||Mixed Models Analysis|||Week 88- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.242|-0.133|0.568
71704115|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.034||||0.729|TWO_SIDED|95.0|-0.158|0.226|||Mixed Models Analysis|||Week 92- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.226|-0.158|0.729
71704116|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.025||||0.797|TWO_SIDED|95.0|-0.168|0.218|||Mixed Models Analysis|||Week 96- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.218|-0.168|0.797
71704117|NCT02021318|142925824|SUPERIORITY||LSM Difference|-0.11||||0.28|TWO_SIDED|95.0|-0.31|0.09|||Mixed Models Analysis|||Week 100- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.090|-0.310|0.280
71774897|NCT00537238|143050062|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.64|STANDARD_ERROR_OF_MEAN|1.34||0.6344|TWO_SIDED|95.0|-2.0|3.27|||ANCOVA|||Week 16 sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.||3.27|-2.00|0.6344
71774898|NCT00537238|143050063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.016||||0.9285|TWO_SIDED|95.0|0.715|1.444|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.444|0.715|0.9285
71825488|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.97||||0.0489|TWO_SIDED|95.0|0.0|1.94|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.94|0.00|0.0489
71825489|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment Difference|0.61||||0.186|TWO_SIDED|95.0|-0.3|1.53|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.53|-0.30|0.1860
71825490|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.39||||0.0029|TWO_SIDED|95.0|0.48|2.31|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.31|0.48|0.0029
71825491|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.68||||0.0833|TWO_SIDED|95.0|-0.09|1.45|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.45|-0.09|0.0833
71825492|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.4||||0.0004|TWO_SIDED|95.0|0.62|2.17|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.17|0.62|0.0004
71652380|NCT01272921|142823166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-15.0|-6.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-6.00|-15.00|0.05
71652381|NCT01272921|142823166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-10.0|-4.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-4.00|-10.00|0.05
71652382|NCT01272921|142823166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|95.0|-7.0|-2.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.||-2.00|-7.00|0.05
71652383|NCT01567826|142823179|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||||||0.01
71652384|NCT01567826|142823180|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71652385|NCT02062801|142823187|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Chi-squared|||||||0.18
71652386|NCT02062801|142823188|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
71652387|NCT02062801|142823189|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared|||||||.56
71652388|NCT00573170|142823202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.378|TWO_SIDED|95.0|0.7|2.5||Compares odds ratio.|Generalized Estimating Equations|||||2.5|0.7|0.378
71652389|NCT03476317|142823242|EQUIVALENCE|Median difference in calprotectin for controls from day 12 to baseline||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71652390|NCT01483625|142823304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.055||0.3025|TWO_SIDED|95.0|-0.0516|0.1654|||Mixed effect repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Random:Patient. A spatial power covariance structure was used.||Tiotropium 18 mcg minus Placebo||0.1654|-0.0516|0.3025
71704118|NCT02021318|142925824|SUPERIORITY||LSM Difference|0.037||||0.733|TWO_SIDED|95.0|-0.177|0.251|||Mixed Models Analysis|||Week 104- The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit as continuous covariates.||0.251|-0.177|0.733
71652391|NCT01483625|142823305|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|STANDARD_ERROR_OF_MEAN|0.44||0.7823|TWO_SIDED|95.0|0.9053|1.078|||2sample t quantiles with pooled variance|||Comparison Tiotropium 18 mcg Vs Placebo||1.0780|0.9053|0.7823
71652392|NCT01483625|142823306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0099|STANDARD_ERROR_OF_MEAN|0.0806||0.9025|TWO_SIDED|95.0|-0.1489|0.1686||Comparison Tiotropium 18 mcg Vs Placebo at Week 12|Mixed effects repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Patient was random. A spatial power covariance structure was used.||||0.1686|-0.1489|0.9025
71652393|NCT01483625|142823309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.061|STANDARD_ERROR_OF_MEAN|3.0115||0.1797|TWO_SIDED|95.0|-10.0157|1.8938|||t-test, 2 sided|95% confidence interval is based on 2 sample t quantiles using pooled variance.||Comparison Tiotropium 18 mcg Vs Placebo Over 12 Weeks||1.8938|-10.0157|0.1797
71652394|NCT04019054|142823314|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group.||||||0.518|||||||ANOVA|||||||0.518
71652395|NCT04019054|142823315|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is within-group differences.||||||0.008||||||a priori threshold for significance of p=0.05. Observed power η2=0.39.|ANOVA|||||||0.008
71652396|NCT04019054|142823315|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Analysis described here is between-group differences.|||||>|0.05||||||a priori threshold for significance of p=0.05.|ANOVA|||||||>0.05
71763092|NCT02447302|143027959|SUPERIORITY||Difference in least square mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|=|0.1277|TWO_SIDED|90.0|-1.48|0.27||The analysis was performed using an ANCOVA model that incorporated treatment, current oral corticosteroid use, prior exposure to TNFα antagonists, and baseline value as covariate.|ANCOVA|The analysis compared the TMS change from baseline between treatment groups using a 1-sided test at the 0.05 level of significance.|Estimated least square mean difference in etrasimod 1 mg from placebo|||0.27|-1.48|= 0.1277
71763093|NCT02447302|143027960|SUPERIORITY||Odds Ratio (OR)|2.78|||=|0.0071|TWO_SIDED|90.0|1.4|5.51||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||The primary comparison in the study was between etrasimod 2 mg versus placebo.||5.51|1.40|= 0.0071
71763094|NCT02447302|143027960|SUPERIORITY||Odds Ratio (OR)|1.61|||=|0.1192|TWO_SIDED|90.0|0.83|3.14||The analysis was performed using an ordered logistic regression model with terms for treatment, current oral corticosteroid use, and prior exposure to TNFα antagonists.|ANCOVA|The analysis compared the odds of achieving higher trichotomous composite score between the groups using 1-sided test at 0.05 level of significance.||||3.14|0.83|= 0.1192
71763095|NCT02447302|143027961|SUPERIORITY||MH estimate for difference in percentage|25.8|STANDARD_ERROR_OF_MEAN|7.47|=|0.0003|TWO_SIDED|90.0|13.5|38.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||38.1|13.5|= 0.0003
71763096|NCT02447302|143027961|SUPERIORITY||MH estimate for difference in percentage|7.1|STANDARD_ERROR_OF_MEAN|6.46|=|0.136|TWO_SIDED|90.0|-3.5|17.7||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||17.7|-3.5|= 0.1360
71763097|NCT02447302|143027962|SUPERIORITY||MH estimate for difference in percentage|18.9|STANDARD_ERROR_OF_MEAN|9.92|=|0.0282|TWO_SIDED|90.0|2.6|35.3||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 2 mg from Placebo|The primary comparison in the study was between etrasimod 2 mg versus placebo.||35.3|2.6|= 0.0282
71763098|NCT02447302|143027962|SUPERIORITY||MH estimate for difference in percentage|11.4|STANDARD_ERROR_OF_MEAN|10.14|=|0.1309|TWO_SIDED|90.0|-5.3|28.1||The analysis was performed using MH method that was adjusted for current oral corticosteroid therapy at baseline and previous exposure to TNFα antagonists.|Mantel Haenszel|The analysis compared the difference in proportions between treatment groups using a 1-sided test at the 0.05 level of significance.|MH estimated difference in etrasimod 1 mg from Placebo|||28.1|-5.3|= 0.1309
71763099|NCT01901250|143027963|SUPERIORITY_OR_OTHER|||||||0.25|||||||Permutation test|Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.||||||0.25
71886531|NCT05227690|143293397|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
71763100|NCT01400880|143027990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_DEVIATION|3.28|||TWO_SIDED|95.0|1.7|4.27||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.27|1.70|
71763101|NCT01400880|143027990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|2.98|4.92||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.||4.92|2.98|
71763102|NCT02695420|143028013|SUPERIORITY||Treatment Difference|22.1|STANDARD_ERROR_OF_MEAN|6.3||0.0008|TWO_SIDED|95.0|9.6|34.7|||Repeated Measures Model|||||34.7|9.6|0.0008
71763103|NCT02695420|143028013|SUPERIORITY||Treatment Difference|29.3|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|16.3|42.3|||Repeated measures model|||||42.3|16.3|< 0.0001
71763104|NCT02695420|143028013|SUPERIORITY||Treatment Difference|25.5|STANDARD_ERROR_OF_MEAN|6.5||0.0002|TWO_SIDED|95.0|12.6|38.4|||Repeated measures model|||||38.4|12.6|0.0002
71763105|NCT00916929|143028062|SUPERIORITY_OR_OTHER||rate per patient year of follow up|1.5||||||95.0|||||exact method|95% Upper Confidence Limit of objective performance criteria||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate \<1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up."||||
71763106|NCT00916929|143028063|SUPERIORITY_OR_OTHER||sensitivity|50.0|STANDARD_ERROR_OF_MEAN|5.0|||ONE_SIDED|95.0|50.0||||exact method|||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity \> 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%."|||50|
71763107|NCT01742286|143028111|OTHER||MTD/RDE|510.0||||||||||||||||||
71763108|NCT01742286|143028111|OTHER||MTD/RDE|500.0||||||||||||||||||
71763109|NCT02633020|143028127|SUPERIORITY||LS Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|14.7||0.7451|TWO_SIDED|90.0|-30.26|20.56|||ANCOVA|Analysis of covariance (ANCOVA) with baseline % aberrant IELs vs total IELs as a covariate and treatment group as a fixed effect.||||20.56|-30.26|0.7451
71763110|NCT02633020|143028128|SUPERIORITY||LS Mean Difference|-38.22|STANDARD_ERROR_OF_MEAN|27.48||0.1803|TWO_SIDED|95.0|-95.73|19.29|||ANCOVA|ANCOVA model with baseline % aberrant IELs vs intestinal epithelial cells as a covariate and treatment group as a fixed effect.||||19.29|-95.73|0.1803
71763111|NCT02633020|143028129|SUPERIORITY||LS Mean Difference|10.67|STANDARD_ERROR_OF_MEAN|24.0||0.6607|TWO_SIDED|95.0|-38.97|60.31|||ANCOVA|ANCOVA model with baseline VH:CD ratio as a covariate and treatment group as a fixed effect.||||60.31|-38.97|0.6607
71763112|NCT02633020|143028130|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9204|TWO_SIDED|95.0|0.2|6.01|||Regression, Logistic|||||6.01|0.20|0.9204
71763113|NCT02633020|143028131|SUPERIORITY||LS Mean Difference|-12.73|STANDARD_ERROR_OF_MEAN|31.34||0.6885|TWO_SIDED|95.0|-77.57|52.12|||ANCOVA|ANCOVA) model with baseline total IEL counts as a covariate and treatment group as a fixed effect.||||52.12|-77.57|0.6885
71763114|NCT02633020|143028132|SUPERIORITY||Ratio of LS Means|1.17|STANDARD_ERROR_OF_MEAN|0.24||0.4469|TWO_SIDED|95.0|0.77|1.8|||Generalized Linear Mixed Model|Generalized linear mixed model with subject as a random effect and treatment group, time (week) and their interaction as fixed effects.||||1.8|0.77|0.4469
71825493|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.8||||0.0799|TWO_SIDED|95.0|-0.1|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.69|-0.10|0.0799
71825494|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.5||||0.0011|TWO_SIDED|95.0|0.6|2.4|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.40|0.60|0.0011
71763115|NCT02633020|143028134|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4832|TWO_SIDED|95.0|-0.53|0.26|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and time point-by-treatment group as fixed effects.||||0.26|-0.53|0.4832
71763116|NCT02633020|143028135|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.24||0.5561|TWO_SIDED|95.0|-0.64|0.35|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and a time point-by-treatment group as fixed effects.||||0.35|-0.64|0.5561
71763117|NCT01136785|143028136|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||two-sided t test for the change from baseline between the treated and untreated groups.||||0.01
71763118|NCT01136785|143028137|SUPERIORITY_OR_OTHER|||||||0.011|||||||2-sided Paired t-test|||comparing pre and post Interstitial Glucose levels in the active CPAP group||||0.011
71763119|NCT01136785|143028138|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
71763120|NCT01136785|143028139|SUPERIORITY_OR_OTHER|||||||0.754|||||||two-sided paired t-test|||Plasma cortisol pre and post 1-week of active CPAP||||0.754
71825495|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.53||||0.3717|TWO_SIDED|95.0|-0.63|1.68|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.68|-0.63|0.3717
71763121|NCT01136785|143028140|SUPERIORITY_OR_OTHER|||||||0.308|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.308
71763122|NCT01136785|143028141|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group||||0.036
71763123|NCT02954172|143028147|EQUIVALENCE|the equivalence margin of the ORR ratio was set at (0.75, 1.33).|Odds Ratio (OR)|0.9|||||TWO_SIDED|90.0|0.756|1.077||||||||1.077|0.756|
71763124|NCT02954172|143028148|EQUIVALENCE|||||||0.7066|||||||Log Rank|||||||0.7066
71763125|NCT02954172|143028149|EQUIVALENCE|||||||0.3497|||||||Log Rank|||||||0.3497
71763126|NCT01497366|143028154|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.|Difference in percentages|0.3|||||TWO_SIDED|95.0|-7.5|8.0|||||The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.|||8.0|-7.5|
71763127|NCT02745080|143028174|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0719|TWO_SIDED|95.0|0.98|1.72|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.72|0.98|0.0719
71763128|NCT02745080|143028175|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.0001|TWO_SIDED|95.0|1.67|3.71|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||3.71|1.67|<0.0001
71763129|NCT02745080|143028176|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2251|TWO_SIDED|95.0|0.9|1.55|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.55|0.90|0.2251
71763130|NCT02745080|143028177|SUPERIORITY||least squares (LS) mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.038||0.5465|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||Mixed model repeated measures (MMRM) with treatment group, analysis visit as factors, weight/baseline score as covariates, treatment by analysis visit, baseline score by analysis visit as interation terms and unstructured covariance structure|||0.05|-0.10|0.5465
71763131|NCT02745080|143028178|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1498|TWO_SIDED|95.0|0.91|1.87|||Regression, Logistic||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment as a factor and baseline weight as a covariate|||1.87|0.91|0.1498
71763132|NCT00329524|143028180|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis based on paired t-test.|||||<|0.05||95.0|||||t-test, 2 sided|||||||<.05
71763133|NCT00329524|143028181|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||test for order effect|||||||.05
71763134|NCT03818035|143028183|NON_INFERIORITY|One-sided two-group normal approximation Wald Z-test with Mantel-Haenszel stratum weights for 'disease duration' to test for non-inferiority of 100 mg q16w to 100 mg q8w with non-inferiority margin of 10%. Stratified analysis results are reported.|Risk Difference (RD)|-0.6||||0.0013|TWO_SIDED|90.0|-5.7|4.5|||Wald Z-test|||||4.5|-5.7|0.0013
71763135|NCT00982423|143028203|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison between baseline dose of furosemide (3 weeks) versus reduced dose of furosemide (approximately 6 weeks).||||<0.05
71763136|NCT00982423|143028203|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Comparison between GFR taken at baseline dose Furosemide (3 weeks) versus normal GFR||||<0.05
71763137|NCT00982423|143028208|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Comparison between reduced dose Furosemide and baseline dose Furosemide||||0.075
71704119|NCT02021318|142925825|SUPERIORITY||LSM Difference|0.026||||0.727|TWO_SIDED|95.0|-0.119|0.17|||Mixed Models Analysis|||Weeks 28-36 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.170|-0.119|0.727
71704120|NCT02021318|142925825|SUPERIORITY||LSM Difference|-0.001||||0.985|TWO_SIDED|95.0|-0.151|0.148|||Mixed Models Analysis|||Weeks 44-52 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.148|-0.151|0.985
71704121|NCT02021318|142925825|SUPERIORITY||LSM Difference|0.003||||0.965|TWO_SIDED|95.0|-0.148|0.154|||Mixed Models Analysis|||Weeks 72-80 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.154|-0.148|0.965
71704122|NCT02021318|142925825|SUPERIORITY||LSM Difference|-0.016||||0.856|TWO_SIDED|95.0|-0.188|0.157|||Mixed Models Analysis|||Weeks 96-104 - The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline estimated glomerular filtration rate and baseline Hb by visit as continuous covariates.||0.157|-0.188|0.856
71763138|NCT02712047|143028222|OTHER||Ratio|0.36|||||TWO_SIDED|95.0|0.31|0.43|||||Ratio of FF/VI 100/25mcg versus (Vs) Placebo for Day 1, AM|||0.43|0.31|
71763139|NCT02712047|143028222|OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.39|0.28|
71652397|NCT04019054|142823316|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is within-group difference over time.||||||0.004||||||a priori threshold for significance p=0.05. Result above describes within group testing over time. Observed power η2=0.43.|ANOVA|||||||0.004
71652398|NCT04019054|142823316|SUPERIORITY|Repeated-measure MANOVA was utilized to compare control and active group. This allowed for examination between and within each group. Result described here is the between-group comparison|||||>|0.05||||||a priori threshold for significance p=0.05|ANOVA|||||||>0.05
71704123|NCT02021318|142925827|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.22|1.36|<0.001
71763140|NCT02712047|143028222|OTHER||Ratio|0.38|||||TWO_SIDED|95.0|0.32|0.45|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.45|0.32|
71763141|NCT02712047|143028222|OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.31|0.44|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.44|0.31|
71763142|NCT02712047|143028222|OTHER||Ratio|0.46|||||TWO_SIDED|95.0|0.39|0.54|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.54|0.39|
71763143|NCT02712047|143028222|OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.4|0.56|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.56|0.40|
71763144|NCT02712047|143028222|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.66|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.66|0.47|
71652399|NCT04019054|142823317|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.01||||||Threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of skin conductance level (SCL) as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.01
71763145|NCT02712047|143028222|OTHER||Ratio|0.58|||||TWO_SIDED|95.0|0.49|0.69|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.69|0.49|
71763146|NCT02712047|143028222|OTHER||Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.75|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.75|0.53|
71763147|NCT02712047|143028222|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||0.80|0.57|
71763148|NCT02712047|143028222|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||0.80|0.56|
71763149|NCT02712047|143028222|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||0.74|0.52|
71763150|NCT02712047|143028222|OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.71|0.51|
71763151|NCT02712047|143028222|OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, PM|Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM||0.74|0.52|
71763152|NCT02712047|143028222|OTHER||Ratio|0.69|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||0.81|0.58|
71763153|NCT02712047|143028222|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||0.80|0.57|
71763154|NCT02712047|143028222|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.56|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||0.78|0.56|
71763155|NCT02712047|143028222|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||0.80|0.57|
71763156|NCT02712047|143028222|OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||0.78|0.55|
71704124|NCT02021318|142925830|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.079|TWO_SIDED|95.0|0.98|1.5|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.50|0.98|0.079
71704125|NCT02021318|142925831|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.3|TWO_SIDED|95.0|0.79|2.11|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.11|0.79|0.300
71704126|NCT02021318|142925835|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.055|TWO_SIDED|95.0|0.99|2.54|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and Region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI is below 1.0.||2.54|0.99|0.055
71704127|NCT02021318|142925838|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.052|TWO_SIDED|95.0|0.51|1.0|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is below 1.0.||1.00|0.51|0.052
71704128|NCT02021318|142925848|SUPERIORITY||LSM Difference|-1.068||||0.027|TWO_SIDED|95.0|-2.012|-0.124|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||-0.124|-2.012|0.027
71704129|NCT02021318|142925848|SUPERIORITY||LSM Difference|-0.603||||0.239|TWO_SIDED|95.0|-1.606|0.401|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.401|-1.606|0.239
71704130|NCT02021318|142925849|SUPERIORITY||LSM Difference|-0.528||||0.517|TWO_SIDED|95.0|-2.127|1.072|||Mixed Models Analysis|||Weeks 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.072|-2.127|0.517
71704131|NCT02021318|142925849|SUPERIORITY||LSM Difference|-0.947||||0.308|TWO_SIDED|95.0|-2.771|0.877|||Mixed Models Analysis|||Weeks 36-52 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An AnS, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||0.877|-2.771|0.308
71704132|NCT02021318|142925850|SUPERIORITY||LSM Difference|-0.904||||0.57|TWO_SIDED|95.0|-4.032|2.224|||Mixed Models Analysis|||Week 12-28 - The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||2.224|-4.032|0.570
71704133|NCT02021318|142925850|SUPERIORITY||LSM Difference|-1.767||||0.334|TWO_SIDED|95.0|-5.354|1.82|||Mixed Models Analysis|||Weeks 36-52 -The model included treatment, visit, visit by treatment interaction, region and history of cardiovascular disease as fixed class factors and baseline FACT-An total score, baseline Hb, baseline estimated glomerular filtration rate as continuous covariates.||1.820|-5.354|0.334
71704134|NCT02021318|142925852|SUPERIORITY||LSM Difference|0.784||||0.497|TWO_SIDED|95.0|-1.481|3.049|||Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline EQ-5D 5L VAS, baseline Hb, baseline eGFR as continuous covariates.||3.049|-1.481|0.497
71704135|NCT02021318|142925863|SUPERIORITY||LSM Difference|-0.05||||0.902|TWO_SIDED|95.0|-0.93|0.82|||Mixed Models Analysis|||||0.82|-0.93|0.902
71704136|NCT02021318|142925865|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.79|1.29|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.29|0.79|0.960
71704137|NCT02021318|142925867|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.939|TWO_SIDED|95.0|0.79|1.25|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.25|0.79|0.939
71704138|NCT02021318|142925868|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.948|TWO_SIDED|95.0|0.77|1.27|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.27|0.77|0.948
71763157|NCT02712047|143028222|OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||0.81|0.58|
71763158|NCT02712047|143028222|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||0.86|0.61|
71704139|NCT02021318|142925869|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.568|TWO_SIDED|95.0|0.75|1.17|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.17|0.75|0.568
71704140|NCT00441896|142925939|SUPERIORITY|||||||0.7391|||||||ANCOVA|||||||0.7391
71704141|NCT00441896|142925939|SUPERIORITY|||||||0.537|||||||ANCOVA|||||||0.5370
71704142|NCT00441896|142925939|SUPERIORITY|||||||0.908|||||||ANCOVA|||||||0.9080
71763159|NCT02712047|143028222|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||0.86|0.61|
71763160|NCT02712047|143028222|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.85|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||0.85|0.61|
71763161|NCT02712047|143028222|OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||0.84|0.60|
71763162|NCT02712047|143028222|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||0.86|0.61|
71652400|NCT04019054|142823317|SUPERIORITY|||||||0.029||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||The second statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of skin conductance level (SCL) (as a function of step and timepoint).||||0.029
71652401|NCT04019054|142823318|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
71652402|NCT04019054|142823318|SUPERIORITY|||||||0.63||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and timepoint.||||0.63
71652403|NCT04019054|142823318|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
71652404|NCT04019054|142823318|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of group and timepoint.||||<0.001
71704143|NCT00441896|142925939|SUPERIORITY|||||||0.2539|||||||ANCOVA|||||||0.2539
71704144|NCT00441896|142925939|SUPERIORITY|||||||0.6657|||||||ANCOVA|||||||0.6657
71704145|NCT00441896|142925940|SUPERIORITY|||||||0.4249|||||||ANCOVA|||||||0.4249
71704146|NCT00441896|142925940|SUPERIORITY|||||||0.4177|||||||ANCOVA|||||||0.4177
71704147|NCT00441896|142925940|SUPERIORITY|||||||0.3033|||||||ANCOVA|||||||0.3033
71704148|NCT00441896|142925940|SUPERIORITY|||||||0.3014|||||||ANCOVA|||||||0.3014
71704149|NCT00441896|142925940|SUPERIORITY|||||||0.1839|||||||ANCOVA|||||||0.1839
71704150|NCT01350973|142925948|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.876|TWO_SIDED|95.0|-4.2491|4.983||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||4.9830|-4.2491|0.8760
71704151|NCT01350973|142925948|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.35|||<|0.0001|TWO_SIDED|95.0|-15.9442|-6.7637||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA|||||-6.7637|-15.9442|< 0.0001
71704152|NCT02507284|142925959|NON_INFERIORITY|Results for the secondary safety endpoint, adverse events (AEs) in study subjects, was performed using a test for non-inferiority with a threshold of 0.50. The null hypothesis is that the treatment minus placebo proportion difference is greater than (or equal to) the margin of 0.50 and the alternative hypothesis is that the difference is less than 0.50.|Risk Ratio (RR)|0.025||||0.5|ONE_SIDED|97.5|||||t-test, 1 sided|||||||0.50
71704153|NCT01033071|142925968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||<|0.001||95.0|-7.6|-3.1||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.||-3.1|-7.6|<0.001
71704154|NCT01033071|142925968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.2|-4.6||"Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of all treatment groups equal first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level."|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.6|-9.2|<0.001
71704155|NCT01033071|142925971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED|95.0|-9.4|-4.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.7|-9.4|<0.001
71704156|NCT01033071|142925971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-11.5|-6.6||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.6|-11.5|<0.001
71704157|NCT01033071|142925973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-8.5|-4.3||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-4.3|-8.5|<0.001
71704158|NCT01033071|142925973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.0|-6.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.||-6.7|-11.0|<0.001
71704159|NCT00004859|142925989|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Log Rank|||||||0.99
71704160|NCT01258855|142926030|OTHER|||||||0.002|||||||Log Rank|||||||0.002
71704161|NCT01258855|142926031|OTHER|||||||0.43|||||||Log Rank|||||||0.43
71704162|NCT01258855|142926034|OTHER|||||||0.003|||||||Log Rank|||||||0.003
71704163|NCT01258855|142926035|OTHER|||||||0.02|||||||Log Rank|||||||0.02
71704164|NCT01567085|142926037|OTHER|Exact binomial test|||||<|0.001||||||The p-value was calculated from an exact binomial test, where the null hypothesis was that the true failure rate = 40%.|Exact binomial test|Exact 95% confidence interval (3.6, 17.2)||Analysis of post-transplantation treatment failure rate||||< 0.001
71704165|NCT03928704|142926053|SUPERIORITY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|95.0|2.0|6.16|||Regression, Logistic|||||6.16|2.00|<0.001
71763163|NCT02712047|143028222|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||0.93|0.66|
71763164|NCT02712047|143028222|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||0.93|0.66|
71704166|NCT03928704|142926054|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.71|5.54|||Regression, Logistic|||||5.54|1.71|<0.001
71704167|NCT03928704|142926055|SUPERIORITY||LS Mean difference|-1.51|||<|0.001||95.0|-2.04|-0.98|||ANCOVA|||||-0.98|-2.04|<0.001
71704168|NCT03928704|142926055|SUPERIORITY||LS Mean difference|-0.91||||0.22|TWO_SIDED|95.0|-2.42|0.61|||ANCOVA|||||0.61|-2.42|0.220
71704169|NCT03928704|142926056|SUPERIORITY||Odds Ratio (OR)|3.69|||<|0.001|TWO_SIDED|95.0|2.17|6.26|||Regression, Logistic|||||6.26|2.17|<0.001
71704170|NCT03928704|142926057|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.001|TWO_SIDED|95.0|2.06|9.93|||Regression, Logistic|||||9.93|2.06|<0.001
71704171|NCT03928704|142926058|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.41|12.23|||Regression, Logistic|||||12.23|2.41|<0.001
71704172|NCT03928704|142926059|SUPERIORITY||Odds Ratio (OR)|3.31|||<|0.001|TWO_SIDED|95.0|1.87|5.84|||Regression, Logistic|||||5.84|1.87|<0.001
71704173|NCT03928704|142926060|SUPERIORITY||LS Mean difference|-1.48|||<|0.001||95.0|-1.99|-0.97|||ANCOVA|||||-0.97|-1.99|<0.001
71704174|NCT03928704|142926060|SUPERIORITY||LS Mean difference|-1.25||||0.019|TWO_SIDED|95.0|-2.26|-0.24|||ANCOVA|||||-0.24|-2.26|0.019
71704175|NCT03928704|142926061|SUPERIORITY||LS Mean difference|-1.8|||<|0.001||95.0|-2.42|-1.18|||ANCOVA|||||-1.18|-2.42|<0.001
71704176|NCT03928704|142926061|SUPERIORITY||LS Mean difference|-1.09||||0.199|TWO_SIDED|95.0|-2.83|0.65|||ANCOVA|||||0.65|-2.83|0.199
71704177|NCT03928704|142926062|SUPERIORITY||LS Mean difference|-2.63|||<|0.001||95.0|-3.66|-1.61|||ANCOVA|||||-1.61|-3.66|<0.001
71704178|NCT03928704|142926062|SUPERIORITY||LS Mean difference|-1.84||||0.17|TWO_SIDED|95.0|-4.56|0.89|||ANCOVA|||||0.89|-4.56|0.170
71704179|NCT03928704|142926063|SUPERIORITY||LS Mean difference|3.96|||<|0.001|TWO_SIDED|95.0|2.08|5.83|||ANCOVA|||||5.83|2.08|<0.001
71704180|NCT03928704|142926063|SUPERIORITY||LS Mean difference|7.27||||0.035|TWO_SIDED|95.0|0.6|13.95|||ANCOVA|||||13.95|0.60|0.035
71704181|NCT03928704|142926064|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|<0.001
71704182|NCT03928704|142926064|SUPERIORITY||LS Mean difference|-0.5||||0.086|TWO_SIDED|95.0|-1.07|0.07|||ANCOVA|||||0.07|-1.07|0.086
71704183|NCT03928704|142926065|SUPERIORITY||LS Mean difference|-1.06|||=|0.013|TWO_SIDED|95.0|-1.88|-0.23|||ANCOVA|||||-0.23|-1.88|=0.013
71704184|NCT03928704|142926066|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.84|6.62|||Regression, Logistic|||||6.62|1.84|<0.001
71704185|NCT03083379|142926078|EQUIVALENCE|Equivalency is defined as no statistically significant difference in dorsal region redistribution of ventilation following breath cycle 1, 2, and 3 lung expansion therapy sequences.||||||0.9|||||||Mann-Whitney U test|||||||.90
71704186|NCT03403517|142926079|SUPERIORITY||Risk Ratio (RR)|0.859||||0.213|TWO_SIDED|95.0|0.682|1.082|||Fisher Exact|||||1.082|0.682|0.213
71704187|NCT03403517|142926083|SUPERIORITY||Risk Ratio (RR)|0.977|||>|0.999|TWO_SIDED|95.0|0.557|1.715|||Fisher Exact|||||1.715|0.557|>0.999
71704188|NCT03403517|142926084|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.160
71704189|NCT03695094|142926100|OTHER||Geometric mean ratio|0.725|||||TWO_SIDED|90.0|0.586|0.896|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.896|0.586|
71704190|NCT03695094|142926102|OTHER||Geometric mean ratio|0.636|||||TWO_SIDED|90.0|0.504|0.801|||ANOVA|||The analysis of variance model (ANOVA) included the fixed effects of treatment group. The natural logs were taken of the dependent variables and were back-transformed after the analysis. The geometric mean ratio and the respective 90% confidence interval (CI) was derived for the Inducers group vs the Neutral-control group from the ANOVA model using least-squares means difference.||0.801|0.504|
71704191|NCT01779362|142926123|SUPERIORITY||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.||||>0.05
71704192|NCT01779362|142926124|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
71704193|NCT01779362|142926125|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
71704194|NCT01779362|142926126|SUPERIORITY||||||<|0.001||||||For all 3 secondary outcomes at M12, p\<0.001, with the Liraglutide+Metformin group different from the 3 others (all p\<0.001).|ANOVA|||Analyses were completed on a log scale and re-exponentiated for display.||||<0.001
71704195|NCT01795937|142926127|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|198.55|STANDARD_DEVIATION|14.2|||TWO_SIDED|90.0|182.43|216.09|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir||216.09|182.43|
71704196|NCT01795937|142926128|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|180.63|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|165.68|196.93|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir.||196.93|165.68|
71704197|NCT01795937|142926129|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|946.45|STANDARD_DEVIATION|27.3|||TWO_SIDED|90.0|797.61|1123.07|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1123.07|797.61|
71704198|NCT01795937|142926130|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3372.72|STANDARD_DEVIATION|20.5|||TWO_SIDED|90.0|2961.95|3840.47|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||3840.47|2961.95|
71704199|NCT01795937|142926133|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1358.91|STANDARD_DEVIATION|16.4|||TWO_SIDED|90.0|1224.32|1508.29|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.||1508.29|1224.32|
71704200|NCT01795937|142926134|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1466.35|STANDARD_DEVIATION|23.3|||TWO_SIDED|90.0|1277.62|1682.95|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1682.95|1277.62|
71763165|NCT02712047|143028222|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.56|0.79|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||0.79|0.56|
71763166|NCT02712047|143028222|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||0.93|0.66|
71763167|NCT02712047|143028222|OTHER||Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||0.94|0.66|
71763168|NCT02712047|143028222|OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.87|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||0.87|0.62|
71886532|NCT05227690|143293398|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
71763169|NCT02712047|143028222|OTHER||Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||0.86|0.61|
71763170|NCT02712047|143028222|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||0.91|0.65|
71763171|NCT02712047|143028222|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.01|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||1.01|0.65|
71763172|NCT02712047|143028222|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||0.96|0.61|
71763173|NCT02712047|143028222|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.59|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||1.00|0.59|
71763174|NCT02712047|143028222|OTHER||Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.05|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||1.05|0.63|
71763175|NCT02712047|143028222|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.52|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||1.00|0.52|
71763176|NCT02712047|143028222|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.56|1.09|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||1.09|0.56|
71763177|NCT02712047|143028222|OTHER||Ratio|0.78|||||TWO_SIDED|95.0|0.53|1.14|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||1.14|0.53|
71763178|NCT02712047|143028222|OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.59|1.22|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||1.22|0.59|
71763179|NCT02712047|143028222|OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.5|1.13|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||1.13|0.50|
71763180|NCT02712047|143028222|OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.55|1.25|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, AM|||1.25|0.55|
71763181|NCT02712047|143028222|OTHER||Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.16|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, PM|||1.16|0.51|
71763182|NCT02712047|143028222|OTHER||Ratio|0.99|||||TWO_SIDED|95.0|0.66|1.49|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, AM|||1.49|0.66|
71763183|NCT02712047|143028222|OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.29|1.51|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, PM|||1.51|0.29|
71763184|NCT02712047|143028222|OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.32|1.64|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 24, AM|||1.64|0.32|
71763185|NCT02712047|143028224|OTHER||Mean Difference (Net)|45.86|||||TWO_SIDED|95.0|23.69|68.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||68.03|23.69|
71763186|NCT02712047|143028224|OTHER||Mean Difference (Net)|45.37|||||TWO_SIDED|95.0|23.2|67.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||67.55|23.20|
71763187|NCT02712047|143028224|OTHER||Mean Difference (Net)|34.03|||||TWO_SIDED|95.0|11.86|56.21|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||56.21|11.86|
71763188|NCT02712047|143028224|OTHER||Mean Difference (Net)|31.56|||||TWO_SIDED|95.0|9.38|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||53.73|9.38|
71763189|NCT02712047|143028224|OTHER||Mean Difference (Net)|22.86|||||TWO_SIDED|95.0|0.68|45.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||45.03|0.68|
71763190|NCT02712047|143028224|OTHER||Mean Difference (Net)|36.94|||||TWO_SIDED|95.0|14.77|59.12|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||59.12|14.77|
71763191|NCT02712047|143028224|OTHER||Mean Difference (Net)|19.33|||||TWO_SIDED|95.0|-3.0|41.66|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||41.66|-3.00|
71763192|NCT02712047|143028224|OTHER||Mean Difference (Net)|20.85|||||TWO_SIDED|95.0|-1.32|43.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||43.03|-1.32|
71763193|NCT02712047|143028224|OTHER||Mean Difference (Net)|16.82|||||TWO_SIDED|95.0|-5.47|39.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||39.11|-5.47|
71763194|NCT02712047|143028224|OTHER||Mean Difference (Net)|21.86|||||TWO_SIDED|95.0|-0.41|44.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, PM|||44.14|-0.41|
71763195|NCT02712047|143028224|OTHER||Mean Difference (Net)|13.05|||||TWO_SIDED|95.0|-9.57|35.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, AM|||35.67|-9.57|
71763196|NCT02712047|143028224|OTHER||Mean Difference (Net)|28.68|||||TWO_SIDED|95.0|5.38|51.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, PM|||51.98|5.38|
71763197|NCT02712047|143028224|OTHER||Mean Difference (Net)|17.09|||||TWO_SIDED|95.0|-5.08|39.26|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||39.26|-5.08|
71763198|NCT02712047|143028224|OTHER||Mean Difference (Net)|23.61|||||TWO_SIDED|95.0|0.28|46.94|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, PM|||46.94|0.28|
71763199|NCT02712047|143028224|OTHER||Mean Difference (Net)|12.87|||||TWO_SIDED|95.0|-9.3|35.05|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, AM|||35.05|-9.30|
71763200|NCT02712047|143028224|OTHER||Mean Difference (Net)|7.5|||||TWO_SIDED|95.0|-14.67|29.68|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, PM|||29.68|-14.67|
71704201|NCT01795937|142926135|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3288.7|STANDARD_DEVIATION|28.5|||TWO_SIDED|90.0|2782.04|3887.63|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||3887.63|2782.04|
71704202|NCT01795937|142926136|NON_INFERIORITY_OR_EQUIVALENCE|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1678.23|STANDARD_DEVIATION|22.6|||TWO_SIDED|90.0|1468.52|1917.89|||ANOVA|ANOVA with fixed effect for treatment and random effect for subject.|The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.||1917.89|1468.52|
71704203|NCT00983957|142926149|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.105|||||TWO_SIDED|90.0|1.023|1.195|||||Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.195|1.023|
71704204|NCT00983957|142926150|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.071|||||TWO_SIDED|90.0|0.988|1.16|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.160|0.988|
71704205|NCT00983957|142926151|SUPERIORITY_OR_OTHER||Adjusted geometric mean|1.009|||||TWO_SIDED|90.0|0.951|1.07|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.070|0.951|
71704206|NCT00983957|142926152|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.121|||||TWO_SIDED|90.0|1.018|1.234|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.234|1.018|
71704207|NCT00983957|142926155|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.059|||||TWO_SIDED|90.0|0.988|1.135|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.135|0.988|
71704208|NCT00983957|142926160|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.115|||||TWO_SIDED|90.0|1.063|1.171|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.||1.171|1.063|
71704209|NCT03676725|142926242|SUPERIORITY||Odds Ratio (OR)|5.17||||0.017|ONE_SIDED||||||Fisher Exact|||Women with PMS vs. without PMS.||||0.017
71704210|NCT03676725|142926242|SUPERIORITY||Odds Ratio (OR)|16.0||||0.001|TWO_SIDED||||||Fisher Exact|||Women with PMS and with ADHD vs. other women||||0.001
71704211|NCT03676725|142926242|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8|TWO_SIDED||||||Fisher Exact|||ADHD vs. no ADHD||||0.8
71704212|NCT01579305|142926249|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.|Difference in responder rates|4.9|||||ONE_SIDED|97.5|-6.7||||||Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.|The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.|||-6.7|
71704213|NCT03446573|142926268|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.|Adjusted difference in proportion (ADP)|-0.3|||||TWO_SIDED|95.0|-1.2|0.7|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.7|-1.2|
71704214|NCT03446573|142926269|NON_INFERIORITY|Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.|Adjusted difference in proportion|0.2|||||TWO_SIDED|95.0|-3.4|3.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).|||3.9|-3.4|
71704215|NCT03446573|142926295|OTHER||Treatment ratio|1.057||||0.257|TWO_SIDED|95.0|0.96|1.164|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.|||1.164|0.960|0.257
71704216|NCT03446573|142926295|OTHER||Treatment ratio|1.062||||0.35|TWO_SIDED|95.0|0.936|1.205|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.|||1.205|0.936|0.350
71704217|NCT03446573|142926295|OTHER||Treatment ratio|0.979||||0.473|TWO_SIDED|95.0|0.924|1.037|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.|||1.037|0.924|0.473
71763201|NCT02712047|143028224|OTHER||Mean Difference (Net)|3.32|||||TWO_SIDED|95.0|-19.11|25.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, AM|||25.74|-19.11|
71763202|NCT02712047|143028224|OTHER||Mean Difference (Net)|3.83|||||TWO_SIDED|95.0|-18.34|26.0|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, PM|||26.00|-18.34|
71763203|NCT02712047|143028224|OTHER||Mean Difference (Net)|11.36|||||TWO_SIDED|95.0|-11.11|33.82|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, AM|||33.82|-11.11|
71704218|NCT03446573|142926295|OTHER||Treatment ratio|0.956||||0.212|TWO_SIDED|95.0|0.891|1.026|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.|||1.026|0.891|0.212
71704219|NCT03446573|142926297|OTHER||Treatment ratio|0.977||||0.7|TWO_SIDED|95.0|0.866|1.102|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 96 has been presented.|||1.102|0.866|0.700
71704220|NCT03446573|142926297|OTHER||Treatment ratio|0.971||||0.7|TWO_SIDED|95.0|0.835|1.129|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 144 has been presented.|||1.129|0.835|0.700
71704221|NCT03446573|142926297|OTHER||Treatment ratio|0.969||||0.356|TWO_SIDED|95.0|0.907|1.036|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 96 has been presented.|||1.036|0.907|0.356
71704222|NCT03446573|142926297|OTHER||Treatment ratio|0.991||||0.814|TWO_SIDED|95.0|0.916|1.071|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 144 has been presented.|||1.071|0.916|0.814
71704223|NCT03446573|142926298|OTHER||Treatment ratio|0.958||||0.56|TWO_SIDED|95.0|0.83|1.106|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.|||1.106|0.830|0.560
71704224|NCT03446573|142926298|OTHER||Treatment ratio|1.055||||0.489|TWO_SIDED|95.0|0.906|1.229|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.|||1.229|0.906|0.489
71704225|NCT03446573|142926300|OTHER||Treatment ratio|1.165||||0.081|TWO_SIDED|95.0|0.981|1.384|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 96 has been presented.|||1.384|0.981|0.081
71704226|NCT03446573|142926300|OTHER||Treatment ratio|0.981||||0.834|TWO_SIDED|95.0|0.819|1.175|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 144 has been presented.|||1.175|0.819|0.834
71704227|NCT03446573|142926301|OTHER||Treatment ratio|1.017||||0.758|TWO_SIDED|95.0|0.915|1.13|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.|||1.130|0.915|0.758
71704228|NCT03446573|142926301|OTHER||Treatment ratio|0.999||||0.985|TWO_SIDED|95.0|0.894|1.116|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.|||1.116|0.894|0.985
71704229|NCT03446573|142926303|OTHER||Treatment ratio|1.015||||0.806|TWO_SIDED|95.0|0.904|1.139|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 96 has been presented.|||1.139|0.904|0.806
71704230|NCT03446573|142926303|OTHER||Treatment ratio|1.019||||0.745|TWO_SIDED|95.0|0.909|1.142|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 144 has been presented.|||1.142|0.909|0.745
71704231|NCT03446573|142926304|OTHER||Treatment ratio|0.935||||0.264|TWO_SIDED|95.0|0.83|1.052|||Mixed Model Reported Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.|||1.052|0.830|0.264
71704232|NCT03446573|142926304|OTHER||Treatment ratio|0.996||||0.932|TWO_SIDED|95.0|0.903|1.098|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.|||1.098|0.903|0.932
71704233|NCT03446573|142926306|OTHER||Treatment ratio|1.15||||0.011|TWO_SIDED|95.0|1.032|1.281|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 96 has been presented.|||1.281|1.032|0.011
71704234|NCT03446573|142926306|OTHER||Treatment ratio|1.007||||0.895|TWO_SIDED|95.0|0.905|1.121|||Mixed Model Repeated Measures||Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 144 has been presented.|||1.121|0.905|0.895
71704235|NCT03446573|142926314|OTHER||Mean Difference (Net)|0.29||||0.047|TWO_SIDED|95.0|0.0|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented|||0.57|0.00|0.047
71704236|NCT03446573|142926314|OTHER||Mean Difference (Net)|0.31||||0.094|TWO_SIDED|95.0|-0.05|0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented|||0.68|-0.05|0.094
71704237|NCT03446573|142926314|OTHER||Mean Difference (Net)|-1.34|||<|0.001|TWO_SIDED|95.0|-2.01|-0.68|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented|||-0.68|-2.01|<0.001
71704238|NCT03446573|142926314|OTHER||Mean Difference (Net)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.59|-1.09|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented|||-1.09|-2.59|<0.001
71704239|NCT03446573|142926314|OTHER||Mean Difference (Net)|2.1||||0.066|TWO_SIDED|95.0|-0.1|4.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented|||4.3|-0.1|0.066
71704240|NCT03446573|142926314|OTHER||Mean Difference (Net)|2.9||||0.046|TWO_SIDED|95.0|0.0|5.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented|||5.8|0.0|0.046
71704241|NCT03446573|142926314|OTHER||Mean Difference (Net)|0.0381||||0.005|TWO_SIDED|95.0|0.0117|0.0646|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented|||0.0646|0.0117|0.005
71704242|NCT03446573|142926314|OTHER||Mean Difference (Net)|0.0292||||0.032|TWO_SIDED|95.0|0.0025|0.0559|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented|||0.0559|0.0025|0.032
71704243|NCT03446573|142926316|OTHER||Mean Difference (Net)|0.17||||0.386|TWO_SIDED|95.0|-0.22|0.57|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 96 has been presented|||0.57|-0.22|0.386
71704244|NCT03446573|142926316|OTHER||Mean Difference (Net)|0.14||||0.573|TWO_SIDED|95.0|-0.34|0.61|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 144 has been presented|||0.61|-0.34|0.573
71704245|NCT03446573|142926316|OTHER||Mean Difference (Net)|-1.87|||<|0.001|TWO_SIDED|95.0|-2.7|-1.04|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 96 has been presented|||-1.04|-2.70|< 0.001
71763204|NCT02712047|143028224|OTHER||Mean Difference (Net)|27.73|||||TWO_SIDED|95.0|5.43|50.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, PM|||50.03|5.43|
71704246|NCT03446573|142926316|OTHER||Mean Difference (Net)|-1.95|||<|0.001|TWO_SIDED|95.0|-2.77|-1.14|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 144 has been presented|||-1.14|-2.77|< 0.001
71704247|NCT03446573|142926316|OTHER||Mean Difference (Net)|2.1||||0.082|TWO_SIDED|95.0|-0.3|4.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 96 has been presented.|||4.4|-0.3|0.082
71704248|NCT03446573|142926316|OTHER||Mean Difference (Net)|0.4||||0.765|TWO_SIDED|95.0|-2.3|3.2|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 144 has been presented|||3.2|-2.3|0.765
71704249|NCT03446573|142926316|OTHER||Mean Difference (Net)|0.0151||||0.301|TWO_SIDED|95.0|-0.0136|0.0438|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 96 has been presented|||0.0438|-0.0136|0.301
71704250|NCT03446573|142926316|OTHER||Mean Difference (Net)|0.0126||||0.34|TWO_SIDED|95.0|-0.0133|0.0384|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 144 has been presented|||0.0384|-0.0133|0.340
71704251|NCT03446573|142926317|OTHER||Mean Difference (Net)|-2.2||||0.173|TWO_SIDED|95.0|-5.3|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented|||1.0|-5.3|0.173
71704252|NCT03446573|142926317|OTHER||Mean Difference (Net)|-2.3||||0.168|TWO_SIDED|95.0|-5.5|1.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented|||1.0|-5.5|0.168
71704253|NCT03446573|142926319|OTHER||Mean Difference (Net)|-9.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 96 has been presented.|||-4.7|-14.0|<0.001
71704254|NCT03446573|142926319|OTHER||Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.4|-1.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 144 has been presented.|||-1.7|-9.4|0.005
71704255|NCT03446573|142926320|OTHER||Mean Difference (Net)|-0.01||||0.027|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented|||0.00|-0.03|0.027
71704256|NCT03446573|142926320|OTHER||Mean Difference (Net)|-0.01||||0.061|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented|||0.00|-0.03|0.061
71704257|NCT03446573|142926322|OTHER||Mean Difference (Net)|-0.03||||0.004|TWO_SIDED|95.0|-0.06|-0.01|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 96 has been presented|||-0.01|-0.06|0.004
71763205|NCT02712047|143028224|OTHER||Mean Difference (Net)|14.71|||||TWO_SIDED|95.0|-7.57|36.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, AM|||36.98|-7.57|
71763206|NCT02712047|143028224|OTHER||Mean Difference (Net)|-6.62|||||TWO_SIDED|95.0|-28.8|15.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, PM|||15.55|-28.80|
71763207|NCT02712047|143028224|OTHER||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-18.39|27.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, AM|||27.11|-18.39|
71704258|NCT03446573|142926322|OTHER||Mean Difference (Net)|-0.01||||0.094|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 144 has been presented|||0.00|-0.03|0.094
71763208|NCT02712047|143028224|OTHER||Mean Difference (Net)|8.29|||||TWO_SIDED|95.0|-13.99|30.57|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, PM|||30.57|-13.99|
71763209|NCT02712047|143028224|OTHER||Mean Difference (Net)|0.64|||||TWO_SIDED|95.0|-21.64|22.92|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, AM|||22.92|-21.64|
71763210|NCT02712047|143028224|OTHER||Mean Difference (Net)|-6.88|||||TWO_SIDED|95.0|-29.96|16.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, PM|||16.19|-29.96|
71763211|NCT02712047|143028224|OTHER||Mean Difference (Net)|28.45|||||TWO_SIDED|95.0|5.76|51.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, AM|||51.13|5.76|
71763212|NCT02712047|143028224|OTHER||Mean Difference (Net)|12.31|||||TWO_SIDED|95.0|-10.13|34.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, PM|||34.74|-10.13|
71763213|NCT02712047|143028224|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-18.16|26.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, AM|||26.36|-18.16|
71763214|NCT02712047|143028224|OTHER||Mean Difference (Net)|18.87|||||TWO_SIDED|95.0|-3.89|41.63|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, PM|||41.63|-3.89|
71763215|NCT02712047|143028224|OTHER||Mean Difference (Net)|6.35|||||TWO_SIDED|95.0|-16.17|28.88|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, AM|||28.88|-16.17|
71763216|NCT02712047|143028224|OTHER||Mean Difference (Net)|19.07|||||TWO_SIDED|95.0|-3.27|41.41|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, PM|||41.41|-3.27|
71763217|NCT02712047|143028224|OTHER||Mean Difference (Net)|29.51|||||TWO_SIDED|95.0|6.87|52.15|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, AM|||52.15|6.87|
71763218|NCT02712047|143028224|OTHER||Mean Difference (Net)|9.64|||||TWO_SIDED|95.0|-17.91|37.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, PM|||37.19|-17.91|
71763219|NCT02712047|143028224|OTHER||Mean Difference (Net)|24.77|||||TWO_SIDED|95.0|-4.2|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, AM|||53.73|-4.20|
71763220|NCT02712047|143028224|OTHER||Mean Difference (Net)|47.04|||||TWO_SIDED|95.0|14.63|79.45|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, PM|||79.45|14.63|
71763221|NCT02712047|143028224|OTHER||Mean Difference (Net)|20.11|||||TWO_SIDED|95.0|-12.3|52.52|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, AM|||52.52|-12.30|
71763222|NCT02712047|143028224|OTHER||Mean Difference (Net)|25.13|||||TWO_SIDED|95.0|-15.02|65.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, PM|||65.27|-15.02|
71763223|NCT02712047|143028224|OTHER||Mean Difference (Net)|-7.89|||||TWO_SIDED|95.0|-48.04|32.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, AM|||32.25|-48.04|
71763224|NCT02712047|143028224|OTHER||Mean Difference (Net)|8.51|||||TWO_SIDED|95.0|-37.22|54.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, PM|||54.25|-37.22|
71763225|NCT02712047|143028224|OTHER||Mean Difference (Net)|15.08|||||TWO_SIDED|95.0|-28.5|58.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||58.67|-28.50|
71704259|NCT03446573|142926323|OTHER||Mean Difference (Net)|1.8||||0.012|TWO_SIDED|95.0|0.4|3.1|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented|||3.1|0.4|0.012
71652405|NCT04019054|142823318|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of anticipatory distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
71652406|NCT04019054|142823318|SUPERIORITY|||||||0.047||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of anticipatory distress as a function of step and group.||||0.047
71652407|NCT04019054|142823319|SUPERIORITY||Mann Whitney U statistic|13.5|STANDARD_ERROR_OF_MEAN|9.58||0.027|TWO_SIDED|||||a priori threshold for significance of p=0.05|Wilcoxon (Mann-Whitney)|||2-sided Mann-Whitney U Test (nonparametric) utilized to compare the ability of the groups to tolerate treatment intensity.||||0.027
71652408|NCT04019054|142823321|OTHER|A pair of chi-square analyses were performed to validate blinding of the study (based on questionnaires completed by subjects and raters). Given the small sample size, Fisher's exact method was utilized. The number of correct and incorrect guesses for each group were examined once for the subject guesses and once for the rater's guesses.|||||>|0.05|||||||Fisher Exact|For the subjects, p=0.64 using Fisher's exact method. For the raters, p=1 using Fisher's exact method.||||||>.05
71652409|NCT04019054|142823322|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
71652410|NCT04019054|142823322|SUPERIORITY||||||>|0.05||||||a priori threshold for significance of 0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and timepoint.||||>.05
71652411|NCT04019054|142823322|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance of p=0.05|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of treatment group and timepoint. This multi-level model was generated using the menbreg function in Stata 16||||<.001
71704260|NCT03446573|142926323|OTHER||Mean Difference (Net)|1.6||||0.059|TWO_SIDED|95.0|-0.1|3.3|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented|||3.3|-0.1|0.059
71704261|NCT03446573|142926323|OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-6.3|-3.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented|||-3.7|-6.3|<0.001
71704262|NCT03446573|142926323|OTHER||Mean Difference (Net)|-4.8|||<|0.001|TWO_SIDED|95.0|-6.1|-3.4|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented|||-3.4|-6.1|<0.001
71704263|NCT03446573|142926325|OTHER||Mean Difference (Net)|4.1||||0.002|TWO_SIDED|95.0|1.5|6.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 96 has been presented|||6.7|1.5|0.002
71704264|NCT03446573|142926325|OTHER||Mean Difference (Net)|1.9||||0.064|TWO_SIDED|95.0|-0.1|3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 148 has been presented|||3.8|-0.1|0.064
71704265|NCT03446573|142926325|OTHER||Mean Difference (Net)|-5.2|||<|0.001|TWO_SIDED|95.0|-6.7|-3.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 96 has been presented|||-3.8|-6.7|<0.001
71704266|NCT03446573|142926325|OTHER||Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.2|-2.8|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 144 has been presented|||-2.8|-6.2|<0.001
71704267|NCT03446573|142926326|OTHER||Mean Difference (Net)|4.37|||<|0.001|TWO_SIDED|95.0|3.03|5.7|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.|||5.70|3.03|<0.001
71763226|NCT02712047|143028224|OTHER||Mean Difference (Net)|5.19|||||TWO_SIDED|95.0|-45.35|55.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, PM|||55.73|-45.35|
71652412|NCT04019054|142823322|SUPERIORITY||||||<|0.001||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of group and timepoint.||||<.001
71652413|NCT04019054|142823322|OTHER|This was a goodness of fit test of a multi-level model, fit was tested using a wald chi-square test.|||||<|0.001||||||a priori threshold for significance was p=0.05.|Chi-squared|This was specifically a wald chi-square test, performed in Stata for the purpose of assessing goodness-of-fit of a mixed effects model||Goodness of fit test of a two-variable negative binomial multi-level model of maximum distress as a function of step and group. This multi-level model was generated using the menbreg function in Stata 16||||<0.001
71652414|NCT04019054|142823322|SUPERIORITY|||||||0.024||||||a priori threshold for significance of p=0.05|Mixed Models Analysis|||This statistical analysis involved testing of the step-by-timepoint interaction in the two-variable negative binomial model of maximum distress as a function of step and group.||||0.024
71652415|NCT05444543|142823323|SUPERIORITY||Odds Ratio (OR)|0.089||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
71652416|NCT05444543|142823324|SUPERIORITY||Odds Ratio (OR)|1.1|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
71825496|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.94||||0.1136|TWO_SIDED|95.0|-0.22|2.1|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.10|-0.22|0.1136
71652417|NCT04625062|142823342|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.72|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Traditional treatment condition - biofeedback treatment condition|||||.72
71652418|NCT00860743|142823343|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P values less than 0.05 are considered statistically significant in this study.|ANOVA|||||||0.001
71652419|NCT00860743|142823344|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.2
71652420|NCT03827018|142823345|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0263|TWO_SIDED|95.0|0.15|0.92||Comparison of KPL-301 and placebo with respect to time to flare calculated by using a log-rank test stratified by randomization strata.|Log Rank||95% confidence interval was calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata.|||0.92|0.15|0.0263
71652421|NCT03827018|142823346|SUPERIORITY||Difference in proportions|33.3||||0.0038|TWO_SIDED|95.0|10.7|55.8||Two-sided p-value and 95% CI for the difference in sustained remission between two arms using normal approximation. Placebo arm is the reference.|normal approximation|||Secondary endpoints were analyzed in hierarchical order.||55.8|10.7|0.0038
71652422|NCT03827018|142823347|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0277|TWO_SIDED|95.0|0.27|0.95||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.95|0.27|0.0277
71652423|NCT03827018|142823348|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0378|TWO_SIDED|95.0|0.19|0.98||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||0.98|0.19|0.0378
71652424|NCT03827018|142823349|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0651|TWO_SIDED|95.0|0.22|1.06||Calculated by using a log-rank test stratified by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate, and stratified by randomization strata.|Secondary endpoints were analyzed in hierarchical order.||1.06|0.22|0.0651
71704268|NCT03446573|142926326|OTHER||Mean Difference (Net)|4.49|||<|0.001|TWO_SIDED|95.0|3.18|5.81|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.|||5.81|3.18|<0.001
71704269|NCT03446573|142926328|OTHER||Mean Difference (Net)|4.95|||<|0.001|TWO_SIDED|95.0|3.47|6.43|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 96 has been presented.|||6.43|3.47|<0.001
71704270|NCT03446573|142926328|OTHER||Mean Difference (Net)|4.08|||<|0.001|TWO_SIDED|95.0|2.32|5.85|||Mixed Model Repeated Measures||Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 144 has been presented.|||5.85|2.32|<0.001
71704271|NCT03446573|142926329|OTHER||Mean Difference (Net)|-0.0017||||0.741|TWO_SIDED|95.0|-0.0119|0.0085|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0085|-0.0119|0.741
71704272|NCT03446573|142926329|OTHER||Mean Difference (Net)|0.0015||||0.792|TWO_SIDED|95.0|-0.0094|0.0123|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0123|-0.0094|0.792
71704273|NCT03446573|142926330|OTHER||Mean Difference (Net)|0.0003||||0.965|TWO_SIDED|95.0|-0.0121|0.0126|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0126|-0.0121|0.965
71652425|NCT03827018|142823350|OTHER|Descriptive statistic|Least Squares (LS) means difference|-326.45||||0.0667|TWO_SIDED|95.0|-675.99|23.09||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable.|ANCOVA|||||23.09|-675.99|0.0667
71652426|NCT03827018|142823351|OTHER|Descriptive statistic|Difference in percentages|31.0||||0.0201|TWO_SIDED|95.0|11.1|50.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||50.8|11.1|0.0201
71652427|NCT03827018|142823352|OTHER|Descriptive statistic|Difference in percentages|9.5||||0.5533|TWO_SIDED|95.0|-8.7|27.8||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||27.8|-8.7|0.5533
71652428|NCT03827018|142823353|OTHER|Descriptive statistics|Difference in percentages|39.3||||0.0031|TWO_SIDED|95.0|17.2|61.3||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata|Cochran-Mantel-Haenszel|||||61.3|17.2|0.0031
71652429|NCT03827018|142823354|OTHER|Descriptive statistics|Least Squares (LS) means difference|-380.82||||0.1629|TWO_SIDED|95.0|-919.66|158.02||Calculated using ANCOVA with treatment arm and randomization strata as discrete variables, and corticosteroid starting dose as a continuous variable|ANCOVA|||||158.02|-919.66|0.1629
71652430|NCT00350402|142823368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.254|STANDARD_ERROR_OF_MEAN|2.028|<|0.001|TWO_SIDED|95.0|3.147|11.362|||t-test, 2 sided|df = 38; t = 3.576|Treatment effect size: Cohen's D =1.142|Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.||11.362|3.147|< 0.001
71652431|NCT00350402|142823369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.36|STANDARD_ERROR_OF_MEAN|4.955|<|0.459|TWO_SIDED|95.0|-16.41|3.68|||t-test, 2 sided|||Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).||3.68|-16.41|<0.459
71825497|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.72||||0.1431|TWO_SIDED|95.0|-0.24|1.67|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.67|-0.24|0.1431
71886533|NCT05227690|143293398|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
71704274|NCT03446573|142926330|OTHER||Mean Difference (Net)|-0.0109||||0.12|TWO_SIDED|95.0|-0.0247|0.0029|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.|||0.0029|-0.0247|0.120
71704275|NCT03446573|142926331|OTHER||Mean Difference (Net)|-0.1||||0.879|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||1.2|-1.4|0.879
71704276|NCT03446573|142926331|OTHER||Mean Difference (Net)|-0.5||||0.414|TWO_SIDED|95.0|-1.9|0.8|||Mixed Model Repeated Measures||Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.8|-1.9|0.414
71704277|NCT03446573|142926332|OTHER||Mean Difference (Net)|-1.2||||0.102|TWO_SIDED|95.0|-2.5|0.2|||Mixed Model Repeated Measures||Week 96. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.5|0.102
71704278|NCT03446573|142926332|OTHER||Mean Difference (Net)|-1.3||||0.093|TWO_SIDED|95.0|-2.8|0.2|||Mixed Model Repeated Measures||Week 144. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.|||0.2|-2.8|0.093
71704279|NCT02070991|142926334|SUPERIORITY_OR_OTHER||Difference between maci. and placebo|10.08||||0.3372|TWO_SIDED|95.0|-15.07|33.26|||Fisher Exact|||||33.26|-15.07|0.3372
71704280|NCT02070991|142926335|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.77|||||TWO_SIDED|95.0|0.55|1.08||||||||1.08|0.55|
71704281|NCT02070991|142926336|SUPERIORITY_OR_OTHER||Treatment effect (ratio of geom. means)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
71704282|NCT02070991|142926337|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.3|||||TWO_SIDED|95.0|-4.3|4.9||||||||4.9|-4.3|
71704283|NCT02070991|142926338|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.7|||||TWO_SIDED|95.0|-2.2|3.6||||||||3.6|-2.2|
71825498|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0197|TWO_SIDED|95.0|0.18|2.11|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.11|0.18|0.0197
71704284|NCT02070991|142926339|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.3|||||TWO_SIDED|95.0|-4.2|3.7||||||||3.7|-4.2|
71704285|NCT02070991|142926340|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|0.4|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
71704286|NCT02070991|142926341|SUPERIORITY_OR_OTHER||Treatment effect (mean change from BL)|-0.4|||||TWO_SIDED|95.0|-4.5|3.6||||||||3.6|-4.5|
71704287|NCT00827242|142926342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.66||0.004||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.004
71704288|NCT00827242|142926343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.26||0.029||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.029
71704289|NCT00827242|142926344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.057||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.057
71704290|NCT00827242|142926345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS storage subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.002
71704291|NCT00827242|142926346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43||0.02||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS voiding subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.020
71704292|NCT00827242|142926347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.233||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS nocturia question. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.233
71886534|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.1|=|0.3596|TWO_SIDED|95.0|-3.2|1.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||1.2|-3.2|=0.3596
71652432|NCT00350402|142823370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.426|STANDARD_ERROR_OF_MEAN|4.221|<|0.018|TWO_SIDED|95.0|1.874|18.978|||t-test, 2 sided|t-value = 2.47, with 37 df||Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.||18.978|1.874|<0.018
71652433|NCT00350402|142823371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129|STANDARD_ERROR_OF_MEAN|2.492|<|0.047|TWO_SIDED|95.0|0.0834|10.17||No adjustment necessary|t-test, 2 sided|38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = \<0.049, and adjusted df = 27.3||Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).||10.17|.0834|<0.047
71652434|NCT01192399|142823404|OTHER||||||<|0.0001|||||||Sign test|||||||<0.0001
71652435|NCT02443545|142823420|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.0000
71652436|NCT02443545|142823420|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0000
71652437|NCT02443545|142823420|OTHER|One-sample t-test, to determine whether the change from baseline in LIC was significantly different from 0.||||||0|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0000
71652438|NCT02443545|142823421|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.3146|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.3146
71652439|NCT02443545|142823421|OTHER|One-sample t-test, to determine whether the change from baseline in MRI T2\* was significantly different from 0.||||||0.9454|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.9454
71652440|NCT02443545|142823421|OTHER|One-sample t-test, to determine whether the change from baseline in MRI 2\* was significantly different from 0.||||||0.4336|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.4336
71652441|NCT02443545|142823422|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.9952|||||||t-test, 2 sided|||Change from baseline after 1 year of deferiprone therapy||||0.9952
71652442|NCT02443545|142823422|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.0008|||||||t-test, 2 sided|||Change from baseline after 2 years of deferiprone therapy||||0.0008
71763227|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|0.26|0.46|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM|||0.46|0.26|
71652443|NCT02443545|142823422|OTHER|One-sample t-test, to determine whether the change from baseline in serum ferritin was significantly different from 0||||||0.042|||||||t-test, 2 sided|||Change from baseline after 3 years of deferiprone therapy||||0.0420
71652444|NCT00536484|142823423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.4||Significance level p \<0.05|ANCOVA|Terms for treatment, center and baseline as covariate and baseline by treatment interaction.|The LS mean difference \& 95% CI were calculated at mean baseline = 12.9 (centered baseline used in model)|Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine \& placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm||-0.4|-1.1|0.0002
71652445|NCT00536484|142823424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0136||95.0|-0.8|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment, baseline covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||-0.1|-0.8|0.0136
71652446|NCT00536484|142823424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002||95.0|-1.1|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.3|-1.1|0.0002
71652447|NCT00536484|142823425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1057||95.0|-0.9|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.9|0.1057
71652448|NCT00536484|142823425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0338||95.0|-1.1|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.0|-1.1|0.0338
71652449|NCT00536484|142823425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0003||95.0|-1.5|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.5|-1.5|0.0003
71652450|NCT00536484|142823426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1666||95.0|-0.6|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||0.1|-0.6|0.1666
71652451|NCT00536484|142823426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0506||95.0|-0.8|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||0.0|-0.8|0.0506
71652452|NCT00536484|142823426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0014||95.0|-1.0|-0.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.2|-1.0|0.0014
71763228|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM|||0.36|0.16|
71763229|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.34|||||TWO_SIDED|95.0|0.24|0.44|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM|||0.44|0.24|
71763230|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM|||0.34|0.14|
71763231|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM|||0.36|0.16|
71825499|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|-0.05||||0.9223|TWO_SIDED|95.0|-1.03|0.93|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.93|-1.03|0.9223
71825500|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.14||||0.0237|TWO_SIDED|95.0|0.15|2.13|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.13|0.15|0.0237
71825501|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.4523|TWO_SIDED|95.0|-0.53|1.19|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.19|-0.53|0.4523
71652453|NCT00536484|142823427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.2054||95.0|-0.4|0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline||0.1|-0.4|0.2054
71652454|NCT00536484|142823427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0225||95.0|-0.6|0.0||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline||-0.0|-0.6|0.0225
71652455|NCT00536484|142823427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0167||95.0|-0.6|-0.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-0.1|-0.6|0.0167
71652456|NCT00536484|142823428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8019||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8019
71652457|NCT00536484|142823428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3881||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.3881
71652458|NCT00536484|142823428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.324||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.1|-0.2|0.3240
71652459|NCT00536484|142823429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8279||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 2 minus Baseline||0.1|-0.2|0.8279
71704293|NCT00827242|142926348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.013||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS QoL Index. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.013
71704294|NCT00827242|142926349|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.021
71704295|NCT00827242|142926350|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate \[total IPSS \< 20\]; severe \[total IPSS \>= 20\]||||||0.009
71704296|NCT00827242|142926351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.146||95.0||||The p-value associates with LS Mean difference of changes from baseline to 1 week between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.146
71704297|NCT00827242|142926352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||0.003
71704298|NCT00827242|142926353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IIEF-EF domain score. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA|||||||<0.001
71704299|NCT00827242|142926354|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for Qmax. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.300
71704300|NCT00827242|142926357|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for PVR volume. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA|||||||0.500
71704301|NCT05987540|142926366|SUPERIORITY|||||||0.8125|||||||Wilcoxon matched-pairs signed rank|||||||.8125
71704302|NCT05987540|142926369|SUPERIORITY||||||>|0.9999|||||||Wilconxon matched-pairs signed rank test|||||||>0.9999
71704303|NCT00471107|142926370|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Power analysis was based on WMS-III Word Lists performance. With an effect comparable to the effect on verbal fluency in an earlier study of left frontal TDCS in healthy subjects, it would require 10 subjects per group (30 total) for a significance level of 0.05 and 80% power.||||>0.05
71704304|NCT00888849|142926410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|7.69||0.7774|TWO_SIDED|95.0|-19.4|10.9||Adjusted for multiplicity via the Bonferroni-Holm method|ANOVA|||||10.9|-19.4|0.7774
71704305|NCT00888849|142926411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.8||0.0008|TWO_SIDED|95.0|1.4|4.5||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||4.5|1.4|0.0008
71704306|NCT00888849|142926412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.7774|TWO_SIDED|95.0|-0.2|0.6||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA|||||0.6|-0.2|0.7774
71704307|NCT02508207|142926413|OTHER|||||||0.7151||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.7151
71704308|NCT02508207|142926414|OTHER|||||||0.0004||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0004
71704309|NCT02508207|142926415|OTHER|||||||0.3345|||||||t-test, 2 sided|p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.||||||0.3345
71763232|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.18|||||TWO_SIDED|95.0|0.08|0.28|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM|||0.28|0.08|
71704310|NCT02508207|142926416|OTHER|||||||0.0002||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided|||||||0.0002
71704311|NCT00514917|142926432|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0501|TWO_SIDED|95.0|1.0|1.65||A priori threshold for statistical significance = 0.05|Log Rank|P-value was not adjusted for multiplicity of tests.|The hazard ratio Leuprolide+Bicalutamide vs. Docetaxel+Leuprolide+Bicalutamide was estimated using an un-stratified Cox proportional hazards model. A hazard ratio \>1 indicates a lower risk of Docetaxel+Leuprolide, compared to Leuprolide.|"Null hypothesis: No difference between new treatment combination (Docetaxel+Leuprolide+Bicalutamide) and conventional treatment (Leuprolide+Bicalutamide).~The study was sized to have 90% power to detect a difference between treatment arms at a 2-sided 0.05 significance level with 186 events and anticipating 10% non-evaluable participants."||1.65|1.00|0.0501
71704312|NCT02697422|142926443|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704313|NCT02697422|142926444|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704314|NCT02697422|142926445|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704315|NCT02697422|142926446|SUPERIORITY|||||||0.9|TWO_SIDED|95.0||||Smoker/tobacco use results were calculated using logistic regression.|Regression, Logistic|||Smoker/tobacco use results were calculated using logistic regression. A P value of .90 was found comparing smoking/tobacco use in intervention vs control participants. A difference was not reported between intervention and control because smoking/ tobacco use was a binary variable.||||0.90
71704316|NCT02697422|142926447|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704317|NCT02697422|142926448|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704318|NCT02697422|142926449|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704319|NCT02697422|142926450|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704320|NCT02697422|142926451|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704321|NCT02697422|142926452|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||||||0.05
71704322|NCT01659541|142926454|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons was made at various points in the study (Week #28, #40 and #52).||||<0.05
71704323|NCT01659541|142926455|OTHER|Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control (Pre-Implant); comparisons were made at various points in the study (Week #28, #40 and #52).||||<0.05
71704324|NCT01659541|142926456|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant)) were compared with data obtained after implantation (Week ##28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
71704325|NCT01659541|142926457|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
71704326|NCT01659541|142926458|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28 ,#40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. Paired t test. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
71704327|NCT01659541|142926459|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation (Pre-Implant) were compared with data obtained after implantation (Week #28, #40, #52) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± Standard Error.||||<0.05
71763233|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM|||0.34|0.14|
71763234|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|0.07|0.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM|||0.27|0.07|
71763235|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.03|0.17|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM|||0.17|-0.03|
71763236|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.06|0.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM|||0.14|-0.06|
71763237|NCT02712047|143028225|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.07|0.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM|||0.13|-0.07|
71763238|NCT03036215|143028230|OTHER||Mean Difference (Net)|-7.0|||||TWO_SIDED|||||||||Pilot study, no power analysis applicable; no statistical test||||
71825502|NCT01720446|143155309|SUPERIORITY_OR_OTHER||Treatment difference|1.2||||0.0064|TWO_SIDED|95.0|0.34|2.07|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.07|0.34|0.0064
71652460|NCT00536484|142823429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5059||95.0|-0.2|0.1||Significance level p \<0.05|ANOVA|||Week 6 minus Baseline||0.1|-0.2|0.5059
71652461|NCT00536484|142823429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0806||95.0|-0.4|0.0||Significance level p \<0.05|ANOVA|||Week 12 minus Baseline||0.0|-0.4|0.0806
71652462|NCT00536484|142823430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0203||95.0|-3.2|-0.3||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.3|-3.2|0.0203
71652463|NCT00536484|142823430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.8||0.0007||95.0|-4.2|-1.1||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-1.1|-4.2|0.0007
71652464|NCT00536484|142823430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-4.9|-1.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-1.7|-4.9|<0.0001
71652465|NCT00536484|142823431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001||95.0|-10.7|-4.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline||-4.9|-10.7|<0.0001
71652466|NCT00536484|142823432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|5.3|11.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Concern domain"||11.5|5.3|<0.0001
71763239|NCT03036215|143028231|OTHER|pilot study; no statistical test performed|Mean Difference (Net)|1.0|||||TWO_SIDED|||||||||Pilot study; no statistical test run||||
71825503|NCT01720446|143155310|SUPERIORITY_OR_OTHER||Treatment ratio|0.99||||0.7796|TWO_SIDED|95.0|0.95|1.04|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||1.04|0.95|0.7796
71825504|NCT01720446|143155310|SUPERIORITY_OR_OTHER||Treatment ratio|0.92||||0.0003|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||0.96|0.88|0.0003
71652467|NCT00536484|142823432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001||95.0|3.9|10.2||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Coping domain"||10.2|3.9|<0.0001
71652468|NCT00536484|142823432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.6||0.0036||95.0|1.5|7.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate||"Week 12 minus Baseline~Sleep domain"||7.8|1.5|0.0036
71652469|NCT00536484|142823432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0007||95.0|1.6|5.8||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Social interaction domain"||5.8|1.6|0.0007
71652470|NCT00536484|142823432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001||95.0|3.6|8.9||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~HRQL scale score total"||8.9|3.6|<0.0001
71652471|NCT00536484|142823433|SUPERIORITY_OR_OTHER|||||||0.0087||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0087
71652472|NCT00536484|142823433|SUPERIORITY_OR_OTHER|||||||0.0008||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0008
71652473|NCT00536484|142823433|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0006
71652474|NCT00536484|142823434|SUPERIORITY_OR_OTHER|||||||0.0129||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2||||0.0129
71652475|NCT00536484|142823434|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6||||0.0100
71652476|NCT00536484|142823434|SUPERIORITY_OR_OTHER|||||||0.0009||95.0||||Significance level p \<0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12||||0.0009
71652477|NCT00536484|142823435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.4||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline||-0.4|-0.9|<0.0001
71652478|NCT00536484|142823435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.5||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline||-0.5|-1.1|<0.0001
71763240|NCT03036215|143028232|OTHER||Mean Difference (Net)|-5.2|||||TWO_SIDED|||||||||Pilot study; no statistical test for significance run||||
71652479|NCT00536484|142823435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.3|-0.7||Significance level p \<0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline||-0.7|-1.3|<0.0001
71652480|NCT01506908|142823436|SUPERIORITY_OR_OTHER||Least squares means difference|-15.9|||<|0.0001|TWO_SIDED|95.0|-21.6|-10.2|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes||-10.2|-21.6|<0.0001
71652481|NCT01506908|142823437|SUPERIORITY_OR_OTHER||Least squares means difference|-4.2||||0.0511|TWO_SIDED|95.0|-8.4|0.0|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.||0.0|-8.4|0.0511
71652482|NCT01506908|142823438|SUPERIORITY_OR_OTHER||Least squares means difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.7|-6.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.||-6.4|-16.7|<0.0001
71652483|NCT01506908|142823439|SUPERIORITY_OR_OTHER||Least squares means difference|-17.8|||<|0.0001|TWO_SIDED|95.0|-23.8|-11.7|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.||-11.7|-23.8|<0.0001
71652484|NCT01506908|142823440|SUPERIORITY_OR_OTHER||Least square mean difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-24.4|-11.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population's change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.||-11.4|-24.4|<0.0001
71652485|NCT00440115|142823461|SUPERIORITY|Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.12||||0.54|TWO_SIDED|95.0|0.78|1.61|||Mixed Models Analysis||(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management|||1.61|0.78|0.54
71652486|NCT00440115|142823461|SUPERIORITY|Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.33||||0.18|TWO_SIDED|95.0|0.88|2.02|||Mixed Models Analysis||High-intensity disease management vs moderate-intensity disease management|||2.02|0.88|0.18
71652487|NCT02953678|142823481|OTHER||Exact method for binomial distributions|54.9|||||TWO_SIDED|95.0|42.7|66.8||||||||66.8|42.7|
71704328|NCT01222351|142926460|EQUIVALENCE|The null hypothesis was that there is no difference in the rate of cognitive decline between participants with and without amyloid.|Slope|-0.034||||0.02|TWO_SIDED||||||latent growth curve model|Latent growth curve models tested cognitive decline rate by amyloid status.|B weights were the estimates for the association between Aβ and cognitive change.|||||0.02
71704329|NCT03055507|142926466|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.05|TWO_SIDED|96.0|-2.4|0.5|||t-test, 1 sided|||||0.5|-2.4|<0.05
71704330|NCT02068599|142926480|SUPERIORITY||LSM difference from placebo|4.26||||0.1213|TWO_SIDED|95.0|-1.13|9.66||5% level of significance|mixed model for repeated measures|||LSM = least square mean||9.66|-1.13|0.1213
71704331|NCT02068599|142926480|SUPERIORITY||LSM difference from placebo|1.74||||0.5231|TWO_SIDED|95.0|-3.62|7.11||5% level of significance|mixed model for repeated measures|||LSM = least square mean||7.11|-3.62|0.5231
71774899|NCT00537238|143050063|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.432||||0.0696|TWO_SIDED|95.0|0.972|2.11|||Regression, Logistic|||Week 16: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||2.110|0.972|0.0696
71652488|NCT00784134|142823499|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.027||||0.554|TWO_SIDED|95.0|-0.062|0.115|||Chi-squared|||||0.115|-0.062|0.554
71652489|NCT00784134|142823499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.465|TWO_SIDED|95.0|0.75|1.87||Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.|Multivariable Logit Model|||||1.87|0.75|0.465
71652490|NCT00784134|142823500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.484|TWO_SIDED|95.0|0.63|1.25||Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score \> K v. \<= K for K = 1 - 4; Alt v. Sal.|Generalized ordered Logit Model|||||1.25|0.63|0.484
71652491|NCT00784134|142823500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.71||The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).|Generalized ordered Logit Model|||||0.71|0.28|<0.001
71652492|NCT00784134|142823501|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.026||||0.552|TWO_SIDED|95.0|-0.059|0.111|||Chi-squared|||||0.111|-0.059|0.552
71652493|NCT00784134|142823501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.35|TWO_SIDED|95.0|0.8|1.9||Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Multivariable Logit Model|||||1.90|0.80|0.350
71774900|NCT01051466|143050111|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||The significance level was 0.05 for a 2-sided test.|Mixed Models Analysis|||||||0.457
71774901|NCT01051466|143050112|SUPERIORITY_OR_OTHER|||||||0.627||||||The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.|Mixed Models Analysis|||||||0.627
71774902|NCT01051466|143050112|SUPERIORITY_OR_OTHER|||||||0.338||||||The p-value is for change from baseline activation (BOLD response) in the left amygdala.|Mixed Models Analysis|||||||0.338
71704332|NCT02068599|142926481|SUPERIORITY||LSM difference from placebo|17.86||||0.1795|TWO_SIDED|95.0|-8.26|43.98||5% level of significance|mixed model for repeated measures|||LSM = least square mean||43.98|-8.26|0.1795
71825505|NCT01720446|143155311|SUPERIORITY_OR_OTHER||Treatment difference|2.02|||<|0.0001|TWO_SIDED|95.0|1.07|2.98|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||2.98|1.07|<0.0001
71652494|NCT00784134|142823502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.428|TWO_SIDED|95.0|0.78|1.8||Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Random Effects Model|||||1.80|0.78|0.428
71652495|NCT00784134|142823503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.384|TWO_SIDED|95.0|0.75|2.1|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 30 days||2.10|0.75|0.384
71652496|NCT00784134|142823503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.964|TWO_SIDED|95.0|0.62|1.64|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 180 days||1.64|0.62|0.964
71652497|NCT00784134|142823504|SUPERIORITY_OR_OTHER|||||||0.0056|||||||Log Rank|||||||0.0056
71652498|NCT00784134|142823505|SUPERIORITY_OR_OTHER||||||<|0.001|||||||AUC/ Logit Model|||||||<0.001
71652499|NCT00784134|142823506|SUPERIORITY_OR_OTHER|||||||0.771|||||||Kruskal-Wallis|||||||0.771
71652500|NCT00784134|142823507|SUPERIORITY_OR_OTHER|||||||0.098|||||||Kruskal-Wallis|||||||0.098
71652501|NCT00784134|142823508|SUPERIORITY_OR_OTHER|||||||0.45|||||||Generalized Linear Models|||||||0.450
71652502|NCT00784134|142823509|SUPERIORITY_OR_OTHER|||||||0.501|||||||Chi-squared|||||||0.501
71652503|NCT00784134|142823510|SUPERIORITY_OR_OTHER|||||||0.795|||||||Chi-squared|||||||0.795
71652504|NCT00784134|142823511|SUPERIORITY_OR_OTHER|||||||0.784|||||||Chi-squared|||||||0.784
71652505|NCT00784134|142823512|SUPERIORITY_OR_OTHER|||||||0.592|||||||Chi-squared|||||||0.592
71704333|NCT02068599|142926481|SUPERIORITY||LSM difference from placebo|9.0||||0.4956|TWO_SIDED|95.0|-16.95|34.96||5% level of significance|mixed model for repeated measures|||LSM = least square mean||34.96|-16.95|0.4956
71704334|NCT02068599|142926482|SUPERIORITY||LSM difference from placebo|3.61||||0.1963|TWO_SIDED|95.0|-1.87|9.08||5% level of significance|mixed model for repeated measures|||||9.08|-1.87|0.1963
71652506|NCT00784134|142823513|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared|||||||0.105
71652507|NCT00784134|142823514|SUPERIORITY_OR_OTHER|||||||0.152|||||||Chi-squared|||||||0.152
71652508|NCT00784134|142823515|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.055||||0.055|TWO_SIDED|95.0|-0.111|0.008|||Fisher Exact|||||0.008|-0.111|0.055
71652509|NCT00784134|142823516|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.035||||0.202|TWO_SIDED|95.0|-0.084|0.014|||Fisher Exact|||||0.014|-0.084|0.202
71652510|NCT00784134|142823517|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.771|TWO_SIDED|95.0|-0.022|0.03|||Fisher Exact|||||0.030|-0.022|0.771
71652511|NCT00784134|142823518|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||0.811|TWO_SIDED|95.0|-0.028|0.036|||Fisher Exact|||||0.036|-0.028|0.811
71652512|NCT00784134|142823519|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.144||||0.0017|TWO_SIDED|95.0|-0.23|-0.057|||Fisher Exact|||||-0.057|-0.230|0.0017
71652513|NCT00784134|142823520|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.006|TWO_SIDED|95.0|0.41|0.86|||Cox Proportional Hazards Model|Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||||0.86|0.41|0.006
71652514|NCT00784134|142823521|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.064||||0.41|TWO_SIDED|95.0|-0.088|0.217|||Chi-squared|||||0.217|-0.088|0.410
71652515|NCT00784134|142823522|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.016||||0.781|TWO_SIDED|95.0|-0.096|0.128|||Chi-squared|||||0.128|-0.096|0.781
71652516|NCT00784134|142823523|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.773|TWO_SIDED|95.0|-0.113|0.152|||Chi-squared|||||0.152|-0.113|0.773
71652517|NCT00784134|142823524|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.032||||0.587|TWO_SIDED|95.0|-0.085|0.151|||Chi-squared|||||0.151|-0.085|0.587
71652518|NCT00784134|142823525|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.015||||0.775|TWO_SIDED|95.0|-0.09|0.121|||Chi-squared|||||0.121|-0.09|0.775
71652519|NCT00784134|142823526|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.019||||0.808|TWO_SIDED|95.0|-0.132|0.169|||Chi-squared|||||0.169|-0.132|0.808
71652520|NCT00784134|142823527|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.033||||0.625|TWO_SIDED|95.0|-0.165|0.099|||Chi-squared|||||0.099|-0.165|0.625
71652521|NCT00784134|142823528|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.087||||0.191|TWO_SIDED|95.0|-0.043|0.218|||Chi-squared|||||0.218|-0.043|0.191
71652522|NCT00784134|142823529|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0066||||0.949|TWO_SIDED|95.0|-0.197|0.211|||Chi-squared|||||0.211|-0.197|0.949
71652523|NCT00784134|142823530|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.014||||0.812|TWO_SIDED|95.0|-0.098|0.126|||Chi-squared|||||0.126|-0.098|0.812
71652524|NCT00784134|142823531|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.059||||0.394|TWO_SIDED|95.0|-0.076|0.194|||Chi-squared|||||0.194|-0.076|0.394
71652525|NCT00784134|142823532|SUPERIORITY_OR_OTHER|||||||0.312|||||||Wilcoxon (Mann-Whitney)|||||||0.312
71652526|NCT00784134|142823533|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.075||||0.087|TWO_SIDED|95.0|-0.011|0.16||Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores|Chi-squared|||||0.160|-0.011|0.087
71652527|NCT00784134|142823533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.064|TWO_SIDED|95.0|0.98|2.43||Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline|Multivariable Logit Model|||||2.43|0.98|0.064
71652528|NCT00784134|142823533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.336|TWO_SIDED|95.0|0.7|2.89||Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||2.89|0.70|0.336
71652529|NCT00784134|142823533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.783|TWO_SIDED|95.0|0.57|1.52||Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model|||||1.52|0.57|0.783
71652530|NCT00784134|142823534|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71652531|NCT00784134|142823535|SUPERIORITY_OR_OTHER|||||||0.312|||||||t-test, 2 sided|||||||0.312
71652532|NCT00784134|142823536|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71652533|NCT00784134|142823537|SUPERIORITY_OR_OTHER|||||||0.478|||||||t-test, 2 sided|||||||0.478
71652534|NCT00784134|142823538|SUPERIORITY_OR_OTHER|||||||0.634|||||||t-test, 2 sided|||||||0.634
71652535|NCT00784134|142823539|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|||||||0.255
71652536|NCT00784134|142823540|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
71652537|NCT00784134|142823541|SUPERIORITY_OR_OTHER|||||||0.882|||||||t-test, 2 sided|||||||0.882
71652538|NCT00784134|142823542|SUPERIORITY_OR_OTHER|||||||0.551|||||||t-test, 2 sided|||||||0.551
71652539|NCT00784134|142823543|SUPERIORITY_OR_OTHER|||||||0.224|||||||t-test, 2 sided|||||||0.224
71652540|NCT00784134|142823544|SUPERIORITY_OR_OTHER|||||||0.376|||||||t-test, 2 sided|||||||0.376
71652541|NCT03686150|142823563|OTHER|This was a population PK analysis of 25(OH)D after oral administration of Vitamin D.||||||||||||||||Part 1 of this study was to perform a population PK analysis of 25(OH)D after oral administration of Vitamin D in children who are overweight or obese and have asthma. Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|Based on the interim analysis of the VDORA study, the PK of 25(OH)D after Vitamin D supplementation in children was well characterized by a 2-compartment population PK model with linear absorption and elimination kinetics. A loading dose of 50,000 IU followed by a daily dose of 8,000 IU was recommended.|||
71652542|NCT03686150|142823564|OTHER|This is one-sample test of proportion testing the null hypothesis that the proportion of participants with 25(OH)D level \>= 40 ng/mL is 50%.||||||0.0001|||||||z-test|||This is a one-sample test of proportion.||||0.0001
71652543|NCT03694808|142823565|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|ratio of GMT (Fluzone/Fluad)|1.23|||||TWO_SIDED|95.0|0.8|1.89|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||1.89|0.8|
71652544|NCT03694808|142823565|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.95|||||TWO_SIDED|95.0|0.66|1.38|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.38|0.66|
71652545|NCT03694808|142823566|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.38|||||TWO_SIDED|95.0|0.88|2.15|||t-test, 2 sided|||Statistical Analysis for Year 1 (2018-2019)||2.15|0.88|
71652546|NCT03694808|142823566|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.86|||||TWO_SIDED|95.0|0.53|1.4|||t-test, 2 sided|||Statistical Analysis for Year 2 (2019-2020)||1.4|0.53|
71652547|NCT03694808|142823567|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|1.85|||||TWO_SIDED|95.0|1.23|2.79|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||2.79|1.23|
71704335|NCT02068599|142926482|SUPERIORITY||LSM difference from placebo|2.06||||0.4584|TWO_SIDED|95.0|-3.39|7.5||5% level of significance|mixed model for repeated measures|||||7.50|-3.39|0.4584
71704336|NCT02068599|142926483|SUPERIORITY||LSM difference from placebo|23.51||||0.642|TWO_SIDED|95.0|-75.83|122.84||5% level of significance|mixed model for repeated measures|||||122.84|-75.83|0.6420
71704337|NCT02068599|142926483|SUPERIORITY||LSM difference from placebo|-50.4||||0.3141|TWO_SIDED|95.0|-148.72|47.92||5% level of significance|mixed model for repeated measures|||||47.92|-148.72|0.3141
71704338|NCT02068599|142926484|SUPERIORITY||LSM difference from placebo|3.16||||0.6184|TWO_SIDED|95.0|-9.31|15.63||5% level of significance|mixed model for repeated measures|||||15.63|-9.31|0.6184
71652548|NCT03694808|142823567|NON_INFERIORITY|2-sided t-test performed on log-transformed titers; estimate and 95% confidence interval of log-scale difference exponentiated to generate GMT ratio and its 95% CI below.|Ratio of GMT (Fluzone/Fluad)|0.88|||||TWO_SIDED|95.0|0.61|1.26|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.26|0.61|
71704339|NCT02068599|142926484|SUPERIORITY||LSM difference from placebo|-3.48||||0.5775|TWO_SIDED|95.0|-15.78|8.81||5% level of significance|mixed model for repeated measures|||||8.81|-15.78|0.5775
71704340|NCT02068599|142926485|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1011|TWO_SIDED|95.0|0.345|1.099||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.099|0.345|0.1011
71704341|NCT02068599|142926485|SUPERIORITY||Odds Ratio (OR)|1.06||||0.84|TWO_SIDED|95.0|0.615|1.819||5% level of significance|mixed model for repeated measures|||\>=50% responder rate||1.819|0.615|0.8400
71652549|NCT03694808|142823568|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.154|||||TWO_SIDED|95.0|-0.001|0.308|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.308|-0.001|
71652550|NCT03694808|142823568|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.056|||||TWO_SIDED|95.0|-0.2|0.089|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.089|-0.2|
71652551|NCT03694808|142823569|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.218|||||TWO_SIDED|95.0|0.063|0.373|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.373|0.063|
71652552|NCT03694808|142823569|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.008|||||TWO_SIDED|95.0|-0.139|0.123|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.123|-0.139|
71652553|NCT03694808|142823570|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.136|||||TWO_SIDED|95.0|-0.019|0.291|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.291|-0.019|
71652554|NCT03694808|142823570|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|0.024|||||TWO_SIDED|95.0|-0.117|0.164|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.164|-0.117|
71652555|NCT03694808|142823571|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.43|||||TWO_SIDED|95.0|0.29|0.64|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||0.64|0.29|
71652556|NCT03694808|142823571|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||0.69|0.29|
71652557|NCT03694808|142823572|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.91|||||TWO_SIDED|95.0|0.71|1.16|||t-test, 2 sided|||Statistical Analysis Year 1 (2018-2019)||1.16|0.71|
71652558|NCT03694808|142823572|NON_INFERIORITY|Ratio of GMT (Fluzone/Fluad), upper bound of two-sided 95% CI should not exceed 1.5 for non-inferiority|Ratio of GMT (Fluzone/Fluad)|0.96|||||TWO_SIDED|95.0|0.69|1.33|||t-test, 2 sided|||Statistical Analysis Year 2 (2019-2020)||1.33|0.69|
71652559|NCT03694808|142823573|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.544|||||TWO_SIDED|95.0|-0.674|-0.414|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||-0.414|-0.674|
71652560|NCT03694808|142823573|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.168|||||TWO_SIDED|95.0|-0.311|-0.025|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||-0.025|-0.311|
71652561|NCT03694808|142823574|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference in proportions|-0.104|||||TWO_SIDED|95.0|-0.221|0.013|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 1 (2018-2019)||0.013|-0.221|
71652562|NCT03694808|142823574|NON_INFERIORITY|Difference between seroconversion rates (Fluzone - Fluad), upper bound of two-sided 95% CI of difference should not exceed 10 percentage points for non-inferiority|Difference of proportions|-0.113|||||TWO_SIDED|95.0|-0.241|0.015|||Test of proportions|2sided proportions test to estimate 95% CI difference in seroconversion rates; upper limit differences compared to 10%, per non-inferiority guidance||Statistical Analysis Year 2 (2019-2020)||0.015|-0.241|
71652563|NCT03660241|142823588|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|138.49|||||TWO_SIDED|90.0|93.74|204.61|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group.||204.61|93.74|
71652564|NCT03660241|142823588|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.11|||||TWO_SIDED|90.0|57.3|171.43|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||171.43|57.30|
71652565|NCT03660241|142823589|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|182.91|||||TWO_SIDED|90.0|117.09|285.71|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.71|117.09|
71652566|NCT03660241|142823589|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|121.32|||||TWO_SIDED|90.0|68.32|215.41|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||215.41|68.32|
71652567|NCT03660241|142823590|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|99.51|||||TWO_SIDED|90.0|59.8|165.57|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||165.57|59.80|
71652568|NCT03660241|142823590|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|167.79|||||TWO_SIDED|90.0|97.2|289.64|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||289.64|97.20|
71652569|NCT03660241|142823591|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|154.22|||||TWO_SIDED|90.0|105.11|226.26|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||226.26|105.11|
71652570|NCT03660241|142823591|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|287.06|||||TWO_SIDED|90.0|196.72|418.89|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||418.89|196.72|
71652571|NCT03660241|142823592|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|137.43|||||TWO_SIDED|90.0|106.82|176.81|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||176.81|106.82|
71652572|NCT03660241|142823592|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|177.92|||||TWO_SIDED|90.0|135.91|232.92|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||232.92|135.91|
71704342|NCT02068599|142926485|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6607|TWO_SIDED|95.0|0.531|1.494||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.494|0.531|0.6607
71704343|NCT02068599|142926485|SUPERIORITY||Odds Ratio (OR)|0.87||||0.5777|TWO_SIDED|95.0|0.52|1.441||5% level of significance|mixed model for repeated measures|||\>=30% responder rate||1.441|0.520|0.5777
71704344|NCT02068599|142926486|SUPERIORITY||LSM difference from placebo|3.94||||0.4316|TWO_SIDED|95.0|-5.9|13.79||5% level of significance|mixed model for repeated measures|||||13.79|-5.90|0.4316
71704345|NCT02068599|142926486|SUPERIORITY||LSM difference from placebo|2.51||||0.6126|TWO_SIDED|95.0|-7.24|12.26||5% level of significance|mixed model for repeated measures|||||12.26|-7.24|0.6126
71704346|NCT02068599|142926487|SUPERIORITY||LSM difference from placebo|0.01||||0.9208|TWO_SIDED|95.0|-0.232|0.257||5% level of significance|mixed model for repeated measures|||Week 2||0.257|-0.232|0.9208
71704347|NCT02068599|142926487|SUPERIORITY||LSM difference from placebo|0.04||||0.7344|TWO_SIDED|95.0|-0.2|0.284||5% level of significance|mixed model for repeated measures|||Week 2||0.284|-0.200|0.7344
71704348|NCT02068599|142926487|SUPERIORITY||LSM difference from placebo|0.21||||0.1199|TWO_SIDED|95.0|-0.056|0.486||5% level of significance|mixed model for repeated measures|||Week 4||0.486|-0.056|0.1199
71704349|NCT02068599|142926487|SUPERIORITY||LSM difference from placebo|0.06||||0.6357|TWO_SIDED|95.0|-0.204|0.334||5% level of significance|mixed model for repeated measures|||Week 4||0.334|-0.204|0.6357
71704350|NCT02068599|142926488|SUPERIORITY||LSM difference from placebo|2.77||||0.2906|TWO_SIDED|95.0|-2.377|7.916||5% level of significance|mixed model for repeated measures|||Week 2||7.916|-2.377|0.2906
71704351|NCT02068599|142926488|SUPERIORITY||LSM difference from placebo|1.41||||0.5892|TWO_SIDED|95.0|-3.707|6.518||5% level of significance|mixed model for repeated measures|||Week 2||6.518|-3.707|0.5892
71704352|NCT02068599|142926488|SUPERIORITY||LSM difference from placebo|0.82||||0.7699|TWO_SIDED|95.0|-4.678|6.315||5% level of significance|mixed model for repeated measures|||Week 4||6.315|-4.678|0.7699
71763241|NCT01303224|143028248|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted by using the Hochberg Procedure.|Mantel Haenszel|||Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.||||<0.05
71763242|NCT01303224|143028249|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Multiplicity was adjusted using the Hochberg procedure.|Mantel Haenszel|||||||<0.05
71704353|NCT02068599|142926488|SUPERIORITY||LSM difference from placebo|1.74||||0.532|TWO_SIDED|95.0|-3.721|7.193||5% level of significance|mixed model for repeated measures|||Week 4||7.193|-3.721|0.5320
71704354|NCT02068599|142926489|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5358|TWO_SIDED|95.0|0.501|1.433||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||1.433|0.501|0.5358
71704355|NCT02068599|142926489|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1532|TWO_SIDED|95.0|0.87|2.423||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment\*week as explanatory factors. The unstructured working correlation structure was applied.||2.423|0.870|0.1532
71704356|NCT00309244|142926522|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 25% drop-out rate, 677 subjects were randomized.|Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|
71704357|NCT00309244|142926523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.41||0.0002|TWO_SIDED|95.0|-2.4|-0.7|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-0.7|-2.4|0.0002
71704358|NCT00309244|142926524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_ERROR_OF_MEAN|5.9||0.0029|TWO_SIDED|95.0|-29.3|-6.1|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline fasting plasma glucose as covariate||-6.1|-29.3|0.0029
71704359|NCT00309244|142926525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.2793|TWO_SIDED|95.0|0.486|1.231|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.231|0.486|0.2793
71704360|NCT00309244|142926526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.423|||<|0.001|TWO_SIDED|95.0|0.307|0.581|||Regression, Logistic||Model: Treatment + Site|||0.581|0.307|<0.001
71704361|NCT00309244|142926527|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.409||||0.0066|TWO_SIDED|95.0|0.215|0.78|||Regression, Logistic||Model: Treatment + Site|||0.780|0.215|0.0066
71704362|NCT00309244|142926528|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Generalized Estimation Equation|Based on Poisson distribution||||||0.0027
71704363|NCT00309244|142926529|SUPERIORITY_OR_OTHER|||||||0.0591|||||||Generalized Estimating Equation|Based on Poission distribution||||||0.0591
71704364|NCT03019588|142926551|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.29|TWO_SIDED|95.0|0.58|1.36|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||1.36|0.58|0.2900
71763243|NCT00843284|143028261|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.16|STANDARD_DEVIATION|2.52|<|0.0001||95.0|-4.35|-3.97|||t-test, 2 sided|One sample t-test||Change from Baseline; observational study||-3.97|-4.35|<0.0001
71763244|NCT00843284|143028262|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.02|STANDARD_DEVIATION|2.9|<|0.0001||95.0|-4.24|-3.8|||t-test, 2 sided|One sample t-test.||Change from baseline||-3.80|-4.24|<0.0001
71763245|NCT00147069|143028265|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71825506|NCT01720446|143155311|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.0001|TWO_SIDED|95.0|1.52|3.43|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.||3.43|1.52|<0.0001
71825507|NCT01020838|143155313|SUPERIORITY_OR_OTHER||Sensitivity|0.774|||||TWO_SIDED|95.0|0.654|0.894|||||Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.~The following hypothesis was formulated for sensitivity:~H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity \> 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6"||0.894|0.654|
71825508|NCT01020838|143155313|SUPERIORITY_OR_OTHER||Specificity|0.942|||||TWO_SIDED|95.0|0.886|0.998|||||Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.~The following hypothesis was formulated for specificity:~H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity \> 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8"||0.998|0.886|
71825509|NCT01167426|143155320|SUPERIORITY_OR_OTHER||Difference in mean ranks|79.6|||<|0.0001||95.0|||||Wilcoxon Signed-Rank||Difference in mean ranks between Week 2 and Week 6|Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).||||<0.0001
71763246|NCT00147069|143028266|SUPERIORITY|||||||0.05||||||The reported p value was calculated|Kruskal-Wallis|||||||0.05
71825510|NCT01167426|143155321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.|Chi-squared|||||||<0.0001
71763247|NCT00147069|143028267|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
71704365|NCT03019588|142926552|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.9954|TWO_SIDED|95.0|1.14|2.74|||Log Rank|One-sided p-value based on log-rank test stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||2.74|1.14|0.9954
71704366|NCT03019588|142926553|SUPERIORITY||Difference in percentage|-6.0||||0.7884|TWO_SIDED|95.0|-21.6|9.3|||Z-test|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by time to progression on first line therapy (\< 6 months vs. ≥ 6 months) and ECOG PS (0 vs. 1).|||9.3|-21.6|0.7884
71704367|NCT00106535|142926562|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71704368|NCT00106535|142926562|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71704369|NCT00106535|142926563|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71704370|NCT00106535|142926563|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71704371|NCT00106535|142926564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71704372|NCT00106535|142926564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71704373|NCT00106535|142926573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
71704374|NCT00106535|142926573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
71704375|NCT00106535|142926574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.26|||<|0.0001|TWO_SIDED|95.0|-96.96|-43.56|||ANOVA|Adjusted for region and original treatment group.||||-43.56|-96.96|<0.0001
71704376|NCT00106535|142926574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.95|||<|0.0001|TWO_SIDED|95.0|-112.69|-59.22|||ANOVA|Adjusted for region and original treatment group.||||-59.22|-112.69|<0.0001
71704377|NCT00106535|142926576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.1|||<|0.0001|TWO_SIDED|95.0|-205.22|-90.98|||ANOVA|Adjusted for region.||||-90.98|-205.22|<0.0001
71763248|NCT00147069|143028268|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
71763249|NCT02160899|143028298|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71763250|NCT02160899|143028298|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71763251|NCT02160899|143028298|SUPERIORITY|||||||0.044|||||||Exact Wilcoxon Rank Sum Test|||||||0.044
71763252|NCT01256294|143028300|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02|||||TWO_SIDED|95.0|0.96|1.09||||||||1.09|0.96|
71763253|NCT01256294|143028300|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.02||||0.486|TWO_SIDED|90.0|0.97|1.08||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of AUC0-12h were assessed relative to the interval \[80%, 125%\].||1.08|0.97|0.486
71825511|NCT00558363|143155328|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.5||Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy|||0.50|0.23|<0.001
71825512|NCT00558363|143155338|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 57% versus 28%|Mantel-Haenszel Chi-Square|||||||<0.001
71825513|NCT00558363|143155339|SUPERIORITY_OR_OTHER||Relative Risk (Hazard Ratio)|0.25|||<|0.001||95.0|0.14|0.45||Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy|||0.45|0.14|<0.001
71652573|NCT03660241|142823593|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|269.78|||||TWO_SIDED|90.0|196.61|370.18|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||370.18|196.61|
71652574|NCT03660241|142823593|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|571.43|||||TWO_SIDED|90.0|447.27|730.05|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||730.05|447.27|
71652575|NCT03660241|142823598|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|133.87|||||TWO_SIDED|90.0|102.45|174.92|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||174.92|102.45|
71652576|NCT03660241|142823598|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|129.49|||||TWO_SIDED|90.0|92.86|180.57|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||180.57|92.86|
71652577|NCT03660241|142823599|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|210.2|||||TWO_SIDED|90.0|154.6|285.8|||ANOVA|||Test: the moderate renal impairment group; Reference: the normal renal function group||285.80|154.60|
71652578|NCT03660241|142823599|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of adjusted geometric means|290.68|||||TWO_SIDED|90.0|217.39|388.69|||ANOVA|||Test: the severe renal impairment group; Reference: the normal renal function group||388.69|217.39|
71652579|NCT00441350|142823600|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71652580|NCT00441350|142823601|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
71652581|NCT00441350|142823602|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
71652582|NCT00441350|142823603|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71652583|NCT00255151|142823611|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71652584|NCT00255151|142823611|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71652585|NCT00255151|142823611|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
71704378|NCT00106535|142926576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-181.4|||<|0.0001|TWO_SIDED|95.0|-238.6|-124.21|||ANOVA|Adjusted for region.||||-124.21|-238.60|<0.0001
71704379|NCT00106535|142926601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5212.28|||<|0.0001|TWO_SIDED|95.0|3139.4|7285.16|||ANOVA|Adjusted for region.||||7285.16|3139.40|<0.0001
71704380|NCT00106535|142926601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7092.76|||<|0.0001|TWO_SIDED|95.0|5066.16|9119.36||Adjusted for region.|ANOVA|||||9119.36|5066.16|<0.0001
71704381|NCT00106535|142926617|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Van Elteren's test|Stratified by region.||||||0.0023
71704382|NCT00106535|142926617|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|||||||<0.0001
71704383|NCT00106535|142926618|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||0.0001
71704384|NCT00106535|142926618|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's test|Stratified by region.||||||<0.0001
71704385|NCT01666314|142926681|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED||||||Fisher Exact|||||||0.1078
71704386|NCT01666314|142926682|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.145||||0.0355|TWO_SIDED|95.0|0.9895|18.7606|||Fisher Exact||Odds ratio \>1 favors orteronel.|||18.7606|0.9895|0.0355
71704387|NCT01301092|142926703|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.443|||||TWO_SIDED|90.0|0.395|0.497|||Mixed Linear effects model analyses|||||0.497|0.395|
71704388|NCT01301092|142926704|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.1|||||TWO_SIDED|90.0|1.84|2.41|||Mixed Linear effects model analyses|||||2.41|1.84|
71704389|NCT01301092|142926705|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.962|||||TWO_SIDED|90.0|0.858|1.08|||Mixed Linear effects model analyses|||||1.08|0.858|
71704390|NCT01301092|142926706|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.924|1.19|||Mixed Linear effects model analyses|||||1.19|0.924|
71652586|NCT00255151|142823612|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71652587|NCT00255151|142823612|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71652588|NCT00255151|142823612|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
71652589|NCT00255151|142823614|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71652590|NCT00255151|142823614|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71652591|NCT00255151|142823614|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
71652592|NCT00255151|142823615|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71763254|NCT01256294|143028305|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09|||||TWO_SIDED|95.0|1.0|1.2|||||Ratio of geometric means: Generic tacrolimus/Branded tacrolimus|||1.20|1.00|
71704391|NCT00126737|142926707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.395||||0.0129|TWO_SIDED|95.0|-11.41|-1.38|||ANCOVA|Co-variates entered into the model were BMI and WOMAC function subscale.||||-1.38|-11.41|0.0129
71704392|NCT00126737|142926707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.174||||0.0535|TWO_SIDED|95.0|-10.43|0.079|||ANCOVA|Covariates entered into the model were BMI and WOMAC function||||0.079|-10.43|0.0535
71704393|NCT00126737|142926708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.545||||0.0307|TWO_SIDED|95.0|0.432|8.659|||ANCOVA|||||8.659|0.432|0.0307
71704394|NCT00126737|142926710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.94||||0.0158|TWO_SIDED|95.0|7.655|72.215|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||72.215|7.655|0.0158
71704395|NCT00126737|142926710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.25||||0.0002|TWO_SIDED|95.0|29.97|94.54|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||94.54|29.97|0.0002
71704396|NCT00126737|142926710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.95||||0.0056|TWO_SIDED|95.0|12.54|75.36|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model||||75.36|12.54|0.0056
71704397|NCT00126737|142926711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.129||||0.0018|TWO_SIDED|95.0|10.767|45.492|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||45.492|10.767|0.0018
71704398|NCT00126737|142926711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.71||||0.0024|TWO_SIDED|95.0|9.675|43.746|||ANCOVA|Kellgren Lawrence scale was entered into the model||||43.746|9.675|0.0024
71704399|NCT00126737|142926711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.747||||0.0368|TWO_SIDED|95.0|1.169|36.325|||ANCOVA|Kellgren Lawrence Scale was entered into the model||||36.325|1.169|0.0368
71704400|NCT00422461|142926783|SUPERIORITY||Least square (LS) mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.6||0.0822|TWO_SIDED|95.0|-5.97|0.36|||Nonlinear dose response regression model|||||0.36|-5.97|0.0822
71704401|NCT00422461|142926783|SUPERIORITY||LS mean difference|-4.66|STANDARD_ERROR_OF_MEAN|1.92||0.017|TWO_SIDED|95.0|-8.47|-0.85|||Nonlinear dose response regression model|||||-0.85|-8.47|0.0170
71704402|NCT00422461|142926783|SUPERIORITY||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|2.26||0.0026|TWO_SIDED|95.0|-11.45|-2.48|||Nonlinear dose response regression model|||||-2.48|-11.45|0.0026
71763255|NCT01256294|143028305|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.09||||0.057|TWO_SIDED|90.0|1.01|1.18||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of Cmax were assessed relative to the interval \[80%, 125%\].||1.18|1.01|0.057
71704403|NCT00422461|142926784|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0264|TWO_SIDED|95.0|-5.09|-0.32|||Nonlinear dose response regression model|||||-0.32|-5.09|0.0264
71704404|NCT00422461|142926784|SUPERIORITY||LS mean difference|-4.56|STANDARD_ERROR_OF_MEAN|1.41||0.0016|TWO_SIDED|95.0|-7.35|-1.77|||Nonlinear dose response regression model|||||-1.77|-7.35|0.0016
71704405|NCT00422461|142926784|SUPERIORITY||LS mean difference|-6.96|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-10.03|-3.89|||Nonlinear dose response regression model|||||-3.89|-10.03|<0.0001
71704406|NCT00422461|142926785|SUPERIORITY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.98||0.9479|TWO_SIDED|95.0|-3.79|4.05|||ANCOVA|||For SBP||4.05|-3.79|0.9479
71704407|NCT00422461|142926785|SUPERIORITY||LS mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.03||0.0215|TWO_SIDED|95.0|-8.78|-0.72|||ANCOVA|||For SBP||-0.72|-8.78|0.0215
71704408|NCT00422461|142926785|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.0||0.0886|TWO_SIDED|95.0|-7.39|0.53|||ANCOVA|||For SBP||0.53|-7.39|0.0886
71704409|NCT00422461|142926785|SUPERIORITY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.44||0.3173|TWO_SIDED|95.0|-4.3|1.41|||ANCOVA|||For DBP||1.41|-4.30|0.3173
71704410|NCT00422461|142926785|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|1.42||0.0087|TWO_SIDED|95.0|-6.64|-0.99|||ANCOVA|||For DBP||-0.99|-6.64|0.0087
71704411|NCT00422461|142926785|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.41||0.0062|TWO_SIDED|95.0|-6.76|-1.15|||ANCOVA|||For DBP||-1.15|-6.76|0.0062
71704412|NCT00422461|142926787|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.8091|TWO_SIDED|95.0|-5.51|4.31|||ANCOVA|||For cuff SBP||4.31|-5.51|0.8091
71704413|NCT00422461|142926787|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|2.44||0.8809|TWO_SIDED|95.0|-5.21|4.48|||ANCOVA|||For cuff SBP||4.48|-5.21|0.8809
71704414|NCT00422461|142926787|SUPERIORITY||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.46||0.0382|TWO_SIDED|95.0|-10.04|-0.29|||ANCOVA|||For cuff SBP||-0.29|-10.04|0.0382
71704415|NCT00422461|142926787|SUPERIORITY||LS mean difference|-3.03|STANDARD_ERROR_OF_MEAN|1.67||0.0731|TWO_SIDED|95.0|-6.35|0.29|||ANCOVA|||For cuff DBP||0.29|-6.35|0.0731
71774903|NCT01051466|143050112|SUPERIORITY_OR_OTHER|||||||0.518||||||The p-value is for change from baseline activation (BOLD response) in the right amygdala.|Mixed Models Analysis|||||||0.518
71774904|NCT01051466|143050113|SUPERIORITY_OR_OTHER|||||||0.03||||||The p-value is for change from baseline volume in the subgenual anterior cingulate.|Mixed Models Analysis|||||||0.030
71774905|NCT01051466|143050113|SUPERIORITY_OR_OTHER|||||||0.208||||||The p-value is for change from baseline volume in the left amygdalae.|Mixed Models Analysis|||||||0.208
71704416|NCT00422461|142926787|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.65||0.0077|TWO_SIDED|95.0|-7.77|-1.22|||ANCOVA|||For cuff DBP||-1.22|-7.77|0.0077
71704417|NCT00422461|142926787|SUPERIORITY||LS mean difference|-4.29|STANDARD_ERROR_OF_MEAN|1.66||0.0111|TWO_SIDED|95.0|-7.58|-1.0|||ANCOVA|||For cuff DBP||-1.00|-7.58|0.0111
71704418|NCT00422461|142926789|SUPERIORITY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.7||0.2567|TWO_SIDED|95.0|-5.32|1.44|||ANCOVA|||||1.44|-5.32|0.2567
71704419|NCT00422461|142926789|SUPERIORITY||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|1.69||0.086|TWO_SIDED|95.0|-6.29|0.42|||ANCOVA|||||0.42|-6.29|0.0860
71704420|NCT00422461|142926789|SUPERIORITY||LS mean difference|-4.46|STANDARD_ERROR_OF_MEAN|1.71||0.0103|TWO_SIDED|95.0|-7.85|-1.08|||ANCOVA|||||-1.08|-7.85|0.0103
71704421|NCT03593629|142926800|NON_INFERIORITY|Non-inferiority margin was defined as -10%|Risk Difference (RD)|2.37|||||ONE_SIDED|95.0|-5.05||||||||||-5.05|
71704422|NCT03593629|142926801|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-2.6|||||ONE_SIDED|95.0|-8.88||||||||||-8.88|
71652593|NCT00255151|142823615|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71763256|NCT00724711|143028306|NON_INFERIORITY_OR_EQUIVALENCE|"This study was designed to show noninferiority (change of \< 12%) in regard of proportions of responders (TLOVR) at Week 48.~With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than -0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.~312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%."|Difference in percentages between groups|3.0|||||TWO_SIDED|95.0|-5.1|11.2|||Inverted two one-sided tests|Inverted two one-sided tests with the standardized statistic||"Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA \< 200 copies/mL through Week 48 (responder rate, as defined by the TLOVR algorithm)"||11.2|-5.1|
71763257|NCT05111301|143028343|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
71763258|NCT05111301|143028344|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.004
71763259|NCT05111301|143028345|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.54
71652594|NCT00255151|142823615|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
71652595|NCT00934596|142823621|SUPERIORITY_OR_OTHER||Median Difference (Net)|57.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71652596|NCT00934596|142823624|SUPERIORITY_OR_OTHER||Median Difference (Net)|72.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71652597|NCT00934596|142823629|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||As data for these small groups were non-parametric the median and quartiles were used for comparison of groups by the Wilcoxon Rank Sum test.||||<0.001
71652598|NCT01332578|142823633|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.92||||0.0004|TWO_SIDED|95.0|-27.31|-15.81|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of median difference was determined.|Null hypothesis was no difference between test hot drink and standard paracetamol tablets.||-15.81|-27.31|0.0004
71652599|NCT00107042|142823641|SUPERIORITY_OR_OTHER|||||||0.2954|||||||Fisher Exact|||The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.||||0.2954
71652600|NCT00107042|142823641|SUPERIORITY_OR_OTHER||Response Rate|87.23|||||TWO_SIDED|95.0|74.26|95.17|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||95.17|74.26|
71652601|NCT00107042|142823641|SUPERIORITY_OR_OTHER||Response Rate|94.55|||||TWO_SIDED|95.0|84.88|98.86|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here."||98.86|84.88|
71652602|NCT00107042|142823642|SUPERIORITY_OR_OTHER|||||||0.0608|||||||Wilcoxon (Mann-Whitney)|||Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.||||0.0608
71652603|NCT00107042|142823642|SUPERIORITY_OR_OTHER||Mean response|2.29|||||TWO_SIDED|95.0|2.05|2.53|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."||2.53|2.05|
71652604|NCT00107042|142823642|SUPERIORITY_OR_OTHER||Response rate|2.58|||||TWO_SIDED|95.0|2.4|2.76|||95% confidence interval|||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here."||2.76|2.40|
71652605|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.2455|STANDARD_ERROR_OF_MEAN|0.1757||0.1667|||||||Regression, Linear|||This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.1667
71652606|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficent|-0.0025|STANDARD_ERROR_OF_MEAN|0.1792||0.989||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.9890
71652607|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coeffcient|0.2053|STANDARD_ERROR_OF_MEAN|0.1885||0.2796||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2796
71652608|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regresssion coeffcient|-0.4726|STANDARD_ERROR_OF_MEAN|0.1734||0.008||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0080
71763260|NCT05111301|143028346|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.03
71763261|NCT05111301|143028347|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.001
71763262|NCT05111301|143028348|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.01
71763263|NCT05111301|143028349|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||For Control-IQ Versus Baseline||||0.80
71763264|NCT04838977|143028379|SUPERIORITY||Between group difference|-4.2|||||TWO_SIDED|95.0|-7.6|-0.8||||||The null hypothesis is there is no difference in mean CPSS at 10 weeks in the intervention group versus the control group.||-0.8|-7.6|
71774906|NCT01051466|143050113|SUPERIORITY_OR_OTHER|||||||0.031||||||The p-value is for change from baseline volume in the right amygdalae.|Mixed Models Analysis|||||||0.031
71652609|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.2189|STANDARD_ERROR_OF_MEAN|0.1905||0.2543||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2543
71825514|NCT00558363|143155340|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparing percentages of participants with PSA doubling: 35% versus 10%|Mantel-Haenszel Chi-Square|||||||<0.001
71652610|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.2994|STANDARD_ERROR_OF_MEAN|0.3292||0.3661||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.||||0.3661
71652611|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.0083|STANDARD_ERROR_OF_MEAN|0.3497||0.9812||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.||||0.9812
71652612|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0663|STANDARD_ERROR_OF_MEAN|0.2314||0.7766||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7766
71652613|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.2929|STANDARD_ERROR_OF_MEAN|0.2508||0.2492||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.2492
71652614|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coeffcient|-0.316|STANDARD_ERROR_OF_MEAN|0.1826||0.0877||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (\<25.0) vs. Overweight and Obsese (\>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0877
71652615|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0292|STANDARD_ERROR_OF_MEAN|0.0113||0.0117||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.||||0.0117
71652616|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0578|STANDARD_ERROR_OF_MEAN|0.2163||0.7899||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.7899
71652617|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.5339|STANDARD_ERROR_OF_MEAN|0.2803||0.0607||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0607
71652618|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3883|STANDARD_ERROR_OF_MEAN|0.2779||0.167||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. \<= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. \<= 14 year olds is presented."||||0.1670
71652619|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.0344|STANDARD_ERROR_OF_MEAN|0.2065||0.8682||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. \<= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented."||||0.8682
71652620|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.1532|STANDARD_ERROR_OF_MEAN|0.1896||0.4219||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4219
71704423|NCT03593629|142926802|NON_INFERIORITY|non-inferiority margin is defined as -10%|Risk Difference (RD)|-1.15|||||ONE_SIDED|95.0|-6.89||||||||||-6.89|
71704424|NCT01160744|142926867|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.1318|TWO_SIDED|90.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.1318
71704425|NCT01160744|142926867|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.5215|TWO_SIDED|90.0|0.64|1.22|||Log Rank|||||1.22|0.64|0.5215
71704426|NCT01160744|142926868|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||0.1797|TWO_SIDED|90.0|0.9|2.78|||Chi-squared|||||2.78|0.90|0.1797
71704427|NCT01160744|142926868|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.66||||0.007|TWO_SIDED|90.0|1.45|4.86|||Chi-squared|||||4.86|1.45|0.0070
71704428|NCT01160744|142926869|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.8916|TWO_SIDED|90.0|0.74|1.42|||Log Rank|||||1.42|0.74|0.8916
71704429|NCT01160744|142926869|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6847|TWO_SIDED|90.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6847
71704430|NCT01160744|142926872|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0316|TWO_SIDED|90.0|1.22|5.02|||Chi-squared|||||5.02|1.22|0.0316
71704431|NCT01160744|142926872|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.3962|TWO_SIDED|90.0|0.74|2.52|||Chi-squared|||||2.52|0.74|0.3962
71704432|NCT01160744|142926873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1571|TWO_SIDED||||||t-test, 2 sided|||||||0.1571
71704433|NCT01160744|142926873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1597|TWO_SIDED||||||t-test, 2 sided|||||||0.1597
71704434|NCT04676646|142926888|SUPERIORITY||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|95.0|2.89|6.86|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||6.86|2.89|<0.001
71704435|NCT04676646|142926889|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.78|7.55|||GEE model||An odds ratio \>1 indicated increased odds of response on SZC compared to placebo.|||7.55|2.78|<0.001
71704436|NCT04676646|142926890|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.5|7.52|||GEE model||An odds ratio greater than 1 indicated increased odds of response on SZC compared to placebo.|||7.52|2.50|<0.001
71704437|NCT04676646|142926891|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001||95.0|0.37|0.71|||Regression, Cox||A hazard ratio less than 1 favors SZC to be associated with a longer time to first hyperkalaemia episode than placebo.|||0.71|0.37|<0.001
71704438|NCT04676646|142926892|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.006|TWO_SIDED|95.0|0.17|0.73|||Regression, Cox||A hazard ratio less than 1 favored SZC to be associated with a longer time to first instance of a decrease of spironolactone dose due to hyperkalaemia than placebo.|||0.73|0.17|0.006
71704439|NCT04676646|142926893|SUPERIORITY||Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|2.84||0.724|TWO_SIDED|95.0|-6.64|4.63|||t-test, 2 sided||A least-squares mean difference greater than 0 favors SZC compared to placebo.|||4.63|-6.64|0.724
71704440|NCT04270760|142926895|SUPERIORITY||Treatment difference|-70.51|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-75.12|-65.9||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Group 1 versus (vs) Group 5||-65.90|-75.12|<0.001
71704441|NCT04270760|142926895|SUPERIORITY||Treatment difference|-97.38|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-101.98|-92.77||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Group 2 vs Group 5||-92.77|-101.98|<0.001
71704442|NCT04270760|142926895|SUPERIORITY||Treatment difference|-101.13|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.79|-96.47||Adjusted p-value is reported based on the Hochberg procedure to control the type I error for multiple comparisons. Each individual adjusted p-value is compared to 0.05 to determine statistical significance.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Group 3 vs Group 5||-96.47|-105.79|<0.001
71704443|NCT04270760|142926895|SUPERIORITY||Treatment difference|-100.49|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-105.16|-95.82|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Group 4 vs Group 5||-95.82|-105.16|< 0.001
71704444|NCT04270760|142926896|SUPERIORITY||Treatment difference|-68.47|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-74.27|-62.67|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Group 1 vs Group 5||-62.67|-74.27|<0.001
71704445|NCT04270760|142926896|SUPERIORITY||Treatment difference|-96.12|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-101.92|-90.33|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Group 2 vs Group 5||-90.33|-101.92|<0.001
71704446|NCT04270760|142926896|SUPERIORITY||Treatment difference|-100.88|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-106.74|-95.02|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Group 3 vs Group 5||-95.02|-106.74|<0.001
71763265|NCT04780919|143028398|SUPERIORITY|||||||0.722||||||p-value is adjusted to comparison between the Group A and Group B at 3 weeks follow-up after the last application.|Two-way ANOVA|||The Group A will have significantly decreased Cross Section Area compared to Group B at 3 weeks follow up after last application.||||0.722
71704447|NCT04270760|142926896|SUPERIORITY||Treatment difference|-85.94|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-91.83|-80.06|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Group 4 vs Group 5||-80.06|-91.83|< 0.001
71704448|NCT04270760|142926897|SUPERIORITY||Treatment difference|-23.659|STANDARD_ERROR_OF_MEAN|5.874|<|0.001|TWO_SIDED|95.0|-35.176|-12.143|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-12.143|-35.176|<0.001
71704449|NCT04270760|142926897|SUPERIORITY||Treatment difference|-22.518|STANDARD_ERROR_OF_MEAN|5.875|<|0.001|TWO_SIDED|95.0|-34.036|-11.0|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-11.000|-34.036|<0.001
71774907|NCT01051466|143050113|SUPERIORITY_OR_OTHER|||||||0.35||||||The p-value is for change from baseline volume in the left hippocampus.|Mixed Models Analysis|||||||0.350
71774908|NCT01051466|143050113|SUPERIORITY_OR_OTHER|||||||0.191||||||The p-value is for change from baseline volume in the right hippocampus.|Mixed Models Analysis|||||||0.191
71774909|NCT01051466|143050114|SUPERIORITY_OR_OTHER|||||||0.174||||||The p-value is for Gsα translocation in RBCs at Week 1.|Mixed Models Analysis|||||||0.174
71774910|NCT01051466|143050114|SUPERIORITY_OR_OTHER|||||||0.488||||||The p-value is for Gsα translocation in RBCs at Week 8.|Mixed Models Analysis|||||||0.488
71704450|NCT04270760|142926897|SUPERIORITY||Treatment difference|-22.967|STANDARD_ERROR_OF_MEAN|5.962|<|0.001|TWO_SIDED|95.0|-34.656|-11.278|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-11.278|-34.656|<0.001
71704451|NCT04270760|142926897|SUPERIORITY||Treatment difference|-24.696|STANDARD_ERROR_OF_MEAN|5.969|<|0.001|TWO_SIDED|95.0|-36.399|-12.993|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-12.993|-36.399|< 0.001
71704452|NCT04270760|142926897|SUPERIORITY||Treatment difference|-24.856|STANDARD_ERROR_OF_MEAN|6.119|<|0.001|TWO_SIDED|95.0|-36.853|-12.859|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-12.859|-36.853|<0.001
71704453|NCT04270760|142926897|SUPERIORITY||Treatment difference|-21.594|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-33.59|-9.598|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-9.598|-33.590|<0.001
71704454|NCT04270760|142926897|SUPERIORITY||Treatment difference|-27.421|STANDARD_ERROR_OF_MEAN|6.194|<|0.001|TWO_SIDED|95.0|-39.565|-15.277|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-15.277|-39.565|<0.001
71704455|NCT04270760|142926897|SUPERIORITY||Treatment difference|-27.021|STANDARD_ERROR_OF_MEAN|6.232|<|0.001|TWO_SIDED|95.0|-39.24|-14.801|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-14.801|-39.240|<0.001
71704456|NCT04270760|142926898|SUPERIORITY||Treatment difference|-18.89|STANDARD_ERROR_OF_MEAN|3.779|<|0.001|TWO_SIDED|95.0|-26.303|-11.477|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 1 vs Group 5||-11.477|-26.303|<0.001
71704457|NCT04270760|142926898|SUPERIORITY||Treatment difference|-16.696|STANDARD_ERROR_OF_MEAN|3.778|<|0.001|TWO_SIDED|95.0|-24.107|-9.284|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 2 vs Group 5||-9.284|-24.107|<0.001
71763266|NCT04780919|143028399|SUPERIORITY|||||||0.096||||||p-value is adjusted to comparison between the Group A and Group B in the timeframe of the last application.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B in the timeframe of the last application compared to baseline.||||0.096
71763267|NCT04780919|143028400|SUPERIORITY|||||||0.035||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum pain will decrease significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.035
71763268|NCT04780919|143028401|SUPERIORITY|||||||0.171||||||p-value is adjusted to comparison between the Group A and Group B at the 3 weeks follow up compared to baseline.|Two-way ANOVA|||The maximum of ankle dorsiflexion range of motion will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.171
71763269|NCT04780919|143028404|SUPERIORITY|||||||0.104||||||p-value is adjusted to comparison between the Group A and Group B in 3 weeks follow up after the last application.|Two-way ANOVA|||The VISA-A score will increase significantly more in Group A compared to Group B at the 3 weeks follow up compared to baseline.||||0.104
71763270|NCT00621348|143028426|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|Risk Ratio (RR)|0.12|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|95.0|0.016|0.93||p value was adjusted for multiple comparisons.|Fisher Exact||The risk ratio is for Group A compared with Group C.|The incidence of hospital-acquired hyponatremia with current standard intravenous fluid therapy was approximately 30%. Sample of 72 patients would be needed in each group to demonstrate the decrease in incidence of hyponatremia (defined as plasma sodium\< 130 mEq/L) to 10%, with a power of 80 percent and alpha error of 0.05. In view of short study period and feasibility it was planned a priori to enroll at least 50 patients in each treatment limb.||0.93|0.016|<0.05
71763271|NCT03120351|143028439|SUPERIORITY||Mean Difference (Net)|-2.5||||0.28|TWO_SIDED|95.0|-7.11|2.06|||Mixed Models Analysis|||||2.06|-7.11|0.28
71704458|NCT04270760|142926898|SUPERIORITY||Treatment difference|-17.635|STANDARD_ERROR_OF_MEAN|3.825|<|0.001|TWO_SIDED|95.0|-25.139|-10.131|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 3 vs Group 5||-10.131|-25.139|<0.001
71704459|NCT04270760|142926898|SUPERIORITY||Treatment difference|-18.772|STANDARD_ERROR_OF_MEAN|3.839|<|0.001|TWO_SIDED|95.0|-26.303|-11.241|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 36.|Week 36: Group 4 vs Group 5||-11.241|-26.303|< 0.001
71763272|NCT01256190|143028440|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71763273|NCT01256190|143028441|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
71763274|NCT01256190|143028442|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||intent-to-treat analysis||||.022
71763275|NCT01256190|143028443|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Fisher Exact|||intent-to treat analysis||||0.113
71652621|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.7752|STANDARD_ERROR_OF_MEAN|0.242||0.002||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0020
71763276|NCT01256190|143028444|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Fisher Exact|||intent-to-treat analysis||||.025
71652622|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.2921|STANDARD_ERROR_OF_MEAN|0.2086||0.1659||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.1659
71652623|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-1.6163|STANDARD_ERROR_OF_MEAN|0.2839||0||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.0000
71652624|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1788|STANDARD_ERROR_OF_MEAN|0.2463||0.4701||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.||||0.4701
71652625|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|0.1083|STANDARD_ERROR_OF_MEAN|0.3488||0.7572||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. \>= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. \>= 6 partners is presented.||||0.7572
71652626|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.0307|STANDARD_ERROR_OF_MEAN|0.1809||0.8657||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.8657
71652627|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3548|STANDARD_ERROR_OF_MEAN|0.2076||0.0917||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.0917
71652628|NCT00107042|142823645|SUPERIORITY_OR_OTHER||Regression coefficient|-0.3474|STANDARD_ERROR_OF_MEAN|0.3924||0.3788||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.||||0.3788
71652629|NCT00107042|142823646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.2068|TWO_SIDED|95.0|0.6|10.76|||Univariate regression, logistic||The reference group is the 'Recombivax' group.|||10.76|0.60|0.2068
71652630|NCT00107042|142823647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.5524|TWO_SIDED|95.0|0.38|6.01|||Univariate regression, logistic||The reference group is the 'Other Sites' group.|||6.01|0.38|0.5524
71652631|NCT00107042|142823648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4646|TWO_SIDED|95.0|0.36|9.36|||Univariate regression, logistic||The reference group is the '15-17 year' age group|||9.36|0.36|0.4646
71652632|NCT00107042|142823649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.339|TWO_SIDED|95.0|0.09|2.3|||Univariate regression, logistic||The reference group is the 'Female' group.|||2.30|0.09|0.3390
71652633|NCT00107042|142823650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.86||||0.0102|TWO_SIDED|95.0|1.58|29.78|||Univariate regression, logistic||The reference group is the 'Hispanic: NO' group.|||29.78|1.58|0.0102
71652634|NCT00107042|142823650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.38||||0.0118|TWO_SIDED|95.0|1.56|34.95||Since Hispanic (no, yes) was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Hispanic: NO group."|||34.95|1.56|0.0118
71652635|NCT00107042|142823651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.4241|TWO_SIDED|95.0|0.04|3.84|||Univariate regression, logistic||The reference group is the 'White' group.|||3.84|0.04|0.4241
71652636|NCT00107042|142823651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12||||0.2685|TWO_SIDED|95.0|0.34|50.76|||Univariate regression, logistic||The reference group is the 'White' group.|||50.76|0.34|0.2685
71652637|NCT00107042|142823652|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.939|TWO_SIDED|95.0|0.05|15.44|||Univariate regression, logistic||The reference group is the 'Stage 5' group.|||15.44|0.05|0.9390
71652638|NCT00107042|142823653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6181|TWO_SIDED|95.0|0.3|7.39|||Univariate regression, logistic||"The reference group is the Stage 5 group."|||7.39|0.30|0.6181
71652639|NCT00107042|142823654|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.1943|TWO_SIDED|95.0|0.1|1.6|||Univariate regression, logistic||"The reference group is the Normal and Underweight (\<25.0) group."|||1.60|0.10|0.1943
71652640|NCT00107042|142823655|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.2542|TWO_SIDED|95.0|0.1|1.86|||Univariate regression, logistic||"The reference group is the Ever smoked cigarettes: NO group."|||1.86|0.10|0.2542
71652641|NCT00107042|142823656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.14||||0.0161|TWO_SIDED|95.0|0.03|0.69|||Univariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.69|0.03|0.0161
71652642|NCT00107042|142823656|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.0222|TWO_SIDED|95.0|0.02|0.74||Since sexual identity was a factor with a p-value of \< 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Straight (heterosexual) group."|||0.74|0.02|0.0222
71774911|NCT01051466|143050114|SUPERIORITY_OR_OTHER|||||||0.48||||||The p-value is for Gsα translocation in RBCs at Week 12.|Mixed Models Analysis|||||||0.480
71652643|NCT00107042|142823657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8945|TWO_SIDED|95.0|0.12|11.83|||Univariate regression, logistic||"The reference group is the Never (had sex)group."|||11.83|0.12|0.8945
71652644|NCT00107042|142823657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12||||0.019|TWO_SIDED|95.0|0.02|0.7|||Univariate regression, logistic||"The reference group is the Never (had sex) group."|||0.70|0.02|0.0190
71652645|NCT00107042|142823658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.0042|TWO_SIDED|95.0|0.01|0.48|||Univariate regression, logistic||"The reference group is the 0 partners group"|||0.48|0.01|0.0042
71652646|NCT00107042|142823658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.6893||95.0|||||Univariate regression, Logistic||"The reference group is the 0 partners group.~Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity"|||||0.6893
71652647|NCT00107042|142823659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.015||||0.0003|TWO_SIDED|95.0|0.0|0.19|||Univariate regression, logistic||"The reference group is hte 0 Partners group."|||0.19|0.00|0.0003
71704460|NCT04270760|142926898|SUPERIORITY||Treatment difference|-20.04|STANDARD_ERROR_OF_MEAN|4.443|<|0.001|TWO_SIDED|95.0|-28.757|-11.323|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 1 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 1 vs Group 5||-11.323|-28.757|<0.001
71704461|NCT04270760|142926898|SUPERIORITY||Treatment difference|-17.06|STANDARD_ERROR_OF_MEAN|4.442|<|0.001|TWO_SIDED|95.0|-25.774|-8.345|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 2 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 2 vs Group 5||-8.345|-25.774|<0.001
71704462|NCT04270760|142926898|SUPERIORITY||Treatment difference|-19.509|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-28.336|-10.682|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 3 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 3 vs Group 5||-10.682|-28.336|<0.001
71704463|NCT04270760|142926898|SUPERIORITY||Treatment difference|-21.839|STANDARD_ERROR_OF_MEAN|4.517|<|0.001|TWO_SIDED|95.0|-30.7|-12.979|||Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit as covariates.|Treatment difference = percentage change in Group 4 - percentage change in Group 5 from Baseline at Week 48.|Week 48: Group 4 vs Group 5||-12.979|-30.700|<0.001
71704464|NCT02421510|142926900|SUPERIORITY||Least squares mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.058|<|0.001|TWO_SIDED|95.0|-0.48|-0.25||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||-0.25|-0.48|< 0.001
71704465|NCT02421510|142926900|SUPERIORITY||Least squares mean difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.47|-0.24||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from Mixed effect Model Repeat Measurement (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C- by-time interaction as a covariate.||-0.24|-0.47|< 0.001
71704466|NCT02421510|142926901|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|16.3|||<|0.001|TWO_SIDED|95.0|9.17|23.43||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 200 mg versus Placebo|P-values were obtained from a Cochran-Mantel-Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%). The 95% Confidence Limits (CL) were calculated using asymptotic Wald method. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.||23.43|9.17|< 0.001
71704467|NCT02421510|142926901|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|17.2|||<|0.001|TWO_SIDED|95.0|10.06|24.35||Threshold for significance \<= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 400 mg versus Placebo|P-values were obtained from a CMH test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%). The 95% CL were calculated using asymptotic Wald method.||24.35|10.06|< 0.001
71774912|NCT01051466|143050114|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for Gsα translocation in platelets at Week 1.|Mixed Models Analysis|||||||0.925
71652648|NCT00107042|142823659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||1|TWO_SIDED|95.0|0.0|10.01|||Univariate regression, Logistic||"The reference group is the 0 Partners group"|||10.01|0.00|1.0000
71652649|NCT00107042|142823660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.5503|TWO_SIDED|95.0|0.05|4.86|||Univariate regression, logistic||"The reference group is the 0 Partners group"|||4.86|0.05|0.5503
71652650|NCT00107042|142823660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8904|TWO_SIDED|95.0|0.13|10.46|||Univariate Regression, Logistic||"The reference group is the 0 Partners group."|||10.46|0.13|0.8904
71652651|NCT00107042|142823661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.301|TWO_SIDED|95.0|0.12|1.92|||Univariate regression, logistic||"The reference group is the Ever drank alcohol: NO group."|||1.92|0.12|0.3010
71763277|NCT02834793|143028445|SUPERIORITY||Median Difference (Net)|-19.3|||=|0.107|TWO_SIDED|95.0|-49.2|4.8||The p-value was based on a rank analysis of covariance (ANCOVA) with treatment, region, and age-group as factors, and prerandomization drop seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95 percent (%) confidence interval (CI) were based on the Hodges-Lehmann method.|||4.8|-49.2|= 0.107
71763278|NCT02197078|143028476|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.03||||||||1.03|0.66|
71763279|NCT02197078|143028476|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.65|1.1||||||||1.10|0.65|
71763280|NCT02197078|143028476|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.49|0.86||||||||0.86|0.49|
71704468|NCT02421510|142926902|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.53|-1.44||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-1.44|-2.53|< 0.001
71763281|NCT02197078|143028476|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.1||||||||1.10|0.83|
71652652|NCT00107042|142823662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.0501|TWO_SIDED|95.0|0.06|1.0|||Univariate regression, logistic||"The reference group is the Ever smoked marijuana: NO group."|||1.00|0.06|0.0501
71652653|NCT00107042|142823663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.3846|TWO_SIDED|95.0|0.04|3.61|||Univariate regression, logistic||"The reference group is the Ever used drugs not prescribed: NO group."|||3.61|0.04|0.3846
71763282|NCT02197078|143028476|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.85|1.19||||||||1.19|0.85|
71652654|NCT00107042|142823664|SUPERIORITY_OR_OTHER|||||||0.3827||95.0|||||Fisher Exact|||||||0.3827
71652655|NCT00107042|142823664|SUPERIORITY_OR_OTHER||Responding Rate|81.08|||||TWO_SIDED|95.0|68.84|92.04|||||Response rate=Total number subjects responded/Total number subjects in arm|||92.04|68.84|
71739313|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.893||||0.793|TWO_SIDED|95.0|0.385|2.074|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.074|0.385|0.7930
71763283|NCT02197078|143028476|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.66|0.96||||||||0.96|0.66|
71763284|NCT02197078|143028477|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.23||||||||1.23|0.66|
71763285|NCT02197078|143028477|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
71763286|NCT02197078|143028477|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.01||||||||1.01|0.48|
71763287|NCT02197078|143028477|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
71652656|NCT00107042|142823664|SUPERIORITY_OR_OTHER||Responding Rate|88.0|||||TWO_SIDED|95.0|75.69|95.47|||||Response rate=Total number subjects responded/Total number subjects in arm|||95.47|75.69|
71652657|NCT00107042|142823665|SUPERIORITY_OR_OTHER||Responding rate|98.08|||||TWO_SIDED|95.0|89.74|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% CI|||||99.95|89.74|
71652658|NCT00107042|142823666|SUPERIORITY_OR_OTHER||Responding Rate|91.49||||||95.0|79.62|97.63||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95 % confidence interval|||||97.63|79.62|
71739314|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.167||||0.7386|TWO_SIDED|95.0|0.471|2.892|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.892|0.471|0.7386
71739315|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.9354|TWO_SIDED|95.0|0.437|2.46|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||2.460|0.437|0.9354
71739316|NCT00999518|142991312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.805||||0.6207|TWO_SIDED|95.0|0.341|1.899|||Regression, Logistic|||Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.||1.899|0.341|0.6207
71739317|NCT00122369|142991344|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant|t-test, 2 sided|||The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.||||0.014
71739318|NCT00122369|142991344|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.421
71739319|NCT00122369|142991344|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||Bonferoni correction was made so that results with p\<0.0167 are considered significant.|t-test, 2 sided|||||||0.138
71739320|NCT00122369|142991345|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||The null-hypothesis was that there would be no difference among groups.||||0.56
71739321|NCT00122369|142991357|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71739322|NCT00122369|142991357|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Ordinal regression|||||||0.45
71739323|NCT00122369|142991357|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71739324|NCT00122369|142991357|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
71763288|NCT02197078|143028477|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.28||||||||1.28|0.79|
71652659|NCT00107042|142823667|SUPERIORITY_OR_OTHER||Responding Rate %|98.11|||||TWO_SIDED|95.0|89.93|99.95||A p-value has not been entered because there is only one study arm in this analysis.|Exact 95% confidence interval||"For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered Positive. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is Negative."|||99.95|89.93|
71763289|NCT02197078|143028477|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.06||||||||1.06|0.62|
71763290|NCT02197078|143028478|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.51|0.94||||||||0.94|0.51|
71763291|NCT02197078|143028478|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9||||||||0.90|0.44|
71763292|NCT02197078|143028478|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.41|0.88||||||||0.88|0.41|
71763293|NCT02197078|143028478|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
71763294|NCT02197078|143028478|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||||1.19|0.77|
71763295|NCT02197078|143028478|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
71763296|NCT02197078|143028479|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.58|1.38||||||||1.38|0.58|
71763297|NCT02197078|143028479|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
71763298|NCT02197078|143028479|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.24|0.78||||||||0.78|0.24|
71763299|NCT02197078|143028479|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.73|1.25||||||||1.25|0.73|
71763300|NCT02197078|143028479|OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.78|1.52||||||||1.52|0.78|
71763301|NCT02197078|143028479|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05||||||||1.05|0.52|
71763302|NCT02197078|143028480|OTHER||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.1|2.18||||||||2.18|1.10|
71763303|NCT02197078|143028480|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.19|3.03||||||||3.03|1.19|
71763304|NCT02197078|143028480|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||||1.68|0.73|
71763305|NCT02197078|143028480|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.76|1.29||||||||1.29|0.76|
71763306|NCT02197078|143028480|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.77|1.56||||||||1.56|0.77|
71763307|NCT02197078|143028480|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14||||||||1.14|0.54|
71763308|NCT02197078|143028481|OTHER||Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.97|2.0||||||||2.00|0.97|
71763309|NCT02197078|143028481|OTHER||Hazard Ratio (HR)|1.71|||||TWO_SIDED|95.0|1.07|2.72||||||||2.72|1.07|
71763310|NCT02197078|143028481|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
71763311|NCT02197078|143028481|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|1.01|1.76||||||||1.76|1.01|
71652660|NCT00107042|142823668|SUPERIORITY_OR_OTHER|||||||0.2938||95.0|||||Fisher Exact|||||||0.2938
71652661|NCT00107042|142823668|SUPERIORITY_OR_OTHER||Responding Rate %|85.37|||||TWO_SIDED|95.0|70.83|94.43|||95 % confidence interval|||||94.43|70.83|
71652662|NCT00107042|142823668|SUPERIORITY_OR_OTHER||Responding Rate %|93.62|||||TWO_SIDED|95.0|82.46|98.66|||95% confidence interval|||||98.66|82.46|
71652663|NCT01221090|142823671|SUPERIORITY_OR_OTHER|||||||0.771||95.0||||A priori threshold for statistical significance is \<0.05|Likelihood Ratio Tests|||We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time \& treatment effects were added gradually and evaluated with likelihood ratio tests.||||0.771
71652664|NCT01221090|142823672|SUPERIORITY_OR_OTHER|||||||0.2176||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimates.||||||0.2176
71652665|NCT01221090|142823673|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||A priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.572
71652666|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar."||||0.26
71652667|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times."||||0.21
71652668|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes."||||0.53
71763312|NCT02197078|143028481|OTHER||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27||||||||2.27|1.02|
71763313|NCT02197078|143028481|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.81|1.71||||||||1.71|0.81|
71763314|NCT02197078|143028482|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.04|1.47||||||||1.47|1.04|
71763315|NCT02197078|143028482|OTHER||Hazard Ratio (HR)|1.31|||||TWO_SIDED|95.0|1.06|1.61||||||||1.61|1.06|
71763316|NCT02197078|143028482|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
71763317|NCT02197078|143028482|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
71763318|NCT02197078|143028482|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||||1.27|0.90|
71763319|NCT02197078|143028482|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.75|1.09||||||||1.09|0.75|
71763320|NCT02197078|143028483|OTHER||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.64|4.06||||||||4.06|0.64|
71763321|NCT02197078|143028483|OTHER||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.61|4.58||||||||4.58|0.61|
71763322|NCT02197078|143028483|OTHER||Hazard Ratio (HR)|1.84|||||TWO_SIDED|95.0|0.62|5.48||||||||5.48|0.62|
71763323|NCT02197078|143028483|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.57|2.4||||||||2.40|0.57|
71763324|NCT02197078|143028483|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.38|2.43||||||||2.43|0.38|
71763325|NCT02197078|143028483|OTHER||Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.64|4.27||||||||4.27|0.64|
71763326|NCT00622440|143028484|OTHER||Wilcoxon Rank Sum Effect Size|0.275||||0.042|TWO_SIDED|95.0|||||Wilcoxon rank sum||The wilcoxon rank sum effect size ranges in strength of effect from small (0.10 - \< 0.30), to medium (0.30 - \< 0.50), to large (\>=0.50) with a total range of 0 to 1|Estimated Effect Size for Phase 3 Trial||||.042
71704469|NCT02421510|142926902|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-3.12|-2.04|||MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.||-2.04|-3.12|< 0.001
71704470|NCT02421510|142926903|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.847|<|0.001|TWO_SIDED|95.0|-4.86|-1.53||Threshold for significance \<=0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.53|-4.86|< 0.001
71704471|NCT02421510|142926903|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.59|STANDARD_ERROR_OF_MEAN|0.845|<|0.001|TWO_SIDED|95.0|-5.25|-1.93||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-1.93|-5.25|< 0.001
71825515|NCT03102710|143155353|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for lidocaine before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2.|Mean Difference (Final Values)|0.4||||0.03|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 0.4, between cathodal vs. sham was 1.2, and between anodal vs. cathodal was -0.8.|To assess the modulation effects of tDCS on placebo, we first performed an analysis of covariance (ANCOVA) with placebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.03
71704472|NCT02421510|142926904|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-21.6|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-32.2|-11.0||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-11|-32.2|< 0.001
71704473|NCT02421510|142926904|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.37|<|0.001|TWO_SIDED|95.0|-36.2|-15.1||Threshold for significance \<= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.||-15.1|-36.2|< 0.001
71704474|NCT02421510|142926905|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.3|2.7||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.7|1.3|< 0.001
71738855|NCT02106403|142990599|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.32|||<|0.0001|TWO_SIDED|95.0|8.41|20.22|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||20.22|8.41|<0.0001
71739325|NCT00122369|142991357|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Proportional odds model|||||||<0.001
71739326|NCT00122369|142991357|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Proportional odds model|||||||<0.01
71739327|NCT00122369|142991370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71763327|NCT03023813|143028491|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
71652669|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session."||||0.24
71652670|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet."||||0.18
71652671|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet."||||0.19
71652672|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet."||||0.87
71652673|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes."||||0.53
71652674|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes."||||0.32
71652675|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan."||||0.37
71652676|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates."||||0.72
71652677|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables."||||0.59
71652678|NCT01221090|142823674|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods."||||<0.004
71652679|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts)."||||0.66
71652680|NCT01221090|142823674|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||A priori threshold for statistical significance is \<0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan."||||0.68
71652681|NCT01221090|142823675|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust Variance Estimation.||"This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit."||||0.685
71652682|NCT01221090|142823675|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days mental health was not good in the past 30 days at the 12 month follow-up visit."||||0.997
71652683|NCT01221090|142823675|SUPERIORITY_OR_OTHER|||||||0.3067||95.0||||A priori threshold for statistical significance is \<0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days poor physical/mental health prevented usual activity in the past 30 days at the 12 month follow-up visit."||||0.3067
71652684|NCT02597582|142823732|NON_INFERIORITY_OR_EQUIVALENCE|"A previous study found that the mean operation time was 165 minutes for patients undergoing LigaSure vessel sealing system-assisted total laryngectomy plus neck dissection and 195 minutes for those receiving conventional hemostasis.~With a difference in operative duration of 30 minutes between the two groups,9 the estimated sample size needed to demonstrate a two-sided significance level of 0.05 with 80% power should be at least 18 participants in each treatment arm."||||||0.022|||||||t-test, 2 sided|||||||0.022
71652685|NCT02597582|142823733|NON_INFERIORITY_OR_EQUIVALENCE|As above||||||0.266|||||||t-test, 2 sided|||||||0.266
71652686|NCT02597582|142823734|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.06|||||||t-test, 2 sided|||||||0.060
71652687|NCT02597582|142823736|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.524|||||||t-test, 2 sided|||||||0.524
71652688|NCT02597582|142823737|NON_INFERIORITY_OR_EQUIVALENCE|as above||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
71652689|NCT00440466|142823743|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.|Difference of Least Squares Means|-0.03|STANDARD_ERROR_OF_MEAN|0.092|||TWO_SIDED|95.0|-0.208|0.153|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.153|-0.208|
71652690|NCT00440466|142823743|NON_INFERIORITY_OR_EQUIVALENCE|Under the same assumptions in the sample size calculation for the QW and the Q2W, 100 subjects would be needed for the Q4W. However, because Study EPO-AKD-3001 and the current study both included QW and Q2W groups, the sample size would add up to 200 for each group if combined, the sample size in the Q4W group in the current study was increased to 200 subjects in order to enroll a comparable and sufficiently large number of subjects in each of the 3 extended dosing groups across the 2 studies.|Difference of Least Squares Means|-0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.249|0.063|||ANCOVA|||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-4-weeks (Q4W) and once-weekly (QW) groups would be lower than -1 g/dL.||0.063|-0.249|
71652691|NCT00440466|142823745|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|0.1|21.7|||95% Confidence Interval|||||21.7|0.1|
71652692|NCT00440466|142823745|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-9.1|11.2|||95% of Confidence Interval|||||11.2|-9.1|
71825516|NCT03102710|143155353|SUPERIORITY|Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for capsaicin before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2. In addition, we added the STAI state and trait anxiety scores as covariates when assessing the modulation effects of tDCS on the nocebo effect, as previous studies have suggested that anxiety level could affect nocebo hyperalgesia.|Mean Difference (Final Values)|1.3||||0.04|TWO_SIDED|||||The threshold for significance was \<0.05.|ANCOVA||The mean difference between anodal vs. sham was 1.4, between cathodal vs. sham was 1.0, and between anodal vs. cathodal was -0.3.|To assess the modulation effects of tDCS on nocebo, we first performed an analysis of covariance (ANCOVA) with nocebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor.||||0.04
71825517|NCT01101165|143155369|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|96.6|||||TWO_SIDED|90.0|92.8|100.56|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||100.56|92.80|
71652693|NCT00440466|142823746|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.13|||||TWO_SIDED|95.0|-0.113|0.372|||ANOVA|||||0.372|-0.113|
71652694|NCT00440466|142823746|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.098|0.32|||ANOVA|||||0.320|-0.098|
71652695|NCT00440466|142823747|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.2|||||TWO_SIDED|95.0|-2.0|18.3|||95% of Confidence Interval|||||18.3|-2.0|
71652696|NCT00440466|142823747|SUPERIORITY_OR_OTHER||Difference in percentage of participants|10.3||||||95.0|1.5|19.2|||95% of Confidence Interval|||||19.2|1.5|
71652697|NCT00440466|142823748|SUPERIORITY_OR_OTHER||Difference in percentage of participants|5.7|||||TWO_SIDED|95.0|-7.7|19.1|||95% of Confidence Interval|||||19.1|-7.7|
71652698|NCT00440466|142823748|SUPERIORITY_OR_OTHER||Difference in percentage of participants|9.1|||||TWO_SIDED|95.0|-2.5|20.6|||95% of Confidence Interval|||||20.6|-2.5|
71652699|NCT00440466|142823749|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-15.8|9.5|||95% of Confidence Interval|||||9.5|-15.8|
71652700|NCT00440466|142823749|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-3.0|||||TWO_SIDED|95.0|-13.9|8.0|||95% of Confidence Interval|||||8.0|-13.9|
71652701|NCT00440466|142823750|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.08||||||95.0|-0.367|0.208|||ANOVA|||||0.208|-0.367|
71652702|NCT00440466|142823750|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.206|0.289|||ANOVA|||||0.289|-0.206|
71652703|NCT00418522|142823780|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.19|||<|0.0001||95.0|-0.38|0.0|||ANCOVA||A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||0|-0.38|<0.0001
71652704|NCT00418522|142823780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0516||95.0|-0.38|0.0|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||0|-0.38|0.0516
71652705|NCT00418522|142823781|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0052||95.0|1.22|3.14|||Regression, Logistic|||||3.14|1.22|0.0052
71652706|NCT00418522|142823782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0022||95.0|1.29|3.15|||Regression, Logistic|||||3.15|1.29|0.0022
71652707|NCT00418522|142823783|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.248||95.0|0.4|1.27|||Regression, Logistic|||||1.27|0.40|0.2480
71652708|NCT00418522|142823784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.57||||0.6091||95.0|-7.31|12.46|||ANCOVA|||||12.46|-7.31|0.6091
71652709|NCT00418522|142823785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.96|||<|0.0001||95.0|22.66|43.25|||ANCOVA|||Time 0 (fasting) at Week 26.||43.25|22.66|<0.0001
71652710|NCT00418522|142823785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||<|0.0001||95.0|16.55|40.59|||ANCOVA|||Time 30 at Week 26.||40.59|16.55|<0.0001
71652711|NCT00418522|142823785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.96||||0.0044||95.0|5.96|31.96|||ANCOVA|||Time 60 at Week 26.||31.96|5.96|0.0044
71652712|NCT00418522|142823785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.69||||0.3168||95.0|-6.45|19.83|||ANCOVA|||Time 90 at Week 26.||19.83|-6.45|0.3168
71652713|NCT00418522|142823785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.9222||95.0|-12.12|13.39|||ANCOVA|||Time 120 at Week 26.||13.39|-12.12|0.9222
71652714|NCT00418522|142823785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.695||95.0|-14.51|9.69|||ANCOVA|||Time 180 at Week 26.||9.69|-14.51|0.6950
71652715|NCT00418522|142823786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.61||||0.1207||95.0|-21.76|2.54|||ANCOVA|||Post-Breakfast, Week 26.||2.54|-21.76|0.1207
71652716|NCT00418522|142823786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|||<|0.0001||95.0|-39.77|-18.44|||ANCOVA|||Post-Lunch, Week 26.||-18.44|-39.77|<0.0001
71652717|NCT00418522|142823786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.76|||<|0.0001||95.0|-44.17|-23.35|||ANCOVA|||Post-Dinner, Week 26.||-23.35|-44.17|<0.0001
71652718|NCT00418522|142823787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21||||0.0735||95.0|-0.5|10.91|||ANCOVA|||Total Cholesterol at Week 26.||10.91|-0.50|0.0735
71652719|NCT00418522|142823787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.0017||95.0|0.79|3.39|||ANCOVA|||HDL-c at Week 26.||3.39|0.79|0.0017
71652720|NCT00418522|142823787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.1369||95.0|-1.1|7.96|||ANCOVA|||LDL-c at Week 26.||7.96|-1.10|0.1369
71652721|NCT00418522|142823787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26||||0.5684||95.0|-10.4|18.92|||ANCOVA|||Triglycerides at Week 26.||18.92|-10.40|0.5684
71652722|NCT00418522|142823788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.5673||95.0|-0.58|1.06|||ANCOVA|||hs-CRP at Week 26.||1.06|-0.58|0.5673
71704475|NCT02421510|142926905|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|1.0|2.4||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.||2.4|1|< 0.001
71738856|NCT02106403|142990600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.41||||0.0357|TWO_SIDED|95.0|0.44|12.38|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||12.38|0.44|0.0357
71652723|NCT00418522|142823788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.6099||95.0|-2.97|1.75|||ANCOVA|||Leptin at Week 26.||1.75|-2.97|0.6099
71652724|NCT00418522|142823788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.28||||0.7684||95.0|-12.94|17.51|||ANCOVA|||Spot urine microalbumin at Week 26.||17.51|-12.94|0.7684
71652725|NCT00418522|142823789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.5005||95.0|-0.69|1.42|||ANCOVA|||Adiponectin at Week 26.||1.42|-0.69|0.5005
71652726|NCT00418522|142823789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|-0.03|0.04|||ANCOVA|||ApoB at Week 26.||0.04|-0.03|0.6850
71652727|NCT00418522|142823790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.7||||0.1856||95.0|-43.37|160.77|||ANCOVA|||||160.77|-43.37|0.1856
71652728|NCT00418522|142823791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.72||||0.1862||95.0|-51.34|13.89|||ANCOVA|||||13.89|-51.34|0.1862
71652729|NCT00418522|142823797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.0055||95.0|0.35|2.04|||ANCOVA|||||2.04|0.35|0.0055
71652730|NCT00418522|142823798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.0053||95.0|0.12|0.71|||ANCOVA|||||0.71|0.12|0.0053
71652731|NCT00418522|142823800|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.27|||<|0.0001||95.0|-0.47|-0.08|||ANCOVA||A CI approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.||-0.08|-0.47|<0.0001
71652732|NCT00418522|142823800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0062||95.0|-0.47|-0.08|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).||-0.08|-0.47|0.0062
71652733|NCT02695719|142823801|SUPERIORITY||Median Values of CI|1.0||||0.007|TWO_SIDED|95.0|0.1|1.9||No adjustment was made as there was only one primary comparison.|Van Elteren Test|The Van Elteren test is a stratified version of the Wilcoxon-Mann-Whitney test which provides approximate sample size for the van Elteren analysis.|CI was estimated by inverting the hypothesis test.|Assuming equal allocation, a power of 90%, an alpha level of 0.05 for a 2-sided test, a placebo mean of 4 (standard deviation of 2.7), and a treatment mean of 5.9 (standard deviation of 4) for SBM frequency at Week 1 and using Wilcoxon-Mann-Whitney test, a total sample size of 146 is required. Analysis was conducted using van Elteren test.||1.9|0.1|0.007
71652734|NCT01612884|142823841|OTHER|Student's T-test||||||0.85|||||||t-test, 2 sided|||||||0.85
71652735|NCT01612884|142823842|OTHER|Chi-Square||||||0.93|||||||Chi-squared|||||||0.93
71652736|NCT01612884|142823843|OTHER|Chi-Square|||||>|0.05|||||||Chi-squared|||||||>0.05
71652737|NCT02790034|142823850|SUPERIORITY||Mean Difference (Final Values)|-5.292|STANDARD_ERROR_OF_MEAN|11.3184||0.6411|TWO_SIDED|95.0|-27.741|17.157|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||17.157|-27.741|0.6411
71652738|NCT02790034|142823850|SUPERIORITY||Mean Difference (Final Values)|-16.966|STANDARD_ERROR_OF_MEAN|13.1869||0.2011|TWO_SIDED|95.0|-43.119|9.186|||Mixed Models Analysis|||Primary inferential comparison between treatment groups used a restricted maximum likelihood (REML)-based, mixed-effects repeated measures model approach (MMRM) with 95% CI for the difference between treatment groups for % change from baseline in the number of apnea episodes. Model included % change from baseline as response, the fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, and the continuous terms age and baseline value as covariate.||9.186|-43.119|0.2011
71652739|NCT03440424|142823852|OTHER||Percent ratio of geometric mean|157.86|||||TWO_SIDED|90.0|118.18|210.87|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||210.87|118.18|
71652740|NCT03440424|142823852|OTHER||Percent ratio of geometric mean|122.2|||||TWO_SIDED|90.0|91.49|163.24|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||163.24|91.49|
71652741|NCT03440424|142823853|OTHER||Percent ratio of geometric mean|122.31|||||TWO_SIDED|90.0|98.95|151.17|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||151.17|98.95|
71652742|NCT03440424|142823853|OTHER||Percent ratio of geometric mean|103.24|||||TWO_SIDED|90.0|83.53|127.61|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||127.61|83.53|
71763328|NCT03023813|143028492|OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
71763329|NCT03023813|143028493|OTHER|||||||0.39|||||||t-test, 2 sided|||||||.39
71763330|NCT03023813|143028494|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
71763331|NCT03023813|143028495|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
71763332|NCT03023813|143028496|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
71763333|NCT03023813|143028497|OTHER|Percent change in weight (lbs.) since the baseline encounter|Mean Difference (Net)|-2.96||||0.27|TWO_SIDED|95.0|-8.18|2.26|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included weight loss||2.26|-8.18|0.27
71763334|NCT03023813|143028497|OTHER|Change in systolic blood pressure since the baseline encounter (mmHg)|Mean Difference (Net)|-6.42||||0.19|TWO_SIDED|95.0|-16.12|3.27|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included blood pressure control||3.27|-16.12|0.19
71763335|NCT03023813|143028497|OTHER|Percentage point change in HbA1c (%) since the baseline encounter|Mean Difference (Net)|-0.68||||0.24|TWO_SIDED|95.0|-1.82|0.45|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included glycemic control||0.45|-1.82|0.24
71763336|NCT03023813|143028497|OTHER|Percentage point change in 10-year atherosclerotic cardiovascular disease risk (%), as estimated by the American College of Cardiology Pooled Cohort Equations, since the baseline encounter|Mean Difference (Net)|-1.2||||0.34|TWO_SIDED|95.0|-3.65|1.26|||Generalized linear mixed regression||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||1.26|-3.65|0.34
71763337|NCT03023813|143028497|OTHER|Change in low-density lipoprotein (LDL) cholesterol (mg/dL) since the baseline encounter|Mean Difference (Net)|-8.46||||0.36|TWO_SIDED|95.0|-26.63|9.7|||Mixed Models Analysis||Result for intervention arm minus control arm|Among participants whose individualized preventive care recommendations included lipids control||9.70|-26.63|0.36
71763338|NCT03023813|143028497|OTHER|Change in smoking intensity (defined as a change in smoking status from Current Every Day to either Current Some Days or Quit; or from Current Some Days to Quit) since the baseline encounter.|Odds Ratio (OR)|1.2||||0.92|TWO_SIDED|95.0|0.03|45.56|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. OR \<1 indicates reduction in smoking intensity; OR \>1 indicates increase in smoking intensity.|Among participants whose individualized preventive care recommendations included tobacco cessation||45.56|0.03|0.92
71763339|NCT03023813|143028497|OTHER|Receipt of colorectal cancer screening since the baseline encounter|Odds Ratio (OR)|2.52||||0.99|TWO_SIDED|95.0|0.001|1000.0|||Mixed Models Analysis|Generalized linear mixed regression with logit link|Result for intervention arm relative to control arm. Lower limit estimate was \<0.001 and upper limit estimate was \>1000 (ClinicalTrials.gov does not allow \< or \> to be entered into the confidence interval lower limit or upper limit fields).|Among participants whose individualized preventive care recommendations included colorectal cancer screening||1000|0.001|0.99
71763340|NCT02433080|143028500|OTHER||Mean Difference (Net)|6.4||||0.05|TWO_SIDED|95.0|-3.6|16.5|||ANCOVA|||This statistical analysis applies for the outcomes 2-8.||16.5|-3.6|0.05
71763341|NCT00312195|143028511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79|STANDARD_ERROR_OF_MEAN|0.2544||0.0217|TWO_SIDED|95.0|1.09|2.95||P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).|Regression, Logistic||Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.|H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.||2.95|1.09|.0217
71763342|NCT02511106|143028515|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.3|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.30|0.18|<0.0001
71763343|NCT02511106|143028516|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.21|0.34|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.34|0.21|<0.0001
71763344|NCT02511106|143028519|SUPERIORITY||Hazard Ratio (HR)|0.4913||||0.0004|TWO_SIDED|95.03|0.3307|0.7299|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7299|0.3307|0.0004
71763345|NCT02511106|143028520|SUPERIORITY||Hazard Ratio (HR)|0.4912|||<|0.0001|TWO_SIDED|95.03|0.3439|0.7017|||Log Rank|Determined using a log rank test stratified by stage, race and mutation type.|A hazard ratio \<1 favours AZD9291.|||0.7017|0.3439|<0.0001
71763346|NCT01640834|143028610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84||||0.0542|TWO_SIDED|95.0|-11.82|0.14|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||0.14|-11.82|0.0542
71763347|NCT01640834|143028610|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.89||||0.0826|TWO_SIDED|95.0|-14.95|1.16|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.||1.16|-14.95|0.0826
71774913|NCT01051466|143050114|SUPERIORITY_OR_OTHER|||||||0.697||||||The p-value is for Gsα translocation in platelets at Week 8.|Mixed Models Analysis|||||||0.697
71774914|NCT01051466|143050114|SUPERIORITY_OR_OTHER|||||||0.276||||||The p-value is for Gsα translocation in platelets at Week 12.|Mixed Models Analysis|||||||0.276
71774915|NCT01051466|143050116|SUPERIORITY_OR_OTHER|||||||0.904||||||The p-value is for change from baseline BDNF.|Mixed Models Analysis|||||||0.904
71774916|NCT01051466|143050116|SUPERIORITY_OR_OTHER|||||||0.819||||||The p-value is for change from baseline proBDNF.|Mixed Models Analysis|||||||0.819
71774917|NCT01051466|143050117|SUPERIORITY_OR_OTHER|||||||0.273||||||The p-value is for change from baseline trkB.|Mixed Models Analysis|||||||0.273
71774918|NCT01051466|143050118|SUPERIORITY_OR_OTHER|||||||0.797||||||The p-value is for change from baseline cytokine TNFα.|Mixed Models Analysis|||||||0.797
71825518|NCT01101165|143155370|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.8|||||TWO_SIDED|90.0|92.42|97.24|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.24|92.42|
71825519|NCT01101165|143155371|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.5|||||TWO_SIDED|90.0|92.93|98.18|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||98.18|92.93|
71825520|NCT02219490|143155376|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71825521|NCT02219490|143155376|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
71825522|NCT02219490|143155377|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71825523|NCT02219490|143155377|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
71825524|NCT02219490|143155378|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71825525|NCT02219490|143155378|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
71825526|NCT02219490|143155379|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
71825527|NCT02219490|143155379|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
71825528|NCT02219490|143155380|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
71825529|NCT02219490|143155380|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
71825530|NCT02219490|143155381|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71739328|NCT00122369|142991370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71652743|NCT03440424|142823854|OTHER||Percent ratio of geometric mean|125.26|||||TWO_SIDED|90.0|96.76|162.16|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||162.16|96.76|
71774919|NCT01051466|143050118|SUPERIORITY_OR_OTHER|||||||0.269||||||The p-value is for change from baseline cytokine IL-1.|Mixed Models Analysis|||||||0.269
71652744|NCT03440424|142823854|OTHER||Percent ratio of geometric mean|115.2|||||TWO_SIDED|90.0|88.98|149.13|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||149.13|88.98|
71652745|NCT03440424|142823855|OTHER||Percent ratio of geometric mean|131.91|||||TWO_SIDED|90.0|96.46|180.4|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||180.40|96.46|
71652746|NCT03440424|142823855|OTHER||Percent ratio of geometric mean|149.52|||||TWO_SIDED|90.0|109.34|204.47|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||204.47|109.34|
71652747|NCT03440424|142823856|OTHER||Percent ratio of geometric mean|125.03|||||TWO_SIDED|90.0|87.96|177.74|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||177.74|87.96|
71652748|NCT03440424|142823856|OTHER||Percent ratio of geometric mean|153.56|||||TWO_SIDED|90.0|106.39|221.66|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||221.66|106.39|
71652749|NCT03440424|142823857|OTHER||Percent ratio of geometric mean|128.88|||||TWO_SIDED|90.0|88.35|188.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||188.02|88.35|
71652750|NCT03440424|142823857|OTHER||Percent ratio of geometric mean|166.55|||||TWO_SIDED|90.0|112.31|246.99|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|||246.99|112.31|
71652751|NCT03440424|142823858|OTHER||Percent ratio of geometric mean|96.97|||||TWO_SIDED|90.0|70.15|134.06|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||134.06|70.15|
71652752|NCT03440424|142823858|OTHER||Percent ratio of geometric mean|72.05|||||TWO_SIDED|90.0|52.12|99.6|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||99.60|52.12|
71652753|NCT03440424|142823858|OTHER||Percent ratio of geometric mean|84.36|||||TWO_SIDED|90.0|60.21|118.19|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||118.19|60.21|
71652754|NCT03440424|142823858|OTHER||Percent ratio of geometric mean|65.7|||||TWO_SIDED|90.0|46.89|92.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.05|46.89|
71652755|NCT03440424|142823858|OTHER||Percent ratio of geometric mean|94.74|||||TWO_SIDED|90.0|68.37|131.3|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||131.30|68.37|
71652756|NCT03440424|142823858|OTHER||Percent ratio of geometric mean|76.56|||||TWO_SIDED|90.0|55.24|106.09|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||106.09|55.24|
71652757|NCT03440424|142823860|OTHER||Percent ratio of geometric mean|99.14|||||TWO_SIDED|90.0|76.91|127.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||127.81|76.91|
71652758|NCT03440424|142823860|OTHER||Percent ratio of geometric mean|69.66|||||TWO_SIDED|90.0|54.03|89.79|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||89.79|54.03|
71652759|NCT03440424|142823860|OTHER||Percent ratio of geometric mean|78.98|||||TWO_SIDED|90.0|62.88|99.21|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||99.21|62.88|
71652760|NCT03440424|142823860|OTHER||Percent ratio of geometric mean|63.2|||||TWO_SIDED|90.0|50.31|79.38|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||79.38|50.31|
71774920|NCT01051466|143050118|SUPERIORITY_OR_OTHER|||||||0.925||||||The p-value is for change from baseline cytokine IL-6.|Mixed Models Analysis|||||||0.925
71774921|NCT00145600|143050134|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.886|||||TWO_SIDED|95.0|0.82|0.953||||||||0.953|0.820|
71652761|NCT03440424|142823860|OTHER||Percent ratio of geometric mean|94.56|||||TWO_SIDED|90.0|68.5|130.51|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||130.51|68.50|
71652762|NCT03440424|142823860|OTHER||Percent ratio of geometric mean|71.81|||||TWO_SIDED|90.0|52.03|99.12|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||99.12|52.03|
71652763|NCT03440424|142823861|OTHER||Percent ratio of geometric mean|106.7|||||TWO_SIDED|90.0|83.95|135.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||135.62|83.95|
71652764|NCT03440424|142823861|OTHER||Percent ratio of geometric mean|85.68|||||TWO_SIDED|90.0|67.41|108.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||108.90|67.41|
71652765|NCT03440424|142823861|OTHER||Percent ratio of geometric mean|75.41|||||TWO_SIDED|90.0|62.28|91.31|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||91.31|62.28|
71652766|NCT03440424|142823861|OTHER||Percent ratio of geometric mean|76.0|||||TWO_SIDED|90.0|62.76|92.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||92.02|62.76|
71738857|NCT02106403|142990600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02||||0.503|TWO_SIDED|95.0|-3.95|8.0|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||8.00|-3.95|0.5030
71738858|NCT02106403|142990600|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.1482|TWO_SIDED|95.0|-1.59|10.36|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.||10.36|-1.59|0.1482
71739329|NCT00122369|142991370|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Ordinal regression|||||||<0.001
71886535|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.1|=|0.6053|TWO_SIDED|95.0|-2.7|1.6|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||1.6|-2.7|=0.6053
71652767|NCT03440424|142823861|OTHER||Percent ratio of geometric mean|95.55|||||TWO_SIDED|90.0|71.92|126.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||126.94|71.92|
71652768|NCT03440424|142823861|OTHER||Percent ratio of geometric mean|74.48|||||TWO_SIDED|90.0|56.06|98.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||98.94|56.06|
71652769|NCT03440424|142823862|OTHER||Percent ratio of geometric mean|113.04|||||TWO_SIDED|90.0|85.16|150.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||150.05|85.16|
71652770|NCT03440424|142823862|OTHER||Percent ratio of geometric mean|103.74|||||TWO_SIDED|90.0|78.16|137.7|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||137.70|78.16|
71652771|NCT03440424|142823862|OTHER||Percent ratio of geometric mean|78.62|||||TWO_SIDED|90.0|62.57|98.78|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||98.78|62.57|
71652772|NCT03440424|142823862|OTHER||Percent ratio of geometric mean|101.0|||||TWO_SIDED|90.0|80.38|126.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||126.90|80.38|
71652773|NCT03440424|142823862|OTHER||Percent ratio of geometric mean|109.49|||||TWO_SIDED|90.0|81.07|147.88|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||147.88|81.07|
71652774|NCT03440424|142823862|OTHER||Percent ratio of geometric mean|105.2|||||TWO_SIDED|90.0|77.89|142.08|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.08|77.89|
71652775|NCT03440424|142823863|OTHER||Percent ratio of geometric mean|115.38|||||TWO_SIDED|90.0|83.51|159.42|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||159.42|83.51|
71652776|NCT03440424|142823863|OTHER||Percent ratio of geometric mean|116.97|||||TWO_SIDED|90.0|84.66|161.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite||161.62|84.66|
71652777|NCT03440424|142823863|OTHER||Percent ratio of geometric mean|78.46|||||TWO_SIDED|90.0|61.06|100.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||100.81|61.06|
71652778|NCT03440424|142823863|OTHER||Percent ratio of geometric mean|116.76|||||TWO_SIDED|90.0|89.95|151.56|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite||151.56|89.95|
71652779|NCT03440424|142823863|OTHER||Percent ratio of geometric mean|94.97|||||TWO_SIDED|90.0|70.31|128.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||128.28|70.31|
71652780|NCT03440424|142823863|OTHER||Percent ratio of geometric mean|103.59|||||TWO_SIDED|90.0|75.43|142.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite||142.28|75.43|
71652781|NCT03702049|142823871|OTHER|Change in score at 3 months|Mean Difference (Final Values)|-0.24||||0.603|TWO_SIDED||||||Mixed Models Analysis|||Change in score at 3 months||||0.603
71652782|NCT03702049|142823871|OTHER|Change at 6 months|Mean Difference (Final Values)|-0.12||||0.805|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.805
71652783|NCT03702049|142823872|OTHER||Odds Ratio (OR)|0.83||||0.672|TWO_SIDED|95.0|0.39|1.79|||Regression, Logistic|||3 month outcome||1.79|0.39|0.672
71652784|NCT03702049|142823872|OTHER||Odds Ratio (OR)|0.49||||0.165|TWO_SIDED|95.0|0.18|1.34|||Regression, Logistic|||6 month outcome||1.34|0.18|0.165
71652785|NCT03702049|142823873|OTHER||Mean Difference (Final Values)|-0.31||||0.719|TWO_SIDED||||||Mixed Models Analysis|||3 month outcome||||0.719
71652786|NCT03702049|142823873|OTHER||Mean Difference (Final Values)|0.43||||0.626|TWO_SIDED||||||Mixed Models Analysis|||6 month outcome||||0.626
71652787|NCT03702049|142823874|OTHER||Mean Difference (Final Values)|0.83||||0.1668|TWO_SIDED|95.0|-0.36|2.03|||t-test, 2 sided|||||2.03|-0.36|0.1668
71652788|NCT03702049|142823875|OTHER||Mean Difference (Final Values)|1.5||||0.9198|TWO_SIDED|95.0|-29.6|32.7|||t-test, 2 sided|||3 month outcome||32.7|-29.6|0.9198
71652789|NCT03702049|142823875|OTHER||Mean Difference (Final Values)|12.5||||0.5015|TWO_SIDED|95.0|-25.6|50.7|||t-test, 2 sided|||6 month||50.7|-25.6|0.5015
71886536|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.54|=|0.8149|TWO_SIDED|95.0|-3.4|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||2.7|-3.4|=0.8149
71704476|NCT02421510|142926906|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.025|TWO_SIDED|95.0|-0.6|0.0||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||0|-0.6|0.025
71704477|NCT02421510|142926906|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2||Threshold for significance \<= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (\<=8.5%, \>8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.||-0.2|-0.7|0.003
71704478|NCT03338023|142926941|NON_INFERIORITY|Noninferiority of LY2963016 to Lantus® was demonstrated at the 0.4% noninferiority margin and over 80 percent power.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
71704479|NCT03338023|142926942|NON_INFERIORITY|Noninferiority of Lantus® to LY2963016 was demonstrated at the 0.4% noninferiority margin.|Mean Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.32|0.08||||||||0.08|-0.32|
71704480|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-6.8||||0.191|TWO_SIDED|95.0|-17.0|3.4|||Mixed Models Analysis|||Before Morning Meal Glucose||3.4|-17.0|0.191
71704481|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-7.8||||0.25|TWO_SIDED|95.0|-21.2|5.5|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||5.5|-21.2|0.250
71704482|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-13.1||||0.028|TWO_SIDED|95.0|-24.7|-1.5|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||-1.5|-24.7|0.028
71704483|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-3.6||||0.599|TWO_SIDED|95.0|-16.8|9.7|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||9.7|-16.8|0.599
71704484|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-11.0||||0.109|TWO_SIDED|95.0|-24.4|2.5|||Mixed Models Analysis|||Before Evening Meal Glucose||2.5|-24.4|0.109
71774922|NCT00145600|143050134|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
71704485|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-5.4||||0.452|TWO_SIDED|95.0|-19.4|8.6|||Mixed Models Analysis|||Bedtime Glucose||8.6|-19.4|0.452
71704486|NCT03338023|142926943|SUPERIORITY||Mean Difference (Net)|-7.4||||0.18|TWO_SIDED|95.0|-18.3|3.5|||Mixed Models Analysis|||0300 Am Glucose||3.5|-18.3|0.180
71704487|NCT03338023|142926944|SUPERIORITY|||||||0.787|||||||Fisher Exact|||||||0.787
71704488|NCT03338023|142926945|SUPERIORITY|||||||0.201|||||||Fisher Exact|||||||0.201
71704489|NCT03338023|142926946|SUPERIORITY||Mean Difference (Net)|-0.3||||0.885|TWO_SIDED|95.0|-0.4|3.4|||Mixed Models Analysis|||||3.4|-0.4|0.885
71704490|NCT03338023|142926947|SUPERIORITY||Mean Difference (Net)|-3.5||||0.328|TWO_SIDED|95.0|-10.6|3.6|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||3.6|-10.6|0.328
71704491|NCT03338023|142926947|SUPERIORITY||Mean Difference (Net)|-1.7||||0.467|TWO_SIDED|95.0|-6.5|3.0|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.0|-6.5|0.467
71704492|NCT03338023|142926948|SUPERIORITY||Mean Difference (Net)|-0.8||||0.09|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.090
71704493|NCT03338023|142926949|SUPERIORITY||Mean Difference (Net)|-1.2||||0.089|TWO_SIDED|95.0|-2.6|0.2|||Mixed Models Analysis|||||0.2|-2.6|0.089
71704494|NCT03338023|142926950|SUPERIORITY||Mean Difference (Net)|-0.1||||0.77|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.770
71704495|NCT03338023|142926951|SUPERIORITY||Mean Difference (Net)|-0.3||||0.879|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||ITSQ Inconvenience of Regimen Transformed Score||3.3|-3.9|0.879
71704496|NCT03338023|142926951|SUPERIORITY||Mean Difference (Net)|-0.7||||0.788|TWO_SIDED|95.0|-5.9|4.5|||ANCOVA|||ITSQ Lifestyle Flexibility Transformed Score||4.5|-5.9|0.788
71704497|NCT03338023|142926951|SUPERIORITY||Mean Difference (Net)|-0.6||||0.775|TWO_SIDED|95.0|-4.5|3.3|||ANCOVA|||ITSQ Hypoglycemic Control Transformed Score||3.3|-4.5|0.775
71704498|NCT03338023|142926951|SUPERIORITY||Mean Difference (Net)|1.0||||0.681|TWO_SIDED|95.0|-3.6|5.6|||ANCOVA|||ITSQ Glycemic Control Transformed Score||5.6|-3.6|0.681
71704499|NCT03338023|142926951|SUPERIORITY||Mean Difference (Net)|0.4||||0.819|TWO_SIDED|95.0|-3.1|3.9|||ANCOVA|||ITSQ Insulin Delivery Device Satisfaction Transformed Score||3.9|-3.1|0.819
71704500|NCT03338023|142926951|SUPERIORITY||Mean Difference (Net)|-0.8||||0.605|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|||ITSQ Total Transformed Score||2.3|-3.9|0.605
71704501|NCT05061706|142926980|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-6.03|-3.02|||Mixed Effects Model for Repeated Measure|||||-3.02|-6.03|<0.0001
71704502|NCT05061706|142926981|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.33|||Mixed Effects Model for Repeated Measure|||||-0.33|-0.72|<0.0001
71774923|NCT00145600|143050134|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
71774924|NCT00145600|143050134|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.793|||||TWO_SIDED|95.0|0.726|0.86||||||||0.860|0.726|
71774925|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0|||||Wilcoxon signed rank test|||||||0.3097
71652790|NCT01833533|142823876|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
71652791|NCT01833533|142823876|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
71652792|NCT01833533|142823877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71652793|NCT01833533|142823878|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.0|||||TWO_SIDED|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|93.7|
71652794|NCT01833533|142823878|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.2|||||TWO_SIDED|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||94.3|86.2|
71652795|NCT01833533|142823878|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|-6.8|||||TWO_SIDED|95.0|-12.0|-1.5|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \>95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).||-1.5|-12.0|
71652796|NCT01138826|142823883|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|105.57|||||TWO_SIDED|90.0|98.09|113.61||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||113.61|98.09|
71652797|NCT01138826|142823883|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|107.55|||||TWO_SIDED|90.0|99.98|115.69||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||115.69|99.98|
71704503|NCT02864914|142927053|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.5|1.19|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.19|0.50|
71704504|NCT02864914|142927053|OTHER||Adjusted incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.23|1.32|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.32|0.23|
71704505|NCT02864914|142927053|OTHER||Adjusted incidence rate ratio|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.41|0.52|
71886537|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.55|=|0.9058|TWO_SIDED|95.0|-3.2|2.9|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||2.9|-3.2|=0.9058
71652798|NCT01138826|142823883|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|101.88|||||TWO_SIDED|90.0|94.7|109.6||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||109.60|94.70|
71738859|NCT04146935|142990602|OTHER|Mixed model repeated measures||||||0.4147||||||Visit 1 (baseline) to visit 4 (peak)|Mixed Models Analysis|||||||0.4147
71738860|NCT04146935|142990603|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71738861|NCT04146935|142990604|OTHER|Mixed model repeated measures||||||0.6957|||||||Mixed Models Analysis|||||||0.6957
71738862|NCT04146935|142990605|OTHER|||||||0.0092|||||||Mixed Models Analysis|||||||0.0092
71738863|NCT04146935|142990606|OTHER|Mixed model repeated measures||||||0.1383|||||||Mixed Models Analysis|||||||0.1383
71738864|NCT04146935|142990607|OTHER|mixed model repeated measures||||||0.0572|||||||Mixed Models Analysis|||||||0.0572
71738865|NCT04038567|142990608|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-1.14|1.2||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.20|-1.14|
71738866|NCT04038567|142990608|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.39|-0.04||||||Values are change in model-estimated means for his vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.04|-2.39|
71738867|NCT04038567|142990608|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-1.12|1.23||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.23|-1.12|
71738868|NCT04038567|142990609|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|95.0|-2.12|-0.16||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.16|-2.12|
71738869|NCT04038567|142990609|SUPERIORITY||Mean Difference (Final Values)|-0.82|||||TWO_SIDED|95.0|-1.8|1.49||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-1.80|
71738870|NCT04038567|142990609|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.48|1.49||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.49|-0.48|
71738871|NCT04038567|142990610|SUPERIORITY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-1.66|1.01||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.01|-1.66|
71738872|NCT04038567|142990610|SUPERIORITY||Mean Difference (Final Values)|-1.47|||||TWO_SIDED|95.0|-2.81|-0.14||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.14|-2.81|
71739330|NCT00122369|142991370|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Proportional odds model|||||||0.024
71825531|NCT02219490|143155381|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
71825532|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.7||0.151|TWO_SIDED|95.0|-0.37|2.37|||ANCOVA||Difference = with SVR12 minus without SVR12|"Final Treatment Visit~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||2.37|-0.37|0.151
71652799|NCT01138826|142823884|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|103.88|||||TWO_SIDED|90.0|97.27|110.94||||||||110.94|97.27|
71652800|NCT01138826|142823884|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|104.26|||||TWO_SIDED|90.0|97.67|111.3||||||||111.30|97.67|
71652801|NCT01138826|142823884|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|100.37|||||TWO_SIDED|90.0|94.02|107.15||||||||107.15|94.02|
71652802|NCT01138826|142823885|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|98.39|||||TWO_SIDED|90.0|91.05|106.33||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||106.33|91.05|
71652803|NCT01138826|142823885|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|95.22|||||TWO_SIDED|90.0|88.16|102.84||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||102.84|88.16|
71652804|NCT01138826|142823885|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|96.77|||||TWO_SIDED|90.0|89.58|104.54||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||104.54|89.58|
71652805|NCT03360916|142823901|SUPERIORITY||Mean Difference (Net)|2.29|STANDARD_DEVIATION|125.59||0.953|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.9530
71652806|NCT03360916|142823901|SUPERIORITY||Mean Difference (Net)|-11.24|STANDARD_DEVIATION|130.12||0.7908|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.7908
71652807|NCT03360916|142823901|SUPERIORITY||Mean Difference (Net)|44.88|STANDARD_DEVIATION|105.19||0.1344|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.1344
71652808|NCT03360916|142823902|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.18||0.0005|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0005
71652809|NCT03360916|142823902|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.21||0.0021|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0021
71652810|NCT03360916|142823902|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.23||0.0025|TWO_SIDED||||||t-test, 2 sided|This is within group 3 month change||||||0.0025
71738873|NCT04038567|142990610|SUPERIORITY||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-0.52|2.15||||||Values are change in model-estimated means for therapist vs. app response to symptoms. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.15|-0.52|
71825533|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.78||0.878|TWO_SIDED|95.0|-1.64|1.4|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 12~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.4|-1.64|0.878
71825534|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.72|=|0.199|TWO_SIDED|95.0|-2.33|0.48|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 24~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.48|-2.33|=0.199
71825535|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.93||0.021|TWO_SIDED|95.0|-4.0|-0.33|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 52~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.33|-4|0.021
71825536|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.89||0.006|TWO_SIDED|95.0|-4.22|-0.71|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 104~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.71|-4.22|0.006
71652811|NCT00619359|142823919|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.|Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|3.7||||95.0|-4.1|3.3||||||||3.3|-4.1|
71652812|NCT00619359|142823920|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.|Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-3.5|3.7||||||||3.7|-3.5|
71652813|NCT00619359|142823921|NON_INFERIORITY_OR_EQUIVALENCE|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.|Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.6||||95.0|-5.3|2.0||||||||2.0|-5.3|
71652814|NCT02502734|142823922|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|Mean Difference (Final Values)|-0.052|||||TWO_SIDED|95.0|-0.1217|0.0176||Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025,1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|ANCOVA|Analysis performed using ANCOVA with covariates period-level baseline and subject-level baseline lower-leg length, age, gender, treatment and period.||||0.0176|-0.1217|
71704506|NCT02864914|142927054|OTHER||Adjusted incidence rate ratio|0.54|||||TWO_SIDED|95.0|0.41|0.73|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.73|0.41|
71704507|NCT02864914|142927054|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.3|0.55|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.55|0.30|
71704508|NCT02864914|142927054|OTHER||Adjusted incidence rate ratio|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.05|0.45|
71704509|NCT02864914|142927054|OTHER||Adjusted incidence rate ratio|0.41|||||TWO_SIDED|95.0|0.2|0.86|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.86|0.20|
71704510|NCT02864914|142927054|OTHER||Adjusted incidence rate ratio|0.65|||||TWO_SIDED|95.0|0.56|0.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.76|0.56|
71738874|NCT04038567|142990611|SUPERIORITY||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-1.23|0.91||||||||0.91|-1.23|
71738875|NCT04038567|142990611|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|95.0|-2.29|-0.15||||||||-0.15|-2.29|
71738876|NCT04038567|142990611|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.77|0.37||||||||0.37|-1.77|
71704511|NCT02864914|142927055|OTHER||Adjusted incidence rate ratio|2.19|||||TWO_SIDED|95.0|1.74|2.76|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.76|1.74|
71704512|NCT02864914|142927055|OTHER||Adjusted incidence rate ratio|2.78|||||TWO_SIDED|95.0|1.77|4.36|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.36|1.77|
71704513|NCT02864914|142927055|OTHER||Adjusted incidence rate ratio|2.14|||||TWO_SIDED|95.0|1.11|4.12|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.12|1.11|
71704514|NCT02864914|142927055|OTHER||Adjusted incidence rate ratio|1.99|||||TWO_SIDED|95.0|1.48|2.66|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||2.66|1.48|
71704515|NCT02864914|142927056|OTHER||Adjusted incidence rate ratio|0.51|||||TWO_SIDED|95.0|0.37|0.72|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.72|0.37|
71704516|NCT02864914|142927057|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.46|4.71|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.71|3.46|
71704517|NCT02864914|142927058|OTHER||Adjusted incidence rate ratio|3.24|||||TWO_SIDED|95.0|2.81|3.74|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.74|2.81|
71704518|NCT02864914|142927059|OTHER||Adjusted incidence rate ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.88|0.56|
71704519|NCT02864914|142927059|OTHER||Adjusted incidence rate ratio|0.5|||||TWO_SIDED|95.0|0.29|0.85|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.85|0.29|
71704520|NCT02864914|142927059|OTHER||Adjusted incidence rate ratio|0.66|||||TWO_SIDED|95.0|0.34|1.29|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||1.29|0.34|
71739331|NCT00122369|142991370|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Proportional odds model|||||||0.018
71739332|NCT00122369|142991370|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Proportional odds model|||||||0.73
71825537|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-2.58|STANDARD_ERROR_OF_MEAN|0.92||0.005|TWO_SIDED|95.0|-4.38|-0.79|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 156~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||-0.79|-4.38|0.005
71825538|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.0||0.172|TWO_SIDED|95.0|-3.32|0.59|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 208~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||0.59|-3.32|0.172
71652815|NCT00508027|142823958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|1.7|<|0.05|||||||t-test, 2 sided|||Ho: There is no change in plasma biomarker levels before and after simivastatin treatment. With 12 patients in each group and assuming a 5% risk of Type I error (two-tailed α = 0.05) and estimated SD for the change in NOx (or sVCAM-1) of 48%, power will be 80% to detect a 40% change from baseline for each group, and a 55% difference in the change in biomarker levels between dose groups. Matched paired t-tests were used to measure changes in biomarker levels from baseline.||||<0.05
71652816|NCT00562120|142824009|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED|||||P-value was based on one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.302
71652817|NCT00562120|142824009|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
71652818|NCT00562120|142824009|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.229
71652819|NCT00562120|142824009|SUPERIORITY_OR_OTHER|||||||0.544|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.544
71652820|NCT00562120|142824009|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.710
71652821|NCT00562120|142824009|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.816
71652822|NCT00562120|142824010|SUPERIORITY_OR_OTHER|||||||0.269|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.269
71652823|NCT00562120|142824010|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.097
71652824|NCT00562120|142824010|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.252
71652825|NCT00562120|142824010|SUPERIORITY_OR_OTHER|||||||0.479|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.479
71652826|NCT00562120|142824010|SUPERIORITY_OR_OTHER|||||||0.521|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.521
71652827|NCT00562120|142824010|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
71652828|NCT00562120|142824011|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.130
71652829|NCT00562120|142824011|SUPERIORITY_OR_OTHER|||||||0.663|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.663
71652830|NCT00562120|142824011|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.138
71652831|NCT00562120|142824011|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.124
71738877|NCT04038567|142990612|SUPERIORITY||Mean Difference (Final Values)|-1.58|||||TWO_SIDED|95.0|-4.41|1.25||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.25|-4.41|
71739333|NCT04254666|142991387|OTHER||||||||||||||||||pre and post scores for this measure are presented as the percent of foods correctly classified.|||
71652832|NCT00562120|142824011|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.134
71652833|NCT00562120|142824011|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.978
71652834|NCT00562120|142824012|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.357
71652835|NCT00562120|142824012|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.952
71652836|NCT00562120|142824012|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.480
71652837|NCT00562120|142824012|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.043
71652838|NCT00562120|142824012|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.087
71652839|NCT00562120|142824012|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.753
71652840|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.011
71652841|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.127
71652842|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.103
71652843|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.218
71652844|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.905
71652845|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.273
71652846|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71704521|NCT02864914|142927059|OTHER||Adjusted incidence rate ratio|0.77|||||TWO_SIDED|95.0|0.61|0.97|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.97|0.61|
71704522|NCT02864914|142927060|OTHER||Adjusted incidence rate ratio|0.53|||||TWO_SIDED|95.0|0.43|0.65|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||0.65|0.43|
71739334|NCT00826618|142991469|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||Compare final visual acuity to baseline visual acuity||||0.0015
71739335|NCT05224453|142991514|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-5.0|||<|0.05|TWO_SIDED|95.0|-6.21|-3.78|||t-test, 2 sided|||||-3.78|-6.21|<0.05
71825539|NCT02219490|143155382|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.14||0.322|TWO_SIDED|95.0|-3.35|1.1|||ANCOVA||Difference = with SVR12 minus without SVR12|"Post-Treatment Week 260~The effect of sustained virologic response on change from baseline in FibroScan score was evaluated by comparing mean change from baseline between subjects who achieved SVR12 and those who did not using ANCOVA analyses. SVR12 status was included as a factor and baseline FibroScan score was included as a covariate in the ANCOVA model."||1.1|-3.35|0.322
71825540|NCT03879642|143155402|SUPERIORITY||partial eta squared|0.117|||||TWO_SIDED||||||ANOVA|||||||
71825541|NCT03879642|143155403|SUPERIORITY||partial eta squared|0.005|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71825542|NCT00567164|143155417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.85|STANDARD_DEVIATION|30.356||0.0001||95.0|-16.3|-7.394|||t-test, 2 sided|||||-7.394|-16.3|0.0001
71825543|NCT01859312|143155468|OTHER|||||||0.021|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.021
71704523|NCT02864914|142927061|OTHER||Adjusted incidence rate ratio|4.04|||||TWO_SIDED|95.0|3.44|4.75|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||4.75|3.44|
71738878|NCT04038567|142990612|SUPERIORITY||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-3.26|2.42||||||Values are change in model-estimated means for hig vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.42|-3.26|
71738879|NCT04038567|142990612|SUPERIORITY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-1.35|4.33||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||4.33|-1.35|
71738880|NCT04038567|142990617|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-0.62|1.78||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.78|-0.62|
71738881|NCT04038567|142990617|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-0.47|1.92||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.92|-0.47|
71738882|NCT04038567|142990617|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.0|1.39||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.39|-1.00|
71738883|NCT04038567|142990618|SUPERIORITY||Mean Difference (Final Values)|0.91|||||TWO_SIDED|95.0|-0.45|2.27||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||2.27|-0.45|
71738884|NCT04038567|142990618|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-1.33|1.38||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.38|-1.33|
71738885|NCT04038567|142990618|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.72|0.99||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.99|-1.72|
71738886|NCT04038567|142990619|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.3|0.3||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.30|-1.30|
71738887|NCT04038567|142990619|SUPERIORITY||Mean Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-1.33|0.27||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.27|-1.33|
71738888|NCT04038567|142990619|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.55|1.05||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.05|-.55|
71738889|NCT04038567|142990620|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.41|0.41||||||||0.41|-1.41|
71738890|NCT04038567|142990620|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.27|0.55||||||||0.55|-1.27|
71738891|NCT04038567|142990620|SUPERIORITY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.42|-0.40|
71738892|NCT04038567|142990621|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|-3.25|7.91||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.91|-3.25|
71739336|NCT05224453|142991515|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-3.7|||<|0.05|TWO_SIDED|95.0|-6.53|-0.86|||t-test, 2 sided|||||-0.86|-6.53|<0.05
71763348|NCT01640834|143028611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.046|TWO_SIDED|95.0|-33.7|-0.4|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.||-0.4|-33.7|0.0460
71763349|NCT01640834|143028611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6||||0.0192|TWO_SIDED|95.0|-35.0|-4.3|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.||-4.3|-35.0|0.0192
71763350|NCT01640834|143028616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.0||||0.0187|TWO_SIDED|95.0|-82.0|-9.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-9|-82|0.0187
71763351|NCT01640834|143028616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.0||||0.0048|TWO_SIDED|95.0|-96.0|-23.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).||-23|-96|0.0048
71763352|NCT01640834|143028617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4423.0||||0.0278|TWO_SIDED|95.0|-8256.0|-590.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-590|-8256|0.0278
71763353|NCT01640834|143028617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5187.0||||0.0046|TWO_SIDED|95.0|-8371.0|-2004.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).||-2004|-8371|0.0046
71763354|NCT04530136|143028618|SUPERIORITY|||||||0.0346|||||||Wilcoxon rank test|||||||0.0346
71763355|NCT04530136|143028619|SUPERIORITY|||||||0.4441|||||||WHO Ordinal Scale|||||||0.4441
71763356|NCT04530136|143028620|SUPERIORITY|||||||0.1021|||||||WHO Ordinal Scale for Clin Improvement|||||||0.1021
71763357|NCT04530136|143028621|SUPERIORITY|||||||0.1615|||||||WHO Ordinal Scale|||||||0.1615
71763358|NCT01309282|143028622|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
71763359|NCT01309282|143028623|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0078
71763360|NCT01309282|143028624|SUPERIORITY_OR_OTHER|||||||0.01403|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.01403
71763361|NCT01309282|143028625|SUPERIORITY_OR_OTHER|||||||0.0355|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0355
71763362|NCT01309282|143028626|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.5469
71763363|NCT01309282|143028627|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
71763364|NCT01309282|143028628|SUPERIORITY_OR_OTHER|||||||0.0225|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0225
71763365|NCT01309282|143028629|SUPERIORITY_OR_OTHER|||||||0.0904|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.0904
71763366|NCT01309282|143028630|SUPERIORITY_OR_OTHER|||||||0.2969|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2969
71763367|NCT01387542|143028636|SUPERIORITY_OR_OTHER|||||||0|||||||Friedman test|||||||0.000
71763368|NCT01387542|143028637|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||||||0.009
71763369|NCT01387542|143028638|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||||||0.001
71763370|NCT01387542|143028639|SUPERIORITY_OR_OTHER|||||||0|||||||Paired t-test|||||||0.000
71763371|NCT03601117|143028644|OTHER|This is to test for the antidepressant effect of LDLPFC stimulation. Test is change in score from baseline to approximately 48 hours after the final session.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
71763372|NCT00884741|143028674|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.11|TWO_SIDED|95.0|0.93|1.37||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||1.37|0.93|0.11
71763373|NCT00884741|143028675|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.79||||0.004|TWO_SIDED|95.0|0.66|0.94||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).||0.94|0.66|0.004
71763374|NCT00884741|143028676|SUPERIORITY_OR_OTHER|||||||0.42||||||Two-sided|Chi-squared|||||||0.42
71763375|NCT02762370|143028696|SUPERIORITY|||||||0.0452|||||||t-test, 2 sided|||||||0.0452
71763376|NCT00101452|143028708|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71774926|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774927|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71763377|NCT05661851|143028711|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Least-square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-1.67|13.38|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control.|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||13.38|-1.67|
71652847|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.055|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.055
71652848|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.012
71652849|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.048
71652850|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.496|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.496
71739337|NCT05224453|142991515|SUPERIORITY|Parametric t test|Mean Difference (Final Values)|-1.7|||<|0.05|TWO_SIDED|95.0|-3.84|0.44|||t-test, 2 sided|||||0.44|-3.84|<0.05
71739338|NCT01128244|142991518|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|||||Threshold for significance P\<0.05|t-test, 2 sided|Paired t-test||||||0.20
71739339|NCT01128244|142991519|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.62
71739340|NCT01128244|142991520|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||<0.001
71739341|NCT01128244|142991521|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||Threshold for significance, P\<0.05|t-test, 2 sided|Paired t-test||||||0.45
71739342|NCT01128244|142991522|SUPERIORITY_OR_OTHER||Test of treatment effect.|0.05|||<|0.05|TWO_SIDED|||||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|t-test, 2 sided|||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.||||<0.05
71739343|NCT02219334|142991523|EQUIVALENCE|Historical data at the institution for similar patients had a mean length of stay(LOS) of 25.7 hours (standard deviation-\[SD\] =10.3) from 9/2012- 9/13 was observed for 134 patients admitted to the emergency department observation unit and treated with the standard of care (NeoSucker). Given a LOS-SD of 10.3 hours, 75 subjects per treatment group would provide 80% statistical power at the 5% significance level to demonstrate equivalence in the two treatments' length of stay within ±5 hours.|Mean Difference (Final Values)|2.49|STANDARD_DEVIATION|21.4|<|0.05|TWO_SIDED|95.0|-10.74|15.72|||two one-sided t-test (TOST)||Due to slower than anticipated patient recruitment, the target size of 75 participants per treatment group was not reached.|The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.||15.72|-10.74|<0.05
71739344|NCT06292130|142991540|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71739345|NCT06292130|142991541|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71739346|NCT02381015|142991566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
71739347|NCT02381015|142991567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||Chi-squared|||||||0.35
71739348|NCT02381015|142991568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|||||||0.29
71739349|NCT02381015|142991569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Kruskal-Wallis|||||||0.49
71739350|NCT02381015|142991570|OTHER||Beta|93.5|STANDARD_ERROR_OF_MEAN|1.55||0.42|TWO_SIDED||||||ANOVA|||The statistical analysis shows the relation between risk given and risk recall at the immediate post results assessment for the total number of participants.||||0.42
71739351|NCT02381015|142991571|OTHER||Beta|94.7|STANDARD_ERROR_OF_MEAN|2.93||0.33|TWO_SIDED||||||ANOVA|||||||0.33
71739352|NCT01934010|142991577|SUPERIORITY|||||||0.128|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 2 treatment cycles.||||0.128
71739353|NCT01934010|142991577|SUPERIORITY|||||||0.075|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 3 treatment cycles.||||0.075
71739354|NCT01934010|142991577|SUPERIORITY|||||||1|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 2 treatment cycles with AM-101 or others who received 3 treatment cycles.||||1
71739355|NCT01934010|142991578|SUPERIORITY|||||||0.4403|||||||Fisher Exact|||||||0.4403
71739356|NCT01934010|142991580|SUPERIORITY|||||||0.2401|||||||Fisher Exact|||||||0.2401
71739357|NCT01934010|142991580|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||||||0.0022
71739358|NCT01934010|142991580|SUPERIORITY|||||||0.1001|||||||Fisher Exact|||||||0.1001
71739359|NCT01934010|142991581|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71739360|NCT01393821|142991583|SUPERIORITY|||||||0.6311|||||||Kruskal-Wallis|||||||0.6311
71739361|NCT01835158|142991602|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.012|TWO_SIDED|95.0|0.46|0.95|||Log Rank|||||.95|.46|0.012
71739362|NCT01835158|142991603|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.26||||||||1.26|0.50|
71739363|NCT00475904|142991605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.547|STANDARD_ERROR_OF_MEAN|0.2709||0.0441|TWO_SIDED|95.0|0.01|1.08||a priori threshold for statistical significance was p\<0.05|ANOVA|||In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.||1.08|0.01|0.0441
71652851|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.190
71652852|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71652853|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.019
71763378|NCT05661851|143028712|NON_INFERIORITY|Non-inferiority margin of -20 was used.|Mean Population Difference Estimate|5.843|STANDARD_ERROR_OF_MEAN|4.456|||TWO_SIDED|95.0|-2.8904|14.5768|||Bootstrapping methods||Bootstrap Mean Difference was calculated as Test minus Control|A sample size of 104 subjects provides at least 90% statistical power to test non-inferiority of the Test eyedrop compared to the Control eyedrop using a two sample t-test with a two-sided type I error rate of 0.05.||14.5768|-2.8904|
71652854|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.009
71652855|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.061
71652856|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.778|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.778
71652857|NCT00562120|142824013|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.102
71652858|NCT00562120|142824014|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71652859|NCT00562120|142824014|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71652860|NCT00562120|142824014|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.000
71652861|NCT00562120|142824014|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.217
71652862|NCT00562120|142824014|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.156
71652863|NCT00562120|142824014|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED|||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||||0.848
71652864|NCT04184999|142824016|SUPERIORITY||F-Statistic|207.4|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
71652865|NCT00545688|142824017|SUPERIORITY_OR_OTHER||Difference in Response rates|16.82||||0.0094|TWO_SIDED|95.0|3.5|30.1||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||30.1|3.5|0.0094
71652866|NCT00545688|142824017|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0141
71652867|NCT00545688|142824017|SUPERIORITY_OR_OTHER||Difference in Response rates|-12.15||||0.0198|TWO_SIDED|95.0|-23.8|-0.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-0.5|-23.8|0.0198
71652868|NCT00545688|142824017|SUPERIORITY_OR_OTHER|||||||0.0198|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0198
71652869|NCT00545688|142824017|SUPERIORITY_OR_OTHER||Difference in Response rates|-21.84||||0.001|TWO_SIDED|95.0|-35.1|-8.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel|||||-8.5|-35.1|0.0010
71652870|NCT00545688|142824017|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel|||||||0.0030
71652871|NCT00545688|142824032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.2983|TWO_SIDED|95.0|0.34|1.4|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||1.40|0.34|0.2983
71774928|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71763379|NCT01014910|143028713|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.|Wilcoxon (Mann-Whitney)|Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)||Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||<0.05
71652872|NCT00545688|142824032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4722|TWO_SIDED|95.0|0.68|2.3|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||2.30|0.68|0.4722
71652873|NCT00545688|142824032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.05||||0.0268|TWO_SIDED|95.0|1.07|3.93|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS||3.93|1.07|0.0268
71774929|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774930|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774931|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197||95.0|||||Wilcoxon signed rank test|||||||0.0197
71652874|NCT00545688|142824032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1805|TWO_SIDED|95.0|0.28|1.27|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.27|0.28|0.1805
71774932|NCT00145600|143050135|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774933|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774934|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774935|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
71774936|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774937|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774938|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774939|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3624||95.0|||||Wilcoxon signed rank test|||||||0.3624
71652875|NCT00545688|142824032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5901|TWO_SIDED|95.0|0.42|1.64|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||1.64|0.42|0.5901
71652876|NCT00545688|142824032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.025|TWO_SIDED|95.0|1.08|4.32|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS||4.32|1.08|0.0250
71652877|NCT00595335|142824055|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||Comparison of the change between the two groups' CAS score at 6 months.||||0.73
71652878|NCT00595335|142824056|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 6 months.||||0.75
71774940|NCT00145600|143050136|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774941|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254||95.0|||||Wilcoxon signed rank test|||||||0.0254
71774942|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.44|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774943|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon signed rank test|||||||0.0004
71774944|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.32||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
71774945|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Correlation Coefficients|||||||<0.0001
71774946|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774947|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
71774948|NCT00145600|143050137|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0061||95.0|||||Spearman Correlation Coefficients|||||||0.0061
71774949|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0687||95.0|||||Wilcoxon signed rank test|||||||0.0687
71774950|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.65|||<|0.0001||95.0|||||Spearman Correlation Coefficient|||||||<0.0001
71774951|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9478||95.0|||||Wilcoxon signed rank test|||||||0.9478
71774952|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774953|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2999||95.0|||||Wilcoxon signed rank test|||||||0.2999
71774954|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774955|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3121||95.0|||||Wilcoxon signed rank test|||||||0.3121
71774956|NCT00145600|143050138|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774957|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
71774958|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.57|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774959|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0282||95.0|||||Wilcoxon signed rank test|||||||0.0282
71774960|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.35||||0.0002||95.0|||||Spearman Correlation Coefficients|||||||0.0002
71652879|NCT00595335|142824056|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
71652880|NCT00595335|142824058|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Comparison of the change between the two groups in proptosis in the right eye at 12 months.||||0.97
71652881|NCT00595335|142824058|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||Comparison of the change between the two groups in change in proptosis in left eye at 12 months.||||0.86
71652882|NCT00595335|142824059|SUPERIORITY_OR_OTHER|||||||0.98|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the right eye between the two groups.||||0.98
71704524|NCT02864914|142927062|OTHER||Adjusted incidence rate ratio|3.34|||||TWO_SIDED|95.0|2.83|3.95|||||Adjusted incidence rate ratio = incidence rate empagliflozin / incidence rate DPP-4 inhibitors|Adjusted IR ratio was generated overall with corresponding 95% CIs through the application of a Poisson regression model where the outcome was modelled as a function of treatment cohort (empagliflozin or DPP-4 inhibitors) and propensity score decile (specified as a categorical variable) with the log of time of exposure (in years) as the offset. If any variable remained unbalanced after trimming, it was added as an independent variable in the Poisson regression model.||3.95|2.83|
71704525|NCT01487161|142927090|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.1249|TWO_SIDED|90.0|-1.2|0.2|||Longitudinal mixed effect model|||||0.2|-1.2|0.1249
71704526|NCT01487161|142927091|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2002|TWO_SIDED|90.0|-1.1|0.3|||Longitudinal mixed effect model|||||0.3|-1.1|0.2002
71704527|NCT01487161|142927092|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5541|TWO_SIDED|90.0|-0.7|0.8|||Longitudinal mixed effect model|||||0.8|-0.7|0.5541
71704528|NCT02945046|142927106|OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9093|TWO_SIDED|95.0|-2.72|2.42||Threshold for significance at 0.05 level.|ANCOVA|||||2.42|-2.72|0.9093
71704529|NCT02945046|142927106|OTHER||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.1345|TWO_SIDED|95.0|-4.49|0.61||Threshold for significance at 0.05 level.|ANCOVA|||||0.61|-4.49|0.1345
71704530|NCT02114684|142927177|SUPERIORITY|||||||0.46|||||||Fisher Exact|||comparison of culture negative results at week 8||||0.46
71704531|NCT02114684|142927177|SUPERIORITY|||||||0.43|||||||Fisher Exact|||comparison of culture negative results at month 6||||0.43
71704532|NCT02114684|142927178|SUPERIORITY|||||||0.018|||||||Gehan-Breslow-Wilcoxon test|||||||0.018
71704533|NCT02114684|142927179|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71704534|NCT02114684|142927180|SUPERIORITY|||||||0.01||||||There are significantly more adverse events in the active arm|Mantel Haenszel|||Comparison of the number of adverse events in the two arms, controlling for HIV status||||0.01
71704535|NCT02114684|142927180|SUPERIORITY|||||||0.45|||||||Mantel Haenszel|||Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status||||0.45
71704536|NCT02114684|142927181|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
71704537|NCT00990769|142927182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|5.0|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.||||>0.05
71763380|NCT01014910|143028714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|||The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).||||0.05
71704538|NCT04625972|142927185|SUPERIORITY||Relative Risk Reduction|33.31||||0.212|TWO_SIDED|95.0|-25.92|64.68|||Poisson regression||Primary Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||64.68|-25.92|0.212
71763381|NCT00612807|143028715|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|-0.56|STANDARD_ERROR_OF_MEAN|0.29||0.056||95.0||||Interaction indicates that slope of change varied by identified patient status and tx condition. Slope of change in depression was significantly negative for everyone but identified patients in the control condition.|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.056
71763382|NCT00612807|143028716|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|0.64|STANDARD_ERROR_OF_MEAN|0.65||0.32||95.0|||||Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.32
71774961|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0038||95.0|||||Wilcoxon signed rank test|||||||0.0038
71774962|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774963|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1474||95.0|||||Wilcoxon signed rank test|||||||0.1474
71774964|NCT00145600|143050139|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774965|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0281||95.0|||||Wilcoxon signed rank test|||||||0.0281
71774966|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.63|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71825544|NCT01859312|143155470|OTHER|||||||0.027|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.027
71825545|NCT01859312|143155472|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
71652883|NCT00595335|142824059|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the left eye between the two groups.||||0.49
71652884|NCT00595335|142824060|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 6 months.||||0.21
71652885|NCT00595335|142824060|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 12 months.||||0.64
71704539|NCT04625972|142927185|SUPERIORITY||Relative Risk Reduction|43.28||||0.044|TWO_SIDED|95.0|1.4|67.37|||Poisson regression||Final Analysis Estimates are based on Poisson regression with robust variance. The model includes covariate for treatment and the log of follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||67.37|1.40|0.044
71704540|NCT04625972|142927187|SUPERIORITY||Relative Risk Reduction|100.0||||0.664|ONE_SIDED|97.5|-1836.98||||Poisson regression||||||-1836.98|0.664
71704541|NCT04625972|142927188|SUPERIORITY||Relative Risk Reduction|13.9||||0.163|TWO_SIDED|95.0|-6.23|30.21|||Poisson regression|||||30.21|-6.23|0.163
71704542|NCT04625972|142927190|SUPERIORITY||Relative Risk Reduction|25.75||||0.744|TWO_SIDED|95.0|-343.53|87.57|||Poisson regression|||||87.57|-343.53|0.744
71704543|NCT02641353|142927193|OTHER||Geometric Mean Ratio|84.9|||||TWO_SIDED|90.0|77.3|93.2|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an analysis of variance (ANOVA) model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||93.2|77.3|
71704544|NCT02641353|142927193|OTHER||Geometric Mean Ratio|78.2|||||TWO_SIDED|90.0|71.2|86.0|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax.||86.0|71.2|
71704545|NCT02641353|142927194|OTHER||Geometric Mean Ratio|87.6|||||TWO_SIDED|90.0|83.0|92.5|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||92.5|83.0|
71704546|NCT02641353|142927194|OTHER||Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|109.2|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t.||121.7|109.2|
71704547|NCT02641353|142927195|OTHER||Geometric Mean Ratio|87.8|||||TWO_SIDED|90.0|83.2|92.6|||||Ratio of adjusted geometric means (Treatment B / Treatment A) expressed as a percentage.|To assess the bioavailability between the apremilast oral suspension and tablet formulation an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||92.6|83.2|
71704548|NCT02641353|142927195|OTHER||Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|109.0|121.7|||||Ratio of adjusted geometric means (Treatment C / Treatment B) expressed as a percentage.|To assess the effect of food on the PK of apremilast oral suspension formulation, an ANOVA model, with treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞.||121.7|109.0|
71704549|NCT02641353|142927196|OTHER||Median Difference|0.25||||0.1508|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon signed-rank test||Median difference (Treatment B - Treatment A) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% confidence interval (CI) of the median difference were calculated from the Hodges-Lehrmann estimate.||0.50|0.00|0.1508
71825546|NCT01859312|143155474|OTHER|||||||0.012|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.012
71704550|NCT02641353|142927196|OTHER||Median Difference|2.25|||<|0.0001|TWO_SIDED|90.0|1.27|3.25|||Wilcoxon signed-rank test||Median difference (Treatment C - Treatment B) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.25|1.27|<0.0001
71704551|NCT03259308|142927203|SUPERIORITY|||||||0.027|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.027
71704552|NCT03259308|142927203|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.014
71704553|NCT03259308|142927204|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.001
71704554|NCT03259308|142927204|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.003
71825547|NCT01859312|143155476|OTHER|||||||0.157|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.157
71652886|NCT00595335|142824061|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 6 months.||||0.36
71704555|NCT03259308|142927205|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71704556|NCT03259308|142927205|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71704557|NCT03259308|142927206|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71704558|NCT03259308|142927206|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||<0.001
71704559|NCT03259308|142927207|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
71704560|NCT03259308|142927207|SUPERIORITY|||||||0.017|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.017
71704561|NCT00694122|142927227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|277.9|STANDARD_ERROR_OF_MEAN|164.9|<|0.05|TWO_SIDED|95.0|-75.9|631.6|||t-test, 2 sided|No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.|The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).|||631.6|-75.9|<0.05
71704562|NCT00694122|142927228|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71704563|NCT00694122|142927232|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71704564|NCT00809146|142927242|NON_INFERIORITY_OR_EQUIVALENCE|Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|0.04|0.16|||one-sided z statistic|||The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.||0.16|0.04|<0.001
71704565|NCT00809146|142927243|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.7|1.34||||||||1.34|0.70|
71704566|NCT00809146|142927244|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
71704567|NCT00809146|142927245|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||||0.95|0.65|
71763383|NCT00612807|143028716|NON_INFERIORITY_OR_EQUIVALENCE|Testing whether means at each timepoint varied by identified patient status and treatment condition.|Interaction term|-12.97|STANDARD_ERROR_OF_MEAN|4.52||0.005||95.0||||We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006).|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants' baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.||||0.005
71763384|NCT01215097|143028722|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.34|||ANCOVA|||||-0.34|-0.70|<0.0001
71763385|NCT01215097|143028723|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.433|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.555|-0.311|||ANCOVA|||||-0.311|-0.555|<0.0001
71763386|NCT01215097|143028724|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.591|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001||95.0|-0.752|-0.43|||ANCOVA|||||-0.43|-0.752|<0.0001
71763387|NCT01215097|143028725|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.7|-0.35|||ANCOVA|||||-0.35|-0.70|<0.0001
71763388|NCT01215097|143028726|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.32|||ANCOVA|||||-0.32|-0.71|<0.0001
71763389|NCT01215097|143028727|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.6|STANDARD_ERROR_OF_MEAN|4.2||0.0233||95.0|-17.8|-1.3|||ANCOVA|||||-1.3|-17.8|0.0233
71763390|NCT01215097|143028728|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.1|STANDARD_ERROR_OF_MEAN|3.3|<|0.0001||95.0|-28.7|-15.6|||ANCOVA|||||-15.6|-28.7|<0.0001
71763391|NCT01215097|143028729|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|3.6||0.005||95.0|-17.3|-3.1|||ANCOVA|||||-3.1|-17.3|0.0050
71763392|NCT01215097|143028730|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.0||0.0044||95.0|-19.5|-3.6|||ANCOVA|||||-3.6|-19.5|0.0044
71763393|NCT01215097|143028732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.243|||<|0.0001||95.0|2.831|13.769|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>=7.0%||13.769|2.831|<0.0001
71763394|NCT01215097|143028734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97||||0.0129||95.0|1.404|17.592|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c \>= 6.5%||17.592|1.404|0.0129
71704568|NCT00809146|142927246|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.56||||||All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.||1.56|0.74|
71704569|NCT00809146|142927247|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.42|1.98||||||||1.98|0.42|
71704570|NCT00809146|142927248|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.3|10.7||||||||10.70|0.30|
71704571|NCT00809146|142927250|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
71704572|NCT00809146|142927251|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
71652887|NCT00595335|142824061|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 6 months.||||0.91
71652888|NCT00595335|142824061|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 12 months.||||0.29
71652889|NCT00595335|142824061|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 12 months.||||0.18
71652890|NCT00595335|142824062|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.||||0.85
71652891|NCT01131299|142824099|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||The minimum sample size to detect an 8 mg/dl change in total plasma cholesterol between the placebo and alpha cyclodextrin periods is 62 subjects. The power is 80% by using the normal approximation to a one-sample (paired) two-tail t-test at an alpha of 0.05.||||0.82
71652892|NCT01131299|142824100|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71652893|NCT01131299|142824101|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71652894|NCT01131299|142824102|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71652895|NCT02129647|142824120|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 122 (60 to 265)|||
71652896|NCT02129647|142824121|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 135 (100 to 240)|||
71652897|NCT02129647|142824122|OTHER||||||||||||||||||10 tissue matched historical controls were analyzed. The Median (Full Range) of the histoscore was 12 (0 to 100)|||
71652898|NCT01715896|142824125|SUPERIORITY_OR_OTHER||Percent difference|-3.5||||0.666|TWO_SIDED|90.0|-16.8|9.8|||Logit response Model||P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.|||9.8|-16.8|0.666
71652899|NCT01715896|142824126|SUPERIORITY_OR_OTHER||Percent difference|-8.6||||0.293|TWO_SIDED|90.0|-22.0|4.8|||Logit response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||4.8|-22.0|0.293
71652900|NCT01715896|142824127|SUPERIORITY_OR_OTHER||Percent difference|-9.8||||0.156|TWO_SIDED|90.0|-21.1|1.4|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||1.4|-21.1|0.156
71652901|NCT01715896|142824128|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108|TWO_SIDED|90.0|-23.2|0.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||0.0|-23.2|0.108
71652902|NCT01715896|142824129|SUPERIORITY_OR_OTHER||Percent difference|-10.3||||0.208|TWO_SIDED|90.0|-23.7|3.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.|||3.0|-23.7|0.2080
71704573|NCT01245062|142927270|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.64||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Investigator-Assessed PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.64|0.31|<0.0001
71652903|NCT01715896|142824136|SUPERIORITY_OR_OTHER||Adjusted Mean difference|-7.42||||0.213|TWO_SIDED|90.0|-17.24|2.4|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.|||2.40|-17.24|0.213
71652904|NCT01715896|142824138|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.129|TWO_SIDED|90.0|0.36|1.04|||Proportional odds analysis||Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.|||1.04|0.36|0.129
71652905|NCT01715896|142824139|SUPERIORITY_OR_OTHER||Percent difference|-11.6||||0.108||90.0|-23.2|0.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||0.0|-23.2|0.108
71652906|NCT01715896|142824139|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.145|TWO_SIDED|90.0|-24.8|1.4|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|The analysis reported DAS28 (CRP) low disease activity response.||1.4|-24.8|0.145
71652907|NCT01715896|142824140|SUPERIORITY_OR_OTHER|||||||0.328|||||||Log Rank|P-value was calculated using the Log rank test.||||||0.328
71652908|NCT01715896|142824141|SUPERIORITY_OR_OTHER|||||||0.003|||||||Weibull model|P-value was calculated using an Weibull model.||||||0.003
71652909|NCT01715896|142824142|SUPERIORITY_OR_OTHER||Percent difference|-1.7||||0.795|TWO_SIDED|90.0|-12.4|9.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.||9.0|-12.4|0.795
71652910|NCT01715896|142824143|SUPERIORITY_OR_OTHER||Percent difference|-11.7||||0.048|TWO_SIDED|90.0|-21.0|-2.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-2.5|-21.0|0.048
71652911|NCT01715896|142824144|SUPERIORITY_OR_OTHER||Percent difference|-11.9||||0.035|TWO_SIDED|90.0|-20.6|-3.1|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-3.1|-20.6|0.035
71763395|NCT01215097|143028735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.054|||<|0.0001||95.0|1.799|5.185|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with HbA1c at least lowering 0.5% from baseline||5.185|1.799|<0.0001
71774967|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Wilcoxon signed rank test|||||||0.0050
71774968|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.45|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71652912|NCT01715896|142824145|SUPERIORITY_OR_OTHER||Percent difference|-7.5||||0.061|TWO_SIDED|90.0|-13.6|-1.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|||-1.5|-13.6|0.061
71704574|NCT01245062|142927270|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Independent Review PFS. HR \<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|||0.60|0.29|<0.0001
71704575|NCT06025695|142927287|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in seroconversion rate|-3.73|||||TWO_SIDED|95.0|-6.93|-0.55|||||The asymptotic standardized 95% CI for the difference in seroconversion rate between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post-Dose 2.||-0.55|-6.93|
71704576|NCT06025695|142927288|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.|GMC Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.84|||||The comparison is done using the group GMC ratio (HRV PCV-free/HRV) (ANOVA model applied to the log10-transformed titers). The ANOVA model included the group as a fixed effect.|To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post-Dose 2.||0.84|0.60|
71704577|NCT06025695|142927289|NON_INFERIORITY|NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.|Difference in percentage|-6.37|||||TWO_SIDED|95.0|-10.81|-1.92|||||The asymptotic standardized 95% CI for the difference in in the percentage between HRV PCV-free Group minus HRV Group is computed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations \>=90 U/mL 1 month post-Dose 2.||-1.92|-10.81|
71704578|NCT03834883|142927293|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71704579|NCT03834883|142927294|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71704580|NCT03834883|142927295|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
71704581|NCT03834883|142927296|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71704582|NCT03834883|142927297|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71704583|NCT03834883|142927298|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71704584|NCT03834883|142927300|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
71704585|NCT03834883|142927301|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71704586|NCT03834883|142927302|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
71704587|NCT03834883|142927303|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||||||0.83
71704588|NCT03834883|142927304|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71704589|NCT00727064|142927320|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
71763396|NCT05601544|143028750|SUPERIORITY||Least-squares Mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001|TWO_SIDED|95.0|0.19|0.25||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.25|0.19|<.0001
71774969|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon signed rank test|||||||0.0005
71704590|NCT00727064|142927321|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||<0.001
71704591|NCT00727064|142927322|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.004
71704592|NCT00727064|142927323|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.018
71704593|NCT00727064|142927324|SUPERIORITY_OR_OTHER|||||||0.081|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.081
71704594|NCT00727064|142927325|SUPERIORITY_OR_OTHER|||||||0.427|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.||||||0.427
71704595|NCT00567580|142927351|SUPERIORITY||||||<|0.001||||||One-sided significance level = 0.001|Z test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
71704596|NCT00567580|142927351|SUPERIORITY|||||||0.003|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||0.003
71704597|NCT00567580|142927351|SUPERIORITY||||||<|0.001|||||||Z-test|||Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P\<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section.||||<0.001
71704598|NCT00567580|142927352|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|97.5|0.45|0.72||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.72|0.45|<0.001
71704599|NCT00567580|142927352|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|97.5|0.51|0.89||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.89|0.51|<0.001
71704600|NCT00567580|142927352|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|97.5|0.3|0.51||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.51|0.30|<0.001
71704601|NCT00567580|142927353|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.137|TWO_SIDED|97.5|0.39|1.39||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.39|0.39|0.137
71704602|NCT00567580|142927353|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.007|TWO_SIDED|97.5|0.16|0.95||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||0.95|0.16|0.007
71825548|NCT01859312|143155478|OTHER|||||||0.015|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.015
71825549|NCT01859312|143155480|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
71652913|NCT01715896|142824146|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01||||0.993|TWO_SIDED|90.0|-1.33|1.32|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in swollen joint count at Day 169.||1.32|-1.33|0.993
71652914|NCT01715896|142824146|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.23||||0.424|TWO_SIDED|90.0|-1.31|3.77|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in Tender joint count at Day 169.||3.77|-1.31|0.424
71704603|NCT00567580|142927353|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|97.5|0.12|0.68||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.68|0.12|<0.001
71825550|NCT01859312|143155482|OTHER|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.008
71825551|NCT01859312|143155484|OTHER|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.009
71652915|NCT01715896|142824147|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89||||0.272|TWO_SIDED|90.0|-2.46|12.24|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||12.24|-2.46|0.272
71652916|NCT01715896|142824148|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.46||||0.319|TWO_SIDED|90.0|-2.92|11.84|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||11.84|-2.92|0.319
71652917|NCT01715896|142824149|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.16||||0.64|TWO_SIDED|90.0|-0.42|0.74|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.74|-0.42|0.640
71652918|NCT01715896|142824150|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.18||||0.055|TWO_SIDED|90.0|0.03|0.34|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|||0.34|0.03|0.055
71652919|NCT01715896|142824151|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.06||||0.752|TWO_SIDED|90.0|0.79|1.41|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.41|0.79|0.752
71652920|NCT01715896|142824152|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05||||0.725|TWO_SIDED|90.0|0.84|1.3|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.|||1.30|0.84|0.725
71652921|NCT03923699|142824163|SUPERIORITY||Risk Ratio (RR)|0.96||||0.41|TWO_SIDED|95.0|0.85|1.08||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.08|0.85|0.41
71652922|NCT03923699|142824164|SUPERIORITY||Risk Ratio (RR)|1.0||||0.92|TWO_SIDED|95.0|0.92|1.1||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.10|0.92|0.92
71652923|NCT03923699|142824165|SUPERIORITY||Risk Ratio (RR)|0.98||||0.68|TWO_SIDED|95.0|0.89|1.09||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.09|0.89|0.68
71652924|NCT03923699|142824166|SUPERIORITY||Risk Ratio (RR)|0.98||||0.42|TWO_SIDED|95.0|0.92|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.92|0.42
71652925|NCT03923699|142824167|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.99
71652926|NCT03923699|142824168|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.95|1.05||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.05|0.95|0.95
71652927|NCT03923699|142824169|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.29|TWO_SIDED|95.0|0.0|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.00|0.29
71652928|NCT03923699|142824170|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.37|TWO_SIDED|95.0|-0.01|0.0||Not adjusted for multiple comparisons.|Regression, Linear|||||0.00|-0.01|0.37
71652929|NCT03923699|142824171|SUPERIORITY||Risk Ratio (RR)|1.03||||0.3|TWO_SIDED|95.0|0.95|1.13||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.13|0.95|0.30
71652930|NCT03923699|142824172|SUPERIORITY||Risk Ratio (RR)|1.0||||0.85|TWO_SIDED|95.0|0.98|1.02||Not adjusted for multiple comparisons.|Regression, Poisson|||||1.02|0.98|0.85
71652931|NCT03923699|142824173|SUPERIORITY||Risk Ratio (RR)|0.99||||0.51|TWO_SIDED|95.0|0.97|1.02||Not adjusted for multiple comparisons.|Regression, poisson|||||1.02|0.97|0.51
71704604|NCT00567580|142927354|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|97.5|0.14|1.01||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.01|0.14|0.010
71704605|NCT00567580|142927354|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.177|TWO_SIDED|97.5|0.14|2.3||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||2.30|0.14|0.177
71704606|NCT00567580|142927354|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|97.5|0.06|0.71||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.71|0.06|<0.001
71763397|NCT05601544|143028750|SUPERIORITY||Least-squares Mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.14|0.18||1-sided p-value was calculated using one-sided type 1 error of 0.025|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-squares mean difference was calculated as Test minus Control|It was calculated that 41 (for the Multifocal strata) and 6 (for the Sphere strata) participants in each vision group randomized in a 1:1 fashion between the two sequences would have at least a power of 90% (for the Multifocal strata) and a power of 94% (for the Sphere strata) to detect a statistical superiority with respect to visual range.||0.18|0.14|<.0001
71774970|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37||||0.0001||95.0|||||Spearman Correlation Coefficients|||||||0.0001
71774971|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||95.0|||||Wilcoxon signed rank test|||||||0.0552
71774972|NCT00145600|143050140|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774973|NCT00145600|143050141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774974|NCT00145600|143050141|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.53|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774975|NCT00145600|143050141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxan signed rank test|||||||<0.0001
71774976|NCT00145600|143050141|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.68|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774977|NCT00145600|143050141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Wilcoxon signed rank test|||||||0.0017
71652932|NCT01746264|142824174|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||P-value for change from baseline to 3 month follow-up.||||0.59
71652933|NCT01746264|142824175|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow up visit.||||<0.001
71652934|NCT01746264|142824176|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||<0.01
71652935|NCT01746264|142824178|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
71652936|NCT01746264|142824179|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3-month follow-up.||||0.21
71652937|NCT01746264|142824180|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.02
71652938|NCT01746264|142824181|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.0123
71652939|NCT01746264|142824182|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.09
71652940|NCT01746264|142824183|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.27
71652941|NCT01746264|142824184|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.18
71652942|NCT01746264|142824185|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.33
71652943|NCT01746264|142824186|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.05
71652944|NCT01746264|142824187|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.41
71652945|NCT01746264|142824188|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.32
71652946|NCT01746264|142824189|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.||||0.47
71652947|NCT01173471|142824190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|5.352||0.822|TWO_SIDED|95.0|-15.2|12.6|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||12.6|-15.2|0.822
71652948|NCT01173471|142824190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.516||0.413|TWO_SIDED|95.0|-10.1|4.3|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||4.3|-10.1|0.413
71652949|NCT01173471|142824192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.57||0.758|TWO_SIDED|95.0|-4.8|3.7|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)|||3.7|-4.8|0.758
71652950|NCT01173471|142824192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.909||0.467|TWO_SIDED|95.0|-2.5|1.2|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)|||1.2|-2.5|0.467
71652951|NCT03028740|142824193|SUPERIORITY||Percentage Difference|-3.2||||0.2067|TWO_SIDED|95.0|-8.2|1.9||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of Type 2 diabetes mellitus (T2DM) at Baseline).|Cochran-Mantel-Haenszel|||||1.9|-8.2|0.2067
71652952|NCT03028740|142824193|SUPERIORITY||Odds Ratio (OR)|0.8369|||||TWO_SIDED|95.0|0.6341|1.1044|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1044|0.6341|
71652953|NCT03028740|142824195|SUPERIORITY||Percentage Difference|-1.7||||0.2827|TWO_SIDED|95.0|-4.8|1.5||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||1.5|-4.8|0.2827
71652954|NCT03028740|142824195|SUPERIORITY||Odds Ratio (OR)|0.7844|||||TWO_SIDED|95.0|0.5032|1.2229|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.2229|0.5032|
71825552|NCT01859312|143155486|OTHER|||||||0.043|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.043
71825553|NCT01859312|143155488|OTHER|||||||0.024|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.024
71825554|NCT01859312|143155490|OTHER|||||||0.031|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.031
71652955|NCT03028740|142824196|SUPERIORITY||Percentage Difference|-2.7||||0.4054|TWO_SIDED|95.0|-8.7|3.3||P-value was based on Cochran-Mantel-Haenszel general association test comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|Cochran-Mantel-Haenszel|||||3.3|-8.7|0.4054
71652956|NCT03028740|142824196|SUPERIORITY||Odds Ratio (OR)|0.8877|||||TWO_SIDED|95.0|0.6709|1.1744|||||Odds Ratio was based on Mantel-Haenszel estimates comparing Cenicriviroc vs Placebo, controlling for factors (randomization strata: fibrosis stage \[2 vs 3\] and presence or absence of T2DM at Baseline).|||1.1744|0.6709|
71652957|NCT04060719|142824206|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.48|||||TWO_SIDED|90.0|9.74|11.28|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.28|9.74|
71652958|NCT04060719|142824207|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|30.03|||||TWO_SIDED|90.0|25.76|35.02|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 25.2.|Relative bioavailability||35.02|25.76|
71652959|NCT04060719|142824208|OTHER|No formal hypotheses were tested.|Adjusted Geometric Mean Ratio T/R [%]|10.39|||||TWO_SIDED|90.0|9.66|11.18|||Mixed Models Analysis|Mixed effects model on the logarithmic scale including effects for 'subject' (random) and 'treatment' (fixed).|Confidence intervals were calculated based on the residual error from the mixed effects model. Ratio is calculated as Test/Reference. Intra-individual geometric coefficient of variation (gCV) = 11.8.|Relative bioavailability||11.18|9.66|
71652960|NCT04578886|142824209|SUPERIORITY||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|3.7||0.22|TWO_SIDED|95.0|2.3|4.4|||t-test, 2 sided|||||4.4|2.3|0.22
71652961|NCT04578886|142824209|SUPERIORITY||Risk Ratio (RR)|1.3307||||0.015|TWO_SIDED|95.0|1.0571|1.6751||unadjusted for covariates|Regression, Linear|||"Null Hypothesis: The administration of guanfacine in critically ill patients in the intensive unit has no effect on the duration of delirium.~Continuous variables will be summarized using sample mean and sample variance whereas categorical variables will be summarized as proportions. Logistic regression models will examine whether age, gender, or comorbities associated with incidence of delirium when Guanfacine is administered."||1.6751|1.0571|0.0150
71652962|NCT03053583|142824307|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||Posthoc analysis of POGO scores were compared using the Kruskall Wallis test with Mann-WHitney test for pairwise comparisons||||<0.05
71652963|NCT03005067|142824310|OTHER||Mean Difference (Net)|0.137||||0.516|TWO_SIDED|95.0|-0.279|0.553||P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.|ANCOVA||Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.|||0.553|-0.279|0.516
71652964|NCT02296853|142824318|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|54.04|||||TWO_SIDED|90.0|41.98|69.56|||||Here, GLSM is geometric least square mean.|TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||69.56|41.98|
71652965|NCT02296853|142824318|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|63.06|||||TWO_SIDED|90.0|42.9|92.7||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||92.70|42.90|
71652966|NCT02296853|142824318|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|94.42|||||TWO_SIDED|90.0|72.48|122.99||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||122.99|72.48|
71652967|NCT02296853|142824319|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|45.1|||||TWO_SIDED|90.0|31.66|64.25||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||64.25|31.66|
71652968|NCT02296853|142824319|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|89.88|||||TWO_SIDED|90.0|64.77|124.72||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||124.72|64.77|
71825555|NCT01859312|143155492|OTHER|||||||0.005|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.005
71825556|NCT01859312|143155494|OTHER|||||||0.004|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.004
71825557|NCT01859312|143155496|OTHER|||||||0.524|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.524
71825558|NCT01859312|143155498|OTHER|||||||0.007|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.|||0.007
71825559|NCT01859312|143155500|OTHER|||||||0.084|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.084
71825560|NCT01859312|143155502|OTHER|||||||0.057|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.057
71825561|NCT01859312|143155504|OTHER|||||||0.103|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.103
71825562|NCT01859312|143155506|OTHER|||||||0.07|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.||||0.070
71825563|NCT01879371|143155509|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|107.85|||||TWO_SIDED|90.0|105.334|110.431|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|"The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect.~The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested."||110.431|105.334|
71825564|NCT01879371|143155509|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.48|||||TWO_SIDED|90.0|107.072|111.936|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.936|107.072|
71825565|NCT01879371|143155510|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|99.65|||||TWO_SIDED|90.0|93.874|105.776|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||105.776|93.874|
71825566|NCT01879371|143155510|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|70.42|||||TWO_SIDED|90.0|67.087|73.928|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||73.928|67.087|
71825567|NCT01879371|143155511|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|106.5|||||TWO_SIDED|90.0|104.05|109.004|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||109.004|104.050|
71825568|NCT01879371|143155511|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|108.59|||||TWO_SIDED|90.0|106.185|111.054|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.||111.054|106.185|
71825569|NCT03068611|143155524|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||.90
71825570|NCT03068611|143155525|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||.54
71886538|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.71|=|0.5419|TWO_SIDED|95.0|-4.4|2.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||2.3|-4.4|=0.5419
71825571|NCT03068611|143155526|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|Data were log-transformed transformed due to positive skewness||||||.36
71825572|NCT03068611|143155527|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Data were log-transformed to correct positive skewness||||||.92
71825573|NCT01467700|143155582|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.28||0.518|TWO_SIDED|98.0|-2.9|3.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.1|-2.9|0.518
71825574|NCT01467700|143155582|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.29||0.979|TWO_SIDED|98.0|-0.4|5.7||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||5.7|-0.4|0.979
71825575|NCT01467700|143155582|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.29||0.4|TWO_SIDED|99.0|-3.7|3.0||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||3.0|-3.7|0.400
71825576|NCT01467700|143155583|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.22||0.017|TWO_SIDED|98.0|-0.5|9.9||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||9.9|-0.5|0.017
71825577|NCT01467700|143155583|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.25||0.361|TWO_SIDED|98.0|-4.5|6.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||6.1|-4.5|0.361
71763398|NCT05601544|143028753|SUPERIORITY||Median Ratio|0.83||||0.0465|TWO_SIDED|98.33|0.64|1.09||1-sided p-value was calculated using one-sided type 1 error of 0.0083.|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Median Ratio was calculated as test over control|It was calculated that 16 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 92% power to detect a statistical superiority with respect to motion detection.||1.09|0.64|0.0465
71763399|NCT05601544|143028754|SUPERIORITY||Least-square Mean Difference|0.14|||<|0.0001|TWO_SIDED|98.33|0.112|0.17||1-sided p-value was calculated using one-sided type 1 error of 0.0083|Mixed Model Analysis|the Kenward and Roger method was used for the calculation of the denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|It was calculated that 29 participants in each group randomized in a 1:1 fashion between the two sequences would have at least 91% power to detect a statistical superiority with respect to motion detection.||0.170|0.112|<.0001
71763400|NCT02491632|143028755|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71825578|NCT01467700|143155583|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.23||0.002|TWO_SIDED|99.0|0.6|12.1||P-values were from an MMRM model with baseline\*week, pooled center, week, treatment, baseline, and week\*treatment as factors in the analysis.|Mixed Models Analysis|||||12.1|0.6|0.002
71886539|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.72|=|0.8585|TWO_SIDED|95.0|-3.1|3.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||3.7|-3.1|=0.8585
71652969|NCT02296853|142824319|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|82.16|||||TWO_SIDED|90.0|56.58|119.31||"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.31|56.58|
71652970|NCT02296853|142824320|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|51.2|||||TWO_SIDED|90.0|40.11|65.36||||||TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||65.36|40.11|
71652971|NCT02296853|142824320|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|62.04|||||TWO_SIDED|90.0|41.92|91.82||||||TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||91.82|41.92|
71652972|NCT02296853|142824320|EQUIVALENCE|"Sample size calculations were done in Query Advisor 6.0 by using the Two-group t-test of equal means (equal n's) module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0."|GLSM ratio percentage|93.28|||||TWO_SIDED|90.0|72.62|119.8||||||Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group||119.8|72.62|
71652973|NCT03233958|142824323|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.24|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71652974|NCT03233958|142824324|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|5.55|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71652975|NCT03233958|142824325|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.54||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
71652976|NCT03233958|142824326|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.18||||0.076|TWO_SIDED||||||ANOVA|||||||0.076
71652977|NCT03233958|142824327|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|-0.51||||0.147|TWO_SIDED||||||ANOVA|||||||0.147
71652978|NCT03233958|142824328|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.07||||0.197|TWO_SIDED||||||ANOVA|||||||0.197
71652979|NCT03233958|142824329|OTHER|Due to the single group, pre-post design, the analysis simply investigated the effect of time.|Mean Difference (Final Values)|1.25|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71652980|NCT05212883|142824347|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||Comparison of the likelihood to test before gathering for age \< 18 vs. age \>= 18.||1.3|0.8|
71652981|NCT00707447|142824362|SUPERIORITY_OR_OTHER||||||<|0.05||||||There was only one primary outcome variable, thus no adjustments for multiple comparisons were made.|t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
71652982|NCT00707447|142824363|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons||||<.05
71652983|NCT00707447|142824364|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652984|NCT00707447|142824365|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652985|NCT00707447|142824366|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652986|NCT00707447|142824367|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652987|NCT00707447|142824368|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652988|NCT00707447|142824369|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652989|NCT00707447|142824370|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652990|NCT00707447|142824371|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71652991|NCT03208673|142824381|SUPERIORITY||Ratio of Geometric mean|0.5628||||0.001|TWO_SIDED|95.0|0.4395|0.7204|||t-test, 2 sided|||||0.7204|0.4395|.001
71652992|NCT03208673|142824382|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||Nasal||||0.025
71704607|NCT00567580|142927355|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.105|TWO_SIDED|97.5|0.49|1.22||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.22|0.49|0.105
71704608|NCT00567580|142927355|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.022|TWO_SIDED|97.5|0.36|1.06||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.06|0.36|0.022
71652993|NCT03208673|142824382|SUPERIORITY|||||||0.312|||||||t-test, 1 sided|||Temporal||||0.312
71652994|NCT03208673|142824383|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Comfort||||<0.001
71652995|NCT03208673|142824383|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Dry||||<0.001
71652996|NCT03208673|142824383|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Gritty||||<0.001
71652997|NCT03208673|142824383|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Vision||||<0.001
71652998|NCT03891329|142824385|OTHER|No comparison of two groups, just single arm design|SADE-free rate in the study group|0.98||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Cor Family devices until the 3- month follow-up are counted for this primary endpoint.~The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||1|0.9|0.05
71652999|NCT03891329|142824386|OTHER|Kaplan-Meier method|||||||||||||||||The Kaplan-Meier method will be applied to estimate the 3-month SADE-free rate at 92 days after implantation (sensitivity analysis of the primary endpoint) and the 12-month SADE-free rate at 365 days after implantation.|||
71653000|NCT02740179|142824389|SUPERIORITY|||||||0.72||||||P value for Change in Coronary Flow Reserve on Cardiac PET|t-test, 2 sided|||||||0.72
71704609|NCT00567580|142927355|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|97.5|0.29|0.81||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||0.81|0.29|<0.001
71704610|NCT00567580|142927356|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.137|TWO_SIDED|97.5|0.35|1.43||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.43|0.35|0.137
71653001|NCT02740179|142824390|SUPERIORITY|||||||0.03||||||P value for Change in Stress Myocardial Blood Flow on Cardiac MRI|t-test, 2 sided|||||||0.03
71653002|NCT02740179|142824391|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
71653003|NCT02740179|142824392|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
71653004|NCT02740179|142824393|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Analyses performed on log transformation of data||||||0.03
71653005|NCT02740179|142824394|SUPERIORITY|||||||0.09||||||P value for Change in Plasma IL-6|t-test, 2 sided|Analyses performed after log transformation of data||||||0.09
71653006|NCT02740179|142824395|SUPERIORITY|||||||0.36||||||P value for Change in Plasma hsCRP|t-test, 2 sided|Analyses performed after log transformation of data||||||0.36
71653007|NCT02740179|142824396|SUPERIORITY|||||||0.88||||||P value for Change in Plasma MCP-1|t-test, 2 sided|Analyses performed after log transformation of data||||||0.88
71653008|NCT02740179|142824397|SUPERIORITY|||||||0.17||||||P value for Change in Plasma sCD163|t-test, 2 sided|Analyses performed after log transformation of data||||||0.17
71653009|NCT02740179|142824398|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|Analyses performed after log transformation of data||||||0.28
71653010|NCT02740179|142824399|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
71653011|NCT02740179|142824400|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71653012|NCT02740179|142824401|SUPERIORITY|||||||0.73|||||||Kruskal-Wallis|||||||0.73
71653013|NCT02740179|142824402|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
71653014|NCT02740179|142824403|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|||||||0.03
71653015|NCT02740179|142824404|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71653016|NCT04844021|142824454|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.22|||||TWO_SIDED|95.0|0.13|0.31||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.31|0.13|
71704611|NCT00567580|142927356|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.141|TWO_SIDED|97.5|0.3|1.54||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.54|0.30|0.141
71704612|NCT00567580|142927356|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.014|TWO_SIDED|97.5|0.21|1.03||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.03|0.21|0.014
71763401|NCT02491632|143028755|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
71653017|NCT04844021|142824454|OTHER|We used a multiple hypothesis testing framework to evaluate the effectiveness of Nudge+ vs. Nudge, considering: 1) Nudge+ is more effective than Nudge by over 10 percentage points (PP); 2) Nudge+ is as effective as Nudge, with a difference of no greater than 10 PP in either direction; and 3) Nudge+ is less effective than Nudge by over 10 PP. The 10 PP margin was selected based on discussions with health system leaders and previous studies to ensure the differences were clinically meaningful.|Marginal probability|0.49|||||TWO_SIDED|95.0|0.37|0.61||If the 95% confidence interval for the risk difference did not contain any values within a region (Nudge+ superior, equivalence, Nudge+ inferior), that region could be rejected.||||The primary analysis involved fitting generalized estimating equations (GEE) with a binomial distribution and logit link to estimate reach (primary endpoint) for Nudge and Nudge+ along with the risk difference between conditions.||0.61|0.37|
71653018|NCT01258101|142824476|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to Arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|32.0|||||TWO_SIDED|95.0|10.5|53.5||||||||53.5|10.5|
71653019|NCT01258101|142824476|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-14.0|7.6||||||||7.6|-14.0|
71653020|NCT01258101|142824476|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|-4.7|19.1||||||||19.1|-4.7|
71653021|NCT01258101|142824476|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-21.1|||||TWO_SIDED|95.0|-42.2|-0.1||||||||-0.1|-42.2|
71653022|NCT01258101|142824478|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||||0.2|-1.0|
71653023|NCT01258101|142824478|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-6.4|1.3||||||||1.3|-6.4|
71653024|NCT01258101|142824478|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.4|1.4||||||||1.4|-1.4|
71653025|NCT01258101|142824478|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||||1.7|-0.5|
71653026|NCT01258101|142824486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.2667|TWO_SIDED||||||Regression, Cox|||||||0.2667
71653027|NCT01258101|142824486|SUPERIORITY_OR_OTHER|||||||0.9999|||||||Regression, Cox|||||||0.9999
71653028|NCT01258101|142824486|SUPERIORITY_OR_OTHER|||||||0.9891|||||||Regression, Cox|||||||0.9891
71653029|NCT01298778|142824496|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||acute pain scores with movement at 24 hours||||0.05
71653030|NCT02377921|142824534|SUPERIORITY||Least Squares (LS) Mean Difference|0.74||||0.5387|TWO_SIDED|95.0|-1.61|3.09||Generalized estimating equation (GEE) model includes change from Baseline (BL) as dependent variable, visit, treatment and visit by treatment as fixed factors, and BL values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||3.09|-1.61|0.5387
71653031|NCT02377921|142824535|SUPERIORITY||LS Mean Difference|-0.4||||0.6938|TWO_SIDED|95.0|-2.38|1.58||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||1.58|-2.38|0.6938
71653032|NCT02377921|142824536|SUPERIORITY||LS Mean Difference|-1.49||||0.5023|TWO_SIDED|95.0|-5.83|2.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||2.86|-5.83|0.5023
71653033|NCT02377921|142824537|SUPERIORITY||LS Mean Difference|-0.72||||0.2739|TWO_SIDED|95.0|-2.01|0.57||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo|||0.57|-2.01|0.2739
71653034|NCT02377921|142824538|SUPERIORITY||LS Mean Difference|-2.76||||0.1235|TWO_SIDED|95.0|-6.27|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-6.27|0.1235
71653035|NCT02377921|142824539|SUPERIORITY||LS Mean Difference|-0.43||||0.3907|TWO_SIDED|95.0|-1.4|0.55||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.55|-1.40|0.3907
71653036|NCT02377921|142824540|OTHER||LS Mean Difference|-10.98||||0.1964|TWO_SIDED|95.0|-27.64|5.68||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||5.68|-27.64|0.1964
71653037|NCT02377921|142824541|SUPERIORITY||LS Mean Difference|-1.4||||0.2241|TWO_SIDED|95.0|-3.66|0.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER - placebo|||0.86|-3.66|0.2241
71704613|NCT00567580|142927357|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.235|TWO_SIDED|97.5|0.54|1.38||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.38|0.54|0.235
71704614|NCT00567580|142927357|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.481|TWO_SIDED|97.5|0.61|1.6||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT + STAD|||1.60|0.61|0.481
71704615|NCT00567580|142927357|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.213|TWO_SIDED|97.5|0.53|1.35||One-sided significance level = 0.0125|Log Rank||Reference level = PBRT Alone|||1.35|0.53|0.213
71825579|NCT01018511|143155650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Overall power was 90% power for non-inferiority vs placebo for total IPSS. Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|97.5|-1.73|0.11||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.11|-1.73|0.001
71825580|NCT01018511|143155650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.028|TWO_SIDED|97.5|-1.22|0.64||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The non-inferiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.64|-1.22|0.028
71825581|NCT01018511|143155650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.048
71825582|NCT01018511|143155650|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|TWO_SIDED|||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.||||0.483
71825583|NCT01018511|143155650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.9||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.9|-2.4|<0.001
71825584|NCT01018511|143155650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.006|TWO_SIDED|95.0|-1.9|-0.3||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of the FDC vs. placebo on the change from baseline to end of treatment in total IPSS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||-0.3|-1.9|0.006
71653038|NCT02377921|142824542|OTHER||LS Mean Difference|-0.32||||0.5608|TWO_SIDED|95.0|-1.39|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo|||0.75|-1.39|0.5608
71704616|NCT00567580|142927358|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.001|TWO_SIDED|97.5|1.81|3.37||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT Alone|Acute grade 2+ acute adverse events||3.37|1.81|<0.001
71704617|NCT00567580|142927358|SUPERIORITY||Odds Ratio (OR)|1.35||||0.007|TWO_SIDED|97.5|1.03|1.77||One-sided significance level = 0.025|Regression, Logistic|Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.|Reference level = PBRT + STAD|Acute grade 2+ acute adverse events||1.77|1.03|0.007
71704618|NCT00567580|142927358|SUPERIORITY||Odds Ratio (OR)|2.04||||0.002|TWO_SIDED|97.5|1.16|3.6||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT Alone|Acute grade 3+ acute adverse events||3.60|1.16|0.002
71704619|NCT00567580|142927358|SUPERIORITY||Odds Ratio (OR)|1.47||||0.025|TWO_SIDED|95.0|0.975|2.27||One-sided significance level = 0.025|Regression, Logistic|Univariate model was used due to the low number of events.|Reference level = PBRT + STAD|Acute grade 3+ adverse events||2.27|0.975|0.025
71763402|NCT02491632|143028755|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71704620|NCT00567580|142927359|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.268|TWO_SIDED|97.5|0.88|1.26||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 2+ adverse events||1.26|0.88|0.268
71704621|NCT00567580|142927359|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.101|TWO_SIDED|97.5|0.93|1.32||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 2+ adverse events||1.32|0.93|0.101
71704622|NCT00567580|142927359|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.119|TWO_SIDED|97.5|0.83|1.8||One-sided significance level = 0.025|Log Rank||Reference level = PBRT Alone|Late grade 3+ adverse events||1.80|0.83|0.119
71704623|NCT00567580|142927359|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.17|TWO_SIDED|97.5|0.82|1.65||One-sided significance level = 0.025|Log Rank||Reference level = PBRT + STAD|Late grade 3+ adverse events||1.65|0.82|0.170
71704624|NCT03197935|142927371|SUPERIORITY||Absolute difference in pCR rate|16.5||||0.0044|TWO_SIDED|95.0|5.91|27.1||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: tumor PD-L1 status (IC0 vs. IC1/2/3) and clinical stage at presentation (Stage II vs. III).||27.10|5.91|0.0044
71704625|NCT03197935|142927372|SUPERIORITY||Difference in pCR|19.5||||0.0206|TWO_SIDED|95.0|4.17|34.83||(one-sided)|Cochran-Mantel-Haenszel|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||34.83|4.17|0.0206
71704626|NCT03197935|142927373|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.21|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.21|0.47|
71704627|NCT03197935|142927374|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of EFS. The analyses of this secondary endpoint is descriptive in nature.|Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.26|1.18|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.18|0.26|
71704628|NCT03197935|142927375|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.44|1.3|||Stratified log-rank test|||Stratified analysis. Strata are: Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III).||1.30|0.44|
71704629|NCT03197935|142927376|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoint of DFS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.23|1.43|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.43|0.23|
71704630|NCT03197935|142927377|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.3|1.04|||Stratified log-rank test|||"Stratified analysis. Strata are:~Tumor PD-L1 status (IC0 vs IC1/2/3) and AJCC stage at diagnosis (II vs. III)."||1.04|0.30|
71704631|NCT03197935|142927378|OTHER|This study was not designed nor formally powered to demonstrate statistically significant improvements in the secondary efficacy endpoints of EFS, DFS and OS. The analyses of this secondary endpoint are descriptive in nature.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.91|||Stratified log-rank test|||Stratified analysis. Strata are: AJCC stage at diagnosis (II vs. III).||1.91|0.26|
71704632|NCT00666978|142927518|SUPERIORITY|The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.|Odds Ratio (OR)|1.39||||0.23|TWO_SIDED|95.0|0.82|2.35||All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.|t-test, 2 sided||Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .|Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.||2.35|0.82|.23
71704633|NCT00666978|142927519|OTHER||Odds Ratio (OR)|0.97||||0.0022|TWO_SIDED|95.0|0.95|0.99||This reflects Week 7.|Regression, Logistic||This reflects Week 7.|||0.99|0.95|0.0022
71704634|NCT00666978|142927520|OTHER||Odds Ratio (OR)|2.82|||<|0.05|TWO_SIDED|||||Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.|Regression, Linear||Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.|||||<0.05
71704635|NCT00676052|142927541|SUPERIORITY||Mean Difference (Net)|0.067||||0.009|TWO_SIDED|95.0|0.017|0.117||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.117|0.017|0.009
71704636|NCT00676052|142927541|SUPERIORITY||Mean Difference (Net)|0.097|||<|0.001|TWO_SIDED|95.0|0.047|0.147||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.147|0.047|<0.001
71704637|NCT00676052|142927541|SUPERIORITY||Mean Difference (Net)|0.069||||0.007|TWO_SIDED|95.0|0.019|0.118||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.118|0.019|0.007
71704638|NCT00676052|142927541|SUPERIORITY||Mean Difference (Net)|0.082||||0.001|TWO_SIDED|95.0|0.032|0.132||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.132|0.032|0.001
71763403|NCT02491632|143028755|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
71763404|NCT02491632|143028756|OTHER||||||=|0.003|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.003
71763405|NCT02491632|143028756|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
71763406|NCT02491632|143028756|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71704639|NCT00676052|142927541|SUPERIORITY||Mean Difference (Net)|0.137|||<|0.001|TWO_SIDED|95.0|0.086|0.187||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA|||||0.187|0.086|<0.001
71704640|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.065|0.146||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.146|0.065|<0.001
71704641|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.107|||<|0.001|TWO_SIDED|95.0|0.067|0.147||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.147|0.067|<0.001
71704642|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.123|||<|0.001|TWO_SIDED|95.0|0.083|0.163||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.163|0.083|<0.001
71704643|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.152|||<|0.001|TWO_SIDED|95.0|0.112|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1||0.193|0.112|<0.001
71704644|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.135|0.216||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1||0.216|0.135|<0.001
71704645|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.106|||<|0.001|TWO_SIDED|95.0|0.056|0.157||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.157|0.056|<0.001
71704646|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.192||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV, Day 28||0.192|0.092|<0.001
71704647|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.124|||<|0.001|TWO_SIDED|95.0|0.074|0.174||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28||0.174|0.074|<0.001
71704648|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.142|||<|0.001|TWO_SIDED|95.0|0.092|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.193|0.092|<0.001
71704649|NCT00676052|142927542|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.12|0.22||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28||0.220|0.120|<0.001
71704650|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.166|||<|0.001|TWO_SIDED|95.0|0.094|0.237||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.237|0.094|<0.001
71704651|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.186|||<|0.001|TWO_SIDED|95.0|0.115|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.258|0.115|<0.001
71704652|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.198|||<|0.001|TWO_SIDED|95.0|0.127|0.268||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.268|0.127|<0.001
71704653|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.244|||<|0.001|TWO_SIDED|95.0|0.172|0.315||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.315|0.172|<0.001
71704654|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.301|||<|0.001|TWO_SIDED|95.0|0.229|0.372||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1||0.372|0.229|<0.001
71704655|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.178|||<|0.001|TWO_SIDED|95.0|0.098|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.258|0.098|<0.001
71704656|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.219|||<|0.001|TWO_SIDED|95.0|0.139|0.298||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.298|0.139|<0.001
71704657|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.191|||<|0.001|TWO_SIDED|95.0|0.111|0.27||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.270|0.111|<0.001
71704658|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.232|||<|0.001|TWO_SIDED|95.0|0.152|0.312||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.312|0.152|<0.001
71763407|NCT02491632|143028756|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
71825585|NCT01018511|143155650|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.039|TWO_SIDED|95.0|-1.6|0.0||No adjustments for multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in total IPSS. With a sample size of 274 participants per arm, the overall power to meet this outcome measure was 97% power for superiority vs placebo for total IPSS.||-0.0|-1.6|0.039
71825586|NCT01018511|143155651|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||0.025|TWO_SIDED|97.5|-2.9|0.0||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.0|-2.9|0.025
71825587|NCT01018511|143155651|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.162|TWO_SIDED|97.5|-2.3|0.5||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS. A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS.||0.5|-2.3|0.162
71825588|NCT01018511|143155651|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-4.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. placebo on the change from baseline to end of treatment in TUS.||-2.5|-4.9|<0.001
71825589|NCT01018511|143155651|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.4|-1.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/9 mg vs. placebo on the change from baseline to end of treatment in TUS.||-1.9|-4.4|<0.001
71825590|NCT01018511|143155651|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in TUS.||-1.0|-3.5|<0.001
71825591|NCT01018511|143155652|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.3|-1.0|<0.001
71825592|NCT01018511|143155652|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.1|-0.6|0.223
71825593|NCT01018511|143155652|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.8|-1.5|< 0.001
71825594|NCT01018511|143155652|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-0.4|-1.1|< 0.001
71825595|NCT01018511|143155652|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.002|TWO_SIDED|95.0|-0.9|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.9|0.002
71653039|NCT02985879|142824607|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.34|=|0.998|TWO_SIDED|95.0|-2.63|2.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||2.63|-2.63|=0.998
71653040|NCT02985879|142824607|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.32|=|0.464|TWO_SIDED|95.0|-1.63|3.58|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.58|-1.63|=0.464
71653041|NCT02985879|142824609|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.88|=|0.812|TWO_SIDED|95.0|-1.52|1.93|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1.93|-1.52|=0.812
71763408|NCT02491632|143028757|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71653042|NCT02985879|142824609|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.88|=|0.104|TWO_SIDED|95.0|-0.3|3.16|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||3.16|-0.30|=0.104
71653043|NCT02985879|142824610|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16|=|0.756|TWO_SIDED|95.0|-0.36|0.26|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.26|-0.36|=0.756
71653044|NCT02985879|142824610|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16|=|0.409|TWO_SIDED|95.0|-0.44|0.18|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.18|-0.44|=0.409
71653045|NCT02985879|142824611|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|13.54|=|0.597|TWO_SIDED|95.0|-33.86|19.53|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||19.53|-33.86|=0.597
71653046|NCT02985879|142824611|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|13.56|=|0.642|TWO_SIDED|95.0|-33.04|20.42|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||20.42|-33.04|=0.642
71653047|NCT02985879|142824612|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.53|=|0.323|TWO_SIDED|95.0|-2.48|7.51|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||7.51|-2.48|=0.323
71653048|NCT02985879|142824612|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.51|=|0.974|TWO_SIDED|95.0|-4.86|5.02|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.02|-4.86|=0.974
71653049|NCT02985879|142824617|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.761|TWO_SIDED|95.0|-0.31|0.23|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.23|-0.31|=0.761
71653050|NCT02985879|142824617|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13|=|0.678|TWO_SIDED|95.0|-0.32|0.21|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.21|-0.32|=0.678
71653051|NCT02985879|142824618|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.653|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||5.57|-3.50|=0.653
71763409|NCT02491632|143028757|OTHER||||||<|0.065|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.065
71763410|NCT02491632|143028757|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71763411|NCT02491632|143028757|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||<.001
71763412|NCT02491632|143028758|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||<.001
71763413|NCT02491632|143028758|OTHER||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.30
71763414|NCT02491632|143028758|OTHER||||||=|0.19|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 8||||=.19
71763415|NCT02491632|143028758|OTHER||||||=|0.27|||||||Wilcoxon (Mann-Whitney)|||Change between Baseline and Day 29||||=.27
71763416|NCT00122980|143028772|NON_INFERIORITY_OR_EQUIVALENCE|"Based on pilot data, the efficacy of hydroxyurea to reduce secondary stroke rate was not predicted to be equivalent to transfusions. Therefore, an increased stroke rate (non-inferiority margin = 0.20) was allowed by study design. This acceptable stroke margin was predicted to be offset by the likelihood of significantly greater improvement in the management of iron overload through elimination of transfusions along with serial phlebotomy in the Hydroxyurea/Phlebotomy arm."||||||0.214||95.0|||||Log Rank|||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20, the non-inferiority margin, AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean LIC is less than for Transfusion/Chelation (see next primary endpoint analysis).||||0.214
71763417|NCT00122980|143028773|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||The a priori defined LOCF approach was deemed to be biased due to the study's early termination, and was replaced by this mixed models analysis.|Mixed Models Analysis|Including main effects of age at consent, baseline iron, and treatment group, on observed change from baseline Log10 transformed values only.||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis (see previous primary endpoint analysis) in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20 AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean log10 transformed LIC is less than for Transfusion/Chelation.||||0.144
71763418|NCT00122980|143028774|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
71763419|NCT00122980|143028775|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||>0.05
71763420|NCT00122980|143028776|SUPERIORITY_OR_OTHER|||||||0.841||95.0|||||ANOVA|||The change-from-baseline to endpoint scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||||0.841
71763421|NCT00122980|143028777|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||>0.05
71763422|NCT00122980|143028778|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.||||0.039
71763423|NCT00122980|143028779|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|Analysis controlling for baseline value and time on study.||||||0.033
71763424|NCT00122980|143028780|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Controlling for baseline value and time on study||||||<0.01
71763425|NCT01243242|143028787|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using the median test for independent samples|Median|||For the primary endpoint (CAARS change), median test was applied as the primary analysis due to outlier numbers observed ; secondary analysis of the primary endpoint utilized ANCOVA with adjustment to age, gender and site (which is usually expected to influence the endpoint) as well as baseline values. Additional parametric T-test was applied, but was found less effective due to outlier values.||||0.0093
71763426|NCT01243242|143028788|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age|ANCOVA|||Analysis of Covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) and to Visits 3 through 5 in the primary endpoint, CAARS, and secondary endpoint scales, CGI-S, TOVA and AAQoL between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0195
71763427|NCT01243242|143028789|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age.|ANCOVA|||Analysis of covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).||||0.0093
71763428|NCT00669409|143028801|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-17.8|13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.8|-17.8|
71763429|NCT00669409|143028801|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
71763430|NCT00669409|143028801|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.1|-18.5|
71763431|NCT00669409|143028801|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-29.4|1.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.8|-29.4|
71774978|NCT00145600|143050141|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71704659|NCT00676052|142927543|SUPERIORITY||Mean Difference (Net)|0.294|||<|0.001|TWO_SIDED|95.0|0.214|0.373||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28||0.373|0.214|<0.001
71704660|NCT00676052|142927544|SUPERIORITY||Mean Difference (Net)|0.099||||0.021|TWO_SIDED|95.0|0.015|0.182||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.182|0.015|0.021
71704661|NCT00676052|142927544|SUPERIORITY||Mean Difference (Net)|0.15|||<|0.001|TWO_SIDED|95.0|0.067|0.233||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.233|0.067|<0.001
71704662|NCT00676052|142927544|SUPERIORITY||Mean Difference (Net)|0.094||||0.026|TWO_SIDED|95.0|0.011|0.177||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.177|0.011|0.026
71704663|NCT00676052|142927544|SUPERIORITY||Mean Difference (Net)|0.163|||<|0.001|TWO_SIDED|95.0|0.08|0.247||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.247|0.080|<0.001
71704664|NCT00676052|142927544|SUPERIORITY||Mean Difference (Net)|0.235|||<|0.001|TWO_SIDED|95.0|0.152|0.319||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||||0.319|0.152|<0.001
71704665|NCT01967277|142927561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||H0: µL ≤ µs Versus Ha: µL \> µs||||<0.001
71704666|NCT01028560|142927574|OTHER||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis||The above is the slope for immunotherapy group . The (quadratic) slope is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with a median score values.||0.63|-0.24|0.38
71704667|NCT01028560|142927574|OTHER||Slope|0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|0.11|0.99|||Mixed Models Analysis|The above (quadratic) slope is for control group|The above is the (quadratic) slope is for control group and is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with median score values.||0.99|0.11|0.013
71704668|NCT01028560|142927574|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|4.97||0.978|TWO_SIDED|95.0|-11.76|12.03||Post estimation means were tested between the intervention arms after LME model at year 1 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.03|-11.76|0.978
71704669|NCT01028560|142927574|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|5.89||0.77|TWO_SIDED|95.0|-15.83|12.38||Post estimation means were tested between the intervention arms after LME model at year 2 and the p- value was unadjusted p value|contrast testing post mixed model]||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||12.38|-15.83|0.77
71763432|NCT00669409|143028801|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-55.2|-13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.7|-55.2|
71763433|NCT00669409|143028802|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
71704670|NCT01028560|142927574|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|7.39||0.8|TWO_SIDED|95.0|-19.54|15.84||Post estimation means were tested between the intervention arms after LME model at year 3 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.||15.84|-19.54|0.80
71763434|NCT00669409|143028802|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.8|0.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.8|
71763435|NCT00669409|143028802|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.7|19.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.9|-11.7|
71653052|NCT02985879|142824618|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|2.3|=|0.748|TWO_SIDED|95.0|-3.5|5.57|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||5.57|-3.50|=0.748
71653053|NCT02985879|142824619|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34|=|0.828|TWO_SIDED|95.0|-0.6|0.74|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||0.74|-0.60|=0.828
71763436|NCT00669409|143028802|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.6|4.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.6|-26.6|
71653054|NCT02985879|142824619|SUPERIORITY|The primary efficacy analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34|=|0.543|TWO_SIDED|95.0|-0.46|0.87|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||0.87|-0.46|=0.543
71653055|NCT02985879|142824620|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|25.44|=|0.829|TWO_SIDED|95.0|-55.66|44.63|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||44.63|-55.66|=0.829
71653056|NCT02985879|142824620|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|25.92|=|0.206|TWO_SIDED|95.0|-83.94|18.23|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||18.23|-83.94|=0.206
71653057|NCT02985879|142824621|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.88|=|0.304|TWO_SIDED|95.0|-3.65|11.65|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||11.65|-3.65|=0.304
71653058|NCT02985879|142824621|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|3.88|=|0.243|TWO_SIDED|95.0|-3.11|12.19|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||12.19|-3.11|=0.243
71653059|NCT02985879|142824622|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|53.86||0.625|TWO_SIDED|95.0|-132.76|79.94|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||79.94|-132.76|0.625
71653060|NCT02985879|142824622|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|33.2|STANDARD_ERROR_OF_MEAN|55.47|=|0.55|TWO_SIDED|95.0|-76.34|142.71|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||142.71|-76.34|=0.550
71763437|NCT00669409|143028802|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-30.5|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-30.5|
71763438|NCT00669409|143028803|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-19.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-19.4|
71763439|NCT00669409|143028803|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-34.3|-2.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.8|-34.3|
71763440|NCT00669409|143028803|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-12.6|19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.0|-12.6|
71763441|NCT00669409|143028803|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.0|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-25.0|
71763442|NCT00669409|143028803|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-25.4|16.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.1|-25.4|
71763443|NCT00669409|143028804|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-18.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-18.1|
71763444|NCT00669409|143028804|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-33.6|-2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.1|-33.6|
71763445|NCT00669409|143028804|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-17.2|14.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.4|-17.2|
71704671|NCT01028560|142927575|SUPERIORITY|||||||0.677||||||Chi-square test (proportion of new sensitizations versus unchanged or lost sensitizations in each group, intention-to treat analysis).|Chi-squared|||||||0.677
71704672|NCT01028560|142927576|SUPERIORITY||Slope|0.56||||0.546|TWO_SIDED|95.0|-2.18|3.29||Test of parallelism (group x time) hypothesis P-value.|covariance pattern (rep. measure) model|Within group difference p-values ( baseline vs 3-years) in control and intervention arm were 0.56 and 0.20 respectively.|The estimated slope reported is for year 3 from the covariance pattern model with autoregressive covariance structure.|Covariance Pattern Model with autoregressive covariance structure with REML (Restricted Estimation of Maximum Likelihood) with time and role as categorical variable was modeled.||3.29|-2.18|0.5460
71704673|NCT01028560|142927577|SUPERIORITY||Rate ratio|1.27||||0.289|TWO_SIDED|95.0|0.82|1.96||Poisson regression model for treatment arm adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst and the time period contributed by each child in years were fitted as offset.|Poisson regression|Poisson regression model with robust variance with contributed person years used as offset was modeled.||Null hypothesis = Incidence rate of CSB in each group are same. Poisson regression adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst.||1.96|0.82|0.289
71704674|NCT01243424|142927581|NON_INFERIORITY|This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.|Hazard Ratio (HR)|0.98|||<|0.0001|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test for non-inferiority were calculated.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride||||1.14|0.84|<0.0001
71704675|NCT01243424|142927581|SUPERIORITY|This was the second step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.98||||0.3813|TWO_SIDED|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.84|0.3813
71763446|NCT00669409|143028804|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-26.7|4.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.4|-26.7|
71763447|NCT00669409|143028804|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-46.5|-5.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.0|-46.5|
71763448|NCT00669409|143028805|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.6|15.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.0|-16.6|
71763449|NCT00669409|143028805|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-32.8|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.8|
71763450|NCT00669409|143028805|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.0|10.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-21.0|
71763451|NCT00669409|143028805|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.3|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-28.3|
71704676|NCT01243424|142927582|SUPERIORITY|This was the third step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.99||||0.4334|TWO_SIDED|95.47|0.86|1.14||P-values derived from Wald´s Chi-square test for non-inferiority.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.||||1.14|0.86|0.4334
71704677|NCT01243424|142927583|OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.47|1.43|1.96||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|||1.96|1.43|<0.0001
71704678|NCT01243424|142927584|OTHER||Odds Ratio (OR)|1.29||||0.0004|TWO_SIDED|95.47|1.11|1.48||p-value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.48|1.11|0.0004
71704679|NCT01243424|142927588|OTHER||Hazard Ratio (HR)|0.96||||0.5249|TWO_SIDED|95.0|0.85|1.09||p-value derived from Wald´s chi-square test.|Regression, Cox||Hazard ratio and confidence interval derived from Cox regression with factor treatment.|This was the fifth step in a pre-defined hierarchical testing approach.||1.09|0.85|0.5249
71704680|NCT01243424|142927589|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0023|TWO_SIDED|95.0|-0.15|-0.03|||ANCOVA|The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-0.03|-0.15|0.0023
71704681|NCT01243424|142927590|OTHER||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.7|-4.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||-4.8|-9.7|<0.0001
71704682|NCT01243424|142927591|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.64|TWO_SIDED|95.47|-1.3|2.1|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|LDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||2.1|-1.3|0.6400
71704683|NCT01243424|142927591|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0497|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|HDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.0|0.0|0.0497
71704684|NCT01243424|142927591|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6823|TWO_SIDED|95.0|-2.4|1.6|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.|Mean difference = Linagliptin mean - Glimepiride mean|Total cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.||1.6|-2.4|0.6823
71704685|NCT01243424|142927592|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|3.1||0.2678|TWO_SIDED|95.0|-9.6|2.7|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||2.7|-9.6|0.2678
71704686|NCT01243424|142927593|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5165|TWO_SIDED|95.0|-0.03|0.01|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||0.01|-0.03|0.5165
71704687|NCT01243424|142927594|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.4||0.5165|TWO_SIDED|95.0|0.2|1.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.|Mean difference = Linagliptin mean - Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.8|0.2|0.5165
71774979|NCT00145600|143050142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2758||95.0|||||Wilcoxon signed rank test|||||||0.2758
71704688|NCT01243424|142927595|OTHER||geometric mean (gMean) ratio (%)|0.97||||0.2921|TWO_SIDED|95.0|0.91|1.03|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.|gMean ration= Linagliptin mean/ Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.||1.03|0.91|0.2921
71704689|NCT01243424|142927597|EQUIVALENCE|This was the fifth step in a pre-defined hierarchical testing approach.|Mean Difference (Net)|4.13||||0.8402|TWO_SIDED|95.0|-36.46|44.71|||ANCOVA|The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.|Mean difference= Linagliptin mean- Glimepiride mean|||44.71|-36.46|0.8402
71704690|NCT01243424|142927598|OTHER||Odds Ratio (OR)|1.01||||0.9112|TWO_SIDED|95.0|0.86|1.18|||Regression, Logistic|Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.|Linagliptin vs. Glimepiride odds is presented.|This was the fifth step in a pre-defined hierarchical testing approach.||1.18|0.86|0.9112
71704691|NCT00397930|142927604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.3||0.009|TWO_SIDED|||||Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.|ANCOVA|ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.|The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.|"H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level."||||0.009
71704692|NCT05156125|142927632|SUPERIORITY||Risk Difference (RD)|16.1||||0.0184|TWO_SIDED|95.0|2.58|29.05|||Cochran-Mantel-Haenszel|||At 13 weeks||29.05|2.58|0.0184
71704693|NCT05156125|142927632|SUPERIORITY||Risk Difference (RD)|13.1||||0.041|TWO_SIDED|95.0|-0.03|25.58|||Cochran-Mantel-Haenszel|||At 13 weeks||25.58|-0.03|0.0410
71704694|NCT05156125|142927633|SUPERIORITY||Risk Difference (RD)|20.6||||0.007|TWO_SIDED|95.0|5.73|34.42|||Cochran-Mantel-Haenszel|||At 13 weeks||34.42|5.73|0.0070
71704695|NCT05156125|142927633|SUPERIORITY||Risk Difference (RD)|17.3||||0.0162|TWO_SIDED|95.0|2.75|30.67|||Cochran-Mantel-Haenszel|||At Week 13||30.67|2.75|0.0162
71704696|NCT05156125|142927634|SUPERIORITY||Risk Difference (RD)|16.5||||0.0448|TWO_SIDED|95.0|0.65|31.37|||Cochran-Mantel-Haenszel|||||31.37|0.65|0.0448
71774980|NCT00145600|143050142|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774981|NCT00145600|143050142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1731||95.0|||||Wilcoxon signed rank test|||||||0.1731
71774982|NCT00145600|143050142|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774983|NCT00145600|143050142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0|||||Wilcoxon signed rank test|||||||0.0846
71774984|NCT00145600|143050142|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71704697|NCT05156125|142927634|SUPERIORITY||Risk Difference (RD)|16.0||||0.0417|TWO_SIDED|95.0|0.23|30.58|||Cochran-Mantel-Haenszel|||At Week 13||30.58|0.23|0.0417
71704698|NCT05156125|142927635|SUPERIORITY||Risk Difference (RD)|11.5||||0.0499|TWO_SIDED|95.0|-0.99|23.38|||Cochran-Mantel-Haenszel|||||23.38|-0.99|0.0499
71704699|NCT05156125|142927635|SUPERIORITY||Risk Difference (RD)|21.4||||0.0011|TWO_SIDED|95.0|7.94|33.53|||Cochran-Mantel-Haenszel|||At Week 13||33.53|7.94|0.0011
71704700|NCT05156125|142927636|SUPERIORITY|||||||0.0072|||||||Cochran-Mantel-Haenszel|||At Week 13||||0.0072
71704701|NCT05156125|142927636|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||At Week 13||||<0.0001
71704702|NCT05075772|142927645|OTHER||Ratio of gMeans (%)|46.3|||||TWO_SIDED|90.0|38.3|55.9|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=28.2."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||55.9|38.3|
71704703|NCT05075772|142927646|OTHER||Ratio of gMeans (%)|26.8|||||TWO_SIDED|90.0|23.2|31.1|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)). Intra-matched-pair geometric coefficient of variation=22.5"|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||31.1|23.2|
71704704|NCT05075772|142927647|OTHER||Ratio of gMeans (%)|47.0|||||TWO_SIDED|90.0|39.0|56.6|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of SC injection (T))/(gMean of IV infusion (R)).~Intra-matched-pair geometric coefficient of variation=27.7."|The statistical model used for the analysis of this secondary endpoint was an analysis of variance (ANOVA). The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included a fixed effect for treatment assignment and a random effect for matching pair (each matched pair in the study was assigned a number for the analysis).||56.6|39.0|
71704705|NCT02993302|142927656|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71704706|NCT02993302|142927657|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71704707|NCT02993302|142927658|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71704708|NCT01755637|142927669|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean Ratio of treatments|114.37|||||TWO_SIDED|90.0|100.49|130.16|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.16|100.49|
71704709|NCT01755637|142927670|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|107.41|||||TWO_SIDED|90.0|69.03|167.13|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||167.13|69.03|
71704710|NCT01755637|142927671|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|111.28|||||TWO_SIDED|90.0|94.76|130.68|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||130.68|94.76|
71774985|NCT00145600|143050143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4263||95.0|||||Wilcoxon signed rank test|||||||0.4263
71704711|NCT01755637|142927672|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0167||||0.0011||95.0|||||Wilcoxon signed rank test|The values were not adjusted for this non-parametric analysis.|The median difference was calculated as = (Experimental-Reference)|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.0011
71704712|NCT01755637|142927673|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|112.05|||||TWO_SIDED|90.0|103.65|121.12|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||121.12|103.65|
71704713|NCT01755637|142927674|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|113.1|||||TWO_SIDED|90.0|103.4|123.71|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||123.71|103.40|
71774986|NCT00145600|143050143|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774987|NCT00145600|143050143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774988|NCT00145600|143050143|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774989|NCT00145600|143050143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||Wilcoxon signed rank test|||||||0.0468
71653061|NCT02985879|142824623|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|1739.1|STANDARD_ERROR_OF_MEAN|2502.95|=|0.488|TWO_SIDED|95.0|-3201.75|6680.02|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||6680.02|-3201.75|=0.488
71653062|NCT02985879|142824623|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|3684.9|STANDARD_ERROR_OF_MEAN|2487.32|=|0.14|TWO_SIDED|95.0|-1225.46|8595.29|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||8595.29|-1225.46|=0.140
71653063|NCT02985879|142824624|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|207.9|STANDARD_ERROR_OF_MEAN|592.68|=|0.726|TWO_SIDED|95.0|-962.98|1378.88|||Mixed-effects model, repeated measures||ABBV-8E12 2000 mg - Placebo|ABBV-8E12 2000 mg vs Placebo||1378.88|-962.98|=0.726
71653064|NCT02985879|142824624|SUPERIORITY|The analysis utilized a likelihood-based, mixed-effects model, repeated measures (MMRM) analysis of the change from baseline for each postbaseline value and compared each ABBV-8E12 dose group with the placebo group. The model, which used all observed data, included fixed, categorical effects for treatment, site, visit, baseline score-by-visit interaction and treatment-by-visit interaction, with continuous fixed covariates for the corresponding baseline score.|LS Mean Difference|133.6|STANDARD_ERROR_OF_MEAN|611.91|=|0.828|TWO_SIDED|95.0|-1075.26|1342.4|||Mixed-effects model, repeated measures||ABBV-8E12 4000 mg - Placebo|ABBV-8E12 4000 mg vs Placebo||1342.40|-1075.26|=0.828
71653065|NCT01252719|142824673|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10%, the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-5.5|4.7||||||||4.7|-5.5|
71653066|NCT01252719|142824674|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% confidence interval (CI) for the difference in response rates in the mITT population was greater than -10% the non-inferiority (NI) of oritavancin to vancomycin was concluded.|Difference in Proportions|3.4|||||TWO_SIDED|95.0|-1.6|8.4||||||||8.4|-1.6|
71653067|NCT01252719|142824675|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population was greater than -10% the NI of oritavancin to vancomycin was concluded.|Difference in Proportions|4.1|||||TWO_SIDED|95.0|-0.5|8.6||||||||8.6|-0.5|
71653068|NCT03135899|142824690|OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.048|0.165|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.165|-0.048|
71653069|NCT03135899|142824690|OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.064|||TWO_SIDED|90.0|-0.144|0.07|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.070|-0.144|
71774990|NCT00145600|143050143|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774991|NCT00145600|143050144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774992|NCT00145600|143050144|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.26||||0.0019||95.0|||||Spearman Correlation Coefficients|||||||0.0019
71774993|NCT00145600|143050144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71774994|NCT00145600|143050144|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0704||95.0|||||Spearman Correlation Coefficients|||||||0.0704
71774995|NCT00145600|143050144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon signed rank test|||||||0.0200
71774996|NCT00145600|143050144|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774997|NCT00145600|143050145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7192||95.0|||||Wilcoxon signed rank test|||||||0.7192
71774998|NCT00145600|143050145|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71774999|NCT00145600|143050145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8663||95.0|||||Wilcoxon signed rank test|||||||0.8663
71763452|NCT00669409|143028805|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-49.6|-8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.2|-49.6|
71763453|NCT00669409|143028806|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-16.8|14.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-16.8|
71653070|NCT03135899|142824690|OTHER||Mean Difference (Final Values)|-0.157|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|90.0|-0.266|-0.047|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||-0.047|-0.266|
71653071|NCT03135899|142824692|OTHER||Geometric Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.595|0.977|||Mixed Models Analysis||BI 443651 100 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||0.977|0.595|
71653072|NCT03135899|142824692|OTHER||Geometric Mean Ratio|0.926|STANDARD_ERROR_OF_MEAN|1.168|||TWO_SIDED|90.0|0.715|1.199|||Mixed Models Analysis||BI 443651 400 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.199|0.715|
71653073|NCT03135899|142824692|OTHER||Geometric Mean Ratio|0.845|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|0.651|1.095|||Mixed Models Analysis||BI 443651 1200 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included 'treatment' and 'period' as fixed effects, 'patient' as a random effect, and 'period baseline' as well as 'patient baseline' as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.||1.095|0.651|
71653074|NCT03135899|142824694|OTHER||Hazard Ratio (HR)|2.27|||||TWO_SIDED|95.0|1.31|3.95|||Regression, Cox||BI 443651 100 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.95|1.31|
71653075|NCT03135899|142824694|OTHER||Hazard Ratio (HR)|2.08|||||TWO_SIDED|95.0|1.22|3.53|||Regression, Cox||BI 443651 400 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||3.53|1.22|
71653076|NCT03135899|142824694|OTHER||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|1.5|4.47|||Regression, Cox||BI 443651 1200 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.||4.47|1.50|
71653077|NCT04146363|142824699|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.6|37.8|||Cochran-Mantel-Haenszel|||||37.8|21.6|<0.000001
71653078|NCT04146363|142824700|SUPERIORITY||Risk Difference (RD)|42.0|||<|1e-06|TWO_SIDED|95.0|33.3|50.6|||Cochran-Mantel-Haenszel|||||50.6|33.3|<0.000001
71653079|NCT04146363|142824701|SUPERIORITY||Risk Difference (RD)|1.7||||0.218644|TWO_SIDED|95.0|-0.6|4.0|||Cochran-Mantel-Haenszel|||||4.0|-0.6|0.218644
71653080|NCT04146363|142824702|SUPERIORITY||Risk Difference (RD)|9.6||||0.000498|TWO_SIDED|95.0|5.7|13.6|||Cochran-Mantel-Haenszel|||||13.6|5.7|0.000498
71653081|NCT04146363|142824703|SUPERIORITY||Risk Difference (RD)|30.8|||<|1e-06|TWO_SIDED|95.0|22.1|39.4|||Cochran-Mantel-Haenszel|||||39.4|22.1|<0.000001
71653082|NCT04146363|142824704|SUPERIORITY||Risk Difference (RD)|28.8|||<|1e-06|TWO_SIDED|95.0|21.3|36.3|||Cochran-Mantel-Haenszel|||||36.3|21.3|<0.000001
71653083|NCT04146363|142824705|SUPERIORITY||LS Mean Difference (Final Values)|-30.42|STANDARD_ERROR_OF_MEAN|3.915|<|1e-06|TWO_SIDED|95.0|-38.1|-22.7|||ANCOVA|||||-22.7|-38.1|<0.000001
71653084|NCT04146363|142824706|SUPERIORITY||Risk Difference (RD)|32.9|||<|1e-06|TWO_SIDED|95.0|24.6|41.3|||Cochran-Mantel-Haenszel|||||41.3|24.6|<0.000001
71653085|NCT04146363|142824707|SUPERIORITY||Risk Difference (RD)|35.1|||<|1e-06|TWO_SIDED|95.0|26.3|43.9|||Cochran-Mantel-Haenszel|||||43.9|26.3|<0.000001
71653086|NCT04146363|142824708|SUPERIORITY||LS Mean Difference (Final Values)|-38.31|STANDARD_ERROR_OF_MEAN|4.151|<|1e-06|TWO_SIDED|95.0|-46.4|-30.2|||ANCOVA|||||-30.2|-46.4|<0.000001
71653087|NCT04146363|142824709|SUPERIORITY||LS Mean Difference (Final Values)|-18.5|STANDARD_ERROR_OF_MEAN|2.0|<|1e-06|TWO_SIDED|95.0|-22.4|-14.5|||Mixed Models Analysis|||||-14.5|-22.4|<0.000001
71653088|NCT04146363|142824710|SUPERIORITY||Risk Difference (RD)|10.7||||0.000412|TWO_SIDED|95.0|6.2|15.2|||Cochran-Mantel-Haenszel|||||15.2|6.2|0.000412
71653089|NCT04146363|142824711|SUPERIORITY||LS Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.68|<|1e-06|TWO_SIDED|95.0|-7.1|-4.5|||ANCOVA|||||-4.5|-7.1|<0.000001
71763454|NCT00669409|143028806|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-35.0|
71763455|NCT00669409|143028806|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.8|9.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.8|-21.8|
71825596|NCT01018511|143155653|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|16.6|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|16.6|< 0.001
71825597|NCT01018511|143155653|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|23.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|16.6|29.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.8|16.6|< 0.001
71825598|NCT01018511|143155653|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.4|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|21.0|33.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.9|21.0|< 0.001
71825599|NCT01018511|143155653|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|27.6|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|21.1|34.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||34.1|21.1|< 0.001
71825600|NCT01018511|143155653|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|3.32||0.189|TWO_SIDED|95.0|-2.2|10.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||10.9|-2.2|0.189
71825601|NCT01018511|143155654|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.5|STANDARD_ERROR_OF_MEAN|7.51||0.053|TWO_SIDED|95.0|-0.2|29.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.3|-0.2|0.053
71886540|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.99|=|0.5521|TWO_SIDED|95.0|-5.1|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||2.7|-5.1|=0.5521
71653090|NCT04146363|142824712|SUPERIORITY||Risk Difference (RD)|38.8|||<|1e-06|TWO_SIDED|95.0|28.3|49.3|||Cochran-Mantel-Haenszel|||||49.3|28.3|<0.000001
71653091|NCT04146363|142824713|SUPERIORITY||Risk Difference (RD)|41.8|||<|1e-06|TWO_SIDED|95.0|31.2|52.3|||Cochran-Mantel-Haenszel|||||52.3|31.2|<0.000001
71653092|NCT04146363|142824714|SUPERIORITY||LS Mean Difference (Final Values)|-32.35|STANDARD_ERROR_OF_MEAN|5.23|<|1e-06|TWO_SIDED|95.0|-42.6|-22.1|||ANCOVA|||||-22.1|-42.6|<0.000001
71653093|NCT04146363|142824715|SUPERIORITY||LS Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.098|<|1e-06|TWO_SIDED|95.0|-0.9|-0.6|||ANCOVA|||||-0.6|-0.9|<0.000001
71653094|NCT04146363|142824716|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|26.2|43.0|||Cochran-Mantel-Haenszel|||||43.0|26.2|<0.000001
71653095|NCT04146363|142824717|SUPERIORITY||Risk Difference (RD)|1.5||||0.275529|TWO_SIDED|95.0|-0.8|3.9|||Cochran-Mantel-Haenszel|||||3.9|-0.8|0.275529
71653096|NCT04146363|142824718|SUPERIORITY||Risk Difference (RD)|5.3||||0.016656|TWO_SIDED|95.0|1.9|8.6|||Cochran-Mantel-Haenszel|||||8.6|1.9|0.016656
71653097|NCT04146363|142824719|SUPERIORITY||Risk Difference (RD)|19.3||||3e-06|TWO_SIDED|95.0|13.7|25.0|||Cochran-Mantel-Haenszel|||||25.0|13.7|0.000003
71653098|NCT04146363|142824720|SUPERIORITY||Risk Difference (RD)|1.8||||0.244105|TWO_SIDED|95.0|-0.8|4.3|||Cochran-Mantel-Haenszel|||||4.3|-0.8|0.244105
71653099|NCT04146363|142824721|SUPERIORITY||Risk Difference (RD)|5.8||||0.01445|TWO_SIDED|95.0|2.2|9.4|||Cochran-Mantel-Haenszel|||||9.4|2.2|0.014450
71653100|NCT04146363|142824722|SUPERIORITY||Risk Difference (RD)|20.9||||2e-06|TWO_SIDED|95.0|14.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|14.9|0.000002
71653101|NCT04146363|142824723|SUPERIORITY||LS Mean Difference (Final Values)|-30.29|STANDARD_ERROR_OF_MEAN|3.203|<|1e-06|TWO_SIDED|95.0|-36.59|-24.0|||ANCOVA|||||-24.00|-36.59|<0.000001
71653102|NCT04146363|142824725|SUPERIORITY||Risk Difference (RD)|17.9||||0.072375|TWO_SIDED|95.0|-2.3|38.1|||Cochran-Mantel-Haenszel|||||38.1|-2.3|0.072375
71653103|NCT04146363|142824725|SUPERIORITY||Risk Difference (RD)|17.5||||0.106653|TWO_SIDED|95.0|-4.5|39.5|||Cochran-Mantel-Haenszel|||||39.5|-4.5|0.106653
71653104|NCT04146363|142824726|SUPERIORITY||Risk Difference (RD)|28.0||||0.029857|TWO_SIDED|95.0|2.8|53.2|||Cochran-Mantel-Haenszel|||||53.2|2.8|0.029857
71653105|NCT04146363|142824726|SUPERIORITY||Risk Difference (RD)|29.0||||0.019744|TWO_SIDED|95.0|4.6|53.3|||Cochran-Mantel-Haenszel|||||53.3|4.6|0.019744
71653106|NCT04146363|142824727|SUPERIORITY||Risk Difference (RD)|15.8||||0.268265|TWO_SIDED|95.0|-12.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|-12.2|0.268265
71653107|NCT04146363|142824727|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
71653108|NCT04146363|142824728|SUPERIORITY||Risk Difference (RD)|18.6||||0.185361|TWO_SIDED|95.0|-9.3|46.6|||Cochran-Mantel-Haenszel|||||46.6|-9.3|0.185361
71653109|NCT04146363|142824728|SUPERIORITY||Risk Difference (RD)|16.6||||0.192776|TWO_SIDED|95.0|-9.4|42.7|||Cochran-Mantel-Haenszel|||||42.7|-9.4|0.192776
71653110|NCT04146363|142824729|SUPERIORITY||LS Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|4.756||0.714208|TWO_SIDED|95.0|-11.15|7.66|||ANCOVA|||||7.66|-11.15|0.714208
71653111|NCT04146363|142824729|SUPERIORITY||LS Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|4.4748||0.237855|TWO_SIDED|95.0|-15.01|3.76|||ANCOVA|||||3.76|-15.01|0.237855
71653112|NCT04146363|142824730|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|1e-06|TWO_SIDED|95.0|0.1|0.2|||ANCOVA|||UK||0.2|0.1|<0.000001
71653113|NCT04146363|142824730|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.01|<|1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||US||0.1|0.1|<0.000001
71763456|NCT00669409|143028806|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-28.0|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-28.0|
71825602|NCT01018511|143155654|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|14.7|STANDARD_ERROR_OF_MEAN|7.59||0.053|TWO_SIDED|95.0|-0.2|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||29.6|-0.2|0.053
71763457|NCT00669409|143028806|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-50.6|-9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.1|-50.6|
71763458|NCT00669409|143028807|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-11.9|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-11.9|
71763459|NCT00669409|143028807|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-35.1|-3.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-35.1|
71763460|NCT00669409|143028807|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-21.3|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.3|
71763461|NCT00669409|143028807|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-27.8|3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.4|-27.8|
71763462|NCT00669409|143028807|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-25.0|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-45.8|-4.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.3|-45.8|
71763463|NCT00669409|143028808|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-9.1|22.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.5|-9.1|
71763464|NCT00669409|143028808|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-31.7|-0.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-31.7|
71653114|NCT04146363|142824731|SUPERIORITY||LS Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|1.66|<|1e-06|TWO_SIDED|95.0|5.0|11.5|||ANCOVA|||||11.5|5.0|<0.000001
71763465|NCT00669409|143028808|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-18.5|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-18.5|
71763466|NCT00669409|143028808|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-25.9|5.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.3|-25.9|
71763467|NCT00669409|143028808|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-44.2|-2.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.7|-44.2|
71653115|NCT04146363|142824732|SUPERIORITY||LS Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|0.8|<|1e-06|TWO_SIDED|95.0|-8.9|-5.7|||Mixed Models Analysis|||||-5.7|-8.9|<0.000001
71653116|NCT04146363|142824733|SUPERIORITY||LS Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.917||0.716224|TWO_SIDED|95.0|-6.93|4.8|||ANCOVA|||||4.80|-6.93|0.716224
71653117|NCT04146363|142824734|SUPERIORITY||LS Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|2.599||0.089275|TWO_SIDED|95.0|-9.73|0.72|||ANCOVA|||||0.72|-9.73|0.089275
71653118|NCT04146363|142824735|SUPERIORITY||LS Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.796||4e-05|TWO_SIDED|95.0|-4.88|-1.75|||ANCOVA|||||-1.75|-4.88|0.000040
71763468|NCT00669409|143028809|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.6|27.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.0|-4.6|
71763469|NCT00669409|143028809|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.5|-30.0|
71763470|NCT00669409|143028809|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.3|17.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.3|-14.3|
71763471|NCT00669409|143028809|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.9|9.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.3|-21.9|
71763472|NCT00669409|143028809|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-40.5|1.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.0|-40.5|
71763473|NCT00669409|143028810|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.0|26.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.6|-5.0|
71653119|NCT04146363|142824736|SUPERIORITY||LS Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.697||0.000127|TWO_SIDED|95.0|-4.07|-1.33|||ANCOVA|||||-1.33|-4.07|0.000127
71653120|NCT04146363|142824737|SUPERIORITY||LS Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.121||0.455291|TWO_SIDED|95.0|-0.33|0.15|||ANCOVA|||||0.15|-0.33|0.455291
71653121|NCT04146363|142824738|SUPERIORITY||LS Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.52||6.9e-05|TWO_SIDED|95.0|-10.1|-3.9|||Mixed Models Analysis|||||-3.9|-10.1|0.000069
71653122|NCT02914236|142824739|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the mean improvement in NOSE score exceeded 15 points||||||<0.0001
71653123|NCT02914236|142824740|SUPERIORITY||||||<|0.0001|||||||binomial test|Success threshold required at least 55% of subjects to be responders||||||<0.0001
71653124|NCT01117337|142824783|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
71653125|NCT01117337|142824784|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||||||0.56
71653126|NCT03575871|142824785|SUPERIORITY||Difference in Percentage|19.3||||0.0008|TWO_SIDED|95.0|9.6|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|9.6|0.0008
71653127|NCT03575871|142824785|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|18.6|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|18.6|<0.0001
71653128|NCT03575871|142824786|SUPERIORITY||Difference in Percentage|33.9|||<|0.0001|TWO_SIDED|95.0|23.3|44.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.4|23.3|<0.0001
71763474|NCT00669409|143028810|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-30.0|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.0|
71763475|NCT00669409|143028810|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.6|17.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.0|-14.6|
71763476|NCT00669409|143028810|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-21.0|10.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.2|-21.0|
71763477|NCT00669409|143028810|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-35.3|6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.2|-35.3|
71763478|NCT00669409|143028811|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-5.5|26.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.1|-5.5|
71763479|NCT00669409|143028811|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-27.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-27.0|
71763480|NCT00669409|143028811|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-13.3|18.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.3|-13.3|
71763481|NCT00669409|143028811|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-19.2|
71763482|NCT00669409|143028811|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-34.4|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-34.4|
71763483|NCT00669409|143028812|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.0|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.8|26.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||26.8|-4.8|
71763484|NCT00669409|143028812|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-8.1|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-23.9|7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.6|-23.9|
71763485|NCT00669409|143028812|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|1.8|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-14.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-14.0|
71763486|NCT00669409|143028812|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.88|||TWO_SIDED|95.0|-19.2|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
71763487|NCT00669409|143028812|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-12.8|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-33.5|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-33.5|
71763488|NCT00669409|143028813|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|11.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-4.4|27.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.2|-4.4|
71763489|NCT00669409|143028813|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.98|||TWO_SIDED|95.0|-21.2|10.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.3|-21.2|
71763490|NCT00669409|143028813|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|95.0|-11.2|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-11.2|
71653129|NCT03575871|142824786|SUPERIORITY||Difference in Percentage|50.5|||<|0.0001|TWO_SIDED|95.0|40.0|60.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.9|40.0|<0.0001
71738893|NCT04038567|142990621|SUPERIORITY||Mean Difference (Final Values)|4.82|||||TWO_SIDED|95.0|-0.76|10.4||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||10.40|-0.76|
71653130|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|19.2||||0.0002|TWO_SIDED|95.0|11.0|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|11.0|0.0002
71653131|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|31.2|||<|0.0001|TWO_SIDED|95.0|22.3|40.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.2|22.3|<0.0001
71653132|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|27.5|||<|0.0001|TWO_SIDED|95.0|18.9|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|18.9|<0.0001
71653133|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|46.4|||<|0.0001|TWO_SIDED|95.0|37.2|55.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.7|37.2|<0.0001
71653134|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|27.4|||<|0.0001|TWO_SIDED|95.0|16.8|38.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.0|16.8|<0.0001
71653135|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|39.8|||<|0.0001|TWO_SIDED|95.0|28.9|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|28.9|<0.0001
71653136|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|18.9|39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.6|18.9|<0.0001
71653137|NCT03575871|142824787|SUPERIORITY||Difference in Percentage|38.6|||<|0.0001|TWO_SIDED|95.0|28.1|49.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.1|28.1|<0.0001
71653138|NCT03575871|142824788|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
71653139|NCT03575871|142824788|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.6|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.6|-2.8|<0.0001
71653140|NCT03575871|142824790|SUPERIORITY||Difference in Percentage|8.8||||0.015|TWO_SIDED|95.0|2.8|14.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.9|2.8|0.0150
71653141|NCT03575871|142824790|SUPERIORITY||Difference in Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|15.0|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|15.0|<0.0001
71653142|NCT03575871|142824790|SUPERIORITY||Difference in Percentage|20.0||||0.0004|TWO_SIDED|95.0|10.9|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.0|10.9|0.0004
71653143|NCT03575871|142824790|SUPERIORITY||Difference in Percentage|44.3|||<|0.0001|TWO_SIDED|95.0|34.8|53.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.8|34.8|<0.0001
71653144|NCT03575871|142824790|SUPERIORITY||Difference in Percentage|30.4|||<|0.0001|TWO_SIDED|95.0|19.7|41.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||41.2|19.7|<0.0001
71653145|NCT03575871|142824790|SUPERIORITY||Difference in Percentage|47.4|||<|0.0001|TWO_SIDED|95.0|36.8|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|36.8|<0.0001
71775000|NCT00145600|143050145|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71763491|NCT00669409|143028813|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-20.3|10.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-20.3|
71763492|NCT00669409|143028813|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.1|STANDARD_ERROR_OF_MEAN|10.48|||TWO_SIDED|95.0|-24.9|16.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.6|-24.9|
71763493|NCT00669409|143028814|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.7|12.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.3|-20.7|
71763494|NCT00669409|143028814|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.6|-3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.0|-35.6|
71653146|NCT03575871|142824791|SUPERIORITY||Difference in Percentage|5.1||||0.0459|TWO_SIDED|95.0|0.2|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.2|0.0459
71653147|NCT03575871|142824791|SUPERIORITY||Difference in Percentage|14.2||||0.0005|TWO_SIDED|95.0|7.8|20.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.5|7.8|0.0005
71653148|NCT03575871|142824791|SUPERIORITY||Difference in Percentage|12.9||||0.0019|TWO_SIDED|95.0|6.3|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.3|0.0019
71704714|NCT01755637|142927675|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|114.33|||||TWO_SIDED|90.0|102.99|126.93|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||126.93|102.99|
71704715|NCT04053452|142927682|OTHER||Area under the curve|0.7262|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
71704716|NCT04053452|142927683|OTHER||Area under the curve|0.6667|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
71704717|NCT04053452|142927684|OTHER||Area under the curve|0.7083|||||TWO_SIDED||||||||Area under the receiver operating characteristic (ROC) curve.|||||
71704718|NCT04053452|142927685|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.0623|||||TWO_SIDED|95.0|-0.5005|0.4791||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4791|-0.5005|
71704719|NCT04053452|142927685|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.1628|||||TWO_SIDED|95.0|-0.6503|0.4222||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4222|-0.6503|
71704720|NCT04053452|142927685|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.185|||||TWO_SIDED|95.0|-0.549|0.1829||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1829|-0.5490|
71704721|NCT04053452|142927685|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.0512|||||TWO_SIDED|95.0|-0.3411|0.5017||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5017|-0.3411|
71704722|NCT04053452|142927685|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.0476|||||TWO_SIDED|95.0|-0.4335|0.5592||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5592|-0.4335|
71704723|NCT04053452|142927685|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.1229|||||TWO_SIDED|95.0|-0.5092|0.304||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3040|-0.5092|
71704724|NCT04053452|142927685|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.0603|||||TWO_SIDED|95.0|-0.3057|0.4137||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4137|-0.3057|
71704725|NCT04053452|142927685|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.1059|||||TWO_SIDED|95.0|-0.4028|0.57||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.5700|-0.4028|
71704726|NCT04053452|142927685|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.1786|||||TWO_SIDED|95.0|-0.6503|0.2838||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.2838|-0.6503|
71704727|NCT04053452|142927685|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.2396|||||TWO_SIDED|95.0|-0.5714|0.195||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.1950|-0.5714|
71704728|NCT04053452|142927685|OTHER|C6|Kendall's tau correlation coefficient|-0.0671|||||TWO_SIDED|95.0|-0.4667|0.3336||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3336|-0.4667|
71704729|NCT04053452|142927685|OTHER|C7|Kendall's tau correlation coefficient|-0.2134|||||TWO_SIDED|95.0|-0.7018|0.3193||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.3193|-0.7018|
71704730|NCT04053452|142927685|OTHER|Vagus|Kendall's tau correlation coefficient|0.0246|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and length of hospital stay.||0.4596|-0.3506|
71763495|NCT00669409|143028814|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.5|12.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.1|-20.5|
71763496|NCT00669409|143028814|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-15.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.9|0.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.3|-31.9|
71704731|NCT04053452|142927686|OTHER|Median at wrist|Odds Ratio (OR)|0.7686494||||0.36|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.360
71704732|NCT04053452|142927686|OTHER|Median at forearm|Odds Ratio (OR)|0.9315228||||0.521|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.521
71704733|NCT04053452|142927686|OTHER|Median at cubital fossa|Odds Ratio (OR)|0.7949528||||0.245|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.245
71704734|NCT04053452|142927686|OTHER|Median at humerus|Odds Ratio (OR)|0.8603349||||0.541|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.541
71704735|NCT04053452|142927686|OTHER|Median at axilla|Odds Ratio (OR)|0.8767973||||0.415|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.415
71704736|NCT04053452|142927686|OTHER|Ulnar at wrist|Odds Ratio, log|0.7613965||||0.504|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.504
71704737|NCT04053452|142927686|OTHER|Ulnar at forearm|Odds Ratio (OR)|0.8061505||||0.393|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.393
71704738|NCT04053452|142927686|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|0.8336885||||0.222|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.222
71704739|NCT04053452|142927686|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.1214848||||0.615|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.615
71704740|NCT04053452|142927686|OTHER|Ulnar at axilla|Odds Ratio (OR)|0.9898411||||0.926|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.926
71704741|NCT04053452|142927686|OTHER|C6|Odds Ratio (OR)|0.9402829||||0.519|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.519
71704742|NCT04053452|142927686|OTHER|C7|Odds Ratio (OR)|0.9347906||||0.379|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.379
71704743|NCT04053452|142927686|OTHER|Vagus|Odds Ratio (OR)|0.8968658||||0.511|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of walking (i.e., nerve ultrasound measurements do not predict whether a subject is ambulatory at discharge).||||0.511
71704744|NCT04053452|142927687|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.057735|||||TWO_SIDED|95.0|-0.4273|0.3293||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3293|-0.4273|
71704745|NCT04053452|142927687|OTHER|Median at forearm|Kendall's tau correlation coefficient|-0.0359442|||||TWO_SIDED|95.0|-0.548|0.5248||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5248|-0.5480|
71704746|NCT04053452|142927687|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.1429483|||||TWO_SIDED|95.0|-0.1938|0.4763||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.4763|-0.1938|
71704747|NCT04053452|142927687|OTHER|Median at humerus|Kendall's tau correlation coefficient|-0.3955939|||||TWO_SIDED|95.0|-0.6811|-0.0874||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.0874|-0.6811|
71704748|NCT04053452|142927687|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.3681051|||||TWO_SIDED|95.0|-0.7032|0.1185||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.1185|-0.7032|
71704749|NCT04053452|142927687|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.4938292|||||TWO_SIDED|95.0|-0.7112|-0.1978||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.1978|-0.7112|
71704750|NCT04053452|142927687|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.1304373|||||TWO_SIDED|95.0|-0.2201|0.5014||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.5014|-0.2201|
71704751|NCT04053452|142927687|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|0.3273268|||||TWO_SIDED|95.0|-0.0679|0.6612||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.6612|-0.0679|
71704752|NCT04053452|142927687|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|-0.0552157|||||TWO_SIDED|95.0|-0.4213|0.361||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.3610|-0.4213|
71704753|NCT04053452|142927687|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|-0.1666667|||||TWO_SIDED|95.0|-0.5389|0.2057||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2057|-0.5389|
71704754|NCT04053452|142927687|OTHER|C6|Kendall's tau correlation coefficient|-0.3194892|||||TWO_SIDED|95.0|-0.6539|0.2288||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.2288|-0.6539|
71704755|NCT04053452|142927687|OTHER|C7|Kendall's tau correlation coefficient|-0.4959498|||||TWO_SIDED|95.0|-0.686|-0.2065||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||-0.2065|-0.6860|
71704756|NCT04053452|142927687|OTHER|Vagus|Kendall's tau correlation coefficient|-0.3228883|||||TWO_SIDED|95.0|-0.6487|0.0||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and respiratory dysfunction.||0.0000|-0.6487|
71704757|NCT04053452|142927688|OTHER|Median at wrist|Kendall's tau correlation coefficient|-0.1415346|||||TWO_SIDED|95.0|-0.735|0.4247||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4247|-0.7350|
71704758|NCT04053452|142927688|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1987845|||||TWO_SIDED|95.0|-0.4377|0.8004||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.8004|-0.4377|
71704759|NCT04053452|142927688|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|-0.0789747|||||TWO_SIDED|95.0|-0.5256|0.3778||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.3778|-0.5256|
71704760|NCT04053452|142927688|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.1621509|||||TWO_SIDED|95.0|-0.3591|0.5606||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5606|-0.3591|
71704761|NCT04053452|142927688|OTHER|Median at axilla|Kendall's tau correlation coefficient|0.1499412|||||TWO_SIDED|95.0|-0.3901|0.6374||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6374|-0.3901|
71704762|NCT04053452|142927688|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0140441|||||TWO_SIDED|95.0|-0.5773|0.5407||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5407|-0.5773|
71704763|NCT04053452|142927688|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|0.01383297|||||TWO_SIDED|95.0|-0.5288|0.5485||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5485|-0.5288|
71704764|NCT04053452|142927688|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.2935683|||||TWO_SIDED|95.0|-0.6968|0.2414||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.2414|-0.6968|
71704765|NCT04053452|142927688|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.1067521|||||TWO_SIDED|95.0|-0.5204|0.6392||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.6392|-0.5204|
71704766|NCT04053452|142927688|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.0549235|||||TWO_SIDED|95.0|-0.4633|0.5594||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.5594|-0.4633|
71704767|NCT04053452|142927688|OTHER|C6|Kendall's tau correlation coefficient|-0.2597622|||||TWO_SIDED|95.0|-0.6816|0.1857||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.1857|-0.6816|
71704768|NCT04053452|142927688|OTHER|C7|Kendall's tau correlation coefficient|-0.0129034|||||TWO_SIDED|95.0|-0.4476|0.4025||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4025|-0.4476|
71704769|NCT04053452|142927688|OTHER|Vagus|Kendall's tau correlation coefficient|0.02457737|||||TWO_SIDED|95.0|-0.3506|0.4596||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by hand dynamometer.||0.4596|-0.3506|
71704770|NCT04053452|142927689|OTHER|Median at wrist|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
71704771|NCT04053452|142927689|OTHER|Median at forearm|Kendall's tau correlation coefficient|0.1704986|||||TWO_SIDED|95.0|-0.395|0.6584||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6584|-0.3950|
71704772|NCT04053452|142927689|OTHER|Median at cubital fossa|Kendall's tau correlation coefficient|0.09040847|||||TWO_SIDED|95.0|-0.3821|0.5979||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5979|-0.3821|
71704773|NCT04053452|142927689|OTHER|Median at humerus|Kendall's tau correlation coefficient|0.02501955|||||TWO_SIDED|95.0|-0.4158|0.479||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4790|-0.4158|
71704774|NCT04053452|142927689|OTHER|Median at axilla|Kendall's tau correlation coefficient|-0.0349215|||||TWO_SIDED|95.0|-0.5033|0.443||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4430|-0.5033|
71704775|NCT04053452|142927689|OTHER|Ulnar at wrist|Kendall's tau correlation coefficient|-0.0961|||||TWO_SIDED|95.0|-0.5458|0.4037||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4037|-0.5458|
71704776|NCT04053452|142927689|OTHER|Ulnar at forearm|Kendall's tau correlation coefficient|-0.2239171|||||TWO_SIDED|95.0|-0.6514|0.2935||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2935|-0.6514|
71704777|NCT04053452|142927689|OTHER|Ulnar at cubital fossa|Kendall's tau correlation coefficient|-0.0805076|||||TWO_SIDED|95.0|-0.5371|0.2974||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.2974|-0.5371|
71704778|NCT04053452|142927689|OTHER|Ulnar at humerus|Kendall's tau correlation coefficient|0.2910126|||||TWO_SIDED|95.0|-0.2791|0.7651||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.7651|-0.2791|
71704779|NCT04053452|142927689|OTHER|Ulnar at axilla|Kendall's tau correlation coefficient|0.02342428|||||TWO_SIDED|95.0|-0.4531|0.5267||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.5267|-0.4531|
71704780|NCT04053452|142927689|OTHER|C6|Kendall's tau correlation coefficient|0.06536087|||||TWO_SIDED|95.0|-0.2786|0.4454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4454|-0.2786|
71704781|NCT04053452|142927689|OTHER|C7|Kendall's tau correlation coefficient|0.2207792|||||TWO_SIDED|95.0|-0.2459|0.6708||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.6708|-0.2459|
71704782|NCT04053452|142927689|OTHER|Vagus|Kendall's tau correlation coefficient|0.14415|||||TWO_SIDED|95.0|-0.2333|0.4899||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and strength by MRC sum score.||0.4899|-0.2333|
71704783|NCT04053452|142927690|OTHER|Median at wrist|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
71704784|NCT04053452|142927690|OTHER|Median at forearm|Odds Ratio (OR)|0.9310743||||0.548|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.548
71775001|NCT00145600|143050145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7626||95.0|||||Wilcoxon signed rank test|||||||0.7626
71653149|NCT03575871|142824791|SUPERIORITY||Difference in Percentage|31.8|||<|0.0001|TWO_SIDED|95.0|23.6|39.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.9|23.6|<0.0001
71704785|NCT04053452|142927690|OTHER|Median at cubital fossa|Odds Ratio (OR)|1.23944918||||0.25|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.250
71704786|NCT04053452|142927690|OTHER|Median at humerus|Odds Ratio (OR)|0.9613236||||0.874|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.874
71775002|NCT00145600|143050145|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.58|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71653150|NCT03575871|142824791|SUPERIORITY||Difference in Percentage|11.9||||0.0246|TWO_SIDED|95.0|2.4|21.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.4|2.4|0.0246
71653151|NCT03575871|142824791|SUPERIORITY||Difference in Percentage|26.9|||<|0.0001|TWO_SIDED|95.0|17.0|36.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.9|17.0|<0.0001
71653152|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value was not estimable since there were no events.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
71653153|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|1.9||||0.2262|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2262
71653154|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|1.9||||0.2223|TWO_SIDED|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.1|-2.2|0.2223
71653155|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|4.5||||0.0597|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0597
71653156|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
71653157|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|4.5||||0.0586|TWO_SIDED|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-0.2|0.0586
71653158|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
71653159|NCT03575871|142824792|SUPERIORITY||Difference in Percentage|6.3||||0.0244|TWO_SIDED|95.0|1.2|11.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.4|1.2|0.0244
71653160|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|25.0|||<|0.0001|TWO_SIDED|95.0|14.8|35.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.2|14.8|<0.0001
71653161|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|44.2|||<|0.0001|TWO_SIDED|95.0|33.9|54.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||54.6|33.9|<0.0001
71653162|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|17.5|42.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.8|17.5|<0.0001
71653163|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|49.8|||<|0.0001|TWO_SIDED|95.0|37.8|61.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.7|37.8|<0.0001
71704787|NCT04053452|142927690|OTHER|Median at axilla|Odds Ratio (OR)|0.9442314||||0.698|TWO_SIDED|95.0|||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.698
71825603|NCT01018511|143155654|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.5|STANDARD_ERROR_OF_MEAN|7.37||0.012|TWO_SIDED|95.0|4.1|33.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.0|4.1|0.012
71825604|NCT01018511|143155654|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|18.7|STANDARD_ERROR_OF_MEAN|7.45||0.012|TWO_SIDED|95.0|4.1|33.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||33.4|4.1|0.012
71825605|NCT01018511|143155654|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|7.49||0.591|TWO_SIDED|95.0|-10.7|18.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||18.7|-10.7|0.591
71825606|NCT01018511|143155655|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.616|TWO_SIDED|95.0|-0.6|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.4|-0.6|0.616
71704788|NCT04053452|142927690|OTHER|Ulnar at wrist|Odds Ratio (OR)|1.193941||||0.665|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.665
71704789|NCT04053452|142927690|OTHER|Ulnar at forearm|Odds Ratio (OR)|1.0524489||||0.82|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.820
71704790|NCT04053452|142927690|OTHER|Ulnar at cubital fossa|Odds Ratio (OR)|1.21669122||||0.193|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.193
71704791|NCT04053452|142927690|OTHER|Ulnar at humerus|Odds Ratio (OR)|1.2994068||||0.314|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.314
71704792|NCT04053452|142927690|OTHER|Ulnar at axilla|Odds Ratio (OR)|1.1015629||||0.405|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.405
71704793|NCT04053452|142927690|OTHER|C6|Odds Ratio (OR)|0.9140133||||0.389|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.389
71704794|NCT04053452|142927690|OTHER|C7|Odds Ratio (OR)|0.7982946||||0.139|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.139
71704795|NCT04053452|142927690|OTHER|Vagus|Odds Ratio (OR)|0.9330042||||0.622|TWO_SIDED||||||Regression, Logistic|||Null hypothesis: Nerve ultrasound measurement has no effect on the log-odds of having autonomic dysfunction (i.e., higher ultrasound measurements do not predict whether a subject has autonomic dysfunction during their hospitalization).||||0.622
71825607|NCT01018511|143155655|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.319|TWO_SIDED|95.0|-0.7|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.7|0.319
71704796|NCT04053452|142927691|OTHER|Median at wrist, 3 months|Kendall's tau correlation coefficient|0.2641183|||||TWO_SIDED|95.0|-0.2344|0.7511||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.7511|-0.2344|
71704797|NCT04053452|142927691|OTHER|Median at forearm, 3 months|Kendall's tau correlation coefficient|0.02596308|||||TWO_SIDED|95.0|-0.4859|0.5555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.5555|-0.4859|
71704798|NCT04053452|142927691|OTHER|Median at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.05162687|||||TWO_SIDED|95.0|-0.3342|0.417||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4170|-0.3342|
71704799|NCT04053452|142927691|OTHER|Median at humerus, 3 months|Kendall's tau correlation coefficient|-0.1714461|||||TWO_SIDED|95.0|-0.6473|0.2723||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.2723|-0.6473|
71704800|NCT04053452|142927691|OTHER|Median at axilla, 3 months|Kendall's tau correlation coefficient|-0.0531775|||||TWO_SIDED|95.0|-0.583|0.4451||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4451|-0.5830|
71704801|NCT04053452|142927691|OTHER|Ulnar at wrist, 3 months|Kendall's tau correlation coefficient|0.1371924|||||TWO_SIDED|95.0|-0.3592|0.6944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6944|-0.3592|
71825608|NCT01018511|143155655|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.5|-0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.6|-1.5|< 0.001
71825609|NCT01018511|143155655|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.7|< 0.001
71825610|NCT01018511|143155655|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.4|-0.4||No adjustments to multiplicity were made|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.4|-1.4|< 0.001
71825611|NCT01018511|143155656|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.591|TWO_SIDED|95.0|-0.3|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.5|-0.3|0.591
71825612|NCT01018511|143155656|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.102|TWO_SIDED|95.0|-0.1|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.1|0.102
71653164|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|31.5|||<|0.0001|TWO_SIDED|95.0|18.8|44.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.3|18.8|<0.0001
71653165|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|47.6|||<|0.0001|TWO_SIDED|95.0|35.7|59.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.6|35.7|<0.0001
71653166|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|48.7|||<|0.0001|TWO_SIDED|95.0|37.2|60.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.1|37.2|<0.0001
71653167|NCT03575871|142824793|SUPERIORITY||Difference in Percentage|60.1|||<|0.0001|TWO_SIDED|95.0|49.1|71.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.0|49.1|<0.0001
71653168|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|2.5||||0.1623|TWO_SIDED|95.0|-1.7|6.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.8|-1.7|0.1623
71653169|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|9.1||||0.007|TWO_SIDED|95.0|3.4|14.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||14.7|3.4|0.0070
71653170|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|9.7||||0.0049|TWO_SIDED|95.0|4.0|15.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.4|4.0|0.0049
71653171|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|22.9|||<|0.0001|TWO_SIDED|95.0|15.5|30.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.2|15.5|<0.0001
71653172|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|14.6||||0.0013|TWO_SIDED|95.0|7.2|22.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.0|7.2|0.0013
71653173|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|23.1|40.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.1|23.1|<0.0001
71653174|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|20.1||||0.0001|TWO_SIDED|95.0|11.9|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|11.9|0.0001
71653175|NCT03575871|142824794|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|24.6|42.5|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.6|<0.0001
71653176|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.7|3.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.7|-3.7|
71704802|NCT04053452|142927691|OTHER|Ulnar at forearm, 3 months|Kendall's tau correlation coefficient|-0.0134595|||||TWO_SIDED|95.0|-0.5145|0.4627||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4627|-0.5145|
71704803|NCT04053452|142927691|OTHER|Ulnar at cubital fossa, 3 months|Kendall's tau correlation coefficient|0.01313517|||||TWO_SIDED|95.0|-0.5056|0.4833||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4833|-0.5056|
71704804|NCT04053452|142927691|OTHER|Ulnar at humerus, 3 months|Kendall's tau correlation coefficient|-0.1196495|||||TWO_SIDED|95.0|-0.5876|0.3467||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3467|-0.5876|
71704805|NCT04053452|142927691|OTHER|Ulnar at axilla, 3 months|Kendall's tau correlation coefficient|0.0|||||TWO_SIDED|95.0|-0.3682|0.3885||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.3885|-0.3682|
71704806|NCT04053452|142927691|OTHER|C6, 3 months|Kendall's tau correlation coefficient|0.1194695|||||TWO_SIDED|95.0|-0.422|0.6686||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.6686|-0.4220|
71704807|NCT04053452|142927691|OTHER|C7, 3 months|Kendall's tau correlation coefficient|-0.0593456|||||TWO_SIDED|95.0|-0.5651|0.454||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.4540|-0.5651|
71704808|NCT04053452|142927691|OTHER|Vagus, 3 months|Kendall's tau correlation coefficient|-0.1920694|||||TWO_SIDED|95.0|-0.549|0.238||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 3 months after enrollment.||0.238|-0.5490|
71704809|NCT04053452|142927691|OTHER|Median at wrist, 6 months|Kendall's tau correlation coefficient|0.3150905|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
71704810|NCT04053452|142927691|OTHER|Median at forearm, 6 months|Kendall's tau correlation coefficient|0.1203751|||||TWO_SIDED|||||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||||
71704811|NCT04053452|142927691|OTHER|Median at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2526605|||||TWO_SIDED|95.0|-0.1865|0.643||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6430|-0.1865|
71704812|NCT04053452|142927691|OTHER|Median at humerus, 6 months|Kendall's tau correlation coefficient|-0.073601|||||TWO_SIDED|95.0|-0.5806|0.4223||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.4223|-0.5806|
71763497|NCT00669409|143028814|SUPERIORITY_OR_OTHER_LEGACY||Least Mean Square Difference|-35.1|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-56.4|-13.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-13.8|-56.4|
71763498|NCT00669409|143028815|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.2|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.2|
71763499|NCT00669409|143028815|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-33.0|-0.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-33.0|
71704813|NCT04053452|142927691|OTHER|Median at axilla, 6 months|Kendall's tau correlation coefficient|0.01369735|||||TWO_SIDED|95.0|-0.5619|0.5236||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5236|-0.5619|
71704814|NCT04053452|142927691|OTHER|Ulnar at wrist, 6 months|Kendall's tau correlation coefficient|0.2685663|||||TWO_SIDED|95.0|-0.2488|0.7683||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7683|-0.2488|
71704815|NCT04053452|142927691|OTHER|Ulnar at forearm, 6 months|Kendall's tau correlation coefficient|0.1802776|||||TWO_SIDED|95.0|-0.2573|0.6027||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6027|-0.2573|
71704816|NCT04053452|142927691|OTHER|Ulnar at cubital fossa, 6 months|Kendall's tau correlation coefficient|0.2571327|||||TWO_SIDED|95.0|-0.2595|0.6227||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.6227|-0.2595|
71704817|NCT04053452|142927691|OTHER|Ulnar at humerus, 6 months|Kendall's tau correlation coefficient|-0.0684867|||||TWO_SIDED|95.0|-0.5757|0.3944||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3944|-0.5757|
71704818|NCT04053452|142927691|OTHER|Ulnar at axilla, 6 months|Kendall's tau correlation coefficient|0.1929429|||||TWO_SIDED|95.0|-0.1828|0.555||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5550|-0.1828|
71704819|NCT04053452|142927691|OTHER|C6, 6 months|Kendall's tau correlation coefficient|0.1975146|||||TWO_SIDED|95.0|-0.3557|0.7344||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.7344|-0.3557|
71704820|NCT04053452|142927691|OTHER|C7, 6 months|Kendall's tau correlation coefficient|-0.0754722|||||TWO_SIDED|95.0|-0.615|0.5083||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.5083|-0.6150|
71704821|NCT04053452|142927691|OTHER|Vagus, 6 months|Kendall's tau correlation coefficient|-0.0706753|||||TWO_SIDED|95.0|-0.5042|0.3963||||||Null hypothesis: There is no correlation between nerve ultrasound measurements and GBS Disability score at 6 months after enrollment.||0.3963|-0.5042|
71704822|NCT02734147|142927725|OTHER|||||||0.631|||||||Other|||||||0.631
71704823|NCT02734147|142927726|OTHER|||||||0.64|||||||Other|||||||0.640
71704824|NCT02734147|142927727|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71704825|NCT02734147|142927728|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
71704826|NCT02734147|142927729|SUPERIORITY|||||||0.133|||||||Fisher Exact|||||||0.133
71704827|NCT02734147|142927730|OTHER|||||||0.566|||||||Other|||||||0.566
71704828|NCT02734147|142927731|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71704829|NCT04098302|142927749|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
71704830|NCT04098302|142927750|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|||||||0.019
71704831|NCT04098302|142927751|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71775003|NCT00145600|143050146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4807||95.0|||||Wilcoxon signed rank test|||||||0.4807
71704832|NCT04098302|142927752|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
71704833|NCT01810952|142927753|SUPERIORITY_OR_OTHER|||||||0.35||||||This is the p-value for Day 5|t-test, 2 sided|||||||0.35
71704834|NCT01810952|142927754|SUPERIORITY_OR_OTHER|||||||0.65|||||||Chi-squared|||||||0.65
71704835|NCT01810952|142927755|SUPERIORITY_OR_OTHER|||||||0.06||||||Comparison of the 5 day averages resulted in a p-value of 0.06.|t-test, 2 sided|||Daily values for each protocol were compared using t-tests.||||0.06
71704836|NCT01810952|142927756|SUPERIORITY_OR_OTHER||difference in binomial proportions|||||0.795||||||Comparison of the number of participants in each group with glucose value \<70 mg/dL resulted in p-value 0.795.|Chi-squared|||||||0.795
71704837|NCT01810952|142927757|SUPERIORITY_OR_OTHER|||||||0.055||||||Comparison between groups of percent of glucose values \>180 mg/dL.|Chi-squared|||Values in each group were compared by Chi squared.||||0.055
71704838|NCT01668537|142927779|NON_INFERIORITY|The non-inferiority margin to show that the FD formulation is non-inferior to the LF formulation in terms of ELISA GMTs at the peak visit (Week 6) was predefined as '1.5' for the GMT ratio (LF/FD). Non-inferiority is demonstrated if the upper 95% CI of the GMT ratio (LF/FD) is entirely below 1.5|GMT ratio (LF/FD)|0.796|||||TWO_SIDED|95.0|0.707|0.896||||||||0.896|0.707|
71763500|NCT00669409|143028815|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-13.5|19.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.1|-13.5|
71763501|NCT00669409|143028815|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-29.2|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.2|
71763502|NCT00669409|143028815|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-32.8|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-32.8|
71763503|NCT00669409|143028816|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-22.9|10.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.1|-22.9|
71763504|NCT00669409|143028816|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.7|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.7|
71763505|NCT00669409|143028816|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.0|17.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.6|-15.0|
71763506|NCT00669409|143028816|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-27.1|5.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-27.1|
71763507|NCT00669409|143028816|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-26.0|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-26.0|
71704839|NCT05064800|142927797|OTHER||Ratio of Adjusted Geometric Means|233.06|||||TWO_SIDED|90.0|172.14|315.54|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||315.54|172.14|
71704840|NCT05064800|142927798|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
71704841|NCT05064800|142927799|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 2 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
71704842|NCT05064800|142927800|OTHER||Ratio of Adjusted Geometric Means|171.91|||||TWO_SIDED|90.0|127.51|231.77|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed Cmax of dabigatran was analyzed using mixed effect model with treatment, period, sequence as fixed effects; participant within sequence as a random effect. Estimates of the adjusted mean differences(AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||231.77|127.51|
71704843|NCT05064800|142927801|OTHER||Ratio of Adjusted Geometric Means|169.07|||||TWO_SIDED|90.0|135.25|211.35|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUCinf of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||211.35|135.25|
71763508|NCT00669409|143028817|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-21.1|11.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.9|-21.1|
71775004|NCT00145600|143050146|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.36|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71704844|NCT05064800|142927802|OTHER||Ratio of Adjusted Geometric Means|160.05|||||TWO_SIDED|90.0|119.19|214.9|||Mixed Models Analysis|||Treatment 1 was Reference and Treatment 3 was Test. Natural log-transformed AUClast of dabigatran was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences(AMD)(Test-Reference) and 90%CIs were obtained from the model.The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means(Test/Reference) and 90%CI for the ratios.||214.90|119.19|
71704845|NCT04477486|142927817|SUPERIORITY|Comparing against a historical reference of 12.5% CRR.|||||<|0.001|||||||Exact Binomial Distribution|||||||<0.001
71704846|NCT03461861|142927870|SUPERIORITY||Median Difference (Final Values)|-0.083|STANDARD_DEVIATION|0.0056||0.007567|TWO_SIDED|95.0|-0.0886|-0.0774|||t-test, 2 sided|||The null hypothesis (H0) of this superiority trials asserts that there is no true difference in functional connectivity between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||-0.0774|-0.0886|0.007567
71704847|NCT03461861|142927871|SUPERIORITY||Mean Difference (Final Values)|3.12|STANDARD_DEVIATION|1.4||0.900593|TWO_SIDED|95.0|1.72|4.52|||t-test, 2 sided|||The null hypothesis (H0) of this trial asserts that there is no true difference in AVLT between the interventions of placebo and AGB101, and the alternative hypothesis (H1) states that there is a difference between the interventions of placebo and AGB101. A type I error is the error of rejecting H0 when it is actually true.||4.52|1.72|0.900593
71704848|NCT01501513|142927897|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71704849|NCT01245751|142927942|NON_INFERIORITY_OR_EQUIVALENCE|Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is \>0.67|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.97|1.15||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||Week 6 analysis||1.15|0.97|<0.001
71704850|NCT01245751|142927943|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.54|||<|0.001|TWO_SIDED|95.0|1.44|1.66||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age||A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is \>1.0.||1.66|1.44|<0.001
71704851|NCT05788328|142927945|OTHER||Ratio of Adjusted Geometric Means|86.5|||||TWO_SIDED|90.0|66.05|113.29|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||113.29|66.05|
71704852|NCT05788328|142927945|OTHER||Ratio of Adjusted Geometric Means|82.64|||||TWO_SIDED|90.0|63.1|108.24|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||108.24|63.10|
71704853|NCT05788328|142927946|OTHER||Ratio of Adjusted Geometric Means|85.65|||||TWO_SIDED|90.0|64.96|112.94|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||112.94|64.96|
71704854|NCT05788328|142927946|OTHER||Ratio of Adjusted Geometric Means|80.81|||||TWO_SIDED|90.0|61.28|106.55|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||106.55|61.28|
71704855|NCT05788328|142927947|OTHER||Ratio of Adjusted Geometric Means|229.11|||||TWO_SIDED|90.0|185.23|283.37|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||283.37|185.23|
71704856|NCT05788328|142927947|OTHER||Ratio of Adjusted Geometric Means|214.73|||||TWO_SIDED|90.0|173.38|265.94|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||265.94|173.38|
71704857|NCT05788328|142927948|OTHER||Ratio of Adjusted Geometric Means|213.05|||||TWO_SIDED|90.0|170.46|266.29|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||266.29|170.46|
71738894|NCT04038567|142990621|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-5.6|5.56||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||5.56|-5.60|
71775005|NCT00145600|143050146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824||95.0|||||Wilcoxon signed rank test|||||||0.0824
71738895|NCT04038567|142990622|SUPERIORITY||Mean Difference (Final Values)|3.18|||||TWO_SIDED|95.0|-3.01|9.37||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||9.37|-3.01|
71738896|NCT04038567|142990622|SUPERIORITY||Mean Difference (Final Values)|1.28|||||TWO_SIDED|95.0|-4.92|7.47||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||7.47|-4.92|
71704858|NCT05788328|142927948|OTHER||Ratio of Adjusted Geometric Means|232.32|||||TWO_SIDED|90.0|185.88|290.38|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||290.38|185.88|
71704859|NCT05788328|142927956|OTHER||Ratio of Adjusted Geometric Means|45.25|||||TWO_SIDED|90.0|33.97|60.27|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||60.27|33.97|
71704860|NCT05788328|142927956|OTHER||Ratio of Adjusted Geometric Means|47.44|||||TWO_SIDED|90.0|35.62|63.19|||||Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 240mg QD + DE 150mg (Period 7). Ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||63.19|35.62|
71704861|NCT05788328|142927961|OTHER||Ratio of Adjusted Geometric Means|176.39|||||TWO_SIDED|90.0|135.51|229.6|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 80 mg QD+rosuvastatin 10 mg (Period 5). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||229.60|135.51|
71704862|NCT05788328|142927961|OTHER||Ratio of Adjusted Geometric Means|221.62|||||TWO_SIDED|90.0|170.26|288.48|||||Ratio was of test to reference of adjusted geometric means. The reference arm was rosuvastatin 10 mg (Period 2) and test arm was PF-07081532 240 mg QD+rosuvastatin 10 mg (Period 8). The ratios (and 90% CIs) were expressed as percentages.|Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.||288.48|170.26|
71704863|NCT02357485|142927977|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.004
71704864|NCT02357485|142927978|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Baseline vs 1 year Post-treatment|t-test, 2 sided|||||||<0.001
71704865|NCT02357485|142927979|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
71704866|NCT02357485|142927980|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71704867|NCT02802865|142927997|SUPERIORITY||Rate ratio|1.8||||0.007|TWO_SIDED|95.0|1.18|2.75|||Chi-squared, Corrected|||||2.75|1.18|0.007
71704868|NCT02802865|142927998|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71704869|NCT02802865|142927999|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71704870|NCT02802865|142928000|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71763509|NCT00669409|143028817|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.9|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-35.9|
71763510|NCT00669409|143028817|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-20.4|12.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.2|-20.4|
71763511|NCT00669409|143028817|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.0|2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.3|-30.0|
71763512|NCT00669409|143028817|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.8|-6.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.2|-48.8|
71704871|NCT02802865|142928001|SUPERIORITY|||||||0.709|||||||Chi-squared|||This study was not powered to detect significant between-group differences for this conception.||||0.709
71704872|NCT02802865|142928002|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for clinical pregnancy.||||0.356
71704873|NCT02802865|142928004|SUPERIORITY|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for live birth.||||0.356
71704874|NCT02802865|142928005|SUPERIORITY|||||||0.486|||||||Chi-squared, Corrected|||This study was not powered to detect significant between-group differences for pregnancy loss.||||0.486
71704875|NCT01454063|142928013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.577|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001||95.0|0.475|0.678||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS - Placebo) adjusted for randomization strata.||||0.678|0.475|<0.0001
71704876|NCT01454063|142928014|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.199|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001||95.0|-7.307|-3.091||p-value based on the generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302-placebo) adjusted for randomization strata.||||-3.091|-7.307|<0.0001
71704877|NCT01454063|142928015|SUPERIORITY_OR_OTHER|||||||0.0514||||||Treatment comparisons based on CMH test adjusting for randomization strata.|Cochran-Mantel-Haenszel|||||||0.0514
71704878|NCT01454063|142928016|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparisons based on CMH test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0034
71704879|NCT01454063|142928017|SUPERIORITY_OR_OTHER|||||||0.0963||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata. For subjects without a score due to inability to read the ETDRS chart, the log score will be imputed as 1.6 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.0963
71704880|NCT01454063|142928018|SUPERIORITY_OR_OTHER|||||||0.0532||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0532
71704881|NCT01454063|142928019|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||<0.0001
71704882|NCT03055195|142928031|OTHER||Proportions Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.|||23.3|-1.1|
71704883|NCT03055195|142928033|OTHER||Proportion Difference|-1.0|||||TWO_SIDED|90.0|-14.0|12.6|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.|||12.6|-14.0|
71704884|NCT03055195|142928033|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.|||23.3|-1.1|
71704885|NCT03055195|142928033|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.|||23.3|-1.1|
71704886|NCT03055195|142928033|OTHER||Proportion Difference|11.0|||||TWO_SIDED|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.|||23.3|-1.1|
71704887|NCT03055195|142928033|OTHER||Proportion Difference|6.0|||||TWO_SIDED|90.0|-3.3|14.4|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.|||14.4|-3.3|
71704888|NCT01960842|142928056|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.78|-3.5|||One-sample t-test, 2-sided|||||-3.50|-5.78|<0.001
71704889|NCT01960842|142928057|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.58|||<|0.001|TWO_SIDED|95.0|4.21|6.95|||One-sample t-test, 2-sided|||||6.95|4.21|<0.001
71704890|NCT01960842|142928058|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0|||<|0.001|TWO_SIDED|95.0|-16.3|-7.7|||One-sample t-test, 2-sided|||||-7.7|-16.3|<0.001
71704891|NCT01960842|142928059|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.1|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
71704892|NCT01960842|142928060|SUPERIORITY_OR_OTHER||Mean change from score = 4|-2.0|STANDARD_DEVIATION|0.94|<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).||||<0.001
71704893|NCT01960842|142928061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|||=|0.101|TWO_SIDED|95.0|-4.0|0.4|||One-sample t-test, 2-sided|||||0.4|-4.0|=0.101
71704894|NCT01960842|142928062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1|||=|0.182|TWO_SIDED|95.0|-5.3|1.1|||One-sample t-test, 2-sided|||||1.1|-5.3|=0.182
71704895|NCT01960842|142928063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.9|-0.09|||One-sample t-test, 2-sided|||||-0.09|-1.90|=0.032
71704896|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.2|||<|0.001|TWO_SIDED|95.0|-27.8|-10.6|||One-sample t-test, 2-sided|||Mobility Domain analysis.||-10.6|-27.8|<0.001
71763513|NCT00669409|143028818|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-19.6|13.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.4|-19.6|
71763514|NCT00669409|143028818|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-35.8|-3.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.1|-35.8|
71763515|NCT00669409|143028818|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.4|7.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.4|
71775006|NCT00145600|143050146|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71704897|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|||=|0.059|TWO_SIDED|95.0|-13.3|0.3|||One-sample t-test, 2-sided|||Emotional Well-Being Domain analysis.||0.3|-13.3|=0.059
71704898|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|||=|0.07|TWO_SIDED|95.0|-15.6|0.6|||One-sample t-test, 2-sided|||Stigma Domain analysis.||0.6|-15.6|=0.070
71704899|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5|||=|0.591|TWO_SIDED|95.0|-7.3|4.2|||One-sample t-test, 2-sided|||Social Support Domain analysis.||4.2|-7.3|=0.591
71704900|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.7|-7.3|||One-sample t-test, 2-sided|||Cognition Domain analysis.||-7.3|-20.7|<0.001
71704901|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||=|0.67|TWO_SIDED|95.0|-4.2|6.4|||One-sample t-test, 2-sided|||Communication Domain analysis.||6.4|-4.2|=0.670
71704902|NCT01960842|142928064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|||<|0.001|TWO_SIDED|95.0|-25.2|-10.3|||One-sample t-test, 2-sided|||Bodily Discomfort Domain analysis.||-10.3|-25.2|<0.001
71704903|NCT01960842|142928065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|||=|0.056|TWO_SIDED|95.0|-9.8|0.1|||One-sample t-test, 2-sided|||||0.1|-9.8|=0.056
71704904|NCT01960842|142928066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||=|0.011|TWO_SIDED|95.0|-1.6|-0.2|||One-sample t-test, 2-sided|||||-0.2|-1.6|=0.011
71704905|NCT01960842|142928067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-1.9|||One-sample t-test, 2-sided|||||-1.9|-4.4|<0.001
71704906|NCT01960842|142928068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.65|||<|0.001|TWO_SIDED|95.0|-5.83|-3.47|||One-sample t-test, 2-sided|||||-3.47|-5.83|<0.001
71704907|NCT01960842|142928069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.58|||<|0.001|TWO_SIDED|95.0|-5.73|-3.44|||One-sample t-test, 2-sided|||||-3.44|-5.73|<0.001
71704908|NCT02391584|142928078|SUPERIORITY||||||<|0.0001||||||p\<0.025 was considered significant.|t-test, 1 sided|||||||<0.0001
71704909|NCT02391584|142928082|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71704910|NCT02391584|142928083|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71704911|NCT02391584|142928084|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71704912|NCT02391584|142928085|SUPERIORITY||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value \<0.05 was considered significant.|Mixed Models Analysis|||||||<0.0001
71704913|NCT03737032|142928102|SUPERIORITY|||||||0.8|||||||ANOVA|||Null hypothesis: post-TBS dmPFC activation will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.80
71704914|NCT03737032|142928103|SUPERIORITY|||||||0.23|||||||ANOVA|Repeated measures ANOVA with time (pre or post), condition (cTBS, iTBS, sham TBS), and time\*condition effects.||Null hypothesis: pre-post change in positive affect will not vary by TBS condition. This is tested using the interaction of time\*condition in a repeated measures model.||||0.23
71653177|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|1.3||||0.3261|TWO_SIDED|95.0|-2.8|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.8|0.3261
71653178|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-2.7|0.3207
71653179|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|3.9||||0.081|TWO_SIDED|95.0|-0.8|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.8|0.0810
71704915|NCT03737032|142928104|SUPERIORITY|||||||0.84|||||||ANOVA|||Null hypothesis: post-TBS functional connectivity between the dmPFC and ventral striatum (VS) will not vary by TBS condition. This is tested using the main effect of condition in a repeated measures model.||||0.84
71775007|NCT00145600|143050146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0496||95.0|||||Wilcoxon signed rank test|||||||0.0496
71653180|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|1.3||||0.3207|TWO_SIDED|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-2.7|0.3207
71653181|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|3.8||||0.081|TWO_SIDED|95.0|-0.7|8.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.4|-0.7|0.0810
71704916|NCT00976391|142928106|NON_INFERIORITY_OR_EQUIVALENCE|P-value from a one-sided t-test to test whether the difference of least square means (albiglutide - preprandial lispro insulin) is less than or equal to the pre-specified non-inferiority margin of 0.4%|Mean Difference (Net)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.32|0.0|||t-test, 1 sided|||||0.00|-0.32|<0.0001
71704917|NCT00927186|142928120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The pre-specified significance level 0.05 was used.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704918|NCT00927186|142928121|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71775008|NCT00145600|143050146|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775009|NCT00145600|143050147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0|||||Wilcoxon signed rank test|||||||0.0157
71775010|NCT00145600|143050147|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775011|NCT00145600|143050147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon signed rank test|||||||0.0014
71775012|NCT00145600|143050147|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775013|NCT00145600|143050147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1478||95.0|||||Wilcoxon signed rank test|||||||0.1478
71775014|NCT00145600|143050147|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.56|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775015|NCT00145600|143050148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831||95.0|||||Wilcoxon signed rank test|||||||0.0831
71775016|NCT00145600|143050148|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.25||||0.0027||95.0|||||Spearman Correlation Coefficients|||||||0.0027
71775017|NCT00145600|143050148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0135||95.0|||||Wilcoxon signed rank test|||||||0.0135
71775018|NCT00145600|143050148|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.27||||0.0024||95.0|||||Spearman Correlation Coefficients|||||||0.0024
71775019|NCT00145600|143050148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9848||95.0|||||Wilcoxon signed rank test|||||||0.9848
71775020|NCT00145600|143050148|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.16||||0.0974||95.0|||||Spearman Correlation Coefficients|||||||0.0974
71775021|NCT00145600|143050149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon signed rank test|||||||0.0040
71775022|NCT00145600|143050149|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775023|NCT00145600|143050149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon signed rank test|||||||0.0012
71775024|NCT00145600|143050149|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775025|NCT00145600|143050149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8108||95.0|||||Wilcoxon signed rank test|||||||0.8108
71775026|NCT00145600|143050149|SUPERIORITY_OR_OTHER_LEGACY||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients|||||||<0.0001
71775027|NCT00145600|143050150|SUPERIORITY_OR_OTHER_LEGACY||KM Event-free survival estimate|0.874|||||TWO_SIDED|95.0|0.805|0.944||||||||0.944|0.805|
71775028|NCT00145600|143050150|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.844|||||TWO_SIDED|95.0|0.739|0.95||||||||0.950|0.739|
71775029|NCT00145600|143050150|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.667|||||TWO_SIDED|95.0|0.4|0.933||||||||0.933|0.400|
71775030|NCT00145600|143050150|SUPERIORITY_OR_OTHER_LEGACY||KM event-free survival estimate|0.785|||||TWO_SIDED|95.0|0.716|0.853||||||||0.853|0.716|
71775031|NCT02600351|143050162|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.|Difference in percentages|-18.8||||0.065|TWO_SIDED|95.0|-40.7|3.2|||Cochran-Mantel-Haenszel|||||3.2|-40.7|0.065
71825613|NCT01018511|143155656|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.204|TWO_SIDED|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.6|0.204
71825614|NCT01018511|143155656|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.936|TWO_SIDED|95.0|-0.4|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-0.4|0.936
71825615|NCT01018511|143155656|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.081|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.8|0.081
71825616|NCT01018511|143155657|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.24||0.511|TWO_SIDED|95.0|-0.3|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.3|0.511
71653182|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|5.2||||0.0419|TWO_SIDED|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.1|0.3|0.0419
71653183|NCT03575871|142824795|SUPERIORITY||Difference in Percentage|7.0||||0.018|TWO_SIDED|95.0|1.8|12.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.2|1.8|0.0180
71653184|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-30.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-22.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-22.3|-38.1|<0.0001
71653185|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-42.3|||<|0.0001|TWO_SIDED|95.0|-50.3|-34.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-34.4|-50.3|<0.0001
71653186|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-29.9|||<|0.0001|TWO_SIDED|95.0|-38.1|-21.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.7|-38.1|<0.0001
71653187|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-44.6|||<|0.0001|TWO_SIDED|95.0|-52.8|-36.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.3|-52.8|<0.0001
71653188|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-36.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-36.2|<0.0001
71653189|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-40.2|||<|0.0001|TWO_SIDED|95.0|-50.0|-30.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-30.4|-50.0|<0.0001
71704919|NCT00927186|142928122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704920|NCT00927186|142928122|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71704921|NCT00927186|142928123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704922|NCT00927186|142928123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704923|NCT00927186|142928124|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71704924|NCT00927186|142928124|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71704925|NCT00927186|142928125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704926|NCT00927186|142928125|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704927|NCT00927186|142928125|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71704928|NCT00927186|142928125|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71704929|NCT00927186|142928126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704930|NCT00927186|142928126|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704931|NCT00927186|142928127|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71704932|NCT00927186|142928127|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.002
71763516|NCT00669409|143028818|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.8|-0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.5|-32.8|
71704933|NCT00927186|142928128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704934|NCT00927186|142928128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704935|NCT00927186|142928128|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
71704936|NCT00927186|142928128|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71763517|NCT00669409|143028818|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.9|-11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.4|-53.9|
71763518|NCT00669409|143028819|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-20.1|12.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.9|-20.1|
71763519|NCT00669409|143028819|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.9|-5.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.2|-37.9|
71763520|NCT00669409|143028819|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-25.7|6.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.9|-25.7|
71763521|NCT00669409|143028819|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-31.5|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-31.5|
71763522|NCT00669409|143028819|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-53.7|-11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-11.2|-53.7|
71704937|NCT00927186|142928129|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704938|NCT00927186|142928129|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71763523|NCT00669409|143028820|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-17.0|16.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.0|-17.0|
71763524|NCT00669409|143028820|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-21.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-37.6|-4.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-37.6|
71763525|NCT00669409|143028820|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.1|8.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.5|-24.1|
71763526|NCT00669409|143028820|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-32.2|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.2|
71763527|NCT00669409|143028820|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-48.1|-5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-5.5|-48.1|
71763528|NCT00669409|143028821|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-12.8|20.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.2|-12.8|
71825617|NCT01018511|143155657|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.182|TWO_SIDED|95.0|-0.2|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.8|-0.2|0.182
71704939|NCT00927186|142928130|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.020
71704940|NCT00927186|142928130|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.005
71704941|NCT00927186|142928131|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704942|NCT00927186|142928131|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704943|NCT00927186|142928131|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
71704944|NCT00927186|142928131|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.025
71704945|NCT00927186|142928132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704946|NCT00927186|142928132|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704947|NCT00927186|142928133|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.050
71704948|NCT00927186|142928133|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.016
71704949|NCT00927186|142928134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704950|NCT00927186|142928134|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704951|NCT00927186|142928134|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
71704952|NCT00927186|142928134|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.003
71704953|NCT00927186|142928135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704954|NCT00927186|142928135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704955|NCT00927186|142928136|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
71704956|NCT00927186|142928136|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
71704957|NCT00927186|142928137|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.049
71704958|NCT00927186|142928137|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704959|NCT00927186|142928137|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
71763529|NCT00669409|143028821|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-34.8|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-34.8|
71763530|NCT00669409|143028821|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-21.7|11.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.0|-21.7|
71763531|NCT00669409|143028821|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-30.1|2.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.1|-30.1|
71704960|NCT00927186|142928137|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.196
71763532|NCT00669409|143028821|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-46.0|-3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.5|-46.0|
71704961|NCT00927186|142928138|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.502
71704962|NCT00927186|142928138|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.597
71704963|NCT00927186|142928139|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.077
71704964|NCT00927186|142928139|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.358
71763533|NCT00669409|143028822|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.5|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.5|
71763534|NCT00669409|143028822|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.0|0.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.6|-32.0|
71763535|NCT00669409|143028822|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.7|15.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.9|-16.7|
71704965|NCT00927186|142928140|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.647
71704966|NCT00927186|142928140|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.120
71704967|NCT00927186|142928140|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
71704968|NCT00927186|142928140|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||1.00
71704969|NCT00927186|142928141|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704970|NCT00927186|142928141|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||<0.001
71704971|NCT00927186|142928142|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||1.00
71704972|NCT00927186|142928142|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.198
71704973|NCT00927186|142928143|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.022
71704974|NCT00927186|142928143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704975|NCT00927186|142928143|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.151
71704976|NCT00927186|142928143|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.139
71704977|NCT00927186|142928144|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.154
71704978|NCT00927186|142928144|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.052
71763536|NCT00669409|143028822|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-25.5|6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.7|-25.5|
71763537|NCT00669409|143028822|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-42.0|0.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.5|-42.0|
71763538|NCT00669409|143028823|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-8.4|24.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.6|-8.4|
71763539|NCT00669409|143028823|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-32.6|0.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.0|-32.6|
71763540|NCT00669409|143028823|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-17.1|15.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-17.1|
71763541|NCT00669409|143028823|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-24.4|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-24.4|
71763542|NCT00669409|143028823|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-38.0|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-38.0|
71763543|NCT00669409|143028824|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|8.8|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.7|25.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.3|-7.7|
71763544|NCT00669409|143028824|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-29.2|3.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.5|-29.2|
71763545|NCT00669409|143028824|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-15.8|16.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.8|-15.8|
71763546|NCT00669409|143028824|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.6|8.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.6|-23.6|
71763547|NCT00669409|143028824|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.0|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-37.0|
71763548|NCT00669409|143028825|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-7.4|25.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||25.5|-7.4|
71704979|NCT00927186|142928145|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.906
71704980|NCT00927186|142928145|SUPERIORITY_OR_OTHER|||||||0.159||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)|||||||0.159
71704981|NCT00927186|142928146|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.979
71704982|NCT00927186|142928146|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.002
71704983|NCT00927186|142928146|SUPERIORITY_OR_OTHER|||||||0.695||95.0||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.695
71704984|NCT00927186|142928146|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.853
71704985|NCT00927186|142928147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704986|NCT00927186|142928147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704987|NCT00927186|142928148|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.006
71704988|NCT00927186|142928148|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)|||||||0.001
71763549|NCT00669409|143028825|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-27.1|5.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.5|-27.1|
71763550|NCT00669409|143028825|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-16.9|15.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.7|-16.9|
71763551|NCT00669409|143028825|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|8.14|||TWO_SIDED|95.0|-23.9|8.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.4|-23.9|
71763552|NCT00669409|143028825|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.8|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-37.1|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-37.1|
71704989|NCT00927186|142928149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for sLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704990|NCT00927186|142928149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for dLS/BS at 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71704991|NCT00927186|142928149|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for sLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.004
71763553|NCT00669409|143028826|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.4|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|95.0|-5.1|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.1|
71763554|NCT00669409|143028826|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-24.4|8.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-24.4|
71763555|NCT00669409|143028826|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|8.25|||TWO_SIDED|95.0|-14.2|18.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.4|-14.2|
71763556|NCT00669409|143028826|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-24.3|8.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.0|-24.3|
71763557|NCT00669409|143028826|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|10.75|||TWO_SIDED|95.0|-27.6|14.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.9|-27.6|
71763558|NCT00669409|143028827|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-21.6|11.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.8|-21.6|
71825618|NCT01018511|143155657|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.552|TWO_SIDED|95.0|-0.6|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.6|0.552
71825619|NCT01018511|143155657|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.891|TWO_SIDED|95.0|-0.4|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo||0.5|-0.4|0.891
71825620|NCT01018511|143155657|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.215|TWO_SIDED|95.0|-0.8|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.8|0.215
71763559|NCT00669409|143028827|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
71763560|NCT00669409|143028827|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-21.8|11.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-21.8|
71825621|NCT01018511|143155658|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.383|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||0.1|-0.2|0.383
71704992|NCT00927186|142928149|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for dLS/BS at 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
71704993|NCT00927186|142928150|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||<0.001
71704994|NCT00927186|142928151|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact|||||||0.033
71704995|NCT00927186|142928152|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 6 months."|Fisher Exact|||||||<0.001
71704996|NCT00927186|142928152|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 24 months."|Fisher Exact|||||||0.009
71704997|NCT00927186|142928153|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71704998|NCT00927186|142928154|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.906
71763561|NCT00669409|143028827|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.6|1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.2|-31.6|
71763562|NCT00669409|143028827|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-40.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-62.6|-19.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-19.0|-62.6|
71763563|NCT00669409|143028828|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.9|12.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.5|-20.9|
71825622|NCT01018511|143155658|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.402|TWO_SIDED|95.0|-0.1|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.1|0.402
71825623|NCT01018511|143155658|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.0|-0.3|0.021
71825624|NCT01018511|143155658|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.584|TWO_SIDED|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-0.2|0.584
71704999|NCT00927186|142928155|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.536
71705000|NCT00927186|142928155|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.896
71705001|NCT00927186|142928156|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705002|NCT00927186|142928157|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71705003|NCT00927186|142928158|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705004|NCT00927186|142928159|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.008
71763564|NCT00669409|143028828|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.6|0.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.7|-32.6|
71763565|NCT00669409|143028828|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
71825625|NCT01018511|143155658|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.166|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.166
71653190|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.1|-19.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-19.7|-43.1|<0.0001
71763566|NCT00669409|143028828|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.4|4.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.5|-28.4|
71763567|NCT00669409|143028828|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-38.8|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-38.8|
71763568|NCT00669409|143028829|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-22.2|11.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.2|-22.2|
71653191|NCT03575871|142824796|SUPERIORITY||Difference in LS mean|-44.7|||<|0.0001|TWO_SIDED|95.0|-56.4|-33.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-33.0|-56.4|<0.0001
71705005|NCT00927186|142928160|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71705006|NCT00927186|142928160|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.006
71705007|NCT00927186|142928161|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705008|NCT00927186|142928162|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
71705009|NCT00927186|142928163|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71705010|NCT00927186|142928163|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.039
71705011|NCT00927186|142928164|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
71705012|NCT00927186|142928165|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.079
71705013|NCT00927186|142928166|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.027
71705014|NCT00927186|142928166|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.268
71705015|NCT00927186|142928167|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705016|NCT00927186|142928168|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.025
71705017|NCT00927186|142928169|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)|||||||0.012
71705018|NCT00927186|142928169|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)|||||||0.092
71705019|NCT00927186|142928170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
71705020|NCT00927186|142928170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
71705021|NCT00927186|142928170|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
71705022|NCT00927186|142928171|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71705023|NCT00927186|142928172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
71705024|NCT00927186|142928172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
71705025|NCT00927186|142928172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
71763569|NCT00669409|143028829|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.1|-2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-36.1|
71763570|NCT00669409|143028829|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-15.6|17.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.7|-15.6|
71705026|NCT00927186|142928173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71705027|NCT00927186|142928174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 1 month.|t-test, 2 sided|||||||<0.001
71705028|NCT00927186|142928174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 3 months.|t-test, 2 sided|||||||<0.001
71705029|NCT00927186|142928174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for change from baseline at 6 months.|t-test, 2 sided|||||||<0.001
71705030|NCT00927186|142928175|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71705031|NCT01145222|142928176|SUPERIORITY|Overall comparison between remimazolam and midazolam||||||0.007|||||||Fisher Exact|||||||0.007
71705032|NCT01421134|142928179|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-10.2|-4.8|||Mixed Models Analysis|||||-4.8|-10.2|<0.0001
71705033|NCT01421134|142928180|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-0.96|-0.34|||Mixed Models Analysis|||||-0.34|-0.96|<0.0001
71705034|NCT01421134|142928181|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.1|-1.1|||Mixed Models Analysis|||||-1.1|-3.1|<0.0001
71705035|NCT01421134|142928182|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.2|-2.4|||ANCOVA|||||-2.4|-7.2|0.0001
71763571|NCT00669409|143028829|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-28.0|4.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.8|-28.0|
71763572|NCT00669409|143028829|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-30.1|13.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.5|-30.1|
71825626|NCT01018511|143155659|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.187
71705036|NCT01421134|142928183|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.1|-2.9|||ANCOVA|||||-2.9|-6.1|<0.0001
71705037|NCT01421134|142928184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.615|||<|0.0001|TWO_SIDED|95.0|3.251|13.459|||Regression, Logistic||Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.|||13.459|3.251|<0.0001
71705038|NCT01421134|142928185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.27|||<|0.0001|TWO_SIDED|95.0|2.105|8.663|||Regression, Logistic|||||8.663|2.105|<0.0001
71705039|NCT01543503|142928236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.851|||<|0.001|TWO_SIDED|95.0|-1.112|-0.589|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.589|-1.112|<0.001
71705040|NCT01543503|142928237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||<|0.001|TWO_SIDED|95.0|-1.204|-0.617|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an ANCOVA model with change from baseline to 12 months in DAS28-ESR as dependent variable; therapy and treatment as fixed effects; DAS28-ESR at baseline as covariates.||-0.617|-1.204|<0.001
71705041|NCT01543503|142928238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.23|||<|0.001|TWO_SIDED|95.0|-15.513|-10.947|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in ESR as a dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-10.947|-15.513|<0.001
71705042|NCT01543503|142928238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.648|||<|0.001|TWO_SIDED|95.0|-15.419|-9.876|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in ESR, as the dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.||-9.876|-15.419|<0.001
71705043|NCT01543503|142928239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.673|||<|0.001|TWO_SIDED|95.0|-10.271|-3.074|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CRP as a dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||-3.074|-10.271|<0.001
71705044|NCT01543503|142928239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.116||||0.659|TWO_SIDED|95.0|-6.074|3.842|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CRP as the dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.||3.842|-6.074|0.659
71705045|NCT01543503|142928240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.024|TWO_SIDED|95.0|-1.078|-0.075|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SJC as the dependent variable; therapy and treatment as fixed effects; SJC at baseline as the covariate.||-0.075|-1.078|0.024
71705046|NCT01543503|142928240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.752||||0.002|TWO_SIDED|95.0|-1.238|-0.267|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SJC, as the dependent variable; therapy and treatment as fixed effects; SJC, at baseline as the covariate.||-0.267|-1.238|0.002
71705047|NCT01543503|142928241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.123|TWO_SIDED|95.0|-1.408|0.169|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||0.169|-1.408|0.123
71825627|NCT01018511|143155659|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.203|TWO_SIDED|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-1.0|0.203
71705048|NCT01543503|142928241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.216||||0.004|TWO_SIDED|95.0|-2.039|-0.393|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.||-0.393|-2.039|0.004
71705049|NCT01543503|142928242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.475|||<|0.001|TWO_SIDED|95.0|-5.481|-1.469|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CDAI the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-1.469|-5.481|<0.001
71705050|NCT01543503|142928242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6|||<|0.001|TWO_SIDED|95.0|-6.708|-2.492|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CDAI as the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.||-2.492|-6.708|<0.001
71763573|NCT00669409|143028830|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-20.6|12.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.8|-20.6|
71825628|NCT01018511|143155659|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.09|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.090
71825629|NCT01018511|143155659|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.098|TWO_SIDED|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.1|-1.1|0.098
71825630|NCT01018511|143155659|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.772|TWO_SIDED|95.0|-0.7|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.5|-0.7|0.772
71825631|NCT01018511|143155660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.21|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-0.9|0.210
71705051|NCT01543503|142928242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.229||||0.014|TWO_SIDED|95.0|-5.806|-0.652|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.652|-5.806|0.014
71825632|NCT01018511|143155660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.775|TWO_SIDED|95.0|-0.5|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.6|-0.5|0.775
71825633|NCT01018511|143155660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.01|TWO_SIDED|95.0|-1.2|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-1.2|0.010
71825634|NCT01018511|143155660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.317|TWO_SIDED|95.0|-0.8|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.3|-0.8|0.317
71705052|NCT01543503|142928242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.245||||0.027|TWO_SIDED|95.0|-6.121|-0.37|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.||-0.370|-6.121|0.027
71705053|NCT01543503|142928243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.03|||<|0.001|TWO_SIDED|95.0|-12.655|-5.404|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-5.404|-12.655|<0.001
71825635|NCT01018511|143155660|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.196|TWO_SIDED|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.2|-0.9|0.196
71825636|NCT01018511|143155661|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.009|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.9|0.009
71825637|NCT01018511|143155661|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.045|TWO_SIDED|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.8|0.045
71825638|NCT01018511|143155661|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.7|-1.4|< 0.001
71825639|NCT01018511|143155661|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.1|-0.9|0.011
71825640|NCT01018511|143155661|SUPERIORITY_OR_OTHER_LEGACY||Least squares men difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.5|-1.3|< 0.001
71825641|NCT01018511|143155662|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.5|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.1|-0.5|0.008
71825642|NCT01018511|143155662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.021|TWO_SIDED|95.0|-0.4|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.0|-0.4|0.021
71825643|NCT01018511|143155662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
71825644|NCT01018511|143155662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-0.2|-0.6|< 0.001
71825645|NCT01018511|143155662|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.139|TWO_SIDED|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.0|-0.3|0.139
71825646|NCT01018511|143155664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.14||0.068|TWO_SIDED|95.0|-4.3|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||0.2|-4.3|0.068
71825647|NCT01018511|143155664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.7|STANDARD_DEVIATION|1.15||0.02|TWO_SIDED|95.0|-4.9|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||-0.4|-4.9|0.020
71825648|NCT01018511|143155664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||-2.5|-6.9|< 0.001
71825649|NCT01018511|143155664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-7.5|-3.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||-3.1|-7.5|< 0.001
71653192|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-17.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.5|-35.5|<0.0001
71653193|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-34.1|||<|0.0001|TWO_SIDED|95.0|-43.1|-25.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-25.1|-43.1|<0.0001
71653194|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-29.7|||<|0.0001|TWO_SIDED|95.0|-39.0|-20.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-20.4|-39.0|<0.0001
71653195|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-40.5|||<|0.0001|TWO_SIDED|95.0|-49.8|-31.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-31.1|-49.8|<0.0001
71825650|NCT01018511|143155664|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.14||0.022|TWO_SIDED|95.0|-4.8|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||0.4|-4.8|0.022
71825651|NCT01018511|143155665|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.16||0.011|TWO_SIDED|95.0|0.7|5.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.||5.2|0.7|0.011
71825652|NCT01018511|143155665|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|1.17||0.035|TWO_SIDED|95.0|0.2|4.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.8|0.2|0.035
71825653|NCT01018511|143155665|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|2.8|7.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||7.3|2.8|< 0.001
71825654|NCT01018511|143155665|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.6|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.3|6.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.8|2.3|< 0.001
71825655|NCT01018511|143155665|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.16||0.068|TWO_SIDED|95.0|-0.2|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.4|-0.2|0.068
71825656|NCT01018511|143155666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.07||0.013|TWO_SIDED|95.0|0.5|4.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.7|0.5|0.013
71825657|NCT01018511|143155666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.08||0.043|TWO_SIDED|95.0|0.1|4.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.3|0.1|0.043
71653196|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.6|-21.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-21.2|-44.6|<0.0001
71653197|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-40.6|||<|0.0001|TWO_SIDED|95.0|-52.2|-28.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-28.9|-52.2|<0.0001
71653198|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-39.6|||<|0.0001|TWO_SIDED|95.0|-51.8|-27.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-27.4|-51.8|<0.0001
71653199|NCT03575871|142824797|SUPERIORITY||Difference in LS mean|-48.2|||<|0.0001|TWO_SIDED|95.0|-60.4|-36.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-36.0|-60.4|<0.0001
71825658|NCT01018511|143155666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|2.4|6.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.5|2.4|< 0.001
71825659|NCT01018511|143155666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.9|6.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||6.1|1.9|< 0.001
71825660|NCT01018511|143155666|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.06||0.092|TWO_SIDED|95.0|-0.3|3.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.9|-0.3|0.092
71825661|NCT01018511|143155667|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|1.21||0.011|TWO_SIDED|95.0|0.7|5.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||5.5|0.7|0.011
71825662|NCT01018511|143155667|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.314|TWO_SIDED|95.0|-1.2|3.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.6|-1.2|0.314
71653200|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|1.9||||0.2353|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2353
71653201|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|5.8||||0.0332|TWO_SIDED|95.0|0.8|10.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.8|0.8|0.0332
71653202|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|6.5||||0.0227|TWO_SIDED|95.0|1.4|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.4|0.0227
71705054|NCT01543503|142928243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.237|||<|0.001|TWO_SIDED|95.0|-14.13|-6.345|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.||-6.345|-14.130|<0.001
71705055|NCT01543503|142928247|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71705056|NCT01543503|142928251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.02|TWO_SIDED|95.0|-0.269|-0.024|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.024|-0.269|0.020
71705057|NCT01543503|142928251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.02|TWO_SIDED|95.0|-0.301|-0.026|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.||-0.026|-0.301|0.020
71705058|NCT01543503|142928252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.893||||0.032|TWO_SIDED|95.0|-7.457|-0.329|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||-0.329|-7.457|0.032
71705059|NCT01543503|142928252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.787||||0.168|TWO_SIDED|95.0|-6.763|1.189|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.||1.189|-6.763|0.168
71705060|NCT01543503|142928253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.661||||0.009|TWO_SIDED|95.0|-9.912|-1.411|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-1.411|-9.912|0.009
71705061|NCT01543503|142928253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.802|||<|0.001|TWO_SIDED|95.0|-14.245|-5.36|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in participant's VAS score as dependent variable; therapy and treatment as fixed effects; participant's VAS score at baseline as covariates.||-5.360|-14.245|<0.001
71705062|NCT01543503|142928255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.108||||0.01|TWO_SIDED|95.0|-9.017|-1.2|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-1.200|-9.017|0.010
71705063|NCT01543503|142928255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.767|||<|0.001|TWO_SIDED|95.0|-12.161|-3.372|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Patient's Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient's Global Assessment of Disease at baseline as covariates.||-3.372|-12.161|<0.001
71763574|NCT00669409|143028830|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.6|-2.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.3|-35.6|
71705064|NCT00986583|142928259|SUPERIORITY_OR_OTHER||Ratio of medians|1.34||||0.018|TWO_SIDED|95.0|1.05|1.72||This is for the primary comparison at 20 minute|ANCOVA||Ratio of medians of myoglobin measured at 20 minute for statin users vs. non-statin users|||1.72|1.05|0.018
71705065|NCT03767894|142928283|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|1.36||||0.24|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device).||||0.24
71705066|NCT03767894|142928283|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|-1.72||||0.207|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|t-test, 2 sided|Adjustment for p-value is 2.||Post Unassisted condition (ARAT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (ARAT performed assisted with the use of the MyHand device).||||0.207
71705067|NCT03767894|142928284|OTHER|Descriptive analysis (paired sample t-test)|Mean Difference (Final Values)|2.64||||0.026|TWO_SIDED|||||a priori threshold: p\<0.05|Paired sample T-test|2-tailed||Baseline scores compared to Post Unassisted condition (UEMF performed unassisted/without the use of the MyHand device).||||0.026
71705068|NCT03767894|142928286|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.09||||0.442|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Baseline scores compared to Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) of the impaired (hemiparetic) hand.||||0.442
71763575|NCT00669409|143028830|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-19.6|13.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.7|-19.6|
71763576|NCT00669409|143028830|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-30.9|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-30.9|
71825663|NCT01018511|143155667|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.19||0.003|TWO_SIDED|95.0|1.2|5.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.9|1.2|0.003
71705069|NCT03767894|142928286|OTHER|Descriptive analysis (paired Wilcoxon)|Mean Difference (Final Values)|-1.0||||1|TWO_SIDED|||||a priori threshold: p\<0.05 p-value is adjusted for multiple comparisons using Bonferroni correction.|Wilcoxon (Mann-Whitney)|Adjustment for p-value is 2.||Post Unassisted condition (BBT performed unassisted/without the use of the MyHand device) compared to Post Assisted condition (BBT performed assisted with the use of the MyHand device).||||1.0
71705070|NCT00137280|142928344|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.47|3.58|||Regression, Logistic||Comparison group is the control (denominator)|||3.58|1.47|<0.01
71705071|NCT00137280|142928345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.02|STANDARD_ERROR_OF_MEAN|5.93||0.03|||||||ANCOVA|||||||.03
71705072|NCT00137280|142928346|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.01|TWO_SIDED|95.0|1.22|4.34|||Regression, Logistic||Comparison group is the control (denominator)|||4.34|1.22|<0.01
71705073|NCT00137280|142928347|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||||||.11
71705074|NCT05001165|142928348|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.1|0.7|||Regression, Linear|||||0.7|-0.1|
71705075|NCT05001165|142928349|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.84|2.14|||Regression, Logistic|||||2.14|0.84|
71705076|NCT05001165|142928350|SUPERIORITY||Odds Ratio (OR)|1.06|||<|0.05|TWO_SIDED|95.0|0.64|1.76|||Regression, Logistic|||||1.76|0.64|<0.05
71705077|NCT05001165|142928351|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93|||Regression, Logistic|||||1.93|0.73|
71825664|NCT01018511|143155667|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.21||0.161|TWO_SIDED|95.0|-0.7|4.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.1|-0.7|0.161
71825665|NCT01018511|143155667|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|1.21||0.708|TWO_SIDED|95.0|-1.9|2.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.8|-1.9|0.708
71825666|NCT01018511|143155668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.83||0.043|TWO_SIDED|95.0|0.1|3.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.3|0.1|0.043
71705078|NCT05001165|142928352|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.68|2.05|||Regression, Logistic|||||2.05|0.68|
71705079|NCT05001165|142928353|SUPERIORITY||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.88|2.51|||Regression, Logistic|||||2.51|0.88|
71705080|NCT05001165|142928354|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|0.99|3.64|||Regression, Logistic|||||3.64|0.99|
71705081|NCT05001165|142928355|SUPERIORITY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.34|1.33|||Regression, Logistic|||||1.33|0.34|
71886541|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.0|=|0.754|TWO_SIDED|95.0|-4.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||3.3|-4.6|=0.7540
71705082|NCT04000724|142928360|SUPERIORITY||Average treatment effect|-0.54||||0.141|TWO_SIDED|95.0|-1.26|0.18|||Longitudinal Targeted Maximum Likelihood|||||0.18|-1.26|0.141
71705083|NCT04000724|142928360|SUPERIORITY||Average treatment effect|-0.51||||0.123|TWO_SIDED|95.0|-1.16|0.14|||Longitudinal Targeted Maximum Likelihood|||||0.14|-1.16|0.123
71705084|NCT04000724|142928361|SUPERIORITY||Average treatment effect|-0.24||||0.127|TWO_SIDED|95.0|-0.56|0.07|||Longitudinal Targeted Maximum Likelihood|||||.07|-.56|.127
71705085|NCT04000724|142928361|SUPERIORITY||Average treatment effect|-0.02||||0.899|TWO_SIDED|95.0|-0.34|0.3|||Longitudinal Targeted Maximum Likelihood|||||.30|-.34|.899
71705086|NCT02187055|142928409|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-7.73||||0.2101|TWO_SIDED|98.34|-16.29|0.83|||Normal approximation to proportions|Multiplicity-adjusted||||0.83|-16.29|0.2101
71705087|NCT02187055|142928409|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-5.5||||0.0512|TWO_SIDED|98.34|-13.98|2.98|||Normal approximation to proportions|Multiplicity-adjusted||||2.98|-13.98|0.0512
71705088|NCT02187055|142928409|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|2.23|||<|0.0001|TWO_SIDED|98.34|-6.4|10.86|||Normal approximation to proportions|Multiplicity adjusted||||10.86|-6.40|<0.0001
71705089|NCT02187055|142928410|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||||TWO_SIDED|95.0|1.23|4.41||||||||4.41|1.23|
71705090|NCT02187055|142928410|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.33|3.49||||||||3.49|0.33|
71705091|NCT02187055|142928410|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.51|0.68||||||||0.68|-2.51|
71705092|NCT02187055|142928411|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|1.08|4.18||||||||4.18|1.08|
71705093|NCT02187055|142928411|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|0.4|3.48||||||||3.48|0.40|
71705094|NCT02187055|142928411|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.24|0.86||||||||0.86|-2.24|
71705095|NCT02187055|142928412|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.16|0.5||||||||0.50|0.16|
71705096|NCT02187055|142928412|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|0.05|0.39||||||||0.39|0.05|
71705097|NCT02187055|142928412|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.28|0.06||||||||0.06|-0.28|
71705098|NCT02187055|142928413|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.15|0.51||||||||0.51|0.15|
71825667|NCT01018511|143155668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.84||0.12|TWO_SIDED|95.0|-0.3|3.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.0|-0.3|0.120
71825668|NCT01018511|143155668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.82||0.003|TWO_SIDED|95.0|0.8|4.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||4.0|0.8|0.003
71653203|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|16.8||||0.0001|TWO_SIDED|95.0|10.1|23.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.5|10.1|0.0001
71653204|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|14.5||||0.0008|TWO_SIDED|95.0|7.7|21.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.3|7.7|0.0008
71653205|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|25.8|||<|0.0001|TWO_SIDED|95.0|18.1|33.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.4|18.1|<0.0001
71653206|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|18.5||||0.0003|TWO_SIDED|95.0|10.5|26.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||26.5|10.5|0.0003
71653207|NCT03575871|142824798|SUPERIORITY||Difference in Percentage|30.2|||<|0.0001|TWO_SIDED|95.0|21.4|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.4|<0.0001
71653208|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|12.7||||0.0011|TWO_SIDED|95.0|6.5|18.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.9|6.5|0.0011
71653209|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.6|40.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||40.6|24.6|<0.0001
71705099|NCT02187055|142928413|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.1|0.46||||||||0.46|0.10|
71705100|NCT02187055|142928413|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.23|0.13||||||||0.13|-0.23|
71705101|NCT02187055|142928414|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.21|||||TWO_SIDED|95.0|-4.99|2.56||||||||2.56|-4.99|
71705102|NCT02187055|142928414|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.78|||||TWO_SIDED|95.0|-5.59|2.04||||||||2.04|-5.59|
71705103|NCT02187055|142928414|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.56|||||TWO_SIDED|95.0|-4.53|3.4||||||||3.40|-4.53|
71705104|NCT02187055|142928415|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.4|||||TWO_SIDED|95.0|-7.95|1.15||||||||1.15|-7.95|
71705105|NCT02187055|142928415|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.55|1.43||||||||1.43|-7.55|
71705106|NCT02187055|142928415|SUPERIORITY_OR_OTHER||Difference in remission rate|0.34|||||TWO_SIDED|95.0|-4.45|5.14||||||||5.14|-4.45|
71705107|NCT02187055|142928416|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.67|||||TWO_SIDED|95.0|-8.29|0.94||||||||0.94|-8.29|
71705108|NCT02187055|142928416|SUPERIORITY_OR_OTHER||Difference in remission rate|-3.06|||||TWO_SIDED|95.0|-7.59|1.48||||||||1.48|-7.59|
71705109|NCT02187055|142928416|SUPERIORITY_OR_OTHER||Difference in remission rate|0.62|||||TWO_SIDED|95.0|-4.24|5.47||||||||5.47|-4.24|
71705110|NCT02187055|142928417|SUPERIORITY_OR_OTHER||Difference in remission rate|-1.55|||||TWO_SIDED|95.0|-6.03|2.93||||||||2.93|-6.03|
71705111|NCT02187055|142928417|SUPERIORITY_OR_OTHER||Difference in remission rate|-2.02|||||TWO_SIDED|95.0|-6.51|2.47||||||||2.47|-6.51|
71705112|NCT02187055|142928417|SUPERIORITY_OR_OTHER||Difference in remission rate|-0.47|||||TWO_SIDED|95.0|-5.11|4.18||||||||4.18|-5.11|
71705113|NCT02187055|142928418|SUPERIORITY_OR_OTHER||Difference in remission rate|-9.49|||||TWO_SIDED|95.0|-15.68|-3.3||||||||-3.30|-15.68|
71705114|NCT02187055|142928418|SUPERIORITY_OR_OTHER||Difference in remission rate|-6.89|||||TWO_SIDED|95.0|-12.94|-0.83||||||||-0.83|-12.94|
71705115|NCT02187055|142928418|SUPERIORITY_OR_OTHER||Difference in remission rate|2.61|||||TWO_SIDED|95.0|-3.86|9.07||||||||9.07|-3.86|
71705116|NCT02187055|142928419|SUPERIORITY_OR_OTHER||Difference in response rate|-6.24|||||TWO_SIDED|95.0|-13.32|0.84||||||||0.84|-13.32|
71705117|NCT02187055|142928419|SUPERIORITY_OR_OTHER||Difference in response rate|-3.66|||||TWO_SIDED|95.0|-10.69|3.37||||||||3.37|-10.69|
71705118|NCT02187055|142928419|SUPERIORITY_OR_OTHER||Difference in response rate|2.58|||||TWO_SIDED|95.0|-4.51|9.68||||||||9.68|-4.51|
71705119|NCT02187055|142928420|SUPERIORITY_OR_OTHER||Difference in response rate|-6.22|||||TWO_SIDED|95.0|-13.29|0.85||||||||0.85|-13.29|
71705120|NCT02187055|142928420|SUPERIORITY_OR_OTHER||Difference in response rate|-3.93|||||TWO_SIDED|95.0|-10.94|3.09||||||||3.09|-10.94|
71705121|NCT02187055|142928420|SUPERIORITY_OR_OTHER||Difference in response rate|2.3|||||TWO_SIDED|95.0|-4.79|9.39||||||||9.39|-4.79|
71705122|NCT02187055|142928421|SUPERIORITY_OR_OTHER||Difference in response rate|-6.02|||||TWO_SIDED|95.0|-12.05|0.0||||||||0.00|-12.05|
71825669|NCT01018511|143155668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.83||0.014|TWO_SIDED|95.0|0.4|3.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.||3.7|0.4|0.014
71825670|NCT01018511|143155668|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.83||0.384|TWO_SIDED|95.0|-0.9|2.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||2.4|-0.9|0.384
71825671|NCT01018511|143155669|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.92||0.004|TWO_SIDED|95.0|0.8|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||4.4|0.8|0.004
71825672|NCT01018511|143155669|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|2.0|STANDARD_ERROR_OF_MEAN|0.93||0.035|TWO_SIDED|95.0|0.1|3.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.||3.8|0.1|0.035
71825673|NCT01018511|143155669|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|2.2|5.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.8|2.2|< 0.001
71825674|NCT01018511|143155669|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.5|5.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||5.1|1.5|< 0.001
71825675|NCT01018511|143155669|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.92||0.142|TWO_SIDED|95.0|-0.5|3.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.||3.2|-0.5|0.142
71825676|NCT01018511|143155670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.874|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.874
71825677|NCT01018511|143155670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).||||0.240
71825678|NCT01018511|143155670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.324|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.324
71825679|NCT01018511|143155670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.043
71825680|NCT01018511|143155670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).||||0.407
71825681|NCT01018511|143155677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
71705123|NCT02187055|142928421|SUPERIORITY_OR_OTHER||Difference in response rate|-6.89|||||TWO_SIDED|95.0|-12.9|-0.87||||||||-0.87|-12.90|
71705124|NCT02187055|142928421|SUPERIORITY_OR_OTHER||Difference in response rate|-0.87|||||TWO_SIDED|95.0|-7.17|5.44||||||||5.44|-7.17|
71705125|NCT02187055|142928422|SUPERIORITY_OR_OTHER||Difference in response rate|-4.87|||||TWO_SIDED|95.0|-11.92|2.18||||||||2.18|-11.92|
71705126|NCT02187055|142928422|SUPERIORITY_OR_OTHER||Difference in response rate|-5.48|||||TWO_SIDED|95.0|-12.49|1.52||||||||1.52|-12.49|
71705127|NCT02187055|142928422|SUPERIORITY_OR_OTHER||Difference in rresponse rate|-0.61|||||TWO_SIDED|95.0|-7.7|6.47||||||||6.47|-7.70|
71705128|NCT02187055|142928423|SUPERIORITY_OR_OTHER||Difference in response rate|-8.29|||||TWO_SIDED|95.0|-14.84|-1.75||||||||-1.75|-14.84|
71705129|NCT02187055|142928423|SUPERIORITY_OR_OTHER||Difference in response rate|-6.14|||||TWO_SIDED|95.0|-12.72|0.44||||||||0.44|-12.72|
71825682|NCT01018511|143155677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||<.001
71825683|NCT01018511|143155677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
71825684|NCT01018511|143155677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
71825685|NCT01018511|143155677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.058
71825686|NCT01018511|143155678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.053
71825687|NCT01018511|143155678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.031
71825688|NCT01018511|143155678|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
71825689|NCT01018511|143155678|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
71825690|NCT01018511|143155678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.018
71825691|NCT01018511|143155679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.110
71825692|NCT01018511|143155679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.||||0.071
71825693|NCT01018511|143155679|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
71825694|NCT01018511|143155679|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||<.001
71825695|NCT01018511|143155679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.||||0.019
71653210|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|28.3|||<|0.0001|TWO_SIDED|95.0|18.5|38.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.2|18.5|<0.0001
71705130|NCT02187055|142928423|SUPERIORITY_OR_OTHER||Difference in response rate|2.15|||||TWO_SIDED|95.0|-4.22|8.52||||||||8.52|-4.22|
71705131|NCT02187055|142928424|SUPERIORITY_OR_OTHER||Difference in response rate|-6.77|||||TWO_SIDED|95.0|-12.61|-0.93||||||||-0.93|-12.61|
71705132|NCT02187055|142928424|SUPERIORITY_OR_OTHER||Difference in response rate|-2.5|||||TWO_SIDED|95.0|-8.09|3.1||||||||3.10|-8.09|
71705133|NCT02187055|142928424|SUPERIORITY_OR_OTHER||Difference in response rate|4.27|||||TWO_SIDED|95.0|-1.68|10.23||||||||10.23|-1.68|
71705134|NCT02187055|142928425|SUPERIORITY_OR_OTHER||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.011|0.148||||||||0.148|-0.011|
71705135|NCT02187055|142928425|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.054|0.105||||||||0.105|-0.054|
71705136|NCT02187055|142928425|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|||||TWO_SIDED|95.0|-0.122|0.037||||||||0.037|-0.122|
71763577|NCT00669409|143028830|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-51.2|-7.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-51.2|
71763578|NCT00669409|143028831|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.3|17.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.1|-16.3|
71653211|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|43.2|<0.0001
71653212|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|17.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|17.0|<0.0001
71705137|NCT02187055|142928426|SUPERIORITY_OR_OTHER||Difference in response rate|-4.07|||||TWO_SIDED|95.0|-10.68|2.55||||||||2.55|-10.68|
71705138|NCT02187055|142928426|SUPERIORITY_OR_OTHER||Difference in response rate|-1.21|||||TWO_SIDED|95.0|-7.87|5.44||||||||5.44|-7.87|
71705139|NCT02187055|142928426|SUPERIORITY_OR_OTHER||Difference in response rate|2.86|||||TWO_SIDED|95.0|-3.72|9.43||||||||9.43|-3.72|
71705140|NCT02187055|142928427|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.28|-0.11||||||||-0.11|-2.28|
71705141|NCT02187055|142928427|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.16|0.01||||||||0.01|-2.16|
71705142|NCT02187055|142928427|SUPERIORITY_OR_OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.97|1.2||||||||1.20|-0.97|
71705143|NCT02187055|142928428|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.74|0.85||||||||0.85|-1.74|
71705144|NCT02187055|142928428|SUPERIORITY_OR_OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.48|2.11||||||||2.11|-0.48|
71705145|NCT02187055|142928428|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||||TWO_SIDED|95.0|-0.04|2.56||||||||2.56|-0.04|
71705146|NCT02187055|142928429|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.22|0.39||||||||0.39|-2.22|
71705147|NCT02187055|142928429|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.19|0.42||||||||0.42|-2.19|
71705148|NCT02187055|142928429|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.27|1.34||||||||1.34|-1.27|
71705149|NCT02187055|142928430|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.52|0.87||||||||0.87|-1.52|
71705150|NCT02187055|142928430|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.8|1.58||||||||1.58|-0.80|
71705151|NCT02187055|142928430|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.47|1.91||||||||1.91|-0.47|
71705152|NCT02187055|142928431|SUPERIORITY_OR_OTHER||LS mean difference|-2.0|||||TWO_SIDED|95.0|-3.25|-0.8||||||||-0.80|-3.25|
71705153|NCT02187055|142928431|SUPERIORITY_OR_OTHER||LS mean difference|-1.7|||||TWO_SIDED|95.0|-2.91|-0.47||||||||-0.47|-2.91|
71763579|NCT00669409|143028831|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-35.4|-2.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.2|-35.4|
71705154|NCT02187055|142928431|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.89|1.55||||||||1.55|-0.89|
71705155|NCT02187055|142928432|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|||||TWO_SIDED|95.0|-2.27|-0.05||||||||-0.05|-2.27|
71705156|NCT02187055|142928432|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-1.4|0.82||||||||0.82|-1.40|
71705157|NCT02187055|142928432|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-0.25|1.98||||||||1.98|-0.25|
71705158|NCT02187055|142928433|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|||||TWO_SIDED|95.0|-1.71|0.68||||||||0.68|-1.71|
71705159|NCT02187055|142928433|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.33|1.05||||||||1.05|-1.33|
71705160|NCT02187055|142928433|SUPERIORITY_OR_OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.83|1.57||||||||1.57|-0.83|
71705161|NCT02187055|142928434|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|||||TWO_SIDED|95.0|-2.2|0.45||||||||0.45|-2.20|
71705162|NCT02187055|142928434|SUPERIORITY_OR_OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.13|1.51||||||||1.51|-1.13|
71705163|NCT02187055|142928434|SUPERIORITY_OR_OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.26|2.39||||||||2.39|-0.26|
71763580|NCT00669409|143028831|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.1|9.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.1|-24.1|
71705164|NCT02187055|142928435|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-2.54|0.39||||||||0.39|-2.54|
71825696|NCT01391013|143155763|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.08
71825697|NCT01391013|143155764|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.88
71825698|NCT01391013|143155765|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.31
71825699|NCT01391013|143155766|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.37
71825700|NCT01391013|143155767|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
71705165|NCT02187055|142928435|SUPERIORITY_OR_OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.76|2.16||||||||2.16|-0.76|
71705166|NCT02187055|142928435|SUPERIORITY_OR_OTHER||LS mean difference|1.8|||||TWO_SIDED|95.0|0.3|3.24||||||||3.24|0.30|
71705167|NCT02187055|142928436|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.55|1.08||||||||1.08|-1.55|
71763581|NCT00669409|143028831|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.9|0.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.9|-31.9|
71763582|NCT00669409|143028831|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-53.1|-9.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-9.5|-53.1|
71705168|NCT02187055|142928436|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-1.01|1.62||||||||1.62|-1.01|
71705169|NCT02187055|142928436|SUPERIORITY_OR_OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.78|1.86||||||||1.86|-0.78|
71705170|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-2.279|1.427||||||Work hours missed due to problems||1.427|-2.279|
71705171|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|||||TWO_SIDED|95.0|-2.783|1.044||||||Work hours missed due to problems||1.044|-2.783|
71705172|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||||TWO_SIDED|95.0|-2.349|1.462||||||Work hours missed due to problems||1.462|-2.349|
71705173|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|||||TWO_SIDED|95.0|-2.928|2.346||||||Work hours missed other reason||2.346|-2.928|
71705174|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.9|||||TWO_SIDED|95.0|-1.832|3.64||||||Work hours missed other reason||3.640|-1.832|
71705175|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|-1.52|3.911||||||Work hours missed other reason||3.911|-1.520|
71705176|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|4.95|||||TWO_SIDED|95.0|0.52|9.37||||||Hours worked in past 7 days||9.370|0.520|
71705177|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|2.85|||||TWO_SIDED|90.0|-1.736|7.43||||||Hours worked in past 7 days||7.430|-1.736|
71705178|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-2.1|||||TWO_SIDED|95.0|-6.65|2.454||||||Hours worked in past 7 days||2.454|-6.650|
71705179|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.373|0.786||||||Problems affecting productivity||0.786|-0.373|
71705180|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.578|0.607||||||Problems affecting productivity||0.607|-0.578|
71705181|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.19|||||TWO_SIDED|95.0|-0.784|0.4||||||Problems affecting productivity||0.400|-0.784|
71705182|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.24|||||TWO_SIDED|95.0|-0.112|0.587||||||Problem affecting daily activities||0.587|-0.112|
71705183|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.341|0.357||||||Problem affecting daily activities||0.357|-0.341|
71705184|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|||||TWO_SIDED|95.0|-0.582|0.122||||||Problem affecting daily activities||0.122|-0.582|
71705185|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|||||TWO_SIDED|95.0|-5.748|3.553||||||% work time missed due to health||3.553|-5.748|
71705186|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-2.64|||||TWO_SIDED|95.0|-7.339|2.067||||||% work time missed due to health||2.067|-7.339|
71705187|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-1.54|||||TWO_SIDED|95.0|-6.283|3.207||||||% work time missed due to health||3.207|-6.283|
71763583|NCT00669409|143028832|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-16.9|16.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-16.9|
71825701|NCT01391013|143155768|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.02
71825702|NCT01391013|143155769|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.12
71825703|NCT01391013|143155770|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.71
71825704|NCT01391013|143155771|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.83
71825705|NCT01391013|143155772|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.||||||0.66
71825706|NCT01391013|143155773|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.76
71825707|NCT01391013|143155774|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.56
71825708|NCT01391013|143155775|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.11
71825709|NCT01391013|143155776|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.18
71825710|NCT01391013|143155777|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.03
71825711|NCT01391013|143155778|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Nonparametric Wilcoxon rank sum test|||||||0.04
71825712|NCT00299702|143155790|SUPERIORITY_OR_OTHER|||||||0.684||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Log Rank|Insufficient number of subjects who had an event for median estimation.||Null hypothesis: there is no difference in time to relapse||||0.684
71705188|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||||TWO_SIDED|95.0|-3.726|7.858||||||% impairment while working due to health||7.858|-3.726|
71705189|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.15|||||TWO_SIDED|95.0|-5.777|6.068||||||% impairment while working due to health||6.068|-5.777|
71653213|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|46.1|||<|0.0001|TWO_SIDED|95.0|35.2|57.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||57.1|35.2|<0.0001
71653214|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|36.2|||<|0.0001|TWO_SIDED|95.0|25.4|47.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.1|25.4|<0.0001
71653215|NCT03575871|142824799|SUPERIORITY||Difference in Percentage|49.6|||<|0.0001|TWO_SIDED|95.0|38.9|60.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||60.3|38.9|<0.0001
71653216|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|1.9||||0.2261|TWO_SIDED|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-2.2|0.2261
71653217|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|5.2||||0.0451|TWO_SIDED|95.0|0.3|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.0|0.3|0.0451
71653218|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|7.0||||0.0171|TWO_SIDED|95.0|1.8|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.8|0.0171
71653219|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|17.7|||<|0.0001|TWO_SIDED|95.0|10.9|24.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.5|10.9|<0.0001
71653220|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|11.5||||0.0018|TWO_SIDED|95.0|5.5|17.5||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.5|5.5|0.0018
71653221|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||33.1|18.3|<0.0001
71653222|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|16.2||||0.0005|TWO_SIDED|95.0|8.8|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|8.8|0.0005
71653223|NCT03575871|142824800|SUPERIORITY||Difference in Percentage|27.6|||<|0.0001|TWO_SIDED|95.0|19.3|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|19.3|<0.0001
71653224|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.1|-2.3|<0.0001
71653225|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.3|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.5|<0.0001
71653226|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.3|-2.6|<0.0001
71653227|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-3.1|||<|0.0001|TWO_SIDED|95.0|-3.8|-2.5|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.5|-3.8|<0.0001
71705190|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-7.839|3.998||||||% impairment while working due to health||3.998|-7.839|
71705191|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|2.11|||||TWO_SIDED|95.0|-4.664|8.877||||||% overall work impairment due to health||8.877|-4.664|
71705192|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|95.0|-5.164|8.58||||||% overall work impairment due to health||8.580|-5.164|
71705193|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-7.307|6.51||||||% overall work impairment due to health||6.510|-7.307|
71705194|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||||TWO_SIDED|95.0|-1.118|5.873||||||% activity impairment due to health||5.873|-1.118|
71653228|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
71653229|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.9|-3.3|<0.0001
71653230|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-1.4||||0.0006|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.6|-2.2|0.0006
71653231|NCT03575871|142824801|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.4|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.4|-3.0|<0.0001
71653232|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.8|-2.0|<0.0001
71653233|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.8|-3.0|<0.0001
71653234|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.2|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.2|-2.4|<0.0001
71653235|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-2.3|-3.6|<0.0001
71705195|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|0.08|||||TWO_SIDED|95.0|-3.411|3.573||||||% activity impairment due to health||3.573|-3.411|
71705196|NCT02187055|142928437|SUPERIORITY_OR_OTHER||LS mean difference|-2.3|||||TWO_SIDED|95.0|-5.818|1.225||||||% activity impairment due to health||1.225|-5.818|
71653236|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.9|-2.3|<0.0001
71653237|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.7|-3.1|<0.0001
71653238|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-0.9||||0.0164|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-0.2|-1.7|0.0164
71653239|NCT03575871|142824802|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.||-1.0|-2.5|<0.0001
71653240|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-20.9|||<|0.0001|TWO_SIDED|95.0|-26.6|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-26.6|<0.0001
71653241|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-32.1|||<|0.0001|TWO_SIDED|95.0|-37.9|-26.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.4|-37.9|<0.0001
71653242|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-21.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-15.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.2|-28.1|<0.0001
71653243|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-35.9|||<|0.0001|TWO_SIDED|95.0|-42.3|-29.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-29.4|-42.3|<0.0001
71705197|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.057|0.011||||||Utility score||0.011|-0.057|
71705198|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.054|0.013||||||Utility score||0.013|-0.054|
71705199|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.031|0.036||||||Utility score||0.036|-0.031|
71705200|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|||||TWO_SIDED|95.0|-0.098|0.042||||||Mobility score||0.042|-0.098|
71705201|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.079|0.06||||||Mobility score||0.060|-0.079|
71705202|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.02|||||TWO_SIDED|95.0|-0.051|0.089||||||Mobility score||0.089|-0.051|
71705203|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.014|0.127||||||Self-care score||0.127|-0.014|
71705204|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.027|0.114||||||Self-care score||0.114|-0.027|
71705205|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-0.083|0.058||||||Self-care score||0.058|-0.083|
71705206|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.062|0.084||||||Usual activities score||0.084|-0.062|
71705207|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.06|||||TWO_SIDED|95.0|-0.018|0.129||||||Usual activities score||0.129|-0.018|
71705208|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-0.029|0.118||||||Usual activities score||0.118|-0.029|
71653244|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-19.4|||<|0.0001|TWO_SIDED|95.0|-26.8|-12.1|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-12.1|-26.8|<0.0001
71705209|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
71653245|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-33.6|||<|0.0001|TWO_SIDED|95.0|-41.0|-26.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-26.3|-41.0|<0.0001
71653246|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-23.1|||<|0.0001|TWO_SIDED|95.0|-32.3|-13.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.9|-32.3|<0.0001
71653247|NCT03575871|142824803|SUPERIORITY||Difference in LS mean|-33.4|||<|0.0001|TWO_SIDED|95.0|-42.6|-24.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-24.3|-42.6|<0.0001
71653248|NCT01744093|142824812|OTHER|Descriptive proportion|Proportion (percent)|18.8|||||TWO_SIDED|95.0|4.0|45.6|||||Exact two-sided 95% Clopper-Pearson confidence interval.|||45.6|4.0|
71653249|NCT01744093|142824813|SUPERIORITY||Proportion (percent)|6.3||||0.002|TWO_SIDED|95.0|0.16|30.2|||Fisher Exact||Exact two-sided 95% Clopper-Pearson confidence interval.|Null hypothesis adverse event rate (grade 2 or higher toxicity) = 45.5%||30.2|0.16|0.002
71653250|NCT03998436|142824828|SUPERIORITY||Odds Ratio (OR)|2.126||||0.0276|TWO_SIDED|95.0|1.08|4.17|||Chi-squared|||||4.17|1.08|0.0276
71653251|NCT03998436|142824829|SUPERIORITY||Odds Ratio (OR)|2.708||||0.0126|TWO_SIDED|95.0|1.22|5.99|||Chi-squared|||||5.99|1.22|0.0126
71653252|NCT03095118|142824849|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Proteinuria baseline values compared to 6 month follow up values||||0.001
71653253|NCT03095118|142824850|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Proteinuria baseline values compared to 12 month follow up values||||0.004
71653254|NCT03095118|142824852|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Serum creatinine baseline values compared to 6 month follow up values||||0.15
71653255|NCT03095118|142824853|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Serum creatinine baseline values comparted to 12 month follow up values||||0.16
71653256|NCT02646917|142824875|SUPERIORITY||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||Goodman and Baron's qualitative acne scar severity scores. Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean change from baseline is equal to zero.||||<0.008
71653257|NCT02646917|142824876|SUPERIORITY||||||<|0.001|||||||Wilcoxen signed-rank test|||Null hypothesis 4 (no change).||||<.001
71653258|NCT02646917|142824877|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean change from baseline is equal to zero||||<0.01
71653259|NCT02646917|142824878|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated from Wilcoxon signed-rank test. The testing hypothesis is that the mean score is equal to 0 (no change in the appearance of acne scars).||||<0.01
71653260|NCT02646917|142824879|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Calculated from Wilcoxon signed-rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||||<0.01
71653261|NCT00680186|142824880|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.13||||0.0002||95.0|0.69|1.85||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint|Regression, Cox|Patients without events are censored at the end of ptp.||Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.85|0.69|0.0002
71653262|NCT00680186|142824880|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the RD based on KM estimates|Risk Difference (Percentage)|0.2|||<|0.0001||95.0|-1.0|1.3||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.3|-1.0|<0.0001
71653263|NCT00680186|142824880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||||95.0|0.64|1.8|||Regression, Cox|Patients without events are censored at the earliest of last contact date or day 180.||HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.||1.8|0.64|
71653264|NCT00680186|142824881|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.6932||95.0|-1.1|1.6|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.6|-1.1|0.6932
71825713|NCT00299702|143155791|SUPERIORITY_OR_OTHER|||||||0.646||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in time in remission between the two treatment groups||||0.646
71653265|NCT00680186|142824881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.6383||95.0|0.75|1.6|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.60|0.75|0.6383
71653266|NCT00680186|142824882|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.6||||0.1703||95.0|-0.3|1.5|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.5|-0.3|0.1703
71705210|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.015|0.116||||||Pain/discomfort score||0.116|-0.015|
71653267|NCT00680186|142824882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.1054||95.0|0.9|3.01|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.01|0.90|0.1054
71653268|NCT00680186|142824883|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.4||||0.2283||95.0|-1.1|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.1|0.2283
71653269|NCT00680186|142824883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.2101||95.0|0.26|1.35|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.35|0.26|0.2101
71653270|NCT00680186|142824884|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.2||||0.083||95.0|0.0|0.5|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.5|0.0|0.0830
71653271|NCT00680186|142824885|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.7348||95.0|-0.7|1.0|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.0|-0.7|0.7348
71653272|NCT00680186|142824885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8939||95.0|0.61|1.77|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.77|0.61|0.8939
71653273|NCT00680186|142824886|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.321|TWO_SIDED|95.0|-1.0|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.3|-1.0|0.3210
71653274|NCT00680186|142824886|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.3021|TWO_SIDED|95.0|0.29|1.46|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.29|0.3021
71653275|NCT00680186|142824887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||||95.0|0.36|1.32|||Regression, Cox||This is the analysis of the time to the first MBE.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.32|0.36|
71653276|NCT00680186|142824887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.56|0.81|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.81|0.56|<0.0001
71653277|NCT00285584|142824895|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.5||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
71653278|NCT00285584|142824896|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.5||||0.3|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank test||||0.3
71705211|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.041|0.091||||||Pain/discomfort score||0.091|-0.041|
71705212|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.03|||||TWO_SIDED|95.0|-0.046|0.103||||||Anxiety/depression score||0.103|-0.046|
71705213|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-0.066|0.083||||||Anxiety/depression score||0.083|-0.066|
71705214|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|||||TWO_SIDED|95.0|-0.094|0.055||||||Anxiety/depression score||0.055|-0.094|
71705215|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|-0.14|||||TWO_SIDED|95.0|-2.934|2.648||||||VAS score||2.648|-2.934|
71705216|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|1.23|||||TWO_SIDED|95.0|-1.556|4.016||||||VAS score||4.016|-1.556|
71705217|NCT02187055|142928438|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.425|4.171||||||VAS score||4.171|-1.425|
71825714|NCT05460663|143155796|EQUIVALENCE|Paired Wilcoxon signed ranks tests were used to compare changes at 12-week, 18-week, or 24-week follow-ups from the baseline scores for all measurements in each training modality separately and combined. Comparisons were made with participants who had data at both baseline and the follow-up. Difference-in-difference comparison of changes between two training modalities at each follow-up from the baseline were made to assess differences between CBT and in-person training.||||||0.083||||||The reported P-value is for differences between groups at 24-weeks post-intervention.The Benjamini \& Hochberg adjustment was applied to control for the false-discovery rate among all pairwise pre-post comparisons.|Wilcoxon (Mann-Whitney)|||||||.083
71653279|NCT00285584|142824897|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.15||||0.3|TWO_SIDED|95.0|0.4|27.8|||Fisher Exact|||Comparison of cumulative incidence proportions||27.8|0.4|0.3
71653280|NCT00285584|142824898|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.5||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71653281|NCT00645944|142824903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.039|TWO_SIDED|95.0|-7.5|-0.2|||Mixed Models Analysis|||||-0.2|-7.5|0.039
71653282|NCT01523587|142824917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.814||||0.0103|TWO_SIDED|95.0|0.693|0.956||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.||0.956|0.693|0.0103
71653283|NCT01523587|142824918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.0193|TWO_SIDED|95.0|0.727|0.973||P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.||0.973|0.727|0.0193
71653284|NCT01523587|142824919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.0551|TWO_SIDED|95.0|0.98|4.32||Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.|Regression, Logistic|||||4.32|0.98|0.0551
71653285|NCT01523587|142824920|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002|TWO_SIDED|95.0|1.18|2.06|||Regression, Logistic|Odds ratio (Afatinib vs Erlotinib), 95% CI and p-value (two-sided) from logistic regression stratified by race.||||2.06|1.18|0.0020
71653286|NCT01523587|142824921|SUPERIORITY_OR_OTHER||Adjusted mean|-1.2|STANDARD_ERROR_OF_MEAN|1.77||0.5|TWO_SIDED|95.0|-4.67|2.28|||ANCOVA||Mean was adjusted for baseline sum of diameters and race.|The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.||2.28|-4.67|0.500
71653287|NCT01523587|142824923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2562|TWO_SIDED|95.0|0.72|1.09||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Coughing.||1.09|0.72|0.2562
71653288|NCT01523587|142824923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0078|TWO_SIDED|95.0|0.66|0.94||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Dyspnoea||0.94|0.66|0.0078
71653289|NCT01523587|142824923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.869|TWO_SIDED|95.0|0.82|1.18||p-value calculated using log rank test stratified by race|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Pain||1.18|0.82|0.8690
71653290|NCT01523587|142824924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.34||0.0091|TWO_SIDED|95.0|-6.15|-0.88|||Regression, Cox|||The results shown relate to Change in scores over time for: Coughing.||-0.88|-6.15|0.0091
71653291|NCT01523587|142824924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.15||0.0024|TWO_SIDED|95.0|-5.75|-1.25|||Regression, Cox|||The results shown relate to Change in scores over time for: Dyspnoea.||-1.25|-5.75|0.0024
71653292|NCT01523587|142824924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.32||0.0384|TWO_SIDED|95.0|-5.33|-0.15|||Regression, Cox|||The results shown relate to Change in scores over time for: Pain.||-0.15|-5.33|0.0384
71653293|NCT02709486|142824925|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0088|TWO_SIDED|95.0|-0.81|-0.12||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.81|0.0088
71825715|NCT03820986|143155800|SUPERIORITY|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|0.83||||0.0295||95.0|0.69|1.0|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.00|0.69|0.0295
71825716|NCT03820986|143155801|SUPERIORITY|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by BRAF mutation positive (Yes vs. No).|Hazard Ratio (HR)|1.2||||0.9521|TWO_SIDED|95.0|0.97|1.48|||Log Rank|One-sided p-value based on log-rank test and stratified by BRAF mutation positive (Yes vs. No).|HR=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|||1.48|0.97|0.9521
71825717|NCT03820986|143155806|OTHER||Difference in LS means|-3.69||||0.0345|TWO_SIDED|95.0|-7.1|-0.27|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a constrained longitudinal data analysis (cLDA) model with GHS/QoL as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-0.27|-7.10|0.0345
71825718|NCT03820986|143155807|OTHER||Difference in LS means|-5.49||||0.0004|TWO_SIDED|95.0|-8.53|-2.45|||cLDA model||Difference in LS means=Pembrolizumab + Lenvatinib vs. Pembrolizumab + Placebo|Based on a cLDA model with PF as the response variable, with covariates for treatment by time interaction, stratification factor BRAF mutation status as covariate.||-2.45|-8.53|0.0004
71825719|NCT03820986|143155808|OTHER||Hazard Ratio (HR)|1.58||||0.0001|TWO_SIDED|95.0|1.25|2.0|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown)||2.00|1.25|0.0001
71825720|NCT03820986|143155809|OTHER||Hazard Ratio (HR)|1.95||||0.0001|TWO_SIDED|95.0|1.52|2.5|||Log Rank||HR=Lenvatinib + Pembrolizumab vs. Placebo + Pembrolizumab|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by BRAF mutation status (positive vs wild type or unknown).||2.50|1.52|.0001
71825721|NCT00762463|143155843|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was \<10 mm.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.79||0.0085|TWO_SIDED|95.0|-2.2|8.8|||ANCOVA|Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient's Assessment of Global Pain Intensity score.||"Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was \<10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided)."||8.8|-2.2|0.0085
71653294|NCT02709486|142824925|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.97|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.97|0.0006
71653295|NCT02709486|142824926|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.18||0.0008|TWO_SIDED|95.0|-0.93|-0.24||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-0.93|0.0008
71653296|NCT02709486|142824926|SUPERIORITY|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.36||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.36|-1.05|<.0001
71705218|NCT02187055|142928439|SUPERIORITY_OR_OTHER||LS mean difference|-0.45|||||TWO_SIDED|95.0|-1.706|0.808||||||||0.808|-1.706|
71705219|NCT02187055|142928439|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.178|2.325||||||||2.325|-0.178|
71825722|NCT00762463|143155845|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.5||0.7849|TWO_SIDED|95.0|-5.6|4.2|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||4.2|-5.6|0.7849
71825723|NCT00762463|143155845|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.62||0.3223|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.8|-2.6|0.3223
71825724|NCT00762463|143155847|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8938|TWO_SIDED|95.0|-0.15|0.17|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.17|-0.15|0.8938
71825725|NCT00762463|143155847|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0426|TWO_SIDED|95.0|0.01|0.31|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.31|0.01|0.0426
71825726|NCT00762463|143155847|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1502|TWO_SIDED|95.0|-0.05|0.29|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.29|-0.05|0.1502
71825727|NCT00762463|143155849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.5945|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.1|-0.2|0.5945
71825728|NCT00762463|143155849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3427|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.3427
71825729|NCT00762463|143155849|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6522|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.1|0.6522
71705220|NCT02187055|142928439|SUPERIORITY_OR_OTHER||LS mean difference|1.52|||||TWO_SIDED|95.0|0.266|2.779||||||||2.779|0.266|
71825730|NCT00762463|143155851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9358|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.3|0.9358
71825731|NCT00762463|143155851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5916|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.5916
71825732|NCT00762463|143155851|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.179|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.7|-0.1|0.1790
71705221|NCT03520387|142928441|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-10.2|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.7|-10.2|
71705222|NCT03520387|142928441|SUPERIORITY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-11.0|-1.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||-1.6|-11.0|
71705223|NCT03520387|142928442|SUPERIORITY||Mean Difference (Final Values)|-6059.0|STANDARD_ERROR_OF_MEAN|2832.7|||TWO_SIDED|95.0|-12467.0|349.1|||||This is an analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts. Positive values show increased steps with LRFA over simulated LRFA.|||349.1|-12467.0|
71705224|NCT03520387|142928442|SUPERIORITY||Mean Difference (Final Values)|2081.9|STANDARD_ERROR_OF_MEAN|2983.2|||TWO_SIDED|95.0|-4666.6|8830.4|||||This is an analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts.Positive values show increased steps with AcTIVE-CBT over TBSCE.|||8830.4|-4666.6|
71705225|NCT03520387|142928443|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.2|3.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with LRFA over simulated LRFA.|||3.1|-5.2|
71705226|NCT03520387|142928443|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.2|3.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE.|||3.6|-4.2|
71705227|NCT03520387|142928444|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.1|10.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS physical health scores||10.1|-8.1|
71705228|NCT03520387|142928444|SUPERIORITY||Mean Difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-0.4|12.9|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS physical health scores||12.9|-0.4|
71763584|NCT00669409|143028832|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.7|-3.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.4|-36.7|
71705229|NCT03520387|142928444|SUPERIORITY||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|12.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA.|PROMIS mental health scores||12.7|-5.4|
71705230|NCT03520387|142928444|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-7.0|10.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE|PROMIS mental health scores||10.6|-7.0|
71705231|NCT03520387|142928445|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-7.7|1.9|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with LRFA over simulated LRFA.|||1.9|-7.7|
71705232|NCT03520387|142928445|SUPERIORITY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-7.5|1.0|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with AcTIVE-CBT over TBSCE.|||1.0|-7.5|
71705233|NCT03520387|142928446|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.4|1.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate perceived benefit with LRFA over simulated LRFA.|||1.7|-1.4|
71705234|NCT03520387|142928446|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.3|1.5|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Positive scores indicate perceived benefit with AcTIVE-CBT over TBSCE.|||1.5|-1.3|
71705235|NCT03520387|142928447|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-5.5|3.7|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with LRFA over simulated LRFA.|||3.7|-5.5|
71705236|NCT03520387|142928447|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|95.0|-5.4|2.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with AcTIVE-CBT vs. TBSCE|||2.6|-5.4|
71705237|NCT03520387|142928448|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.5|3.0|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with LRFA over simulated LRFA.|||3.0|-0.5|
71763585|NCT00669409|143028832|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-24.2|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-24.2|
71763586|NCT00669409|143028832|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.4|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.8|3.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.0|-29.8|
71763587|NCT00669409|143028832|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-33.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-55.6|-12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-12.0|-55.6|
71763588|NCT00669409|143028833|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-12.9|20.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.4|-12.9|
71763589|NCT00669409|143028833|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-36.5|-3.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-36.5|
71763590|NCT00669409|143028833|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|10.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-23.3|
71763591|NCT00669409|143028833|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-31.2|1.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-31.2|
71763592|NCT00669409|143028833|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.2|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.0|-6.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.4|-50.0|
71763593|NCT00669409|143028834|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-9.4|24.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||24.0|-9.4|
71763594|NCT00669409|143028834|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-34.4|-1.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.2|-34.4|
71763595|NCT00669409|143028834|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-20.0|13.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.2|-20.0|
71763596|NCT00669409|143028834|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-29.9|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-29.9|
71825733|NCT00762463|143155853|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6335|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.5|-0.3|0.6335
71825734|NCT00762463|143155853|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2729|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.6|-0.2|0.2729
71825735|NCT00762463|143155853|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1559|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.8|-0.1|0.1559
71825736|NCT00762463|143155856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.67||0.1111|TWO_SIDED|95.0|-1.0|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.0|0.1111
71825737|NCT00762463|143155856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.74||0.3574|TWO_SIDED|95.0|-2.9|7.9|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||7.9|-2.9|0.3574
71825738|NCT00762463|143155856|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.76||0.1464|TWO_SIDED|95.0|-1.4|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||9.5|-1.4|0.1464
71825739|NCT00762463|143155858|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9641|TWO_SIDED|95.0|-1.7|1.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||1.8|-1.7|0.9641
71763597|NCT00669409|143028834|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-50.3|-6.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-6.7|-50.3|
71653297|NCT02709486|142824927|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1092|TWO_SIDED|95.0|-0.24|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.24|0.1092
71763598|NCT00669409|143028835|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.3|29.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.1|-4.3|
71653298|NCT02709486|142824927|SUPERIORITY|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0051|TWO_SIDED|95.0|-0.32|-0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.32|0.0051
71653299|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.94|-0.4|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-0.94|<.0001
71653300|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0149|TWO_SIDED|95.0|-0.61|-0.07|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.61|0.0149
71653301|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.08|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.08|<.0001
71705238|NCT03520387|142928448|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.4|2.8|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||2.8|-0.4|
71763599|NCT00669409|143028835|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-31.4|1.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.9|-31.4|
71763600|NCT00669409|143028835|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.6|18.6||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.6|-14.6|
71763601|NCT00669409|143028835|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.6|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-25.0|7.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.8|-25.0|
71763602|NCT00669409|143028835|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.1|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-44.9|-1.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-44.9|
71705239|NCT03520387|142928449|SUPERIORITY||Mean Difference (Final Values)|-637.0|STANDARD_ERROR_OF_MEAN|433.3|||TWO_SIDED|95.0|-1636.2|362.1|||||Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate greater activity with LRFA over simulated LRFA.|||362.1|-1636.2|
71705240|NCT03520387|142928449|SUPERIORITY||Mean Difference (Final Values)|572.2|STANDARD_ERROR_OF_MEAN|334.5|||TWO_SIDED|95.0|-199.3|1343.6|||||Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE.|||1343.6|-199.3|
71705241|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71738897|NCT04038567|142990622|SUPERIORITY||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-6.09|6.3||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||6.30|-6.09|
71763603|NCT00669409|143028836|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.6|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.1|28.3||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.3|-5.1|
71825740|NCT00762463|143155858|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7749|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7749
71825741|NCT00762463|143155858|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7529|TWO_SIDED|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.2|-1.6|0.7529
71763604|NCT00669409|143028836|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-32.1|1.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.1|-32.1|
71763605|NCT00669409|143028836|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.5|19.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||19.7|-13.5|
71738898|NCT04038567|142990629|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.26|-0.13||||||Values are change in model-estimated means for therapist vs. app introduction. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||-0.13|-5.26|
71825742|NCT00762463|143155860|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.878|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.2|-0.2|0.8780
71763606|NCT00669409|143028836|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.1|9.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.7|-23.1|
71763607|NCT00669409|143028836|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.7|2.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.9|-40.7|
71763608|NCT00669409|143028837|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-4.4|29.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.0|-4.4|
71705242|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705243|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71653302|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.07|<.0001
71653303|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.92|<.0001
71653304|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.07|<.0001
71653305|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.05|<.0001
71653306|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.09|<.0001
71653307|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.93|-0.26|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.93|0.0005
71653308|NCT02709486|142824928|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.93|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.93|0.0004
71653309|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.95|-0.42|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-0.95|<.0001
71653310|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.7|-0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.70|0.0014
71653311|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.09|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.09|<.0001
71763609|NCT00669409|143028837|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.2|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-27.8|5.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.8|
71763610|NCT00669409|143028837|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-13.2|20.1||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.1|-13.2|
71763611|NCT00669409|143028837|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.9|9.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-23.9|
71763612|NCT00669409|143028837|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-40.4|3.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.2|-40.4|
71763613|NCT00669409|143028838|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|11.2|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-5.5|27.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||27.9|-5.5|
71763614|NCT00669409|143028838|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.3|7.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.0|-26.3|
71763615|NCT00669409|143028838|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-14.7|18.5||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.5|-14.7|
71763616|NCT00669409|143028838|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-23.6|9.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.2|-23.6|
71763617|NCT00669409|143028838|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-42.2|1.4||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.4|-42.2|
71763618|NCT00669409|143028839|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.5|STANDARD_ERROR_OF_MEAN|8.44|||TWO_SIDED|95.0|-3.2|30.2||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||30.2|-3.2|
71763619|NCT00669409|143028839|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-23.3|9.9||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.3|
71763620|NCT00669409|143028839|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-11.5|21.7||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||21.7|-11.5|
71763621|NCT00669409|143028839|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-24.1|8.8||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.8|-24.1|
71763622|NCT00669409|143028839|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|11.02|||TWO_SIDED|95.0|-31.6|12.0||||||Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-31.6|
71825743|NCT00762463|143155860|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2202|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.1|0.2202
71763623|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-24.7|6.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.4|-24.7|
71825744|NCT00762463|143155860|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.534|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||0.4|-0.2|0.5340
71825745|NCT00762463|143155862|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.81||0.7003|TWO_SIDED|95.0|-4.3|2.9|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.9|-4.3|0.7003
71763624|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-36.0|-4.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-4.9|-36.0|
71763625|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-19.9|11.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.4|-19.9|
71763626|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.9|-0.4||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.4|-30.9|
71763627|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-49.4|-8.9||||||Change at Week 1, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-8.9|-49.4|
71763628|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-16.9|14.3||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.3|-16.9|
71825746|NCT00762463|143155864|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|2.221||0.5183|TWO_SIDED|95.0|-5.82|2.94|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.||2.94|-5.82|0.5183
71825747|NCT01306331|143155869|NON_INFERIORITY|If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.2|3.2||||||The primary hypothesis test was performed using 95% confidence interval for the difference in cumulative pregnancy rates between the treatment arms. If the upper bound for the confidence interval of the difference was \< 5.5, then the null hypothesis would be rejected.||3.2|-2.2|
71825748|NCT04358549|143155902|SUPERIORITY||Median Difference (Final Values)|14.0||||0.0415|TWO_SIDED|90.0|||||Log Rank|||||||0.0415
71825749|NCT04358549|143155903|SUPERIORITY||Odds Ratio (OR)|0.653|||||TWO_SIDED|90.0|0.19|2.24||||||||2.240|0.190|
71825750|NCT04358549|143155904|SUPERIORITY||Median Difference (Final Values)|3.0||||0.9879|TWO_SIDED|90.0|||||Log Rank|||||||0.9879
71825751|NCT00470626|143155944|SUPERIORITY_OR_OTHER||Probability of Successful Retrieval|0.9||||||95.0|||||||Probability of successful retrieval is from Kaplan-Meier analysis.|||||
71825752|NCT02380742|143155948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.02
71825753|NCT02380742|143155949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|0.87||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.||||.03
71825754|NCT02380742|143155950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.811|STANDARD_ERROR_OF_MEAN|0.83||0.03|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.||||.03
71825755|NCT02380742|143155951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.63||0.09|TWO_SIDED||||||ANCOVA|||The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.||||.09
71825756|NCT00151996|143155952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
71825757|NCT00151996|143155952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score||||<0.0001
71653312|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.08|<.0001
71653313|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.93|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-0.93|<.0001
71653314|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.06|<.0001
71653315|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.11|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.11|<.0001
71653316|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.15|<.0001
71738899|NCT04038567|142990629|SUPERIORITY||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.46|0.67||||||Values are change in model-estimated means for high vs. standard dose. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||0.67|-4.46|
71738900|NCT04038567|142990629|SUPERIORITY||Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-3.31|1.83||||||Values are change in model-estimated means for therapist vs. app response. Intervention components are coded as follows: introduction method (therapist \[1\] vs app \[-1\]), dose (high \[1\] vs low \[-1\]), and symptom management (therapist \[1\] vs app \[-1\]).||1.83|-3.31|
71738901|NCT03533244|142990632|SUPERIORITY|||||||0.218||||||To reserve the family-wise error rate, the main treatment effect will be first assessed at the global level at alpha = 0.05. If this is significant, then pairwise comparisons will be conducted using the Bonferroni adjustment for multiplicity.|Mixed Models Analysis|||An empirical sample size estimation was used as this was an exploratory study. The null hypothesis is that there is no difference between AG-86893 and AG-86893 Vehicle. It is expected that the active group is at least 50% better than the vehicle.||||0.218
71825758|NCT00151996|143155954|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||<0.0001
71825759|NCT00151996|143155954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Change from baseline in CPRS-R total score||||0.0002
71825760|NCT00151996|143155956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7004||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.7004
71825761|NCT00151996|143155956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
71653317|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.00|<.0001
71653318|NCT02709486|142824930|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.00|<.0001
71653319|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.33|-0.12|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.12|-0.33|<.0001
71653320|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.0022|TWO_SIDED|95.0|-0.27|-0.06|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.27|0.0022
71653321|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.35|<.0001
71705244|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705245|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71738902|NCT03533244|142990632|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.290
71738903|NCT03533244|142990633|SUPERIORITY|||||||0.193|||||||Mixed Models Analysis|||||||0.193
71738904|NCT03533244|142990633|SUPERIORITY|||||||0.399|||||||Mixed Models Analysis|||||||0.399
71738905|NCT03533244|142990634|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
71738906|NCT03533244|142990634|SUPERIORITY|||||||0.022|||||||Fisher Exact|||||||0.022
71738907|NCT01496846|142990635|SUPERIORITY|||||||0.901|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.901
71738908|NCT01496846|142990635|SUPERIORITY|||||||0.004|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.004
71738909|NCT01496846|142990636|SUPERIORITY|||||||0.437|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.||||||.437
71738910|NCT02024724|142990637|SUPERIORITY||Median Difference (Final Values)|-30.0||||0.196|TWO_SIDED|95.0|-45.0|10.0|||Chi-squared|||||10.00|-45.00|.196
71825762|NCT00151996|143155956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9257||95.0|||||t-test, 2 sided|||Change in physical summary score||||0.9257
71653322|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.43|<.0001
71825763|NCT00151996|143155956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Change in psychosocial summary score||||<0.0001
71653323|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0029|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.28|0.0029
71653324|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.37|<.0001
71653325|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.4|-0.17|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.40|<.0001
71653326|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.43|-0.2|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.43|<.0001
71653327|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0352|TWO_SIDED|95.0|-0.26|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.26|0.0352
71653328|NCT02709486|142824932|SUPERIORITY||Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.37|-0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-0.37|<.0001
71705246|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71738911|NCT02019875|142990660|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.884|TWO_SIDED|95.0|-21.2|18.3|||Mixed Models Analysis|||||18.3|-21.2|0.884
71653329|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.59|3.14|||Regression, Logistic|||Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.59|<.0001
71653330|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0085|TWO_SIDED|95.0|1.12|2.18|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.12|0.0085
71653331|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.0001|TWO_SIDED|95.0|1.89|3.88|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.88|1.89|<.0001
71653332|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.28|1.62|<.0001
71653333|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0005|TWO_SIDED|95.0|1.33|2.75|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.33|0.0005
71738912|NCT02019875|142990660|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.955|TWO_SIDED|95.0|-19.5|20.7|||Mixed Models Analysis|||||20.7|-19.5|0.955
71738913|NCT02019875|142990660|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.53|TWO_SIDED|95.0|-26.5|13.6|||Mixed Models Analysis|||||13.6|-26.5|0.53
71738914|NCT02019875|142990660|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.434|TWO_SIDED|95.0|-27.6|11.9|||Mixed Models Analysis|||||11.9|-27.6|0.434
71738915|NCT02019875|142990660|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.796|TWO_SIDED|95.0|-24.2|18.6|||Mixed Models Analysis|||||18.6|-24.2|0.796
71738916|NCT02019875|142990661|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.62|TWO_SIDED|95.0|-6.0|3.6|||Mixed Models Analysis|||||3.6|-6.0|0.62
71738917|NCT02019875|142990661|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.482|TWO_SIDED|95.0|-3.1|6.7|||Mixed Models Analysis|||||6.7|-3.1|0.482
71705247|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705248|NCT03336866|142928450|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: AUCinf. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705249|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71738918|NCT02019875|142990661|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.559|TWO_SIDED|95.0|-3.4|6.4|||Mixed Models Analysis|||||6.4|-3.4|0.559
71738919|NCT02019875|142990661|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.138|TWO_SIDED|95.0|-1.2|8.5|||Mixed Models Analysis|||||8.5|-1.2|0.138
71738920|NCT02019875|142990661|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.477|TWO_SIDED|95.0|-7.1|3.3|||Mixed Models Analysis|||||3.3|-7.1|0.477
71738921|NCT02019875|142990662|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|-11.0|11.3|||Mixed Models Analysis|||||11.3|-11.0|0.98
71738922|NCT02019875|142990662|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.81|TWO_SIDED|95.0|-10.0|12.7|||Mixed Models Analysis|||||12.7|-10.0|0.81
71738923|NCT02019875|142990662|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.91|TWO_SIDED|95.0|-10.8|12.2|||Mixed Models Analysis|||||12.2|-10.8|0.91
71738924|NCT02019875|142990662|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.68|TWO_SIDED|95.0|-8.9|13.8|||Mixed Models Analysis|||||13.8|-8.9|0.68
71738925|NCT02019875|142990662|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.96|TWO_SIDED|95.0|-11.9|12.6|||Mixed Models Analysis|||||12.6|-11.9|0.96
71738926|NCT02019875|142990663|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.17|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||||0.5|-2.7|0.17
71738927|NCT02019875|142990663|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.44|TWO_SIDED|95.0|-1.0|2.2|||Mixed Models Analysis|||||2.2|-1.0|0.44
71738928|NCT02019875|142990663|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.7|1.6|||Mixed Models Analysis|||||1.6|-1.7|0.94
71738929|NCT02019875|142990663|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||Mixed Models Analysis|||||5.2|2.1|<0.0001
71738930|NCT02019875|142990663|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.2|5.6|||Mixed Models Analysis|||||5.6|2.2|<0.0001
71738931|NCT02019875|142990664|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.43|TWO_SIDED|95.0|-0.027|0.012|||Mixed Models Analysis|||||0.012|-0.027|0.43
71738932|NCT02019875|142990664|SUPERIORITY||Mean Difference (Final Values)|-0.017||||0.09|TWO_SIDED|95.0|-0.037|0.003|||Mixed Models Analysis|||||0.003|-0.037|0.09
71738933|NCT02019875|142990664|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.29|TWO_SIDED|95.0|-0.031|0.009|||Mixed Models Analysis|||||0.009|-0.031|0.29
71738934|NCT02019875|142990664|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.61|TWO_SIDED|95.0|-0.025|0.015|||Mixed Models Analysis|||||0.015|-0.025|0.61
71738935|NCT02019875|142990664|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.46|TWO_SIDED|95.0|-0.03|0.014|||Mixed Models Analysis|||||0.014|-0.03|0.46
71738936|NCT02019875|142990665|SUPERIORITY||Mean Difference (Final Values)|-12.6||||0.53|TWO_SIDED|95.0|-52.0|26.7|||Mixed Models Analysis|||||26.7|-52.0|0.53
71738937|NCT02019875|142990665|SUPERIORITY||Mean Difference (Final Values)|-44.5||||0.03|TWO_SIDED|95.0|-84.5|-4.5|||Mixed Models Analysis|||||-4.5|-84.5|0.03
71738938|NCT02019875|142990665|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.72|TWO_SIDED|95.0|-47.3|32.8|||Mixed Models Analysis|||||32.8|-47.3|0.72
71738939|NCT02019875|142990665|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.89|TWO_SIDED|95.0|-36.6|42.2|||Mixed Models Analysis|||||42.2|-36.6|0.89
71738940|NCT02019875|142990665|SUPERIORITY||Mean Difference (Final Values)|38.0||||0.08|TWO_SIDED|95.0|-4.7|80.6|||Mixed Models Analysis|||||80.6|-4.7|0.08
71738941|NCT02019875|142990666|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-104.5|110.2|||Mixed Models Analysis|||||110.2|-104.5|0.96
71738942|NCT02019875|142990666|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.79|TWO_SIDED|95.0|-94.2|124.2|||Mixed Models Analysis|||||124.2|-94.2|0.79
71738943|NCT02019875|142990666|SUPERIORITY||Mean Difference (Final Values)|71.3||||0.2|TWO_SIDED|95.0|-37.9|180.5|||Mixed Models Analysis|||||180.5|-37.9|0.20
71825764|NCT01729819|143155957|SUPERIORITY|The change in mean nocturnal voids from baseline as the dependent variable, baseline mean nocturnal voids as a covariate, and treatments and visit (Month 1, Month 2, and Month 3) as factors, was considered for the analysis. Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. Missing values post-baseline were not imputed.|Mean Difference (Final Values)|-0.34||||0.112|TWO_SIDED|95.0|-0.77|0.08|||ANCOVA|Change in mean nocturnal voids as the dependent variable and baseline mean nocturnal voids as a covariate, treatment and visit as factors.|Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented. The trial was to be declared positive if a statistically significant (two-sided, p \< 0.05) positive effect for combining tolterodine and desmopressin compared to tolterodine monotherapy on the primary endpoint had been demonstrated.||0.08|-0.77|0.112
71825765|NCT01729819|143155958|SUPERIORITY||Mean Difference (Final Values)|18.0||||0.385|TWO_SIDED|95.0|-22.96|58.96|||ANCOVA|Change in mean time to first void as dependent variable and baseline mean time to first void as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented.||58.96|-22.96|0.385
71825766|NCT01729819|143155959|SUPERIORITY||Mean Difference (Final Values)|-64.16||||0.103|TWO_SIDED|95.0|-141.46|13.14|||ANCOVA|Change in mean nocturnal volume as the dependent variable and baseline mean nocturnal volume as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented||13.14|-141.46|0.103
71825767|NCT01729819|143155960|SUPERIORITY||Odds Ratio (OR)|1.36||||0.352|TWO_SIDED|95.0|0.71|2.62||33% responder status as dependent variable, baseline mean nocturnal voids as covariate, treatment, and visit as factors.|Generalized Estimating Equation|||Combination versus tolterodine (i.e. odds of being responder in combination group versus odds of being responder in tolterodine group) is presented. The proportion of responders during three months of treatment was analysed (i.e. the odds ratio of the odds of being a responder) longitudinally using Generalised Estimating Equation (GEE) for a repeated logistic regression.||2.62|0.71|0.352
71738944|NCT02019875|142990666|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.96|TWO_SIDED|95.0|-110.1|104.7|||Mixed Models Analysis|||||104.7|-110.1|0.96
71738945|NCT02019875|142990666|SUPERIORITY||Mean Difference (Final Values)|51.8||||0.38|TWO_SIDED|95.0|-64.7|168.2|||Mixed Models Analysis|||||168.2|-64.7|0.38
71738946|NCT01278797|142990689|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.51||||0.005||90.0|91.6|97.51|||ANOVA|ANOVA was applied to log-transformed AUC72 and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.51|91.60|0.005
71738947|NCT01278797|142990690|SUPERIORITY_OR_OTHER||Test/Reference ratio of geometric means|94.1||||0.0093||90.0|90.7|97.63|||ANOVA|ANOVA was applied to log-transformed CMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.||97.63|90.70|0.0093
71738948|NCT01278797|142990691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.153|||||||ANOVA|ANOVA was applied to TMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg||||0.153
71738949|NCT01736618|142990694|OTHER||Kaplan-Meier|92.9|||||ONE_SIDED|95.0|91.4|||||||"Ho: The Type I Complication Free Rate at 60 months (p1) does not exceed the performance goal of 85.0%.~Ho: p1 ≤ 85.0% Ha: The Type I Complication Free Rate at 60 months (p1) does exceed the performance goal of 85.0%.~Ha: p1 \> 85.0% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 85.0%."|||91.4|
71738950|NCT01736618|142990695|OTHER||Clopper-Pearson exact confidence bound|98.6|||||ONE_SIDED|95.0|97.4|||||||"Ho: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does not exceed the performance goal of 94.0%.~Ho: p1 ≤ 94.0% Ha: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months (p1) does exceed the performance goal of 94.0%.~Ha: p1 \>94.0% The null hypothesis will be rejected if the lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 94.0%."|||97.4|
71738951|NCT01736618|142990696|OTHER||Kaplan-Meier|99.2|||||ONE_SIDED|95.0|98.8|||||||"Ho: The Electrode-Related Complication Free Rate at 60 months (p1) does not exceed the performance goal of 92.5%.~Ho: p1 ≤ 92.5% Ha: The Electrode-Related Complication Free Rate at 60 months (p1) does exceed the performance goal of 92.5%.~Ha: p1 \> 92.5% The null hypothesis will be rejected if the lower one-sided 95% confidence bound of the proportional means model estimate, using the Peto method for standard error, exceeds the performance goal of 92.5%."|||98.8|
71738952|NCT01736618|142990697|OTHER||Clopper-Pearson exact confidence bound|94.4|||||ONE_SIDED|95.0|93.5|||||||"Ho: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does not exceed the performance goal of 84.0%.~Ho: p1 ≤ 84.0% Ha: The 1st Shock Effectiveness in Converting Induced (Acute) \& Spontaneous Discrete VT/VF Episodes to 60 months (p1) does exceed the performance goal of 84.0%.~Ha: p1 \>84.0% The null hypothesis will be rejected if lower one-sided 95% exact confidence bound of the estimate exceeds the performance goal of 84.0%."|||93.5|
71738953|NCT03637517|142990706|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.926||||0.4847|TWO_SIDED|90.0|0.771|1.113|||ANOVA|||||1.113|0.771|0.4847
71825768|NCT01729819|143155961|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.443||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 1|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 1||||0.443
71763629|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-29.5|1.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.7|-29.5|
71763630|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-15.4|16.5||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.5|-15.4|
71763631|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-27.3|3.7||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||3.7|-27.3|
71763632|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-43.1|-2.4||||||Change at Week 1, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.4|-43.1|
71763633|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-33.2|-0.3||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.3|-33.2|
71763634|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-43.7|-10.8||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-10.8|-43.7|
71763635|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-23.4|9.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-23.4|
71763636|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.4|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-35.6|-3.2||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-35.6|
71763637|NCT00669409|143028840|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-24.4|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-45.8|-2.9||||||Change at Week 1, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-2.9|-45.8|
71763638|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-18.5|12.6||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.6|-18.5|
71763639|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-30.3|0.8||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||0.8|-30.3|
71763640|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-3.2|28.1||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.1|-3.2|
71763641|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.4||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-23.1|
71763642|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-23.3|17.2||||||Change at Week 2, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.2|-23.3|
71763643|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-14.9|16.3||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||16.3|-14.9|
71763644|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-25.5|5.7||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.7|-25.5|
71763645|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-3.4|28.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.5|-3.4|
71763646|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-21.9|9.0||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.0|-21.9|
71763647|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-25.2|15.5||||||Change at Week 2, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||15.5|-25.2|
71763648|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-21.4|11.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.5|-21.4|
71763649|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-30.3|2.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.7|-30.3|
71705250|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705251|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705252|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 26. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705253|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 5 (primary). Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705254|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 12. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705255|NCT03336866|142928451|OTHER|The effect of IXT-m200 on METH exposure was evaluated with a linear mixed effects model. The response variable in the model was the natural-log transformed change in METH exposure parameters: Cmax. The model contained fixed effects for treatment, day (categorical day postdose), natural-log transformed Day 1 baseline parameter and a treatment-by-day interaction, and a random effect for subject.|||||<|0.0001||||||Geometric LS Means Ratios of change in METH exposure for IXT-m200 compared to Placebo on Day 19. Threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Values were compared by a statistical analysis of change from Day 1 in METH PK parameters following IXT-m200 dosing. Geometric LS Mean change from Day 1 for each treatment on each day were calculated. Geometric LS Means Ratios of change in METH exposure for each dose level of IXT-m200 compared to Placebo on each Day 5 (primary), Day 12, Day 19 and Day 26 were calculated along with the 95% confidence intervals.||||<0.0001
71705256|NCT00541775|142928462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<=|0.001||95.0|-0.7|-0.32|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-0.32|-0.70|<=0.001
71705257|NCT00541775|142928463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|5.0|<=|0.001||95.0|-27.6|-8.1|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-8.1|-27.6|<=0.001
71705258|NCT00541775|142928464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.5|STANDARD_ERROR_OF_MEAN|7.9|<=|0.001||95.0|-46.0|-15.0|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.||||-15.0|-46.0|<=0.001
71763650|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-0.6|32.7||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||32.7|-0.6|
71763651|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-22.9|9.5||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.5|-22.9|
71763652|NCT00669409|143028841|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-25.5|17.4||||||Change at Week 2, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||17.4|-25.5|
71705259|NCT00032487|142928465|NON_INFERIORITY_OR_EQUIVALENCE|The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.|Cox Proportional Hazard|0.79|||<|0.05|TWO_SIDED|95.0|0.79|0.99|||Log Rank|||It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.||.99|.79|<0.05
71705260|NCT02547935|142928526|SUPERIORITY||Difference in adjusted mean change|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.37||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||-0.37|-0.80|<0.001
71705261|NCT02547935|142928527|SUPERIORITY||Difference in adjusted mean change|-38.0|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-48.2|-25.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-25.8|-48.2|<0.001
71705262|NCT02547935|142928527|SUPERIORITY||Difference in adjusted mean change|-21.0|STANDARD_ERROR_OF_MEAN|7.3||0.011|TWO_SIDED|95.0|-34.1|-5.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.||-5.2|-34.1|0.011
71705263|NCT02547935|142928528|SUPERIORITY||Difference in adjusted mean change|-0.04|STANDARD_ERROR_OF_MEAN|0.66||0.953|TWO_SIDED|95.0|-1.32|1.26||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||1.26|-1.32|0.953
71705264|NCT02547935|142928528|SUPERIORITY||Difference in adjusted mean change|-0.87|STANDARD_ERROR_OF_MEAN|0.66||0.193|TWO_SIDED|95.0|-2.17|0.44||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.||0.44|-2.17|0.193
71705265|NCT02547935|142928529|SUPERIORITY||Difference in adjusted mean change|-6.1|STANDARD_ERROR_OF_MEAN|5.8||0.298|TWO_SIDED|95.0|-17.5|5.4||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||5.4|-17.5|0.298
71705266|NCT02547935|142928529|SUPERIORITY||Difference in adjusted mean change|-1.9|STANDARD_ERROR_OF_MEAN|5.9||0.746|TWO_SIDED|95.0|-13.6|9.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||9.8|-13.6|0.746
71705267|NCT02547935|142928530|SUPERIORITY||Odds Ratio (OR)|2.98|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||4.8|1.8|<0.001
71705268|NCT02547935|142928530|SUPERIORITY||Odds Ratio (OR)|1.86||||0.013|TWO_SIDED|95.0|1.1|3.0||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.||3.0|1.1|0.013
71705269|NCT02547935|142928531|SUPERIORITY||Odds Ratio (OR)|5.43|||<|0.001|TWO_SIDED|95.0|2.6|11.2||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||11.2|2.6|<0.001
71763653|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-22.9|8.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||8.2|-22.9|
71763654|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-34.4|-3.3||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.3|-34.4|
71763655|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-25.2|6.1||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.1|-25.2|
71763656|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-15.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-30.8|-0.2||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-0.2|-30.8|
71825769|NCT01729819|143155961|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.086||||||Adjusted treatment difference in mean number of nocturnal voids (Combination-tolterodine) at Month 2|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 2||||0.086
71825770|NCT01729819|143155961|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.055||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 3|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 3||||0.055
71825771|NCT01729819|143155961|SUPERIORITY|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.106||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids for the duration of 3 months|ANCOVA|||Treatment difference (Combination-tolterodine) for the duration of 3 months||||0.106
71825772|NCT01729819|143155962|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.178|TWO_SIDED|95.0|-0.2|1.05|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented.Statistical analysis for from very tired to wide awake, how do you feel now"||1.05|-0.20|0.178
71825773|NCT01729819|143155962|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.257|TWO_SIDED|95.0|-0.26|0.94|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate how refreshed you feel now"||0.94|-0.26|0.257
71825774|NCT01729819|143155962|SUPERIORITY|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Mean Difference (Final Values)|0.28||||0.36|TWO_SIDED|95.0|-0.32|0.88|||ANCOVA|Longitudinal analysis of covariance on change from baseline with baseline as a covariate, and treatment and visit as factors.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate the quality of your sleep last night"||0.88|-0.32|0.360
71763657|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.9|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-48.1|-7.6||||||Change at Week 4, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.6|-48.1|
71763658|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-21.3|9.9||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||9.9|-21.3|
71763659|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-32.6|-1.4||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.4|-32.6|
71763660|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-24.3|7.5||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-24.3|
71763661|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-16.8|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-32.2|-1.3||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.3|-32.2|
71763662|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-27.5|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-47.8|-7.1||||||Change at Week 4, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-7.1|-47.8|
71763663|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-25.5|7.4||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.4|-25.5|
71763664|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.1|-3.2||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.2|-36.1|
71763665|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-22.1|11.3||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||11.3|-22.1|
71763666|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-14.7|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-30.9|1.6||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.6|-30.9|
71763667|NCT00669409|143028842|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-44.4|-1.5||||||Change at Week 4, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-1.5|-44.4|
71763668|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-12.2|18.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||18.8|-12.2|
71763669|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-27.0|4.1||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||4.1|-27.0|
71763670|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-17.4|13.9||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-17.4|
71705270|NCT02547935|142928531|SUPERIORITY||Odds Ratio (OR)|1.74||||0.167|TWO_SIDED|95.0|0.8|3.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.||3.8|0.8|0.167
71705271|NCT02547935|142928532|SUPERIORITY||Difference in adjusted mean change|-4.8|STANDARD_ERROR_OF_MEAN|1.8||0.009|TWO_SIDED|95.0|-8.3|-1.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||-1.2|-8.3|0.009
71705272|NCT02547935|142928532|SUPERIORITY||Difference in adjusted mean change|-2.8|STANDARD_ERROR_OF_MEAN|1.8||0.122|TWO_SIDED|95.0|-6.4|0.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.||0.8|-6.4|0.122
71705273|NCT02547935|142928533|SUPERIORITY||Difference in adjusted mean change|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.142|TWO_SIDED|95.0|-0.38|0.05||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.||0.05|-0.38|0.142
71705274|NCT05890586|142928561|SUPERIORITY|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||Hazard ratios greater than one favored the active intervention for a faster time to recovery.|||1.07|0.86|
71705275|NCT05890586|142928562|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.03|2.88|||||Low event rate precluded covariate adjustment.|||2.88|0.03|
71705276|NCT05890586|142928565|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.7|||||Hazard ratios less than one favor the active intervention of inhaled fluticasone furoate. The interval is a highest density credible interval.|The posterior was based on a covariate adjusted Cox proportional hazards regression with skeptical prior. The baseline hazard was a degree 5 M-spline function.||1.7|0.6|
71705277|NCT05890586|142928566|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.74|1.98|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||1.98|0.74|
71705278|NCT05890586|142928567|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.53|2.06|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.06|0.53|
71763671|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-24.8|5.8||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.8|-24.8|
71763672|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-39.2|1.3||||||Change at Week 8, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||1.3|-39.2|
71763673|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-10.6|20.6||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.6|-10.6|
71763674|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-24.0|7.1||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.1|-24.0|
71825775|NCT02512042|143156077|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 (hours 0, before the morning drop) at the Day 14 visit should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.36|||||TWO_SIDED|95.0|-0.69|-0.03||||||||-0.03|-0.69|
71825776|NCT02512042|143156077|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/- 1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.43|0.22||||||||0.22|-0.43|
71763675|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-17.1|14.8||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.8|-17.1|
71763676|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-24.6|6.3||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||6.3|-24.6|
71653334|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0005|TWO_SIDED|95.0|1.32|2.73|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.73|1.32|0.0005
71653335|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0009|TWO_SIDED|95.0|1.31|2.86|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|1.31|0.0009
71653336|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0008|TWO_SIDED|95.0|1.32|2.89|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.32|0.0008
71653337|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0002|TWO_SIDED|95.0|1.41|3.01|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|1.41|0.0002
71653338|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0022|TWO_SIDED|95.0|1.23|2.57|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.57|1.23|0.0022
71653339|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.54|1.21|0.0032
71653340|NCT02709486|142824934|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0013|TWO_SIDED|95.0|1.27|2.69|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment||2.69|1.27|0.0013
71653341|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.59|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.30|0.0006
71653342|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.53||||0.016|TWO_SIDED|95.0|1.08|2.16|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.08|0.0160
71653343|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
71653344|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5118|TWO_SIDED|95.0|0.75|1.8|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.80|0.75|0.5118
71653345|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0093|TWO_SIDED|95.0|1.25|4.81|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.81|1.25|0.0093
71653346|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.46||||0.3017|TWO_SIDED|95.0|0.71|3.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.01|0.71|0.3017
71653347|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.4||||0.216|TWO_SIDED|95.0|0.6|9.58|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.58|0.60|0.2160
71653348|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.33||||0.7174|TWO_SIDED|95.0|0.29|6.08|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.08|0.29|0.7174
71653349|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.45|2.87|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.45|<.0001
71763677|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-38.2|2.5||||||Change at Week 8, Physical functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||2.5|-38.2|
71825777|NCT02512042|143156077|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 14 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.71|-0.09||||||||-0.09|-0.71|
71763678|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-18.3|14.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||14.6|-18.3|
71825778|NCT02512042|143156077|EQUIVALENCE|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population|Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.5|0.13||||||||0.13|-0.50|
71705279|NCT05890586|142928568|SUPERIORITY|No hypothesis test or decision rule was evaluated.|Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.74|2.22|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Adjustment variables are randomization assignment, age (as restricted cubic spline), sex, duration of symptoms prior to receipt of study drug, calendar time (as restricted cubic spline), vaccination status, geographic region (Northeast, Midwest, South, West), call center indicator, and baseline symptom severity.||2.22|0.74|
71705280|NCT05890586|142928569|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.51|0.83|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.83|0.51|
71705281|NCT05890586|142928569|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.7|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.21|0.70|
71763679|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-36.5|-3.6||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||-3.6|-36.5|
71825779|NCT02908620|143156082|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.74||0.322|TWO_SIDED|95.0|-3.06|8.69|||ANOVA||Least squares mean (marginal mean)|||8.69|-3.06|0.322
71653350|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0006|TWO_SIDED|95.0|1.29|2.54|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.29|0.0006
71653351|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0024|TWO_SIDED|95.0|1.23|2.65|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.23|0.0024
71653352|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.49|3.16|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.49|<.0001
71653353|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0373|TWO_SIDED|95.0|1.04|3.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.04|0.0373
71653354|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.17||||0.0046|TWO_SIDED|95.0|1.27|3.72|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.27|0.0046
71653355|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0683|TWO_SIDED|95.0|0.92|9.47|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.47|0.92|0.0683
71653356|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0214|TWO_SIDED|95.0|1.22|11.66|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.66|1.22|0.0214
71653357|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.3|2.58|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.30|0.0006
71653358|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0048|TWO_SIDED|95.0|1.16|2.28|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.28|1.16|0.0048
71653359|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0012|TWO_SIDED|95.0|1.27|2.65|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.65|1.27|0.0012
71653360|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.68|3.47|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.47|1.68|<.0001
71653361|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0537|TWO_SIDED|95.0|0.99|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|0.99|0.0537
71825780|NCT02908620|143156083|SUPERIORITY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|5.48||0.134|TWO_SIDED|95.0|-20.38|2.99|||ANOVA||Least squares mean (marginal mean)|||2.99|-20.38|0.134
71653362|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0001|TWO_SIDED|95.0|1.58|4.13|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|1.58|0.0001
71653363|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1155|TWO_SIDED|95.0|0.82|6.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.27|0.82|0.1155
71653364|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0271|TWO_SIDED|95.0|1.13|7.96|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.96|1.13|0.0271
71653365|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.63|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.30|0.0007
71653366|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0011|TWO_SIDED|95.0|1.26|2.56|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.26|0.0011
71653367|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0009|TWO_SIDED|95.0|1.27|2.52|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.27|0.0009
71653368|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.47|2.91|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.91|1.47|<.0001
71653369|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0064|TWO_SIDED|95.0|1.18|2.78|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.18|0.0064
71653370|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.68||||0.018|TWO_SIDED|95.0|1.09|2.58|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.09|0.0180
71653371|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|5.61||||0.0006|TWO_SIDED|95.0|2.09|15.08|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||15.08|2.09|0.0006
71653372|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0034|TWO_SIDED|95.0|1.64|12.13|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.13|1.64|0.0034
71653373|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0022
71653374|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0014|TWO_SIDED|95.0|1.25|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.25|0.0014
71825781|NCT02908620|143156084|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|4.92||0.442|TWO_SIDED|95.0|-6.48|14.62|||ANOVA||Least squares mean (marginal mean)|||14.62|-6.48|0.442
71653375|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0003|TWO_SIDED|95.0|1.33|2.64|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.33|0.0003
71653376|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.68||||0.003|TWO_SIDED|95.0|1.19|2.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.36|1.19|0.0030
71653377|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0754|TWO_SIDED|95.0|0.96|2.24|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.24|0.96|0.0754
71825782|NCT02908620|143156085|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|4.78||0.172|TWO_SIDED|95.0|-3.27|16.9|||ANOVA||Least squares mean (marginal mean)|||16.90|-3.27|0.172
71825783|NCT05824351|143156099|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|-0.2571|STANDARD_DEVIATION|0.7|<|0.0001|TWO_SIDED||||||t-test, 1 sided|One-sided lower t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||<0.0001
71825784|NCT05824351|143156099|EQUIVALENCE|Equivalence is defined as an average difference of \< or = 2|Mean of paired differences|0.0294|STANDARD_DEVIATION|0.79||0.0003|TWO_SIDED||||||t-test, 1 sided|One-sided upper t-test||Draize scores for erythema/eschar and edema were summed for analysis (range of 0 to 8, where a higher score indicated greater irritation).||||0.0003
71653378|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0253|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.06|0.0253
71653379|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0098|TWO_SIDED|95.0|1.3|6.83|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.83|1.30|0.0098
71653380|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.72||||0.223|TWO_SIDED|95.0|0.72|4.13|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.13|0.72|0.2230
71653381|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0201|TWO_SIDED|95.0|1.07|2.12|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.12|1.07|0.0201
71653382|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0021|TWO_SIDED|95.0|1.22|2.44|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.44|1.22|0.0021
71653383|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
71653384|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0004|TWO_SIDED|95.0|1.32|2.64|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.64|1.32|0.0004
71653385|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.32||||0.2031|TWO_SIDED|95.0|0.86|2.01|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.01|0.86|0.2031
71653386|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0867|TWO_SIDED|95.0|0.95|2.18|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|0.95|0.0867
71653387|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1746|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.22|0.77|0.1746
71653388|NCT02709486|142824936|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1039|TWO_SIDED|95.0|0.87|4.57|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.57|0.87|0.1039
71705282|NCT05890586|142928569|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.55|1.03|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.03|0.55|
71705283|NCT05890586|142928569|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.68|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.39|0.68|
71653389|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0003|TWO_SIDED|95.0|1.33|2.68|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|1.33|0.0003
71653390|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0286|TWO_SIDED|95.0|1.04|2.1|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|1.04|0.0286
71653391|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.45||||0.1031|TWO_SIDED|95.0|0.93|2.27|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.27|0.93|0.1031
71653392|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2033|TWO_SIDED|95.0|0.85|2.1|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.10|0.85|0.2033
71705284|NCT05890586|142928570|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.04|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.04|
71705285|NCT05890586|142928570|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.98|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.51|0.98|
71705286|NCT05890586|142928570|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.35|0.84|
71705287|NCT05890586|142928570|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.92|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.47|0.92|
71705288|NCT05890586|142928571|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.8|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.29|0.80|
71705289|NCT05890586|142928571|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.84|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.47|0.84|
71705290|NCT05890586|142928571|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.8|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.46|0.80|
71705291|NCT05890586|142928571|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.44|0.77|
71705292|NCT05890586|142928572|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.16|0.70|
71705293|NCT05890586|142928572|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.10|0.63|
71705294|NCT05890586|142928572|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||0.99|0.54|
71705295|NCT05890586|142928572|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.66|
71763680|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-19.5|13.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||13.9|-19.5|
71825785|NCT02929069|143156147|SUPERIORITY||Risk Ratio (RR)|0.88||||0.52|TWO_SIDED|95.0|0.52|1.25|||Regression, Logistic|||||1.25|.52|0.52
71763681|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-27.1|5.4||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.4|-27.1|
71763682|NCT00669409|143028843|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-32.0|10.9||||||Change at Week 8, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.9|-32.0|
71825786|NCT00813488|143156207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|0.06|0.2|||Mixed effects ANOVA crossover model|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.20|0.06|0.0004
71653393|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0064|TWO_SIDED|95.0|1.34|5.86|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.86|1.34|0.0064
71763683|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|13.0|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-2.5|28.6||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.6|-2.5|
71763684|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-21.0|10.0||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.0|-21.0|
71763685|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.92|||TWO_SIDED|95.0|-10.4|20.9||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.9|-10.4|
71763686|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|7.73|||TWO_SIDED|95.0|-23.1|7.5||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.5|-23.1|
71763687|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|10.25|||TWO_SIDED|95.0|-29.7|10.8||||||Change at Week 13, Pain: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.8|-29.7|
71763688|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|14.3|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-1.3|29.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||29.8|-1.3|
71763689|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|7.89|||TWO_SIDED|95.0|-19.2|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-19.2|
71763690|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|95.0|-9.1|22.8||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||22.8|-9.1|
71825787|NCT00813488|143156208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2242|TWO_SIDED|95.0|-0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.05|-0.01|0.2242
71653394|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.44||||0.3706|TWO_SIDED|95.0|0.65|3.23|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.65|0.3706
71653395|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.39||||0.2121|TWO_SIDED|95.0|0.61|9.41|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.41|0.61|0.2121
71653396|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4859|TWO_SIDED|95.0|0.39|7.11|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.11|0.39|0.4859
71653397|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.6|3.17|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.17|1.60|<.0001
71653398|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.96|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.50|<.0001
71763691|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|7.83|||TWO_SIDED|95.0|-25.8|5.1||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||5.1|-25.8|
71763692|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|10.3|||TWO_SIDED|95.0|-28.8|12.0||||||Change at Week 13, Physical Functions: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||12.0|-28.8|
71763693|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-9.5|23.4||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||23.4|-9.5|
71653399|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.91||||0.002|TWO_SIDED|95.0|1.27|2.87|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.27|0.0020
71653400|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.53|3.4|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.53|<.0001
71653401|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.23||||0.0107|TWO_SIDED|95.0|1.21|4.14|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.14|1.21|0.0107
71653402|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0126|TWO_SIDED|95.0|1.18|4.02|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.02|1.18|0.0126
71653403|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.67||||0.1516|TWO_SIDED|95.0|0.7|10.26|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||10.26|0.70|0.1516
71653404|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|4.49||||0.021|TWO_SIDED|95.0|1.25|16.05|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||16.05|1.25|0.0210
71653405|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0034|TWO_SIDED|95.0|1.18|2.31|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.18|0.0034
71653406|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.75||||0.001|TWO_SIDED|95.0|1.26|2.45|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.26|0.0010
71653407|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0014|TWO_SIDED|95.0|1.27|2.71|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.71|1.27|0.0014
71653408|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.46|3.1|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.46|<.0001
71653409|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0007|TWO_SIDED|95.0|1.49|4.55|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.55|1.49|0.0007
71653410|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0018|TWO_SIDED|95.0|1.39|4.24|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.24|1.39|0.0018
71653411|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|4.1||||0.015|TWO_SIDED|95.0|1.31|12.79|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||12.79|1.31|0.0150
71653412|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0211|TWO_SIDED|95.0|1.22|11.78|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||11.78|1.22|0.0211
71653413|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.43|2.84|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.84|1.43|<.0001
71653414|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.55|3.1|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.55|<.0001
71825788|NCT00813488|143156209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.0106|TWO_SIDED|95.0|0.01|0.11||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.11|0.01|0.0106
71825789|NCT00813488|143156210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.21|0.4||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.40|.21|<0.0001
71825790|NCT00813488|143156211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|0.18|0.37||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||.37|0.18|<0.0001
71825791|NCT00813488|143156212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|0.08|0.27||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.27|0.08|0.0002
71825792|NCT00813488|143156219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.5|||ANOVA|||||0.50|0.25|<0.0001
71825793|NCT00813488|143156220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||<|0.0001|TWO_SIDED|95.0|0.55|1.1|||ANOVA|||||1.10|.55|<0.0001
71825794|NCT00813488|143156221|SUPERIORITY_OR_OTHER|||||||0.5575|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.5575
71825795|NCT00813488|143156222|SUPERIORITY_OR_OTHER|||||||0.0981|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0981
71825796|NCT00813488|143156223|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0443
71705296|NCT05890586|142928573|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.85|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.37|0.85|
71825797|NCT00813488|143156224|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
71825798|NCT00813488|143156225|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
71825799|NCT00813488|143156226|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0018
71825800|NCT00813488|143156227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|0.58|0.9||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.90|0.58|<0.0001
71825801|NCT00813488|143156229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1464||||0.7012|TWO_SIDED|95.0|0.6|2.3|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.3|0.6|0.7012
71825802|NCT00813488|143156230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0704||||0.6545|TWO_SIDED|95.0|0.8|1.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.8|0.6545
71825803|NCT00813488|143156231|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2544||||0.0407|TWO_SIDED|95.0|1.0|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.0|0.0407
71705297|NCT05890586|142928573|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.85|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.44|0.85|
71763694|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|8.34|||TWO_SIDED|95.0|-22.4|10.6||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||10.6|-22.4|
71763695|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|12.2|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-4.5|28.9||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||28.9|-4.5|
71763696|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|8.22|||TWO_SIDED|95.0|-25.2|7.2||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||7.2|-25.2|
71763697|NCT00669409|143028844|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|10.86|||TWO_SIDED|95.0|-22.4|20.5||||||Change at Week 13, Stiffness: Mixed Model for Repeated Measures analyses included fixed effects of treatment, week, treatment by week, part, and baseline values.||20.5|-22.4|
71763698|NCT03583385|143028856|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|103.42|||||TWO_SIDED|90.0|95.18|112.37||||||||112.37|95.18|
71763699|NCT03583385|143028857|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|106.78|||||TWO_SIDED|90.0|98.99|115.19||||||||115.19|98.99|
71763700|NCT02191865|143028887|SUPERIORITY_OR_OTHER||ratio of the geometric means|215.39|STANDARD_DEVIATION|73.5|||TWO_SIDED|90.0|120.71|384.32|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||384.32|120.71|
71763701|NCT02191865|143028887|SUPERIORITY_OR_OTHER||Ratio of geometric means|867.13|STANDARD_DEVIATION|45.9|||TWO_SIDED|90.0|572.93|1312.41|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1312.41|572.93|
71763702|NCT02191865|143028888|SUPERIORITY_OR_OTHER||ratio of the geometric means|221.76|STANDARD_DEVIATION|61.4|||TWO_SIDED|90.0|134.73|365.01|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||365.01|134.73|
71763703|NCT02191865|143028888|SUPERIORITY_OR_OTHER||Ratio of geometric means|761.01|STANDARD_DEVIATION|69.1|||TWO_SIDED|90.0|439.01|1319.18|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1319.18|439.01|
71763704|NCT02191865|143028889|SUPERIORITY_OR_OTHER||ratio of the geometric means|216.79|STANDARD_DEVIATION|75.0|||TWO_SIDED|90.0|120.37|390.45|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||390.45|120.37|
71763705|NCT02191865|143028889|SUPERIORITY_OR_OTHER||Ratio of geometric means|870.74|STANDARD_DEVIATION|45.7|||TWO_SIDED|90.0|576.36|1315.49|||ANOVA|Fixed effect: 'hepatic status'; indicated whether a subject with hepatic impairment or a healthy subject , Random effect: 'matched pair'.|Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.||1315.49|576.36|
71763706|NCT04693234|143028891|SUPERIORITY|||||||0.0054|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0054
71763707|NCT04693234|143028892|SUPERIORITY|||||||0.0127|||||||Binomial Exact Test|The p-value was calculated from the binomial exact test of tislelizumab combined with ociperlimab versus historical rate of 0.15.||||||0.0127
71763708|NCT04643158|143028912|SUPERIORITY||Least Square Mean Difference|0.0236||||0.828|TWO_SIDED|95.0|-0.1934|0.2406|||Mixed Models Analysis|||||0.2406|-0.1934|0.828
71763709|NCT04643158|143028912|SUPERIORITY||Least Square Mean Difference|0.196||||0.035|TWO_SIDED|95.0|0.0143|0.3778|||Mixed Models Analysis|||||0.3778|0.0143|0.035
71763710|NCT04643158|143028932|SUPERIORITY||Geometric Least Square Mean Ratio|-38.31||||0.202|TWO_SIDED|95.0|-71.11|31.72|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||31.72|-71.11|0.202
71763711|NCT04643158|143028932|SUPERIORITY||Geometric Least Square Mean Ratio|-15.43||||0.596|TWO_SIDED|95.0|-55.57|60.96|||Mixed Models Analysis||Analyses were done on the natural log scale and the results were back-transformed to linear scale.|||60.96|-55.57|0.596
71763712|NCT00332722|143029030|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
71763713|NCT00332722|143029031|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired t test|||||||<0.05
71763714|NCT00918736|143029036|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be \> 1 using pair t-test after 3 weekly injections, investigators need \> 42 patients to give \> 90% power to reject the null hypothesis-mean AOS score reduction \<1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients||||<0.05
71653415|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.47|3.0|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.00|1.47|<.0001
71653416|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.08|||<|0.0001|TWO_SIDED|95.0|1.46|2.96|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.46|<.0001
71653417|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.74||||0.018|TWO_SIDED|95.0|1.1|2.76|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.10|0.0180
71653418|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0072|TWO_SIDED|95.0|1.18|2.94|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.18|0.0072
71653419|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|10.84||||0.0015|TWO_SIDED|95.0|2.49|47.22|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||47.22|2.49|0.0015
71653420|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|8.62||||0.0044|TWO_SIDED|95.0|1.96|37.96|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||37.96|1.96|0.0044
71653421|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0018|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0018
71653422|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0011|TWO_SIDED|95.0|1.26|2.5|||Regression, Logistic|||Week 16, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|1.26|0.0011
71653423|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0035|TWO_SIDED|95.0|1.19|2.38|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.38|1.19|0.0035
71653424|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0022|TWO_SIDED|95.0|1.22|2.43|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.43|1.22|0.0022
71653425|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0155|TWO_SIDED|95.0|1.11|2.72|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.11|0.0155
71653426|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1549|TWO_SIDED|95.0|0.88|2.2|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.20|0.88|0.1549
71653427|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0212|TWO_SIDED|95.0|1.18|7.37|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||7.37|1.18|0.0212
71653428|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0373|TWO_SIDED|95.0|1.06|6.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.57|1.06|0.0373
71653429|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0006|TWO_SIDED|95.0|1.29|2.57|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.29|0.0006
71763715|NCT01474018|143029043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
71763716|NCT01474018|143029044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71763717|NCT01474018|143029044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
71763718|NCT03462511|143029058|SUPERIORITY||Mean Difference (Net)|2.4||||0.067|TWO_SIDED|||||Independent variables: study month, study group, their interactions and a person-level random intercept to incorporate clustering.|Regression, Linear|||Based on estimated effect size from our prior feasibility trial, the target enrollment was 87 dyads plus additional 20% to account for attrition before Month 6 or blood transfusions or acute illness rendering HbF levels inaccurate.||||0.067
71763719|NCT03462511|143029059|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||We compared the difference in proportion of days covered by hydroxyurea at two timepoints: (1) from the year prior to study entry to 6 months (the end of the active intervention phase of the trial) and (2) from 6 months to 12 months (the sustainability phase of the trial).||||0.60
71763720|NCT03462511|143029060|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||We hypothesized that, compared to the control group, generic quality of life (QOL) for youth in the intervention group would improve from baseline to 9 months.||||<0.001
71825804|NCT00813488|143156232|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5745||||0.0007|TWO_SIDED|95.0|1.2|2.0|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.2|0.0007
71653430|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.51|3.02|||Regression, Logistic|||Week 24, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.51|<.0001
71653431|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0152|TWO_SIDED|95.0|1.09|2.18|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.18|1.09|0.0152
71653432|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0018|TWO_SIDED|95.0|1.23|2.45|||Regression, Logistic|||Week 24, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.23|0.0018
71653433|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.47||||0.097|TWO_SIDED|95.0|0.93|2.31|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|0.93|0.0970
71653434|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3435|TWO_SIDED|95.0|0.79|1.98|||Regression, Logistic|||Week 24, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.98|0.79|0.3435
71653435|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0236|TWO_SIDED|95.0|1.17|9.27|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||9.27|1.17|0.0236
71653436|NCT02709486|142824937|SUPERIORITY||Odds Ratio (OR)|3.14||||0.0296|TWO_SIDED|95.0|1.12|8.81|||Regression, Logistic|||Week 24, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||8.81|1.12|0.0296
71653437|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|2.14||||0.0132|TWO_SIDED|95.0|1.17|3.9|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.90|1.17|0.0132
71653438|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1274|TWO_SIDED|95.0|0.87|3.02|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|0.87|0.1274
71763721|NCT03462511|143029060|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test generic quality of life (QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.04|||||||Regression, Linear|||We hypothesized that the improvement in quality of life experienced by the intervention group would be sustained from month 9 to month 12.||||0.04
71763722|NCT03462511|143029061|SUPERIORITY|||||||0.47|||||||Regression, Linear|||We hypothesized that, compared to the control group, sickle cell disease specific quality of life (SC-QOL) for youth in the intervention group would improve from baseline to 9 months.||||0.47
71763723|NCT03462511|143029061|NON_INFERIORITY|30% of the standard deviation was used as the non-inferiority margin. For this test sickle cell disease specific quality of life (SC-QOL) scores for months 4-9 (efficacy period) were compared to months \>9 (sustainability period).||||||0.045|||||||Regression, Linear|||We hypothesized that the improvement in sickle cell disease specific quality of life (SC-QOL) experienced by the intervention group would be sustained from month 9 to month 12.||||0.045
71825805|NCT00813488|143156233|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5828||||0.0372|TWO_SIDED|95.0|1.0|2.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.4|1.0|0.0372
71653439|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0016|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.76|1.44|0.0016
71653440|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.0001|TWO_SIDED|95.0|1.84|6.03|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||6.03|1.84|<.0001
71653441|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0089|TWO_SIDED|95.0|1.2|3.49|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.20|0.0089
71653442|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0012|TWO_SIDED|95.0|1.42|4.1|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.10|1.42|0.0012
71653443|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0006|TWO_SIDED|95.0|1.45|3.98|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.98|1.45|0.0006
71653444|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|1.92|5.21|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||5.21|1.92|<.0001
71653445|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0203|TWO_SIDED|95.0|1.1|3.06|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.10|0.0203
71653446|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.77|4.86|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.86|1.77|<.0001
71653447|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0775|TWO_SIDED|95.0|0.95|2.55|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.55|0.95|0.0775
71653448|NCT02709486|142824939|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0064|TWO_SIDED|95.0|1.21|3.21|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.21|1.21|0.0064
71653449|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.70|<.0001
71653450|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.11||0.0009|TWO_SIDED|95.0|-0.58|-0.15|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.15|-0.58|0.0009
71653451|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.48|-1.00|<.0001
71763724|NCT03462511|143029062|SUPERIORITY|||||||0.002|||||||Regression, Linear|||We hypothesized that, compared to the control group, responsibility for self-management concordance for youth-caregiver dyads in the intervention group would improve from baseline to 6 months.||||0.002
71653452|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.77|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.77|0.0001
71653453|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.06|-0.5|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.06|<.0001
71825806|NCT00813488|143156234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3722||||0.3099|TWO_SIDED|95.0|0.7|2.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.5|0.7|0.3099
71705298|NCT05890586|142928573|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.7|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.70|
71705299|NCT05890586|142928573|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.78|1.37|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.37|0.78|
71705300|NCT05890586|142928574|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.68|1.05|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.05|0.68|
71705301|NCT05890586|142928574|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.7|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.11|0.70|
71705302|NCT05890586|142928574|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.21|0.72|
71763725|NCT03462511|143029062|NON_INFERIORITY|50% of the standard deviation was used as the non-inferiority margin. For this test youth caregiver concordance for self-management responsibility scores for months 0-6 (efficacy period) were compared to months 6-12 (sustainability period).||||||0.23|||||||Regression, Linear|||We hypothesized that the improvement in concordance between youth and caregivers for self-management responsibility experienced by the intervention group would be sustained from month 6 to month 12.||||0.23
71763726|NCT03495856|143029086|OTHER|within-group paired t-test|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.37||0.05|TWO_SIDED|95.0|-1.55|0.0||The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.|t-test, 2 sided|||||0.00|-1.55|0.05
71763727|NCT03495856|143029087|OTHER|within-group paired t-test|Mean Difference (Final Values)|-3.67|STANDARD_ERROR_OF_MEAN|1.42||0.017|TWO_SIDED|95.0|-6.63|-0.71|||t-test, 2 sided|||||-0.71|-6.63|0.017
71763728|NCT03495856|143029088|OTHER|Within-group paired t-test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.7||0.938|TWO_SIDED|95.0|-1.39|1.5|||t-test, 2 sided|||||1.50|-1.39|0.938
71763729|NCT03495856|143029089|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.05||0.005|TWO_SIDED|95.0|-5.53|-1.15||The a priori threshold for statistical significance was p less than or equal to 0.05.|t-test, 2 sided|||||-1.15|-5.53|0.005
71763730|NCT03495856|143029090|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|1.38||0.124|TWO_SIDED|95.0|-5.09|0.66|||t-test, 2 sided|||||0.66|-5.09|0.124
71763731|NCT03495856|143029091|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|-7.3|-2.07|||t-test, 2 sided|||||-2.07|-7.30|0.001
71763732|NCT03495856|143029092|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.5||0.018|TWO_SIDED|95.0|-2.31|-0.24|||t-test, 2 sided|||||-0.24|-2.31|0.018
71763733|NCT03495856|143029093|OTHER|Within-group paired t-test|Mean Difference (Final Values)|2.79|STANDARD_ERROR_OF_MEAN|1.07||0.016|TWO_SIDED|95.0|0.58|5.01|||t-test, 2 sided|||||5.01|0.58|0.016
71763734|NCT03495856|143029094|OTHER|Within-group paired t-test|Mean Difference (Final Values)|-4.96|STANDARD_ERROR_OF_MEAN|1.41||0.002|TWO_SIDED|95.0|-7.88|-2.03|||t-test, 2 sided|||||-2.03|-7.88|0.002
71705303|NCT05890586|142928574|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
71763735|NCT03495856|143029095|OTHER|Within-group paired t-test|Mean Difference (Final Values)|13.27|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|8.47|18.07|||t-test, 2 sided|||||18.07|8.47|<0.001
71763736|NCT03495856|143029096|OTHER|Within-group paired t-test|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|1.96||0.001|TWO_SIDED|95.0|3.92|12.08|||t-test, 2 sided|||||12.08|3.92|0.001
71763737|NCT00435045|143029097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used.||||||0.0002||95.0|||||ANOVA|||||||0.0002
71763738|NCT01015638|143029137|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
71763739|NCT01015638|143029138|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||>0.05
71763740|NCT01015638|143029139|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
71763741|NCT01015638|143029140|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Tukey-Kramer Multiple Comparisons Test|||||||> 0.05
71763742|NCT03679754|143029175|OTHER||||||||||||||||||Subjects in the Expansion trial did not have biopsies analyzed for cellular responses.|||
71763743|NCT05487196|143029185|NON_INFERIORITY|The noninferiority margin δ was set as the median of fentanyl group + 30 representing a 1-point pain numeric rating scale difference per unit time across the 30-minute initiation period. A conventional 1-sided 95% confidence interval (CI) was constructed using normal distribution assumptions. Analysis was by intent to treat. Comparisons of PI-AUC30 between the three agents were made by one-way ANOVA.||||||0.226|||||||ANOVA|||||||0.226
71763744|NCT05487196|143029186|SUPERIORITY|||||||0.16|||||||ANOVA|||||||0.16
71763745|NCT05487196|143029187|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
71763746|NCT05487196|143029188|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
71763747|NCT05487196|143029189|SUPERIORITY|||||||0.22|||||||ANOVA|||||||0.22
71763748|NCT05487196|143029190|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
71763749|NCT05487196|143029191|SUPERIORITY|||||||0.83|||||||Fisher Exact|||||||0.83
71763750|NCT05487196|143029192|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
71763751|NCT05487196|143029193|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
71763752|NCT05487196|143029194|SUPERIORITY|||||||0.36|||||||Fisher Exact|||||||0.36
71763753|NCT05487196|143029195|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
71763754|NCT05487196|143029196|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
71763755|NCT05487196|143029197|SUPERIORITY|||||||0.98|||||||Kruskal-Wallis|||||||0.98
71763756|NCT00711477|143029201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.5|0.9||||||||0.90|0.50|
71763757|NCT00711477|143029202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.38|TWO_SIDED|95.0|-1.83|0.72|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.72|-1.83|0.380
71763758|NCT00711477|143029203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.744|TWO_SIDED|95.0|-2.87|2.07|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||2.07|-2.87|0.744
71763759|NCT00711477|143029204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.139|TWO_SIDED|95.0|-3.84|0.56|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.56|-3.84|0.139
71763760|NCT00711477|143029205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.094|TWO_SIDED|95.0|-2.96|0.24|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.24|-2.96|0.094
71763761|NCT00711477|143029206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.102|TWO_SIDED|95.0|-5.48|0.51|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||0.51|-5.48|0.102
71763762|NCT00711477|143029207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4||||0.16||95.0|-22.7|3.89|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline||||3.89|-22.7|0.160
71763763|NCT00711477|143029208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|90.0|0.4|0.8||||||||0.80|0.40|
71763764|NCT00711477|143029209|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|0.5|1.0||||||||1.00|0.50|
71763765|NCT00711477|143029210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||||TWO_SIDED|90.0|0.74|1.24||||||||1.24|0.74|
71763766|NCT00711477|143029211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|90.0|0.95|1.65||||||||1.65|0.95|
71763767|NCT00711477|143029212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|90.0|0.31|0.57||||||||0.57|0.31|
71763768|NCT02055118|143029242|SUPERIORITY||Least squares mean|3.0|STANDARD_ERROR_OF_MEAN|5.12||0.5669|TWO_SIDED|95.0|-7.3|13.3|||Mixed model repeated measures|||The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to \[\<=\] 70 or \>70), baseline age group (\<6 years or \>=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.||13.3|-7.3|0.5669
71763769|NCT01001325|143029297|SUPERIORITY_OR_OTHER|||||||0.685||95.0|||||Fisher Exact|||"Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.~Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%"||||0.685
71763770|NCT01584440|143029298|SUPERIORITY||Ordinary Least Squares (OLS) Z-statistic|-1.5|||<=|0.001|TWO_SIDED||||||ANCOVA|Sequential Parallel Comparison Design (SPCD): data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
71763771|NCT01584440|143029298|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.5|||||TWO_SIDED||||||||Day 36|||||
71763772|NCT01584440|143029298|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.59|||||TWO_SIDED||||||||Day 70|||||
71763773|NCT01584440|143029300|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
71763774|NCT01584440|143029300|SUPERIORITY||ANCOVA Least Squares Mean Difference|-4.2|||||TWO_SIDED||||||||||Day 36|||
71763775|NCT01584440|143029300|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.78|||||TWO_SIDED||||||||Day 70|||||
71763776|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|0.77||||0.444|TWO_SIDED||||||ANCOVA|Delusions Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.444
71763777|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.27|||||TWO_SIDED||||||||Delusions Domain; Day 36|||||
71763778|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.78|||||TWO_SIDED||||||||Delusions Domain; Day 70|||||
71763779|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-0.18||||0.861|TWO_SIDED||||||ANCOVA|Hallucinations Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.861
71763780|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.29|||||TWO_SIDED||||||||Hallucinations Domain; Day 36|||||
71763781|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.22|||||TWO_SIDED||||||||Hallucinations Domain; Day 70|||||
71763782|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-0.32||||0.749|TWO_SIDED||||||ANCOVA|Depression/Dysphoria Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.749
71763783|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 36|||||
71763784|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.1|||||TWO_SIDED||||||||Depression/Dysphoria Domain; Day 70|||||
71763785|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-0.81||||0.416|TWO_SIDED||||||ANCOVA|Anxiety Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.416
71763786|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Anxiety Domain; Day 36|||||
71763787|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.81|||||TWO_SIDED||||||||Anxiety Domain|||||
71763788|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-1.07||||0.287|TWO_SIDED||||||ANCOVA|Euphoria/Elation Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.287
71653454|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0006|TWO_SIDED|95.0|-0.77|-0.21|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.21|-0.77|0.0006
71653455|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.2|-0.62|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.62|-1.20|<.0001
71653456|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.06|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.47|-1.06|<.0001
71653457|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.59|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.59|-1.20|<.0001
71653458|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.64|-1.25|<.0001
71653459|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.93|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.93|0.0001
71653460|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.5|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.50|-1.13|<.0001
71653461|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.39|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.05|<.0001
71705304|NCT05890586|142928575|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio, log|1.3|||||TWO_SIDED|95.0|1.05|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.60|1.05|
71705305|NCT05890586|142928575|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.52|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.52|1.00|
71705306|NCT05890586|142928575|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.27|0.84|
71705307|NCT05890586|142928575|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.21|0.80|
71705308|NCT05890586|142928576|SUPERIORITY||Difference in model estimate time unwell|-0.07|||||TWO_SIDED|95.0|-0.43|0.31|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.31|-0.43|
71705309|NCT05890586|142928577|SUPERIORITY||Difference in model estimated means|0.08|||||TWO_SIDED|95.0|-0.37|0.52|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.52|-0.37|
71705310|NCT00669331|142928647|SUPERIORITY_OR_OTHER||Rate Ratio Mannitol:Control|0.92||||0.3115|TWO_SIDED|95.0|0.78|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline PE rate as predictors and log of follow-up time as an offset variable|For rate ratio, Mannitol rate is the numerator, Control rate is the denominator|||1.08|0.78|0.3115
71763789|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.04|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 36|||||
71763790|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.34|||||TWO_SIDED||||||||Euphoria/Elation Domain; Day 70|||||
71763791|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-1.31||||0.191|TWO_SIDED||||||ANCOVA|Apathy/Indifference Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.191
71825807|NCT00813488|143156235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8434||||0.5777|TWO_SIDED|95.0|0.5|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.5|.5|0.5777
71705311|NCT00669331|142928648|SUPERIORITY_OR_OTHER||LS mean difference across the 52 weeks|-2.4||||0.0457|TWO_SIDED|95.0|-4.76|-0.05|||Mixed model repeated measures analysis|Model included treatment, visit, treatment\*visit, region and baseline SGRQ Total score.|difference calculated Mannitol-control. Negative difference is in favour of mannitol since lower scores indicate improved quality of life.|||-0.05|-4.76|0.0457
71705312|NCT00669331|142928649|SUPERIORITY_OR_OTHER||Rate ratio|0.91||||0.2754|TWO_SIDED|95.0|0.77|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline pulmonary exacerbation rate as predictors, log follow-up as offset|Rate ratio is for mannitol vs control.|||1.08|0.77|0.2754
71705313|NCT00669331|142928650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0218|TWO_SIDED|95.0|0.63|0.96|||Regression, Cox|Cox regression model was stratified by region and baseline PE rate||||0.96|0.63|0.0218
71705314|NCT00669331|142928651|SUPERIORITY_OR_OTHER||Rate ratio|0.88||||0.3602|TWO_SIDED|95.0|0.67|1.16|||Negative binomial model|treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||Analysed using a negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||1.16|0.67|0.3602
71705315|NCT00669331|142928652|SUPERIORITY_OR_OTHER||ls mean difference across 52 weeks|2.76||||0.0355|TWO_SIDED|95.0|0.19|5.33|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline sputum weight (g).|Difference mannitol-control|||5.33|0.19|0.0355
71705316|NCT00669331|142928653|SUPERIORITY_OR_OTHER||LS mean diff across post-baseline visits|-0.44||||0.1159|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|Model includes treatment, visit, treatment\*visit, region and baseline ESS score|Negative change indicates an improvement in ESS score. Difference calculated Mannitol - Control.|||0.11|-0.99|0.1159
71705317|NCT00669331|142928654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.56||||0.6677|TWO_SIDED|95.0|-27.01|42.13|||Mixed Models Analysis|Model of absolute change from baseline in FEV1. Model includes terms for treatment, visit, trt\*visit, region and baseline value|ls mean difference Mannitol-Control|||42.13|-27.01|0.6677
71763792|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
71763793|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.77|||||TWO_SIDED||||||||Apathy/Indifference Domain; Day 36|||||
71825808|NCT00813488|143156236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.9567|TWO_SIDED|95.0|0.6|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.6|0.9567
71763794|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-1.1||||0.271|TWO_SIDED||||||ANCOVA|Disinhibition Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.271
71763795|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.22|||||TWO_SIDED||||||||Disinhibition Domain; Day 36|||||
71705318|NCT00669331|142928661|SUPERIORITY_OR_OTHER||Rate ratio|0.61||||0.0928|TWO_SIDED|95.0|0.34|1.09|||Negative binomial regression|||||1.09|0.34|0.0928
71705319|NCT03300336|142928685|SUPERIORITY||Odds Ratio (OR)|0.77||||0.01|TWO_SIDED|95.0|0.64|0.93||a priori threshold for statistical significance p \<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline timepoints), and a site-level random effect. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||0.93|0.64|0.01
71705320|NCT03300336|142928686|SUPERIORITY||rate ratio|1.05||||0.25|TWO_SIDED|95.0|0.97|1.15||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a log link and negative binomial distribution.|The rate ratio compares the intervention rate in the numerator vs the usual care rate in the denominator|Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the 7 post-baseline time points), a site-level random effect and random effects for each of the time periods. Model was not adjusted for patient characteristics. Estimated means and standard errors are provided in Outcome Measure Data table.||1.15|0.97|0.25
71763796|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.37|||||TWO_SIDED||||||||Disinhibition Domain; Day 70|||||
71763797|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-2.18||||0.029|TWO_SIDED||||||ANCOVA|Irritability/Lability Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.029
71763798|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.7|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 36|||||
71763799|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.93|||||TWO_SIDED||||||||Irritability/Lability Domain; Day 70|||||
71763800|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-2.21||||0.027|TWO_SIDED||||||ANCOVA|Aberrant Motor Behavior Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.027
71763801|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.38|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 36|||||
71763802|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.22|||||TWO_SIDED||||||||Aberrant Motor Behavior Domain; Day 70|||||
71763803|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-1.09||||0.274|TWO_SIDED||||||ANCOVA|Sleep/Nighttime Behavior Disorders Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.274
71763804|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.57|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 36|||||
71825809|NCT00813488|143156237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1366||||0.4253|TWO_SIDED|95.0|0.8|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|0.8|0.4253
71763805|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.08|||||TWO_SIDED||||||||Sleep/Nighttime Behavior disorders Domain; Day 70|||||
71825810|NCT00813488|143156238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4269||||0.0038|TWO_SIDED|95.0|1.1|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.1|0.0038
71653462|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.44|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.44|-1.10|<.0001
71653463|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.06|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.39|-1.06|<.0001
71653464|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.13|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.46|-1.13|<.0001
71653465|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.87|-0.16|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.87|0.0040
71653466|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.27|-0.98|0.0005
71653467|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.33|-1.06|0.0002
71653468|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.32|-1.05|0.0002
71653469|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.2||0.0506|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.00|-0.78|0.0506
71653470|NCT02709486|142824940|SUPERIORITY||Least Square Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.0086|TWO_SIDED|95.0|-0.91|-0.13|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.91|0.0086
71653471|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.07|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.07|<.0001
71653472|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.94|<.0001
71653473|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.03|-0.41|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.03|<.0001
71763806|NCT01584440|143029301|SUPERIORITY||OLS Z-statistic|-0.65||||0.513|TWO_SIDED||||||ANCOVA|Appetite/Eating Changes Domain. SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.513
71763807|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.16|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 36|||||
71763808|NCT01584440|143029301|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.24|||||TWO_SIDED||||||||Appetite/Eating Changes Domain; Day 70|||||
71825811|NCT00813488|143156239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5118||||0.0012||95.0|1.2|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.2|0.0012
71825812|NCT00813488|143156240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5826||||0.0074|TWO_SIDED|95.0|1.1|2.2|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.2|1.1|0.0074
71825813|NCT00813488|143156241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.059||||0.8444|TWO_SIDED|95.0|0.6|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.6|0.8444
71825814|NCT00813488|143156242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6033|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
71705321|NCT03300336|142928687|SUPERIORITY||Mean Difference (Net)|1.32||||0.52|TWO_SIDED|95.0|-2.7|5.33||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||5.33|-2.70|0.52
71705322|NCT03300336|142928688|SUPERIORITY||Mean Difference (Net)|1.56||||0.66|TWO_SIDED|95.0|-3.14|6.25||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 18 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||6.25|-3.14|0.66
71705323|NCT03300336|142928689|SUPERIORITY||Mean Difference (Net)|-0.52||||0.81|TWO_SIDED|95.0|-4.74|3.7||a priori threshold for significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect.. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care group: 5 out of 227 Missing data due to item nonresponse in intervention group: 14 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.70|-4.74|0.81
71705324|NCT03300336|142928690|SUPERIORITY||Odds Ratio (OR)|1.13||||0.74|TWO_SIDED|95.0|0.55|2.32||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 0 out of 227 Missing data due to item nonresponse in intervention: 5 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||2.32|0.55|0.74
71705325|NCT03300336|142928691|SUPERIORITY||Mean Difference (Net)|0.02||||0.4|TWO_SIDED|95.0|-0.03|0.06||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 14 out of 227 Missing data due to item nonresponse in intervention: 33 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.06|-0.03|0.40
71705326|NCT03300336|142928692|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.07||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 7 out of 227 Missing data due to item nonresponse in intervention: 23 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||0.07|-0.01|0.18
71705327|NCT03300336|142928693|SUPERIORITY||Mean Difference (Net)|0.8||||0.83|TWO_SIDED|95.0|-6.38|7.98||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 4 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||7.98|-6.38|0.83
71763809|NCT01584440|143029302|SUPERIORITY||OLS Z-statistic|-3.53|||<=|0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||<=0.001
71763810|NCT01584440|143029302|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.01|||||TWO_SIDED||||||||Day 36|||||
71653474|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.15|<.0001
71653475|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0004|TWO_SIDED|95.0|-0.91|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-0.91|0.0004
71653476|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.31|<.0001
71763811|NCT01584440|143029302|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.49|||||TWO_SIDED||||||||Day 70|||||
71763812|NCT01584440|143029303|SUPERIORITY||OLS Z-statistic|-3.34||||0.001|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.001
71763813|NCT01584440|143029303|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.41|||||TWO_SIDED||||||||Day 36|||||
71763814|NCT01584440|143029303|SUPERIORITY||ANCOVA Least Squares Mean Difference|-3.94|||||TWO_SIDED||||||||Day 70|||||
71763815|NCT01584440|143029304|SUPERIORITY||OLS Z-statistic|-2.46||||0.014|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.014
71763816|NCT01584440|143029304|SUPERIORITY||ANCOVA Least Squares Mean Difference|-2.65|||||TWO_SIDED||||||||Day 36|||||
71763817|NCT01584440|143029304|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.01|||||TWO_SIDED||||||||||Day 70|||
71763818|NCT01584440|143029305|SUPERIORITY||OLS Z-statistic|-2.57||||0.01|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.010
71763819|NCT01584440|143029305|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.68|||||TWO_SIDED||||||||Day 36|||||
71763820|NCT01584440|143029305|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.2|||||TWO_SIDED||||||||Day 70|||||
71763821|NCT01584440|143029306|SUPERIORITY||OLS Z-statistic|-3.08||||0.002|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.002
71763822|NCT01584440|143029306|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.56|||||TWO_SIDED||||||||Day 36|||||
71763823|NCT01584440|143029306|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.9|||||TWO_SIDED||||||||Day 70|||||
71763824|NCT01584440|143029307|SUPERIORITY||OLS Z-statistic|-2.66||||0.008|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.008
71763825|NCT01584440|143029307|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.43|||||TWO_SIDED||||||||Day 36|||||
71763826|NCT01584440|143029307|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.75|||||TWO_SIDED||||||||Day 70|||||
71763827|NCT01584440|143029308|SUPERIORITY||OLS Z-statistic|-1.96||||0.05|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.050
71763828|NCT01584440|143029308|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.62|||||TWO_SIDED||||||||Day 36|||||
71763829|NCT01584440|143029308|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.3|||||TWO_SIDED||||||||Day 70|||||
71763830|NCT01584440|143029309|SUPERIORITY||OLS Z-statistic|-2.33||||0.02|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.020
71763831|NCT01584440|143029309|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.57|||||TWO_SIDED||||||||Day 36|||||
71763832|NCT01584440|143029309|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.18|||||TWO_SIDED||||||||Day 70|||||
71763833|NCT01584440|143029310|SUPERIORITY||OLS Z-statistic|1.94||||0.053|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.053
71763834|NCT01584440|143029310|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.52|||||TWO_SIDED||||||||Day 36|||||
71763835|NCT01584440|143029310|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.84|||||TWO_SIDED||||||||Day 70|||||
71763836|NCT01584440|143029311|SUPERIORITY||OLS Z-statistic|-0.72||||0.469|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Caregiver|||||0.469
71763837|NCT01584440|143029311|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.28|||||TWO_SIDED||||||||Caregiver: Day 36|||||
71763838|NCT01584440|143029311|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.06|||||TWO_SIDED||||||||Caregiver: Day 70|||||
71763839|NCT01584440|143029311|SUPERIORITY||OLS Z-statistic|1.41||||0.159|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population|Participant|||||0.159
71763840|NCT01584440|143029311|SUPERIORITY||ANCOVA Least Squares Mean Difference|1.09|||||TWO_SIDED||||||||Participant: Day 36|||||
71763841|NCT01584440|143029311|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.7|||||TWO_SIDED||||||||Participant: Day 70|||||
71763842|NCT01584440|143029312|SUPERIORITY||OLS Z-statistic|-1.4||||0.163|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.163
71763843|NCT01584440|143029312|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.07|||||TWO_SIDED||||||||Day 36|||||
71763844|NCT01584440|143029312|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.39|||||TWO_SIDED||||||||Day 70|||||
71763845|NCT01584440|143029313|SUPERIORITY||OLS Z-statistic|-1.08||||0.279|TWO_SIDED||||||ANCOVA|SPCD: data from the Stages 1 and 2 are analyzed together using the mITT Population||||||0.279
71763846|NCT01584440|143029313|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.76|||||TWO_SIDED||||||||Day 8|||||
71763847|NCT01584440|143029313|SUPERIORITY||ANCOVA Least Squares Mean Difference|-1.02|||||TWO_SIDED||||||||Day 22|||||
71763848|NCT01584440|143029313|SUPERIORITY||ANCOVA Least Squares Mean Difference|0.74|||||TWO_SIDED||||||||Day 43|||||
71763849|NCT01584440|143029313|SUPERIORITY||ANCOVA Least Squares Mean Difference|-0.05|||||TWO_SIDED||||||||Day 57|||||
71763850|NCT01584440|143029314|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0001|TWO_SIDED|95.0|1.62|4.5|||ANCOVA||Day 36|||4.50|1.62|0.0001
71763851|NCT01584440|143029314|SUPERIORITY||Odds Ratio (OR)|1.61||||0.2184|TWO_SIDED|95.0|0.75|3.43|||ANCOVA||Day 70|||3.43|0.75|0.2184
71763852|NCT01584440|143029315|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0266|TWO_SIDED|95.0|1.11|5.42|||ANCOVA|||||5.42|1.11|0.0266
71653477|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.14|<.0001
71653478|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.18|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.18|<.0001
71653479|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-1.00|0.0002
71653480|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.12|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.12|<.0001
71653481|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0013|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.24|-0.99|0.0013
71653482|NCT02709486|142824942|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.25|-0.5|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.25|<.0001
71653483|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.45|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.45|-0.96|<.0001
71653484|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|95.0|-0.73|-0.21|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.73|0.0004
71653485|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.04|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.49|-1.04|<.0001
71653486|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.08|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.53|-1.08|<.0001
71763853|NCT01584440|143029316|SUPERIORITY||Odds Ratio (OR)|2.16||||0.002|TWO_SIDED|95.0|1.31|3.55|||ANCOVA||Day 36|||3.55|1.31|0.002
71763854|NCT01584440|143029316|SUPERIORITY||Odds Ratio (OR)|2.32||||0.031|TWO_SIDED|95.0|1.08|5.0|||ANCOVA||Day 70|||5.00|1.08|0.031
71763855|NCT01584440|143029317|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0048|TWO_SIDED|95.0|1.31|4.46|||ANCOVA|||||4.46|1.31|0.0048
71763856|NCT00531427|143029320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0853|TWO_SIDED|95.0|-0.8|0.05|||Mixed Models Analysis|Statistics are based on a mixed effect general linear model||"\[Week 12 analysis\] The null hypothesis was no group differences. The alternative hypothesis was that BTDS arm was superior to the placebo arm.~Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)."||0.05|-0.80|0.0853
71763857|NCT00531427|143029321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.7098|TWO_SIDED|95.0|-0.233|0.159||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|ANCOVA|with treatment as a factor and screening and pre-randomization mean pain as covariates.||Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took \<=1 dose of supplemental analgesia||0.159|-0.233|0.7098
71763858|NCT00531427|143029322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46||||0.0034|TWO_SIDED|95.0|-7.44|-1.48||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|Mixed Models Analysis|||Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.||-1.48|-7.44|0.0034
71825815|NCT00813488|143156243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3334|||<|0.0001|TWO_SIDED|95.0|1.2|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.5|1.2|<0.0001
71825816|NCT00635817|143156280|SUPERIORITY_OR_OTHER|||||||0.099||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.099
71825817|NCT00635817|143156280|SUPERIORITY_OR_OTHER|||||||0.074||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.074
71825818|NCT00635817|143156280|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.026
71825819|NCT00635817|143156280|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.||||0.102
71653487|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.32|-0.90|<.0001
71763859|NCT05871450|143029393|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
71763860|NCT00776919|143029445|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71825820|NCT00635817|143156281|SUPERIORITY_OR_OTHER|||||||0.008||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.008
71653488|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.13|-0.56|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-1.13|<.0001
71653489|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.09|-0.47|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.09|<.0001
71653490|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.12|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.50|-1.12|<.0001
71653491|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.16||0.0001|TWO_SIDED|95.0|-0.95|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.95|0.0001
71653492|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
71763861|NCT00776919|143029445|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Cochran-Mantel-Haenszel|||||||0.016
71763862|NCT00776919|143029445|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71825821|NCT00635817|143156281|SUPERIORITY_OR_OTHER|||||||0.002||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.002
71825822|NCT00635817|143156281|SUPERIORITY_OR_OTHER|||||||0.347||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.347
71825823|NCT00635817|143156281|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).||||0.150
71705328|NCT03300336|142928694|SUPERIORITY||Mean Difference (Net)|1.46||||0.25|TWO_SIDED|95.0|-1.05|3.96||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention: 6 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.96|-1.05|0.25
71705329|NCT03300336|142928695|SUPERIORITY||Odds Ratio (OR)|1.16||||0.59|TWO_SIDED|95.0|0.68|1.99||a priori threshold for statistical significance p\<.05|generalized linear model|generalized linear model with a logit link and a binomial distribution|Odds in intervention numerator vs odds in usual care denominator|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 1 out of 227 Missing data due to item nonresponse in intervention: 3 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.99|0.68|0.59
71763863|NCT00776919|143029446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71763864|NCT00776919|143029446|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.015
71763865|NCT00776919|143029446|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71763866|NCT00776919|143029447|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71763867|NCT00776919|143029447|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.102
71763868|NCT00776919|143029447|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71763869|NCT00776919|143029448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71763870|NCT00776919|143029448|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||0.032
71763871|NCT00776919|143029448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA|||||||<0.001
71763872|NCT03116152|143029459|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.032|TWO_SIDED|95.0|0.504|0.972|||Log Rank|||||0.972|0.504|0.032
71763873|NCT03116152|143029460|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.979|TWO_SIDED|95.0|0.722|1.391|||Log Rank|||||1.391|0.722|0.979
71763874|NCT03116152|143029461|SUPERIORITY||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-2.2|15.4||||||||15.4|-2.2|
71763875|NCT03116152|143029462|SUPERIORITY|||||||0.345|||||||Log Rank|||||||0.345
71763876|NCT02448641|143029466|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6743|TWO_SIDED|95.0|0.35|5.09||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.09|0.35|0.6743
71763877|NCT02448641|143029467|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1|TWO_SIDED|95.0|0.15|1.18||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with mRS responder as outcome, treatment, visit, treatment-visit interaction, pooled site and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||1.18|0.15|0.1000
71763878|NCT02448641|143029470|SUPERIORITY||Mean Difference (Net)|-0.36||||0.7788|TWO_SIDED|95.0|-2.9|2.17||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): -0.36 (1.283)|Statistical analysis: NeuroQOL score for the Upper Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.17|-2.90|0.7788
71763879|NCT02448641|143029470|SUPERIORITY||Mean Difference (Net)|0.58||||0.5347|TWO_SIDED|95.0|-1.26|2.43||Combined SB623 vs. Sham at month 6 MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 0.58 (0.934)|Statistical Analysis: NeuroQOL score for Lower Extremity Function (Represents Mean Change from Baseline in T-Scores at Month 6)||2.43|-1.26|0.5347
71763880|NCT02448641|143029472|SUPERIORITY||Mean Difference (Net)|1.2||||0.2959|TWO_SIDED|95.0|-1.1|3.6||MMRM: Mixed effect Model Repeat Measurement|Mixed Models Analysis|MMRM included treatment, visit, pooled site, corresponding Baseline sub-domain T-score, Baseline mRS score, and the treatment-by-visit interaction|LSMD (Least square mean difference) (SE): 1.2 (1.18)|"Change from Baseline at Month 6~Between-group Effect size is calculated as the LS mean difference divided by the model estimate of the pooled SD, obtained from the square root of the diagonal element, associated with the analysis visit summarized, from the covariance matrix."||3.6|-1.1|0.2959
71763881|NCT02448641|143029473|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6854|TWO_SIDED|95.0|0.31|5.92||GLMM: Generalized Linear Mixed Model|Mixed Models Analysis|A GLMM with FMMS responder as outcome, treatment, visit, treatment-visit interaction, pooled site, Baseline FMMS and Baseline mRS scores as covariates||Combined SB623 Implant Vs Sham Surgery group at Month 6||5.92|0.31|0.6854
71763882|NCT02878798|143029475|OTHER|Non-inferiority and superiority tests were completed|Slope|0.2105|||||ONE_SIDED|95.0|-0.4328||||||||||-0.4328|
71763883|NCT02878798|143029476|OTHER|Non-inferiority and superiority tests were done|Slope|-1.5219|||||ONE_SIDED|95.0||1.1933||||||||1.1933||
71763884|NCT02878798|143029477|SUPERIORITY||Slope|-0.02322|||||TWO_SIDED|95.0|-0.6337|0.5872|||Mixed Models Analysis|||||0.5872|-0.6337|
71825824|NCT00708097|143156288|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.98||||0.5757|TWO_SIDED|95.0|-5.0|8.97||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.97|-5.00|0.5757
71825825|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.5387|TWO_SIDED|95.0|-4.79|9.14||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.14|-4.79|0.5387
71825826|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.79||||0.4306|TWO_SIDED|95.0|-4.18|9.77||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.77|-4.18|0.4306
71705330|NCT03300336|142928696|SUPERIORITY||Mean Difference (Net)|0.99||||0.47|TWO_SIDED|95.0|-1.71|3.69||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 11 out of 227 Missing data due to item nonresponse in intervention: 20 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||3.69|-1.71|0.47
71705331|NCT03300336|142928697|SUPERIORITY||Mean Difference (Net)|-0.07||||0.94|TWO_SIDED|95.0|-1.76|1.62||a priori threshold for statistical significance p\<.05|Mixed Models Analysis||Estimated difference calculated as intervention minus control|"Model included a time-varying indicator for when STRIDE program launched, fixed effects for time (indicator variables for each of the time periods) and a site-level random effect. Model was not adjusted for patient characteristics.~Missing data due to item nonresponse in usual care: 2 out of 227 Missing data due to item nonresponse in intervention group: 7 out of 399~Estimated means and standard errors are provided in Outcome Measure Data table."||1.62|-1.76|0.94
71705332|NCT00710554|142928699|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.34||||0.139|TWO_SIDED|95.0|-0.79|0.11|||ANCOVA|||The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.11|-0.79|0.139
71763885|NCT02878798|143029478|SUPERIORITY||Slope|-0.168||||0.261|TWO_SIDED|95.0|-0.4612|0.1253|||Mixed Models Analysis|||||0.1253|-0.4612|0.261
71705333|NCT00710554|142928700|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.86||||0.198|TWO_SIDED|95.0|-7.22|1.5|||ANCOVA|||The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||1.50|-7.22|0.198
71763886|NCT02878798|143029479|SUPERIORITY||Slope|-0.061||||0.9007|TWO_SIDED|95.0|-1.0213|0.8992|||Mixed Models Analysis|||||0.8992|-1.0213|0.9007
71763887|NCT02878798|143029480|SUPERIORITY||Slope|0.0106||||0.8174|TWO_SIDED|95.0|-0.0793|0.1005|||Hurdle model|||||0.1005|-0.0793|0.8174
71763888|NCT02878798|143029481|SUPERIORITY||Slope|-0.7394||||0.0233|TWO_SIDED|95.0|-1.3775|-0.1013|||Mixed Models Analysis|||||-0.1013|-1.3775|0.0233
71763889|NCT02878798|143029482|SUPERIORITY||Slope|-0.1328||||0.7586|TWO_SIDED|95.0|-0.982|0.7164|||Mixed Models Analysis|||||0.7164|-0.982|0.7586
71763890|NCT02878798|143029483|SUPERIORITY||Slope|-0.0021||||0.9604|TWO_SIDED|95.0|-0.084|0.0799|||Mixed Models Analysis|||||0.0799|-0.084|0.9604
71763891|NCT02878798|143029484|SUPERIORITY||Slope|-0.0396||||0.2365|TWO_SIDED|95.0|-0.1053|0.0261|||Mixed Models Analysis|||||0.0261|-0.1053|0.2365
71763892|NCT02878798|143029485|SUPERIORITY||Slope|2.3848||||0.5813|TWO_SIDED|95.0|-6.1336|10.9032|||Mixed Models Analysis|||||10.9032|-6.1336|0.5813
71763893|NCT02878798|143029486|SUPERIORITY||Slope|-1.0547||||0.4092|TWO_SIDED|95.0|-3.5705|1.4611|||Mixed Models Analysis|||||1.4611|-3.5705|0.4092
71763894|NCT02259088|143029500|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.8|||<|0.001|TWO_SIDED|95.0|4.1|7.5|||Cochran-Mantel-Haenszel|One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics.|Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and \> 60 letters) as factors.|||7.5|4.1|<0.001
71763895|NCT01818752|143029529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.159|TWO_SIDED|95.0|0.746|1.101||The p-value boundary for PFS analysis was 0.02141.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.||1.101|0.746|0.1590
71705334|NCT00710554|142928701|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.83||||0.007|TWO_SIDED|95.0|-1.43|-0.23|||ANCOVA|||The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||-0.23|-1.43|0.007
71705335|NCT00710554|142928702|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.08||||0.795|TWO_SIDED|95.0|-0.52|0.68|||ANCOVA|||The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.68|-0.52|0.795
71705336|NCT00710554|142928703|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.233|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.||0.09|-0.37|0.233
71705337|NCT00710554|142928704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.762||||0.023|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.||2.88|1.08|0.023
71705338|NCT00710554|142928705|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.25||||0.288|TWO_SIDED|95.0|-0.72|0.21|||ANCOVA|||The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||0.21|-0.72|0.288
71705339|NCT00710554|142928706|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.01||||0.617|TWO_SIDED|95.0|-0.06|0.04|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||0.04|-0.06|0.617
71705340|NCT00710554|142928707|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|2.459||0.76|TWO_SIDED|95.0|-5.6|4.09|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.||4.09|-5.60|0.76
71705341|NCT00710554|142928708|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.38||||0.112|TWO_SIDED|95.0|-0.85|0.09|||ANCOVA|||The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.||0.09|-0.85|0.112
71705342|NCT00378560|142928711|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|87.6|||||TWO_SIDED|95.0|59.2|97.6|||||Binomial probability conditional on the fixed number of events.|||97.6|59.2|
71705343|NCT00378560|142928712|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705344|NCT00378560|142928713|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705345|NCT00378560|142928714|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71705346|NCT00378560|142928715|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71775032|NCT02600351|143050162|NON_INFERIORITY|With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.|Difference in percentages|-11.7||||0.25|TWO_SIDED|95.0|-32.1|8.8|||Cochran-Mantel-Haenszel|||||8.8|-32.1|0.25
71705347|NCT03203512|142928721|SUPERIORITY||||||<|0.001||||||Treatment effect: p\<0.001; period effect : p=0.552; treatment x period interaction: p=0.622|ANOVA|||Null hypothesis is that there was no difference in change of total EV numbers detected by NTA between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total EV numbers.||||<0.001
71705348|NCT03203512|142928722|SUPERIORITY||||||=|0.001||||||Treatment: p=0.001; period: p=0.646; treatment x period interaction: p=0.267|ANOVA|||Null hypothesis is that there was no difference in change of total PS+EV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total PS+EV numbers.||||=0.001
71705349|NCT03203512|142928723|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.350; treatment x period interaction: p=0.572|ANOVA|||Null hypothesis is that there was no difference in change of PDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on PDEV numbers.||||=0.002
71705350|NCT03203512|142928723|SUPERIORITY|Null hypothesis is that there was no difference in change of EDEV numbers detected by FCM between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EDEV numbers.|||||<|0.001||||||Treatment: p\<0.001; period: p=0.362; treatment x period interaction: p=0.225|ANOVA|||||||<0.001
71705351|NCT03203512|142928724|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.010; treatment x period: p=0.608|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting lag time for TF-dependent thrombin generation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71705352|NCT03203512|142928725|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.073; treatment x period: p=0.667|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent thrombin peak concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71705353|NCT03203512|142928726|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.138; treatment x period: p=0.872|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting the time to reach peak TF-dependent thrombin concentration between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71705354|NCT03203512|142928727|SUPERIORITY||||||=|0.015||||||Treatment: p=0.015; period: p=0.059; treatment x period: p=0.220|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent velocity index between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||=0.015
71705355|NCT03203512|142928728|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.118; treatment x period: p=0.802|ANOVA|||Null hypothesis is that there was no difference in change of EV thrombogenicity in affecting TF-dependent endogenous thrombin potential (ETP) between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EV thrombogenicity.||||<0.001
71705356|NCT03203512|142928729|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to ADP between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
71705357|NCT03203512|142928729|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to epinephrine between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
71705358|NCT03203512|142928729|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to TRAP-6 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
71705359|NCT03203512|142928729|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to U46619 between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
71705360|NCT03203512|142928730|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of platelet function in affecting LogEC50 values in response to CRP-XL between fish oil and placebo capsules. Comparisons of this parameter after each intervention were drawn using 2-way ANOVA with the Turkey multiple comparisons test.||||>0.05
71705361|NCT03203512|142928731|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting endpoint for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
71763896|NCT01818752|143029530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.211||||0.8934|TWO_SIDED|95.0|0.896|1.637||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.637|0.896|0.8934
71705362|NCT03203512|142928731|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affectingamximum for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
71705363|NCT03203512|142928732|SUPERIORITY||||||>|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of pro-thrombotic activity of PDEVs in affecting area under curve for ex vivo thrombus formation between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on the pro-thrombotic activity of PDEVs.||||>0.05
71705364|NCT03203512|142928733|SUPERIORITY||||||<|0.001||||||Treatment: \<0.001; period: p=0.978; treatment x period interaction: p=0.140|ANOVA|||Null hypothesis is that there was no difference in change of EPA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in circulating EV total lipids.||||<0.001
71705365|NCT03203512|142928733|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.699; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DHA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in circulating EV total lipids.||||<0.001
71705366|NCT03203512|142928733|SUPERIORITY||||||=|0.011||||||Treatment: p=0.011; period: p=0.381; treatment x period interaction: p=0.762|ANOVA|||Null hypothesis is that there was no difference in change of oleic acid in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on oleic acid in circulating EV total lipids.||||=0.011
71705367|NCT03203512|142928733|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.512; treatment x period interaction: p=0.812|ANOVA|||Null hypothesis is that there was no difference in change of AA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in circulating EV total lipids.||||<0.001
71705368|NCT03203512|142928733|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.160; treatment x period interaction: p=0.132|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in circulating EV total lipids.||||<0.001
71825827|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.07|||<|0.0001|TWO_SIDED|95.0|-32.09|-18.06||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-18.06|-32.09|<0.0001
71705369|NCT03203512|142928733|SUPERIORITY||||||=|0.013||||||Treatment: p=0.013; period: p=0.500; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of total MUFA in circulating EV total lipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total MUFA in circulating EV total lipids.||||=0.013
71705370|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.169; treatment x period interaction: p=0.629|ANOVA|||Null hypothesis is that there was no difference in change of EPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on EPA in plasma total phospholipids.||||<0.001
71763897|NCT01818752|143029531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.412||||0.0218|TWO_SIDED|95.0|1.01|1.973||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.973|1.010|0.0218
71763898|NCT01818752|143029532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.1388|TWO_SIDED|95.0|0.875|1.589||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.|||1.589|0.875|0.1388
71763899|NCT01818752|143029533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.048|||<|0.0001|TWO_SIDED|95.0|0.026|0.088||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Pearson Chi-Square test||Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.|||0.088|0.026|< 0.0001
71763900|NCT01818752|143029534|SUPERIORITY_OR_OTHER||Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|0.773|<|0.0001|TWO_SIDED|95.0|3.48|6.51||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Mixed Effects Model for Repeated Measure|||Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors - ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.||6.51|3.48|< 0.0001
71763901|NCT03009396|143029566|SUPERIORITY|||||||0.2112|||||||Log Rank|||||||0.2112
71763902|NCT03009396|143029567|SUPERIORITY|||||||0.0356|||||||Log Rank|||||||0.0356
71763903|NCT03009396|143029568|SUPERIORITY|||||||0.0514|||||||Log Rank|||||||0.0514
71763904|NCT03009396|143029569|SUPERIORITY|||||||0.1259|||||||Log Rank|||||||0.1259
71763905|NCT03009396|143029570|SUPERIORITY|||||||0.4114|||||||Fisher Exact|||||||0.4114
71705371|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.262; treatment x period interaction: p=0.150|ANOVA|||Null hypothesis is that there was no difference in change of DHA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DHA in plasma total phospholipids.||||<0.001
71763906|NCT02872285|143029574|SUPERIORITY||Mean Difference (Final Values)|-12.8||||0.2205|TWO_SIDED|95.0|-33.793|8.199||ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.|ANCOVA|||Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.||8.199|-33.793|0.2205
71763907|NCT02872285|143029575|SUPERIORITY|||||||0.4712|||||||Chi-squared|2-sided p-value.||||||0.4712
71763908|NCT02872285|143029576|SUPERIORITY||Mean Difference (Final Values)|-5.34||||0.6695|TWO_SIDED|95.0|-30.87|20.18|||ANCOVA|||||20.18|-30.87|0.6695
71763909|NCT02872285|143029577|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
71763910|NCT02872285|143029578|SUPERIORITY|||||||0.4712||||||2-sided p-value|Chi-squared|||||||0.4712
71763911|NCT05477108|143029579|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 42.91. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1028 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|104.24|||||TWO_SIDED|90.0|95.78|113.44|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||113.44|95.78|
71763912|NCT05477108|143029579|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.85. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0831 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.45|||||TWO_SIDED|90.0|84.31|103.58|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||103.58|84.31|
71825828|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19||||0.9567|TWO_SIDED|95.0|-6.71|7.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.09|-6.71|0.9567
71825829|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.81||||0.8188|TWO_SIDED|95.0|-6.14|7.76||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.76|-6.14|0.8188
71825830|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.06|||<|0.0001|TWO_SIDED|95.0|-34.03|-20.08||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.08|-34.03|<0.0001
71886542|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.12|=|0.4842|TWO_SIDED|95.0|-5.7|2.7|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||2.7|-5.7|=0.4842
71705372|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.302; treatment x period interaction: p=0.385|ANOVA|||Null hypothesis is that there was no difference in change of DPA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DPA in plasma total phospholipids.||||<0.001
71705373|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.793; treatment x period interaction: p=0.522|ANOVA|||Null hypothesis is that there was no difference in change of linoleic acid in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on linoleic acid in plasma total phospholipids.||||<0.001
71705374|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.956; treatment x period interaction: p=0.238|ANOVA|||Null hypothesis is that there was no difference in change of dihomo-γ-linolenic acid (DGLA) in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DGLA in plasma total phospholipids.||||<0.001
71705375|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.457; treatment x period interaction: p=0.613|ANOVA|||Null hypothesis is that there was no difference in change of AA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on AA in plasma total phospholipids.||||<0.001
71705376|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.134; treatment x period interaction: p=0.260|ANOVA|||Null hypothesis is that there was no difference in change of total n-3 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-3 PUFA in plasma total phospholipids.||||<0.001
71705377|NCT03203512|142928734|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period: p=0.917; treatment x period interaction: p=0.603|ANOVA|||Null hypothesis is that there was no difference in change of total n-6 PUFA in plasma total phospholipids between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on total n-6 PUFA in plasma total phospholipids.||||<0.001
71705378|NCT03203512|142928735|SUPERIORITY||||||=|0.016||||||Treatment: p=0.016; period: p=0.566; treatment x period interaction: p=0.659|ANOVA|||Null hypothesis is that there was no difference in change of plasma TAG between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TAG.||||=0.016
71705379|NCT03203512|142928735|SUPERIORITY||||||=|0.014||||||Treatment: p=0.014; period: p=0.842; treatment x period interaction: p=0.943|ANOVA|||Null hypothesis is that there was no difference in change of plasma LDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma LDL-C.||||=0.014
71705380|NCT03203512|142928735|SUPERIORITY||||||=|0.077||||||Treatment: p=0.077; period: p=0.921; treatment x period interaction: p=0.793|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC.||||=0.077
71705381|NCT03203512|142928735|SUPERIORITY||||||=|0.379||||||Treatment: p=0.379; period: p=0.938; treatment x period interaction: p=0.341|ANOVA|||Null hypothesis is that there was no difference in change of plasma HDL-C between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma HDL-C.||||=0.379
71705382|NCT03203512|142928736|SUPERIORITY||||||=|0.285||||||Treatment: p=0.285; period: p=0.954; treatment x period interaction: p=0.528|ANOVA|||Null hypothesis is that there was no difference in change of plasma TC/HDL-C ratio between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on plasma TC/HDL-C ratio.||||=0.285
71763913|NCT05477108|143029579|EQUIVALENCE|For Cmax, the intra-participant CV% in Treatment B (reference arm) was 40.66. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0971 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|100.14|||||TWO_SIDED|90.0|91.9|109.11|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||109.11|91.90|
71763914|NCT05477108|143029579|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 42.66. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 73.29% to 136.44% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|103.12|||||TWO_SIDED|90.0|94.44|112.6|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||112.60|94.44|
71763915|NCT05477108|143029579|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.75. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.24% to 134.70% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|93.39|||||TWO_SIDED|90.0|85.29|102.26|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||102.26|85.29|
71763916|NCT05477108|143029579|EQUIVALENCE|For Cmax, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. The intra-participant CV% in Treatment B (reference arm) was 40.81. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were within the expanded equivalence limits of 74.21% to 134.75% and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|99.7|||||TWO_SIDED|90.0|91.44|108.71|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||108.71|91.44|
71763917|NCT05477108|143029580|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 34.29. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0593 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|100.35|115.72|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.72|100.35|
71775033|NCT02556203|143050176|NON_INFERIORITY|1-sided Confidence interval|Hazard Ratio (HR)|1.2089302|||||ONE_SIDED|97.5||1.7040824||||||"H0: HR(t)\>=1.20 for all time points t\>=0, (i.e. the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group)"||1.7040824||
71775034|NCT02556203|143050177|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.35|||=|0.04223|TWO_SIDED|95.0|1.01|1.81|||Log Rank|||||1.81|1.01|= 0.04223
71775035|NCT02556203|143050178|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.5|||=|0.07745|TWO_SIDED|95.0|0.95|2.37|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.37|0.95|= 0.07745
71775036|NCT02556203|143050179|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.39|||=|0.01156|TWO_SIDED|95.0|1.08|1.8|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.80|1.08|= 0.01156
71705383|NCT03203512|142928737|SUPERIORITY||||||<|0.001||||||Treatment: p\<0.001; period effect: p=0.011; treatment x period interaction: p=0.033|ANOVA|||Null hypothesis is that there was no difference in change of SBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on SBP.||||<0.001
71775037|NCT02556203|143050180|SUPERIORITY|2-sided Log Rank test|Hazard Ratio (HR)|1.22|||=|0.21595|TWO_SIDED|95.0|0.89|1.69|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||1.69|0.89|= 0.21595
71775038|NCT02556203|143050181|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.78|||=|0.02216|TWO_SIDED|95.0|1.08|2.94|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.94|1.08|= 0.02216
71775039|NCT02556203|143050182|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.66|||=|0.02702|TWO_SIDED|95.0|1.05|2.62|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.62|1.05|= 0.02702
71705384|NCT03203512|142928737|SUPERIORITY||||||=|0.002||||||Treatment: p=0.002; period: p=0.952; treatment x period interaction: p=0.114|ANOVA|||Null hypothesis is that there was no difference in change of DBP between fish oil and placebo capsules. A general linear model with fixed factors of treatment and period was conducted to determine the differences in the effect of two treatments and two periods on DBP.||||=0.002
71705385|NCT02933476|142928750|SUPERIORITY||||||>|0.05|||||||ANOVA|||We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.||||>0.05
71705386|NCT02933476|142928751|SUPERIORITY|||||||0.008|||||||ANOVA|||||||0.008
71705387|NCT02933476|142928752|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71705388|NCT00191152|142928802|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
71705389|NCT00191152|142928803|SUPERIORITY_OR_OTHER|||||||0.361||95.0|||||Log Rank|||||||0.361
71705390|NCT00191152|142928804|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Log Rank|||||||0.145
71705391|NCT00191152|142928805|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Log Rank|||||||0.385
71705392|NCT00191152|142928806|SUPERIORITY_OR_OTHER|||||||0.377||95.0|||||Log Rank|||||||0.377
71705393|NCT00191152|142928807|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Log Rank|||||||0.446
71763918|NCT05477108|143029580|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 86.08. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2925 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Ratio Mean (%)|112.22|||||TWO_SIDED|90.0|92.27|136.49|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||136.49|92.27|
71775040|NCT02556203|143050183|OTHER|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.84|||=|1e-05|TWO_SIDED|95.0|1.41|2.41|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs \>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.|||2.41|1.41|= 0.00001
71653493|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.0015|TWO_SIDED|95.0|-0.89|-0.21|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.89|0.0015
71653494|NCT02709486|142824944|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.07|-0.39|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.07|<.0001
71653495|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.96|-0.38|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.38|-0.96|<.0001
71653496|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.67|-0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.67|0.0139
71653497|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.13|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.13|<.0001
71653498|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.55|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.16|<.0001
71653499|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.91|-0.27|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.91|0.0003
71705394|NCT00191152|142928808|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Log Rank|||||||0.785
71705395|NCT00191152|142928809|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Fisher Exact|||||||0.364
71705396|NCT00191152|142928810|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||||||0.446
71705397|NCT00191152|142928811|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Mixed Models Analysis|||||||0.990
71705398|NCT00191152|142928812|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Mixed Models Analysis|||||||0.117
71705399|NCT00191152|142928813|SUPERIORITY_OR_OTHER|||||||0.801||95.0|||||Mixed Models Analysis|||||||0.801
71705400|NCT00191152|142928814|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Mixed Models Analysis|||||||0.190
71705401|NCT00114777|142928824|SUPERIORITY_OR_OTHER||Treament Difference|1.1|||||TWO_SIDED|97.3|-7.2|9.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||9.4|-7.2|
71705402|NCT00114777|142928824|SUPERIORITY_OR_OTHER||Treatment difference|3.2|||||TWO_SIDED|97.3|-5.0|11.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).|||11.4|-5.0|
71705403|NCT00114777|142928825|SUPERIORITY_OR_OTHER||Percentage difference|-14.4||||0.0018|TWO_SIDED|97.3|-24.0|-4.7|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||-4.7|-24|0.0018
71705404|NCT00114777|142928825|SUPERIORITY_OR_OTHER||Percentage difference|-8.5||||0.0616|TWO_SIDED|97.3|-18.0|0.9|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.|||0.9|-18|0.0616
71705405|NCT00682838|142928869|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 1 sided|||||||0.50
71705406|NCT03566550|142928875|OTHER|||||||0.04|||||||Log Rank|||||||0.04
71705407|NCT03566550|142928876|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71705408|NCT03566550|142928877|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71775041|NCT01925274|143050216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.71||||0.164|TWO_SIDED|95.0|-83.4|12.0|||Chi-squared|||||12.0|-83.4|0.164
71705409|NCT03566550|142928878|OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71705410|NCT03566550|142928879|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71705411|NCT02618187|142928885|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.766|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.766
71705412|NCT02618187|142928885|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.037|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.037
71705413|NCT02618187|142928885|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.313|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.313
71705414|NCT02618187|142928885|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.384|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.384
71705415|NCT02618187|142928885|OTHER|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.237|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.237
71705416|NCT02618187|142928886|SUPERIORITY|Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority||||||0.257|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.257
71705417|NCT02618187|142928886|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
71705418|NCT02618187|142928886|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.001
71705419|NCT02618187|142928886|SUPERIORITY|Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority||||||0.009|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.009
71763919|NCT05477108|143029580|EQUIVALENCE|For AUCinf, the intra-participant CV% in Treatment B (reference arm) was 47.07. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.1250 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|101.45|||||TWO_SIDED|90.0|91.76|112.15|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||112.15|91.76|
71763920|NCT05477108|143029581|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 35.68. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.0668 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|106.87|||||TWO_SIDED|90.0|99.3|115.01|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (US approach)||115.01|99.30|
71705420|NCT02618187|142928886|SUPERIORITY|Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority||||||0.168|||||||Wilcoxon (Mann-Whitney)|1-sided||||||0.168
71705421|NCT02618187|142928887|SUPERIORITY||Rate difference (SER-287 - placebo)|13.3||||0.4923|TWO_SIDED|95.0|-3.87|30.54|||Fisher Exact|||||30.54|-3.87|0.4923
71705422|NCT02618187|142928887|SUPERIORITY||Rate difference (SER-287 - placebo)|40.0||||0.0237|TWO_SIDED|95.0|15.21|64.79|||Fisher Exact|||||64.79|15.21|0.0237
71705423|NCT02618187|142928887|SUPERIORITY||Rate difference (SER-287 - placebo)|17.6||||0.2579|TWO_SIDED|95.0|-0.47|35.77|||Fisher Exact|||||35.77|-0.47|0.2579
71705424|NCT02618187|142928888|SUPERIORITY||Rate difference (SER-287 - placebo)|24.2||||0.1973|TWO_SIDED|95.0|-5.04|53.53|||Fisher Exact|||||53.53|-5.04|0.1973
71705425|NCT02618187|142928888|SUPERIORITY||Rate difference (SER-287 - placebo)|30.9||||0.1783|TWO_SIDED|95.0|0.86|60.96|||Fisher Exact|||||60.96|0.86|0.1783
71705426|NCT02618187|142928888|SUPERIORITY||Rate difference (SER-287 - placebo)|14.4||||0.6195|TWO_SIDED|95.0|-11.93|40.81|||Fisher Exact|||||40.81|-11.93|0.6195
71705427|NCT03467945|142928962|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.4421|||||TWO_SIDED|90.0|75.2805|88.1079||||||||88.1079|75.2805|
71705428|NCT03467945|142928962|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
71705429|NCT03467945|142928962|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
71705430|NCT03467945|142928963|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
71705431|NCT03467945|142928963|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.7255|||||TWO_SIDED|90.0|101.1665|110.49||||||||110.4900|101.1665|
71705432|NCT03467945|142928963|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.7533|||||TWO_SIDED|90.0|92.5812|101.1135||||||||101.1135|92.5812|
71705433|NCT03467945|142928964|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|77.6923|||||TWO_SIDED|90.0|70.383|85.7606||||||||85.7606|70.3830|
71705434|NCT03467945|142928964|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
71705435|NCT03467945|142928964|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|79.4367|||||TWO_SIDED|90.0|71.9633|87.6861||||||||87.6861|71.9633|
71705436|NCT03467945|142928965|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||TWO_SIDED|90.0|102.237|114.2609||||||||114.2609|102.2370|
71705437|NCT03467945|142928965|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|93.6828|||||TWO_SIDED|90.0|88.6166|99.0386||||||||99.0386|88.6166|
71705438|NCT03467945|142928965|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|115.37|||||TWO_SIDED|90.0|109.131|121.9658||||||||121.9658|109.1310|
71705439|NCT03467945|142928966|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|82.6022|||||TWO_SIDED|90.0|76.5513|89.1314||||||||89.1314|76.5513|
71705440|NCT03467945|142928966|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.8819|106.9028||||||||106.9028|97.8819|
71705441|NCT03467945|142928966|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||TWO_SIDED|90.0|74.8823|87.6417||||||||87.6417|74.8823|
71705442|NCT03467945|142928967|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||TWO_SIDED|90.0|97.5947|106.2906||||||||106.2906|97.5947|
71705443|NCT03467945|142928967|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.915|||||TWO_SIDED|90.0|101.49|110.533||||||||110.5330|101.4900|
71705444|NCT03467945|142928967|EQUIVALENCE|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.1619|||||TWO_SIDED|90.0|92.1443|100.3546||||||||100.3546|92.1443|
71705445|NCT05103332|142929022|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|95.0|-16.5|-7.6||MMRM: Fixed factors: treatment, visit, treatment-by-visit interaction, race (black/all other races); Covariates: Baseline (BA) 24-hour mean SBP using ABPM \& BA estimated glomerular filtration rate (eGFR). Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-7.6|-16.5|<0.0001
71705446|NCT05103332|142929023|SUPERIORITY||Difference in LS Mean|-9.7|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|-12.9|-6.6||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.6|-12.9|<0.0001
71705447|NCT05103332|142929024|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.89|=|0.0183|TWO_SIDED|95.0|-8.2|-0.8||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort \& handle primary \& key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for SBP, assessed using ABPM, while participants were on \& within 2 weeks after stopping any escape medication were censored for this endpoint.||-0.8|-8.2|=0.0183
71705448|NCT05103332|142929025|SUPERIORITY||Difference in LS Mean|-18.5|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-22.8|-14.2||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-14.2|-22.8|<0.0001
71705449|NCT05103332|142929026|SUPERIORITY||Difference in LS Mean|-11.0|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-14.7|-7.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-7.3|-14.7|<0.0001
71738954|NCT03637517|142990706|EQUIVALENCE|2 comparisons performed: Reg. B vs. Reg. A, \& Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.79||||0.037|TWO_SIDED|90.0|0.658|0.95|||ANOVA|||||0.950|0.658|0.0370
71775042|NCT00777205|143050269|SUPERIORITY_OR_OTHER||Slope|0.22|||<|0.05|TWO_SIDED|95.0|-1.57|2.01|||Mixed Models Analysis|||||2.01|-1.57|<0.05
71775043|NCT00777205|143050270|SUPERIORITY_OR_OTHER||Slope|-0.39|||<|0.05|TWO_SIDED|95.0|-2.03|1.24|||Mixed Models Analysis|||||1.24|-2.03|<0.05
71775044|NCT00777205|143050271|SUPERIORITY_OR_OTHER||Slope|0.81|||<|0.05|TWO_SIDED|95.0|-0.93|2.55|||Mixed Models Analysis|||||2.55|-0.93|<0.05
71775045|NCT00777205|143050272|SUPERIORITY_OR_OTHER||Slope|-0.039|||<|0.05|TWO_SIDED|95.0|-2.66|1.89|||Mixed Models Analysis|||||1.89|-2.66|<0.05
71825831|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62||||0.8599|TWO_SIDED|95.0|-6.28|7.51||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||7.51|-6.28|0.8599
71705450|NCT05103332|142929027|SUPERIORITY||Difference in LS Mean|-13.6|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|-16.9|-10.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to indapamide) and placebo (add on to indapamide), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-10.3|-16.9|<0.0001
71705451|NCT05103332|142929028|SUPERIORITY||Odds Ratio (OR)|12.39|||<|0.0001|TWO_SIDED|95.0|4.61|33.29||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||33.29|4.61|<0.0001
71705452|NCT05103332|142929039|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-13.4|-6.9||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-6.9|-13.4|<0.0001
71705453|NCT05103332|142929040|SUPERIORITY||Difference in LS Mean|-7.9|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-10.6|-5.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||-5.3|-10.6|<0.0001
71705454|NCT05103332|142929041|SUPERIORITY||Difference in LS Mean|-8.6|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-10.9|-6.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to amlodipine) and placebo (add on to amlodipine), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-6.3|-10.9|<0.0001
71705455|NCT05103332|142929042|SUPERIORITY||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.43|10.61||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||10.61|2.43|<0.0001
71705456|NCT05103332|142929053|SUPERIORITY||Difference in LS Mean|-6.7|STANDARD_ERROR_OF_MEAN|1.76|=|0.0002|TWO_SIDED|95.0|-10.2|-3.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in order the endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at nominal p-value \< 0.05. Data for office SBP assessed while participants were on and within 2 weeks after stopping any escape medication were censored for this endpoint.||-3.3|-10.2|=0.0002
71738955|NCT03637517|142990707|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.899||||0.1135|TWO_SIDED|90.0|0.805|1.004|||ANOVA|||||1.004|0.805|0.1135
71705457|NCT05103332|142929054|SUPERIORITY||Difference in LS Mean|-1.8|STANDARD_ERROR_OF_MEAN|1.42|=|0.2103|TWO_SIDED|95.0|-4.6|1.0||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for SBP assessed by ABPM, were included in the analysis for this endpoint.||1.0|-4.6|=0.2103
71705458|NCT05103332|142929055|SUPERIORITY||Difference in LS Mean|-4.5|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|-6.8|-2.3||MMRM model included treatment, visit, treatment-by-visit interaction, race (black or all other races) as fixed factors, with baseline office SBP and baseline eGFR as covariates. Unstructured covariance matrix was used.|MMRM||LS Mean Difference between zilebesiran (add on to olmesartan) and placebo (add on to olmesartan), 95% CI was calculated using MMRM model.|A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05. All collected data for office SBP were included in the analysis for this endpoint.||-2.3|-6.8|<0.0001
71705459|NCT05103332|142929056|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.123|TWO_SIDED|95.0|0.87|3.23||Logistic regression model included treatment and race (black or all other races) as factors and baseline 24-hour mean SBP and baseline eGFR as covariates.|Regression, Logistic|||A hierarchical testing procedure was used to control type I error at α=0.05 within each cohort and handle primary and key secondary endpoints analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at nominal p-value \< 0.05.||3.23|0.87|=0.1230
71705460|NCT01740427|142929073|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|1e-06|TWO_SIDED|95.0|0.463|0.718||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||0.718|0.463|<0.000001
71705461|NCT01740427|142929074|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.428||||0.0224|TWO_SIDED|95.0|1.008|2.03||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.030|1.008|0.0224
71705462|NCT01740427|142929075|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.594||||0.009|TWO_SIDED|95.0|1.08|2.347||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.||2.347|1.080|0.0090
71705463|NCT01740427|142929077|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.451|||<|0.0001|TWO_SIDED|95.0|1.619|3.722||1-sided p-value is from exact test.|Fisher Exact|||Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.||3.722|1.619|<0.0001
71705464|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.571|||<|0.0001|TWO_SIDED|95.0|0.443|0.737|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER positive||0.737|0.443|<0.0001
71705465|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.405||||0.003|TWO_SIDED|95.0|0.218|0.751|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER Negative||0.751|0.218|0.0030
71705466|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.531|||<|0.0001|TWO_SIDED|95.0|0.416|0.68|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Positive||0.680|0.416|<0.0001
71705467|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.675||||0.3237|TWO_SIDED|95.0|0.308|1.481|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Negative||1.481|0.308|0.3237
71705468|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.555|||<|0.0001|TWO_SIDED|95.0|0.437|0.705|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Positive||0.705|0.437|<0.0001
71705469|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.9964|TWO_SIDED|95.0|0.287|3.461|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Negative||3.461|0.287|0.9964
71705470|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.518|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Positive||0.670|0.400|<0.0001
71705471|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.731||||0.3221|TWO_SIDED|95.0|0.392|1.364|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Negative||1.364|0.392|0.3221
71705472|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.581|||<|0.0001|TWO_SIDED|95.0|0.455|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\<175||0.742|0.455|<0.0001
71705473|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.255||||0.0022|TWO_SIDED|95.0|0.1|0.65|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore\>=175||0.650|0.100|0.0022
71705474|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.379|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \<=20%||0.742|0.379|0.0002
71705475|NCT01740427|142929078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.569||||0.0007|TWO_SIDED|95.0|0.409|0.791|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 \>20%||0.791|0.409|0.0007
71705476|NCT01740427|142929082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.023||||0.0925|TWO_SIDED|95.0|-0.004|0.051|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||0.051|-0.004|0.0925
71705477|NCT01740427|142929083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.325||||0.7822|TWO_SIDED|95.0|-2.63|1.98|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||||1.98|-2.63|0.7822
71705478|NCT01740427|142929085|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.956||||0.33775|TWO_SIDED|95.0|0.777|1.177||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.177|0.777|0.337750
71763921|NCT05477108|143029581|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 74.17. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2735 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|102.02|||||TWO_SIDED|90.0|89.12|116.79|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (US approach)||116.79|89.12|
71763922|NCT05477108|143029581|EQUIVALENCE|For AUClast, the intra-participant CV% in Treatment B (reference arm) was 66.88. An analysis was conducted based on the RSABE method for a partial-replicate 3-way cross-over design. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since criteria bound was -0.2210 (\<0) and point estimate for geometric mean ratio was within 80% and 125%.|Geometric Mean Ratio (%)|107.76|||||TWO_SIDED|90.0|94.91|122.36|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (US approach)||122.36|94.91|
71763923|NCT05477108|143029581|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean ratio (%)|106.1|||||TWO_SIDED|90.0|98.39|114.41|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Budesonide Pharmacokinetic Parameters (EU approach)||114.41|98.39|
71763924|NCT05477108|143029581|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|97.02|||||TWO_SIDED|90.0|84.18|111.82|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Glycopyrronium Pharmacokinetic Parameters (EU approach)||111.82|84.18|
71763925|NCT05477108|143029581|EQUIVALENCE|For AUClast, the analysis was conducted using an analysis of variance including fixed effects for treatment, sequence, period and subject within sequence. The PK parameter was log-transformed prior to analysis. Bioequivalence was concluded since the 90% CI for the geometric mean ratio were fully contained within the predefined equivalence limits of 80% to 125%.|Geometric Mean Ratio (%)|105.74|||||TWO_SIDED|90.0|92.59|120.75|||||Geometric mean ratio is calculated as A/B.|Statistical Comparison of Key Formoterol Pharmacokinetic Parameters (EU approach)||120.75|92.59|
71705479|NCT01740427|142929086|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.921||||0.208706|TWO_SIDED|95.0|0.755|1.124||1-sided p-value from the stratified log-rank test.|Stratified Log Rank|||||1.124|0.755|0.208706
71705480|NCT04906421|142929089|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population analysis||||0.0018
71763926|NCT02660983|143029589|SUPERIORITY||Difference in least square (LS) means|-0.58||||0.3455|TWO_SIDED|95.0|-1.79|0.63|||ANCOVA|||||0.63|-1.79|0.3455
71763927|NCT02660983|143029590|SUPERIORITY||Difference in LS means|-0.12||||0.257|TWO_SIDED|95.0|-0.32|0.09|||ANCOVA||LS mean of Donepezil group - LS mean of Placebo (when the difference of LS mean scores were less than 0, considered as demonstrated hypothesis), analyzed with ANCOVA model with baseline (CIBIS) as covariate and treatment as main effect.|||0.09|-0.32|0.2570
71705481|NCT04906421|142929089|SUPERIORITY|||||||0.0035||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0035
71705482|NCT04906421|142929089|SUPERIORITY|||||||0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|t-test, 1 sided|One-sided||mITT Population Analysis||||0.0001
71705483|NCT04906421|142929089|SUPERIORITY|||||||0.0003||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0003
71763928|NCT02660983|143029591|SUPERIORITY||Difference in LS means|0.65||||0.0396|TWO_SIDED|95.0|0.03|1.26|||ANCOVA|||||1.26|0.03|0.0396
71705484|NCT04906421|142929090|SUPERIORITY|||||||0.0087||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||ITT Population Analysis||||0.0087
71705485|NCT04906421|142929090|SUPERIORITY|||||||0.0173||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||ITT Population Analysis||||0.0173
71705486|NCT04906421|142929090|SUPERIORITY|||||||0.0022||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|One-sided||mITT Population Analysis||||0.0022
71705487|NCT04906421|142929090|SUPERIORITY|||||||0.0044||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0044
71705488|NCT04906421|142929091|SUPERIORITY|||||||0.0102|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0102
71705489|NCT04906421|142929091|SUPERIORITY|||||||0.59|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Fibrosis Stage F2 at Baseline Population Analysis||||0.59
71763929|NCT02660983|143029592|SUPERIORITY||Difference in LS means|-7.73||||0.2213|TWO_SIDED|95.0|-20.13|4.68|||ANCOVA|||Part A||4.68|-20.13|0.2213
71763930|NCT02660983|143029592|SUPERIORITY||Difference in LS means|-14.88||||0.0551|TWO_SIDED|95.0|-30.1|0.33|||ANCOVA|||Part B||0.33|-30.10|0.0551
71763931|NCT03376295|143029597|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.2|||Cox proportional hazards model||The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.20|0.90|
71763932|NCT03376295|143029597|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.65|1.36|||Cox proportional hazards model||HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.36|0.65|
71763933|NCT03376295|143029598|OTHER||Rate ratio (RR)|1.07|||||TWO_SIDED|95.0|0.92|1.25|||Negative binomial model||The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Moderate/severe exacerbation||1.25|0.92|
71763934|NCT03376295|143029598|OTHER||Rate ratio (RR)|0.85|||||TWO_SIDED|95.0|0.55|1.33|||Negative binomial model||The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Severe exacerbation||1.33|0.55|
71763935|NCT03376295|143029599|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.42|1.05|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||1.05|0.42|
71763936|NCT03376295|143029599|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.48|0.92|||Cox proportional hazards model||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.||0.92|0.48|
71763937|NCT00893815|143029600|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.1||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|||1.10|0.27|0.09
71705490|NCT04906421|142929091|SUPERIORITY|||||||0.0032|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-Sided||Subgroup Fibrosis Stage F3 at Baseline Population Analysis||||0.0032
71763938|NCT00893815|143029601|OTHER||Odds Ratio (OR)|0.75||||0.45|TWO_SIDED|95.0|0.35|1.61||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of verbal fluency impairment between HIV-positive and HIV-negative military beneficiaries||1.61|0.35|0.45
71705491|NCT04906421|142929091|SUPERIORITY|||||||0.0764|TWO_SIDED|95.0||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||Subgroup Type 2 Diabetes Mellitus at Baseline Population Analysis||||0.0764
71763939|NCT00893815|143029601|OTHER||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.35|1.56||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of abstraction executive functioning impairment between HIV-positive and HIV-negative military beneficiaries||1.56|0.35|0.43
71763940|NCT00893815|143029601|OTHER||Odds Ratio (OR)|1.45||||0.56|TWO_SIDED|95.0|0.41|5.17||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of speed of information processing impairment between HIV-positive and HIV-negative military beneficiaries||5.17|0.41|0.56
71763941|NCT00893815|143029601|OTHER||Odds Ratio (OR)|1.32||||0.49|TWO_SIDED|95.0|0.6|2.93||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of attention/working memory impairment between HIV-positive and HIV-negative military beneficiaries||2.93|0.60|0.49
71763942|NCT00893815|143029601|OTHER||Odds Ratio (OR)|0.43||||0.01|TWO_SIDED|95.0|0.22|0.84||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of learning impairment between HIV-positive and HIV-negative military beneficiaries||0.84|0.22|0.01
71775046|NCT00777205|143050273|SUPERIORITY_OR_OTHER||Slope|-0.08|||||TWO_SIDED|95.0|-3.31|3.16||||||||3.16|-3.31|
71775047|NCT03053271|143050297|OTHER|No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||||||||||||||||No statistical test was done as only 4 subjects could be enrolled, none met criteria for randomization, and the study was discontinued by the Sponsor.|||
71705492|NCT04906421|142929092|SUPERIORITY|||||||0.0043||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0043
71705493|NCT04906421|142929093|SUPERIORITY|||||||0.0018||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||0.0018
71705494|NCT04906421|142929094|SUPERIORITY||||||<|0.0001||||||Stratified CMH test stratified by T2DM status at baseline (yes or no) and amount of fibrosis at baseline (F2 or F3).|Cochran-Mantel-Haenszel|Two-sided||mITT Population Analysis||||<0.0001
71705495|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.77|||||TWO_SIDED|95.0|1.3|2.4||||||1 min post bolus (Bolus time: 3 hours)||2.40|1.30|
71705496|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.91|||||TWO_SIDED|95.0|1.42|2.59||||||1 min post bolus (Bolus time: 3 hours)||2.59|1.42|
71705497|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.37|2.49||||||1 min post bolus (Bolus time: 3 hours)||2.49|1.37|
71705498|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.42|||||TWO_SIDED|95.0|1.05|1.92||||||1 min post bolus (Bolus time: 3 hours)||1.92|1.05|
71705499|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.08|||||TWO_SIDED|95.0|0.8|1.46||||||1 min post bolus (Bolus time: 3 hours)||1.46|0.80|
71705500|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||1 min post bolus (Bolus time: 3 hours)||1.41|0.77|
71705501|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.08||||||1 min post bolus (Bolus time: 3 hours)||1.08|0.59|
71705502|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.96|||||TWO_SIDED|95.0|0.72|1.3||||||1 min post bolus (Bolus time: 3 hours)||1.30|0.72|
71705503|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||1 min post bolus (Bolus time: 3 hours)||1.00|0.55|
71705504|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.77|||||TWO_SIDED|95.0|0.57|1.04||||||1 min post bolus (Bolus time: 3 hours)||1.04|0.57|
71705505|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.09|2.02||||||1 min post bolus (Bolus time: 6 hours)||2.02|1.09|
71705506|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.68|||||TWO_SIDED|95.0|1.25|2.28||||||1 min post bolus (Bolus time: 6 hours)||2.28|1.25|
71705507|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.84|||||TWO_SIDED|95.0|1.36|2.48||||||1 min post bolus (Bolus time: 6 hours)||2.48|1.36|
71705508|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.16|||||TWO_SIDED|95.0|0.85|1.56||||||1 min post bolus (Bolus time: 6 hours)||1.56|0.85|
71705509|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.13|||||TWO_SIDED|95.0|0.83|1.54||||||1 min post bolus (Bolus time: 6 hours)||1.54|0.83|
71705510|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.24|||||TWO_SIDED|95.0|0.91|1.68||||||1 min post bolus (Bolus time: 6 hours)||1.68|0.91|
71705511|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.05||||||1 min post bolus (Bolus time: 6 hours)||1.05|0.57|
71705512|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.09|||||TWO_SIDED|95.0|0.81|1.47||||||1 min post bolus (Bolus time: 6 hours)||1.47|0.81|
71705513|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.69|||||TWO_SIDED|95.0|0.51|0.93||||||1 min post bolus (Bolus time: 6 hours)||0.93|0.51|
71705514|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.85||||||1 min post bolus (Bolus time: 6 hours)||0.85|0.47|
71705515|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.03||||||1 min post bolus (Bolus time: 9 hours)||2.03|1.10|
71705516|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.96|||||TWO_SIDED|95.0|1.45|2.65||||||1 min post bolus (Bolus time: 9 hours)||2.65|1.45|
71705517|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|2.03|||||TWO_SIDED|95.0|1.5|2.74||||||1 min post bolus (Bolus time: 9 hours)||2.74|1.50|
71705518|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||1 min post bolus (Bolus time: 9 hours)||1.69|0.93|
71705519|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.31|||||TWO_SIDED|95.0|0.97|1.78||||||1 min post bolus (Bolus time: 9 hours)||1.78|0.97|
71705520|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.36|||||TWO_SIDED|95.0|1.01|1.84||||||1 min post bolus (Bolus time: 9 hours)||1.84|1.01|
71705521|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.84|||||TWO_SIDED|95.0|0.62|1.14||||||1 min post bolus (Bolus time: 9 hours)||1.14|0.62|
71705522|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.77|1.4||||||1 min post bolus (Bolus time: 9 hours)||1.40|0.77|
71705523|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||1 min post bolus (Bolus time: 9 hours)||0.86|0.47|
71705524|NCT05067270|142929107|OTHER||Geometric Least Squares Mean Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.83||||||1 min post bolus (Bolus time: 9 hours)||0.83|0.46|
71705525|NCT02186171|142929116|SUPERIORITY||LS Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|9.6|12.2||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||12.2|9.6|< 0.0001
71705526|NCT02186171|142929117|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.3|3.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.7|2.3|< 0.0001
71705527|NCT02186171|142929118|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.5|3.3||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||3.3|1.5|< 0.0001
71705528|NCT02186171|142929119|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|7.6|9.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||9.7|7.6|< 0.0001
71705529|NCT02186171|142929120|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|0.8|2.0||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.0|0.8|< 0.0001
71825832|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-34.2|-20.3||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.30|-34.20|<0.0001
71763943|NCT00893815|143029601|OTHER||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.34||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of recall impairment between HIV-positive and HIV-negative military beneficiaries||3.34|0.58|0.46
71705530|NCT02186171|142929121|SUPERIORITY|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.4|=|0.0033|TWO_SIDED|95.0|0.4|2.1||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA|||||2.1|0.4|= 0.0033
71705531|NCT06765889|142929122|OTHER||Bayes Factor (BF₁₀)|0.03|||||TWO_SIDED|||||||||||||
71705532|NCT06765889|142929125|OTHER||Mean (of both conditions)|4.17|||||TWO_SIDED|||||||||||||
71705533|NCT05675020|142929155|OTHER|The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0. We analyzed the percentage of correct responses for knowledge survey questions from pre- and post-intervention survey responses.|||||||||||||||||Participant data was collected from the REDCap pre- and post-intervention questionnaires completed by the adolescents and parents/legal guardians that participated in the project. Data was collected from October to December 2022. The sample size was nine parent-adolescent dyads. Descriptive analysis was used to assess differences in sociodemographic variables, including age, gender, race, material status, employment status, salary, height, and weight. The descriptive analysis yields frequencies and percentages for categorical variables. The statistical analysis was conducted using IBM SPSS V27.0.|||
71705534|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|115.78|||||TWO_SIDED|90.0|107.04|125.22|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.22|107.04|
71705535|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Astellas Ratio|103.7|||||TWO_SIDED|90.0|95.91|112.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.12|95.91|
71705536|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|99.79|||||TWO_SIDED|90.0|92.3|107.89|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.89|92.30|
71705537|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio|103.65|||||TWO_SIDED|90.0|95.83|112.11|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and Cmax parameters||112.11|95.83|
71705538|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X100|101.7|||||TWO_SIDED|90.0|94.03|110.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 and parameters||110.0|94.03|
71705539|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddys Ratio X 100|111.64|||||TWO_SIDED|90.0|103.26|120.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.70|103.26|
71705540|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|116.02|||||TWO_SIDED|90.0|107.27|125.49|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||125.49|107.27|
71705541|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|111.7|||||TWO_SIDED|90.0|103.27|120.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.81|103.27|
71705542|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|113.84|||||TWO_SIDED|90.0|105.3|123.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||123.08|105.30|
71705543|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ratio X 100|103.92|||||TWO_SIDED|90.0|96.08|112.4|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.40|96.08|
71763944|NCT00893815|143029601|OTHER||Odds Ratio (OR)|0.89||||0.76|TWO_SIDED|95.0|0.43|1.85||Threshold for statistical significance: 0.05|Regression, Logistic||HIV-positive / HIV-negative|Comparing prevalence of motor speed \& dexterity impairment between HIV-positive and HIV-negative military beneficiaries||1.85|0.43|0.76
71886543|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.13|=|0.6999|TWO_SIDED|95.0|-5.0|3.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||3.4|-5.0|=0.6999
71763945|NCT04303195|143029612|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.479||0.135|TWO_SIDED|95.0|-1.67|0.23||The threshold for statistical significance was p = 0.05.|ANOVA|||||0.23|-1.67|0.1350
71763946|NCT04303195|143029612|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.493||0.0997|TWO_SIDED|95.0|-1.79|0.16||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.16|-1.79|0.0997
71763947|NCT04303195|143029612|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.492||0.2195|TWO_SIDED|95.0|-1.58|0.37||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.37|-1.58|0.2195
71763948|NCT04303195|143029613|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.498||0.7944|TWO_SIDED|95.0|-1.11|0.85||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.85|-1.11|0.7944
71763949|NCT04303195|143029613|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.51||0.4956|TWO_SIDED|95.0|-1.36|0.66||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.66|-1.36|0.4956
71763950|NCT04303195|143029613|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.511||0.626|TWO_SIDED|95.0|-0.76|1.26||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.26|-0.76|0.6260
71763951|NCT04303195|143029614|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.543||0.8866|TWO_SIDED|95.0|-1.15|1.0||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.00|-1.15|0.8866
71763952|NCT04303195|143029614|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.558||0.8699|TWO_SIDED|95.0|-1.19|1.01||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.01|-1.19|0.8699
71763953|NCT04303195|143029614|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.556||0.7297|TWO_SIDED|95.0|-0.91|1.29||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.29|-0.91|0.7297
71763954|NCT04303195|143029615|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.409||0.9034|TWO_SIDED|95.0|-0.76|0.86||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.86|-0.76|0.9034
71763955|NCT04303195|143029615|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9742|TWO_SIDED|95.0|-0.68|0.63||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.63|-0.68|0.9742
71763956|NCT04303195|143029615|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.417||0.2235|TWO_SIDED|95.0|-0.31|1.33||The threshold for statistical significance was p = 0.05.|ANCOVA|||||1.33|-0.31|0.2235
71763957|NCT04303195|143029616|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3567|TWO_SIDED|95.0|-0.34|0.12||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.12|-0.34|0.3567
71825833|NCT00708097|143156289|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.87|||<|0.0001|TWO_SIDED|95.0|-34.84|-20.89||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||-20.89|-34.84|<0.0001
71763958|NCT04303195|143029616|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1129|TWO_SIDED|95.0|-0.43|0.05||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.05|-0.43|0.1129
71763959|NCT04303195|143029616|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.459|TWO_SIDED|95.0|-0.33|0.15||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.15|-0.33|0.4590
71763960|NCT04303195|143029617|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.485||0.525|TWO_SIDED|95.0|-1.27|0.65||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.65|-1.27|0.5250
71763961|NCT04303195|143029617|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.498||0.3991|TWO_SIDED|95.0|-1.41|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.41|0.3991
71763962|NCT04303195|143029617|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.497||0.9006|TWO_SIDED|95.0|-1.05|0.92||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.92|-1.05|0.9006
71763963|NCT04303195|143029618|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.444||0.6009|TWO_SIDED|95.0|-1.11|0.64||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.64|-1.11|0.6009
71763964|NCT04303195|143029618|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.454||0.4654|TWO_SIDED|95.0|-1.23|0.56||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.56|-1.23|0.4654
71763965|NCT04303195|143029618|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.455||0.8842|TWO_SIDED|95.0|-0.83|0.97||The threshold for statistical significance was p = 0.05.|ANCOVA|||||0.97|-0.83|0.8842
71763966|NCT06457204|143029619|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.4|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 6.9."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.4|
71763967|NCT06457204|143029620|OTHER||Ratio of adjusted geometric means [%]|98.3|||||TWO_SIDED|90.0|91.6|105.5|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 15.0."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.5|91.6|
71825834|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.45||||0.5451|TWO_SIDED|95.0|-6.15|3.26||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||3.26|-6.15|0.5451
71825835|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.5||||0.1433|TWO_SIDED|95.0|-1.2|8.19||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.19|-1.20|0.1433
71825836|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.47||||0.002|TWO_SIDED|95.0|2.78|12.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||12.16|2.78|0.0020
71825837|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.52|||<|0.0001|TWO_SIDED|95.0|18.79|28.25||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||28.25|18.79|<0.0001
71825838|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.94||||0.0373|TWO_SIDED|95.0|0.29|9.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||9.59|0.29|0.0373
71825839|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.92||||0.0002|TWO_SIDED|95.0|4.24|13.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||13.59|4.24|0.0002
71825840|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|24.97|||<|0.0001|TWO_SIDED|95.0|20.27|29.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||29.66|20.27|<0.0001
71825841|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.98||||0.0925|TWO_SIDED|95.0|-0.66|8.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||8.61|-0.66|0.0925
71825842|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.03|||<|0.0001|TWO_SIDED|95.0|15.35|24.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||24.70|15.35|<0.0001
71825843|NCT00708097|143156290|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.05|||<|0.0001|TWO_SIDED|95.0|11.36|20.74||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.||20.74|11.36|<0.0001
71705544|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio x 100|100.05|||||TWO_SIDED|90.0|92.5|108.21|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||108.21|92.50|
71705545|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|101.97|||||TWO_SIDED|90.0|94.28|110.29|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.29|94.28|
71705546|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|96.28|||||TWO_SIDED|90.0|89.05|104.09|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.09|89.05|
71705547|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|98.12|||||TWO_SIDED|90.0|90.72|106.12|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||106.12|90.72|
71705548|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|101.92|||||TWO_SIDED|90.0|94.27|110.19|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||110.19|94.27|
71705549|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|109.75|||||TWO_SIDED|90.0|100.42|119.25|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||119.25|100.42|
71705550|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|99.76|||||TWO_SIDED|90.0|91.28|109.03|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||109.03|91.28|
71886544|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24|=|0.1765|TWO_SIDED|95.0|-7.5|1.4|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||1.4|-7.5|=0.1765
71705551|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|101.63|||||TWO_SIDED|90.0|92.99|111.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.06|92.99|
71705552|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|106.2|||||TWO_SIDED|90.0|97.17|116.06|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||116.06|97.17|
71705553|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|104.09|||||TWO_SIDED|90.0|95.25|113.75|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||113.75|95.25|
71705554|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|110.02|||||TWO_SIDED|90.0|100.66|120.24|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||120.24|100.66|
71705555|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|108.0|||||TWO_SIDED|90.0|98.82|118.02|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||118.02|98.82|
71763968|NCT06457204|143029621|OTHER||Ratio of adjusted geometric means [%]|101.6|||||TWO_SIDED|90.0|98.2|105.0|||||"Ratio of adjusted geometric means \[%\] calculated as: test/reference\*100.~Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.1."|Analysis of variance (ANOVA) on the logarithmic scale included effects for sequence, subjects nested within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed. confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t-distribution. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs.||105.0|98.2|
71705556|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|103.34|||||TWO_SIDED|90.0|94.56|112.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||112.94|94.56|
71705557|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|105.44|||||TWO_SIDED|90.0|96.48|115.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||115.23|96.48|
71705558|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan Ration X 100|98.16|||||TWO_SIDED|90.0|89.82|107.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.28|89.82|
71705559|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|93.93|||||TWO_SIDED|90.0|85.96|102.65|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||102.65|85.96|
71705560|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|95.84|||||TWO_SIDED|90.0|87.69|104.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.74|87.69|
71763969|NCT01065454|143029622|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.71||||0.1044|TWO_SIDED|95.0|-5.99|0.057||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||0.057|-5.99|0.1044
71825844|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01||||0.9697|TWO_SIDED|95.0|-106.34|102.32||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||102.32|-106.34|0.9697
71825845|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|106.9||||0.044|TWO_SIDED|95.0|2.92|210.87||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||210.87|2.92|0.0440
71825846|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.92||||0.0026|TWO_SIDED|95.0|56.96|264.88||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||264.88|56.96|0.0026
71653500|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.04|-0.4|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.04|<.0001
71705561|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|95.69|||||TWO_SIDED|90.0|87.56|104.58|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||104.58|87.56|
71705562|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|97.63|||||TWO_SIDED|90.0|89.34|107.71|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||107.71|89.34|
71705563|NCT02014103|142929158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Pancea/Sandoz Ratio X 100|102.03|||||TWO_SIDED|90.0|93.36|111.51|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed AUC 0-12 parameters||111.51|93.36|
71705564|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|141.91|||||TWO_SIDED|90.0|125.73|160.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||160.16|125.73|
71705565|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|104.13|||||TWO_SIDED|90.0|92.33|117.45|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||117.45|92.33|
71705566|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astellas Ratio X 100|116.02|||||TWO_SIDED|90.0|102.87|130.87|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.87|102.87|
71705567|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|108.92|||||TWO_SIDED|90.0|96.51|122.94|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||122.94|96.51|
71705568|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|94.06|||||TWO_SIDED|90.0|83.33|106.16|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||106.16|83.33|
71705569|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr. Reddys Ratio X 100|136.27|||||TWO_SIDED|90.0|120.82|153.7|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||153.70|120.82|
71705570|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|122.31|||||TWO_SIDED|90.0|108.37|138.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||138.04|108.37|
71705571|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|130.28|||||TWO_SIDED|90.0|115.43|147.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||147.04|115.43|
71705572|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|150.88|||||TWO_SIDED|90.0|133.77|170.18|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||170.18|133.77|
71763970|NCT01065454|143029622|SUPERIORITY_OR_OTHER_LEGACY||LSMEANS Difference|-1.38||||0.5292|TWO_SIDED|95.0|-5.71|2.94||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||2.94|-5.71|0.5292
71825847|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|222.47|||<|0.0001|TWO_SIDED|95.0|117.58|327.36||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||327.36|117.58|<0.0001
71653501|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
71653502|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.44|-1.14|<.0001
71653503|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18||0.0006|TWO_SIDED|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.98|0.0006
71653504|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.25|-0.96|0.0009
71653505|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0377|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.02|-0.78|0.0377
71653506|NCT02709486|142824946|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|-0.96|-0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.96|0.0019
71653507|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.39|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-0.99|<.0001
71653508|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0002|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.27|-0.87|0.0002
71653509|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.29|<.0001
71653510|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.28|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.65|-1.28|<.0001
71763971|NCT01065454|143029622|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.51||||0.0278|TWO_SIDED|95.0|-8.52|-0.5||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||-0.50|-8.52|0.0278
71763972|NCT01065454|143029622|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.8||||0.3821|TWO_SIDED|95.0|-2.25|5.84||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||5.84|-2.25|0.3821
71763973|NCT01065454|143029622|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|3.13||||0.2084|TWO_SIDED|95.0|-1.76|8.02||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||8.02|-1.76|0.2084
71825848|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|108.91||||0.0382|TWO_SIDED|95.0|5.98|211.83||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||211.83|5.98|0.0382
71825849|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|162.93||||0.0021|TWO_SIDED|95.0|59.68|266.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||266.18|59.68|0.0021
71825850|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|224.48|||<|0.0001|TWO_SIDED|95.0|120.51|328.46||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||328.46|120.51|<0.0001
71825851|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|54.03||||0.3003|TWO_SIDED|95.0|-48.56|156.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||156.61|-48.56|0.3003
71825852|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.55||||0.2432|TWO_SIDED|95.0|-42.14|165.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||165.24|-42.14|0.2432
71653511|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.11|<.0001
71653512|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.35|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.67|-1.35|<.0001
71653513|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.11|<.0001
71653514|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.23|<.0001
71653515|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.19||0.0005|TWO_SIDED|95.0|-1.03|-0.29|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.03|0.0005
71653516|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.13|<.0001
71653517|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.2||0.0246|TWO_SIDED|95.0|-0.82|-0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.82|0.0246
71705573|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Mylan Ratio X 100|89.75|||||TWO_SIDED|90.0|79.52|101.3|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||101.30|79.52|
71705574|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Panacea Ratio X 100|95.6|||||TWO_SIDED|90.0|84.71|107.9|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.90|84.71|
71705575|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Sandoz Ratio X 100|110.72|||||TWO_SIDED|90.0|98.1|124.96|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||124.96|98.10|
71705576|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|106.52|||||TWO_SIDED|90.0|94.44|120.15|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||120.15|94.44|
71705577|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|123.36|||||TWO_SIDED|90.0|109.3|139.23|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||139.23|109.30|
71705578|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|115.81|||||TWO_SIDED|90.0|102.68|130.62|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||130.62|102.68|
71705579|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Astellas Ratio X 100|112.96|||||TWO_SIDED|90.0|100.32|127.2|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.20|100.32|
71705580|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Astellas Ratio X 100|101.75|||||TWO_SIDED|90.0|90.37|114.57|||||Bioequivalence is established when 90% confidence interval falls within 80-125|||114.57|90.37|
71705581|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Astella Ratio X 100|113.52|||||TWO_SIDED|90.0|100.82|127.83|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||127.83|100.82|
71705582|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Astellas Ratio X 100|99.16|||||TWO_SIDED|90.0|88.06|111.64|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||111.64|88.06|
71705583|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Sandoz/Astellas Ratio X 100|95.57|||||TWO_SIDED|90.0|84.89|107.61|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||107.61|84.89|
71705584|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Dr Reddy Ratio X 100|111.01|||||TWO_SIDED|90.0|98.59|125.0|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||125.00|98.59|
71763974|NCT01065454|143029622|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.33||||0.5442|TWO_SIDED|95.0|-5.66|3.0||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA|||||3.00|-5.66|0.5442
71705585|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Mylan Ratio X 100|99.51|||||TWO_SIDED|90.0|88.38|112.04|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||112.04|88.38|
71705586|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Panacea Ratio X 100|113.93|||||TWO_SIDED|90.0|101.18|128.28|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.28|101.18|
71705587|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Accord/Sandoz Ratio X 100|118.19|||||TWO_SIDED|90.0|104.96|133.08|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.08|104.96|
71705588|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr Reddys/Mylan|89.64|||||TWO_SIDED|90.0|79.61|100.93|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||100.93|79.61|
71705589|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Panacea Ratio X 100|102.63|||||TWO_SIDED|90.0|91.15|115.55|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||115.55|91.15|
71763975|NCT01065454|143029623|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|1.87|||||TWO_SIDED|95.0|-0.83|4.56||||||||4.56|-0.83|
71763976|NCT01065454|143029623|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-3.12|3.51||||||||3.51|-3.12|
71763977|NCT01065454|143029623|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.23|||||TWO_SIDED|95.0|-3.31|3.77||||||||3.77|-3.31|
71763978|NCT01065454|143029624|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-46.59|||||TWO_SIDED|95.0|-89.4|-3.8||||||||-3.8|-89.4|
71763979|NCT01065454|143029624|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-32.26|||||TWO_SIDED|95.0|-84.9|20.4||||||||20.4|-84.9|
71653518|NCT02709486|142824948|SUPERIORITY||Least Square Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.2||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.10|0.0003
71653519|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.57||0.6427|TWO_SIDED|95.0|-3.9|6.29|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.29|-3.90|0.6427
71653520|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|2.59||0.4208|TWO_SIDED|95.0|-7.22|3.04|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.04|-7.22|0.4208
71653521|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.73||0.8204|TWO_SIDED|95.0|-6.03|4.79|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.79|-6.03|0.8204
71653522|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-4.52|STANDARD_ERROR_OF_MEAN|2.85||0.1157|TWO_SIDED|95.0|-10.16|1.13|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.13|-10.16|0.1157
71653523|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|2.41||0.5845|TWO_SIDED|95.0|-6.12|3.47|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.47|-6.12|0.5845
71653524|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.54||0.2514|TWO_SIDED|95.0|-7.97|2.11|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.11|-7.97|0.2514
71653525|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-6.68|STANDARD_ERROR_OF_MEAN|3.67||0.0717|TWO_SIDED|95.0|-13.97|0.6|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-13.97|0.0717
71653526|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-12.69|STANDARD_ERROR_OF_MEAN|3.74||0.001|TWO_SIDED|95.0|-20.11|-5.26|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-5.26|-20.11|0.0010
71653527|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|3.8||0.0079|TWO_SIDED|95.0|-17.85|-2.77|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.77|-17.85|0.0079
71653528|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-10.56|STANDARD_ERROR_OF_MEAN|4.0||0.0096|TWO_SIDED|95.0|-18.49|-2.63|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.63|-18.49|0.0096
71653529|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-4.28|STANDARD_ERROR_OF_MEAN|4.37||0.3302|TWO_SIDED|95.0|-12.97|4.41|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.41|-12.97|0.3302
71653530|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-2.74|STANDARD_ERROR_OF_MEAN|4.54||0.5483|TWO_SIDED|95.0|-11.78|6.3|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||6.30|-11.78|0.5483
71653531|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|3.79||0.0774|TWO_SIDED|95.0|-14.26|0.76|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.76|-14.26|0.0774
71653532|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-12.48|STANDARD_ERROR_OF_MEAN|3.87||0.0017|TWO_SIDED|95.0|-20.15|-4.81|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-4.81|-20.15|0.0017
71705590|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Dr. Reddys/Sandoz Ratio X 100|106.46|||||TWO_SIDED|90.0|94.55|119.88|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||119.88|94.55|
71763980|NCT01065454|143029624|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-26.52|||||TWO_SIDED|95.0|-83.0|30.0||||||||30.0|-83.0|
71763981|NCT01065454|143029625|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-89.17|||||TWO_SIDED|95.0|-172.9|5.5||||||||5.5|-172.9|
71763982|NCT01065454|143029625|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-58.22|||||TWO_SIDED|95.0|-162.1|45.6||||||||45.6|-162.1|
71763983|NCT01065454|143029625|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-43.22|||||TWO_SIDED|95.0|-153.7|67.1||||||||67.1|-153.7|
71763984|NCT01065454|143029626|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-239.31|||||TWO_SIDED|95.0|-363.4|-115.3||||||||-115.3|-363.4|
71763985|NCT01065454|143029626|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-120.89|||||TWO_SIDED|95.0|-274.4|32.6||||||||32.6|-274.4|
71763986|NCT01065454|143029626|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-25.54|||||TWO_SIDED|95.0|-189.3|138.2||||||||138.2|-189.3|
71825853|NCT00708097|143156291|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|115.58||||0.0289|TWO_SIDED|95.0|12.02|219.13||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||219.13|12.02|0.0289
71653533|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-9.41|STANDARD_ERROR_OF_MEAN|3.74||0.0135|TWO_SIDED|95.0|-16.83|-1.99|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-1.99|-16.83|0.0135
71653534|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-10.04|STANDARD_ERROR_OF_MEAN|3.97||0.0129|TWO_SIDED|95.0|-17.91|-2.17|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.17|-17.91|0.0129
71763987|NCT01065454|143029627|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-446.49|||||TWO_SIDED|95.0|-687.4|-205.6||||||||-205.6|-687.4|
71763988|NCT01065454|143029627|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-231.57|||||TWO_SIDED|95.0|-530.4|67.2||||||||67.2|-530.4|
71763989|NCT01065454|143029627|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-34.97|||||TWO_SIDED|95.0|-353.7|283.7||||||||283.7|-353.7|
71763990|NCT01065454|143029628|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-1.27|||||TWO_SIDED|95.0|-3.1|0.5||||||||0.5|-3.1|
71763991|NCT01065454|143029628|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.88|||||TWO_SIDED|95.0|-3.1|1.3||||||||1.3|-3.1|
71763992|NCT01065454|143029628|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.84|||||TWO_SIDED|95.0|-3.2|1.5||||||||1.5|-3.2|
71763993|NCT01065454|143029629|SUPERIORITY_OR_OTHER_LEGACY||LSS-MEANS Difference|-2.07|||||TWO_SIDED|95.0|-5.0|0.8||||||||0.8|-5.0|
71763994|NCT01065454|143029629|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS|1.39|||||TWO_SIDED|95.0|-2.1|4.9||||||||4.9|-2.1|
71763995|NCT01065454|143029629|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-1.13|||||TWO_SIDED|95.0|-4.9|2.7||||||||2.7|-4.9|
71763996|NCT01065454|143029630|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-0.58|1.14||||||||1.14|-0.58|
71763997|NCT01065454|143029630|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.82|||||TWO_SIDED|95.0|-0.23|1.87||||||||1.87|-0.23|
71763998|NCT01065454|143029630|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.03|||||TWO_SIDED|95.0|-1.11|1.06||||||||1.06|-1.11|
71763999|NCT01065454|143029631|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-3.84|||||TWO_SIDED|95.0|-8.76|1.09||||||||1.09|-8.76|
71764000|NCT01065454|143029631|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANs Difference|-0.02|||||TWO_SIDED|95.0|-6.05|6.01||||||||6.01|-6.05|
71764001|NCT01065454|143029631|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-2.43|||||TWO_SIDED|95.0|-8.93|4.06||||||||4.06|-8.93|
71764002|NCT01065454|143029632|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.51|||||TWO_SIDED|95.0|-0.21|1.24||||||||1.24|-0.21|
71764003|NCT01065454|143029632|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|0.81|||||TWO_SIDED|95.0|-0.07|1.69||||||||1.69|-0.07|
71764004|NCT01065454|143029632|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.2|||||TWO_SIDED|95.0|-0.74|1.15||||||||1.15|-0.74|
71764005|NCT01065454|143029633|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.06|||||TWO_SIDED|95.0|-17.33|7.22||||||||7.22|-17.33|
71764006|NCT01065454|143029633|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.28|||||TWO_SIDED|95.0|-14.55|15.11||||||||15.11|-14.55|
71764007|NCT01065454|143029633|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-5.18|||||TWO_SIDED|95.0|-21.05|10.69||||||||10.69|-21.05|
71764008|NCT01065454|143029634|SUPERIORITY_OR_OTHER_LEGACY||LS_MEANS Difference|-4.27|||||TWO_SIDED|95.0|-21.13|12.6||||||||12.60|-21.13|
71764009|NCT01065454|143029634|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|2.78|||||TWO_SIDED|95.0|-17.59|23.16||||||||23.16|-17.59|
71764010|NCT01065454|143029634|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-4.61|||||TWO_SIDED|95.0|-26.43|17.2||||||||17.20|-26.43|
71764011|NCT01065454|143029635|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|5.29|||||TWO_SIDED|95.0|-7.38|17.95||||||||17.95|-7.38|
71764012|NCT01065454|143029635|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|6.47|||||TWO_SIDED|95.0|-9.79|22.73||||||||22.73|-9.79|
71764013|NCT01065454|143029635|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.35|||||TWO_SIDED|95.0|-6.14|26.84||||||||26.84|-6.14|
71764014|NCT01065454|143029636|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.15|||||TWO_SIDED|95.0|-0.55|0.24||||||||0.24|-0.55|
71764015|NCT01065454|143029636|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.17|||||TWO_SIDED|95.0|-0.34|0.67||||||||0.67|-0.34|
71764016|NCT01065454|143029636|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.06|||||TWO_SIDED|95.0|-0.45|0.56||||||||0.56|-0.45|
71764017|NCT01065454|143029637|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|10.17|||||TWO_SIDED|95.0|-18.48|38.81||||||||38.81|-18.48|
71764018|NCT01065454|143029637|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|7.92|||||TWO_SIDED|95.0|-26.76|42.59||||||||42.59|-26.76|
71764019|NCT01065454|143029637|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.15|||||TWO_SIDED|95.0|-44.08|31.78||||||||31.78|-44.08|
71764020|NCT01065454|143029639|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.62|||||TWO_SIDED|95.0|-13.36|14.61||||||||14.61|-13.36|
71764021|NCT01065454|143029639|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.46|||||TWO_SIDED|95.0|-24.32|5.39||||||||5.39|-24.32|
71653535|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.43||0.3869|TWO_SIDED|95.0|-12.66|4.96|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||4.96|-12.66|0.3869
71653536|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|4.62||0.6485|TWO_SIDED|95.0|-11.31|7.08|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||7.08|-11.31|0.6485
71653537|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|1.61||0.0001|TWO_SIDED|95.0|-9.34|-3.03|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.03|-9.34|0.0001
71705591|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Panacea Ratio X 100|114.49|||||TWO_SIDED|90.0|110.68|128.92|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||128.92|110.68|
71705592|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Mylan/Sandoz Ratio X 100|118.77|||||TWO_SIDED|90.0|105.48|133.74|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||133.74|105.48|
71705593|NCT02014103|142929159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% confidence interval falls within 80-125|Geometric Panacea/Sandoz Ratio X 100|103.74|||||TWO_SIDED|90.0|92.13|116.81|||||Bioequivalence is established when 90% confidence interval falls within 80-125|Analysis of variance (PROC MIXED) was performed on log transformed Cmax parameters||116.81|92.13|
71705594|NCT04193176|142929172|SUPERIORITY||Mean Difference (Net)|-11.67||||0.004|TWO_SIDED|95.0|-19.67|-3.67|||ANCOVA|||||-3.67|-19.67|0.004
71705595|NCT02370394|142929187|SUPERIORITY||Mean Difference (Final Values)|-4.14||||0.4016|TWO_SIDED|95.0|-14.02|5.75|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||CAS Victimization Total Score at Follow Up||5.75|-14.02|0.4016
71705596|NCT02370394|142929187|SUPERIORITY||Mean Difference (Net)|14.46||||0.0072|TWO_SIDED|95.0|4.11|24.82|||t-test, 2 sided|||Change in CAS Victimization Total score from Baseline to Follow Up||24.82|4.11|0.0072
71705597|NCT02370394|142929188|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6011|TWO_SIDED|95.0|-0.21|0.12|||t-test, 2 sided|||Safety Behavior Change Score at Follow Up||0.12|-0.21|0.6011
71705598|NCT02370394|142929188|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9116|TWO_SIDED|95.0|-0.16|0.15|||t-test, 2 sided|||Change is Safety Behavior Change Score from Baseline to Follow Up||0.15|-0.16|0.9116
71705599|NCT02370394|142929189|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.8646|TWO_SIDED|95.0|-1.62|1.36|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||EOR Number of issues Effective at Accomplishing at Follow Up||1.36|-1.62|0.8646
71705600|NCT02370394|142929189|SUPERIORITY||Mean Difference (Net)|-0.86||||0.3045|TWO_SIDED|95.0|-2.54|0.82|||t-test, 2 sided|||Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up||0.82|-2.54|0.3045
71705601|NCT02370394|142929190|SUPERIORITY|||||||0.9085|||||||Wilcoxon (Mann-Whitney)|||Motivation Scale at Follow Up||||0.9085
71705602|NCT02370394|142929190|SUPERIORITY|||||||0.3256|||||||Wilcoxon (Mann-Whitney)|||Change in Motivation Scale from Baseline to Follow Up||||0.3256
71705603|NCT02370394|142929191|SUPERIORITY|||||||0.4085|||||||Wilcoxon (Mann-Whitney)|||Readiness at Follow Up||||0.4085
71705604|NCT02370394|142929191|SUPERIORITY|||||||0.2467|||||||Wilcoxon (Mann-Whitney)|||Change in Readiness from Baseline to Follow Up||||0.2467
71705605|NCT01902303|142929195|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Chi-squared|||||||>.5000
71705606|NCT01902303|142929196|SUPERIORITY_OR_OTHER|||||||0.3835|TWO_SIDED||||||Chi-squared|||||||.3835
71705607|NCT00908388|142929266|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||(1-Posterior probability of meeting performance goal given the data)|Bayesian adaptive|||||||.006
71705608|NCT01301001|142929288|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.0|-0.7|0.07
71705609|NCT01301001|142929289|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.76|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||||0.6|-0.9|0.76
71705610|NCT01301001|142929290|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.36|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||||0.2|-0.5|0.36
71705611|NCT00337194|142929312|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.06
71705612|NCT00337194|142929313|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
71705613|NCT01623752|142929322|OTHER|||||||0.278|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.278
71705614|NCT01623752|142929322|OTHER|||||||0.222|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.222
71705615|NCT01623752|142929323|OTHER|||||||0.251|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.251
71705616|NCT01623752|142929323|OTHER|||||||0.218|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.||||0.218
71705617|NCT01623752|142929326|OTHER|||||||0.675|||||||Regression, Linear|||||||0.675
71705618|NCT01623752|142929326|OTHER|||||||0.357|||||||Regression, Linear|||||||0.357
71705619|NCT01623752|142929327|OTHER|||||||0.106|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.106
71705620|NCT01623752|142929327|OTHER|||||||0.181|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.181
71705621|NCT01623752|142929328|OTHER|||||||0.015|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.015
71764022|NCT01065454|143029639|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.07|||||TWO_SIDED|95.0|-22.26|10.13||||||||10.13|-22.26|
71705622|NCT01623752|142929328|OTHER|||||||0.969|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.969
71825854|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.9||||0.9293|TWO_SIDED|95.0|-322.47|294.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||294.66|-322.47|0.9293
71653538|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-9.13|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-12.26|-6.0|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-6.00|-12.26|<.0001
71653539|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.79||0.0008|TWO_SIDED|95.0|-9.51|-2.5|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-2.50|-9.51|0.0008
71653540|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-6.97|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|-10.44|-3.51|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||-3.51|-10.44|<.0001
71653541|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-3.08|STANDARD_ERROR_OF_MEAN|1.87||0.1004|TWO_SIDED|95.0|-6.76|0.6|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.60|-6.76|0.1004
71705623|NCT01623752|142929329|OTHER|||||||0.489|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.489
71705624|NCT01623752|142929329|OTHER|||||||0.386|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.386
71705625|NCT01623752|142929330|OTHER|||||||0.364|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.364
71705626|NCT01623752|142929330|OTHER|||||||0.849|||||||ANOVA|||Statistical analysis (P value) composite for all categories.||||0.849
71705627|NCT02362412|142929377|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-3.4|2.3||p-value was not adjusted|||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||2.3|-3.4|
71705628|NCT02362412|142929378|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-1.7|1.9|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||1.9|-1.7|
71705629|NCT02362412|142929379|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
71705630|NCT02362412|142929380|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.4|-0.3|
71705631|NCT02362412|142929382|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
71705632|NCT02362412|142929383|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.|||0.5|-0.5|
71705633|NCT00165698|142929389|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Symbols rank sum test|||||||0.26
71705634|NCT00165698|142929390|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Symbols rank sum test|||||||0.19
71705635|NCT00165698|142929391|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Symbols rank sum test|||||||0.31
71705636|NCT00165698|142929392|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||symbols rank sum test|||||||0.869
71705637|NCT00165698|142929393|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||symbols rank sum test|||||||0.174
71705638|NCT00165698|142929394|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
71705639|NCT00165698|142929395|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
71705640|NCT00165698|142929396|SUPERIORITY_OR_OTHER|||||||0||95.0|||||symbols rank sum test|||||||0.000
71705641|NCT01107457|142929399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||Fisher Exact|||||||0.079
71705642|NCT01107457|142929399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71705643|NCT01107457|142929399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71705644|NCT01107457|142929399|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71705645|NCT01107457|142929400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71705646|NCT01107457|142929400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71705647|NCT01107457|142929400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71705648|NCT01107457|142929400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71653542|NCT02709486|142824951|SUPERIORITY||Least Square Mean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.86||0.0079|TWO_SIDED|95.0|-8.59|-1.3|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect||-1.30|-8.59|0.0079
71764023|NCT01065454|143029641|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.03|||||TWO_SIDED|95.0|-0.04|0.1||||||||0.10|-0.04|
71764024|NCT01065454|143029641|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.01|||||TWO_SIDED|95.0|-0.07|0.09||||||||0.09|-0.07|
71764025|NCT01065454|143029641|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.02|||||TWO_SIDED|95.0|-0.07|0.11||||||||0.11|-0.07|
71764026|NCT01065454|143029642|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.8|||||TWO_SIDED|95.0|-12.81|-0.78||||||||-0.78|-12.81|
71764027|NCT01065454|143029642|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-6.81|||||TWO_SIDED|95.0|-13.96|0.35||||||||0.35|-13.96|
71764028|NCT01065454|143029642|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-7.5|||||TWO_SIDED|95.0|-15.29|0.28||||||||0.28|-15.29|
71764029|NCT01065454|143029643|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-24.62|||||TWO_SIDED|95.0|-117.58|68.33||||||||68.33|-117.58|
71764030|NCT01065454|143029643|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-53.29|||||TWO_SIDED|95.0|-162.46|55.88||||||||55.88|-162.46|
71764031|NCT01065454|143029643|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-8.36|||||TWO_SIDED|95.0|-135.78|119.06||||||||119.06|-135.78|
71764032|NCT01065454|143029644|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-407.34|||||TWO_SIDED|95.0|-1055.23|240.54||||||||240.54|-1055.23|
71764033|NCT01065454|143029644|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-447.26|||||TWO_SIDED|95.0|-1212.74|318.22||||||||318.22|-1212.74|
71764034|NCT01065454|143029644|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-517.48|||||TWO_SIDED|95.0|-1369.48|334.53||||||||334.53|-1369.48|
71764035|NCT01065454|143029645|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||||||||0.01|-0.01|
71764036|NCT01065454|143029645|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.0||||||||0.00|-0.02|
71764037|NCT01065454|143029645|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
71764038|NCT01065454|143029646|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.03||||||||0.03|-0.04|
71764039|NCT01065454|143029646|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|0.0|||||TWO_SIDED|95.0|-0.04|0.05||||||||0.05|-0.04|
71764040|NCT01065454|143029646|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||||0.03|-0.07|
71764041|NCT01065454|143029647|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANSA Difference|-14.13|||||TWO_SIDED|95.0|-30.79|2.53||||||||2.53|-30.79|
71764042|NCT01065454|143029647|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-12.73|||||TWO_SIDED|95.0|-32.89|7.43||||||||7.43|-32.89|
71764043|NCT01065454|143029647|SUPERIORITY_OR_OTHER_LEGACY||LS-MEANS Difference|-18.27|||||TWO_SIDED|95.0|-41.53|5.0||||||||5.00|-41.53|
71764044|NCT05688670|143029650|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.001|TWO_SIDED|95.0|-0.59|-0.18|||t-test, 2 sided|||||-0.18|-0.59|0.001
71764045|NCT05688670|143029651|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.41|TWO_SIDED|95.0|-0.2|0.08|||t-test, 2 sided|||12-24 hour postoperative opioid use||0.08|-0.20|0.41
71764046|NCT05688670|143029651|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.14|TWO_SIDED|95.0|-0.37|0.06|||t-test, 2 sided|||24-48 hour postoperative opioid use||0.06|-0.37|0.14
71764047|NCT05688670|143029651|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.16|TWO_SIDED|95.0|-0.52|0.09|||t-test, 2 sided|||12-48 hours hours after surgery||0.09|-0.52|0.16
71764048|NCT05688670|143029652|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.004|TWO_SIDED|95.0|-1.02|-0.22|||t-test, 2 sided|||||-0.22|-1.02|0.004
71764049|NCT05688670|143029653|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.002|TWO_SIDED|95.0|-78.9|-20.1|||t-test, 2 sided|||||-20.1|-78.9|0.002
71764050|NCT01808092|143029654|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-4.2||||0.007|TWO_SIDED|95.0|-10.76|2.46||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set||2.46|-10.76|0.007
71764051|NCT01808092|143029655|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-0.7|||<|0.001|TWO_SIDED|95.0|-7.86|6.39||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \<= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set||6.39|-7.86|<0.001
71764052|NCT04219085|143029703|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.0
71764053|NCT04219085|143029704|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71764054|NCT04219085|143029705|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
71764055|NCT01909011|143029711|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71764056|NCT01909011|143029712|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||t-test, 2 sided|||||||0.066
71764057|NCT01909011|143029713|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
71764058|NCT03425253|143029715|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Both Sides of Face, Last Treatment||||<0.001
71764059|NCT03425253|143029715|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Right Side of Face, Last Treatment||||<0.001
71764060|NCT03425253|143029715|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Investigator: Left Side of Face, Last Treatment||||<0.001
71653543|NCT02709486|142824966|SUPERIORITY||Odds Ratio (OR)|0.1||||0.0027|TWO_SIDED|95.0|0.02|0.46|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.46|0.02|0.0027
71653544|NCT02709486|142824966|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0033|TWO_SIDED|95.0|0.05|0.54|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.||0.54|0.05|0.0033
71653545|NCT02709486|142824967|SUPERIORITY|||||||0.0002||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0002
71653546|NCT02709486|142824967|SUPERIORITY|||||||0.0007||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0007
71653547|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.59|0.29|<.0001
71653548|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.78|0.38|0.0010
71705649|NCT01227395|142929434|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.696
71705650|NCT01227395|142929435|SUPERIORITY_OR_OTHER||||||=|0.334|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.334
71705651|NCT01227395|142929436|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
71705652|NCT01227395|142929437|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
71705653|NCT01227395|142929438|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.015
71705654|NCT01227395|142929439|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=1.000
71705655|NCT01227395|142929440|SUPERIORITY_OR_OTHER||||||=|0.29|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.290
71653549|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.70|0.36|<.0001
71705656|NCT01227395|142929441|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.003
71705657|NCT01227395|142929442|SUPERIORITY_OR_OTHER||||||=|0.707|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."||||=0.707
71705658|NCT01398475|142929445|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.02|||||TWO_SIDED|90.0|0.951|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.951|
71705659|NCT01398475|142929445|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.02|||||TWO_SIDED|90.0|0.947|1.09|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.09|0.947|
71705660|NCT01398475|142929445|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.888|||||TWO_SIDED|90.0|0.827|0.953|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.953|0.827|
71705661|NCT01398475|142929446|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|0.979|||||TWO_SIDED|90.0|0.868|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.10|0.868|
71705662|NCT01398475|142929446|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.962|||||TWO_SIDED|90.0|0.852|1.08|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||1.08|0.852|
71705663|NCT01398475|142929446|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.82|||||TWO_SIDED|90.0|0.727|0.925|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.|||0.925|0.727|
71705664|NCT01398475|142929447|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.719|TWO_SIDED|90.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF1 fasted minus RF fasted.|||0.500|-0.250|0.719
71764061|NCT03425253|143029715|OTHER|||||||0.018||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Both Sides of Face, Last Treatment||||0.018
71764062|NCT03425253|143029715|OTHER|||||||0.301||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Right Side of Face, Last Treatment||||0.301
71764063|NCT03425253|143029715|OTHER|||||||0.011||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Independent Reviewer: Left Side of Face, Last Treatment||||0.011
71764064|NCT03425253|143029716|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
71764065|NCT03425253|143029717|OTHER|||||||0.597||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.597
71764066|NCT03425253|143029718|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
71653550|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0067|TWO_SIDED|95.0|0.44|0.88|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.88|0.44|0.0067
71653551|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0087|TWO_SIDED|95.0|0.45|0.89|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.89|0.45|0.0087
71653552|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.74||||0.0787|TWO_SIDED|95.0|0.53|1.04|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.53|0.0787
71653553|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0129|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0129
71705665|NCT01398475|142929447|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.96|TWO_SIDED|90.0|-0.25|0.75|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fasted minus RF fasted.|||0.750|-0.250|0.960
71705666|NCT01398475|142929447|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fed minus TF2 fasted.|||2.00|0|0.006
71705667|NCT00086307|142929452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.018|TWO_SIDED|95.0|1.111|12.541||This is the omnibus effect of drug.|Mixed Models Analysis|||A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.||12.541|1.111|.018
71705668|NCT00086307|142929452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.826|STANDARD_ERROR_OF_MEAN|2.296||0.014|TWO_SIDED|95.0|1.111|12.541||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.||12.541|1.111|.014
71705669|NCT00086307|142929452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.353|STANDARD_ERROR_OF_MEAN|2.296||0.454|TWO_SIDED|95.0|-2.36|9.066||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.||9.066|-2.360|.454
71705670|NCT00086307|142929452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.473|STANDARD_ERROR_OF_MEAN|2.162||0.349|TWO_SIDED|95.0|-1.942|8.888||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.||8.888|-1.942|.349
71705671|NCT03632720|142929479|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95 percent (%) confidence interval (CI) was greater (\>) -10% for all four serogroups.|Difference in Percentage|0.64|||||TWO_SIDED|95.0|-1.78|3.54||||||Serogroup A||3.54|-1.78|
71705672|NCT03632720|142929479|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.24|2.28||||||Serogroup C||2.28|-2.24|
71705673|NCT03632720|142929479|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.33|2.36||||||Serogroup Y||2.36|-2.33|
71705674|NCT03632720|142929479|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for all four serogroups.|Difference in Percentage|-0.58|||||TWO_SIDED|95.0|-3.22|1.81||||||Serogroup W||1.81|-3.22|
71705675|NCT06868667|142929529|OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.11|1.52|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||1.52|0.11|
71705676|NCT05330429|142929555|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.9323|TWO_SIDED|95.0|0.339|2.691|||Unstratified Log-rank Test|2-Sided P-value was based on unstratified log-rank test.|Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||2.691|0.339|0.9323
71705677|NCT05330429|142929558|SUPERIORITY||Hazard Ratio (HR)|0.299|||||TWO_SIDED|95.0|0.056|1.6|||||Hazard ratio and its 95% CI were calculated using unstratified Cox proportional hazards regression model.|||1.600|0.056|
71705678|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.155|||||TWO_SIDED|97.5|1.086|1.229||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.229|1.086|
71653554|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0124|TWO_SIDED|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.47|0.0124
71653555|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0399|TWO_SIDED|95.0|0.5|0.98|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.98|0.50|0.0399
71653556|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.62||||0.006|TWO_SIDED|95.0|0.45|0.87|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.87|0.45|0.0060
71653557|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9449|TWO_SIDED|95.0|0.72|1.42|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.42|0.72|0.9449
71653558|NCT02709486|142824968|SUPERIORITY||Odds Ratio (OR)|0.84||||0.3238|TWO_SIDED|95.0|0.6|1.18|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.18|0.60|0.3238
71653559|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|0.54|0.82|||Negative binomial model|||Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.54|0.0001
71653560|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.08||0.0067|TWO_SIDED|95.0|0.61|0.92|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.61|0.0067
71653561|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.64|STANDARD_ERROR_OF_MEAN|0.08||0.0003|TWO_SIDED|95.0|0.51|0.82|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.82|0.51|0.0003
71653562|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.09||0.0112|TWO_SIDED|95.0|0.58|0.93|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.93|0.58|0.0112
71653563|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.09||0.0093|TWO_SIDED|95.0|0.56|0.92|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.92|0.56|0.0093
71653564|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.09||0.0237|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.96|0.59|0.0237
71653565|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.0374|TWO_SIDED|95.0|0.56|0.98|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.98|0.56|0.0374
71653566|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.11||0.0468|TWO_SIDED|95.0|0.57|1.0|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.57|0.0468
71653567|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11||0.0751|TWO_SIDED|95.0|0.59|1.03|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.03|0.59|0.0751
71653568|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.11||0.1305|TWO_SIDED|95.0|0.61|1.06|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.06|0.61|0.1305
71653569|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.13||0.3057|TWO_SIDED|95.0|0.63|1.16|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.63|0.3057
71705679|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>1.|GMR|1.155|||||TWO_SIDED|95.0|1.094|1.22||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||1.220|1.094|
71764067|NCT03425253|143029719|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
71764068|NCT03425253|143029720|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||<0.001
71764069|NCT03425253|143029721|OTHER|||||||0.003||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||||||0.003
71764070|NCT03425253|143029722|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Both Side of the Face, End of Study||||<0.001
71705680|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.063|||||TWO_SIDED|97.5|0.999|1.13||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.130|0.999|
71705681|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.063|||||TWO_SIDED|95.0|1.007|1.122||||||GMR (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||1.122|1.007|
71705682|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.414|||||TWO_SIDED|97.5|1.322|1.513||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.513|1.322|
71705683|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.414|||||TWO_SIDED|95.0|1.333|1.5||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||1.500|1.333|
71705684|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.38|||||TWO_SIDED|97.5|1.3|1.465||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.465|1.300|
71705685|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.38|||||TWO_SIDED|95.0|1.31|1.454||||||GMR (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||1.454|1.310|
71705686|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.118|||||TWO_SIDED|97.5|1.063|1.175||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.175|1.063|
71705687|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.118|||||TWO_SIDED|95.0|1.07|1.167||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Victoria-lineage Antibody||1.167|1.070|
71705688|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.007|||||TWO_SIDED|97.5|0.969|1.047||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.047|0.969|
71705689|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.007|||||TWO_SIDED|95.0|0.973|1.042||||||GMR (Cohort A1 vs Cohort A2) for Influenza B Yamagata-lineage Antibody||1.042|0.973|
71705690|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.216|||||TWO_SIDED|97.5|1.156|1.278||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.278|1.156|
71705691|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.216|||||TWO_SIDED|95.0|1.163|1.27||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Victoria-lineage Antibody||1.270|1.163|
71705692|NCT06097273|142929569|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.154|||||TWO_SIDED|97.5|1.109|1.201||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.201|1.109|
71705693|NCT06097273|142929569|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.154|||||TWO_SIDED|95.0|1.115|1.195||||||GMR (Cohort B1 vs Cohort B2) for Influenza B Yamagata-lineage Antibody||1.195|1.115|
71705694|NCT06097273|142929570|SUPERIORITY|The superiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.641|||||TWO_SIDED|95.0|1.526|1.765||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.765|1.526|
71705695|NCT06097273|142929570|NON_INFERIORITY|The noninferiority in GM level in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.641|||||TWO_SIDED|97.5|1.51|1.783||||||GMR (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||1.783|1.510|
71705696|NCT06097273|142929570|SUPERIORITY|The superiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the GMR was \>1.|GMR|1.308|||||TWO_SIDED|95.0|1.219|1.404||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.404|1.219|
71705697|NCT06097273|142929570|NON_INFERIORITY|The noninferiority in GM level in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the GMR was \>0.667.|GMR|1.308|||||TWO_SIDED|97.5|1.207|1.418||||||GMR (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||1.418|1.207|
71705698|NCT06097273|142929571|SUPERIORITY|The superiority in seroconversion rate (SCR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.4|8.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.4|2.4|
71705699|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|5.4|||||TWO_SIDED|97.5|1.9|8.8||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H1N1 Antibody||8.8|1.9|
71705700|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.0|||||TWO_SIDED|95.0|1.0|7.1||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.1|1.0|
71764071|NCT03425253|143029722|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Right Side of the Face, End of study||||<0.001
71825855|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|575.71||||0.0003|TWO_SIDED|95.0|268.24|883.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||883.17|268.24|0.0003
71705701|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.0|||||TWO_SIDED|97.5|0.5|7.6||||||Percentage Difference (Cohort A1 vs Cohort A2) for Influenza A H3N2 Antibody||7.6|0.5|
71705702|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.9|7.2||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.2|1.9|
71705703|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|4.5|||||TWO_SIDED|95.0|1.5|7.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for Victoria-lineage Antibody||7.5|1.5|
71705704|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-3.3|0.4||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.4|-3.3|
71705705|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|-1.4|||||TWO_SIDED|97.5|-3.6|0.7||||||Percentage Difference (Cohort A1 vs Cohort A2) for Yamagata-lineage Antibody||0.7|-3.6|
71705706|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|17.9|||||TWO_SIDED|95.0|14.8|21.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.0|14.8|
71764072|NCT03425253|143029722|OTHER||||||<|0.001||||||P-value was based on paired t-test for the mean difference.|Paired t-test|||Left Side of the Face, End of Study||||<0.001
71764073|NCT03844945|143029790|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71705707|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|17.9|||||TWO_SIDED|97.5|14.3|21.4||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H1N1 Antibody||21.4|14.3|
71705708|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|14.6|||||TWO_SIDED|95.0|11.6|17.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||17.6|11.6|
71705709|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|14.6|||||TWO_SIDED|97.5|11.1|18.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Influenza A H3N2 Antibody||18.0|11.1|
71705710|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|8.6|||||TWO_SIDED|95.0|6.0|11.2||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.2|6.0|
71705711|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|8.6|||||TWO_SIDED|97.5|5.6|11.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for Victoria-lineage Antibody||11.6|5.6|
71705712|NCT06097273|142929571|SUPERIORITY|The superiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SCR difference was \>0%.|Percentage Difference|2.7|||||TWO_SIDED|95.0|0.6|4.7||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||4.7|0.6|
71705713|NCT06097273|142929571|NON_INFERIORITY|The noninferiority in SCR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SCR difference was \>-10%.|Percentage Difference|2.7|||||TWO_SIDED|97.5|0.3|5.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for Yamagata-lineage Antibody||5.0|0.3|
71705714|NCT06097273|142929572|SUPERIORITY|The superiority in seroresponse rate (SRR) in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|12.8|||||TWO_SIDED|95.0|10.0|15.5||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.5|10.0|
71705715|NCT06097273|142929572|NON_INFERIORITY|The noninferiority in SRR in the Cohort A1 group compared with that of Cohort A2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|12.8|||||TWO_SIDED|97.5|9.6|15.9||||||Percentage Difference (Cohort A1 vs Cohort A2) for SARS-CoV-2 Antibody||15.9|9.6|
71705716|NCT06097273|142929572|SUPERIORITY|The superiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 95% CI of the SRR difference was \>0%.|Percentage Difference|8.1|||||TWO_SIDED|95.0|5.5|10.6||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||10.6|5.5|
71764074|NCT01043939|143029791|SUPERIORITY_OR_OTHER||Difference of least square means|-0.16||||0.25|TWO_SIDED|95.0|-0.42|0.11||24 participants required to achieve 80% power to detect mean difference of 0.3 in RH-PAT index score between juice groups, assuming standard deviation of the difference was 0.25, using a two-sided significance level of 0.05|Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|The a priori threshold for statistical significance was 0.05.|||0.11|-0.42|0.25
71764075|NCT01043939|143029792|SUPERIORITY_OR_OTHER||Difference of least square means|3.09||||0.29|TWO_SIDED|95.0|-2.73|8.91|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.||||8.91|-2.73|0.29
71764076|NCT01043939|143029793|SUPERIORITY_OR_OTHER||Ratio of means|0.92||||0.15|TWO_SIDED|95.0|0.82|1.03|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|MPO was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||1.03|0.82|0.15
71705717|NCT06097273|142929572|NON_INFERIORITY|The noninferiority in SRR in the Cohort B1 group compared with that of Cohort B2 group was demonstrated if the lower bound of the 97.5% CI of the SRR difference was \>-10%.|Percentage Difference|8.1|||||TWO_SIDED|97.5|5.2|11.0||||||Percentage Difference (Cohort B1 vs Cohort B2) for SARS-CoV-2 Antibody||11.0|5.2|
71705718|NCT05894564|142929583|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.88|1.1|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.10|0.88|
71705719|NCT05894564|142929584|SUPERIORITY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.65|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||5.65|0.05|
71705720|NCT05894564|142929587|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.28|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.28|0.31|
71705721|NCT05894564|142929588|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.56|1.87|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.87|0.56|
71705722|NCT05894564|142929589|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.25|1.16|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.16|0.25|
71764077|NCT01043939|143029794|SUPERIORITY_OR_OTHER||Ratio of means|1.34||||0.37|TWO_SIDED|95.0|0.69|2.62|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period \& group as fixed effects.|hs-CRP was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).|||2.62|0.69|0.37
71764078|NCT04473235|143029795|SUPERIORITY||Mean Difference (Final Values)|-0.799|STANDARD_ERROR_OF_MEAN|1.3||0.531|TWO_SIDED||||||t-test, 2 sided|||||||0.531
71705723|NCT05894564|142929590|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.33|1.74|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.74|0.33|
71705724|NCT05894564|142929591|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.71|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.21|0.71|
71705725|NCT05894564|142929591|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.67|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.19|0.67|
71705726|NCT05894564|142929591|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.61|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.19|0.61|
71705727|NCT05894564|142929591|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.61|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.61|
71705728|NCT05894564|142929591|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.7|1.49|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.49|0.70|
71764079|NCT04473235|143029796|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.627|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the left hippocampus and left prefrontal cortex.||||0.627
71764080|NCT04473235|143029796|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED||||||t-test, 2 sided|||Difference in the connectivity between the right hippocampus and right prefrontal cortex.||||0.120
71764081|NCT02248675|143029827|SUPERIORITY_OR_OTHER|||||||0.153|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||.153
71764082|NCT02248675|143029828|SUPERIORITY_OR_OTHER|||||||0.627|||||||Regression, Linear|||||||.627
71764083|NCT02248675|143029829|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
71764084|NCT02248675|143029830|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment||||||<.001
71653570|NCT02709486|142824970|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.13||0.2056|TWO_SIDED|95.0|0.61|1.11|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.11|0.61|0.2056
71764085|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1334||||0.1695|TWO_SIDED|95.0|-0.0583|0.3251|||Mixed model for repeated measures|||For Grey matter||0.3251|-0.0583|0.1695
71764086|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.175||||0.1057|TWO_SIDED|95.0|-0.038|0.388|||Mixed model for repeated measures|||For posterior cingulate Gyrus||0.3880|-0.0380|0.1057
71764087|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1426||||0.1833|TWO_SIDED|95.0|-0.0691|0.3543|||Mixed model for repeated measures|||For Frontal lobe||0.3543|-0.0691|0.1833
71764088|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1366||||0.1644|TWO_SIDED|95.0|-0.0574|0.3307|||Mixed model for repeated measures|||For parietal lobe||0.3307|-0.0574|0.1644
71764089|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1259||||0.1509|TWO_SIDED|95.0|-0.0471|0.2989|||Mixed model for repeated measures|||For Posterior temporal lobe||0.2989|-0.0471|0.1509
71764090|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1339||||0.2041|TWO_SIDED|95.0|-0.0747|0.3424|||Mixed model for repeated measures|||For cerebellum||0.3424|-0.0747|0.2041
71764091|NCT00265148|143029839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1094||||0.1445|TWO_SIDED|95.0|-0.0385|0.2572|||Mixed model for repeated measures|||For medial temporal lobe||0.2572|-0.0385|0.1445
71764092|NCT00265148|143029840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1211||||0.2251|TWO_SIDED|95.0|-0.0763|0.3185|||Mixed model for repeated measures|||At Month 1||0.3185|-0.0763|0.2251
71764093|NCT00265148|143029840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0893||||0.2497|TWO_SIDED|95.0|-0.0643|0.243|||Mixed model for repeated measures|||For Month 6||0.2430|-0.0643|0.2497
71764094|NCT00265148|143029841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.11||||0.7618|TWO_SIDED|95.0|-0.59|0.8|||Repeated measure mixed model|||For BSR test , Month 1||0.80|-0.59|0.7618
71705729|NCT05894564|142929592|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.80|
71764095|NCT00265148|143029841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.06||||0.835|TWO_SIDED|95.0|-0.53|0.66|||Repeated measure mixed model|||For BSR test, Month 6||0.66|-0.53|0.8350
71705730|NCT05894564|142929592|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.77|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.26|0.77|
71764096|NCT00265148|143029841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14||||0.6735|TWO_SIDED|95.0|-0.78|0.51|||Repeated measure mixed model|||For BSR test, Month 12||0.51|-0.78|0.6735
71764097|NCT00265148|143029842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.7045|TWO_SIDED|95.0|-0.44|0.3|||Repetaed measure mixed model|||For Month 1||0.30|-0.44|0.7045
71764098|NCT00265148|143029842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.8181|TWO_SIDED|95.0|-0.4|0.32|||Repeated measure mixed model|||For Month 6||0.32|-0.40|0.8181
71764099|NCT00265148|143029842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.7688|TWO_SIDED|95.0|-0.71|0.53|||Repeated measure mixed model|||AT Month 12||0.53|-0.71|0.7688
71653571|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.0441|TWO_SIDED|95.0|0.39|0.99|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||0.99|0.39|0.0441
71705731|NCT05894564|142929592|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.67|
71705732|NCT05894564|142929592|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.77|
71705733|NCT05894564|142929592|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.76|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.33|0.76|
71705734|NCT05894564|142929593|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.65|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.09|0.65|
71705735|NCT05894564|142929593|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
71705736|NCT05894564|142929593|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.21|0.64|
71705737|NCT05894564|142929593|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.87|1.73|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.73|0.87|
71705738|NCT05894564|142929593|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.85|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.64|0.85|
71705739|NCT05894564|142929594|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.74|
71705740|NCT05894564|142929594|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.59|1.1|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.10|0.59|
71705741|NCT05894564|142929594|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.59|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.59|
71705742|NCT05894564|142929594|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.83|1.62|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.62|0.83|
71705743|NCT05894564|142929594|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.34|0.70|
71705744|NCT05894564|142929595|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.79|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.34|0.79|
71764100|NCT00265148|143029842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07||||0.681|TWO_SIDED|95.0|-0.4|0.26|||Repeated measure mixed model|||Overall||0.26|-0.40|0.6810
71653572|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.17||0.1895|TWO_SIDED|95.0|0.46|1.17|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.17|0.46|0.1895
71653573|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0567|TWO_SIDED|95.0|0.35|1.01|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.01|0.35|0.0567
71653574|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.2||0.296|TWO_SIDED|95.0|0.44|1.28|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.44|0.2960
71653575|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.65|STANDARD_ERROR_OF_MEAN|0.18||0.1215|TWO_SIDED|95.0|0.37|1.12|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.12|0.37|0.1215
71653576|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.22||0.3569|TWO_SIDED|95.0|0.44|1.34|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.34|0.44|0.3569
71653577|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.21||0.2096|TWO_SIDED|95.0|0.36|1.25|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.25|0.36|0.2096
71653578|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.22||0.2387|TWO_SIDED|95.0|0.37|1.28|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.28|0.37|0.2387
71653579|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.71|STANDARD_ERROR_OF_MEAN|0.22||0.2627|TWO_SIDED|95.0|0.39|1.29|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.29|0.39|0.2627
71653580|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.22||0.2863|TWO_SIDED|95.0|0.4|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group||1.31|0.40|0.2863
71653581|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.27||0.556|TWO_SIDED|95.0|0.43|1.58|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.58|0.43|0.5560
71705745|NCT05894564|142929595|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.74|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.32|0.74|
71764101|NCT00265148|143029846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.8593|TWO_SIDED|95.0|-2.38|1.99|||Repeated measure mixed model|||At Month 1||1.99|-2.38|0.8593
71764102|NCT00265148|143029846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.44||||0.3201|TWO_SIDED|95.0|-1.43|4.32|||Repeated measure mixed model|||At Month 6||4.32|-1.43|0.3201
71764103|NCT00265148|143029846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.18||||0.2627|TWO_SIDED|95.0|-1.68|6.04|||Repeated measure mixed model|||At Month 12||6.04|-1.68|0.2627
71764104|NCT00265148|143029846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.14||||0.3633|TWO_SIDED|95.0|-1.35|3.64|||Repeated measure mixed model|||For overall period||3.64|-1.35|0.3633
71764105|NCT00265148|143029847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.11||||0.5647|TWO_SIDED|95.0|-0.48|0.26|||Repetaed measure mixed model|||For overall period||0.26|-0.48|0.5647
71764106|NCT00265148|143029847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9935|TWO_SIDED|95.0|-0.46|0.46|||Repeated measure mixed model|||For Month 1||0.46|-0.46|0.9935
71764107|NCT00265148|143029847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22||||0.3794|TWO_SIDED|95.0|-0.72|0.28|||Repeated measure mixed model|||At Month 6||0.28|-0.72|0.3794
71764108|NCT00265148|143029847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.7357|TWO_SIDED|95.0|-0.7|0.49|||Repeated measure mixed model|||At Month 12||0.49|-0.70|0.7357
71764109|NCT00265148|143029850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4971.6||||0.6299|TWO_SIDED|95.0|-255515.6|15572.4|||Repeated measure mixed model|Arithmetic means have been presented; however, statistical analysis is based upon the least square (LS) means||At Month 6||15572.4|-255515.6|0.6299
71764110|NCT00265148|143029850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12223.0||||0.2184|TWO_SIDED|95.0|-7450.6|31896.5|||Repeated measure mixed model|||At Month 12||31896.5|-7450.6|0.2184
71764111|NCT00265148|143029851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0129|TWO_SIDED|95.0|-1.0|-0.1|||Repeated measure mixed model|||For Month 6||-0.1|-1.0|0.0129
71764112|NCT00265148|143029851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.5607|TWO_SIDED|95.0|-1.0|0.6|||Repeated measure mixed model|||For Month 12||0.6|-1.0|0.5607
71653582|NCT02709486|142824972|SUPERIORITY||LS Mean Ratio|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.5076|TWO_SIDED|95.0|0.42|1.53|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.53|0.42|0.5076
71653583|NCT04179019|142824992|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||The intra-individual, paired, 24h urine aldosterone excretion rate following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment 24h urine aldosterone excretion rate. The null hypothesis was that amlodipine therapy would result in no change in the 24h urine aldosterone excretion rate. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.96
71653584|NCT04179019|142824993|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||The intra-individual, paired, plasma aldosterone concentration following 2 weeks of amlodipine therapy was compared to the baseline pre-treatment aldosterone concentration. The null hypothesis was that amlodipine therapy would result in no change in the plasma aldosterone value. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.29
71653585|NCT04179019|142824994|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||The intra-individual, paired, change in plasma aldosterone concentration in response to an acute dose of amlodipine (6h post-dose) was compared to the baseline pre-treatment response to an acute dose of amlodipine. The null hypothesis was that an acute amlodipine dose would result in no acute change in the plasma aldosterone levels. Because only 2 participants completed the pilot study, the validity of the results is low.||||0.83
71653586|NCT02610816|142824995|SUPERIORITY|||||||0.04||||||P-values are not adjusted for multiplicity, since a single primary endpoint is analyzed|Mixed Models Analysis|No adjustment of degrees of freedom is needed.||The primary treatment comparison was to compare change in PEESS V2.0 scores of 1FED versus 4FED. The primary null hypothesis was 4FED would be no more effective than 1FED. This was designed as a superiority trial.||||0.04
71653587|NCT02610816|142824996|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05.|Mixed Models Analysis|||||||<0.0001
71653588|NCT02610816|142824996|SUPERIORITY||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p \<0.05|Mixed Models Analysis|||||||<0.0001
71653589|NCT02610816|142824997|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71653590|NCT02610816|142825000|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
71653591|NCT02610816|142825001|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71653592|NCT02610816|142825002|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|||||||0.36
71653593|NCT02691741|142825010|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193|||TWO_SIDED|90.0|-0.093|-0.029||||||||-0.029|-0.093|
71653594|NCT02691741|142825011|SUPERIORITY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.0193||0.002|TWO_SIDED|90.0|-0.093|-0.029|||Repeated Measures Analysis of Variance|||||-0.029|-0.093|0.002
71653595|NCT02691741|142825012|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.019|0.043||||||||0.043|-0.019|
71653596|NCT02691741|142825012|SUPERIORITY|||||||0.455|||||||Repeated Measures Analysis of Variance|||||||0.455
71653597|NCT02691741|142825013|NON_INFERIORITY|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.0168|||TWO_SIDED|90.0|-0.078|-0.023||||||||-0.023|-0.078|
71653598|NCT02691741|142825013|SUPERIORITY|||||||0.003|||||||Repeated Measures Analysis of Variance|||||||0.003
71653599|NCT02139124|142825020|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.675|TWO_SIDED|95.0|-6.6|2.6||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo."||2.6|-6.6|0.6750
71764113|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1154||||0.28|TWO_SIDED|95.0|-0.0967|0.3275|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status positive||0.3275|-0.0967|0.2800
71764114|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1337||||0.4159||95.0|-0.1931|0.4605|||Repeated measure mixed model|||For Grey matter, APOE Epsilon-4 status negative||0.4605|-0.1931|0.4159
71705746|NCT05894564|142929595|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.64|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.64|
71705747|NCT05894564|142929595|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.7|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.34|0.70|
71705748|NCT05894564|142929595|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.64|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.25|0.64|
71764115|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1491||||0.2158|TWO_SIDED|95.0|-0.0897|0.3878|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status positive||0.3878|-0.0897|0.2158
71764116|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2346||||0.2087|TWO_SIDED|95.0|-0.135|0.6042|||Repeated measure mixed model|||For posterior cingulate gyrus, APOE Epsilon-4 status negative||0.6042|-0.1350|0.2087
71764117|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1233||||0.3064|TWO_SIDED|95.0|-0.1162|0.3628|||Repeated measure mixed model|||For Frontal lobe, APOE Epsilon-4 status positive||0.3628|-0.1162|0.3064
71764118|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1734||||0.35|TWO_SIDED|95.0|-0.1952|0.542|||Repeated measure mixed model|||For Frontal lobe APOE Epsilon-4 status negative||0.5420|-0.1952|0.3500
71764119|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13||||0.2487|TWO_SIDED|95.0|-0.0937|0.3538|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status positive||0.3538|-0.0937|0.2487
71764120|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1038||||0.5521|TWO_SIDED|95.0|-0.244|0.4516|||Repeated measure mixed model|||For parietal lobe, APOE Epsilon-4 status negative||0.4516|-0.2440|0.5521
71764121|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1384||||0.176|TWO_SIDED|95.0|-0.064|0.3409|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status positive||0.3409|-0.0640|0.1760
71764122|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0837||||0.5952|TWO_SIDED|95.0|-0.2303|0.3978|||Repeated measure mixed model|||For posterior temporal lobe, APOE Epsilon-4 status negative||0.3978|-0.2303|0.5952
71764123|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0847||||0.4025|TWO_SIDED|95.0|-0.1169|0.2863|||Repeated measure mixed model|||For Cerebellum, APOE Epsilon-4 status positive||0.2863|-0.1169|0.4025
71764124|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.3081|TWO_SIDED|95.0|-0.1458|0.453|||Repeated measure mixed model95|||For Cerebellum, APOE Epsilon-4 status negative||0.4530|-0.1458|0.3081
71764125|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0839||||0.2964|TWO_SIDED|95.0|-0.0758|0.2436|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status positive||0.2436|-0.0758|0.2964
71764126|NCT00265148|143029863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1536||||0.2101|TWO_SIDED|95.0|-0.0892|0.3963|||Repeated measure mixed model|||For medial temporal lobe, APOE Epsilon-4 status negative||0.3963|-0.0892|0.2101
71705749|NCT05894564|142929596|OTHER||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.61|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.01|0.61|
71764127|NCT01068964|143029887|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 1.5 mmHg was used. That is, if the upper limit of the 95% confidence interval for the difference in the mean diurnal IOP change between the two groups (Group 1 minus Group 2) is less than 1.5 mm Hg, then the null hypothesis will be rejected. The study had an 85% power.|Mean Difference (Final Values)|-0.556|||||TWO_SIDED|95.0|-1.68|0.57||||||A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.||0.57|-1.68|
71764128|NCT01523275|143029895|EQUIVALENCE|Analysis of 44 subjects (22 in each arm) would provide 90% power to detect a difference in the time interval to reoperation of 6 months between the two treatment arms, at an alpha level of 0.05. This difference of 6 months is clinically meaningful and is smaller than previous case series studies would suggest. However, due to poor patient accrual, the study was closed prior to reaching the desired study size.||||||0.95|||||||t-test, 2 sided|||||||0.95
71764129|NCT01523275|143029896|EQUIVALENCE|A difference of 6 months to symptom progression is clinically meaningful.||||||0.52|||||||t-test, 2 sided|||||||0.52
71764130|NCT01523275|143029897|EQUIVALENCE|0.5 liters per second is clinically significant.||||||0.64|||||||t-test, 2 sided|||||||0.64
71764131|NCT03630770|143029898|OTHER||Rate Ratio|0.98||||0.9|TWO_SIDED|95.0|0.55|1.7||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the control group.||1.7|0.55|0.9
71764132|NCT03630770|143029898|OTHER||Rate Ratio|8.1|||<|0.001|TWO_SIDED|95.0|2.6|25.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the control group.||25|2.6|<0.001
71775048|NCT00580970|143050302|SUPERIORITY_OR_OTHER|||||||0.9138||||||Considering all late rectal toxicities, 38% (20/53) of participants developed physician reported Grade 2 or higher GI toxicity during 2 year follow up. The threshold for significance was p \< 0.05.|t-test, 1 sided|A one sided t-test, with 5% level of significance, and 83% power was used which required 53 subjects.||||||0.9138
71705750|NCT05894564|142929596|OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.64|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.11|0.64|
71705751|NCT05894564|142929596|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.12|0.63|
71764133|NCT03630770|143029898|OTHER||Rate Ratio|0.15||||0.02|TWO_SIDED|95.0|0.03|0.75||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (before v. during supplementation) for the MCT group.||0.75|0.03|0.02
71764134|NCT03630770|143029898|OTHER||Rate Ratio|61.0|||<|0.001|TWO_SIDED|95.0|6.9|533.0||p-values underwent generalized estimating equations adjustment for multiple measures per individuals within time.|Negative binomial regression|||Stool fungal counts (cfu/g) were compared between groups using negative binomial regression within time period (before, during, after). Rate ratio was calculated to reflect the direction and magnitude of change in stool colony counts between time periods (during v. after supplementation) for the MCT group.||533|6.9|<0.001
71764135|NCT00689117|143029899|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.063
71764136|NCT00689117|143029899|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.003
71764137|NCT00689117|143029899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71764138|NCT00689117|143029899|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.004
71653600|NCT02139124|142825020|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.0013|TWO_SIDED|95.0|-11.5|-2.2||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo||-2.2|-11.5|0.0013
71653601|NCT02139124|142825020|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.672|TWO_SIDED|95.0|-6.8|2.7||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||2.7|-6.8|0.6720
71653602|NCT02139124|142825020|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0002|TWO_SIDED|95.0|-12.9|-3.2||The model include terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett's adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"||-3.2|-12.9|0.0002
71653603|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.5|||||TWO_SIDED|90.0|-5.41|-1.59|||Mixed Models Analysis|||30 minutes postdose||-1.59|-5.41|
71653604|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.54|||||TWO_SIDED|90.0|-5.18|-1.89|||Mixed Models Analysis|||1 hour postdose||-1.89|-5.18|
71764139|NCT00689117|143029899|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.550
71764140|NCT00689117|143029899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71764141|NCT00689117|143029899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
71764142|NCT00689117|143029899|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Total lesion count|Ranked ANCOVA|||||||0.016
71653605|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.1|||||TWO_SIDED|90.0|-5.77|-2.43|||Mixed Models Analysis|||1.5 hours postdose||-2.43|-5.77|
71653606|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.21|||||TWO_SIDED|90.0|-5.14|-1.28|||Mixed Models Analysis|||2 hours postdose||-1.28|-5.14|
71705752|NCT05894564|142929596|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.6|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.12|0.60|
71764143|NCT00689117|143029899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
71764144|NCT00689117|143029900|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||0.001
71764145|NCT00689117|143029900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
71764146|NCT00689117|143029900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel|||||||<0.001
71764147|NCT00689117|143029901|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.065
71764148|NCT00689117|143029901|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||0.002
71764149|NCT00689117|143029901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71764150|NCT00689117|143029901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71764151|NCT00689117|143029901|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||0.284
71764152|NCT00689117|143029901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-inflammatory lesion count|Ranked ANCOVA|||||||<0.001
71764153|NCT00689117|143029901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
71764154|NCT00689117|143029901|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||Total lesion count|Ranked ANCOVA|||||||0.028
71764155|NCT00689117|143029901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total lesion count|Ranked ANCOVA|||||||<0.001
71653607|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.46|||||TWO_SIDED|90.0|-4.41|-0.51|||Mixed Models Analysis|||2.5 hours postdose||-0.51|-4.41|
71653608|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.91|||||TWO_SIDED|90.0|-2.84|1.03|||Mixed Models Analysis|||3 hours postdose||1.03|-2.84|
71653609|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.62|||||TWO_SIDED|90.0|-2.53|1.29|||Mixed Models Analysis|||3.5 hours postdose||1.29|-2.53|
71653610|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.07|||||TWO_SIDED|90.0|-1.84|1.99|||Mixed Models Analysis|||4 hours postdose||1.99|-1.84|
71653611|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.06|||||TWO_SIDED|90.0|-3.22|1.1|||Mixed Models Analysis|||6 hours postdose||1.10|-3.22|
71653612|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.73|||||TWO_SIDED|90.0|-4.88|-0.57|||Mixed Models Analysis|||8 hours postdose||-0.57|-4.88|
71653613|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.05|||||TWO_SIDED|90.0|-3.77|-0.32|||Mixed Models Analysis|||12 hours postdose||-0.32|-3.77|
71653614|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.21|||||TWO_SIDED|90.0|-1.9|2.33|||Mixed Models Analysis|||24 hours postdose||2.33|-1.90|
71653615|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.83|||||TWO_SIDED|90.0|-5.56|-2.11|||Mixed Models Analysis|||30 minutes postdose||-2.11|-5.56|
71653616|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.75|||||TWO_SIDED|90.0|-2.75|1.25|||Mixed Models Analysis|||1 hour postdose||1.25|-2.75|
71653617|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.45|||||TWO_SIDED|90.0|-1.49|2.38|||Mixed Models Analysis|||1.5 hours postdose||2.38|-1.49|
71653618|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.58|||||TWO_SIDED|90.0|0.58|4.58|||Mixed Models Analysis|||2 hours postdose||4.58|0.58|
71764156|NCT00689117|143029902|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Cochran-Mantel-Haenszel|||||||0.671
71764157|NCT00689117|143029902|SUPERIORITY_OR_OTHER|||||||0.919||95.0|||||Cochran-Mantel-Haenszel|||||||0.919
71653619|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.85|||||TWO_SIDED|90.0|0.73|4.98|||Mixed Models Analysis|||2.5 hours postdose||4.98|0.73|
71653620|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.94|||||TWO_SIDED|90.0|1.85|6.03|||Mixed Models Analysis|||3 hours postdose||6.03|1.85|
71653621|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.28|||||TWO_SIDED|90.0|3.61|6.95|||Mixed Models Analysis|||3.5 hours postdose||6.95|3.61|
71653622|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|6.94|||||TWO_SIDED|90.0|4.99|8.89|||Mixed Models Analysis|||4 hours postdose||8.89|4.99|
71653623|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.13|||||TWO_SIDED|90.0|0.93|5.34|||Mixed Models Analysis|||6 hours postdose||5.34|0.93|
71653624|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.09|||||TWO_SIDED|90.0|-0.23|4.4|||Mixed Models Analysis|||8 hours postdose||4.40|-0.23|
71653625|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.37|||||TWO_SIDED|90.0|-0.57|3.3|||Mixed Models Analysis|||12 hours postdose||3.30|-0.57|
71653626|NCT03465436|142825021|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.29|||||TWO_SIDED|90.0|-2.21|1.63|||Mixed Models Analysis|||24 hours postdose||1.63|-2.21|
71653627|NCT03465436|142825021|SUPERIORITY||LS Mean|7.32|||||TWO_SIDED|90.0|5.03|9.6|||Mixed Models Analysis|||30 minutes postdose||9.60|5.03|
71653628|NCT03465436|142825021|SUPERIORITY||LS Mean|12.28|||||TWO_SIDED|90.0|10.47|14.1|||Mixed Models Analysis|||1 hour postdose||14.10|10.47|
71653629|NCT03465436|142825021|SUPERIORITY||LS Mean|11.27|||||TWO_SIDED|90.0|9.54|13.0|||Mixed Models Analysis|||1.5 hours postdose||13.00|9.54|
71653630|NCT03465436|142825021|SUPERIORITY||LS Mean|11.92|||||TWO_SIDED|90.0|9.97|13.87|||Mixed Models Analysis|||2 hours postdose||13.87|9.97|
71653631|NCT03465436|142825021|SUPERIORITY||LS Mean|10.98|||||TWO_SIDED|90.0|9.17|12.79|||Mixed Models Analysis|||2.5 hours postdose||12.79|9.17|
71653632|NCT03465436|142825021|SUPERIORITY||LS Mean|11.99|||||TWO_SIDED|90.0|10.1|13.87|||Mixed Models Analysis|||3 hours postdose||13.87|10.10|
71764158|NCT00689117|143029902|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
71764159|NCT00689117|143029903|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|||||||0.002
71764160|NCT00689117|143029903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71764161|NCT00689117|143029903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71764162|NCT01086358|143029913|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.007|TWO_SIDED|95.0|-2.92|-0.49|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.49|-2.92|0.007
71764163|NCT01086358|143029914|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.01|TWO_SIDED|95.0|-1.79|-0.27|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||-0.27|-1.79|0.010
71653633|NCT03465436|142825021|SUPERIORITY||LS Mean|12.19|||||TWO_SIDED|90.0|10.32|14.05|||Mixed Models Analysis|||3.5 hours postdose||14.05|10.32|
71653634|NCT03465436|142825021|SUPERIORITY||LS Mean|11.68|||||TWO_SIDED|90.0|9.83|13.52|||Mixed Models Analysis|||4 hours postdose||13.52|9.83|
71653635|NCT03465436|142825021|SUPERIORITY||LS Mean|8.24|||||TWO_SIDED|90.0|6.1|10.39|||Mixed Models Analysis|||6 hours postdose||10.39|6.10|
71653636|NCT03465436|142825021|SUPERIORITY||LS Mean|7.87|||||TWO_SIDED|90.0|5.66|10.07|||Mixed Models Analysis|||8 hours postdose||10.07|5.66|
71653637|NCT03465436|142825021|SUPERIORITY||LS Mean|6.35|||||TWO_SIDED|90.0|4.32|8.38|||Mixed Models Analysis|||12 hours postdose||8.38|4.32|
71653638|NCT03465436|142825021|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|3.88|8.38|||Mixed Models Analysis|||24 hours postdose||8.38|3.88|
71653639|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.49|||||TWO_SIDED|90.0|-6.47|-2.52|||Mixed Models Analysis|||30 minutes postdose||-2.52|-6.47|
71653640|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.3|||||TWO_SIDED|90.0|-7.18|-3.42|||Mixed Models Analysis|||1 hour postdose||-3.42|-7.18|
71653641|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.7|||||TWO_SIDED|90.0|-7.57|-3.82|||Mixed Models Analysis|||1.5 hours postdose||-3.82|-7.57|
71653642|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.47|||||TWO_SIDED|90.0|-6.64|-2.3|||Mixed Models Analysis|||2 hours postdose||-2.30|-6.64|
71653643|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.53|||||TWO_SIDED|90.0|-6.87|-2.19|||Mixed Models Analysis|||2.5 hours postdose||-2.19|-6.87|
71653644|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.74|||||TWO_SIDED|90.0|-4.9|-0.59|||Mixed Models Analysis|||3 hours postdose||-0.59|-4.90|
71653645|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.74|||||TWO_SIDED|90.0|-3.86|0.39|||Mixed Models Analysis|||3.5 hours postdose||0.39|-3.86|
71653646|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.66|||||TWO_SIDED|90.0|-3.77|0.44|||Mixed Models Analysis|||4 hours postdose||0.44|-3.77|
71653647|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.11|||||TWO_SIDED|90.0|-3.17|0.94|||Mixed Models Analysis|||6 hours postdose||0.94|-3.17|
71653648|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.47|||||TWO_SIDED|90.0|-4.58|-0.35|||Mixed Models Analysis|||8 hours postdose||-0.35|-4.58|
71653649|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.15|||||TWO_SIDED|90.0|-3.87|-0.43|||Mixed Models Analysis|||12 hours postdose||-0.43|-3.87|
71653650|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.79|||||TWO_SIDED|90.0|-1.14|2.72|||Mixed Models Analysis|||24 hours postdose||2.72|-1.14|
71653651|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.64|||||TWO_SIDED|90.0|-6.57|-2.71|||Mixed Models Analysis|||30 minutes postdose||-2.71|-6.57|
71653652|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.49|||||TWO_SIDED|90.0|-4.59|-0.39|||Mixed Models Analysis|||1 hour postdose||-0.39|-4.59|
71653653|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.96|||||TWO_SIDED|90.0|-3.02|1.09|||Mixed Models Analysis|||1.5 hours postdose||1.09|-3.02|
71653654|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.64|||||TWO_SIDED|90.0|-0.46|3.73|||Mixed Models Analysis|||2 hours postdose||3.73|-0.46|
71653655|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.61|||||TWO_SIDED|90.0|-0.59|3.81|||Mixed Models Analysis|||2.5 hours postdose||3.81|-0.59|
71653656|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.41|||||TWO_SIDED|90.0|0.25|4.57|||Mixed Models Analysis|||3 hours postdose||4.57|0.25|
71653657|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|4.3|||||TWO_SIDED|90.0|2.48|6.12|||Mixed Models Analysis|||3.5 hours postdose||6.12|2.48|
71653658|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.15|||||TWO_SIDED|90.0|3.02|7.27|||Mixed Models Analysis|||4 hours postdose||7.27|3.02|
71705753|NCT05894564|142929596|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.67|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.24|0.67|
71653659|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.77|||||TWO_SIDED|90.0|0.75|4.79|||Mixed Models Analysis|||6 hours postdose||4.79|0.75|
71653660|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.55|4.05|||Mixed Models Analysis|||8 hours postdose||4.05|-0.55|
71653661|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||TWO_SIDED|90.0|-0.19|3.69|||Mixed Models Analysis|||12 hours postdose||3.69|-0.19|
71653662|NCT03465436|142825022|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.48|||||TWO_SIDED|90.0|-2.44|1.48|||Mixed Models Analysis|||24 hours postdose||1.48|-2.44|
71653663|NCT03465436|142825022|SUPERIORITY||LS Mean|7.07|||||TWO_SIDED|90.0|4.72|9.41|||Mixed Models Analysis|||30 minutes postdose||9.41|4.72|
71653664|NCT03465436|142825022|SUPERIORITY||LS Mean|11.81|||||TWO_SIDED|90.0|9.94|13.69|||Mixed Models Analysis|||1 hour postdose||13.69|9.94|
71653665|NCT03465436|142825022|SUPERIORITY||LS Mean|10.95|||||TWO_SIDED|90.0|9.16|12.74|||Mixed Models Analysis|||1.5 hours postdose||12.74|9.16|
71653666|NCT03465436|142825022|SUPERIORITY||LS Mean|11.5|||||TWO_SIDED|90.0|9.5|13.43|||Mixed Models Analysis|||2 hours postdose||13.43|9.5|
71653667|NCT03465436|142825022|SUPERIORITY||LS Mean|10.81|||||TWO_SIDED|90.0|8.9|12.71|||Mixed Models Analysis|||2.5 hours postdose||12.71|8.9|
71653668|NCT03465436|142825022|SUPERIORITY||LS Mean|12.35|||||TWO_SIDED|90.0|10.42|14.28|||Mixed Models Analysis|||3 hours postdose||14.28|10.42|
71653669|NCT03465436|142825022|SUPERIORITY||LS Mean|12.65|||||TWO_SIDED|90.0|10.76|14.54|||Mixed Models Analysis|||3.5 hours postdose||14.54|10.76|
71653670|NCT03465436|142825022|SUPERIORITY||LS Mean|11.17|||||TWO_SIDED|90.0|9.23|13.1|||Mixed Models Analysis|||4 hours postdose||13.10|9.23|
71653671|NCT03465436|142825022|SUPERIORITY||LS Mean|8.12|||||TWO_SIDED|90.0|6.02|10.22|||Mixed Models Analysis|||6 hours postdose||10.22|6.02|
71653672|NCT03465436|142825022|SUPERIORITY||LS Mean|8.1|||||TWO_SIDED|90.0|6.01|10.19|||Mixed Models Analysis|||8 hours postdose||10.19|6.01|
71653673|NCT03465436|142825022|SUPERIORITY||LS Mean|6.26|||||TWO_SIDED|90.0|4.23|8.28|||Mixed Models Analysis|||12 hours postdose||8.28|4.23|
71653674|NCT03465436|142825022|SUPERIORITY||LS Mean|5.74|||||TWO_SIDED|90.0|3.47|8.01|||Mixed Models Analysis|||24 hours postdose||8.01|3.47|
71653675|NCT03465436|142825023|SUPERIORITY||LS Mean|32.89|||||TWO_SIDED|90.0|11.5|54.28|||Mixed Models Analysis|||30 minutes postdose||54.28|11.50|
71653676|NCT03465436|142825023|SUPERIORITY||LS Mean|100.15|||||TWO_SIDED|90.0|77.81|122.5|||Mixed Models Analysis|||1 hour postdose||122.50|77.81|
71653677|NCT03465436|142825023|SUPERIORITY||LS Mean|107.11|||||TWO_SIDED|90.0|83.31|130.91|||Mixed Models Analysis|||1.5 hours postdose||130.91|83.31|
71653678|NCT03465436|142825023|SUPERIORITY||LS Mean|74.48|||||TWO_SIDED|90.0|56.32|92.63|||Mixed Models Analysis|||2 hours postdose||92.63|56.32|
71653679|NCT03465436|142825023|SUPERIORITY||LS Mean|89.19|||||TWO_SIDED|90.0|68.77|109.61|||Mixed Models Analysis|||2.5 hours postdose||109.61|68.77|
71653680|NCT03465436|142825023|SUPERIORITY||LS Mean|74.98|||||TWO_SIDED|90.0|55.41|94.55|||Mixed Models Analysis|||3 hours postdose||94.55|55.41|
71653681|NCT03465436|142825023|SUPERIORITY||LS Mean|52.83|||||TWO_SIDED|90.0|36.03|69.63|||Mixed Models Analysis|||3.5 hours postdose||69.63|36.03|
71653682|NCT03465436|142825023|SUPERIORITY||LS Mean|42.1|||||TWO_SIDED|90.0|24.86|59.35|||Mixed Models Analysis|||4 hours postdose||59.35|24.86|
71653683|NCT03465436|142825023|SUPERIORITY||LS Mean|62.61|||||TWO_SIDED|90.0|42.39|82.83|||Mixed Models Analysis|||6 hours postdose||82.83|42.39|
71653684|NCT03465436|142825023|SUPERIORITY||LS Mean|56.05|||||TWO_SIDED|90.0|32.49|79.61|||Mixed Models Analysis|||8 hours postdose||79.61|32.49|
71653685|NCT03465436|142825023|SUPERIORITY||LS Mean|35.71|||||TWO_SIDED|90.0|11.79|59.63|||Mixed Models Analysis|||12 hours postdose||59.63|11.79|
71653686|NCT03465436|142825023|SUPERIORITY||LS Mean|-4.59|||||TWO_SIDED|90.0|-24.66|15.47|||Mixed Models Analysis|||24 hours postdose||15.47|-24.66|
71653687|NCT03465436|142825023|SUPERIORITY||LS Mean|56.53|||||TWO_SIDED|90.0|36.72|76.35|||Mixed Models Analysis|||30 minutes postdose||76.35|36.72|
71653688|NCT03465436|142825023|SUPERIORITY||LS Mean|103.3|||||TWO_SIDED|90.0|83.88|122.72|||Mixed Models Analysis|||1 hour postdose||122.72|83.88|
71653689|NCT03465436|142825023|SUPERIORITY||LS Mean|94.21|||||TWO_SIDED|90.0|75.15|113.26|||Mixed Models Analysis|||1.5 hours postdose||113.26|75.15|
71653690|NCT03465436|142825023|SUPERIORITY||LS Mean|83.49|||||TWO_SIDED|90.0|67.98|99.0|||Mixed Models Analysis|||2 hours postdose||99.00|67.98|
71653691|NCT03465436|142825023|SUPERIORITY||LS Mean|103.64|||||TWO_SIDED|90.0|87.28|120.0|||Mixed Models Analysis|||2.5 hours postdose||120.00|87.28|
71653692|NCT03465436|142825023|SUPERIORITY||LS Mean|89.26|||||TWO_SIDED|90.0|71.24|107.29|||Mixed Models Analysis|||3 hours postdose||107.29|71.24|
71653693|NCT03465436|142825023|SUPERIORITY||LS Mean|65.29|||||TWO_SIDED|90.0|48.28|82.3|||Mixed Models Analysis|||3.5 hours postdose||82.30|48.28|
71653694|NCT03465436|142825023|SUPERIORITY||LS Mean|52.85|||||TWO_SIDED|90.0|36.1|69.6|||Mixed Models Analysis|||4 hours postdose||69.60|36.10|
71653695|NCT03465436|142825023|SUPERIORITY||LS Mean|86.09|||||TWO_SIDED|90.0|66.36|105.82|||Mixed Models Analysis|||6 hours postdose||105.82|66.36|
71653696|NCT03465436|142825023|SUPERIORITY||LS Mean|80.12|||||TWO_SIDED|90.0|58.32|101.91|||Mixed Models Analysis|||8 hours postdose||101.91|58.32|
71653697|NCT03465436|142825023|SUPERIORITY||LS Mean|67.58|||||TWO_SIDED|90.0|44.64|90.51|||Mixed Models Analysis|||12 hours postdose||90.51|44.64|
71653698|NCT03465436|142825023|SUPERIORITY||LS Mean|7.77|||||TWO_SIDED|90.0|-10.01|25.55|||Mixed Models Analysis|||24 hours postdose||25.55|-10.01|
71653699|NCT03465436|142825023|SUPERIORITY||LS Mean|-22.02|||||TWO_SIDED|90.0|-38.44|-5.6|||Mixed Models Analysis|||30 minutes postdose||-5.60|-38.44|
71653700|NCT03465436|142825023|SUPERIORITY||LS Mean|-38.87|||||TWO_SIDED|90.0|-57.15|-20.6|||Mixed Models Analysis|||1 hour postdose||-20.60|-57.15|
71653701|NCT03465436|142825023|SUPERIORITY||LS Mean|-22.13|||||TWO_SIDED|90.0|-39.35|-4.91|||Mixed Models Analysis|||1.5 hours postdose||-4.91|-39.35|
71653702|NCT03465436|142825023|SUPERIORITY||LS Mean|-17.35|||||TWO_SIDED|90.0|-32.15|-2.56|||Mixed Models Analysis|||2 hours postdose||-2.56|-32.15|
71653703|NCT03465436|142825023|SUPERIORITY||LS Mean|-1.03|||||TWO_SIDED|90.0|-18.17|16.12|||Mixed Models Analysis|||2.5 hours postdose||16.12|-18.17|
71653704|NCT03465436|142825023|SUPERIORITY||LS Mean|-4.77|||||TWO_SIDED|90.0|-21.81|12.27|||Mixed Models Analysis|||3 hours postdose||12.27|-21.81|
71653705|NCT03465436|142825023|SUPERIORITY||LS Mean|-16.56|||||TWO_SIDED|90.0|-33.36|0.24|||Mixed Models Analysis|||3.5 hours postdose||0.24|-33.36|
71653706|NCT03465436|142825023|SUPERIORITY||LS Mean|-15.29|||||TWO_SIDED|90.0|-32.94|2.37|||Mixed Models Analysis|||4 hours postdose||2.37|-32.94|
71653707|NCT03465436|142825023|SUPERIORITY||LS Mean|6.13|||||TWO_SIDED|90.0|-10.86|23.11|||Mixed Models Analysis|||6 hours postdose||23.11|-10.86|
71653708|NCT03465436|142825023|SUPERIORITY||LS Mean|2.27|||||TWO_SIDED|90.0|-15.25|19.8|||Mixed Models Analysis|||8 hours postdose||19.80|-15.25|
71653709|NCT03465436|142825023|SUPERIORITY||LS Mean|-11.95|||||TWO_SIDED|90.0|-33.46|9.56|||Mixed Models Analysis|||12 hours postdose||9.56|-33.46|
71653710|NCT03465436|142825023|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-17.32|16.69|||Mixed Models Analysis|||24 hours postdose||16.69|-17.32|
71653711|NCT03465436|142825024|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.37|0.41|||Mixed Models Analysis|||30 minutes postdose||0.41|-0.37|
71653712|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.23|||||TWO_SIDED|90.0|-0.61|0.15|||Mixed Models Analysis|||1 hour postdose||0.15|-0.61|
71653713|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-0.47|0.23|||Mixed Models Analysis|||1.5 hours postdose||0.23|-0.47|
71653714|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.44|||||TWO_SIDED|90.0|-0.81|-0.07|||Mixed Models Analysis|||2 hours postdose||-0.07|-0.81|
71653715|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-0.95|-0.15|||Mixed Models Analysis|||2.5 hours postdose||-0.15|-0.95|
71653716|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.77|0.0|||Mixed Models Analysis|||3 hours postdose||0.00|-0.77|
71653717|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.41|||||TWO_SIDED|90.0|-0.72|-0.1|||Mixed Models Analysis|||3.5 hours postdose||-0.10|-0.72|
71653718|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.35|||||TWO_SIDED|90.0|-0.66|-0.04|||Mixed Models Analysis|||4 hours postdose||-0.04|-0.66|
71653719|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.54|||||TWO_SIDED|90.0|-0.98|-0.09|||Mixed Models Analysis|||6 hours postdose||-0.09|-0.98|
71653720|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.14|||||TWO_SIDED|90.0|-0.58|0.31|||Mixed Models Analysis|||8 hours postdose||0.31|-0.58|
71653721|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.29|||||TWO_SIDED|90.0|-0.7|0.12|||Mixed Models Analysis|||12 hours postdose||0.12|-0.70|
71653722|NCT03465436|142825024|SUPERIORITY||LS Mean|0.43|||||TWO_SIDED|90.0|0.01|0.84|||Mixed Models Analysis|||24 hours postdose||0.84|0.01|
71653723|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.19|||||TWO_SIDED|90.0|-0.59|0.21|||Mixed Models Analysis|||30 minutes postdose||0.21|-0.59|
71653724|NCT03465436|142825024|SUPERIORITY||LS Mean|0.48|||||TWO_SIDED|90.0|0.06|0.89|||Mixed Models Analysis|||1 hour postdose||0.89|0.06|
71653725|NCT03465436|142825024|SUPERIORITY||LS Mean|0.56|||||TWO_SIDED|90.0|0.19|0.93|||Mixed Models Analysis|||1.5 hours postdose||0.93|0.19|
71705754|NCT05894564|142929597|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.27|0.81|
71705755|NCT05894564|142929597|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.18|0.76|
71705756|NCT05894564|142929597|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.72|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.72|
71705757|NCT05894564|142929597|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.79|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.79|
71653726|NCT03465436|142825024|SUPERIORITY||LS Mean|0.4|||||TWO_SIDED|90.0|0.02|0.77|||Mixed Models Analysis|||2 hours postdose||0.77|0.02|
71653727|NCT03465436|142825024|SUPERIORITY||LS Mean|0.51|||||TWO_SIDED|90.0|0.13|0.88|||Mixed Models Analysis|||2.5 hours postdose||0.88|0.13|
71653728|NCT03465436|142825024|SUPERIORITY||LS Mean|0.33|||||TWO_SIDED|90.0|-0.05|0.71|||Mixed Models Analysis|||3 hours postdose||0.71|-0.05|
71653729|NCT03465436|142825024|SUPERIORITY||LS Mean|0.32|||||TWO_SIDED|90.0|-0.02|0.67|||Mixed Models Analysis|||3.5 hours postdose||0.67|-0.02|
71653730|NCT03465436|142825024|SUPERIORITY||LS Mean|0.5|||||TWO_SIDED|90.0|0.16|0.84|||Mixed Models Analysis|||4 hours postdose||0.84|0.16|
71653731|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.56|0.36|||Mixed Models Analysis|||6 hours postdose||0.36|-0.56|
71653732|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.11|||||TWO_SIDED|90.0|-0.56|0.33|||Mixed Models Analysis|||8 hours postdose||0.33|-0.56|
71653733|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.84|0.06|||Mixed Models Analysis|||12 hours postdose||0.06|-0.84|
71653734|NCT03465436|142825024|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|90.0|-0.37|0.45|||Mixed Models Analysis|||24 hours postdose||0.45|-0.37|
71653735|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.45|0.28|||Mixed Models Analysis|||30 minutes postdose||0.28|-0.45|
71653736|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.1|||||TWO_SIDED|90.0|-0.46|0.27|||Mixed Models Analysis|||1 hour postdose||0.27|-0.46|
71653737|NCT03465436|142825024|SUPERIORITY||LS Mean|0.25|||||TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis|||1.5 hours postdose||0.60|-0.10|
71653738|NCT03465436|142825024|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|90.0|-0.38|0.4|||Mixed Models Analysis|||2 hours postdose||0.40|-0.38|
71653739|NCT03465436|142825024|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|90.0|-0.34|0.37|||Mixed Models Analysis|||2.5 hours postdose||0.37|-0.34|
71653740|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.09|||||TWO_SIDED|90.0|-0.44|0.25|||Mixed Models Analysis|||3 hours postdose||0.25|-0.44|
71653741|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.76|-0.03|||Mixed Models Analysis|||3.5 hours postdose||-0.03|-0.76|
71653742|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.38|||||TWO_SIDED|90.0|-0.73|-0.03|||Mixed Models Analysis|||4 hours postdose||-0.03|-0.73|
71653743|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.6|||||TWO_SIDED|90.0|-1.03|-0.17|||Mixed Models Analysis|||6 hours postdose||-0.17|-1.03|
71653744|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.39|||||TWO_SIDED|90.0|-0.82|0.04|||Mixed Models Analysis|||8 hours postdose||0.04|-0.82|
71653745|NCT03465436|142825024|SUPERIORITY||LS Mean|-0.31|||||TWO_SIDED|90.0|-0.7|0.09|||Mixed Models Analysis|||12 hours postdose||0.09|-0.70|
71653746|NCT03465436|142825024|SUPERIORITY||LS Mean|0.19|||||TWO_SIDED|90.0|-0.23|0.61|||Mixed Models Analysis|||24 hours postdose||0.61|-0.23|
71653747|NCT03465436|142825025|SUPERIORITY||LS Mean|-1.53|||||TWO_SIDED|90.0|-2.9|-0.16|||Mixed Models Analysis|||30 minutes postdose||-0.16|-2.90|
71653748|NCT03465436|142825025|SUPERIORITY||LS Mean|-5.09|||||TWO_SIDED|90.0|-6.29|-3.88|||Mixed Models Analysis|||1 hour postdose||-3.88|-6.29|
71653749|NCT03465436|142825025|SUPERIORITY||LS Mean|-5.57|||||TWO_SIDED|90.0|-6.81|-4.32|||Mixed Models Analysis|||1.5 hours postdose||-4.32|-6.81|
71653750|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.01|||||TWO_SIDED|90.0|-5.0|-3.01|||Mixed Models Analysis|||2 hours postdose||-3.01|-5.00|
71653751|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.78|||||TWO_SIDED|90.0|-5.91|-3.65|||Mixed Models Analysis|||2.5 hours postdose||-3.65|-5.91|
71653752|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.14|||||TWO_SIDED|90.0|-5.2|-3.08|||Mixed Models Analysis|||3 hours postdose||-3.08|-5.20|
71653753|NCT03465436|142825025|SUPERIORITY||LS Mean|-2.94|||||TWO_SIDED|90.0|-3.87|-2.01|||Mixed Models Analysis|||3.5 hours postdose||-2.01|-3.87|
71653754|NCT03465436|142825025|SUPERIORITY||LS Mean|-2.42|||||TWO_SIDED|90.0|-3.42|-1.42|||Mixed Models Analysis|||4 hours postdose||-1.42|-3.42|
71653755|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.61|||||TWO_SIDED|90.0|-6.17|-3.06|||Mixed Models Analysis|||6 hours postdose||-3.06|-6.17|
71653756|NCT03465436|142825025|SUPERIORITY||LS Mean|-3.82|||||TWO_SIDED|90.0|-5.38|-2.26|||Mixed Models Analysis|||8 hours postdose||-2.26|-5.38|
71653757|NCT03465436|142825025|SUPERIORITY||LS Mean|-2.65|||||TWO_SIDED|90.0|-4.33|-0.97|||Mixed Models Analysis|||12 hours postdose||-0.97|-4.33|
71653758|NCT03465436|142825025|SUPERIORITY||LS Mean|0.12|||||TWO_SIDED|90.0|-1.22|1.46|||Mixed Models Analysis|||24 hours postdose||1.46|-1.22|
71653759|NCT03465436|142825025|SUPERIORITY||LS Mean|-3.09|||||TWO_SIDED|90.0|-4.16|-2.02|||Mixed Models Analysis|||30 minutes postdose||-2.02|-4.16|
71653760|NCT03465436|142825025|SUPERIORITY||LS Mean|-5.61|||||TWO_SIDED|90.0|-6.65|-4.58|||Mixed Models Analysis|||1 hour postdose||-4.58|-6.65|
71653761|NCT03465436|142825025|SUPERIORITY||LS Mean|-5.39|||||TWO_SIDED|90.0|-6.42|-4.35|||Mixed Models Analysis|||1.5 hours postdose||-4.35|-6.42|
71653762|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.64|||||TWO_SIDED|90.0|-5.55|-3.72|||Mixed Models Analysis|||2 hours postdose||-3.72|-5.55|
71653763|NCT03465436|142825025|SUPERIORITY||LS Mean|-5.82|||||TWO_SIDED|90.0|-6.77|-4.87|||Mixed Models Analysis|||2.5 hours postdose||-4.87|-6.77|
71653764|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.99|||||TWO_SIDED|90.0|-6.03|-3.96|||Mixed Models Analysis|||3 hours postdose||-3.96|-6.03|
71653765|NCT03465436|142825025|SUPERIORITY||LS Mean|-3.69|||||TWO_SIDED|90.0|-4.68|-2.71|||Mixed Models Analysis|||3.5 hours postdose||-2.71|-4.68|
71653766|NCT03465436|142825025|SUPERIORITY||LS Mean|-3.19|||||TWO_SIDED|90.0|-4.21|-2.17|||Mixed Models Analysis|||4 hours postdose||-2.17|-4.21|
71653767|NCT03465436|142825025|SUPERIORITY||LS Mean|-6.29|||||TWO_SIDED|90.0|-7.83|-4.95|||Mixed Models Analysis|||6 hours postdose||-4.95|-7.83|
71653768|NCT03465436|142825025|SUPERIORITY||LS Mean|-5.37|||||TWO_SIDED|90.0|-6.73|-4.02|||Mixed Models Analysis|||8 hours postdose||-4.02|-6.73|
71653769|NCT03465436|142825025|SUPERIORITY||LS Mean|-4.71|||||TWO_SIDED|90.0|-6.25|-3.17|||Mixed Models Analysis|||12 hours postdose||-3.17|-6.25|
71653770|NCT03465436|142825025|SUPERIORITY||LS Mean|-0.55|||||TWO_SIDED|90.0|-1.74|0.63|||Mixed Models Analysis|||24 hours postdose||0.63|-1.74|
71653771|NCT03465436|142825025|SUPERIORITY||LS Mean|1.32|||||TWO_SIDED|90.0|0.32|2.33|||Mixed Models Analysis|||30 minutes postdose||2.33|0.32|
71653772|NCT03465436|142825025|SUPERIORITY||LS Mean|2.29|||||TWO_SIDED|90.0|1.19|3.4|||Mixed Models Analysis|||1 hour postdose||3.40|1.19|
71653773|NCT03465436|142825025|SUPERIORITY||LS Mean|1.3|||||TWO_SIDED|90.0|0.31|2.28|||Mixed Models Analysis|||1.5 hours postdose||2.28|0.31|
71653774|NCT03465436|142825025|SUPERIORITY||LS Mean|1.07|||||TWO_SIDED|90.0|0.17|1.97|||Mixed Models Analysis|||2 hours postdose||1.97|0.17|
71653775|NCT03465436|142825025|SUPERIORITY||LS Mean|0.21|||||TWO_SIDED|90.0|-0.81|1.23|||Mixed Models Analysis|||2.5 hours postdose||1.23|-0.81|
71653776|NCT03465436|142825025|SUPERIORITY||LS Mean|0.53|||||TWO_SIDED|90.0|-0.5|1.56|||Mixed Models Analysis|||3 hours postdose||1.56|-0.50|
71653777|NCT03465436|142825025|SUPERIORITY||LS Mean|1.36|||||TWO_SIDED|90.0|0.29|2.44|||Mixed Models Analysis|||3.5 hours postdose||2.44|0.29|
71653778|NCT03465436|142825025|SUPERIORITY||LS Mean|1.21|||||TWO_SIDED|90.0|0.09|2.34|||Mixed Models Analysis|||4 hours postdose||2.34|0.09|
71653779|NCT03465436|142825025|SUPERIORITY||LS Mean|-0.49|||||TWO_SIDED|90.0|-1.97|0.99|||Mixed Models Analysis|||6 hours postdose||0.99|-1.97|
71653780|NCT03465436|142825025|SUPERIORITY||LS Mean|-0.36|||||TWO_SIDED|90.0|-1.54|0.83|||Mixed Models Analysis|||8 hours postdose||0.83|-1.54|
71653781|NCT03465436|142825025|SUPERIORITY||LS Mean|0.73|||||TWO_SIDED|90.0|-0.87|2.34|||Mixed Models Analysis|||12 hours postdose||2.34|-0.87|
71653782|NCT03465436|142825025|SUPERIORITY||LS Mean|-0.12|||||TWO_SIDED|90.0|-1.29|1.04|||Mixed Models Analysis|||24 hours postdose||1.04|-1.29|
71653783|NCT02697773|142825029|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0129|TWO_SIDED|95.0|-1.07|-0.13||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.13|-1.07|0.0129
71653784|NCT02697773|142825029|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0023|TWO_SIDED|95.0|-1.2|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.26|-1.20|0.0023
71653785|NCT02697773|142825030|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.24||0.0065|TWO_SIDED|95.0|-1.14|-0.19||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-1.14|0.0065
71705758|NCT05894564|142929597|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.64|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.01|0.64|
71764164|NCT01086358|143029915|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.059|TWO_SIDED|95.0|-1.39|0.03|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order.||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.||0.03|-1.39|0.059
71764165|NCT01086358|143029916|SUPERIORITY||Odds Ratio (OR)|2.89||||0.016|TWO_SIDED|95.0|1.22|6.84|||Regression, Logistic|As noted above, results are adjusted for study period and treatment order.||Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..||6.84|1.22|0.016
71764166|NCT04975230|143029917|OTHER||Cohen's D|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.0227|TWO_SIDED|95.0|-0.37|0.78|||Mixed Models Analysis|||||0.78|-0.37|0.0227
71764167|NCT02471612|143029925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||Comparing the sensitivity of APACHE-II and P-POSSUM|McNemar|||"Area under the curve (AUC) is used to measure the size of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value \> 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value \< 0.60 is regarded as poor."||||0.665
71764168|NCT00984620|143029966|SUPERIORITY_OR_OTHER||Adjusted percent difference|-1.25||||0.855|TWO_SIDED|95.0|-14.3|11.8|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||11.8|-14.3|0.855
71764169|NCT00984620|143029967|SUPERIORITY_OR_OTHER||Adjusted percent difference|9.02||||0.229|TWO_SIDED|95.0|-5.3|23.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||23.3|-5.3|0.229
71764170|NCT00984620|143029968|SUPERIORITY_OR_OTHER||Adjusted percent difference|5.48||||0.417|TWO_SIDED|95.0|-7.3|18.3|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.3|-7.3|0.417
71764171|NCT00984620|143029969|SUPERIORITY_OR_OTHER||Adjusted percent difference|2.99||||0.676|TWO_SIDED|95.0|-10.6|16.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||16.6|-10.6|0.676
71764172|NCT00984620|143029970|SUPERIORITY_OR_OTHER||Adjusted percent difference|3.24||||0.588|TWO_SIDED|95.0|-8.1|14.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||14.6|-8.1|0.588
71764173|NCT00984620|143029971|SUPERIORITY_OR_OTHER||Adjusted percent difference|4.78||||0.512|TWO_SIDED|95.0|-9.0|18.6|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).|p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).|||18.6|-9.0|0.512
71764174|NCT00984620|143029973|SUPERIORITY_OR_OTHER|||||||0.1397||||||Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test.|Log Rank|||||||0.1397
71764175|NCT00470834|143030008|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Log Rank|||||||0.79
71764176|NCT00470834|143030008|SUPERIORITY_OR_OTHER||Relative Risk|0.94|||||TWO_SIDED|95.0|0.61|1.46|||||The hazard ratio is based on the Cox proportional hazards model.|||1.46|0.61|
71764177|NCT00470834|143030008|SUPERIORITY_OR_OTHER||Relative Risk Reduction|5.62|||||TWO_SIDED|95.0|-46.14|39.05|||||Relative Risk Reduction = 100 \* (1 - Relative Risk).|||39.05|-46.14|
71764178|NCT00244140|143030013|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR1|95.8||||||95.0|93.3|97.6||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||97.6|93.3|
71764179|NCT00244140|143030013|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR2|96.3||||||95.0|93.9|98.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||98.0|93.9|
71764180|NCT00244140|143030013|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent: BR3|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||99.4|96.6|
71764181|NCT00244140|143030014|SUPERIORITY_OR_OTHER||Percent Images Rated Yes|99.7||||||95.0|98.6|100.0||||||||100.0|98.6|
71764182|NCT00244140|143030015|SUPERIORITY_OR_OTHER||Percent Images Rated Good/Excellent|99.5||||||95.0|98.1|99.9||||||||99.9|98.1|
71764183|NCT00244140|143030016|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR1|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).||99.4|96.6|
71764184|NCT00244140|143030016|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR2|100.0||||||95.0|99.0|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).||100.0|99.0|
71764185|NCT00244140|143030016|SUPERIORITY_OR_OTHER||Percent Images Rated Yes: BR3|99.7||||||95.0|98.6|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).||100.0|98.6|
71825856|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|637.67|||<|0.0001|TWO_SIDED|95.0|330.3|945.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||945.03|330.30|<0.0001
71825857|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1813.29|||<|0.0001|TWO_SIDED|95.0|1503.03|2123.54||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2123.54|1503.03|<0.0001
71825858|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|589.61||||0.0002|TWO_SIDED|95.0|285.31|893.92|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||893.92|285.31|0.0002
71825859|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|651.57|||<|0.0001|TWO_SIDED|95.0|346.44|956.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||956.70|346.44|<0.0001
71825860|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1827.19|||<|0.0001|TWO_SIDED|95.0|1519.78|2134.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||2134.60|1519.78|<0.0001
71825861|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|61.96||||0.6874|TWO_SIDED|95.0|-241.25|365.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||365.17|-241.25|0.6874
71825862|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1237.58|||<|0.0001|TWO_SIDED|95.0|931.46|1543.7|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1543.70|931.46|<0.0001
71825863|NCT00708097|143156292|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1175.62|||<|0.0001|TWO_SIDED|95.0|869.15|1482.1||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.||1482.10|869.15|<0.0001
71825864|NCT01677936|143156293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||=|0.024||||||Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.024
71825865|NCT01677936|143156294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||=|0.035||||||Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.|t-test, 2 sided|||||||=0.035
71825866|NCT00157014|143156320|SUPERIORITY_OR_OTHER|||||||0.4725||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.4725
71825867|NCT00157014|143156331|SUPERIORITY_OR_OTHER|||||||0.8373||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)|||||||0.8373
71705759|NCT05894564|142929598|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.17|||||TWO_SIDED|95.0|-0.56|0.26|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.26|-0.56|
71705760|NCT05894564|142929599|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.21|||||TWO_SIDED|95.0|-0.29|0.68|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.68|-0.29|
71705761|NCT03882801|142929600|SUPERIORITY||Least Square Geometric Means Ratio|0.92|||||TWO_SIDED|90.0|0.73|1.17|||||Back transformed least squares mean and confidence interval from linear mixed effects model performed on natural log-transformed values.|||1.17|0.73|
71705762|NCT03548415|142929613|SUPERIORITY|||||||0.306||||||The p-value was analyzed using the nonparametric test, Van Elteren test with IGF-1 level as stratification factor.|Van Elteren test|||||||0.306
71705763|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 18 to 34||0.01|0.01|
71705764|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.01|||||TWO_SIDED|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 35 to 44||0.01|0.01|
71825868|NCT03686813|143156350|OTHER|||||||0.317|||||||McNemar|||||||0.317
71825869|NCT03686813|143156351|OTHER|||||||0.317|||||||McNemar|||||||0.317
71653786|NCT02697773|142825030|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.37|-0.42||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.42|-1.37|0.0002
71653787|NCT02697773|142825031|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0109|TWO_SIDED|95.0|-0.39|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.39|0.0109
71653788|NCT02697773|142825031|SUPERIORITY|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0038|TWO_SIDED|95.0|-0.41|-0.08||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.41|0.0038
71653789|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.08|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.08|0.0020
71653790|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.1|-0.26|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.10|0.0014
71705765|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.03|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 45 to 54||0.04|0.03|
71705766|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.07|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 55 to 64||0.09|0.07|
71705767|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.11|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 65 to 74||0.14|0.11|
71705768|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.18|||||TWO_SIDED|95.0|0.15|0.21|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age ≥75||0.21|0.15|
71705769|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.09|||||TWO_SIDED|95.0|0.06|0.13|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 18 to 34||0.13|0.06|
71705770|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.11|||||TWO_SIDED|95.0|0.08|0.16|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 35 to 44||0.16|0.08|
71705771|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.3|0.45|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 45 to 54||0.45|0.30|
71705772|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.83|||||TWO_SIDED|95.0|2.68|5.47|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 65 to 74||5.47|2.68|
71825870|NCT03686813|143156352|OTHER||||||>|0.999|||||||McNemar|||||||>0.999
71825871|NCT03686813|143156353|OTHER|||||||0.18|||||||McNemar|||||||0.18
71825872|NCT03686813|143156354|OTHER|||||||0.29|||||||McNemar|||||||0.29
71825873|NCT02175212|143156355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.88||||0.01|TWO_SIDED|95.0|1.12|3.15|||Regression, Cox|||||3.15|1.12|0.01
71825874|NCT02175212|143156356|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.31||||0.01|TWO_SIDED|95.0|1.23|3.85|||Regression, Cox|||||3.85|1.23|0.01
71825875|NCT02175212|143156357|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.48||||0.009|TWO_SIDED|95.0|1.31|4.68|||Regression, Cox|||||4.68|1.31|0.009
71825876|NCT00606580|143156413|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||0.0001
71705773|NCT01260324|142929637|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.73|||||TWO_SIDED|95.0|4.0|8.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age ≥75||8.22|4.00|
71705774|NCT01260324|142929638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Female||0.05|0.04|
71705775|NCT01260324|142929638|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Male||0.06|0.05|
71705776|NCT01260324|142929638|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.5|2.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Male||2.22|1.50|
71705777|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2003||0.05|0.04|
71764186|NCT05408637|143030017|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between stimulation (Active vs Sham).|Mean Difference (Final Values)|54.75|||||TWO_SIDED||||||||Difference = Active - Sham|||||
71764187|NCT05408637|143030017|OTHER||Percent Difference|0.85|||||TWO_SIDED||||||||Difference = Active - Sham|The small sample size did not allow for statistical tests. Therefore, we looked at percent difference between stimulation (Active vs Sham).||||
71764188|NCT05408637|143030017|OTHER||Cohen's d|0.07|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between Active and Sham using Cohen's d.||||
71825877|NCT00606580|143156413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.||||<0.0001
71825878|NCT00606580|143156413|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.871|||||||Chi-squared|||H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||0.871
71705778|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2004||0.05|0.04|
71705779|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2005||0.05|0.04|
71705780|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2006||0.05|0.04|
71705781|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2007||0.05|0.04|
71705782|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2004||0.96|0.61|
71705783|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2005||0.91|0.58|
71705784|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2006||1.12|0.68|
71705785|NCT01260324|142929639|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.19|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2007||1.19|0.72|
71705786|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Northeast||0.06|0.04|
71764189|NCT05408637|143030018|OTHER|The small sample size did not allow for statistical tests. Therefore, we looked at overall patterns and calculated differences between active stimulation timepoints (Day 1 vs Day 5).|Mean Difference (Final Values)|224.8392|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|||||
71764190|NCT05408637|143030018|OTHER||Percent Difference|4.35|||||TWO_SIDED||||||||Difference = Day 5 Active - Day 1 Active|The small sample size did not allow for statistical tests. Therefore, we calculated percent difference between active stimulation timepoints (Day 1 vs Day 5).||||
71764191|NCT05408637|143030018|OTHER||Cohen's d|0.36|||||TWO_SIDED|||||||||We evaluated the effect size of the difference between active stimulation timepoints (Day 1 vs Day 5) using Cohen's d.||||
71764192|NCT05408637|143030019|OTHER||rank biserial correlation coefficient|0.767||||0.15|TWO_SIDED||||||Wilcoxon signed rank test|||The Wilcoxon signed-rank test was used to evaluate changes in the IGT at Baseline vs Day 5 due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.||||0.15
71764193|NCT05408637|143030019|OTHER|The Friedman test was used to assess overall differences in IGT across Baseline, Day 1, and Day 5.||||||0.038|||||||Friedman test|||||||0.038
71764194|NCT05408637|143030019|OTHER|The Friedman test was used to assess overall differences in IGT across all timepoints (Baseline, Day 1, Day 5, Follow-Up).||||||0.043|||||||Friedman test|||||||0.043
71764195|NCT05408637|143030019|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BIS across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.134||||0.42|TWO_SIDED||||||Wilcoxon signed rank test|BIS across timepoints||||||0.42
71705787|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Midwest||0.05|0.04|
71705788|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate South||0.06|0.05|
71705789|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate West||0.05|0.04|
71705790|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.31|0.56|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Northeast||0.56|0.31|
71705791|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68|||||TWO_SIDED|95.0|0.56|0.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Midwest||0.84|0.56|
71705792|NCT01260324|142929640|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.57|0.93|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio West||0.93|0.57|
71705793|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diabetes||0.10|0.08|
71705794|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.11|||||TWO_SIDED|95.0|0.08|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Smoking||0.14|0.08|
71705795|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.04|||||TWO_SIDED|95.0|0.03|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Obesity||0.06|0.03|
71705796|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.06|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Nitrates||0.09|0.06|
71705797|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.15|||||TWO_SIDED|95.0|0.12|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Anti-platelet agents||0.18|0.12|
71705798|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.09|0.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diuretics||0.17|0.09|
71705799|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.03|||||TWO_SIDED|95.0|0.01|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent PDE-5 inhibitors use||0.04|0.01|
71705800|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|1.47|2.25|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diabetes||2.25|1.47|
71705801|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.63|2.85|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Smoking||2.85|0.63|
71705802|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.23|0.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Obesity||0.81|0.23|
71705803|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.42|0.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Nitrates||0.94|0.42|
71705804|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.53|2.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Anti-platelet agents||2.94|1.53|
71705805|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.46|3.43|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diuretics||3.43|1.46|
71705806|NCT01260324|142929641|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57|||||TWO_SIDED|95.0|0.31|1.04|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Recent PDE-5 inhibitors use||1.04|0.31|
71705807|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.33|||||TWO_SIDED|95.0|0.28|0.39|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other retinal disorders||0.39|0.28|
71705808|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.13|||||TWO_SIDED|95.0|0.11|0.16|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Glaucoma||0.16|0.11|
71705809|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.2|||||TWO_SIDED|95.0|0.08|0.41|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Cataract||0.41|0.08|
71705810|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.99|||||TWO_SIDED|95.0|0.83|1.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Visual disturbances||1.17|0.83|
71705811|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|2.0|||||TWO_SIDED|95.0|1.6|2.46|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Blindness and low vision||2.46|1.60|
71825879|NCT00606580|143156414|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||||||0.0006
71825880|NCT00606580|143156414|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Chi-squared|||||||0.0002
71825881|NCT00606580|143156414|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.767|||||||Chi-squared|||||||0.767
71705812|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.19|||||TWO_SIDED|95.0|0.16|0.23|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of eye||0.23|0.16|
71705813|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.22|||||TWO_SIDED|95.0|0.18|0.27|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Occlusion and stenosis of precerebral arteries||0.27|0.18|
71705814|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.07|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Acute sinusitis||0.08|0.05|
71825882|NCT00606580|143156415|SUPERIORITY_OR_OTHER|||||||0.33|||||||Log Rank|Mantel-Cox (log-rank) grouped failure time test using proportion re-epithelialized at each of the scheduled assessments through Day 42 without relapse||||||0.330
71764196|NCT05408637|143030019|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the BRIEF-A across timepoints due to the small sample size and distributional assumptions.||||||0.232|||||||Wilcoxon signed rank test|BRIEF-A across timepoints||||||0.232
71705815|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other dermatoses||0.08|0.05|
71705816|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.08|||||TWO_SIDED|95.0|0.06|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of bone and cartilage||0.10|0.06|
71705817|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.12|||||TWO_SIDED|95.0|0.1|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Symptoms involving head and neck||0.14|0.10|
71705818|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.14|||||TWO_SIDED|95.0|0.1|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other ill defined and unknown causes of morbidity and mortality||0.18|0.10|
71705819|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.65|||||TWO_SIDED|95.0|4.72|9.38|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other retinal disorders||9.38|4.72|
71705820|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.77|3.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Glaucoma||3.81|1.77|
71825883|NCT00606580|143156415|SUPERIORITY_OR_OTHER|||||||0.275|||||||Log Rank|||||||0.275
71705821|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|1.02|1.68|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Cataract||1.68|1.02|
71825884|NCT00606580|143156415|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.83|||||||Log Rank|||||||0.830
71705822|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|14.2|||||TWO_SIDED|95.0|10.4|19.3|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Visual disturbances||19.30|10.40|
71705823|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.1|||||TWO_SIDED|95.0|6.6|34.5|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Blindness and low vision||34.50|6.60|
71825885|NCT00606580|143156420|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||0.0001
71705824|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02|||||TWO_SIDED|95.0|1.44|2.82|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of eye||2.82|1.44|
71705825|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.64|2.31|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Occlusion and stenosis of precerebral arteries||2.31|0.64|
71705826|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.96|1.74|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Acute sinusitis||1.74|0.96|
71705827|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|1.02|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other dermatoses||1.77|1.02|
71764197|NCT05408637|143030019|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Impulsivity across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.575||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|i7 Impulsivity||||||0.06
71764198|NCT05408637|143030019|OTHER|The Wilcoxon signed-rank test was used to evaluate changes in the i7 Venturesomeness across timepoints due to the small sample size and distributional assumptions. Effect sizes were calculated using the rank biserial correlation coefficient (r) to estimate the magnitude of change.|rank biserial correlation coefficient|0.275||||0.36|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.36
71825886|NCT00606580|143156420|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71825887|NCT00606580|143156420|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.725|||||||Chi-squared|||||||0.725
71825888|NCT00606580|143156421|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
71825889|NCT00606580|143156421|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
71825890|NCT00606580|143156421|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||1|||||||Chi-squared|||||||1.000
71653791|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.31|-0.45|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.45|-1.31|<.0001
71653792|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.3|-0.44|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.44|-1.30|<.0001
71653793|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0085|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.15|-1.03|0.0085
71653794|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0657|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0657
71653795|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.24||0.0012|TWO_SIDED|95.0|-1.25|-0.31|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.31|-1.25|0.0012
71653796|NCT02697773|142825032|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
71653797|NCT02697773|142825034|SUPERIORITY||Least Mean Square Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.17|-0.34|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.17|0.0004
71653798|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.50|-1.33|<.0001
71653799|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.45|-0.6|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.60|-1.45|<.0001
71653800|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.53|-0.68|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.68|-1.53|<.0001
71653801|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0057|TWO_SIDED|95.0|-1.07|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.18|-1.07|0.0057
71705828|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of bone and cartilage||1.77|0.98|
71705829|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.02|1.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Symptoms involving head and neck||1.84|1.02|
71825891|NCT00606580|143156422|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
71825892|NCT00606580|143156422|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71825893|NCT00606580|143156422|NON_INFERIORITY_OR_EQUIVALENCE|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.893|||||||Chi-squared|||||||0.893
71825894|NCT00606580|143156423|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71653802|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.0114|TWO_SIDED|95.0|-1.02|-0.13|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.13|-1.02|0.0114
71653803|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.24||0.0004|TWO_SIDED|95.0|-1.33|-0.38|||ANCOVA|||Week 12:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.38|-1.33|0.0004
71653804|NCT02697773|142825034|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.52|-0.58|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.||-0.58|-1.52|<.0001
71653805|NCT02697773|142825036|SUPERIORITY||Least Mean Square Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0236|TWO_SIDED|95.0|-0.32|-0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.02|-0.32|0.0236
71653806|NCT02697773|142825036|SUPERIORITY||Least Square Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0958|TWO_SIDED|95.0|-0.27|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.||0.02|-0.27|0.0958
71653807|NCT02697773|142825036|SUPERIORITY||Least Square Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07||0.0007|TWO_SIDED|95.0|-0.4|-0.11|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.40|0.0007
71653808|NCT02697773|142825036|SUPERIORITY||Least Mean Square Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.36|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.07|-0.36|0.0040
71705830|NCT01260324|142929642|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.08|2.49|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Ill defined and unknown causes of morbidity and mortality||2.49|1.08|
71705831|NCT01260324|142929643|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.07|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent use||0.07|0.03|
71705832|NCT01260324|142929643|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.04|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Any use (includes chronic and non-chronic use)||0.08|0.04|
71705833|NCT01260324|142929643|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.05|||||TWO_SIDED|95.0|0.03|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Chronic use||0.08|0.03|
71705834|NCT01260324|142929643|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.06|||||TWO_SIDED|95.0|0.03|0.11|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Non-chronic use||0.11|0.03|
71705835|NCT01260324|142929643|SUPERIORITY_OR_OTHER_LEGACY||Incidence rate per 1000 person-years|0.09|||||TWO_SIDED|95.0|0.08|0.1|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Never use||0.10|0.08|
71705836|NCT00004228|142929647|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 (A: CCG BFM) to regimens B1+B2 (B: NHL/BFM-95) while adjusting for the other intervention through stratification."||||.97
71705837|NCT00004228|142929647|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Cox|||"A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 (1: no intensification) to A2 +B2 (2: intensification), while adjusting for the other intervention through stratification."||||.63
71705838|NCT01292473|142929655|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69||||0.4637|TWO_SIDED|95.0|-2.54|1.16||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.16|-2.54|0.4637
71705839|NCT01292473|142929655|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.04||||0.0011|TWO_SIDED|95.0|-4.85|-1.24||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.24|-4.85|0.0011
71825895|NCT00606580|143156423|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71825896|NCT00606580|143156423|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.247|||||||Chi-squared|||||||0.247
71825897|NCT00606580|143156424|SUPERIORITY_OR_OTHER|||||||0.409|||||||Chi-squared|||||||0.409
71825898|NCT00606580|143156424|SUPERIORITY_OR_OTHER|||||||0.651|||||||Chi-squared|||||||0.651
71825899|NCT00606580|143156424|NON_INFERIORITY_OR_EQUIVALENCE|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p \< .05.||||||0.701|||||||Chi-squared|||||||0.701
71653809|NCT02697773|142825036|SUPERIORITY||Least Square Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.0498|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.00|-0.31|0.0498
71653810|NCT02697773|142825036|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.238|TWO_SIDED|95.0|-0.24|0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||0.06|-0.24|0.2380
71653811|NCT02697773|142825036|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.0426|TWO_SIDED|95.0|-0.34|-0.01|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.01|-0.34|0.0426
71653812|NCT02697773|142825036|SUPERIORITY||Least Square Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.09||0.0014|TWO_SIDED|95.0|-0.45|-0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.||-0.11|-0.45|0.0014
71653813|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0027|TWO_SIDED|95.0|1.22|2.61|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.61|1.22|0.0027
71653814|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0004|TWO_SIDED|95.0|1.36|2.89|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.89|1.36|0.0004
71653815|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0008|TWO_SIDED|95.0|1.33|2.95|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.95|1.33|0.0008
71653816|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.37|3.04|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.37|0.0004
71653817|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.27||||0.2283|TWO_SIDED|95.0|0.86|1.87|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.87|0.86|0.2283
71653818|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|0.93|2.03|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.03|0.93|0.1066
71653819|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0154|TWO_SIDED|95.0|1.1|2.54|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.54|1.10|0.0154
71825900|NCT00667693|143156455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.55|||Regression, Cox|||||0.55|0.23|<0.001
71653820|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0006|TWO_SIDED|95.0|1.38|3.27|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|1.38|0.0006
71653821|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1139|TWO_SIDED|95.0|0.92|2.07|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.07|0.92|0.1139
71653822|NCT02697773|142825038|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0014|TWO_SIDED|95.0|1.31|3.04|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.31|0.0014
71825901|NCT02020018|143156460|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
71825902|NCT04044664|143156463|OTHER|||||||0.1728|||||||t-test, 1 sided|||CAPS-5 Total Score||||0.1728
71825903|NCT04044664|143156463|OTHER|||||||0.0962|||||||t-test, 1 sided|||Cognition and Mood sub-score||||0.0962
71825904|NCT04044664|143156463|OTHER|||||||0.0191|||||||t-test, 1 sided|||Arousal and Reactivity sub-score||||0.0191
71825905|NCT04044664|143156469|OTHER|||||||0.0452|||||||t-test, 1 sided|||||||0.0452
71764199|NCT05408637|143030020|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Day 5 due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.12||||0.6|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.6
71764200|NCT05408637|143030020|OTHER|Non-parametric tests were employed to evaluate changes across MOODS-SR Baseline to Follow Up due to the small sample size and distributional assumptions. The Wilcoxon signed-rank tests were applied for pairwise comparisons. Effect sizes were calculated using Cohen's d to estimate the magnitude of change.|Cohen's d|0.24||||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||||||0.2
71764201|NCT02693132|143030034|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71764202|NCT02693132|143030035|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71764203|NCT02693132|143030036|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71705840|NCT01292473|142929655|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.81|||<|0.0001|TWO_SIDED|95.0|-6.49|-3.13||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-3.13|-6.49|<0.0001
71764204|NCT02693132|143030037|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71764205|NCT02693132|143030038|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71764206|NCT00862641|143030054|SUPERIORITY_OR_OTHER|||||||0.1451||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with \<15 subjects were pooled.||||||0.1451
71764207|NCT00862641|143030054|SUPERIORITY_OR_OTHER|||||||0.579||95.0|||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the CMH test stratified by investigative site. Sites with less than 15 subjects were pooled.||||||0.5790
71764208|NCT00862641|143030057|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0029
71764209|NCT00862641|143030057|SUPERIORITY_OR_OTHER|||||||0.6189||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.6189
71764210|NCT00862641|143030058|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0015
71764211|NCT00862641|143030058|SUPERIORITY_OR_OTHER|||||||0.4385||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.4385
71764212|NCT00862641|143030059|SUPERIORITY_OR_OTHER|||||||0.0789||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0789
71764213|NCT00862641|143030059|SUPERIORITY_OR_OTHER|||||||0.0258||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0258
71764214|NCT00862641|143030060|SUPERIORITY_OR_OTHER|||||||0.2087||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.2087
71764215|NCT00862641|143030060|SUPERIORITY_OR_OTHER|||||||0.0289||95.0|||||ANCOVA|||P-value applies to 'Change at Hour 2'||||0.0289
71764216|NCT00862641|143030061|SUPERIORITY_OR_OTHER|||||||0.9904||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.9904
71764217|NCT00862641|143030061|SUPERIORITY_OR_OTHER|||||||0.8085||95.0|||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."||||0.8085
71764218|NCT02365480|143030065|OTHER||Odds Ratio (OR)|1.91||||0.6|TWO_SIDED|95.0|0.1|36.37|||Fisher Exact|||||36.37|0.10|0.60
71764219|NCT03952039|143030080|SUPERIORITY||Difference in Proportion|29.6|||<|0.0001|TWO_SIDED|95.0|19.9|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||39.4|19.9|<0.0001
71764220|NCT03952039|143030081|SUPERIORITY|Stratified analysis (based on CRF)|Difference in Proportion|17.1||||0.0033|TWO_SIDED|95.0|4.8|29.4|||Cochran-Mantel-Haenszel|CMH test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||||29.4|4.8|0.0033
71764221|NCT03952039|143030082|SUPERIORITY||Difference in Proportion|33.5|||<|0.0001|TWO_SIDED|95.0|21.9|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test using the Greenland and Robins method to adjust for stratification factors: spleen size by palpation and platelet counts.||Stratified analysis (based on CRF)||45.1|21.9|<0.0001
71764222|NCT03952039|143030085|SUPERIORITY||Greenland and Robins method|19.9|||||TWO_SIDED|95.0|10.0|29.7|||Greenland and Robins method|||||29.7|10.0|
71764223|NCT00695097|143030095|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline)compared to post-treatment (follow-up) CD3 cell density||||0.25
71764224|NCT00695097|143030095|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline) compared to post-treatment (follow-up) CD3 cell density||||0.46
71764225|NCT00695097|143030095|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||pretreatment (baseline) compared to post-treatment (follow-up) biopsy CD20 cell density||||0.054
71764226|NCT00695097|143030095|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P \< 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (baseline) compared to post-treatment (follow-up) CD20 cell density||||0.62
71764227|NCT05141448|143030096|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.011|||TWO_SIDED|95.0|0.02|0.06|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as senofilcon A C3 (EMO-118) minus omafilcon A|||0.06|0.02|
71764228|NCT03703297|143030102|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.01608|TWO_SIDED|95.0|0.606|0.95|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI calculated using stratified Cox proportional hazards model,adjusting for tumor,node and metastasis(TNM) stage, receipt of prophylactic cranial irradiation(PCI),with treatment as only covariate and ties handled by Efron approach.|||0.950|0.606|0.01608
71764229|NCT03703297|143030103|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.01042|TWO_SIDED|95.0|0.569|0.928|||Log Rank|The analysis was performed using the stratified log-rank test.|Hazard ratio and CI were calculated using stratified Cox proportional hazards model, adjusting for receipt of PCI, with treatment as only covariate and ties handled by Efron approach.|||0.928|0.569|0.01042
71825906|NCT04044664|143156469|OTHER|||||||0.0614|||||||t-test, 1 sided|||||||0.0614
71705841|NCT01292473|142929656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.73||||0.1575|TWO_SIDED|95.0|-6.53|1.07||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||1.07|-6.53|0.1575
71705842|NCT01292473|142929656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.69||||0.0001||95.0|-11.49|-3.88||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-3.88|-11.49|0.0001
71705843|NCT01292473|142929656|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.4|||<|0.0001|TWO_SIDED|95.0|-16.13|-8.66||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-8.66|-16.13|<0.0001
71653823|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.3|2.78|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.78|1.30|0.0009
71653824|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0004|TWO_SIDED|95.0|1.36|2.9|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.90|1.36|0.0004
71653825|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0015|TWO_SIDED|95.0|1.29|2.96|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.29|0.0015
71653826|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0008|TWO_SIDED|95.0|1.34|3.07|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.07|1.34|0.0008
71653827|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0251|TWO_SIDED|95.0|1.07|2.75|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.75|1.07|0.0251
71653828|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0276|TWO_SIDED|95.0|1.06|2.72|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|1.06|0.0276
71653829|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0404|TWO_SIDED|95.0|1.03|3.71|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.71|1.03|0.0404
71653830|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3486|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.72|0.70|0.3486
71653831|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.42|3.02|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.02|1.42|0.0002
71653832|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0006|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.32|0.0006
71764230|NCT01221285|143030162|SUPERIORITY_OR_OTHER||Fold change|1.8||||0.02|TWO_SIDED|95.0|1.1|2.8|||Fold change||Numerator is geometric mean post-baseline IgE. Denominator is baseline IgE.|||2.8|1.1|0.02
71764231|NCT01221285|143030163|SUPERIORITY_OR_OTHER||Fold change|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.4|||Fold change||Numerator is geometric mean post-baseline IgG. Denominator is baseline IgG.|||3.4|1.8|<0.0001
71653833|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0002|TWO_SIDED|95.0|1.41|3.05|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.05|1.41|0.0002
71653834|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.46|3.15|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.15|1.46|<.0001
71653835|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0024|TWO_SIDED|95.0|1.28|3.18|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.18|1.28|0.0024
71653836|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0011|TWO_SIDED|95.0|1.35|3.34|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.34|1.35|0.0011
71653837|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0172|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0172
71653838|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.06||||0.0173|TWO_SIDED|95.0|1.14|3.72|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.72|1.14|0.0173
71653839|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0118|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|1.11|0.0118
71653840|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0132|TWO_SIDED|95.0|1.1|2.32|||Regression, Logistic|||Week 8, \>=30%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.32|1.10|0.0132
71653841|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0005|TWO_SIDED|95.0|1.35|2.92|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.92|1.35|0.0005
71653842|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.66||||0.01|TWO_SIDED|95.0|1.13|2.45|||Regression, Logistic|||Week 8, \>=50%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.45|1.13|0.0100
71653843|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0023|TWO_SIDED|95.0|1.28|3.12|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.12|1.28|0.0023
71653844|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0322|TWO_SIDED|95.0|1.04|2.58|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.58|1.04|0.0322
71653845|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2005|TWO_SIDED|95.0|0.81|2.67|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|0.81|0.2005
71653846|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1923|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.68|0.82|0.1923
71653847|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0013|TWO_SIDED|95.0|1.28|2.79|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|1.28|0.0013
71653848|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.68|3.73|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.73|1.68|<.0001
71653849|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.45|3.1|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.10|1.45|<.0001
71653850|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0014|TWO_SIDED|95.0|1.26|2.67|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.67|1.26|0.0014
71653851|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0008|TWO_SIDED|95.0|1.33|2.99|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.99|1.33|0.0008
71653852|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0005|TWO_SIDED|95.0|1.37|3.06|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.06|1.37|0.0005
71653853|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0127|TWO_SIDED|95.0|1.16|3.49|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.49|1.16|0.0127
71653854|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0075|TWO_SIDED|95.0|1.22|3.64|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.64|1.22|0.0075
71825907|NCT04044664|143156470|OTHER|||||||0.0182|||||||t-test, 1 sided|||greater than or equal to 30% decrease from baseline||||0.0182
71653855|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0061|TWO_SIDED|95.0|1.17|2.52|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.52|1.17|0.0061
71825908|NCT04044664|143156470|OTHER|||||||0.0705|||||||t-test, 1 sided|||greater than or equal to 50% decrease from baseline||||0.0705
71825909|NCT03736785|143156472|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
71653856|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0007|TWO_SIDED|95.0|1.33|2.88|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.88|1.33|0.0007
71705844|NCT01292473|142929657|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01||||0.0603|TWO_SIDED|95.0|-4.11|0.09||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.09|-4.11|0.0603
71705845|NCT01292473|142929657|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.51|||<|0.0001|TWO_SIDED|95.0|-6.65|-2.36||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-2.36|-6.65|<0.0001
71705846|NCT01292473|142929657|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.09|||<|0.0001|TWO_SIDED|95.0|-9.26|-4.93||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-4.93|-9.26|<0.0001
71705847|NCT01292473|142929658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.0478|TWO_SIDED|95.0|1.0|2.05||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between Placebo and Omalizumab 75 mg.||2.05|1.00|0.0478
71705848|NCT01292473|142929658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.0101|TWO_SIDED|95.0|1.12|2.26||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||2.26|1.12|0.0101
71705849|NCT01292473|142929658|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.48|3.03||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||3.03|1.48|<0.0001
71705850|NCT01292473|142929659|SUPERIORITY_OR_OTHER|||||||0.3419||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.3419
71705851|NCT01292473|142929659|SUPERIORITY_OR_OTHER|||||||0.001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0010
71705852|NCT01292473|142929659|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.||||<0.0001
71705853|NCT01292473|142929660|SUPERIORITY_OR_OTHER|||||||0.4366||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.4366
71705854|NCT01292473|142929660|SUPERIORITY_OR_OTHER|||||||0.0045||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0045
71705855|NCT01292473|142929660|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||||<0.0001
71705856|NCT01292473|142929661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48||||0.0082|TWO_SIDED|95.0|-4.32|-0.65||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||-0.65|-4.32|0.0082
71825910|NCT03736785|143156472|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
71825911|NCT03736785|143156472|EQUIVALENCE|Equivalence margin is zero.|||||<|0.001||||||P-value reported is within group comparison between Week 32 and baseline.|Mixed Models Analysis|||||||<0.001
71764232|NCT01221285|143030164|SUPERIORITY_OR_OTHER||Fold change|12.9|||<|0.0001|TWO_SIDED|95.0|7.5|22.5|||Fold Change||Numerator is geometric mean post-baseline IgG4. Denominator is baseline IgG4.|||22.5|7.5|<0.0001
71825912|NCT03736785|143156473|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.08|||||TWO_SIDED|90.0|-0.11|0.28|||Mixed Models Analysis|||||0.28|-0.11|
71825913|NCT03736785|143156473|NON_INFERIORITY|Non-inferiority margin is 0.4%|LSMean Difference|0.09|||||TWO_SIDED|90.0|-0.1|0.29|||Mixed Models Analysis|||||0.29|-0.10|
71825914|NCT04511650|143156507|SUPERIORITY|||||||0.4795|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by disease severity.||Pooled Razuprotafib comparison to Placebo. All results are summarized descriptively by treatment arm and expressed as proportions, along with corresponding 95% confidence intervals (CIs) of the difference between response rates, and p-values.||||0.4795
71653857|NCT02697773|142825039|SUPERIORITY|The two comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|1.89||||0.001|TWO_SIDED|95.0|1.29|2.76|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.76|1.29|0.0010
71653858|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0411|TWO_SIDED|95.0|1.02|2.31|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.02|0.0411
71653859|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.72||||0.009|TWO_SIDED|95.0|1.14|2.57|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|1.14|0.0090
71653860|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1149|TWO_SIDED|95.0|0.89|2.86|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.86|0.89|0.1149
71653861|NCT02697773|142825039|SUPERIORITY||Odds Ratio (OR)|1.56||||0.1351|TWO_SIDED|95.0|0.87|2.79|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.79|0.87|0.1351
71653862|NCT02697773|142825039|SUPERIORITY|The two comparisons for 'Participants with ≥50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|2.17|||<|0.0001|TWO_SIDED|95.0|1.48|3.16|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.16|1.48|<.0001
71653863|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0001|TWO_SIDED|95.0|1.45|3.11|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.11|1.45|0.0001
71653864|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.59|3.4|||Regression, Logistic|||Week 2, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.40|1.59|<.0001
71653865|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0312|TWO_SIDED|95.0|1.04|2.39|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.04|0.0312
71764233|NCT01221285|143030165|SUPERIORITY_OR_OTHER||Change|-42.8|||<|0.0001|TWO_SIDED|95.0|-59.4|-26.2|||Change||Numerator is geometric mean post-baseline FAB. Denominator is baseline FAB.|||-26.2|-59.4|<0.0001
71764234|NCT01904773|143030182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|0.9||0.0087||||||Bonferroni-Holm adjustment, compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||Comparison with placebo||||0.0087
71825915|NCT01549652|143156518|SUPERIORITY_OR_OTHER|||||||0.87||||||Students' t-tests for paired samples with Bonferroni correction for multiple comparisons were used to compare differences between the outcome measures for crossover treatment arms (placebo vs. ondansetron).|t-test, 2 sided|||For the purposes of our post-hoc power calculation we considered a 30% treatment effect clinically significant. Based on the mean observed OOWS score during withdrawal during the placebo session and the variance of that mean score and assuming a paired data analysis and an alpha of 0.05, we found that we had 80% power to detect a treatment effect as low as 25% reduction in OOWS.||||0.87
71825916|NCT01549652|143156519|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
71825917|NCT01549652|143156520|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
71825918|NCT01549652|143156521|SUPERIORITY_OR_OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
71825919|NCT01549652|143156522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71825920|NCT01549652|143156523|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71764235|NCT01904773|143030182|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.34|STANDARD_ERROR_OF_MEAN|0.85||0.1198||||||Bonferroni-Holm compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||||||0.1198
71764236|NCT03861988|143030186|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71764237|NCT00220779|143030195|SUPERIORITY_OR_OTHER|||||||0.221||||||0.2g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.221
71764238|NCT00220779|143030195|SUPERIORITY_OR_OTHER|||||||0.471||||||0.4 g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value \> 0.05.||||0.471
71653866|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0003|TWO_SIDED|95.0|1.4|3.19|||Regression, Logistic|||Week 2, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.19|1.40|0.0003
71653867|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0005|TWO_SIDED|95.0|1.48|4.01|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.01|1.48|0.0005
71653868|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0006|TWO_SIDED|95.0|1.45|3.94|||Regression, Logistic|||Week 2, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.94|1.45|0.0006
71653869|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0436|TWO_SIDED|95.0|1.02|4.32|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.32|1.02|0.0436
71653870|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1348|TWO_SIDED|95.0|0.84|3.69|||Regression, Logistic|||Week 2, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.69|0.84|0.1348
71653871|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.58|3.36|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.58|<.0001
71653872|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.46|3.09|||Regression, Logistic|||Week 4, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.46|<.0001
71764239|NCT00281658|143030208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0062|TWO_SIDED|95.0|0.58|0.94||Stratified Log-Rank (one-sided)|Log Rank||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Primary OS analysis cut-off date = 18-Jun-2010||0.94|0.58|0.0062
71764240|NCT00281658|143030209|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.64|0.98|||||The treatment hazard ratio based on the proportional hazard model stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|Final OS analysis cut-0ff date = 23-Nov-2021||0.98|0.64|
71653873|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.62|3.57|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.57|1.62|<.0001
71705857|NCT01292473|142929661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.61|-1.9||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-1.90|-5.61|<0.0001
71705858|NCT01292473|142929661|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.15|||<|0.0001|TWO_SIDED|95.0|-9.03|-5.27||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and the omalizumab 300 mg groups.||-5.27|-9.03|<0.0001
71705859|NCT01292473|142929662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.68||||0.1207|TWO_SIDED|95.0|-3.82|0.45||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||0.45|-3.82|0.1207
71705860|NCT01292473|142929662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.51||||0.0215|TWO_SIDED|95.0|-4.64|-0.38||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||-0.38|-4.64|0.0215
71705861|NCT01292473|142929662|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.79||||0.0004|TWO_SIDED|95.0|-5.85|-1.73||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.||-1.73|-5.85|0.0004
71705862|NCT01292473|142929663|SUPERIORITY_OR_OTHER|||||||0.1361||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.||||0.1361
71705863|NCT01292473|142929663|SUPERIORITY_OR_OTHER|||||||0.0905||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.||||0.0905
71764241|NCT00281658|143030210|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.66|||||The Pike estimator of the treatment hazard ratio based on the log rank test stratifying for metastatic disease sites and hormonal status. A hazard ratio \<1 indicates a lower risk with Lapatinib 1500mg + Paclitaxel compared with Placebo + Paclitaxel.|||0.66|0.44|
71764242|NCT00281658|143030211|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|1.54|3.47||||||||3.47|1.54|
71764243|NCT00281658|143030212|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34|||||TWO_SIDED|95.0|1.54|3.58||||||||3.58|1.54|
71764244|NCT00281658|143030217|OTHER||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.07|7.57||||||Participants with PIK3CA wild-type||7.57|1.07|
71825921|NCT01549652|143156524|SUPERIORITY_OR_OTHER|||||||0.6||||||Students' t-test for paired samples were used to compare differences between the outcome measures for treatment groups (placebo vs. ondansetron).|t-test, 2 sided|||We aimed for a 20% change in OOWS score to show the treatment effect with a power of 80% and an alpha of 0.05, yielding a target of 23 patients per treatment group.||||0.6
71825922|NCT01549652|143156525|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
71705864|NCT01292473|142929663|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg.||||<0.0001
71764245|NCT00281658|143030218|OTHER||Odds Ratio (OR)|2.42|||||TWO_SIDED|95.0|1.28|4.63||||||Participants with PTEN low||4.63|1.28|
71764246|NCT00281658|143030218|OTHER||Odds Ratio (OR)|2.21|||||TWO_SIDED|95.0|1.04|4.82||||||Participants without PTEN low||4.82|1.04|
71764247|NCT00281658|143030220|OTHER||Odds Ratio (OR)|3.15|||||TWO_SIDED|95.0|1.58|6.49||||||Participants with PTEN low||6.49|1.58|
71764248|NCT00281658|143030220|OTHER||Odds Ratio (OR)|2.49|||||TWO_SIDED|95.0|1.13|5.66||||||Participants without PTEN low||5.66|1.13|
71764249|NCT00813943|143030222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.0328|TWO_SIDED|95.0|0.484|0.972||P-value is not adjusted for multiple testing.|Log Rank|||||0.972|0.484|0.0328
71764250|NCT00813943|143030222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.858||||0.3771|TWO_SIDED|95.0|0.612|1.204||P-value is not adjusted for multiple testing.|Log Rank|||||1.204|0.612|0.3771
71764251|NCT01235598|143030243|SUPERIORITY_OR_OTHER||Median difference within group changes|-1.5||||0.049|TWO_SIDED|95.0|-3.0|0.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0|-3.0|0.049
71764252|NCT01235598|143030244|SUPERIORITY_OR_OTHER||Median Difference within group changes|-1.0||||0.206|TWO_SIDED|95.0|-3.0|1.0||Two-sided p-value is presented, with p \< 0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \< 0.05). Hypothesis testing was stopped if and when a non-significant result was obtained. Testing was stopped in the next step.||1.0|-3.0|0.206
71825923|NCT01549652|143156526|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
71705865|NCT05463705|142929720|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.88|1.96||||||||1.96|0.88|
71825924|NCT01549652|143156527|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.40
71825925|NCT01549652|143156528|SUPERIORITY_OR_OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
71825926|NCT01549652|143156529|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71825927|NCT01972152|143156531|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis.||||||0.24
71825928|NCT01972152|143156532|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.34
71825929|NCT01972152|143156532|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||0.01
71825930|NCT01972152|143156533|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
71825931|NCT01972152|143156534|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
71825932|NCT01972152|143156535|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
71764253|NCT01235598|143030248|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.0035||||0.164|TWO_SIDED|95.0|-0.012|0.0025||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.0025|-0.0120|0.164
71764254|NCT01235598|143030249|SUPERIORITY_OR_OTHER||Median difference within group changes|-0.069||||0.865|TWO_SIDED|95.0|-0.201|0.138||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||0.1380|-0.2010|0.865
71705866|NCT05463705|142929720|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system),72,73 an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||||1.52|0.66|
71705867|NCT05463705|142929721|SUPERIORITY|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.83|1.61||||||||1.61|0.83|
71705868|NCT05463705|142929721|EQUIVALENCE|We estimated that 178 providers caring for 1,249 eligible patients would provide 80% power to observe an 11 percentage-point difference in prescribing rates between each intervention arm and control, assuming a control arm prescribing rate of 30%, an ICC of 0.07 (estimated based on prior studies in this system), an average of 7 patients per provider, and a type I error rate of 5%.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.64|1.3||||||||1.30|0.64|
71705869|NCT05463705|142929722|SUPERIORITY||Difference in HbA1c %|0.18|||||TWO_SIDED|95.0|-0.07|0.43||||||||0.43|-0.07|
71705870|NCT05463705|142929722|SUPERIORITY||Difference in HbA1c %|0.06|||||TWO_SIDED|95.0|-0.22|0.34||||||||0.34|-0.22|
71705871|NCT02046200|142929774|SUPERIORITY_OR_OTHER|||||||0.0563|||||||ANOVA|||||||0.0563
71705872|NCT02046200|142929775|SUPERIORITY_OR_OTHER|||||||0.0342|||||||ANOVA|||||||0.0342
71764255|NCT01235598|143030250|SUPERIORITY_OR_OTHER||Median difference within group changes|-421.5||||0.015|TWO_SIDED|95.0|-1542.5|-47.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p \<0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.||-47.0|-1542.5|0.015
71764256|NCT01235598|143030262|SUPERIORITY_OR_OTHER|||||||0.394|||||||Spearman rank correlation|||||||0.394
71764257|NCT01235598|143030263|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Spearman rank correlation|||||||0.625
71764258|NCT01235598|143030264|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Spearman rank correlation|||||||0.128
71764259|NCT01235598|143030265|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Spearman rank correlation|||||||0.732
71705873|NCT02046200|142929776|SUPERIORITY_OR_OTHER|||||||0.1597|||||||ANOVA|||||||0.1597
71705874|NCT02046200|142929777|SUPERIORITY_OR_OTHER|||||||0.7617|||||||ANOVA|||||||0.7617
71705875|NCT02046200|142929778|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||||||0.93
71705876|NCT02046200|142929779|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||||||0.95
71705877|NCT02046200|142929780|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||||||0.43
71705878|NCT02046200|142929781|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
71705879|NCT02046200|142929782|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||||||0.21
71705880|NCT02046200|142929783|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||||||0.09
71705881|NCT02046200|142929784|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||||||0.99
71705882|NCT01691482|142929791|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
71705883|NCT01691482|142929791|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
71705884|NCT01691482|142929791|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
71705885|NCT01691482|142929791|SUPERIORITY_OR_OTHER||Slope|0.062|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
71705886|NCT01691482|142929795|SUPERIORITY_OR_OTHER||Adjusted Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.067|0.049|
71705887|NCT01691482|142929795|SUPERIORITY_OR_OTHER||Adjusted Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.080|0.062|
71705888|NCT01691482|142929795|SUPERIORITY_OR_OTHER||Adjusted Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.062|0.044|
71705889|NCT01691482|142929795|SUPERIORITY_OR_OTHER||Adjusted Mean|0.062||||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.071|0.053|
71705890|NCT01691482|142929796|SUPERIORITY_OR_OTHER||Adjusted Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.058|0.076|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.076|0.058|
71705891|NCT01691482|142929796|SUPERIORITY_OR_OTHER||Adjusted Mean|0.07|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.061|0.079|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.079|0.061|
71705892|NCT01691482|142929796|SUPERIORITY_OR_OTHER||Adjusted Mean|0.069|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.06|0.078|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.078|0.060|
71705893|NCT01691482|142929796|SUPERIORITY_OR_OTHER||Adjusted Mean|0.064|STANDARD_ERROR_OF_MEAN|0.0045||||95.0|0.055|0.073|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.073|0.055|
71705894|NCT01691482|142929797|SUPERIORITY_OR_OTHER||Adjusted Mean|0.228|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.2|0.255|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.255|0.200|
71705895|NCT01691482|142929797|SUPERIORITY_OR_OTHER||Adjusted Mean|0.231|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.203|0.258|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.258|0.203|
71705896|NCT01691482|142929797|SUPERIORITY_OR_OTHER||Adjusted Mean|0.232|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.204|0.259|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.259|0.204|
71705897|NCT01691482|142929797|SUPERIORITY_OR_OTHER||Adjusted Mean|0.217|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.19|0.245|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.|||0.245|0.190|
71764260|NCT01235598|143030266|SUPERIORITY_OR_OTHER|||||||0.411|TWO_SIDED||||||Spearman rank correlation|||||||0.411
71764261|NCT01235598|143030267|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman rank correlation|||||||0.208
71705898|NCT00395512|142929824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.78|-0.33||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.||-0.33|-0.78|<0.001
71705899|NCT00395512|142929824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.53|-0.98|<0.001
71705900|NCT00395512|142929824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.63|-0.18||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||||-0.18|-0.63|<0.001
71705901|NCT00395512|142929825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.12|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-0.12|-0.55|0.003
71705902|NCT00395512|142929825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.30|-0.74|<0.001
71705903|NCT00395512|142929825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-0.51|-0.94|<0.001
71764262|NCT01235598|143030268|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.254|TWO_SIDED|95.0|-1.0|0.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||0.0|-1.0|0.254
71825933|NCT01972152|143156535|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
71825934|NCT01972152|143156536|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||0.16
71825935|NCT01972152|143156537|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
71705904|NCT00395512|142929826|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.017|TWO_SIDED|95.0|-20.3|-2.0|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.||-2.0|-20.3|0.017
71825936|NCT01972152|143156537|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
71764263|NCT01235598|143030269|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.472|TWO_SIDED|95.0|-2.0|1.0||Two-sided p-value is presented, with p \<0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|||1.0|-2.0|0.472
71705905|NCT00395512|142929826|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9||||0.006|TWO_SIDED|95.0|-22.0|-3.8|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-3.8|-22.0|0.006
71705906|NCT00395512|142929826|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.5|||<|0.001|TWO_SIDED|95.0|-33.5|-15.4|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.||-15.4|-33.5|<0.001
71764264|NCT00395343|143030279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.7|-0.42|||ANCOVA|Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)||||-0.42|-0.70|<0.001
71764265|NCT00395343|143030280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.001||95.0|-23.4|-6.5|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-6.5|-23.4|<0.001
71705907|NCT04576949|142929875|SUPERIORITY||Odds Ratio (OR)|8.0|||<|0.0001|TWO_SIDED|95.0|3.94|16.25||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 3 to Week 6||16.25|3.94|< 0.0001
71705908|NCT04576949|142929875|SUPERIORITY||Marginal Difference in Proportions|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.25||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.25|0.16|<0.0001
71705909|NCT04576949|142929876|SUPERIORITY||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.69|11.57||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 9 to Week 12||11.57|3.69|< 0.0001
71764266|NCT00395343|143030281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.1|||<|0.001||95.0|-47.1|-25.1|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum||||-25.1|-47.1|<0.001
71764267|NCT00395343|143030282|SUPERIORITY_OR_OTHER||Geometric Mean Difference|36.5||||0.01||95.0|8.9|64.7|||ANCOVA|Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum||||64.7|8.9|0.01
71764268|NCT00395343|143030283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.6|||<|0.001||95.0|1.89|6.85||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum||||6.85|1.89|<0.001
71764269|NCT00395343|143030284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.584||95.0|0.45|4.18||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|||4.18|0.45|0.584
71764270|NCT00395343|143030285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.72|-0.4|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction||||-0.40|-0.72|<0.001
71764271|NCT00606905|143030299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.05|TWO_SIDED|95.0|0.41|4.61|||Chi-squared|||||4.61|0.41|<0.05
71705910|NCT04576949|142929876|SUPERIORITY||Marginal Difference in Proportions|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.3||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.30|0.20|<0.0001
71705911|NCT04576949|142929877|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0016|TWO_SIDED|95.0|1.5|10.24||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations|||Abstinence from Week 6 to Week 24|Stratified by site|10.24|1.50|0.0016
71705912|NCT04576949|142929877|SUPERIORITY||Marginal Difference in Proportions|0.06||||0.0015|TWO_SIDED|95.0|0.03|0.09||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.09|0.03|0.0015
71705913|NCT04576949|142929878|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.0001|TWO_SIDED|95.0|2.81|11.09||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Abstinence from Week 12 to Week 24||11.09|2.81|< 0.0001
71705914|NCT04576949|142929878|SUPERIORITY||Marginal Difference in Proportions|0.16|||<|0.0001|TWO_SIDED|95.0|0.11|0.2||p-value for difference in proportions|Cochran-Mantel-Haenszel|||||0.20|0.11|<.0001
71825937|NCT01972152|143156538|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Data were log transformed for analysis||||||<0.001
71825938|NCT01972152|143156538|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Data were log transformed for analysis.|Mixed Models Analysis|||||||<0.001
71825939|NCT01972152|143156539|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71825940|NCT01972152|143156539|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71825941|NCT01194258|143156542|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was set at 0.40.|LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.041||0.3876|TWO_SIDED|95.0|-0.12|0.05|||Mixed Models Analysis|||Approximately 110 participants were planned to be enrolled to allow approximately 88 participants to complete both treatment periods. Assuming a dropout rate of ≤20%, an intra-participant correlation of 0.80, a standard deviation of 1.2, and a true difference of 0, the study would have \>90% power to show that either Lispro-PH20 or Aspart-PH20 (each tested separately) was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.05|-0.12|0.3876
71705915|NCT04576949|142929879|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3484|TWO_SIDED|95.0|0.75|2.33||Two-sided, calculated by exact computations with clinical site as a stratifier.|exact computations||Stratified by site|Relapse free from Week 6 to Week 24||2.33|0.75|0.3484
71738956|NCT03637517|142990707|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.175||||0.0192|TWO_SIDED|90.0|1.051|1.312|||ANOVA|||||1.312|1.051|0.0192
71738957|NCT03637517|142990708|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.898||||0.1759|TWO_SIDED|90.0|0.787|1.024|||ANOVA||Regimen B to A|||1.024|0.787|0.1759
71653874|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.74|3.82|||Regression, Logistic|||Week 4, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.74|<.0001
71738958|NCT03637517|142990708|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.172||||0.0496|TWO_SIDED|90.0|1.027|1.338|||ANOVA||Regimen C to B|||1.338|1.027|0.0496
71738959|NCT03637517|142990709|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|-0.2857|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|-3.4313|2.8599||||||||2.8599|-3.4313|
71653875|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.47|3.7|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.70|1.47|0.0003
71653876|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.45||||0.0001|TWO_SIDED|95.0|1.55|3.89|||Regression, Logistic|||Week 4, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.89|1.55|0.0001
71653877|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.02||||0.031|TWO_SIDED|95.0|1.07|3.82|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.82|1.07|0.0310
71653878|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0088|TWO_SIDED|95.0|1.24|4.34|||Regression, Logistic|||Week 4, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||4.34|1.24|0.0088
71653879|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.49||||0.036|TWO_SIDED|95.0|1.03|2.16|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|1.03|0.0360
71738960|NCT03637517|142990709|EQUIVALENCE|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper \& lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|9.3571|STANDARD_ERROR_OF_MEAN|1.866979|||TWO_SIDED|90.0|6.2115|12.5028|||||Regimen C to B|||12.5028|6.2115|
71738961|NCT03637517|142990711|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.866||||0.1745|TWO_SIDED|90.0|0.727|1.032|||ANOVA|||(ANOVA) will be performed for Tmax, the terminal phase elimination rate constant β, and the natural logarithms of Cmax, AUCt, AUC168, AUCinf, and C168. The model will include the effects for regimen. For the tests on regimen effects, the denominator sum of squares will be the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen will be compared to the respective reference regimen by a test with a significance level of 0.05.||1.032|0.727|0.1745
71738962|NCT03637517|142990711|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.185||||0.1105|TWO_SIDED|90.0|0.995|1.411||For tests on regimen effects, the denominator sum of squares is the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen is compared to the respective reference regimen by a test with a significance level of 0.05.|ANOVA|||||1.411|0.995|0.1105
71825942|NCT00964119|143156553|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|90.0||||P-value \< .05 is the computed p-value for this measurement.|t-test, 2 sided|||PI and lead author left the institution before publishing data. Study has been closed and data files archived.||||<.05
71825943|NCT03727854|143156554|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
71825944|NCT03727854|143156555|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||0.971
71825945|NCT03727854|143156556|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|||||||0.608
71825946|NCT03727854|143156557|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
71825947|NCT03727854|143156558|SUPERIORITY|||||||0.823|||||||t-test, 2 sided|||||||0.823
71825948|NCT03727854|143156559|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
71825949|NCT03727854|143156560|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
71825950|NCT03727854|143156561|SUPERIORITY|||||||0.652|||||||t-test, 2 sided|||||||0.652
71825951|NCT03727854|143156562|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
71764272|NCT04975438|143030302|OTHER||Posterior Median Difference|-33.21|||||TWO_SIDED|95.0|-50.96|-14.84|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis under the hypothetical strategy using an informative prior (robust MAP prior).|||-14.84|-50.96|
71825952|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|2.282||||0.002|TWO_SIDED|95.0|1.344|3.875|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||3.875|1.344|0.002
71825953|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84|||<|0.05|TWO_SIDED|95.0|1.621|4.977|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||4.977|1.621|<0.05
71825954|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.871||||0.005|TWO_SIDED|95.0|1.207|2.899|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.899|1.207|0.005
71825955|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.879||||0.004|TWO_SIDED|95.0|1.227|2.879|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies||2.879|1.227|0.004
71825956|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.943||||0.008|TWO_SIDED|95.0|1.191|3.168|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||3.168|1.191|0.008
71825957|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.459||||0.001|TWO_SIDED|95.0|1.454|4.159|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||4.159|1.454|0.001
71825958|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.776||||0.004|TWO_SIDED|95.0|1.199|2.631|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.631|1.199|0.004
71825959|NCT01078246|143156563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.274|2.717|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies||2.717|1.274|0.001
71825960|NCT01078246|143156564|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.807||||0.255|TWO_SIDED|95.0|0.557|1.168|||Poisson regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.168|0.557|0.255
71825961|NCT01078246|143156564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.646|TWO_SIDED|95.0|0.597|1.376|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.376|0.597|0.646
71825962|NCT01078246|143156564|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.268||||0.182|TWO_SIDED|95.0|0.895|1.795|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.795|0.895|0.182
71825963|NCT01078246|143156564|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.257||||0.188|TWO_SIDED|95.0|0.894|1.768|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.||||1.768|0.894|0.188
71825964|NCT01078246|143156565|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.016||||0.897|TWO_SIDED|95.0|0.796|1.297|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.297|0.796|0.897
71825965|NCT01078246|143156565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.287||||0.07|TWO_SIDED|95.0|0.98|1.69|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.690|0.980|0.070
71825966|NCT01078246|143156565|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.067||||0.575|TWO_SIDED|95.0|0.85|1.339|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.339|0.850|0.575
71825967|NCT01078246|143156565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.626|TWO_SIDED|95.0|0.847|1.319|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.319|0.847|0.626
71825968|NCT01078246|143156567|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.389|||<|0.0001|TWO_SIDED|95.0|0.274|0.551|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.551|0.274|<0.0001
71825969|NCT01078246|143156567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.471|||<|0.05|TWO_SIDED|95.0|0.314|0.707|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||0.707|0.314|<0.05
71825970|NCT01078246|143156567|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.65||||0.015|TWO_SIDED|95.0|1.102|2.47|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.470|1.102|0.015
71764273|NCT04975438|143030303|OTHER||Posterior Median Difference|-9.68|||||TWO_SIDED|95.0|-15.7|-3.6|||||The posterior median of the difference (GSK1070806 - placebo) and 95% credible interval in PCFB in the EASI is presented. Analysis was performed using Bayesian analysis with vague priors and adjusting for baseline EASI.|||-3.60|-15.70|
71764274|NCT01168986|143030320|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
71764275|NCT01168986|143030321|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Mixed Models Analysis|||||||0.18
71764276|NCT01168986|143030322|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Mixed Models Analysis|||||||0.87
71764277|NCT01168986|143030323|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
71764278|NCT00275340|143030330|NON_INFERIORITY_OR_EQUIVALENCE|Study was not powered to determine significant group differences; thus trends are reported for p\<0.20.|||||p<|0||95.0|||||t-test, 2 sided|||Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.||||p<0.20
71764279|NCT02791763|143030346|NON_INFERIORITY|Non-inferiority was to be established as the lower limit of the 95% confidence interval (CI) for the treatment difference was greater than the pre-specified non-inferiority margin (-1.0 g/dL).|Median Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.07|0.28||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|||0.28|-0.07|<.0001
71764280|NCT02791763|143030347|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
71653880|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0039|TWO_SIDED|95.0|1.19|2.51|||Regression, Logistic|||Week 8, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.51|1.19|0.0039
71764281|NCT02791763|143030348|SUPERIORITY||Odds Ratio (OR)|1.01||||0.4941|TWO_SIDED|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.|||3.04|0.33|0.4941
71653881|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.13|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.13|1.43|0.0002
71653882|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.2|2.62|||Regression, Logistic|||Week 8, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.20|0.0040
71653883|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0175|TWO_SIDED|95.0|1.1|2.74|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.74|1.10|0.0175
71764282|NCT01419197|143030449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528|||<|0.0001|TWO_SIDED|95.0|0.422|0.661||The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.661|0.422|<0.0001
71764283|NCT01419197|143030450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.552||||0.0034|TWO_SIDED|95.0|0.369|0.826||The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\<0.363 (p-value \< 0.0000013).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||0.826|0.369|0.0034
71764284|NCT01419197|143030451|SUPERIORITY_OR_OTHER||Difference in Response Percentage|22.7|||<|0.0001|TWO_SIDED|95.0|16.2|29.2|||Mantel Haenszel|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||29.2|16.2|<0.0001
71764285|NCT01419197|143030453|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.6||||0.0011|TWO_SIDED|95.0|5.03|20.09||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||20.09|5.03|0.0011
71764286|NCT01419197|143030453|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.7||||0.1805|TWO_SIDED|95.0|-5.41|28.75||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||28.75|-5.41|0.1805
71764287|NCT01419197|143030454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.115||||0.4952|TWO_SIDED|95.0|0.819|1.517|||Log Rank|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).||1.517|0.819|0.4952
71825971|NCT01078246|143156567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.622||||0.018|TWO_SIDED|95.0|1.085|2.425|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.425|1.085|0.018
71705916|NCT00407030|142929880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-12.0|-5.9||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-5.9|-12.0|<0.001
71705917|NCT00407030|142929886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.001|TWO_SIDED|95.0|-10.4|-4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||-4.6|-10.4|<0.001
71705918|NCT00407030|142929887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.447|TWO_SIDED|95.0|-2.1|4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.||4.6|-2.1|0.447
71705919|NCT03518203|142929911|EQUIVALENCE|A binomial test was used to test 6 month survival in study cohort against an 18% historical rate.|Proportion|0.714|||<|0.0001|TWO_SIDED|||||The a priori threshold was 0.05.|binomial test|||||||<0.0001
71764288|NCT01419197|143030456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0007|TWO_SIDED|95.0|0.539|0.85||The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this second and final interim analysis was HR\<0.748 (p value \< 0.012).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \> 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).||0.850|0.539|0.0007
71764289|NCT01419197|143030457|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|12.4||||0.0003|TWO_SIDED|95.0|5.67|19.14||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||6-month survival||19.14|5.67|0.0003
71764290|NCT01419197|143030457|SUPERIORITY_OR_OTHER||Difference in Survival Percentage|11.0||||0.0104|TWO_SIDED|95.0|2.58|19.33||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood's method.|z-test|||1-year survival||19.33|2.58|0.0104
71764291|NCT00146848|143030460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.75||0.86|TWO_SIDED|95.0|-3.14|3.74|||t-test, 2 sided|||The changes in quality of life were compared between groups using two-sided t-tests.||3.74|-3.14|0.86
71764292|NCT00146848|143030460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.87||0.43|TWO_SIDED|95.0|-2.18|5.16|||t-test, 2 sided|||The difference in changes in quality of life between groups were compared using a t-test.||5.16|-2.18|0.43
71764293|NCT00146848|143030461|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Armitage test for trend|||One sided test testing for shift towards improvement in either atrial support pacing treatment arm compared to the DDD-40 arm.||||0.55
71764294|NCT00146848|143030461|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Armitage test for trend|||||||0.80
71764295|NCT00146848|143030462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.17|STANDARD_ERROR_OF_MEAN|6.35||0.11|TWO_SIDED|95.0|-22.65|2.3|||t-test, 2 sided|||Compare the difference in the changes in physical activity scores between groups using a t-test.||2.30|-22.65|0.11
71764296|NCT00146848|143030462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|STANDARD_ERROR_OF_MEAN|6.55||0.04|TWO_SIDED|95.0|-26.11|-0.37|||t-test, 2 sided|||"Compare the difference in the changes in physical activity scores between groups using a t-test.~To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance."||-0.37|-26.11|0.04
71764297|NCT01798849|143030465|OTHER||Difference in Least-square (LS) Means|-0.5||||0.732|TWO_SIDED|95.0|-3.42|2.43|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.43|-3.42|0.732
71764298|NCT01798849|143030465|OTHER||Difference in LS means|-0.94||||0.531|TWO_SIDED|95.0|-3.94|2.06|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.06|-3.94|0.531
71764299|NCT01798849|143030465|OTHER||Difference in LS Means|-2.88||||0.056|TWO_SIDED|95.0|-5.83|0.08|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.08|-5.83|0.056
71764300|NCT01798849|143030465|OTHER||Difference in LS means|-2.92||||0.063|TWO_SIDED|95.0|-6.0|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-6.00|0.063
71764301|NCT01798849|143030465|OTHER||Difference in LS means|-4.89||||0.002|TWO_SIDED|95.0|-7.79|-1.99|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.99|-7.79|0.002
71705920|NCT04560309|142929930|SUPERIORITY|||||||0.993||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.993
71705921|NCT04560309|142929931|SUPERIORITY|||||||0.883||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.883
71705922|NCT04560309|142929932|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.034
71705923|NCT04560309|142929933|SUPERIORITY|||||||0.038||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.038
71705924|NCT04560309|142929934|SUPERIORITY|||||||0.423||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.423
71653884|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0065|TWO_SIDED|95.0|1.19|2.94|||Regression, Logistic|||Week 8, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.94|1.19|0.0065
71705925|NCT04560309|142929935|SUPERIORITY|||||||0.216||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.216
71705926|NCT04560309|142929936|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.001
71705927|NCT04560309|142929937|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.043
71705928|NCT04560309|142929938|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p \< 0.05|Unpaired T-Test|||||||0.011
71705929|NCT04560309|142929939|SUPERIORITY|||||||0.975||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.975
71705930|NCT04560309|142929940|SUPERIORITY|||||||0.031||||||The threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.031
71705931|NCT04560309|142929941|SUPERIORITY|||||||0.549||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.549
71705932|NCT04560309|142929942|SUPERIORITY|||||||0.645||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.645
71705933|NCT04560309|142929943|SUPERIORITY|||||||0.33||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||After induction to anesthesia||||0.330
71705934|NCT04560309|142929943|SUPERIORITY|||||||0.352||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||5 minutes after cardiopulmonary bypass||||0.352
71705935|NCT04560309|142929943|SUPERIORITY|||||||0.544||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||2 hours after cardiopulmonary bypass||||0.544
71705936|NCT04560309|142929943|SUPERIORITY|||||||0.022||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||6 hours after cardiopulmonary bypass||||0.022
71705937|NCT04560309|142929943|SUPERIORITY|||||||0.038||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||24 hour after cardiopulmonary bypass||||0.038
71705938|NCT04560309|142929944|SUPERIORITY|||||||0.2||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.200
71653885|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0796|TWO_SIDED|95.0|0.94|3.23|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|0.94|0.0796
71653886|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0718|TWO_SIDED|95.0|0.95|3.27|||Regression, Logistic|||Week 8, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.27|0.95|0.0718
71653887|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0004|TWO_SIDED|95.0|1.36|2.96|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.96|1.36|0.0004
71653888|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.93|||Regression, Logistic|||Week 12, \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.93|1.78|<.0001
71653889|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.11||||0.0001|TWO_SIDED|95.0|1.44|3.09|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.09|1.44|0.0001
71653890|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0002|TWO_SIDED|95.0|1.42|3.04|||Regression, Logistic|||Week 12, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.04|1.42|0.0002
71653891|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.41|3.23|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.23|1.41|0.0003
71653892|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.52|3.46|||Regression, Logistic|||Week 12, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.46|1.52|<.0001
71705939|NCT04560309|142929945|SUPERIORITY|||||||0.72||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.720
71705940|NCT04560309|142929946|SUPERIORITY|||||||0.042||||||The threshold of statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.042
71705941|NCT04560309|142929947|SUPERIORITY|||||||0.044||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.044
71705942|NCT04560309|142929948|SUPERIORITY|||||||0.349||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.349
71705943|NCT04560309|142929949|SUPERIORITY|||||||0.95||||||The threshold of statistical significance was p \< 0.05|Unpaired T-Test|||||||0.950
71705944|NCT04560309|142929950|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.862|||||||Wilcoxon (Mann-Whitney)|||||||0.862
71705945|NCT04560309|142929951|SUPERIORITY|The threshold of statistical significance was p \< 0.05||||||0.075|||||||Wilcoxon (Mann-Whitney)|||||||0.075
71705946|NCT00567112|142929972|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.92|1.05|||ANOVA|||OCT (fasted)/DFC (fasted)||1.05|0.92|>0.200
71705947|NCT00567112|142929973|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|TWO_SIDED|90.0|0.8|1.19|||ANOVA|||OCT (fasted)/DFC (fasted)||1.19|0.80|>0.200
71705948|NCT00567112|142929974|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio of OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.92||||0.026|TWO_SIDED|90.0|0.86|0.98|||ANOVA|||OCT (after meal)/OCT (fasted)||0.98|0.86|0.026
71705949|NCT00567112|142929975|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.59|||<|0.001|TWO_SIDED|90.0|0.49|0.72|||ANOVA|||OCT (after meal)/OCT (fasted)||0.72|0.49|<0.001
71705950|NCT00567112|142929976|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
71705951|NCT00567112|142929977|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||ANOVA|||OCT (fasted)/DFC (fasted)||||>0.200
71705952|NCT00567112|142929978|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||OCT (after meal)/OCT (fasted)||||<0.001
71764302|NCT01798849|143030465|OTHER||Difference in LS means|-5.31||||0.001|TWO_SIDED|95.0|-8.32|-2.31|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.31|-8.32|0.001
71764303|NCT01798849|143030465|OTHER||Difference in LS means|-5.61||||0.001|TWO_SIDED|95.0|-8.62|-2.6|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.60|-8.62|0.001
71705953|NCT00567112|142929979|SUPERIORITY_OR_OTHER||||||>|0.2|||||||ANOVA|||OCT (after meal)/OCT (fasted)||||>0.200
71705954|NCT01125748|142929999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||||TWO_SIDED|95.0|5.0|33.6||||||||33.6|5.0|
71705955|NCT02405962|142930001|SUPERIORITY||Adjusted Incidence Rate Ratio|0.2|||<|0.05|TWO_SIDED|95.0|0.08|0.53|||Mixed Models Analysis|||||0.53|0.08|<0.05
71705956|NCT01028391|142930016|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-0.76|-0.26|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) HbA1c.|||-0.26|-0.76|
71705957|NCT01028391|142930017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5|STANDARD_ERROR_OF_MEAN|4.0||||95.0|-16.3|-0.7|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) FPG.|||-0.7|-16.3|
71764304|NCT01798849|143030465|OTHER||Difference in LS means|-7.56|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.63|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.63|-10.50|<0.0001
71705958|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.61|1.07||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.07|0.61|
71705959|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.87|
71705960|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC Ratio|1.42|||||TWO_SIDED|95.0|1.03|1.96||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.96|1.03|
71705961|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.84|0.46|
71705962|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.66|1.2||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.66|
71705963|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.44|||||TWO_SIDED|95.0|1.02|2.04||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.04|1.02|
71705964|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.82|1.32||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.32|0.82|
71705965|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.86|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.86|
71705966|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.79|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.79|
71764305|NCT01798849|143030468|OTHER||Difference in LS means|-2.34||||0.165|TWO_SIDED|95.0|-5.7|1.02|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.02|-5.70|0.165
71653893|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.09||||0.0113|TWO_SIDED|95.0|1.18|3.68|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.68|1.18|0.0113
71653894|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.19||||0.0064|TWO_SIDED|95.0|1.25|3.85|||Regression, Logistic|||Week 12, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.85|1.25|0.0064
71653895|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.58||||0.02|TWO_SIDED|95.0|1.07|2.31|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.31|1.07|0.0200
71653896|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0002|TWO_SIDED|95.0|1.43|3.14|||Regression, Logistic|||Week 16 \>=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.14|1.43|0.0002
71653897|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0005|TWO_SIDED|95.0|1.34|2.87|||Regression, Logistic|||Week 16 \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.34|0.0005
71653898|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0141|TWO_SIDED|95.0|1.11|2.56|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.56|1.11|0.0141
71653899|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.26|2.87|||Regression, Logistic|||Week 16, \>=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.87|1.26|0.0022
71653900|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2286|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.50|0.80|0.2286
71653901|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|1.47||||0.1808|TWO_SIDED|95.0|0.84|2.57|||Regression, Logistic|||Week 16, \>=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.57|0.84|0.1808
71705967|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.77|1.34||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.34|0.77|
71705968|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
71705969|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.74|1.4||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.40|0.74|
71705970|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.57|0.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.97|0.57|
71705971|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.65|1.11||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.11|0.65|
71705972|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMCratio|1.14|||||TWO_SIDED|95.0|0.84|1.56||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.56|0.84|
71705973|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.97|1.94||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.94|0.97|
71705974|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.78|1.55||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.55|0.78|
71705975|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.54|1.19||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.19|0.54|
71705976|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.61|1.05||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.05|0.61|
71705977|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.95|||||TWO_SIDED|95.0|0.73|1.25||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.73|
71825972|NCT01078246|143156568|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.75||||0.423|TWO_SIDED|95.0|0.37|1.517|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.517|0.370|0.423
71825973|NCT01078246|143156568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.208||||0.631|TWO_SIDED|95.0|0.559|2.612|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.612|0.559|0.631
71825974|NCT01078246|143156568|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.845||||0.592|TWO_SIDED|95.0|0.458|1.561|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.561|0.458|0.592
71653902|NCT02697773|142825041|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.57|3.36|||Regression, Logistic|||Week 16, \>=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||3.36|1.57|<.0001
71653903|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.44||||0.1463|TWO_SIDED|95.0|0.88|2.34|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.34|0.88|0.1463
71653904|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9644|TWO_SIDED|95.0|0.6|1.62|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.62|0.60|0.9644
71653905|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0422|TWO_SIDED|95.0|1.02|2.59|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.59|1.02|0.0422
71653906|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1995|TWO_SIDED|95.0|0.85|2.16|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.16|0.85|0.1995
71653907|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4878|TWO_SIDED|95.0|0.75|1.84|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.84|0.75|0.4878
71653908|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7856|TWO_SIDED|95.0|0.68|1.67|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.67|0.68|0.7856
71653909|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0476|TWO_SIDED|95.0|1.0|2.39|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.39|1.00|0.0476
71653910|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0124|TWO_SIDED|95.0|1.12|2.63|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.63|1.12|0.0124
71653911|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.66||||0.0307|TWO_SIDED|95.0|1.05|2.62|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.62|1.05|0.0307
71653912|NCT02697773|142825043|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0846|TWO_SIDED|95.0|0.95|2.35|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||2.35|0.95|0.0846
71653913|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0319|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.03|-0.63|0.0319
71705978|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.87|1.64||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.64|0.87|
71705979|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|3.62|||||TWO_SIDED|95.0|2.76|4.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.74|2.76|
71825975|NCT01078246|143156568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.022||||0.943|TWO_SIDED|95.0|0.565|1.85|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.850|0.565|0.943
71825976|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.708||||0.109|TWO_SIDED|95.0|0.464|1.08|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.080|0.464|0.109
71825977|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.356|TWO_SIDED|95.0|0.486|1.296|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||1.296|0.486|0.356
71825978|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.556||||0.039|TWO_SIDED|95.0|1.022|2.37|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.370|1.022|0.039
71825979|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.033|TWO_SIDED|95.0|1.036|2.361|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||||2.361|1.036|0.033
71825980|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.125|TWO_SIDED|95.0|0.861|3.437|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen.||||3.437|0.861|0.125
71825981|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.056||||0.881|TWO_SIDED|95.0|0.517|2.155|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen.||||2.155|0.517|0.881
71825982|NCT01078246|143156569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.077||||0.107|TWO_SIDED|95.0|0.854|5.05|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen.||||5.05|0.854|0.107
71825983|NCT01081145|143156570|SUPERIORITY_OR_OTHER_LEGACY||Difference in treatment failures|-15.6||||0.006|TWO_SIDED|95.0|-26.6|-4.5|||Cochran-Mantel-Haenszel|||||-4.5|-26.6|0.006
71825984|NCT01081145|143156571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Log Rank|||||||0.003
71825985|NCT01081145|143156572|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-6.24|||<|0.001|TWO_SIDED|95.0|-9.01|-3.48||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-3.48|-9.01|<0.001
71764306|NCT01798849|143030468|OTHER||Difference in LS means|-3.53||||0.038|TWO_SIDED|95.0|-6.86|-0.21|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.21|-6.86|0.038
71825986|NCT01081145|143156573|SUPERIORITY_OR_OTHER_LEGACY||Difference in percent of subjects|17.5||||0.001|TWO_SIDED|95.0|6.6|28.5||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||28.5|6.6|0.001
71825987|NCT01081145|143156574|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.06||||0.118|TWO_SIDED|95.0|-0.14|0.02||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.02|-0.14|0.118
71825988|NCT01081145|143156577|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
71825989|NCT01081145|143156581|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided|||||||<0.001
71825990|NCT03593070|143156607|OTHER|Analyses compared changes in total scores for the MM-CGI from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.646|STANDARD_DEVIATION|0.622||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
71764307|NCT01798849|143030468|OTHER||Difference in LS means|-6.32||||0|TWO_SIDED|95.0|-9.55|-3.1|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.10|-9.55|0.000
71825991|NCT03593070|143156608|OTHER||Slope|0.444|STANDARD_DEVIATION|0.105||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||Analyses compared changes in total scores for the CESD from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).||||0.001
71825992|NCT03593070|143156609|OTHER|Analyses compared changes in total State Trait Anxiety Inventory (STAI) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.514|STANDARD_DEVIATION|0.102||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
71825993|NCT03593070|143156610|OTHER|Analyses compared changes in total positive state of mind scale (PSOMS) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT).|Slope|0.653|STANDARD_DEVIATION|0.093||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
71825994|NCT03593070|143156611|OTHER|Analyses compared changes in conflict scores (based on FPCR) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.609|STANDARD_DEVIATION|0.07||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
71825995|NCT03593070|143156612|OTHER|Analyses compared changes in total scores for satisfaction with care measure (FPCT) from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.731|STANDARD_DEVIATION|0.074||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
71825996|NCT03593070|143156613|OTHER|Analyses compared changes in total Family Knowledge of Alzheimer's Test (FKAT) scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT)|Slope|0.687|STANDARD_DEVIATION|0.084||0.001|TWO_SIDED|||||A priori alpha=0.05.|Regression, Linear|||||||0.001
71825997|NCT03593070|143156614|OTHER||Slope|0.527|STANDARD_DEVIATION|0.088||0.001|TWO_SIDED|||||A prior alpha=0.05.|Regression, Linear|||Analyses compared changes in caregiver sense of loss, guilt, and role captivity scores from baseline to 24 weeks, for both arms of the intervention (CGMI-V and MT). This measure uses 51 items of the FPCR measure.||||0.001
71825998|NCT00816829|143156616|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.048
71825999|NCT00816829|143156617|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.203
71826000|NCT00816829|143156618|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.||||0.007
71826001|NCT00816829|143156619|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.199
71826002|NCT00816829|143156620|SUPERIORITY_OR_OTHER|||||||0.114||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.114
71826003|NCT00816829|143156621|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.533
71826004|NCT00816829|143156622|SUPERIORITY_OR_OTHER|||||||0.521||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.521
71764308|NCT01798849|143030468|OTHER||Difference in LS means|-6.63|||<|0.0001|TWO_SIDED|95.0|-9.35|-3.92|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.92|-9.35|<0.0001
71764309|NCT01798849|143030469|OTHER||Difference in LS means|-2.67||||0.128|TWO_SIDED|95.0|-6.14|0.8|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.80|-6.14|0.128
71764310|NCT01798849|143030469|OTHER||Difference in LS means|-0.76||||0.305|TWO_SIDED|95.0|-2.24|0.72|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.72|-2.24|0.305
71764311|NCT01798849|143030469|OTHER||Difference in LS means|-2.03||||0.07|TWO_SIDED|95.0|-4.23|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.17|-4.23|0.070
71705980|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
71764312|NCT01798849|143030469|OTHER||Difference in LS means|-2.84||||0.036|TWO_SIDED|95.0|-5.48|-0.19|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.19|-5.48|0.036
71764313|NCT01798849|143030469|OTHER||Difference in LS means|-4.89|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.37|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.37|-6.40|<0.0001
71764314|NCT01798849|143030469|OTHER||Difference in LS means|-5.37|||<|0.0001|TWO_SIDED|95.0|-7.29|-3.46|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.46|-7.29|<0.0001
71764315|NCT01798849|143030469|OTHER||Difference in LS means|-5.68|||<|0.0001|TWO_SIDED|95.0|-6.7|-4.65|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.65|-6.70|<0.0001
71764316|NCT01798849|143030469|OTHER||Difference in LS means|-8.22|||<|0.0001|TWO_SIDED|95.0|-11.95|-4.5|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-4.50|-11.95|<0.0001
71764317|NCT01798849|143030470|OTHER||Difference in LS means|-1.77||||0.212|TWO_SIDED|95.0|-4.59|1.05|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||1.05|-4.59|0.212
71764318|NCT01798849|143030470|OTHER||Difference in LS means|3.32||||0.05|TWO_SIDED|95.0|0.0|6.64|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||6.64|0.00|0.050
71764319|NCT01798849|143030470|OTHER||Difference in LS means|2.48||||0.016|TWO_SIDED|95.0|0.49|4.47|||Mixed effect model||Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.47|0.49|0.016
71764320|NCT01798849|143030470|OTHER||Difference in LS means|5.21||||0.007|TWO_SIDED|95.0|1.51|8.92|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||8.92|1.51|0.007
71764321|NCT01798849|143030470|OTHER||Difference in LS means|7.06||||0.001|TWO_SIDED|95.0|3.03|11.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.10|3.03|0.001
71764322|NCT01798849|143030470|OTHER||Difference in LS means|6.62||||0.002|TWO_SIDED|95.0|2.54|10.71|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.71|2.54|0.002
71764323|NCT01798849|143030470|OTHER||Difference in LS means|8.11|||<|0.0001|TWO_SIDED|95.0|5.45|10.76|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||10.76|5.45|<0.0001
71764324|NCT01798849|143030470|OTHER||Difference in LS means|14.05|||<|0.0001|TWO_SIDED|95.0|10.54|17.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||17.57|10.54|<0.0001
71705981|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.14|||||TWO_SIDED|95.0|0.1|0.2||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.10|
71705982|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.13|||||TWO_SIDED|95.0|0.8|1.59||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.59|0.80|
71764325|NCT01798849|143030471|OTHER||Difference in LS means|-1.66||||0.202|TWO_SIDED|95.0|-4.24|0.93|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.93|-4.24|0.202
71764326|NCT01798849|143030471|OTHER||Difference in LS means|-2.23||||0.115|TWO_SIDED|95.0|-5.03|0.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.57|-5.03|0.115
71826005|NCT00816829|143156623|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.333
71653914|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0139|TWO_SIDED|95.0|-0.68|-0.08|||ANCOVA|||Week 1:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.08|-0.68|0.0139
71653915|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0011|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.25|-1.03|0.0011
71653916|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0053|TWO_SIDED|95.0|-0.93|-0.16|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.16|-0.93|0.0053
71653917|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.0014|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.08|0.0014
71653918|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.17|-0.36|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.36|-1.17|0.0002
71705983|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.62|
71705984|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.52|1.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.52|
71705985|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|3.49|||||TWO_SIDED|95.0|2.68|4.54||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.54|2.68|
71705986|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.4|0.68||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.68|0.40|
71705987|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.11|0.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.20|0.11|
71705988|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.61|||||TWO_SIDED|95.0|1.15|2.23||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.23|1.15|
71705989|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.89|1.72||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.72|0.89|
71705990|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.53|1.13||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.53|
71705991|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.63|||||TWO_SIDED|95.0|1.28|2.08||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.08|1.28|
71705992|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.03|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.81|
71764327|NCT01798849|143030471|OTHER||Difference in LS means|-2.75||||0.043|TWO_SIDED|95.0|-5.4|-0.09|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.09|-5.40|0.043
71764328|NCT01798849|143030471|OTHER||Difference in LS means|-0.19||||0.901|TWO_SIDED|95.0|-3.22|2.84|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.84|-3.22|0.901
71705993|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.47|0.83||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.83|0.47|
71705994|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.99|||||TWO_SIDED|95.0|1.51|2.63||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.63|1.51|
71705995|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.79|
71705996|NCT01026038|142930018|SUPERIORITY_OR_OTHER||GMC ratio|0.52|||||TWO_SIDED|95.0|0.38|0.72||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.72|0.38|
71705997|NCT01026038|142930019|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71705998|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.429||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.429
71705999|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.314
71706000|NCT01026038|142930019|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71706001|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.552||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.552
71706002|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.499||95.0|||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.499
71706003|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.376||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.376
71706004|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.633
71706005|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.658
71706006|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.544
71706007|NCT01026038|142930019|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706008|NCT01026038|142930019|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706009|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
71706010|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.197
71706011|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.198
71706012|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.443||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.443
71706013|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.261
71706014|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.687
71706015|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.671
71706016|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.253
71706017|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.074
71706018|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
71706019|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
71706020|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.607||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.607
71706021|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.549
71706022|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.864||95.0|||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.864
71706023|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.859||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.859
71706024|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.836
71706025|NCT01026038|142930019|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706026|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.297
71706027|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.145
71706028|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.517
71706029|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.323
71764329|NCT01798849|143030471|OTHER||Mixed effect model|-4.15||||0.002|TWO_SIDED|95.0|-6.74|-1.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|||-1.57|-6.74|0.002
71764330|NCT01798849|143030471|OTHER||Difference in LS means|-3.77||||0.008|TWO_SIDED|95.0|-6.48|-1.06|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.06|-6.48|0.008
71764331|NCT01798849|143030471|OTHER||Difference in LS means|-1.77||||0.201|TWO_SIDED|95.0|-4.51|0.98|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.98|-4.51|0.201
71764332|NCT01798849|143030471|OTHER||Difference in LS means|-4.74||||0.001|TWO_SIDED|95.0|-7.37|-2.11|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-2.11|-7.37|0.001
71764333|NCT01798849|143030472|OTHER||Difference in LS means|-2.53||||0.042|TWO_SIDED|95.0|-4.97|-0.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.10|-4.97|0.042
71764334|NCT01798849|143030472|OTHER||Difference in LS means|-3.29||||0.01|TWO_SIDED|95.0|-5.71|-0.88|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-0.88|-5.71|0.010
71764335|NCT01798849|143030472|OTHER||Difference in LS means|-6.42|||<|0.0001|TWO_SIDED|95.0|-8.94|-3.89|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-3.89|-8.94|<0.0001
71764336|NCT01798849|143030472|OTHER||Difference in LS means|-8.28|||<|0.0001|TWO_SIDED|95.0|-11.32|-5.25|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-5.25|-11.32|<0.0001
71764337|NCT01798849|143030473|OTHER||Difference in LS means|0.54||||0.638|TWO_SIDED|95.0|-1.8|2.87|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.87|-1.80|0.638
71764338|NCT01798849|143030473|OTHER||Difference in LS means|0.72||||0.616|TWO_SIDED|95.0|-2.2|3.63|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||3.63|-2.20|0.616
71706030|NCT01026038|142930019|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.489
71764339|NCT01798849|143030473|OTHER||Difference in LS means|2.33||||0.041|TWO_SIDED|95.0|0.11|4.56|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||4.56|0.11|0.041
71764340|NCT01798849|143030473|OTHER||Difference in LS means|9.14|||<|0.0001|TWO_SIDED|95.0|6.98|11.3|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||11.30|6.98|<0.0001
71764341|NCT01798849|143030474|OTHER||Difference in LS means|-0.65||||0.677|TWO_SIDED|95.0|-3.81|2.52|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.52|-3.81|0.677
71764342|NCT01798849|143030474|OTHER||Difference in LS means|-0.92||||0.554|TWO_SIDED|95.0|-4.08|2.24|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||2.24|-4.08|0.554
71764343|NCT01798849|143030474|OTHER||Difference in LS means|-2.29||||0.137|TWO_SIDED|95.0|-5.35|0.78|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||0.78|-5.35|0.137
71764344|NCT01798849|143030474|OTHER||Difference in LS means|-3.78||||0.006|TWO_SIDED|95.0|-6.37|-1.19|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo|||-1.19|-6.37|0.006
71764345|NCT02428478|143030510|OTHER|||||||0.01||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Tonic analysis||||0.01
71764346|NCT02428478|143030510|OTHER|||||||0.38||||||P\<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Phasic analysis||||0.38
71764347|NCT02428478|143030511|OTHER||Median Change|-0.6||||0.037|TWO_SIDED||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.037
71706031|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC||||0.075
71706032|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.345
71706033|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Fisher Exact|||Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC||||0.628
71706034|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.592||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.592
71706035|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.608
71706036|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706037|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706038|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Fisher Exact|||Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.333
71826006|NCT00816829|143156624|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.264
71764348|NCT02428478|143030511|OTHER||||||>|0.5|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||>0.5
71706039|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
71706040|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
71706041|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
71706042|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.215
71706043|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.714
71706044|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.397||95.0|||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.397
71706045|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
71706046|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
71706047|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706048|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.161
71706049|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.226
71826007|NCT00816829|143156625|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.||||0.401
71706050|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706051|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71706052|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706053|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.237
71706054|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.045
71706055|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.285
71764349|NCT02663934|143030512|SUPERIORITY||Mean Difference (Net)|0.15||||0.31|TWO_SIDED|95.0|0.05|0.25|||ANOVA|||||.25|.05|0.31
71764350|NCT02663934|143030513|SUPERIORITY||Mean Difference (Net)|1.42||||0.24|TWO_SIDED||||||ANOVA|||Change in Global CBF in EXS vs. SIS||||.24
71764351|NCT02663934|143030513|OTHER||Slope|0.41||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Change in Strength \& Change in Frontal Brain Volume in EXS||||.02
71706056|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71706057|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.174
71706058|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.125
71706059|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||0.058
71764352|NCT02663934|143030513|OTHER||Slope|0.4||||0.02|ONE_SIDED|95.0|||||Regression, Linear|||Changes in Brain Volumes associated with changes Memory Performance in EXS||||0.02
71764353|NCT02663934|143030514|OTHER||Slope|0.47||||0.005|ONE_SIDED|95.0|||||Regression, Linear|||Increases in Time Spent in MVPA and Increased Learning Performance in EXS||||.005
71764354|NCT02692391|143030515|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71764355|NCT02692391|143030516|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71706060|NCT01026038|142930020|SUPERIORITY_OR_OTHER|||||||0.092||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||0.092
71764356|NCT02692391|143030517|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
71826008|NCT02197234|143156636|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|77.08|||||TWO_SIDED|90.0|63.41|93.7|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||93.70|63.41|
71706061|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706062|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.||||>0.990
71706063|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706064|NCT01026038|142930020|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.||||>0.990
71706065|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.56|1.0||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.56|
71706066|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.73|1.28||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.28|0.73|
71706067|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC Ratio|1.29|||||TWO_SIDED|95.0|0.92|1.79||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.92|
71706068|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.49|1.0||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.00|0.49|
71764357|NCT02692391|143030518|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71764358|NCT01510769|143030540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.1298|TWO_SIDED|95.0|-0.03|0.23|||Cochran-Mantel-Haenszel|||||0.23|-0.03|0.1298
71764359|NCT01510769|143030540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.29|||<|0.0001|TWO_SIDED|95.0|0.17|0.42|||Cochran-Mantel-Haenszel|||||0.42|0.17|<0.0001
71764360|NCT01510769|143030541|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.04||||0.4453|TWO_SIDED|95.0|-0.07|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.07|0.4453
71764361|NCT01510769|143030541|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.1149|TWO_SIDED|95.0|-0.02|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.02|0.1149
71764362|NCT01510769|143030542|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.03||||0.645|TWO_SIDED|95.0|-0.1|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.10|0.6450
71764363|NCT01510769|143030542|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.06||||0.4118|TWO_SIDED|95.0|-0.08|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.08|0.4118
71764364|NCT01510769|143030543|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.3034|TWO_SIDED|95.0|-0.24|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.24|0.3034
71764365|NCT01510769|143030543|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19||||0.021|TWO_SIDED|95.0|-0.34|-0.04|||Cochran-Mantel-Haenszel|||||-0.04|-0.34|0.0210
71764366|NCT01980485|143030570|NON_INFERIORITY_OR_EQUIVALENCE|This study had 87% power to detect a 40% increase in 28-dayabstinence rates (i.e., from 50% to 70%) based on a two-tailed chi-squared test and alpha = 0.05. We selected this effect size as being at the lower end of the effect size continuum that would be clinically meaningful at 28 days and have the potential to still be meaningful in the longer term even with similar relapse rates in both groups over subsequent months.||||||0.65|||||||Chi-squared|||||||.65
71764367|NCT00744042|143030574|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Testing whether median change in rickets severity from Baseline to Week 24, measured by RGI-C at Week 24, is from zero.|Wilcoxon signed-rank test|The last post-baseline observation carry forward method is used; patients with no post-baseline assessments were imputed as having no change.||One treatment group||||0.0039
71764368|NCT03158285|143030592|SUPERIORITY||Difference in percentage|31.2|||<|0.001|TWO_SIDED|95.0|22.9|39.5|||Cochran-Mantel-Haenszel|||||39.5|22.9|< 0.001
71764369|NCT03158285|143030592|SUPERIORITY||Difference in percentage|30.8|||<|0.001|TWO_SIDED|95.0|22.4|39.1|||Cochran-Mantel-Haenszel|||||39.1|22.4|< 0.001
71826009|NCT02197234|143156637|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|91.46|||||TWO_SIDED|90.0|77.16|108.41|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.||108.41|77.16|
71826010|NCT01656304|143156654|SUPERIORITY_OR_OTHER||Rate|0.333|STANDARD_ERROR_OF_MEAN|0.1217|||TWO_SIDED|80.0|0.2|0.5||||||||.50|.20|
71826011|NCT04391309|143156660|SUPERIORITY|||||||0.435|||||||Log Rank|||||||0.435
71826012|NCT04391309|143156661|SUPERIORITY|||||||1|||||||Fisher Exact|||All categories included in the analysis||||1
71826013|NCT04391309|143156662|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||||||0.391
71826014|NCT04391309|143156663|SUPERIORITY|||||||0.895|||||||Wilcoxon (Mann-Whitney)|||||||0.895
71826015|NCT04391309|143156664|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||||||0.702
71826016|NCT04391309|143156665|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
71826017|NCT04391309|143156666|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis||||1
71826018|NCT04391309|143156667|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the anlysis.||||1
71653919|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.49|-1.33|<.0001
71653920|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.52|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.52|-1.36|<.0001
71653921|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.23||0.0015|TWO_SIDED|95.0|-1.16|-0.28|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.28|-1.16|0.0015
71653922|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.24|-1.12|0.0023
71706069|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.89|||||TWO_SIDED|95.0|0.62|1.27||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.62|
71826019|NCT04391309|143156668|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
71826020|NCT04391309|143156669|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
71826021|NCT04391309|143156670|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
71826022|NCT04391309|143156671|SUPERIORITY|||||||1||||||P-value based on Fishers exact test, which enumerates all possible tables that have same margins as observed \& calculates proportion of tables where values are more extreme than observed. P-value of 1 = the observed table is the most extreme|Fisher Exact|||All categories included in the analysis.||||1
71826023|NCT04548622|143156674|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71826024|NCT04548622|143156675|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71826025|NCT04548622|143156676|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71826026|NCT05826431|143156683|OTHER||Mean Difference (Final Values)|18.65||||0.153|TWO_SIDED||||||Paired samples t-test|||Study analyses were conducted using IBM SPSS Statistics Version 29. Frequencies and descriptive data were tabulated to describe the sample and quantify device use, satisfaction, and perceived impact. Qualitative responses regarding usability and feasibility were summarized based on the themes of the responses.||||0.153
71826027|NCT05826431|143156684|OTHER||Mean Difference (Final Values)|0.61||||0.103|TWO_SIDED||||||Paired samples t-test|||||||0.103
71826028|NCT05826431|143156686|OTHER|Single group, frequencies, and descriptive data|Mean Difference (Final Values)|4.22||||0.083|TWO_SIDED||||||Paired samples t-test|||||||.083
71826029|NCT05826431|143156687|OTHER||Mean Difference (Final Values)|-0.26||||441|TWO_SIDED||||||Paired samples t-test|||||||0441
71826030|NCT05826431|143156688|OTHER||Mean Difference (Final Values)|2.61||||0.095|TWO_SIDED||||||Paired samples t-test|||||||0.095
71826031|NCT05826431|143156689|OTHER||Mean Difference (Final Values)|0.03||||0.487|TWO_SIDED||||||Paired samples t-test|||||||0.487
71826032|NCT05826431|143156690|OTHER||Mean Difference (Final Values)|-0.06||||0.483|TWO_SIDED||||||Paired samples t-test|||||||0.483
71826033|NCT05826431|143156691|OTHER||Mean Difference (Final Values)|-2.82||||0.0483|TWO_SIDED||||||Paired samples t-test|||||||.0483
71826034|NCT05826431|143156692|OTHER||Mean Difference (Final Values)|-0.42||||0.123|TWO_SIDED||||||Paired samples t-test|||||||0.123
71826035|NCT04771273|143156693|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.47||||0.001|TWO_SIDED|95.0|1.66|7.25||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||7.25|1.66|0.0010
71826036|NCT04771273|143156693|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.52|||<|0.0001|TWO_SIDED|95.0|4.35|20.85||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||20.85|4.35|<0.0001
71826037|NCT04771273|143156693|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|7.07|||<|0.0001|TWO_SIDED|95.0|3.1|16.16||The p-value reported is considered nominal.|Regression, Logistic|||The logistic regression model included actual treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||16.16|3.10|<.0001
71706070|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.27|||||TWO_SIDED|95.0|0.84|1.94||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.84|
71706071|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.58|1.03||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.03|0.58|
71706072|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.76|1.33||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.33|0.76|
71706073|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.29|||||TWO_SIDED|95.0|0.93|1.8||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.80|0.93|
71826038|NCT04771273|143156693|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826039|NCT04771273|143156693|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71764370|NCT03158285|143030593|SUPERIORITY||Least Square (LS) Mean difference|-0.2372|||<|0.001|TWO_SIDED|95.0|-0.321|-0.1534|||ANCOVA|||||-0.1534|-0.3210|< 0.001
71764371|NCT03158285|143030593|SUPERIORITY||LS Mean difference|-0.2704|||<|0.001|TWO_SIDED|95.0|-0.3544|-0.1864|||ANCOVA|||||-0.1864|-0.3544|< 0.001
71706074|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.04|||||TWO_SIDED|95.0|0.69|1.58||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.58|0.69|
71706075|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.3|||||TWO_SIDED|95.0|0.86|1.97||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.86|
71706076|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.77|2.03||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.77|
71764372|NCT03158285|143030594|SUPERIORITY||Difference in percentage|17.2|||<|0.001||95.0|10.0|24.4||Nominal|Cochran-Mantel-Haenszel|||||24.4|10.0|< 0.001
71764373|NCT03158285|143030594|SUPERIORITY||Difference in percentage|18.8|||<|0.001|TWO_SIDED|95.0|11.5|26.1||Nominal|Cochran-Mantel-Haenszel|||||26.1|11.5|< 0.001
71764374|NCT03158285|143030595|SUPERIORITY||Difference in percentage|50.9|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||Cochran-Mantel-Haenszel|||||59.7|42.2|<0.001
71764375|NCT03158285|143030595|SUPERIORITY||Difference in percentage|49.8|||<|0.001|TWO_SIDED|95.0|41.2|58.4|||Cochran-Mantel-Haenszel|||||58.4|41.2|< 0.001
71826040|NCT04771273|143156693|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0008|||||||MCP-Mod exponential -2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0008
71826041|NCT04771273|143156693|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826042|NCT04771273|143156693|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826043|NCT04771273|143156693|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826044|NCT04771273|143156694|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.49|||<|0.0001|TWO_SIDED|95.0|2.46|12.28||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||12.28|2.46|<.0001
71826045|NCT04771273|143156694|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.14|||<|0.0001|TWO_SIDED|95.0|4.49|22.87||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||22.87|4.49|<.0001
71706077|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.58|||||TWO_SIDED|95.0|0.42|0.78||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.78|0.42|
71653923|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0512|TWO_SIDED|95.0|-0.89|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.00|-0.89|0.0512
71653924|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.22||0.0693|TWO_SIDED|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||0.03|-0.85|0.0693
71706078|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
71653925|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.0043|TWO_SIDED|95.0|-1.14|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.14|0.0043
71706079|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.58|||||TWO_SIDED|95.0|1.11|2.25||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.25|1.11|
71706080|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.66|
71764376|NCT03158285|143030596|SUPERIORITY||Difference in percentage|21.5|||<|0.001|TWO_SIDED|95.0|13.1|30.0||Nominal|Cochran-Mantel-Haenszel|||||30.0|13.1|< 0.001
71826046|NCT04771273|143156694|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|4.87||||0.0001|TWO_SIDED|95.0|2.18|10.91||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model includes planned treatment, presence of diabetes of any type and Baseline Fibrosis Score. Firth's penalized regression was used.||10.91|2.18|0.0001
71706081|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.54|||||TWO_SIDED|95.0|0.97|2.44||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.44|0.97|
71706082|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.46|||||TWO_SIDED|95.0|0.85|2.51||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.51|0.85|
71826047|NCT04771273|143156694|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0001|||||||MCPMod linear model fit|linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0001
71706083|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.56|
71706084|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.74|1.52||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.52|0.74|
71706085|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|0.87|2.01||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.01|0.87|
71706086|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|2.59|||||TWO_SIDED|95.0|1.8|3.73||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.73|1.80|
71706087|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.26|||||TWO_SIDED|95.0|0.88|1.79||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.79|0.88|
71706088|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.49|||||TWO_SIDED|95.0|0.32|0.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.32|
71706089|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.06|||||TWO_SIDED|95.0|0.61|1.87||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.87|0.61|
71706090|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.19|||||TWO_SIDED|95.0|0.68|2.09||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.09|0.68|
71706091|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.12|||||TWO_SIDED|95.0|0.59|2.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.15|0.59|
71706092|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.52|0.87|
71706093|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.69|
71706094|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.79|||||TWO_SIDED|95.0|0.57|1.1||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.57|
71706095|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|2.14|||||TWO_SIDED|95.0|1.52|3.02||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||3.02|1.52|
71706096|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.64|||||TWO_SIDED|95.0|1.16|2.3||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.30|1.16|
71706097|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.76|||||TWO_SIDED|95.0|0.51|1.14||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.14|0.51|
71706098|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|2.23|4.33||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.33|2.23|
71826048|NCT04771273|143156694|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0115|||||||MCPMod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0115
71764377|NCT03158285|143030596|SUPERIORITY||Difference in percentage|22.2|||<|0.001|TWO_SIDED|95.0|13.7|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|13.7|< 0.001
71764378|NCT03158285|143030597|SUPERIORITY||LS Mean difference|-0.43||||0.072|TWO_SIDED|95.0|-0.9|0.03|||ANCOVA|||||0.03|-0.90|0.072
71764379|NCT03158285|143030597|SUPERIORITY||LS Mean difference|-0.66||||0.011|TWO_SIDED|95.0|-1.13|-0.19|||ANCOVA|||||-0.19|-1.13|0.011
71764380|NCT03158285|143030598|SUPERIORITY||Difference in response rates|20.1||||0.03|TWO_SIDED|95.0|11.8|28.5|||Cochran-Mantel-Haenszel|||||28.5|11.8|0.030
71764381|NCT03158285|143030598|SUPERIORITY||Difference in response rates|14.6||||0.03|TWO_SIDED|95.0|6.4|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.4|0.030
71764382|NCT03158285|143030599|SUPERIORITY||Difference in response rates|18.0||||0.03|TWO_SIDED|95.0|7.4|28.6|||Cochran-Mantel-Haenszel|||||28.6|7.4|0.030
71764383|NCT03158285|143030599|SUPERIORITY||Difference in response rates|21.3||||0.011|TWO_SIDED|95.0|10.5|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.5|0.011
71764384|NCT03158285|143030600|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.77|-0.23||Nominal|ANCOVA|||||-0.23|-0.77|< 0.001
71764385|NCT03158285|143030600|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.31||Nominal|ANCOVA|||||-0.31|-0.83|< 0.001
71764386|NCT03158285|143030601|SUPERIORITY||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.99|-0.79||Nominal|ANCOVA|||||-0.79|-2.99|< 0.001
71764387|NCT03158285|143030601|SUPERIORITY||LS Mean Difference|-1.77||||0.002|TWO_SIDED|95.0|-2.87|-0.66||Nominal|ANCOVA|||||-0.66|-2.87|0.002
71764388|NCT03158285|143030602|SUPERIORITY||LS Mean difference|3.97||||0.011|TWO_SIDED|95.0|2.75|5.2|||ANCOVA|||||5.20|2.75|0.011
71764389|NCT03158285|143030602|SUPERIORITY||LS Mean difference|3.62||||0.011|TWO_SIDED|95.0|2.39|4.85|||ANCOVA|||||4.85|2.39|0.011
71764390|NCT03158285|143030603|SUPERIORITY||LS Mean difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.43||Nominal|ANCOVA|||||-0.43|-0.80|< 0.001
71826049|NCT04771273|143156694|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.2204|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.2204
71764391|NCT03158285|143030603|SUPERIORITY||LS Mean difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.83|-0.47||Nominal|ANCOVA|||||-0.47|-0.83|< 0.001
71764392|NCT03158285|143030604|SUPERIORITY||LS Mean difference|2.02||||0.072|TWO_SIDED|95.0|0.56|3.49|||ANCOVA|||||3.49|0.56|0.072
71764393|NCT03158285|143030604|SUPERIORITY||LS Mean difference|2.07||||0.072|TWO_SIDED|95.0|0.6|3.54|||ANCOVA|||||3.54|0.60|0.072
71764394|NCT03158285|143030605|SUPERIORITY||Difference in percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.6|25.9||Nominal|Cochran-Mantel-Haenszel|||||25.9|12.6|< 0.001
71764395|NCT03158285|143030605|SUPERIORITY||Difference in percentage|11.5|||<|0.001|TWO_SIDED|95.0|5.2|17.7||Nominal|Cochran-Mantel-Haenszel|||||17.7|5.2|< 0.001
71764396|NCT03158285|143030606|SUPERIORITY||Difference in percentage|14.5|||<|0.001|TWO_SIDED|95.0|9.1|19.9||Nominal|Cochran-Mantel-Haenszel|||||19.9|9.1|< 0.001
71764397|NCT03158285|143030606|SUPERIORITY||Difference in percentage|9.0|||<|0.001|TWO_SIDED|95.0|4.1|13.8||Nominal|Cochran-Mantel-Haenszel|||||13.8|4.1|< 0.001
71764398|NCT03060551|143030810|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.256||||||p value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.256
71764399|NCT03060551|143030811|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.682||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.682
71764400|NCT03060551|143030812|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.151||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.151
71764401|NCT03060551|143030813|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.516||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.516
71826050|NCT04771273|143156694|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71706099|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.17|0.61|
71706100|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.27|||||TWO_SIDED|95.0|0.19|0.4||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.40|0.19|
71706101|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratrio|1.82|||||TWO_SIDED|95.0|1.25|2.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.66|1.25|
71706102|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.91|1.94||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.94|0.91|
71706103|NCT01026038|142930021|SUPERIORITY_OR_OTHER||GMC ratio|0.73|||||TWO_SIDED|95.0|0.47|1.13||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.47|
71706104|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.63|||||TWO_SIDED|95.0|0.23|1.76||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.76|0.23|
71706105|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.3|1.99||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.99|0.30|
71706106|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|0.38|3.86||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.86|0.38|
71706107|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.43|1.99||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.99|0.43|
71706108|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.54|2.22||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.22|0.54|
71706109|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.79|0.50|
71706110|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.56|2.19||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.19|0.56|
71706111|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.58|2.06||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.06|0.58|
71706112|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.46|2.13||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.13|0.46|
71706113|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.38|2.55||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.55|0.38|
71706114|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.5|3.0||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.00|0.50|
71706115|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.25|||||TWO_SIDED|95.0|0.42|3.72||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.42|
71706116|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.29|1.68||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.68|0.29|
71706117|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.4|2.1||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.10|0.40|
71826051|NCT04771273|143156694|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71706118|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.33|||||TWO_SIDED|95.0|0.49|3.64||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.64|0.49|
71706119|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.7|||||TWO_SIDED|95.0|0.7|4.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.12|0.70|
71706120|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.37|||||TWO_SIDED|95.0|0.6|3.14||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.14|0.60|
71706121|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.81|||||TWO_SIDED|95.0|0.3|2.21||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.21|0.30|
71706122|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.43|1.89||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.89|0.43|
71706123|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.83|||||TWO_SIDED|95.0|0.42|1.67||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.67|0.42|
71764402|NCT03060551|143030814|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.|||||>|0.999||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||>0.999
71764403|NCT03060551|143030815|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.034||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.034
71706124|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.93|||||TWO_SIDED|95.0|0.4|2.16||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.16|0.40|
71764404|NCT03060551|143030816|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.656||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.656
71706125|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|7.53|||||TWO_SIDED|95.0|2.86|19.78||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||19.78|2.86|
71706126|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.53|||||TWO_SIDED|95.0|0.22|1.31||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.22|
71706127|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.07|||||TWO_SIDED|95.0|0.02|0.21||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.21|0.02|
71706128|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.11|||||TWO_SIDED|95.0|0.53|2.3||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||2.30|0.53|
71764405|NCT03060551|143030817|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.096||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.096
71764406|NCT03060551|143030818|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.019||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.019
71764407|NCT03060551|143030819|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.05||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.050
71826052|NCT04771273|143156694|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71764408|NCT03060551|143030820|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
71764409|NCT03060551|143030821|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.024||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.024
71764410|NCT03060551|143030822|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.188||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.188
71764411|NCT03060551|143030823|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.372||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.372
71764412|NCT03060551|143030824|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.633||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.633
71764413|NCT03060551|143030825|OTHER|Because most efficacy data consisted of non-parameteric variables, results were shown as median values and interquartile range. The Wilcoxon signed-rank test was performed to analyze differences between baseline and at 2W, 6W, 12W and 24W, respectively, using IBM-SPSS Statistics version 24.0 (SPSS Inc., Chicago, IL, USA). Statistical significance was considered at p \< 0.05. Safety profiles were descriptively analyzed.||||||0.38||||||p-value (24 weeks-baseline)|Wilcoxon (Mann-Whitney)|||||||0.380
71826053|NCT04771273|143156695|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|5.07|||<|0.0001|TWO_SIDED|95.0|2.47|10.4||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||10.40|2.47|<.0001
71826054|NCT04771273|143156695|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.36|20.51||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||20.51|4.36|<.0001
71764414|NCT00750152|143030832|SUPERIORITY_OR_OTHER||one-sided p-value from CMH test|0.001||||0.025|ONE_SIDED|95.0|||||Cochran-Mantel-Haenszel|The CMH test after stratification by site compared the proportion of complete cure in NAFT-500 to that of placebo to evaluate its superiority.||"In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~* H0: p1 \<= p0~* Ha: p1 \> p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively."||||0.025
71764415|NCT02140593|143030846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71764416|NCT02140593|143030847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71764417|NCT02034409|143030874|NON_INFERIORITY|For the 48-week OMERACT-OARSI response the minimally clinically significant difference is an absolute rate difference of 10% between sham and PLIUS groups. With a total sample size of 144 the probability of correctly selecting the group with the greatest OORR is at least 0.885 assuming (δ=10%) that the sham group is drawn from a population with a 50% response rate and the PLIUS group is drawn from a population with response rate of at least 60% or at most 40%.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
71706129|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.5|1.97||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.97|0.50|
71706130|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.39|2.07||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.07|0.39|
71706131|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|4.2|||||TWO_SIDED|95.0|2.18|8.09||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||8.09|2.18|
71706132|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.33|1.13||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.13|0.33|
71706133|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.15|||||TWO_SIDED|95.0|0.07|0.31||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.31|0.07|
71706134|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|3.11|||||TWO_SIDED|95.0|1.51|6.4||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.40|1.51|
71706135|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.88|||||TWO_SIDED|95.0|0.96|3.69||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.69|0.96|
71706136|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.6|||||TWO_SIDED|95.0|0.27|1.37||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.37|0.27|
71706137|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|2.88|||||TWO_SIDED|95.0|1.39|5.98||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.98|1.39|
71706138|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.15|||||TWO_SIDED|95.0|0.58|2.28||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.28|0.58|
71706139|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.4|||||TWO_SIDED|95.0|0.17|0.92||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.92|0.17|
71706140|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|2.57|||||TWO_SIDED|95.0|1.5|4.39||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.39|1.50|
71706141|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|1.24|||||TWO_SIDED|95.0|0.75|2.05||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.05|0.75|
71706142|NCT01026038|142930022|SUPERIORITY_OR_OTHER||GMC ratio|0.48|||||TWO_SIDED|95.0|0.26|0.89||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.89|0.26|
71706143|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.73||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.73|0.04|
71706144|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT Ratio|0.2|||||TWO_SIDED|95.0|0.04|0.64||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.64|0.04|
71706145|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.19|5.46||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.46|0.19|
71706146|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.17|5.85||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||5.85|0.17|
71706147|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.15|3.72||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.72|0.15|
71706148|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.1|5.37||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.37|0.10|
71826055|NCT04771273|143156695|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|16.09|||<|0.0001|TWO_SIDED|95.0|6.69|38.73||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||38.73|6.69|<.0001
71706149|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.25||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||6.25|0.23|
71706150|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.17|3.92||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.92|0.17|
71706151|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.11|4.43||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.43|0.11|
71706152|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|2.4|||||TWO_SIDED|95.0|0.48|12.35||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||12.35|0.48|
71706153|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.45|9.05||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.05|0.45|
71706154|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.13|5.14||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||5.14|0.13|
71706155|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.04|0.8||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.80|0.04|
71706156|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.12|2.03||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.03|0.12|
71706157|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|2.7|||||TWO_SIDED|95.0|0.48|14.92||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||14.92|0.48|
71706158|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.23|4.36||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.36|0.23|
71706159|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.31|4.84||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||4.84|0.31|
71764418|NCT02034409|143030875|NON_INFERIORITY|For the 48-week cartilage change outcome measure the minimally clinically significant difference is 33 μm. With a difference of 33 μm, σ=152 μm standard deviation, k=2 groups, and P=0.90 probability to obtain τ=1.8124, which we use to estimate the per-group sample size: n=σ2(τ/δ\*)2=72 or a total of 144.||||||||||||||||Sample size has been calculated with ranking and selection methodology, a procedure used for Phase II trials. The purpose of the procedure as applied to this study is to identify whether PLIUS has a high probability of being more effective than sham. This is accomplished by obtaining sample estimates of the outcome for the PLIUS and sham groups and determining whether the PLIUS group outcome is better by the pre-specified margin of difference.|Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue.|||
71764419|NCT03255629|143030961|OTHER|||||||0.103|||||||McNemar|||||||0.103
71764420|NCT03255629|143030962|OTHER|||||||0.18|||||||McNemar|||||||0.180
71764421|NCT03255629|143030964|OTHER|||||||0.317|||||||McNemar|||||||0.317
71764422|NCT03255629|143030965|OTHER|||||||0.008|||||||McNemar|||||||0.008
71764423|NCT03255629|143030966|OTHER|||||||0.083|||||||McNemar|||||||0.083
71764424|NCT03255629|143030967|OTHER|||||||0.025|||||||McNemar|||||||0.025
71764425|NCT03255629|143030969|OTHER|||||||0.049|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.049
71764426|NCT03255629|143030970|OTHER|||||||0.056|||||||Mixed Models Analysis|Linear mixed effects models to account for correlation within subjects over time||||||0.056
71764427|NCT03255629|143030971|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71764428|NCT03255629|143030972|OTHER|||||||0.059|||||||Mixed Models Analysis|||||||0.059
71764429|NCT03255629|143030973|OTHER|||||||0.195|||||||Mixed Models Analysis|||||||0.195
71764430|NCT03255629|143030974|OTHER|||||||0.043|||||||Mixed Models Analysis|||||||0.043
71764431|NCT03255629|143030975|OTHER|||||||0.659|||||||Mixed Models Analysis|||||||0.659
71764432|NCT03255629|143030976|OTHER|||||||0.406|||||||Mixed Models Analysis|||||||0.406
71764433|NCT03255629|143030977|OTHER|||||||0.611|||||||Mixed Models Analysis|||||||0.611
71764434|NCT03255629|143030978|OTHER|||||||0.183|||||||Mixed Models Analysis|||||||0.183
71764435|NCT03255629|143030979|OTHER|||||||0.009|||||||Mixed Models Analysis|||||||0.009
71764436|NCT03255629|143030980|OTHER|||||||0.789|||||||Mixed Models Analysis|||||||0.789
71764437|NCT03255629|143030981|OTHER|||||||0.865|||||||McNemar|||||||0.865
71764438|NCT03255629|143030982|OTHER|||||||0.875|||||||McNemar|||||||0.875
71764439|NCT01147627|143031001|NON_INFERIORITY_OR_EQUIVALENCE|108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.|||||<|0.05||95.0|||||ANCOVA|||||||<0.05
71764440|NCT02223377|143031009|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.56|1.78|||Regression, Logistic|||||1.78|0.56|0.997
71764441|NCT02223377|143031014|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.04|TWO_SIDED|95.0|-1.43|-0.03|||ANOVA|||||-0.03|-1.43|0.040
71764442|NCT01767142|143031049|OTHER||sucess proportion|83.9|||||TWO_SIDED|95.0|74.8|90.7||||||||90.7|74.8|
71826056|NCT04771273|143156695|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826057|NCT04771273|143156695|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826058|NCT04771273|143156695|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71706160|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.23|6.65||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||6.65|0.23|
71826059|NCT04771273|143156695|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826060|NCT04771273|143156695|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71886545|NCT05227690|143293399|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.26|=|0.6007|TWO_SIDED|95.0|-5.6|3.3|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||3.3|-5.6|=0.6007
71706161|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.17|4.17||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.17|0.17|
71706162|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.07|1.24||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.24|0.07|
71706163|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.3|||||TWO_SIDED|95.0|0.06|2.08||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.08|0.06|
71706164|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.79|1.97||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.97|0.79|
71764443|NCT02937584|143031074|OTHER||Geometric mean ratio to baseline|1.11||||0.0187|TWO_SIDED|95.0|1.02|1.22||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.22|1.02|0.0187
71764444|NCT02937584|143031074|OTHER||Geometric mean ratio to baseline|1.23|||<|0.0001|TWO_SIDED|95.0|1.14|1.33||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||1.33|1.14|<0.0001
71764445|NCT02937584|143031075|OTHER||Geometric mean ratio to baseline|0.75||||0.0219|TWO_SIDED|95.0|0.59|0.95||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.95|0.59|0.0219
71764446|NCT02937584|143031075|OTHER||Geometric mean ratio to baseline|0.56|||<|0.0001|TWO_SIDED|95.0|0.44|0.71||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.71|0.44|<0.0001
71764447|NCT02937584|143031076|OTHER||Geometric mean ratio to baseline|1.12||||0.0283|TWO_SIDED|95.0|1.01|1.24|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.24|1.01|0.0283
71764448|NCT02937584|143031076|OTHER||Geometric mean ratio to baseline|1.21|||<|0.0001|TWO_SIDED|95.0|1.12|1.31|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.31|1.12|<0.0001
71764449|NCT02937584|143031077|OTHER||Geometric mean ratio to baseline|0.76||||0.0304|TWO_SIDED|95.0|0.59|0.97|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.97|0.59|0.0304
71764450|NCT02937584|143031077|OTHER||Geometric mean ratio to baseline|0.55||||0.0003|TWO_SIDED|95.0|0.41|0.72|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.72|0.41|0.0003
71764451|NCT02937584|143031078|OTHER||Mean Change from Baseline|0.065||||0.1582|TWO_SIDED|95.0|-0.028|0.158|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.158|-0.028|0.1582
71764452|NCT02937584|143031078|OTHER||Mean Change from Baseline|0.151||||0.0375|TWO_SIDED|95.0|0.01|0.292|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.292|0.010|0.0375
71764453|NCT02937584|143031079|OTHER||Geometric mean ratio to baseline|0.978||||0.6176|TWO_SIDED|95.0|0.891|1.073|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.073|0.891|0.6176
71764454|NCT02937584|143031079|OTHER||Geometric mean ratio to baseline|0.938||||0.2699|TWO_SIDED|95.0|0.833|1.056|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.056|0.833|0.2699
71764455|NCT00635219|143031080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.13||0.1321|TWO_SIDED|95.0|-3.92|0.51||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.51|-3.92|0.1321
71764456|NCT00635219|143031080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1847|TWO_SIDED|95.0|-3.73|0.72||Since p-value \>0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||0.72|-3.73|0.1847
71764457|NCT00635219|143031080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.12||0.2187|TWO_SIDED|95.0|-3.59|0.82||This dose was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.82|-3.59|0.2187
71764458|NCT00635219|143031080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.14||0.0741|TWO_SIDED|95.0|-4.27|0.2||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||0.20|-4.27|0.0741
71764459|NCT00635219|143031081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|1.13||0.112|TWO_SIDED|95.0|-4.01|0.42||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.42|-4.01|0.1120
71764460|NCT00635219|143031081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.1487|TWO_SIDED|95.0|-3.85|0.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.59|-3.85|0.1487
71764461|NCT00635219|143031081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.12||0.3246|TWO_SIDED|95.0|-3.31|1.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.10|-3.31|0.3246
71764462|NCT00635219|143031081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|1.13||0.0298|TWO_SIDED|95.0|-4.7|-0.24||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||-0.24|-4.70|0.0298
71764463|NCT00635219|143031082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.137|TWO_SIDED|95.0|0.9|2.23||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.23|0.90|0.1370
71764464|NCT00635219|143031082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.0664|TWO_SIDED|95.0|0.97|2.43||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.43|0.97|0.0664
71764465|NCT00635219|143031082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.2023|TWO_SIDED|95.0|0.85|2.12||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.12|0.85|0.2023
71764466|NCT00635219|143031082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0765|TWO_SIDED|95.0|0.96|2.4||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||2.40|0.96|0.0765
71764467|NCT00635219|143031083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1436|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1436
71764468|NCT00635219|143031083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2114|TWO_SIDED|95.0|-0.44|0.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.10|-0.44|0.2114
71764469|NCT00635219|143031083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1389|TWO_SIDED|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.07|-0.47|0.1389
71826061|NCT04771273|143156695|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71706165|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.38|0.88||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.88|0.38|
71826062|NCT04771273|143156696|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|10.39|||<|0.0001|TWO_SIDED|95.0|4.6|23.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||23.45|4.60|<.0001
71826063|NCT04771273|143156696|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|12.06|||<|0.0001|TWO_SIDED|95.0|5.3|27.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||27.45|5.30|<.0001
71826064|NCT04771273|143156696|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.5||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type, baseline liver fat content and baseline fibrosis score. Firth's penalized regression was used.||18.50|3.66|<.0001
71764470|NCT00635219|143031083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1271|TWO_SIDED|95.0|-0.48|0.06||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.06|-0.48|0.1271
71706166|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.27|0.77||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.77|0.27|
71706167|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|0.85|4.9||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.90|0.85|
71706168|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.49|2.48||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.48|0.49|
71706169|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.2|1.45||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.45|0.20|
71706170|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.87|
71706171|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.79|
71706172|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.76|1.06||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.76|
71764471|NCT00635219|143031084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4421|TWO_SIDED|95.0|-4.08|1.79||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.79|-4.08|0.4421
71706173|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|16.5|||||TWO_SIDED|95.0|3.56|76.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||76.14|3.56|
71706174|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|2.3|||||TWO_SIDED|95.0|0.56|9.06||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||9.06|0.56|
71706175|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.78||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.02|
71706176|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.22|7.07||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||7.07|0.22|
71706177|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.03|0.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.74|0.03|
71764472|NCT00635219|143031084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.49||0.4399|TWO_SIDED|95.0|-4.07|1.77||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.77|-4.07|0.4399
71764473|NCT00635219|143031084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|1.54||0.8093|TWO_SIDED|95.0|-2.65|3.4||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||3.40|-2.65|0.8093
71706178|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.1|||||TWO_SIDED|95.0|0.02|0.84||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.84|0.02|
71706179|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|4.8|||||TWO_SIDED|95.0|1.35|16.98||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||16.98|1.35|
71706180|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.28|3.23||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||3.23|0.28|
71764474|NCT00635219|143031084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.53||0.0897|TWO_SIDED|95.0|-5.61|0.41||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.41|-5.61|0.0897
71764475|NCT00635219|143031085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.98||0.6748|TWO_SIDED|95.0|-2.35|1.52||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.52|-2.35|0.6748
71764476|NCT00635219|143031085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.99||0.0871|TWO_SIDED|95.0|-3.64|0.25||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.25|-3.64|0.0871
71764477|NCT00635219|143031085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|0.99||0.3186|TWO_SIDED|95.0|-2.94|0.96||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.96|-2.94|0.3186
71764478|NCT00635219|143031085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.01||0.0768|TWO_SIDED|95.0|-3.79|0.19||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.19|-3.79|0.0768
71764479|NCT00635219|143031086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6258|TWO_SIDED|95.0|0.7|1.81||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.81|0.70|0.6258
71764480|NCT00635219|143031086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7178|TWO_SIDED|95.0|0.68|1.76||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.76|0.68|0.7178
71764481|NCT00635219|143031086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8651|TWO_SIDED|95.0|0.59|1.55||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.55|0.59|0.8651
71764482|NCT00635219|143031086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8563|TWO_SIDED|95.0|0.65|1.69||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.|||1.69|0.65|0.8563
71764483|NCT00635219|143031087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.86||0.1925|TWO_SIDED|95.0|-2.82|0.57||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.57|-2.82|0.1925
71706181|NCT01026038|142930023|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.05|0.85||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.85|0.05|
71706182|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.38||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.38|0.80|
71706183|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.76|
71764484|NCT00635219|143031087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.87||0.2434|TWO_SIDED|95.0|-2.72|0.69||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.69|-2.72|0.2434
71764485|NCT00635219|143031087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86||0.7246|TWO_SIDED|95.0|-2.0|1.39||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.39|-2.00|0.7246
71764486|NCT00635219|143031087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.87||0.0981|TWO_SIDED|95.0|-3.16|0.27||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.27|-3.16|0.0981
71764487|NCT00635219|143031088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2285|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2285
71764488|NCT00635219|143031088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1794|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1794
71764489|NCT00635219|143031088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1741|TWO_SIDED|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.09|-0.48|0.1741
71764490|NCT00635219|143031088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2247|TWO_SIDED|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||0.11|-0.46|0.2247
71764491|NCT00635219|143031089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.86||0.7789|TWO_SIDED|95.0|-1.93|1.45||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.45|-1.93|0.7789
71764492|NCT00635219|143031089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.87||0.8121|TWO_SIDED|95.0|-1.91|1.5||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.50|-1.91|0.8121
71764493|NCT00635219|143031089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.87||0.8918|TWO_SIDED|95.0|-1.82|1.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.59|-1.82|0.8918
71764494|NCT00635219|143031089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.69|1.75||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.|||1.75|-1.69|0.9720
71653926|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.0041|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.21|-1.13|0.0041
71653927|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0024|TWO_SIDED|95.0|-1.19|-0.26|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.26|-1.19|0.0024
71653928|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.24||0.0015|TWO_SIDED|95.0|-1.22|-0.29|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.29|-1.22|0.0015
71653929|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.25||0.0063|TWO_SIDED|95.0|-1.16|-0.19|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.19|-1.16|0.0063
71653930|NCT02697773|142825044|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.24||0.0008|TWO_SIDED|95.0|-1.3|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.||-0.34|-1.30|0.0008
71653931|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.61|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.61|-1.47|<.0001
71653932|NCT02697773|142825046|SUPERIORITY||Least Mean Square Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.62|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.62|-1.47|<.0001
71653933|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.67|-0.81|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.81|-1.67|<.0001
71706184|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.30|0.69|
71706185|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.49|0.9||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.90|0.49|
71706186|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.55|1.01||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.01|0.55|
71706187|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.79|1.59||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.59|0.79|
71706188|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.3|||||TWO_SIDED|95.0|0.98|1.63||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.63|0.98|
71706189|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.76|1.27||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.27|0.76|
71706190|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.05||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.05|0.58|
71706191|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.21|0.67|
71764495|NCT04075734|143031102|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.59
71653934|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.80|-1.66|<.0001
71653935|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.0007|TWO_SIDED|95.0|-1.25|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.33|-1.25|0.0007
71653936|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.23||0.0013|TWO_SIDED|95.0|-1.2|-0.29|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-1.20|0.0013
71653937|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.51|-0.55|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.55|-1.51|<.0001
71653938|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.67|-0.73|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.73|-1.67|<.0001
71653939|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.25||0.0007|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0007
71653940|NCT02697773|142825046|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.48|-0.51|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.48|<.0001
71653941|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.22|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.22|<.0001
71653942|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.29|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.48|-1.29|<.0001
71653943|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.46|-0.63|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.63|-1.46|<.0001
71706192|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.25||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.25|0.70|
71706193|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.73|1.46||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.46|0.73|
71706194|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.83|1.43||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.43|0.83|
71706195|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.20|0.70|
71706196|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.61|1.15||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.15|0.61|
71706197|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.51|1.15||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.15|0.51|
71826065|NCT04771273|143156696|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod linear model fit|Linear model fit assumption.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71653944|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.49|-0.66|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.66|-1.49|<.0001
71653945|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.22||0.0024|TWO_SIDED|95.0|-1.12|-0.24|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.12|0.0024
71653946|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0078|TWO_SIDED|95.0|-1.03|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.03|0.0078
71653947|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.35|-0.43|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-1.35|0.0002
71653948|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.5|-0.57|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.57|-1.50|<.0001
71653949|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0034|TWO_SIDED|95.0|-1.16|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.16|0.0034
71653950|NCT02697773|142825048|SUPERIORITY||Least Square Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.33|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.33|0.0003
71653951|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.0026|TWO_SIDED|95.0|-1.1|-0.23|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-1.10|0.0026
71653952|NCT02697773|142825050|SUPERIORITY||Least Mean Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.22||0.0023|TWO_SIDED|95.0|-1.1|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.24|-1.10|0.0023
71653953|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.40|-1.29|0.0002
71653954|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.35|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.47|-1.35|<.0001
71706198|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.7|||||TWO_SIDED|95.0|0.46|1.03||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.03|0.46|
71706199|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.56|1.44||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.44|0.56|
71706200|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.37||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.37|0.74|
71706201|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.67|1.23||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.23|0.67|
71706202|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.29||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.29|0.63|
71706203|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|3.1|||||TWO_SIDED|95.0|2.4|4.06||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||4.06|2.40|
71706204|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.66|0.39|
71706205|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.2|||||TWO_SIDED|95.0|0.12|0.22||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.22|0.12|
71706206|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.4|||||TWO_SIDED|95.0|1.11|1.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.78|1.11|
71706207|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.66|1.06||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.06|0.66|
71706208|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.78|0.45|
71706209|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.2|||||TWO_SIDED|95.0|0.84|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.62|0.84|
71706210|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.6|||||TWO_SIDED|95.0|0.45|0.87||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.87|0.45|
71706211|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.36|0.79||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||0.79|0.36|
71706212|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.71|1.4||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.40|0.71|
71706213|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.66|1.31||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.31|0.66|
71706214|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.9|||||TWO_SIDED|95.0|0.63|1.39||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.39|0.63|
71764496|NCT04075734|143031102|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.003
71764497|NCT04075734|143031103|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
71764498|NCT04075734|143031104|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.07
71764499|NCT04075734|143031105|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.2
71764500|NCT04075734|143031106|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.006
71764501|NCT04075734|143031107|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.86
71764502|NCT04075734|143031108|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
71764503|NCT04075734|143031109|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of intervention over time.||||||0.02
71764504|NCT04075734|143031110|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.29
71826066|NCT04771273|143156696|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0031|||||||MCP-Mod exponential-1 model fit|Model assumption: 25% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0031
71826067|NCT04771273|143156696|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."||||||0.0925|||||||MCP-Mod exponential-2 model fit|Model assumption: 5% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||0.0925
71826068|NCT04771273|143156696|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71886546|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.061|=|0.5822|TWO_SIDED|95.0|-0.15|0.09|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 1-- Emraclidine 30 mg versus Placebo||0.09|-0.15|=0.5822
71764505|NCT04075734|143031111|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.13
71764506|NCT04075734|143031112|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.14
71764507|NCT04075734|143031113|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|A linear mixed model for repeat measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.03
71764508|NCT04075734|143031114|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.66
71764509|NCT04075734|143031115|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|A linear mixed model for repeated measures was used. The group x time interaction evaluated the effect of the intervention over time.||||||0.15
71764510|NCT03615040|143031129|SUPERIORITY||Incidence Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.15||0.195|TWO_SIDED|95.0|0.53|1.14|||t-test, 2 sided|||A generalised linear model (assuming neg. binomial distribution) was used. The model includes the number of exacerbations during the 48 week treatment as an outcome with explanatory variables of treatment arm \& number of exacerbations in the 12 months prior to the trial (stratification factor), and log-time on trial (in weeks) as an offset. The offset, allows for different lengths of time in the trial. Only observed exacerbations were used alongside the corresponding time period in the offset.||1.14|0.53|0.195
71764511|NCT03615040|143031132|SUPERIORITY||Mean Difference (Net)|-3.3||||0.039|TWO_SIDED|95.0|-6.4|-0.2|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||-0.2|-6.4|0.039
71764512|NCT03615040|143031133|SUPERIORITY||Mean Difference (Net)|0.53||||0.469|TWO_SIDED|95.0|-0.91|2.0|||Mixed Models Analysis|||Calculated using mixed effect linear model with dependent variable of the outcome at baseline and follow-up time points (Week 4, 12, 24, 36, 48); explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score; an interaction term between treatment and visit as fixed effects; and patient identification as a random effect.||2.00|-0.91|0.469
71764513|NCT03615040|143031134|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 4||||0.90
71764514|NCT03615040|143031134|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 12||||0.95
71764515|NCT03615040|143031134|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 24||||0.78
71764516|NCT03615040|143031134|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 36||||0.88
71764517|NCT03615040|143031134|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank sum test of mMRC dyspnoea Week 48||||0.78
71653955|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.0066|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.11|0.0066
71653956|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.1506|TWO_SIDED|95.0|-0.79|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.79|0.1506
71653957|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0021|TWO_SIDED|95.0|-1.25|-0.28|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.28|-1.25|0.0021
71653958|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.25||0.0008|TWO_SIDED|95.0|-1.32|-0.35|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.35|-1.32|0.0008
71653959|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.0167|TWO_SIDED|95.0|-1.09|-0.11|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-1.09|0.0167
71653960|NCT02697773|142825050|SUPERIORITY||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073|TWO_SIDED|95.0|-1.17|-0.18|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.17|0.0073
71653961|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.23||0.0058|TWO_SIDED|95.0|-1.09|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.18|-1.09|0.0058
71653962|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.23||0.0002|TWO_SIDED|95.0|-1.31|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.41|-1.31|0.0002
71653963|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.44|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.51|-1.44|<.0001
71653964|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.56|-0.64|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.64|-1.56|<.0001
71706215|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.5|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||0.70|0.41|
71706216|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.82|1.38||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.38|0.82|
71706217|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|2.0|||||TWO_SIDED|95.0|1.46|2.69||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||2.69|1.46|
71706218|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|1.0|||||TWO_SIDED|95.0|0.74|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).||1.28|0.74|
71706219|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.59|1.02||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.02|0.59|
71764518|NCT03615040|143031135|SUPERIORITY||Mean Difference (Net)|-9.4||||0.236|TWO_SIDED|95.0|-24.9|6.2||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS total||6.2|-24.9|0.236
71706220|NCT01026038|142930024|SUPERIORITY_OR_OTHER||GMT ratio|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).||1.10|0.58|
71706221|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
71706222|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71706223|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
71706224|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
71706225|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
71706226|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.4|
71706227|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
71706228|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71706229|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
71764519|NCT03615040|143031135|SUPERIORITY||Mean Difference (Net)|-4.9||||0.083|TWO_SIDED|95.0|-10.6|0.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Dyspnoea||0.7|-10.6|0.083
71764520|NCT03615040|143031135|SUPERIORITY||Mean Difference (Net)|-2.1||||0.546|TWO_SIDED|95.0|-8.9|4.7||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Cough||4.7|-8.9|0.546
71764521|NCT03615040|143031135|SUPERIORITY||Mean Difference (Net)|-1.9||||0.527|TWO_SIDED|95.0|-7.8|4.0||Using mixed effect linear model with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and baseline score as fixed effects.|Mixed Models Analysis|||VAS Sputum production||4.0|-7.8|0.527
71764522|NCT03615040|143031136|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 12||||0.84
71764523|NCT03615040|143031136|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 24||||0.52
71764524|NCT03615040|143031136|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 36||||0.82
71764525|NCT03615040|143031136|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||sputum purulence colour card Week 48||||0.95
71764526|NCT03615040|143031137|SUPERIORITY||Mean Difference (Final Values)|9.06||||0.069|TWO_SIDED|95.0|-0.83|18.97|||ANCOVA|||Pre BD FEV1/FVC ratio: Analysis of covariance (ANCOVA) adjusting for the baseline value||18.97|-0.83|0.069
71886547|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.061|=|0.9244|TWO_SIDED|95.0|-0.11|0.13|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 1-- Emraclidine 10 mg versus Placebo||0.13|-0.11|=0.9244
71706230|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.6||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.7|
71706231|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.7|
71886548|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088|=|0.9348|TWO_SIDED|95.0|-0.17|0.18|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 2-- Emraclidine 30 mg versus Placebo||0.18|-0.17|=0.9348
71653965|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.0091|TWO_SIDED|95.0|-1.11|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-1.11|0.0091
71653966|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.24||0.0668|TWO_SIDED|95.0|-0.92|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.92|0.0668
71706232|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
71653967|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.26||0.0011|TWO_SIDED|95.0|-1.36|-0.34|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.34|-1.36|0.0011
71653968|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.26||0.0002|TWO_SIDED|95.0|-1.48|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.46|-1.48|0.0002
71653969|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0059|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-1.20|0.0059
71653970|NCT02697773|142825052|SUPERIORITY||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.25||0.0005|TWO_SIDED|95.0|-1.39|-0.39|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.39|-1.39|0.0005
71653971|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|1.56||0.6984|TWO_SIDED|95.0|-2.48|3.7|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||3.70|-2.48|0.6984
71653972|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|1.6||0.2953|TWO_SIDED|95.0|-4.84|1.48|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||1.48|-4.84|0.2953
71653973|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|4.14||0.1911|TWO_SIDED|95.0|-13.59|2.74|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.74|-13.59|0.1911
71653974|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-5.59|STANDARD_ERROR_OF_MEAN|4.2||0.1857|TWO_SIDED|95.0|-13.89|2.71|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.71|-13.89|0.1857
71653975|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|4.21||0.1707|TWO_SIDED|95.0|-14.12|2.52|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.52|-14.12|0.1707
71706233|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
71706234|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.3||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.7|
71653976|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|4.29||0.138|TWO_SIDED|95.0|-14.85|2.07|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||2.07|-14.85|0.1380
71653977|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|2.42||0.1151|TWO_SIDED|95.0|-8.58|0.94|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.94|-8.58|0.1151
71653978|NCT02697773|142825055|SUPERIORITY||Least Square Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|2.41||0.1195|TWO_SIDED|95.0|-8.51|0.98|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.||0.98|-8.51|0.1195
71653979|NCT02697773|142825066|SUPERIORITY||Odds Ratio (OR)|0.48||||0.1444|TWO_SIDED|95.0|0.18|1.29|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.18|0.1444
71653980|NCT02697773|142825066|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0335|TWO_SIDED|95.0|0.09|0.91|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.91|0.09|0.0335
71653981|NCT02697773|142825067|SUPERIORITY|||||||0.0809||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0809
71653982|NCT02697773|142825067|SUPERIORITY|||||||0.0239||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0239
71653983|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.7||||0.0761|TWO_SIDED|95.0|0.48|1.04|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.04|0.48|0.0761
71653984|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.96|0.44|0.0312
71653985|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0262|TWO_SIDED|95.0|0.45|0.95|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.95|0.45|0.0262
71653986|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.54||||0.0013|TWO_SIDED|95.0|0.37|0.79|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||0.79|0.37|0.0013
71653987|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6706|TWO_SIDED|95.0|0.64|1.33|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.64|0.6706
71653988|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.69|1.43|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.43|0.69|0.9720
71653989|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.89||||0.5311|TWO_SIDED|95.0|0.61|1.29|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.29|0.61|0.5311
71764527|NCT03615040|143031138|SUPERIORITY||Mean Difference (Net)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.09|||Mixed Models Analysis|||mixed effect linear model with explanatory variables of treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), visit time point (as categorical variable), baseline score and patient identification as a random effect to account for repeated measures over time was fitted for each outcome. Adjusted mean difference between treatment arms with 95% confidence interval and p-value were reported. In the modified ITT population.||0.09|-0.01|0.094
71764528|NCT03615040|143031139|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.905|TWO_SIDED|95.0|-0.46|0.52||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Total Lung Capacity||0.52|-0.46|0.905
71764529|NCT03615040|143031139|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.775|TWO_SIDED|95.0|-0.62|0.47||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume||0.47|-0.62|0.775
71653990|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.77||||0.1712|TWO_SIDED|95.0|0.53|1.12|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.12|0.53|0.1712
71826069|NCT04771273|143156696|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod Emax2 model fit|Model assumption: 80% of maximum effect is achieved at dose 3.0 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71653991|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7475|TWO_SIDED|95.0|0.73|1.54|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.54|0.73|0.7475
71764530|NCT03615040|143031140|SUPERIORITY||Geometric mean ratio|1.01||||0.736|TWO_SIDED|95.0|0.95|1.07||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||White blood cell count||1.07|0.95|0.736
71764531|NCT03615040|143031140|SUPERIORITY||Geometric mean ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.51|0.69||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Eosinophil Count||0.69|0.51|<0.001
71764532|NCT03615040|143031140|SUPERIORITY||Geometric mean ratio|1.02||||0.678|TWO_SIDED|95.0|0.93|1.13||"Outcome was log transformed~Explanatory variables:~treatment arm, number of exacerbations in the 12 months prior to the trial (stratification factor), log BL value, visit time point (categorical) and patient identification (random effect)."|Mixed Models Analysis|||Neutrophil Count||1.13|0.93|0.678
71764533|NCT03615040|143031141|SUPERIORITY||Geometric mean ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.19|0.33||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Eosinophil count||0.33|0.19|<0.001
71764534|NCT03615040|143031157|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.362|TWO_SIDED|95.0|-0.14|0.35|||ANCOVA|||Pre BD FVC (litres): Analysis of covariance (ANCOVA) adjusting for the baseline value||0.35|-0.14|0.362
71764535|NCT03615040|143031157|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.713|TWO_SIDED|95.0|-0.61|0.44|||ANCOVA|||Pre BD FVC (litre):Analysis of covariance (ANCOVA) adjusting for the baseline value||0.44|-0.61|0.713
71764536|NCT03615040|143031158|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.711|TWO_SIDED|95.0|-8.63|12.2|||ANCOVA|||Pre FEV1 predicted: Analysis of covariance (ANCOVA) adjusting for the baseline value||12.20|-8.63|0.711
71764537|NCT03615040|143031158|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.214|TWO_SIDED|95.0|-27.9|7.1|||ANCOVA|||Pre BD FVC predicted (%): Analysis of covariance (ANCOVA) adjusting for the baseline value||7.1|-27.9|0.214
71764538|NCT03615040|143031159|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.201|TWO_SIDED|95.0|-7.53|1.65||To compare change from baseline to 48 weeks (pre and post treatment measurements), analysis of covariance (ANCOVA) model with baseline value as a covariate was fitted. Adjusted mean difference with 95% confidence interval and p-value were reported.|ANCOVA|||Residual Volume/Total Lung Capacity ratio.||1.65|-7.53|0.201
71764539|NCT03615040|143031160|SUPERIORITY||Geometric mean ratio|0.75||||0.114|TWO_SIDED|95.0|0.52|1.07||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects|Mixed Models Analysis|||Macrophage count||1.07|0.52|0.114
71653992|NCT02697773|142825068|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6564|TWO_SIDED|95.0|0.63|1.33|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.||1.33|0.63|0.6564
71653993|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.11||0.4833|TWO_SIDED|95.0|0.73|1.16|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.16|0.73|0.4833
71653994|NCT02697773|142825070|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.1||0.0942|TWO_SIDED|95.0|0.65|1.03|||Negative binomial model|||||1.03|0.65|0.0942
71653995|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.12||0.3371|TWO_SIDED|95.0|0.67|1.15|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.67|0.3371
71653996|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.11||0.0508|TWO_SIDED|95.0|0.58|1.0|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.00|0.58|0.0508
71653997|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.14||0.728|TWO_SIDED|95.0|0.71|1.27|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.71|0.7280
71886549|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.089|=|0.716|TWO_SIDED|95.0|-0.21|0.14|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 2-- Emraclidine 10 mg versus Placebo||0.14|-0.21|=0.7160
71653998|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3244|TWO_SIDED|95.0|0.65|1.15|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.15|0.65|0.3244
71706235|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.4||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-6.6|
71653999|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.16||0.5681|TWO_SIDED|95.0|0.65|1.27|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.27|0.65|0.5681
71654000|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.13||0.1387|TWO_SIDED|95.0|0.55|1.09|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.09|0.55|0.1387
71654001|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.18||0.7275|TWO_SIDED|95.0|0.76|1.48|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.48|0.76|0.7275
71654002|NCT02697773|142825070|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|0.67|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.31|0.67|0.7090
71654003|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.25||0.9164|TWO_SIDED|95.0|0.58|1.62|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.62|0.58|0.9164
71654004|NCT02697773|142825072|SUPERIORITY|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.2||0.3542|TWO_SIDED|95.0|0.47|1.31|||Negative binomial model|||||1.31|0.47|0.3542
71654005|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.28||0.8065|TWO_SIDED|95.0|0.51|1.68|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.68|0.51|0.8065
71654006|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.2||0.1752|TWO_SIDED|95.0|0.36|1.2|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.20|0.36|0.1752
71654007|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.7837|TWO_SIDED|95.0|0.48|1.73|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.73|0.48|0.7837
71654008|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.81|STANDARD_ERROR_OF_MEAN|0.26||0.5062|TWO_SIDED|95.0|0.43|1.52|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.52|0.43|0.5062
71654009|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.6821|TWO_SIDED|95.0|0.4|1.82|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.82|0.40|0.6821
71706236|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|-1.7|||||TWO_SIDED|95.0|-6.2|4.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-6.2|
71706237|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.1|||||TWO_SIDED|95.0|-4.8|7.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||7.5|-4.8|
71706238|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-4.8|9.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||9.5|-4.8|
71886550|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|=|0.6883|TWO_SIDED|95.0|-0.24|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.16|-0.24|=0.6883
71654010|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.3||0.5032|TWO_SIDED|95.0|0.36|1.65|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||1.65|0.36|0.5032
71654011|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|1.24|STANDARD_ERROR_OF_MEAN|0.47||0.5796|TWO_SIDED|95.0|0.58|2.61|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.61|0.58|0.5796
71654012|NCT02697773|142825072|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.36||0.8725|TWO_SIDED|95.0|0.44|2.0|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.||2.00|0.44|0.8725
71654013|NCT00842530|142825090|SUPERIORITY|The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|30.2|||||TWO_SIDED|95.0|-13.4|56.6||||||Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.||56.6|-13.4|
71654014|NCT00842530|142825091|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|75.2|||||TWO_SIDED|95.0|-377.0|99.6||||||Vaccine efficacy against severe VCD (IDMC)||99.6|-377|
71654015|NCT00842530|142825091|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|50.3|||||TWO_SIDED|95.0|-585.0|96.4||||||Vaccine efficacy of against severe VCD (WHO 1999)||96.4|-585|
71654016|NCT00842530|142825092|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|41.5|||||TWO_SIDED|95.0|-38.4|74.9||||||Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 3||74.9|-38.4|
71654017|NCT00842530|142825092|SUPERIORITY|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|35.3|||||TWO_SIDED|95.0|3.3|56.5||||||Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase||56.5|3.3|
71654018|NCT00842530|142825098|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|33.4|||||TWO_SIDED|95.0|4.1|53.5||||||Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase||53.5|4.1|
71654019|NCT00842530|142825098|OTHER|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|34.9|||||TWO_SIDED|95.0|6.7|54.3||||||Vaccine efficacy: Day 0 up to end of Active Phase||54.3|6.7|
71706239|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.7||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.5|
71706240|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
71764540|NCT03615040|143031161|SUPERIORITY||Geometric mean ratio|0.79||||0.215|TWO_SIDED|95.0|0.54|1.15||A mixed effect linear model of the log outcome with explanatory variables treatment, number of exacerbations in the 12 months prior to the trial (stratification), visit time point (as categorical variable) and log baseline score as fixed effects.|Mixed Models Analysis|||Epithelium count||1.15|0.54|0.215
71764541|NCT01776307|143031164|OTHER|Descriptive analysis for investigational arms; no comparator analysis|||||||||||||||||The exact 95% confidence interval is based on the Clopper-Pearson method.|||
71764542|NCT01776307|143031165|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
71764543|NCT01776307|143031166|OTHER|Estimates provided for investigational arms; no comparator analysis|||||||||||||||||Estimated from Kaplan Meier Curve|||
71826070|NCT04771273|143156696|OTHER|"Logistic regression estimates were used as input for the MCP-Mod. The logistic regression model was fitted without an intercept, and included presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\] and the dose group as factors, and baseline liver fat content (assessed by MRI-PDFF) as a continuous linear covariate.~P-values from the contrast tests corresponding to each dose response pattern evaluated were adjusted for the multiple comparisons performed."|||||<|0.0001|||||||MCP-Mod quadratic model fit|Model assumption: Maximum effect is achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of survodutide and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 6 different plausible dose-response patterns (linear, exponential1, exponential2, Emax1, Emax2, quadratic) while keeping full control of the type I error (one-sided alpha of 0.050).||||<0.0001
71826071|NCT04771273|143156697|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-8.59|||<|0.0001|TWO_SIDED|95.0|-10.59|-6.6||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-6.60|-10.59|<.0001
71826072|NCT04771273|143156697|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.91|||<|0.0001|TWO_SIDED|95.0|-12.96|-8.86||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.86|-12.96|<.0001
71826073|NCT04771273|143156697|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-11.07|||<|0.0001|TWO_SIDED|95.0|-13.23|-8.92||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.92|-13.23|<.0001
71826074|NCT04771273|143156698|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-9.12|||<|0.0001|TWO_SIDED|95.0|-11.21|-7.03||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-7.03|-11.21|<.0001
71706241|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.7|6.5||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-6.7|
71706242|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.4||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.5|
71706243|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-3.6|
71706244|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.3|-6.5|
71706245|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|1.8|||||TWO_SIDED|95.0|-1.7|9.6||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||9.6|-1.7|
71706246|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.7|6.2||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.2|-3.7|
71706247|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|-1.8|||||TWO_SIDED|95.0|-9.6|4.5||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||4.5|-9.6|
71706248|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-2.0|11.3||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||11.3|-2.0|
71706249|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.9|5.6||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||5.6|-4.9|
71886551|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.5973|TWO_SIDED|95.0|-0.14|0.25|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.25|-0.14|=0.5973
71654020|NCT00486018|142825107|SUPERIORITY_OR_OTHER||Difference in Least Squares means|9.4|||<|0.0001||95.0|6.6|12.2||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||12.2|6.6|<0.0001
71654021|NCT00486018|142825107|SUPERIORITY_OR_OTHER||Difference in Least Squares means|10.6|||<|0.0001||95.0|7.6|13.6||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||13.6|7.6|<0.0001
71654022|NCT00486018|142825108|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001||95.0|15.6|38.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||38.0|15.6|<0.0001
71654023|NCT00486018|142825108|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001||95.0|20.1|42.6|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||42.6|20.1|<0.0001
71654024|NCT00486018|142825109|SUPERIORITY_OR_OTHER||Difference in percentage|4.5||||0.0141||95.0|1.6|9.9|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||9.9|1.6|0.0141
71654025|NCT00486018|142825109|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.2815||95.0|-1.5|8.3|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.|||8.3|-1.5|0.2815
71654026|NCT00486018|142825110|SUPERIORITY_OR_OTHER||Difference in percentage|45.5|||<|0.0001||95.0|36.0|55.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||55.0|36.0|<0.0001
71654027|NCT00486018|142825110|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001||95.0|29.9|50.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||50.2|29.9|<0.0001
71654028|NCT00486018|142825111|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-148.7|||<|0.0001||95.0|-183.6|-113.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-113.8|-183.6|<0.0001
71654029|NCT00486018|142825111|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-134.8|||<|0.0001||95.0|-172.7|-96.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-96.8|-172.7|<0.0001
71654030|NCT00486018|142825112|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0214||95.0|0.6|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||7.6|0.6|0.0214
71654031|NCT00486018|142825112|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.4||||0.0002||95.0|3.0|9.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.8|3.0|0.0002
71654032|NCT00486018|142825113|SUPERIORITY_OR_OTHER||Difference in Least Squares means|3.8||||0.0248||95.0|0.5|7.0|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.0|0.5|0.0248
71654033|NCT00486018|142825113|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.1||||0.0014||95.0|2.0|8.3|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||8.3|2.0|0.0014
71654034|NCT02243293|142825115|NON_INFERIORITY|The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|98.5|||||TWO_SIDED|95.0|96.5|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|||100.0|96.5|
71654035|NCT02409329|142825132|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.313||||0.0493|TWO_SIDED|95.0|-0.61|-0.017||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||-0.017|-0.610|.0493
71706250|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|-3.6|||||TWO_SIDED|95.0|-12.5|3.2||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||3.2|-12.5|
71654036|NCT02409329|142825132|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.07||||0.26|TWO_SIDED|95.0|-0.38|0.24||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.240|-0.380|0.260
71654037|NCT02409329|142825133|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.406|||<|0.001|TWO_SIDED|95.0|0.196|0.615||A priori threshold p\<.05.|Wald statistic|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.615|0.196|<.001
71654038|NCT02409329|142825133|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.21||||0.003|TWO_SIDED|95.0|-0.031|0.45||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. For the HbA1c model, we allowed for a three-way interaction between time, treatment group, and baseline HbA1c because there was descriptive evidence that the effect was modified by baseline HbA1c values. Multiply imputed data (m=1,000) using chained equations.||0.450|-0.031|0.003
71654039|NCT02409329|142825134|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.54||||0.376|TWO_SIDED|95.0|-0.012|1.09||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.090|-0.012|0.376
71654040|NCT02409329|142825134|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.278||||0.434|TWO_SIDED|95.0|-0.319|0.875||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.875|-0.319|0.434
71654041|NCT02409329|142825135|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.399||||0.0012|TWO_SIDED|95.0|0.16|0.637||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations||0.637|0.160|0.0012
71706251|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71706252|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.5|-3.6|
71706253|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.6|6.6||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.6|
71706254|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.4||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.4|-3.6|
71764544|NCT04074161|143031191|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.|Treatment difference|-9.38|||<|0.0001|TWO_SIDED|95.0|-11.97|-6.8|||ANCOVA|||||-6.80|-11.97|<0.0001
71826075|NCT04771273|143156698|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.79|||<|0.0001|TWO_SIDED|95.0|-12.85|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-12.85|<.0001
71826076|NCT04771273|143156698|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-10.86|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.73||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg - Placebo."|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-8.73|-13.00|<.0001
71826077|NCT04771273|143156699|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-43.64|||<|0.0001|TWO_SIDED|95.0|-53.49|-33.79||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-33.79|-53.49|<.0001
71826078|NCT04771273|143156699|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.52|||<|0.0001|TWO_SIDED|95.0|-65.61|-45.42||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.42|-65.61|<.0001
71826079|NCT04771273|143156699|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-57.02|||<|0.0001|TWO_SIDED|95.0|-67.66|-46.39||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-46.39|-67.66|<.0001
71826080|NCT04771273|143156700|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-46.49|||<|0.0001|TWO_SIDED|95.0|-56.74|-36.25||The p-value reported is considered nominal.|MMRM||"Survodutide 2.4 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-36.25|-56.74|<.0001
71826081|NCT04771273|143156700|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-55.11|||<|0.0001|TWO_SIDED|95.0|-65.25|-44.98||The p-value reported is considered nominal.|MMRM||"Survodutide 4.8 mg - Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-44.98|-65.25|<.0001
71826082|NCT04771273|143156700|OTHER|No confirmatory hypothesis testing was performed.|Mean Difference (Net)|-56.26|||<|0.0001|TWO_SIDED|95.0|-66.76|-45.77||The p-value reported is considered nominal.|MMRM||"Survodutide 6.0 mg-Placebo"|Least Squares Mean differences and 95% confidence interval were calculated from mixed-effect model for repeated measures (MMRM) including fixed effects for baseline liver fat content (%) as a continuous linear covariate, and treatment, presence of diabetes of any type \[yes, no\], baseline fibrosis score \[F1, F2, F3\], visit, treatment by visit interaction and baseline by visit interaction as factors.||-45.77|-66.76|<.0001
71826083|NCT04771273|143156701|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|1.61||||0.1894|TWO_SIDED|95.0|0.79|3.26||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||3.26|0.79|0.1894
71826084|NCT04771273|143156701|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.0||||0.0685|TWO_SIDED|95.0|0.95|4.2||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.20|0.95|0.0685
71886552|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11|=|0.1392|TWO_SIDED|95.0|-0.38|0.05|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 4-- Emraclidine 30 mg versus Placebo||0.05|-0.38|=0.1392
71706255|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.5|6.6||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.5|
71654042|NCT02409329|142825135|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.152||||0.003|TWO_SIDED|95.0|-0.121|0.426||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.426|-0.121|0.003
71654043|NCT02409329|142825136|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.061||||0.632|TWO_SIDED|95.0|-0.218|0.095||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.095|-0.218|0.632
71654044|NCT02409329|142825136|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|0.005||||0.572|TWO_SIDED|95.0|-0.202|1.1||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||1.100|-0.202|0.572
71654045|NCT02409329|142825137|SUPERIORITY|We performed an omnibus test of the treatment effect at 3 and 6 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|369.0||||0.703|TWO_SIDED|95.0|-142.0|881.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|6-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||881|-142|0.703
71654046|NCT02409329|142825137|SUPERIORITY|We performed an omnibus test of the treatment effect at 3, 6, 12, and 15 months using a robust variance-covariance based Wald statistic. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|26.0||||0.465|TWO_SIDED|95.0|-459.0|511.0||A priori threshold p\<.05.|GEE, Wald test|Adjusted for baseline values with cubic splines (3 knots).|15-month point estimate|Any REACH vs. Helpline and A1c results. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||511|-459|0.465
71654047|NCT02409329|142825138|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.75|||||TWO_SIDED|95.0|-1.38|-0.12|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.12|-1.38|
71706256|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.5|6.7||||||Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-6.5|
71706257|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.7||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.||6.7|-3.6|
71706258|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-3.6|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-3.6|
71706259|NCT01026038|142930027|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.8|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.||6.6|-6.8|
71764545|NCT01024309|143031228|SUPERIORITY_OR_OTHER|||||||0.04||||||Apriori level of significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum was used||||||.04
71764546|NCT01024309|143031229|SUPERIORITY_OR_OTHER|||||||0.08||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test||||||0.08
71764547|NCT01024309|143031230|SUPERIORITY_OR_OTHER|||||||0.04||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.04
71764548|NCT01024309|143031231|SUPERIORITY_OR_OTHER|||||||0.22||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.22
71764549|NCT01024309|143031232|SUPERIORITY_OR_OTHER|||||||0.0029||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||.0029
71826085|NCT04771273|143156701|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|3.37||||0.0028|TWO_SIDED|95.0|1.52|7.45||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included actual treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||7.45|1.52|0.0028
71826086|NCT04771273|143156702|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.02||||0.0663|TWO_SIDED|95.0|0.95|4.27||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 2.4 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.27|0.95|0.0663
71826087|NCT04771273|143156702|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.01||||0.0672|TWO_SIDED|95.0|0.95|4.23||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 4.8 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.23|0.95|0.0672
71826088|NCT04771273|143156702|OTHER|No confirmatory hypothesis testing was performed.|Odds Ratio (OR)|2.11||||0.0512|TWO_SIDED|95.0|1.0|4.46||The p-value reported is considered nominal.|Regression, Logistic||Survodutide 6.0 mg vs. Placebo|The logistic regression model included planned treatment, presence of diabetes of any type and baseline fibrosis score. Firth's penalized regression was used.||4.46|1.00|0.0512
71764550|NCT01024309|143031233|SUPERIORITY_OR_OTHER|||||||0.13||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.13
71764551|NCT01024309|143031234|SUPERIORITY_OR_OTHER|||||||0.29||||||a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum||||||0.29
71764552|NCT01024309|143031235|SUPERIORITY_OR_OTHER|||||||0.23||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used||||||0.23
71764553|NCT01024309|143031236|SUPERIORITY_OR_OTHER|||||||0.49||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcox Rank Sum Test||||||0.49
71826089|NCT02162446|143156769|OTHER|||||||0.016|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.016
71764554|NCT02737891|143031246|SUPERIORITY||Mean Difference (Net)|-3.8||||0.004|TWO_SIDED|95.0|-6.36|-1.29||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-1.29|-6.36|0.004
71764555|NCT02737891|143031247|SUPERIORITY||Mean Difference (Net)|0.1||||0.724|TWO_SIDED|95.0|-0.23|0.33||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||0.33|-0.23|0.724
71826090|NCT02162446|143156769|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
71826091|NCT02162446|143156769|OTHER|||||||0.012|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.012
71826092|NCT02162446|143156769|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
71826093|NCT02162446|143156769|OTHER|||||||0.5|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.500
71826094|NCT02162446|143156769|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
71826095|NCT02162446|143156771|OTHER|||||||0.25|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.250
71826096|NCT02162446|143156771|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
71826097|NCT02162446|143156771|OTHER|||||||0.688|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.688
71826098|NCT02162446|143156771|OTHER|||||||0.578|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.578
71826099|NCT02162446|143156772|OTHER|||||||0.027|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.027
71826100|NCT02162446|143156772|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
71826101|NCT02162446|143156773|OTHER|||||||0.064|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.064
71706260|NCT01049828|142930052|OTHER|The analysis is based on a threshold-free cluster enhancement permutation technique.|||||<|0.01||||||all correlations were transformed into z scores using Fisher's transformation and a t test evaluated group differences.|Fisher Exact|The analysis is based on a threshold-free cluster enhancement permutation technique.||Null hypothesis: Fisher's transform z scores for a seed region were comparable between the control and non-bothered tinnitus groups.||||<0.01
71706261|NCT03572218|142930077|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
71706262|NCT03572218|142930078|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
71706263|NCT03572218|142930079|SUPERIORITY||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.9||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.03
71706264|NCT03572218|142930079|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.02|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.02
71706265|NCT03572218|142930079|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.19
71706266|NCT03572218|142930080|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|2.1||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.11
71706267|NCT03572218|142930080|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.03
71706268|NCT03572218|142930080|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.3||0.53|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.53
71706269|NCT03572218|142930081|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71706270|NCT03572218|142930082|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
71706271|NCT03572218|142930083|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.84|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.84
71706272|NCT03572218|142930083|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|4.0||0.82|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.82
71706273|NCT03572218|142930083|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.39|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.39
71706274|NCT03572218|142930083|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|5.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.42
71706275|NCT03572218|142930083|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|4.3||0.64|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.64
71706276|NCT03572218|142930083|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.6||0.59|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.59
71706277|NCT03572218|142930084|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|3.0||0.58|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score||||0.58
71706278|NCT03572218|142930084|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.0||0.89|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.89
71706279|NCT03572218|142930084|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.7||0.9|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.90
71706280|NCT03572218|142930084|SUPERIORITY||Mean Difference (Net)|-7.1|STANDARD_ERROR_OF_MEAN|5.0||0.16|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.16
71706281|NCT03572218|142930084|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|4.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.68
71706282|NCT03572218|142930084|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|3.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Lite||||0.72
71706283|NCT03572218|142930085|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||0.08
71706284|NCT03572218|142930086|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|1.7||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
71706285|NCT03572218|142930087|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
71706286|NCT03572218|142930088|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|1.1||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
71706287|NCT03572218|142930089|SUPERIORITY||Mean Difference (Net)|9.7|STANDARD_ERROR_OF_MEAN|6.5||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
71706288|NCT03572218|142930090|SUPERIORITY||Mean Difference (Net)|12.1|STANDARD_ERROR_OF_MEAN|6.5||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||0.06
71706289|NCT03572218|142930091|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|4.4||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71706290|NCT03572218|142930092|SUPERIORITY||Mean Difference (Net)|3.1|STANDARD_ERROR_OF_MEAN|4.4||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
71706291|NCT03572218|142930093|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.4||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
71706292|NCT03572218|142930094|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED||||||Mixed Models Analysis|||||||0.54
71706293|NCT03572218|142930095|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.2||0.94|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.94
71706294|NCT03572218|142930095|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.6||0.64|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.64
71826102|NCT02162446|143156773|OTHER|||||||0.339|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.339
71654048|NCT02409329|142825138|SUPERIORITY|Testing superiority of REACH only relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-1.0|0.39|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.39|-1.00|
71706295|NCT03572218|142930096|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.58|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.58
71706296|NCT03572218|142930096|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.49|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.49
71706297|NCT03572218|142930096|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.96|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.96
71706298|NCT03572218|142930096|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.71|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.71
71706299|NCT03572218|142930096|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.41|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.41
71706300|NCT03572218|142930097|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.61|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.61
71706301|NCT03572218|142930097|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.73
71706302|NCT03572218|142930097|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.94
71706303|NCT03572218|142930097|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.47|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.47
71706304|NCT03572218|142930097|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.99
71706305|NCT03572218|142930098|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71706306|NCT03572218|142930099|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71706307|NCT03572218|142930100|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71706308|NCT03572218|142930101|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71706309|NCT03572218|142930102|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.83
71706310|NCT03572218|142930102|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
71706311|NCT03572218|142930102|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.30
71706312|NCT03572218|142930102|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.99|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.99
71706313|NCT03572218|142930102|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.36|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.36
71706314|NCT03572218|142930103|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.30
71706315|NCT03572218|142930103|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.69|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.69
71706316|NCT03572218|142930103|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.70
71706317|NCT03572218|142930103|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.26|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.26
71706318|NCT03572218|142930103|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.18
71706319|NCT03572218|142930104|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.69
71706320|NCT03572218|142930104|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.28|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.28
71706321|NCT03572218|142930104|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.02
71706322|NCT03572218|142930105|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.29|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.29
71706323|NCT03572218|142930105|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.34|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.34
71706324|NCT03572218|142930105|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|0.8||0.001|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.001
71706325|NCT03572218|142930106|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.1||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
71706326|NCT03572218|142930107|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.2||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
71706327|NCT03572218|142930108|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|4.8||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71706328|NCT03572218|142930109|SUPERIORITY||Mean Difference (Net)|-10.2|STANDARD_ERROR_OF_MEAN|13.1||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
71706329|NCT03572218|142930110|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.46|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.46
71706330|NCT03572218|142930110|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.4||0.12|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.12
71826103|NCT02162446|143156773|OTHER|||||||0.001|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.001
71706331|NCT03572218|142930110|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.42|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.42
71706332|NCT03572218|142930110|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.03
71764556|NCT02737891|143031248|SUPERIORITY||Mean Difference (Net)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.65|-2.3||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.||-2.30|-4.65|<0.0001
71764557|NCT05194579|143031249|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% confidence intervals (CIs) for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays Cmax statistical analysis.|Ratio of Geometric Mean|117.06|||||TWO_SIDED|90.0|103.07|132.93|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||132.93|103.07|
71706333|NCT03572218|142930111|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
71706334|NCT03572218|142930111|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.9|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.90
71706335|NCT03572218|142930111|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.36|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.36
71706336|NCT03572218|142930111|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.29|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.29
71706337|NCT03572218|142930112|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
71706338|NCT03572218|142930113|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|2.2||0.27|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.27
71706339|NCT03572218|142930113|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.13
71706340|NCT03572218|142930113|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.4||0.65|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FNE||||0.65
71764558|NCT05194579|143031250|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUClast statistical analysis.|Ratio of Geometric Mean|122.12|||||TWO_SIDED|90.0|107.9|138.22|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||138.22|107.90|
71826104|NCT02162446|143156773|OTHER|||||||0|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.000
71706341|NCT03572218|142930114|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
71706342|NCT03572218|142930115|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7|TWO_SIDED||||||Mixed Models Analysis|||||||0.7
71706343|NCT03572218|142930116|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|1.8||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.2
71706344|NCT03572218|142930117|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|6.9||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71706345|NCT03572218|142930118|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|3.5||0.81|TWO_SIDED||||||Mixed Models Analysis|||Total||||0.81
71706346|NCT03572218|142930118|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|4.4||0.86|TWO_SIDED||||||Mixed Models Analysis|||Physical Function||||0.86
71706347|NCT03572218|142930118|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|7.0||0.87|TWO_SIDED||||||Mixed Models Analysis|||Self Esteem||||0.87
71706348|NCT03572218|142930118|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|5.2||0.73|TWO_SIDED||||||Mixed Models Analysis|||Sexual Life||||0.73
71706349|NCT03572218|142930118|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|4.4||0.95|TWO_SIDED||||||Mixed Models Analysis|||Work||||0.95
71706350|NCT03572218|142930118|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.8||0.19|TWO_SIDED||||||Mixed Models Analysis|||Public Distress||||0.19
71706351|NCT03572218|142930119|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|4.9||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
71706352|NCT03572218|142930120|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71706353|NCT03572218|142930121|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.5||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
71706354|NCT03572218|142930122|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.71|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.71
71706355|NCT03572218|142930122|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.72|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.72
71706356|NCT03572218|142930123|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71706357|NCT03572218|142930124|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.52|TWO_SIDED||||||Mixed Models Analysis|||Full Scale||||0.52
71706358|NCT03572218|142930124|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.02|TWO_SIDED||||||Mixed Models Analysis|||Negative Affect||||0.02
71706359|NCT03572218|142930124|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.63|TWO_SIDED||||||Mixed Models Analysis|||Maladaptive Eating||||0.63
71706360|NCT03572218|142930124|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.74|TWO_SIDED||||||Mixed Models Analysis|||Exercise Avoidance||||0.74
71706361|NCT03572218|142930124|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.49|TWO_SIDED||||||Mixed Models Analysis|||Healthy Lifestyle||||0.49
71706362|NCT03572218|142930125|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
71706363|NCT03572218|142930126|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
71706364|NCT03572218|142930127|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.35|TWO_SIDED||||||Mixed Models Analysis|||Global||||0.35
71826105|NCT02162446|143156773|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
71706365|NCT03572218|142930127|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.46|TWO_SIDED||||||Mixed Models Analysis|||Eating Restraint||||0.46
71706366|NCT03572218|142930127|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.33|TWO_SIDED||||||Mixed Models Analysis|||Eating Concern||||0.33
71706367|NCT03572218|142930127|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.18|TWO_SIDED||||||Mixed Models Analysis|||Weight Concern||||0.18
71706368|NCT03572218|142930127|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.16|TWO_SIDED||||||Mixed Models Analysis|||Shape Concern||||0.16
71706369|NCT03572218|142930128|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.3||0.82|TWO_SIDED||||||Mixed Models Analysis|||Dietary Restraint||||0.82
71706370|NCT03572218|142930128|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.8||0.45|TWO_SIDED||||||Mixed Models Analysis|||Disinhibition||||0.45
71826106|NCT02162446|143156773|OTHER|||||||1|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||1.000
71826107|NCT02162446|143156774|OTHER|||||||0.47|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.470
71826108|NCT02162446|143156774|OTHER|||||||0.233|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.233
71706371|NCT03572218|142930128|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.007|TWO_SIDED||||||Mixed Models Analysis|||Hunger||||0.007
71706372|NCT03572218|142930129|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.23|TWO_SIDED||||||Mixed Models Analysis|||Self-Reported Weighing||||0.23
71706373|NCT03572218|142930129|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED||||||Mixed Models Analysis|||Track Food/Drink||||0.48
71706374|NCT03572218|142930129|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.89|TWO_SIDED||||||Mixed Models Analysis|||Track Calories||||0.89
71706375|NCT03572218|142930129|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3|TWO_SIDED||||||Mixed Models Analysis|||Track Activity||||0.30
71706376|NCT03572218|142930130|SUPERIORITY|||||||0.32|||||||ANOVA|||BWL component||||0.32
71706377|NCT03572218|142930131|SUPERIORITY|||||||0.14|||||||ANOVA|||||||0.14
71706378|NCT00286455|142930132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.76|-0.31||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.31|-0.76|<0.001
71738963|NCT03637517|142990712|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|0.901||||0.31|TWO_SIDED|90.0|0.759|1.069|||ANOVA|||||1.069|0.759|0.3100
71738964|NCT03637517|142990712|EQUIVALENCE|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|1.156||||0.1619|TWO_SIDED|90.0|0.974|1.371|||ANOVA|||||1.371|0.974|0.1619
71738965|NCT02714283|142990717|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.19|TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use.|ICS (numerator) compared to macrolide monotherapy (denominator)|Due to the small sample size in the macrolide monotherapy group, for this outcome, the results are considered exploratory/descriptive only.||1.14|0.51|0.19
71738966|NCT02714283|142990718|SUPERIORITY||Hazard Ratio (HR)|1.39|||<|0.0001|TWO_SIDED|95.0|1.23|1.57|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.57|1.23|<0.0001
71738967|NCT02714283|142990719|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.21|TWO_SIDED|95.0|0.67|1.09|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.09|0.67|0.21
71738968|NCT02714283|142990720|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.82|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||0.82|0.64|<0.0001
71738969|NCT02714283|142990721|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.32|0.80|0.87
71738970|NCT02714283|142990722|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.23|TWO_SIDED|95.0|0.76|1.07|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.07|0.76|0.23
71738971|NCT02714283|142990723|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.2|TWO_SIDED|95.0|0.96|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|0.96|0.20
71764559|NCT05194579|143031251|EQUIVALENCE|Pharmacokinetic equivalence were assessed by constructing the 90% CIs for the GMR (test/reference) for Cmax, AUClast and AUCinf. This table displays AUCinf statistical analysis.|Ratio of Geometric Mean|123.75|||||TWO_SIDED|90.0|108.75|140.82|||ANOVA|||The null hypothesis was PF-06881894 OBI was not equivalent to PF-06881894 PFS.||140.82|108.75|
71826109|NCT02162446|143156774|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
71826110|NCT02162446|143156775|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.004
71826111|NCT02162446|143156775|OTHER|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.004
71826112|NCT02162446|143156775|OTHER|||||||0.426|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.426
71826113|NCT02162446|143156775|OTHER|||||||0.098|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.098
71738972|NCT02714283|142990724|SUPERIORITY||Hazard Ratio (HR)|1.15|||<|0.0001|TWO_SIDED|95.0|1.08|1.21|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.21|1.08|<0.0001
71738973|NCT02714283|142990725|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.66|1.51|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.51|0.66|0.99
71738974|NCT02714283|142990726|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.0005|TWO_SIDED|95.0|1.07|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)|||1.25|1.07|0.0005
71738975|NCT00620113|142990727|SUPERIORITY_OR_OTHER||Difference in LS Means|5.4|||<|0.001|TWO_SIDED|95.0|4.16|6.64||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an analysis of covariance (ANCOVA) model with terms for treatment and study center. Treatment effect was assessed by Least-Squares means (LS mean) and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.64|4.16|<0.001
71738976|NCT00620113|142990727|SUPERIORITY_OR_OTHER||Difference in LS Means|5.12|||<|0.001|TWO_SIDED|95.0|3.9|6.35||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.35|3.90|<0.001
71738977|NCT00620113|142990727|SUPERIORITY_OR_OTHER||Difference in LS Means|3.54|||<|0.001|TWO_SIDED|95.0|2.33|4.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.75|2.33|<0.001
71738978|NCT00620113|142990728|SUPERIORITY_OR_OTHER||Difference in LS Means|3.06|||<|0.001|TWO_SIDED|95.0|2.14|3.98||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.98|2.14|<0.001
71738979|NCT00620113|142990728|SUPERIORITY_OR_OTHER||Difference in LS Means|2.2|||<|0.001|TWO_SIDED|95.0|1.29|3.12||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.12|1.29|<0.001
71738980|NCT00620113|142990728|SUPERIORITY_OR_OTHER||Difference in LS Means|1.67|||<|0.001|TWO_SIDED|95.0|0.77|2.57||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||2.57|0.77|<0.001
71654049|NCT02409329|142825138|SUPERIORITY|Testing superiority of REACH\_FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.65|||||TWO_SIDED|95.0|-1.26|-0.05|||||6-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||-0.05|-1.26|
71654050|NCT02409329|142825138|SUPERIORITY|Testing superiority of REACH+FAMS relative to control. We used ordinary least squares linear regression with Huber-White heteroscedasticity-consistent standard errors to obtain point estimates and 95% CIs for the intervention effect at each time.|Predicted mean difference|-0.31|||||TWO_SIDED|95.0|-0.96|0.51|||||12-month point estimate|To evaluate if REACH only and REACH+FAMS had similar effects on HbA1c relative to control, we subsetted to participants with baseline HbA1c greater than or equal to 8.5% to maximize our power for these analyses. We used generalized estimating equations (GEE) with a working-exchangeable correlation structure and identity link, adjusting for baseline and allowing a time-treatment interaction. Multiply imputed data (m=1,000) using chained equations.||0.51|-0.96|
71654051|NCT02149121|142825144|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|97.07|||||TWO_SIDED|90.0|88.08|106.99|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using analysis of covariance (ANCOVA) model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||106.99|88.08|
71654052|NCT02149121|142825144|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.18|||||TWO_SIDED|90.0|85.4|103.86|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||103.86|85.40|
71654053|NCT02149121|142825144|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|103.07|||||TWO_SIDED|90.0|93.32|113.85|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.85|93.32|
71654054|NCT02149121|142825145|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|95.81|||||TWO_SIDED|90.0|87.39|105.04|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||105.04|87.39|
71706379|NCT00286455|142930132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.35|||ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.35|-0.80|<0.001
71706380|NCT00286455|142930133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.14|-0.39|<0.001
71706381|NCT00286455|142930133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.46|-0.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.46|<0.001
71706382|NCT00286455|142930134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.23|-0.57|<0.001
71706383|NCT00286455|142930134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
71826114|NCT02162446|143156775|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.813
71826115|NCT02162446|143156775|OTHER|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.813
71826116|NCT02162446|143156775|OTHER|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.||||0.297
71654055|NCT02149121|142825145|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.89|||||TWO_SIDED|90.0|81.85|98.72|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||98.72|81.85|
71654056|NCT02149121|142825145|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.58|||||TWO_SIDED|90.0|97.03|117.08|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||117.08|97.03|
71654057|NCT02149121|142825146|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|94.92|||||TWO_SIDED|90.0|89.61|100.55|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||100.55|89.61|
71654058|NCT02149121|142825146|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|89.0|||||TWO_SIDED|90.0|84.01|94.28|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||94.28|84.01|
71654059|NCT02149121|142825146|EQUIVALENCE|The equivalence of PK was to be concluded if the 90% CI for the ratio of geometric means in AUC0-last, AUC0-inf, and Cmax was entirely contained within the PK equivalence bounds of 80% and 125% for the following comparisons: CT-P10 versus Rituxan, CT-P10 versus MabThera, and Rituxan versus MabThera.|Ratio of geometric least squares means|106.66|||||TWO_SIDED|90.0|100.56|113.13|||||Point estimates (geometric least squares means and ratios of geometric means) were calculated by back-transforming the least squares means.|Primary PK analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, prior anti TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.||113.13|100.56|
71654060|NCT02149121|142825147|EQUIVALENCE|Therapeutic equivalence was to be concluded if the 90% CI for the treatment difference in the change from baseline of DAS28 (CRP) at Week 24 was entirely within the equivalence margin of ±0.50.|Mean Difference (Final Values)|-0.01|||||TWO_SIDED|90.0|-0.22|0.2|||||Adjusted least squares means and standard error, estimate of treatment difference \[CT-P10 - (Rituxan + MabThera)\] and 2-sided 90% confidence interval calculated from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA model with treatment group as a fixed effect and gender, region, race, study part, interaction of treatment group with study part, prior anti TNF alpha blocker status at baseline (intolerance case versus inadequate response), and RF or anti-CCP status fitted as covariates.||0.20|-0.22|
71654061|NCT02149121|142825152|OTHER||Ratio of geometric least squares means|102.37|||||TWO_SIDED|95.0|92.46|113.33||||||Secondary PD analysis were analyzed using an ANCOVA model with results as the response, treatment group, as fixed effect and baseline values, gender, region, race, study part, interaction of treatment group with study part, prior anti-TNF alpha blocker status, and RF or anti-CCP status fitted as covariates.|Estimate of Geometric Least Square Mean and ratio of Geometric Least Square Means (CT-P10/reference products) were obtained from back transforming the least square means from the ANCOVA.|113.33|92.46|
71654062|NCT03166124|142825153|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.953|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.953|
71654063|NCT03166124|142825153|SUPERIORITY||Ratio of Geometric LSMeans|1.03|||||TWO_SIDED|95.0|0.974|1.09|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.09|0.974|
71826117|NCT02162446|143156775|OTHER|||||||0.469|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.469
71826118|NCT02162446|143156776|OTHER|||||||0.91|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.910
71826119|NCT02162446|143156776|OTHER|||||||0.039|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.039
71826120|NCT02162446|143156776|OTHER|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.375
71826121|NCT02162446|143156776|OTHER|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.||||0.219
71654064|NCT03166124|142825154|SUPERIORITY||Ratio of Geometric LSMeans|1.04|||||TWO_SIDED|95.0|0.96|1.12|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.12|0.96|
71654065|NCT03166124|142825154|SUPERIORITY||Ratio of Geometric LSMeans|1.02|||||TWO_SIDED|95.0|0.94|1.1|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.10|0.94|
71654066|NCT03291041|142825168|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|34.75||||0.0354|TWO_SIDED||||||ANCOVA|||||||0.0354
71654067|NCT03291041|142825169|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-0.63||||0.0168|TWO_SIDED||||||ANCOVA|||||||0.0168
71654068|NCT03291041|142825170|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|90.56||||0.0785|TWO_SIDED||||||ANCOVA|||||||0.0785
71654069|NCT03291041|142825171|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|78.45||||0.0225|TWO_SIDED||||||ANCOVA|||||||0.0225
71654070|NCT03291041|142825172|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|0.95||||0.0198|TWO_SIDED||||||ANCOVA|||||||0.0198
71654071|NCT03291041|142825173|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-26.55||||0.0347|TWO_SIDED||||||ANCOVA|||||||0.0347
71654072|NCT03291041|142825174|SUPERIORITY|LS mean and p-value are from ANCOVA with treatment and time-zone-shift as main effects and baseline value as a covariate.|Mean Difference (Net)|-56.44||||0.084|TWO_SIDED||||||ANCOVA|||||||0.0840
71654073|NCT03291041|142825175|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0765|TWO_SIDED||||||ANCOVA|||||||0.0765
71654074|NCT00118378|142825223|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||< 0.001
71654075|NCT00118378|142825224|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
71654076|NCT00118378|142825225|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|95.0|||||ANOVA|||Week 4 CD4 cell count||||.150
71654077|NCT00118378|142825226|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED|95.0|||||ANOVA|||||||.459
71654078|NCT00836719|142825238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.01||95.0|3.4|16.2|||Mixed Models Analysis|Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.|Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.|N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.||16.2|3.4|<0.01
71654079|NCT02678442|142825243|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71654080|NCT02678442|142825245|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71654081|NCT02678442|142825246|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71654082|NCT02678442|142825247|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
71654083|NCT01045993|142825258|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
71654084|NCT01045993|142825259|NON_INFERIORITY_OR_EQUIVALENCE|The statistical alternative hypothesis tested is that the survival curves of time to first perceptible relief confirmed by meaningful relief are not identical between two treatment groups, or equivalently, the hazard ratio between two treatment groups is not equal to 1.||||||0.046|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.||||||0.046
71654085|NCT01045993|142825260|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using analysis of variance (ANOVA) model with treatment term only in the model.||||||<0.001
71654086|NCT01045993|142825261|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using ANOVA model with treatment term only in the model.||||||0.002
71654087|NCT01045993|142825263|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
71826122|NCT02085356|143156782|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|||||||||||||
71826123|NCT02085356|143156783|OTHER||Odds Ratio (OR)|0.32|||||TWO_SIDED|||||||||||||
71826124|NCT02085356|143156784|OTHER|||||||0.605|||||||Mixed Models Analysis|||||||0.605
71826125|NCT02085356|143156785|OTHER|||||||0.902|||||||Chi-squared|||Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.||||0.902
71826126|NCT02085356|143156786|OTHER|||||||0.869|||||||Mixed Models Analysis|||||||0.869
71826127|NCT02085356|143156786|OTHER||Odds Ratio (OR)|0.32||||0.982|TWO_SIDED||||||Mixed Models Analysis|||||||0.982
71706384|NCT00286455|142930135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.63|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.63|<0.001
71706385|NCT00286455|142930135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.73|-0.35||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.35|-0.73|<0.001
71706386|NCT00286455|142930136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.68|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.68|<0.001
71706387|NCT00286455|142930136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.74|<0.001
71706388|NCT00286455|142930137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.67|<0.001
71706389|NCT00286455|142930137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.70|<0.001
71706390|NCT00286455|142930138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2||||0.002|TWO_SIDED|95.0|-21.5|-5.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-21.5|0.002
71706391|NCT00286455|142930138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.0|-10.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.4|-27.0|<0.001
71706392|NCT00286455|142930139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-26.7|-10.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.1|-26.7|<0.001
71706393|NCT00286455|142930139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|||<|0.001|TWO_SIDED|95.0|-29.7|-13.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.0|-29.7|<0.001
71706394|NCT00286455|142930140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.4|||<|0.001|TWO_SIDED|95.0|-27.1|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-27.1|<0.001
71706395|NCT00286455|142930140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-33.2|-15.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.7|-33.2|<0.001
71706396|NCT00286455|142930141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7||||0.001|TWO_SIDED|95.0|-26.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-26.8|0.001
71826128|NCT00739102|143156787|SUPERIORITY_OR_OTHER||Proportion - 12-month patency rate|0.665|STANDARD_ERROR_OF_MEAN|0.032||0.437|TWO_SIDED|95.0|0.6|0.725||The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.|Agresti-Coull method||The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method|The null hypothesis to be tested was Ho: P = 0.66 against Ha: P \> 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.||0.725|0.6|0.437
71826129|NCT00739102|143156789|SUPERIORITY_OR_OTHER||Death Rate (%)|2.1|||||TWO_SIDED|95.0|0.7|4.9||||||||4.9|0.7|
71826130|NCT00739102|143156790|SUPERIORITY_OR_OTHER||Index Limb Amputation Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
71826131|NCT00739102|143156791|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
71826132|NCT00739102|143156792|SUPERIORITY_OR_OTHER||Clinically Driven TVR Rate (%)|13.6|||||TWO_SIDED|95.0|9.5|18.6||||||||18.6|9.5|
71764560|NCT03890666|143031255|OTHER||Odds Ratio (OR)|1.33||||||||||||||The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.||||
71764561|NCT00567255|143031276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.56|||<|0.001||95.0|-5.19|-3.93|||ANCOVA|||||-3.93|-5.19|<0.001
71764562|NCT00567255|143031277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.16|||<|0.001|TWO_SIDED|95.0|-5.95|-4.38|||ANCOVA|||||-4.38|-5.95|<0.001
71764563|NCT00567255|143031278|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.61|||<|0.001||95.0|4.95|8.84|||Regression, Logistic|||||8.84|4.95|<0.001
71764564|NCT00567255|143031279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|4.05|7.47|||Regression, Logistic|||||7.47|4.05|<0.001
71764565|NCT00567255|143031280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.001|TWO_SIDED|95.0|3.6|7.98|||Regression, Logistic|||||7.98|3.60|<0.001
71764566|NCT00567255|143031281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.43|||<|0.001|TWO_SIDED|95.0|-4.33|-2.53|||ANCOVA|||||-2.53|-4.33|<0.001
71764567|NCT00567255|143031282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.59|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||ANCOVA|||||3.57|1.61|<0.001
71764568|NCT00567255|143031283|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.96||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
71826133|NCT00739102|143156793|SUPERIORITY_OR_OTHER||Stent Fracture Rate (%)|1.5|||||TWO_SIDED|95.0|0.3|4.4||||||||4.4|0.3|
71826134|NCT00739102|143156794|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|5.6||||||95.0||||||||||||
71826135|NCT00739102|143156795|SUPERIORITY_OR_OTHER||Primary safety endpoint rate (%)|100.0|||<|0.001|TWO_SIDED|95.0|98.2|100.0|||Agresti-Coull method|||The null hypothesis to be tested was Ho: P = 0.88 against Ha: P \> 0.88, where 0.88 was the Objective Performance Criteria (OPC).||100|98.2|<0.001
71826136|NCT00739102|143156796|SUPERIORITY_OR_OTHER||Index Limb Ischemia Rate (%)|8.4||||||95.0||||||||||||
71826137|NCT00739102|143156799|SUPERIORITY_OR_OTHER||Major adverse event rate (%)|14.4|||||TWO_SIDED|95.0|10.2|19.5||||||||19.5|10.2|
71826138|NCT00646451|143156817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162|||||||ANOVA|||"Outcome on study completers was assessed via ANOVA models using a 2 × 2 Latin-square crossover design including sequence, period, and treatment effects. A significant carryover effect was excluded. Analyses were performed using Stata IC version 10.0 for Windows.~Unfortunately the small sample size of our study limits the possibility of a meaningful post-hoc analysis targeted to these variables."|The Quest rates patient perception of health status as influenced by tremor across 5 domains, physical, psychosocial, communication, hobbies/leisure, and work/finance. HAM-A rates severity of anxiety symptomatology across 14 parameters. Scores of 14-17 correspond to mild anxiety, scores of 18-24 is moderate anxiety and 25-30 severe anxiety. HD-16 rates insomnia-related QoL across 5 domains: physical symptoms, energy \& motivation, concentration, interpersonal relations and psychological symptoms. These scales were scored per published guidelines.|||0.162
71886553|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.111|=|0.9421|TWO_SIDED|95.0|-0.21|0.23|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 4-- Emraclidine 10 mg versus Placebo||0.23|-0.21|=0.9421
71764569|NCT00567255|143031284|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.77|||<|0.001|TWO_SIDED|95.0|2.46|5.09|||ANCOVA|||||5.09|2.46|<0.001
71764570|NCT00567255|143031285|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.24||||0.091|TWO_SIDED||||||ANCOVA|||||||0.091
71764571|NCT00567255|143031286|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.64|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71764572|NCT00567255|143031287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.6|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-1.60|
71764573|NCT00567255|143031288|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.29|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71764574|NCT00567255|143031289|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.23|||||TWO_SIDED|95.0|-9.92|-4.54||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-4.54|-9.92|
71764575|NCT00567255|143031290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|||||TWO_SIDED|95.0|-7.29|-1.44||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.44|-7.29|
71764576|NCT00567255|143031291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.7|1.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.30|-0.70|
71764577|NCT00567255|143031292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87|||||TWO_SIDED|95.0|0.16|1.58||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.58|0.16|
71764578|NCT00567255|143031293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.49|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.49|
71764579|NCT00567255|143031294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.56|0.52||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.52|-0.56|
71764580|NCT00567255|143031295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-0.98|0.02||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.02|-0.98|
71886554|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.116|=|0.5431|TWO_SIDED|95.0|-0.3|0.16|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 5-- Emraclidine 30 mg versus Placebo||0.16|-0.30|=0.5431
71706397|NCT00286455|142930141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.3|||<|0.001|TWO_SIDED|95.0|-32.4|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-32.4|<0.001
71706398|NCT00286455|142930142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5||||0.002|TWO_SIDED|95.0|-26.8|-6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.2|-26.8|0.002
71706399|NCT00286455|142930142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||<|0.001|TWO_SIDED|95.0|-31.6|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-31.6|<0.001
71706400|NCT00286455|142930143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||<|0.001|TWO_SIDED|95.0|-30.9|-8.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-30.9|<0.001
71706401|NCT00286455|142930143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||<|0.001|TWO_SIDED|95.0|-34.6|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-34.6|<0.001
71706402|NCT00286455|142930144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-30.6|-8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-30.6|<0.001
71706403|NCT00286455|142930144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED|95.0|-35.7|-12.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.9|-35.7|<0.001
71706404|NCT00286455|142930145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||<|0.001|TWO_SIDED|95.0|-34.1|-9.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.0|-34.1|<0.001
71706405|NCT00286455|142930145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|||<|0.001|TWO_SIDED|95.0|-40.4|-15.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-15.1|-40.4|<0.001
71706406|NCT00286455|142930146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.569||||0.165|TWO_SIDED|95.0|0.257|1.262|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.262|0.257|0.165
71706407|NCT00286455|142930146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.008|TWO_SIDED|95.0|0.138|0.739|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.739|0.138|0.008
71706408|NCT00286455|142930147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.194||||0.001|TWO_SIDED|95.0|0.073|0.516|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.516|0.073|0.001
71764581|NCT03052426|143031296|SUPERIORITY|||||||0.9327||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.1394, DF 2 for aches||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for aches/pains at the three month time frame||||0.9327
71764582|NCT03052426|143031296|SUPERIORITY|||||||0.7523||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.5693, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the three month time frame||||0.7523
71764583|NCT03052426|143031296|SUPERIORITY|||||||0.9196||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.1676, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the three month time frame.||||0.9196
71886555|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117|=|0.816|TWO_SIDED|95.0|-0.2|0.26|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 5-- Emraclidine 10 mg versus Placebo||0.26|-0.20|=0.8160
71764584|NCT03052426|143031297|SUPERIORITY|||||||0.6316||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.9190, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSquare Analysis were completed||||0.6316
71706409|NCT00286455|142930147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.145|||<|0.001|TWO_SIDED|95.0|0.052|0.405|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.405|0.052|<0.001
71706410|NCT00286455|142930148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.056|TWO_SIDED|95.0|-15.3|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.2|-15.3|0.056
71706411|NCT00286455|142930148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3|||<|0.001|TWO_SIDED|95.0|-21.1|-5.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-21.1|<0.001
71706412|NCT00286455|142930149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.85|TWO_SIDED|95.0|-7.8|9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.4|-7.8|0.850
71706413|NCT00286455|142930149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.571|TWO_SIDED|95.0|-6.2|11.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||11.2|-6.2|0.571
71706414|NCT00286455|142930150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.917|TWO_SIDED|95.0|-7.8|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-7.8|0.917
71706415|NCT00286455|142930150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.133|TWO_SIDED|95.0|-13.2|1.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.7|-13.2|0.133
71706416|NCT00286455|142930151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.348|TWO_SIDED|95.0|-12.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-12.1|0.348
71764585|NCT03052426|143031297|SUPERIORITY|||||||0.2595||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 2.6983, DF||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the six month time frame.||||0.2595
71764586|NCT03052426|143031297|SUPERIORITY|||||||0.4495||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 1.5991, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the six month time frame||||0.4495
71764587|NCT03052426|143031298|SUPERIORITY||||||<|0.0001||||||Aches (F-test G-G Epsilon (1.26, 15.18) = 34.70, p \< 0.0001)|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||<0.0001
71706417|NCT00286455|142930151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.152|TWO_SIDED|95.0|-14.3|2.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.2|-14.3|0.152
71706418|NCT00286455|142930152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.12|TWO_SIDED|95.0|-11.7|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-11.7|0.120
71706419|NCT00286455|142930152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5||||0.104|TWO_SIDED|95.0|-12.1|1.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.1|-12.1|0.104
71764588|NCT03052426|143031298|SUPERIORITY||||||=|0.0006||||||Uncomfortable (F-test G-G Epsilon (1.43, 17.15) = 14.39, p = 0.0006), from time 1 to times 2 and 3|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.||||=0.0006
71764589|NCT03052426|143031298|SUPERIORITY||||||<|0.0001||||||Interference (F-test G-G Epsilon (1.55, 18.66) = 34.09, p \< 0.0001), from time 1 to times 2 and 3.|MANOVA|||We used repeated measures MANOVAs with pairwise comparisons to examine the decrease of the variables over time. Significant differences for within subjects by time were found||||<0.0001
71764590|NCT03083990|143031302|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9502|||>|0.05|TWO_SIDED|90.0|0.8921|1.012|||ANOVA|||||1.0120|0.8921|>0.05
71654088|NCT01045993|142825263|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.016
71654089|NCT01045993|142825263|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||<0.001
71654090|NCT01045993|142825263|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.002
71654091|NCT01045993|142825263|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||<0.001
71654092|NCT01045993|142825263|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||<0.001
71654093|NCT01045993|142825263|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.003
71654094|NCT01045993|142825263|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.001
71654095|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint||||0.012
71654096|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint||||0.002
71654097|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint||||0.033
71654098|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint||||0.096
71654099|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint||||0.002
71654100|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint||||0.005
71654101|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint||||0.008
71764591|NCT03083990|143031303|EQUIVALENCE|Geometric mean ratio and its 90%CI are obtained after anti-logarithmic transformation.If 90% CI for the geometric mean ratio of AUC 0-t and AUC 0-∞ (trial/control) ranges between 0.8-1.25, then it is considered that IBI305 and Bevacizumab are bioequivalent.|Odds Ratio (OR)|0.9483|||>|0.05|TWO_SIDED|90.0|0.8896|1.0108|||ANOVA|||||1.0108|0.8896|>0.05
71764592|NCT03083990|143031304|EQUIVALENCE||Odds Ratio (OR)|0.9749|||>|0.05|TWO_SIDED|90.0|0.9123|1.0418|||ANOVA|||||1.0418|0.9123|>0.05
71826139|NCT01362491|143156827|SUPERIORITY_OR_OTHER||Least-Square (LS) mean difference|6.11|||<|0.001|TWO_SIDED|95.0|4.49|7.73||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||7.73|4.49|<0.001
71654102|NCT01045993|142825264|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint||||0.004
71654103|NCT01045993|142825265|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.268
71654104|NCT01045993|142825265|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.419
71654105|NCT01045993|142825265|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.086
71654106|NCT01045993|142825266|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.067
71706420|NCT00286455|142930153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.247|TWO_SIDED|95.0|-10.9|2.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.8|-10.9|0.247
71706421|NCT00286455|142930153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.129|TWO_SIDED|95.0|-12.3|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-12.3|0.129
71706422|NCT00286455|142930154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.671|TWO_SIDED|95.0|-4.14|2.67||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.67|-4.14|0.671
71706423|NCT00286455|142930154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.218|TWO_SIDED|95.0|-5.57|1.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.27|-5.57|0.218
71706424|NCT00286455|142930155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.403|TWO_SIDED|95.0|-2.07|5.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.14|-2.07|0.403
71706425|NCT00286455|142930155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.487|TWO_SIDED|95.0|-2.35|4.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.93|-2.35|0.487
71706426|NCT00286455|142930156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.143|TWO_SIDED|95.0|-0.88|6.08||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.08|-0.88|0.143
71706427|NCT00286455|142930156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.974|TWO_SIDED|95.0|-3.46|3.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.57|-3.46|0.974
71706428|NCT00286455|142930157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.612|TWO_SIDED|95.0|-2.78|4.71||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.71|-2.78|0.612
71706429|NCT00286455|142930157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.587|TWO_SIDED|95.0|-4.82|2.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.74|-4.82|0.587
71706430|NCT00286455|142930158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.514|TWO_SIDED|95.0|-2.0|3.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.99|-2.00|0.514
71706431|NCT00286455|142930158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.899|TWO_SIDED|95.0|-2.83|3.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.22|-2.83|0.899
71706432|NCT00286455|142930159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.885|TWO_SIDED|95.0|-3.09|3.58||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.58|-3.09|0.885
71706433|NCT00286455|142930159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.958|TWO_SIDED|95.0|-3.28|3.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.46|-3.28|0.958
71706434|NCT00286455|142930160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.003|TWO_SIDED|95.0|-0.084|-0.018||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.018|-0.084|0.003
71826140|NCT01362491|143156828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.253|TWO_SIDED|95.0|0.88|1.65||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.||1.65|0.88|0.253
71764593|NCT04145219|143031314|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average daily TCRS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.4|0.5|<0.0001
71826141|NCT01362491|143156829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.38|||<|0.001|TWO_SIDED|95.0|2.69|7.14||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.14|2.69|<0.001
71706435|NCT00286455|142930160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.072|||<|0.001|TWO_SIDED|95.0|-0.105|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.105|<0.001
71706436|NCT00286455|142930161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|||<|0.001|TWO_SIDED|95.0|-0.099|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.038|-0.099|<0.001
71706437|NCT00286455|142930161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052||||0.001|TWO_SIDED|95.0|-0.083|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.083|0.001
71706438|NCT00286455|142930162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|||<|0.001|TWO_SIDED|95.0|-0.103|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.103|<0.001
71706439|NCT00286455|142930162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||<|0.001|TWO_SIDED|95.0|-0.109|-0.037||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.037|-0.109|<0.001
71654107|NCT01045993|142825266|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.757
71654108|NCT01045993|142825266|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.219
71654109|NCT01045993|142825267|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.043
71654110|NCT01045993|142825267|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.388
71654111|NCT01045993|142825267|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.039
71654112|NCT01045993|142825268|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.797
71706440|NCT00286455|142930163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||0.021|TWO_SIDED|95.0|-0.084|-0.007||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.007|-0.084|0.021
71654113|NCT01045993|142825269|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.371
71654114|NCT01045993|142825270|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||||||0.122
71826142|NCT01362491|143156829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.64|||<|0.001|TWO_SIDED|95.0|2.23|5.94||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||5.94|2.23|<0.001
71706441|NCT00286455|142930163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.043|TWO_SIDED|95.0|-0.079|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.079|0.043
71886556|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124|=|0.2534|TWO_SIDED|95.0|-0.39|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.10|-0.39|=0.2534
71826143|NCT01362491|143156830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.68|||<|0.001|TWO_SIDED|95.0|2.87|7.64||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||7.64|2.87|<0.001
71654115|NCT01045993|142825271|SUPERIORITY_OR_OTHER|||||||0.355||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.355
71654116|NCT01045993|142825271|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.371
71654117|NCT01045993|142825271|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-values from ANOVA model with treatment treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.216
71654118|NCT01045993|142825272|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.054
71654119|NCT01045993|142825272|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.600
71654120|NCT01045993|142825272|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.294
71654121|NCT01045993|142825273|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees||||0.088
71654122|NCT01045993|142825273|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees||||0.625
71654123|NCT01045993|142825273|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)||||0.034
71654124|NCT01045993|142825274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Cochran-Mantel-Haenszel|P-value from the Cochran-Mantel-Haenszel test with modified ridit scores.||||||<0.001
71654125|NCT01659736|142825276|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||p-value is for the condition (active TMS versus Sham) by time (pre, post, 3-month follow-up) interaction|ANOVA|||||||0.006
71654126|NCT00391079|142825281|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.17||||0.468|TWO_SIDED|95.0|-0.62|0.29|||ANCOVA|||The change in pain NRS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.29|-0.62|0.468
71654127|NCT00391079|142825282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.309||||0.2338|TWO_SIDED|95.0|0.84|2.038|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each Sativex and placebo.||2.038|0.840|0.2338
71654128|NCT00391079|142825283|SUPERIORITY_OR_OTHER||Estimated treatment effect|-1.83||||0.3103|TWO_SIDED|95.0|-5.39|1.72|||ANOVA||A negative difference in estimated treatment effect indicates an improvement in pain in favour of Sativex.|The change in NPS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||1.72|-5.39|0.3103
71654129|NCT00391079|142825284|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.24||||0.1567|TWO_SIDED|95.0|-0.57|0.09|||ANCOVA||A negative difference in estimated treatment difference indicates a reduction in breakthrough analgesic medication in favour of Sativex.|The change in average number of tablets taken daily from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.||0.09|-0.57|0.1567
71826144|NCT01362491|143156830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.88|||<|0.001|TWO_SIDED|95.0|2.38|6.34||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||6.34|2.38|<0.001
71826145|NCT01362491|143156830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.247|TWO_SIDED|95.0|0.88|1.66||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.66|0.88|0.247
71764594|NCT04145219|143031315|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.0001|TWO_SIDED|95.0|0.2|0.6||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.6|0.2|<0.0001
71764595|NCT04145219|143031316|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0016|TWO_SIDED|95.0|0.2|0.8||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis|||The average rhinitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.8|0.2|0.0016
71764596|NCT04145219|143031317|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.0001|TWO_SIDED|95.0|0.6|1.7||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs.12 SQ-HDM|||1.7|0.6|<0.0001
71764597|NCT04145219|143031318|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.7|0.3|<0.0001
71654130|NCT00391079|142825285|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.5643|TWO_SIDED|95.0|-0.53|0.29|||ANCOVA||A negative difference in estimated means indicates an improvement in pain in favour of Sativex.|||0.29|-0.53|0.5643
71764598|NCT04145219|143031319|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0018|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis DMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|0.2|0.0018
71764599|NCT04145219|143031320|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.2||This endpoint was controlled for multiplicity using hierarchical testing|Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The overall PRQLQ score was analysed using a linear mixed effect (LME) model. The model includes the overall PRQLQ score as response variable, treatment and cohort as fixed factors, the baseline overall PRQLQ score as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.1|<0.0001
71764600|NCT04145219|143031321|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.0259|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average asthma DSS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.2|0.0|0.0259
71764601|NCT04145219|143031322|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0527|TWO_SIDED|95.0|1.0|3.3|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a SABA free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included SABA free day (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average asthma DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day where a subject with asthma did not use SABA, odds ratio is (odds active/odds Placebo).||3.3|1.0|0.0527
71764602|NCT04145219|143031323|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1256|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The endpoint was analysed using a linear mixed effect (LME) model. The model includes the endpoint as response variable, treatment and cohort as fixed factors, the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||1.0|-0.1|0.1256
71654131|NCT00391079|142825286|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.47||||0.0552|TWO_SIDED|95.0|0.991|2.179|||Regression, Logistic||An odds ratio of greater than 1 indicates and improvement in favour of Sativex.|||2.179|0.991|0.0552
71706442|NCT00286455|142930164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|||<|0.001|TWO_SIDED|95.0|-0.255|-0.069||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.069|-0.255|<0.001
71886557|NCT05227690|143293400|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.125|=|0.6774|TWO_SIDED|95.0|-0.3|0.19|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.19|-0.30|=0.6774
71826146|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.92|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.92|<0.001
71826147|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.93|1.61||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.61|0.93|< 0.001
71826148|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.29|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.29|0.943
71826149|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.89|1.62||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.62|0.89|<0.001
71826150|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.85|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.85|<0.001
71826151|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.847|TWO_SIDED|95.0|-0.27|0.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.33|-0.27|0.847
71706443|NCT00286455|142930164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.001|TWO_SIDED|95.0|-0.254|-0.065||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.065|-0.254|0.001
71764603|NCT04145219|143031324|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0008|TWO_SIDED|95.0|1.3|2.5|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis mild day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis TCRS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a day with no or mild rhinitis symptoms, odds ratio is (odds 12 SQ-HDM / odds Placebo).||2.5|1.3|0.0008
71826152|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.59|||<|0.001|TWO_SIDED|95.0|1.14|2.05||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.05|1.14|<0.001
71826153|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.68|||<|0.001|TWO_SIDED|95.0|1.22|2.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.13|1.22|<0.001
71886558|NCT05227690|143293401|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.9|||=|0.0904|TWO_SIDED|95.0|0.9|3.99|||Regression, Logistic|||Emraclidine 30 mg versus Placebo||3.99|0.90|=0.0904
71706444|NCT00286455|142930165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.086||||0.001|TWO_SIDED|95.0|-0.138|-0.034||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.034|-0.138|0.001
71826154|NCT01362491|143156831|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.08||||0.663|TWO_SIDED|95.0|-0.46|0.29||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - (Ibuprofen IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.29|-0.46|0.663
71764604|NCT04145219|143031325|SUPERIORITY||Odds Ratio (OR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Generalised linear mixed model (GLMM)||Odds ratio is (odds 12 SQ-HDM / odds Placebo)|The odds of having a rhinitis exacerbation day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included the endpoint (yes/no) as response variable, treatment and cohort as fixed effects, the baseline average rhinitis DSS as a covariate, the combined (country/region) variable within cohort and subject as random effects. Proportion is the estimated probability of having a rhinitis exacerbation day, odds ratio is (odds 12 SQ-HDM / odds Placebo).||0.7|0.4|<0.0001
71764605|NCT04145219|143031326|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
71764606|NCT04145219|143031327|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.3|||Mixed Models Analysis||Placebo vs. 12 SQ-HDM|The average rhinoconjunctivitis CSMS was analysed using a linear mixed effect (LME) model with square root transformation. The model includes the square root of the endpoint as response variable, treatment and cohort as fixed factors, the square root of the baseline value as a covariate, country/region within cohort as a random effect, and with different residual errors specified for each treatment. No missing data approach was applied.||0.3|0.1|<0.0001
71764607|NCT04556383|143031406|SUPERIORITY||Risk Difference (RD)|-2.6||||0.6694|TWO_SIDED|95.0|-15.2|10.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||10.2|-15.2|0.6694
71764608|NCT04556383|143031406|SUPERIORITY||Risk Difference (RD)|4.6||||0.4719|TWO_SIDED|95.0|-9.0|17.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.8|-9.0|0.4719
71764609|NCT04556383|143031408|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3263|TWO_SIDED|95.0|-23.2|8.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.3|-23.2|0.3263
71764610|NCT04556383|143031408|SUPERIORITY||Risk Difference (RD)|10.2||||0.2002|TWO_SIDED|95.0|-6.1|25.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||25.8|-6.1|0.2002
71764611|NCT04556383|143031409|SUPERIORITY||Risk Difference (RD)|0.4||||0.9472|TWO_SIDED|95.0|-15.2|15.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.9|-15.2|0.9472
71764612|NCT04556383|143031409|SUPERIORITY||Risk Difference (RD)|6.8||||0.3685|TWO_SIDED|95.0|-9.3|22.4|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.4|-9.3|0.3685
71764613|NCT04556383|143031410|SUPERIORITY||Risk Difference (RD)|1.3||||0.8484|TWO_SIDED|95.0|-12.7|15.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||15.2|-12.7|0.8484
71764614|NCT04556383|143031410|SUPERIORITY||Risk Difference (RD)|8.2||||0.2392|TWO_SIDED|95.0|-6.4|22.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||22.3|-6.4|0.2392
71764615|NCT04556383|143031411|SUPERIORITY||Risk Difference (RD)|-1.2||||0.8493|TWO_SIDED|95.0|-14.8|12.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||12.5|-14.8|0.8493
71764616|NCT04556383|143031411|SUPERIORITY||Risk Difference (RD)|2.6||||0.6647|TWO_SIDED|95.0|-11.5|16.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||16.5|-11.5|0.6647
71764617|NCT04556383|143031412|SUPERIORITY||Risk Difference (RD)|-6.5||||0.2263|TWO_SIDED|95.0|-19.1|6.0|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.0|-19.1|0.2263
71764618|NCT04556383|143031412|SUPERIORITY||Risk Difference (RD)|-1.4||||0.8259|TWO_SIDED|95.0|-14.8|12.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.2|-14.8|0.8259
71764619|NCT04556383|143031413|SUPERIORITY||Risk Difference (RD)|2.8||||0.7418|TWO_SIDED|95.0|-12.7|18.1|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||18.1|-12.7|0.7418
71764620|NCT04556383|143031413|SUPERIORITY||Risk Difference (RD)|8.4||||0.2758|TWO_SIDED|95.0|-7.8|24.2|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||24.2|-7.8|0.2758
71764621|NCT04556383|143031414|SUPERIORITY||Risk Difference (RD)|-6.0||||0.3504|TWO_SIDED|95.0|-20.6|8.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||8.9|-20.6|0.3504
71764622|NCT04556383|143031414|SUPERIORITY||Risk Difference (RD)|1.7||||0.8009|TWO_SIDED|95.0|-14.2|17.5|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||17.5|-14.2|0.8009
71764623|NCT04556383|143031415|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9474|TWO_SIDED|95.0|-14.3|13.7|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||13.7|-14.3|0.9474
71764624|NCT04556383|143031415|SUPERIORITY||Risk Difference (RD)|-3.0||||0.6409|TWO_SIDED|95.0|-16.6|10.8|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||10.8|-16.6|0.6409
71764625|NCT04556383|143031416|SUPERIORITY||Risk Difference (RD)|-8.0||||0.1932|TWO_SIDED|95.0|-22.4|6.3|||Cochran-Mantel-Haenszel||PCP GB004 480 mg QD vs Placebo.|||6.3|-22.4|0.1932
71764626|NCT04556383|143031416|SUPERIORITY||Risk Difference (RD)|-2.3||||0.7459|TWO_SIDED|95.0|-17.6|12.9|||Cochran-Mantel-Haenszel||PCP GB004 480 mg BID vs Placebo.|||12.9|-17.6|0.7459
71764627|NCT00119678|143031421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.7|1.5|||||Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.|||1.5|0.7|
71764628|NCT00796926|143031465|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
71764629|NCT00006289|143031481|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
71764630|NCT00006289|143031482|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
71826155|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.54|||<|0.001|TWO_SIDED|95.0|0.37|0.72||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.72|0.37|<0.001
71826156|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.51|||<|0.001|TWO_SIDED|95.0|0.33|0.69||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.33|<0.001
71654132|NCT00391079|142825287|SUPERIORITY_OR_OTHER||estimated treatment difference|0.05||||0.833|TWO_SIDED|95.0|-0.39|0.48|||ANCOVA||A negative difference in estimated treatment difference indicates an improvement in sleep quality in favour of Sativex.|||0.48|-0.39|0.8330
71654133|NCT00474851|142825296|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED|||||p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10|RMANOVA|||"Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.10
71654134|NCT00474851|142825297|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02|RMANOVA|||"The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."||||0.02
71654135|NCT02791893|142825298|SUPERIORITY|||||||0.47||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.47
71654136|NCT02791893|142825298|SUPERIORITY|||||||0.58||||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase are not included limiting the sample to 10 subjects in each condition (N=20). Post-intervention pain severity was regressed on pre-intervention pain severity and condition, using an ANCOVA model.||||0.58
71654137|NCT02791893|142825299|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.||"A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase were assigned a score of 1 indicating no change in their condition. Post-intervention PGIC scores were compared between conditions."||||0.23
71654138|NCT02791893|142825299|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.23|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was an independent t-test comparing the conditions on their perception of change since starting the intervention.|Condition difference = Active - Sham|Below are the results of the per protocol analysis. Post-intervention PGIC scores were compared between conditions.||||0.23
71654139|NCT02791893|142825300|SUPERIORITY||Mean Difference (Final Values)|12.88||||0.13|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.13
71654140|NCT02791893|142825300|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.12|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA|||Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention physical function scores was regressed on pre-intervention physical function and condition, using an ANCOVA model.||||0.12
71706445|NCT00286455|142930165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084||||0.002|TWO_SIDED|95.0|-0.137|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.032|-0.137|0.002
71706446|NCT00286455|142930166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.23|TWO_SIDED|95.0|-0.568|0.137||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.137|-0.568|0.230
71764631|NCT00006289|143031483|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).||||0.0058
71764632|NCT02043808|143031486|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.92|0.52|
71764633|NCT02043808|143031487|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.98|0.71|
71764634|NCT02043808|143031488|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.79|||||TWO_SIDED|95.0|0.59|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.59|
71764635|NCT02043808|143031489|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.31|||||TWO_SIDED|95.0|0.13|0.7|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.70|0.13|
71764636|NCT02043808|143031490|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.48|||||TWO_SIDED|95.0|0.3|0.77|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.77|0.30|
71764637|NCT02043808|143031491|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.07|0.76|
71764638|NCT02043808|143031492|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.07|||||TWO_SIDED|95.0|0.89|1.3|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.30|0.89|
71764639|NCT02043808|143031493|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.72|||||TWO_SIDED|95.0|0.5|1.03|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.03|0.50|
71764640|NCT02043808|143031494|SUPERIORITY_OR_OTHER||Crude event rate ratio|1.24|||||TWO_SIDED|95.0|0.99|1.54|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.54|0.99|
71764641|NCT02043808|143031495|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.35|||||TWO_SIDED|95.0|0.17|0.72|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.72|0.17|
71764642|NCT02043808|143031496|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.37|||||TWO_SIDED|95.0|0.22|0.64|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.64|0.22|
71826157|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.03||||0.651|TWO_SIDED|95.0|-0.11|0.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.18|-0.11|0.651
71764643|NCT02043808|143031497|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.83|||||TWO_SIDED|95.0|0.55|1.26|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.26|0.55|
71764644|NCT02043808|143031498|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.66|||||TWO_SIDED|95.0|0.45|0.95|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.95|0.45|
71764645|NCT02043808|143031499|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.31|0.31|
71764646|NCT02043808|143031500|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.44|||||TWO_SIDED|95.0|0.16|1.21|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||1.21|0.16|
71764647|NCT02043808|143031501|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.97|||||TWO_SIDED|95.0|0.34|2.81|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||2.81|0.34|
71764648|NCT02043808|143031502|SUPERIORITY_OR_OTHER||Crude event rate ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||Crude event rate ratio for dabigatran with warfarin as the reference group|||0.69|0.52|
71764649|NCT01888432|143031513|NON_INFERIORITY|HO: πT - πC ≥ 0.12 vs. HA: πT - πC \< 0.12, where πT and πC are the true proportions of composite efficacy failure of tBPAR, GL, or D, (tBPAR/GL/D) at 12 months post-transplant for the respective treatment groups. The proportion of 0.12, or 12%, was pre-determined as the non-inferiority (NI) margin for composite efficacy failure.|Kaplan-Meier|-0.7|||<|0.001|TWO_SIDED|90.0|-5.2|3.7||Z-test p-value for non-inferiority test (non-inferiority margin = 12%) is for one-sided test and should be compared to 0.05 significance level.|Z-test|||non-inferior efficacy failure of the reduced tacrolimus regimen to control by rejecting the null hypothesis.||3.7|-5.2|< 0.001
71764650|NCT01888432|143031514|NON_INFERIORITY|the null hypothesis below was tested at the one-sided α = 0.05 level: H0: μT - μC ≤ -6 mL/min/1.73 m2 vs. HA: μT - μC \> -6 mL/min/1.73 m\^2, where μT and μC are the true means of change in eGFR (MDRD-4) from randomization to Month 12 post-transplant for the reduced tacrolimus group and control group, respectively.|Mean Difference (Net)|4.15|STANDARD_ERROR_OF_MEAN|2.574|<|0.001|TWO_SIDED|90.0|-0.09|8.4|||ANCOVA|||||8.40|-0.09|< 0.001
71764651|NCT01888432|143031515|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.699|<|0.001|TWO_SIDED|90.0|-1.21|7.7|||ANCOVA|||||7.70|-1.21|<0.001
71764652|NCT01888432|143031517|OTHER|Month 12|Kaplan-Meier|-1.4|||||TWO_SIDED|90.0|-4.7|2.0|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.0|-4.7|
71764653|NCT01888432|143031517|OTHER|tBPAR - month 24|Kaplan-Meier|-1.2|||||TWO_SIDED|90.0|-5.1|2.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||2.6|-5.1|
71764654|NCT01888432|143031517|OTHER|On-treatment tBPAR - month 24|Kaplan-Meier|-2.1|||||TWO_SIDED|90.0|-5.7|1.4|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||1.4|-5.7|
71826158|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.62|||<|0.001|TWO_SIDED|95.0|0.42|0.81||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.81|0.42|<0.001
71764655|NCT01888432|143031518|OTHER|Month 12|Kaplan-Meier|0.9|||||TWO_SIDED|90.0|-3.4|5.1|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.1|-3.4|
71764656|NCT01888432|143031518|OTHER|Month 24|Kaplan-Meier|1.0|||||TWO_SIDED|90.0|-3.6|5.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||5.6|-3.6|
71764657|NCT01888432|143031519|OTHER|graft loss at month 24|Kaplan-Meier|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||0.5|-2.1|
71764658|NCT01888432|143031520|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
71764659|NCT01888432|143031520|OTHER|Month 24|Kaplan-Meier|2.3|||||TWO_SIDED|90.0|-2.1|6.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||6.6|-2.1|
71764660|NCT01888432|143031521|OTHER|Month 12|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.8|-2.5|
71764661|NCT01888432|143031521|OTHER|Month 24|Kaplan-Meier|3.0|||||TWO_SIDED|90.0|-1.1|7.2|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||7.2|-1.1|
71826159|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.65|||<|0.001|TWO_SIDED|95.0|0.46|0.85||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|0.46|<0.001
71826160|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.03||||0.669|TWO_SIDED|95.0|-0.19|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.19|0.669
71826161|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.57|<0.001
71826162|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.67|1.21||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.21|0.67|<0.001
71826163|NCT01362491|143156832|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.396|TWO_SIDED|95.0|-0.32|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.32|0.396
71886559|NCT05227690|143293401|SUPERIORITY|Odds ratio, 95% confidence interval, and p-value were from a logistic regression with treatment group, geographic region and Baseline value as a covariate.|Odds Ratio|1.96|||=|0.0756|TWO_SIDED|95.0|0.93|4.13|||Regression, Logistic|||Emraclidine 10 mg versus Placebo||4.13|0.93|=0.0756
71764662|NCT01888432|143031521|OTHER|Month 24 (On-treatment death)|Kaplan-Meier|0.7|||||TWO_SIDED|90.0|-2.5|3.9|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood's formula.|||3.9|-2.5|
71764663|NCT01888432|143031522|OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|90.0|-3.9|5.3|||||Month 12|||5.3|-3.9|
71764664|NCT01888432|143031522|OTHER||Risk Difference (RD)|2.1|||||TWO_SIDED|90.0|-3.0|7.2|||||Month 24|||7.2|-3.0|
71764665|NCT01888432|143031523|OTHER||Risk Ratio (RR)|-0.7|||||TWO_SIDED|90.0|-4.5|3.1|||||Month 12|||3.1|-4.5|
71764666|NCT01888432|143031523|OTHER||Risk Ratio (RR)|0.0|||||TWO_SIDED|90.0|-4.2|4.2|||||Month 24|||4.2|-4.2|
71764667|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|5.4|||||TWO_SIDED|95.0|-19.9|30.6|||||Composite endpoint|||30.6|-19.9|
71764668|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|6.7|||||TWO_SIDED|95.0|-6.0|19.3|||||On-treatment composite endpoint|||19.3|-6.0|
71764669|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|2.0|||||TWO_SIDED|95.0|-24.6|28.7|||||Graft loss/death|||28.7|-24.6|
71764670|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tBPAR|||33.1|-4.2|
71764671|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|11.1|||||TWO_SIDED|95.0|-9.4|31.6|||||Death|||31.6|-9.4|
71764672|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||AR|||35.2|-28.9|
71764673|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|14.4|||||TWO_SIDED|95.0|-4.2|33.1|||||tAR|||33.1|-4.2|
71764674|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|14.9|||||TWO_SIDED|95.0|-22.3|52.1|||||BPR|||52.1|-22.3|
71764675|NCT01888432|143031527|OTHER||Difference in Kaplan-Meier estimate|3.2|||||TWO_SIDED|95.0|-28.9|35.2|||||BPAR|||35.2|-28.9|
71764676|NCT01888432|143031528|OTHER||Mean Difference (Final Values)|-10.01|STANDARD_ERROR_OF_MEAN|22.059|||TWO_SIDED|95.0|-59.91|39.89||||||||39.89|-59.91|
71764677|NCT03054129|143031529|SUPERIORITY|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
71886560|NCT05227690|143293408|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.2418|TWO_SIDED|95.0|0.0|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|0.0|=0.2418
71826164|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.8|||<|0.001|TWO_SIDED|95.0|1.3|2.3||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.30|1.30|<0.001
71764678|NCT03054129|143031530|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
71764679|NCT03054129|143031531|SUPERIORITY|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||||||0.565
71826165|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.78|||<|0.001|TWO_SIDED|95.0|1.28|2.28||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.28|1.28|<0.001
71826166|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.911|TWO_SIDED|95.0|-0.39|0.43||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.43|-0.39|0.911
71826167|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.33|2.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.41|1.33|<0.001
71826168|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.34|2.42||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.42|1.34|<0.001
71706447|NCT00286455|142930166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.154||||0.393|TWO_SIDED|95.0|-0.508|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.200|-0.508|0.393
71706448|NCT00286455|142930167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084||||0.703|TWO_SIDED|95.0|-0.348|0.515||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.515|-0.348|0.703
71706449|NCT00286455|142930167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.203|TWO_SIDED|95.0|-0.153|0.717||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.717|-0.153|0.203
71706450|NCT00286455|142930168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169||||0.408|TWO_SIDED|95.0|-0.232|0.569||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.569|-0.232|0.408
71706451|NCT00286455|142930168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.949|TWO_SIDED|95.0|-0.391|0.417||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.417|-0.391|0.949
71706452|NCT00286455|142930169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.886|TWO_SIDED|95.0|-0.44|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.440|0.886
71706453|NCT00286455|142930169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.645|TWO_SIDED|95.0|-0.51|0.317||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.317|-0.510|0.645
71706454|NCT00286455|142930170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.656|TWO_SIDED|95.0|-0.378|0.239||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.239|-0.378|0.656
71706455|NCT00286455|142930170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.819|TWO_SIDED|95.0|-0.347|0.275||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.275|-0.347|0.819
71826169|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.982|TWO_SIDED|95.0|-0.45|0.44||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.45|0.982
71826170|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.72|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.72|<0.001
71654141|NCT02791893|142825301|SUPERIORITY||Mean Difference (Final Values)|-5.71||||0.58|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.58
71654142|NCT02791893|142825301|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.49|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention headache days was regressed on pre-intervention headache days and condition, using an ANCOVA model.||||0.49
71654143|NCT02791893|142825302|SUPERIORITY||Mean Difference (Final Values)|-1.42||||0.18|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|A power analysis was conducted with G\*Power, specifying a standard Type I error (α = .05) and desired power of .80. Results indicated that a total sample of 26 would be sufficient. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.18
71654144|NCT02791893|142825302|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was p = 0.05.|ANCOVA||Condition difference = Active - Sham|Below are the results of the per protocol analysis. Patients that did not complete the assessment after the blinded phase had their baseline scores carried forward. Post-intervention depression scores were regressed on pre-intervention depression scores and condition, using an ANCOVA model.||||0.25
71654145|NCT02791893|142825303|SUPERIORITY|||||||0.004||||||The a priori threshold for statistical significance was p = 0.05.|t-test, 2 sided|This was a dependent t-test comparing pre-intervention scores to the scores collected at the end of the open label phase.||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the intent-to-treat analysis. Patients that did not complete the assessment after the open-label phase had their most recent score carried forward. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.004
71654146|NCT02791893|142825303|SUPERIORITY|||||||0.005||||||This was a dependent t-test comparing baseline scores to the scores collected at the end of the open label phase.|t-test, 2 sided|||Regardless of original condition assignment, patients' 2.5-month pain scores at the end of the open label phase were compared to their baseline scores using a dependent samples t-test. Below are the results of the per protocol analysis. Patients that did not complete the assessment after the open-label phase were excluded. All patients included in this comparison received at least 10 weeks of VNS therapy.||||0.005
71654147|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
71706456|NCT00286455|142930171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079||||0.642|TWO_SIDED|95.0|-0.411|0.253||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.253|-0.411|0.642
71706457|NCT00286455|142930171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.986|TWO_SIDED|95.0|-0.332|0.338||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.338|-0.332|0.986
71706458|NCT00286455|142930172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686||||0.305|TWO_SIDED|95.0|0.622|4.571|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.571|0.622|0.305
71706459|NCT00286455|142930172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.349||||0.091|TWO_SIDED|95.0|0.873|6.321|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.321|0.873|0.091
71706460|NCT00286455|142930173|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.704||||0.001|TWO_SIDED|95.0|1.694|8.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.100|1.694|0.001
71706461|NCT00286455|142930173|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.305||||0.003|TWO_SIDED|95.0|1.505|7.255|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.255|1.505|0.003
71706462|NCT00286455|142930174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.905||||0.006|TWO_SIDED|95.0|1.359|6.21|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.210|1.359|0.006
71706463|NCT00286455|142930174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.552|||<|0.001|TWO_SIDED|95.0|2.068|10.017|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.017|2.068|<0.001
71706464|NCT00286455|142930175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.663||||0.004|TWO_SIDED|95.0|1.367|5.188|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.188|1.367|0.004
71706465|NCT00286455|142930175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.277|||<|0.001|TWO_SIDED|95.0|1.671|6.429|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.429|1.671|<0.001
71706466|NCT00286455|142930176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.331||||0.002|TWO_SIDED|95.0|1.714|10.947|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||10.947|1.714|0.002
71706467|NCT00286455|142930176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.732||||0.001|TWO_SIDED|95.0|1.862|12.025|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||12.025|1.862|0.001
71706468|NCT00286455|142930177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.766||||0.153|TWO_SIDED|95.0|0.685|11.16|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.160|0.685|0.153
71706469|NCT00286455|142930177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.632||||0.029|TWO_SIDED|95.0|1.169|18.354|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||18.354|1.169|0.029
71706470|NCT00286455|142930178|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.102
71706471|NCT00286455|142930178|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.063
71706472|NCT00286455|142930179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.18|0.186
71706473|NCT00286455|142930179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.237|TWO_SIDED|95.0|-0.22|0.89||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.89|-0.22|0.237
71706474|NCT00286455|142930180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.702|TWO_SIDED|95.0|-0.74|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.50|-0.74|0.702
71706475|NCT00286455|142930180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.338|TWO_SIDED|95.0|-0.32|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.93|-0.32|0.338
71706476|NCT00286455|142930181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.978|TWO_SIDED|95.0|-0.74|0.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.72|-0.74|0.978
71764680|NCT03054129|143031532|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
71764681|NCT03054129|143031533|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
71826171|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.61|||<|0.001|TWO_SIDED|95.0|1.9|3.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.33|1.90|<0.001
71826172|NCT01362491|143156833|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.547|TWO_SIDED|95.0|-0.77|0.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.41|-0.77|0.547
71826173|NCT01362491|143156834|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.16|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
71826174|NCT01362491|143156834|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.83|<0.001
71826175|NCT01362491|143156834|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.0||||0.992|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.27|-0.28|0.992
71654148|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.||||<0.001
71654149|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||<0.001
71654150|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.003||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.||||0.003
71654151|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||<0.001
71654152|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.||||||0.071||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.||||0.071
71654153|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
71654154|NCT00262041|142825304|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001||95.0|||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.||||<0.001
71654155|NCT02384941|142825317|SUPERIORITY||Least squares mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|||||Threshold for significance \< 0.05.|MMRM|||||||<0.001
71706477|NCT00286455|142930181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.73|0.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.74|-0.73|0.991
71826176|NCT01362491|143156834|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.01|||<|0.001|TWO_SIDED|95.0|1.43|2.58||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.58|1.43|<0.001
71764682|NCT03054129|143031534|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
71764683|NCT03054129|143031535|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
71764684|NCT03054129|143031536|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
71764685|NCT03054129|143031537|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
71764686|NCT03054129|143031538|SUPERIORITY|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||||||0.097
71764687|NCT03054129|143031539|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
71764688|NCT03054129|143031540|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71764689|NCT03054129|143031541|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
71764690|NCT03054129|143031542|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
71764691|NCT03054129|143031543|SUPERIORITY|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
71764692|NCT03054129|143031544|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
71764693|NCT03054129|143031545|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.040
71764694|NCT03054129|143031546|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
71764695|NCT03054129|143031547|SUPERIORITY|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
71764696|NCT03054129|143031548|SUPERIORITY|||||||0.129|||||||Wilcoxon (Mann-Whitney)|||||||0.129
71764697|NCT03054129|143031549|SUPERIORITY|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
71764698|NCT03054129|143031550|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||0.978
71764699|NCT03054129|143031551|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
71764700|NCT03054129|143031552|SUPERIORITY|||||||0.546|||||||Wilcoxon (Mann-Whitney)|||||||0.546
71764701|NCT03054129|143031553|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
71764702|NCT03054129|143031554|SUPERIORITY|||||||0.684|||||||Wilcoxon (Mann-Whitney)|||||||0.684
71764703|NCT03054129|143031555|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||0.112
71764704|NCT03054129|143031556|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71764705|NCT03054129|143031557|SUPERIORITY|||||||0.633|||||||Wilcoxon (Mann-Whitney)|||||||0.633
71764706|NCT03054129|143031558|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||||||0.736
71764707|NCT03054129|143031559|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71764708|NCT03054129|143031560|SUPERIORITY|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
71764709|NCT03054129|143031561|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
71764710|NCT03054129|143031562|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.122
71764711|NCT03054129|143031563|SUPERIORITY|||||||0.715|||||||Wilcoxon (Mann-Whitney)|||||||0.715
71764712|NCT03054129|143031564|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
71764713|NCT03054129|143031565|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
71764714|NCT00130247|143031566|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.051||||||95.0|0.01|0.09|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|Comparison of binomial proportion of relapse: Intention-to-treat||0.09|0.01|
71764715|NCT00130247|143031569|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.43||||||95.0|0.94|12.5|||Regression, Linear|||Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.||12.5|0.94|
71764716|NCT00130247|143031569|SUPERIORITY_OR_OTHER||Incident rate ratio|4.52||||||95.0|1.29|15.9|||Regression, Linear|||Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.||15.9|1.29|
71764717|NCT00130247|143031575|NON_INFERIORITY_OR_EQUIVALENCE|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.054||||||95.0|0.01|0.1|||Regression, Cox||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|||0.10|0.01|
71764718|NCT02123251|143031577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.2139||0.0553|TWO_SIDED|95.0|-0.0092|0.8293|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, race, gender, and baseline hypertension.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||0.8293|-0.0092|0.0553
71764719|NCT02123251|143031578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2916|STANDARD_ERROR_OF_MEAN|1.9571||0.2416|TWO_SIDED|95.0|-6.1274|1.5442|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.5442|-6.1274|0.2416
71764720|NCT02123251|143031579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0893|STANDARD_ERROR_OF_MEAN|1.2622||0.3881|TWO_SIDED|95.0|-3.5632|1.3846|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||1.3846|-3.5632|0.3881
71826177|NCT01362491|143156834|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.68||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.68|1.53|<0.001
71764721|NCT02123251|143031580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3432|STANDARD_ERROR_OF_MEAN|7.7086||0.8617|TWO_SIDED|95.0|-16.4517|13.7653|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||13.7653|-16.4517|0.8617
71826178|NCT01362491|143156834|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.1||||0.684|TWO_SIDED|95.0|-0.57|0.38||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.38|-0.57|0.684
71826179|NCT01362491|143156835|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.85|3.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.17|1.85|<0.001
71764722|NCT02123251|143031581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.787|STANDARD_ERROR_OF_MEAN|28.5519||0.5333|TWO_SIDED|95.0|-73.7478|38.1737|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||38.1737|-73.7478|0.5333
71826180|NCT01362491|143156835|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|2.49|||<|0.001|TWO_SIDED|95.0|1.83|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.15|1.83|<0.001
71654156|NCT02384941|142825317|SUPERIORITY||Least squares mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0||||Threshold for significance \< 0.05.|MMRM|||||||< 0.001
71654157|NCT02384941|142825318|SUPERIORITY||Percentage difference|11.8||||0.002|TWO_SIDED|95.0|4.28|19.36||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint of each treatment comparison was statistically significant at 0.05 level.||19.36|4.28|0.002
71654158|NCT02384941|142825318|SUPERIORITY||Percentage difference|21.9|||<|0.001|TWO_SIDED|95.0|14.1|29.64||Threshold for significance \< 0.05.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||29.64|14.10|< 0.001
71654159|NCT02384941|142825319|SUPERIORITY||Least squares mean difference|-2.35|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-2.85|-1.85||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.85|-2.85|< 0.001
71654160|NCT02384941|142825319|SUPERIORITY||Least squares mean difference|-3.45|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-3.95|-2.94||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-2.94|-3.95|< 0.001
71654161|NCT02384941|142825320|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.917||0.1|TWO_SIDED|95.0|-3.3|0.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.30|-3.30|0.10
71654162|NCT02384941|142825320|SUPERIORITY||Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.916|<|0.001|TWO_SIDED|95.0|-5.09|-1.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-1.50|-5.09|< 0.001
71654163|NCT02384941|142825321|SUPERIORITY||Least squares mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.48||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.48|-1.50|< 0.001
71654164|NCT02384941|142825322|SUPERIORITY||Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.8|3.3||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||3.3|1.8|< 0.001
71706478|NCT00286455|142930182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.539|TWO_SIDED|95.0|-1.16|0.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.61|-1.16|0.539
71706479|NCT00286455|142930182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.379|TWO_SIDED|95.0|-1.29|0.49||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.49|-1.29|0.379
71706480|NCT00286455|142930183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.616|TWO_SIDED|95.0|-4.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-4.4|0.616
71706481|NCT00286455|142930183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.4|0.930
71706482|NCT00286455|142930184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.915|TWO_SIDED|95.0|-5.3|6.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.0|-5.3|0.915
71706483|NCT00286455|142930184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.745|TWO_SIDED|95.0|-4.8|6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-4.8|0.745
71706484|NCT00286455|142930185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.466|TWO_SIDED|95.0|-3.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.5|-3.4|0.466
71706485|NCT00286455|142930185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.154|TWO_SIDED|95.0|-1.5|9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.6|-1.5|0.154
71764723|NCT02123251|143031582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9097|STANDARD_ERROR_OF_MEAN|5.2351||0.862|TWO_SIDED|95.0|-9.3509|11.1702|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||11.1702|-9.3509|0.8620
71706486|NCT00286455|142930186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.774|TWO_SIDED|95.0|-5.1|6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.9|-5.1|0.774
71706487|NCT00286455|142930186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.761|TWO_SIDED|95.0|-5.2|7.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.1|-5.2|0.761
71764724|NCT02123251|143031583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7177|STANDARD_ERROR_OF_MEAN|1.0433||0.4915|TWO_SIDED|95.0|-1.3272|2.7626|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.||2.7626|-1.3272|0.4915
71706488|NCT00286455|142930187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.559|TWO_SIDED|95.0|-4.2|7.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.7|-4.2|0.559
71706489|NCT00286455|142930187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.523|TWO_SIDED|95.0|-4.1|8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.0|-4.1|0.523
71654165|NCT02384941|142825323|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.0|-0.5||Threshold for significance \< 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-0.5|-1.0|< 0.001
71654166|NCT00484419|142825375|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0061
71654167|NCT00484419|142825375|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.1090
71654168|NCT00484419|142825375|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
71706490|NCT00286455|142930188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.739|TWO_SIDED|95.0|-7.4|5.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.2|-7.4|0.739
71654169|NCT00484419|142825376|SUPERIORITY_OR_OTHER|||||||0.0234||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0234
71654170|NCT00484419|142825376|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||<0.0001
71654171|NCT00484419|142825376|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.||||0.0011
71654172|NCT00484419|142825379|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0077
71654173|NCT00484419|142825379|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
71706491|NCT00286455|142930188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.388|TWO_SIDED|95.0|-9.3|3.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.6|-9.3|0.388
71706492|NCT04826731|142930189|OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.374
71706493|NCT04826731|142930190|OTHER|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.||||0.635
71706494|NCT04359680|142930201|SUPERIORITY||Odds Ratio (OR)|1.029||||0.9434|TWO_SIDED|95.0|0.4696|2.2546|||Cochran-Mantel-Haenszel|||||2.2546|0.4696|0.9434
71706495|NCT04359680|142930202|SUPERIORITY||Odds Ratio (OR)|1.1162||||0.6805|TWO_SIDED|95.0|0.6623|1.8813|||Cochran-Mantel-Haenszel|||||1.8813|0.6623|0.6805
71706496|NCT04359680|142930204|SUPERIORITY|||||||0.3459|||||||Cochran-Mantel-Haenszel|||||||0.3459
71706497|NCT03931785|142930215|SUPERIORITY||Least squares (LS) mean difference|0.08||||0.7467|TWO_SIDED|95.0|-0.42|0.58|||MMRM||MD-7246 minus placebo|||0.58|-0.42|0.7467
71706498|NCT03931785|142930215|SUPERIORITY||LS mean difference|0.43||||0.0941|TWO_SIDED|95.0|-0.07|0.93|||MMRM||MD-7246 minus placebo|||0.93|-0.07|0.0941
71706499|NCT03931785|142930215|SUPERIORITY||LS mean difference|0.06||||0.8098|TWO_SIDED|95.0|-0.44|0.56|||MMRM||MD-7246 minus placebo|||0.56|-0.44|0.8098
71706500|NCT03931785|142930216|SUPERIORITY||Difference in Responder Rate|1.0|||||TWO_SIDED|95.0|-12.9|15.0|||||Difference in responder rate (MD-7246 - placebo). 95% confidence intervals (CIs) for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||15.0|-12.9|
71706501|NCT03931785|142930216|SUPERIORITY||Difference in Responder Rate|-11.3|||||TWO_SIDED|95.0|-25.3|2.6|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||2.6|-25.3|
71706502|NCT03931785|142930216|SUPERIORITY||Difference in Responder Rate|-7.2|||||TWO_SIDED|95.0|-21.2|6.8|||||Difference in responder rate (MD-7246 - placebo). 95% CIs for differences in responder rates were obtained using the normal approximation to the binomial distribution.|||6.8|-21.2|
71706503|NCT03931785|142930216|SUPERIORITY||Odds Ratio (OR)|1.043||||0.8852|TWO_SIDED|95.0|0.591|1.839|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.839|0.591|0.8852
71706504|NCT03931785|142930216|SUPERIORITY||Odds Ratio (OR)|0.634||||0.1152|TWO_SIDED|95.0|0.36|1.117|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.117|0.360|0.1152
71706505|NCT03931785|142930216|SUPERIORITY||Odds Ratio (OR)|0.749||||0.3157|TWO_SIDED|95.0|0.425|1.317|||Cochran-Mantel-Haenszel||Odds ratio for response (MD-7246 : placebo)|||1.317|0.425|0.3157
71826181|NCT01362491|143156835|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.943|TWO_SIDED|95.0|-0.52|0.56||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.56|-0.52|0.943
71826182|NCT01362491|143156835|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.03|5.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|3.03|<0.001
71826183|NCT01362491|143156835|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.09|5.24||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen (Motrin IB) - Placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.24|3.09|<0.001
71826184|NCT01362491|143156835|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.06||||0.888|TWO_SIDED|95.0|-0.95|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.95|0.888
71826185|NCT01362491|143156836|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.71|4.64||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.64|2.71|<0.001
71826186|NCT01362491|143156836|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|3.66|||<|0.001|TWO_SIDED|95.0|2.68|4.63||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.63|2.68|<0.001
71826187|NCT01362491|143156836|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.02||||0.964|TWO_SIDED|95.0|-0.78|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.82|-0.78|0.964
71826188|NCT01362491|143156836|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|6.27|||<|0.001|TWO_SIDED|95.0|4.65|7.89||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.89|4.65|<0.001
71826189|NCT01362491|143156836|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.16||||0.812|TWO_SIDED|95.0|-1.49|1.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.17|-1.49|0.812
71706506|NCT02504775|142930217|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|94.704|||||TWO_SIDED|90.0|88.329|101.54|||ANOVA|||||101.540|88.329|
71706507|NCT02504775|142930218|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|95.989|||||TWO_SIDED|90.0|89.826|102.574|||ANOVA|||||102.574|89.826|
71706508|NCT02504775|142930219|NON_INFERIORITY_OR_EQUIVALENCE|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|106.132|||||TWO_SIDED|90.0|85.151|132.283|||ANOVA|||||132.283|85.151|
71826190|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|12.02||||0.015|TWO_SIDED|95.0|5.27|18.77||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|5.27|0.015
71826191|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|4.5||||0.146|TWO_SIDED|95.0|0.13|8.88||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.88|0.13|0.146
71826192|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|7.62||||0.064|TWO_SIDED|95.0|-0.38|15.63||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.63|-0.38|0.064
71706509|NCT01230814|142930222|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.69|TWO_SIDED|95.0|0.62|1.37||The a priori threshold for statistical significance for VVC was p\<0.020 (two-sided).|Clustered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of positive test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which VVC was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||1.37|0.62|0.690
71706510|NCT01230814|142930223|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.005|TWO_SIDED|95.0|0.48|0.87||The a priori threshold for statistical significance for BV was p\<0.030 (two-sided).|clutstered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk \<1 indicates a lower percentage of test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which BV was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).||0.87|0.48|0.005
71706511|NCT02596893|142930240|SUPERIORITY||Stratified Difference|-2.9||||0.2523|TWO_SIDED|95.0|-9.7|3.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||3.9|-9.7|0.2523
71706512|NCT02596893|142930240|SUPERIORITY||Slope|4.8||||0.1626|TWO_SIDED|95.0|-3.0|11.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||11.8|-3.0|0.1626
71706513|NCT02596893|142930240|SUPERIORITY||Stratified Difference|-2.1||||0.442|TWO_SIDED|95.0|-9.1|5.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.3|-9.1|0.4420
71706514|NCT02596893|142930241|SUPERIORITY||Stratified Difference|-2.6||||0.1799|TWO_SIDED|95.0|-9.5|5.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.0|-9.5|0.1799
71706515|NCT02596893|142930241|SUPERIORITY||Stratified Difference|-2.4||||0.2309|TWO_SIDED|95.0|-9.4|4.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.9|-9.4|0.2309
71706516|NCT02596893|142930241|SUPERIORITY||Stratified Difference|-2.1||||0.3264|TWO_SIDED|95.0|-9.1|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||4.6|-9.1|0.3264
71706517|NCT02596893|142930242|SUPERIORITY||Stratified Difference|-11.7||||0.0299|TWO_SIDED|95.0|-22.0|-1.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.1|-22.0|0.0299
71706518|NCT02596893|142930242|SUPERIORITY||Stratified difference|-9.9||||0.0582|TWO_SIDED|95.0|-20.3|0.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||0.7|-20.3|0.0582
71706519|NCT02596893|142930242|SUPERIORITY||Stratified difference|-9.7||||0.0741|TWO_SIDED|95.0|-20.1|1.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||1.0|-20.1|0.0741
71706520|NCT02596893|142930243|SUPERIORITY||Stratified difference|-5.8||||0.2493|TWO_SIDED|95.0|-15.5|4.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.0|-15.5|0.2493
71706521|NCT02596893|142930243|SUPERIORITY||Stratified difference|-1.8||||0.716|TWO_SIDED|95.0|-11.8|8.2|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||8.2|-11.8|0.7160
71706522|NCT02596893|142930243|SUPERIORITY||Stratified difference|-5.8||||0.2452|TWO_SIDED|95.0|-15.5|4.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.1|-15.5|0.2452
71706523|NCT02596893|142930244|SUPERIORITY||Stratified difference|-1.3||||0.7541|TWO_SIDED|95.0|-9.8|7.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||7.1|-9.8|0.7541
71706524|NCT02596893|142930244|SUPERIORITY||Stratified difference|-3.7||||0.3784|TWO_SIDED|95.0|-12.0|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||4.6|-12.0|0.3784
71706525|NCT02596893|142930244|SUPERIORITY||Stratified difference|-4.4||||0.2865|TWO_SIDED|95.0|-12.6|3.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||3.8|-12.6|0.2865
71706526|NCT02596893|142930245|SUPERIORITY||Unstratified CMH|-2.2||||0.3572|TWO_SIDED|95.0|-11.3|7.0|||Cochran-Mantel-Haenszel|p-values were based on the unstratified CMH test when 1 and only 1 of the 2 treatment groups being compared had no subjects in a stratum.|The weighted average of the treatment differences across the strata with the CMH weights.|2-sided 95% CI were based on the unstratified Newcombe method.||7.0|-11.3|0.3572
71706527|NCT02596893|142930245|SUPERIORITY||Stratified difference|4.7||||0.2823|TWO_SIDED|95.0|-8.8|18.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||18.9|-8.8|0.2823
71706528|NCT02596893|142930245|SUPERIORITY||Stratified difference|0.0|||>|0.9999|TWO_SIDED|95.0|-12.8|13.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||13.7|-12.8|> 0.9999
71706529|NCT02596893|142930246|SUPERIORITY||Stratified difference|-0.5||||0.8031|TWO_SIDED|95.0|-6.7|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.9|-6.7|0.8031
71706530|NCT02596893|142930246|SUPERIORITY||Stratified difference|1.4||||0.5583|TWO_SIDED|95.0|-5.1|7.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||7.3|-5.1|0.5583
71706531|NCT02596893|142930246|SUPERIORITY||Stratified difference|-1.0||||0.6123|TWO_SIDED|95.0|-7.2|6.8|||Cochran-Mantel-Haenszel||||The weighted average of the treatment differences across the strata with the CMH weights.|6.8|-7.2|0.6123
71706532|NCT02596893|142930247|SUPERIORITY||Stratified difference|-10.6||||0.0239|TWO_SIDED|95.0|-19.6|-1.4|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||-1.4|-19.6|0.0239
71826193|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|58.58|||<|0.001|TWO_SIDED|95.0|44.96|72.21||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.21|44.96|<0.001
71826194|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|52.31|||<|0.001|TWO_SIDED|95.0|38.2|66.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||66.41|38.20|<0.001
71826195|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|6.4||||0.357|TWO_SIDED|95.0|-7.27|20.07||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.07|-7.27|0.357
71826196|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|46.68|||<|0.001|TWO_SIDED|95.0|30.43|62.93||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.93|30.43|<0.001
71826197|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|47.59|||<|0.001|TWO_SIDED|95.0|31.35|63.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.83|31.35|<0.001
71826198|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
71826199|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
71826200|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
71826201|NCT01362491|143156837|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
71826202|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|18.58||||0.002|TWO_SIDED|95.0|10.43|26.73||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.73|10.43|0.002
71826203|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|7.8||||0.055|TWO_SIDED|95.0|2.14|13.46||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.46|2.14|0.055
71826204|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|10.91||||0.033|TWO_SIDED|95.0|0.98|20.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.83|0.98|0.033
71826205|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|62.03|||<|0.001|TWO_SIDED|95.0|48.65|75.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.41|48.65|<0.001
71826206|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|59.44|||<|0.001|TWO_SIDED|95.0|45.69|73.19||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.19|45.69|<0.001
71706533|NCT02596893|142930247|SUPERIORITY||Stratified difference|-1.0||||0.8334|TWO_SIDED|95.0|-10.8|8.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||8.7|-10.8|0.8334
71706534|NCT02596893|142930247|SUPERIORITY||Stratified difference|-3.9||||0.4383|TWO_SIDED|95.0|-13.5|5.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.|||5.8|-13.5|0.4383
71706535|NCT02596893|142930248|SUPERIORITY||Stratified difference|-1.6||||0.3573|TWO_SIDED|95.0|-8.3|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with CMH weights.|||5.9|-8.3|0.3573
71706536|NCT02596893|142930248|SUPERIORITY||Stratified difference|-2.0||||0.2221|TWO_SIDED|95.0|-8.7|5.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.1|-8.7|0.2221
71706537|NCT02596893|142930248|SUPERIORITY||Stratified difference|-2.0||||0.2578|TWO_SIDED|95.0|-8.7|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-8.7|0.2578
71706538|NCT02596893|142930251|SUPERIORITY||Stratified Difference|0.5||||0.9141|TWO_SIDED|95.0|-8.9|10.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights|||10.0|-8.9|0.9141
71706539|NCT02596893|142930251|SUPERIORITY||Stratified Difference|-3.6||||0.4286|TWO_SIDED|95.0|-12.8|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||5.6|-12.8|0.4286
71706540|NCT02596893|142930251|SUPERIORITY||Stratified Difference|-2.7||||0.5591|TWO_SIDED|95.0|-12.0|6.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.|||6.6|-12.0|0.5591
71706541|NCT03052257|142930252|SUPERIORITY||Median Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.15|0.3|||Regression, Linear|||||0.30|0.15|<0.0001
71706542|NCT02255279|142930277|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|3.0|5.51|||ANCOVA|||Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to \< 72 months of Age.||5.51|3.00|
71706543|NCT02255279|142930277|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|2.05|3.25|||ANCOVA|||Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||3.25|2.05|
71706544|NCT02255279|142930277|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi \>-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV \& TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is \>0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.67|||||TWO_SIDED|95.0|3.52|6.2|||ANCOVA|||Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to \< 72 months of Age.||6.20|3.52|
71706545|NCT02255279|142930278|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|17.0|||||TWO_SIDED|95.0|8.1|26.3|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.||26.3|8.1|
71706546|NCT02255279|142930278|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|-1.8|21.0|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.||21|-1.8|
71706547|NCT02255279|142930278|NON_INFERIORITY_OR_EQUIVALENCE|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 \> πi2-0.1 vs. H1i: πi1 \> πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|58.0|||||TWO_SIDED|95.0|47.5|68.5|||Loglinear model|Binary data were analyzed using loglinear models with a qualitative factor for vaccine group (αik, i = A, B) and center (δlk, k=1).||Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.||68.5|47.5|
71706548|NCT02123511|142930316|SUPERIORITY|||||||0.1232|||||||t-test, 1 sided|||||||0.1232
71706549|NCT02123511|142930317|SUPERIORITY|||||||0.0422|||||||t-test, 1 sided|||||||0.0422
71706550|NCT02123511|142930318|SUPERIORITY|||||||0.5634|||||||t-test, 1 sided|||||||0.5634
71706551|NCT02123511|142930319|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
71826207|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|2.96||||0.642|TWO_SIDED|95.0|-9.52|15.44||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.44|-9.52|0.642
71826208|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
71654174|NCT00484419|142825379|SUPERIORITY_OR_OTHER|||||||0.0483||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0483
71706552|NCT02123511|142930320|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|||||||0.22
71706553|NCT02123511|142930321|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||0.02
71706554|NCT02123511|142930322|SUPERIORITY|||||||0.95|||||||t-test, 1 sided|||||||0.95
71706555|NCT02123511|142930323|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||||||0.17
71706556|NCT02123511|142930324|SUPERIORITY|||||||0.48|||||||t-test, 1 sided|||||||0.48
71706557|NCT02123511|142930325|SUPERIORITY|||||||0.3824|||||||Wilcoxon (Mann-Whitney)|||||||0.3824
71706558|NCT01750281|142930332|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.12||||0.584|TWO_SIDED|90.0|0.8|1.61|||Cox Proportional Hazards|||||1.61|0.80|0.584
71706559|NCT01750281|142930332|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|0.92||||0.69|TWO_SIDED|90.0|0.65|1.31|||Cox Proportional Hazards|||||1.31|0.65|0.690
71706560|NCT01750281|142930333|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.43||||0.126|TWO_SIDED|90.0|0.97|2.13|||Cox Proportional Hazards|||||2.13|0.97|0.126
71706561|NCT01750281|142930333|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hazard ratio \<1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.18||||0.485|TWO_SIDED|90.0|0.8|1.78|||Cox Proportional Hazards|||||1.78|0.80|0.485
71706562|NCT01122680|142930336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.036|0.19||First step of closed testing procedure, where the active treatments are compared to placebo. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Placebo||0.190|0.036|0.0043
71654175|NCT00484419|142825380|SUPERIORITY_OR_OTHER|||||||0.0133||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0133
71654176|NCT00484419|142825380|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0004
71654177|NCT00484419|142825380|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0125
71654178|NCT00484419|142825383|SUPERIORITY_OR_OTHER|||||||0.8596||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.8596
71654179|NCT00484419|142825383|SUPERIORITY_OR_OTHER|||||||0.0257||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0257
71654180|NCT00484419|142825383|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1862
71706563|NCT01122680|142930336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.039||0.1484||95.0|-0.021|0.135||Second step of closed testing procedure. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Placebo||0.135|-0.021|0.1484
71706564|NCT01122680|142930336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.036||0.0664||95.0|-0.005|0.138||This test is considered as descriptive.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.138|-0.005|0.0664
71706565|NCT01122680|142930336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.039||||95.0|-0.031|0.124|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R1.25||0.124|-0.031|
71706566|NCT01122680|142930336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.036||||95.0|-0.014|0.126|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Tio R2.5||0.126|-0.014|
71706567|NCT01122680|142930336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.088|0.069|||Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Tio R1.25||0.069|-0.088|
71706568|NCT01550965|142930350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||paired t-test, 2 sided|||Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||18.73|16.08|<0.001
71706569|NCT01550965|142930351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1383.81|||<|0.001|TWO_SIDED|95.0|-1586.36|-1181.26|||Paired t-test, 2 sided|||Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.||-1181.26|-1586.36|<0.001
71706570|NCT01550965|142930352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1297.77|||<|0.001|TWO_SIDED|95.0|-1562.17|-1033.36|||Paired t-test, 2 sided|||||-1033.36|-1562.17|<0.001
71764725|NCT02123251|143031584|SUPERIORITY_OR_OTHER||||||>|0.05|||||||standard diffs-in-diffs model|||A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.||||>0.05
71764726|NCT02123251|143031585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6403|STANDARD_ERROR_OF_MEAN|0.3148||0.042|TWO_SIDED|95.0|0.0233|1.2572|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.||1.2572|0.0233|0.0420
71764727|NCT02123251|143031586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1188|STANDARD_ERROR_OF_MEAN|1.031||0.0399|TWO_SIDED|95.0|0.0981|4.1395|||Generalized Estimating Equation Model|The effect of age and gender is adjusted in the GEE model.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.||4.1395|0.0981|.0399
71764728|NCT00966875|143031595|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||A log transformed dose was used in the model.|Regression, Logistic|||||||0.031
71764729|NCT00966875|143031596|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Fisher Exact|||||||0.033
71764730|NCT00966875|143031596|SUPERIORITY_OR_OTHER|||||||0.047|||||||Fisher Exact|||||||0.047
71764731|NCT00966875|143031600|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
71764732|NCT00966875|143031600|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
71764733|NCT00966875|143031600|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764734|NCT00966875|143031600|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764735|NCT00966875|143031600|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764736|NCT00966875|143031600|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764737|NCT00966875|143031600|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764738|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.227
71764739|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.306
71764740|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.001
71764741|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.070
71764742|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.058
71764743|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.033
71764744|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||P-value is for ACR20-NRI at Week 12.|Fisher Exact|||||||0.047
71764745|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.191
71764746|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.019
71764747|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.013
71764748|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.017
71764749|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.026
71764750|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.039
71764751|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||P-value is for ACR50-NRI at Week 12.|Fisher Exact|||||||0.102
71764752|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.388|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.388
71764753|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.033
71764754|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
71764755|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.199
71764756|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.039
71764757|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.696|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.696
71764758|NCT00966875|143031602|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||P-value is for ACR70-NRI at Week 12.|Fisher Exact|||||||0.112
71764759|NCT00966875|143031604|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
71764760|NCT00966875|143031604|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
71654181|NCT00484419|142825384|SUPERIORITY_OR_OTHER|||||||0.7094||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.7094
71706571|NCT01550965|142930353|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4308.32|||<|0.001|TWO_SIDED|95.0|-4985.13|-3631.51|||Paired t-test, 2 sided|||||-3631.51|-4985.13|<0.001
71706572|NCT01550965|142930354|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|||<|0.001|TWO_SIDED|95.0|-9.83|-4.78|||Paired t-test, 2 sided|||||-4.78|-9.83|<0.001
71706573|NCT01550965|142930355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|||<|0.001|TWO_SIDED|95.0|21.5|27.25|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.||27.25|21.50|<0.001
71706574|NCT01550965|142930355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.95|||<|0.001|TWO_SIDED|95.0|15.42|22.48|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.||22.48|15.42|<0.001
71706575|NCT01550965|142930355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|||<|0.001|TWO_SIDED|95.0|3.89|8.5|||Paired t-test, 2 sided)|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.||8.50|3.89|<0.001
71764761|NCT00966875|143031604|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.004
71654182|NCT00484419|142825384|SUPERIORITY_OR_OTHER|||||||0.1394||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1394
71654183|NCT00484419|142825384|SUPERIORITY_OR_OTHER|||||||0.4528||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.4528
71654184|NCT00484419|142825386|SUPERIORITY_OR_OTHER|||||||0.0374||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0374
71654185|NCT00484419|142825386|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
71654186|NCT00484419|142825386|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0001
71654187|NCT00484419|142825387|SUPERIORITY_OR_OTHER|||||||0.2701||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2701
71654188|NCT00484419|142825387|SUPERIORITY_OR_OTHER|||||||0.6117||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.6117
71654189|NCT00484419|142825387|SUPERIORITY_OR_OTHER|||||||0.2007||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.2007
71654190|NCT00484419|142825389|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
71654191|NCT00484419|142825389|SUPERIORITY_OR_OTHER|||||||0.1864||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.1864
71654192|NCT00484419|142825389|SUPERIORITY_OR_OTHER|||||||0.0999||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0999
71654193|NCT00484419|142825390|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||<0.0001
71654194|NCT00484419|142825390|SUPERIORITY_OR_OTHER|||||||0.0566||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0566
71654195|NCT00484419|142825390|SUPERIORITY_OR_OTHER|||||||0.0217||95.0|||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.||||0.0217
71654196|NCT03176784|142825416|SUPERIORITY||Odds Ratio (OR)|0.9||||0.66|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.66
71654197|NCT03176784|142825416|SUPERIORITY||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|.85
71654198|NCT03176784|142825416|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.4|0.7|1.00
71654199|NCT03176784|142825417|SUPERIORITY||Odds Ratio (OR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.7||Study site (Madison vs Milwaukee) was included as a covariate.|Regression, Logistic|||||1.7|0.8|.44
71654200|NCT03176784|142825417|SUPERIORITY||Odds Ratio (OR)|1.1||||0.61|TWO_SIDED|95.0|0.8|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.8|.61
71654201|NCT03176784|142825417|SUPERIORITY||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.0|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||2.0|0.9|.12
71654202|NCT03176784|142825418|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.43
71654203|NCT03176784|142825418|SUPERIORITY||Odds Ratio (OR)|0.8||||0.37|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.5|.37
71654204|NCT03176784|142825418|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.6|0.7|.81
71654205|NCT03176784|142825419|SUPERIORITY||Odds Ratio (OR)|0.9||||0.65|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.65
71654206|NCT03176784|142825419|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.3|0.6|.60
71654207|NCT03176784|142825419|SUPERIORITY||Odds Ratio (OR)|1.0||||0.86|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|Study site (Madison vs Milwaukee) was included as a covariate.||||1.5|0.7|.86
71654208|NCT00904748|142825421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|98.68|||||TWO_SIDED|90.0|92.03|105.82|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.82|92.03|
71826209|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
71826210|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
71826211|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|40.26|||<|0.001|TWO_SIDED|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||56.68|23.85|<0.001
71826212|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|41.19|||<|0.001|TWO_SIDED|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||57.59|24.78|<0.001
71826213|NCT01362491|143156838|SUPERIORITY_OR_OTHER||Difference in proportion|-0.72||||0.889|TWO_SIDED|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.45|-10.89|0.889
71826214|NCT01362491|143156841|SUPERIORITY_OR_OTHER||Difference in proportion|3.21||||0.389|TWO_SIDED|95.0|-3.12|9.55||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.55|-3.12|0.389
71826215|NCT01362491|143156841|SUPERIORITY_OR_OTHER||Difference in proportion|2.35||||0.49|TWO_SIDED|95.0|-3.69|8.39||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.39|-3.69|0.490
71826216|NCT01362491|143156841|SUPERIORITY_OR_OTHER||Difference in proportion|0.98||||0.764|TWO_SIDED|95.0|-5.45|7.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.41|-5.45|0.764
71826217|NCT01362491|143156841|SUPERIORITY_OR_OTHER||Difference in proportion|28.71|||<|0.001|TWO_SIDED|95.0|15.72|41.7||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.70|15.72|<0.001
71826218|NCT01362491|143156841|SUPERIORITY_OR_OTHER||Difference in proportion|29.37|||<|0.001|TWO_SIDED|95.0|16.19|42.56||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen (Motrin IB) - placebo\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.56|16.19|<0.001
71826219|NCT01362491|143156841|SUPERIORITY_OR_OTHER||Difference in proportion|-0.93||||0.898|TWO_SIDED|95.0|-15.22|13.36||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen Sodium - Ibuprofen (Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|-15.22|0.898
71826220|NCT01257503|143156842|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in same participant||change in runny nose||||.86
71826221|NCT01257503|143156842|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in sneeze||||.89
71826222|NCT01257503|143156842|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in cough||||.45
71826223|NCT01257503|143156842|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in congestion||||.82
71826224|NCT01257503|143156843|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in irritability||||.61
71826225|NCT01257503|143156843|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in lethargy||||.97
71826226|NCT01257503|143156843|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in fussiness||||.79
71764762|NCT00966875|143031604|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71706576|NCT01550965|142930355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6|||<|0.001|TWO_SIDED|95.0|19.55|25.64|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.||25.64|19.55|<0.001
71706577|NCT01550965|142930356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.85|||<|0.001|TWO_SIDED|95.0|-5.42|-4.27|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization.||-4.27|-5.42|<0.001
71706578|NCT01550965|142930356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.11|0.09|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during emergency department visits.||0.09|-0.11|0.830
71706579|NCT01550965|142930356|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.18|-0.66|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.||-0.66|-1.18|<0.001
71706580|NCT01550965|142930357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||McNemar|||Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.||||<0.001
71706581|NCT01550965|142930358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||<|0.001|TWO_SIDED|95.0|10.21|12.02|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.||12.02|10.21|<0.001
71706582|NCT01550965|142930358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||<|0.001|TWO_SIDED|95.0|14.2|16.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.||16.56|14.20|<0.001
71706583|NCT01550965|142930358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.77|||<|0.001|TWO_SIDED|95.0|13.57|15.96|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||15.96|13.57|<0.001
71706584|NCT01550965|142930358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.001|TWO_SIDED|95.0|16.08|18.73|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.||18.73|16.08|<0.001
71706585|NCT01550965|142930359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 2.||-0.57|-0.69|<0.001
71706586|NCT01550965|142930359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001|TWO_SIDED|95.0|-1.16|-1.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 8.||-1.00|-1.16|<0.001
71706587|NCT01550965|142930359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-0.95|-0.77|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-0.77|-0.95|<0.001
71706588|NCT01550965|142930359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.23|-1.06|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 26.||-1.06|-1.23|<0.001
71706589|NCT01550965|142930360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|||<|0.001|TWO_SIDED|95.0|-3.46|-2.99|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 2.||-2.99|-3.46|<0.001
71706590|NCT01550965|142930360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06|||<|0.001|TWO_SIDED|95.0|-4.37|-3.76|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 8.||-3.76|-4.37|<0.001
71706591|NCT01550965|142930360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01|||<|0.001|TWO_SIDED|95.0|-3.36|-2.66|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-2.66|-3.36|<0.001
71706592|NCT01550965|142930360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|||<|0.001|TWO_SIDED|95.0|-4.43|-3.72|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 26.||-3.72|-4.43|<0.001
71706593|NCT01550965|142930361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.08|0.11|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.||0.11|0.08|<0.001
71706594|NCT01550965|142930361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001|TWO_SIDED|95.0|0.11|0.15|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.||0.15|0.11|<0.001
71706595|NCT01550965|142930361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.001|TWO_SIDED|95.0|0.1|0.14|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||0.14|0.10|<0.001
71706596|NCT01550965|142930361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.12|0.17|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.||0.17|0.12|<0.001
71706597|NCT01550965|142930362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-12.07|-5.18|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.||-5.18|-12.07|<0.001
71706598|NCT01550965|142930362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.27|-8.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.||-8.16|-16.27|<0.001
71706599|NCT01550965|142930362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.61|||<|0.001|TWO_SIDED|95.0|-15.82|-7.4|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-7.40|-15.82|<0.001
71706600|NCT01550965|142930362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-15.5|-7.35|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.||-7.35|-15.50|<0.001
71706601|NCT01550965|142930363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.56|||<|0.001|TWO_SIDED|95.0|-20.0|-13.12|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.||-13.12|-20.00|<0.001
71706602|NCT01550965|142930363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.95|||<|0.001|TWO_SIDED|95.0|-26.93|-18.97|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.||-18.97|-26.93|<0.001
71706603|NCT01550965|142930363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.68|||<|0.001|TWO_SIDED|95.0|-25.69|-17.67|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-17.67|-25.69|<0.001
71706604|NCT01550965|142930363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.45|||<|0.001|TWO_SIDED|95.0|-28.33|-20.58|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.||-20.58|-28.33|<0.001
71706605|NCT01550965|142930364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.34|||<|0.001|TWO_SIDED|95.0|-22.1|-14.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.||-14.57|-22.10|<0.001
71706606|NCT01550965|142930364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.54|||<|0.001|TWO_SIDED|95.0|-31.08|-22.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.||-22.00|-31.08|<0.001
71706607|NCT01550965|142930364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.33|||<|0.001|TWO_SIDED|95.0|-29.97|-20.7|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.||-20.70|-29.97|<0.001
71706608|NCT01550965|142930364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.22|||<|0.001|TWO_SIDED|95.0|-33.5|-24.93|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.||-24.93|-33.50|<0.001
71706609|NCT01550965|142930365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001|TWO_SIDED|95.0|-20.47|-15.85|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.||-15.85|-20.47|<0.001
71826227|NCT01257503|143156843|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in appetite||||.81
71826228|NCT01257503|143156844|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 1||||.16
71706610|NCT01550965|142930365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.43|||<|0.001|TWO_SIDED|95.0|-28.3|-22.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.||-22.56|-28.30|<0.001
71706611|NCT01550965|142930365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.42|||<|0.001|TWO_SIDED|95.0|-27.33|-21.5|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).||-21.50|-27.33|<0.001
71706612|NCT01550965|142930365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.22|||<|0.001|TWO_SIDED|95.0|-30.28|-24.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.||-24.16|-30.28|<0.001
71706613|NCT03760640|142930366|SUPERIORITY||LS Mean Difference|-0.86||||0.339|TWO_SIDED|90.0|-2.35|0.63|||Mixed Models Analysis|||||0.63|-2.35|0.339
71706614|NCT03760640|142930367|SUPERIORITY||LS Mean Difference|3.0||||0.011|TWO_SIDED|90.0|1.1|4.9|||Mixed Models Analysis|||||4.90|1.10|0.011
71706615|NCT03760640|142930368|SUPERIORITY||LS Mean Difference|0.56||||0.557|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||||2.14|-1.02|0.557
71706616|NCT03760640|142930369|SUPERIORITY||LS Mean Difference|-0.04||||0.548|TWO_SIDED|90.0|-0.15|0.07|||Mixed Models Analysis|||||0.07|-0.15|0.548
71706617|NCT03760640|142930371|SUPERIORITY||LS Mean Difference|0.49||||0.577|TWO_SIDED|90.0|-0.97|1.94|||Mixed Models Analysis|||||1.94|-0.97|0.577
71706618|NCT03016403|142930372|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0057|TWO_SIDED|95.0|0.52|2.98||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.98|0.52|0.0057
71706619|NCT03016403|142930373|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.0243|TWO_SIDED|95.0|0.19|2.73||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||2.73|0.19|0.0243
71764763|NCT00966875|143031604|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764764|NCT00966875|143031604|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
71764765|NCT00966875|143031604|SUPERIORITY_OR_OTHER|||||||0.007||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.007
71826229|NCT01257503|143156844|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 2||||.70
71826230|NCT01257503|143156844|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status day 3||||.77
71826231|NCT01257503|143156844|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||functional status at 7-10 day follow-up||||.41
71706620|NCT03016403|142930374|SUPERIORITY||Mean Difference (Final Values)|-15.31||||0.0061|TWO_SIDED|95.0|-26.23|-4.39||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.||-4.39|-26.23|0.0061
71706621|NCT03016403|142930375|SUPERIORITY||Mean Difference (Final Values)|-7.73||||0.21|TWO_SIDED|95.0|-19.73|4.27||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.27|-19.73|0.21
71706622|NCT03016403|142930376|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.052|TWO_SIDED|95.0|-0.01|3.05||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.05|-0.01|0.052
71706623|NCT03016403|142930377|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.214|TWO_SIDED|95.0|-0.52|2.36||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.36|-0.52|0.214
71706624|NCT03016403|142930378|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.0134|TWO_SIDED|95.0|-7.45|-0.87||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||-0.87|-7.45|0.0134
71706625|NCT03016403|142930379|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.42|TWO_SIDED|95.0|-0.9|2.12||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||2.12|-0.9|0.42
71738981|NCT00620113|142990731|SUPERIORITY_OR_OTHER||Difference in LS Means|3.08|||<|0.001|TWO_SIDED|95.0|1.85|4.31||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||4.31|1.85|<0.001
71764766|NCT00966875|143031606|SUPERIORITY_OR_OTHER|||||||0.093||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.093
71764767|NCT00966875|143031606|SUPERIORITY_OR_OTHER|||||||0.023||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.023
71764768|NCT00966875|143031606|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
71764769|NCT00966875|143031606|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
71764770|NCT00966875|143031606|SUPERIORITY_OR_OTHER|||||||0.028||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.028
71764771|NCT00966875|143031606|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764772|NCT00966875|143031606|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764773|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.247||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.247
71764774|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.315||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.315
71706626|NCT03016403|142930380|SUPERIORITY||Mean Difference (Final Values)|1.77||||0.0269|TWO_SIDED|95.0|0.2|3.34||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||3.34|0.2|0.0269
71706627|NCT03016403|142930381|SUPERIORITY||Mean Difference (Final Values)|2.56||||0.0044|TWO_SIDED|95.0|0.8|4.32||Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).|Mixed Models Analysis|The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).|The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.|A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.||4.32|0.8|0.0044
71706628|NCT00564070|142930387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.2|||<|0.0001|TWO_SIDED|95.0|17.37|42.9|||Mixed Models Analysis|General linear model, controlling for baseline values|The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.|Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)||42.9|17.37|<.0001
71706629|NCT00564070|142930388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||=|0.001|TWO_SIDED|95.0|0.29|1.15|||ANCOVA|General linear model; Controlling for baseline values|The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.|Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)||1.15|.29|=.001
71706630|NCT00564070|142930389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.22|31.14|||Mixed Models Analysis||The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.||31.14|10.22|<0.0001
71706631|NCT00564070|142930390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||=|0.002|TWO_SIDED|95.0|2.33|10.56|||Mixed Models Analysis|General linear model, controlling for baseline values.|The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.||10.56|2.33|=.002
71706632|NCT00564070|142930391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||=|0.01|TWO_SIDED|95.0|0.16|1.32|||ANCOVA|using GLM|The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.|||1.32|.16|=.01
71706633|NCT00564070|142930392|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|22.3|STANDARD_ERROR_OF_MEAN|7.0|=|0.002|TWO_SIDED|95.0|8.6|36.1|||Mixed Models Analysis|||We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU||36.1|8.6|=.002
71764775|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.006
71826232|NCT01257503|143156845|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 1||||.10
71826233|NCT01257503|143156845|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 2||||.28
71706634|NCT00564070|142930393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|5.0|=|0.001|TWO_SIDED|95.0|6.5|26.1|||Mixed Models Analysis|||We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU||26.1|6.5|=.001
71706635|NCT00564070|142930394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.1||0.16|TWO_SIDED|95.0|-1.2|7.2|||Mixed Models Analysis|||We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.||7.2|-1.2|.16
71706636|NCT00564070|142930395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1|TWO_SIDED|95.0|-0.1|1.1|||Mixed Models Analysis|||We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm||1.1|-.1|.10
71706637|NCT00564070|142930396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.29||0.03|TWO_SIDED|95.0|0.6|1.2|||Mixed Models Analysis|||We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.||1.2|.6|.03
71706638|NCT03142334|142930411|OTHER|HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.53|0.87|||Log Rank|One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.|Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.|||0.87|0.53|0.0010
71706639|NCT03071965|142930423|SUPERIORITY||Median Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.0881||0.5455|TWO_SIDED|95.0|-0.226|0.12|||Mixed Models Analysis|||||0.120|-0.226|0.5455
71706640|NCT05529173|142930437|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71826234|NCT01257503|143156845|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status day 3||||.26
71826235|NCT01257503|143156845|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||health status at follow-up||||.88
71826236|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 1||||.02
71826237|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 2||||.01
71706641|NCT03892915|142930493|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.73|1.93||||||||1.93|0.73|
71706642|NCT03892915|142930494|SUPERIORITY||beta coefficient|5.33|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|||||||||||||
71706643|NCT03892915|142930496|SUPERIORITY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.53|6.5||||||||6.50|0.53|
71826238|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||day 2 assessment 1||||.25
71706644|NCT03892915|142930497|SUPERIORITY||Odds Ratio (OR)|2.73|||||TWO_SIDED|95.0|0.45|16.64||||||||16.64|0.45|
71706645|NCT03892915|142930498|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.05|0.83||||||||0.83|0.05|
71706646|NCT01181128|142930504|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.13|||negative binomial model|||The null hypothesis for the primary endpoint is no difference between the individualized (tailored) prophylaxis regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 90% power at the 2-sided 0.05 level of significance to detect a 60% reduction in annualized bleeding episodes, based upon this hypothesis test.||0.13|0.05|<0.001
71706647|NCT01181128|142930510|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||negative binomial model|||||0.46|0.12|<0.001
71706648|NCT00185900|142930557|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71764776|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.042
71826239|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 2 assessment 2||||.15
71706649|NCT03193307|142930563|OTHER||Geometric Mean (T1/R1) ratio (%)|153.2|||||TWO_SIDED|90.0|134.34|174.7|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =21.4."|||174.70|134.34|
71706650|NCT03193307|142930564|OTHER||Geometric Mean (T1/R1) ratio (%)|115.91|||||TWO_SIDED|90.0|104.559|128.502|||||"Analysis of variance (ANOVA) including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 16.7."|||128.502|104.559|
71706651|NCT03193307|142930565|OTHER||Geometric Mean (T2/R2) ratio (%)|104.82|||||TWO_SIDED|90.0|102.092|107.613|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) =4.3."|||107.613|102.092|
71706652|NCT03193307|142930566|OTHER||Geometric Mean (T2/R2) ratio (%)|102.77|||||TWO_SIDED|90.0|100.66|104.92|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 3.3."|||104.92|100.66|
71706653|NCT03193307|142930567|OTHER||Geometric Mean (T2/R2) ratio (%)|114.12|||||TWO_SIDED|90.0|109.266|119.183|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\])=7.0."|||119.183|109.266|
71706654|NCT03193307|142930568|OTHER||Geometric Mean (T2/R2) ratio (%)|110.7|||||TWO_SIDED|90.0|105.8|115.83|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 7.3."|||115.83|105.80|
71706655|NCT03193307|142930569|OTHER||Geometric Mean (T1/R1) ratio (%)|154.15|||||TWO_SIDED|90.0|133.81|177.58|||||"Analysis of variance (ANOVA) model including random effect for 'subject' and fixed effect for 'treatment' was used.~Intra-individual geometric coefficient of variation (gCV \[%\]) = 22.4."|||177.58|133.81|
71706656|NCT00754559|142930570|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Exact Binomial Test|||Null hypothesis: Proportion of participants reaching LDAS (≤ 3.2) at Week 24 equals (=) expected proportion of 42%.||||<0.001
71706657|NCT04595370|142930644|OTHER||F test statistics|1.07||||0.3645|||||||F-Test|||||||0.3645
71706658|NCT04595370|142930645|OTHER||Percent difference between treatment|-33.606||||0.1588|TWO_SIDED|95.0|-62.53|17.644|||Mixed Models Analysis|||||17.644|-62.530|0.1588
71706659|NCT04595370|142930645|OTHER||Percent difference between treatment|-11.826||||0.6846|TWO_SIDED|95.0|-52.195|62.634|||Mixed Models Analysis|||||62.634|-52.195|0.6846
71706660|NCT04595370|142930645|OTHER||Percent difference between treatment|-36.127||||0.1398|TWO_SIDED|95.0|-64.85|16.066|||Mixed Models Analysis|||||16.066|-64.850|0.1398
71706661|NCT04913675|142930651|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM dose versus 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A post-hoc weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|1.06|||||TWO_SIDED|95.0|-1.15|3.26|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.26|-1.15|
71706662|NCT04913675|142930651|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of 500 mg IM vs 500 mg IV using a non-inferiority margin of 3.5 percent (%) on the risk difference scale. A pre-specified daily imputation algorithm imputed the missing outcome iteratively for each study day starting with Day 2 and ending at Day 29.|Risk Difference (RD)|1.16|||||TWO_SIDED|95.0|-1.23|3.56|||||Analysis was performed using a binomial regression model with identity link function and with treatment (Sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old) and gender (male, female) as covariates.|||3.56|-1.23|
71706663|NCT04913675|142930669|NON_INFERIORITY|This outcome measure was analyzed using a hypothetical estimand and assessing non-inferiority of IM dose versus IV using a non-inferiority margin of 3.5% on the risk difference scale. Weekly imputation algorithm imputes the missing outcome iteratively for each week, where missing outcomes at Day 8, 15, 22, 29 are imputed.|Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|-1.56|3.28|||||Post-hoc analysis was performed using a binomial regression model with identify link function and with treatment (Sotrovimab 500 mg IM, 500 mg IV), age (\<65, \>-65 years old), and sex (male, female) as covariates.|||3.28|-1.56|
71826240|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 1||||.88
71826241|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 2||||.35
71826242|NCT01257503|143156846|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||cold score at 7-10 day follow-up||||.36
71706664|NCT04913675|142930672|EQUIVALENCE|IM dose was assessed for equivalence to IV based on the two-sided 90% confidence interval for the treatment ratio falling within equivalence bounds of 0.5 to 2.0.|Ratio of least square(LS) geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.07|||||LS geometric mean was calculated for 500mg IV versus IM by using an Analysis of Covariance (ANCOVA) Model with treatment group (sotrovimab 500mg IM, 500mg IV), age (\<65, =\>65 years old), gender (male, female) and Baseline viral load as covariates.|||1.07|1.00|
71706665|NCT05181657|142930714|OTHER|The intervention effect was determined via a two sided, 0.05 level of significance, multivariable Poisson regression model, with Intervention group as the primary predictor.|Risk Ratio (RR)|1.45|||<|0.05|TWO_SIDED|95.0|1.18|1.78||"Alpha significance levels used:~For the primary predictor (i.e., intervention group): alpha=0.05; For covariates: alpha=0.10; For interactions: alpha=0.15"|Poisson Regression||The estimate refers to the relative risk of getting a COVID-19 test onsite (Intervention/Control). Also, the above estimate is from the unadjusted Poisson regression model (i.e., model not adjusted for covariates and interactions).|To assess whether the active intervention was more successful than the control condition at increasing COVID-19 testing, we used univariable and multivariable Poisson regression models, with whether one received onsite testing right after the intervention as the outcome and intervention group as the main predictor. Potential clustering due to the randomization by week was accounted for by specifying an exchangeable correlation structure for participants who were recruited during the same week.||1.78|1.18|<0.05
71706666|NCT01348490|142930716|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.025||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0250
71706667|NCT01348490|142930716|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.0163||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0163
71706668|NCT01348490|142930716|OTHER|1-sample t-test with null hypothesis mean \>= 0|||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
71706669|NCT01348490|142930716|OTHER|1-sample t-test with null hypothesis mean \>= 0||||||0.2019||||||1-sample t-test was used.|t-test, 1 sided|||||||0.2019
71706670|NCT01348490|142930717|OTHER|||||||0.6887||||||1-sample t-test was used.|t-test, 1 sided|||||||0.6887
71706671|NCT01348490|142930717|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
71764777|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.055||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.055
71764778|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.365||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.365
71764779|NCT00966875|143031608|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.005
71706672|NCT01348490|142930717|OTHER|||||||0.8701||||||1-sample t-test was used.|t-test, 1 sided|||||||0.8701
71706673|NCT01348490|142930721|OTHER||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided|||||||<0.0001
71706674|NCT01348490|142930722|OTHER|||||||0.0028||||||1-sample t-test was used.|t-test, 1 sided|||||||0.0028
71706675|NCT03389750|142930732|EQUIVALENCE|An F-test was used to assess for significant differences among the 13 dose conditions.||||||0.0001|||||||ANOVA|F = 7.06 (DF=12)||||||.0001
71706676|NCT01117350|142930733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.54||||0.439|TWO_SIDED|95.0|-3.88|8.93||"If superiority not demonstrated, switching from superiority to non-inferiority considered.~Conclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine - liraglutide) \> or = to - 3.5%"|Chi-squared|||"Superiority testing~H0: Rate measured with insulin glargine = rate measured with liraglutide~H1: Rate measured with insulin glargine ≠ rate measured with liraglutide~Sample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%."||8.93|-3.88|0.439
71706677|NCT01027754|142930769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Fisher Exact|||||||0.03
71706678|NCT01027754|142930770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Fisher Exact|||||||0.24
71706679|NCT01027754|142930779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71706680|NCT03280615|142930788|SUPERIORITY|||||||0.257|||||||Fisher Exact|||A Fisher exact test was performed||||0.257
71706681|NCT03280615|142930789|SUPERIORITY|||||||0.231|||||||Fisher Exact|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.231
71706682|NCT03280615|142930790|SUPERIORITY|||||||0.043|||||||Mixed Models Analysis|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups||||0.043
71706683|NCT02683954|142930791|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.||||0.05
71706684|NCT01524705|142930801|SUPERIORITY||Wilcoxon||||<|0.024||||||Wilcoxon rank sum test was used due to nonnormality distribution|Wilcoxon (Mann-Whitney)|||Two-tailed t test with type I error = 0.05, a sample of 110 participants (55 per group) would give 90% power to detect a difference of a mean change from baseline of 5 CV units (SD = 8) between control and treatment groups. An ANCOVA model, adjusting for baseline value and clinical site, was to be performed. If residual values from the ANCOVA indicated nonnormality in distribution by Shapiro-Wilk testing, a Wilcoxon rank sum test was used instead.||||<0.024
71706685|NCT01524705|142930803|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71706686|NCT01524705|142930804|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71706687|NCT01755156|142930805|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.55|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-0.34|-0.75|<0.001
71764780|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.778||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.778
71764781|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.865||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.865
71706688|NCT01755156|142930806|SUPERIORITY_OR_OTHER||Difference in %|0.5|||||TWO_SIDED|95.0|-8.8|9.8|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||9.8|-8.8|
71706689|NCT01755156|142930807|SUPERIORITY_OR_OTHER||Difference in %|-2.5|||||TWO_SIDED|95.0|-6.6|1.1|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.|||1.1|-6.6|
71764782|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.030
71764783|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.331||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.331
71764784|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.039||||||P-value is for Week 12..|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.039
71764785|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.292||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.292
71764786|NCT00966875|143031610|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.003
71764787|NCT00966875|143031612|SUPERIORITY_OR_OTHER|||||||0.09||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.090
71764788|NCT00966875|143031612|SUPERIORITY_OR_OTHER|||||||0.131||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.131
71764789|NCT00966875|143031612|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.008
71764790|NCT00966875|143031612|SUPERIORITY_OR_OTHER|||||||0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.013
71764791|NCT00966875|143031612|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
71764792|NCT00966875|143031612|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764793|NCT00966875|143031612|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764794|NCT00966875|143031614|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764795|NCT00966875|143031614|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.012
71764796|NCT00966875|143031614|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764797|NCT00966875|143031614|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71706690|NCT01755156|142930808|SUPERIORITY_OR_OTHER||Difference in %|4.5|||||TWO_SIDED|95.0|-3.3|12.3||||||||12.3|-3.3|
71706691|NCT01755156|142930809|SUPERIORITY_OR_OTHER||Difference in %|-14.5||||0.011|TWO_SIDED|95.0|-25.6|-3.4|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-3.4|-25.6|0.011
71706692|NCT01755156|142930810|SUPERIORITY_OR_OTHER||Difference in least squares means|-9.5||||0.01|TWO_SIDED|95.0|-16.7|-2.3|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-2.3|-16.7|0.010
71706693|NCT01755156|142930813|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|19.2|||<|0.001|TWO_SIDED|95.0|10.1|28.0|||Miettinen & Nurminen method|||||28.0|10.1|<0.001
71706694|NCT01755156|142930814|SUPERIORITY_OR_OTHER||Between-group rate difference (%)|4.2||||0.164|TWO_SIDED|95.0|-1.8|10.5|||Miettinen & Nurminen method|||||10.5|-1.8|0.164
71706695|NCT01755156|142930817|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.8||||0.001|TWO_SIDED|95.0|-44.8|-10.8|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||-10.8|-44.8|0.001
71764798|NCT00966875|143031614|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764799|NCT00966875|143031614|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||<0.001
71764800|NCT00966875|143031614|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.001
71764801|NCT00966875|143031616|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.013
71764802|NCT00966875|143031616|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.076
71764803|NCT00966875|143031616|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.002
71764804|NCT00966875|143031616|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||<0.001
71764805|NCT00966875|143031616|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.002
71764806|NCT00966875|143031616|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-value is for Week 12 LOCF.|Fisher Exact|||||||0.006
71764807|NCT00966875|143031616|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12.|Fisher Exact|||||||0.001
71764808|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.307||||||P-value is for Week 12.|ANCOVA|||||||0.307
71764809|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.104||||||P-value is for Week 12.|ANCOVA|||||||0.104
71764810|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.139||||||P-value is for Week 12.|ANCOVA|||||||0.139
71764811|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.056||||||P-value is for Week 12.|ANCOVA|||||||0.056
71764812|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|||||||0.048
71764813|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value is for Week 12.|ANCOVA|||||||0.160
71764814|NCT00966875|143031618|SUPERIORITY_OR_OTHER|||||||0.029||||||P-value is for Week 12.|ANCOVA|||||||0.029
71826243|NCT01090024|143156847|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.083|STANDARD_ERROR_OF_MEAN|0.624||0.4473|TWO_SIDED|95.0|-1.147|1.313|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.313|-1.147|0.4473
71826244|NCT01090024|143156847|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.67|STANDARD_ERROR_OF_MEAN|0.625||0.1426|TWO_SIDED|95.0|-0.563|1.903|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.903|-0.563|0.1426
71706696|NCT01755156|142930818|SUPERIORITY_OR_OTHER||Difference in least squares means|3.7||||0.025|TWO_SIDED|95.0|0.5|6.9|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.||||6.9|0.5|0.025
71706697|NCT01755156|142930820|SUPERIORITY_OR_OTHER||Kaplan-Meier difference %|-1.2||||0.654|TWO_SIDED|95.0|-7.0|4.7|||Log Rank|||||4.7|-7.0|0.654
71706698|NCT00090402|142930824|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0|||||Regression, Linear|Adjusted for age and body mass index||||||0.83
71706699|NCT00292370|142930853|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71706700|NCT01133977|142930883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.23|0.75||||||The current study was not powered or designed to determine superiority of the '20 mg Lenvatinib + Dacarbazine (Phase 2)' arm compared with 'Dacarbazine (Phase 2) ' arm.||0.75|0.23|
71826245|NCT01090024|143156847|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|0.281|STANDARD_ERROR_OF_MEAN|0.611||0.3231|TWO_SIDED|95.0|-0.924|1.486|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A compound symmetry covariance structure was used.||1.486|-0.924|0.3231
71826246|NCT01090024|143156848|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.056|STANDARD_ERROR_OF_MEAN|0.063||0.1879|TWO_SIDED|95.0|-0.18|0.068|||Mixed effect model||Adjusted means difference of BI 671800 200 mg BID (D) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.068|-0.180|0.1879
71826247|NCT01090024|143156848|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.026|STANDARD_ERROR_OF_MEAN|0.063||0.3384|TWO_SIDED|95.0|-0.151|0.098|||Mixed effect model||Adjusted means difference of BI 671800 400 mg PM QD (C) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.098|-0.151|0.3384
71706701|NCT03606213|142930888|OTHER|||||||0.56||||||P-value week 14 versus baseline (Cohort A, arm 1; placebo)|Wilcoxon (Mann-Whitney)|||||||0.56
71706702|NCT03074643|142930898|SUPERIORITY|||||||0.16|||||||ANCOVA|Adjusted for age, sex, race||||||0.16
71706703|NCT03074643|142930898|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
71706704|NCT03074643|142930899|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for age, sex, race||||||0.81
71706705|NCT03074643|142930899|SUPERIORITY|||||||0.8|||||||ANCOVA|Adjusted for age, sex, race||||||0.80
71706706|NCT03074643|142930900|SUPERIORITY|||||||0.56|||||||ANCOVA|Adjusted for age, sex, race||||||0.56
71706707|NCT03074643|142930900|SUPERIORITY|||||||0.96|||||||ANCOVA|Adjusted for age, sex, race||||||0.96
71706708|NCT03074643|142930901|SUPERIORITY|||||||0.76|||||||ANCOVA|Adjusted for age, sex, race||||||0.76
71706709|NCT03074643|142930901|SUPERIORITY|||||||0.45|||||||ANCOVA|Adjusted for age, sex, race||||||0.45
71706710|NCT03074643|142930902|SUPERIORITY|||||||0.75|||||||ANCOVA|Adjusted for age, sex, race||||||0.75
71706711|NCT03074643|142930902|SUPERIORITY|||||||0.95|||||||ANCOVA|Adjusted for age, sex, race||||||0.95
71706712|NCT03074643|142930903|SUPERIORITY|||||||0.06|||||||ANCOVA|Adjusted for age, sex, race||||||0.06
71706713|NCT03074643|142930903|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
71706714|NCT03074643|142930904|SUPERIORITY|||||||0.48|||||||ANCOVA|Adjusted for age, sex, race||||||0.48
71706715|NCT03074643|142930904|SUPERIORITY|||||||0.22|||||||ANCOVA|Adjusted for age, sex, race||||||0.22
71706716|NCT03615534|142930905|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.||||0.0001
71706717|NCT03615534|142930906|SUPERIORITY|||||||0.06||||||Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.||||0.060
71764815|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.272||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.272
71764816|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.962||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.962
71706718|NCT03615534|142930906|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.||||0.0001
71706719|NCT03615534|142930906|SUPERIORITY|||||||0.334||||||Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .||||0.334
71706720|NCT03615534|142930906|SUPERIORITY|||||||0.012||||||Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.||||0.012
71706721|NCT03615534|142930906|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.||||0.001
71706722|NCT03615534|142930907|SUPERIORITY|||||||0.058||||||Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.||||0.058
71706723|NCT03615534|142930907|SUPERIORITY|||||||0.067||||||Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .||||0.067
71706724|NCT03615534|142930908|SUPERIORITY|||||||0.001||||||Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.||||0.001
71706725|NCT03615534|142930909|SUPERIORITY|||||||0.786||||||Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m\^2.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.||||0.786
71706726|NCT03615534|142930910|SUPERIORITY|||||||0.0001||||||Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.||||0.0001
71706727|NCT03615534|142930911|OTHER|||||||0.201||||||Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|"Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.~."||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.||||0.201
71706728|NCT03615534|142930911|SUPERIORITY|||||||0.033||||||Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.||||0.033
71764817|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.236||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.236
71764818|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.316||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.316
71764819|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.138||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.138
71706729|NCT03615534|142930911|SUPERIORITY|||||||0.511||||||Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.||||0.511
71706730|NCT03615534|142930912|OTHER|||||||0.434||||||Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.||||0.434
71706731|NCT03615534|142930912|SUPERIORITY|||||||0.966||||||Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.||||0.966
71706732|NCT00604383|142930914|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.034
71706733|NCT01655069|142930998|OTHER||Adjusted change from baseline|-0.95|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.19|-0.71|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.71|-1.19|
71706734|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.34|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-1.34|
71706735|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.26|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.53|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-1.53|
71706736|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.39|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.63|-1.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.16|-1.63|
71706737|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.54|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-1.76|-1.32|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.32|-1.76|
71706738|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.56|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-1.81|-1.31|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.31|-1.81|
71706739|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.93|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.19|-1.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.67|-2.19|
71706740|NCT01655069|142930998|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.62|-0.23|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.23|-1.62|
71706741|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.38|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.09|-0.68|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.68|-2.09|
71706742|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.09|-0.7|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.70|-2.09|
71764820|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.975||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.975
71706743|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.58|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.27|-0.88|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.88|-2.27|
71706744|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.8|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.5|-1.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.10|-2.50|
71706745|NCT01655069|142930998|OTHER||Adjusted change from baseline|-1.57|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.29|-0.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.85|-2.29|
71706746|NCT01655069|142930998|OTHER||Adjusted change from baseline|-2.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.83|-1.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.17|-2.83|
71706747|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.35|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.97|1.73|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.73|0.97|
71706748|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.43|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.02|1.83|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||1.83|1.02|
71706749|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.72|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.27|2.16|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.16|1.27|
71706750|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.8|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|1.36|2.24|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.24|1.36|
71706751|NCT01655069|142930999|OTHER||Adjusted change from baseline|2.21|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|1.74|2.67|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.67|1.74|
71706752|NCT01655069|142930999|OTHER||Adjusted change from baseline|2.28|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|1.79|2.77|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.77|1.79|
71706753|NCT01655069|142930999|OTHER||Adjusted change from baseline|2.84|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|2.19|3.49|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.49|2.19|
71706754|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.53|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.17|2.89|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||2.89|0.17|
71706755|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.9|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|0.52|3.27|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.27|0.52|
71764821|NCT00966875|143031620|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.079
71764822|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.982||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.982
71706756|NCT01655069|142930999|OTHER||Adjusted change from baseline|1.75|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.39|3.1|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.10|0.39|
71706757|NCT01655069|142930999|OTHER||Adjusted change from baseline|2.69|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.34|4.05|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.05|1.34|
71706758|NCT01655069|142930999|OTHER||Adjusted change from baseline|3.07|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|1.7|4.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||4.43|1.70|
71826248|NCT01090024|143156848|SUPERIORITY|One-sided p-value testing superiority of BI 671800 vs placebo with 2.5% alpha.|Adjusted means difference|-0.093|STANDARD_ERROR_OF_MEAN|0.062||0.067|TWO_SIDED|95.0|-0.214|0.029|||Mixed effect model||Adjusted means difference of BI 671800 400 mg AM QD (B) vs Placebo (A).|Restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM) with terms for baseline, treatment and period as fixed effects and patient as a random effect was used. A autoregressive covariance structure was used.||0.029|-0.214|0.0670
71826249|NCT00516503|143156864|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
71706759|NCT01655069|142930999|OTHER||Adjusted change from baseline|2.45|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|1.05|3.85|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||3.85|1.05|
71706760|NCT01655069|142930999|OTHER||Adjusted change from baseline|3.93|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|2.34|5.53|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||5.53|2.34|
71706761|NCT01655069|142931000|OTHER||Adjusted change from baseline|-0.98|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.27|-0.69|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.69|-1.27|
71706762|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.44|-0.86|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.86|-1.44|
71706763|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.31|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.6|-1.02|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-1.02|-1.60|
71706764|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.22|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.51|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.93|-1.51|
71826250|NCT00516503|143156865|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
71706765|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.5|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-1.8|-1.21|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.21|-1.80|
71764823|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.276||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.276
71764824|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.050
71826251|NCT00516503|143156866|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
71826252|NCT02987543|143156871|SUPERIORITY||Odds Ratio (OR)|20.86|||<|0.0001|TWO_SIDED|95.0|4.18|379.18|||Regression, Logistic|||||379.18|4.18|<0.0001
71826253|NCT02987543|143156872|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.38|0.63|||Regression, Cox|||||0.63|0.38|<0.0001
71826254|NCT02987543|143156873|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0192|TWO_SIDED|95.0|0.22|0.91|||Regression, Cox|||||0.91|0.22|0.0192
71706766|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.52|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-1.83|-1.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.22|-1.83|
71706767|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.83|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-2.22|-1.43|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.43|-2.22|
71706768|NCT01655069|142931000|OTHER||Adjusted change from baseline|-0.93|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.73|-0.13|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.13|-1.73|
71706769|NCT01655069|142931000|OTHER||Adjusted change from baseline|-0.94|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.48|-0.4|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.40|-1.48|
71706770|NCT01655069|142931000|OTHER||Adjusted change from baseline|-0.81|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.46|-0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.17|-1.46|
71706771|NCT01655069|142931000|OTHER||Adjusted change from baseline|-0.91|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.53|-0.28|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.28|-1.53|
71706772|NCT01655069|142931000|OTHER||Adjusted change from baseline|-0.71|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.8|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-1.80|
71706773|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.18|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.92|-0.44|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.44|-1.92|
71706774|NCT01655069|142931000|OTHER||Adjusted change from baseline|-1.79|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.59|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.59|
71706775|NCT01655069|142931001|OTHER||Adjusted change from baseline|-0.74|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.65|0.17|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 3 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||0.17|-1.65|
71706776|NCT01655069|142931001|OTHER||Adjusted change from baseline|-1.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.23|-0.36|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 6 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.36|-2.23|
71706777|NCT01655069|142931001|OTHER||Adjusted change from baseline|-1.14|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.06|-0.22|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 9 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.22|-2.06|
71706778|NCT01655069|142931001|OTHER||Adjusted change from baseline|-1.28|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.18|-0.38|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 12 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.38|-2.18|
71706779|NCT01655069|142931001|OTHER||Adjusted change from baseline|-1.04|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.95|-0.12|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 24 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"||-0.12|-1.95|
71764825|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.010
71654209|NCT00904748|142825421|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.23|||||TWO_SIDED|90.0|90.67|104.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.26|90.67|
71654210|NCT00904748|142825422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|80.83|||||TWO_SIDED|90.0|72.38|90.26|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||90.26|72.38|
71706780|NCT01655069|142931001|OTHER||Adjusted change from baseline|-1.96|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.93|-1.0|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 40 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-1.00|-2.93|
71706781|NCT01655069|142931001|OTHER||Adjusted change from baseline|-2.2|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.48|-0.93|||Repeated Measures ANCOVA|Duration of solifenacin treatment: 52 weeks||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."||-0.93|-3.48|
71826255|NCT02987543|143156874|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0175|TWO_SIDED|95.0|0.5|0.97||2-sided p-value|Regression, Cox|||||0.97|0.50|0.0175
71706782|NCT06399471|142931003|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.126||||||One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.|ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.126
71706783|NCT06399471|142931003|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.015|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Ten Meter Walking Test.||||0.015
71706784|NCT06399471|142931003|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.852|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Ten Meter Walking Test.||||0.852
71706785|NCT06399471|142931004|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.003|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.003
71706786|NCT06399471|142931004|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.027|||||||ANOVA|||An ANOVA was used to compare the Power Knee and the Rheo when used during Two Meter Walking Test.||||0.027
71706787|NCT06399471|142931004|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.425|||||||ANOVA|||An ANOVA was used to compare the Rheo and the C-Leg 4.0 when used during Two Meter Walking Test.||||0.425
71706788|NCT06399471|142931005|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.006|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the C-Leg 4.0.||||0.006
71654211|NCT00904748|142825422|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|78.76|||||TWO_SIDED|90.0|70.53|87.96|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||87.96|70.53|
71654212|NCT00904748|142825423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|99.12|||||TWO_SIDED|90.0|92.76|105.93|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||105.93|92.76|
71654213|NCT00904748|142825423|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.84|||||TWO_SIDED|90.0|91.56|104.56|||ANOVA||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||104.56|91.56|
71654214|NCT00904748|142825424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|90.0|-0.14|0.5|||ANOVA|||Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).||0.50|-0.14|
71706789|NCT06399471|142931005|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.236|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Power Knee and the Rheo.||||0.236
71706790|NCT06399471|142931005|OTHER|Non-parametric Friedman's test with multiple comparison correction||||||0.118|||||||Non-parametric Friedman's test with mult|||The Non-parametric Friedman's test was used to compare the survey results between the participants using the Rheo and the C-Leg 4.0.||||0.118
71706791|NCT06399471|142931006|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.687|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and the Rheo when used during Stance Time Asymmetry Index test.||||0.687
71706792|NCT06399471|142931007|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.082|||||||ANOVA|||An ANOVA was used to compare the Power Knee, the C-Leg 4.0, and Rheo when used during the Narrowing beam walking test.||||0.082
71706793|NCT06399471|142931008|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.943|||||||ANOVA|||An ANOVA was used to compare the reported falls when for when the Power Knee, C-Leg 4.0, and the Rheo were used.||||0.943
71706794|NCT06399471|142931009|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.535|||||||ANOVA|||An ANOVA was used to compare the Physiological cost index for when the Power Knee, the C-Leg 4.0, and the Rheo were used.||||0.535
71826256|NCT02987543|143156875|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|||||0.47|0.25|<0.0001
71826257|NCT01451814|143156883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|95.0|0.67|5.48|||Chi-squared|||||5.48|0.67|.22
71706795|NCT06399471|142931010|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.229|||||||ANOVA|||An ANOVA was used to compare the Stair Ascent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.229
71764826|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.046||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.046
71654215|NCT00904748|142825424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|90.0|-0.27|0.28|||ANOVA|||Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).||0.28|-0.27|
71654216|NCT00700817|142825434|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6||||0.0001||95.0|-0.77|-0.43||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.||-0.43|-0.77|0.0001
71654217|NCT00700817|142825434|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.34||||0.0001||95.0|-0.51|-0.16||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.||-0.16|-0.51|0.0001
71654218|NCT00700817|142825435|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.63||||0.0001||95.0|-0.81|-0.44||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.8 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.44|-0.81|0.0001
71654219|NCT00700817|142825435|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.4||||0.0001||95.0|-0.59|-0.22||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.2 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.||-0.22|-0.59|0.0001
71654220|NCT00700817|142825437|SUPERIORITY_OR_OTHER||Change within treatment group|-0.24|STANDARD_DEVIATION|0.7||0.006||95.0|-0.41|-0.07||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.07|-0.41|0.0060
71654221|NCT00700817|142825437|SUPERIORITY_OR_OTHER||Change within treatment group|-0.45|STANDARD_DEVIATION|0.9||0.0001||95.0|-0.67|-0.23||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.||-0.23|-0.67|0.0001
71654222|NCT04070287|142825509|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654223|NCT04070287|142825510|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654224|NCT04070287|142825511|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654225|NCT04070287|142825512|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654226|NCT04070287|142825513|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654227|NCT04070287|142825514|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654228|NCT00767520|142825516|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.148|||||||Un-stratified log-rank test|||||||0.148
71654229|NCT00606502|142825536|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.61|1.14||||||||1.14|0.61|
71654230|NCT00279955|142825576|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.07|STANDARD_DEVIATION|0.292||0.0119|TWO_SIDED|95.0|1.17|3.67|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.|||3.67|1.17|0.0119
71654231|NCT00279955|142825577|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.9|STANDARD_DEVIATION|0.277||0.0185|TWO_SIDED|95.0|1.11|3.27|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing \<90% in last 21 days of DREP.|||3.27|1.11|0.0185
71654232|NCT00279955|142825578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|STANDARD_DEVIATION|0.311||0.0578|TWO_SIDED|95.0|0.98|3.31|||Regression, Cox||A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.|||3.31|0.98|0.0578
71654233|NCT03438227|142825581|SUPERIORITY|||||||0.039|||||||Chi-squared|||||||0.039
71654234|NCT03438227|142825582|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
71654235|NCT03438227|142825583|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
71654236|NCT03438227|142825584|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
71654237|NCT03438227|142825585|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
71654238|NCT03438227|142825586|SUPERIORITY|||||||0.194|||||||Fisher Exact|||||||0.194
71654239|NCT03438227|142825587|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
71654240|NCT03438227|142825588|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71654241|NCT03438227|142825589|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||0.571
71654242|NCT03438227|142825590|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
71654243|NCT03438227|142825591|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
71654244|NCT03438227|142825592|SUPERIORITY|||||||0.933|||||||t-test, 2 sided|||||||0.933
71764827|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.017
71764828|NCT00966875|143031622|SUPERIORITY_OR_OTHER|||||||0.066||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.||||||0.066
71654245|NCT03438227|142825593|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
71654246|NCT03438227|142825594|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
71654247|NCT02516410|142825688|SUPERIORITY||Least squares (LS) mean difference|1.2|||=|0.1176|TWO_SIDED|95.0|-0.3|2.6|||Mixed-effect repeated measure (MMRM)|||||2.6|-0.3|= 0.1176
71654248|NCT03861481|142825718|SUPERIORITY||LS Mean difference (Rozimab - Placebo)|-0.052|||||TWO_SIDED|90.0|-0.892|0.788|||||MMRM analysis (fixed effect terms: treatment, baseline iRODS score, prior Ig therapy administration route, assessment week, treatment by week interaction; random effect term: study participant). LS Mean Difference \> 0 favours rozanolixizumab.|||0.788|-0.892|
71654249|NCT00773734|142825719|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.6||||0.1846|TWO_SIDED|95.0|-2.6|13.7|||Chi-squared|||||13.7|-2.6|0.1846
71654250|NCT00773734|142825719|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7|||Chi-squared|||||33.7|12.4|<0.0001
71654251|NCT00773734|142825719|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|23.9|46.6|||Chi-squared|||||46.6|23.9|<0.0001
71654252|NCT00773734|142825721|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.2||||0.059|TWO_SIDED|95.0|-0.4|26.8|||Chi-squared|||||26.8|-0.4|0.0590
71654253|NCT00773734|142825721|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|22.1||||0.0023|TWO_SIDED|95.0|8.3|36.0|||Chi-squared|||||36.0|8.3|0.0023
71654254|NCT00773734|142825721|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.2|||<|0.0001|TWO_SIDED|95.0|21.6|48.9|||Chi-squared|||||48.9|21.6|<0.0001
71654255|NCT00773734|142825723|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.4||||0.1776|TWO_SIDED|95.0|-1.5|8.2|||Chi-squared|||||8.2|-1.5|0.1776
71654256|NCT00773734|142825723|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.1||||0.0158|TWO_SIDED|95.0|1.6|14.5|||Chi-squared|||||14.5|1.6|0.0158
71654257|NCT00773734|142825723|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.2||||0.0051|TWO_SIDED|95.0|3.2|17.2|||Chi-squared|||||17.2|3.2|0.0051
71654258|NCT00773734|142825728|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-13.7||||0.0156|TWO_SIDED|95.0|-24.8|-2.6|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.6|-24.8|0.0156
71654259|NCT00773734|142825728|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.4|-13.9|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-13.9|-36.4|<0.0001
71654260|NCT00773734|142825728|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-44.0|-21.7|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-21.7|-44.0|<0.0001
71654261|NCT00773734|142825730|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||0.6541|TWO_SIDED|95.0|-11.7|7.3|||Chi-squared|||||7.3|-11.7|0.6541
71654262|NCT00773734|142825730|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.4||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Chi-squared|||||24.1|0.6|0.0402
71654263|NCT00773734|142825730|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.1||||0.0011|TWO_SIDED|95.0|8.8|33.4|||Chi-squared|||||33.4|8.8|0.0011
71654264|NCT00773734|142825734|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.2||||0.002|TWO_SIDED|95.0|-33.0|-7.5|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-7.5|-33.0|0.0020
71654265|NCT00773734|142825734|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-42.9|-17.0|||ANCOVA|based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate||||-17.0|-42.9|<0.0001
71654266|NCT00773734|142825734|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-42.4|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.5||Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|ANCOVA|||||-29.5|-55.2|<0.0001
71654267|NCT00773734|142825736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.1322|TWO_SIDED|95.0|-3.1|0.4|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||0.4|-3.1|0.1322
71654268|NCT00773734|142825736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.9|-2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-2.3|-5.9|<0.0001
71654269|NCT00773734|142825736|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.6||||0.0047|TWO_SIDED|95.0|-4.3|-0.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||-0.8|-4.3|0.0047
71654270|NCT00773734|142825738|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.3||||0.0078|TWO_SIDED|95.0|0.9|5.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||5.8|0.9|0.0078
71654271|NCT00773734|142825738|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.5||||0.0068|TWO_SIDED|95.0|1.0|6.0|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.0|1.0|0.0068
71654272|NCT00773734|142825738|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|3.6||||0.0045|TWO_SIDED|95.0|1.1|6.1|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||6.1|1.1|0.0045
71654273|NCT00773734|142825739|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6097|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.8|-1.6|0.6097
71764829|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.538||||||P-value is for Week 12.|Fisher Exact|||||||0.538
71764830|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.515||||||P-value is for Week 12.|Fisher Exact|||||||0.515
71764831|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value is for Week 12.|Fisher Exact|||||||0.030
71764832|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for Week 12.|Fisher Exact|||||||0.053
71764833|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.393||||||P-value is for Week 12.|Fisher Exact|||||||0.393
71764834|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.077||||||P-value is for Week 12.|Fisher Exact|||||||0.077
71706796|NCT06399471|142931011|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.528|||||||ANOVA|||An ANOVA was used to compare the Stair Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.528
71706797|NCT06399471|142931012|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.144|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the C-Leg 4.0.||||0.144
71706798|NCT06399471|142931012|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.024|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Power Knee and the Rheo.||||0.024
71706799|NCT06399471|142931012|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary.||||||0.949|||||||ANOVA|||An ANOVA was used to compare the Ramp Ascent Speed between the Rheo and the C-Leg 4.0.||||0.949
71706800|NCT06399471|142931013|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.051|||||||ANOVA|||An ANOVA was used to compare the Ramp Descent Speed for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.051
71706801|NCT06399471|142931014|OTHER|One-way Repeated Measures ANOVA with sphericity correction (Huynh-Feldt) applied if necessary||||||0.367|||||||ANOVA|||An ANOVA was used to compare the Steps per Day for the Power Knee, C-Leg 4.0, and the Rheo when used.||||0.367
71706802|NCT00601107|142931024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||1|TWO_SIDED|95.0|0.17|4.22||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.22|0.17|1.000
71706803|NCT00601107|142931024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.992||95.0|0.13|4.14||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.14|0.13|0.992
71764835|NCT00966875|143031624|SUPERIORITY_OR_OTHER|||||||0.105||||||P-value is for Week 12.|Fisher Exact|||||||0.105
71764836|NCT02386189|143031642|SUPERIORITY||Mean Difference (Net)|-4.65|STANDARD_DEVIATION|7.3||0.02|TWO_SIDED||||||t-test, 2 sided|||The t-test was conducted on change between baseline and 12-month follow-up.||||0.02
71764837|NCT02386189|143031643|SUPERIORITY||Mean Difference (Net)|2.91|STANDARD_DEVIATION|5.5||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
71764838|NCT02386189|143031644|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.7||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.71
71706804|NCT00601107|142931024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||1|TWO_SIDED|95.0|0.15|4.59||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (\<=16, \>16).||4.59|0.15|1.000
71706805|NCT00147537|142931031|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||binomial test|||A one-sided p-value for H0: objective response rate \<=0.28 using exact binomial test at level 0.05.||||=0.027
71706806|NCT00147537|142931032|SUPERIORITY_OR_OTHER||||||=|0.121|TWO_SIDED||||||binomial test|||A One-sided p-value for H0: objective response rate \<=0.30 using exact binomial test at level 0.05.||||=0.121
71706807|NCT02006654|142931069|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.46||0.2365|TWO_SIDED|95.0|-1.45|0.36||Corrected for multiplicity|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for idalopirdine at significance level 5%.||0.36|-1.45|0.2365
71764839|NCT02386189|143031645|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71764840|NCT02386189|143031646|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|0.15||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
71764841|NCT02386189|143031647|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_DEVIATION|7.1||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
71764842|NCT02386189|143031648|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|8.9||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
71764843|NCT04657666|143031649|SUPERIORITY||Combined least mean square difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7152|TWO_SIDED|95.0|-0.16|0.23||Based on a combination of 300 linear mixed models for crossover data on the response variable change from baseline in LLMT-6 with period level LLMT-6 baseline covariate, treatment group, period, and sequence as fixed effects.|Mixed Models Analysis|Pattern mixture model (PMM) control-based imputation, mixed model repeated measures (MMRM)||||0.23|-0.16|0.7152
71764844|NCT02250703|143031699|SUPERIORITY_OR_OTHER|||||||0.025||||||Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)|Chi-squared|||A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power||||0.025
71764845|NCT02250703|143031700|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71764846|NCT02250703|143031701|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71764847|NCT02250703|143031702|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71764848|NCT03232333|143031762|SUPERIORITY||||||=|0.71|||||||t-test, 1 sided|||||||=0.71
71764849|NCT03232333|143031763|SUPERIORITY||||||=|0.63|||||||t-test, 1 sided|||||||=0.63
71764850|NCT03232333|143031764|SUPERIORITY||||||=|0.01|||||||t-test, 1 sided|||||||=.01
71764851|NCT00653432|143031769|SUPERIORITY|||||||0.145|||||||Ordinal GEE Model|||||||0.1450
71764852|NCT00653432|143031770|SUPERIORITY|||||||0.5824|||||||Ordinal GEE Model|||||||0.5824
71764853|NCT00653432|143031771|SUPERIORITY|||||||0.9136|||||||Ordinal GEE Model|||||||0.9136
71706808|NCT02006654|142931070|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4064|TWO_SIDED|95.0|-0.09|0.23||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||0.23|-0.09|0.4064
71706809|NCT02006654|142931071|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.63||0.4064|TWO_SIDED|95.0|-0.57|1.92||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.||1.92|-0.57|0.4064
71706810|NCT01933425|142931084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.05|TWO_SIDED|95.0|0.07|0.59|||t-test, 2 sided|||||0.59|0.07|<0.05
71706811|NCT01933425|142931085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|||<|0.05|TWO_SIDED|95.0|0.06|0.54|||t-test, 2 sided|||||0.54|0.06|<0.05
71764854|NCT00653432|143031772|SUPERIORITY|||||||0.1699|||||||Ordinal GEE Model|||||||0.1699
71764855|NCT00653432|143031773|SUPERIORITY|||||||0.3238|||||||Ordinal GEE Model|||||||0.3238
71764856|NCT00653432|143031774|SUPERIORITY|||||||0.0427|||||||Ordinal GEE Model|||||||0.0427
71764857|NCT00653432|143031775|SUPERIORITY|||||||0.8206|||||||Ordinal GEE Model|||||||0.8206
71764858|NCT00653432|143031776|SUPERIORITY|||||||0.9818|||||||Ordinal GEE Model|||||||0.9818
71764859|NCT00653432|143031777|SUPERIORITY|||||||0.0542|||||||Ordinal GEE Model|||||||0.0542
71764860|NCT00653432|143031778|SUPERIORITY|||||||0.323|||||||Ordinal GEE Model|||||||0.3230
71826258|NCT01451814|143156884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3||||0.06|TWO_SIDED|95.0|0.84|22.1|||Chi-squared|||||22.1|0.84|.06
71826259|NCT01451814|143156885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||0.18|TWO_SIDED|95.0|0.56|16.11|||Chi-squared|||||16.11|0.56|.18
71826260|NCT01280591|143156889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.3|STANDARD_ERROR_OF_MEAN|13.17||0.0002|TWO_SIDED|95.0|-106.8|-33.7|||ANCOVA|||||-33.7|-106.8|0.0002
71826261|NCT01280591|143156890|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71826262|NCT01280591|143156891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|70.4|STANDARD_ERROR_OF_MEAN|12.85||0.0001|TWO_SIDED|95.0|28.1|112.7|||ANCOVA|||||112.7|28.1|0.0001
71826263|NCT01280591|143156892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|2.14||0.0007|TWO_SIDED|95.0|3.7|19.7|||ANCOVA|||||19.7|3.7|0.0007
71826264|NCT01280591|143156893|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71826265|NCT01280591|143156894|SUPERIORITY_OR_OTHER|||||||0.0027|||||||Cochran-Mantel-Haenszel|||||||0.0027
71826266|NCT01280591|143156895|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Cochran-Mantel-Haenszel|||||||0.0321
71826267|NCT01280591|143156896|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
71826268|NCT01280591|143156897|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71826269|NCT01280591|143156898|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
71826270|NCT01280591|143156899|SUPERIORITY_OR_OTHER|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
71826271|NCT01280591|143156900|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71826272|NCT01280591|143156901|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71826273|NCT01280591|143156902|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Cochran-Mantel-Haenszel|||||||0.0016
71826274|NCT01280591|143156903|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
71826275|NCT01280591|143156904|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71826276|NCT01280591|143156905|SUPERIORITY_OR_OTHER|||||||0.0064|||||||ANCOVA|||||||0.0064
71826277|NCT01280591|143156906|SUPERIORITY_OR_OTHER|||||||0.0047|||||||Cochran-Mantel-Haenszel|||||||0.0047
71826278|NCT01280591|143156907|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Log Rank|||||||0.0053
71826279|NCT01280591|143156909|SUPERIORITY_OR_OTHER|||||||0.2734|||||||Cochran-Mantel-Haenszel|||||||0.2734
71826280|NCT02131324|143156964|EQUIVALENCE|Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||||0.086|||||||ANOVA|||Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||0.086
71826281|NCT00420316|143156971|SUPERIORITY_OR_OTHER||Percent reduction|34.3||||0.691|TWO_SIDED|95.0|-348.7|88.9|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||88.9|-348.7|0.691
71826282|NCT00420316|143156972|SUPERIORITY_OR_OTHER||Percent reduction|50.7||||0.551|TWO_SIDED|95.0|-3769.6|99.4|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who have received placebo.||99.4|-3769.6|0.551
71654274|NCT00773734|142825739|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.3||||0.2424|TWO_SIDED|95.0|-0.9|3.6|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||3.6|-0.9|0.2424
71654275|NCT00773734|142825739|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.9528|TWO_SIDED|95.0|-2.2|2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.||||2.3|-2.2|0.9528
71654276|NCT01287039|142825844|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.501|||<|0.0001|TWO_SIDED|95.0|0.3726|0.6737||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6737|0.3726|<0.0001
71654277|NCT01287039|142825845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.0311|<|0.0001|TWO_SIDED|95.0|0.076|0.198|||Mixed Model Repeated Measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.198|0.076|<0.0001
71654278|NCT01287039|142825846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.0967||0.0143|TWO_SIDED|95.0|0.048|0.428|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.428|0.048|0.0143
71654279|NCT01287039|142825847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.0681||0.0001|TWO_SIDED|95.0|-0.399|-0.132|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||-0.132|-0.399|0.0001
71654280|NCT01287039|142825848|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.575|||<|0.0001|TWO_SIDED|95.0|0.44|0.75|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.750|0.440|<0.0001
71654281|NCT01287039|142825849|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.0125|<|0.0001|TWO_SIDED|95.0|0.034|0.083|||Mixed model repeated measures|||For each week, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.083|0.034|<0.0001
71654282|NCT01287039|142825850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.1632||0.0919|TWO_SIDED|95.0|-0.597|0.045|||Mixed model repeated measures|||Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, OCS use at enrollment as fixed factors, and covariate for baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.||0.045|-0.597|0.0919
71654283|NCT01287039|142825851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.0244|<|0.0001|TWO_SIDED|95.0|-0.514|-0.418|||Mixed model repeated measures|||"Eosinophil Count Over 16 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.418|-0.514|<0.0001
71654284|NCT01287039|142825851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.455|STANDARD_ERROR_OF_MEAN|0.0182|<|0.0001|TWO_SIDED|95.0|-0.491|-0.419|||Mixed model repeated measures|||"Eosinophil Count Over 52 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."||-0.419|-0.491|<0.0001
71706812|NCT00676689|142931087|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.971|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.889|0.993||||||||0.993|0.889|
71706813|NCT00676689|142931088|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|0.941|STANDARD_ERROR_OF_MEAN|0.028|||TWO_SIDED|95.0|0.851|0.978||||||Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.||0.978|0.851|
71706814|NCT00676689|142931089|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.9|||||TWO_SIDED|||||||||Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.||||
71706815|NCT00563316|142931099|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.894|1.074|||||Ratio of Cycle 2 : Cycle 1|||1.074|0.894|
71706816|NCT00563316|142931100|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.898|||||TWO_SIDED|90.0|0.819|0.985|||||Ratio of Cycle 2 : Cycle 1|||0.985|0.819|
71886561|NCT05227690|143293408|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.572|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.5720
71886562|NCT05227690|143293408|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.7459|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.7459
71886563|NCT05227690|143293408|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06|=|0.6729|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6729
71706817|NCT00563316|142931101|NON_INFERIORITY_OR_EQUIVALENCE|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.897|||||TWO_SIDED|90.0|0.818|0.983|||||Ratio of Cycle 2 : Cycle 1|||0.983|0.818|
71706818|NCT00063232|142931169|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||paired t-test|||"self-controlled comparison of NASH activity index at 48 weeks and baseline. Null hypothesis is no change."||||<0.001
71706819|NCT00063232|142931170|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||self-controlled comparison of serum aminotransferase levels at 48 weeks and baseline. Null hypothesis: No change||||0.04
71706820|NCT00063232|142931171|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||paired t-test|||||||0.04
71706821|NCT03339453|142931172|NON_INFERIORITY|95% Confidence Interval of the treatment differences in treatment success rate.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.52|1.52||||||||1.52|-1.52|
71706822|NCT02151604|142931199|OTHER||Pearson's coefficient|-0.57||||0.041|TWO_SIDED||||||Pearson's correlation analysis|||Correlation with field of irradiation||||0.041
71706823|NCT02151604|142931201|OTHER||Pearson's coefficient|0.6||||0.037|TWO_SIDED|||||Pearson's correlation coefficient: 0.60|Pearson's Correlation Analysis|0.60||Correlation of change in ventilation signal with that of alveolar volume (VA)||||0.037
71706824|NCT02151604|142931201|OTHER||Pearson's correlation coefficient|0.7||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient: 0.70||Correlation of change in ventilation signal with that of diffusing capacity for carbon monoxide(TLCO)||||0.012
71706825|NCT02151604|142931201|OTHER||Pearson's correlation coefficient|-0.85||||0.032|TWO_SIDED||||||Pearson's correlation analysis|R = -0.85||Correlation of change in ventilation signal with that of residual volume (RV)||||0.032
71706826|NCT02151604|142931201|OTHER||Pearson's correlation coefficient|-0.95||||0.004|TWO_SIDED||||||Pearson's correlation analysis|R = -0.95||Correlation of change in ventilation signal with that of functional residual capacity (FRC)||||0.004
71706827|NCT02151604|142931201|OTHER||Pearson's correlation coefficient|-0.88||||0.012|TWO_SIDED||||||Pearson's correlation analysis|Pearson's correlation coefficient = -0.88||Correlation of change in ventilation signal with that of inspiratory capacity(IC)||||0.012
71706828|NCT00944645|142931216|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis I: The Cmax of nicotinuric acid (NUA) following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of NUA Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.98||||||90.0|0.93|1.03||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.03|0.93|
71706829|NCT00944645|142931217|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis II: The total urinary excretion of niacin and niacin metabolites following the administration of MK0524 (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of total urinary excretion of niacin and its metabolites is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.94||||||90.0|0.89|0.98||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||0.98|0.89|
71706830|NCT00944645|142931218|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis III: The AUC0-infinity of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 AUC0-∞ is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.0||||||95.0|0.95|1.05||||||"Group B: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~Group A: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.05|0.95|
71706831|NCT00944645|142931219|NON_INFERIORITY_OR_EQUIVALENCE|Primary research hypothesis IV: The Cmax of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.02||||||95.0|0.96|1.09||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"||1.09|0.96|
71738982|NCT00620113|142990731|SUPERIORITY_OR_OTHER||Difference in LS Means|1.86||||0.003|TWO_SIDED|95.0|0.64|3.08||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.08|0.64|0.003
71826283|NCT00420316|143156974|SUPERIORITY_OR_OTHER||Percent reduction|100.0||||0.33|TWO_SIDED|95.0|-1822.5|100.0|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||100|-1822.5|0.33
71654285|NCT01287039|142825853|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4499|||<|0.0001|TWO_SIDED|95.0|0.3255|0.622||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.6220|0.3255|<0.0001
71706832|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED|95.0|0.18|0.91||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.91|0.18|<.01
71706833|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|-0.35|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.37|-0.35|.96
71706834|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.18|<|0.01|TWO_SIDED|95.0|-0.89|-0.18||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.18|-0.89|<.01
71706835|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.09|0.38||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.38|-0.09|.23
71706836|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9|TWO_SIDED|95.0|-0.25|0.22||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.22|-0.25|.90
71706837|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.38|0.07||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.07|-0.38|.17
71826284|NCT00420316|143156975|SUPERIORITY_OR_OTHER||Percent reduction|-97.2||||1|TWO_SIDED|95.0|-9610.8|80.5|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||80.5|-9610.8|1
71706838|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|95.0|-0.16|0.28||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.28|-0.16|.58
71706839|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.15|TWO_SIDED|95.0|-0.06|0.37||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.37|-0.06|.15
71706840|NCT03537729|142931220|SUPERIORITY|Power was based on planned 12 sites and effect size Cohen's d=0.42 for pairwise differences between arms, intraclass correlation coefficient of 0.0012, and reduction in variance due to adjustment for baseline and repeated measures with correlation of 0.4 between pairs of measures. The sample size requirement was 38 per group, or 114 total for power of .80 in two-sided tests at .05 level of significance.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.11|0.29||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.29|-0.11|.37
71706841|NCT03537729|142931221|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.04|TWO_SIDED|95.0|-0.07|-0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Cues minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||-0.01|-0.07|.04
71706842|NCT03537729|142931221|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1|TWO_SIDED|95.0|-0.07|0.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus control.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.01|-0.07|.10
71706843|NCT03537729|142931221|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED|95.0|-0.03|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.||0.04|-0.03|.69
71706844|NCT03537729|142931222|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.65||||0.04|TWO_SIDED|95.0|0.44|0.99||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means for two arms was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.99|0.44|0.04
71706845|NCT03537729|142931222|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.59||||0.01|TWO_SIDED|95.0|0.39|0.9||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||0.90|0.39|.01
71826285|NCT00420316|143156976|SUPERIORITY_OR_OTHER||Percent reduction|0.0||||1|TWO_SIDED|95.0|0.0|98.7|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||98.7|0|1
71826286|NCT00420316|143156977|SUPERIORITY_OR_OTHER||Percent reduction|-23.2||||0.817|TWO_SIDED|95.0|-287.7|54.8|||Fisher Exact|||Vaccine efficacy with respect to severe gastroenteritis (GE) was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.||54.8|-287.7|0.817
71706846|NCT03537729|142931222|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.9||||0.61|TWO_SIDED|95.0|0.6|1.35||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.||1.35|0.60|.61
71706847|NCT03537729|142931222|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|1.26||||0.26|TWO_SIDED|95.0|0.84|1.88||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for cues divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.88|0.84|.26
71706848|NCT03537729|142931222|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.79||||0.25|TWO_SIDED|95.0|0.53|1.19||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for control. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||1.19|0.53|.25
71706849|NCT03537729|142931222|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Ratio of mean proportions of errors|0.63||||0.03|TWO_SIDED|95.0|0.42|0.94||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Generalized mixed model analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline, and use of wheelchair on the route.|Ratio of mean proportion of errors for spaced retrieval divided by proportion of errors for cues. Log of the mean was estimated from generalized linear mixed effects models for each arm. The difference between logs of means was exponentiated.|The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.||0.94|0.42|.03
71706850|NCT03537729|142931223|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.69||0.31|TWO_SIDED|95.0|-5.03|1.6||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Cues minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||1.60|-5.03|.31
71706851|NCT03537729|142931223|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.75||0.66|TWO_SIDED|95.0|-4.23|2.66||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus control.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||2.66|-4.23|.66
71706852|NCT03537729|142931223|SUPERIORITY|Sample size was determined by power analysis for the adjusted wayfinding speed.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.65||0.57|TWO_SIDED|95.0|-2.3|4.17||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Covariates included baseline value of the outcome, age, sex, and cognition score at baseline.|Spaced retrieval minus cues only.|The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.||4.17|-2.30|.57
71706853|NCT01654250|142931237|SUPERIORITY_OR_OTHER||Least Square(LS) Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-10.9|-3.1|||Mixed Models Analysis|||Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.1|-10.9|<0.001
71706854|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.7|-3.7|||Mixed Models Analysis|||Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-3.7|-12.7|<0.001
71826287|NCT05419557|143157007|SUPERIORITY||Odds Ratio (OR)|8.5||||0.02|TWO_SIDED|95.0|1.3|54.6|||Regression, Logistic|||||54.6|1.3|0.02
71826288|NCT05419557|143157008|SUPERIORITY||Odds Ratio (OR)|9.98||||0.015|TWO_SIDED|95.0|1.55|64.25|||Regression, Logistic|||||64.25|1.55|0.015
71826289|NCT00920686|143157014|SUPERIORITY_OR_OTHER|||||||0.6407|||||||Log Rank|||||||0.6407
71826290|NCT04304534|143157031|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.052|||=|0.8439|TWO_SIDED|90.0|0.687|1.612|||Log Rank|||Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group||1.612|0.687|= 0.8439
71826291|NCT04304534|143157031|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.096|||=|0.7562|TWO_SIDED|90.0|0.674|1.781|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.781|0.674|= 0.7562
71826292|NCT04304534|143157031|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.008|||=|0.978|TWO_SIDED|90.0|0.614|1.656|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.656|0.614|= 0.978
71706855|NCT01654250|142931238|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
71706856|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-17.3|-8.3|||Mixed Models Analysis|||Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-8.3|-17.3|<0.001
71706857|NCT01654250|142931238|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
71706858|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-16.8|-7.8|||Mixed Models Analysis|||Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-7.8|-16.8|<0.001
71706859|NCT01654250|142931238|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
71706860|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-12.3|-3.3|||Mixed Models Analysis|||Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.||-3.3|-12.3|<0.001
71706861|NCT01654250|142931238|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||<0.001
71706862|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.28||0.133|TWO_SIDED|95.0|-7.9|1.1|||Mixed Models Analysis|||Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.1|-7.9|0.133
71706863|NCT01654250|142931238|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
71706864|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.28||0.206|TWO_SIDED|95.0|-7.4|1.6|||Mixed Models Analysis|||Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.6|-7.4|0.206
71706865|NCT01654250|142931238|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.||||0.133
71706866|NCT01654250|142931238|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.28||0.496|TWO_SIDED|95.0|-6.0|2.9|||Mixed Models Analysis|||Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||2.9|-6.0|0.496
71706867|NCT01654250|142931238|SUPERIORITY_OR_OTHER|||||||0.133|||||||Mixed Models Analysis|||Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.||||0.133
71706868|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.56||0.007|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.4|-2.6|0.007
71706869|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.4|-3.6|<0.001
71706870|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-3.4|-1.2|||Mixed Models Analysis|||Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-1.2|-3.4|<0.001
71654286|NCT01287039|142825853|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.6595||||0.2572|TWO_SIDED|95.0|0.321|1.355||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.3550|0.3210|0.2572
71654287|NCT03438396|142825911|OTHER|The statistical hypotheses was tested to address ORR \<= 11% vs. ORR \> 11%.||||||0.0002|||||||one-sided exact test|||||||0.0002
71654288|NCT02006628|142825924|SUPERIORITY||Treatment difference (GWP42003-placebo)|-2.8||||0.1332|TWO_SIDED|95.0|-6.5|0.9|||ANCOVA|Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.||||0.9|-6.5|0.1332
71654289|NCT02006628|142825925|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0896|TWO_SIDED|95.0|0.86|8.0|||Regression, Logistic|Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.||||8.00|0.86|0.0896
71654290|NCT02006628|142825926|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.4||||0.0188|TWO_SIDED|95.0|-2.5|-0.2|||ANCOVA|||||-0.2|-2.5|0.0188
71654291|NCT02006628|142825927|SUPERIORITY||Treatment difference (GWP42003-placebo)|0.0||||0.9647|TWO_SIDED|95.0|-1.3|1.4|||ANCOVA|||||1.4|-1.3|0.9647
71654292|NCT02006628|142825928|SUPERIORITY||Treatment difference (GWP42003-placebo)|-1.3||||0.1963|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|||||0.7|-3.2|0.1963
71654293|NCT02006628|142825929|SUPERIORITY||Treatment difference (GWP42003-placebo)|-3.5||||0.1167|TWO_SIDED|95.0|-7.9|0.9|||ANCOVA|||||0.9|-7.9|0.1167
71654294|NCT02006628|142825930|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.3||||0.0443|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||||0.0|-0.5|0.0443
71654295|NCT02006628|142825931|SUPERIORITY||Treatment difference (GWP42003-placebo)|-0.5||||0.0182|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.0182
71706871|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.56||0.003|TWO_SIDED|95.0|-2.8|-0.6|||Mixed Models Analysis|||Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.6|-2.8|0.003
71654296|NCT02006628|142825932|SUPERIORITY||Treatment difference (GWP42003-placebo)|1.31||||0.0677|TWO_SIDED|95.0|-0.1|2.72|||ANCOVA|||||2.72|-0.10|0.0677
71654297|NCT01421342|142825933|SUPERIORITY||Odds Ratio (OR)|1.31||||0.076|TWO_SIDED|95.0|0.97|1.75||Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||1.75|0.97|0.076
71654298|NCT01421342|142825933|SUPERIORITY||Odds Ratio (OR)|1.42||||0.018|TWO_SIDED|95.0|1.06|1.89||Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||1.89|1.06|0.018
71654299|NCT01421342|142825933|SUPERIORITY||Odds Ratio (OR)|1.11||||0.46|TWO_SIDED|95.0|0.84|1.48||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.|Regression, Logistic||Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.||1.48|0.84|0.46
71654300|NCT01421342|142825934|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.7|TWO_SIDED|95.0|0.78|2.39|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR|||2.39|0.78|0.70
71706872|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56||0.097|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis|||Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.2|-2.0|0.097
71654301|NCT01421342|142825934|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.68|TWO_SIDED|95.0|0.65|1.94|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|||1.94|0.65|0.68
71654302|NCT01421342|142825934|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.87|TWO_SIDED|95.0|0.58|1.59|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.59|0.58|0.87
71654303|NCT01421342|142825935|SUPERIORITY||Odds Ratio (OR)|1.16||||0.28|TWO_SIDED|95.0|0.89|1.5|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.||1.50|0.89|0.28
71654304|NCT01421342|142825935|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.0001|TWO_SIDED|95.0|1.33|2.29|||Regression, Logistic|Stratified by participating medical center (site)|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.33|<0.0001
71706873|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.49|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.7|-1.5|0.490
71706874|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.56||0.164|TWO_SIDED|95.0|-1.9|0.3|||Mixed Models Analysis|||Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.3|-1.9|0.164
71826293|NCT04304534|143157032|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.98|||=|0.9158|TWO_SIDED|90.0|0.713|1.347|||Log Rank|||Comparison of the Pooled Asundexian group versus Placebo group||1.347|0.713|= 0.9158
71886564|NCT05227690|143293409|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.3783|TWO_SIDED|95.0|-0.1|0.2|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.2|-0.1|=0.3783
71654305|NCT01421342|142825935|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.17|2.05||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||2.05|1.17|0.002
71654306|NCT01421342|142825936|SUPERIORITY||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.68||After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|||1.68|0.95|0.11
71654307|NCT01421342|142825936|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.26|2.29|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.||2.29|1.26|<0.001
71654308|NCT01421342|142825936|SUPERIORITY||Odds Ratio (OR)|1.37||||0.043|TWO_SIDED|95.0|1.01|1.86||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic||Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|||1.86|1.01|0.043
71654309|NCT02493777|142825966|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
71654310|NCT02493777|142825967|SUPERIORITY||||||<|0.001|||||||Mixed model repeated measures analysis|||||||<0.001
71706875|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.94||0.004|TWO_SIDED|95.0|-4.6|-0.9|||Mixed Models Analysis|||Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.9|-4.6|0.004
71826294|NCT04304534|143157032|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.867|||=|0.5633|TWO_SIDED|90.0|0.577|1.302|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||1.302|0.577|= 0.5633
71826295|NCT04304534|143157032|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|0.875|||=|0.584|TWO_SIDED|90.0|0.587|1.306|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||1.306|0.587|= 0.584
71654311|NCT01642914|142825971|SUPERIORITY_OR_OTHER|||||||0.0054|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0054
71654312|NCT01642914|142825971|SUPERIORITY_OR_OTHER|||||||0.0012|ONE_SIDED||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution||||||0.0012
71654313|NCT01642914|142825984|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.193||||0.0006|TWO_SIDED|95.0|0.086|0.3||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.300|.086|0.0006
71654314|NCT01642914|142825984|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.17||||0.0022|TWO_SIDED|95.0|0.064|0.227||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||.227|.064|0.0022
71654315|NCT01642914|142825985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.37||||0.0054|TWO_SIDED|95.0|1.09|1.72|||Log Rank|Log-rank test stratified by geographic region.||||1.72|1.09|.0054
71654316|NCT01642914|142825985|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.24||||0.047|TWO_SIDED|95.0|0.99|1.55|||Log Rank|Log-rank test stratified by geographic region.||||1.55|0.99|0.0470
71654317|NCT01642914|142825991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.0264|TWO_SIDED|95.0|1.09|4.56||p-values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel|||||4.56|1.09|0.0264
71654318|NCT00754442|142826029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED|95.0||||see above|t-test, 2 sided|95%||The null hypothesis is that there is no statistical difference between patients and controls at baseline||||0.1
71826296|NCT04304534|143157032|OTHER|HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.|Hazard Ratio (HR)|1.202|||=|0.417|TWO_SIDED|90.0|0.828|1.747|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||1.747|0.828|= 0.417
71886565|NCT05227690|143293409|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06|=|0.2242|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.0|-0.2|=0.2242
71654319|NCT00754442|142826029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 4 hours||||0.002
71654320|NCT00754442|142826029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs||||0.003
71654321|NCT00296491|142826031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_ERROR_OF_MEAN|5.41|<|0.001||95.0|12.5|33.8|||t-test, 2 sided||Treatment Difference = FSC - MON|||33.8|12.5|<0.001
71654322|NCT00296491|142826032|NON_INFERIORITY_OR_EQUIVALENCE|Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance.|Mean Difference (Net)|-8.9|STANDARD_ERROR_OF_MEAN|8.0|<|0.127||95.0|-24.6|6.9|||t-test, 2 sided||Treatment Difference=FSC+MON-FSC|||6.9|-24.6|<0.127
71654323|NCT01300052|142826041|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|95.0|-14.3|21.8||||||Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.||21.8|-14.3|
71654324|NCT01231373|142826048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-4.63|-2.04|||ANCOVA|||Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.||-2.04|-4.63|<0.0001
71654325|NCT01231373|142826048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.74|||ANCOVA|||||-2.74|-5.26|<0.0001
71654326|NCT01231373|142826048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||<|0.0001|TWO_SIDED|95.0|-4.33|-1.77|||ANCOVA|||||-1.77|-4.33|<0.0001
71654327|NCT01231373|142826049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-0.88|-0.45|||ANCOVA|||||-0.45|-0.88|<0.0001
71706876|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
71706877|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-2.1|-5.8|<0.001
71706878|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.94||0.042|TWO_SIDED|95.0|-3.8|-0.1|||Mixed Models Analysis|||Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||-0.1|-3.8|0.042
71706879|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.94||0.118|TWO_SIDED|95.0|-3.3|0.4|||Mixed Models Analysis|||Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||0.4|-3.3|0.118
71706880|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.94||0.342|TWO_SIDED|95.0|-2.7|1.9|||Mixed Models Analysis|||Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-2.7|0.342
71826297|NCT04304534|143157033|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.275|||||TWO_SIDED|90.0|0.322|5.05||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||5.050|0.322|
71654328|NCT01231373|142826049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.078|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61|||ANCOVA|||||-0.61|-1.04|<0.0001
71654329|NCT01231373|142826049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.54|||ANCOVA|||||-0.54|-0.97|<0.0001
71654330|NCT01231373|142826050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||||-0.87|-1.59|<0.0001
71654331|NCT01231373|142826050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.9|-1.18|||ANCOVA|||||-1.18|-1.90|<0.0001
71654332|NCT01231373|142826050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.83|-1.11|||ANCOVA|||||-1.11|-1.83|<0.0001
71706881|NCT01654250|142931239|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.962|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis|||Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||1.9|-1.8|0.962
71706882|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean difference|25.3|STANDARD_ERROR_OF_MEAN|11.12||0.024|TWO_SIDED|95.0|3.4|47.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||47.1|3.4|0.024
71706883|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|11.12||0.001|TWO_SIDED|95.0|14.2|57.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||57.9|14.2|0.001
71706884|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|34.7|STANDARD_ERROR_OF_MEAN|11.12||0.002|TWO_SIDED|95.0|12.8|56.6|||Mixed Models Analysis|||Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.6|12.8|0.002
71706885|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|11.12||0.009|TWO_SIDED|95.0|7.4|51.1|||Mixed Models Analysis|||Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||51.1|7.4|0.009
71706886|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|11.12||0.261|TWO_SIDED|95.0|-9.3|34.4|||Mixed Models Analysis|||Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||34.4|-9.3|0.261
71706887|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|11.12||0.175|TWO_SIDED|95.0|-6.7|37.0|||Mixed Models Analysis|||Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||37.0|-6.7|0.175
71764861|NCT02343549|143031789|SUPERIORITY||12-Month Survival Rate|0.333||||0.537|TWO_SIDED|95.0|0.075|0.701||This p-value is only based on partial enrollment of Stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|Assuming the true 12-month survival rate is 0.30 under the null hypothesis, then this design will provide 90% power to detect a difference of 0.20 under the alternative hypothesis, assuming a one-sided alpha = 0.10 significance level. A Simon optimal 2-stage design with Stage 1 n=22 and a total of n=46 subjects was determined with the following rejection regions: For n = 22, the rejection region in number of subjects alive at 12 months is 0 - 7, and for n = 46 it is 8 - 17.||0.701|0.075|0.537
71764862|NCT02343549|143031790|OTHER|Estimation Only|Median|9.9|||||TWO_SIDED|95.0|4.8|12.8|||||The Kaplan Meier method was used to estimate median OS(in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||12.8|4.8|
71826298|NCT04304534|143157033|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.991|||||TWO_SIDED|90.0|0.479|8.273||||||Comparison of the Asundexian 50 mg group versus Placebo group||8.273|0.479|
71826299|NCT04304534|143157034|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.125|||||TWO_SIDED|90.0|0.696|1.819||||||Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group||1.819|0.696|
71706888|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|18.7|STANDARD_ERROR_OF_MEAN|11.12||0.094|TWO_SIDED|95.0|-3.2|40.5|||Mixed Models Analysis|||Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||40.5|-3.2|0.094
71826300|NCT04304534|143157034|OTHER||Cox Proportional Hazard|1.181|||||TWO_SIDED|90.0|0.686|2.031||||||Comparison of the Asundexian 20 mg group versus Placebo group||2.031|0.686|
71826301|NCT04304534|143157034|OTHER|HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.|Cox Proportional Hazard|1.07|||||TWO_SIDED|90.0|0.613|1.866||||||Comparison of the Asundexian 50 mg group versus Placebo group||1.866|0.613|
71826302|NCT04304534|143157037|OTHER|For all-cause mortality there is no competing event.|Cox Proportional Hazard|1.266|||=|0.6016|TWO_SIDED|90.0|0.603|2.658|||Log Rank|||Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group||2.658|0.603|= 0.6016
71886566|NCT05227690|143293409|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.8626|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.1|-0.1|=0.8626
71764863|NCT02343549|143031791|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median PFS (in months). The Greenwood method was used to estimate confidence limits of median progression free survival.|||10.4|4.8|
71764864|NCT02343549|143031792|OTHER|Estimation only|Response Rate|0.333|||||TWO_SIDED|95.0|0.075|0.701|||||Confidence interval estimated using the Clopper Pearson method.|||0.701|0.075|
71706889|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6|STANDARD_ERROR_OF_MEAN|11.44||0.049|TWO_SIDED|95.0|0.1|45.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||45.1|0.1|0.049
71706890|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4|STANDARD_ERROR_OF_MEAN|11.44||0.003|TWO_SIDED|95.0|11.9|56.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||56.9|11.9|0.003
71706891|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|STANDARD_ERROR_OF_MEAN|11.44||0.004|TWO_SIDED|95.0|10.5|55.4|||Mixed Models Analysis|||Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||55.4|10.5|0.004
71706892|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|11.44||0.019|TWO_SIDED|95.0|4.5|49.5|||Mixed Models Analysis|||Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||49.5|4.5|0.019
71706893|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean difference|8.6|STANDARD_ERROR_OF_MEAN|11.44||0.451|TWO_SIDED|95.0|-13.9|31.1|||Mixed Models Analysis|||Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||31.1|-13.9|0.451
71706894|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|11.44||0.394|TWO_SIDED|95.0|-12.7|32.2|||Mixed Models Analysis|||Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||32.2|-12.7|0.394
71706895|NCT01654250|142931240|SUPERIORITY_OR_OTHER||LS Mean difference|8.3|STANDARD_ERROR_OF_MEAN|11.44||0.466|TWO_SIDED|95.0|-14.1|30.8|||Mixed Models Analysis|||Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.||30.8|-14.1|0.466
71706896|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.367|TWO_SIDED||||||Fisher Exact|||All bleeds||||.367
71706897|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Fisher Exact|||All bleeds||||.104
71706898|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Fisher Exact|||All bleeds||||.864
71706899|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||All bleeds||||.002
71706900|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||1.000
71706901|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.029
71706902|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.807
71706903|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding||||0.002
71706904|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
71706905|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.119
71706906|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Major bleeds||||1.000
71706907|NCT00504556|142931247|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Fisher Exact|||Major bleeds||||0.023
71706908|NCT03142451|142931281|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|0.749||0.0031|TWO_SIDED|95.0|0.75|3.68|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, baseline inflammatory lesion count, and analysis center.||||3.68|0.75|0.0031
71706909|NCT03142451|142931282|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0273|TWO_SIDED|95.0|1.022|1.434||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.434|1.022|0.0273
71706910|NCT03142451|142931283|SUPERIORITY||Risk Ratio (RR)|1.21||||0.0171|TWO_SIDED|95.0|1.028|1.425||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.425|1.028|0.0171
71706911|NCT03142451|142931284|SUPERIORITY||Mean Difference (Final Values)|7.62|STANDARD_ERROR_OF_MEAN|2.626||0.0039|TWO_SIDED|95.0|2.46|12.77|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||12.77|2.46|0.0039
71706912|NCT03142451|142931285|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_ERROR_OF_MEAN|0.747||0.0004|TWO_SIDED|95.0|1.16|4.09|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 4||4.09|1.16|0.0004
71706913|NCT03142451|142931285|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|1.62|4.56|||ANCOVA|ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.||Statistical analysis for Week 8||4.56|1.62|<0.0001
71706914|NCT03142451|142931286|SUPERIORITY||Risk Ratio (RR)|1.685||||0.0201|TWO_SIDED|95.0|1.085|2.616||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 4||2.616|1.085|0.0201
71706915|NCT03142451|142931286|SUPERIORITY||Risk Ratio (RR)|1.191||||0.1278|TWO_SIDED|95.0|0.951|1.492||P-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical analysis for Week 8||1.492|0.951|0.1278
71706916|NCT03777176|142931313|SUPERIORITY|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate and number of hypoglycemic events during Weeks 2-4 as dependent variable.|Event rate ratio|0.85||||0.5028|TWO_SIDED|95.0|0.54|1.36|||Negative binomial regression|||The primary analysis was performed as a negative binominal regression analysis on the difference of the SMPG-detected hypoglycemia episode rate between treatment groups over the Weeks 2-4.||1.36|0.54|0.5028
71706917|NCT03777176|142931314|SUPERIORITY||Mean Difference (Net)|0.84||||0.6433|TWO_SIDED|95.0|-2.71|4.39||The P value should be interpreted with caution given the procedural issues (hypoglycemia at the beginning of the test, test meals not being the same, and some children only having 1 test) which affected the preplanned statistical evaluation.|ANCOVA|||||4.39|-2.71|0.6433
71706918|NCT03777176|142931315|SUPERIORITY||Mean Difference (Net)|0.15||||0.9653|TWO_SIDED|95.0|-6.48|6.78||There was 1 missing value at Baseline for the dasiglucagon + standard of care group.|ANCOVA|||||6.78|-6.48|0.9653
71706919|NCT03777176|142931316|SUPERIORITY||Event rate ratio|0.93||||0.8114|TWO_SIDED|95.0|0.49|1.74|||Negative binominal regression|The negative binomial regression used region and treatment group as fixed effects, and Baseline hypoglycemic rate as covariate.||||1.74|0.49|0.8114
71706920|NCT03636269|142931349|SUPERIORITY||Odds Ratio (OR)|1.61||||0.02|TWO_SIDED|95.0|1.08|2.41|||Cui, Hung, Wang|||||2.41|1.08|0.020
71706921|NCT03636269|142931350|SUPERIORITY||Odds Ratio (OR)|1.77||||0.01|TWO_SIDED|95.0|1.14|2.74|||Cui, Hung, Wang|||||2.74|1.14|0.010
71706922|NCT03636269|142931351|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.29||0.171|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|||||0.8|-4.3|0.171
71706923|NCT03636269|142931352|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.002|TWO_SIDED|95.0|-1.7|-0.4|||ANCOVA|||||-0.4|-1.7|0.002
71706924|NCT03992482|142931353|OTHER|||||||1|||||||Kruskal-Wallis|||||||1.000
71706925|NCT03992482|142931354|OTHER|||||||0.0044|||||||Mixed Models Analysis|||||||0.0044
71826303|NCT04304534|143157037|OTHER||Cox Proportional Hazard|0.996|||=|0.9945|TWO_SIDED|90.0|0.414|2.401|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.401|0.414|= 0.9945
71706926|NCT03992482|142931355|OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
71706927|NCT01368185|142931356|SUPERIORITY_OR_OTHER_LEGACY||% change SUA from baseline|4.6|STANDARD_DEVIATION|0.9|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SUA minus baseline SUA.|Comparison between Month 3 and Baseline||||<0.01
71706928|NCT01368185|142931357|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||||||<0.0001
71706929|NCT01368185|142931358|SUPERIORITY_OR_OTHER_LEGACY||% change DBP from Baseline|-7.1|STANDARD_DEVIATION|0.4|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 DBP minus baseline DBP (n=1239).|Comparison between Month 3 and Baseline||||<0.01
71706930|NCT01368185|142931359|SUPERIORITY_OR_OTHER_LEGACY||% change SBP from Baseline|-9.1|STANDARD_DEVIATION|0.3|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SBP minus baseline SBP (n=1245).|Comparison between Month 3 and Baseline||||<0.01
71706931|NCT01429623|142931392|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.16|TWO_SIDED|95.0|0.74|3.25|||Log Rank|||||3.25|0.74|<0.16
71706932|NCT01429623|142931393|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.24|<|0.61|TWO_SIDED||||||Mixed Models Analysis|||||||<0.61
71706933|NCT01429623|142931394|SUPERIORITY||Mean Difference (Net)|-0.066|STANDARD_ERROR_OF_MEAN|0.085|<|0.32|TWO_SIDED||||||Mixed Models Analysis|||||||<0.32
71706934|NCT01429623|142931395|SUPERIORITY||Mean Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|1.17|<|0.97|TWO_SIDED||||||Mixed Models Analysis|||||||<0.97
71706935|NCT00793611|142931406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.07|||||||t-test, 2 sided|19 degrees of freedom||ITT between group differences in change scores compared for behavioral therapy and hypnotherapy groups. Power analysis: This is a pilot study underpowered find between group differences based on our power analysis(a 20% difference between groups would require 88 women, assuming 80% power and α=0.05 based on Freeman's study cited later). The purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes||||.07
71706936|NCT00793611|142931407|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||intent to treat.||||.17
71706937|NCT00793611|142931408|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||intent to treat||||.009
71706938|NCT03757715|142931419|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.16
71706939|NCT03757715|142931420|SUPERIORITY|||||||0.42|||||||t-test, 1 sided|||||||0.42
71706940|NCT03156621|142931421|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-51.2|-19.9||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM||p-value vs Placebo|||-19.9|-51.2|<0.0001
71706941|NCT03156621|142931422|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-42.3|-17.3||p-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-17.3|-42.3|< 0.0001
71706942|NCT03156621|142931423|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|-47.6|-18.2||P-value taken from MMRM (mixed-effect model with repeated measures) analysis|MMRM|||||-18.2|-47.6|< 0.0001
71706943|NCT03156621|142931424|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_DEVIATION|6.2|<|0.0001|TWO_SIDED|95.0|-38.9|-14.0||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||-14.0|-38.9|< 0.0001
71706944|NCT03156621|142931425|SUPERIORITY||Odds Ratio, log|12.2|||=|0.0004|TWO_SIDED|95.0|3.1|48.8|||Regression, Logistic|||||48.8|3.1|= 0.0004
71706945|NCT03156621|142931426|SUPERIORITY||Odds Ratio, log|36.5|||=|0.001|TWO_SIDED|95.0|4.3|308.9|||Regression, Logistic|||||308.9|4.3|= 0.0010
71826304|NCT04304534|143157037|OTHER||Cox Proportional Hazard|1.506|||=|0.4085|TWO_SIDED|90.0|0.667|3.405|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.405|0.667|= 0.4085
71826305|NCT00300456|143157044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71886567|NCT05227690|143293409|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.6106|TWO_SIDED|95.0|-0.1|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.1|-0.1|=0.6106
71654333|NCT02990806|142826074|EQUIVALENCE|A test for equivalence was carried out using an asymmetric margin (-12%, 15%) pre-specified in protocol and a two 1-sided test (TOST) analysis with α=0.05 for each 1-sided statistical test.|Percentage difference|3.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-4.3|11.5||||||||11.5|-4.3|
71706946|NCT03156621|142931427|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|95.0|-41.5|-15.2|||Regression model|||||-15.2|-41.5|< 0.0001
71706947|NCT03156621|142931428|SUPERIORITY||Odds Ratio (OR)|17.7|||=|0.0017|TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist||Exact Conditional Logistic Regression||||||3.3|= 0.0017
71706948|NCT03156621|142931429|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|=|0.3541|TWO_SIDED|95.0|-4.1|11.3||P-value taken from MMRM (mixed-effect model with repeated measures) analysis.|MMRM|||||11.3|-4.1|= 0.3541
71706949|NCT03156621|142931430|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
71706950|NCT03156621|142931431|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_DEVIATION|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
71706951|NCT03156621|142931432|SUPERIORITY||Least squares (LS) mean difference|-35.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-51.2|-19.9||||||||-19.9|-51.2|
71706952|NCT03156621|142931433|SUPERIORITY||Least squares (LS) mean difference|-29.8|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-43.3|-17.3||||||||-17.3|-43.3|
71706953|NCT03156621|142931434|SUPERIORITY||Least squares (LS) mean difference|-32.9|STANDARD_ERROR_OF_MEAN|7.4|||TWO_SIDED|95.0|-47.6|-18.2||||||||-18.2|-47.6|
71706954|NCT03156621|142931435|SUPERIORITY||Least squares (LS) mean difference|-26.5|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-28.9|-14.0||||||||-14.0|-28.9|
71706955|NCT03156621|142931436|SUPERIORITY||Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-41.5|-15.2||||||||-15.2|-41.5|
71706956|NCT03156621|142931437|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.1|11.3||||||||11.3|-4.1|
71706957|NCT03156621|142931438|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-25.2|2.6||||||||2.6|-25.2|
71706958|NCT03156621|142931439|SUPERIORITY||Least squares (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-3.6|10.7||||||||10.7|-3.6|
71706959|NCT03156621|142931440|SUPERIORITY||Odds Ratio (OR)|12.2|||||TWO_SIDED|95.0|3.1|48.8||||||≥15% reduction||48.8|3.1|
71706960|NCT03156621|142931440|SUPERIORITY|≥ 30% reduction|Odds Ratio (OR)|36.5|||||TWO_SIDED|95.0|4.3|308.9||||||||308.9|4.3|
71706961|NCT03156621|142931440|SUPERIORITY||Odds Ratio (OR)|17.7|||||TWO_SIDED|95.0|3.3||Maximum likelihood estimate does not exist|||||≥ 50% reduction|||3.3|
71706962|NCT03156621|142931441|SUPERIORITY||Least squares (LS) mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.6|-0.1||||||||-0.1|-0.6|
71706963|NCT04299425|142931447|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71706964|NCT04299425|142931448|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71706965|NCT04299425|142931450|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71706966|NCT04299425|142931451|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71706967|NCT01657500|142931458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|See above|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Main outcome measure was endothelial cell loss at 6 months after EK. Sample size and statistical power calculations for testing equivalence of means within 10% range were performed at 80% power/0.025 level of significance. 20% variability was assumed. 6-month endothelial cell loss) should not differ significantly for surgeon-prepared versus eye bank-prepared tissue. Assuming pairs of corneas matched by pt. diagnosis and other characteristics, the required sample size was 34 donor pairs.||||< 0.05
71706968|NCT06083493|142931471|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71706969|NCT06083493|142931472|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
71706970|NCT00449007|142931503|SUPERIORITY||Mean Difference (Final Values)|4.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Difference between 6 months and baseline for Bupropion treated group.~Due to the low number of participants, the results are unreliable."||||1.0
71706971|NCT01452789|142931534|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
71706972|NCT01452789|142931535|SUPERIORITY||||||<|0.05|||||||van Elteren|||||||<0.05
71706973|NCT01452789|142931536|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
71706974|NCT00066170|142931538|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
71706975|NCT00066170|142931538|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's|||||||<0.001
71706976|NCT00098293|142931570|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.0|||||ONE_SIDED|97.5|-9.5|||||||Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-9.5|
71764865|NCT02343549|143031793|OTHER|Estimation only|Disease Control Rate|1.0|||||TWO_SIDED|95.0|0.664|1.0||||||||1.000|0.664|
71886568|NCT05227690|143293410|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.4219|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 3-- Emraclidine 30 mg versus Placebo||0.1|0.0|=0.4219
71706977|NCT00098293|142931570|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.2|||||ONE_SIDED|97.5|-10.9|||||||Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.9|
71706978|NCT00098293|142931571|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.1|||||ONE_SIDED|97.5|-10.5|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.5|
71706979|NCT00098293|142931571|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-4.4|||||ONE_SIDED|97.5|-11.2|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-11.2|
71706980|NCT00098293|142931572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.4485|TWO_SIDED|95.0|0.64|1.22|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio \> 1 would favor maraviroc.||1.22|0.64|0.4485
71706981|NCT00098293|142931572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.2724|TWO_SIDED|95.0|0.61|1.15|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.15|0.61|0.2724
71706982|NCT00098293|142931573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.3943|TWO_SIDED|95.0|0.65|1.19|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.19|0.65|0.3943
71706983|NCT00098293|142931573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.1289|TWO_SIDED|95.0|0.59|1.07|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \> 1 would favor maraviroc.||1.07|0.59|0.1289
71706984|NCT00098293|142931574|SUPERIORITY_OR_OTHER||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.1077||0.2741|TWO_SIDED|95.0|-0.094|0.329|||ANCOVA|||Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.329|-0.094|0.2741
71706985|NCT00098293|142931574|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1162||0.3899|TWO_SIDED|95.0|-0.128|0.328|||ANCOVA|||Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.328|-0.128|0.3899
71706986|NCT00098293|142931575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.1002||0.2693|TWO_SIDED|95.0|-0.086|0.307|||ANCOVA|||Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.307|-0.086|0.2693
71706987|NCT00098293|142931575|SUPERIORITY_OR_OTHER||LS Mean Difference|0.089|STANDARD_ERROR_OF_MEAN|0.1121||0.427|TWO_SIDED|95.0|-0.131|0.309|||ANCOVA|||Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.||0.309|-0.131|0.4270
71706988|NCT00098293|142931576|SUPERIORITY_OR_OTHER||LS Mean Difference|26.34|STANDARD_ERROR_OF_MEAN|9.827||0.0075|TWO_SIDED|95.0|7.04|45.63|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||45.63|7.04|0.0075
71706989|NCT00098293|142931576|SUPERIORITY_OR_OTHER||LS Mean Difference|35.44|STANDARD_ERROR_OF_MEAN|11.419||0.002|TWO_SIDED|95.0|13.02|57.86|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||57.86|13.02|0.0020
71826306|NCT00300456|143157044|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71706990|NCT00098293|142931577|SUPERIORITY_OR_OTHER||LS Mean Difference|166.29|STANDARD_ERROR_OF_MEAN|25.04|<|0.0001|TWO_SIDED|95.0|117.13|215.46|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||215.46|117.13|<0.0001
71706991|NCT00098293|142931577|SUPERIORITY_OR_OTHER||LS Mean Difference|172.22|STANDARD_ERROR_OF_MEAN|25.471|<|0.0001|TWO_SIDED|95.0|122.21|222.23|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.||222.23|122.21|<0.0001
71706992|NCT00098293|142931578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.5874|TWO_SIDED|95.0|0.83|1.45|||Log Rank|||Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.45|0.83|0.5874
71706993|NCT00098293|142931578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4811|TWO_SIDED|95.0|0.86|1.4|||Log Rank|||Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \< 1 would favor maraviroc.||1.40|0.86|0.4811
71706994|NCT00098293|142931585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\>) -10%.|Difference in Percentage|-3.2|||||ONE_SIDED|97.5|-10.2|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-10.2|
71706995|NCT00098293|142931585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \> -10%.|Difference in Percentage|-5.8|||||ONE_SIDED|97.5|-12.8|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|||-12.8|
71706996|NCT00098293|142931586|SUPERIORITY_OR_OTHER||Difference in Percentage|0.6|||||ONE_SIDED|97.5|-6.4|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-6.4|
71706997|NCT00098293|142931586|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||ONE_SIDED|97.5|-7.4|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.4|
71706998|NCT00098293|142931587|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||ONE_SIDED|97.5|-7.9|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-7.9|
71706999|NCT00098293|142931587|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.9|||||ONE_SIDED|97.5|-11.5|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|||-11.5|
71707000|NCT01370642|142931588|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.0|||<|0.001|TWO_SIDED|95.0|17.2|40.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by Interleukin 28B (IL28B) and age utilizing Cochran-Mantel-Haenszel weights.||40.5|17.2|<0.001
71826307|NCT00300456|143157045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71764866|NCT02343549|143031794|OTHER|Estimation only.|Median|8.1|||||TWO_SIDED|95.0|3.7|8.6|||||The Kaplan Meier method was used to estimate median duration of response (in months). The Greenwood method was used to estimate confidence limits of median duration of response.|||8.6|3.7|
71826308|NCT00300456|143157045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71707001|NCT01370642|142931588|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|28.6|||<|0.001|TWO_SIDED|95.0|17.4|40.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||40.0|17.4|<0.001
71707002|NCT01370642|142931589|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|30.0|||<|0.001|TWO_SIDED|95.0|18.1|41.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.5|18.1|<0.001
71707003|NCT01370642|142931589|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|29.6|||<|0.001|TWO_SIDED|95.0|18.3|41.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||41.0|18.3|<0.001
71707004|NCT01370642|142931590|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|78.1|||<|0.001|TWO_SIDED|95.0|68.2|85.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||85.3|68.2|<0.001
71707005|NCT01370642|142931590|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|76.7|||<|0.001|TWO_SIDED|95.0|66.7|84.1|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||84.1|66.7|<0.001
71707006|NCT01370642|142931591|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|48.4|||<|0.001|TWO_SIDED|95.0|37.2|58.9|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||58.9|37.2|<0.001
71707007|NCT01370642|142931591|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|49.6|||<|0.001|TWO_SIDED|95.0|38.5|60.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||60.0|38.5|<0.001
71707008|NCT01370642|142931592|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.0|||<|0.001|TWO_SIDED|95.0|8.1|27.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.3|8.1|<0.001
71707009|NCT01370642|142931592|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentages|17.8|||<|0.001|TWO_SIDED|95.0|9.3|27.8|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.||27.8|9.3|<0.001
71707010|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|4.1||||0.385|TWO_SIDED|95.0|-5.4|13.7|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||13.7|-5.4|0.385
71707011|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|-2.2||||0.67|TWO_SIDED|95.0|-12.6|8.1|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.||8.1|-12.6|0.670
71707012|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|-4.1||||0.557|TWO_SIDED|95.0|-17.5|9.5|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||9.5|-17.5|0.557
71707013|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|-12.7||||0.072|TWO_SIDED|95.0|-26.2|1.2|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.||1.2|-26.2|0.072
71707014|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|0.0|||>|0.999|TWO_SIDED|95.0|-7.9|7.9|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||7.9|-7.9|>0.999
71707015|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|5.2||||0.22|TWO_SIDED|95.0|-3.3|14.2|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.||14.2|-3.3|0.220
71707016|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|15.3||||0.032|TWO_SIDED|95.0|1.3|28.7|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||28.7|1.3|0.032
71707017|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|5.6||||0.432|TWO_SIDED|95.0|-8.4|19.4|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.||19.4|-8.4|0.432
71707018|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|8.2||||0.252|TWO_SIDED|95.0|-5.8|21.8|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||21.8|-5.8|0.252
71707019|NCT01370642|142931593|SUPERIORITY_OR_OTHER||Difference in percentages|0.5||||0.942|TWO_SIDED|95.0|-13.4|14.4|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.||14.4|-13.4|0.942
71707020|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.2|||||TWO_SIDED|95.0|-3.5|-3.0|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.0|-3.5|
71707021|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 2|-3.5|||||TWO_SIDED|95.0|-3.7|-3.2|||Constrained LDA Model|||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-3.2|-3.7|
71707022|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.0|||||TWO_SIDED|95.0|-3.3|-2.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.7|-3.3|
71707023|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 4|-3.1|||||TWO_SIDED|95.0|-3.4|-2.8|||Constrained LDA Model|||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-2.8|-3.4|
71707024|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-1.9|||||TWO_SIDED|95.0|-2.2|-1.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.6|-2.2|
71707025|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 8|-2.0|||||TWO_SIDED|95.0|-2.3|-1.7|||Constrained LDA Model|||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.7|-2.3|
71707026|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
71707027|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 12|-1.4|||||TWO_SIDED|95.0|-1.7|-1.1|||Constrained LDA Model|||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-1.1|-1.7|
71707028|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.5|-1.1|
71826309|NCT00300456|143157046|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71826310|NCT00300456|143157046|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71826311|NCT00843193|143157091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1955|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.27|0.1955
71707029|NCT01370642|142931594|SUPERIORITY_OR_OTHER||LS Mean Difference at Week 24|-0.9|||||TWO_SIDED|95.0|-1.2|-0.6|||Constrained LDA Model|||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.||-0.6|-1.2|
71707030|NCT01927861|142931608|OTHER||Treatment difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.38|0.88|||ANCOVA|||The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline height SDS as a covariate.||0.88|0.38|< 0.0001
71707031|NCT00987935|142931676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.357|||||TWO_SIDED|95.0|0.802|2.296|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.296|0.802|
71707032|NCT00987935|142931677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|||||TWO_SIDED|95.0|0.73|2.014|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.014|0.730|
71707033|NCT00987935|142931681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|||||TWO_SIDED|95.0|0.728|1.932|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.932|0.728|
71707034|NCT00987935|142931682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.593|1.489|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.489|0.593|
71826312|NCT00843193|143157091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0193|TWO_SIDED|95.0|-0.34|-0.03|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||-0.03|-0.34|0.0193
71826313|NCT00843193|143157091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.6156|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.14|-0.23|0.6156
71826314|NCT00843193|143157091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.4672|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||Comparison between GSK679586 120 mg/kg and Placebo at Week 12||0.14|-0.31|0.4672
71826315|NCT00843193|143157094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7693|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2||0.06|-0.08|0.7693
71826316|NCT00843193|143157094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8987|TWO_SIDED|95.0|-0.08|0.09|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4||0.09|-0.08|0.8987
71826317|NCT00843193|143157094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.4231|TWO_SIDED|95.0|-0.12|0.05|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8||0.05|-0.12|0.4231
71654334|NCT00720226|142826192|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Participants demonstrating 5-35% emphysema on baseline CT scan||||0.06
71654335|NCT00720226|142826193|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Participants with 5-35% emphysema at baseline||||0.55
71654336|NCT01770431|142826273|SUPERIORITY||chi-squared|14.7315||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
71654337|NCT01770431|142826274|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.81|||Regression, Cox|||||0.81|0.55|<0.0001
71654338|NCT01949116|142826275|NON_INFERIORITY|The P-value for the risk difference is from an asymptotic non-inferiority analysis for the proportion (risk) difference with a 15% non-inferiority margin.|Risk Difference (RD)|0.072||||0.0367|ONE_SIDED|90.0||0.134|||Farrington-Manning score (exact)||LDMTX - Placebo|||0.134||0.0367
71654339|NCT01949116|142826276|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.55|TWO_SIDED|95.0|-0.67|0.85|||Wilcoxon (Mann-Whitney)|Stratified by Statin Use (study stratification factor)||||0.85|-0.67|0.55
71654340|NCT03407118|142826289|SUPERIORITY||ratio of least square means|0.967|||||TWO_SIDED|95.0|0.803|1.17||||||||1.17|0.803|
71654341|NCT00788593|142826358|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|1.023||||0.228|TWO_SIDED|95.0|-0.656|2.701|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.||2.701|-0.656|0.228
71654342|NCT00788593|142826359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71654343|NCT00788593|142826359|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71654344|NCT00788593|142826360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71654345|NCT00788593|142826360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71654346|NCT03020719|142826363|SUPERIORITY||Mean Difference (Final Values)|-0.081||||0.2521|TWO_SIDED|95.0|-0.221|0.059|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\< 6 years, ≥ 6 years), and baseline weight-for-age z-score category (\< -0.52, ≥ -0.52).|Model incorporates Week 12 weight-for-age z-score, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.059|-0.221|0.2521
71654347|NCT03020719|142826364|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.089|TWO_SIDED|95.0|-0.18|0.01|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.01|-0.18|0.0890
71654348|NCT03020719|142826365|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.573|TWO_SIDED|95.0|-0.28|0.15|||Mixed Models Analysis|Model adjusted from randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.15|-0.28|0.5730
71654349|NCT03020719|142826366|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.4259|TWO_SIDED|95.0|-0.17|0.4|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.|||0.40|-0.17|0.4259
71654350|NCT03020719|142826367|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.4666|TWO_SIDED|95.0|-2.06|0.96|||ANCOVA|Model adjusted for randomization strata: sex, baseline age (\<6 years, ≥6 years), and baseline weight-for-age z-score category (\< -0.52, ≥-0.52).||||0.96|-2.06|0.4666
71654351|NCT03020719|142826368|SUPERIORITY||Difference in % of Participants with AE|0.0||||1|TWO_SIDED|95.0|-13.6|13.6|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||13.6|-13.6|1.0000
71654352|NCT03020719|142826368|SUPERIORITY||Difference in % of Participants with SAE|-13.3||||0.1945|TWO_SIDED|95.0|-30.5|2.9|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.|||2.9|-30.5|0.1945
71654353|NCT03020719|142826369|SUPERIORITY||Rate Ratio|1.21||||0.1087|TWO_SIDED|95.0|0.96|1.52|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||1.52|0.96|0.1087
71654354|NCT03020719|142826369|SUPERIORITY||Rate Ratio|0.12||||0.0122|TWO_SIDED|95.0|0.01|0.67|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.||0.67|0.01|0.0122
71764867|NCT02343549|143031795|OTHER|Estimation Only|Median|7.9|||||TWO_SIDED|95.0|4.8|10.4|||||The Kaplan Meier method was used to estimate median duration of disease control (in months). The Greenwood method was used to estimate confidence limits of median duration of disease control.|||10.4|4.8|
71764868|NCT04343235|143031810|SUPERIORITY|||||||0.21|||||||Fisher Exact|||||||0.21
71764869|NCT04343235|143031811|SUPERIORITY|||||||0.7||||||Main effect for Randomization group|ANOVA|||||||0.70
71764870|NCT04343235|143031812|SUPERIORITY|||||||0.77|||||||ANOVA|Main effect for randomization group||||||0.77
71764871|NCT04343235|143031813|SUPERIORITY|||||||0.54|||||||ANOVA|Main effect for randomization group||||||0.54
71764872|NCT04343235|143031814|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.0||0.47|TWO_SIDED|95.0|-1.5|3.1|||t-test, 2 sided|||||3.1|-1.5|0.47
71764873|NCT04343235|143031815|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
71764874|NCT04343235|143031816|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71764875|NCT00865280|143031817|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-2.0|||||TWO_SIDED|95.0|-12.4|8.5|||||The 95% confidence interval (CI) was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.5|-12.4|
71764876|NCT00865280|143031818|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-3.6|||||TWO_SIDED|95.0|-15.5|8.3|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.3|-15.5|
71654355|NCT00515034|142826371|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|-13.8|||||TWO_SIDED|95.0|-54.4|26.8|||normal approximation to the binomial||Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are provided.||26.8|-54.4|
71764877|NCT00865280|143031819|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
71764878|NCT00865280|143031820|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
71764879|NCT00865280|143031821|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|7.7|||||TWO_SIDED|95.0|-11.2|26.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||26.6|-11.2|
71764880|NCT00865280|143031822|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.3|||||TWO_SIDED|95.0|-8.3|7.6|||||The 95% CI was based on a normal approximation to the binomial distribution with continuity correction. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||7.6|-8.3|
71764881|NCT01099449|143031848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.73
71764882|NCT01099449|143031848|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.||||.29
71764883|NCT01099449|143031849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.054|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.054
71654356|NCT00515034|142826372|NON_INFERIORITY_OR_EQUIVALENCE|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|18.7|||||TWO_SIDED|95.0|-13.2|50.6|||normal approximation to binomial||Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are presented.||50.6|-13.2|
71654357|NCT01392326|142826378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53|||<|0.0001|TWO_SIDED|95.0|3.46|8.85|||Regression, Logistic|||||8.85|3.46|<0.0001
71826318|NCT00843193|143157094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0537|TWO_SIDED|95.0|-0.19|0.0|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 12||0.00|-0.19|0.0537
71826319|NCT02982213|143157108|SUPERIORITY||Mean Difference (Net)|0.025||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.001
71654358|NCT01392326|142826378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.39|||<|0.0001|TWO_SIDED|95.0|3.37|8.62|||Regression, Logistic|||||8.62|3.37|<0.0001
71654359|NCT02508259|142826388|EQUIVALENCE|The null hypothesis was that before and after treatment ADOS scores were equivalent.|Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.55||0.0028|TWO_SIDED|95.0|-2.3|-0.9|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.9|-2.3|0.0028
71707035|NCT02222181|142931692|SUPERIORITY_OR_OTHER|||||||0.23|||||||t-test, 1 sided|||||||0.23
71707036|NCT02222181|142931693|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71707037|NCT02222181|142931694|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||||||0.03
71707038|NCT02222181|142931695|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71707039|NCT02222181|142931696|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 1 sided|||||||0.025
71707040|NCT02222181|142931697|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71707041|NCT02222181|142931698|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71707042|NCT00345592|142931699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987|||||TWO_SIDED|95.0|0.684|1.503||||||||1.503|0.684|
71707043|NCT01245049|142931748|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups'difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|0.56|||||TWO_SIDED|95.0|-3.55|3.14|||Standardized asymptotic|||Non-inferiority in terms of booster response to D||3.14|-3.55|
71764884|NCT01099449|143031849|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.27|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.27
71764885|NCT01099449|143031850|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.29
71764886|NCT01099449|143031850|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in\>\> primary analysis.||||||0.25|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.||||.25
71764887|NCT01099449|143031853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.89|||||||Kruskal-Wallis|||||||.89
71764888|NCT01099449|143031853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Kruskal Wallis Analysis||||||0.496|||||||Kruskal-Wallis|||||||.496
71764889|NCT01099449|143031854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.52|||||||Chi-squared|||||||.52
71764890|NCT01099449|143031854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Chi-Squared Analysis||||||0.66|||||||Chi-squared|||||||.66
71764891|NCT00612105|143031858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.2537|TWO_SIDED|95.0|-1.171|0.312|||ANCOVA|||||0.312|-1.171|0.2537
71764892|NCT00509145|143031881|SUPERIORITY||Risk Ratio (RR)|0.77|STANDARD_ERROR_OF_MEAN|0.066||0.0024|TWO_SIDED|95.0|0.65|0.911|||Over-dispersed Poisson Regression||Laquinimod 0.6 mg vs. placebo|Response variable: number of relapses during 24 months. Offset based on the log of subject's exposure in years was employed to adjust for variability of treatment exposure. In addition to the treatment group, the Poisson regression model included the following covariates: baseline EDSS score, log of prior 2-year number of relapses+1 and Country or Geographical Region (CGR).||0.911|0.650|0.0024
71707044|NCT01245049|142931748|NON_INFERIORITY|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups' difference \[Repevax Group minus Boostrix Polio Group\] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups' difference in booster response rate ≤10%.|Percentage difference|1.7|||||TWO_SIDED|95.0|-2.43|4.9||||||Non-inferiority in terms of booster response to T||4.9|-2.43|
71707045|NCT01245049|142931750|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.|Difference in adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.65|1.28|||ANCOVA|||Immune response difference to anti-Polio 1 antigen||1.28|0.65|
71707046|NCT01245049|142931750|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|0.78|||||TWO_SIDED|95.0|0.54|1.12|||ANCOVA|||Immune response difference to anti-Polio 2 antigen||1.12|0.54|
71707047|NCT01245049|142931750|NON_INFERIORITY|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups' (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|1.3|||||TWO_SIDED|95.0|0.93|1.84|||ANCOVA|||Immune response difference to anti-Polio 3 antigen||1.84|0.93|
71707048|NCT00324857|142931791|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||"Please note that although the outcome is measured using a Likert scale, for the analysis we dichotomized the results.~P-value not adjusted for multiple comparison. Lastly, \<0.05 is the actual computed P-value."|Regression, Logistic|||Comparisons of the baseline demographic and clinical characteristics (TKR) across the 4 intervention groups were performed using chi-square tests for categorical data and analysis of variance for continuous variables. Willingness were compared across the groups over time using mixed-effect logistic regressions for dichotomous outcomes.||||<0.05
71707049|NCT01557244|142931793|SUPERIORITY|||||||0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an analysis of covariance (ANCOVA) model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||0.0001
71707050|NCT01557244|142931793|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
71707051|NCT01557244|142931793|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline maximum cystometric bladder capacity and baseline weight.||||<.0001
71707052|NCT01557244|142931793|OTHER||Difference in Least square (LS) Mean|-29.06|||||TWO_SIDED|95.0|-71.42|13.31||||||||13.31|-71.42|
71707053|NCT01557244|142931793|OTHER||Difference in LS Mean|-3.82|||||TWO_SIDED|95.0|-45.87|38.23||||||||38.23|-45.87|
71707054|NCT01557244|142931794|SUPERIORITY|||||||0.2334|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.2334
71764893|NCT01994889|143031886|SUPERIORITY|||||||0.0006|||||||Finkelstein-Schoenfeld Method|||||||0.0006
71764894|NCT01994889|143031887|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0259|TWO_SIDED|95.0|0.508|0.958|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.958|0.508|0.0259
71764895|NCT01994889|143031888|SUPERIORITY||Risk Ratio (RR)|0.6761|||<|0.0001|TWO_SIDED|95.0|0.5639|0.8107||Poisson regression analysis with treatment, TTR genotype, NYHA baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors adjusted for treatment duration.|Poisson regression analysis|||||0.8107|0.5639|<0.0001
71764896|NCT01994889|143031889|SUPERIORITY||Least Square Mean Difference|75.68|STANDARD_ERROR_OF_MEAN|9.236|<|0.0001|TWO_SIDED|95.0|57.56|93.8|||Mixed Model Repeated Measures ANCOVA|||L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and participant within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.||93.80|57.56|<.0001
71764897|NCT01994889|143031890|SUPERIORITY||LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|9.48|17.83|||Mixed Model Repeated Measures ANCOVA|||Change at Month 30||17.83|9.48|<.0001
71764898|NCT01994889|143031891|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.0383|TWO_SIDED|95.0|0.488|0.98|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.980|0.488|0.0383
71764899|NCT01994889|143031892|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71654360|NCT02508259|142826389|EQUIVALENCE|The child-specific difference in EOWPVT scores were compared for equivalence before and 6-weeks after suramin treatment|Mean Difference (Net)|-4.2|STANDARD_DEVIATION|8.3||0.32|TWO_SIDED|95.0|-14.5|6.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||6.1|-14.5|0.32
71654361|NCT02508259|142826390|EQUIVALENCE|In this analysis, the null hypothesis was tested that the child-specific ABC subscores for stereotypy were unchanged before and after suramin treatment.|Mean Difference (Net)|-4.0|STANDARD_DEVIATION|2.3||0.019|TWO_SIDED|95.0|-6.9|-1.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-1.1|-6.9|0.019
71654362|NCT02508259|142826391|EQUIVALENCE|In this analysis, we tested the equivalence of the child-specific ATEC subscore for language before and 6-weeks after treatment with suramin.|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|1.4||0.034|TWO_SIDED|95.0|-2.7|-0.49|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.49|-2.7|0.034
71654363|NCT02508259|142826392|EQUIVALENCE|In this analysis, overall ASD symptom scores, measured by CGI were compared between suramin and placebo groups.|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|1.04||0.05|TWO_SIDED|95.0|-3.4|-0.15|||ANOVA|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||-0.15|-3.4|0.05
71707055|NCT01557244|142931794|SUPERIORITY|||||||0.5087|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.5087
71764900|NCT02969655|143031908|NON_INFERIORITY|Non-inferiority was established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to \<0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.|Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.11|0.23||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.|||0.23|-0.11|<.0001
71764901|NCT02969655|143031909|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7442|TWO_SIDED|95.0|0.34|1.71||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.|||1.71|0.34|0.7442
71826320|NCT02982213|143157112|EQUIVALENCE|Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.||||||0.001|TWO_SIDED|95.0|||||McNemar|||||||.001
71707056|NCT01557244|142931794|SUPERIORITY|||||||0.3333|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline detrusor pressure at maximum bladder capacity and baseline weight.||||0.3333
71707057|NCT01557244|142931794|OTHER||Difference in LS Mean|-0.47|||||TWO_SIDED|95.0|-7.28|6.33||||||||6.33|-7.28|
71707058|NCT01557244|142931794|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-5.96|7.6||||||||7.60|-5.96|
71707059|NCT01557244|142931796|SUPERIORITY|||||||0.0336|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0336
71764902|NCT01711216|143031981|SUPERIORITY_OR_OTHER|||||||0.3181|TWO_SIDED|||||Test statistic (d.f.) 1.0157 (1) A Mantel-Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.|Mantel Haenszel|||Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)||||0.3181
71764903|NCT02744040|143032044|OTHER|||||||0.048||||||Multiple hypothesis testing was performed using Tukey's Honest Significant Difference (HSD) procedure.|Mixed Effects Models|||Total HIV DNA at the time of ART initiation in each of the three EDDI groups||||0.048
71764904|NCT02744040|143032045|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71764905|NCT02744040|143032045|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71764906|NCT02744040|143032045|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71707060|NCT01557244|142931796|SUPERIORITY|||||||0.0327|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0327
71707061|NCT01557244|142931796|SUPERIORITY|||||||0.0017|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder volume at first IDC and baseline weight.||||0.0017
71707062|NCT01557244|142931796|OTHER||Difference in LS Mean|-10.78|||||TWO_SIDED|95.0|-48.75|27.19||||||||27.19|-48.75|
71707063|NCT01557244|142931796|OTHER||Difference in LS Mean|-15.25|||||TWO_SIDED|95.0|-50.15|19.64||||||||19.64|-50.15|
71764907|NCT02744040|143032045|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71764908|NCT02744040|143032045|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71764909|NCT02744040|143032045|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in total HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for Total HIV DNA.||||<0.0001
71764910|NCT02744040|143032046|OTHER||||||>|0.05||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||Integrated HIV DNA at the time of ART initiation in each of the three EDDI groups||||>0.05
71826321|NCT01543685|143157117|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|441.8|STANDARD_ERROR_OF_MEAN|129.6|<|0.001|TWO_SIDED|95.0|187.1|696.5|||ANCOVA|||||696.5|187.1|<0.001
71826322|NCT01543685|143157117|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|260.2|STANDARD_ERROR_OF_MEAN|130.3||0.046|TWO_SIDED|95.0|4.1|516.3|||ANCOVA|||||516.3|4.1|0.046
71707064|NCT01557244|142931797|SUPERIORITY|||||||0.0679|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0679
71707065|NCT01557244|142931797|SUPERIORITY|||||||0.1233|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.1233
71707066|NCT01557244|142931797|SUPERIORITY|||||||0.0019|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline bladder compliance and baseline weight.||||0.0019
71707067|NCT01557244|142931797|OTHER||Difference in LS Mean|-4.96|||||TWO_SIDED|95.0|-14.81|4.89||||||||4.89|-14.81|
71707068|NCT01557244|142931797|OTHER||Difference in LS Mean|-5.95|||||TWO_SIDED|95.0|-15.85|3.95||||||||3.95|-15.85|
71707069|NCT01557244|142931798|SUPERIORITY|||||||0.0116|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0116
71707070|NCT01557244|142931798|SUPERIORITY|||||||0.0765|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0765
71707071|NCT01557244|142931798|SUPERIORITY|||||||0.0061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions per 24 hours and baseline weight.||||0.0061
71764911|NCT02744040|143032047|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
71764912|NCT02744040|143032047|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
71654364|NCT02508259|142826393|EQUIVALENCE|In this analysis, the child-specific RBQ score was tested for equivalence before and 6-weeks after suramin treatment.|Mean Difference (Net)|-3.2|STANDARD_DEVIATION|5.8||0.28|TWO_SIDED|95.0|-10.4|4.0|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.||4.0|-10.4|0.28
71654365|NCT00710749|142826400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44||95.0|||||Wilcoxon signed rank test|||||||0.44
71654366|NCT00710749|142826400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
71654367|NCT00710749|142826400|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon signed rank test|||||||<0.0001
71654368|NCT05626803|142826415|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654369|NCT05626803|142826415|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654370|NCT05626803|142826415|SUPERIORITY|||||||0.0003|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0003
71654371|NCT05626803|142826417|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654372|NCT05626803|142826417|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654373|NCT05626803|142826417|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654374|NCT05626803|142826419|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654375|NCT05626803|142826419|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654376|NCT05626803|142826419|SUPERIORITY|||||||0.0017|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0017
71654377|NCT05626803|142826421|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654378|NCT05626803|142826421|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654379|NCT05626803|142826421|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654380|NCT05626803|142826423|SUPERIORITY|||||||0.0059|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0059
71654381|NCT05626803|142826423|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
71654382|NCT05626803|142826423|SUPERIORITY|||||||0.1899|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.1899
71654383|NCT05626803|142826425|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654384|NCT05626803|142826425|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||<.0001
71654385|NCT05626803|142826425|SUPERIORITY|||||||0.002|||||||ANCOVA|Computed by using ANCOVA model with log transformed data as response variable and treatment as a fixed factor and baseline value as covariate.||||||0.0020
71654386|NCT04843566|142826446|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
71654387|NCT04843566|142826446|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
71654388|NCT04843566|142826446|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
71654389|NCT04843566|142826447|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Immediately following biopsy - Pain||||0.002
71654390|NCT04843566|142826447|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Immediately following biopsy - Discomfort||||0.05
71654391|NCT04843566|142826447|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||7-day post biopsy - Pain||||<0.0001
71654392|NCT04843566|142826447|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||7-day post biopsy - Discomfort||||0.07
71654393|NCT04843566|142826448|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71654394|NCT04843566|142826449|SUPERIORITY|||||||0.59|||||||Chi-squared|||Gleason grade \>=2||||0.59
71764913|NCT02744040|143032047|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||<0.0001
71764914|NCT02744040|143032047|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
71826323|NCT01543685|143157117|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|312.7|STANDARD_ERROR_OF_MEAN|130.4||0.017|TWO_SIDED|95.0|56.6|568.9|||ANCOVA|||||568.9|56.6|0.017
71826324|NCT01543685|143157117|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|211.6|STANDARD_ERROR_OF_MEAN|129.6||0.103|TWO_SIDED|95.0|-43.1|466.2|||ANCOVA|||||466.2|-43.1|0.103
71764915|NCT02744040|143032047|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
71764916|NCT02744040|143032047|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in integrated HIV DNA was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for integrated HIV DNA.||||>0.05
71764917|NCT02744040|143032048|OTHER|||||||0.057||||||Multiple hypothesis testing was performed using Tukey's HSD procedure.|Mixed Effects Models|||TILDA stimulation reservoir measure at the time of ART initiation in each of the three EDDI groups||||0.057
71764918|NCT02744040|143032049|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.01||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.010
71764919|NCT02744040|143032049|OTHER|Tukey's Honest Significant Difference (HSD) test|||||<|0.0001||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||<0.0001
71764920|NCT02744040|143032049|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 1|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
71826325|NCT01543685|143157118|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|||||||0.013
71826326|NCT01543685|143157118|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
71826327|NCT01543685|143157118|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||t-test, 2 sided|||||||0.211
71826328|NCT01543685|143157118|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||t-test, 2 sided|||||||0.098
71654395|NCT04843566|142826450|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Infection||||0.04
71826329|NCT01543685|143157119|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71654396|NCT04843566|142826450|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Urinary retention||||0.30
71654397|NCT04843566|142826450|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Bleeding requiring intervention||||0.31
71654398|NCT02054130|142826553|SUPERIORITY||Rate ratio|0.38|||<|0.001|TWO_SIDED|95.0|0.23|0.63|||Negative binomial regression|||||0.63|0.23|<0.001
71654399|NCT02054130|142826553|SUPERIORITY||Rate ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Negative binomial regression|||||0.51|0.16|<0.001
71654400|NCT02054130|142826553|SUPERIORITY||Rate ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.58|||Negative bnomial regression|||||0.58|0.20|<0.001
71654401|NCT00094458|142826575|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
71654402|NCT00094458|142826575|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.006
71654403|NCT00094458|142826575|SUPERIORITY_OR_OTHER|||||||0.022|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.022
71654404|NCT00094458|142826576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||<0.001
71826330|NCT01543685|143157119|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71826331|NCT01543685|143157119|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
71826332|NCT01543685|143157119|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
71654405|NCT00094458|142826576|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.023
71707072|NCT01557244|142931798|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.16|0.97||||||||0.97|-1.16|
71654406|NCT00094458|142826576|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline||||||0.055
71654407|NCT00834652|142826584|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71654408|NCT02312713|142826594|SUPERIORITY||Mean Difference (Final Values)|-3.36||||0.06|TWO_SIDED|95.0|-6.84|0.12|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.12|-6.84|0.06
71654409|NCT02312713|142826594|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.39|TWO_SIDED|95.0|-5.26|2.08|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||2.08|-5.26|0.39
71654410|NCT02312713|142826594|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.14|TWO_SIDED|95.0|-6.24|0.85|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.85|-6.24|0.14
71654411|NCT02312713|142826594|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.17|TWO_SIDED|95.0|-6.37|1.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||1.11|-6.37|0.17
71654412|NCT02312713|142826594|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|0.67||||0.65|TWO_SIDED|95.0|-2.23|3.56|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.56|-2.23|0.65
71654413|NCT02312713|142826594|NON_INFERIORITY|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|-1.04||||0.51|TWO_SIDED|95.0|-4.13|2.05|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.05|-4.13|0.51
71654414|NCT02312713|142826595|SUPERIORITY||Median Difference (Final Values)|0.56||||0.01|TWO_SIDED|95.0|0.15|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.98|0.15|0.01
71654415|NCT02312713|142826595|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.28|TWO_SIDED|95.0|-0.19|0.65|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.65|-0.19|0.28
71654416|NCT02312713|142826595|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.75|TWO_SIDED|95.0|-0.35|0.49|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.49|-0.35|0.75
71654417|NCT02312713|142826595|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.22|TWO_SIDED|95.0|-0.16|0.7|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.7|-0.16|0.22
71654418|NCT02312713|142826595|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.84|-0.16|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||-0.16|-0.84|0.00
71654419|NCT02312713|142826595|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.04||||0.83|TWO_SIDED|95.0|-0.31|0.39|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.39|-0.31|0.83
71654420|NCT02312713|142826596|SUPERIORITY||Mean Difference (Final Values)|7.75||||0.04|TWO_SIDED|95.0|0.43|15.07|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.||15.07|0.43|0.04
71654421|NCT02312713|142826596|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.78|TWO_SIDED|95.0|-6.59|8.82|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.||8.82|-6.59|0.78
71654422|NCT02312713|142826596|SUPERIORITY||Mean Difference (Final Values)|4.88||||0.2|TWO_SIDED|95.0|-2.56|12.33|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.||12.33|-2.56|0.20
71654423|NCT02312713|142826596|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.78|TWO_SIDED|95.0|-6.74|8.99|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.||8.99|-6.74|.78
71654424|NCT02312713|142826596|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-2.86||||0.35|TWO_SIDED|95.0|-8.94|3.21|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.||3.21|-8.94|0.35
71654425|NCT02312713|142826596|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-6.4|6.42|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.||6.42|-6.40|1.00
71654426|NCT02312713|142826597|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.19|TWO_SIDED|95.0|-1.56|0.3|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.||0.30|-1.56|0.19
71654427|NCT02312713|142826597|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.89|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.||0.98|-0.89|0.93
71826333|NCT01543685|143157120|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71654428|NCT02312713|142826597|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.97|TWO_SIDED|95.0|-0.97|0.93|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.||0.93|-0.97|0.97
71654429|NCT02312713|142826597|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.93|TWO_SIDED|95.0|-0.91|1.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time||1|-0.91|0.93
71654430|NCT02312713|142826597|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.61||||0.12|TWO_SIDED|95.0|-0.16|1.38|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.||1.38|-0.16|0.12
71654431|NCT02312713|142826597|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.78|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.||0.77|-0.78|1.00
71654432|NCT02312713|142826598|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.63|TWO_SIDED|95.0|-1.55|0.94|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.||.94|-1.55|0.63
71654433|NCT02312713|142826598|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.37|TWO_SIDED|95.0|-1.58|0.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.||0.6|-1.58|0.37
71654434|NCT02312713|142826598|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.62|TWO_SIDED|95.0|-0.95|1.59|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.||1.59|-0.95|0.62
71654435|NCT02312713|142826598|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.67|TWO_SIDED|95.0|-0.87|1.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.||1.35|-0.87|0.67
71654436|NCT02312713|142826598|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.63||||0.23|TWO_SIDED|95.0|-0.4|1.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.||1.66|-0.40|0.23
71654437|NCT02312713|142826598|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.74||||0.11|TWO_SIDED|95.0|-0.17|1.64|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.||1.64|-0.17|0.11
71654438|NCT02312713|142826599|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.52|TWO_SIDED|95.0|-1.58|0.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.||0.8|-1.58|0.52
71654439|NCT02312713|142826599|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.||0.85|-1.86|0.46
71654440|NCT02312713|142826599|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.3|TWO_SIDED|95.0|-1.85|0.58|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.||0.58|-1.85|0.3
71654441|NCT02312713|142826599|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.08|TWO_SIDED|95.0|-2.61|0.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.||0.16|-2.61|0.08
71654442|NCT02312713|142826599|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.24||||0.63|TWO_SIDED|95.0|-1.23|0.74|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.||0.74|-1.23|0.63
71654443|NCT02312713|142826599|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.72||||0.21|TWO_SIDED|95.0|-1.85|0.41|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.||0.41|-1.85|0.21
71654444|NCT02312713|142826600|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.05|TWO_SIDED|95.0|-1.59|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.02|-1.59|0.05
71654445|NCT02312713|142826600|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.05|TWO_SIDED|95.0|-1.82|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.02|-1.82|0.05
71654446|NCT02312713|142826600|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.19|TWO_SIDED|95.0|-1.37|0.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.27|-1.37|0.19
71707073|NCT01557244|142931798|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.74|1.31||||||||1.31|-0.74|
71826334|NCT01543685|143157120|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71826335|NCT01543685|143157120|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71826336|NCT01543685|143157120|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71707074|NCT01557244|142931799|SUPERIORITY|||||||0.0787|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0787
71707075|NCT01557244|142931799|SUPERIORITY|||||||0.0727|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0727
71707076|NCT01557244|142931799|SUPERIORITY|||||||0.0666|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of catheterizations per 24 hours and baseline weight.||||0.0666
71707077|NCT01557244|142931799|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.45|0.54||||||||0.54|-0.45|
71707078|NCT01557244|142931799|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.49|0.52||||||||0.52|-0.49|
71707079|NCT01557244|142931800|SUPERIORITY|||||||0.0111|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0111
71707080|NCT01557244|142931800|SUPERIORITY|||||||0.0171|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0171
71707081|NCT01557244|142931800|SUPERIORITY|||||||0.0028|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of micturitions and catheterizations combined per 24 hours and baseline weight.||||0.0028
71707082|NCT01557244|142931800|OTHER||Difference in LS Mean|0.14|||||TWO_SIDED|95.0|-0.53|0.82||||||||0.82|-0.53|
71707083|NCT01557244|142931800|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.54|0.84||||||||0.84|-0.54|
71707084|NCT01557244|142931801|SUPERIORITY|||||||0.0496|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0496
71707085|NCT01557244|142931801|SUPERIORITY|||||||0.0002|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||0.0002
71707086|NCT01557244|142931801|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of incontinence episodes per 24 hours and baseline weight.||||<.0001
71707087|NCT01557244|142931801|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.09|1.19||||||||1.19|-0.09|
71707088|NCT01557244|142931801|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.52|0.77||||||||0.77|-0.52|
71707089|NCT01557244|142931802|SUPERIORITY|||||||0.0298|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.0298
71707090|NCT01557244|142931802|SUPERIORITY|||||||0.1417|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.1417
71707091|NCT01557244|142931802|SUPERIORITY|||||||0.6219|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline number of urgency episodes per 24 hours and baseline weight.||||0.6219
71707092|NCT01557244|142931802|OTHER||Difference in LS Mean|-0.48|||||TWO_SIDED|95.0|-1.28|0.32||||||||0.32|-1.28|
71707093|NCT01557244|142931802|OTHER||Difference in LS Mean|-0.36|||||TWO_SIDED|95.0|-1.24|0.52||||||||0.52|-1.24|
71707094|NCT01557244|142931803|SUPERIORITY|||||||0.7986|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7986
71707095|NCT01557244|142931803|SUPERIORITY|||||||0.2313|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.2313
71707096|NCT01557244|142931803|SUPERIORITY|||||||0.7571|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition and baseline weight.||||0.7571
71707097|NCT01557244|142931803|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-42.11|42.0||||||||42.00|-42.11|
71707098|NCT01557244|142931803|OTHER||Difference in LS Mean|15.07|||||TWO_SIDED|95.0|-26.5|56.63||||||||56.63|-26.50|
71707099|NCT01557244|142931804|SUPERIORITY|||||||0.061|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0610
71707100|NCT01557244|142931804|SUPERIORITY|||||||0.0048|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0048
71707101|NCT01557244|142931804|SUPERIORITY|||||||0.01|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per catheterization and baseline weight.||||0.0100
71707102|NCT01557244|142931804|OTHER||Difference in LS Mean|-16.43|||||TWO_SIDED|95.0|-63.14|30.29||||||||30.29|-63.14|
71707103|NCT01557244|142931804|OTHER||Difference in LS Mean|1.28|||||TWO_SIDED|95.0|-46.0|48.57||||||||48.57|-46.00|
71707104|NCT01557244|142931805|SUPERIORITY|||||||0.2246|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.2246
71707105|NCT01557244|142931805|SUPERIORITY|||||||0.0003|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0003
71707106|NCT01557244|142931805|SUPERIORITY|||||||0.0161|||||||ANCOVA|||P-value was calculated for change from Baseline at Week 12, based on an ANCOVA model with terms for treatment group, baseline mean volume voided per micturition or catheterization and baseline weight.||||0.0161
71707107|NCT01557244|142931805|OTHER||Difference in LS Mean|-18.24|||||TWO_SIDED|95.0|-61.0|24.53||||||||24.53|-61.00|
71707108|NCT01557244|142931805|OTHER||Difference in LS Mean|18.86|||||TWO_SIDED|95.0|-22.93|60.65||||||||60.65|-22.93|
71764921|NCT02744040|143032049|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
71764922|NCT02744040|143032049|OTHER|Tukey's Honest Significant Difference (HSD) test||||||0.052||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||0.052
71764923|NCT02744040|143032049|OTHER|Tukey's Honest Significant Difference (HSD) test|||||>|0.05||||||Pair-Wise comparison of Slope 2|Tukey's Honest Significant Difference (H|||The decay in TILDA stimulation was modeled from the time of ART initiation in each of the three EDDI groups until the end of follow-up. The decay was analyzed on the log10 scale with a mixed-effects model to account for correlation between measurements from the same individual. We used a piecewise linear function to model the decay, where the number of linear segments was fixed at 2 (two-phase segmentation model) for TILDA Stimulation.||||>0.05
71764924|NCT00096356|143032057|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.03||0.1815|TWO_SIDED|95.0|-3.39|0.64||The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.|Mixed Models Analysis||This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.||0.64|-3.39|0.1815
71764925|NCT00096356|143032058|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|2.31||0.3903|TWO_SIDED|95.0|-2.56|6.53||0.05 significance level; no multiple comparison adjustment|Mixed Models Analysis||This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.|Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates||6.53|-2.56|.3903
71764926|NCT00096356|143032059|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.31||0.6014|TWO_SIDED|95.0|-3.25|1.88||0.05 significance level, unadjusted for multiple comparisons|Mixed Models Analysis||This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates||1.88|-3.25|.6014
71764927|NCT01809639|143032060|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||.42
71764928|NCT03698591|143032066|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
71764929|NCT03698591|143032066|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distancing performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
71764930|NCT03698591|143032066|OTHER||t-statistic|-1.656||||0.108|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distancing performance between study periods 1 and 2. The null hypothesis was that distancing performance would not differ by study period.||||.108
71826337|NCT01543685|143157121|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71826338|NCT01543685|143157121|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
71654447|NCT02312713|142826600|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.06|TWO_SIDED|95.0|-1.83|0.05|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.05|-1.83|0.06
71764931|NCT03698591|143032066|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
71764932|NCT03698591|143032067|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distancing self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
71764933|NCT03698591|143032067|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
71764934|NCT03698591|143032067|OTHER||t-statistic|2.694||||0.012|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test a potential effect of study period on distancing effort.||||.012
71826339|NCT01543685|143157121|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||t-test, 2 sided|||||||0.146
71826340|NCT01543685|143157121|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|||||||0.071
71826341|NCT01543685|143157122|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71826342|NCT01543685|143157122|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
71826343|NCT01543685|143157122|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.010
71826344|NCT01543685|143157122|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
71826345|NCT01543685|143157123|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71826346|NCT01543685|143157123|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
71886569|NCT05227690|143293410|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.3933|TWO_SIDED|95.0|0.0|0.1|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 3-- Emraclidine 10 mg versus Placebo||0.1|0.0|=0.3933
71886570|NCT05227690|143293410|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.7366|TWO_SIDED|95.0|0.0|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 30 mg - Placebo|Week 6-- Emraclidine 30 mg versus Placebo||0.0|0.0|=0.7366
71886571|NCT05227690|143293410|SUPERIORITY|Least-squares mean difference from Placebo and CIs were estimated using a mixed effects repeated measures model with fixed effects for treatment group, geographic region, visit, and treatment-by-visit interaction and Baseline value as a covariate. Participant was included as a random effect. An unstructured covariance structure was used.|LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.4639|TWO_SIDED|95.0|-0.1|0.0|||Mixed Model for Repeated Measures (MMRM)||Emraclidine 10 mg - Placebo|Week 6-- Emraclidine 10 mg versus Placebo||0.0|-0.1|=0.4639
71707109|NCT01644331|142931875|SUPERIORITY_OR_OTHER|||||||0.315|||||||Chi-squared|||||||0.315
71707110|NCT01644331|142931876|SUPERIORITY_OR_OTHER||Slope|0.19||||0.021|TWO_SIDED|95.0|0.03|0.34|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.34|0.03|0.021
71707111|NCT01644331|142931877|SUPERIORITY_OR_OTHER||Slope|0.99||||0.43|TWO_SIDED|95.0|-1.47|3.44|||Mixed Models Analysis|||This a repeated measure analysis so all rows (visits) are taken into account.||3.44|-1.47|0.430
71707112|NCT01644331|142931878|SUPERIORITY_OR_OTHER||Slope|-493.21||||0.157|TWO_SIDED|95.0|-1176.96|190.55|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||190.55|-1176.96|0.157
71707113|NCT01644331|142931879|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||This is a repeated measures analysis so all rows (visits) are taken into account.||||0.206
71707114|NCT01644331|142931880|SUPERIORITY_OR_OTHER||Kaplan Meier|0.98||||0.334|TWO_SIDED|95.0|0.96|0.99|||Log Rank|||||0.99|0.96|0.334
71707115|NCT01644331|142931881|SUPERIORITY_OR_OTHER|||||||0.148|||||||Chi-squared|||||||0.148
71707116|NCT01644331|142931882|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||||||0.334
71707117|NCT01644331|142931883|SUPERIORITY_OR_OTHER||Slope|-0.67||||0.241|TWO_SIDED|95.0|-1.79|0.45|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.45|-1.79|0.241
71707118|NCT01644331|142931884|SUPERIORITY_OR_OTHER||Slope|0.28||||0.303|TWO_SIDED|95.0|-0.26|0.82|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.||0.82|-0.26|0.303
71707119|NCT01644331|142931885|SUPERIORITY_OR_OTHER|||||||0.471||||||24 hours|Chi-squared|||||||0.471
71707120|NCT01644331|142931885|SUPERIORITY_OR_OTHER|||||||0.585||||||48 hrs|Chi-squared|||||||0.585
71707121|NCT01644331|142931885|SUPERIORITY_OR_OTHER|||||||0.12||||||72 hrs|Chi-squared|||||||0.120
71707122|NCT01644331|142931886|SUPERIORITY_OR_OTHER|||||||0.037|||||||Chi-squared|||||||0.037
71707123|NCT01644331|142931887|SUPERIORITY_OR_OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
71707124|NCT01644331|142931888|SUPERIORITY_OR_OTHER||Kaplan Meier|0.26||||0.709|TWO_SIDED|95.0|0.21|0.32|||Log Rank|||||0.32|0.21|0.709
71707125|NCT02327143|142931891|SUPERIORITY_OR_OTHER||Ratio of geometric least squares|0.448|||||TWO_SIDED|90.0|0.395|0.508|||||Absolute bioavailability of LY2835219 following the administration of 200 mg LY2835219 (oral) with 0.4 mg \[13C8\]-LY2835219 (IV).|||0.508|0.395|
71707126|NCT02070380|142931905|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|47.6|||<|0.0001|TWO_SIDED|95.0|34.5|60.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment."||60.7|34.5|<0.0001
71707127|NCT02070380|142931905|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|7.3||||0.1295|TWO_SIDED|95.0|-2.0|16.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||16.5|-2.0|0.1295
71707128|NCT02070380|142931905|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|79.0|||<|0.0001|TWO_SIDED|95.0|67.1|91.0||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment"||91.0|67.1|<0.0001
71707129|NCT02070380|142931905|SUPERIORITY_OR_OTHER||Percentage MH better minus DM better|-2.1||||0.7503|TWO_SIDED|95.0|-15.0|10.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||10.7|-15.0|0.7503
71707130|NCT02070380|142931905|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|66.1|||<|0.0001|TWO_SIDED|95.0|52.8|79.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment"||79.5|52.8|<0.0001
71707131|NCT02070380|142931905|SUPERIORITY_OR_OTHER||∆Percentage MH better minus DM better|-2.1||||0.7297|TWO_SIDED|95.0|-13.8|9.6||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman's general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."||9.6|-13.8|0.7297
71707132|NCT02070380|142931906|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707133|NCT02070380|142931906|SUPERIORITY_OR_OTHER|||||||0.8238||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment."||||0.8238
71707134|NCT02070380|142931906|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707135|NCT02070380|142931906|SUPERIORITY_OR_OTHER|||||||0.4597||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.4597
71707136|NCT02070380|142931906|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707137|NCT02070380|142931906|SUPERIORITY_OR_OTHER|||||||0.8145||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."||||0.8145
71707138|NCT02070380|142931907|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0020
71707139|NCT02070380|142931907|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
71707140|NCT02070380|142931907|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.0001
71707141|NCT02070380|142931907|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||1.0000
71707142|NCT02070380|142931907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707143|NCT02070380|142931907|SUPERIORITY_OR_OTHER|||||||0.5811|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."||||0.5811
71707144|NCT02070380|142931908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707145|NCT02070380|142931908|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
71707146|NCT02070380|142931908|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707147|NCT02070380|142931908|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
71707148|NCT02070380|142931908|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||0.0023
71826347|NCT01543685|143157123|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
71654448|NCT02312713|142826600|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.23||||0.49|TWO_SIDED|95.0|-0.43|0.89|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||0.89|-0.43|0.49
71654449|NCT02312713|142826600|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.77|0.78|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.78|-0.77|0.99
71654450|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.57||||0.36|TWO_SIDED|95.0|-1.77|4.92|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.||4.92|-1.77|0.36
71654451|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.51||||0.17|TWO_SIDED|95.0|-1.11|6.14|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.||6.14|-1.11|0.17
71654452|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.94||||0.06|TWO_SIDED|95.0|-0.19|8.06|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.||8.06|-0.19|0.06
71654453|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.14|TWO_SIDED|95.0|-1.08|7.79|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.||7.79|-1.08|0.14
71654454|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|2.37||||0.25|TWO_SIDED|95.0|-1.67|6.4|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.||6.4|-1.67|0.25
71654455|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.7|TWO_SIDED|95.0|-3.48|5.18|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.||5.18|-3.48|0.70
71654456|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-1.32||||0.4|TWO_SIDED|95.0|-4.43|1.79|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.||1.79|-4.43|0.40
71654457|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.84|TWO_SIDED|95.0|-2.93|3.59|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.||3.59|-2.93|0.84
71654458|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|2.11||||0.28|TWO_SIDED|95.0|-1.73|5.94|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.||5.94|-1.73|0.28
71654459|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|2.79||||0.17|TWO_SIDED|95.0|-1.2|6.77|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.||6.77|-1.2|0.17
71654460|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.43||||0.07|TWO_SIDED|95.0|-0.32|7.18|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.||7.18|-0.32|0.07
71707149|NCT02070380|142931908|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."||||1.0000
71707150|NCT02070380|142931909|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707151|NCT02070380|142931909|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus post-dose paired global assessment."||||1.0000
71826348|NCT01543685|143157123|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
71654461|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.22|TWO_SIDED|95.0|-1.44|6.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.||6.34|-1.44|0.22
71707152|NCT02070380|142931909|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71707153|NCT02070380|142931909|SUPERIORITY_OR_OTHER|||||||0.7503|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.7503
71826349|NCT01543685|143157124|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71826350|NCT01543685|143157124|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.020
71826351|NCT01543685|143157124|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
71707154|NCT02070380|142931909|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||<0.0001
71764935|NCT03698591|143032067|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
71764936|NCT03698591|143032067|OTHER||F-statistic|7.162||||0.013|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distancing effort. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.013
71764937|NCT03698591|143032068|OTHER||F-statistic|6.155||||0.019|TWO_SIDED|||||P-value corresponds to 3 way interaction. A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.019
71764938|NCT03698591|143032068|OTHER||F-statistic|5.911||||0.021|TWO_SIDED|||||P-value corresponds to two-way interaction. A priori significance threshold of p \< .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distraction performance would not differ by study period. Within-subjects factors included task condition and study period.||||.021
71764939|NCT03698591|143032068|OTHER||t-statistic|1.282||||0.21|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distraction performance between study periods 1 and 2. The null hypothesis was that distraction performance would not differ by study period.||||.210
71764940|NCT03698591|143032068|OTHER||F-statistic|0.004||||0.948|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.948
71654462|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.21||||0.92|TWO_SIDED|95.0|-4.47|4.06|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.||4.06|-4.47|.92
71707155|NCT02070380|142931909|SUPERIORITY_OR_OTHER|||||||0.5983|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."||||0.5983
71707156|NCT02070380|142931910|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||<0.0001
71707157|NCT02070380|142931910|SUPERIORITY_OR_OTHER|||||||0.6898|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.6898
71707158|NCT02070380|142931910|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect.||||||<0.0001
71707159|NCT02070380|142931910|SUPERIORITY_OR_OTHER|||||||0.1156|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.1156
71764941|NCT03698591|143032069|OTHER||F-statistic|0.031||||0.862|TWO_SIDED|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p \< .05.|ANOVA|||The null hypothesis was that distraction self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.||||.862
71826352|NCT01543685|143157124|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
71654463|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.55||||0.82|TWO_SIDED|95.0|-4.15|5.24|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.||5.24|-4.15|.82
71654464|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.71||||0.17|TWO_SIDED|95.0|-1.59|9.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.||9|-1.59|0.17
71707160|NCT02070380|142931910|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71707161|NCT02070380|142931910|SUPERIORITY_OR_OTHER|||||||0.7726|||||||Mixed Models Analysis|||||||0.7726
71707162|NCT02070380|142931911|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0002
71707163|NCT02070380|142931911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71707164|NCT02070380|142931911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71707165|NCT02070380|142931911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71654465|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|6.01||||0.04|TWO_SIDED|95.0|0.29|11.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.||11.74|0.29|0.04
71707166|NCT02070380|142931911|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||<0.0001
71654466|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.91||||0.14|TWO_SIDED|95.0|-1.28|9.1|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.||9.1|-1.28|0.14
71654467|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.05|TWO_SIDED|95.0|-0.1|11.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.||11.03|-0.1|0.05
71654468|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.86|TWO_SIDED|95.0|-3.29|3.96|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.||3.96|-3.29|.86
71654469|NCT02312713|142826601|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.59||||0.15|TWO_SIDED|95.0|-0.96|6.13|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.||6.13|-0.96|0.15
71654470|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.11|TWO_SIDED|95.0|-0.85|8.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.||8.11|-0.85|0.11
71654471|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|7.74||||0|TWO_SIDED|95.0|3.39|12.08|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.||12.08|3.39|0
71654472|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|3.29||||0.14|TWO_SIDED|95.0|-1.08|7.67|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.||7.67|-1.08|0.14
71654473|NCT02312713|142826601|SUPERIORITY||Mean Difference (Final Values)|5.15||||0.02|TWO_SIDED|95.0|0.92|9.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.||9.37|0.92|0.02
71654474|NCT02312713|142826602|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.02|TWO_SIDED|95.0|-4.67|-0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.5|-4.67|0.02
71654475|NCT02312713|142826602|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.33|TWO_SIDED|95.0|-3.22|1.09|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||1.09|-3.22|0.33
71654476|NCT02312713|142826602|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.52|1.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.74|-2.52|0.72
71654477|NCT02312713|142826602|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.56|TWO_SIDED|95.0|-1.56|2.86|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||2.86|-1.56|0.56
71654478|NCT02312713|142826602|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.19||||0.01|TWO_SIDED|95.0|0.48|3.9|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.9|0.48|0.01
71654479|NCT02312713|142826602|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.71||||0.06|TWO_SIDED|95.0|-0.1|3.52|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||3.52|-0.1|0.06
71654480|NCT02312713|142826603|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.03|TWO_SIDED|95.0|-4.67|-0.26|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||-0.26|-4.67|0.03
71654481|NCT02312713|142826603|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.01|TWO_SIDED|95.0|-4.31|-0.55|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||-0.55|-4.31|0.01
71654482|NCT02312713|142826603|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.39|TWO_SIDED|95.0|-3.24|1.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||1.27|-3.24|0.39
71654483|NCT02312713|142826603|SUPERIORITY||Mean Difference (Final Values)|-1.65||||0.1|TWO_SIDED|95.0|-3.58|0.29|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.29|-3.58|0.1
71654484|NCT02312713|142826603|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.48||||0.11|TWO_SIDED|95.0|-0.33|3.29|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||3.29|-0.33|0.11
71654485|NCT02312713|142826603|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.33|TWO_SIDED|95.0|-0.8|2.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||2.37|-0.8|0.33
71764942|NCT03698591|143032069|OTHER||F-statistic|4.04||||0.054|TWO_SIDED|||||P-value corresponds to the main effect of study period. A priori threshold of p \< .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.||||.054
71654486|NCT02312713|142826604|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.06|TWO_SIDED|95.0|-1.62|0.04|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||0.04|-1.62|0.06
71654487|NCT02312713|142826604|SUPERIORITY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.77|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||0.77|-0.77|1.00
71654488|NCT02312713|142826604|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||0.41|-1.29|0.31
71654489|NCT02312713|142826604|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.58|TWO_SIDED|95.0|-1.01|0.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||0.57|-1.01|0.58
71654490|NCT02312713|142826604|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.35||||0.32|TWO_SIDED|95.0|-0.33|1.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||1.03|-0.33|0.32
71654491|NCT02312713|142826604|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.22||||0.51|TWO_SIDED|95.0|-0.86|0.43|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||0.43|-0.86|0.51
71654492|NCT02312713|142826605|SUPERIORITY||Mean Difference (Final Values)|6.95||||0.48|TWO_SIDED|95.0|-12.31|26.22|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.||26.22|-12.31|0.48
71654493|NCT02312713|142826605|SUPERIORITY||Mean Difference (Final Values)|7.11||||0.41|TWO_SIDED|95.0|-9.69|23.91|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.||23.91|-9.69|0.41
71654494|NCT02312713|142826605|SUPERIORITY||Mean Difference (Final Values)|-6.82||||0.5|TWO_SIDED|95.0|-26.55|12.91|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.||12.91|-26.55|0.50
71654495|NCT02312713|142826605|SUPERIORITY||Mean Difference (Final Values)|7.02||||0.43|TWO_SIDED|95.0|-10.31|24.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.||24.35|-10.31|0.43
71654496|NCT02312713|142826605|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-13.77||||0.09|TWO_SIDED|95.0|-29.73|2.19|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.||2.19|-29.73|0.09
71654497|NCT02312713|142826605|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.09||||0.99|TWO_SIDED|95.0|-14.41|14.23|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.||14.23|-14.41|0.99
71654498|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.36||||0.04|TWO_SIDED|95.0|0.05|2.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercises||2.66|0.05|0.04
71654499|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.09|TWO_SIDED|95.0|-0.18|2.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.||2.6|-0.18|0.09
71654500|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.22|TWO_SIDED|95.0|-0.49|2.19|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.||2.19|-0.49|0.22
71654501|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.06|TWO_SIDED|95.0|-0.08|2.78|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.||2.78|-0.08|0.06
71654502|NCT02312713|142826606|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.51||||0.36|TWO_SIDED|95.0|-1.6|0.58|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.||0.58|-1.6|0.36
71654503|NCT02312713|142826606|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.14||||0.81|TWO_SIDED|95.0|-1.03|1.31|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.||1.31|-1.03|0.81
71654504|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.85||||0|TWO_SIDED|95.0|0.67|3.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.||3.03|0.67|0.00
71764943|NCT03698591|143032069|OTHER||t-statistic|0.828||||0.415|TWO_SIDED|||||A priori significance threshold of p \< .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test the effect of study period on distraction effort.||||.415
71826353|NCT02931396|143157125|SUPERIORITY||Mean Difference (Net)|2.3||||0.768|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.768
71826354|NCT02931396|143157126|SUPERIORITY||Mean Difference (Net)|25.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
71707167|NCT02070380|142931911|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.0003
71707168|NCT01507103|142931912|SUPERIORITY_OR_OTHER||Effect estimate|-0.04||||0.794|TWO_SIDED|95.0|-0.72|0.65||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.65|-0.72|0.794
71707169|NCT01507103|142931912|SUPERIORITY_OR_OTHER||Effect estimate|-0.2||||0.794|TWO_SIDED|95.0|-0.82|0.43||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.43|-0.82|0.794
71707170|NCT01507103|142931912|SUPERIORITY_OR_OTHER||Effect estimate|0.16||||0.794|TWO_SIDED|95.0|-0.49|0.82||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.82|-0.49|0.794
71654505|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.62||||0|TWO_SIDED|95.0|0.55|2.68|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.||2.68|0.55|0.00
71654506|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.03|TWO_SIDED|95.0|0.16|2.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.||2.57|0.16|0.03
71654507|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|2.07||||0|TWO_SIDED|95.0|0.98|3.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.||3.16|0.98|0.00
71654508|NCT02312713|142826606|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.48||||0.33|TWO_SIDED|95.0|-1.46|0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.||0.5|-1.46|0.33
71654509|NCT02312713|142826606|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.45||||0.32|TWO_SIDED|95.0|-0.44|1.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.||1.34|-0.44|0.32
71654510|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.21|TWO_SIDED|95.0|-0.61|2.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.||2.8|-0.61|0.21
71826355|NCT02931396|143157127|SUPERIORITY||Mean Difference (Net)|2.7||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
71826356|NCT01304147|143157150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|3.9|11.3|||Paired t-test, 2 sided|||within-subject crossover design||11.3|3.9|<0.001
71826357|NCT01278862|143157152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2423|||||||Fisher Exact|||null hypothesis no difference in color match||||0.2423
71654511|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|2.07||||0.04|TWO_SIDED|95.0|0.13|4.0|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.||4|0.13|0.04
71654512|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.15|3.62|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.||3.62|0.15|0.03
71654513|NCT02312713|142826606|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.05|TWO_SIDED|95.0|0.01|3.97|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.||3.97|0.01|0.05
71654514|NCT02312713|142826606|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.27|TWO_SIDED|95.0|-0.62|2.2|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.||2.2|-0.62|0.27
71654515|NCT02312713|142826606|NON_INFERIORITY|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.07||||0.93|TWO_SIDED|95.0|-1.69|1.54|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.||1.54|-1.69|0.93
71654516|NCT01553747|142826616|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
71654517|NCT01553747|142826616|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
71826358|NCT01278862|143157152|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in margin discoloration||||>0.999
71826359|NCT01278862|143157152|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in crown fracture||||>0.999
71654518|NCT01553747|142826617|SUPERIORITY|||||||0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.001
71654519|NCT01553747|142826617|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
71654520|NCT01490931|142826642|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value adjusted with Bonferroni corrections for multiple comparisons|t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654521|NCT01490931|142826646|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654522|NCT01490931|142826647|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654523|NCT01490931|142826648|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654524|NCT01490931|142826649|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654525|NCT01490931|142826650|SUPERIORITY_OR_OTHER||||||<|1|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0001
71654526|NCT01490931|142826651|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654527|NCT01490931|142826652|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71654528|NCT01490931|142826653|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.||||<0.0001
71707171|NCT01507103|142931912|SUPERIORITY_OR_OTHER||Effect estimate|0.02||||0.654|TWO_SIDED|95.0|-0.52|0.57||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.57|-0.52|0.654
71707172|NCT01507103|142931912|SUPERIORITY_OR_OTHER||Effect estimate|-0.19||||0.654|TWO_SIDED|95.0|-0.69|0.31||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.31|-0.69|0.654
71707173|NCT01507103|142931912|SUPERIORITY_OR_OTHER||Effect estimate|0.21||||0.654|TWO_SIDED|95.0|-0.31|0.74||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B||0.74|-0.31|0.654
71707174|NCT01507103|142931913|SUPERIORITY_OR_OTHER||LS Means estimate|-0.03||||0.921|TWO_SIDED|95.0|-0.73|0.67|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.67|-0.73|0.921
71826360|NCT01278862|143157152|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in Proximal Contact - Mesial||||>0.999
71826361|NCT01278862|143157152|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in proximal contact - distal||||>0.999
71707175|NCT01507103|142931913|SUPERIORITY_OR_OTHER||LS Means estimate|-0.2||||0.921|TWO_SIDED|95.0|-0.83|0.44|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.44|-0.83|0.921
71707176|NCT01507103|142931913|SUPERIORITY_OR_OTHER||LS Means estimate|0.17||||0.921|TWO_SIDED|95.0|-0.5|0.83|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.83|-0.50|0.921
71707177|NCT01507103|142931913|SUPERIORITY_OR_OTHER||LS Means estimate|0.02||||0.89|TWO_SIDED|95.0|-0.54|0.58|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.58|-0.54|0.890
71707178|NCT01507103|142931913|SUPERIORITY_OR_OTHER||LS Means estimate|-0.19||||0.89|TWO_SIDED|95.0|-0.7|0.31|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.31|-0.70|0.890
71707179|NCT01507103|142931913|SUPERIORITY_OR_OTHER||LS Means estimate|0.21||||0.89|TWO_SIDED|95.0|-0.32|0.74|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.||0.74|-0.32|0.890
71707180|NCT04535362|142931973|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.63||0.93|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.93
71707181|NCT04535362|142931974|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.3||0.68|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.68
71707182|NCT04535362|142931976|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.51||0.37|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.37
71707183|NCT04535362|142931977|SUPERIORITY||Mean Difference (Net)|1.26|STANDARD_ERROR_OF_MEAN|0.98||0.2|TWO_SIDED||||||Mixed Models Analysis|||The fixed effects in the mixed models were infusion rate (2.5 minutes, 5 minutes and 10 minutes (placebo)), cigarette condition (menthol vs. non-menthol), and their interaction. We also controlled for order effects of cigarette condition by including session in the models Subject was a clustering factor and different variance-covariance structures were considered within each condition and subject. The best-fitting structure was selected based on Schwartz's Bayesian Criterion.||||0.20
71707184|NCT01104870|142932129|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.95
71707185|NCT01104870|142932129|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||Primary comparisons are between Dose Group 1 \& Dose Group 3 and Dose Group 1 \& Dose Group 2. The study is not powered to test for a difference between Dose Group 2 \& Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.||||0.27
71707186|NCT03093246|142932157|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
71707187|NCT03093246|142932158|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
71707188|NCT03093246|142932159|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Generalized Estimated Equations|||||||<0.05
71886572|NCT04033367|143293411|SUPERIORITY||Least square mean difference|-15.52|||<|0.001|TWO_SIDED|95.0|-24.13|-6.9||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||-6.90|-24.13|<0.001
71707189|NCT04641975|142932163|SUPERIORITY||LS Mean difference|2.22|STANDARD_ERROR_OF_MEAN|1.34||0.121|TWO_SIDED|90.0|-0.15|4.59|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with change from baseline at week 12 Last Observation Carried Forward (LOCF) as response, treatment group, sex and geographical region as fixed effects and the mean number of micturitions per 24 hours at baseline as covariate.||4.59|-0.15|0.121
71707190|NCT04641975|142932164|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
71707191|NCT04641975|142932164|SUPERIORITY||Mean Difference (Final Values)|-15.51|STANDARD_ERROR_OF_MEAN|18.91||0.43|TWO_SIDED|90.0|-49.47|18.46|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||18.46|-49.47|0.430
71707192|NCT04641975|142932165|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
71707193|NCT04641975|142932165|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|31.08||0.935|TWO_SIDED|90.0|-53.23|58.38|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||58.38|-53.23|0.935
71707194|NCT04641975|142932166|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.53||0.073|TWO_SIDED|90.0|-1.99|-0.1|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.10|-1.99|0.073
71707195|NCT04641975|142932166|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.45||0.044|TWO_SIDED|90.0|-1.8|-0.2|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean volume voided per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||-0.20|-1.80|0.044
71707196|NCT04641975|142932167|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
71707197|NCT04641975|142932167|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.91|TWO_SIDED|90.0|-0.74|0.64|||ANCOVA|||ANCOVA as performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime incontinence episodes per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||0.64|-0.74|0.910
71826362|NCT01278862|143157153|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in gingival index||||>0.999
71826363|NCT01278862|143157153|SUPERIORITY|||||||0.524|||||||Fisher Exact|||null hypothesis no difference in plaque index||||0.5240
71826364|NCT04520165|143157154|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
71826365|NCT04520165|143157156|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
71826366|NCT04520165|143157157|EQUIVALENCE|if p\<0.05 than the null hypothesis was considered as wrong and groups differed for the analysed parameter.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The baseline parameters in each group were compared with Mann-Whitney U test was performed.||||<0.05
71826367|NCT00798265|143157210|OTHER|||||||0.002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||0.0020
71826368|NCT00798265|143157210|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 1.|Spearman correlation (non-parametric)|||||||<.0001
71826369|NCT00798265|143157210|OTHER|||||||0.0002||||||The reported p-value is representative of the changes in HPV-16 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||0.0002
71826370|NCT00798265|143157210|OTHER||||||<|0.0001||||||The reported p-value is representative of the changes in HPV-18 at 7 months in Cohort 2.|Spearman correlation (non-parametric)|||||||<.0001
71826371|NCT04341298|143157217|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71826372|NCT04341298|143157218|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71826373|NCT04341298|143157219|SUPERIORITY|||||||0.66|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects with a pain score of 3 or less after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting mild or no symptoms after 2 hours and the type of device, across all strata.||||0.66
71707198|NCT04641975|142932168|SUPERIORITY||Mean Difference (Final Values)|2.48|STANDARD_ERROR_OF_MEAN|0.85||0.012|TWO_SIDED|90.0|0.97|3.99|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 without LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.99|0.97|0.012
71707199|NCT04641975|142932168|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|0.77||0.007|TWO_SIDED|90.0|1.1|3.82|||ANCOVA|||ANCOVA was performed with change from baseline at week 12 with LOCF as response, treatment group, sex and geographical region as fixed effects and the mean number of daytime micturitions per 24 hours at baseline as covariate. Statistically significant treatment difference at 0.10 level for mirabegron vs placebo.||3.82|1.10|0.007
71707200|NCT04641975|142932169|SUPERIORITY||Rate ratio|0.2||||0.105|TWO_SIDED|90.0|0.04|1.02|||Binomial regression|||Without LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.02|0.04|0.105
71707201|NCT04641975|142932169|SUPERIORITY||Rate ratio|0.22||||0.111|TWO_SIDED|90.0|0.05|1.05|||Binomial regression|||With LOCF: From a negative binomial regression model including treatment group, sex and region as factors and the log baseline rate of number of dry days (the log of the ratio of dry days at baseline and number of diary days at baseline) as covariate.||1.05|0.05|0.111
71707202|NCT05287685|142932208|OTHER|||||||0.29|||||||t-test, 2 sided|||Preliminary pre-post outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.29
71707203|NCT05287685|142932208|OTHER|||||||0.34|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.34
71707204|NCT05287685|142932208|SUPERIORITY|||||||0.02|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.02
71707205|NCT05287685|142932208|SUPERIORITY|||||||0.04|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.04
71707206|NCT05287685|142932209|OTHER|||||||0.88|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.88
71707207|NCT05287685|142932209|OTHER|||||||0.87|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.87
71707208|NCT05287685|142932209|SUPERIORITY|||||||0.1|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.10
71707209|NCT05287685|142932209|SUPERIORITY|||||||0.9|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.90
71707210|NCT05287685|142932210|EQUIVALENCE|Analysis to test whether groups had equivalent levels of satisfaction with treatment (defined as the groups not being significantly different at the level of p\<.05).||||||0.8|||||||t-test, 2 sided|||T-test analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups.||||.80
71707211|NCT05287685|142932211|OTHER|||||||0.35|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.35
71707212|NCT05287685|142932211|OTHER|||||||0.049|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.049
71707213|NCT05287685|142932211|SUPERIORITY|||||||0.45|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.45
71707214|NCT05287685|142932211|SUPERIORITY|||||||0.2|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.20
71707215|NCT05287685|142932212|OTHER|||||||0.006|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline (week 0) to posttest (week 8) scores.||||.006
71707216|NCT05287685|142932212|OTHER|||||||0.011|||||||t-test, 2 sided|||Preliminary outcome analysis for the open trial (n = 7). The analysis was a paired samples t-test comparing baseline(week 0) to follow-up (week 16) scores.||||.011
71707217|NCT05287685|142932212|SUPERIORITY|||||||0.22|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at posttest (Week 8) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.22
71707218|NCT05287685|142932212|SUPERIORITY|||||||0.25|||||||ANCOVA|||ANCOVA analysis for the pilot RCT, comparing the outcome variable at follow-up (Week 16) between the two groups, with pretest (baseline) scores, annual household income and household size (to approximate income-to-needs ratio), caregiver education, and child externalizing behavior as covariates.||||.25
71707219|NCT02777190|142932281|NON_INFERIORITY|Margin of 4 hours|Mean Difference (Final Values)|-1.7||||0.09|ONE_SIDED|97.5||6.7|||t-test, 1 sided|one-sided two-sample t-test with alpha=0.025|Difference calculated as oral minus vaginal|||6.7||0.09
71707220|NCT02777190|142932282|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71707221|NCT02777190|142932283|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
71707222|NCT02777190|142932284|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71707223|NCT02777190|142932285|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71654529|NCT00754494|142826711|SUPERIORITY_OR_OTHER|||||||0.762|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.762
71654530|NCT00754494|142826711|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.125
71654531|NCT00754494|142826711|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.855
71654532|NCT00754494|142826712|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.369
71654533|NCT00754494|142826712|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.085
71654534|NCT00754494|142826712|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.233
71654535|NCT00754494|142826713|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.651
71654536|NCT00754494|142826713|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
71654537|NCT00754494|142826713|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.261
71654538|NCT00754494|142826714|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.654
71654539|NCT00754494|142826714|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.030
71707224|NCT02777190|142932286|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71707225|NCT02777190|142932287|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
71707226|NCT02777190|142932289|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
71707227|NCT02777190|142932290|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71707228|NCT02777190|142932291|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.04
71707229|NCT02777190|142932292|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71707230|NCT02777190|142932293|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71654540|NCT00754494|142826714|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.||||0.083
71707231|NCT03733483|142932309|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on P1NP levels. Change in P1NP in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.53|||||||Mixed Models Analysis|||||||0.53
71707232|NCT03733483|142932310|EQUIVALENCE|Maximum likelihood estimates in a repeated measures model were used to assess the effect of insufficient sleep on CTX levels. Change in CTX in response to insufficient sleep was assessed using values measured every two hours on two, 24-h profiles obtained at baseline and on night 6 of sleep restriction. Circadian rhythmicity was included in the repeated-measures model as diurnal variation has been documented in prior studies. Data are presented as estimate ± standard error of the estimate.||||||0.1|||||||Mixed Models Analysis|||||||0.10
71707233|NCT00472641|142932311|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
71707234|NCT00472641|142932312|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Random Regression Mixed Effects Modeling|||||||<0.00001
71707235|NCT03721107|142932313|SUPERIORITY||Difference in Percentage|7.9||||0.152|TWO_SIDED|95.0|-6.0|21.9||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||21.9|-6.0|0.152
71654541|NCT02654587|142826748|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.05|TWO_SIDED|95.0|0.38|0.91||OS in patients with ICI secondary resistance|t-test, 2 sided||p=0.017|||0.91|0.38|<0.05
71654542|NCT02654587|142826748|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.36|TWO_SIDED|95.0|0.62|1.19|||t-test, 2 sided|||OS in the ITT population with ICI resistance (primary and secondary resistance)||1.19|0.62|0.36
71654543|NCT02654587|142826749|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.004|TWO_SIDED|95.0|0.27|0.79|||t-test, 2 sided|||Post-progression survival in patients with ICI secondary resistance||0.79|0.27|0.004
71654544|NCT02654587|142826749|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0035|TWO_SIDED|95.0|0.39|0.83|||t-test, 2 sided|||Post-progression survival in ITT population with ICI resistance (primary and secondary)||0.83|0.39|0.0035
71654545|NCT02654587|142826750|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.006|TWO_SIDED|95.0|0.23|0.8|||t-test, 2 sided|||Time to worsening ECOG PS \>1 in patients with ICI secondary resistance||0.80|0.23|0.006
71654546|NCT02654587|142826750|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.02|TWO_SIDED|95.0|0.35|0.92|||t-test, 2 sided|||Time to worsening ECOG PS in the ITT population with ICI resistance (primary and secondary)||0.92|0.35|0.02
71654547|NCT02654587|142826751|SUPERIORITY||P Value|0.045|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ C30 Global Health Status in Patients with ICI secondary resistance||||<0.05
71654548|NCT02654587|142826751|SUPERIORITY||P Value|0.07||||0.07|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Physical functioning in patients with ICI secondary resistance||||0.07
71654549|NCT02654587|142826751|SUPERIORITY||P Value|0.03|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Role functioning in patients with ICI secondary resistance||||<0.05
71654550|NCT02654587|142826751|SUPERIORITY||P Value|0.36||||0.36|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Emotional functioning in patients with ICI secondary resistance||||0.36
71654551|NCT02654587|142826751|SUPERIORITY||P Value|0.24||||0.24|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Cognitive functioning in patients with ICI secondary resistance||||0.24
71654552|NCT02654587|142826751|SUPERIORITY|QLQ-C30 Social functioning|P Value|0.11||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
71654553|NCT02654587|142826752|SUPERIORITY||P Value|0.06||||0.06|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Fatigue in ICI secondary resistance||||0.06
71654554|NCT02654587|142826752|SUPERIORITY||P Value|0.0003||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Constipation in ICI secondary resistance||||0.0003
71654555|NCT02654587|142826752|SUPERIORITY||P Value|0.8||||0.8|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Dyspnea in ICI secondary resistance||||0.80
71654556|NCT02654587|142826752|SUPERIORITY||P Value|0.21||||0.21|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Nausea and Vomiting in ICI secondary resistance||||0.21
71654557|NCT02654587|142826752|SUPERIORITY||P Value|0.45||||0.45|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Pain in ICI secondary resistance||||0.45
71654558|NCT02654587|142826752|SUPERIORITY||P Value|0.87||||0.87|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Insomnia in ICI secondary resistance||||0.87
71707236|NCT03721107|142932313|SUPERIORITY||Difference in Percentage|5.6||||0.216|TWO_SIDED|95.0|-6.8|18.0||P-value is from a 1-sided Pearson chi-square test with Yates' correction with null hypothesis that the difference in proportions Blautix - placebo \<=0 versus the difference is \>0. The significance level for rejection of the null hypotheses is 0.10.|Chi-squared, Corrected|||||18.0|-6.8|0.216
71738983|NCT00620113|142990731|SUPERIORITY_OR_OTHER||Difference in LS Means|2.23|||<|0.001|TWO_SIDED|95.0|1.03|3.43||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.43|1.03|<0.001
71654559|NCT02654587|142826752|SUPERIORITY||P Value|0.59||||0.59|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Appetite loss in ICI secondary resistance||||0.59
71654560|NCT02654587|142826752|SUPERIORITY||P Value|0.88||||0.88|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Diarrhea in ICI secondary resistance||||0.88
71707237|NCT01378273|142932335|SUPERIORITY|We assumed no effect of treatment on death, but that Epo will lead to a decrease in the rate of NDI. If we assume a multiplicative reduction in the NDI rate of 0.45 then we expect a treated NDI rate of 12 percent and an overall rate of death+NDI of 30.4% as compared to the control rate of 40.4% corresponding to an overall treatment rate ratio of 0.75. This leads to a sample size of 376 evaluated subjects per arm or a total evaluated sample size of 752 subjects.|Risk Ratio (RR)|1.03||||0.05|TWO_SIDED|0.05|0.81|1.32||A two-sided type I error of 0.05 with no formal adjustment for multiple comparisons unless otherwise specified (such as with safety outcomes).|GEE Wald test based on logistic regressi|adjustments were made for gestational age at birth and recruitment site as a fixed effect.|The numerator is the Epo group, denominator is the control group|We evaluated the primary outcome of death or neurodevelopmental impairment using generalized estimating equations to account for potential correlation within siblings from the same pregnancy, with adjustment for gestational age at birth and recruitment site as a fixed effect. The primary analysis included infants with complete data and excluded data from infants known to be alive but in whom neurodevelopmental outcomes were not assessed.||1.32|0.81|0.05
71654561|NCT02654587|142826752|SUPERIORITY||P Value|0.37||||0.37|TWO_SIDED||||||Mixed Models Analysis|||QLQ-C30 Financial difficulties in ICI secondary resistance||||0.37
71654562|NCT02654587|142826753|SUPERIORITY||P Value|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Alopecia in ICI secondary resistance||||<0.0001
71654563|NCT02654587|142826753|SUPERIORITY||P Value|0.03||||0.03|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Peripheral neuropathy in ICI secondary resistance||||0.03
71654564|NCT02654587|142826753|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Sore mouth in ICI secondary resistance||||0.01
71654565|NCT02654587|142826753|SUPERIORITY||P Value|0.01||||0.01|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Dysphagia in ICI secondary resistance||||0.01
71654566|NCT02654587|142826753|SUPERIORITY||P Value|0.35||||0.35|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in arm and shoulder||||0.35
71707238|NCT01378273|142932336|OTHER|SAEs were defined prospectively. The rate of total SAEs observed through hospital discharge were compared after accounting for potential within-sibship correlation (with multiple gestations) using Generalized Estimating Equations (GEE) with robust standard errors. We used a GEE Wald test based on Poisson or logistic regression for total SAE count and individual events respectively. All other non-categorical data were assessed with GEE regression models appropriate for continuous outcomes.|Risk Ratio (RR)|1.01||||0.05|TWO_SIDED|95.0|0.83|1.22||Statistical significance was set at 0.05 for the efficacy analysis and for the final safety analysis comparing the rate of total SAEs between treatment groups, and 0.031 for death and 0.004 for the ten individual SAEs due to sequential monitoring.|Poisson regression|Adjusted for multiple gestation and gestational age|Epo is numerator and Control is denominator|We hypothesized that Epo would be safe, with no excess of SAEs compared to control infants. Sample size was based on the primary outcome, severe neurodevelopmental impairment or death.||1.22|0.83|0.05
71654567|NCT02654587|142826753|SUPERIORITY||P Value|0.43||||0.43|TWO_SIDED||||||Mantel Haenszel|||QLQ-LC13 Pain in chest in ICI secondary resistance||||0.43
71654568|NCT02654587|142826753|SUPERIORITY||P Value|0.78||||0.78|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Pain in other parts||||0.78
71654569|NCT02654587|142826753|SUPERIORITY||P Value|0.23||||0.23|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC 13 Hemoptysis in ICI secondary resistance||||0.23
71654570|NCT02654587|142826753|SUPERIORITY||P Value|0.54||||0.54|TWO_SIDED||||||Mixed Models Analysis|||QLQ-LC13 Coughing in ICI secondary resistance||||0.54
71654571|NCT02654587|142826754|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.43|2.75|||Mantel Haenszel|||DCR at 6 months in patients with ICI secondary resistance||2.75|0.43|0.87
71654572|NCT02654587|142826754|SUPERIORITY||Odds Ratio (OR)|0.73||||0.37|TWO_SIDED|95.0|0.36|1.46|||Mantel Haenszel|||DCR at 6 months in ITT patients with ICI resistance (primary and secondary)||1.46|0.36|0.37
71654573|NCT02654587|142826755|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.29|TWO_SIDED|95.0|0.82|2.0|||t-test, 2 sided|||Median PFS in patients with ICI secondary resistance||2.0|0.82|0.29
71654574|NCT02654587|142826755|SUPERIORITY||Hazard Ratio (HR)|1.64|||<|0.05|TWO_SIDED|95.0|1.18|2.28|||t-test, 2 sided|||Median PFS in ITT patients with ICI resistance (primary and secondary)||2.28|1.18|<0.05
71654575|NCT02654587|142826756|SUPERIORITY|ORR in ICI secondary resistance|Odds Ratio (OR)|0.33||||0.07|TWO_SIDED|95.0|0.1|1.11|||Mantel Haenszel|||||1.11|0.10|0.07
71654576|NCT02654587|142826756|SUPERIORITY|ORR in ITT population with ICI resistance (primary and secondary)|Odds Ratio (OR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.59|||Mantel Haenszel|||||0.59|0.08|0.002
71707239|NCT01378273|142932337|SUPERIORITY|||||||0.36||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.05.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For all statistical comparisons between groups, Generalized Estimating Equations (GEE) with robust standard errors and a working independence correlation structure for infants included from a multiple gestation were used. A GEE-based Wald test was used to examine differences in the global brain injury severity score between treatment groups, with adjustment for gestational age (GA) at birth used to stratify treatment randomization (24+0 to 25+6 vs. 26+0 to 27+6 in weeks+days of GA).||||0.36
71654577|NCT02654587|142826757|SUPERIORITY|Duration of response at 6 months in ICI secondary resistance|Hazard Ratio (HR)|1.14||||0.88|TWO_SIDED|95.0|0.25|5.3|||Regression, Cox|||||5.30|0.25|0.88
71707240|NCT01378273|142932338|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a Wald's test and declared significant if p \< 0.007.|Generalized estimating equation|Adjusted for gestational age at birth and treatment assignment.||For statistical inference, we utilized generalized estimating equations (GEE) with robust standard errors to appropriately account for potential correlation of biomarkers for same-birth siblings. Each respective GEE model adjusted for gestational age at birth and treatment assignment as fixed factors associated with the original study design. Biomarker levels at each follow-up time point were analysed using separate GEE models. Epo levels were log-transformed in all statistical analyses.||||<0.001
71764944|NCT03698591|143032069|OTHER||F-statistic|3.196||||0.085|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.085
71707241|NCT05259722|142932374|SUPERIORITY||Mean Difference (Net)|-16.1|||<|0.001|TWO_SIDED|95.0|-23.28|-8.86|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-8.86|-23.28|<0.001
71707242|NCT05259722|142932375|SUPERIORITY||Risk Difference (RD)|12.6|||=|0.003|TWO_SIDED|95.0|4.34|20.78|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||20.78|4.34|=0.003
71707243|NCT05259722|142932376|SUPERIORITY||Risk Difference (RD)|10.6|||=|0.004|TWO_SIDED|95.0|3.31|17.87|||Cochran-Mantel-Haenszel|||The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by hyperkeratotic/non-hyperkeratotic subtype. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||17.87|3.31|=0.004
71707244|NCT05259722|142932377|SUPERIORITY||Mean Difference (Net)|-0.7|||=|0.005|TWO_SIDED|95.0|-1.12|-0.2|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.20|-1.12|=0.005
71707245|NCT05259722|142932378|SUPERIORITY||Mean Difference (Net)|-0.6|||=|0.018|TWO_SIDED|95.0|-1.08|-0.1|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-0.10|-1.08|=0.018
71707246|NCT05259722|142932379|SUPERIORITY||Mean Difference (Net)|14.3|||<|0.001|TWO_SIDED|95.0|5.81|22.86|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed as non-response. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||22.86|5.81|<0.001
71707247|NCT05259722|142932380|SUPERIORITY||Mean Difference (Net)|334.0|||<|0.001|TWO_SIDED|95.0|195.69|472.26|||ANCOVA|||The AUC was analysed using a robust ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||472.26|195.69|<0.001
71707248|NCT05259722|142932381|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-32.55|-16.36|||ANCOVA|||The change from baseline was analysed using an ANCOVA model with effects of treatment group, hyperkeratotic/non-hyperkeratotic subtype and baseline value of the score. Missing data was imputed with WOCF. Data after initiation of rescue treatment or permanent discontinuation of IMP was treated as missing.||-16.36|-32.55|<0.001
71707249|NCT02539394|142932392|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.394|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Burden is the same across the 2 arms||||0.394
71707250|NCT02539394|142932392|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.017|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Burden is the same across the 2 arms||||0.017
71707251|NCT02539394|142932392|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.015|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Burden is the same across the 2 arms||||0.015
71707252|NCT02539394|142932392|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.125|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Burden is the same across the 2 arms||||0.125
71707253|NCT02539394|142932393|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.043|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating desire is the same across the 2 arms||||0.043
71707254|NCT02539394|142932393|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.606|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating desire is the same across the 2 arms||||0.606
71707255|NCT02539394|142932393|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.155|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating desire is the same across the 2 arms||||0.155
71707256|NCT02539394|142932393|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating desire is the same across the 2 arms||||0.019
71707257|NCT02539394|142932394|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.25|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Eating duration is the same across the 2 arms||||0.250
71707258|NCT02539394|142932394|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.478|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Eating duration is the same across the 2 arms||||0.478
71707259|NCT02539394|142932394|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.019|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Eating duration is the same across the 2 arms||||0.019
71707260|NCT02539394|142932394|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Eating duration is the same across the 2 arms||||0.049
71654578|NCT02654587|142826757|SUPERIORITY|Duration of Response at 6 months in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.41||||0.57|TWO_SIDED|95.0|0.43|4.6|||Regression, Cox|||||4.60|0.43|0.57
71654579|NCT02654587|142826758|SUPERIORITY|Time to next lung cancer therapy in ICI secondary resistance|Hazard Ratio (HR)|1.85||||0.04|TWO_SIDED|95.0|1.03|3.31|||Regression, Cox|||||3.31|1.03|0.04
71654580|NCT02654587|142826758|SUPERIORITY|Time to next lung cancer therapy in ITT population with ICI resistance (primary and secondary)|Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|1.07|2.36|||Regression, Cox|||||2.36|1.07|0.02
71654581|NCT02654587|142826759|SUPERIORITY||Hazard Ratio (HR)|1.36|||<|0.05|TWO_SIDED|95.0|1.0|1.86|||t-test, 2 sided|||||1.86|1.00|<0.05
71654582|NCT00518882|142826766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority concluded if upper confidence interval of test is below 0.4%|Estimated treatment difference, LS Mean|-0.33|||<|0.0001||95.0|-0.47|-0.18||No multiplicity concerns|ANCOVA|||"ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide \< µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide \< µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%."||-0.18|-0.47|<.0001
71654583|NCT00518882|142826767|SUPERIORITY_OR_OTHER||Mean|0.25|STANDARD_DEVIATION|0.803|<|0.0001||95.0|0.139|0.364|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.364|0.139|<0.0001
71654584|NCT00518882|142826767|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.924||0.9872||95.0|-1.36|0.134|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.134|-1.36|0.9872
71654585|NCT00518882|142826768|SUPERIORITY_OR_OTHER||Mean|-0.98|STANDARD_DEVIATION|1.119|<|0.0001||95.0|-1.137|-0.823|||Paired t-test|||The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.823|-1.137|<0.0001
71654586|NCT00518882|142826768|SUPERIORITY_OR_OTHER||Mean|-0.85|STANDARD_DEVIATION|1.105|<|0.0001||95.0|-1.01|-0.687|||Paired t-test|||The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0 = 0 against HA: µ78 - µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.||-0.687|-1.010|<0.0001
71654587|NCT00518882|142826771|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.38||||0.2235||95.0|-0.99|0.23||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.||0.23|-0.99|0.2235
71654588|NCT00518882|142826772|SUPERIORITY_OR_OTHER||Mean|-0.4|STANDARD_DEVIATION|3.24||0.0793||95.0|-0.86|0.05|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.05|-0.86|0.0793
71654589|NCT00518882|142826772|SUPERIORITY_OR_OTHER||Mean|-0.7|STANDARD_DEVIATION|3.67||0.0075||95.0|-1.26|-0.2|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.20|-1.26|0.0075
71654590|NCT00518882|142826773|SUPERIORITY_OR_OTHER||Mean|-3.3|STANDARD_DEVIATION|4.63|<|0.0001||95.0|-3.9|-2.61|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.61|-3.90|<0.0001
71654591|NCT00518882|142826773|SUPERIORITY_OR_OTHER||Mean|-3.2|STANDARD_DEVIATION|4.44|<|0.0001||95.0|-3.85|-2.55|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.55|-3.85|<0.0001
71654592|NCT00518882|142826774|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-1.01|||<|0.0001||95.0|-1.37|-0.65||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.||-0.65|-1.37|<0.0001
71654593|NCT00518882|142826775|SUPERIORITY_OR_OTHER||Mean|0.7|STANDARD_DEVIATION|1.84|<|0.0001||95.0|0.48|1.0|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78- µ26=0 against HA: µ78 - µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.00|0.48|<0.0001
71654594|NCT00518882|142826775|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|2.42||0.4864||95.0|-0.48|0.23|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.23|-0.48|0.4864
71886573|NCT04033367|143293412|SUPERIORITY||Least square mean difference|-27.87|||<|0.001|TWO_SIDED|95.0|-37.96|-17.78||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-17.78|-37.96|<0.001
71707261|NCT02539394|142932395|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.376|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Food selection is the same across the 2 arms||||0.376
71707262|NCT02539394|142932395|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.013|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Food selection is the same across the 2 arms||||0.013
71707263|NCT02539394|142932395|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.049|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Food selection is the same across the 2 arms||||0.049
71707264|NCT02539394|142932395|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.3|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Food selection is the same across the 2 arms||||0.300
71707265|NCT02539394|142932396|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.037|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Communication is the same across the 2 arms||||0.037
71707266|NCT02539394|142932396|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.858|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Communication is the same across the 2 arms||||0.858
71707267|NCT02539394|142932396|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Communication is the same across the 2 arms||||0.042
71707268|NCT02539394|142932396|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.031|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Communication is the same across the 2 arms||||0.031
71707269|NCT02539394|142932397|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.343|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fear swallow is the same across the 2 arms||||0.343
71707270|NCT02539394|142932397|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.022|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.022
71707271|NCT02539394|142932397|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.018|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fear swallow is the same across the 2 arms||||0.018
71707272|NCT02539394|142932397|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.008|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fear swallow is the same across the 2 arms||||0.008
71707273|NCT02539394|142932398|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.28|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Social is the same across the 2 arms||||0.280
71707274|NCT02539394|142932398|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.483|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Social is the same across the 2 arms||||0.483
71707275|NCT02539394|142932398|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.07|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Social is the same across the 2 arms||||0.070
71707276|NCT02539394|142932398|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.2|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Social is the same across the 2 arms||||0.200
71707277|NCT02539394|142932399|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Mental is the same across the 2 arms||||0.148
71707278|NCT02539394|142932399|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Mental is the same across the 2 arms||||0.040
71707279|NCT02539394|142932399|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Mental is the same across the 2 arms||||0.042
71707280|NCT02539394|142932399|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.319|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Mental is the same across the 2 arms||||0.319
71707281|NCT02539394|142932400|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.161|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Sleep is the same across the 2 arms||||0.161
71707282|NCT02539394|142932400|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.763|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Sleep is the same across the 2 arms||||0.763
71707283|NCT02539394|142932400|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.178|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Sleep is the same across the 2 arms||||0.178
71707284|NCT02539394|142932400|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.091|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Sleep is the same across the 2 arms||||0.091
71707285|NCT02539394|142932401|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.602|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative SWAL-QOL - Fatigue is the same across the 2 arms||||0.602
71764945|NCT03698591|143032069|OTHER||F-statistic|0.396||||0.535|TWO_SIDED|||||A priori threshold of p \< .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distraction performance. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.||||.535
71707286|NCT02539394|142932401|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.302|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 SWAL-QOL - Fatigue is the same across the 2 arms||||0.302
71707287|NCT02539394|142932401|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.114|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 SWAL-QOL - Fatigue is the same across the 2 arms||||0.114
71764946|NCT01675167|143032100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98|||<|1e-05|TWO_SIDED|95.0|-1.32|-0.64||P value was adjusted using weighted z-test (CHW).|ANCOVA|||||-0.64|-1.32|<.00001
71764947|NCT01675167|143032101|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||<.0001
71764948|NCT01675167|143032101|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by Stratum (Dose Level)||Responders with ≥50% pain reduction||||<.0001
71764949|NCT01379508|143032131|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-4.0|||||TWO_SIDED|95.0|-10.5|2.5||||||Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||2.5|-10.5|
71764950|NCT01379508|143032131|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.1|||||TWO_SIDED|95.0|-9.4|3.1||||||Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (\< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (\< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA \< 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine - tenofovir arm) and the 95% CI of the difference.||3.1|-9.4|
71764951|NCT01379508|143032131|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.8|||||TWO_SIDED|95.0|-7.9|0.4||||||Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients||0.4|-7.9|
71764952|NCT01379508|143032131|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-2.3|||||TWO_SIDED|95.0|-8.3|3.8||||||Imputing within +28d DNA for wk52: d/c for non response \<28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure)||3.8|-8.3|
71764953|NCT01457352|143032135|SUPERIORITY|||||||0.2062|||||||Cochran-Mantel-Haenszel|||||||0.2062
71764954|NCT01457352|143032136|SUPERIORITY|||||||0.0485|||||||Mantel Haenszel|||||||0.0485
71764955|NCT04174365|143032143|SUPERIORITY||Least squares (LS) mean difference|-1.22||||0.4597|TWO_SIDED|95.0|-4.49|2.05|||Mixed model repeated measures(MMRM)|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||2.05|-4.49|0.4597
71764956|NCT04174365|143032144|SUPERIORITY||LS mean difference|-0.07||||0.7315|TWO_SIDED|95.0|-0.46|0.32|||MMRM|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction.|MMRM method with model terms: treatment, trial site, baseline body weight stratum, visit, treatment-by-visit and baseline-by-visit interaction. Significance test was based on least-square means using a two-sided 0.05 level.|||0.32|-0.46|0.7315
71707288|NCT02539394|142932401|EQUIVALENCE|43 patient in each group need to achieved \>80% power to detect a 15 point differences in SWAL-QOL survey||||||0.005|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks SWAL-QOL - Fatigue is the same across the 2 arms||||0.005
71764957|NCT02522624|143032295|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
71764958|NCT02522624|143032295|SUPERIORITY_OR_OTHER|||||||0.16||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.16
71764959|NCT02522624|143032295|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Controlling for Numeracy.||||<.001
71707289|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.933|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative Eat-10 is the same across the 2 arms||||0.933
71707290|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.95|||||||Wilcoxon (Mann-Whitney)|||The distribution of Pre-operative modified Eat-10 is the same across the 2 arms||||0.950
71886574|NCT04033367|143293413|SUPERIORITY||Least square mean difference|-15.06|||<|0.001|TWO_SIDED|95.0|-20.56|-9.56||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-9.56|-20.56|<0.001
71886575|NCT04033367|143293414|SUPERIORITY||Least square mean difference|-2.08|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||-1.18|-2.97|<0.001
71707291|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.059|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 Eat-10 is the same across the 2 arms||||0.059
71707292|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.042|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD1 modified Eat-10 is the same across the 2 arms||||0.042
71707293|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.032|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 Eat-10 is the same across the 2 arms||||0.032
71707294|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.014|||||||Wilcoxon (Mann-Whitney)|||The distribution of POD2 modified Eat-10 is the same across the 2 arms||||0.014
71707295|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks Eat-10 is the same across the 2 arms||||0.030
71707296|NCT02539394|142932402|EQUIVALENCE|Two-sided 95% confidence interval||||||0.039|||||||Wilcoxon (Mann-Whitney)|||The distribution of 4-6 weeks modified Eat-10 is the same across the 2 arms||||0.039
71707297|NCT02539394|142932403|EQUIVALENCE|Two-sided||||||0.121|||||||Chi-squared|||Proportion of Pre-operative Bazaz Liquid is the same between the 2 arms||||0.121
71707298|NCT02539394|142932403|EQUIVALENCE|Two-sided||||||0.006|||||||Chi-squared|||Proportion of POD1 Bazaz Liquid is the same between the 2 arms||||0.006
71707299|NCT02539394|142932403|EQUIVALENCE|Two-sided||||||0.329|||||||Chi-squared|||Proportion of POD2 Bazaz Liquid is the same between the 2 arms||||0.329
71707300|NCT02539394|142932403|EQUIVALENCE|Two-sided||||||0.687|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Liquid is the same between the 2 arms||||0.687
71707301|NCT02539394|142932404|EQUIVALENCE|Two-sided||||||0.066|||||||Chi-squared|||Proportion of Pre-operative Bazaz Solid is the same between the 2 arms||||0.066
71707302|NCT02539394|142932404|EQUIVALENCE|Two-sided||||||0.252|||||||Chi-squared|||Proportion of POD1 Bazaz Solid is the same between the 2 arms||||0.252
71707303|NCT02539394|142932404|EQUIVALENCE|Two-sided||||||0.1|||||||Chi-squared|||Proportion of POD2 Bazaz Solid is the same between the 2 arms||||0.100
71707304|NCT02539394|142932404|EQUIVALENCE|Two-sided||||||0.279|||||||Chi-squared|||Proportion of 4-6 weeks Bazaz Solid is the same between the 2 arms||||0.279
71707305|NCT02539394|142932405|EQUIVALENCE|Two-sided 95% confidence interval||||||0.145|||||||t-test, 2 sided|||The means Pre-operative NDI for the two populations is equal||||0.145
71707306|NCT02539394|142932405|EQUIVALENCE|Two-sided 95% confidence interval||||||0.234|||||||t-test, 2 sided|||The means 4-6 weeks NDI for the two populations is equal||||0.234
71707307|NCT02539394|142932410|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71707308|NCT02205359|142932412|SUPERIORITY||Hazard Ratio (HR)|0.888|STANDARD_ERROR_OF_MEAN|0.067||0.077|TWO_SIDED|95.0|0.779|1.013|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.013|0.779|0.077
71707309|NCT02205359|142932413|SUPERIORITY||Hazard Ratio (HR)|0.881|STANDARD_ERROR_OF_MEAN|0.081||0.12|TWO_SIDED|95.0|0.752|1.032|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.032|0.752|0.12
71707310|NCT02205359|142932414|SUPERIORITY||Hazard Ratio (HR)|0.906|STANDARD_ERROR_OF_MEAN|0.09||0.28|TWO_SIDED|95.0|0.759|1.082|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect|Stratified by NYHA class and with investigational site as a random effect, Standard Error reported on log hazard scale|||1.082|0.759|0.28
71707311|NCT02205359|142932415|SUPERIORITY|Endpoint for statistical analysis is the proportion Improved.|Odds Ratio (OR)|0.888|STANDARD_ERROR_OF_MEAN|0.074||0.11|TWO_SIDED|95.0|0.768|1.026|||Regression, Logistic|Stratified by NYHA class and with investigational site as a random effect|Standard Error is on log-odds ratio scale|||1.026|0.768|0.11
71707312|NCT02205359|142932416|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.85|1.16|||Regression, Cox|Stratified by NYHA class and with investigational site as a random effect||||1.16|0.85|0.89
71707313|NCT02205359|142932417|SUPERIORITY||Difference in mean change from baseline|-0.07||||0.88|TWO_SIDED|95.0|-1.03|0.89|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.89|-1.03|0.88
71707314|NCT02205359|142932418|SUPERIORITY||Difference in mean change from baseline|0.0013||||0.75|TWO_SIDED|95.0|-0.0068|0.0094|||ANCOVA|Stratified by NYHA class and with investigational site as a random effect||||0.0094|-0.0068|0.75
71707315|NCT02205359|142932419|SUPERIORITY||rate ratio|1.15||||0.52|TWO_SIDED|95.0|0.75|1.75|||negative binomial regression|Stratified by NYHA class||||1.75|0.75|0.52
71707316|NCT01793129|142932465|SUPERIORITY|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that id does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.74|2.0|||||The relative risk estimate was calculated by dividing risk under hypothermia by risk under normothermia.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|To get estimates of RR from the Bayesian logistic regression model, predicted probabilities of the outcome were generated for all infants assuming the infants were treated with and without hypothermia and with/without severe encephalopathy. Next subject level RR values were estimated for all infants and 2.5, 50, and 97.5 percentiles were calculated.|2.00|0.74|
71764960|NCT02522624|143032296|SUPERIORITY_OR_OTHER|||||||0.002||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||0.002
71886576|NCT04033367|143293415|SUPERIORITY||Least square mean difference|-3.61|||<|0.001|TWO_SIDED|95.0|-5.68|-1.53||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||-1.53|-5.68|<0.001
71707317|NCT03681093|142932487|SUPERIORITY||Least Squares (LS) Mean|0.05|STANDARD_ERROR_OF_MEAN|0.323||0.979|TWO_SIDED|95.0|-0.59|0.7||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|Mixed Model for Repeated Measures (MMRM)|||||0.70|-0.59|0.979
71707318|NCT03681093|142932487|SUPERIORITY||LS Mean|-0.25|STANDARD_ERROR_OF_MEAN|0.319||0.656|TWO_SIDED|95.0|-0.88|0.39||Adjusted p-value is reported. The adjusted p-value was obtained from the Dunnet Multiplicity Correction applied to control the Type I error for the primary analysis.|MMRM|||||0.39|-0.88|0.656
71707319|NCT03681093|142932488|SUPERIORITY||LS Mean|0.64|STANDARD_ERROR_OF_MEAN|0.249||0.012|TWO_SIDED|95.0|0.15|1.14||Unadjusted p-value|MMRM|||||1.14|0.15|0.012
71707320|NCT03681093|142932488|SUPERIORITY||LS Mean|0.45|STANDARD_ERROR_OF_MEAN|0.248||0.074|TWO_SIDED|95.0|-0.04|0.94||Unadjusted p-value|MMRM|||||0.94|-0.04|0.074
71707321|NCT03681093|142932489|SUPERIORITY||LS Mean|5.22|STANDARD_ERROR_OF_MEAN|4.881||0.288|TWO_SIDED|95.0|-4.49|14.93||Unadjusted p-value|MMRM|||||14.93|-4.49|0.288
71707322|NCT03681093|142932489|SUPERIORITY||LS Mean|-2.17|STANDARD_ERROR_OF_MEAN|4.936||0.661|TWO_SIDED|95.0|-11.99|7.65||Unadjusted p-value|MMRM|||||7.65|-11.99|0.661
71707323|NCT03681093|142932490|SUPERIORITY||LS Mean|0.61|STANDARD_ERROR_OF_MEAN|1.809||0.735|TWO_SIDED|95.0|-2.98|4.21||Unadjusted p-value|MMRM|||||4.21|-2.98|0.735
71707324|NCT03681093|142932490|SUPERIORITY||LS Mean|4.51|STANDARD_ERROR_OF_MEAN|1.821||0.015|TWO_SIDED|95.0|0.89|8.13||Unadjusted p-value|MMRM|||||8.13|0.89|0.015
71707325|NCT05033561|142932493|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
71707326|NCT05033561|142932493|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
71707327|NCT05033561|142932494|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
71707328|NCT05033561|142932494|NON_INFERIORITY|Non-inferiority would be verified if the lower bound of the two-sided 95% CI around each difference (shorter interval minus standard interval) is greater than -10%.||||||0.05||||||This is the nominal alpha level for the two-sided confidence interval comparison.|Miettinen-Nurminen|Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.||This study was designed to demonstrate the non-inferiority of Group A (1-week interval nOPV2 administration) and Group B (2-weeks interval nOPV2 administration) versus Group C (standard 4-week interval).||||0.05
71707329|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.137|TWO_SIDED|95.0|0.739|1.042|||Cox Proportional Hazards Model|||||1.042|0.739|0.137
71707330|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|12.2|||||TWO_SIDED|95.0|-4.2|26.1|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||26.1|-4.2|
71707331|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.284|TWO_SIDED|95.0|0.767|1.081|||Cox Proportional Hazards Model|||||1.081|0.767|0.284
71707332|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.9|||||TWO_SIDED|95.0|-8.1|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.1|
71707333|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.962||||0.655|TWO_SIDED|95.0|0.813|1.139|||Cox Proportional Hazards Model|||||1.139|0.813|0.655
71707334|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.8|||||TWO_SIDED|95.0|-13.9|18.7|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||18.7|-13.9|
71707335|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.681|TWO_SIDED|95.0|0.808|1.149|||Cox Proportional Hazards Model|||||1.149|0.808|0.681
71707336|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|3.6|||||TWO_SIDED|95.0|-14.9|19.2|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.2|-14.9|
71707337|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912||||0.299|TWO_SIDED|95.0|0.767|1.085|||Cox Proportional Hazards Model|||||1.085|0.767|0.299
71707338|NCT01313676|142932515|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|8.8|||||TWO_SIDED|95.0|-8.5|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.3|-8.5|
71707339|NCT01313676|142932516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.019|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||||15|1|0.019
71886577|NCT04033367|143293416|SUPERIORITY||Least square mean difference|9.97||||0.297|TWO_SIDED|95.0|-8.86|28.79||Threshold of significance at 0.05.|Mixed Models Analysis||Dupilumab versus Placebo|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||28.79|-8.86|0.297
71886578|NCT02723201|143293426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.402|||<|0.001|TWO_SIDED|90.0|0.32|0.505|||ANOVA|||Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.||0.505|0.320|<0.001
71886579|NCT02723201|143293426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.216||||0.249|TWO_SIDED|90.0|1.016|1.455|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.455|1.016|0.249
71886580|NCT02723201|143293426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.055|||<|0.001|TWO_SIDED|90.0|0.041|0.074|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.074|0.041|<0.001
71886581|NCT02723201|143293426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.685||||0.054|TWO_SIDED|90.0|0.499|0.939|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.939|0.499|0.054
71886582|NCT02723201|143293428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.648||||0.007|TWO_SIDED|90.0|0.497|0.844|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.844|0.497|0.007
71707340|NCT01313676|142932516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.5||0.026|TWO_SIDED|95.0|1.0|14.0|||Mixed Models Analysis|||||14|1|0.026
71707341|NCT01313676|142932516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.4||0.654|TWO_SIDED|95.0|-8.0|5.0|||Mixed Models Analysis|||||5|-8|0.654
71707342|NCT01313676|142932516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|3.4||0.913|TWO_SIDED|95.0|-6.0|7.0|||Mixed Models Analysis|||||7|-6|0.913
71707343|NCT01313676|142932516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|3.4||0.004|TWO_SIDED|95.0|3.0|16.0|||Mixed Models Analysis|||||16|3|0.004
71707344|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.926||||0.475|TWO_SIDED|95.0|0.75|1.143|||Cox Proportional Hazards Model|||||1.143|0.750|0.475
71707345|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|7.4|||||TWO_SIDED|95.0|-14.3|25.0|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||25.0|-14.3|
71707346|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.317|TWO_SIDED|95.0|0.723|1.111|||Cox Proportional Hazards Model|||||1.111|0.723|0.317
71707347|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Percent reduction in risk of CV event|10.4|||||TWO_SIDED|95.0|-11.1|27.7|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||27.7|-11.1|
71707348|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.908|TWO_SIDED|95.0|0.802|1.217|||Cox Proportional Hazards Model|||||1.217|0.802|0.908
71707349|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|1.2|||||TWO_SIDED|95.0|-21.7|19.8|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||19.8|-21.7|
71707350|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.763|TWO_SIDED|95.0|0.834|1.281|||Cox Proportional Hazards Model|||||1.281|0.834|0.763
71707351|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|-3.3|||||TWO_SIDED|95.0|-28.1|16.6|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||16.6|-28.1|
71707352|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.545|TWO_SIDED|95.0|0.761|1.155|||Cox Proportional Hazards Model|||||1.155|0.761|0.545
71707353|NCT01313676|142932517|SUPERIORITY_OR_OTHER||Percent reduction in risk of death|6.2|||||TWO_SIDED|95.0|-15.5|23.9|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)\*100|||23.9|-15.5|
71707354|NCT02935036|142932524|SUPERIORITY||LS Mean Difference|1.33||||0.5947|TWO_SIDED||||||ANOVA|||||||0.5947
71707355|NCT02935036|142932525|SUPERIORITY||LS Mean Difference|2.75||||0.2912|TWO_SIDED||||||ANOVA|||||||0.2912
71886583|NCT02723201|143293428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.18||||0.423|TWO_SIDED|90.0|1.088|1.279|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||1.279|1.088|0.423
71886584|NCT02723201|143293428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.116|||<|0.001|TWO_SIDED|90.0|0.077|0.176|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.176|0.077|<0.001
71886585|NCT02723201|143293428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.836||||0.037|TWO_SIDED|90.0|0.731|0.957|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.||0.957|0.731|0.037
71654595|NCT00518882|142826776|SUPERIORITY_OR_OTHER||Mean|-1.3|STANDARD_DEVIATION|2.5|<|0.0001||95.0|-1.62|-0.92|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.92|-1.62|<0.0001
71654596|NCT00518882|142826776|SUPERIORITY_OR_OTHER||Mean|-0.8|STANDARD_DEVIATION|2.76|<|0.0001||95.0|-1.23|-0.42|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 - µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.42|-1.23|<0.0001
71654597|NCT00518882|142826777|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|1.33|||<|0.0001||95.0|0.8|1.86||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.86|0.80|<.0001
71654598|NCT00518882|142826778|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.9849||95.0|-0.52|0.53||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.53|-0.52|0.9849
71654599|NCT00518882|142826779|SUPERIORITY_OR_OTHER||LS Mean|1.01||||0.0005||95.0|0.44|1.57||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.57|0.44|0.0005
71654600|NCT00518882|142826780|SUPERIORITY_OR_OTHER||Mean|-0.22|STANDARD_DEVIATION|2.866||0.2972||95.0|-0.626|0.192|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.192|-0.626|0.2972
71654601|NCT00518882|142826780|SUPERIORITY_OR_OTHER||Mean|1.15|STANDARD_DEVIATION|3.253|<|0.0001||95.0|0.66|1.637|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.637|0.660|<0.0001
71654602|NCT00518882|142826781|SUPERIORITY_OR_OTHER||Mean|0.05|STANDARD_DEVIATION|3.307||0.8396||95.0|-0.424|0.521|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.521|-0.424|0.8396
71654603|NCT00518882|142826781|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|3.419||0.7278||95.0|-0.604|0.423|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.423|-0.604|0.7278
71654604|NCT00518882|142826782|SUPERIORITY_OR_OTHER||Mean|0.22|STANDARD_DEVIATION|3.053||0.3271||95.0|-0.219|0.654|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.654|-0.219|0.3271
71654605|NCT00518882|142826782|SUPERIORITY_OR_OTHER||Mean|1.07|STANDARD_DEVIATION|3.775||0.0003||95.0|0.497|1.634|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.634|0.497|0.0003
71654606|NCT00518882|142826783|SUPERIORITY_OR_OTHER||Mean|-1.08|STANDARD_DEVIATION|3.662|<|0.0001||95.0|-1.605|-0.562|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.562|-1.605|<0.0001
71654607|NCT00518882|142826783|SUPERIORITY_OR_OTHER||Mean|-0.99|STANDARD_DEVIATION|3.467||0.0003||95.0|-1.517|-0.458|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.458|-1.517|0.0003
71654608|NCT00518882|142826784|SUPERIORITY_OR_OTHER||Mean|0.26|STANDARD_DEVIATION|4.158||0.3859||95.0|-0.331|0.853|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.853|-0.331|0.3859
71654609|NCT00518882|142826784|SUPERIORITY_OR_OTHER||Mean|-0.37|STANDARD_DEVIATION|3.838||0.2119||95.0|-0.956|0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.214|-0.956|0.2119
71707356|NCT02935036|142932526|SUPERIORITY||Percent difference|2.4||||0.692|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6920
71707357|NCT06844812|142932534|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
71707358|NCT06844812|142932535|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|paired t-test||||||0.021
71707359|NCT06844812|142932536|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|paired t-test||||||0.003
71654610|NCT00518882|142826785|SUPERIORITY_OR_OTHER||Mean|-0.35|STANDARD_DEVIATION|3.975||0.229||95.0|-0.917|0.2211|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.2211|-0.917|0.2290
71707360|NCT06844812|142932537|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71707361|NCT06844812|142932538|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71707362|NCT00368849|142932551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.63|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.63
71707363|NCT00368849|142932552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.09|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.09
71707364|NCT00368849|142932553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.46|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.46
71707365|NCT00368849|142932554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.84|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.84
71707366|NCT00368849|142932555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.76|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.||||0.76
71654611|NCT00518882|142826785|SUPERIORITY_OR_OTHER||Mean|-0.95|STANDARD_DEVIATION|3.23||0.0002||95.0|-1.449|-0.459|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.459|-1.449|0.0002
71654612|NCT00518882|142826786|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.73||||0.0124||95.0|0.16|1.31||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.31|0.16|0.0124
71654613|NCT00518882|142826787|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.39||||0.143||95.0|-0.91|0.13||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.13|-0.91|0.1430
71654614|NCT00518882|142826788|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.54||||0.038||95.0|0.03|1.05||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||1.05|0.03|0.0380
71654615|NCT00518882|142826789|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|2.827||0.77||95.0|-0.344|0.463|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.463|-0.344|0.7700
71654616|NCT00518882|142826789|SUPERIORITY_OR_OTHER||Mean|0.72|STANDARD_DEVIATION|3.27||0.0042||95.0|0.23|1.212|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||1.212|0.230|0.0042
71654617|NCT00518882|142826790|SUPERIORITY_OR_OTHER||Mean|0.67|STANDARD_DEVIATION|3.041||0.0026||95.0|0.238|1.106|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.106|0.238|0.0026
71707367|NCT02006836|142932556|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 1 sided|||H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people \> 0 α=5%||||0.005
71707368|NCT02006836|142932557|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast \> 0 α=5%~* g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~* g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."||||>0.05
71826374|NCT04341298|143157220|SUPERIORITY|||||||0.59|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects requiring abortive medication within 8 hours were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects requiring abortive medication within 8 hours and the type of device, across all strata.||||0.59
71707369|NCT02006836|142932558|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch \> 0 α=5%~* g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch.~* g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch."||||>0.05
71826375|NCT04341298|143157221|SUPERIORITY|||||||0.19|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 2 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 2 hours and the type of device, across all strata.||||0.19
71654618|NCT00518882|142826790|SUPERIORITY_OR_OTHER||Mean|-0.09|STANDARD_DEVIATION|2.989||0.6845||95.0|-0.541|0.356|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.356|-0.541|0.6845
71654619|NCT00518882|142826791|SUPERIORITY_OR_OTHER||Mean|0.32|STANDARD_DEVIATION|2.705||0.1041||95.0|-0.066|0.706|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.706|-0.066|0.1041
71654620|NCT00518882|142826791|SUPERIORITY_OR_OTHER||Mean|0.58|STANDARD_DEVIATION|3.114||0.0151||95.0|0.114|1.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||1.052|0.114|0.0151
71654621|NCT00518882|142826792|SUPERIORITY_OR_OTHER||Mean|-3.31|STANDARD_DEVIATION|3.857|<|0.0001||95.0|-3.861|-2.763|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.763|-3.861|<0.0001
71654622|NCT00518882|142826792|SUPERIORITY_OR_OTHER||Mean|-3.13|STANDARD_DEVIATION|3.56|<|0.0001||95.0|-3.673|-2.589|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-2.589|-3.673|<0.0001
71654623|NCT00518882|142826793|SUPERIORITY_OR_OTHER||Mean|-1.93|STANDARD_DEVIATION|3.703|<|0.0001||95.0|-2.457|-1.403|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.403|-2.457|<0.0001
71654624|NCT00518882|142826793|SUPERIORITY_OR_OTHER||Mean|-2.17|STANDARD_DEVIATION|3.654|<|0.0001||95.0|-2.731|-1.618|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.618|-2.731|<0.0001
71654625|NCT00518882|142826794|SUPERIORITY_OR_OTHER||Mean|-2.21|STANDARD_DEVIATION|3.752|<|0.0001||95.0|-2.747|-1.676|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.676|-2.747|<0.0001
71654626|NCT00518882|142826794|SUPERIORITY_OR_OTHER||Mean|-2.55|STANDARD_DEVIATION|3.625|<|0.0001||95.0|-3.104|-1.997|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-1.997|-3.104|<0.0001
71654627|NCT00518882|142826795|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|29.37|||<|0.0001||95.0|16.81|41.93||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||41.93|16.81|<.0001
71654628|NCT00518882|142826796|SUPERIORITY_OR_OTHER||Mean|-18.18|STANDARD_DEVIATION|62.811|<|0.0001||95.0|-26.988|-9.382|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-9.382|-26.988|<0.0001
71654629|NCT00518882|142826796|SUPERIORITY_OR_OTHER||Mean|2.49|STANDARD_DEVIATION|52.997||0.5304||95.0|-5.327|10.307|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||10.307|-5.327|0.5304
71764961|NCT02522624|143032296|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.30
71764962|NCT02522624|143032296|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Controlling for Numeracy.||||0.82
71764963|NCT02522624|143032297|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||||||<.001
71826376|NCT04341298|143157222|SUPERIORITY|||||||1|||||||Mantel Haenszel|Subjects were stratified based on baseline pain score (6-7 vs. 8-10) prior to analysis using Cochran-Mantel-Haenszel test||Each subject was stratified by baseline pain score for the first severe headache that they experienced (score of 6-7 vs. 8-10). The total number of subjects, and the number of subjects experiencing light sensitivity after 4 hours, were tabulated within each stratum. A Cochran-Mantel-Haenszel test was conducted to test the hypothesis of lack of association between the proportion of subjects reporting light sensitivity after 4 hours and the type of device, across all strata.||||1.0
71707370|NCT02006836|142932559|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner \> 0 α=5%~* g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner.~* g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner."||||>0.05
71764964|NCT02522624|143032297|SUPERIORITY_OR_OTHER|||||||0.82|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.82
71826377|NCT04341298|143157223|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|Pain score difference after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 2 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.021
71826378|NCT04341298|143157224|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Pain score difference after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that 4 hour difference in pain score is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.019
71654630|NCT00518882|142826797|SUPERIORITY_OR_OTHER||Mean|24.86|STANDARD_DEVIATION|59.326|<|0.0001||95.0|16.348|33.374|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||33.374|16.348|<0.0001
71654631|NCT00518882|142826797|SUPERIORITY_OR_OTHER||Mean|11.13|STANDARD_DEVIATION|87.145||0.092||95.0|-1.835|24.093|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||24.093|-1.835|0.0920
71654632|NCT00518882|142826798|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.11||||0.0946||95.0|-0.23|0.02||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.02|-0.23|0.0946
71654633|NCT00518882|142826799|SUPERIORITY_OR_OTHER||Mean|0.11|STANDARD_DEVIATION|0.774||0.0513||95.0|-0.001|0.216|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.216|-0.001|0.0513
71654634|NCT00518882|142826799|SUPERIORITY_OR_OTHER||Mean|0.12|STANDARD_DEVIATION|0.804||0.0513||95.0|-0.001|0.233|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.233|-0.001|0.0513
71707371|NCT02006836|142932560|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||H0: AUC||||>0.05
71764965|NCT02522624|143032297|SUPERIORITY_OR_OTHER|||||||0.15|||||||Regression, Linear|||Controlling for Numeracy.||||0.15
71764966|NCT02522624|143032298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1|TWO_SIDED|95.0|0.92|2.36||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||2.36|0.92|0.10
71764967|NCT02522624|143032298|SUPERIORITY_OR_OTHER|||||||0.26|||||||Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.26
71764968|NCT02522624|143032298|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Linear|||Controlling for Numeracy.||||0.58
71764969|NCT02522624|143032299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52|||<|0.001|TWO_SIDED|95.0|1.58|4.01||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||4.01|1.58|<.001
71764970|NCT02522624|143032299|SUPERIORITY_OR_OTHER|||||||0.39||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.39
71764971|NCT02522624|143032299|SUPERIORITY_OR_OTHER|||||||0.57|||||||Regression, Linear|||Controlling for Numeracy.||||0.57
71654635|NCT00518882|142826800|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.859||0.2764||95.0|-0.187|0.054|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.054|-0.187|0.2764
71654636|NCT00518882|142826800|SUPERIORITY_OR_OTHER||Mean|0.09|STANDARD_DEVIATION|0.89||0.1911||95.0|-0.043|0.216|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.216|-0.043|0.1911
71654637|NCT00518882|142826801|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.04||||0.4412||95.0|-0.15|0.06||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.06|-0.15|0.4412
71654638|NCT00518882|142826802|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.606||0.4746||95.0|-0.054|0.115|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.115|-0.054|0.4746
71654639|NCT00518882|142826802|SUPERIORITY_OR_OTHER||Mean|0.08|STANDARD_DEVIATION|0.72||0.1281||95.0|-0.024|0.188|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.188|-0.024|0.1281
71654640|NCT00518882|142826803|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|0.604|<|0.0001||95.0|-0.39|-0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.214|-0.390|<0.0001
71654641|NCT00518882|142826803|SUPERIORITY_OR_OTHER||Mean|-0.21|STANDARD_DEVIATION|0.647|<|0.0001||95.0|-0.303|-0.11|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.110|-0.303|<0.0001
71654642|NCT00518882|142826804|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0277||95.0|-0.13|-0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.01|-0.13|0.0277
71654643|NCT00518882|142826805|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.29||0.003||95.0|0.021|0.102|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.102|0.021|0.0030
71654644|NCT00518882|142826805|SUPERIORITY_OR_OTHER||Mean|0.03|STANDARD_DEVIATION|0.307||0.1452||95.0|-0.012|0.079|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.079|-0.012|0.1452
71654645|NCT00518882|142826806|SUPERIORITY_OR_OTHER||Mean|0.27|STANDARD_DEVIATION|0.306|<|0.0001||95.0|0.223|0.315|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.315|0.223|<0.0001
71654646|NCT00518882|142826806|SUPERIORITY_OR_OTHER||Mean|0.31|STANDARD_DEVIATION|0.346|<|0.0001||95.0|0.259|0.364|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.364|0.259|<0.0001
71826379|NCT04341298|143157225|SUPERIORITY|Null hypothesis is that proportion of headaches with light sensitivity experienced after 2 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||||0.028|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 2 hours modeled as a function of study arm, baseline pain score and headache medication use.||||||0.028
71654647|NCT00518882|142826807|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.01||||0.5105||95.0|-0.02|0.04||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.04|-0.02|0.5105
71654648|NCT00518882|142826808|SUPERIORITY_OR_OTHER||Mean|-0.01|STANDARD_DEVIATION|0.15||0.222||95.0|-0.034|0.008|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.008|-0.034|0.2220
71707372|NCT05058456|142932568|OTHER|The primary safety hypothesis is: H0: ΠS \> PGS vs. HA: ΠS ≤ PGS where ΠS is the proportion of patients who experience a MAE within 30 days of procedure and PGS is the Safety Performance Goal. All subjects in whom a Mini S IVL catheter was introduced into the vasculature will be included in the analysis (i.e., it is an intent-to-treat analysis). The hypothesis will be tested using a one-sided Exact Binomial Test at α=0.025.|||||<|0.025|||||||Fisher Exact|||||||<.025
71826380|NCT04341298|143157226|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Proportion of headaches with light sensitivity after 4 hours modeled as a function of study arm, baseline pain score and headache medication use.||Null hypothesis is that proportion of headaches with light sensitivity experienced after 4 hours is equivalent between study arms, after adjusting for baseline pain score and headache medication use.||||0.46
71707373|NCT05058456|142932569|OTHER|The primary effectiveness hypothesis is: H0: ΠE ≤ PGE vs. HA: ΠE \> PGE, where ΠE is the proportion of target lesions with technical success and PG is the effectiveness Performance Goal. One-sided statistical significance level of 0.025 = α. The hypothesis will be tested using a one-sided Exact Binomial Test.|||||<|0.025|||||||Fisher Exact|||||||<.025
71707374|NCT02933151|142932577|SUPERIORITY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.92|1.14|||||Reference group is usual care|||1.14|0.92|
71707375|NCT04392362|142932579|NON_INFERIORITY|The non-inferiority margin or delta was calculated as -0.12(-12%)|Risk Ratio (RR)|0.89||||0.8982|ONE_SIDED|95.0||||0.05 was the level of significance|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the AHA method is inferior to the SIM method but not lower than a pre calculated noninferiority delta of -0.12 (-12 %) and a 95% one sided confidence interval. Only 33 (instead of 151 for a power of 95%) patients could be enrolled with 25 in the SIM and 8 in the AHA arms, which resulted in an estimated power test of 59.08%.||||0.8982
71707376|NCT01428713|142932580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|536.4|STANDARD_ERROR_OF_MEAN|162.12||0.01||||||P value \< 0.05 is considered significant in this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for TA|||||0.01
71707377|NCT01428713|142932580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|430.6|STANDARD_ERROR_OF_MEAN|157.35||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for COCP|||||0.03
71707378|NCT01428713|142932580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|STANDARD_ERROR_OF_MEAN|5.08||0.03||||||P value \< 0.05 is considered significant for this study|Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for TA|||||0.03
71707379|NCT01428713|142932580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.75|STANDARD_ERROR_OF_MEAN|4.87||0.01|||||||Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP|||||0.01
71707380|NCT00871000|142932585|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.||2.7|-2.61|
71707381|NCT00871000|142932585|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.||2.7|-2.61|
71707382|NCT00871000|142932585|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.72||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.||2.72|-2.61|
71707383|NCT00871000|142932586|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.||2.7|-2.61|
71707384|NCT00871000|142932586|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference \[Tetravac Group minus Boostrix Polio Group\] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.||2.7|-2.61|
71707385|NCT01052428|142932602|SUPERIORITY_OR_OTHER|||||||0.4568||95.0|||||Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.4568
71764972|NCT02522624|143032300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.32|||<|0.001|TWO_SIDED|95.0|5.94|17.95||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||||17.95|5.94|<.001
71707386|NCT01052428|142932603|SUPERIORITY_OR_OTHER|||||||0.1967||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.1967
71654649|NCT00518882|142826808|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.141||0.7923||95.0|-0.018|0.024|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.024|-0.018|0.7923
71654650|NCT00518882|142826809|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.159||0.0254||95.0|-0.05|-0.003|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.003|-0.050|0.0254
71654651|NCT00518882|142826809|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.165||0.2244||95.0|-0.04|0.009|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.009|-0.040|0.2244
71654652|NCT00518882|142826810|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.18||||0.0485||95.0|-0.37|0.0||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.00|-0.37|0.0485
71654653|NCT00518882|142826811|SUPERIORITY_OR_OTHER||Mean|0.1|STANDARD_DEVIATION|0.82||0.1161||95.0|-0.02|0.21|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.21|-0.02|0.1161
71654654|NCT00518882|142826811|SUPERIORITY_OR_OTHER||Mean|0.0|STANDARD_DEVIATION|0.96||0.7888||95.0|-0.16|0.12|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.12|-0.16|0.7888
71654655|NCT00518882|142826812|SUPERIORITY_OR_OTHER||Mean|-0.3|STANDARD_DEVIATION|1.07||0.0003||95.0|-0.43|-0.13|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.13|-0.43|0.0003
71654656|NCT00518882|142826812|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|1.47||0.2078||95.0|-0.35|0.08|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||0.08|-0.35|0.2078
71654657|NCT00518882|142826813|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.07||||0.0014||95.0|-0.11|-0.03||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||-0.03|-0.11|0.0014
71654658|NCT00518882|142826814|SUPERIORITY_OR_OTHER||Mean|0.06|STANDARD_DEVIATION|0.269||0.0018||95.0|0.023|0.098|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.098|0.023|0.0018
71654659|NCT00518882|142826814|SUPERIORITY_OR_OTHER||Mean|0.01|STANDARD_DEVIATION|0.272||0.5499||95.0|-0.028|0.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.052|-0.028|0.5499
71654660|NCT00518882|142826815|SUPERIORITY_OR_OTHER||Mean|-0.1|STANDARD_DEVIATION|0.273|<|0.0001||95.0|-0.14|-0.062|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.062|-0.140|<0.0001
71654661|NCT00518882|142826815|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.302||0.0012||95.0|-0.118|-0.03|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.030|-0.118|0.0012
71654662|NCT00518882|142826816|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|-0.02||||0.1119||95.0|-0.05|0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.||0.01|-0.05|0.1119
71707387|NCT01052428|142932604|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.55
71654663|NCT00518882|142826817|SUPERIORITY_OR_OTHER||Mean|-0.02|STANDARD_DEVIATION|0.168||0.1342||95.0|-0.041|0.006|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||0.006|-0.041|0.1342
71654664|NCT00518882|142826817|SUPERIORITY_OR_OTHER||Mean|-0.03|STANDARD_DEVIATION|0.189||0.0344||95.0|-0.057|-0.002|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 - µ26 = 0 against HA: µ78 - µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.||-0.002|-0.057|0.0344
71654665|NCT00518882|142826818|SUPERIORITY_OR_OTHER||Mean|-0.08|STANDARD_DEVIATION|0.176|<|0.0001||95.0|-0.105|-0.056|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.056|-0.105|<0.0001
71654666|NCT00518882|142826818|SUPERIORITY_OR_OTHER||Mean|-0.07|STANDARD_DEVIATION|0.192|<|0.0001||95.0|-0.094|-0.038|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78- µ0=0 against HA: µ78 - µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.||-0.038|-0.094|<0.0001
71654667|NCT02696031|142826833|SUPERIORITY||Odds Ratio (OR)|1.72||||0.0197|TWO_SIDED|95.0|1.09|2.7||unadjusted p-value|Regression, Logistic|||week 16||2.70|1.09|0.0197
71654668|NCT02696031|142826833|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0146|TWO_SIDED|95.0|1.12|2.76||unadjusted p-value|Regression, Logistic|||week 16||2.76|1.12|0.0146
71654669|NCT02696031|142826834|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0017|TWO_SIDED|95.0|1.35|3.63||unadjusted p-value|Regression, Logistic|||week 52||3.63|1.35|0.0017
71654670|NCT02696031|142826834|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.36||unadjusted p-value|Regression, Logistic|||week 52||4.36|1.64|<.0001
71654671|NCT02696031|142826835|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0108|TWO_SIDED|95.0|1.14|2.74||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.74|1.14|0.0108
71654672|NCT02696031|142826835|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0087|TWO_SIDED|95.0|1.16|2.78||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.78|1.16|0.0087
71707388|NCT01052428|142932605|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.21
71654673|NCT02696031|142826835|SUPERIORITY|week 52|Odds Ratio (OR)|2.16||||0.0016|TWO_SIDED|95.0|1.34|3.49||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|3.49|1.34|0.0016
71654674|NCT02696031|142826835|SUPERIORITY|week 52|Median Difference (Net)|2.61|||<|0.0001|TWO_SIDED|95.0|1.62|4.19||unadjusted p-value|Regression, Linear||||Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|4.19|1.62|<.0001
71654675|NCT02696031|142826836|SUPERIORITY||Odds Ratio (OR)|1.6||||0.026|TWO_SIDED|95.0|1.06|2.43||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.43|1.06|0.0260
71654676|NCT02696031|142826836|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0149|TWO_SIDED|95.0|1.11|2.54||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight as a covariate.|2.54|1.11|0.0149
71654677|NCT02696031|142826837|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0005|TWO_SIDED|95.0|1.43|3.58||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|3.58|1.43|0.0005
71654678|NCT02696031|142826837|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0094|TWO_SIDED|95.0|1.16|2.94||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|2.94|1.16|0.0094
71654679|NCT02696031|142826838|SUPERIORITY||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|1.95|7.39||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.39|1.95|<.0001
71707389|NCT01052428|142932606|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.006
71707390|NCT01052428|142932607|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.16
71707391|NCT01052428|142932608|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)||||0.001
71707392|NCT03400787|142932609|SUPERIORITY|||||||0.0001||||||p\<0.025 indicates statistical significance.|t-test, 1 sided|||Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.||||0.0001
71707393|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.139||||0.145|TWO_SIDED|95.0|0.956|1.357|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.357|0.956|0.145
71707394|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.11||||0.298|TWO_SIDED|95.0|0.912|1.35|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.35|0.912|0.298
71826381|NCT01249092|143157270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-57.3|STANDARD_DEVIATION|62.1||0.001|TWO_SIDED|95.0|-88.2|-26.4||This study tested the hypothesis that treatment with pentoxifylline would result in a statistically significant change from baseline in the level of alkaline phosphatase.|Paired t-test|||A p-value \< 0.05 was considered statistically significant and all analyses were carried out using SAS version 9.2 (The SAS Institute, Cary, NC). Matched pairs t-test was used to compare the change in alkaline phosphatase from baseline. The efficacy of therapy was measured based on improvement in AP levels after therapy with PTX. AP levels at end of the study were compared with values at baseline by matched pairs t-test.||-26.4|-88.2|0.001
71826382|NCT01249092|143157271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.69|STANDARD_ERROR_OF_MEAN|8.66||0.5|TWO_SIDED|95.0|-24.14|8.68||Hypothesis tested if TIMP-1 levels after therapy with pentoxifylline changed significantly from baseline from baseline.|Paired t-test.|||Change from baseline in TIMP-1 levels was assessed by paired-t test. Distribution the variable values was assessed using normal probability plots. Matched pairs t-test was used to compare the change from baseline.||8.68|-24.14|0.5
71826383|NCT02657629|143157277|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71826384|NCT01466881|143157313|SUPERIORITY_OR_OTHER|||||||0.2316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided alpha level of 0.05||The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.||||0.2316
71826385|NCT01444287|143157322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.636|STANDARD_ERROR_OF_MEAN|0.2093||0.0035||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0035
71826386|NCT01444287|143157322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.743|STANDARD_ERROR_OF_MEAN|0.2093||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control - Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
71826387|NCT01444287|143157322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0275|STANDARD_ERROR_OF_MEAN|0.2093||0.8957||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8957
71826388|NCT01444287|143157323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0031||0.0692||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.0692
71826389|NCT01444287|143157323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0011|STANDARD_ERROR_OF_MEAN|0.0032||0.7301||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.7301
71826390|NCT01444287|143157323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0008|STANDARD_ERROR_OF_MEAN|0.0032||0.8055||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.8055
71826391|NCT01444287|143157324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0122|STANDARD_ERROR_OF_MEAN|0.1111||0.9127||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9127
71826392|NCT01444287|143157324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6864|STANDARD_ERROR_OF_MEAN|0.1098||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0000
71654680|NCT02696031|142826838|SUPERIORITY||Odds Ratio (OR)|3.64||||0.0001|TWO_SIDED|95.0|1.87|7.1||unadjusted p-value|Regression, Logistic|||week 16|Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNF-alpha status as factors and baseline weight as a covariate.|7.10|1.87|0.0001
71654681|NCT02696031|142826839|SUPERIORITY||LS Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.259||0.0041|TWO_SIDED|95.0|-1.26|-0.24||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.24|-1.26|0.0041
71654682|NCT02696031|142826839|SUPERIORITY||LS Mean|-0.64|STANDARD_ERROR_OF_MEAN|0.259||0.0143|TWO_SIDED|95.0|-1.15|-0.13||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.13|-1.15|0.0143
71654683|NCT02696031|142826840|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.58|4.07||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|4.07|1.58|0.0001
71654684|NCT02696031|142826840|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.51|3.89||unadjusted p-value|Regression, Logistic|||week 16|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.89|1.51|0.0002
71654685|NCT02696031|142826840|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0056|TWO_SIDED|95.0|1.22|3.24||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.24|1.22|0.0056
71654686|NCT02696031|142826840|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0005|TWO_SIDED|95.0|1.45|3.78||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders."|3.78|1.45|0.0005
71654687|NCT02696031|142826841|SUPERIORITY||LS Mean of treatment difference|-0.89|STANDARD_ERROR_OF_MEAN|0.256||0.0006|TWO_SIDED|95.0|-1.39|-0.38||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.38|-1.39|0.0006
71654688|NCT02696031|142826841|SUPERIORITY||LS Mean of Treatment Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.255||0.0002|TWO_SIDED|95.0|-1.47|-0.47||unadjusted p-value|mixed model repeated measures (MMRM)|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.47|-1.47|0.0002
71654689|NCT02696031|142826842|SUPERIORITY||LS Mean|-1.61|STANDARD_ERROR_OF_MEAN|0.478||0.0008|TWO_SIDED|95.0|-2.54|-0.67||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.67|-2.54|0.0008
71654690|NCT02696031|142826842|SUPERIORITY||LS Mean|-1.78|STANDARD_ERROR_OF_MEAN|0.479||0.0002|TWO_SIDED|95.0|-2.72|-0.84||unadjusted p-value|MMRM|||week 16|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|-0.84|-2.72|0.0002
71654691|NCT02696031|142826843|SUPERIORITY|||||||0.0012||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||0.0012
71654692|NCT02696031|142826843|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
71654693|NCT02696031|142826844|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0577|TWO_SIDED|95.0|0.98|3.45||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|3.45|0.98|0.0577
71654694|NCT02696031|142826844|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0003|TWO_SIDED|95.0|1.65|5.41||unadjusted p-value|Regression, Logistic|||week 52|"Odds ratio, 95% CI, and p-value were from a logistic regression model with treatment, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors and baseline weight and baseline score as covariates.~Missing responses for any reason were imputed as non-responders. Patients were considered as non-responders after treatment switch decision."|5.41|1.65|0.0003
71707395|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.178||||0.127|TWO_SIDED|95.0|0.955|1.452|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.452|0.955|0.127
71707396|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.117||||0.286|TWO_SIDED|95.0|0.911|1.37|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.37|0.911|0.286
71707397|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.179||||0.183|TWO_SIDED|95.0|0.925|1.504|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.504|0.925|0.183
71707398|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.2||||0.209|TWO_SIDED|95.0|0.903|1.595|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.595|0.903|0.209
71707399|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.144||||0.463|TWO_SIDED|95.0|0.799|1.638|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.638|0.799|0.463
71707400|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.331||||0.074|TWO_SIDED|95.0|0.972|1.822|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.822|0.972|0.074
71707401|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.169||||0.306|TWO_SIDED|95.0|0.867|1.577|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.577|0.867|0.306
71707402|NCT03850431|142932638|OTHER||Odds Ratio (OR)|1.15||||0.373|TWO_SIDED|95.0|0.845|1.565|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.565|0.845|0.373
71707403|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.923||||0.153|TWO_SIDED|95.0|0.826|1.03|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.03|0.826|0.153
71707404|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.911||||0.252|TWO_SIDED|95.0|0.777|1.068|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.068|0.777|0.252
71707405|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.941||||0.413|TWO_SIDED|95.0|0.815|1.088|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.088|0.815|0.413
71707406|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.946||||0.41|TWO_SIDED|95.0|0.83|1.079|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.079|0.83|0.41
71707407|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.887||||0.11|TWO_SIDED|95.0|0.766|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.766|0.11
71707408|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.833||||0.14|TWO_SIDED|95.0|0.654|1.062|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.062|0.654|0.14
71707409|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.882||||0.404|TWO_SIDED|95.0|0.657|1.184|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.184|0.657|0.404
71707410|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.743||||0.072|TWO_SIDED|95.0|0.538|1.027|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.027|0.538|0.072
71707411|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.778||||0.057|TWO_SIDED|95.0|0.6|1.008|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.008|0.6|0.057
71707412|NCT03850431|142932639|OTHER||Odds Ratio (OR)|0.932||||0.637|TWO_SIDED|95.0|0.697|1.247|||Regression, Logistic|Logistic regression with clustering for clinics and patients||||1.247|0.697|0.637
71707413|NCT01791205|142932669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.538||||0.1194|TWO_SIDED|95.0|0.65|19.33||The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.|Regression, Cox|||The relation between retention rate and DAS28 (\<2.6 vs \<3.2) was assayed with the Cox regression.||19.33|0.65|0.1194
71707414|NCT01791205|142932670|SUPERIORITY_OR_OTHER|||||||0.3895|||||||Regression, Cox|||||||0.3895
71707415|NCT01791205|142932671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.211||||0.49|TWO_SIDED|95.0|0.703|2.086|||Regression, Logistic|||||2.086|0.703|0.4900
71707416|NCT01791205|142932672|SUPERIORITY_OR_OTHER||Delta|-0.042||||0.6908|TWO_SIDED|95.0|-0.251|0.167|||t-test, 2 sided|||||0.167|-0.251|0.6908
71707417|NCT01791205|142932673|SUPERIORITY_OR_OTHER|||||||0.021|||||||Pearson's chi-squared test|||||||0.0210
71707418|NCT01546987|142932728|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|95.0|0.47|1.48||One-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that seventy events with five years of additional follow-up after early accrual closure provides 70% power (at one-sided alpha = 0.05) to detect a 40% reduction in the assumed rate control arm rate of is 0.08/year.||1.48|0.47|0.55
71707419|NCT01546987|142932729|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.27|TWO_SIDED|95.0|0.38|1.31||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.055 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 28% power (at two-sided alpha = 0.05) to detect a 33% reduction in failure rate.||1.31|0.38|0.27
71707420|NCT01546987|142932730|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.001|TWO_SIDED|95.0|1.54|3.4|||Log Rank||Reference level = ADT + RT arm|||3.40|1.54|<0.001
71707421|NCT01546987|142932731|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.33|3.13|||Log Rank|||||3.13|0.33|0.99
71707422|NCT01546987|142932732|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.48|TWO_SIDED|95.0|0.29|1.75||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT arm|Revised protocol due to early accrual closure (September 2014) computes that 5-year survival of 78% and annual hazard rate of 0.02 for ADT + RT arm, with five years of additional follow-up after early accrual closure provides 32% power (at two-sided alpha = 0.05) to detect a 50% reduction in failure rate.||1.75|0.29|0.48
71707423|NCT01546987|142932733|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.65|TWO_SIDED|95.0|0.45|1.63||Two-sided significance level = 0.05|Log Rank||Reference level = ADT + RT|||1.63|0.45|0.65
71707424|NCT01546987|142932735|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.76
71707425|NCT01546987|142932736|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||\[Bowel domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.44
71707426|NCT01546987|142932736|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||\[Urinary domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.13
71707427|NCT01546987|142932736|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||\[Sexual domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.50
71707428|NCT01546987|142932736|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||\[Hormonal domain\] One hundred thirty evaluable participants (arms combined), provides 81% power to detect a moderate effect size of 0.5 using a two-sample test of the difference in means with a two-sided type I error of 0.05.||||0.96
71707429|NCT01546987|142932747|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0104|TWO_SIDED|95.0|0.29|0.89|||Log Rank||Reference arm = ADT + RT arm|||0.89|0.29|0.0104
71707430|NCT02191397|142932755|NON_INFERIORITY|A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram.|Mean Difference (Final Values)|0.8||||0.139|TWO_SIDED|95.0|-0.27|1.94||Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.94|-0.27|0.139
71707431|NCT02191397|142932756|OTHER||Odds Ratio (OR)|0.85||||0.479|TWO_SIDED|95.0|0.55|1.33||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables.|GEE model|||||1.33|0.55|0.479
71707432|NCT02191397|142932757|OTHER||Odds Ratio (OR)|0.73||||0.129|TWO_SIDED|95.0|0.48|1.1||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.10|0.48|0.129
71707433|NCT02191397|142932758|OTHER||Odds Ratio (OR)|0.83||||0.354|TWO_SIDED|95.0|0.55|1.24||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.24|0.55|0.354
71707434|NCT02191397|142932759|OTHER||Odds Ratio (OR)|0.85||||0.489|TWO_SIDED|95.0|0.54|1.34||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model|||||1.34|0.54|0.489
71707435|NCT02191397|142932760|OTHER||Mean Difference (Final Values)|0.2||||0.627|TWO_SIDED|95.0|-0.7|1.16||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.16|-0.70|0.627
71707436|NCT02191397|142932760|OTHER||Mean Difference (Final Values)|1.4||||0.037|TWO_SIDED|95.0|0.08|2.66||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.66|0.08|0.037
71707437|NCT02191397|142932760|OTHER||Mean Difference (Final Values)|1.2||||0.143|TWO_SIDED|95.0|-0.4|2.78||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.78|-0.40|0.143
71764973|NCT02522624|143032300|SUPERIORITY_OR_OTHER|||||||0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).||||0.001
71707438|NCT02191397|142932760|OTHER||Mean Difference (Final Values)|0.8||||0.33|TWO_SIDED|95.0|-0.81|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.81|0.330
71707439|NCT02191397|142932760|OTHER||Mean Difference (Final Values)|0.9||||0.278|TWO_SIDED|95.0|-0.69|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||2.40|-0.69|0.278
71707440|NCT02191397|142932761|OTHER||Mean Difference (Final Values)|0.0||||0.579|TWO_SIDED|95.0|-0.09|0.16||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.16|-0.09|0.579
71707441|NCT02191397|142932761|OTHER||Mean Difference (Final Values)|0.1||||0.163|TWO_SIDED|95.0|-0.04|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.04|0.163
71764974|NCT02522624|143032300|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||Controlling for numeracy.||||0.46
71826393|NCT01444287|143157324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1705|STANDARD_ERROR_OF_MEAN|0.1098||0.1256||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.1256
71707442|NCT02191397|142932761|OTHER||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.34||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.34|0.00|0.050
71707443|NCT02191397|142932761|OTHER||Mean Difference (Final Values)|0.1||||0.337|TWO_SIDED|95.0|-0.09|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.26|-0.09|0.337
71707444|NCT02191397|142932761|OTHER||Mean Difference (Final Values)|0.0||||0.714|TWO_SIDED|95.0|-0.14|0.2||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.20|-0.14|0.714
71707445|NCT02191397|142932762|OTHER||Mean Difference (Final Values)|-0.2||||0.358|TWO_SIDED|95.0|-0.5|0.18||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.18|-0.50|0.358
71707446|NCT02191397|142932762|OTHER||Mean Difference (Final Values)|0.4||||0.081|TWO_SIDED|95.0|-0.04|0.75||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.75|-0.04|0.081
71707447|NCT02191397|142932762|OTHER||Mean Difference (Final Values)|0.5||||0.062|TWO_SIDED|95.0|-0.02|0.99||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.99|-0.02|0.062
71707448|NCT02191397|142932762|OTHER||Mean Difference (Final Values)|0.4||||0.118|TWO_SIDED|95.0|-0.1|0.85||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.85|-0.10|0.118
71707449|NCT02191397|142932762|OTHER||Mean Difference (Final Values)|0.3||||0.252|TWO_SIDED|95.0|-0.19|0.71||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.71|-0.19|0.252
71707450|NCT02191397|142932763|OTHER||Mean Difference (Final Values)|0.1||||0.573|TWO_SIDED|95.0|-0.2|0.35||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.20|0.573
71707451|NCT02191397|142932763|OTHER||Mean Difference (Final Values)|0.2||||0.209|TWO_SIDED|95.0|-0.13|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.13|0.209
71707452|NCT02191397|142932763|OTHER||Mean Difference (Final Values)|0.2||||0.427|TWO_SIDED|95.0|-0.25|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.58|-0.25|0.427
71707453|NCT02191397|142932763|OTHER||Mean Difference (Final Values)|0.0||||0.851|TWO_SIDED|95.0|-0.4|0.48||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.48|-0.40|0.851
71707454|NCT02191397|142932763|OTHER||Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|95.0|-0.25|0.66||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|-0.25|0.370
71707455|NCT02191397|142932764|OTHER||Mean Difference (Final Values)|0.1||||0.438|TWO_SIDED|95.0|-0.16|0.37||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.37|-0.16|0.438
71707456|NCT02191397|142932764|OTHER||Mean Difference (Final Values)|0.4||||0.014|TWO_SIDED|95.0|0.07|0.66||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.66|0.07|0.014
71707457|NCT02191397|142932764|OTHER||Mean Difference (Final Values)|0.2||||0.207|TWO_SIDED|95.0|-0.11|0.5||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.50|-0.11|0.207
71707458|NCT02191397|142932764|OTHER||Mean Difference (Final Values)|0.2||||0.137|TWO_SIDED|95.0|-0.07|0.54||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.54|-0.07|0.137
71707459|NCT02191397|142932764|OTHER||Mean Difference (Final Values)|0.2||||0.299|TWO_SIDED|95.0|-0.14|0.46||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.46|-0.14|0.299
71707460|NCT02191397|142932765|OTHER||Mean Difference (Final Values)|0.0||||0.804|TWO_SIDED|95.0|-0.1|0.13||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.13|-0.10|0.804
71826394|NCT01444287|143157325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|5.044||0.9892||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.||||0.9892
71707461|NCT02191397|142932765|OTHER||Mean Difference (Final Values)|0.1||||0.079|TWO_SIDED|95.0|-0.02|0.28||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.28|-0.02|0.079
71707462|NCT02191397|142932765|OTHER||Mean Difference (Final Values)|0.2||||0.036|TWO_SIDED|95.0|0.01|0.38||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.38|0.01|0.036
71707463|NCT02191397|142932765|OTHER||Mean Difference (Final Values)|0.1||||0.248|TWO_SIDED|95.0|-0.08|0.31||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.31|-0.08|0.248
71707464|NCT02191397|142932765|OTHER||Mean Difference (Final Values)|0.2||||0.11|TWO_SIDED|95.0|-0.04|0.35||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.35|-0.04|0.110
71707465|NCT02191397|142932766|OTHER||Odds Ratio, log|0.78||||0.545|TWO_SIDED|95.0|0.35|1.75||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.75|0.35|0.545
71707466|NCT02191397|142932766|OTHER||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.58|1.54||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.54|0.58|0.822
71707467|NCT02191397|142932766|OTHER||Odds Ratio (OR)|0.57||||0.007|TWO_SIDED|95.0|0.38|0.86||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||0.86|0.38|0.007
71707468|NCT02191397|142932766|OTHER||Odds Ratio (OR)|0.83||||0.417|TWO_SIDED|95.0|0.54|1.29||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.29|0.54|0.417
71707469|NCT02191397|142932766|OTHER||Odds Ratio (OR)|0.83||||0.485|TWO_SIDED|95.0|0.49|1.4||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.|||1.40|0.49|0.485
71707470|NCT01618708|142932845|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.07|||=|0.7462|TWO_SIDED|95.0|-0.38|0.52||Threshold for significance at 0.05 level|Mixed Models Analysis||Placebo vs Synvisc-One|Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).||0.52|-0.38|= 0.7462
71707471|NCT02554474|142932854|SUPERIORITY||Adjusted difference in mean change|9.4|||||TWO_SIDED|95.0|-0.5|19.3||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.||19.3|-0.5|
71826395|NCT01444287|143157325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|4.984||0.0007||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.||||0.0007
71707472|NCT02554474|142932855|SUPERIORITY||Adjusted difference in mean change|-10.4|||||TWO_SIDED|95.0|-53.4|32.6||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing sedentary time at 9 weeks (primary end point) between groups, adjusting for baseline sedentary time, diagnosis, and blocking.||32.6|-53.4|
71707473|NCT02554474|142932856|SUPERIORITY||Adjusted difference in mean change|-0.31|||||TWO_SIDED|95.0|-0.63|0.01||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in the Fatigue Severity Scale at 9 weeks (primary end point) between groups, adjusting for baseline fatigue score, diagnosis, and blocking.||0.01|-0.63|
71707474|NCT02554474|142932857|SUPERIORITY||Adjusted difference in mean change|-2.45|||||TWO_SIDED|95.0|-4.78|-0.13||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing pain at 9 weeks (primary end point) between groups, adjusting for pain score, diagnosis, and blocking.||-0.13|-4.78|
71707475|NCT02554474|142932858|SUPERIORITY||Adjusted difference in mean change|-0.22|||||TWO_SIDED|95.0|-1.78|1.35||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the PHQ-9 scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||1.35|-1.78|
71707476|NCT02554474|142932859|SUPERIORITY||Adjusted difference in mean change|1.58|||||TWO_SIDED|95.0|-1.02|4.18||||||We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing the Partners In Health Scale scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||4.18|-1.02|
71707477|NCT02554474|142932860|SUPERIORITY||Adjusted difference in mean change|0.05|||||TWO_SIDED|95.0|-0.05|0.16||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Work index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.16|-0.05|
71707478|NCT02554474|142932861|SUPERIORITY||Adjusted difference in mean change|0.0|||||TWO_SIDED|95.0|-0.37|0.37||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Sitting at Leisure index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.37|-0.37|
71707479|NCT02554474|142932862|SUPERIORITY||Adjusted difference in mean change|0.54|||||TWO_SIDED|95.0|0.08|0.99||||||We performed an intent-to-treat analysis. For the main comparison, analysis of covariance (ANCOVA) was used to estimate an adjusted mean difference comparing the Walking index scores at 9 weeks (primary end point) between groups, adjusting for baseline score, diagnosis, and blocking.||0.99|0.08|
71707480|NCT02770365|142932872|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.14|||||TWO_SIDED|90.0|-2.92|12.53|||Wald's method|||||12.53|-2.92|
71707481|NCT02770365|142932873|EQUIVALENCE|the proportion of subjects with treatment success based on the improvement of the Most Bothersome Symptom (MBS) of vulvo-vaginal atrophy at Day 8.|equivalence ratio|0.94||||0.05|TWO_SIDED|90.0|-12.35|4.31|||Wald's method|||||4.31|-12.35|0.05
71707482|NCT02991859|142932874|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FF E0 (Response of Placebo participants)|||19.39|9.39|
71707483|NCT02991859|142932874|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||Emax-Maximum Dose response|||25.40|8.21|
71707484|NCT02991859|142932874|OTHER||3 parameter Emax model|48.52|||||TWO_SIDED|95.0|18.21|129.32|||||ED50-Dose at which 50% of the maximum dose response reached (mcg)|||129.32|18.21|
71707485|NCT02991859|142932874|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||FP E0-Response of Placebo participants|||19.39|9.39|
71707486|NCT02991859|142932874|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||FP Emax-Maximum Dose response|||25.40|8.21|
71707487|NCT02991859|142932874|OTHER||3 parameter Emax model|1081.27|||||TWO_SIDED|95.0|448.0|2609.66|||||FP ED50-Dose at which 50% of the maximum dose response reached (mcg)|||2609.66|448.00|
71707488|NCT02991859|142932874|OTHER||3 parameter Emax model|13.5|||||TWO_SIDED|95.0|9.39|19.39|||||BUD E0-Response of Placebo participants|||19.39|9.39|
71707489|NCT02991859|142932874|OTHER||3 parameter Emax model|14.44|||||TWO_SIDED|95.0|8.21|25.4|||||BUD Emax-Maximum Dose response|||25.40|8.21|
71707490|NCT02991859|142932874|OTHER||3 parameter Emax model|1467.36|||||TWO_SIDED|95.0|546.51|3939.84|||||BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)|||3939.84|546.51|
71707491|NCT02991859|142932875|OTHER||Exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FF E0-Response of Placebo participants|||190.38|162.87|
71707492|NCT02991859|142932875|OTHER||exponential power-law model|899.99|||||TWO_SIDED|95.0|698.36|1101.62|||||FF ED50 Dose at which 50% of the maximum dose response reached|||1101.62|698.36|
71707493|NCT02991859|142932875|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||FP E0-Response of Placebo participants|||190.38|162.87|
71707494|NCT02991859|142932875|OTHER||exponential power-law model|1986.05|||||TWO_SIDED|95.0|1574.7|2397.39|||||FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2397.39|1574.70|
71707495|NCT02991859|142932875|OTHER||exponential power-law model|176.09|||||TWO_SIDED|95.0|162.87|190.38|||||BUD E0 - Response of Placebo participants|||190.38|162.87|
71707496|NCT02991859|142932875|OTHER||exponential power-law model|1927.42|||||TWO_SIDED|95.0|1698.47|2156.37|||||BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)|||2156.37|1698.47|
71707497|NCT02991859|142932876|OTHER||Emax Model|289.73|||||TWO_SIDED|95.0|224.82|354.64|||||ED20 Cortisol Suppression 0-24 Hours Weighted Mean|||354.64|224.82|
71707498|NCT02991859|142932876|OTHER||Emax Model|194.09|||||TWO_SIDED|95.0|72.82|517.28|||||ED80 for AMP PC20|||517.28|72.82|
71707499|NCT02991859|142932877|OTHER||Emax Model|639.36|||||TWO_SIDED|95.0|506.94|771.79|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||771.79|506.94|
71707500|NCT02991859|142932877|OTHER||Emax Model|4325.07|||||TWO_SIDED|95.0|1792.02|10438.64|||||ED80 for AMP PC20|||10438.64|1792.02|
71707501|NCT02991859|142932878|OTHER||Emax Model|620.49|||||TWO_SIDED|95.0|546.79|694.2|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean|||694.20|546.79|
71707502|NCT02991859|142932878|OTHER||Emax Model|5869.45|||||TWO_SIDED|95.0|2186.03|15759.35|||||ED80 for AMP PC20|||15759.35|2186.03|
71707503|NCT04223687|142932942|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.01
71707504|NCT04223687|142932943|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|t-test, 2 sided|||||||<0.01
71764975|NCT00109590|143032317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.||||0.009
71707505|NCT04223687|142932944|SUPERIORITY|||||||0.03||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.03
71707506|NCT04223687|142932945|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||0.37
71707507|NCT04223687|142932946|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71707508|NCT04223687|142932947|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71707509|NCT04223687|142932948|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71707510|NCT04223687|142932949|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Chi-squared|||||||<0.001
71707511|NCT04223687|142932950|SUPERIORITY|||||||0.06||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.06
71707512|NCT04223687|142932951|SUPERIORITY|||||||0.37||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.37
71707513|NCT04223687|142932952|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71707514|NCT04223687|142932953|SUPERIORITY|||||||0.42||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.42
71707515|NCT04223687|142932954|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.13
71707516|NCT04223687|142932955|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71707517|NCT00425854|142932959|SUPERIORITY_OR_OTHER||Maximum Likelihood|0.048|||||TWO_SIDED|95.0|0.001|0.238|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI.|||0.238|0.001|
71707518|NCT00425854|142932964|SUPERIORITY_OR_OTHER||Clinical benefit rate|0.1|||||TWO_SIDED|95.0|0.02|0.27|||Maxium Likelihood||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI.|||0.27|0.02|
71707519|NCT02057666|142932986|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.406||||0.027|TWO_SIDED|95.0|0.182|0.903|||Log Rank|Stratified as per randomisation.|Stratified as per randomisation.|||0.903|0.182|0.027
71707520|NCT02057666|142932987|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.465||||0.448|TWO_SIDED|95.0|0.065|3.355|||Log Rank|||||3.355|0.065|0.448
71707521|NCT00498485|142933001|SUPERIORITY_OR_OTHER||||||<|0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.||||<0.04
71707522|NCT01539525|142933003|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.118|-0.038|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the linear effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.038|-0.118|<0.001
71707523|NCT01539525|142933003|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.066|TWO_SIDED|95.0|-0.0004|0.011|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the quadratic effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.011|-0.0004|0.066
71707524|NCT01539525|142933003|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.034||0.038|TWO_SIDED|95.0|-0.151|-0.004||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.004|-0.151|0.038
71707525|NCT01539525|142933003|SUPERIORITY_OR_OTHER||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.034||0.008|TWO_SIDED|95.0|-0.157|-0.023||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||-0.023|-0.157|0.008
71764976|NCT00109590|143032317|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P\<0.05.|Wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum||||0.048
71707526|NCT01539525|142933003|SUPERIORITY_OR_OTHER||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.005||0.031|TWO_SIDED|95.0|0.001|0.022||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.022|0.001|0.031
71707527|NCT01539525|142933003|SUPERIORITY_OR_OTHER||Slope|0.012|STANDARD_ERROR_OF_MEAN|0.0005||0.01|TWO_SIDED|95.0|0.002|0.021||P-value adjusted for multiple comparisons using Holm's step-down multiple testing procedure. The a priori threshold for statistical significance was p \< 0.025.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.||0.021|0.002|0.010
71707528|NCT01539525|142933004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.81|TWO_SIDED|95.0|0.559|1.551|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual|||1.551|0.559|0.810
71654695|NCT02696031|142826845|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance|0.84|0.58|0.0002
71654696|NCT02696031|142826845|SUPERIORITY||Relative Treatment Effect|0.7||||0.0002||95.0|0.58|0.84||unadjusted p-value|MMRM|||week 16|Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value were from mixed-effect model repeated measures (MMRM) with treatment, visit, stratification factor and TNFi status as factors, log(e) baseline and weight as covariates, treatment by visit and log(e) baseline by visit as interaction terms and an unstructured covariance structure.|0.84|0.58|0.0002
71654697|NCT02696031|142826846|SUPERIORITY||LS Mean of Treatment Difference|2.77|STANDARD_ERROR_OF_MEAN|0.799||0.0006|TWO_SIDED|95.0|1.2|4.34||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.34|1.20|0.0006
71654698|NCT02696031|142826846|SUPERIORITY||LS Mean of Treatment Difference|2.64|STANDARD_ERROR_OF_MEAN|0.803||0.0011|TWO_SIDED|95.0|1.06|4.22||unadjusted p-value|ANCOVA|||week 16|LS Mean, 95% CI, and p-value were from a mixed model repeated measures (MMRM) with treatment group, analysis visit, stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates, treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure.|4.22|1.06|0.0011
71654699|NCT02696031|142826847|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
71654700|NCT02696031|142826847|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|ANCOVA|||week 16|"LS Mean, 95% CI, and p-value were from an ANCOVA model with treatment group and stratification factor (CRP+/MRI+, CRP+/MRI-, CRP-/MRI+) and TNFi status as factors, weight and baseline score as covariates.~Missing data were imputed using multiple imputation (MI, MAR assumption) prior to running ANCOVA."|||<0.0001
71654701|NCT02696031|142826848|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
71654702|NCT02696031|142826848|SUPERIORITY||||||<|0.0001||||||unadjusted p-value|Wilcoxon (Mann-Whitney)|The endpoint was analyzed by composite estimand strategy. Extreme unfavorable value is assigned for patients with treatment escape or missing data.||||||<.0001
71654703|NCT01338987|142826857|OTHER|||||||0.0075|||||||Wilcoxon's rank sum test|||||||0.0075
71654704|NCT02480582|142826863|SUPERIORITY_OR_OTHER||||||<|0.01||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||||||<0.01
71654705|NCT02480582|142826864|SUPERIORITY_OR_OTHER||||||<|0.05||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in wanting for high fat foods between almonds, cheese savouries and no food.||||||<0.05
71654706|NCT02480582|142826865|SUPERIORITY_OR_OTHER||||||<|0.001||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in hunger AUC between almonds, cheese savouries and no food.||||||<0.001
71654707|NCT02480582|142826866|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||"Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food."||||<0.05
71707529|NCT01539525|142933004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.99|TWO_SIDED|95.0|0.579|1.617|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual|||1.617|0.579|0.990
71707530|NCT01539525|142933005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.258||||0.465|TWO_SIDED|95.0|0.409|3.871|||Regression, Logistic|adjusted for stratifying variables- primary drug and pregnancy status|odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual|||3.871|0.409|0.465
71654708|NCT03856593|142826894|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.2|-0.07|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly MME post-letter in the Outcome Measure Data table.|Please note that 10% of means in the pre-intervention period were trimmed to remove outliers.||-0.07|-0.20|<0.05
71654709|NCT03856593|142826895|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|95.0|-0.15|-0.02|||Mixed Models Analysis||This is the interaction coefficient for the difference-in-difference in average weekly MME pre-to-post letter between study arms. It was used to acquire the estimated average weekly VME post-letter in the Outcome Measure Data table.|||-0.02|-0.15|<0.05
71654710|NCT03179163|142826936|OTHER||Mean Difference (Net)|0.01|||=|0.01|TWO_SIDED||||||ANOVA|||A priori power analysis (power = 0.80,a= 0.05) confirmed a sample size of n= 10 was needed to determine a meaningful difference of 10% in the (flux/MAP)\*logAch(mol/L) . All data were analyzed with repeated-measures ANOVA . When appropriate, post hoc Tukey-Kramer corrections were applied to correct for multiple comparisons. Significance was set a priori at a\<0.05.||||=0.01
71654711|NCT00775684|142826939|SUPERIORITY||||||=|0.1|||||||t-test, 2 sided|||Student t test||||=0.1
71654712|NCT00775684|142826939|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Repeated measure (baseline and 6 months)||||< 0.05
71654713|NCT00775684|142826940|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||Within group changes over 6 months (delta= final - baseline) were compared.||||>0.1
71654714|NCT00775684|142826941|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||To determine if exenatide or sitagliptin induced significant changes from baseline, the change for each measure (Δ = final - baseline) for each group was compared with the change in the glimepiride group using independent Student t tests||||>0.1
71654715|NCT00775684|142826942|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
71654716|NCT01277718|142826944|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|111.0|||||TWO_SIDED|90.0|98.02|124.99|||||LS mean was calculated from Analysis of variance (ANOVA). Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124.99|98.02|
71654717|NCT01277718|142826944|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.2|||||TWO_SIDED|90.0|85.06|108.77|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||108.77|85.06|
71654718|NCT01277718|142826944|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|106.0|||||TWO_SIDED|90.0|94.53|119.91|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||119.91|94.53|
71654719|NCT01277718|142826945|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|100.0|||||TWO_SIDED|90.0|85.09|118.03|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||118.03|85.09|
71654720|NCT01277718|142826945|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.7|||||TWO_SIDED|90.0|72.51|101.33|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.33|72.51|
71654721|NCT01277718|142826945|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|85.9|||||TWO_SIDED|90.0|72.94|101.17|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||101.17|72.94|
71654722|NCT02858726|142826991|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-2.8|<0.001
71654723|NCT02858726|142826991|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.107|TWO_SIDED|95.0|-1.9|0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||0.2|-1.9|0.107
71654724|NCT02858726|142826991|SUPERIORITY||Median Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.5||0.019|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.2|-2.3|0.019
71654725|NCT02858726|142826992|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-16.0|-4.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-4.8|-16.0|<0.001
71654726|NCT02858726|142826992|SUPERIORITY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|3.0||0.016|TWO_SIDED|95.0|-13.1|-1.4|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-1.4|-13.1|0.016
71654727|NCT02858726|142826992|SUPERIORITY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|95.0|-12.8|-0.8|||Mixed Models Analysis|MMRM with effects for treatment, visit, treatment by visit interaction, and covariates for prior anti-itch medication usage and baseline score.||||-0.8|-12.8|0.026
71654728|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.01||||||95.0|-2.87|-1.14|||||Mean (Day 8 - baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.14|-2.87|
71654729|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||||95.0|-3.49|-1.8|||||Mean (Day 8 - baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.80|-3.49|
71654730|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||||95.0|-3.9|-1.9|||||Mean (Day 8 - baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.90|-3.90|
71826396|NCT01444287|143157325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|4.984||0.003||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.||||0.0030
71826397|NCT01970943|143157371|OTHER||Mean Difference (Final Values)|0.6078||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71826398|NCT01970943|143157373|OTHER||Mean Difference (Final Values)|0.037786||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
71654731|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.38||||||95.0|-4.59|-2.17|||||Mean (Day 8 - baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.17|-4.59|
71654732|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73||||||95.0|-5.15|-4.31|||||Mean (Day 8 - baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 - baseline) HCV RNA for placebo|||-4.31|-5.15|
71654733|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.93||||||95.0|-2.68|-1.18|||||Mean (Day 8 - baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-1.18|-2.68|
71707531|NCT01539525|142933005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.749||||0.49|TWO_SIDED|95.0|0.205|2.732|||Regression, Logistic||Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual|||2.732|0.205|0.490
71654734|NCT00518622|142827002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||||95.0|-2.78|-2.13|||||Mean (Day 8 - baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 - baseline) HCV RNA for placebo|||-2.13|-2.78|
71654735|NCT02011113|142827027|SUPERIORITY_OR_OTHER|||||||0.0027||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)|Binomial test for dichotomized response|||||||0.0027
71654736|NCT02274844|142827038|SUPERIORITY|The outcomes were all continuous or ordinal measures, thus unadjusted hypothesis tests used t-tests or the Wilcoxon-Mann-Whitney test, as appropriate, and statistical modeling used linear regression. ANCOVA was used to adjust for baseline covariates with imbalance across treatment arms (race) and baseline values of the measures.|Mean Difference (Final Values)|-0.09||||0.22|TWO_SIDED|95.0|-0.23|0.05||The main hypotheses tested were that intervention participants would have higher medication adherence and significantly greater improvement in A1c, BP, LDL-C, and measures of quality of life, and self-efficacy compared to control participants.|ANCOVA|||The study was powered to detect clinically meaningful differences in physiologic risk factors; it had four primary outcomes.Power estimates accounted for clustering of patients within towns, using a variance inflation factor, conservatively estimating power for ICC=0.01-0.05. Process measures were selected to understand which aspects of the intervention were particularly effective, assessing both program satisfaction and peer coach effectiveness.||0.05|-0.23|0.22
71707532|NCT01712074|142933007|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.695|STANDARD_ERROR_OF_MEAN|0.8697||0.4256|TWO_SIDED|80.0|-0.424|1.814|||Mixed Models Analysis|||||1.814|-0.424|0.4256
71707533|NCT01712074|142933008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.194|STANDARD_ERROR_OF_MEAN|1.7149||0.2027|TWO_SIDED|80.0|-0.013|4.401|||Mixed Models Analysis|||||4.401|-0.013|0.2027
71707534|NCT02474901|142933033|EQUIVALENCE|Looked for statistically-significant difference in numbers of adverse events between the two groups, used a p-value of 0.05 as the cutoff value for significance.|||||<|0.05|||||||Chi-squared, Corrected|Groups were compared with Yates-corrected chi-square test or Fisher exact test for binary or categorical variables.||||||<0.05
71707535|NCT01044693|142933041|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||0.036
71707536|NCT01044693|142933041|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||<0.001
71707537|NCT01044693|142933041|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.||||>0.05
71707538|NCT01044693|142933042|SUPERIORITY_OR_OTHER|||||||0.607|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.607
71707539|NCT01044693|142933043|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.||||0.597
71707540|NCT01044693|142933044|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.||||0.996
71707541|NCT02792257|142933057|SUPERIORITY||Difference in slopes|-0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.328|-0.152|||Regression, Linear||standard error NOT standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||-0.152|-1.328|.015
71707542|NCT02792257|142933058|SUPERIORITY||Difference in slopes|-1.26|STANDARD_ERROR_OF_MEAN|0.75||0.094|TWO_SIDED|95.0|-2.73|0.21|||Regression, Linear||standard error not standard error of the mean|Efficacy is assessed by fitting a longitudinal linear GEE model with the co primary outcomes and with time, treatment arm, and their interaction. Analyses are adjusted for site and for use of antidepressants and antipsychotics at baseline. The treatment by week interaction is the coefficient of interest and represents the difference in change in outcome per week between the two arms.||0.21|-2.73|.094
71826399|NCT02469064|143157385|OTHER||Hazard Ratio (HR)|0.82||||0.84|TWO_SIDED|95.0|0.55|1.2|||Mann Whitneey||Univariate analysis of the probability of extubation was performed using Kaplan-Meir survival analysis and the logrank test.The multivariate analysis was performed by cox regression, a simple model was performed and a final model.|||1.20|0.55|0.84
71826400|NCT02469064|143157386|OTHER||Slope|0.46||||0.48|TWO_SIDED|95.0|-3.75|4.78|||t-test, 2 sided||The slope shows the difference between the means of the change in the MIP of the group that received the experimental treatment and the group that received the conventional treatment|||4.78|-3.75|0.48
71654737|NCT00468728|142827067|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|6.8||||||H0: C(OPT-80) - C(VAN) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||6.8|-4.8|
71654738|NCT00468728|142827068|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-14.4|||<|0.001|TWO_SIDED|95.0|-21.6|-7.0|||Chi-squared|||||-7.0|-21.6|<0.001
71654739|NCT00468728|142827069|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.4||||0.001||95.0|5.4|21.1|||Chi-squared|||||21.1|5.4|0.001
71654740|NCT01517659|142827089|OTHER||Mean Difference (Final Values)|2.61|STANDARD_DEVIATION|2.29|||TWO_SIDED|95.0|2.23|3.27||||||||3.27|2.23|
71654741|NCT02712333|142827090|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|7.53|||<|0.05|TWO_SIDED|95.0|4.65|10.41||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)||10.41|4.65|<0.05
71654742|NCT02712333|142827090|SUPERIORITY_OR_OTHER||fold change|1.33|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71654743|NCT02712333|142827091|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|3.69|||<|0.01|TWO_SIDED|95.0|1.85|5.54||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum cortisone levels by treatment (intervention group vs control group)||5.54|1.85|<0.01
71654744|NCT02712333|142827091|SUPERIORITY_OR_OTHER||fold change|1.18|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71654745|NCT02712333|142827092|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|5.17|||<|0.01|TWO_SIDED|95.0|3.21|7.14||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum epinephrine levels by treatment (intervention group vs control group)||7.14|3.21|<0.01
71654746|NCT02712333|142827092|SUPERIORITY_OR_OTHER||fold change|1.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71654747|NCT02712333|142827093|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|11.28|||<|0.01|TWO_SIDED|95.0|7.37|15.21||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)||15.21|7.37|<0.01
71654748|NCT02712333|142827093|SUPERIORITY_OR_OTHER||fold change|1.57|||<|0.01|TWO_SIDED||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group|||||<0.01
71654749|NCT02712333|142827094|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.84|||<|0.01|TWO_SIDED|95.0|0.09|1.59|||Mixed Models Analysis|||we analyzed the serum SBP levels by treatment (intervention group vs control group)||1.59|0.09|<0.01
71654750|NCT02712333|142827095|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|0.31|||>|0.05|TWO_SIDED|95.0|-1.59|0.96|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||0.96|-1.59|>0.05
71654751|NCT02712333|142827096|SUPERIORITY_OR_OTHER||% increase per 10μg/m3 increase of PM2.5|1.24|||>|0.05|TWO_SIDED|95.0|-1.14|3.63|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)||3.63|-1.14|>0.05
71654752|NCT03463993|142827097|SUPERIORITY|||||||0.549||||||The p-value above is the calculated P value based on hematocrit.|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.549
71654753|NCT03463993|142827097|SUPERIORITY|||||||0.138||||||This is the calculated p-value based on hemoglobin .|Chi-squared|||The null hypothesis was that intravenous Tranexamic Acid (TXA)10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section||||0.138
71654754|NCT03463993|142827098|SUPERIORITY|||||||0.789||||||0.789 is the calculated p-value for visually estimated blood loss: Visually estimated blood loss (ml): Group A mean 483.73 (standard deviation182.56); Group B 479.61 (139.49); p-value 0.789|t-test, 2 sided|||||||0.789
71654755|NCT03463993|142827098|SUPERIORITY|||||||0.968||||||0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968|t-test, 2 sided|||||||0.968
71654756|NCT03463993|142827098|SUPERIORITY|||||||0.447||||||Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447|t-test, 2 sided|||||||0.447
71654757|NCT03463993|142827099|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71654758|NCT03463993|142827100|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71654759|NCT05528861|142827127|SUPERIORITY||LSM Difference from Placebo|0.5|STANDARD_ERROR_OF_MEAN|2.1||0.8174|TWO_SIDED|95.0|-3.6|4.5|||ANCOVA|||||4.5|-3.6|0.8174
71654760|NCT05528861|142827128|SUPERIORITY||LSM Difference from Placebo|0.6|STANDARD_ERROR_OF_MEAN|1.1||0.5857|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||||2.8|-1.6|0.5857
71654761|NCT05528861|142827129|SUPERIORITY||LSM Difference from Placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9633|TWO_SIDED|95.0|-2.2|2.1|||Mixed Models Analysis|||||2.1|-2.2|0.9633
71654762|NCT05528861|142827130|SUPERIORITY||Risk Difference (RD)|6.25||||0.1201|TWO_SIDED|95.0|-11.4|23.78|||Fisher Exact|||||23.78|-11.40|0.1201
71654763|NCT01602172|142827133|EQUIVALENCE|Results of the regression models were used to reject null hypotheses of equivalence with p-values of comparisons across groups in changes in alcohol related measures using p-values \< 0.05 as significant.||||||0.05||||||First, significance of the regression model was viewed. When the overall model was significant, tests of the co-efficients were viewed. Primary effects of interest were the treatment group X time interactions.|Mixed Models Analysis|||Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).||||.05
71764977|NCT04672954|143032330|OTHER||Ratio|1.29||||0.3941|TWO_SIDED|90.0|0.78|2.13|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.34|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.13|0.78|0.3941
71764978|NCT04672954|143032330|OTHER||Ratio|1.66||||0.1089|TWO_SIDED|90.0|0.99|2.79|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.35|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.79|0.99|0.1089
71764979|NCT04672954|143032330|OTHER||Ratio|1.14||||0.6308|TWO_SIDED|90.0|0.71|1.85|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.32|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||1.85|0.71|0.6308
71764980|NCT04672954|143032330|OTHER||Ratio|1.75||||0.069|TWO_SIDED|90.0|1.06|2.89|||ANCOVA||Ratio = BI / Placebo. Geometric standard error = 1.33|The difference between the expected means for ln(T) - ln(R) was estimated by the difference in the corresponding least square means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were back-transformed to the original scale to give the point estimator and interval estimates.||2.89|1.06|0.0690
71826401|NCT02155829|143157387|SUPERIORITY|||||||0.442|||||||ANCOVA|ANCOVA covariate included site.||||||0.442
71826402|NCT02155829|143157388|SUPERIORITY|||||||0.994|||||||ANCOVA|ANCOVA covariate included site.||||||0.994
71654764|NCT01843348|142827234|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|Least square mean|-9.35|||<|0.0001|TWO_SIDED|95.0|-13.82|-4.88|||ANOVA|||The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin||-4.88|-13.82|<0.0001
71654765|NCT01843348|142827234|NON_INFERIORITY_OR_EQUIVALENCE|The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|Least squares mean|-5.56||||0.0067|TWO_SIDED|95.0|-9.56|-1.55||Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|ANOVA|||||-1.55|-9.56|0.0067
71654766|NCT01843348|142827235|SUPERIORITY_OR_OTHER||Point estimate|0.032|||||TWO_SIDED|95.0|-0.029|0.093||||||TAC+Certican - TAC+MPA - difference between groups||0.093|-0.029|
71654767|NCT01843348|142827235|SUPERIORITY_OR_OTHER||Point estimate|0.149|||||TWO_SIDED|95.0|0.076|0.221||||||CycA+Certican -Tac+MPA - difference between groups||0.221|0.076|
71654768|NCT01843348|142827239|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.028|||<|0.001|TWO_SIDED|95.0|-0.032|0.087|||Pearson's chi-square test|||BPAR - treatment differences at Month 12||0.087|-0.032|< 0.001
71654769|NCT02994355|142827260|SUPERIORITY||Prevalence rate ratio|1.33|||<|0.05|TWO_SIDED|95.0|1.16|1.52|||Poisson Regression|||||1.52|1.16|<0.05
71654770|NCT02994355|142827261|SUPERIORITY||Prevalence rate ratio|1.27|||<|0.05|TWO_SIDED|95.0|1.15|1.3|||Poisson regression|||||1.30|1.15|<0.05
71654771|NCT02994355|142827262|SUPERIORITY||Prevalence rate ratio|3.23|||<|0.05|TWO_SIDED|95.0|2.29|4.55|||Poisson regression|||||4.55|2.29|<0.05
71654772|NCT03050918|142827267|SUPERIORITY|||||||0.05||||||we used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
71654773|NCT03050918|142827268|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71654774|NCT03050918|142827268|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||.05
71654775|NCT03050918|142827269|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71654776|NCT03050918|142827269|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
71654777|NCT03050918|142827270|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||.05
71654778|NCT03050918|142827271|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)|||||||0.05
71654779|NCT03050918|142827272|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71654780|NCT03050918|142827274|SUPERIORITY|||||||0.05||||||We used the O'Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared|||||||0.05
71654781|NCT00430950|142827328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.2648||95.0|-1.51|0.42|||ANCOVA|||"The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.~Significance level alpha = 5%. Power = 80%.~The following statistical superiority hypothesis was tested:~Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg"||0.42|-1.51|0.2648
71654782|NCT00430950|142827329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.4246||95.0|-1.26|0.53|||ANCOVA|||||0.53|-1.26|0.4246
71886586|NCT00584233|143293485|NON_INFERIORITY|The statistical test will be to assess non-inferiority. The non-inferiority margin is -0.04 in AUC. Key parameters are the number of participating patients, the number of radiologists reading the images in the study. Power analysis was conducted using the standard simulation from the ROC literature (Roe and Metz, Academic Radiology 1997). With a total of 100 participating patients and 4 participating readers, we achieve a power \>80% with a non-inferiority margin of -0.04.|Obuchowski Rockette methodology|0.05||||0.05|TWO_SIDED|95.0|0.025|0.975|||Obuchowski Rockette|||The analysis is intended to evaluate non-inferiority in observer performance between CE-bCT and CE-bMRI as assessed by the area under the ROC curve (AUC). The null hypothesis is that the observed difference in average AUC for CE-bCT and CE-bMRI will be outside of a non-inferiority margin of -0.04. See below for details of the power analyses.||.975|.025|0.05
71707543|NCT02792257|142933059|SUPERIORITY||Incident rate ratio|1.14|STANDARD_ERROR_OF_MEAN|0.26||0.57|TWO_SIDED|95.0|0.73|1.79|||Regression, Logistic|The original analytic plan called for a logistic regression of ever/never SAE as a function of treatment assignment.|not standard error of the mean just standard error.|||1.79|0.73|.57
71707544|NCT00553475|142933060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0075||95.0|-1.09|-0.17|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.09|0.0075
71707545|NCT00553475|142933060|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0254||95.0|-1.39|-0.09|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.09|-1.39|0.0254
71707546|NCT00553475|142933061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28||||0.8731||95.0|-3.67|3.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.12|-3.67|0.8731
71707547|NCT00553475|142933061|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.16||||0.6337||95.0|-3.62|5.94|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.94|-3.62|0.6337
71707548|NCT00553475|142933062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1||||0.4398||95.0|-7.44|3.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.24|-7.44|0.4398
71707549|NCT00553475|142933062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.9153||95.0|-7.96|7.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.14|-7.96|0.9153
71707550|NCT00553475|142933063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.4873||95.0|-2.75|5.76|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.76|-2.75|0.4873
71707551|NCT00553475|142933063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.56||||0.4008||95.0|-3.42|8.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.53|-3.42|0.4008
71707552|NCT00553475|142933064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.5372||95.0|-2.13|4.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.09|-2.13|0.5372
71707553|NCT00553475|142933064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.09||||0.348||95.0|-2.29|6.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.47|-2.29|0.3480
71707554|NCT00553475|142933065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.06||||0.0544||95.0|-0.1|10.21|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.21|-0.10|0.0544
71707555|NCT00553475|142933065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.15||||0.0278||95.0|0.89|15.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.42|0.89|0.0278
71707556|NCT00553475|142933066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92||||0.7394||95.0|-4.52|6.37|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.37|-4.52|0.7394
71707557|NCT00553475|142933066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.22||||0.5712||95.0|-5.49|9.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.93|-5.49|0.5712
71707558|NCT00553475|142933067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0058||95.0|-1.14|-0.19|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.0058
71707559|NCT00553475|142933067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0333||95.0|-1.23|-0.05|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.23|0.0333
71707560|NCT00553475|142933068|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.153
71707561|NCT00553475|142933068|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.||||0.059
71707562|NCT00553475|142933069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.0287||95.0|-0.82|-0.05|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-0.82|0.0287
71654783|NCT00430950|142827330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7019||95.0|-1.84|1.24|||ANCOVA||refers to 8 week change; from week 8 to week 16|||1.24|-1.84|0.7019
71707563|NCT00553475|142933069|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.75||||0.0073||95.0|-1.29|-0.2|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.20|-1.29|0.0073
71707564|NCT00553475|142933070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0021||95.0|-1.0|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.00|0.0021
71707565|NCT00553475|142933070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|||<|0.0001||95.0|-1.78|-0.69|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.69|-1.78|<0.0001
71707566|NCT00553475|142933071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0026||95.0|-0.99|-0.21|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.21|-0.99|0.0026
71707567|NCT00553475|142933071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.13|||<|0.0001||95.0|-1.69|-0.58|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.58|-1.69|<0.0001
71707568|NCT00553475|142933072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0012||95.0|-1.03|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.03|0.0012
71707569|NCT00553475|142933072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||<|0.0001||95.0|-1.67|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.67|<0.0001
71707570|NCT00553475|142933073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0011||95.0|-1.04|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.04|0.0011
71707571|NCT00553475|142933073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|||<|0.0001||95.0|-1.72|-0.6|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.60|-1.72|<0.0001
71707572|NCT00553475|142933074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|||<|0.0001||95.0|-1.18|-0.4|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.40|-1.18|<0.0001
71707573|NCT00553475|142933074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||<|0.0001||95.0|-1.68|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.68|<0.0001
71707574|NCT00553475|142933075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
71654784|NCT00430950|142827330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7328||95.0|-1.71|1.21|||ANCOVA||refers to 4 week change; from week 8 to week 12|||1.21|-1.71|0.7328
71654785|NCT00430950|142827331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0016||95.0|-2.58|-0.6|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.60|-2.58|0.0016
71654786|NCT00430950|142827331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031||95.0|-2.61|-0.53|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.53|-2.61|0.0031
71654787|NCT00430950|142827331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0073||95.0|-2.58|-0.4|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)|||-0.40|-2.58|0.0073
71654788|NCT00430950|142827331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0021||95.0|-3.71|-0.82|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.82|-3.71|0.0021
71654789|NCT00430950|142827331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0031||95.0|-3.76|-0.76|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.76|-3.76|0.0031
71654790|NCT00430950|142827331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.0104||95.0|-3.61|-0.48|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)|||-0.48|-3.61|0.0104
71654791|NCT00430950|142827332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||||95.0|0.85|1.4|||Regression, Logistic|||||1.40|0.85|
71764981|NCT00353470|143032337|SUPERIORITY||shared parameters model|-0.56|STANDARD_ERROR_OF_MEAN|0.29|>|0.16|TWO_SIDED||||||Chi-squared|||Power: to detect a between-group effect size of 0.45, for statistical power of 0.80, 56 patients for PFPP or CBT vs. 28 for ART were required. Response rates at termination were calculated by chi-square in the full ITT sample using LOCF.||||>0.16
71764982|NCT00353470|143032337|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71764983|NCT02617485|143032351|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0406|||||TWO_SIDED|90.0|0.9565|1.1321||||||Estimated Geo LS-means ratio.||1.1321|0.9565|
71764984|NCT02617485|143032352|EQUIVALENCE|Equivalence met if the 90% CI of the Geo LS Means ratio is contained with the pre-specified equivalence margin of 70% - 143%.|Ratio of Geo LS-means|1.0611|||||TWO_SIDED|90.0|0.9822|1.1464||||||Estimated Geo LS-means ratio.||1.1464|0.9822|
71764985|NCT00505076|143032554|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.||||0.21
71764986|NCT00505076|143032555|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.47
71764987|NCT00505076|143032556|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2\[za+zβ\]2s2 (1-R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.||||0.84
71764988|NCT00322621|143032571|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.|Mean Difference (Net)|0.35|||<|0.001||97.5|0.35|0.79||Significance level 0.025|t-test, 1 sided|||Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.||0.79|0.35|<0.001
71764989|NCT00322621|143032574|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||t-test, 2 sided|||||||0.269
71764990|NCT00322621|143032575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71654792|NCT00703508|142827367|SUPERIORITY_OR_OTHER|||||||0.0234||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0234
71764991|NCT00322621|143032576|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.160
71654793|NCT00703508|142827367|SUPERIORITY_OR_OTHER|||||||0.074||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.0740
71654794|NCT00703508|142827367|SUPERIORITY_OR_OTHER|||||||0.4698||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p\<0.05|Regression, Linear|||||||0.4698
71654795|NCT00703508|142827367|SUPERIORITY_OR_OTHER|||||||0.118||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1180
71654796|NCT00703508|142827367|SUPERIORITY_OR_OTHER|||||||0.0311||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.0311
71654797|NCT00703508|142827367|SUPERIORITY_OR_OTHER|||||||0.1586||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p \< 0.05.|Regression, Linear|||||||0.1586
71654798|NCT01064323|142827369|OTHER|Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)||||||0.02|||||||Paired t-test|||||||0.02
71654799|NCT01064323|142827376|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.2
71826403|NCT02155829|143157389|SUPERIORITY|||||||0.684|||||||ANCOVA|ANCOVA covariate included site.||||||0.684
71654800|NCT01564459|142827391|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.587||||0.269|TWO_SIDED|95.0|-1.637|0.464|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.464|-1.637|0.269
71654801|NCT01564459|142827392|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.687||||0.108|TWO_SIDED|95.0|-1.527|0.154|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction||||0.154|-1.527|0.108
71654802|NCT03545191|142827438|OTHER||LS mean difference to placebo|-12.2|||<|0.0001|TWO_SIDED|95.0|-17.435|-6.961||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-6.961|-17.435|<0.0001
71826404|NCT02155829|143157390|SUPERIORITY|||||||0.913|||||||ANCOVA|ANCOVA covariate included site.||||||0.913
71764992|NCT00322621|143032577|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
71764993|NCT00322621|143032578|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||t-test, 2 sided|||||||0.075
71764994|NCT00322621|143032579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71764995|NCT00322621|143032580|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
71764996|NCT00322621|143032581|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
71826405|NCT02155829|143157391|SUPERIORITY|||||||0.746|||||||ANCOVA|ANCOVA covariate included site.||||||0.746
71826406|NCT02155829|143157392|SUPERIORITY|||||||0.057|||||||ANCOVA|ANCOVA covariate included site.||||||0.057
71826407|NCT02155829|143157393|SUPERIORITY|||||||0.0496|||||||ANCOVA|ANCOVA covariate included site.||||||0.0496
71707575|NCT00553475|142933075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09||||0.0002||95.0|-1.66|-0.52|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.66|0.0002
71707576|NCT00553475|142933076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67||||0.0008||95.0|-1.07|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.07|0.0008
71707577|NCT00553475|142933076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94||||0.0014||95.0|-1.51|-0.36|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.36|-1.51|0.0014
71707578|NCT00553475|142933077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.12|0.0003
71707579|NCT00553475|142933077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.0036||95.0|-1.44|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.44|0.0036
71707580|NCT00553475|142933078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0005||95.0|-1.1|-0.31|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.31|-1.10|0.0005
71707581|NCT00553475|142933078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87||||0.0034||95.0|-1.46|-0.29|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.29|-1.46|0.0034
71707582|NCT00553475|142933079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.0023||95.0|-1.02|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.22|-1.02|0.0023
71826408|NCT00678795|143157395|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.569|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.||0.26|-0.47|0.569
71707583|NCT00553475|142933079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0105||95.0|-1.36|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.36|0.0105
71826409|NCT00678795|143157396|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.76||||0.071|TWO_SIDED|95.0|-1.58|0.07|||ANCOVA|||The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.||0.07|-1.58|0.071
71707584|NCT00553475|142933080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.0016||95.0|-1.05|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-1.05|0.0016
71707585|NCT00553475|142933080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.0111||95.0|-1.37|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.37|0.0111
71707586|NCT00553475|142933081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07||||0.6118||95.0|-5.23|3.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.08|-5.23|0.6118
71707587|NCT00553475|142933081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.59||||0.0109||95.0|1.76|13.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.42|1.76|0.0109
71707588|NCT00553475|142933082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49||||0.4602||95.0|-2.47|5.45|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.45|-2.47|0.4602
71707589|NCT00553475|142933082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.97||||0.1625||95.0|-1.61|9.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.54|-1.61|0.1625
71707590|NCT00553475|142933083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.25|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.25|<0.0001
71707591|NCT00553475|142933083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.0273||95.0|-1.19|-0.07|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.07|-1.19|0.0273
71764997|NCT00322621|143032582|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|||||||0.406
71707592|NCT00553475|142933084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.79||||0.0013||95.0|-2.87|-0.71|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.71|-2.87|0.0013
71707593|NCT00553475|142933084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13||||0.0062||95.0|-3.65|-0.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.61|-3.65|0.0062
71707594|NCT00553475|142933085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0068||95.0|-1.03|-0.17|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.03|0.0068
71707595|NCT00553475|142933085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||0.0707||95.0|-1.17|0.05|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.05|-1.17|0.0707
71707596|NCT00553475|142933086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.35||||0.0013||95.0|-3.76|-0.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.93|-3.76|0.0013
71707597|NCT00553475|142933086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.67||||0.0087||95.0|-4.67|-0.68|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.68|-4.67|0.0087
71707598|NCT00553475|142933087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.27||||0.0056||95.0|-12.4|-2.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.14|-12.40|0.0056
71707599|NCT00553475|142933087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.49||||0.0427||95.0|-14.74|-0.25|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.25|-14.74|0.0427
71826410|NCT00678795|143157397|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.28||||0.01|TWO_SIDED|95.0|-0.5|-0.07|||ANCOVA|||The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.||-0.07|-0.50|0.010
71826411|NCT00678795|143157398|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.74|TWO_SIDED|95.0|-0.57|0.41|||ANCOVA|||The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.||0.41|-0.57|0.74
71707600|NCT00553475|142933088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.0365||95.0|-0.4|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-0.40|0.0365
71707601|NCT00553475|142933088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.0073||95.0|-0.65|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-0.65|0.0073
71707602|NCT00553475|142933089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.37||||0.0019||95.0|-10.38|-2.36|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.36|-10.38|0.0019
71707603|NCT00553475|142933089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.78||||0.1907||95.0|-9.45|1.89|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.89|-9.45|0.1907
71707604|NCT00553475|142933090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9905||95.0|-5.37|5.43|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.43|-5.37|0.9905
71707605|NCT00553475|142933090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.44||||0.2532||95.0|-3.19|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-3.19|0.2532
71707606|NCT00553475|142933091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.4538||95.0|-5.05|2.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.26|-5.05|0.4538
71707607|NCT00553475|142933091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84||||0.2782||95.0|-7.97|2.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.30|-7.97|0.2782
71707608|NCT00553475|142933092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32||||0.0177||95.0|0.06|0.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.59|0.06|0.0177
71707609|NCT00553475|142933092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.3661||95.0|-0.2|0.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.55|-0.20|0.3661
71707610|NCT00553475|142933093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62||||0.0511||95.0|-0.03|11.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.26|-0.03|0.0511
71707611|NCT00553475|142933093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.65||||0.0173||95.0|1.72|17.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.59|1.72|0.0173
71764998|NCT00322621|143032583|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|||||||0.021
71707612|NCT00553475|142933094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.79||||0.1123||95.0|-0.89|8.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.47|-0.89|0.1123
71707613|NCT00553475|142933094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.79||||0.0206||95.0|1.2|14.38|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||14.38|1.20|0.0206
71707614|NCT00553475|142933095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54||||0.0269||95.0|-6.67|-0.41|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.41|-6.67|0.0269
71654803|NCT03545191|142827438|OTHER||LS mean difference to placebo|-22.78|||<|0.0001|TWO_SIDED|95.0|-27.996|-17.567||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 50 mg vs placebo).||-17.567|-27.996|<0.0001
71654804|NCT03545191|142827439|OTHER||LS mean difference to placebo|-11.86|||<|0.0001|TWO_SIDED|95.0|-17.494|-6.23||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-6.23|-17.494|<0.0001
71654805|NCT03545191|142827439|OTHER||LS mean difference to placebo|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.945|-12.661||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 50 mg vs placebo).||-12.661|-23.945|<0.0001
71654806|NCT03545191|142827440|OTHER||LS mean difference to placebo|-8.32||||0.0005|TWO_SIDED|95.0|-13.014|-3.629||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-3.629|-13.014|0.0005
71654807|NCT03545191|142827440|OTHER||LS mean difference to placebo|-11.35|||<|0.0001|TWO_SIDED|95.0|-16.022|-6.687||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||-6.687|-16.022|<0.0001
71654808|NCT03545191|142827441|OTHER||LS mean difference to placebo|-7.59||||0.0015|TWO_SIDED|95.0|-12.265|-2.923||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.923|-12.265|0.0015
71654809|NCT03545191|142827441|OTHER||LS mean difference to placebo|-11.67|||<|0.0001|TWO_SIDED|95.0|-16.348|-6.994||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||-6.994|-16.348|<0.0001
71654810|NCT03545191|142827442|OTHER||LS mean difference to placebo|12.62|||=|0.0013|TWO_SIDED|95.0|4.953|20.288||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||20.288|4.953|= 0.0013
71654811|NCT03545191|142827442|OTHER||LS mean difference to placebo|22.06|||<|0.0001|TWO_SIDED|95.0|14.405|29.708||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||29.708|14.405|< 0.0001
71654812|NCT03545191|142827443|OTHER||LS mean difference to placebo|9.93|||=|0.0334|TWO_SIDED|95.0|0.782|19.082||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||19.082|0.782|= 0.0334
71654813|NCT03545191|142827443|OTHER||LS mean difference to placebo|19.77|||<|1e-05|TWO_SIDED|95.0|10.623|28.918||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 50 mg vs placebo).||28.918|10.623|< .00001
71654814|NCT03545191|142827444|OTHER||LS mean difference to placebo|-0.75|||=|0.0547|TWO_SIDED|95.0|-1.515|0.015||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.015|-1.515|= 0.0547
71707615|NCT00553475|142933095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.4183||95.0|-6.24|2.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.60|-6.24|0.4183
71707616|NCT00553475|142933096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0148
71707617|NCT00553475|142933096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0063
71764999|NCT00322621|143032584|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||t-test, 2 sided|||||||0.124
71765000|NCT00322621|143032585|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||t-test, 2 sided|||||||0.505
71765001|NCT00322621|143032586|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||t-test, 2 sided|||||||0.058
71765002|NCT00322621|143032587|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
71765003|NCT00322621|143032588|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
71765004|NCT00322621|143032589|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||||||0.022
71765005|NCT00322621|143032590|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.550
71765006|NCT00322621|143032591|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||t-test, 2 sided|||||||0.752
71765007|NCT00322621|143032592|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||t-test, 2 sided|||||||0.713
71765008|NCT00322621|143032593|SUPERIORITY_OR_OTHER|||||||0.066||95.0|||||t-test, 2 sided|||||||0.066
71765009|NCT00322621|143032594|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||t-test, 2 sided|||||||0.711
71765010|NCT00322621|143032595|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||t-test, 2 sided|||||||0.678
71765011|NCT00322621|143032596|SUPERIORITY_OR_OTHER|||||||0.216||95.0|||||t-test, 2 sided|||||||0.216
71765012|NCT00322621|143032597|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||t-test, 2 sided|||||||0.113
71765013|NCT00322621|143032600|SUPERIORITY_OR_OTHER|||||||0.368||95.0|||||t-test, 2 sided|||||||0.368
71765014|NCT00322621|143032601|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71765015|NCT00322621|143032602|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||t-test, 2 sided|||||||0.666
71765016|NCT00322621|143032603|SUPERIORITY_OR_OTHER|||||||0.138||95.0|||||t-test, 2 sided|||||||0.138
71765017|NCT00322621|143032604|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||t-test, 2 sided|||||||0.145
71765018|NCT00322621|143032605|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||t-test, 2 sided|||||||0.512
71765019|NCT01864005|143032625|SUPERIORITY_OR_OTHER|||||||0.0021||||||not adjusted for multiple comparisons. statistical significance level: 0.05|Wilcoxon (Mann-Whitney)|||||||0.0021
71765020|NCT01864005|143032625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.421||||0.0003|TWO_SIDED|95.0|18.559|58.283|||ANOVA|||||58.283|18.559|0.0003
71765021|NCT01864005|143032626|SUPERIORITY_OR_OTHER|||||||0.0828|||||||Wilcoxon (Mann-Whitney)|||||||0.0828
71765022|NCT01864005|143032627|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71765023|NCT01864005|143032628|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71765024|NCT01864005|143032629|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71765025|NCT00763698|143032630|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|95.0|5.0||||Kaplan-Meier Survival Analysis|||The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.|||5|
71765026|NCT00763698|143032631|SUPERIORITY_OR_OTHER||Objective Performance Criteria|80.0|||||ONE_SIDED|97.5|2.5||||Wilson score interval method||||||2.5|
71765027|NCT02059291|143032633|SUPERIORITY||||||<|0.0001|||||||Fisher's exact test|||||||<0.0001
71765028|NCT02059291|143032633|SUPERIORITY|||||||0.002|||||||Fisher's exact test|||||||0.0020
71765029|NCT02059291|143032633|SUPERIORITY|||||||0.005|||||||Fisher's exact test|||||||0.0050
71765030|NCT02059291|143032634|SUPERIORITY||Odds Ratio (OR)|16.96|||<|0.0001|TWO_SIDED|95.0|4.15|69.21|||Regression, Logistic|||||69.21|4.15|<0.0001
71765031|NCT02059291|143032634|SUPERIORITY||Odds Ratio (OR)|13.63||||0.0006|TWO_SIDED|95.0|2.83|65.59|||Regression, Logistic|||||65.59|2.83|0.0006
71765032|NCT02059291|143032634|SUPERIORITY||Odds Ratio (OR)|23.79||||0.0028|TWO_SIDED|95.0|2.52|224.86|||Regression, Logistic|||||224.86|2.52|0.0028
71765033|NCT02059291|143032635|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.0001|TWO_SIDED|95.0|5.86|151.31|||Regression, Logistic|||||151.31|5.86|<0.0001
71765034|NCT02059291|143032635|SUPERIORITY||Odds Ratio (OR)|12.71||||0.001|TWO_SIDED|95.0|2.53|63.89|||Regression, Logistic|||||63.89|2.53|0.0010
71765035|NCT02059291|143032635|SUPERIORITY||Odds Ratio (OR)|6.64||||0.0149|TWO_SIDED|95.0|1.2|36.57|||Regression, Logistic|||||36.57|1.20|0.0149
71765036|NCT02059291|143032636|SUPERIORITY||Odds Ratio (OR)|17.46||||0.0286|TWO_SIDED|95.0|0.92|332.92|||Regression, Logistic|||||332.92|0.92|0.0286
71765037|NCT02059291|143032636|SUPERIORITY||Odds Ratio (OR)|5.26||||0.0778|TWO_SIDED|95.0|0.53|51.97|||Regression, Logistic|||||51.97|0.53|0.0778
71765038|NCT02059291|143032636|SUPERIORITY||Odds Ratio (OR)|16.69||||0.0235|TWO_SIDED|95.0|1.04|268.5|||Regression, Logistic|||||268.50|1.04|0.0235
71765039|NCT02059291|143032637|SUPERIORITY||Odds Ratio (OR)|8.17||||0.0513|TWO_SIDED|95.0|0.75|113.44|||Regression, Logistic|||||113.44|0.75|0.0513
71765040|NCT02059291|143032637|SUPERIORITY||Odds Ratio (OR)|6.0||||0.2168|TWO_SIDED|95.0|0.27|366.24|||Regression, Logistic|||||366.24|0.27|0.2168
71765041|NCT02059291|143032637|SUPERIORITY||Odds Ratio (OR)|4.5||||0.3571|TWO_SIDED|95.0|0.15|313.49|||Regression, Logistic|||||313.49|0.15|0.3571
71765042|NCT01433289|143032639|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||The study hypothesis tested whether Polyphenon E given twice daily for 14 days at the specified doses has an effect on antiviral activity compared with placebo, measured by differences from baseline to day 14 in plasma HIV-1 RNA level (log10 copies/mL). The Wilcoxon signed-rank test was used to test the null hypothesis that there was no change at Day 14 versus baseline.||||>0.05
71765043|NCT01433289|143032639|SUPERIORITY|||||||0.74||||||Analysis was stratified by treatment group. The Kruskal-Wallis test was used to compare the change of log10 HIV-1 RNA copies/ml between treatment groups.|Kruskal-Wallis|||||||0.74
71765044|NCT03241368|143032643|OTHER|Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule \[referred to as capsule endoscopy (CE)\] as compared to IC with MRE.||||||0.125|||||||McNemar|Exact McNemar's test||This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.||||0.125
71765045|NCT01763996|143032656|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.756|TWO_SIDED|95.0|-10.1|13.76||0.05 level of significance|ANOVA|Analysis of variance (ANOVA) model that includes sequence, period, and treatment as fixed factors and subjects within sequence as a random factor.||||13.76|-10.10|0.756
71707618|NCT00553475|142933097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0818
71707619|NCT00553475|142933097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0075
71707620|NCT00553475|142933098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.0013||95.0|-1.07|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.07|0.0013
71707621|NCT00553475|142933098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.0152||95.0|-1.34|-0.14|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.34|0.0152
71707622|NCT02722330|142933124|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
71707623|NCT02722330|142933125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Ease of communication||||<0.0001
71707624|NCT02722330|142933125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Reverberation||||<0.0001
71707625|NCT02722330|142933125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Background noise||||<0.0001
71707626|NCT02722330|142933125|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wilcoxon Signed rank Test|||Aversiveness||||0.0004
71707627|NCT02722330|142933125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Global score||||<0.0001
71707628|NCT02722330|142933126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech scale||||<0.0001
71707629|NCT02722330|142933126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Spatial scale||||<0.0001
71707630|NCT02722330|142933126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Qualities scale||||<0.0001
71707631|NCT02722330|142933127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||||||<0.0001
71707632|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
71707633|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
71707634|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
71707635|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
71707636|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
71707637|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
71765046|NCT01616693|143032667|SUPERIORITY||Difference in seroconversion proportion|4.4|||||TWO_SIDED|97.5|-4.4|13.2||||||||13.2|-4.4|
71707638|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
71707639|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
71707640|NCT02722330|142933128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
71707641|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz||||<0.0001
71707642|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz||||<0.0001
71707643|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz||||<0.0001
71707644|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz||||<0.0001
71707645|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz||||<0.0001
71707646|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz||||<0.0001
71707647|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz||||<0.0001
71707648|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz||||<0.0001
71707649|NCT02722330|142933129|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz||||<0.0001
71707650|NCT02722330|142933130|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon Signed Rank test|||||||0.002
71707651|NCT02722330|142933131|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon Signed Rank test|||||||0.0024
71707652|NCT02722330|142933132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 50 dB||||<0.0001
71707653|NCT02722330|142933132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
71707654|NCT02722330|142933132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
71707655|NCT02722330|142933133|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All variable had the same p value (\<0.0001).|Wolcoxon Signed rank test|||Speech Presentation Level 50 dB||||<0.0001
71707656|NCT02722330|142933133|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB||||<0.0001
71707657|NCT02722330|142933133|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB||||<0.0001
71707658|NCT02722330|142933134|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon Signed Rank test|||||||0.036
71707659|NCT02722330|142933135|SUPERIORITY_OR_OTHER|||||||0.065|||||||Wilcoxon Signed Rank test|||||||0.065
71707660|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon Signed Rank test|||250 Hz||||0.47
71707661|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||500 Hz||||0.16
71707662|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon Signed Rank test|||750 Hz||||0.59
71707663|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.034|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.034
71765047|NCT01616693|143032667|SUPERIORITY||Difference in seroconversion proportion|7.5|||||TWO_SIDED|95.0|-1.4|16.2||||||||16.2|-1.4|
71765048|NCT01616693|143032667|SUPERIORITY||Difference in seroconversion proportion|12.0|||||TWO_SIDED|95.0|0.8|22.8||||||||22.8|.8|
71765049|NCT01616693|143032669|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-4.3|6.6||||||||6.6|-4.3|
71707664|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.25
71707665|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.023
71707666|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.028
71707667|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.0075
71707668|NCT02722330|142933136|SUPERIORITY_OR_OTHER|||||||0.0035|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.0035
71707669|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon Signed Rank test|||250 Hz||||0.12
71707670|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.072|||||||Wilcoxon Signed Rank test|||500 Hz||||0.072
71707671|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.56|||||||Wilcoxon Signed Rank test|||750 Hz||||0.56
71707672|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon Signed Rank test|||1000 Hz||||0.16
71707673|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon Signed Rank test|||1500 Hz||||0.39
71707674|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||2000 Hz||||0.11
71707675|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon Signed Rank test|||3000 Hz||||0.38
71707676|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.014|||||||Wilcoxon Signed Rank test|||4000 Hz||||0.014
71765050|NCT01616693|143032669|SUPERIORITY||Mean Difference (Net)|-3.1|||||TWO_SIDED|95.0|-8.6|2.3||||||||2.3|-8.6|
71707677|NCT02722330|142933137|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon Signed Rank test|||6000 Hz||||0.71
71707678|NCT02722330|142933138|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon Signed Rank test|||||||0.48
71707679|NCT02722330|142933139|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon Signed Rank test|||||||0.11
71707680|NCT02722330|142933140|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.017
71707681|NCT02722330|142933140|SUPERIORITY_OR_OTHER|||||||0.095|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||0.095
71707682|NCT02722330|142933140|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.57
71707683|NCT02722330|142933141|SUPERIORITY_OR_OTHER|||||||0.096|||||||Wilcoxon Signed Rank test|||SPL 50 dB||||0.096
71707684|NCT02722330|142933141|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon Signed Rank test|||SPL 65 dB||||1.00
71707685|NCT02722330|142933141|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon Signed Rank test|||SPL 80 dB||||0.41
71707686|NCT01934231|142933147|SUPERIORITY_OR_OTHER||Rate of Cure|88.5|||||TWO_SIDED|95.0|69.85|97.55|||||"The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of Cure/number of participants analyzed) \* 100."|||97.55|69.85|
71707687|NCT00382863|142933162|SUPERIORITY_OR_OTHER|||||||0.502|||||||Fisher Exact|One-sided||Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.||||0.502
71707688|NCT00382863|142933163|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.044
71707689|NCT00382863|142933164|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.||||0.184
71707690|NCT00382863|142933165|NON_INFERIORITY_OR_EQUIVALENCE|Estimated survival for the treatment group was 93%. Estimated survival for the control group was 91.5%. A non-inferiority margin of 7.5%. Final test alpha level of 0.04825.||||||0.012|||||||Exact binomial test|One-sided||The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.||||0.012
71707691|NCT00382863|142933166|SUPERIORITY_OR_OTHER|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||Class change from baseline.||||0.052
71707692|NCT00382863|142933167|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71707693|NCT00382863|142933168|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
71707694|NCT00382863|142933169|SUPERIORITY_OR_OTHER|||||||0.54|||||||Fisher Exact|One-sided||Improvement of at least 1.0 ml/kg/min from baseline.||||0.540
71707695|NCT00382863|142933170|SUPERIORITY_OR_OTHER|||||||0.067|||||||Fisher Exact|One-sided||Improvement of at least 45 m from baseline.||||0.067
71707696|NCT00382863|142933171|SUPERIORITY_OR_OTHER|||||||0.031|||||||Fisher Exact|One-sided||Improvement of at least 7 points from baseline.||||0.031
71707697|NCT00382863|142933172|SUPERIORITY_OR_OTHER|||||||0.109|||||||Log Rank|||Kaplan-Meier actuarial time-to-first-event analysis||||0.109
71707698|NCT00382863|142933173|SUPERIORITY_OR_OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.031
71707699|NCT00382863|142933174|SUPERIORITY_OR_OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.179
71707700|NCT00382863|142933175|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.070
71707701|NCT00382863|142933176|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.015
71707702|NCT00382863|142933177|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.032
71707703|NCT00382863|142933179|SUPERIORITY_OR_OTHER|||||||0.627|||||||Fisher Exact|Two-sided||||||0.627
71707704|NCT00382863|142933180|SUPERIORITY_OR_OTHER|||||||0.386|||||||Log Rank|||||||0.386
71707705|NCT00382863|142933181|SUPERIORITY_OR_OTHER|||||||0.154|||||||Fisher Exact|Two-sided||||||0.154
71707706|NCT00382863|142933182|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-sided||||||1.000
71707707|NCT00382863|142933183|SUPERIORITY_OR_OTHER|||||||0.939|||||||Log Rank|||||||0.939
71765051|NCT01616693|143032669|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-9.8|5.7||||||||5.7|-9.8|
71765052|NCT00743106|143032681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.15|TWO_SIDED|95.0|-31.0|9.0|||Wilcoxon (Mann-Whitney)||The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).|||9|-31|0.15
71707708|NCT00382863|142933184|SUPERIORITY_OR_OTHER|||||||0.012|||||||Fisher Exact|Two-sided||||||0.012
71707709|NCT00382863|142933185|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
71707710|NCT00382863|142933186|SUPERIORITY_OR_OTHER|||||||0.772|||||||Wilcoxon (Mann-Whitney)|Two-sided||||||0.772
71707711|NCT02837952|142933206|SUPERIORITY||Least Square Mean Difference|72.89|||<|0.001|TWO_SIDED|95.0|50.075|95.707|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||95.707|50.075|<0.001
71707712|NCT02837952|142933207|SUPERIORITY||Least Square Mean Difference|26.45|||<|0.001|TWO_SIDED|95.0|19.895|33.005|||ANCOVA|||0 to 8 hours: Treatment difference and 95% CI were based on least square (LS) mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||33.005|19.895|< 0.001
71707713|NCT02837952|142933207|SUPERIORITY||LS Mean Difference|7.91|||<|0.001|TWO_SIDED|95.0|5.196|10.632|||ANCOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.632|5.196|< 0.001
71707714|NCT02837952|142933207|SUPERIORITY||LS Mean Difference|51.67|||<|0.001|TWO_SIDED|95.0|37.075|66.258|||ANCOVA|||0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||66.258|37.075|< 0.001
71707715|NCT02837952|142933207|SUPERIORITY||LS Mean Difference|27.32|||<|0.001|TWO_SIDED|95.0|18.139|36.508|||ANCOVA|||8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||36.508|18.139|< 0.001
71707716|NCT02837952|142933207|SUPERIORITY||LS Mean Difference|138.65|||<|0.001|TWO_SIDED|95.0|91.045|186.261|||ANCOVA|||0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||186.261|91.045|< 0.001
71707717|NCT02837952|142933208|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
71707718|NCT02837952|142933209|SUPERIORITY||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test|||||||<0.001
71707719|NCT01362530|142933210|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
71707720|NCT01362530|142933211|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.05
71707721|NCT01362530|142933212|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
71707722|NCT01362530|142933213|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.||||||<0.01
71707723|NCT04250363|142933241|OTHER||Odds Ratio (OR)|3.57||||0.00284|TWO_SIDED|95.0|1.85|10.6|||Regression, Logistic|||||10.6|1.85|0.00284
71707724|NCT04250363|142933241|OTHER||Odds Ratio (OR)|4.19||||0.00367|TWO_SIDED|95.0|2.0|14.8|||Regression, Logistic|||||14.8|2.00|0.00367
71707725|NCT04250363|142933241|OTHER||Odds Ratio (OR)|4.22||||0.0137|TWO_SIDED|95.0|1.9|23.7|||Regression, Logistic|||||23.7|1.90|0.0137
71707726|NCT04250363|142933241|OTHER||Odds Ratio (OR)|2.23||||0.00349|TWO_SIDED|95.0|1.47|4.48|||Regression, Logistic|||||4.48|1.47|0.00349
71707727|NCT04250363|142933241|OTHER||Odds Ratio (OR)|11.6||||0.00594|TWO_SIDED|95.0|3.19|129.0|||Regression, Logistic|||||129|3.19|0.00594
71707728|NCT02197065|142933243|OTHER||Proportion|0.2|||||ONE_SIDED|||||||||This was a pilot feasibility study and we were only powered to determine the frequency of troponin elevation in the entire study population, not to compare the frequency of a rise in troponin in the two study arms. Thus Aim 1 applies to the entire study cohort.||||
71707729|NCT02197065|142933244|SUPERIORITY||Median Difference (Final Values)|13.0||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
71707730|NCT02197065|142933245|SUPERIORITY||Median Difference (Final Values)|0.3||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71707731|NCT00276380|142933246|OTHER||Odds Ratio (OR)|0.83||||0.52|TWO_SIDED|95.0|0.46|1.48|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.48|0.46|0.52
71707732|NCT00276380|142933247|OTHER|Comparison of treatment effect at Day 28|Odds Ratio (OR)|0.86||||0.623|TWO_SIDED|95.0|0.47|1.57|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.57|0.47|0.623
71707733|NCT00276380|142933247|OTHER|Comparison of treatment effect at Day 84|Odds Ratio (OR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.3|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.||1.3|0.42|0.3
71707734|NCT00276380|142933249|OTHER|||||||0.207||||||Treatment effect was derived using a parametric analysis of covariance (ANCOVA) with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.207
71707735|NCT00276380|142933249|OTHER|||||||0.59||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.590
71707736|NCT00276380|142933249|OTHER|Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.||||||0.814|||||||ANCOVA|||Comparison of treatment effect at Day 168||||0.814
71707737|NCT00276380|142933250|OTHER|||||||0.24||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.240
71654815|NCT03545191|142827444|OTHER||LS mean difference to placebo|-1.75|||<|1e-05|TWO_SIDED|95.0|-2.508|-0.983||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 50 mg vs placebo).||-0.983|-2.508|< .00001
71654816|NCT03545191|142827445|OTHER||LS mean difference to placebo|-0.99||||0.0534|TWO_SIDED|95.0|-1.99|0.014||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||0.014|-1.990|0.0534
71654817|NCT03545191|142827445|OTHER||LS mean difference to placebo|-1.9|||=|0.0002|TWO_SIDED|95.0|-2.905|-0.905|||Mixed Models Analysis|||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 50 mg vs placebo).||-0.905|-2.905|= 0.0002
71654818|NCT03545191|142827446|OTHER||LSGM ratio to placebo|0.79||||0.0003|TWO_SIDED|95.0|0.7|0.9||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.90|0.70|0.0003
71654819|NCT03545191|142827446|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.65|0.82||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 50 mg vs placebo).||0.82|0.65|<0.0001
71654820|NCT03545191|142827447|OTHER||LSGM ratio to placebo|0.78||||0.0002|TWO_SIDED|95.0|0.68|0.89||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.89|0.68|0.0002
71654821|NCT03545191|142827447|OTHER||LSGM ratio to placebo|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.83||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 50 mg vs placebo).||0.83|0.64|<0.0001
71654822|NCT01769274|142827461|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
71654823|NCT01769274|142827461|OTHER|||||||1|||||||Hierarchical rank test|||||||1.0000
71654824|NCT02377063|142827471|OTHER||Mean Difference (Final Values)|-11.2||||0.014|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumption||||0.014
71654825|NCT02377063|142827471|OTHER||Mean Difference (Final Values)|10.5||||0.026|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumption||||0.026
71707738|NCT00276380|142933250|OTHER|||||||0.441||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.441
71654826|NCT02340221|142827492|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0037|TWO_SIDED|95.0|0.56|0.89|||Log Rank|||||0.89|0.56|0.0037
71654827|NCT02340221|142827493|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0008|TWO_SIDED|95.0|0.58|0.87|||Log Rank|||||0.87|0.58|0.0008
71654828|NCT02340221|142827494|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0002|TWO_SIDED|95.0|1.6|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.6|0.0002
71654829|NCT02340221|142827495|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.7|5.4|||Cochran-Mantel-Haenszel|||||5.4|1.7|<0.0001
71707739|NCT00276380|142933250|OTHER|||||||0.645||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 168||||0.645
71654830|NCT02340221|142827496|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4151|TWO_SIDED|95.0|0.58|1.25|||Log Rank|||||1.25|0.58|0.4151
71654831|NCT02340221|142827497|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9974|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||||1.33|0.75|0.9974
71654832|NCT02340221|142827498|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|2.9||||||||2.9|1.2|
71654833|NCT02340221|142827499|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.2|3.0||||||||3.0|1.2|
71654834|NCT02340221|142827500|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.6708|TWO_SIDED|95.0|0.23|2.59|||Log Rank|||||2.59|0.23|0.6708
71654835|NCT02340221|142827501|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8286|TWO_SIDED|95.0|0.51|2.35|||Log Rank|||||2.35|0.51|0.8286
71654836|NCT02340221|142827502|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0023|TWO_SIDED|95.0|0.51|0.86|||Log Rank|||||0.86|0.51|0.0023
71654837|NCT02340221|142827503|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0095|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.0095
71654838|NCT01172821|142827521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.159|0.264|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.264|0.159|<0.0001
71707740|NCT00276380|142933251|OTHER|||||||0.623||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28||||0.623
71707741|NCT00276380|142933251|OTHER|||||||0.338||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84||||0.338
71707742|NCT00276380|142933251|OTHER|||||||0.828||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates|ANCOVA|||Comparison of treatment effect at Day 168||||0.828
71886587|NCT01340209|143293511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.048||0.7971|TWO_SIDED|95.0|-0.082|0.106|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.106|-0.082|0.7971
71707743|NCT04829214|142933255|SUPERIORITY||Risk Difference (RD)|-10.2|STANDARD_ERROR_OF_MEAN|7.9|=|0.385|TWO_SIDED|95.0|-26.0|5.0|||Mantel Haenszel|||The percentage of responders will be compared between the two groups using the Mantel Haenszel test controlling for category of duration of tinnitus and category of baseline TFI overall score. The primary efficacy analysis will be conducted for the comparison of OTO-313 and placebo, using a 2-sided test and an alpha level of 5%. The 95% confidence intervals (CI) around the common risk difference will also be provided.||5|-26|=0.385
71707744|NCT02571244|142933274|SUPERIORITY||Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.99|1.85||||||||1.85|0.99|
71707745|NCT02571244|142933275|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71707746|NCT02571244|142933276|SUPERIORITY|||||||0.42|||||||Fisher Exact|||||||0.42
71707747|NCT02571244|142933277|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.08|1.95||||||||1.95|1.08|
71707748|NCT02571244|142933278|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|1.07|1.92||||||||1.92|1.07|
71707749|NCT00452530|142933300|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.0003||||||1-sided P-value|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||||0.0003
71707750|NCT00452530|142933300|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.04||||||95.0|-2.03|-0.05|||Inverse variance method|||Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.||-0.05|-2.03|
71707751|NCT00452530|142933301|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.33||||0.3014|TWO_SIDED|95.0|-0.95|0.29|||Mantel Haenszel||Apixaban-enoxaparin|Major bleeding||0.29|-0.95|0.3014
71707752|NCT00452530|142933301|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-0.91||||0.1668|TWO_SIDED|95.0|-2.2|0.38|||Mantel Haenszel||Apixaban-enoxaparin|CRNM||0.38|-2.20|0.1668
71707753|NCT00452530|142933301|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.24||||0.0881|TWO_SIDED|95.0|-2.66|0.18|||Mantel Haenszel||Apixaban-enoxaparin|Major or CRNM||0.18|-2.66|0.0881
71707754|NCT00452530|142933301|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|-1.39||||0.1412|TWO_SIDED|95.0|-3.29|0.51|||Mantel Haenszel||Apixaban-enoxaparin|Any bleeding||0.51|-3.29|0.1412
71707755|NCT00452530|142933302|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.74||P-value was statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||0.74|0.51|<0.0001
71707756|NCT00452530|142933302|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.27|||<|0.0001||95.0|-12.74|-5.79||P-value is statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.||-5.79|-12.74|<0.0001
71707757|NCT03888482|142933309|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.01|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Clariti|||0.01||
71707758|NCT03907579|142933310|SUPERIORITY|||||||0.0001|||||||Wilcoxon Signed Rank Test|z= -3.861||||||0.0001
71707759|NCT03319654|142933317|OTHER|A generalized estimating equation (GEE)-model with an exchangeable correlation structure and a logit link function was used to analyze the probability of live birth and clinical pregnancy respectively. All IUI cycles are used in this model with correction for the fact that cycles of the same couple are not independent.|Odds Ratio (OR)|0.94||||0.04|TWO_SIDED|95.0|0.9|0.9985|||GEE-model|||The null hypothesis is: there is no association between % total Sperm DNA Fragmentation and live birth.||0.9985|0.90|0.04
71707760|NCT03319654|142933317|OTHER||Area under the ROC curve|0.576|||>|0.05|TWO_SIDED||||||Receiver Operating Characteristics curve|||||||>0.05
71707761|NCT01725308|142933324|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.4||||0.034|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|||An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.||-0.2|-4.7|0.034
71707762|NCT01725308|142933331|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.7||||0.033|TWO_SIDED|95.0|-3.3|-0.1|||ANCOVA|||At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.||-0.1|-3.3|0.033
71707763|NCT04128228|142933369|OTHER|"Single group: All individuals with alcohol use disorder received the same treatment.~Brain responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT)."|F value for the 2 X 2 Group Interaction|5.5|||<|0.05|TWO_SIDED|||||A 2 × 2 × 3 Linear Mixed Model was conducted with Early Trauma Group (ET, NT) and Drinking Group (AUD, MD) as between-subjects factors, and Condition (stress, alcohol, neutral) as the within-subjects factor.|Linear Mixed Model|||A regions of interest (ROI) analysis was conducted to evaluate brain activity in the right ventromedial prefrontal cortex (VmPFC, BA10), a region identified a priori. The VmPFC ROI was defined using the Yale-Brodmann atlas in the BioImage Suite application, from which the beta value for the VmPFC ROI was obtained for a Linear Mixed Model analysis.||||<0.05
71707764|NCT04128228|142933370|OTHER|Single group (all individuals with alcohol use disorder received the same treatment). Hormone responses were examined at baseline in individuals with alcohol use disorder (AUD) with and without early trauma (AUD/ET, AUD/NT), as well as in moderate drinkers (MD) with and without early trauma (MD/ET, MD/NT).|F value|4.79|||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
71707765|NCT04128228|142933371|OTHER|Single Group|Hazard Ratio (HR)|0.71|||<|0.05|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||||.95|.53|<0.05
71707766|NCT04128228|142933372|OTHER|Single Group. All individuals with alcohol use disorder received the same treatment.|t value|-3.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71707767|NCT04128228|142933373|OTHER|Single Group (All individuals with alcohol use disorder received the same treatment.)|t value|-2.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71707768|NCT03163264|142933374|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|95.0|0.0|3.45||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.050"|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.45|0|0.050
71707769|NCT03163264|142933374|SUPERIORITY||Mean Difference (Net)|0.05||||0.05|TWO_SIDED|||||"Statistical test was 2 sided with p\<0.05 indicating statistical significance. Note: Estimated p-value was calculated at 0.05"|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||||0.05
71707770|NCT03163264|142933375|SUPERIORITY||Mean Difference (Net)|0.069||||0.069|TWO_SIDED|95.0|-0.13|3.39||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|This analysis was in our grant and protocol paper but was added late to clinicaltrials.gov.||||3.39|-0.13|0.069
71707771|NCT03163264|142933375|SUPERIORITY||Mean Difference (Final Values)|1.53||||0.028|TWO_SIDED|95.0|0.21|3.76||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Wilcoxon (Mann-Whitney)|The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics||||3.76|0.21|0.028
71707772|NCT03163264|142933376|SUPERIORITY||Percent Difference|11.18||||0.033|TWO_SIDED|95.0|0.92|21.45|||Mixed Models Analysis|||||21.45|0.92|0.033
71707773|NCT03163264|142933377|SUPERIORITY||Percent Difference|11.08||||0.073|TWO_SIDED|95.0|-1.05|23.2||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis||Adjusted|||23.2|-1.05|0.073
71707774|NCT03163264|142933379|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.065|TWO_SIDED|95.0|-0.05|1.48||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.48|-0.05|0.065
71707775|NCT03163264|142933380|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.378|TWO_SIDED|95.0|-0.52|1.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||1.37|-0.52|0.378
71707776|NCT03163264|142933382|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.911|TWO_SIDED|95.0|-138.25|154.95||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||154.95|-138.25|0.911
71707777|NCT03163264|142933383|SUPERIORITY||Mean Difference (Final Values)|32.83||||0.648|TWO_SIDED|95.0|-108.15|173.81||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||173.81|-108.15|0.648
71707778|NCT03163264|142933384|SUPERIORITY||Percent Difference|10.32||||0.736|TWO_SIDED|95.0|-49.73|70.37||Statistical test was 2 sided with p\<0.05 indicating statistical significance|Mixed Models Analysis|||||70.37|-49.73|0.736
71707779|NCT03163264|142933385|SUPERIORITY||Percent Difference|19.36||||0.53|TWO_SIDED|95.0|-41.09|79.8||Statistical test was 2 sided with p\<0.05 indicating statistical significance.|Mixed Models Analysis|||||79.8|-41.09|0.53
71707780|NCT03000166|142933386|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
71707781|NCT03000166|142933387|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.40
71707782|NCT03000166|142933388|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71707783|NCT03000166|142933389|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71826412|NCT00678795|143157399|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.9||||0.166|TWO_SIDED|95.0|-1.65|9.46|||ANCOVA|||The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.||9.46|-1.65|0.166
71707784|NCT04565756|142933424|OTHER|||||||||||||||||Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables. All statistical analyses were descriptive in nature and any statistical inferences were carried out according to the analysis plan and interpreted in view of the exploratory nature of the study.|Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables.|||
71707785|NCT05226884|142933446|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71707786|NCT05226884|142933447|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71707787|NCT05226884|142933448|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71707788|NCT05226884|142933449|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||||||||||||||The defocus curve is generated based on measurements over a dioptric range.|||
71707789|NCT05226884|142933450|NON_INFERIORITY|Non-inferiority defined as within 0.1 LogMAR (1 line on Snellen Chart).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.||||||<0.05
71707790|NCT00066937|142933494|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline to each timepoint||||||<.05
71707791|NCT00066937|142933495|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
71707792|NCT00066937|142933496|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
71707793|NCT00066937|142933497|OTHER||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)||||||<.05
71707794|NCT03072875|142933498|OTHER|Descriptive statistic.|||||||||||||||||Quantitative data (descriptive statistic) from the USAQ were used to determine feasibility. Specifically, we established an a priori mean score of 3.5 or greater on the USAQ to determine feasibility.|||
71707795|NCT03478787|142933500|NON_INFERIORITY|Non-inferiority is met if the lower bound of the 96.25% confidence interval (CI) of adjusted treatment difference is above -12%.|Adjusted percentage difference|8.2|||||TWO_SIDED|96.25|-2.2|18.6|||||Across the strata, 96.25% confidence interval (CI) for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||18.6|-2.2|
71707796|NCT03478787|142933501|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.8|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.8|< 0.001
71707797|NCT03478787|142933502|SUPERIORITY||Adjusted percentage difference|26.2|||<|0.001|TWO_SIDED|95.0|15.9|36.5||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||36.5|15.9|< 0.001
71707798|NCT03478787|142933503|SUPERIORITY||Adjusted percentage difference|29.8|||<|0.001|TWO_SIDED|95.0|20.9|38.8||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||38.8|20.9|< 0.001
71707799|NCT03478787|142933504|SUPERIORITY||Adjusted percentage difference|20.0|||<|0.001|TWO_SIDED|95.0|11.7|28.3||Across the strata, p-value was calculated from the from the Cochran-Mantel-Haenszel test adjusted for strata.|Cochran-Mantel-Haenszel||Across the strata, 95% CI for adjusted difference was calculated according to the Cochran-Mantel-Haenszel test for the comparison of 2 treatment groups.|||28.3|11.7|< 0.001
71707800|NCT04679818|142933505|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.895|TWO_SIDED|99.0|-1.43|1.58|||Mixed Models Analysis|||||1.58|-1.43|0.895
71707801|NCT04679818|142933506|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.228|TWO_SIDED|99.0|-2.66|0.99|||Mixed Models Analysis|||||0.99|-2.66|0.228
71707802|NCT04679818|142933507|SUPERIORITY||Risk Ratio (RR)|0.81||||0.565|TWO_SIDED|95.0|0.4|1.65|||generalized linear mixed effects model|||||1.65|0.40|0.565
71707803|NCT04679818|142933508|SUPERIORITY||Risk Ratio (RR)|1.48||||0.379|TWO_SIDED|95.0|0.62|3.54|||Generalized linear mixed effects model|||||3.54|0.62|0.379
71707804|NCT04679818|142933509|SUPERIORITY||Median Difference (Final Values)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Wilcoxon (Mann-Whitney)|||||0.97|0.30|0.039
71707805|NCT04679818|142933510|NON_INFERIORITY|We tested noninferiority of NOL to routine care on the Ramsey score using an a priori-defined noninferiority delta of 1.2 for the proportional odds ratio; NOL would be deemed noninferior if the upper confidence limit for the odds ratio was \<1.2.|Odds Ratio (OR)|0.8||||0.169|TWO_SIDED|95.0|0.35|1.82|||proportional odds model|||||1.82|0.35|0.169
71707806|NCT04679818|142933511|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.967|TWO_SIDED|95.0|0.63|1.63|||Cox proportional hazards regression|||||1.63|0.63|0.967
71707807|NCT01316900|142933518|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.142|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.142|0.039|<0.001
71707808|NCT01316900|142933518|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.141||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Tio 18 µg.|||0.141|0.039|<0.001
71707809|NCT01316900|142933518|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.140|0.036|<0.001
71707810|NCT01316900|142933518|SUPERIORITY_OR_OTHER||Least squares mean difference|0.088|||<|0.001|TWO_SIDED|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.140|0.036|<0.001
71707811|NCT00507507|142933564|SUPERIORITY_OR_OTHER|||||||0.016||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||The null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference. The sample size provided at least 85% power to detect a difference of 30% between the groups, assuming response rates of 30% and 60% in the Tenofovir DF and FTC+Tenofovir DF groups, respectively.||||0.016
71707812|NCT00507507|142933565|SUPERIORITY_OR_OTHER|||||||0.05||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.050
71707813|NCT00507507|142933565|SUPERIORITY_OR_OTHER|||||||0.009||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.009
71707814|NCT00507507|142933565|SUPERIORITY_OR_OTHER|||||||0.03||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 400 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.030
71707815|NCT00507507|142933566|SUPERIORITY_OR_OTHER|||||||0.703||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.703
71707816|NCT00507507|142933566|SUPERIORITY_OR_OTHER|||||||0.034||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.034
71707817|NCT00507507|142933566|SUPERIORITY_OR_OTHER|||||||0.011||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.011
71707818|NCT00507507|142933566|SUPERIORITY_OR_OTHER|||||||0.007||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA \< 169 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.007
71707819|NCT00507507|142933567|SUPERIORITY_OR_OTHER|||||||0.01||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.010
71707820|NCT00507507|142933568|SUPERIORITY_OR_OTHER|||||||0.019||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.019
71707821|NCT00507507|142933569|SUPERIORITY_OR_OTHER|||||||0.186||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.186
71707822|NCT00507507|142933570|SUPERIORITY_OR_OTHER|||||||0.07||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.070
71707823|NCT00507507|142933571|SUPERIORITY_OR_OTHER|||||||0.467||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.467
71707824|NCT00507507|142933571|SUPERIORITY_OR_OTHER|||||||1||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||1.000
71707825|NCT00507507|142933571|SUPERIORITY_OR_OTHER|||||||0.529||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.529
71707826|NCT00507507|142933571|SUPERIORITY_OR_OTHER|||||||0.451||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.451
71707827|NCT00507507|142933572|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
71707828|NCT00507507|142933572|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
71707829|NCT00507507|142933572|SUPERIORITY_OR_OTHER|||||||0.365||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.365
71707830|NCT00507507|142933573|SUPERIORITY_OR_OTHER|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.496
71707831|NCT00507507|142933573|SUPERIORITY_OR_OTHER|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.119
71707832|NCT00507507|142933573|SUPERIORITY_OR_OTHER|||||||0.244||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.||||0.244
71654839|NCT01172821|142827521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.116|0.222|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.222|0.116|<0.0001
71654840|NCT01172821|142827522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.12|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.120|<0.0001
71654841|NCT01172821|142827522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.076|0.19|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.190|0.076|<0.0001
71654842|NCT01172821|142827523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|0.052|0.168|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.168|0.052|0.0002
71654843|NCT01172821|142827523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.03||0.0031|TWO_SIDED|95.0|0.03|0.147|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.147|0.030|0.0031
71654844|NCT01172821|142827524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.032||0.0061|TWO_SIDED|95.0|0.025|0.149|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.149|0.025|0.0061
71654845|NCT01172821|142827524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.032||0.0093|TWO_SIDED|95.0|0.021|0.146|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.146|0.021|0.0093
71654846|NCT01172821|142827525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.252|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.252|0.150|<0.0001
71654847|NCT01172821|142827525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.112|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.112|<0.0001
71738984|NCT00620113|142990732|SUPERIORITY_OR_OTHER||Difference in LS Means|4.66|||<|0.001|TWO_SIDED|95.0|3.18|6.14||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||6.14|3.18|<0.001
71654848|NCT01172821|142827526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.029||0.0002|TWO_SIDED|95.0|0.052|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.052|0.0002
71654849|NCT01172821|142827526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.029||0.0019|TWO_SIDED|95.0|0.033|0.145|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.145|0.033|0.0019
71654850|NCT01172821|142827527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.759|STANDARD_ERROR_OF_MEAN|4.963|<|0.0001|TWO_SIDED|95.0|19.025|38.494|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||38.494|19.025|<0.0001
71707833|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993||95% confidence interval is used instead of p-value.|Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
71707834|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||Deming Regression|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.17|-0.25|
71707835|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||TWO_SIDED|95.0|0.987|0.993|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.993|0.987|
71707836|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.03|||||TWO_SIDED|95.0|-0.24|0.18|||Regression, Linear|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||0.18|-0.24|
71707837|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.995|||||TWO_SIDED|95.0|0.99|1.0|||Passing-Bablock|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|||1.000|0.990|
71707838|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|Intercept|-0.04|||||TWO_SIDED|95.0|-0.3|0.01|||Passing-Bablok|Analyses to determine the comparability between UHR \& DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|95% confidence interval is used instead of p-value.|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.||0.01|-0.30|
71707839|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|Described previously|Relative Sensitivity, %|100.0|||||TWO_SIDED|95.0|85.8|100.0|||||95% confidence interval is used instead of p-value.|Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.||100|85.8|
71707840|NCT01623154|142933581|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously|Relative Specificity, %|100.0|||||TWO_SIDED|95.0|94.9|100.0|||||95% confidence interval is used instead of p-value.|||100|94.9|
71707841|NCT00954538|142933588|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71707842|NCT00954538|142933589|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|||||TWO_SIDED|90.0|-0.04|0.27|||Linear Fixed Effects Model||Difference = AD group value - HE group value|A 90% confidence interval was calculated for the group difference (AD - HE) using the model results. As prespecified by the analysis plan, if the lower bound of the 90% confidence interval is above 0, then the hypothesis that \[18F\]MK-3328 can discriminate between AD patients and cognitively normal elderly controls as measured by regional tracer uptake following single IV doses of \[18F\]MK-3328 is supported.||0.27|-0.04|
71707843|NCT00600704|142933607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.379|STANDARD_DEVIATION|0.096|<|0.05|TWO_SIDED|95.0|0.189|0.569|||t-test, 2 sided|||Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.||0.569|0.189|<0.05
71707844|NCT00600704|142933607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.797|STANDARD_ERROR_OF_MEAN|0.168|<|0.05|TWO_SIDED|95.0|0.465|1.129|||Regression, Linear||The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.|Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.||1.129|0.465|<0.05
71707845|NCT00215553|142933653|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.794
71707846|NCT00215553|142933653|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.236
71707847|NCT00215553|142933653|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups||||0.396
71707848|NCT00215553|142933654|SUPERIORITY_OR_OTHER|||||||0.346||95.0|||||Cochran-Mantel-Haenszel|||||||0.346
71707849|NCT00215553|142933654|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Cochran-Mantel-Haenszel|||||||0.286
71707850|NCT00215553|142933654|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Cochran-Mantel-Haenszel|||||||0.964
71707851|NCT00215553|142933655|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|ANOVA on ranks||||||0.028
71707852|NCT00215553|142933655|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANOVA|ANOVA on ranks||||||0.147
71707853|NCT00215553|142933655|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANOVA|ANOVA on ranks||||||0.293
71707854|NCT00159874|142933706|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-7.02|STANDARD_ERROR_OF_MEAN|6.1||0.253|TWO_SIDED|95.0|-19.13|5.09|||ANCOVA||Least square mean difference of -7.02 was calculated as ' Sildenafil Medium Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||5.09|-19.13|0.253
71707855|NCT00159874|142933706|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-9.84|STANDARD_ERROR_OF_MEAN|5.92||0.1|TWO_SIDED|95.0|-21.6|1.93|||ANCOVA||Least square mean difference of -9.84 was calculated as ' Sildenafil High Dose - Low Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||1.93|-21.60|0.100
71707856|NCT00159874|142933706|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-2.82|STANDARD_ERROR_OF_MEAN|6.01||0.64|TWO_SIDED|95.0|-14.75|9.11|||ANCOVA||Least square mean difference of -2.82 was calculated as ' Sildenafil High Dose - Medium Dose'|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.||9.11|-14.75|0.640
71707857|NCT04019704|142933731|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71707858|NCT02662582|142933761|SUPERIORITY||LSMean difference|-12.0||||0.734|TWO_SIDED|90.0|-71.2|47.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Least square means (LSMeans), LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||47.2|-71.2|0.734
71707859|NCT02662582|142933762|SUPERIORITY||LSMean Difference|-0.0219||||0.438|TWO_SIDED|90.0|-0.0694|0.0256||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0256|-0.0694|0.438
71707860|NCT02662582|142933762|SUPERIORITY||LSMean Difference|-0.0325||||0.114|TWO_SIDED|90.0|-0.0663|0.0014||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0014|-0.0663|0.114
71707861|NCT02662582|142933763|SUPERIORITY||LSMean difference|0.75||||0.612|TWO_SIDED|90.0|-1.75|3.24||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.24|-1.75|0.612
71707862|NCT02662582|142933763|SUPERIORITY||LSMean difference|0.29||||0.789|TWO_SIDED|90.0|-1.55|2.14||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||2.14|-1.55|0.789
71707863|NCT02662582|142933764|SUPERIORITY||LSMean difference|0.72||||0.225|TWO_SIDED|90.0|-0.26|1.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.70|-0.26|0.225
71707864|NCT02662582|142933764|SUPERIORITY||LSMean difference|0.92||||0.064||90.0|0.11|1.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.174|0.11|0.064
71707865|NCT02662582|142933765|SUPERIORITY||LSMean difference|0.052||||0.447|TWO_SIDED|90.0|-0.063|0.167||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.167|-0.063|0.447
71707866|NCT02662582|142933766|SUPERIORITY||LSMean difference|-0.8||||0.099|TWO_SIDED|90.0|-1.7|0.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0|-1.7|0.099
71765053|NCT00743106|143032682|SUPERIORITY||ratio of geometric mean|0.98||||0.78|TWO_SIDED|95.0|0.79|1.19|||Mixed Models Analysis|||We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.||1.19|0.79|0.78
71765054|NCT00993226|143032683|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_DEVIATION|0.29||0.467|TWO_SIDED|95.0|-0.79|0.36|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.36|-0.79|0.467
71765055|NCT00993226|143032684|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_DEVIATION|2.57||0.331|TWO_SIDED|95.0|-7.59|2.58|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||2.58|-7.59|0.331
71826413|NCT00678795|143157400|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.16||||0.001|TWO_SIDED|95.0|-1.82|-0.51|||ANCOVA|||The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.||-0.51|-1.82|0.001
71826414|NCT00678795|143157401|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|25.4||||0.002|TWO_SIDED|95.0|10.37|40.42|||Fisher Exact|||For Patient Global Impression of Change, the proportions of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' were compared between treatment groups using Fisher's Exact Test.||40.42|10.37|0.002
71654851|NCT01172821|142827527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.178|STANDARD_ERROR_OF_MEAN|4.985|<|0.0001|TWO_SIDED|95.0|18.401|37.956|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||37.956|18.401|<0.0001
71654852|NCT01172821|142827528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.068||0.87|TWO_SIDED|95.0|-0.122|0.144|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.144|-0.122|0.8700
71654853|NCT01172821|142827528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.068||0.9612|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.130|-0.137|0.9612
71654854|NCT01172821|142827529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.059||0.0305|TWO_SIDED|95.0|-0.241|-0.012|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.012|-0.241|0.0305
71654855|NCT01172821|142827529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.059||0.1602|TWO_SIDED|95.0|-0.198|0.033|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.033|-0.198|0.1602
71654856|NCT01172821|142827530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4012|TWO_SIDED|95.0|0.81|1.74||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.74|0.81|0.4012
71654857|NCT01172821|142827530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||1.1727|TWO_SIDED|95.0|0.67|1.42||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.42|0.67|1.1727
71654858|NCT01172821|142827531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.613|STANDARD_ERROR_OF_MEAN|4.496|<|0.0001|TWO_SIDED|95.0|11.795|29.431|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||29.431|11.795|<0.0001
71654859|NCT01172821|142827531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.757|STANDARD_ERROR_OF_MEAN|4.513|<|0.0001|TWO_SIDED|95.0|15.907|33.607|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.607|15.907|<0.0001
71654860|NCT01172821|142827532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.991|STANDARD_ERROR_OF_MEAN|4.547||0.0004|TWO_SIDED|95.0|7.074|24.908|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||24.908|7.074|0.0004
71654861|NCT01172821|142827532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.247|STANDARD_ERROR_OF_MEAN|4.561|<|0.0001|TWO_SIDED|95.0|12.302|30.193|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||30.193|12.302|<0.0001
71654862|NCT01172821|142827533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.953|STANDARD_ERROR_OF_MEAN|0.598||0.1114|TWO_SIDED|95.0|-2.125|0.22|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.220|-2.125|0.1114
71707867|NCT02662582|142933766|SUPERIORITY||LSMean difference|-0.5||||0.255|TWO_SIDED|90.0|-1.3|0.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Dyspnea) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.2|-1.3|0.255
71707868|NCT02662582|142933766|SUPERIORITY||LSMean difference|-0.2||||0.651|TWO_SIDED|90.0|-1.1|0.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.6|-1.1|0.651
71707869|NCT02662582|142933766|SUPERIORITY||LSMean difference|-0.3||||0.591|TWO_SIDED|90.0|-1.0|0.5||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Borg (Leg Effort) at isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.5|-1.0|0.591
71707870|NCT02662582|142933767|SUPERIORITY||LSMean difference|0.0286||||0.04|TWO_SIDED|90.0|0.0061|0.0511||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0511|0.0061|0.040
71707871|NCT02662582|142933767|SUPERIORITY||LSMean differencce|0.0185||||0.155|TWO_SIDED|90.0|-0.0031|0.0401||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0401|-0.0031|0.155
71707872|NCT02662582|142933768|SUPERIORITY||LSMean difference|0.001||||0.972|TWO_SIDED|90.0|-0.0459|0.0479||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0479|-0.0459|0.972
71707873|NCT02662582|142933768|SUPERIORITY||LSMean difference|-0.0118||||0.578|TWO_SIDED|90.0|-0.0471|0.0236||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0236|-0.0471|0.578
71707874|NCT02662582|142933769|SUPERIORITY||LSMean difference|-0.65||||0.235|TWO_SIDED|90.0|-1.55|0.26||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.26|-1.55|0.235
71707875|NCT02662582|142933769|SUPERIORITY||LSMean differencce|-0.57||||0.215|TWO_SIDED|90.0|-1.33|0.19||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.19|-1.33|0.215
71707876|NCT02662582|142933770|SUPERIORITY||LSMean difference|0.7||||0.28|TWO_SIDED|90.0|-0.38|1.77||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.77|-0.38|0.280
71707877|NCT02662582|142933770|SUPERIORITY||LSMean difference|0.46||||0.424|TWO_SIDED|90.0|-0.49|1.4||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.40|-0.49|0.424
71707878|NCT02662582|142933771|SUPERIORITY||LSMean difference|0.039||||0.187|TWO_SIDED|90.0|-0.0099|0.0879||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.0879|-0.0099|0.187
71707879|NCT02662582|142933771|SUPERIORITY||LSMean difference|0.0488||||0.213|TWO_SIDED|90.0|-0.0163|0.114||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.1140|-0.0163|0.213
71707880|NCT02662582|142933772|SUPERIORITY||LSMean difference|-0.4||||0.64||90.0|-2.1|1.2||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.2|-2.1|0.640
71707881|NCT02662582|142933772|SUPERIORITY||LSMean difference|-0.7||||0.487|TWO_SIDED|90.0|-2.5|1.1||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.1|-2.5|0.487
71707882|NCT02662582|142933773|SUPERIORITY||LSMean difference|0.095||||0.1|TWO_SIDED|90.0|0.0|0.189||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.189|0.000|0.100
71707883|NCT02662582|142933773|SUPERIORITY||LSMean difference|0.133||||0.008|TWO_SIDED|90.0|0.053|0.213||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.213|0.053|0.008
71886588|NCT01340209|143293511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.048||0.0203|TWO_SIDED|95.0|0.018|0.207|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.207|0.018|0.0203
71886589|NCT01340209|143293512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4944|TWO_SIDED|95.0|-0.141|0.068|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||0.068|-0.141|0.4944
71654863|NCT01172821|142827533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.6||0.7665|TWO_SIDED|95.0|-1.355|0.999|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.999|-1.355|0.7665
71654864|NCT01172821|142827534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.031||0.0111|TWO_SIDED|95.0|0.018|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.018|0.0111
71654865|NCT01172821|142827534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.031||0.0395|TWO_SIDED|95.0|0.003|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.003|0.0395
71654866|NCT01172821|142827535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.032||0.0357|TWO_SIDED|95.0|0.005|0.131|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.131|0.005|0.0357
71654867|NCT01172821|142827535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.032||0.0422|TWO_SIDED|95.0|0.002|0.129|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.129|0.002|0.0422
71654868|NCT01172821|142827536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.131||0.1927|TWO_SIDED|95.0|-0.427|0.086|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.086|-0.427|0.1927
71654869|NCT01172821|142827536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.131||0.4053|TWO_SIDED|95.0|-0.148|0.367|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.367|-0.148|0.4053
71654870|NCT01172821|142827537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3501|TWO_SIDED|95.0|-0.079|0.028|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.028|-0.079|0.3501
71654871|NCT01172821|142827537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.028||0.8045|TWO_SIDED|95.0|-0.047|0.061|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.061|-0.047|0.8045
71654872|NCT01172821|142827538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
71654873|NCT01172821|142827538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
71654874|NCT01036490|142827541|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71654875|NCT01036490|142827542|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
71654876|NCT01036490|142827545|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
71654877|NCT01036490|142827546|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||||||0.58
71654878|NCT00603291|142827566|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.14|||<|0.0001|TWO_SIDED|95.0|2.05|4.8|||Regression, Logistic|Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum||||4.80|2.05|<0.0001
71654879|NCT00603291|142827567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.06|||<|0.0001|TWO_SIDED|95.0|-3.92|-2.2|||ANCOVA|||||-2.20|-3.92|<0.0001
71654880|NCT04495283|142827574|SUPERIORITY||LS Mean Difference|-114.43|STANDARD_ERROR_OF_MEAN|26.65|<|0.001|ONE_SIDED|90.0||-80.01|||ANOVA|||||-80.01||<0.001
71654881|NCT04495283|142827575|SUPERIORITY||LS Mean Difference|-70.16|STANDARD_ERROR_OF_MEAN|21.549|<|0.001|ONE_SIDED|90.0||-42.32|||ANOVA|||||-42.32||<0.001
71654882|NCT02246439|142827621|SUPERIORITY||Odds Ratio (OR)|1.6081||||0.0406|TWO_SIDED|95.0|1.0194|2.5368||"This P-Value is for the All ages group"|Cochran-Mantel-Haenszel|Stratified by age.||The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the 'All ages' category, the odds ratio and p-value were stratified by age.||2.5368|1.0194|0.0406
71707884|NCT02662582|142933774|SUPERIORITY||LSMean difference|0.051||||0.408|TWO_SIDED|90.0|-0.052|0.154||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.154|-0.052|0.408
71654883|NCT02246439|142827621|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0729|TWO_SIDED|95.0|0.847|27.2024||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||27.2024|0.8470|0.0729
71707885|NCT02662582|142933774|SUPERIORITY||LSMean difference|0.094||||0.058|TWO_SIDED|90.0|0.013|0.174||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.174|0.013|0.058
71707886|NCT02662582|142933775|SUPERIORITY||LSMean difference|1.44||||0.648|TWO_SIDED|90.0|-3.85|6.73||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||6.73|-3.85|0.648
71707887|NCT02662582|142933775|SUPERIORITY||LSMean difference|0.85||||0.775|TWO_SIDED|90.0|-4.12|5.82||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.82|-4.12|0.775
71707888|NCT02662582|142933776|SUPERIORITY||LSMean difference|1.1||||0.544|TWO_SIDED|90.0|-1.9|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-1.9|0.544
71707889|NCT02662582|142933776|SUPERIORITY||LSMean difference|2.1||||0.216|TWO_SIDED|90.0|-0.7|5.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||5.0|-0.7|0.216
71654884|NCT02246439|142827621|SUPERIORITY||Odds Ratio (OR)|1.4755||||0.1089|TWO_SIDED|95.0|0.917|2.3741||"This P-Value is for the 18 years of age and older group"|Cochran-Mantel-Haenszel|||||2.3741|0.9170|0.1089
71654885|NCT02246439|142827622|SUPERIORITY||Odds Ratio (OR)|1.3545||||0.1843|TWO_SIDED|95.0|0.8647|2.1216|||Cochran-Mantel-Haenszel|Stratified by age.||||2.1216|0.8647|0.1843
71654886|NCT02246439|142827623|SUPERIORITY||Odds Ratio (OR)|1.752||||0.0166|TWO_SIDED|95.0|1.1058|2.776|||Cochran-Mantel-Haenszel|Stratified by age.||||2.7760|1.1058|0.0166
71654887|NCT02246439|142827624|SUPERIORITY||Odds Ratio (OR)|0.6677||||0.1049|TWO_SIDED|95.0|0.4093|1.0892|||Cochran-Mantel-Haenszel|Stratified by age.||||1.0892|0.4093|0.1049
71654888|NCT02246439|142827625|SUPERIORITY||Odds Ratio (OR)|0.6566||||0.1235|TWO_SIDED|95.0|0.3826|1.1268|||Cochran-Mantel-Haenszel|Stratified by age.||||1.1268|0.3826|0.1235
71654889|NCT02246439|142827627|SUPERIORITY|||||||0.589||||||This P-Value is for the BSS=7 group.|Wilcoxon (Mann-Whitney)|||||||0.5890
71654890|NCT02246439|142827628|SUPERIORITY||Hazard Ratio (HR)|0.9782||||0.8487|TWO_SIDED|95.0|0.7803|1.2264||"This P-Value is for the All ages group."|Cox proportioanl hazards method|Stratified by age.||||1.2264|0.7803|0.8487
71654891|NCT02246439|142827628|SUPERIORITY||Hazard Ratio (HR)|1.4756||||0.3479|TWO_SIDED|95.0|0.6549|3.325||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.3250|0.6549|0.3479
71654892|NCT02246439|142827628|SUPERIORITY||Hazard Ratio (HR)|0.9445||||0.6332|TWO_SIDED|95.0|0.7469|1.1943||"This P-Value is for the 18 years of age of older group."|Cox proportional hazards method|||||1.1943|0.7469|0.6332
71654893|NCT02246439|142827629|SUPERIORITY||Hazard Ratio (HR)|1.0275||||0.8289|TWO_SIDED|95.0|0.8036|1.3138||"This P-Value was for the All ages group."|Cox proportional hazards method|Stratified by age.||||1.3138|0.8036|0.8289
71654894|NCT02246439|142827629|SUPERIORITY||Hazard Ratio (HR)|1.5744||||0.3241|TWO_SIDED|95.0|0.6388|3.8802||"This P-Value is for the \<18 years of age group."|Cox proportional hazards method|||||3.8802|0.6388|0.3241
71654895|NCT02246439|142827629|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9511|TWO_SIDED|95.0|0.7688|1.2801||"This P-Value is for the 18 years of age or older group."|Cox proportional hazards method|||||1.2801|0.7688|0.9511
71654896|NCT02246439|142827630|SUPERIORITY||Odds Ratio (OR)|2.3012||||0.2005|TWO_SIDED|95.0|0.6221|8.5129|||Cochran-Mantel-Haenszel|||||8.5129|0.6221|0.2005
71654897|NCT02246439|142827631|SUPERIORITY||Odds Ratio (OR)|0.6674||||0.572|TWO_SIDED|95.0|0.1638|2.7191|||Cochran-Mantel-Haenszel|||||2.7191|0.1638|0.5720
71654898|NCT02246439|142827632|SUPERIORITY||Odds Ratio (OR)|2.1591||||0.3186|TWO_SIDED|95.0|0.477|9.7735||"This P-Value is for the No nausea or mild nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||9.7735|0.4770|0.3186
71654899|NCT02246439|142827632|SUPERIORITY||Odds Ratio (OR)|1.575||||0.3473|TWO_SIDED|95.0|0.6096|4.0696||"This P-Value is for the Moderate nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0696|0.6096|0.3473
71654900|NCT02246439|142827632|SUPERIORITY||Odds Ratio (OR)|2.0971||||0.0633|TWO_SIDED|95.0|0.9614|4.5747||"This P-Value is for the Severe nausea group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.5747|0.9614|0.0633
71654901|NCT02246439|142827632|SUPERIORITY||Odds Ratio (OR)|1.6397||||0.2797|TWO_SIDED|95.0|0.6649|4.0437||"This P-Value is for the Nausea as bad as it could have been group."|Cochran-Mantel-Haenszel|Stratified by age.||||4.0437|0.6649|0.2797
71654902|NCT02246439|142827633|SUPERIORITY||Odds Ratio (OR)|1.8673||||0.0103|TWO_SIDED|95.0|1.1572|3.0131||"This P-Value is for the All ages group."|Cochran-Mantel-Haenszel|Stratified by age.||||3.0131|1.1572|0.0103
71707890|NCT02662582|142933777|SUPERIORITY||LSMean difference|-7.4||||0.171|TWO_SIDED|90.0|-16.5|1.6||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||1.6|-16.5|0.171
71707891|NCT02662582|142933777|SUPERIORITY||LSMean difference|0.2||||0.976|TWO_SIDED|90.0|-10.3|10.7||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||10.7|-10.3|0.976
71707892|NCT02662582|142933778|SUPERIORITY||LSMean difference|-0.6||||0.844|TWO_SIDED|90.0|-6.1|4.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.9|-6.1|0.844
71707893|NCT02662582|142933778|SUPERIORITY||LSMean difference|-0.9||||0.751|TWO_SIDED|90.0|-5.8|4.0||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||4.0|-5.8|0.751
71707894|NCT02662582|142933779|SUPERIORITY||LSMean difference|0.2||||0.59|TWO_SIDED|90.0|-0.5|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.5|0.590
71707895|NCT02662582|142933779|SUPERIORITY||LSMean difference|0.3||||0.399|TWO_SIDED|90.0|-0.3|0.9||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.9|-0.3|0.399
71707896|NCT02662582|142933780|SUPERIORITY||LSMean difference|-0.09||||0.151|TWO_SIDED|90.0|-0.2|0.01||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.01|-0.20|0.151
71707897|NCT02662582|142933781|SUPERIORITY||LSMean difference|-0.007||||0.857|TWO_SIDED|90.0|-0.07|0.056||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||0.056|-0.070|0.857
71707898|NCT02662582|142933782|SUPERIORITY||LSMean difference|1.56||||0.11|TWO_SIDED|90.0|-0.05|3.17||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||3.17|-0.05|0.110
71707899|NCT02662582|142933783|SUPERIORITY||LSMean difference|2.07||||0.766|TWO_SIDED|90.0|-9.57|13.71||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Peak: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.71|-9.57|0.766
71707900|NCT02662582|142933783|SUPERIORITY||LSMean difference|2.94||||0.642|TWO_SIDED|90.0|-7.66|13.54||Statistical comparison was performed at a 2-sided 0.10 significance level.|Mixed Models Analysis|||Isotime: LSMeans, LSMean difference of CK-2127107 minus placebo, and 90% confidence intervals are based on a mixed effect model with treatment and period as fixed effects, subject as a random effect, and a compound symmetry covariance structure.||13.54|-7.66|0.642
71707901|NCT02739828|142933811|SUPERIORITY|||||||0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0001
71707902|NCT02739828|142933812|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||< 0.0001
71707903|NCT02739828|142933813|SUPERIORITY|||||||0.0004|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
71707904|NCT02739828|142933814|SUPERIORITY|||||||0.0005|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0005
71707905|NCT02739828|142933814|SUPERIORITY|||||||0.0006|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0006
71707906|NCT02739828|142933815|SUPERIORITY|||||||0.0004|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0004
71707907|NCT02739828|142933815|SUPERIORITY|||||||0.0016|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0016
71707908|NCT02739828|142933816|SUPERIORITY|||||||0.0003|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0003
71707909|NCT02739828|142933816|SUPERIORITY|||||||0.0094|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0094
71707910|NCT02739828|142933820|SUPERIORITY|||||||0.0278|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0278
71707911|NCT02739828|142933821|SUPERIORITY|||||||0.0215|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0215
71707912|NCT02739828|142933822|SUPERIORITY|||||||0.1652|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1652
71654903|NCT02246439|142827633|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0934|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0934
71654904|NCT02246439|142827633|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
71654905|NCT02246439|142827634|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0924|TWO_SIDED|95.0|0.7699|25.145||"This P-Value is for the \<18 years of age group."|Cochran-Mantel-Haenszel|||||25.1450|0.7699|0.0924
71654906|NCT02246439|142827634|SUPERIORITY||Odds Ratio (OR)|1.7356||||0.0303|TWO_SIDED|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel|||||2.8615|1.0527|0.0303
71654907|NCT02246439|142827635|SUPERIORITY||Odds Ratio (OR)|1.7922||||0.0152|TWO_SIDED|95.0|1.1188|2.871|||Regression, Logistic|||||2.8710|1.1188|0.0152
71654908|NCT02246439|142827636|SUPERIORITY||Odds Ratio (OR)|2.0789||||0.0037|TWO_SIDED|95.0|1.2676|3.4095|||Regression, Logistic|||||3.4095|1.2676|0.0037
71654909|NCT00380692|142827664|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.0|-3.4||P-value for treatment group differences over time.|Mixed Models Analysis|||||-3.4|-10.0|<0.001
71654910|NCT00380692|142827665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.921||95.0|-0.5|0.4||P-value for treatment differences over time.|Mixed Models Analysis|||||0.4|-0.5|0.921
71654911|NCT00380692|142827666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.369||95.0|-1.8|0.7||P-value for treatment differences in Oppositional Score at 8 weeks.|ANCOVA|||||0.7|-1.8|0.369
71654912|NCT00380692|142827666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.024||95.0|-3.7|-0.3||P-value for treatment differences in Hyperactivity score at 8 weeks|ANCOVA|||||-0.3|-3.7|0.024
71654913|NCT00380692|142827666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.51||0.179||95.0|-1.7|0.3||P-value for treatment differences in Cognititve/Attention score at 8 weeks.|ANCOVA|||||0.3|-1.7|0.179
71654914|NCT00380692|142827666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.48||0.077||95.0|-5.6|0.3||P-value for treatment differences in ADHD score at 8 weeks|ANCOVA|||||0.3|-5.6|0.077
71654915|NCT00380692|142827668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.028||95.0|-1.0|-0.1||P-value for treatment differences in Time to fall asleep score at 8 weeks.|ANCOVA|||||-0.1|-1.0|0.028
71654916|NCT00380692|142827668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.407||95.0|-0.3|0.9||P-value for treatment differences in Difficulty falling asleep score at 8 weeks.|ANCOVA|||||0.9|-0.3|0.407
71654917|NCT00380692|142827668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.652||95.0|-0.6|0.4||P-value for treatment differences in Total hours of sleep score at 8 weeks.|ANCOVA|||||0.4|-0.6|0.652
71654918|NCT00380692|142827668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.49||0.112||95.0|-1.7|0.2||P-value for treatment differences in Quality of sleep score at 8 weeks.|ANCOVA|||||0.2|-1.7|0.112
71654919|NCT00380692|142827668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.87||0.188||95.0|-2.9|0.6||P-value for treatment differences in Functional outcome during day score at 8 weeks.|ANCOVA|||||0.6|-2.9|0.188
71654920|NCT00380692|142827669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|1.29||0.452||95.0|-3.5|1.6||P-value for treatment differences in Irritability score at 8 weeks.|ANCOVA|||||1.6|-3.5|0.452
71654921|NCT00380692|142827669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|1.1||0.85||95.0|-2.4|2.0||P-value for treatment differences in Lethargy score at 8 weeks.|ANCOVA|||||2.0|-2.4|0.850
71654922|NCT00380692|142827669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.63||0.014||95.0|-2.8|-0.3||P-value for treatment differences in Stereotypic score at 8 weeks.|ANCOVA|||||-0.3|-2.8|0.014
71654923|NCT00380692|142827669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|1.68||0.01||95.0|-7.8|-1.1||P-value for treatment differences in Hyperactivity score at 8 weeks.|ANCOVA|||||-1.1|-7.8|0.010
71654924|NCT00380692|142827669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.045||95.0|-1.7|0.0||P-value for treatment differences in Inappropriate speech score at 8 weeks.|ANCOVA|||||-0.0|-1.7|0.045
71654925|NCT00380692|142827670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|2.13||0.069||95.0|-8.1|0.3||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.3|-8.1|0.069
71654926|NCT00380692|142827671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.598||95.0|-1.6|0.9||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||0.9|-1.6|0.598
71654927|NCT00380692|142827672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|STANDARD_ERROR_OF_MEAN|11.12||0.318||95.0|-33.3|11.0||P-value for treatment differences in Total score at 8 weeks.|ANCOVA|||||11.0|-33.3|0.318
71654928|NCT00380692|142827673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.7||0.948||95.0|-5.5|5.2||P-value for treatment differences in Error Rate over time.|Mixed Models Analysis|||||5.2|-5.5|0.948
71654929|NCT00380692|142827673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.5||0.399||95.0|-9.7|3.9||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||3.9|-9.7|0.399
71654930|NCT00380692|142827673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_DEVIATION|3.1||0.57||95.0|-4.3|7.8||P-value for Treatment\*Condition Error Rate relevant nontargets over time.|Mixed Models Analysis|||||7.8|-4.3|0.570
71654931|NCT00380692|142827674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.9|STANDARD_ERROR_OF_MEAN|66.0||0.352||95.0|-193.5|69.8||P-value for Treatment differences in Reaction time over time.|Mixed Models Analysis|||||69.8|-193.5|0.352
71654932|NCT00380692|142827674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.1|STANDARD_ERROR_OF_MEAN|62.3||0.553||95.0|-160.3|86.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections irrelevant target over time.|Mixed Models Analysis|||||86.2|-160.3|0.553
71654933|NCT00380692|142827674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_ERROR_OF_MEAN|57.7||0.904||95.0|-107.1|121.1||P-value for Treatment\*Condition Mean Reaction Time correct rejections relevant nontarget over time.|Mixed Models Analysis|||||121.1|-107.1|0.904
71765056|NCT00791817|143032689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3897|||||TWO_SIDED|90.0|1.1998|1.6097||||Confidence Interval is on the Ratio of Fed to Fasted|Confidence Interval is on the Ratio of Fed to Fasted|values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted||1.6097|1.1998|
71765057|NCT01134705|143032705|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.2|-0.5||A priori threshold for statistical significance is p\<0.05|Repeated measures Analysis of covariance|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.2|<0.001
71765058|NCT01134705|143032706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||A priori threshold for statistical significance is p\<0.05|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
71765059|NCT01134705|143032707|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.001|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|ANCOVA with treatment, baseline and center in the model.||||-0.2|-0.9|0.001
71765060|NCT02874144|143032709|SUPERIORITY|intention-to-treat with participants analyzed according to a randomly assigned treatment group irrespective of compliance.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.05|TWO_SIDED|||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Regression, Linear|||We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time compare relative rate of change over time between scores within the treatment group (AZD1981 plus INCS) and within the to scores within the placebo group (INCS treatment only)..|For inflammatory mediator analyses, data were reported as mean (SEM) with statistical significance determined by Kruskal-Wallis test.|||<0.05
71765061|NCT02874144|143032709|SUPERIORITY|This was a superiority trial. We used repeated-measures linear regression using the mixed procedure to calculate means for each outcome by visits and treatment status. We used baseline scores to track change to follow-up scores and used a difference-in-differences (D-I-D) statistical approach to compare the change over time between scores within the treatment group (AZD1981 plus INCS) to scores within the placebo group (INCS treatment only).|Mean Difference (Final Values)|-20.0|||<|0.05|TWO_SIDED|||||No, the p-value was not adjusted for multiple comparisons.|repeated-measures linear regression|We used repeated-measures linear regression using the MIXED procedure to calculate means (SEMS) for each outcome by visits and treatment status.|Our study did not include at relative risk.|The trial design is a continuous outcome superiority trial with primary efficacy outcome measures of change in Total Polyp Score (TPS) comparing AZD to placebo arm from V1 to V5. Total polyp score is a standardized method for assessing nasal polyp size by endoscopy, based on a scale of 1-4 per side. Inclusion criterion for this study is a TPS of ≥4 with a maximum of 8 and a standard deviation ± 2. A clinically meaningful effect is considered to be a decrease in total polyp score of 1.5.||||<0.05
71765062|NCT02975557|143032721|OTHER|||||||1|||||||Fisher Exact|The type I error was adjusted by using the alpha spending function approach with O'Brien-Fleming type boundaries.||We evaluated if the categorical type of tolerability measure is different between control (Artificial Tears) and intervention (Brimonidine, including both 0.15% high and 0.075% low doses groups).||||1
71765063|NCT01578850|143032722|SUPERIORITY_OR_OTHER||Difference in Proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).|Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.|||35.81|16.78|<0.001
71765064|NCT01578850|143032723|SUPERIORITY_OR_OTHER||Difference in proportions|23.7||||0.019|TWO_SIDED|95.0|6.83|40.61|||Cochran-Mantel-Haenszel|The p-value from CMH test of general association was stratified by geographic region.||||40.61|6.83|0.019
71765065|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|-0.6||||0.371|TWO_SIDED|95.0|-1.76|0.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Baseline||0.57|-1.76|0.371
71765066|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Baseline||1.81|-0.59|0.358
71765067|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|2.6||||0.667|TWO_SIDED|95.0|-4.76|9.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||9.98|-4.76|0.667
71765068|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||32.02|10.99|0.001
71654934|NCT00380692|142827675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|65.9||0.748||95.0|-152.8|110.3||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||110.3|-152.8|0.748
71765069|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.004|TWO_SIDED|95.0|8.81|29.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||29.10|8.81|0.004
71765070|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.79|40.83|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||40.83|20.79|<0.001
71765071|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.89|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||37.54|16.89|<0.001
71765072|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.51|41.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||41.08|21.51|<0.001
71707913|NCT02739828|142933826|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
71707914|NCT02739828|142933827|SUPERIORITY|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||1.0000
71707915|NCT02739828|142933828|SUPERIORITY|||||||0.5|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.5000
71707916|NCT02739828|142933829|SUPERIORITY|||||||0.1797|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1797
71707917|NCT02739828|142933830|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
71707918|NCT02739828|142933831|SUPERIORITY|||||||0.0313|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0313
71707919|NCT02739828|142933832|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
71707920|NCT02739828|142933833|SUPERIORITY|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.4531
71707921|NCT02739828|142933834|SUPERIORITY|||||||0.0156|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0156
71707922|NCT02739828|142933835|SUPERIORITY|||||||0.0386|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0386
71707923|NCT02739828|142933836|SUPERIORITY|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.3438
71707924|NCT02739828|142933837|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
71707925|NCT02739828|142933838|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
71707926|NCT02739828|142933839|SUPERIORITY|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.0625
71707927|NCT02739828|142933840|SUPERIORITY|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).||||0.1250
71707928|NCT01953354|142933842|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
71707929|NCT01953354|142933843|SUPERIORITY_OR_OTHER|||||||1||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||1.000
71707930|NCT01953354|142933844|SUPERIORITY_OR_OTHER|||||||0.242||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.242
71707931|NCT01953354|142933845|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
71707932|NCT01953354|142933848|SUPERIORITY_OR_OTHER|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.550
71707933|NCT01953354|142933849|SUPERIORITY_OR_OTHER|||||||0.633||||||P-value is testing for a difference in proportions using a Fisher's exact test.|Fisher Exact|||||||0.633
71707934|NCT02965976|142933863|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
71707935|NCT02965976|142933864|SUPERIORITY|||||||0.773|||||||Cochran-Mantel-Haenszel|||||||0.773
71707936|NCT02965976|142933865|SUPERIORITY|||||||0.368|||||||t-test, 2 sided|||||||0.368
71707937|NCT02965976|142933866|SUPERIORITY|||||||0.987|||||||t-test, 2 sided|||||||0.987
71707938|NCT02965976|142933867|SUPERIORITY|||||||0.423|||||||Cochran-Mantel-Haenszel|||||||0.423
71707939|NCT02965976|142933868|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.000
71707940|NCT00806026|142933871|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-4.5|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-5.9|-3.2||This analysis was step 1 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region \[United states (US) or European union (EU)\], treatment, week and treatment by week interaction as fixed effects.||-3.20|-5.90|<0.0001
71707941|NCT00806026|142933871|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3603|TWO_SIDED|95.0|-2.0|0.7||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.7|-2.0|0.3603
71707942|NCT00806026|142933871|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.5|-1.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-1.9|-4.5|<0.0001
71707943|NCT00806026|142933872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||This analysis was step 2 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pregabalin 300 mg versus placebo: Cochran-Mantel-Haenszel (CMH) test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||<0.0001
71707944|NCT00806026|142933872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4393|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.25 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.4393
71826415|NCT00678795|143157402|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.85||||0.007|TWO_SIDED|95.0|-1.47|-0.23|||ANCOVA|||The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.||-0.23|-1.47|0.007
71826416|NCT00404079|143157410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|STANDARD_DEVIATION|4.0||0.05|||||||Mixed Models Analysis|||Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models||||0.05
71826417|NCT00404079|143157410|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|||||||0.05
71654935|NCT00380692|142827675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-80.9|STANDARD_ERROR_OF_MEAN|77.5||0.299||95.0|-234.3|72.5||P-value for Treatment\*Condition Standard Deviation correct rejections irrelevant target over time.|Mixed Models Analysis|||||72.5|-234.3|0.299
71654936|NCT00380692|142827675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.6|STANDARD_ERROR_OF_MEAN|67.1||0.84||95.0|-119.3|146.5||P-value for Treatment\*Condition Standard Deviation correct rejections relevant nontarget over time.|Mixed Models Analysis|||||146.5|-119.3|0.840
71654937|NCT00380692|142827676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.8||0.126||95.0|-1.2|9.9||P-value for Treatment differences in Error Rate over time.|Mixed Models Analysis|||||9.9|-1.2|0.126
71654938|NCT00380692|142827676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.7||0.297||95.0|-5.2|1.6||P-value for Treatment\*Error Rate absent over time.|Mixed Models Analysis|||||1.6|-5.2|0.297
71654939|NCT00380692|142827676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|2.1||0.023||95.0|-9.4|-0.7||P-value for Treatment\*Targets Load 1 over time.|Mixed Models Analysis|||||-0.7|-9.4|0.023
71654940|NCT00380692|142827677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.2|STANDARD_ERROR_OF_MEAN|71.7||0.228||95.0|-230.4|56.0||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||56.0|-230.4|0.228
71654941|NCT00380692|142827677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|87.6|STANDARD_ERROR_OF_MEAN|77.3||0.26||95.0|-65.6|240.8||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 1 over time.|Mixed Models Analysis|||||240.8|-65.6|0.260
71654942|NCT00380692|142827677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|70.4|STANDARD_ERROR_OF_MEAN|59.5||0.239||95.0|-47.3|188.2||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||188.2|-47.3|0.239
71654943|NCT00380692|142827677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.7|STANDARD_ERROR_OF_MEAN|80.1||0.128||95.0|-35.9|281.4||P-value for Treatment\*Condition Mean Reaction Time hits Load 1 over time.|Mixed Models Analysis|||||281.4|-35.9|0.128
71654944|NCT00380692|142827678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-175.5|STANDARD_ERROR_OF_MEAN|88.0||0.051||95.0|-351.5|0.5||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis|||||0.5|-351.5|0.051
71654945|NCT00380692|142827678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|218.1|STANDARD_ERROR_OF_MEAN|90.8||0.018||95.0|38.0|398.2||P-value for Treatment\*Condition Standard Deviation correct rejections Load 1 over time.|Mixed Models Analysis|||||398.2|38.0|0.018
71654946|NCT00380692|142827678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|173.6|STANDARD_ERROR_OF_MEAN|105.6||0.103||95.0|-35.7|383.0||P-value for Treatment\*Condition Standard Deviation correct rejections Load 2 over time.|Mixed Models Analysis|||||383.0|-35.7|0.103
71654947|NCT00380692|142827678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|205.5|STANDARD_ERROR_OF_MEAN|99.9||0.042||95.0|7.5|403.6||P-value for Treatment\*Condition Standard Deviation hits Load 1 over time.|Mixed Models Analysis|||||403.6|7.5|0.042
71654948|NCT00380692|142827679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.3|STANDARD_ERROR_OF_MEAN|4.6||0.128||95.0|-16.9|2.3||P-value for Treatment difference in Accuracy over time.|Mixed Models Analysis|||||2.3|-16.9|0.128
71654949|NCT00380692|142827680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.4||0.022||95.0|-11.2|-1.0||P-value for Treatment difference in Stability of Movement over time.|Mixed Models Analysis|||||-1.0|-11.2|0.022
71654950|NCT00380692|142827681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.0||0.43||95.0|-2.4|5.7||P-value for Treatment difference in Error Rate over time.|Mixed Models Analysis|||||5.7|-2.4|0.430
71654951|NCT00380692|142827681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0|STANDARD_ERROR_OF_MEAN|2.4||0.005||95.0|-11.8|-2.2||P-value for Treatment\*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis|||||-2.2|-11.8|0.005
71654952|NCT00380692|142827682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.9||0.221||95.0|-9.6|2.3||P-value for Treatment differences in Error Rates over time.|Mixed Models Analysis|||||2.3|-9.6|0.221
71654953|NCT00380692|142827682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.0||0.307||95.0|-2.1|6.3||P-value for Treatment\*Condition Error Rates compatible signals over time.|Mixed Models Analysis|||||6.3|-2.1|0.307
71654954|NCT00380692|142827683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|68.9||0.752||95.0|-163.1|119.1||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis|||||119.1|-163.1|0.752
71654955|NCT00380692|142827683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.6|STANDARD_ERROR_OF_MEAN|31.9||0.564||95.0|-47.0|84.3||P-value for Treatment\*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis|||||84.3|-47.0|0.564
71654956|NCT02177136|142827760|SUPERIORITY|||||||0.0434|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0434
71654957|NCT02177136|142827760|SUPERIORITY|||||||0.0665|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.||||||0.0665
71654958|NCT01032018|142827821|SUPERIORITY_OR_OTHER||Difference of back-transformed means.|-3.5||||0.01||95.0|-6.1|-0.7|||Mixed Models Analysis|||The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.||-0.7|-6.1|0.01
71707945|NCT00806026|142933872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|||||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.5 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.||||0.0022
71707946|NCT00806026|142933873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0826|TWO_SIDED|||||This analysis was step 6 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.25 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0826
71707947|NCT00806026|142933873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||This analysis was step 3 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.5 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.||||0.0012
71707948|NCT00806026|142933875|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.25|STANDARD_ERROR_OF_MEAN|4.332|<|0.0001|TWO_SIDED|95.0|-25.76|-8.74||This analysis was step 7 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-8.74|-25.76|<0.0001
71707949|NCT00806026|142933875|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|4.408||0.8075|TWO_SIDED|95.0|-9.73|7.58||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||7.58|-9.73|0.8075
71707950|NCT00806026|142933875|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.57|STANDARD_ERROR_OF_MEAN|4.318||0.2906|TWO_SIDED|95.0|-13.05|3.91||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||3.91|-13.05|0.2906
71707951|NCT00806026|142933881|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.93||0.7073|TWO_SIDED|95.0|-9.3|6.3||This analysis was step 8 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||6.30|-9.30|0.7073
71707952|NCT00806026|142933881|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|3.78||0.5299|TWO_SIDED|95.0|-5.1|9.9||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||9.9|-5.1|0.5299
71707953|NCT00806026|142933881|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|3.69||0.0354|TWO_SIDED|95.0|-15.2|-0.5||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.5|-15.2|0.0354
71707954|NCT00806026|142933883|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|95.0|-1.55|-0.45||This analysis was step 9 in a step-down procedure (if p\<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||-0.45|-1.55|0.0004
71707955|NCT00806026|142933883|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.282||0.1242|TWO_SIDED|95.0|-0.99|0.12||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.12|-0.99|0.1242
71707956|NCT00806026|142933883|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.287||0.0553|TWO_SIDED|95.0|-1.12|0.01||This analysis was not included in the step-down procedure (if p\<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.||0.01|-1.12|0.0553
71707957|NCT00728182|142933933|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regression.||Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.||||0.445
71707958|NCT00728182|142933934|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.53||||0.018|TWO_SIDED|95.0|0.38|0.74|||Generalized linear model|With log link and negative bnomial distribution.||Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.||0.74|0.38|0.018
71707959|NCT00728182|142933935|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.59||||0.048|TWO_SIDED|95.0|0.42|0.83|||Generalized linear model|With log link and negative binomial distribution.||Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.||0.83|0.42|0.048
71707960|NCT00728182|142933936|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regresion.||Comparison of the summed volume of new ischemic lesions on DWI.||||0.306
71707961|NCT00728182|142933937|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.43|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.||1.1|0.9|0.43
71707962|NCT00728182|142933938|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.9|1.1|||Chi-squared|||Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.||1.1|0.9|1.00
71707963|NCT00728182|142933939|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|||||||0.023
71707964|NCT00728182|142933940|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.027|TWO_SIDED|95.0|0.17|0.73|||Adjusted Incidence Rate Ratio|||||0.73|0.17|0.027
71707965|NCT00728182|142933941|SUPERIORITY_OR_OTHER||Adjusted Incidence Rate Ratio|0.36||||0.046|TWO_SIDED|95.0|0.17|0.75|||Generalized linear model|||||0.75|0.17|0.046
71707966|NCT00728182|142933942|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
71707967|NCT00728182|142933943|SUPERIORITY_OR_OTHER||Relative Risk|1.5||||0.02|TWO_SIDED|95.0|1.1|2.0|||Chi-squared|||||2.0|1.1|0.02
71654959|NCT02130583|142827823|SUPERIORITY||Mean Difference (Net)|2.06||||0.034|TWO_SIDED||||||ANOVA|||||||.034
71654960|NCT03247517|142827835|SUPERIORITY||Least Square Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0232|TWO_SIDED|95.0|-8.4|-0.6|||Mixed Models for Repeated Measures|||||-0.6|-8.4|0.0232
71654961|NCT03247517|142827835|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0091|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Models for Repeated Measures|||||-1.3|-8.9|0.0091
71654962|NCT03247517|142827836|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0042|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0042
71654963|NCT03247517|142827836|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.9|0.0003
71654964|NCT03247517|142827837|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.54||0.6854|TWO_SIDED|95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.6854
71654965|NCT03247517|142827837|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.49||0.0518|TWO_SIDED|95.0|-5.8|0.0|||ANCOVA|||||0.0|-5.8|0.0518
71654966|NCT03247517|142827838|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.2062|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.2062
71654967|NCT03247517|142827838|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0519|TWO_SIDED|95.0|-0.23|0.0|||ANCOVA|||||0.00|-0.23|0.0519
71654968|NCT03247517|142827839|SUPERIORITY||Risk Difference (RD)|18.8||||0.0068|TWO_SIDED|95.0|5.5|32.2|||Regression, Logistic|||||32.2|5.5|0.0068
71654969|NCT03247517|142827839|SUPERIORITY||Risk Difference (RD)|17.6||||0.0095|TWO_SIDED|95.0|4.6|30.5|||Regression, Logistic|||||30.5|4.6|0.0095
71654970|NCT03247517|142827840|SUPERIORITY||Least Square Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.51||0.7629|TWO_SIDED|95.0|-9.1|12.5|||ANCOVA|||||12.5|-9.1|0.7629
71654971|NCT03247517|142827840|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.36||0.7648|TWO_SIDED|95.0|-12.1|8.9|||ANCOVA|||||8.9|-12.1|0.7648
71654972|NCT03247517|142827841|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.99||0.0069|TWO_SIDED|95.0|-4.6|-0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.7|-4.6|0.0069
71654973|NCT03247517|142827841|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.96||0.0005|TWO_SIDED|95.0|-5.2|-1.5|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.5|-5.2|0.0005
71654974|NCT03247517|142827841|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.05||0.0424|TWO_SIDED|95.0|-4.2|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.2|0.0424
71654975|NCT03247517|142827841|SUPERIORITY||Least Square Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.039|TWO_SIDED|95.0|-4.1|-0.1|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.1|-4.1|0.0390
71654976|NCT03247517|142827842|SUPERIORITY||Least Square Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3813|TWO_SIDED|95.0|-3.4|1.3|||ANCOVA|||||1.3|-3.4|0.3813
71654977|NCT03247517|142827842|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.17||0.9506|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA|||||2.2|-2.4|0.9506
71654978|NCT03247517|142827843|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 1||||0.0254
71654979|NCT03247517|142827843|SUPERIORITY|||||||0.0899|||||||Chi-squared|||This analysis pertains to Week 2||||0.0899
71654980|NCT03247517|142827843|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 3||||0.0070
71654981|NCT03247517|142827843|SUPERIORITY|||||||0.0031|||||||Chi-squared|||This analysis pertains to Week 4||||0.0031
71654982|NCT03247517|142827843|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 5||||0.0065
71654983|NCT03247517|142827843|SUPERIORITY|||||||0.007|||||||Chi-squared|||This analysis pertains to Week 6||||0.0070
71654984|NCT03247517|142827843|SUPERIORITY|||||||0.0063|||||||Chi-squared|||This analysis pertains to Week 1||||0.0063
71654985|NCT03247517|142827843|SUPERIORITY|||||||0.0123|||||||Chi-squared|||This analysis pertains to Week 2||||0.0123
71654986|NCT03247517|142827843|SUPERIORITY|||||||0.0003|||||||Chi-squared|||This analysis pertains to Week 3||||0.0003
71654987|NCT03247517|142827843|SUPERIORITY|||||||0.0001|||||||Chi-squared|||This analysis pertains to Week 4||||0.0001
71654988|NCT03247517|142827843|SUPERIORITY|||||||0.0025|||||||Chi-squared|||This analysis pertains to Week 5||||0.0025
71654989|NCT03247517|142827843|SUPERIORITY|||||||0.0033|||||||Chi-squared|||This analysis pertains to Week 6||||0.0033
71654990|NCT03265288|142827844|SUPERIORITY||Least square means difference|0.7716||||0.3449|TWO_SIDED|95.0|-0.8397|2.3828||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Primary analysis of the treatment effect at the Week 24 visit on the intent to treat population (ITT) Null hypothesis is no treatment difference||2.3828|-0.8397|0.3449
71654991|NCT03265288|142827844|SUPERIORITY||Least square means difference|1.0053||||0.0667|TWO_SIDED|95.0|-0.07|2.0807||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Analysis of the overall treatment effect from baseline through Week 24 in the intent to treat population (ITT), Null hypothesis is no treatment difference||2.0807|-0.0700|0.0667
71654992|NCT03265288|142827844|SUPERIORITY||Least square means difference|1.2258||||0.0486|TWO_SIDED|95.0|0.0078|2.4438||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|Secondary analysis of the overall treatment effect from baseline through Week 24 on the per protocol population (PP), null hypothesis is no treatment difference||2.4438|0.0078|0.0486
71654993|NCT03265288|142827844|SUPERIORITY||Least square means difference|2.6628||||0.0687|TWO_SIDED|95.0|-0.2069|5.5325||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor ppFEV1 (\<70% or ≥70%) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup ≥70%, n=29 (LAU-7b), n=27 (Placebo)"||5.5325|-0.2069|0.0687
71654994|NCT03265288|142827844|SUPERIORITY||Least square means difference|1.391||||0.236|TWO_SIDED|95.0|-0.922|3.7041||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for stratification factor co-administration of CFTR modulator (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving CFTR modulators, n=41 (LAU-7b), n=46 (Placebo)"||3.7041|-0.9220|0.236
71654995|NCT03265288|142827844|SUPERIORITY||Least square means difference|1.1302||||0.5323|TWO_SIDED|95.0|-2.4447|4.7052||alpha is set to 0.05|Mixed Model for Repeated Measures||A positive difference favours LAU-7b, a negative difference favours placebo.|"Secondary analysis of treatment effect at the Week 24 visit for à priori defined subgroup co-administration of ETI - elexacaftor/tezacaftor/ivacaftor (yes/no) in intent to treat population (ITT), null hypothesis is no treatment difference.~Here presented is the analysis for subgroup receiving ETI, n=18 (LAU-7b), n=23 (Placebo)"||4.7052|-2.4447|0.5323
71654996|NCT03265288|142827846|SUPERIORITY||Odds Ratio (OR)|0.5036||||0.1047|TWO_SIDED|95.0|0.2199|1.1532||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Arachidonic Acid (AA) during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||1.1532|0.2199|0.1047
71654997|NCT03265288|142827846|SUPERIORITY||Odds Ratio (OR)|0.8773||||0.7596|TWO_SIDED|95.0|0.3793|2.0291||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of Docosahexaenoic Acid (DHA) during treatment Intent to treat population (ITT, null hypothesis is no treatment effect||2.0291|0.3793|0.7596
71654998|NCT03265288|142827846|SUPERIORITY||Odds Ratio (OR)|1.0532||||0.8852|TWO_SIDED|95.0|0.5209|2.1296||alpha is set to 0.05|Regression, Logistic||Odds ratio \< 1 means lower odds of normalization with LAU-7b, odds ratio \> 1 means higher odds of normalization with LAU-7b|Highest normalization of AA/DHA ratio during treatment Intent to treat population (ITT), null hypothesis is no treatment effect||2.1296|0.5209|0.8852
71654999|NCT03265288|142827849|SUPERIORITY|||||||0.3025|||||||Log Rank|||||||0.3025
71655000|NCT03265288|142827850|SUPERIORITY||Risk Ratio (RR)|1.55||||0.3366|TWO_SIDED|95.0|0.63|3.8||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Protocol-Defined IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||3.80|0.63|0.3366
71655001|NCT03265288|142827850|OTHER||Risk Ratio (RR)|1.34||||0.3936|TWO_SIDED|95.0|0.68|2.64||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|ALL IV antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||2.64|0.68|0.3936
71655002|NCT03265288|142827850|SUPERIORITY||Risk Ratio (RR)|1.16||||0.5011|TWO_SIDED|95.0|0.75|1.79||alpha is set to 0.05|Regression, Cox||Odds ratio \< 1 means lower odds of a pulmonary exacerbation with LAU-7b, odds ratio close to 1 means similar odds of a pulmonary exacerbation for LAU-7b and placebo, odds ratio \> 1 means higher odds of a pulmonary exacerbation with LAU-7b|Combined IV- or Oral antibiotics-treated pulmonary exacerbation events. Intent to treat population (ITT), null hypothesis is no treatment effect||1.79|0.75|0.5011
71655003|NCT03265288|142827851|SUPERIORITY|||||||0.1955|||||||Log Rank|||||||0.1955
71655004|NCT03265288|142827852|SUPERIORITY||Risk Ratio (RR)|1.35||||0.1909|TWO_SIDED|95.0|0.86|2.12||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds of an antibiotic treatment with LAU-7b, odds ratio \> 1 means higher odds of an antibiotic treatment with LAU-7b|Number per subject of intravenous antibiotic treatments required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations Intent to treat population (ITT), null hypothesis is no treatment effect||2.12|0.86|0.1909
71655005|NCT03265288|142827853|SUPERIORITY||Risk Ratio (RR)|1.11||||0.7473|TWO_SIDED|95.0|0.6|2.04||alpha is set to 0.05|Poisson regression||Odds ratio \< 1 means lower odds in terms of days of antibiotics with LAU-7b, odds ratio close to 1 means similar odds in terms of days of antibiotics with LAU-7b or placebo, odds ratio \> 1 means higher odds in terms of days of antibiotics with LAU-7b|Number of days of intravenous antibiotics required for a pulmonary exacerbation, excludes Cycle 1 pulmonary exacerbations, Intent to treat population (ITT), null hypothesis is no treatment effect||2.04|0.60|0.7473
71707968|NCT00728182|142933944|SUPERIORITY_OR_OTHER||Relative Risk|1.3||||0.18|TWO_SIDED|95.0|0.95|1.7|||Chi-squared|||||1.7|0.95|0.18
71707969|NCT01898091|142933946|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxin rank sum test|||Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.||||0.84
71707970|NCT03511209|142933988|SUPERIORITY||Odds Ratio (OR)|2.13|STANDARD_ERROR_OF_MEAN|0.85||0.056|TWO_SIDED|95.0|0.98|4.64|||Regression, Logistic|||Compared CBTI plus Taper method A to CBTI plus Taper method B||4.64|0.98|0.056
71707971|NCT03511209|142933989|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.27||0.405|TWO_SIDED|95.0|-3.57|1.44|||Mixed Models Analysis|Interaction contrast of Treatment Group (CBTI plus Taper method A vs. CBTI plus Taper method B) by Time (6 Months vs. Baseline)||||1.44|-3.57|0.405
71765073|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|30.2|||<|0.001|TWO_SIDED|95.0|19.95|40.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.47|19.95|<0.001
71707972|NCT03782103|142934015|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|-0.2845|||||TWO_SIDED|95.0|-0.6033|0.0334||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.0334|-0.6033|
71707973|NCT03782103|142934015|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|2.8535|||||TWO_SIDED|95.0|2.5415|3.1655||||||Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||3.1655|2.5415|
71707974|NCT03782103|142934016|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|0.0577|||||TWO_SIDED|95.0|-0.1457|0.2611||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.2611|-0.1457|
71765074|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||35.81|16.78|<0.001
71707975|NCT03782103|142934016|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.8208|||||TWO_SIDED|95.0|1.6153|2.0264||||||Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.0264|1.6153|
71707976|NCT00452400|142934051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.027||0.0233||95.0|0.008|0.113|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.113|0.008|0.0233
71707977|NCT00452400|142934051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.027||0.0003||95.0|0.044|0.149|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.149|0.044|0.0003
71707978|NCT00452400|142934051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.072|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.072|<0.0001
71707979|NCT00452400|142934051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.08|0.185|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.185|0.080|<0.0001
71765075|NCT01578850|143032725|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.67|37.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||37.47|16.67|<0.001
71765076|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|1.3||||0.774|TWO_SIDED|95.0|-9.03|11.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 24||11.68|-9.03|0.774
71765077|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.034|TWO_SIDED|95.0|2.86|21.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||21.69|2.86|0.034
71765078|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|16.9||||0.02|TWO_SIDED|95.0|6.33|27.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||27.54|6.33|0.020
71707980|NCT00452400|142934052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0004||95.0|0.039|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|0.039|0.0004
71707981|NCT00452400|142934052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.088|0.186|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.186|0.088|<0.0001
71707982|NCT00452400|142934052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.176|0.080|<0.0001
71707983|NCT00452400|142934052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.218|0.120|<0.0001
71707984|NCT00452400|142934053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.026||0.0011||95.0|0.034|0.136|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.136|0.034|0.0011
71707985|NCT00452400|142934053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.07|0.173|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.173|0.070|<0.0001
71707986|NCT00452400|142934053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.075|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.175|0.075|<0.0001
71707987|NCT00452400|142934053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.179|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.179|0.077|<0.0001
71707988|NCT00452400|142934054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0127||95.0|0.024|0.197|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.197|0.024|0.0127
71707989|NCT00452400|142934054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001||95.0|0.087|0.261|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.261|0.087|<0.0001
71707990|NCT00452400|142934054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.043||0.0001||95.0|0.084|0.255|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.255|0.084|0.0001
71707991|NCT00452400|142934054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.084|0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.258|0.084|0.0001
71707992|NCT00452400|142934055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.0836||95.0|-0.012|0.192|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.192|-0.012|0.0836
71707993|NCT00452400|142934055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.052||0.0011||95.0|0.068|0.274|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.274|0.068|0.0011
71707994|NCT00452400|142934055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.051||0.0037||95.0|0.049|0.25|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.250|0.049|0.0037
71707995|NCT00452400|142934055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.052||0.0047||95.0|0.046|0.251|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.251|0.046|0.0047
71707996|NCT00452400|142934056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.051||0.0695||95.0|-0.008|0.195|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.195|-0.008|0.0695
71707997|NCT00452400|142934056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.052||0.0018||95.0|0.061|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.264|0.061|0.0018
71707998|NCT00452400|142934056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.051||0.0008||95.0|0.072|0.272|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.272|0.072|0.0008
71707999|NCT00452400|142934056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.052||0.0006||95.0|0.077|0.281|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.281|0.077|0.0006
71708000|NCT00452400|142934057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.078|0.204|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.204|0.078|<0.0001
71708001|NCT00452400|142934057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.099|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.225|0.099|<0.0001
71708002|NCT00452400|142934057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.151|0.275|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.275|0.151|<0.0001
71708003|NCT00452400|142934057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.151|0.277|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.277|0.151|<0.0001
71708004|NCT00452400|142934058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.097|0.231|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.231|0.097|<0.0001
71708005|NCT00452400|142934058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.102|0.237|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.237|0.102|<0.0001
71708006|NCT00452400|142934058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.152|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.152|<0.0001
71708007|NCT00452400|142934058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.157|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.292|0.157|<0.0001
71708008|NCT00452400|142934059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.15|0.373|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.373|0.150|<0.0001
71708009|NCT00452400|142934059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.171|0.395|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.395|0.171|<0.0001
71708010|NCT00452400|142934059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.311|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.201|0.421|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.421|0.201|<0.0001
71708011|NCT00452400|142934059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001||95.0|0.192|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.416|0.192|<0.0001
71708012|NCT00452400|142934060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.167|0.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.409|0.167|<0.0001
71708013|NCT00452400|142934060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.159|0.401|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.401|0.159|<0.0001
71708014|NCT00452400|142934060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.178|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.416|0.178|<0.0001
71708015|NCT00452400|142934060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|0.164|0.407|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.407|0.164|<0.0001
71708016|NCT00452400|142934061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.09|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.176|0.090|<0.0001
71708017|NCT00452400|142934061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.128|0.215|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.215|0.128|<0.0001
71708018|NCT00452400|142934061|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.162|0.247|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.247|0.162|<0.0001
71708019|NCT00452400|142934061|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.159|0.246|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.246|0.159|<0.0001
71708020|NCT00452400|142934062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.131|0.243|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.243|0.131|<0.0001
71708021|NCT00452400|142934062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.159|0.271|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.271|0.159|<0.0001
71708022|NCT00452400|142934062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.163|0.273|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.273|0.163|<0.0001
71708023|NCT00452400|142934062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.191|0.304|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.304|0.191|<0.0001
71708024|NCT00452400|142934063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.1|0.219|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.219|0.100|<0.0001
71708025|NCT00452400|142934063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.134|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.253|0.134|<0.0001
71708026|NCT00452400|142934063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.262|0.144|<0.0001
71708027|NCT00452400|142934063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.145|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.264|0.145|<0.0001
71708028|NCT00452400|142934064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.101|0.209|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.209|0.101|<0.0001
71708029|NCT00452400|142934064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.131|0.239|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.239|0.131|<0.0001
71708030|NCT00452400|142934064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.178|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.284|0.178|<0.0001
71708031|NCT00452400|142934064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.177|0.286|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.286|0.177|<0.0001
71708032|NCT00452400|142934065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.264|0.140|<0.0001
71708033|NCT00452400|142934065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.169|0.294|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.294|0.169|<0.0001
71708034|NCT00452400|142934065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.172|0.295|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.295|0.172|<0.0001
71708035|NCT00452400|142934065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.197|0.322|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.322|0.197|<0.0001
71708036|NCT00452400|142934066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.101|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.228|0.101|<0.0001
71708037|NCT00452400|142934066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.125|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.125|<0.0001
71708038|NCT00452400|142934066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.14|0.266|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.266|0.140|<0.0001
71708039|NCT00452400|142934066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.137|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.265|0.137|<0.0001
71708040|NCT00452400|142934067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.039||0.2392||95.0|-0.03|0.121|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.121|-0.030|0.2392
71708041|NCT00452400|142934067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.038||0.0001||95.0|0.072|0.222|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.222|0.072|0.0001
71708042|NCT00452400|142934067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.099|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.253|0.099|<0.0001
71708043|NCT00452400|142934067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.039||0.0001||95.0|0.076|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.228|0.076|0.0001
71708044|NCT00452400|142934068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.0309||95.0|0.008|0.162|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.162|0.008|0.0309
71708045|NCT00452400|142934068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.098|0.25|||ANCOVA||Olo 2 mcg qd minus Placebo|||0.250|0.098|<0.0001
71708046|NCT00452400|142934068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|0.072|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.228|0.072|0.0002
71708047|NCT00452400|142934068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.039||0.0006||95.0|0.059|0.214|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.214|0.059|0.0006
71708048|NCT00452400|142934069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.215||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2150
71708049|NCT00452400|142934069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
71708050|NCT00452400|142934069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.043||0.023||95.0|0.014|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.184|0.014|0.0230
71708051|NCT00452400|142934069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.043||0.0333||95.0|0.007|0.177|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.177|0.007|0.0333
71708052|NCT00452400|142934070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.043||0.2158||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.137|-0.031|0.2158
71708053|NCT00452400|142934070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.212|0.046|0.0024
71708054|NCT00452400|142934070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.043||0.0013||95.0|0.055|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.225|0.055|0.0013
71708055|NCT00452400|142934070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.043||0.0376||95.0|0.005|0.174|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.174|0.005|0.0376
71708056|NCT00452400|142934071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.705|STANDARD_ERROR_OF_MEAN|5.916||0.0211|TWO_SIDED|95.0|2.07|25.34|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||25.340|2.070|0.0211
71708057|NCT00452400|142934071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.285|STANDARD_ERROR_OF_MEAN|5.951||0.0004|TWO_SIDED|95.0|9.581|32.99|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||32.990|9.581|0.0004
71708058|NCT00452400|142934071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.077|STANDARD_ERROR_OF_MEAN|5.832|<|0.0001|TWO_SIDED|95.0|26.607|49.546|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||49.546|26.607|<.0001
71708059|NCT00452400|142934071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.063|STANDARD_ERROR_OF_MEAN|5.99||0.0001|TWO_SIDED|95.0|11.282|34.845|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||34.845|11.282|0.0001
71708060|NCT00452400|142934072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.446|STANDARD_ERROR_OF_MEAN|6.283||0.0973|TWO_SIDED|95.0|-1.911|22.803|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||22.803|-1.911|0.0973
71708061|NCT00452400|142934072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.333|STANDARD_ERROR_OF_MEAN|6.36||0.0005|TWO_SIDED|95.0|9.824|34.842|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||34.842|9.824|0.0005
71708062|NCT00452400|142934072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.232|STANDARD_ERROR_OF_MEAN|6.192|<|0.0001|TWO_SIDED|95.0|26.054|50.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||50.409|26.054|<.0001
71708063|NCT00452400|142934072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.408|STANDARD_ERROR_OF_MEAN|6.403|<|0.0001|TWO_SIDED|95.0|12.814|38.002|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||38.002|12.814|<.0001
71708064|NCT00452400|142934073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.364||0.1541|TWO_SIDED|95.0|-1.237|0.196|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.196|-1.237|0.1541
71708065|NCT00452400|142934073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.367||0.7065|TWO_SIDED|95.0|-0.583|0.859|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.859|-0.583|0.7065
71708066|NCT00452400|142934073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.964|STANDARD_ERROR_OF_MEAN|0.359||0.0076|TWO_SIDED|95.0|-1.671|-0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.258|-1.671|0.0076
71708067|NCT00452400|142934073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|STANDARD_ERROR_OF_MEAN|0.369||0.2626|TWO_SIDED|95.0|-1.138|0.311|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||0.311|-1.138|0.2626
71708068|NCT03378635|142934126|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test. Kaplan-Meier estimate with 95% CI, p-value based on treatment group difference between dasiglucagon and placebo using a two-sided log-rank test stratified by injection site. Treatment groups without censoring utilized a distribution free method to compute the confidence interval for median time.||||<0.001
71708069|NCT03378635|142934127|SUPERIORITY||||||<|0.001||||||p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|Fisher Exact|||Pairwise test of independent binomial proportions with Fisher's Exact test comparing dasiglucagon versus placebo. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.001
71826418|NCT01120275|143157413|SUPERIORITY_OR_OTHER||6-month PFS|0.09|||||TWO_SIDED|95.0|0.02|0.22||||||6-month progression free survival (PFS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.22|0.02|
71708070|NCT03378635|142934128|SUPERIORITY||||||<|0.001||||||The p-value was \<0.001 at all time points (10, 15, 20 and 30 minutes)|ANCOVA|||Plasma glucose (PG) change from baseline at rescue was carried forward in patients who required rescue intravenous (IV) glucose before reaching PG recovery. Change from baseline was analyzed using an ANCOVA, with treatment group as fixed effect and baseline PG as covariate. Group difference was evaluated inferentially following an a priori defined hierarchical test order, proceeding until the first failure to reject the null hypothesis.||||<0.001
71826419|NCT01120275|143157414|SUPERIORITY_OR_OTHER||1-year OS|0.5|||||TWO_SIDED|95.0|0.32|0.66||||||1-year overall survival (OS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.||0.66|0.32|
71886590|NCT01340209|143293512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.054||0.127|TWO_SIDED|95.0|-0.023|0.188|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||0.188|-0.023|0.1270
71708071|NCT03378635|142934129|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated using a Kaplan-Meier estimate with 95% confidence interval, p-value based on a pairwise two-sided log-rank test versus placebo.||||<0.001
71708072|NCT03378635|142934130|SUPERIORITY||Mean Difference (Net)|0.131|||<|0.001|TWO_SIDED|95.0|0.1|0.171|||ANCOVA|||The log-transformed AUC endpoint was analyzed using an analysis of covariance model with treatment as fixed effect and baseline plasma glucose modeled as a covariate. The least squares means treatment group differences were back-transformed (anti-logged) for presentation as a ratio of the treatment group geometric means, with their corresponding 95% confidence interval.||0.171|0.1|<0.001
71708073|NCT03378635|142934131|SUPERIORITY||Mean Difference (Net)|0.91||||0.144|TWO_SIDED|95.0|0.801|1.033|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||1.033|0.801|0.144
71708074|NCT03378635|142934132|SUPERIORITY||Mean Difference (Net)|0.844||||0.006|TWO_SIDED|95.0|0.749|0.951|||ANCOVA|||Least square mean ratio for GlucaGen: dasiglucagon||0.951|0.749|0.006
71708075|NCT00562861|142934148|SUPERIORITY_OR_OTHER||F value|1.88||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
71886591|NCT01340209|143293513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.498|STANDARD_ERROR_OF_MEAN|12.282||0.9677|TWO_SIDED|95.0|-23.634|24.63|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||24.630|-23.634|0.9677
71886592|NCT01340209|143293513|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|34.176|STANDARD_ERROR_OF_MEAN|12.346||0.0058|TWO_SIDED|95.0|9.919|58.432|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium Respimat 5 μg minus placebo||58.432|9.919|0.0058
71708076|NCT01694771|142934149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.144|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.144|0.090|<0.0001
71708077|NCT01694771|142934150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.088|0.037|<0.0001
71708078|NCT01694771|142934151|SUPERIORITY_OR_OTHER||Mean change from baseline|0.119|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.147|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.147|0.090|<0.0001
71708079|NCT01694771|142934152|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.146|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.1|0.192|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.192|0.100|<0.0001
71708080|NCT01694771|142934153|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.063|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.019|0.106|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).||0.106|0.019|0.0047
71708081|NCT01694771|142934154|SUPERIORITY_OR_OTHER||Mean difference from Tio + Placebo|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.106|0.201|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).||0.201|0.106|<0.0001
71886593|NCT01340209|143293514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.646|STANDARD_ERROR_OF_MEAN|9.182||0.3468|TWO_SIDED|95.0|-9.388|26.68|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||26.680|-9.388|0.3468
71886594|NCT01340209|143293514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.216|STANDARD_ERROR_OF_MEAN|9.238||0.5013||95.0|-11.927|24.359|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||24.359|-11.927|0.5013
71708082|NCT01694771|142934155|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|8.459|STANDARD_ERROR_OF_MEAN|2.192||0.0001|TWO_SIDED|95.0|4.159|12.759|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||12.759|4.159|0.0001
71708083|NCT01694771|142934156|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.478|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.706|-0.25|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.250|-0.706|<.0001
71886595|NCT01340209|143293515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.458|STANDARD_ERROR_OF_MEAN|9.196||0.2132|TWO_SIDED|95.0|-6.601|29.517|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||29.517|-6.601|0.2132
71655006|NCT03265288|142827854|SUPERIORITY||Least Squares Means difference|-2.89||||0.0822|TWO_SIDED|95.0|-6.154|0.374||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Intent-to-Treat population (ITT), null hypothesis is no treatment effect||0.374|-6.154|0.0822
71655007|NCT03265288|142827854|SUPERIORITY||Least Squares Means difference|-576.0||||0.0603|TWO_SIDED|95.0|-1177.0|25.4||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Intent-to-Treat population (ITT), null hypothesis is no treatment effect||25.4|-1177|0.0603
71655008|NCT03265288|142827854|SUPERIORITY||Least Square Means difference|-3.853||||0.0287|TWO_SIDED|95.0|-7.297|-0.408||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|C-Reactive Protein (CRP), Per-Protocol population (PP), null hypothesis is no treatment effect||-0.408|-7.297|0.0287
71655009|NCT03265288|142827854|SUPERIORITY||Least Square Means difference|-620.0||||0.0459|TWO_SIDED|95.0|-1228.0|12.0||alpha is set to 0.05|Mixed Model for Repeated Measures||A negative difference favours LAU-7b, a positive difference favours placebo|Calprotectin, Per-Protocol population (PP), null hypothesis is no treatment effect||12|-1228|0.0459
71655010|NCT03265288|142827855|SUPERIORITY||Least Squares Means difference|-0.39||||0.1006|TWO_SIDED|95.0|-0.86|0.08||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body weight, Intent to treat population (ITT), null hypothesis is no treatment effect||0.08|-0.86|0.1006
71655011|NCT03265288|142827856|SUPERIORITY||Least Squares Means difference|-0.137||||0.1246|TWO_SIDED|95.0|-0.312|0.038||alpha is set to 0.05|Mixed Model for Repeated Measures|||Body mass index, intent to treat population (ITT), null hypothesis is no treatment effect||0.038|-0.312|0.1246
71655012|NCT03265288|142827857|SUPERIORITY|||||||0.764||||||alpha is set to 0.05|ANOVA|||Intent to treat population (ITT), null hypothesis is no treatment effect||||0.7640
71655013|NCT03265288|142827858|SUPERIORITY||Least Squares Means difference|-2.758||||0.2996|TWO_SIDED|95.0|-7.998|2.482||alpha is set to 0.05|Mixed Model for Repeated Measures|||CFQ-R Respiratory subscore, intent to treat population (ITT), null hypothesis is no treatment effect||2.482|-7.998|0.2996
71655014|NCT03197558|142827863|SUPERIORITY|Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.|Bootstrap method|14.35|||||ONE_SIDED|97.5||14.35||||||Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.||14.35||
71655015|NCT01939496|142827930|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-3.29|STANDARD_ERROR_OF_MEAN|1.748||0.062|TWO_SIDED|95.0|-6.743|0.163|||ANCOVA|||||0.163|-6.743|0.062
71655016|NCT01939496|142827930|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-4.93|STANDARD_ERROR_OF_MEAN|1.75||0.006|TWO_SIDED|95.0|-8.382|-1.469|||ANCOVA|||||-1.469|-8.382|0.006
71655017|NCT02278718|142827986|SUPERIORITY|||||||0.0008|||||||Generalized Wilcoxon-Gehan Test|||Wilcoxon test statistic was estimated using generalized Wilcoxon-Gehan test stratified by center group, age group, % TBSA group, proportion of FT area group and number of TWs group. A negative (positive) statistic is associated with longer (shorter) time to the event when treated with NexoBrid vs. Standard of Care. P-value was calculated using the re-randomization test.||||0.0008
71655018|NCT02278718|142827987|SUPERIORITY||Odds Ratio (OR)|0.025|||<|0.0001|TWO_SIDED|95.0|0.007|0.09|||Fisher Exact|||Incidence of Surgical Excision for Eschar Removal for NexoBrid vs SOC||0.090|0.007|<0.0001
71655019|NCT02278718|142827988|SUPERIORITY|||||||0.1374|||||||t-test, 2 sided|||||||0.1374
71655020|NCT02278718|142827989|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.5045|TWO_SIDED||||||t-test, 2 sided|||||||0.5045
71655021|NCT02278718|142827990|SUPERIORITY||Odds Ratio (OR)|0.414||||0.0545|TWO_SIDED|95.0|0.163|1.054|||t-test, 2 sided|||||1.054|0.163|0.0545
71655022|NCT04440449|142827999|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71655023|NCT04440449|142828000|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|||||||0.108
71655024|NCT03212794|142828004|SUPERIORITY||||||=|0.87||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.87
71655025|NCT03212794|142828005|SUPERIORITY||||||=|0.82||||||Threshold for significance p\<0.05|Chi-squared|||||||=0.82
71655026|NCT03212794|142828006|OTHER||||||=|0.92||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.92
71655027|NCT03212794|142828007|OTHER||||||=|0.85||||||Threshold for significance p\<0.05|Log Rank|If no event occurred, the data from those individuals were right censored.||||||=0.85
71655028|NCT01763918|142828008|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.23|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-65.11|-53.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.35|-65.11|<0.001
71708084|NCT01694771|142934157|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.083|STANDARD_ERROR_OF_MEAN|0.041||0.0442|TWO_SIDED|95.0|-0.164|-0.002|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.002|-0.164|0.0442
71708085|NCT01694771|142934158|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.393|STANDARD_ERROR_OF_MEAN|0.098|<|0.0001|TWO_SIDED|95.0|-0.586|-0.2|||ANCOVA|||"Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."||-0.200|-0.586|<.0001
71708086|NCT00289900|142934165|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.2|||<|0.001|TWO_SIDED|95.0|-16.8|-9.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.6|-16.8|<0.001
71708087|NCT00289900|142934165|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.8|-7.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-7.8|-13.8|<0.001
71708088|NCT00289900|142934165|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.1|||<|0.001|TWO_SIDED|95.0|-8.1|-2.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.1|-8.1|<0.001
71708089|NCT00289900|142934165|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.2||||0.007|TWO_SIDED|95.0|-7.2|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-7.2|0.007
71708090|NCT00289900|142934166|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|19.9|||<|0.001|TWO_SIDED|95.0|17.2|22.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||22.6|17.2|<0.001
71708091|NCT00289900|142934166|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|21.3|||<|0.001|TWO_SIDED|95.0|19.0|23.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||23.6|19.0|<0.001
71708092|NCT00289900|142934166|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|22.1|||<|0.001|TWO_SIDED|95.0|19.8|24.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||24.4|19.8|<0.001
71708093|NCT00289900|142934166|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|23.0|||<|0.001|TWO_SIDED|95.0|20.7|25.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||25.3|20.7|<0.001
71708094|NCT00289900|142934167|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-17.3|||<|0.001|TWO_SIDED|95.0|-21.2|-13.3|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test|||-13.3|-21.2|<0.001
71708095|NCT00289900|142934167|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-19.1|-11.9|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-11.9|-19.1|<0.001
71708096|NCT00289900|142934167|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-7.0|-13.7|<0.001
71708097|NCT00289900|142934167|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-3.4|-10.2|<0.001
71708098|NCT00289900|142934168|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|||<|0.001|TWO_SIDED|95.0|-12.1|-6.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.0|-12.1|<0.001
71708099|NCT00289900|142934168|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.4|||<|0.001|TWO_SIDED|95.0|-8.0|-2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.9|-8.0|<0.001
71708100|NCT00289900|142934168|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.4||||0.771|TWO_SIDED|95.0|-2.2|2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.9|-2.2|0.771
71708101|NCT00289900|142934168|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.4||||0.065|TWO_SIDED|95.0|-0.2|5.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.0|-0.2|0.065
71708102|NCT00289900|142934169|SUPERIORITY_OR_OTHER||Difference in least Squares Mean|-6.8|||<|0.001|TWO_SIDED|95.0|-10.2|-3.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.5|-10.2|<0.001
71708103|NCT00289900|142934169|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.0||||0.037|TWO_SIDED|95.0|-5.8|-0.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-0.2|-5.8|0.037
71708104|NCT00289900|142934169|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|2.8||||0.047|TWO_SIDED|95.0|0.0|5.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||5.6|0.0|0.047
71765079|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|14.6||||0.007|TWO_SIDED|95.0|5.48|23.8|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||23.80|5.48|0.007
71708105|NCT00289900|142934169|SUPERIORITY_OR_OTHER||Difference in Least Sqaures Mean|4.7|||<|0.001|TWO_SIDED|95.0|2.0|7.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||7.5|2.0|<0.001
71708106|NCT00289900|142934170|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.2|||<|0.001|TWO_SIDED|95.0|-12.1|-6.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-6.3|-12.1|<0.001
71708107|NCT00289900|142934170|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.2|||<|0.001|TWO_SIDED|95.0|-7.7|-2.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-2.8|-7.7|<0.001
71708108|NCT00289900|142934170|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9||||0.476|TWO_SIDED|95.0|-3.3|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-3.3|0.476
71708109|NCT00289900|142934170|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|0.2||||0.845|TWO_SIDED|95.0|-2.2|2.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||2.7|-2.2|0.845
71708110|NCT00289900|142934171|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|6.6|11.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||11.4|6.6|<0.001
71708111|NCT00289900|142934171|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|7.7|||<|0.001|TWO_SIDED|95.0|5.8|9.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||9.7|5.8|<0.001
71708112|NCT00289900|142934171|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|9.0|||<|0.001|TWO_SIDED|95.0|7.0|10.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||10.9|7.0|<0.001
71708113|NCT00289900|142934171|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|10.7|||<|0.001|TWO_SIDED|95.0|8.7|12.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||12.7|8.7|<0.001
71708114|NCT00289900|142934172|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.6||||0.003|TWO_SIDED|95.0|-6.0|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-1.2|-6.0|0.003
71708115|NCT00289900|142934172|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.5||||0.595|TWO_SIDED|95.0|-2.5|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||1.5|-2.5|0.595
71708116|NCT00289900|142934172|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||6.2|2.2|<0.001
71708117|NCT00289900|142934172|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|6.1|||<|0.001|TWO_SIDED|95.0|4.1|8.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||8.1|4.1|<0.001
71708118|NCT00289900|142934173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-18.8|||<|0.001|TWO_SIDED|95.0|-24.2|-14.2|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-14.2|-24.2|<0.001
71708119|NCT00289900|142934173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-25.0|-16.6|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-16.6|-25.0|<0.001
71708120|NCT00289900|142934173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.9|||<|0.001|TWO_SIDED|95.0|-27.8|-19.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-19.4|-27.8|<0.001
71708121|NCT00289900|142934173|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-24.6|||<|0.001|TWO_SIDED|95.0|-28.6|-20.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||-20.0|-28.6|<0.001
71708122|NCT00289900|142934174|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.5|TWO_SIDED|95.0|-9.6|7.5|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||7.5|-9.6|0.500
71765080|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|24.9|||<|0.001|TWO_SIDED|95.0|14.72|34.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||34.98|14.72|<0.001
71765081|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|18.8|||<|0.001|TWO_SIDED|95.0|10.16|27.38|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||27.38|10.16|<0.001
71826420|NCT02595398|143157420|SUPERIORITY||Difference in percentages|31.25|||<|0.001|TWO_SIDED|95.0|15.5|45.9||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between country strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the country, i.e., US+Israel and India.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|A total sample size of 150 subjects in a 3:2 randomization had 90% power to detect a difference between treatments in the proportion of subjects showing improvement is 0.60 for treated and 0.34 for sham. The primary analysis was a test of superiority of the CLS-TA arm over the sham arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by country.||45.9|15.5|<0.001
71765082|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|30.9|||<|0.001|TWO_SIDED|95.0|21.03|40.76|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||40.76|21.03|<0.001
71765083|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|20.6|||<|0.001|TWO_SIDED|95.0|11.78|29.52|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||29.52|11.78|<0.001
71765084|NCT01578850|143032727|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|17.38|36.93|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||36.93|17.38|<0.001
71765085|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.2|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 28||-0.20|-0.73|<0.001
71765086|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.006|TWO_SIDED|95.0|-0.61|-0.11|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 28||-0.11|-0.61|0.006
71765087|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 36||-0.39|-0.96|<0.001
71765088|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 36||-0.28|-0.82|<0.001
71826421|NCT00434018|143157459|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
71826422|NCT00414648|143157469|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The model included the time since enrollment, the treatment assignment, and the interaction between time and treatment.|Regression, Linear|Mixed model with the use of the Kenward-Roger correction without imputation of missing data.||FEV1 slope||||<0.001
71765089|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.03|-0.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 44||-0.46|-1.03|<0.001
71765090|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.92|-0.37|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 44||-0.37|-0.92|<0.001
71765091|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.98|-0.4|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-ESR Week 52||-0.40|-0.98|<0.001
71765092|NCT01578850|143032729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.91|-0.36|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||DAS28-CRP Week 52||-0.36|-0.91|<0.001
71765093|NCT01578850|143032730|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
71765094|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|1.4||||0.961|TWO_SIDED|95.0|-6.13|8.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 24||8.90|-6.13|0.961
71765095|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|21.5||||0.001|TWO_SIDED|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 28||32.02|10.99|0.001
71765096|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.007|TWO_SIDED|95.0|8.08|28.53|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 28||28.53|8.08|0.007
71765097|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|31.4|||<|0.001|TWO_SIDED|95.0|21.42|41.39|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 36||41.39|21.42|<0.001
71826423|NCT00414648|143157470|OTHER|||||||0.441|||||||Chi-squared|||||||.441
71826424|NCT00414648|143157471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
71826425|NCT00414648|143157472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|GLM adjusted for baseline||||||0.17
71708123|NCT00289900|142934174|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.9||||0.083|TWO_SIDED|95.0|0.0|13.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||13.8|0.0|0.083
71708124|NCT00289900|142934174|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.9||||0.005|TWO_SIDED|95.0|5.2|18.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||18.8|5.2|0.005
71708125|NCT00289900|142934174|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.4|||<|0.001|TWO_SIDED|95.0|9.8|22.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test|||22.8|9.8|<0.001
71708126|NCT00289900|142934175|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.8|||<|0.001|TWO_SIDED|95.0|-15.6|-9.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-9.9|-15.6|<0.001
71708127|NCT00289900|142934175|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.8|||<|0.001|TWO_SIDED|95.0|-13.2|-8.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-8.4|-13.2|<0.001
71708128|NCT00289900|142934175|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.4||||0.001|TWO_SIDED|95.0|-8.8|-4.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-4.0|-8.8|0.001
71708129|NCT00289900|142934175|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.6|||<|0.001|TWO_SIDED|95.0|-8.0|-3.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate||||-3.2|-8.0|<0.001
71708130|NCT00289900|142934176|SUPERIORITY_OR_OTHER||Difference in Proportion|-1.4||||0.008|TWO_SIDED|95.0|-2.3|-0.5|||Miettinen and Nurminen|||||-0.5|-2.3|0.008
71826426|NCT00414648|143157473|SUPERIORITY|||||||0.34|||||||Regression, Linear|GLM adjusted for baseline||||||0.34
71826427|NCT00414648|143157474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Regression, Linear|GLM adjusted for baseline||||||0.88
71708131|NCT00289900|142934177|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.7||||0.042|TWO_SIDED|95.0|-1.4|0.0|||Miettinen and Nurminen|||||-0.0|-1.4|0.042
71708132|NCT00289900|142934178|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.1||||0.346|TWO_SIDED|95.0|-0.5|0.4|||Miettinen and Nurminen|||||0.4|-0.5|0.346
71765098|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.83|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 36||37.54|16.83|<0.001
71826428|NCT00414648|143157475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Linear|GLM adjusted for baseline||||||0.001
71708133|NCT00289900|142934179|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.556|TWO_SIDED|95.0|-0.2|0.7|||Miettinen and Nurminen|||||0.7|-0.2|0.556
71708134|NCT00289900|142934180|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134|TWO_SIDED|95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
71708135|NCT00289900|142934181|SUPERIORITY_OR_OTHER||Difference in Proportion|0.1||||0.134||95.0|-0.1|0.8|||Miettinen and Nurminen|||||0.8|-0.1|0.134
71708136|NCT00289900|142934182|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1||||0.5625|TWO_SIDED|95.0|-0.3|0.9|||Miettinen and Nurminen|||||0.9|-0.3|0.5625
71826429|NCT04173572|143157476|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-13.47|STANDARD_DEVIATION|48.09|||TWO_SIDED|||||||||Posttreatment - Baseline: 10 participants analyzed (had data at both time points)||||
71708137|NCT00289900|142934183|SUPERIORITY_OR_OTHER||Difference in Percentage|0.7||||0.0233|TWO_SIDED|95.0|0.1|1.7|||Miettinen and Nurminen|||||1.7|0.1|0.0233
71708138|NCT00289900|142934184|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.7858|TWO_SIDED|95.0|-0.4|0.6|||Miettinen and Nurminen|||||0.6|-0.4|0.7858
71708139|NCT00289900|142934185|SUPERIORITY_OR_OTHER||Difference in Percentage|13.7|||||TWO_SIDED|95.0|9.4|18.0|||Miettinen and Nurminen|||||18.0|9.4|
71708140|NCT00289900|142934186|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.7|||||TWO_SIDED|95.0|-2.6|1.4|||Miettinen and Nurminen|||||1.4|-2.6|
71708141|NCT00289900|142934187|SUPERIORITY_OR_OTHER||Difference in Percentage|11.7|||||TWO_SIDED|95.0|8.9|14.7|||Miettinen and Nurminen|||||14.7|8.9|
71708142|NCT00289900|142934188|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-0.8|0.9|||Miettinen and Nurminen|||||0.9|-0.8|
71708143|NCT00289900|142934189|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.1||||0.4997|TWO_SIDED|95.0|-0.4|0.5|||Miettinen and Nurminen|||||0.5|-0.4|0.4997
71826430|NCT04173572|143157476|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.7|STANDARD_DEVIATION|52.743|||TWO_SIDED|||||||||Posttreatment - Baseline: 9 participants analyzed (had data at both time points)||||
71826431|NCT04173572|143157477|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|22.133|STANDARD_DEVIATION|79.938|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71765099|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|31.3|||<|0.001|TWO_SIDED|95.0|21.53|41.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 44||41.02|21.53|<0.001
71708144|NCT02656173|142934198|SUPERIORITY||least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.82|-0.21|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis, including treatment group and region as fixed factors and baseline as a covariate.||-0.21|-0.82|<0.001
71708145|NCT02656173|142934199|SUPERIORITY||least square mean difference|-0.48|||<|0.001|TWO_SIDED|95.0|-0.78|-0.17|||mixed model repeated measure|||Mixed Model Repeated Measure (MMRM) was used for analysis, which included the baseline as a covariate, treatment group, analysis visits and region as a fixed effect, subject as random effect and including interaction of \[treatment group x visit\] for FAS.||-0.17|-0.78|<0.001
71708146|NCT02656173|142934200|SUPERIORITY||least square mean difference|-0.28||||0.112|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.07|-0.63|0.112
71708147|NCT02656173|142934201|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|1.75||||0.186|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.186
71708148|NCT02656173|142934202|SUPERIORITY||Cochran-Mantel-Haenszel Statistics|0.09||||0.76|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.||||0.760
71708149|NCT02656173|142934203|SUPERIORITY||Least square mean difference|-0.03||||0.646|TWO_SIDED|95.0|-0.18|0.11|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.11|-0.18|0.646
71708150|NCT02656173|142934204|SUPERIORITY||Least square mean difference|12.08|||<|0.001|TWO_SIDED|95.0|6.33|17.84|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||17.84|6.33|<0.001
71708151|NCT02656173|142934205|SUPERIORITY||Least square mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.26|-1.04|0.001
71765100|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|30.8|||<|0.001|TWO_SIDED|95.0|20.54|41.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 44||41.05|20.54|<0.001
71765101|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|26.3|||<|0.001|TWO_SIDED|95.0|16.82|35.74|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 52||35.74|16.82|<0.001
71708152|NCT02656173|142934206|SUPERIORITY||Least square mean difference|-0.11||||0.006|TWO_SIDED|95.0|-0.19|-0.03|||ANCOVA|||Subscale: Daytime Frequency. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.03|-0.19|0.006
71765102|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|27.0|||<|0.001|TWO_SIDED|95.0|16.63|37.44|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-CRP Week 52||37.44|16.63|<0.001
71708153|NCT02656173|142934206|SUPERIORITY||Least square mean difference|-0.08||||0.174|TWO_SIDED|95.0|-0.19|0.03|||ANCOVA|||Subscale: Nighttime Frequency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.03|-0.19|0.174
71708154|NCT02656173|142934206|SUPERIORITY||Least square mean difference|-0.26||||0.037|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Subscale: Urgency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.02|-0.50|0.037
71708155|NCT02656173|142934206|SUPERIORITY||Least square mean difference|-0.18||||0.014|TWO_SIDED|95.0|-0.32|-0.04|||ANCOVA|||Subscale: Urgency Incontinence. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.04|-0.32|0.014
71765103|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0||||0.766|TWO_SIDED|95.0|-1.69|1.65|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Good Response: DAS28-ESR Week 24||1.65|-1.69|0.766
71765104|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in Proportions|8.2||||0.091|TWO_SIDED|95.0|2.32|14.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 28||14.10|2.32|0.091
71708156|NCT02656173|142934207|SUPERIORITY||Least square mean difference|-1.19||||0.002|TWO_SIDED|95.0|-1.94|-0.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.44|-1.94|0.002
71708157|NCT02656173|142934208|SUPERIORITY||Least square mean difference|-0.78|||<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Subscale: Storage Subscale. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.43|-1.13|<0.001
71708158|NCT02656173|142934208|SUPERIORITY||Least square mean difference|-0.3||||0.167|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||Subscale: Voiding Subscale-1. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.13|-0.72|0.167
71708159|NCT02656173|142934208|SUPERIORITY||Least square mean difference|-0.42||||0.103|TWO_SIDED|95.0|-0.93|0.09|||ANCOVA|||Subscale: Voiding Subscale-2. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||0.09|-0.93|0.103
71708160|NCT02656173|142934208|SUPERIORITY||Least square mean difference|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07|||ANCOVA|||Subscale: Quality of Life (QoL) Item. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-0.07|-0.51|0.009
71765105|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.227|TWO_SIDED|95.0|1.28|11.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 28||11.75|1.28|0.227
71708161|NCT02656173|142934209|SUPERIORITY||Least square mean difference|-4.52|||<|0.001|TWO_SIDED|95.0|-6.91|-2.13|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||-2.13|-6.91|<0.001
71708162|NCT02656173|142934210|SUPERIORITY||Least square mean difference|2.79|||<|0.001|TWO_SIDED|95.0|1.13|4.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.||4.44|1.13|<0.001
71708163|NCT01064622|142934214|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.15|TWO_SIDED|95.0|0.55|1.22||Reported p-value is one-sided. p\<0.10 required for statistical significance.|Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.22|0.55|0.15
71708164|NCT01064622|142934215|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.37|TWO_SIDED|95.0|0.64|1.46|||Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|||1.46|0.64|0.37
71708165|NCT01064622|142934216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|TWO_SIDED|||||Two-sided p-value for Cochran-Mantel-Haenszel test stratified by Karnofsky performance status and disease status.|Cochran-Mantel-Haenszel|||||||0.42
71708166|NCT02037984|142934237|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
71708167|NCT02037984|142934237|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.22|||||TWO_SIDED|95.0|1.64|3.02||||||||3.02|1.64|
71708168|NCT02037984|142934237|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.37|||||TWO_SIDED|95.0|1.01|1.84||||||||1.84|1.01|
71765106|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|9.9||||0.072|TWO_SIDED|95.0|3.27|16.6|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 36||16.60|3.27|0.072
71765107|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|8.8||||0.108|TWO_SIDED|95.0|2.43|15.2|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 36||15.20|2.43|0.108
71765108|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|11.7||||0.035|TWO_SIDED|95.0|4.69|18.72|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||18.72|4.69|0.035
71765109|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|10.6||||0.03|TWO_SIDED|95.0|4.2|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 44||17.06|4.20|0.030
71765110|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|11.1||||0.048|TWO_SIDED|95.0|4.15|18.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-ESR Week 52||18.06|4.15|0.048
71708169|NCT02037984|142934237|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.71|||||TWO_SIDED|95.0|0.48|1.05||||||||1.05|0.48|
71708170|NCT02037984|142934237|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.6|||||TWO_SIDED|95.0|0.32|1.13||||||||1.13|0.32|
71708171|NCT02037984|142934237|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.34|||||TWO_SIDED|95.0|0.16|0.73||||||||0.73|0.16|
71708172|NCT02037984|142934237|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.72|||||TWO_SIDED|95.0|0.51|1.02||||||||1.02|0.51|
71708173|NCT02037984|142934237|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||||1.08|0.51|
71708174|NCT02037984|142934237|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||||0.90|0.39|
71708175|NCT02037984|142934237|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.31||||||||1.31|0.64|
71708176|NCT02037984|142934237|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.61|1.27||||||||1.27|0.61|
71708177|NCT02037984|142934237|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.22|||||TWO_SIDED|95.0|0.83|1.78||||||||1.78|0.83|
71708178|NCT02037984|142934237|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.91|||||TWO_SIDED|95.0|0.57|1.45||||||||1.45|0.57|
71708179|NCT02037984|142934237|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|67.5|||||TWO_SIDED|95.0|45.58|99.97||||||||99.97|45.58|
71708180|NCT02037984|142934237|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|23.9|||||TWO_SIDED|95.0|13.21|43.24||||||||43.24|13.21|
71708181|NCT02037984|142934238|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.52|||||TWO_SIDED|95.0|0.39|0.7||||||||0.70|0.39|
71708182|NCT02037984|142934238|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|1.79|||||TWO_SIDED|95.0|1.33|2.41||||||||2.41|1.33|
71708183|NCT02037984|142934238|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.87|||||TWO_SIDED|95.0|0.65|1.16||||||||1.16|0.65|
71708184|NCT02037984|142934238|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.35|0.74||||||||0.74|0.35|
71708185|NCT02037984|142934238|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.31|||||TWO_SIDED|95.0|0.17|0.58||||||||0.58|0.17|
71708186|NCT02037984|142934238|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.16|||||TWO_SIDED|95.0|0.08|0.34||||||||0.34|0.08|
71708187|NCT02037984|142934238|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.48|||||TWO_SIDED|95.0|0.34|0.67||||||||0.67|0.34|
71708188|NCT02037984|142934238|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.56|||||TWO_SIDED|95.0|0.39|0.82||||||||0.82|0.39|
71708189|NCT02037984|142934238|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||||0.97|0.42|
71655029|NCT01763918|142828008|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.27|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-69.0|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.55|-69.00|<0.001
71655030|NCT01763918|142828009|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.15|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-65.83|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-65.83|<0.001
71655031|NCT01763918|142828009|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.55|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-71.27|-59.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.83|-71.27|<0.001
71655032|NCT01763918|142828010|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-95.2|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-105.1|-85.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-85.2|-105.1|<0.001
71655033|NCT01763918|142828010|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-97.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-107.1|-87.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-87.7|-107.1|<0.001
71655034|NCT01763918|142828011|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-92.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-102.9|-82.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-82.8|-102.9|<0.001
71655035|NCT01763918|142828011|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-91.3|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-103.8|-78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-78.9|-103.8|<0.001
71655036|NCT01763918|142828012|SUPERIORITY_OR_OTHER||Treatment Difference|65.1|||<|0.001|TWO_SIDED|95.0|52.8|73.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||73.4|52.8|<0.001
71655037|NCT01763918|142828012|SUPERIORITY_OR_OTHER||Treatment Difference|78.5|||<|0.001|TWO_SIDED|95.0|66.9|85.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||85.1|66.9|<0.001
71655038|NCT01763918|142828013|SUPERIORITY_OR_OTHER||Treatment Difference|66.3|||<|0.001|TWO_SIDED|95.0|53.7|74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use||||74.6|53.7|<0.001
71655039|NCT01763918|142828013|SUPERIORITY_OR_OTHER||Treatment Difference|60.9|||<|0.001|TWO_SIDED|95.0|47.6|69.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.||||69.8|47.6|<0.001
71655040|NCT01763918|142828014|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.0|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-61.41|-50.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.59|-61.41|<0.001
71826432|NCT04173572|143157477|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|99.645|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71826433|NCT04173572|143157478|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|13.642|STANDARD_DEVIATION|4213.837|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
71826434|NCT04173572|143157478|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-483.4|STANDARD_DEVIATION|2497.312|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71826435|NCT04173572|143157479|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.229|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71708190|NCT02037984|142934238|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
71708191|NCT02037984|142934238|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
71708192|NCT02037984|142934238|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.11|||||TWO_SIDED|95.0|0.77|1.6||||||||1.60|0.77|
71708193|NCT02037984|142934238|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.68|||||TWO_SIDED|95.0|0.43|1.07||||||||1.07|0.43|
71708194|NCT02037984|142934238|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|44.61|||||TWO_SIDED|95.0|30.42|65.43||||||||65.43|30.42|
71708195|NCT02037984|142934238|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.29|||||TWO_SIDED|95.0|8.58|27.26||||||||27.26|8.58|
71708196|NCT02037984|142934239|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.78|||||TWO_SIDED|95.0|0.57|1.07||||||||1.07|0.57|
71708197|NCT02037984|142934239|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.68|||||TWO_SIDED|95.0|1.95|3.68||||||||3.68|1.95|
71708198|NCT02037984|142934239|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.52|||||TWO_SIDED|95.0|1.11|2.07||||||||2.07|1.11|
71708199|NCT02037984|142934239|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.02||||||||1.02|0.46|
71708200|NCT02037984|142934239|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.33|||||TWO_SIDED|95.0|0.17|0.64||||||||0.64|0.17|
71708201|NCT02037984|142934239|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.11|||||TWO_SIDED|95.0|0.05|0.23||||||||0.23|0.05|
71708202|NCT02037984|142934239|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.73|||||TWO_SIDED|95.0|0.51|1.04||||||||1.04|0.51|
71708203|NCT02037984|142934239|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||||1.30|0.59|
71708204|NCT02037984|142934239|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|1.03|||||TWO_SIDED|95.0|0.66|1.6||||||||1.60|0.66|
71708205|NCT02037984|142934239|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.96|||||TWO_SIDED|95.0|0.66|1.39||||||||1.39|0.66|
71708206|NCT02037984|142934239|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.64|1.39||||||||1.39|0.64|
71708207|NCT02037984|142934239|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.24|||||TWO_SIDED|95.0|0.84|1.84||||||||1.84|0.84|
71708208|NCT02037984|142934239|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
71708209|NCT02037984|142934239|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|77.57|||||TWO_SIDED|95.0|51.6|116.6||||||||116.60|51.60|
71708210|NCT02037984|142934239|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.66|||||TWO_SIDED|95.0|8.46|28.98||||||||28.98|8.46|
71708211|NCT02037984|142934240|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.93||||||||0.93|0.50|
71708212|NCT02037984|142934240|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.21|||||TWO_SIDED|95.0|1.62|3.02||||||||3.02|1.62|
71708213|NCT02037984|142934240|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||||1.31|0.71|
71708214|NCT02037984|142934240|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79||||||||0.79|0.36|
71708215|NCT02037984|142934240|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.49|||||TWO_SIDED|95.0|0.26|0.94||||||||0.94|0.26|
71708216|NCT02037984|142934240|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.36|||||TWO_SIDED|95.0|0.17|0.77||||||||0.77|0.17|
71708217|NCT02037984|142934240|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.6|||||TWO_SIDED|95.0|0.42|0.85||||||||0.85|0.42|
71708218|NCT02037984|142934240|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.54|1.16||||||||1.16|0.54|
71708219|NCT02037984|142934240|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.74|||||TWO_SIDED|95.0|0.48|1.14||||||||1.14|0.48|
71708220|NCT02037984|142934240|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.66|||||TWO_SIDED|95.0|0.46|0.95||||||||0.95|0.46|
71708221|NCT02037984|142934240|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.02||||||||1.02|0.48|
71708222|NCT02037984|142934240|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.88|||||TWO_SIDED|95.0|0.6|1.29||||||||1.29|0.60|
71708223|NCT02037984|142934240|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.43|1.12||||||||1.12|0.43|
71708224|NCT02037984|142934240|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|56.08|||||TWO_SIDED|95.0|37.66|83.52||||||||83.52|37.66|
71708225|NCT02037984|142934240|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|25.75|||||TWO_SIDED|95.0|14.18|46.78||||||||46.78|14.18|
71708226|NCT02037984|142934241|OTHER|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09||||||||1.09|0.58|
71708227|NCT02037984|142934241|OTHER|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.55|||||TWO_SIDED|95.0|1.86|3.49||||||||3.49|1.86|
71708228|NCT02037984|142934241|OTHER|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
71708229|NCT02037984|142934241|OTHER|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||TWO_SIDED|95.0|0.34|0.76||||||||0.76|0.34|
71708230|NCT02037984|142934241|OTHER|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.34|||||TWO_SIDED|95.0|0.17|0.65||||||||0.65|0.17|
71708231|NCT02037984|142934241|OTHER|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.18|||||TWO_SIDED|95.0|0.08|0.38||||||||0.38|0.08|
71708232|NCT02037984|142934241|OTHER|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.59|||||TWO_SIDED|95.0|0.41|0.84||||||||0.84|0.41|
71708233|NCT02037984|142934241|OTHER|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.68|||||TWO_SIDED|95.0|0.46|1.01||||||||1.01|0.46|
71708234|NCT02037984|142934241|OTHER|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.79|||||TWO_SIDED|95.0|0.51|1.22||||||||1.22|0.51|
71708235|NCT02037984|142934241|OTHER|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.72|||||TWO_SIDED|95.0|0.5|1.05||||||||1.05|0.50|
71708236|NCT02037984|142934241|OTHER|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.55|||||TWO_SIDED|95.0|0.37|0.8||||||||0.80|0.37|
71655041|NCT01763918|142828014|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-65.24|-54.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.77|-65.24|<0.001
71655042|NCT01763918|142828015|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.79|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-60.47|-49.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-49.12|-60.47|<0.001
71655043|NCT01763918|142828015|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-61.95|-47.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.96|-61.95|<0.001
71655044|NCT01763918|142828016|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.39|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-54.32|-44.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.46|-54.32|<0.001
71655045|NCT01763918|142828016|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.58|-50.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.38|-59.58|<0.001
71655046|NCT01763918|142828017|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.09|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-54.55|-43.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.63|-54.55|<0.001
71655047|NCT01763918|142828017|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.41|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|-55.73|-43.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-43.10|-55.73|<0.001
71655048|NCT01763918|142828018|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.59|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-51.43|-41.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-41.76|-51.43|<0.001
71655049|NCT01763918|142828018|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.16|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-54.21|-44.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-44.11|-54.21|<0.001
71655050|NCT01763918|142828019|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.08|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-51.27|-40.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.88|-51.27|<0.001
71655051|NCT01763918|142828019|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.42|STANDARD_ERROR_OF_MEAN|3.77|<|0.001|TWO_SIDED|95.0|-52.86|-37.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-37.98|-52.86|<0.001
71655052|NCT01763918|142828020|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.17|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-58.35|-47.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-47.99|-58.35|<0.001
71655053|NCT01763918|142828020|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.56|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-61.08|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-50.05|-61.08|<0.001
71655054|NCT01763918|142828021|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.28|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-60.16|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-48.41|-60.16|<0.001
71655055|NCT01763918|142828021|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-58.14|-40.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-40.96|-58.14|<0.001
71655056|NCT01763918|142828022|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.37|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-38.33|-24.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.41|-38.33|<0.001
71708237|NCT02037984|142934241|OTHER|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.97|||||TWO_SIDED|95.0|0.66|1.44||||||||1.44|0.66|
71826436|NCT04173572|143157479|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.563|STANDARD_DEVIATION|8.695|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
71708238|NCT02037984|142934241|OTHER|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.79|||||TWO_SIDED|95.0|0.49|1.28||||||||1.28|0.49|
71708239|NCT02037984|142934241|OTHER|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|68.64|||||TWO_SIDED|95.0|45.81|102.84||||||||102.84|45.81|
71708240|NCT02037984|142934241|OTHER|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|20.03|||||TWO_SIDED|95.0|10.88|36.88||||||||36.88|10.88|
71708241|NCT02037984|142934245|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.2|||||TWO_SIDED|95.0|-16.3|6.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.5|-16.3|
71708242|NCT02037984|142934245|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.6|||||TWO_SIDED|95.0|-4.1|32.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.5|-4.1|
71708243|NCT02037984|142934245|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.0|||||TWO_SIDED|95.0|-22.8|5.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.7|-22.8|
71708244|NCT02037984|142934245|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708245|NCT02037984|142934245|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708246|NCT02037984|142934245|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708247|NCT02037984|142934245|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708248|NCT02037984|142934245|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708249|NCT02037984|142934245|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71765111|NCT01578850|143032732|SUPERIORITY_OR_OTHER||Difference in proportions|11.2||||0.016|TWO_SIDED|95.0|4.92|17.58|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Moderate Response: DAS28-CRP Week 52||17.58|4.92|0.016
71826437|NCT04173572|143157480|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|-9.333|STANDARD_DEVIATION|14.166|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71655057|NCT01763918|142828022|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-37.91|-24.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-24.09|-37.91|<0.001
71655058|NCT01763918|142828023|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-31.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-39.28|-23.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.87|-39.28|<0.001
71655059|NCT01763918|142828023|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.24|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-35.61|-20.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-20.88|-35.61|<0.001
71655060|NCT01763918|142828024|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-29.48|-15.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.24|-29.48|<0.001
71655061|NCT01763918|142828024|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.74|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-24.43|-9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-9.05|-24.43|<0.001
71655062|NCT01763918|142828025|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.59|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|-27.92|-11.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-11.26|-27.92|<0.001
71655063|NCT01763918|142828025|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.56|STANDARD_ERROR_OF_MEAN|4.97|<|0.001|TWO_SIDED|95.0|-21.38|-1.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-1.74|-21.38|<0.001
71826438|NCT04173572|143157480|OTHER|Single group mean difference between baseline and post-treatment assessments.|Median Difference (Net)|0.625|STANDARD_DEVIATION|9.664|||TWO_SIDED|||||||||Posttreatment - Baseline: 16 participants analyzed (had data at both time points)||||
71708250|NCT02037984|142934245|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708251|NCT02037984|142934245|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708252|NCT02037984|142934245|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708253|NCT02037984|142934245|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.2|
71708254|NCT02037984|142934245|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71708255|NCT02037984|142934245|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.1|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.1|
71708256|NCT02037984|142934246|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-4.2|||||TWO_SIDED|95.0|-20.4|5.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.6|-20.4|
71708257|NCT02037984|142934246|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|11.8|||||TWO_SIDED|95.0|-10.0|30.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||30.6|-10.0|
71708258|NCT02037984|142934246|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-1.6|||||TWO_SIDED|95.0|-18.8|10.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||10.3|-18.8|
71708259|NCT02037984|142934246|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71826439|NCT04173572|143157481|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.392|STANDARD_DEVIATION|1.148|||TWO_SIDED|||||||||Posttreatment - Baseline: 13 participants analyzed (had data at both time points)||||
71708260|NCT02037984|142934246|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
71826440|NCT04173572|143157481|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.113|STANDARD_DEVIATION|1.401|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71826441|NCT04173572|143157482|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.2|STANDARD_DEVIATION|20.11|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71708261|NCT02037984|142934246|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
71708262|NCT02037984|142934246|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71708263|NCT02037984|142934246|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71708264|NCT02037984|142934246|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71765112|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA Baseline||1.81|-0.59|0.358
71826442|NCT04173572|143157482|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.49|STANDARD_DEVIATION|8.91|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71708265|NCT02037984|142934246|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.5|
71708266|NCT02037984|142934246|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71708267|NCT02037984|142934246|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71708268|NCT02037984|142934246|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.6|-14.0|
71708269|NCT02037984|142934246|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|85.0|||||TWO_SIDED|95.0|65.8|93.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||93.6|65.8|
71708270|NCT02037984|142934246|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|92.9|||||TWO_SIDED|95.0|75.1|98.1|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.1|75.1|
71826443|NCT04173572|143157483|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.39|STANDARD_DEVIATION|4.67|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
71826444|NCT04173572|143157483|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.43|STANDARD_DEVIATION|9.4|||TWO_SIDED|||||||||Posttreatment - Baseline: 11 participants analyzed (had data at both time points)||||
71826445|NCT04173572|143157484|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-3.667|STANDARD_DEVIATION|9.067|||TWO_SIDED|||||||||Posttreatment - Baseline: 15 participants analyzed (had data at both time points)||||
71655064|NCT01763918|142828026|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|8.38|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|4.36|12.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||12.40|4.36|<0.001
71655065|NCT01763918|142828026|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.48|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|5.1|13.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.85|5.10|<0.001
71655066|NCT01763918|142828027|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|4.66|13.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||13.74|4.66|<0.001
71655067|NCT01763918|142828027|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.07|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|3.48|1466.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||1466|3.48|<0.001
71655068|NCT01763918|142828028|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.63|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-29.46|-15.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-15.81|-29.46|<0.001
71655069|NCT01763918|142828028|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.54|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.25|-7.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-7.84|-23.25|<0.001
71655070|NCT01763918|142828029|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|4.21|<|0.001|TWO_SIDED|95.0|-29.29|-12.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||-12.66|-29.29|<0.001
71655071|NCT01763918|142828029|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-9.17|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|95.0|-19.01|0.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||||0.68|-19.01|<0.001
71655072|NCT03395639|142828030|OTHER|Difference in adjudicated major or CRNM bleeding rates were assessed.|Annualized rate difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12||||||||0.12|-0.18|
71655073|NCT03395639|142828030|OTHER|Difference in adjudicated major bleeding rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
71655074|NCT03395639|142828030|OTHER|Difference in all adjudicated bleeding (major, CRNM, minor) rates were assessed.|Annualized rate difference|0.0|||||TWO_SIDED|95.0|-0.24|0.25||||||||0.25|-0.24|
71655075|NCT00942331|142828038|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1707|TWO_SIDED|95.0|0.72|1.06|||Log Rank|Stratified log rank||||1.06|0.72|0.1707
71708271|NCT02037984|142934247|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
71886596|NCT01340209|143293515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.398|STANDARD_ERROR_OF_MEAN|9.245||0.0766|TWO_SIDED|95.0|-1.759|34.555|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||34.555|-1.759|0.0766
71886597|NCT01340209|143293516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.601|STANDARD_ERROR_OF_MEAN|1.038||0.5629|TWO_SIDED|95.0|-2.637|1.436|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 2.5 µg minus placebo||1.436|-2.637|0.5629
71655076|NCT03832738|142828062|SUPERIORITY||Odds Ratio (OR)|1.5||||0.558|TWO_SIDED|95.0|0.39|5.8||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.80|0.39|0.558
71708272|NCT02037984|142934247|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|24.3|||||TWO_SIDED|95.0|12.6|40.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||40.2|12.6|
71708273|NCT02037984|142934247|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|2.7|||||TWO_SIDED|95.0|-8.0|14.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||14.0|-8.0|
71765113|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|3.4||||0.341|TWO_SIDED|95.0|-2.38|9.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 24||9.16|-2.38|0.341
71708274|NCT02037984|142934247|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71886598|NCT01340209|143293516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.564|STANDARD_ERROR_OF_MEAN|1.038||0.5871|TWO_SIDED|95.0|-1.473|2.601|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment\*week and baseline\*week||Difference calculated as Tiotropium 5 μg minus placebo||2.601|-1.473|0.5871
71826446|NCT04173572|143157484|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.071|STANDARD_DEVIATION|12.25|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
71826447|NCT04173572|143157485|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|9.9|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
71826448|NCT04173572|143157485|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|0.714|STANDARD_DEVIATION|11.717|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
71826449|NCT04173572|143157486|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|3.071|STANDARD_DEVIATION|10.737|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
71826450|NCT04173572|143157486|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|5.571|STANDARD_DEVIATION|9.288|||TWO_SIDED|||||||||Posttreatment - Baseline: 14 participants analyzed (had data at both time points)||||
71886599|NCT02475655|143293540|SUPERIORITY|||||||0.67||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.||||0.67
71886600|NCT02475655|143293543|SUPERIORITY||Mean Difference (Net)|0.85||||0.18|TWO_SIDED|90.0|0.69|1.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.||1.04|0.69|0.18
71655077|NCT03832738|142828062|SUPERIORITY||Odds Ratio (OR)|3.74||||0.035|TWO_SIDED|95.0|1.07|13.1||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||13.10|1.07|0.035
71655078|NCT03832738|142828063|SUPERIORITY||Odds Ratio (OR)|2.26||||0.086|TWO_SIDED|95.0|0.89|5.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||5.75|0.89|0.086
71655079|NCT03832738|142828063|SUPERIORITY||Odds Ratio (OR)|3.76||||0.006|TWO_SIDED|95.0|1.45|9.75||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||9.75|1.45|0.006
71655080|NCT03832738|142828064|SUPERIORITY||Odds Ratio (OR)|1.0|||>|0.999|TWO_SIDED|95.0|0.06|17.25||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||17.25|0.06|>0.999
71655081|NCT03832738|142828064|SUPERIORITY||Odds Ratio (OR)|3.86||||0.244|TWO_SIDED|95.0|0.36|41.2||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||41.20|0.36|0.244
71655082|NCT03832738|142828066|SUPERIORITY||Odds Ratio (OR)|5.21||||0.009|TWO_SIDED|95.0|1.38|19.62||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||19.62|1.38|0.009
71655083|NCT03832738|142828066|SUPERIORITY||Odds Ratio (OR)|7.35||||0.002|TWO_SIDED|95.0|1.86|29.08||p-value was estimated based on Cochran-Mantel-Haenszel test stratified by prior exposure to biologic therapy (Yes/No) and body weight (\<90 kg/≥90 kg).|Cochran-Mantel-Haenszel|||||29.08|1.86|0.002
71655084|NCT02220725|142828081|SUPERIORITY||Hodges-Lehman estimate of shift|-70.14|||<|0.0001|TWO_SIDED|95.0|-85.43|-65.91|||2-sided test exact Wilcoxon rank-sum tes|||||-65.91|-85.43|<0.0001
71655085|NCT02220725|142828081|SUPERIORITY||Hodges-Lehman estimate of shift|-51.87|||<|0.0001|TWO_SIDED|95.0|-57.95|-47.03|||2-sided test exact Wilcoxon rank-sum tes|||||-47.03|-57.95|<0.0001
71655086|NCT02220725|142828082|SUPERIORITY||Hodges-Lehman estimate of shift|-74.45|||<|0.0001|TWO_SIDED|95.0|-78.92|-64.45|||2-sided test exact Wilcoxon rank-sum tes|||||-64.45|-78.92|<0.0001
71655087|NCT02220725|142828084|SUPERIORITY||Hodges-Lehmann Estimate of Shift|-18.0|||<|0.0001|TWO_SIDED|95.0|-23.05|-12.73|||2-sided test exact Wilcoxon rank-sum tes|||||-12.73|-23.05|<0.0001
71655088|NCT02220725|142828085|SUPERIORITY||Hodges-Lehman estimate of shift|1142.66|||<|0.0001|TWO_SIDED|95.0|1006.1|1281.4|||2-sided test exact Wilcoxon rank-sum tes|||||1281.40|1006.10|<0.0001
71655089|NCT02220725|142828085|SUPERIORITY||Hodges-Lehman estimate of shift|1205.05|||<|0.0001|TWO_SIDED|95.0|1034.17|1400.79|||2-sided test exact Wilcoxon rank-sum tes|||||1400.79|1034.17|<0.0001
71655090|NCT00103402|142828115|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|0.1||||0.99|TWO_SIDED|95.0|-11.2|11.0|||Mantel Haenszel|The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.||Sample-size calculations were based on a 2-sided alpha of 0.05 with 80% power to detect a difference of 20 between response rates (40% placebo and 60% alfuzosin) for the Fisher's exact test. We calculated that a total sample of 270 participants would be required (135 per study group). This proposed sample size included a 20% increase to adjust for clustering within clinical sites and a 5% increase for interim monitoring.||11.0|-11.2|0.99
71655091|NCT00103402|142828116|SUPERIORITY|The primary analysis compared rates for the primary outcome between study groups, using the exact conditional test version of the Mantel-Haenszel test to control for clustering by clinical center.|Risk Difference (RD)|1.8||||0.9|TWO_SIDED|95.0|-9.0|2.5|||Mantel Haenszel|||Marked or moderate improvement at 12 weeks Absolute Difference in Rates % (95% CI)||2.5|-9.0|0.90
71708275|NCT02037984|142934247|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708276|NCT02037984|142934247|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
71708277|NCT02037984|142934247|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708278|NCT02037984|142934247|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708279|NCT02037984|142934247|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708280|NCT02037984|142934247|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708281|NCT02037984|142934247|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708282|NCT02037984|142934247|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.6|
71708283|NCT02037984|142934247|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-3.0|||||TWO_SIDED|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.7|-15.5|
71886601|NCT02475655|143293545|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.||||0.40
71708284|NCT02037984|142934247|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71708285|NCT02037984|142934247|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.7|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.7|
71708286|NCT02037984|142934248|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708287|NCT02037984|142934248|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|18.4|||||TWO_SIDED|95.0|1.7|35.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||35.5|1.7|
71708288|NCT02037984|142934248|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-14.9|||||TWO_SIDED|95.0|-31.4|-1.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||-1.2|-31.4|
71708289|NCT02037984|142934248|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71765114|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|18.3||||0.004|TWO_SIDED|95.0|8.4|28.27|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 28||28.27|8.40|0.004
71765115|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|24.1|||<|0.001|TWO_SIDED|95.0|13.88|34.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 36||34.40|13.88|<0.001
71708290|NCT02037984|142934248|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708291|NCT02037984|142934248|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71765116|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|27.1|||<|0.001|TWO_SIDED|95.0|16.85|37.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 44||37.35|16.85|<0.001
71886602|NCT02475655|143293549|SUPERIORITY||Mean Difference (Net)|1.31||||0.7|TWO_SIDED|90.0|-4.27|6.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.||6.90|-4.27|0.70
71708292|NCT02037984|142934248|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708293|NCT02037984|142934248|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71886603|NCT02475655|143293549|SUPERIORITY||Mean Difference (Net)|1.61||||0.69|TWO_SIDED|90.0|-5.06|8.29||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.||8.29|-5.06|0.69
71886604|NCT02475655|143293549|SUPERIORITY||Mean Difference (Net)|6.35||||0.09|TWO_SIDED|90.0|0.16|12.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.||12.5|0.16|0.09
71826451|NCT03368001|143157520|OTHER|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses. We accounted for any non-independence of observations due to cohort membership by obtaining cluster-robust standard errors using robust maximum likelihood estimation (MLR in Mplus) in tandem with the Type = Complex option available in Mplus, treating cohorts as clusters. All models were structurally saturated, so model fit was necessarily perfect.||||||0.039||||||IFM Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Population models were specified using parameter values derived from past research in tandem with minimal expected effect sizes for the effects of most interest. These models were used to generate 5000 samples for a given N, the models were fit to each sample, and the significance (or not) of key effects was noted. This process was repeated until the target power of at least .80 was reached indicating with 216 participants we would have .82 power.||||.039
71708294|NCT02037984|142934248|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708295|NCT02037984|142934248|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708296|NCT02037984|142934248|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708297|NCT02037984|142934248|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-10.3|
71708298|NCT02037984|142934248|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-5.9|||||TWO_SIDED|95.0|-19.2|3.9|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.9|-19.2|
71708299|NCT02037984|142934248|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71708300|NCT02037984|142934248|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||TWO_SIDED|95.0|85.9|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||99.5|85.9|
71708301|NCT02037984|142934249|OTHER|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
71708302|NCT02037984|142934249|OTHER|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.0|||||TWO_SIDED|95.0|-5.5|32.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||32.0|-5.5|
71708303|NCT02037984|142934249|OTHER|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.6|||||TWO_SIDED|95.0|-24.2|5.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||5.2|-24.2|
71708304|NCT02037984|142934249|OTHER|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
71708305|NCT02037984|142934249|OTHER|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71708306|NCT02037984|142934249|OTHER|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71708307|NCT02037984|142934249|OTHER|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71708308|NCT02037984|142934249|OTHER|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
71708309|NCT02037984|142934249|OTHER|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71708310|NCT02037984|142934249|OTHER|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
71708311|NCT02037984|142934249|OTHER|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|-6.9|||||TWO_SIDED|95.0|-22.1|3.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||3.0|-22.1|
71708312|NCT02037984|142934249|OTHER|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|-3.4|||||TWO_SIDED|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||6.3|-17.3|
71708313|NCT02037984|142934249|OTHER|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||9.5|-11.9|
71708314|NCT02037984|142934249|OTHER|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||TWO_SIDED|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||95.7|75.2|
71708315|NCT02037984|142934249|OTHER|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|93.8|||||TWO_SIDED|95.0|78.5|98.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.|||98.3|78.5|
71708316|NCT02931539|142934260|SUPERIORITY||Difference in percentage of responders|32.8|||<|0.001|TWO_SIDED|95.0|22.8|42.74|||Cochran-Mantel-Haenszel|||||42.74|22.80|<0.001
71708317|NCT02931539|142934261|SUPERIORITY||Difference in percentage of responders|9.5||||0.013|TWO_SIDED|95.0|2.02|16.88|||Cochran-Mantel-Haenszel|||||16.88|2.02|0.013
71708318|NCT02931539|142934276|OTHER||Hazard Ratio (HR)|1.14||||0.647|TWO_SIDED|95.0|0.549|2.357|||Log Rank|Two-sided p-value comparing treatment groups was calculated from the log rank test by Kaplan-Meier Method.|Stratified Cox regression model was used as transplant type and baseline plasma CMV DNA level as stratification factors.|||2.357|0.549|0.647
71708319|NCT02059642|142934286|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.1||||0.1358|TWO_SIDED|95.0|-4.87|0.66|||Mixed Models Analysis|MMRM: Model of Repeated Measures||||0.66|-4.87|0.1358
71708320|NCT03061214|142934300|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
71708321|NCT03061214|142934300|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
71708322|NCT03061214|142934300|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.70|-1.00|<.0001
71708323|NCT03061214|142934300|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.||-0.36|-0.66|<.0001
71708324|NCT03211858|142934383|NON_INFERIORITY|Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was \<0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was \> -0.3%.|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.192|0.039|||||SAR341402 vs NovoLog/NovoRapid|Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.||0.039|-0.192|
71708325|NCT01866150|142934401|SUPERIORITY_OR_OTHER||Treatment Difference|1.2||||0.8222|TWO_SIDED|95.0|-9.5|12.0|||Pearson's chi-squared|||A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||12.0|-9.5|0.8222
71708326|NCT01866150|142934402|SUPERIORITY_OR_OTHER||Treatment Difference|3.7||||0.4727|TWO_SIDED|95.0|-6.2|13.6|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.6|-6.2|0.4727
71708327|NCT01866150|142934402|SUPERIORITY_OR_OTHER||Treatment Difference|2.6||||0.6349|TWO_SIDED|95.0|-8.0|13.1|||Pearson's chi-squared|||Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.||13.1|-8.0|0.6349
71826452|NCT03368001|143157520|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator.|Structural Equation Model (SEM)|0.064|||<|0.05|TWO_SIDED|90.0|0.014|0.118||One-tailed significance test|Structural Equation Model (SEM)|Controlling for Verbal Expressiveness at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The indirect effect of SENSE Theatre® vs. TTT through post-test IFM on follow-up Vocal Expressiveness. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.118|0.014|<0.05
71708328|NCT01866150|142934403|SUPERIORITY_OR_OTHER||Slope|-0.9||||0.8769|TWO_SIDED|95.0|-12.1|10.4|||Pearson's chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||10.4|-12.1|0.8769
71708329|NCT01866150|142934403|SUPERIORITY_OR_OTHER||Treatment Difference|3.4||||0.5649|TWO_SIDED|95.0|-8.2|15.0|||Pearson's chi-squared|||Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||15.0|-8.2|0.5649
71708330|NCT01866150|142934403|SUPERIORITY_OR_OTHER||Treatment Difference|9.9||||0.0556|TWO_SIDED|95.0|-0.3|20.2|||Pearson's chi-squared|||Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.||20.2|-0.3|0.0556
71826453|NCT03368001|143157520|OTHER|The residual associated with the mediator was allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.032|||<|0.05|TWO_SIDED|90.0|0.002|0.087||One-sided hypothesis test.|Structural Equation Model (SEM)|Controlling for Rapport at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Quality of Rapport through posttest Incidental Face Memory. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag (pretest to posttest) and baseline mediator, and controlled the outcome for individual differences in lag (pretest to follow-up) and baseline outcome.||0.087|0.002|<0.05
71708331|NCT01866150|142934404|SUPERIORITY_OR_OTHER||Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.152||0.5195|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.20|-0.40|0.5195
71708332|NCT01866150|142934404|SUPERIORITY_OR_OTHER||Treatment difference|-0.17|STANDARD_ERROR_OF_MEAN|0.149||0.242|TWO_SIDED|95.0|-0.47|0.12|||Mixed Models Analysis|||Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.12|-0.47|0.2420
71708333|NCT01866150|142934404|SUPERIORITY_OR_OTHER||Treatment difference|-0.15|STANDARD_ERROR_OF_MEAN|0.154||0.3264|TWO_SIDED|95.0|-0.45|0.15|||Mixed Models Analysis|||Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.||0.15|-0.45|0.3264
71708334|NCT01866150|142934406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81||||0.0237|TWO_SIDED|95.0|-16.44|-1.18|||General Linear Model|||Analysis was performed using a general linear model with cohort as a factor.||-1.18|-16.44|0.0237
71708335|NCT03160573|142934428|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Flavored Rinse, Placebo Flavored Rinse||||<0.00001
71708336|NCT03160573|142934428|SUPERIORITY||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||Test Unflavored Rinse, Placebo Unflavored Rinse||||<0.00001
71826454|NCT03368001|143157520|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|0.005|||>|0.05|TWO_SIDED|90.0|-0.015|0.059||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for Social Anxiety at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up Social Anxiety through posttest IFM. Adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.059|-0.015|>0.05
71708337|NCT01423084|142934439|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain||1.23|0.82|
71708338|NCT01423084|142934439|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain||1.1|0.77|
71708339|NCT01423084|142934439|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.81|||||TWO_SIDED|95.0|0.6|1.09||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain||1.09|0.6|
71708340|NCT01423084|142934447|NON_INFERIORITY_OR_EQUIVALENCE|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.83|||||TWO_SIDED|95.0|0.67|1.02||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs||1.02|0.67|
71765117|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|24.0|||<|0.001|TWO_SIDED|95.0|13.61|34.42|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: LDA: Week 52||34.42|13.61|<0.001
71708341|NCT02462057|142934455|EQUIVALENCE|The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71708342|NCT02336555|142934456|SUPERIORITY||Mean Difference (Final Values)|-0.452||||0.075|TWO_SIDED|95.0|-1.076|0.172||Linear mixed model with a posterior probability evaluation for the treatment effect|Linear mixed model|One-sided p-value and a posterior probability greater than 90% that the treatment effect is less than 0.||||0.172|-1.076|0.075
71708343|NCT02336555|142934457|SUPERIORITY||Odds Ratio (OR)|1.073|||||TWO_SIDED|95.0|0.446|2.58|||||Logistic regression model with factors for treatment \& baseline pain intensity|||2.580|0.446|
71708344|NCT01633112|142934458|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.0138|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.0138
71826455|NCT03368001|143157520|OTHER|The residuals associated with the mediator and outcome were allowed to covary with the lag and pretest scores associated with the outcome, and the residual associated with the outcome was allowed to covary with the lag and pretest scores associated with the mediator, yielding a saturated model.|Structural Equation Model (SEM)|-0.0002|||>|0.05|TWO_SIDED|90.0|-0.054|0.061||One-sided hypothesis test|Structural Equation Model (SEM)|Controlling for SRS-2 Social Communication at Pretest and the interval between Pretest and the Followup assessments.|Estimation parameter represents indirect effect (axb)|The partially standardized indirect effect of treatment on follow-up SRS Communication. We adjusted standard errors for cohort, controlled the mediator for individual differences in lag between pretest and posttest for the a path and controlled the outcome for individual differences in lag between pretest to follow-up for the b and c' paths.||0.061|-0.054|>0.05
71826456|NCT03368001|143157521|OTHER|||||||0.49||||||SRS Communication Posttest.|Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||||||.490
71826457|NCT03368001|143157522|OTHER|Posttest ANCOVA controlling for pre-test scores||||||0.704|||||||ANCOVA|||||||0.704
71886605|NCT02475655|143293551|SUPERIORITY||Mean Difference (Net)|-0.02||||0.58|TWO_SIDED|90.0|-0.06|0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.||0.03|-0.06|0.58
71708345|NCT01633112|142934458|SUPERIORITY|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.4153|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA||||0.4153
71826458|NCT03368001|143157522|OTHER|Followup ANCOVA controlling for pretest values||||||0.406|||||||ANCOVA|||||||0.406
71826459|NCT03368001|143157523|OTHER|||||||0.217|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses.||Vocal Expressiveness Posttest.||||.217
71826460|NCT03368001|143157523|OTHER|||||||0.448|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Quality of Rapport Posttest.||||.448
71708346|NCT01633112|142934459|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
71826461|NCT03368001|143157523|OTHER|||||||0.15|||||||Structural Equation Modeling|We used structural equation modeling (SEM), as implemented in Mplus 8.7, as a framework for testing all primary hypotheses||Social Anxiety Posttest.||||.150
71826462|NCT03368001|143157524|OTHER|Posttest ANCOVA controlling for pre-test values||||||0.169|||||||ANCOVA|||||||0.169
71886606|NCT02475655|143293551|SUPERIORITY||Mean Difference (Net)|-0.01||||0.79|TWO_SIDED|90.0|-0.06|0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.||0.04|-0.06|0.79
71886607|NCT02475655|143293551|SUPERIORITY||Mean Difference (Net)|-0.07||||0.016|TWO_SIDED|90.0|-0.11|-0.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.||-0.02|-0.11|0.016
71765118|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|2.3||||0.774|TWO_SIDED|95.0|-5.5|10.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 24||10.06|-5.50|0.774
71765119|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|0.4||||0.645|TWO_SIDED|95.0|-7.15|8.03|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 28||8.03|-7.15|0.645
71765120|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|8.4||||0.08|TWO_SIDED|95.0|0.36|16.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 36||16.35|0.36|0.080
71708347|NCT01633112|142934459|OTHER||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||<0.0001
71708348|NCT01633112|142934461|OTHER||||||<|0.0001|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||<0.0001
71765121|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|9.6||||0.025|TWO_SIDED|95.0|1.49|17.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 44||17.68|1.49|0.025
71826463|NCT03368001|143157524|OTHER|Followup ANCOVA controlling for pretest values.||||||0.555|||||||ANCOVA|||||||0.555
71826464|NCT00556543|143157591|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation performed.||||||0.19||95.0|||||Fisher Exact|||Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.||||0.190
71826465|NCT01838551|143157602|SUPERIORITY|Under the null hypothesis of at most 20% UFC responders, 90 subjects in the ITT population would provide 90% power, with two-sided type 1 error of 0.05, assuming an observed response of 35%.||||||0.0154||||||One-sided p-value is based on a null hypothesis that true response proportion is ≤ 0.20.|Mixed Models Analysis|The Generalized Linear Model described above was used to generate the p-value.||The least squares mean (LSMEAN) estimate of the UFC response after 6 months of treatment in the Maintenance Phase alongside its 95% Wald CI is presented. Supportive to the 95% CI, the p-value corresponding to the null hypothesis that the response rate is ≤ 20% is presented (1-sided test).||||0.0154
71826466|NCT02317016|143157649|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% confidence intervals (CIs) for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric least-squares (LS) mean ratio|171.92|||||TWO_SIDED|90.0|145.94|202.53|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed Cmax values were compared between treatments using a mixed effects analysis of variance (ANOVA) with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both area under the plasma concentration-time curve (AUC) and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||202.53|145.94|
71826467|NCT02317016|143157650|NON_INFERIORITY_OR_EQUIVALENCE|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% CIs for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric LS Mean Ratio|134.63|||||TWO_SIDED|90.0|115.41|157.07|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed AUC values were compared between treatments using a mixed effects ANOVA with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both AUC and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.||157.07|115.41|
71826468|NCT00536380|143157663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.721||95.0|||||ANCOVA|||||||0.721
71826469|NCT00605033|143157673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.|Proportion difference|-0.054|||||TWO_SIDED|95.0|-0.142|0.034|||Binomial approximation|||||0.034|-0.142|
71765122|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.088|TWO_SIDED|95.0|1.02|16.88|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Remission: Week 52||16.88|1.02|0.088
71765123|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|0.6||||0.358|TWO_SIDED|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Baseline||1.81|-0.59|0.358
71765124|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.258|TWO_SIDED|95.0|-3.57|10.13|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 24||10.13|-3.57|0.258
71765125|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|17.7||||0.005|TWO_SIDED|95.0|7.49|27.92|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 28||27.92|7.49|0.005
71765126|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|27.2|||<|0.001|TWO_SIDED|95.0|16.93|37.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 36||37.55|16.93|<0.001
71708349|NCT01633112|142934461|OTHER|||||||0.006|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.||||||0.0060
71708350|NCT01633112|142934462|OTHER|||||||0.0167|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .||||||0.0167
71708351|NCT01633112|142934462|OTHER|||||||0.0011|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.||||||0.0011
71765127|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|32.0|||<|0.001|TWO_SIDED|95.0|21.83|42.23|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 44||42.23|21.83|<0.001
71765128|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|28.3|||<|0.001|TWO_SIDED|95.0|18.0|38.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: LDA: Week 52||38.69|18.00|<0.001
71765129|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|3.0||||0.672|TWO_SIDED|95.0|-5.51|11.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 24||11.51|-5.51|0.672
71765130|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.556|TWO_SIDED|95.0|-8.03|8.0|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 28||8.00|-8.03|0.556
71765131|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|10.3||||0.022|TWO_SIDED|95.0|2.07|18.45|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 36||18.45|2.07|0.022
71765132|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|9.0||||0.047|TWO_SIDED|95.0|0.85|17.25|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 44||17.25|0.85|0.047
71886608|NCT02475655|143293553|SUPERIORITY||Mean Difference (Net)|-679.0||||0.018|TWO_SIDED|90.0|-1146.0|-212.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.||-212|-1146|0.018
71655092|NCT00103402|142828117|SUPERIORITY||Mean Difference (Net)|-0.5||||0.7|TWO_SIDED|95.0|-2.7|1.5|||t-test, 2 sided|||Total score (0-43) change from baseline||1.5|-2.7|0.70
71655093|NCT00103402|142828117|SUPERIORITY||Mean Difference (Net)|-0.3||||0.64|TWO_SIDED|95.0|-1.4|0.8|||t-test, 2 sided|||Pain score (0-21) change from baseline||0.8|-1.4|0.64
71655094|NCT00103402|142828117|SUPERIORITY||Mean Difference (Net)|-0.2||||0.62|TWO_SIDED|95.0|-0.8|0.4|||t-test, 2 sided|||Urinary score (0-10) change from baseline||0.4|-0.8|0.62
71655095|NCT00103402|142828117|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Quality of life score (0-12) change from baseline||0.4|-0.4|.99
71655096|NCT00103402|142828118|SUPERIORITY||Mean Difference (Net)|-0.3||||0.45|TWO_SIDED|95.0|-1.8|1.2|||t-test, 2 sided|||McGill Total Score||1.2|-1.8|0.45
71655097|NCT00103402|142828118|SUPERIORITY||Mean Difference (Net)|-0.2||||0.47|TWO_SIDED|95.0|-1.4|1.0|||t-test, 2 sided|||McGill Sensory Score||1.0|-1.4|0.47
71655098|NCT00103402|142828118|SUPERIORITY||Mean Difference (Net)|-0.1||||0.89|TWO_SIDED|95.0|-0.6|0.4|||t-test, 2 sided|||McGill Affective Score||0.4|-0.6|0.89
71655099|NCT00103402|142828119|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6|TWO_SIDED|95.0|-2.3|1.3|||t-test, 2 sided|||Physical component summary (0-100) change in scores||1.3|-2.3|0.60
71765133|NCT01578850|143032734|SUPERIORITY_OR_OTHER||Difference in proportions|12.1||||0.031|TWO_SIDED|95.0|3.7|20.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Remission: Week 52||20.57|3.70|0.031
71765134|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.049|TWO_SIDED|95.0|-4.19|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 28||-0.01|-4.19|0.049
71765135|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.72|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 36||-1.05|-5.72|0.005
71765136|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.37|-1.67|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 44||-1.67|-6.37|<0.001
71765137|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|||<|0.001|TWO_SIDED|95.0|-6.36|-1.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CDAI: Week 52||-1.68|-6.36|<0.001
71765138|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.047|TWO_SIDED|95.0|-4.4|-0.03|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 28||-0.03|-4.40|0.047
71765139|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.004|TWO_SIDED|95.0|-5.97|-1.12|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 36||-1.12|-5.97|0.004
71655100|NCT00103402|142828119|SUPERIORITY||Mean Difference (Net)|2.1||||0.16|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||Mental component summary (0-100) Absolute Difference between Groups (95% CI)||4.6|-0.4|0.16
71655101|NCT00103402|142828120|SUPERIORITY||Mean Difference (Net)|-1.1||||0.08|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||||0.2|-2.4|0.08
71655102|NCT00103402|142828121|SUPERIORITY||Risk Difference (RD)|0.7||||0.94|TWO_SIDED|95.0|-2.6|4.0|||t-test, 2 sided|||||4.0|-2.6|0.94
71655103|NCT00103402|142828122|SUPERIORITY||Mean Difference (Net)|1.1||||0.06|TWO_SIDED|95.0|-0.3|2.5|||t-test, 2 sided|||||2.5|-0.3|0.06
71655104|NCT00986453|142828129|SUPERIORITY_OR_OTHER|||||||0.4697||95.0|||||t-test, 2 sided|||||||0.4697
71655105|NCT00986453|142828130|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||t-test, 2 sided|||||||0.1470
71655106|NCT00986453|142828131|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
71655107|NCT00986453|142828132|SUPERIORITY_OR_OTHER|||||||0.0776||95.0|||||t-test, 2 sided|||||||0.0776
71708352|NCT01633112|142934463|OTHER|||||||0.0052|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0052
71708353|NCT01633112|142934463|OTHER|||||||0.0636|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.||||||0.0636
71708354|NCT01633112|142934464|OTHER|||||||0.0011||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0011
71708355|NCT01633112|142934464|OTHER|||||||0.0146||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.||||||0.0146
71708356|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708357|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708358|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708359|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708360|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708361|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708362|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71765140|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33|||<|0.001|TWO_SIDED|95.0|-6.78|-1.88|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 44||-1.88|-6.78|<0.001
71765141|NCT01578850|143032736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27|||<|0.001|TWO_SIDED|95.0|-6.7|-1.84|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||SDAI: Week 52||-1.84|-6.70|<0.001
71765142|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|-0.2||||0.742|TWO_SIDED|95.0|-4.21|3.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 24||3.90|-4.21|0.742
71765143|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|9.8||||0.143|TWO_SIDED|95.0|2.45|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 28||17.06|2.45|0.143
71765144|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|11.4||||0.111|TWO_SIDED|95.0|3.31|19.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 36||19.51|3.31|0.111
71765145|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|10.1||||0.175|TWO_SIDED|95.0|1.8|18.49|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 44||18.49|1.80|0.175
71765146|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|10.8||||0.088|TWO_SIDED|95.0|2.49|19.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 20: Week 52||19.05|2.49|0.088
71765147|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|2.5||||0.584|TWO_SIDED|95.0|-4.78|9.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 24||9.75|-4.78|0.584
71765148|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|11.5||||0.226|TWO_SIDED|95.0|1.59|21.34|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 28||21.34|1.59|0.226
71765149|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|17.2||||0.012|TWO_SIDED|95.0|6.76|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 36||27.56|6.76|0.012
71765150|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|19.0||||0.006|TWO_SIDED|95.0|8.59|29.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 44||29.35|8.59|0.006
71765151|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in Proportions|17.7||||0.014|TWO_SIDED|95.0|7.3|28.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 50: Week 52||28.16|7.30|0.014
71765152|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in Proportions|-2.7||||0.702|TWO_SIDED|95.0|-13.49|8.11|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 24||8.11|-13.49|0.702
71708363|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708364|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708365|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708366|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708367|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708368|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708369|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708370|NCT01633112|142934465|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline||||||0.0005
71708371|NCT01633112|142934465|OTHER||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0051
71826470|NCT03693742|143157686|SUPERIORITY||||||<|0.001||||||A P value of less than 0.05 was considered significant.|Mixed Models Analysis|||"Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups.~A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05."||||<0.001
71708372|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708373|NCT01633112|142934465|OTHER|||||||0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline||||||0.0051
71708374|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708375|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||<0.0001
71708376|NCT01633112|142934465|OTHER|||||||0.0068|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline||||||0.0068
71708377|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708378|NCT01633112|142934465|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||<0.0001
71708379|NCT01633112|142934465|OTHER|||||||0.4595|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline||||||0.4595
71708380|NCT01633112|142934466|OTHER|||||||0.1045|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1045
71708381|NCT01633112|142934466|OTHER|||||||0.1358|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume||||||0.1358
71708382|NCT01959919|142934467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.907||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between ease of using clotting factor treatment score at Final visit (Month 8) and baseline visit||||0.000
71708383|NCT01959919|142934468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.572|STANDARD_ERROR_OF_MEAN|0.584||0|TWO_SIDED|95.0|3.411|5.733|||t-test, 2 sided|||Comparison between time for reconstructing the drug at Final visit (Month 8) and baseline visit||5.733|3.411|0.000
71708384|NCT01959919|142934469|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.789||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between burden of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
71708385|NCT01959919|142934470|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.98||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between impact of clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.000
71708386|NCT01959919|142934471|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.445||||0.001|||||||Wilcoxon Signed Ranks Test|||Comparison between risk associated with clotting factor treatment score at Final Visit Month 8 and baseline visit||||0.001
71708387|NCT01697501|142934480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7831|TWO_SIDED|95.0|0.29|2.57|||univariate logistic analysis|||||2.57|0.29|0.7831
71708388|NCT01697501|142934481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.1951|TWO_SIDED|95.0|0.66|7.67|||univariate logistic analysis|||||7.67|0.66|0.1951
71708389|NCT01697501|142934482|SUPERIORITY_OR_OTHER|||||||0.2642|TWO_SIDED||||||Wald Chi Square|||||||0.2642
71708390|NCT01697501|142934483|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Wald Chi Square|||||||0.0672
71708391|NCT03992872|142934488|SUPERIORITY|The significance of the difference between groups in seroconversion rates was assessed using a Fisher's exact test. The percentage who seroconverted in each group was presented along with its 95% CI calculated using the Wilson method. The Newcombe method was use to estimate the 95% confidence interval for the difference between groups in the percentage of subjects who seroconverted.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-11.4|11.4|||Fisher Exact|||||11.4|-11.4|1
71826471|NCT03720990|143157820|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
71826472|NCT00954707|143157824|SUPERIORITY_OR_OTHER||Rate of TLF at 12-month (%)|6.4|||||TWO_SIDED|95.0|5.5|7.5||||||||7.5|5.5|
71826473|NCT00954707|143157825|SUPERIORITY_OR_OTHER||Rate of device success (%)|98.0|||||TWO_SIDED|95.0|97.4|98.4||||||||98.4|97.4|
71655108|NCT00986453|142828133|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71655109|NCT01583218|142828134|SUPERIORITY||Relative Risk Reduction (RRR)|0.209||||0.038|TWO_SIDED|95.0|0.013|0.366|||Cochran-Mantel-Haenszel|||||0.366|0.013|0.038
71655110|NCT01583218|142828135|SUPERIORITY||Relative Risk Reduction (RRR)|0.216||||0.018|TWO_SIDED|95.0|0.041|0.359|||Cochran-Mantel-Haenszel|||||0.359|0.041|0.018
71655111|NCT01583218|142828136|SUPERIORITY||Relative Risk Reduction (RRR)|0.254||||0.003|TWO_SIDED|95.0|0.092|0.387|||Cochran-Mantel-Haenszel|||||0.387|0.092|0.003
71655112|NCT01583218|142828137|SUPERIORITY|||||||0.554|||||||Chi-squared|||||||0.554
71655113|NCT01583218|142828138|SUPERIORITY||Relative Risk Reduction (RRR)|0.326||||0.092|TWO_SIDED|95.0|-0.069|0.576|||Cochran-Mantel-Haenszel|||||0.576|-0.069|0.092
71655114|NCT01583218|142828139|SUPERIORITY||Relative Risk Reduction (RRR)|0.295||||0.11|TWO_SIDED|95.0|-0.085|0.542|||Cochran-Mantel-Haenszel|||||0.542|-0.085|0.11
71655115|NCT01583218|142828140|SUPERIORITY||Relative Risk Reduction (RRR)|0.358||||0.039|TWO_SIDED|95.0|0.02|0.58|||Cochran-Mantel-Haenszel|||||0.580|0.020|0.039
71655116|NCT03182582|142828165|SUPERIORITY|||||||0.003|||||||Paired t test|||A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.||||0.003
71655117|NCT03334721|142828176|SUPERIORITY|"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term. Analysis used Linear Mixed Modeling with Fixed Factors."|Test III Tests of Fixed Effects (F)|0.141||||0.711|TWO_SIDED|||||Treatment Condition Factor (0 = Placebo, 1 = Gabapentin)|Mixed Models Analysis|df = 1, 20.183|||"Given the crossover design through which the data were collected, the statistical model also included a Visit (1 vs. 2) factor and a Visit by Treatment Condition interaction term."|||0.711
71655118|NCT01663727|142828181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0007|TWO_SIDED|99.0|0.51|0.91|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.91|0.51|0.0007
71655119|NCT01663727|142828181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0046|TWO_SIDED|99.0|0.55|0.97|||Log Rank|||Unstratified Analysis.||0.97|0.55|0.0046
71655120|NCT01663727|142828181|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED||||||Wald Test|||A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.||||0.4619
71655121|NCT01663727|142828183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5877|TWO_SIDED|95.0|0.75|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.75|0.5877
71655122|NCT01663727|142828183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8004|TWO_SIDED|95.0|0.78|1.21|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.21|0.78|0.8004
71655123|NCT01663727|142828185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2745|TWO_SIDED|95.0|0.63|1.14|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.14|0.63|0.2745
71655124|NCT01663727|142828185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3616|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.17|0.65|0.3616
71655125|NCT01663727|142828186|SUPERIORITY_OR_OTHER||Difference in Response Rates|20.78|||<|0.0001|TWO_SIDED|95.0|11.45|30.11|||Fisher|||||30.11|11.45|<0.0001
71655126|NCT01663727|142828188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0038|TWO_SIDED|96.0|0.47|0.88|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||0.88|0.47|0.0038
71655127|NCT01663727|142828188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0101|TWO_SIDED|96.0|0.5|0.93|||Log Rank|||Unstratified analysis.||0.93|0.50|0.0101
71655128|NCT01663727|142828189|SUPERIORITY_OR_OTHER||Difference in Response Rates|21.53||||0.0017|TWO_SIDED|95.0|8.73|34.32|||Fisher|||||34.32|8.73|0.0017
71655129|NCT01663727|142828190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2737|TWO_SIDED|95.0|0.54|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.19|0.54|0.2737
71655130|NCT01663727|142828190|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.2959|TWO_SIDED|95.0|0.56|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.19|0.56|0.2959
71655131|NCT01663727|142828191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.1783|TWO_SIDED|95.0|0.41|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).||1.18|0.41|0.1783
71655132|NCT01663727|142828191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2429|TWO_SIDED|95.0|0.45|1.22|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.||1.22|0.45|0.2429
71655133|NCT02287909|142828208|SUPERIORITY||least square mean difference|-6.9|||>|0.05|TWO_SIDED|985.0|-38.0|24.0|||ANCOVA|||||24|-38|>0.05
71826474|NCT00954707|143157826|SUPERIORITY_OR_OTHER||Rate of lesion success (%)|99.8|||||TWO_SIDED|95.0|99.6|99.9||||||||99.9|99.6|
71826475|NCT00954707|143157827|SUPERIORITY_OR_OTHER||Rate of procedure success (%)|97.7|||||TWO_SIDED|95.0|97.0|98.2||||||||98.2|97.0|
71826476|NCT00954707|143157828|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TLR (%)|4.2|||||TWO_SIDED|95.0|3.45|5.13||||||||5.13|3.45|
71826477|NCT00954707|143157829|SUPERIORITY_OR_OTHER||Rate of Clinically-driven TVR (%)|5.8|||||TWO_SIDED|95.0|4.87|6.81||||||||6.81|4.87|
71826478|NCT00954707|143157830|SUPERIORITY_OR_OTHER||Rate of Target vessel failure (%)|7.92|||||TWO_SIDED|95.0|6.85|9.09||||||||9.09|6.85|
71826479|NCT00954707|143157831|SUPERIORITY_OR_OTHER||Rate of MACE (%)|7.41|||||TWO_SIDED|95.0|6.37|8.55||||||||8.55|6.37|
71826480|NCT00954707|143157832|SUPERIORITY_OR_OTHER||Rate of protocol defined ST (%)|0.91|||||TWO_SIDED|95.0|0.56|1.38||||||||1.38|0.56|
71826481|NCT00954707|143157833|SUPERIORITY_OR_OTHER||Rate of ARC defined ST (%)|1.12|||||TWO_SIDED|95.0|0.74|1.64||||||||1.64|0.74|
71826482|NCT00954707|143157834|SUPERIORITY_OR_OTHER||Rate of major bleeding complications (%)|3.07|||||TWO_SIDED|95.0|2.4|3.85||||||||3.85|2.40|
71655134|NCT00605865|142828243|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."||||<0.001
71655135|NCT00605865|142828244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."||||0.039
71655136|NCT00605865|142828245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.011
71655137|NCT00605865|142828246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||0.010
71655138|NCT00605865|142828247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."||||<0.001
71655139|NCT00605865|142828248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders."||||0.014
71655140|NCT00605865|142828249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.021
71655141|NCT00605865|142828250|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders."||||<0.001
71655142|NCT00605865|142828251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders."||||0.003
71655143|NCT00605865|142828252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders."||||0.012
71655144|NCT00605865|142828253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."||||0.019
71655145|NCT00605865|142828254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."||||0.010
71655146|NCT00605865|142828255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders."||||0.015
71655147|NCT00605865|142828256|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders."||||<0.001
71655148|NCT02119286|142828257|SUPERIORITY_OR_OTHER||Least squared mean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.091|0.152|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.152|0.091|<0.001
71655149|NCT02119286|142828257|SUPERIORITY_OR_OTHER||Least squared mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.081|0.141|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.141|0.081|<0.001
71655150|NCT02119286|142828258|SUPERIORITY_OR_OTHER||Least squared mean difference|0.147|||<|0.001|TWO_SIDED|95.0|0.114|0.179|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.179|0.114|<0.001
71655151|NCT02119286|142828258|SUPERIORITY_OR_OTHER||Least squared mean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.103|0.167|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.167|0.103|<0.001
71655152|NCT01388166|142828272|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71655153|NCT01388166|142828273|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71655154|NCT01388166|142828274|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71655155|NCT01429051|142828296|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.002|TWO_SIDED|95.0|0.41|1.179|||Mixed Models Analysis|A mixed effects model with episode baseline PI as a covariate, treatment as a fixed effect and patient as a random effect.||||1.179|0.41|0.002
71765153|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|7.1||||0.378|TWO_SIDED|95.0|-3.37|17.5|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 28||17.50|-3.37|0.378
71765154|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|17.3||||0.004|TWO_SIDED|95.0|7.12|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 36||27.56|7.12|0.004
71826483|NCT00954707|143157835|SUPERIORITY_OR_OTHER||Rate of cardiac death (%)|0.78|||||TWO_SIDED|95.0|0.46|1.23||||||||1.23|0.46|
71826484|NCT00954707|143157836|SUPERIORITY_OR_OTHER||Rate of non-cardiac death (%)|0.69|||||TWO_SIDED|95.0|0.4|1.12||||||||1.12|0.40|
71826485|NCT01710514|143157857|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative (Ha) by constructing two-sided 95%CI for the difference. The non-inferiority limit for the difference was pre-specified to -10.0% (absolute). If the lower limit of the two-sided 95%CI was greater than the non-inferiority limit (-10.0%) for both the FAS and per protocol set, the null hypothesis was to be rejected. In that case it would be claimed that the rate observed in this trial was non-inferior to the rate observed in the CS08 trial|Difference of % to historical control|-0.9|||||TWO_SIDED|95.0|-3.6|1.8||||||To verify sufficient supplementation of luteal hormone, the proportion of subjects with blood progesterone concentration ≥ 10 ng/mL on Day 5 was compared to the result from a historical control, trial CS08 (NCT number: 00884221). The corresponding proportion of subjects in trial CS08 was 99.8% (95%CI: 99.1;100.0, 631/632 subjects). The non-inferiority hypothesis tested for this primary endpoint was: H0: P(000072)-P(CS08) ≤ -10.0% against the alternative Ha: P(000072)-P(CS08) \> -10.0%.||1.8|-3.6|
71826486|NCT03383887|143157869|SUPERIORITY||Median Difference (Final Values)|2.7||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
71826487|NCT03383887|143157870|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
71655156|NCT03728634|142828320|SUPERIORITY||||||<|0.001|||||||Analysis of Variance(ANOVA)|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
71655157|NCT03728634|142828320|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
71655158|NCT03728634|142828320|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
71655159|NCT03728634|142828320|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
71655160|NCT03728634|142828320|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
71655161|NCT03728634|142828320|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
71655162|NCT03728634|142828320|SUPERIORITY|||||||0.036|||||||ANOVA|||Change From Baseline in Plasma TTR Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
71655163|NCT03728634|142828321|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 45 mg||||<0.001
71655164|NCT03728634|142828321|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 60 mg||||<0.001
71655165|NCT03728634|142828321|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 29: 90 mg||||<0.001
71655166|NCT03728634|142828321|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 45 mg||||<0.001
71655167|NCT03728634|142828321|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 60 mg||||<0.001
71655168|NCT03728634|142828321|SUPERIORITY||||||<|0.001|||||||ANOVA|||Change From Baseline in Plasma RBP4 Levels Following Multiple-Dose Administration of ION-TTR-LRx at Day 99: 90 mg||||<0.001
71655169|NCT03728634|142828321|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Exact Test (2-sided)|||Change From Baseline in Plasma RBP4 Levels Following Single-Dose Administration of ION-TTR-LRx at Day 29: 120 mg||||0.036
71655170|NCT04295135|142828323|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.001|<|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.05
71655171|NCT04295135|142828324|SUPERIORITY||Median Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
71655172|NCT04295135|142828325|SUPERIORITY||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.008|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
71886609|NCT02475655|143293553|SUPERIORITY||Mean Difference (Net)|-651.0||||0.021|TWO_SIDED|90.0|-1110.0|-192.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.||-192|-1110|0.021
71708392|NCT03992872|142934489|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.2|||||TWO_SIDED|95.0||||P- value = NE (Not estimable due to lack of response; all baseline values in this group were \<LOD and imputed as LOD/2, or 7.5)||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
71708393|NCT03992872|142934489|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|3.11||||0.0019|TWO_SIDED|95.0|1.55|6.23|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 8: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||6.23|1.55|0.0019
71708394|NCT03992872|142934489|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6223|TWO_SIDED|95.0|0.54|1.46|||ANOVA|P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.46|0.54|0.6223
71708395|NCT03992872|142934489|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.88||||0.6444|TWO_SIDED|95.0|0.5|1.55||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.55|0.50|0.6444
71708396|NCT03992872|142934489|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6198|TWO_SIDED|95.0|0.57|1.41||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 57: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.41|0.57|0.6198
71708397|NCT03992872|142934489|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|0.89||||0.6451|TWO_SIDED|95.0|0.55|1.45||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 182: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||1.45|0.55|0.6451
71708398|NCT03992872|142934490|SUPERIORITY|||||||0.0211|||||||Fisher Exact|"Day 8~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.0211
71708399|NCT03992872|142934490|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71708400|NCT03992872|142934490|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 57.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71708401|NCT03992872|142934490|SUPERIORITY|||||||0.1124|||||||Fisher Exact|"Day 182.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||0.1124
71708402|NCT03992872|142934491|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1 : Subjects with Titer \>=40"||||>0.9999
71765155|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|18.5||||0.001|TWO_SIDED|95.0|8.4|28.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 44||28.55|8.40|0.001
71765156|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|16.0||||0.005|TWO_SIDED|95.0|5.96|26.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 70: Week 52||26.02|5.96|0.005
71708403|NCT03992872|142934491|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 1: Subjects with Titer \>=160"||||>0.9999
71708404|NCT03992872|142934491|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 1: Subjects with Titer \>=640"||||1.0000
71708405|NCT03992872|142934491|SUPERIORITY|||||||0.0257|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8 : Subjects with Titer \>=40"||||0.0257
71708406|NCT03992872|142934491|SUPERIORITY|||||||0.037|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 8: Subjects with Titer \>=160"||||0.0370
71765157|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|-0.3||||0.921|TWO_SIDED|95.0|-6.19|5.67|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 24||5.67|-6.19|0.921
71765158|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|3.3||||0.41|TWO_SIDED|95.0|-2.19|8.86|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 28||8.86|-2.19|0.410
71708407|NCT03992872|142934491|SUPERIORITY|||||||0.1806|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 8: Subjects with Titer \>=640"||||0.1806
71708408|NCT03992872|142934491|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 22: Subjects with Titer \>=40"||||1.0000
71708409|NCT03992872|142934491|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=160"||||1.0000
71708410|NCT03992872|142934491|SUPERIORITY|||||||0.0797|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point~Day 22: Subjects with Titer \>=640"||||0.0797
71886610|NCT02475655|143293553|SUPERIORITY||Mean Difference (Net)|33.6||||0.91|TWO_SIDED|90.0|-461.0|528.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.||528|-461|0.91
71765159|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|6.4||||0.073|TWO_SIDED|95.0|0.41|12.48|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 36||12.48|0.41|0.073
71708411|NCT03992872|142934491|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=40"||||1.0000
71708412|NCT03992872|142934491|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>=160"||||1.0000
71708413|NCT03992872|142934491|SUPERIORITY|||||||0.1284|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 640"||||0.1284
71765160|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|4.6||||0.219|TWO_SIDED|95.0|-0.97|10.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 44||10.08|-0.97|0.219
71765161|NCT01578850|143032738|SUPERIORITY_OR_OTHER||Difference in proportions|5.9||||0.196|TWO_SIDED|95.0|-0.6|12.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ACR 90: Week 52||12.40|-0.60|0.196
71765162|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.062|TWO_SIDED|95.0|-1.84|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 28||0.05|-1.84|0.062
71765163|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.015|TWO_SIDED|95.0|-2.41|-0.27|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 36||-0.27|-2.41|0.015
71886611|NCT02475655|143293555|SUPERIORITY||Mean Difference (Net)|-0.13||||0.45|TWO_SIDED|90.0|-0.42|0.15||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.||0.15|-0.42|0.45
71886612|NCT02475655|143293555|SUPERIORITY||Mean Difference (Net)|-0.55||||0.005|TWO_SIDED|90.0|-0.87|-0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.||-0.23|-0.87|0.005
71708414|NCT03992872|142934491|SUPERIORITY|||||||1|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer \>= 40"||||1.0000
71708415|NCT03992872|142934491|SUPERIORITY|||||||0.6411|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=160"||||0.6411
71708416|NCT03992872|142934491|SUPERIORITY|||||||0.5382|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 57: Subject with Titer\>=640"||||0.5382
71765164|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65||||0.003|TWO_SIDED|95.0|-2.72|-0.57|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 44||-0.57|-2.72|0.003
71765165|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.002|TWO_SIDED|95.0|-2.85|-0.66|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Tender Joint Count: Week 52||-0.66|-2.85|0.002
71765166|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.68|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 28||0.50|-0.77|0.680
71765167|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.437|TWO_SIDED|95.0|-1.04|0.45|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 36||0.45|-1.04|0.437
71765168|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.131|TWO_SIDED|95.0|-1.31|0.17|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 44||0.17|-1.31|0.131
71708417|NCT03992872|142934491|SUPERIORITY|||||||0.4915|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 40"||||0.4915
71708418|NCT03992872|142934491|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 160"||||>0.9999
71708419|NCT03992872|142934491|SUPERIORITY|||||||0.552|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-Chikungunya neutralizing activity at or above selected thresholds by time point.~Day 182: Subject with Titer \>= 640"||||0.5520
71708420|NCT03992872|142934492|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.51||||0.0277|TWO_SIDED|95.0|1.05|2.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.19|1.05|0.0277
71708421|NCT03992872|142934492|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.83||||0.0088|TWO_SIDED|95.0|1.17|2.86||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.86|1.17|0.0088
71765169|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.199|TWO_SIDED|95.0|-1.22|0.25|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||28 Swollen Joint Count: Week 52||0.25|-1.22|0.199
71765170|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.115|TWO_SIDED|95.0|-2.6|0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 28||0.28|-2.60|0.115
71765171|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.017|TWO_SIDED|95.0|-3.42|-0.35|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 36||-0.35|-3.42|0.017
71765172|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.004|TWO_SIDED|95.0|-3.91|-0.76|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 44||-0.76|-3.91|0.004
71765173|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.002|TWO_SIDED|95.0|-4.19|-0.97|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Tender Joint Count: Week 52||-0.97|-4.19|0.002
71765174|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.368|TWO_SIDED|95.0|-1.13|0.42|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 28||0.42|-1.13|0.368
71765175|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.208|TWO_SIDED|95.0|-1.46|0.32|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 36||0.32|-1.46|0.208
71765176|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.064|TWO_SIDED|95.0|-1.73|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 44||0.05|-1.73|0.064
71765177|NCT01578850|143032740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.081|TWO_SIDED|95.0|-1.66|0.1|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||68 Swollen Joint Count: Week 52||0.10|-1.66|0.081
71765178|NCT01578850|143032742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.005|TWO_SIDED|95.0|-0.9|-0.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.16|-0.90|0.005
71765179|NCT01578850|143032742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.38|-1.18|<0.001
71886613|NCT02475655|143293555|SUPERIORITY||Mean Difference (Net)|0.15||||0.75|TWO_SIDED|90.0|-0.65|0.95||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.||0.95|-0.65|0.75
71886614|NCT02475655|143293557|SUPERIORITY||Mean Difference (Net)|37754.0|||<|0.001|TWO_SIDED|90.0|19609.0|55898.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.||55898|19609|<0.001
71886615|NCT02475655|143293557|SUPERIORITY||Mean Difference (Net)|27832.0||||0.012|TWO_SIDED|90.0|9849.0|45815.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.||45815|9849|0.012
71765180|NCT01578850|143032742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.54|-1.35|<0.001
71765181|NCT01578850|143032742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.53|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.53|-1.33|<0.001
71886616|NCT02475655|143293557|SUPERIORITY||Mean Difference (Net)|5376.0||||0.52|TWO_SIDED|90.0|-8592.0|19344.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.||19344|-8592|0.52
71708422|NCT03992872|142934492|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|1.68||||0.0475|TWO_SIDED|95.0|1.01|2.82||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||2.82|1.01|0.0475
71708423|NCT03992872|142934493|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
71708424|NCT03992872|142934493|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.00
71708425|NCT03992872|142934494|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|45.17|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE~NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\]~NE = Not estimable due to lack of response."|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
71708426|NCT03992872|142934494|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|47.34|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
71886617|NCT02475655|143293559|SUPERIORITY||Mean Difference (Net)|4.96||||0.05|TWO_SIDED|90.0|0.78|9.14||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.||9.14|0.78|0.05
71708427|NCT03992872|142934494|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|55.74|||||TWO_SIDED|||||"P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.~P-value = NE NE = Not estimable due to lack of response."|||"Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.~95% CI \[NE,NE\] NE = Not estimable due to lack of response."|Day 29: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||||
71708428|NCT03992872|142934496|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71708429|NCT03992872|142934496|SUPERIORITY|||||||1|||||||Fisher Exact|"Day 29.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||1.0000
71708430|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 40"||||<0.0001
71708431|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 160"||||<0.0001
71708432|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 1: Subject with Titer \>= 640"||||<0.0001
71708433|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 40"||||<0.0001
71708434|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>= 160"||||<0.0001
71708435|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 22: Subject with Titer \>=640"||||<0.0001
71708436|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subject with Titer \>= 40"||||<0.0001
71708437|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29: Subjects with Titer \>= 160"||||<0.0001
71708438|NCT03992872|142934497|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"Null hypothesis for analysis of percentage of subjects with Anti-VEEV PRNT neutralizing activity at or above selected thresholds by time point.~Day 29 : Subjects with Titer \>=640"||||<0.0001
71886618|NCT02475655|143293559|SUPERIORITY||Mean Difference (Net)|8.15|||<|0.001|TWO_SIDED|90.0|4.47|11.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.||11.8|4.47|<0.001
71886619|NCT02475655|143293559|SUPERIORITY||Mean Difference (Net)|3.95||||0.025|TWO_SIDED|90.0|1.08|6.81||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.||6.81|1.08|0.025
71708439|NCT03992872|142934498|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|23.12|||<|0.0001|TWO_SIDED|95.0|11.54|46.35||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 1: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||46.35|11.54|<0.0001
71708440|NCT03992872|142934498|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|172.51|||<|0.0001|TWO_SIDED|95.0|106.6|279.19||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 22: Geometric mean ratio (prior alpha group over naïve alpha group) and 95% confidence interval||279.19|106.60|<0.0001
71708441|NCT03992872|142934498|SUPERIORITY||GMR (Prior Alpha / Naïve Alpha)|118.45|||<|0.0001|TWO_SIDED|95.0|61.76|227.16||P-values were based on an ANOVA model with log10-transformed titer as the dependent variable and study arm, age, and gender as predictors.|ANOVA||Differences in least squares means from the ANOVA model were back-transformed and reported as geometric mean ratios with 95% confidence intervals.|Day 29: Geometric mean ratio (prior alpha group over naive alpha group) and 95% confidence interval||227.16|61.76|<0.0001
71708442|NCT03992872|142934499|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 22.~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
71708443|NCT03992872|142934499|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|"Day 29~Note: A subject has a 4-fold rise at a visit if they achieve a titer at that visit that is at least 4-fold higher than their Day 1 titer."||||||<0.0001
71708444|NCT00889005|142934501|SUPERIORITY_OR_OTHER|||||||0.927|||||||ANOVA|||||||0.927
71708445|NCT00318136|142934631|SUPERIORITY_OR_OTHER||Percentage of patients|3.2||||||90.0|0.3|13.5|||Blyth-Still-Casella|||||13.5|0.3|
71708446|NCT03769116|142934675|OTHER||Hodges-Lehmann treatment diff|6.11|||<|0.0001|TWO_SIDED|95.0|2.08|12.58|||Wilcoxon rank sum test|||Analysis conducted on changes from baseline.||12.58|2.08|< 0.0001
71708447|NCT03769116|142934676|OTHER||LSM Change Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9|=|0.373|TWO_SIDED|95.0|-1.0|2.7|||Mixed-model for Repeated Measures|||||2.7|-1.0|= 0.3730
71708448|NCT03769116|142934684|OTHER||LSM Change Difference|2.5|STANDARD_ERROR_OF_MEAN|0.9|=|0.0172|TWO_SIDED|95.0|0.5|4.4|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 4-5 years old||4.4|0.5|= 0.0172
71708449|NCT03769116|142934684|OTHER||LSM Change Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1|=|0.5384|TWO_SIDED|95.0|-3.0|1.6|||Mixed-model for Repeated Measures|||Change from baseline - Age Group: 6-7 years old||1.6|-3.0|= 0.5384
71708450|NCT02844075|142934687|SUPERIORITY||||||||||||||||||For sample size calculation, Minimax design to evaluate the null hypothesis that the true pCR rate will be 10% and the alternative hypothesis that the pCR rate≥ 30%, with type I error (α) level of 10% and type II error (β) of 0.10. If 1 or more successes are observed in the first 16 patients, accrual for that stratum will be continued until a total of 25 patients. If, of these 25 patients, 5 or more pCR, an additional investigation is warranted. Allowing for a follow-up loss rate of 10 %, the total sample size is expected as 28. For biomarker evaluation, the categorical groups were investigated to evaluated possible association with response and/or survival. Associations were analyzed by χ2 test or Fisher's exact test for categorical variables. The Kaplan-Meier method was used to analyze survival outcomes (EFS, OS, and DFS). To compare PD-L1 expression between paired pre- and post-neoadjuvant treatment with associated of pCR, the Wilcoxon signed-rank test was used.|||
71708451|NCT01887600|142934699|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|20.48|58.93|||Cochran-Mantel-Haenszel||Please note Odds Ratio and CI are shown in percentages.|The Cochran-Mantel-Haenszel (CMH) test was adjusted by region, history of of cardiovascular, cerebrovascular or thromboembolic (CV) disease, baseline Hb and baseline estimated glomerular filtration rate (eGFR). Superiority of roxadustat versus placebo was to be declared if the lower bound of the two-sided 95% confidence interval of the CMH odds ratio was higher than 1.||58.93|20.48|<0.001
71708452|NCT01887600|142934700|SUPERIORITY||Least squares mean difference|1.692|||<|0.001||95.0|1.52|1.86|||ANCOVA|||The Analysis of Covariance (ANCOVA) with Multiple Imputations (MI) model, adjusting for covariates was used for the analysis. The model included treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates. Superiority of roxadustat versus placebo was considered successful if the lower bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) was higher than 0.||1.86|1.52|<0.001
71708453|NCT01887600|142934701|SUPERIORITY||Least squares mean difference|1.599|||<|0.001|TWO_SIDED|95.0|1.41|1.78||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline Hb, baseline eGFR and baseline Hb by visit interaction as continuous covariates.||1.78|1.41|<0.001
71708454|NCT01887600|142934702|SUPERIORITY|Superiority of roxadustat versus placebo was considered successful if the upper bound of the two-sided 95% confidence interval of the difference between treatment arms (roxadustat minus placebo) is below 0.|Least squares mean difference|-0.701|||<|0.001||95.0|-0.83|-0.57||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects during the period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb, baseline eGFR and baseline LDL as continuous variables.||-0.57|-0.83|<0.001
71708455|NCT01887600|142934703|SUPERIORITY||Hazard Ratio (HR)|0.238|||<|0.001|TWO_SIDED|95.0|0.17|0.33||Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates. Superiority is declared if the upper bound of the 95% CI is below 1.0.||0.33|0.17|<0.001
71655173|NCT04295135|142828326|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.006|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
71655174|NCT04295135|142828327|SUPERIORITY||Median Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.001|<|0.01|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||<0.01
71886620|NCT02475655|143293561|SUPERIORITY||Mean Difference (Net)|4.9||||0.02|TWO_SIDED|90.0|1.46|8.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.||8.33|1.46|0.020
71886621|NCT02475655|143293561|SUPERIORITY||Mean Difference (Net)|11.0||||0.004|TWO_SIDED|90.0|4.84|17.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.||17.1|4.84|0.004
71708456|NCT01887600|142934704|SUPERIORITY||Least squares mean difference|1.127|||=|0.093|TWO_SIDED|95.0|-0.19|2.44||LSM Difference p-value is for test of differences.Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 VT, baseline Hb and baseline eGFR as continuous variables.||2.44|-0.19|=0.093
71708457|NCT01887600|142934705|SUPERIORITY||Least squares mean difference|0.713|||=|0.27|TWO_SIDED|95.0|-0.56|1.98||LSM Difference p-value is for test of differences. Tested using a fixed sequence testing procedure to maintain the overall two-sided type I error rate at 0.05.|Mixed Models Analysis|||A Mixed Model of Repeated Measures has been applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms and overall mean effects throughout the evaluation period (weeks 12 to 28). The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline SF-36 PF, baseline Hb and baseline eGFR as continuous variables.||1.98|-0.56|=0.27
71708458|NCT01887600|142934706|NON_INFERIORITY|Non-inferiority can be concluded if the upper bound of the two-sided 95% CI of the difference between roxadustat and placebo (roxadustat minus placebo) is below 2 mmHg.|Least squares mean difference|0.842|||=|0.182|TWO_SIDED|95.0|-0.4|2.08||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms with overall mean effects throughout the evaluation period (weeks 20 to 28). The model included treatment, visit, visit by treatment interaction, region and history of CV disease as fixed class factors and baseline MAP, baseline Hb, baseline eGFR as continuous covariates.||2.08|-0.40|=0.182
71708459|NCT01887600|142934707|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the 95% CI is below 1.3 (hazard ratio).|Hazard Ratio (HR)|1.29|||=|0.334|TWO_SIDED|95.0|0.77|2.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||2.16|0.77|=0.334
71708460|NCT01887600|142934708|SUPERIORITY||Least squares mean difference|0.59|||=|0.316|TWO_SIDED|95.0|-0.57|1.75|||Mixed Models Analysis|||Annualized eGFR slope over time was estimated by a random slopes and intercepts model using all available eGFR values adjusted on baseline Hb, region, CV history at Baseline and the interaction terms.||1.75|-0.57|=0.316
71708461|NCT01887600|142934709|SUPERIORITY||Least squares mean difference|1.638|||<|0.001|TWO_SIDED|95.0|1.44|1.84||LSM Difference p-value is for test of differences|Mixed Models Analysis|||Average Level of Hb Over Weeks 28 to 36. A Mixed Model of Repeated Measures was applied using the visits over weeks 28 to 36. The results were based on the estimated difference between the two treatment arms by visit based on this MMRM model. The model included treatment arm, region, CV History, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.84|1.44|<0.001
71708462|NCT01887600|142934710|SUPERIORITY||Least squares mean difference|1.604|||<|0.001|TWO_SIDED|95.0|1.39|1.82||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 44 to 52. A Mixed Model of Repeated Measures was applied using the visits over weeks 44 to 52. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.39|<0.001
71708463|NCT01887600|142934711|SUPERIORITY||Least squares mean difference|1.492|||<|0.001|TWO_SIDED|95.0|1.14|1.85||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Average Level of Hb Over Weeks 96 to 104. A Mixed Model of Repeated Measures was applied using the visits over weeks 96 to 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.85|1.14|<0.001
71708464|NCT01887600|142934712|SUPERIORITY||Hazard Ratio (HR)|19.001|||<|0.001|TWO_SIDED|95.0|11.98|30.15|||Regression, Cox|||Time to Achieve the First Hb Response. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||30.15|11.98|<0.001
71765182|NCT01578850|143032744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.048|TWO_SIDED|95.0|-1.0|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-0.01|-1.00|0.048
71708465|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|0.396|||<|0.001|TWO_SIDED|95.0|0.29|0.5||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 1. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||0.50|0.29|<0.001
71708466|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|0.938|||<|0.001|TWO_SIDED|95.0|0.81|1.07||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 2. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.07|0.81|<0.001
71708467|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.471|||<|0.001|TWO_SIDED|95.0|1.3|1.64||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 4. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.64|1.30|<0.001
71765183|NCT01578850|143032744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.001|TWO_SIDED|95.0|-1.44|-0.43|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-0.43|-1.44|<0.001
71765184|NCT01578850|143032744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.33|-0.33|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-0.33|-1.33|0.001
71765185|NCT01578850|143032744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-0.31|-1.33|0.002
71765186|NCT01578850|143032746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.11||||0.033|TWO_SIDED|95.0|-27.07|-1.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 28||-1.16|-27.07|0.033
71765187|NCT01578850|143032746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04||||0.013|TWO_SIDED|95.0|-30.39|-3.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 36||-3.68|-30.39|0.013
71765188|NCT01578850|143032746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.54||||0.019|TWO_SIDED|95.0|-30.35|-2.73|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 44||-2.73|-30.35|0.019
71765189|NCT01578850|143032746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.66||||0.007|TWO_SIDED|95.0|-33.78|-5.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Week 52||-5.54|-33.78|0.007
71826488|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|1.02|1.21|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used.||Anti-HPV Type 6||1.21|1.02|<0.001
71765190|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.21||||0.078|TWO_SIDED|95.0|-8.91|0.48|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 28||0.48|-8.91|0.078
71765191|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.54||||0.003|TWO_SIDED|95.0|-12.49|-2.59|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 36||-2.59|-12.49|0.003
71765192|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.19||||0.001|TWO_SIDED|95.0|-13.2|-3.18|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 44||-3.18|-13.20|0.001
71765193|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.001|TWO_SIDED|95.0|-13.64|-3.55|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||General Health VAS: Week 52||-3.55|-13.64|<0.001
71765194|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91||||0.017|TWO_SIDED|95.0|-10.75|-1.06|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 28||-1.06|-10.75|0.017
71765195|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.001|TWO_SIDED|95.0|-13.85|-3.34|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 36||-3.34|-13.85|0.001
71765196|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.49|||<|0.001|TWO_SIDED|95.0|-14.72|-4.26|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 44||-4.26|-14.72|<0.001
71765197|NCT01578850|143032748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-14.6|-3.99|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||Pain VAS: Week 52||-3.99|-14.60|<0.001
71765198|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.22||||0.014|TWO_SIDED|95.0|-9.39|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 28||-1.05|-9.39|0.014
71886622|NCT02475655|143293561|SUPERIORITY||Mean Difference (Net)|4.64||||0.043|TWO_SIDED|90.0|0.88|8.39||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.||8.39|0.88|0.043
71886623|NCT02475655|143293562|SUPERIORITY||Mean Difference (Net)|1.1||||0.56|TWO_SIDED|90.0|0.84|1.44||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.||1.44|0.84|0.56
71886624|NCT02475655|143293562|SUPERIORITY||Mean Difference (Net)|1.37||||0.026|TWO_SIDED|90.0|1.09|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.||1.73|1.09|0.026
71886625|NCT02475655|143293563|SUPERIORITY||Mean Difference (Net)|0.89||||0.07|TWO_SIDED|90.0|0.8|0.99||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.||0.99|0.80|0.07
71886626|NCT02475655|143293563|SUPERIORITY||Mean Difference (Net)|0.95||||0.59|TWO_SIDED|90.0|0.8|1.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.||1.12|0.80|0.59
71886627|NCT02475655|143293563|SUPERIORITY||Mean Difference (Net)|1.06||||0.56|TWO_SIDED|90.0|0.9|1.24||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.||1.24|0.90|0.56
71886628|NCT02475655|143293564|SUPERIORITY||Mean Difference (Net)|142.1||||0.007|TWO_SIDED|90.0|57.6|227.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.||227|57.6|0.007
71886629|NCT02475655|143293564|SUPERIORITY||Mean Difference (Net)|74.3||||0.14|TWO_SIDED|90.0|-8.23|156.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.||156.7|-8.23|0.14
71886630|NCT02475655|143293564|SUPERIORITY||Mean Difference (Net)|-38.9||||0.54|TWO_SIDED|90.0|-143.0|65.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.||65.5|-143|0.54
71886631|NCT02475655|143293564|SUPERIORITY||Mean Difference (Net)|-112.0||||0.12|TWO_SIDED|90.0|-231.0|5.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.||5.90|-231|0.12
71886632|NCT02475655|143293566|SUPERIORITY||Risk Ratio (RR)|0.98||||0.94|TWO_SIDED|90.0|0.65|1.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.||1.49|0.65|0.94
71886633|NCT02475655|143293566|SUPERIORITY||Risk Ratio (RR)|0.74||||0.46|TWO_SIDED|90.0|0.37|1.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.||1.46|0.37|0.46
71708468|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.827|||<|0.001|TWO_SIDED|95.0|1.64|2.02||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 6. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.02|1.64|<0.001
71886634|NCT02475655|143293566|SUPERIORITY||Risk Ratio (RR)|0.83||||0.59|TWO_SIDED|90.0|0.46|1.48||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.||1.48|0.46|0.59
71886635|NCT02475655|143293567|SUPERIORITY||Mean Difference (Net)|0.88||||0.11|TWO_SIDED|90.0|0.76|1.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 5.||1.01|0.76|0.11
71886636|NCT02475655|143293567|SUPERIORITY||Mean Difference (Net)|0.92||||0.71|TWO_SIDED|90.0|0.64|1.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 12.||1.33|0.64|0.71
71886637|NCT02475655|143293568|SUPERIORITY||Mean Difference (Net)|1.27||||0.3|TWO_SIDED|90.0|0.87|1.86||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 5.||1.86|0.87|0.30
71886638|NCT02475655|143293568|SUPERIORITY||Mean Difference (Net)|1.59||||0.46|TWO_SIDED|90.0|0.56|4.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 12.||4.49|0.56|0.46
71886639|NCT02475655|143293569|SUPERIORITY||Mean Difference (Net)|1.29||||0.24|TWO_SIDED|90.0|0.9|1.84||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 5.||1.84|0.90|0.24
71765199|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27||||0.011|TWO_SIDED|95.0|-11.09|-1.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 36||-1.46|-11.09|0.011
71765200|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-12.06|-3.44|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 44||-3.44|-12.06|<0.001
71765201|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16||||0.001|TWO_SIDED|95.0|-11.48|-2.85|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||CRP: Week 52||-2.85|-11.48|0.001
71886640|NCT02475655|143293569|SUPERIORITY||Mean Difference (Net)|1.19||||0.46|TWO_SIDED|90.0|0.81|1.74||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 12.||1.74|0.81|0.46
71886641|NCT02475655|143293574|SUPERIORITY||Mean Difference (Net)|1.15||||0.56|TWO_SIDED|90.0|0.77|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 5.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|1.72|0.77|0.56
71886642|NCT02475655|143293574|SUPERIORITY||Mean Difference (Net)|0.97||||0.95|TWO_SIDED|90.0|0.47|2.01||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 12.||2.01|0.47|0.95
71886643|NCT02475655|143293575|SUPERIORITY||Mean Difference (Net)|1.34||||0.002|TWO_SIDED|90.0|1.15|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 5.||1.56|1.15|0.002
71765202|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.86|||<|0.001|TWO_SIDED|95.0|-9.23|-2.49|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 28||-2.49|-9.23|<0.001
71765203|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.69|||<|0.001|TWO_SIDED|95.0|-12.33|-5.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 36||-5.05|-12.33|<0.001
71765204|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|||<|0.001|TWO_SIDED|95.0|-11.38|-3.8|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 44||-3.80|-11.38|<0.001
71765205|NCT01578850|143032750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.32|||<|0.001|TWO_SIDED|95.0|-10.03|-2.6|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR\<2.6 or Stratum 2=LDA: 2.6\<=DAS28-ESR\<3.2).||ESR: Week 52||-2.60|-10.03|<0.001
71765206|NCT01008423|143032751|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||<0.0001
71765207|NCT00934843|143032789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.35|TWO_SIDED|95.0|0.45|1.33|||Multivariate risk computation|||The current study was designed with an anticipated enrollment of 87 patients per treatment arm to achieve a statistical power of 80% (1- β) while controlling type I error at 0.05 (α) using a more conservative estimate of LCOS rate in the Single Dose MP group of 33%, and an incidence of LCOS in the Two Dose MP group of 15%.||1.33|0.45|0.35
71765208|NCT00934843|143032790|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||A repeated measures analysis of variance framework was used for longitudinal analysis of inotrope score. In order to identify potential confounding variables, a variable was considered a relevant covariate and added into the model with a p ≤ 0.15.|ANCOVA|||||||0.43
71765209|NCT00934843|143032792|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|ANCOVA|||||||0.052
71765210|NCT00934843|143032793|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.||||||0.047
71765211|NCT03456882|143032794|SUPERIORITY|||||||0.6346||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.6346
71826489|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|1.0|1.19|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 11||1.19|1.00|<0.001
71826490|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 16||1.30|1.10|<0.001
71826491|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.08|1.31|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 18||1.31|1.08|<0.001
71826492|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.13|1.37|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 31||1.37|1.13|<0.001
71826493|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 33||1.30|1.10|<0.001
71826494|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.27|||<|0.001|TWO_SIDED|95.0|1.14|1.41|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 45||1.41|1.14|<0.001
71765212|NCT03456882|143032794|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3585|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3585
71765213|NCT03456882|143032795|SUPERIORITY|||||||0.4388||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.4388
71765214|NCT03456882|143032795|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|20.2||0.9887|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.9887
71765215|NCT03456882|143032796|SUPERIORITY|||||||0.9622||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9622
71826495|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.05|1.26|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 52||1.26|1.05|<0.001
71886644|NCT02475655|143293575|SUPERIORITY||Mean Difference (Net)|1.07||||0.6|TWO_SIDED|90.0|0.86|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 12.||1.34|0.86|0.60
71708469|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|2.058|||<|0.001|TWO_SIDED|95.0|1.87|2.25||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 8. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.25|1.87|<0.001
71708470|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.949|||<|0.001|TWO_SIDED|95.0|1.75|2.14||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 10. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.14|1.75|<0.001
71708471|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.9|2.28||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 12. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.28|1.90|<0.001
71708472|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|2.051|||<|0.001|TWO_SIDED|95.0|1.86|2.24||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 14. A Mixed Model of Repeated Measures was applied using the visits up to Week 104. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.24|1.86|<0.001
71708473|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.987|||<|0.001|TWO_SIDED|95.0|1.79|2.19||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 16. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.19|1.79|<0.001
71708474|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.841|||<|0.001|TWO_SIDED|95.0|1.64|2.05||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 18. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.05|1.64|<0.001
71708475|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.824|||<|0.001|TWO_SIDED|95.0|1.61|2.04||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 20. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||2.04|1.61|<0.001
71708476|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.651|||<|0.001|TWO_SIDED|95.0|1.43|1.87||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 22. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.87|1.43|<0.001
71708477|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.447|||<|0.001|TWO_SIDED|95.0|1.23|1.67||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 24. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.67|1.23|<0.001
71708478|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.561|||<|0.001|TWO_SIDED|95.0|1.34|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 28. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.34|<0.001
71708479|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.587|||<|0.001|TWO_SIDED|95.0|1.37|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 32. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.37|<0.001
71708480|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.46|1.92||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb Change from BL to week 36. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.92|1.46|<0.001
71886645|NCT02475655|143293576|SUPERIORITY||Mean Difference (Net)|0.94||||0.4|TWO_SIDED|90.0|0.82|1.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 5.||1.07|0.82|0.40
71886646|NCT02475655|143293576|SUPERIORITY||Mean Difference (Net)|1.03||||0.82|TWO_SIDED|90.0|0.83|1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 12.||1.27|0.83|0.82
71886647|NCT02475655|143293577|SUPERIORITY||Mean Difference (Net)|1.5||||0.028|TWO_SIDED|90.0|1.11|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 5.||2.02|1.11|0.028
71886648|NCT02475655|143293577|SUPERIORITY||Mean Difference (Net)|2.04||||0.21|TWO_SIDED|90.0|0.79|5.25||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 12.||5.25|0.79|0.21
71886649|NCT02475655|143293578|SUPERIORITY||Mean Difference (Net)|1.39||||0.031|TWO_SIDED|90.0|1.08|1.79||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 5.||1.79|1.08|0.031
71886650|NCT02475655|143293578|SUPERIORITY||Mean Difference (Net)|0.96||||0.93|TWO_SIDED|90.0|0.46|2.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 12.||2.02|0.46|0.93
71886651|NCT02475655|143293579|SUPERIORITY||Mean Difference (Net)|1.57||||0.43|TWO_SIDED|90.0|0.61|4.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 5.||4.05|0.61|0.43
71886652|NCT02475655|143293579|SUPERIORITY||Mean Difference (Net)|0.68||||0.41|TWO_SIDED|90.0|0.3|1.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 12.||1.50|0.30|0.41
71886653|NCT02475655|143293580|SUPERIORITY||Mean Difference (Net)|-0.34||||0.038|TWO_SIDED|90.0|-0.61|-0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 5.||-0.07|-0.61|0.038
71886654|NCT02475655|143293580|SUPERIORITY||Mean Difference (Net)|0.27||||0.07|TWO_SIDED|90.0|0.03|0.51||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 12.||0.51|0.03|0.07
71708481|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.645|||<|0.001|TWO_SIDED|95.0|1.41|1.88||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 40. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.88|1.41|<0.001
71708482|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.699|||<|0.001|TWO_SIDED|95.0|1.45|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 44. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.45|<0.001
71708483|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.446|||<|0.001|TWO_SIDED|95.0|1.2|1.69||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 48. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.69|1.20|<0.001
71826496|NCT01651949|143157902|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was \>0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.14|1.36|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 58||1.36|1.14|<0.001
71826497|NCT01651949|143157903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.5|||<|0.001|TWO_SIDED|95.0|-15.0|-8.0|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Erythema||-8.0|-15.0|<0.001
71826498|NCT01651949|143157903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-19.1|||<|0.001|TWO_SIDED|95.0|-22.5|-15.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Pain||-15.7|-22.5|<0.001
71826499|NCT01651949|143157903|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-17.3|||<|0.001|TWO_SIDED|95.0|-20.8|-13.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Swelling||-13.7|-20.8|<0.001
71826500|NCT01651949|143157904|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.5||||0.091|TWO_SIDED|95.0|-3.4|0.2|||Miettinen & Nurminen||The incidence of maximum body temperature \>=37.8° C reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Elevated Body Temperature||0.2|-3.4|0.091
71886655|NCT02475655|143293581|SUPERIORITY||Mean Difference (Net)|-0.88||||0.05|TWO_SIDED|90.0|-1.62|-0.13||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-0.13|-1.62|0.05
71708484|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.641|||<|0.001|TWO_SIDED|95.0|1.39|1.89||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 52. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.89|1.39|<0.001
71708485|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.37|1.91||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 56. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit.The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.91|1.37|<0.001
71886656|NCT02475655|143293581|SUPERIORITY||Mean Difference (Net)|0.86||||0.16|TWO_SIDED|90.0|-0.16|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||1.88|-0.16|0.16
71886657|NCT02475655|143293582|SUPERIORITY||Mean Difference (Net)|-1.71|||<|0.001|TWO_SIDED|90.0|-2.46|-0.97||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 5.||-0.97|-2.46|<0.001
71886658|NCT02475655|143293582|SUPERIORITY||Mean Difference (Net)|0.16||||0.68|TWO_SIDED|90.0|-0.5|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 12.||0.82|-0.50|0.68
71708486|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.634|||<|0.001|TWO_SIDED|95.0|1.33|1.94||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 60. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.94|1.33|<0.001
71708487|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.404|||<|0.001|TWO_SIDED|95.0|1.08|1.73||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 64. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.73|1.08|<0.001
71708488|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.499|||<|0.001|TWO_SIDED|95.0|1.18|1.82||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change From BL to week 68. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.82|1.18|<0.001
71708489|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.438|||<|0.001|TWO_SIDED|95.0|1.1|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 72. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.10|<0.001
71708490|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.185|||<|0.001|TWO_SIDED|95.0|0.83|1.54||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 76. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.54|0.83|<0.001
71826501|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|0.9|||Miettinen & Nurminen|||Anti-HPV Type 6||0.9|-0.7|<0.001
71826502|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.8|||Miettinen & Nurminen|||Anti-HPV Type 11||0.8|-0.3|<0.001
71826503|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 16||0.7|-0.3|<0.001
71826504|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.4|0.8|||Miettinen & Nurminen|||Anti-HPV Type 18||0.8|-0.4|<0.001
71826505|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-0.4|0.5|||Miettinen & Nurminen|||Anti-HPV Type 31||0.5|-0.4|<0.001
71708491|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.443|||<|0.001|TWO_SIDED|95.0|1.11|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 80. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|1.11|<0.001
71708492|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.374|||<|0.001|TWO_SIDED|95.0|0.99|1.75||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 84. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.75|0.99|<0.001
71708493|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.171|||<|0.001|TWO_SIDED|95.0|0.79|1.55||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 88. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.55|0.79|<0.001
71708494|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.382|||<|0.001|TWO_SIDED|95.0|0.98|1.78||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 92. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.78|0.98|<0.001
71708495|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.563|||<|0.001|TWO_SIDED|95.0|1.15|1.97||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 96. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.97|1.15|<0.001
71708496|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.448|||<|0.001|TWO_SIDED|95.0|1.06|1.83||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 100. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.83|1.06|<0.001
71708497|NCT01887600|142934713|SUPERIORITY||Least squares mean difference|1.347|||<|0.001|TWO_SIDED|95.0|0.9|1.79||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Hb change from BL to week 104. A Mixed Model of Repeated Measures was applied. The results were based on the estimated difference between the two treatment arms by visit. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.79|0.90|<0.001
71708498|NCT01887600|142934714|SUPERIORITY||Least squares mean difference|1.614|||<|0.001|TWO_SIDED|95.0|1.42|1.81||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 28-36. A Mixed Model of Repeated Measures was applied using the visits up to week 36. The results were based on the estimated difference between the two treatment arms overall mean effect during week 28 to 36 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.42|<0.001
71708499|NCT01887600|142934715|SUPERIORITY||Least squares mean difference|1.594|||<|0.001|TWO_SIDED|95.0|1.38|1.81||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||Change from baseline to average Hb weeks 44-52. A Mixed Model of Repeated Measures was applied using the visits up to week 52. The results were based on the estimated difference between the two treatment arms overall mean effect during week 44 to 52 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.81|1.38|<0.001
71765216|NCT03456882|143032796|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|14.3||0.6533|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.6533
71826506|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 33||0.7|-0.3|<0.001
71708500|NCT01887600|142934716|SUPERIORITY||Least squares mean difference|1.452|||<|0.001|TWO_SIDED|95.0|1.1|1.8||LSM difference p-value is for test of differences.|Mixed Models Analysis|||Change from BL to average Hb weeks 96-104. A Mixed Model of Repeated Measures was applied using the visits up to week 104. The results were based on the estimated difference between the two treatment arms overall mean effect during week 96 to 104 period based on this MMRM model. The model included treatment arm, region, CV history, visits and visit by treatment as categorical variables and baseline Hb and baseline eGFR as continuous variables.||1.80|1.10|<0.001
71708501|NCT01887600|142934720|SUPERIORITY||Hazard Ratio (HR)|0.945|||=|0.643|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.20|0.74|=0.643
71708502|NCT01887600|142934722|SUPERIORITY||Hazard Ratio (HR)|0.139|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Regression, Cox|||Time to start rescue therapy within first 24 weeks. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.23|0.08|<0.001
71708503|NCT01887600|142934723|SUPERIORITY||Cox Proportional Hazard|0.343|||<|0.001|TWO_SIDED|95.0|0.21|0.55|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.55|0.21|<0.001
71708504|NCT01887600|142934724|SUPERIORITY||Least squares mean difference|-0.045|||=|0.128|TWO_SIDED|95.0|-0.1|0.01|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied including treatment as fixed factor, region and history of CV disease as class factors and baseline Hb, baseline eGFR as continuous covariates.||0.01|-0.10|=0.128
71826507|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|1.0|||Miettinen & Nurminen|||Anti-HPV Type 45||1.0|-0.4|<0.001
71826508|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 52||0.9|-0.2|<0.001
71886659|NCT02475655|143293583|SUPERIORITY||Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|90.0|-0.7|0.69||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 5.||0.69|-0.70|0.98
71826509|NCT01651949|143157905|NON_INFERIORITY_OR_EQUIVALENCE|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 58||0.9|-0.2|<0.001
71708505|NCT01887600|142934725|SUPERIORITY||Least squares mean difference|-10.429|||=|0.183|TWO_SIDED|95.0|-25.81|4.95|||ANCOVA|||The Analysis of Covariance (ANCOVA) model was applied included treatment arm, region, CV history as categorical variables and baseline Hb and baseline eGFR as continuous variables.||4.95|-25.81|=0.183
71708506|NCT01887600|142934726|SUPERIORITY||Hazard Ratio (HR)|0.101|||<|0.001|TWO_SIDED|95.0|0.06|0.17|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.17|0.06|<0.001
71708507|NCT01887600|142934727|SUPERIORITY||Hazard Ratio (HR)|0.538|||=|0.045|TWO_SIDED|95.0|0.29|0.99|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||0.99|0.29|=0.045
71826510|NCT01806714|143157908|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3|||<|0.04|TWO_SIDED|95.0|1.0|1.6|||clustered stratified Proportional Hazard||We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.|||1.6|1.0|<0.04
71886660|NCT02475655|143293583|SUPERIORITY||Mean Difference (Net)|-0.16||||0.79|TWO_SIDED|90.0|-1.13|0.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 12.||0.82|-1.13|0.79
71708508|NCT01887600|142934736|SUPERIORITY||Least squares mean difference|0.374|||=|0.475|TWO_SIDED|95.0|-0.65|1.4||LSM Difference p-value is for test of differences.|Mixed Models Analysis|||The Mixed Model of Repeated Measures included treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, baseline eGFR as continuous covariates.||1.40|-0.65|=0.475
71708509|NCT01887600|142934737|SUPERIORITY||Least squares mean difference|1.704|||=|0.047|TWO_SIDED|95.0|0.02|3.38||LSM difference p-value is for test of differences|Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The model includes treatment, visit (week 8, week 12 and week 28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, baseline eGFR as continuous covariates. Baseline FACT-An Ans is defined as the FACT-An Ans value on day 1.||3.38|0.02|=0.047
71765217|NCT03456882|143032797|SUPERIORITY|||||||0.9137||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.9137
71765218|NCT03456882|143032797|SUPERIORITY||Mean Difference (Net)|16.7|STANDARD_ERROR_OF_MEAN|19.7||0.3985|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.3985
71886661|NCT02475655|143293584|SUPERIORITY||Mean Difference (Net)|3.49||||0.001|TWO_SIDED|90.0|1.75|5.22||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 5.||5.22|1.75|0.001
71708510|NCT01887600|142934738|SUPERIORITY||Least squares mean difference|2.086|||=|0.225|TWO_SIDED|95.0|-1.29|5.46|||Mixed Models Analysis|||A Mixed Model of Repeated Measures was applied using the visits up to week 28. The results were based on the estimated difference between the two treatment arms overall mean effect during week 12 to 28 period based on this MMRM model.The model includes treatment, visit (week8, week12 and week28), visit by treatment interaction, region and history of CV disease as fixed class factors and baseline FACT-An Total Score, baseline Hb, baseline eGFR as continuous covariates.||5.46|-1.29|=0.225
71708511|NCT01887600|142934749|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.973|TWO_SIDED|95.0|0.75|1.32|||Regression, Cox|||Time to doubling of serum Creatinine. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.32|0.75|=0.973
71708512|NCT01887600|142934750|SUPERIORITY||Hazard Ratio (HR)|0.995|||=|0.972|TWO_SIDED|95.0|0.76|1.3|||Regression, Cox|||Time to CKD progression. Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.30|0.76|=0.972
71708513|NCT01887600|142934751|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.439|TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||Hazard ratio was calculated using stratified Cox Proportional Hazards Regression stratifying on CV history and region and adjusting on Hb and eGFR at baseline as continuous covariates.||1.16|0.70|=0.439
71708514|NCT03688139|142934752|SUPERIORITY||difference in slopes|0.23||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
71708515|NCT03688139|142934752|OTHER|This analysis tested whether the course of LPP was associated with the course of BADS over the 9-week treatment period in the Engage group.|Slope|0.03||||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||.14
71708516|NCT03688139|142934753|SUPERIORITY||difference in slopes|-0.06||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
71708517|NCT03688139|142934754|SUPERIORITY||difference in slopes|-0.03||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||.69
71708518|NCT03688139|142934755|SUPERIORITY||difference in slopes|-0.45||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||.39
71708519|NCT03688139|142934756|OTHER|This analysis tested the hypothesis that change in LPP for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|-0.1||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||.58
71708520|NCT03688139|142934756|OTHER|This analysis tested the hypothesis that change in SHAPS for each assessment interval would predict severity of anhedonia at the next assessment in Engage but not in Supportive Therapy.|difference in slopes|0.0||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||.96
71708521|NCT02470377|142934757|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0439||||||Only p-values \<0.05 were considered significant|ANOVA|One way ANOVA, immediate DHI changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0439
71708522|NCT02470377|142934758|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.0316|||||||ANOVA|One way ANOVA, immediate MBRS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.0316
71765219|NCT03456882|143032798|SUPERIORITY|||||||0.2543||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2543
71886662|NCT02475655|143293584|SUPERIORITY||Mean Difference (Net)|-1.3||||0.28|TWO_SIDED|90.0|-3.28|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 12.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|0.68|-3.28|0.28
71708523|NCT02470377|142934759|SUPERIORITY|The hypothesis was that either Target 1 (Occipital) or Target 2 (Vermis) would be more effective than the control target (Cerebellar hemisphere) but that there may be baseline differences in participants who chose Target 1 vs Target 2.||||||0.1754|||||||ANOVA|One way ANOVA, immediate HADS changes used for calculation.||This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.||||0.1754
71708524|NCT00655356|142934780|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
71708525|NCT00655356|142934781|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.0075
71708526|NCT02496156|142934784|SUPERIORITY||||||<|0.39||||||This is a computed p-value.|Mixed Models Analysis|||Missing data treatment was done using multiple imputation methods when data were determined to be Missing Completely at Random or Missing at Random. Assumptions underlying each statistical test were evaluated before proceeding with specific analyses.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||<0.39
71708527|NCT02496156|142934785|SUPERIORITY||||||>|0.05||||||Computed p-value exceeded the .05 level of significance.|Mixed Models Analysis||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
71708528|NCT02496156|142934786|SUPERIORITY||||||>|0.05||||||This is a computed p-value.|Mixed Models Analysis|||See description of analysis below.|For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
71708529|NCT02496156|142934787|SUPERIORITY||||||>|0.05||||||Computed p-value|ANCOVA|Difference in post-test scores with baseline Knowledge test score as the covariate.||||||>0.05
71708530|NCT02496156|142934789|SUPERIORITY|See analysis description below.|||||>|0.05||||||Computed p-value|ANOVA||||For each outcome, a linear mixed effects model was fit; with the exception of the Knowledge test where a linear model was fit. Separate models were fit for Parents and adolescents except for HbA1C. The predictor variable is treatment group (SMDM vs. UCP). Covariates are gender, age, social economic status, and family structure as determined by (number of siblings and of caregivers in the home). A random intercept was fit for each subject across the longitudinal data. To accommodate missing values multiple imputation methodology was applied to the data, resulting in five imputed datasets. For each imputed dataset, a linear mixed effects model (or linear model for Knowledge Test) was fit; the resulting five models were pooled into a final model and summary statistics are presented. A two-sided Wald's t test determined significance of covariates. The significance level was 0.05. Appropriate model diagnostics were performed to assess model fit.|||>0.05
71708531|NCT04349098|142934800|SUPERIORITY||Odds Ratio (OR)|0.84||||0.675|TWO_SIDED|95.0|0.39|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.39|0.6750
71708532|NCT01703221|142934813|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-0.96|-0.63|||Constrained longitudinal analysis|Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.63|-0.96|<0.001
71765220|NCT03456882|143032798|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.22||0.2209|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.2209
71708533|NCT01703221|142934813|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-0.78|||<|0.001|TWO_SIDED|95.0|-0.94|-0.61|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-0.61|-0.94|<0.001
71765221|NCT03456882|143032799|SUPERIORITY|||||||0.2738||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.2738
71765222|NCT03456882|143032799|SUPERIORITY||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|3.7||0.4239|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4239
71826511|NCT04897737|143157935|SUPERIORITY||Risk Ratio (RR)|1.83|||<|0.001|TWO_SIDED|95.0|1.19|2.82|||Mixed Models Analysis|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and risk differences (RDs) with 95% CIs.||2.82|1.19|<0.001
71708534|NCT01703221|142934813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).|Difference in the least squares means|-0.02||||0.792|TWO_SIDED|95.0|-0.15|0.12|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||0.12|-0.15|0.792
71708535|NCT01703221|142934818|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-36.89|||<|0.001|TWO_SIDED|95.0|-48.46|-25.33|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-25.33|-48.46|<0.001
71708536|NCT01703221|142934818|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-39.76|||<|0.001|TWO_SIDED|95.0|-51.28|-28.23|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-28.23|-51.28|<0.001
71708537|NCT01703221|142934818|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.86||||0.555|TWO_SIDED|95.0|-6.67|12.39|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||12.39|-6.67|0.555
71708538|NCT01703221|142934819|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-12.28|||<|0.001|TWO_SIDED|95.0|-17.78|-6.78|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-6.78|-17.78|<0.001
71708539|NCT01703221|142934819|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|-14.51|||<|0.001|TWO_SIDED|95.0|-20.04|-8.98|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||-8.98|-20.04|<0.001
71708540|NCT01703221|142934819|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares means|2.23||||0.33|TWO_SIDED|95.0|-2.27|6.73|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.||||6.73|-2.27|0.330
71708541|NCT05486065|142934820|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.25|-0.39|||ANCOVA|||||-0.39|-1.25|0.0002
71765223|NCT03456882|143032800|SUPERIORITY|||||||0.1708||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.1708
71708542|NCT05486065|142934820|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.77||||0.0003|TWO_SIDED|95.0|-1.19|-0.35|||ANCOVA|||||-0.35|-1.19|0.0003
71708543|NCT05486065|142934820|SUPERIORITY|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.64|||ANCOVA|||||-0.64|-1.50|<.0001
71708544|NCT05486065|142934820|OTHER||Treatment difference|0.05||||0.8305|TWO_SIDED|95.0|-0.38|0.47|||ANCOVA|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.||0.47|-0.38|0.8305
71708545|NCT05486065|142934820|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.3||||0.1678|TWO_SIDED|95.0|-0.72|0.13|||ANCOVA|||||0.13|-0.72|0.1678
71708546|NCT05486065|142934820|OTHER|The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor, sex as fixed effect and baseline HbA1c as a covariate. Missing values were imputed using Jump to reference method.|Treatment difference|-0.25||||0.2445|TWO_SIDED|95.0|-0.67|0.17|||ANCOVA|||||0.17|-0.67|0.2445
71708547|NCT00834587|142934860|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|92.4|106.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.2|92.4|
71708548|NCT00834587|142934861|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.7||||||90.0|98.8|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.6|98.8|
71708549|NCT00834587|142934862|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.6||||||90.0|98.8|102.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.5|98.8|
71708550|NCT00834587|142934863|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.7||||||90.0|97.3|106.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.3|97.3|
71708551|NCT00834587|142934864|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.2||||||90.0|96.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.0|96.5|
71708552|NCT00834587|142934865|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|96.5|101.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.8|96.5|
71708553|NCT03449147|142934908|SUPERIORITY||Estimated Relative Reduction (%)|-1.14||||0.875|TWO_SIDED|95.0|-14.27|14.02||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||14.02|-14.27|0.875
71708554|NCT03449147|142934908|SUPERIORITY||Estimated Relative Reduction (%)|-14.64||||0.031|TWO_SIDED|95.0|-26.07|-1.43||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-1.43|-26.07|0.031
71708555|NCT03449147|142934911|SUPERIORITY||Estimated Relative Reduction (%)|-3.03||||0.677|TWO_SIDED|95.0|-16.14|12.12||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||12.12|-16.14|0.677
71708556|NCT03449147|142934911|SUPERIORITY||Estimated Relative Reduction (%)|-15.79||||0.022|TWO_SIDED|95.0|-27.27|-2.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||ERR relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.||-2.50|-27.27|0.022
71708557|NCT03449147|142934912|SUPERIORITY||Odds Ratio (OR)|1.34||||0.077|TWO_SIDED|95.0|0.97|1.85||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.85|0.97|0.077
71708558|NCT03449147|142934912|SUPERIORITY||Odds Ratio (OR)|1.41||||0.04|TWO_SIDED|95.0|1.02|1.96||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||1.96|1.02|0.040
71708559|NCT03449147|142934913|SUPERIORITY||Odds Ratio (OR)|1.03||||0.872|TWO_SIDED|95.0|0.75|1.4||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.40|0.75|0.872
71765224|NCT03456882|143032800|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.25||0.8133|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.8133
71765225|NCT03456882|143032801|SUPERIORITY|||||||0.5239||||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.||Global test of treatment\*time interaction effect. Null hypothesis: the change over time is not different between groups.||||0.5239
71765226|NCT03456882|143032801|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4401|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 24 - baseline) within treatment groups. Null hypothesis: the change from baseline to week 24 is not different between treatment groups.||||0.4401
71765227|NCT03456882|143032802|SUPERIORITY||difference between mean slopes|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5725|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction||Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.5725
71765228|NCT03456882|143032802|SUPERIORITY||difference between mean slopes|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5728|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5728
71708560|NCT03449147|142934913|SUPERIORITY||Odds Ratio (OR)|1.33||||0.082|TWO_SIDED|95.0|0.96|1.83||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour as covariates.|Regression, Logistic|||||1.83|0.96|0.082
71708561|NCT03449147|142934914|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.96|1.83||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.83|0.96|
71708562|NCT03449147|142934914|OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.08|2.09||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.09|1.08|
71708563|NCT03449147|142934915|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.93|1.69||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||1.69|0.93|
71708564|NCT03449147|142934915|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.31|2.39||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.39|1.31|
71708565|NCT03449147|142934916|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.14|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.05|1.14|
71708566|NCT03449147|142934916|OTHER||Odds Ratio (OR)|1.65||||||95.0|1.23|2.22||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.||2.22|1.23|
71708567|NCT00993473|142935026|NON_INFERIORITY_OR_EQUIVALENCE|"Noninferiority would be demonstrated if the upper bound of the 95% confidence interval (CI) for the ratio of the rate of all hypoglycemia in the Lantus group to the rate in the NPH group was \<1.15. Superiority would be demonstrated if the upper bound of the 95% CI was \<1. The margin for noninferiority corresponded to one-half of the 30% difference in hypoglycemia event rate considered as a clinically significant difference by American Diabetes Association 2005 Working Group on Hypoglycemia."|Risk Ratio (RR)|1.18|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.97|1.44|||Generalized Linear Model|"A stepwise closed testing approach was used for the primary all hypoglycemia outcome analysis to assess noninferiority and superiority sequentially."|Risk ratio between treatment groups (Lantus/NPH) estimated by Generalized Linear Model with fixed effect terms for randomization strata and treatment.|"The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of all hypoglycemia of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment."||1.44|0.97|
71708568|NCT01537432|142935056|SUPERIORITY_OR_OTHER||difference in proportions|0.565|||<|0.001|TWO_SIDED|95.0|0.363|0.768|||Fisher Exact|||||0.768|0.363|<0.001
71708569|NCT03707821|142935058|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|3.3|STANDARD_DEVIATION|2.65|||TWO_SIDED|95.0|-2.0|8.5|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||8.5|-2.0|
71708570|NCT03707821|142935059|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 2 was used. This margin is based on a 10% difference if the proportion of subjects that report a higher rating/experience.|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.034|||TWO_SIDED|95.0|0.02|0.15|||Bayesian random -effects model|A 95% Credible Interval for the Posterior proportion mean difference between the Test and Control was used to test for non-inferiority.|mean difference was calculated as Test minus Control.|It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).||0.15|0.02|
71708571|NCT03707821|142935060|NON_INFERIORITY|A non-inferiority margin of 0.05 points was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-0.04|-0.01|||Bayesian Normal Random effects model|A 95% Credible Interval for the Posterior mean difference between the Test and control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||-0.01|-0.04|
71708572|NCT03707821|142935061|SUPERIORITY|A superiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|Mean Percentage of Acceptable Fitting|99.5|STANDARD_DEVIATION|0.38|||TWO_SIDED|95.0|98.5|100.0|||Bayesian Beta-Binomial Model|model for correlated data||It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100|98.5|
71765229|NCT03456882|143032803|SUPERIORITY|||||||0.9212||||||Significance level set to 0.05|Log Rank|||Null hypothesis: the survival curves over the on-treatment and the off-treatment follow-up period are not different between groups.||||0.9212
71708573|NCT03707821|142935062|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0036|||TWO_SIDED|95.0|-0.007|0.008|||Bayesian beta-binomial model|model for correlated data|mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.008|-0.007|
71708574|NCT03707821|142935063|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|2.5|STANDARD_DEVIATION|1.94|||TWO_SIDED|95.0|-1.3|6.3|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||6.3|-1.3|
71708575|NCT03707821|142935064|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|8.03|STANDARD_DEVIATION|2.295|||TWO_SIDED|95.0|3.48|12.54|||Bayesian normal random-effects|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.||12.54|3.48|
71708576|NCT03704922|142935065|OTHER|||||||0.051|||||||Fisher Exact|||||||0.051
71708577|NCT05122143|142935068|SUPERIORITY|||||||0.0085||||||Treatment D (A+B) versus Treatment C|ANCOVA|||"Treatment A + B were pooled to Treatment D for the Primary endpoint. The primary objective was to compare the efficacy of the AM-301 nasal spray (treatment D= A+B) and no treatment (C) in reducing nasal symptoms induced from HDM allergen exposure.~The TNSS value from the baseline exposure (at screening exposure visit 2) was subtracted from the TNSS value of the treatment exposure to obtain change from baseline. A lower value resembles less symptoms."||||0.0085
71708578|NCT03766906|142935070|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.003|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||.003
71708579|NCT03766906|142935071|SUPERIORITY||Mean Difference (Final Values)|1.18||||0.022|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than zero at P\<0.05.|||||.022
71708580|NCT03766906|142935072|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.016|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.016
71708581|NCT03766906|142935073|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.002|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.002
71708582|NCT03766906|142935074|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.626|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.626
71708583|NCT03766906|142935074|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.909|TWO_SIDED||||||t-test, 2 sided|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.||The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.909
71708584|NCT03766906|142935074|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.905|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|The statistical analyses for the Student Self-Efficacy, in terms of type of statistical test, method, and the comments which we state within-subjects paired t-tests, are the same for each of the three subscales that make up Student Self-Efficacy (i.e., Relevance to schoolwork, Future aspirations, and Family support).||||.905
71708585|NCT03766906|142935075|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.054|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||.054
71708586|NCT03766906|142935076|SUPERIORITY||Mean Difference (Final Values)|3.48|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
71708587|NCT03766906|142935077|SUPERIORITY||Mean Difference (Final Values)|7.52|||<|0.001|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.|Investigators tested whether pre-test to post-test change was significantly greater than 0 at P\<0.05.|||||<.001
71765230|NCT03456882|143032804|SUPERIORITY||difference between mean slopes|0.41|STANDARD_ERROR_OF_MEAN|0.16||0.0101|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the on-treatment period (change per week, from baseline to week 24) between treatment groups. Null hypothesis: the rate of change from baseline to week 24 is not different between groups.||||0.0101
71765231|NCT03456882|143032804|SUPERIORITY||difference between mean slopes|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.5924|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|Contrast of the slopes during the off-treatment follow-up period (change per week, from week 24 to week 48) between treatment groups. Null hypothesis: the rate of change from week 24 to week 48 is not different between groups.||||0.5924
71765232|NCT03456882|143032805|SUPERIORITY|||||||0.9598||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 4 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 4 weeks is not different between groups||||0.9598
71765233|NCT03456882|143032805|SUPERIORITY|||||||0.939||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 12 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 12 weeks is not different between groups||||0.9390
71708588|NCT01651208|142935109|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Chi-squared|||We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.||||<0.01
71708589|NCT01651208|142935110|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean MMAS-4 score is similar in both intervention arms||||<0.01
71708590|NCT00836901|142935111|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.7||||||90.0|93.19|102.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.43|93.19|
71708591|NCT00836901|142935112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.28||||||90.0|97.09|101.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.53|97.09|
71708592|NCT00836901|142935113|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.64||||||90.0|96.12|99.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.19|96.12|
71708593|NCT00836901|142935114|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.59||||||90.0|85.64|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||104.47|85.64|
71765234|NCT03456882|143032805|SUPERIORITY|||||||0.3442||||||Significance level set to 0.05|Fisher Exact|||AE treatment discontinuation 24 weeks. Null hypothesis: the percentage of patients experiencing at least one adverse event leading to treatment discontinuation within 24 weeks is not different between groups||||0.3442
71708594|NCT00836901|142935115|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.44||||||90.0|87.83|101.54|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.54|87.83|
71708595|NCT00836901|142935116|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.08||||||90.0|87.19|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.52|87.19|
71708596|NCT02732145|142935162|OTHER|"Question: Determination of sensitivity of the Vulvoscopy Index as a measure of the sensitivity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71708597|NCT02732145|142935162|OTHER|"Question: Determination of specificity of the Vulvoscopy index as a measure of the specificity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)"|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
71708598|NCT02732145|142935162|OTHER|"Question: Determination of diagnostic accuracy of the Vulvoscopy index as a measure of the diagnostic value of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)"|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
71708599|NCT02732145|142935162|SUPERIORITY|"Question: Determination of positive predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
71708600|NCT02732145|142935162|OTHER|"Question: Determination of negative predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71708601|NCT02732145|142935162|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the Vulvoscopy Index as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the Vulvoscopy Index and histopathology for detection of vulvar dermatosis."||||0.6108
71765235|NCT03456882|143032806|SUPERIORITY||difference between mean slopes|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1503|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 physical mobility. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1503
71708602|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708603|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9628|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9628
71708604|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9152|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9152
71708605|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708606|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with vulvar dermatosis diagnosed with vulvoscopy and histopathology?||||||0.8862|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8862
71708607|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708608|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3319|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3319
71708609|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8662|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8662
71708610|NCT02732145|142935163|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708611|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of vulvar complaints among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5399|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5399
71708612|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
71765236|NCT03456882|143032806|SUPERIORITY||difference between mean slopes|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.1556|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 ADL and independence.Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.1556
71708613|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
71708614|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of any lesion in any vulvar ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7537|||||||t|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7537
71765237|NCT03456882|143032806|SUPERIORITY||difference between mean slopes|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0319|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 eating and drinking. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.0319
71826512|NCT04897737|143157936|SUPERIORITY||Risk Ratio (RR)|3.89|||<|0.001|TWO_SIDED|95.0|2.08|7.27|||Regression, Linear|||All analyses were by intention-to-treat. In the case of missing outcomes for participants who did not return for the follow-up visit, we assigned outcome values of the following: poor PrEP adherence (TFV undetected) and partner not tested for HIV. We constructed univariate Poisson regression models with robust standard errors to examine the predictors of outcomes of interests. Model results are presented as crude risk ratios (RRs) and 95% CIs.|RD=49.1% (95% CI=32.8, 65.3), p\<0.001|7.27|2.08|<0.001
71708615|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2054|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2054
71826513|NCT01335932|143157946|OTHER|||||||0.0001|||||||Fisher Exact|||||||.0001
71708616|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6409|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6409
71708617|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
71708618|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8986|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8986
71708619|NCT02732145|142935164|SUPERIORITY|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0017|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0017
71708620|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708621|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (mean) among patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9899|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9899
71708622|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9686|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9686
71708623|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7055|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.7055
71708624|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8852|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8852
71708625|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708626|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3351|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3351
71708627|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
71708628|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8673
71826514|NCT01335932|143157947|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
71826515|NCT01335932|143157953|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
71826516|NCT01335932|143157954|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
71708629|NCT02732145|142935165|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (mean) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708630|NCT02732145|142935165|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8472|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8472
71708631|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708632|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9629|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9629
71708633|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9155|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9155
71708634|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.4913|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.4913
71708635|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8866|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8866
71708636|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708637|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3335|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3335
71708638|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
71708639|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8666
71708640|NCT02732145|142935167|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (median) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||1.0000
71708641|NCT02732145|142935167|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8144|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8144
71708642|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5403|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5403
71708643|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9248
71826517|NCT01335932|143157955|OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
71708644|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for the Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9839
71708645|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5124|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.5124
71826518|NCT01335932|143157956|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71826519|NCT01335932|143157957|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71826520|NCT01335932|143157958|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71708646|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2058|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.2058
71708647|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6412|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.6412
71708648|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.9753
71708649|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for the specificity of vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3621|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.3621
71886663|NCT02475655|143293585|SUPERIORITY||Mean Difference (Net)|6.54|||<|0.001|TWO_SIDED|90.0|3.76|9.31||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 5.||9.31|3.76|<0.001
71708650|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8987|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.||||0.8987
71708651|NCT02732145|142935168|EQUIVALENCE|Question: Is there a difference in the score for specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar lesions specific for dermatosis (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).||||0.0018
71708652|NCT02732145|142935168|EQUIVALENCE|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.4409|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.4409
71708653|NCT02732145|142935169|OTHER|"Question: Determination of sensitivity of the N-S-P Scheme as a measure of the sensitivity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"The Sensitivity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71708654|NCT02732145|142935169|OTHER|"Question: Determination of specificity of the N-S-P Scheme as a measure of the specificity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||TWO_SIDED|95.0|0.5794|1.0|||||"The Specificity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 - 1.0000)."|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.5794|
71708655|NCT02732145|142935169|OTHER|"Question: Determination of diagnostic accuracy of the N-S-P Scheme as a measure of the diagnostic value of the Three Rings Vulvoscopy, in relation to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||TWO_SIDED|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 - 1.0000)."|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.6313|
71708656|NCT02732145|142935169|OTHER|"Question: Determination of positive predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||TWO_SIDED|95.0|0.227|1.0|||||"Positive predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|0.2270|
71708657|NCT02732145|142935169|OTHER|"Question: Determination of negative predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||"Negative predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."||1.0000|1.0000|
71708658|NCT02732145|142935169|SUPERIORITY|"Question: Is there a difference in the diagnostic accuracy of the N-S-P Scheme as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the N-S-P Scheme and histopathology for detection of vulvar dermatosis."||||0.6108
71826521|NCT01335932|143157959|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71826522|NCT01335932|143157960|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71826523|NCT01335932|143157961|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
71826524|NCT01335932|143157962|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
71826525|NCT01335932|143157963|OTHER|||||||0.63|||||||t-test, 2 sided|||||||0.63
71826526|NCT01335932|143157964|OTHER|||||||0.51|||||||t-test, 2 sided|||||||0.51
71826527|NCT01335932|143157965|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
71826528|NCT01335932|143157966|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71826529|NCT01335932|143157967|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
71826530|NCT01335932|143157968|OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
71826531|NCT01335932|143157969|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
71826532|NCT01335932|143157970|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
71826533|NCT01335932|143157971|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
71708659|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9286|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9286
71708660|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8618|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8618
71708661|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9786|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9786
71708662|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
71708663|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8634|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8634
71708664|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7992|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7992
71708665|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.3912|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.3912
71765238|NCT03456882|143032806|SUPERIORITY||difference between mean slopes|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.6419|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 communication. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.6419
71765239|NCT03456882|143032806|SUPERIORITY||difference between mean slopes|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.3951|TWO_SIDED|||||Significance level set to 0.05|Mixed Models Analysis|Linear mixed model with random intercept,slope,unstructured variance covariance matrix.Independent variables:time,treatment,treatment\*time interaction|RNS60 vs. Placebo|ALSAQ-40 emotional reactions. Contrast of the slopes during the on-treatment and off-treatment follow-up period (change per week, from baseline to week 48) between treatment groups. Null hypothesis: the rate of change from baseline to week 48 is not different between groups.||||0.3951
71765240|NCT03456882|143032807|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|3.8||0.9563|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.9563
71765241|NCT03456882|143032808|SUPERIORITY||Mean Difference (Net)|28.5|STANDARD_ERROR_OF_MEAN|23.4||0.2253|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2253
71765242|NCT03456882|143032809|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|15.7||0.6263|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.6263
71765243|NCT03456882|143032810|SUPERIORITY||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|21.0||0.3671|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.3671
71826534|NCT01335932|143157972|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
71826535|NCT01335932|143157973|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
71826536|NCT01335932|143157974|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
71826537|NCT01335932|143157975|OTHER|||||||0.8|||||||t-test, 2 sided|||||||0.80
71826538|NCT01335932|143157976|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
71826539|NCT01335932|143157977|OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
71708666|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6152|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6152
71708667|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6108
71708668|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
71708669|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7912|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.7912
71708670|NCT02732145|142935170|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||1.0000
71708671|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.253|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.2530
71708672|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8338|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8338
71708673|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0019|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0019
71708674|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6541|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6541
71826540|NCT01335932|143157978|OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
71826541|NCT00952718|143158012|SUPERIORITY|||||||0.005||||||p-value for MIP was adjusted by linear regression model.|Regression, Linear|||||||0.005
71826542|NCT00952718|143158012|SUPERIORITY|||||||0.038||||||adjusted p for MEP by linear regression|Regression, Linear|||||||0.038
71708675|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8224|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8224
71708676|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0064|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0064
71708677|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9723|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9723
71826543|NCT00952718|143158013|SUPERIORITY|||||||0.063|||||||Regression, Linear|||||||0.063
71826544|NCT00952718|143158014|SUPERIORITY|||||||0.269|||||||Regression, Linear|||||||0.269
71826545|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|3.17||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||3.17|-4.52|
71708678|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8161|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.8161
71708679|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.1165|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.1165
71708680|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6339|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.6339
71708681|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9724|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.9724
71708682|NCT02732145|142935171|SUPERIORITY|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0016|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."||||0.0016
71708683|NCT02732145|142935172|EQUIVALENCE|Question: Is there a difference in the age of patients from different groups?||||||0|||||||ANOVA|||Parameter: The difference in the age of patients from different groups.||||0.0000
71708684|NCT02732145|142935173|EQUIVALENCE|Is there a difference in the weight of patients from different groups?||||||0|||||||ANOVA|||The difference in the weight of patients from different groups.||||0.0000
71708685|NCT02732145|142935174|EQUIVALENCE|Is there a difference in the height of patients from different groups.||||||0.0557|||||||ANOVA|||The difference in the height of patients from different groups.||||0.0557
71765244|NCT03456882|143032811|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.845|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.845
71708686|NCT02732145|142935175|EQUIVALENCE|Is there a difference in the body mass index of patients from different groups.||||||0|||||||ANOVA|||The difference in the body mass index of patients from different groups.||||0.0000
71886664|NCT02475655|143293585|SUPERIORITY||Mean Difference (Net)|-0.19||||0.92|TWO_SIDED|90.0|-3.56|3.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 12.||3.18|-3.56|0.92
71708687|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the incidence of patients older than 65 years in different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of patients older than 65 years between different groups.||||0.0000
71708688|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the incidence of menopausal patients among different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of menopausal patients among different groups.||||0.0000
71708689|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||||0.3708|||||||Chi-squared|||Parameter: The difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||0.3708
71708690|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the incidence of patients educated equally or less than 12 years among different groups?||||||0.018|||||||Chi-squared|||Parameter: The difference in the incidence of patients educated equally or less than 12 years among different groups.||||0.0180
71708691|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in marital status among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of marital status among patients from different groups.||||0.0000
71708692|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the nulliparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the nulliparity among patients from different groups.||||0.0000
71708693|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the multiparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the multiparity among patients from different groups.||||0.0000
71708694|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the number of abortions among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the number of abortions among patients from different groups.||||0.0000
71708695|NCT02732145|142935176|EQUIVALENCE|Question: Is there a difference in the using of contraception among patients from different groups?||||||0.1323|||||||Chi-squared|||Parameter: The difference in the using of contraception among patients from different groups.||||0.1323
71708696|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva among patients with vulvar discomfort?||||||0.3158|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) among patients with vulvar discomfort.||||0.3158
71765245|NCT03456882|143032812|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2161|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction.|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.2161
71708697|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of symptoms of the sharp pain of the vulva among patients with vulvar discomfort?||||||0.0007|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp pain in the vulva (stabbing, sticking, knife-like pain, paper-cuts pain) among patients with vulvar discomfort.||||0.0007
71708698|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvar dermatosis.||||0.0000
71886665|NCT02475655|143293586|SUPERIORITY||Mean Difference (Net)|-0.07||||0.82|TWO_SIDED|90.0|-0.61|0.47||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 5.||0.47|-0.61|0.82
71708699|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvodynia.||||0.0000
71708700|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar burning among patients with vulvar discomfort?||||||0.0147|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar burning among patients with vulvar discomfort.||||0.0147
71886666|NCT02475655|143293586|SUPERIORITY||Mean Difference (Net)|0.76||||0.033|TWO_SIDED|90.0|0.18|1.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 12.||1.34|0.18|0.033
71708701|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar stinging among patients with vulvar discomfort?||||||0.8456|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar stinging among patients with vulvar discomfort.||||0.8456
71708702|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of vulvar soreness among patients with vulvar discomfort?||||||0.0076|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar soreness among patients with vulvar discomfort.||||0.0076
71708703|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of irritation of the vulva among the patients with vulvar discomfort?||||||0.0423|||||||Chi-squared|||Parameter: The difference in the incidence of irritation of the vulva among patients with vulvar discomfort.||||0.0423
71708704|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of the knife-like pain in the vulva among the patients with vulvar discomfort?||||||0.0457|||||||Chi-squared|||Parameter: The difference in the incidence of the knife-like pain in the vulva among patients with vulvar discomfort.||||0.0457
71708705|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of the paper-cuts pain of the vulva among the patients with vulvar discomfort?||||||0.043|||||||Chi-squared|||Parameter: The difference in the incidence of the paper-cuts pain of the vulva among patients with vulvar discomfort.||||0.0430
71708706|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of the stabbing of the vulva among the patients with vulvar discomfort?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of the stabbing of the vulva among patients with vulvar discomfort.||||0.0134
71708707|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of sticking of the vulva among the patients with vulvar discomfort?||||||0.0581|||||||Chi-squared|||Parameter: The difference in the incidence of sticking of the vulva among patients with vulvar discomfort.||||0.0581
71708708|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of itching of the vulva among the patients with vulvar discomfort?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the incidence of itching of the vulva among patients with vulvar discomfort.||||0.0002
71708709|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of the feeling of inflammation of the vulva among the patients with vulvar discomfort?|t-test proportion|0.0||||0.0852|TWO_SIDED||||||Chi-squared|||Parameter: The difference in the incidence of the feeling of inflammation of the vulva among patients with vulvar discomfort.||||0.0852
71708710|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the incidence of aching of the vulva among the patients with vulvar discomfort?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of aching of the vulva among patients with vulvar discomfort.||||0.0001
71708711|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the association of different symptoms of the vulva among the patients with vulvar discomfort?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of association of different vulvar symptoms among patients with vulvar discomfort.||||0.0000
71708712|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvar dermatosis.||||0.0000
71708713|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus stinging in the patients with vulvar dermatosis?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus stinging in patients with vulvar dermatosis.||||0.0008
71708714|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvar dermatosis.||||0.0000
71826546|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.06|||||TWO_SIDED|98.25|-3.94|4.38||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococcal serotype 4.||4.38|-3.94|
71708715|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvar dermatosis.||||0.0000
71708716|NCT02732145|142935177|SUPERIORITY|||||||0||||||There was a statistically significant difference at p\<0.001. Patients with vulvar dermatosis had significantly more often itching than the feeling of inflammation of the vulva.|t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
71708717|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvar dermatosis.||||0.0000
71708718|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvar dermatosis.||||0.0000
71708719|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvar dermatosis.||||0.0000
71708720|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvar dermatosis.||||0.0000
71708721|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0000
71708722|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvar dermatosis.||||0.0000
71826547|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|3.19||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||3.19|-4.63|
71826548|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.69|||||TWO_SIDED|98.25|-9.4|10.99||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||10.99|-9.4|
71708723|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvar dermatosis?||||||0.8591|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvar dermatosis.||||0.8591
71708724|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvar dermatosis?||||||0.009|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvar dermatosis.||||0.0090
71765246|NCT03456882|143032813|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4962|TWO_SIDED|||||Significance level set to 0.05|repeated measures ANOVA|Repeated measures ANOVA with unstructured variance covariance matrix. Independent variables: time, treatment and treatment\*time interaction|RNS60 vs. Placebo|Contrast between treatment groups of the differences (week 48 - week 24) within treatment groups. Null hypothesis: the change from week 24 to week 48 is not different between treatment groups.||||0.4962
71708725|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvar dermatosis?||||||0.0212|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvar dermatosis.||||0.0212
71708726|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0.0057|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvar dermatosis.||||0.0057
71708727|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0977|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0977
71708728|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0143|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.0143
71765247|NCT03456882|143032814|SUPERIORITY|||||||0.8738||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 4 weeks. Null hypothesis: the number of adverse events occurred within 4 weeks is not different between groups||||0.8738
71765248|NCT03456882|143032814|SUPERIORITY|||||||0.7556||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 12 weeks. Null hypothesis: the number of adverse events occurred within 12 weeks is not different between groups||||0.7556
71765249|NCT03456882|143032814|SUPERIORITY|||||||0.6477||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 24 weeks. Null hypothesis: the number of adverse events occurred within 24 weeks is not different between groups||||0.6477
71765250|NCT03456882|143032814|SUPERIORITY|||||||0.6084||||||Significance level set to 0.05|Wilcoxon (Mann-Whitney)|||Mean AE treatment discontinuation 48 weeks. Null hypothesis: the number of adverse events occurred within 48 weeks is not different between groups||||0.6084
71765251|NCT00183729|143032828|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.42|TWO_SIDED||||||Mixed Models Analysis|||Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study||||0.42
71765252|NCT00183729|143032830|SUPERIORITY|(no comments)|Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|7.0||0.06|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.||||0.06
71765253|NCT03512457|143032831|SUPERIORITY|Chi-square||||||0.12||||||P-value of \<0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.|Chi-squared|Chi-Squared is equal to 1.58, with a P-Value of 0.12.||change from baseline to 3 months in performance of skin self-examination Parallel: response rate||||0.12
71765254|NCT03512457|143032832|SUPERIORITY|Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma|||||<|0.05|||||||Chi-squared|||results of skin clinical examination and biopsy of clinically suspicious moles||||<0.05
71765255|NCT00535288|143032887|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.2|||<|0.01|TWO_SIDED|95.0|-2.2|-0.2||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.2|-2.2|<0.01
71765256|NCT00535288|143032887|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.7|||<|0.01|TWO_SIDED|95.0|-2.7|-0.7||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.7|-2.7|<0.01
71765257|NCT00535288|143032887|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.4|||<|0.01|TWO_SIDED|95.0|-2.4|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.4|<0.01
71765258|NCT00535288|143032887|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-2.9|<0.01
71765259|NCT00535288|143032888|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.12|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.12|<0.01
71765260|NCT00535288|143032888|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.02|TWO_SIDED|95.0|-0.11|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.11|0.02
71765261|NCT00535288|143032888|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07|||<|0.01|TWO_SIDED|95.0|-0.13|-0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.02|-0.13|<0.01
71765262|NCT00535288|143032888|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.08|||<|0.01|TWO_SIDED|95.0|-0.14|-0.03||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.03|-0.14|<0.01
71765263|NCT00535288|143032889|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.0||||0.08|TWO_SIDED|95.0|-2.1|0.1||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||0.1|-2.1|0.08
71765264|NCT00535288|143032889|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.6|||<|0.01|TWO_SIDED|95.0|-2.7|-0.5||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.5|-2.7|<0.01
71765265|NCT00535288|143032889|SUPERIORITY_OR_OTHER||Difference between least squares means|-1.5|||<|0.01|TWO_SIDED|95.0|-2.7|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.4|-2.7|<0.01
71765266|NCT00535288|143032889|SUPERIORITY_OR_OTHER||Difference between least squares means|-2.0|||<|0.01|TWO_SIDED|95.0|-3.1|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency||||-0.9|-3.1|<0.01
71765267|NCT00535288|143032892|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.06||||0.07|TWO_SIDED|95.0|-0.12|0.0||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.00|-0.12|0.07
71765268|NCT00535288|143032892|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.05||||0.24|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.24
71765269|NCT00535288|143032892|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.04||||0.29|TWO_SIDED|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||0.02|-0.11|0.29
71765270|NCT00535288|143032892|SUPERIORITY_OR_OTHER||Difference between least squares means|-0.07||||0.02|TWO_SIDED|95.0|-0.14|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity||||-0.01|-0.14|0.02
71708729|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
71708730|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.682|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.6820
71708731|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.||||0.2059
71708732|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvodynia.||||0.0000
71708733|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvodynia?||||||0.0344|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvodynia.||||0.0344
71708734|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvodynia?||||||0.0023|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvodynia.||||0.0023
71765271|NCT00745849|143032901|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71765272|NCT01129583|143032902|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
71765273|NCT01129583|143032903|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
71826549|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.65|||||TWO_SIDED|98.25|-2.7|4.71||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||4.71|-2.7|
71708735|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus itching in the patients with vulvodynia?||||||0.5675|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus itching in patients with vulvodynia.||||0.5675
71708736|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvodynia?||||||0.0037|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvodynia.||||0.0037
71708737|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvodynia?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvodynia.||||0.0005
71708738|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvodynia.||||0.0000
71708739|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvodynia?||||||0.1201|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvodynia.||||0.1201
71708740|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvodynia?||||||0.0123|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvodynia.||||0.0123
71708741|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus the feeling of inflammation in the patients with vulvodynia?||||||0.0188|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvodynia.||||0.0188
71765274|NCT01129583|143032904|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
71765275|NCT02600871|143032905|SUPERIORITY|The significance of variation in proportions with treatment (Provodine®, Control) was assessed with Fisher's Exact tests and variation in the mean with treatment was assessed with T-tests.||||||0.71|||||||Fisher Exact|||||||0.71
71765276|NCT03745820|143032934|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.328|=|0.8472|TWO_SIDED|95.0|-2.88|2.37|||MMRM|||Mixed Model Repeated Measures(MMRM)model was used to analyze change from baseline of outcome measure(OM)using fixed effects of treatment group,region,study visit,study visit-by-treatment interaction,baseline value of OM,baseline-by-visit interaction.||2.37|-2.88|=0.8472
71708742|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvodynia?||||||0.003|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvodynia.||||0.0030
71708743|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvodynia?||||||0.2155|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvodynia.||||0.2155
71708744|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvodynia?||||||0.1508|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvodynia.||||0.1508
71708745|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvodynia?||||||0.6364|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvodynia.||||0.6364
71708746|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvodynia?||||||0.5277|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvodynia.||||0.5277
71708747|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.2041|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.2041
71708748|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.0412|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0412
71708749|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvodynia who had sharp vulvar pain?||||||0.7978|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvodynia who had sharp vulvar pain.||||0.7978
71708750|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.3094|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.||||0.3094
71708751|NCT02732145|142935177|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.073|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.||||0.0730
71708752|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis and vulvodynia?||||||0.4038|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis or vulvodynia.||||0.4038
71708753|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis and vulvodynia?||||||0.7299|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis or vulvodynia.||||0.7299
71708754|NCT02732145|142935177|EQUIVALENCE|Question: Is there a difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis and vulvodynia?||||||0.7241|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis or vulvodynia.||||0.7241
71708755|NCT02732145|142935178|EQUIVALENCE|Question: Is there a difference in the sexual activity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the sexual activity among patients from different groups.||||0.0000
71708756|NCT02732145|142935178|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups?||||||0.0006|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups.||||0.0006
71708757|NCT02732145|142935178|EQUIVALENCE|Question: Is there a difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups.||||0.0000
71708758|NCT02732145|142935179|EQUIVALENCE|Question: Is there a difference in the frequency of dyspareunia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia among patients from different groups.||||0.0000
71708759|NCT02732145|142935179|EQUIVALENCE|Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||||0.2999|||||||Chi-squared|||Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||0.2999
71708760|NCT02732145|142935180|EQUIVALENCE|Question: Is there a difference in the incidence of the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0000
71708761|NCT02732145|142935180|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis?||||||0.0347|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis.||||0.0347
71708762|NCT02732145|142935180|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.7068|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.7068
71655175|NCT04295135|142828328|SUPERIORITY||Median Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.003|>|0.05|TWO_SIDED|||||A multi-level linear probability model that included patient demographics, clinician random effects, and indicator variables for (a) site; (b) treatment and control clinicians; and (c) pre-/post-OneSheet access.|Regression, Linear|Model also included an interaction term for treatment and post-OneSheet access.|The coefficient estimates the causal effect of OneSheet on our outcomes. Unit of analysis was patient visit.|||||>0.05
71655176|NCT03835325|142828336|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The sample size calculation was based on the following hypothesis test:~H0: there is no improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~H1: there is an improvement in memory capacity between the initial (VS) and final (VF) assessments, assessed by the self-efficacy factor of the MIAr questionnaire.~or H0: AUTO-EF (VF) - AUTO-EF (VS) ≤ 0 H1: AUTO-EF (VF) - AUTO-EF (VS)\> 0"||||<0.001
71655177|NCT01901874|142828344|OTHER|"Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence.~Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4%~PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%"|Weighted binomial proportion|0.0448|STANDARD_ERROR_OF_MEAN|0.0241|<|1e-05|ONE_SIDED|95.1||0.0846||A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.|Binomial test (normal approximation)||Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.|"Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P \< 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1."||0.0846||<0.00001
71655178|NCT01901874|142828352|OTHER||Cumulative probability|0.018|||||TWO_SIDED|95.0|0.007|0.047|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.047|0.007|
71655179|NCT01901874|142828353|OTHER||Cumulative probability|0.022|||||TWO_SIDED|95.0|0.009|0.052|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)|||0.052|0.009|
71655180|NCT04632706|142828354|OTHER|||||||0.803||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.803
71655181|NCT04632706|142828356|OTHER|||||||0.689||||||If the p-value is more than 0.05 then dose proportionality can not be confirmed.|Mixed Models Analysis|||Assessment of dose proportionality on D2 and D28||||0.689
71655182|NCT03508687|142828359|OTHER|||||||0.517||||||paired t test; baseline vs. week 12 (n = 5)|t-test, 2 sided|||||||0.517
71655183|NCT03508687|142828359|OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Ranks Test (n = 5)||||||0.345
71655184|NCT01138111|142828385|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0001
71655185|NCT01138111|142828385|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0011
71655186|NCT01138111|142828385|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.||||0.0008
71655187|NCT00560937|142828406|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||T-test of change scores, pregnenolone vs. placebo post-treatment compared to baseline.||||.048
71655188|NCT00560937|142828407|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
71655189|NCT00560937|142828408|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
71655190|NCT00560937|142828409|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||T-test of change scores, pregnenolone compared to placebo post-treatment vs. pre-randomization.||||1.0
71708763|NCT02732145|142935180|EQUIVALENCE|Question: Is there a difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.0025|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis.||||0.0025
71655191|NCT00560937|142828410|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
71655192|NCT03629028|142828412|NON_INFERIORITY|Data compared to meta-analysis conducted in Sardo et al., 2017||||||0.05|||||||Chi-squared|Chi-squared or Fisher's test statistic was used to compare the categorical variables.||The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group.||||0.05
71655193|NCT02728752|142828421|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-11.5|-4.6|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16 for Total Activity Score||-4.6|-11.5|<0.0001
71655194|NCT02728752|142828427|SUPERIORITY||Median Difference (Net)|8.6||||0.0001|TWO_SIDED|95.0|4.4|12.8|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||12.8|4.4|0.0001
71655195|NCT02728752|142828428|SUPERIORITY||Median Difference (Net)|-0.4||||0.0002|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.2|-0.5|0.0002
71655196|NCT02728752|142828434|SUPERIORITY||Median Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5|||ANCOVA|With treatment, stratum and baseline as fixed effects, and site as random effect|Difference in LS Means of changes from baseline to week 16 (Octagam - Placebo)|LS Means difference between changes from baseline to week 16||-0.5|-1.9|0.0010
71708764|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis.||||0.0000
71655197|NCT02025751|142828438|SUPERIORITY|||||||0.597|||||||ANCOVA|||||||0.597
71655198|NCT00653991|142828440|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71655199|NCT01846273|142828442|NON_INFERIORITY|pre-defined non-inferiority margin of 5 letters|Least Squares Mean|3.2|||<|0.001|ONE_SIDED|95.0|0.38||||ANCOVA||||||0.38|<0.001
71655200|NCT01846273|142828443|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71655201|NCT03431974|142828466|SUPERIORITY|||||||0.43|||||||Fisher Exact|||The efficacy of LD-AMT established using a step-down analysis approach with one-sided Fisher's exact tests. First, the analysis for subjects attaining PASI 75 will be performed, then, if that analysis shows a significant treatment effect, analysis for subjects attaining a sPGA success will be performed.||||0.43
71655202|NCT03864042|142828489|OTHER||Geometric LS Mean Ratio|1.17|||||TWO_SIDED|90.0|0.978|1.4|||||Day 1 / Day -7|||1.40|0.978|
71655203|NCT03864042|142828489|OTHER||Geometric LS Mean Ratio|0.258|||||TWO_SIDED|90.0|0.215|0.308|||||Day 14 / Day -7|||0.308|0.215|
71655204|NCT03864042|142828490|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|0.998|1.25|||||Day 1 / Day -7|||1.25|0.998|
71655205|NCT03864042|142828490|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.12|1.4|||||Day 14 / Day -7|||1.40|1.12|
71655206|NCT03864042|142828491|OTHER||Geometric LS Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.62|||||Day 1 / Day -7|||1.62|1.12|
71655207|NCT03864042|142828491|OTHER||Geometric LS Mean Ratio|0.622|||||TWO_SIDED|90.0|0.517|0.748|||||Day 14 / Day -7|||0.748|0.517|
71655208|NCT03864042|142828492|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.975|1.23|||||Day 1 / Day -7|||1.23|0.975|
71655209|NCT03864042|142828492|OTHER||Geometric LS Mean Ratio|1.3|||||TWO_SIDED|90.0|1.16|1.46|||||Day 14 / Day -7|||1.46|1.16|
71655210|NCT03864042|142828493|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.922|1.2|||||Day 1 / Day -7|||1.20|0.922|
71655211|NCT03864042|142828493|OTHER||Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|0.992|1.29|||||Day 14 / Day -7|||1.29|0.992|
71655212|NCT03864042|142828494|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.19|||||Day 1 / Day -7|||1.19|0.990|
71655213|NCT03864042|142828494|OTHER||Geometric LS Mean Ratio|1.1|||||TWO_SIDED|90.0|1.0|1.22|||||Day 14 / Day -7|||1.22|1.00|
71655214|NCT03864042|142828495|OTHER||Geometric LS Mean Ratio|0.894|||||TWO_SIDED|90.0|0.741|1.08|||||Day 1 / Day -7|||1.08|0.741|
71655215|NCT03864042|142828495|OTHER||Geometric LS Mean Ratio|0.692|||||TWO_SIDED|90.0|0.573|0.835|||||Day 14 / Day -7|||0.835|0.573|
71655216|NCT03864042|142828496|OTHER||Geometric LS Mean Ratio|1.32|||||TWO_SIDED|90.0|0.861|2.04|||||Day 1 / Day -7|||2.04|0.861|
71655217|NCT03864042|142828496|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.659|1.56|||||Day 14 / Day -7|||1.56|0.659|
71655218|NCT03864042|142828497|OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.762|1.33|||||Day 1 / Day -7|||1.33|0.762|
71655219|NCT03864042|142828497|OTHER||Geometric LS Mean Ratio|0.718|||||TWO_SIDED|90.0|0.543|0.948|||||Day 14 / Day -7|||0.948|0.543|
71655220|NCT03864042|142828498|OTHER||Geometric LS Mean Ratio|4.34|||||TWO_SIDED|90.0|2.94|6.4|||||Day 1 / Day -7|||6.40|2.94|
71655221|NCT03864042|142828498|OTHER||Geometric LS Mean Ratio|2.68|||||TWO_SIDED|90.0|1.82|3.96|||||Day 14 / Day -7|||3.96|1.82|
71655222|NCT03864042|142828499|OTHER||Geometric LS Mean Ratio|0.754|||||TWO_SIDED|90.0|0.595|0.954|||||Day 1 / Day -7|||0.954|0.595|
71655223|NCT03864042|142828499|OTHER||Geometric LS Mean Ratio|0.755|||||TWO_SIDED|90.0|0.596|0.957|||||Day 14 / Day -7|||0.957|0.596|
71655224|NCT03864042|142828500|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.864|1.27|||||Day 1 / Day -7|||1.27|0.864|
71655225|NCT03864042|142828500|OTHER||Geometric LS Mean Ratio|1.42|||||TWO_SIDED|90.0|1.17|1.72|||||Day 14 / Day -7|||1.72|1.17|
71655226|NCT03864042|142828501|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.92|1.25|||||Day 1 / Day -7|||1.25|0.920|
71655227|NCT03864042|142828501|OTHER||Geometric LS Mean Ratio|0.175|||||TWO_SIDED|90.0|0.151|0.204|||||Day 14 / Day -7|||0.204|0.151|
71655228|NCT03864042|142828502|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.18|1.38|||||Day 1 / Day -7|||1.38|1.18|
71655229|NCT03864042|142828502|OTHER||Geometric LS Mean Ratio|1.05|||||TWO_SIDED|90.0|0.974|1.14|||||Day 14 / Day -7|||1.14|0.974|
71655230|NCT03864042|142828503|OTHER||Geometric LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.09|1.43|||||Day 1 / Day -7|||1.43|1.09|
71655231|NCT03864042|142828503|OTHER||Geometric LS Mean Ratio|0.513|||||TWO_SIDED|90.0|0.449|0.587|||||Day 14 / Day -7|||0.587|0.449|
71655232|NCT03864042|142828504|OTHER||Geometric LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.17|1.39|||||Day 1 / Day -7|||1.39|1.17|
71655233|NCT03864042|142828504|OTHER||Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.979|1.16|||||Day 14 / Day -7|||1.16|0.979|
71655234|NCT03864042|142828505|OTHER||Geometric LS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.947|1.26|||||Day 1 / Day -7|||1.26|0.947|
71655235|NCT03864042|142828505|OTHER||Geometric LS Mean Ratio|1.27|||||TWO_SIDED|90.0|1.1|1.46|||||Day 14 / Day -7|||1.46|1.10|
71655236|NCT03864042|142828506|OTHER||Geometric LS Mean Ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23|||||Day 1 / Day -7|||1.23|1.02|
71655237|NCT03864042|142828506|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|1.14|1.38|||||Day 14 / Day -7|||1.38|1.14|
71655238|NCT03864042|142828507|OTHER||Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.721|1.12|||||Day 1 / Day -7|||1.12|0.721|
71655239|NCT03864042|142828507|OTHER||Geometric LS Mean Ratio|0.679|||||TWO_SIDED|90.0|0.544|0.848|||||Day 14 / Day -7|||0.848|0.544|
71655240|NCT03864042|142828508|OTHER||Geometric LS Mean Ratio|1.26|||||TWO_SIDED|90.0|0.8|1.98|||||Day 1 / Day -7|||1.98|0.800|
71655241|NCT03864042|142828508|OTHER||Geometric LS Mean Ratio|0.827|||||TWO_SIDED|90.0|0.526|1.3|||||Day 14 / Day -7|||1.30|0.526|
71655242|NCT03864042|142828509|OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.688|1.39|||||Day 1 / Day -7|||1.39|0.688|
71655243|NCT03864042|142828509|OTHER||Geometric LS Mean Ratio|0.633|||||TWO_SIDED|90.0|0.445|0.9|||||Day 14 / Day -7|||0.900|0.445|
71655244|NCT03864042|142828510|OTHER||Geometric LS Mean Ratio|2.79|||||TWO_SIDED|90.0|2.08|3.74|||||Day 1 / Day -7|||3.74|2.08|
71655245|NCT03864042|142828510|OTHER||Geometric LS Mean Ratio|1.57|||||TWO_SIDED|90.0|1.17|2.11|||||Day 14 / Day -7|||2.11|1.17|
71655246|NCT03864042|142828511|OTHER||Geometric LS Mean Ratio|0.769|||||TWO_SIDED|90.0|0.637|0.928|||||Day 1 / Day -7|||0.928|0.637|
71655247|NCT03864042|142828511|OTHER||Geometric LS Mean Ratio|0.736|||||TWO_SIDED|90.0|0.61|0.889|||||Day 14 / Day -7|||0.889|0.610|
71708765|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons?||||||0.6552|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons.||||0.6552
71708766|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis.||||0.0002
71708767|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle?||||||0.2877|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle.||||0.2877
71708768|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia.||||0.0001
71708769|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes?||||||0.4754|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes.||||0.4754
71708770|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age?||||||0.1082|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age.||||0.1082
71708771|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age?||||||0.0179|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age.||||0.0179
71708772|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age?||||||0.5722|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age.||||0.5722
71708773|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age?||||||0.6148|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age.||||0.6148
71708774|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age?||||||0.5307|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age.||||0.5307
71708775|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar discomfort during urination?||||||0.1546|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during urination.||||0.1546
71708776|NCT02732145|142935181|SUPERIORITY|Question: Is there a difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active?||||||0.1019|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active.||||0.1019
71708777|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of problems associated with urination and defecation between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of problems associated with urination and defecation between patients from different groups.||||0.0000
71708778|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of dysuria between patients from different groups.||||0.0000
71708779|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent dysuria between patients from different groups.||||0.0000
71708780|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent dysuria between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent dysuria between patients from different groups.||||0.0003
71708781|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of urinary incontinence between patients from different groups?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of urinary incontinence between patients from different groups.||||0.0010
71708782|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urinary incontinence between patients from different groups?||||||0.1859|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urinary incontinence between patients from different groups.||||0.1859
71708783|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urinary incontinence between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urinary incontinence between patients from different groups.||||0.0003
71708784|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of difficulties at starting urination between patients from different groups?||||||0.0015|||||||Chi-squared|||Parameter: The difference in the incidence of difficulties at starting urination between patients from different groups.||||0.0015
71708785|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent difficulties at starting urination between patients from different groups?||||||0.0013|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent difficulties at starting urination between patients from different groups.||||0.0013
71708786|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent difficulties at starting urination between patients from different groups?||||||0.5673|||||||Chi-squared|||Parameter: The difference in the incidence of frequent difficulties at starting urination between patients from different groups.||||0.5673
71708787|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of urgency between patients from different groups?||||||0.0065|||||||Chi-squared|||Parameter: The difference in the incidence of urgency between patients from different groups.||||0.0065
71708788|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent urgency between patients from different groups?||||||0.083|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urgency between patients from different groups.||||0.0830
71708789|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent urgency between patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urgency between patients from different groups.||||0.0001
71708790|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of nocturia between patients from different groups.||||0.0000
71765277|NCT03745820|143032934|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.323|=|0.8053|TWO_SIDED|95.0|-2.94|2.29|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.29|-2.94|=0.8053
71765278|NCT03745820|143032938|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|1.835|=|0.0637|TWO_SIDED|95.0|-0.2|7.06|||ANCOVA|||An analysis of covariance (ANCOVA) model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.20|=0.0637
71765279|NCT03745820|143032938|SUPERIORITY||LS Mean Difference|3.42|STANDARD_ERROR_OF_MEAN|1.844|=|0.0659|TWO_SIDED|95.0|-0.23|7.06|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||7.06|-0.23|=0.0659
71765280|NCT03745820|143032939|SUPERIORITY||LS Mean Difference|0.208|STANDARD_ERROR_OF_MEAN|0.09|=|0.6653|TWO_SIDED|95.0|-0.32|0.5|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.50|-0.32|=0.6653
71765281|NCT03745820|143032939|SUPERIORITY||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.1|=|0.614|TWO_SIDED|95.0|-0.3|0.51|||ANCOVA|||An ANCOVA model was applied adjusting for treatment group and baseline value of the OM.||0.51|-0.30|=0.6140
71765282|NCT03745820|143032940|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.033|=|0.2886|TWO_SIDED|95.0|-3.14|0.94|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.94|-3.14|=0.2886
71765283|NCT03745820|143032940|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.032|=|0.6349|TWO_SIDED|95.0|-1.55|2.53|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||2.53|-1.55|=0.6349
71765284|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.345|=|0.7372|TWO_SIDED|95.0|-2.21|3.11||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||3.11|-2.21|=0.7372
71765285|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|1.346|=|0.6894|TWO_SIDED|95.0|-3.2|2.12||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Verbal Learning: Change From Baseline at Week 12||2.12|-3.20|=0.6894
71886667|NCT02475655|143293587|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|90.0|-0.53|0.55||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 5.||0.55|-0.53|0.98
71708791|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent nocturia between patients from different groups?||||||0.2315|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent nocturia between patients from different groups.||||0.2315
71708792|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of frequent nocturia between patients from different groups.||||0.0000
71708793|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent cystitis between patients from different groups?||||||0.0539|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent cystitis between patients from different groups.||||0.0539
71708794|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of constipation between patients from different groups?||||||0.0379|||||||Chi-squared|||Parameter: The difference in the incidence of constipation between patients from different groups.||||0.0379
71708795|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent constipation between patients from different groups?||||||0.1485|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent constipation between patients from different groups.||||0.1485
71708796|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent constipation between patients from different groups?||||||0.4155|||||||Chi-squared|||Parameter: The difference in the incidence of frequent constipation between patients from different groups.||||0.4155
71826550|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.05|3.82||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||3.82|-5.05|
71765286|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|1.162|=|0.0674|TWO_SIDED|95.0|-4.44|0.16||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||0.16|-4.44|=0.0674
71765287|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.161|=|0.7132|TWO_SIDED|95.0|-2.72|1.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Speed of Processing: Change From Baseline at Week 12||1.87|-2.72|=0.7132
71765288|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|1.203|=|0.9428|TWO_SIDED|95.0|-2.46|2.29||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||2.29|-2.46|=0.9428
71765289|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|1.202|=|0.4425|TWO_SIDED|95.0|-1.45|3.3||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Attention/Vigilance: Change From Baseline at Week 12||3.30|-1.45|=0.4425
71765290|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.597|=|0.3455|TWO_SIDED|95.0|-4.66|1.64||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||1.64|-4.66|=0.3455
71765291|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|1.595|=|0.9686|TWO_SIDED|95.0|-3.09|3.21||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Visual Learning: Change From Baseline at Week 12||3.21|-3.09|=0.9686
71765292|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|1.351|=|0.3832|TWO_SIDED|95.0|-1.49|3.85||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.85|-1.49|=0.3832
71765293|NCT03745820|143032941|SUPERIORITY||LS Mean DIfference|1.07|STANDARD_ERROR_OF_MEAN|1.357|=|0.4297|TWO_SIDED|95.0|-1.61|3.75||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Social Cognition: Change From Baseline at Week 12||3.75|-1.61|=0.4297
71765294|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.438|=|0.6245|TWO_SIDED|95.0|-3.55|2.14||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||2.14|-3.55|=0.6245
71765295|NCT03745820|143032941|SUPERIORITY||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|1.436|=|0.2698|TWO_SIDED|95.0|-1.25|4.43||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Reasoning and Problem Solving: Change From Baseline at Week 12||4.43|-1.25|=0.2698
71765296|NCT03745820|143032942|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.61|=|0.4654|TWO_SIDED|95.0|-1.65|0.76||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.76|-1.65|=0.4654
71826551|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.65|||||TWO_SIDED|98.25|-4.68|3.15||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||3.15|-4.68|
71765297|NCT03745820|143032942|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.608|=|0.5886|TWO_SIDED|95.0|-1.53|0.87||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Positive Symptoms Subscale: Change From Baseline at Week 12||0.87|-1.53|=0.5886
71765298|NCT03745820|143032942|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.655|=|0.9079|TWO_SIDED|95.0|-1.37|1.22||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||1.22|-1.37|=0.9079
71655248|NCT03864042|142828512|OTHER||Geometric LS Mean Ratio|0.993|||||TWO_SIDED|90.0|0.803|1.23|||||Day 1 / Day -7|||1.23|0.803|
71655249|NCT03864042|142828512|OTHER||Geometric LS Mean Ratio|1.48|||||TWO_SIDED|90.0|1.2|1.83|||||Day 14 / Day -7|||1.83|1.20|
71708797|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of diarrhea between patients from different groups?||||||0.0092|||||||Chi-squared|||Parameter: The difference in the incidence of diarrhea between patients from different groups.||||0.0092
71708798|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of intermittent diarrhea between patients from different groups?||||||0.0192|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent diarrhea between patients from different groups.||||0.0192
71708799|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of frequent diarrhea between patients from different groups?||||||0.5253|||||||Chi-squared|||Parameter: The difference in the incidence of frequent diarrhea between patients from different groups.||||0.5253
71655250|NCT03864042|142828513|OTHER||Geometric LS Mean Ratio|1.45|||||TWO_SIDED|90.0|0.902|2.32|||||Day 1 / Day -7|||2.32|0.902|
71655251|NCT03864042|142828513|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.72|1.93|||||Day 14 / Day -7|||1.93|0.720|
71655252|NCT03864042|142828514|OTHER||Geometric LS Mean Ratio|1.47|||||TWO_SIDED|90.0|0.915|2.36|||||Day 1 / Day -7|||2.36|0.915|
71708800|NCT02732145|142935182|EQUIVALENCE|Question: Is there a difference in the incidence of the irritable colon between patients from different groups?||||||0.006|||||||Chi-squared|||Parameter: The difference in the incidence of the irritable colon between patients from different groups.||||0.0060
71708801|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of any associated symptom or disease among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of any associated symptom or disease among patients from different groups.||||0.0000
71708802|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of a frequent headache among patients from different groups?||||||0.3957|||||||Chi-squared|||Parameter: The difference in the incidence of a frequent headache among patients from different groups.||||0.3957
71708803|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of chronic fatigue among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of chronic fatigue among patients from different groups.||||0.0000
71708804|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of lumbar pain among patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of lumbar pain among patients from different groups.||||0.0001
71708805|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of fibromyalgia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of fibromyalgia among patients from different groups.||||0.0000
71708806|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of energy loss among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of energy loss among patients from different groups.||||0.0000
71708807|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of sleep disorders among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of sleep disorders among patients from different groups.||||0.0000
71708808|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of pelvic pain among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of pelvic pain among patients from different groups.||||0.0000
71708809|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of unintended weight loss among patients from different groups?||||||0.1764|||||||Chi-squared|||Parameter: The difference in the incidence of unintended weight loss among patients from different groups.||||0.1764
71708810|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of endometriosis among patients from different groups?||||||0.3127|||||||Chi-squared|||Parameter: The difference in the incidence of endometriosis among patients from different groups.||||0.3127
71708811|NCT02732145|142935183|EQUIVALENCE|"Question: Is there a difference in the incidence of D-D-D Triad among patients from different groups?"||||||0.0028|||||||Chi-squared|||"Parameter: The difference in the difference in the incidence of D-D-D Triad (Dysmenorrhoea-Dyspareunia-Dysuria) among patients from different groups."||||0.0028
71708812|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of hypertension among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of hypertension among patients from different groups.||||0.0000
71708813|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of genital herpes among patients from different groups?||||||0.9323|||||||Chi-squared|||Parameter: The difference in the incidence of genital herpes among patients from different groups.||||0.9323
71655253|NCT03864042|142828514|OTHER||Geometric LS Mean Ratio|0.851|||||TWO_SIDED|90.0|0.519|1.39|||||Day 14 / Day -7|||1.39|0.519|
71708814|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of thyroid disease among patients from different groups?||||||0.0011|||||||Chi-squared|||Parameter: The difference in the incidence of thyroid disease among patients from different groups.||||0.0011
71708815|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of drug allergy among patients from different groups?||||||0.2756|||||||Chi-squared|||Parameter: The difference in the incidence of drug allergy among patients from different groups.||||0.2756
71708816|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of recurrent attacks of sinusitis among patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent attacks of sinusitis among patients from different groups.||||0.0105
71655254|NCT03864042|142828515|OTHER||Geometric LS Mean Ratio|1.2|||||TWO_SIDED|90.0|0.775|1.87|||||Day 1 / Day -7|||1.87|0.775|
71655255|NCT03864042|142828515|OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.593|1.49|||||Day 14 / Day -7|||1.49|0.593|
71655256|NCT03864042|142828516|OTHER||Geometric LS Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||Day 1 / Day -7|||1.67|0.830|
71655257|NCT03864042|142828516|OTHER||Geometric LS Mean Ratio|0.979|||||TWO_SIDED|90.0|0.68|1.41|||||Day 14 / Day -7|||1.41|0.680|
71655258|NCT03864042|142828517|OTHER||Geometric LS Mean Ratio|0.798|||||TWO_SIDED|90.0|0.585|1.09|||||Day 21 / Day 14|||1.09|0.585|
71655259|NCT03864042|142828518|OTHER||Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.935|1.11|||||Day 21 / Day 14|||1.11|0.935|
71708817|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of HPV infection among patients from different groups, who were tested for HPV?||||||0.2128|||||||Chi-squared|||Parameter: The difference in the incidence of HPV infection among patients from different groups, who were tested for HPV.||||0.2128
71708818|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of abnormal PAP smear among patients from different groups?||||||0.0018|||||||Chi-squared|||Parameter: The difference in the incidence of abnormal PAP smear among patients from different groups.||||0.0018
71708819|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of genital warts among patients from different groups?||||||0.2524|||||||Chi-squared|||Parameter: The difference in the incidence of genital warts among patients from different groups.||||0.2524
71708820|NCT02732145|142935183|EQUIVALENCE|Question: Is there a difference in the incidence of conization or LETZ among patients from different groups?||||||0.2452|||||||Chi-squared|||Parameter: The difference in the incidence of conization or LETZ among patients from different groups.||||0.2452
71708821|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia?||||||0.1583|||||||Chi-squared|||Parameter: The difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia.||||0.1583
71708822|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.038|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.0380
71708823|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antifungals among patients with vulvar dermatosis and vulvodynia.||||0.6468
71655260|NCT03864042|142828519|OTHER||Geometric LS Mean Ratio|0.762|||||TWO_SIDED|90.0|0.613|0.945|||||Day 21 / Day 14|||0.945|0.613|
71655261|NCT03864042|142828520|OTHER||Geometric LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.929|1.22|||||Day 21 / Day 14|||1.22|0.929|
71655262|NCT00375492|142828772|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Model Repeated Measures|||||||0.0030
71655263|NCT00375492|142828773|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures|||||||<0.0001
71655264|NCT00375492|142828775|SUPERIORITY_OR_OTHER|||||||0.1985||95.0|||||Mixed Model Repeated Measures|||||||0.1985
71655265|NCT00375492|142828776|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||ANCOVA|||||||0.1827
71655266|NCT00375492|142828777|SUPERIORITY_OR_OTHER|||||||0.1584||95.0|||||ANCOVA|||||||0.1584
71655267|NCT00375492|142828778|SUPERIORITY_OR_OTHER|||||||0.8279||95.0|||||ANCOVA|||||||0.8279
71655268|NCT00375492|142828779|SUPERIORITY_OR_OTHER|||||||0.8334||95.0|||||ANCOVA|||||||0.8334
71655269|NCT00375492|142828780|SUPERIORITY_OR_OTHER|||||||0.2881||95.0|||||ANCOVA|||||||0.2881
71655270|NCT00375492|142828781|SUPERIORITY_OR_OTHER|||||||0.0654||95.0|||||ANCOVA|||||||0.0654
71655271|NCT00375492|142828782|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Cochran-Mantel-Haenszel|||||||0.728
71655272|NCT00375492|142828783|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||ANOVA|||||||0.127
71655273|NCT01232491|142828788|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.49||||0.132||95.0|-0.15|1.13||If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference \[dietary intervention versus no dietary intervention\]) was less than 0 then superiority for dietary intervention was considered confirmed.|Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.||1.13|-0.15|0.132
71655274|NCT01232491|142828789|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.17||||0.137||95.0|-0.05|0.39|||Regression, Linear|||Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.||0.39|-0.05|0.137
71655275|NCT01232491|142828790|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.13||||0.053||95.0|0.0|0.26|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.||0.26|-0.00|0.053
71655276|NCT01232491|142828791|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS Mean|0.07||||0.674||95.0|-0.25|0.39|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.||0.39|-0.25|0.674
71655277|NCT00856973|142828827|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|7.33|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-5.17|19.83|||ANCOVA|Bonferroni adjustment was use for multiple comparisons|Difference calculated as Eszopiclone minus placebo|This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou||19.83|-5.17|>0.05
71655278|NCT00856973|142828827|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|2.21|STANDARD_ERROR_OF_MEAN|3.91|>|0.05|TWO_SIDED|97.5|-10.23|14.65|||ANCOVA|||This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.||14.65|-10.23|>0.05
71655279|NCT03439852|142828855|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.05|TWO_SIDED|95.0|0.26|1.39|||Mixed Models Analysis|||Multilevel modeling for repeated measures was conducted to compare 2 conditions over time. The model included group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||1.39|0.26|<0.05
71655280|NCT03439852|142828856|SUPERIORITY||Median Difference (Net)|1.14||||0.05|TWO_SIDED|95.0|-0.37|2.64||Calculated|Mixed Models Analysis|||Multilevel modeling conducted for repeated measures comparing minutes per week of light-to-moderate physical activity for participants in two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||2.64|-0.37|0.05
71655281|NCT03439852|142828857|SUPERIORITY||Mean Difference (Net)|-0.72||||0.05|TWO_SIDED|95.0|-2.31|0.88|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation. The response was transformed using squared root to satisfy the model assumption.||0.88|-2.31|0.05
71655282|NCT03439852|142828858|SUPERIORITY||Mean Difference (Net)|0.96|||<|0.05|TWO_SIDED|95.0|-2.67|4.6|||Mixed Models Analysis|||Multilevel modeling for the repeated measures was conducted comparing the two conditions over time. In the multilevel models, participants were nested within Catholic Clubs, adjusting for within-club and within-subject correlations. The model includes group, time, and the interaction between group and time, adjusting for within-subject correlation.||4.60|-2.67|<0.05
71655283|NCT03439852|142828859|SUPERIORITY||Mean Difference (Net)|-0.76|||<|0.05|TWO_SIDED|95.0|-1.11|-0.4|||Mixed Models Analysis|||||-0.40|-1.11|<0.05
71655284|NCT03439852|142828860|SUPERIORITY||Mean Difference (Net)|-0.62|||<|0.05|TWO_SIDED|95.0|-1.15|0.1|||Mixed Models Analysis|||||0.10|-1.15|<0.05
71655285|NCT03439852|142828861|SUPERIORITY||Median Difference (Net)|-0.49|||<|0.05|TWO_SIDED|95.0|-2.1|1.11|||Mixed Models Analysis|Repeated measures generalized linear model test effects of time/group, \& interaction rate met MVPA, adjusting for within subject correlation.||||1.11|-2.10|<0.05
71655286|NCT02040779|142828943|SUPERIORITY||LSM difference|0.116||||0.001|TWO_SIDED|95.0|0.048|0.185||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 160 mcg BAI - Placebo BAI|A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.||0.185|0.048|0.0010
71655287|NCT02040779|142828943|SUPERIORITY||LSM difference|0.124||||0.0005|TWO_SIDED|95.0|0.054|0.193||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 80 mcg BAI - Placebo BAI|||0.193|0.054|0.0005
71655288|NCT02040779|142828944|SUPERIORITY||LSM difference|7.911||||0.0443|TWO_SIDED|95.0|0.202|15.621||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||15.621|0.202|0.0443
71655289|NCT02040779|142828944|SUPERIORITY||LSM difference|13.645||||0.0007|TWO_SIDED|95.0|5.843|21.446||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||21.446|5.843|0.0007
71655290|NCT02040779|142828945|SUPERIORITY||LSM difference|5.405||||0.2014|TWO_SIDED|95.0|-2.905|13.715||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||13.715|-2.905|0.2014
71708824|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.467|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.4670
71708825|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.2131|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.||||0.2131
71708826|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of previous local treatment with corticosteroids between the patients with vulvar dermatosis and vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with corticoids among patients with vulvar dermatosis and vulvodynia.||||0.0000
71708827|NCT02732145|142935184|SUPERIORITY|Question: Is there a difference in the frequency of previous systemic treatment with antidepressant between the patients with vulvar dermatosis and vulvodynia?||||||0.0962|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antidepressant among patients with vulvar dermatosis and vulvodynia.||||0.0962
71708828|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups.||||0.0000
71708829|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups.||||0.0000
71708830|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups.||||0.0000
71708831|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups.||||0.0000
71708832|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups.||||0.0000
71708833|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups.||||0.0000
71708834|NCT02732145|142935185|EQUIVALENCE|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups.||||0.0000
71708835|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva?||||||0.0009|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva.||||0.0009
71708836|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva?||||||0.0289|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva.||||0.0289
71708837|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis versus normal vulva?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis and normal vulva.||||0.0134
71708838|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis versus normal vulva?||||||0.0037|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis and normal vulva.||||0.0037
71708839|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva?||||||0.008|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva.||||0.0080
71708840|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis versus normal vulva?||||||0.0579|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis and normal vulva.||||0.0579
71708841|NCT02732145|142935185|SUPERIORITY|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis versus normal vulva?||||||0.072|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis and normal vulva.||||0.0720
71708842|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708843|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708844|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71765299|NCT03745820|143032942|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65|=|0.4441|TWO_SIDED|95.0|-1.78|0.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Negative Symptoms Subscale: Change From Baseline at Week 12||0.79|-1.78|=0.4441
71708845|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708846|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708847|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708848|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708849|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of fissures the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708850|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708851|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708852|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Inner Vulvar Ring between patients within different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708853|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Middle Vulvar Ring between patients from different groups?||||||0.0632|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0632
71708854|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of ischemia of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71826552|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||TWO_SIDED|98.25|-5.04|3.85||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.85|-5.04|
71708855|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Middle Vulvar Ring between patients within different groups?||||||0.0043|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0043
71708856|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of punctuation of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Typ), evaluated with Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71826553|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.6|3.14||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||3.14|-4.6|
71708857|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of papillae of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of papillae of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708858|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.0697|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.0697
71708859|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0319|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0319
71708860|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.7273|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.7273
71708861|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708862|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708863|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia?||||||0.2203|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.2203
71708864|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin.||||0.0000
71708865|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.0000
71708866|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0.1456|||||||t-test proportion|||Parameter: The incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.||||0.1456
71886668|NCT02475655|143293587|SUPERIORITY||Mean Difference (Net)|0.55||||0.37|TWO_SIDED|90.0|-0.46|1.57||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 12.||1.57|-0.46|0.37
71708867|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.1133|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.||||0.1133
71708868|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0000
71708869|NCT02732145|142935186|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0058|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.||||0.0058
71708870|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Mons pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708871|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708872|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708873|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708874|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708875|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708876|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708877|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71826554|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.08||||||98.25|-7.66|8.1||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||8.1|-7.66|
71708878|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of excoriations of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708879|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Mons Pubis among patients from different groups?||||||0.0016|||||||Chi-squared|||"Parameter: The incidence of rhagades of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0016
71708880|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708881|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of rhagades of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71886669|NCT02475655|143293588|SUPERIORITY||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|90.0|-4.72|-1.87||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 5.||-1.87|-4.72|<0.001
71708882|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0014|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0014
71708883|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
71708884|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0414|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0414
71708885|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia?||||||0.0898|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0898
71708886|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0008|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0008
71708887|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0587|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0587
71708888|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin.||||1.0000
71708889|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
71708890|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin.||||0.1352
71708891|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis.||||0.0002
71708892|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0000
71708893|NCT02732145|142935187|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0854|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis.||||0.0854
71708894|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708895|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708896|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71826555|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-4.52|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.||2.91|-4.52|
71826556|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||TWO_SIDED|98.25|-4.57|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 4.||2.91|-4.57|
71826557|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||TWO_SIDED|98.25|-4.63|2.92||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.||2.92|-4.63|
71826558|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-2.38|||||TWO_SIDED|98.25|-12.02|7.22||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.||7.22|-12.02|
71708897|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71826559|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-3.34|3.48||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.||3.48|-3.34|
71708898|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Anterior Commissure among patients from different groups?||||||0.0199|||||||Chi-squared|||"Parameter: The incidence of erythema of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0199
71708899|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708900|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of erythema of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708901|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of erythema of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708902|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of fissures of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708903|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of fissures of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71826560|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-1.27|||||TWO_SIDED|98.25|-5.66|2.32||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.||2.32|-5.66|
71655291|NCT02040779|142828945|SUPERIORITY||LSM difference|10.902||||0.0112|TWO_SIDED|95.0|2.5|19.303||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||19.303|2.500|0.0112
71655292|NCT02040779|142828946|SUPERIORITY||LSM difference|-0.388||||0.0175|TWO_SIDED|95.0|-0.708|-0.068||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.068|-0.708|0.0175
71655293|NCT02040779|142828946|SUPERIORITY||LSM difference|-0.358||||0.0285|TWO_SIDED|95.0|-0.678|-0.038||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.038|-0.678|0.0285
71655294|NCT02040779|142828947|SUPERIORITY||LSM difference|-0.137||||0.0335|TWO_SIDED|95.0|-0.263|-0.011||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||-0.011|-0.263|0.0335
71655295|NCT02040779|142828947|SUPERIORITY||LSM difference|-0.127||||0.0509|TWO_SIDED|95.0|-0.255|0.001||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||0.001|-0.255|0.0509
71655296|NCT02040779|142828949|SUPERIORITY|||||||0.2384|||||||Log Rank|||||||0.2384
71655297|NCT02040779|142828949|SUPERIORITY|||||||0.0208|||||||Log Rank|||||||0.0208
71655298|NCT03716076|142828972|OTHER|mixed-effects linear regression|||||||||||||||||To compare time values to baseline, post-hoc Tukey's test was applied|||
71655299|NCT03687658|142828992|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.066|||||||Generalized linear mixed model|||||||0.066
71826561|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||TWO_SIDED|98.25|-4.08|4.12||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.||4.12|-4.08|
71655300|NCT03687658|142828993|OTHER|Generalized linear mixed model (GLMM) with a binomial distribution using a logit link function||||||0.273|||||||Generalized linear mixed model|||||||0.273
71655301|NCT03687658|142828994|OTHER|Generalized linear mixed model (GLMM) with a Poisson distribution using a log link function||||||0.403|||||||Generalized linear mixed model|||||||0.403
71655302|NCT00986180|142829062|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|16.02||0.9703|TWO_SIDED|95.0|-32.1|30.9|||ANCOVA|||||30.9|-32.1|0.9703
71655303|NCT00986180|142829063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|6.08||0.7691|TWO_SIDED|95.0|-10.1|13.7|||ANCOVA|||||13.7|-10.1|0.7691
71655304|NCT00986180|142829064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|9.24||0.9282|TWO_SIDED|95.0|-17.3|19.0|||ANCOVA|||||19.0|-17.3|0.9282
71655305|NCT00986180|142829065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|29.75||0.9562|TWO_SIDED|95.0|-60.1|56.8|||ANCOVA|||||56.8|-60.1|0.9562
71655306|NCT00986180|142829066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|6.08||0.7973|TWO_SIDED|95.0|-13.5|10.4|||ANCOVA|||||10.4|-13.5|0.7973
71655307|NCT00986180|142829067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|9.3||0.7882|TWO_SIDED|95.0|-20.8|15.8|||ANCOVA|||||15.8|-20.8|0.7882
71826562|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||TWO_SIDED|98.25|-5.08|3.54||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.||3.54|-5.08|
71826563|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.67|||||TWO_SIDED|98.25|-3.4|5.2||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.||5.2|-3.4|
71826564|NCT01235949|143158015|NON_INFERIORITY|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (\<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|2.73|||||TWO_SIDED|98.25|-5.3|11.04||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.||11.04|-5.3|
71826565|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.71|1.29||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.29|0.71|
71826566|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.77|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.35|0.77|
71708904|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71826567|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.06|||||TWO_SIDED|99.8|0.8|1.41||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.41|0.8|
71826568|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.12|||||TWO_SIDED|99.8|0.72|1.74||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.74|0.72|
71826569|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.04|||||TWO_SIDED|99.8|0.79|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.35|0.79|
71655308|NCT00986180|142829068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|15.82||0.7491|TWO_SIDED|95.0|-36.1|26.0|||ANCOVA|||||26.0|-36.1|0.7491
71655309|NCT00986180|142829069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|29.03||0.6897|TWO_SIDED|95.0|-68.6|45.4|||ANCOVA|||||45.4|-68.6|0.6897
71655310|NCT00986180|142829070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|7.02||0.8226|TWO_SIDED|95.0|-12.2|15.4|||ANCOVA|||||15.4|-12.2|0.8226
71655311|NCT00986180|142829071|SUPERIORITY_OR_OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.8880
71655312|NCT00986180|142829072|SUPERIORITY_OR_OTHER|||||||0.4115|||||||Wilcoxon (Mann-Whitney)|||||||0.4115
71655313|NCT00986180|142829073|SUPERIORITY_OR_OTHER|||||||0.8495|||||||Wilcoxon (Mann-Whitney)|||||||0.8495
71655314|NCT00986180|142829074|SUPERIORITY_OR_OTHER|||||||0.7846|||||||Wilcoxon (Mann-Whitney)|||||||0.7846
71655315|NCT00986180|142829075|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.4790
71655316|NCT00986180|142829076|SUPERIORITY_OR_OTHER|||||||0.3147|||||||Wilcoxon (Mann-Whitney)|||||||0.3147
71655317|NCT00986180|142829077|SUPERIORITY_OR_OTHER|||||||0.5411|||||||Wilcoxon (Mann-Whitney)|||||||0.5411
71655318|NCT00986180|142829078|SUPERIORITY_OR_OTHER|||||||0.6137|||||||Wilcoxon (Mann-Whitney)|||||||0.6137
71655319|NCT00986180|142829079|SUPERIORITY_OR_OTHER|||||||0.7246|||||||Wilcoxon (Mann-Whitney)|||||||0.7246
71655320|NCT00986180|142829080|SUPERIORITY_OR_OTHER|||||||0.4882|||||||Wilcoxon (Mann-Whitney)|||||||0.4882
71655321|NCT00986180|142829081|SUPERIORITY_OR_OTHER|||||||0.7201|||||||Cochran-Mantel-Haenszel|||||||0.7201
71655322|NCT00986180|142829083|SUPERIORITY_OR_OTHER|||||||0.5208|||||||Cochran-Mantel-Haenszel|||||||0.5208
71708905|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0000
71708906|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the frequency of smoothness of Labia Minora among patients from different groups?||||||0.0024|||||||Chi-squared|||"Parameter: The frequency of smoothness of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0024
71708907|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of smoothness of the Posterior Commissure among patients from different groups?||||||0.0205|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."||||0.0205
71708908|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.0158|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.0158
71708909|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0001
71708910|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.028|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.0280
71708911|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708912|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708913|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708914|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708915|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0000
71708916|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin.||||0.0000
71826570|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||TWO_SIDED|99.8|0.7|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.31|0.7|
71826571|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.71|1.4||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.4|0.71|
71826572|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.89|||||TWO_SIDED|99.8|0.6|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.31|0.6|
71826573|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.23|||||TWO_SIDED|99.8|0.87|1.75||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.75|0.87|
71826574|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.97|||||TWO_SIDED|99.8|0.66|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.44|0.66|
71655323|NCT00986180|142829085|SUPERIORITY_OR_OTHER|||||||0.0401|||||||Cochran-Mantel-Haenszel|||||||0.0401
71655324|NCT00986180|142829087|SUPERIORITY_OR_OTHER|||||||0.4679|||||||Cochran-Mantel-Haenszel|||||||0.4679
71655325|NCT00986180|142829089|SUPERIORITY_OR_OTHER|||||||0.1454|||||||Fisher Exact|||||||0.1454
71655326|NCT00986180|142829090|SUPERIORITY_OR_OTHER|||||||0.1541|||||||Fisher Exact|||||||0.1541
71655327|NCT00986180|142829092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.92|2.06|||Cochran-Mantel-Haenszel|||||2.06|0.92|
71655328|NCT00986180|142829093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|1.17|2.57|||Cochran-Mantel-Haenszel|||||2.57|1.17|
71655329|NCT00986180|142829094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|1.45|8.11|||Cochran-Mantel-Haenszel|||||8.11|1.45|
71655330|NCT00986180|142829095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.67|||Cochran-Mantel-Haenszel|||||1.67|0.54|
71655331|NCT00986180|142829096|SUPERIORITY_OR_OTHER|||||||0.5828|||||||Log Rank|||||||0.5828
71655332|NCT00986180|142829097|SUPERIORITY_OR_OTHER|||||||0.9084|||||||Log Rank|||||||0.9084
71655333|NCT01765582|142829098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.132|TWO_SIDED|90.0|0.96|2.71|||Cochran-Mantel-Haenszel|||Stratified by extent of metastatic disease (liver-limited disease versus non liver-limited disease) and tumor location (right versus left) after correction post-randomization.||2.71|0.96|0.132
71826575|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.9|||||TWO_SIDED|99.8|0.67|1.21||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.||1.21|0.67|
71655334|NCT01765582|142829099|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.005|TWO_SIDED|90.0|0.53|0.88|||Log Rank|||Stratified by extent of metastatic disease (liver-limited disease vs. non-liver-limited disease) and tumor location (right vs. left) after correction post-randomization.||0.88|0.53|0.005
71655335|NCT03261960|142829135|NON_INFERIORITY|Non-inferiority margin was set at 10%.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71655336|NCT00076804|142829154|SUPERIORITY_OR_OTHER|||||||0.42||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.42
71655337|NCT00076804|142829155|SUPERIORITY_OR_OTHER|||||||0.89||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.89
71708917|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin.||||0.0006
71708918|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
71708919|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0.0003|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0003
71708920|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.||||0.0000
71708921|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.3053|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis.||||0.3053
71708922|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.7758|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.7758
71708923|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.6676|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.6676
71708924|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.4577|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis.||||0.4577
71708925|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.1681|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.1681
71708926|NCT02732145|142935188|SUPERIORITY|Question: Is there a difference in the incidence of specific lesion of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.8848|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.||||0.8848
71708927|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708928|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."||||0.0000
71708929|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708930|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708931|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708932|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening among the patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71826576|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||TWO_SIDED|99.8|0.76|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.||1.32|0.76|
71826577|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.66|1.14||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.||1.14|0.66|
71708933|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708934|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708935|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708936|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708937|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708938|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Hymenal Remnants among patients from different groups?||||||0.0001|||||||Chi-squared|||"Parameter: The incidence of erythema of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0001
71708939|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of Bartholin's Gland Opening among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708940|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of erythema of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708941|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Clitoris among patients from different groups?||||||0.0023|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0023
71708942|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708943|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of smoothness of the Urethral Meatus among patients from different groups?||||||0.0235|||||||Chi-squared|||"Parameter: The incidence of smoothness of Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0235
71708944|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Clitoris among patients from different groups?||||||0.0021|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0021
71708945|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708946|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Urethral Meatus among patients from different groups?||||||0.0038|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0038
71708947|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of ischemia of the Vestibule among patients from different groups?||||||0.0019|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0019
71708948|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0000
71708949|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of punctuation of the Vestibule among patients from different groups?||||||0.0198|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0198
71708950|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of Hart's Line among patients from different groups?||||||0.0004|||||||Chi-squared|||"Parameter: The incidence of papillae of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0004
71708951|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of papillae of the Vestibule among patients from different groups?||||||0.0053|||||||Chi-squared|||"Parameter: The incidence of papillae of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."||||0.0053
71708952|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0010
71708953|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.0010
71708954|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
71708955|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
71708956|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
71708957|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0208
71708958|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
71708959|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.004|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0040
71708960|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0012|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0012
71708961|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0000
71708962|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
71708963|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
71708964|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0048
71826578|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.28|||||TWO_SIDED|99.8|0.83|1.97||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.||1.97|0.83|
71826579|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.8|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.||1.31|0.8|
71886670|NCT02475655|143293588|SUPERIORITY||Mean Difference (Net)|-0.73||||0.09|TWO_SIDED|90.0|-1.42|-0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 12.||-0.03|-1.42|0.09
71655338|NCT00076804|142829156|SUPERIORITY_OR_OTHER|||||||0.14||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.14
71655339|NCT00076804|142829157|SUPERIORITY_OR_OTHER|||||||0.61||||||Logistic regression analysis \& Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier||||0.61
71655340|NCT02701413|142829165|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71655341|NCT02701413|142829169|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71655342|NCT00472797|142829179|SUPERIORITY_OR_OTHER||mean|2.73|||<|0.001||97.5|2.73|2.73||P-Value denotes percent change from baseline to week 12 for all combined subjects.|t-test, 1 sided|||A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.||2.73|2.73|<0.001
71655343|NCT00472797|142829180|SUPERIORITY_OR_OTHER|||||||0.466||||||P-value denotes difference between treatment groups|ANOVA|||||||0.466
71708965|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0007
71765300|NCT03745820|143032942|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.017|=|0.5537|TWO_SIDED|95.0|-5.18|2.79||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.79|-5.18|=0.5537
71655344|NCT00472797|142829180|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||<0.001
71655345|NCT00472797|142829180|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided|||||||0.003
71886671|NCT02475655|143293589|SUPERIORITY||Mean Difference (Net)|-5.4|||<|0.001|TWO_SIDED|90.0|-7.29|-3.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 5.||-3.50|-7.29|<0.001
71708966|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0131|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0131
71708967|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia?||||||0.0423|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0423
71708968|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0021|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."||||0.0021
71708969|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin.||||0.0000
71708970|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin.||||0.0000
71708971|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0091|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0091
71708972|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0002
71708973|NCT02732145|142935189|EQUIVALENCE|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
71708974|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0013|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0013
71708975|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.||||0.0001
71708976|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.||||0.0000
71708977|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.||||0.0008
71708978|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0251|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0251
71708979|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.||||0.0006
71708980|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.0211|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis.||||0.0211
71708981|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.3067|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.||||0.3067
71886672|NCT02475655|143293589|SUPERIORITY||Mean Difference (Net)|-1.23||||0.11|TWO_SIDED|90.0|-2.51|0.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 12.||0.05|-2.51|0.11
71708982|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis.||||0.0295
71708983|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0149|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis.||||0.0149
71708984|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.||||0.0007
71708985|NCT02732145|142935189|SUPERIORITY|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis.||||0.0295
71708986|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening between patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening between patients from different groups, with positive AWR.||||0.0000
71708987|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of coarse AWR between patients from different groups and positive AWR?||||||0.0071|||||||Chi-squared|||Parameter: The difference in the incidence of coarse AWR between patients from different groups and positive AWR.||||0.0071
71708988|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of slow AWR between patients from different groups and positive AWR?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of slow AWR occurrence between patients from different groups and positive AWR.||||0.0010
71708989|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of provoked erythema among patients from different groups and positive AWR?||||||0.0036|||||||Chi-squared|||Parameter: The difference in the incidence of provoked erythema among patients from different groups and positive AWR.||||0.0036
71708990|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR.||||0.0032
71708991|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
71708992|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
71708993|NCT02732145|142935190|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR.||||0.0000
71708994|NCT02732145|142935190|EQUIVALENCE|"Question: Is there a difference in the incidence of Ring sign between the patients from different groups and positive AWR?"||||||0|||||||Chi-squared|||"Parameter: The difference in the incidence of Ring sign, aceto-whitening of all structures of the Inner Vulvar Ring, between the patients from different groups and positive AWR."||||0.0000
71708995|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0856|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0856
71708996|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.4290
71708997|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0124|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.||||0.0124
71708998|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
71708999|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.0000
71826580|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.92|||||TWO_SIDED|99.8|0.69|1.22||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.||1.22|0.69|
71826581|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.95|||||TWO_SIDED|99.8|0.68|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.||1.32|0.68|
71826582|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.88|||||TWO_SIDED|99.8|0.6|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.||1.27|0.6|
71826583|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||TWO_SIDED|99.8|0.72|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.||1.44|0.72|
71826584|NCT01235949|143158016|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||TWO_SIDED|99.8|0.58|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.||1.27|0.58|
71826585|NCT01235949|143158017|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.94|||||TWO_SIDED|99.8|0.69|1.28||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.28|0.69|
71826586|NCT01235949|143158017|NON_INFERIORITY|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (\<) 1 for protein D.|GMC ratio|0.87|||||TWO_SIDED|99.8|0.64|1.17||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.||1.17|0.64|
71709000|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.||||0.1918
71709001|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
71709002|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.0000
71826587|NCT00383188|143158053|SUPERIORITY||Difference in percentage|8.05|STANDARD_ERROR_OF_MEAN|7.97||0.3131|TWO_SIDED|95.0|-7.565|23.664|||Chi-squared|||||23.664|-7.565|0.3131
71826588|NCT00383188|143158053|SUPERIORITY||Difference in percentage|10.81|STANDARD_ERROR_OF_MEAN|7.86||0.1719|TWO_SIDED|95.0|-4.602|26.224|||Chi-squared|||||26.224|-4.602|0.1719
71709003|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0.5822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.||||0.5822
71826589|NCT00383188|143158053|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|95.0|-8.123|27.799|||Chi-squared|||||27.799|-8.123|0.2783
71826590|NCT00383188|143158053|SUPERIORITY||Difference in percentage|8.92|STANDARD_ERROR_OF_MEAN|9.43||0.3381|TWO_SIDED|95.0|-9.566|27.404|||Chi-squared|||||27.404|-9.566|0.3381
71826591|NCT00383188|143158054|SUPERIORITY||Difference in percentage|1.04|STANDARD_ERROR_OF_MEAN|5.96||0.8619|TWO_SIDED|90.0|-8.733|10.845|||Chi-squared|||Week 1||10.845|-8.733|0.8619
71826592|NCT00383188|143158054|SUPERIORITY||Difference in percentage|7.24|STANDARD_ERROR_OF_MEAN|6.33||0.2546|TWO_SIDED|90.0|-3.176|17.651|||Chi-squared|||Week 1||17.651|-3.176|0.2546
71826593|NCT00383188|143158054|SUPERIORITY||Difference in percentage|14.02|STANDARD_ERROR_OF_MEAN|7.96||0.0644|TWO_SIDED|90.0|0.921|27.115|||Chi-squared|||Week 1||27.115|0.921|0.0644
71826594|NCT00383188|143158054|SUPERIORITY||Difference in percentage|1.5|STANDARD_ERROR_OF_MEAN|7.07||0.8304|TWO_SIDED|90.0|-10.13|13.125|||Chi-squared|||Week 1||13.125|-10.13|0.8304
71826595|NCT00383188|143158054|SUPERIORITY||Difference in percentage|6.11|STANDARD_ERROR_OF_MEAN|7.45||0.4123|TWO_SIDED|90.0|-6.15|18.371|||Chi-squared|||Week 2||18.371|-6.150|0.4123
71826596|NCT00383188|143158054|SUPERIORITY||Difference in percentage|5.41|STANDARD_ERROR_OF_MEAN|7.29||0.4591|TWO_SIDED|90.0|-6.581|17.392|||Chi-squared|||Week 2||17.392|-6.581|0.4591
71826597|NCT00383188|143158054|SUPERIORITY||Difference in percentage|16.58|STANDARD_ERROR_OF_MEAN|8.93||0.0585|TWO_SIDED|90.0|1.89|31.28|||Chi-squared|||Week 2||31.280|1.890|0.0585
71826598|NCT00383188|143158054|SUPERIORITY||Difference in percentage|15.68|STANDARD_ERROR_OF_MEAN|9.21||0.0808|TWO_SIDED|90.0|0.522|30.829|||Chi-squared|||Week 2||30.829|0.522|0.0808
71826599|NCT00383188|143158054|SUPERIORITY||Difference in percentage|4.86|STANDARD_ERROR_OF_MEAN|7.62||0.524|TWO_SIDED|90.0|-7.684|17.398|||Chi-squared|||Week 4||17.398|-7.684|0.5240
71709004|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
71826600|NCT00383188|143158054|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.72||0.0571|TWO_SIDED|90.0|2.172|27.588|||Chi-squared|||Week 4||27.588|2.172|0.0571
71709005|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.0000
71709006|NCT02732145|142935190|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0.4975|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR.||||0.4975
71709007|NCT02732145|142935191|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients from different groups, in which the AWR was positive?||||||0.0003|||||||ANOVA|||Parameter: The difference in the velocity of the aceto-whitening occurrence (positive AWR) among patients from different groups, in which the AWR was positive.||||0.0003
71709008|NCT02732145|142935192|EQUIVALENCE|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups?||||||0.0004|||||||Kruskal-Wallis|||Parameter: The difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups.||||0.0004
71709009|NCT02732145|142935192|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR?||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR.||||0.0231
71709010|NCT02732145|142935192|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR?||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR.||||0.0006
71709011|NCT02732145|142935192|SUPERIORITY|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR?||||||0|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR.||||0.0000
71709012|NCT02732145|142935193|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR.||||0.0000
71709013|NCT02732145|142935193|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR.||||0.0000
71709014|NCT02732145|142935193|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR.||||0.0000
71709015|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR?||||||0.0128|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR.||||0.0128
71709016|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0000
71709017|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0.0635|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR.||||0.0635
71709018|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR.||||0.0429
71709019|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR?||||||0.0011|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR.||||0.0011
71709020|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR?||||||0.0936|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR.||||0.0936
71709021|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR.||||1.0000
71826601|NCT00383188|143158054|SUPERIORITY||Difference in percentage|16.15|STANDARD_ERROR_OF_MEAN|9.08||0.0712|TWO_SIDED|90.0|1.222|31.087|||Chi-squared|||Week 4||31.087|1.222|0.0712
71826602|NCT00383188|143158054|SUPERIORITY||Difference in percentage|20.47|STANDARD_ERROR_OF_MEAN|9.43||0.0279|TWO_SIDED|90.0|4.956|35.99|||Chi-squared|||Week 4||35.990|4.956|0.0279
71765301|NCT03745820|143032942|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|2.018|=|0.332|TWO_SIDED|95.0|-5.95|2.02||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.|MMRM|||Total Score: Change From Baseline at Week 12||2.02|-5.95|=0.3320
71765302|NCT03745820|143032943|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.128|=|0.8517|TWO_SIDED|95.0|-0.23|0.28|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.28|-0.23|=0.8517
71765303|NCT03745820|143032943|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.128|=|0.9952|TWO_SIDED|95.0|-0.25|0.25|||MMRM|||A MMRM model was used to analyze the change from baseline of the OM of interest, using fixed effects of treatment group, region, study visit, study visit-by-treatment interaction, baseline value of OM, baseline-by-visit interaction.||0.25|-0.25|=0.9952
71765304|NCT01248104|143032947|SUPERIORITY_OR_OTHER_LEGACY|Continuous variables were compared by multivariate linear regression analysis to adjust for possible covariates of intraoperative fluids, age, bypass time, and procedure time. Tukey-Kramer test was then used to compare for specific differences between groups for each variable. Categorical data were compared using Fisher's exact test. All comparisons were made at a significance level of 0.05, and analysis was performed with Minitab version 17).||||||0.35||||||The primary outcome measure showed that there was no difference in PRBC transfusion frequency or amounts in the operating room or the in ICU up to POD 2|ANOVA|||A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.||||0.35
71765305|NCT01410357|143032960|SUPERIORITY|||||||0.785||||||Bonferroni corrections were conducted to adjust for multiple comparisons.|Mixed Models Analysis|||||||.785
71826603|NCT00383188|143158054|SUPERIORITY||Difference in Percentage|-2.1|STANDARD_ERROR_OF_MEAN|7.67||0.7848|TWO_SIDED|90.0|-14.71|10.515|||Chi-squared|||Week 8||10.515|-14.71|0.7848
71655346|NCT00472797|142829181|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.|t-test, 1 sided|Paired t-test for change from baseline to week 12||Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response||||<0.001
71655347|NCT00472797|142829181|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.|ANOVA|||Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.||||0.110
71655348|NCT00472797|142829182|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value refers to differneces in total score from baseline to week 12 between treatment groups.|ANOVA|||Analysis evaluates total score from baseline to week 12 for differences between each treatment group.||||0.302
71765306|NCT01410357|143032961|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.016
71765307|NCT01410357|143032962|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||<0.001
71655349|NCT00472797|142829184|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|ANOVA|||Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.||||0.899
71709022|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
71709023|NCT02732145|142935193|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR.||||0.0429
71709024|NCT02732145|142935194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR.||||0.0000
71709025|NCT02732145|142935194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR.||||0.0000
71709026|NCT02732145|142935194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR.||||0.0000
71765308|NCT01410357|143032963|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.003
71765309|NCT01410357|143032964|SUPERIORITY|||||||0.086|||||||Mixed Models Analysis|||||||.086
71765310|NCT01410357|143032965|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.872
71765311|NCT01410357|143032966|SUPERIORITY|||||||0.662|||||||Mixed Models Analysis|||||||.662
71765312|NCT01410357|143032967|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||||||.633
71765313|NCT01410357|143032968|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.175
71765314|NCT01410357|143032969|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.||||||.680
71765315|NCT01410357|143032970|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||.407
71826604|NCT00383188|143158054|SUPERIORITY||Difference in percentage|14.86|STANDARD_ERROR_OF_MEAN|7.91||0.0632|TWO_SIDED|90.0|1.86|27.869|||Chi-squared|||Week 8||27.869|1.860|0.0632
71826605|NCT00383188|143158054|SUPERIORITY||Difference in percentage|9.83|STANDARD_ERROR_OF_MEAN|9.16||0.2783|TWO_SIDED|90.0|-5.237|24.893|||Chi-squared|||Week 8||24.893|-5.237|0.2783
71826606|NCT00383188|143158054|SUPERIORITY||Difference in percentage|16.42|STANDARD_ERROR_OF_MEAN|9.55||0.0828|TWO_SIDED|90.0|0.703|32.135|||Chi-squared|||Week 8||32.135|0.703|0.0828
71826607|NCT00383188|143158054|SUPERIORITY||Difference in percentage|-2.72|STANDARD_ERROR_OF_MEAN|8.54||0.7505|TWO_SIDED|90.0|-16.77|11.328|||Chi-squared|||Week 16||11.328|-16.77|0.7505
71826608|NCT00383188|143158054|SUPERIORITY||Difference in percentage|1.43|STANDARD_ERROR_OF_MEAN|8.35||0.8641|TWO_SIDED|90.0|-12.3|15.156|||Chi-squared|||Week 16||15.156|-12.30|0.8641
71826609|NCT00383188|143158054|SUPERIORITY||Difference in percentage|3.31|STANDARD_ERROR_OF_MEAN|9.99||0.7399|TWO_SIDED|90.0|-13.12|19.734|||Chi-squared|||Week 16||19.734|-13.12|0.7399
71826610|NCT00383188|143158054|SUPERIORITY||Difference in percentage|-12.48|STANDARD_ERROR_OF_MEAN|9.42||0.1996|TWO_SIDED|90.0|-27.98|3.018|||Chi-squared|||Week 16||3.018|-27.98|0.1996
71826611|NCT00383188|143158055|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|1.48||0.2982|TWO_SIDED|90.0|-0.944|3.929|||Chi-squared|||Week 1||3.929|-0.944|0.2982
71826612|NCT00383188|143158055|SUPERIORITY||Difference in percentage|1.41|STANDARD_ERROR_OF_MEAN|1.4||0.3122|TWO_SIDED|90.0|-0.892|3.709|||Chi-squared|||Week 1||3.709|-0.892|0.3122
71826613|NCT00383188|143158055|SUPERIORITY||Difference in percentage|4.65|STANDARD_ERROR_OF_MEAN|3.21||0.0649|TWO_SIDED|90.0|-0.631|9.934|||Chi-squared|||Week 1||9.934|-0.631|0.0649
71826614|NCT00383188|143158055|SUPERIORITY||Difference in percentage|5.13|STANDARD_ERROR_OF_MEAN|3.53||0.0525|TWO_SIDED|90.0|-0.681|10.938|||Chi-squared|||Week 1||10.938|-0.681|0.0525
71826615|NCT00383188|143158055|SUPERIORITY||Difference in percentage|4.45|STANDARD_ERROR_OF_MEAN|3.12||0.1481|TWO_SIDED|90.0|-0.681|9.573|||Chi-squared|||Week 2||9.573|-0.681|0.1481
71826616|NCT00383188|143158055|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|3.66||0.0292|TWO_SIDED|90.0|2.093|14.124|||Chi-squared|||Week 2||14.124|2.093|0.0292
71826617|NCT00383188|143158055|SUPERIORITY||Difference in percentage|10.01|STANDARD_ERROR_OF_MEAN|4.97||0.0167|TWO_SIDED|90.0|1.839|18.186|||Chi-squared|||Week 2||18.186|1.839|0.0167
71826618|NCT00383188|143158055|SUPERIORITY||Difference in percentage|11.15|STANDARD_ERROR_OF_MEAN|5.4||0.011|TWO_SIDED|90.0|2.269|20.029|||Chi-squared|||Week 2||20.029|2.269|0.0110
71826619|NCT00383188|143158055|SUPERIORITY||Difference in percentage|-2.51|STANDARD_ERROR_OF_MEAN|3.31||0.455|TWO_SIDED|90.0|-7.959|2.946|||Chi-squared|||Week 4||2.946|-7.959|0.4550
71826620|NCT00383188|143158055|SUPERIORITY||Difference in percentage|8.11|STANDARD_ERROR_OF_MEAN|4.76||0.0919|TWO_SIDED|90.0|0.271|15.946|||Chi-squared|||Week 4||15.946|0.271|0.0919
71826621|NCT00383188|143158055|SUPERIORITY||Difference in percentage|12.78|STANDARD_ERROR_OF_MEAN|6.38||0.0264|TWO_SIDED|90.0|2.28|23.272|||Chi-squared|||Week 4||23.272|2.280|0.0264
71826622|NCT00383188|143158055|SUPERIORITY||Difference in percentage|12.09|STANDARD_ERROR_OF_MEAN|6.56||0.0369|TWO_SIDED|90.0|1.308|22.881|||Chi-squared|||Week 4||22.881|1.308|0.0369
71826623|NCT00383188|143158055|SUPERIORITY||Difference in percentage|-9.17|STANDARD_ERROR_OF_MEAN|4.67||0.0568|TWO_SIDED|90.0|-16.85|-1.482|||Chi-squared|||Week 8||-1.482|-16.85|0.0568
71826624|NCT00383188|143158055|SUPERIORITY||Difference in percentage|4.05|STANDARD_ERROR_OF_MEAN|5.95||0.4961|TWO_SIDED|90.0|-5.727|13.835|||Chi-squared|||Week 8||13.835|-5.727|0.4961
71826625|NCT00383188|143158055|SUPERIORITY||Difference in percentage|6.94|STANDARD_ERROR_OF_MEAN|7.26||0.3212|TWO_SIDED|90.0|-5.008|18.89|||Chi-squared|||Week 8||18.890|-5.008|0.3212
71826626|NCT00383188|143158055|SUPERIORITY||Difference in percentage|1.49|STANDARD_ERROR_OF_MEAN|6.9||0.8274|TWO_SIDED|90.0|-9.87|12.843|||Chi-squared|||Week 8||12.843|-9.870|0.8274
71826627|NCT00383188|143158055|SUPERIORITY||Difference in percentage|5.23|STANDARD_ERROR_OF_MEAN|5.94||0.3774|TWO_SIDED|90.0|-4.538|14.996|||Chi-squared|||Week 12||14.996|-4.538|0.3774
71826628|NCT00383188|143158055|SUPERIORITY||Difference in percentage|9.46|STANDARD_ERROR_OF_MEAN|6.11||0.1246|TWO_SIDED|90.0|-0.591|19.51|||Chi-squared|||Week 12||19.510|-0.591|0.1246
71826629|NCT00383188|143158055|SUPERIORITY||Difference in percentage|8.29|STANDARD_ERROR_OF_MEAN|7.17||0.2257|TWO_SIDED|90.0|-3.502|20.087|||Chi-squared|||Week 12||20.087|-3.502|0.2257
71826630|NCT00383188|143158055|SUPERIORITY||Difference in percentage|5.34|STANDARD_ERROR_OF_MEAN|7.11||0.4336|TWO_SIDED|90.0|-6.355|17.03|||Chi-squared|||Week 12||17.030|-6.355|0.4336
71826631|NCT00383188|143158055|SUPERIORITY||Difference in percentage|-2.07|STANDARD_ERROR_OF_MEAN|7.02||0.7682|TWO_SIDED|90.0|-13.61|9.467|||Chi-squared|||Week 16||9.467|-13.61|0.7682
71826632|NCT00383188|143158055|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|6.76||0.6726|TWO_SIDED|90.0|-13.97|8.257|||Chi-squared|||Week 16||8.257|-13.97|0.6726
71826633|NCT00383188|143158055|SUPERIORITY||Difference in percentage|-5.64|STANDARD_ERROR_OF_MEAN|7.68||0.4795|TWO_SIDED|90.0|-18.28|7.0|||Chi-squared|||Week 16||7.000|-18.28|0.4795
71826634|NCT00383188|143158055|SUPERIORITY||Difference in percentage|-16.17|STANDARD_ERROR_OF_MEAN|6.1||0.0276|TWO_SIDED|90.0|-26.19|-6.137|||Chi-squared|||Week 16||-6.137|-26.19|0.0276
71826635|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
71655350|NCT00472797|142829185|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 12||||<0.001
71655351|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 36||||0.234
71655352|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 1||||0.001
71655353|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 3||||0.004
71655354|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Exisit Visit LOCF||||0.036
71655355|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 12||||0.002
71655356|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 36||||0.468
71655357|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.602||95.0|||||t-test, 2 sided|Paired||Mental Component - Change from Baseline to Extension Visit 1||||0.602
71655358|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.414||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Extension Visit 3||||0.414
71709027|NCT02732145|142935194|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR.||||0.0000
71709028|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR.||||0.0318
71709029|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||0.0318
71709030|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0000
71709031|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR.||||1.0000
71709032|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
71655359|NCT00472797|142829185|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||t-test, 2 sided|Paired||Change from Baseline to Exit Visit LOCF||||0.991
71655360|NCT03399318|142829191|SUPERIORITY||||||<|0.0001||||||treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. A t-test for significance of the treatment effect, were derived from this model.|t-test, 2 sided|||The analysis of the primary outcome variable, Tmax, involved fitting an analysis of 206 covariance model with treatment group as the factor of interest, country and disease severity 207 (CM=yes, no) as stratification factors, and admission temperature as a covariate. The estimated 208 treatment effect and associated 95% confidence interval, as well as a t-test for significance of the treatment effect, were derived from this model.||||<0.0001
71655361|NCT03399318|142829192|SUPERIORITY||Odds Ratio (OR)|0.09|||<|0.05|TWO_SIDED|95.0|0.03|0.27|||Regression, Logistic|||Seizure occurrence defined as a three-level ordinal variable was analyzed using a 223 multinomial logistic regression model because there was evidence that the proportional odds 224 assumption did not hold. This model included treatment group as the factor of interest and 225 country and disease severity as stratification factors. The adjusted treatment group odds ratio, 226 and its associated 95% confidence interval were derived from this model.||.27|.03|<0.05
71655362|NCT03399318|142829193|SUPERIORITY||Odds Ratio, log|6.3|||<|0.05|TWO_SIDED|95.0|-5.1|17.7||The covariance matrix for the within-participant observations was 232 modeled using an unstructured pattern.|ANCOVA|Time to parasite clearance was 235 evaluated using a discrete-time proportional hazards model with a complementary log-log link.|The adjusted treatment group difference in mean area 233 under the log10(HRP2 level) × time curve was estimated using appropriate contrasts among the 234 treatment group means over time that quantify this comparison.|Parasite clearance measured by log10 (HRP2 level) was analyzed with a repeated 228 measures analysis of covariance model (mixed model repeated measures)35 with terms for 229 treatment group, country, disease severity, log10(HRP2 level) at admission, time (treated as a 230 categorical variable), and interaction terms for admission log10(HRP2 level) and time, and for 231 treatment group and time.|The model included terms for treatment group, country, and disease severity.|17.7|-5.1|<0.05
71655363|NCT03399318|142829194|SUPERIORITY||Odds Ratio (OR)|0.32|||<|0.05|TWO_SIDED|95.0|0.2|0.52||An ordinal logistic regression model assuming 216 proportional odds with terms for treatment group, country, and disease severity as covariates was used to derive the estimated adjusted treatment group odds ratio and 95%CI|Regression, Logistic|Sensitivity analyses with best-case and worst-case imputation were 219 performed to accommodate missing data||A secondary efficacy measure included fever exposure as measured by the area under 214 the temperature × time curve for T≥38.5°C during the 72-hour follow-up period, categorized as 215 0, \> 0 and \< 2, and ≥ 2 degree-hours.||.52|.20|<0.05
71655364|NCT03852459|142829195|SUPERIORITY|||||||0.4272|||||||ANCOVA|||||||0.4272
71655365|NCT00257920|142829205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.009||0.67||95.0|-0.023|0.015||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<= 0.050 were considered statistically significant.|Mixed Models Analysis|||The null hypothesis was that there is no difference in the mean calcium absorption fraction between Zemplar Injection and Hectorol Injection. The power calculation applied to the primary efficacy analysis.||0.015|-0.023|0.670
71655366|NCT00257920|142829206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.009||0.573||95.0|-0.024|0.014||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values \<=0.050 were considered statistically significant.|ANOVA|||The null hypothesis was that there is no difference in mean calcium absorption between Zemplar and Hectorol. Approximately 42 subjects were to be randomized assuming 36 subjects would available in the per-protocol set. A sample size of 36 subjects has 80% power to detect a mean difference of -0.018 assuming the Zemplar group mean is 0.139, the Hectorol group mean is 0.157 and the STD is 0.037. The ANOVA model included effects for sequence, subject-within-sequence, period and treatment regimen.||0.014|-0.024|0.573
71709033|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.||||0.0389
71709034|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR?||||||1e-05|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR.||||0.00001
71709035|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0000
71709036|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
71709037|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR.||||0.0008
71765316|NCT01410357|143032971|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||.870
71765317|NCT01410357|143032972|SUPERIORITY|||||||0.707|||||||Mixed Models Analysis|||||||.707
71765318|NCT01410357|143032973|SUPERIORITY|||||||0.838|||||||Mixed Models Analysis|||||||.838
71765319|NCT01410357|143032974|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
71765320|NCT01410357|143032975|SUPERIORITY|||||||0.853|||||||Mixed Models Analysis|||||||.853
71765321|NCT01410357|143032976|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||.510
71765322|NCT01410357|143032977|SUPERIORITY|||||||0.573|||||||Mixed Models Analysis|||||||.573
71765323|NCT01410357|143032978|SUPERIORITY|||||||0.758|||||||Mixed Models Analysis|||||||.758
71765324|NCT01410357|143032979|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
71765325|NCT01410357|143032980|SUPERIORITY|||||||0.156|||||||Mixed Models Analysis|||||||.156
71765326|NCT01410357|143032981|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71826636|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
71709038|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
71709039|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR.||||0.0000
71765327|NCT01410357|143032982|SUPERIORITY|||||||0.878|||||||Mixed Models Analysis|||||||.878
71765328|NCT01410357|143032983|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
71765329|NCT01410357|143032984|SUPERIORITY|||||||0.227|||||||Mixed Models Analysis|||||||.227
71765330|NCT01589653|143033001|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently when the p-value for the one-sided test of H0: D \> 0.4% against HA: D ≤ 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|Treatment difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.54|0.08|||Regression, Linear|Analyses were adjusted for treatment, strata, country and baseline HbA1c||The null-hypothesis was tested against the alternative hypothesis of non-inferiority as given by: H0: D \> 0.4% against HA: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (subject-driven titration minus investigator-driven titration).||0.08|-0.54|<0.001
71765331|NCT04250077|143033037|SUPERIORITY||proportion|0.36923076|STANDARD_ERROR_OF_MEAN|0.16518156||0.02578184|TWO_SIDED|95.0|-0.0021812|0.64531855|||Agresti Caffo proportion comparison|||||0.64531855|-0.0021812|0.02578184
71765332|NCT04250077|143033038|SUPERIORITY||Mean Difference (Net)|20.0454545|STANDARD_ERROR_OF_MEAN|7.62386242||0.00787297|TWO_SIDED|95.0|4.18213496|35.9087741|||t-test, 1 sided|||||35.9087741|4.18213496|0.00787297
71765333|NCT04250077|143033039|SUPERIORITY||Mean Difference (Net)|-39.183333|STANDARD_ERROR_OF_MEAN|15.8274398||0.01387108|TWO_SIDED|95.0|-73.356073|-5.0105927|||t-test, 1 sided|||||-5.0105927|-73.356073|0.01387108
71765334|NCT04250077|143033040|SUPERIORITY||Mean Difference (Net)|8.43728901|STANDARD_ERROR_OF_MEAN|3.28323704||0.00908118|TWO_SIDED|95.0|1.59437702|15.280201|||t-test, 1 sided|||||15.2802010|1.59437702|0.00908118
71765335|NCT04250077|143033041|SUPERIORITY||Mean Difference (Net)|1.47698833|STANDARD_ERROR_OF_MEAN|3.68529034||0.34633293|TWO_SIDED|95.0|-6.1910435|9.14502026|||t-test, 1 sided|||||9.14502026|-6.1910435|0.34633293
71765336|NCT04250077|143033042|SUPERIORITY||Mean Difference (Final Values)|-0.4285714|STANDARD_ERROR_OF_MEAN|2.07315199||0.57872623|TWO_SIDED|95.0|-5.4078121|4.55066924|||t-test, 1 sided|||||4.55066924|-5.4078121|0.57872623
71765337|NCT04250077|143033043|SUPERIORITY||Median Difference (Net)|1.29230769|STANDARD_ERROR_OF_MEAN|0.81588207||0.06283641|TWO_SIDED|95.0|-0.3873203|2.97193574|||t-test, 1 sided|||||2.97193574|-0.3873203|0.06283641
71765338|NCT04250077|143033044|SUPERIORITY||proportion|0.11794871|STANDARD_ERROR_OF_MEAN|0.16796576||0.26422281|TWO_SIDED|95.0|-0.2233244|0.43508919|||Agresti Caffo proportion comparison|||||0.43508919|-0.2233244|0.26422281
71826637|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
71826638|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 1||0.00|0.00|0.000
71709040|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR.||||0.0005
71826639|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
71826640|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|0.0||0|TWO_SIDED|90.0|0.0|0.0|||Chi-squared|||Week 2||0.00|0.00|0.000
71709041|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.0000
71709042|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
71709043|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0.4505|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR.||||0.4505
71709044|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
71709045|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.||||0.0000
71826641|NCT00383188|143158056|SUPERIORITY||Difference in percentage|2.27|STANDARD_ERROR_OF_MEAN|2.25||0.1928|TWO_SIDED|90.0|-1.423|5.968|||Chi-squared|||Week 2||5.968|-1.423|0.1928
71826642|NCT00383188|143158056|SUPERIORITY||Difference in percentage|2.5|STANDARD_ERROR_OF_MEAN|2.47||0.1719|TWO_SIDED|90.0|-1.56|6.56|||Chi-squared|||Week 2||6.560|-1.560|0.1719
71826643|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.1|STANDARD_ERROR_OF_MEAN|1.97||0.9603|TWO_SIDED|90.0|-3.138|3.334|||Chi-squared|||Week 4||3.334|-3.138|0.9603
71709046|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR.||||1.0000
71709047|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
71709048|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
71709049|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR.||||0.0534
71709050|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0000
71709051|NCT02732145|142935194|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR.||||0.0005
71826644|NCT00383188|143158056|SUPERIORITY||Difference in percentage|-1.35|STANDARD_ERROR_OF_MEAN|1.34||0.3157|TWO_SIDED|90.0|-3.559|0.856|||Chi-squared|||Week 4||0.856|-3.559|0.3157
71826645|NCT00383188|143158056|SUPERIORITY||Difference in percentage|5.47|STANDARD_ERROR_OF_MEAN|4.03||0.1125|TWO_SIDED|90.0|-1.162|12.096|||Chi-squared|||Week 4||12.096|-1.162|0.1125
71826646|NCT00383188|143158056|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|3.7||0.2455|TWO_SIDED|90.0|-2.434|9.732|||Chi-squared|||Week 4||9.732|-2.434|0.2455
71826647|NCT00383188|143158056|SUPERIORITY||Difference in percentage|-2.6|STANDARD_ERROR_OF_MEAN|2.71||0.3452|TWO_SIDED|90.0|-7.057|1.847|||Chi-squared|||Week 8||1.847|-7.057|0.3452
71826648|NCT00383188|143158056|SUPERIORITY||Difference in percentage|0.0|STANDARD_ERROR_OF_MEAN|3.24||1|TWO_SIDED|90.0|-5.333|5.333|||Chi-squared|||Week 8||5.333|-5.333|1.0000
71826649|NCT00383188|143158056|SUPERIORITY||Difference in percentage|7.31|STANDARD_ERROR_OF_MEAN|5.31||0.1267|TWO_SIDED|90.0|-1.417|16.036|||Chi-squared|||Week 8||16.036|-1.417|0.1267
71826650|NCT00383188|143158056|SUPERIORITY||Difference in percentage|5.95|STANDARD_ERROR_OF_MEAN|5.27||0.2069|TWO_SIDED|90.0|-2.72|14.612|||Chi-squared|||Week 8||14.612|-2.720|0.2069
71826651|NCT00383188|143158056|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.08||0.6506|TWO_SIDED|90.0|-4.871|8.553|||Chi-squared|||Week 12||8.553|-4.871|0.6506
71826652|NCT00383188|143158056|SUPERIORITY||Difference in percentage|2.7|STANDARD_ERROR_OF_MEAN|4.12||0.5125|TWO_SIDED|90.0|-4.075|9.48|||Chi-squared|||Week 12||9.480|-4.075|0.5125
71826653|NCT00383188|143158056|SUPERIORITY||Difference in percentage|3.69|STANDARD_ERROR_OF_MEAN|5.07||0.4412|TWO_SIDED|90.0|-4.652|12.023|||Chi-squared|||Week 12||12.023|-4.652|0.4412
71709052|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR.||||0.0000
71709053|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR.||||0.0000
71709054|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR.||||0.0000
71709055|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR.||||0.0000
71765339|NCT00647270|143033046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.074|TWO_SIDED|95.0|-13.3|7.4|||Chi-squared||Treatment difference between adalimumab 80 mg monthly and placebo divided by the difference between adalimumab 40 mg eow and placebo.|Adalimumab 80 mg monthly versus placebo: The null hypothesis associated with this comparison stated that adalimumab 80 mg monthly would be inferior to placebo with respect to ACR20 response percentage; the alternative hypothesis was that adalimumab 80 mg monthly would be superior to placebo with respect to ACR20 response.||7.4|-13.3|0.074
71826654|NCT00383188|143158056|SUPERIORITY||Difference in percentage|2.09|STANDARD_ERROR_OF_MEAN|4.92||0.6566|TWO_SIDED|90.0|-6.006|10.195|||Chi-squared|||Week 12||10.195|-6.006|0.6566
71826655|NCT00383188|143158056|SUPERIORITY||Difference in percentage|-5.16|STANDARD_ERROR_OF_MEAN|4.5||0.2634|TWO_SIDED|90.0|-12.57|2.247|||Chi-squared|||Week 16||2.247|-12.57|0.2634
71826656|NCT00383188|143158056|SUPERIORITY||Difference in percentage|-2.86|STANDARD_ERROR_OF_MEAN|4.73||0.546|TWO_SIDED|90.0|-10.63|4.916|||Chi-squared|||Week 16||4.916|-10.63|0.5460
71826657|NCT00383188|143158056|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
71826658|NCT00383188|143158056|SUPERIORITY||Difference in percentage|-7.37|STANDARD_ERROR_OF_MEAN|4.43||0.1626|TWO_SIDED|90.0|-14.65|-0.086|||Chi-squared|||Week 16||-0.086|-14.65|0.1626
71826659|NCT00383188|143158057|SUPERIORITY||Least Square Mean (LSM) Difference|-0.388|STANDARD_ERROR_OF_MEAN|1.025||0.7053|TWO_SIDED|95.0|-2.4|1.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.624|-2.400|0.7053
71826660|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.312|STANDARD_ERROR_OF_MEAN|1.009||0.1938|TWO_SIDED|95.0|-3.291|0.668|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.668|-3.291|0.1938
71826661|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.187|STANDARD_ERROR_OF_MEAN|1.174||0.0627|TWO_SIDED|95.0|-4.491|0.116|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.116|-4.491|0.0627
71709056|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR.||||0.0000
71709057|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR.||||0.0000
71709058|NCT02732145|142935195|EQUIVALENCE|Question: Is there a difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR.||||0.0000
71709059|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR?||||||0.8545|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR.||||0.8545
71709060|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.8569|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.8569
71709061|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.2478
71709062|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.2478
71826662|NCT00383188|143158057|SUPERIORITY||LSM Difference|-0.851|STANDARD_ERROR_OF_MEAN|1.206||0.4809|TWO_SIDED|95.0|-3.218|1.517|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.517|-3.218|0.4809
71826663|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.289|STANDARD_ERROR_OF_MEAN|1.017||0.2057|TWO_SIDED|95.0|-3.286|0.709|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.709|-3.286|0.2057
71655367|NCT03456960|142829225|EQUIVALENCE|The difference in the least square means (LSM) between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0059|||||TWO_SIDED|90.0|-0.034|0.0458||||||||0.0458|-0.0340|
71655368|NCT03456960|142829226|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0508|||||TWO_SIDED|90.0|-0.0079|0.1096||||||||0.1096|-0.0079|
71655369|NCT03456960|142829227|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0546|||||TWO_SIDED|90.0|-0.0941|0.2034||||||||0.2034|-0.0941|
71655370|NCT03456960|142829227|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model will include a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0912|||||TWO_SIDED|90.0|0.0399|0.1424||||||||0.1424|0.0399|
71655371|NCT03456960|142829228|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0916|||||TWO_SIDED|90.0|-0.133|0.3162||||||||0.3162|-0.1330|
71655372|NCT03456960|142829228|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.2293|||||TWO_SIDED|90.0|0.1519|0.3068||||||||0.3068|0.1519|
71655373|NCT03456960|142829229|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.01|||||TWO_SIDED|90.0|-0.0299|0.05||||||||0.0500|-0.0299|
71655374|NCT03456960|142829230|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0281|||||TWO_SIDED|90.0|-0.1662|0.11||||||||0.1100|-0.1662|
71655375|NCT03456960|142829231|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.015|||||TWO_SIDED|90.0|-0.0448|0.0149||||||||0.0149|-0.0448|
71655376|NCT03456960|142829232|EQUIVALENCE|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0195|||||TWO_SIDED|90.0|-0.0676|0.0286||||||||0.0286|-0.0676|
71655377|NCT03456960|142829233|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0547|||||TWO_SIDED|90.0|-0.0937|0.2032||||||||0.2032|-0.0937|
71655378|NCT03456960|142829233|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0654|||||TWO_SIDED|90.0|0.0141|0.1167||||||||0.1167|0.0141|
71655379|NCT03456960|142829234|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.146|||||TWO_SIDED|90.0|-0.2478|-0.0443||||||||-0.0443|-0.2478|
71655380|NCT03456960|142829234|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1674|||||TWO_SIDED|90.0|-0.2084|-0.1264||||||||-0.1264|-0.2084|
71709063|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
71709064|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.5943|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.5943
71655381|NCT03456960|142829235|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1193|||||TWO_SIDED|90.0|-0.2179|-0.0206||||||||-0.0206|-0.2179|
71655382|NCT03456960|142829235|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1366|||||TWO_SIDED|90.0|-0.173|-0.1002||||||||-0.1002|-0.1730|
71709065|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.7161|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.||||0.7161
71709066|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.3301
71709067|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.3301
71709068|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.||||0.1627
71709069|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.4742|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.4742
71765340|NCT00647270|143033046|NON_INFERIORITY_OR_EQUIVALENCE|A sensitivity analysis was proposed for the non-inferiority comparison. If the lower confidence limit of θ80 - θ40 was greater than -0.1, then the non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg eow would be claimed||||||0.74||95.0||||Non - inferiority of adalimumab 80 mg monthly compared with 40 mg eow could not be tested because the null hypothesis of the first comparison was not rejected.|Chi-squared|||The non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg every other week (eow) was to be claimed if at least 50% of the treatment effect of adalimumab 40 mg eow over placebo was to be achieved by adalimumab 80 mg monthly over placebo.||||0.74
71765341|NCT00647270|143033047|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
71826664|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.331|STANDARD_ERROR_OF_MEAN|0.999||0.1833|TWO_SIDED|95.0|-3.293|0.631|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.631|-3.293|0.1833
71709070|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.||||0.1822
71709071|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.||||0.1822
71709072|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.0927|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0927
71709073|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.036|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR.||||0.0360
71826665|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.748|STANDARD_ERROR_OF_MEAN|1.166||0.0187|TWO_SIDED|95.0|-5.037|-0.459|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.459|-5.037|0.0187
71826666|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.345|STANDARD_ERROR_OF_MEAN|1.197||0.2615|TWO_SIDED|95.0|-3.695|1.005|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.005|-3.695|0.2615
71709074|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR.||||0.0720
71709075|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||1.0000
71709076|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
71709077|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
71709078|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.5987|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.5987
71765342|NCT00647270|143033048|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
71826667|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.764|STANDARD_ERROR_OF_MEAN|1.017||0.0832|TWO_SIDED|95.0|-3.761|0.233|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.233|-3.761|0.0832
71765343|NCT00647270|143033048|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
71826668|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.615|STANDARD_ERROR_OF_MEAN|0.999||0.1066|TWO_SIDED|95.0|-3.576|0.347|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.347|-3.576|0.1066
71709079|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR?||||||0.4164|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR.||||0.4164
71709080|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR.||||0.0720
71709081|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.0148|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.0148
71709082|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.0085|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.0085
71709083|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.||||0.1918
71709084|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR?||||||0.3037|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR.||||0.3037
71709085|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR.||||0.4833
71709086|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR.||||0.3594
71709087|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR?||||||0.0877|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR.||||0.0877
71709088|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR?||||||0.7726|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR.||||0.7726
71709089|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR?||||||0.0191|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR.||||0.0191
71765344|NCT00647270|143033049|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The ANCOVA Model was adjusted for the Baseline Measure.|ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.002
71765345|NCT00647270|143033050|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The ANCOVA Model was adjusted for Baseline Measure.|ANCOVA|The ANCOVA Model was adjusted for Baseline Measure.||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value \> 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.||||0.005
71765346|NCT01743001|143033065|SUPERIORITY||least-square (LS) mean difference|-4.7||||0.612|TWO_SIDED|95.0|-22.8|13.5||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically according to order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model included treatment group, presence of DS (yes/no), and WHO FC (II vs III/IV) as categorical factors, and baseline 6MWD value as covariate||The null hypothesis was that there was no difference between macitentan and placebo for the mean change from baseline to Week 16 in 6MWD. Null hypothesis was tested by an analysis of covariance (ANCOVA).||13.5|-22.8|0.6120
71765347|NCT01743001|143033066|SUPERIORITY||Odds Ratio (OR)|0.53||||0.145|TWO_SIDED|95.0|0.23|1.24||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|Regression, Logistic|Logistic regression model adjusted for randomized treatment group and location of cardiac defect (pre-tricupsid / post-tricupsid ) as factors.||For this secondary endpoint of WHO functional class, the improvement from baseline to Week 16 in WHO functional class was evaluated. The null hypothesis is the odds of improvement are the same in the placebo and the macitentan group.||1.24|0.23|0.1450
71765348|NCT01743001|143033067|SUPERIORITY||least-square (LS) mean difference|0.08||||0.6818||95.0|-0.29|0.44||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|ANCOVA|Adjusted for randomized treatment group, location of cardiac defect(pre-tricupsid/post-tricupsid) as factors, baseline Borg dyspnea index as covariate||The null hypothesis was that the mean change from baseline to Week 16 in the Borg dyspnea index is the same in the macitentan and in the placebo group.||0.44|-0.29|0.6818
71826669|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.406|STANDARD_ERROR_OF_MEAN|1.166||0.0394|TWO_SIDED|95.0|-4.695|-0.118|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.118|-4.695|0.0394
71709090|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.0287
71709091|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.6374|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.6374
71709092|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.7512|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.7512
71709093|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2734|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2734
71709094|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0287
71709095|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.||||0.8732
71709096|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0602|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0602
71826670|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.355|STANDARD_ERROR_OF_MEAN|1.197||0.258|TWO_SIDED|95.0|-3.705|0.995|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.995|-3.705|0.2580
71709097|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0079|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0079
71709098|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2081|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.||||0.2081
71709099|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.8732
71709100|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0852|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.||||0.0852
71709101|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.||||0.0125
71709102|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.0125
71709103|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.2714|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR.||||0.2714
71709104|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR.||||0.1692
71709105|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.0772|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.0772
71709106|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.5762
71709107|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.5762
71765349|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-1.0||||0.6431|TWO_SIDED|95.0|-5.0|3.1|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning.||3.1|-5.0|0.6431
71765350|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.5988|TWO_SIDED|95.0|-6.7|3.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical.||3.9|-6.7|0.5988
71765351|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-5.9|6.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index.||6.2|-5.9|0.9642
71765352|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|3.1||||0.1542|TWO_SIDED|95.0|-1.2|7.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions.||7.3|-1.2|0.1542
71826671|NCT00383188|143158057|SUPERIORITY||LSM Difference|-0.758|STANDARD_ERROR_OF_MEAN|1.017||0.456|TWO_SIDED|95.0|-2.754|1.238|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.238|-2.754|0.4560
71709108|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||1.0000
71709109|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
71709110|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.6862|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR.||||0.6862
71709111|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0563
71709112|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0563
71709113|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.||||0.1692
71709114|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR?||||||0.1822|||||||t|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR.||||0.1822
71709115|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR.||||0.0220
71826672|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.021|STANDARD_ERROR_OF_MEAN|0.999||0.0434|TWO_SIDED|95.0|-3.982|-0.06|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.060|-3.982|0.0434
71709116|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR.||||0.0220
71709117|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR.||||0.0220
71709118|NCT02732145|142935195|SUPERIORITY|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR.||||0.0078
71709119|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of hyperkeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperkeratosis in vulvar specimens of patients from different groups.||||0.0000
71709120|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of parakeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of parakeratosis in vulvar specimens of patients from different groups.||||0.0000
71709121|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of acanthosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of acanthosis in vulvar specimens of patients from different groups.||||0.0000
71709122|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of epidermal atrophy in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of epidermal atrophy in vulvar specimens of patients from different groups.||||0.0000
71826673|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.728|STANDARD_ERROR_OF_MEAN|1.165||0.1386|TWO_SIDED|95.0|-4.016|0.56|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.560|-4.016|0.1386
71709123|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
71826674|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.154|STANDARD_ERROR_OF_MEAN|1.197||0.3353|TWO_SIDED|95.0|-3.503|1.196|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.196|-3.503|0.3353
71886673|NCT02475655|143293590|SUPERIORITY||Mean Difference (Net)|-1.54||||0.26|TWO_SIDED|90.0|-3.78|0.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 5.||0.70|-3.78|0.26
71709124|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups.||||0.0000
71709125|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of lymphocytes in vulvar specimens of patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes (infiltrates) in vulvar specimens of patients from different groups.||||0.0105
71709126|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of mastocytes in vulvar specimens of patients from different groups?||||||0.0064|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mastocytes in vulvar specimens of patients from different groups.||||0.0064
71709127|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of collagen fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens of patients from different groups.||||0.0000
71709128|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of hyalinization in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens of patients from different groups.||||0.0000
71709129|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of hyperpigmentation in vulvar specimens of patients from different groups?||||||0.0342|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperpigmentation in vulvar specimens of patients from different groups.||||0.0342
71709130|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of elongated dermal papillae in vulvar specimens of patients from different groups?||||||0.0148|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of elongated dermal papillae in vulvar specimens of patients from different groups.||||0.0148
71709131|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of blood vessels in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens of patients from different groups.||||0.0000
71709132|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens of patients from different groups.||||0.0000
71709133|NCT02732145|142935196|EQUIVALENCE|Question: Is there a difference in the incidence of nerve fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens of patients from different groups.||||0.0000
71709134|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0000
71709135|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||1|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||1.0000
71709136|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.3533|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.3533
71765353|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|1.1||||0.602|TWO_SIDED|95.0|-3.1|5.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality.||5.3|-3.1|0.6020
71765354|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-1.4||||0.634|TWO_SIDED|95.0|-7.2|4.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning.||4.4|-7.2|0.6340
71709137|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.5641|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.5641
71709138|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9684|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9684
71709139|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8599|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8599
71826675|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.016||0.041|TWO_SIDED|95.0|-4.075|-0.085|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.085|-4.075|0.0410
71709140|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
71709141|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8389|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8389
71709142|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.7617|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.7617
71709143|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of the sharp pain of the vulva depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.4613|||||||Chi-squared|||Parameter: The difference in the incidence of the sharp (fast) pain of the vulva (knife-like pain, paper-cuts pain, stabbing, sticking) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.4613
71709144|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.0331|||||||Chi-squared, Corrected|||Parameter: The incidence of the vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.0331
71709145|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of the vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9402
71709146|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9139|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.9139
71709147|NCT02732145|142935197|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8925|||||||Chi-squared|||Parameter: The incidence of the vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.||||0.8925
71709148|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0000
71709149|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the dull pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6921|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6921
71709150|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar burning on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.1848|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.1848
71765355|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-2.8||||0.3384|TWO_SIDED|95.0|-8.7|3.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional.||3.0|-8.7|0.3384
71765356|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-2.3||||0.2704|TWO_SIDED|95.0|-6.4|1.8|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.8|-6.4|0.2704
71765357|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-0.4||||0.6431|TWO_SIDED|95.0|-2.1|1.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning (norm-based).||1.3|-2.1|0.6431
71826676|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.234|STANDARD_ERROR_OF_MEAN|0.998||0.0255|TWO_SIDED|95.0|-4.194|-0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.274|-4.194|0.0255
71826677|NCT00383188|143158057|SUPERIORITY||LSM Difference|-2.384|STANDARD_ERROR_OF_MEAN|1.165||0.041|TWO_SIDED|95.0|-4.671|-0.097|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||-0.097|-4.671|0.0410
71826678|NCT00383188|143158057|SUPERIORITY||LSM Difference|-1.911|STANDARD_ERROR_OF_MEAN|1.196||0.1106|TWO_SIDED|95.0|-4.259|0.438|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.438|-4.259|0.1106
71709151|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.9048|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.9048
71709152|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3953|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3953
71709153|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0921|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0921
71709154|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6734|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6734
71709155|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3458|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.3458
71709156|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.5304|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.5304
71709157|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of symptoms of the sharp pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0012|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp (fast) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0012
71709158|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0002|||||||Chi-squared|||Parameter: The incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0002
71709159|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0218|||||||Chi-squared, Corrected|||Parameter: The incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0218
71709160|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0297|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.0297
71709161|NCT02732145|142935198|SUPERIORITY|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.||||0.6468
71709162|NCT02732145|142935199|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.2045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.2045
71709163|NCT02732145|142935199|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.7469|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.7469
71709164|NCT02732145|142935199|SUPERIORITY|Question: Is there a difference in the incidence of the finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.4271|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.4271
71765358|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.5988|TWO_SIDED|95.0|-2.6|1.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical (norm-based).||1.5|-2.6|0.5988
71826679|NCT00383188|143158057|SUPERIORITY||LSM Difference|-0.251|STANDARD_ERROR_OF_MEAN|1.048||0.8107|TWO_SIDED|95.0|-2.307|1.805|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.805|-2.307|0.8107
71765359|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|0.1||||0.9642|TWO_SIDED|95.0|-2.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index (norm-based).||2.6|-2.5|0.9642
71765360|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|1.5||||0.1542|TWO_SIDED|95.0|-0.6|3.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions (norm-based).||3.5|-0.6|0.1542
71655383|NCT03456960|142829236|EQUIVALENCE|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0148|||||TWO_SIDED|90.0|-0.0734|0.103||||||||0.1030|-0.0734|
71655384|NCT03456960|142829236|EQUIVALENCE|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.002|||||TWO_SIDED|90.0|-0.0463|0.0424||||||||0.0424|-0.0463|
71655385|NCT03456960|142829237|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2138|||||TWO_SIDED|90.0|0.1609|0.2667||||||||0.2667|0.1609|
71655386|NCT03456960|142829238|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2161|||||TWO_SIDED|90.0|0.1652|0.2671||||||||0.2671|0.1652|
71655387|NCT03456960|142829239|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.219|||||TWO_SIDED|90.0|0.1675|0.2706||||||||0.2706|0.1675|
71655388|NCT03456960|142829240|EQUIVALENCE|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.3653|||||TWO_SIDED|90.0|0.218|0.5126||||||||0.5126|0.2180|
71655389|NCT03456960|142829243|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2089|||||TWO_SIDED|90.0|-0.0061|0.4239||||||||0.4239|-0.0061|
71655390|NCT03456960|142829243|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.014|||||TWO_SIDED|90.0|-0.0639|0.0918||||||||0.0918|-0.0639|
71655391|NCT03456960|142829244|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2099|||||TWO_SIDED|90.0|-0.0048|0.4246||||||||0.4246|-0.0048|
71655392|NCT03456960|142829244|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0137|||||TWO_SIDED|90.0|-0.0712|0.0986||||||||0.0986|-0.0712|
71655393|NCT03456960|142829245|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2096|||||TWO_SIDED|90.0|-0.0054|0.4246||||||||0.4246|-0.0054|
71655394|NCT03456960|142829245|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0201|||||TWO_SIDED|90.0|-0.069|0.1092||||||||0.1092|-0.0690|
71709165|NCT02732145|142935199|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.3607|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.3607
71709166|NCT02732145|142935199|SUPERIORITY|Question: Is there a difference in the incidence of the finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.||||0.8672
71709167|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0045
71709168|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0032
71709169|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.1067|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.1067
71709170|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of inflammatory cells in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8672
71709171|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0219|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0219
71709172|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8213|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.8213
71709173|NCT02732145|142935200|SUPERIORITY|Question: Is there a difference in the incidence of the finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0613|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.||||0.0613
71709174|NCT01837550|142935203|NON_INFERIORITY_OR_EQUIVALENCE|To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen's d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power.||||||0.685|||||||Mixed Models Analysis|||||||0.685
71709175|NCT04191733|142935213|NON_INFERIORITY|The non-inferiority analysis was demonstrated when the 1-sided upper 95% confidence interval (CI) limit was less than 1.25.|||||<|0.0001||||||one-sided p-value|t-test, 1 sided|||||||<0.0001
71709176|NCT04191733|142935214|NON_INFERIORITY|1-sided test with 5% alpha was used to demonstrate non-inferiority with greater than 99% power. The non-inferiority margin was 3.75 minutes.||||||0.1004|||||||t-test, 1 sided|||A gatekeeping strategy was used to control family-wise type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The testing sequence continued only when previous endpoint was statistically significant with a 1-sided alpha of 0.05.||||0.1004
71709177|NCT00928720|142935233|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
71709178|NCT02349477|142935239|SUPERIORITY||Odds Ratio (OR)|3.9||||0.028|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.||||.028
71765361|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|0.6||||0.602|TWO_SIDED|95.0|-1.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality (norm-based).||2.6|-1.5|0.6020
71765362|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-0.6||||0.634|TWO_SIDED|95.0|-3.1|1.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning (norm-based).||1.9|-3.1|0.6340
71765363|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.3384|TWO_SIDED|95.0|-4.1|1.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional (norm-based).||1.4|-4.1|0.3384
71709179|NCT02349477|142935240|SUPERIORITY||Odds Ratio (OR)|4.9||||0.053|TWO_SIDED||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.||||.053
71709180|NCT02349477|142935241|SUPERIORITY|||||||0.001|||||||Chi-squared|||For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.001
71709181|NCT02349477|142935241|SUPERIORITY|||||||0.67|||||||Chi-squared|||For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.||||.67
71709182|NCT01714063|142935242|OTHER|We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter|||||<|0.001|||||||paired t-test|||||||<0.001
71709183|NCT02633527|142935250|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.0899|TWO_SIDED|95.0|-13.4|1.0|||ANOVA|||||1.0|-13.4|0.0899
71709184|NCT02633527|142935250|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.031|TWO_SIDED|95.0|-15.1|-0.7|||ANOVA|||||-0.7|-15.1|0.0310
71709185|NCT02633527|142935250|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.0268|TWO_SIDED|95.0|-15.3|-0.9|||ANOVA|||||-0.9|-15.3|0.0268
71709186|NCT02633527|142935250|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0209|TWO_SIDED|95.0|-15.8|-1.3|||ANOVA|||||-1.3|-15.8|0.0209
71709187|NCT02633527|142935251|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1305|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1305
71709188|NCT02633527|142935251|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.1376|TWO_SIDED|95.0|-1.0|0.1|||ANOVA|||||0.1|-1.0|0.1376
71709189|NCT02633527|142935251|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.009|TWO_SIDED|95.0|-1.3|-0.2|||ANOVA|||||-0.2|-1.3|0.0090
71709190|NCT02633527|142935251|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0546|TWO_SIDED|95.0|-1.1|0.0|||ANOVA|||||0.0|-1.1|0.0546
71709191|NCT02633527|142935252|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0708|TWO_SIDED|95.0|-1.3|0.1|||ANCOVA|||||0.1|-1.3|0.0708
71709192|NCT02633527|142935252|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0309|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|||||-0.1|-1.4|0.0309
71765364|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-1.3||||0.2704|TWO_SIDED|95.0|-3.6|1.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.||1.0|-3.6|0.2704
71765365|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|0.7||||0.4332|TWO_SIDED|95.0|-1.0|2.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Physical Component Summary Score.||2.3|-1.0|0.4332
71765366|NCT01743001|143033068|SUPERIORITY||least-square (LS) mean difference|-1.1||||0.3416|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Mental Component Summary Score.||1.2|-3.4|0.3416
71765367|NCT01565343|143033069|SUPERIORITY_OR_OTHER||ICC|0.9893||||||95.0|||||ICC|||Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest values||||
71765368|NCT01565343|143033069|SUPERIORITY_OR_OTHER||ICC|0.9574||||||95.0|||||ICC|||Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest values||||
71765369|NCT01565343|143033069|SUPERIORITY_OR_OTHER||Mean % difference|2.35|STANDARD_DEVIATION|1.413||||95.0||||||||Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values||||
71765370|NCT01565343|143033069|SUPERIORITY_OR_OTHER||Mean % difference|1.49|STANDARD_DEVIATION|0.839||||95.0||||||||Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values||||
71765371|NCT00835211|143033100|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|97.5||||||90.0|87.8|108.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108.3|87.8|
71709193|NCT02633527|142935252|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0148|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA|||||-0.2|-1.5|0.0148
71709194|NCT02633527|142935252|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0136|TWO_SIDED|95.0|-1.6|-0.2|||ANCOVA|||||-0.2|-1.6|0.0136
71709195|NCT04135443|142935259|SUPERIORITY||Odds Ratio (OR)|1.027||||0.94|TWO_SIDED|95.0|0.511|2.063|||Regression, Logistic|||||2.063|0.511|0.94
71709196|NCT04135443|142935261|SUPERIORITY||Slope|0.064||||0.455|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.455
71709197|NCT04135443|142935262|SUPERIORITY||Slope|0.026||||0.702|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.702
71709198|NCT04135443|142935263|SUPERIORITY||Slope|0.049||||0.375|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.375
71709199|NCT04135443|142935264|SUPERIORITY||Slope|0.076||||0.313|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.313
71709200|NCT04135443|142935265|SUPERIORITY||Slope|-0.01||||0.89|TWO_SIDED|||||Threshold set to p\<0.05.|Regression, Linear|See analysis plan for covariates screened into model.||||||0.890
71709201|NCT03856177|142935276|OTHER|||||||0.071|||||||t-test, 2 sided|||||||.071
71709202|NCT03460704|142935279|SUPERIORITY||LS Mean rate ratio|1.004||||0.97889|TWO_SIDED|95.0|0.747|1.349|||negative binomial model|||The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, country, and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-exposure time on treatment as an offset.||1.349|0.747|0.97889
71709203|NCT01767857|142935297|SUPERIORITY|||||||0.613|||||||Log Rank|||||||0.613
71765372|NCT00835211|143033101|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|95.6||||||90.0|86.9|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.2|86.9|
71709204|NCT01767857|142935298|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
71709205|NCT01767857|142935299|SUPERIORITY|||||||0.541|||||||ANCOVA|||Statistical Analysis for Global Health Status/Qol||||0.541
71709206|NCT01767857|142935299|SUPERIORITY|||||||0.56|||||||ANCOVA|||Statistical Analysis for Pain||||0.560
71709207|NCT01767857|142935299|SUPERIORITY|||||||0.603|||||||ANCOVA|||Statistical Analysis for Fatigue||||0.603
71709208|NCT01767857|142935299|SUPERIORITY|||||||0.485|||||||ANCOVA|||Statistical Analysis for Appetite Loss||||0.485
71709209|NCT01767857|142935300|SUPERIORITY|||||||0.21|||||||ANCOVA|||||||0.210
71709210|NCT01767857|142935301|SUPERIORITY|||||||0.768|||||||Log Rank|||||||0.768
71709211|NCT03657407|142935335|SUPERIORITY||Mean Difference (Final Values)|-0.65||||0.17|TWO_SIDED|95.0|-0.71|2.0|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||2.0|-0.71|0.17
71709212|NCT03657407|142935336|SUPERIORITY||Mean Difference (Final Values)|-2.02||||0.29|TWO_SIDED|95.0|-5.4|9.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||9.5|-5.4|0.29
71709213|NCT03657407|142935337|SUPERIORITY||Median Difference (Final Values)|-19.31||||0.05|TWO_SIDED|95.0|-43.1|4.5|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||4.5|-43.1|0.05
71709214|NCT03657407|142935338|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.42|TWO_SIDED|95.0|0.42|1.7|||t-test, 1 sided|||Null hypothesis that Belladonna \& Opium not superior to Placebo||1.7|0.42|0.42
71709215|NCT02628145|142935339|OTHER||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
71709216|NCT02628145|142935340|SUPERIORITY|||||||0.88|||||||Chi-squared|||||||0.88
71709217|NCT02628145|142935341|SUPERIORITY|||||||0.068|||||||Fisher Exact|||||||0.068
71709218|NCT02628145|142935342|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
71709219|NCT02628145|142935343|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
71709220|NCT02628145|142935344|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71765373|NCT00835211|143033102|NON_INFERIORITY_OR_EQUIVALENCE|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|96.5||||||90.0|87.7|106.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.1|87.7|
71709221|NCT02628145|142935345|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71709222|NCT02628145|142935346|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71709223|NCT02628145|142935347|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71709224|NCT02628145|142935349|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71709225|NCT00420056|142935352|SUPERIORITY_OR_OTHER|||||||0.4854|TWO_SIDED||||||Regression, Linear|||||||0.4854
71709226|NCT00420056|142935353|SUPERIORITY_OR_OTHER|||||||0.709|TWO_SIDED||||||Regression, Linear|||||||0.7090
71709227|NCT00420056|142935356|SUPERIORITY_OR_OTHER||Kappa|0.0638|||||TWO_SIDED|95.0|-0.0449|0.1726||||||FLT-PET response versus Objective response||0.1726|-0.0449|
71709228|NCT00420056|142935356|SUPERIORITY_OR_OTHER||Kappa|0.1864|||||TWO_SIDED|95.0|-0.2316|0.6045||||||FDG-PET response versus Objective response||0.6045|-0.2316|
71709229|NCT00420056|142935370|SUPERIORITY_OR_OTHER|||||||0.5954|TWO_SIDED||||||Regression, Linear|||Concentration versus Ki-67||||0.5954
71709230|NCT00420056|142935370|SUPERIORITY_OR_OTHER|||||||0.1286|TWO_SIDED||||||Regression, Linear|||Concentration versus Cyclin D1||||0.1286
71709231|NCT00420056|142935370|SUPERIORITY_OR_OTHER|||||||0.0956|TWO_SIDED||||||Regression, Linear|||Concentration versus phospho-Rb||||0.0956
71709232|NCT00420056|142935370|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Linear|||Concentration versus FLT-PET SUVmax||||0.2800
71709233|NCT00420056|142935370|SUPERIORITY_OR_OTHER|||||||0.4921|TWO_SIDED||||||Regression, Linear|||Concentration versus FDG-PET SUVmax||||0.4921
71709234|NCT00907088|142935379|SUPERIORITY_OR_OTHER|||||||0.42|||||||Chi-squared|||||||0.42
71709235|NCT02301793|142935382|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
71709236|NCT02301793|142935386|OTHER||Odds Ratio (OR)|1.0||||0.05|TWO_SIDED|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.||||0.05
71709237|NCT04105725|142935389|SUPERIORITY||||||<|0.05|||||||negative binomial regression|||||||<0.05
71709238|NCT02457546|142935404|NON_INFERIORITY|"The statistical hypothesis for testing the treatment difference was presented as follows:~H0: Δ ≤ -0.10 tested against the alternative hypothesis Ha: Δ \> -0.10. where:~* Δ is the difference between the success rates of Experimental (Evicel®) and Control (DuraSeal™) (Experimental minus Control)~* -0.10 is the non-inferiority difference PC is the proportion of success in DuraSeal™ Control subjects and PE is the proportion of success in EVICEL® subjects."|Difference in Success Rates|6.3|||||TWO_SIDED|95.0|-1.8|14.4||||||||14.4|-1.8|
71655395|NCT03456960|142829246|EQUIVALENCE|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.4058|||||TWO_SIDED|90.0|0.0803|0.7312||||||||0.7312|0.0803|
71709239|NCT01500135|142935466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|STANDARD_ERROR_OF_MEAN|0.72||0.276|TWO_SIDED|95.0|0.68|3.88||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||3.88|0.68|0.276
71709240|NCT01500135|142935467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.33||0.684|TWO_SIDED|95.0|0.4|1.82||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic|||||1.82|0.40|0.684
71709241|NCT01500135|142935468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.684|TWO_SIDED|95.0|0.7|1.8||P-value was adjusted using Hochberg's adjustment for multiplicity.|Proportional Hazard Model|||||1.8|0.7|0.684
71709242|NCT03523585|142935492|SUPERIORITY||Hazard Ratio (HR)|0.3589|||<|1e-06|TWO_SIDED|95.0|0.284|0.4535||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.4535|0.2840|<0.000001
71709243|NCT03523585|142935493|SUPERIORITY||Hazard Ratio (HR)|0.6575||||0.0021|TWO_SIDED|95.0|0.5023|0.8605||Stratified Log-rank p-value|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.8605|0.5023|0.0021
71709244|NCT03523585|142935494|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for BICR Assessment||||<0.0001
71709245|NCT03523585|142935494|SUPERIORITY||||||<|0.0001||||||Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|Cochran-Mantel-Haenszel|||Statistical Analysis for Investigator Assessment||||<0.0001
71709246|NCT03523585|142935496|SUPERIORITY||Hazard Ratio (HR)|0.2828|||<|1e-06|TWO_SIDED|95.0|0.227|0.3524||Stratified Log-rank p-value.|Log Rank|p value based on log-rank stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by IXRS|Hazard Ratio based on stratified Cox proportional hazards model with stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.|||0.3524|0.2270|<0.000001
71709247|NCT00830336|142935625|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|103.08||||||90.0|95.41|111.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111.37|95.41|
71709248|NCT00830336|142935626|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|105.84||||||90.0|99.33|112.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112.77|99.33|
71709249|NCT00830336|142935627|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|107.04||||||90.0|99.96|114.62|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114.62|99.96|
71709250|NCT04526158|142935695|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.031|TWO_SIDED|95.0|0.0|0.6||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|0.0|0.031
71709251|NCT04526158|142935695|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED|95.0|-0.7|-0.2||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|0.002
71709252|NCT04526158|142935695|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||significance threshold = 0.0167 due to multiple comparisons|Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-1.0|<0.001
71709253|NCT04526158|142935696|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.736|TWO_SIDED|95.0|-0.2|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.2|0.736
71709254|NCT04526158|142935696|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.6|<0.001
71709255|NCT04526158|142935696|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of BPI intensity, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-0.7|<0.001
71765374|NCT05498701|143033110|OTHER||Ratios of Adjusted Geometric Means|93.19|||||TWO_SIDED|90.0|87.1|99.7||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis AUCinf fell entirely within the acceptance region of (80%,125%).||99.70|87.10|
71765375|NCT05498701|143033111|OTHER||Ratio of Adjusted Geometric Means|81.0||||||90.0|76.25|86.04||||||Bioequivalence of the Test treatment (Tafamidis free acid 12.2 mg oral tablet \[Fasted\]) to Reference treatment (Tafamidis meglumine 20 mg oral capsule \[Fasted\]) was concluded if the 90% confidence intervals for the ratios of adjusted geometric means for tafamidis Cmax fell entirely within the acceptance region of (80%,125%).||86.04|76.25|
71826680|NCT00383188|143158057|SUPERIORITY||LSM Difference|0.272|STANDARD_ERROR_OF_MEAN|1.017||0.7895|TWO_SIDED|95.0|-1.726|2.269|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.269|-1.726|0.7895
71826681|NCT00383188|143158057|SUPERIORITY||LSM Difference|-0.306|STANDARD_ERROR_OF_MEAN|1.206||0.7996|TWO_SIDED|95.0|-2.673|2.06|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.060|-2.673|0.7996
71826682|NCT00383188|143158057|SUPERIORITY||LSM Difference|0.185|STANDARD_ERROR_OF_MEAN|1.235||0.8811|TWO_SIDED|95.0|-2.24|2.61|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||2.610|-2.240|0.8811
71709256|NCT04526158|142935697|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.829|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.4|0.829
71709257|NCT04526158|142935697|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.005|TWO_SIDED|95.0|0.2|0.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.9|0.2|0.005
71709258|NCT04526158|142935697|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.004|TWO_SIDED|95.0|0.2|1.0|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Physical function, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.0|0.2|0.004
71709259|NCT04526158|142935698|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.079|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.8|0.0|0.079
71709260|NCT04526158|142935698|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.296|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.2|-0.6|0.296
71709261|NCT04526158|142935698|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS Anxiety, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.0|0.005
71709262|NCT04526158|142935699|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.464|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.7|-0.3|0.464
71709263|NCT04526158|142935699|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.019|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.1|-1.1|0.019
71709264|NCT04526158|142935699|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.002|TWO_SIDED|95.0|-1.3|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS fatigue, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.3|0.002
71709265|NCT04526158|142935700|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.5|0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.4|-0.5|0.889
71765376|NCT00600119|143033133|SUPERIORITY_OR_OTHER|||||||0.7781|||||||Wilcoxon (Mann-Whitney)|||||||0.7781
71765377|NCT00600119|143033133|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.0020
71765378|NCT00600119|143033133|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71765379|NCT00600119|143033134|SUPERIORITY_OR_OTHER|||||||0.5118|||||||Wilcoxon (Mann-Whitney)|||||||0.5118
71826683|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.687|STANDARD_ERROR_OF_MEAN|0.886||0.4385|TWO_SIDED|95.0|-2.427|1.053|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.053|-2.427|0.4385
71709266|NCT04526158|142935700|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.004|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.004
71709267|NCT04526158|142935700|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.006|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS sleep disturbance, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.1|0.006
71709268|NCT04526158|142935701|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.76|TWO_SIDED|95.0|-0.4|0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.5|-0.4|0.76
71709269|NCT04526158|142935701|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.4|0.6|<0.001
71765380|NCT00600119|143033134|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||||||0.0022
71765381|NCT00600119|143033134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71765382|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.5522||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5522
71826684|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.085|STANDARD_ERROR_OF_MEAN|0.87||0.2131|TWO_SIDED|95.0|-2.794|0.624|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.624|-2.794|0.2131
71655396|NCT03456960|142829246|EQUIVALENCE|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed \[30 minutes after starting breakfast\] - TAK-438ASA tablet taken in a fasted \[without breakfast\] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.1969|||||TWO_SIDED|90.0|0.1065|0.2873||||||||0.2873|0.1065|
71655397|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-3.0|5.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-3.0|
71655398|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|2.66|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-1.4|6.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.8|-1.4|
71655399|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-1.1|7.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.1|-1.1|
71655400|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|2.53|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-1.6|6.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.6|
71655401|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.0789|||TWO_SIDED|95.0|-2.4|5.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.8|-2.4|
71709270|NCT04526158|142935701|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.5|1.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PROMIS social roles and activities, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.3|0.5|<0.001
71709271|NCT04526158|142935702|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.6|-0.7|0.89
71709272|NCT04526158|142935702|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.3|-1.5|0.003
71709273|NCT04526158|142935702|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.007|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PHQ8, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.2|-1.5|0.007
71709274|NCT04526158|142935703|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.886|TWO_SIDED|95.0|-1.6|1.9|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||1.9|-1.6|0.886
71709275|NCT04526158|142935703|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.017|TWO_SIDED|95.0|-3.7|-0.4|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.4|-3.7|0.017
71709276|NCT04526158|142935703|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.013|TWO_SIDED|95.0|-3.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline values of PCL5, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-3.9|0.013
71709277|NCT04526158|142935704|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.437|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||0.3|-0.1|0.437
71709278|NCT04526158|142935704|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.5|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.5|-0.9|<0.001
71709279|NCT04526158|142935704|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|Linear mixed model adjusted for baseline Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-0.6|-1.0|<0.001
71765383|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.0589||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0589
71765384|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.1691||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1691
71655402|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.079|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
71655403|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.0792|||TWO_SIDED|95.0|-7.2|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-7.2|
71655404|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.0796|||TWO_SIDED|95.0|-5.4|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-5.4|
71655405|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.15|STANDARD_ERROR_OF_MEAN|2.0801|||TWO_SIDED|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-4.2|
71655406|NCT02037165|142829266|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.68|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-6.7|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-6.7|
71655407|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|1.58|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-2.4|5.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.6|-2.4|
71655408|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-1.4|6.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.6|-1.4|
71709280|NCT04526158|142935705|SUPERIORITY||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-13.9|-1.2||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||-1.2|-13.9|
71765385|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.6293||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6293
71765386|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.0836||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0836
71765387|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.1155||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1155
71826685|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.013||0.1216|TWO_SIDED|95.0|-3.559|0.419|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||0.419|-3.559|0.1216
71826686|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.675|STANDARD_ERROR_OF_MEAN|1.046||0.519|TWO_SIDED|95.0|-2.728|1.378|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline tender/ joint count as the covariate and participant as a random effect.||1.378|-2.728|0.5190
71826687|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.464|STANDARD_ERROR_OF_MEAN|0.88||0.0967|TWO_SIDED|95.0|-3.193|0.264|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.264|-3.193|0.0967
71709281|NCT04526158|142935705|SUPERIORITY||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|6.4|17.6||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||17.6|6.4|
71709282|NCT04526158|142935705|SUPERIORITY||Mean Difference (Final Values)|19.5|||||TWO_SIDED|95.0|13.6|25.4||Used confidence interval to determine significance.|Mixed Models Analysis|Logistic mixed model adjusted for baseline values of BPI interference, Pain Self-Efficacy, and design factors|estimates were generated from multiple imputed data|||25.4|13.6|
71709283|NCT03533491|142935720|EQUIVALENCE|A test of the null hypothesis that the proportion of participants from pretest to posttest change is equal to zero.|Proportion Difference|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.044|TWO_SIDED||||||t-test, 2 sided||A paired t-test that evaluates whether significant pretest to posttest change in the proportion of users is different from zero.|||||.044
71709284|NCT03533491|142935721|EQUIVALENCE|A test of the null hypothesis that the proportion who use from pretest to posttest is equal to zero.|Proportion Difference|0.035|STANDARD_ERROR_OF_MEAN|0.056||0.532|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether the proportion who use from pretest to posttest change is different from zero.||||||.532
71709285|NCT03533491|142935722|EQUIVALENCE|A test of the null hypothesis that the proportion of participants who use from pretest to posttest is equal to zero.|Proportion Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.058||0.37|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.370
71709286|NCT03533491|142935723|EQUIVALENCE|A test of the null hypothesis that the proportion of participants that use from pretest to posttest is equal to zero.|Proportion Difference|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether proportion who use from pretest to posttest is different from zero.||||||.020
71709287|NCT03533491|142935724|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.108||0.773|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.773
71709288|NCT03533491|142935725|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.08||0.978|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.978
71709289|NCT03533491|142935726|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.089||0.745|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.745
71709290|NCT03533491|142935727|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.154|STANDARD_ERROR_OF_MEAN|0.101||0.132|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.132
71826688|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.027|STANDARD_ERROR_OF_MEAN|0.863||0.2346|TWO_SIDED|95.0|-2.721|0.668|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.668|-2.721|0.2346
71826689|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.658|STANDARD_ERROR_OF_MEAN|1.007||0.1|TWO_SIDED|95.0|-3.635|0.318|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.318|-3.635|0.1000
71826690|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.805|STANDARD_ERROR_OF_MEAN|1.038||0.4385|TWO_SIDED|95.0|-2.844|1.234|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.234|-2.844|0.4385
71709291|NCT03533491|142935728|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.551|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.551
71709292|NCT03533491|142935729|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.255||0.255|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.255
71709293|NCT03533491|142935730|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|||||||A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||
71709294|NCT03533491|142935731|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.091||0.198|TWO_SIDED||||||t-test, 2 sided|||||||.198
71826691|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.599|STANDARD_ERROR_OF_MEAN|0.88||0.0696|TWO_SIDED|95.0|-3.327|0.128|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.128|-3.327|0.0696
71826692|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.863||0.0642|TWO_SIDED|95.0|-3.294|0.094|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.094|-3.294|0.0642
71709295|NCT03533491|142935732|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.121||0.77|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.770
71709296|NCT03533491|142935733|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.137||0.834|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.834
71709297|NCT03533491|142935734|EQUIVALENCE|A test of the null hypothesis that the pretest to posttest change is equal to zero.|Mean Difference (Final Values)|-0.096|STANDARD_ERROR_OF_MEAN|0.07||0.175|TWO_SIDED||||||t-test, 2 sided|A paired t-test that evaluates whether significant pretest to posttest change is different from zero.||||||.175
71709298|NCT01725282|142935739|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-3.1|3.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||3.6|-3.1|
71709299|NCT01725282|142935739|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-4.0|2.8|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||2.8|-4.0|
71709300|NCT01725282|142935739|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-2.1|4.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.|||4.6|-2.1|
71709301|NCT05263791|142935748|NON_INFERIORITY|The primary objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR.|||||<|0.001|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -3, In the target of p\<0.05 indicates significance.||||<0.001
71709302|NCT05263791|142935749|NON_INFERIORITY|The hypothesis tested is demonstrated airRR non-inferior to acoRR when the capnostream is less sensitive.|||||<|0.001|||||||Paired t Test|||"In this study, a non-inferiority test was conducted during periods of reduced sensitivity in capnography to compare respiratory rate measurements using the Airmod device (airRR) versus manually scored auscultation sounds (referred to as acoRR, implying manARR in the statistical analysis plan). The research physician identified periods of reduced sensitivity in capnography."||||<0.001
71709303|NCT05263791|142935751|SUPERIORITY|This analysis were examined to assess the responsiveness of Airmod and Capnography.|||||<|0.001|||||||Paired t Test|||The hypothesis tested whether the response times obtained with the Airmod device were equal to those recorded with Capnography.||||<0.001
71709304|NCT05263791|142935752|NON_INFERIORITY|The objective to prove the non-inferiority in between the Airmod and reference device is determined by the difference between AirRR and ManCRR by subjects.|||||<|0.05|||||||Paired t Test|||Hypothesis: airRR-mancRR ≦ -2, In the target of p\<0.05 indicates significance.||||<0.05
71709305|NCT04576481|142935756|SUPERIORITY||F-Statistic|1.18||||0.32|TWO_SIDED||||||ANOVA|||Analysis of Variance statistical testing.||||0.32
71709306|NCT04576481|142935757|SUPERIORITY||F-Statistic|0.25||||0.78|TWO_SIDED||||||ANOVA|||||||0.78
71765388|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.9938||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9938
71826693|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.83|STANDARD_ERROR_OF_MEAN|1.007||0.0695|TWO_SIDED|95.0|-3.807|0.146|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.146|-3.807|0.0695
71886674|NCT02475655|143293590|SUPERIORITY||Mean Difference (Net)|-0.39||||0.74|TWO_SIDED|90.0|-2.41|1.62||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 12.||1.62|-2.41|0.74
71709307|NCT04576481|142935758|SUPERIORITY|||||||0.19|||||||ANOVA|||||||0.19
71709308|NCT04576481|142935759|SUPERIORITY|||||||0.46|||||||ANOVA|||||||0.46
71709309|NCT04576481|142935760|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
71709310|NCT01946880|142935761|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.068|0.214||||||||0.214|-0.068|
71709311|NCT01946880|142935763|OTHER||Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.116|0.279||||||||0.279|-0.116|
71709312|NCT01946880|142935764|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.091|0.36||||||||0.360|-0.091|
71709313|NCT01946880|142935765|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.07|||||TWO_SIDED|95.0|-0.475|0.333||||||||0.333|-0.475|
71709314|NCT01946880|142935766|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.286|0.249||||||The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.||0.249|-0.286|
71709315|NCT01946880|142935767|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.09|0.497||||||||0.497|-0.090|
71709316|NCT01946880|142935768|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.08|||||TWO_SIDED|95.0|-0.056|0.211||||||||0.211|-0.056|
71709317|NCT01946880|142935769|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.12|||||TWO_SIDED|95.0|-0.041|0.284||||||||0.284|-0.041|
71709318|NCT01946880|142935770|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|-0.04|||||TWO_SIDED|95.0|-0.285|0.206||||||||0.206|-0.285|
71709319|NCT01946880|142935771|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.118|0.289||||||||0.289|-0.118|
71709320|NCT01946880|142935772|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.05|||||TWO_SIDED|95.0|-0.103|0.212||||||||0.212|-0.103|
71709321|NCT01946880|142935775|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.028|0.149||||||||0.149|-0.028|
71709322|NCT01946880|142935776|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.06|||||TWO_SIDED|95.0|-0.02|0.134||||||||0.134|-0.020|
71826694|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.493|STANDARD_ERROR_OF_MEAN|1.038||0.6349|TWO_SIDED|95.0|-2.532|1.545|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.545|-2.532|0.6349
71826695|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.176|STANDARD_ERROR_OF_MEAN|0.88||0.1818|TWO_SIDED|95.0|-2.903|0.551|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.551|-2.903|0.1818
71709323|NCT01946880|142935777|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 24.||0.1|-0.1|
71709324|NCT01946880|142935777|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 48.||0.1|-0.1|
71709325|NCT01946880|142935777|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 60.||0.1|-0.2|
71709326|NCT01946880|142935778|OTHER|The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.019|0.059||||||||0.059|-0.019|
71709327|NCT01946880|142935780|OTHER||Mean Difference (Final Values)|1.61|||||TWO_SIDED|95.0|-2.24|5.45|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 24.||5.45|-2.24|
71709328|NCT01946880|142935780|OTHER||Mean Difference (Final Values)|2.54|||||TWO_SIDED|95.0|-1.13|6.21|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 48.||6.21|-1.13|
71886675|NCT02475655|143293591|SUPERIORITY||Mean Difference (Net)|0.55||||0.71|TWO_SIDED|90.0|-1.9|3.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 5.||3.00|-1.90|0.71
71709329|NCT01946880|142935780|OTHER||Mean Difference (Final Values)|3.55|||||TWO_SIDED|95.0|-0.17|7.28|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 60.||7.28|-0.17|
71765389|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.2101||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.2101
71826696|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.268|STANDARD_ERROR_OF_MEAN|0.862||0.1421|TWO_SIDED|95.0|-2.961|0.426|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.426|-2.961|0.1421
71709330|NCT01946880|142935781|OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.82|2.92|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 24.||2.92|-1.82|
71826697|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.898|STANDARD_ERROR_OF_MEAN|1.006||0.3726|TWO_SIDED|95.0|-2.874|1.078|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.078|-2.874|0.3726
71655409|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.2|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-4.2|
71655410|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.0276|||TWO_SIDED|95.0|-2.8|5.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.2|-2.8|
71655411|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|2.0277|||TWO_SIDED|95.0|-4.6|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-4.6|
71655412|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.88|STANDARD_ERROR_OF_MEAN|2.0278|||TWO_SIDED|95.0|-6.9|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-6.9|
71655413|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|2.0279|||TWO_SIDED|95.0|-3.6|4.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-3.6|
71655414|NCT02037165|142829266|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|2.0282|||TWO_SIDED|95.0|-5.0|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-5.0|
71655415|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.6|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-4.6|
71655416|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.87|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-6.5|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-6.5|
71709331|NCT01946880|142935781|OTHER||Mean Difference (Final Values)|1.44|||||TWO_SIDED|95.0|-1.14|4.03|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 48.||4.03|-1.14|
71709332|NCT01946880|142935781|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|95.0|-0.71|4.67|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 60.||4.67|-0.71|
71709333|NCT01946880|142935782|OTHER||Mean Difference (Final Values)|1.65|||||TWO_SIDED|95.0|-1.03|4.32|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 24.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 24.||4.32|-1.03|
71709334|NCT01946880|142935782|OTHER||Mean Difference (Final Values)|2.17|||||TWO_SIDED|95.0|-0.69|5.02|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 48.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 48.||5.02|-0.69|
71709335|NCT01946880|142935782|OTHER||Mean Difference (Final Values)|3.02|||||TWO_SIDED|95.0|0.22|5.82|||||Estimate is for the difference in the change from baseline for MMF Withdrawal - MMF Maintenance at Week 60.|Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 60.||5.82|0.22|
71765390|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.4597||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4597
71765391|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.4822||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.4822
71826698|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.701|STANDARD_ERROR_OF_MEAN|1.038||0.4995|TWO_SIDED|95.0|-2.739|1.337|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.337|-2.739|0.4995
71826699|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.601|STANDARD_ERROR_OF_MEAN|0.879||0.0691|TWO_SIDED|95.0|-3.327|0.126|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.126|-3.327|0.0691
71826700|NCT00383188|143158058|SUPERIORITY||LSM Difference|-1.086|STANDARD_ERROR_OF_MEAN|0.862||0.2083|TWO_SIDED|95.0|-2.778|0.607|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||0.607|-2.778|0.2083
71709336|NCT04543786|142935805|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 2.|Mean Difference (Final Values)|2.8||||0.0048|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|One-way||||||0.0048
71709337|NCT04543786|142935806|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 3.|Mean Difference (Final Values)|3.72|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||< 0.001
71709338|NCT04543786|142935807|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 4.|Mean Difference (Final Values)|3.24|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
71709339|NCT04543786|142935808|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|20.84|||<|0.001|TWO_SIDED|||||Bonferroni post-hoc tests; p \< 0.05 was considered significant|ANOVA|||||||<0.001
71709340|NCT04543786|142935810|OTHER|No comparison was made to another intervention or therapy. Comparing values at baseline and Day 5.|Mean Difference (Final Values)|26.78|||<|0.001|TWO_SIDED|||||p \< 0.05 was considered significant|t-test, 2 sided|paired||||||<0.001
71765392|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.0171||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0171
71765393|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.016||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0160
71709341|NCT04543786|142935811|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71709342|NCT04543786|142935812|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|2.3||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71709343|NCT04543786|142935813|OTHER|No comparison was made to another intervention or therapy|Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71765394|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.6857||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.6857
71765395|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.0253||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0253
71765396|NCT00600119|143033135|SUPERIORITY_OR_OTHER|||||||0.0772||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0772
71826701|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.836|STANDARD_ERROR_OF_MEAN|1.006||0.4063|TWO_SIDED|95.0|-2.811|1.139|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.139|-2.811|0.4063
71886676|NCT02475655|143293591|SUPERIORITY||Mean Difference (Net)|0.31||||0.83|TWO_SIDED|90.0|-2.15|2.78||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 12.||2.78|-2.15|0.83
71709344|NCT04543786|142935814|OTHER|No comparison was made to another intervention or therapy.|Mean Difference (Final Values)|1.5||||0.56|TWO_SIDED|||||p \< 0.05 was considered significant|ANOVA|Repeated measures||||||0.56
71709345|NCT04204902|142935819|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|91.15|||||TWO_SIDED|90.0|83.21|99.84||||||||99.84|83.21|
71709346|NCT04204902|142935820|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least square Mean|90.92|||||TWO_SIDED|90.0|82.99|99.61||||||||99.61|82.99|
71709347|NCT04204902|142935821|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90 percentage Confidence Interval (CI) as 80.00 percentage - 125.00 percentage|Ratio of Geometric Least Square Mean|104.62|||||TWO_SIDED|90.0|95.17|115.0||||||||115.00|95.17|
71709348|NCT00489476|142935913|SUPERIORITY|||||||0.0212|||||||Fisher Exact|||||||0.0212
71709349|NCT00489476|142935913|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
71709350|NCT00489476|142935914|SUPERIORITY|||||||0.0123|||||||Fisher Exact|||||||0.0123
71709351|NCT00489476|142935914|SUPERIORITY|||||||0.0228|||||||Fisher Exact|||||||0.0228
71709352|NCT00489476|142935915|SUPERIORITY|||||||0.0409|||||||Fisher Exact|||||||0.0409
71765397|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.5008||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5008
71709353|NCT00480025|142935916|SUPERIORITY|RMF included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \>100 cigarettes and past smoker).|Treatment Efficacy|1.024||||0.7379|TWO_SIDED|95.0|0.891|1.177||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|Overall population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.||1.177|0.891|0.7379
71709354|NCT00480025|142935917|SUPERIORITY|RMF taken into account included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. \> 100 cigarettes and current smoker vs. \> 100 cigarettes and past smoker).|Treatment Efficacy|0.97||||0.7572|TWO_SIDED|95.0|0.797|1.179||2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.|Regression, Cox|No-CT population objective reached if p-value \< 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.||Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.||1.179|0.797|0.7572
71709355|NCT03726879|142935953|SUPERIORITY||Odds Ratio (OR)|0.67||||0.1846|TWO_SIDED|95.0|0.37|1.21||The threshold for statistical significance was a p-value =0.048|Cochran-Mantel-Haenszel|||||1.21|0.37|0.1846
71709356|NCT03726879|142935954|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9551|TWO_SIDED|95.0|0.67|1.46||The threshold for statistical significance was a p-value =0.002|Cochran-Mantel-Haenszel|||||1.46|0.67|0.9551
71709357|NCT03726879|142935957|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.59|||Log Rank|||All Participants||1.59|0.50|
71765398|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.1823||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1823
71765399|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.7045||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7045
71765400|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.7088||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7088
71765401|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.5828||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.5828
71765402|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.0116||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0116
71709358|NCT03726879|142935957|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.65|4.32|||Log Rank|||PD-L1 IC1/2/3||4.32|0.65|
71709359|NCT03726879|142935957|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.27|1.22|||Log Rank|||PD-L1 IC0 Participants||1.22|0.27|
71709360|NCT03726879|142935957|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.58|2.82|||Log Rank|||ER/PgR Negative Participants||2.82|0.58|
71709361|NCT03726879|142935957|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.24|1.36|||Log Rank|||ER/PgR Positive Participants||1.36|0.24|
71709362|NCT03726879|142935958|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.38|1.32|||Log Rank|||All Participants||1.32|0.38|
71709363|NCT03726879|142935958|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.51|3.69|||Log Rank|||PD-L1 IC1/2/3||3.69|0.51|
71709364|NCT03726879|142935958|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.19|1.02|||Log Rank|||PD-L1 IC0||1.02|0.19|
71765403|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.7848||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.7848
71765404|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.0335||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0335
71765405|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.0591||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0591
71765406|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.9317||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.9317
71765407|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.0675||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.0675
71709365|NCT03726879|142935959|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|2.0|||Log Rank|||All Participants||2.00|0.40|
71709366|NCT03726879|142935959|SUPERIORITY||Hazard Ratio (HR)|1.75|||||TWO_SIDED|95.0|0.42|7.33|||Log Rank|||PD-L1 IC1/2/3||7.33|0.42|
71709367|NCT03726879|142935959|SUPERIORITY||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.21|1.59|||Log Rank|||PD-L1 IC0||1.59|0.21|
71709368|NCT03726879|142935973|SUPERIORITY||Hazard Ratio (HR)|2.38|||||TWO_SIDED|95.0|0.22|26.42|||Regression, Cox|||PIK3CA-Missing||26.42|0.22|
71709369|NCT03726879|142935973|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.9|||Regression, Cox|||PIK3CA-Mutated||1.90|0.23|
71709370|NCT03726879|142935973|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.45|1.87|||Regression, Cox|||PIK3CA-Wildtype||1.87|0.45|
71709371|NCT03726879|142935974|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.07|18.91|||Regression, Cox|||PIK3CA-Missing||18.91|0.07|
71709372|NCT03726879|142935974|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.19|1.92||||||PIK3CA-Mutated||1.92|0.19|
71709373|NCT03726879|142935974|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.33|1.55|||Regression, Cox|||PIK3CA-Wildtype||1.55|0.33|
71709374|NCT03726879|142935975|SUPERIORITY||Hazard Ratio (HR)|999.99|||||TWO_SIDED|95.0|0.0||Upper limit of the CI was not evaluable due to low number of events||Regression, Cox||The estimated value is \>999.99|PIK3CA-Missing|||0.00|
71765408|NCT00600119|143033136|SUPERIORITY_OR_OTHER|||||||0.1745||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)|||||||0.1745
71709375|NCT03726879|142935975|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.1|3.53|||Regression, Cox|||PIK3CA-Mutated||3.53|0.10|
71709376|NCT03726879|142935975|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.33|2.09|||Regression, Cox|||PIK3CA-Wildtype||2.09|0.33|
71709377|NCT03708770|142935994|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis."|The Secondary Patency rate was determined via Kaplan-Meier methods.|||
71709378|NCT03708770|142935995|OTHER|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis."|The primary patency rate was determined via Kaplan-Meier methods.|||
71709379|NCT00581100|142936003|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
71709380|NCT00581100|142936003|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709381|NCT00581100|142936004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].||||||<0.0001
71709382|NCT00581100|142936004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change = \[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709383|NCT00581100|142936005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709384|NCT00581100|142936005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709385|NCT00581100|142936005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709386|NCT00581100|142936005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = \[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709387|NCT00581100|142936006|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.007
71709388|NCT00581100|142936006|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
71709389|NCT00581100|142936006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71826702|NCT00383188|143158058|SUPERIORITY||LSM Difference|-0.196|STANDARD_ERROR_OF_MEAN|1.038||0.8501|TWO_SIDED|95.0|-2.234|1.841|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||1.841|-2.234|0.8501
71826703|NCT00383188|143158058|SUPERIORITY||LSM Difference|0.376|STANDARD_ERROR_OF_MEAN|0.904||0.6778|TWO_SIDED|95.0|-1.399|2.15|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.150|-1.399|0.6778
71886677|NCT02475655|143293592|SUPERIORITY||Mean Difference (Net)|-1.33||||0.01|TWO_SIDED|90.0|-2.16|-0.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 5.||-0.50|-2.16|0.010
71709390|NCT00581100|142936006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709391|NCT00581100|142936007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709392|NCT00581100|142936007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709393|NCT00581100|142936007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709394|NCT00581100|142936007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709395|NCT00581100|142936008|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.069
71709396|NCT00581100|142936008|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||0.006
71709397|NCT00581100|142936008|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709398|NCT00581100|142936008|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709399|NCT00581100|142936009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709400|NCT00581100|142936009|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71886678|NCT02475655|143293592|SUPERIORITY||Mean Difference (Net)|-0.17||||0.74|TWO_SIDED|90.0|-1.02|0.68||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 12.||0.68|-1.02|0.74
71709401|NCT00581100|142936010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709402|NCT00581100|142936010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709403|NCT00581100|142936010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709404|NCT00581100|142936010|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709405|NCT00581100|142936011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709406|NCT00581100|142936011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 12||||<0.001
71709407|NCT00581100|142936011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709408|NCT00581100|142936011|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||Week 24||||<0.001
71709409|NCT00581100|142936012|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709410|NCT00581100|142936012|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change-\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709411|NCT00581100|142936013|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71709412|NCT00581100|142936013|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71709413|NCT00581100|142936014|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71709414|NCT00581100|142936014|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=\[Group visit Group\*visit\].|GEE model|||||||<0.001
71709415|NCT00581100|142936015|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709416|NCT00581100|142936015|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709417|NCT00581100|142936016|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709418|NCT00581100|142936016|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709419|NCT00581100|142936017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709420|NCT00581100|142936017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<Table 8-14\> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Mixed Models Analysis|||||||<0.0001
71709421|NCT00581100|142936018|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71709422|NCT00581100|142936018|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Adjusted change calculated from mixed-model. Model for change=\[Group visit Group\*visit baseline baseline\*visit\].|Mixed Models Analysis|||||||<0.0001
71765409|NCT01270802|143033163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.76||0.67|TWO_SIDED|95.0|-0.75|2.37||P-value was not adjusted for multiple comparisons; P\<0.05 was considered statistically significant.|t-test, 2 sided|||We assumed that the declines in FMD seen with TDF/FTC/EFV in our previous study would fully reverse. Thus, the clinically relevant effect size to be detected for FMD change was +3.12% (SD 4%) in those switching from EFV to RAL. Using a two-sample, independent, two-tailed t-test with 5% type I error and 20% type II error, a sample size of 13 per group would be needed to find a difference in FMD between groups. Allowing for a 10% dropout rate, we planned to recruit 15 subjects per group.||2.37|-0.75|0.67
71886679|NCT02475655|143293593|SUPERIORITY||Mean Difference (Net)|-3.24||||0.008|TWO_SIDED|90.0|-5.22|-1.27||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.||-1.27|-5.22|0.008
71709423|NCT05170061|142936038|SUPERIORITY|||||||0.05||||||see above|t-test, 2 sided|paired analysis||Sequential analysis: if the first analysis (paired t-test to determine superiority of nebivolol/valsartan over valsartan ) reached p\< 0.05, the superiority of nebivolol over valsartan was tested (paired-t test); if the second comparison reached p \< 0.05, the superiority of nebivolol/valsartan over nebivolol was tested (paired-t test)||||0.05
71709424|NCT05170061|142936039|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||||||0.05
71709425|NCT05170061|142936040|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709426|NCT05170061|142936041|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709427|NCT05170061|142936042|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709428|NCT05170061|142936043|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709429|NCT05170061|142936044|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709430|NCT05170061|142936045|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709431|NCT05170061|142936046|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709432|NCT05170061|142936047|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709433|NCT05170061|142936048|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709434|NCT05170061|142936049|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709435|NCT05170061|142936050|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709436|NCT05170061|142936051|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709437|NCT05170061|142936052|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709438|NCT05170061|142936053|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709439|NCT05170061|142936054|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709440|NCT05170061|142936055|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709441|NCT05170061|142936056|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709442|NCT05170061|142936057|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709443|NCT05170061|142936058|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71709444|NCT05170061|142936059|SUPERIORITY|see primary dependent variable||||||0.05|||||||t-test, 2 sided|||see primary dependent variable||||0.05
71886680|NCT02475655|143293593|SUPERIORITY||Median Difference (Net)|-0.17||||0.9|TWO_SIDED|90.0|-2.38|2.05||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.||2.05|-2.38|0.90
71709445|NCT02579759|142936076|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|97.5|-0.68|-0.06|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.06|-0.68|0.008
71709446|NCT02579759|142936076|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.287|TWO_SIDED|97.5|-0.39|0.14|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.14|-0.39|0.287
71709447|NCT02579759|142936076|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.013|TWO_SIDED|97.5|-0.59|-0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||-0.03|-0.59|0.013
71709448|NCT02579759|142936076|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.05|TWO_SIDED|97.5|-0.42|0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~3. Missing value imputation: No imputation"||0.03|-0.42|0.05
71765410|NCT01270802|143033164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|5.52||0.4|TWO_SIDED|95.0|-13.04|9.77||P-value was not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.|t-test, 2 sided|||||9.77|-13.04|0.40
71709449|NCT02579759|142936076|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.31|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.31|0.013
71709450|NCT02579759|142936077|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.016|TWO_SIDED|97.5|-0.91|-0.03|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.03|-0.91|0.016
71765411|NCT02395172|143033171|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.0721|TWO_SIDED|95.0|0.71|1.05|||Log Rank|||||1.05|0.71|= 0.0721
71765412|NCT02395172|143033172|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||||1.05|0.77|
71765413|NCT02395172|143033173|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
71765414|NCT02395172|143033174|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.98|1.41||||||||1.41|0.98|
71765415|NCT02395172|143033177|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.92|2.13||||||||2.13|0.92|
71765416|NCT02395172|143033178|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.08|2.86||||||||2.86|1.08|
71765417|NCT00475982|143033227|SUPERIORITY||Mean Difference (Final Values)|0.965||||0.965|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.965
71886681|NCT02475655|143293596|SUPERIORITY||Mean Difference (Net)|1.39||||0.47|TWO_SIDED|90.0|-1.83|4.61||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 5.||4.61|-1.83|0.47
71765418|NCT00475982|143033228|SUPERIORITY||Mean Difference (Final Values)|0.884||||0.884|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.884
71765419|NCT00475982|143033229|SUPERIORITY|||||||0.294|||||||paired t-test|||intra-analysis within the weight loss arm||||0.294
71765420|NCT00475982|143033229|SUPERIORITY|||||||0.44|||||||paired t-test|||intra-analysis within the control arm||||0.440
71765421|NCT00475982|143033229|SUPERIORITY||Mean Difference (Net)|8.49||||0.186|TWO_SIDED|95.0|-4.31|21.3|||paired t-test|||analysis between the weight loss and control arms||21.3|-4.31|0.186
71765422|NCT00475982|143033230|SUPERIORITY|||||||0.162|||||||paired t-test|||intra-analysis within the weight loss arm||||0.162
71765423|NCT00475982|143033230|SUPERIORITY|||||||0.986|||||||paired t-test|||intra-analysis within the control arm||||0.986
71765424|NCT00475982|143033230|SUPERIORITY||Mean Difference (Net)|2.22||||0.353|TWO_SIDED|95.0|-2.58|7.02|||paired t-test|||analysis between the weight loss and control arms||7.02|-2.58|0.353
71765425|NCT00475982|143033231|SUPERIORITY|||||||0.283|||||||paired t-test|||intra-analysis within the weight loss arm||||0.283
71765426|NCT00475982|143033231|SUPERIORITY|||||||0.701|||||||paired t-test|||intra-analysis within the control arm||||0.701
71765427|NCT00475982|143033231|SUPERIORITY||Mean Difference (Net)|0.77||||0.835|TWO_SIDED|95.0|-6.7|8.24|||paired t-test|||analysis between the intervention and control arms||8.24|-6.70|0.835
71765428|NCT00475982|143033232|SUPERIORITY|||||||0|||||||paired t-test|||intra-analysis within the weight loss arm||||0.00
71709451|NCT02579759|142936077|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.084|TWO_SIDED|97.5|-0.65|0.08|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.08|-0.65|0.084
71709452|NCT02579759|142936077|SUPERIORITY||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.015|TWO_SIDED|95.0|-0.41|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||-0.04|-0.41|0.015
71709453|NCT02579759|142936078|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.162|TWO_SIDED|97.5|-1.01|0.23|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-1.01|0.162
71709454|NCT02579759|142936078|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.556|TWO_SIDED|97.5|-0.66|0.39|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.39|-0.66|0.556
71709455|NCT02579759|142936078|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.204|TWO_SIDED|95.0|-0.43|0.09|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.43|0.204
71709456|NCT02579759|142936079|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.36||0.232|TWO_SIDED|97.5|-1.25|0.38|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.38|-1.25|0.232
71709457|NCT02579759|142936079|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.31||0.868|TWO_SIDED|97.5|-0.74|0.64|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.64|-0.74|0.868
71709458|NCT02579759|142936079|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.322|TWO_SIDED|95.0|-0.53|0.17|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.17|-0.53|0.322
71709459|NCT02579759|142936080|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.46||0.377|TWO_SIDED|97.5|-1.43|0.62|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.62|-1.43|0.377
71709460|NCT02579759|142936080|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.38||0.334|TWO_SIDED|97.5|-1.21|0.48|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.48|-1.21|0.334
71709461|NCT02579759|142936080|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.373|TWO_SIDED|95.0|-0.62|0.23|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.23|-0.62|0.373
71709462|NCT02579759|142936084|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|97.5|-0.58|0.0|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0|-0.58|0.023
71886682|NCT02475655|143293596|SUPERIORITY||Mean Difference (Net)|2.21||||0.22|TWO_SIDED|90.0|-0.77|5.18||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 12.||5.18|-0.77|0.22
71765429|NCT00475982|143033232|SUPERIORITY|||||||0.009|||||||paired t-test|||intra-analysis within the control arm||||0.009
71765430|NCT00475982|143033232|SUPERIORITY||Mean Difference (Net)|2.11||||0.007|TWO_SIDED|95.0|0.64|3.59|||paired t-test|||analysis between the two arms||3.59|0.64|0.007
71765431|NCT00475982|143033233|SUPERIORITY|||||||0.073|||||||paired t-test|||intra-analysis within the weight loss arm||||0.073
71765432|NCT00475982|143033233|SUPERIORITY|||||||0.207|||||||paired t-test|||intra-analysis within the control arm||||0.207
71826704|NCT00383188|143158058|SUPERIORITY||LSM Difference|0.508|STANDARD_ERROR_OF_MEAN|0.877||0.5627|TWO_SIDED|95.0|-1.214|2.23|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.230|-1.214|0.5627
71709463|NCT02579759|142936084|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.162|TWO_SIDED|97.5|-0.4|0.09|||ANCOVA|||"The main analysis was performed as follows:~1. Analysis population: modified Full Analysis Set (mFAS)~2. Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~3. Missing value imputation: multiple imputation taking into account the reason of missingness"||0.09|-0.4|0.162
71709464|NCT02579759|142936088|SUPERIORITY||Odds Ratio (OR)|2.09||||0.097|TWO_SIDED|97.5|0.77|5.68|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||5.68|0.77|0.097
71709465|NCT02579759|142936088|SUPERIORITY||Odds Ratio (OR)|1.07||||0.865|TWO_SIDED|97.5|0.42|2.7|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||2.7|0.42|0.865
71709466|NCT02579759|142936089|SUPERIORITY||Odds Ratio (OR)|3.39||||0.026|TWO_SIDED|97.5|0.99|11.62|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||11.62|0.99|0.026
71709467|NCT02579759|142936089|SUPERIORITY||Odds Ratio (OR)|1.26||||0.569|TWO_SIDED|97.5|0.5|3.16|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.||3.16|0.5|0.569
71709468|NCT00677040|142936163|EQUIVALENCE|t-test to determine if tissue oxygen measurements are equivalent between treated and nontreated breast|t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71709469|NCT00677040|142936163|OTHER||t-test|0.35||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.5
71709470|NCT00456365|142936193|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71709471|NCT00456365|142936194|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71709472|NCT00456365|142936195|SUPERIORITY_OR_OTHER|||||||0.69|||||||ANOVA|||||||0.69
71709473|NCT00456365|142936196|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANCOVA|||||||0.21
71709474|NCT02202577|142936199|SUPERIORITY||Risk Ratio (RR)|0.9||||0.38|ONE_SIDED|95.0||1.35||This is the calculated p-value for the intention to treat analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||"We estimated a cesarean related surgical site infection rate of 7.5% with povidone-iodine and hypothesized chlorhexidine-alcohol treatment to be superior based on existing literature. We considered a 50% reduction to be significant. We performed our power analysis assuming~1-directional effects in favor of chlorhexidine, which best fit our hypothesis. Using a 1-tailed alpha of 0.05 and an 80% power to detect a difference, we estimated that 466 subjects would be required in each group."||1.35||0.38
71709475|NCT02202577|142936199|SUPERIORITY||Risk Ratio (RR)|0.83||||0.26|ONE_SIDED|95.0||1.25||This is the calculated p-value for the per protocol analysis of primary outcome. A 1-tailed p value of \<0.05 was selected for statistical significance.|Fisher Exact|||Per Protocol Analysis||1.25||0.26
71765433|NCT00475982|143033233|SUPERIORITY||Mean Difference (Net)|1.34||||0.063|TWO_SIDED|95.0|-0.08|2.75|||paired t-test|||analysis between the two arms||2.75|-0.08|0.063
71765434|NCT00783198|143033242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||0.0039|TWO_SIDED|95.0|-2.95|-0.57|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.57|-2.95|0.0039
71765435|NCT00783198|143033242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24||||0.0002|TWO_SIDED|95.0|-3.41|-1.07|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-1.07|-3.41|0.0002
71765436|NCT00783198|143033243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.032|TWO_SIDED|95.0|-2.08|-0.09|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.09|-2.08|0.0320
71765437|NCT00783198|143033243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.78|-0.82|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.82|-2.78|0.0003
71765438|NCT00783198|143033244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0472|TWO_SIDED|95.0|-1.54|-0.01|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.01|-1.54|0.0472
71765439|NCT00783198|143033244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0144|TWO_SIDED|95.0|-1.7|-0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.19|-1.70|0.0144
71765440|NCT00783198|143033245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.1686|TWO_SIDED|95.0|-1.11|0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.19|-1.11|0.1686
71765441|NCT00783198|143033245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0125|TWO_SIDED|95.0|-1.46|-0.18|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.18|-1.46|0.0125
71826705|NCT00383188|143158058|SUPERIORITY||LSM Difference|0.537|STANDARD_ERROR_OF_MEAN|1.038||0.6049|TWO_SIDED|95.0|-1.501|2.576|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.576|-1.501|0.6049
71886683|NCT02475655|143293597|SUPERIORITY||Mean Difference (Net)|-4.34||||0.28|TWO_SIDED|90.0|-11.0|2.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 5.||2.35|-11.0|0.28
71709476|NCT02034565|142936204|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.977|||||TWO_SIDED|90.0|0.756|1.261||||||||1.261|0.756|
71709477|NCT02034565|142936205|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.05|||||TWO_SIDED|90.0|0.938|1.176||||||||1.176|0.938|
71709478|NCT02034565|142936206|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.043|||||TWO_SIDED|90.0|0.933|1.167||||||||1.167|0.933|
71709479|NCT00829868|142936217|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|109.0||||||90.0|99.3|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|99.3|
71709480|NCT00829868|142936218|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|101.0||||||90.0|97.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|97.5|
71709481|NCT00829868|142936219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|100.0||||||90.0|96.2|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.2|
71765442|NCT00783198|143033246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0039|TWO_SIDED|95.0|-1.65|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.65|0.0039
71765443|NCT00783198|143033246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0001|TWO_SIDED|95.0|-1.95|-0.64|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.64|-1.95|0.0001
71765444|NCT04784442|143033247|SUPERIORITY|The overall Type I error rate will be controlled by performing comparison versus the placebo group starting from the highest ETC 1002 dose group by a closed testing procedure at a two-sided significance level of 0.05.|Least squares mean difference|-19.35|STANDARD_ERROR_OF_MEAN|2.768|<|0.001|TWO_SIDED|95.0|-24.81|-13.88|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.88|-24.81|<0.001
71765445|NCT04784442|143033247|SUPERIORITY||Least squares mean difference|-19.93|STANDARD_ERROR_OF_MEAN|2.798|<|0.001|TWO_SIDED|95.0|-25.45|-14.41|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 120 mg arm minus the value for the placebo arm.|||-14.41|-25.45|<0.001
71765446|NCT04784442|143033247|SUPERIORITY||Least squares mean difference|-8.67|STANDARD_ERROR_OF_MEAN|2.813||0.002|TWO_SIDED|95.0|-14.22|-3.12|||ANCOVA||||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|-3.12|-14.22|0.002
71765447|NCT03207035|143033264|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71765448|NCT03207035|143033265|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71765449|NCT03207035|143033266|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
71765450|NCT03207035|143033267|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71709482|NCT06091956|142936226|SUPERIORITY|||||||0.008|||||||McNemar|||||||0.008
71709483|NCT06091956|142936227|SUPERIORITY|||||||0.629|||||||Wilcoxon (Mann-Whitney)|||||||0.629
71709484|NCT06091956|142936230|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
71709485|NCT06091956|142936231|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71709486|NCT00967486|142936251|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71709487|NCT00803049|142936255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.2079|TWO_SIDED|95.0|0.602|1.128||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.128|0.602|0.2079
71709488|NCT00803049|142936255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.3039|TWO_SIDED|95.0|0.591|1.152||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs.Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.152|0.591|0.3039
71709489|NCT00803049|142936255|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8271|TWO_SIDED|95.0|0.736|1.26||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.260|0.736|0.8271
71765451|NCT03207035|143033268|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71765452|NCT03207035|143033269|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71765453|NCT03207035|143033270|OTHER|||||||0.53|||||||Chi-squared|||||||0.53
71765454|NCT03207035|143033271|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
71765455|NCT01252732|143033288|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|-2.7|||||TWO_SIDED|95.0|-7.5|2.0||||||||2.0|-7.5|
71765456|NCT01252732|143033289|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|2.2|||||TWO_SIDED|95.0|-2.6|7.0||||||||7.0|-2.6|
71709490|NCT00803049|142936256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.8017|TWO_SIDED|95.0|0.678|1.362||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.362|0.678|0.8017
71709491|NCT00803049|142936256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.1866|TWO_SIDED|95.0|0.559|1.117||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.117|0.559|0.1866
71709492|NCT00803049|142936256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8763|TWO_SIDED|95.0|0.767|1.357||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.||1.357|0.767|0.8763
71709493|NCT01421459|142936260|NON_INFERIORITY_OR_EQUIVALENCE|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|0.052||||0.403|TWO_SIDED|95.0|-0.07|0.175|||ANCOVA|||||0.175|-0.070|0.403
71709494|NCT01421459|142936262|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value is for 4 weeks.|ANCOVA|||||||0.382
71709495|NCT01421459|142936262|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for 8 weeks.|ANCOVA|||||||0.910
71709496|NCT01421459|142936262|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for 12 weeks.|ANCOVA|||||||0.869
71709497|NCT01421459|142936262|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for 16 weeks.|ANCOVA|||||||0.345
71709498|NCT01421459|142936262|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for 20 weeks.|ANCOVA|||||||0.161
71709499|NCT01421459|142936262|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value is for 24 weeks.|ANCOVA|||||||0.097
71709500|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is at Morning Pre-Meal at Baseline.|ANCOVA|||||||0.837
71709501|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value is for Morning 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.620
71765457|NCT01252732|143033290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority hypothesis test is a one sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two-sided 95% CI for the difference in response rates in the mITT population is greater than -10% the NI of oritavancin to vancomycin is concluded.|Difference in Proportions|0.6|||||TWO_SIDED|95.0|-3.7|5.0||||||||5.0|-3.7|
71765458|NCT04236141|143033295|SUPERIORITY||Difference in Response Rates|10.71|||||TWO_SIDED|95.0|-19.0|40.43||||||||40.43|-19.00|
71765459|NCT04236141|143033296|SUPERIORITY||Difference in Response Rates|7.14|||||TWO_SIDED|95.0|-22.03|36.31||||||||36.31|-22.03|
71886684|NCT02475655|143293597|SUPERIORITY||Mean Difference (Net)|-9.81||||0.019|TWO_SIDED|90.0|-16.6|-3.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 12.||-3.02|-16.6|0.019
71709502|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value is for Midday Pre-Meal at Baseline|ANCOVA|||||||0.107
71709503|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Midday 2 hrs PP Meal at Baseline.|ANCOVA|||||||0.258
71709504|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Evening Pre-Meal at Baseline.|ANCOVA|||||||0.161
71709505|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for Bed Time at Baseline.|ANCOVA|||||||0.725
71709506|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-value is for 0300 hrs at Baseline.|ANCOVA|||||||0.543
71709507|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.|ANCOVA|||||||0.265
71709508|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.050
71709509|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.040
71709510|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.366
71709511|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.485||95.0||||P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA|||||||0.485
71709512|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for Bed Time at Endpoint, up to 24 weeks.|ANCOVA|||||||0.537
71709513|NCT01421459|142936263|SUPERIORITY_OR_OTHER|||||||0.878||95.0||||P-value is for 0300 hrs at Endpoint, up to 24 weeks.|ANCOVA|||||||0.878
71709514|NCT01421459|142936264|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Baseline.|ANCOVA|||||||0.779
71709515|NCT01421459|142936264|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||||0.788
71709516|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value is for Baseline.|ANCOVA|||||||0.687
71709517|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value is for change at 4 wks.|ANCOVA|||||||0.036
71709518|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||P-value is for change at 8 wks.|ANCOVA|||||||0.323
71709519|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value is for change at 12 wks.|ANCOVA|||||||0.368
71709520|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for change at 16 wks.|ANCOVA|||||||0.089
71709521|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value is for change at 20 wks.|ANCOVA|||||||0.041
71765460|NCT04236141|143033297|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
71765461|NCT04236141|143033298|SUPERIORITY||Difference in Response Rates|21.43|||||TWO_SIDED|95.0|-9.44|52.3||||||||52.30|-9.44|
71709522|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||P-value is for change at 24 wks.|ANCOVA|||||||0.330
71709523|NCT01421459|142936265|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value is for change at Endpoint, up to 24 wks.|ANCOVA|||||||0.334
71765462|NCT04236141|143033299|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
71765463|NCT04236141|143033300|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-1.69|37.4||||||||37.40|-1.69|
71765464|NCT04236141|143033301|SUPERIORITY||Difference in Response Rates|17.86|||||TWO_SIDED|95.0|-12.7|48.42||||||||48.42|-12.70|
71765465|NCT04236141|143033302|SUPERIORITY||Difference in Response Rates|14.29|||||TWO_SIDED|95.0|-15.89|44.46||||||||44.46|-15.89|
71765466|NCT04236141|143033303|SUPERIORITY||Difference in Response Rates|25.0|||||TWO_SIDED|95.0|-10.38|60.38||||||||60.38|-10.38|
71765467|NCT04236141|143033304|SUPERIORITY||Difference in Response Rates|3.57|||||TWO_SIDED|95.0|-33.84|40.98||||||||40.98|-33.84|
71765468|NCT01954927|143033322|SUPERIORITY|||||||0.227||||||1-sided p-value|z-test Proportion|z-test of proportions without continuity correction||||||0.227
71765469|NCT01954927|143033323|SUPERIORITY|||||||0.897|||||||Wilcoxon (Mann-Whitney)|||||||0.897
71765470|NCT01954927|143033324|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.181
71765471|NCT01954927|143033325|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.730
71765472|NCT01954927|143033326|SUPERIORITY|||||||0.713|||||||Chi-squared|||||||0.713
71765473|NCT01954927|143033327|SUPERIORITY|||||||0.739|||||||Wilcoxon (Mann-Whitney)|||||||0.739
71765474|NCT01954927|143033328|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
71765475|NCT00955305|143033339|SUPERIORITY_OR_OTHER|||||||0.33||||||one-sided p-value using stratified logrank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.33
71765476|NCT00955305|143033340|SUPERIORITY_OR_OTHER|||||||0.95||||||two-sided p-value by stratified log rank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors||||||0.95
71765477|NCT00955305|143033341|SUPERIORITY_OR_OTHER|||||||0.15||||||two sided p-value by Fisher's exact test|Fisher Exact|||||||0.15
71765478|NCT02908490|143033427|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline FMD within that period and a term for treatment order.|Slope|-1.42||||0.185|TWO_SIDED|95.0|-3.54|0.68||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.68|-3.54|0.185
71765479|NCT02908490|143033428|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline EndoPAT within that period and a term for treatment order.|Slope|0.2||||0.003|TWO_SIDED|95.0|0.069|0.331||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||0.331|0.069|0.003
71765480|NCT02908490|143033434|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|7.63||||0.061|TWO_SIDED|95.0|-0.36|15.63||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||15.63|-0.36|0.061
71765481|NCT02908490|143033435|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|55.3||||0.011|TWO_SIDED|95.0|12.79|97.81||The a prior threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||97.81|12.79|0.011
71765482|NCT02908490|143033436|SUPERIORITY|Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline biomarker within that period and a term for treatment order.|Slope|74.93||||0.077|TWO_SIDED|95.0|-7.98|157.84||The a priori threshold for statistical significance was \<0.05.|Mixed Models Analysis|||||157.84|-7.98|0.077
71765483|NCT03467152|143033445|SUPERIORITY|||||||0.6909||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6909
71765484|NCT03467152|143033446|SUPERIORITY||Odds Ratio (OR)|1.018||||0.8251|TWO_SIDED|95.0|0.695|1.492||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.492|0.695|0.8251
71765485|NCT03467152|143033447|SUPERIORITY||Odds Ratio (OR)|0.853||||0.3003|TWO_SIDED|95.0|0.584|1.247||Generalized Linear Mixed Models Analysis (GLMM)|GLMM|||||1.247|0.584|0.3003
71765486|NCT03467152|143033448|SUPERIORITY|||||||0.9198||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.9198
71765487|NCT03467152|143033449|SUPERIORITY|||||||0.2909|||||||ANCOVA|||||||0.2909
71765488|NCT03467152|143033450|SUPERIORITY|||||||0.6127||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.6127
71765489|NCT03467152|143033451|SUPERIORITY|||||||0.878||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8780
71765490|NCT03467152|143033452|SUPERIORITY|||||||0.409||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.4090
71765491|NCT03467152|143033453|SUPERIORITY|||||||0.8736||||||Mixed Models for Repeated Measures Analysis (MMRM)|MMRM|||||||0.8736
71709524|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Behavior domain at 4 weeks.|ANCOVA|||||||0.726
71709525|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for Behavior domain at 12 weeks.|ANCOVA|||||||0.502
71709526|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.437||95.0||||P-value is for Behavior domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.437
71709527|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||P-value is for Worry domain at 4 weeks.|ANCOVA|||||||0.237
71709528|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||P-value is for Worry domain at 12 weeks.|ANCOVA|||||||0.860
71709529|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for Worry domain at Endpoint, up to 24 weeks.|ANCOVA|||||||0.966
71826706|NCT00383188|143158058|SUPERIORITY||LSM Difference|0.51|STANDARD_ERROR_OF_MEAN|1.068||0.6332|TWO_SIDED|95.0|-1.587|2.608|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline swollen joint count as the covariate and participant as a random effect.||2.608|-1.587|0.6332
71709530|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||P-value is for ALBSS Total Score at 4 weeks.|ANCOVA|||||||0.313
71709531|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||P-value is for ALBSS Total Score at 12 weeks.|ANCOVA|||||||0.683
71709532|NCT01421459|142936266|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.765
71709533|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for Inconvenience of Regimen at 4 weeks.|ANCOVA|||||||0.983
71709534|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Inconvenience of Regimen at 12 weeks.|ANCOVA|||||||0.371
71709535|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.757||95.0||||P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.|ANCOVA|||||||0.757
71709536|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||P-value is for Lifestyle Flexibility at 4 weeks.|ANCOVA|||||||0.890
71709537|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||P-value is for Lifestyle Flexibility at 12 weeks.|ANCOVA|||||||0.326
71826707|NCT00383188|143158059|SUPERIORITY||LSM Difference|-2.802|STANDARD_ERROR_OF_MEAN|4.098||0.4943|TWO_SIDED|95.0|-10.85|5.243|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.243|-10.85|0.4943
71709538|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.|ANCOVA|||||||0.831
71709539|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value is for Hypoglycemic Control at 4 weeks.|ANCOVA|||||||0.507
71709540|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Hypoglycemic Control at 12 weeks.|ANCOVA|||||||0.690
71709541|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.307
71709542|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Glycemic Control at 4 weeks.|ANCOVA|||||||0.902
71709543|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||P-value is for Glycemic Control at 12 weeks.|ANCOVA|||||||0.109
71709544|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value is for Glycemic Control at Endpoint, up to 24 weeks.|ANCOVA|||||||0.754
71709545|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||P-value is for Insulin Deliver Device at 4 weeks.|ANCOVA|||||||0.088
71709546|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||P-value is for Insulin Delivery Device at 12 weeks.|ANCOVA|||||||0.456
71709547|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.|ANCOVA|||||||0.531
71709548|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value is for ITSQ Total Score at 4 weeks.|ANCOVA|||||||0.393
71709549|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||P-value is for ITSQ Total Score at 12 weeks.|ANCOVA|||||||0.296
71709550|NCT01421459|142936267|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.|ANCOVA|||||||0.662
71709551|NCT01421459|142936268|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||ANCOVA|||||||0.393
71709552|NCT01421459|142936269|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value is for Insulin Dose at Endpoint, up to 24 weeks.|ANOVA|||||||0.185
71709553|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||P-value is for HbA1c \<7% at Baseline.|Chi-squared|||||||0.661
71709554|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value is for HbA1c ≤ 6.5% at Baseline.|Chi-squared|||||||0.394
71709555|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-value is for HbA1c \<7% at 4 weeks.|Chi-squared|||||||0.688
71709556|NCT01421459|142936270|SUPERIORITY_OR_OTHER||||||>|0.999||95.0||||P-value is for HbA1c ≤ 6.5% at 4 weeks.|Chi-squared|||||||>0.999
71709557|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.409||95.0||||P-value is for HbA1c \<7% at 8 weeks.|Chi-squared|||||||0.409
71709558|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for HbA1c ≤ 6.5% at 8 weeks.|Chi-squared|||||||0.090
71709559|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value is for HbA1c \<7% at 12 weeks.|Chi-squared|||||||0.319
71709560|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-value is for HbA1c ≤6.5% at 12 weeks.|Chi-squared|||||||0.463
71709561|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for HbA1c \<7% at 16 weeks.|Chi-squared|||||||0.128
71709562|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value is for HbA1c ≤6.5% at 16 weeks.|Chi-squared|||||||0.261
71709563|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is for HbA1c \<7% at 20 weeks.|Chi-squared|||||||0.218
71709564|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for HbA1c ≤6.5% at 20 weeks.|Chi-squared|||||||0.092
71709565|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value is for HbA1c \<7%% at 24 weeks.|Chi-squared|||||||0.186
71709566|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for HbA1c ≤6.5% at 24 weeks.|Chi-squared|||||||0.174
71709567|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value is for HbA1c \<7% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.340
71709568|NCT01421459|142936270|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.|Chi-squared|||||||0.293
71709569|NCT01421459|142936271|SUPERIORITY_OR_OTHER|||||||0.594||95.0||||P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.594
71709570|NCT01421459|142936271|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared|||||||0.462
71709571|NCT01421459|142936272|SUPERIORITY_OR_OTHER|||||||0.995||95.0||||P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.995
71826708|NCT00383188|143158059|SUPERIORITY||LSM Difference|-10.19|STANDARD_ERROR_OF_MEAN|4.026||0.0116|TWO_SIDED|95.0|-18.09|-2.283|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.283|-18.09|0.0116
71826709|NCT00383188|143158059|SUPERIORITY||LSM Difference|-12.73|STANDARD_ERROR_OF_MEAN|4.71||0.007|TWO_SIDED|95.0|-21.98|-3.485|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.485|-21.98|0.0070
71826710|NCT00383188|143158059|SUPERIORITY||LSM Difference|-11.14|STANDARD_ERROR_OF_MEAN|4.812||0.0209|TWO_SIDED|95.0|-20.58|-1.688|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-1.688|-20.58|0.0209
71826711|NCT00383188|143158059|SUPERIORITY||LSM Difference|-7.439|STANDARD_ERROR_OF_MEAN|4.056||0.0671|TWO_SIDED|95.0|-15.4|0.524|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.524|-15.40|0.0671
71709572|NCT01421459|142936272|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)|||||||0.686
71709573|NCT01421459|142936273|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-value is for Baseline.|Chi-squared|||||||0.285
71886685|NCT02475655|143293598|SUPERIORITY||Mean Difference (Net)|-0.81||||0.55|TWO_SIDED|90.0|-3.02|1.41||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 5.||1.41|-3.02|0.55
71709574|NCT01421459|142936273|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.047
71709575|NCT01421459|142936273|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.882
71709576|NCT01421459|142936273|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.179
71709577|NCT01421459|142936273|SUPERIORITY_OR_OTHER|||||||0.314||95.0||||P-value is for Endpoint, up to 24 weeks.|Chi-squared|||||||0.314
71709578|NCT01421459|142936273|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value is for Baseline to 24 weeks (Overall).|Chi-squared|||||||0.100
71709579|NCT01421459|142936274|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value is for 4 weeks.|Chi-squared|||||||0.176
71709580|NCT01421459|142936274|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||P-value is for 12 weeks.|Chi-squared|||||||0.999
71709581|NCT01421459|142936274|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-value is for 24 weeks.|Chi-squared|||||||0.618
71709582|NCT01421459|142936274|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||P-value is for Endpoint (LOCF).|Chi-squared|||||||0.874
71709583|NCT01421459|142936274|SUPERIORITY_OR_OTHER||||||>|0.233||95.0||||P-value is for Overall (Baseline to 24 weeks).|Chi-squared|||||||>0.233
71709584|NCT04439903|142936282|OTHER||Intercept|1.9726|STANDARD_ERROR_OF_MEAN|3.8238||0.61532|TWO_SIDED||||||Regression, Linear|||||||0.61532
71709585|NCT04439903|142936282|OTHER||Slope|-0.68016|STANDARD_ERROR_OF_MEAN|1.0084||0.5128|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.5128
71709586|NCT04439903|142936282|OTHER||Slope|0.15238|STANDARD_ERROR_OF_MEAN|0.3629||0.68197|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.68197
71709587|NCT04439903|142936283|OTHER||Intercept|-0.49527|STANDARD_ERROR_OF_MEAN|0.44535||0.28789|TWO_SIDED||||||Regression, Linear|||||||0.28789
71709588|NCT04439903|142936283|OTHER||Slope|0.16785|STANDARD_ERROR_OF_MEAN|0.11745||0.17848|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.17848
71709589|NCT04439903|142936283|OTHER||Slope|-0.06091|STANDARD_ERROR_OF_MEAN|0.042266||0.17514|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.17514
71709590|NCT04439903|142936284|OTHER||Intercept|-0.28825|STANDARD_ERROR_OF_MEAN|0.59949||0.63929|TWO_SIDED||||||Regression, Linear|||||||0.63929
71709591|NCT04439903|142936284|OTHER||Slope|-0.14422|STANDARD_ERROR_OF_MEAN|0.1581||0.37964|TWO_SIDED||||||Regression, Linear||Predictor variable 1: Number of simulations per participant per week.|||||0.37964
71709592|NCT04439903|142936284|OTHER||Slope|0.06718|STANDARD_ERROR_OF_MEAN|0.056895||0.26057|TWO_SIDED||||||Regression, Linear||Predictor variable 2: Minutes of interaction with the Web-Based Simulation Tool per participant per week.|||||0.26057
71709593|NCT04003142|142936295|SUPERIORITY|Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)|Least squares (LS) Mean difference|-1.82|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.73|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.91|-2.73|<0.001
71709594|NCT04003142|142936295|SUPERIORITY||LSMean difference|-2.55|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.45|-1.64||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.64|-3.45|<0.001
71709595|NCT04003142|142936295|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71709596|NCT04003142|142936295|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71826712|NCT00383188|143158059|SUPERIORITY||LSM Difference|-10.46|STANDARD_ERROR_OF_MEAN|3.986||0.0089|TWO_SIDED|95.0|-18.28|-2.632|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.632|-18.28|0.0089
71826713|NCT00383188|143158059|SUPERIORITY||LSM Difference|-14.1|STANDARD_ERROR_OF_MEAN|4.657||0.0025|TWO_SIDED|95.0|-23.24|-4.959|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-4.959|-23.24|0.0025
71826714|NCT00383188|143158059|SUPERIORITY||LSM Difference|-7.876|STANDARD_ERROR_OF_MEAN|4.774||0.0994|TWO_SIDED|95.0|-17.25|1.496|||ANCOVA|||Week 2:Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.496|-17.25|0.0994
71826715|NCT00383188|143158059|SUPERIORITY||LSM Difference|-1.964|STANDARD_ERROR_OF_MEAN|4.056||0.6284|TWO_SIDED|95.0|-9.926|5.999|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||5.999|-9.926|0.6284
71886686|NCT02475655|143293598|SUPERIORITY||Mean Difference (Net)|-1.7||||0.09|TWO_SIDED|90.0|-3.36|-0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 12.||-0.04|-3.36|0.09
71886687|NCT02475655|143293599|SUPERIORITY||Mean Difference (Net)|-1.47||||0.15|TWO_SIDED|90.0|-3.17|0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 5.||0.23|-3.17|0.15
71655417|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.08|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-6.7|0.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-6.7|
71655418|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.63|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-5.3|2.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.0|-5.3|
71655419|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.8554|||TWO_SIDED|95.0|-3.5|3.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-3.5|
71655420|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.8555|||TWO_SIDED|95.0|-3.0|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-3.0|
71655421|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|1.8557|||TWO_SIDED|95.0|-4.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.8|
71655422|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.34|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-5.0|2.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-5.0|
71709597|NCT04003142|142936296|SUPERIORITY||LSMean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.55|<|0.001||95.0|-2.94|-0.78||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.78|-2.94|<0.001
71709598|NCT04003142|142936296|SUPERIORITY||LSMean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.6|-1.46||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.46|-3.60|<0.001
71709599|NCT04003142|142936296|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71709600|NCT04003142|142936296|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71826716|NCT00383188|143158059|SUPERIORITY||LSM Difference|-9.934|STANDARD_ERROR_OF_MEAN|3.986||0.0129|TWO_SIDED|95.0|-17.76|-2.109|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.109|-17.76|0.0129
71826717|NCT00383188|143158059|SUPERIORITY||LSM Difference|-8.097|STANDARD_ERROR_OF_MEAN|4.656||0.0825|TWO_SIDED|95.0|-17.24|1.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.044|-17.24|0.0825
71886688|NCT02475655|143293599|SUPERIORITY||Mean Difference (Net)|-1.62||||0.37|TWO_SIDED|90.0|-4.59|1.35||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 12.||1.35|-4.59|0.37
71709601|NCT04003142|142936297|SUPERIORITY||LSMean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.021||95.0|-0.27|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.02|-0.27|0.021
71709602|NCT04003142|142936297|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001||95.0|-0.41|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.16|-0.41|<0.001
71709603|NCT04003142|142936297|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71709604|NCT04003142|142936297|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71709605|NCT04003142|142936298|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.049||95.0|-0.33|0.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.00|-0.33|0.049
71709606|NCT04003142|142936298|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.45|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.13|-0.45|<0.001
71709607|NCT04003142|142936298|SUPERIORITY|||||||0.049|||||||Hochberg|||||||0.049
71709608|NCT04003142|142936298|SUPERIORITY||||||<|0.001|||||||Hochberg|||||||<0.001
71709609|NCT04003142|142936299|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.381|TWO_SIDED|95.0|-2.1|0.8||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.8|-2.1|0.381
71709610|NCT04003142|142936299|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.007|TWO_SIDED|95.0|-3.5|-0.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.6|-3.5|0.007
71709611|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.09|-0.51||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.51|-2.09|0.001
71709612|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.4|<|0.001||95.0|-2.51|-0.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.91|-2.51|<0.001
71709613|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.65|-0.87||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.87|-2.65|<0.001
71709614|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|-2.86|-1.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.08|-2.86|<0.001
71709615|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-2.63|-0.84||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.84|-2.63|<0.001
71886689|NCT02475655|143293600|SUPERIORITY||Mean Difference (Net)|-0.86||||0.39|TWO_SIDED|90.0|-2.51|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 5.||0.80|-2.51|0.39
71826718|NCT00383188|143158059|SUPERIORITY||LSM Difference|-1.907|STANDARD_ERROR_OF_MEAN|4.774||0.6897|TWO_SIDED|95.0|-11.28|7.465|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||7.465|-11.28|0.6897
71826719|NCT00383188|143158059|SUPERIORITY||LSM Difference|1.861|STANDARD_ERROR_OF_MEAN|4.055||0.6465|TWO_SIDED|95.0|-6.1|9.821|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||9.821|-6.100|0.6465
71709616|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|-3.29|-1.5||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.50|-3.29|<0.001
71709617|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.48|<|0.001||95.0|-2.79|-0.9||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.90|-2.79|<0.001
71709618|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.61|-1.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.72|-3.61|<0.001
71709619|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.78|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.71|-0.85||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.85|-2.71|<0.001
71709620|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.47|<|0.001||95.0|-3.59|-1.73||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.73|-3.59|<0.001
71709621|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-2.77|-0.83||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.83|-2.77|<0.001
71709622|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.49|<|0.001||95.0|-3.3|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.37|-3.30|<0.001
71709623|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.79|-0.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.74|-2.79|<0.001
71709624|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.38|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-3.4|-1.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.35|-3.40|<0.001
71709625|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.65|STANDARD_ERROR_OF_MEAN|0.54||0.002||95.0|-2.71|-0.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.59|-2.71|0.002
71709626|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.51|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-3.57|-1.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.45|-3.57|<0.001
71709627|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.54|<|0.001||95.0|-2.96|-0.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.86|-2.96|<0.001
71709628|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-3.69|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.60|-3.69|<0.001
71709629|NCT04003142|142936300|SUPERIORITY||LSMean difference|-1.86|STANDARD_ERROR_OF_MEAN|0.53|<|0.001||95.0|-2.91|-0.81||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.81|-2.91|<0.001
71709630|NCT04003142|142936300|SUPERIORITY||LSMean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.61|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.52|-3.61|<0.001
71765492|NCT01236547|143033461|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2831|TWO_SIDED|95.0|0.52|1.43||One-sided significance level = 0.1379|Log Rank||Reference arm = placebo|Assuming hazard ratio (pazopanib/placebo) of 0.625 (1-year 19% vs. 35.4%), 1-sided alpha 0.15, logrank test, 80% power, 1 interim analysis, required 71 deaths in 79 eligible patients (88 allowing 10% ineligible) in original design. The protocol was amended for phase II final analysis to be performed after all phase II eligible participants were potentially followed for 3 years with 1-sided alpha 0.1379, providing 77% power. See Limitations and Caveats||1.43|0.52|0.2831
71765493|NCT01236547|143033463|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.688|TWO_SIDED|95.0|0.55|2.67|||Log Rank|One-sided significance level = 0.15|Reference arm = placebo|||2.67|0.55|0.6880
71765494|NCT01236547|143033464|SUPERIORITY|||||||0.1921||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.1921
71886690|NCT02475655|143293600|SUPERIORITY||Mean Difference (Net)|-0.7||||0.54|TWO_SIDED|90.0|-2.59|1.19||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 12.||1.19|-2.59|0.54
71655423|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.84|STANDARD_ERROR_OF_MEAN|1.8566|||TWO_SIDED|95.0|-4.5|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-4.5|
71655424|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-4.7|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-4.7|
71655425|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-7.6|-0.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.4|-7.6|
71655426|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.43|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-6.0|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-6.0|
71655427|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-4.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-4.9|
71655428|NCT02037165|142829267|SUPERIORITY_OR_OTHER||Slope|-1.72|STANDARD_ERROR_OF_MEAN|1.825|||TWO_SIDED|95.0|-5.3|1.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-5.3|
71655429|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.8251|||TWO_SIDED|95.0|-3.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-3.8|
71709631|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.001||95.0|-0.21|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.05|-0.21|0.001
71709632|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.24|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.08|-0.24|<0.001
71709633|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001||95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
71765495|NCT01236547|143033465|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
71765496|NCT01236547|143033466|SUPERIORITY|||||||1|||||||Fisher Exact|Two-sided significance level = 0.05||||||1.00
71709634|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.28|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.07|-0.28|0.001
71826720|NCT00383188|143158059|SUPERIORITY||LSM Difference|-10.65|STANDARD_ERROR_OF_MEAN|3.985||0.0077|TWO_SIDED|95.0|-18.47|-2.824|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-2.824|-18.47|0.0077
71826721|NCT00383188|143158059|SUPERIORITY||LSM Difference|-7.927|STANDARD_ERROR_OF_MEAN|4.655||0.089|TWO_SIDED|95.0|-17.07|1.213|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||1.213|-17.07|0.0890
71826722|NCT00383188|143158059|SUPERIORITY||LSM Difference|-5.964|STANDARD_ERROR_OF_MEAN|4.773||0.2119|TWO_SIDED|95.0|-15.33|3.406|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.406|-15.33|0.2119
71826723|NCT00383188|143158059|SUPERIORITY||LSM Difference|-4.766|STANDARD_ERROR_OF_MEAN|4.053||0.2401|TWO_SIDED|95.0|-12.72|3.191|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||3.191|-12.72|0.2401
71826724|NCT00383188|143158059|SUPERIORITY||LSM Difference|-11.07|STANDARD_ERROR_OF_MEAN|3.983||0.0056|TWO_SIDED|95.0|-18.89|-3.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-3.251|-18.89|0.0056
71826725|NCT00383188|143158059|SUPERIORITY||LSM Difference|-8.885|STANDARD_ERROR_OF_MEAN|4.654||0.0566|TWO_SIDED|95.0|-18.02|0.251|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||0.251|-18.02|0.0566
71826726|NCT00383188|143158059|SUPERIORITY||LSM Difference|-10.09|STANDARD_ERROR_OF_MEAN|4.772||0.0348|TWO_SIDED|95.0|-19.45|-0.72|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||-0.720|-19.45|0.0348
71709635|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.067||95.0|-0.23|0.01||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||0.01|-0.23|0.067
71709636|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.35|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.11|-0.35|<0.001
71826727|NCT00383188|143158059|SUPERIORITY||LSM Difference|4.89|STANDARD_ERROR_OF_MEAN|4.191||0.2436|TWO_SIDED|95.0|-3.336|13.116|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.116|-3.336|0.2436
71826728|NCT00383188|143158059|SUPERIORITY||LSM Difference|-1.781|STANDARD_ERROR_OF_MEAN|4.066||0.6616|TWO_SIDED|95.0|-9.762|6.201|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||6.201|-9.762|0.6616
71826729|NCT00383188|143158059|SUPERIORITY||LSM Difference|3.907|STANDARD_ERROR_OF_MEAN|4.83||0.4189|TWO_SIDED|95.0|-5.574|13.388|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||13.388|-5.574|0.4189
71826730|NCT00383188|143158059|SUPERIORITY||LSM Difference|4.395|STANDARD_ERROR_OF_MEAN|4.942||0.3741|TWO_SIDED|95.0|-5.305|14.096|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Assessment of Arthritis Pain (VAS) count as the covariate and participant as a random effect.||14.096|-5.305|0.3741
71826731|NCT00383188|143158060|SUPERIORITY||LSM Difference|-2.996|STANDARD_ERROR_OF_MEAN|3.958||0.4493|TWO_SIDED|95.0|-10.77|4.773|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.773|-10.77|0.4493
71709637|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED|95.0|-0.3|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.03|-0.30|0.020
71709638|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.16|-0.43|<0.001
71709639|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.012|TWO_SIDED|95.0|-0.32|-0.04||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.04|-0.32|0.012
71709640|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.42|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.14|-0.42|<0.001
71765497|NCT00412373|143033479|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.6||0.774||95.0|-2.7|3.7|||ANOVA|P-value based on the actual value and was from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|Paliperidone Extended Release (ER) - Placebo on the Actual Score.|||3.7|-2.7|0.774
71765498|NCT00412373|143033480|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-13.8|-4.9|||ANCOVA|P-values are from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-4.9|-13.8|<0.001
71765499|NCT00412373|143033481|SUPERIORITY_OR_OTHER||LS Means Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.4|-1.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.2|-4.4|<0.001
71765500|NCT00412373|143033482|SUPERIORITY_OR_OTHER||LS Means Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.1|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.8|-3.1|<0.001
71765501|NCT00412373|143033483|SUPERIORITY_OR_OTHER||LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.3|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.3|-6.8|<0.001
71765502|NCT00412373|143033484|SUPERIORITY_OR_OTHER||LS Means Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|-4.2|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.1|-4.2|<0.001
71765503|NCT00412373|143033485|SUPERIORITY_OR_OTHER||LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.3|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-3.3|<0.001
71765504|NCT00412373|143033486|SUPERIORITY_OR_OTHER||LS Means Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.001||95.0|-2.9|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.9|-2.9|<0.001
71765505|NCT00412373|143033487|SUPERIORITY_OR_OTHER||LS Means Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.001||95.0|-2.6|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.6|-2.6|0.001
71765506|NCT00412373|143033488|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.016||95.0|-1.8|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-1.8|0.016
71765507|NCT00412373|143033490|SUPERIORITY_OR_OTHER||LS Means Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1||0.002||95.0|-0.7|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-0.2|-0.7|0.002
71765508|NCT00412373|143033491|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANOVA|P-value is from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.||||-0.3|-0.9|<0.001
71765509|NCT00412373|143033492|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.046
71765510|NCT00412373|143033494|SUPERIORITY_OR_OTHER||LS Means Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.4|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-1.7|-6.4|<0.001
71765511|NCT00412373|143033496|SUPERIORITY_OR_OTHER||LS Means Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.5||0.001||95.0|-7.7|-2.0|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.|||-2.0|-7.7|0.001
71765512|NCT02871882|143033497|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71765513|NCT00797966|143033527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.6551|TWO_SIDED|95.0|-2.87|1.81|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.81|-2.87|0.6551
71765514|NCT00797966|143033527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.7037|TWO_SIDED|95.0|-2.3|1.55|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||1.55|-2.30|0.7037
71765515|NCT00797966|143033527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.0303|TWO_SIDED|95.0|-4.08|-0.21|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg's procedure for handling the two primary efficacy comparisons.||-0.21|-4.08|0.0303
71765516|NCT00797966|143033528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4166|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo|||0.18|-0.43|0.4166
71765517|NCT00797966|143033528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4193|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.15|-0.35|0.4193
71765518|NCT00797966|143033528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0064|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.10|-0.60|0.0064
71826732|NCT00383188|143158060|SUPERIORITY||LSM Difference|-14.45|STANDARD_ERROR_OF_MEAN|3.891||0.0002|TWO_SIDED|95.0|-22.08|-6.807|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-6.807|-22.08|0.0002
71826733|NCT00383188|143158060|SUPERIORITY||LSM Difference|-11.54|STANDARD_ERROR_OF_MEAN|4.522||0.0109|TWO_SIDED|95.0|-20.42|-2.661|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.661|-20.42|0.0109
71826734|NCT00383188|143158060|SUPERIORITY||LSM Difference|-7.364|STANDARD_ERROR_OF_MEAN|4.651||0.1137|TWO_SIDED|95.0|-16.49|1.765|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.765|-16.49|0.1137
71886691|NCT02475655|143293601|SUPERIORITY||Mean Difference (Net)|-6.02||||0.1|TWO_SIDED|90.0|-12.0|-0.06||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 5.||-0.06|-12.0|0.10
71886692|NCT02475655|143293601|SUPERIORITY||Mean Difference (Net)|-6.39||||0.026|TWO_SIDED|90.0|-11.1|-1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 12.||-1.73|-11.1|0.026
71765519|NCT00797966|143033529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68||||0.449|TWO_SIDED|95.0|-2.67|6.02|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||6.02|-2.67|0.4490
71765520|NCT00797966|143033529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.7412|TWO_SIDED|95.0|-3.02|4.24|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||4.24|-3.02|0.7412
71765521|NCT00797966|143033529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54||||0.407|TWO_SIDED|95.0|-2.1|5.17|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||5.17|-2.10|0.4070
71765522|NCT00797966|143033530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.4954|TWO_SIDED|95.0|-0.86|0.42|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.42|-0.86|0.4954
71765523|NCT00797966|143033530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4902|TWO_SIDED|95.0|-0.73|0.35|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.35|-0.73|0.4902
71765524|NCT00797966|143033530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0161|TWO_SIDED|95.0|-1.2|-0.12|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||-0.12|-1.20|0.0161
71765525|NCT00797966|143033536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.5953|TWO_SIDED|95.0|-2.54|1.46|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.46|-2.54|0.5953
71765526|NCT00797966|143033536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.9479|TWO_SIDED|95.0|-1.66|1.55|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||1.55|-1.66|0.9479
71826735|NCT00383188|143158060|SUPERIORITY||LSM Difference|-3.989|STANDARD_ERROR_OF_MEAN|3.915||0.3086|TWO_SIDED|95.0|-11.68|3.697|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.697|-11.68|0.3086
71826736|NCT00383188|143158060|SUPERIORITY||LSM Difference|-8.357|STANDARD_ERROR_OF_MEAN|3.85||0.0303|TWO_SIDED|95.0|-15.92|-0.799|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.799|-15.92|0.0303
71886693|NCT02475655|143293602|SUPERIORITY||Mean Difference (Net)|0.28||||0.95|TWO_SIDED|90.0|-7.26|7.82||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 5.||7.82|-7.26|0.95
71709641|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.31|-0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.02|-0.31|0.030
71709642|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.14|-0.43|<0.001
71709643|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.095|TWO_SIDED|95.0|-0.28|0.02||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||0.02|-0.28|0.095
71709644|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.41|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.41|<0.001
71709645|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.109|TWO_SIDED|95.0|-0.28|0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||0.03|-0.28|0.109
71709646|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.43|<0.001
71709647|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02||95.0|-0.35|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.03|-0.35|0.020
71709648|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.15|-0.47|<0.001
71826737|NCT00383188|143158060|SUPERIORITY||LSM Difference|-10.66|STANDARD_ERROR_OF_MEAN|4.489||0.0178|TWO_SIDED|95.0|-19.47|-1.845|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.845|-19.47|0.0178
71826738|NCT00383188|143158060|SUPERIORITY||LSM Difference|-5.325|STANDARD_ERROR_OF_MEAN|4.612||0.2486|TWO_SIDED|95.0|-14.38|3.729|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.729|-14.38|0.2486
71826739|NCT00383188|143158060|SUPERIORITY||LSM Difference|-2.965|STANDARD_ERROR_OF_MEAN|3.915||0.4491|TWO_SIDED|95.0|-10.65|4.72|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.720|-10.65|0.4491
71826740|NCT00383188|143158060|SUPERIORITY||LSM Difference|-10.23|STANDARD_ERROR_OF_MEAN|3.85||0.0081|TWO_SIDED|95.0|-17.79|-2.671|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.671|-17.79|0.0081
71709649|NCT04003142|142936301|SUPERIORITY||LSMean diferrence|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012||95.0|-0.37|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.05|-0.37|0.012
71709650|NCT04003142|142936301|SUPERIORITY||LSMean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001||95.0|-0.47|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.15|-0.47|<0.001
71709651|NCT04003142|142936302|SUPERIORITY||LSMean difference|-12.16|STANDARD_ERROR_OF_MEAN|3.43|<|0.001||95.0|-18.9|-5.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.43|-18.90|<0.001
71709652|NCT04003142|142936302|SUPERIORITY||LSMean difference|-15.68|STANDARD_ERROR_OF_MEAN|3.44|<|0.001||95.0|-22.44|-8.91||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-8.91|-22.44|<0.001
71765527|NCT00797966|143033536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0919|TWO_SIDED|95.0|-2.95|0.22|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.|||0.22|-2.95|0.0919
71826741|NCT00383188|143158060|SUPERIORITY||LSM Difference|-9.291|STANDARD_ERROR_OF_MEAN|4.488||0.0388|TWO_SIDED|95.0|-18.1|-0.48|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.480|-18.10|0.0388
71709653|NCT04003142|142936302|SUPERIORITY||LSMean difference|-14.61|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-22.09|-7.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-7.13|-22.09|<0.001
71709654|NCT04003142|142936302|SUPERIORITY||LSMean difference|-15.95|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-23.45|-8.45||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-8.45|-23.45|<0.001
71709655|NCT04003142|142936302|SUPERIORITY||LSMean difference|-15.51|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-23.16|-7.86||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-7.86|-23.16|<0.001
71709656|NCT04003142|142936302|SUPERIORITY||LSMean difference|-20.25|STANDARD_ERROR_OF_MEAN|3.9|<|0.001||95.0|-27.91|-12.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-12.59|-27.91|<0.001
71709657|NCT04003142|142936302|SUPERIORITY||LSMean difference|-16.34|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-24.04|-8.63||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-8.63|-24.04|<0.001
71709658|NCT04003142|142936302|SUPERIORITY||LSMean difference|-21.65|STANDARD_ERROR_OF_MEAN|3.92|<|0.001||95.0|-29.36|-13.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.94|-29.36|<0.001
71709659|NCT04003142|142936302|SUPERIORITY||LSMean difference|-15.62|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-23.27|-7.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-7.98|-23.27|<0.001
71709660|NCT04003142|142936302|SUPERIORITY||LSMean difference|-22.88|STANDARD_ERROR_OF_MEAN|3.89|<|0.001||95.0|-30.52|-15.24||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-15.24|-30.52|<0.001
71709661|NCT04003142|142936302|SUPERIORITY||LSMean difference|-14.78|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-22.38|-7.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-7.19|-22.38|<0.001
71709662|NCT04003142|142936302|SUPERIORITY||LSMean difference|-22.66|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-30.25|-15.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-15.07|-30.25|<0.001
71709663|NCT04003142|142936302|SUPERIORITY||LSMean difference|-14.97|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-22.86|-7.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-7.09|-22.86|<0.001
71709664|NCT04003142|142936302|SUPERIORITY||LSMean difference|-21.47|STANDARD_ERROR_OF_MEAN|4.01|<|0.001||95.0|-29.34|-13.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.60|-29.34|<0.001
71709665|NCT04003142|142936302|SUPERIORITY||LSMean difference|-14.38|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-22.33|-6.43||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-6.43|-22.33|<0.001
71709666|NCT04003142|142936302|SUPERIORITY||LSMean difference|-20.57|STANDARD_ERROR_OF_MEAN|4.03|<|0.001||95.0|-28.5|-12.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.65|-28.50|<0.001
71709667|NCT04003142|142936302|SUPERIORITY||LSMean difference|-12.14|STANDARD_ERROR_OF_MEAN|4.07||0.003||95.0|-20.14|-4.14||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-4.14|-20.14|0.003
71765528|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.3998||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.3998
71826742|NCT00383188|143158060|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.611||0.588|TWO_SIDED|95.0|-11.55|6.553|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.553|-11.55|0.5880
71826743|NCT00383188|143158060|SUPERIORITY||LSM Difference|3.78|STANDARD_ERROR_OF_MEAN|3.914||0.3345|TWO_SIDED|95.0|-3.904|11.464|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||11.464|-3.904|0.3345
71709668|NCT04003142|142936302|SUPERIORITY||LSMean difference|-19.73|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.71|-11.755||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-11.755|-27.71|<0.001
71709669|NCT04003142|142936302|SUPERIORITY||LSMean difference|-14.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-22.25|-6.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-6.54|-22.25|<0.001
71709670|NCT04003142|142936302|SUPERIORITY||LSMean difference|-20.1|STANDARD_ERROR_OF_MEAN|3.98|<|0.001||95.0|-27.93|-12.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-12.27|-27.93|<0.001
71709671|NCT04003142|142936302|SUPERIORITY||LSMean difference|-14.96|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-22.96|-6.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-6.96|-22.96|<0.001
71709672|NCT04003142|142936302|SUPERIORITY||LSMean difference|-20.15|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.13|-12.18||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.18|-28.13|<0.001
71709673|NCT04003142|142936302|SUPERIORITY||LSMean difference|-13.64|STANDARD_ERROR_OF_MEAN|4.07|<|0.001||95.0|-21.62|-5.65||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-5.65|-21.62|<0.001
71709674|NCT04003142|142936302|SUPERIORITY||LSMean difference|-18.94|STANDARD_ERROR_OF_MEAN|4.05|<|0.001||95.0|-26.89|-10.98||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-10.98|-26.89|<0.001
71709675|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|1.881||||0.02||95.0|1.11|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||3.233|1.110|0.020
71709676|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.645|||<|0.001|TWO_SIDED|95.0|1.585|4.498||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||4.498|1.585|<0.001
71709677|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001||95.0|1.535|4.001||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.001|1.535|<0.001
71709678|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.464|||<|0.001|TWO_SIDED|95.0|1.534|4.004||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.004|1.534|<0.001
71709679|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.367|||<|0.001||95.0|1.502|3.762||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.762|1.502|<0.001
71709680|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.894|||<|0.001||95.0|1.835|4.609||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||4.609|1.835|<0.001
71709681|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.902|||<|0.001|TWO_SIDED|95.0|1.829|4.657||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.657|1.829|<0.001
71709682|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|3.218|||<|0.001||95.0|2.025|5.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.172|2.025|<0.001
71709683|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.153|||<|0.001||95.0|1.375|3.394||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.394|1.375|<0.001
71709684|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|3.074|||<|0.001||95.0|1.957|4.878||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||4.878|1.957|<0.001
71709685|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.05||||0.002||95.0|1.31|3.228||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.228|1.310|0.002
71709686|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.908|||<|0.001||95.0|1.856|4.599||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.599|1.856|<0.001
71765529|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.8838||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.8838
71765530|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.4012||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||||0.4012
71709687|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.113||||0.001||95.0|1.349|3.332||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.332|1.349|0.001
71709688|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.594|||<|0.001||95.0|1.653|4.104||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.104|1.653|<0.001
71709689|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|1.891||||0.005|TWO_SIDED|95.0|1.21|2.973||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||2.973|1.210|0.005
71709690|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|3.314|||<|0.001||95.0|2.108|5.265||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.265|2.108|<0.001
71709691|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|1.646||||0.027||95.0|1.06|2.566||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||2.566|1.060|0.027
71709692|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.347|||<|0.001||95.0|1.507|3.683||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.683|1.507|<0.001
71709693|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|1.792||||0.01|TWO_SIDED|95.0|1.153|2.799||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||2.799|1.153|0.010
71709694|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.819|||<|0.001||95.0|1.805|4.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.441|1.805|<0.001
71709695|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.357|||<|0.001||95.0|1.513|3.699||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.699|1.513|<0.001
71709696|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|3.131|||<|0.001||95.0|1.999|4.95||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.950|1.999|<0.001
71709697|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|1.373||||0.152||95.0|0.891|2.122||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.122|0.891|0.152
71709698|NCT04003142|142936303|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.001||95.0|1.351|3.252||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||3.252|1.351|<0.001
71709699|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|0.915||||0.951||95.0|0.036|23.464||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||23.464|0.036|0.951
71765531|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.6131||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.6131
71765532|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.5964||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.5964
71709700|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.889||||0.362|TWO_SIDED|95.0|0.364|58.864||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||58.864|0.364|0.362
71765533|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.254||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||||0.2540
71765534|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.8524||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.8524
71765535|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.6969||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.6969
71765536|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.3108||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||||0.3108
71765537|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.8719||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.8719
71765538|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.6105||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.6105
71765539|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.0709||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||||0.0709
71765540|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.9574||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.9574
71765541|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.231||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.2310
71709701|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.775||||0.138||95.0|0.785|12.87||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||12.870|0.785|0.138
71709702|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.342||||0.704||95.0|0.291|6.914||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||6.914|0.291|0.704
71709703|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|0.798||||0.741||95.0|0.194|3.079||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.079|0.194|0.741
71709704|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.292||||0.134||95.0|0.809|7.443||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||7.443|0.809|0.134
71709705|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|3.474||||0.062||95.0|1.039|15.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||15.712|1.039|0.062
71709706|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|6.184||||0.004||95.0|2.025|26.875||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||26.875|2.025|0.004
71709707|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|4.217||||0.028|TWO_SIDED|95.0|1.305|18.806||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||18.806|1.305|0.028
71765542|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.0672||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||||0.0672
71765543|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.8441||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.8441
71709708|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|3.802||||0.044||95.0|1.157|17.075||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||17.075|1.157|0.044
71709709|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.342||||0.519||95.0|0.551|3.382||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.382|0.551|0.519
71709710|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.961||||0.117||95.0|0.863|4.741||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.741|0.863|0.117
71765544|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.6741||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.6741
71765545|NCT00797966|143033537|SUPERIORITY_OR_OTHER|||||||0.0183||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||||0.0183
71765546|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.49||||0.3007|TWO_SIDED|95.0|0.12|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.12|0.3007
71765547|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.94||||0.8812|TWO_SIDED|95.0|0.42|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||2.10|0.42|0.8812
71765548|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.32||||0.0553|TWO_SIDED|95.0|0.1|1.07||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.07|0.10|0.0553
71765549|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.78||||0.6051|TWO_SIDED|95.0|0.3|2.05||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.05|0.30|0.6051
71765550|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.92||||0.8264|TWO_SIDED|95.0|0.46|1.85||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.85|0.46|0.8264
71709711|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.471||||0.393||95.0|0.612|3.687||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.687|0.612|0.393
71709712|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.087||||0.086||95.0|0.923|5.043||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||5.043|0.923|0.086
71709713|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.774||||0.168||95.0|0.798|4.143||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.143|0.798|0.168
71709714|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.374||||0.03||95.0|1.112|5.41||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||5.410|1.112|0.030
71709715|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.605||||0.287|TWO_SIDED|95.0|0.681|3.971||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.971|0.681|0.287
71709716|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.108||||0.08||95.0|0.936|5.076||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||5.076|0.936|0.080
71826744|NCT00383188|143158060|SUPERIORITY||LSM Difference|-9.019|STANDARD_ERROR_OF_MEAN|3.849||0.0194|TWO_SIDED|95.0|-16.58|-1.463|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.463|-16.58|0.0194
71826745|NCT00383188|143158060|SUPERIORITY||LSM Difference|-5.946|STANDARD_ERROR_OF_MEAN|4.488||0.1855|TWO_SIDED|95.0|-14.76|2.863|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.863|-14.76|0.1855
71826746|NCT00383188|143158060|SUPERIORITY||LSM Difference|-5.249|STANDARD_ERROR_OF_MEAN|4.611||0.2553|TWO_SIDED|95.0|-14.3|3.803|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.803|-14.30|0.2553
71886694|NCT02475655|143293602|SUPERIORITY||Mean Difference (Net)|-4.1||||0.43|TWO_SIDED|90.0|-12.6|4.45||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 12.||4.45|-12.6|0.43
71709717|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.599||||0.247|TWO_SIDED|95.0|0.73|3.636||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||3.636|0.730|0.247
71709718|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|2.481||||0.017||95.0|1.201|5.441||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||5.441|1.201|0.017
71709719|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.728||||0.212||95.0|0.744|4.236||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.236|0.744|0.212
71709720|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|3.536||||0.002||95.0|1.666|8.207||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||8.207|1.666|0.002
71709721|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|1.701||||0.225||95.0|0.733|4.169||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.169|0.733|0.225
71709722|NCT04003142|142936304|SUPERIORITY||Odds Ratio (OR)|3.049||||0.006||95.0|1.42|7.125||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||7.125|1.420|0.006
71709723|NCT03382873|142936326|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71886695|NCT02475655|143293603|SUPERIORITY||Mean Difference (Net)|1.23||||0.74|TWO_SIDED|90.0|-5.08|7.54||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 5.||7.54|-5.08|0.74
71709724|NCT03382873|142936327|SUPERIORITY|||||||0.0001|||||||ANOVA|Intervention sequence and sex were used as independent predictors in the model.||Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.0001
71709725|NCT03382873|142936328|SUPERIORITY|||||||0.9476|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9476
71709726|NCT03382873|142936329|SUPERIORITY|||||||0.0112|||||||ANOVA|Treatment group, time and their interaction were fixed effects and participants were random effects||||||0.0112
71709727|NCT03382873|142936330|SUPERIORITY|||||||0.9085|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison of GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest).||||0.9085
71709728|NCT03382873|142936331|SUPERIORITY|||||||0.2063|||||||ANOVA|Intervention sequence and sex used as independent predictors in the model.||Comparison between the GLB/GLB intervention sequence and the GLB+/GLB+ intervention sequence (the primary comparison of interest)||||0.2063
71709729|NCT02592655|142936332|SUPERIORITY_OR_OTHER|||||||0.002||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.002
71709730|NCT02592655|142936332|SUPERIORITY_OR_OTHER|||||||0.008||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.008
71709731|NCT02592655|142936332|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."||||0.5
71826747|NCT00383188|143158060|SUPERIORITY||LSM Difference|-4.041|STANDARD_ERROR_OF_MEAN|3.912||0.302|TWO_SIDED|95.0|-11.72|3.639|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||3.639|-11.72|0.3020
71826748|NCT00383188|143158060|SUPERIORITY||LSM Difference|-10.27|STANDARD_ERROR_OF_MEAN|3.847||0.0078|TWO_SIDED|95.0|-17.82|-2.715|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.715|-17.82|0.0078
71886696|NCT02475655|143293603|SUPERIORITY||Mean Difference (Net)|3.76||||0.42|TWO_SIDED|90.0|-3.94|11.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 12.||11.5|-3.94|0.42
71709732|NCT02592655|142936332|SUPERIORITY_OR_OTHER|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 17 to accommodate for missing ultrasound data."||||0.5
71709733|NCT03996395|142936335|OTHER||Descriptive statistic|71.0|STANDARD_DEVIATION|23.0|||TWO_SIDED|||||||||||||
71709734|NCT05135754|142936369|SUPERIORITY||Risk Ratio (RR)|0.59||||0.046|TWO_SIDED|95.0|0.35|0.99|||Mixed Models Analysis|||||0.99|0.35|0.046
71709735|NCT05135754|142936370|SUPERIORITY||Mean Difference (Final Values)|6.61|||<|0.001|TWO_SIDED|95.0|3.45|9.78|||Mixed Models Analysis|||||9.78|3.45|<0.001
71709736|NCT05135754|142936371|SUPERIORITY||Mean Difference (Final Values)|20.01|||<|0.001|TWO_SIDED|95.0|15.02|25.0|||Mixed Models Analysis|||||25.00|15.02|<0.001
71709737|NCT05135754|142936372|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED|95.0|2.71|9.94|||Mixed Models Analysis|||||9.94|2.71|<0.001
71709738|NCT05135754|142936373|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|8.26|20.35|||Mixed Models Analysis|||||20.35|8.26|<0.001
71709739|NCT05135754|142936374|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.075|TWO_SIDED||||||Mixed Models Analysis|||||||0.075
71709740|NCT05135754|142936375|SUPERIORITY||Mean Difference (Final Values)|4.68||||0.004|TWO_SIDED|95.0|1.55|7.81|||Mixed Models Analysis|||||7.81|1.55|0.004
71709741|NCT02757963|142936407|OTHER||Proportion|0.883|||||TWO_SIDED|95.0|0.849|0.912|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|||0.912|0.849|
71709742|NCT02757963|142936408|OTHER||Proportion|0.877|||||TWO_SIDED|95.0|0.846|0.904|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.904|0.846|
71709743|NCT02757963|142936408|OTHER||Proportion|0.889|||||TWO_SIDED|95.0|0.854|0.917|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.917|0.854|
71709744|NCT02757963|142936408|OTHER||Proportion|0.873|||||TWO_SIDED|95.0|0.843|0.9|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.900|0.843|
71709745|NCT02757963|142936409|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.926|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.926|0.870|
71709746|NCT02757963|142936409|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.934|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.934|0.873|
71709747|NCT02757963|142936409|OTHER||Proportion|0.907|||||TWO_SIDED|95.0|0.873|0.935|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.935|0.873|
71709748|NCT02757963|142936409|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.87|0.925|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm PSS \>=8 or BPE/BPO \>=3||0.925|0.870|
71709749|NCT02757963|142936410|OTHER||Proportion|0.362|||||TWO_SIDED|95.0|0.337|0.386|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8||0.386|0.337|
71709750|NCT02757963|142936410|OTHER||Proportion|0.368|||||TWO_SIDED|95.0|0.341|0.395|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO \>=3||0.395|0.341|
71709751|NCT02757963|142936410|OTHER||Proportion|0.377|||||TWO_SIDED|95.0|0.349|0.406|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 and BPE/BPO \>=3||0.406|0.349|
71709752|NCT02757963|142936410|OTHER||Proportion|0.355|||||TWO_SIDED|95.0|0.332|0.379|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS \>=8 or BPE/BPO \>=3||0.379|0.332|
71709753|NCT02757963|142936411|OTHER||Kappa statistic|0.55|||||TWO_SIDED|95.0|0.51|0.58||||||||0.58|0.51|
71709754|NCT03109769|142936424|SUPERIORITY|||||||0.0444|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0444
71709755|NCT03109769|142936424|SUPERIORITY||Mean Difference (Net)|-0.1373||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0002
71709756|NCT03109769|142936424|SUPERIORITY||Median Difference (Final Values)|0.0932||||0.0283|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"|||||0.0283
71709757|NCT03109769|142936425|SUPERIORITY|||||||0.0283|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."||||0.0283
71709758|NCT03109769|142936425|SUPERIORITY||Mean Difference (Net)|-0.1177||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.0002
71709759|NCT03109769|142936425|SUPERIORITY||Mean Difference (Net)|0.1014||||0.4809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"|||||0.4809
71709760|NCT00761137|142936430|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||"Primary outcome was analyzed by a mixed-effects ANOVA model employing subject as a random factor as well as visit and treatment as fixed factors. Intention-to-treat (ITT) sample was analyzed. Unweighted means and their 95% Confidence Interval (CI) are reported, which represent treatment group means adjusted for the effect of visit and removing the intra-subject variability. For all analyses, significance level was set at 5%."||||0.6
71709761|NCT01197300|142936439|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|3.7||||0.8505|TWO_SIDED|95.0|-37.242|44.642||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 18||44.642|-37.242|0.8505
71709762|NCT01197300|142936439|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|21.752||||0.218|TWO_SIDED|95.0|-14.126|57.63||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 24||57.630|-14.126|0.2180
71709763|NCT01197300|142936440|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|2.36||||0.3544|TWO_SIDED|95.0|-2.886|7.606||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 18||7.606|-2.886|0.3544
71709764|NCT01197300|142936440|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|1.179||||0.705|TWO_SIDED|95.0|-5.281|7.639||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 24||7.639|-5.281|0.7050
71709765|NCT01197300|142936441|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|121.129||||0.531|TWO_SIDED|95.0|-291.0|533.258||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 18||533.258|-291.000|0.5310
71709766|NCT01197300|142936441|SUPERIORITY|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|65.674||||0.7347|TWO_SIDED|95.0|-344.067|475.415||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 24||475.415|-344.067|0.7347
71709767|NCT01197300|142936442|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-147.68||||0.4143|TWO_SIDED|95.0|-394.41|99.049||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 18||99.049|-394.410|0.4143
71709768|NCT01197300|142936442|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-132.437||||0.1266|TWO_SIDED|95.0|-286.452|21.579||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 24||21.579|-286.452|0.1266
71709769|NCT01197300|142936443|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-17.691||||0.2123|TWO_SIDED|95.0|-41.925|6.543||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 18||6.543|-41.925|0.2123
71709770|NCT01197300|142936443|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-3.662||||0.4852|TWO_SIDED|95.0|-21.479|14.155||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 24||14.155|-21.479|0.4852
71765551|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.869|TWO_SIDED|95.0|0.54|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.10|0.54|0.8690
71709771|NCT01197300|142936444|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-4.661||||0.9009|TWO_SIDED|95.0|-16.647|7.325||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 18||7.325|-16.647|0.9009
71709772|NCT01197300|142936444|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-2.558||||0.9472|TWO_SIDED|95.0|-8.864|3.747||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 24||3.747|-8.864|0.9472
71709773|NCT01197300|142936445|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-1.482||||0.46|TWO_SIDED|95.0|-3.805|0.841||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 18||0.841|-3.805|0.4600
71765552|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.35||||0.3441|TWO_SIDED|95.0|0.74|2.44||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.44|0.74|0.3441
71765553|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.14||||0.6375|TWO_SIDED|95.0|0.67|1.94||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.94|0.67|0.6375
71765554|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.31||||0.3135|TWO_SIDED|95.0|0.78|2.21||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.21|0.78|0.3135
71765555|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.35||||0.0035|TWO_SIDED|95.0|1.32|4.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||4.18|1.32|0.0035
71765556|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.4358|TWO_SIDED|95.0|0.7|2.31||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||2.31|0.70|0.4358
71709774|NCT01197300|142936445|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.41||||0.9236|TWO_SIDED|95.0|-2.423|1.603||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 24||1.603|-2.423|0.9236
71765557|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|2.02||||0.0063|TWO_SIDED|95.0|1.2|3.41||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.41|1.20|0.0063
71765558|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.3968|TWO_SIDED|95.0|0.72|2.23||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.23|0.72|0.3968
71765559|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.27||||0.299|TWO_SIDED|95.0|0.81|2.0||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.00|0.81|0.2990
71886697|NCT02475655|143293604|SUPERIORITY||Mean Difference (Net)|-0.63||||0.66|TWO_SIDED|90.0|-2.99|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 5.||1.73|-2.99|0.66
71709775|NCT01197300|142936446|OTHER|The number and percentage of patients with new vertebral fractures during the 12 month Extension period was presented by Core treatment group. Between-treatment differences were evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New vertebral fractures at Month 12 Extension||||1.0000
71709776|NCT01197300|142936447|OTHER|The number and percentage of patients with new morphometric vertebral fractures during the 12 month extension period was presented by core treatment group. Between-treatment differences will be evaluated using Fisher's exact test.||||||1|||||||Fisher Exact|||New morphometric vertebral fractures at Month 12 Extension||||1.0000
71765560|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.39||||0.1614|TWO_SIDED|95.0|0.86|2.25||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.25|0.86|0.1614
71765561|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.29||||0.3254|TWO_SIDED|95.0|0.79|2.12||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.12|0.79|0.3254
71765562|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.02||||0.9463|TWO_SIDED|95.0|0.64|1.62||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.62|0.64|0.9463
71709777|NCT01197300|142936448|OTHER||Odds Ratio (OR)|4.73||||0.3971|TWO_SIDED|95.0|0.13|173.07||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 15||173.07|0.13|0.3971
71709778|NCT01197300|142936448|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 18||999.99|0.01|0.6046
71709779|NCT01197300|142936448|OTHER||Odds Ratio (OR)|0.01||||0.6046|TWO_SIDED|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 21||999.99|0.01|0.6046
71709780|NCT01197300|142936448|OTHER||Odds Ratio (OR)|1.31||||0.875|TWO_SIDED|95.0|0.05|38.04||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 24||38.04|0.05|0.8750
71709781|NCT01197300|142936449|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.01||||0.9231|TWO_SIDED|95.0|-0.18|0.17||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL1 at Month 24||0.17|-0.18|0.9231
71709782|NCT01197300|142936449|OTHER|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.11||||0.2694|TWO_SIDED|95.0|-0.32|0.1||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Extension baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL2 at Month 24||0.10|-0.32|0.2694
71709783|NCT00834574|142936458|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.2|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|97.2|
71709784|NCT00834574|142936459|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
71709785|NCT00834574|142936460|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|101|
71709786|NCT00530257|142936509|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of \<=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen's d= \>0.655)|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.01
71709787|NCT00530257|142936510|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch Walk, Don't Walk||||<0.01
71709788|NCT00530257|142936511|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||This p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.||||<0.05
71709789|NCT00530257|142936513|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||We did not correct for multiple comparisons|t-test, 2 sided|We used a paired t-test||A paired t-test was used to compare the medication versus placebo.||||<0.05
71709790|NCT00530257|142936515|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk.|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71709791|NCT00530257|142936516|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The p value adjusts for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||<0.01
71709792|NCT00530257|142936517|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71709793|NCT00530257|142936518|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71709794|NCT00530257|142936519|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71709795|NCT00530257|142936520|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk||||<0.01
71709796|NCT02410200|142936521|SUPERIORITY_OR_OTHER|||||||0.009|||||||Wilcoxon Signed Rank test|||||||0.0090
71709797|NCT01879826|142936570|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance||||||0.044|||||||t-test, 2 sided|||||||0.044
71709798|NCT01879826|142936571|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance.||||||0.04|||||||t-test, 2 sided|||||||0.04
71826749|NCT00383188|143158060|SUPERIORITY||LSM Difference|-8.522|STANDARD_ERROR_OF_MEAN|4.486||0.0578|TWO_SIDED|95.0|-17.33|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.284|-17.33|0.0578
71826750|NCT00383188|143158060|SUPERIORITY||LSM Difference|-7.042|STANDARD_ERROR_OF_MEAN|4.61||0.127|TWO_SIDED|95.0|-16.09|2.007|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.007|-16.09|0.1270
71826751|NCT00383188|143158060|SUPERIORITY||LSM Difference|5.927|STANDARD_ERROR_OF_MEAN|4.051||0.1438|TWO_SIDED|95.0|-2.023|13.877|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||13.877|-2.023|0.1438
71886698|NCT02475655|143293604|SUPERIORITY||Mean Difference (Net)|-1.56||||0.27|TWO_SIDED|90.0|-3.93|0.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 12.||0.80|-3.93|0.27
71765563|NCT00797966|143033538|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.74||||0.008|TWO_SIDED|95.0|1.14|2.65||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.65|1.14|0.0080
71765564|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.59||||0.5791|TWO_SIDED|95.0|0.09|3.9||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||3.90|0.09|0.5791
71765565|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.43||||0.2653|TWO_SIDED|95.0|0.1|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.93|0.10|0.2653
71765566|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.39||||0.2259|TWO_SIDED|95.0|0.08|1.87||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.87|0.08|0.2259
71765567|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.83||||0.6986|TWO_SIDED|95.0|0.32|2.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.18|0.32|0.6986
71765568|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.61||||0.2339|TWO_SIDED|95.0|0.28|1.35||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.35|0.28|0.2339
71765569|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.07||||0.8615|TWO_SIDED|95.0|0.53|2.15||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||2.15|0.53|0.8615
71765570|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.06||||0.8807|TWO_SIDED|95.0|0.51|2.2||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.20|0.51|0.8807
71765571|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9035|TWO_SIDED|95.0|0.52|1.77||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.77|0.52|0.9035
71765572|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.19||||0.5898|TWO_SIDED|95.0|0.64|2.24|||Cochran-Mantel-Haenszel|||Week 11 values presented here.||2.24|0.64|0.5898
71765573|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.82||||0.084|TWO_SIDED|95.0|0.93|3.58||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.58|0.93|0.0840
71765574|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.96||||0.9115|TWO_SIDED|95.0|0.49|1.88||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.88|0.49|0.9115
71765575|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.77||||0.0522|TWO_SIDED|95.0|0.98|3.17||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||3.17|0.98|0.0522
71765576|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.24||||0.4997|TWO_SIDED|95.0|0.65|2.34||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||2.34|0.65|0.4997
71765577|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.16||||0.5846|TWO_SIDED|95.0|0.69|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.93|0.69|0.5846
71765578|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|0.99||||0.9602|TWO_SIDED|95.0|0.55|1.76||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.76|0.55|0.9602
71765579|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.62||||0.1254|TWO_SIDED|95.0|0.87|3.02||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||3.02|0.87|0.1254
71826752|NCT00383188|143158060|SUPERIORITY||LSM Difference|-1.979|STANDARD_ERROR_OF_MEAN|3.931||0.6149|TWO_SIDED|95.0|-9.696|5.738|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.738|-9.696|0.6149
71826753|NCT00383188|143158060|SUPERIORITY||LSM Difference|6.545|STANDARD_ERROR_OF_MEAN|4.664||0.1609|TWO_SIDED|95.0|-2.61|15.7|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.700|-2.610|0.1609
71709799|NCT00839930|142936576|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.39||||||90.0|87.33|99.86|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.86|87.33|
71709800|NCT00839930|142936577|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.14||||||90.0|91.04|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.52|91.04|
71709801|NCT00839930|142936578|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.64||||||90.0|92.13|101.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||101.37|92.13|
71709802|NCT02500836|142936579|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
71709803|NCT02500836|142936580|SUPERIORITY||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||<0.0001
71709804|NCT02003898|142936588|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|-0.03|0.098||||||||0.098|-0.03|
71709805|NCT04250207|142936643|SUPERIORITY|||||||0.0065|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0065
71709806|NCT04250207|142936643|SUPERIORITY|||||||0.0344|||||||Other (Wilcoxon Rank Sum Test)|||||||0.0344
71709807|NCT04250207|142936644|SUPERIORITY|||||||0.3587|||||||Wilcoxon Rank Sum Test|||Baseline||||0.3587
71709808|NCT04250207|142936644|SUPERIORITY|||||||0.5724|||||||Wilcoxon Rank Sum Test|||Baseline||||0.5724
71709809|NCT04250207|142936644|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3703
71709810|NCT04250207|142936644|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 1||||> 0.9999
71709811|NCT04250207|142936644|SUPERIORITY|||||||0.3703|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3703
71709812|NCT04250207|142936644|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
71709813|NCT04250207|142936644|SUPERIORITY|||||||0.0257|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0257
71709814|NCT04250207|142936644|SUPERIORITY|||||||0.7263|||||||Wilcoxon Rank Sum Test|||||||0.7263
71709815|NCT04250207|142936644|SUPERIORITY|||||||0.0607|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0607
71709816|NCT04250207|142936644|SUPERIORITY|||||||0.046|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0460
71709817|NCT04250207|142936644|SUPERIORITY|||||||0.0111|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0111
71709818|NCT04250207|142936644|SUPERIORITY|||||||0.0011|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0011
71709819|NCT04250207|142936644|SUPERIORITY|||||||0.02|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0200
71709820|NCT04250207|142936644|SUPERIORITY|||||||0.0476|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0476
71709821|NCT04250207|142936644|SUPERIORITY|||||||0.0065|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0065
71709822|NCT04250207|142936644|SUPERIORITY|||||||0.0344|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0344
71709823|NCT04250207|142936644|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0250
71709824|NCT04250207|142936644|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0733
71709825|NCT04250207|142936644|SUPERIORITY|||||||0.0072|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0072
71709826|NCT04250207|142936644|SUPERIORITY|||||||0.1124|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1124
71709827|NCT04250207|142936644|SUPERIORITY|||||||0.0199|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0199
71709828|NCT04250207|142936644|SUPERIORITY|||||||0.2331|||||||Wilcoxon Rank Sum Test|||Week 24||||0.2331
71709829|NCT04250207|142936644|SUPERIORITY|||||||0.0024|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0024
71709830|NCT04250207|142936644|SUPERIORITY|||||||0.1672|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1672
71709831|NCT04250207|142936644|SUPERIORITY|||||||0.0047|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0047
71709832|NCT04250207|142936644|SUPERIORITY|||||||0.0625|||||||Wilcoxon Rank Sum Test|||Week 52||||0.0625
71709833|NCT04250207|142936645|SUPERIORITY|||||||0.2434|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2434
71709834|NCT04250207|142936645|SUPERIORITY|||||||0.2126|||||||Wilcoxon Rank Sum Test|||Week 1||||0.2126
71709835|NCT04250207|142936645|SUPERIORITY|||||||0.079|||||||Wilcoxon Rank Sum Test|||Week 2||||0.0790
71709836|NCT04250207|142936645|SUPERIORITY|||||||0.3043|||||||Wilcoxon Rank Sum Test|||Week 2||||0.3043
71709837|NCT04250207|142936645|SUPERIORITY|||||||0.0357|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0357
71709838|NCT04250207|142936645|SUPERIORITY|||||||0.0803|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0803
71709839|NCT04250207|142936645|SUPERIORITY|||||||0.015|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0150
71709840|NCT04250207|142936645|SUPERIORITY|||||||0.0012|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0012
71709841|NCT04250207|142936645|SUPERIORITY|||||||0.0314|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0314
71709842|NCT04250207|142936645|SUPERIORITY|||||||0.0019|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0019
71709843|NCT04250207|142936645|SUPERIORITY|||||||0.017|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0170
71709844|NCT04250207|142936645|SUPERIORITY|||||||0.0021|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0021
71709845|NCT04250207|142936645|SUPERIORITY|||||||0.0127|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0127
71709846|NCT04250207|142936645|SUPERIORITY|||||||0.0014|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0014
71709847|NCT04250207|142936645|SUPERIORITY|||||||0.0677|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0677
71709848|NCT04250207|142936645|SUPERIORITY|||||||0.0243|||||||Wilcoxon Rank Sum Test|||Week 16||||0.0243
71709849|NCT04250207|142936645|SUPERIORITY|||||||0.1867|||||||Wilcoxon Rank Sum Test|||Week 20||||0.1867
71709850|NCT04250207|142936645|SUPERIORITY|||||||0.025|||||||Wilcoxon Rank Sum Test|||Week 20||||0.0250
71709851|NCT04250207|142936645|SUPERIORITY|||||||0.3213|||||||Wilcoxon Rank Sum Test|||Week 24||||0.3213
71709852|NCT04250207|142936645|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank Sum Test|||Week 24||||0.0298
71709853|NCT04250207|142936645|SUPERIORITY|||||||0.1449|||||||Wilcoxon Rank Sum Test|||Week 38||||0.1449
71709854|NCT04250207|142936645|SUPERIORITY|||||||0.0947|||||||Wilcoxon Rank Sum Test|||Week 38||||0.0947
71709855|NCT04250207|142936645|SUPERIORITY|||||||0.5181|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5181
71709856|NCT04250207|142936645|SUPERIORITY|||||||0.1898|||||||Wilcoxon Rank Sum Test|||Week 52||||0.1898
71765580|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.13||||0.667|TWO_SIDED|95.0|0.65|1.99||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.99|0.65|0.6670
71709857|NCT04250207|142936646|SUPERIORITY|||||||0.0021|||||||Log Rank|||||||0.0021
71709858|NCT04250207|142936646|SUPERIORITY|||||||0.1696|||||||Log Rank|||||||0.1696
71709859|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4872|||||||Chi-square or Fisher exact|||Week 5||||0.4872
71709860|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4634|||||||Chi-square or Fisher exact|||Week 5||||0.4634
71709861|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.605|||||||Chi-square or Fisher exact|||Week 7||||0.6050
71709862|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4762|||||||Chi-square or Fisher exact|||Week 7||||0.4762
71765581|NCT00797966|143033539|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.7||||0.0525|TWO_SIDED|95.0|0.98|2.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||2.93|0.98|0.0525
71765582|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.98||||0.9462|TWO_SIDED|95.0|0.52|1.84||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.84|0.52|0.9462
71765583|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.8||||0.4971|TWO_SIDED|95.0|0.43|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.49|0.43|0.4971
71765584|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.93||||0.8118|TWO_SIDED|95.0|0.53|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.||1.63|0.53|0.8118
71765585|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.95||||0.8323|TWO_SIDED|95.0|0.59|1.53||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.53|0.59|0.8323
71765586|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.68||||0.093|TWO_SIDED|95.0|0.43|1.08||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.08|0.43|0.0930
71765587|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.88||||0.553|TWO_SIDED|95.0|0.59|1.32||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.||1.32|0.59|0.5530
71765588|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.8007|TWO_SIDED|95.0|0.69|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.61|0.69|0.8007
71765589|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.03||||0.8945|TWO_SIDED|95.0|0.71|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.49|0.71|0.8945
71765590|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.17||||0.3837|TWO_SIDED|95.0|0.83|1.64||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.||1.64|0.83|0.3837
71709863|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
71709864|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 9||||> 0.9999
71709865|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4227|||||||Chi-square or Fisher exact|||Week 12||||0.4227
71709866|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6796|||||||Chi-square or Fisher exact|||Week 12||||0.6796
71709867|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4642|||||||Chi-square or Fisher exact|||Week 16||||0.4642
71709868|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4645|||||||Chi-square or Fisher exact|||Week 16||||0.4645
71709869|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2744|||||||Chi-square or Fisher exact|||Week 20||||0.2744
71709870|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7026|||||||Chi-square or Fisher exact|||Week 20||||0.7026
71709871|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.7817|||||||Chi-square or Fisher exact|||Week 24||||0.7817
71709872|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.9285|||||||Chi-square or Fisher exact|||Week 24||||0.9285
71709873|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 38||||0.0135
71709874|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.6992|||||||Chi-square or Fisher exact|||Week 38||||0.6992
71709875|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0135|||||||Chi-square or Fisher exact|||Week 52||||0.0135
71709876|NCT04250207|142936647|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5154|||||||Chi-square or Fisher exact|||Week 52||||0.5154
71709877|NCT04250207|142936648|SUPERIORITY|||||||0.1209|||||||Log Rank|||||||0.1209
71709878|NCT04250207|142936648|SUPERIORITY|||||||0.7116|||||||Log Rank|||||||0.7116
71709879|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0915|||||||Chi-square or Fisher exact|||Week 3||||0.0915
71709880|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3282|||||||Chi-square or Fisher exact|||Week 3||||0.3282
71709881|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0648|||||||Chi-square or Fisher exact|||Week 5||||0.0648
71709882|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.031|||||||Chi-square or Fisher exact|||Week 5||||0.0310
71709883|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0187|||||||Chi-square or Fisher exact|||Week 7||||0.0187
71709884|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0036|||||||Chi-square or Fisher exact|||Week 7||||0.0036
71709885|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0687|||||||Chi-square or Fisher exact|||Week 9||||0.0687
71709886|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0016|||||||Chi-square or Fisher exact|||Week 9||||0.0016
71709887|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0218|||||||Chi-square or Fisher exact|||Week 12||||0.0218
71709888|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0013|||||||Chi-square or Fisher exact|||Week 12||||0.0013
71709889|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0348|||||||Chi-square or Fisher exact|||Week 16||||0.0348
71709890|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1028|||||||Chi-square or Fisher exact|||Week 16||||0.1028
71709891|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.8677|||||||Chi-square or Fisher exact|||Week 20||||0.8677
71765591|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.7064|TWO_SIDED|95.0|0.72|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.63|0.72|0.7064
71826754|NCT00383188|143158060|SUPERIORITY||LSM Difference|6.579|STANDARD_ERROR_OF_MEAN|4.78||0.1691|TWO_SIDED|95.0|-2.804|15.961|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Patient's Global Assessment of Arthritis count as the covariate and participant as a random effect.||15.961|-2.804|0.1691
71655430|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.8252|||TWO_SIDED|95.0|-5.0|2.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-5.0|
71709892|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.4401|||||||Chi-square or Fisher exact|||Week 20||||0.4401
71655431|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.65|STANDARD_ERROR_OF_MEAN|1.8254|||TWO_SIDED|95.0|-6.2|0.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-6.2|
71655432|NCT02037165|142829267|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.8257|||TWO_SIDED|95.0|-3.9|3.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.3|-3.9|
71655433|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.8|
71655434|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|2.18|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-0.5|4.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.9|-0.5|
71709893|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.5926|||||||Chi-square or Fisher exact|||Week 24||||0.5926
71709894|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0732|||||||Chi-square or Fisher exact|||Week 24||||0.0732
71709895|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2497|||||||Chi-square or Fisher exact|||Week 38||||0.2497
71765592|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.06||||0.7469|TWO_SIDED|95.0|0.74|1.52||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.52|0.74|0.7469
71709896|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.2453|||||||Chi-square or Fisher exact|||Week 38||||0.2453
71709897|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
71709898|NCT04250207|142936649|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
71826755|NCT00383188|143158061|SUPERIORITY||LSM Difference|-1.409|STANDARD_ERROR_OF_MEAN|3.341||0.6733|TWO_SIDED|95.0|-7.967|5.149|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.149|-7.967|0.6733
71709899|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0093|||||||Chi-square or Fisher exact|||Week 3||||0.0093
71765593|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.34||||0.0832|TWO_SIDED|95.0|0.97|1.86||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.||1.86|0.97|0.0832
71765594|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.09||||0.6611|TWO_SIDED|95.0|0.74|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.61|0.74|0.6611
71765595|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.13||||0.4435|TWO_SIDED|95.0|0.83|1.56||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.56|0.83|0.4435
71765596|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0118|TWO_SIDED|95.0|1.09|1.98||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.||1.98|1.09|0.0118
71709900|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 3||||> 0.9999
71709901|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0006|||||||Chi-square or Fisher exact|||Week 5||||0.0006
71709902|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3449|||||||Chi-square or Fisher exact|||Week 5||||0.3449
71765597|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.89||||0.5111|TWO_SIDED|95.0|0.63|1.26||Cochran-Mantel-Haenszel general association test controlling for study center.|Chi-squared, Corrected|||Week 14 values presented here.||1.26|0.63|0.5111
71709903|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
71709904|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 7||||0.0028
71709905|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0001|||||||Chi-square or Fisher exact|||Week 9||||0.0001
71709906|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 9||||0.0028
71765598|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|0.9||||0.4903|TWO_SIDED|95.0|0.66|1.22||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.22|0.66|0.4903
71765599|NCT00797966|143033540|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.28||||0.0662|TWO_SIDED|95.0|0.98|1.67||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.||1.67|0.98|0.0662
71826756|NCT00383188|143158061|SUPERIORITY||LSM Difference|-5.629|STANDARD_ERROR_OF_MEAN|3.274||0.0859|TWO_SIDED|95.0|-12.05|0.797|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||0.797|-12.05|0.0859
71826757|NCT00383188|143158061|SUPERIORITY||LSM Difference|-9.718|STANDARD_ERROR_OF_MEAN|3.8||0.0107|TWO_SIDED|95.0|-17.18|-2.259|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.259|-17.18|0.0107
71826758|NCT00383188|143158061|SUPERIORITY||LSM Difference|-3.695|STANDARD_ERROR_OF_MEAN|3.921||0.3463|TWO_SIDED|95.0|-11.39|4.002|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.002|-11.39|0.3463
71826759|NCT00383188|143158061|SUPERIORITY||LSM Difference|-5.185|STANDARD_ERROR_OF_MEAN|3.312||0.1178|TWO_SIDED|95.0|-11.69|1.316|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||1.316|-11.69|0.1178
71826760|NCT00383188|143158061|SUPERIORITY||LSM Difference|-7.107|STANDARD_ERROR_OF_MEAN|3.245||0.0288|TWO_SIDED|95.0|-13.48|-0.737|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.737|-13.48|0.0288
71709907|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 12||||< 0.0001
71709908|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0028|||||||Chi-square or Fisher exact|||Week 12||||0.0028
71709909|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||<|0.0001|||||||Chi-square or Fisher exact|||Week 16||||< 0.0001
71709910|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0011|||||||Chi-square or Fisher exact|||Week 16||||0.0011
71709911|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0094|||||||Chi-square or Fisher exact|||Week 20||||0.0094
71709912|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1281|||||||Chi-square or Fisher exact|||Week 20||||0.1281
71709913|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0051|||||||Chi-square or Fisher exact|||Week 24||||0.0051
71709914|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1313|||||||Chi-square or Fisher exact|||Week 24||||0.1313
71709915|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.0268|||||||Chi-square or Fisher exact|||Week 38||||0.0268
71709916|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.3652|||||||Chi-square or Fisher exact|||Week 38||||0.3652
71709917|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.||||||0.1854|||||||Chi-square or Fisher exact|||Week 52||||0.1854
71709918|NCT04250207|142936650|SUPERIORITY|p-value is based on the Pearson Chi-square test. When the number of responders (Achieved or Not Achieved) is less than 5 in either group, Fisher's exact test is used instead. If Fisher's exact test is used, the unconditional CI for the difference in response rates is provided.|||||>|0.9999|||||||Chi-square or Fisher exact|||Week 52||||> 0.9999
71709919|NCT04250207|142936651|SUPERIORITY|||||||0.0259|||||||Wilcoxon Rank Sum Test|||||||0.0259
71709920|NCT04250207|142936651|SUPERIORITY|||||||0.0068|||||||Wilcoxon Rank Sum Test|||||||0.0068
71709921|NCT04250207|142936652|SUPERIORITY|||||||0.4435|||||||Wilcoxon Rank Sum Test|||Week 1||||0.4435
71709922|NCT04250207|142936652|SUPERIORITY|||||||0.3402|||||||Wilcoxon Rank Sum Test|||Week 1||||0.3402
71709923|NCT04250207|142936652|SUPERIORITY||||||>|0.9999|||||||Wilcoxon Rank Sum Test|||Week 2||||> 0.9999
71709924|NCT04250207|142936652|SUPERIORITY|||||||0.0655|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0655
71709925|NCT04250207|142936652|SUPERIORITY|||||||0.0903|||||||Wilcoxon Rank Sum Test|||Week 3||||0.0903
71709926|NCT04250207|142936652|SUPERIORITY|||||||0.0216|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0216
71709927|NCT04250207|142936652|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||Week 5||||0.0020
71826761|NCT00383188|143158061|SUPERIORITY||LSM Difference|-9.743|STANDARD_ERROR_OF_MEAN|3.772||0.01|TWO_SIDED|95.0|-17.15|-2.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.340|-17.15|0.0100
71826762|NCT00383188|143158061|SUPERIORITY||LSM Difference|-5.468|STANDARD_ERROR_OF_MEAN|3.888||0.16|TWO_SIDED|95.0|-13.1|2.164|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.164|-13.10|0.1600
71709928|NCT04250207|142936652|SUPERIORITY|||||||0.0676|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0676
71709929|NCT04250207|142936652|SUPERIORITY|||||||0.0029|||||||Wilcoxon Rank Sum Test|||Week 7||||0.0029
71709930|NCT04250207|142936652|SUPERIORITY|||||||0.0335|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0335
71709931|NCT04250207|142936652|SUPERIORITY|||||||0.0053|||||||Wilcoxon Rank Sum Test|||Week 9||||0.0053
71709932|NCT04250207|142936652|SUPERIORITY|||||||0.0608|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0608
71709933|NCT04250207|142936652|SUPERIORITY|||||||0.0071|||||||Wilcoxon Rank Sum Test|||Week 12||||0.0071
71709934|NCT04250207|142936652|SUPERIORITY|||||||0.4406|||||||Wilcoxon Rank Sum Test|||Week 16||||0.4406
71709935|NCT04250207|142936652|SUPERIORITY|||||||0.1716|||||||Wilcoxon Rank Sum Test|||Week 16||||0.1716
71709936|NCT04250207|142936652|SUPERIORITY|||||||0.9856|||||||Wilcoxon Rank Sum Test|||Week 20||||0.9856
71709937|NCT04250207|142936652|SUPERIORITY|||||||0.2229|||||||Wilcoxon Rank Sum Test|||Week 20||||0.2229
71709938|NCT04250207|142936652|SUPERIORITY|||||||0.8817|||||||Wilcoxon Rank Sum Test|||Week 24||||0.8817
71709939|NCT04250207|142936652|SUPERIORITY|||||||0.2081|||||||Wilcoxon Rank Sum Test|||||||0.2081
71709940|NCT04250207|142936652|SUPERIORITY|||||||0.7335|||||||Wilcoxon Rank Sum Test|||Week 38||||0.7335
71709941|NCT04250207|142936652|SUPERIORITY|||||||0.5367|||||||Wilcoxon Rank Sum Test|||Week 38||||0.5367
71709942|NCT04250207|142936652|SUPERIORITY|||||||0.555|||||||Wilcoxon Rank Sum Test|||Week 52||||0.5550
71709943|NCT04250207|142936652|SUPERIORITY|||||||0.8718|||||||Wilcoxon Rank Sum Test|||Week 52||||0.8718
71709944|NCT03654326|142936655|SUPERIORITY||Difference in Least Squares Mean|-0.5||||0.066|TWO_SIDED|95.0|-1.01|0.03||Based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|ANCOVA|||||0.03|-1.01|0.066
71709945|NCT03654326|142936656|OTHER|Difference in percentage of participants who experienced one or more adverse events|Difference in % vs Placebo|17.7|||||TWO_SIDED|95.0|3.4|31.3|||||Based on Miettinen \& Nurminen method|||31.3|3.4|
71709946|NCT03654326|142936657|OTHER|Difference in percentage of participants who discontinued study drug due to an adverse event|Difference in % vs Placebo|3.2|||||TWO_SIDED|95.0|-0.9|9.0|||||Based on Miettinen \& Nurminen method|||9.0|-0.9|
71709947|NCT03654326|142936658|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.6|||||TWO_SIDED|95.0|-1.18|-0.06||||||||-0.06|-1.18|
71709948|NCT03654326|142936659|OTHER|The difference in least squares mean was based on the longitudinal analysis of covariance (ANCOVA) model including factors for average pelvic pain scores at baseline cycle, stratum, treatment, cycle, interaction of stratum-by-cycle, and the interaction of treatment-by-cycle as covariates|Difference in Least Squares Mean|-0.5|||||TWO_SIDED|95.0|-1.04|0.03||||||||0.03|-1.04|
71709949|NCT00835549|142936660|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|94.8|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|94.8|
71709950|NCT00835549|142936661|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.5|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.5|
71709951|NCT00835549|142936662|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105|98.7|
71709952|NCT05524948|142936694|OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.206|<|0.0001|TWO_SIDED|95.0|-1.71|-0.9|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.90|-1.71|<0.0001
71709953|NCT05524948|142936695|OTHER||Adjusted Mean Difference|-569.64|STANDARD_ERROR_OF_MEAN|97.479|<|0.0001|TWO_SIDED|95.0|-763.11|-376.17|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-376.17|-763.11|<0.0001
71709954|NCT05524948|142936696|OTHER||Adjusted Mean Difference|-418.86|STANDARD_ERROR_OF_MEAN|64.848|<|0.0001|TWO_SIDED|95.0|-547.56|-290.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-290.15|-547.56|<0.0001
71709955|NCT05524948|142936696|OTHER||Adjusted Mean Difference|-108.9|STANDARD_ERROR_OF_MEAN|32.626||0.0012|TWO_SIDED|95.0|-173.66|-44.15|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-44.15|-173.66|0.0012
71826763|NCT00383188|143158061|SUPERIORITY||LSM Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.312||0.904|TWO_SIDED|95.0|-6.9|6.101|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.101|-6.900|0.9040
71709956|NCT05524948|142936696|OTHER||Adjusted Mean Difference|-26.17|STANDARD_ERROR_OF_MEAN|22.909||0.2561|TWO_SIDED|95.0|-71.64|19.29|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||19.29|-71.64|0.2561
71709957|NCT05524948|142936697|OTHER||Adjusted Mean Difference|-721.58|STANDARD_ERROR_OF_MEAN|94.584|<|0.0001|TWO_SIDED|95.0|-909.31|-533.86|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-533.86|-909.31|<0.0001
71709958|NCT05524948|142936698|OTHER||Adjusted Mean Difference|-567.89|STANDARD_ERROR_OF_MEAN|68.09|<|0.0001|TWO_SIDED|95.0|-703.03|-432.75|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-432.75|-703.03|<0.0001
71709959|NCT05524948|142936698|OTHER||Adjusted Mean Difference|-105.39|STANDARD_ERROR_OF_MEAN|24.57|<|0.0001|TWO_SIDED|95.0|-154.15|-56.62|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-56.62|-154.15|<0.0001
71709960|NCT05524948|142936698|OTHER||Adjusted Mean Difference|-38.04|STANDARD_ERROR_OF_MEAN|26.201||0.1498|TWO_SIDED|95.0|-90.04|13.97|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||13.97|-90.04|0.1498
71765600|NCT03859973|143033544|OTHER||Mean Difference (Net)|-0.866||||0.3101|TWO_SIDED|95.0|-2.605|0.833|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.833|-2.605|0.3101
71765601|NCT03859973|143033545|OTHER||Mean Difference (Net)|-1.051||||0.2309|TWO_SIDED|95.0|-2.778|0.676|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value.||0.676|-2.778|0.2309
71765602|NCT03859973|143033546|OTHER||Mean Difference (Net)|0.577||||0.5237|TWO_SIDED|95.0|-1.207|2.362|||ANCOVA||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.||2.362|-1.207|0.5237
71709961|NCT05524948|142936699|OTHER||Adjusted Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.204|<|0.0001|TWO_SIDED|95.0|-2.58|-1.77|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-1.77|-2.58|<0.0001
71709962|NCT05524948|142936700|OTHER||Adjusted Mean Difference|-396.96|STANDARD_ERROR_OF_MEAN|95.541|<|0.0001|TWO_SIDED|95.0|-586.51|-207.41|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-207.41|-586.51|<0.0001
71709963|NCT05524948|142936701|OTHER||Adjusted Mean Difference|-341.37|STANDARD_ERROR_OF_MEAN|72.446|<|0.0001|TWO_SIDED|95.0|-485.1|-197.64|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-197.64|-485.10|<0.0001
71709964|NCT05524948|142936701|OTHER||Adjusted Mean Difference|-74.15|STANDARD_ERROR_OF_MEAN|20.905||0.0006|TWO_SIDED|95.0|-115.62|-32.68|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||-32.68|-115.62|0.0006
71709965|NCT05524948|142936701|OTHER||Adjusted Mean Difference|27.98|STANDARD_ERROR_OF_MEAN|25.942||0.2834|TWO_SIDED|95.0|-23.49|79.45|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||79.45|-23.49|0.2834
71765603|NCT03859973|143033547|OTHER||Mean Difference (Net)|-0.669||||0.642|TWO_SIDED|95.0|-3.51|2.172|||Mixed Models Analysis||Least Square Mean of (BI 425809 10 mg + Computerized Cognitive Training) - Least Square Mean of (Placebo + Computerized Cognitive Training)|Restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group.||2.172|-3.510|0.6420
71765604|NCT01478048|143033565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.0923|TWO_SIDED|95.0|0.49|1.06||Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization|Log Rank|Adjusted alpha level= 0.30||||1.06|0.49|0.0923
71709966|NCT05524948|142936702|OTHER||Adjusted Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-1.83|-1.28|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as the experimental dentifrice minus the reference dentifrice.|||-1.28|-1.83|<0.0001
71709967|NCT05524948|142936703|OTHER||Adjusted Mean Difference|-322.75|STANDARD_ERROR_OF_MEAN|67.778|<|0.0001|TWO_SIDED|95.0|-457.27|-188.23|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.||||-188.23|-457.27|<0.0001
71709968|NCT05524948|142936704|OTHER||Adjusted Mean Difference|-250.33|STANDARD_ERROR_OF_MEAN|42.838|<|0.0001|TWO_SIDED|95.0|-335.35|-165.3|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Hydrogen Sulfide|||-165.30|-335.35|<0.0001
71709969|NCT05524948|142936704|OTHER||Adjusted Mean Difference|-45.53|STANDARD_ERROR_OF_MEAN|23.439||0.055|TWO_SIDED|95.0|-92.05|0.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Methanethiol|||0.99|-92.05|0.0550
71709970|NCT05524948|142936704|OTHER||Adjusted Mean Difference|-32.68|STANDARD_ERROR_OF_MEAN|26.036||0.2124|TWO_SIDED|95.0|-84.36|18.99|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and baseline concentration as a covariate.|For Dimethyl Sulfide|||18.99|-84.36|0.2124
71709971|NCT05524948|142936705|OTHER||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|-1.52|-0.87|||ANCOVA|Analysis was performed using ANCOVA model with study product and gender as a factor and Baseline overall breath organoleptic score as a covariate.|Adjusted mean difference was calculated as experimental dentifrice minus reference dentifrice.|||-0.87|-1.52|<0.0001
71709972|NCT05155085|142936706|SUPERIORITY||Risk Difference (RD)|5.1||||0.4662|TWO_SIDED|95.0|-9.8|19.8|||Cochran-Mantel-Haenszel|||||19.8|-9.8|0.4662
71709973|NCT05155085|142936707|SUPERIORITY||LSM Difference from Placebo|-9.7|STANDARD_ERROR_OF_MEAN|11.4||0.3968|TWO_SIDED|95.0|-32.2|12.9|||Mixed Models Analysis|||||12.9|-32.2|0.3968
71709974|NCT05155085|142936708|SUPERIORITY||Risk Difference (RD)|3.3||||0.7625|TWO_SIDED|95.0|-15.2|21.6|||Fisher Exact|||||21.6|-15.2|0.7625
71709975|NCT00855166|142936735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3885|<|0.0001|TWO_SIDED|95.0|-2.84|-1.31||Significant at alpha=0.05 (2-sided)|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.31|-2.84|<0.0001
71765605|NCT01478048|143033568|SUPERIORITY_OR_OTHER||Difference using Chan-Zhang method|2.3|||||TWO_SIDED|95.0|-13.2|17.8||||||||17.8|-13.2|
71765606|NCT00955201|143033580|SUPERIORITY|||||||0.49||||||Tukey's multiple comparisons test|ANOVA|Comparison to baseline values||Evaluated within group across time||||0.49
71886699|NCT02475655|143293605|SUPERIORITY||Mean Difference (Net)|-7.1||||0.013|TWO_SIDED|90.0|-11.7|-2.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 5.||-2.46|-11.7|0.013
71709976|NCT00855166|142936736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.6162||0.0143|TWO_SIDED|95.0|-2.74|-0.31||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.31|-2.74|0.0143
71765607|NCT00955201|143033580|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.82
71765608|NCT00955201|143033580|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.96
71765609|NCT00955201|143033580|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time||||0.93
71709977|NCT00855166|142936737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.3731||0.0001|TWO_SIDED|95.0|-2.22|-0.74||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.74|-2.22|0.0001
71709978|NCT00855166|142936738|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.3|STANDARD_ERROR_OF_MEAN|5.309|<|0.0001|TWO_SIDED|95.0|15.9|36.7||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender).||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||36.7|15.9|<0.0001
71709979|NCT00855166|142936739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.5652||0.7013|TWO_SIDED|95.0|-0.89|1.34||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||1.34|-0.89|0.7013
71709980|NCT00855166|142936740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.6473||0.1521|TWO_SIDED|95.0|-2.21|0.35||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.35|-2.21|0.1521
71709981|NCT00855166|142936741|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.4428||0.3105|TWO_SIDED|95.0|-1.32|0.43||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||0.43|-1.32|0.3105
71765610|NCT00955201|143033580|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
71765611|NCT00955201|143033580|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wk||||0.31
71765612|NCT00955201|143033580|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 24-wk||||0.28
71765613|NCT00955201|143033581|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.53
71765614|NCT00955201|143033581|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
71709982|NCT02702999|142936742|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
71709983|NCT02702999|142936743|SUPERIORITY||Risk Ratio (RR)|3.9|||||TWO_SIDED|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||18.0|0.9|
71709984|NCT02702999|142936744|SUPERIORITY||Risk Ratio (RR)|1.9|||||TWO_SIDED|95.0|0.4|10.5|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||10.5|0.4|
71709985|NCT02702999|142936745|SUPERIORITY||Risk Ratio (RR)|5.4|||||TWO_SIDED|95.0|1.2|23.7|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||23.7|1.2|
71709986|NCT02702999|142936746|SUPERIORITY||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.03|2.1|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.1|0.03|
71709987|NCT02702999|142936747|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.4|2.3|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).|||2.3|0.4|
71709988|NCT01272219|142936756|SUPERIORITY_OR_OTHER||Estimated mean difference|-5.39|||<|0.0001|TWO_SIDED|95.0|-5.82|-4.95|||ANCOVA||ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg - liraglutide placebo) was statistically significantly smaller than zero.||-4.95|-5.82|<0.0001
71709989|NCT01272219|142936757|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|4.12|5.6|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.60|4.12|<0.0001
71765615|NCT00955201|143033581|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
71765616|NCT00955201|143033581|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
71765617|NCT00955201|143033581|SUPERIORITY|||||||0.8|||||||ANOVA|||Comparison across groups at baseline.||||0.80
71765618|NCT00955201|143033581|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 12-wks||||0.63
71765619|NCT00955201|143033581|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 24-wk||||0.31
71709990|NCT01272219|142936758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.34|||<|0.0001|TWO_SIDED|95.0|3.54|5.32|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing \>10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.||5.32|3.54|<0.0001
71709991|NCT01272219|142936759|SUPERIORITY_OR_OTHER||Treatment estimate|2.681|||<|0.0001|TWO_SIDED|95.0|1.856|3.872|||Weibull analysis||The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo.|If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM ('diabetes-free time'), is statistically significantly \>1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.||3.872|1.856|<.0001
71709992|NCT03131479|142936768|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-9.21||||0.154|TWO_SIDED|90.0|-19.88|1.45|||Regression, Logistic|An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.||||1.45|-19.88|0.154
71765620|NCT00955201|143033582|SUPERIORITY|||||||0.39||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.39
71765621|NCT00955201|143033582|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
71765622|NCT00955201|143033582|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||1.00
71765623|NCT00955201|143033582|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
71765624|NCT00955201|143033582|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline||||0.70
71765625|NCT00955201|143033582|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at 12-wks||||0.45
71765626|NCT00955201|143033582|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24-wks||||0.22
71765627|NCT00955201|143033583|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
71765628|NCT00955201|143033583|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.90
71709993|NCT03131479|142936768|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-6.05||||0.343|TWO_SIDED|90.0|-16.65|4.55|||Regression, Logistic|||||4.55|-16.65|0.343
71709994|NCT03131479|142936768|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-21.5||||0.001|TWO_SIDED|90.0|-31.79|4.55|||Regression, Logistic|||||4.55|-31.79|0.001
71709995|NCT03131479|142936768|EQUIVALENCE|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function\*day and diabetic status\*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-35.6||||0|TWO_SIDED|90.0|-46.0|-25.11|||Regression, Logistic|||||-25.11|-46.00|0.000
71709996|NCT02899754|142936835|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Primary outcome assessed at 1 month post-intervention||||0.18
71709997|NCT02899754|142936837|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71709998|NCT02899754|142936838|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71709999|NCT02899754|142936839|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71765629|NCT00955201|143033583|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
71710000|NCT02899754|142936840|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||0.22
71710001|NCT02899754|142936841|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
71765630|NCT00955201|143033583|SUPERIORITY|||||||0.78||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.78
71765631|NCT00955201|143033583|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at baseline||||0.63
71765632|NCT00955201|143033583|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 12-wk||||0.97
71710002|NCT02899754|142936842|SUPERIORITY|||||||0.01|||||||Chi-squared|||chi-square test||||0.01
71710003|NCT02899754|142936843|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
71710004|NCT02514746|142936887|OTHER||Difference (Group A - B)|-0.6|||||TWO_SIDED|95.0|-7.5|4.5||||||Difference at Year 3||4.5|-7.5|
71710005|NCT02514746|142936887|OTHER||Difference (Group A - B)|0.6|||||TWO_SIDED|95.0|-7.4|6.5||||||Difference at Year 4||6.5|-7.4|
71710006|NCT02514746|142936888|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 3||1.1|0.9|
71710007|NCT02514746|142936888|OTHER||GMT Ratio (Group A/B)|1.0|||||TWO_SIDED|95.0|0.9|1.1||||||Geometric mean titer ratio at Year 4||1.1|0.9|
71710008|NCT02514746|142936889|OTHER||Difference (Group A - B)|-3.7|||||TWO_SIDED|95.0|-8.1|2.8||||||Difference at 7 days post booster vaccination||2.8|-8.1|
71710009|NCT02514746|142936889|OTHER||Difference (Group A - B)|-1.3|||||TWO_SIDED|95.0|-3.3|3.0||||||Difference at 28 days post booster vaccination||3.0|-3.3|
71710010|NCT02514746|142936890|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.5|1.0||||||Geometric mean titer ratio 7 days after booster dose||1.0|0.5|
71710011|NCT02514746|142936890|OTHER||GMT Ratio (Group A/B)|0.7|||||TWO_SIDED|95.0|0.6|0.9||||||Geometric mean titer ratio 28 days after booster dose||0.9|0.6|
71710012|NCT02514746|142936891|OTHER||Difference (Group A - B)|-2.9|||||TWO_SIDED|95.0|-8.0|4.5||||||Difference at 7 days post booster vaccination||4.5|-8.0|
71710013|NCT02514746|142936891|OTHER||Difference (Group A - B)|-1.8|||||TWO_SIDED|95.0|-4.4|3.0||||||Difference at 28 days post booster vaccination||3.0|-4.4|
71710014|NCT02181413|142936897|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.582|0.89|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.|HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.|||0.890|0.582|0.002
71710015|NCT02181413|142936898|SUPERIORITY||Hazard Ratio (HR)|1.025||||0.85|TWO_SIDED|95.0|0.789|1.332||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.332|0.789|0.850
71710016|NCT02181413|142936899|SUPERIORITY||Odds Ratio (OR)|0.732||||0.37|TWO_SIDED|95.0|0.365|1.466||P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by pre-induction regimen, pre-induction international staging system (ISS), and response after transplantation at screening.|Cochran-Mantel-Haenszel||Odds ratio and CI are based on a logistic regression model with treatment group as a categorical predictor variable and pre-induction regimen, pre-induction ISS, and response after transplantation at screening as covariates.|CR||1.466|0.365|0.370
71765633|NCT00955201|143033583|SUPERIORITY|||||||0.99|||||||ANOVA|||Comparison across groups at 24-wks||||0.99
71765634|NCT00955201|143033584|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
71765635|NCT00955201|143033584|SUPERIORITY|||||||0.69||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.69
71765636|NCT00955201|143033584|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.98
71765637|NCT00955201|143033584|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
71765638|NCT00955201|143033584|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline||||0.45
71765639|NCT00955201|143033584|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 12-wks||||0.91
71765640|NCT00955201|143033584|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 24-wks||||0.51
71765641|NCT00955201|143033585|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71886700|NCT02475655|143293605|SUPERIORITY||Mean Difference (Net)|-1.49||||0.7|TWO_SIDED|90.0|-8.06|5.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 12.||5.07|-8.06|0.70
71710017|NCT02181413|142936900|SUPERIORITY||Hazard Ratio (HR)|0.716||||0.002|TWO_SIDED|95.0|0.579|0.886||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||0.886|0.579|0.002
71710018|NCT02181413|142936901|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.902|TWO_SIDED|95.0|0.795|1.298||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.298|0.795|0.902
71710019|NCT02181413|142936902|SUPERIORITY||Hazard Ratio (HR)|0.833||||0.056|TWO_SIDED|95.0|0.69|1.005|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.005|0.690|0.056
71710020|NCT02181413|142936903|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.431|TWO_SIDED|95.0|0.753|1.129||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage, and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.129|0.753|0.431
71710021|NCT02181413|142936904|SUPERIORITY||Hazard Ratio (HR)|1.179|||||TWO_SIDED|95.0|0.959|1.45|||||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.450|0.959|
71710022|NCT02181413|142936906|SUPERIORITY|||||||0.814||||||P-value was based on Fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.814
71710023|NCT02181413|142936907|SUPERIORITY|||||||0.805||||||P-value was based on fisher's exact test comparing conversion to MRD- at any time post study entry between treatment groups.|Fisher Exact|||||||0.805
71710024|NCT02181413|142936908|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.034|TWO_SIDED|95.0|0.386|0.969||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||0.969|0.386|0.034
71710025|NCT02181413|142936908|SUPERIORITY||Hazard Ratio (HR)|0.704||||0.01|TWO_SIDED|95.0|0.539|0.92||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||0.920|0.539|0.010
71710026|NCT02181413|142936909|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.182|TWO_SIDED|95.0|0.414|1.184||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD- at Study Entry||1.184|0.414|0.182
71710027|NCT02181413|142936909|SUPERIORITY||Hazard Ratio (HR)|0.966||||0.847|TWO_SIDED|95.0|0.682|1.368||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|MRD+ at Study Entry||1.368|0.682|0.847
71710028|NCT02181413|142936910|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.905|TWO_SIDED|95.0|0.583|1.613||P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.|Log Rank||Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.|||1.613|0.583|0.905
71710029|NCT02181413|142936915|SUPERIORITY||Least Squares (LS) Mean Difference|-2.3||||0.074|TWO_SIDED|95.0|-4.9|0.2|||t-test, 2 sided|P-value was from the significance test for the coefficient of the interaction between treatment and visit.||||0.2|-4.9|0.074
71710030|NCT02214212|142936928|SUPERIORITY||Slope|-0.16||||0.955|TWO_SIDED|95.0|-5.69|5.37|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.|The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||5.37|-5.69|.955
71710031|NCT02214212|142936929|SUPERIORITY||Mean Difference (Net)|0.69||||0.807|TWO_SIDED|95.0|-4.9|6.29|||Mixed Models Analysis|||||6.29|-4.90|.807
71710032|NCT02214212|142936930|SUPERIORITY||Mean Difference (Net)|-0.48||||0.847|TWO_SIDED|95.0|-5.38|4.43|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.||||4.43|-5.38|.847
71710033|NCT02214212|142936931|SUPERIORITY||Mean Difference (Net)|3.14||||0.252|TWO_SIDED|95.0|-2.29|8.56|||Mixed Models Analysis|Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.||||8.56|-2.29|.252
71826764|NCT00383188|143158061|SUPERIORITY||LSM Difference|-6.895|STANDARD_ERROR_OF_MEAN|3.245||0.0339|TWO_SIDED|95.0|-13.26|-0.524|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.524|-13.26|0.0339
71710034|NCT02214212|142936932|SUPERIORITY||Mean Difference (Net)|0.67||||0.722|TWO_SIDED|95.0|-3.08|4.4|||Mixed Models Analysis|||||4.4|-3.08|.722
71710035|NCT02214212|142936933|SUPERIORITY||Mean Difference (Net)|-2.25||||0.253|TWO_SIDED|95.0|-6.13|1.64|||Mixed Models Analysis|||||1.64|-6.13|.253
71710036|NCT02214212|142936934|SUPERIORITY||Mean Difference (Net)|-0.39||||0.351|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.|A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.|||0.44|-1.21|.351
71710037|NCT02214212|142936935|SUPERIORITY||Slope|0.0||||0.91|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects|The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.|||0.03|-0.03|.910
71710038|NCT02214212|142936936|SUPERIORITY||Mean Difference (Net)|0.857||||0.19|TWO_SIDED|95.0|-1.93|2.32|||Mixed Models Analysis|Mixed-effects model adjusts for treatment time (pre/post)||||2.32|-1.93|0.19
71710039|NCT02214212|142936937|SUPERIORITY||Mean Difference (Net)|-4.8||||0.345|TWO_SIDED|95.0|-14.83|5.24|||Mixed Models Analysis|Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.||||5.24|-14.83|.345
71710040|NCT04903093|142936941|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|96.96|||||TWO_SIDED|90.0|85.43|110.03||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||110.03|85.43|
71710041|NCT04903093|142936941|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio (%) of adjusted geometric means|62.87|||||TWO_SIDED|90.0|54.85|72.07||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commecial tablet; Reference: Abrocitinib 200 mg commercial tablet||72.07|54.85|
71710042|NCT04903093|142936942|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|100.07|||||TWO_SIDED|90.0|80.28|124.74||||||Test: Abrocitinib 200 mg oral suspension formulation 1; Reference: Abrocitinib 200 mg commercial tablet||124.74|80.28|
71710043|NCT04903093|142936942|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of adjusted geometric means|15.53|||||TWO_SIDED|90.0|12.46|19.36||||||Test: Famotidine 40 mg tablet + Abrocitinib 200 mg commercial tablet; Reference: Abrocitinib 200 mg commercial tablet||19.36|12.46|
71710044|NCT03555994|142936961|SUPERIORITY||Least square mean difference|-105.7||||0.023||90.0|-178.8|-32.6|||ANCOVA|||||-32.6|-178.8|0.023
71710045|NCT03555994|142936962|SUPERIORITY||Least square mean difference|-25.87||||0.008||90.0|-40.88|-10.86|||ANCOVA|||||-10.86|-40.88|0.008
71710046|NCT03555994|142936963|SUPERIORITY||Least Square Mean difference|-21.99||||0.008||90.0|-34.55|-9.43|||ANCOVA|||||-9.43|-34.55|0.008
71710047|NCT03555994|142936964|SUPERIORITY||Least Square Mean difference|-35.06||||0.07||90.0|-66.54|-3.58|||ANCOVA|||||-3.58|-66.54|0.070
71710048|NCT03555994|142936964|SUPERIORITY||Least Square Mean difference|-11.72||||0.03||90.0|-20.13|-3.3|||ANCOVA|||||-3.30|-20.13|0.030
71710049|NCT00392288|142936976|SUPERIORITY_OR_OTHER|||||||0.2696||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.||||0.2696
71710050|NCT00392288|142936976|SUPERIORITY_OR_OTHER|||||||0.0703||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.||||0.0703
71710051|NCT00392288|142936976|SUPERIORITY_OR_OTHER|||||||0.9146||95.0||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age \[yrs\] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.||||0.9146
71710052|NCT02544763|142936979|SUPERIORITY||Percentage reduction|48.6|||||TWO_SIDED|95.0|40.4|55.8||||||||55.8|40.4|
71710053|NCT02544763|142936979|SUPERIORITY||Percentage reduction|47.5|||||TWO_SIDED|95.0|39.0|54.8||||||||54.8|39.0|
71710054|NCT02544763|142936979|SUPERIORITY||Percentage reduction|26.5|||||TWO_SIDED|95.0|14.9|36.5||||||||36.5|14.9|
71710055|NCT02544763|142936979|SUPERIORITY||Treatment ratio|0.699|||=|0.0009|TWO_SIDED|95.0|0.567|0.861|||Mixed Models Analysis|||||0.861|0.567|=0.0009
71710056|NCT02544763|142936979|SUPERIORITY||Treatment ratio|0.715|||=|0.0018|TWO_SIDED|95.0|0.58|0.881|||Mixed Models Analysis|||||0.881|0.580|=0.0018
71765642|NCT00955201|143033585|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.72
71826765|NCT00383188|143158061|SUPERIORITY||LSM Difference|-8.891|STANDARD_ERROR_OF_MEAN|3.771||0.0186|TWO_SIDED|95.0|-16.29|-1.488|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.488|-16.29|0.0186
71710057|NCT02544763|142936980|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.0692|TWO_SIDED|95.0|0.95|4.0|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.00|0.95|=0.0692
71710058|NCT02544763|142936980|SUPERIORITY||Odds Ratio (OR)|2.29|||=|0.0245|TWO_SIDED|95.0|1.12|4.67|||Cochran-Mantel-Haenszel|The p-value was calculated from a Cochran-Mantel-Haenszel test stratified by age group (1-6, 7-11, 12-17 and 18-65 years).||||4.67|1.12|=0.0245
71710059|NCT02544763|142936981|SUPERIORITY||Odds Ratio (OR)|2.25|||=|0.0074|TWO_SIDED|95.0|1.24|4.07|||nominal|The global impression of change was analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||4.07|1.24|=0.0074
71710060|NCT02544763|142936981|SUPERIORITY||Odds Ratio (OR)|1.77|||=|0.058|TWO_SIDED|95.0|0.98|3.2|||nominal|The global impression of change is analyzed using an ordinal logistic regression model with treatment group as a fixed factor.||||3.20|0.98|=0.0580
71710061|NCT02544763|142936982|SUPERIORITY|Model includes the total number of seizures as a response variable and age group, time (Baseline and treatment period), treatment and treatment by time interaction as fixed effects and participant as a random effect. The log transformed number of days seizures were reported by period is included as an offset.|Percentage reduction|0.519|||||TWO_SIDED|95.0|0.447|0.602||||||||0.602|0.447|
71710062|NCT02544763|142936982|SUPERIORITY||Percentage reduction|0.524|||||TWO_SIDED|95.0|0.452|0.607||||||||0.607|0.452|
71710063|NCT02544763|142936982|SUPERIORITY||Percentage reduction|0.731|||||TWO_SIDED|95.0|0.632|0.846||||||||0.846|0.632|
71710064|NCT02544763|142936982|SUPERIORITY||Treatment ratio|0.709|||=|0.0013|TWO_SIDED|95.0|0.576|0.873|||Mixed Models Analysis|||||0.873|0.576|=0.0013
71710065|NCT02544763|142936982|SUPERIORITY||Treatment ratio|0.716|||=|0.0018|TWO_SIDED|95.0|0.582|0.882|||Mixed Models Analysis|||||0.882|0.582|=0.0018
71710066|NCT00057577|142936997|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Subdistribution hazard model|||||||=.038
71710067|NCT00057577|142936998|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Subdistribution hazard model|||||||<0.01
71710068|NCT04548219|142937001|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.907|||||TWO_SIDED|90.0|0.775|1.06||||||||1.06|0.775|
71710069|NCT04548219|142937002|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.761|1.1||||||||1.10|0.761|
71710070|NCT04548219|142937003|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.915|||||TWO_SIDED|90.0|0.76|1.1||||||||1.10|0.760|
71710071|NCT02613507|142937004|SUPERIORITY|||||||0.0006|TWO_SIDED|||||The boundary for statistical significance requires the p-value to be less than 0.0231|Stratified weighted Log-Rank|Stratified weighted using G \[rho=0, gamma=1\] Fleming and Harrington.||||||0.0006
71710072|NCT02613507|142937004|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|97.7|0.52|0.9|||Stratified Cox Proportional Hazard Model|||||0.90|0.52|
71710073|NCT02613507|142937004|SUPERIORITY|||||||0.0017|||||||Log Rank|regular stratified log-rank test p-value||||||0.0017
71710074|NCT03941093|142937014|OTHER||Hazard Ratio (HR)|1.08||||0.5487|TWO_SIDED|95.0|0.83|1.41|||Stratified Log Rank Test|||||1.41|0.83|0.5487
71710075|NCT05339659|142937018|OTHER|The point null hypothesis of the significance test was a difference in expected number of log ins of 0.|Mean Difference (Final Values)|3.55||||0.219|TWO_SIDED|95.0|-2.33|9.44|||Regression, Linear||mean difference=experimental-control|A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.||9.44|-2.33|0.219
71710076|NCT05339659|142937020|OTHER|The null hypothesis for the significance test is 0 difference in average number of days of use between arms.|Mean Difference (Final Values)|-22.12||||0.153|TWO_SIDED|95.0|-53.44|9.19|||Regression, Linear||mean difference=experimental-control|||9.19|-53.44|0.153
71710077|NCT05339659|142937021|OTHER|The null hypothesis for the significance test is a relative difference=0.|Risk Difference (RD)|0.095||||0.727|TWO_SIDED|95.0|-0.352|0.558|||Barnard's exact test||risk difference=experimental-control|||0.558|-0.352|0.727
71710078|NCT05339659|142937022|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.6|1.61|||Regression, Linear||mean difference=experimental-control|||1.61|-0.60|0.325
71710079|NCT05339659|142937023|OTHER|The null hypothesis of the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|0.22||||0.745|TWO_SIDED|95.0|-1.28|1.72|||Regression, Linear||mean difference=experimental-control|||1.72|-1.28|0.745
71710080|NCT05339659|142937024|OTHER|The null hypothesis of the significance test is a risk difference=0.|Risk Difference (RD)|0.58||||0.009|TWO_SIDED|95.0|0.16|0.85|||Barnard's exact test||risk difference=experimental-control|||0.85|0.16|0.009
71710081|NCT05339659|142937027|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|1.39||||0.469|TWO_SIDED|95.0|-2.66|5.44|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||5.44|-2.66|0.469
71710082|NCT05339659|142937028|OTHER|The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.|Mean Difference (Final Values)|-0.66||||0.614|TWO_SIDED|95.0|-3.48|2.16|||Regression, Linear|Adjusted for baseline cigarettes/day.|mean difference=experimental-control|||2.16|-3.48|0.614
71710083|NCT05339659|142937029|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.14||||0.9|TWO_SIDED|95.0|-2.67|2.38|||Regression, Linear||mean difference=experimental-control|||2.38|-2.67|0.90
71710084|NCT05339659|142937030|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-0.55||||0.632|TWO_SIDED|95.0|-3.03|1.93|||Regression, Linear||mean difference=experimental-control|||1.93|-3.03|0.632
71710085|NCT05339659|142937031|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.31||||0.227|TWO_SIDED|95.0|-3.55|-0.94|||Regression, Linear||mean difference=experimental-control|||-0.94|-3.55|0.227
71710086|NCT05339659|142937032|OTHER|The null hypothesis for the significance test is 0 difference in average score between arms.|Mean Difference (Final Values)|-1.22||||0.274|TWO_SIDED|95.0|-3.58|1.15|||Regression, Linear||mean difference=experimental-control|||1.15|-3.58|0.274
71710087|NCT05339659|142937036|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
71710088|NCT05339659|142937037|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.01||||0.845|TWO_SIDED|95.0|-0.49|0.43|||Barnard's exact test||risk difference=experimental-control|||0.43|-0.49|0.845
71710089|NCT05339659|142937038|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.05||||0.56|TWO_SIDED|95.0|-0.47|0.28|||Barnard's exact test||||risk difference=experimental-control|0.28|-0.47|0.560
71710090|NCT05339659|142937039|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|0.04||||0.981|TWO_SIDED|95.0|-0.39|0.39|||Barnard's exact test||risk difference=experimental-control|||0.39|-0.39|0.981
71710091|NCT05339659|142937040|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.13||||0.632|TWO_SIDED|95.0|-0.49|0.34|||Barnard's exact test||risk difference=experimental-control|||0.34|-0.49|0.632
71826766|NCT00383188|143158061|SUPERIORITY||LSM Difference|-2.714|STANDARD_ERROR_OF_MEAN|3.888||0.4854|TWO_SIDED|95.0|-10.35|4.918|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||4.918|-10.35|0.4854
71710092|NCT05339659|142937041|OTHER|The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.|Risk Difference (RD)|-0.03|||>|0.999|TWO_SIDED|95.0|-0.48|0.45|||Barnard's exact test||risk difference=experimental-control|||0.45|-0.48|>0.999
71710093|NCT03829514|142937066|OTHER|||||||0.05|||||||t-test, 2 sided|Signal intensity data were loess normalized and normalized data were used to perform a limma t-test with empirical Bayes smoothing to standard errors|||Proteins were identified and quantified using EncyclopeDIA and visualized with Scaffold DIA using 1% false discovery thresholds at both the protein and peptide level. Protein exclusive intensity values were assessed for quality using an in-house ProteiNorm app, a tool for systematic evaluation of normalization methods, imputation of missing values and comparisons of multiple differential abundance methods . Cyclic loess normalization. The normalized data were used to perform statistical analysis using linear models for microarray data (limma) with empirical Bayes (eBayes) smoothing to the standard errors. Proteins with p-value \< 0.05 were considered significant.|||0.05
71710094|NCT01339091|142937067|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|1.5|||||TWO_SIDED|95.0|-4.6|7.9|||||Confidence intervals were adjusted for fever at baseline|||7.9|-4.6|
71710095|NCT01149460|142937085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|111.34|||||TWO_SIDED|90.0|100.54|123.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||123.29|100.54|
71710096|NCT01149460|142937086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.34|103.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.82|96.34|
71710097|NCT01149460|142937087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||TWO_SIDED|90.0|96.38|103.78|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||103.78|96.38|
71710098|NCT01149460|142937088|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|103.48|||||TWO_SIDED|90.0|97.87|109.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||109.41|97.87|
71765643|NCT00955201|143033585|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71765644|NCT00955201|143033585|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71826767|NCT00383188|143158061|SUPERIORITY||LSM Difference|-1.387|STANDARD_ERROR_OF_MEAN|3.311||0.6753|TWO_SIDED|95.0|-7.886|5.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||5.112|-7.886|0.6753
71710099|NCT01149460|142937089|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|99.2|||||TWO_SIDED|90.0|97.14|101.31|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.31|97.14|
71710100|NCT01149460|142937090|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means|99.1|||||TWO_SIDED|90.0|97.04|101.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.|||101.19|97.04|
71886701|NCT02475655|143293606|SUPERIORITY||Mean Difference (Net)|0.01||||0.79|TWO_SIDED|90.0|-0.05|0.07||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 5.||0.07|-0.05|0.79
71710101|NCT02272985|142937095|OTHER||||||=|0.03||||||the p value was calculated|Mixed Models Analysis|||||||=0.03
71710102|NCT02272985|142937096|OTHER|||||||0.001|||||||Mixed Models Analysis|||Left frontal gray matter:||||0.001
71710103|NCT02272985|142937096|OTHER|||||||0.08|||||||Mixed Models Analysis|||Right frontal gray matter:||||0.08
71710104|NCT00266032|142937097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_DEVIATION|29.0|<|0.0001||95.0|-29.0|-20.0|||t-test, 2 sided||Mean of Yaz flexible regimen minus mean of Yaz standard was tested|Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.||-20|-29|<0.0001
71710105|NCT01220687|142937142|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.0012|TWO_SIDED||||||t-test, 2 sided|||||||0.0012
71710106|NCT01220687|142937143|SUPERIORITY||Rate Ratio|1.91|||<|0.0001|TWO_SIDED|95.0|1.68|2.18|||Poisson|||||2.18|1.68|<0.0001
71710107|NCT00835042|142937153|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|92.5||||||90.0|85.8|99.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||99.8|85.8|
71710108|NCT00835042|142937154|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|92.2|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.2|
71710109|NCT00835042|142937155|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|92.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106|92.3|
71710110|NCT00835042|142937156|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|99.3|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|99.3|
71710111|NCT00835042|142937157|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|96.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.4|
71710112|NCT00835042|142937158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|96.7|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||102|96.7|
71710113|NCT00835042|142937159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.0||||||90.0|81.8|101.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101|81.8|
71710114|NCT00835042|142937160|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|94.6|103.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103|94.6|
71710115|NCT00835042|142937161|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.6|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||108|97.6|
71765645|NCT00955201|143033585|SUPERIORITY|||||||0.85|||||||ANOVA|||Comparison across groups at baseline||||0.85
71765646|NCT00955201|143033585|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at 12-wks||||0.98
71710116|NCT03715829|142937167|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.62|<|0.0001|TWO_SIDED|90.0|-32.53|-13.96||Hochberg's step-up procedure was conducted to compare ritlecitinib 200mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.96|-32.53|<0.0001
71710117|NCT03715829|142937167|SUPERIORITY||Least Squares Mean Difference (Net)|-23.2|STANDARD_ERROR_OF_MEAN|5.63|<|0.0001|TWO_SIDED|90.0|-32.53|-13.93||Hochberg's step-up procedure was conducted to compare ritlecitinib 100mg - 50mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-13.93|-32.53|<0.0001
71710118|NCT03715829|142937167|SUPERIORITY||Least Squares Mean Difference (Net)|-20.6|STANDARD_ERROR_OF_MEAN|5.84||0.0003|TWO_SIDED|90.0|-30.23|-10.93||Hochberg's step-up procedure was conducted to compare the ritlecitinib 50 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. Hochberg adjusted p-value is presented here.|ANCOVA|||||-10.93|-30.23|0.0003
71710119|NCT03715829|142937167|SUPERIORITY||Least Squares Mean Difference (Net)|-16.7|STANDARD_ERROR_OF_MEAN|6.71||0.0068|TWO_SIDED|90.0|-27.77|-5.61||Hochberg's step-up procedure was conducted to compare the ritlecitinib 30 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||-5.61|-27.77|0.0068
71710120|NCT03715829|142937167|SUPERIORITY||Least Squares Mean Difference (Net)|-5.1|STANDARD_ERROR_OF_MEAN|6.03||0.2015|TWO_SIDED|90.0|-15.02|4.91||Hochberg's step-up procedure was conducted to compare the ritlecitinib 10 mg QD dose group vs placebo using observed p-values. The familywise Type 1 error rate was controlled at one-sided 0.05. One-sided unadjusted p-value is presented here.|ANCOVA|||||4.91|-15.02|0.2015
71710121|NCT03253627|142937222|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||baseline||||0.460
71710122|NCT03253627|142937222|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||3 months||||0.896
71826768|NCT00383188|143158061|SUPERIORITY||LSM Difference|-11.09|STANDARD_ERROR_OF_MEAN|3.244||0.0007|TWO_SIDED|95.0|-17.46|-4.724|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-4.724|-17.46|0.0007
71826769|NCT00383188|143158061|SUPERIORITY||LSM Difference|-9.535|STANDARD_ERROR_OF_MEAN|3.771||0.0116|TWO_SIDED|95.0|-16.94|-2.134|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-2.134|-16.94|0.0116
71710123|NCT03253627|142937223|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||baseline||||0.374
71710124|NCT03253627|142937223|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||6 months||||0.236
71710125|NCT03253627|142937224|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||baseline||||0.180
71710126|NCT03253627|142937224|SUPERIORITY|||||||0.822|||||||t-test, 2 sided|||6 months||||0.822
71710127|NCT03253627|142937225|SUPERIORITY|||||||0.715|||||||t-test, 2 sided|||baseline||||.715
71710128|NCT03253627|142937225|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||3 months||||0.861
71710129|NCT03253627|142937225|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||6 months||||.790
71710130|NCT03253627|142937226|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||baseline||||0.452
71710131|NCT03253627|142937226|SUPERIORITY|||||||0.253|||||||t-test, 2 sided|||3 months||||0.253
71710132|NCT03253627|142937226|SUPERIORITY|||||||0.469|||||||t-test, 2 sided|||6 months||||0.469
71710133|NCT03253627|142937227|SUPERIORITY|||||||0.628|||||||t-test, 2 sided|||baseline||||0.628
71886702|NCT02475655|143293606|SUPERIORITY||Mean Difference (Net)|0.01||||0.91|TWO_SIDED|90.0|-0.07|0.08||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 12.||0.08|-0.07|0.91
71710134|NCT03253627|142937227|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||3 months||||0.345
71710135|NCT03253627|142937227|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||6 months||||0.384
71710136|NCT03253627|142937228|SUPERIORITY|||||||0.398|||||||t-test, 2 sided|||baseline||||.398
71710137|NCT03253627|142937228|SUPERIORITY|||||||0.811|||||||t-test, 2 sided|||3 months||||0.811
71710138|NCT03253627|142937228|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||6 months||||0.027
71710139|NCT01813357|142937239|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.684|TWO_SIDED||||||Mixed Models Analysis|||||||0.684
71710140|NCT03773562|142937241|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Responders vs Non-responders||||0.04
71710141|NCT03773562|142937243|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.002
71710142|NCT03773562|142937244|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Responders vs Non-responders||||0.01
71710143|NCT03773562|142937246|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
71710144|NCT03773562|142937247|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
71710145|NCT03773562|142937248|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||Responder vs non-responder||||0.0003
71710146|NCT03773562|142937249|SUPERIORITY|||||||0.0033|||||||t-test, 2 sided|||Responder vs non-responder||||0.0033
71710147|NCT03773562|142937250|SUPERIORITY|||||||0.0041|||||||t-test, 2 sided|||Responder vs non-responder||||0.0041
71710148|NCT03773562|142937251|SUPERIORITY|||||||0.0046|||||||t-test, 2 sided|||Responder vs non-responder||||0.0046
71710149|NCT01854762|142937252|OTHER||Odds Ratio (OR)|3.1|||<|0.01|TWO_SIDED|95.0|1.3|7.4|||Fisher Exact||||Kaplan-Meier estimates for the proportion of patients without virological failure by weeks 2, 4 and 6, and at delivery, using treatment-related discontinuation equal failure analysis|7.4|1.3|<0.01
71710150|NCT04806373|142937256|OTHER|||||||0.863|||||||Fisher Exact|||||||0.863
71710151|NCT04806373|142937257|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Difference in pleural drainage volume day 1 post-TSP||||0.005
71765647|NCT00955201|143033585|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24-wks||||0.68
71765648|NCT00955201|143033586|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.91
71765649|NCT00955201|143033586|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71765650|NCT00955201|143033586|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.94
71765651|NCT00955201|143033586|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.93
71765652|NCT00955201|143033586|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline||||0.38
71765653|NCT00955201|143033586|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
71765654|NCT00955201|143033586|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 24-wks||||0.94
71765655|NCT00955201|143033587|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71765656|NCT00955201|143033587|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.97
71765657|NCT00955201|143033587|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
71765658|NCT00955201|143033587|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
71765659|NCT00955201|143033587|SUPERIORITY|||||||0.16|||||||ANOVA|||Comparison across groups at baseline.||||0.16
71765660|NCT00955201|143033587|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 12-wks||||0.37
71765661|NCT00955201|143033587|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at 24-wks||||0.75
71765662|NCT00955201|143033588|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
71765663|NCT00955201|143033588|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
71765664|NCT00955201|143033588|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
71765665|NCT00955201|143033588|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
71765666|NCT00955201|143033588|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at baseline||||0.28
71765667|NCT00955201|143033588|SUPERIORITY|||||||0.28|||||||ANOVA|||Comparison across groups at 12-wks||||0.28
71765668|NCT00955201|143033588|SUPERIORITY|||||||0.83|||||||ANOVA|||Comparison across groups at 24-wks||||0.83
71765669|NCT00955201|143033589|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.99
71765670|NCT00955201|143033589|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.97
71765671|NCT00955201|143033589|SUPERIORITY|||||||0.82||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.82
71765672|NCT00955201|143033589|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time||||0.96
71765673|NCT00955201|143033589|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at baseline.||||0.55
71765674|NCT00955201|143033589|SUPERIORITY|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wks||||0.31
71765675|NCT00955201|143033589|SUPERIORITY|||||||0.32|||||||ANOVA|||Comparison across groups at 24-wks||||0.32
71765676|NCT00955201|143033590|SUPERIORITY|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.81
71765677|NCT00955201|143033590|SUPERIORITY|||||||0.92||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.92
71765678|NCT00955201|143033590|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.93
71765679|NCT00955201|143033590|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
71765680|NCT00955201|143033590|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at baseline.||||0.50
71765681|NCT00955201|143033590|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12-wks.||||0.47
71765682|NCT00955201|143033590|SUPERIORITY|||||||0.97|||||||ANOVA|||Comparison across groups at 24-wks||||0.97
71765683|NCT00955201|143033591|SUPERIORITY|||||||0.83||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.83
71765684|NCT00955201|143033591|SUPERIORITY|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.91
71765685|NCT00955201|143033591|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||1.00
71765686|NCT00955201|143033591|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.95
71765687|NCT00955201|143033591|SUPERIORITY|||||||0.26|||||||ANOVA|||Comparison across groups at baseline.||||0.26
71765688|NCT00955201|143033591|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at 12-wks||||0.42
71765689|NCT00955201|143033591|SUPERIORITY|||||||0.95|||||||ANOVA|||Comparison across groups at 24-wks.||||0.95
71765690|NCT00955201|143033592|SUPERIORITY|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.96
71765691|NCT00955201|143033592|SUPERIORITY|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.53
71765692|NCT00955201|143033592|SUPERIORITY|||||||0.79||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.79
71765693|NCT00955201|143033592|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.94
71765694|NCT00955201|143033592|SUPERIORITY|||||||0.75|||||||ANOVA|||Comparison across groups at baseline||||0.75
71765695|NCT00955201|143033592|SUPERIORITY|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks||||0.51
71765696|NCT00955201|143033592|SUPERIORITY|||||||0.63|||||||ANOVA|||Comparison across groups at 24-wks.||||0.63
71826770|NCT00383188|143158061|SUPERIORITY||LSM Difference|-8.322|STANDARD_ERROR_OF_MEAN|3.888||0.0326|TWO_SIDED|95.0|-15.95|-0.691|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-0.691|-15.95|0.0326
71826771|NCT00383188|143158061|SUPERIORITY||LSM Difference|-3.624|STANDARD_ERROR_OF_MEAN|3.309||0.2738|TWO_SIDED|95.0|-10.12|2.872|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.872|-10.12|0.2738
71826772|NCT00383188|143158061|SUPERIORITY||LSM Difference|-9.778|STANDARD_ERROR_OF_MEAN|3.243||0.0026|TWO_SIDED|95.0|-16.14|-3.412|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-3.412|-16.14|0.0026
71826773|NCT00383188|143158061|SUPERIORITY||LSM Difference|-9.339|STANDARD_ERROR_OF_MEAN|3.769||0.0134|TWO_SIDED|95.0|-16.74|-1.941|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||-1.941|-16.74|0.0134
71826774|NCT00383188|143158061|SUPERIORITY||LSM Difference|-5.528|STANDARD_ERROR_OF_MEAN|3.886||0.1553|TWO_SIDED|95.0|-13.16|2.101|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||2.101|-13.16|0.1553
71826775|NCT00383188|143158061|SUPERIORITY||LSM Difference|-0.118|STANDARD_ERROR_OF_MEAN|3.444||0.9726|TWO_SIDED|95.0|-6.878|6.641|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||6.641|-6.878|0.9726
71826776|NCT00383188|143158061|SUPERIORITY||LSM Difference|1.409|STANDARD_ERROR_OF_MEAN|3.321||0.6714|TWO_SIDED|95.0|-5.109|7.928|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||7.928|-5.109|0.6714
71710152|NCT04806373|142937258|OTHER|||||||0.891|||||||Wilcoxon (Mann-Whitney)|||Borg dyspnea scale day 3 post-TSP||||0.891
71710153|NCT04806373|142937259|OTHER|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Pain score at day 3 post-TSP||||0.899
71710154|NCT04806373|142937260|OTHER|||||||0.809|||||||Fisher Exact|||||||0.809
71710155|NCT04806373|142937261|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71826777|NCT00383188|143158061|SUPERIORITY||LSM Difference|0.646|STANDARD_ERROR_OF_MEAN|3.925||0.8693|TWO_SIDED|95.0|-7.058|8.351|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||8.351|-7.058|0.8693
71826778|NCT00383188|143158061|SUPERIORITY||LSM Difference|1.289|STANDARD_ERROR_OF_MEAN|4.035||0.7495|TWO_SIDED|95.0|-6.631|9.208|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline Physician's Global Assessment of Arthritis count as the covariate and participant as a random effect.||9.208|-6.631|0.7495
71826779|NCT00383188|143158062|SUPERIORITY||LSM Difference|-8.983|STANDARD_ERROR_OF_MEAN|4.469||0.0447|TWO_SIDED|95.0|-17.75|-0.214|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-0.214|-17.75|0.0447
71826780|NCT00383188|143158062|SUPERIORITY||LSM Difference|-15.12|STANDARD_ERROR_OF_MEAN|4.345||0.0005|TWO_SIDED|95.0|-23.65|-6.596|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.596|-23.65|0.0005
71826781|NCT00383188|143158062|SUPERIORITY||LSM Difference|-17.07|STANDARD_ERROR_OF_MEAN|4.981||0.0006|TWO_SIDED|95.0|-26.84|-7.296|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-7.296|-26.84|0.0006
71826782|NCT00383188|143158062|SUPERIORITY||LSM Difference|-16.26|STANDARD_ERROR_OF_MEAN|5.218||0.0019|TWO_SIDED|95.0|-26.49|-6.018|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-6.018|-26.49|0.0019
71710156|NCT04806373|142937262|OTHER|||||||0.808|||||||Wilcoxon (Mann-Whitney)|||||||0.808
71710157|NCT04806373|142937263|OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
71710158|NCT04806373|142937264|OTHER|||||||0.714|||||||t-test, 2 sided|||||||0.714
71710159|NCT04806373|142937265|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71710160|NCT00373360|142937311|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71710161|NCT00373360|142937312|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.008
71710162|NCT00373360|142937313|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71710163|NCT00373360|142937314|SUPERIORITY_OR_OTHER|||||||0.531||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.531
71710164|NCT00373360|142937315|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71710165|NCT00373360|142937316|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.500
71710166|NCT00373360|142937317|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71710167|NCT00373360|142937318|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||1.000
71710168|NCT00373360|142937319|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0
71710169|NCT00373360|142937320|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||1.000
71710170|NCT00373360|142937321|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
71710171|NCT00373360|142937322|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.031
71710172|NCT00373360|142937323|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
71710173|NCT00373360|142937324|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.063
71710174|NCT00373360|142937325|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Wilcoxon signed rank test|||Change Between Baseline and Week 8||||0.203
71710175|NCT00373360|142937329|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||0.250
71710176|NCT00373360|142937330|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.207
71710177|NCT00373360|142937331|SUPERIORITY_OR_OTHER|||||||0.297||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.297
71710178|NCT00373360|142937332|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon signed rank test|||Change between Baseline and Week 8||||0.004
71710179|NCT00787800|142937336|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Log Rank|||||||1.0
71765697|NCT00955201|143033593|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.98
71710180|NCT00787800|142937338|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.050
71710181|NCT00787800|142937340|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71710182|NCT00913835|142937364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.054||||0.8049|TWO_SIDED|90.0|0.751|1.478|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.478|0.751|0.8049
71765698|NCT00955201|143033593|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.99
71765699|NCT00955201|143033593|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.||||0.89
71765700|NCT00955201|143033593|SUPERIORITY|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.90
71765701|NCT00955201|143033593|SUPERIORITY|||||||0.98|||||||ANOVA|||Comparison across groups at baseline||||0.98
71765702|NCT00955201|143033593|SUPERIORITY|||||||0.94|||||||ANOVA|||Comparison across groups at 12-wks||||0.94
71765703|NCT00955201|143033593|SUPERIORITY|||||||0.91|||||||ANOVA|||Comparison across groups at 24-wks.||||0.91
71710183|NCT00913835|142937365|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.115||||0.6346|TWO_SIDED|90.0|0.768|1.618|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.||||1.618|0.768|0.6346
71710184|NCT00913835|142937366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.6190
71710185|NCT01308788|142937377|SUPERIORITY_OR_OTHER|||||||0.4414||95.0|||||ANCOVA|||||||.4414
71710186|NCT01308788|142937378|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.7820
71710187|NCT01308788|142937379|SUPERIORITY_OR_OTHER|||||||0.5496||95.0|||||ANCOVA|||||||.5496
71710188|NCT01308788|142937380|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||ANCOVA|||||||.2930
71710189|NCT01308788|142937381|SUPERIORITY_OR_OTHER|||||||0.5058||95.0|||||ANCOVA|||||||.5058
71710190|NCT01308788|142937382|SUPERIORITY_OR_OTHER|||||||0.6156||95.0|||||ANCOVA|||||||.6156
71710191|NCT01308788|142937383|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||||||.5443
71710192|NCT01308788|142937384|SUPERIORITY_OR_OTHER|||||||0.7847||95.0|||||ANCOVA|||||||.7847
71710193|NCT01308788|142937385|SUPERIORITY_OR_OTHER|||||||0.1331||95.0|||||ANCOVA|||||||.1331
71710194|NCT01308788|142937386|SUPERIORITY_OR_OTHER|||||||0.5431||95.0|||||ANCOVA|||||||.5431
71765704|NCT00955201|143033594|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
71765705|NCT00955201|143033594|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
71765706|NCT00955201|143033594|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
71765707|NCT00955201|143033594|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71765708|NCT00955201|143033594|SUPERIORITY|||||||0.96|||||||ANOVA|||Comparison across groups at baseline.||||0.96
71765709|NCT00955201|143033594|SUPERIORITY|||||||0.86|||||||ANOVA|||Comparison across groups at 12-wks.||||0.86
71765710|NCT00955201|143033594|SUPERIORITY|||||||0.92|||||||ANOVA|||Comparison across groups at 24-wks.||||0.92
71765711|NCT00955201|143033595|SUPERIORITY|||||||0.03||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.03
71765712|NCT00955201|143033595|SUPERIORITY|||||||0.29||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.29
71765713|NCT00955201|143033595|SUPERIORITY|||||||0.36||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.36
71765714|NCT00955201|143033595|SUPERIORITY|||||||0.15||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.||||0.15
71765715|NCT00955201|143033595|SUPERIORITY|||||||0.2||||||ANOVA|ANOVA|||Comparison of pre- and post-responses across groups at baseline.||||0.20
71765716|NCT00955201|143033595|SUPERIORITY|||||||0.51||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 12 wks.||||0.51
71710195|NCT01308788|142937387|SUPERIORITY_OR_OTHER|||||||0.0684||95.0|||||ANCOVA|||||||.0684
71765717|NCT00955201|143033595|SUPERIORITY|||||||0.59||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 24 wks.||||0.59
71765718|NCT00955201|143033596|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
71765719|NCT00955201|143033596|SUPERIORITY|||||||0.01||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.01
71710196|NCT01308788|142937388|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||.2500
71710197|NCT01308788|142937389|SUPERIORITY_OR_OTHER|||||||0.6896||95.0|||||ANCOVA|||||||.6896
71710198|NCT01308788|142937390|SUPERIORITY_OR_OTHER|||||||0.7965||95.0|||||ANCOVA|||||||.7965
71710199|NCT02414841|142937391|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.932|TWO_SIDED|95.0|0.67|1.39|||Log Rank|Weighted|Performed as sensitivity analysis|||1.39|0.67|0.932
71710200|NCT02414841|142937392|SUPERIORITY|||||||0.328|||||||Chi-squared|||||||0.328
71710201|NCT02657356|142937422|SUPERIORITY||LS Mean difference (Net)|-12.86|STANDARD_ERROR_OF_MEAN|7.012||0.0683|TWO_SIDED|95.0|-26.69|0.98|||Mixed Models Analysis|Covariates: screening 6MWT, day 1 hemoglobin, treatment grp, # of PAH medications, time, interactions btwn treatment \& time, and screening 6MWT \& time|Difference is bardoxolone methyl - placebo|||0.98|-26.69|0.0683
71765720|NCT00955201|143033596|SUPERIORITY|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||1.00
71710202|NCT02657356|142937423|SUPERIORITY||Hazard Ratio (HR)|1.984||||0.0004|TWO_SIDED|95.0|1.36|2.895|||Chi-squared||Estimated from Cox Regression adjusted by baseline PAH medication status (0-1 vs 2) as the covariate. Hazard ratio \>1 indicates a beneficial effect that favors bardoxolone methyl.|||2.895|1.360|0.0004
71710203|NCT03379870|142937424|SUPERIORITY|Analyzed Consonant Nucleus Consonant (CNC) Word scores obtained 12-months post-activation to evaluate differences between groups. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores \<20%).||||||0.768||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.768
71710204|NCT03379870|142937425|SUPERIORITY|Analyzed BKB-SIN scores obtained 12-months post-activation to evaluate differences between groups. Scores range from -6 to +21 and lower scores are better.||||||0.529||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.529
71710205|NCT03379870|142937426|SUPERIORITY|Analyzed SSQ scores obtained pre-operatively and at 12-months post-activation to evaluate benefit of cochlear implantation.||||||0.01||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||.010
71710206|NCT03379870|142937427|SUPERIORITY|Analyzed receptive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.|||||>|0.069||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||||||>.069
71710207|NCT03379870|142937428|SUPERIORITY|Analyzed articulation scores pre-operative and 12-months post activation to test for change over time and differences between groups.||||||0.02||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post-activation)||||||.02
71710208|NCT03379870|142937429|SUPERIORITY|Analyzed expressive language scores pre-operatively and 12-months post activation to test for change over time and differences between groups.||||||0.007||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|Main effect of test point (pre-operative vs post activation)||||||.007
71765721|NCT00955201|143033596|SUPERIORITY|||||||0.98||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time||||0.98
71765722|NCT00955201|143033596|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.96
71765723|NCT00955201|143033596|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.06
71765724|NCT00955201|143033596|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.14
71765725|NCT00955201|143033597|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71765726|NCT00955201|143033597|SUPERIORITY|||||||0.36||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.36
71765727|NCT00955201|143033597|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
71765728|NCT00955201|143033597|SUPERIORITY|||||||0.46||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.46
71765729|NCT00955201|143033597|SUPERIORITY|||||||0.14|||||||ANOVA|||Comparison across groups at baseline.||||0.14
71765730|NCT00955201|143033597|SUPERIORITY|||||||0.05|||||||ANOVA|||Comparison across groups at 12 wks.||||0.05
71765731|NCT00955201|143033597|SUPERIORITY|||||||0.01|||||||ANOVA|||Comparison across groups at 24 wks.||||0.01
71765732|NCT00955201|143033598|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
71765733|NCT00955201|143033598|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
71765734|NCT00955201|143033598|SUPERIORITY|||||||0.67||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.67
71765735|NCT00955201|143033598|SUPERIORITY|||||||0.55||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.55
71765736|NCT00955201|143033598|SUPERIORITY|||||||0.4||||||Tukey's multiple comparisons test:|ANOVA|||Comparison across groups at baseline.||||0.40
71765737|NCT00955201|143033598|SUPERIORITY|||||||0.47|||||||ANOVA|||Comparison across groups at 12 wks.||||0.47
71765738|NCT00955201|143033598|SUPERIORITY|||||||0.43|||||||ANOVA|||Comparison across groups at 24 wks.||||0.43
71765739|NCT00955201|143033599|SUPERIORITY|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.84
71765740|NCT00955201|143033599|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
71765741|NCT00955201|143033599|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
71765742|NCT00955201|143033599|SUPERIORITY|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.94
71655435|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|1.01|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.7|3.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.7|
71710209|NCT02943499|142937439|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.||||0.92
71886703|NCT02475655|143293607|SUPERIORITY||Mean Difference (Net)|-2.85||||0.43|TWO_SIDED|90.0|-8.82|3.12||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 5.||3.12|-8.82|0.43
71710210|NCT00557440|142937449|SUPERIORITY_OR_OTHER||LS Mean Difference|0.165|STANDARD_ERROR_OF_MEAN|0.0492||0.001|TWO_SIDED|95.0|0.066|0.263||Statistical significance (two-sided) at 5% level. p-values were not corrected for multiplicity.|ANCOVA|Treatment, period, sequence and center as fixed effects, period baseline FEV1 as a covariate, and patient nested within sequence as a random effect.||||0.263|0.066|0.001
71710211|NCT03524157|142937454|NON_INFERIORITY|it will be considered non-inferior if there are no differences greater than 20%.||||||0.273|||||||Kruskal-Wallis|||||||0.273
71710212|NCT03524157|142937455|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.788|||||||Kruskal-Wallis|||||||0.788
71710213|NCT03524157|142937457|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71710214|NCT03524157|142937458|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%||||||0.008|||||||Kruskal-Wallis|||||||0.008
71710215|NCT03524157|142937459|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71886704|NCT02475655|143293607|SUPERIORITY||Mean Difference (Net)|0.03||||0.99|TWO_SIDED|90.0|-6.53|6.6||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 12.||6.60|-6.53|0.99
71710216|NCT03524157|142937461|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71886705|NCT02475655|143293608|SUPERIORITY||Median Difference (Net)|1.88||||0.007|TWO_SIDED|90.0|1.29|2.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 5.||2.73|1.29|0.007
71710217|NCT03524157|142937462|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71710218|NCT03524157|142937463|NON_INFERIORITY|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared|||||||>0.05
71710219|NCT01592747|142937464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.659|TWO_SIDED|95.0|0.7|1.8|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. memantine full dose.||1.8|0.7|0.6590
71710220|NCT01592747|142937464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7839|TWO_SIDED|95.0|0.7|1.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. Memantine reduced dose||1.7|0.7|0.7839
71710221|NCT01592747|142937466|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.8136|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.8136
71710222|NCT01592747|142937466|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9244|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.9244
71710223|NCT01592747|142937467|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.7611|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.7611
71710224|NCT01592747|142937467|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3176|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3176
71710225|NCT01592747|142937468|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.902|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.9020
71710226|NCT01592747|142937468|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.1279|TWO_SIDED|95.0|-0.1|1.0|||ANCOVA|||||1.0|-0.1|0.1279
71710227|NCT01592747|142937469|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4144|TWO_SIDED|95.0|-0.4|1.1|||ANCOVA|||||1.1|-0.4|0.4144
71886706|NCT02475655|143293608|SUPERIORITY||Mean Difference (Net)|1.31||||0.23|TWO_SIDED|90.0|0.9|1.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 12.||1.90|0.90|0.23
71710228|NCT01592747|142937469|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4212|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4212
71710229|NCT01592747|142937470|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6238|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.6238
71710230|NCT01592747|142937470|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.5957|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||||0.9|-0.5|0.5957
71710231|NCT01592747|142937471|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1||||0.864|TWO_SIDED|95.0|-0.6|0.7|||ANCOVA|||||0.7|-0.6|0.8640
71710232|NCT01592747|142937471|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4362|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.4362
71710233|NCT01592747|142937472|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.7182|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.7182
71710234|NCT01592747|142937472|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.839|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|0.8390
71710235|NCT01592747|142937473|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||0.0813|TWO_SIDED|95.0|-0.1|1.4|||ANCOVA|||||1.4|-0.1|0.0813
71710236|NCT01592747|142937473|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4365|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4365
71710237|NCT01592747|142937474|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4213|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4213
71710238|NCT01592747|142937474|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.4267|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.4267
71710239|NCT01592747|142937475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||0.3713||95.0|-0.4|1.0|||ANCOVA|||||1.0|-0.4|0.3713
71710240|NCT01592747|142937475|SUPERIORITY_OR_OTHER||Least squares mean difference|0.4||||0.2855|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.2855
71710241|NCT02853136|142937476|OTHER||Adjusted geometric Mean ratio [%]|3107.8|||||TWO_SIDED|90.0|2332.9|4140.1|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\] =42.7.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4140.10|2332.90|
71710242|NCT02853136|142937477|OTHER||Adjusted geometric Mean ratio [%]|659.0|||||TWO_SIDED|90.0|489.791|886.676|||||The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2. Intra-individual geometric coefficient of variation \[%\]=44.8.|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||886.676|489.791|
71710243|NCT02853136|142937478|OTHER||Adjusted geometric Mean ratio [%]|3103.41|||||TWO_SIDED|90.0|2330.5|4132.65|||||"The estimated parameter was the adjusted geometric Mean (gMean) ratio \[%\] = adjusted gMean T2/ adjusted gMean R2.~Intra-individual geometric coefficient of variation \[%\] =42.7."|The statistical model used for the analysis of the endpoint was an ANOVA (Analysis of Variance) model. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||4132.65|2330.50|
71710244|NCT04620668|142937485|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
71710245|NCT04620668|142937485|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
71710246|NCT04620668|142937485|SUPERIORITY|||||||0.044|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.044
71710247|NCT04620668|142937485|SUPERIORITY|||||||0.001|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.001
71710248|NCT04620668|142937485|SUPERIORITY|||||||0.731|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.731
71710249|NCT04620668|142937486|SUPERIORITY||||||<|0.001|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||<0.001
71710250|NCT04620668|142937486|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|Assessing change within treatment group (follow-up to Mixed ANOVA).||||||<0.001
71710251|NCT04620668|142937486|SUPERIORITY|||||||0.05|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from baseline to week 2 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.05
71710252|NCT04620668|142937486|SUPERIORITY|||||||0.024|||||||Dependent t-test (2-sided)|"Assessing change within treatment group from week 2 to week 4 (follow-up to Repeated Measures ANOVA).~Bonferroni-adjusted p value."||||||0.024
71710253|NCT04620668|142937486|SUPERIORITY|||||||0.674|||||||Repeated Measures ANOVA|Assessing change within control group (follow-up to Mixed ANOVA).||||||0.674
71710254|NCT04620668|142937487|SUPERIORITY|||||||0.159|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.159
71710255|NCT04620668|142937488|SUPERIORITY|||||||0.326|||||||Mixed ANOVA|Assessing interaction between experimental group and time point.||||||0.326
71738985|NCT00620113|142990732|SUPERIORITY_OR_OTHER||Difference in LS Means|3.84|||<|0.001|TWO_SIDED|95.0|2.37|5.3||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||5.30|2.37|<0.001
71765743|NCT00955201|143033599|SUPERIORITY|||||||0.88|||||||ANOVA|||Comparison across groups at baseline.||||0.88
71765744|NCT00955201|143033599|SUPERIORITY|||||||0.48|||||||ANOVA|||Comparison across groups at 12 wks.||||0.48
71765745|NCT00955201|143033599|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
71710256|NCT05273437|142937508|OTHER|We conducted a Bayesian Regression for all available participants, then visualized the results. (N x 16 table, N: number of participants).|Credibility interval|80.0|||||TWO_SIDED||||||Bayesian Regression|We explicitly sought 80% credibility of at least 100 steps more within the 3-hour increment in comparison to the intervention.|We decided that 100 steps/3 hours is the minimum value of the MAP intervention effect estimate and that an INUS condition is valid only if there is at least an 80% chance of achieving an effect beyond 100 steps/3 hours.|We hypothesized that some individuals have their own time and decision-policy-specific response pattern regardless of day elapsed since the beginning of the intervention. We did not hypothesize the direction of the effect variation.|The decision point was the unit of analysis. For the Bayesian Regression, we used Markov Chain Monte Carlo (MCMC). Four sampling chains were used when performing Bayesian modeling. The number of estimation samples and target acceptance rate were gradually increased until numerical stability was achieved. The number of estimation samples was increased by multiplied by 2, as advised by previous literature, depending on the ratio of convergence diagnostics R̂ \> 1.1. We used 100 steps increase during 3 hours as the effect threshold value. We assumed that there is an effect only if the estimated effect is more than 80% probable (i.e., the credibility interval is over 100 steps/3 hours) and the Maximum A Posteriori Point (MAP) of the effect is more than 100 steps/3 hours. Otherwise, there is no effect. Among the models with effects, we clipped to 1000 steps/3hours as a maximum if the MAP was greater than 1000 steps/3 hours.|||
71710257|NCT01916226|142937517|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|-0.3||0.278|TWO_SIDED|95.0|-0.7|0.2||Estimating the standard deviation of CFB in rTNSS over 2 weeks to be approximately 2.6, a two-sample t-test with α=0.05 suggests that a sample size of 144 participants per arm would provide 90% power to show a difference of 1.0 between treatments.|ANCOVA|||||0.2|-0.7|0.278
71710258|NCT03163667|142937524|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.07905|TWO_SIDED|95.0|0.34|1.2||One-sided p-value comparing the treatment groups was based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CB-839+Everolimus (CBE), and a hazard ratio \> 1 favors Placebo+Everolimus (PboE).|Stratified analysis. Stratification factors were Memorial Sloan Kettering Cancer Center (MSKCC) Prognostic Risk (favorable versus intermediate/poor risk) and number of prior therapies with a tyrosine kinase inhibitor (TKI; 1 versus \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.20|0.34|0.07905
71710259|NCT03163667|142937524|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1184|TWO_SIDED|95.0|0.37|1.28||One-sided p-value comparing the treatment groups was based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.28|0.37|0.1184
71710260|NCT03163667|142937525|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4801|TWO_SIDED|95.0|0.42|1.5||P-value comparing the treatment groups is based on a stratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Stratified analysis: Stratification factors are MSKCC Prognostic Risk (favorable vs intermediate/poor risk) and number of prior therapies with a TKI (1 vs \> 1). Due to stratification cells having \< 10 events, TKI stratification factor was removed for analysis.||1.50|0.42|0.4801
71710261|NCT03163667|142937525|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5603|TWO_SIDED|95.0|0.44|1.56||P-value comparing the treatment groups is based on an unstratified log-rank test with alternative hypothesis of survival functions being not equal.|Log Rank||Hazard ratio comparing treatment groups (experimental over control) is based on a Cox proportional hazards model. A hazard ratio \< 1 favors CBE, and a hazard ratio \> 1 favors PboE.|Unstratified analysis||1.56|0.44|0.5603
71710262|NCT04910165|142937534|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71710263|NCT04910165|142937535|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71710264|NCT04910165|142937536|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71710265|NCT04910165|142937537|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71710266|NCT04910165|142937538|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Wilcoxon (Mann-Whitney)|||||||<0.05
71710267|NCT04910165|142937539|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
71765746|NCT00955201|143033600|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
71710268|NCT04910165|142937540|SUPERIORITY||||||<|0.05||||||p-values reported are calculated by the listed statistical test.|Fisher Exact|||||||<0.05
71765747|NCT00955201|143033600|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
71765748|NCT00955201|143033600|SUPERIORITY|||||||0.51||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.51
71765749|NCT00955201|143033600|SUPERIORITY|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.89
71765750|NCT00955201|143033600|SUPERIORITY|||||||0.46|||||||ANOVA|||Comparison across groups at baseline.||||0.46
71765751|NCT00955201|143033600|SUPERIORITY|||||||0.72|||||||ANOVA|||Comparison across groups at 12 wks.||||0.72
71765752|NCT00955201|143033600|SUPERIORITY|||||||0.22|||||||ANOVA|||Comparison across groups at 24wks.||||0.22
71765753|NCT00955201|143033601|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
71765754|NCT00955201|143033601|SUPERIORITY|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.99
71765755|NCT00955201|143033601|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
71710269|NCT01111552|142937567|SUPERIORITY||Treatment Difference|-1.3|||=|0.595|TWO_SIDED|95.0|-5.9|3.4|||ANCOVA|||||3.4|-5.9|=0.595
71710270|NCT01111552|142937567|SUPERIORITY||Treatment Difference|0.4|||=|0.869|TWO_SIDED|95.0|-4.4|5.1|||ANCOVA|||||5.1|-4.4|=0.869
71710271|NCT01111552|142937568|SUPERIORITY||Treatment Difference|-0.1|||=|0.856|TWO_SIDED|95.0|-0.7|0.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.6|-0.7|=0.856
71710272|NCT01111552|142937568|SUPERIORITY||Treatment Difference|0.1|||=|0.838|TWO_SIDED|95.0|-0.6|0.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.7|-0.6|=0.838
71710273|NCT01111552|142937569|SUPERIORITY||Treatment Difference|-0.2|||=|0.765|TWO_SIDED|95.0|-1.6|1.2|||ANCOVA|||||1.2|-1.6|=0.765
71710274|NCT01111552|142937569|SUPERIORITY||Treatment Difference|0.2|||=|0.76|TWO_SIDED|95.0|-1.2|1.6|||ANCOVA|||||1.6|-1.2|=0.760
71710275|NCT02528305|142937577|SUPERIORITY_OR_OTHER|||||||0.474|||||||ANOVA|||||||0.474
71710276|NCT02528305|142937578|SUPERIORITY_OR_OTHER|||||||0.174|||||||ANOVA|||||||0.174
71710277|NCT02528305|142937579|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
71710278|NCT02528305|142937580|SUPERIORITY|||||||0.023|||||||ANOVA|||||||0.023
71710279|NCT02528305|142937581|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|For the analysis of Total body fat||||||0.092
71765756|NCT00955201|143033601|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
71710280|NCT02528305|142937581|SUPERIORITY_OR_OTHER|||||||0.101|||||||ANOVA|For the analysis of Trunk fat||||||0.101
71765757|NCT00955201|143033601|SUPERIORITY|||||||0.39|||||||ANOVA|||Comparison across groups at baseline.||||0.39
71765758|NCT00955201|143033601|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at 12-wks.||||0.59
71710281|NCT02528305|142937582|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANOVA|For the analysis of systolic blood pressure||||||0.771
71710282|NCT02528305|142937582|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA|For the analysis of diastolic blood pressure||||||0.028
71710283|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.099|||||||ANOVA|For the analysis of Physical Function||||||0.099
71710284|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.566|||||||ANOVA|For the analysis of Social Function||||||0.566
71710285|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.246|||||||ANOVA|For the analysis of Mental Health||||||0.246
71710286|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|For the analysis of Pain||||||0.145
71710287|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.085|||||||ANOVA|For the analysis of Change in Health||||||0.085
71710288|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANOVA|For the analysis of Physical Role Limitation||||||0.114
71710289|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.841|||||||ANOVA|For the analysis of Mental Role Limitation||||||0.841
71710290|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.366|||||||ANOVA|For the analysis of Energy/Vitality||||||0.366
71710291|NCT02528305|142937583|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|For the analysis of Health Perception||||||0.745
71710292|NCT02528305|142937584|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANOVA|||||||0.310
71710293|NCT02528305|142937585|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71710294|NCT02528305|142937586|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
71710295|NCT02528305|142937587|SUPERIORITY_OR_OTHER|||||||0.793|||||||ANOVA|||||||0.793
71710296|NCT02528305|142937588|SUPERIORITY_OR_OTHER|||||||0.513|||||||ANOVA|||||||0.513
71710297|NCT02528305|142937589|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANOVA|||||||0.009
71710298|NCT01852214|142937594|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
71710299|NCT01852214|142937595|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|||||||0.086
71710300|NCT02691494|142937605|SUPERIORITY||Odds Ratio (OR)|28.73|||<|0.001|TWO_SIDED|95.0|12.248|67.387||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||67.387|12.248|< 0.001
71710301|NCT02691494|142937605|SUPERIORITY||Odds Ratio (OR)|28.31|||<|0.001|TWO_SIDED|95.0|13.042|61.431||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||61.431|13.042|< 0.001
71710302|NCT02691494|142937606|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|21.7|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71710303|NCT02691494|142937606|SUPERIORITY||LS Mean of Difference|-164.6|STANDARD_ERROR_OF_MEAN|18.87|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71710304|NCT02691494|142937607|SUPERIORITY||Between-Group Difference (%)|84.2|||<|0.001|TWO_SIDED|95.0|75.99|92.37||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||92.37|75.99|< 0.001
71710305|NCT02691494|142937607|SUPERIORITY||Between-Group Difference (%)|56.3|||<|0.001|TWO_SIDED|95.0|47.77|64.91||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||64.91|47.77|< 0.001
71765759|NCT00955201|143033601|SUPERIORITY|||||||0.29|||||||ANOVA|||Comparison across groups at 24-wks.||||0.29
71765760|NCT00955201|143033602|SUPERIORITY|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time||||0.97
71765761|NCT00955201|143033602|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71765762|NCT00955201|143033602|SUPERIORITY|||||||0.09||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.09
71765763|NCT00955201|143033602|SUPERIORITY|||||||0.05||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.05
71765764|NCT00955201|143033602|SUPERIORITY|||||||0.11|||||||ANOVA|||Comparison across groups at baseline.||||0.11
71765765|NCT00955201|143033602|SUPERIORITY|||||||0.41|||||||ANOVA|||Comparison across groups at 12-wks.||||0.41
71765766|NCT00955201|143033602|SUPERIORITY|||||||0.03|||||||ANOVA|||Comparison across groups at 24-wks.||||0.03
71826783|NCT00383188|143158062|SUPERIORITY||LSM Difference|-3.841|STANDARD_ERROR_OF_MEAN|4.366||0.3792|TWO_SIDED|95.0|-12.41|4.726|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.726|-12.41|0.3792
71655436|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-1.4|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.9|-1.4|
71765767|NCT00955201|143033603|SUPERIORITY|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.95
71765768|NCT00955201|143033603|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71765769|NCT00955201|143033603|SUPERIORITY|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.87
71765770|NCT00955201|143033603|SUPERIORITY|||||||0.48||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.48
71655437|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.0|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-2.0|
71655438|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|0.36|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-2.3|3.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.3|
71655439|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.3|1.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-4.3|
71655440|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.51|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-4.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-4.2|
71655441|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|1.3652|||TWO_SIDED|95.0|-3.5|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-3.5|
71765771|NCT00955201|143033603|SUPERIORITY|||||||0.58|||||||ANOVA|||Comparison across groups at baseline.||||0.58
71765772|NCT00955201|143033603|SUPERIORITY|||||||0.5|||||||ANOVA|||Comparison across groups at 12-wks.||||0.50
71765773|NCT00955201|143033603|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 24-wks.||||0.33
71765774|NCT00955201|143033604|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
71765775|NCT00955201|143033604|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71765776|NCT00955201|143033604|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
71765777|NCT00955201|143033604|SUPERIORITY|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.93
71765778|NCT00955201|143033604|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at baseline.||||0.38
71765779|NCT00955201|143033604|SUPERIORITY|||||||0.55|||||||ANOVA|||Comparison across groups at 12-wks.||||0.55
71765780|NCT00955201|143033604|SUPERIORITY|||||||0.37|||||||ANOVA|||Comparison across groups at 24-wks||||0.37
71710306|NCT02691494|142937608|SUPERIORITY||LS Mean of Difference|-252.3|STANDARD_ERROR_OF_MEAN|24.53|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71710307|NCT02691494|142937608|SUPERIORITY||LS Mean of Difference|-226.6|STANDARD_ERROR_OF_MEAN|20.5|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71710308|NCT02691494|142937609|SUPERIORITY||LS Mean of Difference|-196.9|STANDARD_ERROR_OF_MEAN|16.66|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71710309|NCT02691494|142937609|SUPERIORITY||LS Mean of Difference|-186.1|STANDARD_ERROR_OF_MEAN|14.18|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71710310|NCT02691494|142937610|SUPERIORITY||Between-Group Difference (%)|19.2||||0.146|TWO_SIDED|95.0|-5.99|44.32||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||44.32|-5.99|0.146
71710311|NCT02691494|142937610|SUPERIORITY||Between-Group Difference (%)|29.2||||0.017|TWO_SIDED|95.0|7.62|50.71||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||50.71|7.62|0.017
71710312|NCT02691494|142937611|SUPERIORITY||LS Mean of Difference|-194.5|STANDARD_ERROR_OF_MEAN|20.56|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71710313|NCT02691494|142937611|SUPERIORITY||LS Mean of Difference|-125.0|STANDARD_ERROR_OF_MEAN|17.55|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71710314|NCT00637156|142937612|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.113||||1|TWO_SIDED|95.0|0.022|0.201||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.201|0.022|1.000
71710315|NCT00637156|142937612|SUPERIORITY_OR_OTHER|||||||0.993||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.993
71710316|NCT00637156|142937613|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.088||||1|TWO_SIDED|95.0|0.012|0.167||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.167|0.012|1.000
71710317|NCT00637156|142937613|SUPERIORITY_OR_OTHER|||||||0.99||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.990
71710318|NCT00637156|142937614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.05||||1|TWO_SIDED|95.0|-0.014|0.119||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.119|-0.014|1.000
71710319|NCT00637156|142937614|SUPERIORITY_OR_OTHER|||||||0.931||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.931
71738986|NCT00620113|142990732|SUPERIORITY_OR_OTHER||Difference in LS Means|2.43||||0.002|TWO_SIDED|95.0|0.99|3.88||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.||3.88|0.99|0.002
71710320|NCT00637156|142937615|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.021||||1|TWO_SIDED|95.0|-0.019|0.062||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.062|-0.019|1.000
71710321|NCT00637156|142937615|SUPERIORITY_OR_OTHER|||||||0.852||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.852
71710322|NCT00637156|142937616|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.008||||0.997|TWO_SIDED|95.0|-0.073|0.056||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.056|-0.073|0.997
71710323|NCT00637156|142937616|SUPERIORITY_OR_OTHER|||||||0.395||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.395
71710324|NCT00637156|142937617|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.024||||1|TWO_SIDED|95.0|-0.042|0.088||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.088|-0.042|1.000
71710325|NCT00637156|142937617|SUPERIORITY_OR_OTHER|||||||0.767||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.767
71710326|NCT00637156|142937618|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.024||||0.945|TWO_SIDED|95.0|-0.12|0.067||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.067|-0.120|0.945
71710327|NCT00637156|142937619|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.017||||0.997|TWO_SIDED|95.0|-0.072|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.072|0.997
71710328|NCT00637156|142937619|SUPERIORITY_OR_OTHER|||||||0.271||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.271
71710329|NCT00637156|142937620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.013||||1|TWO_SIDED|95.0|-0.013|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.040|-0.013|1.000
71710330|NCT00637156|142937620|SUPERIORITY_OR_OTHER|||||||0.859||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.||||0.859
71886707|NCT02475655|143293609|SUPERIORITY||Mean Difference (Net)|1.22||||0.32|TWO_SIDED|90.0|0.87|1.72||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 5.||1.72|0.87|0.32
71826784|NCT00383188|143158062|SUPERIORITY||LSM Difference|-9.345|STANDARD_ERROR_OF_MEAN|4.237||0.0276|TWO_SIDED|95.0|-17.66|-1.031|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-1.031|-17.66|0.0276
71886708|NCT02475655|143293609|SUPERIORITY||Mean Difference (Net)|1.03||||0.91|TWO_SIDED|90.0|0.68|1.56||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 12.||1.56|0.68|0.91
71710331|NCT00637156|142937621|SUPERIORITY_OR_OTHER||Posterior Mean Difference|0.4||||0|TWO_SIDED|95.0|0.252|0.548||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.548|0.252|0.0
71710332|NCT00637156|142937622|SUPERIORITY_OR_OTHER||Posterior Mean Difference|11.5||||0.02|TWO_SIDED|95.0|0.56|22.44|||Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||22.440|0.560|0.02
71710333|NCT00637156|142937623|SUPERIORITY_OR_OTHER||Posterior Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.258|0.058||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1- μ0 \< 0\|data) be at least 97.5%, the superiority would be claimed."||0.058|-0.258|0.892
71710334|NCT04632030|142937665|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Adjusted for age, education, and lifetime tobacco use|||3.6|.69|
71710335|NCT04632030|142937665|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|1.28|6.55|||||Adjusted for age, education, and lifetime tobacco use|||6.55|1.28|
71710336|NCT04632030|142937666|OTHER||Odds Ratio (OR)|2.88|||||TWO_SIDED|95.0|1.28|6.47|||||Adjusted for age, education, and lifetime tobacco use|||6.47|1.28|
71710337|NCT04632030|142937666|OTHER||Odds Ratio (OR)|2.87|||||TWO_SIDED|95.0|1.26|6.5|||||Adjusted for age, education, and lifetime tobacco use|||6.50|1.26|
71710338|NCT04632030|142937667|OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.59|3.86|||||Adjusted for age, education, and lifetime tobacco use|||3.86|.59|
71710339|NCT04632030|142937667|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.73|4.67|||||Adjusted for age, education, and lifetime tobacco use|||4.67|.73|
71710340|NCT04632030|142937668|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.53|2.99|||||Adjusted for age, education, and lifetime tobacco use|||2.99|.53|
71710341|NCT04632030|142937668|OTHER||Odds Ratio (OR)|2.19|||||TWO_SIDED|95.0|0.94|5.13|||||Adjusted for age, education, and lifetime tobacco use|||5.13|.94|
71710342|NCT00561821|142937706|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710343|NCT00561821|142937706|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710344|NCT00561821|142937706|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710345|NCT00561821|142937707|SUPERIORITY_OR_OTHER|||||||0.0146||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0146
71710346|NCT00561821|142937707|SUPERIORITY_OR_OTHER|||||||0.0234||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0234
71710347|NCT00561821|142937707|SUPERIORITY_OR_OTHER|||||||0.0102||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0102
71710348|NCT00561821|142937708|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71886709|NCT02475655|143293610|SUPERIORITY|||||||0.4||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5).||||0.40
71710349|NCT00561821|142937708|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71826785|NCT00383188|143158062|SUPERIORITY||LSM Difference|-12.69|STANDARD_ERROR_OF_MEAN|4.873||0.0093|TWO_SIDED|95.0|-22.25|-3.128|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||-3.128|-22.25|0.0093
71826786|NCT00383188|143158062|SUPERIORITY||LSM Difference|-9.599|STANDARD_ERROR_OF_MEAN|5.03||0.0566|TWO_SIDED|95.0|-19.47|0.271|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||0.271|-19.47|0.0566
71710350|NCT00561821|142937708|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710351|NCT00561821|142937709|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.001
71710352|NCT00561821|142937709|SUPERIORITY_OR_OTHER|||||||0.0213||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0213
71710353|NCT00561821|142937709|SUPERIORITY_OR_OTHER|||||||0.0135||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0135
71710354|NCT00561821|142937710|SUPERIORITY_OR_OTHER|||||||0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0001
71710355|NCT00561821|142937710|SUPERIORITY_OR_OTHER|||||||0.0003||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0003
71710356|NCT00561821|142937710|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710357|NCT00561821|142937711|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710358|NCT00561821|142937711|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710359|NCT00561821|142937711|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71765781|NCT00955201|143033605|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
71886710|NCT02475655|143293610|SUPERIORITY|||||||0.87||||||Not adjusted for multiple comparisons. Two-sided 10% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any post-treatment time point (ever shedding at weeks 10 or 12).||||0.87
71710360|NCT00561821|142937712|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710361|NCT00561821|142937712|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710362|NCT00561821|142937712|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71765782|NCT00955201|143033605|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
71765783|NCT00955201|143033605|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time||||1.00
71710363|NCT00561821|142937713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710364|NCT00561821|142937713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710365|NCT00561821|142937713|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710366|NCT00561821|142937714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710367|NCT00561821|142937714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710368|NCT00561821|142937714|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710369|NCT00561821|142937715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710370|NCT00561821|142937715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710371|NCT00561821|142937715|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710372|NCT00561821|142937716|SUPERIORITY_OR_OTHER|||||||0.6317||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6317
71710373|NCT00561821|142937716|SUPERIORITY_OR_OTHER|||||||0.6355||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6355
71710374|NCT00561821|142937716|SUPERIORITY_OR_OTHER|||||||0.7865||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.7865
71710375|NCT00561821|142937717|SUPERIORITY_OR_OTHER|||||||0.4033||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4033
71765784|NCT00955201|143033605|SUPERIORITY|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time.||||1.00
71765785|NCT00955201|143033605|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||Comparison across groups at baseline||||0.81
71765786|NCT00955201|143033605|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Comparison across groups at 12-wks||||0.60
71765787|NCT00955201|143033605|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||Comparison across groups at 24-wks||||0.99
71765788|NCT00955201|143033606|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
71655442|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-4.2|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-4.2|
71655443|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|1.07|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.5|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-1.5|
71655444|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-1.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.8|
71655445|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.32|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-3.9|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.9|
71655446|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.0|3.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.2|-2.0|
71655447|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.6|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.6|
71710376|NCT00561821|142937717|SUPERIORITY_OR_OTHER|||||||0.4153||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.4153
71710377|NCT00561821|142937717|SUPERIORITY_OR_OTHER|||||||0.6271||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.6271
71710378|NCT00561821|142937718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710379|NCT00561821|142937718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710380|NCT00561821|142937718|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||<0.0001
71710381|NCT00561821|142937719|SUPERIORITY_OR_OTHER|||||||0.0243||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0243
71710382|NCT00561821|142937719|SUPERIORITY_OR_OTHER|||||||0.0242||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0242
71710383|NCT00561821|142937719|SUPERIORITY_OR_OTHER|||||||0.0007||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0007
71710384|NCT00561821|142937720|SUPERIORITY_OR_OTHER|||||||0.0199||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0199
71710385|NCT00561821|142937720|SUPERIORITY_OR_OTHER|||||||0.0316||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0316
71710386|NCT00561821|142937720|SUPERIORITY_OR_OTHER|||||||0.0014||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA|||||||0.0014
71710387|NCT03443401|142937746|SUPERIORITY||Mean Difference (Net)|80.0||||0.004|TWO_SIDED|||||level of significance at \<0.05|Spearman's rho|||||||0.004
71765789|NCT00955201|143033607|SUPERIORITY|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.98
71655448|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.05|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-4.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.7|
71655449|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.3253|||TWO_SIDED|95.0|-2.2|3.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.0|-2.2|
71655450|NCT02037165|142829268|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.3254|||TWO_SIDED|95.0|-2.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.3|-2.9|
71655451|NCT02037165|142829269|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.4|1.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.4|
71655452|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.4|0.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.4|
71655453|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-4.1|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-4.1|
71710388|NCT03443401|142937747|SUPERIORITY||Mean Difference (Net)|80.0||||0.027|TWO_SIDED|||||Level of significance \<0.05|Spearman's rho|||||||0.027
71710389|NCT01557569|142937773|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.413|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||Due to skewed data, Kruskal Wallis Test was used.||||<0.05
71710390|NCT02254460|142937774|SUPERIORITY_OR_OTHER||[Treatment difference]|1.74||||0.0944|TWO_SIDED|95.0|0.9|3.34|||ANOVA||Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).|||3.34|0.90|0.0944
71710391|NCT00137449|142937775|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.0||||||95.0|31.3|68.7|||F distribution|||||68.7|31.3|
71710392|NCT00137449|142937775|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|56.7||||||95.0|37.4|74.5|||F distribution|||||74.5|37.4|
71710393|NCT00137449|142937775|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|53.3||||||95.0|40.0|66.3|||F distribution|||Null hypothesis that the true CBR \<=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% \& 90% power. If \>=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If \<= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.||66.3|40.0|
71710394|NCT00137449|142937777|SUPERIORITY_OR_OTHER||ORR rate (percentage)|10.0||||||95.0|2.1|26.5|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||26.5|2.1|
71710395|NCT00137449|142937777|SUPERIORITY_OR_OTHER||ORR rate (percentage)|16.7||||||95.0|5.6|34.7|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||34.7|5.6|
71710396|NCT00137449|142937777|SUPERIORITY_OR_OTHER||ORR rate (percentage)|13.3||||||95.0|5.9|24.6|||F distribution||PR or CR responding tumor measurements confirmed by repeat studies performed at \> 4 weeks after the criteria for response first met.|||24.6|5.9|
71710397|NCT00137449|142937779|SUPERIORITY_OR_OTHER||median|27.0||||||95.0|22.0|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.||73.1|22.0|
71765790|NCT00955201|143033607|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71655454|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
71655455|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-2.1|
71655456|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.1|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.1|
71655457|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
71655458|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.2418|||TWO_SIDED|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.9|-3.0|
71655459|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|1.2419|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
71655460|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.7|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.1|-3.7|
71655461|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.3|0.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.5|-4.3|
71655462|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.16|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-3.6|
71765791|NCT00955201|143033607|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71710398|NCT00137449|142937779|SUPERIORITY_OR_OTHER||median|35.1||||||95.0|24.4|51.6|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||51.6|24.4|
71710399|NCT00137449|142937779|SUPERIORITY_OR_OTHER||median|33.6||||||95.0|24.1|49.0|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.||49.0|24.1|
71710400|NCT00137449|142937780|SUPERIORITY_OR_OTHER||median|57.0||||||95.0|24.1|73.1|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||73.1|24.1|
71710401|NCT00137449|142937780|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
71710402|NCT00137449|142937780|SUPERIORITY_OR_OTHER||median|42.1||||||95.0|26.1|65.9|||Kaplan-Meier method|||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.||65.9|26.1|
71710403|NCT00137449|142937782|SUPERIORITY_OR_OTHER||1 year survival rate|60.0||||||95.0|40.5|75.0|||Kaplan-Meier method|||||75.0|40.5|
71710404|NCT00137449|142937782|SUPERIORITY_OR_OTHER||1 year survival rate|79.7||||||95.0|60.3|90.3|||Kaplan-Meier method|||||90.3|60.3|
71710405|NCT00137449|142937782|SUPERIORITY_OR_OTHER||1 year survival rate|69.7||||||95.0|56.3|79.7|||Kaplan-Meier method|||||79.7|56.3|
71710406|NCT01356940|142937786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.586||||0.586|TWO_SIDED||||||Mixed Models Analysis||P values above 0.05 are considered statistically not significant in this study|||||0.586
71710407|NCT04507763|142937816|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
71710408|NCT04507763|142937817|OTHER|||||||0.001|||||||Regression, Logistic|||Change from Baseline at Month 12: For Early Referral||||0.001
71710409|NCT02655601|142937871|SUPERIORITY||Hazard Ratio (HR)|0.791||||0.135|ONE_SIDED|95.0||95.0||Study was originally designed with 1 IA after approximately 42 deaths. An unplanned, 2nd IA was conducted to support a BTDR. The study was not terminated early as a result of either IAs. No further IA were conducted until the primary analysis.|Log Rank|89 study participants had passed away at the time of this analysis (41 in the RT/TMZ + BMX-001 arm and 48 in the Radiation Therapy/TMZ arm).||A 1-tailed logrank test was conducted at the 0.2 level. This test had 90% power to detect a hazard ratio of 0.63 after 84 deaths were observed among the 160 randomized patients.||95||0.135
71710410|NCT02655601|142937883|SUPERIORITY||Odds Ratio (OR)|0.45||||0.465|ONE_SIDED||||||Fisher Exact|||With 78 and 71 patients in Arms A and B, respectively, there was 80% power with a one-tailed chi-square test (α=0.05) to detect a reduction in grade 3 or 4 thrombocytopenia from 15% in Arm B (without BMX-001) to 3.7% in Arm A (with BMX-001). Given the small number of patients that experienced low platelet counts or thrombocytopenia, a one-tailed Fisher's exact test was performed instead.||||0.465
71710411|NCT02655601|142937884|SUPERIORITY||Hazard Ratio (HR)|0.978||||0.911|ONE_SIDED||||||Log Rank|||A 1-tailed logrank test was conducted at the 0.2 level.||||0.911
71710412|NCT02655601|142937885|SUPERIORITY|||||||0.401|||||||Chi-squared, Corrected|A continuity adjusted Chi-Squared test was performed.||||||0.401
71710413|NCT01603368|142937910|OTHER|Student's t-test|||||=|0.001|||||||t-test, 2 sided|||||||=0.001
71710414|NCT01251757|142937930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||<|0.001|TWO_SIDED|95.0|0.011|0.034|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.034|0.011|<.001
71710415|NCT01251757|142937930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||<|0.001|TWO_SIDED|95.0|0.019|0.042|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.042|0.019|<.001
71710416|NCT01251757|142937931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.022|TWO_SIDED|95.0|0.002|0.029|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.029|0.002|0.022
71710417|NCT01251757|142937931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|||<|0.001|TWO_SIDED|95.0|0.023|0.05|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||0.050|0.023|<.001
71710418|NCT01251757|142937932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.002|TWO_SIDED|95.0|1.05|1.24||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.24|1.05|0.002
71765792|NCT00955201|143033607|SUPERIORITY|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.72
71886711|NCT02475655|143293614|SUPERIORITY||Mean Difference (Net)|0.53||||0.4|TWO_SIDED|90.0|0.15|1.88||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 5.||1.88|0.15|0.40
71765793|NCT00955201|143033607|SUPERIORITY|||||||0.62|||||||ANOVA|||Comparison across groups at baseline.||||0.62
71765794|NCT00955201|143033607|SUPERIORITY|||||||0.33|||||||ANOVA|||Comparison across groups at 12 wks.||||0.33
71655463|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.3|
71655464|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-3.1|1.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-3.1|
71655465|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.0|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-2.0|
71655466|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-2.3|
71655467|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|1.2343|||TWO_SIDED|95.0|-4.1|0.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-4.1|
71655468|NCT02037165|142829269|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|1.2344|||TWO_SIDED|95.0|-3.6|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.6|
71655469|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.5|3.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-1.5|
71765795|NCT00955201|143033607|SUPERIORITY|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.||||0.38
71765796|NCT00955201|143033608|SUPERIORITY|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.88
71765797|NCT00955201|143033608|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71765798|NCT00955201|143033608|SUPERIORITY|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||1.00
71886712|NCT02475655|143293614|SUPERIORITY||Mean Difference (Net)|0.92||||0.93|TWO_SIDED|90.0|0.2|4.34||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 12.||4.34|0.20|0.93
71826787|NCT00383188|143158062|SUPERIORITY||LSM Difference|0.803|STANDARD_ERROR_OF_MEAN|4.366||0.854|TWO_SIDED|95.0|-7.764|9.37|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||9.370|-7.764|0.8540
71826788|NCT00383188|143158062|SUPERIORITY||LSM Difference|-2.364|STANDARD_ERROR_OF_MEAN|4.237||0.577|TWO_SIDED|95.0|-10.68|5.95|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||5.950|-10.68|0.5770
71826789|NCT00383188|143158062|SUPERIORITY||LSM Difference|-6.33|STANDARD_ERROR_OF_MEAN|4.873||0.1942|TWO_SIDED|95.0|-15.89|3.232|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||3.232|-15.89|0.1942
71826790|NCT00383188|143158062|SUPERIORITY||LSM Difference|1.494|STANDARD_ERROR_OF_MEAN|5.03||0.7665|TWO_SIDED|95.0|-8.376|11.364|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.364|-8.376|0.7665
71655470|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
71655471|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|2.06|STANDARD_ERROR_OF_MEAN|0.1752|||TWO_SIDED|95.0|-0.2|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-0.2|
71765799|NCT00955201|143033608|SUPERIORITY|||||||0.76||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.||||0.76
71655472|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-1.0|3.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.6|-1.0|
71655473|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.175|||TWO_SIDED|95.0|-1.2|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.4|-1.2|
71765800|NCT00955201|143033608|SUPERIORITY|||||||0.82|||||||ANOVA|||Comparison across groups at baseline.||||0.82
71765801|NCT00955201|143033608|SUPERIORITY|||||||0.53|||||||ANOVA|||Comparison across groups at 12 wks.||||0.53
71765802|NCT00955201|143033608|SUPERIORITY|||||||0.68|||||||ANOVA|||Comparison across groups at 24 wks.||||0.68
71765803|NCT00955201|143033609|SUPERIORITY|||||||0.7|||||||ANOVA|||Comparison across groups at baseline.||||0.70
71765804|NCT00955201|143033611|SUPERIORITY|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.||||0.59
71765805|NCT00955201|143033612|SUPERIORITY|||||||0.45|||||||ANOVA|||Comparison across groups at baseline.||||0.45
71826791|NCT00383188|143158062|SUPERIORITY||LSM Difference|3.291|STANDARD_ERROR_OF_MEAN|4.366||0.4512|TWO_SIDED|95.0|-5.276|11.858|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.858|-5.276|0.4512
71826792|NCT00383188|143158062|SUPERIORITY||LSM Difference|-0.095|STANDARD_ERROR_OF_MEAN|4.237||0.9822|TWO_SIDED|95.0|-8.409|8.22|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||8.220|-8.409|0.9822
71826793|NCT00383188|143158062|SUPERIORITY||LSM Difference|-5.148|STANDARD_ERROR_OF_MEAN|4.873||0.291|TWO_SIDED|95.0|-14.71|4.414|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||4.414|-14.71|0.2910
71886713|NCT03545906|143293616|SUPERIORITY||Mean Difference (Net)|1.0||||0.075|TWO_SIDED||||||t-test, 2 sided|||||||.075
71886714|NCT03545906|143293617|SUPERIORITY||Mean Difference (Net)|1.3||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||.018
71886715|NCT03545906|143293618|SUPERIORITY||Mean Difference (Net)|1.2||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||.039
71886716|NCT03545906|143293619|SUPERIORITY||Mean Difference (Net)|0.7||||0.265|TWO_SIDED||||||t-test, 2 sided|||||||.265
71655474|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.57|STANDARD_ERROR_OF_MEAN|1.1751|||TWO_SIDED|95.0|-2.9|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.9|
71655475|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.43|STANDARD_ERROR_OF_MEAN|1.1752|||TWO_SIDED|95.0|-3.7|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.9|-3.7|
71655476|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.1755|||TWO_SIDED|95.0|-2.1|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-2.1|
71655477|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.43|STANDARD_ERROR_OF_MEAN|1.1758|||TWO_SIDED|95.0|-1.9|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.7|-1.9|
71655478|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.68|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-4.0|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-4.0|
71655479|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.8|-1.8|
71655480|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|1.89|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-0.4|4.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.2|-0.4|
71655481|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|1.25|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.0|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-1.0|
71655482|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-1.6|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.6|
71765806|NCT00955201|143033613|SUPERIORITY|||||||0.04|||||||ANOVA|||Comparison across groups at baseline.||||0.04
71765807|NCT00955201|143033614|SUPERIORITY|||||||0.77|||||||ANOVA|||Comparison across groups at baseline.||||0.77
71765808|NCT00955201|143033615|SUPERIORITY|||||||0.12|||||||ANOVA|||Comparison across groups at baseline.||||0.12
71765809|NCT00955201|143033616|SUPERIORITY|||||||0.42|||||||ANOVA|||Comparison across groups at baseline.||||0.42
71886717|NCT00353418|143293620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6119||95.0|0.68|1.93|||Cochran-Mantel-Haenszel|||"Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83"||1.93|0.68|0.6119
71710419|NCT01251757|142937932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16|||<|0.001|TWO_SIDED|95.0|1.06|1.26||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.26|1.06|<0.001
71710420|NCT01251757|142937933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.014|TWO_SIDED|95.0|1.02|1.23||adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.23|1.02|0.014
71710421|NCT01251757|142937933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21|||<|0.001|TWO_SIDED|95.0|1.1|1.32||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.||1.32|1.10|<0.001
71710422|NCT01251757|142937934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.041|TWO_SIDED|95.0|-1.0|0.0||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||0.0|-1.0|.041
71710423|NCT01251757|142937934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.5|0.5||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||.5|-.5|.93
71710424|NCT01251757|142937935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.404|TWO_SIDED|95.0|0.93|1.19||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.19|0.93|.404
71710425|NCT01251757|142937935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.54|TWO_SIDED|95.0|0.85|1.09||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.||1.09|.85|.54
71710426|NCT01251757|142937936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.38|TWO_SIDED|95.0|-1.8|0.7||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.||0.7|-1.8|.38
71738987|NCT00620113|142990733|SUPERIORITY_OR_OTHER||Difference in LS Means|-50.64|||<|0.001|TWO_SIDED|95.0|-66.43|-34.84||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-34.84|-66.43|<0.001
71765810|NCT00955201|143033617|SUPERIORITY|||||||0.79|||||||ANOVA|||Comparison across groups at baseline.||||0.79
71655483|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference of 200 mg BI mi|-0.43|STANDARD_ERROR_OF_MEAN|1.1564|||TWO_SIDED|95.0|-2.7|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.7|
71765811|NCT03032380|143033618|NON_INFERIORITY|The study hypothesis was that the all-cause mortality rate at Day 14 in participants who received cefiderocol would be non-inferior to that in participants who received high-dose meropenem. The margin of non-inferiority was 12.5%. Non-inferiority was concluded if the upper bound of the 2-sided 95% confidence interval for the difference in mortality at Day 14 between the 2 treatment groups (cefiderocol - meropenem) was smaller than 12.5%.|Treatment Difference|0.8||||0.002|TWO_SIDED|95.0|-6.6|8.2|||Cochran-Mantel-Haenszel||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 14 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||8.2|-6.6|0.0020
71765812|NCT03032380|143033619|SUPERIORITY||Treatment Difference|-1.4|||||TWO_SIDED|95.0|-13.5|10.7|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the eradication rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.7|-13.5|
71765813|NCT03032380|143033620|SUPERIORITY||Treatment Difference|-2.0|||||TWO_SIDED|95.0|-12.5|8.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.5|-12.5|
71655484|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.1565|||TWO_SIDED|95.0|-3.0|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-3.0|
71655485|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|1.1566|||TWO_SIDED|95.0|-2.2|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-2.2|
71655486|NCT02037165|142829270|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1567|||TWO_SIDED|95.0|-3.0|1.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.6|-3.0|
71655487|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.7|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.7|-2.7|
71655488|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.2|
71765814|NCT03032380|143033621|OTHER||Treatment Difference|-0.3|||||TWO_SIDED|95.0|-8.8|8.2|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||8.2|-8.8|
71886718|NCT03244033|143293679|SUPERIORITY||Odds Ratio (OR)|0.97||||0.91|TWO_SIDED|96.0|0.57|1.64|||Mixed Models Analysis|Adjusted for site (p\<.001) and for whether physician contextualized plan (AOR 2.14, p=.001), and random effects of physician and patient.||Logistic mixed effects regression modeling likelihood of red flag improved/resolved (vs. not) during outcome period with fixed effects of intervention, site, and whether contextual factor was incorporated into care plan, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||1.64|.57|.91
71765815|NCT03032380|143033622|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-12.8|5.1|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||5.1|-12.8|
71655489|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.7|
71655490|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
71655491|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
71655492|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|1.1236|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
71655493|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.1238|||TWO_SIDED|95.0|-3.7|0.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.7|-3.7|
71655494|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.124|||TWO_SIDED|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.3|
71655495|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.1242|||TWO_SIDED|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-2.3|
71655496|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-2.5|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-2.5|
71765816|NCT03032380|143033623|OTHER||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-10.9|10.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||10.8|-10.9|
71765817|NCT03032380|143033624|OTHER||Treatment Difference|-12.4|||||TWO_SIDED|95.0|-24.4|-0.5|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||-0.5|-24.4|
71765818|NCT03032380|143033625|OTHER||Treatment Difference|-3.8|||||TWO_SIDED|95.0|-15.5|7.9|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||7.9|-15.5|
71765819|NCT03032380|143033626|OTHER||Treatment Difference|3.9|||||TWO_SIDED|95.0|-7.9|15.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the cure rate calculated using Cochran-Mantel-Haenszel weights based on infection diagnosis (HABP/VABP/HCABP), and APACHE II score (≤ 15 and ≥ 16).|||15.8|-7.9|
71765820|NCT03032380|143033627|OTHER||Treatment Difference|0.5|||||TWO_SIDED|95.0|-8.7|9.8|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at Day 28 based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||9.8|-8.7|
71765821|NCT03032380|143033628|OTHER||Treatment Difference|3.6|||||TWO_SIDED|95.0|-6.3|13.4|||||Treatment difference (cefiderocol - meropenem) was the adjusted estimate of the difference in the ACM rate at EOS based on Cochran-Mantel Haenszel weights using APACHE II score (≤ 15 and ≥ 16) as the stratification factor.|||13.4|-6.3|
71765822|NCT03032380|143033629|SUPERIORITY|||||||0.9382|||||||t-test, 2 sided|||Comparison of Hospitalization time at test of cure||||0.9382
71765823|NCT03032380|143033629|SUPERIORITY|||||||0.6552|||||||t-test, 2 sided|||Comparison of hospitalization time at follow-up||||0.6552
71826794|NCT00383188|143158062|SUPERIORITY||LSM Difference|2.828|STANDARD_ERROR_OF_MEAN|5.03||0.5741|TWO_SIDED|95.0|-7.042|12.698|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||12.698|-7.042|0.5741
71826795|NCT00383188|143158062|SUPERIORITY||LSM Difference|3.107|STANDARD_ERROR_OF_MEAN|4.366||0.4768|TWO_SIDED|95.0|-5.46|11.674|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.674|-5.460|0.4768
71826796|NCT00383188|143158062|SUPERIORITY||LSM Difference|-2.256|STANDARD_ERROR_OF_MEAN|4.237||0.5945|TWO_SIDED|95.0|-10.57|6.058|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||6.058|-10.57|0.5945
71886719|NCT03244033|143293680|SUPERIORITY||Odds Ratio (OR)|2.09||||0.02|TWO_SIDED|95.0|1.13|3.86|||Mixed Models Analysis|Adjusted for site, source of red flag, visible/concealed recorder, and random effects of physician and patient.|OR\>1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider probing red flag (vs. not) during visit with fixed effects of intervention, site, \\whether red flag was select on pre-visit questionnaire, and whether audiorecorder was visible to provider, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||3.86|1.13|0.02
71886720|NCT03244033|143293681|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.32|5.41|||Mixed Models Analysis|Adjusted for site, source of factor, recorder visible/concealed, and random effects of physician and patient.|OR \> 1 indicates greater likelihood in intervention group vs. control.|Logistic mixed effects regression modeling likelihood of provider incorporating contextual factor into care plan (vs. not) at visit with fixed effects of intervention, site, whether red flag was select on pre-visit questionnaire, whether audiorecorder was visible to provider, whether factor was identified by provider probe, whether factor was revealed by patient, and random effects of patient and provider. Red flags may be clustered in patients; patients are clustered in providers.||5.41|1.32|.006
71765824|NCT04093024|143033668|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9858|TWO_SIDED|95.0|-0.8|0.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||0.8|-0.8|0.9858
71886721|NCT03021642|143293694|SUPERIORITY_OR_OTHER_LEGACY||Geometric Least square (LS) mean ratio|98.68|||||TWO_SIDED|90.0|93.67|103.96||||||||103.96|93.67|
71826797|NCT00383188|143158062|SUPERIORITY||LSM Difference|0.609|STANDARD_ERROR_OF_MEAN|4.873||0.9006|TWO_SIDED|95.0|-8.953|10.171|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||10.171|-8.953|0.9006
71886722|NCT03021642|143293695|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|95.71|||||TWO_SIDED|90.0|88.43|103.59||||||||103.59|88.43|
71886723|NCT03021642|143293696|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|96.88|||||TWO_SIDED|90.0|90.8|103.36||||||||103.36|90.8|
71826798|NCT00383188|143158062|SUPERIORITY||LSM Difference|9.224|STANDARD_ERROR_OF_MEAN|5.03||0.067|TWO_SIDED|95.0|-0.646|19.094|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||19.094|-0.646|0.0670
71826799|NCT00383188|143158062|SUPERIORITY||LSM Difference|8.261|STANDARD_ERROR_OF_MEAN|4.647||0.0757|TWO_SIDED|95.0|-0.857|17.379|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||17.379|-0.857|0.0757
71826800|NCT00383188|143158062|SUPERIORITY||LSM Difference|5.357|STANDARD_ERROR_OF_MEAN|4.427||0.2265|TWO_SIDED|95.0|-3.329|14.043|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||14.043|-3.329|0.2265
71765825|NCT04093024|143033669|OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9769|TWO_SIDED|95.0|-1.7|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||1.6|-1.7|0.9769
71710427|NCT01251757|142937936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.019|TWO_SIDED|95.0|-2.7|-0.2||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||-0.2|-2.7|.019
71710428|NCT01251757|142937937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.59|TWO_SIDED|95.0|0.93|1.13||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.13|0.93|.59
71710429|NCT01251757|142937937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.058|TWO_SIDED|95.0|1.0|1.22||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.||1.22|1.00|.058
71710430|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.108|||<|0.001|TWO_SIDED|95.0|0.055|0.161|||Mixed Models Analysis|||||0.161|0.055|<0.001
71710431|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.117|||<|0.001|TWO_SIDED|95.0|0.064|0.171|||Mixed Models Analysis|||||0.171|0.064|<0.001
71710432|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.162|||<|0.001|TWO_SIDED|95.0|0.107|0.216|||Mixed Models Analysis|||||0.216|0.107|<0.001
71710433|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.122|||<|0.001|TWO_SIDED|95.0|0.069|0.175|||Mixed Models Analysis|||||0.175|0.069|<0.001
71765826|NCT04093024|143033671|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.4||0.4442|TWO_SIDED|95.0|-1.8|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||4.0|-1.8|0.4442
71765827|NCT04093024|143033674|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.882|TWO_SIDED|95.0|-1.5|1.8|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.8|-1.5|0.8820
71765828|NCT04093024|143033675|OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.9652|TWO_SIDED|95.0|-3.2|3.3|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.3|-3.2|0.9652
71765829|NCT04093024|143033676|OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1||0.4084|TWO_SIDED|95.0|-9.3|4.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||4.0|-9.3|0.4084
71765830|NCT04093024|143033677|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9928|TWO_SIDED|95.0|-1.6|1.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||1.6|-1.6|0.9928
71765831|NCT04093024|143033678|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.4||0.6366|TWO_SIDED|95.0|-2.3|3.6|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||3.6|-2.3|0.6366
71765832|NCT04093024|143033679|OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.3||0.8823|TWO_SIDED|95.0|-5.2|5.9|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|No formal hypotheses were tested||5.9|-5.2|0.8823
71710434|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.009||||0.556|TWO_SIDED|95.0|-0.021|0.039|||Mixed Models Analysis|||||0.039|-0.021|0.556
71710435|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.053||||0.001|TWO_SIDED|95.0|0.021|0.085|||Mixed Models Analysis|||||0.085|0.021|0.001
71710436|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.014||||0.365|TWO_SIDED|95.0|-0.016|0.044|||Mixed Models Analysis|||||0.044|-0.016|0.365
71710437|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.044||||0.006|TWO_SIDED|95.0|0.013|0.076|||Mixed Models Analysis|||||0.076|0.013|0.006
71710438|NCT02796651|142937938|SUPERIORITY||LSMean difference|0.005||||0.756|TWO_SIDED|95.0|-0.026|0.036|||Mixed Models Analysis|||||0.036|-0.026|0.756
71710439|NCT02796651|142937938|SUPERIORITY||LSMean difference|-0.039||||0.014|TWO_SIDED|95.0|-0.071|-0.008|||Mixed Models Analysis|||||-0.008|-0.071|0.014
71655497|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-4.5|-0.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.2|-4.5|
71655498|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.39|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.6|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.6|
71655499|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.38|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.5|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.8|-3.5|
71655500|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15|STANDARD_ERROR_OF_MEAN|1.0983|||TWO_SIDED|95.0|-3.3|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.0|-3.3|
71655501|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-2.8|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.5|-2.8|
71655502|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.53|STANDARD_ERROR_OF_MEAN|1.0984|||TWO_SIDED|95.0|-3.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.6|-3.7|
71655503|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.0985|||TWO_SIDED|95.0|-3.1|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.2|-3.1|
71655504|NCT02037165|142829271|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.76|STANDARD_ERROR_OF_MEAN|1.0986|||TWO_SIDED|95.0|-1.4|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-1.4|
71765833|NCT04093024|143033680|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.2052|STANDARD_ERROR_OF_MEAN|2.2491||0.5962|TWO_SIDED|95.0|-3.3966|5.807|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.8070|-3.3966|0.5962
71765834|NCT04093024|143033681|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.7733|STANDARD_ERROR_OF_MEAN|3.1424||0.5776|TWO_SIDED|95.0|-4.7015|8.2481|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.2481|-4.7015|0.5776
71826801|NCT00383188|143158062|SUPERIORITY||LSM Difference|1.642|STANDARD_ERROR_OF_MEAN|5.178||0.7512|TWO_SIDED|95.0|-8.517|11.801|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||11.801|-8.517|0.7512
71710440|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.13|||<|0.001|TWO_SIDED|95.0|0.091|0.169|||Mixed Models Analysis|||||0.169|0.091|<0.001
71710441|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.206|||Mixed Models Analysis|||||0.206|0.128|<0.001
71710442|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.224|||<|0.001|TWO_SIDED|95.0|0.184|0.263|||Mixed Models Analysis|||||0.263|0.184|<0.001
71710443|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.176|0.253|||Mixed Models Analysis|||||0.253|0.176|<0.001
71710444|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.265|||<|0.001|TWO_SIDED|95.0|0.226|0.304|||Mixed Models Analysis|||||0.304|0.226|<0.001
71710445|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.037||||0.004|TWO_SIDED|95.0|0.012|0.062|||Mixed Models Analysis|||||0.062|0.012|0.004
71710446|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.094|||<|0.001|TWO_SIDED|95.0|0.068|0.119|||Mixed Models Analysis|||||0.119|0.068|<0.001
71826802|NCT00383188|143158062|SUPERIORITY||LSM Difference|2.888|STANDARD_ERROR_OF_MEAN|5.323||0.5876|TWO_SIDED|95.0|-7.557|13.332|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline C-Reactive Protein as the covariate and participant as a random effect.||13.332|-7.557|0.5876
71710447|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.059|0.11|||Mixed Models Analysis|||||0.110|0.059|<0.001
71710448|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.135|||<|0.001|TWO_SIDED|95.0|0.109|0.161|||Mixed Models Analysis|||||0.161|0.109|<0.001
71710449|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.057|||<|0.001|TWO_SIDED|95.0|0.031|0.082|||Mixed Models Analysis|||||0.082|0.031|<0.001
71710450|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.047|||<|0.001|TWO_SIDED|95.0|0.023|0.071|||Mixed Models Analysis|||||0.071|0.023|<0.001
71710451|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.073|0.123|||Mixed Models Analysis|||||0.123|0.073|<0.001
71710452|NCT02796651|142937939|SUPERIORITY||LSMean difference|-0.009||||0.469|TWO_SIDED|95.0|-0.035|0.016|||Mixed Models Analysis|||||0.016|-0.035|0.469
71710453|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.041||||0.002|TWO_SIDED|95.0|0.015|0.068|||Mixed Models Analysis|||||0.068|0.015|0.002
71710454|NCT02796651|142937939|SUPERIORITY||LSMean difference|0.051|||<|0.001|TWO_SIDED|95.0|0.025|0.076|||Mixed Models Analysis|||||0.076|0.025|<0.001
71710455|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.159|||<|0.001|TWO_SIDED|95.0|0.105|0.213|||Mixed Models Analysis|||||0.213|0.105|<0.001
71710456|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.17|||<|0.001|TWO_SIDED|95.0|0.116|0.224|||Mixed Models Analysis|||||0.224|0.116|<0.001
71710457|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.219|||<|0.001|TWO_SIDED|95.0|0.163|0.274|||Mixed Models Analysis|||||0.274|0.163|<0.001
71710458|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.179|||<|0.001|TWO_SIDED|95.0|0.125|0.233|||Mixed Models Analysis|||||0.233|0.125|<0.001
71710459|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.011||||0.488|TWO_SIDED|95.0|-0.02|0.042|||Mixed Models Analysis|||||0.042|-0.020|0.488
71826803|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.269|STANDARD_ERROR_OF_MEAN|0.188||0.154|TWO_SIDED|95.0|-0.638|0.101|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.101|-0.638|0.1540
71886724|NCT03021642|143293697|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.8981|TWO_SIDED|90.0|-1.0|1.025|||Wilcoxon signed-rank test|||||1.025|-1.000|0.8981
71710460|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.06|||<|0.001|TWO_SIDED|95.0|0.027|0.092|||Mixed Models Analysis|||||0.092|0.027|<0.001
71710461|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.02||||0.206|TWO_SIDED|95.0|-0.011|0.051|||Mixed Models Analysis|||||0.051|-0.011|0.206
71710462|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.049||||0.004|TWO_SIDED|95.0|0.016|0.081|||Mixed Models Analysis|||||0.081|0.016|0.004
71710463|NCT02796651|142937940|SUPERIORITY||LSMean difference|0.009||||0.567|TWO_SIDED|95.0|-0.022|0.041|||Mixed Models Analysis|||||0.041|-0.022|0.567
71710464|NCT02796651|142937940|SUPERIORITY||LSMean difference|-0.039||||0.017|TWO_SIDED|95.0|-0.072|-0.007|||Mixed Models Analysis|||||-0.007|-0.072|0.017
71710465|NCT02796651|142937941|SUPERIORITY||LSMean difference|0.075||||0.027|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||||0.141|0.008|0.027
71710466|NCT02796651|142937941|SUPERIORITY||LSMean difference|0.065||||0.054|TWO_SIDED|95.0|-0.001|0.131|||Mixed Models Analysis|||||0.131|-0.001|0.054
71710467|NCT02796651|142937941|SUPERIORITY||LSMean difference|0.1||||0.004|TWO_SIDED|95.0|0.032|0.168|||Mixed Models Analysis|||||0.168|0.032|0.004
71710468|NCT02796651|142937941|SUPERIORITY||LSMean difference|0.059||||0.075|TWO_SIDED|95.0|-0.006|0.123|||Mixed Models Analysis|||||0.123|-0.006|0.075
71710469|NCT02796651|142937941|SUPERIORITY||LSMean difference|-0.01||||0.615|TWO_SIDED|95.0|-0.048|0.028|||Mixed Models Analysis|||||0.028|-0.048|0.615
71710470|NCT02796651|142937941|SUPERIORITY||LSMean difference|0.025||||0.209|TWO_SIDED|95.0|-0.014|0.065|||Mixed Models Analysis|||||0.065|-0.014|0.209
71710471|NCT02796651|142937941|SUPERIORITY||LSMean difference|-0.016||||0.403|TWO_SIDED|95.0|-0.053|0.022|||Mixed Models Analysis|||||0.022|-0.053|0.403
71710472|NCT02796651|142937941|SUPERIORITY||LSMean difference|0.035||||0.074|TWO_SIDED|95.0|-0.003|0.074|||Mixed Models Analysis|||||0.074|-0.003|0.074
71710473|NCT02796651|142937941|SUPERIORITY||LSMean difference|-0.006||||0.75|TWO_SIDED|95.0|-0.045|0.032|||Mixed Models Analysis|||||0.032|-0.045|0.750
71710474|NCT02796651|142937941|SUPERIORITY||LSMean difference|-0.041||||0.035|TWO_SIDED|95.0|-0.08|-0.003|||Mixed Models Analysis|||||-0.003|-0.080|0.035
71710475|NCT05430919|142937943|SUPERIORITY||Least Squares (LS) Mean Difference|-2.31|||<|0.0001|TWO_SIDED|95.0|-3.229|-1.385|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-1.385|-3.229|<0.0001
71710476|NCT05430919|142937944|SUPERIORITY||LS Mean Difference|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.634|-1.658|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-1.658|-3.634|<0.0001
71710477|NCT05430919|142937944|SUPERIORITY||LS Mean Difference|-1.51||||0.0023|TWO_SIDED|95.0|-2.478|-0.539|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-0.539|-2.478|0.0023
71710478|NCT05430919|142937960|SUPERIORITY||LS Mean Difference|-63.18|||<|0.0001|TWO_SIDED|95.0|-73.411|-52.95|||ANCOVA||REGN5713-5714-5715 900 mg vs. Placebo, Day 29|||-52.950|-73.411|<0.0001
71710479|NCT05430919|142937960|SUPERIORITY||LS Mean Difference|-56.01|||<|0.0001|TWO_SIDED|95.0|-66.806|-45.204|||ANCOVA||REGN5713-5715 600 mg vs. Placebo, Day 29|||-45.204|-66.806|<0.0001
71710480|NCT05430919|142937960|SUPERIORITY||LS Mean Difference|-34.82|||<|0.0001|TWO_SIDED|95.0|-45.304|-24.343|||ANCOVA||REGN5715 300 mg vs. Placebo, Day 29|||-24.343|-45.304|<0.0001
71710481|NCT01469156|142937999|OTHER|Visually significant ocular or systemic AEs were predominantly mild or moderate. No significant safety signals were observed in either group.High- and standard-dose ranibizumab were generally well tolerated without evidence of ocular or systemic severe adverse events, including arterial thromboembolic events.|data survey|28.0||||0.05|TWO_SIDED|95.0|0.0|28.0||28 ocular and non-ocular adverse events collected, in mild to moderate nature|t-test, 2 sided|||Purpose was to determine safety and efficacy of intravitreal high-dose ranibizumab in the treatment of active PCV.|Visually significant ocular or systemic AEs that were either reported by subjects or identified by imaging and/or ocular exam|28|0|0.05
71710482|NCT03926247|142938086|OTHER|Within-group longitudinal analysis (no comparison groups)|LSM Final Difference|-0.044|STANDARD_ERROR_OF_MEAN|0.019|=|0.019|TWO_SIDED|95.0|-0.087|-0.008|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' depression/anxiety symptoms would decrease overtime.||-0.008|-0.087|=0.019
71710483|NCT03926247|142938087|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.643|=|0.168|TWO_SIDED|95.0|-2.161|0.372|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' PTSD symptoms would decrease overtime.||0.372|-2.161|=0.168
71710484|NCT03926247|142938088|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.035|=|0.051|TWO_SIDED|95.0|-0.14|0.0|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' stress would decrease overtime.||-0.000|-0.140|=0.051
71710485|NCT03926247|142938089|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.029|=|0.211|TWO_SIDED|95.0|-0.106|0.023|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' social support would increase overtime.||0.023|-0.106|=0.211
71765835|NCT04093024|143033682|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-0.134|STANDARD_ERROR_OF_MEAN|4.316||0.9755|TWO_SIDED|95.0|-8.975|8.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||8.707|-8.975|0.9755
71765836|NCT04093024|143033683|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|3.453|STANDARD_ERROR_OF_MEAN|5.225||0.514|TWO_SIDED|95.0|-7.25|14.157|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||14.157|-7.250|0.5140
71765837|NCT04093024|143033684|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|3.358||0.7613|TWO_SIDED|95.0|-5.848|7.908|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||7.908|-5.848|0.7613
71765838|NCT04093024|143033685|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|5.049||0.9468|TWO_SIDED|95.0|-10.026|10.707|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||10.707|-10.026|0.9468
71710486|NCT03926247|142938090|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.053|=|0.074|TWO_SIDED|95.0|-0.008|0.201|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' access to resources would increase overtime.||0.201|-0.008|=0.074
71765839|NCT04093024|143033686|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.33||0.0908|TWO_SIDED|95.0|-0.39|5.02|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.02|-0.39|0.0908
71765840|NCT04093024|143033687|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|2.28|STANDARD_ERROR_OF_MEAN|1.39||0.1222|TWO_SIDED|95.0|-0.69|5.25|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||5.25|-0.69|0.1222
71886725|NCT02474082|143293711|SUPERIORITY||Odds Ratio (OR)|16.61|||<|0.0001|TWO_SIDED|95.0|7.79|35.4|||Regression, Logistic|||||35.40|7.79|<.0001
71710487|NCT03926247|142938091|OTHER|Within-group longitudinal analysis (no comparison groups)=|Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.061|=|0.089|TWO_SIDED|95.0|-0.257|0.017|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' difficulty accessing resources would decrease overtime.||0.017|-0.257|=0.089
71710488|NCT03926247|142938092|OTHER|Within-group longitudinal analysis (no comparison groups)|Mean Difference (Final Values)|-0.216|STANDARD_ERROR_OF_MEAN|0.124|=|0.086|TWO_SIDED|95.0|-0.461|0.03|||Mixed Models Analysis|||Analyses were conducted using a mixed effects linear model to calculate least square means across the 4 timepoints. This was a longitudinal within-group analysis with 4 timepoints of data nested within 56 individuals. Our hypothesis was that participants' quality of life would increase overtime.||0.030|-0.461|=0.086
71710489|NCT00773461|142938109|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71710490|NCT00773461|142938109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||ITT Population (Sensitivity)|Cochran-Mantel-Haenszel|||||||<0.0001
71710491|NCT00773461|142938110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Comparison of ACR 50 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||<0.0001
71710492|NCT00773461|142938110|SUPERIORITY_OR_OTHER|||||||0.0345||||||Comparison of ACR 70 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel|||||||0.0345
71710493|NCT00773461|142938112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||<|0.0001|TWO_SIDED|95.0|-6.6|-2.8||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Swollen Joint Count||-2.8|-6.6|<0.0001
71710494|NCT00773461|142938112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.3|-6.1||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count||-6.1|-11.3|<0.0001
71710495|NCT00773461|142938113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.3|-12.9|||ANCOVA|||||-12.9|-25.3|<0.0001
71710496|NCT00773461|142938114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.0001|TWO_SIDED|95.0|-24.5|-14.0|||ANCOVA|||||-14.0|-24.5|<0.0001
71710497|NCT00773461|142938115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|||<|0.0001|TWO_SIDED|95.0|-25.2|-12.7|||ANCOVA|||||-12.7|-25.2|<0.0001
71710498|NCT00773461|142938116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7384|||<|0.0001|TWO_SIDED|95.0|-2.1464|-1.3303|||ANCOVA|||||-1.3303|-2.1464|<0.0001
71710499|NCT00773461|142938117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.2|||<|0.0001|TWO_SIDED|95.0|-44.7|-33.7|||ANCOVA|||||-33.7|-44.7|<.0001
71710500|NCT00773461|142938119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0003|TWO_SIDED|95.0|1.8|5.9|||ANCOVA|||||5.9|1.8|0.0003
71710501|NCT00773461|142938120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.3||||0.0599|TWO_SIDED|95.0|-139.5|2.9|||ANCOVA|||||2.9|-139.5|0.0599
71710502|NCT00773461|142938121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.956|||<|0.0001|TWO_SIDED|95.0|9.125|16.786|||ANCOVA|||||16.786|9.125|<0.0001
71710503|NCT00773461|142938122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||ANCOVA|||||-0.28|-0.56|<0.0001
71886726|NCT00523991|143293743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.27||"There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.~Mean Difference (Final Values) means difference in LS-Means"|ANCOVA|The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.||||0.27|0.18|<0.001
71710504|NCT00322218|142938131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8578|||||||Stratified Log-Rank Test|||||||0.8578
71710505|NCT05472870|142938133|SUPERIORITY|One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS. A P value \<0.05 was considered statistically significant for all analyses.|||||<|0.001||||||Bonferroni correction was used to adjust P values in post hoc analyses.|ANOVA|||All clinical behavioral data analysis was performed using Statistical Product and Service Solutions (SPSS) software (version 25.0). A P value \<0.05 was considered statistically significant for all analyses. One-way ANOVA with repeated measures was used to examine differences in the effects of cTMS on the SRS.||||<0.001
71710506|NCT01385995|142938143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.57|TWO_SIDED|95.0|0.52|3.24|||Generalized Estimating Equation|Controlled for period and baseline 2 hour OGTT glucose level.||Based on an intent to treat approach a Generalized Estimating Equation (GEE) was used to estimate the effect of therapy (CPAP or Sham) on the odds of normalization of Impaired Glucose Tolerance (IGT). This model provides an estimate of the odds ratio of normalizing the 2-hour oral glucose tolerance test (OGTT) with CPAP compared with Sham-CPAP.||3.24|0.52|0.57
71710507|NCT01385995|142938144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.38|TWO_SIDED|95.0|-1.2|3.0|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP.||3.0|-1.2|0.38
71765841|NCT04093024|143033688|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|28.2||0.8012|TWO_SIDED|95.0|-50.7|65.0|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||65.0|-50.7|0.8012
71710508|NCT01385995|142938144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.11|TWO_SIDED|95.0|-16.3|1.7|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham.||1.7|-16.3|0.11
71710509|NCT01385995|142938144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.86|TWO_SIDED|95.0|-3.3|2.7|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25.||2.7|-3.3|0.86
71886727|NCT00523991|143293747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.18|0.09|<0.001
71826804|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.182||0.0011|TWO_SIDED|95.0|-0.958|-0.242|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.242|-0.958|0.0011
71826805|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.691|STANDARD_ERROR_OF_MEAN|0.211||0.0011|TWO_SIDED|95.0|-1.105|-0.277|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.277|-1.105|0.0011
71710510|NCT01385995|142938144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6||||0.08|TWO_SIDED|95.0|-24.6|1.3|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25.||1.3|-24.6|0.08
71710511|NCT01385995|142938145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.14|TWO_SIDED|95.0|-3.4|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, fasting insulin, between CPAP and sham-CPAP.||0.5|-3.4|0.14
71710512|NCT01385995|142938145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.12|TWO_SIDED|95.0|-23.3|2.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP.||2.8|-23.3|0.12
71710513|NCT01385995|142938145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1|TWO_SIDED|95.0|-5.2|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||0.5|-5.2|0.10
71710514|NCT01385995|142938145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.7||||0.002|TWO_SIDED|95.0|-46.5|-10.9|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||-10.9|-46.5|0.002
71710515|NCT01385995|142938146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.18|TWO_SIDED|95.0|-17.6|3.8|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP.||3.8|-17.6|0.18
71710516|NCT01385995|142938146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.08|TWO_SIDED|95.0|-27.5|1.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||1.8|-27.5|0.08
71826806|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.554|STANDARD_ERROR_OF_MEAN|0.219||0.0115|TWO_SIDED|95.0|-0.983|-0.125|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.125|-0.983|0.0115
71886728|NCT00523991|143293751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.19|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.29|0.19|<0.001
71826807|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.094|TWO_SIDED|95.0|-0.673|0.053|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.053|-0.673|0.0940
71710517|NCT01385995|142938147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.2|TWO_SIDED|95.0|-2.0|9.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensivity Index, between CPAP and sham-CPAP.||9.8|-2.0|0.20
71765842|NCT04093024|143033689|OTHER|No formal hypotheses were tested|Adjusted Mean Difference|-32.9|STANDARD_ERROR_OF_MEAN|33.8||0.3401|TWO_SIDED|95.0|-103.1|37.2|||Mixed Model Repeated Measures (MMRM)|Fixed categorical effects: (Randomised) treatment, age-group; Fixed continuous effects: Baseline at each visit, random effect for participant.|Adjusted mean difference was calculated as 'Randomised Nintedanib - randomised placebo'.|||37.2|-103.1|0.3401
71710518|NCT01385995|142938147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.3||||0.002|TWO_SIDED|95.0|5.2|22.1|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) \>=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.||22.1|5.2|0.002
71710519|NCT00964678|142938226|SUPERIORITY|||||||0.028|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
71710520|NCT00964678|142938227|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.028
71710521|NCT00964678|142938228|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0||||The threshold for statistical significance was p=0.05.|ANOVA|||||||>0.05
71710522|NCT00964678|142938229|SUPERIORITY||||||>|0.05|TWO_SIDED|20.0|||||ANOVA|||||||>0.05
71710523|NCT02489279|142938276|SUPERIORITY|||||||0.026|||||||GLM with repeated measures ANOVA|||We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.026
71765843|NCT00796445|143033721|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.|Hazard Ratio (HR)|1.013||||0.8566|TWO_SIDED|95.0|0.879|1.169|||Regression, Cox|||At Final analysis (Month 30)||1.169|0.879|0.8566
71765844|NCT00796445|143033721|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.111||||0.4821|TWO_SIDED|95.0|0.828|1.491|||Regression, Cox|||At Final analysis (Month 30)||1.491|0.828|0.4821
71765845|NCT00796445|143033721|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature|Hazard Ratio (HR)|0.915||||0.5375|TWO_SIDED|95.0|0.691|1.212|||Regression, Cox|||At Final analysis (Month 30)||1.212|0.691|0.5375
71826808|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.459|STANDARD_ERROR_OF_MEAN|0.18||0.0109|TWO_SIDED|95.0|-0.811|-0.106|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.106|-0.811|0.0109
71710524|NCT02489279|142938276|SUPERIORITY|||||||0.0075|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0075
71765846|NCT00796445|143033722|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement|Hazard Ratio (HR)|1.023||||0.7534|TWO_SIDED|95.0|0.89|1.175|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.175|0.890|0.7534
71886729|NCT00523991|143293767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"Terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.18|0.09|<0.001
71886730|NCT00523991|143293768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.001||95.0|0.16|0.25||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.25|0.16|<0.001
71710525|NCT02489279|142938276|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.25
71710526|NCT02489279|142938277|SUPERIORITY|||||||0.014|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.||||0.014
71710527|NCT02489279|142938277|SUPERIORITY|||||||0.0005|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.0005
71710528|NCT02489279|142938277|SUPERIORITY|||||||0.21|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.||||0.21
71710529|NCT02489279|142938278|SUPERIORITY|||||||1e-06|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.000001
71710530|NCT02489279|142938279|SUPERIORITY|||||||0.00018|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.||||0.00018
71710531|NCT02014467|142938291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|||<|0.0001|TWO_SIDED|95.0|3.67|5.18|||ANCOVA|||||5.18|3.67|<0.0001
71710532|NCT02014467|142938291|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.7495
71710533|NCT02014467|142938292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.21|||<|0.0001|TWO_SIDED|95.0|2.45|3.96|||ANCOVA|||||3.96|2.45|<0.0001
71710534|NCT02014467|142938292|SUPERIORITY_OR_OTHER|||||||0.9029||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.9029
71710535|NCT02014467|142938293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|||<|0.0001|TWO_SIDED|95.0|1.72|2.8|||ANCOVA|||||2.80|1.72|<0.0001
71710536|NCT02014467|142938293|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.1070
71710537|NCT02014467|142938294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.59|||<|0.0001|TWO_SIDED|95.0|0.98|2.2|||ANCOVA|||||2.20|0.98|<0.0001
71710538|NCT02014467|142938294|SUPERIORITY_OR_OTHER|||||||0.4369||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.4369
71710539|NCT02014467|142938295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.0001||95.0|2.39|4.32|||ANCOVA|||||4.32|2.39|<0.0001
71710540|NCT02014467|142938295|SUPERIORITY_OR_OTHER|||||||0.6082||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.6082
71710541|NCT02014467|142938296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.31|||<|0.0001|TWO_SIDED|95.0|2.74|3.88|||ANCOVA|||||3.88|2.74|<0.0001
71710542|NCT02014467|142938296|SUPERIORITY_OR_OTHER|||||||0.3513||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3513
71765847|NCT00796445|143033722|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.094||||0.5385|TWO_SIDED|95.0|0.821|1.457|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.457|0.821|0.5385
71886731|NCT00523991|143293769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium vesus placebo||0.28|0.18|<0.001
71710543|NCT02014467|142938297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|||<|0.0001|TWO_SIDED|95.0|1.96|3.27|||ANCOVA|||||3.27|1.96|<0.0001
71710544|NCT02014467|142938297|SUPERIORITY_OR_OTHER|||||||0.541||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.5410
71710545|NCT02014467|142938298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.72|||<|0.0001|TWO_SIDED|95.0|3.71|5.72|||ANCOVA|||||5.72|3.71|<0.0001
71710546|NCT02014467|142938298|SUPERIORITY_OR_OTHER|||||||0.3957||95.0||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA|||||||0.3957
71710547|NCT02014467|142938299|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.92|||<|0.0001|TWO_SIDED|95.0|-61.38|-52.65||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 6|||-52.65|-61.38|<0.0001
71710548|NCT02014467|142938299|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-52.56|||<|0.0001||95.0|-59.38|-46.17||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 12|||-46.17|-59.38|<0.0001
71710549|NCT02014467|142938300|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-56.94|||<|0.0001|TWO_SIDED|95.0|-61.6|-52.7||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 6|||-52.70|-61.60|<0.0001
71710550|NCT02014467|142938300|SUPERIORITY_OR_OTHER||Hodges Lehmann Estimate of Difference|-51.21|||<|0.0001|TWO_SIDED|95.0|-56.26|-45.91||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 12|||-45.91|-56.26|<0.0001
71710551|NCT02069847|142938319|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
71710552|NCT02069847|142938320|SUPERIORITY|||||||0.531|||||||t-test, 2 sided|||Total number of budesonide subjects with 50% or greater esophageal stricture (N=4) vs total number of control subjects with 50% or greater esophageal structure (N=15)||||0.531
71710553|NCT00831389|142938321|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.||||0.791
71710554|NCT00831389|142938322|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.||||0.5
71710555|NCT00831389|142938323|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.||||0.25
71710556|NCT00831389|142938324|SUPERIORITY_OR_OTHER|||||||0.0669||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.||||0.0669
71710557|NCT00831389|142938325|SUPERIORITY_OR_OTHER|||||||0.2256||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.||||0.2256
71710558|NCT00831389|142938326|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.||||0.791
71710559|NCT00831389|142938327|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.||||0.2036
71710560|NCT00831389|142938328|SUPERIORITY_OR_OTHER|||||||0.6221||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.||||0.6221
71710561|NCT00831389|142938329|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.||||0.021
71710562|NCT00831389|142938330|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p \< 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.||||0.0176
71710563|NCT00124657|142938339|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.75|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.48|1.0||||||1-year progression-free survival (n=8)||1.00|0.48|
71710564|NCT00124657|142938339|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.33|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.09|0.57||||||1-year progression-free survival (n=12)||0.57|0.09|
71710565|NCT00124657|142938339|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.45|STANDARD_DEVIATION|0.106|||TWO_SIDED|95.0|0.198|0.602||||||1-year progression free survival (n=20)||0.602|0.198|
71710566|NCT00124657|142938339|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.15|STANDARD_DEVIATION|0.069|||TWO_SIDED|95.0|0.015|0.285||||||2-year progression free survival (n=20)||0.285|0.015|
71710567|NCT00124657|142938339|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||1-year progression free survival (n=21)||0.341|0.039|
71710568|NCT00124657|142938339|SUPERIORITY_OR_OTHER||Kaplan-Meier|0.19|STANDARD_DEVIATION|0.077|||TWO_SIDED|95.0|0.039|0.341||||||2-year progression free survival (n=21)||0.341|0.039|
71710569|NCT04023045|142938352|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71765848|NCT00796445|143033722|NON_INFERIORITY|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.|Hazard Ratio (HR)|0.918||||0.5419|TWO_SIDED|95.0|0.698|1.207|||Regression, Cox|||At Follow-up analysis (up to Year 5)||1.207|0.698|0.5419
71765849|NCT00759564|143033757|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|124.71|||||TWO_SIDED|90.0|106.57|145.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||145.94|106.57|
71765850|NCT00759564|143033757|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|163.51|||||TWO_SIDED|90.0|139.72|191.34||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||191.34|139.72|
71765851|NCT00759564|143033757|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|58.4|||||TWO_SIDED|90.0|48.16|70.83||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||70.83|48.16|
71765852|NCT00759564|143033759|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|167.59|||||TWO_SIDED|90.0|137.27|204.61||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||204.61|137.27|
71710570|NCT04023045|142938353|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710571|NCT04023045|142938354|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710572|NCT04023045|142938355|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710573|NCT04023045|142938356|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710574|NCT04023045|142938357|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710575|NCT04023045|142938358|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710576|NCT04023045|142938359|OTHER||||||||||||||||||Descriptive analyses (mean and standard deviation) were used to compare the Habitual condition to the Assist-Knee conditions.|||
71710577|NCT00841815|142938360|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|96.43||||||90.0|91.4|101.74|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.74|91.40|
71710578|NCT00841815|142938361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.94||||||90.0|95.6|106.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.58|95.60|
71710579|NCT00841815|142938362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.11||||||90.0|95.08|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.40|95.08|
71710580|NCT04805593|142938363|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 50%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
71710581|NCT04805593|142938364|SUPERIORITY|Superiority testing was conducted to confirm the proportion is higher than the targeted value of 75%.|||||<|0.0001|||||||Exact Test of Binomial Proportion|||||||<0.0001
71710582|NCT03464461|142938372|OTHER|non-parametric||||||0.9844|||||||Kruskal-Wallis|||||||0.9844
71710583|NCT03464461|142938373|OTHER|non-parametric||||||0.158|||||||Kruskal-Wallis|||||||0.1580
71710584|NCT03464461|142938374|OTHER|non-parametric||||||0.873|||||||Kruskal-Wallis|||||||0.8730
71710585|NCT03464461|142938375|OTHER|non-parametric||||||0.074|||||||Kruskal-Wallis|||||||0.0740
71710586|NCT03464461|142938376|OTHER|non-parametric||||||0.0984|||||||Kruskal-Wallis|||||||0.0984
71710587|NCT03685149|142938380|SUPERIORITY||percent reduction|72.0|||<|0.0001|TWO_SIDED|95.0|56.0|82.0|||Mixed Models Analysis|||||82|56|<0.0001
71710588|NCT03685149|142938381|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71710589|NCT03685149|142938382|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71710590|NCT03685149|142938383|SUPERIORITY|||||||0.207|||||||Wilcoxon (Mann-Whitney)|||||||0.207
71710591|NCT03647137|142938397|OTHER||Standardized β Coefficient|-2.256||||0.00468|TWO_SIDED|||||The p-value is derived from model comparison between the FEOVB model and the FEOVB\*PIB interaction model.|ChiSq Goodness of Fit Test|||L-DOPA sensitivity outcome measure was modeled with 3-level hierarchical ordinal logistic regression. The null model contained only striatal DTBZ as predictor of group, the FEOVB model additionally had FEOVB tracer, and interaction model had in addition an interaction term between FEOVB and PIB tracer. Model comparisons were performed using Chi-Square goodness of fit test.||||0.00468
71710592|NCT00209131|142938427|NON_INFERIORITY_OR_EQUIVALENCE||||||<|0.05||95.0|||||Other|||No analysis was conducted.||||<0.05
71710593|NCT04918771|142938486|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0003|TWO_SIDED|95.0|0.51|1.67|||t-test, 2 sided|||Mean time to resolution of ARVI symptoms||1.67|0.51|0.0003
71710594|NCT04918771|142938487|SUPERIORITY||Mean Difference (Final Values)|2.35||||0.3274|TWO_SIDED|95.0|-2.36|7.06|||t-test, 2 sided|||Mean AUC score for severity of ARVI (Clinically Diagnosed and/or PCR-confirmed).||7.06|-2.36|0.3274
71710595|NCT04918771|142938487|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.1171|TWO_SIDED|95.0|-1.34|11.93|||t-test, 2 sided|||Mean AUC score for severity of ARVI (PCR-confirmed).||11.93|-1.34|0.1171
71710596|NCT04918771|142938488|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71710597|NCT04918771|142938489|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.0073|TWO_SIDED|95.0|0.16|1.0|||t-test, 2 sided|||The mean time to Resolution of ARVI Symptoms was analysed.||1.00|0.16|0.0073
71710598|NCT04918771|142938490|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71710599|NCT04918771|142938491|SUPERIORITY|||||||0.3627|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 1.||||0.3627
71710600|NCT04918771|142938491|SUPERIORITY|||||||0.5578|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 2.||||0.5578
71710601|NCT04918771|142938491|SUPERIORITY|||||||0.7688|||||||Wilcoxon (Mann-Whitney)|||Dosing Frequency of Antipyretics. Comparison for Day 3.||||0.7688
71710602|NCT04918771|142938492|SUPERIORITY|||||||0.4926|||||||Fisher Exact|||||||0.4926
71710603|NCT04918771|142938493|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Comparison of severity distributions.||||0.021
71710604|NCT04918771|142938493|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for outcome distribution.||||1.00
71710605|NCT04918771|142938494|SUPERIORITY|||||||0.7848|||||||Median test|||Comparison for Visit 1.||||0.7848
71710606|NCT04918771|142938494|SUPERIORITY|||||||0.9596|||||||Median test|||Comparison for Visit 2.||||0.9596
71710607|NCT04918771|142938494|SUPERIORITY|||||||0.6902|||||||Median test|||Comparison for Visit 3.||||0.6902
71710608|NCT04918771|142938495|SUPERIORITY|||||||0.3266|||||||Median test|||Comparison for Visit 1.||||0.3266
71710609|NCT04918771|142938495|SUPERIORITY|||||||0.093|||||||Median test|||Comparison for Visit 2.||||0.0930
71710610|NCT04918771|142938495|SUPERIORITY|||||||0.2308|||||||Median test|||Comparison for Visit 3.||||0.2308
71710611|NCT04918771|142938496|SUPERIORITY|||||||0.661|||||||Median test|||Comparison for Visit 1/Systolic blood pressure.||||0.6610
71710612|NCT04918771|142938496|SUPERIORITY|||||||0.4884|||||||Median test|||Comparison for Visit 2/Systolic blood pressure.||||0.4884
71710613|NCT04918771|142938496|SUPERIORITY|||||||0.3494|||||||Median test|||Comparison for Visit 3/Systolic blood pressure.||||0.3494
71710614|NCT04918771|142938496|SUPERIORITY|||||||0.9531|||||||Median test|||Comparison for Visit 1/Diastolic blood pressure.||||0.9531
71710615|NCT04918771|142938496|SUPERIORITY|||||||0.5506|||||||Median test|||Comparison for Visit 2/Diastolic blood pressure.||||0.5506
71710616|NCT04918771|142938496|SUPERIORITY|||||||0.8259|||||||Median test|||Comparison for Visit 3/Diastolic blood pressure.||||0.8259
71710617|NCT04918771|142938497|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71710618|NCT01287208|142938519|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71710619|NCT01287208|142938522|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71710620|NCT01299961|142938524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4|STANDARD_DEVIATION|13.1|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.||||<0.01
71710621|NCT01299961|142938525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.7|<|0.01|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.||||<0.01
71710622|NCT01299961|142938526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|3.7||0.19|TWO_SIDED||||||t-test, 2 sided|||7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.||||0.19
71710623|NCT02904096|142938527|NON_INFERIORITY|Estimates for PA, PB, and PA-PB were reported together with one-sided 95% confidence interval (CI) for PA-PB constructed via the Farrington-Manning likelihood method. Here PA and PB are the percentage of subjects in Group A and B (Non-inferiority margin = 12%).|Difference in percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
71710624|NCT02904096|142938528|OTHER||Difference in Percentage|1.5|||||ONE_SIDED|95.0||3.35||||||||3.35||
71710625|NCT02904096|142938529|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.||||<.001
71710626|NCT02904096|142938529|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
71710627|NCT02904096|142938529|OTHER|||||||0.054|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.||||.054
71710628|NCT02904096|142938529|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.||||<.001
71710629|NCT02904096|142938529|OTHER|||||||0.049|||||||t-test, 1 sided|||Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.||||.049
71710630|NCT02904096|142938529|OTHER|||||||0.003|||||||t-test, 1 sided|||Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.||||.003
71765853|NCT00759564|143033759|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|246.76|||||TWO_SIDED|90.0|202.11|301.27||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||301.27|202.11|
71765854|NCT00759564|143033759|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|107.13|||||TWO_SIDED|90.0|88.06|130.32||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||130.32|88.06|
71765855|NCT00759564|143033760|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|168.14|||||TWO_SIDED|90.0|137.4|205.75||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||205.75|137.40|
71765856|NCT00759564|143033760|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|248.38|||||TWO_SIDED|90.0|202.98|303.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||303.94|202.98|
71765857|NCT00759564|143033760|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|110.12|||||TWO_SIDED|90.0|89.84|134.98||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||134.98|89.84|
71765858|NCT00759564|143033762|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|134.86|||||TWO_SIDED|90.0|109.88|165.52||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||165.52|109.88|
71886732|NCT00523991|143293770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.2|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.29|0.20|<0.001
71886733|NCT00523991|143293771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001||95.0|0.2|0.3||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.30|0.20|<0.001
71710631|NCT02904096|142938529|OTHER|||||||0.781|||||||t-test, 1 sided|||Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.||||.781
71710632|NCT02904096|142938529|OTHER|||||||0.573|||||||t-test, 1 sided|||Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.||||.573
71710633|NCT02904096|142938530|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
71710634|NCT02904096|142938530|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
71710635|NCT02904096|142938530|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
71710636|NCT02904096|142938530|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
71710637|NCT02904096|142938531|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.||||<.001
71710638|NCT02904096|142938531|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.||||<.001
71710639|NCT02904096|142938531|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.||||<.001
71710640|NCT02904096|142938531|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.||||<.001
71710641|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
71886734|NCT00523991|143293775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|||<|0.001||95.0|0.24|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.24|<0.001
71710642|NCT02904096|142938532|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.001
71710643|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.||||<.001
71710644|NCT02904096|142938532|OTHER|||||||0.002|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.||||.002
71710645|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
71710646|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71710647|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
71710648|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71710649|NCT02904096|142938532|OTHER|||||||0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||.001
71765859|NCT00759564|143033762|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|226.28|||||TWO_SIDED|90.0|184.36|277.72||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||277.72|184.36|
71886735|NCT00523991|143293779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and trough forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.28|0.14|<0.001
71710650|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71710651|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.||||<.001
71710652|NCT02904096|142938532|OTHER||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.||||<.001
71710653|NCT02904096|142938532|OTHER|||||||0.01|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.010
71710654|NCT02904096|142938532|OTHER|||||||0.06|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.060
71710655|NCT02904096|142938532|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.||||.177
71710656|NCT02904096|142938532|OTHER|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.||||.177
71710657|NCT04003389|142938563|SUPERIORITY||LSMean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.0604|TWO_SIDED|95.0|-0.36|0.21||LSM, SE, CI, \& p-values come from an analysis of covariance (ANCOVA) model with change from baseline at Week 52 timepoint as response, treatment \& smoking status (current vs former/never) as fixed effects with baseline weight \& baseline as covariate.|ANCOVA|||LSMeans (LSM), standard errors (SE), confidence intervals (CI)||0.21|-0.36|0.0604
71710658|NCT04003389|142938563|SUPERIORITY||LSMean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.45|0.11||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.11|-0.45|0.239
71710659|NCT04003389|142938565|SUPERIORITY||LSMean difference|0.007|STANDARD_ERROR_OF_MEAN|0.003||0.029|TWO_SIDED|95.0|0.001|0.014||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.014|0.001|0.029
71710660|NCT04003389|142938565|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.003||0.867|TWO_SIDED|95.0|-0.006|0.007||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.007|-0.006|0.867
71710661|NCT04003389|142938565|SUPERIORITY||LSMean difference|0.006|STANDARD_ERROR_OF_MEAN|0.003||0.027|TWO_SIDED|95.0|0.001|0.012||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.012|0.001|0.027
71710662|NCT04003389|142938565|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.003||0.41|TWO_SIDED|95.0|-0.003|0.008||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.008|-0.003|0.410
71765860|NCT00759564|143033762|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|285.05|||||TWO_SIDED|90.0|221.8|366.33||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||366.33|221.80|
71765861|NCT00759564|143033764|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.31|||||TWO_SIDED|90.0|158.81|275.87||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||275.87|158.81|
71765862|NCT00759564|143033764|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.0|||||TWO_SIDED|90.0|267.83|465.25||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||465.25|267.83|
71765863|NCT00759564|143033764|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|742.68|||||TWO_SIDED|90.0|529.59|1041.5||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1041.50|529.59|
71765864|NCT00759564|143033765|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|209.55|||||TWO_SIDED|90.0|158.72|276.66||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||276.66|158.72|
71765865|NCT00759564|143033765|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|353.26|||||TWO_SIDED|90.0|267.57|466.39||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||466.39|267.57|
71765866|NCT00759564|143033765|SUPERIORITY_OR_OTHER||Percent Geometric Mean Ratio|735.77|||||TWO_SIDED|90.0|523.56|1034.0||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||1034.00|523.56|
71765867|NCT00329849|143033793|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|38.0|||||TWO_SIDED|95.0|29.0|47.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS||47|29|
71765868|NCT00329849|143033793|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|30.0|||||TWO_SIDED|95.0|19.0|40.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS||40|19|
71765869|NCT00329849|143033793|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|28.0|||||TWO_SIDED|95.0|17.0|39.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS||39|17|
71710663|NCT04003389|142938565|SUPERIORITY||LSMean difference|0.005|STANDARD_ERROR_OF_MEAN|0.003||0.087||95.0|-0.001|0.011||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.011|-0.001|0.087
71765870|NCT00329849|143033793|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|18.0|||||TWO_SIDED|95.0|8.0|28.0|||Chi-squared|||Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS||28|8|
71886736|NCT00523991|143293783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.24|0.42||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.42|0.24|<0.001
71710664|NCT04003389|142938565|SUPERIORITY||LSMean difference|0.003|STANDARD_ERROR_OF_MEAN|0.003||0.259||95.0|-0.002|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.009|-0.002|0.259
71710665|NCT04003389|142938566|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.079|TWO_SIDED|95.0|-0.006|0.102||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.102|-0.006|0.079
71710666|NCT04003389|142938566|SUPERIORITY||LSMean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.98|TWO_SIDED|95.0|-0.052|0.053||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femoral Neck)||0.053|-0.052|0.980
71710667|NCT04003389|142938566|SUPERIORITY||LSMean difference|0.048|STANDARD_ERROR_OF_MEAN|0.023||0.042||95.0|0.002|0.094||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.094|0.002|0.042
71710668|NCT04003389|142938566|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.023||0.386||95.0|-0.025|0.065||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Femur)||0.065|-0.025|0.386
71710669|NCT04003389|142938566|SUPERIORITY||LSMean difference|0.041|STANDARD_ERROR_OF_MEAN|0.029||0.156||95.0|-0.016|0.099||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.099|-0.016|0.156
71710670|NCT04003389|142938566|SUPERIORITY||LSMean difference|0.028|STANDARD_ERROR_OF_MEAN|0.029||0.328|TWO_SIDED|95.0|-0.028|0.084||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||Hip (Trochanter)||0.084|-0.028|0.328
71710671|NCT04003389|142938567|SUPERIORITY||LSMean difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.497||95.0|-0.005|0.009||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.009|-0.005|0.497
71765871|NCT00329849|143033794|NON_INFERIORITY_OR_EQUIVALENCE|Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.|Group Ratio|6.37|||||TWO_SIDED|95.0|0.82|49.2|||Risk ratio(MenACWY-CRM/MenACWY-PS)|||||49.2|0.82|
71765872|NCT03996369|143033800|SUPERIORITY||Risk Difference (RD)|9.69|||=|0.026|TWO_SIDED|95.0|1.14|18.23|||Cochran-Mantel-Haenszel|||Week 12||18.23|1.14|=0.026
71826809|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.667|STANDARD_ERROR_OF_MEAN|0.208||0.0014|TWO_SIDED|95.0|-1.075|-0.259|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.259|-1.075|0.0014
71765873|NCT03996369|143033801|SUPERIORITY||Risk Difference (RD)|12.11|||=|0.009|TWO_SIDED|95.0|3.0|21.23|||Cochran-Mantel-Haenszel|||Week 12||21.23|3.00|=0.009
71765874|NCT03996369|143033802|SUPERIORITY||Risk Difference (RD)|17.48|||=|0.001|TWO_SIDED|95.0|6.81|28.15|||Cochran-Mantel-Haenszel|||Week 12||28.15|6.81|=0.001
71765875|NCT03996369|143033803|SUPERIORITY||Risk Difference (RD)|7.44|||=|0.036|TWO_SIDED|95.0|0.5|14.39|||Cochran-Mantel-Haenszel|||Week 12||14.39|0.50|=0.036
71765876|NCT03996369|143033804|SUPERIORITY||Risk Difference (RD)|21.23|||<|0.001|TWO_SIDED|95.0|10.18|32.29|||Cochran-Mantel-Haenszel|||Week 12||32.29|10.18|<0.001
71710672|NCT04003389|142938567|SUPERIORITY||LSMean difference|-0.001|STANDARD_ERROR_OF_MEAN|0.004||0.878||95.0|-0.007|0.006||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.006|-0.007|0.878
71710673|NCT04003389|142938568|SUPERIORITY||LSMean difference|0.02|STANDARD_ERROR_OF_MEAN|0.031||0.527|TWO_SIDED|95.0|-0.042|0.082||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.082|-0.042|0.527
71710674|NCT04003389|142938568|SUPERIORITY||LSMean difference|-0.005|STANDARD_ERROR_OF_MEAN|0.031||0.872||95.0|-0.066|0.056||The LSM, SE, CI, and p-values come from an ANCOVA model with change from baseline at the Week 52 timepoint as response, treatment and smoking status (current vs former/never) as fixed effects with baseline weight and baseline as covariates.|ANCOVA|||||0.056|-0.066|0.872
71710675|NCT00835354|142938586|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|89.2||||||90.0|86.2|92.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.2|86.2|
71765877|NCT03996369|143033805|SUPERIORITY||Risk Difference (RD)|9.24|||=|0.009|TWO_SIDED|95.0|2.27|16.2|||Cochran-Mantel-Haenszel|||Week 12||16.20|2.27|=0.009
71765878|NCT03996369|143033806|SUPERIORITY||Risk Difference (RD)|5.85|||=|0.115|TWO_SIDED|95.0|-1.42|13.13|||Cochran-Mantel-Haenszel|||Week 2||13.13|-1.42|=0.115
71765879|NCT03996369|143033806|SUPERIORITY||Risk Difference (RD)|11.83|||=|0.007|TWO_SIDED|95.0|3.19|20.47|||Cochran-Mantel-Haenszel|||Week 4||20.47|3.19|=0.007
71765880|NCT03996369|143033806|SUPERIORITY||Risk Difference (RD)|14.84|||=|0.003|TWO_SIDED|95.0|4.98|24.69|||Cochran-Mantel-Haenszel|||Week 8||24.69|4.98|=0.003
71826810|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.447|STANDARD_ERROR_OF_MEAN|0.213||0.0364|TWO_SIDED|95.0|-0.867|-0.028|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.028|-0.867|0.0364
71710676|NCT00835354|142938587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.5||||||90.0|88.9|92.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.1|88.9|
71710677|NCT00835354|142938588|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|90.7||||||90.0|89.1|92.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||92.3|89.1|
71710678|NCT04101331|142938648|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
71710679|NCT04101331|142938649|OTHER|||||||0.051||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.051
71710680|NCT04101331|142938650|OTHER|||||||0.112||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.112
71710681|NCT04101331|142938652|OTHER|||||||0.537||||||One-sided p-value.|Exact binomial test|Exact binomial test compares versus a proportion of 0.25.||||||0.537
71710682|NCT04378153|142938672|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
71710683|NCT00488293|142938673|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71710684|NCT00488293|142938674|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Chi-squared|||||||0.88
71710685|NCT00488293|142938675|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||t-test, 2 sided|||||||0.39
71710686|NCT00488293|142938676|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71710687|NCT00488293|142938677|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
71710688|NCT00488293|142938678|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
71710689|NCT00488293|142938679|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
71710690|NCT00488293|142938680|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
71710691|NCT00488293|142938681|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71710692|NCT00488293|142938682|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Chi-squared|||||||0.65
71710693|NCT00500331|142938683|OTHER|Tukey's trend test for dose response: Change= Baseline+Treatment|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change= Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mg||||<0.001
71710694|NCT00500331|142938683|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg||||<0.001
71710695|NCT00500331|142938683|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg||||<0.001
71710696|NCT00500331|142938683|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg||||<0.001
71710697|NCT00500331|142938683|OTHER|Tukey's trend test for dose response|||||<|0.001||||||Tukey's trend test adjusts for multiplicity with statistical significance based on p-value \<0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg||||<0.001
71710698|NCT00500331|142938683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.02|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 50 mg||-0.44|-1.02|<0.001
71710699|NCT00500331|142938683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.94|-0.35||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 100 mg||-0.35|-0.94|<0.001
71710700|NCT00500331|142938683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 250 mg||-0.44|-1.03|<0.001
71710701|NCT00500331|142938683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.19|-0.61||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 500 mg||-0.61|-1.19|<0.001
71710702|NCT00500331|142938683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.36|-0.77||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 1000 mg||-0.77|-1.36|<0.001
71710703|NCT00500331|142938683|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76|||<|0.001|TWO_SIDED|95.0|-1.05|-0.47||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. Pioglitazone 30 mg||-0.47|-1.05|<0.001
71710704|NCT03345550|142938706|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||Baseline||||.24
71710705|NCT03345550|142938706|SUPERIORITY|||||||0.43|||||||Kruskal-Wallis|||1 month analysis||||.43
71710706|NCT03345550|142938706|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||3 month||||.54
71710707|NCT03345550|142938709|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||.31
71710708|NCT00586157|142938743|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Z-test|||||||<.001
71710709|NCT00586157|142938744|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Z-test|||||||.001
71710710|NCT00586157|142938745|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Z-test|||||||.003
71710711|NCT06045273|142938848|SUPERIORITY||Slope|0.224|STANDARD_ERROR_OF_MEAN|0.064||0.0006|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0006
71710712|NCT06045273|142938849|SUPERIORITY||Slope|0.084|STANDARD_ERROR_OF_MEAN|0.043||0.0504|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.0504
71710713|NCT06045273|142938850|SUPERIORITY||Slope|0.131|STANDARD_ERROR_OF_MEAN|0.04||0.00134|TWO_SIDED||||||Satterthwaite approximations|Also used a mixed models analysis||||||0.00134
71710714|NCT02743221|142938863|OTHER|This was a non-comparative study.|Hazard Ratio (HR)|0.71||||0.09|TWO_SIDED|95.0|0.48|1.06|||Cox proportional hazard model|Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)||||1.06|0.48|0.09
71710715|NCT02743221|142938864|OTHER|||||||0.73|||||||Fisher Exact|||||||0.73
71710716|NCT02743221|142938865|OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.49|2.74||||||||2.74|0.49|
71710717|NCT02743221|142938866|OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
71710718|NCT02743221|142938867|OTHER||Hazard Ratio (HR)|0.56||||0.04|TWO_SIDED|95.0|0.32|0.98|||Cox proportional hazard model|||||0.98|0.32|0.04
71710719|NCT04770285|142938877|SUPERIORITY||Treatment Difference|-1.78||||0.0568|TWO_SIDED|95.0|-3.6|0.05|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.05|-3.60|0.0568
71710720|NCT04770285|142938878|SUPERIORITY||Treatment Difference|-0.77||||0.0705|TWO_SIDED|95.0|-1.61|0.07|||MMRM|p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.||||0.07|-1.61|0.0705
71710721|NCT04770285|142938879|SUPERIORITY||Treatment Difference|-0.62||||0.3687|TWO_SIDED|95.0|-1.99|0.74||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.74|-1.99|0.3687
71765881|NCT03996369|143033807|SUPERIORITY||Risk Difference (RD)|2.83|||=|0.128|TWO_SIDED|95.0|-0.81|6.48|||Cochran-Mantel-Haenszel|||Week 2||6.48|-0.81|=0.128
71765882|NCT03996369|143033807|SUPERIORITY||Risk Difference (RD)|8.32|||=|0.002|TWO_SIDED|95.0|3.01|13.64|||Cochran-Mantel-Haenszel|||Week 4||13.64|3.01|=0.002
71710722|NCT04770285|142938879|SUPERIORITY||Treatment Difference|-1.45||||0.0828|TWO_SIDED|95.0|-3.1|0.19||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.19|-3.10|0.0828
71765883|NCT03996369|143033807|SUPERIORITY||Risk Difference (RD)|7.06|||=|0.032|TWO_SIDED|95.0|0.62|13.49|||Cochran-Mantel-Haenszel|||Week 8||13.49|0.62|=0.032
71765884|NCT03996369|143033807|SUPERIORITY||Risk Difference (RD)|9.18|||=|0.014|TWO_SIDED|95.0|1.82|16.54|||Cochran-Mantel-Haenszel|||Week 12||16.54|1.82|=0.014
71765885|NCT03996369|143033808|SUPERIORITY||Risk Difference (RD)|15.55|||=|0.002|TWO_SIDED|95.0|5.65|25.46|||Cochran-Mantel-Haenszel|||Week 2||25.46|5.65|=0.002
71710723|NCT04770285|142938880|SUPERIORITY||Treatment Difference|-0.34||||0.3549|TWO_SIDED|95.0|-1.06|0.38||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||0.38|-1.06|0.3549
71710724|NCT04770285|142938880|SUPERIORITY||Treatment Difference|-0.28||||0.4948|TWO_SIDED|95.0|-1.09|0.53||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||0.53|-1.09|0.4948
71710725|NCT04770285|142938881|SUPERIORITY||Ratio of Response Rate|1.68||||0.142|TWO_SIDED|95.0|0.84|3.34||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||3.34|0.84|0.1420
71710726|NCT04770285|142938881|SUPERIORITY||Ratio of Response Rate|1.31||||0.2939|TWO_SIDED|95.0|0.79|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||2.16|0.79|0.2939
71710727|NCT04770285|142938881|SUPERIORITY||Ratio of Response Rate|1.38||||0.0884|TWO_SIDED|95.0|0.96|1.99||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.99|0.96|0.0884
71710728|NCT04770285|142938882|SUPERIORITY||Treatment Difference|-0.19||||0.0039|TWO_SIDED|95.0|-0.32|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 2||-0.06|-0.32|0.0039
71710729|NCT04770285|142938882|SUPERIORITY||Treatment Difference|-0.32||||0.0003|TWO_SIDED|95.0|-0.5|-0.15||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.15|-0.50|0.0003
71710730|NCT04770285|142938882|SUPERIORITY||Treatment Difference|-0.26||||0.0098|TWO_SIDED|95.0|-0.46|-0.06||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.06|-0.46|0.0098
71710731|NCT04770285|142938883|SUPERIORITY||Treatment Difference|-1.02||||0.4463|TWO_SIDED|95.0|-3.66|1.61||p-value was calculated by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|ANCOVA|||||1.61|-3.66|0.4463
71710732|NCT04770285|142938884|SUPERIORITY||Treatment Difference|-1.29||||0.0102|TWO_SIDED|95.0|-2.28|-0.31||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 4||-0.31|-2.28|0.0102
71710733|NCT04770285|142938884|SUPERIORITY||Treatment Difference|-1.58||||0.0029|TWO_SIDED|95.0|-2.62|-0.54||p-value was calculated by MMRM method with model terms: Treatment, trial center, visit, treatment by visit, and baseline by visit interaction.|MMRM|||Week 6||-0.54|-2.62|0.0029
71710734|NCT04770285|142938885|SUPERIORITY||Ratio of Response Rate|1.18||||0.5757|TWO_SIDED|95.0|0.65|2.16||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 2||2.16|0.65|0.5757
71710735|NCT04770285|142938885|SUPERIORITY||Ratio of Response Rate|1.16||||0.5102|TWO_SIDED|95.0|0.75|1.78||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 4||1.78|0.75|0.5102
71765886|NCT03996369|143033808|SUPERIORITY||Risk Difference (RD)|14.98|||=|0.007|TWO_SIDED|95.0|4.05|25.91|||Cochran-Mantel-Haenszel|||Week 4||25.91|4.05|=0.007
71765887|NCT03996369|143033808|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.95|33.25|||Cochran-Mantel-Haenszel|||Week 8||33.25|11.95|<0.001
71765888|NCT03996369|143033808|SUPERIORITY||Risk Difference (RD)|17.58|||=|0.002|TWO_SIDED|95.0|6.7|28.47|||Cochran-Mantel-Haenszel|||Week 12||28.47|6.70|=0.002
71710736|NCT04770285|142938885|SUPERIORITY||Ratio of Response Rate|1.15||||0.5342|TWO_SIDED|95.0|0.74|1.79||p-value was calculated by Cochran-Mantel-Haenzsel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 6||1.79|0.74|0.5342
71710737|NCT04770285|142938886|SUPERIORITY||Ratio of Response Rate|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Week 8||1.22|0.82|
71710738|NCT04770285|142938886|SUPERIORITY||Ratio of Response Rate|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||Week 10||1.25|0.88|
71710739|NCT00437073|142938915|SUPERIORITY_OR_OTHER||percentage of participants|38.0|||||TWO_SIDED|95.0|13.9|68.4|||||The estimated value indicates the percentage of participants with CNS OR in the Lapatinib plus Capecitabine treatment arm.|||68.4|13.9|
71710740|NCT01441492|142938939|OTHER|||||||0.804|||||||Chi-squared|||the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.||||0.804
71710741|NCT00666263|142938978|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|35.13||||0.005|TWO_SIDED|95.0|8.81|61.46|||ANOVA|Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), \& treatment (IGIV, 10% or placebo)||||61.46|8.81|0.005
71765889|NCT03996369|143033809|SUPERIORITY||Risk Difference (RD)|15.99|||=|0.002|TWO_SIDED|95.0|6.07|25.91|||Cochran-Mantel-Haenszel|||Week 2||25.91|6.07|=0.002
71765890|NCT03996369|143033809|SUPERIORITY||Risk Difference (RD)|15.45|||=|0.006|TWO_SIDED|95.0|4.54|26.36|||Cochran-Mantel-Haenszel|||Week 4||26.36|4.54|=0.006
71765891|NCT03996369|143033809|SUPERIORITY||Risk Difference (RD)|22.14|||<|0.001|TWO_SIDED|95.0|11.43|32.85|||Cochran-Mantel-Haenszel|||Week 8||32.85|11.43|<0.001
71710742|NCT00666263|142938979|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
71710743|NCT00666263|142938981|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squared means|32.54|||<|0.001|TWO_SIDED|95.0|14.01|51.06|||ANOVA|||||51.06|14.01|<0.001
71710744|NCT00666263|142938982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
71765892|NCT03996369|143033809|SUPERIORITY||Risk Difference (RD)|18.49|||<|0.001|TWO_SIDED|95.0|7.65|29.33|||Cochran-Mantel-Haenszel|||Week 12||29.33|7.65|<0.001
71765893|NCT04620798|143033845|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.07|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.07|0.96|
71765894|NCT04620798|143033845|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.44|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.44|0.77|
71765895|NCT04620798|143033846|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.10|0.89|
71765896|NCT04620798|143033846|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.62|0.50|
71765897|NCT04620798|143033847|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.96|1.06|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.96|
71826811|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.271|STANDARD_ERROR_OF_MEAN|0.185||0.1436|TWO_SIDED|95.0|-0.634|0.092|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.092|-0.634|0.1436
71710745|NCT00666263|142938986|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|6.03||||0.002|TWO_SIDED|95.0|2.14|9.92|||ANOVA|||||9.92|2.14|0.002
71710746|NCT00666263|142938988|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-15.57|||<|0.001|TWO_SIDED|95.0|-24.37|-6.77|||ANOVA|||||-6.77|-24.37|<0.001
71710747|NCT00666263|142938990|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-26.11|||<|0.001|TWO_SIDED|95.0|-38.96|-13.26|||ANOVA|||||-13.26|-38.96|<0.001
71710748|NCT00666263|142938992|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squared Means|-216.6||||0.059|TWO_SIDED|95.0|-490.41|57.22|||ANOVA|||||57.22|-490.41|0.059
71710749|NCT00666263|142938994|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED|95.0|||||McNemar|||||||<0.001
71710750|NCT00666263|142938995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0|||||McNemar|||||||0.021
71710751|NCT00062764|142939009|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||paired t-test|||||||0.004
71710752|NCT02378480|142939036|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||4.9|-6.3|
71826812|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.18||0.0246|TWO_SIDED|95.0|-0.757|-0.052|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.052|-0.757|0.0246
71710753|NCT02378480|142939037|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||TWO_SIDED|95.0|-3.2|8.2|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.2|-3.2|
71710754|NCT02378480|142939038|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.8|||||TWO_SIDED|95.0|-1.0|6.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||6.9|-1.0|
71710755|NCT01217892|142939040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.084||0.0106|TWO_SIDED|95.0|-0.38|-0.05||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.05|-0.38|0.0106
71710756|NCT01217892|142939040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0843|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)||-0.18|-0.52|<0.0001
71710757|NCT01217892|142939041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.363|<|0.0001|TWO_SIDED|95.0|-2.53|-1.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.10|-2.53|<0.0001
71710758|NCT01217892|142939041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.3636|<|0.0001|TWO_SIDED|95.0|-2.89|-1.46||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-1.46|-2.89|<0.0001
71710759|NCT01217892|142939042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|3.04|<|0.0001|TWO_SIDED|95.0|-21.7|-9.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.7|-21.7|<0.0001
71710760|NCT01217892|142939042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|STANDARD_ERROR_OF_MEAN|3.039|<|0.0001|TWO_SIDED|95.0|-22.7|-10.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-10.7|-22.7|<0.0001
71710761|NCT01217892|142939043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.132||0.001|TWO_SIDED|95.0|-16.5|-4.2||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-4.2|-16.5|0.0010
71710762|NCT01217892|142939043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|3.139|<|0.0001|TWO_SIDED|95.0|-21.4|-9.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c \<7.0% vs \>=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)||-9.1|-21.4|<0.0001
71826813|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.546|STANDARD_ERROR_OF_MEAN|0.208||0.0088|TWO_SIDED|95.0|-0.954|-0.138|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.138|-0.954|0.0088
71826814|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.267|STANDARD_ERROR_OF_MEAN|0.213||0.2121|TWO_SIDED|95.0|-0.686|0.152|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.152|-0.686|0.2121
71710763|NCT01217892|142939044|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|6.097||0.0455|TWO_SIDED|95.0|0.2|24.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||24.1|0.2|0.0455
71710764|NCT01217892|142939044|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.8|STANDARD_ERROR_OF_MEAN|6.153||0.0062|TWO_SIDED|95.0|4.8|28.9||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||28.9|4.8|0.0062
71710765|NCT01052779|142939045|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.1||||0.515|TWO_SIDED|95.0|-0.21|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.21|0.515
71710766|NCT01052779|142939045|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.09||||0.587|TWO_SIDED|95.0|-0.23|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.||0.41|-0.23|0.587
71710767|NCT03802916|142939049|SUPERIORITY|||||||0.0074||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0074
71710768|NCT03802916|142939049|SUPERIORITY|||||||0.0002||||||A p-value was calculated for the one-sample proportion test.|One-sample proportion test|||One-sample proportion test to determine if the overall preference for deferiprone DR was greater than chance (i.e., a 50% preference for each formulation)||||0.0002
71710769|NCT01905540|142939053|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.244|||||TWO_SIDED|90.0|1.081|1.43||||||||1.430|1.081|
71710770|NCT01905540|142939054|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Geometric LS Means|1.233|||||TWO_SIDED|90.0|1.07|1.422||||||||1.422|1.070|
71710771|NCT01905540|142939055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.344|||||TWO_SIDED|90.0|1.135|1.592||||||||1.592|1.135|
71710772|NCT02743962|142939098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|2.12|||TWO_SIDED|||||||||The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.||||
71710773|NCT02743962|142939098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.25|STANDARD_DEVIATION|2.67|||TWO_SIDED|||||||||There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group's score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).||||
71710774|NCT04330859|142939147|SUPERIORITY||Agresti-Caffo|95.0||||0.0543|TWO_SIDED|||||58.8 ± 7.2 (intervention) and 57.2 ± 11.2 (control; p = 0.0543)|t-test, 1 sided|||||||0.0543
71826815|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.185||0.5975|TWO_SIDED|95.0|-0.461|0.265|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.265|-0.461|0.5975
71826816|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.464|STANDARD_ERROR_OF_MEAN|0.18||0.0099|TWO_SIDED|95.0|-0.817|-0.112|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.112|-0.817|0.0099
71710775|NCT03766399|142939198|OTHER||LS means difference|-0.44||||0.9511|TWO_SIDED|90.0|-12.9|12.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||12.0|-12.9|0.9511
71710776|NCT03766399|142939198|OTHER||LS means difference|-7.87||||0.2849|TWO_SIDED|90.0|-20.3|4.59|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||4.59|-20.3|0.2849
71710777|NCT03766399|142939198|OTHER||LS means difference|-8.31||||0.2595|TWO_SIDED|90.0|-20.8|4.14|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||4.14|-20.8|0.2595
71710778|NCT03766399|142939198|OTHER||LS means difference|-3.04||||0.3604|TWO_SIDED|90.0|-8.6|2.51|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||2.51|-8.60|0.3604
71710779|NCT03766399|142939199|OTHER||LS means difference|-25.4||||0.7544|TWO_SIDED|90.0|-166.0|115.0|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Cohort 2||115|-166|0.7544
71710780|NCT03766399|142939199|OTHER||LS means difference|-73.3||||0.375|TWO_SIDED|90.0|-214.0|67.6|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 2 Vs Part 2a (MAD) Placebo||67.6|-214|0.3750
71710781|NCT03766399|142939199|OTHER||LS means difference|-98.7||||0.2377|TWO_SIDED|90.0|-240.0|42.3|||Linear Mixed Model|||Comparison of Part 2a (MAD) Cohort 1 Vs Part 2a (MAD) Placebo||42.3|-240|0.2377
71710782|NCT03766399|142939199|OTHER||LS means difference|-50.4||||0.1105|TWO_SIDED|90.0|-102.0|1.61|||Linear Mixed Model|||Comparison of Part 3a (DPI/PoM) Vs Part 3a (DPI/PoM) Placebo||1.61|-102|0.1105
71710783|NCT02014376|142939200|SUPERIORITY||||||=|0.3699|||||||Fisher Exact|||||||=0.3699
71710784|NCT02951481|142939210|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
71710785|NCT02951481|142939211|SUPERIORITY|||||||0.55|TWO_SIDED|95.0|||||Fisher Exact|||||||0.55
71710786|NCT02951481|142939212|SUPERIORITY|||||||0.023|||||||Chi-squared|||||||0.023
71710787|NCT02951481|142939213|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71710788|NCT02951481|142939214|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71710789|NCT02951481|142939215|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71710790|NCT02951481|142939216|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71710791|NCT02951481|142939217|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71710792|NCT01051661|142939218|SUPERIORITY|The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was \> -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was \>0.|Vaccine efficacy increase|76.7|||||TWO_SIDED|95.0|18.53|93.39||||||Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.||93.39|18.53|
71710793|NCT01051661|142939246|OTHER||Adjusted GMT ratios|5.61|||||TWO_SIDED|95.0|4.92|6.41||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).||6.41|4.92|
71710794|NCT01051661|142939246|OTHER||Adjusted GMT ratios|1.05|||||TWO_SIDED|95.0|0.93|1.19||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).||1.19|0.93|
71710795|NCT02412982|142939273|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
71710796|NCT04011241|142939311|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|173.71|||||TWO_SIDED|90.0|154.58|195.21|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 17.6.|||195.21|154.58|
71710797|NCT04011241|142939312|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|137.4|||||TWO_SIDED|90.0|120.84|156.24|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 19.4.|||156.24|120.84|
71710798|NCT04011241|142939313|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|168.64|||||TWO_SIDED|90.0|145.59|195.34|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|Intra-individual geometric coefficient of variation (gCV%) = 18.1.|||195.34|145.59|
71710799|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 1: the ratio of GMT (GMR) (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.92|0.66|
71710800|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.89|||||TWO_SIDED|95.0|0.79|0.99||||||Serotype 3: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.79|
71710801|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||Serotype 4: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.94|0.67|
71710802|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||Serotype 5: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.91|0.65|
71710803|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.87|||||TWO_SIDED|95.0|0.73|1.05||||||Serotype 6A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.05|0.73|
71710804|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.91|||||TWO_SIDED|95.0|0.77|1.08||||||Serotype 6B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.08|0.77|
71710805|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.84|||||TWO_SIDED|95.0|0.75|0.93||||||Serotype 7F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.93|0.75|
71710806|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.88|||||TWO_SIDED|95.0|0.76|1.02||||||Serotype 9V: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.02|0.76|
71710807|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|1.09|||||TWO_SIDED|95.0|0.92|1.29||||||Serotype 14: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.29|0.92|
71710808|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.73|||||TWO_SIDED|95.0|0.62|0.85||||||Serotype 18C: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.85|0.62|
71710809|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.74|||||TWO_SIDED|95.0|0.63|0.86||||||Serotype 19A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.86|0.63|
71765898|NCT04620798|143033847|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.74|1.31|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.31|0.74|
71765899|NCT04620798|143033848|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.84|1.09|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.09|0.84|
71765900|NCT04620798|143033848|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.72|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.72|0.33|
71765901|NCT04620798|143033849|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.74|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.74|
71826817|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.445|STANDARD_ERROR_OF_MEAN|0.208||0.0328|TWO_SIDED|95.0|-0.853|-0.037|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.037|-0.853|0.0328
71826818|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.213||0.3162|TWO_SIDED|95.0|-0.633|0.205|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.205|-0.633|0.3162
71826819|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.353|STANDARD_ERROR_OF_MEAN|0.185||0.0569|TWO_SIDED|95.0|-0.716|0.01|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.010|-0.716|0.0569
71710810|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 19F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.76|0.53|
71710811|NCT04875533|142939325|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/13vPnC)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||Serotype 23F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.99|0.65|
71710812|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|0.58|||||TWO_SIDED|95.0|0.5|0.67||||||Serotype 8: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||0.67|0.50|
71710813|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.14|||||TWO_SIDED|95.0|1.8|2.53||||||Serotype 10A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.53|1.80|
71710814|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.72|||||TWO_SIDED|95.0|1.44|2.06||||||Serotype 11A: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.06|1.44|
71710815|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.68|||||TWO_SIDED|95.0|1.39|2.04||||||Serotype 12F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.04|1.39|
71710816|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|2.13|||||TWO_SIDED|95.0|1.72|2.64||||||Serotype 15B: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||2.64|1.72|
71710817|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.62|||||TWO_SIDED|95.0|1.33|1.98||||||Serotype 22F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.98|1.33|
71710818|NCT04875533|142939326|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the ratio of GMT20vPnC/saline to GMT13vPnC/PPSV23 for that serotype is greater than 0.5 (2-fold criterion).|Ratio of GMTs (20vPnC/PPSV23)|1.14|||||TWO_SIDED|95.0|0.97|1.34||||||Serotype 33F: GMR (the 20vPnC/saline group to the 13vPnC/PPSV23 group) and the 2-sided 95% CI||1.34|0.97|
71710819|NCT00330733|142939373|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student's t tests or Wilcoxon signed rank tests.||||<0.05
71710820|NCT01979185|142939400|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.632|||||TWO_SIDED|90.0|0.538|0.744|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.744|0.538|
71710821|NCT01979185|142939401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.63|||||TWO_SIDED|90.0|0.543|0.73|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.730|0.543|
71710822|NCT01979185|142939402|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.594|||||TWO_SIDED|90.0|0.526|0.672|||Mixed-effects Model|||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||0.672|0.526|
71886737|NCT00523991|143293799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.28|0.14|<0.001
71710823|NCT00980798|142939403|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2365||||0.1212|TWO_SIDED|95.0|-0.5357|0.0627||No adjustment for multiple comparisons necessary, as only 1 primary hypothesis was tested. Threshold for statistical significance was 0.05.|Mixed-model regression analysis|The difference above is presented as the difference OROS hydromorphone HCl minus placebo, so negative scores favour OROS hydromorphone HCl.|The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee.|The F test for treatment tested the null hypothesis of no treatment difference. Assuming that 3 baseline measures and 7 post baseline measures were collected 81 patients were required per group to detect a difference of 1 point in the BPI measure with 90% power at a significance level of 5%. To allow for a drop-out rate of approximately 40%, the study planned to recruit 135 patients per group (i.e. 270 in total).||0.0627|-0.5357|0.1212
71765902|NCT04620798|143033849|SUPERIORITY||Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.6|3.25|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||3.25|0.60|
71710824|NCT04724837|142939405|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-33.7|||<|0.001|TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + Placebo (PBO)||-23.5|-42.5|<0.001
71710825|NCT04724837|142939406|SUPERIORITY|Two-sided p-value is presented. A p-value \<0.10 indicates statistical significance, which is consistent with a one-sided test at the 5% level.|Adjusted % mean change from baseline|-27.0||||0.002|TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|0.002
71710826|NCT04724837|142939407|SUPERIORITY||Least Square (LS) mean CFB|-3.6|||||TWO_SIDED|90.0|-6.8|-0.5|||Mixed Models Analysis||If mean change from baseline (CFB) \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.5|-6.8|
71710827|NCT04724837|142939407|SUPERIORITY||LS mean CFB|-7.6|||||TWO_SIDED|90.0|-10.3|-4.9|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office systolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-4.9|-10.3|
71710828|NCT04724837|142939408|SUPERIORITY||LS Mean CFB|-3.0|||||TWO_SIDED|90.0|-5.0|-1.0|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-1.0|-5.0|
71765903|NCT04620798|143033850|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.03|0.99|
71765904|NCT04620798|143033850|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.77|1.21|||||"This analysis compares the probability of a response of Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.21|0.77|
71765905|NCT04620798|143033851|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.97|1.06|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.06|0.97|
71765906|NCT04620798|143033851|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.6|1.11|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.11|0.60|
71765907|NCT04620798|143033852|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.04|||||"This analysis compares the probability of responding Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.04|0.97|
71765908|NCT04620798|143033852|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||"This analysis compares the probability of a response of Very Often/Always vs. all other response categories. The reference group for this analysis was the control (delayed results) group."|This analysis uses only those participants with a positive antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and behavioral outcomes. The reference group for this analysis was the control (delayed results) group.||1.12|0.74|
71886738|NCT00523991|143293800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||<|0.001||95.0|0.21|0.36||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.36|0.21|<0.001
71710829|NCT04724837|142939408|SUPERIORITY||LS Mean CFB|-5.4|||||TWO_SIDED|90.0|-7.1|-3.7|||Mixed Models Analysis||If mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for office diastolic blood pressure.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-3.7|-7.1|
71710830|NCT04724837|142939409|SUPERIORITY||Adjusted % mean change from baseline|-27.0|||||TWO_SIDED|90.0|-38.4|-13.6|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-13.6|-38.4|
71710831|NCT04724837|142939409|SUPERIORITY||Adjusted % mean change from baseline|-33.7|||||TWO_SIDED|90.0|-42.5|-23.5|||Mixed Models Analysis||If adjusted percentage mean change from baseline \>0 then the result favours Dapa 10 mg + PBO for UACR.|Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-23.5|-42.5|
71710832|NCT04724837|142939410|SUPERIORITY||LS mean CFB|1.1|||||TWO_SIDED|90.0|-0.5|2.6|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||2.6|-0.5|
71765909|NCT04620798|143033853|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.71|||||This analysis compares the probability of seroconverting during the study period. The reference group for this analysis was the control (delayed results) group.|This analysis includes only those participants with a negative antibody test result at baseline to test the association between the treatment condition (immediate vs. delayed test results) and seroconversion. The reference group for this analysis was the control (delayed results) group.||1.71|0.52|
71710833|NCT04724837|142939410|SUPERIORITY||LS mean CFB|-0.8|||||TWO_SIDED|90.0|-2.1|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.1|
71710834|NCT04724837|142939410|SUPERIORITY||LS mean CFB|-1.2|||||TWO_SIDED|90.0|-2.8|0.5|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.5|-2.8|
71710835|NCT04724837|142939410|SUPERIORITY||LS mean CFB|-1.1|||||TWO_SIDED|90.0|-2.5|0.3|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||0.3|-2.5|
71710836|NCT04724837|142939410|SUPERIORITY||LS mean CFB|0.1|||||TWO_SIDED|90.0|-1.6|1.8|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.8|-1.6|
71710837|NCT04724837|142939410|SUPERIORITY||LS mean CFB|-2.1|||||TWO_SIDED|90.0|-3.5|-0.7|||Mixed Models Analysis||If mean change from baseline \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 14 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.7|-3.5|
71710838|NCT04724837|142939412|SUPERIORITY||LS mean change|-2.2|||||TWO_SIDED|90.0|-4.0|-0.4|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and Week 12 - Comparison between Zibotentan 0.25 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||-0.4|-4.0|
71710839|NCT04724837|142939412|SUPERIORITY||LS mean change|-0.3|||||TWO_SIDED|90.0|-1.8|1.3|||Mixed Models Analysis||If mean change \<0 then the result favours Dapa 10 mg + PBO for eGFR.|Week 1 and 12 - Comparison between Zibotentan 1.5 mg + Dapagliflozin and Dapagliflozin 10 mg + PBO||1.3|-1.8|
71710840|NCT00967499|142939442|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||||||0.4010
71765910|NCT01960907|143033866|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|||||||0.342
71765911|NCT01960907|143033867|SUPERIORITY_OR_OTHER|||||||0.915|||||||t-test, 2 sided|||||||0.915
71710841|NCT00967499|142939443|SUPERIORITY|||||||0.5672|||||||Cochran-Mantel-Haenszel|||||||0.5672
71710842|NCT00967499|142939444|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.0570
71710843|NCT00967499|142939445|SUPERIORITY|||||||0.515|||||||Cochran-Mantel-Haenszel|||||||0.5150
71710844|NCT00967499|142939446|SUPERIORITY|||||||0.3601||||||P-values are based on Cochran-Mantel-Haenszel row mean score test with gender adjustment for the ranks of the change from baseline values.|Cochran-Mantel-Haenszel|||||||0.3601
71710845|NCT00967499|142939447|SUPERIORITY|||||||0.3453|||||||Mann-Whitney Test|||24 hours postdose||||0.3453
71710846|NCT00967499|142939447|SUPERIORITY|||||||0.7874|||||||Mann-Whitney Test|||48 hours postdose||||0.7874
71765912|NCT01960907|143033868|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
71765913|NCT00978757|143033878|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71710847|NCT00967499|142939447|SUPERIORITY|||||||0.8485|||||||Mann-Whitney Test|||72 Hours Postdose||||0.8485
71710848|NCT04562090|142939463|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.73|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-4.3|-3.16||Repeated Measures Analysis (RMA): CFB as response, treatment group (TG), visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.16|-4.30|<0.001
71710849|NCT04562090|142939466|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.62|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-3.25|-1.99||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.99|-3.25|<0.001
71710850|NCT04562090|142939466|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.47|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.93|-2.02||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-2.02|-2.93|<0.001
71710851|NCT04562090|142939466|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.96|-2.3||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.30|-3.96|<0.001
71710852|NCT04562090|142939466|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.39|-2.47||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.47|-3.39|<0.001
71765914|NCT01185353|143033908|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori p-value significance threshold: 1-sided ≤0.10|Regression, Logistic|||||||<0.001
71765915|NCT01185353|143033910|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.045
71765916|NCT01185353|143033910|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.088
71710853|NCT04562090|142939466|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.47|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.37|-2.56||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-2.56|-4.37|<0.001
71710854|NCT04562090|142939466|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.59|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-4.06|-3.12||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and interaction between TG and visit as fixed effects and mean (SD) number of grade 3 or 4 (PPIUS) urgency episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-3.12|-4.06|<0.001
71710855|NCT04562090|142939467|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.66|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.88|-0.44||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.44|-0.88|<0.001
71710856|NCT04562090|142939467|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.81|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.97|-0.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.65|-0.97|<0.001
71710857|NCT04562090|142939467|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.17|-0.58||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.58|-1.17|<0.001
71710858|NCT04562090|142939467|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.78||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.78|-1.10|<0.001
71710859|NCT04562090|142939467|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.71||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.71|-1.35|<0.001
71710860|NCT04562090|142939467|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.98|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.14|-0.81||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of daytime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.81|-1.14|<0.001
71710861|NCT04562090|142939468|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.58|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.37|-0.58|<0.001
71710862|NCT04562090|142939468|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.53|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.38|-0.53|<0.001
71710863|NCT04562090|142939468|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.67|-0.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.39|-0.67|<0.001
71710864|NCT04562090|142939468|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.45|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.52|-0.37||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.37|-0.52|<0.001
71710865|NCT04562090|142939468|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.38||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.38|-0.68|<0.001
71710866|NCT04562090|142939468|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.6|-0.45||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of nighttime incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.45|-0.60|<0.001
71710867|NCT04562090|142939469|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-1.31|-0.9||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.90|-1.31|<0.001
71710868|NCT04562090|142939469|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.25|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 4||-0.96|-1.25|<0.001
71710869|NCT04562090|142939469|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.53|-0.99||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-0.99|-1.53|<0.001
71710870|NCT04562090|142939469|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-1.34|-1.05||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 8||-1.05|-1.34|<0.001
71710871|NCT04562090|142939469|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.54|-0.96||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-0.96|-1.54|<0.001
71710872|NCT04562090|142939469|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.42|-1.12||RMA: CFB as response, treatment group, visit (week 4, 8 and 12), pooled site, sex and the interaction between treatment group and visit as fixed effects and mean number of urge incontinence episodes per 24 hours at baseline as covariate.|MMRM|||Week 12||-1.12|-1.42|<0.001
71710873|NCT04562090|142939470|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-3.5|-2.43||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.43|-3.50|<0.001
71710874|NCT04562090|142939470|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.05|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-3.44|-2.65||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 4||-2.65|-3.44|<0.001
71710875|NCT04562090|142939470|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.09|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-5.8|-4.39||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-4.39|-5.80|<0.001
71710876|NCT04562090|142939470|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-4.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-4.7|-3.9||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 8||-3.90|-4.70|<0.001
71710877|NCT04562090|142939470|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-6.01|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-6.78|-5.24||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-5.24|-6.78|<0.001
71765917|NCT01185353|143033910|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
71765918|NCT01185353|143033910|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
71886739|NCT00523991|143293801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.001||95.0|0.23|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.38|0.23|<0.001
71765919|NCT01185353|143033912|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.003
71765920|NCT01185353|143033912|SUPERIORITY_OR_OTHER|||||||0.162|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.162
71765921|NCT01185353|143033912|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
71710878|NCT04562090|142939470|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-5.4|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-5.82|-4.98||RMA: CFB as response, TG, visit (week 4, 8 and 12), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of OABSS at baseline as covariate.|MMRM|||Week 12||-4.98|-5.82|<0.001
71710879|NCT04562090|142939471|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-1.97|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.73|-1.21||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.21|-2.73|<0.001
71765922|NCT01185353|143033912|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
71765923|NCT01185353|143033914|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.017
71765924|NCT01185353|143033914|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||0.109
71765925|NCT01185353|143033914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
71765926|NCT01185353|143033914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact|||||||<0.001
71765927|NCT01185353|143033918|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.480
71765928|NCT01185353|143033918|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.064
71765929|NCT01185353|143033918|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765930|NCT01185353|143033918|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
71765931|NCT01185353|143033918|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.116
71765932|NCT01185353|143033918|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.201
71765933|NCT01185353|143033918|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765934|NCT01185353|143033918|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.002
71765935|NCT01185353|143033920|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.003
71765936|NCT01185353|143033920|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.167
71765937|NCT01185353|143033920|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765938|NCT01185353|143033920|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
71765939|NCT01185353|143033922|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.016
71765940|NCT01185353|143033922|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.108
71765941|NCT01185353|143033922|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
71765942|NCT01185353|143033922|SUPERIORITY_OR_OTHER|||||||0.368|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.368
71765943|NCT01185353|143033924|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.039
71765944|NCT01185353|143033924|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.458
71765945|NCT01185353|143033924|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.008
71765946|NCT01185353|143033924|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.029
71765947|NCT01185353|143033926|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.217
71765948|NCT01185353|143033926|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.092
71765949|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765950|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765951|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765952|NCT01185353|143033926|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.072
71765953|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765954|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765955|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765956|NCT01185353|143033926|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.082
71765957|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765958|NCT01185353|143033926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765959|NCT01185353|143033928|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.024
71765960|NCT01185353|143033928|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.030
71765961|NCT01185353|143033928|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765962|NCT01185353|143033928|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765963|NCT01185353|143033930|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.120
71710880|NCT04562090|142939471|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.36|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.9|-1.81||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 4||-1.81|-2.90|<0.001
71710881|NCT04562090|142939471|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-3.2|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-4.2|-2.2||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.20|-4.20|<0.001
71710882|NCT04562090|142939471|SUPERIORITY|Statistical testing was conducted using 2-sided at a significance level of 0.05.|LS Mean|-2.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-3.47|-2.37||RMA: CFB as response, TG, visit (week 4, 8), pooled site, sex and the interaction between TG and visit as fixed effects and mean number of micturitions per 24 hours at baseline as covariate.|MMRM|||Week 8||-2.37|-3.47|<0.001
71710883|NCT03312543|142939499|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.18|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.09|0.26|||t-test, 2 sided|||||0.26|0.09|<0.001
71710884|NCT03312543|142939499|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.341|<|0.001|TWO_SIDED|95.0|0.21|0.39|||t-test, 2 sided|||||0.39|0.21|<0.001
71710885|NCT03312543|142939499|OTHER|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.025|TWO_SIDED|95.0|0.02|0.25|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.25|0.02|0.025
71710886|NCT03312543|142939500|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.349|<|0.001|TWO_SIDED|95.0|0.11|0.29|||t-test, 2 sided|||||0.29|0.11|<0.001
71710887|NCT03312543|142939500|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.328|<|0.001|TWO_SIDED|95.0|0.13|0.31|||t-test, 2 sided|||||0.31|0.13|<0.001
71710888|NCT03312543|142939500|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.54|TWO_SIDED|95.0|-0.09|0.16|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.16|-0.09|0.540
71710889|NCT03312543|142939501|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.532||0.627|TWO_SIDED|95.0|-0.17|0.1|||t-test, 2 sided|||||0.10|-0.17|0.627
71710890|NCT03312543|142939501|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.21|STANDARD_DEVIATION|0.5||0.002|TWO_SIDED|95.0|0.08|0.34|||t-test, 2 sided|||||0.34|0.08|0.002
71710891|NCT03312543|142939501|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.092||0.009|TWO_SIDED|95.0|0.06|0.42|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.42|0.06|0.009
71765964|NCT01185353|143033930|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||0.012
71710892|NCT03312543|142939502|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.36|STANDARD_DEVIATION|0.465|<|0.001|TWO_SIDED|95.0|0.23|0.48|||t-test, 2 sided|||||0.48|0.23|<0.001
71710893|NCT03312543|142939502|SUPERIORITY|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.47|STANDARD_DEVIATION|0.578|<|0.001|TWO_SIDED|95.0|0.32|0.63|||t-test, 2 sided|||||0.63|0.32|<0.001
71710894|NCT03312543|142939502|EQUIVALENCE|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.094||0.224|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.||||0.30|-0.07|0.224
71710895|NCT05535972|142939534|OTHER||Least Square Mean|-6.81|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-7.28|-6.33|||||CFB in CAT score was analyzed using Mixed Model Repeated Measures(MMRM) model with covariates of smoking status, CAT score at Baseline, visit, interaction of CAT score at Baseline\*visit. Estimates derived from inverse probability weighted MMRM model.|||-6.33|-7.28|
71710896|NCT04197583|142939550|OTHER||Proportion by group|0.984|||||TWO_SIDED|95.0|0.948|0.995|||||For Tria subjects with stone management indication only|||0.995|0.948|
71710897|NCT00323622|142939581|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|16.8||||0.08|TWO_SIDED|95.0|-2.5|32.4||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.40|-2.50|0.08
71765965|NCT01185353|143033930|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
71710898|NCT00323622|142939581|SUPERIORITY_OR_OTHER||1 - (HR1/HR2)|11.8||||0.43|TWO_SIDED|95.0|-20.11|35.18||The p-value presented is the Wald Chi-square p-value from the Cox regression model|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||35.18|-20.11|0.43
71710899|NCT00323622|142939582|SUPERIORITY_OR_OTHER||1 - (R1/R2)|14.9||||0.11|TWO_SIDED|95.0|-3.88|30.28||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||30.28|-3.88|0.11
71710900|NCT00323622|142939582|SUPERIORITY_OR_OTHER||1 - (R1/R2)|12.79||||0.35|TWO_SIDED|95.0|-16.27|34.59||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||34.59|-16.27|0.35
71710901|NCT00323622|142939583|SUPERIORITY_OR_OTHER||1 - (R1/R2)|19.42||||0.01|TWO_SIDED|95.0|4.62|31.93||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||31.93|4.62|0.01
71710902|NCT00323622|142939583|SUPERIORITY_OR_OTHER||1 - (R1/R2)|7.08||||0.54|TWO_SIDED|95.0|-17.37|26.44||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||26.44|-17.37|0.54
71710903|NCT00323622|142939584|SUPERIORITY_OR_OTHER||1 - (R1/R2)|16.79||||0.1|TWO_SIDED|95.0|-3.75|33.25||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||33.25|-3.75|0.10
71710904|NCT00323622|142939584|SUPERIORITY_OR_OTHER||1 - (R1/R2)|6.31||||0.7|TWO_SIDED|95.0|-31.0|32.99||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 - (minus) \[Hazard Ratio (HR) in Cohort 1 - RTS,S/AS02A Group \[HR1\]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group \[HR2\])\], i. e. 1 - (HR1/HR2).||32.99|-31.00|0.70
71710905|NCT04191135|142939618|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4556|TWO_SIDED|95.0|0.72|1.33||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.33|0.72|0.4556
71710906|NCT04191135|142939619|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3903|TWO_SIDED|95.0|0.64|1.4||One-sided p-value based on log-rank test stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|Log Rank||Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.40|0.64|0.3903
71710907|NCT04191135|142939620|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.59|1.43|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.43|0.59|
71710908|NCT04191135|142939621|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.53|1.76|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and BRCA status (BRCAm versus BRCAwt).|||1.76|0.53|
71765966|NCT01185353|143033930|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel|||||||<0.001
71765967|NCT01185353|143033932|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.409
71765968|NCT01185353|143033932|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.371
71765969|NCT01185353|143033932|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
71765970|NCT01185353|143033932|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.007
71765971|NCT01185353|143033932|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.033
71765972|NCT01185353|143033932|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.019
71765973|NCT01185353|143033932|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||<0.001
71765974|NCT01185353|143033932|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact|||||||0.001
71826820|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.449|STANDARD_ERROR_OF_MEAN|0.18||0.0126|TWO_SIDED|95.0|-0.801|-0.096|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.096|-0.801|0.0126
71765975|NCT01185353|143033934|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.015
71655505|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.13|STANDARD_ERROR_OF_MEAN|3.2064|||TWO_SIDED|95.0|-12.5|0.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.2|-12.5|
71765976|NCT01185353|143033934|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.073
71765977|NCT01185353|143033934|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71655506|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.88|STANDARD_ERROR_OF_MEAN|3.4032|||TWO_SIDED|95.0|-10.6|2.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.6|
71655507|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.67|STANDARD_ERROR_OF_MEAN|3.3393|||TWO_SIDED|95.0|-13.3|0.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.0|-13.3|
71655508|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|3.5727|||TWO_SIDED|95.0|-8.9|5.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.3|-8.9|
71655509|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.43|STANDARD_ERROR_OF_MEAN|3.1554|||TWO_SIDED|95.0|-10.7|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.8|-10.7|
71765978|NCT01185353|143033934|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765979|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.021
71826821|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.515|STANDARD_ERROR_OF_MEAN|0.208||0.0135|TWO_SIDED|95.0|-0.923|-0.107|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||-0.107|-0.923|0.0135
71710909|NCT04191135|142939622|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.33|1.48|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||1.48|0.33|
71710910|NCT04191135|142939623|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.28|2.37|||||Estimate based on stratified Cox model with Efron's method of tie handling with treatment as a covariate stratified by response to the induction therapy (CR or PR versus SD) and tumor PD-L1 status (CPS≥1 vs CPS\<1).|||2.37|0.28|
71710911|NCT04191135|142939624|SUPERIORITY||Difference in Least Squares Means|-3.28||||0.143|TWO_SIDED|95.0|-7.69|1.12|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||1.12|-7.69|0.1430
71710912|NCT04191135|142939625|SUPERIORITY||Difference in Least Squares Means|-0.16||||0.9454|TWO_SIDED|95.0|-4.89|4.56|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.56|-4.89|0.9454
71710913|NCT04191135|142939626|SUPERIORITY||Difference in Least Squares Means|2.08||||0.4351|TWO_SIDED|95.0|-3.16|7.31|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||7.31|-3.16|0.4351
71710914|NCT04191135|142939627|SUPERIORITY||Difference in Least Squares Means|0.93||||0.5588|TWO_SIDED|95.0|-2.2|4.06|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||4.06|-2.20|0.5588
71710915|NCT04191135|142939628|SUPERIORITY||Difference in Least Squares Means|-0.37||||0.8408|TWO_SIDED|95.0|-4.03|3.28|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.28|-4.03|0.8408
71710916|NCT04191135|142939629|SUPERIORITY||Difference in Least Squares Means|-1.34||||0.795|TWO_SIDED|95.0|-11.63|8.95|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||8.95|-11.63|0.7950
71710917|NCT04191135|142939630|SUPERIORITY||Difference in Least Squares Means|4.82||||0.1597|TWO_SIDED|95.0|-1.97|11.62|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||11.62|-1.97|0.1597
71710918|NCT04191135|142939631|SUPERIORITY||Difference in Least Squares Means|2.52||||0.6138|TWO_SIDED|95.0|-7.45|12.49|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.49|-7.45|0.6138
71710919|NCT04191135|142939632|SUPERIORITY||Difference in Least Squares Means|-1.6||||0.5567|TWO_SIDED|95.0|-7.02|3.83|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||3.83|-7.02|0.5567
71710920|NCT04191135|142939633|SUPERIORITY||Difference in Least Squares Means|5.56||||0.105|TWO_SIDED|95.0|-1.2|12.32|||cLDA|cLDA model with PRO scores as the response variable with covariates for treatment by time interaction, stratification factors as covariates.||||12.32|-1.20|0.1050
71710921|NCT04191135|142939634|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.00676|TWO_SIDED|95.0|1.16|2.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||2.71|1.16|0.00676
71710922|NCT04191135|142939635|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96425|TWO_SIDED|95.0|0.61|1.69|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.69|0.61|0.96425
71710923|NCT04191135|142939636|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.74965|TWO_SIDED|95.0|0.69|1.71|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||1.71|0.69|0.74965
71710924|NCT04191135|142939637|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.10502|TWO_SIDED|95.0|0.88|3.53|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and BRCA Status (BRCAm versus wild type BRCA gene).|||3.53|0.88|0.10502
71710925|NCT04191135|142939638|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.5019|TWO_SIDED|95.0|0.57|3.0|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||3.00|0.57|0.50190
71710926|NCT04191135|142939639|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.47384|TWO_SIDED|95.0|0.24|1.97|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||1.97|0.24|0.47384
71710927|NCT04191135|142939640|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.81463|TWO_SIDED|95.0|0.33|2.38|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||2.38|0.33|0.81463
71710928|NCT04191135|142939641|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.67255|TWO_SIDED|95.0|0.24|8.82|||Log Rank|Stratified log-rank test|Estimate via stratified Cox model with Efron's handling method with treatment as a covariate stratified by response to the induction therapy (CR/PR versus SD), and tumor PD-L1 status (CPS ≥1 vs CPS \<1).|||8.82|0.24|0.67255
71710929|NCT03514134|142939644|SUPERIORITY||||||<|0.001|||||||ANCOVA|Repeated measures ANCOVA||||||<0.001
71710930|NCT03514134|142939645|SUPERIORITY|||||||0.358|||||||ANCOVA|Repeated measures ANCOVA||||||0.358
71710931|NCT03514134|142939646|SUPERIORITY|||||||0.029|||||||ANCOVA|Repeated measures ANCOVA||||||0.029
71710932|NCT03514134|142939647|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71710933|NCT03514134|142939647|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
71826822|NCT00383188|143158063|SUPERIORITY||LSM Difference|-0.145|STANDARD_ERROR_OF_MEAN|0.213||0.4979|TWO_SIDED|95.0|-0.564|0.274|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.274|-0.564|0.4979
71826823|NCT00383188|143158063|SUPERIORITY||LSM Difference|0.271|STANDARD_ERROR_OF_MEAN|0.195||0.1643|TWO_SIDED|95.0|-0.111|0.653|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.653|-0.111|0.1643
71710934|NCT03514134|142939648|SUPERIORITY|||||||0.7||||||Group by time interaction|ANOVA|Repeated measures ANOVA||||||0.70
71710935|NCT02471144|142939649|SUPERIORITY||Odds Ratio (OR)|25.78|||<|0.0001|TWO_SIDED|95.0|7.08|114.66|||Regression, Logistic|||vs Placebo||114.66|7.08|<.0001
71710936|NCT02471144|142939649|SUPERIORITY||Odds Ratio (OR)|22.65|||<|0.0001|TWO_SIDED|95.0|6.31|98.93|||Regression, Logistic|||vs Placebo||98.93|6.31|<.0001
71710937|NCT02471144|142939650|SUPERIORITY||Odds Ratio (OR)|51.77|||<|0.0001|TWO_SIDED|95.0|10.02|538.64|||Regression, Logistic|||vs Placebo||538.64|10.02|<.0001
71710938|NCT02471144|142939650|SUPERIORITY||Odds Ratio (OR)|32.52|||<|0.0001||95.0|6.48|329.52|||Regression, Logistic|||vs Placebo||329.52|6.48|<.0001
71710939|NCT02471144|142939651|SUPERIORITY||Odds Ratio (OR)|72.5|||<|0.0001|TWO_SIDED|95.0|55.9|84.9|||Regression, Logistic|||vs Placebo||84.9|55.9|<.0001
71710940|NCT02471144|142939651|SUPERIORITY||Odds Ratio (OR)|67.5|||<|0.0001|TWO_SIDED|95.0|50.8|80.9|||Regression, Logistic|||vs Placebo||80.9|50.8|<.0001
71765980|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.194
71765981|NCT01185353|143033935|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71886740|NCT00523991|143293802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.25|0.4||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.40|0.25|<0.001
71710941|NCT00107575|142939669|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>.05
71710942|NCT00107575|142939670|SUPERIORITY_OR_OTHER||expected count ratio|0.81||||0.027|TWO_SIDED|95.0|0.67|0.98||a priori p-value was p \< .05|generalized estimating equations|Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking||||0.98|0.67|.027
71710943|NCT00107575|142939671|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||.18
71710944|NCT00107575|142939672|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||||||.95
71765982|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.012
71710945|NCT00107575|142939673|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Chi-squared|||||||.76
71710946|NCT03977155|142939677|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.35||0.3776|TWO_SIDED|95.0|-1.0|0.38|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.38|-1.00|0.3776
71710947|NCT03977155|142939677|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.73|0.82||||||Statistical Analysis 2||0.82|-0.73|
71710948|NCT03977155|142939677|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.403|||TWO_SIDED|95.0|-1.41|0.19||||||Statistical Analysis 3||0.19|-1.41|
71710949|NCT03977155|142939677|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.13|1.44||||||Statistical Analysis 4||1.44|-0.13|
71710950|NCT03977155|142939679|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.211||0.884|TWO_SIDED|95.0|-0.45|0.39|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.39|-0.45|0.8840
71710951|NCT03977155|142939679|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.249|||TWO_SIDED|95.0|-0.6|0.39||||||Statistical Analysis 2||0.39|-0.60|
71710952|NCT03977155|142939679|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.43|0.49||||||Statistical Analysis 3||0.49|-0.43|
71710953|NCT03977155|142939679|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|-0.63|0.36||||||Statistical Analysis 4||0.36|-0.63|
71765983|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.449
71765984|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.578
71765985|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.140
71765986|NCT01185353|143033935|SUPERIORITY_OR_OTHER|||||||0.266|TWO_SIDED|||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.266
71826824|NCT00383188|143158063|SUPERIORITY||LSM Difference|0.081|STANDARD_ERROR_OF_MEAN|0.185||0.6611|TWO_SIDED|95.0|-0.282|0.445|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.445|-0.282|0.6611
71826825|NCT00383188|143158063|SUPERIORITY||LSM Difference|0.097|STANDARD_ERROR_OF_MEAN|0.219||0.6587|TWO_SIDED|95.0|-0.333|0.526|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.526|-0.333|0.6587
71710954|NCT03977155|142939680|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.228||0.4725|TWO_SIDED|95.0|-0.62|0.29|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.29|-0.62|0.4725
71710955|NCT03977155|142939680|SUPERIORITY||Median Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|95.0|-0.71|0.31||||||Statistical Analysis 2||0.31|-0.71|
71710956|NCT03977155|142939680|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.62|0.37||||||Statistical Analysis 3||0.37|-0.62|
71710957|NCT03977155|142939680|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|95.0|-0.6|0.45||||||Statistical Analysis 4||0.45|-0.60|
71710958|NCT03977155|142939681|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5693|TWO_SIDED|95.0|-0.28|0.51|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.51|-0.28|0.5693
71710959|NCT03977155|142939681|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|-0.35|0.63||||||Statistical Analysis 2||0.63|-0.35|
71710960|NCT03977155|142939681|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.33|0.51||||||Statistical Analysis 3||0.51|-0.33|
71710961|NCT03977155|142939681|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.41|0.51||||||Statistical Analysis 4||0.51|-0.41|
71710962|NCT03977155|142939682|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-7.71|STANDARD_ERROR_OF_MEAN|25.208||0.7603|TWO_SIDED|95.0|-57.76|42.33|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||42.33|-57.76|0.7603
71710963|NCT03977155|142939682|SUPERIORITY||Mean Difference (Net)|24.0|STANDARD_ERROR_OF_MEAN|29.087|||TWO_SIDED|95.0|-34.22|82.22||||||Statistical Analysis 2||82.22|-34.22|
71710964|NCT03977155|142939682|SUPERIORITY||Mean Difference (Net)|-33.42|STANDARD_ERROR_OF_MEAN|27.285|||TWO_SIDED|95.0|-87.91|21.07||||||Statistical Analysis 3||21.07|-87.91|
71765987|NCT01185353|143033936|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|A priori p-value significance threshold: 2-sided ≤0.10.||||||0.005
71765988|NCT01185353|143033936|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.135
71765989|NCT01185353|143033936|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||<0.001
71765990|NCT01185353|143033936|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.001
71710965|NCT03977155|142939682|SUPERIORITY||Mean Difference (Net)|57.42|STANDARD_ERROR_OF_MEAN|28.174|||TWO_SIDED|95.0|1.16|113.69||||||Statistical Analysis 4||113.69|1.16|
71765991|NCT01185353|143033937|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.203
71710966|NCT03977155|142939683|SUPERIORITY|Individual BOS-589 dose levels versus placebo were only to be tested if pooled BOS-589 doses versus placebo was significant at p\<0.05.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.2149|TWO_SIDED|95.0|-0.44|0.1|||t test|P-values were calculated from the independent two-sample t test with equal variance.||Statistical Analysis 1||0.10|-0.44|0.2149
71710967|NCT03977155|142939683|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.27|0.29||||||Statistical Analysis 2||0.29|-0.27|
71710968|NCT03977155|142939683|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.64|-0.01||||||Statistical Analysis 3||-0.01|-0.64|
71710969|NCT03977155|142939683|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.02|0.65||||||Statistical Analysis 4||0.65|0.02|
71710970|NCT00775658|142939688|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.||||0.57
71710971|NCT00775658|142939689|SUPERIORITY|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71765992|NCT01185353|143033937|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.164
71765993|NCT01185353|143033937|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.018
71765994|NCT01185353|143033937|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA|||||||0.097
71826826|NCT00383188|143158063|SUPERIORITY||LSM Difference|0.154|STANDARD_ERROR_OF_MEAN|0.223||0.4903|TWO_SIDED|95.0|-0.284|0.592|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline DAS28-4(CRP) as the covariate; and participant as a random effect.||0.592|-0.284|0.4903
71710972|NCT05796245|142939729|OTHER|Estimation|Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.39|5.2|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.20|0.39|
71710973|NCT05796245|142939729|OTHER|Estimation|Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.38|5.34|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||5.34|0.38|
71710974|NCT05796245|142939729|OTHER|Estimation|Risk Difference (RD)|0.04|||||TWO_SIDED|95.0|-0.2|0.11|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.11|-0.20|
71710975|NCT05796245|142939729|OTHER|Estimation|Cox Proportional Hazard|1.63|||||TWO_SIDED|95.0|0.54|4.9|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||4.90|0.54|
71826827|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.119|STANDARD_ERROR_OF_MEAN|0.09||0.1857|TWO_SIDED|95.0|-0.296|0.057|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.057|-0.296|0.1857
71655510|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.6161|||TWO_SIDED|95.0|-6.4|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.4|
71655511|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.35|STANDARD_ERROR_OF_MEAN|3.1849|||TWO_SIDED|95.0|-8.7|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-8.7|
71655512|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.78|STANDARD_ERROR_OF_MEAN|3.7688|||TWO_SIDED|95.0|-10.3|4.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-10.3|
71655513|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.857|||TWO_SIDED|95.0|-7.0|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.4|-7.0|
71655514|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-6.91|STANDARD_ERROR_OF_MEAN|3.1527|||TWO_SIDED|95.0|-13.2|-0.07|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-.07|-13.2|
71655515|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-4.22|STANDARD_ERROR_OF_MEAN|3.3457|||TWO_SIDED|95.0|-10.9|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.4|-10.9|
71655516|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.61|STANDARD_ERROR_OF_MEAN|3.2806|||TWO_SIDED|95.0|-10.1|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.9|-10.1|
71655517|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|3.5078|||TWO_SIDED|95.0|-7.8|6.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.2|-7.8|
71655518|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|3.0965|||TWO_SIDED|95.0|-6.2|6.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||6.1|-6.2|
71710976|NCT05796245|142939729|OTHER|Estimation|Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|0.55|5.26|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||5.26|0.55|
71765995|NCT02270944|143033941|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.79|1.32|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.32|0.79|
71765996|NCT02270944|143033942|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.76|1.3|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes III when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.30|0.76|
71765997|NCT02270944|143033943|NON_INFERIORITY|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be \> 0.5 and the upper limit of the two-sided 95% CI must be \< 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.72|1.22|||ANCOVA|Analysis of covariance (ANCOVA) model with vaccine group and center as fixed effects and log10-prevaccination antibody concentration as a covariate||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).||1.22|0.72|
71765998|NCT00095147|143033947|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-1.04|||<|0.001|TWO_SIDED|95.0|-1.42|-0.67|||ANCOVA|||The primary analysis was the comparison of abatacept versus placebo for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.67|-1.42|<0.001
71765999|NCT00095147|143033948|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.77|||<|0.001|TWO_SIDED|95.0|-1.14|-0.39|||ANCOVA|||Infliximab versus placebo were compared for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.39|-1.14|<0.001
71766000|NCT00095147|143033950|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|20.6||||0.001|TWO_SIDED|95.0|7.7|33.6|||Chi-squared, Corrected|||Comparisons were made between ABA and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||33.6|7.7|0.001
71886741|NCT00523991|143293803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||<|0.001||95.0|0.26|0.45||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.45|0.26|<0.001
71655519|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-1.05|STANDARD_ERROR_OF_MEAN|2.5649|||TWO_SIDED|95.0|-6.1|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-6.1|
71655520|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-2.59|STANDARD_ERROR_OF_MEAN|3.125|||TWO_SIDED|95.0|-8.8|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.7|-8.8|
71655521|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.84|STANDARD_ERROR_OF_MEAN|3.7013|||TWO_SIDED|95.0|-11.2|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.5|-11.2|
71655522|NCT02037165|142829272|SUPERIORITY_OR_OTHER||adjusted mean difference|-3.05|STANDARD_ERROR_OF_MEAN|2.8201|||TWO_SIDED|95.0|-8.7|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.6|-8.7|
71826828|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.277|STANDARD_ERROR_OF_MEAN|0.089||0.0019|TWO_SIDED|95.0|-0.451|-0.103|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.103|-0.451|0.0019
71710977|NCT05796245|142939729|OTHER|Estimation|Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.39|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.39|-0.10|
71710978|NCT05796245|142939729|OTHER|Estimation|Cox Proportional Hazard|2.44|||||TWO_SIDED|95.0|1.05|5.67|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.67|1.05|
71710979|NCT05796245|142939729|OTHER|Estimation|Risk Ratio (RR)|2.47|||||TWO_SIDED|95.0|1.02|5.99|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||5.99|1.02|
71710980|NCT05796245|142939729|OTHER|Estimation|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.06|0.32|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.32|-0.06|
71710981|NCT05796245|142939730|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.01|0.0|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the Comparative analysis set (IPTW weighted) and for the Comparative matched analysis set could not be calculated. Also, crude hazard ratio and crude risk ratio could not be calculated.||0.00|-0.01|
71710982|NCT05796245|142939731|OTHER|Estimation|Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.12|12.49|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||12.49|0.12|
71710983|NCT05796245|142939731|OTHER|Estimation|Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.12|17.14|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.14|0.12|
71766001|NCT00095147|143033950|SUPERIORITY_OR_OTHER||Estimate of difference from placebo|17.9||||0.005|TWO_SIDED|95.0|5.1|30.7|||Chi-squared, Corrected|||Comparisons were made between INF and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.||30.7|5.1|0.005
71766002|NCT00095147|143033952|SUPERIORITY_OR_OTHER||Difference from placebo|-0.38|||<|0.001|TWO_SIDED|95.0|-0.53|-0.23|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.23|-0.53|<0.001
71766003|NCT00095147|143033952|SUPERIORITY_OR_OTHER||Difference from placebo|-0.3|||<|0.001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||-0.15|-0.45|<0.001
71766004|NCT00095147|143033954|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|4.02|||<|0.001|TWO_SIDED|95.0|1.92|6.12|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||6.12|1.92|<0.001
71710984|NCT05796245|142939731|OTHER|Estimation|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.05|0.01|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.01|-0.05|
71826829|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.244|STANDARD_ERROR_OF_MEAN|0.103||0.0178|TWO_SIDED|95.0|-0.446|-0.042|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.042|-0.446|0.0178
71826830|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.098|STANDARD_ERROR_OF_MEAN|0.106||0.3547|TWO_SIDED|95.0|-0.305|0.11|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.110|-0.305|0.3547
71710985|NCT05796245|142939731|OTHER|Estimation|Cox Proportional Hazard|6.12|||||TWO_SIDED|95.0|0.81|45.94|||||Crude Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set Note: Hazard ratio, risk ratio, and risk difference for the comparative matched analysis set could not be calculated.||45.94|0.81|
71710986|NCT05796245|142939731|OTHER|Estimation|Risk Ratio (RR)|7.07|||||TWO_SIDED|95.0|0.93|53.51|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||53.51|0.93|
71710987|NCT05796245|142939731|OTHER|Estimation|Risk Difference (RD)|0.03|||||TWO_SIDED|95.0|-0.04|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.04|
71710988|NCT05796245|142939732|OTHER|Estimation|Cox Proportional Hazard|1.7|||||TWO_SIDED|95.0|0.16|17.61|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||17.61|0.16|
71710989|NCT05796245|142939732|OTHER|Estimation|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.17|19.79|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||19.79|0.17|
71710990|NCT05796245|142939732|OTHER|Estimation|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-0.12|0.03|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.03|-0.12|
71710991|NCT05796245|142939732|OTHER|Estimation|Cox Proportional Hazard|2.61|||||TWO_SIDED|95.0|0.15|45.68|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||45.68|0.15|
71710992|NCT05796245|142939732|OTHER|Estimation|Risk Ratio (RR)|2.01|||||TWO_SIDED|95.0|0.12|34.94|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||34.94|0.12|
71710993|NCT05796245|142939732|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.1|0.26|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.26|-0.10|
71710994|NCT05796245|142939732|OTHER|Estimation|Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|0.37|19.93|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.93|0.37|
71710995|NCT05796245|142939732|OTHER|Estimation|Risk Ratio (RR)|2.66|||||TWO_SIDED|95.0|0.37|19.31|||||Crude Risk Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||19.31|0.37|
71710996|NCT05796245|142939732|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.10|-0.05|
71710997|NCT05796245|142939733|OTHER|Estimation|Cox Proportional Hazard|0.18|||||TWO_SIDED|95.0|0.02|1.85|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.85|0.02|
71710998|NCT05796245|142939733|OTHER|Estimation|Risk Ratio (RR)|0.19|||||TWO_SIDED|95.0|0.02|1.99|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||1.99|0.02|
71710999|NCT05796245|142939733|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.17|0.0|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set, IPTW weighted||0.00|-0.17|
71711000|NCT05796245|142939733|OTHER|Estimation|Cox Proportional Hazard|0.63|||||TWO_SIDED|95.0|0.07|6.0|||||Hazard Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.00|0.07|
71711001|NCT05796245|142939733|OTHER|Estimation|Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.08|6.61|||||Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||6.61|0.08|
71711002|NCT05796245|142939733|OTHER|Estimation|Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.1|0.21|||||Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative matched analysis set||0.21|-0.10|
71711003|NCT05796245|142939733|OTHER|Estimation|Cox Proportional Hazard|2.07|||||TWO_SIDED|95.0|0.28|15.22|||||Crude Hazard Ratio Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.22|0.28|
71711004|NCT05796245|142939733|OTHER|Estimation|Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.29|15.08|||||Crude Risk Ratio of Exposed/Reference, where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||15.08|0.29|
71711005|NCT05796245|142939733|OTHER|Estimation|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.05|0.09|||||Crude Risk Difference (Exposed-Reference), where Exposed is Infliximab-Pfizer Biosimilar and Reference is Remicade.|Comparative analysis set||0.09|-0.05|
71711006|NCT04999267|142939734|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71711007|NCT04999267|142939735|OTHER|Pre-intervention vs. Post-intervention analysis|||||<|0.0001|||||||Chi-squared|||||||<.0001
71711008|NCT03257657|142939782|OTHER|||||||0.1|||||||t-test, 2 sided|||||||0.1
71711009|NCT03257657|142939784|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71711010|NCT03257657|142939786|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71711011|NCT02296099|142939794|EQUIVALENCE|The Mann-Whitney U test was utilized.||||||0.014||||||The p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|There were no adjustments.||The null hypothesis is that there is no difference in the pain scores between the two groups.||||0.014
71711012|NCT00688740|142939820|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.795||||0.0043|TWO_SIDED|95.0|0.679|0.932||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.932|0.679|0.0043
71711013|NCT00688740|142939821|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.742||||0.002|TWO_SIDED|95.0|0.613|0.898||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank|||||0.898|0.613|0.0020
71711014|NCT00856557|142939824|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is equal distribution of proportion of successful encounters among groups||||0.33
71711015|NCT00856557|142939824|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.724|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED||||||Mixed Models Analysis|||Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)||||.036
71711016|NCT00856557|142939825|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.99
71711017|NCT00856557|142939826|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.39
71711018|NCT01432444|142939827|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value was derived from Exact McNemar test.|McNemar|||Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.||||<.0001
71711019|NCT01432444|142939828|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, 12 and 24.||||<.0001
71711020|NCT01432444|142939829|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, Week 12 and Week 24.||||<.0001
71711021|NCT01432444|142939830|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analysis for Week 4, 12 and 24.||||<.0001
71711022|NCT01432444|142939831|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Derived from t-test of mean=0.|t-test|||Statistical analysEs for Week 4, 12 and 24.||||<.0001
71711023|NCT02301897|142939833|SUPERIORITY|||||||0.0008|||||||Chi-Square Test|||||||0.0008
71711024|NCT02301897|142939833|SUPERIORITY||||||<|0.001|||||||Chi-Square Test|||||||<0.001
71711025|NCT02301897|142939834|SUPERIORITY|||||||0.0719|||||||Chi-Square Test|||||||0.0719
71711026|NCT02301897|142939834|SUPERIORITY|||||||0.0004|||||||Chi-Square Test|||||||0.0004
71711027|NCT02301897|142939835|SUPERIORITY|||||||0.0167|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.0167
71711028|NCT02301897|142939835|SUPERIORITY|||||||0.1257|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1||||0.1257
71711029|NCT02301897|142939835|SUPERIORITY|||||||0.9754|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.9754
71711030|NCT02301897|142939835|SUPERIORITY|||||||0.7672|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1||||0.7672
71711031|NCT02301897|142939835|SUPERIORITY|||||||0.2232|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.2232
71711032|NCT02301897|142939835|SUPERIORITY|||||||0.4512|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2||||0.4512
71711033|NCT02301897|142939835|SUPERIORITY|||||||0.3545|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.3545
71711034|NCT02301897|142939835|SUPERIORITY|||||||0.2482|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU||||0.2482
71711035|NCT02301897|142939836|SUPERIORITY|||||||0.0016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0016
71711036|NCT02301897|142939836|SUPERIORITY|||||||0.0003|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0003
71886742|NCT00523991|143293810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.927||95.0|-0.38|0.41||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and albuterol use at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.41|-0.38|0.927
71886743|NCT00523991|143293811|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.174
71711037|NCT02301897|142939836|SUPERIORITY|||||||0.6666|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.6666
71711038|NCT02301897|142939836|SUPERIORITY|||||||0.3612|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1||||0.3612
71711039|NCT02301897|142939836|SUPERIORITY|||||||0.0309|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0309
71711040|NCT02301897|142939836|SUPERIORITY|||||||0.0007|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0007
71711041|NCT02301897|142939836|SUPERIORITY|||||||0.0641|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.0641
71711042|NCT02301897|142939836|SUPERIORITY|||||||0.3743|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU||||0.3743
71711043|NCT02301897|142939837|SUPERIORITY|||||||0.0049|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0049
71711044|NCT02301897|142939837|SUPERIORITY|||||||0.0064|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0064
71711045|NCT02301897|142939837|SUPERIORITY|||||||0.5637|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5637
71711046|NCT02301897|142939837|SUPERIORITY|||||||0.0505|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0505
71711047|NCT02301897|142939837|SUPERIORITY|||||||0.4262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4262
71711048|NCT02301897|142939837|SUPERIORITY|||||||0.1419|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1419
71711049|NCT02301897|142939837|SUPERIORITY|||||||0.4497|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4497
71711050|NCT02301897|142939837|SUPERIORITY|||||||0.5371|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5371
71711051|NCT02301897|142939838|SUPERIORITY|||||||0.0069|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0069
71711052|NCT02301897|142939838|SUPERIORITY|||||||0.0059|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0059
71711053|NCT02301897|142939838|SUPERIORITY|||||||0.2117|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2117
71711054|NCT02301897|142939838|SUPERIORITY|||||||0.0006|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0006
71711055|NCT02301897|142939838|SUPERIORITY|||||||0.0788|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0788
71711056|NCT02301897|142939838|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0080
71711057|NCT02301897|142939838|SUPERIORITY|||||||0.1516|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1516
71711058|NCT02301897|142939838|SUPERIORITY|||||||0.0565|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.0565
71711059|NCT02301897|142939839|SUPERIORITY|||||||0.011|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0110
71711060|NCT02301897|142939839|SUPERIORITY|||||||0.0601|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0601
71711061|NCT02301897|142939839|SUPERIORITY|||||||0.2168|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2168
71711062|NCT02301897|142939839|SUPERIORITY|||||||0.0101|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0101
71711063|NCT02301897|142939839|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2430
71711064|NCT02301897|142939839|SUPERIORITY|||||||0.0843|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0843
71711065|NCT02301897|142939839|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
71711066|NCT02301897|142939839|SUPERIORITY|||||||0.5302|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5302
71711067|NCT02301897|142939840|SUPERIORITY|||||||0.0504|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0504
71711068|NCT02301897|142939840|SUPERIORITY|||||||0.0151|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0151
71711069|NCT02301897|142939840|SUPERIORITY|||||||0.5932|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5932
71711070|NCT02301897|142939840|SUPERIORITY|||||||0.0831|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0831
71711071|NCT02301897|142939840|SUPERIORITY|||||||0.1416|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1416
71711072|NCT02301897|142939840|SUPERIORITY|||||||0.0392|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0392
71711073|NCT02301897|142939840|SUPERIORITY|||||||0.8275|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8275
71711074|NCT02301897|142939840|SUPERIORITY|||||||0.8733|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8733
71711075|NCT02301897|142939841|SUPERIORITY|||||||0.0651|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0651
71711076|NCT02301897|142939841|SUPERIORITY|||||||0.0298|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0298
71711077|NCT02301897|142939841|SUPERIORITY|||||||0.4005|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4005
71711078|NCT02301897|142939841|SUPERIORITY|||||||0.1114|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.1114
71711079|NCT02301897|142939841|SUPERIORITY|||||||0.1318|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1318
71711080|NCT02301897|142939841|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
71711081|NCT02301897|142939841|SUPERIORITY|||||||0.4506|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4506
71711082|NCT02301897|142939841|SUPERIORITY|||||||0.4614|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.4614
71766005|NCT00095147|143033954|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|3.51||||0.004|TWO_SIDED|95.0|1.1|5.91|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.91|1.10|0.004
71711083|NCT02301897|142939842|SUPERIORITY|||||||0.0653|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0653
71711084|NCT02301897|142939842|SUPERIORITY|||||||0.048|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0480
71711085|NCT02301897|142939842|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.4010
71711086|NCT02301897|142939842|SUPERIORITY|||||||0.0772|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0772
71766006|NCT00095147|143033954|SUPERIORITY_OR_OTHER||Difference from placebo (PCS)|3.32||||0.002|TWO_SIDED|95.0|1.25|5.4|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.40|1.25|0.002
71886744|NCT00523991|143293812|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.186
71711087|NCT02301897|142939842|SUPERIORITY|||||||0.3206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.3206
71711088|NCT02301897|142939842|SUPERIORITY|||||||0.1605|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.1605
71711089|NCT02301897|142939842|SUPERIORITY|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.5570
71711090|NCT02301897|142939842|SUPERIORITY|||||||0.3437|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.3437
71711091|NCT02301897|142939843|SUPERIORITY|||||||0.2624|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2624
71711092|NCT02301897|142939843|SUPERIORITY|||||||0.0688|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0688
71711093|NCT02301897|142939843|SUPERIORITY|||||||0.279|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2790
71711094|NCT02301897|142939843|SUPERIORITY|||||||0.6541|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6541
71711095|NCT02301897|142939843|SUPERIORITY|||||||0.8559|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.8559
71711096|NCT02301897|142939843|SUPERIORITY|||||||0.4326|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4326
71711097|NCT02301897|142939843|SUPERIORITY|||||||0.1052|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.1052
71711098|NCT02301897|142939843|SUPERIORITY|||||||0.9206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.9206
71711099|NCT02301897|142939844|SUPERIORITY|||||||0.1439|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1439
71711100|NCT02301897|142939844|SUPERIORITY|||||||0.067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0670
71711101|NCT02301897|142939844|SUPERIORITY|||||||0.6761|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.6761
71711102|NCT02301897|142939844|SUPERIORITY|||||||0.0639|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0639
71711103|NCT02301897|142939844|SUPERIORITY|||||||0.2218|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2218
71711104|NCT02301897|142939844|SUPERIORITY|||||||0.4468|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.4468
71711105|NCT02301897|142939844|SUPERIORITY|||||||0.7678|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7678
71711106|NCT02301897|142939844|SUPERIORITY|||||||0.8922|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8922
71711107|NCT02301897|142939845|SUPERIORITY|||||||0.1262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.1262
71711108|NCT02301897|142939845|SUPERIORITY|||||||0.2075|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.2075
71711109|NCT02301897|142939845|SUPERIORITY|||||||0.5904|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.5904
71711110|NCT02301897|142939845|SUPERIORITY|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.2430
71711111|NCT02301897|142939845|SUPERIORITY|||||||0.7067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.7067
71711112|NCT02301897|142939845|SUPERIORITY|||||||0.2725|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.2725
71711113|NCT02301897|142939845|SUPERIORITY|||||||0.7016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.7016
71711114|NCT02301897|142939845|SUPERIORITY|||||||0.8751|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU||||0.8751
71711115|NCT02301897|142939846|SUPERIORITY|||||||0.0338|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0338
71711116|NCT02301897|142939846|SUPERIORITY|||||||0.0004|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1||||0.0004
71711117|NCT02301897|142939846|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0807
71711118|NCT02301897|142939846|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2||||0.0142
71711119|NCT02301897|142939846|SUPERIORITY|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0807
71711120|NCT02301897|142939846|SUPERIORITY|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2||||0.0142
71711121|NCT02301897|142939846|SUPERIORITY|||||||0.1859|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.1859
71711122|NCT02301897|142939846|SUPERIORITY|||||||0.0896|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug||||0.0896
71711123|NCT00023595|142939864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.12|TWO_SIDED|95.0|0.72|1.04|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.04|0.72|0.12
71711124|NCT00023595|142939865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.02
71711125|NCT00023595|142939866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.17|0.84|0.90
71766007|NCT00095147|143033954|SUPERIORITY_OR_OTHER||Difference from placebo (MCS)|2.68||||0.027|TWO_SIDED|95.0|0.31|5.05|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.||5.05|0.31|0.027
71766008|NCT02390791|143034018|SUPERIORITY|||||||0.04|||||||generalized linear model|assuming a Poisson distribution with a log link function||||||0.04
71886745|NCT00523991|143293813|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.045
71886746|NCT00523991|143293814|SUPERIORITY_OR_OTHER|||||||0.223||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.223
71711126|NCT00023595|142939867|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio, log|0.79||||0.006|TWO_SIDED|95.0|0.66|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.66|0.006
71711127|NCT00023595|142939868|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.05|TWO_SIDED|95.0|0.66|1.0|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.00|0.66|0.05
71711128|NCT00023595|142939869|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.64|0.85|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.85|0.64|<0.001
71711129|NCT00023595|142939870|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.64|0.82|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.82|0.64|<0.001
71711130|NCT00023595|142939871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.26|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.26|0.79|0.98
71711131|NCT00023595|142939872|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.19||||0.008|TWO_SIDED|95.0|1.35|7.52|||Regression, Logistic||Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||7.52|1.35|0.008
71711132|NCT00023595|142939873|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.275|TWO_SIDED|95.0|0.78|2.41|||Regression, Logistic||Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||2.41|0.78|0.275
71711133|NCT00023595|142939874|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.03|TWO_SIDED|95.0|0.71|0.98|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.98|0.71|0.030
71711134|NCT00023595|142939875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.401|TWO_SIDED|95.0|0.89|1.31|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.31|0.89|0.401
71711135|NCT00023595|142939876|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.93|0.71|0.002
71711136|NCT00023595|142939892|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.001|TWO_SIDED|95.0|0.51|0.71|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.71|0.51|<0.001
71711137|NCT00023595|142939893|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.414|TWO_SIDED|95.0|0.73|1.13|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.13|0.73|0.414
71711138|NCT00023595|142939894|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.55|0.73|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.73|0.55|<0.001
71711139|NCT00023595|142939895|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.108|TWO_SIDED|95.0|0.72|1.03|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||1.03|0.72|0.108
71711140|NCT00023595|142939896|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.717|TWO_SIDED|95.0|0.83|1.32|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)|||1.32|0.83|0.717
71711141|NCT00023595|142939897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.018|TWO_SIDED|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)|||0.97|0.73|0.018
71711142|NCT00023595|142939913|SUPERIORITY|||||||0.015||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.015
71711143|NCT00023595|142939913|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71711144|NCT00023595|142939913|SUPERIORITY|||||||0.011||||||24 months|Chi-squared|||||||0.011
71711145|NCT00023595|142939913|SUPERIORITY|||||||0.44||||||36 months|Chi-squared|||||||0.44
71711146|NCT00023595|142939914|SUPERIORITY|||||||0.91||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.91
71711147|NCT00023595|142939914|SUPERIORITY|||||||0.62||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.62
71711148|NCT00023595|142939914|SUPERIORITY|||||||0.04||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.04
71711149|NCT00023595|142939914|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71711150|NCT00023595|142939914|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71826831|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.135|STANDARD_ERROR_OF_MEAN|0.089||0.1301|TWO_SIDED|95.0|-0.31|0.04|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.040|-0.310|0.1301
71711151|NCT00023595|142939915|SUPERIORITY|||||||0.31||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.31
71711152|NCT00023595|142939915|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71711153|NCT00023595|142939915|SUPERIORITY|24 months||||||0.028|||||||Chi-squared|||||||0.028
71711154|NCT00023595|142939915|SUPERIORITY|||||||0.079||||||36 months|Chi-squared|||||||0.079
71711155|NCT00023595|142939916|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
71711156|NCT00023595|142939916|SUPERIORITY|||||||0.61||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.61
71711157|NCT00023595|142939916|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71886747|NCT00523991|143293815|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.010
71711158|NCT00023595|142939916|SUPERIORITY|||||||0.94||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.94
71711159|NCT00023595|142939916|SUPERIORITY|||||||0.29||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.29
71711160|NCT00023595|142939917|SUPERIORITY|||||||0.063||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.063
71711161|NCT00023595|142939917|SUPERIORITY|||||||0.187||||||12 months|Chi-squared|||||||0.187
71711162|NCT00023595|142939917|SUPERIORITY|||||||0.168||||||24 months|Chi-squared|||||||0.168
71711163|NCT00023595|142939917|SUPERIORITY|||||||0.05||||||36 months|Chi-squared|||||||0.050
71711164|NCT00023595|142939918|SUPERIORITY|||||||0.82||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.82
71711165|NCT00023595|142939918|SUPERIORITY|||||||0.48||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.48
71711166|NCT00023595|142939918|SUPERIORITY|||||||0.69||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.69
71711167|NCT00023595|142939918|SUPERIORITY|||||||0.63||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.63
71711168|NCT00023595|142939918|SUPERIORITY|||||||0.9||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.90
71711169|NCT00023595|142939919|SUPERIORITY|||||||0.039||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.039
71711170|NCT00023595|142939919|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71711171|NCT00023595|142939919|SUPERIORITY|||||||0.008||||||24 months|Chi-squared|||||||0.008
71711172|NCT00023595|142939919|SUPERIORITY|||||||0.31||||||36 months|Chi-squared|||||||0.31
71711173|NCT00023595|142939920|SUPERIORITY|||||||0.36||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.36
71711174|NCT00023595|142939920|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
71711175|NCT00023595|142939920|SUPERIORITY|||||||0.17||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.17
71711176|NCT00023595|142939920|SUPERIORITY|||||||0.12||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.12
71711177|NCT00023595|142939920|SUPERIORITY|||||||0.79||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.79
71711178|NCT00023595|142939921|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|||||||<0.001
71711179|NCT00023595|142939921|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71711180|NCT00023595|142939921|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71711181|NCT00023595|142939921|SUPERIORITY||||||<|0.024||||||36 months|Chi-squared|||||||<0.024
71711182|NCT00023595|142939922|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
71711183|NCT00023595|142939922|SUPERIORITY|||||||0.42||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.42
71711184|NCT00023595|142939922|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
71711185|NCT00023595|142939922|SUPERIORITY|||||||0.32||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.32
71711186|NCT00023595|142939922|SUPERIORITY|||||||0.43||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.43
71711187|NCT00023595|142939923|SUPERIORITY|||||||0.051||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.051
71711188|NCT00023595|142939923|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
71711189|NCT00023595|142939923|SUPERIORITY|||||||0.065||||||24 months|Chi-squared|||||||0.065
71711190|NCT00023595|142939923|SUPERIORITY|||||||0.83||||||36 months|Chi-squared|||||||0.83
71711191|NCT00023595|142939924|SUPERIORITY|||||||0.71||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.71
71711192|NCT00023595|142939924|SUPERIORITY|||||||0.57||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.57
71711193|NCT00023595|142939924|SUPERIORITY|||||||0.15||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.15
71711194|NCT00023595|142939924|SUPERIORITY|||||||0.64||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.64
71711195|NCT00023595|142939924|SUPERIORITY|||||||0.07||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.07
71711196|NCT00023595|142939925|SUPERIORITY|||||||0.004||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.004
71711197|NCT00023595|142939925|SUPERIORITY|||||||0.011||||||12 months|Chi-squared|||||||0.011
71711198|NCT00023595|142939925|SUPERIORITY|||||||0.007||||||24 months|Chi-squared|||||||0.007
71711199|NCT00023595|142939925|SUPERIORITY|||||||0.044||||||36 months|Chi-squared|||||||0.044
71711200|NCT00023595|142939926|SUPERIORITY|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.74
71826832|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0313|TWO_SIDED|95.0|-0.363|-0.017|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.017|-0.363|0.0313
71886748|NCT00523991|143293816|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.086
71711201|NCT00023595|142939926|SUPERIORITY|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.87
71711202|NCT00023595|142939926|SUPERIORITY|||||||0.03||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.03
71711203|NCT00023595|142939926|SUPERIORITY|||||||0.6||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.60
71711204|NCT00023595|142939926|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
71711205|NCT00023595|142939927|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
71711206|NCT00023595|142939927|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
71711207|NCT00023595|142939927|SUPERIORITY|24 months||||||0.049|||||||Chi-squared|||||||0.049
71711208|NCT00023595|142939927|SUPERIORITY|||||||0.097||||||36 months|Chi-squared|||||||0.097
71711209|NCT00023595|142939928|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
71711210|NCT00023595|142939928|SUPERIORITY|||||||0.13||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.13
71711211|NCT00023595|142939928|SUPERIORITY|||||||0.86||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.86
71766009|NCT02390791|143034019|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71766010|NCT02390791|143034020|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
71711212|NCT00023595|142939928|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
71711213|NCT00023595|142939928|SUPERIORITY|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.87
71711214|NCT00023595|142939929|SUPERIORITY|||||||0.005||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.005
71711215|NCT00023595|142939929|SUPERIORITY|||||||0.023||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.023
71711216|NCT00023595|142939929|SUPERIORITY|||||||0.009||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.009
71711217|NCT00023595|142939929|SUPERIORITY|||||||0.26||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.26
71711218|NCT00023595|142939930|SUPERIORITY|||||||0.38||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.38
71711219|NCT00023595|142939930|SUPERIORITY|||||||0.45||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.45
71711220|NCT00023595|142939930|SUPERIORITY|||||||0.62||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.62
71711221|NCT00023595|142939930|SUPERIORITY|||||||0.82||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.82
71711222|NCT00023595|142939930|SUPERIORITY|||||||0.94||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.94
71711223|NCT00023595|142939931|SUPERIORITY|||||||0.205||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.205
71711224|NCT00023595|142939931|SUPERIORITY|||||||0.017||||||12 months|Chi-squared|||||||0.017
71711225|NCT00023595|142939931|SUPERIORITY|||||||0.028||||||24 months|Chi-squared|||||||0.028
71711226|NCT00023595|142939931|SUPERIORITY|||||||0.123||||||36 months|Chi-squared|||||||0.123
71711227|NCT00023595|142939932|SUPERIORITY|||||||0.19||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.19
71711228|NCT00023595|142939932|SUPERIORITY|||||||0.07||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.07
71711229|NCT00023595|142939932|SUPERIORITY|||||||0.94||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.94
71711230|NCT00023595|142939932|SUPERIORITY|||||||0.67||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.67
71711231|NCT00023595|142939932|SUPERIORITY|||||||0.44||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.44
71711232|NCT00023595|142939933|SUPERIORITY|||||||0.05||||||4 months|Chi-squared|P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.050
71711233|NCT00023595|142939933|SUPERIORITY|||||||0.006||||||12 months|Chi-squared|||||||0.006
71711234|NCT00023595|142939933|SUPERIORITY|||||||0.039||||||24 months|Chi-squared|||||||0.039
71711235|NCT00023595|142939933|SUPERIORITY|||||||0.074||||||36 months|Chi-squared|||||||0.074
71711236|NCT00023595|142939934|SUPERIORITY|||||||0.23||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.23
71711237|NCT00023595|142939934|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
71711238|NCT00023595|142939934|SUPERIORITY|||||||0.35||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.35
71711239|NCT00023595|142939934|SUPERIORITY|||||||0.9||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.90
71711240|NCT00023595|142939934|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
71711241|NCT00023595|142939935|SUPERIORITY|||||||0.085||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.085
71711242|NCT00023595|142939935|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
71711243|NCT00023595|142939935|SUPERIORITY|||||||0.026||||||24 months|Chi-squared|||||||0.026
71711244|NCT00023595|142939935|SUPERIORITY|||||||0.085||||||36 months|Chi-squared|||||||0.085
71711245|NCT00023595|142939936|SUPERIORITY|||||||0.18||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.18
71711246|NCT00023595|142939936|SUPERIORITY|||||||0.17||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.17
71711247|NCT00023595|142939936|SUPERIORITY|||||||0.59||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.59
71711248|NCT00023595|142939936|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
71711249|NCT00023595|142939936|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
71711250|NCT00023595|142939937|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71711251|NCT00023595|142939937|SUPERIORITY||||||<|0.001||||||12 month|Chi-squared|||||||<0.001
71766011|NCT02390791|143034021|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71766012|NCT02390791|143034022|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71766013|NCT02390791|143034023|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71766014|NCT02390791|143034024|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71766015|NCT02390791|143034025|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
71766016|NCT02390791|143034026|SUPERIORITY|||||||0.48|||||||generalized linear model|||||||0.48
71766017|NCT02390791|143034027|SUPERIORITY|||||||0.71|||||||generalized linear model|||||||0.71
71711252|NCT00023595|142939937|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71711253|NCT00023595|142939937|SUPERIORITY|||||||0.018||||||36 months|Chi-squared|||||||0.018
71711254|NCT00023595|142939938|SUPERIORITY|||||||0.7||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.70
71711255|NCT00023595|142939938|SUPERIORITY|||||||0.47||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.47
71711256|NCT00023595|142939938|SUPERIORITY|||||||0.87||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.87
71711257|NCT00023595|142939938|SUPERIORITY|||||||0.84||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.84
71711258|NCT00023595|142939938|SUPERIORITY|||||||0.82||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.82
71711259|NCT00023595|142939939|SUPERIORITY|||||||0.023||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.023
71711260|NCT00023595|142939939|SUPERIORITY|||||||0.001||||||12 months|Chi-squared|||||||0.001
71711261|NCT00023595|142939939|SUPERIORITY|||||||0.077||||||24 months|Chi-squared|||||||0.077
71711262|NCT00023595|142939939|SUPERIORITY|||||||0.17||||||36 months|Chi-squared|||||||0.170
71711263|NCT00023595|142939940|SUPERIORITY|||||||0.63||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.63
71711264|NCT00023595|142939940|SUPERIORITY|||||||0.29||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.29
71711265|NCT00023595|142939940|SUPERIORITY|||||||0.68||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.68
71711266|NCT00023595|142939940|SUPERIORITY|||||||0.25||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.25
71711267|NCT00023595|142939940|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
71711268|NCT00023595|142939941|SUPERIORITY|||||||0.033||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.033
71711269|NCT00023595|142939941|SUPERIORITY|||||||0.002||||||12 months|Chi-squared|||||||0.002
71711270|NCT00023595|142939941|SUPERIORITY|||||||0.015||||||24 months|Chi-squared|||||||0.015
71711271|NCT00023595|142939941|SUPERIORITY|||||||0.051||||||36 months|Chi-squared|||||||0.051
71711272|NCT00023595|142939942|SUPERIORITY|||||||0.26||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.26
71711273|NCT00023595|142939942|SUPERIORITY|||||||0.23||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.23
71711274|NCT00023595|142939942|SUPERIORITY|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.66
71711275|NCT00023595|142939942|SUPERIORITY|||||||0.98||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.98
71711276|NCT00023595|142939942|SUPERIORITY|||||||0.86||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.86
71711277|NCT00023595|142939943|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71711278|NCT00023595|142939943|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71711279|NCT00023595|142939943|SUPERIORITY|||||||0.006||||||24 months|Chi-squared|||||||0.006
71711280|NCT00023595|142939943|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
71711281|NCT00023595|142939944|SUPERIORITY|||||||0.53||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.53
71711282|NCT00023595|142939944|SUPERIORITY|||||||0.26||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.26
71711283|NCT00023595|142939944|SUPERIORITY|||||||0.76||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.76
71711284|NCT00023595|142939944|SUPERIORITY|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.89
71711285|NCT00023595|142939944|SUPERIORITY|||||||0.89||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.89
71711286|NCT00023595|142939945|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71711287|NCT00023595|142939945|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71711288|NCT00023595|142939945|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71711289|NCT00023595|142939945|SUPERIORITY|||||||0.01||||||36 months|Chi-squared|||||||0.010
71711290|NCT00023595|142939946|SUPERIORITY|||||||0.01||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.01
71711291|NCT00023595|142939946|SUPERIORITY|||||||0.74||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.74
71711292|NCT00023595|142939946|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
71711293|NCT00023595|142939946|SUPERIORITY|||||||0.46||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.46
71711294|NCT00023595|142939946|SUPERIORITY|||||||0.27||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.27
71711295|NCT00023595|142939947|SUPERIORITY|||||||0.029||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.029
71711296|NCT00023595|142939947|SUPERIORITY|||||||0.042||||||12 months|Chi-squared|||||||0.042
71711297|NCT00023595|142939947|SUPERIORITY|||||||0.3||||||24 months|Chi-squared|||||||0.30
71711298|NCT00023595|142939947|SUPERIORITY|||||||0.2||||||36 months|Chi-squared|||||||0.20
71711299|NCT00023595|142939948|SUPERIORITY|||||||0.98||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.98
71711300|NCT00023595|142939948|SUPERIORITY|||||||0.16||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.16
71711301|NCT00023595|142939948|SUPERIORITY|||||||0.88||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.88
71711302|NCT00023595|142939948|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
71711303|NCT00023595|142939948|SUPERIORITY|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.48
71711304|NCT00023595|142939949|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71711305|NCT00023595|142939949|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71711306|NCT00023595|142939949|SUPERIORITY||||||<|0.001||||||24 months|Chi-squared|||||||<0.001
71711307|NCT00023595|142939949|SUPERIORITY|||||||0.001||||||36 months|Chi-squared|||||||0.001
71711308|NCT00023595|142939950|SUPERIORITY|||||||0.86||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.86
71711309|NCT00023595|142939950|SUPERIORITY|||||||0.39||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.39
71711310|NCT00023595|142939950|SUPERIORITY|||||||0.65||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.65
71711311|NCT00023595|142939950|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
71711312|NCT00023595|142939950|SUPERIORITY|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.68
71655523|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.78|STANDARD_ERROR_OF_MEAN|2.5753|||TWO_SIDED|95.0|-8.9|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.3|-8.9|
71655524|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.74|STANDARD_ERROR_OF_MEAN|2.5162|||TWO_SIDED|95.0|-9.8|0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.3|-9.8|
71655525|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.06|STANDARD_ERROR_OF_MEAN|2.9156|||TWO_SIDED|95.0|-11.9|-0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-0.3|-11.9|
71655526|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.83|STANDARD_ERROR_OF_MEAN|3.4987|||TWO_SIDED|95.0|-13.8|0.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||0.1|-13.8|
71655527|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|STANDARD_ERROR_OF_MEAN|3.6922|||TWO_SIDED|95.0|-12.6|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.1|-12.6|
71655528|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.71|STANDARD_ERROR_OF_MEAN|3.6166|||TWO_SIDED|95.0|-11.9|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-11.9|
71655529|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.09|STANDARD_ERROR_OF_MEAN|3.7073|||TWO_SIDED|95.0|-10.5|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.3|-10.5|
71655530|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.82|STANDARD_ERROR_OF_MEAN|4.186|||TWO_SIDED|95.0|-12.1|4.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.5|-12.1|
71655531|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.67|STANDARD_ERROR_OF_MEAN|3.4254|||TWO_SIDED|95.0|-9.5|4.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.1|-9.5|
71711313|NCT00023595|142939951|SUPERIORITY||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||<0.001
71655532|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.5461|||TWO_SIDED|95.0|-8.7|1.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||1.4|-8.7|
71655533|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.46|STANDARD_ERROR_OF_MEAN|2.4848|||TWO_SIDED|95.0|-7.4|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-7.4|
71655534|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.27|STANDARD_ERROR_OF_MEAN|2.8811|||TWO_SIDED|95.0|-9.0|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||2.5|-9.0|
71655535|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.91|STANDARD_ERROR_OF_MEAN|3.4569|||TWO_SIDED|95.0|-9.8|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.0|-9.8|
71655536|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.27|STANDARD_ERROR_OF_MEAN|3.6471|||TWO_SIDED|95.0|-7.0|7.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.5|-7.0|
71655537|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.27|STANDARD_ERROR_OF_MEAN|3.5708|||TWO_SIDED|95.0|-9.4|4.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.8|-9.4|
71655538|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.21|STANDARD_ERROR_OF_MEAN|3.6602|||TWO_SIDED|95.0|-11.5|3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.1|-11.5|
71655539|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|4.1389|||TWO_SIDED|95.0|-7.7|8.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||8.8|-7.7|
71711314|NCT00023595|142939951|SUPERIORITY||||||<|0.001||||||12 months|Chi-squared|||||||<0.001
71711315|NCT00023595|142939951|SUPERIORITY|||||||0.001||||||24 months|Chi-squared|||||||0.001
71711316|NCT00023595|142939951|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71711317|NCT00023595|142939952|SUPERIORITY|||||||0.96||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.96
71711318|NCT00023595|142939952|SUPERIORITY|||||||0.53||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.53
71711319|NCT00023595|142939952|SUPERIORITY|||||||0.37||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.37
71711320|NCT00023595|142939952|SUPERIORITY|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.78
71711321|NCT00023595|142939952|SUPERIORITY|||||||0.21||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.21
71711322|NCT00023595|142939953|SUPERIORITY|||||||0.007||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.007
71711323|NCT00023595|142939953|SUPERIORITY|||||||0.003||||||12 months|Chi-squared|||||||0.003
71711324|NCT00023595|142939953|SUPERIORITY|||||||0.023||||||24 months|Chi-squared|||||||0.023
71826833|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
71826834|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.105||0.6318|TWO_SIDED|95.0|-0.256|0.156|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.156|-0.256|0.6318
71655540|NCT02037165|142829273|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|3.3835|||TWO_SIDED|95.0|-8.8|4.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||4.7|-8.8|
71655541|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-29.67|STANDARD_ERROR_OF_MEAN|29.5691|||TWO_SIDED|95.0|-88.3|29.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.0|-88.3|
71655542|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-16.29|STANDARD_ERROR_OF_MEAN|29.8613|||TWO_SIDED|95.0|-75.5|42.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||42.9|-75.5|
71826835|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.055|STANDARD_ERROR_OF_MEAN|0.089||0.5388|TWO_SIDED|95.0|-0.23|0.12|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.120|-0.230|0.5388
71826836|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.157|STANDARD_ERROR_OF_MEAN|0.088||0.0755|TWO_SIDED|95.0|-0.329|0.016|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.016|-0.329|0.0755
71655543|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|7.63|STANDARD_ERROR_OF_MEAN|25.1035|||TWO_SIDED|95.0|-42.2|57.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||57.5|-42.2|
71655544|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-20.47|STANDARD_ERROR_OF_MEAN|23.311|||TWO_SIDED|95.0|-66.7|25.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||25.8|-66.7|
71711325|NCT00023595|142939953|SUPERIORITY|||||||0.06||||||36 months|Chi-squared|||||||0.060
71711326|NCT00023595|142939954|SUPERIORITY|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.31
71711327|NCT00023595|142939954|SUPERIORITY|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.43
71711328|NCT00023595|142939954|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
71711329|NCT00023595|142939954|SUPERIORITY|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.95
71711330|NCT00023595|142939954|SUPERIORITY|||||||0.38||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.38
71711331|NCT00023595|142939955|SUPERIORITY|||||||0.86||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.86
71711332|NCT00023595|142939955|SUPERIORITY|||||||0.78||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.78
71711333|NCT00023595|142939955|SUPERIORITY|||||||0.55||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.55
71711334|NCT00023595|142939955|SUPERIORITY|||||||0.027||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.027
71711335|NCT00023595|142939955|SUPERIORITY|||||||0.031||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.031
71711336|NCT00023595|142939956|SUPERIORITY|||||||0.4||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.40
71711337|NCT00023595|142939956|SUPERIORITY|||||||0.42||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.42
71711338|NCT00023595|142939956|SUPERIORITY|||||||0.41||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.41
71826837|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.219|STANDARD_ERROR_OF_MEAN|0.102||0.0323|TWO_SIDED|95.0|-0.42|-0.019|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.019|-0.420|0.0323
71711339|NCT00023595|142939956|SUPERIORITY|||||||0.25||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
71711340|NCT00023595|142939956|SUPERIORITY|||||||0.25||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.||||||0.25
71711341|NCT00023595|142939957|SUPERIORITY|||||||0.002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.002
71711342|NCT00023595|142939957|SUPERIORITY|||||||0.007||||||12 months|Chi-squared|||||||0.007
71711343|NCT00023595|142939957|SUPERIORITY|||||||0.049||||||24 months|Chi-squared|||||||0.049
71711344|NCT00023595|142939957|SUPERIORITY|||||||0.038||||||36 months|Chi-squared|||||||0.038
71711345|NCT00023595|142939958|SUPERIORITY|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.40
71711346|NCT00023595|142939958|SUPERIORITY|||||||0.37||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.37
71711347|NCT00023595|142939958|SUPERIORITY|||||||0.98||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.98
71711348|NCT00023595|142939958|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
71711349|NCT00023595|142939958|SUPERIORITY|||||||0.04||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.04
71711350|NCT00023595|142939959|SUPERIORITY|||||||0.036||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.036
71711351|NCT00023595|142939959|SUPERIORITY|||||||0.043||||||12 months|Chi-squared|||||||0.043
71711352|NCT00023595|142939959|SUPERIORITY|||||||0.018||||||24 months|Chi-squared|||||||0.018
71711353|NCT00023595|142939959|SUPERIORITY|||||||0.037||||||36 months|Chi-squared|||||||0.037
71711354|NCT00023595|142939960|SUPERIORITY|||||||0.75||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.75
71711355|NCT00023595|142939960|SUPERIORITY|||||||0.72||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.72
71711356|NCT00023595|142939960|SUPERIORITY|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.77
71711357|NCT00023595|142939960|SUPERIORITY|||||||0.52||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.52
71711358|NCT00023595|142939960|SUPERIORITY|||||||0.12||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.12
71711359|NCT00023595|142939961|SUPERIORITY|||||||0.0002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.||||||0.0002
71711360|NCT00023595|142939961|SUPERIORITY||||||<|0.0001||||||12 months|Chi-squared|||||||<0.0001
71711361|NCT00023595|142939961|SUPERIORITY|||||||0.009||||||24 months|Chi-squared|||||||0.009
71711362|NCT00023595|142939961|SUPERIORITY|||||||0.32||||||36 months|Chi-squared|||||||0.32
71711363|NCT00023595|142939962|SUPERIORITY|||||||0.6||||||Baseline|Wilcoxon (Mann-Whitney)|||||||0.60
71711364|NCT00023595|142939962|SUPERIORITY|||||||0.14||||||4 months|Wilcoxon (Mann-Whitney)|||||||0.14
71711365|NCT00023595|142939962|SUPERIORITY|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)|||||||0.57
71711366|NCT00023595|142939962|SUPERIORITY|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)|||||||0.15
71711367|NCT00023595|142939962|SUPERIORITY|||||||0.84||||||36 months|Wilcoxon (Mann-Whitney)|||||||0.84
71711368|NCT00023595|142939963|SUPERIORITY||||||<|0.0001||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||<0.0001
71711369|NCT00023595|142939963|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
71711370|NCT00023595|142939963|SUPERIORITY||||||<|0.0001||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||<0.0001
71711371|NCT00023595|142939964|SUPERIORITY|||||||0.006||||||Hospital costs|Wilcoxon (Mann-Whitney)|||||||0.006
71711372|NCT00023595|142939964|SUPERIORITY||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)|||||||<0.0001
71711373|NCT00023595|142939964|SUPERIORITY|||||||0.004||||||Total index cost|Wilcoxon (Mann-Whitney)|||||||0.004
71711374|NCT01472185|142939965|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.36||P-value is from a mixed effects model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.36|-0.76|< 0.0001
71711375|NCT00635050|142939979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|||||||||||||
71711376|NCT00086515|142939988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C||||-0.53|-0.77|<0.001
71711377|NCT00086515|142939989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|||<|0.001|TWO_SIDED|95.0|-31.0|-19.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG||||-19.8|-31.0|<0.001
71711378|NCT00086515|142939990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.6|||<|0.001|TWO_SIDED|95.0|-60.5|-40.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG||||-40.8|-60.5|<0.001
71826838|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.072|STANDARD_ERROR_OF_MEAN|0.105||0.4948|TWO_SIDED|95.0|-0.277|0.134|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.134|-0.277|0.4948
71826839|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.089||0.5022|TWO_SIDED|95.0|-0.115|0.235|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.235|-0.115|0.5022
71711379|NCT00049543|142939991|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.14|TWO_SIDED|95.0|0.94|1.64|||Log Rank|||The Kaplan-Meier estimates of survival distribution for overall survival by treatment arm are reported, and the log rank test stratified by the stratification factors at randomization (exclude center) was used to compare the difference in the overall survival between two treatment arms. Hazard ratio of comparison of study treatment arm to placebo and it 95% C.I. were reported.||1.64|0.94|0.14
71711380|NCT00049543|142939992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.15|TWO_SIDED|95.0|0.93|1.61||Stratified by stratification factors at randomization (except center)|Log Rank|Stratified by stratification factors at randomization (except center)||||1.61|0.93|0.15
71711381|NCT02106832|142939994|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7062||||0.0511|TWO_SIDED|99.9|0.3928|1.2698|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2698|0.3928|0.0511
71711382|NCT02106832|142940002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8662||||0.3965|TWO_SIDED|95.1|0.6206|1.209|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.2090|0.6206|0.3965
71711383|NCT00265122|142940014|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||The P-Value is from a Cochran-Mantel-Haenszel (CMH) test stratified by the route of administration.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference between ustekinumab and placebo at a significant level of 0.05.||||0.337
71711384|NCT00265122|142940016|SUPERIORITY_OR_OTHER|||||||0.292||95.0||||The P-Value is from a CMH test stratified by the route of administration.|Cochran-Mantel-Haenszel|||||||0.292
71711385|NCT00608062|142940018|OTHER|Repeated measurements of FMD were modeled using a general linear mixed model with maximum likelihood estimation. An unstructured covariance structure allowing for heterogeneity in the parameter estimate for each level of menopause stage was chosen for the model based on using AIC to compare various covariance structures.||||||0.05|||||||Mixed Models Analysis|||||||0.05
71711386|NCT00608062|142940020|OTHER|Similar analyses as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
71711387|NCT00608062|142940021|OTHER|same analysis as primary outcome||||||0.05|||||||Mixed Models Analysis|||||||0.05
71711388|NCT04992065|142940027|SUPERIORITY||Treatment difference|-31.95|||<|0.0001|TWO_SIDED|95.0|-43.02|-20.87|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-20.87|-43.02|<.0001
71711389|NCT04992065|142940027|SUPERIORITY||Treatment difference|-44.91|||<|0.0001|TWO_SIDED|95.0|-56.04|-33.79|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-33.79|-56.04|<.0001
71711390|NCT04992065|142940027|SUPERIORITY||Treatment difference|-61.83|||<|0.0001|TWO_SIDED|95.0|-72.94|-50.72|||ANCOVA|||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||-50.72|-72.94|<.0001
71711391|NCT04992065|142940027|SUPERIORITY||Treatment difference|33.32|||||TWO_SIDED|95.0|22.16|44.47||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||44.47|22.16|
71826840|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.088||0.0307|TWO_SIDED|95.0|-0.363|-0.018|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.018|-0.363|0.0307
71711392|NCT04992065|142940027|SUPERIORITY||Treatment difference|20.35|||||TWO_SIDED|95.0|9.21|31.48||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||31.48|9.21|
71711393|NCT04992065|142940027|SUPERIORITY||Treatment difference|3.43|||||TWO_SIDED|95.0|-7.81|14.68||||||LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.||14.68|-7.81|
71711394|NCT00663260|142940036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1448||0.561|TWO_SIDED|95.0|-0.37|0.2||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.20|-0.37|0.561
71711395|NCT00663260|142940036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1457||0.435|TWO_SIDED|95.0|-0.4|0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||0.17|-0.40|0.435
71711396|NCT00663260|142940037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|8.142|||TWO_SIDED|95.0|-29.7|2.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||2.4|-29.7|
71711397|NCT00663260|142940037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|8.136|||TWO_SIDED|95.0|-25.0|7.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||7.0|-25.0|
71711398|NCT00663260|142940038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.4435|||TWO_SIDED|95.0|-2.68|-0.94||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-0.94|-2.68|
71826841|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.102||0.0933|TWO_SIDED|95.0|-0.372|0.029|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.029|-0.372|0.0933
71826842|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.027|STANDARD_ERROR_OF_MEAN|0.105||0.7967|TWO_SIDED|95.0|-0.179|0.233|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.233|-0.179|0.7967
71826843|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.089||0.7059|TWO_SIDED|95.0|-0.208|0.141|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.141|-0.208|0.7059
71826844|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.213|STANDARD_ERROR_OF_MEAN|0.088||0.0154|TWO_SIDED|95.0|-0.386|-0.041|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||-0.041|-0.386|0.0154
71826845|NCT00383188|143158065|SUPERIORITY||LSM Difference|-0.136|STANDARD_ERROR_OF_MEAN|0.102||0.1836|TWO_SIDED|95.0|-0.336|0.065|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.065|-0.336|0.1836
71826846|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.078|STANDARD_ERROR_OF_MEAN|0.105||0.4577|TWO_SIDED|95.0|-0.128|0.284|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.284|-0.128|0.4577
71886749|NCT00523991|143293818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.729||95.0|-2.97|4.24||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||4.24|-2.97|0.729
71655545|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-12.63|STANDARD_ERROR_OF_MEAN|23.1894|||TWO_SIDED|95.0|-58.6|33.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||33.4|-58.6|
71655546|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|23.7285|||TWO_SIDED|95.0|-47.8|46.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||46.5|-47.8|
71655547|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-19.27|STANDARD_ERROR_OF_MEAN|27.6359|||TWO_SIDED|95.0|-74.3|35.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||35.7|-74.3|
71655548|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-25.23|STANDARD_ERROR_OF_MEAN|27.5524|||TWO_SIDED|95.0|-79.9|29.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||29.5|-79.9|
71655549|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-17.19|STANDARD_ERROR_OF_MEAN|27.0135|||TWO_SIDED|95.0|-70.9|36.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||36.5|-70.9|
71655550|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.62|STANDARD_ERROR_OF_MEAN|29.3023|||TWO_SIDED|95.0|-97.7|18.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||18.5|-97.7|
71711399|NCT00663260|142940038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.4395|||TWO_SIDED|95.0|-3.03|-1.29||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05; secondary efficacy analyses were not tested since the primary endpoint was not significant.|ANCOVA|||||-1.29|-3.03|
71655551|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-37.06|STANDARD_ERROR_OF_MEAN|29.5797|||TWO_SIDED|95.0|-95.7|21.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||21.6|-95.7|
71655552|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-52.45|STANDARD_ERROR_OF_MEAN|24.8429|||TWO_SIDED|95.0|-101.8|-3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-3.1|-101.8|
71655553|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-59.87|STANDARD_ERROR_OF_MEAN|23.0541|||TWO_SIDED|95.0|-105.6|-14.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-14.1|-105.6|
71655554|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-39.96|STANDARD_ERROR_OF_MEAN|22.9336|||TWO_SIDED|95.0|-85.5|5.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||5.5|-85.5|
71655555|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-38.99|STANDARD_ERROR_OF_MEAN|23.4683|||TWO_SIDED|95.0|-85.6|7.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||7.6|-85.6|
71655556|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-63.69|STANDARD_ERROR_OF_MEAN|27.3484|||TWO_SIDED|95.0|-118.1|-9.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-9.3|-118.1|
71655557|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-61.36|STANDARD_ERROR_OF_MEAN|27.2866|||TWO_SIDED|95.0|-115.6|-7.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||-7.2|-115.6|
71655558|NCT02037165|142829274|SUPERIORITY_OR_OTHER||adjusted mean difference|-49.4|STANDARD_ERROR_OF_MEAN|26.7541|||TWO_SIDED|95.0|-102.6|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.||3.8|-102.6|
71655559|NCT00532935|142829275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline A1C value.||||-0.28|-0.66|<0.001
71655560|NCT00532935|142829276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.6|STANDARD_DEVIATION|29.1|<|0.001|TWO_SIDED|95.0|-32.7|-22.4|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-22.4|-32.7|<0.001
71655561|NCT00532935|142829277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.2|STANDARD_DEVIATION|59.7|<|0.001|TWO_SIDED|95.0|-32.1|-8.3|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline 2-hour PMG value.||||-8.3|-32.1|<0.001
71655562|NCT00532935|142829278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|STANDARD_DEVIATION|40.3|<|0.001|TWO_SIDED|95.0|-19.0|-4.9|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.||||-4.9|-19.0|<0.001
71766018|NCT01375075|143034028|SUPERIORITY_OR_OTHER||LS Mean Difference|92.61|STANDARD_ERROR_OF_MEAN|9.04|<|0.001|TWO_SIDED|90.0|77.65|107.57||The P-value is for percent change from baseline in HDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||107.57|77.65|<0.001
71655563|NCT00532935|142829279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.3|2.8||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|Regression, Logistic|logistic regression model included a term for treatment and a covariate for the baseline A1C value.|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|||2.8|1.3|<0.001
71655564|NCT01568866|142829288|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.533|||<|0.0001|TWO_SIDED|95.0|0.437|0.651|||Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|"The PFS interim analysis was to be performed using a group sequential monitoring plan.~The monitoring plan included an O'Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025."||0.651|0.437|< 0.0001
71655565|NCT01568866|142829289|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.791||||0.01|TWO_SIDED|95.0|0.648|0.964||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O'Brien-Fleming-type α spending function based on the actual number of events (α=0.0123).||0.964|0.648|0.0100
71655566|NCT01568866|142829290|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.032|||<|0.0001|TWO_SIDED|95.0|1.519|2.718||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.|The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|||2.718|1.519|< 0.0001
71655567|NCT01568866|142829292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.089|0.21||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Cochran-Mantel-Haenszel||The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.|||0.210|0.089|<0.0001
71655568|NCT01698775|142829296|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.33||||0.035|TWO_SIDED|95.0|-0.63|-0.02|||ANCOVA|||||-0.02|-0.63|0.035
71655569|NCT01698775|142829297|SUPERIORITY_OR_OTHER||Difference in percentages|-3.8|||||TWO_SIDED|95.0|-16.3|8.8|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||8.8|-16.3|
71655570|NCT01698775|142829298|SUPERIORITY_OR_OTHER||Difference in percentages|1.9|||||TWO_SIDED|95.0|-2.6|7.2|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||7.2|-2.6|
71655571|NCT01698775|142829299|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-12.2|10.3|||||Based on Miettinen \& Nurminen method stratified by renal status stratum.|||10.3|-12.2|
71655572|NCT01698775|142829300|SUPERIORITY_OR_OTHER||Difference in percentage|2.8|||||TWO_SIDED|95.0|-3.6|9.8||||||||9.8|-3.6|
71655573|NCT01698775|142829301|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.9||||0.54|TWO_SIDED|95.0|-16.5|8.7|||ANCOVA|||||8.7|-16.5|0.540
71655574|NCT01698775|142829304|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.72|TWO_SIDED|95.0|-2.7|1.9|||cLDA|||||1.9|-2.7|0.720
71655575|NCT01244061|142829308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.08|||<|0.0001|TWO_SIDED|95.0|4.34|11.55||The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value \> 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.||11.55|4.34|<0.0001
71655576|NCT01244061|142829309|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|3.97|20.41||Statistical significance was declared for each hypothesis in the order above until a p-value \>0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.||20.41|3.97|<0.0001
71655577|NCT01244061|142829310|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.83|||<|0.0001|TWO_SIDED|95.0|3.25|10.44||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||||10.44|3.25|<0.0001
71655578|NCT01244061|142829311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.85|||<|0.0001|TWO_SIDED|95.0|4.92|12.51||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 12 assessment||12.51|4.92|<0.0001
71766019|NCT01375075|143034028|SUPERIORITY_OR_OTHER||LS Mean Difference|106.17|STANDARD_ERROR_OF_MEAN|10.69|<|0.001|TWO_SIDED|90.0|88.47|123.87||The P-value is for percent change from baseline in HDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||123.87|88.47|<0.001
71826847|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.082|STANDARD_ERROR_OF_MEAN|0.092||0.3692|TWO_SIDED|95.0|-0.098|0.262|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.262|-0.098|0.3692
71711400|NCT02231580|142940049|SUPERIORITY_OR_OTHER||GLS mean ratio|1.104|||=|0.5743|TWO_SIDED|90.0|0.823|1.482|||MMRM|||Left hand position-index statistical analysis is presented (BN82451B versus Placebo). The Mixed Effect Model Repeat Measurement (MMRM) analysis was performed on log-transformed data using the restricted maximum likelihood (REML) model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.482|0.823|=0.5743
71711401|NCT02231580|142940049|SUPERIORITY_OR_OTHER||GLS mean ratio|1.141|||=|0.4349|TWO_SIDED|90.0|0.862|1.51|||MMRM|||Right hand position-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.510|0.862|=0.4349
71711402|NCT02231580|142940050|SUPERIORITY_OR_OTHER||GLS mean ratio|1.035|||=|0.8937|TWO_SIDED|90.0|0.675|1.587|||MMRM|||Left hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.587|0.675|=0.8937
71711403|NCT02231580|142940050|SUPERIORITY_OR_OTHER||GLS mean ratio|1.093|||=|0.636|TWO_SIDED|90.0|0.8|1.493|||MMRM|||Right hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.493|0.800|=0.6360
71711404|NCT02231580|142940051|SUPERIORITY_OR_OTHER||GLS mean ratio|1.247|||=|0.2865|TWO_SIDED|90.0|0.886|1.756|||MMRM|||Left hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.756|0.886|=0.2865
71711405|NCT02231580|142940051|SUPERIORITY_OR_OTHER||GLS mean ratio|1.16|||=|0.5338|TWO_SIDED|90.0|0.781|1.724|||MMRM|||Right hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.724|0.781|=0.5338
71711406|NCT02231580|142940052|SUPERIORITY_OR_OTHER||GLS mean ratio|0.693|||=|0.0864|TWO_SIDED|90.0|0.487|0.985|||MMRM|||Left hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.985|0.487|=0.0864
71711407|NCT02231580|142940052|SUPERIORITY_OR_OTHER||GLS mean ratio|0.686|||=|0.0399|TWO_SIDED|90.0|0.508|0.925|||MMRM|||Right hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.925|0.508|=0.0399
71711408|NCT02231580|142940053|SUPERIORITY_OR_OTHER||GLS mean ratio|1.509|||=|0.0574|TWO_SIDED|90.0|1.06|2.15|||MMRM|||Left finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.150|1.060|=0.0574
71711409|NCT02231580|142940053|SUPERIORITY_OR_OTHER||GLS mean ratio|0.953|||=|0.8277|TWO_SIDED|90.0|0.662|1.372|||MMRM|||Right finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.372|0.662|=0.8277
71766020|NCT01375075|143034028|SUPERIORITY_OR_OTHER||LS Mean Difference|103.66|STANDARD_ERROR_OF_MEAN|11.18|<|0.001|TWO_SIDED|90.0|85.14|122.17||The P-value is for percent change from baseline in HDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||122.17|85.14|<0.001
71766021|NCT01375075|143034028|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.46|STANDARD_ERROR_OF_MEAN|4.39|<|0.001|TWO_SIDED|90.0|-24.73|-10.19||The P-value is for percent change from baseline in LDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-10.19|-24.73|<0.001
71826848|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.065|STANDARD_ERROR_OF_MEAN|0.09||0.4677|TWO_SIDED|95.0|-0.111|0.241|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.241|-0.111|0.4677
71711410|NCT02231580|142940053|SUPERIORITY_OR_OTHER||GLS mean ratio|1.238|||=|0.0162|TWO_SIDED|90.0|1.074|1.426|||MMRM|||Left finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.426|1.074|=0.0162
71711411|NCT02231580|142940053|SUPERIORITY_OR_OTHER||GLS mean ratio|1.038|||=|0.632|TWO_SIDED|90.0|0.912|1.182|||MMRM|||Right finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.182|0.912|=0.6320
71711412|NCT02231580|142940054|SUPERIORITY_OR_OTHER||GLS mean ratio|1.308|||=|0.3005|TWO_SIDED|90.0|0.85|2.014|||MMRM|||Left finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.014|0.85|=0.3005
71711413|NCT02231580|142940054|SUPERIORITY_OR_OTHER||GLS mean ratio|1.177|||=|0.4793|TWO_SIDED|90.0|0.804|1.722|||MMRM|||Right finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.722|0.804|=0.4793
71711414|NCT02231580|142940054|SUPERIORITY_OR_OTHER||GLS mean ratio|1.15|||=|0.2653|TWO_SIDED|90.0|0.934|1.416|||MMRM|||Left finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.416|0.934|=0.2653
71711415|NCT02231580|142940054|SUPERIORITY_OR_OTHER||GLS mean ratio|1.045|||=|0.6777|TWO_SIDED|90.0|0.875|1.248|||MMRM|||Right finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.248|0.875|=0.6777
71711416|NCT02231580|142940055|SUPERIORITY_OR_OTHER||GLS mean ratio|1.618|||=|0.0326|TWO_SIDED|90.0|1.124|2.331|||MMRM|||Left finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.331|1.124|=0.0326
71711417|NCT02231580|142940055|SUPERIORITY_OR_OTHER||GLS mean ratio|0.886|||=|0.6016|TWO_SIDED|90.0|0.605|1.299|||MMRM|||Right finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.299|0.605|=0.6016
71711418|NCT02231580|142940055|SUPERIORITY_OR_OTHER||GLS mean ratio|1.242|||=|0.0152|TWO_SIDED|90.0|1.077|1.433|||MMRM|||Left finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.433|1.077|=0.0152
71711419|NCT02231580|142940055|SUPERIORITY_OR_OTHER||GLS mean ratio|1.042|||=|0.6033|TWO_SIDED|90.0|0.915|1.186|||MMRM|||Right finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.186|0.915|=0.6033
71711420|NCT02231580|142940056|SUPERIORITY_OR_OTHER||GLS mean ratio|1.657|||=|0.052|TWO_SIDED|90.0|1.086|2.529|||MMRM|||Left finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.529|1.086|=0.0520
71711421|NCT02231580|142940056|SUPERIORITY_OR_OTHER||GLS mean ratio|0.916|||=|0.6978|TWO_SIDED|90.0|0.63|1.333|||MMRM|||Right finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.333|0.630|=0.6978
71711422|NCT02231580|142940056|SUPERIORITY_OR_OTHER||GLS mean ratio|1.298|||=|0.0522|TWO_SIDED|90.0|1.043|1.614|||MMRM|||Left finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.614|1.043|=0.0522
71766022|NCT01375075|143034028|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.39|STANDARD_ERROR_OF_MEAN|4.4||0.019|TWO_SIDED|90.0|-17.67|-3.11||The P-value is for percent change from baseline in LDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-3.11|-17.67|0.019
71711423|NCT02231580|142940056|SUPERIORITY_OR_OTHER||GLS mean ratio|1.014|||=|0.9012|TWO_SIDED|90.0|0.837|1.229|||MMRM|||Right finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.837|=0.9012
71711424|NCT02231580|142940057|SUPERIORITY_OR_OTHER||GLS mean ratio|1.198|||=|0.1779|TWO_SIDED|90.0|0.96|1.494|||MMRM|||Left finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.494|0.96|=0.1779
71711425|NCT02231580|142940057|SUPERIORITY_OR_OTHER||GLS mean ratio|0.966|||=|0.8036|TWO_SIDED|90.0|0.765|1.22|||MMRM|||Right finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.220|0.765|=0.8036
71711426|NCT02231580|142940058|SUPERIORITY_OR_OTHER||GLS mean ratio|0.812|||=|0.0177|TWO_SIDED|90.0|0.706|0.935|||MMRM|||Left finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.935|0.706|=0.0177
71711427|NCT02231580|142940058|SUPERIORITY_OR_OTHER||GLS mean ratio|0.967|||=|0.6491|TWO_SIDED|90.0|0.856|1.093|||MMRM|||Right finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.093|0.856|=0.6491
71711428|NCT02231580|142940059|SUPERIORITY_OR_OTHER||GLS mean ratio|1.168|||=|0.6176|TWO_SIDED|90.0|0.697|1.955|||MMRM|||Left hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.955|0.697|=0.6176
71711429|NCT02231580|142940059|SUPERIORITY_OR_OTHER||GLS mean ratio|0.759|||=|0.4541|TWO_SIDED|90.0|0.411|1.399|||MMRM|||Right hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.399|0.411|=0.4541
71711430|NCT02231580|142940059|SUPERIORITY_OR_OTHER||GLS mean ratio|1.119|||=|0.2018|TWO_SIDED|90.0|0.967|1.294|||MMRM|||Left hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.294|0.967|=0.2018
71711431|NCT02231580|142940059|SUPERIORITY_OR_OTHER||GLS mean ratio|1.046|||=|0.6527|TWO_SIDED|90.0|0.886|1.234|||MMRM|||Right hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.234|0.886|=0.6527
71711432|NCT02231580|142940060|SUPERIORITY_OR_OTHER||GLS mean ratio|0.929|||=|0.8279|TWO_SIDED|90.0|0.529|1.63|||MMRM|||Left hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.630|0.529|=0.8279
71766023|NCT01375075|143034028|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.26|STANDARD_ERROR_OF_MEAN|4.77||0.011|TWO_SIDED|90.0|-20.17|-4.36||The P-value is for percent change from baseline in LDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-4.36|-20.17|0.011
71826849|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.1|STANDARD_ERROR_OF_MEAN|0.106||0.3427|TWO_SIDED|95.0|-0.107|0.307|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.307|-0.107|0.3427
71711433|NCT02231580|142940060|SUPERIORITY_OR_OTHER||GLS mean ratio|0.612|||=|0.2738|TWO_SIDED|90.0|0.292|1.283|||MMRM|||Right hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.283|0.292|=0.2738
71711434|NCT02231580|142940060|SUPERIORITY_OR_OTHER||GLS mean ratio|1.018|||=|0.9218|TWO_SIDED|90.0|0.752|1.378|||MMRM|||Left hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.378|0.752|=0.9218
71711435|NCT02231580|142940060|SUPERIORITY_OR_OTHER||GLS mean ratio|0.847|||=|0.5032|TWO_SIDED|90.0|0.561|1.277|||MMRM|||Right hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.277|0.561|=0.5032
71711436|NCT02231580|142940061|SUPERIORITY_OR_OTHER||GLS mean ratio|1.14|||=|0.6759|TWO_SIDED|90.0|0.677|1.917|||MMRM|||Left hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.917|0.677|=0.6759
71826850|NCT00383188|143158065|SUPERIORITY||LSM Difference|0.135|STANDARD_ERROR_OF_MEAN|0.108||0.212|TWO_SIDED|95.0|-0.077|0.347|||ANCOVA|||Week 16: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 16 as an interaction term, baseline HAQ-DI as the covariate and participant as a random effect.||0.347|-0.077|0.2120
71766024|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|2.5||0.136|TWO_SIDED|90.0|-0.39|7.88||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||7.88|-0.39|0.136
71766025|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|2.48||0.257|TWO_SIDED|90.0|-1.28|6.94||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||6.94|-1.28|0.257
71766026|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.54||0.021|TWO_SIDED|90.0|1.7|10.1||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||10.10|1.70|0.021
71766027|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|2.52||0.829|TWO_SIDED|90.0|-4.71|3.62||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.62|-4.71|0.829
71766028|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.5||0.603|TWO_SIDED|90.0|-1.69|3.24||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.24|-1.69|0.603
71655579|NCT01244061|142829311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.86|4.64||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 24 assessment||4.64|1.86|<0.0001
71655580|NCT01244061|142829311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.88|4.97||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 52 assessment||4.97|1.88|<0.0001
71655581|NCT00586482|142829325|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||A two-sided p value of less than or equal to 0.05 was considered statistically significant.||||0.12
71655582|NCT00586482|142829326|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
71655583|NCT00586482|142829327|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
71655584|NCT00586482|142829328|SUPERIORITY_OR_OTHER|||||||0.93|||||||t-test, 2 sided|||||||0.93
71655585|NCT00586482|142829329|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71655586|NCT03623386|142829363|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
71655587|NCT03623386|142829364|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
71655588|NCT03623386|142829365|SUPERIORITY||||||>|0.05|||||||ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||>0.05
71655589|NCT03623386|142829366|SUPERIORITY|||||||0.026||||||p value reflects the effect of time.|ANOVA|||Testing for main effects (group), time effect and the interaction of group and time.||||0.026
71655590|NCT04271735|142829389|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71655591|NCT00515541|142829392|SUPERIORITY_OR_OTHER|||||||0.01||||||A P-value \<0.05 when compared to baseline is considered significant.|Wilcoxon (Mann-Whitney)|||Group B baseline vs. Group B Week 12||||0.01
71655592|NCT00515541|142829393|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 6.||||<0.001
71655593|NCT00515541|142829393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 12.||||<0.001
71655594|NCT00922272|142829398|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71655595|NCT00922272|142829400|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.4182|TWO_SIDED|95.0|-3.4|8.1|||ANCOVA|||||8.1|-3.4|0.4182
71655596|NCT00922272|142829401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||Fisher Exact|||||||0.6705
71655597|NCT00922272|142829402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Affective Flattening||||<0.0001
71655598|NCT00922272|142829402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Alogia||||<0.0001
71655599|NCT00922272|142829402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Avolition-Apathy||||<0.0001
71655600|NCT00922272|142829402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Anhedonia-Asociality||||<0.0001
71655601|NCT00922272|142829402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Attention||||<0.0001
71655602|NCT00922272|142829403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.8771|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Affective Flattening||0.5|-0.4|0.8771
71655603|NCT00922272|142829403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0584|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Alogia||1.1|0.0|0.0584
71655604|NCT00922272|142829403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5215|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Avolition-Apathy||0.6|-0.3|0.5215
71655605|NCT00922272|142829403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.4835|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Anhedonia-Asociality||0.7|-0.3|0.4835
71655606|NCT00922272|142829403|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.5723|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Attention||0.7|-0.4|0.5723
71655607|NCT00922272|142829404|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Positive subscale||||<0.0001
71711437|NCT02231580|142940061|SUPERIORITY_OR_OTHER||GLS mean ratio|0.815|||=|0.5764|TWO_SIDED|90.0|0.444|1.496|||MMRM|||Right hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.496|0.444|=0.5764
71655608|NCT00922272|142829404|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Negative subscale||||<0.0001
71655609|NCT00922272|142829404|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||General Psychopathology subscale||||<0.0001
71655610|NCT00922272|142829405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.1975|TWO_SIDED|95.0|-0.3|1.5|||ANCOVA|||Positive subscale||1.5|-0.3|0.1975
71655611|NCT00922272|142829405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.1228|TWO_SIDED|95.0|-0.3|2.3|||ANCOVA|||Negative subscale||2.3|-0.3|0.1228
71655612|NCT00922272|142829405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.1115|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||General Psychopathology subscale||3.9|-0.4|0.1115
71655613|NCT00922272|142829412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0307||95.0|||||t-test, 2 sided|||||||0.0307
71655614|NCT00922272|142829413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1072|TWO_SIDED|95.0|-0.6|6.2|||ANCOVA|||||6.2|-0.6|0.1072
71655615|NCT00922272|142829414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.366||95.0|||||t-test, 2 sided|||||||0.3660
71655616|NCT00922272|142829415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4347|TWO_SIDED|95.0|-5.0|2.2|||ANCOVA|||||2.2|-5.0|0.4347
71655617|NCT00922272|142829416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4312||95.0|||||t-test, 2 sided|||||||0.4312
71655618|NCT00922272|142829417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||0.0874|TWO_SIDED|95.0|-5.4|0.4|||ANCOVA|||||0.4|-5.4|0.0874
71655619|NCT00922272|142829418|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||Total Skills||||<0.0001
71655620|NCT00922272|142829418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||t-test, 2 sided|||Communication Skills||||0.0002
71655621|NCT00922272|142829418|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0|||||t-test, 2 sided|||Financial Skills||||0.0028
71655622|NCT00922272|142829419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4637|TWO_SIDED|95.0|-5.3|2.4|||ANCOVA|||Total Skills||2.4|-5.3|0.4637
71655623|NCT00922272|142829419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.6137|TWO_SIDED|95.0|-4.1|2.4|||ANCOVA|||Communication Skills||2.4|-4.1|0.6137
71655624|NCT00922272|142829419|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.3482|TWO_SIDED|95.0|-3.5|1.3|||ANCOVA|||Financial Skills||1.3|-3.5|0.3482
71655625|NCT00922272|142829420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0174||95.0|||||t-test, 2 sided|||Global Executive Composite||||0.0174
71655626|NCT00922272|142829420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0461||95.0|||||t-test, 2 sided|||Behavioral Recognition Index||||0.0461
71655627|NCT00922272|142829420|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||t-test, 2 sided|||Metacognition Index||||0.0146
71655628|NCT00922272|142829421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.7418|TWO_SIDED|95.0|-3.8|2.7|||ANCOVA|||Global Executive Composite||2.7|-3.8|0.7418
71655629|NCT00922272|142829421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.6429|TWO_SIDED|95.0|-2.6|4.1|||ANCOVA|||Behavioral Recognition Index||4.1|-2.6|0.6429
71655630|NCT00922272|142829421|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.4364|TWO_SIDED|95.0|-4.8|2.1|||ANCOVA|||Metacognition Index||2.1|-4.8|0.4364
71655631|NCT02588950|142829432|SUPERIORITY||Geometric LSMean Ratio|1.46|||||TWO_SIDED|90.0|1.08|1.97|||Mixed Models Analysis|||||1.97|1.08|
71655632|NCT02588950|142829436|SUPERIORITY||Geometric LSMean Ratio|0.885|||||TWO_SIDED|90.0|0.761|1.03|||Mixed Models Analysis|||||1.03|0.761|
71655633|NCT02588950|142829437|SUPERIORITY||Median Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-1.6|2.6||||||||2.60|-1.60|
71655634|NCT01936519|142829452|EQUIVALENCE|Mann Whitney U Test was performed|Mean Difference (Net)|27.32|STANDARD_ERROR_OF_MEAN|20.61||0.283|TWO_SIDED|95.0|-16.17|70.8||Cockcroft-Gault Clearance|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Cockcroft Gault Creatinine clearance 2 year data.||70.80|-16.17|0.283
71655635|NCT01936519|142829453|EQUIVALENCE|Wilcoxon Test|Median Difference (Final Values)|34.08|STANDARD_ERROR_OF_MEAN|11.44||0.013|TWO_SIDED|95.0|9.95|58.21|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the MDRD Clearance 2 year data row data.||58.21|9.95|0.013
71655636|NCT01936519|142829454|EQUIVALENCE|Wilcoxon Test|Mean Difference (Final Values)|22.22|STANDARD_ERROR_OF_MEAN|12.09||0.099|TWO_SIDED|95.0|-3.28|47.72|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on the Iothalamate Clearance 2 year data.||47.72|-3.28|0.099
71655637|NCT01936519|142829454|EQUIVALENCE|Non-parametric statistical tests were used for all analyses, including the Mann-Whitney U test for continuous outcomes and Pearson's chi-square test for binary outcomes. Univariate statistical tests were used for all comparisons. Cohen's d was utilized for all comparisons to provide information about effect size.|Mean Difference (Final Values)|29.08|STANDARD_ERROR_OF_MEAN|13.29||0.032|TWO_SIDED|95.0|1.04|57.1|||Wilcoxon (Mann-Whitney)|||"Power and sample size. The assumption was made that eGFR would improve from 34 mL/min/1.73 m2 to 43 mL/min/1.73 m2. It was determined that a sample size of 12 in each group would have 80% power to detect a difference in means of -9.0 (the difference between a group 1 mean of 34.0 and a group 2 mean of 43.0) assuming that the common standard deviation was 7.5 using a two group t-test with a 0.05 two-sided significance level.~Data from the 2 year time point was used for analysis."||57.1|1.04|.032
71655638|NCT01936519|142829454|EQUIVALENCE|Difference of zero hypothesized.|Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.263||0.015|TWO_SIDED|95.0|-1.11|-0.003|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed on 2 year data time point.||-0.003|-1.11|0.015
71655639|NCT02072824|142829456|SUPERIORITY||Least Square Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4606|TWO_SIDED|95.0|-0.19|0.42|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||0.42|-0.19|0.4606
71826851|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.587|STANDARD_ERROR_OF_MEAN|0.337||0.0815|TWO_SIDED|95.0|-1.248|0.074|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.074|-1.248|0.0815
71826852|NCT00383188|143158066|SUPERIORITY||LSM Difference|-1.057|STANDARD_ERROR_OF_MEAN|0.331||0.0015|TWO_SIDED|95.0|-1.707|-0.407|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.407|-1.707|0.0015
71655640|NCT02072824|142829456|SUPERIORITY||Least Square Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.185||0.0223|TWO_SIDED|95.0|-0.8|-0.06|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.||-0.06|-0.80|0.0223
71655641|NCT02072824|142829457|SUPERIORITY||Odds Ratio (OR)|0.625||||0.2418|TWO_SIDED|95.0|0.284|1.373|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||1.373|0.284|0.2418
71655642|NCT02072824|142829457|SUPERIORITY||Odds Ratio (OR)|1.622||||0.305|TWO_SIDED|95.0|0.644|4.086|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.||4.086|0.644|0.3050
71655643|NCT00841906|142829478|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71655644|NCT00903448|142829482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0||||The least squares treatment means, i.e. adjusted treatment means, and standard errors were computed from the analysis of variance models.|Mixed Models Analysis|||This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH \> 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.||||< 0.0001
71655645|NCT00912093|142829485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71655646|NCT00912093|142829486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71655647|NCT00912093|142829487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Peto Peto Wilcoxon|||||||0.012
71655648|NCT00912093|142829488|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71655649|NCT00912093|142829489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Peto-Peto Wilcoxon|||||||<0.001
71655650|NCT04397445|142829506|SUPERIORITY|||||||0.54||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is 0 (-6.9 to 0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.54
71655651|NCT04397445|142829506|SUPERIORITY|||||||0.71||||||A 1-sided lower P value \<.05 was considered significant for ranitidine vs. placebo as the aim was to evaluate if ranitidine increased NDMA exposure. Comparisons were performed separately with each diet without adjustment for multiplicity.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between ranitidine and placebo is -1.1 (-9.1 to 11.5) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.71
71655652|NCT04397445|142829507|SUPERIORITY|||||||0.005||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA.|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 9.3 (3.8 to 25.0) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.005
71655653|NCT04397445|142829507|SUPERIORITY|||||||0.007||||||Exploratory analyses on the effect of diet used a 1-sided lower P value \<.05 for NDMA as the cured-meats diet was designed to have higher NDMA|Wilcoxon (Mann-Whitney)|||A Wilcoxon signed-rank test was used for analyses, per the statistical analysis plan, as NDMA urine data were not normally distributed|The median of the paired differences (interquartile range) between the cured-meats diet and noncured-meats diet is 6.4 (0 to 23.4) ng. The median of the paired differences is calculated by first determining the difference between the two treatments for each individual participant and then determining the median of those values. The Wilcoxon signed-rank test that was used for NDMA analyses is also based on first determining the difference between the treatment groups for each individual participant.|||0.007
71655654|NCT04397445|142829508|OTHER||Geometric Mean Ratio|0.94||||0.92|TWO_SIDED|90.0|0.87|1.01||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.01|0.87|0.92
71766029|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|1.48||0.656|TWO_SIDED|90.0|-3.11|1.78||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.78|-3.11|0.656
71766030|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|1.52||0.228|TWO_SIDED|90.0|-0.67|4.34||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.34|-0.67|0.228
71766031|NCT01375075|143034031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.51||0.516|TWO_SIDED|90.0|-3.47|1.51||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.51|-3.47|0.516
71766032|NCT01375075|143034032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.11||0.513|TWO_SIDED|90.0|-2.57|1.11|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.11|-2.57|0.513
71766033|NCT01375075|143034032|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.12||0.97|TWO_SIDED|90.0|-1.82|1.9|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.90|-1.82|0.970
71766034|NCT01375075|143034032|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.16||0.824|TWO_SIDED|90.0|-1.66|2.17|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.17|-1.66|0.824
71766035|NCT01375075|143034032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.12||0.769|TWO_SIDED|90.0|-2.18|1.52|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.52|-2.18|0.769
71655655|NCT04397445|142829508|OTHER||Geometric Mean Ratio|0.95||||0.74|TWO_SIDED|90.0|0.81|1.1||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator).|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.10|0.81|0.74
71655656|NCT04397445|142829508|OTHER||Geometric Mean Ratio|1.05||||0.52|TWO_SIDED|95.0|0.9|1.23||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.23|0.90|0.52
71655657|NCT04397445|142829508|OTHER||Geometric Mean Ratio|1.05||||0.42|TWO_SIDED|95.0|0.93|1.19||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||1.19|0.93|0.42
71655658|NCT04397445|142829509|OTHER||Geometric Mean Ratio|0.81||||0.001|TWO_SIDED|95.0|0.72|0.91||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.91|0.72|0.001
71655659|NCT04397445|142829511|OTHER||Geometric Mean Ratio|1.0||||0.46|TWO_SIDED|90.0|0.91|1.11||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis||This compares the results from ranitidine (numerator) with placebo (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||1.11|0.91|0.46
71655660|NCT04397445|142829511|OTHER||Geometric Mean Ratio|1.0||||0.49|TWO_SIDED|90.0|0.8|1.25||A 1-sided lower P value \<.05 was considered significant for the exploratory analyses of ranitidine vs. placebo because the study aim was to evaluate if ranitidine increased DMA exposure.|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from ranitidine (numerator) with placebo (denominator)|1.25|0.80|0.49
71655661|NCT04397445|142829511|OTHER||Geometric Mean Ratio|0.8||||0.02|TWO_SIDED|95.0|0.67|0.95||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence.||0.95|0.67|0.02
71655662|NCT04397445|142829511|OTHER||Geometric Mean Ratio|0.8||||0.03|TWO_SIDED|95.0|0.65|0.98||A 2-sided P value \<.05 was used for DMA as the diet was not expected to affect these outcomes|Mixed Models Analysis|||As DMA data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence|This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator)|0.98|0.65|0.03
71655663|NCT04397445|142829512|OTHER||Geometric Mean Ratio|0.77||||0.002|TWO_SIDED|95.0|0.66|0.89||Exploratory analyses on the effect of diet used a 2-sided P value \<.05 for ranitidine as the diet was not expected to affect these outcomes|Mixed Models Analysis||This compares the results from the cured-meats diet (numerator) with the noncured-meats diet (denominator).|As ranitidine data were log-normally distributed, analyses were based on a mixed-effect analysis of geometric means with terms for treatment, period, and sequence||0.89|0.66|0.002
71655664|NCT00270257|142829530|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|1.5|||||TWO_SIDED|95.0|0.7|2.8||||||||2.8|0.7|
71655665|NCT00270257|142829530|SUPERIORITY_OR_OTHER_LEGACY||Incident rate per 100 person-years|2.2|||||TWO_SIDED|95.0|1.2|3.7||||||||3.7|1.2|
71766036|NCT01375075|143034033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.33||0.735|TWO_SIDED|90.0|-0.65|0.43|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.43|-0.65|0.735
71766037|NCT01375075|143034033|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.33||0.503|TWO_SIDED|90.0|-0.32|0.76|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.76|-0.32|0.503
71766038|NCT01375075|143034033|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.988|TWO_SIDED|90.0|-0.53|0.54|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.54|-0.53|0.988
71766039|NCT01375075|143034033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.32||0.207|TWO_SIDED|90.0|-0.95|0.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.13|-0.95|0.207
71766040|NCT01375075|143034034|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.43||0.756|TWO_SIDED|90.0|-0.57|0.84|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.84|-0.57|0.756
71766041|NCT01375075|143034034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.43||0.99|TWO_SIDED|90.0|-0.71|0.7|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.70|-0.71|0.990
71766042|NCT01375075|143034034|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.565|TWO_SIDED|90.0|-0.47|0.97|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.97|-0.47|0.565
71766043|NCT01375075|143034034|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.43||0.678|TWO_SIDED|90.0|-0.53|0.89|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||0.89|-0.53|0.678
71766044|NCT01375075|143034035|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.61||0.856|TWO_SIDED|90.0|-0.9|1.12|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.12|-0.90|0.856
71766045|NCT01375075|143034035|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.869|TWO_SIDED|90.0|-0.9|1.1|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.10|-0.90|0.869
71655666|NCT00270257|142829530|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.694||||0.3769|TWO_SIDED|95.0|0.308|1.562|||Regression, Cox|||||1.562|0.308|0.3769
71655667|NCT00270257|142829531|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.844||||0.4325|TWO_SIDED|95.0|0.553|1.289||P value applies for the comparison at visit 104.|Regression, Logistic|adjusted for site||||1.289|0.553|0.4325
71655668|NCT00270257|142829532|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.2749|TWO_SIDED|95.0|0.536|1.194||P value applies for the comparison at visit 104 only.|Regression, Logistic|||||1.194|0.536|0.2749
71655669|NCT00270257|142829533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.746||||0.3446|TWO_SIDED|95.0|0.407|1.369||Analysis is done for visit 104|Regression, Logistic|Adjusted for site||||1.369|0.407|0.3446
71655670|NCT00270257|142829534|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8712||||0.362|TWO_SIDED|95.0|0.6477|1.1718||P value applies for the comparison at visit 104 only. See the estimation comments for the other visits|Generalized linear model|adjusted for site.||||1.1718|0.6477|0.3620
71655671|NCT00270257|142829535|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|22.0|||||TWO_SIDED|95.0|14.7|31.6|||||29 events over 132 person-years|||31.6|14.7|
71655672|NCT00270257|142829535|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|4.59|||||TWO_SIDED|95.0|2.0|9.0|||||8 events over 174 person-years|||9.0|2.0|
71655673|NCT00270257|142829536|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|2.7|||||TWO_SIDED|95.0|1.22|5.08|||||9 events over 336 person-years|||5.08|1.22|
71655674|NCT00270257|142829536|SUPERIORITY_OR_OTHER_LEGACY||Incident rate of 100 person-years|0.0|||||TWO_SIDED|95.0|0.0|10.1|||||0 events over 37 person-years|||10.1|0.00|
71655675|NCT01338649|142829545|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0211|||||||t-test, 2 sided|t-test on two groups of differences||||||0.0211
71655676|NCT00361335|142829562|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VI at α = 0.05.||||0.051
71655677|NCT00361335|142829562|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31% response in the Group I at α = 0.05.||||0.073
71655678|NCT00361335|142829562|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group III at α = 0.05.||||0.093
71655679|NCT00361335|142829562|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group VII at α = 0.05.||||0.465
71711438|NCT02231580|142940061|SUPERIORITY_OR_OTHER||GLS mean ratio|1.115|||=|0.2127|TWO_SIDED|90.0|0.965|1.289|||MMRM|||Left hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.289|0.965|=0.2127
71711439|NCT02231580|142940061|SUPERIORITY_OR_OTHER||GLS mean ratio|1.059|||=|0.5661|TWO_SIDED|90.0|0.897|1.25|||MMRM|||Right hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.25|0.897|=0.5661
71711440|NCT02231580|142940062|SUPERIORITY_OR_OTHER||GLS mean ratio|1.571|||=|0.0874|TWO_SIDED|90.0|1.018|2.424|||MMRM|||Left hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.424|1.018|=0.0874
71711441|NCT02231580|142940062|SUPERIORITY_OR_OTHER||GLS mean ratio|1.18|||=|0.6431|TWO_SIDED|90.0|0.644|2.162|||MMRM|||Right hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.162|0.644|=0.6431
71711442|NCT02231580|142940062|SUPERIORITY_OR_OTHER||GLS mean ratio|1.193|||=|0.0389|TWO_SIDED|90.0|1.038|1.371|||MMRM|||Left hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.371|1.038|=0.0389
71711443|NCT02231580|142940062|SUPERIORITY_OR_OTHER||GLS mean ratio|1.138|||=|0.1641|TWO_SIDED|90.0|0.976|1.327|||MMRM|||Right hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.327|0.976|=0.1641
71711444|NCT02231580|142940063|SUPERIORITY_OR_OTHER||GLS mean ratio|0.93|||=|0.5668|TWO_SIDED|90.0|0.755|1.147|||MMRM|||Left hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.147|0.755|=0.5668
71766046|NCT01375075|143034035|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.869|TWO_SIDED|90.0|-0.92|1.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.13|-0.92|0.869
71766047|NCT01375075|143034035|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.61||0.317|TWO_SIDED|90.0|-0.4|1.63|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||1.63|-0.40|0.317
71766048|NCT01375075|143034037|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.888|TWO_SIDED|90.0|-0.24|0.2|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.20|-0.24|0.888
71766049|NCT01375075|143034037|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.939|TWO_SIDED|90.0|-0.21|0.23|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.23|-0.21|0.939
71766050|NCT01375075|143034037|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.296|TWO_SIDED|90.0|-0.08|0.36|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.36|-0.08|0.296
71766051|NCT01375075|143034037|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.181|TWO_SIDED|90.0|-0.04|0.4|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.||||0.40|-0.04|0.181
71711445|NCT02231580|142940063|SUPERIORITY_OR_OTHER||GLS mean ratio|0.978|||=|0.8686|TWO_SIDED|90.0|0.778|1.229|||MMRM|||Right hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.229|0.778|=0.8686
71711446|NCT02231580|142940064|SUPERIORITY_OR_OTHER||GLS mean ratio|0.879|||=|0.1244|TWO_SIDED|90.0|0.765|1.009|||MMRM|||Left hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.009|0.765|=0.1244
71711447|NCT02231580|142940064|SUPERIORITY_OR_OTHER||GLS mean ratio|0.919|||=|0.3535|TWO_SIDED|90.0|0.789|1.069|||MMRM|||Right hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.069|0.789|=0.3535
71711448|NCT02231580|142940065|SUPERIORITY_OR_OTHER||GLS mean ratio|2.163|||=|0.015|TWO_SIDED|90.0|1.295|3.614|||MMRM|||Left foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.614|1.295|=0.015
71766052|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.29|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|90.0|-53.16|-33.41||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-33.41|-53.16|<0.001
71655680|NCT00361335|142829562|SUPERIORITY_OR_OTHER|||||||0.872||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the Group II at α = 0.05.||||0.872
71655681|NCT00361335|142829562|SUPERIORITY_OR_OTHER|||||||0.175||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and \~29-31 percentage response in the combined group (I and III) at α = 0.05.||||0.175
71655682|NCT00361335|142829563|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.||||0.002
71655683|NCT00361335|142829563|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.||||0.032
71655684|NCT00361335|142829563|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.||||<0.001
71655685|NCT00361335|142829563|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.||||0.795
71655686|NCT00361335|142829563|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.||||0.844
71655687|NCT00361335|142829563|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.540
71655688|NCT00361335|142829564|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
71655689|NCT00361335|142829564|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
71655690|NCT00361335|142829564|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
71655691|NCT00361335|142829564|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||0.002
71655692|NCT00361335|142829564|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.043
71655693|NCT00361335|142829564|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||<0.001
71655694|NCT00361335|142829565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||<0.001
71655695|NCT00361335|142829565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||<0.001
71655696|NCT00361335|142829565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||<0.001
71655697|NCT00361335|142829565|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.||||<0.001
71655698|NCT00361335|142829565|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.003
71655699|NCT00361335|142829565|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||2-sided Cochran-Mantel-Haenszel|No adjustments were made to control for multiplicity||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.001
71655700|NCT00361335|142829566|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.||||0.005
71655701|NCT00361335|142829566|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.||||0.014
71655702|NCT00361335|142829566|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.||||0.014
71655703|NCT00361335|142829566|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.||||0.996
71655704|NCT00361335|142829566|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.||||0.738
71711449|NCT02231580|142940065|SUPERIORITY_OR_OTHER||GLS mean ratio|1.274|||=|0.5136|TWO_SIDED|90.0|0.688|2.361|||MMRM|||Right foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.361|0.688|=0.5136
71711450|NCT02231580|142940065|SUPERIORITY_OR_OTHER||GLS mean ratio|1.56|||=|0.0218|TWO_SIDED|90.0|1.139|2.137|||MMRM|||Left foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.137|1.139|=0.0218
71711451|NCT02231580|142940065|SUPERIORITY_OR_OTHER||GLS mean ratio|1.251|||=|0.372|TWO_SIDED|90.0|0.825|1.899|||MMRM|||Right foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.899|0.825|=0.3720
71766053|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.93|STANDARD_ERROR_OF_MEAN|6.02|<|0.001|TWO_SIDED|90.0|-86.89|-66.97||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-66.97|-86.89|<0.001
71826853|NCT00383188|143158066|SUPERIORITY||LSM Difference|-1.107|STANDARD_ERROR_OF_MEAN|0.385||0.0042|TWO_SIDED|95.0|-1.863|-0.351|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.351|-1.863|0.0042
71766054|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-90.81|STANDARD_ERROR_OF_MEAN|6.08|<|0.001|TWO_SIDED|90.0|-100.87|-80.75||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-80.75|-100.87|<0.001
71766055|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.25|STANDARD_ERROR_OF_MEAN|5.96|<|0.001|TWO_SIDED|90.0|-77.12|-57.39||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-57.39|-77.12|<0.001
71766056|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|90.0|-52.88|-32.33||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-32.33|-52.88|<0.001
71766057|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.93|STANDARD_ERROR_OF_MEAN|6.17|<|0.001|TWO_SIDED|90.0|-89.15|-68.71||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-68.71|-89.15|<0.001
71766058|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.67|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|90.0|-104.08|-83.26||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-83.26|-104.08|<0.001
71766059|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.01|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|90.0|-85.46|-64.57||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-64.57|-85.46|<0.001
71826854|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.842|STANDARD_ERROR_OF_MEAN|0.398||0.0348|TWO_SIDED|95.0|-1.624|-0.06|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.060|-1.624|0.0348
71826855|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.442|STANDARD_ERROR_OF_MEAN|0.332||0.1843|TWO_SIDED|95.0|-1.095|0.211|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.095|0.1843
71766060|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.28|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-58.53|-42.04||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-42.04|-58.53|<0.001
71766061|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.07|STANDARD_ERROR_OF_MEAN|4.98|<|0.001|TWO_SIDED|90.0|-91.32|-74.83||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-74.83|-91.32|<0.001
71766062|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-94.51|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|90.0|-102.92|-86.1||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-86.10|-102.92|<0.001
71711452|NCT02231580|142940066|SUPERIORITY_OR_OTHER||GLS mean ratio|1.911|||=|0.915|TWO_SIDED|90.0|1.017|3.592|||MMRM|||Left foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.592|1.017|=0.915
71711453|NCT02231580|142940066|SUPERIORITY_OR_OTHER||GLS mean ratio|1.687|||=|0.2745|TWO_SIDED|90.0|0.762|3.737|||MMRM|||Right foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|0.762|=0.2745
71711454|NCT02231580|142940066|SUPERIORITY_OR_OTHER||GLS mean ratio|1.598|||=|0.1148|TWO_SIDED|90.0|0.98|2.608|||MMRM|||Left foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.608|0.980|=0.1148
71711455|NCT02231580|142940066|SUPERIORITY_OR_OTHER||GLS mean ratio|1.454|||=|0.308|TWO_SIDED|90.0|0.789|2.679|||MMRM|||Right foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.679|0.789|=0.3080
71711456|NCT02231580|142940067|SUPERIORITY_OR_OTHER||GLS mean ratio|2.272|||=|0.0079|TWO_SIDED|90.0|1.381|3.737|||MMRM|||Left foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.737|1.381|=0.0079
71711457|NCT02231580|142940067|SUPERIORITY_OR_OTHER||GLS mean ratio|1.21|||=|0.0204|TWO_SIDED|90.0|0.686|2.133|||MMRM|||Right foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.133|0.686|=0.0204
71711458|NCT02231580|142940067|SUPERIORITY_OR_OTHER||GLS mean ratio|1.564|||=|0.0204|TWO_SIDED|90.0|1.144|2.138|||MMRM|||Left foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.138|1.144|=0.0204
71711459|NCT02231580|142940067|SUPERIORITY_OR_OTHER||GLS mean ratio|1.269|||=|0.3144|TWO_SIDED|90.0|0.856|1.884|||MMRM|||Right foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.884|0.856|=0.3144
71826856|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.582|STANDARD_ERROR_OF_MEAN|0.327||0.076|TWO_SIDED|95.0|-1.225|0.061|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.061|-1.225|0.0760
71826857|NCT00383188|143158066|SUPERIORITY||LSM Difference|-1.019|STANDARD_ERROR_OF_MEAN|0.382||0.0078|TWO_SIDED|95.0|-1.769|-0.27|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.270|-1.769|0.0078
71826858|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.517|STANDARD_ERROR_OF_MEAN|0.395||0.1905|TWO_SIDED|95.0|-1.292|0.258|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.258|-1.292|0.1905
71826859|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.332||0.6552|TWO_SIDED|95.0|-0.801|0.504|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.504|-0.801|0.6552
71711460|NCT02231580|142940068|SUPERIORITY_OR_OTHER||GLS mean ratio|1.914|||=|0.0324|TWO_SIDED|90.0|1.167|3.141|||MMRM|||Left foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||3.141|1.167|=0.0324
71711461|NCT02231580|142940068|SUPERIORITY_OR_OTHER||GLS mean ratio|1.462|||=|0.246|TWO_SIDED|90.0|0.85|2.515|||MMRM|||Right foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||2.515|0.85|=0.246
71711462|NCT02231580|142940068|SUPERIORITY_OR_OTHER||GLS mean ratio|1.387|||=|0.1057|TWO_SIDED|90.0|0.994|1.935|||MMRM|||Left foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.935|0.994|=0.1057
71711463|NCT02231580|142940068|SUPERIORITY_OR_OTHER||GLS mean ratio|1.074|||=|0.7342|TWO_SIDED|90.0|0.758|1.523|||MMRM|||Right foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.523|0.758|=0.7342
71711464|NCT02231580|142940069|SUPERIORITY_OR_OTHER||GLS mean ratio|1.392|||=|0.1027|TWO_SIDED|90.0|0.997|1.943|||MMRM|||Left foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.943|0.997|=0.1027
71711465|NCT02231580|142940069|SUPERIORITY_OR_OTHER||GLS mean ratio|1.158|||=|0.4494|TWO_SIDED|90.0|0.84|1.595|||MMRM|||Right foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.595|0.840|=0.4494
71711466|NCT02231580|142940070|SUPERIORITY_OR_OTHER||GLS mean ratio|0.699|||=|0.035|TWO_SIDED|90.0|0.53|0.922|||MMRM|||Left foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||0.922|0.530|=0.0350
71766063|NCT01375075|143034038|SUPERIORITY_OR_OTHER||LS Mean Difference|-67.68|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|90.0|-76.2|-59.16||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-59.16|-76.20|<0.001
71766064|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.38|2.21||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.21|1.38|<0.001
71766065|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|2.65|3.48||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.48|2.65|<0.001
71826860|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.327||0.0281|TWO_SIDED|95.0|-1.363|-0.078|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.078|-1.363|0.0281
71826861|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.382||0.0263|TWO_SIDED|95.0|-1.599|-0.1|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.100|-1.599|0.0263
71826862|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.429|STANDARD_ERROR_OF_MEAN|0.395||0.2772|TWO_SIDED|95.0|-1.204|0.346|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.346|-1.204|0.2772
71826863|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.024|STANDARD_ERROR_OF_MEAN|0.332||0.9433|TWO_SIDED|95.0|-0.676|0.629|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.629|-0.676|0.9433
71766066|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|3.04|3.88||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.88|3.04|<0.001
71766067|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|1.81|2.63||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.81|<0.001
71826864|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.768|STANDARD_ERROR_OF_MEAN|0.327||0.193|TWO_SIDED|95.0|-1.41|-0.125|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.125|-1.410|0.193
71826865|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.763|STANDARD_ERROR_OF_MEAN|0.382||0.461|TWO_SIDED|95.0|-1.512|-0.013|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.013|-1.512|0.461
71711467|NCT02231580|142940070|SUPERIORITY_OR_OTHER||GLS mean ratio|0.853|||=|0.3556|TWO_SIDED|90.0|0.64|1.136|||MMRM|||Right foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.||1.136|0.640|=0.3556
71711468|NCT03620981|142940071|SUPERIORITY||LS Mean Difference (Final Values)|-7.2|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.3|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-4.3|-10.0|< 0.0001
71766068|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.4|2.36||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.36|1.40|<0.001
71655705|NCT00361335|142829566|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||No adjustments were made to control for multiplicity|2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.||||0.788
71655706|NCT00714493|142829577|SUPERIORITY_OR_OTHER||change from baseline||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71655707|NCT00714493|142829578|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71655708|NCT00251719|142829584|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|2.34||||0.234||95.0|-1.45|6.14||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||6.14|-1.45|0.234
71655709|NCT00251719|142829584|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|4.85||||0.019||95.0|1.2|8.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||8.50|1.20|0.019
71655710|NCT00251719|142829584|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.220
71655711|NCT00251719|142829585|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.768
71655712|NCT00251719|142829585|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.064
71655713|NCT00251719|142829585|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.034
71655714|NCT00251719|142829586|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.727
71655715|NCT00251719|142829586|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.064
71655716|NCT00251719|142829586|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.174
71655717|NCT00251719|142829587|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|1.65||||0.167||95.0|-1.65|4.96||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||4.96|-1.65|0.167
71655718|NCT00251719|142829587|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|3.39||||0.03||95.0|0.27|6.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||6.50|0.27|0.030
71655719|NCT00251719|142829587|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.413
71655720|NCT00251719|142829588|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.100
71655721|NCT00251719|142829588|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.125
71655722|NCT00251719|142829588|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.993
71655723|NCT00251719|142829589|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.117
71711469|NCT03620981|142940071|SUPERIORITY||LS Mean Difference (Final Values)|-3.7||||0.0175|TWO_SIDED|95.0|-6.8|-0.7|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.7|-6.8|0.0175
71711470|NCT03620981|142940072|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.5|-1.0|< 0.0001
71711471|NCT03620981|142940072|SUPERIORITY||LS Mean Difference (Final Values)|-0.3||||0.0083|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.6|0.0083
71711472|NCT03620981|142940073|SUPERIORITY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH), Last observation carried forward (LOCF)||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 10.||-0.6|-1.2|< 0.0001
71826866|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.254|STANDARD_ERROR_OF_MEAN|0.395||0.52|TWO_SIDED|95.0|-1.029|0.521|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.521|-1.029|0.5200
71826867|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.476|STANDARD_ERROR_OF_MEAN|0.332||0.1526|TWO_SIDED|95.0|-1.129|0.177|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.177|-1.129|0.1526
71826868|NCT00383188|143158066|SUPERIORITY||LSM Difference|-1.095|STANDARD_ERROR_OF_MEAN|0.327||0.0009|TWO_SIDED|95.0|-1.738|-0.453|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||-0.453|-1.738|0.0009
71826869|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.523|STANDARD_ERROR_OF_MEAN|0.382||0.1711|TWO_SIDED|95.0|-1.273|0.227|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.227|-1.273|0.1711
71826870|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.563|STANDARD_ERROR_OF_MEAN|0.395||0.1539|TWO_SIDED|95.0|-1.338|0.211|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Intensity Domain of mBPI as the covariate; and participant as a random effect.||0.211|-1.338|0.1539
71826871|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.512|STANDARD_ERROR_OF_MEAN|0.36||0.1554|TWO_SIDED|95.0|-1.219|0.195|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.195|-1.219|0.1554
71826872|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.889|STANDARD_ERROR_OF_MEAN|0.354||0.0124|TWO_SIDED|95.0|-1.585|-0.193|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.193|-1.585|0.0124
71711473|NCT03620981|142940073|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.0052|TWO_SIDED|95.0|-0.8|-0.1|||Cochran-Mantel-Haenszel|CMH, LOCF||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10.||-0.1|-0.8|0.0052
71826873|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.914|STANDARD_ERROR_OF_MEAN|0.412||0.0268|TWO_SIDED|95.0|-1.723|-0.106|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.723|0.0268
71826874|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.681|STANDARD_ERROR_OF_MEAN|0.427||0.1113|TWO_SIDED|95.0|-1.519|0.158|||ANCOVA|||Week 1: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 1 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.158|-1.519|0.1113
71826875|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.1305|TWO_SIDED|95.0|-1.24|0.16|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.160|-1.240|0.1305
71826876|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.571|STANDARD_ERROR_OF_MEAN|0.351||0.1043|TWO_SIDED|95.0|-1.261|0.118|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.118|-1.261|0.1043
71826877|NCT00383188|143158066|SUPERIORITY||LSM Difference|-1.017|STANDARD_ERROR_OF_MEAN|0.409||0.0131|TWO_SIDED|95.0|-1.82|-0.214|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.214|-1.820|0.0131
71826878|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.492|STANDARD_ERROR_OF_MEAN|0.424||0.2459|TWO_SIDED|95.0|-1.324|0.34|||ANCOVA|||Week 2: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 2 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.340|-1.324|0.2459
71826879|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.221|STANDARD_ERROR_OF_MEAN|0.356||0.536|TWO_SIDED|95.0|-0.921|0.479|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.479|-0.921|0.5360
71826880|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.465|STANDARD_ERROR_OF_MEAN|0.351||0.1858|TWO_SIDED|95.0|-1.155|0.225|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.225|-1.155|0.1858
71766069|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|2.99|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.51|3.47||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.47|2.51|<0.001
71711474|NCT04938427|142940097|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-1.17|||=|0.785|TWO_SIDED|95.0|-13.02|9.99||The p-value was calculated using Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) are based on the Hodges-Lehmann estimation.|||9.99|-13.02|=0.785
71711475|NCT04938427|142940098|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|2.43|||=|0.778|TWO_SIDED|95.0|-10.86|15.14||The p-value was calculated using the Rank ANCOVA model using the treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||15.14|-10.86|=0.778
71711476|NCT04938427|142940099|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|0.94|3.87||||||||3.87|0.94|
71711477|NCT04938427|142940100|SUPERIORITY||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.92|4.05||||||||4.05|0.92|
71711478|NCT04938427|142940102|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.86|2.13||||||||2.13|0.86|
71826881|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.821|STANDARD_ERROR_OF_MEAN|0.409||0.0451|TWO_SIDED|95.0|-1.624|-0.018|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.018|-1.624|0.0451
71826882|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.189|STANDARD_ERROR_OF_MEAN|0.424||0.6551|TWO_SIDED|95.0|-1.021|0.643|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.643|-1.021|0.6551
71826883|NCT00383188|143158066|SUPERIORITY||LSM Difference|0.018|STANDARD_ERROR_OF_MEAN|0.356||0.9602|TWO_SIDED|95.0|-0.682|0.718|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.718|-0.682|0.9602
71886750|NCT00523991|143293819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.149||95.0|-5.9|0.9||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.90|-5.90|0.149
71711479|NCT04938427|142940103|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.89|2.21||||||||2.21|0.89|
71711480|NCT04938427|142940104|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.85|2.3||||||Alertness Domain||2.30|0.85|
71711481|NCT04938427|142940104|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.91|2.48||||||Communication Domain||2.48|0.91|
71711482|NCT04938427|142940104|SUPERIORITY||Odds Ratio (OR)|1.91|||||TWO_SIDED|95.0|1.06|3.43||||||Disruptive Behaviors Domain||3.43|1.06|
71711483|NCT04938427|142940105|SUPERIORITY||Least Square Mean Difference|0.52|||||TWO_SIDED|95.0|-2.2|3.24||||||||3.24|-2.20|
71711484|NCT04938427|142940106|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.06|2.65||||||||2.65|1.06|
71711485|NCT04938427|142940107|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.37|||||TWO_SIDED|95.0|-16.83|4.16|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||4.16|-16.83|
71711486|NCT04938427|142940108|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-6.65|||||TWO_SIDED|95.0|-16.67|3.12|||||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI are based on the Hodges-Lehmann estimation.|||3.12|-16.67|
71711487|NCT04938427|142940109|SUPERIORITY||LS Mean Difference|2.47|||||TWO_SIDED|95.0|-1.74|6.67|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||6.67|-1.74|
71711488|NCT04938427|142940110|SUPERIORITY||LS Mean Difference|5.4|||||TWO_SIDED|95.0|1.9|8.9||||||||8.9|1.9|
71711489|NCT04938427|142940111|SUPERIORITY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-3.7|2.0||||||||2.0|-3.7|
71711490|NCT05852470|142940112|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Difference in Means|0.034|STANDARD_ERROR_OF_MEAN|0.0167|||TWO_SIDED|95.0|0.001|0.067||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||0.067|0.001|
71711491|NCT05852470|142940113|SUPERIORITY||Difference in Means|-0.091|STANDARD_ERROR_OF_MEAN|0.0151|<|0.001|TWO_SIDED|95.0|-0.12|-0.061|||t-test, 1 sided||||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|-0.061|-0.120|<.001
71711492|NCT05852470|142940114|SUPERIORITY||Difference in Means|-0.129|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|-0.169|-0.089|||t-test, 1 sided||Parameter Dispersion Type is Standard Error of the Difference in Means. Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL|||-0.089|-0.169|<.001
71711493|NCT05852470|142940115|SUPERIORITY||Difference in Percentages|17.32|||||TWO_SIDED|90.0|8.66||Upper limit is not applicable for testing.|The lower boundary of the confidence interval is reported instead of a p-value.|Miettinen-Nurminen||Difference = Vivity/Vivity Toric Extended Vision IOL minus Clareon/Clareon Toric Monofocal IOL||||8.66|
71711494|NCT01373281|142940117|SUPERIORITY_OR_OTHER_LEGACY||Vaccine efficacy|56.5|||||TWO_SIDED|95.0|43.8|66.4||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||66.4|43.8|
71711495|NCT01373281|142940120|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|55.4|||||TWO_SIDED|95.0|47.3|62.3||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||62.3|47.3|
71711496|NCT01373281|142940121|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|57.9|||||TWO_SIDED|95.0|49.0|65.2||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||65.2|49.0|
71711497|NCT01373281|142940122|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|54.8|||||TWO_SIDED|95.0|46.8|61.7||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||61.7|46.8|
71826884|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.351||0.0198|TWO_SIDED|95.0|-1.51|-0.131|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.131|-1.510|0.0198
71711498|NCT00734032|142940160|SUPERIORITY||Ratio|0.514|||<|0.001|TWO_SIDED|95.0|0.449|0.59|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 40 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.590|0.449|<.001
71711499|NCT00734032|142940160|SUPERIORITY||Ratio|0.421|||<|0.001|TWO_SIDED|95.0|0.367|0.483|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 80 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.483|0.367|<.001
71711500|NCT00734032|142940160|SUPERIORITY||Ratio|0.326|||<|0.001|TWO_SIDED|95.0|0.284|0.375|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 160 mg. Dunnett adjustment was used for comparison of each dose group to placebo.|||0.375|0.284|<.001
71711501|NCT03809000|142940163|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1396|TWO_SIDED|80.0|0.56|0.94|||Log Rank|One-sided significance level = 0.10|Reference level = standard ADT|After protocol amendments, the 3-year PFS rate of the standard arm was expected to be 24%. Assuming a hazard ratio of 0.65 (treatment/control) results in a hypothesized 3-year PFS rate of 39.5% on the enhanced ADT arm. A one-sided log-rank test with alpha=0.10 at 80% statistical power was calculated to require 101 events from 170 patients, taking into account expected accrual rate and follow-up time.||0.94|0.56|0.1396
71711502|NCT03360344|142940176|OTHER|non-parametric tests were used as data was not normally distributed.||||||0.48|||||||Wilcoxan signed Rank|||statistical analysis for wrist||||0.48
71711503|NCT03360344|142940176|OTHER|nonparametric test were used as the distribution was not normal.||||||0.99|||||||Wilcoxan Signed Rank|||statistical analysis for forearm||||.99
71711504|NCT03360344|142940177|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for forearm||||.001
71711505|NCT03360344|142940177|OTHER|||||||0.001|||||||ANOVA|||statistical analysis for wrist||||.001
71655724|NCT00251719|142829589|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.124
71826885|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.948|STANDARD_ERROR_OF_MEAN|0.409||0.0208|TWO_SIDED|95.0|-1.751|-0.145|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.145|-1.751|0.0208
71655725|NCT00251719|142829589|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.949
71711506|NCT03360344|142940178|OTHER|||||||0.06|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.06
71711507|NCT03360344|142940179|OTHER|||||||0.01|||||||ANCOVA|||||||.01
71711508|NCT03360344|142940180|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||.001
71711509|NCT01342666|142940189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1154|STANDARD_ERROR_OF_MEAN|0.9057|<|0.0001|TWO_SIDED|95.0|3.2925|6.9383||We did only one comparison. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||We compare de mean difference of the delta (final-basal levels) between groups. The values posted are the difference found in the tomato group in comparison of the control group. The mean represent the increment of HDL-c in the tomato group.|We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.||6.9383|3.2925|<0.0001
71711510|NCT01342666|142940189|SUPERIORITY_OR_OTHER||Slope|5.656|STANDARD_ERROR_OF_MEAN|0.789|<|0.0001|TWO_SIDED|95.0|4.027|7.232||A priori p value of \<0.05|Regression, Linear|Adjusted for adherence, smoking, age, gender, waist to hip ratio, triglycerides, body mass index, exercise, omega 3, alcohol, fish, simple sugars.|Parameters of the model: F= 4.06; r = 0.798; r2 = 0.638; p=0.001|||7.232|4.027|<0.0001
71711511|NCT04033640|142940201|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
71711512|NCT00600340|142940204|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.042||||0.1983|ONE_SIDED|97.5||1.689||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.689||0.1983
71711513|NCT00600340|142940204|NON_INFERIORITY|"Null hypothesis: Hazard Ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.018||||0.007|ONE_SIDED|97.5||1.261||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.261||0.0070
71826886|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.433|STANDARD_ERROR_OF_MEAN|0.424||0.3077|TWO_SIDED|95.0|-1.265|0.4|||ANCOVA|||Week 8: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 8 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.400|-1.265|0.3077
71826887|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.356||0.555|TWO_SIDED|95.0|-0.911|0.49|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.490|-0.911|0.5550
71826888|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.795|STANDARD_ERROR_OF_MEAN|0.351||0.0239|TWO_SIDED|95.0|-1.485|-0.106|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||-0.106|-1.485|0.0239
71826889|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.613|STANDARD_ERROR_OF_MEAN|0.409||0.1342|TWO_SIDED|95.0|-1.416|0.19|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.190|-1.416|0.1342
71826890|NCT00383188|143158066|SUPERIORITY||LSM Difference|-0.367|STANDARD_ERROR_OF_MEAN|0.424||0.3868|TWO_SIDED|95.0|-1.199|0.465|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline Pain Interference Domain of mBPI as the covariate; and participant as a random effect.||0.465|-1.199|0.3868
71826891|NCT00383188|143158067|SUPERIORITY||LSM Difference|0.792|STANDARD_ERROR_OF_MEAN|1.093||0.4693|TWO_SIDED|95.0|-1.357|2.941|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.941|-1.357|0.4693
71826892|NCT00383188|143158067|SUPERIORITY||LSM Difference|1.927|STANDARD_ERROR_OF_MEAN|1.077||0.0743|TWO_SIDED|95.0|-0.19|4.044|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.044|-0.190|0.0743
71826893|NCT00383188|143158067|SUPERIORITY||LSM Difference|4.196|STANDARD_ERROR_OF_MEAN|1.286||0.0012|TWO_SIDED|95.0|1.668|6.723|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||6.723|1.668|0.0012
71826894|NCT00383188|143158067|SUPERIORITY||LSM Difference|1.236|STANDARD_ERROR_OF_MEAN|1.308||0.3452|TWO_SIDED|95.0|-1.335|3.807|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.807|-1.335|0.3452
71766070|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|3.42|4.41||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||4.41|3.42|<0.001
71766071|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.56|2.52||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.52|1.56|<0.001
71826895|NCT00383188|143158067|SUPERIORITY||LSM Difference|1.095|STANDARD_ERROR_OF_MEAN|1.091||0.3162|TWO_SIDED|95.0|-1.05|3.239|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||3.239|-1.050|0.3162
71655726|NCT02408068|142829602|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|77.56|||||TWO_SIDED|90.0|70.89|84.86|||ANOVA|||Results obtained using a mixed effects ANOVA with fixed effects for study period, sequence, treatment and subject (sequence) (excl. tmax).||84.86|70.89|
71655727|NCT02408068|142829603|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|108.33|||||TWO_SIDED|90.0|102.3|114.72|||ANOVA|||||114.72|102.30|
71655728|NCT02408068|142829604|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.25||||0.0005|TWO_SIDED|95.0|1.25|3.75|||Wilcoxon (Mann-Whitney)|||||3.75|1.25|0.0005
71826896|NCT00383188|143158067|SUPERIORITY||LSM Difference|2.514|STANDARD_ERROR_OF_MEAN|1.072||0.0195|TWO_SIDED|95.0|0.406|4.622|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||4.622|0.406|0.0195
71826897|NCT00383188|143158067|SUPERIORITY||LSM Difference|2.762|STANDARD_ERROR_OF_MEAN|1.283||0.032|TWO_SIDED|95.0|0.239|5.285|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||5.285|0.239|0.0320
71826898|NCT00383188|143158067|SUPERIORITY||LSM Difference|0.268|STANDARD_ERROR_OF_MEAN|1.29||0.8356|TWO_SIDED|95.0|-2.268|2.804|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 PCS as the covariate; and participant as a random effect.||2.804|-2.268|0.8356
71826899|NCT00383188|143158067|SUPERIORITY||LSM Difference|-0.904|STANDARD_ERROR_OF_MEAN|1.626||0.5787|TWO_SIDED|95.0|-4.101|2.293|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||2.293|-4.101|0.5787
71711514|NCT00600340|142940204|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.2024|ONE_SIDED|97.5||1.674||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.674||0.2024
71711515|NCT00600340|142940204|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.134||||0.0612|ONE_SIDED|97.5||1.386||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.386||0.0612
71711516|NCT00600340|142940205|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.027||||0.1534|ONE_SIDED|97.5||1.606||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).||1.606||0.1534
71711517|NCT00600340|142940205|NON_INFERIORITY|"Null hypothesis: Hazard ratio (HR) \>= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"|Hazard Ratio (HR)|1.035||||0.0085|ONE_SIDED|97.5||1.273||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).||1.273||0.0085
71711518|NCT00600340|142940205|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.1778|ONE_SIDED|97.5||1.623||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).||1.623||0.1778
71711519|NCT00600340|142940205|NON_INFERIORITY|Null hypothesis: Hazard Ratio (HR) \>= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.126||||0.049|ONE_SIDED|97.5||1.37||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).||1.37||0.049
71711520|NCT00600340|142940211|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR) of objective response and Cochran-Mantel-Haenszel (CMH) test (stratified)||0.67|0.33|< 0.0001
71711521|NCT00600340|142940211|SUPERIORITY||Risk Difference (RD)|-17.0|||||TWO_SIDED|95.0|-24.0|-9.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-9|-24|
71711522|NCT00600340|142940211|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
71711523|NCT00600340|142940211|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
71711524|NCT00600340|142940212|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.65|0.31|< 0.0001
71711525|NCT00600340|142940212|SUPERIORITY||Risk Difference (RD)|-18.0|||||TWO_SIDED|95.0|-26.0|-10.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-10|-26|
71766072|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.34|2.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.31|1.34|<0.001
71826900|NCT00383188|143158067|SUPERIORITY||LSM Difference|1.291|STANDARD_ERROR_OF_MEAN|1.6||0.4203|TWO_SIDED|95.0|-1.854|4.436|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.436|-1.854|0.4203
71826901|NCT00383188|143158067|SUPERIORITY||LSM Difference|2.318|STANDARD_ERROR_OF_MEAN|1.916||0.2272|TWO_SIDED|95.0|-1.449|6.084|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.084|-1.449|0.2272
71826902|NCT00383188|143158067|SUPERIORITY||LSM Difference|0.829|STANDARD_ERROR_OF_MEAN|1.947||0.6707|TWO_SIDED|95.0|-2.998|4.655|||ANCOVA|||Week 4: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 4 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||4.655|-2.998|0.6707
71826903|NCT00383188|143158067|SUPERIORITY||LSM Difference|0.425|STANDARD_ERROR_OF_MEAN|1.622||0.7935|TWO_SIDED|95.0|-2.764|3.613|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||3.613|-2.764|0.7935
71826904|NCT00383188|143158067|SUPERIORITY||LSM Difference|2.525|STANDARD_ERROR_OF_MEAN|1.592||0.1135|TWO_SIDED|95.0|-0.605|5.655|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.655|-0.605|0.1135
71826905|NCT00383188|143158067|SUPERIORITY||LSM Difference|2.63|STANDARD_ERROR_OF_MEAN|1.912||0.1697|TWO_SIDED|95.0|-1.128|6.388|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||6.388|-1.128|0.1697
71826906|NCT00383188|143158067|SUPERIORITY||LSM Difference|2.21|STANDARD_ERROR_OF_MEAN|1.918||0.25|TWO_SIDED|95.0|-1.561|5.981|||ANCOVA|||Week 12: Estimates and p-values based on repeated measures analysis of covariance with treatment, country and week as fixed effects, treatment Week 12 as an interaction term, baseline SF-36 MCS as the covariate; and participant as a random effect.||5.981|-1.561|0.2500
71826907|NCT02476890|143158076|OTHER||Mean Difference (Final Values)|0.01||||0.9666|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||C2 Response/Healthy||0.7|-0.6|0.9666
71826908|NCT02476890|143158076|OTHER||Mean Difference (Final Values)|-0.22||||0.5993|TWO_SIDED|95.0|-1.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-1.1|0.5993
71655729|NCT02408068|142829605|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|83.27|||||TWO_SIDED|90.0|75.58|91.74||||||||91.74|75.58|
71655730|NCT02408068|142829606|SUPERIORITY_OR_OTHER_LEGACY||Geometric LSmean ratio|118.83|||||TWO_SIDED|90.0|111.58|126.54||||||||126.54|111.58|
71655731|NCT02408068|142829607|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.5||||0.0014|TWO_SIDED|95.0|2.25|4.38|||Wilcoxon (Mann-Whitney)|||||4.38|2.25|0.0014
71655732|NCT02623348|142829618|SUPERIORITY||||||<|0.01||||||Threshold for significance: \<0.05|linear mixed modeling|||||||<0.01
71655733|NCT00706381|142829636|SUPERIORITY||Percent change from placebo|7.87|STANDARD_DEVIATION|9.2||0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.0001
71655734|NCT00706381|142829636|SUPERIORITY||Percent change from placebo|9.25|STANDARD_DEVIATION|8.3|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
71655735|NCT00706381|142829636|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|6.2||0.89|TWO_SIDED||||||Percent change from placebo|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.89
71655736|NCT00706381|142829636|SUPERIORITY||Percent change from placebo|-0.3|STANDARD_DEVIATION|7.2||0.41|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.41
71655737|NCT00706381|142829637|SUPERIORITY||Percent change from placebo|40.0|STANDARD_DEVIATION|72.8||0.096|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.096
71655738|NCT00706381|142829637|SUPERIORITY||Percent change from placebo|260.4|STANDARD_DEVIATION|191.7|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
71655739|NCT00706381|142829637|SUPERIORITY||Percent change from placebo|16.4|STANDARD_DEVIATION|56.3||0.83|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||0.83
71655740|NCT00706381|142829637|SUPERIORITY||Percent change from placebo|125.7|STANDARD_DEVIATION|92.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||The percent change from placebo was calculated for each participant and then a t-test was used to test the null hypothesis that this difference was equal to 0.||||<0.0001
71655741|NCT02749292|142829672|EQUIVALENCE|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|0.37||||0.045|TWO_SIDED|95.0|0.15|0.9|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant. Both rows were included and combined in the statistical analysis (ANCA-PR3 and ANCA-MPO) to assess the difference in treatment strategies.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses."||0.90|0.15|0.045
71655742|NCT02749292|142829673|OTHER|chi square test||||||0.87|||||||Chi-squared|||"Null hypothesis: No difference in the proportion of patients with SAEs in each arm"||||0.87
71655743|NCT02749292|142829678|OTHER||||||<|1|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: no difference in the mean number of infusions per patient in each arm.||||<0001
71655744|NCT02749292|142829679|OTHER||Mean Difference (Final Values)|-0.14||||0.17|TWO_SIDED|95.0|-0.34|-0.06|||t-test, 2 sided|||Null hypothesis: there is no difference in the mean change from baseline Vasculitis Damage Index between each arm. A t-test was used.||-0.06|-0.34|0.17
71655745|NCT02749292|142829680|OTHER|Using a two-sided log-rank test with an alpha level of 0.05, a projected relapse risk of 15% in the superior group and 30% in the inferior group, and an estimated enrollment time of 36 months, it was determined that 200 patients were required to detect a significant difference with a power of 0.80. Due to the coronavirus disease 2019 (COVID-19) pandemic and the deleterious impact of rituximab on vaccination efficacy, the trial was concluded before reaching the target enrollment of 200.|Hazard Ratio (HR)|1.64||||0.42|TWO_SIDED|95.0|0.5|5.36|||Log Rank|||"The difference between the two treatment strategies was assessed using the log-rank test. P values of 0.05 were considered significant.~Null hypothesis: No difference in the ANCA and B-cell arm in the probability of relapses"||5.36|0.50|0.42
71655746|NCT00251641|142829688|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|Pearson's chi-square test||The treatment comparison for this endpoint was carried at the 4.9% level of significance.||||<0.001
71655747|NCT00251641|142829689|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
71655748|NCT00251641|142829690|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
71711526|NCT00600340|142940212|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
71655749|NCT00251641|142829691|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test||||||<0.001
71655750|NCT04017754|142829699|EQUIVALENCE|A p-value \<0.05 was considered significant for at difference in frequency of low p-MBL level(\<500 ug/l) between groups.|Prevalence proportion ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.34|2.38|||Chi-squared||The numerator is the risk of low p-MBL in the study sample with RPL patients and the denominator is the risk of low p-MBL in control group 1 of female blood donors.|Comparing the risk of low p-MBL level between RPL patients and MBL reference group. We hypothesized that more RPL patients had a low p-MBL level; thus, the null hypothesis was that no difference existed.||2.38|1.34|<0.001
71655751|NCT00534794|142829742|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|||ITT (Intent to Treat)||||0.532
71655752|NCT00534794|142829743|SUPERIORITY_OR_OTHER|||||||0.927||95.0|||||Student's t-test|||ITT (Intent to Treat)||||0.927
71655753|NCT04932941|142829746|SUPERIORITY||Common risk difference|-0.276||||0.962|TWO_SIDED|95.0|-11.634|11.081|||Mantel Haenszel||Strata-adjusted Mantel Haenszel (MH) method for difference in proportions controlling for stratification factors (COVID-19 severity: moderate, severe, and age group: less than or equal to 65 years, greater than 65 years).|||11.081|-11.634|0.962
71655754|NCT01929031|142829773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.738|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|33.767|49.708|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||49.708|33.767|<0.0001
71655755|NCT01929031|142829773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.467|STANDARD_ERROR_OF_MEAN|4.058|<|0.0001|TWO_SIDED|95.0|28.497|44.437|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||44.437|28.497|<0.0001
71655756|NCT01929031|142829773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.126|STANDARD_ERROR_OF_MEAN|2.868|<|0.0001|TWO_SIDED|95.0|6.493|17.759|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||17.759|6.493|<0.0001
71655757|NCT01929031|142829774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.525|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.937|10.113|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo|||10.113|6.937|<0.0001
71655758|NCT01929031|142829774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.972|STANDARD_ERROR_OF_MEAN|0.808|<|0.0001|TWO_SIDED|95.0|6.384|9.559|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine|||9.559|6.384|<0.0001
71655759|NCT01929031|142829774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.594|STANDARD_ERROR_OF_MEAN|0.571|<|0.0001|TWO_SIDED|95.0|2.472|4.716|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen|||4.716|2.472|<0.0001
71655760|NCT01929031|142829775|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
71655761|NCT01929031|142829775|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
71655762|NCT01929031|142829775|SUPERIORITY_OR_OTHER|||||||0.2389|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.2389
71655763|NCT01929031|142829776|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo||||<0.0001
71655764|NCT01929031|142829776|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine||||<0.0001
71655765|NCT01929031|142829776|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen||||0.0001
71711527|NCT00600340|142940212|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
71711528|NCT00600340|142940213|SUPERIORITY|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.63|0.31|< 0.0001
71711529|NCT00600340|142940213|SUPERIORITY||Risk Difference (RD)|-20.0|||||TWO_SIDED|95.0|-28.0|-11.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-11|-28|
71711530|NCT00600340|142940213|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0006|TWO_SIDED|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.70|0.27|0.0006
71711531|NCT00600340|142940213|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-18.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-18|
71711532|NCT00600340|142940214|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.6||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)||0.60|0.29|< 0.0001
71826909|NCT02476890|143158076|OTHER||Mean Difference (Final Values)|0.32||||0.2823|TWO_SIDED|95.0|-0.3|0.9|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.9|-0.3|0.2823
71826910|NCT02476890|143158076|OTHER||Mean Difference (Final Values)|0.25||||0.4287|TWO_SIDED|95.0|-0.4|0.9|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.9|-0.4|0.4287
71826911|NCT02476890|143158077|OTHER||Mean Difference (Final Values)|0.56||||0.1771|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||C2 Response/Healthy||1.4|-0.3|0.1771
71826912|NCT02476890|143158077|OTHER||Mean Difference (Final Values)|0.3||||0.5473|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||C5 Response/Healthy||1.3|-0.7|0.5473
71711533|NCT00600340|142940214|SUPERIORITY||Risk Difference (RD)|-21.0|||||TWO_SIDED|95.0|-30.0|-13.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-13|-30|
71886751|NCT00523991|143293820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.763||95.0|-4.0|2.93||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.93|-4.00|0.763
71711534|NCT00600340|142940214|SUPERIORITY|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|TWO_SIDED|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)||0.65|0.24|0.0003
71711535|NCT00600340|142940214|SUPERIORITY||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-19.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel||-6|-19|
71826913|NCT02476890|143158077|OTHER||Mean Difference (Final Values)|0.23||||0.5169|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||C2 Response/Chronic Cough||1.0|-0.5|0.5169
71826914|NCT02476890|143158077|OTHER||Mean Difference (Final Values)|0.28||||0.4243|TWO_SIDED|95.0|-0.4|1.0|||Mixed Models Analysis|||C5 Response/Chronic Cough||1.0|-0.4|0.4243
71826915|NCT02476890|143158078|OTHER||Mean Difference (Final Values)|0.89||||0.1125|TWO_SIDED|95.0|-0.2|2.0|||Mixed Models Analysis|||C2 Response/Healthy||2.0|-0.2|0.1125
71826916|NCT02476890|143158078|OTHER||Mean Difference (Final Values)|0.88||||0.0029|TWO_SIDED|95.0|0.4|1.4|||Mixed Models Analysis|||C5 Response/Healthy||1.4|0.4|0.0029
71826917|NCT02476890|143158078|OTHER||Mean Difference (Final Values)|1.54||||0.0006|TWO_SIDED|95.0|0.7|2.4|||Mixed Models Analysis|||C2 Response/Chronic Cough||2.4|0.7|0.0006
71826918|NCT02476890|143158078|OTHER||Mean Difference (Final Values)|1.3||||0.0067|TWO_SIDED|95.0|0.4|2.2|||Mixed Models Analysis|||C5 Response/Chronic Cough||2.2|0.4|0.0067
71826919|NCT02476890|143158079|OTHER||Mean Difference (Final Values)|0.38|||<|0.0001|TWO_SIDED|95.0|0.2|0.5|||Mixed Models Analysis|||C2 Response/Healthy||0.5|0.2|< 0.0001
71826920|NCT02476890|143158079|OTHER||Mean Difference (Final Values)|0.23||||0.1798|TWO_SIDED|95.0|-0.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy||0.6|-0.1|0.1798
71826921|NCT02476890|143158079|OTHER||Mean Difference (Final Values)|0.3||||0.0011|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||C2 Response/Chronic Cough||0.5|0.1|0.0011
71826922|NCT02476890|143158079|OTHER||Mean Difference (Final Values)|0.28||||0.0023|TWO_SIDED|95.0|0.1|0.4|||Mixed Models Analysis|||C5 Response/Chronic Cough||0.4|0.1|0.0023
71826923|NCT02476890|143158080|OTHER||Mean Difference (Final Values)|-18.0||||0.0037|TWO_SIDED|95.0|-29.8|-6.2|||Mixed Models Analysis|||Cough Severity VAS Analysis||-6.2|-29.8|0.0037
71826924|NCT02476890|143158081|OTHER||Mean Difference (Final Values)|-18.0||||0.002|TWO_SIDED|95.0|-29.1|-7.0|||Mixed Models Analysis|||Urge to Cough VAS Analysis||-7.0|-29.1|0.0020
71826925|NCT02476890|143158082|OTHER||Mean Difference (Final Values)|-3.6||||0.0075|TWO_SIDED|95.0|-6.2|-1.0|||Mixed Models Analysis|||Cough Frequency Analysis||-1.0|-6.2|0.0075
71826926|NCT00835380|143158085|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.0||||||95.0|89.0|99.0||||||||99|89|
71826927|NCT03247543|143158087|SUPERIORITY||Least Square Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.05||0.0038|TWO_SIDED|95.0|-10.0|-1.9|||Mixed Models for Repeated Measures|||||-1.9|-10.0|0.0038
71826928|NCT03247543|143158087|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.11||0.0063|TWO_SIDED|95.0|-9.9|-1.7|||Mixed Models for Repeated Measures|||||-1.7|-9.9|0.0063
71826929|NCT03247543|143158088|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0028|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.8|0.0028
71826930|NCT03247543|143158088|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0099|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0099
71826931|NCT03247543|143158089|SUPERIORITY||Least Square Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.0064|TWO_SIDED|95.0|-6.5|-1.1|||ANCOVA|||||-1.1|-6.5|0.0064
71826932|NCT03247543|143158089|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.46||0.0917|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.0917
71826933|NCT03247543|143158090|SUPERIORITY||Least Square Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.059||0.0651|TWO_SIDED|95.0|-0.22|0.01|||ANCOVA|||||0.01|-0.22|0.0651
71826934|NCT03247543|143158090|SUPERIORITY||Least Square Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.061||0.168|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||||0.04|-0.20|0.1680
71711536|NCT00600340|142940215|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.32||||0.0066|TWO_SIDED|95.0|1.08|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.08|0.0066
71711537|NCT00600340|142940216|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.31||||0.0094|TWO_SIDED|95.0|1.07|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.61|1.07|0.0094
71766073|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|2.34|3.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.31|2.34|<0.001
71826935|NCT03247543|143158091|SUPERIORITY||Risk Difference (RD)|10.1||||0.1316|TWO_SIDED|95.0|-2.9|23.1|||Regression, Logistic|||||23.1|-2.9|0.1316
71826936|NCT03247543|143158091|SUPERIORITY||Risk Difference (RD)|15.4||||0.0276|TWO_SIDED|95.0|2.0|28.9|||Regression, Logistic|||||28.9|2.0|0.0276
71826937|NCT03247543|143158092|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.7||0.2128|TWO_SIDED|95.0|-8.7|1.9|||ANCOVA|||||1.9|-8.7|0.2128
71826938|NCT03247543|143158092|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.83||0.0409|TWO_SIDED|95.0|-11.3|-0.2|||ANCOVA|||||-0.2|-11.3|0.0409
71826939|NCT03247543|143158093|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|-5.4|-1.2|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.2|-5.4|0.0020
71826940|NCT03247543|143158093|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.09||0.0039|TWO_SIDED|95.0|-5.3|-1.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.0|-5.3|0.0039
71826941|NCT03247543|143158093|SUPERIORITY||Least Square Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.05||0.0087|TWO_SIDED|95.0|-4.8|-0.7|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.7|-4.8|0.0087
71826942|NCT03247543|143158093|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0248|TWO_SIDED|95.0|-4.6|-0.3|||ANCOVA|||This analysis pertains to the Inattention subscale score||-0.3|-4.6|0.0248
71826943|NCT03247543|143158094|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.43||0.7003|TWO_SIDED|95.0|-3.3|2.2|||ANCOVA|||||2.2|-3.3|0.7003
71826944|NCT03247543|143158094|SUPERIORITY||Least Square Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45||0.1602|TWO_SIDED|95.0|-4.9|0.8|||ANCOVA|||||0.8|-4.9|0.1602
71826945|NCT03247543|143158095|SUPERIORITY|||||||0.0236|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0236
71826946|NCT03247543|143158095|SUPERIORITY|||||||0.0505|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0505
71826947|NCT03247543|143158095|SUPERIORITY|||||||0.1225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.1225
71826948|NCT03247543|143158095|SUPERIORITY|||||||0.0254|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.0254
71826949|NCT03247543|143158095|SUPERIORITY|||||||0.0261|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.0261
71826950|NCT03247543|143158095|SUPERIORITY|||||||0.0037|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0037
71826951|NCT03247543|143158095|SUPERIORITY|||||||0.0385|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.0385
71826952|NCT03247543|143158095|SUPERIORITY|||||||0.0956|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0956
71826953|NCT03247543|143158095|SUPERIORITY|||||||0.0962|||||||Chi-squared|||This analysis pertains to Week 1 of treatment.||||0.0962
71826954|NCT03247543|143158095|SUPERIORITY|||||||0.0744|||||||Chi-squared|||This analysis pertains to Week 2 of treatment.||||0.0744
71711538|NCT00600340|142940217|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.13||||0.1957|TWO_SIDED|95.0|0.94|1.35||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.35|0.94|0.1957
71711539|NCT00600340|142940218|SUPERIORITY|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.11||||0.2583|TWO_SIDED|95.0|0.92|1.34||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||1.34|0.92|0.2583
71711540|NCT00600340|142940219|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.43|0.77||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.77|0.43|0.0001
71711541|NCT00600340|142940220|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.56||||0.0001|TWO_SIDED|95.0|0.41|0.75||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||0.75|0.41|0.0001
71711542|NCT00600340|142940221|SUPERIORITY|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.41||||0.0582|TWO_SIDED|95.0|0.99|2.02||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.02|0.99|0.0582
71711543|NCT00600340|142940222|SUPERIORITY|HR is the hazard rate of Arm B divided by hazard rate of Arm A.|Hazard Ratio (HR)|1.45||||0.0429|TWO_SIDED|95.0|1.01|2.1||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Arm B divided by hazard rate of Arm A.|"HR of Arm B vs. Arm A for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~1. estrogen and/or progesterone status (positive vs. other)~2. country~3. menopausal status (premenopausal or male \<=50 years of age vs. postmenopausal or male \>50 years of age)"||2.10|1.01|0.0429
71711544|NCT02314923|142940231|OTHER|||||||0.951|||||||ANOVA|||||||0.951
71711545|NCT02314923|142940231|OTHER|||||||0.458|||||||ANOVA|||||||0.458
71711546|NCT02314923|142940231|OTHER|||||||0.071|||||||ANOVA|||||||0.071
71711547|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711548|NCT02314923|142940231|OTHER|||||||0.029|||||||ANOVA|||||||0.029
71711549|NCT02314923|142940231|OTHER|||||||0.325|||||||ANOVA|||||||0.325
71711550|NCT02314923|142940231|OTHER|||||||0.003|||||||ANOVA|||||||0.003
71766074|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|3.24|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|90.0|2.74|3.73||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||3.73|2.74|<0.001
71711551|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711552|NCT02314923|142940231|OTHER|||||||0.427|||||||ANOVA|||||||0.427
71711553|NCT02314923|142940231|OTHER|||||||0.065|||||||ANOVA|||||||0.065
71711554|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711555|NCT02314923|142940231|OTHER|||||||0.027|||||||ANOVA|||||||0.027
71711556|NCT02314923|142940231|OTHER|||||||0.303|||||||ANOVA|||||||0.303
71711557|NCT02314923|142940231|OTHER|||||||0.003|||||||ANOVA|||||||0.003
71711558|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711559|NCT02314923|142940231|OTHER|||||||0.286|||||||ANOVA|||||||0.286
71711560|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711561|NCT02314923|142940231|OTHER|||||||0.094|||||||ANOVA|||||||0.094
71711562|NCT02314923|142940231|OTHER|||||||0.757|||||||ANOVA|||||||0.757
71711563|NCT02314923|142940231|OTHER|||||||0.022|||||||ANOVA|||||||0.022
71711564|NCT02314923|142940231|OTHER|||||||0.001|||||||ANOVA|||||||0.001
71711565|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711566|NCT02314923|142940231|OTHER|||||||0.348|||||||ANOVA|||||||0.348
71711567|NCT02314923|142940231|OTHER|||||||0.508|||||||ANOVA|||||||0.508
71711568|NCT02314923|142940231|OTHER|||||||0.191|||||||ANOVA|||||||0.191
71711569|NCT02314923|142940231|OTHER|||||||0.024|||||||ANOVA|||||||0.024
71711570|NCT02314923|142940231|OTHER|||||||0.169|||||||ANOVA|||||||0.169
71711571|NCT02314923|142940231|OTHER|||||||0.961|||||||ANOVA|||||||0.961
71711572|NCT02314923|142940231|OTHER|||||||0.454|||||||ANOVA|||||||0.454
71826955|NCT03247543|143158095|SUPERIORITY|||||||0.0218|||||||Chi-squared|||This analysis pertains to Week 3 of treatment.||||0.0218
71826956|NCT03247543|143158095|SUPERIORITY|||||||0.115|||||||Chi-squared|||This analysis pertains to Week 4 of treatment.||||0.1150
71826957|NCT03247543|143158095|SUPERIORITY|||||||0.1086|||||||Chi-squared|||This analysis pertains to Week 5 of treatment.||||0.1086
71826958|NCT03247543|143158095|SUPERIORITY|||||||0.0082|||||||Chi-squared|||This analysis pertains to Week 6 of treatment.||||0.0082
71826959|NCT03247543|143158095|SUPERIORITY|||||||0.2326|||||||Chi-squared|||This analysis pertains to Week 7 of treatment.||||0.2326
71826960|NCT03247543|143158095|SUPERIORITY|||||||0.0883|||||||Chi-squared|||This analysis pertains to Week 8 of treatment.||||0.0883
71826961|NCT01097343|143158096|SUPERIORITY_OR_OTHER||||||=|0.02|TWO_SIDED|95.0|||||Chi-squared|||A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as \>230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05||||=0.02
71711573|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711574|NCT02314923|142940231|OTHER|||||||0.068|||||||ANOVA|||||||0.068
71711575|NCT02314923|142940231|OTHER|||||||0.007|||||||ANOVA|||||||0.007
71826962|NCT02059980|143158097|SUPERIORITY||||||=|0.56|||||||Mixed Models Analysis|||It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||= 0.56
71826963|NCT02059980|143158098|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).||||=.98
71826964|NCT01227707|143158169|SUPERIORITY_OR_OTHER|||||||1|||||||one sample binomial test|||||||1.00
71826965|NCT00414206|143158182|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
71826966|NCT01726023|143158183|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.|Risk Difference (RD)|-0.2|||<|0.001|TWO_SIDED|95.0|-5.53|4.97||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.|% Risk Difference (RD)|RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|units for RD are %|The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.||4.97|-5.53|<0.001
71826967|NCT01726023|143158216|SUPERIORITY_OR_OTHER||Difference in median time (days)|0.5||||0.773|||||||Log Rank|||||||0.773
71826968|NCT01726023|143158217|SUPERIORITY_OR_OTHER||Difference in median time (days)|1.0||||0.598|||||||Log Rank|||||||0.598
71711576|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711577|NCT02314923|142940231|OTHER|||||||0.37|||||||ANOVA|||||||0.370
71711578|NCT02314923|142940231|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71711579|NCT00725985|142940236|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.248|0.584||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.584|0.248|<0.0001
71711580|NCT00725985|142940236|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.327|||<|0.0001|TWO_SIDED|95.0|0.21|0.509||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.509|0.210|< 0.0001
71711581|NCT00725985|142940237|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.331|0.547||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.547|0.331|< 0.0001
71826969|NCT01093534|143158243|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.169||||0.095|TWO_SIDED|95.0|-0.368|0.03||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|ANCOVA|ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.||The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)||0.030|-0.368|0.095
71826970|NCT01093534|143158244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|Wilcoxon (Mann-Whitney)|Nonparametric Wilcoxon rank-sum test does not adjust for other factors.||The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).||||0.250
71826971|NCT03028363|143158268|OTHER|||||||0.343|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.3430
71826972|NCT03028363|143158269|OTHER|||||||0.126|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.1260
71826973|NCT03028363|143158270|OTHER|||||||0.5247|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.5247
71826974|NCT00281918|143158271|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
71826975|NCT00281918|143158272|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<.0001
71826976|NCT00281918|143158273|SUPERIORITY_OR_OTHER|||||||0.0427||95.0|||||Log Rank|||||||0.0427
71826977|NCT00281918|143158274|SUPERIORITY_OR_OTHER|||||||0.7882||95.0|||||Log Rank|||||||0.7882
71826978|NCT00281918|143158275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
71711582|NCT00725985|142940237|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.497|||<|0.0001|TWO_SIDED|95.0|0.39|0.633||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test|||||0.633|0.390|< 0.0001
71711583|NCT00725985|142940238|SUPERIORITY||Median Difference (Final Values)|-0.667|||<|0.0001|TWO_SIDED|95.0|-0.971|-0.5|||ANCOVA|||CUA lesions||-0.500|-0.971|<0.0001
71711584|NCT00725985|142940238|SUPERIORITY||Median Difference (Final Values)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.857|-0.429|||ANCOVA|||CUA lesions||-0.429|-0.857|<0.0001
71711585|NCT00725985|142940238|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.333|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.333|<0.0001
71826979|NCT00281918|143158276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.001|TWO_SIDED|95.0|0.54|0.86|||Log Rank|||||0.86|0.54|0.0010
71826980|NCT00281918|143158277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.48|0.67|||Log Rank|||||0.67|0.48|<.0001
71711586|NCT00725985|142940238|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.375|-0.167|||ANCOVA|||T1 Gd-Enhancing Lesions||-0.167|-0.375|<0.0001
71711587|NCT00725985|142940238|SUPERIORITY||Median Difference (Final Values)|-0.333|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.167|||ANCOVA|||T2 Lesions||-0.167|-0.500|<0.0001
71711588|NCT00725985|142940238|SUPERIORITY||Median Difference (Final Values)|-0.286|||<|0.0001|TWO_SIDED|95.0|-0.429|-0.143|||ANCOVA|||T2 Lesions||-0.143|-0.429|<0.0001
71711589|NCT00725985|142940257|SUPERIORITY||Point Estimate|-1.7|||<|0.0001|TWO_SIDED|95.0|-37.2|0.0|||ANCOVA|||||0.000|-37.200|<0.0001
71711590|NCT00725985|142940257|SUPERIORITY||Point Estimate|-28.6|||<|0.0001|TWO_SIDED|95.0|-117.3|0.0|||ANCOVA|||||0.000|-117.300|<0.0001
71711591|NCT00863304|142940286|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.65|-0.62||P-value was based on pairwise comparisons.|ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.62|-1.65|<0.001
71711592|NCT00863304|142940286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.32|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.32|0.002
71711593|NCT00863304|142940286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.09|TWO_SIDED|95.0|-0.96|0.07||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.96|0.090
71711594|NCT00863304|142940286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.26||0.009|TWO_SIDED|95.0|-1.21|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-1.21|0.009
71711595|NCT00863304|142940286|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.26||0.175|TWO_SIDED|95.0|-0.87|0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.87|0.175
71711596|NCT00863304|142940287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.71|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.71|<0.001
71711597|NCT00863304|142940287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.48|-0.51||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.51|-1.48|<0.001
71711598|NCT00863304|142940287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.067|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.067
71711599|NCT00863304|142940287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.25||0.002|TWO_SIDED|95.0|-1.26|-0.29||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.29|-1.26|0.002
71826981|NCT00281918|143158278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0523|TWO_SIDED|95.0|0.52|1.02|||Log Rank|||||1.02|0.52|0.0523
71826982|NCT00281918|143158279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.71|||Log Rank|||||0.71|0.48|<.0001
71826983|NCT00281918|143158280|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.62|3.28|||Chi-squared|||||3.28|1.62|<.0001
71826984|NCT00281918|143158281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.72|||Log Rank|||||0.72|0.49|<.0001
71826985|NCT01199237|143158282|SUPERIORITY_OR_OTHER|||||||0.11||||||Significant at p\<0.05|Chi-squared|||||||0.11
71826986|NCT01670110|143158305|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71826987|NCT01670110|143158306|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
71826988|NCT01670110|143158307|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71826989|NCT01670110|143158308|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71826990|NCT01670110|143158309|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71826991|NCT01670110|143158310|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71826992|NCT01670110|143158311|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71826993|NCT01670110|143158312|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Physical functioning||||0.31
71711600|NCT00863304|142940287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.031|TWO_SIDED|95.0|-1.03|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-1.03|0.031
71711601|NCT00863304|142940288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.50|<0.001
71711602|NCT00863304|142940288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-0.48|<0.001
71711603|NCT00863304|142940288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.078|TWO_SIDED|95.0|-0.3|0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.02|-0.30|0.078
71711604|NCT00863304|142940288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.019
71711605|NCT00863304|142940288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.029
71711606|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
71711607|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
71711608|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
71766075|NCT01375075|143034039|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|90.0|1.65|2.63||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||2.63|1.65|<0.001
71711609|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
71711610|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
71711611|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.63|<0.001
71711612|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.49|-1.42|<0.001
71711613|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.007|TWO_SIDED|95.0|-1.11|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-1.11|0.007
71826994|NCT01670110|143158312|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Physical role||||0.48
71826995|NCT01670110|143158312|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Bodily pain||||0.89
71711614|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.029|TWO_SIDED|95.0|-0.99|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.99|0.029
71711615|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.193|TWO_SIDED|95.0|-0.78|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.78|0.193
71711616|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.68|-0.73||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.73|-1.68|<0.001
71826996|NCT01670110|143158312|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||General health||||0.18
71826997|NCT01670110|143158312|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Vitality||||0.28
71826998|NCT01670110|143158312|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Social functioning||||0.66
71826999|NCT01670110|143158312|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Role emotional||||0.43
71827000|NCT01670110|143158312|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Mental health||||0.51
71655766|NCT00321594|142829777|OTHER||Maximum Tolerated Dose|1400.0|||||TWO_SIDED||||||||MTD was not reached and the maximum dose of 1400 mg/m2 is used in Phase II portion|MTD is defined as the dose below which \>=2 of 3 or \>= 2 of 6 patients experience DLT||||
71711617|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.24||0.001|TWO_SIDED|95.0|-1.28|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.28|0.001
71655767|NCT03222583|142829857|NON_INFERIORITY|The percentage of participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 96% if the lower confidence bound (LCB) of the 2-sided 95% confidence interval (CI) for the percentage was \> 90%.|Percentage of Participants with SVR12|97.2|||||TWO_SIDED|95.0|95.5|98.9||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||98.9|95.5|
71655768|NCT03222583|142829858|NON_INFERIORITY|The percentage of GT1-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 97% if the LCB of the 2-sided 95% CI for the percentage was \> 91%.|Percentage of Participants with SVR12|99.4|||||TWO_SIDED|95.0|98.3|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|98.3|
71655769|NCT03222583|142829859|NON_INFERIORITY|The percentage of GT2-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 95% if the LCB of the 2-sided 95% CI for the percentage was \> 89%.|Percentage of Participants with SVR12|97.8|||||TWO_SIDED|95.0|95.4|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.||100.0|95.4|
71655770|NCT03573505|142829865|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.112|TWO_SIDED|95.0|0.85|4.73|||Log Rank|||A cox proportional hazards model with terms for treatment (BG00011 vs. placebo) and randomization stratification factor is used. A stratified log-rank test is used to compare the 2 treatment groups using randomization stratus as the stratification factor. An HR (Hazard Ratio) \< 1 indicates lower risk of event for the BG00011 group where HR is based on Cox proportional hazard model with treatment (Placebo, BG00011) as the categorical covariate.||4.73|0.85|0.112
71655771|NCT04280705|142829883|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.49|||Log Rank|||||1.49|1.12|<0.001
71655772|NCT04280705|142829907|SUPERIORITY|||||||0.058|||||||Barnard's Exact Test|||||||0.058
71655773|NCT04280705|142829908|SUPERIORITY|||||||0.01|||||||Barnard's Exact Test|||||||0.010
71655774|NCT04280705|142829920|SUPERIORITY||Cox Proportional Hazard|1.23||||0.002|TWO_SIDED|95.0|1.08|1.41|||Log Rank|||||1.41|1.08|0.002
71711618|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.011|TWO_SIDED|95.0|-1.1|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.10|0.011
71711619|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.06|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.06|0.017
71711620|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.24||0.464|TWO_SIDED|95.0|-0.66|0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.30|-0.66|0.464
71711621|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.72|-0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.72|-1.72|<0.001
71711622|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.55|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.55|<0.001
71711623|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.26||0.014|TWO_SIDED|95.0|-1.14|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.14|0.014
71711624|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.26||0.023|TWO_SIDED|95.0|-1.09|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.09|0.023
71655775|NCT04280705|142829921|SUPERIORITY||Cox Proportional Hazard|1.29|||<|0.001|TWO_SIDED|95.0|1.12|1.48|||Log Rank|||||1.48|1.12|<0.001
71655776|NCT04280705|142829922|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.001|TWO_SIDED|95.0|1.1|1.46|||Log Rank|||||1.46|1.10|<0.001
71655777|NCT04280705|142829923|SUPERIORITY||Cox Proportional Hazard|1.07|||||TWO_SIDED|95.0|0.73|1.58||||||This analysis is for Asian participants||1.58|0.73|
71655778|NCT04280705|142829923|SUPERIORITY||Cox Proportional Hazard|1.25|||||TWO_SIDED|95.0|0.91|1.72||||||This analysis is for Black or African American participants||1.72|0.91|
71655779|NCT04280705|142829923|SUPERIORITY||Cox Proportional Hazard|1.29|||||TWO_SIDED|95.0|1.06|1.57||||||This analysis is for White participants||1.57|1.06|
71655780|NCT04280705|142829923|SUPERIORITY||Cox Proportional Hazard|1.68|||||TWO_SIDED|95.0|1.1|2.58||||||This analysis is for Race of Other participants||2.58|1.10|
71827001|NCT01768676|143158317|NON_INFERIORITY_OR_EQUIVALENCE|The difference in percentage of subjects with a \>/= 50% reduction from baseline to Week 26 in sperm concentration between treatment arms was analyzed using Cochran-Mantel-Haenszel method to account for the randomization stratification by baseline sperm concentration. If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-12.93|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-21.56|-4.29|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||-4.29|-21.56|
71827002|NCT01768676|143158318|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-11.4|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-23.5|0.7|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0.7|-23.5|
71827003|NCT01768676|143158319|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-1.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-4.2|1.3|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.3|-4.2|
71827004|NCT01768676|143158320|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-2.9|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-6.8|1.1|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||1.1|-6.8|
71655781|NCT04280705|142829924|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.1|1.55||||||This analysis is for Not Hispanic or Latino participants||1.55|1.10|
71655782|NCT04280705|142829924|SUPERIORITY||Cox Proportional Hazard|1.28|||||TWO_SIDED|95.0|0.94|1.73||||||This analysis is for Hispanic or Latino participants||1.73|0.94|
71655783|NCT04280705|142829925|SUPERIORITY||Cox Proportional Hazard|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||This analysis is for Male participants||1.56|1.09|
71655784|NCT04280705|142829925|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.03|1.66||||||This analysis is for Female participants||1.66|1.03|
71655785|NCT01196078|142829967|SUPERIORITY_OR_OTHER||Difference in Percentages|13.88||||0.0388|TWO_SIDED|95.0|-0.22|26.19||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group \[ECOG\] status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.|||26.19|-0.22|0.0388
71655786|NCT01196078|142829968|SUPERIORITY_OR_OTHER||Difference in Percentages|14.79||||0.1061|TWO_SIDED|95.0|-3.54|31.33||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.|||31.33|-3.54|0.1061
71655787|NCT01196078|142829969|SUPERIORITY_OR_OTHER|||||||0.9505|||||||Log Rank|||||||0.9505
71655788|NCT01196078|142829971|SUPERIORITY_OR_OTHER|||||||0.2314|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.2314
71655789|NCT01196078|142829973|SUPERIORITY_OR_OTHER|||||||0.9894|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.||||||0.9894
71655790|NCT01196078|142829975|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||PWB, Baseline versus Endpoint||||0.0060
71655791|NCT01196078|142829975|SUPERIORITY_OR_OTHER|||||||0.6871|||||||ANOVA|||SWB, Baseline versus Endpoint||||0.6871
71655792|NCT01196078|142829975|SUPERIORITY_OR_OTHER|||||||0.5104|||||||ANOVA|||EWB Baseline versus Endpoint||||0.5104
71655793|NCT01196078|142829975|SUPERIORITY_OR_OTHER|||||||0.9927|||||||ANOVA|||FWB, Baseline versus Endpoint||||0.9927
71655794|NCT01196078|142829975|SUPERIORITY_OR_OTHER|||||||0.3581|||||||ANOVA|||LCS, Baseline versus Endpoint||||0.3581
71655795|NCT02920918|142829994|SUPERIORITY|||||||0.083|||||||ANOVA|||We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).||||0.083
71655796|NCT02920918|142829995|SUPERIORITY|||||||0.51|||||||ANOVA|||||||0.51
71827005|NCT01768676|143158321|NON_INFERIORITY_OR_EQUIVALENCE|If upper limit of 95% CI \< 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|95.0|0.0|0.0|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.|||0|0|
71827006|NCT01875250|143158364|SUPERIORITY|||||||0.74|||||||Wilcoxon rank sum tests|||||||0.74
71886752|NCT00523991|143293821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.313||95.0|-5.45|1.75||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||1.75|-5.45|0.313
71655797|NCT03537274|142830010|SUPERIORITY|||||||0.078|||||||Chi-squared|||||||0.078
71655798|NCT03537274|142830010|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
71655799|NCT03537274|142830010|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71655800|NCT03537274|142830011|SUPERIORITY|||||||0.128|||||||Chi-squared|||||||0.128
71655801|NCT03537274|142830011|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71655802|NCT03537274|142830011|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71655803|NCT04688931|142830018|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.45|||||TWO_SIDED|95.0|0.29|0.68|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.68|0.29|
71655804|NCT04688931|142830019|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.3|0.7|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.70|0.30|
71655805|NCT04688931|142830021|OTHER|The analysis is descriptive in nature.|Cox Proportional Hazard|0.46|||||TWO_SIDED|95.0|0.24|0.86|||||The hazard ratio represents the relative risk of having an event in the treatment arm (numerator) versus the control arm (denominator).|||0.86|0.24|
71827007|NCT03068468|143158370|SUPERIORITY||Difference|-0.2||||0.8483|TWO_SIDED|95.0|-2.0|1.6|||Mixed model for repeated measures (MMRM)|||28-item:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on a mixed model for repeated measures model (MMRM), with change from baseline in 28-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment group-by-time interaction, baseline 28-item PSPRS, baseline 28-item PSPRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.6|-2.0|0.8483
71827008|NCT03068468|143158370|SUPERIORITY||Difference|-0.28||||0.6503|TWO_SIDED|95.0|-1.5|0.94|||MMRM|||15-items:Adjusted mean for each treatment group, difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in 15-item PSPRS total score as dependent variable and with fixed effects of treatment group, time(categorical), treatment groupby-time interaction, baseline 15-item PSPRS, baseline 15-item PSPRS by time interaction, baseline Color Trails 2 test(\<=170 or \>170 seconds) and region.||0.94|-1.50|0.6503
71827009|NCT03068468|143158372|SUPERIORITY||Difference|0.4||||0.6031|TWO_SIDED|95.0|-1.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MDS-UPDRS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline MDS-UPDRS, baseline MDS-UPDRS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|-1.0|0.6031
71827010|NCT03068468|143158373|SUPERIORITY||Difference|0.0||||0.7743|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with CGI-C as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.7743
71827011|NCT03068468|143158374|SUPERIORITY||Difference|0.038||||0.318|TWO_SIDED|95.0|-0.036|0.112|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-cognitive composite battery as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline PSP-cognitive composite battery, baseline PSP-cognitive composite battery by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.112|-0.036|0.3180
71827012|NCT03068468|143158375|SUPERIORITY||Difference|-0.2||||0.827|TWO_SIDED|95.0|-1.8|1.4|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in RBANS as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline RBANS , baseline RBANS by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds and region.||1.4|-1.8|0.8270
71827013|NCT03068468|143158376|SUPERIORITY||Difference|-0.2||||0.9304|TWO_SIDED|95.0|-3.6|3.3|||MMRM|||Physical scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSP-QoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.3|-3.6|0.9304
71827014|NCT03068468|143158376|SUPERIORITY||Difference|0.5||||0.7859|TWO_SIDED|95.0|-2.8|3.7|||MMRM|||Mental scale score: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||3.7|-2.8|0.7859
71827015|NCT03068468|143158376|SUPERIORITY||Difference|-1.7||||0.4297|TWO_SIDED|95.0|-5.8|2.5|||MMRM|||Satisfaction With Your Life Today: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in PSPQoL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-bytime interaction, baseline for PSP-QoL, baseline PSP-QoL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.5|-5.8|0.4297
71827016|NCT03068468|143158377|SUPERIORITY||Difference|2.0||||0.2084|TWO_SIDED|95.0|-1.1|5.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in SEADL as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for SEADL , baseline SEADL by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||5.2|-1.1|0.2084
71655806|NCT00450619|142830029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.041|TWO_SIDED|95.0|||||Log Rank|||||||0.041
71655807|NCT00450619|142830029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5019||||0.046|TWO_SIDED|95.0|||||Hazard Ratio|||||||0.046
71655808|NCT00450619|142830033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.3|TWO_SIDED|95.0|0.37|1.35|||Kaplan Meier|||||1.35|0.37|0.30
71655809|NCT02836496|142830066|SUPERIORITY|||||||0.002||||||Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region|Cochran-Mantel-Haenszel|||||||0.002
71655810|NCT02836496|142830066|SUPERIORITY||Odds Ratio (OR)|0.28||||0.003|TWO_SIDED|95.0|0.12|0.64|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region.|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.64|0.12|0.003
71655811|NCT02836496|142830067|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-\<=20 mg per day and \>20mg perday prednisone or equivalent) and region||||||0.020
71655812|NCT02836496|142830067|SUPERIORITY||Odds Ratio (OR)|0.33||||0.022|TWO_SIDED|95.0|0.13|0.85|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio \<1 indicated lower odds of HES flare with Mepolizumab compared with placebo.|||0.85|0.13|0.022
71655813|NCT02836496|142830068|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.002|TWO_SIDED|95.0|0.18|0.67||Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.|Regression, Cox||Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio \<1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.|||0.67|0.18|0.002
71711625|NCT00863304|142940289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.26||0.114|TWO_SIDED|95.0|-0.92|0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.10|-0.92|0.114
71711626|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.029|TWO_SIDED|95.0|-0.94|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.94|0.029
71711627|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.214|TWO_SIDED|95.0|-0.73|0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.16|-0.73|0.214
71711628|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.32|-1.21|<0.001
71711629|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.234|TWO_SIDED|95.0|-0.18|0.72||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.72|-0.18|0.234
71711630|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.23||0.034|TWO_SIDED|95.0|0.04|0.93||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.93|0.04|0.034
71711631|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.59|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.59|<0.001
71766076|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|74.23|STANDARD_ERROR_OF_MEAN|12.59|<|0.001|TWO_SIDED|90.0|53.38|95.07||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||95.07|53.38|<0.001
71766077|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|115.36|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|90.0|94.58|136.14||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||136.14|94.58|<0.001
71766078|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|135.57|STANDARD_ERROR_OF_MEAN|12.72|<|0.001|TWO_SIDED|90.0|114.5|156.63||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||156.63|114.50|<0.001
71766079|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.47|STANDARD_ERROR_OF_MEAN|4.85||0.002|TWO_SIDED|90.0|-23.5|-7.43||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-7.43|-23.50|0.002
71655814|NCT02836496|142830069|SUPERIORITY||Rate Ratio|0.34||||0.002|TWO_SIDED|95.0|0.19|0.63|||Wilcoxon Rank Sum Test|Wilcoxon test stratified by Baseline OCS (0-\<=20 mg/day, \>20 mg/day prednisone or equivalent) and region.|Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio \<1 indicates a lower flare rate with Mepolizumab compared with Placebo.|||0.63|0.19|0.002
71655815|NCT02836496|142830070|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank Sum Test|P-value was calculated using Wilcoxon Rank Sum Test||||||0.036
71655816|NCT00354341|142830071|SUPERIORITY_OR_OTHER|||||||0.8811|TWO_SIDED|||||P-value was calculated by ANCOVA with last observation carry forward (LOCF) method.|ANCOVA with LOCF|||||||0.8811
71655817|NCT00354341|142830072|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED||||||ANCOVA with LOCF|||||||0.8864
71655818|NCT00354341|142830073|SUPERIORITY_OR_OTHER|||||||0.5681|TWO_SIDED||||||ANCOVA with LOCF|||||||0.5681
71655819|NCT00354341|142830074|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA with LOCF|||||||0.1578
71655820|NCT00354341|142830075|SUPERIORITY_OR_OTHER|||||||0.2913|TWO_SIDED||||||ANCOVA with LOCF|||||||0.2913
71655821|NCT00354341|142830076|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71655822|NCT03822832|142830077|OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|17.4||0.1492|TWO_SIDED|90.0|-54.9|3.7|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||3.7|-54.9|0.1492
71655823|NCT03822832|142830079|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.8613|TWO_SIDED|90.0|-5.7|7.0|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||7.0|-5.7|0.8613
71655824|NCT03822832|142830080|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|14.0||0.8754|TWO_SIDED|90.0|-25.8|21.4|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||21.4|-25.8|0.8754
71711632|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.37|-0.45||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.45|-1.37|<0.001
71711633|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.24||0.012|TWO_SIDED|95.0|-1.05|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-1.05|0.012
71766080|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.37|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|90.0|-31.37|-15.38||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-15.38|-31.37|<0.001
71766081|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.19|STANDARD_ERROR_OF_MEAN|4.91|<|0.001|TWO_SIDED|90.0|-30.32|-14.06||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.||-14.06|-30.32|<0.001
71766082|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|103.25|STANDARD_ERROR_OF_MEAN|12.64|<|0.001|TWO_SIDED|90.0|82.32|124.18||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||124.18|82.32|<0.001
71766083|NCT01375075|143034040|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.63|STANDARD_ERROR_OF_MEAN|4.88||0.003|TWO_SIDED|90.0|-22.72|-6.55||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||||-6.55|-22.72|0.003
71766084|NCT03137069|143034066|SUPERIORITY||Least Squares Mean Difference|-7.02||||0.0559|TWO_SIDED|90.0|-13.01|-1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-1.03|-13.01|0.0559
71766085|NCT03137069|143034066|SUPERIORITY||Least Squares Mean Difference|-0.51||||0.8892|TWO_SIDED|90.0|-6.6|5.58|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||5.58|-6.60|0.8892
71766086|NCT03137069|143034066|SUPERIORITY||Least Squares Mean Difference|-6.43||||0.0717|TWO_SIDED|90.0|-12.29|-0.57|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-0.57|-12.29|0.0717
71766087|NCT03137069|143034066|SUPERIORITY||Least Squares Mean Difference|-9.53||||0.0097|TWO_SIDED|90.0|-15.5|-3.55|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-3.55|-15.50|0.0097
71711634|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.0|-0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.07|-1.00|0.023
71766088|NCT03137069|143034067|SUPERIORITY|||||||0.1087|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.1087
71766089|NCT03137069|143034067|SUPERIORITY|||||||0.3418|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.3418
71766090|NCT03137069|143034067|SUPERIORITY|||||||0.0459|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0459
71766091|NCT03137069|143034067|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Stratified by region||||||0.0190
71886753|NCT00523991|143293822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.682||95.0|-4.6|3.01||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||3.01|-4.60|0.682
71886754|NCT00523991|143293823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76||||0.043||95.0|-7.39|-0.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||-0.13|-7.39|0.043
71766092|NCT03137069|143034068|SUPERIORITY||Least Squares Mean Difference|-12.88||||0.001|TWO_SIDED|90.0|-18.94|-6.82|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-6.82|-18.94|0.0010
71766093|NCT03137069|143034068|SUPERIORITY||Least Squares Mean Difference|-2.83||||0.4565|TWO_SIDED|90.0|-9.11|3.46|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||3.46|-9.11|0.4565
71766094|NCT03137069|143034068|SUPERIORITY||Least Squares Mean Difference|-5.03||||0.1711|TWO_SIDED|90.0|-11.1|1.03|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||1.03|-11.10|0.1711
71766095|NCT03137069|143034068|SUPERIORITY||Least Squares Mean Difference|-10.76||||0.005|TWO_SIDED|90.0|-16.97|-4.56|||Mixed Models Analysis|Covariates included were region, treatment group, visit, and visit by treatment group interaction||||-4.56|-16.97|0.0050
71775049|NCT01086423|143050303|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.68|||||TWO_SIDED|95.0|-1.88|3.76||||||To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.||3.76|-1.88|
71827017|NCT03068468|143158378|SUPERIORITY||Difference|0.0||||0.5701|TWO_SIDED|95.0|-0.2|0.1|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CGI-S as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for CGI-S, baseline CGI-S by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.1|-0.2|0.5701
71827018|NCT03068468|143158379|SUPERIORITY||Difference|0.9||||0.0517|TWO_SIDED|95.0|0.0|1.8|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Phonemic Fluency Test as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Phonemic Fluency Test, baseline Phonemic Fluency Test by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.8|-0.0|0.0517
71827019|NCT03068468|143158380|SUPERIORITY||Difference|0.9||||0.0387|TWO_SIDED|95.0|0.0|1.7|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Letter Number Sequence as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline Letter Number Sequence, baseline Letter Number Sequence by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.7|0.0|0.0387
71827020|NCT03068468|143158381|SUPERIORITY||Difference|0.1||||0.9815|TWO_SIDED|95.0|-8.1|8.3|||MMRM|||Color Trails Test 1: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color trails Test 1 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 1, baseline Color Trails Test 1 by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||8.3|-8.1|0.9815
71827021|NCT03068468|143158381|SUPERIORITY||Difference|0.0||||0.9869|TWO_SIDED|95.0|-5.7|5.6|||MMRM|||Color Trails Test 2: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in Color Trails Test 2 as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for Color Trails Test 2, baseline Color Trails Test 2 by time interaction, and region.||5.6|-5.7|0.9869
71827022|NCT03068468|143158382|SUPERIORITY||Difference|0.5||||0.1763|TWO_SIDED|95.0|-0.2|1.2|||MMRM|||Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MoCA as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MoCA, baseline MoCA by time interaction,baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||1.2|-0.2|0.1763
71827023|NCT03068468|143158384|SUPERIORITY||Difference|-0.021||||0.9527|TWO_SIDED|95.0|-0.726|0.684|||MMRM|||Ventricles Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.684|-0.726|0.9527
71827024|NCT03068468|143158384|SUPERIORITY||Difference|-0.514||||0.7357|TWO_SIDED|95.0|-3.506|2.478|||MMRM|||Whole Brain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||2.478|-3.506|0.7357
71827025|NCT03068468|143158384|SUPERIORITY||Difference|-0.004||||0.6439|TWO_SIDED|95.0|-0.023|0.014|||MMRM|||Midbrain Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.014|-0.023|0.6439
71827026|NCT03068468|143158384|SUPERIORITY||Difference|0.0||||0.9864|TWO_SIDED|95.0|-0.039|0.04|||MMRM|||Pons Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.040|-0.039|0.9864
71655825|NCT03822832|142830081|OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|90.0|-0.254|0.176||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.176|-0.254|
71655826|NCT03822832|142830081|OTHER||Risk Difference (RD)|0.247|||||TWO_SIDED|90.0|0.053|0.396||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.396|0.053|
71655827|NCT03822832|142830082|OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.204|0.117||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.117|-0.204|
71655828|NCT03822832|142830082|OTHER||Risk Difference (RD)|0.096|||||TWO_SIDED|90.0|-0.08|0.232||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Pl|Risk difference at week 16||0.232|-0.080|
71655829|NCT03822832|142830083|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.7||0.99|TWO_SIDED|90.0|-14.6|14.8|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||14.8|-14.6|0.9900
71655830|NCT03822832|142830084|OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|12.1||0.2266|TWO_SIDED|90.0|-35.2|5.5|||Mixed Models Analysis|See endpoint description for model description.|Difference calculated as Spesolimab - Placebo.|||5.5|-35.2|0.2266
71886755|NCT00523991|143293825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.823||95.0|-6.01|4.79||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.79|-6.01|0.823
71655831|NCT03822832|142830085|OTHER||Risk Difference (RD)|0.005|||||TWO_SIDED|90.0|-0.159|0.12||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 4||0.120|-0.159|
71655832|NCT03822832|142830085|OTHER||Risk Difference (RD)|0.091|||||TWO_SIDED|90.0|-0.05|0.207||||CIs are calculated using the method of Wilson and Newcombe.|Difference calculated as Spesolimab - Placebo|Risk difference at week 16||0.207|-0.050|
71655833|NCT02737332|142830106|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio of treatments|1.019||||0.4879|TWO_SIDED|90.0|0.964|1.077||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.077|0.964|0.4879
71655834|NCT02737332|142830107|OTHER|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.994||||0.3642|TWO_SIDED|90.0|0.0451|2.192||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.192|0.0451|0.3642
71655835|NCT02737332|142830107|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.81||||0.4069|TWO_SIDED|90.0|0.338|1.939||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.939|0.338|0.4069
71655836|NCT02737332|142830107|EQUIVALENCE|One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|Geometric mean ratio|1.039||||0.7186|TWO_SIDED|90.0|0.412|2.617||The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||2.617|0.412|0.7186
71655837|NCT02737332|142830108|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71655838|NCT02737332|142830109|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|0.999||||0.9211|TWO_SIDED|90.0|0.98|1.018||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.||ANOVA-model-based Least-Square Mean|1.018|0.980|0.9211
71655839|NCT02737332|142830109|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.168||||0.3037|TWO_SIDED|90.0|0.9|1.515||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.515|0.900|0.3037
71655840|NCT02737332|142830109|EQUIVALENCE|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.0||One-way ANOVA model with treatment as the independent variable, and the least-square means and standard error of Testosterone levels under each treatment and the between-treatment difference in LS means was reported.|ANOVA||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|||1.000|1.000|
71655841|NCT02737332|142830110|OTHER|||||||0.5495|||||||ANOVA|||||||0.5495
71655842|NCT02737332|142830110|OTHER|||||||0.2616|||||||ANOVA|||||||0.2616
71655843|NCT02737332|142830110|OTHER|||||||0.3632|||||||ANOVA|||||||0.3632
71655844|NCT02737332|142830110|OTHER|||||||0.3393|||||||ANOVA|||||||0.3393
71655845|NCT02737332|142830114|OTHER|||||||0.1917|||||||ANOVA|||||||0.1917
71655846|NCT00557076|142830115|NON_INFERIORITY_OR_EQUIVALENCE|Because 50% of the planned sample size was randomized, achieved power for the DOCS is 0.51.|Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|7.0||0.465|TWO_SIDED|95.0|-11.1|21.9|||t-test, 1 sided|DOCS scores were transformed to interval level measures using a many-faceted Rasch model anchored to values from a larger validation data set|The mean difference between the baseline and endpoint DOCS test was compared between the FAST and Sham groups.|The planned sample of 15 per group provided 80% power for a one-sided t-test to detect be-tween group endpoint differences in DOCS averages equivalent to an effect size of .91 (9 units). Clinically, this assumes that the FAST protocol would facilitate progression from one clinical state to another (e.g., vegetative (VS) to minimally conscious (MCS) states). The hypothesized effect was based on average DOCS change for a severe TBI sample receiving three weeks of acute rehabilitation.||21.9|-11.1|.465
71775050|NCT01086423|143050303|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.56|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.||2.56|-2.56|
71655847|NCT00557076|142830116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.346||0.049|TWO_SIDED|95.0|-1.51|-0.00493|||t-test, 1 sided|CNC scores were transformed to interval level measures using Rasch partial credit and Facets models. We then re-scaled these logits to 0-100 scales.|The mean difference was calculated for each group using the eighth CNC measure minus the Baseline CNC measure.|Power was not calculated for the CNC because the effect size was not published.||-.00493|-1.51|0.049
71655848|NCT00557076|142830116|SUPERIORITY_OR_OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0022|TWO_SIDED|||||To confirm that CNC results were not an anomaly at the final measurement and that the overall CNC response pattern was consistent, mixed-effect longitudinal models were conducted.|t-test, 1 sided||The Baseline CNC measure and seven post-Baseline CNC measures (for a total of eight CNC measures) were used to calculate the slope.|||||.0022
71655849|NCT00688376|142830117|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8||||0.694|TWO_SIDED|95.0|-3.22|4.8|||ANCOVA|||P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.||4.8|-3.22|0.694
71655850|NCT00688376|142830118|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.9458|TWO_SIDED|95.0|-4.38|4.09|||ANCOVA|||P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.09|-4.38|0.9458
71655851|NCT00688376|142830119|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4||||0.743|TWO_SIDED|95.0|-9.56|6.85|||ANCOVA|||RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6.85|-9.56|0.743
71655852|NCT00688376|142830119|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.9561|TWO_SIDED|95.0|-7.42|7.84|||ANCOVA|||RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||7.84|-7.42|0.9561
71655853|NCT00688376|142830119|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.5||||0.4385|TWO_SIDED|95.0|-3.97|9.04|||ANCOVA|||RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||9.04|-3.97|0.4385
71655854|NCT00688376|142830119|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.9088|TWO_SIDED|95.0|-6.74|6.0|||ANCOVA|||RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||6|-6.74|0.9088
71655855|NCT00688376|142830120|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.2886|TWO_SIDED|95.0|-1.5|4.96|||ANCOVA|||Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.96|-1.5|0.2886
71655856|NCT00688376|142830120|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.1||||0.2555|TWO_SIDED|95.0|-1.54|5.69|||ANCOVA|||Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||5.69|-1.54|0.2555
71655857|NCT00688376|142830120|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.7||||0.3155|TWO_SIDED|95.0|-1.63|4.99|||ANCOVA|||Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||4.99|-1.63|0.3155
71655858|NCT00688376|142830120|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.9075|TWO_SIDED|95.0|-3.55|3.16|||ANCOVA|||Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.||3.16|-3.55|0.9075
71655859|NCT02666352|142830139|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
71655860|NCT02666352|142830139|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
71655861|NCT02666352|142830140|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.88|2.31||||||||2.31|0.88|
71655862|NCT02666352|142830140|OTHER||Geometric least-squares mean ratio|2.15||||||90.0|1.33|3.48||||||||3.48|1.33|
71655863|NCT02666352|142830141|OTHER||Geometric least-squares mean ratio|1.43|||||TWO_SIDED|90.0|0.89|2.31||||||||2.31|0.89|
71655864|NCT02666352|142830141|OTHER||Geometric least-squares mean ratio|2.15|||||TWO_SIDED|90.0|1.33|3.47||||||||3.47|1.33|
71655865|NCT02666352|142830142|OTHER||Geometric least-squares mean ratio|1.32|||||TWO_SIDED|90.0|0.81|2.15||||||||2.15|0.81|
71655866|NCT02666352|142830142|OTHER||Geometric least-squares mean ratio|1.81|||||TWO_SIDED|90.0|1.11|2.94||||||||2.94|1.11|
71655867|NCT02666352|142830148|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.1||||||||1.10|0.58|
71655868|NCT02666352|142830148|OTHER||Geometric least-squares mean ratio|0.84|||||TWO_SIDED|90.0|0.61|1.16||||||||1.16|0.61|
71655869|NCT02666352|142830149|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.58|1.11||||||||1.11|0.58|
71655870|NCT02666352|142830149|OTHER||Geometric least-squares mean ratio|0.86||||||90.0|0.62|1.18||||||||1.18|0.62|
71655871|NCT02666352|142830150|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.57|1.05||||||||1.05|0.57|
71655872|NCT02666352|142830150|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.54|0.99||||||||0.99|0.54|
71655873|NCT02666352|142830151|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.13||||||||1.13|0.61|
71655874|NCT02666352|142830151|OTHER||Geometric least-squares mean ratio|0.75|||||TWO_SIDED|90.0|0.55|1.01||||||||1.01|0.55|
71655875|NCT02666352|142830152|OTHER||Geometric least-squares mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||||1.15|0.60|
71655876|NCT02666352|142830152|OTHER||Geometric least-squares mean ratio|0.82|||||TWO_SIDED|90.0|0.59|1.13||||||||1.13|0.59|
71655877|NCT02666352|142830156|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.52|0.9||||||||0.90|0.52|
71711635|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.175|TWO_SIDED|95.0|-0.78|0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.14|-0.78|0.175
71711636|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.55|<0.001
71711637|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.41||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.41|-1.34|<0.001
71711638|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.03|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-1.03|0.017
71827027|NCT03068468|143158384|SUPERIORITY||Difference|0.001||||0.7529|TWO_SIDED|95.0|-0.004|0.006|||MMRM|||Cerebellar Peduncle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.006|-0.004|0.7529
71827028|NCT03068468|143158384|SUPERIORITY||Difference|0.006||||0.685|TWO_SIDED|95.0|-0.025|0.038|||MMRM|||Third Ventricle Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.038|-0.025|0.6850
71827029|NCT03068468|143158384|SUPERIORITY||Difference|-0.041||||0.9|TWO_SIDED|95.0|-0.68|0.598|||MMRM|||Frontal Lobe Volume: Adjusted mean for each treatment group, difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MRI region as dependent variable and with fixed effects of treatment group, time (categorical), treatment group-by-time interaction, baseline for MRI region, baseline MRI region by time interaction, baseline Color Trails 2 test (\<=170 or \>170 seconds) and region.||0.598|-0.680|0.9000
71827030|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.235|TWO_SIDED|95.0|0.45|1.22|||Univariate logistic regression model|||Comparison between genders: women and men.||1.22|0.45|0.235
71827031|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.331|TWO_SIDED|95.0|0.55|1.22|||Univariate logistic regression model|||Comparison between Age: \<= 55 years and \> 55 years||1.22|0.55|0.331
71827032|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.05|TWO_SIDED|95.0|1.0|2.23|||Univariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.23|1.00|0.050
71827033|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.144|TWO_SIDED|95.0|0.88|2.46|||Univariate logistic regression model|||Comparison between participants without erosive rheumatoid arthritis (RA) and participants with erosive RA||2.46|0.88|0.144
71827034|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.65|||Univariate logistic regression model|||Comparison between DAS-28 score: \<= 5.1 and DAS-28 \>5.1||2.65|1.14|0.010
71827035|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.119|TWO_SIDED|95.0|0.92|2.1|||Univariate logistic regression model|||Comparison between ESR: \<= 28 mm/h and \> 28 mm/h||2.10|0.92|0.119
71827036|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.265|TWO_SIDED|95.0|0.81|2.13|||Univariate logistic regression model|||Comparison between number of participants without anemia and number of participants with anemia||2.13|0.81|0.265
71827037|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.511|TWO_SIDED|95.0|0.77|1.71|||Univariate logistic regression model|||Comparison between dose of corticosteroids: \<= 5 mg and \> 5 mg||1.71|0.77|0.511
71827038|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.153|TWO_SIDED|95.0|0.9|2.0|||Univariate logistic regression model|||Comparison between HAQ score: \<= 1.5 and \> 1.5||2.00|0.90|0.153
71827039|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.001|TWO_SIDED|95.0|1.45|3.31|||Univariate logistic regression model|||Comparison between VAS patient: fatigue \<= 66 and \> 66||3.31|1.45|<0.001
71711639|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.027|TWO_SIDED|95.0|-0.99|-0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.06|-0.99|0.027
71827040|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.001|TWO_SIDED|95.0|1.35|3.08|||Univariate logistic regression model|||Comparison between VAS patient: pain \<= 66 and \> 66||3.08|1.35|<0.001
71711640|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.24||0.19|TWO_SIDED|95.0|-0.78|0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.15|-0.78|0.190
71827041|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.261|TWO_SIDED|95.0|0.86|2.75|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<=30 score and 30 - 59 score||2.75|0.86|0.261
71827042|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.261|TWO_SIDED|95.0|0.67|2.05|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and 59 - 77||2.05|0.67|0.261
71827043|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.261|TWO_SIDED|95.0|0.95|2.89|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: \<= 30 and \> 77||2.89|0.95|0.261
71827044|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.001|TWO_SIDED|95.0|1.38|3.14|||Univariate logistic regression model|||Comparison between VAS patient: global assessment score: \<= 67 and \> 67||3.14|1.38|<0.001
71827045|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.5|3.47|||Univariate logistic regression model|||Comparison between SF36 vitality score: \> 33 and \<= 33||3.47|1.50|< 0.001
71827046|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.399|TWO_SIDED|95.0|0.6|1.93|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Doubtful case)||1.93|0.60|0.399
71827047|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.399|TWO_SIDED|95.0|0.48|1.26|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Certain case)||1.26|0.48|0.399
71827048|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.858|TWO_SIDED|95.0|0.65|1.81|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Doubtful case)||1.81|0.65|0.858
71827049|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.858|TWO_SIDED|95.0|0.57|1.52|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Certain case)||1.52|0.57|0.858
71827050|NCT01185522|143158395|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.036|TWO_SIDED|95.0|1.03|2.58|||Multivariate logistic regression model|||Comparison between time since initial diagnosis: \>= 10 years and \< 10 years||2.58|1.03|0.036
71827051|NCT01185522|143158396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Univariate logistic regression model|||Predictive factor: C-Reactive Protein||1.28|1.05|0.004
71827052|NCT01185522|143158396|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.013|TWO_SIDED|95.0|1.03|1.27|||Multivariate logistic regression model|||Predictive factor: C-Reactive Protein||1.27|1.03|0.013
71827053|NCT01185522|143158397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.253|TWO_SIDED|95.0|0.99|1.05|||Univariate logistic regression model|||Predictive factor: Tender joint||1.05|0.99|0.253
71827054|NCT01185522|143158397|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.021|TWO_SIDED|95.0|1.01|1.09|||Univariate logistic regression model|||Predictive factor : Swollen joint||1.09|1.01|0.021
71827055|NCT00309452|143158438|SUPERIORITY_OR_OTHER|||||||0.018|||||||Chi-squared, Corrected|||Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization||||0.018
71827056|NCT00309452|143158442|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement||||0.002
71827057|NCT00771667|143158449|SUPERIORITY_OR_OTHER|||||||0.005||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.005
71827058|NCT00771667|143158449|SUPERIORITY_OR_OTHER|||||||0.057||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.057
71655878|NCT02666352|142830156|OTHER||Geometric least-squares mean ratio|0.66|||||TWO_SIDED|90.0|0.5|0.86||||||||0.86|0.50|
71655879|NCT02666352|142830157|OTHER||Geometric least-squares mean ratio|0.64|||||TWO_SIDED|90.0|0.48|0.86||||||||0.86|0.48|
71655880|NCT02666352|142830157|OTHER||Geometric least-squares mean ratio|0.61||||||90.0|0.46|0.82||||||||0.82|0.46|
71655881|NCT02666352|142830158|OTHER||Geometric least-squares mean ratio|0.79|||||TWO_SIDED|90.0|0.62|1.01||||||||1.01|0.62|
71827059|NCT00771667|143158449|SUPERIORITY_OR_OTHER|||||||0.021||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.021
71827060|NCT00771667|143158450|SUPERIORITY_OR_OTHER|||||||0.682|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.682
71827061|NCT00771667|143158450|SUPERIORITY_OR_OTHER|||||||0.206|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.206
71827062|NCT00771667|143158450|SUPERIORITY_OR_OTHER|||||||0.196|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.196
71827063|NCT00771667|143158451|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.008
71827064|NCT00771667|143158451|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
71827065|NCT00771667|143158451|SUPERIORITY_OR_OTHER|||||||0.035|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.035
71827066|NCT00771667|143158452|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||<0.001
71827067|NCT00771667|143158452|SUPERIORITY_OR_OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.007
71827068|NCT00771667|143158452|SUPERIORITY_OR_OTHER|||||||0.006|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.006
71827069|NCT00771667|143158453|SUPERIORITY_OR_OTHER|||||||0.074|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.074
71827070|NCT00771667|143158453|SUPERIORITY_OR_OTHER|||||||0.081|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.081
71827071|NCT00771667|143158453|SUPERIORITY_OR_OTHER|||||||0.105|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.||||||0.105
71827072|NCT00771667|143158454|SUPERIORITY_OR_OTHER|||||||0.029||||||Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.|Cochran-Mantel-Haenszel|The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.||||||0.029
71655882|NCT02666352|142830158|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.63|1.02||||||||1.02|0.63|
71655883|NCT02666352|142830159|OTHER||Geometric least-squares mean ratio|0.8|||||TWO_SIDED|90.0|0.61|1.05||||||||1.05|0.61|
71655884|NCT02666352|142830159|OTHER||Geometric least-squares mean ratio|0.78|||||TWO_SIDED|90.0|0.6|1.03||||||||1.03|0.60|
71655885|NCT02666352|142830160|OTHER||Geometric least-squares mean ratio|0.71|||||TWO_SIDED|90.0|0.57|0.89||||||||0.89|0.57|
71655886|NCT02666352|142830160|OTHER||Geometric least-squares mean ratio|0.73|||||TWO_SIDED|90.0|0.58|0.91||||||||0.91|0.58|
71827073|NCT00771667|143158455|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for induction dose and clinical remission status at Week 6.||||||<0.001
71827074|NCT01803646|143158523|SUPERIORITY||Mean Difference (Net)|-0.17||||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||||0.17|-0.51|0.32
71827075|NCT01803646|143158524|SUPERIORITY||Mean Difference (Net)|-0.79||||0.63|TWO_SIDED|95.0|-4.0|2.4|||Mixed Models Analysis|||||2.4|-4|0.63
71827076|NCT01803646|143158525|SUPERIORITY|||||||0.821|||||||Fisher Exact|||Analysis for air conduction||||0.821
71827077|NCT01803646|143158525|SUPERIORITY|||||||1|||||||Fisher Exact|||Analysis for bone conduction||||1.0
71827078|NCT02281318|143158528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||<|0.001|TWO_SIDED|95.0|-10.5|-4.9|||Mixed model repeated measures analysis|||||-4.9|-10.5|<0.001
71827079|NCT02281318|143158529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0||||0.001|TWO_SIDED|95.0|47.0|192.0|||Mixed model repeated measures analysis|||||192|47|0.001
71827080|NCT02281318|143158530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.55|3.22|||Regression, Logistic|||||3.22|1.55|<0.001
71827081|NCT02281318|143158531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||Mixed model repeated measures analysis|||||-0.22|-0.58|<0.001
71827082|NCT00812877|143158532|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.35||||0.046|TWO_SIDED|95.0|1.19|4.66||A clustered permutation test with 10,000 random permutations based on the log rank test statistic was used for the primary treatment comparison to account for censoring and to ensure proper test size given the number of practices.|Log Rank||A confirmatory analysis, adjusted for patient, dentist, and tooth characteristics, and follow-up time, was performed using marginal proportional hazards regression with robust standard error estimates accounting for clustering by practice.|||4.66|1.19|.046
71827083|NCT01368406|143158593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.055|TWO_SIDED|95.0|-0.65|1.13|||t-test, 2 sided|t test for independent samples||||1.13|-0.65|0.055
71827084|NCT01368406|143158593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.055|TWO_SIDED|95.0|0.13|0.83|||t-test, 2 sided|||||0.83|0.13|0.055
71827085|NCT02228408|143158597|SUPERIORITY|||||||0.04|||||||poisson|||||||0.04
71827086|NCT02228408|143158598|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
71827087|NCT02228408|143158599|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
71827088|NCT02228408|143158603|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
71827089|NCT03670602|143158619|SUPERIORITY|||||||0.0035||||||This is for the treatment group x time effect, or if treatment influenced improvements in delay discounting across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate.||||0.0035
71827090|NCT03670602|143158619|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if delay discounting improved across all three timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Treatment group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
71827091|NCT03670602|143158620|SUPERIORITY|||||||0.85||||||This is for the treatment group x time effect, or if treatment differentially influenced weight across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.85
71827092|NCT03670602|143158620|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if time influenced changes in weight, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
71827093|NCT03670602|143158621|SUPERIORITY|||||||0.79||||||This is for the treatment group x time effect, or if treatment group influenced change in hBa1c across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.79
71655887|NCT02666352|142830163|OTHER||Geometric least-squares mean ratio (GMR)|1.16|||||TWO_SIDED|90.0|0.85|1.58||||||||1.58|0.85|
71655888|NCT02666352|142830163|OTHER||Geometric least-squares mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.85||||||||1.85|1.00|
71655889|NCT02666352|142830164|OTHER||Geometric least-squares mean ratio|1.24|||||TWO_SIDED|90.0|0.91|1.68||||||||1.68|0.91|
71827094|NCT03670602|143158621|SUPERIORITY||||||<|0.001||||||This is for the time effect, or if hBa1c changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.001
71827095|NCT03670602|143158622|SUPERIORITY|||||||0.201||||||This is for the treatment group x time effect, or if treatment differentially influenced medication adherence across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.201
71886756|NCT00523991|143293826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.767||95.0|-7.86|5.81||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.81|-7.86|0.767
71827096|NCT03670602|143158622|SUPERIORITY|||||||0.315||||||This is for the time effect, or if timepoint influenced medication adherence across all timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.315
71655890|NCT02666352|142830164|OTHER||Geometric least-squares mean ratio|1.58||||||90.0|1.17|2.14||||||||2.14|1.17|
71655891|NCT02666352|142830165|OTHER||Geometric least-squares mean ratio|0.89|||||TWO_SIDED|90.0|0.6|1.33||||||||1.33|0.60|
71655892|NCT02666352|142830165|OTHER||Geometric least-squares mean ratio|0.9|||||TWO_SIDED|90.0|0.6|1.34||||||||1.34|0.60|
71655893|NCT02666352|142830166|OTHER||Geometric least-squares mean ratio|0.77|||||TWO_SIDED|90.0|0.45|1.3||||||||1.30|0.45|
71655894|NCT02666352|142830166|OTHER||Geometric least-squares mean ratio|0.68|||||TWO_SIDED|90.0|0.4|1.14||||||||1.14|0.40|
71655895|NCT02666352|142830167|OTHER||Geometric least-squares mean ratio|1.2|||||TWO_SIDED|90.0|0.9|1.6||||||||1.60|0.90|
71655896|NCT02666352|142830167|OTHER||Geometric least-squares mean ratio|1.41|||||TWO_SIDED|90.0|1.06|1.87||||||||1.87|1.06|
71655897|NCT03979820|142830180|OTHER||Ratio of geometric mean TSFs|544.36|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|340.57|870.09|||ANOVA||"The arm Phenelzine/Phenelzine + Tyramine represented the numerator. The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||870.09|340.57|
71655898|NCT03979820|142830180|OTHER||Ratio of geometric mean TSFs|123.22|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|77.09|196.95|||ANOVA||"The arm 10 mg BI 1467335/10 mg BI 1467335 + Tyramine represented the numerator.~The arm Placebo/Placebo + Tyramine represented the denominator."|"The statistical model used for the analysis of the primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale for each treatment relative to placebo.~TSF was log-transformed (natural logarithm) prior to fitting the ANOVA model. The model included the fixed effects 'treatment'."||196.95|77.09|
71655899|NCT01640873|142830211|OTHER||Least Squares Mean Difference|-8.5||||0.356|TWO_SIDED|90.0|-47.4|30.4||The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met.|Constrained longitudinal data analysis|||||30.4|-47.4|0.356
71655900|NCT01640873|142830213|OTHER||Geometric Mean Ratio|1.05||||0.2714|TWO_SIDED|90.0|0.92|1.19||The posterior probability that the reduction in 24h-WMG is ≥ 20 mg/dL is \< 0.01, and hence, the 24h- WMG hypothesis was not met.|Constrained longitudinal data analysis|||||1.19|0.92|0.2714
71655901|NCT01640873|142830214|OTHER|Day 1|Geometric Mean Ratio|1.22||||0.06|TWO_SIDED|95.0|0.99|1.55|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.55|0.99|0.060
71655902|NCT01640873|142830214|OTHER|Day 3|Geometric mean Ratio|1.2||||0.065|TWO_SIDED|95.0|0.98|1.47|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.47|0.98|0.065
71655903|NCT01640873|142830214|OTHER|Day 16|Geometric Mean Ratio|1.1||||0.217|TWO_SIDED|95.0|0.89|1.37|||ANOVA|Placebo-corrected (MK-8655 / placebo)||||1.37|0.89|0.217
71655904|NCT04764630|142830219|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.95||||0.002|ONE_SIDED|95.6|1.28|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 10-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (10, 12.5, and 15 min). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (1 every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.28|0.002
71711641|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.63|-0.68||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.68|-1.63|<0.001
71711642|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.55|-0.6||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.60|-1.55|<0.001
71711643|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.24||0.034|TWO_SIDED|95.0|-0.99|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.99|0.034
71711644|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|9.0|-1.12|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.12|0.009
71711645|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.023|TWO_SIDED|95.0|-1.04|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-1.04|0.023
71711646|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.64||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.64|-1.60|<0.001
71827097|NCT03670602|143158623|SUPERIORITY|A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||||0.345||||||This is for the treatment group x time effect, or if treatment group influenced change in percent of time engaged in moderate-to-vigorous physical activity (MVPA) across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||||||0.345
71711647|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.35|<0.001
71886757|NCT00523991|143293827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.754||95.0|-4.12|5.67||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.67|-4.12|0.754
71711648|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.25||0.092|TWO_SIDED|95.0|-0.9|0.07||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.07|-0.90|0.092
71711649|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.19|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.19|0.004
71711650|NCT00863304|142940290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.25||0.064|TWO_SIDED|95.0|-0.94|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.94|0.064
71711651|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
71711652|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
71711653|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
71711654|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
71711655|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
71711656|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.74|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.74|<0.001
71711657|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.58|-0.66||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.66|-1.58|<0.001
71711658|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.19|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.19|0.002
71711659|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.019|TWO_SIDED|95.0|-1.01|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-1.01|0.019
71711660|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
71711661|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.7|-0.78||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.78|-1.70|<0.001
71711662|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.47|-0.54||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.54|-1.47|<0.001
71886758|NCT00523991|143293828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.995||95.0|-6.31|6.27||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.27|-6.31|0.995
71886759|NCT00523991|143293829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.72||95.0|-7.77|5.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||5.39|-7.77|0.720
71711663|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.009
71711664|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.08|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.08|0.008
71711665|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.101|TWO_SIDED|95.0|-0.85|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.85|0.101
71711666|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.83||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.83|-1.79|<0.001
71711667|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.63|-0.67||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.67|-1.63|<0.001
71711668|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.21|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.21|0.003
71711669|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.08|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.08|0.016
71711670|NCT00863304|142940291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.25||0.082|TWO_SIDED|95.0|-0.91|0.06||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.06|-0.91|0.082
71711671|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.001|TWO_SIDED|95.0|-1.12|-0.27||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.27|-1.12|0.001
71711672|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.22||0.003|TWO_SIDED|95.0|-1.09|-0.23||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.23|-1.09|0.003
71766096|NCT02043899|143034080|OTHER|"1. Exact one-sided binomial test of the null hypothesis (p≤90%) using α=0.05 on \[124I\]mIBG PET/CT SIOPEN consensus scores. If this was accepted and the alternative hypothesis rejected, then trial stopped early for futility.~2. If the null hypothesis was rejected, then a one-sided binomial test of the null hypothesis (p≥97%) was performed (α=0.025). If this was accepted and the alternative hypothesis rejected then the trial stopped early for efficacy."|||||<|0.001||||||Overall design has 82% power and an α of 0.03. Total minimum sample size of 100 lesions was calculated based on a single stage A'hern design with p0 = 0.90 and p1 = 0.97. The overall power and α was calculated based on exact binomial probabilities.|Exact one-sided binomial test||||"For the primary endpoint, a sensitivity analysis was also performed on patients with \<20 positive lesions on \[124I\]mIBG PET/CT to test if few patients with large numbers of positive lesions were affecting the results. The results of the sensitivity analysis were consistent with those of the overall analysis.~Secondary efficacy analysis, separate exact one-sided binomial test of the null hypothesis (p≥97%), performed (α=0.025) performed for skeletal and soft tissue lesions."|||<0.001
71766097|NCT02720107|143034083|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Naïve T cells||||< 0.0001
71766098|NCT02720107|143034083|SUPERIORITY_OR_OTHER|||||||0.0493||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Central memory T cells||||0.0493
71766099|NCT02720107|143034083|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Effector memory T cells||||< 0.0001
71766100|NCT02720107|143034083|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Naïve T cells||||< 0.0001
71766101|NCT02720107|143034083|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Central memory T cells||||< 0.0001
71766102|NCT02720107|143034083|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Effector memory T cells||||< 0.0001
71766103|NCT02720107|143034083|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||TH17 central memory cells||||< 0.0001
71766104|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-1.0|0.57||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||0.57|-1.00|
71827098|NCT03670602|143158623|SUPERIORITY|||||||0.0003||||||This is for the time effect, or if percent of time engaged in moderate-to-vigorous physical activity (MVPA) changed across timepoints, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.0003
71660992|NCT04430855|142835627|SUPERIORITY||Adjusted Response Rate Difference|4.5||||0.323|TWO_SIDED|95.0|-14.6|23.5||Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Cochran-Mantel-Haenszel||Response rate difference = upadacitinib 30 mg - placebo (in-trial + synthetic)|As a supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was further analyzed by comparing upadacitinib with in-trial placebo participants combined with subjects with historical placebo NRS30 data pre-selected using propensity score matching from adalimumab studies M11-313 and M11-810 and risankizumab study M16-833 (NCT03926169), whose study populations, entry criteria and study designs were similar to this study. The placebo in-trial + synthetic NRS30 was 31.3%.||23.5|-14.6|0.323
71711673|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.25|-0.39||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.39|-1.25|<0.001
71711674|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.22||0.572|TWO_SIDED|95.0|-0.31|0.55||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.55|-0.31|0.572
71711675|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.22||0.467|TWO_SIDED|95.0|-0.27|0.59||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.59|-0.27|0.467
71711676|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.73|-0.82||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.82|-1.73|<0.001
71711677|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.61|-0.7||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.70|-1.61|<0.001
71711678|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.003|TWO_SIDED|95.0|-1.16|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-1.16|0.003
71711679|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.23||0.015|TWO_SIDED|95.0|-1.03|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-1.03|0.015
71711680|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.053|TWO_SIDED|95.0|-0.91|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.91|0.053
71711681|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.66|-0.75||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.75|-1.66|<0.001
71711682|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.56|-0.65||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.65|-1.56|<0.001
71711683|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.23||0.009|TWO_SIDED|95.0|-1.07|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.07|0.009
71711684|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.011|TWO_SIDED|95.0|-1.05|-0.14||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.14|-1.05|0.011
71711685|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.23||0.035|TWO_SIDED|95.0|-0.95|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.95|0.035
71711686|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.79|-0.85||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.85|-1.79|<0.001
71711687|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.71|-0.76||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.76|-1.71|<0.001
71711688|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.008
71655905|NCT04764630|142830220|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.98||||0.018|ONE_SIDED|95.6|1.03|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 2 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.03|0.018
71766105|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.53|1.11||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||1.11|-0.53|
71766106|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.748|||||TWO_SIDED|95.0|-0.02|1.52||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||1.52|-0.02|
71766107|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.207|||||TWO_SIDED|95.0|-2.01|-0.41||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||-0.41|-2.01|
71766108|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.991|||||TWO_SIDED|95.0|0.18|1.81||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7 , pre-breakfast||1.81|0.18|
71766109|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.497|||||TWO_SIDED|95.0|0.66|2.34||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.34|0.66|
71766110|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.955|||||TWO_SIDED|95.0|1.16|2.75||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||2.75|1.16|
71766111|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78|||||TWO_SIDED|95.0|-1.74|0.18||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||0.18|-1.74|
71766112|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.188|||||TWO_SIDED|95.0|-0.81|1.19||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||1.19|-0.81|
71655906|NCT04764630|142830221|SUPERIORITY|To demonstrate an increase in naloxone concentration, the lower bound of the one-sided 97.79% interval for the geometric mean ratio must exclude 1. The results will be transformed back to the original scale by exponentiation to provide treatment geometric means.|Geometric mean ratio|1.69||||0.013|ONE_SIDED|95.6|1.06|||Testing will be conducted sequentially (i.e., start at the initial time and progress forward, stopping if success is achieved) at a 1-sided 0.0221 significance level since an increase in naloxone exposure is expected.|t-test, 1 sided||Data is shown for 4.5-minute timepoint (first time point tested where an increased was observed). This compares results from the 4 naloxone dose arm (2 doses every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Up to three different time points have been pre-specified for the comparison (4.5, 7, and 10 minutes). Time points will be evaluated from earliest to latest time. Testing will proceed until either one passes or all pre-specified time points fail. Subject-level naloxone concentrations will be log-transformed. Naloxone concentrations below the lower limit of quantification will result in that time point from that subject being removed for comparisons involving that treatment arm.|This was the first timepoint in the comparison that showed an increase in the 4 naloxone dose arm (2 doses every 2.5 min) compared to the 4 naloxone dose arm (1 every 2.5 min) and is the reported outcome for this endpoint.||1.06|0.013
71655907|NCT04764630|142830222|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.89||||0.1|TWO_SIDED|90.0|0.78|1.0|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.00|0.78|0.10
71655908|NCT04764630|142830222|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.77||||0.018|TWO_SIDED|90.0|0.65|0.92|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.92|0.65|0.018
71655909|NCT04764630|142830222|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.87||||0.12|TWO_SIDED|90.0|0.75|1.01|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for Cmax will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||1.01|0.75|0.12
71827099|NCT03670602|143158624|SUPERIORITY|||||||0.007||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in calorie intake across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.007
71827100|NCT03670602|143158624|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in calorie intake, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
71827101|NCT03670602|143158625|SUPERIORITY|||||||0.774||||||This is for the treatment group x time effect, or if treatment differentially influenced changes in working memory across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.774
71827102|NCT03670602|143158625|SUPERIORITY|||||||0.019||||||This is for the time effect, or if time influenced changes in working memory, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.019
71827103|NCT03670602|143158626|SUPERIORITY|||||||0.65||||||This is for the treatment group x time effect, or if treatment differentially influenced relative reinforcing efficacy of unhealthy food across all three timepoints. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||0.650
71827104|NCT03670602|143158626|SUPERIORITY||||||<|0.0001||||||This is for the time effect, or if time influenced changes in relative reinforcing efficacy of unhealthy food, independent of treatment group. The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Analyses were Intention to Treat (ITT) and included all randomized participants||A mixed model ANCOVA with unstructured covariance and random effects of participant. Group and cohort were the between subject variables, weeks as the repeated measure and site as a covariate||||<0.0001
71827105|NCT01456936|143158627|SUPERIORITY_OR_OTHER|||||||0.0652||||||An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.|Regression, Linear|A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis.||The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.||||0.0652
71827106|NCT01456936|143158628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.28|||||TWO_SIDED|95.0|-2.4|-0.15|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model.|Non-psychiatric cohort||-0.15|-2.40|
71827107|NCT01456936|143158628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08|||||TWO_SIDED|95.0|-1.37|1.21|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Non-psychiatric cohort||1.21|-1.37|
71827108|NCT01456936|143158628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21|||||TWO_SIDED|95.0|-1.54|1.12|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Non-psychiatric cohort||1.12|-1.54|
71827109|NCT01456936|143158628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.59|||||TWO_SIDED|95.0|-0.42|3.59|||Regression, Linear||Risk difference for varenicline versus placebo from estimation model|Psychiatric cohort||3.59|-0.42|
71827110|NCT01456936|143158628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.78|||||TWO_SIDED|95.0|-0.24|3.81|||Regression, Linear||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Psychiatric cohort||3.81|-0.24|
71827111|NCT01456936|143158628|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.37|||||TWO_SIDED|95.0|-1.53|2.26|||Regression, Linear||Risk difference for NRT versus placebo from estimation model.|Psychiatric cohort||2.26|-1.53|
71827112|NCT01456936|143158643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|3.2|5.0||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||5.00|3.20|<0.0001
71827113|NCT01456936|143158643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.8|2.85||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.85|1.80|<0.0001
71827114|NCT01456936|143158643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.83|2.9||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.90|1.83|<0.0001
71827115|NCT01456936|143158644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|2.56|4.11||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||4.11|2.56|<0.0001
71766113|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.35|1.55||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||1.55|-0.35|
71827116|NCT01456936|143158644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.46|2.39||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.39|1.46|<0.0001
71711689|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.24||0.005|TWO_SIDED|95.0|-1.16|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-1.16|0.005
71766114|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.069|||||TWO_SIDED|95.0|-2.05|-0.08||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.08|-2.05|
71827117|NCT01456936|143158644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.56|2.55||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.55|1.56|<0.0001
71711690|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.013|TWO_SIDED|95.0|-1.07|-0.12||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.12|-1.07|0.013
71711691|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.76|-0.81||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.81|-1.76|<0.001
71711692|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.58|-0.63||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.63|-1.58|<0.001
71711693|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|-0.95|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.00|-0.95|0.050
71711694|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.29|-0.34||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.34|-1.29|<0.001
71766115|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.289|||||TWO_SIDED|95.0|-0.71|1.29||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||1.29|-0.71|
71766116|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.257|||||TWO_SIDED|95.0|0.22|2.29||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.29|0.22|
71827118|NCT01456936|143158645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61|||<|0.0001|TWO_SIDED|95.0|3.07|4.24||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||4.24|3.07|<0.0001
71766117|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.669|||||TWO_SIDED|95.0|0.68|2.65||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||2.65|0.68|
71827119|NCT01456936|143158645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.0001|TWO_SIDED|95.0|1.75|2.45||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.45|1.75|<0.0001
71711695|NCT00863304|142940292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.24||0.009|TWO_SIDED|95.0|-1.11|-0.16||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.16|-1.11|0.009
71711696|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
71766118|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|||||TWO_SIDED|95.0|-1.65|0.54||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||0.54|-1.65|
71766119|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.745|||||TWO_SIDED|95.0|-0.4|1.89||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||1.89|-0.40|
71766120|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.711|||||TWO_SIDED|95.0|-0.36|1.78||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.78|-0.36|
71766121|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-2.15|0.09||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||0.09|-2.15|
71766122|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.474|||||TWO_SIDED|95.0|-0.66|1.61||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||1.61|-0.66|
71766123|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.775|||||TWO_SIDED|95.0|0.6|2.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.95|0.60|
71766124|NCT01128621|143034153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.741|||||TWO_SIDED|95.0|0.63|2.86||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||2.86|0.63|
71766125|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195|||||TWO_SIDED|95.0|-17.17|17.56||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast||17.56|-17.17|
71766126|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.863|||||TWO_SIDED|95.0|-34.7|0.98||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast||0.98|-34.70|
71766127|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.46|||||TWO_SIDED|95.0|-23.04|12.12||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast||12.12|-23.04|
71827120|NCT01456936|143158645|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15|||<|0.0001|TWO_SIDED|95.0|1.82|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.54|1.82|<0.0001
71827121|NCT01456936|143158646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.99|||<|0.0001|TWO_SIDED|95.0|2.33|3.83||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.83|2.33|<0.0001
71766128|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85|||||TWO_SIDED|95.0|-13.89|21.58||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast||21.58|-13.89|
71711697|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
71711698|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
71711699|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
71711700|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
71711701|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.56|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.56|<0.001
71711702|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.58|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.58|<0.001
71711703|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|<0.001
71711704|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.102
71711705|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.066|TWO_SIDED|95.0|-0.31|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.31|0.066
71711706|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.28||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.28|-0.60|<0.001
71711707|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.21||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.21|-0.53|<0.001
71711708|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|-0.34|-0.02||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.02|-0.34|0.027
71827122|NCT01456936|143158646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001|TWO_SIDED|95.0|1.54|2.59||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.59|1.54|<0.0001
71827123|NCT01456936|143158646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.51|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.54|1.51|<0.0001
71711709|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.42|-0.1||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.10|-0.42|0.001
71711710|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.020
71711711|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.17||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.17|-0.49|<0.001
71711712|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08||0.001|TWO_SIDED|95.0|-0.43|-0.11||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.11|-0.43|0.001
71711713|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.328|TWO_SIDED|95.0|-0.24|0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.08|-0.24|0.328
71766129|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.655|||||TWO_SIDED|95.0|-21.7|14.39||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||14.39|-21.70|
71766130|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.712|||||TWO_SIDED|95.0|-39.25|-2.17||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||-2.17|-39.25|
71827124|NCT01456936|143158647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.9|3.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||3.29|1.90|<0.0001
71655910|NCT04764630|142830223|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.83||||0.002|TWO_SIDED|90.0|0.76|0.91|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.91|0.76|0.002
71655911|NCT04764630|142830223|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.75|||<|0.001|TWO_SIDED|90.0|0.7|0.81|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.81|0.70|<0.001
71655912|NCT04764630|142830223|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.97|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-inf will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.97|0.85|0.014
71655913|NCT04764630|142830224|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.82||||0.001|TWO_SIDED|90.0|0.75|0.89|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (1 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.89|0.75|0.001
71655914|NCT04764630|142830224|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.74|||<|0.001|TWO_SIDED|90.0|0.69|0.8|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 2 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.80|0.69|<0.001
71660993|NCT04430855|142835627|SUPERIORITY||Adjusted Response Rate Difference|2.2||||0.421|TWO_SIDED|95.0|-19.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline Hurley Stage \[Stage \< III, Stage III\] and prior TNF use \[Yes or No\])|Response rate difference = upadacitinib 30 mg - placebo|As an additional supplemental analysis, the percentage of participants who achieved NRS30 at Week 12 was also analyzed by comparing upadacitinib 30 mg with in-trial placebo participants.||24.0|-19.6|0.421
71660994|NCT04874636|142835638|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.59|0.75|||||Posterior mean difference with 95% credible interval is reported.|||0.75|-0.59|
71660995|NCT04874636|142835639|SUPERIORITY||Posterior Mean Difference|0.49|||||TWO_SIDED|95.0|-1.02|2.0|||||Posterior mean difference with 95% credible interval is reported.|||2.00|-1.02|
71660996|NCT04874636|142835640|SUPERIORITY||Posterior Mean Difference|0.14|||||TWO_SIDED|95.0|-0.27|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.27|
71660997|NCT04874636|142835641|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.43|1.02|||||Posterior mean difference with 95% credible interval is reported.|||1.02|-0.43|
71660998|NCT04874636|142835642|SUPERIORITY||Posterior Mean Difference|7.9|||||TWO_SIDED|95.0|-0.32|16.14|||||Posterior mean difference with 95% credible interval is reported.|||16.14|-0.32|
71660999|NCT04874636|142835643|SUPERIORITY||Posterior Mean Difference|-0.17|||||TWO_SIDED|95.0|-0.65|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.65|
71661000|NCT04874636|142835644|SUPERIORITY||Posterior Mean Difference|-34.98|||||TWO_SIDED|95.0|-176.34|106.69|||||Posterior mean difference with 95% credible interval is reported.|||106.69|-176.34|
71661001|NCT04874636|142835645|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.1|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-0.10|
71766131|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.31|||||TWO_SIDED|95.0|-27.63|9.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast||9.01|-27.63|
71766132|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.649|||||TWO_SIDED|95.0|-19.43|12.14||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast||12.14|-19.43|
71766133|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.66|||||TWO_SIDED|95.0|-32.72|-0.6||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast||-0.60|-32.72|
71766134|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.251|||||TWO_SIDED|95.0|-38.34|-6.16||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast||-6.16|-38.34|
71766135|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.59|||||TWO_SIDED|95.0|-20.69|11.51||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast||11.51|-20.69|
71766136|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.941|||||TWO_SIDED|95.0|-15.4|17.28||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||17.28|-15.40|
71827125|NCT01456936|143158647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|||<|0.0001|TWO_SIDED|95.0|1.33|2.36||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.36|1.33|<0.0001
71827126|NCT01456936|143158647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.24|2.2||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.||2.20|1.24|<0.0001
71827127|NCT01456936|143158648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.0001|TWO_SIDED|95.0|2.28|3.3||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||3.30|2.28|<0.0001
71711714|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.41|-0.09||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.09|-0.41|0.002
71766137|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.07|||||TWO_SIDED|95.0|-28.82|4.68||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||4.68|-28.82|
71827128|NCT01456936|143158648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89|||<|0.0001|TWO_SIDED|95.0|1.56|2.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.29|1.56|<0.0001
71711715|NCT00863304|142940293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.35|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.35|0.022
71711716|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.35|-0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.04|-0.35|0.012
71766138|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.662|||||TWO_SIDED|95.0|-34.72|-0.6||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast||-0.60|-34.72|
71766139|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.101|||||TWO_SIDED|95.0|-44.0|5.8||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours||5.80|-44.00|
71766140|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.976|||||TWO_SIDED|95.0|-53.56|-2.39||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours||-2.39|-53.56|
71766141|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.609|||||TWO_SIDED|95.0|-48.82|1.6||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours||1.60|-48.82|
71766142|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.094|||||TWO_SIDED|95.0|-22.34|28.53||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours||28.53|-22.34|
71766143|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.194|||||TWO_SIDED|95.0|-48.07|3.69||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours||3.69|-48.07|
71766144|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.07|||||TWO_SIDED|95.0|-57.66|-4.48||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-4.48|-57.66|
71766145|NCT01128621|143034154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.703|||||TWO_SIDED|95.0|-52.98|-0.42||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours||-0.42|-52.98|
71766146|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||0.50|-1.50|
71766147|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.513|||||TWO_SIDED|95.0|-0.51|1.54||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||1.54|-0.51|
71766148|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.05|2.01||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||2.01|0.05|
71766149|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.955|||||TWO_SIDED|95.0|-1.98|0.07||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||0.07|-1.98|
71766150|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.454|||||TWO_SIDED|95.0|-0.59|1.5||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||1.50|-0.59|
71766151|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.468|||||TWO_SIDED|95.0|0.39|2.55||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||2.55|0.39|
71766152|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.985|||||TWO_SIDED|95.0|0.96|3.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||3.01|0.96|
71766153|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312|||||TWO_SIDED|95.0|-1.38|0.76||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||0.76|-1.38|
71766154|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.394|||||TWO_SIDED|95.0|-0.7|1.49||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||1.49|-0.70|
71766155|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.875|||||TWO_SIDED|95.0|-0.18|1.93||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||1.93|-0.18|
71827129|NCT01456936|143158648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.49|2.19||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.||2.19|1.49|<0.0001
71711717|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.113|TWO_SIDED|95.0|-0.28|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.28|0.113
71711718|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.49|-0.18||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.18|-0.49|<0.001
71711719|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.01|0.29||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.29|-0.01|0.076
71711720|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.08||0.007|TWO_SIDED|95.0|0.06|0.37||P-value was based on pairwise comparisons.|ANCOVA|||Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.37|0.06|0.007
71711721|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.26||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.26|-0.57|<0.001
71711722|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
71711723|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.13||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.13|-0.45|<0.001
71711724|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.12|TWO_SIDED|95.0|-0.29|0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.03|-0.29|0.120
71711725|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.29|0.04||P-value was based on pairwise comparisons.|ANCOVA|||Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.04|-0.29|0.126
71711726|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.3||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.30|-0.62|<0.001
71711727|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
71766156|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||||TWO_SIDED|95.0|-1.95|0.25||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||0.25|-1.95|
71766157|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.542|||||TWO_SIDED|95.0|-0.58|1.66||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||1.66|-0.58|
71711728|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
71711729|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.009|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.38|0.009
71711730|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|-0.32|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.32|0.052
71711731|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.25||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.25|-0.57|<0.001
71711732|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.15||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.15|-0.48|<0.001
71766158|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.248|||||TWO_SIDED|95.0|0.09|2.4||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.40|0.09|
71766159|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.729|||||TWO_SIDED|95.0|0.63|2.83||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||2.83|0.63|
71766160|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|||||TWO_SIDED|95.0|-1.21|0.91||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||0.91|-1.21|
71766161|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.737|||||TWO_SIDED|95.0|-0.34|1.81||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||1.81|-0.34|
71766162|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.245|||||TWO_SIDED|95.0|0.21|2.28||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||2.28|0.21|
71711733|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.051|TWO_SIDED|95.0|-0.33|0.0||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.00|-0.33|0.051
71711734|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.41|-0.08||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.08|-0.41|0.003
71711735|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.08||0.069|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.069
71711736|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.24||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.24|-0.57|<0.001
71766163|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.623|||||TWO_SIDED|95.0|-1.71|0.46||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.46|-1.71|
71661002|NCT04682730|142835668|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.18|TWO_SIDED|95.0|0.58|1.11|||Mixed Models Analysis|||||1.11|0.58|0.18
71661003|NCT04682730|142835670|OTHER|single intervention group across 16 clinics|mean total program costs in 2021 dollars|7845.0|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|6378.0|9312.0|||||An opportunity cost approach was used. Costs estimated: Develop workbook- guideline, EHR data analyses, survey, evidence review- \& print; facilitator training/delivery/program tailoring; staff time; implemented strategies; dental sealant placements.|Mean Total Program costs per clinic for the KPNW Dental system.||9312|6378|
71661004|NCT04682730|142835674|OTHER|single intervention group across 16 clinics|mean total costs/per clinic per sealant|1321.0|STANDARD_DEVIATION|1245.0|||TWO_SIDED|95.0|845.0|3208.0|||||Total cost per sealant calculated as quotient of total intervention costs ($125,521) \& total sealants placed (95), is = to mean cost/sealant across each clinic ($7845/5.938).|Mean Total Program costs per sealant per clinic for the KPNW Dental system.||3208|845|
71661005|NCT04682730|142835676|OTHER|descriptive analysis|percentage|100.0|||||TWO_SIDED||||||||||89/89 treatment plans completed by the end of the period.|||
71661006|NCT03258853|142835700|SUPERIORITY|||||||0.001|||||||paired 2-sided t-test|||||||0.001
71661007|NCT03258853|142835701|SUPERIORITY|||||||1||||||Secondary outcomes were adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
71661008|NCT03258853|142835702|SUPERIORITY|||||||0.04||||||Secondary outcomes are adjusted for multiple comparisons|paired 2-sided t-test|||||||0.04
71661009|NCT03258853|142835703|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wicoxon signed rank test|||||||1.0
71661010|NCT03258853|142835704|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
71661011|NCT03258853|142835705|SUPERIORITY|||||||0.014||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.014
71661012|NCT03258853|142835706|SUPERIORITY|||||||0.14||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||0.14
71661013|NCT03258853|142835707|SUPERIORITY|||||||1||||||Adjusted for multiple comparisons|Wilcoxon signed rank test|||||||1.0
71661014|NCT03258853|142835708|SUPERIORITY|||||||0.01|||||||Wilcoxon signed rank test|||||||0.01
71661015|NCT03258853|142835709|SUPERIORITY|||||||0.08|||||||McNemar|||||||0.08
71661016|NCT03258853|142835710|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
71661017|NCT03258853|142835711|SUPERIORITY|||||||0.56|||||||McNemar|||||||0.56
71661018|NCT03258853|142835712|SUPERIORITY|||||||0.15|||||||McNemar|||||||0.15
71661019|NCT01540773|142835747|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71661020|NCT01540773|142835748|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71661021|NCT03753763|142835751|SUPERIORITY||Least square mean difference|0.1||||0.9697|TWO_SIDED|95.0|-6.3|6.5|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||6.5|-6.3|0.9697
71661022|NCT03753763|142835752|SUPERIORITY||least square mean difference|0.5||||0.7751|TWO_SIDED|95.0|-3.1|4.1||A mixed-model repeated measures (MMRM) was used to analyze the change in anterior and lateral displacement from baseline.|Mixed Models Analysis|||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate||4.1|-3.1|0.7751
71661023|NCT03753763|142835753|SUPERIORITY||least square mean difference|0.2||||0.9076|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||3.7|-3.3|0.9076
71661024|NCT03753763|142835754|SUPERIORITY||least square mean difference|-1.1||||0.5386|TWO_SIDED|95.0|-4.8|2.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in UMSARS Part II.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||2.6|-4.8|0.5386
71661025|NCT03753763|142835755|SUPERIORITY||Least square mean difference|6.0||||0.3364|TWO_SIDED|95.0|-6.5|18.6|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change in from baseline in MSA-QoL scale.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||18.6|-6.5|0.3364
71661026|NCT03753763|142835756|SUPERIORITY||Least square mean difference|0.2||||0.7574|TWO_SIDED|95.0|-1.1|1.5|||ANCOVA|||The ANCOVA included change from baseline as the response variable, treatment group as a factor, and baseline score as a covariate||1.5|-1.1|0.7574
71661027|NCT03753763|142835757|SUPERIORITY||Least square mean difference|0.8||||0.6393|TWO_SIDED|95.0|-2.5|4.0|||Mixed Models Analysis|A mixed-model repeated measures (MMRM) was used to analyze the change from baseline in UDRS.||The model included treatment, week of visit, and treatment-by-visit interaction as fixed effects and baseline score as a covariate.||4.0|-2.5|0.6393
71711737|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.20|-0.53|<0.001
71711738|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.37|-0.05||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.05|-0.37|0.012
71711739|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||-0.03|-0.36|0.020
71711740|NCT00863304|142940294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.064|TWO_SIDED|95.0|-0.32|0.01||P-value was based on pairwise comparisons.|ANCOVA|||Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.||0.01|-0.32|0.064
71711741|NCT02947048|142940362|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.42||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.61
71711742|NCT02947048|142940362|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.52||0.33|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Severity||||0.33
71711743|NCT02947048|142940362|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.47||0.61|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.61
71711744|NCT02947048|142940362|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.43||0.91|TWO_SIDED||||||ANCOVA|||Clinical Global Impression - Improvement||||0.91
71711745|NCT03895372|142940389|SUPERIORITY||Risk Difference (RD)|8.87||||0.2621|TWO_SIDED|90.0|-4.5|26.26||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||26.26|-4.50|0.2621
71711746|NCT03895372|142940389|SUPERIORITY||Risk Difference (RD)|4.76||||0.2621|TWO_SIDED|90.0|-7.07|21.48||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||21.48|-7.07|0.2621
71711747|NCT03895372|142940389|SUPERIORITY||Risk Difference (RD)|33.02||||0.0004|TWO_SIDED|90.0|18.01|47.11||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||47.11|18.01|0.0004
71711748|NCT03895372|142940389|SUPERIORITY||Risk Difference (RD)|46.46|||<|0.0001|TWO_SIDED|90.0|30.62|60.56||One-sided Hochberg p-value, significant level is 0.05.|Chan and Zhang method|||The analysis was based on the data at Week 16.||60.56|30.62|<0.0001
71711749|NCT03895372|142940397|SUPERIORITY||Risk Difference (RD)|3.9|||||TWO_SIDED|90.0|-11.82|23.42||||||The analysis was based on the data at Week 16.||23.42|-11.82|
71766164|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.62|1.57||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||1.57|-0.62|
71886760|NCT00523991|143293830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88||||0.064||95.0|-12.1|0.35||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo||0.35|-12.10|0.064
71711750|NCT03895372|142940397|SUPERIORITY||Risk Difference (RD)|-4.76|||||TWO_SIDED|90.0|-18.61|13.29||||||The analysis was based on the data at Week 16.||13.29|-18.61|
71711751|NCT03895372|142940397|SUPERIORITY||Risk Difference (RD)|32.38|||||TWO_SIDED|90.0|14.32|47.52||||||The analysis was based on the data at Week 16.||47.52|14.32|
71711752|NCT03895372|142940397|SUPERIORITY||Risk Difference (RD)|58.89|||||TWO_SIDED|90.0|41.01|72.41||||||The analysis was based on the data at Week 16.||72.41|41.01|
71711753|NCT03895372|142940398|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
71711754|NCT03895372|142940398|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
71711755|NCT03895372|142940398|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
71711756|NCT03895372|142940398|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
71711757|NCT03895372|142940399|SUPERIORITY||Risk Difference (RD)|1.52|||||TWO_SIDED|90.0|-14.52|20.77||||||The analysis was based on the data at Week 16.||20.77|-14.52|
71711758|NCT03895372|142940399|SUPERIORITY||Risk Difference (RD)|-2.38|||||TWO_SIDED|90.0|-17.67|17.01||||||The analysis was based on the data at Week 16.||17.01|-17.67|
71711759|NCT03895372|142940399|SUPERIORITY||Risk Difference (RD)|27.78|||||TWO_SIDED|90.0|8.86|43.26||||||The analysis was based on the data at Week 16.||43.26|8.86|
71711760|NCT03895372|142940399|SUPERIORITY||Risk Difference (RD)|54.07|||||TWO_SIDED|90.0|36.46|68.27||||||The analysis was based on the data at Week 16.||68.27|36.46|
71711761|NCT03895372|142940402|SUPERIORITY||Least Squares Mean Difference|-1.46|||||TWO_SIDED|90.0|-5.42|2.51||||||The analysis was based on the data at Week 16.||2.51|-5.42|
71711762|NCT03895372|142940402|SUPERIORITY||Least Squares Mean Difference|-3.54|||||TWO_SIDED|90.0|-7.5|0.42||||||The analysis was based on the data at Week 16.||0.42|-7.50|
71711763|NCT03895372|142940402|SUPERIORITY||Least Squares Mean Difference|-9.8|||||TWO_SIDED|90.0|-13.05|-6.56||||||The analysis was based on the data at Week 16.||-6.56|-13.05|
71711764|NCT03895372|142940402|SUPERIORITY||Least Squares Mean Difference|-12.33|||||TWO_SIDED|90.0|-15.61|-9.04||||||The analysis was based on the data at Week 16.||-9.04|-15.61|
71711765|NCT03895372|142940403|SUPERIORITY||Least Squares Mean Difference|-8.63|||||TWO_SIDED|90.0|-23.61|6.35||||||The analysis was based on the data at Week 16.||6.35|-23.61|
71711766|NCT03895372|142940403|SUPERIORITY||Least Squares Mean Difference|-13.02|||||TWO_SIDED|90.0|-27.98|1.94||||||The analysis was based on the data at Week 16.||1.94|-27.98|
71766165|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.36|||||TWO_SIDED|95.0|0.23|2.49||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.49|0.23|
71766166|NCT01128621|143034157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.869|||||TWO_SIDED|95.0|0.79|2.95||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||2.95|0.79|
71827130|NCT00543725|143158652|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.7|||<|0.0001||95.0|-1.6|9.0||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||9.0|-1.6|<0.0001
71827131|NCT00543725|143158653|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.9|||<|0.0001||95.0|-1.9|9.6|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||9.6|-1.9|<0.0001
71886761|NCT00523991|143293832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.718||95.0|-7.21|4.98||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||4.98|-7.21|0.718
71711767|NCT03895372|142940403|SUPERIORITY||Least Squares Mean Difference|-40.74|||||TWO_SIDED|90.0|-53.02|-28.46||||||The analysis was based on the data at Week 16.||-28.46|-53.02|
71711768|NCT03895372|142940403|SUPERIORITY||Least Squares Mean Difference|-53.04|||||TWO_SIDED|90.0|-65.44|-40.63||||||The analysis was based on the data at Week 16.||-40.63|-65.44|
71711769|NCT03895372|142940404|SUPERIORITY||Least Squares Mean Difference|-1.22|||||TWO_SIDED|90.0|-2.52|0.09||||||The analysis was based on the data at Week 16.||0.09|-2.52|
71711770|NCT03895372|142940404|SUPERIORITY||Least Squares Mean Difference|-1.21|||||TWO_SIDED|90.0|-2.46|0.05||||||The analysis was based on the data at Week 16.||0.05|-2.46|
71711771|NCT03895372|142940404|SUPERIORITY||Least Squares Mean Difference|-3.47|||||TWO_SIDED|90.0|-4.51|-2.43||||||The analysis was based on the data at Week 16.||-2.43|-4.51|
71711772|NCT03895372|142940404|SUPERIORITY||Least Squares Mean Difference|-3.66|||||TWO_SIDED|90.0|-4.71|-2.61||||||The analysis was based on the data at Week 16.||-2.61|-4.71|
71711773|NCT03895372|142940405|SUPERIORITY||Risk Difference (RD)|12.99|||||TWO_SIDED|90.0|-4.52|32.87||||||The analysis was based on the data at Week 16.||32.87|-4.52|
71711774|NCT03895372|142940405|SUPERIORITY||Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|2.62|44.64||||||The analysis was based on the data at Week 16.||44.64|2.62|
71711775|NCT03895372|142940405|SUPERIORITY||Risk Difference (RD)|41.27|||||TWO_SIDED|90.0|23.47|56.18||||||The analysis was based on the data at Week 16.||56.18|23.47|
71711776|NCT03895372|142940405|SUPERIORITY||Risk Difference (RD)|49.13|||||TWO_SIDED|90.0|30.62|63.69||||||The analysis was based on the data at Week 16.||63.69|30.62|
71711777|NCT03895372|142940406|SUPERIORITY||Least Squares Mean Difference|-4.21|||||TWO_SIDED|90.0|-7.82|-0.59||||||The analysis was based on the data at Week 16.||-0.59|-7.82|
71711778|NCT03895372|142940406|SUPERIORITY||Least Squares Mean Difference|-6.44|||||TWO_SIDED|90.0|-9.89|-2.99||||||The analysis was based on the data at Week 16.||-2.99|-9.89|
71711779|NCT03895372|142940406|SUPERIORITY||Least Squares Mean Difference|-10.51|||||TWO_SIDED|90.0|-13.4|-7.62||||||The analysis was based on the data at Week 16.||-7.62|-13.40|
71711780|NCT03895372|142940406|SUPERIORITY||Least Squares Mean Difference|-10.81|||||TWO_SIDED|90.0|-13.68|-7.94||||||The analysis was based on the data at Week 16.||-7.94|-13.68|
71711781|NCT03331354|142940420|SUPERIORITY||Cox Proportional Hazard|1.87|||=|0.016|TWO_SIDED||||||Chi-squared|||||||=.016
71711782|NCT03331354|142940421|SUPERIORITY|||||||0.008|||||||ANCOVA|Initial interview scores were used as control in the ANCOVA||||||.008
71711783|NCT03331354|142940422|SUPERIORITY|||||||0.99|||||||ANCOVA|Change in confidence was evaluated using time one as a covariate.||||||.99
71711784|NCT03331354|142940422|SUPERIORITY|||||||0.99|||||||ANCOVA|Interview scores at enrollment were used as a covariate||||||.99
71711785|NCT03331354|142940423|OTHER||||||<|0.001|||||||Pearson Correlation|||This post-hoc analysis was performed on only the COMPASS group to determine the association between percent of the online system completed and change in interview scores||||<.001
71711786|NCT04047355|142940428|SUPERIORITY||Median Difference (Final Values)|3.0||||0.12|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.12
71711787|NCT04047355|142940428|SUPERIORITY||Effect size (r)|-0.64|||||TWO_SIDED|||||||||||||
71711788|NCT04047355|142940428|SUPERIORITY||Post-hoc power analysis|0.39|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
71711789|NCT04047355|142940429|SUPERIORITY||Median Difference (Final Values)|2.0||||0.07|TWO_SIDED|||||The a-priori threshold for statistical significance was set at α = 0.05.|Wilcoxon (Mann-Whitney)||The placebo phase serves as the control condition and the propranolol phase serves as the treatment condition.|A post-hoc power analysis was conducted using G\*Power, v. 3.1, to determine the achieved power for the Wilcoxon signed-rank test for matched pairs.||||0.07
71711790|NCT04047355|142940429|SUPERIORITY||Effect size (r)|-0.74|||||TWO_SIDED|||||||||||||
71711791|NCT04047355|142940429|SUPERIORITY||Post-hoc power analysis|0.59|||||TWO_SIDED||||||||The alpha error probability was set at α = 0.05 (two-tailed).|||||
71711792|NCT05889468|142940430|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test, a non-parametric test, was used since the empirical distribution of data did not follow the normality assumption.||This was an intention-to-treat analysis.||||0.49
71711793|NCT05889468|142940431|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Intention-to-treat analysis||||0.32
71711794|NCT05889468|142940433|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
71711795|NCT05889468|142940434|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Intention-to-treat analysis||||>0.99
71711796|NCT05468918|142940441|OTHER|||||||0.002|||||||ANOVA|||||||0.002
71711797|NCT05468918|142940442|OTHER|||||||0.023|||||||ANOVA|||||||0.023
71711798|NCT03900650|142940457|OTHER||Mean Difference (Final Values)|7.32|||<|0.01|TWO_SIDED||||||ANOVA|||||||<.01
71711799|NCT03900650|142940458|OTHER||Mean Difference (Final Values)|0.377||||0.77|TWO_SIDED|||||This p-value tests the effect of the study arms on number of sex events.|ANOVA|||||||.770
71711800|NCT00427700|142940459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.0||||0.3|TWO_SIDED|95.0|-9.0|33.0|||Fisher Exact|||The null hypothesis is that there is no significant difference between two drugs for ovulation induction.A sample size of 40 women per arm was calculated for this superiority trial, considering an alpha and beta error of 0.05 and 0.2, respectively, to find an absolute difference of 30% in the ovulation rate between groups, based on a previous study published by Mitwally and Casper (18) where the ovulation rate with CC was approximately 45%.||33|-9|0.3
71711801|NCT00427700|142940460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.2|TWO_SIDED|95.0|-6.0|34.0|||t-test, 2 sided|||Null hypothesis: There is no difference between the mean values of progesterone between both groups.||34|-6|0.2
71766167|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.619|||||TWO_SIDED|95.0|-59.25|2.01||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7||2.01|-59.25|
71766168|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.898|||||TWO_SIDED|95.0|-79.23|-16.56||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7||-16.56|-79.23|
71711802|NCT00721110|142940472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.96|TWO_SIDED|97.5|-52.0|54.0||Significant if P \< 0.003 for efficacy and P \> 0.5311 for futility; 97.5% confidence intervals adjusted for group sequential design to maintain the overall alpha of 0.025 for each primary intervention.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||54|-52|0.96
71711803|NCT00721110|142940472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.54|TWO_SIDED|97.5|-65.0|44.0||97.5% confidence interval adjusted for group sequential design (using confidence coefficient of 2.97) to maintain theoverall α of 0.025 for each primary intervention and 0.05 for the trial.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.||44|-65|0.54
71711804|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.2|TWO_SIDED|97.5|-3.3|1.3||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Groups compared on VRS scores at PACU admit using a t test.||1.3|-3.3|0.20
71711805|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.54|TWO_SIDED|97.5|-2.8|1.9||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine compared to placebo at PACU admit using a t test||1.9|-2.8|0.54
71711806|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.11|TWO_SIDED|97.5|-2.5|0.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.||0.8|-2.5|0.11
71711807|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.56|TWO_SIDED|97.5|-1.4|2.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.||2.0|-1.4|0.56
71711808|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.2|TWO_SIDED|97.5|-0.9|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.||2.2|-0.9|0.20
71711809|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|97.5|-1.4|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.||1.7|-1.4|0.79
71766169|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.665|||||TWO_SIDED|95.0|-55.53|6.2||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7||6.20|-55.53|
71766170|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.438|||||TWO_SIDED|95.0|-36.76|25.89||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||25.89|-36.76|
71766171|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.181|||||TWO_SIDED|95.0|-55.0|8.63||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||8.63|-55.00|
71766172|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.46|||||TWO_SIDED|95.0|-75.18|-9.74||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||-9.74|-75.18|
71766173|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.227|||||TWO_SIDED|95.0|-51.83|13.37||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7||13.37|-51.83|
71766174|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.435|||||TWO_SIDED|95.0|-49.15|12.28||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14||12.28|-49.15|
71711810|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|97.5|-1.1|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.||1.7|-1.1|0.55
71711811|NCT00721110|142940473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.47|TWO_SIDED|97.5|-1.1|1.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.||1.8|-1.1|0.47
71711812|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.63|TWO_SIDED|97.5|-7.0|7.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.||7|-7|0.63
71711813|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.0||||0.27|TWO_SIDED|97.5|-10.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.||5|-10|0.27
71711814|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.28|TWO_SIDED|97.5|-15.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||5|-15|0.28
71766175|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.658|||||TWO_SIDED|95.0|-90.08|-27.24||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14||-27.24|-90.08|
71766176|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.006|||||TWO_SIDED|95.0|-67.96|-6.05||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14||-6.05|-67.96|
71827132|NCT00543725|143158654|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|2.4|||<|0.0001||95.0|-3.6|8.4||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||8.4|-3.6|<0.0001
71827133|NCT00543725|143158655|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.7|||<|0.0001||95.0|-5.6|7.0|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||7.0|-5.6|<0.0001
71827134|NCT00906698|143158670|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|126.2|||||TWO_SIDED|90.0|69.549|229.012|||ANOVA|||||229.012|69.549|
71827135|NCT00906698|143158671|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|75.58|||||TWO_SIDED|90.0|65.037|87.837|||ANOVA|||||87.837|65.037|
71827136|NCT00906698|143158672|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|132.8|||||TWO_SIDED|90.0|72.305|243.917|||ANOVA|||||243.917|72.305|
71711815|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.22|TWO_SIDED|97.5|-15.0|4.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.||4|-15|0.22
71711816|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.76|TWO_SIDED|97.5|-13.0|21.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||21|-13|0.76
71711817|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0||||0.66|TWO_SIDED|97.5|-19.0|14.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.||14|-19|0.66
71766177|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.896|||||TWO_SIDED|95.0|-41.31|21.52||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||21.52|-41.31|
71766178|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.539|||||TWO_SIDED|95.0|-40.44|23.36||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||23.36|-40.44|
71827137|NCT00906698|143158673|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.8|||||TWO_SIDED|90.0|61.156|114.823|||ANOVA|||||114.823|61.156|
71766179|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.762|||||TWO_SIDED|95.0|-81.58|-15.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||-15.95|-81.58|
71766180|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.11|||||TWO_SIDED|95.0|-59.8|5.58||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14||5.58|-59.80|
71766181|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.359|||||TWO_SIDED|95.0|-48.95|8.23||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14||8.23|-48.95|
71766182|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.712|||||TWO_SIDED|95.0|-82.92|-24.5||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14||-24.50|-82.92|
71655915|NCT04764630|142830224|OTHER|Treatment differences on the log-scale will be estimated for the PK parameters. Geometric mean ratio and 90% CIs will be obtained by exponentiation of the treatment effect and 90% CIs based on the log-transformed scale. Dose-proportionality will be concluded if the confidence interval includes 1. Dose-normalized comparisons were exploratory.|Geometric mean ratio|0.91||||0.014|TWO_SIDED|90.0|0.85|0.96|||Mixed Models Analysis|Dose-normalized comparisons were exploratory.|This compares results from the 4 naloxone dose arm (2 every 2.5 min) (numerator) with the 4 naloxone dose arm (1 every 2.5 min) (denominator).|Dose-adjusted values for AUC0-t will be calculated based on noncompartmental PK parameter results, normalized to per mg of naloxone administered. Using linear mixed-effects modeling, comparisons of log-transformed dose-adjusted PK parameters will be performed. Treatment will be a fixed effect. Participant will be included as a random effect on the intercept.||0.96|0.85|0.014
71655916|NCT00899470|142830234|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.011|||||TWO_SIDED|90.0|0.94|1.088|||Mixed Models Analysis|Bioequivalence=90% confidence intervals (CIs) for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.940|
71655917|NCT00899470|142830234|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs Reference|0.999|||||TWO_SIDED|90.0|0.929|1.075||||Bioequivalence=90% CIs for the test|For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.075|0.929|
71655918|NCT00899470|142830235|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.993|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.993|
71655919|NCT00899470|142830235|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio|1.021|||||TWO_SIDED|90.0|0.986|1.058|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.058|0.986|
71661028|NCT03433755|142835760|SUPERIORITY||Treatment difference|-70.73|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-77.98|-63.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-63.48|-77.98|< 0.0001
71661029|NCT03433755|142835760|SUPERIORITY||Treatment difference|-69.74|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-76.51|-62.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-62.97|-76.51|< 0.0001
71661030|NCT03433755|142835761|SUPERIORITY||Treatment difference|-70.87|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-79.47|-62.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-62.27|-79.47|< 0.0001
71661031|NCT03433755|142835761|SUPERIORITY||Treatment difference|-65.81|STANDARD_ERROR_OF_MEAN|4.11|<|0.0001|TWO_SIDED|95.0|-73.97|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-57.66|-73.97|< 0.0001
71766183|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.552|||||TWO_SIDED|95.0|-66.24|-8.86||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14||-8.86|-66.24|
71827138|NCT00906698|143158676|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|90.21|||||TWO_SIDED|90.0|76.071|106.978|||ANOVA|||||106.978|76.071|
71766184|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.963|||||TWO_SIDED|95.0|-37.2|21.27||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||21.27|-37.20|
71711818|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.3|TWO_SIDED|97.5|-5.0|10.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||10|-5|0.30
71711819|NCT00721110|142940474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|97.5|-5.0|8.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.||8|-5|0.79
71711820|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.58|TWO_SIDED|97.5|-0.28|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||numerator: lidocaine; denominator: control|Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.41|-0.28|0.58
71711821|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.02||||0.87|TWO_SIDED|97.5|-0.32|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||Numinator: ketamine; denominator: nonketamine|Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.||0.36|-0.32|0.87
71766185|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.397|||||TWO_SIDED|95.0|-42.1|17.3||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||17.30|-42.10|
71766186|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.749|||||TWO_SIDED|95.0|-76.2|-15.3||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||-15.30|-76.20|
71766187|NCT01128621|143034158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.59|||||TWO_SIDED|95.0|-59.82|0.64||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14||0.64|-59.82|
71766188|NCT00913458|143034202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.7|12.5||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||12.5|2.7|<0.0001
71766189|NCT00913458|143034202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0085|TWO_SIDED|95.0|1.3|5.3||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.3|1.3|0.0085
71827139|NCT00906698|143158677|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|76.75|||||TWO_SIDED|90.0|56.71|103.871|||ANOVA|||||103.871|56.710|
71711822|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.61|TWO_SIDED|97.5|-0.31|0.44||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.||0.44|-0.31|0.61
71827140|NCT00906698|143158678|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|83.86|||||TWO_SIDED|95.0|66.369|105.966|||ANOVA|||||105.966|66.369|
71766190|NCT00913458|143034202|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0397|TWO_SIDED|95.0|1.0|4.8||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Linear|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|1.0|0.0397
71766191|NCT00913458|143034203|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~End of Phase 1"||||<0.0001
71827141|NCT00906698|143158679|SUPERIORITY_OR_OTHER||Ratio of adjusted gMean|81.7|||||TWO_SIDED|90.0|60.47|110.369|||ANOVA|||||110.369|60.470|
71827142|NCT03095508|143158682|SUPERIORITY|||||||0.446|||||||Fisher Exact|||||||0.446
71766192|NCT00913458|143034204|SUPERIORITY_OR_OTHER|||||||0.1183|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.1183
71766193|NCT00913458|143034204|SUPERIORITY_OR_OTHER|||||||0.0286|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0286
71766194|NCT00913458|143034205|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
71766195|NCT00913458|143034206|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
71766196|NCT00913458|143034207|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13"||||0.0063
71766197|NCT00913458|143034207|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 26"||||0.0053
71766198|NCT00913458|143034207|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 39"||||0.0027
71827143|NCT03095508|143158684|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71827144|NCT03095508|143158685|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
71827145|NCT03095508|143158686|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
71827146|NCT03095508|143158687|NON_INFERIORITY|non-inferiority margin 14.5% absolute difference between percentages in group A and B|Risk Difference (RD)|0.14||||1e-05|TWO_SIDED|95.0|0.03|0.24||p- value for superiority: 0.021|Fisher Exact|||p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 - p2 ≤ -0.145||0.24|0.03|0.00001
71827147|NCT01585038|143158703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.3|TWO_SIDED|95.0|-1.56|2.64|||t-test, 1 sided|||||2.64|-1.56|0.30
71827148|NCT01585038|143158704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.21||||0.35|TWO_SIDED|95.0|-4.71|2.3|||t-test, 2 sided|||||2.30|-4.71|0.35
71661032|NCT03433755|142835762|SUPERIORITY||Treatment difference|-76.5|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-86.6|-66.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-66.4|-86.6|< 0.0001
71766199|NCT00913458|143034207|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 52"||||0.0002
71766200|NCT00913458|143034207|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Final on therapy"||||0.0005
71766201|NCT00913458|143034208|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"||||<0.0001
71766202|NCT00913458|143034209|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71766203|NCT00913458|143034210|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71766204|NCT00913458|143034211|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71766205|NCT00913458|143034212|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71766206|NCT00913458|143034213|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71766207|NCT00913458|143034214|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71766208|NCT00913458|143034215|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||"Significance tests were based on paired t-tests using a 2-sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71766209|NCT00913458|143034216|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"||||<0.0001
71766210|NCT00913458|143034217|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71766211|NCT00913458|143034218|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||McNemar|||"P-value is from McNemar's test for no change from baseline in response rate.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"||||<0.0001
71827149|NCT01585038|143158705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.41|TWO_SIDED|95.0|-62.49|75.89|||t-test, 2 sided|||||75.89|-62.49|0.41
71827150|NCT01585038|143158706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-194.1||||0.02|TWO_SIDED|95.0|-353.7|-34.6|||t-test, 2 sided|||||-34.6|-353.7|0.02
71827151|NCT01156116|143158758|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.03
71827152|NCT01156116|143158759|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.04
71661033|NCT03433755|142835762|SUPERIORITY||Treatment difference|-77.2|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|95.0|-87.7|-66.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-66.7|-87.7|< 0.0001
71661034|NCT03433755|142835763|SUPERIORITY||Treatment difference|-75.9|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-87.1|-64.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-64.7|-87.1|< 0.0001
71661035|NCT03433755|142835763|SUPERIORITY||Treatment difference|-73.0|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-84.1|-61.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-61.8|-84.1|< 0.0001
71661036|NCT03433755|142835764|SUPERIORITY||Treatment difference|-61.2|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-68.04|-54.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.37|-68.04|< 0.0001
71661037|NCT03433755|142835764|SUPERIORITY||Treatment difference|-62.15|STANDARD_ERROR_OF_MEAN|2.94|<|0.0001|TWO_SIDED|95.0|-67.97|-56.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-56.32|-67.97|< 0.0001
71661038|NCT03433755|142835765|SUPERIORITY||Treatment difference|-61.45|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-69.25|-53.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.65|-69.25|< 0.0001
71827153|NCT01156116|143158760|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||0.009
71711823|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.03||||0.79|TWO_SIDED|97.5|-0.34|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.||0.41|-0.34|0.79
71827154|NCT01156116|143158761|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.||||||<0.001
71827155|NCT02057718|143158766|OTHER|Null hypothesis (H0): mean change from baseline to Week 13 is zero. The null hypothesis was tested for each of the 2 PFIC subgroups and overall; the change in the overall population is presented here.|Mean Difference (Net)|-23.304|STANDARD_DEVIATION|160.9748|||TWO_SIDED|95.0|-82.35|35.742||||||This analysis shows the change from baseline to Week 13 in sBA levels for the overall Modified Intent-to-treat Population. Even though a comparison of PFIC1 vs PFIC2 (overall) is noted, the results are the change from baseline for all participants and is not comparative.||35.742|-82.35|
71827156|NCT01245439|143158793|SUPERIORITY_OR_OTHER|||||||0.929|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.929
71827157|NCT01245439|143158793|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to 3||||<0.001
71827158|NCT01245439|143158793|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||<0.001
71827159|NCT01245439|143158793|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.050
71827160|NCT01245439|143158793|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.165
71827161|NCT01245439|143158793|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.133
71827162|NCT01245439|143158793|SUPERIORITY_OR_OTHER|||||||0.217|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.217
71827163|NCT01245439|143158793|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
71827164|NCT01245439|143158796|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.169
71655920|NCT00899470|142830236|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.027|||||TWO_SIDED|90.0|0.99|1.066|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.066|0.990|
71655921|NCT00899470|142830236|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio Test vs. Reference|1.022|||||TWO_SIDED|95.0|0.985|1.06|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.060|0.985|
71655922|NCT00899470|142830238|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.|Geometric Mean Ratio, Test vs. Reference|1.009|||||TWO_SIDED|90.0|0.939|1.084|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.084|0.939|
71827165|NCT01245439|143158796|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
71827166|NCT01245439|143158796|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.053
71827167|NCT01245439|143158796|SUPERIORITY_OR_OTHER|||||||0.514|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.514
71827168|NCT01245439|143158796|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.064
71827169|NCT01245439|143158796|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.038
71827170|NCT01245439|143158796|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.064
71827171|NCT01245439|143158796|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8||||<0.001
71827172|NCT01245439|143158797|SUPERIORITY_OR_OTHER|||||||0.981|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2||||0.981
71827173|NCT01245439|143158797|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3||||<0.001
71711824|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.13||||0.26|TWO_SIDED|97.5|-0.38|0.12||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.||0.12|-0.38|0.26
71711825|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|-0.06||||0.71|TWO_SIDED|97.5|-0.31|0.19||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.||0.19|-0.31|0.71
71711826|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.06||||0.52|TWO_SIDED|97.5|-0.23|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.||0.36|-0.23|0.52
71711827|NCT00721110|142940475|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.07||||0.44|TWO_SIDED|97.5|-0.22|0.38|||Chi-squared|||Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.||0.38|-0.22|0.44
71711828|NCT00721110|142940476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.96|TWO_SIDED|97.5|-2.14|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.||2.2|-2.14|0.96
71711829|NCT00721110|142940476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.59|TWO_SIDED|97.5|-1.8|2.57||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.||2.57|-1.80|0.59
71711830|NCT01554904|142940477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.24|STANDARD_ERROR_OF_MEAN|62.4||0.02|TWO_SIDED|95.0|27.32|297.16|||paired t test|||The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.||297.16|27.32|0.02
71711831|NCT01554904|142940478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.22|TWO_SIDED|95.0|-2.28|0.584||paired t test|t-test, 2 sided|||Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.||0.584|-2.28|0.22
71711832|NCT02038647|142940482|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.113|TWO_SIDED|95.0|0.557|1.067||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.067|0.557|0.113
71711833|NCT02038647|142940484|SUPERIORITY||Cox Proportional Hazard|0.93||||0.714|TWO_SIDED|95.0|0.652|1.341||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.|||1.341|0.652|0.714
71711834|NCT02038647|142940485|SUPERIORITY||Odds Ratio (OR)|0.74||||0.406|TWO_SIDED|95.0|0.35|1.55||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using ORR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.55|0.35|0.406
71827174|NCT01245439|143158797|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4||||0.005
71827175|NCT01245439|143158797|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5||||0.566
71711835|NCT02038647|142940486|SUPERIORITY||Odds Ratio (OR)|0.01||||0.283|TWO_SIDED|95.0|0.01|9999.99||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using CRR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||9999.99|0.01|0.283
71711836|NCT02038647|142940487|SUPERIORITY||Odds Ratio (OR)|0.59||||0.077|TWO_SIDED|95.0|0.32|1.08||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using DCR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.|||1.08|0.32|0.077
71711837|NCT05852340|142940563|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|102.36|||||TWO_SIDED|90.0|95.81|109.35||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||109.35|95.81|
71827176|NCT01245439|143158797|SUPERIORITY_OR_OTHER|||||||0.264|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6||||0.264
71827177|NCT01245439|143158797|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7||||0.126
71827178|NCT01245439|143158797|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8||||0.779
71827179|NCT01245439|143158797|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||||||<0.001
71827180|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints Visit 1 to Visit 2||||0.410
71827181|NCT01245439|143158798|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 3||||<0.001
71711838|NCT05852340|142940563|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|97.15|||||TWO_SIDED|90.0|90.94|103.79||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||103.79|90.94|
71711839|NCT05852340|142940563|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|99.65|||||TWO_SIDED|90.0|93.28|106.46||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||106.46|93.28|
71711840|NCT05852340|142940563|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.84|||||TWO_SIDED|90.0|97.3|112.96||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||112.96|97.30|
71711841|NCT05852340|142940564|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.63|||||TWO_SIDED|90.0|83.66|111.62||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Strawberry Jam (Fasted)||111.62|83.66|
71711842|NCT05852340|142940564|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|84.58|||||TWO_SIDED|90.0|73.23|97.7||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Yoghurt (Fasted)||97.70|73.23|
71711843|NCT05852340|142940564|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|93.91|||||TWO_SIDED|90.0|81.3|108.48||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Mixed with Applesauce (Fasted)||108.48|81.30|
71711844|NCT05852340|142940564|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|43.83|||||TWO_SIDED|90.0|37.5|51.23||||||Reference: Ritlecitinib 30 mg Capsule (Fasted) Test: Ritlecitinib 30 mg Capsule Given with High Fat Meal||51.23|37.50|
71711845|NCT01903863|142940567|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71711846|NCT01903863|142940568|SUPERIORITY|||||||0.07||||||Intracranial hemorrhage|Fisher Exact|||||||0.07
71661039|NCT03433755|142835765|SUPERIORITY||Treatment difference|-56.65|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-63.66|-49.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-49.63|-63.66|< 0.0001
71711847|NCT01903863|142940568|SUPERIORITY|||||||0.7||||||Surgical bleed|Fisher Exact|||||||0.7
71711848|NCT01903863|142940568|SUPERIORITY|||||||0.5||||||Gastrointestinal hemorrhage|Fisher Exact|||||||0.5
71711849|NCT01903863|142940569|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71711850|NCT01903863|142940570|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71711851|NCT01903863|142940571|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71711852|NCT01903863|142940572|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71711853|NCT01903863|142940573|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71711854|NCT01903863|142940574|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71711855|NCT00835367|142940598|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.84||||||90.0|98.22|105.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.59|98.22|
71711856|NCT00835367|142940599|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|102.53||||||90.0|99.71|105.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.44|99.71|
71711857|NCT00835367|142940600|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.49||||||90.0|99.75|105.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.30|99.75|
71711858|NCT00835367|142940601|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|91.79||||||90.0|84.83|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||99.32|84.83|
71711859|NCT00835367|142940602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.85||||||90.0|92.54|99.27|||||Metabolite presented for informational purposes only.|||99.27|92.54|
71711860|NCT00835367|142940603|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.3|102.3|||||Metabolite presented for informational purposes only|||102.30|98.30|
71711861|NCT00835367|142940604|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.74||||||90.0|100.35|105.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.19|100.35|
71827182|NCT01245439|143158798|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 3 to Visit 4||||<0.001
71766212|NCT00913458|143034219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.4075|TWO_SIDED|95.0|0.4|7.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.6|0.4|0.4075
71711862|NCT00835367|142940605|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.72||||||90.0|100.3|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.20|100.30|
71711863|NCT00835367|142940606|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.25|102.35|||||Metabolite presented for informational purposes only.|||102.35|98.25|
71711864|NCT01892189|142940611|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.2348|STANDARD_ERROR_OF_MEAN|0.20458||0.259|TWO_SIDED|95.0|-0.6506|0.1809|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.||0.1809|-0.6506|0.259
71711865|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0367|STANDARD_ERROR_OF_MEAN|0.22075||0.869|TWO_SIDED|95.0|-0.4853|0.4119|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4119|-0.4853|0.869
71711866|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|0.20968||0.306|TWO_SIDED|95.0|-0.6441|0.2081|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2081|-0.6441|0.306
71711867|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2525|STANDARD_ERROR_OF_MEAN|0.17956||0.169|TWO_SIDED|95.0|-0.6174|0.1124|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1124|-0.6174|0.169
71711868|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0417|STANDARD_ERROR_OF_MEAN|0.19375||0.831|TWO_SIDED|95.0|-0.4354|0.3521|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3521|-0.4354|0.831
71711869|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2421|STANDARD_ERROR_OF_MEAN|0.18403||0.197|TWO_SIDED|95.0|-0.6161|0.1319|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1319|-0.6161|0.197
71711870|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1155|STANDARD_ERROR_OF_MEAN|0.1618||0.48|TWO_SIDED|95.0|-0.4443|0.2133|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2133|-0.4443|0.480
71711871|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1673|STANDARD_ERROR_OF_MEAN|0.17458||0.345|TWO_SIDED|95.0|-0.1875|0.5221|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5221|-0.1875|0.345
71711872|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1504|STANDARD_ERROR_OF_MEAN|0.16583||0.371|TWO_SIDED|95.0|-0.4874|0.1866|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1866|-0.4874|0.371
71711873|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1731|STANDARD_ERROR_OF_MEAN|0.18808||0.364|TWO_SIDED|95.0|-0.5553|0.2092|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2092|-0.5553|0.364
71711874|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.20294||0.507|TWO_SIDED|95.0|-0.2762|0.5486|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.5486|-0.2762|0.507
71711875|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2464|STANDARD_ERROR_OF_MEAN|0.19276||0.21|TWO_SIDED|95.0|-0.6381|0.1453|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1453|-0.6381|0.210
71766213|NCT00913458|143034219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.88||||0.0011|TWO_SIDED|95.0|2.4|33.1|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||33.1|2.4|0.0011
71711876|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3059|STANDARD_ERROR_OF_MEAN|0.14253||0.039|TWO_SIDED|95.0|-0.5955|-0.0162|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0162|-0.5955|0.039
71655923|NCT00899470|142830238|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.|Geometric Mean Ratio, Test vs. Reference|1.034|||||TWO_SIDED|90.0|0.962|1.111|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.111|0.962|
71655924|NCT00899470|142830239|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.024|||||TWO_SIDED|90.0|0.964|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.964|
71655925|NCT00899470|142830239|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.981|1.108|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(0-T)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.108|0.981|
71655926|NCT00899470|142830240|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||TWO_SIDED|90.0|0.973|1.088|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.088|0.973|
71655927|NCT00899470|142830240|NON_INFERIORITY_OR_EQUIVALENCE|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||TWO_SIDED|90.0|0.986|1.102|||Mixed Models Analysis|Bioequivalence=90% CIs for the test|For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log\[AUC(INF)\] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.||1.102|0.986|
71655928|NCT02192164|142830251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.757334|STANDARD_ERROR_OF_MEAN|1.594019|||TWO_SIDED|95.0|-5.916307|0.401638||||||||0.401638|-5.916307|
71655929|NCT02192164|142830252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.911449|STANDARD_ERROR_OF_MEAN|1.426517|||TWO_SIDED|95.0|-3.73847|1.915572||||||||1.915572|-3.73847|
71655930|NCT00359788|142830262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001|TWO_SIDED|95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
71655931|NCT00359788|142830263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.05 liters|Mean Difference (Final Values)|0.02||||0.0042||95.0|-0.032|0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.072|-0.032|0.0042
71655932|NCT00359788|142830264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
71655933|NCT00359788|142830265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||<|0.0001||95.0|-0.114|-0.046|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.046|-0.114|<0.0001
71827183|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 4 to Visit 5||||0.021
71827184|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 5 to Visit 6||||0.003
71766214|NCT00913458|143034219|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87||||0.0031|TWO_SIDED|95.0|1.7|13.9|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||13.9|1.7|0.0031
71766215|NCT00913458|143034220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.5951|TWO_SIDED|95.0|0.3|2.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|0.3|0.5951
71766216|NCT00913458|143034220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0934|TWO_SIDED|95.0|0.9|5.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.5|0.9|0.0934
71711877|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0134|STANDARD_ERROR_OF_MEAN|0.1538||0.931|TWO_SIDED|95.0|-0.2991|0.326|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3260|-0.2991|0.931
71711878|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1164|STANDARD_ERROR_OF_MEAN|0.14608||0.431|TWO_SIDED|95.0|-0.4133|0.1804|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1804|-0.4133|0.431
71711879|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3269|STANDARD_ERROR_OF_MEAN|0.13362||0.02|TWO_SIDED|95.0|-0.5985|-0.0554|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0554|-0.5985|0.020
71711880|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0845|STANDARD_ERROR_OF_MEAN|0.14418||0.562|TWO_SIDED|95.0|-0.3775|0.2085|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2085|-0.3775|0.562
71711881|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1727|STANDARD_ERROR_OF_MEAN|0.13695||0.216|TWO_SIDED|95.0|-0.451|0.1056|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1056|-0.4510|0.216
71711882|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0084|STANDARD_ERROR_OF_MEAN|0.17609||0.962|TWO_SIDED|95.0|-0.3663|0.3495|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3495|-0.3663|0.962
71711883|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0357|STANDARD_ERROR_OF_MEAN|0.19001||0.852|TWO_SIDED|95.0|-0.4218|0.3505|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3505|-0.4218|0.852
71711884|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2154|STANDARD_ERROR_OF_MEAN|0.18048||0.241|TWO_SIDED|95.0|-0.5822|0.1514|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1514|-0.5822|0.241
71766217|NCT00913458|143034220|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85||||0.0314|TWO_SIDED|95.0|1.1|7.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.4|1.1|0.0314
71766218|NCT00913458|143034221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6152|TWO_SIDED|95.0|0.5|2.8|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.8|0.5|0.6152
71766219|NCT00913458|143034221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0432|TWO_SIDED|95.0|1.0|5.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.4|1.0|0.0432
71766220|NCT00913458|143034221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1189|TWO_SIDED|95.0|0.8|4.3|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.3|0.8|0.1189
71766221|NCT00913458|143034222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0535|TWO_SIDED|95.0|1.0|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|1.0|0.0535
71827185|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.827|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 6 to Visit7||||0.827
71827186|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 7 to Visit 8||||0.093
71711885|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.17766||0.443|TWO_SIDED|95.0|-0.4991|0.223|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2230|-0.4991|0.443
71711886|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2037|STANDARD_ERROR_OF_MEAN|0.1917||0.295|TWO_SIDED|95.0|-0.5933|0.1859|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1859|-0.5933|0.295
71711887|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0602|STANDARD_ERROR_OF_MEAN|0.18209||0.743|TWO_SIDED|95.0|-0.4303|0.3098|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3098|-0.4303|0.743
71711888|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1774|STANDARD_ERROR_OF_MEAN|0.16068||0.277||95.0|-0.504|0.1491|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1491|-0.5040|0.277
71711889|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.17338||0.758|TWO_SIDED|95.0|-0.4062|0.2985|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2985|-0.4062|0.758
71711890|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4377|STANDARD_ERROR_OF_MEAN|0.16468||0.012|TWO_SIDED|95.0|-0.7724|-0.1031|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.1031|-0.7724|0.012
71711891|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1037|STANDARD_ERROR_OF_MEAN|0.14849||0.49|TWO_SIDED|95.0|-0.4055|0.1981|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1981|-0.4055|0.490
71711892|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1007|STANDARD_ERROR_OF_MEAN|0.16023||0.534|TWO_SIDED|95.0|-0.4263|0.2249|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2249|-0.4263|0.534
71711893|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.15219||0.169|TWO_SIDED|95.0|-0.5233|0.0953|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0953|-0.5233|0.169
71711894|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2641|STANDARD_ERROR_OF_MEAN|0.14118||0.07|TWO_SIDED|95.0|-0.551|0.0228|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0228|-0.5510|0.070
71711895|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0854|STANDARD_ERROR_OF_MEAN|0.15234||0.579|TWO_SIDED|95.0|-0.395|0.2242|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2242|-0.3950|0.579
71711896|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2446|STANDARD_ERROR_OF_MEAN|0.1447||0.1|TWO_SIDED|95.0|-0.5387|0.0494|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0494|-0.5387|0.100
71766222|NCT00913458|143034222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0064|TWO_SIDED|95.0|1.4|7.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.5|1.4|0.0064
71711897|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13533||0.113|TWO_SIDED|95.0|-0.495|0.055|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0550|-0.4950|0.113
71766223|NCT00913458|143034222|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.3696|TWO_SIDED|95.0|0.6|3.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.6|0.6|0.3696
71766224|NCT00913458|143034223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0788|TWO_SIDED|95.0|0.9|5.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||5.2|0.9|0.0788
71766225|NCT00913458|143034223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.0007|TWO_SIDED|95.0|1.9|11.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.0|1.9|0.0007
71766226|NCT00913458|143034223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0676|TWO_SIDED|95.0|0.9|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.7|0.9|0.0676
71711898|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0527|STANDARD_ERROR_OF_MEAN|0.14603||0.72|TWO_SIDED|95.0|-0.3495|0.244|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2440|-0.3495|0.720
71711899|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183|STANDARD_ERROR_OF_MEAN|0.1387||0.196|TWO_SIDED|95.0|-0.4649|0.0989|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0989|-0.4649|0.196
71711900|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2051|STANDARD_ERROR_OF_MEAN|0.20032||0.313|TWO_SIDED|95.0|-0.6122|0.202|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2020|-0.6122|0.313
71711901|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0253|STANDARD_ERROR_OF_MEAN|0.21616||0.908|TWO_SIDED|95.0|-0.414|0.4646|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4646|-0.4140|0.908
71711902|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3042|STANDARD_ERROR_OF_MEAN|0.20531||0.148|TWO_SIDED|95.0|-0.7214|0.1131|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1131|-0.7214|0.148
71711903|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3409|STANDARD_ERROR_OF_MEAN|0.17997||0.067|TWO_SIDED|95.0|-0.7066|0.0249|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0249|-0.7066|0.067
71711904|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0652|STANDARD_ERROR_OF_MEAN|0.19419||0.739|TWO_SIDED|95.0|-0.4599|0.3294|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3294|-0.4599|0.739
71711905|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4163|STANDARD_ERROR_OF_MEAN|0.18445||0.031|TWO_SIDED|95.0|-0.7912|-0.0415|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||-0.0415|-0.7912|0.031
71711906|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2032|STANDARD_ERROR_OF_MEAN|0.14369||0.166|TWO_SIDED|95.0|-0.4952|0.0888|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0888|-0.4952|0.166
71711907|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0932|STANDARD_ERROR_OF_MEAN|0.15504||0.552|TWO_SIDED|95.0|-0.2219|0.4083|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4083|-0.2219|0.552
71711908|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1648|STANDARD_ERROR_OF_MEAN|0.14727||0.271|TWO_SIDED|95.0|-0.4641|0.1345|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1345|-0.4641|0.271
71766227|NCT00913458|143034224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.56||||0.0548|TWO_SIDED|95.0|1.0|59.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||59.5|1.0|0.0548
71711909|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2516|STANDARD_ERROR_OF_MEAN|0.16169||0.129|TWO_SIDED|95.0|-0.5802|0.077|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0770|-0.5802|0.129
71827187|NCT01245439|143158798|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 8||||<0.001
71827188|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 1 to Visit 2||||0.792
71766228|NCT00913458|143034224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.18||||0.0166|TWO_SIDED|95.0|1.6|94.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||94.2|1.6|0.0166
71766229|NCT00913458|143034224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.3619|TWO_SIDED|95.0|0.6|4.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.5|0.6|0.3619
71766230|NCT00913458|143034225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23||||0.0017|TWO_SIDED|95.0|1.6|6.7|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.7|1.6|0.0017
71766231|NCT00913458|143034225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.05|||<|0.0001|TWO_SIDED|95.0|4.4|28.0|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||28.0|4.4|<0.0001
71766232|NCT00913458|143034225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42||||0.0111|TWO_SIDED|95.0|1.3|8.8|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||8.8|1.3|0.0111
71766233|NCT00913458|143034226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66||||0.0328|TWO_SIDED|95.0|-16.6|-0.7|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.7|-16.6|0.0328
71711910|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1279|STANDARD_ERROR_OF_MEAN|0.17447||0.468|TWO_SIDED|95.0|-0.2266|0.4825|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4825|-0.2266|0.468
71711911|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2033|STANDARD_ERROR_OF_MEAN|0.16572||0.228|TWO_SIDED|95.0|-0.5401|0.1334|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1334|-0.5401|0.228
71711912|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13268||0.141|TWO_SIDED|95.0|-0.4696|0.0696|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0696|-0.4696|0.141
71711913|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0065|STANDARD_ERROR_OF_MEAN|0.14317||0.964|TWO_SIDED|95.0|-0.2975|0.2844|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2844|-0.2975|0.964
71766234|NCT00913458|143034226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.64|||<|0.0001|TWO_SIDED|95.0|-30.1|-13.2|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-13.2|-30.1|<0.0001
71766235|NCT00913458|143034226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98||||0.0035|TWO_SIDED|95.0|-21.5|-4.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-4.5|-21.5|0.0035
71766236|NCT00913458|143034227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||0.2473|TWO_SIDED|95.0|-11.8|3.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||3.1|-11.8|0.2473
71766237|NCT00913458|143034227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.0016|TWO_SIDED|95.0|-21.3|-5.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-5.1|-21.3|0.0016
71766238|NCT00913458|143034227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.0348|TWO_SIDED|95.0|-17.0|-0.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.6|-17.0|0.0348
71766239|NCT00913458|143034228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.51||||0.1248|TWO_SIDED|95.0|-12.6|1.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.6|-12.6|0.1248
71766240|NCT00913458|143034228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.14||||0.0004|TWO_SIDED|95.0|-21.8|-6.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.5|-21.8|0.0004
71827189|NCT01245439|143158798|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 3||||<0.001
71711914|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1935|STANDARD_ERROR_OF_MEAN|0.13599||0.164|TWO_SIDED|95.0|-0.4699|0.0828|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0828|-0.4699|0.164
71711915|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1446|STANDARD_ERROR_OF_MEAN|0.13315||0.285|TWO_SIDED|95.0|-0.4152|0.126|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1260|-0.4152|0.285
71711916|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0176|STANDARD_ERROR_OF_MEAN|0.14368||0.903|TWO_SIDED|95.0|-0.3096|0.2744|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.2744|-0.3096|0.903
71711917|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1615|STANDARD_ERROR_OF_MEAN|0.13647||0.245|TWO_SIDED|95.0|-0.4388|0.1159|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1159|-0.4388|0.245
71711918|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3659|STANDARD_ERROR_OF_MEAN|0.45708||0.429|TWO_SIDED|95.0|-0.563|1.2948|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.2948|-0.5630|0.429
71711919|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0395|STANDARD_ERROR_OF_MEAN|0.49321||0.937|TWO_SIDED|95.0|-0.9628|1.0419|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.0419|-0.9628|0.937
71711920|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7902|STANDARD_ERROR_OF_MEAN|0.46847||0.101|TWO_SIDED|95.0|-0.1618|1.7423|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.7423|-0.1618|0.101
71711921|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4404|STANDARD_ERROR_OF_MEAN|0.43756||0.321|TWO_SIDED|95.0|-1.3296|0.4488|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4488|-1.3296|0.321
71711922|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4685|STANDARD_ERROR_OF_MEAN|0.47214||0.328|TWO_SIDED|95.0|-1.428|0.491|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.4910|-1.4280|0.328
71711923|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.44846||0.356|TWO_SIDED|95.0|-0.4914|1.3314|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||1.3314|-0.4914|0.356
71766241|NCT00913458|143034228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.63||||0.0306|TWO_SIDED|95.0|-16.4|-0.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-0.8|-16.4|0.0306
71766242|NCT00913458|143034229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.4717|TWO_SIDED|95.0|0.5|4.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.6|0.5|0.4717
71766243|NCT00913458|143034229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.0551|TWO_SIDED|95.0|1.0|7.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||7.8|1.0|0.0551
71766244|NCT00913458|143034229|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.2141|TWO_SIDED|95.0|0.7|4.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||4.8|0.7|0.2141
71766245|NCT00913458|143034231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9652|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.4|-0.5|0.9652
71827190|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 3 to Visit 4||||0.002
71827191|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 4 to Visit 5||||0.374
71827192|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 5 to Visit 6||||0.518
71827193|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 6 to Visit 7||||0.744
71711924|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2254|STANDARD_ERROR_OF_MEAN|0.1679||0.188|TWO_SIDED|95.0|-0.5666|0.1158|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1158|-0.5666|0.188
71711925|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0232|STANDARD_ERROR_OF_MEAN|0.18117||0.899|TWO_SIDED|95.0|-0.3914|0.3449|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3449|-0.3914|0.899
71711926|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2534|STANDARD_ERROR_OF_MEAN|0.17208||0.15|TWO_SIDED|95.0|-0.6032|0.0963|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0963|-0.6032|0.150
71711927|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2821|STANDARD_ERROR_OF_MEAN|0.19038||0.148|TWO_SIDED|95.0|-0.669|0.1048|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.1048|-0.6690|0.148
71711928|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.048|STANDARD_ERROR_OF_MEAN|0.20543||0.817|TWO_SIDED|95.0|-0.4655|0.3695|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.3695|-0.4655|0.817
71711929|NCT01892189|142940611|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3395|STANDARD_ERROR_OF_MEAN|0.19513||0.091|TWO_SIDED|95.0|-0.7361|0.057|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.||0.0570|-0.7361|0.091
71711930|NCT03322566|142940645|SUPERIORITY||Difference in Percentages|-18.5||||0.9948|TWO_SIDED|95.0|-32.0|-4.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen method||Stratified by PD-L1 TPS ( \<50% vs. \>=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata 'TPS \>= 50 percent Non-squamous' and 'TPS \>= 50% Squamous' were combined into one stratum.|||-4.3|-32.0|0.9948
71711931|NCT03322566|142940646|OTHER||Hazard Ratio (HR)|1.47||||0.94305|TWO_SIDED|95.0|0.91|2.36||One-sided p-value based on log-rank test stratified by TPS (\<50% vs \>=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata 'TPS \>= 50% Non-squamous' and 'TPS \>= 50% Squamous' were combined into one.|Regression, Cox|Efron's method of tie handling||||2.36|0.91|0.94305
71711932|NCT03322566|142940647|OTHER||Hazard Ratio (HR)|1.9||||0.96272|TWO_SIDED|95.0|0.93|3.9||One-sided p-value based on log-rank test stratified by PD-L1 TPS (\<50% vs \>=50%) and predominant tumor histology (squamous vs non-squamous), because of small sample size, the strata (\<50% vs \>=50%) were combined into one stratum.|Regression, Cox|||||3.90|0.93|0.96272
71711933|NCT05870345|142940658|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
71711934|NCT05870345|142940659|OTHER|Sample size too small to perform additional statistical tests.|||||||||||||||||Sample size too small to perform additional statistical tests.|||
71711935|NCT00376558|142940660|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
71711936|NCT00376558|142940661|SUPERIORITY_OR_OTHER||delta bpnd|-12.0|STANDARD_DEVIATION|7.0||0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.||||0.001
71711937|NCT02546323|142940662|OTHER||Estimated mean difference|-0.0103|STANDARD_ERROR_OF_MEAN|0.00445||0.02|TWO_SIDED|95.0|-0.0191|-0.0016||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0016|-0.0191|0.020
71711938|NCT02546323|142940663|OTHER||Estimated mean difference|-0.011|STANDARD_ERROR_OF_MEAN|0.00442||0.013|TWO_SIDED|95.0|-0.0197|-0.0024||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||-0.0024|-0.0197|0.013
71711939|NCT02546323|142940664|OTHER||Estimated mean difference|-0.0162|STANDARD_ERROR_OF_MEAN|0.00903||0.073|TWO_SIDED|95.0|-0.0339|0.0015||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0015|-0.0339|0.073
71766246|NCT00913458|143034231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2168|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2168
71711940|NCT02546323|142940665|OTHER||Estimated mean difference|-0.0043|STANDARD_ERROR_OF_MEAN|0.00716||0.547|TWO_SIDED|95.0|-0.0183|0.0097||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.||0.0097|-0.0183|0.547
71711941|NCT02546323|142940666|OTHER||Estimated mean difference|-0.0086|STANDARD_ERROR_OF_MEAN|0.00272||0.002|TWO_SIDED|95.0|-0.0139|-0.0032||Statistical significance of the MeanMean CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients|Comparison of annualized rate of change in MeanMean CIMT measurement difference between rosuvastatin 20 mg and placebo||-0.0032|-0.0139|0.002
71711942|NCT02546323|142940667|OTHER||Least squares mean difference|-35.46|STANDARD_ERROR_OF_MEAN|2.426|<|0.001|TWO_SIDED|95.0|-40.23|-30.7|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-30.70|-40.23|<0.001
71827194|NCT01245439|143158798|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 7 to Visit 8||||0.048
71655934|NCT00359788|142830266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054||||0.0447||95.0|0.001|0.106|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.106|0.001|0.0447
71655935|NCT00359788|142830267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.131|||<|0.0001||95.0|-0.171|-0.092|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.092|-0.171|<0.0001
71655936|NCT00359788|142830268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.152|||<|0.0001||95.0|-0.19|-0.113|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.113|-0.19|<0.0001
71655937|NCT00359788|142830269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||<|0.0001||95.0|-0.175|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.175|<0.0001
71655938|NCT00359788|142830270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
71655939|NCT00359788|142830271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.835||95.0|-0.092|0.114|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.114|-0.092|0.835
71711943|NCT02546323|142940667|OTHER||Least squares mean difference|-21.85|STANDARD_ERROR_OF_MEAN|1.441|<|0.001|TWO_SIDED|95.0|-24.68|-19.02|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-19.02|-24.68|<0.001
71711944|NCT02546323|142940667|OTHER||Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|1.347|<|0.001|TWO_SIDED|95.0|2.35|7.64|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||7.64|2.35|<0.001
71711945|NCT02546323|142940667|OTHER||Least squares mean difference|-19.65|STANDARD_ERROR_OF_MEAN|3.671|<|0.001|TWO_SIDED|95.0|-26.86|-12.44|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.44|-26.86|<0.001
71711946|NCT02546323|142940667|OTHER||Least squares mean difference|-29.49|STANDARD_ERROR_OF_MEAN|1.917|<|0.001|TWO_SIDED|95.0|-33.25|-25.72|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-25.72|-33.25|<0.001
71711947|NCT02546323|142940667|OTHER||Least squares mean difference|-31.75|STANDARD_ERROR_OF_MEAN|2.334|<|0.001|TWO_SIDED|95.0|-36.33|-27.16|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-27.16|-36.33|<0.001
71711948|NCT02546323|142940667|OTHER||Least squares mean difference|-26.12|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-29.73|-22.5|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB||-22.50|-29.73|<0.001
71711949|NCT02546323|142940667|OTHER||Least squares mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.104||0.047|TWO_SIDED|95.0|0.02|4.36|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate|Treatment difference (rosuvastatin 20 mg - placebo): ApoA-I||4.36|0.02|0.047
71711950|NCT02546323|142940667|OTHER||Least squares mean difference|-26.77|STANDARD_ERROR_OF_MEAN|2.041|<|0.001|TWO_SIDED|95.0|-30.78|-22.76|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB/ApoA-I ratio||-22.76|-30.78|<0.001
71711951|NCT02546323|142940668|OTHER||Least squares mean difference|-39.51|STANDARD_ERROR_OF_MEAN|1.819|<|0.001|TWO_SIDED|95.0|-43.08|-35.94|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C||-35.94|-43.08|<0.001
71711952|NCT02546323|142940668|OTHER||Least squares mean difference|-25.46|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-27.7|-23.23|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol||-23.23|-27.70|<0.001
71711953|NCT02546323|142940668|OTHER||Least squares mean difference|3.67|STANDARD_ERROR_OF_MEAN|1.051|<|0.001|TWO_SIDED|95.0|1.6|5.73|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C||5.73|1.60|<0.001
71711954|NCT02546323|142940668|OTHER||Least squares mean difference|-18.41|STANDARD_ERROR_OF_MEAN|2.981|<|0.001|TWO_SIDED|95.0|-24.26|-12.55|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides||-12.55|-24.26|<0.001
71711955|NCT02546323|142940668|OTHER||Least squares mean difference|-33.78|STANDARD_ERROR_OF_MEAN|1.529|<|0.001|TWO_SIDED|95.0|-36.78|-30.78|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C||-30.78|-36.78|<0.001
71827195|NCT01245439|143158798|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 8||||<0.001
71827196|NCT01245439|143158799|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 3||||<0.001
71827197|NCT01245439|143158799|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 3 to Visit 4||||<0.001
71827198|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 4 to Visit 5||||0.075
71711956|NCT02546323|142940668|OTHER||Least squares mean difference|-33.93|STANDARD_ERROR_OF_MEAN|1.836|<|0.001|TWO_SIDED|95.0|-37.54|-30.32|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio||-30.32|-37.54|<0.001
71711957|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0129|TWO_SIDED|95.0|2.41|14.72||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Left eye||14.72|2.41|0.0129
71711958|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|7.58||||0.0077|TWO_SIDED|95.0|1.7|13.45||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Foreign body sensation - Right eye||13.45|1.70|0.0077
71711959|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|3.99||||0.1589|TWO_SIDED|95.0|-1.64|9.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Left eye||9.62|-1.64|0.1589
71711960|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.3167|TWO_SIDED|95.0|-2.78|8.35||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Burning/ Stinging - Right eye||8.35|-2.78|0.3167
71711961|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.5243|TWO_SIDED|95.0|-7.64|3.96||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Left eye||3.96|-7.64|0.5243
71711962|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.6714|TWO_SIDED|95.0|-4.45|6.82||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Itching - Right eye||6.82|-4.45|0.6714
71711963|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|-3.89||||0.0828|TWO_SIDED|95.0|-8.31|0.53||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Left eye||0.53|-8.31|0.0828
71711964|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.7823|TWO_SIDED|95.0|-4.77|3.62||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Pain - Right eye||3.62|-4.77|0.7823
71711965|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.0432|TWO_SIDED|95.0|0.16|9.7||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Left eye||9.70|0.16|0.0432
71711966|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|6.35||||0.0088|TWO_SIDED|95.0|1.7|11.0||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Sticky feeling - Right eye||11.00|1.70|0.0088
71711967|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|9.28||||0.0013|TWO_SIDED|95.0|3.9|14.66||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Left eye||14.66|3.90|0.0013
71827199|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 5 to Visit 6||||0.119
71827200|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 6 to Visit 7||||0.007
71827201|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 7 to Visit 8||||0.047
71827202|NCT01245439|143158799|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 8||||<0.001
71827203|NCT01245439|143158799|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 3||||<0.001
71827204|NCT01245439|143158799|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 3 to Visit 4||||<0.001
71827205|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 4 to Visit 5||||0.001
71827206|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 5 to Visit 6||||0.084
71827207|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 6 to Visit 7||||0.272
71827208|NCT01245439|143158799|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 7 to Visit 8||||0.020
71827209|NCT01245439|143158799|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 8||||<0.001
71827210|NCT01245439|143158800|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
71766247|NCT00913458|143034231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.2131|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.0|-1.0|0.2131
71827211|NCT01245439|143158800|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||<0.001
71827212|NCT01245439|143158800|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.254
71827213|NCT01245439|143158800|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.138
71827214|NCT01245439|143158800|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.002
71827215|NCT01245439|143158800|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.104
71827216|NCT01245439|143158800|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 8||||<0.001
71827217|NCT01245439|143158801|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3||||<0.001
71827218|NCT01245439|143158801|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4||||0.002
71827219|NCT01245439|143158801|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5||||0.078
71827220|NCT01245439|143158801|SUPERIORITY_OR_OTHER|||||||0.349|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6||||0.349
71827221|NCT01245439|143158801|SUPERIORITY_OR_OTHER|||||||0.722|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7||||0.722
71827222|NCT01245439|143158801|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8||||0.224
71655940|NCT00359788|142830272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
71655941|NCT00359788|142830273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.157|||<|0.0001||95.0|-0.236|-0.078|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.078|-0.236|<0.0001
71655942|NCT00359788|142830274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.4386||95.0|-0.059|0.137|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.137|-0.059|0.4386
71655943|NCT00359788|142830275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282||||0.0001||95.0|-0.374|-0.191|||ANCOVA|||||-0.191|-0.374|0.0001
71655944|NCT00359788|142830276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361|||<|0.0001||95.0|-0.449|-0.274|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.274|-0.449|<0.0001
71655945|NCT00359788|142830277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|||<|0.0001||95.0|-0.375|-0.196|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.196|-0.375|<0.0001
71655946|NCT00359788|142830278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175|||<|0.0001||95.0|-0.207|-0.142|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.142|-0.207|<0.0001
71655947|NCT00359788|142830279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|||<|0.0001||95.0|-0.205|-0.131|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.131|-0.205|<0.0001
71655948|NCT00359788|142830280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|||<|0.0001||95.0|-0.221|-0.143|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.143|-0.221|<0.0001
71655949|NCT00359788|142830281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||<|0.0001||95.0|-0.175|-0.097|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.097|-0.175|<0.0001
71655950|NCT00359788|142830282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||<|0.0001||95.0|-0.125|-0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.044|-0.125|<0.0001
71655951|NCT00359788|142830283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.0997||95.0|-0.076|0.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.007|-0.076|0.0997
71655952|NCT00359788|142830284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.101||95.0|-0.007|0.08|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.08|-0.007|0.101
71655953|NCT00359788|142830285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.193|0.098|<0.0001
71655954|NCT00359788|142830286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055||||0.0411||95.0|-0.108|-0.002|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.002|-0.108|0.0411
71655955|NCT00359788|142830287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.0354||95.0|-0.116|-0.004|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.004|-0.116|0.0354
71655956|NCT00359788|142830288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.062||||0.041||95.0|-0.121|-0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.003|-0.121|0.041
71655957|NCT00359788|142830289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.5387||95.0|-0.076|0.04|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.04|-0.076|0.5387
71655958|NCT00359788|142830290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.0372||95.0|0.004|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|0.004|0.0372
71655959|NCT00359788|142830291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.0001||95.0|0.066|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|0.066|<0.0001
71711968|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|5.31||||0.00629|TWO_SIDED|95.0|-0.3|10.92||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Blurred vision - Right eye||10.92|-0.30|0.00629
71711969|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|9.92||||0.002|TWO_SIDED|95.0|3.89|15.95||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Left eye||15.95|3.89|0.0020
71711970|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|7.95||||0.0111|TWO_SIDED|95.0|1.93|13.97||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Photophobia - Right eye||13.97|1.93|0.0111
71711971|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|31.67||||0.0448|TWO_SIDED|95.0|0.78|62.56||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Left eye||62.56|0.78|0.0448
71711972|NCT02507934|142940674|SUPERIORITY||Mean Difference (Final Values)|26.36||||0.0834|TWO_SIDED|95.0|-3.66|56.37||For each parameter, for each eye, an ANOVA model for repeated measures has been used by including each available timepoint. The estimated mean difference between treatments (Vismed-Lubricin) over time has been reported and tested.|repeated measures ANOVA|||Analysis of variance for repeated measures on Total score ocular tolerability - Right eye||56.37|-3.66|0.0834
71711973|NCT02507934|142940676|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.2317|TWO_SIDED|95.0|-0.14|0.57|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 7 ±1||0.57|-0.14|0.2317
71711974|NCT02507934|142940676|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.6017|TWO_SIDED|95.0|-0.7|0.41|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 7 ±1||0.41|-0.70|0.6017
71711975|NCT02507934|142940676|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.0232|TWO_SIDED|95.0|0.11|1.36|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 14 ±1||1.36|0.11|0.0232
71711976|NCT02507934|142940676|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.0398|TWO_SIDED|95.0|0.03|1.17|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Right eye - Day 14 ±1||1.17|0.03|0.0398
71711977|NCT02507934|142940676|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.0038|TWO_SIDED|95.0|0.36|1.74|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - Left eye - Day 21 ±1||1.74|0.36|0.0038
71711978|NCT02507934|142940676|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.0135|TWO_SIDED|95.0|0.17|1.33|||Student t-test for unpaired data|||T-test on changes from baseline on corneal fluorescein surface staining - right eye||1.33|0.17|0.0135
71711979|NCT02507934|142940677|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.3442|TWO_SIDED|95.0|-0.66|1.83|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 7±1||1.83|-0.66|0.3442
71711980|NCT02507934|142940677|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.772|TWO_SIDED|95.0|-1.99|1.49|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 7±1||1.49|-1.99|0.7720
71711981|NCT02507934|142940677|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9725|TWO_SIDED|95.0|-1.49|1.44|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 14±1||1.44|-1.49|0.9725
71711982|NCT02507934|142940677|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.2111|TWO_SIDED|95.0|-3.54|0.81|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - Day 14±1||0.81|-3.54|0.2111
71711983|NCT02507934|142940677|SUPERIORITY||Median Difference (Final Values)|-1.1||||0.2629|TWO_SIDED|90.0|-3.06|0.86|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Left eye - Day 21±1||0.86|-3.06|0.2629
71711984|NCT02507934|142940677|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.2862|TWO_SIDED|95.0|-3.6|1.1|||Student t-test for unpaired data|||T-test on changes from baseline on Schirmer's test type I strip wetting distance - Right eye - 21±1||1.10|-3.60|0.2862
71711985|NCT02507934|142940678|SUPERIORITY||Mean Difference (Final Values)|11.24||||0.2075|TWO_SIDED|95.0|-6.66|29.14|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 7±1||29.14|-6.66|0.2075
71711986|NCT02507934|142940678|SUPERIORITY||Mean Difference (Final Values)|18.16||||0.0435|TWO_SIDED|95.0|0.57|35.76|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 14±1||35.76|0.57|0.0435
71711987|NCT02507934|142940678|SUPERIORITY||Mean Difference (Final Values)|23.58||||0.0133|TWO_SIDED|95.0|5.24|41.93|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Frequency - Day 21±1||41.93|5.24|0.0133
71711988|NCT02507934|142940679|SUPERIORITY||Mean Difference (Final Values)|4.36||||0.613|TWO_SIDED|95.0|-12.98|21.69|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 7±1||21.69|-12.98|0.6130
71711989|NCT02507934|142940679|SUPERIORITY||Mean Difference (Final Values)|12.7||||0.1047|TWO_SIDED|95.0|-2.78|28.18|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 14±1||28.18|-2.78|0.1047
71711990|NCT02507934|142940679|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.1108|TWO_SIDED|95.0|-3.24|30.04|||Student t-test for unpaired data|||T-test on changes from baseline in symptom assessment in dry eye - Severity - Day 21±1||30.04|-3.24|0.1108
71711991|NCT02507934|142940680|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.498|TWO_SIDED|95.0|-0.4|0.81|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 7±1||0.81|-0.40|0.4980
71711992|NCT02507934|142940680|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.1986|TWO_SIDED|95.0|-0.18|0.83|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 7±1||0.83|-0.18|0.1986
71711993|NCT02507934|142940680|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4067|TWO_SIDED|95.0|-0.9|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 14±1||0.37|-0.90|0.4067
71711994|NCT02507934|142940680|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.5256|TWO_SIDED|95.0|-0.81|0.42|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 14±1||0.42|-0.81|0.5256
71711995|NCT02507934|142940680|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.1471|TWO_SIDED|95.0|-1.12|0.17|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Left eye - Day 21±1||0.17|-1.12|0.1471
71711996|NCT02507934|142940680|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.2455|TWO_SIDED|95.0|-0.96|0.25|||Student t-test for unpaired data|||T-test on changes from baseline in Ocular Protection Index - Right eye - Day 21±1||0.25|-0.96|0.2455
71711997|NCT02507934|142940681|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.4233|TWO_SIDED|95.0|-1.98|0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 7±1||0.85|-1.98|0.4233
71711998|NCT02507934|142940681|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.6335|TWO_SIDED|95.0|-1.04|1.69|||Student t-test for unpaired data|||T test p-value - Right eye - Day 7±1||1.69|-1.04|0.6335
71711999|NCT02507934|142940681|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.0103|TWO_SIDED|95.0|-3.56|-0.51|||Student t-test for unpaired data|||T test p-value - Left eye - Day 14±1||-0.51|-3.56|0.0103
71712000|NCT02507934|142940681|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.1006|TWO_SIDED|95.0|-2.95|0.27|||Student t-test for unpaired data|||T test p-value - Right eye - Day 14±1||0.27|-2.95|0.1006
71712001|NCT02507934|142940681|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0041|TWO_SIDED|95.0|-4.15|-0.85|||Student t-test for unpaired data|||T test p-value - Left eye - Day 21±1||-0.85|-4.15|0.0041
71712002|NCT02507934|142940681|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.0429|TWO_SIDED|95.0|-3.67|-0.06|||Student t-test for unpaired data|||T test p-value - Right eye - Day 21±1||-0.06|-3.67|0.0429
71712003|NCT02507934|142940682|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2338|TWO_SIDED|95.0|-0.75|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 7±1||0.19|-0.75|0.2338
71712004|NCT02507934|142940682|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.3081|TWO_SIDED|95.0|-0.58|0.19|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 7±1||0.19|-0.58|0.3081
71712005|NCT02507934|142940682|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.4287|TWO_SIDED|95.0|-2.57|5.74|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 14±1||5.74|-2.57|0.4287
71712006|NCT02507934|142940682|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.5765|TWO_SIDED|95.0|-3.14|5.44|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 14±1||5.44|-3.14|0.5765
71712007|NCT02507934|142940682|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.0259|TWO_SIDED|95.0|-2.18|-0.15|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Left eye - Day 21±1||-0.15|-2.18|0.0259
71712008|NCT02507934|142940682|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.1496|TWO_SIDED|95.0|-2.23|0.37|||Student t-test for unpaired data|||T-test on changes from baseline in Visual acuity score - Right eye - Day 21±1||0.37|-2.23|0.1496
71712009|NCT02507934|142940683|SUPERIORITY|||||||0.2342|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 7±1||||0.2342
71712010|NCT02507934|142940683|SUPERIORITY|||||||0.8874|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 7±1||||0.8874
71712011|NCT02507934|142940683|SUPERIORITY|||||||0.0504|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 7±1||||0.0504
71712012|NCT02507934|142940683|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 7±1||||0.0814
71712013|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 7±1||||1.0000
71712014|NCT02507934|142940683|SUPERIORITY|||||||0.3855|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 7±1||||0.3855
71712015|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 7±1||||1.0000
71712016|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 7±1||||1.0000
71712017|NCT02507934|142940683|SUPERIORITY|||||||0.4754|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 7±1||||0.4754
71712018|NCT02507934|142940683|SUPERIORITY|||||||0.2914|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 7±1||||0.2914
71712019|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 7±1||||1.0000
71712020|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 7±1||||1.0000
71712021|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 7±1||||1.0000
71712022|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 7±1||||1.0000
71712023|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 7±1||||1.0000
71827223|NCT04495634|143158813|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.|||||<|0.0001|||||||ANOVA|||||||<0.0001
71712024|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 7±1||||1.0000
71712025|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 7±1||||1.0000
71712026|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 7±1||||1.0000
71712027|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 7±1||||1.0000
71712028|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 7±1||||1.0000
71712029|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 7±1||||1.0000
71712030|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 7±1||||1.0000
71712031|NCT02507934|142940683|SUPERIORITY|||||||0.2429|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 14±1||||0.2429
71712032|NCT02507934|142940683|SUPERIORITY|||||||0.5707|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 14±1||||0.5707
71712033|NCT02507934|142940683|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 14±1||||0.0092
71712034|NCT02507934|142940683|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Left - Day 14±1||||0.0039
71712035|NCT02507934|142940683|SUPERIORITY|||||||0.2882|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 14±1||||0.2882
71712036|NCT02507934|142940683|SUPERIORITY|||||||0.4017|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 14±1||||0.4017
71712037|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 14±1||||1.0000
71712038|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 14±1||||1.0000
71712039|NCT02507934|142940683|SUPERIORITY|||||||0.0731|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 14±1||||0.0731
71712040|NCT02507934|142940683|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 14±1||||0.0020
71712041|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 14±1||||1.0000
71712042|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 14±1||||1.0000
71712043|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 14±1||||1.0000
71712044|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 14±1||||1.0000
71712045|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 14±1||||1.0000
71712046|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 14±1||||1.0000
71712047|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 14±1||||1.0000
71712048|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 14±1||||1.0000
71712049|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 14±1||||1.0000
71712050|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 14±1||||1.0000
71712051|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 14±1||||1.0000
71712052|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 14±1||||1.0000
71712053|NCT02507934|142940683|SUPERIORITY|||||||0.1376|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Right - Day 21±1||||0.1376
71712054|NCT02507934|142940683|SUPERIORITY|||||||0.3252|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Meibomian Glands - Left - Day 21±1||||0.3252
71712055|NCT02507934|142940683|SUPERIORITY|||||||0.0111|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0111
71827224|NCT04495634|143158814|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.41|||||||ANOVA|||||||0.41
71827225|NCT04495634|143158815|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
71712056|NCT02507934|142940683|SUPERIORITY|||||||0.0049|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Erythema - Right - Day 21±1||||0.0049
71712057|NCT02507934|142940683|SUPERIORITY|||||||0.1178|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Right - Day 21±1||||0.1178
71712058|NCT02507934|142940683|SUPERIORITY|||||||0.9042|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Eyelid - Oedema - Left - Day 21±1||||0.9042
71712059|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Right - Day 21±1||||1.0000
71712060|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lashes - Left - Day 21±1||||1.0000
71712061|NCT02507934|142940683|SUPERIORITY|||||||0.0253|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Right - Day 21±1||||0.0253
71712062|NCT02507934|142940683|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Erythema - Left - Day 21±1||||0.0016
71766248|NCT00913458|143034233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.9338|TWO_SIDED|95.0|-10.0|10.9|||ANCOVA||Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.|Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.9|-10.0|0.9338
71827226|NCT04495634|143158816|EQUIVALENCE|The equivalence margin was defined through power calculations based on sample size, power of 0.90 and alpha of 0.05 resulting in a margin of +/- 0.26.||||||0.0001|||||||ANOVA|||||||0.0001
71712063|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Right - Day 21±1||||1.0000
71712064|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Conjunctiva - Oedema - Left - Day 21±1||||1.0000
71712065|NCT02507934|142940683|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Right - Day 21±1||||0.3165
71712066|NCT02507934|142940683|SUPERIORITY|||||||0.3165|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Lens - Left - Day 21±1||||0.3165
71712067|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Right - Day 21±1||||1.0000
71712068|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Iris - Left - Day 21±1||||1.0000
71712069|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Right - Day 21±1||||1.0000
71712070|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Anterior chamber inflammation - Left - Day 21±1||||1.0000
71712071|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Right - Day 21±1||||1.0000
71712072|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea transparency - Left - Day 21±1||||1.0000
71712073|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Right - Day 21±1||||1.0000
71712074|NCT02507934|142940683|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in slit lamp examination scores - Cornea neovascularization - Left - Day 21±1||||1.0000
71712075|NCT02507934|142940684|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0599|TWO_SIDED|95.0|-0.05|2.29|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 7±1||2.29|-0.05|0.0599
71712076|NCT02507934|142940684|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.3969|TWO_SIDED|95.0|-0.68|1.66|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 7±1||1.66|-0.68|0.3969
71712077|NCT02507934|142940684|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.7225|TWO_SIDED|95.0|-1.29|1.84|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 14±1||1.84|-1.29|0.7225
71712078|NCT02507934|142940684|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.269|TWO_SIDED|95.0|-2.14|0.62|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye - Day 14±1||0.62|-2.14|0.2690
71712079|NCT02507934|142940684|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.2344|TWO_SIDED|95.0|-0.53|2.1|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Left eye - Day 21±1||2.10|-0.53|0.2344
71712080|NCT02507934|142940684|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.5953|TWO_SIDED|95.0|-1.3|2.24|||Student t-test for unpaired data|||T-test on changes from baseline in Intraocular pressure - Right eye||2.24|-1.30|0.5953
71712081|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.2193|TWO_SIDED|95.0|-0.54|2.11|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 7||2.11|-0.54|0.2193
71827227|NCT05298111|143158912|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71827228|NCT05298111|143158913|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||< 0.001
71827229|NCT05298111|143158914|SUPERIORITY||||||<|0.001|||||||Sign test|||||||< 0.001
71827230|NCT05298111|143158915|SUPERIORITY|||||||0.001|||||||Sign test|||||||0.001
71827231|NCT05298111|143158916|SUPERIORITY|||||||0.894|||||||Paired t-test|||||||0.894
71712082|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.0024|TWO_SIDED|95.0|0.51|2.18|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 8||2.18|0.51|0.0024
71712083|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.425|TWO_SIDED|95.0|-0.49|1.14|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 9||1.14|-0.49|0.4250
71712084|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.1275|TWO_SIDED|95.0|-0.17|1.29|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 10||1.29|-0.17|0.1275
71712085|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.0844|TWO_SIDED|95.0|-0.09|1.42|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 11||1.42|-0.09|0.0844
71712086|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.0238|TWO_SIDED|95.0|0.12|1.6|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 12||1.60|0.12|0.0238
71712087|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.0369|TWO_SIDED|95.0|0.05|1.61|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 13||1.61|0.05|0.0369
71712088|NCT02507934|142940685|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.3496|TWO_SIDED|95.0|-0.61|1.64|||Student t-test for unpaired data|||T-test on number of daily administrations of IMD during the second week of the clinical investigation - Day 14||1.64|-0.61|0.3496
71712089|NCT01506726|142940730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.23|TWO_SIDED|95.0|-2.08|0.2|||Wilcoxon (Mann-Whitney)|Wilcoxon two sample test||||0.20|-2.08|0.230
71712090|NCT01506726|142940731|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||t-test, 2 sided|||||||0.347
71712091|NCT01506726|142940732|SUPERIORITY_OR_OTHER|||||||0.857|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.857
71712092|NCT01506726|142940732|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||Correlation between change in IL-6 and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.706
71712093|NCT01506726|142940732|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.014
71712094|NCT01506726|142940732|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED|||||Correlation between change in TNF and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.136
71712095|NCT01506726|142940732|SUPERIORITY_OR_OTHER|||||||0.803|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.803
71712096|NCT01506726|142940732|SUPERIORITY_OR_OTHER|||||||0.894|TWO_SIDED|||||Correlation between change in CRP and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.894
71712097|NCT01506726|142940733|SUPERIORITY_OR_OTHER|||||||0.143|TWO_SIDED|||||P value comparing change in IL6 between treatment groups.|t-test, 2 sided|||||||0.143
71712098|NCT01506726|142940733|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED|||||P value comparing the change in TNF between treatment groups.|t-test, 2 sided|||||||0.257
71712099|NCT01506726|142940734|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED|||||P-value comparing the change in EPO between treatment groups.|t-test, 2 sided|||||||0.535
71712100|NCT01506726|142940735|SUPERIORITY_OR_OTHER|||||||0.232|TWO_SIDED||||||t-test, 2 sided|||||||0.232
71712101|NCT01506726|142940736|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED||||||t-test, 2 sided|||||||0.076
71712102|NCT01506726|142940737|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
71712103|NCT01506726|142940738|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||t-test, 2 sided|||||||0.187
71827232|NCT05298111|143158917|SUPERIORITY|||||||0.629|||||||Paired t-test|||||||0.629
71712104|NCT01506726|142940739|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
71712105|NCT01506726|142940740|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||t-test, 2 sided|||||||0.619
71712106|NCT01506726|142940741|SUPERIORITY_OR_OTHER|||||||0.642|TWO_SIDED||||||t-test, 2 sided|||||||0.642
71712107|NCT01506726|142940742|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||||||0.42
71712108|NCT01506726|142940743|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
71712109|NCT01506726|142940744|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Chi-squared|||||||0.375
71712110|NCT01506726|142940746|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
71712111|NCT01506726|142940747|SUPERIORITY_OR_OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
71712112|NCT03863574|142940748|OTHER|Proof of Concept||||||0.7689|||||||t-test, 2 sided|||||||0.7689
71712113|NCT03863574|142940748|OTHER|Proof-of-concept||||||0.6007|||||||t-test, 2 sided|||||||0.6007
71712114|NCT03863574|142940749|OTHER|||||||0.5238|||||||Fisher Exact|||||||0.5238
71712115|NCT03863574|142940749|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71712116|NCT03863574|142940750|OTHER|Proof-of-concept||||||0.0476|||||||Fisher Exact|||||||0.0476
71712117|NCT03863574|142940750|OTHER|Proof-of-concept||||||0.0333|||||||Fisher Exact|||||||0.0333
71712118|NCT03863574|142940751|OTHER|Proof-of-concept||||||0.6845|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.6845
71712119|NCT03863574|142940751|OTHER|Proof-of-concept||||||0.4625|||||||t-test, 2 sided|||Outcome Variable: Steatosis||||0.4625
71712120|NCT03863574|142940751|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Lobular Inflammation||||0.1705
71712121|NCT03863574|142940751|OTHER|Proof-of-concept||||||0.3122|||||||t-test, 2 sided|||Outcome variable: Lobular Inflammation||||0.3122
71827233|NCT05298111|143158918|SUPERIORITY|||||||0.653|||||||Paired t-test|||||||0.653
71827234|NCT05298111|143158919|SUPERIORITY|||||||0.624|||||||Paired t-test|||||||0.624
71827235|NCT05298111|143158920|SUPERIORITY|||||||0.414|||||||Paired t-test|||||||0.414
71827236|NCT05298111|143158921|SUPERIORITY|||||||0.105|||||||Paired t-test|||||||0.105
71712122|NCT03863574|142940751|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.1705
71766249|NCT00913458|143034233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.713|TWO_SIDED|95.0|-16.4|11.2|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||11.2|-16.4|0.7130
71766250|NCT00913458|143034233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.6628|TWO_SIDED|95.0|-16.6|10.6|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||10.6|-16.6|0.6628
71712123|NCT03863574|142940751|OTHER|Proof-of-concept||||||0.3877|||||||t-test, 2 sided|||Outcome Variable: Hepatocyte Ballooning||||0.3877
71712124|NCT03863574|142940752|OTHER|Proof-of-concept||||||0.1705|||||||t-test, 2 sided|||||||0.1705
71712125|NCT03863574|142940752|OTHER|Proof-of-concept||||||0.174|||||||t-test, 2 sided|||||||0.1740
71712126|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.8019|||||||t-test, 2 sided|||Outcome variable: Alanine Aminotransferase||||0.8019
71712127|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.5396|||||||t-test, 2 sided|||Outcome Variable: Alanine Aminotransferase||||0.5396
71712128|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.774|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.7740
71712129|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.9221|||||||t-test, 2 sided|||Outcome Variable: Aspartate Aminotransferase||||0.9221
71712130|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.003|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0030
71712131|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.0177|||||||t-test, 2 sided|||Outcome Variable: Alkaline Phosphatase||||0.0177
71712132|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.1399|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.1399
71712133|NCT03863574|142940753|OTHER|Proof-of-concept||||||0.2384|||||||t-test, 2 sided|||Outcome Variable: Gamma Glutamyl Transferase||||0.2384
71712134|NCT03863574|142940754|OTHER|Proof-of-concept||||||0.2218|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.2218
71712135|NCT03863574|142940754|OTHER|Proof-of-Concept||||||0.1483|||||||t-test, 2 sided|||Outcome Variable: Albumin||||0.1483
71766251|NCT00913458|143034235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.74||||0.1303|TWO_SIDED|95.0|-15.5|2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||2.0|-15.5|0.1303
71712136|NCT03863574|142940754|OTHER|Proof-of-concept||||||0.0839|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.0839
71712137|NCT03863574|142940754|OTHER|Proof-of-concept||||||0.2895|||||||t-test, 2 sided|||Outcome Variable: Total Protein||||0.2895
71712138|NCT03863574|142940755|OTHER|Proof-of-concept||||||0.6808|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.6808
71712139|NCT03863574|142940755|OTHER|Proof-of-concept||||||0.5351|||||||t-test, 2 sided|||Outcome Variable: Direct Bilirubin||||0.5351
71712140|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.2329|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.2329
71712141|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.7211|||||||t-test, 2 sided|||Outcome Variable: Triglyceride||||0.7211
71712142|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.652|||||||t-test, 2 sided|||Outcome Variables: Total Cholesterol||||0.6520
71712143|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.4302|||||||t-test, 2 sided|||Outcome Variable: Total Cholesterol||||0.4302
71712144|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.9432|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.9432
71712145|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.2133|||||||t-test, 2 sided|||Outcome Variable: High-density Lipoprotein||||0.2133
71712146|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.2446|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.2446
71712147|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.7075|||||||t-test, 2 sided|||Outcome Variable: Low-density lipoprotein||||0.7075
71712148|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.2195|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.2195
71712149|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.7435|||||||t-test, 2 sided|||Outcome Variable: Very low-density lipoprotein||||0.7435
71712150|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.5702|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.5702
71712151|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.6441|||||||t-test, 2 sided|||Outcome Variable: non-HDL Cholesterol||||0.6441
71712152|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.8415|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.8415
71712153|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.0786|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein A1||||0.0786
71712154|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.8878|||||||t-test, 2 sided|||Outcome Variable: Apo lipoprotein B||||0.8878
71712155|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.3219|||||||t-test, 2 sided|||Outcome variable: Apo lipoprotein B||||0.3219
71712156|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.6557|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.6557
71712157|NCT03863574|142940756|OTHER|Proof-of-concept||||||0.0763|||||||t-test, 2 sided|||Outcome Variable: Small dense LDL||||0.0763
71712158|NCT03863574|142940758|OTHER|Proof-of-concept||||||0.6988|||||||t-test, 2 sided|||||||0.6988
71712159|NCT03863574|142940758|OTHER|Proof-of-concept||||||0.7413|||||||t-test, 2 sided|||||||0.7413
71712160|NCT03863574|142940759|OTHER|Proof-of-concept||||||0.22|||||||t-test, 2 sided|||||||0.2200
71712161|NCT03863574|142940759|OTHER|Proof-of-concept||||||0.5798|||||||t-test, 2 sided|||||||0.5798
71712162|NCT03863574|142940760|OTHER|Proof-of-concept||||||0.4981|||||||t-test, 2 sided|||||||0.4981
71712163|NCT03863574|142940760|OTHER|Proof-of-concept||||||0.8939|||||||t-test, 2 sided|||||||0.8939
71712164|NCT03863574|142940761|OTHER|Proof-of-concept||||||0.3605|||||||t-test, 2 sided|||||||0.3605
71712165|NCT03863574|142940761|OTHER|Proof-of-concept||||||0.8394|||||||t-test, 2 sided|||||||0.8394
71712166|NCT03863574|142940762|OTHER|Proof-of-concept||||||0.2665|||||||t-test, 2 sided|||||||0.2665
71827237|NCT02715258|143158949|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Analysis of change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
71827238|NCT02715258|143158949|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0021|TWO_SIDED|95.0|-0.68|-0.15||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.15|-0.68|0.0021
71827239|NCT02715258|143158949|SUPERIORITY||mixed-effects repeated measures|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|Mixed Models Analysis|||Sensitivity Analysis 2: Multiple imputation for change from baseline in HbA1c (%) excluding observations obtained after rescue medication||-0.30|-0.80|<0.0001
71712167|NCT03863574|142940762|OTHER|Proof-of-concept||||||0.9133|||||||t-test, 2 sided|||||||0.9133
71712168|NCT03863574|142940763|OTHER|Proof-of-concept||||||0.7267|||||||t-test, 2 sided|||||||0.7267
71712169|NCT03863574|142940763|OTHER|Proof-of-concept||||||0.9211|||||||t-test, 2 sided|||||||0.9211
71712170|NCT03863574|142940764|OTHER|Proof-of-concept||||||0.8683|||||||t-test, 2 sided|||||||0.8683
71712171|NCT03863574|142940764|OTHER|Proof-of-concept||||||0.7436|||||||t-test, 2 sided|||||||0.7436
71766252|NCT00913458|143034235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.59||||0.0024|TWO_SIDED|95.0|-27.1|-6.0|||Longitudinal statisitical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-6.0|-27.1|0.0024
71766253|NCT00913458|143034235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.85||||0.0621|TWO_SIDED|95.0|-20.2|0.5|||Longitudinal statistical model|||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||0.5|-20.2|0.0621
71827240|NCT02715258|143158949|SUPERIORITY||mixed-effects repeated measures|-0.4||||0.0009|TWO_SIDED|95.0|-0.64|-0.17||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in HbA1c (%) including observations obtained after rescue medication||-0.17|-0.64|0.0009
71827241|NCT02715258|143158950|SUPERIORITY||mixed-effects repeated measures|-2.14||||0.234|TWO_SIDED|95.0|-5.66|1.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in SBP (mm Hg) at Week 24||1.39|-5.66|0.2340
71827242|NCT02715258|143158950|SUPERIORITY||mixed-effects repeated measures|-1.91||||0.2937|TWO_SIDED|95.0|-5.48|1.66||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in SBP (mm Hg) including observations obtained after rescue medication||1.66|-5.48|0.2937
71827243|NCT02715258|143158950|SUPERIORITY||mixed-effects repeated measures|-1.72||||0.403|TWO_SIDED|95.0|-5.75|2.32||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in SBP (mm Hg) excluding observations obtained after rescue medication||2.32|-5.75|0.4030
71712172|NCT05081843|142940773|SUPERIORITY||Mean Difference (Final Values)|0.233||||0.05|TWO_SIDED|95.0|-0.056|0.522|||t-test, 2 sided|||||0.522|-0.056|0.05
71712173|NCT05081843|142940774|SUPERIORITY||Median Difference (Final Values)|0.534||||0.05|TWO_SIDED|95.0|0.078|0.99|||t-test, 2 sided|||||0.990|0.078|0.05
71712174|NCT05081843|142940775|SUPERIORITY||Mean Difference (Final Values)|0.326||||0.05|TWO_SIDED|95.0|-0.177|0.829|||t-test, 2 sided|||||0.829|-0.177|0.05
71712175|NCT05081843|142940776|SUPERIORITY||Mean Difference (Final Values)|0.756||||0.05|TWO_SIDED|95.0|0.208|1.31|||t-test, 2 sided|||||1.31|0.208|0.05
71712176|NCT02303821|142940783|OTHER||||||||||||||||||The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).|||
71712177|NCT02303821|142940784|OTHER||||||||||||||||||The objective of this endpoint was to compare EFS in study 20140106 with EFS in an external control arm selected from an observational study (Amgen 20180065). The median duration in months in the external control arm was 3.62 (95% CI: 1.55, 5.36) for B-cell participants, with a treatment difference hazard ration of 1.435 (95% CI: 0.976, 2.111). For T-Cell participants the median in months was 2.93 (95% CI: 0.95, 5.10) with a treatment difference hazard ratio of 1.404 (95% CI: 0.869, 2.270).|||
71712178|NCT02303821|142940785|OTHER||||||||||||||||||The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).|||
71712179|NCT02303821|142940786|OTHER||||||||||||||||||The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).|||
71827244|NCT02715258|143158950|SUPERIORITY||mixed-effects repeated measures|-2.09||||0.216|TWO_SIDED|95.0|-5.41|1.23||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||||1.23|-5.41|0.2160
71827245|NCT02715258|143158951|SUPERIORITY||mixed-effects repeated measures|-0.79||||0.1222|TWO_SIDED|95.0|-1.8|0.21||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in body weight (kg) at Week 24 for subjects with BMI greater than or equal to 25 kg/m2||0.21|-1.80|0.1222
71712180|NCT02303821|142940798|OTHER||||||||||||||||||The primary objective of this endpoint was to compare the percentage of participants achieving CR after the end of induction therapy in study 20140106 with the percentage of participants achieving CR in an external control arm selected from an observational study (Amgen 20180065). In the external control arm, 7.8% of B-Cell participants (95% confidence interval \[CI\]: 1.0%, 14.7%) achieved CR, with a treatment difference odds ratio of 2.04 (95% CI: 0.54, 7.66). For T-Cell participants, 9.1% (95% CI: 0.7%, 17.5%) achieved CR, with an odds ratio of 1.58 (95% CI: 0.47, 5.31).|||
71827246|NCT02715258|143158951|SUPERIORITY||mixed-effects repeated measures|-0.65||||0.2014|TWO_SIDED|95.0|-1.65|0.35||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 1: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.35|-1.65|0.2014
71827247|NCT02715258|143158951|SUPERIORITY||mixed-effects repeated measures|-0.91||||0.0638|TWO_SIDED|95.0|-1.88|0.05||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 2: Multiple imputation for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 excluding observations obtained after rescue medication||0.05|-1.88|0.0638
71827248|NCT02715258|143158951|SUPERIORITY||mixed-effects repeated measures|-0.69||||0.1456|TWO_SIDED|95.0|-1.63|0.24||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Sensitivity Analysis 3: LOCF for change from baseline in body weight (kg) for subjects with BMI greater than or equal to 25 kg/m2 including observations obtained after rescue medication||0.24|-1.63|0.1456
71827249|NCT02715258|143158952|SUPERIORITY||mixed-effects repeated measures|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.92|-1.09||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Analysis of change from baseline in FPG (mmol/L) over time across 24 weeks||-1.09|-1.92|<0.0001
71827250|NCT02715258|143158953|SUPERIORITY||mixed-effects repeated measures|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.79|-0.43||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 6||-0.43|-0.79|<0.0001
71827251|NCT02715258|143158953|SUPERIORITY||mixed-effects repeated measures|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.92|-0.5||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 12||-0.50|-0.92|<0.0001
71827252|NCT02715258|143158953|SUPERIORITY||mixed-effects repeated measures|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 18||-0.36|-0.78|<0.0001
71655960|NCT00359788|142830292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.108|0.216|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.216|0.108|<0.0001
71655961|NCT00359788|142830293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|||<|0.0001||95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.157|0.055|<0.0001
71655962|NCT00359788|142830294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0023||95.0|-0.136|-0.03|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.03|-0.136|0.0023
71712181|NCT04116489|142940805|SUPERIORITY|||||||0.5272|||||||Regression, Linear|||||||.5272
71712182|NCT04116489|142940806|SUPERIORITY|||||||0.1657|||||||Regression, Linear|||||||.1657
71712183|NCT04116489|142940807|SUPERIORITY|||||||0.2437|||||||Regression, Linear|||||||.2437
71712184|NCT04116489|142940808|OTHER|||||||0.0373|||||||Regression, Linear|||||||.0373
71712185|NCT01346592|142940855|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|2.44|||||TWO_SIDED|97.6|2.06|2.9||||||||2.9|2.06|
71712186|NCT01346592|142940855|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|1.89|||||TWO_SIDED|97.6|1.69|2.1||||||||2.1|1.69|
71712187|NCT01346592|142940855|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.07|||||TWO_SIDED|97.6|2.66|3.54||||||||3.54|2.66|
71712188|NCT01346592|142940855|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H1N1 strain)|3.2|||||TWO_SIDED|97.6|2.7|3.8||||||||3.8|2.7|
71712189|NCT01346592|142940855|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (H3N2 strain)|2.38|||||TWO_SIDED|97.6|2.14|2.65||||||||2.65|2.14|
71655963|NCT00359788|142830295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087||||0.0019||95.0|-0.142|-0.033|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.033|-0.142|0.0019
71712190|NCT01346592|142940855|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was \>0.667|GMT ratio (B strain)|3.14|||||TWO_SIDED|97.6|2.72|3.62||||||||3.62|2.72|
71712191|NCT01346592|142940856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%.|Group difference (H1N1 strain)|9.09|||||TWO_SIDED|97.6|5.48|12.69||||||||12.69|5.48|
71712192|NCT01346592|142940856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \>-10%|Group difference (H3N2 strain)|4.07|||||TWO_SIDED|97.6|1.58|6.55||||||||6.55|1.58|
71712193|NCT01346592|142940856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.82|||||TWO_SIDED|97.6|8.72|14.92||||||||14.92|8.72|
71712194|NCT01346592|142940856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|14.21|||||TWO_SIDED|97.6|10.3|18.13||||||||18.13|10.3|
71712195|NCT01346592|142940856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H3N2 strain)|7.31|||||TWO_SIDED|97.6|4.47|10.14||||||||10.14|4.47|
71712196|NCT01346592|142940856|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was \> -10%|Group difference (B strain)|11.1|||||TWO_SIDED|97.6|8.11|14.1||||||||14.1|8.11|
71712197|NCT01346592|142940857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|Group ratio (H1N1 strain)|0.76|||||TWO_SIDED|97.4|0.62|0.93||||||||0.93|0.62|
71712198|NCT01346592|142940857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (H3N2 strain)|0.77|||||TWO_SIDED|97.4|0.68|0.86||||||||0.86|0.68|
71712199|NCT01346592|142940857|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was \>0.667|GMT ratio (B strain)|0.94|||||TWO_SIDED|97.4|0.8|1.11||||||||1.11|0.8|
71712200|NCT01346592|142940858|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H1N1 strain)|-5.3|||||TWO_SIDED|97.4|-10.13|-0.47||||||||-0.47|-10.13|
71712201|NCT01346592|142940858|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (H3N2 strain)|-2.84|||||TWO_SIDED|97.4|-6.16|0.5||||||||0.5|-6.16|
71712202|NCT01346592|142940858|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was \> -10%|Group difference (B strain)|-2.49|||||TWO_SIDED|97.4|-7.01|2.0||||||||2|-7.01|
71712203|NCT01346592|142940859|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.63|||||TWO_SIDED|95.0|2.86|4.6||||||Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||4.6|2.86|
71712204|NCT01346592|142940859|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.25|||||TWO_SIDED|95.0|1.96|2.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.59|1.96|
71712205|NCT01346592|142940859|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
71712206|NCT01346592|142940859|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|5.28|||||TWO_SIDED|95.0|4.16|6.7||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||6.7|4.16|
71712207|NCT01346592|142940859|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|3.1|||||TWO_SIDED|95.0|2.69|3.56||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.56|2.69|
71712208|NCT01346592|142940859|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|4.64|||||TWO_SIDED|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||5.59|3.86|
71712209|NCT01346592|142940860|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|10.4|||||TWO_SIDED|95.0|6.1|14.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||14.7|6.1|
71712210|NCT01346592|142940860|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|2.5|||||TWO_SIDED|95.0|-0.12|5.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.1|-0.12|
71712211|NCT01346592|142940860|SUPERIORITY_OR_OTHER||Group difference (B strain)|12.8|||||TWO_SIDED|95.0|8.9|16.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||16.7|8.9|
71712212|NCT01346592|142940860|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|17.7|||||TWO_SIDED|95.0|12.9|22.6||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||22.6|12.9|
71712213|NCT01346592|142940860|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|5.6|||||TWO_SIDED|95.0|2.5|8.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||8.7|2.5|
71712214|NCT01346592|142940860|SUPERIORITY_OR_OTHER||Group difference (B strain)|18.8|||||TWO_SIDED|95.0|14.4|23.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||23.1|14.4|
71712215|NCT01346592|142940861|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|2.38|||||TWO_SIDED|95.0|2.07|2.75||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.75|2.07|
71712216|NCT01346592|142940861|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|1.88|||||TWO_SIDED|95.0|1.72|2.06||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.06|1.72|
71712217|NCT01346592|142940861|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|2.93|||||TWO_SIDED|95.0|2.6|3.3||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.3|2.6|
71712218|NCT01346592|142940861|SUPERIORITY_OR_OTHER||GMT Ratio (H1N1 strain)|3.21|||||TWO_SIDED|95.0|2.79|3.71||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.71|2.79|
71712219|NCT01346592|142940861|SUPERIORITY_OR_OTHER||GMT Ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.19|2.62||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||2.62|2.19|
71712220|NCT01346592|142940861|SUPERIORITY_OR_OTHER||GMT Ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.73|3.47||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was \>1.5||3.47|2.73|
71712221|NCT01346592|142940862|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.3|||||TWO_SIDED|95.0|6.3|12.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||12.4|6.3|
71712222|NCT01346592|142940862|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|3.9|||||TWO_SIDED|95.0|1.8|5.9||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||5.9|1.8|
71712223|NCT01346592|142940862|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.7|||||TWO_SIDED|95.0|8.1|13.3||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.3|8.1|
71712224|NCT01346592|142940862|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|14.4|||||TWO_SIDED|95.0|11.1|17.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||17.7|11.1|
71712225|NCT01346592|142940862|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|6.8|||||TWO_SIDED|95.0|4.5|9.1||||||superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||9.1|4.5|
71712226|NCT01346592|142940862|SUPERIORITY_OR_OTHER||Group difference (B strain)|10.9|||||TWO_SIDED|95.0|8.3|13.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was \>10%||13.4|8.3|
71712227|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.68|||||TWO_SIDED|95.0|2.3|3.12||||||No risk subjects.||3.12|2.3|
71712228|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.87|||||TWO_SIDED|95.0|1.7|2.05||||||No risk subjects.||2.05|1.7|
71712229|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.04|||||TWO_SIDED|95.0|2.68|3.44||||||No risk subjects.||3.44|2.68|
71712230|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.21|||||TWO_SIDED|95.0|1.11|4.42||||||At risk subjects.||4.42|1.11|
71766254|NCT00913458|143034237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01||||0.4664|TWO_SIDED|95.0|-15.0|6.9|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||6.9|-15.0|0.4664
71712231|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.45|||||TWO_SIDED|95.0|1.61|3.72||||||At risk subjects.||3.72|1.61|
71766255|NCT00913458|143034237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.57||||0.021|TWO_SIDED|95.0|-30.6|-2.6|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.6|-30.6|0.0210
71712232|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.46|||||TWO_SIDED|95.0|1.88|6.34||||||At risk subjects||6.34|1.88|
71766256|NCT00913458|143034237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56||||0.0713|TWO_SIDED|95.0|-26.2|1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||1.1|-26.2|0.0713
71712233|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratios (H1N1 strain)|3.52|||||TWO_SIDED|95.0|3.03|4.1||||||No risk subjects.||4.1|3.03|
71712234|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.36|||||TWO_SIDED|95.0|2.15|2.59||||||No risk subjects.||2.59|2.15|
71712235|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.14|||||TWO_SIDED|95.0|2.78|3.56||||||No risk subjects.||3.56|2.78|
71712236|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.7|||||TWO_SIDED|95.0|1.28|5.68||||||At risk subjects.||5.68|1.28|
71712237|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.25|||||TWO_SIDED|95.0|2.09|5.06||||||At risk subjects.||5.06|2.09|
71712238|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.76|||||TWO_SIDED|95.0|1.44|5.3||||||At risk subjects.||5.3|1.44|
71712239|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.81|||||TWO_SIDED|95.0|2.34|3.37||||||No risk subjects.||3.37|2.34|
71712240|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.04|||||TWO_SIDED|95.0|1.83|2.28||||||No risk subjects.||2.28|1.83|
71712241|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.74|||||TWO_SIDED|95.0|3.22|4.34||||||No risk subjects||4.34|3.22|
71712242|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.34|||||TWO_SIDED|95.0|0.92|6.0||||||At risk subjects.||6|0.92|
71712243|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.93|||||TWO_SIDED|95.0|1.57|5.45||||||At risk subjects.||5.45|1.57|
71712244|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.55|||||TWO_SIDED|95.0|2.52|12.0||||||At risk subjects||12|2.52|
71712245|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.66|||||TWO_SIDED|95.0|3.05|4.39||||||No risk subjects.||4.39|3.05|
71712246|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.68|||||TWO_SIDED|95.0|2.4|2.99||||||No risk subjects||2.99|2.4|
71712247|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.97|||||TWO_SIDED|95.0|3.42|4.61||||||No risk subjects.||4.61|3.42|
71712248|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.72|||||TWO_SIDED|95.0|1.02|7.31||||||At risk subjects.||7.31|1.02|
71827253|NCT02715258|143158953|SUPERIORITY||mixed-effects repeated measures|-0.41||||0.0012|TWO_SIDED|95.0|-0.66|-0.16||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) at Week 24||-0.16|-0.66|0.0012
71712249|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.5|||||TWO_SIDED|95.0|1.85|6.62||||||At risk subjects.||6.62|1.85|
71712250|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.26|||||TWO_SIDED|95.0|2.32|12.0||||||At risk subjects.||12|2.32|
71712251|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.55|||||TWO_SIDED|95.0|1.21|1.97||||||No risk subjects.||1.97|1.21|
71712252|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.51|||||TWO_SIDED|95.0|1.26|1.82||||||No risk subjects||1.82|1.26|
71712253|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.9|||||TWO_SIDED|95.0|1.52|2.38||||||No risk subjects||2.38|1.52|
71712254|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.76|||||TWO_SIDED|95.0|0.57|5.4||||||At risk subjects||5.4|0.57|
71712255|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.78|||||TWO_SIDED|95.0|1.09|2.89||||||At risk subjects||2.89|1.09|
71712256|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.82|||||TWO_SIDED|95.0|0.73|4.54||||||At risk subjects||4.54|0.73|
71712257|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.4|||||TWO_SIDED|95.0|1.89|3.05||||||No risk subjects||3.05|1.89|
71712258|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.29|1.85||||||No risk subjects.||1.85|1.29|
71712259|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.7|||||TWO_SIDED|95.0|1.36|2.11||||||No risk subjects||2.11|1.36|
71712260|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.12|||||TWO_SIDED|95.0|0.58|7.71||||||At risk subjects.||7.71|0.58|
71712261|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.81|||||TWO_SIDED|95.0|1.61|4.89||||||At risk subjects||4.89|1.61|
71712262|NCT01346592|142940867|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.17|||||TWO_SIDED|95.0|0.37|3.67||||||At risk subjects||3.67|0.37|
71712263|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%|Group difference (H1N1 strain)|9.0|||||TWO_SIDED|95.0|5.4|12.0||||||No risk subjects.||12|5.4|
71712264|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.6||||||No risk subjects.||6.6|1.8|
71712265|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|14.8||||||No risk subjects.||14.8|9.2|
71712266|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-24.0|18.7||||||At risk subjects.||18.7|-24|
71712267|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|1.0|||||TWO_SIDED|95.0|-21.2|18.9||||||At risk subjects.||18.9|-21.2|
71712268|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|14.0|||||TWO_SIDED|95.0|-1.6|29.5||||||At risk subjects.||29.5|-1.6|
71712269|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|14.0|||||TWO_SIDED|95.0|10.7|17.7||||||No risk subjects.||17.7|10.7|
71712270|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects.||9.8|4.6|
71712271|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.7|16.4||||||No risk subjects||16.4|10.7|
71712272|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-3.0|||||TWO_SIDED|95.0|-26.1|19.2||||||At risk subjects.||19.2|-26.1|
71712273|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-17.5|27.3||||||At risk subjects.||27.3|-17.5|
71712274|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|-4.4|29.2||||||At risk subjects.||29.2|-4.4|
71712275|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|11.0|||||TWO_SIDED|95.0|7.2|14.5||||||No risk subjects.||14.5|7.2|
71712276|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.6|7.5||||||No risk subjects.||7.5|2.6|
71712277|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|9.5|15.8||||||No risk subjects.||15.8|9.5|
71712278|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|5.0|||||TWO_SIDED|95.0|-24.7|26.3||||||At risk subjects.||26.3|-24.7|
71712279|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|-26.9|30.3||||||At risk subjects.||30.3|-26.9|
71712280|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-16.9|27.1||||||At risk subjects.||27.1|-16.9|
71712281|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.4|20.2||||||No risk subjects.||20.2|12.4|
71712282|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|5.1|10.5||||||No risk subjects||10.5|5.1|
71712283|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|12.0|18.6||||||No risk subjects||18.6|12|
71712284|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-27.1|25.5||||||At risk subjects||25.5|-27.1|
71712285|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|10.0|||||TWO_SIDED|95.0|-23.5|37.2||||||At risk subjects||37.2|-23.5|
71712286|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|16.0|||||TWO_SIDED|95.0|-10.7|38.0||||||At risk subjects.||38|-10.7|
71827254|NCT02715258|143158953|SUPERIORITY||mixed-effects repeated measures|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.39||The mixed-effects repeated measures analysis includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Change from baseline in HbA1c (%) across 24 weeks||-0.39|-0.76|<0.0001
71827255|NCT02715258|143158954|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0006|TWO_SIDED|95.0|1.69|6.8||The logistic regression includes country, background anti-diabetes treatment status, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as a fixed effect covariate.|ANCOVA|||Model-Adjusted proportion of subjects with HbA1c \<7% across 24 weeks||6.80|1.69|0.0006
71712287|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-4.2|10.4||||||No risk subjects.||10.4|-4.2|
71712288|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 subjects)|4.0|||||TWO_SIDED|95.0|-1.2|11.9||||||No risk subjects.||11.9|-1.2|
71827256|NCT02814643|143158955|OTHER||Geometric least-square mean ratio|0.87|||||TWO_SIDED|90.0|0.56|1.35|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.35|0.56|
71712289|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|8.0|||||TWO_SIDED|95.0|2.9|15.1||||||No risk subjects.||15.1|2.9|
71712290|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-42.4|32.0||||||At risk subjects.||32|-42.4|
71712291|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.2|16.6||||||At risk subjects.||16.6|-41.2|
71712292|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|25.0|||||TWO_SIDED|95.0|-7.1|53.9||||||At risk subjects.||53.9|-7.1|
71712293|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|8.0|||||TWO_SIDED|95.0|1.0|16.4||||||No risk subjects.||16.4|1|
71712294|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.0|16.1||||||No risk subjects.||16.1|2|
71712295|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|10.0||||||No risk subjects.||10|0|
71712296|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-1.0|||||TWO_SIDED|95.0|-42.1|43.0||||||At risk subjects.||43|-42.1|
71712297|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-10.0|||||TWO_SIDED|95.0|-41.5|28.7||||||At risk subjects||28.7|-41.5|
71712298|NCT01346592|142940868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-29.0|36.8||||||At risk subjects.||36.8|-29|
71712299|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|6.4|12.8||||||No risk subjects.||12.8|6.4|
71712300|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|1.8|6.4||||||No risk subjects.||6.4|1.8|
71712301|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|11.0|||||TWO_SIDED|95.0|8.6|13.9||||||No risk subjects.||13.9|8.6|
71827257|NCT02814643|143158955|OTHER||Geometric least-square mean ratio|1.19|||||TWO_SIDED|90.0|0.82|1.71|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.71|0.82|
71827258|NCT02814643|143158955|OTHER||Geometric least-square mean ratio|0.93|||||TWO_SIDED|90.0|0.67|1.29|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.29|0.67|
71712302|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-24.7|14.9||||||At risk subjects.||14.9|-24.7|
71712303|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|4.0|||||TWO_SIDED|95.0|-14.4|20.7||||||At risk subjects.||20.7|-14.4|
71712304|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|9.0|||||TWO_SIDED|95.0|-6.8|23.4||||||At risk subjects.||23.4|-6.8|
71712305|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|15.0|||||TWO_SIDED|95.0|11.3|18.1||||||No risk subjects.||18.1|11.3|
71712306|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.2|9.1||||||No risk subjects.||9.1|4.2|
71827259|NCT02814643|143158955|OTHER||Geometric least-square mean ratio|0.8|||||TWO_SIDED|90.0|0.54|1.19|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.19|0.54|
71827260|NCT02814643|143158956|OTHER||Geometric least-square mean ratio|1.0|||||TWO_SIDED|90.0|0.76|1.31|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H1N1||1.31|0.76|
71827261|NCT02814643|143158956|OTHER||Geometric least-square mean ratio|1.28|||||TWO_SIDED|90.0|0.93|1.77|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza A H3N2||1.77|0.93|
71827262|NCT02814643|143158956|OTHER||Geometric least-square mean ratio|1.03||||||90.0|0.79|1.34|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Yamagata lineage||1.34|0.79|
71827263|NCT02814643|143158956|OTHER||Geometric least-square mean ratio|1.26||||||90.0|0.93|1.7|||ANCOVA|The linear model effects are treatment group as a fixed effect and age group (adolescents and young adults) as fixed categorical covariate.||Influenza B Victoria lineage||1.70|0.93|
71712307|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|13.0|||||TWO_SIDED|95.0|10.5|16.1||||||No risk subjects.||16.1|10.5|
71712308|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-4.0|||||TWO_SIDED|95.0|-25.3|15.4||||||At risk subjects||15.4|-25.3|
71712309|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|6.0|||||TWO_SIDED|95.0|-12.7|24.2||||||At risk subjects.||24.2|-12.7|
71712310|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group differences (B strain)|8.0|||||TWO_SIDED|95.0|-7.8|23.2||||||At risk subjects.||23.2|-7.8|
71712311|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|12.0|||||TWO_SIDED|95.0|8.2|15.3||||||No risk subjects.||15.3|8.2|
71712312|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|5.0|||||TWO_SIDED|95.0|2.5|7.4||||||No risk subjects.||7.4|2.5|
71712313|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|12.0|||||TWO_SIDED|95.0|9.2|15.3||||||No risk subjects.||15.3|9.2|
71712314|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
71712315|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
71766257|NCT00913458|143034239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.0256|TWO_SIDED|95.0|-17.1|-1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-1.1|-17.1|0.0256
71827264|NCT02263508|143158965|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.04|0.71|0.13
71827265|NCT02263508|143158966|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.77|1.21|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.21|0.77|0.77
71827266|NCT02263508|143158974|OTHER||Odds Ratio (OR)|1.88||||0.012|TWO_SIDED|95.0|1.15|3.07|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||3.07|1.15|0.012
71827267|NCT02263508|143158975|OTHER||Hazard Ratio (HR)|1.05||||0.14|TWO_SIDED|95.0|0.82|1.34|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.34|0.82|0.14
71827268|NCT02263508|143158976|OTHER||Hazard Ratio (HR)|0.88||||0.47|TWO_SIDED|95.0|0.63|1.24|||Stratified log-rank test|Stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|Cox proportional hazards model stratified by randomization factors (disease stage, prior BRAF inhibitor therapy) and baseline PD-L1 status.|||1.24|0.63|0.47
71827269|NCT02263508|143158977|OTHER||Odds Ratio (OR)|1.32||||0.081|TWO_SIDED|95.0|0.97|1.79|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.79|0.97|0.081
71712316|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|2.0|||||TWO_SIDED|95.0|-20.7|19.7||||||At risk subjects.||19.7|-20.7|
71712317|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|16.0|||||TWO_SIDED|95.0|12.6|20.1||||||No risk subjects.||20.1|12.6|
71827270|NCT02263508|143158979|OTHER||Odds Ratio (OR)|1.39||||0.039|TWO_SIDED|95.0|1.02|1.9|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.90|1.02|0.039
71827271|NCT02263508|143158981|OTHER||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.75|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.75|0.94|0.11
71827272|NCT02263508|143158982|OTHER||Odds Ratio (OR)|1.44||||0.02|TWO_SIDED|95.0|1.06|1.96|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.96|1.06|0.020
71712318|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|7.0|||||TWO_SIDED|95.0|4.6|9.8||||||No risk subjects||9.8|4.6|
71712319|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|15.0|||||TWO_SIDED|95.0|11.9|18.3||||||No risk subjects.||18.3|11.9|
71712320|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-2.0|||||TWO_SIDED|95.0|-28.5|20.2||||||At risk subjects.||20.2|-28.5|
71712321|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|11.0|||||TWO_SIDED|95.0|-14.9|33.5||||||At risk subjects.||33.5|-14.9|
71712322|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|10.0|||||TWO_SIDED|95.0|-14.0|29.3||||||At risk subjects.||29.3|-14|
71712323|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|2.0|||||TWO_SIDED|95.0|-3.8|9.5||||||No risk subjects.||9.5|-3.8|
71712324|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|3.0|||||TWO_SIDED|95.0|-1.8|10.0||||||No risk subjects.||10|-1.8|
71712325|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|6.0|||||TWO_SIDED|95.0|1.5|12.5||||||No risk subjects.||12.5|1.5|
71712326|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-6.0|||||TWO_SIDED|95.0|-40.7|27.9||||||At risk subjects.||27.9|-40.7|
71712327|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.4|14.3||||||At risk subjects.||14.3|-38.4|
71712328|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|21.0|||||TWO_SIDED|95.0|-7.9|48.1||||||At risk subjects.||48.1|-7.9|
71712329|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|10.0|||||TWO_SIDED|95.0|3.0|18.5||||||No risk subjects.||18.5|3|
71712330|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|8.0|||||TWO_SIDED|95.0|2.2|15.6||||||No risk subjects.||15.6|2.2|
71712331|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|4.0|||||TWO_SIDED|95.0|0.0|9.6||||||No risk subjects.||9.6|0|
71712332|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H1N1 strain)|-5.0|||||TWO_SIDED|95.0|-41.7|35.0||||||At risk subjects.||35|-41.7|
71827273|NCT02263508|143158984|OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||2.17|1.16|0.004
71712333|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (H3N2 strain)|-9.0|||||TWO_SIDED|95.0|-38.6|23.4||||||At risk subjects.||23.4|-38.6|
71827274|NCT02263508|143158986|OTHER||Odds Ratio (OR)|1.35||||0.058|TWO_SIDED|95.0|0.99|1.85|||Regression, Logistic|Logistic regression stratified by randomization stratification factors (disease stage and prior BRAF inhibitor therapy) and the baseline PD-L1 status.|Adjusted odds ratio estimated using logistic regression with randomization stratification factors and baseline PD-L1 status.|||1.85|0.99|0.058
71712334|NCT01346592|142940869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|Group difference (B strain)|0.0|||||TWO_SIDED|95.0|-26.9|31.0||||||At risk subjects.||31|-26.9|
71712335|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.29|||||TWO_SIDED|95.0|1.91|2.76||||||No risk subjects.||2.76|1.91|
71712336|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.35|1.89||||||No risk subjects.||1.89|1.35|
71766258|NCT00913458|143034239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-28.1|-11.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-11.1|-28.1|<0.0001
71766259|NCT00913458|143034239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.51||||0.0161|TWO_SIDED|95.0|-19.0|-2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.||-2.0|-19.0|0.0161
71766260|NCT03595618|143034240|SUPERIORITY||Adjusted mean difference|0.04514|STANDARD_ERROR_OF_MEAN|0.02465||0.165|TWO_SIDED|95.0|-0.00317|0.09345||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using mixed-effects model for repeated measures (MMRM) including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value||0.09345|-0.00317|0.165
71766261|NCT03595618|143034240|SUPERIORITY||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.02585||0.939|TWO_SIDED|95.0|-0.03868|0.06267||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.06267|-0.03868|0.939
71766262|NCT03595618|143034240|SUPERIORITY||Adjusted mean difference|0.02329|STANDARD_ERROR_OF_MEAN|0.02536||0.682|TWO_SIDED|95.0|-0.02641|0.073|||Mixed Models Analysis||Two-sided 95% confidence interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose minus placebo using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.07300|-0.02641|0.682
71766263|NCT03595618|143034241|SUPERIORITY||Odds Ratio (OR)|1.47|STANDARD_ERROR_OF_MEAN|0.29||0.396|TWO_SIDED|95.0|0.84|2.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||2.58|0.84|0.396
71766264|NCT03595618|143034241|SUPERIORITY||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.26||0.951|TWO_SIDED|95.0|0.53|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.50|0.53|0.951
71712337|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.92|||||TWO_SIDED|95.0|2.57|3.31||||||No risk subjects.||3.31|2.57|
71712338|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.53|||||TWO_SIDED|95.0|0.6|3.93||||||At risk subjects.||3.93|0.6|
71655964|NCT00359788|142830296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083||||0.0044||95.0|-0.139|-0.026|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.026|-0.139|0.0044
71766265|NCT03595618|143034241|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.27||0.985|TWO_SIDED|95.0|0.64|1.83||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen||1.83|0.64|0.985
71766266|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.7||0.467|TWO_SIDED|95.0|-5.6|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-5.6|0.467
71655965|NCT00359788|142830297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.1182||95.0|-0.103|0.012|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.012|-0.103|0.1182
71655966|NCT00359788|142830298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.4814||95.0|-0.037|0.078||ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|ANCOVA|||||0.078|-0.037|0.4814
71712339|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.02|||||TWO_SIDED|95.0|0.89|4.61||||||At risk subjects.||4.61|0.89|
71827275|NCT02263508|143158987|OTHER||Difference|0.19|STANDARD_ERROR_OF_MEAN|0.95||0.84|TWO_SIDED|95.0|-1.67|2.05|||Mixed Model for Repeated Measures|||Mixed Model for Repeated Measures include the fixed and categorical effects of treatment, visit and treatment-by-visit interaction, the fixed and continuous covariates of baseline HRQL score, randomization stratification factors (stage of disease and prior BRAF inhibitor therapy per IVRS) and baseline PD-L1 status (positive and not positive). Random subject effect was modeled using within subject-error correlation structure.||2.05|-1.67|0.84
71827276|NCT00531518|143158989|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||The final analysis included adjstment for site and baseline sum psychotic symptom score.|Mixed Models Analysis|||The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.||||.0034
71827277|NCT03265210|143158990|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.39|TWO_SIDED|95.0|-4.95|1.95|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Baseline||1.95|-4.95|0.39
71827278|NCT03265210|143158990|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.03|TWO_SIDED|95.0|-7.19|-0.39|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|6 weeks||-0.39|-7.19|0.03
71827279|NCT03265210|143158990|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.42|TWO_SIDED|95.0|-5.38|2.26|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|9 weeks||2.26|-5.38|0.42
71827280|NCT03265210|143158990|SUPERIORITY||Mean Difference (Final Values)|-3.37||||0.07|TWO_SIDED|95.0|-7.02|0.28|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|12 weeks||0.28|-7.02|0.07
71827281|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.17|TWO_SIDED|95.0|-1.81|0.33|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, Baseline||0.33|-1.81|0.17
71827282|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.25|TWO_SIDED|95.0|-1.68|0.44|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 6 weeks||0.44|-1.68|0.25
71827283|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.09|TWO_SIDED|95.0|-2.29|0.17|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 9 weeks||0.17|-2.29|0.09
71827284|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.05|TWO_SIDED|95.0|-2.19|0.01|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1, 12 weeks||0.01|-2.19|0.05
71827285|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-3.19||||0.02|TWO_SIDED|95.0|-5.9|-0.48|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, Baseline||-0.48|-5.90|0.02
71827286|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.003|TWO_SIDED|95.0|-7.06|-1.54|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 6 weeks||-1.54|-7.06|0.003
71712340|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.5|||||TWO_SIDED|95.0|1.34|4.67||||||At risk subjects.||4.67|1.34|
71827287|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-5.95||||0.0001|TWO_SIDED|95.0|-8.85|-3.05|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 9 weeks||-3.05|-8.85|0.0001
71827288|NCT03265210|143158991|SUPERIORITY||Mean Difference (Final Values)|-4.35||||0.007|TWO_SIDED|95.0|-7.46|-1.24|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2, 12 weeks||-1.24|-7.46|0.007
71827289|NCT03265210|143158992|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0003|TWO_SIDED|95.0|0.53|1.69|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 1||1.69|0.53|0.0003
71827290|NCT03265210|143158992|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.001|TWO_SIDED|95.0|0.21|0.83|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 2||0.83|0.21|0.001
71827291|NCT03265210|143158992|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.002|TWO_SIDED|95.0|0.36|1.56|||t-test, 2 sided||Mean value in Relief Arm minus Mean value in Referral Arm.|Domain 3||1.56|0.36|0.002
71827292|NCT03923491|143158996|SUPERIORITY||Slope|-0.55|STANDARD_ERROR_OF_MEAN|4.69||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total score controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71827293|NCT03923491|143158996|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.49||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total vegetable component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71827294|NCT03923491|143158996|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 greens and beans component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
71827295|NCT03923491|143158996|SUPERIORITY||Slope|1.71|STANDARD_ERROR_OF_MEAN|0.67||0.2|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.20
71712341|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.33|||||TWO_SIDED|95.0|2.77|4.01||||||No risk subjects.||4.01|2.77|
71712342|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.07|||||TWO_SIDED|95.0|1.75|2.45||||||No risk subjects||2.45|1.75|
71766267|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.557|TWO_SIDED|95.0|-5.4|1.5||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.5|-5.4|0.557
71766268|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.8||0.593|TWO_SIDED|95.0|-5.3|1.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Total score: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.6|-5.3|0.593
71766269|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.776|TWO_SIDED|95.0|-1.0|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.0|0.776
71766270|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.446|TWO_SIDED|95.0|-1.2|0.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.3|-1.2|0.446
71766271|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.649|TWO_SIDED|95.0|-1.1|0.4||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Pain subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.4|-1.1|0.649
71766272|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.3||0.452|TWO_SIDED|95.0|-4.1|0.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.9|-4.1|0.452
71766273|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.3||0.665|TWO_SIDED|95.0|-3.7|1.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.3|-3.7|0.665
71775051|NCT01086423|143050304|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-7.93|||||TWO_SIDED|95.0|-14.44|-2.13||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.||-2.13|-14.44|
71775052|NCT01086423|143050305|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.||2.56|-2.51|
71827296|NCT03923491|143158996|SUPERIORITY||Slope|2.14|STANDARD_ERROR_OF_MEAN|0.83||0.19|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole fruit component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||0.19
71827297|NCT03923491|143158996|SUPERIORITY||Slope|0.83|STANDARD_ERROR_OF_MEAN|1.1||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 whole grain component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
71766274|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.3||0.598|TWO_SIDED|95.0|-3.9|1.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Physical Function subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||1.2|-3.9|0.598
71766275|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.400
71766276|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.393|TWO_SIDED|95.0|-0.6|0.1||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.1|-0.6|0.393
71827298|NCT03923491|143158996|SUPERIORITY||Slope|-0.9|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total dairy component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.0
71827299|NCT03923491|143158996|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.42||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 total protein foods component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71655967|NCT00359788|142830299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074||||0.008||95.0|0.019|0.129|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.129|0.019|0.008
71655968|NCT00359788|142830300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||<|0.0001||95.0|0.082|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|0.082|<0.0001
71655969|NCT00359788|142830301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.0001||95.0|-0.449|-0.29|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.29|-0.449|<0.0001
71655970|NCT00359788|142830302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.356|||<|0.0001||95.0|-0.44|-0.272|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.272|-0.44|<0.0001
71655971|NCT00359788|142830303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||<|0.0001||95.0|-0.451|-0.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.264|-0.451|<0.0001
71655972|NCT00359788|142830304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.285|||<|0.0001||95.0|-0.376|-0.194|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.194|-0.376|<0.0001
71655973|NCT00359788|142830305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0003||95.0|-0.261|-0.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.079|-0.261|0.0003
71655974|NCT00359788|142830306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.2992||95.0|-0.143|0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.044|-0.143|0.2992
71655975|NCT00359788|142830307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081||||0.0984||95.0|-0.015|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.177|-0.015|0.0984
71655976|NCT00359788|142830308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.379|0.178|<0.0001
71655977|NCT00359788|142830309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189||||0.0004||95.0|-0.293|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.293|0.0004
71655978|NCT00359788|142830310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0003||95.0|-0.314|-0.095|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.095|-0.314|0.0003
71655979|NCT00359788|142830311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832||||0.012||95.0|-0.293|-0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.072|-0.293|0.012
71827300|NCT03923491|143158996|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.85||-0.12|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 seafood and plant protein component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||-0.12
71827301|NCT03923491|143158996|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|1.12||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 fatty acid component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71827302|NCT03923491|143158996|SUPERIORITY||Slope|-2.09|STANDARD_ERROR_OF_MEAN|0.97||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 sodium component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71655980|NCT00359788|142830312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.044||95.0|-0.219|0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.003|-0.219|0.044
71655981|NCT00359788|142830313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3634||95.0|-0.058|0.158|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.158|-0.058|0.3634
71655982|NCT00359788|142830314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163||||0.0032||95.0|0.055|0.27|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.27|0.055|0.0032
71655983|NCT00359788|142830315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|||<|0.0001||95.0|0.173|0.378|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.378|0.173|<0.0001
71655984|NCT00359788|142830316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.283|0.067|0.0015
71655985|NCT00359788|142830317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193||||0.0002||95.0|-0.296|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.091|-0.296|0.0002
71655986|NCT00359788|142830318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215|||<|0.0001||95.0|-0.323|-0.108|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.108|-0.323|<0.0001
71655987|NCT00359788|142830319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.198||||0.0006||95.0|-0.309|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||-0.086|-0.309|0.0006
71655988|NCT00359788|142830320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097||||0.0896||95.0|-0.21|0.015|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.015|-0.21|0.0896
71655989|NCT00359788|142830321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8937||95.0|-0.103|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.118|-0.103|0.8937
71655990|NCT00359788|142830322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.0269||95.0|0.014|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|0.014|0.0269
71655991|NCT00359788|142830323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.0001||95.0|0.111|0.335|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.335|0.111|0.0001
71655992|NCT00359788|142830324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042||||0.7196||95.0|-0.275|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.19|-0.275|0.7196
71655993|NCT00359788|142830325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069||||0.6189||95.0|-0.343|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.343|0.6189
71655994|NCT00359788|142830326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073||||0.6197||95.0|-0.36|0.215|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.215|-0.36|0.6197
71655995|NCT00359788|142830327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112||||0.4582||95.0|-0.408|0.184|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.184|-0.408|0.4582
71655996|NCT00359788|142830328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6538||95.0|-0.376|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.236|-0.376|0.6538
71655997|NCT00359788|142830329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.4145||95.0|-0.495|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.205|-0.495|0.4145
71655998|NCT00359788|142830330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085||||0.6048||95.0|-0.408|0.238|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.238|-0.408|0.6048
71655999|NCT00359788|142830331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.3137||95.0|-0.503|0.162|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.162|-0.503|0.3137
71656000|NCT00359788|142830332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061||||0.7195||95.0|-0.395|0.273|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.273|-0.395|0.7195
71656001|NCT00359788|142830333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.7947||95.0|-0.367|0.282|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.282|-0.367|0.7947
71656002|NCT00359788|142830334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.093||||0.6049||95.0|-0.446|0.26|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.26|-0.446|0.6049
71656003|NCT00359788|142830335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047||||0.8109||95.0|-0.437|0.342|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.342|-0.437|0.8109
71766277|NCT03595618|143034242|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.858|TWO_SIDED|95.0|-0.5|0.2||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment|Stiffness subscore: Estimate (Standard Error) of adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose using MMRM including fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as continuous, fixed covariates of baseline and time-by-baseline interaction preceded by multiple imputation step for participants without post baseline value.||0.2|-0.5|0.858
71766278|NCT03595618|143034243|SUPERIORITY||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.5||0.705|TWO_SIDED|95.0|-7.1|2.7||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.7|-7.1|0.705
71766279|NCT03595618|143034243|SUPERIORITY||Adjusted mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.243|TWO_SIDED|95.0|-9.0|0.8||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.8|-9.0|0.243
71656004|NCT00359788|142830336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.527||||0.1471||95.0|-0.186|1.24|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||1.24|-0.186|0.1471
71827303|NCT03923491|143158996|SUPERIORITY||Slope|-0.8|STANDARD_ERROR_OF_MEAN|1.16||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 refined grains component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71827304|NCT03923491|143158996|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|1.13||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||Inverse probability of retention weighted normal linear regression models for between-arm differences in HEI-2015 added sugar component controlling for baseline HEI-2015 saturated fat, child involvement in food preparation, and receipt of any food assistance.||||1.00
71827305|NCT03923491|143158996|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.86||1|TWO_SIDED|||||Familywise error rates were controlled at alpha=.05 for primary and secondary outcomes separately using Holm's sequentially rejective procedure.|Regression, Linear|||||||1.00
71656005|NCT00359788|142830337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265||||0.3192||95.0|-0.258|0.788|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.788|-0.258|0.3192
71656006|NCT00359788|142830338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.351||||0.182||95.0|-0.165|0.867|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.867|-0.165|0.182
71656007|NCT00359788|142830339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1777||95.0|-0.166|0.893|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.893|-0.166|0.1777
71656008|NCT00359788|142830340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363||||0.1805||95.0|-0.169|0.895|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.895|-0.169|0.1805
71656009|NCT00359788|142830341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.1777||95.0|-0.17|0.913|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.913|-0.17|0.1777
71656010|NCT00359788|142830342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.5725||95.0|-0.395|0.714|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.714|-0.395|0.5725
71656011|NCT00359788|142830343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.6765||95.0|-0.449|0.69|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.69|-0.449|0.6765
71656012|NCT00359788|142830344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247||||0.3943||95.0|-0.323|0.818|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.818|-0.323|0.3943
71656013|NCT00359788|142830345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291||||0.3091||95.0|-0.271|0.852|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.852|-0.271|0.3091
71656014|NCT00359788|142830346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317||||0.2911||95.0|-0.273|0.907|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.907|-0.273|0.2911
71656015|NCT00359788|142830347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.7458||95.0|-0.549|0.766|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.766|-0.549|0.7458
71656016|NCT00359788|142830348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.698||||0.0004||95.0|4.836|16.56|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.56|4.836|0.0004
71656017|NCT00359788|142830349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.257||||0.0023||95.0|4.055|18.458|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||18.458|4.055|0.0023
71656018|NCT00359788|142830350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.772||||0.0015||95.0|4.942|20.602|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.602|4.942|0.0015
71827306|NCT02174562|143158999|SUPERIORITY||Risk Ratio (RR)|1.21||||0.31|TWO_SIDED|95.0|0.84|1.75||0.05 was the a priori level of significance.|Poisson regression with robust SEs||PC-OT is the numerator, Enhanced Usual care is the denominator|Null hypothesis is that the Relative Risk of reduction of HbA1C \>=0.5 for PCOT vs EUC is 1.||1.75|0.84|0.31
71886762|NCT00523991|143293833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.912||95.0|-7.9|7.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.06|-7.90|0.912
71656019|NCT00359788|142830351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.568||||0.0013||95.0|5.342|21.795|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.795|5.342|0.0013
71656020|NCT00359788|142830352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.052||||0.005||95.0|3.676|20.428|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.428|3.676|0.005
71656021|NCT00359788|142830353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.107||||0.0159||95.0|2.095|20.119|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.119|2.095|0.0159
71656022|NCT00359788|142830354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.057||||0.0219||95.0|1.613|20.501|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||20.501|1.613|0.0219
71656023|NCT00359788|142830355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.655||||0.0048||95.0|4.207|23.104|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||23.104|4.207|0.0048
71656024|NCT00359788|142830356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.231||||0.0058||95.0|4.153|24.31|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||24.31|4.153|0.0058
71656025|NCT00359788|142830357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.597||||0.0248||95.0|1.483|21.71|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.71|1.483|0.0248
71656026|NCT00359788|142830358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.001||||0.0325||95.0|0.924|21.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||21.079|0.924|0.0325
71656027|NCT00359788|142830359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.074||||0.0153||95.0|2.726|25.422|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||25.422|2.726|0.0153
71656028|NCT00359788|142830360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.755||||0.6105||95.0|-8.532|5.022|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||5.022|-8.532|0.6105
71656029|NCT00359788|142830361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.842||||0.8249||95.0|-6.642|8.326|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.326|-6.642|0.8249
71656030|NCT00359788|142830362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71||||0.4896||95.0|-5.001|10.421|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.421|-5.001|0.4896
71656031|NCT00359788|142830363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.898||||0.0935||95.0|-1.172|14.968|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.968|-1.172|0.0935
71656032|NCT00359788|142830364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.419||||0.4339||95.0|-5.17|12.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||12.007|-5.17|0.4339
71656033|NCT00359788|142830365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.971||||0.845||95.0|-10.74|8.799|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||8.799|-10.74|0.845
71656034|NCT00359788|142830366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194||||0.9696||95.0|-9.811|10.199|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||10.199|-9.811|0.9696
71656035|NCT00359788|142830367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.129||||0.3252||95.0|-5.117|15.376|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||15.376|-5.117|0.3252
71656036|NCT00359788|142830368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.062||||0.452||95.0|-6.558|14.683|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.683|-6.558|0.452
71656037|NCT00359788|142830369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14||||0.4388||95.0|-6.372|14.651|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||14.651|-6.372|0.4388
71656038|NCT00359788|142830370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.185||||0.8288||95.0|-9.595|11.964|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||11.964|-9.595|0.8288
71656039|NCT00359788|142830371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.204||||0.4929||95.0|-7.857|16.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||16.264|-7.857|0.4929
71656040|NCT00359788|142830372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204||||0.0754||95.0|-0.021|0.429|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.429|-0.021|0.0754
71656041|NCT00359788|142830373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251||||0.0765||95.0|-0.027|0.528|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.528|-0.027|0.0765
71656042|NCT00359788|142830374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151||||0.163||95.0|-0.061|0.363|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.363|-0.061|0.163
71656043|NCT00359788|142830375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285||||0.0085||95.0|0.073|0.496|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.||||0.496|0.073|0.0085
71656044|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Sensitivity|0.85|||||TWO_SIDED|95.0|0.79|0.89|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||0.89|0.79|
71712343|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.08|||||TWO_SIDED|95.0|2.72|3.49||||||No risk subjects||3.49|2.72|
71766280|NCT03595618|143034243|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.949|TWO_SIDED|95.0|-6.1|3.9||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.9|-6.1|0.949
71766281|NCT03595618|143034244|SUPERIORITY||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.89|TWO_SIDED|95.0|-3.4|6.3||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||6.3|-3.4|0.890
71766282|NCT03595618|143034244|SUPERIORITY||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.5||0.682|TWO_SIDED|95.0|-7.1|2.6||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||2.6|-7.1|0.682
71766283|NCT03595618|143034244|SUPERIORITY||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.5||1|TWO_SIDED|95.0|-4.8|5.0||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||5.0|-4.8|1.000
71766284|NCT03595618|143034245|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.21||0.991|TWO_SIDED|95.0|0.7|1.58||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.58|0.70|0.991
71766285|NCT03595618|143034245|SUPERIORITY||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.21||0.992|TWO_SIDED|95.0|0.64|1.43||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.43|0.64|0.992
71766286|NCT03595618|143034245|SUPERIORITY||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.21||0.653|TWO_SIDED|95.0|0.55|1.23||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Logistic Model||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error of log \[estimate\]) of the adjusted odds ratio between GLPG1972 dose regimen and placebo: between the proportions of participants with response: placebo versus GLPG1972 dose regimen.||1.23|0.55|0.653
71766287|NCT03595618|143034246|SUPERIORITY||Adjusted mean difference|0.03779|STANDARD_ERROR_OF_MEAN|0.02156||0.193|TWO_SIDED|95.0|-0.00448|0.08005||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08005|-0.00448|0.193
71827307|NCT02174562|143159000|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|P-value is for comparison of least squares means for period 2 (months 4-6).||Mixed effects linear regression was used to model the percentage of doses taken each month. Fixed effects were period (1-3 months, 4-6 months, 7-9 months, 10-12 months), randomization group, randomization by period interaction, stratification group, age, and run-in percentage doses taken. The outcome was transformed using the arcsin-square root transformation prior to analysis. A first-order autoregressive correlation structure was assumed.||||0.87
71827308|NCT00545844|143159055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71827309|NCT00545844|143159056|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71712344|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.71|||||TWO_SIDED|95.0|0.65|4.5||||||At risk subjects.||4.5|0.65|
71712345|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.22|||||TWO_SIDED|95.0|1.38|7.51||||||At risk subjects.||7.51|1.38|
71712346|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.1|||||TWO_SIDED|95.0|1.1|3.98||||||At risk subjects.||3.98|1.1|
71712347|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|2.59|||||TWO_SIDED|95.0|2.1|3.21||||||No risk subjects.||3.21|2.1|
71712348|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.08|||||TWO_SIDED|95.0|1.71|2.52||||||No risk subjects.||2.52|1.71|
71712349|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|3.73|||||TWO_SIDED|95.0|3.22|4.33||||||No risk subjects.||4.33|3.22|
71712350|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
71712351|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.86|||||TWO_SIDED|95.0|0.94|8.66||||||At risk subjects.||8.66|0.94|
71766288|NCT03595618|143034246|SUPERIORITY||Adjusted mean difference|0.0358|STANDARD_ERROR_OF_MEAN|0.02235||0.256|TWO_SIDED|95.0|-0.00801|0.07962||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.07962|-0.00801|0.256
71886763|NCT00523991|143293834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.162||95.0|-1.55|9.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.13|-1.55|0.162
71712352|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
71712353|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|3.67|||||TWO_SIDED|95.0|2.97|4.54||||||No risk subjects.||4.54|2.97|
71712354|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H3N2 strain)|2.78|||||TWO_SIDED|95.0|2.29|3.37||||||No risk subjects.||3.37|2.29|
71712355|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (B strain)|4.01|||||TWO_SIDED|95.0|3.46|4.65||||||No risk subjects.||4.65|3.46|
71712356|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was \> -10%.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|0.45|4.4||||||At risk subjects.||4.4|0.45|
71712357|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|4.32|||||TWO_SIDED|95.0|1.43|13.0||||||At risk subjects.||13|1.43|
71712358|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.69|||||TWO_SIDED|95.0|1.67|8.15||||||At risk subjects.||8.15|1.67|
71712359|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.35|||||TWO_SIDED|95.0|0.89|2.04||||||No risk subjects.||2.04|0.89|
71712360|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.59|||||TWO_SIDED|95.0|1.14|2.22||||||No risk subjects.||2.22|1.14|
71712361|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.68|||||TWO_SIDED|95.0|1.3|2.15||||||No risk subjects.||2.15|1.3|
71712362|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.73|||||TWO_SIDED|95.0|0.29|10.0||||||At risk subjects.||10|0.29|
71712363|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.16|||||TWO_SIDED|95.0|0.33|4.01||||||At risk subjects.||4.01|0.33|
71712364|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.45|||||TWO_SIDED|95.0|0.53|3.94||||||At risk subjects.||3.94|0.53|
71712365|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.24|||||TWO_SIDED|95.0|1.48|3.39||||||No risk subjects||3.39|1.48|
71712366|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.76|||||TWO_SIDED|95.0|1.26|2.46||||||No risk subjects.||2.46|1.26|
71712367|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.59|||||TWO_SIDED|95.0|1.24|2.04||||||No risk subjects||2.04|1.24|
71712368|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.48|||||TWO_SIDED|95.0|0.34|18.0||||||At risk subjects.||18|0.34|
71712369|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.98|||||TWO_SIDED|95.0|0.49|7.92||||||At risk subjects.||7.92|0.49|
71712370|NCT01346592|142940870|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|0.71|||||TWO_SIDED|95.0|0.23|2.16||||||At risk subjects.||2.16|0.23|
71712371|NCT01346592|142940873|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|4.07|||||TWO_SIDED|95.0|3.34|4.95||||||GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was \>1.0||4.95|3.34|
71712372|NCT01346592|142940873|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.95|||||TWO_SIDED|95.0|1.74|2.18||||||statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is \>1.0||2.18|1.74|
71766289|NCT03595618|143034246|SUPERIORITY||Adjusted mean difference|0.03884|STANDARD_ERROR_OF_MEAN|0.02243||0.201|TWO_SIDED|95.0|-0.00514|0.08281||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||0.08281|-0.00514|0.201
71827310|NCT00545844|143159057|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
71712373|NCT01346592|142940873|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|2.03|||||TWO_SIDED|95.0|1.73|2.39||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.39|1.73|
71712374|NCT01346592|142940873|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|3.82||||||95.0|3.14|4.64||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||4.64|3.14|
71712375|NCT01346592|142940873|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|2.4|||||TWO_SIDED|95.0|2.15|2.68||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.68|2.15|
71712376|NCT01346592|142940873|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.95|||||TWO_SIDED|95.0|1.65|2.29||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was \>1.0||2.29|1.65|
71712377|NCT02085720|142940894|NON_INFERIORITY_OR_EQUIVALENCE|Data were given as means and standard deviations, unless otherwise stated. AHI was categorized as ≥ 5, ≥ 10, ≥ 15 and ≥ 20. The frequency distribution of responses on the SHQ and their relationship to AHI was assessed with the chi-squared analysis. The association of variables such as age, BMI, neck circumference, ESS and sleep health questionnaire responses versus AHI was evaluated using one-way analysis of variance and Pearson Correlation Analysis.|||||<|0.05|||||||ANOVA|||||||<0.05
71712378|NCT04262479|142940931|OTHER||||||||||||||||||Counting number of events.|||
71712379|NCT04262479|142940932|OTHER||||||||||||||||||Counting number of events|||
71712380|NCT04262479|142940933|OTHER||||||<|0.001||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.001
71712381|NCT04262479|142940934|OTHER||||||<|0.05||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.05
71712382|NCT04262479|142940935|OTHER||||||<|0.61||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.61
71712383|NCT04262479|142940936|OTHER||||||<|0.3||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.30
71712384|NCT04262479|142940937|OTHER||||||<|0.002||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.002
71712385|NCT04262479|142940938|OTHER||||||<|0.72||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.72
71712386|NCT04262479|142940939|OTHER||||||<|0.03||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.03
71712387|NCT04262479|142940940|OTHER||||||<|0.044||||||P-value threshold for significance: \<0.05|Wilcoxon signed rank test|||||||<0.044
71827311|NCT00545844|143159058|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
71827312|NCT00545844|143159059|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)||||<0.001
71712388|NCT00937105|142940942|SUPERIORITY_OR_OTHER||Cumulative Probability of no-CIE|92.8|||||TWO_SIDED|95.0|88.6|96.9|||Kaplan-Meier|Cumulative Unadjusted Probability of remaining CIE-free presented for entire cohort (both solution groups) to remain consistent with the primary aim||Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort||96.9|88.6|
71712389|NCT00937105|142940943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.737||||0.3923|TWO_SIDED|95.0|0.49|6.156|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial lens bioburden|To determine if microbial contamination of lenses is a risk factor for CIE||6.156|0.49|0.3923
71712390|NCT00937105|142940944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7943|TWO_SIDED|95.0|0.167|10.393|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no corneal staining|||10.393|0.167|0.7943
71712391|NCT00937105|142940945|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.674||||0.5894|TWO_SIDED|95.0|0.161|2.822|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial case bioburden|||2.822|0.161|0.5894
71712392|NCT00937105|142940946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.406||||0.1742|TWO_SIDED|95.0|0.678|8.537||Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|Regression, Cox||referent is no substantial overall lid bioburden|||8.537|0.678|0.1742
71712393|NCT00937105|142940947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.22||||0.04|TWO_SIDED|95.0|1.1|24.7|||Regression, Cox|Multivariate model adjusted for solution, gender and age|referent is no substantial CNS lid bioburden|||24.70|1.10|0.04
71766290|NCT03595618|143034247|SUPERIORITY||Adjusted mean difference|3.12394|STANDARD_ERROR_OF_MEAN|3.13671||0.627|TWO_SIDED|95.0|-3.02464|9.27252||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an analysis of covariance (ANCOVA) including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||9.27252|-3.02464|0.627
71766291|NCT03595618|143034247|SUPERIORITY||Adjusted mean difference|0.46842|STANDARD_ERROR_OF_MEAN|3.21111||0.998|TWO_SIDED|95.0|-5.82659|6.76343||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||6.76343|-5.82659|0.998
71766292|NCT03595618|143034247|SUPERIORITY||Adjusted mean difference|4.11756|STANDARD_ERROR_OF_MEAN|3.2759||0.449|TWO_SIDED|95.0|-2.30536|10.54049||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: Placebo minus GLPG1972 dose regimen using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||10.54049|-2.30536|0.449
71766293|NCT03595618|143034248|SUPERIORITY||Adjusted mean difference|2.84781|STANDARD_ERROR_OF_MEAN|3.75674||0.789|TWO_SIDED|95.0|-4.51643|10.21205||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05)|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||10.21205|-4.51643|0.789
71827313|NCT00094809|143159067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.1|0.37|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||0.37|0.10|<0.0001
71827314|NCT00094809|143159068|SUPERIORITY_OR_OTHER||Treatment difference|-18.0|||<|0.0001||95.0|-26.2|-9.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||-9.8|-26.2|<0.0001
71886764|NCT00523991|143293835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59||||0.471||95.0|-4.51|9.69||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||9.69|-4.51|0.471
71712394|NCT03537508|142940948|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.86|||||TWO_SIDED|95.0|-4.38|8.64||||||Statistical analysis for Serogroup A||8.64|-4.38|
71712395|NCT03537508|142940948|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|8.75|||||TWO_SIDED|95.0|4.8|13.6||||||Statistical analysis for Serogroup C||13.60|4.80|
71712396|NCT03537508|142940948|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|4.09|||||TWO_SIDED|95.0|0.68|8.44||||||Statistical analysis for Serogroup Y||8.44|0.68|
71712397|NCT03537508|142940948|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|1.19|||||TWO_SIDED|95.0|-1.18|4.45||||||Statistical analysis for Serogroup W||4.45|-1.18|
71712398|NCT03537508|142940949|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|10.21|||||TWO_SIDED|95.0|4.98|15.59||||||Statistical analysis for Serogroup A||15.59|4.98|
71827315|NCT00094809|143159069|SUPERIORITY_OR_OTHER||Treatment difference|-12.0||||0.0646||95.0|-23.7|0.5|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)|||0.5|-23.7|0.0646
71827316|NCT00094809|143159070|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0384||95.0|0.07|1.0|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of pegfilgrastim group compared to placebo group|||1.00|0.07|0.0384
71827317|NCT00094809|143159071|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5514||95.0|0.26|2.04|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||2.04|0.26|0.5514
71712399|NCT03537508|142940949|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|7.83|||||TWO_SIDED|95.0|5.31|10.96||||||Statistical analysis for Serogroup C||10.96|5.31|
71712400|NCT03537508|142940949|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|6.53|||||TWO_SIDED|95.0|4.01|9.62||||||Statistical analysis for Serogroup Y||9.62|4.01|
71712401|NCT03537508|142940949|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in Percentage of Participants|5.72|||||TWO_SIDED|95.0|3.44|8.57||||||Statistical analysis for Serogroup W||8.57|3.44|
71712402|NCT04983979|142940973|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.752|0.552||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.552|-0.752|
71712403|NCT04983979|142940974|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.97|0.65|||||Only the mean difference for the study end (week 12) is presented here|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.65|-1.97|
71712404|NCT04983979|142940975|OTHER||Mean Difference (Final Values)|25.15|||||TWO_SIDED|95.0|-48.83|99.13|||||Difference in change in systolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||99.13|-48.83|
71712405|NCT04983979|142940975|OTHER||Mean Difference (Final Values)|8.78|||||TWO_SIDED|95.0|-22.92|40.47|||||Difference in change in diastolic blood pressure between study arms.|Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||40.47|-22.92|
71712406|NCT04983979|142940976|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
71712407|NCT04983979|142940977|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.00|0.00|
71712408|NCT04983979|142940978|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.174|0.674||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||0.674|-0.174|
71712409|NCT04983979|142940979|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-19.5|11.4||||||Due to the small sample size only an estimate of the difference between study arms was generated. No hypothesis tests were completed.||11.4|-19.5|
71712410|NCT05293314|142940981|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.964|||<|0.05|TWO_SIDED|95.0|0.932|0.996|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.996|0.932|<0.05
71712411|NCT05293314|142940981|OTHER|Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.|receiver operating characteristic|0.932|||<|0.05|TWO_SIDED|95.0|0.879|0.982|||Wilcoxon (Mann-Whitney)|||Evaluate the ability of the breath test model to distinguish bronchiectasis from healthy individuals by measuring the area under the receiver operating characteristic (ROC) curves. The maximum value in the area below the receiver is 1. The closer the value is to 1, the higher the prediction accuracy of the model.||0.982|0.879|<0.05
71712412|NCT05293314|142940982|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
71712413|NCT05293314|142940982|OTHER|Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.|Sensitivity|86.2|||||TWO_SIDED|95.0|77.1|95.2||||||Sensitivity=number of true positives/(number of true positives+number of false negatives) \* 100% Sensitivity is the rate of correctly judging patients.We calculated the sensitivity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the sensitivity is 100%. The higher the percentage is , the more sensitive of the model.||95.2|77.1|
71827318|NCT00094809|143159073|SUPERIORITY_OR_OTHER||Treatment difference|-3.5||||0.5434||95.0|-14.8|7.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference (pegfilgrastim group - placebo group) in the percentage of participants with a complete or partial response|||7.8|-14.8|0.5434
71827319|NCT00094809|143159074|SUPERIORITY_OR_OTHER||Treatment difference|-12.1||||||95.0|-28.1|4.0|||||Kaplan-Meier estimates of the difference in percent mortality for the pegfilgrastim group - placebo group. Median survival time was not reached for the pegfilgrastim group.|||4.0|-28.1|
71827320|NCT00094809|143159075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.0457||95.0|0.05|1.09|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group|||1.09|0.05|0.0457
71766294|NCT03595618|143034248|SUPERIORITY||Adjusted mean difference|-3.64759|STANDARD_ERROR_OF_MEAN|3.84747||0.661|TWO_SIDED|95.0|-11.19071|3.89553||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||3.89553|-11.19071|0.661
71766295|NCT03595618|143034248|SUPERIORITY||Adjusted mean difference|-2.55176|STANDARD_ERROR_OF_MEAN|3.81987||0.843|TWO_SIDED|95.0|-10.04053|4.93701||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|Mixed Models Analysis||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: placebo minus GLPG1972 dose regimen using a MMRM including the fixed, categorical effects of treatment, region (Asia and Rest of the World), time and treatment-by-time interaction, as well as the continuous, fixed covariates of baseline and time-by-baseline interaction preceded by a Multiple Imputation step for participants without post-baseline measurement.||4.93701|-10.04053|0.843
71827321|NCT00094809|143159076|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3792||95.0|0.32|1.53|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group|||1.53|0.32|0.3792
71712414|NCT05293314|142940983|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|92.5|||||TWO_SIDED|95.0|86.2|98.8||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||98.8|86.2|
71712415|NCT05293314|142940983|OTHER|Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.|Specificity|73.9|||||TWO_SIDED|95.0|56.0|91.9||||||Specificity=number of true negative cases/(number of true negative cases+number of false positive cases) \* 100% The specificity is the rate of correctly judging non patients.We calculated the specificity of the breath test model to distinguish bronchiectasis from healthy people.The maximum percentage of the specificity is 100%. The higher the percentage is , the more specificity of the model.||91.9|56|
71712416|NCT05395338|142941018|OTHER|cox proportional hazards models with stratification by matching pairs|Hazard Ratio (HR)|0.9||||0.183|TWO_SIDED|95.0|0.78|1.05|||Regression, Cox||rt-PA/non reperfusion|||1.05|0.78|0.183
71712417|NCT05395338|142941019|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.25|||<|0.001|TWO_SIDED|95.0|1.12|1.39|||Regression, Logistic|||||1.39|1.12|<0.001
71712418|NCT05395338|142941020|OTHER|Conditional logistic regression models with stratification by matching pairs.|Odds Ratio (OR)|1.23|||<|0.001|TWO_SIDED|95.0|1.11|1.36|||Regression, Logistic||rt-PA/non reperfusion|||1.36|1.11|<0.001
71827322|NCT02503202|143159109|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot B)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.14||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.14|0.77|<0.001
71827323|NCT02503202|143159109|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot C)|0.88|||<|0.001|TWO_SIDED|95.0|0.71|1.09||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.09|0.71|<0.001
71827324|NCT02503202|143159109|EQUIVALENCE|Lot consistency requires the 95% confidence interval of the GMT ratio of \>0.5 and ≤2.0 for the primary analysis and \>0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot B / Lot C)|0.94|||<|0.001|TWO_SIDED|95.0|0.77|1.15||Primary analysis: a p-value \<0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA|||||1.15|0.77|<0.001
71712419|NCT05395338|142941021|OTHER|Conditional logistic regression models with stratification by matching pairs|Odds Ratio (OR)|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.83|||Regression, Logistic||rt-PA/non reperfusion|||0.83|0.64|<0.001
71712420|NCT05395338|142941022|OTHER|Ordinal logistic regression models|Odds Ratio (OR)|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.93|||Regression, Logistic||rt-PA/non reperfusion|||0.93|0.77|<0.001
71712421|NCT00791648|142941024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Pearson x2|||||||.75
71712422|NCT00791648|142941025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||.56
71712423|NCT00791648|142941026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
71712424|NCT00791648|142941027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||.11
71712425|NCT00791648|142941028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71712426|NCT00791648|142941029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71712427|NCT02947984|142941049|OTHER|||||||0.234|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the overall cohort.||||0.234
71712428|NCT02947984|142941049|OTHER|||||||0.82|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the subgroup receiving treatment due to a sub-total resection||||.820
71712429|NCT02947984|142941049|OTHER|||||||0.061|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the sub-group receiving treatment due to recurrent disease||||.061
71766296|NCT03595618|143034249|SUPERIORITY||Adjusted mean difference|0.0951|STANDARD_ERROR_OF_MEAN|0.0499||0.141|TWO_SIDED|95.0|-0.0028|0.1929||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1929|-0.0028|0.141
71712430|NCT00836706|142941087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|85.2|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||120|85.2|
71712431|NCT00836706|142941088|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.7|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.7|
71712432|NCT00836706|142941089|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.4|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||114|88.4|
71712433|NCT01139515|142941091|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.7|||||TWO_SIDED|90.0|92.17|105.7||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.70|92.17|
71712434|NCT01139515|142941091|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.48|||||TWO_SIDED|90.0|102.23|117.24||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.24|102.23|
71766297|NCT03595618|143034249|SUPERIORITY||Adjusted mean difference|0.0158|STANDARD_ERROR_OF_MEAN|0.0519||0.981|TWO_SIDED|95.0|-0.0861|0.1177||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1177|-0.0861|0.981
71712435|NCT01139515|142941091|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|109.93|||||TWO_SIDED|90.0|102.65|117.72||||||Natural log transformed, dose-normalized AUC\[0- ∞\] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.72|102.65|
71712436|NCT01139515|142941092|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|99.41|||||TWO_SIDED|90.0|92.97|106.31||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||106.31|92.97|
71712437|NCT01139515|142941092|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.52|||||TWO_SIDED|90.0|103.36|118.18||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.18|103.36|
71712438|NCT01139515|142941092|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|110.44|||||TWO_SIDED|90.0|103.28|118.09||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.09|103.28|
71712439|NCT01139515|142941093|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric means ratio|101.81|||||TWO_SIDED|90.0|85.97|120.58||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||120.58|85.97|
71712440|NCT01139515|142941093|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|98.57|||||TWO_SIDED|90.0|83.23|116.73||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||116.73|83.23|
71827325|NCT02503202|143159110|OTHER||Risk Difference (RD)|1.1||||0.368|TWO_SIDED|95.0|-1.5|4.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||4.0|-1.5|0.368
71827326|NCT02503202|143159110|OTHER||Risk Difference (RD)|0.0||||0.989|TWO_SIDED|95.0|-3.1|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-3.1|0.989
71827327|NCT02503202|143159110|OTHER||Risk Difference (RD)|-1.1||||0.361|TWO_SIDED|95.0|-4.1|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.5|-4.1|0.361
71766298|NCT03595618|143034249|SUPERIORITY||Adjusted mean difference|0.0753|STANDARD_ERROR_OF_MEAN|0.0529||0.349|TWO_SIDED|95.0|-0.0286|0.1792||Two-sided adjusted p-value taking into account Dunnett adjustment (to be compared to 0.05).|ANCOVA||Two-sided 95% Confidence Interval of the estimate without Dunnett adjustment.|Estimate (Standard Error) of the adjusted difference from baseline to last post baseline value between treatment groups means: GLPG1972 dose regimen minus placebo using an ANCOVA including the factors treatment and region with baseline as covariate and no interaction, after a Multiple Imputation for missing data.||0.1792|-0.0286|0.349
71766299|NCT00917644|143034253|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|98.79||||||90.0|94.57|103.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||103.20|94.57|
71766300|NCT00917644|143034255|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%). AUCinf method of determination includes AUClast calculated value.|Ratio of adjusted geometric means|98.72||||||90.0|94.41|103.23|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||103.23|94.41|
71766301|NCT00917644|143034256|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|104.66||||||90.0|95.73|114.42|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Observed directly from data.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||114.42|95.73|
71712441|NCT01139515|142941093|SUPERIORITY_OR_OTHER_LEGACY||Adjusted ratio of geometric means|107.44|||||TWO_SIDED|90.0|90.72|127.25||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."||127.25|90.72|
71766302|NCT02279407|143034260|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.83||||0.046|TWO_SIDED|95.0|0.7|1.0||Hypotheses tested using Dunnett's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons versus a single control (placebo).|Mixed Models Analysis|||||1.00|0.70|0.046
71766303|NCT02279407|143034261|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.502|TWO_SIDED|95.0|0.75|1.11||Conditional upon rejection of at least 1 of the 3 hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.11|0.75|0.502
71827328|NCT02503202|143159110|OTHER||Risk Difference (RD)|1.2||||0.214|TWO_SIDED|95.0|-1.7|3.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.3|-1.7|0.214
71827329|NCT02503202|143159111|OTHER||Risk Difference (RD)|4.1||||0.16|TWO_SIDED|95.0|-1.6|9.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site erythema||9.9|-1.6|0.160
71827330|NCT02503202|143159111|OTHER||Risk Difference (RD)|-0.1||||0.971|TWO_SIDED|95.0|-6.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site erythema||6.0|-6.2|0.971
71827331|NCT02503202|143159111|OTHER||Risk Difference (RD)|-4.2||||0.151|TWO_SIDED|95.0|-10.0|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site erythema||1.5|-10.0|0.151
71827332|NCT02503202|143159111|OTHER||Risk Difference (RD)|5.8||||0.016|TWO_SIDED|95.0|1.4|9.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site erythema||9.9|1.4|0.016
71827333|NCT02503202|143159111|OTHER||Risk Difference (RD)|-6.2||||0.12|TWO_SIDED|95.0|-14.0|1.6|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site pain||1.6|-14.0|0.120
71827334|NCT02503202|143159111|OTHER||Risk Difference (RD)|-3.5||||0.38|TWO_SIDED|94.0|-11.4|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site pain||4.4|-11.4|0.380
71712442|NCT02541591|142941096|SUPERIORITY||Median ratio of final values|1.37||||0.0881|TWO_SIDED|95.0|0.95|1.98|||ANOVA|due to non normality of the residuals the data were log-transformed prior to the anova|the estimated mean difference obtained using the anova on the log-transformed data was back transformed thus yielding a ratio of median values|missing data were accounted for by multiple imputation||1.98|0.95|0.0881
71827335|NCT02503202|143159111|OTHER||Risk Difference (RD)|2.7||||0.499|TWO_SIDED|95.0|-5.1|10.4|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site pain||10.4|-5.1|0.499
71827336|NCT02503202|143159111|OTHER||Risk Difference (RD)|54.9|||<|0.001|TWO_SIDED|95.0|46.2|62.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site pain||62.3|46.2|<0.001
71827337|NCT02503202|143159111|OTHER||Risk Difference (RD)|4.0||||0.202|TWO_SIDED|95.0|-2.2|10.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site swelling||10.3|-2.2|0.202
71766304|NCT02279407|143034261|SUPERIORITY_OR_OTHER||Geometric mean ratio for difference|0.91||||0.562|TWO_SIDED|95.0|0.73|1.13||Conditional upon rejection of at least 1 of the hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis|||||1.13|0.73|0.562
71766305|NCT00864916|143034262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.52|||||||Regression, Linear|||||||0.52
71766306|NCT01816945|143034263|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
71766307|NCT01816945|143034266|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Two-sample t-test for PHQ-9 at 12 months||||0.96
71766308|NCT01816945|143034267|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Two-sample t-test for Social Network Score at 12 month||||0.043
71766309|NCT00422084|143034268|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 5% non-inferiority margin. Non-inferiority was demonstrated if the lower limit of the CI for the difference \>-5%.|ACPR percent difference|0.3||||0.578|TWO_SIDED|95.0|-0.7|1.8||If non-inferiority of PA is demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to AL is statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (AL) by more than -5%."||1.8|-0.7|0.578
71766310|NCT02788279|143034276|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9871|TWO_SIDED|95.0|0.73|1.38|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.38|0.73|0.9871
71766311|NCT02788279|143034276|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.336|TWO_SIDED|95.0|0.83|1.71|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.71|0.83|0.3360
71766312|NCT02788279|143034276|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9686|TWO_SIDED|95.0|0.74|1.38|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.38|0.74|0.9686
71766313|NCT02788279|143034276|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3553|TWO_SIDED|95.0|0.83|1.69|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.69|0.83|0.3553
71766314|NCT02788279|143034277|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1208|TWO_SIDED|95.0|0.94|1.65|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.65|0.94|0.1208
71766315|NCT02788279|143034277|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0509|TWO_SIDED|95.0|1.0|1.94|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.|||1.94|1.00|0.0509
71766316|NCT02788279|143034277|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.1726|TWO_SIDED|95.0|0.92|1.6|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.60|0.92|0.1726
71766317|NCT02788279|143034277|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.0467|TWO_SIDED|95.0|1.0|1.91|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.|||1.91|1.00|0.0467
71766318|NCT02788279|143034278|SUPERIORITY||Difference in Response Rates|0.51||||1|TWO_SIDED|95.0|-3.92|4.94|||Stratified Cochrane-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.94|-3.92|1.0000
71766319|NCT02788279|143034278|SUPERIORITY||Difference in Response Rates|0.0||||1|TWO_SIDED|95.0|-4.89|4.89|||Stratified Cochran-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.|||4.89|-4.89|1.0000
71766320|NCT01782469|143034287|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
71766321|NCT01782469|143034287|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
71766322|NCT01782469|143034287|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||<0.001
71827338|NCT02503202|143159111|OTHER||Risk Difference (RD)|-0.5||||0.878|TWO_SIDED|95.0|-7.1|6.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site swelling||6.1|-7.1|0.878
71766323|NCT01782469|143034287|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.001
71766324|NCT01782469|143034288|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||.130
71766325|NCT01782469|143034288|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.031
71827339|NCT02503202|143159111|OTHER||Risk Difference (RD)|-4.6||||0.154|TWO_SIDED|95.0|-10.9|1.7|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site swelling||1.7|-10.9|0.154
71827340|NCT02503202|143159111|OTHER||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|18.6|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site swelling||18.6|7.4|<0.001
71766326|NCT01782469|143034288|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.006
71766327|NCT01782469|143034288|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test|||||||0.003
71827341|NCT02503202|143159112|OTHER||Risk Difference (RD)|4.6||||0.176|TWO_SIDED|95.0|-2.1|11.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||11.4|-2.1|0.176
71712443|NCT01358734|142941102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.789||||0.119|TWO_SIDED|95.0|0.861|3.718|||Log Rank|||||3.718|0.861|0.119
71766328|NCT02614469|143034303|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|98.0|108.0|||||Fed/Fasting Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||108|98.0|
71766329|NCT02614469|143034304|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|99.3|||||TWO_SIDED|90.0|96.9|102.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||102|96.9|
71766330|NCT02614469|143034308|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|103.0|||||TWO_SIDED|90.0|90.9|118.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||118|90.9|
71766331|NCT02614469|143034309|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|83.4|||||TWO_SIDED|90.0|62.1|112.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.||112|62.1|
71827342|NCT02503202|143159112|OTHER||Risk Difference (RD)|-1.1||||0.769|TWO_SIDED|95.0|-8.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||6.0|-8.2|0.769
71712444|NCT01358734|142941102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.659||||0.014|TWO_SIDED|95.0|1.214|5.822|||Log Rank|||||5.822|1.214|0.014
71712445|NCT01358734|142941102|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367||||0.356|TWO_SIDED|95.0|0.704|2.653|||Log Rank|||||2.653|0.704|0.356
71766332|NCT02184572|143034334|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.|Difference in incidence of fever|1.11|||||TWO_SIDED|95.0|-0.93|2.89||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 39.0°C.||2.89|-0.93|
71766333|NCT02184572|143034334|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV\_MMR minus COM\_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.|Difference in incidence of fever|1.09|||||TWO_SIDED|95.0|-2.89|4.85||||||Difference between groups (INV\_MMR Group minus COM\_MMR Group) in incidence of fever \> 38.0°C.||4.85|-2.89|
71766334|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|26.5||||0.321|TWO_SIDED|95.0|-25.9|78.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||78.9|-25.9|0.321
71827343|NCT02503202|143159112|OTHER||Risk Difference (RD)|-5.7||||0.1|TWO_SIDED|95.0|-12.5|1.1|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||1.1|-12.5|0.100
71827344|NCT02503202|143159112|OTHER||Risk Difference (RD)|31.4|||<|0.001|TWO_SIDED|95.0|25.6|37.5|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||37.5|25.6|<0.001
71827345|NCT02503202|143159113|OTHER||Risk Difference (RD)|0.0||||0.983|TWO_SIDED|95.0|-4.2|4.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthralgia||4.1|-4.2|0.983
71827346|NCT02503202|143159113|OTHER||Risk Difference (RD)|-0.8||||0.699|TWO_SIDED|95.0|-5.1|3.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthralgia||3.4|-5.1|0.699
71712446|NCT03898180|142941144|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.4107|TWO_SIDED|95.0|0.72|1.14||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, programmed cell death ligand 1 (PD-L1) CPS, and ECOG performance status (PS).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.14|0.72|0.4107
71712447|NCT03898180|142941145|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3505|TWO_SIDED|95.0|0.87|1.48||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.48|0.87|0.3505
71712448|NCT03898180|142941146|SUPERIORITY||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-4.0|12.2|||||Based on Miettinen \& Nurminen method stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||12.2|-4.0|
71712449|NCT03898180|142941149|OTHER||Difference in least squares means|-3.07||||0.182|TWO_SIDED|95.0|-7.57|1.44||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|cLDA model||Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||1.44|-7.57|0.182
71712450|NCT03898180|142941150|OTHER||Hazard Ratio (HR)|1.64||||0.0005|TWO_SIDED|95.0|1.24|2.16||Two-sided p-value based on log rank test stratified on chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by chemotherapy ineligibility, PD-L1 CPS, and ECOG PS.|||2.16|1.24|0.0005
71712451|NCT00928668|142941165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.157|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|0.657|1.657|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.657|0.657|<0.0001
71766335|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|13.1||||0.62|TWO_SIDED|95.0|-38.9|65.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||65.1|-38.9|0.620
71712452|NCT00928668|142941165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.711|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|1.205|2.217|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.217|1.205|<0.0001
71712453|NCT00928668|142941165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.443|STANDARD_ERROR_OF_MEAN|0.248|<|0.0001|TWO_SIDED|95.0|1.952|2.935|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.935|1.952|<0.0001
71712454|NCT00928668|142941165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.984|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|2.486|3.483|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.483|2.486|<0.0001
71712455|NCT00928668|142941166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.139|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|1.645|2.633|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.633|1.645|<0.0001
71712456|NCT00928668|142941166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.636|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|2.135|3.136|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.136|2.135|<0.0001
71712457|NCT00928668|142941166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|3.074|4.046|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.046|3.074|<0.0001
71827347|NCT02503202|143159113|OTHER||Risk Difference (RD)|-0.8||||0.716|TWO_SIDED|95.0|-5.1|3.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthralgia||3.5|-5.1|0.716
71827348|NCT02503202|143159113|OTHER||Risk Difference (RD)|6.2||||0.012|TWO_SIDED|95.0|1.8|10.4|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthralgia||10.4|1.8|0.012
71827349|NCT02503202|143159113|OTHER||Risk Difference (RD)|0.7||||0.677|TWO_SIDED|95.0|-2.9|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthritis||4.4|-2.9|0.677
71712458|NCT00928668|142941166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.224|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|3.731|4.717|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.717|3.731|<0.0001
71712459|NCT00928668|142941167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.025|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|1.437|2.613|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.613|1.437|<0.0001
71712460|NCT00928668|142941167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.785|2.975|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.975|1.785|<0.0001
71712461|NCT00928668|142941167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549|STANDARD_ERROR_OF_MEAN|0.292|<|0.0001|TWO_SIDED|95.0|2.971|4.127|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||4.127|2.971|<0.0001
71712462|NCT00928668|142941167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.208|STANDARD_ERROR_OF_MEAN|0.296|<|0.0001|TWO_SIDED|95.0|3.622|4.794|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.794|3.622|<0.0001
71712463|NCT00928668|142941168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.907|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|1.322|2.492|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||2.492|1.322|<0.0001
71712464|NCT00928668|142941168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474|STANDARD_ERROR_OF_MEAN|0.299|<|0.0001|TWO_SIDED|95.0|1.822|3.066|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||3.066|1.822|<0.0001
71712465|NCT00928668|142941168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.327|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|2.752|3.902|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||3.902|2.752|<0.0001
71712466|NCT00928668|142941168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|0.294|<|0.0001|TWO_SIDED|95.0|3.637|4.803|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||4.803|3.637|<0.0001
71712467|NCT00928668|142941169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.692|1.766|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo|||1.766|0.692|<0.0001
71712468|NCT00928668|142941169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.281|2.369|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo|||2.369|1.281|<0.0001
71712469|NCT00928668|142941169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.114|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.578|2.65|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo|||2.650|1.578|<0.0001
71712470|NCT00928668|142941169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|2.11|3.181|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo|||3.181|2.110|<0.0001
71712471|NCT01838226|142941172|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.8|||Mixed Models Analysis|||||2.8|-1.3|0.50
71712472|NCT01838226|142941173|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-1.3|3.1|||Mixed Models Analysis|||||3.1|-1.3|
71712473|NCT01838226|142941174|SUPERIORITY||Mean Difference (Net)|-2.6|||||TWO_SIDED|95.0|-4.9|-0.2||||||||-0.2|-4.9|
71766336|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.0||||0.665|TWO_SIDED|95.0|-55.5|35.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||35.4|-55.5|0.665
71766337|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.6||||0.865|TWO_SIDED|95.0|-57.6|48.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||48.4|-57.6|0.865
71766338|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|31.9||||0.174|TWO_SIDED|95.0|-14.1|77.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||77.9|-14.1|0.174
71766339|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|19.3||||0.472|TWO_SIDED|95.0|-33.4|71.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||71.9|-33.4|0.472
71766340|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|42.4||||0.072|TWO_SIDED|95.0|-3.8|88.7||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||88.7|-3.8|0.072
71766341|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|21.9||||0.234|TWO_SIDED|95.0|-14.2|58.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||58.0|-14.2|0.234
71766342|NCT01328444|143034355|SUPERIORITY_OR_OTHER||Least squares mean difference|32.4||||0.08|TWO_SIDED|95.0|-3.9|68.8||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||68.8|-3.9|0.080
71766343|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.087||||0.003|TWO_SIDED|95.0|0.03|0.143||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.|||0.143|0.030|0.003
71766344|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.084|0.196||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.|||0.196|0.084|<0.001
71827350|NCT02503202|143159113|OTHER||Risk Difference (RD)|1.9||||0.25|TWO_SIDED|95.0|-1.4|5.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthritis||5.4|-1.4|0.250
71766345|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.099|||<|0.001|TWO_SIDED|95.0|0.05|0.148||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.|||0.148|0.050|<0.001
71827351|NCT02503202|143159113|OTHER||Risk Difference (RD)|1.1||||0.46|TWO_SIDED|95.0|-2.1|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthritis||4.5|-2.1|0.460
71712474|NCT03232567|142941194|SUPERIORITY|||||||0.2451|||||||Fisher Exact|||||||0.2451
71712475|NCT03232567|142941194|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
71712476|NCT03232567|142941194|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
71712477|NCT03232567|142941195|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||||||0.4828
71712478|NCT03232567|142941195|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
71712479|NCT03232567|142941195|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
71827352|NCT02503202|143159113|OTHER||Risk Difference (RD)|3.1||||0.041|TWO_SIDED|95.0|0.2|6.0|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthritis||6.0|0.2|0.041
71827353|NCT02503202|143159114|OTHER||Risk Difference (RD)|-1.5||||0.353|TWO_SIDED|95.0|-5.1|1.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||1.9|-5.1|0.353
71712480|NCT03232567|142941197|SUPERIORITY|||||||0.0169|||||||Fisher Exact|||NasoVAX low dose vs placebo||||0.0169
71712481|NCT03232567|142941197|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||NasoVAX medium dose vs placebo||||0.0063
71712482|NCT03232567|142941197|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||NasoVAX high dose vs placebo||||<0.0001
71712483|NCT02284893|142941271|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1001||0.0008|||||||Mixed Models Analysis|||||||0.0008
71827354|NCT02503202|143159114|OTHER||Risk Difference (RD)|-0.8||||0.62|TWO_SIDED|95.0|-4.2|2.5|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||2.5|-4.2|0.620
71712484|NCT02284893|142941272|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.175||0.0034|||||||Regression, Logistic|the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.||||||0.0034
71712485|NCT02284893|142941273|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.2891||0.0001|||||||Mixed Models Analysis|||||||0.0001
71712486|NCT02284893|142941274|SUPERIORITY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|3.682||0.0001|||||||Mixed Models Analysis|||||||0.0001
71712487|NCT02421094|142941309|SUPERIORITY|||||||0.1621|||||||ANCOVA|||||||0.1621
71712488|NCT02421094|142941310|SUPERIORITY|||||||0.9835|||||||ANCOVA|||||||0.9835
71712489|NCT02421094|142941311|SUPERIORITY|||||||0.266|||||||ANCOVA|||||||0.2660
71712490|NCT03126630|142941323|EQUIVALENCE|The null hypothesis that there are no differences between the classes in the population. The purpose of the test is to evaluate how likely the observed frequencies would be assuming the null hypothesis is true.||||||0.27541|||||||Chi-squared|||||||0.27541
71712491|NCT03126630|142941326|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.1936|TWO_SIDED|95.0|0.0||Not enough events||Log Rank||||||0.0|0.1936
71712492|NCT03126630|142941327|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.1952|TWO_SIDED|95.0|0.73|4.51|||Log Rank|||||4.51|0.73|0.1952
71712493|NCT00071032|142941365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.84|1.22|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.22|0.84|
71712494|NCT00071032|142941366|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9|||||TWO_SIDED|99.0|-3.3|1.6|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)|||1.6|-3.3|
71712495|NCT05078112|142941396|OTHER|||||||0.000393|||||||t-test, 2 sided|||||||0.000393
71712496|NCT01969058|142941400|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.||||0.030
71712497|NCT02757768|142941460|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.039|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.039
71712498|NCT02757768|142941461|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.558|TWO_SIDED|95.0|-0.46|0.25|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.25|-0.46|0.558
71712499|NCT02757768|142941461|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.89|-0.14|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.14|-0.89|0.007
71712500|NCT02757768|142941461|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.041|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.02|-0.76|0.041
71712501|NCT02757768|142941462|SUPERIORITY||LS Mean of Difference|3.87|STANDARD_ERROR_OF_MEAN|2.8||0.167|TWO_SIDED|95.0|-1.63|9.37|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||9.37|-1.63|0.167
71712502|NCT02757768|142941462|SUPERIORITY||LS Mean of Difference|6.29|STANDARD_ERROR_OF_MEAN|3.28||0.056|TWO_SIDED|95.0|-0.15|12.73|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||12.73|-0.15|0.056
71766346|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.067|0.181||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.|||0.181|0.067|<0.001
71712503|NCT02757768|142941462|SUPERIORITY||LS Mean of Difference|8.99|STANDARD_ERROR_OF_MEAN|3.58||0.012|TWO_SIDED|95.0|1.97|16.01|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||16.01|1.97|0.012
71712504|NCT02757768|142941462|SUPERIORITY||LS Mean of Difference|9.25|STANDARD_ERROR_OF_MEAN|3.43||0.007|TWO_SIDED|95.0|2.53|15.98|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||15.98|2.53|0.007
71712505|NCT02757768|142941463|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.747|TWO_SIDED|95.0|-0.63|0.38|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.63|0.747
71712506|NCT02757768|142941463|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.393|TWO_SIDED|95.0|-0.72|0.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.54|-0.72|0.393
71712507|NCT02757768|142941463|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.32||0.672|TWO_SIDED|95.0|-0.87|0.38|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.38|-0.87|0.672
71766347|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.111|||<|0.001|TWO_SIDED|95.0|0.062|0.161||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.|||0.161|0.062|<0.001
71766348|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.32|TWO_SIDED|95.0|-0.028|0.086||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.086|-0.028|0.320
71766349|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.07||||0.007|TWO_SIDED|95.0|0.019|0.12||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.|||0.120|0.019|0.007
71827355|NCT02503202|143159114|OTHER||Risk Difference (RD)|0.8||||0.663|TWO_SIDED|95.0|-2.9|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||4.5|-2.9|0.663
71827356|NCT02503202|143159114|OTHER||Risk Difference (RD)|2.3||||0.202|TWO_SIDED|95.0|-1.8|5.7|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||5.7|-1.8|0.202
71712508|NCT02757768|142941463|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.64|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.30|-0.90|0.640
71766350|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.211|||<|0.001|TWO_SIDED|95.0|0.172|0.249||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.249|0.172|<0.001
71766351|NCT01328444|143034356|SUPERIORITY_OR_OTHER||Least squares mean difference|0.169|||<|0.001|TWO_SIDED|95.0|0.129|0.209||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.|||0.209|0.129|<0.001
71766352|NCT00561977|143034363|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Mixed Models Analysis|time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.||Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).||||0.14
71766353|NCT04345367|143034370|SUPERIORITY||Estimate of difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.8|29.5||Cochran-Mantel-Haenszel (CMH) method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.5|15.8|<0.0001
71766354|NCT04345367|143034371|SUPERIORITY||Estimate of difference|14.1|||<|0.0001|TWO_SIDED|95.0|8.2|20.0||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|8.2|<0.0001
71766355|NCT04345367|143034372|SUPERIORITY||Estimate of difference|12.5||||0.0008|TWO_SIDED|95.0|5.3|19.7||CMH method adjusted by baseline disease severity.|Cochran-Mantel-Haenszel||The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.7|5.3|0.0008
71712509|NCT02757768|142941464|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|-0.68|0.16|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.16|-0.68|0.222
71712510|NCT02757768|142941464|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.003|TWO_SIDED|95.0|-1.18|-0.24|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.24|-1.18|0.003
71712511|NCT02757768|142941464|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.24||0.008|TWO_SIDED|95.0|-1.13|-0.17|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.17|-1.13|0.008
71766356|NCT04345367|143034373|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|0.2|8.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||8.7|0.2|
71766357|NCT04345367|143034373|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.2|26.9|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|13.2|
71766358|NCT04345367|143034373|OTHER||Estimate of difference|14.0|||||TWO_SIDED|95.0|6.9|21.1|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.1|6.9|
71766359|NCT04345367|143034373|OTHER||Estimate of difference|12.7|||||TWO_SIDED|95.0|5.5|20.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.0|5.5|
71827357|NCT02503202|143159115|OTHER||Risk Difference (RD)|0.7||||0.483|TWO_SIDED|95.0|-1.6|3.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|||3.3|-1.6|0.483
71712512|NCT02757768|142941464|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.13|-0.21|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-0.21|-1.13|0.004
71766360|NCT04345367|143034373|OTHER||Estimate of difference|6.9|||||TWO_SIDED|95.0|-0.4|14.3|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.3|-0.4|
71827358|NCT02503202|143159115|OTHER||Risk Difference (RD)|0.4||||0.746|TWO_SIDED|95.0|-2.2|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|||3.0|-2.2|0.746
71766361|NCT04345367|143034374|OTHER||Estimate of difference|8.1|||||TWO_SIDED|95.0|1.8|14.4|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||14.4|1.8|
71766362|NCT04345367|143034374|OTHER||Estimate of difference|20.9|||||TWO_SIDED|95.0|13.8|28.0|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.0|13.8|
71827359|NCT02503202|143159115|OTHER||Risk Difference (RD)|-0.4||||0.704|TWO_SIDED|95.0|-2.8|2.0|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|||2.0|-2.8|0.704
71827360|NCT02503202|143159115|OTHER||Risk Difference (RD)|1.5||||0.151|TWO_SIDED|95.0|-1.3|3.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|||3.9|-1.3|0.151
71827361|NCT04059237|143159116|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
71827362|NCT04059237|143159117|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<.001
71827363|NCT04059237|143159118|OTHER||||||<|0.001||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||<0.001
71712513|NCT02757768|142941465|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.723|TWO_SIDED|95.0|-0.6|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.6|0.723
71712514|NCT02757768|142941465|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.7|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.0|-0.7|0.700
71712515|NCT02757768|142941465|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-1.3|0.400
71712516|NCT02757768|142941465|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.812|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-1.0|0.812
71712517|NCT02757768|142941466|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.121|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.9|-0.1|0.121
71712518|NCT02757768|142941466|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.241|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.8|-0.2|0.241
71712519|NCT02757768|142941466|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.843|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.5|-0.6|0.843
71712520|NCT02757768|142941466|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.679|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.7|-0.4|0.679
71712521|NCT02757768|142941467|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.175|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.7|0.175
71712522|NCT02757768|142941467|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.6|0.430
71712523|NCT02757768|142941467|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.141|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.8|0.141
71712524|NCT02757768|142941467|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.288|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.2|-0.7|0.288
71712525|NCT02757768|142941468|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.3|0.128
71766363|NCT04345367|143034374|OTHER||Estimate of difference|18.4|||||TWO_SIDED|95.0|11.4|25.3|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||25.3|11.4|
71766364|NCT04345367|143034374|OTHER||Estimate of difference|14.9|||||TWO_SIDED|95.0|8.2|21.5|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||21.5|8.2|
71827364|NCT04059237|143159119|OTHER|||||||0.1||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.10
71827365|NCT04059237|143159120|OTHER|||||||0.01||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||.01
71827366|NCT04059237|143159121|OTHER|||||||0.59||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.59
71827367|NCT04059237|143159122|OTHER|||||||0.02||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.02
71827368|NCT04059237|143159123|OTHER|||||||0.52||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.52
71827369|NCT04059237|143159124|OTHER|||||||0.08||||||Repeated measures ANOVA evaluated change in outcome variables across the study time points.|ANOVA|||||||0.08
71827370|NCT01460342|143159143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.4|-0.6|||Mixed Models Analysis|||||-0.6|-2.4|<0.001
71712526|NCT02757768|142941468|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.054
71712527|NCT02757768|142941468|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.079|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.0|-0.4|0.079
71712528|NCT02757768|142941468|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.148|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.4|0.148
71712529|NCT02757768|142941469|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|95.0|-0.61|0.39|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.39|-0.61|0.660
71712530|NCT02757768|142941469|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.32||0.767|TWO_SIDED|95.0|-0.72|0.53|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.53|-0.72|0.767
71712531|NCT02757768|142941469|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.372|TWO_SIDED|95.0|-0.89|0.34|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.89|0.372
71712532|NCT02757768|142941469|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.3||0.272|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.26|-0.92|0.272
71712533|NCT02757768|142941470|SUPERIORITY||LS Mean of Difference|-1.75|STANDARD_ERROR_OF_MEAN|1.3||0.179|TWO_SIDED|95.0|-4.29|0.8|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-4.29|0.179
71712534|NCT02757768|142941470|SUPERIORITY||LS Mean of Difference|-3.84|STANDARD_ERROR_OF_MEAN|1.41||0.006|TWO_SIDED|95.0|-6.6|-1.08|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||-1.08|-6.60|0.006
71712535|NCT02757768|142941470|SUPERIORITY||LS Mean of Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.51||0.055|TWO_SIDED|95.0|-5.86|0.06|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.06|-5.86|0.055
71712536|NCT02757768|142941470|SUPERIORITY||LS Mean of Difference|-2.11|STANDARD_ERROR_OF_MEAN|1.48||0.154|TWO_SIDED|95.0|-5.02|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.80|-5.02|0.154
71712537|NCT02757768|142941471|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|1.13||0.233|TWO_SIDED|95.0|-3.57|0.87|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.87|-3.57|0.233
71712538|NCT02757768|142941471|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.2||0.698|TWO_SIDED|95.0|-1.89|2.82|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.82|-1.89|0.698
71712539|NCT02757768|142941471|SUPERIORITY||LS Mean of Difference|0.89|STANDARD_ERROR_OF_MEAN|1.28||0.486|TWO_SIDED|95.0|-1.62|3.4|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.40|-1.62|0.486
71712540|NCT02757768|142941471|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.968|TWO_SIDED|95.0|-2.52|2.42|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.42|-2.52|0.968
71827371|NCT01460342|143159144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-0.5||The p-value is for the change from baseline in the IPSS Total Score at Week 4.|Mixed Models Analysis|||||-0.5|-2.0|<0.001
71712541|NCT02757768|142941472|SUPERIORITY||LS Mean of Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.36||0.165|TWO_SIDED|95.0|-4.56|0.78|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.78|-4.56|0.165
71766365|NCT04345367|143034374|OTHER||Estimate of difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.0|3.0|
71827372|NCT01460342|143159144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-2.0|-0.4||The p-value is for the change from baseline in the IPSS Total Score at Week 8.|Mixed Models Analysis|||||-0.4|-2.0|0.003
71712542|NCT02757768|142941472|SUPERIORITY||LS Mean of Difference|0.76|STANDARD_ERROR_OF_MEAN|1.41||0.592|TWO_SIDED|95.0|-2.02|3.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.54|-2.02|0.592
71712543|NCT02757768|142941472|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|1.54||0.559|TWO_SIDED|95.0|-2.12|3.92|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.92|-2.12|0.559
71712544|NCT02757768|142941472|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|1.51||0.985|TWO_SIDED|95.0|-2.94|3.0|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.00|-2.94|0.985
71712545|NCT02757768|142941473|SUPERIORITY||LS Mean of Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.29||0.161|TWO_SIDED|95.0|-4.35|0.72|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.72|-4.35|0.161
71712546|NCT02757768|142941473|SUPERIORITY||LS Mean of Difference|0.35|STANDARD_ERROR_OF_MEAN|1.38||0.798|TWO_SIDED|95.0|-2.36|3.07|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.07|-2.36|0.798
71712547|NCT02757768|142941473|SUPERIORITY||LS Mean of Difference|1.17|STANDARD_ERROR_OF_MEAN|1.42||0.408|TWO_SIDED|95.0|-1.61|3.95|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.95|-1.61|0.408
71712548|NCT02757768|142941473|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|1.39||0.919|TWO_SIDED|95.0|-2.6|2.88|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.88|-2.60|0.919
71712549|NCT02757768|142941474|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|1.49||0.99|TWO_SIDED|95.0|-2.94|2.91|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.91|-2.94|0.990
71712550|NCT02757768|142941474|SUPERIORITY||LS Mean of Difference|0.92|STANDARD_ERROR_OF_MEAN|1.55||0.554|TWO_SIDED|95.0|-2.12|3.96|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.96|-2.12|0.554
71712551|NCT02757768|142941474|SUPERIORITY||LS Mean of Difference|1.53|STANDARD_ERROR_OF_MEAN|1.63||0.348|TWO_SIDED|95.0|-1.67|4.73|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||4.73|-1.67|0.348
71712552|NCT02757768|142941474|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|1.6||0.876|TWO_SIDED|95.0|-2.89|3.38|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||3.38|-2.89|0.876
71712553|NCT02757768|142941475|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.05||0.293|TWO_SIDED|95.0|-3.16|0.95|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.95|-3.16|0.293
71712554|NCT02757768|142941475|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.773|TWO_SIDED|95.0|-2.52|1.87|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.87|-2.52|0.773
71712555|NCT02757768|142941475|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.12||0.94|TWO_SIDED|95.0|-2.28|2.11|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||2.11|-2.28|0.940
71766366|NCT04345367|143034374|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.4|11.5|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.5|-1.4|
71766367|NCT04345367|143034374|OTHER||Estimate of difference|0.7|||||TWO_SIDED|95.0|-5.9|7.2|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||7.2|-5.9|
71766368|NCT04345367|143034375|OTHER||Estimate of difference|7.3|||||TWO_SIDED|95.0|2.8|11.7|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.7|2.8|
71827373|NCT01460342|143159145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.09|TWO_SIDED|95.0|-0.6|0.0||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 4.|Mixed Models Analysis|||||0.0|-0.6|0.090
71766369|NCT04345367|143034375|OTHER||Estimate of difference|20.6|||||TWO_SIDED|95.0|14.3|26.9|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.9|14.3|
71712556|NCT02757768|142941475|SUPERIORITY||LS Mean of Difference|-0.71|STANDARD_ERROR_OF_MEAN|1.1||0.516|TWO_SIDED|95.0|-2.86|1.44|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||1.44|-2.86|0.516
71712557|NCT02757768|142941476|SUPERIORITY|||||||0.4591|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 4 Placebo vs. Mirabegron.||||0.4591
71712558|NCT02757768|142941476|SUPERIORITY|||||||0.4073|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 8 Placebo vs. Mirabegron.||||0.4073
71712559|NCT02757768|142941476|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 12 Placebo vs. Mirabegron.||||0.7740
71712560|NCT02757768|142941476|SUPERIORITY|||||||0.5121|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||EoT Placebo vs. Mirabegron.||||0.5121
71712561|NCT02757768|142941477|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.223|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.223
71712562|NCT02757768|142941477|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.598
71712563|NCT02757768|142941477|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.3|0.312
71712564|NCT02757768|142941477|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.525|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.1|-0.2|0.525
71712565|NCT02757768|142941479|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.226|TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.34|-0.08|0.226
71712566|NCT02757768|142941479|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.501|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.28|-0.14|0.501
71712567|NCT02757768|142941479|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.984|TWO_SIDED|95.0|-0.22|0.23|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.23|-0.22|0.984
71712568|NCT02757768|142941479|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||0.24|-0.18|0.780
71712569|NCT02757768|142941480|SUPERIORITY||LS Mean of Difference|3.1|STANDARD_ERROR_OF_MEAN|1.9||0.107|TWO_SIDED|95.0|-0.7|6.8|||ANCOVA|||Week 4 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.8|-0.7|0.107
71712570|NCT02757768|142941480|SUPERIORITY||LS Mean of Difference|2.5|STANDARD_ERROR_OF_MEAN|1.9||0.19|TWO_SIDED|95.0|-1.3|6.3|||ANCOVA|||Week 8 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.3|0.190
71712571|NCT02757768|142941480|SUPERIORITY||LS Mean of Difference|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.297|TWO_SIDED|95.0|-1.9|6.3|||ANCOVA|||Week 12 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||6.3|-1.9|0.297
71712572|NCT02757768|142941480|SUPERIORITY||LS Mean of Difference|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.493|TWO_SIDED|95.0|-2.7|5.5|||ANCOVA|||EoT Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (\<65, \>=65 years) and geographical region as fixed factors and baseline value as a covariate.||5.5|-2.7|0.493
71712573|NCT02445911|142941496|OTHER||Least-squares Mean Difference|-6.78|||||TWO_SIDED|95.0|-23.75|10.18|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||10.18|-23.75|
71827374|NCT01460342|143159145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.8|-0.1||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 8.|Mixed Models Analysis|||||-0.1|-0.8|0.011
71712574|NCT02445911|142941496|OTHER||Least-squares Mean Difference|-2.97|||||TWO_SIDED|95.0|-19.65|13.72|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||13.72|-19.65|
71766370|NCT04345367|143034375|OTHER||Estimate of difference|19.5|||||TWO_SIDED|95.0|12.5|26.4|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.4|12.5|
71766371|NCT04345367|143034375|OTHER||Estimate of difference|15.8|||||TWO_SIDED|95.0|8.7|23.0|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||23.0|8.7|
71827375|NCT01460342|143159145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-0.9|-0.2||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 12.|Mixed Models Analysis|||||-0.2|-0.9|0.002
71827376|NCT01460342|143159146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.5|-0.4||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 4.|Mixed Models Analysis|||||-0.4|-1.5|<0.001
71827377|NCT01460342|143159146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.3|-0.2||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 8.|Mixed Models Analysis|||||-0.2|-1.3|0.007
71712575|NCT02445911|142941496|OTHER||Least-squares Mean Difference|-5.05|||||TWO_SIDED|95.0|-21.97|11.88|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.|||11.88|-21.97|
71712576|NCT01649869|142941514|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome based on generalized estimating equations.||||||0.0859
71712577|NCT01649869|142941515|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
71712578|NCT01649869|142941516|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71712579|NCT01649869|142941517|SUPERIORITY|||||||0.7068|||||||Fisher Exact|||||||0.7068
71712580|NCT01649869|142941518|SUPERIORITY|||||||0.0752|||||||Fisher Exact|||||||0.0752
71827378|NCT01460342|143159146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.002|TWO_SIDED|95.0|-1.5|-0.3||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 12.|Mixed Models Analysis|||||-0.3|-1.5|0.002
71827379|NCT01460342|143159147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.277|TWO_SIDED|95.0|-0.2|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 4.|Mixed Models Analysis|||||0.1|-0.2|0.277
71827380|NCT01460342|143159147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.17|TWO_SIDED|95.0|-0.3|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 8.|Mixed Models Analysis|||||0.1|-0.3|0.170
71712581|NCT01649869|142941520|SUPERIORITY|||||||0.4823|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.4823
71712582|NCT01649869|142941521|SUPERIORITY|||||||0.0859|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.0859
71712583|NCT01649869|142941522|OTHER|Association of binary outcome and continuous outcome||||||0.8212|||||||Generalized linear model|For binary outcome using generalized estimating equations||||||0.8212
71712584|NCT01649869|142941523|OTHER|Association of binary outcome and continuous outcome and continuous outcome||||||0.8356|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations.||||||0.8356
71712585|NCT01649869|142941524|OTHER|Association of binary outcome and continuous outcome||||||0.7961|||||||Generalized linear model|Generalized linear model for binary outcome using generalized estimating equations||||||0.7961
71712586|NCT01649869|142941525|OTHER|Association of binary outcome and continuous outcome||||||0.8675|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.8675
71712587|NCT01649869|142941526|OTHER|Association of binary outcome and continuous outcome||||||0.9682|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.9682
71766372|NCT04345367|143034375|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|5.9|20.2|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.2|5.9|
71827381|NCT01460342|143159147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.038|TWO_SIDED|95.0|-0.4|0.0||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 12.|Mixed Models Analysis|||||-0.0|-0.4|0.038
71827382|NCT01460342|143159148|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
71712588|NCT01649869|142941527|OTHER|Association of binary outcome and continuous outcome||||||0.6063|||||||Generalized linear model|Generalized linear model for binary outcome||||||0.6063
71712589|NCT01649869|142941528|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71712590|NCT01649869|142941529|SUPERIORITY|||||||0.6043|||||||Fisher Exact|||||||0.6043
71712591|NCT01649869|142941530|SUPERIORITY|||||||0.6513|||||||Fisher Exact|||||||0.6513
71712592|NCT01649869|142941531|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71712593|NCT01649869|142941532|SUPERIORITY|||||||0.0659|||||||Fisher Exact|||||||0.0659
71712594|NCT01649869|142941533|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71712595|NCT03440385|142941540|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8125|TWO_SIDED|95.0|0.66|1.39|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.39|0.66|0.8125
71712596|NCT03440385|142941541|SUPERIORITY||Odds Ratio (OR)|1.13||||0.54|TWO_SIDED|95.0|0.77|1.66|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.66|0.77|0.5400
71712597|NCT03440385|142941542|SUPERIORITY||Odds Ratio (OR)|1.28||||0.2411|TWO_SIDED|95.0|0.85|1.95|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.95|0.85|0.2411
71766373|NCT04345367|143034375|OTHER||Estimate of difference|9.2|||||TWO_SIDED|95.0|2.0|16.4|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.4|2.0|
71712598|NCT03440385|142941543|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7469|TWO_SIDED|95.0|0.67|1.34|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.34|0.67|0.7469
71712599|NCT03440385|142941544|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4255|TWO_SIDED|95.0|0.75|1.97|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.97|0.75|0.4255
71712600|NCT03440385|142941545|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9313|TWO_SIDED|95.0|0.6|1.76|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.76|0.60|0.9313
71712601|NCT03440385|142941546|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4339|TWO_SIDED|95.0|0.7|2.31|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.31|0.70|0.4339
71712602|NCT03440385|142941547|SUPERIORITY||Odds Ratio (OR)|1.3||||0.333|TWO_SIDED|95.0|0.77|2.2|||Cochran-Mantel-Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||2.20|0.77|0.3330
71712603|NCT03440385|142941548|SUPERIORITY||Odds Ratio (OR)|1.04||||0.82|TWO_SIDED|95.0|0.74|1.47|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.47|0.74|0.8200
71712604|NCT03440385|142941549|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7776|TWO_SIDED|95.0|0.71|1.59|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.59|0.71|0.7776
71712605|NCT03440385|142941550|SUPERIORITY||Odds Ratio (OR)|1.39||||0.1187|TWO_SIDED|95.0|0.92|2.11|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.11|0.92|0.1187
71712606|NCT03440385|142941551|SUPERIORITY||Odds Ratio (OR)|1.28||||0.403|TWO_SIDED|95.0|0.72|2.26|||Cochran-Mantel-Haenszel|Odds ratio and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no)||||2.26|0.72|0.4030
71712607|NCT03440385|142941552|SUPERIORITY||Odds Ratio (OR)|0.79||||0.563|TWO_SIDED|95.0|0.35|1.78|||Mantel Haenszel|Odds ratio, and p-value are obtained using the CMH test stratified by corticosteroid use at baseline (yes or no), and prior biologic use (yes or no).||||1.78|0.35|0.5630
71712608|NCT01765400|142941564|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71712609|NCT03978598|142941573|NON_INFERIORITY|We used a 15% difference in our primary outcome for the non-inferiority margin as this is the upper end of the estimated prevalence of lactation failure in the literature and is consistent with previous studies (Neifert 2001, Gurtcheff 2011, Turok 2017).|Risk Difference (RD)|3.7|||||ONE_SIDED|95.0|-16.7|||||||To achieve 80% power with a 1-sided type 1 error of 5% utilizing the Z-test (unpooled), 62 participants would be required in each group, for a total of 124 participants. Accounting for expected loss to follow-up of 20%, we aimed to recruit 149 participants and rounded up to final recruitment goal of 150.|The risk-difference between immediate and standard placement in the modified intention-to-treat analysis (mITT) was -0.6% with a -12.8% lower limit of the 95% confidence interval. In the mITT analysis, 78.3% (54/69) and 78.9% (45/57) of participants were breastfeeding at 8 weeks in the immediate and delayed groups, respectively.||-16.7|
71712610|NCT01425814|142941626|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.219|0.298|||ANCOVA|||||0.298|0.219|<0.0001
71712611|NCT01425814|142941626|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.233|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.194|0.273|||ANCOVA|||||0.273|0.194|<0.0001
71712612|NCT01425814|142941626|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.203|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.164|0.242|||ANCOVA|||||0.242|0.164|<0.0001
71712613|NCT01425814|142941626|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.062|0.141|||ANCOVA|||||0.141|0.062|<0.0001
71712614|NCT01383005|142941649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.001|TWO_SIDED|95.0|0.052|0.494|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from detectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'detectable to undetectable' in the last model of the Wald test.||0.494|0.052|0.001
71712615|NCT01383005|142941649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.279||||0.072|TWO_SIDED|95.0|0.07|1.118|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'viral load change from undetectable to undetectable.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 2 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' in the last model of the Wald test.||1.118|0.070|0.072
71712616|NCT01383005|142941650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.996||||0.025|TWO_SIDED|95.0|0.992|0.999|||Regression, Logistic|Degree of freedom is 1 for the independent variable 'time on LPV/r.'|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score \<5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.||0.999|0.992|0.025
71712617|NCT03243084|142941655|SUPERIORITY|||||||0.319||||||Threshold for significance is \<.05.|ANOVA|||A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables||||.319
71712618|NCT03243084|142941657|SUPERIORITY|||||||0.0488||||||Threshold for significance is \<.05.|Wilcoxon (Mann-Whitney)|||Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index \[(Pre-Post)/(Pre+Post)\]||||.0488
71827383|NCT01460342|143159149|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel|||||||<0.001
71827384|NCT01460342|143159150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.2|0.0|||ANCOVA|||||0.0|-1.2|0.060
71656045|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Specificity|0.98|||||TWO_SIDED|95.0|0.93|0.99|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.99|0.93|
71656046|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.99|||||TWO_SIDED|95.0|0.96|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||1.00|0.96|
71656047|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.77|||||TWO_SIDED|95.0|0.69|0.84|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||0.84|0.69|
71656048|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Sensitivity|0.99|||||TWO_SIDED|95.0|0.97|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.||1.00|0.97|
71656049|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Specificity|0.91|||||TWO_SIDED|95.0|0.83|0.95|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.||0.95|0.83|
71656050|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Positive Predictive Value|0.95|||||TWO_SIDED|95.0|0.9|0.98|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.||0.98|0.90|
71656051|NCT01366443|142830384|SUPERIORITY_OR_OTHER||Negative Predictive Value|0.99|||||TWO_SIDED|95.0|0.94|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.||1.00|0.94|
71656052|NCT00369382|142830387|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||two-sided alpha = 0.05|ANCOVA|Analysis of covariance (ANCOVA) with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.004
71656053|NCT00369382|142830389|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.018
71656054|NCT00369382|142830389|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<.001
71656055|NCT00369382|142830389|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.012
71656056|NCT00369382|142830389|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.072
71656057|NCT00369382|142830389|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.175
71656058|NCT00369382|142830390|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.031
71656059|NCT00369382|142830390|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
71656060|NCT00369382|142830390|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.020
71656061|NCT00369382|142830390|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.151
71656062|NCT00369382|142830390|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.295
71656063|NCT00369382|142830390|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.010
71656064|NCT00369382|142830392|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 4||||0.009
71827385|NCT01689519|143159151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0001|TWO_SIDED|95.0|0.39|0.68||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||0.68|0.39|0.0001
71712619|NCT01137890|142941658|SUPERIORITY||F-value for main effect of Coc dose|24.9|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on VAQ score|||||<0.01
71712620|NCT01137890|142941658|SUPERIORITY||F-value for main effect of Zon dose|0.34||||0.72|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on VAQ score|||||0.72
71712621|NCT01137890|142941658|SUPERIORITY||F-value for main effect of Coc x Zon|0.66||||0.63|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine x Zonisamide interaction on VAQ scores|||||0.63
71712622|NCT01137890|142941659|SUPERIORITY||F-value for main effect of Coc dose|9.91|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on Behavioral Choice measure|||||<0.01
71766374|NCT04345367|143034375|OTHER||Estimate of difference|4.5|||||TWO_SIDED|95.0|-2.8|11.8|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.8|-2.8|
71712623|NCT01137890|142941659|SUPERIORITY||F-value for main effect of Zon dose|0.07||||0.93|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose on Behavioral Choice measure|||||0.93
71712624|NCT01137890|142941659|SUPERIORITY||F-value for main effect of Coc x Zon|0.24||||0.92|TWO_SIDED||||||ANOVA||F-value for main effect of Cocaine dose x Zonisamide dose interaction on Behavioral Choice measure|||||0.92
71712625|NCT01137890|142941660|SUPERIORITY||t-value for main effect of Group|1.51||||0.16|TWO_SIDED|||||Group (Zonisamide vs Placebo)|t-test, 2 sided|||||||0.16
71712626|NCT01137890|142941660|SUPERIORITY|Day (Day 1-39)|t-value for main effect of Day|-3.2||||0.0015|TWO_SIDED||||||t-test, 2 sided|||||||0.0015
71766375|NCT04345367|143034376|OTHER||Estimate of difference|7.1|||||TWO_SIDED|95.0|3.1|11.1|||||Day 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.1|3.1|
71712627|NCT01137890|142941660|SUPERIORITY|Group\*Day interaction|t value for Group x Day interaction|-1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
71712628|NCT01137890|142941661|SUPERIORITY||F-value for main effect of Coc dose|21.1|||<|0.01|TWO_SIDED|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose|||||<0.01
71712629|NCT01137890|142941661|SUPERIORITY||F-value for main effect of Zon dose|0.77||||0.48|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide dose|||||0.48
71712630|NCT01137890|142941661|SUPERIORITY||F-value for the main effect of Zon x Coc|0.93||||0.46|TWO_SIDED||||||ANOVA||F-value for main effect of Zonisamide x Cocaine interaction on drug value (i.e., street value) measurement|||||0.46
71766376|NCT04345367|143034376|OTHER||Estimate of difference|6.5|||||TWO_SIDED|95.0|1.7|11.3|||||Day 3. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.3|1.7|
71712631|NCT02090764|142941662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Chi-squared|||The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.||||0.001
71712632|NCT02384421|142941663|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71766377|NCT04345367|143034376|OTHER||Estimate of difference|11.4|||||TWO_SIDED|95.0|6.0|16.8|||||Day 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||16.8|6.0|
71766378|NCT04345367|143034376|OTHER||Estimate of difference|14.5|||||TWO_SIDED|95.0|8.8|20.3|||||Day 5. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.3|8.8|
71712633|NCT02384421|142941664|SUPERIORITY|||||||0.0064|||||||t-test, 2 sided|||||||0.0064
71712634|NCT02384421|142941665|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71712635|NCT02384421|142941666|SUPERIORITY|||||||0.25|||||||Wilcoxon Signed-Rank Test|||||||0.25
71712636|NCT02384421|142941667|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71712637|NCT02384421|142941668|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71712638|NCT02300233|142941669|SUPERIORITY||Difference in Least Squares Mean (LSM)|-70.3|||<|0.0001|TWO_SIDED|95.0|-85.4|-55.3|||ANCOVA|||||-55.3|-85.4|<0.0001
71712639|NCT02300233|142941670|SUPERIORITY||Difference in LSM|-943.0|||<|0.0001|TWO_SIDED|95.0|-1197.0|-689.0|||ANCOVA|||||-689|-1197|<0.0001
71712640|NCT02300233|142941671|SUPERIORITY||Odds Ratio (OR)|96.02|||<|0.0001|TWO_SIDED|95.0|19.71|467.79|||Regression, Logistic|||||467.79|19.71|<0.0001
71712641|NCT02300233|142941672|SUPERIORITY||Difference in LSM|56.8|||<|0.0001|TWO_SIDED|95.0|45.1|68.6|||ANCOVA|||||68.6|45.1|<0.0001
71712642|NCT02300233|142941673|SUPERIORITY||Odds Ratio (OR)|14.93||||0.0474|TWO_SIDED|95.0|1.03|215.88|||Regression, Logistic|||||215.88|1.03|0.0474
71712643|NCT04380142|142941747|SUPERIORITY||Least Squares (LS) Mean of Difference|1.75|STANDARD_ERROR_OF_MEAN|0.65||0.0083|TWO_SIDED|95.0|0.46|3.05||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||3.05|0.46|0.0083
71712644|NCT04380142|142941748|SUPERIORITY||LS Mean of Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.63||0.0054|TWO_SIDED|95.0|-3.03|-0.54||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||-0.54|-3.03|0.0054
71712645|NCT04380142|142941749|SUPERIORITY||LS Mean of Difference|-1.58|STANDARD_ERROR_OF_MEAN|1.05||0.1318|TWO_SIDED|95.0|-3.65|0.48||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|mixed model repeated measures|||||0.48|-3.65|0.1318
71766379|NCT04345367|143034376|OTHER||Estimate of difference|12.9|||||TWO_SIDED|95.0|6.9|19.0|||||Day 6. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||19.0|6.9|
71827386|NCT01689519|143159151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.72||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Efficacy Analysis: 16 January 2015||0.72|0.46|<0.0001
71827387|NCT01689519|143159151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Extended 5-Year Analysis: 21 July 2019||0.79|0.53|<0.0001
71827388|NCT01689519|143159152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.645||||0.0463|TWO_SIDED|95.0|0.42|1.0||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Primary Analysis 9 May 2014||1.00|0.42|0.0463
71827389|NCT01689519|143159152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.0034|TWO_SIDED|95.0|0.49|0.87||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Post hoc Analysis 16 January 2015||0.87|0.49|0.0034
71766380|NCT04345367|143034376|OTHER||Estimate of difference|19.9|||||TWO_SIDED|95.0|13.8|26.0|||||Day 7. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.0|13.8|
71766381|NCT04345367|143034376|OTHER||Estimate of difference|22.1|||||TWO_SIDED|95.0|15.9|28.3|||||Day 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.3|15.9|
71766382|NCT04345367|143034376|OTHER||Estimate of difference|21.7|||||TWO_SIDED|95.0|15.2|28.1|||||Day 9. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||28.1|15.2|
71766383|NCT04345367|143034376|OTHER||Estimate of other|21.3|||||TWO_SIDED|95.0|14.7|27.9|||||Day 10. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.7|
71766384|NCT04345367|143034376|OTHER||Estimate of difference|20.0|||||TWO_SIDED|95.0|13.3|26.6|||||Day 11. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||26.6|13.3|
71766385|NCT04345367|143034376|OTHER||Estimate of difference|21.3|||||TWO_SIDED|95.0|14.6|27.9|||||Day 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||27.9|14.6|
71766386|NCT04345367|143034376|OTHER||Estimate of difference|22.5|||||TWO_SIDED|95.0|15.8|29.2|||||Day 13. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.8|
71766387|NCT04345367|143034376|OTHER||Estimate of difference|22.4|||||TWO_SIDED|95.0|15.6|29.2|||||Day 14. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.2|15.6|
71766388|NCT04345367|143034376|OTHER||Estimate of difference|22.9|||||TWO_SIDED|95.0|16.0|29.9|||||Day 15. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||29.9|16.0|
71766389|NCT04345367|143034377|OTHER||Estimate of difference|17.3|||||TWO_SIDED|95.0|10.1|24.5|||||Week 4. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||24.5|10.1|
71766390|NCT04345367|143034377|OTHER||Estimate of difference|13.0|||||TWO_SIDED|95.0|6.0|20.1|||||Week 8. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|6.0|
71766391|NCT04345367|143034377|OTHER||Estimate of difference|4.4|||||TWO_SIDED|95.0|-2.5|11.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.4|-2.5|
71766392|NCT04345367|143034377|OTHER||Estimate of difference|3.6|||||TWO_SIDED|95.0|-3.4|10.5|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||10.5|-3.4|
71766393|NCT04345367|143034377|OTHER||Estimate of difference|2.0|||||TWO_SIDED|95.0|-4.9|9.0|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.0|-4.9|
71766394|NCT04345367|143034377|OTHER||Estimate of difference|5.0|||||TWO_SIDED|95.0|-1.9|11.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||11.9|-1.9|
71766395|NCT04345367|143034379|OTHER||Least square mean difference|-9.3|||||TWO_SIDED|95.0|-14.0|-4.6|||||Week 2. Analysis was performed using Mixed Model Repeated Measure (MMRM) with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.6|-14.0|
71766396|NCT04345367|143034379|OTHER||Least square mean difference|-12.5|||||TWO_SIDED|95.0|-17.4|-7.6|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-17.4|
71766397|NCT04345367|143034379|OTHER||Least square mean difference|-11.1|||||TWO_SIDED|95.0|-15.6|-6.6|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.6|-15.6|
71766398|NCT04345367|143034379|OTHER||Least square mean difference|-9.4|||||TWO_SIDED|95.0|-13.7|-5.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-5.1|-13.7|
71886765|NCT00523991|143293836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.961||95.0|-6.52|6.84||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.84|-6.52|0.961
71827390|NCT01689519|143159152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank|||Final Analysis 28 August 2015||0.90|0.55|0.0050
71656065|NCT00369382|142830392|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 16||||<0.001
71656066|NCT00369382|142830392|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 24||||0.002
71656067|NCT00369382|142830392|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 32||||0.030
71656068|NCT00369382|142830392|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 40||||0.121
71656069|NCT00369382|142830392|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 52||||0.001
71656070|NCT00369382|142830394|SUPERIORITY_OR_OTHER||slope difference (CNI - SRL)|-2.311||||0.126|TWO_SIDED|95.0|-5.282|0.66||alpha is unadjusted|Random coefficient model||Random coefficient model with each participant's creatinine clearance function of time on treatment; intra-subject regression coefficients considered random.|||0.660|-5.282|0.126
71656071|NCT00369382|142830396|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||For-cause Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.206
71656072|NCT00369382|142830396|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED|||||alpha is unadjusted|Fisher Exact|||Standard of Care Biopsy-Confirmed Acute Rejection compared between treatment groups||||0.476
71656073|NCT01673698|142830402|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||t-test, 1 sided|||||||0.0041
71656074|NCT01673698|142830403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 1 sided|||||||<0.0001
71656075|NCT01673698|142830404|SUPERIORITY_OR_OTHER|||||||0.561|TWO_SIDED||||||Chi-squared|||||||0.5610
71656076|NCT00507546|142830405|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED|95.0|||||Friedman|||||||0.70
71656077|NCT00507546|142830406|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Friedman|||||||0.35
71656078|NCT00609466|142830423|SUPERIORITY_OR_OTHER||Least square mean|70.8|||<|0.0001||95.0|35.9|105.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||105.6|35.9|<0.0001
71656079|NCT00609466|142830424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Test for time (in hours) to first rescue medication use. No multiplicity adjustment.|Log Rank|Adjusted for site||||||<0.0001
71656080|NCT00609466|142830425|SUPERIORITY_OR_OTHER||Least square mean|37.5|||<|0.0001||95.0|22.7|52.2||No multiplicity adjustment used|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.2|22.7|<0.0001
71656081|NCT00609466|142830426|SUPERIORITY_OR_OTHER||Least square means|9.9|||<|0.0001||95.0|6.2|13.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||13.6|6.2|<0.0001
71656082|NCT00609466|142830427|SUPERIORITY_OR_OTHER||Least square mean|20.6|||<|0.0001||95.0|13.2|28.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||28.0|13.2|<0.0001
71656083|NCT00609466|142830428|SUPERIORITY_OR_OTHER||Least square mean|36.4|||<|0.0001||95.0|20.7|52.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||52.0|20.7|<0.0001
71656084|NCT00609466|142830429|SUPERIORITY_OR_OTHER||Least square means|108.2||||0.0002||95.0|51.9|164.5||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.||164.5|51.9|0.0002
71656085|NCT03512262|142830430|SUPERIORITY||Least Squares (LSM) Means Difference|7.3165|||<|0.0001|TWO_SIDED|99.0|5.0668|9.5663||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||9.5663|5.0668|<0.0001
71656086|NCT03512262|142830431|SUPERIORITY||LSM Difference|2.1209|||<|0.0001|TWO_SIDED|99.0|0.9948|3.2469||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||3.2469|0.9948|<0.0001
71656087|NCT03512262|142830432|SUPERIORITY||LSM Difference|2.8221|||<|0.0001|TWO_SIDED|99.0|1.3972|4.2471||Significance level of 0.01.|ANCOVA|Missing values were imputed using a multiple imputation method.||||4.2471|1.3972|<0.0001
71656088|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.308|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.308
71656089|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.415|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.415
71656090|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.335|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.335
71656091|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.120
71656092|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.061|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.061
71656093|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.031
71656094|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.131
71656095|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.202|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.202
71656096|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.484|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.484
71656097|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.047
71656098|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.285|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.285
71656099|NCT01195272|142830460|SUPERIORITY_OR_OTHER|||||||0.315|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.315
71827391|NCT01689519|143159153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.85|||<|0.0001|TWO_SIDED|95.0|14.13|31.58|||Chi-squared|||Primary Analysis: 9 May 2014||31.58|14.13|<0.0001
71712646|NCT04380142|142941750|SUPERIORITY||Odds Ratio (OR)|0.12|STANDARD_ERROR_OF_MEAN|0.49|<=|0.001|TWO_SIDED|95.0|0.04|0.31||The generalized linear mixed model: status = treatment country visit baseline treatment\*visit. The unstructured variance-covariance structure is used.|generalized linear mixed model|||||0.31|0.04|<=0.001
71827392|NCT01689519|143159153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.6|||<|0.0001|TWO_SIDED|95.0|11.0|28.3|||Chi-squared|||Post hoc Efficacy Analysis: 16 January 2015||28.3|11.0|<0.0001
71827393|NCT01689519|143159153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|||<|0.0001|TWO_SIDED|95.0|11.4|28.7|||Chi-squared|||Extended 5-Year Analysis: 21 July 2019||28.70|11.40|<0.0001
71656100|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.288|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2||||0.288
71656101|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.318|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2||||0.318
71656102|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3||||0.400
71656103|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.317|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2||||0.317
71656104|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3||||0.137
71656105|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5||||0.052
71656106|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.354|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2||||0.354
71656107|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.266|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2||||0.266
71656108|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.378|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3||||0.378
71656109|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.422|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2||||0.422
71656110|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.444|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3||||0.444
71656111|NCT01195272|142830461|SUPERIORITY_OR_OTHER|||||||0.345|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5||||0.345
71656112|NCT01195272|142830462|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||Visit 3 versus Visit 2||||0.39
71656113|NCT01195272|142830462|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Visit 5 versus Visit 3||||0.08
71656114|NCT01195272|142830462|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
71656115|NCT01195272|142830463|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
71656116|NCT01195272|142830463|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||Visit 5 versus Visit 2||||0.30
71656117|NCT01195272|142830463|SUPERIORITY_OR_OTHER|||||||0.34|||||||ANOVA|||Visit 5 versus Visit 3||||0.34
71656118|NCT01195272|142830464|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
71656119|NCT01195272|142830464|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 2||||0.44
71656120|NCT01195272|142830464|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANOVA|||Visit 5 versus Visit 3||||0.23
71656121|NCT01195272|142830465|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2||||0.22
71656122|NCT01195272|142830465|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Visit 5 versus Visit 2||||0.46
71656123|NCT01195272|142830465|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||Visit 5 versus Visit 3||||0.24
71656124|NCT01195272|142830466|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Visit 3 versus Visit 2||||0.05
71656125|NCT01195272|142830466|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||Visit 5 versus Visit 2||||0.01
71656126|NCT01195272|142830466|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3||||0.18
71656127|NCT01195272|142830467|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2||||0.48
71656128|NCT01195272|142830467|SUPERIORITY_OR_OTHER|||||||0.43|||||||ANOVA|||Visit 5 versus Visit 2||||0.43
71656129|NCT01195272|142830467|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 3||||0.44
71656130|NCT01195272|142830468|SUPERIORITY_OR_OTHER|||||||0.313|||||||ANOVA|||Visit 3 versus Visit 2||||0.313
71656131|NCT01195272|142830468|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||Visit 5 versus Visit 2||||0.083
71656132|NCT01195272|142830468|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANOVA|||Visit 5 versus Visit 3||||0.092
71656133|NCT01195272|142830468|SUPERIORITY_OR_OTHER|||||||0.145|||||||ANOVA|||Visit 8 versus Visit 2||||0.145
71656134|NCT01195272|142830468|SUPERIORITY_OR_OTHER|||||||0.398|||||||ANOVA|||Visit 8 versus Visit 3||||0.398
71712647|NCT04380142|142941751|SUPERIORITY||Odds Ratio (OR)|1.81|STANDARD_ERROR_OF_MEAN|0.68||0.0091|TWO_SIDED|95.0|0.46|3.16|||generalized linear mixed model|||||3.16|0.46|0.0091
71712648|NCT04380142|142941752|SUPERIORITY||LS Mean of Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.32|<=|0.001|TWO_SIDED|95.0|-8.03|-2.78||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-2.78|-8.03|<=0.001
71712649|NCT04380142|142941753|SUPERIORITY||Least Squares (LS) Mean of Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.04||0.047|TWO_SIDED|95.0|-8.14|-0.05||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||-0.05|-8.14|0.0470
71712650|NCT04380142|142941754|SUPERIORITY||LS Mean of Difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0566|TWO_SIDED|95.0|-0.001|0.1||ANCOVA model including effects for treatment, country, and baseline.|ANCOVA|||||0.100|-0.001|0.0566
71712651|NCT04380142|142941755|SUPERIORITY||LS Mean of Difference|1.72|STANDARD_ERROR_OF_MEAN|0.72||0.0184|TWO_SIDED|95.0|0.3|3.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||3.15|0.30|0.0184
71712652|NCT04380142|142941756|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.69||0.7989|TWO_SIDED|95.0|-1.2|1.55||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.55|-1.20|0.7989
71712653|NCT04380142|142941757|SUPERIORITY||LS Mean of Difference|-2.73|STANDARD_ERROR_OF_MEAN|1.96||0.1656|TWO_SIDED|95.0|-6.61|1.15||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.15|-6.61|0.1656
71766399|NCT04345367|143034379|OTHER||Least square mean difference|-6.9|||||TWO_SIDED|95.0|-10.9|-2.9|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-2.9|-10.9|
71766400|NCT04345367|143034379|OTHER||Least square mean difference|-5.3|||||TWO_SIDED|95.0|-9.0|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-9.0|
71766401|NCT04345367|143034379|OTHER||Least square mean difference|-3.4|||||TWO_SIDED|95.0|-7.1|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-7.1|
71766402|NCT04345367|143034380|OTHER||Least square mean difference|-11.0|||||TWO_SIDED|95.0|-14.5|-7.6|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-7.6|-14.5|
71766403|NCT04345367|143034380|OTHER||Least square mean difference|-12.8|||||TWO_SIDED|95.0|-16.0|-9.5|||||Week 4. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-9.5|-16.0|
71766404|NCT04345367|143034380|OTHER||Least square mean difference|-10.2|||||TWO_SIDED|95.0|-13.6|-6.8|||||Week 8. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-6.8|-13.6|
71766405|NCT04345367|143034380|OTHER||Least square mean difference|-7.3|||||TWO_SIDED|95.0|-10.5|-4.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-4.1|-10.5|
71766406|NCT04345367|143034380|OTHER||Least square mean difference|-6.1|||||TWO_SIDED|95.0|-9.3|-3.0|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-3.0|-9.3|
71766407|NCT04345367|143034380|OTHER||Least square mean difference|-4.9|||||TWO_SIDED|95.0|-8.2|-1.7|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.7|-8.2|
71766408|NCT04345367|143034380|OTHER||Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.6|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-6.6|
71766409|NCT04345367|143034381|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.4|
71766410|NCT04345367|143034381|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.3|
71766411|NCT04345367|143034381|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.3|
71766412|NCT04345367|143034382|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.3|-0.3|
71766413|NCT04345367|143034382|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-0.2|
71656135|NCT01195272|142830468|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANOVA|||Visit 8 versus Visit 5||||0.138
71766414|NCT04345367|143034382|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
71766415|NCT04345367|143034383|OTHER||Least square mean difference|-2.0|||||TWO_SIDED|95.0|-2.6|-1.3|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.3|-2.6|
71766416|NCT04345367|143034383|OTHER||Least square mean difference|-1.0|||||TWO_SIDED|95.0|-1.6|-0.4|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-1.6|
71766417|NCT04345367|143034383|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-1.4|-0.2|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.2|-1.4|
71766418|NCT04345367|143034383|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-1.2|
71766419|NCT04345367|143034383|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-1.0|
71766420|NCT04345367|143034384|OTHER||Least square mean difference|0.818|||||TWO_SIDED|95.0|-1.22|2.856|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.856|-1.220|
71766421|NCT04345367|143034384|OTHER||Least square mean difference|2.093|||||TWO_SIDED|95.0|-0.081|4.267|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||4.267|-0.081|
71656136|NCT01195272|142830469|SUPERIORITY_OR_OTHER|||||||0.467|||||||ANOVA|||Visit 3 versus Visit 2||||0.467
71827394|NCT03525119|143159165|NON_INFERIORITY|As per predefined criteria in protocol the non-inferiority was established only between group 1 and group 3. Non-inferiority of HAV+TDV to HAV was established if the upper bound of the 95% CI was less than 10%.|Seroprotection Rate Difference|-1.68|||||TWO_SIDED|95.0|-8.91|4.28||||||||4.28|-8.91|
71766422|NCT04345367|143034384|OTHER||Least square mean difference|-0.816|||||TWO_SIDED|95.0|-2.914|1.281|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.281|-2.914|
71766423|NCT04345367|143034385|OTHER||Least square mean difference|-1.6|||||TWO_SIDED|95.0|-2.5|-0.7|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.7|-2.5|
71766424|NCT04345367|143034385|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-2.2|-0.5|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-2.2|
71766425|NCT04345367|143034385|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-1.3|0.5|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-1.3|
71766426|NCT04345367|143034386|OTHER||Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6|||||Quantity of hours slept: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.6|-0.1|
71827395|NCT05046132|143159180|OTHER||Mean of Placebo-corrected CHFB|3.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|1.23|6.17||||||"The C-QTc analysis was performed with a non-linear model.~The mean of placebo-corrected CHFB in QTcF at maximum concentration (Cmax) geometric mean of therapeutic dose (3 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods."||6.17|1.23|
71827396|NCT05046132|143159181|OTHER||Mean of Placebo-corrected CHFB|4.67|||||TWO_SIDED|90.0|1.7|7.64||||||The C-QTc analysis was performed with a non-linear model. The mean of placebo-corrected CHFB in QTcF at Cmax geometric mean of therapeutic dose (7 mg QD) was estimated with bias-corrected 90% CI by nonparametric bootstrap methods.||7.64|1.70|
71766427|NCT04345367|143034386|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
71766428|NCT04345367|143034386|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Quantity of hours slept: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-0.2|
71766429|NCT04345367|143034386|OTHER||Least square mean difference|1.2|||||TWO_SIDED|95.0|-0.9|3.4|||||Short of Breath or Headache score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-0.9|
71766430|NCT04345367|143034386|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-2.0|2.2|||||Short of Breath or Headache score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.2|-2.0|
71656137|NCT01195272|142830469|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Visit 5 versus Visit 2||||0.250
71766431|NCT04345367|143034386|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-1.5|2.6|||||Short of Breath or Headache score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||2.6|-1.5|
71766432|NCT04345367|143034386|OTHER||Least square mean difference|-1.8|||||TWO_SIDED|95.0|-4.2|0.5|||||Snoring score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.5|-4.2|
71766433|NCT04345367|143034386|OTHER||Least square mean difference|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Snoring score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.5|-3.3|
71766434|NCT04345367|143034386|OTHER||Least square mean difference|0.8|||||TWO_SIDED|95.0|-1.7|3.4|||||Snoring score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.7|
71766435|NCT04345367|143034386|OTHER||Least square mean difference|-4.1|||||TWO_SIDED|95.0|-6.6|-1.6|||||Sleep disturbance score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.6|-6.6|
71766436|NCT04345367|143034386|OTHER||Least square mean difference|-3.8|||||TWO_SIDED|95.0|-6.2|-1.4|||||Sleep disturbance score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.4|-6.2|
71827397|NCT05046132|143159182|OTHER||LS Mean|2.5|||||TWO_SIDED|90.0|-0.6|5.6||||||Pre-dose||5.6|-0.6|
71827398|NCT05046132|143159182|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-3.0|3.1||||||0.5 hr Post dose||3.1|-3.0|
71827399|NCT05046132|143159182|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.0||||||1 hr Post dose||3.0|-2.8|
71827400|NCT05046132|143159182|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.8|5.1||||||1.5 hr Post dose||5.1|-1.8|
71827401|NCT05046132|143159182|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.8|4.1||||||2 hr Post dose||4.1|-2.8|
71827402|NCT05046132|143159182|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.9|3.4||||||2.5 hr Post dose||3.4|-2.9|
71827403|NCT05046132|143159182|OTHER||LS Mean|2.2|||||TWO_SIDED|90.0|-1.4|5.7||||||3 hr Post dose||5.7|-1.4|
71827404|NCT05046132|143159182|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.9|2.7||||||4 hr Post dose||2.7|-2.9|
71886766|NCT00523991|143293837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.158||95.0|-11.73|1.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||1.94|-11.73|0.158
71712654|NCT04380142|142941758|SUPERIORITY||LS Mean of Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.65||0.1347|TWO_SIDED|95.0|-12.71|1.73||The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.|Repeated measures model|||||1.73|-12.71|0.1347
71712655|NCT02908178|142941765|OTHER||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|99.0|1.18|1.63||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.||1.63|1.18|<.001
71712656|NCT02908178|142941765|OTHER||Odds Ratio (OR)|4.45|||<|0.001|TWO_SIDED|99.0|2.27|8.75||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.||8.75|2.27|<.001
71712657|NCT02908178|142941765|OTHER||Odds Ratio (OR)|1.24|||<|0.001|TWO_SIDED|99.0|1.0|1.54||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.||1.54|1.00|<.001
71712658|NCT02908178|142941765|OTHER||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|99.0|1.03|1.91||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.||1.91|1.03|<.001
71712659|NCT02908178|142941765|OTHER||Odds Ratio (OR)|1.31||||0.003|TWO_SIDED|99.0|1.04|1.65||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.||1.65|1.04|.003
71712660|NCT02908178|142941766|OTHER||||||<|0.001||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.||||<.001
71712661|NCT02908178|142941767|OTHER|||||||0.48||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.||||.48
71712662|NCT02908178|142941768|OTHER||Hazard Ratio (HR)|0.88|||<|0.001|TWO_SIDED|99.0|0.73|1.05||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.||1.05|0.73|<.001
71712663|NCT02908178|142941769|OTHER||Hazard Ratio (HR)|1.09||||0.207|TWO_SIDED|99.0|1.0|1.2||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.||1.20|1.00|0.207
71712664|NCT02908178|142941769|OTHER||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|99.0|1.12|2.11||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.||2.11|1.12|<.001
71712665|NCT02908178|142941769|OTHER||Hazard Ratio (HR)|0.98||||0.113|TWO_SIDED|99.0|0.87|1.1||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.||1.10|0.87|0.113
71712666|NCT02908178|142941769|OTHER||Hazard Ratio (HR)|1.21||||0.01|TWO_SIDED|99.0|0.93|1.58||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.||1.58|0.93|0.010
71712667|NCT02908178|142941769|OTHER||Hazard Ratio (HR)|1.1||||0.029|TWO_SIDED|99.0|0.98|1.25||P-value is unadjusted. Threshold for statistical significance is 0.01|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.||1.25|0.98|0.029
71766437|NCT04345367|143034386|OTHER||Least square mean difference|-1.7|||||TWO_SIDED|95.0|-4.1|0.7|||||Sleep disturbance score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-4.1|
71827405|NCT05046132|143159182|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||5 hr Post dose||2.7|-3.1|
71827406|NCT05046132|143159182|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.8|2.3||||||6 hr Post dose||2.3|-3.8|
71827407|NCT05046132|143159182|OTHER||LS Mean|-2.8|||||TWO_SIDED|90.0|-5.5|-0.1||||||7 hr Post dose||-0.1|-5.5|
71827408|NCT05046132|143159182|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.5|1.3||||||8 hr Post dose||1.3|-4.5|
71827409|NCT05046132|143159182|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.5|3.0||||||9 hr Post dose||3.0|-2.5|
71656138|NCT01195272|142830469|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Visit 5 versus Visit 3||||0.060
71827410|NCT05046132|143159182|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.3|2.7||||||10 hr Post dose||2.7|-2.3|
71827411|NCT05046132|143159182|OTHER||LS Mean|-3.0|||||TWO_SIDED|90.0|-5.9|-0.1||||||12 hr Post dose||-0.1|-5.9|
71827412|NCT05046132|143159182|OTHER||LS Mean|-2.0|||||TWO_SIDED|90.0|-5.1|1.0||||||16 hr Post dose||1.0|-5.1|
71827413|NCT05046132|143159182|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-1.6|3.8||||||24 hr Post dose||3.8|-1.6|
71827414|NCT05046132|143159182|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.7|4.5||||||Pre-dose||4.5|-1.7|
71656139|NCT01195272|142830469|SUPERIORITY_OR_OTHER|||||||0.149|||||||ANOVA|||Visit 8 versus Visit 2||||0.149
71656140|NCT01195272|142830469|SUPERIORITY_OR_OTHER|||||||0.061|||||||ANOVA|||Visit 8 versus Visit 3||||0.061
71656141|NCT01195272|142830469|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANOVA|||Visit 8 versus Visit 5||||0.047
71656142|NCT01195272|142830470|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANOVA|||Visit 3 versus Visit 2||||0.169
71656143|NCT01195272|142830470|SUPERIORITY_OR_OTHER|||||||0.165|||||||ANOVA|||Visit 5 versus Visit 2||||0.165
71656144|NCT01195272|142830470|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANOVA|||Visit 5 versus Visit 3||||0.471
71656145|NCT01195272|142830470|SUPERIORITY_OR_OTHER|||||||0.243|||||||ANOVA|||Visit 8 versus Visit 2||||0.243
71656146|NCT01195272|142830470|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANOVA|||Visit 8 versus Visit 3||||0.396
71656147|NCT01195272|142830470|SUPERIORITY_OR_OTHER|||||||0.375|||||||ANOVA|||Visit 8 versus Visit 5||||0.375
71656148|NCT01195272|142830471|SUPERIORITY_OR_OTHER|||||||0.496|||||||ANOVA|||Visit 3 versus Visit 2||||0.496
71656149|NCT01195272|142830471|SUPERIORITY_OR_OTHER|||||||0.122|||||||ANOVA|||Visit 5 versus Visit 2||||0.122
71656150|NCT01195272|142830471|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Visit 5 versus Visit 3||||0.070
71656151|NCT01195272|142830471|SUPERIORITY_OR_OTHER|||||||0.135|||||||ANOVA|||Visit 8 versus Visit 2||||0.135
71656152|NCT01195272|142830471|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANOVA|||Visit 8 versus Visit 3||||0.082
71656153|NCT01195272|142830471|SUPERIORITY_OR_OTHER|||||||0.461|||||||ANOVA|||Visit 8 versus Visit 5||||0.461
71656154|NCT04319718|142830483|OTHER|||||||0.025|||||||Fisher Exact|||||||.025
71656155|NCT04319718|142830484|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
71656156|NCT04319718|142830488|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||.67
71656157|NCT04319718|142830489|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||.51
71656158|NCT04319718|142830490|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||.09
71656159|NCT04319718|142830491|OTHER|||||||0.65|||||||Mixed Models Analysis|||||||.65
71656160|NCT04319718|142830491|OTHER|||||||0.24|||||||Mixed Models Analysis|||||||.24
71656161|NCT04319718|142830491|OTHER|||||||0.27|||||||Mixed Models Analysis|||||||.27
71656162|NCT04551911|142830573|OTHER|||||||0.7856|||||||Regression, Logistic|Logistic regression with treatment as the main effect, and baseline aggregate symptom score, baseline 25D level, and body weight as covariates||||||0.7856
71656163|NCT01030341|142830581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<50 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
71656164|NCT01030341|142830581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (\<70 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
71827415|NCT05046132|143159182|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.7||||||0.5 hr Post dose||4.7|-1.4|
71827416|NCT05046132|143159182|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||1 hr Post dose||4.8|-1.0|
71827417|NCT05046132|143159182|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.9|6.0||||||1.5 hr Post dose||6.0|-0.9|
71827418|NCT05046132|143159182|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-2.1|4.8||||||2 hr Post dose||4.8|-2.1|
71827419|NCT05046132|143159182|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.4|4.9||||||2.5 hr Post dose||4.9|-1.4|
71827420|NCT05046132|143159182|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.9|5.1||||||3 hr Post dose||5.1|-1.9|
71827421|NCT05046132|143159182|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-1.4|4.2||||||4 hr Post dose||4.2|-1.4|
71827422|NCT05046132|143159182|OTHER||LS Mean|2.7|||||TWO_SIDED|90.0|-0.2|5.7||||||5 hr Post dose||5.7|-0.2|
71827423|NCT05046132|143159182|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|1.4|7.5||||||6 hr Post dose||7.5|1.4|
71827424|NCT05046132|143159182|OTHER||LS Mean|2.8|||||TWO_SIDED|90.0|0.1|5.5||||||7 hr Post dose||5.5|0.1|
71827425|NCT05046132|143159182|OTHER||LS Mean|4.1|||||TWO_SIDED|90.0|1.2|7.0||||||8 hr Post dose||7.0|1.2|
71827426|NCT05046132|143159182|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.8|6.3||||||9 hr Post dose||6.3|0.8|
71827427|NCT05046132|143159182|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|0.8|5.8||||||10 hr Post dose||5.8|0.8|
71827428|NCT05046132|143159182|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-0.3|5.5||||||12 hr Post dose||5.5|-0.3|
71827429|NCT05046132|143159182|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.7|3.4||||||16 hr Post dose||3.4|-2.7|
71827430|NCT05046132|143159182|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.0|4.4||||||24 hr Post dose||4.4|-1.0|
71827431|NCT05046132|143159183|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.8|3.4||||||Pre dose||3.4|-2.8|
71827432|NCT05046132|143159183|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.3|1.0||||||0.5 hr Post dose||1.0|-5.3|
71827433|NCT05046132|143159183|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.4||||||1 hr Post dose||1.4|-4.7|
71827434|NCT05046132|143159183|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.3|1.0||||||1.5 hr Post dose||1.0|-5.3|
71827435|NCT05046132|143159183|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.3||||||2 hr Post dose||-0.3|-6.3|
71827436|NCT05046132|143159183|OTHER||LS Mean|-1.2|||||TWO_SIDED|90.0|-4.1|1.7||||||2.5 hr Post dose||1.7|-4.1|
71827437|NCT05046132|143159183|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-4.2|1.7||||||3 hr Post dose||1.7|-4.2|
71827438|NCT05046132|143159183|OTHER||LS Mean|-0.6|||||TWO_SIDED|90.0|-3.6|2.5||||||4 hr Post dose||2.5|-3.6|
71712668|NCT02908178|142941770|OTHER||Hazard Ratio (HR)|1.13||||0.861|TWO_SIDED|99.0|0.54|2.35||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.||2.35|0.54|0.861
71712669|NCT02908178|142941771|OTHER||Hazard Ratio (HR)|1.03||||0.603|TWO_SIDED|99.0|0.71|1.51||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.||1.51|0.71|0.603
71712670|NCT02908178|142941772|OTHER||Hazard Ratio (HR)|1.17||||0.62|TWO_SIDED|99.0|0.81|1.69||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.||1.69|0.81|0.620
71712671|NCT04716894|142941773|OTHER||adjusted geometric mean (gMean) ratio(%)|197.77|||||TWO_SIDED|90.0|187.9|208.15|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 7.0.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||208.15|187.90|
71712672|NCT04716894|142941774|OTHER||adjusted geometric mean (gMean) ratio(%)|143.38|||||TWO_SIDED|90.0|121.92|168.6|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 22.1.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||168.60|121.92|
71712673|NCT04716894|142941775|OTHER||adjusted geometric mean (gMean) ratio(%)|201.64|||||TWO_SIDED|90.0|192.23|211.52|||||Ratio (%) = T/R\*100. Intra-individual geometric coefficient of variation (gCV) = 6.5.|Relative bioavailability. Model used was an analysis of variance (ANOVA) model on the logarithmic scale. Data were log-transformed (natural logarithm) prior to fitting the ANOVA model. The effect 'subjects' was considered as random effect, whereas 'treatment' was considered as fixed effect.||211.52|192.23|
71712674|NCT03773484|142941776|OTHER||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.011||0.43|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||Pre post comparison for Opioid Naïve patients||0.01|-0.03|0.43
71712675|NCT03773484|142941776|OTHER||Slope|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.24|TWO_SIDED|95.0|-0.051|0.013|||Mixed Models Analysis|||Pre-post comparison for at-risk for long term use patients||0.013|-0.051|0.24
71712676|NCT03211416|142941804|SUPERIORITY||Response Rate|0.296|||||TWO_SIDED|95.0|0.151|0.483||||||||0.483|0.151|
71712677|NCT03211416|142941807|SUPERIORITY|||||||0.4||||||Significance level of 0.05.|Two-sided, one-sample t-test|||The null hypothesis is that the mean ratio of T effect cells (post / pre) is equal to 1 (no change).||||0.40
71712678|NCT02302222|142941815|SUPERIORITY||Risk Difference (RD)|0.113||||0.1981|TWO_SIDED|95.0|-0.016|0.243|||Fisher Exact|||||0.243|-0.016|0.1981
71712679|NCT03781570|142941839|SUPERIORITY||Mean Difference (Final Values)|-0.0544|STANDARD_ERROR_OF_MEAN|0.00517|<|0.001|TWO_SIDED|95.0|-0.0648|-0.0441|||Mixed Models Analysis|Satterthwaite's method was used to estimate degrees of freedom for the mixed effects model.||Comparing placebo vs. control for thermal pain ratings with mixed effects models controlling for the stimulus intensity and the familial structure of the data.||-0.0441|-0.0648|<0.001
71712680|NCT01107496|142941841|SUPERIORITY||Median Difference (Net)|6.0||||0.0414|TWO_SIDED|95.0|1.0|12.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||12.00|1.00|0.0414
71712681|NCT01107496|142941842|SUPERIORITY||Median Difference (Net)|3.0||||0.0803|TWO_SIDED|95.0|0.0|7.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 1 data.||7.00|0.00|0.0803
71827439|NCT05046132|143159183|OTHER||LS Mean|-1.0|||||TWO_SIDED|95.0|-4.1|2.1||||||5 hr Post dose||2.1|-4.1|
71827440|NCT05046132|143159183|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.7|3.5||||||6 hr Post dose||3.5|-2.7|
71827441|NCT05046132|143159183|OTHER||LS Mean|-2.5|||||TWO_SIDED|90.0|-5.5|0.5||||||7 hr Post dose||0.5|-5.5|
71827442|NCT05046132|143159183|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.2|0.8||||||8 hr Post dose||0.8|-5.2|
71827443|NCT05046132|143159183|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-4.3|2.6||||||9 hr Post dose||2.6|-4.3|
71827444|NCT05046132|143159183|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.6|3.2||||||10 hr Post dose||3.2|-3.6|
71827445|NCT05046132|143159183|OTHER||LS Mean|-2.2|||||TWO_SIDED|90.0|-5.5|1.0||||||12 hr Post dose||1.0|-5.5|
71827446|NCT05046132|143159183|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.4|1.7||||||16 hr Post dose||1.7|-5.4|
71827447|NCT05046132|143159183|OTHER||LS Mean|2.6|||||TWO_SIDED|90.0|-1.2|6.3||||||24 hr Post dose||6.3|-1.2|
71827448|NCT05046132|143159183|OTHER||LS Mean|-2.1|||||TWO_SIDED|90.0|-5.1|0.8||||||Pre-dose||0.8|-5.1|
71827449|NCT05046132|143159183|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||0.5 hr Post dose||3.0|-3.1|
71827450|NCT05046132|143159183|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||1 hr Post dose||2.9|-3.0|
71827451|NCT05046132|143159183|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.1|3.0||||||1.5 hr Post dose||3.0|-3.1|
71827452|NCT05046132|143159183|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.8|2.0||||||2 hr Post dose||2.0|-3.8|
71827453|NCT05046132|143159183|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.5|3.0||||||2.5 hr Post dose||3.0|-2.5|
71827454|NCT05046132|143159183|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-1.9|3.7||||||3 hr Post dose||3.7|-1.9|
71712682|NCT01107496|142941843|SUPERIORITY||Median Difference (Net)|0.0||||0.5308|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 1 data.||1.00|-1.00|0.5308
71766438|NCT04345367|143034386|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|-1.6|3.6|||||Sleep adequacy score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.6|-1.6|
71766439|NCT04345367|143034386|OTHER||Least square mean difference|2.9|||||TWO_SIDED|95.0|0.4|5.4|||||Sleep adequacy score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||5.4|0.4|
71766440|NCT04345367|143034386|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.9|3.4|||||Sleep adequacy score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||3.4|-1.9|
71766441|NCT04345367|143034386|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.8|1.3|||||Sleep somnolence score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||1.3|-2.8|
71827455|NCT05046132|143159183|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.2|3.7||||||4 hr Post dose||3.7|-2.2|
71827456|NCT05046132|143159183|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.8|3.1||||||5 hr Post dose||3.1|-2.8|
71827457|NCT05046132|143159183|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.9|2.0||||||6 hr Post dose||2.0|-3.9|
71712683|NCT01107496|142941843|SUPERIORITY||Median Difference (Net)|-1.0||||0.2032|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 2 data.||0.00|-2.00|0.2032
71712684|NCT01107496|142941843|SUPERIORITY||Median Difference (Net)|-1.0||||0.0677|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 3 data.||0.00|-2.00|0.0677
71712685|NCT01107496|142941843|SUPERIORITY||Median Difference (Net)|-1.0||||0.0743|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 4 data.||0.00|-2.00|0.0743
71712686|NCT01107496|142941843|SUPERIORITY||Median Difference (Net)|-1.0||||0.0437|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis pertains to Week 5 data.||0.00|-2.00|0.0437
71827458|NCT05046132|143159183|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-3.1|2.7||||||7 hr Post dose||2.7|-3.1|
71827459|NCT05046132|143159183|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-2.7|3.1||||||8 hr Post dose||3.1|-2.7|
71712687|NCT01107496|142941843|SUPERIORITY||Median Difference (Net)|-1.0||||0.1209|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||0.00|-2.00|0.1209
71712688|NCT01107496|142941844|SUPERIORITY||Median Difference (Net)|1.0||||0.6022|TWO_SIDED|95.0|-4.0|6.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 2 data.||6.00|-4.00|0.6022
71712689|NCT01107496|142941844|SUPERIORITY||Median Difference (Net)|-4.0||||0.0794|TWO_SIDED|95.0|-10.0|1.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 3 data.||1.00|-10.0|0.0794
71712690|NCT01107496|142941844|SUPERIORITY||Median Difference (Net)|-6.0||||0.0747|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 4 data.||0.00|-10.0|0.0747
71712691|NCT01107496|142941844|SUPERIORITY||Median Difference (Net)|-6.5||||0.0545|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 5 data.||0.00|-12.0|0.0545
71712692|NCT01107496|142941845|SUPERIORITY||Median Difference (Net)|7.0||||0.0349|TWO_SIDED|95.0|1.0|13.0|||Wilcoxon (Mann-Whitney)|||This analysis applies to Week 6 data.||13.00|1.00|0.0349
71766442|NCT04345367|143034386|OTHER||Least square mean difference|-2.4|||||TWO_SIDED|95.0|-4.4|-0.4|||||Sleep somnolence score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.4|-4.4|
71712693|NCT01107496|142941846|SUPERIORITY||Median Difference (Net)|-0.5||||0.4038|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 1 data||0.00|-1.00|0.4038
71712694|NCT01107496|142941846|SUPERIORITY||Median Difference (Net)|-0.5||||0.446|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 2 data||0.00|-1.00|0.4460
71766443|NCT04345367|143034386|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.3|-0.3|||||Sleep somnolence score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.3|
71766444|NCT04345367|143034386|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-3.0|0.7|||||Sleep Problems Index I score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.7|-3.0|
71766445|NCT04345367|143034386|OTHER||Least square mean difference|-2.3|||||TWO_SIDED|95.0|-4.0|-0.5|||||Sleep Problems Index I score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.5|-4.0|
71827460|NCT05046132|143159183|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-2.7|4.0||||||9 hr Post dose||4.0|-2.7|
71827461|NCT05046132|143159183|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.3|4.1||||||10 hr Post dose||4.1|-2.3|
71827462|NCT05046132|143159183|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.5|2.8||||||12 hr Post dose||2.8|-3.5|
71827463|NCT05046132|143159183|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-3.8|3.0||||||16 hr Post dose||3.0|-3.8|
71827464|NCT05046132|143159183|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.1|2.0||||||24 hr Post dose||2.0|-5.1|
71827465|NCT05046132|143159184|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|0.1|6.8||||||Pre dose||6.8|0.1|
71827466|NCT05046132|143159184|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-3.0|4.6||||||0.5 hr Post dose||4.6|-3.0|
71827467|NCT05046132|143159184|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-4.1|3.9||||||1 hr Post dose||3.9|-4.1|
71827468|NCT05046132|143159184|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-2.7|4.4||||||1.5 hr Post dose||4.4|-2.7|
71827469|NCT05046132|143159184|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.6|6.6||||||2 hr Post dose||6.6|-0.6|
71827470|NCT05046132|143159184|OTHER||LS Mean|3.5|||||TWO_SIDED|90.0|-0.3|7.4||||||2.5 hr Post dose||7.4|-0.3|
71827471|NCT05046132|143159184|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|1.2|8.1||||||3 hr Post dose||8.1|1.2|
71827472|NCT05046132|143159184|OTHER||LS Mean|5.2|||||TWO_SIDED|90.0|1.5|8.9||||||4 hr Post dose||8.9|1.5|
71712695|NCT01107496|142941846|SUPERIORITY||Median Difference (Net)|-0.5||||0.0549|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 3 data||0.00|-1.00|0.0549
71712696|NCT01107496|142941846|SUPERIORITY||Median Difference (Net)|-0.5||||0.0759|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 4 data||0.00|-1.00|0.0759
71712697|NCT01107496|142941846|SUPERIORITY||Median Difference (Net)|-0.5||||0.0342|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Analysis pertains to Week 5 data||0.00|-1.00|0.0342
71712698|NCT01107496|142941846|SUPERIORITY||Median Difference (Net)|-1.0||||0.0474|TWO_SIDED||||||Wilcoxon rank-sum test|||Analysis pertains to Week 6 data||||0.0474
71712699|NCT02496000|142941867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0117|||||||Kruskal-Wallis|ANOVA model on the ranks||This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.||||0.0117
71712700|NCT01877278|142941898|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71712701|NCT01877278|142941898|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71766446|NCT04345367|143034386|OTHER||Least square mean difference|-0.8|||||TWO_SIDED|95.0|-2.5|0.9|||||Sleep Problems Index I score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.9|-2.5|
71766447|NCT04345367|143034386|OTHER||Least square mean difference|-2.2|||||TWO_SIDED|95.0|-4.0|-0.3|||||Sleep Problems Index II score: Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.3|-4.0|
71766448|NCT04345367|143034386|OTHER||Least square mean difference|-2.9|||||TWO_SIDED|95.0|-4.8|-1.1|||||Sleep Problems Index II score: Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-1.1|-4.8|
71766449|NCT04345367|143034386|OTHER||Least square mean difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4|||||Sleep Problems Index II score: Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.4|-3.2|
71766450|NCT04345367|143034387|OTHER||Least square mean difference|-1.1|||||TWO_SIDED|95.0|-1.5|-0.8|||||Week 2. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.8|-1.5|
71766451|NCT04345367|143034387|OTHER||Least square mean difference|-0.4|||||TWO_SIDED|95.0|-0.8|-0.1|||||Week 12. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||-0.1|-0.8|
71766452|NCT04345367|143034387|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Week 16. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.6|
71766453|NCT04345367|143034387|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.0|||||Week 20. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.0|-0.6|
71766454|NCT04345367|143034387|OTHER||Least square mean difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Week 26. Analysis was performed using MMRM with fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, baseline value and an unstructured covariance matrix.|||0.1|-0.5|
71766455|NCT04345367|143034388|OTHER||Least square mean difference|18.1|||||TWO_SIDED|95.0|10.5|25.7||||||Analysis was performed using analysis of covariance (ANCOVA) model including treatment as a main effect and baseline disease severity as covariates.||25.7|10.5|
71766456|NCT04345367|143034389|OTHER||Estimate of difference|13.7|||||TWO_SIDED|95.0|7.3|20.1|||||Week 2. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||20.1|7.3|
71766457|NCT04345367|143034389|OTHER||Estimate of difference|3.9|||||TWO_SIDED|95.0|-1.6|9.4|||||Week 12. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||9.4|-1.6|
71766458|NCT04345367|143034389|OTHER||Estimate of difference|-1.6|||||TWO_SIDED|95.0|-7.1|4.0|||||Week 16. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||4.0|-7.1|
71766459|NCT04345367|143034389|OTHER||Estimate of difference|-2.0|||||TWO_SIDED|95.0|-7.6|3.6|||||Week 20. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||3.6|-7.6|
71766460|NCT04345367|143034389|OTHER||Estimate of difference|-4.2|||||TWO_SIDED|95.0|-10.3|1.9|||||Week 26. The estimate and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions.|||1.9|-10.3|
71766461|NCT04525885|143034407|SUPERIORITY|Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|Estimated Relative Reduction (%)|8.7||||0.713|TWO_SIDED|95.0|-30.51|70.03|||ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||70.03|-30.51|0.713
71827473|NCT05046132|143159184|OTHER||LS Mean|2.0|||||TWO_SIDED|90.0|-1.7|5.8||||||5 hr Post dose||5.8|-1.7|
71827474|NCT05046132|143159184|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-1.6|5.1||||||6 hr Post dose||5.1|-1.6|
71712702|NCT01877278|142941899|SUPERIORITY_OR_OTHER||||||=|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||=0.0001
71712703|NCT01877278|142941899|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71712704|NCT05318287|142941900|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.083|TWO_SIDED||||||t-test, 2 sided|||||||.083
71712705|NCT05318287|142941901|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||t-test, 2 sided|||||||.010
71656165|NCT01030341|142830581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.005||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.||||0.005
71712706|NCT05318287|142941902|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.16|TWO_SIDED||||||t-test, 2 sided|||||||.160
71712707|NCT05318287|142941903|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.167|TWO_SIDED||||||t-test, 2 sided|||||||.167
71712708|NCT05318287|142941904|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.012|TWO_SIDED||||||t-test, 2 sided|||||||.012
71712709|NCT05318287|142941905|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.347|TWO_SIDED||||||t-test, 2 sided|||||||.347
71712710|NCT05318287|142941906|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.007|TWO_SIDED||||||t-test, 2 sided|||||||.007
71827475|NCT05046132|143159184|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.1|5.7||||||7 hr Post dose||5.7|-1.1|
71827476|NCT05046132|143159184|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.4|6.2||||||8 hr Post dose||6.2|-1.4|
71827477|NCT05046132|143159184|OTHER||LS Mean|4.4|||||TWO_SIDED|90.0|0.9|7.8||||||9 hr Post dose||7.8|0.9|
71656166|NCT01030341|142830581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9||||||0.04||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>180 mg/dL) during the screening phase and treatment phase respectively.||||0.04
71656167|NCT01030341|142830581|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (\>300 mg/dL) during the screening phase and treatment phase respectively.||||<0.0001
71656168|NCT01030341|142830582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.||||<0.0001
71656169|NCT01030341|142830582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.||||<0.0001
71656170|NCT01030341|142830582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.||||<0.0001
71656171|NCT01030341|142830582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.||||<0.0001
71656172|NCT01030341|142830582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.||||<0.0001
71656173|NCT01030341|142830582|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.||||<0.0001
71656174|NCT02307266|142830588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
71656175|NCT02307266|142830588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|||||||Cochran-Mantel-Haenszel|||||||0.0206
71656176|NCT02766374|142830604|SUPERIORITY||||||>|0.1|||||||GEE regression|||||||>0.1
71656177|NCT05855616|142830633|OTHER||Odds Ratio (OR)|0.533||||1|TWO_SIDED|95.0|0.048|5.892|||t-test, 1 sided|||||5.892|0.048|1.00
71656178|NCT05855616|142830634|OTHER||Odds Ratio (OR)|0.176||||0.013|TWO_SIDED|95.0|0.039|0.79|||t-test, 1 sided|||||0.790|0.039|0.013
71656179|NCT05855616|142830636|OTHER|||||||0.137|||||||Chi-squared, Corrected|||||||0.137
71656180|NCT05855616|142830637|OTHER|||||||0.764|||||||Chi-squared, Corrected|||||||0.764
71656181|NCT05855616|142830638|OTHER|||||||0.055|||||||Chi-squared, Corrected|||||||0.055
71656182|NCT00974974|142830663|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
71656183|NCT00974974|142830664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<.0001
71656184|NCT04492020|142830738|SUPERIORITY||Odds Ratio (OR)|2.09|||<|0.0001|TWO_SIDED|95.0|1.63|2.69|||generalized linear mixed model (GLMM)|||||2.69|1.63|<.0001
71712711|NCT05318287|142941907|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
71712712|NCT05318287|142941908|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.403|TWO_SIDED||||||t-test, 2 sided|||||||.403
71712713|NCT05318287|142941909|EQUIVALENCE|Whether change in linear slope from pretest through the 8-week follow-up is equivalent to zero (null hypothesis).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.194|TWO_SIDED||||||t-test, 2 sided|||||||.194
71712714|NCT00391716|142941935|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.|Mantel Haenszel|Extended Mantel-Haenszel Chi-square test for linear-by-linear association.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.04
71827478|NCT05046132|143159184|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|0.3|7.4||||||10 hr Post dose||7.4|0.3|
71827479|NCT05046132|143159184|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-4.2|2.7||||||12 hr Post dose||2.7|-4.2|
71827480|NCT05046132|143159184|OTHER||LS Mean|3.6|||||TWO_SIDED|90.0|0.1|7.0||||||16 hr Post dose||7.0|0.1|
71656185|NCT04492020|142830739|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.0001|TWO_SIDED|95.0|1.63|2.78|||generalized linear mixed model (GLMM)|||||2.78|1.63|<.0001
71656186|NCT04492020|142830740|SUPERIORITY||Geometric Mean Odds Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.4|1.96|||generalized estimating equation (GEE)|||||1.96|1.40|<.0001
71656187|NCT04492020|142830741|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.39|2.66|||generalized linear mixed model (GLMM)|||||2.66|1.39|<.0001
71656188|NCT00063635|142830742|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.26
71656189|NCT00063635|142830742|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel|||||||0.83
71656190|NCT00063635|142830743|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||ANCOVA|||||||0.32
71656191|NCT00063635|142830743|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|||||||0.29
71656192|NCT00063635|142830744|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
71656193|NCT00063635|142830744|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
71656194|NCT00063635|142830745|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||||||0.71
71656195|NCT00063635|142830745|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Chi-squared|||||||0.72
71656196|NCT00063635|142830746|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Chi-squared|||||||0.18
71766462|NCT04525885|143034410|SUPERIORITY||Estimated Relative Reduction (%)|11.58||||0.628|TWO_SIDED|95.0|-28.68|74.57||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA||Estimated relative reduction (ERR) relative to placebo was calculated by 100 (e\*\*DIFF -1), where e\*\*DIFF=exponent of difference; and DIFF= treatment difference in change from baseline at Week 24 based on log transformed data.|||74.57|-28.68|0.628
71766463|NCT04525885|143034411|SUPERIORITY||Odds Ratio (OR)|0.96||||0.917|TWO_SIDED|95.0|0.43|2.13||Comparison based on logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline LCQ total score, and the interaction of baseline LCQ total score by visit as covariates.|Regression, Logistic|||||2.13|0.43|0.917
71766464|NCT04525885|143034412|SUPERIORITY||Odds Ratio (OR)|0.85||||0.687|TWO_SIDED|95.0|0.38|1.88||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline 24-hour coughs per hour and the interaction of baseline 24-hour coughs per hour by visit as covariates.|Regression, Logistic|||||1.88|0.38|0.687
71656197|NCT00063635|142830746|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Chi-squared|||||||0.25
71656198|NCT00063635|142830747|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Chi-squared|||||||0.89
71656199|NCT00063635|142830747|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
71656200|NCT00063635|142830748|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71656201|NCT00063635|142830748|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71656202|NCT00063635|142830749|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||ANCOVA|||||||0.77
71656203|NCT00063635|142830749|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANCOVA|||||||0.25
71656204|NCT00063635|142830750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71656205|NCT00063635|142830750|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANCOVA|||||||0.44
71656206|NCT00063635|142830751|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
71656207|NCT00063635|142830751|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANCOVA|||||||0.63
71656208|NCT00063635|142830752|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANCOVA|||||||0.15
71656209|NCT00063635|142830752|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||ANCOVA|||||||0.96
71656210|NCT02792959|142830795|NON_INFERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
71656211|NCT02792959|142830796|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
71656212|NCT02792959|142830797|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.0||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
71656213|NCT02792959|142830798|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.091||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
71656214|NCT02792959|142830799|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
71656215|NCT02792959|142830800|SUPERIORITY|alpha=5%|Mean Difference (Net)|3.361||||0.067|TWO_SIDED||||||Kruskal-Wallis|||||||0.067
71656216|NCT02792959|142830801|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.0||||0.296|TWO_SIDED||||||Kruskal-Wallis|||||||0.296
71656217|NCT02792959|142830802|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
71656218|NCT02792959|142830803|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.068||||0.794|TWO_SIDED||||||Kruskal-Wallis|||||||0.794
71656219|NCT02792959|142830804|SUPERIORITY|alpha=5%|Mean Difference (Net)|4.39||||0.036|TWO_SIDED||||||Kruskal-Wallis|||||||0.036
71656220|NCT02792959|142830805|SUPERIORITY|alpha=5%|Mean Difference (Net)|0.273||||0.602|TWO_SIDED||||||Kruskal-Wallis|||||||0.602
71656221|NCT02792959|142830806|SUPERIORITY|alpha=5%|Mean Difference (Net)|1.705||||0.192|TWO_SIDED||||||Kruskal-Wallis|||||||0.192
71656222|NCT03914950|142830816|OTHER|"The calculation of power and sample size is based on a formula that selects the sample size so that the lower limit of the 95% confidence interval by the expected specificity of the new method most probably exceeds the specificity value of the current method.~Receiver operating characteristics (ROC) analysis of the values of SUVmax of the early and delayed images with and without TOF of all pancreatic lesions was done in correlation with the histopathological findings."||||||0.78|||||||DeLong-test|The threshold for statistical significance was p=0.05.||It was calculated that 118 participants would have at least 90% power to demonstrate an improvement in specificity of 25% (to 70%) with the new method assuming a specificity of the current method of 45% at a prevalence of malignant lesions of 70% (corresponding to 30% benign lesions). Assumptions included a discontinuation rate of 25%.||||0.78
71656223|NCT03914950|142830816|OTHER|||||||0.95|||||||DeLong-test|The threshold for statistical significance was p=0.05.||||||0.95
71656224|NCT04168190|142830829|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|-10.0|||||TWO_SIDED|95.0|-29.3|9.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site erythema||9.0|-29.3|
71712715|NCT00391716|142941935|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED|||||linear dose effects for rates of abstinence were assessed using the extended Mantel-Haenszel chi-square test for linear association.|Mantel Haenszel|The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.||||<0.02
71712716|NCT00391716|142941936|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
71712717|NCT00391716|142941937|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Cumulative means over 12 weeks|ANOVA|||||||<0.001
71712718|NCT00391716|142941938|SUPERIORITY_OR_OTHER||||||<|0.003||||||Cumulative means over 12 weeks|ANOVA|||||||<0.003
71712719|NCT00934180|142941968|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.0||||||90.0|95.1|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||111|95.1|
71712720|NCT00934180|142941969|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.3|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|95.3|
71712721|NCT00934180|142941970|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.2|108.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||108|95.2|
71712722|NCT00835172|142941971|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|92.1|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||112|92.1|
71712723|NCT00835172|142941972|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|96.8|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105|96.8|
71712724|NCT00835172|142941973|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.0||||||90.0|99.3|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|99.3|
71712725|NCT03274466|142941995|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||0.59|0.08|0.0013
71712726|NCT03274466|142941996|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.33||||0.168|TWO_SIDED|95.0|0.07|1.7||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||1.70|0.07|0.1680
71712727|NCT03274466|142941997|SUPERIORITY|Modified Intent-To-Treat|Odds Ratio (OR)|0.34||||0.3386|TWO_SIDED|95.0|0.04|3.39||Threshold for Statistical Significance: alpha = 0.048|Cochran-Mantel-Haenszel|||||3.39|0.04|0.3386
71712728|NCT03274466|142941998|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0013|TWO_SIDED|95.0|0.08|0.59||Threshold for statistical significance: alpha = 0.048|Cochran-Mantel-Haenszel|||Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.||0.59|0.08|0.0013
71712729|NCT02989857|142941999|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.54||P-value was calculated from the one-sided stratified log-rank test.|Log Rank||Hazard ratio was calculated from stratified Cox regression model with placebo as the denominator, with two-sided 95% confidence interval.|||0.54|0.25|<0.0001
71712730|NCT02989857|142942006|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.093|TWO_SIDED|95.0|0.56|1.12||P-value was calculated from the one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the comparator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||1.12|0.56|0.093
71712731|NCT02989857|142942007|SUPERIORITY|||||||0.466||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.466
71712732|NCT02989857|142942008|SUPERIORITY|||||||0.299||||||P-value was calculated from 1-sided Fisher exact test.|Fisher Exact|||||||0.299
71712733|NCT02989857|142942013|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68||P-value was calculated from one-sided stratified log-rank test. Stratification factor was the number of prior line of therapies at randomization.|Log Rank||Hazard ratio was calculated from the stratified Cox regression model with placebo as the denominator, with two-sided 95% CI. Stratification factor was the number of prior line of therapies at randomization.|||0.68|0.33|<0.0001
71712734|NCT02989857|142942014|OTHER||Least-squares mean difference|11.0|||||TWO_SIDED|95.0|4.23|17.73||||||Cycle 2 Day 1: Physical Functioning||17.73|4.23|
71712735|NCT02989857|142942014|OTHER||Least-squares mean difference|-10.4|||||TWO_SIDED|95.0|-20.18|-0.52||||||Cycle 2 Day 1: Pain||-0.52|-20.18|
71712736|NCT02989857|142942014|OTHER||Least-squares mean difference|3.6|||||TWO_SIDED|95.0|-6.65|13.91||||||Cycle 2 Day 1: Appetite Loss||13.91|-6.65|
71712737|NCT02989857|142942014|OTHER||Least-squares mean difference|12.3|||||TWO_SIDED|95.0|3.85|20.78||||||Cycle 3 Day 1: Physical Functioning||20.78|3.85|
71712738|NCT02989857|142942014|OTHER||Least-squares mean difference|4.1|||||TWO_SIDED|95.0|-8.74|17.04||||||Cycle 3 Day 1: Pain||17.04|-8.74|
71712739|NCT02989857|142942014|OTHER||Least-squares mean difference|-3.7|||||TWO_SIDED|95.0|-17.46|10.11||||||Cycle 3 Day 1: Appetite Loss||10.11|-17.46|
71712740|NCT02989857|142942015|OTHER||Least-squares mean difference|-5.1|||||TWO_SIDED|95.0|-12.93|2.8||||||Cycle 2 Day 1: Pain||2.80|-12.93|
71712741|NCT02989857|142942015|OTHER||Least-squares mean difference|0.7|||||TWO_SIDED|95.0|-6.56|7.88||||||Cycle 2 Day 1: Appetite Loss||7.88|-6.56|
71712742|NCT02989857|142942015|OTHER||Least-squares mean difference|4.4|||||TWO_SIDED|95.0|-5.82|14.55||||||Cycle 3 Day 1: Pain||14.55|-5.82|
71766465|NCT04525885|143034413|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.49|2.49||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score and the interaction of baseline mean weekly CSD total score by visit as covariates.||2.49|0.49|
71827481|NCT05046132|143159184|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-5.7|2.8||||||24 hr Post dose||2.8|-5.7|
71712743|NCT02989857|142942015|OTHER||Least-squares mean difference|-6.1|||||TWO_SIDED|95.0|-15.34|3.12||||||Cycle 3 Day 1: Appetite Loss||3.12|-15.34|
71656225|NCT04168190|142830829|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-18.1|24.6|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site erythema||24.6|-18.1|
71656226|NCT04168190|142830829|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-7.7|39.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site pain||39.3|-7.7|
71656227|NCT04168190|142830829|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|20.0|||||TWO_SIDED|95.0|-4.1|42.1|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site pain||42.1|-4.1|
71656228|NCT04168190|142830829|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|6.7|||||TWO_SIDED|95.0|-13.2|26.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Injection site swelling||26.5|-13.2|
71656229|NCT04168190|142830829|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-16.0|22.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Injection site swelling||22.8|-16.0|
71656230|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
71656231|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-11.4|31.0|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Fatigue||31.0|-11.4|
71656232|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|10.0|||||TWO_SIDED|95.0|-7.4|28.3|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Arthralgia||28.3|-7.4|
71656233|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-13.1|20.2|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Arthralgia||20.2|-13.1|
71656234|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-7.5|33.8|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Myalgia||33.8|-7.5|
71656235|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|16.7|||||TWO_SIDED|95.0|-4.6|37.3|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Myalgia||37.3|-4.6|
71656236|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|13.3|||||TWO_SIDED|95.0|-8.5|34.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|Headache||34.5|-8.5|
71656237|NCT04168190|142830830|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.3|||||TWO_SIDED|95.0|-17.2|23.8|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|Headache||23.8|-17.2|
71656238|NCT04168190|142830831|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 0.5 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
71656239|NCT04168190|142830831|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-11.5|11.5|||||Phase 1: V116 1.0 mL minus Phase 1: Pneumovax™23|||11.5|-11.5|
71656240|NCT04168190|142830832|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|2.0|||||TWO_SIDED|95.0|-2.8|6.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site erythema||6.8|-2.8|
71656241|NCT04168190|142830832|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|8.7|||||TWO_SIDED|95.0|0.1|17.1|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site pain||17.1|0.1|
71656242|NCT04168190|142830832|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.1|||||TWO_SIDED|95.0|-2.0|8.4|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Injection site swelling||8.4|-2.0|
71656243|NCT04168190|142830833|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|7.1|||||TWO_SIDED|95.0|0.8|13.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Fatigue||13.5|0.8|
71656244|NCT04168190|142830833|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Arthralgia||3.8|-3.8|
71656245|NCT04168190|142830833|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.8|7.0|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Myalgia||7.0|-3.8|
71656246|NCT04168190|142830833|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|9.9|||||Phase 2: V116 minus Phase 2: Pneumovax™23|Headache||9.9|-2.7|
71656247|NCT04168190|142830834|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.5|1.5|||||Phase 2: V116 minus Phase 2: Pneumovax™23|||1.5|-1.5|
71712744|NCT01168596|142942041|SUPERIORITY_OR_OTHER||Slope|1.3|STANDARD_ERROR_OF_MEAN|5.26||0.81|TWO_SIDED|95.0|-9.13|11.73|||Regression, Linear|||||11.73|-9.13|0.81
71712745|NCT01168596|142942042|SUPERIORITY_OR_OTHER||Slope|4.38|STANDARD_ERROR_OF_MEAN|3.6||0.23|TWO_SIDED|95.0|-2.75|11.51|||Regression, Linear|||||11.51|-2.75|0.23
71656248|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.82|1.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.22|0.82|<0.001
71712746|NCT01168596|142942043|SUPERIORITY_OR_OTHER||Slope|1.61|STANDARD_ERROR_OF_MEAN|5.03||0.75|TWO_SIDED|95.0|-8.37|11.59|||Regression, Linear|||||11.59|-8.37|0.75
71712747|NCT01168596|142942044|SUPERIORITY_OR_OTHER||Slope|1.88|STANDARD_ERROR_OF_MEAN|3.06||0.54|TWO_SIDED|95.0|-4.18|7.94|||Regression, Linear|||||7.94|-4.18|0.54
71827482|NCT05046132|143159184|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-1.0|5.6||||||Pre dose||5.6|-1.0|
71827483|NCT05046132|143159184|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-5.4|2.2||||||0.5 hr Post dose||2.2|-5.4|
71827484|NCT05046132|143159184|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.8|4.3||||||1 hr Post dose||4.3|-3.8|
71827485|NCT05046132|143159184|OTHER||LS Mean|4.0|||||TWO_SIDED|90.0|0.4|7.6||||||1.5 hr Post dose||7.6|0.4|
71712748|NCT01168596|142942045|SUPERIORITY_OR_OTHER||Slope|-5.17|STANDARD_ERROR_OF_MEAN|6.36||0.42|TWO_SIDED|95.0|-17.76|7.43|||Regression, Linear|||||7.43|-17.76|0.42
71712749|NCT01168596|142942046|SUPERIORITY_OR_OTHER||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.47||0.44|TWO_SIDED|95.0|-0.56|1.29|||Regression, Linear|||||1.29|-0.56|0.44
71827486|NCT05046132|143159184|OTHER||LS Mean|6.3|||||TWO_SIDED|90.0|2.7|10.0||||||2 hr Post dose||10.0|2.7|
71712750|NCT01168596|142942047|SUPERIORITY_OR_OTHER||Slope|2.27|STANDARD_ERROR_OF_MEAN|10.02||0.82|TWO_SIDED|95.0|-17.59|22.13|||Regression, Linear|||||22.13|-17.59|0.82
71712751|NCT01168596|142942048|SUPERIORITY_OR_OTHER||Slope|-4.73|STANDARD_ERROR_OF_MEAN|7.36||0.52|TWO_SIDED|95.0|-19.31|9.85|||Regression, Linear|||||9.85|-19.31|0.52
71827487|NCT05046132|143159184|OTHER||LS Mean|6.4|||||TWO_SIDED|90.0|2.6|10.2||||||2.5 hr Post dose||10.2|2.6|
71827488|NCT05046132|143159184|OTHER||LS Mean|8.5|||||TWO_SIDED|90.0|5.0|12.0||||||3 hr Post dose||12.0|5.0|
71712752|NCT01168596|142942049|SUPERIORITY_OR_OTHER||Slope|0.11|STANDARD_ERROR_OF_MEAN|1.14||0.93|TWO_SIDED|95.0|-2.15|2.36|||Regression, Linear|||||2.36|-2.15|0.93
71712753|NCT01168596|142942050|SUPERIORITY_OR_OTHER||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.47||0.82|TWO_SIDED|95.0|-1.05|0.83|||Regression, Linear|||||0.83|-1.05|0.82
71712754|NCT01168596|142942051|SUPERIORITY_OR_OTHER||Slope|-4.53|STANDARD_ERROR_OF_MEAN|7.68||0.56|TWO_SIDED|95.0|-19.74|10.69|||Regression, Linear|||||10.69|-19.74|0.56
71827489|NCT05046132|143159184|OTHER||LS Mean|10.1|||||TWO_SIDED|90.0|6.4|13.8||||||4 hr Post dose||13.8|6.4|
71827490|NCT05046132|143159184|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.1|11.6||||||5 hr Post dose||11.6|4.1|
71827491|NCT05046132|143159184|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|4.4|11.2||||||6 hr Post dose||11.2|4.4|
71827492|NCT05046132|143159184|OTHER||LS Mean|6.8|||||TWO_SIDED|90.0|3.4|10.2||||||7 hr Post dose||10.2|3.4|
71827493|NCT05046132|143159184|OTHER||LS Mean|4.5|||||TWO_SIDED|90.0|0.6|8.3||||||8 hr Post dose||8.3|0.6|
71827494|NCT05046132|143159184|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.1|10.0||||||9 hr Post dose||10.0|3.1|
71827495|NCT05046132|143159184|OTHER||LS Mean|6.6|||||TWO_SIDED|90.0|3.0|10.1||||||10 hr Post dose||10.1|3.0|
71712755|NCT01168596|142942052|SUPERIORITY_OR_OTHER||Slope|-2.21|STANDARD_ERROR_OF_MEAN|2.93||0.45|TWO_SIDED|95.0|-8.02|3.59|||Regression, Linear|||||3.59|-8.02|0.45
71712756|NCT01168596|142942053|SUPERIORITY_OR_OTHER||Slope|2.76|STANDARD_ERROR_OF_MEAN|4.94||0.58|TWO_SIDED|95.0|-7.02|12.55|||Regression, Linear|||||12.55|-7.02|0.58
71712757|NCT01168596|142942054|SUPERIORITY_OR_OTHER||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.54||0.95|TWO_SIDED|95.0|-1.04|1.11|||Regression, Linear|||||1.11|-1.04|0.95
71712758|NCT01168596|142942055|SUPERIORITY_OR_OTHER||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.54||0.48|TWO_SIDED|95.0|-1.45|0.69|||Regression, Linear|||||0.69|-1.45|0.48
71712759|NCT01168596|142942056|SUPERIORITY_OR_OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.84|TWO_SIDED|95.0|-0.71|0.58|||Regression, Linear|||||0.58|-0.71|0.84
71712760|NCT01168596|142942057|SUPERIORITY_OR_OTHER||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.44|TWO_SIDED|95.0|-0.77|1.76|||Regression, Linear|||||1.76|-0.77|0.44
71712761|NCT01168596|142942058|SUPERIORITY_OR_OTHER||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.88||0.71|TWO_SIDED|95.0|-2.06|1.41|||Regression, Linear|||||1.41|-2.06|0.71
71712762|NCT01168596|142942059|SUPERIORITY_OR_OTHER||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.64||0.31|TWO_SIDED|95.0|-0.62|1.9|||Regression, Linear|||||1.90|-0.62|0.31
71712763|NCT01168596|142942060|SUPERIORITY_OR_OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.82||0.94|TWO_SIDED|95.0|-1.68|1.56|||Regression, Linear|||||1.56|-1.68|0.94
71712764|NCT00123630|142942085|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71712765|NCT01098747|142942105|SUPERIORITY_OR_OTHER||Least-square (LS) mean difference|24.21|||<|0.001|TWO_SIDED|95.0|19.32|29.09||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||29.09|19.32|<0.001
71766466|NCT04525885|143034414|OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.8|4.64||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly CSD total score, and the interaction of baseline mean weekly CSD total score by visit as covariates||4.64|0.80|
71827496|NCT05046132|143159184|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.8|8.8||||||12 hr Post dose||8.8|1.8|
71827497|NCT05046132|143159184|OTHER||LS Mean|7.2|||||TWO_SIDED|90.0|3.7|10.6||||||16 hr Post dose||10.6|3.7|
71827498|NCT05046132|143159184|OTHER||LS Mean|3.3|||||TWO_SIDED|90.0|-1.0|7.5||||||24 hr Post dose||7.5|-1.0|
71827499|NCT05046132|143159185|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.7|11.8||||||Pre dose||11.8|3.7|
71827500|NCT05046132|143159185|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|3.3|9.8||||||0.5 hr Post dose||9.8|3.3|
71827501|NCT05046132|143159185|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1 hr Post dose||8.6|0.6|
71827502|NCT05046132|143159185|OTHER||LS Mean|4.6|||||TWO_SIDED|90.0|0.6|8.6||||||1.5 hr Post dose||8.6|0.6|
71827503|NCT05046132|143159185|OTHER||LS Mean|3.8|||||TWO_SIDED|90.0|-0.4|8.0||||||2 hr Post dose||8.0|-0.4|
71827504|NCT05046132|143159185|OTHER||LS Mean|6.1|||||TWO_SIDED|90.0|1.8|10.4||||||2.5 hr Post dose||10.4|1.8|
71827505|NCT05046132|143159185|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.7|9.8||||||3 hr Post dose||9.8|1.7|
71827506|NCT05046132|143159185|OTHER||LS Mean|6.2|||||TWO_SIDED|90.0|2.5|9.8||||||4 hr Post dose||9.8|2.5|
71827507|NCT05046132|143159185|OTHER||LS Mean|5.7|||||TWO_SIDED|90.0|1.6|9.8||||||5 hr Post dose||9.8|1.6|
71827508|NCT05046132|143159185|OTHER||LS Mean|4.8|||||TWO_SIDED|90.0|1.1|8.4||||||6 hr Post dose||8.4|1.1|
71827509|NCT05046132|143159185|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|-0.9|7.0||||||7 hr Post dose||7.0|-0.9|
71827510|NCT05046132|143159185|OTHER||LS Mean|5.0|||||TWO_SIDED|90.0|1.3|8.8||||||8 hr Post dose||8.8|1.3|
71712766|NCT01098747|142942106|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.8|||<|0.001|TWO_SIDED|95.0|6.78|24.15||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||24.15|6.78|<0.001
71712767|NCT01098747|142942106|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.001|TWO_SIDED|95.0|1.22|2.06||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.||2.06|1.22|<0.001
71712768|NCT01098747|142942107|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|12.36|||<|0.001|TWO_SIDED|95.0|6.51|23.46||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||23.46|6.51|<0.001
71712769|NCT01098747|142942107|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8|||<|0.001|TWO_SIDED|95.0|1.38|2.34||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.34|1.38|<0.001
71712770|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|0.35||||0.007|TWO_SIDED|95.0|0.1|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.10|0.007
71712771|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.01|TWO_SIDED|95.0|0.06|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.42|0.06|0.010
71712772|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|1.47|||<|0.001|TWO_SIDED|95.0|1.1|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.||1.84|1.10|<0.001
71712773|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.27|0.8||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.80|0.27|<0.001
71712774|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|2.22|||<|0.001|TWO_SIDED|95.0|1.84|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.84|<0.001
71712775|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.006|TWO_SIDED|95.0|0.12|0.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.66|0.12|0.006
71766467|NCT04525885|143034415|OTHER|Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, baseline mean weekly VAS score, and the interaction of baseline mean weekly VAS score by visit as covariates.|Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.45|2.72||||||||2.72|0.45|
71766468|NCT01755026|143034437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|191.0|STANDARD_ERROR_OF_MEAN|166.01|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
71766469|NCT01227629|143034466|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to last available value||||0.0357
71766470|NCT01227629|143034467|SUPERIORITY_OR_OTHER|||||||0.26711||95.0|||||Kruskal-Wallis|||Group comparison of differences from baseline to week 12||||0.26711
71766471|NCT00362180|143034477|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 26.||||0.7244
71766472|NCT00362180|143034477|SUPERIORITY_OR_OTHER|||||||0.0513|TWO_SIDED||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 99.||||0.0513
71766473|NCT03930264|143034485|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for tablet and suspension were required to be within the 80 to 125% range.|Odds Ratio (OR)|1.12||||0.3008|TWO_SIDED|90.0|0.93|1.35|||ANOVA|||||1.35|0.93|0.3008
71766474|NCT03930264|143034486|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-τ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.06||||0.1061|TWO_SIDED|90.0|1.0|1.13|||ANOVA|||||1.13|1.00|0.1061
71766475|NCT03930264|143034487|EQUIVALENCE|For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-∞ for tablet and suspension were required to be within the 80 to 125% range.|Ratio|1.02||||0.5696|TWO_SIDED|90.0|0.96|1.09|||ANOVA|||||1.09|0.96|0.5696
71766476|NCT02434471|143034488|OTHER||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71766477|NCT02434471|143034489|OTHER||Mean Difference (Final Values)|0.1||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71766478|NCT01347580|143034503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8214|TWO_SIDED|95.0|0.799|1.327||pvalue at 0.025 , adjusted for multiple comparisons|Regression, Logistic|||||1.327|0.799|0.8214
71712776|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.77||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.77|2.00|<0.001
71712777|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.022|TWO_SIDED|95.0|0.05|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.60|0.05|0.022
71712778|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|2.0|2.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.79|2.00|<0.001
71712779|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|0.13||||0.369|TWO_SIDED|95.0|-0.15|0.41||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.41|-0.15|0.369
71712780|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|2.19|||<|0.001|TWO_SIDED|95.0|1.78|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.60|1.78|<0.001
71712781|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.42|TWO_SIDED|95.0|-0.42|0.17||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.17|-0.42|0.420
71712782|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|2.02|||<|0.001|TWO_SIDED|95.0|1.58|2.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.45|1.58|<0.001
71712783|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.151|TWO_SIDED|95.0|-0.54|0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.08|-0.54|0.151
71712784|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.33|1.43|<0.001
71712785|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.16|TWO_SIDED|95.0|-0.56|0.09||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.09|-0.56|0.160
71712786|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.16|2.1||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.10|1.16|<0.001
71712787|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.055|TWO_SIDED|95.0|-0.67|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||0.01|-0.67|0.055
71766479|NCT01347580|143034504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.074||||0.6322|TWO_SIDED|95.0|0.801|1.441||P value at 0.025 adjusted for multiple comparisons|Regression, Logistic|||||1.441|0.801|0.6322
71766480|NCT01347580|143034505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.027||||0.9056|TWO_SIDED|95.0|0.661|1.595|||Regression, Logistic|||||1.595|0.661|0.9056
71766481|NCT01347580|143034506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.4168|TWO_SIDED|95.0|0.76|1.942|||Regression, Logistic|||||1.942|0.760|0.4168
71712788|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|0.91|1.88||p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.88|0.91|<0.001
71766482|NCT01347580|143034507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.189||||0.0307|TWO_SIDED|95.0|0.042|0.856|||Regression, Logistic|||||0.856|0.042|0.0307
71766483|NCT01347580|143034508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.132||||0.344|TWO_SIDED|95.0|0.876|1.462|||Regression, Logistic|||||1.462|0.876|0.344
71766484|NCT01347580|143034509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.0547|TWO_SIDED|95.0|0.996|1.506|||Regression, Logistic|||||1.506|0.996|0.0547
71766485|NCT01347580|143034510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.803||||0.166|TWO_SIDED|95.0|0.588|1.096|||Regression, Logistic|||||1.096|0.588|0.1660
71766486|NCT02204124|143034528|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71766487|NCT02204124|143034529|SUPERIORITY|||||||0.513|||||||Chi-squared|||||||0.513
71766488|NCT02204124|143034532|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71766489|NCT02204124|143034533|SUPERIORITY|||||||0.132|||||||Chi-squared|||||||0.132
71712789|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|-0.37||||0.04|TWO_SIDED|95.0|-0.71|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.02|-0.71|0.040
71827511|NCT05046132|143159185|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.5|10.6||||||9 hr Post dose||10.6|2.5|
71712790|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.71|1.69||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.69|0.71|<0.001
71712791|NCT01098747|142942108|SUPERIORITY_OR_OTHER||LS mean difference|-0.44||||0.015|TWO_SIDED|95.0|-0.79|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||-0.08|-0.79|0.015
71712792|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.3|||<|0.001|TWO_SIDED|95.0|0.13|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.13|<0.001
71712793|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.34|0.11|<0.001
71712794|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.94|||<|0.001|TWO_SIDED|95.0|0.7|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.70|<0.001
71712795|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.38|||<|0.001|TWO_SIDED|95.0|0.2|0.55||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.55|0.20|<0.001
71712796|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.18|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.75|1.18|<0.001
71712797|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.017|TWO_SIDED|95.0|0.04|0.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.45|0.04|0.017
71712798|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.39|1.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.96|1.39|<0.001
71712799|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.015|TWO_SIDED|95.0|0.05|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.05|0.015
71827512|NCT05046132|143159185|OTHER||LS Mean|8.6|||||TWO_SIDED|90.0|4.8|12.3||||||10 hr Post dose||12.3|4.8|
71827513|NCT05046132|143159185|OTHER||LS Mean|7.9|||||TWO_SIDED|90.0|4.4|11.4||||||12 hr Post dose||11.4|4.4|
71712800|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.41|1.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.98|1.41|<0.001
71712801|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.362|TWO_SIDED|95.0|-0.11|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.11|0.362
71712802|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.56|||<|0.001|TWO_SIDED|95.0|1.27|1.86||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.86|1.27|<0.001
71712803|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.472|TWO_SIDED|95.0|-0.29|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.29|0.472
71827514|NCT05046132|143159185|OTHER||LS Mean|4.9|||||TWO_SIDED|90.0|0.9|8.9||||||16 hr Post dose||8.9|0.9|
71827515|NCT05046132|143159185|OTHER||LS Mean|7.8|||||TWO_SIDED|90.0|3.6|12.0||||||24 hr Post dose||12.0|3.6|
71827516|NCT05046132|143159185|OTHER||LS Mean|2.1|||||TWO_SIDED|90.0|-1.8|6.0||||||Pre dose||6.0|-1.8|
71712804|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.39|||<|0.001|TWO_SIDED|95.0|1.07|1.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.70|1.07|<0.001
71766490|NCT02204124|143034534|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #1 is for readmission||||0.975
71827517|NCT05046132|143159185|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|0.0|6.2||||||0.5 hr Post dose||6.2|-0.0|
71656249|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|0.95|1.56|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.56|0.95|<0.001
71656250|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.9|1.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.41|0.90|<0.001
71656251|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.58|||<|0.001|TWO_SIDED|95.0|1.16|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.16|<0.001
71656252|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.71|1.24|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.24|0.71|<0.001
71656253|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.8|1.21|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.21|0.80|<0.001
71656254|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.87|1.47|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.47|0.87|<0.001
71656255|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.19|||<|0.001|TWO_SIDED|95.0|0.93|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.93|<0.001
71656256|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.78|2.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.90|1.78|<0.001
71656257|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|2.57|||<|0.001|TWO_SIDED|95.0|1.86|3.55|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.55|1.86|<0.001
71656258|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.64|||<|0.001|TWO_SIDED|95.0|1.24|2.16|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.16|1.24|<0.001
71656259|NCT04168190|142830835|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>0.33 (1-sided p-value \<0.025).|GMT Ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.43|2.36|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.36|1.43|<0.001
71656260|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.03|||<|0.001|TWO_SIDED|95.0|4.23|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|4.23|<0.001
71656261|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|6.8|||<|0.001|TWO_SIDED|95.0|5.37|8.62|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||8.62|5.37|<0.001
71827518|NCT05046132|143159185|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.9|5.7||||||1 hr Post dose||5.7|-1.9|
71827519|NCT05046132|143159185|OTHER||LS Mean|6.5|||||TWO_SIDED|90.0|2.6|10.4||||||1.5 hr Post dose||10.4|2.6|
71712805|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.134|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.134
71827520|NCT05046132|143159185|OTHER||LS Mean|5.3|||||TWO_SIDED|90.0|1.3|9.3||||||2 hr Post dose||9.3|1.3|
71712806|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.31|||<|0.001|TWO_SIDED|95.0|1.0|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|1.00|<0.001
71712807|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.05|-0.40|0.135
71712808|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.84|1.5||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.50|0.84|<0.001
71712809|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|-0.25||||0.036|TWO_SIDED|95.0|-0.49|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-0.49|0.036
71712810|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.61|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.61|<0.001
71712811|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.064|TWO_SIDED|95.0|-0.46|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.01|-0.46|0.064
71712812|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.52|1.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.18|0.52|<0.001
71712813|NCT01098747|142942109|SUPERIORITY_OR_OTHER||LS mean difference|-0.22||||0.074|TWO_SIDED|95.0|-0.46|0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.02|-0.46|0.074
71712814|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.26|1.04||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.04|0.26|0.001
71712815|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.75|0.18|0.001
71712816|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|2.41|||<|0.001|TWO_SIDED|95.0|1.82|3.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.01|1.82|<0.001
71827521|NCT05046132|143159185|OTHER||LS Mean|11.1|||||TWO_SIDED|90.0|7.0|15.1||||||2.5 hr Post dose||15.1|7.0|
71827522|NCT05046132|143159185|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.6||||||3 hr Post dose||13.6|5.9|
71827523|NCT05046132|143159185|OTHER||LS Mean|10.7|||||TWO_SIDED|90.0|7.2|14.2||||||4 hr Post dose||14.2|7.2|
71712817|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|0.91|||<|0.001|TWO_SIDED|95.0|0.48|1.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.34|0.48|<0.001
71766491|NCT02204124|143034534|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #2 is for wound infection.||||0.401
71766492|NCT02204124|143034534|SUPERIORITY|||||||0.975|||||||Chi-squared|||Statistical analysis #3 is for gastroparesis.||||0.975
71766493|NCT02204124|143034534|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #4 is for pancreatic fistula.||||0.401
71766494|NCT02204124|143034534|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #5 is for intraabdominal abscess.||||0.219
71766495|NCT02204124|143034534|SUPERIORITY|||||||0.401|||||||Chi-squared|||Statistical analysis #6 is for anastomotic leakage.||||0.401
71827524|NCT05046132|143159185|OTHER||LS Mean|8.8|||||TWO_SIDED|90.0|4.9|12.7||||||5 hr Post dose||12.7|4.9|
71827525|NCT05046132|143159185|OTHER||LS Mean|11.0|||||TWO_SIDED|90.0|7.5|14.5||||||6 hr Post dose||14.5|7.5|
71827526|NCT05046132|143159185|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|7.1|14.6||||||7 hr Post dose||14.6|7.1|
71827527|NCT05046132|143159185|OTHER||LS Mean|11.3|||||TWO_SIDED|90.0|7.6|14.9||||||8 hr Post dose||14.9|7.6|
71827528|NCT05046132|143159185|OTHER||LS Mean|9.8|||||TWO_SIDED|90.0|5.9|13.7||||||9 hr Post dose||13.7|5.9|
71827529|NCT05046132|143159185|OTHER||LS Mean|10.5|||||TWO_SIDED|90.0|6.9|14.1||||||10 hr Post dose||14.1|6.9|
71827530|NCT05046132|143159185|OTHER||LS Mean|11.8|||||TWO_SIDED|90.0|8.4|15.2||||||12 hr Post dose||15.2|8.4|
71827531|NCT05046132|143159185|OTHER||LS Mean|9.4|||||TWO_SIDED|90.0|5.6|13.3||||||16 hr Post dose||13.3|5.6|
71827532|NCT05046132|143159185|OTHER||LS Mean|10.8|||||TWO_SIDED|90.0|6.8|14.9||||||24 hr Post dose||14.9|6.8|
71827533|NCT05046132|143159186|OTHER||LS Mean|-5.3|||||TWO_SIDED|90.0|-8.4|-2.2||||||Pre dose||-2.2|-8.4|
71827534|NCT05046132|143159186|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.9|0.5||||||0.5 hr Post dose||0.5|-5.9|
71827535|NCT05046132|143159186|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-5.7|-0.7||||||1 hr Post dose||-0.7|-5.7|
71827536|NCT05046132|143159186|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-3.7|1.9||||||1.5 hr Post dose||1.9|-3.7|
71827537|NCT05046132|143159186|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-5.7|-0.2||||||2 hr Post dose||-0.2|-5.7|
71827538|NCT05046132|143159186|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.5|-1.5||||||2.5 hr Post dose||-1.5|-6.5|
71827539|NCT05046132|143159186|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.1|-1.3||||||3 hr Post dose||-1.3|-7.1|
71827540|NCT05046132|143159186|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||4 hr Post dose||-0.8|-7.4|
71827541|NCT05046132|143159186|OTHER||LS Mean|-0.8|||||TWO_SIDED|90.0|-3.7|2.1||||||5 hr Post dose||2.1|-3.7|
71712818|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|3.03|4.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.33|3.03|<0.001
71712819|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|0.64||||0.008|TWO_SIDED|95.0|0.17|1.11||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.11|0.17|0.008
71827542|NCT05046132|143159186|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.3|-0.4||||||6 hr Post dose||-0.4|-6.3|
71827543|NCT05046132|143159186|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.0|-0.5||||||7 hr Post dose||-0.5|-6.0|
71827544|NCT05046132|143159186|OTHER||LS Mean|-1.6|||||TWO_SIDED|90.0|-4.7|1.5||||||8 hr Post dose||1.5|-4.7|
71827545|NCT05046132|143159186|OTHER||LS Mean|-4.0|||||TWO_SIDED|90.0|-6.9|-1.2||||||9 hr Post dose||-1.2|-6.9|
71827546|NCT05046132|143159186|OTHER||LS Mean|-4.3|||||TWO_SIDED|90.0|-7.6|-1.0||||||10 hr Post dose||-1.0|-7.6|
71827547|NCT05046132|143159186|OTHER||LS Mean|-5.4|||||TWO_SIDED|90.0|-8.7|-2.1||||||12 hr Post dose||-2.1|-8.7|
71827548|NCT05046132|143159186|OTHER||LS Mean|-4.1|||||TWO_SIDED|90.0|-7.4|-0.8||||||16 hr Post dose||-0.8|-7.4|
71827549|NCT05046132|143159186|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.1|-4.2||||||24 hr Post dose||-4.2|-10.1|
71827550|NCT05046132|143159186|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.0|4.2||||||Pre dose||4.2|-2.0|
71827551|NCT05046132|143159186|OTHER||LS Mean|3.1|||||TWO_SIDED|90.0|-0.1|6.3||||||0.5 hr Post dose||6.3|-0.1|
71827552|NCT05046132|143159186|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-0.1|4.9||||||1 hr Post dose||4.9|-0.1|
71827553|NCT05046132|143159186|OTHER||LS Mean|3.0|||||TWO_SIDED|90.0|0.2|5.8||||||1.5 hr Post dose||5.8|0.2|
71827554|NCT05046132|143159186|OTHER||LS Mean|1.8|||||TWO_SIDED|90.0|-1.0|4.6||||||2 hr Post dose||4.6|-1.0|
71827555|NCT05046132|143159186|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.9|3.1||||||2.5 hr Post dose||3.1|-1.9|
71827556|NCT05046132|143159186|OTHER||LS Mean|1.9|||||TWO_SIDED|90.0|-1.0|4.8||||||3 hr Post dose||4.8|-1.0|
71827557|NCT05046132|143159186|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-3.5|3.0||||||4 hr Post dose||3.0|-3.5|
71827558|NCT05046132|143159186|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-2.6|3.2||||||5 hr Post dose||3.2|-2.6|
71766496|NCT02204124|143034534|SUPERIORITY|||||||0.219|||||||Chi-squared|||Statistical analysis #7 is for blood product transfusion (anemia).||||0.219
71827559|NCT05046132|143159186|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-4.8|1.1||||||6 hr Post dose||1.1|-4.8|
71827560|NCT05046132|143159186|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-3.8|1.7||||||7 hr Post dose||1.7|-3.8|
71827561|NCT05046132|143159186|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.6|2.6||||||8 hr Post dose||2.6|-3.6|
71827562|NCT05046132|143159186|OTHER||LS Mean|-2.7|||||TWO_SIDED|90.0|-5.6|0.2||||||9 hr Post dose||0.2|-5.6|
71827563|NCT05046132|143159186|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.8|-0.2||||||10 hr Post dose||-0.2|-6.8|
71827564|NCT05046132|143159186|OTHER||LS Mean|-3.3|||||TWO_SIDED|90.0|-6.6|0.1||||||12 hr Post dose||0.1|-6.6|
71827565|NCT05046132|143159186|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||16 hr Post dose||3.6|-3.0|
71827566|NCT05046132|143159186|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.0|2.9||||||24 hr Post dose||2.9|-3.0|
71827567|NCT05046132|143159187|OTHER||LS Mean|-6.6|||||TWO_SIDED|90.0|-10.3|-3.0||||||Pre dose||-3.0|-10.3|
71827568|NCT05046132|143159187|OTHER||LS Mean|-7.3|||||TWO_SIDED|90.0|-10.5|-4.0||||||0.5 hr Post dose||-4.0|-10.5|
71827569|NCT05046132|143159187|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.8|-1.2||||||1 hr Post dose||-1.2|-8.8|
71827570|NCT05046132|143159187|OTHER||LS Mean|-5.0|||||TWO_SIDED|90.0|-8.4|-1.6||||||1.5 hr Post dose||-1.6|-8.4|
71827571|NCT05046132|143159187|OTHER||LS Mean|-3.5|||||TWO_SIDED|90.0|-6.6|-0.3||||||2 hr Post dose||-0.3|-6.6|
71827572|NCT05046132|143159187|OTHER||LS Mean|-2.9|||||TWO_SIDED|90.0|-6.1|0.3||||||2.5 hr Post dose||0.3|-6.1|
71827573|NCT05046132|143159187|OTHER||LS Mean|-4.6|||||TWO_SIDED|90.0|-7.7|-1.5||||||3 hr Post dose||-1.5|-7.7|
71827574|NCT05046132|143159187|OTHER||LS Mean|-7.1|||||TWO_SIDED|90.0|-10.3|-3.8||||||4 hr Post dose||-3.8|-10.3|
71827575|NCT05046132|143159187|OTHER||LS Mean|-3.2|||||TWO_SIDED|90.0|-6.9|0.6||||||5 hr Post dose||0.6|-6.9|
71827576|NCT05046132|143159187|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.8|-0.6||||||6 hr Post dose||-0.6|-7.8|
71827577|NCT05046132|143159187|OTHER||LS Mean|-4.8|||||TWO_SIDED|90.0|-8.1|-1.6||||||7 hr Post dose||-1.6|-8.1|
71827578|NCT05046132|143159187|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||8 hr Post dose||-1.1|-7.8|
71827579|NCT05046132|143159187|OTHER||LS Mean|-5.9|||||TWO_SIDED|90.0|-9.3|-2.6||||||9 hr Post dose||-2.6|-9.3|
71827580|NCT05046132|143159187|OTHER||LS Mean|-4.4|||||TWO_SIDED|90.0|-7.8|-1.1||||||10 hr Post dose||-1.1|-7.8|
71827581|NCT05046132|143159187|OTHER||LS Mean|-4.2|||||TWO_SIDED|90.0|-7.3|-1.1||||||12 hr Post dose||-1.1|-7.3|
71827582|NCT05046132|143159187|OTHER||LS Mean|-5.8|||||TWO_SIDED|90.0|-9.7|-2.0||||||16 hr Post dose||-2.0|-9.7|
71827583|NCT05046132|143159187|OTHER||LS Mean|-8.2|||||TWO_SIDED|90.0|-12.5|-3.8||||||24 hr Post dose||-3.8|-12.5|
71827584|NCT05046132|143159187|OTHER||LS Mean|2.4|||||TWO_SIDED|90.0|-1.2|5.9||||||Pre dose||5.9|-1.2|
71827585|NCT05046132|143159187|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-4.5|1.8||||||0.5 hr Post dose||1.8|-4.5|
71827586|NCT05046132|143159187|OTHER||LS Mean|-0.4|||||TWO_SIDED|90.0|-4.0|3.3||||||1 hr Post dose||3.3|-4.0|
71827587|NCT05046132|143159187|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-3.0|3.6||||||1.5 hr Post dose||3.6|-3.0|
71712820|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.4|4.72||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.72|3.40|<0.001
71712821|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|0.58||||0.017|TWO_SIDED|95.0|0.1|1.06||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.06|0.10|0.017
71827588|NCT05046132|143159187|OTHER||LS Mean|-1.0|||||TWO_SIDED|90.0|-4.0|2.0||||||2 hr Post dose||2.0|-4.0|
71827589|NCT05046132|143159187|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-2.6|3.6||||||2.5 hr Post dose||3.6|-2.6|
71827590|NCT05046132|143159187|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-3.7|2.3||||||3 hr Post dose||2.3|-3.7|
71827591|NCT05046132|143159187|OTHER||LS Mean|-2.3|||||TWO_SIDED|90.0|-5.4|0.9||||||4 hr Post dose||0.9|-5.4|
71827592|NCT05046132|143159187|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-2.5|4.6||||||5 hr Post dose||4.6|-2.5|
71827593|NCT05046132|143159187|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-4.1|2.8||||||6 hr Post dose||2.8|-4.1|
71827594|NCT05046132|143159187|OTHER||LS Mean|-1.9|||||TWO_SIDED|90.0|-5.0|1.3||||||7 hr Post dose||1.3|-5.0|
71827595|NCT05046132|143159187|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-3.7|2.8||||||8 hr Post dose||2.8|-3.7|
71827596|NCT05046132|143159187|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-3.4|3.1||||||9 hr Post dose||3.1|-3.4|
71827597|NCT05046132|143159187|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-2.8|3.7||||||10 hr Post dose||3.7|-2.8|
71827598|NCT05046132|143159187|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-2.9|3.1||||||12 hr Post dose||3.1|-2.9|
71827599|NCT05046132|143159187|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-3.1|4.3||||||16 hr Post dose||4.3|-3.1|
71827600|NCT05046132|143159187|OTHER||LS Mean|1.7|||||TWO_SIDED|90.0|-2.5|5.9||||||24 hr Post dose||5.9|-2.5|
71827601|NCT05046132|143159188|OTHER||LS Mean|-0.7|||||TWO_SIDED|90.0|-2.6|1.2||||||Pre dose||1.2|-2.6|
71712822|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|4.09|||<|0.001|TWO_SIDED|95.0|3.42|4.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.75|3.42|<0.001
71827602|NCT05046132|143159188|OTHER||LS Mean|-0.9|||||TWO_SIDED|90.0|-2.6|0.7||||||0.5 hr post dose||0.7|-2.6|
71827603|NCT05046132|143159188|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.3||||||1 hr post dose||2.3|-1.1|
71827604|NCT05046132|143159188|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.5|1.3||||||1.5 hr post dose||1.3|-1.5|
71827605|NCT05046132|143159188|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.8|2.4||||||2 hr post dose||2.4|-0.8|
71827606|NCT05046132|143159188|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||2.5 hr post dose||2.4|-1.0|
71827607|NCT05046132|143159188|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.6|2.0||||||3 hr post dose||2.0|-1.6|
71827608|NCT05046132|143159188|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.9|2.3||||||4 hr post dose||2.3|-0.9|
71827609|NCT05046132|143159188|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.1||||||5 hr post dose||2.1|-1.2|
71827610|NCT05046132|143159188|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.7|2.4||||||6 hr post dose||2.4|-0.7|
71827611|NCT05046132|143159188|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.4||||||7 hr post dose||2.4|-0.6|
71827612|NCT05046132|143159188|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.0|2.2||||||8 hr post dose||2.2|-1.0|
71827613|NCT05046132|143159188|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
71827614|NCT05046132|143159188|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.5|1.6||||||10 hr post dose||1.6|-1.5|
71827615|NCT05046132|143159188|OTHER||LS Mean|1.4|||||TWO_SIDED|90.0|-0.2|3.0||||||12 hr post dose||3.0|-0.2|
71827616|NCT05046132|143159188|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||16 hr post dose||3.4|-0.3|
71827617|NCT05046132|143159188|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-2.1|1.6||||||24 hr post dose||1.6|-2.1|
71827618|NCT05046132|143159188|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.2|2.6||||||Pre dose||2.6|-1.2|
71827619|NCT05046132|143159188|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.9|1.4||||||0.5 hr post dose||1.4|-1.9|
71827620|NCT05046132|143159188|OTHER||LS Mean|0.5|||||TWO_SIDED|90.0|-1.2|2.2||||||1 hr post dose||2.2|-1.2|
71827621|NCT05046132|143159188|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.7|2.1||||||1.5 hr post dose||2.1|-0.7|
71827622|NCT05046132|143159188|OTHER||LS Mean|0.6|||||TWO_SIDED|90.0|-1.1|2.2||||||2 hr post dose||2.2|-1.1|
71827623|NCT05046132|143159188|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.9|2.5||||||2.5 hr post dose||2.5|-0.9|
71827624|NCT05046132|143159188|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.5|2.1||||||3 hr post dose||2.1|-1.5|
71827625|NCT05046132|143159188|OTHER||LS Mean|-0.5|||||TWO_SIDED|90.0|-2.1|1.1||||||4 hr post dose||1.1|-2.1|
71827626|NCT05046132|143159188|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.5|1.9||||||5 hr post dose||1.9|-1.5|
71827627|NCT05046132|143159188|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.7|1.4||||||6 hr post dose||1.4|-1.7|
71827628|NCT05046132|143159188|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.4||||||7 hr post dose||1.4|-1.6|
71827629|NCT05046132|143159188|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-0.7|2.4||||||8 hr post dose||2.4|-0.7|
71827630|NCT05046132|143159188|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.6|1.3||||||9 hr post dose||1.3|-1.6|
71827631|NCT05046132|143159188|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.4|1.6||||||10 hr post dose||1.6|-1.4|
71766497|NCT01250496|143034535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.45||||0.04|TWO_SIDED|95.0|0.2|0.98||No adjustment for multiple comparisons was performed. The threshold for statistical significance was \< 0.05|Chi-squared|||null hypothesis: aminophylline administration does not reduce the incidence of the primary endpoint as compared to placebo. The chi-square test was used to compare event rate between the study arm.||0.98|0.2|0.04
71766498|NCT01250496|143034536|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.2|0.7||P value is not adjusted for multiple comparisons.|Chi-squared|||"null hypothesis: the rate of regadenoson adverse effects (global symptomatic burden) in the aminophylline and placebo group are not statistically different.~The chi-square test was used for comparison."||0.7|0.2|< 0.001
71766499|NCT01425463|143034539|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.|LS-Mean of ANCOVA|-2.19|||||TWO_SIDED|95.0|-8.47|4.09||||||||4.09|-8.47|
71766500|NCT00791973|143034559|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon signed-rank test|||||||0.33
71766501|NCT00791973|143034560|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon signed-rank test|||||||0.14
71827632|NCT05046132|143159188|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.1|3.1||||||12 hr post dose||3.1|-0.1|
71827633|NCT05046132|143159188|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-0.7|3.0||||||16 hr post dose||3.0|-0.7|
71827634|NCT05046132|143159188|OTHER||LS Mean|1.5|||||TWO_SIDED|90.0|-0.3|3.4||||||24 hr post dose||3.4|-0.3|
71827635|NCT05046132|143159189|OTHER||LS Mean|0.8|||||TWO_SIDED|90.0|-1.3|2.9||||||Pre dose||2.9|-1.3|
71827636|NCT05046132|143159189|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-1.8|1.2||||||0.5 hr post dose||1.2|-1.8|
71827637|NCT05046132|143159189|OTHER||LS Mean|1.2|||||TWO_SIDED|90.0|-1.4|3.8||||||1 hr post dose||3.8|-1.4|
71766502|NCT01087736|143034696|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.89||||0.019|TWO_SIDED|95.0|0.89|0.98||We tested our Primary hypothesis with a random-intercept repeated subject negative binomial model, modeling week (baseline - week 12) as a continuous variable. All analyses were intent-to-treat and used all observations from all weeks.|negative binomial regression|||Our primary protocol-defined analysis was to examine the within-group efficacy of topiramate to reduce percent drinking days (%DD).||0.98|0.89|0.019
71766503|NCT01087736|143034696|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There were no pre hoc hypothesis regarding change within placebo group. We were only tested change within the topiramate condition.||||0.00
71766504|NCT01087736|143034696|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.38||||0.036|TWO_SIDED|95.0|0.15|0.94|||Negative binomial model|||"A secondary analysis was powered to detect a Signal or statistical trend (p\<0.10) for a difference between the topiramate and placebo condition. We compared percent drinking days per week between groups averaged over the active phase of the trial (weeks 1-12). The negative binomial model included fixed effect for week, treatment group, and the interaction between treatment group and week. We covaried for baseline %DD averages to control for prestudy and study enrollment effects."||0.94|0.15|0.036
71766505|NCT01087736|143034697|SUPERIORITY_OR_OTHER||||||<|0.026|||||||Mixed Models Analysis|||We planned to explore the efficacy of topiramate in reducing PTSD symptom severity. We used random-intercept linear mixed models to explore the efficacy for topiramate related reduction in PTSD symptomatology. We looked for an effect of week within TOP. Baseline scores for PTSD symptoms were used as covariates in group comparisons. All analyses were intent-to-treat and used all observations from all weeks.||||<0.026
71766506|NCT01087736|143034697|SUPERIORITY_OR_OTHER|||||||0|||||||Other|||There was not a pre hoc hypothesis regarding change within placebo group. We only examined within group change in the topiramate condition.||||0.00
71766507|NCT01101308|143034711|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|97.51|107.27|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||107.27|97.51|
71766508|NCT01101308|143034712|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.19|103.0|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||103.00|97.19|
71766509|NCT01101308|143034713|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|97.14|102.99|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||102.99|97.14|
71766510|NCT02673541|143034787|OTHER|||||||1|||||||Fisher Exact|||||||1
71827638|NCT05046132|143159189|OTHER||LS Mean|0.0|||||TWO_SIDED|90.0|-1.8|1.8||||||1.5 hr post dose||1.8|-1.8|
71766511|NCT02112045|143034795|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
71766512|NCT02112045|143034796|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
71827639|NCT05046132|143159189|OTHER||LS Mean|-1.4|||||TWO_SIDED|90.0|-3.0|0.3||||||2 hr post dose||0.3|-3.0|
71827640|NCT05046132|143159189|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|0.0|3.1||||||2.5 hr post dose||3.1|-0.0|
71827641|NCT05046132|143159189|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.7|1.5||||||3 hr post dose||1.5|-1.7|
71827642|NCT05046132|143159189|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.3|2.9||||||4 hr post dose||2.9|-0.3|
71827643|NCT05046132|143159189|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-2.2|2.0||||||5 hr post dose||2.0|-2.2|
71827644|NCT05046132|143159189|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||6 hr post dose||2.3|-0.8|
71827645|NCT05046132|143159189|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.8|2.7||||||7 hr post dose||2.7|-0.8|
71827646|NCT05046132|143159189|OTHER||LS Mean|1.0|||||TWO_SIDED|90.0|-0.3|2.4||||||8 hr post dose||2.4|-0.3|
71827647|NCT05046132|143159189|OTHER||LS Mean|1.1|||||TWO_SIDED|90.0|-0.7|2.9||||||9 hr post dose||2.9|-0.7|
71827648|NCT05046132|143159189|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.4|1.9||||||10 hr post dose||1.9|-1.4|
71827649|NCT05046132|143159189|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|-0.6|3.2||||||12 hr post dose||3.2|-0.6|
71827650|NCT05046132|143159189|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-1.0|2.4||||||16 hr post dose||2.4|-1.0|
71827651|NCT05046132|143159189|OTHER||LS Mean|1.6|||||TWO_SIDED|90.0|-1.0|4.2||||||24 hr post dose||4.2|-1.0|
71827652|NCT05046132|143159189|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.3|1.7||||||Pre dose||1.7|-2.3|
71766513|NCT00977080|143034799|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the IV stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.016
71766514|NCT00977080|143034799|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|95.0||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.||||0.260
71766515|NCT00977080|143034800|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71766516|NCT00977080|143034800|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Fisher Exact|||||||0.239
71766517|NCT00977080|143034801|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71827653|NCT05046132|143159189|OTHER||LS Mean|-0.1|||||TWO_SIDED|90.0|-1.6|1.3||||||0.5 hr post dose||1.3|-1.6|
71827654|NCT05046132|143159189|OTHER||LS Mean|-1.3|||||TWO_SIDED|90.0|-3.8|1.2||||||1 hr post dose||1.2|-3.8|
71827655|NCT05046132|143159189|OTHER||LS Mean|0.1|||||TWO_SIDED|90.0|-1.7|1.8||||||1.5 hr post dose||1.8|-1.7|
71827656|NCT05046132|143159189|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||2 hr post dose||0.5|-2.7|
71766518|NCT00977080|143034801|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||Fisher Exact|||||||0.704
71766519|NCT00977080|143034802|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.010
71766520|NCT00977080|143034803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71766521|NCT00977080|143034803|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71766522|NCT00977080|143034804|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Fisher Exact|||||||0.118
71827657|NCT05046132|143159189|OTHER||LS Mean|0.7|||||TWO_SIDED|90.0|-0.8|2.3||||||2.5 hr post dose||2.3|-0.8|
71827658|NCT05046132|143159189|OTHER||LS Mean|0.2|||||TWO_SIDED|90.0|-1.3|1.8||||||3 hr post dose||1.8|-1.3|
71827659|NCT05046132|143159189|OTHER||LS Mean|0.3|||||TWO_SIDED|90.0|-1.2|1.9||||||4 hr post dose||1.9|-1.2|
71766523|NCT00977080|143034804|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71766524|NCT00441116|143034805|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.54|STANDARD_DEVIATION|20.37||0.0319||95.0|0.75|14.33|||t-test, 2 sided||Mean difference = Drug A minus Drug B|Month 6 - Baseline||14.33|0.75|0.0319
71766525|NCT03192358|143034837|SUPERIORITY||Cohen's d|1.18|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05.|ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study. The statistical test explores whether there were significant differences in tongue pressure between the two cohorts. The hypothesis was that individuals with ALS would display significantly lower maximum anterior isometric tongue pressures compared to the people with PD.||||< 0.001
71766526|NCT03192358|143034838|SUPERIORITY||Cohen's d|1.75|||<|0.001|TWO_SIDED||||||ANOVA||Cohen's d values \> 0.8 are considered large|This was an observational study rather than a trial. The hypothesis was that individuals with ALS would display significantly lower regular effort saliva swallow pressures than the individuals with PD.||||< 0.001
71766527|NCT00392379|143034893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|STANDARD_DEVIATION|43.0|<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|Regression, Logistic|||Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).||||<0.05
71766528|NCT02342418|143034896|SUPERIORITY_OR_OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71766529|NCT02342418|143034897|SUPERIORITY_OR_OTHER|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pair signed-rank test||||0.214
71766530|NCT00428584|143034902|SUPERIORITY_OR_OTHER|||||||0.524||||||P value refers to mean change to 30 minute post injection|ANOVA|||The primary efficacy endpoint was analyzed by using a two-way ANOVA model on ranked data including treatment group and site as fixed effect.||||0.524
71766531|NCT00428584|143034903|SUPERIORITY_OR_OTHER|||||||0.484|||||||ANOVA|||||||0.484
71766532|NCT00428584|143034904|SUPERIORITY_OR_OTHER|||||||0.838|||||||ANOVA|||||||0.838
71766533|NCT00428584|143034905|SUPERIORITY_OR_OTHER|||||||0.451||||||No pain is defined as a VAS = 0 for all 21 full dose injections.|Cochran-Mantel-Haenszel|||||||0.451
71766534|NCT00428584|143034906|SUPERIORITY_OR_OTHER|||||||0.338|||||||ANOVA|||||||0.338
71766535|NCT02285062|143034918|SUPERIORITY||Hazard Ratio (HR)|0.849||||0.2864|TWO_SIDED|95.0|0.632|1.14|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors|||1.140|0.632|0.2864
71827660|NCT05046132|143159189|OTHER||LS Mean|-1.5|||||TWO_SIDED|90.0|-3.5|0.5||||||5 hr post dose||0.5|-3.5|
71827661|NCT05046132|143159189|OTHER||LS Mean|0.9|||||TWO_SIDED|90.0|-0.6|2.3||||||6 hr post dose||2.3|-0.6|
71827662|NCT05046132|143159189|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.1||||||7 hr post dose||2.1|-1.3|
71827663|NCT05046132|143159189|OTHER||LS Mean|1.3|||||TWO_SIDED|90.0|0.0|2.6||||||8 hr post dose||2.6|-0.0|
71827664|NCT05046132|143159189|OTHER||LS Mean|0.4|||||TWO_SIDED|90.0|-1.3|2.2||||||9 hr post dose||2.2|-1.3|
71827665|NCT05046132|143159189|OTHER||LS Mean|-1.1|||||TWO_SIDED|90.0|-2.7|0.5||||||10 hr post dose||0.5|-2.7|
71827666|NCT05046132|143159189|OTHER||LS Mean|-0.3|||||TWO_SIDED|90.0|-2.1|1.5||||||12 hr post dose||1.5|-2.1|
71827667|NCT05046132|143159189|OTHER||LS Mean|-0.2|||||TWO_SIDED|90.0|-1.9|1.4||||||16 hr post dose||1.4|-1.9|
71827668|NCT05046132|143159189|OTHER||LS Mean|2.3|||||TWO_SIDED|90.0|-0.2|4.9||||||24 hr post dose||4.9|-0.2|
71827669|NCT04246762|143159204|OTHER||geometric LS mean ratio of AUC (0-inf))|70.46|||||TWO_SIDED|90.0|60.62|81.91|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.91|60.62|
71827670|NCT04246762|143159204|OTHER||geometric LS mean ratio of AUC (0-inf))|67.87|||||TWO_SIDED|90.0|56.73|81.21|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||81.21|56.73|
71827671|NCT04246762|143159204|OTHER||geometric LS mean ratio of AUC (0-inf))|122.92|||||TWO_SIDED|90.0|107.98|139.93|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||139.93|107.98|
71827672|NCT04246762|143159205|OTHER||geometric LS mean ratio of AUC (0-last))|90.83|||||TWO_SIDED|90.0|86.72|95.13|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI.||95.13|86.72|
71827673|NCT04246762|143159206|OTHER||geometric LS mean ratio of Cmax|68.5|||||TWO_SIDED|90.0|59.46|78.92|||||Results based on a linear mixed model for the log-transformed values of PK parameters of midazolam with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (midazolam (as part of a 4-drug oral cocktail) after OKZ administration compared to midazolam (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||78.92|59.46|
71827674|NCT04246762|143159206|OTHER||geometric LS mean ratio of Cmax|73.54|||||TWO_SIDED|90.0|64.18|84.27|||||Results based on a linear mixed model for the log-transformed values of PK parameters of omeprazole with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (omeprazole (as part of a 4-drug oral cocktail) after OKZ administration compared to omeprazole (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||84.27|64.18|
71827675|NCT04246762|143159206|OTHER||geometric LS mean ratio of Cmax|97.99|||||TWO_SIDED|90.0|91.36|105.09|||||Results based on a linear mixed model for the log-transformed values of baseline-adjusted PK parameters of caffeine with a with fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (caffeine (as part of a 4-drug oral cocktail) after OKZ administration compared to caffeine (as part of a 4-drug oral cocktail) administrated alone) and its corresponding 90% confidence interval (CI) were calculated. The mean difference and the CI were back transformed to the original scale to obtain estimates of the geometric mean ratio and the associated 90% CI.||105.09|91.36|
71827676|NCT04246762|143159206|OTHER||geometric LS mean ratio of Cmax|102.3|||||TWO_SIDED|90.0|94.8|110.39|||||Results based on a linear mixed model for the log-transformed values of PK parameters of S-warfarin with a fixed effect for treatment and a random effect for subject.|Estimate of the mean difference between treatments (S-warfarin (as part of a 4-drug oral cocktail) after OKZ administration compared to initial S-warfarin administrated alone (as part of a 4-drug oral cocktail)) and its corresponding 90% confidence interval (CI) was calculated. The mean difference and the CI were back transformed to the original scale to obtain estimate of the geometric mean ratio and the associated 90% CI. The sample size computation was based on results reported for sirukumab.||110.39|94.80|
71827677|NCT02124460|143159237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.3928|TWO_SIDED|95.0|-0.08|0.03|||Linear repeated measures|Multiple imputation was used for missing follow-up data.|Health Coaching group compared to Enhanced Primary Care|||0.03|-0.08|0.3928
71827678|NCT02124460|143159238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.2306|TWO_SIDED|95.0|-0.56|2.33|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care|||2.33|-0.56|0.2306
71827679|NCT02124460|143159239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care.|||0.16|-0.02|.14
71827680|NCT02124460|143159240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.0016|TWO_SIDED|95.0|-0.81|-0.19|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||-0.19|-0.81|0.0016
71827681|NCT02124460|143159241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.22|0.62||Multiple imputation used for missing data at follow-up.|Linear repeated measures|||||0.62|0.22|<.0001
71766536|NCT02285062|143034919|SUPERIORITY||Hazard Ratio (HR)|1.038||||0.7294|TWO_SIDED|95.0|0.802|1.344|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.344|0.802|0.7294
71827682|NCT02124460|143159242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.3043|TWO_SIDED|95.0|-0.16|0.53|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.53|-0.16|0.3043
71827683|NCT02124460|143159243|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.0113|TWO_SIDED|95.0|0.07|0.56|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.56|0.07|0.0113
71827684|NCT02124460|143159244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.0792|TWO_SIDED|95.0|-0.45|0.03|||Linear repeated measures|Multiple imputation used for missing data at follow-up.||||0.03|-0.45|0.0792
71827685|NCT03008915|143159272|OTHER|Paired t-test for participants with measures on both aspirin and placebo.||||||0.692|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between measures on aspirin and placebo.||||0.692
71827686|NCT00712166|143159279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.433|TWO_SIDED|95.0|-2.83|6.44||"The primary endpoint analysis was based on a two-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeper approach was established a priori to control the type 1 error rate, however, the primary endpoint was not met."|ANCOVA|ANCOVA included: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Denominator degrees of freedom computed with Satterthwaite approximation.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~At the 5% significance level (i.e., α = 0.05) using a two-sided significance test, a sample size of 70 participants per treatment group provided at least 90% power to detect a 10 point difference between groups in the mean change from baseline at Day 28 in the CFQ-R RSS score, assuming a common standard deviation (SD) of 17.5."||6.44|-2.83|0.433
71712823|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.359|TWO_SIDED|95.0|-0.26|0.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.70|-0.26|0.359
71712824|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|3.06|4.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.45|3.06|<0.001
71712825|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.436|TWO_SIDED|95.0|-0.7|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.30|-0.70|0.436
71712826|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|3.4|||<|0.001|TWO_SIDED|95.0|2.66|4.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|2.66|<0.001
71712827|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|-0.4||||0.139|TWO_SIDED|95.0|-0.93|0.13||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.13|-0.93|0.139
71827687|NCT00712166|143159280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.37||||0.133|TWO_SIDED|95.0|-1.04|7.78||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included terms: treatment, baseline CFQ-R RSS, age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 14.||7.78|-1.04|0.133
71827688|NCT00712166|143159281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965|TWO_SIDED|95.0|-4.56|4.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment, baseline CFQ-R RSS and age group (\<18 years, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 42.||4.76|-4.56|0.965
71827689|NCT00712166|143159282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47||||0.256||95.0|-1.81|6.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included: treatment, baseline CFQ-R Physical Function Domain score and age (\<18, \>=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R physical functioning domain score at Day 28.||6.76|-1.81|0.256
71827690|NCT00712166|143159283|SUPERIORITY_OR_OTHER||||||>|0.999||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple usage was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||>0.999
71827691|NCT00712166|143159284|SUPERIORITY_OR_OTHER|||||||0.122||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple hospitalizations was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in proportion of participants hospitalized.||||0.122
71827692|NCT00712166|143159287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.016|TWO_SIDED|95.0|-2.2|-0.23||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline log10 CFU, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the log10 CFU at Day 28.||-0.23|-2.20|0.016
71827693|NCT00712166|143159288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73||||0.021|TWO_SIDED|95.0|0.42|5.04||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model includes treatment, baseline FEV1 % predicted, and age group (\<18, \>=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in % change from baseline in FEV1 % predicted at Day 28.||5.04|0.42|0.021
71827694|NCT01264718|143159294|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|6.0|||||TWO_SIDED||||||||The estimated value is the savings per child per year insured.|||||
71712828|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||<|0.001|TWO_SIDED|95.0|2.44|3.95||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.95|2.44|<0.001
71712829|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|-0.41||||0.144|TWO_SIDED|95.0|-0.95|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.14|-0.95|0.144
71712830|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|2.8|||<|0.001|TWO_SIDED|95.0|2.01|3.58||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.58|2.01|<0.001
71712831|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|-0.58||||0.043|TWO_SIDED|95.0|-1.15|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.15|0.043
71712832|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|2.33|||<|0.001|TWO_SIDED|95.0|1.53|3.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|1.53|<0.001
71712833|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|-0.59||||0.044|TWO_SIDED|95.0|-1.16|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.02|-1.16|0.044
71712834|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.25|2.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.85|1.25|<0.001
71712835|NCT01098747|142942110|SUPERIORITY_OR_OTHER||LS mean difference|-0.65||||0.027|TWO_SIDED|95.0|-1.23|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||-0.08|-1.23|0.027
71712836|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||<|0.001|TWO_SIDED|95.0|2.27|3.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.18|2.27|<0.001
71712837|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.007|TWO_SIDED|95.0|0.12|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.12|0.007
71712838|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|4.29|||<|0.001|TWO_SIDED|95.0|3.6|4.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.98|3.60|<0.001
71712839|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.144|TWO_SIDED|95.0|-0.13|0.87||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.13|0.144
71712840|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|8.16|||<|0.001|TWO_SIDED|95.0|6.66|9.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.66|6.66|<0.001
71766537|NCT02285062|143034920|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.876|TWO_SIDED|95.0|0.716|1.3|||Log Rank|Log-rank test stratified by 3 factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.|||1.300|0.716|0.8760
71766538|NCT02285062|143034921|SUPERIORITY|||||||0.2933||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.2933
71827695|NCT01264718|143159294|OTHER|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|4.0|||||TWO_SIDED||||||||The estimated value is the savings for each percent increase in children obtaining insurance per year.|||||
71827696|NCT01144182|143159304|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED|||||For this pilot study, significance level was set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||.56
71827697|NCT01144182|143159305|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.22
71712841|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|-0.23||||0.679|TWO_SIDED|95.0|-1.31|0.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.85|-1.31|0.679
71712842|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|9.94|||<|0.001|TWO_SIDED|95.0|7.92|11.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.96|7.92|<0.001
71712843|NCT01098747|142942111|SUPERIORITY_OR_OTHER||LS mean difference|-0.67||||0.367|TWO_SIDED|95.0|-2.12|0.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.79|-2.12|0.367
71712844|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||<|0.001|TWO_SIDED|95.0|3.32|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|3.32|< 0.001
71712845|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|0.62||||0.009|TWO_SIDED|95.0|0.16|1.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.07|0.16|0.009
71712846|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|6.15|||<|0.001|TWO_SIDED|95.0|5.18|7.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.12|5.18|<0.001
71712847|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.166|TWO_SIDED|95.0|-0.21|1.2||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.20|-0.21|0.166
71712848|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|11.67|||<|0.001|TWO_SIDED|95.0|9.54|13.81||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.81|9.54|<0.001
71712849|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|-0.3||||0.703|TWO_SIDED|95.0|-1.84|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|-1.84|0.703
71712850|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|14.27|||<|0.001|TWO_SIDED|95.0|11.36|17.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||17.18|11.36|<0.001
71712851|NCT01098747|142942112|SUPERIORITY_OR_OTHER||LS mean difference|-1.1||||0.303|TWO_SIDED|95.0|-3.2|1.0||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.00|-3.20|0.303
71712852|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|6.68|||<|0.001|TWO_SIDED|95.0|5.6|7.76||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||7.76|5.60|<0.001
71712853|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.007|TWO_SIDED|95.0|0.29|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.84|0.29|0.007
71827698|NCT01144182|143159306|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
71712854|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|8.79|12.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||12.08|8.79|<0.001
71766539|NCT02285062|143034922|SUPERIORITY|||||||0.9964||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (\< 65 or ≥ 65)|Cochran-Mantel-Haenszel|||||||0.9964
71827699|NCT01144182|143159307|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
71827700|NCT01144182|143159308|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
71827701|NCT01144182|143159309|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
71827702|NCT01144182|143159310|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
71827703|NCT01144182|143159311|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
71827704|NCT01144182|143159312|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.56
71827705|NCT01144182|143159313|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
71712855|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|0.87||||0.152|TWO_SIDED|95.0|-0.32|2.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.05|-0.32|0.152
71712856|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|19.83|||<|0.001|TWO_SIDED|95.0|16.23|23.43||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||23.43|16.23|<0.001
71712857|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|-0.53||||0.69|TWO_SIDED|95.0|-3.12|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||2.07|-3.12|0.690
71712858|NCT01098747|142942113|SUPERIORITY_OR_OTHER||LS mean difference|-1.77||||0.323|TWO_SIDED|95.0|-5.29|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-8 Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.||1.75|-5.29|0.323
71712859|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|1.01||||0.49|TWO_SIDED|95.0|-0.97|3.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.00|-0.97|0.490
71712860|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|0.54||||0.623|TWO_SIDED|95.0|-1.88|2.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.95|-1.88|0.623
71712861|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|24.36|||<|0.001|TWO_SIDED|95.0|13.51|35.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||35.22|13.51|<0.001
71766540|NCT02285062|143034923|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2143|TWO_SIDED|95.0|0.521|1.157|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR was derived from COX model adjusting for the 3 stratification factors mentioned above.|||1.157|0.521|0.2143
71766541|NCT02285062|143034924|SUPERIORITY||Hazard Ratio (HR)|1.167||||0.315||95.0|0.856|1.59|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or \< 7 cm), and age (\< 65 or ≥ 65 years).|HR is derived from Cox model|||1.590|0.856|0.3150
71712862|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|11.82||||0.023|TWO_SIDED|95.0|1.15|22.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.48|1.15|0.023
71712863|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|61.35|||<|0.001|TWO_SIDED|95.0|48.99|73.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.70|48.99|<0.001
71712864|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|21.25|||<|0.001|TWO_SIDED|95.0|9.58|32.92||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.92|9.58|<0.001
71712865|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|72.65|||<|0.001|TWO_SIDED|95.0|61.59|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|61.59|<0.001
71766542|NCT00821509|143034939|SUPERIORITY_OR_OTHER||ratio of proportions|1.03||||0.004|||||||proportion test|The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm||According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.004
71766543|NCT00821509|143034940|SUPERIORITY_OR_OTHER||ratio of proportions|0.933||||0.04|||||||proportion test|||According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.||||0.04
71827706|NCT01144182|143159314|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.15
71827707|NCT01144182|143159315|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
71827708|NCT01144182|143159316|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.36
71827709|NCT03546907|143159322|SUPERIORITY||Risk Ratio (RR)|0.808||||0.1296|TWO_SIDED|95.0|0.613|1.065|||Negative binomial regression model|||Analysis was performed using negative binomial regression model with total number of events occurring during observation duration as response variable, treatment, baseline eosinophil strata, region, number of severe COPD exacerbations experienced in previous year(0 vs. 1+) at baseline, smoking history(current vs. former smoker), post-BD FEV1 percent(%) predicted (less than\[\<\] 50% vs greater than equal\[\>=\]50%) at baseline as covariates, and log-transformed observation duration as offset variable.||1.065|0.613|0.1296
71827710|NCT03110458|143159356|SUPERIORITY|||||||0.8466|||||||ANCOVA|||||||0.8466
71827711|NCT03110458|143159357|SUPERIORITY|||||||0.9538|||||||ANCOVA|||||||0.9538
71656262|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.31|3.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.90|2.31|<0.001
71656263|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|18.21|||<|0.001|TWO_SIDED|95.0|12.98|25.57|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||25.57|12.98|<0.001
71656264|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|19.45|||<|0.001|TWO_SIDED|95.0|12.87|29.4|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.40|12.87|<0.001
71656265|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|29.88|||<|0.001|TWO_SIDED|95.0|20.72|43.09|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||43.09|20.72|<0.001
71656266|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|32.02|||<|0.001|TWO_SIDED|95.0|22.83|44.89|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||44.89|22.83|<0.001
71656267|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|34.9|||<|0.001|TWO_SIDED|95.0|24.25|50.23|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||50.23|24.25|<0.001
71656268|NCT04168190|142830836|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMT Ratio|9.0|||<|0.001|TWO_SIDED|95.0|7.19|11.26|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean titer (GMT) ratio and 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||11.26|7.19|<0.001
71656269|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.58|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.42|0.58|
71656270|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.71|1.76|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.76|0.71|
71656271|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.63|1.99|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.99|0.63|
71656272|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.19|3.84|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||3.84|1.19|
71656273|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.27|||||TWO_SIDED|95.0|0.74|2.21|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||2.21|0.74|
71656274|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.08|||||TWO_SIDED|95.0|1.19|3.63|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||3.63|1.19|
71656275|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.37|1.46|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||1.46|0.37|
71656276|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.5|2.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||2.00|0.50|
71656277|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.4|1.41|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.41|0.40|
71656278|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.32|||||TWO_SIDED|95.0|0.7|2.48|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||2.48|0.70|
71827712|NCT03110458|143159358|SUPERIORITY|||||||0.3166|||||||ANCOVA|||||||0.3166
71656279|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.37|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.37|
71656280|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.58|1.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.69|0.58|
71656281|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.57|1.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||1.85|0.57|
71656282|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.64|||||TWO_SIDED|95.0|0.9|2.97|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.97|0.90|
71656283|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.25|||||TWO_SIDED|95.0|0.67|2.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.32|0.67|
71656284|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.84|||||TWO_SIDED|95.0|0.98|3.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.45|0.98|
71656285|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.42|1.38|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.38|0.42|
71656286|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.59|||||TWO_SIDED|95.0|0.87|2.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||2.91|0.87|
71656287|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.5|2.17|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||2.17|0.50|
71656288|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.14|||||TWO_SIDED|95.0|1.02|4.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.50|1.02|
71656289|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.11|||||TWO_SIDED|95.0|1.21|3.68|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.68|1.21|
71656290|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|2.87|||||TWO_SIDED|95.0|1.64|5.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||5.03|1.64|
71656291|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.65|||||TWO_SIDED|95.0|0.93|2.93|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||2.93|0.93|
71656292|NCT04168190|142830837|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.07|3.43|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||3.43|1.07|
71656293|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.29|||||TWO_SIDED|95.0|1.99|9.25|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||9.25|1.99|
71656294|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.49|||||TWO_SIDED|95.0|2.53|11.91|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||11.91|2.53|
71656295|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|5.05|||||TWO_SIDED|95.0|2.59|9.85|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||9.85|2.59|
71656296|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|4.55|17.5|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||17.50|4.55|
71656297|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.4|||||TWO_SIDED|95.0|2.38|8.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||8.15|2.38|
71656298|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.92|||||TWO_SIDED|95.0|2.64|9.16|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||9.16|2.64|
71656299|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.41|||||TWO_SIDED|95.0|1.97|5.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||5.91|1.97|
71656300|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|6.58|||||TWO_SIDED|95.0|3.78|11.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.45|3.78|
71656301|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.42|||||TWO_SIDED|95.0|4.35|20.4|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||20.40|4.35|
71656302|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.46|||||TWO_SIDED|95.0|4.34|20.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||20.62|4.34|
71827713|NCT03110458|143159359|SUPERIORITY|||||||0.393|||||||ANCOVA|||||||0.393
71827714|NCT03110458|143159362|SUPERIORITY|||||||0.5324|||||||ANCOVA|||||||0.5324
71886767|NCT00523991|143293839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74||||0.469||95.0|-3.01|6.49||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||6.49|-3.01|0.469
71712866|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|17.44||||0.001|TWO_SIDED|95.0|7.83|27.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.06|7.83|0.001
71712867|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|72.63|||<|0.001|TWO_SIDED|95.0|61.14|84.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.11|61.14|<0.001
71712868|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|11.7||||0.013|TWO_SIDED|95.0|3.47|19.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.93|3.47|0.013
71712869|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71712870|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|8.01||||0.041|TWO_SIDED|95.0|1.27|14.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.75|1.27|0.041
71712871|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71712872|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
71712873|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71712874|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
71712875|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|73.58|||<|0.001|TWO_SIDED|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.33|61.83|<0.001
71712876|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|6.79||||0.073|TWO_SIDED|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.36|0.23|0.073
71712877|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|74.71|||<|0.001|TWO_SIDED|95.0|63.14|86.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.27|63.14|<0.001
71712878|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|7.84||||0.035|TWO_SIDED|95.0|1.57|14.1||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.10|1.57|0.035
71886768|NCT00523991|143293840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.79||||0.079||95.0|-0.68|12.26||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||12.26|-0.68|0.079
71712879|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71712880|NCT01098747|142942114|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71712881|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|20.01||||0.004|TWO_SIDED|95.0|8.79|31.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.24|8.79|0.004
71712882|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|14.35||||0.003|TWO_SIDED|95.0|4.26|24.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.43|4.26|0.003
71712883|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|69.53|||<|0.001|TWO_SIDED|95.0|57.67|81.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.40|57.67|<0.001
71712884|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|23.45|||<|0.001|TWO_SIDED|95.0|13.16|33.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.75|13.16|<0.001
71827715|NCT01616654|143159392|SUPERIORITY||Percentage difference|13.115||||0.096|TWO_SIDED|95.0|-3.266|29.495|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||29.495|-3.266|0.096
71827716|NCT01616654|143159392|SUPERIORITY||Percentage difference|16.393||||0.04|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction||33.036|-0.249|0.040
71886769|NCT00523991|143293841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.051||95.0|-0.02|8.23||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||8.23|-0.02|0.051
71656303|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|1.95|6.05|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||6.05|1.95|
71656304|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|4.77|||||TWO_SIDED|95.0|2.69|8.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||8.45|2.69|
71656305|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|8.06|||||TWO_SIDED|95.0|3.36|19.35|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||19.35|3.36|
71712885|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|73.72|||<|0.001|TWO_SIDED|95.0|62.77|84.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.67|62.77|<0.001
71712886|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|10.14||||0.014|TWO_SIDED|95.0|3.21|17.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.08|3.21|0.014
71827717|NCT01616654|143159392|SUPERIORITY||Percentage difference|10.273||||0.184|TWO_SIDED|95.0|-5.923|26.47|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||26.470|-5.923|0.184
71827718|NCT01616654|143159392|SUPERIORITY||Percentage difference|16.393||||0.041|TWO_SIDED|95.0|-0.249|33.036|||Cochran-Mantel-Haenszel|||The 95% confidence interval on the difference between Vehicle and the specified treatment group success rates was based on normal approximation with continuity correction.||33.036|-0.249|0.041
71827719|NCT01616654|143159393|SUPERIORITY||Percentage difference|-6.74||||0.108|TWO_SIDED|95.0|-14.96|1.48|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||1.48|-14.96|0.108
71827720|NCT01616654|143159393|SUPERIORITY||Percentage difference|-7.88||||0.06|TWO_SIDED|95.0|-16.11|0.34|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with terms for treatment, stratum, and Baseline lesion count as covariate.||0.34|-16.11|0.060
71712887|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71712888|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|8.35||||0.028|TWO_SIDED|95.0|2.02|14.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.68|2.02|0.028
71712889|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71712890|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.81||||0.036|TWO_SIDED|95.0|1.54|14.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.08|1.54|0.036
71712891|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71712892|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71712893|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71712894|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71712895|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71712896|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71766544|NCT03602560|143034941|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71827721|NCT01616654|143159393|SUPERIORITY||Percentage difference|-8.11||||0.054|TWO_SIDED|95.0|-16.35|0.13|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||0.13|-16.35|0.054
71827722|NCT01616654|143159393|SUPERIORITY||Percentage difference|-12.97||||0.002|TWO_SIDED|95.0|-21.18|-4.76|||ANCOVA|||Analysis was performed using ANCOVA with terms for treatment, stratum, treatment stratum, and with Baseline lesion count as covariate.||-4.76|-21.18|0.002
71827723|NCT01616654|143159394|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|||||||0.067
71827724|NCT01616654|143159394|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||||||0.054
71827725|NCT01616654|143159394|SUPERIORITY|||||||0.038|||||||Cochran-Mantel-Haenszel|||||||0.038
71827726|NCT01616654|143159394|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||||||0.003
71712897|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71827727|NCT00286741|143159402|SUPERIORITY_OR_OTHER|||||||0.15|||||||Mixed Models Analysis|||||||0.15
71712898|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71712899|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71766545|NCT03602560|143034941|OTHER|The primary endpoint was analyzed using Cochran-Mantel-Haenszel (CMH) test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 2:350 U/L; pruritus NRS: \<4 and 2:4).|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71827728|NCT00286741|143159403|SUPERIORITY_OR_OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71827729|NCT02057692|143159405|SUPERIORITY||LS mean difference|-0.889|STANDARD_ERROR_OF_MEAN|0.3969||0.0321|TWO_SIDED|95.0|-1.698|0.081|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by analysis of covariance (ANCOVA) using a PROC MIXED procedure. Least-squares (LS) mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.081|-1.698|0.0321
71827730|NCT02057692|143159405|SUPERIORITY||LS mean difference|-0.906|STANDARD_ERROR_OF_MEAN|0.3503||0.0145|TWO_SIDED|95.0|-1.62|-0.192|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% CI for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||-0.192|-1.620|0.0145
71827731|NCT02057692|143159405|SUPERIORITY||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.4431||0.9298|TWO_SIDED|95.0|-0.942|0.863|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.||0.863|-0.942|0.9298
71827732|NCT02633358|143159410|SUPERIORITY|Therapeutic hypothermia need to have superiority in the survival rate after 90 days|Risk Ratio (RR)|0.58|||<|0.001|TWO_SIDED|95.0|0.41|0.82||P-value less than 0.05 means significant data|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.82|0.41|<0.001
71656306|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|16.14|||||TWO_SIDED|95.0|6.68|39.01|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||39.01|6.68|
71656307|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.14|||||TWO_SIDED|95.0|4.93|16.95|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||16.95|4.93|
71656308|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|13.58|||||TWO_SIDED|95.0|7.28|25.32|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||25.32|7.28|
71656309|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|9.24|||||TWO_SIDED|95.0|5.56|15.36|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||15.36|5.56|
71656310|NCT04168190|142830838|OTHER|Geometric mean concentration (GMC) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|12.5|||||TWO_SIDED|95.0|7.49|20.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||20.87|7.49|
71656311|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.67|1.47|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 3||1.47|0.67|
71656312|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.06|||||TWO_SIDED|95.0|0.72|1.57|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 3||1.57|0.72|
71656313|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.88||||||95.0|0.54|1.42|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 7F||1.42|0.54|
71656314|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.68|1.8|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 7F||1.80|0.68|
71656315|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.59|1.54|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 19A||1.54|0.59|
71656316|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.32|||||TWO_SIDED|95.0|0.81|2.15|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 19A||2.15|0.81|
71656317|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.65|||||TWO_SIDED|95.0|0.85|3.23|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 22F||3.23|0.85|
71827733|NCT02633358|143159411|SUPERIORITY|Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.|Risk Ratio (RR)|0.8||||0.04|TWO_SIDED|95.0|0.66|0.98||P value less than 0.05 means significant date|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group||0.98|0.66|0.04
71827734|NCT02633358|143159412|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
71766546|NCT03602560|143034942|OTHER|Two-sided p-value for each pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (ALP level: \<350 U/L and 350 U/L; pruritus NRS: \<4 and 4). Breslow-Day test was used to check the homogeneity of treatment effects across stratum.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71766547|NCT03602560|143034942|OTHER|Two-sided p-value for each pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both randomization stratification variables (ALP level: \< 350 U/L and \>= 350 U/L; pruritus NRS: \< 4 and \>= 4). Breslow-Day test is used to check the homogeneity of treatment effects across stratum.||||||0.0839|||||||Cochran-Mantel-Haenszel|||||||0.0839
71766548|NCT03602560|143034943|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-1.59||||0.0164|TWO_SIDED|95.0|-2.87|-0.3|||ANCOVA|||||-0.3|-2.87|0.0164
71766549|NCT03602560|143034943|OTHER|"Change from baseline is estimated by an analysis of covariance (ANCOVA) model with treatment group (including 3 levels:~Placebo, Initial Dose 5mg, and Initial Dose 10 mg) and randomization ALP stratification as factors, and baseline as a covariate.~The p-value for the interaction between treatment and stratum is 0.7595, hence the interaction is dropped from the model."|Risk Difference (RD)|-0.46||||0.4781|TWO_SIDED|95.0|-1.77|0.84|||ANCOVA|||||0.84|-1.77|0.4781
71766550|NCT01588470|143034962|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71766551|NCT01588470|143034964|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71827735|NCT02633358|143159413|SUPERIORITY||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
71712900|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71712901|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|72.61|||<|0.001|TWO_SIDED|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.17|61.05|<0.001
71766552|NCT03645434|143034965|SUPERIORITY||Mean Difference (Final Values)|0.202|||<|0.0001|TWO_SIDED|95.0|0.151|0.253|||Mixed Models Analysis|||||0.253|0.151|<0.0001
71766553|NCT03645434|143034970|SUPERIORITY||Mean Difference (Final Values)|0.098|||<|0.0001|TWO_SIDED|95.0|0.051|0.146|||Mixed Models Analysis|||Day 2||0.146|0.051|<0.0001
71766554|NCT03645434|143034970|SUPERIORITY||Mean Difference (Final Values)|0.195|||<|0.0001|TWO_SIDED|95.0|0.148|0.242|||Mixed Models Analysis|||Day 8||0.242|0.148|<0.0001
71766555|NCT03645434|143034971|SUPERIORITY||Mean Difference (Final Values)|0.306|||<|0.0001|TWO_SIDED|95.0|0.266|0.346|||Mixed Models Analysis|||Day 1||0.346|0.266|<0.0001
71766556|NCT03645434|143034971|SUPERIORITY||Mean Difference (Final Values)|0.374|||<|0.0001|TWO_SIDED|95.0|0.324|0.425|||Mixed Models Analysis|||Day 8||0.425|0.324|<0.0001
71766557|NCT03645434|143034971|SUPERIORITY||Mean Difference (Final Values)|0.388|||<|0.0001|TWO_SIDED|95.0|0.329|0.447|||Mixed Models Analysis|||Day 14||0.447|0.329|<0.0001
71766558|NCT03645434|143034972|SUPERIORITY||Mean Difference (Final Values)|-0.551||||0.001|TWO_SIDED|95.0|-0.876|-0.226|||Mixed Models Analysis|||Day 1 to Day 8||-0.226|-0.876|0.0010
71766559|NCT03645434|143034972|SUPERIORITY||Mean Difference (Final Values)|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.248|-0.486|||Mixed Models Analysis|||Day 9 to Day 14||-0.486|-1.248|<0.0001
71827736|NCT02633358|143159414|SUPERIORITY||||||<|0.05||||||P-value less then 0.05 is statistical significance.|t-test, 2 sided|||||||<0.05
71827737|NCT00864682|143159415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Kruskal-Wallis|||Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.||||<0.0001
71827738|NCT00864682|143159416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.008||95.0|||||Chi-squared|Fisher's exact test after chi-squared||||||<0.008
71827739|NCT00957658|143159418|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 6%|||||<|0.0001|||||||Asymptotic WALD test|||Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years||||<.0001
71827740|NCT00957658|143159421|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Improvement from preop to 2 year and preop to 5 year||||<.0001
71827741|NCT00957658|143159422|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year||||<.0001
71827742|NCT00957658|143159422|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Mental Score preop to 2 years||||<.0001
71827743|NCT00957658|143159422|SUPERIORITY_OR_OTHER|||||||0.0004|||||||t-test, 2 sided|||Compare SF-12 Mental Score preop to 5 years||||.0004
71827744|NCT00957658|143159423|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Compare LEAS score preop to 2 years and preop to 5 years||||<.0001
71827745|NCT00957658|143159426|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)||||<.0001
71827746|NCT00957658|143159427|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||Compare Wrist DXA T-score preop to 5 years||||.0002
71827747|NCT03621761|143159438|SUPERIORITY||Slope|1.774||||0.3451|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.3451
71712902|NCT01098747|142942115|SUPERIORITY_OR_OTHER||Difference in proportion|7.28||||0.047|TWO_SIDED|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.48|1.07|0.047
71766560|NCT03645434|143034972|SUPERIORITY||Mean Difference (Final Values)|-0.722|||<|0.0001|TWO_SIDED|95.0|-1.047|-0.397|||Mixed Models Analysis|||Day 1 to Day 14||-0.397|-1.047|<0.0001
71766561|NCT03645434|143034973|SUPERIORITY||Mean Difference (Final Values)|-1.571||||0.0022|TWO_SIDED|95.0|-2.563|-0.579|||Mixed Models Analysis|||Day 1 to Day 8||-0.579|-2.563|0.0022
71766562|NCT03645434|143034973|SUPERIORITY||Mean Difference (Final Values)|-2.386|||<|0.0001|TWO_SIDED|95.0|-3.541|-1.23|||Mixed Models Analysis|||Day 9 to Day 14||-1.230|-3.541|<0.0001
71766563|NCT03645434|143034973|SUPERIORITY||Mean Difference (Final Values)|-1.912||||0.0003|TWO_SIDED|95.0|-2.923|-0.901|||Mixed Models Analysis|||Day 1 to Day 14||-0.901|-2.923|0.0003
71766564|NCT03645434|143034984|SUPERIORITY||Mean Difference (Final Values)|-1.268|||<|0.0001|TWO_SIDED|95.0|-1.741|-0.794|||Mixed Models Analysis|||Day 1 to Day 8||-0.794|-1.741|<0.0001
71766565|NCT03645434|143034984|SUPERIORITY||Mean Difference (Final Values)|-1.302|||<|0.0001|TWO_SIDED|95.0|-1.804|-0.8|||Mixed Models Analysis|||Day 9 to Day 14||-0.800|-1.804|<0.0001
71766566|NCT00833664|143034985|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|88.1|109.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||109.5|88.1|
71827748|NCT03621761|143159438|SUPERIORITY||Slope|1.3094||||0.4834|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on total MFIS score, in linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline MFIS score. Output reflects models that were imputed for missing data.||||0.4834
71827749|NCT03621761|143159439|SUPERIORITY||Slope|0.4077||||0.257|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.2570
71827750|NCT03621761|143159439|SUPERIORITY||Slope|-0.2452||||0.5017|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue intensity NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue intensity score.||||0.5017
71712903|NCT01098747|142942116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
71712904|NCT01098747|142942116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||0.281|TWO_SIDED|95.0|0.79|2.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||2.22|0.79|0.281
71766567|NCT00833664|143034986|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|107.6||||||90.0|104.7|110.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||110.6|104.7|
71766568|NCT00833664|143034987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|92.7|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.0|92.7|
71766569|NCT00678743|143034989|SUPERIORITY|All statistical significance were completed at the 5% level, two-tailed. Comparability of baseline characteristics between those who did and did not opt to enter the extension study was assessed with the chi square test and analysis of variance.||||||0.0008||||||Threshold for statistical significance p\<0.05|ANOVA|||||||0.0008
71766570|NCT01330017|143034993|SUPERIORITY_OR_OTHER|||||||0.4912||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4912
71766571|NCT01330017|143034993|SUPERIORITY_OR_OTHER|||||||0.4519||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.4519
71766572|NCT01330017|143034993|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.2186
71766573|NCT01330017|143034993|SUPERIORITY_OR_OTHER|||||||0.5983||95.0||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA|||||||0.5983
71766574|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
71827751|NCT03621761|143159440|SUPERIORITY||Slope|0.095||||0.154|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.154
71827752|NCT03621761|143159440|SUPERIORITY||Slope|0.034||||0.61|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in EMA fatigue interference NRS score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline EMA fatigue interference score.||||0.610
71827753|NCT03621761|143159441|SUPERIORITY||Slope|0.00427||||0.4955|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of CBT monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.4955
71712905|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-23.93|||<|0.001|TWO_SIDED|95.0|-36.67|-11.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.20|-36.67|<0.001
71712906|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.483|TWO_SIDED|95.0|-4.12|1.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.70|-4.12|0.483
71712907|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-51.93|||<|0.001|TWO_SIDED|95.0|-65.63|-38.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.22|-65.63|<0.001
71712908|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-3.61||||0.174|TWO_SIDED|95.0|-7.97|0.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.75|-7.97|0.174
71712909|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-66.58|||<|0.001|TWO_SIDED|95.0|-79.8|-53.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.35|-79.80|<0.001
71766575|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||6.94|-3.53|
71766576|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.||4.72|-4.78|
71766577|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.78||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.78|-4.78|
71827754|NCT03621761|143159441|SUPERIORITY||Slope|-0.00948||||0.1333|TWO_SIDED||||||Regression, Linear|||Comparison of treatment effect of modafinil monotherapy vs. combination therapy (reference) on change in fatigability score, in complete case linear regression models adjusted for age, sex, anxiety, pain, activity level, study site, and baseline fatigability score.||||0.1333
71827755|NCT00208507|143159453|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This was a non-inferiority test of the Harris Hip Score means at 24+ months with a 5 point non-inferiority margin.|Mean Difference (Final Values)|0.61||||0.001|ONE_SIDED|95.0|-1.56||||ANCOVA|Preoperative Harris Hip score was included in the ANCOVA model as the only covariate.|||||-1.56|0.001
71827756|NCT00982033|143159457|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|||||||0.90
71827757|NCT01183780|143159458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0219|TWO_SIDED|95.0|0.73|0.976|||Log Rank|The analysis was performed on stratified data.|The estimation was performed on stratified data.|||0.976|0.730|0.0219
71827758|NCT01183780|143159459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.793||||0.0005|TWO_SIDED|95.0|0.697|0.903|||Log Rank|Analysis was performed on stratified data.|Analysis was performed on stratified data.|||0.903|0.697|0.0005
71827759|NCT01183780|143159460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6336|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6336
71766578|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
71766579|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.||4.72|-4.78|
71886770|NCT00523991|143293842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43||||0.075||95.0|-0.35|7.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||7.21|-0.35|0.075
71656318|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.01|||||TWO_SIDED|95.0|1.03|3.96|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 22F||3.96|1.03|
71656319|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.44|1.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 33F||1.67|0.44|
71656320|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|0.97|3.69|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 33F||3.69|0.97|
71656321|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.46|1.08|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 8||1.08|0.46|
71656322|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.58|1.38|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 8||1.38|0.58|
71656323|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.62|2.15|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 9N||2.15|0.62|
71656324|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.58|2.04|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 9N||2.04|0.58|
71656325|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.9|2.71|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 10A||2.71|0.90|
71656326|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.87|||||TWO_SIDED|95.0|1.08|3.23|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 10A||3.23|1.08|
71656327|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.53|1.49|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 11A||1.49|0.53|
71656328|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.66|1.87|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 11A||1.87|0.66|
71656329|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.89|3.27|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 12F||3.27|0.89|
71656330|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.24|4.62|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 12F||4.62|1.24|
71656331|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.97|||||TWO_SIDED|95.0|1.16|3.34|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 17F||3.34|1.16|
71656332|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.06|||||TWO_SIDED|95.0|1.21|3.51|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 17F||3.51|1.21|
71656333|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.77|1.91|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 20A||1.91|0.77|
71656334|NCT04168190|142830839|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|1.56|||||TWO_SIDED|95.0|0.99|2.45|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 20A||2.45|0.99|
71712910|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-3.75||||0.24|TWO_SIDED|95.0|-9.38|1.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.89|-9.38|0.240
71712911|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-61.36|||<|0.001|TWO_SIDED|95.0|-75.21|-47.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.50|-75.21|<0.001
71712912|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|1.52||||0.668|TWO_SIDED|95.0|-5.47|8.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.52|-5.47|0.668
71712913|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-60.31|||<|0.001|TWO_SIDED|95.0|-74.28|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-74.28|<0.001
71712914|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|1.1||||0.98|TWO_SIDED|95.0|-7.44|7.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.63|-7.44|0.980
71712915|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-59.28|||<|0.001|TWO_SIDED|95.0|-73.05|-45.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.50|-73.05|<0.001
71712916|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|1.56||||0.711|TWO_SIDED|95.0|-6.68|9.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.81|-6.68|0.711
71712917|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-56.84|||<|0.001|TWO_SIDED|95.0|-70.84|-42.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.85|-70.84|<0.001
71766580|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
71766581|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||TWO_SIDED|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||6.94|-3.53|
71766582|NCT01106092|143035009|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group \[Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3\] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.||4.72|-4.78|
71766583|NCT01473368|143035058|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
71766584|NCT01473368|143035062|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71766585|NCT00594425|143035119|SUPERIORITY_OR_OTHER||% success rate|5.53||||0.5288|TWO_SIDED|95.0|-7.97|19.04||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||19.04|-7.97|0.5288
71827760|NCT02613364|143159496|NON_INFERIORITY|Non-inferiority is established if the difference in mean change on the ISI between YOCAS©® and CBT-I is less than 1.15. Using ANCOVA to estimate differences in mean change between YOCAS©® and CBT-I, a correlation of 0.576 (from our prior study), and a sample of 168 subjects per group, we will have sufficient (80%) power to detect non-inferiority using a margin of 1.15 at p = 0.025.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|2.66|4.37||The p-value shown above is from the Least Squares Mean between YOCAS - CBT-I from the Mixed Model.|Mixed Models Analysis||The comparison is YOCAS - CBT-I|Constructed a 95% confidence interval on the mean change of ISI from baseline between the arms (YOCAS - CBT-I). If the lower bound of the interval is less than 1.5 then we conclude that YOCAS is non-inferior.||4.37|2.66|<.0001
71827761|NCT02613364|143159497|SUPERIORITY|Using ANCOVA to estimate differences in mean change between YOCAS and health education, a correlation of 0.576 (from our prior study), and a sample size of 168 evaluable subjects per group, we will have sufficient power to detect differences on the ISI of at least 1.3, 1.5 and 1.6 (all larger than our 1.15 non-inferiority margin) at 80%, 90%, and 95% power, respectively|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0009|TWO_SIDED|95.0|-2.23|-0.58||the comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.58|-2.23|0.0009
71766586|NCT00594425|143035119|SUPERIORITY_OR_OTHER||% success rate|3.95||||0.7539|TWO_SIDED|95.0|-8.79|16.69||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||16.69|-8.79|0.7539
71766587|NCT00594425|143035120|SUPERIORITY_OR_OTHER||Least squares mean|-2.64||||0.3236|TWO_SIDED|95.0|-7.91|2.63||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||2.63|-7.91|0.3236
71766588|NCT00594425|143035120|SUPERIORITY_OR_OTHER||Least squares mean|-1.19||||0.6657|TWO_SIDED|95.0|-6.64|4.26||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||4.26|-6.64|0.6657
71766589|NCT00594425|143035148|SUPERIORITY_OR_OTHER||%success rate|3.09||||0.7889|TWO_SIDED|95.0|-11.16|17.33||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||17.33|-11.16|0.7889
71766590|NCT00594425|143035148|SUPERIORITY_OR_OTHER||Percent success|5.48||||0.888|TWO_SIDED|95.0|-10.15|21.11||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||21.11|-10.15|0.8880
71766591|NCT00594425|143035149|SUPERIORITY_OR_OTHER||Least squares mean|-0.33||||0.9151|TWO_SIDED|95.0|-6.53|5.86||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.86|-6.53|0.9151
71827762|NCT02613364|143159498|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-0.98|0.04||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.04|-0.98|0.0700
71827763|NCT02613364|143159499|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|1.7|2.75||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the ISI Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||2.75|1.70|<.0001
71766592|NCT00594425|143035149|SUPERIORITY_OR_OTHER||Least squares mean|-1.18||||0.7233|TWO_SIDED|95.0|-7.81|5.45||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||5.45|-7.81|0.7233
71766593|NCT01122264|143035151|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66|||<|0.001|TWO_SIDED|97.3|0.51|0.85||P-value: Tadalafil Once a Day versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.85|0.51|<0.001
71766594|NCT01122264|143035151|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.49|||<|0.001|TWO_SIDED|97.3|0.37|0.65||P-value: Tadalafil On Demand versus Sildenafil Citrate On Demand treatment groups. Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||0.65|0.37|<0.001
71766595|NCT01122264|143035151|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.033|TWO_SIDED|95.0|1.02|1.71||P-value: Tadalafil On Demand versus Tadalafil Once a Day treatment groups using Cox's proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox|||||1.71|1.02|0.033
71712918|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|3.72||||0.445|TWO_SIDED|95.0|-5.94|13.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.38|-5.94|0.445
71712919|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|-52.79|||<|0.001|TWO_SIDED|95.0|-66.77|-38.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-38.81|-66.77|<0.001
71827764|NCT02613364|143159500|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|19.73|STANDARD_ERROR_OF_MEAN|7.03||0.0052|TWO_SIDED|95.0|5.91|33.54||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||33.54|5.91|0.0052
71827765|NCT02613364|143159501|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|15.94|STANDARD_ERROR_OF_MEAN|7.12||0.0258|TWO_SIDED|95.0|1.93|29.94||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis|||||29.94|1.93|0.0258
71656335|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.98|||||TWO_SIDED|95.0|5.9|33.1|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 6A||33.10|5.90|
71656336|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|14.42|||||TWO_SIDED|95.0|6.05|34.35|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 6A||34.35|6.05|
71656337|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.39||||||95.0|4.29|12.75|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15A||12.75|4.29|
71656338|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|9.4|||||TWO_SIDED|95.0|5.42|16.28|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15A||16.28|5.42|
71656339|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.13|||||TWO_SIDED|95.0|1.25|3.63|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 15C||3.63|1.25|
71656340|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.64|4.79|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 15C||4.79|1.64|
71656341|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|3.79|||||TWO_SIDED|95.0|1.88|7.67|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 16F||7.67|1.88|
71656342|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|5.87|||||TWO_SIDED|95.0|2.88|11.94|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 16F||11.94|2.88|
71656343|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|13.76|||||TWO_SIDED|95.0|5.68|33.32|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23A||33.32|5.68|
71656344|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.28|||||TWO_SIDED|95.0|7.91|47.0|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23A||47.00|7.91|
71656345|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|23.85|||||TWO_SIDED|95.0|8.64|65.82|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 23B||65.82|8.64|
71656346|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|39.39|||||TWO_SIDED|95.0|14.15|109.65|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 23B||109.65|14.15|
71656347|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|19.88|||||TWO_SIDED|95.0|9.03|43.74|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 24F||43.74|9.03|
71656348|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|31.07|||||TWO_SIDED|95.0|13.98|69.03|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 24F||69.03|13.98|
71656349|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|57.79|||||TWO_SIDED|95.0|25.15|132.78|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 31||132.78|25.15|
71656350|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|58.07|||||TWO_SIDED|95.0|25.1|134.33|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 31||134.33|25.10|
71656351|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|6.93|||||TWO_SIDED|95.0|4.45|10.8|||||Phase 1: V116 0.5 mL/Phase 1: Pneumovax™23|Serotype 35B||10.80|4.45|
71712920|NCT01098747|142942117|SUPERIORITY_OR_OTHER||Difference in proportion|6.05||||0.256|TWO_SIDED|95.0|-4.75|16.84||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.84|-4.75|0.256
71712921|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|6.34||||0.078|TWO_SIDED|95.0|1.34|11.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.34|1.34|0.078
71827766|NCT02613364|143159502|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.92|TWO_SIDED|95.0|-0.053|0.048||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|||0.048|-0.053|0.92
71827767|NCT02613364|143159503|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.07|TWO_SIDED|95.0|-0.004|0.098||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to the CBT-I control is a traditional null hypothesis of no difference with a two-sided alpha.||0.098|-0.004|0.07
71712922|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|2.74||||0.303|TWO_SIDED|95.0|-3.01|8.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.49|-3.01|0.303
71712923|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|27.24|||<|0.001|TWO_SIDED|95.0|18.14|36.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.34|18.14|<0.001
71712924|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|6.66||||0.217|TWO_SIDED|95.0|-4.31|17.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.63|-4.31|0.217
71712925|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|41.16|||<|0.001|TWO_SIDED|95.0|31.2|51.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.12|31.20|<0.001
71712926|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|8.86||||0.149|TWO_SIDED|95.0|-3.33|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.33|0.149
71712927|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|48.61|||<|0.001|TWO_SIDED|95.0|38.49|58.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||58.73|38.49|<0.001
71712928|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|4.55||||0.477|TWO_SIDED|95.0|-8.03|17.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.13|-8.03|0.477
71712929|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|52.81|||<|0.001|TWO_SIDED|95.0|42.63|62.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||62.99|42.63|<0.001
71766596|NCT02558829|143035170|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= MAC outcome positive and ITT outcome positive; C = MAC outcome negative and ITT positive|CI (Clopper Pearson): positive agreement|74.32|||||TWO_SIDED|95.0|62.84|83.78||||||The estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The performance of the MAC (cut-off point 2.8 ng/mL) was considered to be acceptable if the lower bound of the two-sided 95% CI (or lower bound of the one-sided 97.5% CI) was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.||83.78|62.84|
71766597|NCT02558829|143035170|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = MAC outcome negative and ITT outcome negative; B = MAC outcome positive and ITT outcome negative|CI (Clopper Pearson): negative agreement|93.94|||||TWO_SIDED|95.0|85.2|98.32||||||Please refer to Statistical Analysis 1.||98.32|85.20|
71766598|NCT02558829|143035171|OTHER|The secondary diagnostic accuracy measure was 'percent overall agreement'.|overall agreement|83.57|||||TWO_SIDED|95.0|76.38|89.29||||||This variable was analyzed using the same methodology described for the analyses for the primary efficacy variables. in the below, the results for Step 1 (peak GH level among all post baseline samples) are presented.||89.29|76.38|
71766599|NCT02558829|143035173|OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|6.38|||TWO_SIDED|||||||||"Pre/post dose comparison of ECGs was done for both GHSTs. During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.~Calculations were done from two time points: baseline and 60 min post-dose. Baseline is either the screening or pre-dose value."||||
71712930|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|-2.14||||0.739|TWO_SIDED|95.0|-14.77|10.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.50|-14.77|0.739
71712931|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71712932|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|-6.8||||0.28|TWO_SIDED|95.0|-19.24|5.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.65|-19.24|0.280
71712933|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71712934|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|-8.01||||0.202|TWO_SIDED|95.0|-20.44|4.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.41|-20.44|0.202
71712935|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71712936|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|-8.61||||0.17|TWO_SIDED|95.0|-21.02|3.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.80|-21.02|0.170
71766600|NCT02558829|143035173|OTHER|Please refer to Statistical Analysis 1 for this secondary outcome measure.|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|8.15|||TWO_SIDED|||||||||||||
71766601|NCT02558829|143035174|OTHER|Sensitivity is the probability that the test result is positive given the subject has the disease (for the purpose of this analysis, all group A subjects were assumed to have AGHD, but none of the group D subjects). Sensitivity (SS) was estimated by: SS = TP/(TP+FN). TP=True AGHD positive subject; FN=False AGHD negative subject.|CI (Clopper Pearson)|0.87|||||TWO_SIDED|95.0|0.72|0.96||||||Sensitivity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||0.96|0.72|
71712937|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71766602|NCT02558829|143035174|OTHER|"Specificity is the probability that the test result is negative given the subject does not have the disease.~Specificity (SP) was estimated by: SP = TN/(TN+FP). TN = True AGHD negative Subjects; FP = False AGHD positive subjects."|CI (Clopper Pearson)|0.96|||||TWO_SIDED|95.0|0.8|1.0||||||Specificity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.||1.00|0.80|
71766603|NCT02558829|143035175|OTHER|Positive percent agreement \[%\] = 100% x A/(A+C). A= test outcome positive for MAC core study part and positive for MAC repeatability extension; C = test outcome positive for MAC core study part and negative for MAC repeatability extension.|CI (Clopper Pearson): positive agreement|88.89|||||TWO_SIDED|95.0|65.29|98.62||||||Please refer to Statistical Analysis 1 for this outcome.||98.62|65.29|
71766604|NCT02558829|143035175|OTHER|Negative percent agreement \[%\] = 100% x D/(B+D). D = test outcome negative for MAC core study part and negative for MAC repeatability extension; B = test outcome negative for MAC core study part and positive for MAC repeatability extension|CI (Clopper Pearson): negative agreement|100.0|||||TWO_SIDED|95.0|79.41|100.0||||||Amendment no 1 had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study.||100.00|79.41|
71766605|NCT00097981|143035202|SUPERIORITY_OR_OTHER|||||||0.49|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.49
71766606|NCT00097981|143035203|SUPERIORITY_OR_OTHER|||||||0.42|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3||||||0.42
71766607|NCT00097981|143035204|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Log Rank|||||||0.42
71712938|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
71712939|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|48.53|||<|0.001|TWO_SIDED|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||60.77|36.29|<0.001
71712940|NCT01098747|142942118|SUPERIORITY_OR_OTHER||Difference in proportion|-9.23||||0.14|TWO_SIDED|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference \[Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)\] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.16|-21.62|0.140
71712941|NCT01098747|142942119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.83|0.98||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.98|0.83|<0.001
71712942|NCT01098747|142942119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.667|TWO_SIDED|95.0|-0.15|0.24||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.24|-0.15|0.667
71712943|NCT00189423|142942120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.019|TWO_SIDED|95.0|1.07|2.36|||Fisher Exact|||||2.36|1.07|0.019
71712944|NCT00189423|142942121|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 5%||||||0.0001|TWO_SIDED|95.0||||p value is for non-inferiority with a margin of 5% (exact binomial test)|Fisher Exact test, for non-inferiority|||||||0.0001
71712945|NCT00189423|142942121|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED|95.0|||||Fisher Exact|||||||0.681
71712946|NCT00189423|142942127|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED|95.0|||||Fisher Exact|||||||0.024
71712947|NCT03309202|142942251|OTHER||Mean Difference (Final Values)|130.47|||||TWO_SIDED|90.0|101.57|167.6|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.60|101.57|
71766608|NCT00097981|143035205|SUPERIORITY_OR_OTHER|||||||0.5162||95.0|||||Log Rank|||||||0.5162
71712948|NCT03309202|142942251|OTHER||Mean Difference (Final Values)|117.49|||||TWO_SIDED|90.0|91.46|150.93|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||150.93|91.46|
71712949|NCT03309202|142942251|OTHER||Mean Difference (Final Values)|130.55|||||TWO_SIDED|90.0|101.63|167.7|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||167.70|101.63|
71712950|NCT03309202|142942252|OTHER||Mean Difference (Final Values)|136.37|||||TWO_SIDED|90.0|94.63|196.53|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||196.53|94.63|
71712951|NCT03309202|142942252|OTHER||Mean Difference (Final Values)|124.23|||||TWO_SIDED|90.0|86.2|179.03|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||179.03|86.20|
71712952|NCT03309202|142942252|OTHER||Mean Difference (Final Values)|118.65|||||TWO_SIDED|90.0|82.33|170.99|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||170.99|82.33|
71766609|NCT00097981|143035206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.93|TWO_SIDED|95.0|0.529|1.797|||Log Rank|Stratified log-rank test||||1.797|0.529|0.93
71766610|NCT00538785|143035212|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.746|||||TWO_SIDED|95.0|0.344|1.586|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.586|0.344|
71766611|NCT00538785|143035213|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.495|||||TWO_SIDED|95.0|0.101|1.989|||Guess method|Exact conditional binomial method conditioning on the total number of cases with mid-probability adjustment||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF||1.989|0.101|
71766612|NCT01323855|143035233|NON_INFERIORITY_OR_EQUIVALENCE|Geometric Mean Ratio (GMR) is contained within the interval \[0.50, 2.00\]|GMR|1.19|||||TWO_SIDED|90.0|0.54|2.62|||||Severe CRI/Healthy|||2.62|0.54|
71766613|NCT01323855|143035234|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|1.3|||||TWO_SIDED|90.0|0.59|2.87|||||Moderate CRI/Healthy|||2.87|0.59|
71712953|NCT03309202|142942253|OTHER||Mean Difference (Final Values)|124.7309|||||TWO_SIDED|90.0|82.5275|188.5165|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||188.5165|82.5275|
71712954|NCT03309202|142942253|OTHER||Mean Difference (Final Values)|147.0778|||||TWO_SIDED|90.0|97.3132|222.2911|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||222.2911|97.3132|
71712955|NCT03309202|142942253|OTHER||Mean Difference (Final Values)|224.7373|||||TWO_SIDED|90.0|148.6962|339.6647|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||339.6647|148.6962|
71712956|NCT03309202|142942254|OTHER||Mean Difference (Final Values)|162.58|||||TWO_SIDED|90.0|103.12|256.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||256.32|103.12|
71712957|NCT03309202|142942254|OTHER||Mean Difference (Final Values)|172.74|||||TWO_SIDED|90.0|109.56|272.35|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||272.35|109.56|
71712958|NCT03309202|142942254|OTHER||Mean Difference (Final Values)|293.31|||||TWO_SIDED|90.0|186.04|462.44|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||462.44|186.04|
71712959|NCT03309202|142942255|OTHER||Mean Difference (Final Values)|169.84|||||TWO_SIDED|90.0|104.02|277.32|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||277.32|104.02|
71712960|NCT03309202|142942255|OTHER||Mean Difference (Final Values)|182.51|||||TWO_SIDED|90.0|111.78|298.02|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||298.02|111.78|
71712961|NCT03309202|142942255|OTHER||Mean Difference (Final Values)|266.29|||||TWO_SIDED|90.0|163.08|434.8|||ANOVA|The natural log transformed parameter was used.|Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.|||434.80|163.08|
71712962|NCT04734210|142942276|OTHER|Exploratory, descriptive analysis||||||0.2933||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.2933
71712963|NCT04734210|142942277|OTHER|Exploratory, descriptive analysis||||||0.1966||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.1966
71712964|NCT04734210|142942278|OTHER|Exploratory, descriptive analysis||||||0.0213||||||The difference in response rates between each of the SURF-200 formulations and vehicle was compared by Fisher's exact method.|Fisher Exact|The threshold for statistical significance is p=0.05.||Exploratory Phase 2 Study; approximately 120 subjects (approximately 40 subjects per each of the 3 treatment groups) were planned to be enrolled in the study. The sample size was based on medical judgment. No formal sample size calculation was performed, and the sample size was empirical. However, the sample size selected was considered sufficient to adequately characterize the general safety and efficacy profile of the study treatments.||||0.0213
71712965|NCT02138825|142942286|SUPERIORITY_OR_OTHER||LS mean difference|21.48||||0.2074|TWO_SIDED|95.0|-8.75|51.71|||ANCOVA|||The evaluation of primary efficacy endpoint will be based on change from baseline in 6MWD using analysis of covariance (ANCOVA) with baseline 6MWD, treatment arm and region as factors.||51.71|-8.75|0.2074
71712966|NCT02138825|142942287|SUPERIORITY_OR_OTHER|||||||0.3437|||||||Mantel Haenszel|||The difference in incidences in clinical worsening and mortality will be analyzed using Mantel-Haenszel weights, stratified by region.||||0.3437
71712967|NCT01690273|142942291|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71766614|NCT01323855|143035235|NON_INFERIORITY_OR_EQUIVALENCE|GMR is contained within the interval \[0.50, 2.00\]|GMR|2.63|||||TWO_SIDED|90.0|1.38|5.04|||||Mild CRI/Healthy|||5.04|1.38|
71712968|NCT01690273|142942291|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71712969|NCT01690273|142942291|SUPERIORITY_OR_OTHER|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71712970|NCT01690273|142942291|SUPERIORITY_OR_OTHER|||||||0.9913|||||||Mixed Models Analysis|||||||0.9913
71712971|NCT01690273|142942291|SUPERIORITY_OR_OTHER|||||||0.0427|||||||Mixed Models Analysis|||||||0.0427
71886771|NCT00523991|143293843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.306||95.0|-1.39|4.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and work productivity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||4.38|-1.39|0.306
71712972|NCT01690273|142942291|SUPERIORITY_OR_OTHER|||||||0.1856|||||||Mixed Models Analysis|||||||0.1856
71712973|NCT01690273|142942292|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71712974|NCT01690273|142942292|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
71712975|NCT01690273|142942292|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
71712976|NCT01690273|142942292|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71712977|NCT01690273|142942292|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
71712978|NCT01690273|142942292|SUPERIORITY_OR_OTHER|||||||0.876|||||||Mixed Models Analysis|||||||0.876
71712979|NCT01690273|142942293|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71712980|NCT01690273|142942293|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|||||||0.87
71712981|NCT01690273|142942293|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
71712982|NCT01690273|142942293|SUPERIORITY_OR_OTHER|||||||0.989|||||||Mixed Models Analysis|||||||0.989
71827768|NCT02613364|143159504|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.11||0.04|TWO_SIDED|95.0|0.09|4.44||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||4.44|0.09|0.04
71656352|NCT04168190|142830840|OTHER|Geometric mean titer (GMT) ratio and 95% confidence interval (CI) are estimated from a constrained longitudinal data analysis (cLDA) model.|GMT Ratio|7.82|||||TWO_SIDED|95.0|5.0|12.24|||||Phase 1: V116 1.0 mL/Phase 1: Pneumovax™23|Serotype 35B||12.24|5.00|
71712983|NCT01690273|142942293|SUPERIORITY_OR_OTHER|||||||0.022|||||||Mixed Models Analysis|||||||0.022
71712984|NCT01690273|142942293|SUPERIORITY_OR_OTHER|||||||0.119|||||||Mixed Models Analysis|||||||0.119
71712985|NCT01690273|142942294|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71712986|NCT01690273|142942294|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71712987|NCT01690273|142942294|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||0.94
71712988|NCT01690273|142942294|SUPERIORITY_OR_OTHER|||||||0.213|||||||Mixed Models Analysis|||||||0.213
71712989|NCT01690273|142942294|SUPERIORITY_OR_OTHER|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71712990|NCT01690273|142942294|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
71712991|NCT01690273|142942295|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71712992|NCT01690273|142942295|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71712993|NCT01690273|142942295|SUPERIORITY_OR_OTHER|||||||0.69|||||||Mixed Models Analysis|||||||0.69
71656353|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 3. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.30|0.90|<0.001
71656354|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.23|||<|0.001|TWO_SIDED|95.0|0.99|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 7F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|0.99|<0.001
71656355|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.24|||<|0.001|TWO_SIDED|95.0|1.02|1.52|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 19A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.52|1.02|<0.001
71656356|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.06|1.75|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 22F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.75|1.06|<0.001
71656357|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.69|1.06|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 33F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.06|0.69|<0.001
71656358|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.78|1.18|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 8. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.18|0.78|<0.001
71656359|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.3|||<|0.001|TWO_SIDED|95.0|1.04|1.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 9N. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.64|1.04|<0.001
71656360|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.44|2.32|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 10A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.32|1.44|<0.001
71712994|NCT01690273|142942295|SUPERIORITY_OR_OTHER|||||||0.874|||||||Mixed Models Analysis|||||||0.874
71712995|NCT01690273|142942295|SUPERIORITY_OR_OTHER|||||||0.057|||||||Mixed Models Analysis|||||||0.057
71712996|NCT01690273|142942295|SUPERIORITY_OR_OTHER|||||||0.526|||||||Mixed Models Analysis|||||||0.526
71712997|NCT01690273|142942296|SUPERIORITY_OR_OTHER|||||||0.853|||||||Mixed Models Analysis|||||||0.853
71712998|NCT01690273|142942296|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mixed Models Analysis|||||||0.016
71712999|NCT01690273|142942296|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
71713000|NCT01690273|142942296|SUPERIORITY_OR_OTHER|||||||0.889|||||||Mixed Models Analysis|||||||0.889
71713001|NCT01690273|142942296|SUPERIORITY_OR_OTHER|||||||0.098|||||||Mixed Models Analysis|||||||0.098
71713002|NCT01690273|142942296|SUPERIORITY_OR_OTHER|||||||0.645|||||||Mixed Models Analysis|||||||0.645
71713003|NCT01690273|142942297|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71713004|NCT01690273|142942297|SUPERIORITY_OR_OTHER|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71713005|NCT01690273|142942297|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
71713006|NCT01690273|142942297|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713007|NCT01690273|142942297|SUPERIORITY_OR_OTHER|||||||0.338|||||||Mixed Models Analysis|||||||0.338
71713008|NCT01690273|142942297|SUPERIORITY_OR_OTHER|||||||0.476|||||||Mixed Models Analysis|||||||0.476
71713009|NCT01690273|142942298|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
71713010|NCT01690273|142942298|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71713011|NCT01690273|142942298|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713012|NCT01690273|142942298|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713013|NCT01690273|142942298|SUPERIORITY_OR_OTHER|||||||0.995|||||||Mixed Models Analysis|||||||0.995
71713014|NCT01690273|142942298|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|||||||0.985
71713015|NCT01690273|142942299|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.9
71713016|NCT01690273|142942299|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.7
71713017|NCT01690273|142942299|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71713018|NCT01690273|142942299|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71713019|NCT01690273|142942299|SUPERIORITY_OR_OTHER|||||||0.9|||||||Mixed Models Analysis|||||||0.900
71713020|NCT01690273|142942299|SUPERIORITY_OR_OTHER|||||||0.739|||||||Mixed Models Analysis|||||||0.739
71713021|NCT01690273|142942300|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713022|NCT01690273|142942300|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713023|NCT01690273|142942300|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|||||||0.37
71713024|NCT01690273|142942300|SUPERIORITY_OR_OTHER|||||||0.618|||||||Mixed Models Analysis|||||||0.618
71713025|NCT01690273|142942300|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713026|NCT01690273|142942300|SUPERIORITY_OR_OTHER|||||||0.689|||||||Mixed Models Analysis|||||||0.689
71713027|NCT01690273|142942301|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||0.8
71713028|NCT01690273|142942301|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
71713029|NCT01690273|142942301|SUPERIORITY_OR_OTHER|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71713030|NCT01690273|142942301|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71713031|NCT01690273|142942301|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|||||||0.929
71713032|NCT01690273|142942301|SUPERIORITY_OR_OTHER|||||||0.98|||||||Mixed Models Analysis|||||||0.980
71713033|NCT01690273|142942302|SUPERIORITY_OR_OTHER|||||||1|||||||Mixed Models Analysis|||||||1
71713034|NCT01690273|142942302|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
71713035|NCT01690273|142942302|SUPERIORITY_OR_OTHER|||||||0.35|||||||Mixed Models Analysis|||||||0.350
71713036|NCT01690273|142942302|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
71713037|NCT01690273|142942302|SUPERIORITY_OR_OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.970
71713038|NCT01690273|142942302|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71713039|NCT01690273|142942303|SUPERIORITY_OR_OTHER|||||||0.997|||||||Mixed Models Analysis|||||||0.997
71713040|NCT01690273|142942303|SUPERIORITY_OR_OTHER|||||||0|||||||Mixed Models Analysis|||||||0.000
71713041|NCT01690273|142942303|SUPERIORITY_OR_OTHER|||||||0.503|||||||Mixed Models Analysis|||||||0.503
71713042|NCT01690273|142942303|SUPERIORITY_OR_OTHER|||||||0.814|||||||Mixed Models Analysis|||||||0.814
71713043|NCT01690273|142942303|SUPERIORITY_OR_OTHER|||||||0.643|||||||Mixed Models Analysis|||||||0.643
71713044|NCT01690273|142942303|SUPERIORITY_OR_OTHER|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71713045|NCT01690273|142942304|SUPERIORITY_OR_OTHER|||||||0.787|||||||Mixed Models Analysis|||||||0.787
71713046|NCT01690273|142942304|SUPERIORITY_OR_OTHER|||||||0.408|||||||Mixed Models Analysis|||||||0.408
71713047|NCT01690273|142942304|SUPERIORITY_OR_OTHER|||||||0.157|||||||Mixed Models Analysis|||||||0.157
71713048|NCT01690273|142942304|SUPERIORITY_OR_OTHER|||||||0.835|||||||Mixed Models Analysis|||||||0.835
71713049|NCT01690273|142942304|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||||||0.256
71713050|NCT01690273|142942304|SUPERIORITY_OR_OTHER|||||||0.935|||||||Mixed Models Analysis|||||||0.935
71713051|NCT01690273|142942305|SUPERIORITY_OR_OTHER|||||||0.978|||||||Mixed Models Analysis|||||||0.978
71713052|NCT01690273|142942305|SUPERIORITY_OR_OTHER|||||||0.169|||||||Mixed Models Analysis|||||||0.169
71713053|NCT01690273|142942305|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71713054|NCT01690273|142942305|SUPERIORITY_OR_OTHER|||||||0.993|||||||Mixed Models Analysis|||||||0.993
71713055|NCT01690273|142942305|SUPERIORITY_OR_OTHER|||||||0.105|||||||Mixed Models Analysis|||||||0.105
71713056|NCT01690273|142942305|SUPERIORITY_OR_OTHER|||||||0.335|||||||Mixed Models Analysis|||||||0.335
71713057|NCT00895921|142942341|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.1139||0.042|TWO_SIDED|95.0|0.00943|0.47605||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||.47605|.00943|0.042
71713058|NCT00895921|142942342|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.253|STANDARD_ERROR_OF_MEAN|0.224||0.269|TWO_SIDED|95.0|-0.208|0.714||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||0.714|-0.208|0.269
71713059|NCT00895921|142942343|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.149||0.012|TWO_SIDED|95.0|0.095|0.705|||Chi-squared, Corrected|||Comparison of akathisia rates between the two arms.||.705|.095|0.012
71713060|NCT00583219|142942357|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline at one month||||0.004
71713061|NCT00583219|142942357|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.81
71766615|NCT02683746|143035285|NON_INFERIORITY|The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.|Mean Difference (Net)|0.06||||0.0002|TWO_SIDED|95.0|-0.13|0.24||P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model|||||0.24|-0.13|0.0002
71766616|NCT02683746|143035293|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14||||||||0.14|-0.83|
71766617|NCT02683746|143035294|OTHER||Mean Difference (Net)|0.03|||<|0.0001|TWO_SIDED|95.0|-0.07|0.13||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.13|-0.07|<0.0001
71766618|NCT02683746|143035294|OTHER||Mean Difference (Net)|0.07|||<|0.0001|TWO_SIDED|95.0|-0.07|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.20|-0.07|<0.0001
71766619|NCT02683746|143035294|OTHER||Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.08|0.24||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.24|-0.08|<0.0001
71713062|NCT00583219|142942358|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.21
71713063|NCT00583219|142942358|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.43
71713064|NCT00583219|142942360|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.005
71713065|NCT00583219|142942361|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.22
71713066|NCT00583219|142942362|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
71713067|NCT00583219|142942362|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.14
71713068|NCT00583219|142942363|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.24
71713069|NCT00583219|142942363|SUPERIORITY_OR_OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.033
71713070|NCT00583219|142942364|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Exact binomial sign test|||P value change from baseline to 1 month||||>0.99
71713071|NCT00583219|142942364|SUPERIORITY_OR_OTHER|||||||0.25|||||||exact binomial sign test|||P value change from baseline to 3 months||||0.25
71713072|NCT00583219|142942366|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||<0.001
71713073|NCT00583219|142942367|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline||||0.004
71713074|NCT00583219|142942368|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month||||0.003
71713075|NCT00583219|142942368|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months.||||0.001
71713076|NCT00583219|142942369|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month||||0.001
71766620|NCT02683746|143035294|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.20|-0.16|<0.0001
71713077|NCT00583219|142942369|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||<0.001
71713078|NCT00583219|142942370|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month.||||0.007
71713079|NCT00583219|142942370|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months||||0.002
71713080|NCT04752566|142942383|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.8938|TWO_SIDED|95.0|0.45|1.97||Log Rank Test stratified by randomization strata.|Log Rank||Cox proportional hazard model stratified by randomization strata, with treatment group as the fixed effect. Firth's adjustment was applied if no event was observed in a treatment group.|||1.97|0.45|0.8938
71713081|NCT04752566|142942384|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8987|TWO_SIDED|95.0|0.27|3.17|||Regression, Logistic|||Week 8||3.17|0.27|0.8987
71713082|NCT04752566|142942384|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4083|TWO_SIDED|95.0|0.18|2.02|||Regression, Logistic|||Week 24||2.02|0.18|0.4083
71713083|NCT04752566|142942385|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6739|TWO_SIDED|95.0|0.24|2.54|||Regression, Logistic|||||2.54|0.24|0.6739
71713084|NCT01728246|142942393|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71713085|NCT01728246|142942394|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71713086|NCT01728246|142942396|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71713087|NCT01983111|142942399|NON_INFERIORITY_OR_EQUIVALENCE|In the PP set, for a non-inferiority test of the reduction in the pain intensity score from Visit 1 (Baseline) to Week 6 of treatment, the lower limit of the 97.5% onesided confidence interval was compared to a clinical non-inferiority margin, -1.5.|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|1.79||0.2658|TWO_SIDED|97.5|-6.0|3.0|||t-test, 2 sided|||In the Per protocol set||3|-6|0.2658
71827769|NCT02613364|143159505|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.12||0.49|TWO_SIDED|95.0|-2.97|1.43||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||1.43|-2.97|0.49
71656361|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.27|1.86|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 11A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||1.86|1.27|<0.001
71656362|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.75|3.04|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 12F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||3.04|1.75|<0.001
71656363|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.82|||<|0.001|TWO_SIDED|95.0|1.49|2.22|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 17F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.22|1.49|<0.001
71656364|NCT04168190|142830843|NON_INFERIORITY|Non-inferiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>0.5 (1-sided p-value \<0.025).|GMC Ratio|2.27|||<|0.001|TWO_SIDED|95.0|1.81|2.83|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 20A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||2.83|1.81|<0.001
71656365|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.77|||<|0.001|TWO_SIDED|95.0|2.95|4.84|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 6A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.84|2.95|<0.001
71656366|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.68|||<|0.001|TWO_SIDED|95.0|6.12|9.64|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||9.64|6.12|<0.001
71656367|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|3.29|||<|0.001|TWO_SIDED|95.0|2.6|4.17|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 15C. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||4.17|2.60|<0.001
71656368|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|8.65|||<|0.001|TWO_SIDED|95.0|7.19|10.41|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 16F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||10.41|7.19|<0.001
71656369|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|7.83|||<|0.001|TWO_SIDED|95.0|6.2|9.9|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23A. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model||9.90|6.20|<0.001
71656370|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|5.61|||<|0.001|TWO_SIDED|95.0|4.53|6.94|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 23B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||6.94|4.53|<0.001
71656371|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|23.99|||<|0.001|TWO_SIDED|95.0|19.35|29.74|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 24F. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||29.74|19.35|<0.001
71656372|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|10.13|||<|0.001|TWO_SIDED|95.0|8.32|12.33|||P-value was estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 31. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||12.33|8.32|<0.001
71656373|NCT04168190|142830844|SUPERIORITY|Superiority can be concluded if the lower bound of the 95% CI for the estimated GMC ratio (V116/PPSV23) is \>1.0 (1-sided p-value \<0.025).|GMC Ratio|18.29|||<|0.001|TWO_SIDED|95.0|15.59|21.45|||P-value is estimated from a cLDA model.||Phase 2: V116/Phase 2: Pneumovax™23|Serotype 35B. Geometric mean concentration (GMC) ratio, 95% confidence interval (CI), and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||21.45|15.59|<0.001
71656374|NCT01144364|142830869|SUPERIORITY_OR_OTHER|||||||0.254|||||||Log Rank|||Difference between treatment arms||||0.254
71656375|NCT01144364|142830871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.105|TWO_SIDED|95.0|0.31|1.12||Overall DFS|Cox proportional-hazards|Adjusted for randomization stratum and the known prognostic factors.||||1.12|0.31|0.105
71766621|NCT02683746|143035294|OTHER||Mean Difference (Net)|0.02|||<|0.0001|TWO_SIDED|95.0|-0.15|0.19||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.19|-0.15|<0.0001
71766622|NCT02683746|143035294|OTHER||Mean Difference (Net)|0.01|||<|0.0001|TWO_SIDED|95.0|-0.17|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.20|-0.17|<0.0001
71766623|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.15|0.65|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.|||0.65|-0.15|
71766624|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.2|0.69|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.|||0.69|-0.20|
71766625|NCT02683746|143035295|OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.42|0.4|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.|||0.40|-0.42|
71766626|NCT02683746|143035295|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.42|0.36|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.|||0.36|-0.42|
71766627|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.19|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.|||0.57|-0.19|
71766628|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.26|0.55|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.|||0.55|-0.26|
71766629|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-0.16|0.71|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.|||0.71|-0.16|
71766630|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.19|||||TWO_SIDED|95.0|-0.22|0.6|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.|||0.60|-0.22|
71766631|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.47|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.|||0.47|-0.41|
71766632|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.28|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.|||0.57|-0.28|
71766633|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.34|0.56|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.|||0.56|-0.34|
71766634|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.41|0.46|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.|||0.46|-0.41|
71766635|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.47|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.|||0.57|-0.47|
71766636|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.41|0.54|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.|||0.54|-0.41|
71766637|NCT02683746|143035295|OTHER||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.47|0.53|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.|||0.53|-0.47|
71766638|NCT02683746|143035295|OTHER||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.83|0.14|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.|||0.14|-0.83|
71766639|NCT04987944|143035297|OTHER||Least square mean difference|-9.8|||||TWO_SIDED|95.0|-24.5|5.0||||||||5.0|-24.5|
71766640|NCT04987944|143035298|OTHER||Least square mean difference|-3.9|||||TWO_SIDED|95.0|-19.4|11.5||||||||11.5|-19.4|
71766641|NCT04987944|143035299|OTHER||Least square mean difference|0.423|||||TWO_SIDED|95.0|-0.125|0.972||||||||0.972|-0.125|
71766642|NCT00345332|143035302|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
71766643|NCT00345332|143035303|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
71766644|NCT04121078|143035304|EQUIVALENCE|Point estimate and its 90% confidence interval (CI) were calculated for Treatment B to Treatment A ratio of geometric means for Cmax based on the mixed-effect model of log-transformed Cmax with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for Cmax. No adjustments were made for multiplicity.|Geometric Mean Ratio|6.24|||||TWO_SIDED|90.0|4.62|8.42||||||||8.42|4.62|
71886772|NCT00523991|143293844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.363||95.0|-7.39|2.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||2.73|-7.39|0.363
71656376|NCT01144364|142830872|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
71656377|NCT01144364|142830873|SUPERIORITY_OR_OTHER|||||||0.751|||||||Log Rank|||||||0.751
71656378|NCT01144364|142830875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.079|TWO_SIDED|95.0|0.38|1.05|||Cox proportional-hazards|||Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.||1.05|0.38|0.079
71656379|NCT01144364|142830878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.103|TWO_SIDED|95.0|0.4|1.09||Univariate analysis|Regression, Cox|Cox model stratified for the stratification groups.||||1.09|0.40|0.103
71656380|NCT01144364|142830878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.071|TWO_SIDED|95.0|0.37|1.04||Multivariate analysis|Regression, Cox|Adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, FL International prognostic index (FLIPI) score.||||1.04|0.37|0.071
71656381|NCT01144364|142830879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.084|TWO_SIDED|95.0|0.39|1.06||Univariate analysis|Fine and Gray model|Fine and Gray model stratified for the stratification groups.||||1.06|0.39|0.084
71713088|NCT00619866|142942431|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.25||0.2311|TWO_SIDED|95.0|-0.81|0.2|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.20|-0.81|0.2311
71713089|NCT00619866|142942431|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.25||0.1521|TWO_SIDED|95.0|-0.86|0.14|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.14|-0.86|0.1521
71713090|NCT00619866|142942432|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2041|TWO_SIDED|95.0|-0.77|0.17|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.17|-0.77|0.2041
71713091|NCT00619866|142942432|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.24||0.3375|TWO_SIDED|95.0|-0.69|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-0.69|0.3375
71713092|NCT00619866|142942432|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.0354|TWO_SIDED|95.0|-1.01|-0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.04|-1.01|0.0354
71713093|NCT00619866|142942432|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3618|TWO_SIDED|95.0|-0.71|0.26|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.26|-0.71|0.3618
71766645|NCT04121078|143035305|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUC∞ based on the mixed-effect model of log-transformed AUC∞ with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUC∞. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.16|||||TWO_SIDED|90.0|4.25|6.25||||||||6.25|4.25|
71766646|NCT04121078|143035306|EQUIVALENCE|Point estimate and its 90% CI were calculated for Treatment B to Treatment A ratio of geometric means for AUClast based on the mixed-effect model of log-transformed AUClast with sequence, treatment, and period as fixed effects, and participant nested within sequence as a random effect. Bioequivalence was concluded if the 90% CI for the ratio of geometric means is entirely contained within 80% to 125% for AUClast. No adjustments were made for multiplicity.|Geometric Mean Ratio|5.21|||||TWO_SIDED|90.0|4.29|6.32||||||||6.32|4.29|
71766647|NCT02700334|143035379|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71766648|NCT02700334|143035380|OTHER|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
71766649|NCT02700334|143035381|OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
71766650|NCT02700334|143035382|OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
71766651|NCT02700334|143035383|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71766652|NCT02700334|143035384|OTHER|||||||0.331|||||||Wilcoxon (Mann-Whitney)|||||||0.331
71713094|NCT00619866|142942433|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.46||0.799|TWO_SIDED|95.0|-1.01|0.78|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.78|-1.01|0.7990
71766653|NCT02700334|143035385|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71766654|NCT02700334|143035386|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71766655|NCT02700334|143035387|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
71766656|NCT02700334|143035388|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71766657|NCT02700334|143035389|OTHER|||||||0.721|||||||Wilcoxon (Mann-Whitney)|||||||0.721
71766658|NCT02700334|143035390|OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
71766659|NCT02700334|143035391|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
71766660|NCT02700334|143035392|OTHER|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
71766661|NCT02700334|143035393|OTHER|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71766662|NCT02700334|143035394|OTHER|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
71766663|NCT02700334|143035395|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
71766664|NCT01054183|143035400|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.57||95.0|||||z test, two-sided|||Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groups||||0.57
71766665|NCT01054183|143035401|NON_INFERIORITY_OR_EQUIVALENCE|powered for 62 patients||||||0.002||95.0|||||z test, two-sided|||Null hypothesis: overall successful intubation rate is the same for both groups.||||0.002
71766666|NCT02775240|143035402|OTHER||Ratio of geometric means|1.248|||||TWO_SIDED|90.0|1.13|1.378|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Digoxin||1.378|1.130|
71766667|NCT02775240|143035403|OTHER||Ratio of geometric means|0.944|||||TWO_SIDED|90.0|0.778|1.144|||Linear mixed effects model|||Comparison of Treatment B over Treatment A for Cmax of Dextromethorphan||1.144|0.778|
71766668|NCT02775240|143035404|OTHER||Ratio of geometric means|0.943|||||TWO_SIDED|90.0|0.883|1.007|||Linear mixed effects model||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Dextrorphan||1.007|0.883|
71766669|NCT02775240|143035410|OTHER||Ratio of geometric means|1.206|||||TWO_SIDED|90.0|1.099|1.324|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Digoxin||1.324|1.099|
71766670|NCT02775240|143035412|OTHER||Ratio of geometric means|0.971|||||TWO_SIDED|90.0|0.943|0.999|||Linear mixed effects model||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Dextrorphan||0.999|0.943|
71766671|NCT02775240|143035413|OTHER||Ratio of geometric means|1.179|||||TWO_SIDED|90.0|1.08|1.287|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Digoxin||1.287|1.080|
71766672|NCT02775240|143035414|OTHER||Ratio of geometric means|0.882|||||TWO_SIDED|90.0|0.696|1.118|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast of Dextromethorphan||1.118|0.696|
71766673|NCT02775240|143035415|OTHER||Ratio of geometric means|0.973|||||TWO_SIDED|90.0|0.949|0.998|||Linear mixed effects model||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Dextrorphan||0.998|0.949|
71766674|NCT02775240|143035416|OTHER||Ratio of geometric means|0.905|||||TWO_SIDED|90.0|0.721|1.138|||Linear mixed effects model||Log-transformed AUClast ratio values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Dextromethorphan/Dextrorphan (Parent/Metabolite) AUClast ratio||1.138|0.721|
71766675|NCT00796991|143035439|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.794|1.168|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log(Cmax) using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1)||1.168|0.794|
71827770|NCT02613364|143159506|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.43|TWO_SIDED|95.0|-0.13|0.05||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||0.05|-0.13|0.43
71827771|NCT02613364|143159507|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7|TWO_SIDED|95.0|-0.07|0.11||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||0.11|-0.07|0.70
71766676|NCT00796991|143035439|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.848|1.243|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on dacarbazine Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.243|0.848|
71766677|NCT00796991|143035439|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.058|||||TWO_SIDED|90.0|0.974|1.15|||Mixed Models Analysis|study day was used as a fixed effect||Estimated effect of ipilimumab on AIC Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.150|0.974|
71827772|NCT02613364|143159508|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.55||0.0041|TWO_SIDED|95.0|-2.65|-0.5||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.50|-2.65|0.0041
71656382|NCT01144364|142830879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.052|TWO_SIDED|95.0|0.38|1.0|||Fine and Gray model|Fine and Gray model adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, and FLIPI score||||1.00|0.38|0.052
71766678|NCT00796991|143035439|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934||||||90.0|0.768|1.136|||linear model|treatment arm as a fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
71827773|NCT02613364|143159509|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|1.61|3.81||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||3.81|1.61|<.0001
71886773|NCT00523991|143293846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.668||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and logarithm of baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.02|-0.03|0.668
71656383|NCT01635062|142830880|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.3||||0.69|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower plasma renin activity (PRA), when sodium restricted, when compared to placebo.||||0.69
71656384|NCT01635062|142830881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.8||||0.89|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would raise renal plasma flow, when sodium loaded, when compared to placebo.||||0.89
71656385|NCT01635062|142830882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0||||0.8|TWO_SIDED||||||ANOVA|||The hypothesis was that calcitriol therapy would lower urine protein, when sodium loaded, when compared to placebo.||||0.80
71656386|NCT01301508|142830887|SUPERIORITY_OR_OTHER|||||||0.008||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.|Two-sided sign test|||||||0.008
71656387|NCT01301508|142830887|SUPERIORITY_OR_OTHER|||||||0.017||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.|Two-sided sign test|||||||0.017
71656388|NCT03123861|142830926|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71656389|NCT03123861|142830927|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71656390|NCT03123861|142830928|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71656391|NCT03123861|142830929|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71656392|NCT01383421|142830934|SUPERIORITY||||||<|0.001||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||< 0.001
71656393|NCT01383421|142830936|SUPERIORITY|||||||0.058||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.058
71656394|NCT01383421|142830938|SUPERIORITY|||||||0.003||||||Statistical significance was set at P = 0.05.|Chi-squared|||||||0.003
71656395|NCT01383421|142830940|SUPERIORITY||LS Mean Difference|-0.203|STANDARD_ERROR_OF_MEAN|0.092||0.027|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.027
71656396|NCT01383421|142830940|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.094||0.006|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.006
71656397|NCT01383421|142830940|SUPERIORITY||LS Mean Difference|-0.233|STANDARD_ERROR_OF_MEAN|0.098||0.018|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.018
71656398|NCT01383421|142830941|SUPERIORITY||LS Mean Difference|-1.686|STANDARD_ERROR_OF_MEAN|0.893||0.059|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.059
71656399|NCT01383421|142830941|SUPERIORITY||LS Mean Difference|-2.697|STANDARD_ERROR_OF_MEAN|0.903||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.003
71656400|NCT01383421|142830941|SUPERIORITY||LS Mean Difference|-2.447|STANDARD_ERROR_OF_MEAN|0.945||0.01|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.010
71656401|NCT01383421|142830942|SUPERIORITY||LS Mean Difference|-1.791|STANDARD_ERROR_OF_MEAN|0.788||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.023
71656402|NCT01383421|142830942|SUPERIORITY||LS Mean Difference|-2.549|STANDARD_ERROR_OF_MEAN|0.818||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.002
71656403|NCT01383421|142830942|SUPERIORITY||LS Mean Difference|-2.734|STANDARD_ERROR_OF_MEAN|0.872||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.002
71656404|NCT01383421|142830946|SUPERIORITY||LS Mean Difference|1.333|STANDARD_ERROR_OF_MEAN|2.725||0.625|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.625
71656405|NCT01383421|142830946|SUPERIORITY||LS Mean Difference|-0.824|STANDARD_ERROR_OF_MEAN|2.441||0.736|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.736
71656406|NCT01383421|142830946|SUPERIORITY||LS Mean Difference|1.207|STANDARD_ERROR_OF_MEAN|3.126||0.7|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.700
71766679|NCT00796991|143035439|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.798|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.798|
71766680|NCT00796991|143035443|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.068|||||TWO_SIDED|90.0|0.954|1.196|||Mixed Models Analysis|A general linear mixed model was applied to paclitaxel log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on paclitaxel AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1).||1.196|0.954|
71766681|NCT00796991|143035443|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.912|||||TWO_SIDED|90.0|0.757|1.099|||Mixed Models Analysis|A general linear mixed model was applied to dacarbazine log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on dacarbazine AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.099|0.757|
71766682|NCT00796991|143035443|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.891|1.056|||Mixed Models Analysis|A general linear mixed model was applied to active metabolite AIC log\[AUC(INF)\] using study day as a fixed effect.||Estimated effect of ipilimumab on AUC(INF) for AIC. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).||1.056|0.891|
71766683|NCT00796991|143035443|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.934|||||TWO_SIDED|90.0|0.768|1.136|||linear model|treatment arm as fixed effect||Estimated effect of paclitaxel/carboplatin on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.||1.136|0.768|
71766684|NCT00796991|143035443|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.982|||||TWO_SIDED|90.0|0.7981|1.208|||linear model|treatment arm as a fixed effect||Estimated effect of dacarbazine on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.||1.208|0.7981|
71827774|NCT02613364|143159510|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.62||0.0108|TWO_SIDED|95.0|-2.78|-0.36||The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - Health Education) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - Health Education) generated from the Mixed Model.|The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.||-0.36|-2.78|0.0108
71827775|NCT02613364|143159511|EQUIVALENCE|The null hypothesis is that the mean change in the outcome measure between the two arms is zero.|Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|1.54|4.02||The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha. The p-value shown is from the Least Squares Mean (YOCAS - CBT-I) generated from the Mixed Model.|Mixed Models Analysis||The comparison is from the Least Squares Mean difference (YOCAS - CBT-I) generated from the Mixed Model.|The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.||4.02|1.54|<.0001
71766685|NCT00796991|143035449|SUPERIORITY_OR_OTHER|||||||0.027||||||p-value was not corrected for multiple testing. F-statistic = 1.86.|conditional F test|15 degrees freedom (DF) in numerator and 335 DF in denominator.||null hypothesis of no mean ALC changes over time in any treatment group. Conditional F-tests were used to test for mean ALC changes over time in each treatment arm and the difference between treatment arms in the pattern of change in ALC over time.||||0.027
71766686|NCT00796991|143035449|SUPERIORITY_OR_OTHER|||||||0.5||||||P-values were not corrected for multiple testing. F Statistic =0.94|Omnibus conditional F-test|10 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in all treatment groups. Test of overall time-by-treatment interaction used an omnibus conditional F-test.||||0.5
71766687|NCT00796991|143035449|SUPERIORITY_OR_OTHER|||||||0.37||||||P-values were not corrected for multiple testing. F Statistic =1.08|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.37
71766688|NCT00796991|143035449|SUPERIORITY_OR_OTHER|||||||0.85||||||P-values were not corrected for multiple testing. F Statistic =0.39|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.85
71766689|NCT00796991|143035449|SUPERIORITY_OR_OTHER|||||||0.22||||||P-values were not corrected for multiple testing. F Statistic = 1.41|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.||||0.22
71766690|NCT02184624|143035471|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766691|NCT02184624|143035471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
71713095|NCT00619866|142942433|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.46||0.5042|TWO_SIDED|95.0|-1.21|0.59|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.59|-1.21|0.5042
71713096|NCT00619866|142942433|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.48||0.1459|TWO_SIDED|95.0|-1.63|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.24|-1.63|0.1459
71713097|NCT00619866|142942433|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.48||0.0163|TWO_SIDED|95.0|-2.1|-0.21|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.21|-2.10|0.0163
71713098|NCT00619866|142942433|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0207|TWO_SIDED|95.0|-2.13|-0.18|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.18|-2.13|0.0207
71713099|NCT00619866|142942433|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.5||0.0038|TWO_SIDED|95.0|-2.42|-0.47|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.47|-2.42|0.0038
71713100|NCT00619866|142942434|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5744|TWO_SIDED|95.0|-0.18|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.18|0.5744
71713101|NCT00619866|142942434|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.728|TWO_SIDED|95.0|-0.17|0.12|||Repeated measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.17|0.7280
71713102|NCT00619866|142942434|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0195|TWO_SIDED|95.0|-0.32|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.32|0.0195
71713103|NCT00619866|142942434|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.5589|TWO_SIDED|95.0|-0.19|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.10|-0.19|0.5589
71713104|NCT00619866|142942434|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5558|TWO_SIDED|95.0|-0.2|0.11|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.11|-0.20|0.5558
71766692|NCT02184624|143035471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
71713105|NCT00619866|142942434|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08||0.7121|TWO_SIDED|95.0|-0.18|0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.12|-0.18|0.7121
71766693|NCT02184624|143035471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766694|NCT02184624|143035471|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766695|NCT02184624|143035472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766696|NCT02184624|143035472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
71766697|NCT02184624|143035472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766698|NCT02184624|143035472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766699|NCT02184624|143035472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766700|NCT02184624|143035473|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||0.480
71766701|NCT02184624|143035473|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||0.044
71766702|NCT02184624|143035473|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.025
71766703|NCT02184624|143035473|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766704|NCT02184624|143035473|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.014
71766705|NCT02184624|143035474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel|||||||<0.001
71766706|NCT02184624|143035474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel|||||||<0.001
71766707|NCT02184624|143035474|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel|||||||0.002
71656407|NCT01383421|142830946|SUPERIORITY||LS Mean Difference|-3.552|STANDARD_ERROR_OF_MEAN|1.561||0.023|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.023
71656408|NCT01383421|142830947|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|2.736||0.89|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.890
71656409|NCT01383421|142830947|SUPERIORITY||LS Mean Difference|-0.527|STANDARD_ERROR_OF_MEAN|2.523||0.835|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.835
71656410|NCT01383421|142830947|SUPERIORITY||LS Mean Difference|-0.471|STANDARD_ERROR_OF_MEAN|3.205||0.883|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.883
71656411|NCT01383421|142830947|SUPERIORITY||LS Mean Difference|-3.792|STANDARD_ERROR_OF_MEAN|1.611||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||0.019
71656412|NCT01383421|142830948|SUPERIORITY||LS Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|2.548||0.873|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism||||0.873
71656413|NCT01383421|142830948|SUPERIORITY||LS Mean Difference|-0.817|STANDARD_ERROR_OF_MEAN|2.598||0.753|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism||||0.753
71766708|NCT02184624|143035474|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel|||||||0.001
71766709|NCT02184624|143035474|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel|||||||0.003
71766710|NCT02184624|143035475|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
71766711|NCT02184624|143035475|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler|Wilcoxon signed rank test|||||||<0.001
71656414|NCT01383421|142830948|SUPERIORITY||LS Mean Difference|-2.334|STANDARD_ERROR_OF_MEAN|3.159||0.461|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment||||0.461
71656415|NCT01383421|142830948|SUPERIORITY||LS Mean Difference|-5.537|STANDARD_ERROR_OF_MEAN|1.624|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment||||<0.001
71656416|NCT01383421|142830949|SUPERIORITY||LS Mean Difference|2.973|STANDARD_ERROR_OF_MEAN|1.245||0.017|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.017
71656417|NCT01383421|142830949|SUPERIORITY||LS Mean Difference|2.843|STANDARD_ERROR_OF_MEAN|2.042||0.164|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.164
71656418|NCT01383421|142830949|SUPERIORITY||LS Mean Difference|5.473|STANDARD_ERROR_OF_MEAN|1.866||0.003|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.003
71656419|NCT01383421|142830949|SUPERIORITY||LS Mean Difference|1.705|STANDARD_ERROR_OF_MEAN|1.769||0.335|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.335
71656420|NCT01383421|142830950|SUPERIORITY||LS Mean Difference|2.728|STANDARD_ERROR_OF_MEAN|1.183||0.021|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.021
71766712|NCT02184624|143035475|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler|Wilcoxon signed rank test|||||||<0.001
71766713|NCT02184624|143035475|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler|Wilcoxon signed rank test|||||||<0.001
71766714|NCT02184624|143035475|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler|Wilcoxon signed rank test|||||||<0.001
71766715|NCT02184624|143035476|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766716|NCT02184624|143035476|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766717|NCT02184624|143035476|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71827776|NCT00371566|143159522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.93||0.394||95.0|-5.5|2.19|||ANCOVA|Null hypothesis or reject it in favor of the two sided alternative hypothesis||The study was designed to provide evidence to support the null hypothesis: Delta equals 0% or reject it in favor of the two sided alternative hypothesis: Delta does not equal 0%, where Delta was the difference in the true response rate for the two treatment groups.||2.19|-5.50|.394
71827777|NCT00972504|143159567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.2|-0.1||||||||-0.1|-1.2|
71827778|NCT00972504|143159567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.8|-0.8||||||||-0.8|-1.8|
71766718|NCT02184624|143035476|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766719|NCT02184624|143035476|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the 'preference' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71827779|NCT00972504|143159567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.9|-0.8||||||||-0.8|-1.9|
71766720|NCT02184624|143035477|SUPERIORITY_OR_OTHER||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766721|NCT02184624|143035477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766722|NCT02184624|143035477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766723|NCT02184624|143035477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766724|NCT02184624|143035477|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the 'ease of use' questionnaire|Cochran-Mantel-Haenszel|||||||<0.001
71766725|NCT02365233|143035483|SUPERIORITY||||||||||||||||||IRB withheld the data due to inadequate supporting documentation|||
71766726|NCT01978938|143035484|NON_INFERIORITY|The NI test was based on the lower limit of the 2-sided 95% confidence interval (CI), using the method proposed without stratification by Miettinen and Nurminen. If the lower limit of the 95% CI for the difference in Responder (clinical cure and microbiologic success) rates in the micro-ITT population exceeded -10%, then the null hypothesis was rejected and the NI of eravacycline to levofloxacin was declared.|Treatment Difference|-6.5|||||TWO_SIDED|95.0|-14.1|1.2||||||For the FDA, an NI margin of 10% was used, which was based on historical data regarding the treatment effect of antibiotics. A 10% NI margin for the Responder outcome is robust and can sufficiently confirm a clinically meaningful treatment effect of eravacycline in the treatment of cUTI.||1.2|-14.1|
71766727|NCT01947855|143035487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.87|STANDARD_ERROR_OF_MEAN|19.88|<|0.0001|TWO_SIDED|95.0|-144.77|-64.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-64.97|-144.77|<0.0001
71827780|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.0|0.3|||||Comparison of Nasal Blockage between Placebo and GSK1004723 1000 µg once daily.|||0.3|-0.0|
71827781|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily.|||-0.1|-0.4|
71827782|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily.|||-0.1|-0.4|
71827783|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
71827784|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.2|||||Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.6|
71827785|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.6|-0.3|||||Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily.|||-0.3|-0.6|
71656421|NCT01383421|142830950|SUPERIORITY||LS Mean Difference|3.124|STANDARD_ERROR_OF_MEAN|1.93||0.106|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.106
71656422|NCT01383421|142830950|SUPERIORITY||LS Mean Difference|5.572|STANDARD_ERROR_OF_MEAN|1.756||0.002|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||0.002
71656423|NCT01383421|142830950|SUPERIORITY||LS Mean Difference|1.885|STANDARD_ERROR_OF_MEAN|1.704||0.269|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.269
71656424|NCT01383421|142830951|SUPERIORITY||LS Mean Difference|2.324|STANDARD_ERROR_OF_MEAN|1.177||0.049|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience||||0.049
71656425|NCT01383421|142830951|SUPERIORITY||LS Mean Difference|4.929|STANDARD_ERROR_OF_MEAN|1.929||0.011|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness||||0.011
71656426|NCT01383421|142830951|SUPERIORITY||LS Mean Difference|5.997|STANDARD_ERROR_OF_MEAN|1.775|<|0.001|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction||||<0.001
71656427|NCT01383421|142830951|SUPERIORITY||LS Mean Difference|1.823|STANDARD_ERROR_OF_MEAN|1.657||0.272|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects||||0.272
71656428|NCT01383421|142830952|SUPERIORITY||LS Mean Difference|0.817|STANDARD_ERROR_OF_MEAN|0.572||0.154|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24||||0.154
71656429|NCT01383421|142830952|SUPERIORITY||LS Mean Difference|0.772|STANDARD_ERROR_OF_MEAN|0.599||0.198|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52||||0.198
71656430|NCT01383421|142830952|SUPERIORITY||LS Mean Difference|0.884|STANDARD_ERROR_OF_MEAN|0.585||0.131|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78||||0.131
71656431|NCT01383421|142830956|SUPERIORITY||LS Mean Between Group Change|0.1|STANDARD_ERROR_OF_MEAN|0.0429||0.019|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Necessity||||0.019
71656432|NCT01383421|142830956|SUPERIORITY||LS Mean Between Group Change|0.0|STANDARD_ERROR_OF_MEAN|0.0526||0.56|TWO_SIDED|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Concern||||0.560
71656433|NCT00807248|142830961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.96||0.6405|TWO_SIDED|95.0|-2.34|1.44|||ANCOVA|||||1.44|-2.34|0.6405
71656434|NCT00807248|142830961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.96||0.6227|TWO_SIDED|95.0|-1.41|2.35|||ANCOVA|||||2.35|-1.41|0.6227
71656435|NCT00807248|142830962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.98|-3.11|||ANCOVA|||||-3.11|-7.98|<0.0001
71656436|NCT00807248|142830962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-7.53|-2.66|||ANCOVA|||||-2.66|-7.53|<0.0001
71656437|NCT00807248|142830962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.24|<|0.0001|TWO_SIDED|95.0|-8.43|-3.56|||ANCOVA|||||-3.56|-8.43|<0.0001
71656438|NCT00807248|142830963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.98|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.13|-2.84|||ANCOVA|||||-2.84|-7.13|<0.0001
71656439|NCT00807248|142830963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-6.6|-2.32|||ANCOVA|||||-2.32|-6.60|<0.0001
71656440|NCT00807248|142830963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.27|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.41|-3.13|||ANCOVA|||||-3.13|-7.41|<0.0001
71656441|NCT00807248|142830964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58|||ANCOVA|||||-1.58|-4.59|<0.0001
71656442|NCT00807248|142830964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.15|-1.14|||ANCOVA|||||-1.14|-4.15|0.0006
71656443|NCT00807248|142830964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-5.13|-2.1|||ANCOVA|||||-2.10|-5.13|<0.0001
71656444|NCT00807248|142830965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.85|-0.64|||ANCOVA|||||-0.64|-1.85|<0.0001
71656445|NCT00807248|142830965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.72|-0.5|||ANCOVA|||||-0.50|-1.72|0.0004
71656446|NCT00807248|142830965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-1.87|-0.65|||ANCOVA|||||-0.65|-1.87|<0.0001
71656447|NCT00807248|142830966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.32||0.0007|TWO_SIDED|95.0|-1.72|-0.46|||ANCOVA|||||-0.46|-1.72|0.0007
71656448|NCT00807248|142830966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.33||0.0013|TWO_SIDED|95.0|-1.69|-0.41|||ANCOVA|||||-0.41|-1.69|0.0013
71656449|NCT00807248|142830966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.92|-0.66|||ANCOVA|||||-0.66|-1.92|<0.0001
71656450|NCT00807248|142830967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.31||0.0002|TWO_SIDED|95.0|-1.82|-0.58|||ANCOVA|||||-0.58|-1.82|0.0002
71656451|NCT00807248|142830967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.32||0.0006|TWO_SIDED|95.0|-1.72|-0.48|||ANCOVA|||||-0.48|-1.72|0.0006
71656452|NCT00807248|142830967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.0|-0.76|||ANCOVA|||||-0.76|-2.00|<0.0001
71827786|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.4|-0.1|||||Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily.|||-0.1|-0.4|
71827787|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily.|||-0.2|-0.5|
71827788|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily.|||-0.2|-0.5|
71827789|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily.|||-0.2|-0.5|
71827790|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.2|||||Comparison of Sneezing between Placebo and GSK835726 10mg once daily.|||-0.2|-0.4|
71827791|NCT00972504|143159568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and Cetirizine 10mg once daily.|||-0.2|-0.5|
71656453|NCT00807248|142830968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.34|||ANCOVA|||||-0.34|-0.89|<0.0001
71656454|NCT00807248|142830968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.82|-0.26|||ANCOVA|||||-0.26|-0.82|0.0001
71656455|NCT00807248|142830968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||||-0.44|-0.99|<0.0001
71656456|NCT00807248|142830969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5|||ANCOVA|||||-0.50|-1.02|<0.0001
71656457|NCT00807248|142830969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.88|-0.36|||ANCOVA|||||-0.36|-0.88|<0.0001
71656458|NCT00807248|142830969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.97|-0.45|||ANCOVA|||||-0.45|-0.97|<0.0001
71656459|NCT00609518|142830978|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09|||||TWO_SIDED|95.0|-0.1|0.28|||Linear probability model|||||0.28|-0.10|
71656460|NCT00609518|142830979|SUPERIORITY_OR_OTHER|||||||0.4902||95.0|||||Fisher Exact|||||||0.4902
71656461|NCT00609518|142830980|SUPERIORITY_OR_OTHER|||||||0.6791||95.0|||||Log Rank|||||||0.6791
71656462|NCT00609518|142830980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.54|1.49|||Regression, Cox|Treatment was the covariate included in this model.||||1.49|0.54|
71656463|NCT00609518|142830981|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Log Rank|||||||0.5870
71656464|NCT00609518|142830981|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.57|1.38|||Regression, Cox|Treatment was the covariate included in this model.||||1.38|0.57|
71656465|NCT00292188|142830983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.24||0.01||95.0|-1.09|-0.15|||ANCOVA|ANCOVA adjusted for treatment group, baseline mean pain score and pooled country||The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.||-0.15|-1.09|0.010
71656466|NCT00292188|142830984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.39||0.031||95.0|-1.6|-0.08|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.08|-1.60|0.031
71656467|NCT00292188|142830985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.003||95.0|-1.61|-0.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.33|-1.61|0.003
71656468|NCT00292188|142830986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|1.0||0.099||95.0|-3.69|0.32|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||0.32|-3.69|0.099
71656469|NCT00292188|142830987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|1.03||0.819||95.0|-1.87|2.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||2.34|-1.87|0.819
71656470|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.099||95.0|-0.56|0.05|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 1||0.05|-0.56|0.099
71656471|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.15||95.0|-0.62|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 2: FAS||0.10|-0.62|0.150
71656472|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01||95.0|-0.93|-0.13|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 3: FAS||-0.13|-0.93|0.010
71656473|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.137||95.0|-0.74|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 4: FAS||0.10|-0.74|0.137
71656474|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.041||95.0|-0.9|-0.02|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 5: FAS||-0.02|-0.90|0.041
71656475|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.009||95.0|-1.03|-0.15|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 6: FAS||-0.15|-1.03|0.009
71656476|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.25||0.035||95.0|-1.01|-0.04|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 7: FAS||-0.04|-1.01|0.035
71713106|NCT00619866|142942435|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.0286|TWO_SIDED|95.0|-0.54|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.03|-0.54|0.0286
71713107|NCT00619866|142942435|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.121|TWO_SIDED|95.0|-0.45|0.05|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.05|-0.45|0.1210
71713108|NCT00619866|142942435|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.68|-0.15|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.15|-0.68|0.0024
71713109|NCT00619866|142942435|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.76|-0.22|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.22|-0.76|0.0003
71713110|NCT00619866|142942435|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0021|TWO_SIDED|95.0|-0.72|-0.16|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.16|-0.72|0.0021
71713111|NCT00619866|142942435|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.24|-0.80|0.0003
71766728|NCT01947855|143035487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-85.49|STANDARD_ERROR_OF_MEAN|20.18|<|0.0001|TWO_SIDED|95.0|-126.01|-44.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.||-44.97|-126.01|<0.0001
71827792|NCT00972504|143159569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.041|STANDARD_ERROR_OF_MEAN|0.4194|||TWO_SIDED|95.0|-1.87|-0.212||||||||-0.212|-1.870|
71713112|NCT00619866|142942436|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0603|TWO_SIDED|95.0|-0.34|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.34|0.0603
71713113|NCT00619866|142942436|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.1855|TWO_SIDED|95.0|-0.29|0.06|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.06|-0.29|0.1855
71766729|NCT01012219|143035506|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||||1.56|0.96|
71766730|NCT01350544|143035539|SUPERIORITY||Odds Ratio (OR)|0.79||||0.005|TWO_SIDED|95.0|0.69|0.91||a priori threshold for significance for p \< .05|Mixed Models Analysis|||We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.||0.91|0.69|.005
71766731|NCT01369329|143035603|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
71827793|NCT00972504|143159569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.4172|||TWO_SIDED|95.0|-2.584|-0.936||||||||-0.936|-2.584|
71827794|NCT00972504|143159569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.792|STANDARD_ERROR_OF_MEAN|0.4224|||TWO_SIDED|95.0|-3.626|-1.957||||||||-1.957|-3.626|
71713114|NCT00619866|142942436|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0012|TWO_SIDED|95.0|-0.48|-0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||-0.12|-0.48|0.0012
71713115|NCT00619866|142942436|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1002|TWO_SIDED|95.0|-0.33|0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.03|-0.33|0.1002
71713116|NCT00619866|142942436|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0568|TWO_SIDED|95.0|-0.36|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.01|-0.36|0.0568
71713117|NCT00619866|142942436|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.119|TWO_SIDED|95.0|-0.33|0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.||0.04|-0.33|0.1190
71713118|NCT01968980|142942482|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-54.5|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-59.5|-49.5|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-49.5|-59.5|<0.001
71713119|NCT01968980|142942483|SUPERIORITY_OR_OTHER||LS mean difference|-37.6|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-41.1|-34.1|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-34.1|-41.1|<0.001
71713120|NCT01968980|142942484|SUPERIORITY_OR_OTHER||LS mean difference|-51.0|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-55.7|-46.4|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.4|-55.7|<0.001
71713121|NCT01968980|142942485|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-52.8|-43.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-43.2|-52.8|<0.001
71713122|NCT01968980|142942486|SUPERIORITY_OR_OTHER||LS mean difference|-28.6|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-33.9|-23.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-23.2|-33.9|<0.001
71713123|NCT01968980|142942487|SUPERIORITY_OR_OTHER||LS mean difference|7.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.1|9.9|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||9.9|4.1|<0.001
71713124|NCT01968980|142942488|SUPERIORITY_OR_OTHER||LS mean difference|-52.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-58.2|-46.0||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-46.0|-58.2|
71713125|NCT01968980|142942488|SUPERIORITY_OR_OTHER||LS mean difference|-48.0|STANDARD_ERROR_OF_MEAN|2.87|||TWO_SIDED|95.0|-53.6|-42.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.3|-53.6|
71713126|NCT01968980|142942489|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-40.0|-31.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-31.6|-40.0|
71713127|NCT01968980|142942489|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.8|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-35.8|-27.8||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-27.8|-35.8|
71713128|NCT01968980|142942490|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.5|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-54.1|-42.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-42.8|-54.1|
71713129|NCT01968980|142942490|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.2|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-47.5|-36.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-36.9|-47.5|
71827795|NCT00972504|143159570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|-0.28|0.93||||||||0.93|-0.28|
71827796|NCT00972504|143159570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-1.65|-0.45||||||||-0.45|-1.65|
71656477|NCT00292188|142830988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.019||95.0|-1.1|-0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 8: FAS||-0.10|-1.10|0.019
71656478|NCT00292188|142830989|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.032||95.0|1.05|3.21|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||30% responder||3.21|1.05|0.032
71656479|NCT00292188|142830989|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.78||||0.088||95.0|0.92|3.46|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||50% responder||3.46|0.92|0.088
71827797|NCT00972504|143159570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|0.308||||95.0|-1.68|-0.46||||||||-0.46|-1.68|
71827798|NCT01544062|143159583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.024|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.024
71827799|NCT01544062|143159583|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.013
71827800|NCT01544062|143159584|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||t-test, 2 sided|||||||0.059
71827801|NCT01544062|143159584|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.020
71656480|NCT00292188|142830990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|-1.25|-0.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||||-0.34|-1.25|0.001
71656481|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|2.62||0||95.0|-15.89|-5.55|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Disturbance||-5.55|-15.89|0.000
71656482|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|2.71||0.7||95.0|-4.3|6.4|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Snoring||6.40|-4.30|0.700
71656483|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|2.88||0.04||95.0|-11.62|-0.28|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Awaken Short of Breath/Headache||-0.28|-11.62|0.040
71656484|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.846||95.0|-0.92|0.76|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Quantity||0.76|-0.92|0.846
71656485|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.27||0.001||95.0|4.19|17.07|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Adequacy||17.07|4.19|0.001
71656486|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|2.34||0.324||95.0|-2.3|6.92|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Somnolence||6.92|-2.30|0.324
71656487|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|2.63||0||95.0|-14.71|-4.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-6||-4.33|-14.71|0.000
71656488|NCT00292188|142830991|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.02||0||95.0|-11.52|-3.56|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-9||-3.56|-11.52|0.000
71656489|NCT00292188|142830992|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.267||95.0|0.76|2.64|||Regression, Logistic|Logistic regression adjusted for treatment group, baseline score and pooled country.||||2.64|0.76|0.267
71656490|NCT00292188|142831000|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.84|STANDARD_ERROR_OF_MEAN|2.25||0.09||95.0|-8.28|0.61|||ANCOVA|||||0.61|-8.28|0.090
71656491|NCT00824616|142831010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.745|TWO_SIDED|95.0|-0.81|0.58|||Longitudinal Data Analysis (LDA) model|||||0.58|-0.81|0.745
71656492|NCT00824616|142831011|SUPERIORITY_OR_OTHER||Proportions|5.9||||0.537|TWO_SIDED|95.0|-13.7|25.4|||Miettinen & Nurminen method|||Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.||25.4|-13.7|0.537
71656493|NCT01796912|142831012|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71656494|NCT01796912|142831013|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71656495|NCT01796912|142831014|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71656496|NCT01796912|142831015|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
71656497|NCT01796912|142831016|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71656498|NCT01796912|142831017|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71656499|NCT01796912|142831018|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71656500|NCT01055132|142831061|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.|Least-square mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.0072|||TWO_SIDED|95.0|-0.041|-0.0013|||linear mixed model|Sequence of wear, period and lens were included as fixed effects; site, patient, eye\*patient, period\*patient and period\*eye\*patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.0013|-0.041|
71661040|NCT03433755|142835766|SUPERIORITY||Treatment Difference|-56.26|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|95.0|-62.44|-50.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-50.07|-62.44|< 0.0001
71766732|NCT01369329|143035603|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
71766733|NCT01369329|143035604|SUPERIORITY_OR_OTHER|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.003
71766734|NCT01369329|143035604|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
71713130|NCT01968980|142942491|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.8|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-52.1|-41.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-41.6|-52.1|
71713131|NCT01968980|142942491|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.5|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-45.5|-35.5||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-35.5|-45.5|
71713132|NCT01968980|142942492|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1|STANDARD_ERROR_OF_MEAN|12.58|||TWO_SIDED|95.0|-59.8|-10.3||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-10.3|-59.8|
71713133|NCT01968980|142942492|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-26.3|-4.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-4.4|-26.3|
71713134|NCT01968980|142942493|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|3.1|8.7||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||8.7|3.1|
71766735|NCT01369329|143035605|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
71713135|NCT01968980|142942493|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.1|5.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.9|-0.1|
71713136|NCT01968980|142942494|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
71713137|NCT01968980|142942494|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
71766736|NCT01369329|143035605|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
71713138|NCT01968980|142942494|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
71713139|NCT01968980|142942495|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|2.9|7.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||7.8|2.9|
71713140|NCT01968980|142942495|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|2.5|6.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||6.8|2.5|
71766737|NCT01369329|143035606|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||< 0.001
71766738|NCT01369329|143035606|SUPERIORITY_OR_OTHER|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.002
71766739|NCT01369329|143035607|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.009
71827802|NCT01544062|143159585|SUPERIORITY_OR_OTHER|||||||0.724|TWO_SIDED||||||t-test, 2 sided|||||||0.724
71713141|NCT01968980|142942495|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|0.5|5.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||5.4|0.5|
71713142|NCT01968980|142942496|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.3|3.6||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-2.3|
71713143|NCT01968980|142942496|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-1.9|3.2||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.2|-1.9|
71713144|NCT01968980|142942496|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-1.9|3.6||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||3.6|-1.9|
71713145|NCT01968980|142942497|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.7|-25.3|
71713146|NCT01968980|142942497|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-7.8|-27.0|
71713147|NCT01968980|142942497|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.04|||TWO_SIDED|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||0.4|-19.4|
71713148|NCT01968980|142942498|SUPERIORITY_OR_OTHER||LS Mean Difference|-78.8|STANDARD_ERROR_OF_MEAN|3.75|||TWO_SIDED|95.0|-86.2|-71.4||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-71.4|-86.2|
71713149|NCT01968980|142942499|SUPERIORITY_OR_OTHER||LS Mean Difference|-83.2|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-91.3|-75.0||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-75.0|-91.3|
71713150|NCT01968980|142942500|SUPERIORITY_OR_OTHER||LS Mean Difference|-87.0|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-95.4|-78.7||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-78.7|-95.4|
71766740|NCT01369329|143035607|SUPERIORITY_OR_OTHER|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.||||||0.001
71766741|NCT02984943|143035628|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
71713151|NCT01968980|142942501|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-59.2|-48.5||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-48.5|-59.2|
71713152|NCT01968980|142942502|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-14.7|-8.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-8.9|-14.7|
71713153|NCT01968980|142942503|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|2.0|4.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||4.9|2.0|
71713154|NCT01968980|142942504|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-2.2|-1.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.8|-2.2|
71713155|NCT01968980|142942504|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-2.1|-1.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.6|-2.1|
71713156|NCT01968980|142942504|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-1.8|-1.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-1.3|-1.8|
71766742|NCT02984943|143035629|OTHER|||||||0.1|||||||Skillings-Mack test|||||||0.10
71766743|NCT02984943|143035630|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
71766744|NCT02984943|143035631|OTHER|||||||0.02|||||||Skillings-Mack test|||||||0.02
71766745|NCT02984943|143035632|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
71713157|NCT01968980|142942505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.5|-0.4||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.5|
71713158|NCT01968980|142942505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.4||||||Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.4|-0.4|
71713159|NCT01968980|142942505|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region.||-0.3|-0.4|
71713160|NCT01968980|142942506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.8|||||TWO_SIDED|95.0|25.24|106.1||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||106.10|25.24|
71713161|NCT01968980|142942506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|66.9|||||TWO_SIDED|95.0|30.32|147.43||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||147.43|30.32|
71713162|NCT01968980|142942506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.8|||||TWO_SIDED|95.0|11.85|44.01||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||44.01|11.85|
71713163|NCT01968980|142942507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|200.8|||||TWO_SIDED|95.0|47.16|854.6||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||854.60|47.16|
71713164|NCT01968980|142942507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|228.0|||||TWO_SIDED|95.0|51.95|1000.39||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1000.39|51.95|
71713165|NCT01968980|142942507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|259.9|||||TWO_SIDED|95.0|34.87|1937.06||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.||1937.06|34.87|
71713166|NCT01474109|142942511|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.103||||0.706|TWO_SIDED|95.0|0.663|1.834|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 3 mg and in Placebo|||1.834|0.663|0.706
71713167|NCT01474109|142942511|SUPERIORITY_OR_OTHER||NB-2 estimate of new DUs per patient|1.268||||0.36|TWO_SIDED|95.0|0.763|2.106|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 10 mg and in Placebo|||2.106|0.763|0.360
71713168|NCT01474109|142942512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.875||||0.667|TWO_SIDED|95.0|0.477|1.606|||Chi-squared|||||1.606|0.477|0.6670
71713169|NCT01474109|142942512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.5518|TWO_SIDED|95.0|0.454|1.524|||Chi-squared|||||1.524|0.454|0.5518
71713170|NCT01474109|142942513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.696||||0.3625|TWO_SIDED|95.0|0.319|1.518|||Chi-squared|||||1.518|0.319|0.3625
71713171|NCT01474109|142942513|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9362|TWO_SIDED|95.0|0.498|2.133|||Chi-squared|||||2.133|0.498|0.9362
71713172|NCT01474109|142942514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.863|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.863
71713173|NCT01474109|142942514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.649|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.649
71713174|NCT01474109|142942515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.456|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.456
71713175|NCT01474109|142942515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.44|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.440
71713176|NCT01474109|142942516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.464|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.464
71713177|NCT01474109|142942516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.342|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.342
71713178|NCT02589938|142942517|SUPERIORITY|Repeated measures analysis of covariance (RMANCOVA) models were constructed to assess differences in each outcome adjusting for baseline outcome value, group, time, and group by time interaction assuming an unstructured covariance. The primary objective was assessed using a linear contrast of group effect at 4 weeks||||||0.0167|||||||ANCOVA|||The primary endpoint was to determine whether true acupuncture (TA) was more effective than sham acupuncture (SA) or standard oral hygiene (SOH) at treating xerostomia as assessed by the xerostomia questionnaire (XQ) at Week 4. The study was powered to detect a difference of 10 points with an assumed standard deviation (SD)=16 between each pair of groups on XQ.This assumed a t-test with a two-sided significance level of 0·0133 and 84% power with 20% dropout.||||0.0167
71713179|NCT02521285|142942520|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
71713180|NCT02521285|142942520|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||||||0.149
71713181|NCT02521285|142942521|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
71713182|NCT02521285|142942522|SUPERIORITY|||||||0.382|||||||t-test, 2 sided|||||||0.382
71713183|NCT02521285|142942522|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71713184|NCT02521285|142942523|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71713185|NCT02521285|142942523|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71713186|NCT02521285|142942524|SUPERIORITY|||||||0.234|||||||t-test, 2 sided|||||||0.234
71713187|NCT02521285|142942524|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||0.442
71766746|NCT02984943|143035633|OTHER|||||||0.004|||||||Skillings-Mack test|||||||0.004
71766747|NCT02984943|143035634|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
71766748|NCT02984943|143035635|OTHER|||||||0.2938|||||||Skillings-Mack test|||||||0.2938
71766749|NCT02984943|143035636|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
71766750|NCT02984943|143035637|OTHER|||||||0.0608|||||||Skillings-Mack test|||||||0.0608
71766751|NCT02984943|143035638|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
71766752|NCT02984943|143035639|OTHER|||||||0.1496|||||||Skillings-Mack test|||||||0.1496
71766753|NCT02984943|143035640|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
71766754|NCT02984943|143035641|OTHER|||||||0.36|||||||Skillings-Mack test|||||||0.36
71766755|NCT02984943|143035642|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
71766756|NCT02984943|143035643|OTHER|||||||0.0012|||||||Skillings-Mack test|||||||0.0012
71766757|NCT02984943|143035644|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
71766758|NCT02984943|143035645|OTHER|||||||0.9|||||||Skillings-Mack test|||||||0.90
71766759|NCT02984943|143035646|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
71827803|NCT01544062|143159585|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.510
71827804|NCT01544062|143159586|SUPERIORITY_OR_OTHER|||||||0.397|TWO_SIDED||||||t-test, 2 sided|||||||0.397
71661041|NCT03433755|142835766|SUPERIORITY||Treatment Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-62.35|-51.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-51.65|-62.35|< 0.0001
71766760|NCT02984943|143035647|OTHER|||||||0.0068|||||||Skillings-Mack test|||||||0.0068
71766761|NCT02984943|143035648|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
71766762|NCT02984943|143035649|OTHER|||||||0.0183|||||||Skillings-Mack test|||||||0.0183
71766763|NCT02984943|143035650|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
71766764|NCT02984943|143035651|OTHER|||||||0.08|||||||Skillings-Mack test|||||||0.08
71766765|NCT02984943|143035652|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766766|NCT02984943|143035653|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766767|NCT02984943|143035654|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766768|NCT02984943|143035655|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766769|NCT02984943|143035656|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766770|NCT02984943|143035657|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766771|NCT02984943|143035658|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766772|NCT02984943|143035660|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766773|NCT02984943|143035661|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766774|NCT02984943|143035662|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766775|NCT02984943|143035664|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766776|NCT02984943|143035665|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766777|NCT02984943|143035666|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766778|NCT02984943|143035667|OTHER||||||||||||||||||Descriptive statistics only were used|||
71766779|NCT02012582|143035689|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||Mixed model analysis for TIL with the patient as random effect and study day, cohort, treatment, and interaction between study day and treatment as fixed effects.|Mixed Models Analysis|||Placebo versus pooled VAS203 Arms/Groups||||<0.04
71766780|NCT02012582|143035690|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Placebo versus pooled VAS203 Arms/Group||||<0.01
71766781|NCT04740905|143035695|NON_INFERIORITY|If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.2|1.1|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. The final sample size provided \>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).||1.1|-2.2|
71766782|NCT04740905|143035695|SUPERIORITY||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4978|TWO_SIDED|95.0|-2.2|1.1||Tested at a two-sided 0.0497 significance level.|Mixed Model of Repeated Measures||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The final sample size provided \>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept.||1.1|-2.2|0.4978
71766783|NCT04740905|143035697|OTHER||Difference in CMH Weighted Percentage|-4.3|||||TWO_SIDED|95.0|-12.3|3.8||||||||3.8|-12.3|
71766784|NCT04740905|143035713|OTHER||Difference in Adjusted Means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||||||||1.1|-1.9|
71766785|NCT02412488|143035747|OTHER|"The goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision. The target sample size of approximately 200 subjects undergoing Reveal LINQ insertion was selected to ensure that the upper 95% confidence interval would be within 3 percentage points of the point estimate of the untoward event rate assuming the underlying rate was 2%"|Event Rate expressed as a percent|0.0|||||TWO_SIDED|95.0|0.0|2.1|||||The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage|"There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision."||2.1|0|
71827805|NCT01544062|143159586|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.458
71827806|NCT01544062|143159587|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.600
71827807|NCT01544062|143159587|SUPERIORITY_OR_OTHER|||||||0.509|TWO_SIDED||||||ANCOVA|controlling for age, sex and body mass index||||||0.509
71827808|NCT01544062|143159588|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||t-test, 2 sided|||||||0.399
71827809|NCT01544062|143159588|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.395
71713188|NCT02521285|142942525|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|||||||0.645
71713189|NCT02521285|142942525|SUPERIORITY|||||||0.878|||||||t-test, 2 sided|||||||0.878
71713190|NCT02521285|142942533|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
71713191|NCT02521285|142942534|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||Difference between arms||||0.397
71713192|NCT02521285|142942534|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||Difference in arms.||||0.983
71713193|NCT02521285|142942535|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
71713194|NCT02521285|142942535|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||0.203
71713195|NCT02521285|142942536|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
71713196|NCT02521285|142942536|SUPERIORITY|||||||0.343|||||||t-test, 2 sided|||||||0.343
71713197|NCT02521285|142942537|SUPERIORITY|||||||0.281|||||||t-test, 2 sided|||||||0.281
71713198|NCT02521285|142942537|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
71713199|NCT02521285|142942538|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
71713200|NCT02521285|142942538|SUPERIORITY|||||||0.195|||||||t-test, 2 sided|||||||0.195
71713201|NCT02521285|142942539|SUPERIORITY|||||||0.755|||||||t-test, 2 sided|||||||0.755
71713202|NCT02521285|142942539|SUPERIORITY|||||||0.432|||||||t-test, 2 sided|||||||0.432
71713203|NCT02521285|142942540|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
71713204|NCT02521285|142942540|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
71713205|NCT02521285|142942541|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
71713206|NCT02521285|142942541|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
71713207|NCT02521285|142942544|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|||||||0.518
71713208|NCT02521285|142942545|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
71713209|NCT02521285|142942545|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||||||0.505
71713210|NCT02521285|142942546|SUPERIORITY|||||||0.463|||||||t-test, 2 sided|||||||0.463
71713211|NCT02521285|142942546|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71713212|NCT02521285|142942547|SUPERIORITY|||||||0.105|||||||t-test, 2 sided|||||||0.105
71713213|NCT02521285|142942547|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71713214|NCT04537650|142942552|SUPERIORITY||Odds Ratio (OR)|21.0|||<|0.001|TWO_SIDED|95.0|1.8|243.24|||Chi-squared|||||243.24|1.8|<0.001
71713215|NCT04537650|142942553|SUPERIORITY||Odds Ratio (OR)|45.0|||<|0.001|TWO_SIDED|95.0|4.15|487.5|||Chi-squared|||||487.5|4.15|<0.001
71713216|NCT00879398|142942585|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
71713217|NCT00879398|142942586|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
71713218|NCT00879398|142942587|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|t-test, 2 sided|||||||<0.0001
71713219|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Statistical significant level: 0.05|Chi-squared|||Geriatric Status: \<65 years versus (vs) Geriatric Status: ≥65 years||||0.1319
71713220|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age Categories: \<50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.||||0.6010
71713221|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.0289||95.0||||Statistical significant level: 0.05|Chi-squared|||Male vs Female||||0.0289
71713222|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.3078||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Weight Categories: \<50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.||||0.3078
71713223|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.9614||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Height Categories: \<160 cm, 160 to 170 cm, and ≥170 cm.||||0.9614
71713224|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.0788||95.0||||Statistical significant level: 0.05|Fisher Exact|||Allergic History: Yes vs Allergic History: No||||0.0788
71713225|NCT00879398|142942589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Duration of Disease: \<1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.||||<0.0001
71713226|NCT00879398|142942589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Past OAB Treatment History: Yes vs Past OAB Treatment History: No||||<0.0001
71713227|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.1147||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Past Disease: Yes vs Medical History of Past Disease: No||||0.1147
71713228|NCT00879398|142942589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Medical History of Present Disease: Yes vs Medical History of Present Disease: No||||<0.0001
71713229|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Kidney Disorder: Yes vs Kidney Disorder: No||||1.0000
71713230|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||1||95.0||||Statistical significant level: 0.05|Fisher Exact|||Liver Disorder: Yes vs Liver Disorder: No||||1.0000
71713231|NCT00879398|142942589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Comparison among Total Administration Period of Toviaz Subgroups: \<2 months, 2 to 4 months, and ≥4 months.||||<0.0001
71713232|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.0239||95.0||||Statistical significant level: 0.05|Fisher Exact|||Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, \>4 mg to \<8 mg, and 8 mg.||||0.0239
71713233|NCT00879398|142942589|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Statistical significant level: 0.05|Chi-squared|||Completion vs Discontinuation||||<0.0001
71713234|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.5889||95.0||||Statistical significant level: 0.05|Fisher Exact|||Total Administration Period \<274 days vs Total Administration Period ≥ 274 days||||0.5889
71713235|NCT00879398|142942589|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significant level: 0.05|Chi-squared|||Concurrent Medication: Yes vs Concurrent Medication: No||||0.0010
71713236|NCT00375713|142942590|NON_INFERIORITY_OR_EQUIVALENCE|The pre-set threshold for non inferiority is -10%.|Difference in proportion of responders|0.00069213||||||95.0|-0.0875|0.0888||||||The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.||0.0888|-0.0875|
71766786|NCT03222492|143035762|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
71766787|NCT03222492|143035762|SUPERIORITY|||||||0.444||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.444
71766788|NCT03222492|143035763|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
71766789|NCT03222492|143035763|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.400
71766790|NCT03222492|143035764|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
71766791|NCT03222492|143035764|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
71766792|NCT03222492|143035764|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
71766793|NCT03222492|143035764|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
71766794|NCT03222492|143035764|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
71766795|NCT03222492|143035764|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.500
71827810|NCT01544062|143159589|SUPERIORITY_OR_OTHER|||||||0.771|TWO_SIDED||||||t-test, 2 sided|||||||0.771
71827811|NCT01544062|143159589|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.927
71661042|NCT03433755|142835767|SUPERIORITY||Treatment difference|-55.69|STANDARD_ERROR_OF_MEAN|3.67|<|0.0001|TWO_SIDED|95.0|-62.98|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-48.41|-62.98|< 0.0001
71766796|NCT03222492|143035765|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
71766797|NCT03222492|143035765|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
71766798|NCT03222492|143035766|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||1.000
71766799|NCT03222492|143035766|SUPERIORITY|||||||0.467||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.467
71766800|NCT03222492|143035767|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||1.000
71766801|NCT03222492|143035767|SUPERIORITY|||||||0.4||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.400
71766802|NCT03222492|143035768|SUPERIORITY|||||||0.464||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.464
71766803|NCT03222492|143035768|SUPERIORITY|||||||0.5||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.500
71766804|NCT03222492|143035768|SUPERIORITY|||||||0.25||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.250
71766805|NCT03222492|143035768|SUPERIORITY|||||||0.167||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.167
71766806|NCT03222492|143035768|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.083
71766807|NCT03222492|143035768|SUPERIORITY|||||||0.083||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.083
71766808|NCT03222492|143035769|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||1.000
71827812|NCT01544062|143159590|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||t-test, 2 sided|||||||0.644
71827813|NCT01544062|143159590|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.160
71827814|NCT01544062|143159591|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||t-test, 2 sided|||||||0.710
71827815|NCT01544062|143159591|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.475
71827816|NCT01544062|143159592|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|||||||0.508
71827817|NCT01544062|143159592|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED|||||controlling for age, sex and body mass index|ANCOVA|||||||0.905
71827818|NCT01544062|143159593|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||t-test, 2 sided|||||||0.104
71766809|NCT03222492|143035769|SUPERIORITY|||||||0.429||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 12||||0.429
71766810|NCT03222492|143035770|SUPERIORITY|||||||0.286||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.286
71766811|NCT03222492|143035770|SUPERIORITY|||||||0.067||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 24||||0.067
71766812|NCT03222492|143035771|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 36||||0.100
71766813|NCT03222492|143035772|SUPERIORITY|||||||0.1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||0.100
71766814|NCT03222492|143035783|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
71766815|NCT03222492|143035783|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
71766816|NCT03222492|143035784|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||||||1.000
71656501|NCT01055132|142831062|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0062|||TWO_SIDED|95.0|-0.027|-0.003|||linear mixed model|Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period\*patient were included as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.||-0.003|-0.027|
71656502|NCT01055132|142831063|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|11.9|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|95.0|4.05|19.79|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.||19.79|4.05|
71656503|NCT01055132|142831064|NON_INFERIORITY_OR_EQUIVALENCE|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|least-square mean difference|7.7|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|0.58|14.8|||linear mixed model|Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.|Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.||14.80|0.58|
71656504|NCT00158600|142831066|SUPERIORITY_OR_OTHER||Difference|28.12||||0.0347||95.0|2.07|54.17||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in distance walked from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||54.17|2.07|0.0347
71656505|NCT00158600|142831067|SUPERIORITY_OR_OTHER||Difference|3.4||||0.0055||95.0|1.03|5.77||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in % predicted FVC from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||5.77|1.03|0.0055
71656506|NCT00158600|142831068|SUPERIORITY_OR_OTHER||Difference|3.18||||0.1093||95.0|-0.73|7.08||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in QMT from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||7.08|-0.73|0.1093
71656507|NCT00158600|142831069|SUPERIORITY_OR_OTHER||Difference|-0.37||||0.8333||95.0|-3.83|3.09||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in PCS from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.||3.09|-3.83|0.8333
71656508|NCT02618408|142831073|SUPERIORITY||Median Difference (Net)|-7.08||||0.0916|TWO_SIDED|95.0|-15.38|1.22|||Wilcoxon (Mann-Whitney)|||||1.22|-15.38|0.0916
71766817|NCT03222492|143035784|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 48||||1.000
71766818|NCT02189954|143035793|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71766819|NCT02189954|143035793|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mann Whitney U|||||||<0.05
71766820|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.659|STANDARD_ERROR_OF_MEAN|0.0642|<|0.0001|TWO_SIDED|80.0|-61.95|-55.08|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-55.08|-61.95|<0.0001
71766821|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-68.026|STANDARD_ERROR_OF_MEAN|0.0665|<|0.0001|TWO_SIDED|80.0|-70.66|-65.16|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-65.16|-70.66|<0.0001
71713237|NCT00375713|142942591|SUPERIORITY_OR_OTHER|||||||0.4369||95.0|||||ANCOVA|Pruritus score is adjusted on pruritus Baseline score.||The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor||||0.4369
71713238|NCT00375713|142942592|SUPERIORITY_OR_OTHER|||||||0.3549||95.0|||||ANCOVA|pruritus severity score at baseline has been used as a covariate.||The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.||||0.3549
71713239|NCT00375713|142942593|SUPERIORITY_OR_OTHER|||||||0.7518||95.0|||||Cochran-Mantel-Haenszel|stratified on the prurity severity score at the previous day of randomization.||||||0.7518
71713240|NCT02769481|142942611|NON_INFERIORITY|A 95% CI was to be calculated to estimate the range of values in which the treatment difference was likely to lie. If the 95% CI fell below the specified non inferiority margin of 0.35%, the non inferiority of bexagliflozin treatment to glimepiride treatment would be demonstrated and the null hypothesis would be rejected.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.21|0.11|||||A lower value represents a better treatment effect.|The null hypothesis for the primary endpoint was that the change in HbA1c from baseline to week 60 in the bexagliflozin arm would be greater than change in the glimepiride arm by greater than 0.35%.||0.11|-0.21|
71713241|NCT02769481|142942612|SUPERIORITY||Difference of LS Means|-4.31|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.52||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-3.52|-5.10|< 0.0001
71713242|NCT02769481|142942613|SUPERIORITY||Difference of LS Means|-6.53||||0.0008|TWO_SIDED|95.0|-10.56|-2.51||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, background treatment, baseline HbA1c, baseline eGFR, treatment, visit, treatment-by-visit and baseline weight as a fixed effect covariate.||||-2.51|-10.56|0.0008
71713243|NCT02769481|142942614|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.28||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline HbA1c, background treatment, eGFR at baseline, treatment as a fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over glimepiride.|||0.28|0.05|< 0.0001
71766822|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.152|STANDARD_ERROR_OF_MEAN|0.0643|<|0.0001|TWO_SIDED|80.0|-87.26|-84.95|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-84.95|-87.26|<0.0001
71766823|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.558|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-44.7|-36.1|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-36.10|-44.70|<0.0001
71713244|NCT02769481|142942615|SUPERIORITY|Superiority of bexagliflozin over glimepiride in HbA1c reduction from baseline to week 60 will be declared if the upper bound of 95% confidence interval is less than 0|Difference of LS Means|-0.05|||||TWO_SIDED|95.0|-0.21|0.11||||||||0.11|-0.21|
71713245|NCT04604431|142942632|SUPERIORITY||Odds Ratio (OR)|14.1|||<|0.001|TWO_SIDED|95.0|6.9|29.1|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for low-risk infants.||29.1|6.9|<0.001
71713246|NCT04604431|142942632|SUPERIORITY||Odds Ratio (OR)|3.1||||0.034|TWO_SIDED|95.0|1.1|8.8|||Mixed Models Analysis|||Odds ratios will be computed to describe the odds of adherence for the iREACH intervention compared to the control intervention for high-risk infants.||8.8|1.1|0.034
71766824|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.368|STANDARD_ERROR_OF_MEAN|0.0561|<|0.0001|TWO_SIDED|80.0|-54.78|-47.7|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-47.70|-54.78|<0.0001
71766825|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.583|STANDARD_ERROR_OF_MEAN|0.0558|<|0.0001|TWO_SIDED|80.0|-62.4|-56.56|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.56|-62.40|<0.0001
71713247|NCT00643279|142942637|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|91.5|||||ONE_SIDED|95.0|88.7||||||||||88.7|
71713248|NCT00643279|142942638|SUPERIORITY|Survival estimate at 6-months|6-month survival rate|100.0|||||ONE_SIDED|95.0|98.9||||||||||98.9|
71713249|NCT04603560|142942646|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.54|1.66|||||The odds ratio represents Social Norming vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||1.66|0.54|
71713250|NCT04603560|142942646|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.72|2.29|||||The odds ratio represents Pharmacist E-Detailing vs Control.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size||2.29|0.72|
71766826|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.373|STANDARD_ERROR_OF_MEAN|0.1007|<|0.0001|TWO_SIDED|80.0|-45.06|-28.62|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-28.62|-45.06|<0.0001
71766827|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.018|STANDARD_ERROR_OF_MEAN|0.1001|<|0.0001|TWO_SIDED|80.0|-51.72|-37.38|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-37.38|-51.72|<0.0001
71766828|NCT02509117|143035832|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.797|STANDARD_ERROR_OF_MEAN|0.1014|<|0.0001|TWO_SIDED|80.0|-66.51|-56.42|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.||-56.42|-66.51|<0.0001
71766829|NCT01332461|143035845|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649||||0.05|TWO_SIDED|95.0|0.455|0.926|||Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.926|0.455|0.05
71766830|NCT01332461|143035846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601|||<|0.05|TWO_SIDED|95.0|0.326|1.109||COPD-related hospitalization|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.109|0.326|<0.05
71656509|NCT02618408|142831073|SUPERIORITY||Median Difference (Net)|-1.76||||0.7136|TWO_SIDED|95.0|-11.78|8.27|||Wilcoxon (Mann-Whitney)|||Based on the results of a prespecified interim analysis, the enrollment of the low dose SPN-810 arm was halted, and this treatment arm was dropped. Accordingly, all analysis of primary and secondary endpoints focused on the comparison of SPN-810 high dose and placebo||8.27|-11.78|0.7136
71656510|NCT02618408|142831074|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0238|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||||-0.03|-0.46|0.0238
71656511|NCT02618408|142831074|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0683|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.02|-0.47|0.0683
71656512|NCT02618408|142831074|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.136||0.0742|TWO_SIDED|95.0|-0.51|0.02|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.02|-0.51|0.0742
71766831|NCT01332461|143035846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651|||<|0.05|TWO_SIDED|95.0|0.434|0.977||COPD-related ER visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.977|0.434|<0.05
71827819|NCT01544062|143159594|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|||||||0.580
71656513|NCT02618408|142831075|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.105||0.3713|TWO_SIDED|95.0|-0.3|0.11|||Mixed Models Analysis|||||0.11|-0.30|0.3713
71656514|NCT02618408|142831075|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.1367|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.06|-0.45|0.1367
71656515|NCT02618408|142831075|SUPERIORITY||Median Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.146||0.1729|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.09|-0.49|0.1729
71656516|NCT02618408|142831076|SUPERIORITY||Mean Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|1.456||0.1407|TWO_SIDED|95.0|-0.72|5.02|||ANCOVA|||This analysis pertains to the physical functioning summary score at Visit 6.||5.02|-0.72|0.1407
71656517|NCT02618408|142831076|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.898||0.5586|TWO_SIDED|95.0|-2.29|1.24|||ANCOVA|||This analysis pertains to the psychosocial health summary score at Visit 6||1.24|-2.29|0.5586
71656518|NCT02618408|142831077|SUPERIORITY||Median Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|2.07||0.7637|TWO_SIDED|95.0|-4.7|3.45|||ANCOVA|||This analysis pertains to the Total Stress summary score Visit 6.||3.45|-4.70|0.7637
71656519|NCT02618408|142831077|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.895||0.8365|TWO_SIDED|95.0|-1.95|1.58|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.58|-1.95|0.8365
71656520|NCT02618408|142831077|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_ERROR_OF_MEAN|0.829||0.4606|TWO_SIDED|95.0|-2.24|1.02|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.02|-2.24|0.4606
71656521|NCT02618408|142831077|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.837||0.8222|TWO_SIDED|95.0|-1.84|1.46|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||1.46|-1.84|0.8222
71656522|NCT02618408|142831078|SUPERIORITY|This analysis pertains to Visit 4|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.1031|TWO_SIDED|95.0|-0.43|0.04|||Mixed Models Analysis|||||0.04|-0.43|0.1031
71656523|NCT02618408|142831078|SUPERIORITY|This analysis pertains to Visit 5|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.132||0.025|TWO_SIDED|95.0|-0.56|-0.04|||Mixed Models Analysis|||||-0.04|-0.56|0.0250
71656524|NCT02618408|142831078|SUPERIORITY|This analysis pertains to Visit 6|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.158||0.0384|TWO_SIDED|95.0|-0.64|-0.02|||Mixed Models Analysis|||||-0.02|-0.64|0.0384
71656525|NCT02618408|142831079|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.084||0.1935|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||This analysis pertains to the inattention subscale at Visit 6.||0.06|-0.27|0.1935
71656526|NCT02618408|142831079|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.092||0.1445|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|||This analysis pertains to hyperactivity/Impulsivity subscale at Visit 6||0.05|-0.32|0.1445
71656527|NCT02618408|142831079|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1064|TWO_SIDED|95.0|-0.36|0.03|||ANCOVA|||This analysis pertains to the oppositional defiant disorder subscale at Visit 6||0.03|-0.36|0.1064
71656528|NCT02618408|142831079|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.082||0.1418|TWO_SIDED|95.0|-0.28|0.04|||ANCOVA|||This analysis pertains to the combined scale score at Visit 6||0.04|-0.28|0.1418
71656529|NCT02566993|142831099|SUPERIORITY||Hazard Ratio (HR)|0.967||||0.9029|TWO_SIDED|95.0|0.815|1.148|||Log Rank|Stratified log-rank test||||1.148|0.815|0.9029
71656530|NCT02566993|142831100|SUPERIORITY|||||||0.2826|||||||Normal test|||||||0.2826
71656531|NCT02566993|142831101|SUPERIORITY|||||||0.6216|||||||Normal test|||||||0.6216
71656532|NCT02566993|142831102|SUPERIORITY|||||||0.9708|||||||Normal test|||||||0.9708
71656533|NCT02566993|142831103|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.3257|TWO_SIDED|95.0|0.693|0.996|||Log Rank|Stratified log-rank test||||0.996|0.693|0.3257
71656534|NCT02566993|142831104|SUPERIORITY|||||||0.0851|||||||Normal test|||||||0.0851
71656535|NCT02566993|142831105|SUPERIORITY|||||||0.0129|||||||Normal test|||||||0.0129
71656536|NCT02566993|142831107|SUPERIORITY|||||||0.6616|||||||Binomial test|||||||0.6616
71656537|NCT02566993|142831108|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.0012|TWO_SIDED|95.0|0.416|0.812|||Log Rank|||||0.812|0.416|0.0012
71656538|NCT02566993|142831109|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.744|1.14||||||||1.140|0.744|
71656539|NCT02566993|142831110|SUPERIORITY||Hazard Ratio (HR)|0.688|||||TWO_SIDED|95.0|0.549|0.863||||||||0.863|0.549|
71656540|NCT02566993|142831112|SUPERIORITY||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.616|1.376||||||||1.376|0.616|
71656541|NCT02566993|142831113|SUPERIORITY||Hazard Ratio (HR)|0.504|||||TWO_SIDED|95.0|0.346|0.736||||||||0.736|0.346|
71656542|NCT02566993|142831114|SUPERIORITY||Hazard Ratio (HR)|1.122|||||TWO_SIDED|95.0|0.84|1.5||||||||1.500|0.840|
71656543|NCT02566993|142831115|SUPERIORITY||Hazard Ratio (HR)|1.306|||||TWO_SIDED|95.0|0.955|1.786||||||||1.786|0.955|
71766832|NCT01332461|143035846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.815|||<|0.05|TWO_SIDED|95.0|0.658|1.008||COPD-related physician + Rx visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||1.008|0.658|<0.05
71766833|NCT01332461|143035846|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.785|||<|0.05|TWO_SIDED|95.0|0.649|0.948||COPD-related hospitalization/ER visit/physician+Rx|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.|||0.948|0.649|<0.05
71766834|NCT02199717|143035863|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.||||0.32
71766835|NCT02199717|143035864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|306.4|||<|0.01|TWO_SIDED|95.0|254.8|358.0|||Wilcoxon (Mann-Whitney)|||||358|254.8|<0.01
71656544|NCT02566993|142831117|SUPERIORITY||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.455|1.843||||||||1.843|0.455|
71766836|NCT03567343|143035865|EQUIVALENCE|Significance set to 0.05|Mean Difference (Net)|-2.1||||0.1543|TWO_SIDED|95.0|-5.03|0.82||The threshold for statistical significance was P\< 0.05.|Paired T-test|||||0.82|-5.03|0.1543
71766837|NCT03567343|143035865|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.53||||0.1827|TWO_SIDED|95.0|-6.3|1.24|||Paired T-test|||||1.24|-6.3|0.1827
71656545|NCT02566993|142831118|SUPERIORITY||Hazard Ratio (HR)|1.092|||||TWO_SIDED|95.0|0.506|2.36||||||||2.360|0.506|
71656546|NCT02566993|142831119|SUPERIORITY||Hazard Ratio (HR)|0.923|||||TWO_SIDED|95.0|0.765|1.113||||||||1.113|0.765|
71656547|NCT02566993|142831120|SUPERIORITY||Hazard Ratio (HR)|0.788|||||TWO_SIDED|95.0|0.645|0.961||||||||0.961|0.645|
71656548|NCT02566993|142831122|SUPERIORITY||Hazard Ratio (HR)|0.903|||||TWO_SIDED|95.0|0.624|1.307||||||||1.307|0.624|
71656549|NCT02566993|142831123|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.392|0.799||||||||0.799|0.392|
71656550|NCT02566993|142831124|SUPERIORITY||Hazard Ratio (HR)|1.291|||||TWO_SIDED|95.0|0.838|1.99||||||||1.990|0.838|
71656551|NCT02566993|142831125|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.824|2.019||||||||2.019|0.824|
71656552|NCT02566993|142831127|SUPERIORITY||Hazard Ratio (HR)|1.032|||||TWO_SIDED|95.0|0.403|2.641||||||||2.641|0.403|
71656553|NCT02566993|142831128|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.373|2.75||||||||2.750|0.373|
71656554|NCT03127644|142831148|SUPERIORITY||Treatment difference in slopes|-0.00496|STANDARD_ERROR_OF_MEAN|0.00038|<|0.0001|TWO_SIDED|95.0|-0.00571|-0.0042|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00420|-0.00571|<0.0001
71656555|NCT03127644|142831148|SUPERIORITY||Treatment difference in slopes|-0.00261|STANDARD_ERROR_OF_MEAN|0.000385|<|0.001|TWO_SIDED|95.0|-0.00337|-0.00185|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).||-0.00185|-0.00337|<0.001
71656556|NCT03127644|142831149|SUPERIORITY||Odds Ratio (OR)|46.495|||<|0.0001|TWO_SIDED|95.0|10.142|213.152|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||213.152|10.142|<0.0001
71656557|NCT03127644|142831149|SUPERIORITY||Odds Ratio (OR)|71.835|||<|0.0001|TWO_SIDED|95.0|13.497|382.337|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||382.337|13.497|<0.0001
71656558|NCT03127644|142831150|SUPERIORITY||Treatment difference in slopes|-0.00231|STANDARD_ERROR_OF_MEAN|0.000645||0.0004|TWO_SIDED|95.0|-0.00359|-0.00104|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00104|-0.00359|0.0004
71656559|NCT03127644|142831150|OTHER||Treatment difference in slopes|-0.00401|STANDARD_ERROR_OF_MEAN|0.000637|<|0.0001|TWO_SIDED|95.0|-0.00527|-0.00275|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).||-0.00275|-0.00527|<0.0001
71656560|NCT03127644|142831151|SUPERIORITY||Odds Ratio (OR)|1.347||||0.6167|TWO_SIDED|95.0|0.419|4.329|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||4.329|0.419|0.6167
71656561|NCT03127644|142831151|SUPERIORITY||Odds Ratio (OR)|15.334|||<|0.0001|TWO_SIDED|95.0|4.006|58.697|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.||58.697|4.006|<0.0001
71766838|NCT03567343|143035866|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.8165|TWO_SIDED|95.0|-1.96|1.56|||Paired T-test|||||1.56|-1.96|0.8165
71766839|NCT03567343|143035866|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.58||||0.1821|TWO_SIDED|95.0|-0.77|3.94|||Paired T-test|||||3.94|-0.77|0.1821
71766840|NCT03567343|143035867|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.94||||0.0156|TWO_SIDED|95.0|4.19|37.69|||Paired T-test|||||37.69|4.19|0.0156
71766841|NCT03567343|143035867|EQUIVALENCE|P\<0.05|Mean Difference (Net)|20.08||||0.0572|TWO_SIDED|95.0|-0.64|40.8|||Paired T-test|||||40.8|-0.64|0.0572
71766842|NCT03567343|143035868|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-4.48||||0.0781|TWO_SIDED|95.0|-9.37|0.41|||Paired T-test|||||0.41|-9.37|0.0781
71766843|NCT03567343|143035868|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-3.0||||0.242|TWO_SIDED|95.0|-8.1|2.1|||Paired T-test|||||2.1|-8.1|0.242
71766844|NCT03567343|143035869|EQUIVALENCE|P\<0.05|Mean Difference (Net)|2.91||||0.0195|TWO_SIDED|95.0|0.49|5.32|||Paired T-test|||||5.32|0.49|0.0195
71766845|NCT03567343|143035869|EQUIVALENCE|P\<0.05|Mean Difference (Net)|4.66||||0.0097|TWO_SIDED|95.0|1.19|8.12|||Paired T-test|||||8.12|1.19|0.0097
71766846|NCT03567343|143035870|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.93|||<|0.0001|TWO_SIDED|95.0|0.59|1.28|||Paired T-test|||||1.28|0.59|<0.0001
71766847|NCT03567343|143035870|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.45||||0.0179|TWO_SIDED|95.0|0.08|0.81|||Paired T-test|||||0.81|0.08|0.0179
71827820|NCT01544062|143159595|SUPERIORITY_OR_OTHER|||||||0.619|TWO_SIDED||||||Fisher Exact|||||||0.619
71827821|NCT01544062|143159596|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||Fisher Exact|||||||0.511
71827822|NCT01544062|143159597|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||Fisher Exact|||||||0.501
71713251|NCT04603560|142942646|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.74|2.56|||||The odds ratio represents Pharmacist e-detailing vs Social Norming.|Generalized estimating equation adjusting for clustering of patients within providers as well as provider panel size.||2.56|0.74|
71827823|NCT01544062|143159598|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71827824|NCT01544062|143159599|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||||||0.299
71827825|NCT01544062|143159600|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71827826|NCT01544062|143159601|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Fisher Exact|||||||0.492
71827827|NCT01544062|143159602|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||||||0.455
71827828|NCT01544062|143159603|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71827829|NCT00768651|143159610|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.||||< 0.05
71827830|NCT03772964|143159635|SUPERIORITY|Comparisons between samples and sample groups (beta-diversity), were evaluated with ADONIS (aka PERMANOVA) comparisons of differences between sample groups.|R2|0.071435|||<|0.01|TWO_SIDED||||||ADONISBeta Diversity|Comparisons between samples and sample groups (beta-diversity) were evaluated with ADONIS (aka PERMANOVA)|R2 values estimate the amount of variation explained by each variable.|Beta Diversity - Differences between Samples and Sample groups||||<0.01
71827831|NCT03772964|143159636|SUPERIORITY|||||||0.6057|||||||ANOVA|||||||0.6057
71827832|NCT03772964|143159638|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71827833|NCT03772964|143159639|SUPERIORITY|||||||0.69|||||||ANOVA|||||||0.69
71827834|NCT03538054|143159647|SUPERIORITY||Slope|-5.065||||0.146|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.146
71827835|NCT03538054|143159648|SUPERIORITY||Slope|4.221||||0.052|TWO_SIDED|||||The clinical threshold was p \< 0.05, with no corrections for multiple comparisons.|GEE|Outcome scores were mean-centered by participant, allowing analyses to reflect within-person changes rather than between-person differences.||||||0.052
71656562|NCT03127644|142831155|SUPERIORITY|||||||0.0586||||||Nominal p value|Log Rank|||||||0.0586
71656563|NCT03127644|142831155|SUPERIORITY|||||||0.0006||||||Nominal p value|Log Rank|||||||0.0006
71656564|NCT03127644|142831156|SUPERIORITY|||||||0.025||||||Nominal p value|Log Rank|||||||0.0250
71656565|NCT03127644|142831156|SUPERIORITY|||||||0.0064||||||Nominal p value|Log Rank|||||||0.0064
71656566|NCT04972123|142831167|SUPERIORITY|The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||||||0.521||||||The primary end point was evaluated via a large sample Z-test for proportions. The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.|Large sample Z-test for population prop|The test statistic was compared to a Pocock monitoring boundary at both an interim analysis and at the final analysis.||Primary endpoint -- ITT primary endpoint analysis||||0.521
71656567|NCT04972123|142831168|SUPERIORITY|Time to event was compared between groups via a log-rank test.||||||0.574||||||Time to event was compared between groups via a log-rank test.|Log Rank|||Secondary endpoint -- Time to event for evaluable ITT population who had a primary event.||||0.574
71656568|NCT04972123|142831169|SUPERIORITY|Incidence of asystole were compared between groups using Fisher exact test.||||||1||||||Incidence of asystole were compared between groups using Fisher exact test.|Fisher Exact|Incidence of asystole were compared between groups using Fisher exact test.||Secondary endpoint -- Incidence of asystolic pause \> 3 seconds for evaluable ITT population who had a primary event.||||1.000
71656569|NCT04972123|142831170|SUPERIORITY|Reporting for the 1 hour fatigue score only.||||||0.732||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.732
71656570|NCT04972123|142831170|SUPERIORITY|Reporting for the 4 hour fatigue score only.||||||0.591||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.591
71656571|NCT04972123|142831170|SUPERIORITY|Reporting for the 8 hour fatigue score only.||||||0.034||||||Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.|Wilcoxon (Mann-Whitney)|Measures of fatigue were compared between groups using the Wilcoxon rank-sum test.||Secondary endpoint -- Measures of Fatigue for evaluable ITT population who had a primary event.||||0.034
71656572|NCT01156142|142831171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.7|-2.1|||Wilcoxon (Mann-Whitney)|||||-2.1|-6.7|<0.001
71656573|NCT01156142|142831172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0018|TWO_SIDED|95.0|0.1|5.1|||Wilcoxon (Mann-Whitney)|||||5.1|0.1|0.0018
71656574|NCT01156142|142831173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6||||0.001|TWO_SIDED|95.0|2.9|8.3|||Wilcoxon (Mann-Whitney)|||||8.3|2.9|0.001
71656575|NCT01156142|142831174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.0297|TWO_SIDED|95.0|-1.2|4.6|||Wilcoxon (Mann-Whitney)|||||4.6|-1.2|0.0297
71656576|NCT01156142|142831175|SUPERIORITY_OR_OTHER|||||||0.1392|||||||Chi-squared|||At 2 hours after initial mouthwash||||0.1392
71656577|NCT01156142|142831175|SUPERIORITY_OR_OTHER|||||||0.6989|||||||Chi-squared|||At 4 hours after initial mouthwash||||0.6989
71713252|NCT05715827|142942647|OTHER|The study used descriptive statistics and 95% confidence intervals to summarize data. The sample size of 40 patients (20 per surgery type) was based on prior studies with 3% device malfunction and 0.9% failure-related conversion rates. The primary endpoint was the completion rate, defined as ≥95% without conversion due to system issues or major complications within 24 hours. The Full Analysis Set included all subjects who started the procedure. No interim analyses were planned.|Completion rate|97.5|||||TWO_SIDED|95.0|86.8|99.9||The study used descriptive statistics and confidence intervals, not hypothesis testing with p-values. The main goal was to confirm the completion rate met or exceeded 95% and present a 95% confidence interval||The main goal was to confirm the completion rate met or exceeded 95% with a 95% confidence interval.|Estimated Value of 97.5% is an overall completion rate|The study aimed to confirm the Medtronic Hugo™ RAS System's performance for prostatectomy or cholecystectomy, targeting a 95% completion rate (no conversion due to system issues or major complications within 24 hours). The Full Analysis Set (FAS) included all subjects starting the procedure. Descriptive statistics and 95% confidence intervals were used to assess primary and secondary endpoints, confirming safety and effectiveness.|Descriptive Analysis was used|99.9|86.8|
71713253|NCT05715827|142942648|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Overall Complication Rate|20.0|||||TWO_SIDED|95.0|9.1|35.6||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||35.6|9.1|
71713254|NCT05715827|142942649|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Major complication rate|5.0|||||TWO_SIDED|95.0|0.6|16.9||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||16.9|0.6|
71713255|NCT05715827|142942650|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Readmission rate|10.0|||||TWO_SIDED|95.0|2.8|23.7||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||23.7|2.8|
71713256|NCT05715827|142942651|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Reoperation rate|0.0|||||TWO_SIDED|||||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||||
71713257|NCT05715827|142942652|OTHER|Descriptive statistics will be used, presenting frequency, percentage, and 95% confidence intervals for each secondary endpoint: overall complication rate, major complication rate, readmission rate, reoperation rate, and Device Deficiencies (DD) rate through 30 days post-surgery. Secondary endpoints will be assessed overall and by surgery type (prostatectomy and cholecystectomy).|Device deficiency rate|32.5|||||TWO_SIDED|95.0|18.6|49.1||Descriptive statistics and estimated rates were used. P-values were not calculated for secondary endpoints.||||The secondary objective is to assess the short-term safety outcome of the Medtronic Hugo™ RAS System when used for prostatectomy or cholecystectomy. Overall complication rate through 30-day post-surgery: A proportion of subjects with any postoperative complication within 30-days post-surgery using the investigational device||49.1|18.6|
71713258|NCT03021486|142942714|OTHER|||||||0.71|||||||Wilcoxon Rank Sum Test|||||||0.71
71713259|NCT03021486|142942716|OTHER|||||||0.86|||||||Wilcoxon Rank Sum Test|||||||0.86
71713260|NCT03021486|142942717|OTHER|||||||0.12|||||||Two-tailed Fisher's exact test|||||||0.12
71713261|NCT03021486|142942718|OTHER|||||||0.007|||||||Two-tailed Fisher's exact test|||||||0.007
71713262|NCT03021486|142942719|OTHER|||||||0.83|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by caregiver||||0.83
71713263|NCT03021486|142942719|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by caregiver||||0.82
71713264|NCT03021486|142942720|OTHER|||||||0.82|||||||Two-tailed Fisher's exact test|||Perceived Comfort level as assessed by nurse||||0.82
71713265|NCT03021486|142942720|OTHER|||||||0.91|||||||Two-tailed Fisher's exact test|||Perceived agitation level as assessed by nurse||||0.91
71713266|NCT03021486|142942721|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - frequency||||0.12
71713267|NCT03021486|142942721|OTHER|||||||0.07|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - frequency||||0.07
71713268|NCT03021486|142942721|OTHER|||||||0.051|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - frequency||||0.051
71713269|NCT03021486|142942721|OTHER|||||||0.048|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - frequency||||0.048
71713270|NCT03021486|142942721|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - frequency||||0.15
71827836|NCT03254394|143159650|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.318|TWO_SIDED|95.0|-7.09|20.85||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Average AUC of cold pain score over 14 days of a chemotherapy cycle in the Control group is equal or lower than that of the experimental group. The comparison is for average AUC values over 7 cycles of chemotherapy per patient||20.85|-7.09|0.318
71827837|NCT03254394|143159650|SUPERIORITY||Mean Difference (Final Values)|7.67||||0.466|TWO_SIDED|95.0|-13.76|29.1||p-value was not adjusted for any parameter.|t-test, 2 sided|||Null hypothesis: Cold hypersensitivity counted as unpleasantness score for 14 days after cycle (AUC) in the Control group is less than that of the experimental group. The difference was calculated for the Cycle 6 visit.||29.10|-13.76|0.466
71827838|NCT03254394|143159651|SUPERIORITY||Median Difference (Final Values)|20.0||||0.338|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||the null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.338
71827839|NCT03254394|143159651|SUPERIORITY||Median Difference (Final Values)|2.0||||0.759|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is EORTC QLQ-CIPN20 sensory score change in the Control group is equal to or less than that of the experimental group for the cycle 6 (12 weeks) follow-up study visit.||||0.759
71827840|NCT03254394|143159652|SUPERIORITY||Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C3 (6 weeks) study visit.||||0.581
71827841|NCT03254394|143159652|SUPERIORITY||Median Difference (Final Values)|0.0||||0.962|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the C6 (12 weeks) study visit.||||0.962
71827842|NCT03254394|143159652|SUPERIORITY||Median Difference (Final Values)|10.5||||0.365|TWO_SIDED|||||p-value was not adjusted for any parameter.|Wilcoxon (Mann-Whitney)|||The null hypothesis is NPSI total score in the Control group is equal to or less than that of the experimental group for the last follow-up study visit.||||0.365
71656578|NCT01156142|142831176|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Chi-squared|||||||0.0018
71656579|NCT02337959|142831218|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.028
71656580|NCT02337959|142831219|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05|t-test, 1 sided|||Both the predicate and investigational images were randomized for the monitors. Predicate images could display on the left or the right and vice versa with the investigational. There were formulas in the spreadsheet that gave the preferences a numerical value, and subsequently became part of the analysis.||||0.000
71656581|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Overall comparison of treatment groups for incidence of ILI|Chi-squared|||||||0.25
71656582|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparision of ILI incidence in subjects age 50 and older at baseline.|Chi-squared|||||||0.01
71656583|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Comparison of ILI in subjects age \< 50 at baseline|Chi-squared|||||||0.32
71656584|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.|Chi-squared|||||||0.01
71656585|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment|Chi-squared|||||||0.45
71656586|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Comparison of ILI incidence in male subjects|Chi-squared|||||||0.03
71656587|NCT00895947|142831230|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Comparison of ILI incidence in female subjects|Chi-squared|||||||0.99
71656588|NCT00895947|142831231|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Proportion of subjects reporting any cold/flu symptoms during treatment|Chi-squared|||||||0.16
71656589|NCT00895947|142831231|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects reporting moderate to severe feverishness|Chi-squared|||||||0.03
71656590|NCT00895947|142831231|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Proportion of subjects reporting moderate to severe head congestion|Chi-squared|||||||0.04
71656591|NCT00895947|142831231|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Proportion of subjects reporting moderate to severe sore throat|Chi-squared|||||||0.07
71656592|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly|Chi-squared|||||||0.39
71656593|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well|Chi-squared|||||||0.15
71656594|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily|Chi-squared|||||||0.66
71827843|NCT03254394|143159653|SUPERIORITY||Mean Difference (Final Values)|57.68||||0.73|TWO_SIDED|95.0|-1771.0|1886.0|||t-test, 2 sided|||The null hypothesis is Oxaliplatin cumulative dose in the Control group is equal to or higher than that of the experimental group.||1886|-1771|0.730
71827844|NCT03360396|143159654|OTHER|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||||||||||||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.||Study was closed early in all regions except for France. SAP was updated to include descriptive statistics only. French sites remain open.||Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|Study was closed early in all regions except for France. Statistical Analysis plan was updated to include descriptive statistics only. Sites in France remain open and all subjects in France will be followed through 36 months.|||
71656595|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise|Chi-squared|||||||0.48
71713271|NCT03021486|142942721|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - frequency||||0.10
71713272|NCT03021486|142942721|OTHER|||||||0.15|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation- frequency||||0.15
71713273|NCT03021486|142942721|OTHER|||||||0.98|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to time - distress||||0.98
71713274|NCT03021486|142942721|OTHER|||||||0.93|||||||Wilcoxon Rank Sum Test|||Nursing assessment, disorientation to place - distress||||0.93
71713275|NCT03021486|142942721|OTHER|||||||0.08|||||||Wilcoxon Rank Sum Test|||Nursing assessment, visual hallucination - distress||||0.08
71713276|NCT03021486|142942721|OTHER|||||||0.28|||||||Wilcoxon Rank Sum Test|||Nursing assessment, tactile hallucination - distress||||0.28
71713277|NCT03021486|142942721|OTHER|||||||0.83|||||||Wilcoxon Rank Sum Test|||Nursing assessment, auditory hallucination - distress||||0.83
71713278|NCT03021486|142942721|OTHER|||||||0.22|||||||Wilcoxon Rank Sum Test|||Nursing assessment, delusional thoughts - distress||||0.22
71713279|NCT03021486|142942721|OTHER|||||||0.75|||||||Wilcoxon Rank Sum Test|||Nursing assessment, psychomotor agitation - distress||||0.75
71713280|NCT03021486|142942722|OTHER|||||||0.09|||||||Wilcoxon Rank Sum Test|||||||0.09
71713281|NCT03021486|142942723|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in pain.||||0.02
71713282|NCT03021486|142942723|OTHER|||||||0.1|||||||Wilcoxon Rank Sum Test|||Mean change in Fatigue.||||0.10
71713283|NCT03021486|142942723|OTHER|||||||0.02|||||||Wilcoxon Rank Sum Test|||Mean change in Nausea.||||0.02
71713284|NCT03021486|142942723|OTHER|||||||0.97|||||||Wilcoxon Rank Sum Test|||Mean change in Depression.||||0.97
71713285|NCT03021486|142942723|OTHER|||||||0.03|||||||Wilcoxon Rank Sum Test|||Mean change in Anxiety.||||0.03
71713286|NCT03021486|142942723|OTHER|||||||0.68|||||||Wilcoxon Rank Sum Test|||Mean change in Drowsiness.||||0.68
71656596|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities|Chi-squared|||||||0.26
71656597|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home|Chi-squared|||||||0.25
71656598|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home|Chi-squared|||||||0.20
71656599|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others|Chi-squared|||||||0.20
71656600|NCT00895947|142831232|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life|Chi-squared|||||||0.32
71713287|NCT03021486|142942723|OTHER|||||||0.8|||||||Wilcoxon Rank Sum Test|||Mean change in Appetite.||||0.80
71713288|NCT03021486|142942723|OTHER|||||||0.45|||||||Wilcoxon Rank Sum Test|||Mean change in Feeling of well being.||||0.45
71713289|NCT03021486|142942723|OTHER|||||||0.16|||||||Wilcoxon Rank Sum Test|||Mean change in Shortness of breath.||||0.16
71713290|NCT03021486|142942723|OTHER|||||||0.12|||||||Wilcoxon Rank Sum Test|||Mean change in Sleep.||||0.12
71713291|NCT04795531|142942725|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment, region and sulfonylureas (SU)/glinides use as fixed factors, and baseline response as covariate.||-0.08|-0.34|<0.0001
71713292|NCT04887831|142942736|OTHER||Adjusted percentage difference|-0.101|STANDARD_ERROR_OF_MEAN|0.1052||0.34|TWO_SIDED|95.0|-0.308|0.105||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.105|-0.308|0.340
71713293|NCT04887831|142942737|OTHER||Adjusted percentage difference|-0.008|STANDARD_ERROR_OF_MEAN|0.1078||0.938|TWO_SIDED|95.0|-0.22|0.203||The 2-sided p-value was calculated using stratified CMH method to account for the presence of visceral metastasis (yes/no) and initial chemotherapy type (cisplatin/carboplatin) as the stratification factors.|Cochran-Mantel-Haenszel|||||0.203|-0.220|0.938
71713294|NCT05093621|142942782|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Mortality at 1 year||||1.000
71713295|NCT05093621|142942783|SUPERIORITY|||||||0.729|||||||t-test, 2 sided|||||||0.729
71713296|NCT05093621|142942784|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.650
71713297|NCT05093621|142942785|SUPERIORITY|||||||0.873|||||||t-test, 2 sided|||||||0.873
71713298|NCT01198587|142942891|SUPERIORITY|||||||0.88|||||||Log Rank|||||||0.88
71713299|NCT01198587|142942891|SUPERIORITY|||||||0.19|||||||Log Rank|||||||0.19
71713300|NCT02008617|142942934|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71713301|NCT02008617|142942935|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||At Rest||||0.86
71713302|NCT02008617|142942935|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Plantar Flexion||||0.89
71713303|NCT02008617|142942936|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71713304|NCT02008617|142942937|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
71713305|NCT02958865|142943006|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.69||0.0017|TWO_SIDED|90.0|-3.17|-0.89|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-0.89|-3.17|0.0017
71766848|NCT03567343|143035871|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.9875|TWO_SIDED|95.0|-3.89|3.83|||Paired T-test|||||3.83|-3.89|0.9875
71766849|NCT03567343|143035871|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.2||||0.9463|TWO_SIDED|95.0|-6.23|5.82|||Paired T-test|||||5.82|-6.23|0.9463
71766850|NCT03567343|143035872|EQUIVALENCE|P\<0.05|Mean Difference (Net)|28.5||||0.0037|TWO_SIDED|95.0|9.84|47.17|||Paired T-test|||||47.17|9.84|0.0037
71827845|NCT03360396|143159655|OTHER|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||||||||||||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.||Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|Study was terminated early, and Statistical Analysis plan was updated to include descriptive statistics only.|||
71656601|NCT00895947|142831233|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Proportion of subjects in each group reporting one or more days they felt sick|Chi-squared|||||||0.66
71656602|NCT00895947|142831233|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Proportion of subjects in each group reporting one or more days they missed work|Chi-squared|||||||0.88
71656603|NCT00895947|142831233|SUPERIORITY_OR_OTHER|||||||1||95.0||||Proportion of subjects in each group reporting one or more days they visited the doctor|Chi-squared|||||||1.0
71656604|NCT00895947|142831233|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects in each group reporting one or more days they visited the pharmacy|Chi-squared|||||||0.54
71656605|NCT00895947|142831233|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||Proportion of subjects in each group reporting one or more days they took cold/flu medication|Chi-squared|||||||0.24
71656606|NCT00895947|142831233|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||Proportion of subjects in each group reporting one or more days they skipped a planned activity|Chi-squared|||||||0.89
71656607|NCT00895947|142831234|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Proportion of subjects in each group with a confirmed viral respiratory infection|Chi-squared|||||||0.61
71656608|NCT00895947|142831234|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection|Chi-squared|||||||0.003
71656609|NCT00895947|142831234|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe influenza infection|Chi-squared|||||||0.03
71656610|NCT00895947|142831234|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza|Chi-squared|||||||0.03
71656611|NCT00895947|142831235|SUPERIORITY_OR_OTHER|||||||0.54||95.0||||Proportion of subjects meeting the definition of acute respiratory illness during treatment|Chi-squared|||||||0.54
71656612|NCT00895947|142831235|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment|Chi-squared|||||||0.06
71656613|NCT00895947|142831235|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment|Chi-squared|||||||0.03
71656614|NCT00895947|142831235|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment|Chi-squared|||||||0.60
71656615|NCT05472662|142831236|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|1.86||||0.113|TWO_SIDED|95.0|-0.48|4.2|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||4.20|-0.48|0.113
71656616|NCT05472662|142831237|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.58||||0.483|TWO_SIDED|95.0|-1.1|2.25|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||2.25|-1.10|0.483
71656617|NCT05472662|142831237|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|0.23||||0.782|TWO_SIDED|95.0|-1.45|1.9|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.90|-1.45|0.782
71656618|NCT05472662|142831237|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.4||||0.599|TWO_SIDED|95.0|-1.97|1.16|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||1.16|-1.97|0.599
71656619|NCT05472662|142831237|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.13||||0.815|TWO_SIDED|95.0|-1.24|0.99|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.99|-1.24|0.815
71766851|NCT03567343|143035872|EQUIVALENCE|p\<0.05|Mean Difference (Net)|9.84||||0.4395|TWO_SIDED|95.0|-15.63|35.31|||Paired T-test|||||35.31|-15.63|0.4395
71766852|NCT03567343|143035873|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.03||||0.912|TWO_SIDED|95.0|-0.59|0.53|||Paired T-test|||||0.53|-0.59|0.912
71766853|NCT03567343|143035873|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.11||||0.8207|TWO_SIDED|95.0|-1.04|0.83|||Paired T-test|||||0.83|-1.04|.8207
71766854|NCT03567343|143035874|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.89||||0.1929|TWO_SIDED|95.0|-2.26|0.47|||Paired T-test|||||0.47|-2.26|0.1929
71766855|NCT03567343|143035874|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.24||||0.8744|TWO_SIDED|95.0|-3.35|2.86|||Paired T-test|||||2.86|-3.35|0.8744
71766856|NCT03567343|143035875|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.95||||0.2048|TWO_SIDED|95.0|-2.45|0.54|||Paired T-test|||||0.54|-2.45|0.2048
71766857|NCT03567343|143035875|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.96||||0.1933|TWO_SIDED|95.0|-0.5|2.42|||Paired T-test|||||2.42|-0.5|0.1933
71713306|NCT02958865|142943006|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-5.01|-2.74|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.74|-5.01|< 0.0001
71713307|NCT02958865|142943006|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|90.0|-5.76|-3.46|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-3.46|-5.76|< 0.0001
71713308|NCT02958865|142943006|SUPERIORITY||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.68||0.0045|TWO_SIDED|90.0|-2.92|-0.67|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.||-0.67|-2.92|0.0045
71713309|NCT02958865|142943006|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.69||0.0005|TWO_SIDED|90.0|-3.41|-1.14|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-1.14|-3.41|0.0005
71713310|NCT02958865|142943006|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|90.0|-4.34|-2.08|||Constrained Longitudinal Data Analysis|||The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.||-2.08|-4.34|< 0.0001
71713311|NCT02958865|142943023|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.0626|TWO_SIDED|90.0|-1.0|19.5|||Chan and Zhang method|||||19.5|-1.0|0.0626
71713312|NCT02958865|142943023|SUPERIORITY||Mean Difference (Final Values)|28.6||||0.0027|TWO_SIDED|90.0|13.9|41.0|||Chan and Zhang method|||||41.0|13.9|0.0027
71713313|NCT02958865|142943023|SUPERIORITY||Mean Difference (Final Values)|34.0||||0.001|TWO_SIDED|90.0|20.2|46.5|||Chan and Zhang Method|||||46.5|20.2|0.0010
71713314|NCT02958865|142943023|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0774|TWO_SIDED|90.0|-4.0|18.1|||Chan and Zhang method|||||18.1|-4.0|0.0774
71766858|NCT03567343|143035876|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-1.69||||0.034|TWO_SIDED|95.0|-3.25|-0.13|||Paired T-test|||change in mean number of lapses||-0.13|-3.25|0.034
71766859|NCT03567343|143035876|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.41||||0.5242|TWO_SIDED|95.0|-0.88|1.71|||Paired T-test|||Change in number of lapses||1.71|-0.88|0.5242
71766860|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.67||||0.8106|TWO_SIDED|95.0|-4.92|6.25|||Paired T-test|||POMS-TMD||6.25|-4.92|0.8106
71766861|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|3.87||||0.1427|TWO_SIDED|95.0|-1.35|9.09|||Paired T-test|||POMS-TMD||9.09|-1.35|0.1427
71766862|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9344|TWO_SIDED|95.0|-1.11|1.21|||Paired T-test|||POMS-Tension||1.21|-1.11|0.9344
71766863|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.54||||0.0092|TWO_SIDED|95.0|0.4|2.69|||Paired T-test|||POMS-Tension||2.69|0.40|0.0092
71766864|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.29||||0.755|TWO_SIDED|95.0|-1.55|2.12|||Paired T-test|||POMS-Depression||2.12|-1.55|0.755
71766865|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.74||||0.2131|TWO_SIDED|95.0|-0.44|1.92|||Paired T-test|||POMS-Depression||1.92|-0.44|0.2131
71766866|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.19||||0.06|TWO_SIDED|95.0|-0.05|2.43|||Paired T-test|||POMS-Anger||2.43|-0.05|0.06
71766867|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.24||||0.4117|TWO_SIDED|95.0|-0.34|0.82|||Paired T-test|||POMS-Anger||0.82|-0.34|0.4117
71766868|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.05||||0.9548|TWO_SIDED|95.0|-1.64|1.73|||Paired T-test|||POMS-Fatigue||1.73|-1.64|0.9548
71766869|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.48||||0.4649|TWO_SIDED|95.0|-0.83|1.79|||Paired T-test|||POMS-Fatigue||1.79|-0.83|0.4649
71766870|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.26||||0.5656|TWO_SIDED|95.0|-0.65|1.18|||Paired T-test|||POMS-Confusion||1.18|-0.65|0.5656
71766871|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.33||||0.4307|TWO_SIDED|95.0|-0.5|1.15|||Paired T-test|||POMS-Confusion||1.15|-0.5|0.4307
71766872|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.17||||0.2651|TWO_SIDED|95.0|-0.92|3.25|||Paired T-test|||POMS-Vigor||3.25|-0.92|0.2651
71766873|NCT03567343|143035877|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.54||||0.5992|TWO_SIDED|95.0|-2.61|1.53|||Paired T-test|||POMS-Vigor||1.53|-2.61|0.5992
71766874|NCT03567343|143035878|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.37||||0.6869|TWO_SIDED|95.0|-1.48|2.22|||Paired T-test|||||2.22|-1.48|0.6869
71766875|NCT03567343|143035878|EQUIVALENCE|P\<0.05|Mean Difference (Net)|1.39||||0.1769|TWO_SIDED|95.0|-0.65|3.43|||Paired T-test|||||3.43|-0.65|0.1769
71766876|NCT03567343|143035879|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.51||||0.6422|TWO_SIDED|95.0|-1.69|2.72|||Paired T-test|||||2.72|-1.69|0.6422
71766877|NCT03567343|143035879|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.63||||0.4106|TWO_SIDED|95.0|-0.9|2.16|||Paired T-test|||||2.16|-0.9|0.4106
71766878|NCT03567343|143035880|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-0.23||||0.5672|TWO_SIDED|95.0|-1.05|0.58|||Paired T-test|||||0.58|-1.05|0.5672
71766879|NCT03567343|143035880|EQUIVALENCE|P\<0.05|Mean Difference (Net)|0.11||||0.805|TWO_SIDED|95.0|-0.77|0.99|||Paired T-test|||||0.99|-0.77|0.805
71766880|NCT03567343|143035881|EQUIVALENCE|P\<0.05|Median Difference (Net)|-43.09||||0.1236|TWO_SIDED|95.0|-98.43|12.26|||Paired T-test|||Change in lapse time||12.26|-98.43|.1236
71766881|NCT03567343|143035881|EQUIVALENCE|P\<0.05|Mean Difference (Net)|-2.01||||0.8241|TWO_SIDED|95.0|-20.13|16.11|||Paired T-test|||Change in lapse time||16.11|-20.13|.8241
71827846|NCT01123083|143159758|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.051|TWO_SIDED|95.0|-0.17|0.0|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|||0.00|-0.17|0.051
71713315|NCT02958865|142943023|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
71713316|NCT02958865|142943023|SUPERIORITY||Mean Difference (Final Values)|23.4||||0.0055|TWO_SIDED|90.0|8.2|35.8|||Chan and Zhang method|||||35.8|8.2|0.0055
71713317|NCT02958865|142943024|SUPERIORITY||Mean Difference (Final Values)|21.6||||0.0111|TWO_SIDED|90.0|5.6|33.2|||Chan and Zhang method|||||33.2|5.6|0.0111
71713318|NCT02958865|142943024|SUPERIORITY||Mean Difference (Final Values)|34.7||||0.0006|TWO_SIDED|90.0|20.2|47.4|||Chan and Zhang method|||||47.4|20.2|0.0006
71713319|NCT02958865|142943024|SUPERIORITY||Mean Difference (Final Values)|42.0||||0.0001|TWO_SIDED|90.0|29.5|54.6|||Chan and Zhang Method|||||54.6|29.5|0.0001
71713320|NCT02958865|142943024|SUPERIORITY||Mean Difference (Final Values)|20.8||||0.0101|TWO_SIDED|90.0|5.6|33.0|||Chan and Zhang method|||||33.0|5.6|0.0101
71713321|NCT02958865|142943024|SUPERIORITY||Mean Difference (Final Values)|31.9||||0.0014|TWO_SIDED|90.0|17.0|44.8|||Chan and Zhang method|||||44.8|17.0|0.0014
71713322|NCT02958865|142943024|SUPERIORITY||Mean Difference (Final Values)|29.8||||0.0015|TWO_SIDED|90.0|17.0|42.6|||Chan and Zhang method|||||42.6|17.0|0.0015
71713323|NCT02958865|142943025|SUPERIORITY||Mean Difference (Final Values)|17.2||||0.0788|TWO_SIDED|90.0|-3.4|34.4|||Chan and Zhang method|||||34.4|-3.4|0.0788
71713324|NCT02958865|142943025|SUPERIORITY||Mean Difference (Final Values)|45.4||||0.0002|TWO_SIDED|90.0|23.6|62.1|||Chan and Zhang method|||||62.1|23.6|0.0002
71713325|NCT02958865|142943025|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.0003|TWO_SIDED|90.0|23.5|60.5|||Chan and Zhang Method|||||60.5|23.5|0.0003
71713326|NCT02958865|142943025|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.0773|TWO_SIDED|90.0|-4.0|35.1|||Chan and Zhang method|||||35.1|-4.0|0.0773
71713327|NCT02958865|142943025|SUPERIORITY||Mean Difference (Final Values)|29.2||||0.0136|TWO_SIDED|90.0|5.6|47.0|||Chan and Zhang method|||||47.0|5.6|0.0136
71827847|NCT01123083|143159759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.022|TWO_SIDED|95.0|-0.18|-0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Week 12||-0.02|-0.18|0.022
71713328|NCT02958865|142943025|SUPERIORITY||Mean Difference (Final Values)|37.7||||0.0015|TWO_SIDED|90.0|13.9|54.7|||Chan and Zhang method|||||54.7|13.9|0.0015
71713329|NCT02958865|142943026|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
71713330|NCT02958865|142943026|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
71713331|NCT02958865|142943026|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
71713332|NCT02958865|142943026|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3777|TWO_SIDED|90.0|-8.6|9.7|||Chan and Zhang method|||||9.7|-8.6|0.3777
71713333|NCT02958865|142943026|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.0212|TWO_SIDED|90.0|2.9|28.6|||Chan and Zhang method|||||28.6|2.9|0.0212
71713334|NCT02958865|142943026|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0742|TWO_SIDED|90.0|-4.2|18.4|||Chan and Zhang method|||||18.4|-4.2|0.0742
71713335|NCT02958865|142943027|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.0872|TWO_SIDED|90.0|-3.4|17.1|||Chan and Zhang method|||||17.1|-3.4|0.0872
71713336|NCT02958865|142943027|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.0254|TWO_SIDED|90.0|3.0|27.5|||Chan and Zhang method|||||27.5|3.0|0.0254
71713337|NCT02958865|142943027|SUPERIORITY||Mean Difference (Final Values)|26.0||||0.0034|TWO_SIDED|90.0|11.0|38.1|||Chan and Zhang Method|||||38.1|11.0|0.0034
71713338|NCT02958865|142943027|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.1565|TWO_SIDED|90.0|-4.5|15.4|||Chan and Zhang method|||||15.4|-4.5|0.1565
71713339|NCT02958865|142943027|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
71713340|NCT02958865|142943027|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
71713341|NCT02958865|142943028|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.2259|TWO_SIDED|90.0|-6.5|11.8|||Chan and Zhang method|||||11.8|-6.5|0.2259
71713342|NCT02958865|142943028|SUPERIORITY||Mean Difference (Final Values)|8.2||||0.082|TWO_SIDED|90.0|-3.8|17.7|||Chan and Zhang method|||||17.7|-3.8|0.0820
71713343|NCT02958865|142943028|SUPERIORITY||Mean Difference (Final Values)|12.0||||0.0649|TWO_SIDED|90.0|-0.7|22.3|||Chan and Zhang Method|||||22.3|-0.7|0.0649
71766882|NCT03259620|143035933|SUPERIORITY|||||||0.2587|||||||Cochran-Mantel-Haenszel|||||||0.2587
71766883|NCT00827931|143035938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-99.9|STANDARD_ERROR_OF_MEAN|131.99||0.46|TWO_SIDED|95.0|-371.4|171.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||171.5|-371.4|0.460
71827848|NCT01123083|143159759|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.191|TWO_SIDED|95.0|-0.15|0.03|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.03|-0.15|0.191
71827849|NCT01123083|143159761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.912|TWO_SIDED|95.0|0.5|3.37|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Week 12||3.37|0.50|0.912
71827850|NCT01123083|143159761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.912|TWO_SIDED|95.0|0.37|2.42|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 6||2.42|0.37|0.912
71656620|NCT05472662|142831237|EQUIVALENCE|Equivalence was demonstrated if the 95% CI of the adjusted mean difference in relative change from baseline in FEV1 between HFA-152a and HFA-134a was within the equivalence limits \[-10% ; +10%\].|Adjusted mean difference|-0.69||||0.294|TWO_SIDED|95.0|-2.01|0.64|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject, and period as fixed effects and FEV1 baseline as covariate."||0.64|-2.01|0.294
71713344|NCT02958865|142943028|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-11.3|6.1|||Chan and Zhang method|||||6.1|-11.3|1.0000
71713345|NCT02958865|142943028|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.0288|TWO_SIDED|90.0|1.7|26.2|||Chan and Zhang method|||||26.2|1.7|0.0288
71713346|NCT02958865|142943028|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.1593|TWO_SIDED|90.0|-4.4|15.7|||Chan and Zhang method|||||15.7|-4.4|0.1593
71713347|NCT02329587|142943061|OTHER||Between-group effect size (Hedge's g)|0.138|||||TWO_SIDED|||||||||||||
71713348|NCT02329587|142943062|OTHER||Between-group effect size (Hedge's g)|-0.214|||||TWO_SIDED|||||||||||||
71713349|NCT02329587|142943063|OTHER||Between-groups effect size (Hedge's g)|-0.007|||||TWO_SIDED|||||||||||||
71656621|NCT05472662|142831238|OTHER||Adjusted mean difference|0.015||||0.519|TWO_SIDED|95.0|-0.032|0.061|||ANCOVA|||"Statistical analysis performed on the data at 5 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.061|-0.032|0.519
71656622|NCT05472662|142831238|OTHER||Adjusted mean difference|0.061||||0.085|TWO_SIDED|95.0|-0.009|0.13|||ANCOVA|||"Statistical analysis performed on the data at 15 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.130|-0.009|0.085
71656623|NCT05472662|142831238|OTHER||Adjusted mean difference|0.004||||0.858|TWO_SIDED|95.0|-0.045|0.054|||ANCOVA|||"Statistical analysis performed on the data at 30 min post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.054|-0.045|0.858
71713350|NCT02329587|142943064|OTHER||Between-group effect size (Hedge's g)|-0.151|||||TWO_SIDED|||||||||||||
71656624|NCT05472662|142831238|OTHER||Adjusted mean difference|-0.011||||0.632|TWO_SIDED|95.0|-0.058|0.036|||ANCOVA|||"Statistical analysis performed on the data at 1 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.036|-0.058|0.632
71656625|NCT05472662|142831238|OTHER||Adjusted mean difference|-0.003||||0.846|TWO_SIDED|95.0|-0.038|0.031|||ANCOVA|||"Statistical analysis performed on the data at 1.5 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.031|-0.038|0.846
71713351|NCT02329587|142943065|OTHER||Between-groups effect size (Hedge's g)|0.704|||||TWO_SIDED|||||||||||||
71713352|NCT02329587|142943066|OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED|||||||||||||
71713353|NCT01380080|142943104|SUPERIORITY_OR_OTHER_LEGACY||Cumulative probability difference|-0.06||||0.97|TWO_SIDED|95.0|-3.05|2.94|||z-test|||Treatment comparison was made using the difference (arm B- arm A) in the Kaplan-Meier estimate for 24 week cumulative probability of death or unknown vital status with 95% confidence interval||2.94|-3.05|0.97
71713354|NCT06378008|142943125|SUPERIORITY||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.98|-1.62|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||-1.62|-1.98|<0.0001
71713355|NCT06378008|142943126|SUPERIORITY||Adjusted Mean Difference|52.87|STANDARD_ERROR_OF_MEAN|2.428|<|0.0001|TWO_SIDED|95.0|48.08|57.65|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 56||57.65|48.08|<0.0001
71713356|NCT06378008|142943127|SUPERIORITY||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||-0.08|-0.29|0.0005
71713357|NCT06378008|142943127|SUPERIORITY||Adjusted Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.73|-0.49|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||-0.49|-0.73|<0.0001
71713358|NCT06378008|142943127|SUPERIORITY||Adjusted Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-1.41|-1.04|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||-1.04|-1.41|<0.0001
71713359|NCT06378008|142943127|SUPERIORITY||Adjusted Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.74|-1.38|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||-1.38|-1.74|<0.0001
71713360|NCT06378008|142943128|SUPERIORITY||Adjusted Mean Difference|7.14|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|5.75|8.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 3||8.53|5.75|<0.0001
71713361|NCT06378008|142943128|SUPERIORITY||Adjusted Mean Difference|14.4|STANDARD_ERROR_OF_MEAN|1.112|<|0.0001|TWO_SIDED|95.0|12.2|16.59|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 7||16.59|12.20|<0.0001
71713362|NCT06378008|142943128|SUPERIORITY||Adjusted Mean Difference|25.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|22.67|28.93|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 14||28.93|22.67|<0.0001
71827851|NCT01123083|143159761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.412|TWO_SIDED|95.0|0.54|4.52|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 12||4.52|0.54|0.412
71713363|NCT06378008|142943128|SUPERIORITY||Adjusted Mean Difference|40.99|STANDARD_ERROR_OF_MEAN|2.254|<|0.0001|TWO_SIDED|95.0|36.55|45.43|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test toothpaste minus reference toothpaste.|Change from Baseline at Day 28||45.43|36.55|<0.0001
71713364|NCT06378008|142943129|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.219||0.3489|TWO_SIDED|95.0|-0.64|0.23|||Mixed Model with Repeated Measures||Adjusted Mean Difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.23|-0.64|0.3489
71713365|NCT06378008|142943129|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.267||0.0876|TWO_SIDED|95.0|-0.98|0.07|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.07|-0.98|0.0876
71713366|NCT06378008|142943129|SUPERIORITY||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.252||0.9108|TWO_SIDED|95.0|-0.47|0.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.52|-0.47|0.9108
71713367|NCT06378008|142943129|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.281||0.4854|TWO_SIDED|95.0|-0.75|0.36|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.36|-0.75|0.4854
71713368|NCT06378008|142943129|SUPERIORITY||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.261||0.8309|TWO_SIDED|95.0|-0.46|0.57|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.57|-0.46|0.8309
71713369|NCT06378008|142943129|SUPERIORITY||Adjusted Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.297||0.05|TWO_SIDED|95.0|-1.17|0.0|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||-0.00|-1.17|0.0500
71713370|NCT06378008|142943130|SUPERIORITY||Adjusted Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|3.859||0.5565|TWO_SIDED|95.0|-9.88|5.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||5.33|-9.88|0.5565
71713371|NCT06378008|142943130|SUPERIORITY||Adjusted Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|4.715||0.2078|TWO_SIDED|95.0|-15.25|3.34|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||3.34|-15.25|0.2078
71713372|NCT06378008|142943131|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.588||0.5597|TWO_SIDED|95.0|-1.5|0.82|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.82|-1.50|0.5597
71713373|NCT06378008|142943131|SUPERIORITY||Adjusted Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.705||0.4627|TWO_SIDED|95.0|-1.91|0.87|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.87|-1.91|0.4627
71713374|NCT06378008|142943132|SUPERIORITY||Adjusted Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|1.583||0.3|TWO_SIDED|95.0|-4.77|1.48|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.48|-4.77|0.3000
71713375|NCT06378008|142943132|SUPERIORITY||Adjusted Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.958||0.1974|TWO_SIDED|95.0|-6.39|1.33|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.33|-6.39|0.1974
71713376|NCT06378008|142943133|SUPERIORITY||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.679||0.9203|TWO_SIDED|95.0|-1.27|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.27|0.9203
71713377|NCT06378008|142943133|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.717||0.2489|TWO_SIDED|95.0|-2.24|0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.58|-2.24|0.2489
71713378|NCT06378008|142943134|SUPERIORITY||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|1.09||0.8496|TWO_SIDED|95.0|-2.36|1.94|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.94|-2.36|0.8496
71713379|NCT06378008|142943134|SUPERIORITY||Adjusted Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|1.226||0.1596|TWO_SIDED|95.0|-4.15|0.69|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.69|-4.15|0.1596
71713380|NCT06378008|142943135|SUPERIORITY||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.697||0.9577|TWO_SIDED|95.0|-1.34|1.41|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||1.41|-1.34|0.9577
71713381|NCT06378008|142943135|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.748||0.8261|TWO_SIDED|95.0|-1.64|1.31|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||1.31|-1.64|0.8261
71713382|NCT06378008|142943136|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.8895|TWO_SIDED|95.0|-0.19|0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.16|-0.19|0.8895
71827852|NCT01123083|143159762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.21|TWO_SIDED|95.0|-0.08|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.02|-0.08|0.210
71827853|NCT01123083|143159762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.21|TWO_SIDED|95.0|-0.11|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.02|-0.11|0.210
71827854|NCT01123083|143159762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.402|TWO_SIDED|95.0|-0.05|0.13|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.13|-0.05|0.402
71827855|NCT01123083|143159763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.582|TWO_SIDED|95.0|-0.52|0.16|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Week 12||0.16|-0.52|0.582
71827856|NCT01123083|143159763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.46|0.45|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 6||0.45|-0.46|0.987
71827857|NCT01123083|143159763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.572|TWO_SIDED|95.0|-0.33|0.59|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 12||0.59|-0.33|0.572
71827858|NCT01123083|143159766|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 6||||0.452
71827859|NCT01123083|143159766|SUPERIORITY_OR_OTHER|||||||0.452|||||||Hochberg-adjusted p-value|||Month 12||||0.452
71827860|NCT01123083|143159767|SUPERIORITY_OR_OTHER|||||||0.123|||||||Hochberg-adjusted p-value|||Month 6||||0.123
71827861|NCT01123083|143159767|SUPERIORITY_OR_OTHER|||||||0.373|||||||Hochberg-adjusted p-value|||Month 12||||0.373
71827862|NCT03418324|143159768|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7|||||Estimated values reflects the percentage of participants with overall clinical benefit.|For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
71827863|NCT03418324|143159768|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||Estimated values reflects the percentage of participants with overall clinical benefit|For this study, we are not comparing outcome measures between the two groups.||95.7|22.3|
71656626|NCT05472662|142831238|OTHER||Adjusted mean difference|-0.024||||0.282|TWO_SIDED|95.0|-0.068|0.021|||ANCOVA|||"Statistical analysis performed on the data at 3 h post-dose timepoint.~Statistical analysis was performed by means of Analysis of Covariance (ANCOVA) model including treatment group, subject and period as fixed effects and FEV1 baseline as covariate."|Assess differences between treatment groups.|0.021|-0.068|0.282
71656627|NCT04620135|142831250|SUPERIORITY||The least squares (LS) mean difference|-1.74|STANDARD_ERROR_OF_MEAN|0.221|<|1e-05|TWO_SIDED|95.0|-2.17|-1.31||Analyzed as ANCOVA with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with MCMC and regression-based multiple imputation to impute missing data.|ANCOVA||||The primary analysis of the primary endpoint employed an analysis of covariance (ANCOVA) with mean diurnal IOP at Week 4 as the response, baseline mean diurnal IOP as a covariate, and treatment as a main effect, using the ITT population with Markov Chain Monte Carlo (MCMC) and regression based multiple imputation (MI) techniques to impute missing data. The least squares (LS) mean difference (netarsudil - ripasudil) was presented with a 2-sided p-value and 95% confidence intervals (CIs). A success criterion for the superiority of netarsudil to ripasudil was defined as the 2-sided p value ≤ 0.05 for testing the difference (netarsudil QD - ripasudil BID) to 0 and the point estimate of the LS mean difference of \< 0.|-1.31|-2.17|<0.00001
71656628|NCT04988152|142831253|SUPERIORITY||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
71656629|NCT04988152|142831254|OTHER||Ratio of geometric least squares means|1.0513|||||TWO_SIDED|90.0|0.9281|1.1908|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||1.1908|0.9281|
71827864|NCT03418324|143159771|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms||98.7|1.3|
71656630|NCT04988152|142831257|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
71827865|NCT03418324|143159771|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|66.7|||||TWO_SIDED|95.0|22.3|95.7||||||For this study, we are not comparing outcome measures between the two arms.||95.7|22.3|
71827866|NCT03418324|143159772|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|1.3|98.7||||||For this study, we are not comparing outcome measures between the two arms.||98.7|1.3|
71827867|NCT03418324|143159772|OTHER|Binomial proportion (Clopper-Pearson exact confidence interval) for each arm.|Binomial proportion|50.0|||||TWO_SIDED|95.0|11.8|88.2||||||For this study, we are not comparing outcome measures between the two arms.||88.2|11.8|
71827868|NCT01867580|143159796|SUPERIORITY|||||||0.677|||||||Regression, Logistic|||||||0.6770
71827869|NCT01867580|143159797|SUPERIORITY|||||||0.0202|||||||Wilcoxon (Mann-Whitney)|||||||0.0202
71827870|NCT01867580|143159798|SUPERIORITY|||||||0.0142|||||||Regression, Logistic|||||||0.0142
71827871|NCT03425643|143159802|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|1e-05|TWO_SIDED|95.0|0.48|0.72||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.72|0.48|<0.00001
71713383|NCT06378008|142943136|SUPERIORITY||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.101||0.8083|TWO_SIDED|95.0|-0.17|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.22|-0.17|0.8083
71713384|NCT06378008|142943137|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.351||0.7362|TWO_SIDED|95.0|-0.57|0.81|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 28||0.81|-0.57|0.7362
71713385|NCT06378008|142943137|SUPERIORITY||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.39||0.5568|TWO_SIDED|95.0|-1.0|0.54|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test Toothpaste minus Reference Toothpaste.|Change from Baseline at Day 56||0.54|-1.00|0.5568
71713386|NCT00210132|142943138|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of proportions.||||0.99
71713387|NCT00210132|142943139|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71713388|NCT00432965|142943140|SUPERIORITY||Odds Ratio (OR)|1.89||||0.007|TWO_SIDED|95.0|1.19|3.02|||Fisher Exact|||Time Frame: Days 0-114||3.02|1.19|0.007
71713389|NCT04532749|142943144|SUPERIORITY||Least square (LS) mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.43|=|0.411|TWO_SIDED|95.0|-4.0|1.64|||Mixed Model Repeated Measures (MMRM)|||||1.64|-4.00|=0.411
71713390|NCT04532749|142943145|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.27|=|0.473|TWO_SIDED|95.0|-3.41|1.59|||MMRM model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the first secondary endpoint (MADRS-WOSI) and thus, a formal statistical testing was not performed.||1.59|-3.41|=0.473
71713391|NCT04532749|142943146|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.45|=|0.167|TWO_SIDED|95.0|-4.87|0.85|||MMRM Model|||In accordance with protocol predefined testing sequence, statistical significance of the primary endpoint was required before testing the second secondary endpoint (PROMIS-SD; Short Form 8a) and thus, a formal statistical testing was not performed.||0.85|-4.87|=0.167
71713392|NCT01230411|142943154|SUPERIORITY||Odds Ratio (OR)|3.12||||0.078|TWO_SIDED|95.0|0.88|11.0|||Regression, Logistic|||||11.0|0.88|0.078
71713393|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|0.1||||0.1524|TWO_SIDED|95.0|-0.04|0.23|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.23|-0.04|0.1524
71713394|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|0.03||||0.7086|TWO_SIDED|95.0|-0.11|0.16|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.16|-0.11|0.7086
71713395|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|-0.13||||0.0651|TWO_SIDED|95.0|-0.26|0.01|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.01|-0.26|0.0651
71713396|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|0.02||||0.7937|TWO_SIDED|95.0|-0.12|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.12|0.7937
71713397|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|-0.04||||0.5587|TWO_SIDED|95.0|-0.18|0.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.10|-0.18|0.5587
71766884|NCT00827931|143035939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.6|STANDARD_ERROR_OF_MEAN|147.61||0.579|TWO_SIDED|95.0|-386.5|219.3|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||219.3|-386.5|0.579
71713398|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|-0.02||||0.7285|TWO_SIDED|95.0|-0.13|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.09|-0.13|0.7285
71713399|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|0.03||||0.5802|TWO_SIDED|95.0|-0.09|0.15|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|||0.15|-0.09|0.5802
71713400|NCT02255435|142943162|SUPERIORITY||LS Mean difference (Net)|0.0||||0.9698|TWO_SIDED|95.0|-0.08|0.08|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.08|-0.08|0.9698
71713401|NCT02255435|142943163|SUPERIORITY||LS Mean difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|0.956||0.0141|TWO_SIDED|95.0|-4.31|-0.5|||Mixed Models Analysis|Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS|Difference is omaveloxolone - placebo.|||-0.50|-4.31|0.0141
71713402|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-1.81||||0.231|TWO_SIDED|95.0|-4.8|1.18|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.18|-4.80|0.2310
71713403|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-0.52||||0.7298|TWO_SIDED|95.0|-3.51|2.47|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.47|-3.51|0.7298
71713404|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-0.99||||0.5102|TWO_SIDED|95.0|-3.99|2.0|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.00|-3.99|0.5102
71713405|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-0.95||||0.5281|TWO_SIDED|95.0|-3.94|2.04|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||2.04|-3.94|0.5281
71713406|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-1.42||||0.3458|TWO_SIDED|95.0|-4.42|1.57|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||1.57|-4.42|0.3458
71713407|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-2.3||||0.0587|TWO_SIDED|95.0|-4.68|0.09|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||0.09|-4.68|0.0587
71713408|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|0.58||||0.648|TWO_SIDED|95.0|-1.94|3.1|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|||3.10|-1.94|0.6480
71713409|NCT02255435|142943164|SUPERIORITY||LS Mean difference (Net)|-1.1||||0.2174|TWO_SIDED|95.0|-2.87|0.66|||Mixed Models Analysis|Treatment group, time, and the interaction between treatment and time were used as fixed factors.|Difference is omaveloxolone - placebo.|Comparison of Omaveloxolone capsules pooled with Placebo capsules||0.66|-2.87|0.2174
71713410|NCT01664624|142943189|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|5.82||0.388|TWO_SIDED|95.0|-16.9|6.7||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and alogliptin alone.||6.7|-16.9|0.388
71713411|NCT01664624|142943189|SUPERIORITY_OR_OTHER||LS Mean Difference|22.7|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|11.1|34.3||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||34.3|11.1|<0.001
71713412|NCT01664624|142943189|SUPERIORITY_OR_OTHER||LS Mean Difference|28.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|17.1|40.5||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.||40.5|17.1|<0.001
71713413|NCT00127439|142943195|NON_INFERIORITY_OR_EQUIVALENCE|The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.||||||0.05|||||||t-test, 2 sided|||||||0.05
71713414|NCT00127439|142943195|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon rank sum test|||Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)||||0.05
71713415|NCT00127439|142943196|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71713416|NCT00127439|142943197|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
71713417|NCT00127439|142943198|NON_INFERIORITY_OR_EQUIVALENCE|Provided previously||||||0.05|||||||t-test, 2 sided|||||||0.05
71713418|NCT00127439|142943199|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71713419|NCT00127439|142943200|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71713420|NCT00127439|142943201|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71713421|NCT00127439|142943202|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71766885|NCT00827931|143035940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.5|STANDARD_ERROR_OF_MEAN|239.19||0.452|TWO_SIDED|95.0|-672.6|305.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||305.5|-672.6|0.452
71713422|NCT00127439|142943203|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.05|||||||t-test, 2 sided|||||||0.05
71713423|NCT04067011|142943219|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9764|||||TWO_SIDED|90.0|0.8895|1.0718||||||Analysis of Geometric mean ratio of area under the curve from 0 to 12 hours (AUC0-12h) for ciprofloxacin on Days 8 and 35||1.0718|0.8895|
71713424|NCT04067011|142943219|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.9706|||||TWO_SIDED|90.0|0.8693|1.0838||||||Analysis of Geometric mean ration of Cmax for ciprofloxacin on Days 8 and 35||1.0838|0.8693|
71713425|NCT04067011|142943220|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of AUC0-12h.|Ratio of AUC|0.9173|||||TWO_SIDED|90.0|0.8187|1.0278||||||Analysis of Geometric mean ratio of Area under the curve from 0 to 12 hours (AUC0-12h) for doxycycline on Days 8 and 38||1.0278|0.8187|
71713426|NCT04067011|142943220|EQUIVALENCE|The equivalence testing was constructed using paired two one-sided t-tests (TOST) with natural log transformation of PK parameters. Results obtained from transformed analyses were back-transformed by exponentiation for presentation of the point estimates and 90% CIs for geometric mean ratio of Cmax.|Ratio of Cmax|0.8974|||||TWO_SIDED|90.0|0.7841|1.0271||||||Analysis of Geometric mean ration of Cmax for doxycycline on Days 8 and 38||1.0271|0.7841|
71713427|NCT04067011|142943221|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 1/Group 3)|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
71713428|NCT04067011|142943221|NON_INFERIORITY|Non-inferiority margin is 0.5.|Ratio of GMT (Group 2/Group 3)|1.14|||||TWO_SIDED|95.0|0.81|1.6||||||||1.6|0.81|
71766886|NCT00827931|143035941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-417.7|STANDARD_ERROR_OF_MEAN|152.51||0.01|TWO_SIDED|95.0|-729.4|-106.1|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.||-106.1|-729.4|0.010
71766887|NCT00827931|143035942|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used at 5% level of significance.||||0.701
71766888|NCT04157673|143035956|SUPERIORITY|||||||0.0002||||||This is the overall treatment effect from the mixed model. p-value threshold set at p = 0.05.|Mixed Models Analysis|||Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||0.0002
71766889|NCT04157673|143035957|OTHER|Effect size of mean differences|Mean Difference (Final Values)|2.75|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Cohen's d effect size = 0.73|Statistical analysis to support visual inspection of the multiple-baseline graphs included the phase changes from baseline to Episodic future thinking treatment. Phase changes were assessed using mixed model with fixed effects of level and trend for baseline phase and random effects for level and trend for treatment phase.||||
71766890|NCT04157673|143035958|OTHER|Effect size of mean pre-post differences|Mean Difference (Final Values)|0.355|STANDARD_DEVIATION|0.295|||TWO_SIDED||||||||cohen's d effect size for mean differences pre to post-treatment = 1.20|||||
71766891|NCT03011892|143035959|SUPERIORITY||Difference in Least Square (LS) Mean|-59.66|||<|0.0001|TWO_SIDED|95.0|-77.85|-41.47|||MMRM|||||-41.47|-77.85|< 0.0001
71766892|NCT03011892|143035960|SUPERIORITY||Difference in LS Mean|-33.01||||0.0004|TWO_SIDED|95.0|-51.27|-14.76|||MMRM|||DB: Vehicle BID, Ruxolitinib 0.15% QD||-14.76|-51.27|0.0004
71766893|NCT03011892|143035960|SUPERIORITY||Difference in LS Mean|-40.9|||<|0.0001|TWO_SIDED|95.0|-59.23|-22.57|||MMRM|||||-22.57|-59.23|< 0.0001
71766894|NCT03011892|143035960|SUPERIORITY||Difference in LS Mean|-54.82|||<|0.0001|TWO_SIDED|95.0|-72.93|-36.7|||MMRM|||||-36.70|-72.93|< 0.0001
71766895|NCT03011892|143035961|SUPERIORITY||Difference in LS Mean|14.63||||0.1127|TWO_SIDED|95.0|-3.47|32.73|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.15% QD||32.73|-3.47|0.1127
71766896|NCT03011892|143035961|SUPERIORITY||Difference in LS Mean|6.74||||0.4659|TWO_SIDED|95.0|-11.44|24.92|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 0.5% QD||24.92|-11.44|0.4659
71766897|NCT03011892|143035961|SUPERIORITY||Difference in LS Mean|-7.18||||0.432|TWO_SIDED|95.0|-25.13|10.77|||MMRM|||Triamcinolone 0.1% BID/Vehicle Cream BID, DB: Ruxolitinib 1.5% QD||10.77|-25.13|0.4320
71766898|NCT03011892|143035961|SUPERIORITY||Difference in LS Mean|-12.02||||0.1903|TWO_SIDED|95.0|-30.05|6.0|||MMRM|||||6.00|-30.05|0.1903
71766899|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-25.12||||0.0009|TWO_SIDED|95.0|-39.84|-10.41|||MMRM|||Week 2||-10.41|-39.84|0.0009
71766900|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-47.85|||<|0.0001|TWO_SIDED|95.0|-62.64|-33.06|||MMRM|||Week 2||-33.06|-62.64|< 0.0001
71766901|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-41.04|||<|0.0001|TWO_SIDED|95.0|-56.0|-26.08|||MMRM|||Week 2||-26.08|-56.00|< 0.0001
71766902|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-45.05|||<|0.0001|TWO_SIDED|95.0|-59.69|-30.4|||MMRM|||Week 2||-30.40|-59.69|< 0.0001
71766903|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|9.99||||0.1806|TWO_SIDED|95.0|-4.66|24.63|||MMRM|||Week 2||24.63|-4.66|0.1806
71766904|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-5.93||||0.4333|TWO_SIDED|95.0|-20.82|8.95|||MMRM|||Week 2||8.95|-20.82|0.4333
71766905|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-9.94||||0.1805|TWO_SIDED|95.0|-24.51|4.63|||MMRM|||Week 2||4.63|-24.51|0.1805
71766906|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-12.74||||0.0895|TWO_SIDED|95.0|-27.45|1.98|||MMRM|||Week 2||1.98|-27.45|0.0895
71766907|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-28.38||||0.0042|TWO_SIDED|95.0|-47.74|-9.02|||MMRM|||Week 8||-9.02|-47.74|0.0042
71766908|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-36.52||||0.0003|TWO_SIDED|95.0|-56.03|-17.01|||MMRM|||Week 8||-17.01|-56.03|0.0003
71766909|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-45.19|||<|0.0001|TWO_SIDED|95.0|||||MMRM|||Week 8||||< 0.0001
71766910|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-57.15|||<|0.0001|TWO_SIDED|95.0|-76.53|-37.77|||MMRM|||Week 8||-37.77|-76.53|< 0.0001
71766911|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|7.78||||0.4243|TWO_SIDED|95.0|-11.37|26.93|||MMRM|||Week 8||26.93|-11.37|0.4243
71766912|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-0.35||||0.9715|TWO_SIDED|95.0|-19.65|18.95|||MMRM|||Week 8||18.95|-19.65|0.9715
71766913|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-9.03||||0.3507|TWO_SIDED|95.0|-28.05|9.99|||MMRM|||Week 8||9.99|-28.05|0.3507
71766914|NCT03011892|143035962|SUPERIORITY||Difference in LS Mean|-20.98||||0.032|TWO_SIDED|95.0|-40.15|-1.82|||MMRM|||Week 8||-1.82|-40.15|0.0320
71766915|NCT02312687|143035978|SUPERIORITY||Least Squares (LS) Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.48|0.88||The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|generalized estimation equation (GEE)|||Change at Week 24||0.88|0.48|< 0.0001
71827872|NCT03425643|143159803|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00517|TWO_SIDED|95.0|0.56|0.93||One-sided p-value based on log-rank test stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Log Rank||Stratified Cox model with Efron's tie handling method with treatment as a covariate stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|||0.93|0.56|0.00517
71827873|NCT03425643|143159804|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Percentage|19.2|||<|1e-05|TWO_SIDED|95.0|13.9|24.7|||Stratified Miettinen and Nurminen|||||24.7|13.9|<0.00001
71656631|NCT04988152|142831258|OTHER||Ratio of geometric least squares means|1.5869|||||TWO_SIDED|90.0|1.1236|2.2413|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUC(D1-29) as the dependent variable, and ethnicity and body weight were covariates.|||2.2413|1.1236|
71656632|NCT04988152|142831273|OTHER||Ratio of geometric least squares means|1.0724|||||TWO_SIDED|90.0|0.8519|1.35|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||1.3500|0.8519|
71656633|NCT04988152|142831275|OTHER||Ratio of geometric least squares means|1.0673|||||TWO_SIDED|90.0|0.9286|1.2268|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates.|||1.2268|0.9286|
71656634|NCT04988152|142831279|OTHER||Ratio of geometric least squares means|1.6999|||||TWO_SIDED|90.0|1.15|2.5129|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with Cmax as the dependent variable, and ethnicity and body weight were covariates.|||2.5129|1.1500|
71656635|NCT04988152|142831281|OTHER||Ratio of geometric least squares means|1.5766|||||TWO_SIDED|90.0|1.1777|2.1106|||||The ratio of geometric LS means and 90% confidence intervals were obtained from ANCOVA model, with AUClast as the dependent variable, and ethnicity and body weight were covariates|||2.1106|1.1777|
71656636|NCT01610453|142831311|SUPERIORITY_OR_OTHER||||||<|0.01||||||A sample size calculation with alpha 0.05, power 0.8, and cut-off level of HPD at 40 mm. 146 women should be included. The calculation was based from a previous study, in which 93% with HPD ≤40 mm and 57% of with HPD \> 40 mm delivered vaginally.|Chi-squared|||Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.||||<0.01
71656637|NCT01610453|142831312|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
71656638|NCT00311311|142831315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0445|TWO_SIDED|95.0|0.001|0.07||P-value and 95% CI for least square (LS) mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|12 months post-transplant||0.070|0.001|0.0445
71656639|NCT00311311|142831315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.0288|TWO_SIDED|95.0|0.004|0.064||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||0.064|0.004|0.0288
71656640|NCT00311311|142831315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0269|TWO_SIDED|95.0|0.004|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||0.060|0.004|0.0269
71656641|NCT00311311|142831315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.097|TWO_SIDED|95.0|-0.005|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||0.060|-0.005|0.0970
71656642|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.39|1.09||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 12 Months Post-transplant||1.09|0.39|<.0001
71656643|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.0022|TWO_SIDED|95.0|0.15|0.67||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 12 Months Post-transplant||0.67|0.15|0.0022
71656644|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.1612|TWO_SIDED|95.0|-0.03|0.19||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 12 Months Post-transplant||0.19|-0.03|0.1612
71656645|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.26|0.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 12 Months Post-transplant||0.86|0.26|0.0005
71656646|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0006|TWO_SIDED|95.0|0.3|1.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 18 Months Post-transplant||1.02|0.30|0.0006
71656647|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.0126|TWO_SIDED|95.0|0.08|0.61||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 18 Months Post-transplant||0.61|0.08|0.0126
71713429|NCT05209386|142943222|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 17 channels and time windows where neural responses differed according to change in F0.|||
71713430|NCT05209386|142943223|OTHER||||||<|0.0001|||||||t-test, 2 sided|t(20.45) = -5.8||||||<0.0001
71713431|NCT05209386|142943224|OTHER||||||<|0.0001|||||||Mixed Models Analysis|For interaction term (effect of interest): t(1016) = -2.7|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||<0.0001
71713432|NCT05209386|142943225|OTHER||||||<|0.0001|||||||Mixed Models Analysis|t(48) = -4.50||The null hypothesis is that there is no effect of change in listening context on behavioral responses of participants.||||<0.0001
71713433|NCT05209386|142943226|OTHER||||||||||||||||||Permutation-based clustering analysis was used to identify channels in non-regions of interest that significantly encode change in acoustic dimensions. For each channel, a sliding-window encoding model was built comparing evoked responses (z-scored voltages) to Canonical Block stimuli across varying F0 with fixed VOT. This analysis identified the n = 4 channels and time windows where neural responses differed according to change in F0.|||
71713434|NCT05209386|142943227|OTHER|||||||0.48|||||||Mixed Models Analysis|For interaction term (effect of interest): t(216) = -0.707|||Time-averaged neural responses across respective windows of significance were averaged for all stimuli with ambiguous VOT (Canonical and Reverse blocks) to provide trial-averaged responses. A single linear mixed-effects model was built with fixed effects of F0, condition/listening context (block), and their interaction, as well as a random effect (intercept only) of patient+channel. The effect of interest was the interaction term, indicating that neural responses to F0 varied according to listening context (block).|||0.480
71713435|NCT04251533|142943240|SUPERIORITY||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.92|2.41|||Regression, Cox|||||2.41|0.92|
71713436|NCT01561469|142943308|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Regression, Logistic|||||||0.009
71713437|NCT01561469|142943309|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Analysis for superinfections category reported.||||1.00
71713438|NCT01561469|142943309|SUPERIORITY_OR_OTHER|||||||0.759|TWO_SIDED||||||Chi-squared|||Analysis for colonization category reported.||||0.759
71713439|NCT01561469|142943310|SUPERIORITY_OR_OTHER|||||||0.773|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.773
71713440|NCT01561469|142943311|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.823
71713441|NCT01561469|142943312|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.276
71713442|NCT01561469|142943313|SUPERIORITY_OR_OTHER|||||||0.512|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.512
71713443|NCT03189719|142943322|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.43|0.75|||Stratified Log-Rank|||OS in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.75|0.43|<0.0001
71713444|NCT03189719|142943323|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0006|TWO_SIDED|95.0|0.6|0.88|||Stratified Log-Rank|||OS in ESCC participants of the pembrolizumab + SOC arm was compared to OS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.88|0.60|0.0006
71713445|NCT03189719|142943324|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Stratified Log-Rank|||OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.78|0.49|<0.0001
71713446|NCT03189719|142943325|SUPERIORITY||Hazard Ratio (HR)|0.73|||<|0.0001|TWO_SIDED|95.0|0.62|0.86|||Stratified Log-Rank|||OS in all participants of the pembrolizumab + SOC arm was compared to OS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.86|0.62|<0.0001
71713447|NCT03189719|142943326|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.78|||Stratified Log-Rank|||PFS in ESCC participants of the pembrolizumab + SOC arm was compared to PFS in ESCC participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.78|0.54|<0.0001
71713448|NCT03189719|142943327|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.65|||Stratified Log-Rank|||PFS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to PFS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.65|0.41|<0.0001
71713449|NCT03189719|142943328|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.76|||Stratified Log-Rank|||PFS in all participants of the pembrolizumab + SOC arm was compared to PFS in all participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||0.76|0.55|<0.0001
71766916|NCT02312687|143035978|SUPERIORITY||LS Mean|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.79||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||0.79|0.57|< 0.0001
71713450|NCT03189719|142943329|SUPERIORITY||Difference in Percentage|15.8|||<|0.0001|TWO_SIDED|95.0|9.0|22.5|||One-sided p-value|||ORR in all participants of the pembrolizumab + SOC arm was compared to ORR in all participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World), tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma), and ECOG performance status (0 versus 1).||22.5|9.0|<0.0001
71713451|NCT03189719|142943330|OTHER||Difference in Percentage|22.8|||<|0.0001|TWO_SIDED|95.0|11.6|33.4|||One-sided p-value|||ORR in ESCC PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in ESCC PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||33.4|11.6|<0.0001
71766917|NCT02312687|143035978|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.75||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||0.75|0.44|< 0.0001
71766918|NCT02312687|143035978|SUPERIORITY||LS Mean|0.47|||<|0.0001|TWO_SIDED|95.0|0.31|0.63||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||0.63|0.31|< 0.0001
71766919|NCT02312687|143035978|SUPERIORITY||LS Mean|0.57|||<|0.0001|TWO_SIDED|95.0|0.41|0.73||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||0.73|0.41|< 0.0001
71766920|NCT02312687|143035978|SUPERIORITY||LS Mean|0.59|||<|0.0001|TWO_SIDED|95.0|0.43|0.76||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||0.76|0.43|< 0.0001
71766921|NCT02312687|143035979|SUPERIORITY||LS Mean|-9.75||||0.1366|TWO_SIDED|95.0|-22.59|3.09||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 24||3.09|-22.59|0.1366
71766922|NCT02312687|143035979|SUPERIORITY||LS Mean|-11.17||||0.1334|TWO_SIDED|95.0|-25.76|3.42||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 48||3.42|-25.76|0.1334
71766923|NCT02312687|143035979|SUPERIORITY||LS Mean|-18.12|||<|0.0001|TWO_SIDED|95.0|-27.07|-9.17||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 72||-9.17|-27.07|< 0.0001
71766924|NCT02312687|143035979|SUPERIORITY||LS Mean|-25.28|||<|0.0001|TWO_SIDED|95.0|-36.21|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 96||-14.35|-36.21|< 0.0001
71766925|NCT02312687|143035979|SUPERIORITY||LS Mean|-22.39|||<|0.0001|TWO_SIDED|95.0|-31.51|-13.26||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 120||-13.26|-31.51|< 0.0001
71766926|NCT02312687|143035979|SUPERIORITY||LS Mean|-28.33|||<|0.0001|TWO_SIDED|95.0|-40.11|-16.56||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 144||-16.56|-40.11|< 0.0001
71713452|NCT03189719|142943331|OTHER||Difference in Percentage|12.8||||0.0009|TWO_SIDED|95.0|4.7|20.7|||One-sided p-value|||ORR in ESCC participants of the pembrolizumab + SOC arm was compared to ORR in ESCC participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||20.7|4.7|0.0009
71766927|NCT02312687|143035980|SUPERIORITY||LS Mean|215493.38|||<|0.0001|TWO_SIDED|95.0|194650.78|236335.97||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||236335.97|194650.78|< 0.0001
71766928|NCT02312687|143035980|SUPERIORITY||LS Mean|202525.38|||<|0.0001|TWO_SIDED|95.0|168364.92|236685.83||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||236685.83|168364.92|< 0.0001
71766929|NCT02312687|143035980|SUPERIORITY||LS Mean|221481.03|||<|0.0001|TWO_SIDED|95.0|179628.07|263333.98||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||263333.98|179628.07|< 0.0001
71766930|NCT02312687|143035980|SUPERIORITY||LS Mean|221674.07|||<|0.0001|TWO_SIDED|95.0|181313.34|262034.81||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||262034.81|181313.34|< 0.0001
71766931|NCT02312687|143035980|SUPERIORITY||LS Mean|208270.02|||<|0.0001|TWO_SIDED|95.0|167217.98|249322.06||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||249322.06|167217.98|< 0.0001
71827874|NCT03425643|143159805|OTHER|Based on Miettinen \& Nurminen method stratified by Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Pertentage|14.2|||<|1e-05|TWO_SIDED|95.0|10.1|18.7|||Stratified Miettinen and Nurminen|||||18.7|10.1|<0.00001
71827875|NCT03425643|143159806|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|1.43||||0.3611|TWO_SIDED|95.0|-1.64|4.49|||t-test, 2 sided|||||4.49|-1.64|0.3611
71827876|NCT03425643|143159807|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the scores as the response variable with covariates for treatment by visit interaction and stratification factors (Stage (II versus III), TPS (\>=50% versus \<50%), Histology (Squamous versus Non-squamous) and Region (East-Asia versus non-East Asia).|Difference in Least Square Means|2.22||||0.1197|TWO_SIDED|95.0|-0.58|5.02|||t-test, 2 sided|||||5.02|-0.58|0.1197
71827877|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.44|0.69||||||"Abdomen 10 minutes~Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.69|-0.44|
71827878|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.36|2.49||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.49|1.36|
71827879|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.73|0.36||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.36|-0.73|
71827880|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.23|||||TWO_SIDED|95.0|1.69|2.78||||||Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.78|1.69|
71827881|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.9|0.31||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.31|-0.90|
71827882|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|1.98|3.22||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.22|1.98|
71827883|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.61|0.57||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.57|-0.61|
71766932|NCT02312687|143035980|SUPERIORITY||LS Mean|235953.55|||<|0.0001|TWO_SIDED|95.0|166110.59|305796.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||305796.52|166110.59|< 0.0001
71827884|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.33|||||TWO_SIDED|95.0|1.72|2.93||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.93|1.72|
71827885|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.91|0.22||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.22|-0.91|
71886774|NCT00523991|143293847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.78||95.0|-0.02|0.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.03|-0.02|0.780
71827886|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.45|||||TWO_SIDED|95.0|1.88|3.01||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||3.01|1.88|
71827887|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.85|0.24||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.24|-0.85|
71886775|NCT00523991|143293848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.61||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.03|0.610
71713453|NCT03189719|142943332|OTHER||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|14.3|33.2|||One-sided p-value|||ORR in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to ORR in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on the Miettinen \& Nurminen method stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||33.2|14.3|<0.0001
71713454|NCT03189719|142943339|OTHER||Difference in LS Means|-0.1||||0.953|TWO_SIDED|95.0|-3.4|3.2|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a constrained longitudinal data analysis (cLDA) model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||3.20|-3.40|0.9530
71713455|NCT03189719|142943340|OTHER||Difference in LS Means|-1.95||||0.5053|TWO_SIDED|95.0|-7.72|3.82|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.82|-7.72|0.5053
71713456|NCT03189719|142943341|OTHER||Difference in LS Means|-0.06||||0.9742|TWO_SIDED|95.0|-3.93|3.81|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||3.81|-3.93|0.9742
71713457|NCT03189719|142943342|OTHER||Difference in LS Means|-1.77||||0.481|TWO_SIDED|95.0|-6.71|3.17|||constrained Longitudinal Data Analysis|||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||3.17|-6.71|0.4810
71713458|NCT03189719|142943343|OTHER||Difference in LS Means|-5.54||||0.0436|TWO_SIDED|95.0|-10.93|-0.16|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.16|-10.93|0.0436
71766933|NCT02312687|143035981|SUPERIORITY||LS Mean|1277.84|||<|0.0001|TWO_SIDED|95.0|1202.34|1353.34||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||1353.34|1202.34|< 0.0001
71713459|NCT03189719|142943343|OTHER||Difference in LS Means|-2.94||||0.0487|TWO_SIDED|95.0|-5.86|-0.02|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||-0.02|-5.86|0.0487
71713460|NCT03189719|142943343|OTHER||Difference in LS Means|-0.93||||0.5932|TWO_SIDED|95.0|-4.36|2.49|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1).||2.49|-4.36|0.5932
71827888|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.41|||||TWO_SIDED|95.0|1.87|2.95||||||Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.95|1.87|
71886776|NCT00523991|143293849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.554||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.554
71713461|NCT03189719|142943344|OTHER||Difference in LS Means|-8.68||||0.0564|TWO_SIDED|95.0|-17.59|0.24|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.24|-17.59|0.0564
71713462|NCT03189719|142943344|OTHER||Difference in LS Means|-2.13||||0.3813|TWO_SIDED|95.0|-6.93|2.66|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.66|-6.93|0.3813
71713463|NCT03189719|142943344|OTHER||Difference in LS Means|-5.11||||0.0816|TWO_SIDED|95.0|-10.86|0.65|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||0.65|-10.86|0.0816
71713464|NCT03189719|142943345|OTHER||Difference in LS Means|-4.49||||0.1632|TWO_SIDED|95.0|-10.81|1.83|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.83|-10.81|0.1632
71713465|NCT03189719|142943345|OTHER||Difference in LS Means|-1.71||||0.3259|TWO_SIDED|95.0|-5.12|1.71|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||1.71|-5.12|0.3259
71713466|NCT03189719|142943345|OTHER||Difference in LS Means|-1.5||||0.4598|TWO_SIDED|95.0|-5.47|2.48|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).||2.48|-5.47|0.4598
71713467|NCT03189719|142943346|OTHER||Difference in LS Means|-8.2||||0.0317|TWO_SIDED|95.0|-15.67|-0.73|||constrained Longitudinal Data Analysis|||DYSPHAGIA: Change from baseline to Week 18 in EORTC QLQ-OES18 Dysphagia subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||-0.73|-15.67|0.0317
71713468|NCT03189719|142943346|OTHER||Difference in LS Means|-3.57||||0.0945|TWO_SIDED|95.0|-7.77|0.62|||constrained Longitudinal Data Analysis|||PAIN: Change from baseline to Week 18 in EORTC QLQ-OES18 Pain subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.62|-7.77|0.0945
71713469|NCT03189719|142943346|OTHER||Difference in LS Means|-4.76||||0.0555|TWO_SIDED|95.0|-9.64|0.11|||constrained Longitudinal Data Analysis|||REFLUX: Change from baseline to Week 18 in EORTC QLQ-OES18 Reflux subscale was compared between treatment arms based on a cLDA model with EORTC QLQ-OES18 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).||0.11|-9.64|0.0555
71827889|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.67|0.4||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.40|-0.67|
71827890|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|1.7|2.8||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.80|1.70|
71713470|NCT03330847|142943355|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9403|TWO_SIDED|90.0|0.63|1.66|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.66|0.63|0.9403
71713471|NCT03330847|142943355|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9282|TWO_SIDED|90.0|0.52|1.88|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib monotherapy.|Patient Population BRCAm||1.88|0.52|0.9282
71827891|NCT03224299|143159841|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 CFU/cm\^2 less than the active control|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.56|0.48||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.48|-0.56|
71713472|NCT03330847|142943355|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.1274|TWO_SIDED|90.0|0.28|1.03|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.03|0.28|0.1274
71766934|NCT02312687|143035981|SUPERIORITY||LS Mean|1244.99|||<|0.0001|TWO_SIDED|95.0|1166.1|1323.88||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1323.88|1166.10|< 0.0001
71766935|NCT02312687|143035981|SUPERIORITY||LS Mean|1298.49|||<|0.0001|TWO_SIDED|95.0|1233.56|1363.43||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||1363.43|1233.56|< 0.0001
71766936|NCT02312687|143035981|SUPERIORITY||LS Mean|1311.05|||<|0.0001|TWO_SIDED|95.0|1238.3|1383.8||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||1383.80|1238.30|< 0.0001
71766937|NCT02312687|143035981|SUPERIORITY||LS Mean|1368.68|||<|0.0001|TWO_SIDED|95.0|1327.4|1409.96||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||1409.96|1327.40|< 0.0001
71766938|NCT02312687|143035981|SUPERIORITY||LS Mean|1298.41|||<|0.0001|TWO_SIDED|95.0|1208.31|1388.51||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||1388.51|1208.31|< 0.0001
71766939|NCT02312687|143035982|SUPERIORITY||LS Mean|7.87||||0.0011|TWO_SIDED|95.0|3.16|12.58||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||12.58|3.16|0.0011
71766940|NCT02312687|143035982|SUPERIORITY||LS Mean|2.7||||0.3092|TWO_SIDED|95.0|-2.5|7.9||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||7.90|-2.50|0.3092
71827892|NCT03224299|143159841|SUPERIORITY||Mean Difference (Final Values)|2.15|||||TWO_SIDED|95.0|1.62|2.68||||||Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.68|1.62|
71713473|NCT03330847|142943355|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.2956|TWO_SIDED|90.0|0.23|1.26|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.26|0.23|0.2956
71713474|NCT03330847|142943355|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2959|TWO_SIDED|90.0|0.5|1.14|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.14|0.50|0.2959
71713475|NCT03330847|142943355|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0193|TWO_SIDED|90.0|0.28|0.8|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||0.80|0.28|0.0193
71713476|NCT03330847|142943356|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.6147|TWO_SIDED|90.0|0.53|1.39|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population BRCAm||1.39|0.53|0.6147
71766941|NCT02312687|143035982|SUPERIORITY||LS Mean|2.62||||0.2958|TWO_SIDED|95.0|-2.29|7.53||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||7.53|-2.29|0.2958
71766942|NCT02312687|143035982|SUPERIORITY||LS Mean|0.31||||0.8796|TWO_SIDED|95.0|-3.71|4.33||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||4.33|-3.71|0.8796
71766943|NCT02312687|143035982|SUPERIORITY||LS Mean|-0.48||||0.8396|TWO_SIDED|95.0|-5.11|4.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||4.16|-5.11|0.8396
71827893|NCT00959920|143159849|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.8||||0.42|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.||||.42
71766944|NCT02312687|143035982|SUPERIORITY||LS Mean|-3.43||||0.2284|TWO_SIDED|95.0|-9.0|2.15||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||2.15|-9.00|0.2284
71766945|NCT02312687|143035983|SUPERIORITY||LS Mean|0.57|||||TWO_SIDED|95.0|0.32|0.83||||||Change at Week 24||0.83|0.32|
71766946|NCT02312687|143035983|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.37|0.56||||||Change at Week 48||0.56|0.37|
71713477|NCT03330847|142943356|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7879|TWO_SIDED|90.0|0.48|1.68|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population BRCAm||1.68|0.48|0.7879
71713478|NCT03330847|142943356|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3695|TWO_SIDED|90.0|0.38|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non BRCAm HRRm||1.31|0.38|0.3695
71713479|NCT03330847|142943356|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.4586|TWO_SIDED|90.0|0.29|1.58|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non BRCAm HRRm||1.58|0.29|0.4586
71713480|NCT03330847|142943356|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.7452|TWO_SIDED|90.0|0.61|1.31|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + ceralasertib.|Patient Population Non HRRm||1.31|0.61|0.7452
71713481|NCT03330847|142943356|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.1185|TWO_SIDED|90.0|0.37|1.0|||Two-sided log-rank tests|Stratified for prior platinum-based therapy (no,yes) using Breslow's approach for handling of ties.|Proportional hazards models based on prior platinum-based therapy (no, yes). Hazard ratio \< 1 favours respective combination treatment related with a longer PFS than olaparib monotherapy. Here, favours olaparib + adavosertib.|Patient Population Non HRRm||1.00|0.37|0.1185
71713482|NCT01355627|142943366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82|STANDARD_ERROR_OF_MEAN|0.23||0.485|||||||Regression, Logistic|Treatment and pooled centre as covariates.|\< 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.|||||0.485
71713483|NCT02293551|142943374|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Squares Mean|1.04||||0.2071|TWO_SIDED|90.0|0.988|1.1|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.10|0.988|0.2071
71713484|NCT02293551|142943374|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.11||||0.0005|TWO_SIDED|90.0|1.06|1.17|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.17|1.06|0.0005
71713485|NCT02293551|142943374|SUPERIORITY_OR_OTHER_LEGACY||Geometric of Ratio Least Square Means|1.08||||0.0123|TWO_SIDED|90.0|1.03|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.03|0.0123
71713486|NCT02293551|142943374|SUPERIORITY_OR_OTHER_LEGACY||Geometric Ratio of Least Square Means|1.07||||0.0331|TWO_SIDED|90.0|1.02|1.13|||Log Rank|Log (PK) model included treatment, period, and sequence group as fixed effects and participant as a random effect.||||1.13|1.02|0.0331
71713487|NCT02293551|142943374|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||Dose proportionality and the degree of dose proportionality was assessed by fitting the power model versus dose. Estimated ratio of dose-normalized geometric means of PK parameters between the highest and lowest doses assessed dose proportionality.|||1.16|1.06|
71713488|NCT04756531|142943390|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|81.21|||||TWO_SIDED|90.0|69.21|95.28||||||||95.28|69.21|
71713489|NCT04756531|142943391|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|76.06|||||TWO_SIDED|90.0|60.14|96.2||||||||96.20|60.14|
71713490|NCT04756531|142943392|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fasted was the test treatment and PF-07321332 250 mg (Suspension), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|56.38|||||TWO_SIDED|90.0|43.42|73.19||||||||73.19|43.42|
71713491|NCT04756531|142943425|OTHER|Natural log transformed AUClast for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|148.91|||||TWO_SIDED|90.0|126.92|174.72||||||||174.72|126.92|
71713492|NCT04756531|142943426|OTHER|Natural log transformed AUCinf for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|146.8|||||TWO_SIDED|90.0|118.8|181.41||||||||181.41|118.80|
71713493|NCT04756531|142943427|OTHER|Natural log transformed Cmax for PF-07321332 was analyzed using a mixed effect model with sequence, period, and treatment included as fixed effects and subject nested within sequence as a random effect. PF-07321332 250 mg (Tablet), Fed was the test treatment and PF-07321332 250 mg (Tablet), Fasted was the reference treatment.|Ratio of Adjusted Geometric Means|244.84|||||TWO_SIDED|90.0|188.58|317.87||||||||317.87|188.58|
71713494|NCT00253422|142943467|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.76|TWO_SIDED|95.0|0.86|1.24|||Log Rank|||||1.24|0.86|0.76
71713495|NCT00253422|142943467|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.83|1.2|||Log Rank|||||1.20|0.83|1.00
71713496|NCT00253422|142943468|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
71713497|NCT00253422|142943468|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
71827894|NCT02628093|143159851|OTHER|Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.||||||0.214||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher's exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.||||0.214
71827895|NCT02628093|143159852|OTHER|||||||0.007||||||P value threshold \<0.05|Wilcoxon (Mann-Whitney)|||compared between groups by the Wilcoxon rank-sum test||||0.007
71827896|NCT02628093|143159856|OTHER|||||||1||||||P value threshold \<0.05|Fisher Exact|||||||1.0
71827897|NCT02525796|143159881|SUPERIORITY||Median Difference (Net)|3.2||||0.84|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and placebo||||0.84
71827898|NCT02525796|143159881|SUPERIORITY||Median Difference (Net)|4.5||||0.54|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between amiloride monotherapy and placebo||||0.54
71713498|NCT00253422|142943470|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71713499|NCT00253422|142943470|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
71713500|NCT00253422|142943472|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR less than 1 favour Faslodex + Arimidex|||1.21|0.84|0.95
71713501|NCT00253422|142943472|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.66|TWO_SIDED|95.0|0.87|1.25|||Log Rank||HR less than 1 favours Faslodex + placebo|||1.25|0.87|0.66
71713502|NCT00253422|142943473|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.91|TWO_SIDED|95.0|0.82|1.19|||Log Rank||HR less than 1 favours Faslodex + Arimidex|||1.19|0.82|0.91
71713503|NCT00253422|142943473|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.31|TWO_SIDED|95.0|0.91|1.32|||Log Rank||HR less than 1 favours Faslodex + Placebo|||1.32|0.91|0.31
71713504|NCT04569084|142943477|SUPERIORITY|||||||0.777|||||||ANCOVA|||||||0.777
71713505|NCT04569084|142943478|SUPERIORITY|||||||0.169|||||||Mixed Model for Repeated Measures (MMRM)|||||||0.169
71713506|NCT01400412|142943486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank sum test stratified by age (\<30 and \>=30 years)||The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48||||<0.001
71713507|NCT05395936|142943545|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71713508|NCT04043286|142943546|SUPERIORITY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.18||0.009|TWO_SIDED|95.0|0.1|0.85|||Wilcoxon (Mann-Whitney)|The Shapiro-Wilk test assessed data normality, and paired t-tests or Wilcoxon tests were applied based on normality results.||The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.||0.85|0.10|0.009
71713509|NCT04043286|142943547|SUPERIORITY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.23||0.049|TWO_SIDED|95.0|-0.0000168|1.25|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||1.25|-0.0000168|0.049
71713510|NCT04043286|142943548|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.15||0.053|TWO_SIDED|95.0|-0.0000522|0.75|||Wilcoxon (Mann-Whitney)|||"The null hypothesis was that there would be no significant difference in peri-implant bone levels between implants with definitive abutments delivered at the time of surgery, and those subjected to multiple abutment disconnections and reconnections. Power analysis was performed and showed that a sample size of 38 implants was needed to achieve 80% power to detect a difference between the null proportion of 0.500 at a significance level of 0.05.~Type of Statistical Test"||0.75|-0.0000522|0.053
71713511|NCT01323192|142943550|SUPERIORITY_OR_OTHER||Difference in least square means|-4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.7|-2.4|||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||-2.4|-6.7|<0.0001
71713512|NCT01323192|142943551|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0002
71713513|NCT01323192|142943552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71713514|NCT01323192|142943553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71713515|NCT01323192|142943554|SUPERIORITY_OR_OTHER||Difference in least square means|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0003|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo|||||0.0003
71713516|NCT01323192|142943555|SUPERIORITY_OR_OTHER|||||||0.4041|||||||ANCOVA|||||||0.4041
71713517|NCT02964377|142943586|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0482|||||||t-test, 2 sided|||||||0.0482
71713518|NCT02964377|142943586|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0075|||||||t-test, 2 sided|||||||0.0075
71713519|NCT02964377|142943586|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0083|||||||t-test, 2 sided|||||||0.0083
71713520|NCT02964377|142943587|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0127|||||||t-test, 2 sided|||||||0.0127
71713521|NCT02964377|142943587|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0202|||||||t-test, 2 sided|||||||0.0202
71713522|NCT02964377|142943587|EQUIVALENCE|Difference in trough vs. peak values was evaluated using a paired t-test analysis.||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71713523|NCT02964377|142943588|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 1)||||<0.0001
71713524|NCT02964377|142943588|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 2)||||<0.0001
71766947|NCT02312687|143035983|SUPERIORITY||LS Mean|0.42|||||TWO_SIDED|95.0|0.28|0.56||||||Change at Week 72||0.56|0.28|
71766948|NCT02312687|143035983|SUPERIORITY||LS Mean|0.44|||||TWO_SIDED|95.0|0.27|0.6||||||Change at Week 96||0.60|0.27|
71766949|NCT02312687|143035983|SUPERIORITY||LS Mean|0.36|||||TWO_SIDED|95.0|0.23|0.48||||||Change at Week 120||0.48|0.23|
71766950|NCT02312687|143035983|SUPERIORITY||LS Mean|0.47|||||TWO_SIDED|95.0|0.32|0.62||||||Change at Week 144||0.62|0.32|
71766951|NCT02312687|143035984|SUPERIORITY||LS Mean|0.04|||||TWO_SIDED|95.0|0.01|0.07||||||Change at Week 24||0.07|0.01|
71766952|NCT02312687|143035984|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 48||0.03|-0.01|
71766953|NCT02312687|143035984|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 72||0.04|-0.01|
71886777|NCT00523991|143293850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.549||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.549
71766954|NCT02312687|143035984|SUPERIORITY||LS Mean|0.05|||||TWO_SIDED|95.0|0.02|0.07||||||Change at Week 96||0.07|0.02|
71766955|NCT02312687|143035984|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
71766956|NCT02312687|143035984|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05||||||Change at Week 144||0.05|-0.01|
71766957|NCT02312687|143035985|SUPERIORITY||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 24||-0.01|-0.07|
71766958|NCT02312687|143035985|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.01||||||Change at Week 48||0.01|-0.03|
71766959|NCT02312687|143035985|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.01||||||Change at Week 72||0.01|-0.04|
71766960|NCT02312687|143035985|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.07|-0.02||||||Change at Week 96||-0.02|-0.07|
71766961|NCT02312687|143035985|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.03|0.02||||||Change at Week 120||0.02|-0.03|
71766962|NCT02312687|143035985|SUPERIORITY||LS Mean|-0.02|||||TWO_SIDED|95.0|-0.05|0.01||||||Change at Week 144||0.01|-0.05|
71766963|NCT02312687|143035986|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.1|0.08||||||Change at Week 24||0.08|-0.10|
71766964|NCT02312687|143035986|SUPERIORITY||LS Mean|0.02|||||TWO_SIDED|95.0|-0.07|0.1||||||Change at Week 48||0.10|-0.07|
71766965|NCT02312687|143035986|SUPERIORITY||LS Mean|0.08|||||TWO_SIDED|95.0|-0.01|0.16||||||Change at Week 72||0.16|-0.01|
71766966|NCT02312687|143035986|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.09|0.06||||||Change at Week 96||0.06|-0.09|
71766967|NCT02312687|143035986|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.1||||||Change at Week 120||0.10|-0.12|
71766968|NCT02312687|143035986|SUPERIORITY||LS Mean|-0.05|||||TWO_SIDED|95.0|-0.16|0.06||||||Change at Week 144||0.06|-0.16|
71766969|NCT02312687|143035987|SUPERIORITY||LS Mean|22.89|||||TWO_SIDED|95.0|-1.81|47.6||||||Change at Week 24||47.60|-1.81|
71766970|NCT02312687|143035987|SUPERIORITY||LS Mean|15.15|||||TWO_SIDED|95.0|-2.32|32.62||||||Change at Week 48||32.62|-2.32|
71766971|NCT02312687|143035987|SUPERIORITY||LS Mean|11.1|||||TWO_SIDED|95.0|-14.33|36.53||||||Change at Week 72||36.53|-14.33|
71766972|NCT02312687|143035987|SUPERIORITY||LS Mean|-16.65|||||TWO_SIDED|95.0|-37.5|4.2||||||Change at Week 96||4.20|-37.50|
71766973|NCT02312687|143035987|SUPERIORITY||LS Mean|3.48|||||TWO_SIDED|95.0|-32.53|39.49||||||Change at Week 120||39.49|-32.53|
71766974|NCT02312687|143035987|SUPERIORITY||LS Mean|28.55|||||TWO_SIDED|95.0|-11.12|68.22||||||Change at Week 144||68.22|-11.12|
71766975|NCT02312687|143035988|SUPERIORITY||LS Mean|-14.77|||||TWO_SIDED|95.0|-87.62|58.08||||||Change at Week 24||58.08|-87.62|
71766976|NCT02312687|143035988|SUPERIORITY||LS Mean|-70.79|||||TWO_SIDED|95.0|-161.31|19.74||||||Change at Week 48||19.74|-161.31|
71886778|NCT00523991|143293851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.568||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.04|-0.02|0.568
71766977|NCT02312687|143035988|SUPERIORITY||LS Mean|-16.11|||||TWO_SIDED|95.0|-110.96|78.73||||||Change at Week 72||78.73|-110.96|
71766978|NCT02312687|143035988|SUPERIORITY||LS Mean|-41.74|||||TWO_SIDED|95.0|-150.61|67.13||||||Change at Week 96||67.13|-150.61|
71766979|NCT02312687|143035988|SUPERIORITY||LS Mean|-76.11|||||TWO_SIDED|95.0|-237.29|85.08||||||Change at Week 120||85.08|-237.29|
71766980|NCT02312687|143035988|SUPERIORITY||LS Mean|-96.06|||||TWO_SIDED|95.0|-206.59|14.46||||||Change at Week 144||14.46|-206.59|
71766981|NCT02312687|143035989|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Change at Week 24||0.03|-0.01|
71766982|NCT02312687|143035989|SUPERIORITY||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04||||||Change at Week 48||0.04|-0.01|
71766983|NCT02312687|143035989|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.02||||||Change at Week 72||0.02|-0.02|
71766984|NCT02312687|143035989|SUPERIORITY||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||Change at Week 96||0.02|-0.04|
71766985|NCT02312687|143035989|SUPERIORITY||LS Mean|0.0|||||TWO_SIDED|95.0|-0.02|0.03||||||Change at Week 120||0.03|-0.02|
71766986|NCT02312687|143035989|SUPERIORITY||LS Mean|0.03|||||TWO_SIDED|95.0|-0.01|0.08||||||Change at Week 144||0.08|-0.01|
71766987|NCT02312687|143035990|SUPERIORITY||LS Mean|14.92||||0.0314|TWO_SIDED|95.0|1.33|28.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||28.52|1.33|0.0314
71827899|NCT02525796|143159881|SUPERIORITY||Median Difference (Net)|7.6||||0.58|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in PTH over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.58
71713525|NCT02964377|142943588|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4 (Cohort 3)||||<0.0001
71713526|NCT02964377|142943588|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 1)||||<0.0001
71713527|NCT02964377|142943588|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 2)||||<0.0001
71713528|NCT02964377|142943588|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8 (Cohort 3)||||<0.0001
71713529|NCT02964377|142943591|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 4||||0.002
71713530|NCT02964377|142943591|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.001
71713531|NCT02964377|142943591|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713532|NCT02964377|142943591|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713533|NCT02964377|142943591|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713534|NCT02964377|142943591|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713535|NCT02964377|142943592|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713536|NCT02964377|142943592|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713537|NCT02964377|142943592|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713538|NCT02964377|142943592|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713539|NCT02964377|142943592|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713540|NCT02964377|142943592|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713541|NCT02964377|142943593|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713542|NCT02964377|142943593|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713543|NCT02964377|142943593|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713544|NCT02964377|142943593|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713545|NCT02964377|142943593|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713546|NCT02964377|142943593|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71827900|NCT02525796|143159882|SUPERIORITY||Median Difference (Net)|0.0||||0.82|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and placebo||||0.82
71713547|NCT02964377|142943594|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.012|||||||Regression, Linear|||Baseline vs. Week 4||||0.012
71713548|NCT02964377|142943594|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713549|NCT02964377|142943594|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 4||||<0.0001
71713550|NCT02964377|142943594|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 8||||0.01
71713551|NCT02964377|142943594|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713552|NCT02964377|142943594|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.0001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.0001
71713553|NCT02964377|142943596|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.01|||||||Regression, Linear|||Baseline vs. Week 4||||0.01
71713554|NCT02964377|142943596|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.019|||||||Regression, Linear|||Baseline vs. Week 4||||0.019
71713555|NCT02964377|142943596|OTHER|Mixed Model Repeated Measures (MMRM) regression|||||<|0.001|||||||Regression, Linear|||Baseline vs. Week 8||||<0.001
71713556|NCT02964377|142943596|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.05|||||||Regression, Linear|||Baseline vs. Week 8||||0.05
71713557|NCT02964377|142943597|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.054||||||p-value for difference at Week 4|Regression, Linear|||Baseline vs. Week 8||||0.054
71713558|NCT02964377|142943597|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.009|||||||Regression, Linear|||Baseline vs. Week 4||||0.009
71713559|NCT02964377|142943598|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.025|||||||Regression, Linear|||Baseline vs. Week 8||||0.025
71713560|NCT02964377|142943598|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.026|||||||Regression, Linear|||Baseline vs. Week 4||||0.026
71713561|NCT02964377|142943599|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.006|||||||Regression, Linear|||Baseline vs. Week 4||||0.006
71713562|NCT02964377|142943599|OTHER|Mixed Model Repeated Measures (MMRM) regression||||||0.002|||||||Regression, Linear|||Baseline vs. Week 8||||0.002
71713563|NCT03674281|142943635|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71713564|NCT03674281|142943635|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71713565|NCT00710593|142943639|SUPERIORITY_OR_OTHER||% of participants who were responders|97.5||||0.1613|TWO_SIDED|95.0|86.8|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|86.8|0.1613
71827901|NCT02525796|143159882|SUPERIORITY||Median Difference (Net)|0.1||||0.21|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between amiloride monotherapy and placebo||||0.21
71766988|NCT02312687|143035990|SUPERIORITY||LS Mean|-1.73||||0.764|TWO_SIDED|95.0|-13.0|9.55||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||9.55|-13.00|0.7640
71766989|NCT02312687|143035990|SUPERIORITY||LS Mean|-22.28|||<|0.0001|TWO_SIDED|95.0|-30.2|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-14.35|-30.20|< 0.0001
71766990|NCT02312687|143035990|SUPERIORITY||LS Mean|-20.93|||<|0.0001|TWO_SIDED|95.0|-27.92|-13.94||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-13.94|-27.92|< 0.0001
71766991|NCT02312687|143035990|SUPERIORITY||LS Mean|-18.77||||0.0094|TWO_SIDED|95.0|-32.93|-4.6||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-4.60|-32.93|0.0094
71766992|NCT02312687|143035990|SUPERIORITY||LS Mean|-25.72|||<|0.0001|TWO_SIDED|95.0|-36.89|-14.54||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-14.54|-36.89|< 0.0001
71766993|NCT02312687|143035991|SUPERIORITY||LS Mean|4.68||||0.1673|TWO_SIDED|95.0|-1.96|11.32||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||11.32|-1.96|0.1673
71766994|NCT02312687|143035991|SUPERIORITY||LS Mean|-2.68||||0.233|TWO_SIDED|95.0|-7.09|1.72||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||1.72|-7.09|0.2330
71766995|NCT02312687|143035991|SUPERIORITY||LS Mean|-7.45|||<|0.0001|TWO_SIDED|95.0|-9.54|-5.36||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||-5.36|-9.54|< 0.0001
71766996|NCT02312687|143035991|SUPERIORITY||LS Mean|-8.08|||<|0.0001|TWO_SIDED|95.0|-9.86|-6.29||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||-6.29|-9.86|< 0.0001
71766997|NCT02312687|143035991|SUPERIORITY||LS Mean|-10.01|||<|0.0001|TWO_SIDED|95.0|-13.07|-6.95||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||-6.95|-13.07|< 0.0001
71766998|NCT02312687|143035991|SUPERIORITY||LS Mean|-10.89|||<|0.0001|TWO_SIDED|95.0|-14.77|-7.02||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||-7.02|-14.77|< 0.0001
71766999|NCT02312687|143035992|SUPERIORITY||LS Mean|343.38||||0.0113|TWO_SIDED|95.0|77.66|609.11||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||609.11|77.66|0.0113
71767000|NCT02312687|143035992|SUPERIORITY||LS Mean|41.45||||0.4972|TWO_SIDED|95.0|-78.23|161.13||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||161.13|-78.23|0.4972
71767001|NCT02312687|143035992|SUPERIORITY||LS Mean|-61.96||||0.3288|TWO_SIDED|95.0|-186.34|62.41||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||62.41|-186.34|0.3288
71767002|NCT02312687|143035992|SUPERIORITY||LS Mean|-68.62||||0.2772|TWO_SIDED|95.0|-192.39|55.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||55.16|-192.39|0.2772
71767003|NCT02312687|143035992|SUPERIORITY||LS Mean|-53.41||||0.2907|TWO_SIDED|95.0|-152.47|45.66||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||45.66|-152.47|0.2907
71767004|NCT02312687|143035992|SUPERIORITY||LS Mean|-97.46||||0.08|TWO_SIDED|95.0|-206.57|11.65||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||11.65|-206.57|0.0800
71767005|NCT02312687|143035993|SUPERIORITY||LS Mean|72.45|||<|0.0001|TWO_SIDED|95.0|39.21|105.7||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24||105.70|39.21|< 0.0001
71767006|NCT02312687|143035993|SUPERIORITY||LS Mean|44.4|||<|0.0001|TWO_SIDED|95.0|30.34|58.47||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48||58.47|30.34|< 0.0001
71767007|NCT02312687|143035993|SUPERIORITY||LS Mean|28.3||||0.0002|TWO_SIDED|95.0|13.24|43.37||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72||43.37|13.24|0.0002
71767008|NCT02312687|143035993|SUPERIORITY||LS Mean|27.02|||<|0.0001|TWO_SIDED|95.0|13.81|40.22||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96||40.22|13.81|< 0.0001
71767009|NCT02312687|143035993|SUPERIORITY||LS Mean|13.02||||0.1195|TWO_SIDED|95.0|-3.37|29.4||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120||29.40|-3.37|0.1195
71827902|NCT02525796|143159882|SUPERIORITY||Median Difference (Net)|0.1||||0.12|TWO_SIDED||||||ANOVA|||ANOVA comparing the change in serum calcium over 4 weeks between eplerenone monotherapy and amiloride monotherapy||||0.12
71827903|NCT02729701|143159896|OTHER|||||||0.017||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change by paired two-sample non-parametric test||||0.017
71827904|NCT02729701|143159897|OTHER|||||||0.043||||||a priori threshold for statistical significance \<0.05|Wilcoxon (Mann-Whitney)|2-sided||Test for within-group change via paired, two-sample non-parametric test||||0.043
71827905|NCT02729701|143159898|OTHER|||||||0.088||||||a priori threshold for statistical significance \< 0.05|Wilcoxon (Mann-Whitney)|||Test for within-group change using paired two-sample non-parametric etst||||0.088
71827906|NCT00970307|143159903|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.76|||||TWO_SIDED|95.0|-4.21|2.22||||||||2.22|-4.21|
71827907|NCT00970307|143159904|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardized asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.72|||||TWO_SIDED|95.0|-5.19|3.57||||||||3.57|-5.19|
71827908|NCT05372094|143159958|OTHER|||||||0.007|||||||Mixed Models Analysis|||Fixed factor of program and random intercept of participant||||0.007
71827909|NCT05372094|143159958|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting OFF and noise reduction setting STRONG||||< 0.05
71827910|NCT05372094|143159958|OTHER||||||<|0.01|||||||Mixed Models Analysis|||Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAK||||<0.01
71713566|NCT00710593|142943640|SUPERIORITY_OR_OTHER||% of participants who were responders|96.8||||0.0534|TWO_SIDED|95.0|89.0|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.9|89.0|0.0534
71713567|NCT00710593|142943641|SUPERIORITY_OR_OTHER||% of participants who were responders|96.1||||0.0427|TWO_SIDED|95.0|86.5|99.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||99.5|86.5|0.0427
71713568|NCT00710593|142943642|SUPERIORITY_OR_OTHER||% of participants who were responders|92.5||||0.0006|TWO_SIDED|95.0|83.4|97.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.||97.5|83.4|0.0006
71713569|NCT00710593|142943643|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|49.3||||0.8305|TWO_SIDED|95.0||||The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
71713570|NCT00710593|142943643|SUPERIORITY_OR_OTHER||% of participants with at least 1 event|46.7||||0.8305|TWO_SIDED|||||The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected|||||||0.8305
71713571|NCT00710593|142943651|SUPERIORITY_OR_OTHER||Overall aquisition rate|7.9||||1||95.0|||||Fisher Exact|P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.||||||1.000
71713572|NCT00710593|142943652|SUPERIORITY_OR_OTHER||Overall aquisition rate|1.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713573|NCT00710593|142943653|SUPERIORITY_OR_OTHER||Overall aquisition rate|2.0||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713574|NCT00710593|142943654|SUPERIORITY_OR_OTHER||Overall aquisition rate|4.5||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713575|NCT00710593|142943655|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713576|NCT00710593|142943656|SUPERIORITY_OR_OTHER||Overall aquistion rate|3.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713577|NCT00710593|142943657|SUPERIORITY_OR_OTHER||Overall aquisition rate|6.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713578|NCT00710593|142943658|SUPERIORITY_OR_OTHER||Overall aquisition rate|8.1||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact|||||||1.000
71713579|NCT00710593|142943659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.0004|TWO_SIDED|95.0|1.02|1.1|||Regression, Logistic|||||1.1|1.02|0.0004
71713580|NCT00710593|142943660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.0012|TWO_SIDED|95.0|1.0|1.1|||Regression, Logistic|||||1.1|1.0|0.0012
71713581|NCT00710593|142943661|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71713582|NCT01444911|142943704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||||||0.89
71827911|NCT05372094|143159958|OTHER||||||>|0.05|||||||Mixed Models Analysis|||"Follow up comparison between ratings of effort with OFF and WEAK"||||>.05
71827912|NCT05372094|143159959|OTHER|||||||0.283|||||||Mixed Models Analysis|||||||0.283
71827913|NCT05372094|143159960|OTHER|||||||0.145|||||||Mixed Models Analysis|||Analysis was done only between NR OFF and NR at a custom or preferred setting.||||0.145
71827914|NCT05372094|143159961|OTHER|||||||0.3018|||||||Exact Binomial test|||An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.||||0.3018
71827915|NCT05372094|143159962|OTHER|||||||0.1796|||||||Exact Binomial test|||Exact binomial test was done to evaluate if the majority (\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.||||0.1796
71827916|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.49|||<|0.001|TWO_SIDED|95.0|1.55|3.99|||Log Rank|||All participants: p-value was calculated using log-rank test.||3.99|1.55|<0.001
71713583|NCT00069641|142943712|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.96|STANDARD_ERROR_OF_MEAN|6.47||0.0049|TWO_SIDED|95.0|5.99|31.93|||ANCOVA|||p-value for treatment difference based on Analysis of covariance (ANCOVA) model containing treatment, region, baseline participant age, and baseline disease score.||31.93|5.99|0.0049
71713584|NCT03186638|142943715|SUPERIORITY|||||||0.7917|||||||ANCOVA|Adjusted for Baseline values||||||0.7917
71713585|NCT01263119|142943716|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.07|||||TWO_SIDED|90.0|1.0|1.13|||Mixed Models Analysis|||||1.13|1.00|
71713586|NCT01263119|142943717|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.07|1.16|||Mixed Models Analysis|||||1.16|1.07|
71713587|NCT01263119|142943718|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9551|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.9551
71713588|NCT01263119|142943719|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.15|||||TWO_SIDED|90.0|1.1|1.2|||Mixed Models Analysis|||||1.20|1.10|
71767010|NCT02312687|143035993|SUPERIORITY||LS Mean|43.12||||0.2009|TWO_SIDED|95.0|-22.96|109.2||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144||109.20|-22.96|0.2009
71767011|NCT00223236|143036036|SUPERIORITY_OR_OTHER|||||||0.4637|||||||Chi-squared|df=1 n=34||Null hypothsis is no group association in cocaine use.||||.4637
71767012|NCT01181986|143036040|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence, group (diabetes duration) and time.||||||<0.0001
71827917|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.38||||0.002|TWO_SIDED|95.0|1.57|7.28|||Regression, Cox|||Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.||7.28|1.57|0.002
71713589|NCT01263119|142943720|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.13|||||TWO_SIDED|90.0|1.09|1.17|||Mixed Models Analysis|||||1.17|1.09|
71713590|NCT01263119|142943721|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6094|TWO_SIDED|90.0|-0.5|0.02|||Wilcoxon (Mann-Whitney)|||||0.02|-0.50|0.6094
71713591|NCT01263119|142943722|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.02|1.05|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.||1.05|1.02|
71713592|NCT01263119|142943723|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.08|||Mixed Models Analysis|||Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.||1.08|1.01|
71713593|NCT05067335|142943736|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|9.37|STANDARD_ERROR_OF_MEAN|0.524|<|0.001|TWO_SIDED|95.0|8.34|10.39|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||10.39|8.34|<0.001
71713594|NCT05067335|142943739|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|2.86|STANDARD_ERROR_OF_MEAN|0.348|<|0.001|TWO_SIDED|95.0|2.18|3.54|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||3.54|2.18|<0.001
71713595|NCT05067335|142943740|SUPERIORITY||Difference in LSM(Romosozumab - Placebo)|3.48|STANDARD_ERROR_OF_MEAN|0.458|<|0.001|TWO_SIDED|95.0|2.58|4.38|||ANCOVA|||The ANCOVA model was used and included treatment group, Baseline DXA BMD value, machine type (hologic or lunar) at Baseline, age strata group (stratification factor), region, and interaction of Baseline DXA BMD value and machine type at Baseline as independent variables.||4.38|2.58|<0.001
71713596|NCT00261833|142943744|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.618||||0.029|TWO_SIDED|95.0|-0.024|1.261||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval \[CI\] being greater than zero) will indicate superiority of Zemaira compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.261|-0.024|0.029
71767013|NCT01181986|143036040|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANCOVA|Adjusted for treatment sequence.||||||0.006
71767014|NCT01181986|143036040|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for treatment sequence.||||||0.003
71767015|NCT01181986|143036041|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence and diabetes duration group.||||||<0.0001
71767016|NCT01181986|143036042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71767017|NCT03720652|143036045|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.18|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.18
71767018|NCT03720652|143036045|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
71767019|NCT03720652|143036045|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.13|||||||McNemar|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.13
71767020|NCT03720652|143036046|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.7|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.70
71767021|NCT03720652|143036046|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.66|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.66
71767022|NCT03720652|143036046|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.84|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.84
71767023|NCT03720652|143036047|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.015|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.015
71767024|NCT03720652|143036047|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.34|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.34
71767025|NCT03720652|143036047|OTHER|The statistical test is a paired test assessing change at the End-of-Program Interview relative to baseline.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.002
71767026|NCT03720652|143036048|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.022|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.022
71767027|NCT03720652|143036048|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
71767028|NCT03720652|143036048|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.09|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.090
71767029|NCT03720652|143036049|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.051|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.051
71827918|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.03||||0.021|TWO_SIDED|95.0|1.11|3.68|||Regression, Cox|||Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||3.68|1.11|0.021
71767030|NCT03720652|143036049|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.044|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.044
71767031|NCT03720652|143036049|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||1|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||1.00
71767032|NCT03720652|143036050|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.023
71767033|NCT03720652|143036050|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.56|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.56
71767034|NCT03720652|143036050|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.16|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.16
71767035|NCT03720652|143036051|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.15|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.15
71767036|NCT03720652|143036051|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.12|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.12
71767037|NCT03720652|143036051|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.018|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.018
71767038|NCT03720652|143036052|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.33|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.33
71767039|NCT03720652|143036052|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.88|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.88
71767040|NCT03720652|143036052|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.67|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.67
71767041|NCT03720652|143036053|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71767042|NCT03720652|143036053|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71827919|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.82|||<|0.001|TWO_SIDED|95.0|1.7|4.67|||Regression, Cox|||Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||4.67|1.70|<0.001
71827920|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||<|0.001|TWO_SIDED|95.0|1.7|5.04|||Regression, Cox|||Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.04|1.70|<0.001
71827921|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.62||||0.012|TWO_SIDED|95.0|1.32|9.89|||Regression, Cox|||Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||9.89|1.32|0.012
71767043|NCT03720652|143036053|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71767044|NCT03720652|143036054|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.17
71767045|NCT03720652|143036054|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.02|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.020
71767046|NCT03720652|143036054|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.062|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.062
71767047|NCT03720652|143036055|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.013|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.013
71767048|NCT03720652|143036055|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
71767049|NCT03720652|143036055|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.003|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.003
71827922|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.12||||0.006|TWO_SIDED|95.0|1.39|6.98|||Regression, Cox|||Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||6.98|1.39|0.006
71767050|NCT03720652|143036056|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.001
71767051|NCT03720652|143036056|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.01|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.010
71767052|NCT03720652|143036056|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.085|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.085
71767053|NCT03720652|143036057|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71767054|NCT03720652|143036057|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71656648|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.238|TWO_SIDED|95.0|-0.04|0.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 18 Months Post-transplant||0.17|-0.04|0.2380
71767055|NCT03720652|143036057|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71827923|NCT01193153|143159966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.93||||0.238|TWO_SIDED|95.0|0.65|5.78|||Regression, Cox|||Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.||5.78|0.65|0.238
71827924|NCT01193153|143159967|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.68|5.95||P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.|MMRM ANCOVA|||The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.||5.95|0.68|0.014
71656649|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0003|TWO_SIDED|95.0|0.27|0.88||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 18 Months Post-transplant||0.88|0.27|0.0003
71713597|NCT00261833|142943744|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.74||||0.017|TWO_SIDED|95.0|0.059|1.42||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.420|0.059|0.017
71767056|NCT03720652|143036058|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.||||||0.046|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.046
71767057|NCT03720652|143036058|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.14
71767058|NCT03720652|143036058|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||0.058
71767059|NCT03720652|143036059|OTHER|The statistical test is a paired test assessing change at the End-of-Intervention Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71767060|NCT03720652|143036059|OTHER|The statistical test is a paired test assessing change at the 3-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71827925|NCT01193153|143159969|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|1.94|7.15||Change at Endpoint (Week 64/LOCF)|ANCOVA|||||7.15|1.94|<0.001
71827926|NCT00470106|143160050|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Not corrected for multiple comparisons because it is primary.|mixed model|same analysis as for secondary outcome variable.||||||<.001
71827927|NCT00470106|143160051|SUPERIORITY_OR_OTHER||||||<|0.1||||||A priori threshold for significance was P \< .05|mixed model|Same as for the primary variable.||||||<.10
71827928|NCT00758602|143160064|SUPERIORITY_OR_OTHER||LS Mean difference|0.6581||||0.0813|TWO_SIDED|95.0|-0.08|1.4||p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||1.40|-0.08|0.0813
71827929|NCT00758602|143160065|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5977||||0.7949|TWO_SIDED|95.0|-13.77|10.58||p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA|||||10.58|-13.77|0.7949
71827930|NCT00758602|143160066|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 6 months post-transplant||||0.6812
71827931|NCT00758602|143160066|SUPERIORITY_OR_OTHER|||||||0.6812|||||||Fisher Exact|||Acute rejection, 12 months post-transplant||||0.6812
71827932|NCT00758602|143160066|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Death, 12 months post-transplant||||1.0000
71827933|NCT00758602|143160068|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0000
71827934|NCT00758602|143160069|SUPERIORITY_OR_OTHER|||||||0.4586|||||||Fisher Exact|||||||0.4586
71827935|NCT00758602|143160070|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71827936|NCT00855465|143160133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis, due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew/died before 16 weeks were imputed with a worst value of 0m in case of death/clinical worsening without termination visit and with the last observed value otherwise. Comparison was done using analysis of covariance (ANCOVA), with baseline 6MWD as a covariate and treatment group and region as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant.||||<0.0001
71827937|NCT00855465|143160133|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|45.69|||<|0.0001|TWO_SIDED|95.0|24.74|66.63||Additional analysis, due to result of Shapiro-Wilk test.|ANCOVA|||||66.63|24.74|<0.0001
71827938|NCT00855465|143160133|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71827939|NCT00855465|143160134|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
71827940|NCT00855465|143160134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-246.43|||<|0.0001|TWO_SIDED|95.0|-303.33|-189.53||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-189.53|-303.33|<0.0001
71713598|NCT00261833|142943744|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.478||||0.09|TWO_SIDED|95.0|-0.223|1.18||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||1.180|-0.223|0.090
71713599|NCT00261833|142943748|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.04||||0.058|TWO_SIDED|95.0|-0.26|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.26|0.058
71713600|NCT00261833|142943748|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.32||||0.028|TWO_SIDED|95.0|-0.03|2.67||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects at a 1-sided significance level of 0.025.||2.67|-0.03|0.028
71713601|NCT00261833|142943748|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.89||||0.115|TWO_SIDED|95.0|-0.57|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect at a 1-sided significance level of 0.025.||2.34|-0.57|0.115
71713602|NCT00402987|142943766|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.0003||95.0|5.5|17.9|||generalized linear model|p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.||17.9|5.5|0.0003
71713603|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.212
71713604|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.056
71713605|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71713606|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71713607|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713608|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713609|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713610|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713611|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713612|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713613|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713614|NCT00402987|142943767|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713615|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713616|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713617|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
71713618|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
71713619|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.014
71713620|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
71713621|NCT00402987|142943768|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.365
71713622|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
71713623|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
71713624|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
71713625|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71713626|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713627|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713628|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713629|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713630|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713631|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713632|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713633|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713634|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.096
71713635|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.034
71713636|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
71713637|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.010
71713638|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71713639|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71713640|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713641|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713642|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71827941|NCT00855465|143160134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71767061|NCT03720652|143036059|OTHER|The statistical test is a paired test assessing change at the 6-Month Follow Up Interview relative to baseline.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||As the study design is quasi-experimental, there is no comparison group - both arms were analyzed jointly for each pre- and post- time interval.||||<0.001
71767062|NCT03073733|143036066|SUPERIORITY||least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.9||0.582|TWO_SIDED|95.0|-10.3|5.8|||linear model for repeated measures|||||5.8|-10.3|0.582
71767063|NCT03073733|143036066|SUPERIORITY||least squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.91||0.984|TWO_SIDED|95.0|-8.2|8.0|||linear model for repeated measures|||||8.0|-8.2|0.984
71767064|NCT03073733|143036067|SUPERIORITY||least squares mean difference|1.2986|STANDARD_ERROR_OF_MEAN|0.8744||0.29|TWO_SIDED|95.0|-1.1341|3.7313|||linear model for repeated measures|||||3.7313|-1.1341|0.290
71767065|NCT03073733|143036067|SUPERIORITY||least squares mean difference|-0.3542|STANDARD_ERROR_OF_MEAN|0.7793||0.759|TWO_SIDED|95.0|-2.6516|1.9433|||linear model for repeated measures|||||1.9433|-2.6516|0.759
71767066|NCT03073733|143036068|SUPERIORITY||least squares mean difference|-278.73|STANDARD_ERROR_OF_MEAN|305.192||0.515|TWO_SIDED|95.0|-1126.21|568.75|||linear model for repeated measures|||||568.75|-1126.21|0.515
71767067|NCT03073733|143036068|SUPERIORITY||least squares mean difference|292.18|STANDARD_ERROR_OF_MEAN|308.659||0.499|TWO_SIDED|95.0|-562.87|1147.23|||linear model for repeated measures|||||1147.23|-562.87|0.499
71767068|NCT03073733|143036069|SUPERIORITY||least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42||0.16|TWO_SIDED|95.0|-2.1|0.3|||linear model for repeated measures|||||0.3|-2.1|0.160
71767069|NCT03073733|143036069|SUPERIORITY||least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.622|TWO_SIDED|95.0|-1.5|0.9|||linear model for repeated measures|||||0.9|-1.5|0.622
71767070|NCT03073733|143036070|SUPERIORITY||least squares mean difference|-0.111|STANDARD_ERROR_OF_MEAN|0.1038||0.442|TWO_SIDED|95.0|-0.399|0.176|||linear model for repeated measures|||||0.176|-0.399|0.442
71827942|NCT00855465|143160135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
71767071|NCT03073733|143036070|SUPERIORITY||least squares mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.1037||0.401|TWO_SIDED|95.0|-0.165|0.409|||linear model for repeated measures|||||0.409|-0.165|0.401
71767072|NCT03073733|143036072|SUPERIORITY|||||||0.205|||||||Fisher Exact|||||||0.205
71767073|NCT03073733|143036073|SUPERIORITY|||||||0.157|||||||Fisher Exact|||||||0.157
71767074|NCT03073733|143036074|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
71767075|NCT03073733|143036075|SUPERIORITY|||||||0.173|||||||Fisher Exact|||||||0.173
71767076|NCT03073733|143036076|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.2)||||||0.099
71767077|NCT03073733|143036076|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9)||||||0.130
71767078|NCT03073733|143036077|SUPERIORITY|||||||0.0959|||||||Fisher Exact|||||||0.0959
71767079|NCT03073733|143036078|SUPERIORITY|||||||0.1868|||||||Fisher Exact|||||||0.1868
71767080|NCT03073733|143036079|SUPERIORITY|||||||0.608|||||||Fisher Exact|||||||0.608
71767081|NCT03073733|143036080|SUPERIORITY|||||||0.264|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.264
71767082|NCT03073733|143036080|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.9)||||||0.139
71767083|NCT03073733|143036081|SUPERIORITY|||||||0.261|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 7.9)||||||0.261
71767084|NCT03073733|143036081|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.3)||||||0.139
71767085|NCT03073733|143036082|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.8).||||||0.350
71827943|NCT00855465|143160135|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-443.99||||0.0293|TWO_SIDED|95.0|-842.95|-45.03||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-45.03|-842.95|0.0293
71827944|NCT00855465|143160135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71767086|NCT03073733|143036082|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.500
71767087|NCT03073733|143036083|SUPERIORITY|||||||0.22|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.9).||||||0.220
71767088|NCT03073733|143036083|SUPERIORITY|||||||0.119|||||||t-test, 1 sided|Pooled t-test (variance ratio of 1.9).||||||0.119
71767089|NCT03073733|143036084|SUPERIORITY|||||||0.006|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.7)||||||0.006
71767090|NCT03073733|143036085|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71767091|NCT03073733|143036086|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
71767092|NCT03073733|143036087|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.010
71767093|NCT03073733|143036088|SUPERIORITY|||||||0.072|||||||Fisher Exact|||||||0.072
71767094|NCT03073733|143036089|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.9)||||||0.019
71767095|NCT03073733|143036089|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.019
71767096|NCT03073733|143036090|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
71767097|NCT03073733|143036091|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
71767098|NCT03073733|143036092|SUPERIORITY|||||||0.199|||||||Fisher Exact|||||||0.199
71767099|NCT03073733|143036093|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 56.3)||||||0.075
71767100|NCT03073733|143036093|SUPERIORITY|||||||0.062|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 25.2)||||||0.062
71767101|NCT03073733|143036094|SUPERIORITY|||||||0.255|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.9)||||||0.255
71767102|NCT03073733|143036094|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.7)||||||0.109
71767103|NCT03073733|143036095|SUPERIORITY|||||||0.488|||||||t-test, 1 sided|Pooled t-test (variance ratio of 0.7).||||||0.488
71767104|NCT03073733|143036095|SUPERIORITY|||||||0.273|||||||t-test, 1 sided|Pooled t-test (variance ratio of 2.5)||||||0.273
71767105|NCT03073733|143036096|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71767106|NCT03073733|143036097|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71767107|NCT03073733|143036098|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
71827945|NCT00855465|143160136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0026
71827946|NCT00855465|143160137|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.37||||0.1724|TWO_SIDED|95.0|-8.72|1.99||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region.|Based on Mantel-Haenszel estimate stratified by region.|"Test for difference of occurence of Any event."||1.99|-8.72|0.1724
71767108|NCT03073733|143036099|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
71767109|NCT03073733|143036100|SUPERIORITY|||||||0.019|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 8.2)||||||0.019
71767110|NCT03073733|143036100|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.7)||||||0.011
71767111|NCT03073733|143036101|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
71767112|NCT03073733|143036102|SUPERIORITY|||||||0.096|||||||Fisher Exact|||||||0.096
71767113|NCT03073733|143036103|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.480
71767114|NCT03073733|143036104|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 51.5)||||||0.076
71767115|NCT03073733|143036104|SUPERIORITY|||||||0.057|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 26.1)||||||0.057
71767116|NCT03073733|143036105|SUPERIORITY|||||||0.117|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 29.0)||||||0.117
71767117|NCT03073733|143036105|SUPERIORITY|||||||0.083|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 9.5)||||||0.083
71767118|NCT03073733|143036106|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 6.7)||||||0.172
71767119|NCT03073733|143036106|SUPERIORITY|||||||0.14|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.98)||||||0.140
71767120|NCT03073733|143036107|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 5.4).||||||0.011
71767121|NCT03073733|143036108|SUPERIORITY|||||||0.0406|||||||Fisher Exact|||||||0.0406
71767122|NCT03073733|143036109|SUPERIORITY|||||||0.007|||||||Fisher Exact|||||||0.007
71767123|NCT03073733|143036110|SUPERIORITY|||||||0.026|||||||Fisher Exact|||||||0.026
71767124|NCT03073733|143036111|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
71767125|NCT03073733|143036112|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 22.2)||||||0.030
71767126|NCT03073733|143036112|SUPERIORITY|||||||0.033|||||||t-test, 1 sided|Pooled t-test (variance ratio of 3.3)||||||0.033
71827947|NCT00855465|143160138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0035
71886779|NCT00523991|143293853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.358||95.0|-0.18|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.07|-0.18|0.358
71886780|NCT00523991|143293854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.219||95.0|-0.2|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.05|-0.20|0.219
71767127|NCT03073733|143036113|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
71767128|NCT03073733|143036114|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
71767129|NCT03073733|143036115|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71767130|NCT03073733|143036116|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 606.4)||||||0.080
71767131|NCT03073733|143036116|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 52.3)||||||0.050
71767132|NCT03073733|143036117|SUPERIORITY|||||||0.099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 35.7)||||||0.099
71767133|NCT03073733|143036117|SUPERIORITY|||||||0.076|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 17.6)||||||0.076
71767134|NCT03073733|143036118|SUPERIORITY|||||||0.1099|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 4.5)||||||0.1099
71767135|NCT03073733|143036118|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|Unpooled t-test (variance ratio of 14.3)||||||0.012
71767136|NCT00167778|143036141|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
71767137|NCT00167778|143036142|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
71767138|NCT00167778|143036143|SUPERIORITY_OR_OTHER||||||=|0.09||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.09
71767139|NCT00167778|143036144|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
71767140|NCT00167778|143036145|SUPERIORITY_OR_OTHER||||||>|0.99||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||>0.99
71713643|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713644|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713645|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713646|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
71713647|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.759||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.759
71713648|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
71713649|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
71713650|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.419||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.419
71713651|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.237
71767141|NCT00167778|143036147|SUPERIORITY_OR_OTHER||||||=|0.8||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.8
71713652|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.146
71767142|NCT00167778|143036148|SUPERIORITY_OR_OTHER||||||=|0.7||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=0.7
71767143|NCT00167778|143036149|SUPERIORITY_OR_OTHER||||||=|0.4||95.0||||Statistical significance was set a-prior at p\<0.05.|Mixed Models Analysis|||||||=.4
71713653|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.113
71713654|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analyaia at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
71713655|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
71713656|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.183
71713657|NCT00402987|142943769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
71713658|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713659|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713660|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713661|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71767144|NCT00167778|143036150|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
71767145|NCT00167778|143036151|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
71767146|NCT00167778|143036152|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
71767147|NCT00167778|143036153|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
71713662|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71886781|NCT00523991|143293855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.518||95.0|-0.1|0.19||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.19|-0.10|0.518
71713663|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713664|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713665|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713666|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713667|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713668|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713669|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713670|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.017
71713671|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.011
71713672|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
71713673|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71713674|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71713675|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71713676|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71713677|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.012
71713678|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.904||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.904
71713679|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.891||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.891
71713680|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.929
71713681|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.994
71886782|NCT00523991|143293856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.455||95.0|-0.09|0.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.21|-0.09|0.455
71886783|NCT00523991|143293857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|-0.16|0.15||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.15|-0.16|0.927
71767148|NCT00167778|143036154|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
71767149|NCT00167778|143036155|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Statistical significance was set a-prior at p\<0.05. Values of p\>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.||||||>0.15
71713682|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.933
71713683|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.876
71713684|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.622
71713685|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
71713686|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.117
71713687|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.152||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.152
71713688|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
71767150|NCT00167778|143036156|SUPERIORITY_OR_OTHER||||||=|0.13||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoon paired signed rank test for the differences between Rigid and Torsion Adapter pylons||||||=0.13
71713689|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
71713690|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
71713691|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.708
71713692|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.106
71713693|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.140
71713694|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.188
71713695|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.239
71713696|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.297
71767151|NCT00167778|143036157|SUPERIORITY_OR_OTHER||||||=|0.92||95.0||||Statistical significance was set a-prior at p\<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between Rigid and Torsion Adapter pylons.||||||=0.92
71827948|NCT00855465|143160139|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||<0.0001
71713697|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.383
71713698|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.919
71767152|NCT00167778|143036158|SUPERIORITY_OR_OTHER||||||=|0.37||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.37
71767153|NCT00167778|143036159|SUPERIORITY_OR_OTHER||||||=|0.27||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.27
71713699|NCT00402987|142943770|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713700|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
71713701|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.697||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.697
71713702|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.203||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.203
71713703|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
71827949|NCT00855465|143160139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.0002|TWO_SIDED|95.0|0.06|0.21||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.21|0.06|0.0002
71827950|NCT00855465|143160139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71827951|NCT00855465|143160140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg Dyspnea Score, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.1220
71827952|NCT00855465|143160140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.76||||0.0165|TWO_SIDED|95.0|-10.45|-1.06||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-1.06|-10.45|0.0165
71886784|NCT00523991|143293858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.933||95.0|-0.17|0.16||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.16|-0.17|0.933
71886785|NCT00523991|143293859|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.996
71713704|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713705|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713706|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713707|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713708|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713709|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71827953|NCT00855465|143160140|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71827954|NCT00855465|143160142|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||||<0.0001
71827955|NCT00855465|143160142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.96|||<|0.0001|TWO_SIDED|95.0|-6.75|-3.16||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-3.16|-6.75|<0.0001
71827956|NCT00855465|143160142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0231|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0231
71827957|NCT00855465|143160143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.62||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|ANCOVA|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.||0.62|0.33|<0.0001
71827958|NCT00855465|143160143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Additional analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71827959|NCT00855465|143160143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.1160
71827960|NCT04365400|143160184|SUPERIORITY||Hodges Lehmann Median|8.24||||0.1148124|TWO_SIDED|95.0|-2.01|18.19|||Wilcoxon (Mann-Whitney)|||||18.19|-2.01|0.1148124
71827961|NCT04365400|143160184|SUPERIORITY||Hodges Lehmann Median|-0.82||||0.8668467|TWO_SIDED|95.0|-10.16|7.96|||Wilcoxon (Mann-Whitney)|||||7.96|-10.16|0.8668467
71827962|NCT04365400|143160185|SUPERIORITY||Difference in Change in HbA1c (%)|0.02516||||0.8658|TWO_SIDED|95.0|-0.26658|0.316897|||ANCOVA|||||0.316897|-0.26658|0.8658
71827963|NCT04365400|143160185|SUPERIORITY||Difference in Change in HbA1c (%)|-0.07333||||0.65|TWO_SIDED|95.0|-0.39012|0.243455|||ANCOVA|||||0.243455|-0.39012|0.6500
71827964|NCT04567888|143160188|SUPERIORITY||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.88|-0.95||Threshold for statistical significance set to .050.|Repeated-measures Multilevel Models|||||-0.95|-1.88|<.001
71886786|NCT00523991|143293860|SUPERIORITY_OR_OTHER|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.196
71713710|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713711|NCT00402987|142943771|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713712|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713713|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71713714|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
71713715|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.046
71713716|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.111
71713717|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.226
71713718|NCT00402987|142943772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.537||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.537
71713719|NCT00402987|142943773|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.01||95.0|1.3|5.5||Treatment as a factor|Regression, Logistic|||||5.5|1.3|0.010
71713720|NCT00402987|142943773|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.003||95.0|1.5|6.4||Treatment as a factor|Regression, Logistic|||||6.4|1.5|0.003
71713721|NCT00402987|142943773|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.634||95.0|0.6|2.2||Treatment as a factor|Regression, Logistic|||||2.2|0.6|0.634
71713722|NCT00402987|142943774|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.63||||0.202||95.0|0.8|3.5||Treatment as a factor|Regression, Logistic|||||3.5|0.8|0.202
71713723|NCT00402987|142943774|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.077||95.0|0.9|5.1||Treatment as a factor|Regression, Logistic|||||5.1|0.9|0.077
71713724|NCT00402987|142943774|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.134||95.0|0.8|4.7||Treatment as a factor|Regression, Logistic|||||4.7|0.8|0.134
71713725|NCT00402987|142943774|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.84||||0.671||95.0|0.4|1.9||Treatment as a factor|Regression, Logistic|||||1.9|0.4|0.671
71713726|NCT00402987|142943774|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.484||95.0|0.3|1.7||Treatment as a factor|Regression, Logistic|||||1.7|0.3|0.484
71713727|NCT00402987|142943774|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||Treatment as a factor|Regression, Logistic|||||2.8|0.4|0.814
71713728|NCT00402987|142943775|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
71713729|NCT00402987|142943775|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
71713730|NCT00402987|142943775|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours||||<0.05
71713731|NCT00402987|142943776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.||||<0.05
71713732|NCT00402987|142943776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours||||<0.05
71713733|NCT00402987|142943777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
71713734|NCT00402987|142943777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours||||<0.05
71713735|NCT00402987|142943778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
71713736|NCT00402987|142943778|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
71713737|NCT00402987|142943778|SUPERIORITY_OR_OTHER_LEGACY|||||||0.889||95.0||||Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.889
71713738|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||<0.001
71713739|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
71713740|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
71713741|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.411
71713742|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.930
71713743|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.438
71713744|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.002
71713745|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.013
71713746|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.015
71713747|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.748
71827965|NCT04567888|143160189|SUPERIORITY||Slope|-0.54|||<|0.001|TWO_SIDED|95.0|-0.78|-0.3||Threshold for statistical significance was set to .050.|Repeated-measures Multilevel Models|||||-0.30|-0.78|< .001
71713748|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.958
71713749|NCT00402987|142943779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747||95.0||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.747
71713750|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.999
71713751|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
71713752|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.076
71713753|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.008
71713754|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713755|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713756|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713757|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71827966|NCT01490580|143160202|SUPERIORITY||Risk Difference (RD)|-6.4||||0.38|TWO_SIDED|95.0|-21.0|8.1|||Mixed Models Analysis|||||8.1|-21.0|0.38
71827967|NCT00716144|143160254|SUPERIORITY_OR_OTHER|||||||0.884|||||||Cochran-Armitage Trend Test|||||||0.884
71713758|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713759|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713760|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713761|NCT00402987|142943780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713762|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.003
71713763|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
71713764|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.043
71713765|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.032
71767154|NCT00167778|143036160|SUPERIORITY_OR_OTHER||||||=|0.2||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.20
71767155|NCT00167778|143036161|SUPERIORITY_OR_OTHER||||||=|0.59||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.59
71767156|NCT00167778|143036162|SUPERIORITY_OR_OTHER||||||=|0.057||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.057
71767157|NCT00167778|143036163|SUPERIORITY_OR_OTHER||||||=|0.78||95.0||||Statistical significance was set a-prior at p\<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.||||||=0.78
71827968|NCT00716144|143160255|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
71713766|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
71713767|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.066
71713768|NCT00402987|142943781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.482
71713769|NCT00402987|142943782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||<|0.001||95.0|0.8|1.9||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.8|<0.001
71713770|NCT00402987|142943782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.002||95.0|0.4|1.5||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.4|0.002
71713771|NCT00402987|142943782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.186||95.0|-1.0|0.2||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.186
71713772|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.961
71713773|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.985||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.985
71713774|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.975||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.975
71713775|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.532
71713776|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.690
71767158|NCT01221272|143036165|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.67||||0.29|TWO_SIDED|95.0|-0.6|1.9||The null hypothesis that ranolazine treatment had no effect on PDS would be rejected if the PDS and TPD p-values were less than 0.05 or the PDS p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.9|-0.6|0.29
71767159|NCT01221272|143036166|SUPERIORITY_OR_OTHER||Mixed Models Analysis|0.65||||0.22|TWO_SIDED|95.0|-0.4|1.7||The null hypothesis that ranolazine treatment had no effect on TPD would be rejected if the PDS and TPD p-values were less than 0.05 or the TPD p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis|||||1.7|-0.4|0.22
71827969|NCT00716144|143160255|SUPERIORITY_OR_OTHER|||||||0.604|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.604
71827970|NCT00716144|143160255|SUPERIORITY_OR_OTHER|||||||0.463|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.463
71713777|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.820
71713778|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.180
71713779|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
71713780|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.693
71713781|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.039
71713782|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.154
71713783|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.521
71713784|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
71713785|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
71713786|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.344
71713787|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713788|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
71767160|NCT04839562|143036179|SUPERIORITY||Mean Difference (Final Values)|-4.3|||=|0.0106|TWO_SIDED|95.0|-7.7|-1.0|||t-test, 2 sided|||||-1|-7.7|=.0106
71713789|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.249
71713790|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713791|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.006
71713792|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.205
71713793|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713794|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71713795|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.186||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.186
71713796|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713797|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713798|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.179||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.179
71767161|NCT04839562|143036180|SUPERIORITY||||||=|0.002|||||||Fisher Exact|||||||=.002
71767162|NCT04839562|143036181|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
71767163|NCT04839562|143036182|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
71767164|NCT04839562|143036183|SUPERIORITY||||||=|0.0348|||||||Fisher Exact|||||||=.0348
71767165|NCT04839562|143036184|SUPERIORITY||||||=|1|||||||Fisher Exact|||||||=1
71767166|NCT04839562|143036185|SUPERIORITY||||||=|0.0173|||||||Fisher Exact|||||||=.0173
71767167|NCT04839562|143036186|SUPERIORITY||||||=|0.1864|||||||Fisher Exact|||||||=.1864
71767168|NCT04839562|143036187|SUPERIORITY||||||=|0.4173|||||||Fisher Exact|||||||=.4173
71767169|NCT04839562|143036188|SUPERIORITY||||||=|0.0343|||||||Fisher Exact|||||||=.0343
71767170|NCT04839562|143036189|SUPERIORITY||||||=|0.0636|||||||Fisher Exact|||||||=.0636
71767171|NCT04839562|143036190|SUPERIORITY||||||=|0.065|||||||Fisher Exact|||||||=.065
71767172|NCT04839562|143036191|SUPERIORITY||||||=|0.1144|||||||Fisher Exact|||||||=.1144
71767173|NCT04839562|143036192|SUPERIORITY||||||=|0.2829|||||||Fisher Exact|||||||=.2829
71767174|NCT00528970|143036198|OTHER||Mean Difference (Final Values)|2.0||||0.944||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.944
71827971|NCT00716144|143160255|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Armitage Trend Test|||At Visit 6||||0.042
71827972|NCT00716144|143160255|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.034
71827973|NCT00716144|143160255|SUPERIORITY_OR_OTHER|||||||0.019|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.019
71886787|NCT00523991|143293861|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.800
71767175|NCT00528970|143036198|OTHER||Mean Difference (Final Values)|9.1||||0.208||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.||||0.208
71827974|NCT00716144|143160257|SUPERIORITY_OR_OTHER|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3||||1.000
71827975|NCT00716144|143160257|SUPERIORITY_OR_OTHER|||||||0.673|||||||Cochran-Armitage Trend Test|||At Visit 4||||0.673
71827976|NCT00716144|143160257|SUPERIORITY_OR_OTHER|||||||0.55|||||||Cochran-Armitage Trend Test|||At Visit 5||||0.550
71827977|NCT00716144|143160257|SUPERIORITY_OR_OTHER|||||||0.721|||||||Cochran-Armitage Trend Test|||At Visit 7||||0.721
71767176|NCT03086967|143036206|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71767177|NCT03086967|143036207|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.133
71767178|NCT03086967|143036208|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71767179|NCT03086967|143036209|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71767180|NCT03086967|143036210|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
71767181|NCT03086967|143036211|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71767182|NCT03086967|143036212|SUPERIORITY|||||||0.98|||||||Chi-squared|||||||0.98
71767183|NCT03086967|143036213|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71767184|NCT03086967|143036214|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71767185|NCT03086967|143036215|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71767186|NCT03086967|143036216|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
71767187|NCT01733212|143036242|EQUIVALENCE|Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.||||||0.07|||||||Chi-squared|||Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.||||0.07
71767188|NCT00775203|143036245|SUPERIORITY_OR_OTHER|||||||0.0119|||||||ANCOVA|ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.||The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.||||0.0119
71767189|NCT04575597|143036262|OTHER|Difference in rates % and associated confidence intervals (CIs) were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-4.1|||||TWO_SIDED|95.0|-12.2|2.5||||||||2.5|-12.2|
71767190|NCT04575597|143036262|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-1.5|||||TWO_SIDED|95.0|-9.9|6.2||||||||6.2|-9.9|
71827978|NCT00716144|143160257|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Armitage Trend Test|||At Visit 8||||0.030
71827979|NCT02950558|143160268|OTHER|||||||0.1269|||||||Wilcoxon (Mann-Whitney)|||||||0.1269
71827980|NCT02950558|143160269|OTHER|||||||0.8808|||||||Wilcoxon (Mann-Whitney)|||||||0.8808
71827981|NCT02950558|143160270|OTHER|||||||0.0382|||||||Wilcoxon (Mann-Whitney)|||||||0.0382
71827982|NCT02950558|143160271|OTHER|||||||0.4696|||||||Wilcoxon (Mann-Whitney)|||||||0.4696
71827983|NCT02950558|143160272|OTHER|||||||0.1818|||||||Fisher Exact|||||||0.1818
71827984|NCT02914522|143160287|SUPERIORITY||Difference in Percentages|10.8||||0.0157|TWO_SIDED|95.0|2.1|19.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.||||19.5|2.1|0.0157
71827985|NCT02914522|143160287|SUPERIORITY||Difference in Percentages|3.8||||0.3379|TWO_SIDED|95.0|-4.3|12.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.0|-4.3|0.3379
71827986|NCT02914522|143160287|SUPERIORITY||Difference in Percentages|7.2||||0.0103|TWO_SIDED|95.0|1.6|12.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||12.8|1.6|0.0103
71886788|NCT00523991|143293862|SUPERIORITY_OR_OTHER|||||||0.215||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.215
71886789|NCT00523991|143293863|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.205
71886790|NCT00523991|143293864|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.622
71713799|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713800|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713801|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.259
71713802|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713803|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713804|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.393||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.393
71713805|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713806|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713807|NCT00402987|142943783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.512
71827987|NCT02914522|143160287|SUPERIORITY||Difference in Percentages|5.2||||0.0645|TWO_SIDED|95.0|0.0|10.5|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.5|-0.0|0.0645
71886791|NCT00523991|143293865|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo||||0.446
71713808|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713809|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713810|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.026
71713811|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.463
71713812|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.131
71713813|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.053
71713814|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713815|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71827988|NCT02914522|143160288|SUPERIORITY||Difference in Percentages|26.0|||<|0.0001|TWO_SIDED|95.0|16.0|35.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.9|16.0|< 0.0001
71827989|NCT02914522|143160288|SUPERIORITY||Difference in Percentages|10.4||||0.042|TWO_SIDED|95.0|0.0|20.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.7|-0.0|0.0420
71886792|NCT00523991|143293867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.819||95.0|-0.05|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.05|0.819
71886793|NCT00523991|143293868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.204||95.0|-0.1|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.02|-0.10|0.204
71886794|NCT00523991|143293869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.67||95.0|-0.08|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.05|-0.08|0.670
71713816|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
71713817|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.484
71713818|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.197
71713819|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.086
71713820|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713821|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713822|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
71713823|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.561
71713824|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.252
71713825|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.136
71827990|NCT02914522|143160289|SUPERIORITY||Difference in Percentages|12.1||||0.0053|TWO_SIDED|95.0|3.8|20.4|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||20.4|3.8|0.0053
71713826|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713827|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713828|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
71713829|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.653
71827991|NCT02914522|143160289|SUPERIORITY||Difference in Percentages|4.6||||0.2295|TWO_SIDED|95.0|-3.1|12.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||12.2|-3.1|0.2295
71827992|NCT02914522|143160289|SUPERIORITY||Difference in Percentages|5.3||||0.0393|TWO_SIDED|95.0|-0.1|10.7|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||10.7|-0.1|0.0393
71656650|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0065|TWO_SIDED|95.0|0.17|1.0||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 24 Months Post-transplant||1.00|0.17|0.0065
71656651|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0845|TWO_SIDED|95.0|-0.04|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 24 Months Post-transplant||0.60|-0.04|0.0845
71656652|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.3742|TWO_SIDED|95.0|-0.06|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 24 Months Post-transplant||0.16|-0.06|0.3742
71656653|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0006|TWO_SIDED|95.0|0.27|0.92||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 24 Months Post-transplant||0.92|0.27|0.0006
71656654|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.1488|TWO_SIDED|95.0|-0.16|1.03||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 36 Months Post-transplant||1.03|-0.16|0.1488
71767191|NCT04575597|143036262|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Differences in Rates %|-1.3|||||TWO_SIDED|95.0|-9.6|6.4||||||||6.4|-9.6|
71767192|NCT04575597|143036262|SUPERIORITY|Difference in rates %, associated CIs, and p-value were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-6.8||||0.0012|TWO_SIDED|95.0|-11.3|-2.4|||Miettinen & Nurminen|||||-2.4|-11.3|0.0012
71767193|NCT04575597|143036265|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.48|1.13||||||||1.13|0.48|
71767194|NCT04575597|143036265|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.46|1.08||||||||1.08|0.46|
71767195|NCT04575597|143036265|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.47|1.11||||||||1.11|0.47|
71886795|NCT00523991|143293870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.63||95.0|-0.09|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.06|-0.09|0.630
71713830|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.287
71713831|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.191||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.191
71713832|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713833|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713834|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.018
71713835|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.741
71767196|NCT04575597|143036265|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||||1.18|0.92|
71767197|NCT04575597|143036266|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.8|2.76||||||||2.76|0.80|
71767198|NCT04575597|143036266|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.69|2.09||||||||2.09|0.69|
71767199|NCT04575597|143036266|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.54|1.62||||||||1.62|0.54|
71767200|NCT04575597|143036266|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.95|1.33||||||||1.33|0.95|
71713836|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.326
71713837|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.256
71713838|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713839|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71767201|NCT04575597|143036267|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.62|1.46||||||||1.46|0.62|
71767202|NCT04575597|143036267|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.75|1.79||||||||1.79|0.75|
71767203|NCT04575597|143036267|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.45|1.07||||||||1.07|0.45|
71767204|NCT04575597|143036267|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.93|1.23||||||||1.23|0.93|
71713840|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.016
71713841|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.808
71713842|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.394||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.394
71713843|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.343
71713844|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71713845|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.029
71713846|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.023
71713847|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.892
71713848|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.952
71713849|NCT00402987|142943784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.948
71713850|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775||95.0||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.775
71713851|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094||95.0||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.094
71713852|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.114||95.0||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.114
71713853|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71713854|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713855|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713856|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713857|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713858|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713859|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713860|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713861|NCT00402987|142943785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713862|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713863|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.002
71713864|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.007
71713865|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
71713866|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.033
71767205|NCT04575597|143036268|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.83||||||||1.83|0.62|
71767206|NCT04575597|143036268|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.4|1.26||||||||1.26|0.40|
71656655|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.546|TWO_SIDED|95.0|-0.33|0.62||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 36 Months Post-transplant||0.62|-0.33|0.5460
71656656|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.7511|TWO_SIDED|95.0|-0.12|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 36 Months Post-transplant||0.16|-0.12|0.7511
71656657|NCT00311311|142831318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.0048|TWO_SIDED|95.0|0.2|1.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 36 Months Post-transplant||1.06|0.20|0.0048
71656658|NCT00311311|142831319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78||||0.1757|TWO_SIDED|95.0|-0.36|1.91||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.91|-0.36|0.1757
71656659|NCT00311311|142831319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0509|TWO_SIDED|95.0|0.0|1.89||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.89|-0.00|0.0509
71656660|NCT00311311|142831319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.11||||0.0683|TWO_SIDED|95.0|-0.09|2.31||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.31|-0.09|0.0683
71656661|NCT00311311|142831320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.47||||0.2741|TWO_SIDED|95.0|-105.79|30.85||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.85|-105.79|0.2741
71656662|NCT00311311|142831320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.97||||0.4865|TWO_SIDED|95.0|-77.48|37.53||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||37.53|-77.48|0.4865
71656663|NCT00311311|142831320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48||||0.9339|TWO_SIDED|95.0|-62.54|57.59||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||57.59|-62.54|0.9339
71656664|NCT00311311|142831321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.4892|TWO_SIDED|95.0|-0.005|0.011||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.011|-0.005|0.4892
71656665|NCT00311311|142831321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.0514|TWO_SIDED|95.0|0.0|0.012||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||0.012|-0.000|0.0514
71656666|NCT00311311|142831321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.009||||0.118|TWO_SIDED|95.0|-0.002|0.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.020|-0.002|0.1180
71656667|NCT00311311|142831322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56||||0.0016|TWO_SIDED|95.0|2.2|8.93||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||8.93|2.20|0.0016
71656668|NCT00311311|142831322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91||||0.0091|TWO_SIDED|95.0|1.01|6.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||6.80|1.01|0.0091
71656669|NCT00311311|142831322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.2468|TWO_SIDED|95.0|-1.6|6.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||6.10|-1.60|0.2468
71713867|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.036
71713868|NCT00402987|142943786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.500
71713869|NCT00402987|142943787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.2|||<|0.001||95.0|8.5|23.8||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.8|8.5|<0.001
71713870|NCT00402987|142943787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.009||95.0|2.6|17.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||17.9|2.6|0.009
71713871|NCT00402987|142943787|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9||||0.127||95.0|-13.5|1.7||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.7|-13.5|0.127
71713872|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.480
71713873|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.780
71713874|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667||95.0||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.667
71713875|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.153
71713876|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.479
71713877|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||95.0||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.469
71767207|NCT04575597|143036268|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.2|0.85||||||||0.85|0.20|
71767208|NCT04575597|143036268|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.86|1.18||||||||1.18|0.86|
71767209|NCT04575597|143036269|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.32|1.34||||||||1.34|0.32|
71767210|NCT04575597|143036269|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.76|2.71||||||||2.71|0.76|
71767211|NCT04575597|143036269|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.39|1.42||||||||1.42|0.39|
71767212|NCT04575597|143036269|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
71713878|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.062
71713879|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.284
71713880|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421||95.0||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.421
71713881|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.022
71767213|NCT04575597|143036270|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.66|1.61||||||||1.61|0.66|
71767214|NCT04575597|143036270|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.83|2.09||||||||2.09|0.83|
71767215|NCT04575597|143036270|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.47|1.23||||||||1.23|0.47|
71886796|NCT00523991|143293871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.704||95.0|-0.1|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo||0.07|-0.10|0.704
71886797|NCT00523991|143293872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.579||95.0|-0.11|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||0.06|-0.11|0.579
71886798|NCT00523991|143293874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.54||||0.916||95.0|-464.02|416.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||416.94|-464.02|0.916
71886799|NCT00523991|143293875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.42||||0.899||95.0|-520.19|457.34||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||457.34|-520.19|0.899
71886800|NCT00523991|143293876|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|181.99||||0.495||95.0|-341.75|705.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||placebo versus tiotropium||705.73|-341.75|0.495
71886801|NCT00523991|143293877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|258.83||||0.318||95.0|-250.37|768.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||768.03|-250.37|0.318
71713882|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.171
71713883|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.354
71713884|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.005
71713885|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
71713886|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.262
71713887|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713888|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.044
71713889|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.194
71713890|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713891|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.020
71713892|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148||95.0||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.148
71886802|NCT00523991|143293878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.18||||0.45||95.0|-338.04|760.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||760.39|-338.04|0.450
71886803|NCT00523991|143293879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.46||||0.858||95.0|-512.2|615.12||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo||615.12|-512.20|0.858
71886804|NCT03439033|143293884|SUPERIORITY||Risk Difference (RD)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||McNemar||Risk difference reflects PSMA PET/MRI Scan detection proportion minus MRI scan detection proportion.|||0.53|0.30|<0.0001
71713893|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71886805|NCT01017952|143293886|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.04|TWO_SIDED|95.0|0.66|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.99|0.66|0.040
71886806|NCT01017952|143293886|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.024|TWO_SIDED|95.0|0.64|0.97|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.97|0.64|0.024
71886807|NCT01017952|143293886|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.85|0.56|<0.001
71713894|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.009
71713895|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.127||95.0||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.127
71713896|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713897|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713898|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.122
71713899|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713900|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713901|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164||95.0||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.164
71713902|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713903|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713904|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.244
71713905|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713906|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713907|NCT00402987|142943788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336||95.0||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.336
71713908|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713909|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713910|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.090
71713911|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.518||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.518
71713912|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.038
71713913|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.019
71886808|NCT01017952|143293887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.177
71886809|NCT01017952|143293887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.036|TWO_SIDED|95.0|0.66|0.99|||Regression, Cox|||||0.99|0.66|0.036
71886810|NCT01017952|143293887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||Regression, Cox|||||0.82|0.54|<0.001
71886811|NCT01017952|143293888|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.154|TWO_SIDED|95.0|0.65|1.07|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.07|0.65|0.154
71713914|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71767216|NCT04575597|143036270|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||||1.16|0.88|
71713915|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713916|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.081||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.081
71713917|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.552
71713918|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.050
71713919|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.027
71713920|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71767217|NCT04575597|143036271|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.41||||||||1.41|0.62|
71713921|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713922|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.071
71713923|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.609
71713924|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.065
71713925|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||95.0||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.042
71713926|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713927|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713928|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.070
71713929|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.689
71713930|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.075
71713931|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.059
71767218|NCT04575597|143036271|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.7|1.69||||||||1.69|0.70|
71767219|NCT04575597|143036271|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
71767220|NCT04575597|143036271|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.01|1.31||||||||1.31|1.01|
71767221|NCT04575597|143036272|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.54|1.69||||||||1.69|0.54|
71886812|NCT01017952|143293888|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.041|TWO_SIDED|95.0|0.6|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.99|0.60|0.041
71827993|NCT02914522|143160289|SUPERIORITY||Difference in Percentages|1.7||||0.5308|TWO_SIDED|95.0|-3.1|6.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||6.6|-3.1|0.5308
71827994|NCT02914522|143160290|SUPERIORITY||Difference in Percentages|8.6||||0.0047|TWO_SIDED|95.0|2.9|14.3|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||14.3|2.9|0.0047
71827995|NCT02914522|143160290|SUPERIORITY||Difference in Percentages|2.1||||0.3495|TWO_SIDED|95.0|-2.6|6.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||6.8|-2.6|0.3495
71886813|NCT01017952|143293888|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.84|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.84|0.51|<0.001
71886814|NCT01017952|143293889|SUPERIORITY_OR_OTHER||Least squares mean difference|0.034||||0.034|TWO_SIDED|95.0|0.003|0.066||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.066|0.003|0.034
71713932|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713933|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713934|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.069
71713935|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.762||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.762
71713936|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.089
71713937|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083||95.0||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.083
71713938|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713939|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||<0.001
71713940|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.064
71713941|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.841
71713942|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.110
71713943|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.119
71713944|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.001
71713945|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.015
71713946|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.087
71827996|NCT02914522|143160290|SUPERIORITY||Difference in Percentages|1.3||||0.4269|TWO_SIDED|95.0|-2.5|5.1|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.1|-2.5|0.4269
71827997|NCT02914522|143160290|SUPERIORITY||Difference in Percentages|0.0||||0.9987|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9987
71827998|NCT02914522|143160291|SUPERIORITY||Difference in Percentages|19.0|||<|0.0001|TWO_SIDED|95.0|9.9|28.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||28.2|9.9|<0.0001
71886815|NCT01017952|143293889|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.143|TWO_SIDED|95.0|-0.008|0.056|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.056|-0.008|0.143
71886816|NCT01017952|143293889|SUPERIORITY_OR_OTHER||Least squares mean difference|0.026||||0.115|TWO_SIDED|95.0|-0.006|0.057|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.057|-0.006|0.115
71713947|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.826
71713948|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.345||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.345
71713949|NCT00402987|142943789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||95.0||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||||0.530
71767222|NCT04575597|143036272|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.61|2.0||||||||2.00|0.61|
71767223|NCT04575597|143036272|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.5|1.38||||||||1.38|0.50|
71767224|NCT04575597|143036272|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.9|1.21||||||||1.21|0.90|
71767225|NCT04575597|143036273|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.77|2.76||||||||2.76|0.77|
71767226|NCT04575597|143036273|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.76|||||TWO_SIDED|95.0|0.92|3.38||||||||3.38|0.92|
71767227|NCT04575597|143036273|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|0.81|2.86||||||||2.86|0.81|
71767228|NCT04575597|143036273|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.89|1.24||||||||1.24|0.89|
71767229|NCT04575597|143036274|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.81|2.2||||||||2.20|0.81|
71767230|NCT04575597|143036274|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.85|2.31||||||||2.31|0.85|
71767231|NCT04575597|143036274|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.57|1.65||||||||1.65|0.57|
71767232|NCT04575597|143036274|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
71767233|NCT04575597|143036275|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.36|1.91||||||||1.91|0.36|
71713950|NCT00402987|142943790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.149||95.0|0.8|3.7|||Regression, Logistic|Treatment as a factor||||3.7|0.8|0.149
71767234|NCT04575597|143036275|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.64|2.97||||||||2.97|0.64|
71767235|NCT04575597|143036275|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.37|2.02||||||||2.02|0.37|
71713951|NCT00402987|142943790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.95||||0.076||95.0|0.9|4.1|||Regression, Logistic|Treatment as a factor||||4.1|0.9|0.076
71713952|NCT00402987|142943790|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.733||95.0|0.6|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.6|0.733
71713953|NCT00402987|142943791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.03||95.0|1.1|5.0|||Regression, Logistic|Treatment as a factor||||5.0|1.1|0.030
71713954|NCT00402987|142943791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.064||95.0|1.0|5.7|||Regression, Logistic|Treatment as a factor||||5.7|1.0|0.064
71713955|NCT00402987|142943791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.201||95.0|0.7|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.7|0.201
71713956|NCT00402987|142943791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.575||95.0|0.5|3.0|||Regression, Logistic|Treatment as a factor||||3.0|0.5|0.575
71767236|NCT04575597|143036275|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.74|1.14||||||||1.14|0.74|
71767237|NCT04575597|143036276|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.44|1.06||||||||1.06|0.44|
71767238|NCT04575597|143036277|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.06|0.67||||||||0.67|0.06|
71767239|NCT04575597|143036277|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.13|0.83||||||||0.83|0.13|
71767240|NCT04575597|143036277|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.79||||||||0.79|0.09|
71713957|NCT00402987|142943791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1||95.0|0.4|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.4|1.000
71713958|NCT00402987|142943791|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3|||Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
71886817|NCT01064167|143293890|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.||||<0.05
71886818|NCT01064167|143293891|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71713959|NCT00402987|142943792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.28|||<|0.001||95.0|0.7|1.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.9|0.7|<0.001
71713960|NCT00402987|142943792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.003||95.0|0.3|1.5||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|0.3|0.003
71713961|NCT00402987|142943792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.177||95.0|-1.0|0.2||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||0.2|-1.0|0.177
71713962|NCT00402987|142943792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.25|||<|0.001||95.0|3.0|7.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||7.5|3.0|<0.001
71713963|NCT00402987|142943792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||<|0.001||95.0|2.3|6.8||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||6.8|2.3|<0.001
71713964|NCT00402987|142943792|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.531||95.0|-3.0|1.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||1.5|-3.0|0.531
71713965|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||<|0.001||95.0|4.4|13.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||13.7|4.4|<0.001
71827999|NCT02914522|143160291|SUPERIORITY||Difference in Percentages|7.8||||0.0672|TWO_SIDED|95.0|-0.7|16.2|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.||||16.2|-0.7|0.0672
71713966|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.46|||<|0.001||95.0|4.7|16.2||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.2|4.7|<0.001
71828000|NCT02914522|143160291|SUPERIORITY||Difference in Percentages|11.4||||0.0019|TWO_SIDED|95.0|4.2|18.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||18.6|4.2|0.0019
71713967|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96||||0.041||95.0|0.2|11.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.7|0.2|0.041
71713968|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39||||0.633||95.0|-7.1|4.3||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||4.3|-7.1|0.633
71713969|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.11||||0.284||95.0|-2.6|8.8||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||8.8|-2.6|0.284
71713970|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.18||95.0|-2.1|11.1||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.1|-2.1|0.180
71828001|NCT02914522|143160291|SUPERIORITY||Difference in Percentages|5.2||||0.1286|TWO_SIDED|95.0|-1.4|11.8|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||11.8|-1.4|0.1286
71828002|NCT02914522|143160292|SUPERIORITY||Difference in Percentages|7.9||||0.0105|TWO_SIDED|95.0|1.9|13.8|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||13.8|1.9|0.0105
71828003|NCT02914522|143160292|SUPERIORITY||Difference in Percentages|4.3||||0.1062|TWO_SIDED|95.0|-1.0|9.6|||Cochran-Mantel-Haenszel|CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1||||9.6|-1.0|0.1062
71828004|NCT02914522|143160292|SUPERIORITY||Difference in Percentages|1.7||||0.3084|TWO_SIDED|95.0|-2.2|5.6|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||5.6|-2.2|0.3084
71828005|NCT02914522|143160292|SUPERIORITY||Difference in Percentages|0.0||||0.9109|TWO_SIDED|95.0|-3.4|3.4|||Cochran-Mantel-Haenszel|CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,\>1).||||3.4|-3.4|0.9109
71828006|NCT02914522|143160298|SUPERIORITY||Difference in Percentages|25.5|||<|0.0001|TWO_SIDED|95.0|16.0|35.0|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.0|16.0|<0.0001
71828007|NCT02914522|143160298|SUPERIORITY||Difference in Percentages|9.2||||0.0658|TWO_SIDED|95.0|-1.1|19.5|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||19.5|-1.1|0.0658
71828008|NCT02914522|143160299|SUPERIORITY||Difference in Percentages|13.0||||0.0024|TWO_SIDED|95.0|5.3|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|5.3|0.0024
71828009|NCT02914522|143160299|SUPERIORITY||Difference in Percentages|0.9||||0.7951|TWO_SIDED|95.0|-7.0|8.7|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||8.7|-7.0|0.7951
71828010|NCT02914522|143160300|SUPERIORITY||Difference in Percentages|20.8||||0.0055|TWO_SIDED|95.0|7.7|33.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||33.9|7.7|0.0055
71886819|NCT01128829|143293906|SUPERIORITY_OR_OTHER|||||||0.025|||||||t-test, 2 sided|||Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).||||0.025
71886820|NCT02302963|143293907|OTHER|Analysis of Variance|||||<|0.001|||||||GLM Repeated Measures|Repeated-measures general linear model was used to compare HCLC versus SAP data. A P-value of \< 0.001 was considered the threshold for significance.||||||<0.001
71886821|NCT01724528|143293915|SUPERIORITY_OR_OTHER||Least squares means difference|-196.794|||<|0.0001|TWO_SIDED|95.0|-238.6|-154.988|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||-154.988|-238.600|<0.0001
71656670|NCT00311311|142831323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.5282|TWO_SIDED|95.0|-2.05|3.94||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||3.94|-2.05|0.5282
71656671|NCT00311311|142831323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.5057|TWO_SIDED|95.0|-2.53|5.07||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||5.07|-2.53|0.5057
71656672|NCT00311311|142831323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.5701|TWO_SIDED|95.0|-4.0|7.18||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||7.18|-4.00|0.5701
71656673|NCT00311311|142831325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.028|TWO_SIDED|95.0|0.03|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||12 months post-transplant||0.48|0.03|0.0280
71656674|NCT00311311|142831325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.019|TWO_SIDED|95.0|0.04|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||24 months post-transplant||0.48|0.04|0.0190
71656675|NCT00311311|142831325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.1182|TWO_SIDED|95.0|-0.07|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||36 months post-transplant||0.60|-0.07|0.1182
71656676|NCT00311311|142831326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7361|TWO_SIDED|95.0|-2.09|1.49||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||1.49|-2.09|0.7361
71656677|NCT00311311|142831326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.5549|TWO_SIDED|95.0|-2.32|1.26||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.26|-2.32|0.5549
71656678|NCT00311311|142831326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.6058|TWO_SIDED|95.0|-3.69|2.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||2.17|-3.69|0.6058
71656679|NCT00311311|142831327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5902|TWO_SIDED|95.0|-1.63|2.84||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||2.84|-1.63|0.5902
71656680|NCT00311311|142831327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.7536|TWO_SIDED|95.0|-2.68|1.95||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||1.95|-2.68|0.7536
71713971|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.57||||0.009||95.0|3.4|23.7||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||23.7|3.4|0.009
71713972|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.15||||0.026||95.0|1.7|26.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||26.6|1.7|0.026
71713973|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.39||||0.138||95.0|-3.0|21.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||21.8|-3.0|0.138
71713974|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.926||95.0|-13.0|11.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||11.8|-13.0|0.926
71713975|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18||||0.507||95.0|-8.2|16.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||16.6|-8.2|0.507
71713976|NCT00402987|142943793|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77||||0.513||95.0|-9.6|19.1||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||||19.1|-9.6|0.513
71713977|NCT00402987|142943794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.93||||0.023||95.0|1.2|7.4|||Regression, Logistic|Treatment as a factor||||7.4|1.2|0.023
71713978|NCT00402987|142943794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.13||||0.015||95.0|1.2|7.9|||Regression, Logistic|Treatment as a factor||||7.9|1.2|0.015
71713979|NCT00402987|142943794|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.854||95.0|0.5|2.2|||Regression, Logistic|Treatment as a factor||||2.2|0.5|0.854
71713980|NCT00402987|142943795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.46||||0.013||95.0|1.3|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.3|0.013
71713981|NCT00402987|142943795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.03||||0.003||95.0|1.7|14.5|||Regression, Logistic|Treatment as a factor||||14.5|1.7|0.003
71713982|NCT00402987|142943795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.99||||0.057||95.0|1.0|9.2|||Regression, Logistic|Treatment as a factor||||9.2|1.0|0.057
71713983|NCT00402987|142943795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.758||95.0|0.5|2.9|||Regression, Logistic|Treatment as a factor||||2.9|0.5|0.758
71713984|NCT00402987|142943795|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.69||||0.381||95.0|0.3|1.6|||Regression, Logistic|Treatment as a factor||||1.6|0.3|0.381
71713985|NCT00402987|142943795|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.68||||0.313||95.0|0.6|4.6|||Regression, Logistic|Treatment as a factor||||4.6|0.6|0.313
71713986|NCT00402987|142943796|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|8.2||||||95.0|4.5|46.4||||||NNT is the inverse of the absolute risk reduction at 6 hours||46.4|4.5|
71713987|NCT00402987|142943796|SUPERIORITY_OR_OTHER_LEGACY||NNT at 6 hours|7.5||||||95.0|4.3|32.0||||||NNT is the inverse of the absolute risk reduction at 6 hours||32.0|4.3|
71713988|NCT00402987|142943797|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|7.5||||||95.0|4.3|28.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||28.7|4.3|
71713989|NCT00402987|142943797|SUPERIORITY_OR_OTHER_LEGACY||NNT at 12 hours|5.0||||||95.0|3.0|16.7||||||NNT is the inverse of the absolute risk reduction at 12 hours||16.7|3.0|
71713990|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.77|||<|0.001||95.0|1.9|7.6||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.6|1.9|<0.001
71713991|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.72||||0.005||95.0|1.3|5.5||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.5|1.3|0.005
71713992|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72||||0.286||95.0|0.4|1.3||Analysis for 2 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.3|0.4|0.286
71713993|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.37||||0.001||95.0|1.6|7.1||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||7.1|1.6|0.001
71767241|NCT04575597|143036277|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||||||||1.36|0.87|
71767242|NCT04575597|143036278|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.23||||||||2.23|0.74|
71767243|NCT04575597|143036278|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.45|1.8||||||||1.80|0.45|
71767244|NCT04575597|143036278|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.55|1.89||||||||1.89|0.55|
71828011|NCT02914522|143160300|SUPERIORITY||Difference in Percentages|8.2||||0.1265|TWO_SIDED|95.0|-4.2|20.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||20.6|-4.2|0.1265
71828012|NCT02914522|143160301|SUPERIORITY||Difference in Percentages|9.5||||0.0157|TWO_SIDED|95.0|1.8|17.1|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||17.1|1.8|0.0157
71828013|NCT02914522|143160301|SUPERIORITY||Difference in Percentages|5.5||||0.1808|TWO_SIDED|95.0|-2.9|13.9|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||13.9|-2.9|0.1808
71713994|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.004||95.0|1.4|6.5||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.5|1.4|0.004
71713995|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9||||0.752||95.0|0.5|1.7||Analysis for 6 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||1.7|0.5|0.752
71713996|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.57|||<|0.001||95.0|1.9|10.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||10.7|1.9|<0.001
71828014|NCT02914522|143160302|SUPERIORITY||Difference in Percentages|24.9|||<|0.0001|TWO_SIDED|95.0|14.6|35.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||35.2|14.6|<0.0001
71828015|NCT02914522|143160302|SUPERIORITY||Difference in Percentages|9.9||||0.0521|TWO_SIDED|95.0|-1.3|21.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||21.2|-1.3|0.0521
71828016|NCT02914522|143160303|SUPERIORITY||Difference in Percentages|16.0||||0.0005|TWO_SIDED|95.0|7.8|24.2|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||24.2|7.8|0.0005
71828017|NCT02914522|143160303|SUPERIORITY||Difference in Percentages|4.3||||0.2946|TWO_SIDED|95.0|-3.9|12.6|||Cochran-Mantel-Haenszel|CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).||||12.6|-3.9|0.2946
71828018|NCT00392678|143160313|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71828019|NCT00387465|143160330|OTHER|The maximum tolerated dose (MTD) was derived from the number of participants experiencing dose-limiting toxicities in the Phase I arms. The MTD was the dose at which ≤30% of patients experienced DLTs during cycle 1 up to a pre-specified maximal dose of 40 mg/m2 of azacitidine.|Maximum Tolerated Dose|40.0|||||TWO_SIDED||||||||MTD of Azacitidine measured in mg/m\^2|||||
71828020|NCT05012644|143160348|OTHER||Odds Ratio (OR)|1.266|||||TWO_SIDED|95.0|0.715|2.241||||||||2.241|0.715|
71828021|NCT05012644|143160349|OTHER||Odds Ratio (OR)|1.508|||||TWO_SIDED|95.0|0.819|2.774||||||||2.774|0.819|
71886822|NCT01724528|143293916|SUPERIORITY_OR_OTHER||Least squares means difference|4.097||||0.0903|TWO_SIDED|95.0|-0.6467|8.8406|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and \> 7.5 mg/dL) were inserted in the ANCOVA model as covariates||8.8406|-0.6467|0.0903
71713997|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.68||||0.003||95.0|1.6|8.7||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.7|1.6|0.003
71828022|NCT00482729|143160374|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||<|0.001||95.0|-0.78|-0.43|||ANCOVA|Model terms: treatment, baseline A1C||||-0.43|-0.78|<0.001
71828023|NCT00482729|143160375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07|||<|0.001||95.0|1.6|2.69||Based on a test of the odds ratio = 1, comparing the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|ANCOVA|Model terms: treatment, baseline A1C|This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|||2.69|1.60|<0.001
71828024|NCT00482729|143160376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||<|0.001||95.0|-22.4|-9.0|||ANCOVA|Model terms: treatment, baseline A1C||||-9.0|-22.4|<0.001
71828025|NCT00482729|143160377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||||95.0|-0.67|-0.3|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.|||-0.30|-0.67|
71828026|NCT00482729|143160378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||||95.0|1.63|2.73|||||This parameter estimate and 95% confidence interval correspond to the odds of having A1C \<7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C|||2.73|1.63|
71828027|NCT01606124|143160379|SUPERIORITY|||||||0.5631|||||||Wilcoxon (Mann-Whitney)|||||||0.5631
71828028|NCT01606124|143160380|SUPERIORITY|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||||||0.1439
71828029|NCT01192542|143160422|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0064|||TWO_SIDED|95.0|-0.022|0.003|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.|The mean difference is calculated as: Test lens - Control lens.|The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.003|-0.022|
71886823|NCT01724528|143293917|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0231||||0.1993|TWO_SIDED|95.0|-0.0153|0.0654|||Wilson's confidence interval|||||0.0654|-0.0153|0.1993
71886824|NCT01724528|143293918|SUPERIORITY_OR_OTHER||Relative risk|0.875||||0.8488|TWO_SIDED|95.0|0.4408|1.7369|||Chi-squared|||||1.7369|0.4408|0.8488
71713998|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.511||95.0|0.4|1.5||Analysis for 2 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.5|0.4|0.511
71713999|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.05||||0.009||95.0|1.3|7.0||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||7.0|1.3|0.009
71828030|NCT01192542|143160425|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0091|||TWO_SIDED|95.0|-0.018|0.018|||Mixed Models Analysis|Comparisons between two lenses were carried out using 95% confidence intervals (CI) constructed for least-square mean differences.||The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.||0.018|-0.018|
71828031|NCT00355914|143160426|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||compared baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
71828032|NCT00355914|143160427|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||baseline, 3, 6, 12, 18, and 24 months between groups||||>0.05
71828033|NCT00964366|143160476|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Dunn's Multiple Comparisons Test|||||||> 0.05
71886825|NCT01724528|143293919|SUPERIORITY_OR_OTHER||Relative risk|0.994||||1|TWO_SIDED|95.0|0.9691|1.0199|||Chi-squared|||||1.0199|0.9691|1.0000
71767245|NCT04575597|143036278|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.37||||||||1.37|0.94|
71886826|NCT01634555|143293936|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.93|||||TWO_SIDED|90.0|0.83|1.05|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Irinotecan .||||1.05|0.83|
71714000|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
71767246|NCT04575597|143036279|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.83|2.33||||||||2.33|0.83|
71767247|NCT04575597|143036279|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.5|1.48||||||||1.48|0.50|
71714001|NCT00402987|142943798|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.863||95.0|0.5|1.9||Analysis for 6 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||1.9|0.5|0.863
71714002|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.92||||0.004||95.0|1.4|6.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||6.1|1.4|0.004
71714003|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.052||95.0|1.0|5.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.7|1.0|0.052
71714004|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.095||95.0|0.9|5.1||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||5.1|0.9|0.095
71714005|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.431||95.0|0.6|3.0||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||3.0|0.6|0.431
71714006|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.602||95.0|0.6|2.7||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.7|0.6|0.602
71767248|NCT04575597|143036279|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.56|1.72||||||||1.72|0.56|
71767249|NCT04575597|143036279|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|1.01|1.43||||||||1.43|1.01|
71767250|NCT04575597|143036280|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.19||||||||2.19|0.29|
71886827|NCT01634555|143293936|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.95|||||TWO_SIDED|90.0|0.88|1.04|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.04|0.88|
71886828|NCT01634555|143293938|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|1.04|||||TWO_SIDED|90.0|0.97|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Irinotecan.||||1.12|0.97|
71886829|NCT01634555|143293938|SUPERIORITY_OR_OTHER||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.85|1.12|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1 for Metabolite SN-38.||||1.12|0.85|
71714007|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||12 hours \>=35% gone|Regression, Logistic|Treatment as a factor||||2.8|0.4|0.814
71714008|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.7|1.2|0.014
71714009|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.23||||0.016||95.0|1.2|8.4||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||8.4|1.2|0.016
71714010|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.063||95.0|0.9|6.8||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||6.8|0.9|0.063
71714011|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.775||95.0|0.5|2.7||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.7|0.5|0.775
71714012|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.779||95.0|0.4|2.0||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||2.0|0.4|0.779
71714013|NCT00402987|142943799|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3||12 hours \>=50% gone|Regression, Logistic|Treatment as a factor||||3.3|0.5|0.624
71714014|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.001
71714015|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.012
71714016|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453||95.0||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor||||||0.453
71714017|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||<0.001
71714018|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
71714019|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||95.0||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor||||||0.814
71714020|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.024
71714021|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.022
71767251|NCT04575597|143036280|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.34|2.44||||||||2.44|0.34|
71767252|NCT04575597|143036280|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.77|||||TWO_SIDED|95.0|0.74|4.23||||||||4.23|0.74|
71767253|NCT04575597|143036280|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.04||||||||1.04|0.67|
71714022|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.966||95.0||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor||||||0.966
71714023|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
71714024|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.001
71714025|NCT00402987|142943800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.798||95.0||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor||||||0.798
71714026|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
71714027|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||<0.001
71714028|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.008
71714029|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.709
71767254|NCT04575597|143036281|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|2.52|||||TWO_SIDED|95.0|0.98|6.53||||||||6.53|0.98|
71767255|NCT04575597|143036281|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.23|2.52||||||||2.52|0.23|
71767256|NCT04575597|143036281|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.11|1.84||||||||1.84|0.11|
71767257|NCT04575597|143036281|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.16||||||||1.16|0.66|
71828034|NCT00964366|143160478|SUPERIORITY_OR_OTHER||||||<|0.05||||||Dapsone versus Clindamycin/BPO gel.|Dunn's Multiple Comparisons Test|||||||< 0.05
71828035|NCT00964366|143160479|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71828036|NCT00964366|143160480|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71714030|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.331
71714031|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246||95.0||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor||||||0.246
71714032|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.001
71714033|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||<0.001
71714034|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.219
71714035|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.095
71714036|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.463
71714037|NCT00402987|142943801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor||||||0.038
71714038|NCT00402987|142943802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
71714039|NCT00402987|142943802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Regression, Logistic|Treatment as a factor||||||0.008
71714040|NCT00402987|142943802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||Regression, Logistic|Treatment as a factor||||||0.557
71714041|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||<0.001
71714042|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.002
71714043|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.036
71714044|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.339
71714045|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||1.000
71714046|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401||95.0||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor||||||0.401
71714047|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.003
71714048|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.002
71714049|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.223
71714050|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.198
71714051|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.604
71714052|NCT00402987|142943803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||95.0||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor||||||0.117
71767258|NCT04575597|143036282|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.46|3.32||||||||3.32|0.46|
71767259|NCT04575597|143036282|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.54|3.74||||||||3.74|0.54|
71714053|NCT00402987|142943806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||0.001
71714054|NCT00402987|142943806|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Logistic|Treatment as a factor||||||<0.001
71714055|NCT00402987|142943806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Regression, Logistic|Treatment as a factor||||||0.025
71714056|NCT00402987|142943806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||95.0|||||Regression, Logistic|Treatment as a factor||||||0.539
71714057|NCT00402987|142943806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Regression, Logistic|Treatment as a factor||||||0.329
71714058|NCT00402987|142943806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Regression, Logistic|Treatment as a factor||||||0.171
71714059|NCT00402987|142943807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Regression, Logistic|Treatment as a factor||||||0.007
71714060|NCT00402987|142943807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Regression, Logistic|Treatment as a factor||||||0.244
71714061|NCT00402987|142943807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0|||||Regression, Logistic|Treatment as a factor||||||0.096
71714062|NCT00402987|142943807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579||95.0|||||Regression, Logistic|Treatment as a factor||||||0.579
71714063|NCT00402987|142943807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||95.0|||||Regression, Logistic|Treatment as a factor||||||0.277
71714064|NCT00402987|142943807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.649||95.0|||||Regression, Logistic|Treatment as a factor||||||0.649
71714065|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|||<|0.001||95.0|7.5|23.2||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||23.2|7.5|<0.001
71714066|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.4||||0.003||95.0|4.9|24.0||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||24.0|4.9|0.003
71714067|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.2||||0.096||95.0|-1.5|17.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.8|-1.5|0.096
71714068|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.141||95.0|-2.4|16.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||16.8|-2.4|0.141
71714069|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.849||95.0|-8.6|10.5||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||10.5|-8.6|0.849
71714070|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3||||0.266||95.0|-4.8|17.4||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect||||17.4|-4.8|0.266
71714071|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.141||95.0|-5.4|0.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||0.8|-5.4|0.141
71714072|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.312||95.0|-5.7|1.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||1.8|-5.7|0.312
71714073|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.724||95.0|-4.5|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-4.5|0.724
71714074|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.398||95.0|-5.4|2.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||2.1|-5.4|0.398
71714075|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.846||95.0|-4.1|3.4||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.4|-4.1|0.846
71714076|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.572||95.0|-5.6|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect||||3.1|-5.6|0.572
71714077|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.014||95.0|1.2|10.4||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.4|1.2|0.014
71714078|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.573||95.0|-4.0|7.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||7.2|-4.0|0.573
71714079|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.482||95.0|-7.7|3.6||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||3.6|-7.7|0.482
71714080|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.007||95.0|2.2|13.5||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||13.5|2.2|0.007
71714081|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.2||||0.143||95.0|-1.4|9.8||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||9.8|-1.4|0.143
71714082|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.6||||0.273||95.0|-2.9|10.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect||||10.2|-2.9|0.273
71714083|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0||||0.003||95.0|4.4|21.6||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||21.6|4.4|0.003
71714084|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.7||||0.029||95.0|1.2|22.2||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||22.2|1.2|0.029
71714085|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2||||0.251||95.0|-4.4|16.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||16.8|-4.4|0.251
71714086|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8||||0.204||95.0|-3.7|17.4||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.4|-3.7|0.204
71714087|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.808||95.0|-9.2|11.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||11.8|-9.2|0.808
71714088|NCT00402987|142943808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.5||||0.371||95.0|-6.6|17.7||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect||||17.7|-6.6|0.371
71828037|NCT02393716|143160488|OTHER|Single arm study with a hypothesis test comparing to performance goal|Percentage|2.9|||<|0.001|ONE_SIDED|97.5||7.2|||Based on exact binomial distribution|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a MAE within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 20% is the safety PG."||7.2||<0.001
71714089|NCT00402987|142943809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||<0.001
71828038|NCT02393716|143160489|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|95.8|||<|0.001|ONE_SIDED|97.5|90.4||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||90.4|<0.001
71828039|NCT02957539|143160503|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|97.5|-10.7|1.6|||||Change in weight from baseline to week 32 in the financial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||1.6|-10.7|
71886830|NCT01299766|143293984|SUPERIORITY||Risk Ratio (RR)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.74|||Poisson regression with robust SE (GEE)|||Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.||0.74|0.02|.02
71886831|NCT01299766|143293985|SUPERIORITY||Difference in Slopes|2.47||||0.064|TWO_SIDED|95.0|-0.14|5.07|||Mixed Models Analysis|||Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.||5.07|-.14|.064
71714090|NCT00402987|142943809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.002
71714091|NCT00402987|142943809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.235
71714092|NCT00402987|142943809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.012
71714093|NCT00402987|142943809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.438||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.438
71714094|NCT00402987|142943809|SUPERIORITY_OR_OTHER_LEGACY|||||||0.067||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.067
71714095|NCT00402987|142943810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.128
71714096|NCT00402987|142943810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.123
71714097|NCT00402987|142943810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.266||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.266
71714098|NCT00402987|142943810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.849||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.849
71714099|NCT00402987|142943810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.828||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.828
71714100|NCT00402987|142943810|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel|||||||0.741
71714101|NCT05528770|142943811|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|8.98||0.4291|TWO_SIDED|95.0|-3.8|8.3|||t-test, 2 sided|||||8.3|-3.8|0.4291
71714102|NCT03229538|142943826|OTHER||Adjusted Odds Ratio|0.86||||0.14|TWO_SIDED|95.0|0.71|1.05|||Regression, Logistic|||||1.05|0.71|0.14
71714103|NCT03229538|142943826|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-2.6|0.9|||||Difference = Methylprednisolone - Placebo|Rank = 97||0.9|-2.6|
71714104|NCT03229538|142943826|OTHER||Percent Difference|-1.5|||||TWO_SIDED|95.0|-3.5|0.5|||||Difference = Methylprednisolone - Placebo|Rank \> or = 96||0.5|-3.5|
71714105|NCT03229538|142943826|OTHER||Percent Difference|-2.2|||||TWO_SIDED|95.0|-4.4|0.1|||||Difference = Methylprednisolone - Placebo|Rank \> or = 95||0.1|-4.4|
71714106|NCT03229538|142943826|OTHER||Percent Difference|-0.8|||||TWO_SIDED|95.0|-4.3|2.7|||||Difference = Methylprednisolone - Placebo|Rank \> or = 94||2.7|-4.3|
71714107|NCT03229538|142943826|OTHER||Percent Difference|-3.8|||||TWO_SIDED|95.0|-7.8|0.2|||||Difference = Methylprednisolone - Placebo|Rank \> or = 93||0.2|-7.8|
71714108|NCT03229538|142943826|OTHER||Percent Difference|-3.4|||||TWO_SIDED|95.0|-7.8|0.9|||||Difference = Methylprednisolone - Placebo|Rank \> or = 92||0.9|-7.8|
71714109|NCT03229538|142943826|OTHER||Percent Difference|-3.1|||||TWO_SIDED|95.0|-7.5|1.3|||||Difference = Methylprednisolone - Placebo|Rank \> or = 91||1.3|-7.5|
71714110|NCT03229538|142943827|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.74||||0.428|TWO_SIDED|95.0|0.34|1.57|||Regression, Logistic|||||1.57|0.34|0.428
71714111|NCT03229538|142943828|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone.|Adjusted Odds Ratio|0.83||||0.228|TWO_SIDED|95.0|0.61|1.13|||Regression, Logistic|||||1.13|0.61|0.228
71714112|NCT03229538|142943829|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-4.0|0.4||||||||0.4|-4.0|
71714113|NCT03229538|142943830|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.79||||0.309|TWO_SIDED|95.0|0.5|1.25|||Regression, Logistic|||||1.25|0.50|0.309
71714114|NCT03229538|142943831|SUPERIORITY|It was estimated that 1200 patients (600 per trial group) would provide the trial with more than 90% power to detect superiority of methylprednisolone over placebo.|Adjusted Odds Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.57|||Regression, Logistic|||||1.57|0.52|0.723
71714115|NCT03229538|142943833|SUPERIORITY||Adjusted Odds Ratio|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||Regression, Logistic|||||1.11|0.67|0.256
71714116|NCT00862940|142943911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|1.3||0.9754|TWO_SIDED|95.0|-2.6|2.52|||Mixed Models Analysis|||Linear mixed model relating direct change in brain volume (BBSI) to time and its interaction with treatment group. This model additionally includes a time-by-AChEI group interaction as a fixed effect.||2.52|-2.60|0.9754
71714117|NCT00862940|142943912|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.5|STANDARD_ERROR_OF_MEAN|17.52||0.842|TWO_SIDED|95.0|-38.04|31.04|||MMRM|||Mixed model repeated measurements (MMRM) with unstructured covariance including time, time-by-treatment, visit, pre-treatment HCV, and AChEI group.||31.04|-38.04|0.842
71714118|NCT00862940|142943913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|0.79||0.034|TWO_SIDED|95.0|0.13|3.23||The p-value represents the difference from placebo for COWAT at Week 52 (MMRM).|MMRM|||||3.23|0.13|0.034
71714119|NCT00862940|142943914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.46||0.602|TWO_SIDED|95.0|-0.67|1.15||The p-value represents the difference from placebo for MMSE at Week 52 (MMRM).|MMRM|||||1.15|-0.67|0.602
71714120|NCT04533646|142943945|OTHER||Mean Difference (Net)|1.1|||<|0.01|TWO_SIDED||||||Means testing||||comparison of means test was performed|||<0.01
71714121|NCT02581930|142943953|OTHER|Exact binomial test|Probability of response|0.0||||1|ONE_SIDED|||||Significant if p-value is less than 0.1|Exact binomial test, 1-sided||Estimated as proportion of subjects with response|The primary comparison was between the response rate of an ineffective drug, such as investigators' choice chemotherapy (5%), and the response rate of ibrutinib.||||1.00
71738988|NCT00620113|142990733|SUPERIORITY_OR_OTHER||Difference in LS Means|-44.32|||<|0.001|TWO_SIDED|95.0|-60.42|-28.21||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-28.21|-60.42|<0.001
71738989|NCT00620113|142990733|SUPERIORITY_OR_OTHER||Difference in LS Means|-35.75|||<|0.001|TWO_SIDED|95.0|-52.33|-19.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-19.16|-52.33|<0.001
71738990|NCT00620113|142990734|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.42|||<|0.001|TWO_SIDED|95.0|-85.7|-35.13||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.13|-85.70|<0.001
71738991|NCT00620113|142990734|SUPERIORITY_OR_OTHER||Difference in LS Means|-60.7|||<|0.001|TWO_SIDED|95.0|-85.91|-35.49||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-35.49|-85.91|<0.001
71738992|NCT00620113|142990734|SUPERIORITY_OR_OTHER||Difference in LS Means|-38.73|||<|0.001|TWO_SIDED|95.0|-65.94|-11.52||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-11.52|-65.94|<0.001
71767260|NCT04575597|143036282|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.34|2.76||||||||2.76|0.34|
71714122|NCT02369536|142943984|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
71714123|NCT02369536|142943987|SUPERIORITY||||||<|0.05|||||||ANOVA|||Intention-to-treat-analysis. Differences between basal values in active and control groups and between T1 vsT0 changes in the two groups assessed by ANOVA and Fisher's exact test.||||<0.05
71714124|NCT02410772|142943992|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|1.0||||0.05|TWO_SIDED|95.0|-2.6|4.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||4.5|-2.6|0.05
71828040|NCT02957539|143160503|SUPERIORITY||Mean Difference (Net)|-5.0|||<|0.025|TWO_SIDED|97.5|-11.1|1.0|||t-test, 2 sided||Change in weight from baseline to week 32 in the non-financial arm minus the change in weight from baseline to week 32 in the no rewards arm|||1|-11.1|<0.025
71828041|NCT02957539|143160504|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.5|1.8|||||Change in Self Efficacy score from baseline to week 16 in the financial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.8|-0.5|
71828042|NCT02957539|143160504|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-0.8|1.5|||||Change in Self Efficacy score from baseline to week 16 in the nonfinancial rewards arm minus the change in Self Efficacy score from baseline to week 16 in the no rewards arm.|||1.5|-0.8|
71828043|NCT02957539|143160505|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|97.5|-1.2|1.4|||||The change in self efficacy from baseline to week 32 in the financial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.4|-1.2|
71828044|NCT02957539|143160505|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.9|1.8|||||The change in self efficacy from baseline to week 32 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 32 in the no rewards arm|||1.8|-.9|
71828045|NCT02957539|143160506|SUPERIORITY||Mean Difference (Net)|1.5|||||TWO_SIDED|97.5|0.2|2.8|||||The change in self efficacy from baseline to week 52 in the financial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.8|0.2|
71828046|NCT02957539|143160506|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|97.5|0.0|2.3|||||The change in self efficacy from baseline to week 52 in the nonfinancial incentive arm minus the change in self efficacy from baseline to week 52 in the no rewards arm|||2.3|0.0|
71714125|NCT02410772|142943992|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|3.0||||0.05|TWO_SIDED|95.0|-0.6|6.6|||Cochran-Mantel-Haenszel|For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||6.6|-0.6|0.05
71828047|NCT02957539|143160507|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|97.5|-0.4|0.9|||||Change in intrinsic motivation score from baseline to week 16 in the financial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.9|-0.4|
71828048|NCT02957539|143160507|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|97.5|-0.6|0.7|||||Change in intrinsic motivation score from baseline to week 16 in the nonfinancial rewards arm minus the change in intrinsic motivation score from baseline to week 16 in the no rewards arm.|||0.7|-0.6|
71828049|NCT02957539|143160508|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|97.5|-0.2|1.3|||||The change in intrinsic motivation from baseline to week 32 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.3|-0.2|
71828050|NCT02957539|143160508|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|97.5|-0.3|1.6|||||The change in intrinsic motivation from baseline to week 32 in the nonfinancial incentive arm minus the change in intrinsic motivation from baseline to week 32 in the no rewards arm|||1.6|-0.3|
71828051|NCT02957539|143160509|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|97.5|-0.5|1.5|||||The change in intrinsic motivation from baseline to week 52 in the financial incentive arm minus the change in intrinsic motivation from baseline to week 52 in the no rewards arm|||1.5|-0.5|
71828052|NCT02957539|143160509|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|97.5|-0.8|1.6|||||Incentive Group minus usual care|||1.6|-0.8|
71828053|NCT02957539|143160510|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.0|2.6|||||Change in PHQ-8 score from baseline to week 16 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 16 in the no rewards arm.|||2.6|-2.0|
71828054|NCT02957539|143160510|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|97.5|-1.5|2.9|||||Change in PHQ-9 from week baseline to week 16 in the non-financial incentive group minus the change from week baseline to week 16 in the no rewards group|||2.9|-1.5|
71828055|NCT02957539|143160511|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|97.5|-1.7|4.5|||||The change in PHQ-8 from baseline to week 32 in the financial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||4.5|-1.7|
71714126|NCT02410772|142943993|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|2.0||||0.05|TWO_SIDED|95.0|-1.1|5.1||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||5.1|-1.1|0.05
71714127|NCT02410772|142943993|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than , then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|4.4||||0.05|TWO_SIDED|95.0|1.2|7.7||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a|Cochran-Mantel-Haenszel|||For primary efficacy endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||7.7|1.2|0.05
71738993|NCT00620113|142990735|SUPERIORITY_OR_OTHER||Difference in LS Means|-42.91|||<|0.001|TWO_SIDED|95.0|-65.55|-20.27||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-20.27|-65.55|<0.001
71767261|NCT04575597|143036282|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.66|1.1||||||||1.10|0.66|
71767262|NCT04575597|143036283|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.41|2.52||||||||2.52|0.41|
71767263|NCT04575597|143036283|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.26|1.9||||||||1.90|0.26|
71767264|NCT04575597|143036283|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.51|3.0||||||||3.00|0.51|
71767265|NCT04575597|143036283|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
71767266|NCT04575597|143036284|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.36|1.75||||||||1.75|0.36|
71767267|NCT04575597|143036284|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.33|1.64||||||||1.64|0.33|
71767268|NCT04575597|143036284|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.31|1.62||||||||1.62|0.31|
71767269|NCT04575597|143036284|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.76|1.16||||||||1.16|0.76|
71767270|NCT04575597|143036285|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
71767271|NCT04575597|143036285|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.38|1.78||||||||1.78|0.38|
71767272|NCT04575597|143036285|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.25|1.39||||||||1.39|0.25|
71767273|NCT04575597|143036285|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
71767274|NCT04575597|143036286|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.26|1.34||||||||1.34|0.26|
71767275|NCT04575597|143036286|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.28|1.37||||||||1.37|0.28|
71714128|NCT02410772|142943994|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-0.6||||0.05|TWO_SIDED|95.0|-4.3|3.2||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||3.2|-4.3|0.05
71714129|NCT02410772|142943994|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavorable status on the control regimen (2HRZE/ 4 HR) and the investigational regimens, Regimen 2 (2HPZ/2HP) and Regimen 3 (2HPZM/2HPM). If the upper bound of the confidence interval is less than, then the non-inferiority of Arm 2 or Arm 3 to Arm 1 with a significance level of 0.05 is established (equivalent to one-sided α=0.025).|Risk Difference (RD)|-5.1||||0.05|TWO_SIDED|95.0|-8.7|-1.5||For a significance level of 0.05, the statistical test is equivalent to obtaining the two-sided 95% confidence interval for the difference of r\_b-r\_a.|Cochran-Mantel-Haenszel|||For primary Safety endpoint, unfavorable outcomes for Arm1(control) vs Arm3(2PHZM/2PHM) will be considered first, if non-inferiority criteria are met, then Arm 1 vs Arm 2(2PHZE/2PH) will be compared. The proportion of participants with unfavorable outcome can be estimated as: if r\_a and r\_b are the proportions of unfavorable outcome for the two study arms (a=Arm1 and b = Arm2 or Arm3) and if δ is the non-inferiority margin (=6.6%), statistical hypothesis is H\_0:r\_b-r\_a≥δ vs.H\_1:r\_b-r\_a\<δ||-1.5|-8.7|0.05
71714130|NCT02410772|142943999|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-2.45|4.63||||||||4.63|-2.45|
71714131|NCT02410772|142943999|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|4.12|||||TWO_SIDED|95.0|0.45|7.79||||||||7.79|0.45|
71714132|NCT02410772|142944000|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|1.05|||||TWO_SIDED|95.0|-2.01|4.11||||||||4.11|-2.01|
71714133|NCT02410772|142944000|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066)|Risk Difference (RD)|3.66|||||TWO_SIDED|95.0|0.42|6.9||||||||6.90|0.42|
71886832|NCT00403260|143293987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the PCR-corrected ACPR response rate at Day 28 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction). Non-inferiority of PA to MQ + AS was concluded if the lower limit of the CI for the difference was \>-5%.|ACPR percent difference|1.1||||0.106|TWO_SIDED|95.0|-0.2|3.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test is calculated based on a 2-sided Chi-square test. If the calculated p-value is \<5%, then the superiority of PA compared to MQ+AS was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate at Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than 5%.~Was tested versus the alternative:~Alternative hypothesis: the PCR-corrected ACPR response rate at Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate at Day 28 for the comparator group (MQ + AS) by more than -5%."||3.1|-0.2|0.106
71886833|NCT01354028|143293995|SUPERIORITY_OR_OTHER|||||||0.1303||95.0|||||Chi-squared|Degrees of freedom =1||"Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot study"||||0.1303
71886834|NCT01354028|143293998|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Pearson's chi square|Chi-squared|Degrees of freedom=1||"Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98"||||0.026
71714134|NCT02410772|142944002|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.0|||||TWO_SIDED|95.0|-0.6|6.6||||||||6.6|-0.6|
71886835|NCT02109159|143293999|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.44|TWO_SIDED|95.0|0.8|1.4|||Chi-squared||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||1.4|0.8|0.44
71886836|NCT02109159|143293999|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.47|TWO_SIDED|95.0|0.8|1.7|||Chi-squared||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||1.7|0.8|0.47
71886837|NCT02109159|143294000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.|||0.04|-0.02|0.53
71886838|NCT02109159|143294000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.56|TWO_SIDED|95.0|-0.5|0.8|||t-test, 2 sided||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.|||0.8|-0.5|0.56
71714135|NCT02410772|142944002|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|2.29|||||TWO_SIDED|95.0|-1.12|5.7||||||||5.70|-1.12|
71714136|NCT02410772|142944003|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|2.8|8.9||||||||8.9|2.8|
71886839|NCT01664793|143294005|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.||||||<0.05
71886840|NCT03881007|143294007|SUPERIORITY||Incidence rate ratio|1.17||||0.359|TWO_SIDED|95.0|0.84|1.64|||Mixed Models Analysis|||||1.64|0.84|0.359
71886841|NCT03881007|143294008|SUPERIORITY||Incidence rate ratio|5.78||||0.024|TWO_SIDED|95.0|1.52|136.56|||Mixed Models Analysis|||||136.56|1.52|0.024
71714137|NCT02410772|142944003|NON_INFERIORITY|Margin to define inferiority: 6.6% (δ = 0.066).|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|0.5|6.3||||||||6.3|0.5|
71714138|NCT00560417|142944029|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was prespecified at 0.4%|Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|0.06|0.38|||ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group.||||0.38|0.06|
71714139|NCT00560417|142944030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 weeks.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
71714140|NCT00560417|142944030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF)|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.38|0.06|0.008
71714141|NCT00560417|142944031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.003|TWO_SIDED|95.0|0.08|0.39||p-value is for 24 Weeks change.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||0.39|0.08|0.003
71714142|NCT00560417|142944031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.008|TWO_SIDED|95.0|0.06|0.38||p-value is for Endpoint (LOCF) Change.|ANCOVA|||||0.38|0.06|0.008
71714143|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||p-value is for Week 12: HbA1c \<7.0%|Fisher Exact|||||||0.561
71714144|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Week 12: HbA1c \<=6.5%|Fisher Exact|||||||0.511
71714145|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||p-value is for Week 18: HbA1c \<7.0%|Fisher Exact|||||||0.012
71714146|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value is for Week 18: HbA1c \<=6.5%|Fisher Exact|||||||0.269
71886842|NCT03881007|143294009|SUPERIORITY||Incidence rate ratio|1.09||||0.774|TWO_SIDED|95.0|0.61|1.95|||Mixed Models Analysis|||||1.95|0.61|0.774
71886843|NCT03881007|143294010|SUPERIORITY||incidence rate ratio|0.59||||0.323|TWO_SIDED|95.0|0.2|1.63|||Mixed Models Analysis|||||1.63|0.2|0.323
71886844|NCT03881007|143294012|SUPERIORITY||Incidence rate ratio|1.21||||0.279|TWO_SIDED|95.0|0.86|1.72|||Mixed Models Analysis|||||1.72|0.86|0.279
71714147|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||p-value is for Week 24: HbA1c \<7.0%|Fisher Exact|||||||0.161
71714148|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||p-value is for Week 24: HbA1c \<=6.5%|Fisher Exact|||||||0.071
71714149|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||p-value is for Endpoint (LOCF): HbA1c \<7.0%|Fisher Exact|||||||0.177
71714150|NCT00560417|142944032|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Endpoint (LOCF): HbA1c \<=6.5%|Fisher Exact|||||||0.060
71714151|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.28||||0.179|TWO_SIDED|95.0|-1.97|10.53||p-value is for Endpoint Morning Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||10.53|-1.97|0.179
71714152|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|||<|0.001|TWO_SIDED|95.0|5.72|22.19||p-value is for Endpoint Morning Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.19|5.72|<0.001
71714153|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.325|TWO_SIDED|95.0|-3.79|11.39||p-value is for Endpoint Midday Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||11.39|-3.79|0.325
71714154|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.73||||0.051|TWO_SIDED|95.0|-0.04|17.5||p-value is for Endpoint Midday Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||17.50|-0.04|0.051
71714155|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.92||||0.003|TWO_SIDED|95.0|3.66|18.19||p-value is for Endpoint Evening Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.19|3.66|0.003
71714156|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.19||||0.002|TWO_SIDED|95.0|5.44|22.94||p-value is for Endpoint Evening Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||22.94|5.44|0.002
71714157|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.03||||0.415|TWO_SIDED|95.0|-10.35|4.28||p-value is for Endpoint 0300 Hours.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||4.28|-10.35|0.415
71714158|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39||||0.015|TWO_SIDED|95.0|1.46|13.32||p-value is for Endpoint Daily Mean 7-Point Blood Glucose.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.32|1.46|0.015
71714159|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.12||||0.021|TWO_SIDED|95.0|1.1|13.14||p-value is for Endpoint Daily Mean Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||13.14|1.10|0.021
71714160|NCT00560417|142944033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.97|||<|0.001|TWO_SIDED|95.0|5.01|18.93||p-value is for Endpoint Daily Mean Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group||||18.93|5.01|<0.001
71714161|NCT00560417|142944034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.131|TWO_SIDED|95.0|-0.68|5.22||p-value is for Baseline.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||5.22|-0.68|0.131
71714162|NCT00560417|142944034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.001|TWO_SIDED|95.0|2.82|9.16||p-value is for Endpoint.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group||||9.16|2.82|<0.001
71714163|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||p-value is for all reported hypoglycemic events at endpoint.|Fisher Exact|||||||0.826
71714164|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||p-value is for all reported hypoglycemic events overall.|Fisher Exact|||||||0.394
71886845|NCT02634580|143294021|SUPERIORITY||LS Mean Treatment Difference|-39.35|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-47.23|-31.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.48|-47.23|<0.0001
71886846|NCT02634580|143294022|SUPERIORITY||LS Mean Treatment Difference|-40.14|STANDARD_ERROR_OF_MEAN|4.26|<|0.0001|TWO_SIDED|95.0|-48.68|-31.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-31.60|-48.68|< 0.0001
71767276|NCT04575597|143036286|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.38|1.74||||||||1.74|0.38|
71767277|NCT04575597|143036286|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.79|1.21||||||||1.21|0.79|
71767278|NCT04575597|143036287|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.47|3.02||||||||3.02|0.47|
71714165|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||p-value is for non-nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.070
71714166|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for non-nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.133
71714167|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for nocturnal hypoglycemic events at endpoint.|Fisher Exact|||||||0.013
71714168|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||p-value is for nocturnal hypoglycemic events overall.|Fisher Exact|||||||0.061
71714169|NCT00560417|142944035|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||p-value is for severe hypoglycemic events overall.|Fisher Exact|||||||0.248
71714170|NCT00560417|142944036|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||p-value is for All reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.628
71767279|NCT04575597|143036287|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.29|2.2||||||||2.20|0.29|
71714171|NCT00560417|142944036|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||p-value is for All reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.570
71886847|NCT02634580|143294023|SUPERIORITY||LS Mean Treatment Difference|-77.6|STANDARD_ERROR_OF_MEAN|8.1|<|0.0001|TWO_SIDED|95.0|-93.9|-61.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-61.3|-93.9|<0.0001
71714172|NCT00560417|142944036|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||p-value is for Non-Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.116
71714173|NCT00560417|142944036|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for Non-Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.044
71767280|NCT04575597|143036287|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.45||||||||2.45|0.32|
71767281|NCT04575597|143036287|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||||1.11|0.62|
71767282|NCT04575597|143036288|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.3|2.27||||||||2.27|0.30|
71767283|NCT04575597|143036288|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.21|||||TWO_SIDED|95.0|0.04|1.0||||||||1.00|0.04|
71767284|NCT04575597|143036288|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.23|1.91||||||||1.91|0.23|
71767285|NCT04575597|143036288|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.62|1.23||||||||1.23|0.62|
71714174|NCT00560417|142944036|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.006
71714175|NCT00560417|142944036|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable||||||0.004
71714176|NCT00560417|142944037|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||p-value is for endpoint.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)||||||0.343
71714177|NCT00560417|142944038|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||p-value is for the change in body weight at endpoint in the ILPS treatment group.|t-test, 2 sided|||||||0.417
71714178|NCT00560417|142944038|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||p-value is for the change in body weight at endpoint in the glargine treatment group.|t-test, 2 sided|||||||0.041
71714179|NCT00560417|142944038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.343|TWO_SIDED|95.0|-1.15|0.4||p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.|ANOVA|||||0.40|-1.15|0.343
71714180|NCT00560417|142944039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group||||||<0.001
71714181|NCT02164864|142944045|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.42|0.63||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.||0.63|0.42|<0.0001
71714182|NCT02164864|142944045|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.88||P-values for non-inferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority||0.88|0.58|<.0001
71714183|NCT02164864|142944045|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.42|0.63||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.||0.63|0.42|<0.001
71714184|NCT02164864|142944045|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.88||unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Regression, Cox|Wald 2-sided p-value from (unstratified) Cox proportional hazards model||A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|0.88|0.58|0.0020
71714185|NCT02164864|142944046|OTHER||Hazard Ratio (HR)|0.99||||0.9862|TWO_SIDED|95.0|0.25|3.95||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||3.95|0.25|0.9862
71714186|NCT02164864|142944046|OTHER|Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Hazard Ratio (HR)|1.59||||0.5277|TWO_SIDED|95.0|0.38|6.64|||Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||6.64|0.38|0.5277
71714187|NCT02164864|142944047|OTHER||Hazard Ratio (HR)|1.06||||0.8853|TWO_SIDED|95.0|0.5|2.25||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.25|0.50|0.8853
71886848|NCT02634580|143294024|SUPERIORITY||LS Mean Treatment Difference|-79.4|STANDARD_ERROR_OF_MEAN|8.7|<|0.0001|TWO_SIDED|95.0|-96.7|-62.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-62.0|-96.7|<0.0001
71714188|NCT02164864|142944047|OTHER||Hazard Ratio (HR)|0.49||||0.238|TWO_SIDED|95.0|0.15|1.61||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.61|0.15|0.2380
71714189|NCT02164864|142944048|OTHER||Hazard Ratio (HR)|1.17||||0.5252|TWO_SIDED|95.0|0.72|1.88||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.88|0.72|0.5252
71714190|NCT02164864|142944048|OTHER||Hazard Ratio (HR)|0.84||||0.567|TWO_SIDED|95.0|0.47|1.51||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.47|0.5670
71714191|NCT02164864|142944049|OTHER||Hazard Ratio (HR)|1.12||||0.5579|TWO_SIDED|95.0|0.76|1.65||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.65|0.76|0.5579
71714192|NCT02164864|142944049|OTHER||Hazard Ratio (HR)|0.83||||0.4414|TWO_SIDED|95.0|0.51|1.34||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.34|0.51|0.4414
71714193|NCT02164864|142944050|OTHER|Wald 2-sided p-value from (stratified) Cox proportional hazards model|Hazard Ratio (HR)|1.51||||0.0861|TWO_SIDED|95.0|0.94|2.41|||Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.41|0.94|0.0861
71886849|NCT02634580|143294025|SUPERIORITY||Treatment Difference|56.41|||<|0.0001|TWO_SIDED|95.0|34.1|70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||70.70|34.10|<0.0001
71828056|NCT02957539|143160511|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|97.5|-0.7|5.0|||||The change in PHQ-8 from baseline to week 32 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 32 in the no rewards arm|||5.0|-0.7|
71828057|NCT02957539|143160512|SUPERIORITY||Mean Difference (Net)|-1.1|||||TWO_SIDED|97.5|-4.9|2.8|||||Change in PHQ-8 score from baseline to week 52 in the financial rewards arm minus the change in PHQ-8 score from baseline to week 52 in the no rewards arm.|||2.8|-4.9|
71828058|NCT02957539|143160512|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|97.5|-2.9|3.6|||||The change in PHQ-8 from baseline to week 52 in the nonfinancial incentive arm minus the change in PHQ-8 from baseline to week 52 in the no rewards arm|||3.6|-2.9|
71828059|NCT02957539|143160513|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|97.5|-7.4|1.0|||||Change in weight from baseline to week 16 in the financial rewards arm minus the change in weight from baseline to week 16 in the no rewards arm.|||1|-7.4|
71886850|NCT02634580|143294026|SUPERIORITY||Treatment Difference|52.63|||<|0.0001|TWO_SIDED|95.0|30.36|67.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe|||67.52|30.36|< 0.0001
71714194|NCT02164864|142944050|OTHER||Hazard Ratio (HR)|1.16||||0.6144|TWO_SIDED|95.0|0.66|2.04||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.04|0.66|0.6144
71714195|NCT02164864|142944051|OTHER||Hazard Ratio (HR)|1.3||||0.4803|TWO_SIDED|95.0|0.63|2.67||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.67|0.63|0.4803
71714196|NCT02164864|142944051|OTHER||Hazard Ratio (HR)|1.09||||0.8537|TWO_SIDED|95.0|0.42|2.83||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.83|0.42|0.8537
71714197|NCT02164864|142944052|OTHER||Hazard Ratio (HR)|0.94||||0.9388|TWO_SIDED|95.0|0.19|4.66||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.66|0.19|0.9388
71714198|NCT02164864|142944052|OTHER||Hazard Ratio (HR)|0.3||||0.303|TWO_SIDED|95.0|0.03|2.93||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.93|0.03|0.3030
71714199|NCT02164864|142944053|OTHER||Hazard Ratio (HR)|1.86||||0.1546|TWO_SIDED|95.0|0.79|4.4||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||4.40|0.79|0.1546
71714200|NCT02164864|142944053|OTHER||Hazard Ratio (HR)|0.99||||0.9789|TWO_SIDED|95.0|0.35|2.81||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||2.81|0.35|0.9789
71714201|NCT02164864|142944054|OTHER||Hazard Ratio (HR)|1.34||||0.0484|TWO_SIDED|95.0|1.0|1.79||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.79|1.00|0.0484
71828060|NCT02957539|143160513|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|97.5|-8.7|-0.4|||||Change in weight from baseline to week 16 in the nonfinancial rewards arm minus the change in weight from baseline to week 32 in the no rewards arm.|||-0.4|-8.7|
71828061|NCT02957539|143160514|SUPERIORITY||Mean Difference (Net)|2.4|||||TWO_SIDED|97.5|-6.0|10.7|||||Change in weight from baseline to week 52 in the financial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||10.7|-6|
71828062|NCT02957539|143160514|SUPERIORITY||Mean Difference (Net)|-3.6|||||TWO_SIDED|97.5|-11.2|4.1|||||Change in weight from baseline to week 52 in the nonfinancial rewards arm minus the change in weight from baseline to week 52 in the no rewards arm.|||4.1|-11.2|
71828063|NCT03951649|143160581|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
71828064|NCT03951649|143160582|SUPERIORITY||||||>|0.99||||||The p-value was calculated using a 2 sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||>0.99
71828065|NCT03951649|143160583|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
71828066|NCT03951649|143160584|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71828067|NCT03951649|143160585|SUPERIORITY|||||||1||||||P-value was calculated|Fisher Exact|||||||1.00
71828068|NCT03951649|143160586|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71828069|NCT03951649|143160587|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
71828070|NCT03951649|143160589|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
71828071|NCT03951649|143160590|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
71828072|NCT03951649|143160591|SUPERIORITY|||||||0.92|||||||Fisher Exact|||||||0.92
71828073|NCT03951649|143160592|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71828074|NCT03951649|143160593|SUPERIORITY|||||||0.14|||||||Fisher Exact|||||||0.14
71886851|NCT02634580|143294027|SUPERIORITY||LS Mean Treatment Difference|-25.44|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-30.8|-20.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.08|-30.80|<0.0001
71828075|NCT03951649|143160594|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
71656681|NCT00311311|142831327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33||||0.4066|TWO_SIDED|95.0|-4.53|1.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||1.86|-4.53|0.4066
71656682|NCT00311311|142831328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.47||||0.3678|TWO_SIDED|95.0|-11.46|30.4||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||30.40|-11.46|0.3678
71656683|NCT00311311|142831328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.72||||0.2179|TWO_SIDED|95.0|-6.53|27.97||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||27.97|-6.53|0.2179
71656684|NCT00311311|142831328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.96||||0.3663|TWO_SIDED|95.0|-14.39|38.32||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||38.32|-14.39|0.3663
71656685|NCT00311311|142831329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.041|TWO_SIDED|95.0|0.0|0.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||0.8|0.0|0.0410
71656686|NCT00311311|142831329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0275|TWO_SIDED|95.0|0.0|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||0.6|0.0|0.0275
71656687|NCT00311311|142831329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1841|TWO_SIDED|95.0|-0.1|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||0.6|-0.1|0.1841
71656688|NCT00311311|142831330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.3||||0.0797|TWO_SIDED|95.0|-108.9|6.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||12 months post-transplant||6.3|-108.9|0.0797
71656689|NCT00311311|142831330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.3||||0.2341|TWO_SIDED|95.0|-88.7|22.2||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant||22.2|-88.7|0.2341
71656690|NCT00311311|142831330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2||||0.6854|TWO_SIDED|95.0|-90.3|59.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||59.8|-90.3|0.6854
71656691|NCT00311311|142831331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.8||||0.0002|TWO_SIDED|95.0|-108.6|-36.9||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant||-36.9|-108.6|0.0002
71656692|NCT00311311|142831331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.6||||0.0017|TWO_SIDED|95.0|-108.5|-26.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant||-26.6|-108.5|0.0017
71656693|NCT00311311|142831331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.3||||0.0293|TWO_SIDED|95.0|-118.2|-6.5||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant||-6.5|-118.2|0.0293
71656694|NCT00311311|142831333|SUPERIORITY_OR_OTHER|||||||0.2573|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Consent to Conversion||||0.2573
71656695|NCT00311311|142831333|SUPERIORITY_OR_OTHER|||||||0.6386|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Conversion to Month 12||||0.6386
71656696|NCT00311311|142831333|SUPERIORITY_OR_OTHER|||||||0.0709|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 12 to Month 24||||0.0709
71656697|NCT00311311|142831333|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 24 to Month 36||||1.0000
71656698|NCT00311311|142831334|SUPERIORITY_OR_OTHER|||||||0.4286|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Consent to Conversion||||0.4286
71656699|NCT00311311|142831334|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Conversion to Month 12||||1.0000
71714202|NCT02164864|142944054|OTHER||Hazard Ratio (HR)|1.03||||0.8903|TWO_SIDED|95.0|0.71|1.47||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.47|0.71|0.8903
71714203|NCT02164864|142944055|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.17||||0.1128|TWO_SIDED|95.0|0.9|1.53||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.||1.53|0.90|0.1128
71714204|NCT02164864|142944055|OTHER||Hazard Ratio (HR)|1.3||||0.072|TWO_SIDED|95.0|0.98|1.73||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.73|0.98|0.0720
71714205|NCT02164864|142944055|OTHER||Hazard Ratio (HR)|0.97||||0.875|TWO_SIDED|95.0|0.68|1.39||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.39|0.68|0.8750
71714206|NCT02164864|142944056|OTHER||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.79|1.51||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.51|0.79|0.6080
71714207|NCT02164864|142944056|OTHER||Hazard Ratio (HR)|0.96||||0.8348|TWO_SIDED|95.0|0.65|1.41||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.41|0.65|0.8348
71714208|NCT02164864|142944057|NON_INFERIORITY|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.04||||0.0047|TWO_SIDED|95.0|0.84|1.29||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.||1.29|0.84|0.0047
71714209|NCT02164864|142944057|OTHER||Hazard Ratio (HR)|1.13||||0.3002|TWO_SIDED|95.0|0.9|1.43||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non-elderly vs elderly \[\<70 or \>=70 in Japan and \<80 or \>=80 years old elsewhere\].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.43|0.90|0.3002
71714210|NCT02164864|142944057|OTHER||Hazard Ratio (HR)|0.89||||0.4432|TWO_SIDED|95.0|0.67|1.19||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|||1.19|0.67|0.4432
71714211|NCT04358406|142944060|SUPERIORITY||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
71714212|NCT04358406|142944060|SUPERIORITY||||||>|0.1|||||||Chi-squared|||||||>0.1
71714213|NCT01668004|142944082|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.||||1.0000
71714214|NCT01668004|142944083|SUPERIORITY_OR_OTHER||Treatment Ratio|4.5|||<|0.0001|TWO_SIDED|95.0|3.86|5.25|||Generalized estimating equation|||Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.||5.25|3.86|<0.0001
71714215|NCT02448381|142944091|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||||||0.04
71714216|NCT02448381|142944092|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
71714217|NCT02448381|142944093|SUPERIORITY|||||||0.046|||||||McNemar|||||||0.046
71714218|NCT02448381|142944094|SUPERIORITY||||||=|0.0009|||||||Fisher Exact|||||||=0.0009
71714219|NCT02448381|142944095|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71714220|NCT02735200|142944098|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.9|TWO_SIDED|||||the p value correspond to the pretreatment time frame.|t-test, 2 sided|||||||0.9
71714221|NCT02735200|142944098|SUPERIORITY||Mean Difference (Final Values)|26.66|||<|0.001|TWO_SIDED|||||p value corresponds to the post treatment time frame.|t-test, 2 sided|||||||<0.001
71714222|NCT01164007|142944117|SUPERIORITY_OR_OTHER|||||||0.071|||||||One-sample exact binomial test|||The observed percentage of participants with CR or PR was compared with the expected proportion under the null hypothesis (0.10) and analyzed for statistical significance using a one-sample exact binomial test.||||0.071
71714223|NCT01816295|142944133|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71714224|NCT01816295|142944134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|99.5|1.05|9.07|||ANCOVA|||||9.07|1.05|<0.001
71714225|NCT01816295|142944135|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|1.25||0.019|TWO_SIDED|99.5|-0.59|6.45|||ANCOVA|||||6.45|-0.59|0.019
71714226|NCT01816295|142944136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.442|TWO_SIDED|95.0|-0.94|0.41|||ANCOVA|||Change from Baseline to Week 12||0.41|-0.94|0.442
71714227|NCT01816295|142944136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.905|TWO_SIDED|95.0|-0.82|0.72|||ANCOVA|||Change from Baseline to Week 36||0.72|-0.82|0.905
71656700|NCT00311311|142831334|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 12 to Month 24||||1.0000
71656701|NCT00311311|142831334|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 24 to Month 36||||1.0000
71656702|NCT00311311|142831335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0||||0.2718|TWO_SIDED|95.0|-50.7|14.7||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant||14.7|-50.7|0.2718
71656703|NCT00311311|142831335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.2729|TWO_SIDED|95.0|-41.6|12.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant||12.1|-41.6|0.2729
71656704|NCT00311311|142831335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.2902|TWO_SIDED|95.0|-23.8|7.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant||7.3|-23.8|0.2902
71656705|NCT00988065|142831339|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
71656706|NCT00988065|142831339|SUPERIORITY_OR_OTHER||Difference in event rates|4.7||||||95.0|2.1|9.3|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||9.3|2.1|
71656707|NCT00988065|142831340|SUPERIORITY_OR_OTHER||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||3.7|-1.8|
71656708|NCT00988065|142831340|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|||2.5|-2.5|
71656709|NCT00988065|142831341|SUPERIORITY_OR_OTHER||Difference in event rates|2.0||||||95.0|-0.5|5.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||5.7|-0.5|
71656710|NCT00988065|142831341|SUPERIORITY_OR_OTHER||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.||2.5|-2.5|
71656711|NCT01229735|142831347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||=|0.7007|TWO_SIDED|95.0|0.7|1.7||P-value is from likelihood ratio test of treatment group regression coefficient against 0.|Regression, Logistic|||The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.||1.7|0.7|=0.7007
71656712|NCT00985712|142831363|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6692|TWO_SIDED|95.0|-0.17|0.26|||Mixed Models Analysis|The model details are given in the section of Measure Description.||Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.||0.26|-0.17|0.6692
71656713|NCT00985712|142831364|SUPERIORITY_OR_OTHER|||||||0.3551||95.0||||P-value is for HbA1c ≤7.0%.|Chi-squared|||||||0.3551
71656714|NCT00985712|142831364|SUPERIORITY_OR_OTHER|||||||0.2026||95.0||||P-value is for HbA1c ≤7.5%.|Chi-squared|||||||0.2026
71656715|NCT00985712|142831365|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) was adjusted for baseline values.||||||0.9070
71656716|NCT00985712|142831366|SUPERIORITY_OR_OTHER|||||||0.9817||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9817
71656717|NCT00985712|142831367|SUPERIORITY_OR_OTHER|||||||0.1187||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1187
71656718|NCT00876018|142831373|OTHER|||||||0.004||95.0|||||Mann Whitney U test|||||||0.004
71656719|NCT00876018|142831373|OTHER|||||||0.147||95.0|||||Mann Whitney U test|||||||0.147
71656720|NCT00876018|142831374|OTHER|||||||0.002||95.0|||||Mann Whitney U test|||||||0.002
71656721|NCT00876018|142831374|OTHER|||||||0.003||95.0|||||Mann Whitney U test|||||||0.003
71656722|NCT00876018|142831375|OTHER|||||||0.153||95.0|||||Mann Whitney U test|||||||0.153
71656723|NCT00876018|142831375|OTHER|||||||0.903||95.0|||||Mann Whitney U test|||||||0.903
71656724|NCT00876018|142831376|OTHER|||||||0.143||95.0|||||Mann Whitney U test|||||||0.143
71656725|NCT00876018|142831376|OTHER|||||||0.678||95.0|||||Mann Whitney U test|||||||0.678
71656726|NCT01189500|142831399|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.69|||||TWO_SIDED|90.0|96.7|104.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||104.85|96.70|
71656727|NCT01189500|142831401|SUPERIORITY_OR_OTHER||ratio of adjusted means|99.44|||||TWO_SIDED|90.0|94.02|105.17|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||105.17|94.02|
71656728|NCT01189500|142831406|SUPERIORITY_OR_OTHER||ratio of adjusted means|92.04|||||TWO_SIDED|90.0|84.71|100.0|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||100.00|84.71|
71656729|NCT01189500|142831412|SUPERIORITY_OR_OTHER||ratio of adjusted means|112.07|||||TWO_SIDED|90.0|107.44|116.9|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||116.90|107.44|
71656730|NCT01189500|142831417|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.6|||||TWO_SIDED|90.0|99.74|111.81|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||111.81|99.74|
71656731|NCT01189500|142831418|SUPERIORITY_OR_OTHER||ratio of adjusted means|108.47|||||TWO_SIDED|90.0|103.51|113.67|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)||113.67|103.51|
71714228|NCT01259011|142944168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.05|TWO_SIDED|95.0|1.1|3.3|||Mixed Models Analysis|||||3.3|1.1|<.05
71714229|NCT01259011|142944169|SUPERIORITY||Slope|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||HADS-anxiety|Regression, Linear|||||0.3|-2.8|0.12
71714230|NCT01259011|142944169|SUPERIORITY||Slope|-2.2|||<|0.05|TWO_SIDED|95.0|-4.2|-0.3||HADS-depression|Regression, Linear|||||-0.3|-4.2|<0.05
71714231|NCT01259011|142944170|SUPERIORITY||Slope|-4.0||||0.21|TWO_SIDED|95.0|-10.2|2.2|||Regression, Linear|||||2.2|-10.2|0.21
71714232|NCT03510273|142944188|OTHER|"Type of statistical test: Independence~Description: Adequacy of baseline image"||||||0.396|||||||Fisher Exact|||||||0.396
71714233|NCT03510273|142944188|OTHER|"Type of statistical test: Independence~Description: Squamous columnar junction visibility"||||||0.351|||||||Fisher Exact|||||||0.351
71714234|NCT03510273|142944188|OTHER|"Type of statistical test: Independence~Description: Visible abnormal areas"||||||0.774|||||||Fisher Exact|||||||0.774
71714235|NCT03510273|142944188|OTHER|"Type of statistical test: Independence~Description: Location of the lesion"||||||1|||||||Fisher Exact|||||||1
71714236|NCT03510273|142944188|OTHER|"Type of statistical test: Independence~Description: Mosaic of the worst lesion"||||||0.36|||||||Fisher Exact|||||||0.36
71714237|NCT03510273|142944188|OTHER|"Type of Statistical Test: Independence~Description: Acetowhite changes"||||||0.881|||||||Fisher Exact|||||||0.881
71714238|NCT03510273|142944188|OTHER|"Type of Statistical Test: Independence~Description: Border of the worst lesion"||||||0.829|||||||Fisher Exact|||||||0.829
71714239|NCT03510273|142944188|OTHER|"Type of Statistical Test: Independence~Description: Possible diagnosis"||||||1|||||||Fisher Exact|||||||1
71714240|NCT03510273|142944188|OTHER|"Type of Statistical Test: Independence~Description: Baseline histology"||||||1|||||||Fisher Exact|||||||1
71767286|NCT04575597|143036289|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.28|1.2||||||||1.20|0.28|
71714241|NCT03510273|142944188|OTHER|"Type of Statistical Test: Independence~Description: Size of the worst lesion (% coverage)"||||||0.493|||||||Fisher Exact|||||||0.493
71714242|NCT01276106|142944189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.175||0.044|TWO_SIDED|95.0|-0.7|-0.01||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||-0.01|-0.70|0.044
71714243|NCT01276106|142944189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.176||0.0979|TWO_SIDED|95.0|-0.64|0.05||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.05|-0.64|0.0979
71714244|NCT01276106|142944189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.174||0.2643|TWO_SIDED|95.0|-0.54|0.15||No adjustments for multiple comparisons were made and a value of p\<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.||0.15|-0.54|0.2643
71714245|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.||||<0.001
71714246|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||mann whitney u to compare rosenberg score baseline to 1 hour||||<.001
71714247|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.001
71714248|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.001
71714249|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.001
71714250|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours||||<0.01
71714251|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours||||<0.01
71714252|NCT00867035|142944201|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||baseline to 1 week||||<0.05
71714253|NCT00867035|142944202|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 hour analyzed between groups.||||>0.05
71714254|NCT00867035|142944203|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
71714255|NCT00867035|142944204|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 4 hours analyzed between groups||||>0.05
71714256|NCT00867035|142944205|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
71714257|NCT00867035|142944206|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 1 hour analyzed between groups||||>0.05
71714258|NCT00867035|142944207|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
71714259|NCT00867035|142944208|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.||||>0.05
71714260|NCT00867035|142944209|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test||||>0.05
71714261|NCT00867035|142944210|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groups||||>0.05
71714262|NCT00867035|142944211|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.||||>0.05
71828076|NCT02371746|143160595|SUPERIORITY||Change from baseline|30.4|STANDARD_DEVIATION|1.84|<|0.001|TWO_SIDED|95.0|-1.8|36.6|||ANCOVA|||estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost||36.6|-1.8|<0.001
71828077|NCT01157182|143160596|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.94|||||TWO_SIDED|90.0|97.63|108.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.55|97.63|
71828078|NCT01157182|143160597|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.4|||||TWO_SIDED|90.0|95.15|101.76|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.76|95.15|
71828079|NCT01157182|143160598|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.73|||||TWO_SIDED|90.0|95.33|102.26|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.26|95.33|
71828080|NCT01157182|143160599|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.51|||||TWO_SIDED|90.0|88.64|96.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||96.55|88.64|
71828081|NCT01157182|143160600|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.66|||||TWO_SIDED|90.0|92.6|98.81|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.81|92.60|
71886852|NCT02634580|143294028|SUPERIORITY||LS Mean Treatment Difference|-25.83|STANDARD_ERROR_OF_MEAN|2.89|<|0.0001|TWO_SIDED|95.0|-31.63|-20.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.04|-31.63|<0.0001
71714263|NCT00404248|142944214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.9|ONE_SIDED||||||t-test, 2 sided|||||||0.9
71714264|NCT00404248|142944215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.6
71714265|NCT00404248|142944216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.8|TWO_SIDED||||||t-test, 2 sided|||||||0.8
71886853|NCT02634580|143294029|SUPERIORITY||LS Mean Treatment Difference|-33.53|STANDARD_ERROR_OF_MEAN|3.42|<|0.0001|TWO_SIDED|95.0|-40.38|-26.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-26.68|-40.38|< 0.0001
71886854|NCT02634580|143294030|SUPERIORITY||LS Mean Treatment Difference|-33.44|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-40.94|-25.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-25.94|-40.94|<0.0001
71714266|NCT04066829|142944264|OTHER||Difference in Differences|-29.2|||||TWO_SIDED|95.0|-42.2|-11.8||||||Pre and post difference in the treatment group as compared to the control group. A log transformation was used.||-11.8|-42.2|
71714267|NCT00285779|142944329|SUPERIORITY_OR_OTHER|||||||0.0978|TWO_SIDED||||||Fisher Exact|||||||0.0978
71714268|NCT00285779|142944330|OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71714269|NCT00285779|142944331|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
71714270|NCT00285779|142944331|OTHER|||||||0.34|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.34
71714271|NCT00285779|142944331|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
71714272|NCT00285779|142944331|OTHER|||||||0.22|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.22
71714273|NCT00285779|142944332|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
71714274|NCT00285779|142944332|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
71714275|NCT00285779|142944333|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
71714276|NCT00285779|142944333|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline||||>0.9999
71886855|NCT02634580|143294031|SUPERIORITY||LS Mean Treatment Difference|-35.67|STANDARD_ERROR_OF_MEAN|3.31|<|0.0001|TWO_SIDED|95.0|-42.3|-29.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.04|-42.30|< 0.0001
71714277|NCT00285779|142944333|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.063
71714278|NCT00285779|142944333|OTHER||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline||||>0.9999
71714279|NCT00285779|142944334|OTHER|||||||0.063|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.063
71714280|NCT00285779|142944334|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
71714281|NCT00285779|142944334|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.031
71714282|NCT00285779|142944334|OTHER|||||||0.32|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.32
71714283|NCT00285779|142944335|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
71714284|NCT00285779|142944335|OTHER|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.25
71714285|NCT00285779|142944335|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
71714286|NCT00285779|142944335|OTHER|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.13
71714287|NCT00285779|142944336|OTHER|||||||0.63|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.63
71767287|NCT04575597|143036289|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.2|0.95||||||||0.95|0.20|
71886856|NCT02634580|143294032|SUPERIORITY||LS Mean Treatment Difference|-36.6|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-43.98|-29.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.22|-43.98|<0.0001
71714288|NCT00285779|142944336|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.38
71714289|NCT00285779|142944336|OTHER|||||||0.38|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.38
71714290|NCT00285779|142944336|OTHER|||||||0.5|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.50
71714291|NCT00285779|142944337|OTHER|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.031
71714292|NCT00285779|142944337|OTHER|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline||||0.094
71714293|NCT00285779|142944337|OTHER|||||||0.039|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.039
71714294|NCT00285779|142944337|OTHER|||||||0.19|||||||Wilcoxon Paired|||Week 24 versus baseline||||0.19
71714295|NCT00285779|142944338|OTHER|||||||0.26|||||||Paired t test|||Week 12 versus baseline||||0.26
71714296|NCT00285779|142944338|OTHER|||||||0.55|||||||Paired t test|||Week 12 versus baseline||||0.55
71714297|NCT00285779|142944338|OTHER|||||||0.18|||||||Paired t test|||Week 24 versus baseline||||0.18
71714298|NCT00285779|142944338|OTHER|||||||0.13|||||||Paired t test|||Week 24 versus baseline||||0.13
71714299|NCT00285779|142944339|OTHER|||||||0.51|||||||Paired t test|||Week 12 versus baseline||||0.51
71714300|NCT00285779|142944339|OTHER|||||||0.47|||||||Paired t test|||Week 24 versus baseline||||0.47
71714301|NCT00285779|142944339|OTHER|||||||0.087|||||||Paired t test|||Week 24 versus baseline||||0.087
71714302|NCT00285779|142944339|OTHER|||||||0.86|||||||Paired t test|||Week 24 versus baseline||||0.86
71714303|NCT00285779|142944340|OTHER|||||||0.033|||||||Paired t test|||Week 12 versus baseline||||0.033
71714304|NCT00285779|142944340|OTHER|||||||0.069|||||||Paired t test|||Week 12 versus baseline||||0.069
71714305|NCT00285779|142944340|OTHER|||||||0.015|||||||Paired t test|||Week 24 versus baseline||||0.015
71714306|NCT00285779|142944340|OTHER|||||||0.026|||||||Paired t test|||Week 24 versus baseline||||0.026
71714307|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.4|0.9||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.9|-3.4|<0.001
71714308|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|2.2|||<|0.001|TWO_SIDED|95.0|1.7|2.8||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||2.8|1.7|<0.001
71714309|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.4||||0.61|TWO_SIDED|95.0|-1.0|1.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.7|-1.0|0.61
71714310|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.4|TWO_SIDED|95.0|-0.1|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|-0.1|0.40
71714311|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0||||0.12|TWO_SIDED|95.0|0.0|0.1||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.1|0.0|0.12
71714312|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.1|0.0||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||0.0|-0.1|<0.001
71714313|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|1.0|1.5||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.5|1.0|<0.001
71714314|NCT01576783|142944361|OTHER|The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|TWO_SIDED|95.0|0.9|1.4||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||1.4|0.9|<0.001
71714315|NCT01576783|142944362|OTHER|The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.5|-3.7||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.||-3.7|-5.5|<0.001
71714316|NCT01576783|142944365|OTHER|The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).||||||0.13||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.13
71714317|NCT01576783|142944365|OTHER|The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).||||||0.76||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||||||.76
71714318|NCT01576783|142944366|OTHER|The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).||||||0.66||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.66
71714319|NCT01576783|142944366|OTHER|The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).||||||0.55||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.55
71714320|NCT01576783|142944366|OTHER|The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).||||||0.88||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve \>80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.||||.88
71714321|NCT01576783|142944367|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||.11
71714322|NCT01576783|142944367|OTHER|The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).||||||0.47||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.47
71714323|NCT01576783|142944367|OTHER|The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||||||0.32
71714324|NCT01576783|142944368|OTHER|The reported p-value is for the comparison of the change in weight-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.99||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.99
71767288|NCT04575597|143036289|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.43|1.59||||||||1.59|0.43|
71714325|NCT01576783|142944368|OTHER|The reported p-value is for the comparison of the change in length-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.27||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.27
71714326|NCT01576783|142944368|OTHER|The reported p-value is for the comparison of the change in head circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.39||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.39
71714327|NCT01576783|142944368|OTHER|The reported p-value is for the comparison of the change in mid upper arm circumference-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.25||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.25
71714328|NCT01576783|142944368|OTHER|The reported p-value is for the comparison of the change in triceps skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.85||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.85
71714329|NCT01576783|142944368|OTHER|The reported p-value is for the comparison of the change in subscapular skinfold-for-age z scores between groups (DHA+AA vs. Placebo).||||||0.82||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed-effects regression that leveraged maximum likelihood to account for missing data.||||||0.82
71714330|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.42||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.42
71714331|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.68||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.68
71714332|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.78||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.78
71714333|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.32||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.32
71714334|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.97||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.97
71714335|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.62||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.62
71714336|NCT01576783|142944369|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.69||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.69
71714337|NCT01576783|142944370|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at the end of the trial.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.22
71714338|NCT01576783|142944371|OTHER|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.23
71714339|NCT01576783|142944371|OTHER|The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.07||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.07
71714340|NCT01576783|142944371|OTHER|The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||||||0.06
71767289|NCT04575597|143036289|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19||||||||1.19|0.73|
71828082|NCT01157182|143160601|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.71|||||TWO_SIDED|90.0|92.62|98.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.91|92.62|
71886857|NCT02634580|143294033|SUPERIORITY||LS Mean Treatment Difference|-28.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-35.26|-21.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-21.97|-35.26|< 0.0001
71714341|NCT01576783|142944372|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.51||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Continuous scores at the end of the trial were compared using a linear mixed model.||||||0.51
71714342|NCT01576783|142944373|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.09||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.09
71886858|NCT02634580|143294034|SUPERIORITY||LS Mean Treatment Difference|-27.05|STANDARD_ERROR_OF_MEAN|3.47|<|0.0001|TWO_SIDED|95.0|-34.0|-20.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.09|-34.00|< 0.0001
71886859|NCT02634580|143294035|SUPERIORITY||LS Mean Treatment Difference|-37.07|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-43.65|-30.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-30.50|-43.65|<0.0001
71886860|NCT02634580|143294036|SUPERIORITY||LS Mean Treatment Difference|-36.29|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-43.39|-29.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-29.20|-43.39|<0.0001
71714343|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.29
71714344|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.11||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.11
71714345|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.23||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.23
71714346|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.29||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.29
71714347|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.06||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.06
71714348|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.14||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.14
71714349|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.13||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.13
71714350|NCT01576783|142944374|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.16||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.16
71714351|NCT01576783|142944375|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.98|||||||Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.98
71714352|NCT01576783|142944375|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.67||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.67
71714353|NCT01576783|142944376|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.047||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups.||||||0.047
71714354|NCT01576783|142944377|OTHER|The reported p-value is for the comparison of the scores between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).||||||0.2||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|Linear mixed models compared continuous scores at follow-up between treatment groups. Model controlled for baseline scores.||||||0.20
71714355|NCT01576783|142944378|OTHER|Results are the comparison of proportion of those with a developmental condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.8|3.32||||||||3.32|0.80|
71767290|NCT04575597|143036290|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.35|2.11||||||||2.11|0.35|
71714356|NCT01576783|142944379|OTHER|Results are the comparison of proportion of those with a behavioral condition between groups (DHA+AA vs. Placebo) at post-intervention follow-up (median of 8.3 months (IQR = 4.8) after trial completion and supplementation stopped).|Odds Ratio (OR)|4.5|||||TWO_SIDED|95.0|0.52|39.15||||||||39.15|0.52|
71714357|NCT02180828|142944415|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.925|||||||Chi-squared|||||||0.925
71714358|NCT02180828|142944416|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.298|||||||Chi-squared|||||||0.298
71714359|NCT02180828|142944417|NON_INFERIORITY_OR_EQUIVALENCE|90% power and a two-sided alpha level of 0.05||||||0.147|||||||Chi-squared|||||||0.147
71714360|NCT02180828|142944418|NON_INFERIORITY_OR_EQUIVALENCE|Yes||||||0.147|||||||Chi-squared|||||||0.147
71714361|NCT02180828|142944419|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
71714362|NCT02180828|142944420|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71714363|NCT02180828|142944421|SUPERIORITY_OR_OTHER|||||||0.658|||||||Chi-squared|||||||0.658
71714364|NCT02180828|142944422|SUPERIORITY_OR_OTHER|||||||0.123|||||||Chi-squared|||||||0.123
71714365|NCT02180828|142944423|SUPERIORITY_OR_OTHER|||||||0.274|||||||Chi-squared|||||||0.274
71714366|NCT01276704|142944424|SUPERIORITY|||||||0.72||||||a priori threshold for statistical significance: \< 0.05|Wilcoxon (Mann-Whitney)|||83% power to detect an absolute 2.5% reduction in Ki-67 for the treatment group compared with no reduction in the control group.||||0.72
71828083|NCT01157182|143160602|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.41|||||TWO_SIDED|90.0|88.65|96.33|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||96.33|88.65|
71886861|NCT02634580|143294037|SUPERIORITY||LS Mean Treatment Difference|-31.13|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|-41.83|-20.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-20.43|-41.83|<0.0001
71886862|NCT02634580|143294038|SUPERIORITY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|6.17|<|0.0001|TWO_SIDED|95.0|-43.57|-18.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||-18.84|-43.57|<0.0001
71886863|NCT02634580|143294039|SUPERIORITY||LS Mean Treatment Difference|3.49|STANDARD_ERROR_OF_MEAN|7.31||0.63|TWO_SIDED|95.0|-11.15|18.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||18.13|-11.15|0.63
71886864|NCT02634580|143294040|SUPERIORITY||LS Mean Treatment Difference|11.79|STANDARD_ERROR_OF_MEAN|9.52||0.22|TWO_SIDED|95.0|-7.29|30.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||30.87|-7.29|0.22
71767291|NCT04575597|143036290|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.16|1.34||||||||1.34|0.16|
71714367|NCT01276704|142944425|SUPERIORITY|||||||0.018||||||No adjustment for multiple comparisons. Standard threshold of P\<0.05|Wilcoxon (Mann-Whitney)|||||||0.018
71714368|NCT01276704|142944426|SUPERIORITY|||||||0.036||||||No adjustment for multiple comparisons. Standard threshold of P \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.036
71714369|NCT03801525|142944432|SUPERIORITY||Hazard Ratio (HR)|0.778||||0.696|TWO_SIDED|95.0|0.219|2.755|||Log Rank|||||2.755|0.219|0.6960
71714370|NCT03801525|142944439|SUPERIORITY||Hazard Ratio (HR)|0.201||||0.1038|TWO_SIDED|95.0|0.023|1.721|||Log Rank|||||1.721|0.023|0.1038
71714371|NCT01440764|142944584|SUPERIORITY|||||||0.99||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. This p-value describes the a priori analysis of comparing the furosemide test result to the saline test result.|t-test, 2 sided|||||||0.99
71714372|NCT01440764|142944584|SUPERIORITY|||||||0.32||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. Thes p-value describes the a priori analysis of comparing the response to furosemide to the mean response to saline.|t-test, 2 sided|||||||0.32
71714373|NCT01440764|142944586|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0006
71714374|NCT01440764|142944586|SUPERIORITY||||||=|1e-05||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||=.00001
71714375|NCT01440764|142944586|SUPERIORITY|||||||2e-07||||||a priori threshold for significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|||||||.0000002
71714376|NCT00320606|142944587|OTHER||95% confidence interval using an exact b|0.6|||||TWO_SIDED|95.0|0.4|0.8|||||Proportion Success|The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method||0.8|0.4|
71714377|NCT00320606|142944588|OTHER||Binomial Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.1684|||||95% Confidence Interval Exact Binomial|The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.||0.1684|0.0|
71714378|NCT02621892|142944730|SUPERIORITY||Risk Difference (RD)|8.31|||<|0.02|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.02
71714379|NCT02621892|142944732|SUPERIORITY||Risk Difference (RD)|10.86|||<|0.008|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.008
71714380|NCT02621892|142944733|SUPERIORITY||Risk Difference (RD)|10.34|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71886865|NCT02634580|143294041|SUPERIORITY||LS Mean Treatment Difference|7.96|STANDARD_ERROR_OF_MEAN|3.08||0.012|TWO_SIDED|95.0|1.78|14.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||14.14|1.78|0.012
71886866|NCT02634580|143294042|SUPERIORITY||LS Mean Treatment Difference|5.59|STANDARD_ERROR_OF_MEAN|3.2||0.086|TWO_SIDED|95.0|-0.82|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||12.00|-0.82|0.086
71714381|NCT02621892|142944734|SUPERIORITY||Risk Difference (RD)|11.92|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71714382|NCT02621892|142944735|SUPERIORITY||Risk Difference (RD)|10.9|||<|0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.003
71714383|NCT00934921|142944736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.1||||||90.0|91.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.2|
71714384|NCT00934921|142944737|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.2||||||90.0|88.8|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|88.8|
71714385|NCT00934921|142944738|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.9||||||90.0|89.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|89.5|
71714386|NCT03781479|142944739|OTHER||Mean Difference (Net)|0.792||||0.0083|TWO_SIDED|95.0|0.22|1.37|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments along with a 95% confidence interval for this difference.|A mixed effects liner model was fit with the HFMSE change from baseline (CFB) scores at Day 28 as a response and treatment, sequence, and treatment by sequence as fixed effect terms and patient as a random effect.||1.37|0.22|0.0083
71714387|NCT02921256|142944740|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
71714388|NCT02921256|142944740|SUPERIORITY|||||||0.26|||||||Regression, Linear|||||||0.26
71714389|NCT04211363|142944766|SUPERIORITY||Odds Ratio (OR)|20.69|||<|0.0001|TWO_SIDED|95.0|7.58|56.48|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data..|IGA Success Odds Ratio||56.48|7.58|<0.0001
71714390|NCT04211363|142944767|SUPERIORITY||Hazard Ratio (HR)|3.867|||<|0.0001|TWO_SIDED|95.0|2.795|5.351|||Log Rank|Unstratified log-rank test|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to PASI-50||5.351|2.795|<0.0001
71714391|NCT04211363|142944768|SUPERIORITY||Odds Ratio (OR)|12.0|||<|0.0001|TWO_SIDED|95.0|5.15|27.93|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||27.93|5.15|<0.0001
71714392|NCT04211363|142944769|SUPERIORITY||Odds Ratio (OR)|17.9|||<|0.0001|TWO_SIDED|95.0|4.38|73.09|||Cochran-Mantel-Haenszel|Stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|Cochran-Mantel-Haenszel stratified by study site, baseline IGA score, and baseline intertriginous involvement with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||73.09|4.38|<0.0001
71714393|NCT04211363|142944770|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.0001|TWO_SIDED|95.0|2.33|138.2|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||138.20|2.33|<0.0001
71714394|NCT04211363|142944771|SUPERIORITY||Odds Ratio (OR)|29.36||||0.003|TWO_SIDED|95.0|2.99|288.36|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||288.36|2.99|0.003
71714395|NCT04211363|142944772|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1197|TWO_SIDED|95.0|0.98|3.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 2 Odds Ratio||3.19|0.98|0.1197
71714396|NCT04211363|142944772|SUPERIORITY||Odds Ratio (OR)|4.36|||<|0.0001|TWO_SIDED|95.0|2.31|8.26|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS Success at Week 4 Odds Ratio||8.26|2.31|<0.0001
71714397|NCT04211363|142944772|SUPERIORITY||Odds Ratio (OR)|7.84|||<|0.0001|TWO_SIDED|95.0|3.85|15.94|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common odds ratio stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|WI-NRS at Week 8 Odds Ratio||15.94|3.85|<0.0001
71767292|NCT04575597|143036290|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.5|2.79||||||||2.79|0.50|
71767293|NCT04575597|143036290|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.74|1.32||||||||1.32|0.74|
71767294|NCT04575597|143036291|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.06|15.54||||||||15.54|0.06|
71767295|NCT04575597|143036291|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0||NA = Upper limit not reached as no events were recorded||||||||0.00|
71767296|NCT04575597|143036291|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.06|15.99||||||||15.99|0.06|
71767297|NCT04575597|143036291|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.46|1.25||||||||1.25|0.46|
71767298|NCT04575597|143036292|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.58|3.83||||||||3.83|0.58|
71767299|NCT04575597|143036292|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.42|3.05||||||||3.05|0.42|
71767300|NCT04575597|143036292|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|0.57|3.93||||||||3.93|0.57|
71767301|NCT04575597|143036292|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||||1.10|0.61|
71767302|NCT04575597|143036293|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.11|1.21||||||||1.21|0.11|
71886867|NCT02634580|143294043|SUPERIORITY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|7.26||0.93|TWO_SIDED|95.0|-15.22|13.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||13.87|-15.22|0.93
71656732|NCT03736213|142831445|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.13|TWO_SIDED||||||paired t-test, two-tailed|df = 6|Ultrasound biofeedback treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower normalized acoustic values, a negative difference indicates an advantage for US biofeedback.|||||.13
71656733|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.11|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.09|-0.11|
71656734|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.38|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.38|
71656735|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||TWO_SIDED|95.0|-0.37|-0.16|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.16|-0.37|
71656736|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.3|||||TWO_SIDED|95.0|0.13|0.46|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.46|0.13|
71656737|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.29|-0.04|
71714398|NCT04211363|142944773|SUPERIORITY||Mean Difference (Final Values)|-25.83|||<|0.0001|TWO_SIDED|95.0|-31.7|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 4||-20.0|-31.7|<0.0001
71714399|NCT04211363|142944773|SUPERIORITY||Mean Difference (Final Values)|-30.9|||<|0.0001|TWO_SIDED|95.0|-37.2|-24.6|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Comparison of change from baseline in PSD score at Week 8||-24.6|-37.2|<0.0001
71714400|NCT03097289|142944774|NON_INFERIORITY|"The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: Null Hypothesis H0: μd ≤ 0 where μd=μT-0.66\*μC Alternate Hypothesis H1: μd \>~Let Xi = (XTi-0.66\*XCi) be a difference if recovery for patient i. The sample mean and standard deviations of these observed differences will be used to construct the lower limit of a 1-sided 97.5% confidence interval."|Mean Difference (Final Values)|8.18|||||ONE_SIDED|97.5|4.03||||||||||4.03|
71714401|NCT03097289|142944775|NON_INFERIORITY|"The acceptance criterion for the survival (days) of platelets is the demonstration of non inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses:~Null Hypothesis H0: μd ≤ 0 where μd = μT-0.58 × μC Alternate Hypothesis H1: μd \> 0"|Mean Difference (Final Values)|0.8|||||ONE_SIDED|97.5|0.39||||||||||0.39|
71714402|NCT01911260|142944780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Growth Deficit who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
71714403|NCT01911260|142944780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Normal Height who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."||||<0.05
71714404|NCT01734902|142944783|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|86.97|STANDARD_ERROR_OF_MEAN|35.6|||TWO_SIDED|90.0|74.046|102.151|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.151|74.046|
71714405|NCT01734902|142944784|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|89.05|STANDARD_ERROR_OF_MEAN|31.2|||TWO_SIDED|90.0|77.26|102.62|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.62|77.26|
71714406|NCT01734902|142944785|EQUIVALENCE|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subject within sequences' was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R [%]|90.03|STANDARD_ERROR_OF_MEAN|29.3|||TWO_SIDED|90.0|78.78|102.88|||||Standard error of the mean is actually intra-individual geometric coefficient variance \[%\]. Statistical analysis is based on PKS which includes 27 subjects.|||102.88|78.78|
71714407|NCT01959932|142944786|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|8.38|||<|0.001|TWO_SIDED|95.0|6.89|10.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||10.20|6.89|<0.001
71714408|NCT01959932|142944787|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS mean ratio|41.63|||<|0.001|TWO_SIDED|95.0|37.75|45.91||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||45.91|37.75|<0.001
71714409|NCT01959932|142944788|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|5.99|||<|0.001|TWO_SIDED|95.0|5.21|6.87||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||6.87|5.21|<0.001
71886868|NCT02634580|143294044|SUPERIORITY||LS Mean Treatment Difference|7.64|STANDARD_ERROR_OF_MEAN|9.88||0.44|TWO_SIDED|95.0|-12.15|27.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe|||27.43|-12.15|0.44
71714410|NCT01959932|142944789|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.45|||<|0.001|TWO_SIDED|95.0|22.0|24.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||24.99|22.00|<0.001
71714411|NCT00758563|142944790|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71714412|NCT00060944|142944791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.734||||0.0302|TWO_SIDED|95.0|0.554|0.974|||Log Rank|||||0.974|0.554|0.0302
71714413|NCT00060944|142944794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.0418|TWO_SIDED|95.0|0.574|0.992|||Log Rank|||||0.992|0.574|0.0418
71714414|NCT00060944|142944795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.192|TWO_SIDED|95.0|0.653|1.09|||Log Rank|||||1.090|0.653|0.1920
71886869|NCT00997516|143294068|SUPERIORITY_OR_OTHER|||||||0.01||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.01
71886870|NCT00997516|143294069|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||||||<0.01
71714415|NCT01138514|142944796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|98.77||||0.05|TWO_SIDED|90.0|95.2|102.5|||Fieller's method|||||102.5|95.2|0.05
71714416|NCT01138514|142944797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|provides 85% power of success|equivalence ratio|100.27||||0.05|TWO_SIDED|90.0|95.6|105.2|||Fieller's method|||||105.2|95.6|0.05
71714417|NCT01138514|142944798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Clinical success was defined as a score of clear (0) or almost clear (1) on Investigators Global Assessment (IGA) at Visit 4/Week 10"|equivalence difference|1.6||||0.05|TWO_SIDED|90.0|-4.2|7.4|||Wald's method Yates' continuity correct|||||7.4|-4.2|0.05
71714418|NCT04549454|142944847|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.598||0.985|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.985
71714419|NCT04549454|142944848|SUPERIORITY||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.618||0.694|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on weekly drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.694
71714420|NCT04549454|142944849|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
71714421|NCT04549454|142944850|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on consequences. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in consequences from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
71714422|NCT04549454|142944851|SUPERIORITY||Mean Difference (Final Values)|-0.265|STANDARD_ERROR_OF_MEAN|0.414||0.523|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.523
71767303|NCT04575597|143036293|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.2|1.36||||||||1.36|0.20|
71886871|NCT00997516|143294078|SUPERIORITY_OR_OTHER|||||||0.86||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Overall body satisfaction||||0.86
71767304|NCT04575597|143036293|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.29|1.89||||||||1.89|0.29|
71767305|NCT04575597|143036293|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.68|1.2||||||||1.20|0.68|
71767306|NCT04575597|143036294|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.09|1.33||||||||1.33|0.09|
71886872|NCT00997516|143294078|SUPERIORITY_OR_OTHER|||||||0.18||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Damage to body||||0.18
71886873|NCT00997516|143294078|SUPERIORITY_OR_OTHER|||||||0.04||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Physical attractiveness||||0.04
71886874|NCT00997516|143294078|SUPERIORITY_OR_OTHER|||||||0.34||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Masculinity/femininity||||0.34
71886875|NCT00997516|143294078|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|Wilcoxon (Mann-Whitney)|||Looking at oneself naked||||0.63
71886876|NCT00997516|143294079|SUPERIORITY_OR_OTHER|||||||0.48||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of abdomen||||0.48
71886877|NCT00997516|143294079|SUPERIORITY_OR_OTHER|||||||0.09||||||Significant at p\<0.05|t-test, 2 sided|||Cosmetic appearance of scars||||0.09
71886878|NCT00997516|143294079|SUPERIORITY_OR_OTHER|||||||0.25||||||Significant at p\<0.05|t-test, 2 sided|||Satisfaction with scars||||0.25
71714423|NCT04549454|142944852|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.427||0.981|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on peak drinks. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.981
71714424|NCT04549454|142944853|SUPERIORITY||Median Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.327||0.889|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 1-month follow-up in the Intervention Arm versus the Control Arm.||||.889
71714425|NCT04549454|142944854|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.338||0.582|TWO_SIDED||||||Tukey-Kramer|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, in examining Time\*Arm interactions on HED. To probe the significant Time\*Arm interaction, a Tukey post-hoc test examined the change in HED from baseline to the 6-month follow-up in the Intervention Arm versus the Control Arm.||||.582
71767307|NCT04575597|143036294|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.15||||||||2.15|0.30|
71767308|NCT04575597|143036294|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.18|1.48||||||||1.48|0.18|
71767309|NCT04575597|143036294|OTHER|Hazard ratio and associated CIs were based on Cox regression model with Efron's method of tie handling with treatment and randomization stratification factors as covariates.|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.62|1.04||||||||1.04|0.62|
71767310|NCT04575597|143036295|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.04|||||TWO_SIDED|95.0|0.59|15.59||||||||15.59|0.59|
71714426|NCT03110562|142944859|SUPERIORITY||Hazard Ratio (HR)|0.702||||0.0075|TWO_SIDED|95.0|0.5279|0.9335||One Sided P-value|Stratified Log-rank Test|Stratified for prior PI therapies, number of prior of anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||0.9335|0.5279|0.0075
71767311|NCT04575597|143036295|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.29|6.16||||||||6.16|0.29|
71886879|NCT00997516|143294079|SUPERIORITY_OR_OTHER|||||||0.81||||||Significant at p\<0.05|t-test, 2 sided|||Discomfort of scars||||0.81
71714427|NCT03110562|142944860|SUPERIORITY||Odds Ratio (OR)|1.9626||||0.0012|TWO_SIDED|95.0|1.2641|3.0471||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||3.0471|1.2641|0.0012
71714428|NCT03110562|142944861|SUPERIORITY||Odds Ratio (OR)|1.6594||||0.0082|TWO_SIDED|95.0|1.0993|2.5049||One Sided P-value|Cochran-Mantel-Haenszel|Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.||||2.5049|1.0993|0.0082
71767312|NCT04575597|143036295|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.37|||||TWO_SIDED|95.0|0.09|1.44||||||||1.44|0.09|
71767313|NCT04575597|143036295|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.62|2.3||||||||2.30|0.62|
71767314|NCT04575597|143036296|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|1.14|11.88||||||||11.88|1.14|
71886880|NCT00997516|143294079|SUPERIORITY_OR_OTHER||||||<|0.01||||||Significant at p\<0.05|t-test, 2 sided|||Overall impression of scars||||<0.01
71886881|NCT01394705|143294115|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||.65
71767315|NCT04575597|143036296|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.34|3.98||||||||3.98|0.34|
71767316|NCT04575597|143036296|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||||2.68|0.27|
71886882|NCT01394705|143294115|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71886883|NCT01394705|143294116|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71886884|NCT04317274|143294131|OTHER||Slope|-0.19||||0.21|TWO_SIDED||||||Mixed Models Analysis|Note: original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the high cholesterol group.||||0.21
71886885|NCT04317274|143294131|OTHER||Slope|-1.23|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Original plan was to conduct ANOVAs, but failed tests of assumptions||We tested for interaction effect of order and video version within the colorectal cancer group.||||<0.001
71886886|NCT04317274|143294132|OTHER||Slope|0.58|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient|||We examined the correlation between SDM Process and SDM-Q9 scores in the high cholesterol group.||||<.001
71886887|NCT04317274|143294132|OTHER||Slope|0.71|||<|0.001|TWO_SIDED||||||Pearson's correlation coefficient]|||We examined the correlation between SDM Process and SDM-Q9 scores in the colorectal cancer group.||||<.001
71714429|NCT03110562|142944862|SUPERIORITY||Odds Ratio (OR)|0.5042||||0.0013|TWO_SIDED|95.0|0.3216|0.7906||One Sided P-value|Cochran-Mantel-Haenszel||Stratified by Prior PI therapies (Yes or No), Number of prior anti-MM regimens (1 or \>1), and R-ISS stage at study entry (R-ISS Stage III versus R-ISS Stage I or II).|||0.7906|0.3216|0.0013
71714430|NCT03110562|142944863|SUPERIORITY||Hazard Ratio (HR)|0.8764||||0.2152|TWO_SIDED|95.0|0.6313|1.2168||One Sided P-value|Stratified log-rank test|Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.|Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.|||1.2168|0.6313|0.2152
71714431|NCT05788991|142944890|NON_INFERIORITY|Difference of proportions between groups (with 95% CI) and a non inferiority margin of 15 percentage points, assuming a 1-sided α = .025 and 80% power|Farrington-Manning test|-0.5|||<|0.025|ONE_SIDED|95.0|-10.8|||1 sided alpha|Farrington-Manning test|||The outcome measure of the primary objective was a noninferiority margin of 15 percentage points in the absolute difference in clinical cure rates between dequalinium chloride and metronidazole 7 to 11 days after start of treatment.|||-10.8|<.025
71714432|NCT05270863|142944897|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<.001
71714433|NCT04464473|142944898|SUPERIORITY|||||||0.5736|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.5736
71714434|NCT04464473|142944898|SUPERIORITY|||||||0.304|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.304
71714435|NCT04464473|142944898|SUPERIORITY|||||||0.0545|||||||ANOVA|The main effect of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0545
71714436|NCT04464473|142944898|SUPERIORITY|||||||0.1134|||||||ANOVA|Interaction of visit (Baseline, FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.1134
71714437|NCT04464473|142944898|SUPERIORITY|||||||0.4326|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of MFG efferent connectivity||||||0.4326
71714438|NCT04464473|142944898|SUPERIORITY|||||||0.2546|||||||ANOVA|The interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and subsystem (Temporal, Contextual Control) on the magnitude of MFG efferent connectivity||||||0.2546
71714439|NCT04464473|142944898|SUPERIORITY|||||||0.0645|||||||ANOVA|The main effect of intervention (FPl-TMS, MFG-TMS, S1-TMS) on the overall magnitude of FPl efferent connectivity||||||0.0645
71714440|NCT04464473|142944898|SUPERIORITY|||||||0.2033|||||||ANOVA|Interaction of intervention (FPl-TMS, MFG-TMS, S1-TMS) and Subsystem on the magnitude of FPl efferent connectivity||||||0.2033
71714441|NCT04464473|142944899|SUPERIORITY|||||||0.8152|||||||ANOVA|Main effect of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) on overall BOLD actviation.||||||0.8152
71714442|NCT04464473|142944899|SUPERIORITY|||||||0.0085|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.0085
71714443|NCT04464473|142944899|SUPERIORITY|||||||0.1551|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1551
71714444|NCT04464473|142944899|SUPERIORITY|||||||0.6431|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6431
71767317|NCT04575597|143036296|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|0.96|2.39||||||||2.39|0.96|
71714445|NCT04464473|142944899|SUPERIORITY|||||||0.2447|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.2447
71714446|NCT04464473|142944899|SUPERIORITY|||||||0.0002|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.0002
71714447|NCT04464473|142944899|SUPERIORITY|||||||0.1339|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem on BOLD activation||||||0.1339
71714448|NCT04464473|142944899|SUPERIORITY|||||||0.1315|||||||ANOVA|Interaction of visit, temporal control, contextual control, and subsystem on BOLD activation||||||0.1315
71714449|NCT04464473|142944899|SUPERIORITY|||||||0.6836|||||||ANOVA|The main effect of intervention arm (FPl-TMS, MFG-TMS, S1-TMS) on overall BOLD activation.||||||0.6836
71714450|NCT04464473|142944899|SUPERIORITY|||||||0.2146|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and subsystem (temporal, contextual, sensorimotor control) on overall BOLD activation.||||||0.2146
71714451|NCT04464473|142944899|SUPERIORITY|||||||0.1541|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on BOLD activation||||||0.1541
71714452|NCT04464473|142944899|SUPERIORITY|||||||0.6657|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on BOLD activation||||||0.6657
71714453|NCT04464473|142944899|SUPERIORITY|||||||0.5619|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on BOLD activation||||||0.5619
71714454|NCT04464473|142944899|SUPERIORITY|||||||0.5148|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5148
71714455|NCT04464473|142944899|SUPERIORITY|||||||0.5428|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), contextual control, and subsystem (temporal, contextual, sensorimotor) on BOLD activation||||||0.5428
71886888|NCT03175549|143294153|SUPERIORITY||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|10.1||0.36|TWO_SIDED|95.0|-10.22|29.38||A priori threshold for significance was 0.05.|Mixed Models Analysis||Standard error was calculated using bootstrap methods which is considered best for MEM.|||29.38|-10.22|0.36
71886889|NCT03175549|143294154|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03|<|0.025|TWO_SIDED||||||t-test, 2 sided|||Posted results show mean change in drinking for the drug group relative to placebo for each day of the 11 days of ad libidum drinking (Days 1-11) permitted during the 14 days (2 weeks) of medication.||||<0.025
71886890|NCT03175549|143294154|SUPERIORITY||Slope|-0.067|STANDARD_ERROR_OF_MEAN|0.03||0.025|TWO_SIDED||||||Mixed Models Analysis|473 daily observations within 43 individuals.|The apremilast group showed a significantly more rapid reduction in drinks per day relative to placebo.|||||0.025
71714456|NCT04464473|142944899|SUPERIORITY|||||||0.1249|||||||ANOVA|Interaction of intervention, temporal control, contextual control, and subsystem on BOLD activation||||||0.1249
71714457|NCT04464473|142944900|SUPERIORITY|||||||0.9504|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.9504
71714458|NCT04464473|142944900|SUPERIORITY|||||||0.7318|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7318
71714459|NCT04464473|142944900|SUPERIORITY|||||||0.8424|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control on error rate||||||0.8424
71714460|NCT04464473|142944900|SUPERIORITY|||||||0.7652|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control on error rate||||||0.7652
71714461|NCT04464473|142944901|SUPERIORITY|||||||0.0266|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.0266
71714462|NCT04464473|142944901|SUPERIORITY|||||||0.2386|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.2386
71714463|NCT04464473|142944901|SUPERIORITY|||||||0.4211|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control on error rate||||||0.4211
71714464|NCT04464473|142944901|SUPERIORITY|||||||0.7503|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return) and contextual control on error rate||||||0.7503
71767318|NCT04575597|143036297|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.82|3.45||||||||3.45|0.82|
71767319|NCT04575597|143036297|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.55|2.33||||||||2.33|0.55|
71767320|NCT04575597|143036297|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.27|1.29||||||||1.29|0.27|
71767321|NCT04575597|143036297|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|1.14|2.2||||||||2.20|1.14|
71714465|NCT04464473|142944902|SUPERIORITY|||||||0.0091|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.0091
71714466|NCT04464473|142944902|SUPERIORITY|||||||0.0045|||||||ANOVA|Interaction of Visit (Baseline, MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0045
71767322|NCT04575597|143036298|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|0.73|2.73||||||||2.73|0.73|
71767323|NCT04575597|143036298|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.52|1.94||||||||1.94|0.52|
71767324|NCT04575597|143036298|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.34|1.32||||||||1.32|0.34|
71886891|NCT02435849|143294157|OTHER|testing the null hypothesis that ORR within 3 months is less than or equal to 20%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
71714467|NCT04464473|142944902|SUPERIORITY|||||||0.1082|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), Temporal Control, and Contextual Control on error rate||||||0.1082
71714468|NCT04464473|142944902|SUPERIORITY|||||||0.0659|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1), phase (sub-task, return), Temporal Control, and Contextual Control on error rate||||||0.0659
71714469|NCT04464473|142944903|SUPERIORITY|||||||0.0211|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.0211
71714470|NCT04464473|142944903|SUPERIORITY|||||||0.4964|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.4964
71714471|NCT04464473|142944903|SUPERIORITY|||||||0.3129|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and temporal control in reaction time||||||0.3129
71714472|NCT04464473|142944903|SUPERIORITY|||||||0.5439|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and temporal control in reaction time||||||0.5439
71714473|NCT04464473|142944904|SUPERIORITY|||||||0.0344|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0344
71714474|NCT04464473|142944904|SUPERIORITY|||||||0.5113|||||||ANOVA|Interaction between visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.5113
71714475|NCT04464473|142944904|SUPERIORITY|||||||0.0301|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS) and contextual control in reaction time||||||0.0301
71714476|NCT04464473|142944904|SUPERIORITY|||||||0.6931|||||||ANOVA|Interaction between intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), and contextual control in reaction time||||||0.6931
71714477|NCT04464473|142944905|SUPERIORITY|||||||0.0189|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.0189
71714478|NCT04464473|142944905|SUPERIORITY|||||||0.0763|||||||ANOVA|Interaction of visit (Baseline, MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.0763
71886892|NCT02435849|143294159|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
71886893|NCT02435849|143294160|OTHER|testing the null hypothesis that ORR with MRD negative within 3 months is less than or equal to 15%|||||<|0.0001|||||||Clopper-Pearson|||||||<.0001
71828084|NCT01157182|143160603|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.67|||||TWO_SIDED|90.0|92.68|98.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.77|92.68|
71714479|NCT04464473|142944905|SUPERIORITY|||||||0.9701|||||||ANOVA|Interaction of intervention (MFG-cTBS, FPl-cTBS, S1-cTBS), temporal control, and contextual control on reaction time||||||0.9701
71714480|NCT04464473|142944905|SUPERIORITY|||||||0.3826|||||||ANOVA|Interaction of intervention(MFG-cTBS, FPl-cTBS, S1-cTBS), phase (sub-task, return), temporal control, and contextual control on reaction time||||||0.3826
71714481|NCT01334918|142944908|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Predefined noninferiority criterion: If the lower boundary of the 95% CI was within 0.15 of 0.78, MDCT would be determined to be noninferior to SPECT.|Agreement rate|0.87|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|0.77|0.97||||||Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.||0.97|0.77|
71714482|NCT01334918|142944913|SUPERIORITY_OR_OTHER_LEGACY||Specificity|0.95|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.9|0.99||||||Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.||0.99|0.90|
71714483|NCT01334918|142944913|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|0.77|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|0.54|1.0||||||Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.||1.00|0.54|
71714484|NCT01409096|142944963|SUPERIORITY_OR_OTHER|||||||0.9084|TWO_SIDED||||||ANCOVA|||Baseline HRSD scores used as covariate.||||0.9084
71714485|NCT01409096|142944964|SUPERIORITY_OR_OTHER|||||||0.5187|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.5187
71714486|NCT01409096|142944965|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||ANOVA|||Baseline YMRS used as a covariate.||||0.6060
71714487|NCT01409096|142944966|SUPERIORITY_OR_OTHER|||||||0.511|TWO_SIDED||||||ANCOVA|||Baseline HRSA used as a covariate.||||0.5110
71714488|NCT01155050|142944981|SUPERIORITY|||||||0.296|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.296
71714489|NCT01155050|142944982|SUPERIORITY|||||||0.787|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.787
71714490|NCT01155050|142944983|SUPERIORITY|||||||0.34|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.340
71714491|NCT01155050|142944984|SUPERIORITY|||||||0.502|||||||ANOVA|||The null hypothesis is that there are no differences in the outcome across groups.||||.502
71767325|NCT04575597|143036298|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|1.03|1.78||||||||1.78|1.03|
71828085|NCT01157182|143160604|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.73|||||TWO_SIDED|90.0|92.68|98.88|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.88|92.68|
71714492|NCT01155050|142944985|SUPERIORITY|||||||0.86|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.860
71714493|NCT01155050|142944986|SUPERIORITY|||||||0.634|||||||ANOVA|||The null hypothesis is that the outcome does not differ across the four groups.||||.634
71714494|NCT01155050|142944987|SUPERIORITY|||||||0.879|||||||ANOVA|||The null hypothesis is that there is no difference in the outcome across the four treatment groups.||||.879
71714495|NCT00949533|142944995|SUPERIORITY_OR_OTHER|||||||0.825|||||||Pearson Chi-Square|||||||0.825
71714496|NCT00949533|142944996|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||> 0.05
71714497|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Cough: statistical difference between 2 groups was based on chi-squared test.||||1.000
71714498|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||0.284|||||||Chi-squared|||Rhinorrhea: statistical difference between 2 groups was based on chi-squared test.||||0.284
71714499|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sore throat: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71714500|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Shortness of breath: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71714501|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||0.487|||||||Fisher Exact|||Diarrhea: statistical difference between 2 groups was based on fisher-exact test.||||0.487
71714502|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||Headache: statistical difference between 2 groups was based on fisher-exact test.||||0.593
71714503|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71714504|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Vomiting: statistical difference between 2 groups was based on fisher-exact test.||||1.000
71714505|NCT00949533|142944997|SUPERIORITY_OR_OTHER|||||||0.106|||||||Fisher Exact|||Other: statistical difference between 2 groups was based on fisher-exact test.||||0.106
71767326|NCT04575597|143036299|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.35|1.66||||||||1.66|0.35|
71714506|NCT01959529|142944999|NON_INFERIORITY|Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR\<1.3 was less than 2.5%.|Hazard Ratio (HR)|0.908|||<|0.001|TWO_SIDED|95.0|0.781|1.055||p value : Refers to one-sided test of HR \>= 1.3 (against Ha: HR\<1.3).|Regression, Cox|||The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.||1.055|0.781|<0.001
71714507|NCT01959529|142945000|SUPERIORITY||Rate ratio|0.601|||<|0.001|TWO_SIDED|95.0|0.476|0.759||p-value : Refers to one-sided test of RR \>= 1.0 (against Ha: RR\<1.0)|Negative binomial regression|The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS.||Superiority was considered confirmed if the upper limit of the two-sided 95% confidence interval for the rate ratio (RR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: RR ≥1.0 against Ha: RR \<1.0, was less than 2.5%||0.759|0.476|<0.001
71714508|NCT01959529|142945001|SUPERIORITY||Odds Ratio (OR)|0.729|||<|0.001|TWO_SIDED|95.0|0.6|0.866||p-value: Refers to one-sided test of OR \>= 1.0 (against Ha: OR\<1.0)|Regression, Logistic|The model was logistic regression with log-link function.The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS||Superiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the odds ratio (OR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: OR ≥1.0 against Ha: OR\<1.0, was less than 2.5%.||0.866|0.600|<0.001
71714509|NCT00557193|142945004|SUPERIORITY||Hazard Ratio (HR)|1.107||||0.672|ONE_SIDED|85.0||1.403||A priori significance level threshold of alpha=0.15|Log Rank||Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio|A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR\<1.||1.403||0.672
71714510|NCT00652834|142945017|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.05|TWO_SIDED|95.0||||The p value is only for GSRS score comparison only.|t-test, 2 sided||The GSRS range is 1-7|"The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).~There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation."||||0.05
71714511|NCT00976456|142945023|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.|Hazard Ratio (HR)|1.29||||0.0583|TWO_SIDED|95.0|0.989|1.682|||Wilcoxon (Mann-Whitney)|||||1.682|0.989|0.0583
71714512|NCT00976456|142945024|NON_INFERIORITY_OR_EQUIVALENCE|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 - 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.|Hazard Ratio (HR)|1.091||||0.3869|TWO_SIDED|95.0|0.794|1.499|||Wilcoxon (Mann-Whitney)|||||1.499|0.794|0.3869
71714513|NCT02037529|142945027|SUPERIORITY|||||||0.5623|||||||Log Rank|||||||0.5623
71714514|NCT02037529|142945032|SUPERIORITY|||||||0.984|||||||Log Rank|||||||0.9840
71714515|NCT02037529|142945033|SUPERIORITY|||||||0.5968|||||||Log Rank|||||||0.5968
71714516|NCT00718315|142945041|SUPERIORITY_OR_OTHER|||||||0.481||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.481
71714517|NCT00718315|142945041|SUPERIORITY_OR_OTHER|||||||0.933||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.933
71714518|NCT00718315|142945041|SUPERIORITY_OR_OTHER|||||||0.986||||||Test for Binomial Ratio, where H0: P \>=61%; Ha: P \< 61% (One-tailed Test)|t-test, 1 sided|||||||0.986
71714519|NCT00718315|142945043|SUPERIORITY_OR_OTHER|||||||0.095|||||||Log Rank|||||||0.095
71714520|NCT00718315|142945044|SUPERIORITY_OR_OTHER|||||||0.199|||||||Chi-squared|||||||0.199
71714521|NCT00718315|142945045|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||||||0.108
71714522|NCT00718315|142945046|SUPERIORITY_OR_OTHER|||||||0.179|||||||Chi-squared|||||||0.179
71714523|NCT00718315|142945047|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
71714524|NCT00718315|142945048|SUPERIORITY_OR_OTHER|||||||0.087|||||||Kruskal-Wallis|||||||0.087
71714525|NCT00718315|142945049|SUPERIORITY_OR_OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
71714526|NCT01170663|142945050|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.807||||0.0169|TWO_SIDED|95.0|0.678|0.962|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.962|0.678|0.0169
71714527|NCT01170663|142945051|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.635|||<|0.0001|TWO_SIDED|95.0|0.536|0.752|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.752|0.536|<0.0001
71714528|NCT01170663|142945052|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.596|||<|0.0001|TWO_SIDED|95.0|0.494|0.72|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.||||0.720|0.494|<0.0001
71714529|NCT01170663|142945054|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.0001|TWO_SIDED|95.0|1.45|3.16|||Cochran-Mantel-Haenszel|Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.||||3.16|1.45|0.0001
71828086|NCT01157182|143160605|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.21|||||TWO_SIDED|90.0|84.62|98.31|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.31|84.62|
71714530|NCT01170663|142945062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.|ANCOVA|||||||0.3973
71828087|NCT01157182|143160606|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.11|||||TWO_SIDED|90.0|89.04|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|89.04|
71828088|NCT01157182|143160607|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.48|||||TWO_SIDED|90.0|90.7|104.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.76|90.70|
71828089|NCT01157182|143160608|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|89.78|98.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.81|89.78|
71828090|NCT01157182|143160609|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.99|||||TWO_SIDED|90.0|92.73|99.36|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.36|92.73|
71828091|NCT01157182|143160610|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.22|||||TWO_SIDED|90.0|93.62|100.96|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.96|93.62|
71714531|NCT01128569|142945091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||||TWO_SIDED|95.0|0.087|0.237||||||||0.237|0.087|
71714532|NCT01128569|142945091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0|0.069|0.222||||||||0.222|0.069|
71714533|NCT01128569|142945091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-0.091|0.057||||||||0.057|-0.091|
71714534|NCT02519842|142945096|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|-7.6|27.9|||||Mean difference in percentage of participants who experienced at least 1 tier 2 AE and received fosaprepitant regimen compared with participants who received control regimen.|||27.9|-7.6|
71714535|NCT02519842|142945097|OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-5.1|17.8|||||Mean difference in percentage of participants who discontinued due to an AE and received fosaprepitant regimen compared with participants who received control regimen.|||17.8|-5.1|
71714536|NCT01977222|142945180|OTHER|||||||0.1673|||||||t-test, 2 sided|||||||0.1673
71714537|NCT01977222|142945181|OTHER|||||||0.5745|||||||t-test, 2 sided|||||||0.5745
71714538|NCT01977222|142945182|OTHER|||||||0.511|||||||t-test, 2 sided|||||||.511
71714539|NCT01977222|142945183|OTHER|||||||0.776|||||||t-test, 2 sided|||||||0.776
71714540|NCT01977222|142945184|OTHER|||||||0.5374|||||||t-test, 2 sided|||||||0.5374
71714541|NCT01977222|142945185|OTHER|||||||0.3385|||||||t-test, 2 sided|||||||0.3385
71714542|NCT01977222|142945186|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
71714543|NCT01977222|142945187|OTHER|||||||0.1183|||||||t-test, 2 sided|||||||0.1183
71714544|NCT01605669|142945200|SUPERIORITY_OR_OTHER||Percentage Sensitivity|85.7||||||95.0||||||||||||
71714545|NCT01605669|142945200|SUPERIORITY_OR_OTHER||Percent Specificity|72.4||||||95.0||||||||||||
71714546|NCT01605669|142945200|SUPERIORITY_OR_OTHER||Percent Error Rate|25.0||||||95.0|||||||Error rate of 9/36 is equal to total of false positives plus false negatives over the total of participants analyzed.|||||
71714547|NCT00945659|142945201|SUPERIORITY||Mean Difference (Net)|-0.003|STANDARD_DEVIATION|0.2||0.86|TWO_SIDED|95.0|-0.43|0.36|||Generalized Estimating Equation|||||0.36|-0.43|0.86
71714548|NCT00945659|142945201|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.03|TWO_SIDED|95.0|-0.78|-0.04|||Generalized Estimating Equation|||||-0.04|-0.78|0.03
71714549|NCT00945659|142945202|SUPERIORITY||Mean Difference (Net)|-10.05|STANDARD_DEVIATION|4.72||0.03|TWO_SIDED|95.0|-19.3|-0.81|||Generalized Estimating Equation|||||-0.81|-19.30|0.03
71714550|NCT00945659|142945202|SUPERIORITY||Mean Difference (Net)|-0.82|STANDARD_DEVIATION|5.47||0.88|TWO_SIDED|95.0|-11.54|9.9|||Generalized Estimating Equation|||||9.9|-11.54|0.88
71828092|NCT01157182|143160611|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.73|||||TWO_SIDED|90.0|84.46|99.62|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.62|84.46|
71828093|NCT01157182|143160612|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.47|||||TWO_SIDED|90.0|88.37|103.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.14|88.37|
71714551|NCT00945659|142945203|SUPERIORITY||Generalized Estimating Equation|-3.45|STANDARD_DEVIATION|4.98||0.49|TWO_SIDED|95.0|-13.21|6.32|||Generalized Estimating Equation|||||6.32|-13.21|0.49
71714552|NCT00945659|142945203|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_DEVIATION|5.76||0.66|TWO_SIDED|95.0|||||Generalized Estimating Equation|||||||0.66
71714553|NCT00945659|142945204|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|0.86||0.64|TWO_SIDED|95.0|-1.29|2.08|||Generalized Estimating Equation|||||2.08|-1.29|0.64
71714554|NCT00945659|142945204|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.92||0.65|TWO_SIDED|95.0|-2.22|1.39|||Generalized Estimating Equation|||||1.39|-2.22|0.65
71714555|NCT00945659|142945205|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_DEVIATION|63.4||0.99|TWO_SIDED|95.0|-123.56|124.97|||Generalized Estimating Equation|||||124.97|-123.56|0.99
71714556|NCT00945659|142945205|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_DEVIATION|13.81||0.93|TWO_SIDED|95.0|-28.26|25.83|||Generalized Estimating Equation|||||25.83|-28.26|0.93
71714557|NCT00945659|142945206|SUPERIORITY||Mean Difference (Net)|1.17|STANDARD_DEVIATION|1.47||0.43|TWO_SIDED|95.0|-1.7|4.04|||Generalized Estimating Equation|||||4.04|-1.70|0.43
71714558|NCT00945659|142945206|SUPERIORITY||Mean Difference (Net)|-2.59|STANDARD_DEVIATION|1.87||0.08|TWO_SIDED|95.0|-5.5|0.32|||Generalized Estimating Equation|||||0.32|-5.50|0.08
71828094|NCT01157182|143160613|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.63|||||TWO_SIDED|90.0|88.1|103.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.81|88.10|
71714559|NCT00945659|142945207|SUPERIORITY||Mean Difference (Net)|1.32|STANDARD_DEVIATION|1.66||0.43|TWO_SIDED|95.0|-1.94|4.56|||Generalized Estimating Equation|||||4.56|-1.94|0.43
71767327|NCT04575597|143036299|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.38|1.79||||||||1.79|0.38|
71714560|NCT00945659|142945207|SUPERIORITY||Mean Difference (Net)|-3.71|STANDARD_DEVIATION|1.36||0.007|TWO_SIDED|95.0|-6.38|-1.04|||Generalized Estimating Equation|||||-1.04|-6.38|.007
71714561|NCT00945659|142945208|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.23||0.75|TWO_SIDED|95.0|-2.02|2.79|||Generalized Estimating Equation|||||2.79|-2.02|0.75
71714562|NCT00945659|142945208|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_DEVIATION|1.38||0.78|TWO_SIDED|95.0|-3.09|2.32|||Generalized Estimating Equation|||||2.32|-3.09|0.78
71714563|NCT00945659|142945209|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_DEVIATION|1.31||0.58|TWO_SIDED|95.0|-1.86|3.29|||Generalized Estimating Equation|||||3.29|-1.86|0.58
71714564|NCT00945659|142945209|SUPERIORITY||Mean Difference (Net)|-0.93|STANDARD_DEVIATION|1.14||0.41|TWO_SIDED|95.0|-3.17|1.3|||Generalized Estimating Equation|||||1.3|-3.17|0.41
71714565|NCT00945659|142945210|SUPERIORITY||Mean Difference (Net)|1.95|STANDARD_DEVIATION|2.66||0.46|TWO_SIDED|95.0|-3.26|7.15|||Generalized Estimating Equation|||||7.15|-3.26|0.46
71714566|NCT00945659|142945210|SUPERIORITY||Mean Difference (Net)|-3.01|STANDARD_DEVIATION|2.54||0.24|TWO_SIDED|95.0|-7.99|1.96|||Generalized Estimating Equation|||||1.96|-7.99|0.24
71714567|NCT00945659|142945211|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_DEVIATION|3.37||0.93|TWO_SIDED|95.0|-6.33|6.91|||Generalized Estimating Equation|||||6.91|-6.33|0.93
71714568|NCT00945659|142945211|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_DEVIATION|2.95||0.45|TWO_SIDED|95.0|-8.01|3.57|||Generalized Estimating Equation|||||3.57|-8.01|0.45
71714569|NCT00945659|142945212|SUPERIORITY||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|3.26||0.81|TWO_SIDED|95.0|-7.15|5.62|||Generalized Estimating Equestion|||||5.62|-7.15|0.81
71714570|NCT00945659|142945212|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.63||0.72|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.72
71714571|NCT00945659|142945213|SUPERIORITY||Mean Difference (Net)|0.99|STANDARD_DEVIATION|2.6||0.71|TWO_SIDED|95.0|-4.11|6.08|||Generalized Estimating Equation|||||6.08|-4.11|0.71
71714572|NCT00945659|142945213|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|2.85||0.68|TWO_SIDED|95.0|-6.74|4.43|||Generalized Estimating Equation|||||4.43|-6.74|0.68
71714573|NCT04562116|142945214|OTHER||Ratio|94.59||||0.5789|TWO_SIDED|90.0|79.57|112.45||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||112.45|79.57|0.5789
71714574|NCT04562116|142945214|OTHER||Ratio|99.34||||0.9468|TWO_SIDED|90.0|83.66|117.96||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.96|83.66|0.9468
71828095|NCT01157182|143160614|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.15|||||TWO_SIDED|90.0|89.56|98.98|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||98.98|89.56|
71828096|NCT01157182|143160615|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.01|||||TWO_SIDED|90.0|92.14|100.04|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.04|92.14|
71828097|NCT01157182|143160616|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.75|||||TWO_SIDED|90.0|92.75|100.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||100.93|92.75|
71828098|NCT05382104|143160690|EQUIVALENCE|A linear mixed-effects model was applied to natural log (ln)-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90 percent (%) confidence intervals (CIs) was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|76.62|||||TWO_SIDED|90.0|71.78|81.78|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||81.78|71.78|
71828099|NCT05382104|143160690|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed Cmax with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|71.61|||||TWO_SIDED|90.0|67.14|76.37|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||76.37|67.14|
71828100|NCT05382104|143160691|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.13|||||TWO_SIDED|90.0|80.74|87.66|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||87.66|80.74|
71828101|NCT05382104|143160691|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUClast with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.35|||||TWO_SIDED|90.0|83.87|90.96|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||90.96|83.87|
71828102|NCT05382104|143160692|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for the differences between Treatment B versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment B versus Treatment A.|Geometric Mean Ratio (%)|84.74|||||TWO_SIDED|90.0|81.28|88.34|||||Geometric mean ratio (%) was calculated as 100\*(Treatment B / Treatment A).|||88.34|81.28|
71714575|NCT04562116|142945214|OTHER||Ratio|107.81||||0.1364|TWO_SIDED|90.0|99.14|117.24||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.24|99.14|0.1364
71886894|NCT04849780|143294193|NON_INFERIORITY|It was calculated that 80 participants randomized in a 1:1 fashion between the two arms would have at least 80% power to detect a 5 points difference in mean change from baseline overall comfort. Sample size was determined using a 2-sided Satterthwaite t-test assuming unequal variances with an alpha level of 5%. A non-inferiority margin of -5 points was used.|Population Mean Difference|29.279|||||TWO_SIDED|95.0|24.602|33.732|||Bootstrapping methods||Population Mean difference was calculated as Arm 1 minus Arm 2|||33.732|24.602|
71886895|NCT04849780|143294194|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of 3 points was used.|LS Mean|-10.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-12.7|-8.6|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 1 minus Arm 2 (subjects' own contact lens)|||-8.6|-12.7|
71714576|NCT04562116|142945214|OTHER||Ratio|92.13||||0.1915|TWO_SIDED|90.0|82.85|102.44||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||102.44|82.85|0.1915
71714577|NCT04562116|142945214|OTHER||Ratio|101.67||||0.5059|TWO_SIDED|90.0|97.41|106.12||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||106.12|97.41|0.5059
71714578|NCT04562116|142945215|OTHER||Ratio|95.82||||0.6665|TWO_SIDED|90.0|80.72|113.75||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||113.75|80.72|0.6665
71714579|NCT04562116|142945215|OTHER||Ratio|99.15||||0.9316|TWO_SIDED|90.0|83.43|117.83||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||117.83|83.43|0.9316
71714580|NCT04562116|142945215|OTHER||Ratio|107.75||||0.1371|TWO_SIDED|90.0|99.12|117.13||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||117.13|99.12|0.1371
71714581|NCT04562116|142945215|OTHER||Ratio|88.66||||0.0962|TWO_SIDED|90.0|78.72|99.85||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||99.85|78.72|0.0962
71714582|NCT04562116|142945215|OTHER||Ratio|100.81||||0.6807|TWO_SIDED|90.0|97.45|104.29||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.29|97.45|0.6807
71714583|NCT04562116|142945216|OTHER||Ratio|91.22||||0.3431|TWO_SIDED|90.0|77.3|107.63||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Caffeine||107.63|77.30|0.3431
71714584|NCT04562116|142945216|OTHER||Ratio|91.05||||0.4277|TWO_SIDED|90.0|74.33|111.53||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Metoprolol Tartrate||111.53|74.33|0.4277
71714585|NCT04562116|142945216|OTHER||Ratio|94.79||||0.4963|TWO_SIDED|90.0|82.8|108.52||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Midazolam||108.52|82.80|0.4963
71714586|NCT04562116|142945216|OTHER||Ratio|88.24||||0.1931|TWO_SIDED|90.0|75.08|103.7||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Omeprazole||103.70|75.08|0.1931
71714587|NCT04562116|142945216|OTHER||Ratio|92.94||||0.296|TWO_SIDED|90.0|82.51|104.69||A linear mixed-effect model was used to compare the natural log-transformed of the value, with substrate with or without Nemolizumab as the fixed effect and subject as a random effect.|Mixed Models Analysis|||Warfarin Sodium||104.69|82.51|0.2960
71714588|NCT00833521|142945244|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|91.1||||||90.0|86.3|96.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||96.1|86.3|
71714589|NCT00833521|142945245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.0||||||90.0|91.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|91.0|
71714590|NCT00833521|142945246|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.8||||||90.0|90.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|90.7|
71714591|NCT01405196|142945262|SUPERIORITY||Odds Ratio (OR)|2.23||||0.076|TWO_SIDED|90.0|0.89|5.62||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.62|0.89|0.076
71714592|NCT01405196|142945262|SUPERIORITY||Odds Ratio (OR)|0.96||||0.528|TWO_SIDED|90.0|0.38|2.41||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.41|0.38|0.528
71714593|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|2.77|||||TWO_SIDED|90.0|0.62|12.4||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||12.40|0.62|
71714594|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|90.0|0.31|7.71||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.71|0.31|
71714595|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|90.0|0.4|2.67||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.67|0.40|
71714596|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|90.0|0.29|2.05||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.05|0.29|
71714597|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|90.0|0.35|2.24||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.24|0.35|
71714598|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|0.44|||||TWO_SIDED|90.0|0.16|1.16||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.16|0.16|
71714599|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|90.0|0.64|4.09||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.09|0.64|
71828103|NCT05382104|143160692|EQUIVALENCE|A linear mixed-effects model was applied to ln-transformed AUC0-infinity with treatment, period, and sequence as fixed effects, and participant within sequence as a random effect. Point estimates and their associated 90% CIs was constructed for differences between Treatment C versus Treatment A. The point estimates and their associated 90% CIs were then back transformed to provide point estimates and 90% CIs for ratios of Treatment C versus Treatment A.|Geometric Mean Ratio (%)|87.84|||||TWO_SIDED|90.0|84.3|91.53|||||Geometric mean ratio (%) was calculated as 100\*(Treatment C / Treatment A).|||91.53|84.30|
71828104|NCT03506880|143160698|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that drinking would increase from baseline to 12-month follow-up for those in the AC, but not for those in the SG and MADD conditions.||||>0.05
71828105|NCT03506880|143160699|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was also hypothesized that teens in the SG and MADD conditions would report significantly more declining rides with impaired drivers than those in the AC group.||||<0.01
71828106|NCT03506880|143160700|SUPERIORITY||Mean Difference (Final Values)|0.06|||>|0.01|TWO_SIDED||||||Tukey's Post-Hoc||Estimation parameter used to determine significance between mean values in MADD, SG, and AC group.|It was hypothesized that participants in the MADD and SG groups would be significantly less willing to ride in a car with an impaired driver than those in the AC group.||||>0.01
71828107|NCT00367055|143160724|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p value is for Total AUC(0-10 min)|Van Elteren|||||||0.376
71886896|NCT04849780|143294195|NON_INFERIORITY|Sample size was determined based on the primary hypothesis only. A non-inferiority margin of -5 points was used.|LS Mean|25.9|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|19.0|32.9|||Heterogeneous Mixed model analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Arm 2 (senofilcon A), minus Arm 2 (subjects' own contact lens)|||32.9|19.0|
71714600|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|90.0|0.27|1.77||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.77|0.27|
71714601|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|1.95|||||TWO_SIDED|90.0|0.78|4.84||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.84|0.78|
71714602|NCT01405196|142945263|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.38|2.32||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.32|0.38|
71714603|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|90.0|0.28|3.88||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.88|0.28|
71714604|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.19|3.01||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.01|0.19|
71714605|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|90.0|0.28|1.85||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.85|0.28|
71714606|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|90.0|0.32|2.02||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.02|0.32|
71714607|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.3|1.83||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.83|0.30|
71714608|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|0.45|||||TWO_SIDED|90.0|0.18|1.13||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.13|0.18|
71714609|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|90.0|0.58|3.6||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.60|0.58|
71828108|NCT00367055|143160724|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||p value is for Incremental AUC(0-10 min)|Van Elteren|||||||0.990
71828109|NCT02459899|143160734|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.139||0.07|TWO_SIDED|95.0|-0.53|0.02||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||0.02|-0.53|0.07
71828110|NCT02459899|143160734|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-0.75|-0.22||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.22|-0.75|<0.001
71886897|NCT04849780|143294196|NON_INFERIORITY|A non-inferiority margin of 3 points was used.|LS Mean|-8.5|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-10.1|-7.0|||Heterogeneous mixed model analysis||Mean difference was calculated as Arm 2 (senofilcon A) minus Arm 2 (subjects' own contact lens)|||-7.0|-10.1|
71886898|NCT01405053|143294201|SUPERIORITY||LS Mean difference|2.601|STANDARD_ERROR_OF_MEAN|6.558||0.6928|TWO_SIDED|95.0|-10.5|15.7|||ANCOVA|||The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.||15.7|-10.5|0.6928
71828111|NCT02459899|143160734|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.136||0.006|TWO_SIDED|95.0|-0.65|-0.11||Threshold for significance \< 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.11|-0.65|0.006
71828112|NCT04470193|143160745|SUPERIORITY|We approached 62 subjects to get a sample size of 50 participants, allowing up to 16% attrition, to estimate the proportions of patients satisfying dropout of 0.13 to within margins of error (half-widths of 90% Cis). The 50 evaluable subjects were used to estimate the SD of QoL, with a margin of error of ∼20%. The sample size also allowed us to provide provisional estimates of the effect size for the QoL outcome to within a margin of error of ±7.1 points, assuming a true SD of 15 points.|||||>|0.05|||||||generalized estimating equation model|||We used a generalized estimating equation model for repeated assessments, with a common unstructured residual covariance matrix to account for correlation in repeated measurements in the same patient, to compare QoL total score at baseline, 1 month, and 3 months between the groups. We hypothesized that MyChildCMC users would have better outcomes for the child (higher QoL, fewer ED and/or hospital use and hospital days) and parent (higher satisfaction with child's care).||||>0.05
71886899|NCT02642094|143294215|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.0020
71714610|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|0.74|||||TWO_SIDED|90.0|0.3|1.84||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.84|0.30|
71714611|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|1.78|||||TWO_SIDED|90.0|0.72|4.37||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.37|0.72|
71714612|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED|90.0|0.5|2.92||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.92|0.50|
71714613|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|90.0|0.89|5.55||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.55|0.89|
71714614|NCT01405196|142945264|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.4|2.46||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.46|0.40|
71714615|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|90.0|0.53|3.35||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.35|0.53|
71714616|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|90.0|0.41|2.65||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.65|0.41|
71714617|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.33|1.96||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||1.96|0.33|
71714618|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|90.0|0.39|2.23||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.23|0.39|
71714619|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|90.0|0.42|2.45||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.45|0.42|
71714620|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|1.31|||||TWO_SIDED|90.0|0.55|3.1||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||3.10|0.55|
71714621|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|90.0|0.95|5.88||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.88|0.95|
71714622|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|90.0|0.74|4.46||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.46|0.74|
71828113|NCT04470193|143160746|SUPERIORITY||Risk Ratio (RR)|1.05||||0.882|TWO_SIDED|95.0|0.58|1.88|||Mixed Models Analysis|||||1.88|0.58|0.882
71886900|NCT02642094|143294216|SUPERIORITY|||||||0.0137|||||||t-test, 2 sided|||||||0.0137
71886901|NCT02642094|143294217|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71714623|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|90.0|1.1|7.12||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.12|1.10|
71714624|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|90.0|0.66|4.21||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.21|0.66|
71714625|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|2.95|||||TWO_SIDED|90.0|1.18|7.41||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||7.41|1.18|
71886902|NCT02642094|143294218|SUPERIORITY|||||||0.0072|||||||t-test, 2 sided|||||||0.0072
71886903|NCT02642094|143294219|SUPERIORITY|||||||0.3093|||||||t-test, 2 sided|||||||0.3093
71714626|NCT01405196|142945265|SUPERIORITY||Odds Ratio (OR)|2.03|||||TWO_SIDED|90.0|0.82|5.06||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||5.06|0.82|
71714627|NCT01405196|142945266|SUPERIORITY||Odds Ratio (OR)|1.59||||0.205|TWO_SIDED|90.0|0.63|4.02||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||4.02|0.63|0.205
71714628|NCT01405196|142945266|SUPERIORITY||Odds Ratio (OR)|0.84||||0.625|TWO_SIDED|90.0|0.34|2.08||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||\>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||2.08|0.34|0.625
71714629|NCT01405196|142945266|SUPERIORITY||Odds Ratio (OR)|2.81||||0.198|TWO_SIDED|90.0|0.38|20.65||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||20.65|0.38|0.198
71714630|NCT01405196|142945266|SUPERIORITY||Odds Ratio (OR)|2.88||||0.192|TWO_SIDED|90.0|0.39|21.3||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.||21.30|0.39|0.192
71714631|NCT01405196|142945278|SUPERIORITY||LS mean difference|-5.41|||||TWO_SIDED|90.0|-12.3|1.49||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||1.49|-12.30|
71714632|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-1.39|||||TWO_SIDED|90.0|-8.21|5.42||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||5.42|-8.21|
71714633|NCT01405196|142945278|SUPERIORITY||LS Mean difference|1.3|||||TWO_SIDED|90.0|-5.71|8.32||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.32|-5.71|
71714634|NCT01405196|142945278|SUPERIORITY||LS Mean difference|4.67|||||TWO_SIDED|90.0|-2.22|11.57||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||11.57|-2.22|
71714635|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-3.98|||||TWO_SIDED|90.0|-11.04|3.07||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||3.07|-11.04|
71714636|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-2.89|||||TWO_SIDED|90.0|-9.87|4.1||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.10|-9.87|
71714637|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-6.21|||||TWO_SIDED|90.0|-13.37|0.94||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||0.94|-13.37|
71714638|NCT01405196|142945278|SUPERIORITY||LS Mean difference|1.98|||||TWO_SIDED|90.0|-5.17|9.13||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.13|-5.17|
71714639|NCT01405196|142945278|SUPERIORITY||LS Mean difference|2.07|||||TWO_SIDED|90.0|-4.7|8.84||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||8.84|-4.70|
71714640|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-2.81|||||TWO_SIDED|90.0|-9.62|4.0||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.00|-9.62|
71714641|NCT01405196|142945278|SUPERIORITY||LS Mean difference|3.97|||||TWO_SIDED|90.0|-2.95|10.9||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||10.90|-2.95|
71714642|NCT01405196|142945278|SUPERIORITY||LS Mean difference|2.56|||||TWO_SIDED|90.0|-4.29|9.4||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.40|-4.29|
71714643|NCT01405196|142945278|SUPERIORITY||LS Mean difference|3.14|||||TWO_SIDED|90.0|-3.67|9.94||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.94|-3.67|
71714644|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-4.94|||||TWO_SIDED|90.0|-11.91|2.03||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||2.03|-11.91|
71714645|NCT01405196|142945278|SUPERIORITY||LS Mean difference|-2.64|||||TWO_SIDED|90.0|-9.61|4.32||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||4.32|-9.61|
71828114|NCT04470193|143160747|SUPERIORITY||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.62|||Mixed Models Analysis|||||0.62|0.39|<0.001
71828115|NCT04470193|143160748|SUPERIORITY||Risk Ratio (RR)|1.11||||0.035|TWO_SIDED|95.0|1.01|1.22|||Mixed Models Analysis|||||1.22|1.01|0.035
71828116|NCT03612804|143160762|SUPERIORITY||Odds Ratio (OR)|1.05||||0.83|TWO_SIDED|95.0|0.67|1.64||P-value not adjusted for multiple comparisons. A priori threshold for statistical significance was 0.05.|Regression, Logistic|Logistic regression model with random intercept for provider and main effect term for study site.|Proactive care arm represents numerator of odds ratio, unstructured care arm represents denominator of odds ratio.|||1.64|0.67|0.83
71828117|NCT03105128|143160770|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
71828118|NCT03105128|143160770|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
71714646|NCT01405196|142945278|SUPERIORITY||LS Mean difference|2.66|||||TWO_SIDED|90.0|-4.48|9.8||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.||9.80|-4.48|
71714647|NCT01405196|142945279|SUPERIORITY||LS mean difference|3.63||||||90.0|-2.56|9.83||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||9.83|-2.56|
71828119|NCT03105128|143160771|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
71828120|NCT03105128|143160771|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
71828121|NCT03105128|143160772|SUPERIORITY||Adjusted Risk Difference|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
71828122|NCT03105128|143160772|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
71828123|NCT03105128|143160773|SUPERIORITY||Adjusted Risk Difference|28.3|||<|0.001|TWO_SIDED|95.0|21.2|35.4|||Cochran-Mantel-Haenszel|||||35.4|21.2|<0.001
71828124|NCT03105128|143160773|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.6|27.1|||Cochran-Mantel-Haenszel|||||27.1|13.6|<0.001
71886904|NCT02175680|143294224|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum|The time to Virologic Failure for the subjects treated with PRO 140 monotherapy was compared to historical data.|||The median time to Virologic Failure for historical controls was 29 days.|||<0.0001
71714648|NCT01405196|142945279|SUPERIORITY||LS mean difference|-2.02||||||90.0|-8.21|4.18||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||4.18|-8.21|
71714649|NCT01405196|142945279|SUPERIORITY||LS mean difference|2.62|||||TWO_SIDED|90.0|-3.57|8.82||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.82|-3.57|
71714650|NCT01405196|142945279|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-4.51|7.88||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.88|-4.51|
71767328|NCT04575597|143036299|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.37|1.81||||||||1.81|0.37|
71828125|NCT03105128|143160774|SUPERIORITY||Risk Difference (RD)|21.9|||<|0.001|TWO_SIDED|95.0|13.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|13.8|<0.001
71828126|NCT03105128|143160774|SUPERIORITY||Adjusted Risk Difference|18.8|||<|0.001|TWO_SIDED|95.0|10.8|26.8|||Cochran-Mantel-Haenszel|||||26.8|10.8|<0.001
71828127|NCT03105128|143160775|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
71828128|NCT03105128|143160775|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
71828129|NCT03105128|143160776|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
71828130|NCT03105128|143160776|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
71828131|NCT03105128|143160777|SUPERIORITY||Adjusted Risk Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Cochran-Mantel-Haenszel|||||7.2|3.2|<0.001
71886905|NCT03979274|143294247|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|98.53|||||TWO_SIDED|90.0|94.55|102.68||||||||102.68|94.55|
71828132|NCT03105128|143160777|SUPERIORITY||Adjusted Risk Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Cochran-Mantel-Haenszel|||||6.1|2.1|<0.001
71828133|NCT03105128|143160778|SUPERIORITY||Adjusted Risk Difference|7.6||||0.015|TWO_SIDED|95.0|1.5|13.7|||Cochran-Mantel-Haenszel|||||13.7|1.5|0.015
71828134|NCT03105128|143160778|SUPERIORITY||Adjusted Risk Difference|8.4||||0.007|TWO_SIDED|95.0|2.3|14.6|||Cochran-Mantel-Haenszel|||||14.6|2.3|0.007
71828135|NCT03105128|143160779|SUPERIORITY||Adjusted Risk Difference|24.5|||<|0.001|TWO_SIDED|95.0|18.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|18.5|<0.001
71828136|NCT03105128|143160779|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|11.8|22.9|||Cochran-Mantel-Haenszel|||||22.9|11.8|<0.001
71828137|NCT03105128|143160780|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.001|TWO_SIDED|95.0|15.7|32.7|||Cochran-Mantel-Haenszel|||||32.7|15.7|<0.001
71828138|NCT03105128|143160780|SUPERIORITY||Adjusted Risk Difference|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1|||Cochran-Mantel-Haenszel|||||32.1|15.1|<0.001
71828139|NCT03105128|143160781|SUPERIORITY||Adjusted Risk Difference|21.2|||<|0.001|TWO_SIDED|95.0|12.4|30.0|||Cochran-Mantel-Haenszel|||||30.0|12.4|<0.001
71828140|NCT03105128|143160781|SUPERIORITY||Adjusted Risk Difference|19.0|||<|0.001|TWO_SIDED|95.0|10.1|27.8|||Cochran-Mantel-Haenszel|||||27.8|10.1|<0.001
71828141|NCT03105128|143160782|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
71828142|NCT03105128|143160782|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
71828143|NCT03105128|143160783|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
71828144|NCT03105128|143160783|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
71828145|NCT03105128|143160784|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
71886906|NCT03979274|143294248|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|97.59|||||TWO_SIDED|90.0|91.34|104.26||||||||104.26|91.34|
71828146|NCT03105128|143160784|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
71828147|NCT03105128|143160785|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
71828148|NCT03105128|143160785|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
71714651|NCT01405196|142945279|SUPERIORITY||LS mean difference|4.59|||||TWO_SIDED|90.0|-1.61|10.79||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.79|-1.61|
71714652|NCT01405196|142945279|SUPERIORITY||LS mean difference|3.95||||||90.0|-2.24|10.15||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||10.15|-2.24|
71714653|NCT01405196|142945279|SUPERIORITY||LS mean difference|1.92||||||90.0|-4.17|8.01||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||8.01|-4.17|
71714654|NCT01405196|142945279|SUPERIORITY||LS mean difference|-4.2||||||90.0|-10.25|1.85||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||1.85|-10.25|
71714655|NCT01405196|142945279|SUPERIORITY||LS mean difference|1.5|||||TWO_SIDED|90.0|-4.56|7.55||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||7.55|-4.56|
71714656|NCT01405196|142945279|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|90.0|-5.96|6.15||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||6.15|-5.96|
71714657|NCT01405196|142945279|SUPERIORITY||LS mean difference|-0.34|||||TWO_SIDED|90.0|-6.39|5.71||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||5.71|-6.39|
71714658|NCT01405196|142945279|SUPERIORITY||LS mean difference|-2.34|||||TWO_SIDED|90.0|-8.39|3.71||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.||3.71|-8.39|
71828149|NCT03105128|143160786|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
71828150|NCT03105128|143160786|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
71828151|NCT03105128|143160787|SUPERIORITY||Risk Difference (RD)|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Chi-squared|||||-3.5|-13.9|<0.001
71828152|NCT03105128|143160787|SUPERIORITY||Risk Difference (RD)|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Chi-squared|||||-5.2|-15.2|<0.001
71714659|NCT01405196|142945281|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
71714660|NCT01405196|142945281|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
71714661|NCT01405196|142945281|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
71714662|NCT01405196|142945281|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
71714663|NCT01405196|142945281|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
71714664|NCT01405196|142945281|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
71714665|NCT01405196|142945281|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
71714666|NCT01405196|142945281|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
71714667|NCT01405196|142945281|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
71828153|NCT03105128|143160788|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Chi-squared|||||39.7|-28.6|1.00
71828154|NCT03105128|143160788|SUPERIORITY||Risk Difference (RD)|6.9||||1|TWO_SIDED|25.0|-25.7|39.6|||Chi-squared|||||39.6|-25.7|1.000
71828155|NCT03105128|143160789|SUPERIORITY||Adjusted Risk Difference|20.7|||<|0.001|TWO_SIDED|95.0|12.4|29.0|||Cochran-Mantel-Haenszel|||||29.0|12.4|<0.001
71828156|NCT03105128|143160789|SUPERIORITY||Adjusted Risk Difference|16.7|||<|0.001|TWO_SIDED|95.0|8.5|24.9|||Cochran-Mantel-Haenszel|||||24.9|8.5|<0.001
71828157|NCT03105128|143160790|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|7.2|23.7|||Cochran-Mantel-Haenszel|||||23.7|7.2|<0.001
71828158|NCT03105128|143160790|SUPERIORITY||Adjusted Risk Difference|11.2||||0.007|TWO_SIDED|95.0|3.1|19.2|||Cochran-Mantel-Haenszel|||||19.2|3.1|0.007
71828159|NCT03105128|143160791|SUPERIORITY||Adjusted Risk Difference|11.5|||<|0.001|TWO_SIDED|95.0|5.4|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.4|<0.001
71714668|NCT01405196|142945281|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
71828160|NCT03105128|143160791|SUPERIORITY||Adjusted Risk Difference|11.7|||<|0.001|TWO_SIDED|95.0|5.7|17.8|||Cochran-Mantel-Haenszel|||||17.8|5.7|<0.001
71828161|NCT03105128|143160792|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|14.2|31.9|||Cochran-Mantel-Haenszel|||||31.9|14.2|<0.001
71828162|NCT03105128|143160792|SUPERIORITY||Adjusted Risk Difference|27.7|||<|0.001|TWO_SIDED|95.0|19.0|36.4|||Cochran-Mantel-Haenszel|||||36.4|19.0|<0.001
71828163|NCT03105128|143160793|SUPERIORITY||LS Mean Difference|5.2|||<|0.001|TWO_SIDED|95.0|3.2|7.2|||Mixed-Effect Model Repeat Measurement|||||7.2|3.2|<0.001
71828164|NCT03105128|143160793|SUPERIORITY||LS Mean Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||Mixed-Effect Model Repeat Measurement|||||6.1|2.1|<0.001
71828165|NCT03105128|143160794|SUPERIORITY||LS Mean Difference|20.7|||<|0.001|TWO_SIDED|95.0|14.3|27.1|||Mixed-Effect Model Repeat Measurement|||||27.1|14.3|<0.001
71828166|NCT03105128|143160794|SUPERIORITY||LS Mean Difference|19.4|||<|0.001|TWO_SIDED|95.0|13.1|25.8|||Mixed-Effect Model Repeat Measurement|||||25.8|13.1|<0.001
71828167|NCT03105128|143160795|SUPERIORITY||Adjusted Risk Difference|23.2|||<|0.001|TWO_SIDED|95.0|16.8|29.6|||Cochran-Mantel-Haenszel|||||29.6|16.8|<0.001
71828168|NCT03105128|143160795|SUPERIORITY||Adjusted Risk Difference|15.2|||<|0.001|TWO_SIDED|95.0|9.3|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.3|<0.001
71828169|NCT03105128|143160796|SUPERIORITY||Adjusted Risk Difference|15.1|||<|0.001|TWO_SIDED|95.0|9.0|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.0|<0.001
71828170|NCT03105128|143160796|SUPERIORITY||Adjusted Risk Difference|15.4|||<|0.001|TWO_SIDED|95.0|9.4|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.4|<0.001
71828171|NCT03105128|143160797|SUPERIORITY||Adjusted Risk Difference|14.9||||0.001|TWO_SIDED|95.0|6.2|23.5|||Cochran-Mantel-Haenszel|||||23.5|6.2|0.001
71828172|NCT03105128|143160797|SUPERIORITY||Adjusted Risk Difference|11.8||||0.007|TWO_SIDED|95.0|3.2|20.3|||Cochran-Mantel-Haenszel|||||20.3|3.2|0.007
71828173|NCT03105128|143160798|SUPERIORITY||Adjusted Risk Difference|13.7|||<|0.001|TWO_SIDED|95.0|7.9|19.5|||Cochran-Mantel-Haenszel|||||19.5|7.9|<0.001
71828174|NCT03105128|143160798|SUPERIORITY||Adjusted Risk Difference|9.1||||0.001|TWO_SIDED|95.0|3.7|14.5|||Cochran-Mantel-Haenszel|||||14.5|3.7|0.001
71828175|NCT03105128|143160799|SUPERIORITY||Adjusted Risk Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|12.2|<0.001
71828176|NCT03105128|143160799|SUPERIORITY||Adjusted Risk Difference|21.6|||<|0.001|TWO_SIDED|95.0|12.8|30.4|||Cochran-Mantel-Haenszel|||||30.4|12.8|<0.001
71828177|NCT03105128|143160800|SUPERIORITY||Adjusted Risk Difference|14.6||||0.022|TWO_SIDED|95.0|2.1|27.0|||Cochran-Mantel-Haenszel|||||27.0|2.1|0.022
71714669|NCT01405196|142945281|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
71714670|NCT01405196|142945281|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
71714671|NCT01405196|142945281|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
71828178|NCT03105128|143160800|SUPERIORITY||Adjusted Risk Difference|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.3|||Cochran-Mantel-Haenszel|||||36.3|11.1|<0.001
71828179|NCT03105128|143160801|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-13.9|-3.5|||Mixed-Effect Model Repeat Measurement|||||-3.5|-13.9|<0.001
71828180|NCT03105128|143160801|SUPERIORITY||LS Mean Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.2|-5.2|||Mixed-Effect Model Repeat Measurement|||||-5.2|-15.2|<0.001
71828181|NCT03105128|143160802|SUPERIORITY||LS Mean Difference|5.6||||1|TWO_SIDED|95.0|-28.6|39.7|||Mixed-Effect Model Repeat Measurement|||||39.7|-28.6|1.000
71828182|NCT03105128|143160802|SUPERIORITY||LS Mean Difference|6.9||||1|TWO_SIDED|95.0|-25.7|39.6|||Mixed-Effect Model Repeat Measurement|||||39.6|-25.7|1.000
71828183|NCT03105128|143160803|SUPERIORITY||LS Mean Difference|-9.586||||0.024|TWO_SIDED|95.0|-17.89|-1.282|||Mixed-Effect Model Repeat Measurement|||||-1.282|-17.890|0.024
71828184|NCT03105128|143160803|SUPERIORITY||LS Mean Difference|-12.141||||0.004|TWO_SIDED|95.0|-20.39|-3.892|||Mixed-Effect Model Repeat Measurement|||||-3.892|-20.390|0.004
71828185|NCT03105128|143160804|SUPERIORITY||LS Mean Difference|2.913|||<|0.001|TWO_SIDED|95.0|1.512|4.313|||Mixed-Effect Model Repeat Measurement|||||4.313|1.512|<0.001
71828186|NCT03105128|143160804|SUPERIORITY||LS Mean Difference|3.275|||<|0.001|TWO_SIDED|95.0|1.877|4.672|||Mixed-Effect Model Repeat Measurement|||||4.672|1.877|<0.001
71828187|NCT00361283|143160828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-111.0|STANDARD_ERROR_OF_MEAN|76.7||0.15|TWO_SIDED|95.0|-264.0|42.0||No confounders were controlled for as each person is his/her own control.|t-test, 2 sided|||The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.||42|-264|0.15
71828188|NCT00038103|143160829|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|49.0||||||95.0|34.4|63.7|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||63.7|34.4|
71828189|NCT00038103|143160829|SUPERIORITY_OR_OTHER||Clinical Benefit Rate|47.1||||||95.0|32.9|61.5|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.|||61.5|32.9|
71828190|NCT00038103|143160830|SUPERIORITY_OR_OTHER||Objective Response Rate|22.4||||||95.0|11.8|36.6|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||36.6|11.8|
71767329|NCT04575597|143036299|OTHER|Odds ratio was based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
71767330|NCT04575597|143036300|OTHER|Difference in rates % and associated CIs were based on the Miettinen \& Nurminen method stratified by randomization strata. Unknown survival status at Day 29 was treated as failure.|Difference in Rates %|-3.0|||||TWO_SIDED|95.0|-5.9|-0.1||||||||-0.1|-5.9|
71767331|NCT01976988|143036325|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
71767332|NCT01976988|143036326|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||0.36
71767333|NCT01976988|143036327|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
71767334|NCT01976988|143036328|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1
71767335|NCT01976988|143036329|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71828191|NCT00038103|143160830|SUPERIORITY_OR_OTHER||Objective Response Rate|23.5||||||95.0|12.8|37.5|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.|||37.5|12.8|
71828192|NCT05147233|143160873|SUPERIORITY||Difference in Percentages|33.2|||<|0.0001|TWO_SIDED|95.0|21.5|44.9|||Wald test|||||44.9|21.5|<0.0001
71828193|NCT05147233|143160874|SUPERIORITY||Difference in Percentages|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Wald test|||||35.3|11.7|<0.0001
71828194|NCT00726596|143160897|SUPERIORITY|||||||0.6789|||||||t-test, 1 sided|||||||.6789
71828195|NCT02962674|143160915|SUPERIORITY|||||||0.004|||||||t-test, 1 sided|||"The null and alternative hypotheses associated with this objective was written as:~H0: μ ΔIPSS ≤ 6.5 points HA: μ ΔIPSS \> 6.5 points where μ ΔIPSS was the true underlying value of mean ΔIPSS following a treatment at the 3-month follow-up visit and 6.5 points was an objective performance goal (OPG). The objective was met at a given time point by rejecting the null hypothesis in a one-sided t-test at the 5% significance level."||||0.004
71828196|NCT01124188|143160940|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.63|1.8||||||||1.80|0.63|
71828197|NCT01124188|143160941|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mixed Models Analysis|||||||.49
71828198|NCT01124188|143160942|SUPERIORITY_OR_OTHER|||||||0.88|||||||Mixed Models Analysis|||||||0.88
71828199|NCT01499134|143160962|SUPERIORITY_OR_OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71828200|NCT01499134|143160963|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
71767336|NCT01976988|143036330|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
71767337|NCT03207438|143036331|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
71767338|NCT03207438|143036331|SUPERIORITY||Hazard Ratio (HR)|1.15|STANDARD_ERROR_OF_MEAN|0.1||0.18|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.18
71828201|NCT01499134|143160964|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||This p-value is correct, confirmed with report from statistician.|Wilcoxon (Mann-Whitney)|||||||1.000
71828202|NCT01499134|143160965|SUPERIORITY_OR_OTHER|||||||0.363|||||||Wilcoxon (Mann-Whitney)|||||||0.363
71828203|NCT01499134|143160966|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
71767339|NCT03207438|143036331|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
71767340|NCT03207438|143036331|SUPERIORITY||Hazard Ratio (HR)|1.17|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.14
71767341|NCT03207438|143036332|SUPERIORITY||Hazard Ratio (HR)|1.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|||Main effect of quetiapine vs. placebo||||<.001
71767342|NCT03207438|143036332|SUPERIORITY||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Regression, Cox|||Interaction - treatment condition x melancholia||||.17
71767343|NCT03207438|143036332|SUPERIORITY||Hazard Ratio (HR)|1.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo||||<.001
71767344|NCT03207438|143036332|SUPERIORITY||Hazard Ratio (HR)|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.13|TWO_SIDED||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia||||.13
71828204|NCT01499134|143160967|SUPERIORITY_OR_OTHER|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||||||0.476
71828205|NCT01499134|143160968|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.170
71828206|NCT01499134|143160969|SUPERIORITY_OR_OTHER|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||||||0.595
71828207|NCT00955825|143160970|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.126||||0.0003||95.0|-0.194|-0.058|||ANCOVA||Relative LS Means difference (%) = - 28.24|||-0.058|-0.194|0.0003
71828208|NCT01198275|143160972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.05|TWO_SIDED|95.0|0.292|0.666|||Kaplan Meyer analysis|The time to first AF recurrence was analyzed with the Kaplan-Meier method and compared with the log-rank test.|Hazard ratios between n-3 PUFA and Placebo together with confidence intervals were estimated using the Cox proportional regression model.|Give a relapse rate ranging from 40% to 60% on ACE-I/ARB and amiodarone therapy, considering the high risk of relapses in our study population we conservatively assumed a 50% relapse rate. We calculated that a total of 180 patients would yield 80% power to detect a clinically relevant difference of about 20% in AF recurrence with the addition of n-3 PUFAs at a log-rank test, with a significance level of 0.05.||0.666|0.292|< 0.05
71828209|NCT01227278|143160983|SUPERIORITY_OR_OTHER||Rate ratio|1.03||||0.941|TWO_SIDED|95.0|0.67|1.58|||Van Elteren Test|Day 1 to 393: Van Elteren test was used to compare the two arms.|95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.|||1.58|0.67|0.941
71828210|NCT04035668|143160993|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.002|TWO_SIDED|95.0|-4.71|-1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|||-1.01|-4.71|0.002
71828211|NCT04035668|143160993|OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.24|1.25|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|||1.25|-3.24|
71714672|NCT01405196|142945281|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
71714673|NCT01405196|142945281|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
71714674|NCT01405196|142945281|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
71714675|NCT01405196|142945281|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
71714676|NCT01405196|142945281|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
71714677|NCT01405196|142945281|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
71714678|NCT01405196|142945281|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
71714679|NCT01405196|142945281|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
71714680|NCT01405196|142945281|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
71714681|NCT01405196|142945281|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
71714682|NCT01405196|142945281|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
71714683|NCT01405196|142945282|SUPERIORITY||LS mean difference|0.47||||||90.0|-6.33|7.27||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.27|-6.33|
71714684|NCT01405196|142945282|SUPERIORITY||LS mean difference|3.92||||||90.0|-2.88|10.72||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.72|-2.88|
71714685|NCT01405196|142945282|SUPERIORITY||LS mean difference|3.55|||||TWO_SIDED|90.0|-3.25|10.36||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.36|-3.25|
71714686|NCT01405196|142945282|SUPERIORITY||LS mean difference|7.85|||||TWO_SIDED|90.0|1.05|14.66||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||14.66|1.05|
71714687|NCT01405196|142945282|SUPERIORITY||LS mean difference|7.12|||||TWO_SIDED|90.0|0.32|13.92||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||13.92|0.32|
71714688|NCT01405196|142945282|SUPERIORITY||LS mean difference|4.33|||||TWO_SIDED|90.0|-2.47|11.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||11.13|-2.47|
71714689|NCT01405196|142945282|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-5.4|8.05||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.05|-5.40|
71714690|NCT01405196|142945282|SUPERIORITY||LS mean difference|3.93|||||TWO_SIDED|90.0|-2.75|10.62||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.62|-2.75|
71714691|NCT01405196|142945282|SUPERIORITY||LS mean difference|-0.78|||||TWO_SIDED|90.0|-7.47|5.91||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.91|-7.47|
71714692|NCT01405196|142945282|SUPERIORITY||LS mean difference|3.67||||||90.0|-3.02|10.35||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||10.35|-3.02|
71714693|NCT01405196|142945282|SUPERIORITY||LS mean difference|2.99|||||TWO_SIDED|90.0|-3.7|9.68||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||9.68|-3.70|
71714694|NCT01405196|142945282|SUPERIORITY||LS mean difference|1.44|||||TWO_SIDED|90.0|-5.24|8.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||8.13|-5.24|
71714695|NCT01405196|142945283|SUPERIORITY||LS mean difference|0.53|||||TWO_SIDED|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.59|-2.53|
71714696|NCT01405196|142945283|SUPERIORITY||LS mean difference|-0.48|||||TWO_SIDED|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.58|-3.54|
71714697|NCT01405196|142945283|SUPERIORITY||LS mean difference|1.28|||||TWO_SIDED|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.34|-1.78|
71714698|NCT01405196|142945283|SUPERIORITY||LS mean difference|1.78|||||TWO_SIDED|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.84|-1.28|
71714699|NCT01405196|142945283|SUPERIORITY||LS mean difference|1.2|||||TWO_SIDED|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-1.86|
71714700|NCT01405196|142945283|SUPERIORITY||LS mean difference|0.09|||||TWO_SIDED|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.15|-2.98|
71714701|NCT01405196|142945283|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.03|-3.03|
71714702|NCT01405196|142945283|SUPERIORITY||LS mean difference|-0.09|||||TWO_SIDED|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.92|-3.09|
71714703|NCT01405196|142945283|SUPERIORITY||LS mean difference|-0.02|||||TWO_SIDED|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.99|-3.03|
71714704|NCT01405196|142945283|SUPERIORITY||LS mean difference|-0.16|||||TWO_SIDED|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.85|-3.17|
71767345|NCT03207438|143036333|SUPERIORITY|||||||0.33|||||||Fisher's exact test|||Day 4 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|An exact OR could not be estimated by R; the 95% confidence interval was 0.31 to infinity, p = .33.|||.33
71828212|NCT04035668|143160994|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.065|TWO_SIDED|95.0|-2.29|0.3||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.30|-2.29|0.065
71828213|NCT04035668|143160994|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.01|TWO_SIDED|95.0|-3.24|-0.29||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||-0.29|-3.24|0.010
71828214|NCT04035668|143160994|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.289|TWO_SIDED|95.0|-2.17|1.22||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||1.22|-2.17|0.289
71828215|NCT04035668|143160994|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.093|TWO_SIDED|95.0|-2.97|0.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.59|-2.97|0.093
71828216|NCT04035668|143160994|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.094|TWO_SIDED|95.0|-2.84|0.57||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.57|-2.84|0.094
71828217|NCT04035668|143160994|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.012|TWO_SIDED|95.0|-3.71|-0.28||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|-0.28|-3.71|0.012
71661043|NCT03433755|142835767|SUPERIORITY||Treatment difference|-51.21|STANDARD_ERROR_OF_MEAN|3.45|<|0.0001|TWO_SIDED|95.0|-58.06|-44.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-44.37|-58.06|< 0.0001
71828218|NCT04035668|143160994|OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-2.1|0.84|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.84|-2.10|
71828219|NCT04035668|143160994|OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-1.75|1.69|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||1.69|-1.75|
71661044|NCT03433755|142835768|SUPERIORITY||Treatment difference|-42.74|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-48.06|-37.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.41|-48.06|< 0.0001
71661045|NCT03433755|142835768|SUPERIORITY||Treatment difference|-44.3|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-49.02|-39.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-39.58|-49.02|< 0.0001
71661046|NCT03433755|142835769|SUPERIORITY||Treatment difference|-43.05|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001|TWO_SIDED|95.0|-49.09|-37.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-37.00|-49.09|< 0.0001
71661047|NCT03433755|142835769|SUPERIORITY||Treatment difference|-40.42|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-45.98|-34.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-34.87|-45.98|< 0.0001
71661048|NCT03433755|142835770|SUPERIORITY||Treatment difference|87.2|||<|0.0001|TWO_SIDED|95.0|72.6|92.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||92.8|72.6|< 0.0001
71661049|NCT03433755|142835770|SUPERIORITY||Treatment difference|91.5|||<|0.0001|TWO_SIDED|95.0|76.9|96.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||96.1|76.9|< 0.0001
71661050|NCT03433755|142835771|SUPERIORITY||Treatment difference|90.6|||<|0.0001|TWO_SIDED|95.0|76.6|95.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||95.6|76.6|< 0.0001
71661051|NCT03433755|142835771|SUPERIORITY||Treatment difference|85.7|||<|0.0001|TWO_SIDED|95.0|68.2|91.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||91.9|68.2|< 0.0001
71661052|NCT03433755|142835772|SUPERIORITY||Treatment difference|87.0|||<|0.0001|TWO_SIDED|95.0|73.3|93.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||93.0|73.3|< 0.0001
71661053|NCT03433755|142835772|SUPERIORITY||Treatment difference|88.7|||<|0.0001|TWO_SIDED|95.0|73.5|94.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||94.0|73.5|< 0.0001
71661054|NCT03433755|142835773|SUPERIORITY||Treatment difference|82.8|||<|0.0001|TWO_SIDED|95.0|67.8|90.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||90.1|67.8|< 0.0001
71828220|NCT04035668|143160994|OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.83|2.21|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||2.21|-1.83|
71714705|NCT01405196|142945283|SUPERIORITY||LS mean difference|-1.58|||||TWO_SIDED|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||1.43|-4.58|
71714706|NCT01405196|142945283|SUPERIORITY||LS mean difference|-0.71|||||TWO_SIDED|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||2.30|-3.72|
71714707|NCT01405196|142945283|SUPERIORITY||LS mean difference|2.67|||||TWO_SIDED|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.20|0.14|
71714708|NCT01405196|142945283|SUPERIORITY||LS mean difference|3.36|||||TWO_SIDED|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.89|0.84|
71714709|NCT01405196|142945283|SUPERIORITY||LS mean difference|3.23|||||TWO_SIDED|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.76|0.70|
71767346|NCT03207438|143036333|SUPERIORITY||Odds Ratio (OR)|1.3||||0.44|TWO_SIDED||||||Fisher's exact test||The exact limits of 95% confidence interval could not be estimated, it was reported as 0.40 to infinity.|Week 1 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup||||.44
71767347|NCT03207438|143036333|SUPERIORITY||Chi-squared|0.38||||0.73|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.73
71828221|NCT04035668|143160994|OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.2|1.01|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||1.01|-3.20|
71828222|NCT04035668|143160994|OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|95.0|-3.5|0.6|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.60|-3.50|
71828223|NCT04035668|143160994|OTHER||Mean Difference (Final Values)|-1.14|||||TWO_SIDED|95.0|-3.22|0.95|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.95|-3.22|
71828224|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.46|TWO_SIDED|95.0|-0.69|0.62||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.62|-0.69|0.460
71714710|NCT01405196|142945283|SUPERIORITY||LS mean difference|3.77|||||TWO_SIDED|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.30|1.24|
71828225|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.418|TWO_SIDED|95.0|-0.82|0.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||0.66|-0.82|0.418
71714711|NCT01405196|142945283|SUPERIORITY||LS mean difference|3.1|||||TWO_SIDED|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.63|0.57|
71767348|NCT03207438|143036333|SUPERIORITY||Chi-squared|1.5||||0.11|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.11
71767349|NCT03207438|143036333|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||The actual estimated Chi-squared statistic was 6.35(10\^-31)|Week 6 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup||||.50
71714712|NCT01405196|142945283|SUPERIORITY||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.56|0.50|
71714713|NCT01405196|142945283|SUPERIORITY||LS mean difference|1.96|||||TWO_SIDED|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.46|-0.53|
71714714|NCT01405196|142945283|SUPERIORITY||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.17|0.20|
71714715|NCT01405196|142945283|SUPERIORITY||LS mean difference|1.84|||||TWO_SIDED|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.32|-0.65|
71714716|NCT01405196|142945283|SUPERIORITY||LS mean difference|2.01|||||TWO_SIDED|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.50|-0.47|
71714717|NCT01405196|142945283|SUPERIORITY||LS mean difference|2.34|||||TWO_SIDED|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.82|-0.15|
71714718|NCT01405196|142945283|SUPERIORITY||LS mean difference|2.59|||||TWO_SIDED|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.08|0.11|
71714719|NCT01405196|142945285|SUPERIORITY||LS mean difference|2.08|||||TWO_SIDED|90.0|-1.26|5.42||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the Least Square (LS) mean difference from that model.||5.42|-1.26|
71714720|NCT01405196|142945285|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.38|5.29||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.38|
71714721|NCT01405196|142945285|SUPERIORITY||LS mean difference|2.81|||||TWO_SIDED|90.0|-0.53|6.15||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.15|-0.53|
71767350|NCT03207438|143036334|SUPERIORITY||Chi-squared|0.001||||0.5|TWO_SIDED||||||Chi-squared, Corrected||Estimated chi-squared statistic was 1.88(10\^-29).|Day 4 - chi-squared test comparing response rates between groups.||||.5
71767351|NCT03207438|143036334|SUPERIORITY||Chi-squared|3.3||||0.03|TWO_SIDED||||||Chi-squared, Corrected|||Week 1 - chi-squared test comparing response rates between groups.||||.03
71828226|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.466|TWO_SIDED|95.0|-0.76|0.7||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||0.70|-0.76|0.466
71828227|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.56|TWO_SIDED|95.0|-0.67|0.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||0.79|-0.67|0.560
71828228|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.616|TWO_SIDED|95.0|-0.73|0.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||0.99|-0.73|0.616
71828229|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.581|TWO_SIDED|95.0|-0.81|0.99||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|0.99|-0.81|0.581
71714722|NCT01405196|142945285|SUPERIORITY||LS mean difference|3.88|||||TWO_SIDED|90.0|0.54|7.22||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||7.22|0.54|
71714723|NCT01405196|142945285|SUPERIORITY||LS mean difference|1.95|||||TWO_SIDED|90.0|-1.39|5.29||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.29|-1.39|
71714724|NCT01405196|142945285|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.65|5.03||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||5.03|-1.65|
71714725|NCT01405196|142945285|SUPERIORITY||LS mean difference|1.69|||||TWO_SIDED|90.0|-1.61|4.99||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.99|-1.61|
71714726|NCT01405196|142945285|SUPERIORITY||LS mean difference|0.97|||||TWO_SIDED|90.0|-2.31|4.26||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.26|-2.31|
71714727|NCT01405196|142945285|SUPERIORITY||LS mean difference|1.33|||||TWO_SIDED|90.0|-1.96|4.61||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.61|-1.96|
71714728|NCT01405196|142945285|SUPERIORITY||LS mean difference|3.6|||||TWO_SIDED|90.0|0.32|6.89||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||6.89|0.32|
71714729|NCT01405196|142945285|SUPERIORITY||LS mean difference|0.91|||||TWO_SIDED|90.0|-2.38|4.19||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||4.19|-2.38|
71714730|NCT01405196|142945285|SUPERIORITY||LS mean difference|0.6|||||TWO_SIDED|90.0|-2.68|3.88||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.||3.88|-2.68|
71714731|NCT01729039|142945286|SUPERIORITY|||||||0.356||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.356
71714732|NCT01729039|142945286|SUPERIORITY|||||||0.84||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.840
71714733|NCT01729039|142945287|SUPERIORITY|||||||0.17||||||Main effect of Time (baseline to post-PT) Alpha=.05|ANOVA|||||||.170
71767352|NCT03207438|143036334|SUPERIORITY||Chi-squared|3.87||||0.02|TWO_SIDED||||||Chi-squared, Corrected|||Week 2 - chi-squared test comparing response rates between groups.||||.02
71767353|NCT03207438|143036334|SUPERIORITY||Chi-squared|0.62||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||Week 4 - chi-squared test comparing response rates between groups.||||.22
71767354|NCT03207438|143036334|SUPERIORITY||Chi-squared|2.45||||0.059|TWO_SIDED||||||Chi-squared, Corrected|||Week 6 - chi-squared test comparing response rates between groups.||||.059
71767355|NCT01512667|143036362|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|1.6|||||TWO_SIDED|90.0|1.15|2.23||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.||2.23|1.15|
71767356|NCT01512667|143036363|SUPERIORITY_OR_OTHER||GMR|1.46|||||TWO_SIDED|90.0|1.18|1.81||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.||1.81|1.18|
71714734|NCT01729039|142945287|SUPERIORITY|||||||0.297||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.297
71714735|NCT01729039|142945288|SUPERIORITY||||||<|0.001|||||||ANOVA|Main effect of Time (baseline to post-PT) alpha = .05||||||<.001
71714736|NCT01729039|142945288|SUPERIORITY|||||||0.817||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.817
71714737|NCT01729039|142945289|SUPERIORITY|||||||0.005||||||Main effect of Time (baseline to post-PT) alpha = .05|ANOVA|||||||.005
71714738|NCT01729039|142945289|SUPERIORITY|||||||0.172||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA|||||||.172
71714739|NCT01729039|142945290|SUPERIORITY|||||||0.009||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA|||||||.009
71714740|NCT01729039|142945290|SUPERIORITY|||||||0.146||||||Interaction of Time by Grou (GS vs. CON) alpha = .05|ANOVA|||||||.146
71714741|NCT01585025|142945309|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.007
71714742|NCT01585025|142945309|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.11
71714743|NCT01585025|142945309|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment||||0.12
71714744|NCT01585025|142945310|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.72
71714745|NCT01585025|142945310|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.51
71714746|NCT01585025|142945310|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC||||0.13
71714747|NCT01585025|142945311|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.03
71714748|NCT01585025|142945311|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.11
71714749|NCT01585025|142945311|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4||||0.02
71714750|NCT01585025|142945312|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
71714751|NCT01585025|142945312|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.04
71714752|NCT01585025|142945312|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC||||0.02
71714753|NCT01585025|142945313|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.03
71714754|NCT01585025|142945313|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.17
71714755|NCT01585025|142945313|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week||||0.31
71828230|NCT04035668|143160995|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.663|TWO_SIDED|95.0|-0.62|0.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||0.96|-0.62|0.663
71886907|NCT03979274|143294251|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.73|||||TWO_SIDED|90.0|98.45|101.03||||||||101.03|98.45|
71886908|NCT03979274|143294252|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric mean ratio|99.26|||||TWO_SIDED|90.0|97.7|100.85||||||||100.85|97.70|
71886909|NCT01665144|143294258|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0134|TWO_SIDED|95.0|0.65|0.95|||Cox proportional hazards model|||||0.95|0.65|0.0134
71886910|NCT01665144|143294259|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4398|TWO_SIDED|95.0|0.8|1.1|||Cox proportional hazards model|||||1.10|0.80|0.4398
71714756|NCT01585025|142945314|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.05
71714757|NCT01585025|142945314|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.04
71714758|NCT01585025|142945314|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form||||0.74
71714759|NCT01585025|142945315|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.005
71714760|NCT01585025|142945315|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.03
71714761|NCT01585025|142945315|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score||||0.61
71714762|NCT00582907|142945316|SUPERIORITY_OR_OTHER||Risk Ratio, log|-1.7|STANDARD_DEVIATION|0.78||0.027|TWO_SIDED|95.0|-3.4|-0.1|||Signed rank|||Based upon FMF colchicine controlled studies showing an \~80% decrease in attacks, we estimated, based on baseline attacks every 4 weeks, there would be a difference of 0.5 attacks per month between rilonacept and placebo. With a two-sided 5% significance level and power of 80% we aimed for 14 evaluable participants who completed at least 2 treatment courses. The null hypothesis is that there would be no significant differences in the number of attacks between use of rilonacept and placebo.||-0.1|-3.4|0.027
71886911|NCT01665144|143294260|SUPERIORITY||Mean Difference (Final Values)|-613.1|STANDARD_ERROR_OF_MEAN|95.39|<|0.0001|TWO_SIDED|95.0|-800.2|-426.0|||Mixed model for repeated measures|||Month 12||-426.0|-800.2|<0.0001
71714763|NCT00582907|142945316|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|STANDARD_DEVIATION|0.12||||95.0|0.39|0.85|||Bayesian modeling||Attacks while receiving rilonacept is the numerator and attacks while receiving placebo is the denominator. In Bayesian statistics credible interval equals confidence interval.|This analysis was done by Bayesian Statistics using a non-informative (neutral) prior (log normal distribution mean 9 \[SD 10\]). The null hypothesis was that the rilonacept/placebo FMF odds ratio of attacks was 1.||0.85|0.39|
71714764|NCT00582907|142945317|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|1.26||0.047|TWO_SIDED|95.0|-4.0|0.0|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of injection site reactions. No power calculations for this outcome.||0|-4|0.047
71714765|NCT00582907|142945317|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.13|TWO_SIDED|95.0|-0.56|0.17|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of infections. No power calculations for this outcome.||0.17|-0.56|0.13
71714766|NCT00582907|142945318|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|0.5||0.32||95.0|-2.4|0.5|||Signed rank|||Null hypothesis: There were no significant differences in the length of attacks during rilonacept vs. placebo treatment courses. Since this was a secondary outcome there were no power calculations performed.||0.5|-2.4|0.32
71714767|NCT00582907|142945319|SUPERIORITY_OR_OTHER||Differences in percent of courses|29.0||||0.004||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses without attacks between rilonacept and placebo. As a secondary measure there were no power calculations.||||0.004
71767357|NCT00770146|143036366|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.||||<0.001
71714768|NCT00582907|142945320|SUPERIORITY_OR_OTHER||Difference in percent of courses|40.0||||0.006||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses attaining at least a 50% decrease in attacks when compared to baseline between rilonacept and placebo courses.Since this was a secondary measure there were no power calculations.||||0.006
71714769|NCT00582907|142945321|SUPERIORITY_OR_OTHER||Log Rank|0.009||||0.009||95.0|||||Kaplan-Meier survival analysis|||Null hypothesis: There were no significant differences between rilonacept and placebo in the number of days from the start of the treatment course until the development of the a second attack.||||0.009
71714770|NCT00582907|142945322|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.5||||0.156|TWO_SIDED|95.0|-0.5|12.5|||Signed Rank|||Null hypothesis: There are no significant differences in the erythrocyte sedimentation rate between rilonacept and placebo. As a secondary measure there were no power calculations.||12.5|-0.5|0.156
71714771|NCT00582907|142945323|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.04||||0.22|TWO_SIDED|95.0|-0.03|0.29|||Signed Rank|||Null hypothesis: There are no differences in the C-reactive protein levels between the treatment courses. Since this was a secondary outcome measure no power calculations were performed.||0.29|-0.03|0.22
71886912|NCT01665144|143294260|SUPERIORITY||Mean Difference (Final Values)|-777.5|STANDARD_ERROR_OF_MEAN|108.62|<|0.0001|TWO_SIDED|95.0|-990.6|-564.4|||Mixed model for repeated measures|||Month 24||-564.4|-990.6|<0.0001
71886913|NCT01665144|143294260|SUPERIORITY||Mean Difference (Final Values)|-695.3|STANDARD_ERROR_OF_MEAN|92.79|<|0.0001|TWO_SIDED|95.0|-877.3|-513.3|||Mixed model for repeated measures|||Average over Month 12 and Month 24||-513.3|-877.3|<0.0001
71886914|NCT01665144|143294261|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0058|TWO_SIDED|95.0|0.6|0.92|||Cox proportional hazards model|||||0.92|0.60|0.0058
71886915|NCT01665144|143294262|SUPERIORITY||ARR ratio|0.445|||<|0.0001|TWO_SIDED|95.0|0.337|0.587|||Negative binomial regression model|||||0.587|0.337|<0.0001
71886916|NCT01665144|143294263|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.7|||Cox proportional hazards model|||||0.70|0.41|<0.0001
71886917|NCT01665144|143294265|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.03||0.0764|TWO_SIDED|95.0|-3.85|0.19|||Repeated measures model|||Month 12||0.19|-3.85|0.0764
71767358|NCT00770146|143036368|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
71767359|NCT00770146|143036370|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71767360|NCT00770146|143036372|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)|||||||<0.001
71767361|NCT00770146|143036374|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
71767362|NCT00770146|143036376|SUPERIORITY_OR_OTHER|||||||0.977||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.977
71767363|NCT00770146|143036378|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
71714772|NCT00582907|142945324|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.4||||0.078|TWO_SIDED|95.0|0.4|78.1|||Signed Rank|||Null hypothesis: There were no differences between the platelet count between the rilonacept and placebo courses. Since this was a secondary outcome no power calculations were performed.||78.1|0.4|0.078
71714773|NCT00582907|142945325|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.0||||0.063|TWO_SIDED|95.0|6.5|139.5|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the fibrinogen level. Since this was a secondary outcome no power calculations were performed.||139.5|6.5|0.063
71714774|NCT00582907|142945326|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5|TWO_SIDED|95.0|-4.0|0.0|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the serum amyloid A levels. Since this was a secondary outcome no power calculations were performed.||0|-4|0.50
71767364|NCT00770146|143036380|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
71767365|NCT00770146|143036382|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
71714775|NCT00582907|142945327|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.5||||0.021|TWO_SIDED|95.0|-11.1|-2.3|||Signed rank|||Null hypothesis: There are no significant differences in the physical health-related quality of life between rilonacept and placebo. As a secondary measure there were no power calculations.||-2.3|-11.1|0.021
71714776|NCT00582907|142945327|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.2||||0.42|TWO_SIDED|95.0|-6.8|3.9|||Signed Rank|||||3.9|-6.8|0.42
71714777|NCT00582907|142945328|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.136|TWO_SIDED|95.0|-2.3|9.8|||Signed rank|||Null hypothesis: There are no significant differences in the FMF Armenian Evaluation (severity) Score between rilonacept and placebo. As a secondary measure there were no power calculations.||9.8|-2.3|0.136
71767366|NCT00770146|143036384|SUPERIORITY_OR_OTHER|||||||0.032||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.032
71767367|NCT00816023|143036391|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Jonckheere-Terpstra|||||||0.474
71767368|NCT05027971|143036401|OTHER||Proportion by cohort|0.02|||||TWO_SIDED|95.0|0.002|0.07||||||||.07|.002|
71767369|NCT05027971|143036402|OTHER||Proportion by cohort|0.03|||||TWO_SIDED|95.0|0.006|0.084||||||||.084|.006|
71767370|NCT05027971|143036403|OTHER||Proportion by cohort|0.667|||||TWO_SIDED|95.0|0.553|0.768||||||||.768|.553|
71828231|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-1.35|0.11|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||0.11|-1.35|
71714778|NCT00582907|142945329|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.0||||0.089|TWO_SIDED|95.0|-15.0|-1.0|||Signed rank|||Null hypothesis: There are no significant differences in the proportion of time participants were treated with rilonacept and placebo. As a secondary measure there were no power calculations.||-1|-15|0.089
71767371|NCT05027971|143036404|OTHER||Mean Difference (Final Values)|-15.8|||||TWO_SIDED|95.0|-17.4|-14.2||||||||-14.2|-17.4|
71767372|NCT05027971|143036407|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
71767373|NCT05027971|143036408|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
71767374|NCT05027971|143036409|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
71767375|NCT05027971|143036410|OTHER||Proportion by cohort|0.889|||||TWO_SIDED|95.0|0.81|0.943||||||||.943|.810|
71767376|NCT05027971|143036411|OTHER||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|11.3|18.6||||||||18.6|11.3|
71767377|NCT05027971|143036412|OTHER||Mean Difference (Final Values)|-3.4|||||TWO_SIDED|95.0|-3.9|-2.9||||||||-2.9|-3.9|
71767378|NCT05027971|143036413|OTHER||Proportion by cohort|1.0|||||TWO_SIDED|95.0|0.963|1.0||||||||1|.963|
71767379|NCT02486627|143036414|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|-3.4|||||TWO_SIDED|95.0|-10.0|3.1||||||||3.1|-10|
71767380|NCT02486627|143036415|NON_INFERIORITY|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|11.6|||||TWO_SIDED|95.0|2.7|20.3||||||||20.3|2.7|
71767381|NCT00445588|143036445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4|TWO_SIDED|95.0|0.6|1.3||cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure|Regression, Cox|cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure||The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.||1.3|0.6|0.4
71767382|NCT03554486|143036447|OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
71767383|NCT03554486|143036448|OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71767384|NCT03554486|143036449|OTHER|||||||0.74|||||||t-test, 2 sided|||||||0.74
71828232|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.42|0.26|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||0.26|-1.42|
71767385|NCT01738477|143036467|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to diphtheria.||9.95|-3.25|
71767386|NCT01738477|143036467|NON_INFERIORITY|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to tetanus.||9.95|-3.25|
71767387|NCT00029146|143036558|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.7||||0.78||95.0|-10.4|13.8|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.||13.8|-10.4|0.78
71767388|NCT00029146|143036559|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|3.5||||0.59|TWO_SIDED|95.0|-9.2|16.1|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors.||16.1|-9.2|0.59
71767389|NCT00029146|143036560|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-3.2||||0.27|TWO_SIDED|95.0|-9.0|2.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Negative indicates lower rate in non-surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||2.6|-9.0|0.27
71767390|NCT00029146|143036561|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.3||||0.5|TWO_SIDED|95.0|-2.5|5.2|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||5.2|-2.5|0.50
71767391|NCT00029146|143036562|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.0||||0.13|TWO_SIDED|95.0|-1.2|9.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||9.7|-1.2|0.13
71767392|NCT00029146|143036563|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|6.5||||0.33|TWO_SIDED|95.0|-6.5|19.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||19.6|-6.5|.33
71767393|NCT00029146|143036564|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|-6.6||||0.41|TWO_SIDED|95.0|-20.6|7.3|||Fisher Exact||Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.|||7.3|-20.6|0.41
71767394|NCT00029146|143036565|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|4.4||||0.7|TWO_SIDED|95.0|-8.2|16.9|||Fisher Exact||Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.|||16.9|-8.2|0.70
71767395|NCT00029146|143036566|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher's Exact Test|||||||0.85
71828233|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-1.31|0.42|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||0.42|-1.31|
71828234|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-1.44|0.31|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||0.31|-1.44|
71767396|NCT00029146|143036567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.13|TWO_SIDED|95.0|-0.54|0.07|||t-test, 2 sided||Negative indicates lower score in non-surgical group.A higher score indicates better quality of life|||0.07|-0.54|0.13
71767397|NCT00029146|143036568|SUPERIORITY_OR_OTHER||Difference in estimated 2 yr rates|1.5||||0.81|TWO_SIDED|95.0|-10.7|13.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.||Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.||13.7|-10.7|0.81
71767398|NCT00043550|143036583|SUPERIORITY|The proposed sample size had at least 80% power to detect effect sizes of 0.36 between the two active treatment conditions and placebo during the active phase. These power calculations were based on a priori values of within-subject correlation of 0.50, 10% attrition, and 6 assessment points.|Slope|1.0||||0.95|TWO_SIDED|||||Overall significant effect for treatment, as well as the two moderating effects, used a Bonferroni-corrected alpha level of 0.0167 (0.05/3).|HLM|||Comparison of conditions||||.95
71767399|NCT00043550|143036583|SUPERIORITY||||||<|0.0001|||||||HLM|||effects of conditions over time||||<.0001
71828235|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||0.65|-1.39|
71661055|NCT03433755|142835773|SUPERIORITY||Treatment difference|82.7|||<|0.0001|TWO_SIDED|95.0|64.8|89.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test adjusted by the stratification factor.|Treatment difference = Evolocumab QM - Placebo QM|||89.7|64.8|< 0.0001
71767400|NCT00043550|143036583|SUPERIORITY||Slope|0.03|||||TWO_SIDED|95.0|-0.35|0.41||||||||.41|-.35|
71714779|NCT01453166|142945330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.0|STANDARD_DEVIATION|19.0|<|0.05||95.0|100.0|140.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||140|100|<0.05
71714780|NCT01453166|142945331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.0|STANDARD_DEVIATION|15.0||0.05||95.0|66.0|95.0|||ANOVA|||||95|66|0.05
71714781|NCT01453166|142945332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|170.0|STANDARD_DEVIATION|39.0||0.05||95.0|140.0|220.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||220|140|0.05
71714782|NCT01453166|142945333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|12.0||0.05||95.0|88.0|112.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||112|88|0.05
71714783|NCT01453166|142945334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|STANDARD_DEVIATION|30.0||0.05||95.0|77.0|137.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values \<0.05. All analyzes were performed following the principle of intention to treat."||137|77|0.05
71714784|NCT00854360|142945378|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.255|TWO_SIDED|95.0|-0.8|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.80|0.255
71714785|NCT00854360|142945378|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.25||0.257|TWO_SIDED|95.0|-0.78|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.21|-0.78|0.257
71714786|NCT00854360|142945378|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.25||0.013|TWO_SIDED|95.0|-1.13|-0.13||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.13|-1.13|0.013
71828236|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-1.39|0.65|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||0.65|-1.39|
71714787|NCT00854360|142945379|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.278|TWO_SIDED|95.0|-0.77|0.22||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.22|-0.77|0.278
71714788|NCT00854360|142945379|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.385|TWO_SIDED|95.0|-0.7|0.27||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.27|-0.70|0.385
71714789|NCT00854360|142945379|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.016|TWO_SIDED|95.0|-1.09|-0.11||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated Measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.11|-1.09|0.016
71767401|NCT00043550|143036583|SUPERIORITY||Slope|0.06|||||TWO_SIDED|95.0|-0.33|0.45||||||||.45|-.33|
71767402|NCT02081859|143036603|OTHER|||||||0.41|||||||Chi-squared|||||||0.41
71767403|NCT02081859|143036604|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
71828237|NCT04035668|143160995|OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.37|0.57|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||0.57|-1.37|
71828238|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|-2.73||||0.94|TWO_SIDED|95.0|-6.18|0.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||0.73|-6.18|0.940
71828239|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.322|TWO_SIDED|95.0|-2.95|4.74||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||4.74|-2.95|0.322
71828240|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.753|TWO_SIDED|95.0|-5.32|2.59||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||2.59|-5.32|0.753
71714790|NCT00854360|142945380|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.26||0.082|TWO_SIDED|95.0|-0.95|0.06||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.06|-0.95|0.082
71714791|NCT00854360|142945380|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.114|TWO_SIDED|95.0|-0.9|0.1||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.10|-0.90|0.114
71714792|NCT00854360|142945380|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|95.0|-1.33|-0.33||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||-0.33|-1.33|0.001
71714793|NCT00854360|142945381|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.747|TWO_SIDED|95.0|-0.52|0.37||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.37|-0.52|0.747
71714794|NCT00854360|142945381|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.605|TWO_SIDED|95.0|-0.53|0.31||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.31|-0.53|0.605
71714795|NCT00854360|142945381|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.083|TWO_SIDED|95.0|-0.84|0.05||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p\<0.05.||0.05|-0.84|0.083
71714796|NCT00854360|142945382|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.989|TWO_SIDED|95.0|-0.45|0.46||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.46|-0.45|0.989
71714797|NCT00854360|142945382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.808|TWO_SIDED|95.0|-0.39|0.5||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.50|-0.39|0.808
71714798|NCT00854360|142945382|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.23||0.195|TWO_SIDED|95.0|-0.74|0.15||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.15|-0.74|0.195
71714799|NCT00854360|142945383|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.31||0.903|TWO_SIDED|95.0|-0.64|0.57||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.57|-0.64|0.903
71828241|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.891|TWO_SIDED|95.0|-7.13|1.66||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||1.66|-7.13|0.891
71714800|NCT00854360|142945383|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.952|TWO_SIDED|95.0|-0.58|0.62||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.62|-0.58|0.952
71767404|NCT00492063|143036613|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.||3|-3|
71828242|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.941|TWO_SIDED|95.0|-8.77|1.01||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||1.01|-8.77|0.941
71828243|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.304|TWO_SIDED|95.0|-4.01|6.79||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|6.79|-4.01|0.304
71661056|NCT03433755|142835774|SUPERIORITY||Treatment difference|-48.45|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.78|-39.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.11|-57.78|< 0.0001
71828244|NCT04035668|143160996|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.64|TWO_SIDED|95.0|-6.89|4.79||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||4.79|-6.89|0.640
71661057|NCT03433755|142835774|SUPERIORITY||Treatment difference|-40.43|STANDARD_ERROR_OF_MEAN|4.13|<|0.0001|TWO_SIDED|95.0|-48.62|-32.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-32.24|-48.62|< 0.0001
71661058|NCT03433755|142835775|SUPERIORITY||Treatment difference|-44.7|STANDARD_ERROR_OF_MEAN|5.07|<|0.0001|TWO_SIDED|95.0|-54.76|-34.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-34.65|-54.76|< 0.0001
71661059|NCT03433755|142835775|SUPERIORITY||Treatment difference|-38.26|STANDARD_ERROR_OF_MEAN|5.88|<|0.0001|TWO_SIDED|95.0|-49.94|-26.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-26.59|-49.94|< 0.0001
71661060|NCT03433755|142835776|SUPERIORITY||Treatment difference|-15.09|STANDARD_ERROR_OF_MEAN|4.71||0.008|TWO_SIDED|95.0|-24.44|-5.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.75|-24.44|0.008
71661061|NCT03433755|142835776|SUPERIORITY||Treatment difference|-19.67|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-28.3|-11.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-11.05|-28.30|< 0.0001
71661062|NCT03433755|142835777|SUPERIORITY||Treatment difference|-17.56|STANDARD_ERROR_OF_MEAN|5.98||0.008|TWO_SIDED|95.0|-29.42|-5.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-5.69|-29.42|0.008
71661063|NCT03433755|142835777|SUPERIORITY||Treatment difference|-12.35|STANDARD_ERROR_OF_MEAN|5.38|<|0.0001|TWO_SIDED|95.0|-23.04|-1.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-1.67|-23.04|< 0.0001
71661064|NCT03433755|142835778|SUPERIORITY||Treatment difference|8.44|STANDARD_ERROR_OF_MEAN|2.56||0.008|TWO_SIDED|95.0|3.35|13.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.52|3.35|0.008
71661065|NCT03433755|142835778|SUPERIORITY||Treatment difference|6.8|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|2.1|11.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.50|2.10|0.017
71661066|NCT03433755|142835779|SUPERIORITY||Treatment difference|7.94|STANDARD_ERROR_OF_MEAN|2.91||0.008|TWO_SIDED|95.0|2.18|13.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||13.71|2.18|0.008
71661067|NCT03433755|142835779|SUPERIORITY||Treatment difference|6.17|STANDARD_ERROR_OF_MEAN|0.036||0.017|TWO_SIDED|95.0|0.42|11.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||11.92|0.42|0.017
71661068|NCT03433755|142835780|SUPERIORITY||Treatment difference|-22.96|STANDARD_ERROR_OF_MEAN|4.44||0.0002|TWO_SIDED|95.0|-33.12|-12.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-12.81|-33.12|0.0002
71661069|NCT03433755|142835780|SUPERIORITY||Treatment difference|-27.81|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|-36.6|-19.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-19.02|-36.60|< 0.0001
71661070|NCT03433755|142835781|SUPERIORITY||Treatment difference|-21.78|STANDARD_ERROR_OF_MEAN|6.32||0.0002|TWO_SIDED|95.0|-34.31|-9.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-9.25|-34.31|0.0002
71714801|NCT00854360|142945383|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.187|TWO_SIDED|95.0|-0.99|0.19||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p\<0.05.||0.19|-0.99|0.187
71828245|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|2.32|||||TWO_SIDED|95.0|-1.44|6.07|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||6.07|-1.44|
71714802|NCT02441218|142945392|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.75|0.9|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.90|0.75|<0.0001
71714803|NCT02441218|142945393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.128|TWO_SIDED|95.0|0.8|1.03|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.03|0.80|0.128
71714804|NCT02441218|142945394|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.83|0.66|< 0.0001
71714805|NCT02441218|142945395|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.8|1.02|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||1.02|0.80|0.092
71714806|NCT02441218|142945396|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.014|TWO_SIDED|95.0|0.58|0.94|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.94|0.58|0.0140
71714807|NCT02441218|142945397|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.0027|TWO_SIDED|95.0|0.82|0.96|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.96|0.82|0.0027
71714808|NCT02441218|142945398|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.78|0.0002
71714809|NCT02441218|142945399|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.95|0.81|0.0013
71714810|NCT02441218|142945400|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0002|TWO_SIDED|95.0|0.77|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"|||0.92|0.77|0.0002
71714811|NCT02441218|142945401|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate. P-value: Wald test|||0.89|0.74|< 0.0001
71714812|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.253|TWO_SIDED|95.0|-3.1|0.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.8|-3.1|0.253
71714813|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.1||||0.919|TWO_SIDED|95.0|-2.1|1.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.9|-2.1|0.919
71714814|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.2||||0.829|TWO_SIDED|95.0|-2.2|1.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.8|-2.2|0.829
71714815|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.1||||0.074|TWO_SIDED|95.0|-4.5|0.2|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.2|-4.5|0.074
71714816|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|1.0||||0.393|TWO_SIDED|95.0|-1.3|3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||3.3|-1.3|0.393
71828246|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-3.46|5.18|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||5.18|-3.46|
71714817|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|2.0||||0.088|TWO_SIDED|95.0|-0.3|4.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.4|-0.3|0.088
71714818|NCT00806585|142945424|SUPERIORITY_OR_OTHER||Difference in least squares means|1.9||||0.108|TWO_SIDED|95.0|-0.4|4.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||4.3|-0.4|0.108
71714819|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.543|TWO_SIDED|95.0|-4.0|2.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.1|-4.0|0.543
71828247|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.43|4.83|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||4.83|-4.43|
71828248|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|0.63|||||TWO_SIDED|95.0|-4.53|5.78|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.78|-4.53|
71828249|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|-4.6|6.82|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||6.82|-4.60|
71828250|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|5.69|||||TWO_SIDED|95.0|-0.66|12.04|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||12.04|-0.66|
71828251|NCT04035668|143160996|OTHER||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-3.53|10.59|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||10.59|-3.53|
71661071|NCT03433755|142835781|SUPERIORITY||Treatment difference|-15.74|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|95.0|-26.31|-5.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Includes treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference = Evolocumab QM - Placebo QM|||-5.18|-26.31|< 0.0001
71828252|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.494|TWO_SIDED|95.0|-7.84|7.96||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||7.96|-7.84|0.494
71661072|NCT02081209|142835822|OTHER||sucess percentage|82.4|||||TWO_SIDED|95.0|76.4|87.3||||||||87.3|76.4|
71661073|NCT02081209|142835822|OTHER||sucess percentage|77.4|||||TWO_SIDED|95.0|68.1|85.1||||||||85.1|68.1|
71661074|NCT02081209|142835822|OTHER||sucess percentage|79.2|||||TWO_SIDED|95.0|65.0|89.5||||||||89.5|65.0|
71661075|NCT02081209|142835822|OTHER||sucess percentage|94.0|||||TWO_SIDED|95.0|84.6|98.8||||||||98.8|84.6|
71661076|NCT02081209|142835823|OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|1.9|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71661077|NCT02081209|142835823|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.5|2.1||||||||2.1|0.5|
71661078|NCT02081209|142835823|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|2.0|4.1||||||||4.1|2.0|
71661079|NCT02081209|142835824|OTHER||||||||||||||||||Data from the 16-week follow-up questionnaire were tabulated for all subjects with completed questionnaires.. All confidence intervals were calculated at 95%. Alpha was calculated to be 0.05, critical probability (p\*) was calculated to be 0.975. Assuming normal distribution of survey recipients, a standard deviation of 1.96 is used to calculate the standard margin of error.|||
71661080|NCT05205772|142835825|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71661081|NCT05205772|142835825|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71661082|NCT05205772|142835825|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71661083|NCT05205772|142835825|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
71661084|NCT05205772|142835825|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
71661085|NCT05205772|142835825|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
71661086|NCT05205772|142835826|OTHER|||||||0.38||||||Adjusted for age.|Regression, Linear|||||||0.38
71661087|NCT05205772|142835827|OTHER|||||||0.67||||||Adjusted for age.|Regression, Linear|||||||0.67
71661088|NCT05205772|142835828|OTHER|||||||0.156|||||||Regression, Linear|||||||0.156
71661089|NCT04994483|142835840|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4308|TWO_SIDED|95.0|-1.37|0.59|||Mixed Models Analysis|||||0.59|-1.37|0.4308
71661090|NCT04994483|142835841|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.4034|TWO_SIDED|95.0|-0.68|1.7|||Mixed Models Analysis|||||1.70|-0.68|0.4034
71661091|NCT03589768|142835852|OTHER|N/A, Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-11.9|10.3|||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||10.3|-11.9|
71661092|NCT03589768|142835853|SUPERIORITY||Risk Difference (RD)|4.62||||0.559|TWO_SIDED|95.0|-6.25|15.5|||Fisher Exact||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|||15.5|-6.25|0.559
71661093|NCT03589768|142835854|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-9.3|9.8|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|9.8|-9.3|
71661094|NCT03589768|142835855|SUPERIORITY||Risk Difference (RD)|6.06||||0.29|TWO_SIDED|95.0|-3.82|15.9|||Fisher Exact||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|15.9|-3.82|0.290
71661095|NCT03589768|142835857|OTHER|Only risk difference estimated and 95% CI reported.|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-6.4|7.3|||||||Difference is calculated as the proportion in the BOOSTRIX group minus the proportion in the Td group.|7.3|-6.4|
71661096|NCT03589768|142835858|SUPERIORITY||Ratio|7.0|||<|0.0001|TWO_SIDED|95.0|4.6|10.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth day timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|10.7|4.6|<0.0001
71661097|NCT03589768|142835858|SUPERIORITY||Ratio|4.8|||<|0.0001|TWO_SIDED|95.0|3.2|7.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for Prior to receipt of first dose of DTwP (approximately 6 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|7.3|3.2|<0.0001
71661098|NCT03589768|142835858|SUPERIORITY||Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.8|4.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of first dose of DTwP (approximately 10 weeks of age) timepoint|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|4.8|1.8|<0.0001
71661099|NCT03589768|142835858|SUPERIORITY||Ratio|0.3||||0.0068|TWO_SIDED|95.0|0.1|0.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for One month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.7|0.1|0.0068
71661100|NCT03589768|142835858|SUPERIORITY||Ratio|0.3||||0.0003|TWO_SIDED|95.0|0.1|0.5|||t-test, 2 sided|Test compares differences in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.5|0.1|0.0003
71661101|NCT03589768|142835859|SUPERIORITY||Ratio|0.9||||0.7102|TWO_SIDED|95.0|0.7|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.7|0.7102
71714820|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.8||||0.246|TWO_SIDED|95.0|-4.9|1.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||1.3|-4.9|0.246
71714821|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.4||||0.821|TWO_SIDED|95.0|-3.5|2.7|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||2.7|-3.5|0.821
71714822|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.0|||<|0.001|TWO_SIDED|95.0|-10.7|-3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-3.3|-10.7|<0.001
71714823|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|6.1||||0.001|TWO_SIDED|95.0|2.4|9.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||9.8|2.4|0.001
71714824|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|5.2||||0.006|TWO_SIDED|95.0|1.5|8.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||8.9|1.5|0.006
71714825|NCT00806585|142945425|SUPERIORITY_OR_OTHER||Difference in least squares means|6.7|||<|0.001|TWO_SIDED|95.0|3.0|10.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||10.4|3.0|<0.001
71714826|NCT00806585|142945426|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.4||||0.684|TWO_SIDED|95.0|-8.3|5.5|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.5|-8.3|0.684
71714827|NCT00806585|142945426|SUPERIORITY_OR_OTHER||Difference in least squares means|1.8||||0.597|TWO_SIDED|95.0|-5.0|8.7|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||8.7|-5.0|0.597
71714828|NCT00806585|142945426|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0.793|TWO_SIDED|95.0|-7.6|5.8|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||5.8|-7.6|0.793
71714829|NCT00806585|142945426|SUPERIORITY_OR_OTHER||Difference in least squares means|0.8||||0.854|TWO_SIDED|95.0|-7.6|9.2|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect||||9.2|-7.6|0.854
71714830|NCT00806585|142945427|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.9||||0.006|TWO_SIDED|95.0|-3.2|-0.5|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.5|-3.2|0.006
71714831|NCT00806585|142945427|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.004|TWO_SIDED|95.0|-3.3|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.3|0.004
71714832|NCT00806585|142945427|SUPERIORITY_OR_OTHER||Diffference in least squares means|-1.3||||0.066|TWO_SIDED|95.0|-2.6|0.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.1|-2.6|0.066
71714833|NCT00806585|142945427|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.6|-3.7|0.008
71714834|NCT00806585|142945428|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.18||||0.152|TWO_SIDED|95.0|-0.44|0.07|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.07|-0.44|0.152
71714835|NCT00806585|142945428|SUPERIORITY_OR_OTHER||Difference in least sqaures means|-0.28||||0.035|TWO_SIDED|95.0|-0.54|-0.02|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.02|-0.54|0.035
71714836|NCT00806585|142945428|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.095|TWO_SIDED|95.0|-0.48|0.04|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||0.04|-0.48|0.095
71714837|NCT00806585|142945428|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.32||||0.045|TWO_SIDED|95.0|-0.63|-0.01|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment||||-0.01|-0.63|0.045
71714838|NCT00474903|142945429|SUPERIORITY_OR_OTHER|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||||||0.0955
71714839|NCT00474903|142945429|SUPERIORITY_OR_OTHER|||||||0.0204|||||||Wilcoxon (Mann-Whitney)|||||||0.0204
71714840|NCT01103414|142945443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|STANDARD_ERROR_OF_MEAN|6.77||0.1819|TWO_SIDED|95.0|-22.4|4.3|||ANCOVA|||||4.3|-22.4|0.1819
71714841|NCT01103414|142945443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.4|STANDARD_ERROR_OF_MEAN|6.59||0.0057|TWO_SIDED|95.0|-31.4|-5.4|||ANCOVA|||||-5.4|-31.4|0.0057
71714842|NCT01103414|142945443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.9|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|-42.3|-15.6|||ANCOVA|||||-15.6|-42.3|<0.0001
71714843|NCT01103414|142945443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|-43.8|-18.2|||ANCOVA|||||-18.2|-43.8|<0.0001
71714844|NCT01103414|142945444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0273|TWO_SIDED|95.0|-0.73|-0.04|||ANCOVA|||||-0.04|-0.73|0.0273
71714845|NCT01103414|142945444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.13|-0.45|||ANCOVA|||||-0.45|-1.13|<0.0001
71714846|NCT01103414|142945444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.21|-0.52|||ANCOVA|||||-0.52|-1.21|<0.0001
71714847|NCT01103414|142945444|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.98|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||ANCOVA|||||-0.65|-1.32|<0.0001
71714848|NCT03435380|142945454|SUPERIORITY||Risk Ratio (RR)|2.37||||0.019|TWO_SIDED|95.0|1.11|5.07|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||5.07|1.11|0.019
71714849|NCT03435380|142945454|SUPERIORITY||Risk Ratio (RR)|1.96||||0.092|TWO_SIDED|95.0|0.87|4.38|||Mantel Haenszel|Stratified by age at consent (25-39 vs \>=40), diagnosis (Hodgkin lymphoma vs other) and previous breast imaging exam (either mammogram or breast MRI).||||4.38|0.87|0.092
71714850|NCT02319486|142945474|SUPERIORITY_OR_OTHER||Probability of Event-Free Survival ，pEFS|0.32||||0.034|TWO_SIDED|||||stage 2 vs stage 3|pEFS||over all pEFS|||||0.034
71714851|NCT02493764|142945483|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was \< 10 percentage points.|Adjusted difference in ACM|-5.3|||<|0.001|TWO_SIDED|95.0|-11.9|1.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.2|-11.9|<0.001
71714852|NCT02493764|142945484|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 2-sided 95% CI for the difference in FCR (IMI/REL minus PIP/TAZ) was \> 12.5 percentage points.|Adjusted difference in FCR|5.0|||<|0.001|TWO_SIDED|95.0|-3.2|13.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in FCR||13.2|-3.2|<0.001
71714853|NCT02493764|142945485|OTHER|Difference in % with AE vs PIP/TAZ|Difference in % with AE|-1.7|||||TWO_SIDED|95.0|-7.7|4.3||||||||4.3|-7.7|
71714854|NCT02493764|142945486|OTHER|Difference in % discontinuing vs PIP/TAZ|Difference in % discontinuing|-2.5|||||TWO_SIDED|95.0|-7.1|1.8||||||||1.8|-7.1|
71714855|NCT02493764|142945487|OTHER||Adjusted difference in ACM|-3.5|||||TWO_SIDED|95.0|-10.9|3.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.6|-10.9|
71714856|NCT02493764|142945488|NON_INFERIORITY|Non-inferiority was declared when the upper bound of the 2-sided 95% CI for the difference in mortality (IMI/REL minus PIP/TAZ) was ≥ 10 percentage points.|Adjusted difference in ACM|-4.6|||||TWO_SIDED|95.0|-11.0|1.7|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||1.7|-11.0|
71714857|NCT02493764|142945489|OTHER|Adjusted difference in ACM|Adjusted difference in ACM|-3.1|||||TWO_SIDED|95.0|-10.2|3.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in all-cause mortality||3.8|-10.2|
71767405|NCT00492063|143036613|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.||2|-1|
71767406|NCT00492063|143036613|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.||3|-3|
71714858|NCT02493764|142945490|OTHER|Difference in FCR|Adjusted difference in FCR|-1.7|||||TWO_SIDED|95.0|-11.3|7.8|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.8|-11.3|
71714859|NCT02493764|142945491|OTHER|Difference in FCR|Adjusted difference in FCR|-2.2|||||TWO_SIDED|95.0|-9.8|5.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||5.5|-9.8|
71714860|NCT02493764|142945492|OTHER|Difference in favorable clinical response|Adjusted difference in FCR|6.6|||||TWO_SIDED|95.0|-4.6|18.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||18.4|-4.6|
71714861|NCT02493764|142945493|OTHER|Difference in FCR|Adjusted difference in FCR|-0.4|||||TWO_SIDED|95.0|-8.1|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-8.1|
71714862|NCT02493764|142945494|OTHER|Difference in FCR|Adjusted difference in FCR|-3.4|||||TWO_SIDED|95.0|-14.3|7.5|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.5|-14.3|
71714863|NCT02493764|142945495|OTHER|Difference in FCR|Adjusted difference in FCR|-3.7|||||TWO_SIDED|95.0|-13.6|6.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||6.4|-13.6|
71714864|NCT02493764|142945496|OTHER|Difference in FCR|Adjusted difference in FCR|3.5|||||TWO_SIDED|95.0|-4.6|11.6|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||11.6|-4.6|
71714865|NCT02493764|142945497|OTHER|Difference in FCR|Adjusted difference in FCR|0.5|||||TWO_SIDED|95.0|-6.3|7.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||7.4|-6.3|
71714866|NCT02493764|142945498|OTHER|Difference in FCR|Adjusted difference in FCR|3.4|||||TWO_SIDED|95.0|-7.1|14.2|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||14.2|-7.1|
71714867|NCT02493764|142945499|OTHER|Difference in FCR|Adjusted difference in FCR|4.4|||||TWO_SIDED|95.0|-3.1|12.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||12.0|-3.1|
71714868|NCT02493764|142945500|OTHER|Difference in FCR|Adjusted difference in FCR|1.1|||||TWO_SIDED|95.0|-7.2|9.4|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable clinical response||9.4|-7.2|
71714869|NCT02493764|142945501|OTHER|Difference in FMR|Adjusted difference in FMR|9.7|||||TWO_SIDED|95.0|1.6|17.9|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||17.9|1.6|
71714870|NCT02493764|142945502|OTHER|Difference in FMR|Adjusted difference in FMR|6.2|||||TWO_SIDED|95.0|-2.7|15.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||15.0|-2.7|
71714871|NCT02493764|142945503|OTHER|Difference in FMR|Adjusted difference in FMR|2.5|||||TWO_SIDED|95.0|-5.5|11.0|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||11.0|-5.5|
71714872|NCT02493764|142945504|OTHER|Difference in FMR|Adjusted difference in FMR|4.7|||||TWO_SIDED|95.0|-4.0|14.1|||||Adjusted difference and 95% CI are based on the Miettinen \& Nurminen method.|Adjusted difference in favorable microbiological response||14.1|-4.0|
71714873|NCT00859833|142945505|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.7||0.3617|TWO_SIDED|95.0|-0.6041|0.2241|||t-test, 2 sided|||Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.||0.2241|-0.6041|0.3617
71714874|NCT01561976|142945522|OTHER||Ratio|108.94||||0.1413|TWO_SIDED|95.0|101.01|117.5|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||117.50|101.01|0.1413
71714875|NCT01561976|142945522|OTHER||Ratio|107.24||||0.1413|TWO_SIDED|95.0|99.37|115.73|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||115.73|99.37|0.1413
71714876|NCT01561976|142945523|OTHER||Ratio|116.5||||0.0171|TWO_SIDED|95.0|106.91|126.95|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||126.95|106.91|0.0171
71714877|NCT01561976|142945523|OTHER||Ratio|107.24||||0.0171|TWO_SIDED|95.0|98.35|116.94|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||116.94|98.35|0.0171
71714878|NCT01561976|142945524|OTHER||Ratio|116.87||||0.0169|TWO_SIDED|95.0|107.07|127.57|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting|||127.57|107.07|0.0169
71714879|NCT01561976|142945524|OTHER||Ratio|107.38||||0.0169|TWO_SIDED|95.0|98.3|117.29|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting|||117.29|98.30|0.0169
71714880|NCT03218917|142945530|SUPERIORITY||||||=|0.014||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by Pseudomonas aeruginosa (Pa) colonization status and maintenance antibiotic use at Baseline.||||||= 0.014
71767407|NCT00492063|143036613|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.||3|-4|
71767408|NCT00492063|143036613|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||TWO_SIDED|95.0|-2.0|1.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.||1|-2|
71767409|NCT00492063|143036613|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with HI titer ≥40 in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.||4|-2|
71828253|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|-3.87||||0.866|TWO_SIDED|95.0|-10.81|3.06||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||3.06|-10.81|0.866
71828254|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.684|TWO_SIDED|95.0|-9.37|5.73||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||5.73|-9.37|0.684
71714881|NCT03218917|142945530|SUPERIORITY||||||=|0.022||||||P-value is one-sided for superiority.|Stratified Log-rank test|Stratified by colonization status and maintenance antibiotic use at Baseline.||||||= 0.022
71714882|NCT00427193|142945541|OTHER||difference in mean change|0.02|STANDARD_DEVIATION|0.02||0.7|TWO_SIDED|95.0|-0.019|0.059||Type I error was controlled using a hierarchical gatekeeping strategy.|Mixed Models Analysis|||All analysis under intention-to-treat. All observations were included The primary analytic was a repeated measures analysis. The dependent variable was the change from baseline 12 \& 14mos., with treatment, time, and the treatment × time interaction as independent variables. Site, sex, BMI stratum, and the baseline value of the outcome were included as covariates. The predicted mean changes ± standard errors are the adjusted values from the contrasts of the multiple timepoints.||0.059|-0.019|0.70
71714883|NCT00427193|142945542|OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.0092|0.069|||Mixed Models Analysis|||||0.069|-0.0092|0.84
71714884|NCT00427193|142945543|OTHER||Mean Difference (Net)|-82.0|STANDARD_ERROR_OF_MEAN|11.12|<|0.001|TWO_SIDED|95.0|-103.8|-60.2|||Mixed Models Analysis|||||-60.2|-103.8|<0.001
71714885|NCT00427193|142945544|OTHER||Mean Difference (Final Values)|-64.0|STANDARD_DEVIATION|13.5|<|0.0001|TWO_SIDED|95.0|-90.5|-37.5|||Mixed Models Analysis|||||-37.5|-90.5|<0.0001
71714886|NCT00427193|142945545|OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|95.0|-0.16|0.23|||Mixed Models Analysis|||||0.23|-0.16|0.82
71828255|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.908|TWO_SIDED|95.0|-10.93|2.14||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||2.14|-10.93|0.908
71828256|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.487|TWO_SIDED|95.0|-8.0|8.26||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||8.26|-8.00|0.487
71828257|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|-3.06||||0.79|TWO_SIDED|95.0|-10.61|4.49||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|4.49|-10.61|0.790
71767410|NCT00492063|143036614|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||7|-3|
71767411|NCT00492063|143036614|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||4|-6|
71656738|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.17|||||TWO_SIDED|95.0|-0.33|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||-0.01|-0.33|
71656739|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
71656740|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.04|-0.16|
71656741|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.1|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.10|-0.10|
71656742|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.09|-0.15|
71656743|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.16|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.16|
71656744|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.11|-0.13|
71656745|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.13|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.07|-0.13|
71656746|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.23|-0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.03|-0.23|
71656747|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.1|||||TWO_SIDED|95.0|-0.2|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.00|-0.20|
71661102|NCT03589768|142835859|SUPERIORITY||Ratio|8.7|||<|0.0001|TWO_SIDED|95.0|6.2|12.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|12.0|6.2|<0.0001
71714887|NCT00427193|142945546|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-6.5|-5.3|||Mixed Models Analysis|||Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) and Fat Free Mass (FFM) were determined for the whole body.||-5.3|-6.5|<0.001
71714888|NCT00427193|142945547|OTHER||Mean Difference (Net)|-5.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.4|-5.3|||Mixed Models Analysis|||Comparison of change in FM in 2 groups over at 24 mos, controlling for site, sex, BMI group, and baseline FM. A repeated measures Mixed Model was employed for the analysis. For any outcome, Type I error was controlled using a hierarchical gatekeeping strategy testing, first, the GroupXTime interaction, and, if non-significant, the main effects of these two factors. Bonferroni corrections were employed for non-significant effects. All tests were at p\<0.05||-5.3|-6.4|<0.0001
71714889|NCT01463527|142945548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||||TWO_SIDED|95.0|0.17|0.57||||||Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.||0.57|0.17|
71767412|NCT00492063|143036614|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||8|0|
71767413|NCT00492063|143036614|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|0.0|||||TWO_SIDED|95.0|-6.0|5.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||5|-6|
71767414|NCT00492063|143036614|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||8|-2|
71767415|NCT00492063|143036614|NON_INFERIORITY_OR_EQUIVALENCE|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is \>10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|6.0|||||TWO_SIDED|95.0|2.0|11.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||11|2|
71767416|NCT00492063|143036615|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.07|||||TWO_SIDED|95.0|0.9|1.28||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.||1.28|0.9|
71828258|NCT04035668|143160997|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.34|TWO_SIDED|95.0|-6.48|9.88||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||9.88|-6.48|0.340
71828259|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-9.06|8.68|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||8.68|-9.06|
71828260|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-9.59|6.17|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||6.17|-9.59|
71828261|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-9.34|8.74|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||8.74|-9.34|
71828262|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-3.94|||||TWO_SIDED|95.0|-11.74|3.86|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||3.86|-11.74|
71828263|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-4.71|||||TWO_SIDED|95.0|-14.34|4.93|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||4.93|-14.34|
71828264|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-6.29|||||TWO_SIDED|95.0|-15.44|2.87|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||2.87|-15.44|
71828265|NCT04035668|143160997|OTHER||Mean Difference (Final Values)|-3.92|||||TWO_SIDED|95.0|-14.01|6.16|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||6.16|-14.01|
71886918|NCT01665144|143294265|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.359||0.3671|TWO_SIDED|95.0|-3.89|1.44|||Repeated measures model|||Month 24||1.44|-3.89|0.3671
71714890|NCT01463527|142945549|SUPERIORITY|||||||0.3|||||||GEE (Generalized Estimating Equation)|||||||0.30
71828266|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.575|TWO_SIDED|95.0|-6.75|8.16||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 2||8.16|-6.75|0.575
71828267|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|-1.98||||0.294|TWO_SIDED|95.0|-9.22|5.27||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 4||5.27|-9.22|0.294
71828268|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.45|TWO_SIDED|95.0|-8.4|7.41||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 8||7.41|-8.40|0.450
71886919|NCT01665144|143294266|SUPERIORITY||Rate ratio|0.126|||<|0.0001|TWO_SIDED|95.0|0.083|0.191|||Negative binomial regression model|||Month 12||0.191|0.083|<0.0001
71886920|NCT01665144|143294266|SUPERIORITY||Rate ratio|0.178|||<|0.0001|TWO_SIDED|95.0|0.087|0.362|||Negative binomial regression model|||Month 24||0.362|0.087|<0.0001
71714891|NCT05136170|142945550|SUPERIORITY|The following null hypothesis was defined on this endpoint: the proportion of patients reaching a value of Schirmer I test (without anaesthesia) \>10mm/5min at week 4 in cenegermin (rhNGF) was lower or equal than control. The null hypothesis was rejected if the associated primary analysis p-value was lower than 0.025.|Odds Ratio (OR)|8.498||||0.002|TWO_SIDED|95.0|2.165|33.356||P-value of treatment variable from logistic regression model on proportion of patients reaching a value of Schirmer I test (without anesthesia) \>10mm/5min|Regression, Logistic|||Analysis was based on logistic regression model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \> 10 mm/5 min at Week 4 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||33.356|2.165|0.002
71714892|NCT05136170|142945551|SUPERIORITY|The following null hypothesis is defined on this endpoint: the change from baseline (reduction) in the global SANDE score at week 12 in cenegermin is lower or equal than control. The null hypothesis is rejected if the associated primary analysis p-value is lower than 0.025.|Adjusted means difference|0.59||||0.89|TWO_SIDED|95.0|-7.801|8.981||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in the global SANDE score.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under a missing not at random (MNAR) mechanism using retrieve dropouts with change from baseline in the global SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline global SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||8.981|-7.801|0.890
71714893|NCT05136170|142945552|SUPERIORITY|Analysis was based on logistic regression model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with proportion of patients reaching a value of Schirmer I test \>10 mm/5 min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as qualitative independent variables. Site was considered as random effects that vary randomly among patients.|Odds Ratio (OR)|6.648||||0.022|TWO_SIDED|95.0|1.307|33.808|||Regression, Logistic|||This key secondary endpoint was analyzed by means of a logistic regression model with proportion of patients reaching a value of Schirmer I test \>10mm/5min at Week 8 as dependent variable, treatment, gender, age class and baseline Schirmer I test value as fixed effects and site as random effect.||33.808|1.307|0.022
71714894|NCT05136170|142945553|SUPERIORITY||Adjusted means difference|0.221||||0.962|TWO_SIDED|95.0|-8.934|9.377||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for severity at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the severity SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline severity SANDE score as qualitative independent variables.Site was considered as random effects that vary randomly among patients.||9.377|-8.934|0.962
71828269|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.913|TWO_SIDED|95.0|-2.74|14.78||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 12||14.78|-2.74|0.913
71828270|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|2.59||||0.722|TWO_SIDED|95.0|-6.16|11.34||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 16||11.34|-6.16|0.722
71828271|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|-2.86||||0.241|TWO_SIDED|95.0|-10.96|5.24||one-sided p-value|MMRM|||Week 20|Difference (Any remibrutinib - Placebo)|5.24|-10.96|0.241
71828272|NCT04035668|143160998|SUPERIORITY||Mean Difference (Final Values)|2.95||||0.742|TWO_SIDED|95.0|-6.09|11.99||one-sided p-value|MMRM||Difference (Any remibrutinib - Placebo)|Week 24||11.99|-6.09|0.742
71828273|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-8.28|7.91|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 2||7.91|-8.28|
71828274|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-8.87|7.58|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 4||7.58|-8.87|
71828275|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-9.28|9.48|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 8||9.48|-9.28|
71886921|NCT01665144|143294267|SUPERIORITY||Rate ratio|0.266|||<|0.0001|TWO_SIDED|95.0|0.215|0.328|||Regression model|Repeated measures negative binomial regression model||Month 12||0.328|0.215|<0.0001
71828276|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|-4.4|||||TWO_SIDED|95.0|-14.71|5.9|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 12||5.90|-14.71|
71828277|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-22.47|-1.77|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 16||-1.77|-22.47|
71828278|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-16.0|3.5|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 20||3.50|-16.00|
71886922|NCT01665144|143294267|SUPERIORITY||Rate ratio|0.142|||<|0.0001|TWO_SIDED|95.0|0.103|0.196|||Regression model|Repeated measures negative binomial regression model||Month 24||0.196|0.103|<0.0001
71886923|NCT01665144|143294268|SUPERIORITY||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.0367|<|0.0001|TWO_SIDED|95.0|0.103|0.247|||Repeated measures model|||Month 12||0.247|0.103|<0.0001
71828279|NCT04035668|143160998|OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-19.16|2.96|||MMRM||Difference (remibrutinib 100 mg qd - remibrutinib 100 mg bid)|Week 24||2.96|-19.16|
71828280|NCT00738699|143161045|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13||||0.836|TWO_SIDED|95.0|0.88|1.46||One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).|Log Rank||Stratified as described above.|||1.46|0.88|0.8360
71886924|NCT01665144|143294268|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.0549||0.0196|TWO_SIDED|95.0|0.021|0.236|||Repeated measures model|||Month 24||0.236|0.021|0.0196
71886925|NCT01665144|143294269|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.11|||Cox proportional hazard model|||Without superimposed relapses at baseline||1.11|0.68|
71886926|NCT01665144|143294269|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.49|0.91|||Cox proportional hazard model|||With superimposed relapses at baseline||0.91|0.49|
71886927|NCT01665144|143294269|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||Cox proportional hazard model|||Without superimposed relapses post-treatment||1.06|0.69|
71767417|NCT00492063|143036615|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.||0.99|0.72|
71767418|NCT00492063|143036615|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.14|||||TWO_SIDED|95.0|0.99|1.3||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.||1.3|0.99|
71767419|NCT00492063|143036615|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.||1.12|0.82|
71828281|NCT00738699|143161046|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11||||0.7568|TWO_SIDED|95.0|0.83|1.48||One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.|Log Rank||Stratified as described above|||1.48|0.83|0.7568
71828282|NCT00738699|143161047|SUPERIORITY_OR_OTHER||Difference|-7.4||||0.0399|TWO_SIDED|95.0|-14.1|-0.7||Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.|Cochran-Mantel-Haenszel||(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.|||-0.7|-14.1|0.0399
71886928|NCT01665144|143294269|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.53|1.19|||Cox proportional hazard model|||With superimposed relapses post-treatment||1.19|0.53|
71714895|NCT05136170|142945554|SUPERIORITY||Adjusted means difference|0.164||||0.973|TWO_SIDED|95.0|-9.221|9.549||P-value of adjusted means difference between treatments from the ANCOVA model on change from baseline in SANDE score for frequency at Week 12.|ANCOVA|||Analysis was based on ANCOVA model with multiple imputation (MI) under missing not at random (MNAR) using retrieve dropouts with change from baseline in the frequency SANDE score at Week 12 as dependent variable, treatment, gender, age class and baseline frequency SANDE score as qualitative independent variables. Site was considered as random effects that vary randomly among patients.||9.549|-9.221|0.973
71714896|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|2.378||||0.52|TWO_SIDED|95.0|-4.869|9.625||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 4|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 4||9.625|-4.869|0.52
71714897|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|7.11||||0.073|TWO_SIDED|95.0|-0.653|14.873||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Daily Activities) at Week 12.|Mixed Model for Repeated Measures|||QoL (Daily Activities) - Week 12||14.873|-0.653|0.073
71714898|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-4.166||||0.317|TWO_SIDED|95.0|-12.322|3.989||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 4.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 4||3.989|-12.322|0.317
71714899|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixedmodel for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall"|LS means difference|1.058||||0.792|TWO_SIDED|95.0|-6.786|8.901||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Feelings) at Week 12.|Mixed Model for Repeated Measures|||QoL (Feelings) - Week 12||8.901|-6.786|0.792
71714900|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM). Analyses included the fixed, categorical effects of treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall. Missing data will be imputed according to the questionnaire manuals"|LS means difference|-3.907||||0.488|TWO_SIDED|95.0|-14.948|7.135||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 4.|Mixed Model for Repeated Measures|||QoL (Work) - Week 4||7.135|-14.948|0.488
71767420|NCT00492063|143036615|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.87|||||TWO_SIDED|95.0|0.74|1.02||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.||1.02|0.74|
71828283|NCT00549848|143161061|SUPERIORITY|||||||0.778|||||||Cochran-Mantel-Haenszel|||||||0.778
71886929|NCT01665144|143294270|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.46|0.91|||Cox proportional hazard model|||Rapidly evolving patients||0.91|0.46|
71767421|NCT00492063|143036615|NON_INFERIORITY_OR_EQUIVALENCE|The value of GMR ratio of cTIV to TIV is \>0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.27|||||TWO_SIDED|95.0|1.11|1.4||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.||1.4|1.11|
71714901|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.284||||0.954|TWO_SIDED|95.0|-9.998|9.431||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL Quality of Life Module (Work) at Week 12.|Mixed Model for Repeated Measures|||QoL (Work) - Week 12||9.431|-9.998|0.954
71714902|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEl module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.049||||0.99|TWO_SIDED|95.0|-7.658|7.559||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 4.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 4||7.559|-7.658|0.99
71714903|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM)adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|1.976||||0.582|TWO_SIDED|95.0|-5.065|9.017||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Treatment Satisfaction \& Bother module (Satisfaction with Treatment Effectiveness) at Week 12.|Mixed Model for Repeated Measures|||TS (Treatment - in general) - Week 12||9.017|-5.065|0.582
71714904|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|5.232||||0.125|TWO_SIDED|95.0|-1.457|11.922||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 4.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 4||11.922|-1.457|0.125
71714905|NCT05136170|142945555|SUPERIORITY|"Changes from baseline in each IDEEL modules scale score was analyzed using a mixed model for repeated measures (MMRM) adjusting by gender, age class, IDEEL module baseline value, treatment, visit and treatment by visit interaction. Subject was considered as a random effect. The covariance matrix used was unstructured. Comparisons vs vehicle TID were provided using least square means at each visit and overall."|LS means difference|-0.156||||0.964|TWO_SIDED|95.0|-6.912|6.6||P-value of LS means difference between treatments from the MMRM on change from baseline in IDEEL DE Symptom Bother Module at Week 12.|Mixed Model for Repeated Measures|||Symptom - Bother - Week 12||6.6|-6.912|0.964
71714906|NCT05136170|142945556|SUPERIORITY||LS means difference|0.795||||0.102|TWO_SIDED|95.0|-0.157|1.748||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 4.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 4 was reported."||1.748|-0.157|0.102
71714907|NCT05136170|142945556|SUPERIORITY||LS means difference|-0.051||||0.923|TWO_SIDED|95.0|-1.094|0.991||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 8.|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 8 was reported."||0.991|-1.094|0.923
71714908|NCT05136170|142945556|SUPERIORITY||LS means difference|0.136||||0.787|TWO_SIDED|95.0|-0.849|1.12||P-value of LS means difference between treatments from the MMRM on change from baseline at Week 12|Mixed Model for Repeated Measures|||"Analysis was based on MMRM with Multiple Imputation under missing not at random using retrieve dropouts with change from baseline in TFBUT at each timepoint adjusting by gender, age class, TFBUT scale baseline value, treatment, visit, and treatment by visit interaction. Patient was considered as a random effect and the covariance matrix used was unstructured.~Herein analysis for Week 12 was reported."||1.12|-0.849|0.787
71767422|NCT01143701|143036619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54|||<|0.05|TWO_SIDED|95.0|-5.89|-1.19|||Mixed Models Analysis|||Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||-1.19|-5.89|<.05
71767423|NCT01143701|143036620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|||<|0.05|TWO_SIDED|95.0|-4.71|1.75|||Mixed Models Analysis|||An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.||1.75|-4.71|<0.05
71767424|NCT00576420|143036705|SUPERIORITY_OR_OTHER|||||||0.1564||90.0|||||Likelihood ratio chi-square test|||||||0.1564
71767425|NCT00576420|143036707|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Likelihood ratio chi-square test|||||||0.060
71767426|NCT00576420|143036707|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Likelihood ratio chi-square test|||||||0.005
71767427|NCT00576420|143036708|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||Likelihood ratio chi-square test|||||||0.123
71661103|NCT03589768|142835859|SUPERIORITY||Ratio|4.7|||<|0.0001|TWO_SIDED|95.0|3.3|6.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|6.6|3.3|<0.0001
71767428|NCT00576420|143036708|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Likelihood ratio chi-square test|||||||0.026
71767429|NCT00576420|143036709|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Likelihood ratio chi-square test|||||||0.929
71767430|NCT00576420|143036709|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Likelihood ratio chi-square test|||||||0.228
71767431|NCT00576420|143036711|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Likelihood ratio chi-square test|||||||0.234
71767432|NCT00576420|143036711|SUPERIORITY_OR_OTHER|||||||0.955||95.0|||||Likelihood ratio chi-square test|||||||0.955
71767433|NCT00576420|143036712|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||Likelihood ratio chi-square test|||||||0.106
71767434|NCT00576420|143036712|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Likelihood ratio chi-square test|||||||0.243
71767435|NCT00576420|143036712|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
71767436|NCT00576420|143036713|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Likelihood ratio chi-square test|||||||0.257
71767437|NCT00576420|143036713|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||Likelihood ratio chi-square test|||||||0.096
71828284|NCT03262935|143161081|SUPERIORITY||Hazard Ratio (HR)|0.6401|||=|0.002|TWO_SIDED|95.0|0.4885|0.8389||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of PFS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||0.8389|0.4885|=0.002
71828285|NCT03262935|143161082|SUPERIORITY||Hazard Ratio (HR)|0.868|||=|0.236|TWO_SIDED|95.0|0.676|1.1145||P-value from stratified log-rank test for Kaplan-Meier estimate of median OS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the hazard ratio of OS, along with 95% CIs. Stratification factors assigned at randomization were world region (Europe, Singapore, and North America), number of prior treatment lines for locally advanced or metastatic breast cancer (excluding hormone therapy) (1 to 2, \>2), and prior treatment with pertuzumab (yes, no).||1.1145|0.676|=0.236
71828286|NCT03262935|143161083|SUPERIORITY||||||=|0.732||||||P-value from Cochran-Mantel-Haenszel test including the randomization stratification factors.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel test (strata based on the baseline stratification factors) was used to compare the two treatment groups with respect to the ORR at two-sided 5% level of significance.||||=0.732
71886930|NCT01665144|143294270|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.69|1.09|||Cox proportional hazard model|||Not rapidly evolving patients||1.09|0.69|
71886931|NCT01665144|143294271|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.65|0.99|||Cox proportional hazard model|||With moderate or severe course of disease||0.99|0.65|
71767438|NCT00576420|143036713|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Likelihood ratio chi-square test|||||||0.127
71767439|NCT01340872|143036736|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
71767440|NCT01340872|143036740|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
71767441|NCT01340872|143036741|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43||||ANCOVA|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|||1.43|< 0.0001
71767442|NCT01340872|143036752|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
71886932|NCT01665144|143294271|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||Cox proportional hazard model|||Without moderate or severe course of disease||1.13|0.47|
71767443|NCT01340872|143036753|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
71767444|NCT01502332|143036762|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71767445|NCT01502332|143036763|SUPERIORITY_OR_OTHER|||||||0.014|||||||Log Rank|||||||0.014
71767446|NCT01502332|143036764|SUPERIORITY_OR_OTHER|||||||0.037|||||||Log Rank|||||||0.037
71767447|NCT01502332|143036766|SUPERIORITY_OR_OTHER|||||||0.267|||||||Regression, Logistic|||||||0.267
71767448|NCT03603509|143036783|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: HAI Day 28 - HAI Day 0 for Fluad = HAI Day 28 - HAI Day 0 for Fluzone Alternative Hypothesis: HAI Day 28 - HAI Day 0 for Fluad NE HAI Day 28 - HAI Day 0 for Fluzone||||0.062
71767449|NCT03603509|143036792|SUPERIORITY|null hypothesis: CMV Fluad sample index = CMV Fluzone sample index at Baseline alternate hypothesis: CMV Fluad sample index not equal to CMV Fluzone sample index at Baseline||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71767450|NCT02656680|143036797|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U Test||||0.72
71767451|NCT02656680|143036798|SUPERIORITY|||||||0.31|||||||Chi-squared|||Chi square test comparing proportion retained in each condition.||||0.31
71767452|NCT02656680|143036799|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71828287|NCT03262935|143161084|SUPERIORITY||Hazard Ratio (HR)|0.5995|||<|0.001|TWO_SIDED|95.0|0.4666|0.7703||P-value from stratified log-rank test for median estimate of PFS: stratified according to the randomization stratification factors.|Log Rank|||A stratified Cox regression analysis was used to estimate the HR of PFS, along with the 95% CI. The treatment groups were compared using the 2-sided stratified log-rank test.||0.7703|0.4666|<0.001
71828288|NCT03262935|143161085|SUPERIORITY|||||||0.473|||||||MMRM|||The change from baseline in the global health status/QoL scale transformed score was analyzed using a mixed model repeated measurement (MMRM) approach.||||0.473
71828289|NCT01811706|143161086|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of T25FW between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
71828290|NCT01811706|143161087|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of SARA score between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
71828291|NCT01811706|143161088|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of Stride Length on BAG between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).||||>0.05
71828292|NCT01256034|143161179|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
71828293|NCT01596504|143161189|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-6.01|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|ONE_SIDED|95.0|-7.77|||p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025:no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1.2 mg|Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-7.77|<0.0001
71886933|NCT01913483|143294280|SUPERIORITY|||||||0.9458||||||The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.|Chi-squared|||Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O'Brien-Fleming alpha spending function.||||0.9458
71886934|NCT00915343|143294287|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862||Comparison of log S-cortisol AUC between OD and TID regimens was adjusted for both period effect and subject effect using generalized linear model (GLM) in statistical analysis system (SAS).|ANOVA||The quotient was defined as AUC0-24h for OD treatment divided by AUC0-24h for TID treatment.|||0.862|0.753|<0.0001
71886935|NCT00915343|143294288|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-111.989|||<|0.0001|TWO_SIDED|95.0|-133.98|89.999|||Fisher's non-parametric permutation test|||||89.999|-133.980|<0.0001
71886936|NCT00915343|143294289|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|110.417||||0.0357|TWO_SIDED|95.0|16.755|204.078|||Fisher's non-parametric permutation test|||||204.078|16.755|0.0357
71886937|NCT00915343|143294290|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-38.076|||<|0.0001|TWO_SIDED|95.0|-50.276|25.876|||Fisher's non-parametric permutation test|||||25.876|-50.276|<0.0001
71886938|NCT00915343|143294291|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-65.782||||0.0033|TWO_SIDED|95.0|-109.201|22.362|||Fisher's non-parametric permutation test|||||22.362|-109.201|0.0033
71886939|NCT00915343|143294292|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-148.015|||<|0.0001|TWO_SIDED|95.0|-189.469|-106.561|||Fisher's non-parametric permutation test|||||-106.561|-189.469|<0.0001
71714909|NCT05136170|142945557|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||<0.001
71714910|NCT05136170|142945557|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||<0.001
71714911|NCT05136170|142945557|SUPERIORITY|||||||0.014||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.014
71714912|NCT05136170|142945557|SUPERIORITY|||||||0.095||||||Not statistically significant result. p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.095
71714913|NCT05136170|142945558|SUPERIORITY|||||||0.02||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.02
71714914|NCT05136170|142945558|SUPERIORITY|||||||0.328||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 8 (Visit 4) was reported.||||0.328
71714915|NCT05136170|142945558|SUPERIORITY|||||||0.287||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 12 (Visit 5) was reported.||||0.287
71714916|NCT05136170|142945558|SUPERIORITY|||||||0.777||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 16 (Visit 6) was reported.||||0.777
71714917|NCT05136170|142945559|SUPERIORITY|||||||0.126||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Week 4 (Visit 3) was reported.||||0.126
71828294|NCT01596504|143161189|SUPERIORITY_OR_OTHER||LS mean difference|-4.61|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|ONE_SIDED|95.0|-6.34|||p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2\>0.05 \& p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2\>0.05 \& p1\>0.025: no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1. 8 mg|Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 \[\<8% and \>=8%\], use of metformin at screening \[yes or no\]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|||-6.34|<0.0001
71714918|NCT05136170|142945559|SUPERIORITY|||||||0.968||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 8 (Visit 4) was reported.||||0.968
71714919|NCT05136170|142945559|SUPERIORITY|||||||0.613||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 12 (Visit 5) was reported.||||0.613
71714920|NCT05136170|142945559|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Week 16 (Visit 6) was reported.||||0.805
71714921|NCT05136170|142945560|SUPERIORITY|||||||0.543||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 8 (Visit 4) was reported.||||0.543
71714922|NCT05136170|142945560|SUPERIORITY|||||||0.677||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Global score - Week 12 (Visit 5) was reported.||||0.677
71714923|NCT05136170|142945560|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global score - Week 16 (Visit 6) was reported.||||0.914
71767453|NCT02656680|143036800|SUPERIORITY|||||||0.218|||||||ANOVA|||We compared mean percent weight loss from baseline across groups with a one-way ANOVA. One participant became pregnant and thus removed from the analysis. This analysis is exploratory given that this pilot study was not powered to detect weight loss differences between groups.||||0.218
71767454|NCT02656680|143036801|SUPERIORITY|||||||0.421|||||||ANOVA|||||||0.421
71767455|NCT04966910|143036802|SUPERIORITY|||||||0.036||||||This p-value applies to the time x condition interaction variable in a repeated-measure ANOVA for client data.|ANOVA|||Repeated measures ANOVA including a time x condition interaction term to test for differences in slopes by condition for client data.||||0.036
71767456|NCT04966910|143036803|SUPERIORITY|||||||0.226||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA.|ANOVA|||||||.226
71714924|NCT05136170|142945560|SUPERIORITY|||||||0.874||||||p-value corresponds to two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 8 (Visit 4) was reported.||||0.874
71767457|NCT04966910|143036804|SUPERIORITY|||||||0.674||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.674
71767458|NCT04966910|143036805|SUPERIORITY|||||||0.317||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.317
71767459|NCT04966910|143036806|SUPERIORITY|||||||0.741||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.741
71767460|NCT04966910|143036807|SUPERIORITY|||||||0.737||||||This p-value refers to a time x condition interaction term in a repeated measures ANOVA to test for differences in slopes over time.|ANOVA|||||||.737
71714925|NCT05136170|142945560|SUPERIORITY|||||||0.945||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 12 (Visit 5) was reported.||||0.945
71714926|NCT05136170|142945560|SUPERIORITY|||||||0.727||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 16 (Visit 6) was reported.||||0.727
71714927|NCT05136170|142945560|SUPERIORITY|||||||0.342||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 8 (Visit 4) was reported.||||0.342
71714928|NCT05136170|142945560|SUPERIORITY|||||||0.821||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 12 (Visit 5) was reported.||||0.821
71714929|NCT05136170|142945560|SUPERIORITY|||||||0.926||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 16 (Visit 6) was reported.||||0.926
71714930|NCT05136170|142945561|SUPERIORITY|||||||0.0344||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) - Week 4 (Visit 3) was reported.||||0.0344
71767461|NCT00789074|143036817|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
71767462|NCT00789074|143036818|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
71767463|NCT00789074|143036819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||F=16.60|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.001
71767464|NCT00789074|143036820|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||F=2.92|ANOVA|Changes were compared using repeated measures analysis of variance||||||<0.04
71767465|NCT00789074|143036821|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.02
71714931|NCT05136170|142945561|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% - Week 4 (Visit 3) was reported.||||1
71828295|NCT01901276|143161206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||t-test, 2 sided|||Within-individual differences in Shannon indices were tested using paired t tests (normally distributed data).||||0.71
71714932|NCT05136170|142945561|SUPERIORITY|||||||0.0235||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 - Week 4 (Visit 3) was reported.||||0.0235
71714933|NCT05136170|142945562|SUPERIORITY|||||||0.888||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 4 (Visit 3) was reported.||||0.888
71714934|NCT05136170|142945562|SUPERIORITY|||||||0.651||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Impact on Daily Activities) - Week 8 (Visit 4) was reported.||||0.651
71714935|NCT05136170|142945562|SUPERIORITY|||||||0.267||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 12 (Visit 5) was reported.||||0.267
71714936|NCT05136170|142945562|SUPERIORITY|||||||0.459||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Daily Activities) - Week 16 (Visit 6) was reported.||||0.459
71714937|NCT05136170|142945562|SUPERIORITY|||||||0.192||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 4 was reported.||||0.192
71714938|NCT05136170|142945562|SUPERIORITY|||||||0.568||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 8 was reported.||||0.568
71828296|NCT04347954|143161207|OTHER||Mean Difference (Net)|-0.349|||||TWO_SIDED|95.0|-1.584|0.886||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.886|-1.584|
71828297|NCT04347954|143161207|OTHER||Mean Difference (Net)|-1.059|||||TWO_SIDED|95.0|-2.318|0.201||||||Analysis of change in mean Ct values incorporating baseline, hour 1, and day 3 values.||0.201|-2.318|
71714939|NCT05136170|142945562|SUPERIORITY|||||||0.871||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 12 was reported.||||0.871
71714940|NCT05136170|142945562|SUPERIORITY|||||||0.85||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for QoL (Emotional Impact due to Dry Eye) - Week 16 was reported.||||0.85
71714941|NCT05136170|142945562|SUPERIORITY|||||||0.364||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 4 was reported.||||0.364
71714942|NCT05136170|142945562|SUPERIORITY|||||||0.646||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 8 was reported.||||0.646
71714943|NCT05136170|142945562|SUPERIORITY|||||||0.739||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 12 was reported.||||0.739
71714944|NCT05136170|142945562|SUPERIORITY|||||||0.664||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for QoL (Impact on Work due to Dry Eye) - Week 16 was reported.||||0.664
71714945|NCT05136170|142945562|SUPERIORITY|||||||0.846||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 4 was reported.||||0.846
71714946|NCT05136170|142945562|SUPERIORITY|||||||0.248||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 8 was reported.||||0.248
71714947|NCT05136170|142945562|SUPERIORITY|||||||0.341||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 12 was reported.||||0.341
71714948|NCT05136170|142945562|SUPERIORITY|||||||0.413||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients|t-test, 2 sided|||Herein analysis for TS (Satisfaction with Effectiveness) - Week 16 was reported.||||0.413
71767466|NCT00789074|143036822|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|Changes were compared using repeated measures analysis of variance||||||0.97
71828298|NCT00761930|143161218|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71828299|NCT00761930|143161219|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71714949|NCT05136170|142945562|SUPERIORITY|||||||0.927||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 4 was reported.||||0.927
71767467|NCT02564432|143036830|EQUIVALENCE|This is not a randomized clinical trial but is an observational study, each patient's thigh skin site served as the control.|Base mean abundance|0.03|||<|0.05|TWO_SIDED|||||The reported p-value was calculated.|Unweighted UniFrac (qualitative)|Both weighted and unweighted UniFrac were calculated; weighted UniFrac is calculated to be p = 0.398 while unweighted UniFrac was P\<0.03|Differential abundance of Staphylococcus aureus in the stoma calculated by Log2 fold change (y-axis) versus base mean abundance (x-axis)|Sample similarity was calculated using the statistical comparisons of community composition.||||<0.05
71767468|NCT02564432|143036830|OTHER|"In this study, dissimilarities between the stomal and healthy thigh skins were tested.~Observational study. Used only for visualizing trends in the data."|PERMANOVA|0.001|||<|0.005|TWO_SIDED|||||Each stomal community type was distinguished by both its diversity and taxonomic composition|Bray-Curtis dissimilarities|Nonmetric multidimensional scaling (NMDS) of Bray-Curtis dissimilarities|||Loess Regression was used to visualize temporal trends in the Shannnon Diversity and relative abundance of microbes (Staphylococcus, Streptococcus, Corynebacterium, and obligate anaerobes).|||<0.005
71767469|NCT00730028|143036832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7688|TWO_SIDED|95.0|-7.6|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||5.1|-7.6|0.7688
71767470|NCT00730028|143036832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-5.4|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.1|-5.4|1.0000
71767471|NCT00730028|143036832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-19.2|-5.6||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.6|-19.2|<0.0001
71767472|NCT00730028|143036832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.0002|TWO_SIDED|95.0|-19.1|-5.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.4|-19.1|0.0002
71767473|NCT00730028|143036835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.52|TWO_SIDED|95.0|-10.2|4.9||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.||4.9|-10.2|0.5200
71767474|NCT00730028|143036835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.7324|TWO_SIDED|95.0|-8.4|5.7||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||5.7|-8.4|0.7324
71767475|NCT00730028|143036835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2||||0.0001|TWO_SIDED|95.0|-22.0|-6.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-6.4|-22.0|0.0001
71767476|NCT00730028|143036835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9||||0.0008|TWO_SIDED|95.0|-20.8|-5.0||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.||-5.0|-20.8|0.0008
71767477|NCT00730028|143036836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7707|TWO_SIDED|95.0|-7.1|5.3||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||5.3|-7.1|0.7707
71767478|NCT00730028|143036836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.2141|TWO_SIDED|95.0|-2.0|8.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.5|-2.0|0.2141
71767479|NCT00730028|143036836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0593|TWO_SIDED|95.0|-12.4|0.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.5|-12.4|0.0593
71714950|NCT05136170|142945562|SUPERIORITY|||||||0.914||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 8 was reported.||||0.914
71828300|NCT00761930|143161220|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71828301|NCT03257813|143161221|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.013||||||Baseline|t-test, 2 sided|||||||0.013
71714951|NCT05136170|142945562|SUPERIORITY|||||||0.564||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 12 was reported.||||0.564
71714952|NCT05136170|142945562|SUPERIORITY|||||||0.489||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for TS (Treatment Bother/Inconvenience) - Week 16 was reported.||||0.489
71714953|NCT05136170|142945562|SUPERIORITY|||||||0.082||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 4||||0.082
71714954|NCT05136170|142945562|SUPERIORITY|||||||0.848||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 8 was reported.||||0.848
71714955|NCT05136170|142945562|SUPERIORITY|||||||0.805||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Symptom-Bother - Week 12 was reported.||||0.805
71714956|NCT05136170|142945562|SUPERIORITY|||||||0.833||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Symptom-Bother - Week 16 was reported.||||0.833
71714957|NCT05136170|142945565|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||<0.001
71714958|NCT05136170|142945566|SUPERIORITY|||||||0.046||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.046
71714959|NCT05136170|142945567|SUPERIORITY|||||||0.34||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||||||0.34
71714960|NCT05136170|142945568|SUPERIORITY|||||||0.017||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 2 was reported||||0.017
71714961|NCT05136170|142945568|SUPERIORITY|||||||0.339||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Global Score - Week 4 was reported||||0.339
71714962|NCT05136170|142945568|SUPERIORITY|||||||0.004||||||p-value corresponds to a two sample (independent group) t-test of the comparisons between Cenegermin and Vehicle in all patients.|t-test, 2 sided|||Herein analysis for Severity - Week 2 was reported.||||0.004
71714963|NCT05136170|142945568|SUPERIORITY|||||||0.292||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Severity - Week 4 was reported.||||0.292
71767480|NCT00730028|143036836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0017|TWO_SIDED|95.0|-15.3|-3.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.1|-15.3|0.0017
71767481|NCT00730028|143036837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1381|TWO_SIDED|95.0|-13.1|1.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.8|-13.1|0.1381
71767482|NCT00730028|143036837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.8302|TWO_SIDED|95.0|-6.4|8.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||8.2|-6.4|0.8302
71828302|NCT03257813|143161221|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.001||||||CrossOver|t-test, 2 sided|||||||0.001
71714964|NCT05136170|142945568|SUPERIORITY|||||||0.09||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 2 was reported.||||0.09
71714965|NCT05136170|142945568|SUPERIORITY|||||||0.54||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all patients.|Wilcoxon (Mann-Whitney)|||Herein analysis for Frequency - Week 4 was reported.||||0.54
71714966|NCT05136170|142945569|SUPERIORITY|||||||0.0064||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores (SANDE global score) was reported.||||0.0064
71714967|NCT05136170|142945569|SUPERIORITY|||||||1||||||p-value corresponds to a Fisher's exact test of the comparisons between Cenegermin and Vehicle in all patients.|Fisher Exact|||Herein analysis for NEI score \>= 50% was reported.||||1
71714968|NCT05136170|142945569|SUPERIORITY|||||||0.0034||||||p-value corresponds to Chi-square test of the comparisons between Cenegermin and Vehicle in all patients.|Chi-squared|||Herein analysis for Worsening in symptom scores and/or NEI score \>= 50 was reported.||||0.0034
71714969|NCT05136170|142945570|SUPERIORITY||||||<|0.001||||||p-value corresponds to a non-parametric Mann-Whitney-Wilcoxon (Wilcoxon rank sum) test of the comparisons between Cenegermin and Vehicle in all participants.|Wilcoxon (Mann-Whitney)|||||||<0.001
71714970|NCT01788943|142945572|OTHER|||||||0.037|||||||ANOVA|||||||0.037
71714971|NCT01788943|142945573|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71714972|NCT04846231|142945620|SUPERIORITY||Mean Difference (Net)|35.22|||<|0.001|TWO_SIDED|95.0|29.13|41.32|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05. This belongs to the primary endpoint.||41.32|29.13|<0.001
71828303|NCT03257813|143161221|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.05||||||Final Visit|t-test, 2 sided|||||||0.050
71828304|NCT03257813|143161222|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.823||||||Baseline|t-test, 2 sided|||||||0.823
71828305|NCT03257813|143161222|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.507||||||CrossOver|t-test, 2 sided|||||||0.507
71714973|NCT04846231|142945620|SUPERIORITY||Mean Difference (Net)|34.43|||<|0.001|TWO_SIDED|95.0|28.28|40.58|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||40.58|28.28|<0.001
71714974|NCT04846231|142945620|SUPERIORITY||Mean Difference (Net)|38.27|||<|0.001|TWO_SIDED|95.0|32.2|44.34|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||44.34|32.20|<0.001
71714975|NCT04846231|142945620|SUPERIORITY||Mean Difference (Net)|42.98|||<|0.001|TWO_SIDED|95.0|37.02|48.95|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||48.95|37.02|<0.001
71714976|NCT04846231|142945620|SUPERIORITY||Mean Difference (Final Values)|36.57|||<|0.001|TWO_SIDED|95.0|30.61|42.54|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||42.54|30.61|<0.001
71714977|NCT04846231|142945620|SUPERIORITY||Mean Difference (Net)|33.49|||<|0.001|TWO_SIDED|95.0|27.42|39.55|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||39.55|27.42|<0.001
71714978|NCT04846231|142945620|SUPERIORITY||Mean Difference (Net)|31.31|||<|0.001|TWO_SIDED|95.0|25.16|37.47|||ANCOVA|||To control the overall alpha of the study, the primary endpoint will be evaluated hierarchically. Each comparison to rosuvastatin will use an alpha of 0.05.||37.47|25.16|<0.001
71714979|NCT04846231|142945622|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71767483|NCT00730028|143036837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0838|TWO_SIDED|95.0|-14.3|1.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||1.1|-14.3|0.0838
71828306|NCT03257813|143161222|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.495||||||Final Visit|t-test, 2 sided|||||||0.495
71828307|NCT03257813|143161223|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.085|||||||Chi-squared|||||||0.085
71828308|NCT03257813|143161224|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.001||||||Baseline|Fisher Exact|||||||0.001
71714980|NCT01448616|142945631|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.86||||0.086|TWO_SIDED|95.0|0.71|1.01||ITT|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.01|0.71|0.086
71714981|NCT01448616|142945631|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.94||||0.54|TWO_SIDED|95.0|0.75|1.16||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)|Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.16|0.75|0.54
71714982|NCT01448616|142945631|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLME|||For intent to treat analysis, difference between lead-in and treatment phase (within arm comparison)||1.22|0.67|0.47
71714983|NCT01448616|142945632|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.16||||0.18|TWO_SIDED|95.0|-0.4|0.07|||Linear Mixed Effects Model|||Intent to treat analysis||0.07|-0.40|0.18
71714984|NCT01448616|142945632|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|-0.5||||0.008|TWO_SIDED|95.0|-0.86|-0.13|||Linear Mixed Effects Model|||Intent to treat analysis||-0.13|-0.86|0.008
71714985|NCT01448616|142945632|SUPERIORITY_OR_OTHER_LEGACY||Change in log copies|0.16||||0.45|TWO_SIDED|95.0|-0.27|0.6|||Linear Mixed Effects Model|||Intent to treat analysis||0.60|-0.27|0.45
71714986|NCT01448616|142945633|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.9|TWO_SIDED|95.0|0.7|1.37|||Poisson GLME|||Intent to treat analysis||1.37|0.70|0.90
71714987|NCT01448616|142945633|SUPERIORITY||Risk Ratio (RR)|0.8||||0.25|TWO_SIDED|95.0|0.54|1.18|||Poisson GLM|||Intent to treat||1.18|0.54|0.25
71714988|NCT01448616|142945633|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.57|1.57|||Poisson GLM|||||1.57|0.57|0.82
71714989|NCT01448616|142945634|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.01|TWO_SIDED|95.0|0.59|0.92|||Poisson GLME|||Intent to Treat||0.92|0.59|0.010
71714990|NCT01448616|142945634|SUPERIORITY||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|0.9|1.76|||Poisson GLM|||||1.76|0.9|0.09
71714991|NCT01448616|142945634|SUPERIORITY||Risk Ratio (RR)|0.9||||0.47|TWO_SIDED|95.0|0.67|1.22|||Poisson GLM|||Intent to treat analysis||1.22|0.67|0.47
71714992|NCT01991860|142945635|SUPERIORITY|||||||0.033||||||2-sided|Chi-squared, Corrected|Yates's continuity correction||||||0.033
71714993|NCT01991860|142945636|SUPERIORITY|||||||0.16|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.16
71714994|NCT01991860|142945637|SUPERIORITY|||||||0.68|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.68
71714995|NCT01991860|142945638|SUPERIORITY|||||||0.026|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.026
71828309|NCT03257813|143161224|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.148||||||CrossOver|Fisher Exact|||||||0.148
71828310|NCT03257813|143161224|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.212||||||Final Visit|Fisher Exact|||||||0.212
71828311|NCT03257813|143161225|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||Baseline|Chi-squared, Corrected|||||||0.497
71714996|NCT01991860|142945639|SUPERIORITY|||||||0.086|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.086
71714997|NCT01991860|142945640|SUPERIORITY|||||||0.074|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.074
71714998|NCT01991860|142945641|SUPERIORITY|||||||0.15|||||||Chi-squared, Corrected|Yates's continuity correction||||||0.15
71714999|NCT00485173|142945649|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71715000|NCT00485173|142945649|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
71715001|NCT00485173|142945650|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71715002|NCT00485173|142945650|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.002
71828312|NCT03257813|143161225|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||CrossOver|Chi-squared, Corrected|||||||0.497
71661104|NCT03589768|142835859|SUPERIORITY||Ratio|3.3|||<|0.0001|TWO_SIDED|95.0|2.1|5.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|5.2|2.1|<0.0001
71661105|NCT03589768|142835860|SUPERIORITY||Ratio|1.1||||0.7039|TWO_SIDED|95.0|0.8|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.8|0.7039
71661106|NCT03589768|142835860|SUPERIORITY||Ratio|18.5|||<|0.0001|TWO_SIDED|95.0|14.0|24.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|24.3|14.0|<0.0001
71661107|NCT03589768|142835860|SUPERIORITY||Ratio|10.5|||<|0.0001|TWO_SIDED|95.0|8.1|13.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|13.7|8.1|<0.0001
71661108|NCT03589768|142835860|SUPERIORITY||Ratio|7.4|||<|0.0001|TWO_SIDED|95.0|5.0|11.1|||t-test, 2 sided|Difference in log values back transformed into ratio.||Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|11.1|5.0|<0.0001
71661109|NCT03589768|142835861|SUPERIORITY||Ratio|1.2||||0.2897|TWO_SIDED|95.0|0.8|1.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.8|0.8|0.2897
71661110|NCT03589768|142835861|SUPERIORITY||Ratio|54.2|||<|0.0001|TWO_SIDED|95.0|35.6|82.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|82.4|35.6|<0.0001
71661111|NCT03589768|142835861|SUPERIORITY||Ratio|32.0|||<|0.0001|TWO_SIDED|95.0|20.6|49.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|49.7|20.6|<0.0001
71661112|NCT03589768|142835861|SUPERIORITY||Ratio|18.9|||<|0.0001|TWO_SIDED|95.0|10.4|34.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|34.2|10.4|<0.0001
71661113|NCT03589768|142835862|SUPERIORITY||Ratio|1.0||||0.837|TWO_SIDED|95.0|0.6|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.6|0.8370
71661114|NCT03589768|142835862|SUPERIORITY||Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|<0.0001
71661115|NCT03589768|142835862|SUPERIORITY||Ratio|0.7||||0.005|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0050
71661116|NCT03589768|142835862|SUPERIORITY||Ratio|0.8||||0.0689|TWO_SIDED|95.0|0.6|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.6|0.0689
71661117|NCT03589768|142835863|SUPERIORITY||Ratio|1.0||||0.8361|TWO_SIDED|95.0|0.7|1.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for pre-vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.6|0.7|0.8361
71661118|NCT03589768|142835863|SUPERIORITY||Ratio|0.9||||0.5136|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after vaccination time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5136
71715003|NCT00485173|142945651|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.002
71715004|NCT00485173|142945652|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71715005|NCT00485173|142945652|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.011
71715006|NCT00485173|142945653|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.063
71828313|NCT03257813|143161225|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0||||||"Final Visit~No statistic will be calculated because Final Chemosis is a constant"|Chi-squared, Corrected|||||||0
71828314|NCT03257813|143161226|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||baseline|Chi-squared|||||||1.000
71828315|NCT03257813|143161226|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.391||||||Cross Over|Chi-squared|||||||0.391
71828316|NCT03257813|143161226|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.534||||||Final Visit|Chi-squared|||||||0.534
71828317|NCT03257813|143161227|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.023||||||Baseline|Chi-squared, Corrected|||||||0.023
71828318|NCT03257813|143161227|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
71828319|NCT03257813|143161227|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.793||||||Final Visit|Chi-squared|||||||0.793
71661119|NCT03589768|142835863|SUPERIORITY||Ratio|0.9||||0.4237|TWO_SIDED|95.0|0.6|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.6|0.4237
71715007|NCT00485173|142945654|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71715008|NCT00485173|142945654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||<0.001
71828320|NCT03257813|143161228|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.825||||||Baseline|Chi-squared|||||||0.825
71828321|NCT03257813|143161228|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared|||||||1.000
71828322|NCT03257813|143161228|NON_INFERIORITY|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.765|||||||Chi-squared|||||||0.765
71828323|NCT02878330|143161229|SUPERIORITY||Relative Risk Reduction|70.1|||<|0.0001|TWO_SIDED|95.0|52.3|81.2|||Poisson regression|||||81.2|52.3|<0.0001
71661120|NCT03589768|142835863|SUPERIORITY||Ratio|0.7||||0.1607|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months after delivery time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.2|0.4|0.1607
71661121|NCT03589768|142835864|SUPERIORITY||Ratio|13.7|||<|0.0001|TWO_SIDED|95.0|10.2|18.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|18.3|10.2|<0.0001
71715009|NCT00485173|142945655|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.031
71661122|NCT03589768|142835864|SUPERIORITY||Ratio|10.8|||<|0.0001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|14.5|8.0|<0.0001
71661123|NCT03589768|142835864|SUPERIORITY||Ratio|10.2|||<|0.0001|TWO_SIDED|95.0|6.9|15.2|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio. Test compares difference in log values.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|15.2|6.9|<0.0001
71661124|NCT03589768|142835864|SUPERIORITY||Ratio|2.1||||0.0002|TWO_SIDED|95.0|1.4|3.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|3.0|1.4|0.0002
71661125|NCT03589768|142835864|SUPERIORITY||Ratio|1.2||||0.4828|TWO_SIDED|95.0|0.8|1.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.7|0.8|0.4828
71661126|NCT03589768|142835865|SUPERIORITY||Ratio|46.4|||<|0.0001|TWO_SIDED|95.0|26.6|81.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|81.0|26.6|<0.0001
71828324|NCT02878330|143161230|SUPERIORITY||Relative Risk Reduction|78.4||||0.0002|TWO_SIDED|95.0|51.9|90.3|||Poisson regression|||||90.3|51.9|0.0002
71767484|NCT00730028|143036837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.0507|TWO_SIDED|95.0|-15.2|0.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||0.2|-15.2|0.0507
71767485|NCT00730028|143036838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.1505|TWO_SIDED|95.0|-13.3|1.9||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||1.9|-13.3|0.1505
71767486|NCT00730028|143036838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1666|TWO_SIDED|95.0|-10.9|2.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.2|-10.9|0.1666
71767487|NCT00730028|143036838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.0001|TWO_SIDED|95.0|-23.0|-8.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-8.0|-23.0|<0.0001
71828325|NCT02194933|143161240|SUPERIORITY_OR_OTHER|||||||0.3992||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.3992
71828326|NCT02194933|143161241|SUPERIORITY_OR_OTHER|||||||0.0053||||||Test for Baseline vs. Week 6|Mixed Models Analysis|||||||0.0053
71828327|NCT02194933|143161243|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Mixed Models Analysis|||||||0.1559
71828328|NCT02194933|143161243|SUPERIORITY_OR_OTHER|||||||0.6201|||||||Mixed Models Analysis|||||||0.6201
71828329|NCT02194933|143161244|SUPERIORITY_OR_OTHER|||||||0.1642|||||||Mixed Models Analysis|||||||0.1642
71828330|NCT02194933|143161244|SUPERIORITY_OR_OTHER|||||||0.1873|||||||Mixed Models Analysis|||||||0.1873
71828331|NCT02194933|143161247|SUPERIORITY_OR_OTHER|||||||0.2061|||||||Mixed Models Analysis|||||||0.2061
71828332|NCT02194933|143161247|SUPERIORITY_OR_OTHER|||||||0.1778|||||||Mixed Models Analysis|||||||0.1778
71828333|NCT02194933|143161248|SUPERIORITY_OR_OTHER|||||||0.4138|||||||Mixed Models Analysis|||||||0.4138
71656748|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.22|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.01|-0.22|
71828334|NCT02194933|143161248|SUPERIORITY_OR_OTHER|||||||0.3375|||||||Mixed Models Analysis|||||||0.3375
71828335|NCT02194933|143161251|SUPERIORITY_OR_OTHER|||||||0.8437|||||||Mixed Models Analysis|||||||0.8437
71828336|NCT02194933|143161251|SUPERIORITY_OR_OTHER|||||||0.8318|||||||Mixed Models Analysis|||||||0.8318
71828337|NCT02194933|143161252|SUPERIORITY_OR_OTHER|||||||0.6697|||||||Mixed Models Analysis|||||||0.6697
71656749|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.34|||||TWO_SIDED|95.0|-0.44|-0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.23|-0.44|
71656750|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.22|||||TWO_SIDED|95.0|-0.33|-0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.11|-0.33|
71656751|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.16|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.16|
71656752|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.04|0.31|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.31|0.04|
71656753|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.2|||||TWO_SIDED|95.0|0.07|0.34|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.34|0.07|
71828338|NCT02194933|143161252|SUPERIORITY_OR_OTHER|||||||0.8829|||||||Mixed Models Analysis|||||||0.8829
71828339|NCT02194933|143161253|SUPERIORITY_OR_OTHER|||||||0.2301|||||||Mixed Models Analysis|||||||0.2301
71828340|NCT02194933|143161253|SUPERIORITY_OR_OTHER|||||||0.0599|||||||Mixed Models Analysis|||||||0.0599
71828341|NCT02194933|143161254|SUPERIORITY_OR_OTHER|||||||0.1595|||||||Mixed Models Analysis|||||||0.1595
71828342|NCT02194933|143161254|SUPERIORITY_OR_OTHER|||||||0.1211|||||||Mixed Models Analysis|||||||0.1211
71828343|NCT02194933|143161255|SUPERIORITY_OR_OTHER|||||||0.1322|||||||Mixed Models Analysis|||||||0.1322
71715010|NCT00485173|142945656|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.001
71715011|NCT00485173|142945656|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.414
71715012|NCT00485173|142945657|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.030
71715013|NCT00485173|142945658|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71715014|NCT00485173|142945658|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.017
71828344|NCT02194933|143161255|SUPERIORITY_OR_OTHER|||||||0.2113|||||||Mixed Models Analysis|||||||0.2113
71828345|NCT02194933|143161256|SUPERIORITY_OR_OTHER|||||||0.0578|||||||Mixed Models Analysis|||||||0.0578
71828346|NCT02194933|143161256|SUPERIORITY_OR_OTHER|||||||0.0588|||||||Mixed Models Analysis|||||||0.0588
71828347|NCT02194933|143161257|SUPERIORITY_OR_OTHER|||||||0.1666|||||||Mixed Models Analysis|||||||0.1666
71828348|NCT02194933|143161257|SUPERIORITY_OR_OTHER|||||||0.767|||||||Mixed Models Analysis|||||||0.7670
71828349|NCT02194933|143161258|SUPERIORITY_OR_OTHER|||||||0.7178|||||||Mixed Models Analysis|||||||0.7178
71828350|NCT02194933|143161258|SUPERIORITY_OR_OTHER|||||||0.2336|||||||Mixed Models Analysis|||||||0.2336
71828351|NCT02194933|143161259|SUPERIORITY_OR_OTHER|||||||0.6558|||||||Mixed Models Analysis|||||||0.6558
71828352|NCT02194933|143161259|SUPERIORITY_OR_OTHER|||||||0.9058|||||||Mixed Models Analysis|||||||0.9058
71715015|NCT00485173|142945659|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.189
71715016|NCT00485173|142945660|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.||||||0.003||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||0.003
71715017|NCT00485173|142945660|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.466
71715018|NCT00485173|142945661|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.10.|||||<|0.001||95.0||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic|||||||<0.001
71828353|NCT02194933|143161260|SUPERIORITY_OR_OTHER|||||||0.0078|||||||Mixed Models Analysis|||||||0.0078
71828354|NCT02194933|143161260|SUPERIORITY_OR_OTHER|||||||0.4272|||||||Mixed Models Analysis|||||||0.4272
71715019|NCT00485173|142945661|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.||||0.133
71715020|NCT00485173|142945662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
71715021|NCT00485173|142945663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||<0.001
71715022|NCT00485173|142945664|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA|||||||0.341
71715023|NCT00485173|142945665|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.|Regression, Cox|||||||0.479
71715024|NCT00485173|142945666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.|Regression, Logistic|||Statistical analysis at 24 months postoperation.||||<0.001
71828355|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.||1.31|0.81|
71828356|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.8|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3||1.16|0.8|
71828357|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.13|||||TWO_SIDED|95.0|0.92|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4||1.4|0.92|
71828358|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||TWO_SIDED|95.0|0.75|1.21|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5||1.21|0.75|
71828359|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.92|||||TWO_SIDED|95.0|0.73|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B||1.16|0.73|
71886940|NCT00915343|143294293|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-108.306|||<|0.0001|TWO_SIDED|95.0|-140.193|-76.42|||Fisher's non-parametric permutation test|||||-76.420|-140.193|<0.0001
71886941|NCT00915343|143294294|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.27||||0.0214|TWO_SIDED|95.0|0.028|0.512|||Fisher's non-parametric permutation test|||||0.512|0.028|0.0214
71886942|NCT00915343|143294295|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-1.042||||0.0714|TWO_SIDED|95.0|-2.098|0.015|||Fisher's non-parametric permutation test|||||0.015|-2.098|0.0714
71886943|NCT00915343|143294296|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.007||||0.6687|TWO_SIDED|95.0|-0.038|0.024|||Fisher's non-parametric permutation test|||||0.024|-0.038|0.6687
71886944|NCT00915343|143294297|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.049||||0.028|TWO_SIDED|95.0|0.006|0.093|||Fisher's non-parametric permutation test|||||0.093|0.006|0.0280
71886945|NCT00915343|143294298|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|5.509||||0.0003|TWO_SIDED|95.0|0.751|10.268|||Fisher's non-parametric permutation test|||||10.268|0.751|0.0003
71661127|NCT03589768|142835865|SUPERIORITY||Ratio|39.5|||<|0.0001|TWO_SIDED|95.0|24.0|65.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|65.0|24.0|<0.0001
71767488|NCT00730028|143036838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.0046|TWO_SIDED|95.0|-19.0|-3.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-3.2|-19.0|0.0046
71767489|NCT00730028|143036839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.1815|TWO_SIDED|95.0|-13.6|2.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.||2.8|-13.6|0.1815
71886946|NCT00915343|143294299|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-20.533|-7.067|||Fisher's non-parametric permutation test|||||-7.067|-20.533|<0.0001
71886947|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.064||||0.0002|TWO_SIDED|95.0|1.032|1.097|||ANOVA||The quotient was defined as AUC0-4h for OD treatment divided by AUC0-4h for TID treatment.|AUC0-4h||1.097|1.032|0.0002
71886948|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.617|||<|0.0001|TWO_SIDED|95.0|0.563|0.675|||ANOVA||The quotient was defined as AUC4-12h for OD treatment divided by AUC4-12h for TID treatment.|AUC4-12h||0.675|0.563|<0.0001
71886949|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.472|||<|0.0001|TWO_SIDED|95.0|0.424|0.525|||ANOVA||The quotient was defined as AUC6-12h for OD treatment divided by AUC6-12h for TID treatment.|AUC6-12h||0.525|0.424|<0.0001
71886950|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.588||||0.0003|TWO_SIDED|95.0|0.446|0.775|||ANOVA||The quotient was defined as AUC12-24h for OD treatment divided by AUC12-24h for TID treatment.|AUC12-24h||0.775|0.446|0.0003
71886951|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.894|||<|0.0001|TWO_SIDED|95.0|0.856|0.935|||ANOVA||The quotient was defined as AUC0-10h for OD treatment divided by AUC0-10h for TID treatment.|AUC0-10h||0.935|0.856|<0.0001
71886952|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.695|||<|0.0001|TWO_SIDED|95.0|0.632|0.765|||ANOVA||The quotient was defined as AUC4-10h for OD treatment divided by AUC4-10h for TID treatment.|AUC4-10h||0.765|0.632|<0.0001
71886953|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.54|||<|0.0001|TWO_SIDED|95.0|0.482|0.605|||ANOVA||The quotient was defined as AUC6-10h for OD treatment divided by AUC6-10h for TID treatment.|AUC6-10h||0.605|0.482|<0.0001
71886954|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.412|||<|0.0001|TWO_SIDED|95.0|0.338|0.504|||ANOVA||The quotient was defined as AUC10-24h for OD treatment divided by AUC10-24h for TID treatment.|AUC10-24h||0.504|0.338|<0.0001
71886955|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.776|||<|0.0001|TWO_SIDED|95.0|0.714|0.843|||ANOVA||The quotient was defined as AUC(0-inf) for OD treatment divided by AUC(0-inf) for TID treatment.|AUC(0-inf)||0.843|0.714|<0.0001
71886956|NCT00915343|143294300|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.069||||0.877|TWO_SIDED|95.0|0.453|2.521|||ANOVA||The quotient was defined as AUC(24h-inf) for OD treatment divided by AUC(24h-inf) for TID treatment.|AUC(24h-inf)||2.521|0.453|0.8770
71886957|NCT00915343|143294301|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.806|||<|0.0001|TWO_SIDED|95.0|0.753|0.862|||ANOVA||The quotient was defined as AUCtau for OD treatment divided by AUCtau for TID treatment.|||0.862|0.753|<0.0001
71886958|NCT00915343|143294302|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.79|||<|0.0001|TWO_SIDED|95.0|0.734|0.851|||ANOVA||The quotient was defined as AUCtau/dose for OD treatment divided by AUCtau/dose for TID treatment.|||0.851|0.734|<0.0001
71886959|NCT00915343|143294303|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.785|||<|0.0001|TWO_SIDED|95.0|0.741|0.831|||ANOVA||The quotient was defined as AUC0-24h/dose for OD treatment divided by AUC0-24h/dose for TID treatment.|||0.831|0.741|<0.0001
71661128|NCT03589768|142835865|SUPERIORITY||Ratio|10.4|||<|0.0001|TWO_SIDED|95.0|6.1|17.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|17.9|6.1|<0.0001
71661129|NCT03589768|142835865|SUPERIORITY||Ratio|0.6||||0.0746|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0746
71661130|NCT03589768|142835865|SUPERIORITY||Ratio|0.7||||0.1532|TWO_SIDED|95.0|0.5|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.5|0.1532
71715025|NCT00829998|142945693|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|97.4||||||90.0|89.4|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106|89.4|
71715026|NCT00829998|142945694|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
71715027|NCT00829998|142945695|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||107|97.1|
71715028|NCT00834197|142945696|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.59||||||90.0|95.76|105.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||105.65|95.76|
71715029|NCT00834197|142945697|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.17||||||90.0|94.82|101.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.65|94.82|
71715030|NCT00834197|142945698|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|98.25||||||90.0|95.22|101.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.39|95.22|
71715031|NCT04712669|142945699|SUPERIORITY||Mean Difference (Final Values)|57.27|STANDARD_ERROR_OF_MEAN|24.773||0.0208|TWO_SIDED|95.0|8.716|105.824||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||105.824|8.716|0.0208
71715032|NCT04712669|142945699|SUPERIORITY||Mean Difference (Final Values)|58.406|STANDARD_ERROR_OF_MEAN|24.558||0.0174|TWO_SIDED|95.0|10.272|106.54||LSM, SE, CIs for each treatment group; LSM Diff, SE, CIs, and p-value are estimated using an ANCOVA model incl. factors for treatment group and randomization strata with associated baseline value as a covariate.|ANCOVA|H0: The mean change from baseline in PVR at Week 24 is equal between placebo and rodatristat ethyl.||||106.54|10.272|0.0174
71715033|NCT04712669|142945700|SUPERIORITY|||||||0.573||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.573
71767490|NCT00730028|143036839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.1552|TWO_SIDED|95.0|-13.2|2.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||2.1|-13.2|0.1552
71715034|NCT04712669|142945700|SUPERIORITY|||||||0.9911||||||P-value based on ordinal logistic regression with treatment group and randomization stratification strata as factors at alpha=0.05.|Regression, Logistic|H0: The distribution of change from baseline in WHO FC at Week 24 is equal between placebo and rodatristat ethyl.||||||0.9911
71715035|NCT04712669|142945701|SUPERIORITY||Median Difference (Final Values)|-33.61|STANDARD_ERROR_OF_MEAN|18.121||0.0636|TWO_SIDED|95.0|-69.13|1.91||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||1.91|-69.13|0.0636
71715036|NCT04712669|142945701|SUPERIORITY||Median Difference (Final Values)|-19.05|STANDARD_ERROR_OF_MEAN|13.469||0.1573|TWO_SIDED|95.0|-45.45|7.35||p-value (alpha=0.05) is estimated using the aligned rank stratified Wilcoxon test with the randomization stratification factors as strata.|Wilcoxon (Mann-Whitney)|H0: The distribution of change from baseline at Week 24 in 6MWT distance (meters) is equal between placebo and rodatristat ethyl.||||7.35|-45.45|0.1573
71715037|NCT04712669|142945702|SUPERIORITY||Mean Difference (Final Values)|1125.9|STANDARD_ERROR_OF_MEAN|351.28||0.0014|TWO_SIDED|95.0|437.39|1814.39|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1814.39|437.39|0.0014
71715038|NCT04712669|142945702|SUPERIORITY||Mean Difference (Final Values)|866.3|STANDARD_ERROR_OF_MEAN|306.56||0.0047|TWO_SIDED|95.0|265.41|1467.16|||Mixed Models Analysis|H0: The mean change from baseline at Week 24 in NT-proBNP is equal between placebo and rodatristat ethyl.|Estimates from a REML MMRM with baseline covariate, fixed effects, and unstructured covariance.|||1467.16|265.41|0.0047
71715039|NCT03802396|142945703|OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
71715040|NCT03802396|142945704|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.116
71715041|NCT03802396|142945704|OTHER|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.388
71715042|NCT03802396|142945705|OTHER|||||||0.569|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.569
71715043|NCT03802396|142945705|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.047
71715044|NCT03802396|142945706|OTHER|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.498
71715045|NCT03802396|142945706|OTHER|||||||0.745|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.745
71715046|NCT03802396|142945707|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||Baseline to 24 hours||||0.177
71715047|NCT03802396|142945707|OTHER|||||||0.478|||||||Wilcoxon (Mann-Whitney)|||Baseline to 6 weeks||||0.478
71886960|NCT00915343|143294304|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.885|||<|0.0001|TWO_SIDED|95.0|0.844|0.926|||ANOVA||The quotient was defined as AUC0-10h/dose for OD treatment divided by AUC0-10h/dose for TID treatment.|||0.926|0.844|<0.0001
71715048|NCT03802396|142945708|OTHER|||||||0.803|||||||t-test, 2 sided|||||||0.803
71715049|NCT03802396|142945710|OTHER||Risk Ratio (RR)|0.73||||0.286|TWO_SIDED|95.0|0.41|1.3|||Chi-squared|||||1.30|0.41|0.286
71715050|NCT03802396|142945711|OTHER|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
71715051|NCT00163293|142945712|SUPERIORITY_OR_OTHER|||||||0.6625||95.0|||||Log Rank|||||||0.6625
71715052|NCT00163293|142945712|SUPERIORITY_OR_OTHER|||||||0.7303||95.0|||||Log Rank|||||||0.7303
71715053|NCT00163293|142945713|SUPERIORITY_OR_OTHER|||||||0.1291||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.1291
71715054|NCT00163293|142945713|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age \[yrs\] (zero model), treatment and race (Poisson model)||||||0.0145
71715055|NCT00163293|142945715|SUPERIORITY_OR_OTHER|||||||0.4754|||||||Kruskal-Wallis|||||||0.4754
71715056|NCT00163293|142945715|SUPERIORITY_OR_OTHER|||||||0.6844|||||||Kruskal-Wallis|||||||0.6844
71715057|NCT03366454|142945760|OTHER||AUC|0.6692|STANDARD_ERROR_OF_MEAN|0.05322||0.0048|TWO_SIDED|95.0|0.5649|0.7735|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7735|0.5649|0.0048
71715058|NCT03366454|142945760|OTHER||AUC|0.6892|STANDARD_ERROR_OF_MEAN|0.05213||0.0029|TWO_SIDED|95.0|0.587|0.7914|||ROC Curve Analysis|||ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7914|0.5870|0.0029
71715059|NCT03366454|142945761|OTHER||AUC|0.644|STANDARD_ERROR_OF_MEAN|0.05635||0.0233|TWO_SIDED|95.0|0.5335|0.7544|||ROC Curve Analysis||The optimal cutoff value for NLR was determined as 1.335 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.7544|0.5335|0.0233
71828360|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F||1.29|0.89|
71828361|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.79|1.19|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V||1.19|0.79|
71828362|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.18|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14||1.18|0.81|
71715060|NCT03366454|142945762|OTHER||AUC|0.6884|STANDARD_ERROR_OF_MEAN|0.04709||0.0018|TWO_SIDED|95.0|0.5962|0.7807|||ROC Curve Analysis||The optimal cut-off value for CRP was determined as 5.70 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value)||0.7807|0.5962|0.0018
71828363|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.95|||||TWO_SIDED|95.0|0.77|1.16|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C||1.16|0.77|
71886961|NCT00915343|143294305|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|1.053||||0.002|TWO_SIDED|95.0|1.02|1.086|||ANOVA||The quotient was defined as AUC0-4h/dose for OD treatment divided by AUC0-4h/dose for TID treatment.|||1.086|1.020|0.0020
71715061|NCT03366454|142945763|OTHER||AUC|0.7063|STANDARD_ERROR_OF_MEAN|0.04857||0.0007|TWO_SIDED|95.0|0.6111|0.8015|||ROC Curve Analysis||The optimal cutoff value for PCT was determined as 0.141 using the Youden Index.|ROC curve analysis was performed to evaluate outcome. The Area Under the Curve (AUC) was calculated along with a 95% confidence interval and statistical significance (p-value).||0.8015|0.6111|0.0007
71715062|NCT01819272|142945769|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-9.0||||0.067|TWO_SIDED|95.0|-21.0|1.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||1.0|-21.0|0.0670
71715063|NCT01819272|142945769|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-14.0||||0.0057|TWO_SIDED|95.0|-22.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.0|-22.0|0.0057
71715064|NCT01819272|142945769|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.1095|TWO_SIDED|95.0|-25.0|3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||3.0|-25.0|0.1095
71715065|NCT01819272|142945769|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-12.0||||0.0097|TWO_SIDED|95.0|-23.0|-3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-3.0|-23.0|0.0097
71715066|NCT01819272|142945769|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-28.0|||<|0.0001|TWO_SIDED|95.0|-42.0|-17.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-17.0|-42.0|<0.0001
71715067|NCT01819272|142945770|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0226|TWO_SIDED|95.0|-208.0|-16.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-16.00|-208.0|0.0226
71715068|NCT01819272|142945770|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-106.0||||0.0068|TWO_SIDED|95.0|-180.0|-32.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-32.00|-180.0|0.0068
71715069|NCT01819272|142945770|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-152.0||||0.0071|TWO_SIDED|95.0|-252.0|-42.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-42.00|-252.0|0.0071
71715070|NCT01819272|142945770|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-101.0||||0.0405|TWO_SIDED|95.0|-208.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-4.00|-208.0|0.0405
71715071|NCT01819272|142945770|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimation|-224.0|||<|0.0001|TWO_SIDED|95.0|-334.0|-118.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis|||||-118.0|-334.0|<.0001
71715072|NCT01819272|142945771|SUPERIORITY_OR_OTHER||LS Mean|-0.48||||0.01|TWO_SIDED|95.0|-0.85|-0.12|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.12|-0.85|0.0100
71715073|NCT01819272|142945771|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0153|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.09|-0.81|0.0153
71715074|NCT01819272|142945771|SUPERIORITY_OR_OTHER||LS Mean|-0.35||||0.0611|TWO_SIDED|95.0|-0.71|0.02|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||0.02|-0.71|0.0611
71767491|NCT00730028|143036839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||<|0.0001|TWO_SIDED|95.0|-24.0|-7.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-7.8|-24.0|<0.0001
71767492|NCT00730028|143036839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0145|TWO_SIDED|95.0|-18.7|-2.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.||-2.0|-18.7|0.0145
71767493|NCT03860935|143036840|SUPERIORITY||||||<|0.0001|||||||Finkelstein-Schoenfeld Method|||||||<0.0001
71767494|NCT03860935|143036841|SUPERIORITY||Least Squares Mean Difference|39.64|STANDARD_ERROR_OF_MEAN|9.477|<|0.0001|TWO_SIDED|96.0|20.18|59.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||59.10|20.18|<0.0001
71767495|NCT03860935|143036842|SUPERIORITY||Least Squares Mean Difference|9.94|STANDARD_ERROR_OF_MEAN|2.024|<|0.0001|TWO_SIDED|96.0|5.79|14.1|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||14.10|5.79|<0.0001
71828364|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.15|||||TWO_SIDED|95.0|0.95|1.4|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A||1.4|0.95|
71886962|NCT00915343|143294306|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|<0.0001
71715075|NCT01819272|142945771|SUPERIORITY_OR_OTHER||LS Mean|-0.45||||0.0188|TWO_SIDED|95.0|-0.83|-0.08|||ANCOVA|Factor for treatment and baseline HbA1c as acovariate||||-0.08|-0.83|0.0188
71715076|NCT01819272|142945771|SUPERIORITY_OR_OTHER||LS Mean|-0.67||||0.0006|TWO_SIDED|95.0|-1.04|-0.29|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate||||-0.29|-1.04|0.0006
71715077|NCT01246960|142945792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.886|TWO_SIDED|95.0|0.69|1.37|||Stratified Log Rank|||||1.37|0.69|0.886
71715078|NCT01246960|142945793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.712|TWO_SIDED|95.0|0.73|1.58|||Stratified Log Rank|||||1.58|0.73|0.712
71715079|NCT01246960|142945796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.516|TWO_SIDED|95.0|0.59|1.3|||Stratified Log Rank|||||1.30|0.59|0.516
71715080|NCT03376516|142945841|OTHER|||||||0.9593||||||P-Value for patients aged 1-\<6 years (N=5)|ANOVA|||||||0.9593
71715081|NCT03376516|142945841|OTHER|||||||0.3752||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.3752
71715082|NCT03376516|142945841|OTHER|||||||0.8273||||||P-Value for total PK population (N=10)|ANOVA|||||||0.8273
71715083|NCT03376516|142945842|OTHER|P-Value for patients aged 1-\<6 years (N=5)||||||0.8536|||||||ANOVA|||||||0.8536
71715084|NCT03376516|142945842|OTHER|||||||0.9791||||||P-Value for patients aged 6-\<12 years (N=5)|ANOVA|||||||0.9791
71715085|NCT03376516|142945842|OTHER|||||||0.9791||||||P-Value for total PK population (N=10)|ANOVA|||||||0.9791
71715086|NCT03376516|142945844|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|30.85||||||||30.85|0|
71715087|NCT00370292|142945866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71715088|NCT00370292|142945866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71715089|NCT00370292|142945866|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.030
71715090|NCT00370292|142945866|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.166
71715091|NCT00370292|142945866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71715092|NCT00370292|142945866|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71715093|NCT00370292|142945868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71715094|NCT00370292|142945868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71828365|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||TWO_SIDED|95.0|0.84|1.25|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F||1.25|0.84|
71715095|NCT00370292|142945868|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.333
71715096|NCT00370292|142945868|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||0.849
71715097|NCT00370292|142945868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71828366|NCT02045836|143161273|NON_INFERIORITY|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.89|||||TWO_SIDED|95.0|0.7|1.12|||ANCOVA|Ancova model: adjustment for baseline titre - pooled variance|Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F||1.12|0.7|
71828367|NCT02045836|143161274|NON_INFERIORITY|Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5|Adjusted GMC|1.02|||||TWO_SIDED|95.0|0.93|1.11|||ANCOVA|Ancova model: adjustment for baseline concentration and age - pooled variance|Adjusted ratios of GMCs between groups (Control group and Co-Ad group)|Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations||1.11|0.93|
71886963|NCT00915343|143294307|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001|||<|0.0001|TWO_SIDED|95.0|-0.002|-0.001|||Fisher's non-parametric permutation test|||||-0.001|-0.002|<0.0001
71715098|NCT00370292|142945868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance|||||||<0.001
71828368|NCT02498769|143161313|OTHER||Hazard Ratio (HR)|0.69||||0.18|TWO_SIDED|95.0|0.41|1.19|||Regression, Cox|||||1.19|0.41|0.18
71886964|NCT00915343|143294308|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.055||||0.7827|TWO_SIDED|95.0|-0.444|0.334|||Fisher's non-parametric permutation test|||||0.334|-0.444|0.7827
71886965|NCT00915343|143294309|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.001||||0.0015|TWO_SIDED|95.0|-0.001|0.0|||Fisher's non-parametric permutation test|||||-0.000|-0.001|0.0015
71886966|NCT00915343|143294310|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|6.098|||<|0.0001|TWO_SIDED|95.0|2.94|12.646|||ANOVA||The quotient was defined as AUC Extrapolation for OD treatment divided by AUC Extrapolation for TID treatment.|||12.646|2.940|<0.0001
71715099|NCT03545672|142945872|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.001
71715100|NCT03545672|142945873|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71715101|NCT00508521|142945878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.75|STANDARD_ERROR_OF_MEAN|0.47871||0.0001|TWO_SIDED|95.0|-22.27348|-19.22652|||t-test, 2 sided|||This was a feasibility study. Pre and post treatment analysis was performed for the study participants.||-19.22652|-22.27348|.0001
71886967|NCT00915343|143294311|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|33.532||||0.0396|TWO_SIDED|95.0|1.734|65.329|||Fisher's non-parametric permutation test|||||65.329|1.734|0.0396
71886968|NCT00915343|143294312|SUPERIORITY_OR_OTHER_LEGACY||Period-adjusted quotient|0.08||||0.1032|TWO_SIDED|95.0|-0.017|0.177|||Fisher's non-parametric permutation test|||||0.177|-0.017|0.1032
71886969|NCT00915343|143294313|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.078||||0.3767|TWO_SIDED|95.0|-0.25|0.094|||Fisher's test|Fisher's non||Patient||0.094|-0.250|0.3767
71715102|NCT01622296|142945879|SUPERIORITY_OR_OTHER|||||||0.23||||||Significant at p\<0.05|t-test, 2 sided|||Inferior Alveolar nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.23
71715103|NCT01622296|142945879|SUPERIORITY_OR_OTHER|||||||0.57||||||Significant at p\<0.05|t-test, 2 sided|||Long buccal nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)||||0.57
71715104|NCT00372957|142945891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-2.28|-1.93|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||-1.93|-2.28|
71715105|NCT00372957|142945891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||||TWO_SIDED|95.0|-2.33|-1.98|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-1.98|-2.33|
71715106|NCT00372957|142945891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-2.15|-1.82|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||-1.82|-2.15|
71715107|NCT00372957|142945891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12|||||TWO_SIDED|95.0|-2.28|-1.95|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-1.95|-2.28|
71715108|NCT00372957|142945892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.87|||||TWO_SIDED|95.0|2.33|5.41|||Double-delta analysis||he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||5.41|2.33|
71715109|NCT00372957|142945892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|3.7|6.73|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||6.73|3.70|
71715110|NCT00372957|142945892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||||TWO_SIDED|95.0|1.9|4.54|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||4.54|1.90|
71715111|NCT00372957|142945892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.39|||||TWO_SIDED|95.0|3.1|5.68|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.68|3.10|
71715112|NCT00372957|142945893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|||||TWO_SIDED|95.0|-6.0|2.89|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||2.89|-6.00|
71715113|NCT00372957|142945893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|||||TWO_SIDED|95.0|-3.3|5.72|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||5.72|-3.30|
71715114|NCT00372957|142945893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.2|2.5|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||2.50|-5.20|
71715115|NCT00372957|142945893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|-2.47|5.43|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||5.43|-2.47|
71715116|NCT00372957|142945894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-20.4|4.2|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||4.2|-20.4|
71715117|NCT00372957|142945894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||||TWO_SIDED|95.0|-28.4|-3.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||-3.9|-28.4|
71715118|NCT00372957|142945894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||||TWO_SIDED|95.0|-23.1|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-23.1|
71715119|NCT00372957|142945894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-27.9|-3.3|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||-3.3|-27.9|
71715120|NCT00372957|142945895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.64|1.16|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||1.16|-0.64|
71828369|NCT02498769|143161314|OTHER||Odds Ratio (OR)|0.63||||0.19|TWO_SIDED|95.0|0.31|1.27|||Regression, Logistic|||||1.27|0.31|0.19
71715121|NCT00372957|142945895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-0.47|1.32|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||1.32|-0.47|
71715122|NCT00372957|142945895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.37|1.07|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.07|-0.37|
71715123|NCT00372957|142945895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|-0.24|1.21|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||1.21|-0.24|
71715124|NCT00372957|142945896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|||||TWO_SIDED|95.0|-40.7|0.9|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7||0.9|-40.7|
71715125|NCT00372957|142945896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||||TWO_SIDED|95.0|-29.8|11.7|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7||11.7|-29.8|
71715126|NCT00372957|142945896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|||||TWO_SIDED|95.0|-33.2|1.4|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7||1.4|-33.2|
71715127|NCT00372957|142945896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-23.4|11.1|||Double-delta analysis||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7||11.1|-23.4|
71715128|NCT04778592|142945898|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.291||0.4549|TWO_SIDED|95.0|-0.36|0.79|||Mixed Models Analysis|||||0.79|-0.36|0.4549
71715129|NCT04102007|142945912|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 16|57.4|||||TWO_SIDED|95.0|51.1|63.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||63.4|51.1|
71715130|NCT04102007|142945913|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 16|20.5|||||TWO_SIDED|95.0|15.4|26.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.0|15.4|
71715131|NCT04102007|142945914|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 16|40.2|||||TWO_SIDED|95.0|34.2|46.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||46.4|34.2|
71715132|NCT04102007|142945915|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 16|20.9|||||TWO_SIDED|95.0|16.3|26.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||26.4|16.3|
71715133|NCT04102007|142945916|OTHER|There is no statistical test for this study|Proportion of sPGA 0/1 @ WK 52|62.3|||||TWO_SIDED|95.0|56.0|68.1|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||68.1|56.0|
71715134|NCT04102007|142945917|OTHER|There is no statistical test for this study|Proportion of sPGA 0 @ WK 52|27.1|||||TWO_SIDED|95.0|21.9|33.0|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.0|21.9|
71828370|NCT02498769|143161315|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||ICU length of stay hours||||.16
71828371|NCT02498769|143161315|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Hospital LOS||||.51
71715135|NCT04102007|142945918|OTHER|There is no statistical test for this study|Proportion of DLQI 0 or 1 @ WK 52|47.2|||||TWO_SIDED|95.0|41.0|53.4|||Other|There is no test of hypothesis for this study.|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||53.4|41.0|
71715136|NCT04102007|142945919|OTHER|There is no statistical test for this study|Proportion of PSS 0 @ WK 52|27.5|||||TWO_SIDED|95.0|22.3|33.4|||Other|There is no test of hypothesis for this study|Non-Responder Imputation incorporating multiple imputation to handle missing due to COVID-19 for proportion calculation and Wilson score method for confidence interval construction|||33.4|22.3|
71715137|NCT02431325|142945951|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
71715138|NCT02431325|142945952|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71715139|NCT02431325|142945953|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71715140|NCT02431325|142945954|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71715141|NCT02431325|142945955|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71715142|NCT02431325|142945956|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71715143|NCT02431325|142945957|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71767496|NCT03860935|143036843|SUPERIORITY||Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|96.0|5.73|8.46|||Mixed Models Analysis|||LS means are from a MMRM model with treatment group, visit, randomization stratification factors of genotype, NT-proBNP level and eGFR level (as recorded in IXRS) and treatment group-by-visit interaction as factors, and baseline value as covariate. Missing measurements due to early discontinuation of study treatment and due to death were imputed using the Jump to Reference (J2R) method and sampling with replacement from the worst 5% of observed values, respectively, as specified in study SAP.||8.46|5.73|<0.0001
71767497|NCT03860935|143036844|SUPERIORITY||Relative Risk Reduction (%)|25.0||||0.0569|TWO_SIDED|||||Cochran-Mantel-Haenszel test is stratified by randomization stratification factors of genotype, NT-proBNP level and eGFR level as recorded in IXRS.|Cochran-Mantel-Haenszel|||||||0.0569
71828372|NCT02498769|143161316|OTHER|||||||0.97|||||||Chi-squared|||||||.97
71715144|NCT02431325|142945958|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71715145|NCT02431325|142945959|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71715146|NCT02431325|142945960|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71715147|NCT02431325|142945961|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71715148|NCT02431325|142945962|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71715149|NCT02431325|142945963|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71715150|NCT02431325|142945964|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71715151|NCT02431325|142945965|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71715152|NCT02431325|142945966|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71715153|NCT02431325|142945967|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71715154|NCT02431325|142945968|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 24||||0.09
71715155|NCT02431325|142945968|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Change from baseline at week 12||||0.25
71715156|NCT02431325|142945969|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71715157|NCT02431325|142945970|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71715158|NCT00744861|142945971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|||||||Cochran-Mantel-Haenszel|site stratified||||||0.9905
71715159|NCT02347605|142945983|SUPERIORITY|||||||0.25||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.25
71715160|NCT02347605|142945984|SUPERIORITY|||||||0.18||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis|||||||0.18
71715161|NCT03710889|142946044|OTHER|Within treatment paired t-tests were used to compare the differences in dynamic indices between Baseline and Month 3 using the Bone-Biopsy Population. If the normality assumption is not satisfied at the 0.01 significance level and visual inspection of the data deems it necessary, Wilcoxon signed-rank test is used. No adjustments for multiplicity were made. A 2-sided p-value \<0.05 was considered statistically significant.|||||<|0.0001|||||||Paired t-test, 2 sided|||||||<0.0001
71715162|NCT04881760|142946051|SUPERIORITY||LS Mean difference (Final Values)|-5.64|||<|0.001|TWO_SIDED|95.0|-7.34|-3.94|||Mixed Models Analysis|||||-3.94|-7.34|<0.001
71715163|NCT04881760|142946051|SUPERIORITY||LS Mean difference (Final Values)|-10.45|||<|0.001|TWO_SIDED|95.0|-12.21|-8.7|||Mixed Models Analysis|||||-8.70|-12.21|<0.001
71715164|NCT04881760|142946051|SUPERIORITY||LS Mean difference (Final Values)|-12.25|||<|0.001|TWO_SIDED|95.0|-14.42|-10.08|||Mixed Models Analysis|||||-10.08|-14.42|<0.001
71715165|NCT04881760|142946051|SUPERIORITY||LS Mean difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-16.9|-13.3|||Mixed Models Analysis|||||-13.30|-16.90|<0.001
71715166|NCT04881760|142946051|SUPERIORITY||LS Mean difference (Final Values)|-16.72|||<|0.001|TWO_SIDED|95.0|-18.86|-14.58|||Mixed Models Analysis|||||-14.58|-18.86|<0.001
71715167|NCT04881760|142946051|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-17.57|-14.13|||Mixed Models Analysis|||||-14.13|-17.57|<0.001
71715168|NCT04881760|142946052|SUPERIORITY||LS Mean difference (Final Values)|-6.57|||<|0.001|TWO_SIDED|95.0|-8.94|-4.2|||Mixed Models Analysis|||||-4.20|-8.94|<0.001
71715169|NCT04881760|142946052|SUPERIORITY||LS Mean difference (Final Values)|-14.21|||<|0.001|TWO_SIDED|95.0|-17.64|-10.78|||Mixed Models Analysis|||||-10.78|-17.64|<0.001
71715170|NCT04881760|142946052|SUPERIORITY||LS Mean difference (Final Values)|-15.72|||<|0.001|TWO_SIDED|95.0|-19.05|-12.4|||Mixed Models Analysis|||||-12.40|-19.05|<0.001
71715171|NCT04881760|142946052|SUPERIORITY||LS Mean difference (Final Values)|-19.62|||<|0.001|TWO_SIDED|95.0|-22.73|-16.51|||Mixed Models Analysis|||||-16.51|-22.73|<0.001
71715172|NCT04881760|142946052|SUPERIORITY||LS Mean difference (Final Values)|-21.78|||<|0.001|TWO_SIDED|95.0|-25.05|-18.51|||Mixed Models Analysis|||||-18.51|-25.05|<0.001
71715173|NCT04881760|142946052|SUPERIORITY||LS Mean difference (Final Values)|-22.11|||<|0.001|TWO_SIDED|95.0|-24.92|-19.31|||Mixed Models Analysis|||||-19.31|-24.92|<0.001
71715174|NCT04881760|142946053|SUPERIORITY||Risk Difference (RD)|33.0|||<|0.001|TWO_SIDED|95.0|17.0|49.0|||Regression, Logistic|||||49|17|<0.001
71886970|NCT00915343|143294313|SUPERIORITY_OR_OTHER_LEGACY||least square mean|-0.064||||0.4625|TWO_SIDED|95.0|-0.235|0.107|||Fisher's test|Fisher's non||Investigator||0.107|-0.235|0.4625
71715175|NCT04881760|142946053|SUPERIORITY||Risk Difference (RD)|61.0|||<|0.001|TWO_SIDED|95.0|45.0|77.0|||Regression, Logistic|||||77|45|<0.001
71715176|NCT04881760|142946053|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|54.0|81.0|||Regression, Logistic|||||81|54|<0.001
71715177|NCT04881760|142946053|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
71715178|NCT04881760|142946053|SUPERIORITY||Risk Difference (RD)|74.0|||<|0.001|TWO_SIDED|95.0|63.0|85.0|||Regression, Logistic|||||85|63|<0.001
71715179|NCT04881760|142946053|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|59.0|82.0|||Regression, Logistic|||||82|59|<0.001
71715180|NCT04881760|142946054|SUPERIORITY||Risk Difference (RD)|37.0|||<|0.001|TWO_SIDED|95.0|20.0|54.0|||Regression, Logistic|||||54|20|<0.001
71715181|NCT04881760|142946054|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.001|TWO_SIDED|95.0|44.0|76.0|||Regression, Logistic|||||76|44|<0.001
71715182|NCT04881760|142946054|SUPERIORITY||Risk Difference (RD)|70.0|||<|0.001|TWO_SIDED|95.0|57.0|83.0|||Regression, Logistic|||||83|57|<0.001
71715183|NCT04881760|142946054|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
71715184|NCT04881760|142946054|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|62.0|84.0|||Regression, Logistic|||||84|62|<0.001
71715185|NCT04881760|142946054|SUPERIORITY||Risk Difference (RD)|73.0|||<|0.001|TWO_SIDED|95.0|67.0|84.0|||Regression, Logistic|||||84|67|<0.001
71715186|NCT04881760|142946055|SUPERIORITY||Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|11.0|33.0|||Regression, Logistic|||||33|11|<0.001
71715187|NCT04881760|142946055|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|38.0|73.0|||Regression, Logistic|||||73|38|<0.001
71715188|NCT04881760|142946055|SUPERIORITY||Risk Difference (RD)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|85.0|||Regression, Logistic|||||85|53|<0.001
71715189|NCT04881760|142946055|SUPERIORITY||Risk Difference (RD)|80.0|||<|0.001|TWO_SIDED|95.0|66.0|93.0|||Regression, Logistic|||||93|66|<0.001
71767498|NCT01105065|143036871|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared, Corrected|||There would be no change in retinal vascular dysregulation after treatment with brimonidine||||<0.0001
71767499|NCT01105065|143036872|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t-test|||A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.||||0.28
71767500|NCT00853996|143036893|OTHER||||||<|0.001||||||No adjustment for multiple comparisons since this was primary endpoint. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71767501|NCT00853996|143036894|OTHER|||||||0.067||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05.|Wilcoxon (Mann-Whitney)|||||||0.067
71767502|NCT00853996|143036895|OTHER|||||||0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
71767503|NCT00853996|143036896|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at \<0.05|Wilcoxon (Mann-Whitney)|||||||0.002
71767504|NCT00853996|143036897|OTHER|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance set at 0.05|Wilcoxon (Mann-Whitney)|||||||0.002
71767505|NCT04876690|143036943|SUPERIORITY||||||=|0.1217|||||||t-test for Independent Samples|||PCS-12: Sex||||=0.1217
71767506|NCT04876690|143036943|SUPERIORITY||||||=|0.8241|||||||ANOVA|ANOVA=Analysis of variance||PCS-12: Employment Status||||=0.8241
71715190|NCT04881760|142946055|SUPERIORITY||Risk Difference (RD)|91.0|||<|0.001|TWO_SIDED|95.0|83.0|100.0|||Regression, Logistic|||||100|83|<0.001
71715191|NCT04881760|142946055|SUPERIORITY||Risk Difference (RD)|87.0|||<|0.001|TWO_SIDED|95.0|78.0|96.0|||Regression, Logistic|||||96|78|<0.001
71715192|NCT04881760|142946056|SUPERIORITY||Risk Difference (RD)|18.0||||0.008|TWO_SIDED|95.0|5.0|31.0|||Regression, Logistic|||||31|5|0.008
71715193|NCT04881760|142946056|SUPERIORITY||Risk Difference (RD)|64.0|||<|0.001|TWO_SIDED|95.0|48.0|81.0|||Regression, Logistic|||||81|48|<0.001
71715194|NCT04881760|142946056|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|84.0|||Regression, Logistic|||||84|51|<0.001
71715195|NCT04881760|142946056|SUPERIORITY||Risk Difference (RD)|81.0|||<|0.001|TWO_SIDED|95.0|69.0|94.0|||Regression, Logistic|||||94|69|<0.001
71715196|NCT04881760|142946056|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|94.0|||Regression, Logistic|||||94|71|<0.001
71715197|NCT04881760|142946056|SUPERIORITY||Risk Difference (RD)|84.0|||<|0.001|TWO_SIDED|95.0|74.0|94.0|||Regression, Logistic|||||94|74|<0.001
71715198|NCT04881760|142946057|SUPERIORITY||Risk Difference (RD)|9.0||||0.029|TWO_SIDED|95.0|1.0|17.0|||Regression, Logistic|||||17|1|0.029
71715199|NCT04881760|142946057|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|11.0|43.0|||Regression, Logistic|||||43|11|<0.001
71767507|NCT04876690|143036943|SUPERIORITY||||||=|0.3471|||||||ANOVA|||PCS-12: Smoking Status||||=0.3471
71767508|NCT04876690|143036943|SUPERIORITY||||||=|0.9951|||||||ANOVA|||PCS-12: Age at Onset||||=0.9951
71767509|NCT04876690|143036943|SUPERIORITY||||||=|0.0631|||||||ANOVA|||PCS-12: Disease Location||||=0.0631
71767510|NCT04876690|143036943|SUPERIORITY||||||=|0.7473|||||||ANOVA|||PCS-12: Disease Behavior||||=0.7473
71767511|NCT04876690|143036943|SUPERIORITY||||||=|0.4422|||||||t-test for Independent Samples|||PCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.4422
71767512|NCT04876690|143036943|SUPERIORITY||||||=|0.1796|||||||t-test for Independent Samples|||PCS-12: Fistula With High Intersphincteric Type||||=0.1796
71767513|NCT04876690|143036943|SUPERIORITY||||||=|0.3535|||||||t-test for Independent Samples|||PCS-12: Fistula With High Transsphincteric Type||||=0.3535
71767514|NCT04876690|143036943|SUPERIORITY||||||=|0.1508|||||||t-test for Independent Samples|||PCS-12: Fistula With Suprasphincteric Type||||=0.1508
71767515|NCT04876690|143036943|SUPERIORITY||||||=|0.2671|||||||t-test for Independent Samples|||PCS-12: Fistula with Extrasphincteric Type||||=0.2671
71767516|NCT04876690|143036943|SUPERIORITY||||||=|0.0594|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Intersphincteric Type||||=0.0594
71767517|NCT04876690|143036943|SUPERIORITY||||||=|0.5484|||||||t-test for Independent Samples|||PCS-12: Fistula With Low Transsphincteric Type||||=0.5484
71767518|NCT04876690|143036943|SUPERIORITY||||||=|0.5387|||||||t-test for Independent Samples|||PCS-12: Fistula With Midline Position||||=0.5387
71715200|NCT04881760|142946057|SUPERIORITY||Risk Difference (RD)|43.0|||<|0.001|TWO_SIDED|95.0|26.0|60.0|||Regression, Logistic|||||60|26|<0.001
71715201|NCT04881760|142946057|SUPERIORITY||Risk Difference (RD)|49.0|||<|0.001|TWO_SIDED|95.0|33.0|66.0|||Regression, Logistic|||||66|33|<0.001
71715202|NCT04881760|142946057|SUPERIORITY||Risk Difference (RD)|67.0|||<|0.001|TWO_SIDED|95.0|51.0|83.0|||Regression, Logistic|||||83|51|<0.001
71715203|NCT04881760|142946057|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|56.0|80.0|||Regression, Logistic|||||80|56|<0.001
71715204|NCT04881760|142946058|SUPERIORITY||Risk Difference (RD)|15.0||||0.002|TWO_SIDED|95.0|6.0|24.0|||Regression, Logistic|||||24|6|0.002
71715205|NCT04881760|142946058|SUPERIORITY||Risk Difference (RD)|53.0|||<|0.001|TWO_SIDED|95.0|36.0|70.0|||Regression, Logistic|||||70|36|<0.001
71715206|NCT04881760|142946058|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|47.0|79.0|||Regression, Logistic|||||79|47|<0.001
71715207|NCT04881760|142946058|SUPERIORITY||Risk Difference (RD)|71.0|||<|0.001|TWO_SIDED|95.0|55.0|87.0|||Regression, Logistic|||||87|55|<0.001
71715208|NCT04881760|142946058|SUPERIORITY||Risk Difference (RD)|75.0|||<|0.001|TWO_SIDED|95.0|62.0|89.0|||Regression, Logistic|||||89|62|<0.001
71715209|NCT04881760|142946058|SUPERIORITY||Risk Difference (RD)|82.0|||<|0.001|TWO_SIDED|95.0|71.0|92.0|||Regression, Logistic|||||92|71|<0.001
71715210|NCT04881760|142946059|SUPERIORITY||LS Mean difference (Final Values)|-6.46|||<|0.001|TWO_SIDED|95.0|-8.36|-4.56|||Mixed Models Analysis|||||-4.56|-8.36|<0.001
71767519|NCT04876690|143036943|SUPERIORITY||||||=|0.527|||||||t-test for Independent Samples|||PCS-12: Fistula With Lateral Position||||=0.5270
71767520|NCT04876690|143036943|SUPERIORITY||||||=|0.3863|||||||t-test for Independent Samples|||PCS-12: Fistula With Seton||||=0.3863
71828373|NCT02739035|143161317|SUPERIORITY|A difference of 10 degrees in total mean range of motion between the control and the treatment group was considered a clinically significant improvement.||||||0.23||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.23
71886971|NCT00915343|143294314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6072|TWO_SIDED||||||Sign test|||Patient||||0.6072
71715211|NCT04881760|142946059|SUPERIORITY||LS Mean difference (Final Values)|-11.32|||<|0.001|TWO_SIDED|95.0|-13.34|-9.3|||Mixed Models Analysis|||||-9.30|-13.34|<0.001
71715212|NCT04881760|142946059|SUPERIORITY||LS Mean difference (Final Values)|-13.52|||<|0.001|TWO_SIDED|95.0|-15.99|-11.05|||Mixed Models Analysis|||||-11.05|-15.99|<0.001
71767521|NCT04876690|143036943|SUPERIORITY||||||=|0.4206|||||||ANOVA|||PCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4206
71886972|NCT00915343|143294314|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Sign test|||Investigator||||1.0000
71715213|NCT04881760|142946059|SUPERIORITY||LS Mean difference (Final Values)|-16.43|||<|0.001|TWO_SIDED|95.0|-18.41|-14.45|||Mixed Models Analysis|||||-14.45|-18.41|<0.001
71715214|NCT04881760|142946059|SUPERIORITY||LS Mean difference (Final Values)|-18.48|||<|0.001|TWO_SIDED|95.0|-20.93|-16.04|||Mixed Models Analysis|||||-16.04|-20.93|<0.001
71767522|NCT04876690|143036943|SUPERIORITY||||||=|0.0538|||||||t-test for Independent Samples|||PCS-12: Surgery-naïve||||=0.0538
71767523|NCT04876690|143036943|SUPERIORITY||||||=|0.9572|||||||t-test for Independent Samples|||PCS-12: Surgery - Fistulotomy||||=0.9572
71767524|NCT04876690|143036943|SUPERIORITY||||||=|0.4742|||||||t-test for Independent Samples|||PCS-12: Surgery - Loose Seton||||=0.4742
71767525|NCT04876690|143036943|SUPERIORITY||||||=|0.5735|||||||t-test for Independent Samples|||PCS-12: Surgery - Other||||=0.5735
71715215|NCT04881760|142946059|SUPERIORITY||LS Mean difference (Final Values)|-17.26|||<|0.001|TWO_SIDED|95.0|-19.11|-15.4|||Mixed Models Analysis|||||-15.40|-19.11|<0.001
71715216|NCT04881760|142946060|SUPERIORITY||LS Mean difference (Final Values)|-7.53|||<|0.001|TWO_SIDED|95.0|-10.18|-4.88|||Mixed Models Analysis|||||-4.88|-10.18|<0.001
71715217|NCT04881760|142946060|SUPERIORITY||LS Mean difference (Final Values)|-15.48|||<|0.001|TWO_SIDED|95.0|-19.35|-11.6|||Mixed Models Analysis|||||-11.60|-19.35|<0.001
71715218|NCT04881760|142946060|SUPERIORITY||LS Mean difference (Final Values)|-17.29|||<|0.001|TWO_SIDED|95.0|-21.19|-13.39|||Mixed Models Analysis|||||-13.39|-21.19|<0.001
71715219|NCT04881760|142946060|SUPERIORITY||LS Mean difference (Final Values)|-21.69|||<|0.001|TWO_SIDED|95.0|-25.25|-18.12|||Mixed Models Analysis|||||-18.12|-25.25|<0.001
71715220|NCT04881760|142946060|SUPERIORITY||LS Mean difference (Final Values)|-24.04|||<|0.001|TWO_SIDED|95.0|-27.72|-20.36|||Mixed Models Analysis|||||-20.36|-27.72|<0.001
71715221|NCT04881760|142946060|SUPERIORITY||LS Mean difference (Final Values)|-24.34|||<|0.001|TWO_SIDED|95.0|-27.4|-21.27|||Mixed Models Analysis|||||-21.27|-27.40|<0.001
71715222|NCT04881760|142946061|SUPERIORITY||LS Mean difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||Mixed Models Analysis|||||-1.50|-2.80|<0.001
71715223|NCT04881760|142946061|SUPERIORITY||LS Mean difference (Final Values)|-3.98|||<|0.001|TWO_SIDED|95.0|-4.66|-3.29|||Mixed Models Analysis|||||-3.29|-4.66|<0.001
71715224|NCT04881760|142946061|SUPERIORITY||LS Mean difference (Final Values)|-4.64|||<|0.001|TWO_SIDED|95.0|-5.46|-3.82|||Mixed Models Analysis|||||-3.82|-5.46|<0.001
71715225|NCT04881760|142946061|SUPERIORITY||LS Mean difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-6.34|-4.99|||Mixed Models Analysis|||||-4.99|-6.34|<0.001
71715226|NCT04881760|142946061|SUPERIORITY||LS Mean difference (Final Values)|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.53|||Mixed Models Analysis|||||-5.53|-7.17|<0.001
71715227|NCT04881760|142946061|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-6.59|-5.32|||Mixed Models Analysis|||||-5.32|-6.59|<0.001
71715228|NCT04881760|142946062|SUPERIORITY||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.42|-1.57|||Mixed Models Analysis|||||-1.57|-3.42|<0.001
71715229|NCT04881760|142946062|SUPERIORITY||LS Mean difference (Final Values)|-5.42|||<|0.001|TWO_SIDED|95.0|-6.81|-4.03|||Mixed Models Analysis|||||-4.03|-6.81|<0.001
71715230|NCT04881760|142946062|SUPERIORITY||LS Mean difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-7.23|-4.67|||Mixed Models Analysis|||||-4.67|-7.23|<0.001
71715231|NCT04881760|142946062|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-8.62|-6.18|||Mixed Models Analysis|||||-6.18|-8.62|<0.001
71715232|NCT04881760|142946062|SUPERIORITY||LS Mean difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-9.55|-7.05|||Mixed Models Analysis|||||-7.05|-9.55|<0.001
71715233|NCT04881760|142946062|SUPERIORITY||LS Mean difference (Final Values)|-8.42|||<|0.001|TWO_SIDED|95.0|-9.49|-7.35|||Mixed Models Analysis|||||-7.35|-9.49|<0.001
71715234|NCT04881760|142946063|SUPERIORITY||LS Mean difference (Final Values)|-2.82||||0.022|TWO_SIDED|95.0|-5.23|-0.41|||Mixed Models Analysis|||||-0.41|-5.23|0.022
71767526|NCT04876690|143036943|SUPERIORITY||||||=|0.376|||||||t-test for Independent Samples|||PCS-12: Presence of Perianal Abscess||||=0.3760
71767527|NCT04876690|143036944|SUPERIORITY||||||=|0.4814|||||||t-test for Independent Samples|||MCS-12: Sex||||=0.4814
71767528|NCT04876690|143036944|SUPERIORITY||||||=|0.3136|||||||Kruskal-Wallis|||MCS-12: Employment Status||||=0.3136
71767529|NCT04876690|143036944|SUPERIORITY||||||=|0.5808|||||||ANOVA|||MCS-12: Smoking Status||||=0.5808
71767530|NCT04876690|143036944|SUPERIORITY||||||=|0.2965|||||||ANOVA|||MCS-12: Age at Onset||||=0.2965
71767531|NCT04876690|143036944|SUPERIORITY||||||=|0.2874|||||||ANOVA|||MCS-12: Disease Location||||=0.2874
71886973|NCT00915343|143294315|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.6||||0.3332|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.3332
71715235|NCT04881760|142946063|SUPERIORITY||LS Mean difference (Final Values)|-7.73|||<|0.001|TWO_SIDED|95.0|-10.32|-5.13|||Mixed Models Analysis|||||-5.13|-10.32|<0.001
71886974|NCT00915343|143294315|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|0.9||||0.3405|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3405
71715236|NCT04881760|142946063|SUPERIORITY||LS Mean difference (Final Values)|-9.95|||<|0.001|TWO_SIDED|95.0|-12.47|-7.43|||Mixed Models Analysis|||||-7.43|-12.47|<0.001
71715237|NCT04881760|142946063|SUPERIORITY||LS Mean difference (Final Values)|-11.14|||<|0.001|TWO_SIDED|95.0|-13.72|-8.56|||Mixed Models Analysis|||||-8.56|-13.72|<0.001
71715238|NCT04881760|142946063|SUPERIORITY||LS Mean difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-14.87|-9.9|||Mixed Models Analysis|||||-9.90|-14.87|<0.001
71715239|NCT04881760|142946063|SUPERIORITY||LS Mean difference (Final Values)|-11.73|||<|0.001|TWO_SIDED|95.0|-14.04|-9.43|||Mixed Models Analysis|||||-9.43|-14.04|<0.001
71767532|NCT04876690|143036944|SUPERIORITY||||||=|0.4269|||||||ANOVA|||MCS-12: Disease Behavior||||=0.4269
71767533|NCT04876690|143036944|SUPERIORITY||||||=|0.8931|||||||t-test for Independent Samples|||MCS-12: Presence of any Extraintestinal Manifestation of CD||||=0.8931
71767534|NCT04876690|143036944|SUPERIORITY||||||=|0.9384|||||||t-test for Independent Samples|||MCS-12: Fistula With High Intersphincteric Type||||=0.9384
71767535|NCT04876690|143036944|SUPERIORITY||||||=|0.8286|||||||Mann-Whitney|||MCS-12: Fistula With High Transsphincteric Type||||=0.8286
71886975|NCT00915343|143294316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8418|TWO_SIDED||||||Wilcoxon Signed Rank|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score||||0.8418
71715240|NCT04881760|142946064|SUPERIORITY||LS Mean difference (Final Values)|-3.84||||0.01|TWO_SIDED|95.0|-6.77|-0.91|||Mixed Models Analysis|||||-0.91|-6.77|0.010
71715241|NCT04881760|142946064|SUPERIORITY||LS Mean difference (Final Values)|-11.94|||<|0.001|TWO_SIDED|95.0|-15.54|-8.33|||Mixed Models Analysis|||||-8.33|-15.54|<0.001
71715242|NCT04881760|142946064|SUPERIORITY||LS Mean difference (Final Values)|-12.22|||<|0.001|TWO_SIDED|95.0|-16.11|-8.33|||Mixed Models Analysis|||||-8.33|-16.11|<0.001
71715243|NCT04881760|142946064|SUPERIORITY||LS Mean difference (Final Values)|-15.88|||<|0.001|TWO_SIDED|95.0|-19.33|-12.43|||Mixed Models Analysis|||||-12.43|-19.33|<0.001
71715244|NCT04881760|142946064|SUPERIORITY||LS Mean difference (Final Values)|-15.85|||<|0.001|TWO_SIDED|95.0|-19.39|-12.31|||Mixed Models Analysis|||||-12.31|-19.39|<0.001
71715245|NCT04881760|142946064|SUPERIORITY||LS Mean difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-20.13|-13.78|||Mixed Models Analysis|||||-13.78|-20.13|<0.001
71767536|NCT04876690|143036944|SUPERIORITY||||||=|0.1919|||||||t-test for Independent Samples|||MCS-12: Fistula With Suprasphincteric Type||||=0.1919
71767537|NCT04876690|143036944|SUPERIORITY||||||=|0.6452|||||||t-test for Independent Samples|||MCS-12: Fistula with Extrasphincteric Type||||=0.6452
71767538|NCT04876690|143036944|SUPERIORITY||||||=|0.7218|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Intersphincteric Type||||=0.7218
71767539|NCT04876690|143036944|SUPERIORITY||||||=|0.9738|||||||t-test for Independent Samples|||MCS-12: Fistula With Low Transsphincteric Type||||=0.9738
71767540|NCT04876690|143036944|SUPERIORITY||||||=|0.2419|||||||t-test for Independent Samples|||MCS-12: Fistula With Midline Position||||=0.2419
71767541|NCT04876690|143036944|SUPERIORITY||||||=|0.5524|||||||t-test for Independent Samples|||MCS-12: Fistula With Lateral Position||||=0.5524
71767542|NCT04876690|143036944|SUPERIORITY||||||=|0.4443|||||||t-test for Independent Samples|||MCS-12: Fistula With Seton||||=0.4443
71767543|NCT04876690|143036944|SUPERIORITY||||||=|0.4106|||||||ANOVA|||MCS-12: HBI Categories (Remission, Mild and Moderate Activity)||||=0.4106
71767544|NCT04876690|143036944|SUPERIORITY||||||=|0.7795|||||||t-test for Independent Samples|||MCS-12: Surgery-naïve||||=0.7795
71767545|NCT04876690|143036944|SUPERIORITY||||||=|0.2964|||||||t-test for Independent Samples|||MCS-12: Surgery - Fistulotomy||||=0.2964
71767546|NCT04876690|143036944|SUPERIORITY||||||=|0.3287|||||||t-test for Independent Samples|||MCS-12: Surgery - Loose Seton||||=0.3287
71767547|NCT04876690|143036944|SUPERIORITY||||||=|0.0091|||||||t-test for Independent Samples|||MCS-12: Surgery - Other||||=0.0091
71767548|NCT04876690|143036944|SUPERIORITY||||||=|0.3889|||||||t-test for Independent Samples|||MCS-12: Presence of Perianal Abscess||||=0.3889
71767549|NCT04876690|143036945|SUPERIORITY||||||=|0.8001|||||||Pearson Correlation Coefficient|||PCS- 12: Age||||=0.8001
71767550|NCT04876690|143036945|SUPERIORITY||||||=|0.4532|||||||Pearson Correlation Coefficient|||PCS- 12: BMI||||=0.4532
71767551|NCT04876690|143036945|SUPERIORITY||||||=|0.9597|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.9597
71886976|NCT00915343|143294316|SUPERIORITY_OR_OTHER_LEGACY|||||||0.355|TWO_SIDED||||||Wilcoxon Signed Rank test|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score||||0.3550
71767552|NCT04876690|143036945|SUPERIORITY||||||=|0.3304|||||||Spearman Correlation Coefficient|||PCS- 12: Total Number of CPFs per Participant||||=0.3304
71767553|NCT04876690|143036945|SUPERIORITY||||||=|0.6333|||||||Pearson Correlation Coefficient|||PCS- 12: Time Since Seton Replacement||||=0.6333
71767554|NCT04876690|143036945|SUPERIORITY||||||=|0.8003|||||||Spearman Correlation Coefficient|||PCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.8003
71767555|NCT04876690|143036945|SUPERIORITY||||||=|0.0032|||||||Pearson Correlation Coefficient|||PCS- 12: PDAI Score||||=0.0032
71767556|NCT04876690|143036945|SUPERIORITY||||||=|0.0923|||||||Spearman Correlation Coefficient|||PCS- 12: Number of Internal Fistula Openings per Participant||||=0.0923
71767557|NCT04876690|143036945|SUPERIORITY||||||=|0.0994|||||||Spearman Correlation Coefficient|||PCS- 12: Number of External Fistula Openings per Participant||||=0.0994
71767558|NCT04876690|143036945|SUPERIORITY||||||=|0.0444|||||||Pearson Correlation Coefficient|||PCS- 12: SIBDQ Score||||=0.0444
71767559|NCT04876690|143036945|SUPERIORITY||||||=|0.086|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-M Score||||=0.0860
71767560|NCT04876690|143036945|SUPERIORITY||||||=|0.9415|||||||Pearson Correlation Coefficient|||PCS- 12: SQoL-F Score||||=0.9415
71767561|NCT04876690|143036945|SUPERIORITY||||||=|0.3709|||||||Pearson Correlation Coefficient|||PCS- 12: Wexner Score||||=0.3709
71767562|NCT04876690|143036946|SUPERIORITY||||||=|0.0674|||||||Pearson Correlation Coefficient|||MCS- 12: Age||||=0.0674
71767563|NCT04876690|143036946|SUPERIORITY||||||=|0.9392|||||||Pearson Correlation Coefficient|||MCS- 12: BMI||||=0.9392
71767564|NCT04876690|143036946|SUPERIORITY||||||=|0.6387|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between CD Diagnosis Date and Date of Study Visit||||=0.6387
71767565|NCT04876690|143036946|SUPERIORITY||||||=|0.7846|||||||Spearman Correlation Coefficient|||MCS- 12: Total Number of CPFs per Participant||||=0.7846
71767566|NCT04876690|143036946|SUPERIORITY||||||=|0.3972|||||||Pearson Correlation Coefficient|||MCS- 12: Time Since Seton Placement||||=0.3972
71767567|NCT04876690|143036946|SUPERIORITY||||||=|0.9496|||||||Spearman Correlation Coefficient|||MCS- 12: Time Between First CPF Diagnosis Date and Date of Study Visit||||=0.9496
71767568|NCT04876690|143036946|SUPERIORITY||||||=|0.813|||||||Pearson Correlation Coefficient|||MCS- 12: PDAI Score||||=0.8130
71767569|NCT04876690|143036946|SUPERIORITY||||||=|0.4588|||||||Spearman Correlation Coefficient|||MCS- 12: Number of Internal Fistula Openings per Participant||||=0.4588
71767570|NCT04876690|143036946|SUPERIORITY||||||=|0.8663|||||||Spearman Correlation Coefficient|||MCS- 12: Number of External Fistula Openings per Participant||||=0.8663
71767571|NCT04876690|143036946|SUPERIORITY||||||=|0.1349|||||||Pearson Correlation Coefficient|||MCS- 12: SIBDQ Score||||=0.1349
71767572|NCT04876690|143036946|SUPERIORITY||||||=|0.5647|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-M Score||||=0.5647
71767573|NCT04876690|143036946|SUPERIORITY||||||=|0.9509|||||||Pearson Correlation Coefficient|||MCS- 12: SQoL-F Score||||=0.9509
71767574|NCT04876690|143036946|SUPERIORITY||||||=|0.5328|||||||Pearson Correlation Coefficient|||MCS- 12: Wexner Score||||=0.5328
71767575|NCT02660138|143036947|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-10.83||||0.0001|TWO_SIDED|95.0|-16.36|-5.31|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.31|-16.36|0.0001
71767576|NCT02660138|143036947|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025.|LS Mean Difference|-12.19|||<|0.0001|TWO_SIDED|95.0|-17.65|-6.73|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-6.73|-17.65|<0.0001
71767577|NCT02660138|143036948|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|160.9|||<|0.0001|TWO_SIDED|95.0|109.9|211.9|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||211.9|109.9|<0.0001
71767578|NCT02660138|143036948|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|189.2|||<|0.0001|TWO_SIDED|95.0|140.1|238.2|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||238.2|140.1|<0.0001
71767579|NCT02660138|143036949|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-16.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-16.4|-32.3|<0.0001
71767580|NCT02660138|143036949|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.2|-21.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-21.1|-36.2|<0.0001
71767581|NCT02660138|143036950|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|155.5|||<|0.0001|TWO_SIDED|95.0|100.5|210.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||210.4|100.5|<0.0001
71715246|NCT01538199|142946077|SUPERIORITY_OR_OTHER|||||||0.04||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|We used a modified intent-to-treat approach with LOCF and unpaired Student's t-test (one-way), comparing the change in total severity score.||||||0.04
71715247|NCT01538199|142946077|SUPERIORITY_OR_OTHER|||||||0.08||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.||||||0.08
71715248|NCT01538199|142946077|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.01
71715249|NCT01538199|142946077|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).||||0.02
71715250|NCT01538199|142946077|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.||||0.004
71715251|NCT01538199|142946080|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.||||||0.18
71715252|NCT01538199|142946080|SUPERIORITY_OR_OTHER|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to measure the change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.01
71715253|NCT01538199|142946080|SUPERIORITY_OR_OTHER|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test measuring change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.||||0.02
71715254|NCT00271544|142946126|SUPERIORITY_OR_OTHER||One sample proportion|0.955||||||95.0|0.92|0.955|||||1-side 95% confidence limit lower bound|||0.955|0.92|
71715255|NCT00271544|142946127|SUPERIORITY_OR_OTHER||One sample proportion|0.96||||||95.0|0.932|0.989||||||||0.989|0.932|
71715256|NCT00271544|142946128|SUPERIORITY_OR_OTHER||One sample mean|1.1|STANDARD_DEVIATION|0.9||||95.0|1.1|1.2|||||1-side 95% confidence limit upper bound|||1.2|1.1|
71715257|NCT00271544|142946129|SUPERIORITY_OR_OTHER||One sample mean|1.9|STANDARD_DEVIATION|2.0||||97.5|1.9|2.2|||||1-sided 97.5% confidence limit upper bound|||2.2|1.9|
71715258|NCT00271544|142946130|SUPERIORITY_OR_OTHER||One sample proportion|0.989||||||95.0|0.974|1.0||||||||1|0.974|
71715259|NCT00271544|142946131|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
71767582|NCT02660138|143036950|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|181.8|||<|0.0001|TWO_SIDED|95.0|129.2|234.3|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||234.3|129.2|<0.0001
71715260|NCT00271544|142946132|SUPERIORITY_OR_OTHER||One sample proportion|0.973||||||95.0|0.95|0.996||||||||0.996|0.950|
71715261|NCT03358030|142946146|OTHER||||||<|0.05|||||||ANOVA|||Day 12 through Day 260||||<0.05
71715262|NCT03358030|142946146|OTHER||||||<|0.05|||||||ANOVA|||Day 15 through Day 232||||<0.05
71715263|NCT03358030|142946147|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 15 through Day 176||||< 0.05
71715264|NCT03358030|142946147|OTHER||||||<|0.05|||||||Wilcoxon Rank Sum Test|Wilcoxon Rank Sum Test based on t approximation||Day 12 through Day 176||||< 0.05
71715265|NCT00829244|142946152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.037|TWO_SIDED|95.0|-3.3|-0.1|||ANOVA|||The null hypothesis was that the difference between the mean number of oocytes \[CONSORT calculator dosing - Standard dosing\] was less than or equal to \[=\<\] (-3). The alternate hypothesis was that the difference was greater than \[\>\] (-3).||-0.1|-3.3|0.037
71715266|NCT00829244|142946153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-511.37|STANDARD_ERROR_OF_MEAN|64.52|<|0.001|TWO_SIDED|95.0|-638.78|-383.96|||ANOVA|||||-383.96|-638.78|<0.001
71886977|NCT00915343|143294317|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-2.9||||0.0823|TWO_SIDED||||||Fisher's|Fisher's non-parametric two-sample permutation test||||||0.0823
71715267|NCT00829244|142946154|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.6|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-53.75|-37.46|||ANOVA|||||-37.46|-53.75|<0.001
71715268|NCT00829244|142946155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.933|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.933
71715269|NCT00829244|142946157|SUPERIORITY_OR_OTHER||Percent difference|3.6|||||TWO_SIDED|95.0|-11.0|18.2||||||||18.2|-11.0|
71715270|NCT00829244|142946159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|6.6||0.926|TWO_SIDED|95.0|-12.3|13.6|||ANOVA|||||13.6|-12.3|0.926
71715271|NCT00829244|142946161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.78||0.235|TWO_SIDED|95.0|-0.61|2.47|||ANOVA|||||2.47|-0.61|0.235
71715272|NCT00829244|142946162|SUPERIORITY_OR_OTHER||Percent difference|0.6|||||TWO_SIDED|95.0|-13.5|14.6||||||||14.6|-13.5|
71715273|NCT02297412|142946204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|||||||Wilcoxon (Mann-Whitney)|||||||0.0186
71715274|NCT02297412|142946205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1146|||||||Wilcoxon (Mann-Whitney)|||||||0.1146
71715275|NCT02297412|142946206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0243|||||||Wilcoxon (Mann-Whitney)|||||||0.0243
71715276|NCT02031302|142946207|OTHER|One-sided Clopper-Pearson 98.699% upper bound|||||<|0.0001||||||The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.|Chi-squared|||Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.|One-sided Clopper-Pearson 98.699% upper bound: 4.11% Performance goal is 14%|||<.0001
71715277|NCT03950856|142946216|OTHER||Difference in Percentage|1.3||||0.538|TWO_SIDED|95.0|-3.3|4.8|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site erythema: V114 Combined Lots - Prevnar 13™||4.8|-3.3|0.538
71715278|NCT03950856|142946216|OTHER||Difference in Percentage|14.6|||<|0.001|TWO_SIDED|95.0|7.9|21.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site pain: V114 Combined Lots - Prevnar 13™||21.4|7.9|<0.001
71715279|NCT03950856|142946216|OTHER||Difference in Percentage|1.0||||0.686|TWO_SIDED|95.0|-4.3|5.3|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Injection site swelling: V114 Combined Lots - Prevnar 13™||5.3|-4.3|0.686
71715280|NCT03950856|142946218|OTHER||Difference in Percentage|2.0||||0.272|TWO_SIDED|95.0|-1.9|4.7|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Arthralgia: V114 Combined Lots - Prevnar 13™||4.7|-1.9|0.272
71715281|NCT03950856|142946218|OTHER||Difference in Percentage|-0.7||||0.812|TWO_SIDED|95.0|-6.7|4.5|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Fatigue: V114 Combined Lots - Prevnar 13™||4.5|-6.7|0.812
71715282|NCT03950856|142946218|OTHER||Difference in Percentage|0.2||||0.947|TWO_SIDED|95.0|-5.6|5.0|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Headache: V114 Combined Lots - Prevnar 13™||5.0|-5.6|0.947
71715283|NCT03950856|142946218|OTHER||Difference in Percentage|5.2||||0.091|TWO_SIDED|95.0|-0.9|10.4|||Miettinen & Nurminen||V114 Combined Lots minus Prevnar 13™|Myalgia: V114 Combined Lots - Prevnar 13™||10.4|-0.9|0.091
71715284|NCT03950856|142946220|OTHER||Miettinen & Nurminen|0.0|||||TWO_SIDED|95.0|-1.6|0.2|||||V114 Combined Lots minus Prevnar 13™|V114 Combined Lots - Prevnar 13™||0.2|-1.6|
71715285|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.83|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.83|<0.001
71767583|NCT02660138|143036951|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|9.83||||0.0006|TWO_SIDED|95.0|2.72|35.6|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||35.60|2.72|0.0006
71886978|NCT00915343|143294318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5982|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5982
71715286|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
71715287|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.88|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|<0.001
71715288|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.75|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.75|<0.001
71886979|NCT00915343|143294319|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|2.3||||0.0632|TWO_SIDED||||||Fisher's test|Fisher's non-parametric two-sample permutation test||||||0.0632
71715289|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
71715290|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.95|<0.001
71886980|NCT00915343|143294320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8676|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.8676
71886981|NCT00915343|143294321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9700
71886982|NCT00915343|143294322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.2624
71715291|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.7|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.97|0.70|<0.001
71886983|NCT00915343|143294323|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|1.28|||||TWO_SIDED|||||||||||||
71715292|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.85|<0.001
71715293|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.21|||<|0.001|TWO_SIDED|95.0|1.03|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.03|<0.001
71715294|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.7|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.70|<0.001
71715295|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.83|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.20|0.83|<0.001
71767584|NCT02660138|143036951|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|10.99||||0.0003|TWO_SIDED|95.0|3.05|39.61|||GLMM|||Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||39.61|3.05|0.0003
71767585|NCT02660138|143036952|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|5.73||||0.001|TWO_SIDED|95.0|2.02|16.24|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||16.24|2.02|0.0010
71767586|NCT02660138|143036952|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|16.08|||<|0.0001|TWO_SIDED|95.0|5.82|44.43|||Regression, Logistic|||Treatment group, and recorded stratification factors (aetiology of NDO, previous BTX-A usage) and study baseline (prior intradetrusor BTX-A usage for UI) as explanatory variables.||44.43|5.82|<0.0001
71767587|NCT02660138|143036953|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|13.3||||0.0003|TWO_SIDED|95.0|6.22|20.37|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||20.37|6.22|0.0003
71767588|NCT02660138|143036953|SUPERIORITY|The secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|LS Mean Difference|17.25|||<|0.0001|TWO_SIDED|95.0|10.36|24.15|||MMRM|||Treatment group, visit (Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (I-QoL summary total score) as fixed variables, and subject as a random effect.||24.15|10.36|<0.0001
71715296|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.98|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.42|0.98|<0.001
71767589|NCT02660138|143036954|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|4.0||||0.0007|TWO_SIDED|95.0|1.8|8.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||8.86|1.80|0.0007
71767590|NCT02660138|143036954|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.63||||0.0012|TWO_SIDED|95.0|1.68|7.86||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||7.86|1.68|0.0012
71767591|NCT02660138|143036954|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.03|||<|0.0001|TWO_SIDED|95.0|3.56|18.09||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 600 U versus Placebo.||18.09|3.56|<0.0001
71886984|NCT00915343|143294325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Sign test|||||||<0.0001
71886985|NCT00915343|143294326|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-272.3||||0.0034|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0034
71886986|NCT01920711|143294327|SUPERIORITY||Rate Ratio|0.8698||||0.0587|TWO_SIDED|95.0|0.7526|1.0052||1-sided p-value 0.0294|Proportional Rates Model (LWYY)|Treatment as fixed-effect factor and stratified by region and with robust variance estimate.||Primary Composite Events||1.0052|0.7526|0.0587
71767592|NCT02660138|143036954|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|8.22|||<|0.0001|TWO_SIDED|95.0|3.66|18.47||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement Level: Dysport® 800 U versus Placebo||18.47|3.66|<0.0001
71767593|NCT02660138|143036954|OTHER|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|10.7|||<|0.0001|TWO_SIDED|95.0|4.59|24.95||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 600 U versus Placebo.||24.95|4.59|<0.0001
71767594|NCT02660138|143036954|SUPERIORITY|Treatment group, recorded stratification factors, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|12.63|||<|0.0001|TWO_SIDED|95.0|5.4|29.56||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement Level: Dysport® 800 U versus Placebo.||29.56|5.40|<0.0001
71767595|NCT02660138|143036955|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|84.81|||<|0.0001|TWO_SIDED|95.0|43.73|125.89|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||125.89|43.73|<0.0001
71767596|NCT02660138|143036955|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|110.57|||<|0.0001|TWO_SIDED|95.0|70.17|150.98|||MMRM|||Treatment group, visit (Week 2, Week 6 and Week 12), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||150.98|70.17|<0.0001
71767597|NCT00308581|143036958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.696||95.0|0.7|1.7||Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).|Regression, Logistic||Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).|With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.||1.7|0.7|0.696
71767598|NCT01247298|143037026|OTHER||Kaplan Meier Estimate|82.0|||||TWO_SIDED||||||||Kaplan Meier Estimates of Progression Free Survival (PFS)|||||
71767599|NCT01087788|143037037|SUPERIORITY_OR_OTHER||Difference in Percentages|33.7|||<|0.001|TWO_SIDED|95.0|22.8|44.6||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||44.6|22.8|<0.001
71767600|NCT01087788|143037037|SUPERIORITY_OR_OTHER||Difference in Percentages|27.6|||<|0.001|TWO_SIDED|95.0|16.5|38.7||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.7|16.5|<0.001
71767601|NCT01087788|143037038|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-10.64|STANDARD_ERROR_OF_MEAN|8.35|=|0.203|TWO_SIDED|95.0|-27.05|5.77||Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors \& BL mTSS score as a covariate|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the pre-defined primary analysis.||5.77|-27.05|=0.203
71775053|NCT01086423|143050305|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.||2.56|-2.51|
71886987|NCT01920711|143294327|SUPERIORITY||Rate Ratio|0.8511||||0.0556|TWO_SIDED|95.0|0.7216|1.0039||1-sided p-value 0.0278|Joint Frality Model|Treatment and region as fixed-effect factors||Total Hospitalizations for heart failure||1.0039|0.7216|0.0556
71886988|NCT01920711|143294327|SUPERIORITY||Hazard Ratio (HR)|0.9531||||0.6241|TWO_SIDED|95.0|0.7863|1.1551||1-sided p-value 0.3120|Cox's proportional hazard model|||Cardiovascular Death||1.1551|0.7863|0.6241
71886989|NCT01920711|143294328|SUPERIORITY||Least Squares Mean of Difference|1.0264||||0.051|TWO_SIDED|95.0|-0.0047|2.0576|||Mixed Models Analysis|||Clinical Summary Score||2.0576|-0.0047|0.0510
71886990|NCT01920711|143294329|SUPERIORITY||Odds Ratio (OR)|1.4475||||0.0035|TWO_SIDED|95.0|1.1294|1.8552|||Repeated measures cumulative odds model|The response variable is the change from baseline to any scheduled time points up to Month 8.||NYHA Class Change||1.8552|1.1294|0.0035
71886991|NCT01920711|143294330|SUPERIORITY||Hazard Ratio (HR)|0.5041||||0.0014|TWO_SIDED|95.0|0.3312|0.7673|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Composite renal endpoint||0.7673|0.3312|0.0014
71886992|NCT01920711|143294330|SUPERIORITY||Hazard Ratio (HR)|0.9295||||0.9588|TWO_SIDED|95.0|0.0581|14.861|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Renal Death||14.861|0.0581|0.9588
71661131|NCT03589768|142835866|SUPERIORITY||Ratio|0.7||||0.0022|TWO_SIDED|95.0|0.6|0.9|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.9|0.6|0.0022
71661132|NCT03589768|142835866|SUPERIORITY||Ratio|0.7||||0.0008|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|0.8|0.5|0.0008
71661133|NCT03589768|142835866|SUPERIORITY||Ratio|0.7||||0.0261|TWO_SIDED|95.0|0.5|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.5|0.0261
71661134|NCT03589768|142835866|SUPERIORITY||Ratio|0.6||||0.0532|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0532
71661135|NCT03589768|142835866|SUPERIORITY||Ratio|0.9||||0.5587|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.4|0.5|0.5587
71661136|NCT03589768|142835867|SUPERIORITY||Ratio|0.9||||0.5056|TWO_SIDED|95.0|0.6|1.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.3|0.6|0.5056
71661137|NCT03589768|142835867|SUPERIORITY||Ratio|1.0||||0.9466|TWO_SIDED|95.0|0.7|1.5|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.5|0.7|0.9466
71661138|NCT03589768|142835867|SUPERIORITY||Ratio|1.1||||0.6911|TWO_SIDED|95.0|0.6|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.6|0.6911
71661139|NCT03589768|142835867|SUPERIORITY||Ratio|0.6||||0.0952|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.3|0.0952
71661140|NCT03589768|142835867|SUPERIORITY||Ratio|1.2||||0.4134|TWO_SIDED|95.0|0.8|2.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.0|0.8|0.4134
71661141|NCT03589768|142835868|SUPERIORITY||Ratio|1.6||||0.0859|TWO_SIDED|95.0|0.9|2.6|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for birth time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.6|0.9|0.0859
71661142|NCT03589768|142835868|SUPERIORITY||Ratio|1.4||||0.204|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for prior to receipt of first dose of DTwP (approximately 6 weeks of age)|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.3|0.8|0.2040
71661143|NCT03589768|142835868|SUPERIORITY||Ratio|1.6||||0.0763|TWO_SIDED|95.0|1.0|2.7|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of first dose of DTwP (approximately 10 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|2.7|1.0|0.0763
71661144|NCT03589768|142835868|SUPERIORITY||Ratio|0.5||||0.0836|TWO_SIDED|95.0|0.2|1.1|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for one month after receipt of last dose of DTwP (approximately 18 weeks of age) time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.1|0.2|0.0836
71661145|NCT03589768|142835868|SUPERIORITY||Ratio|0.6||||0.0672|TWO_SIDED|95.0|0.3|1.0|||t-test, 2 sided|Test compares difference in log values.|Difference in log values back transformed into ratio.|Statistical analysis for 6 months of age time point|The ratio is calculated as the GMC of the BOOSTRIX group divided by the GMC of the Td group.|1.0|0.3|0.0672
71661146|NCT00191113|142835870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||<|0.001||95.0|0.7|1.1|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interaction terms removed when not significant.|"Effect direction is As-Randomized Humatrope minus As-Randomized Control"|This component of the primary analysis is inferential i.e. to ascertain definitively whether Humatrope treatment affects change in Height SDS (NCHS). Null hypothesis is no effect of Humatrope treatment.||1.1|0.7|<0.001
71767602|NCT01087788|143037038|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.09|=|0.017|TWO_SIDED|95.0|-0.38|-0.04||Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||-0.04|-0.38|=0.017
71767603|NCT01087788|143037038|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|=|0.261|TWO_SIDED|95.0|-0.27|0.07||Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)||0.07|-0.27|=0.261
71767604|NCT01087788|143037039|SUPERIORITY_OR_OTHER||Difference in Percentages|40.2|||<|0.001|TWO_SIDED|95.0|29.5|51.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||51.0|29.5|<0.001
71767605|NCT01087788|143037039|SUPERIORITY_OR_OTHER||Difference in Percentages|32.8|||<|0.001|TWO_SIDED|95.0|21.8|43.8||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||43.8|21.8|<0.001
71767606|NCT01087788|143037040|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.42|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.42|<0.001
71767607|NCT01087788|143037041|SUPERIORITY_OR_OTHER||Difference in Percentages|46.3|||<|0.001|TWO_SIDED|95.0|35.7|56.9||Difference of Certolizumab Pegol 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||56.9|35.7|<0.001
71775054|NCT01086423|143050305|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.||2.56|-2.51|
71828374|NCT02739035|143161318|SUPERIORITY|A difference of 10 degrees in total mean range of motion (ROM) between the control and the treatment group was considered a clinically significant improvement. To detect this difference, a previous study's mean and standard deviation were referenced in order to predict the variation of results. 54 patients per arm were required to have 90% power with a two-sided t-test and a type I error rate of 5%. 130 patients were targeted for recruitment to account for up to a 20% dropout rate.||||||0.81||||||Using a standard alpha value of 0.05, p values below 0.05 were considered statistically significant.|t-test, 2 sided|||"Outcomes were compared between the two study groups using two-sample t-tests. T-tests were two-sided and the standard alpha value of 0.05 was the threshold for statistical significance.~The null hypothesis was that there were no significant differences between control group of MUA alone and the treatment group of MUA with dexamethasone and celecoxib."||||0.81
71886993|NCT01920711|143294330|SUPERIORITY||Hazard Ratio (HR)|0.5774||||0.2484|TWO_SIDED|95.0|0.2272|1.4672|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||Reaching ESRD||1.4672|0.2272|0.2484
71886994|NCT01920711|143294330|SUPERIORITY||Hazard Ratio (HR)|0.4407||||0.0004|TWO_SIDED|95.0|0.2798|0.6942|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||\>=50% decline in eGFR from baseline||0.6942|0.2798|0.0004
71886995|NCT01920711|143294331|SUPERIORITY||Hazard Ratio (HR)|0.9696||||0.6846|TWO_SIDED|95.0|0.8352|1.1255|||Cox's proportional hazards model|Treatment as fixed factor and stratified by region.||All-cause mortality||1.1255|0.8352|0.6846
71886996|NCT03434379|143294345|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|||At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.79|0.42|0.0006
71715297|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
71715298|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
71715299|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.85|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|<0.001
71715300|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.82|<0.001
71715301|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.18|0.86|<0.001
71715302|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.23|0.90|<0.001
71715303|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.72|0.93||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|0.93|0.72|<0.001
71715304|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.01||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.01|0.79|<0.001
71715305|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.96|<0.001
71767608|NCT01087788|143037042|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|=|0.127|TWO_SIDED|95.0|-0.43|0.05||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the predefined analysis.||0.05|-0.43|=0.127
71767609|NCT01087788|143037042|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.26|=|0.048|TWO_SIDED|95.0|-1.04|-0.01||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the post-hoc analysis for the subgroup 'Baseline mTSS \> 6'.||-0.01|-1.04|=0.048
71767610|NCT00160667|143037043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||=|0.965|TWO_SIDED|95.0|-12.82|13.41|||ANCOVA||Estimated value is the difference of Least Square Means.|||13.41|-12.82|=0.965
71767611|NCT00160667|143037043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|||=|0.825|TWO_SIDED|95.0|-11.69|14.65|||ANCOVA||Estimated value is the difference of Least Square Means.|||14.65|-11.69|=0.825
71886997|NCT03434379|143294345|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0009|TWO_SIDED|95.0|0.52|0.85|||Log Rank|||At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).||0.85|0.52|0.0009
71767612|NCT01779219|143037059|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Fisher's exact test (two-tailed)|Fisher Exact|||||||1.0
71767613|NCT01779219|143037060|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
71715306|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.88|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|<0.001
71715307|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.85|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.12|0.85|<0.001
71715308|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|<0.001
71715309|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.81|<0.001
71715310|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.99|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|<0.001
71715311|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.05|1.43||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.43|1.05|<0.001
71715312|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.26|0.96|<0.001
71715313|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.0|1.31||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.31|1.00|<0.001
71715314|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|<0.001
71715315|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.02||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.02|0.79|<0.001
71767614|NCT01779219|143037061|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total length of hospital stay||||0.16
71767615|NCT01779219|143037061|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the preoperative hospital stay||||0.73
71767616|NCT01779219|143037061|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Length of the postoperative hospital stay||||1.0
71767617|NCT01779219|143037062|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total OR time||||<0.001
71767618|NCT01779219|143037062|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Time of preoperative preparations||||0.004
71767619|NCT01779219|143037062|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Time of the operation (skin-to-skin)"||||0.024
71767620|NCT00534313|143037070|SUPERIORITY_OR_OTHER||Difference|22.9||||0.022|TWO_SIDED|95.0|4.0|41.8||The p-value (two-sided) was based on Cochran-Mantel-Haenszel method (CMH) with stratification of baseline body surface area (BSA) affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||41.8|4.0|0.022
71767621|NCT00534313|143037070|SUPERIORITY_OR_OTHER||Difference|28.7||||0.006|TWO_SIDED|95.0|9.4|48.0||p-value (two-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||48.0|9.4|0.006
71767622|NCT00534313|143037070|SUPERIORITY_OR_OTHER||Difference|14.6||||0.121|TWO_SIDED|95.0|-3.5|32.6||p-value (2-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.|||32.6|-3.5|0.121
71767623|NCT00534313|143037077|SUPERIORITY_OR_OTHER||Difference|-6.0|||||TWO_SIDED|95.0|-23.0|11.0|||Cochran-Mantel-Haenszel||Difference and 95% confidence intervals (CI) was based on CMH with stratification of baseline BSA affected by psoriasis.|||11.0|-23.0|
71828375|NCT05819190|143161337|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - FAS set||||0.0192
71715316|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|<0.001
71715317|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.95|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.95|<0.001
71715318|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.81|1.05||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.05|0.81|<0.001
71715319|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.82|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|<0.001
71715320|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|<0.001
71715321|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.77|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.10|0.77|<0.001
71715322|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.87|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.24|0.87|<0.001
71715323|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.13|||<|0.001|TWO_SIDED|95.0|0.95|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.35|0.95|<0.001
71715324|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.81|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.11|0.81|<0.001
71715325|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|<0.001
71715326|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.88|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.21|0.88|<0.001
71715327|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 2|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2|GMT ratio and 95% CI were estimated from a cLDA model.|1.16|0.86|<0.001
71767624|NCT00534313|143037077|SUPERIORITY_OR_OTHER||Difference|-0.5|||||TWO_SIDED|95.0|-18.0|17.1|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||17.1|-18.0|
71828376|NCT05819190|143161338|SUPERIORITY|||||||0.0296|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean AUC of WURSS-21 scores assessed during the first 8 days of the study between both groups - PP set||||0.0296
71828377|NCT05819190|143161339|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||||||0.0085
71828378|NCT05819190|143161340|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||||||0.0081
71828379|NCT05819190|143161341|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.0050
71828380|NCT05819190|143161342|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||||||0.0107
71828381|NCT05819190|143161343|SUPERIORITY|||||||0.0424|||||||Wilcoxon (Mann-Whitney)|||||||0.0424
71715328|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.91|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 1 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.91|<0.001
71715329|NCT03950856|142946221|EQUIVALENCE|Lower and upper p-values ≤ 0.025 support a conclusion of equivalence.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.9|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P-value for the comparison of the GMT ratio to the lower bound (0.5). P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3|GMT ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|<0.001
71715330|NCT03950856|142946222|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 2|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
71715331|NCT03950856|142946222|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Lot 1 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.17|0.89|
71715332|NCT03950856|142946222|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
71715333|NCT03950856|142946222|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||Lot 1 divided by Lot 2|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.77|
71715334|NCT03950856|142946222|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||Lot 1 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.91|
71715335|NCT03950856|142946222|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.06|1.32|||||Lot 2 divided by Lot 3|Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.32|1.06|
71715336|NCT03950856|142946222|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.94|||||Lot 1 divided by Lot 2|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.72|
71715337|NCT03950856|142946222|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.23|||||Lot 1 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.94|
71715338|NCT03950856|142946222|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.5||||P-value for the comparison of the GMT ratio to the upper bound (2.0).|Lot 2 divided by Lot 3|Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.50|1.14|
71715339|NCT03950856|142946222|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.95|||||Lot 1 divided by Lot 2|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.95|0.72|
71715340|NCT03950856|142946222|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11|||||Lot 1 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.84|
71767625|NCT00534313|143037077|SUPERIORITY_OR_OTHER||Difference|10.4|||||TWO_SIDED|95.0|-7.6|28.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||28.5|-7.6|
71715341|NCT03950856|142946222|OTHER||GMC Ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35|||||Lot 2 divided by Lot 3|Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.02|
71715342|NCT03950856|142946222|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.07|||||Lot 1 divided by Lot 2|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.78|
71767626|NCT00534313|143037078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.77|||||TWO_SIDED|95.0|-7.02|44.56|||ANCOVA|||||44.56|-7.02|
71767627|NCT00534313|143037078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.34|||||TWO_SIDED|95.0|-3.93|48.6|||ANCOVA|||||48.60|-3.93|
71767628|NCT00534313|143037078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.48|||||TWO_SIDED|95.0|4.82|56.15|||ANCOVA|||||56.15|4.82|
71767629|NCT00534313|143037080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.08||||||95.0|-4.79|8.96|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.96|-4.79|
71715343|NCT03950856|142946222|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||Lot 1 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.16|0.85|
71715344|NCT03950856|142946222|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.27|||||Lot 2 divided by Lot 3|Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.93|
71715345|NCT03950856|142946222|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||Lot 1 divided by Lot 2|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
71715346|NCT03950856|142946222|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
71715347|NCT03950856|142946222|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.94|1.28|||||Lot 2 divided by Lot 3|Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.28|0.94|
71715348|NCT03950856|142946222|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.92|||||Lot 1 divided by Lot 2|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|0.92|0.70|
71715349|NCT03950856|142946222|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||Lot 1 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
71715350|NCT03950856|142946222|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.04|1.37|||||Lot 2 divided by Lot 3|Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.37|1.04|
71715351|NCT03950856|142946222|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08|||l||Lot 1 divided by Lot 2|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.83|
71715352|NCT03950856|142946222|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||Lot 1 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71767630|NCT00534313|143037080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|||||TWO_SIDED|95.0|-4.94|8.95|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||8.95|-4.94|
71715353|NCT03950856|142946222|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.19|||||Lot 2 divided by Lot 3|Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.19|0.91|
71715354|NCT03950856|142946222|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0|||||Lot 1 divided by Lot 2|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.75|
71715355|NCT03950856|142946222|OTHER||GMC Ratio|1.13|||||TWO_SIDED|95.0|0.98|1.31|||||Lot 1 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.31|0.98|
71715356|NCT03950856|142946222|OTHER||GMC Ratio|1.31|||||TWO_SIDED|95.0|1.14|1.52|||||Lot 2 divided by Lot 3|Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.52|1.14|
71715357|NCT03950856|142946222|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|1.04|1.36|||||Lot 1 divided by Lot 2|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.36|1.04|
71715358|NCT03950856|142946222|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.15|1.51|||||Lot 1 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.15|
71715359|NCT03950856|142946222|OTHER||GMC Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.27|||||Lot 2 divided by Lot 3|Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.27|0.97|
71715360|NCT03950856|142946222|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||Lot 1 divided by Lot 2|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.02|0.78|
71715361|NCT03950856|142946222|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||Lot 1 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.11|0.86|
71715362|NCT03950856|142946222|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.25|||||Lot 2 divided by Lot 3|Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.25|0.96|
71715363|NCT03950856|142946222|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|1.0|||||Lot 1 divided by Lot 2|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.00|0.76|
71715364|NCT03950856|142946222|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||Lot 1 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
71715365|NCT03950856|142946222|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.92|1.21|||||Lot 2 divided by Lot 3|Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.21|0.92|
71715366|NCT03950856|142946222|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.07|||||Lot 1 divided by Lot 2|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.80|
71767631|NCT00534313|143037080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-6.08|7.58|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||7.58|-6.08|
71715367|NCT03950856|142946222|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Lot 1 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
71715368|NCT03950856|142946222|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||Lot 2 divided by Lot 3|Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.24|0.93|
71715369|NCT03950856|142946222|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||Lot 1 divided by Lot 2|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.08|0.81|
71715370|NCT03950856|142946222|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.93|1.26|||||Lot 1 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.26|0.93|
71715371|NCT03950856|142946222|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||Lot 2 divided by Lot 3|Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.35|1.00|
71715372|NCT03950856|142946222|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||Lot 1 divided by Lot 2|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 2|GMC ratio and 95% CI were estimated from a cLDA model.|1.06|0.79|
71715373|NCT03950856|142946222|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.22|||||Lot 1 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.22|0.90|
71715374|NCT03950856|142946222|OTHER||GMC Ratio|1.15|||||TWO_SIDED|95.0|0.99|1.34|||||Lot 2 divided by Lot 3|Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 3|GMC ratio and 95% CI were estimated from a cLDA model.|1.34|0.99|
71715375|NCT03950856|142946223|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.62|0.91|||||V114 Combined Lots divided by Prevnar 13™|Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.91|0.62|
71715376|NCT03950856|142946223|OTHER||GMC Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||V114 Combined Lots divided by Prevnar 13™|Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.61|1.20|
71715377|NCT03950856|142946223|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94|||||V114 Combined Lots divided by Prevnar 13™|Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|0.94|0.66|
71715378|NCT03950856|142946223|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||||V114 Combined Lots divided by Prevnar 13™|Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.07|0.74|
71715379|NCT03950856|142946223|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.95|1.43|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.43|0.95|
71715380|NCT03950856|142946223|OTHER||GMC Ratio|1.5|||||TWO_SIDED|95.0|1.21|1.86|||||V114 Combined Lots divided by Prevnar 13™|Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.86|1.21|
71715381|NCT03950856|142946223|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.73|
71715382|NCT03950856|142946223|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.04|||||V114 Combined Lots divided by Prevnar 13™|Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.04|0.72|
71715383|NCT03950856|142946223|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||||V114 Combined Lots divided by Prevnar 13™|Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.20|0.82|
71715384|NCT03950856|142946223|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.05|1.51|||||V114 Combined Lots divided by Prevnar 13™|Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.51|1.05|
71715385|NCT03950856|142946223|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.82|1.15|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.15|0.82|
71715386|NCT03950856|142946223|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.86|1.23|||||V114 Combined Lots divided by Prevnar 13™|Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.23|0.86|
71715387|NCT03950856|142946223|OTHER||GMC Ratio|1.26|||||TWO_SIDED|95.0|1.03|1.54|||||V114 Combined Lots divided by Prevnar 13™|Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|1.54|1.03|
71715388|NCT03950856|142946223|OTHER||GMC Ratio|12.21|||||TWO_SIDED|95.0|10.11|14.74|||||V114 Combined Lots divided by Prevnar 13™|Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|14.74|10.11|
71715389|NCT03950856|142946223|OTHER||GMC Ratio|9.42|||||TWO_SIDED|95.0|7.96|11.13|||||V114 Combined Lots divided by Prevnar 13™|Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™|GMC ratio and 95% CI were estimated from a cLDA model.|11.13|7.96|
71715390|NCT01732536|142946298|SUPERIORITY|||||||0.1365|||||||ANCOVA|Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.1365
71715391|NCT01732536|142946298|SUPERIORITY|||||||0.0505||||||Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|ANCOVA|||The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).||||0.0505
71715392|NCT01732536|142946299|SUPERIORITY|||||||0.0985|||||||ANCOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||||||0.0985
71715393|NCT01732536|142946299|SUPERIORITY|||||||0.049|||||||ANOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)||||0.0490
71715394|NCT01732536|142946300|SUPERIORITY|||||||0.0099|||||||ANCOVA|||||||0.0099
71715395|NCT01732536|142946301|SUPERIORITY|||||||0.0162||||||P-value for change from baseline to 90 days not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0162
71715396|NCT01732536|142946301|SUPERIORITY|||||||0.0175||||||P-value for change from baseline to 6 months not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0175
71715397|NCT01732536|142946302|SUPERIORITY|||||||0.0209||||||P-value not adjusted for multiplicity.|ANCOVA|Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects||||||0.0209
71715398|NCT03235050|142946333|SUPERIORITY||LS Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.59|||ANCOVA|||||-0.59|-1.06|<0.001
71715399|NCT03235050|142946333|SUPERIORITY||LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.23|-0.85|||ANCOVA|||||-0.85|-1.23|<0.001
71715400|NCT03235050|142946333|SUPERIORITY||LS Mean Difference|-0.91|||<|0.001|TWO_SIDED|95.0|-1.11|-0.72|||ANCOVA|||||-0.72|-1.11|<0.001
71715401|NCT03235050|142946334|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-3.08|-0.91|||ANCOVA|||||-0.91|-3.08|<0.001
71715402|NCT03235050|142946334|SUPERIORITY||LS Mean Difference|-2.76|||<|0.001|TWO_SIDED|95.0|-3.65|-1.87|||ANCOVA|||||-1.87|-3.65|<0.001
71715403|NCT03235050|142946334|SUPERIORITY||LS Mean Difference|-3.62|||<|0.001|TWO_SIDED|95.0|-4.51|-2.73|||ANCOVA|||||-2.73|-4.51|<0.001
71715404|NCT03235050|142946335|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.92|-0.4|||ANCOVA|||Week 26||-0.40|-0.92|<0.001
71715405|NCT03235050|142946335|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.03|-0.6|||ANCOVA|||Week 26||-0.60|-1.03|<0.001
71715406|NCT03235050|142946335|SUPERIORITY||LS Mean Difference|-0.72|||<|0.001|TWO_SIDED|95.0|-0.94|-0.51|||ANCOVA|||Week 26||-0.51|-0.94|<0.001
71715407|NCT03235050|142946335|SUPERIORITY||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||ANCOVA|||Week 54||-0.24|-0.80|<0.001
71715408|NCT03235050|142946335|SUPERIORITY||LS Mean Difference|-0.63|||<|0.001|TWO_SIDED|95.0|-0.86|-0.39|||ANCOVA|||Week 54||-0.39|-0.86|<0.001
71715409|NCT03235050|142946335|SUPERIORITY||LS Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.8|-0.34|||ANCOVA|||Week 54||-0.34|-0.80|<0.001
71715410|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|6.67|||<|0.001|TWO_SIDED|92.0|3.34|13.3|||Regression, Logistic|||Week 14||13.30|3.34|<0.001
71715411|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|9.95|||<|0.001|TWO_SIDED|95.0|5.39|18.36|||Regression, Logistic|||Week 14||18.36|5.39|<0.001
71715412|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|8.52|||<|0.001|TWO_SIDED|95.0|4.65|15.61|||Regression, Logistic|||Week 14||15.61|4.65|<0.001
71715413|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|3.74|||<|0.001|TWO_SIDED|95.0|1.98|7.03|||Regression, Logistic|||Week 26||7.03|1.98|<0.001
71715414|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|5.4|||<|0.001|TWO_SIDED|95.0|3.13|9.34|||Regression, Logistic|||Week 26||9.34|3.13|<0.001
71715415|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|5.2|||<|0.001|TWO_SIDED|95.0|3.02|8.97|||Regression, Logistic|||Week 26||8.97|3.02|<0.001
71715416|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|4.94|||<|0.001|TWO_SIDED|95.0|2.61|9.36|||Regression, Logistic|||Week 54||9.36|2.61|<0.001
71715417|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|4.55|||<|0.001|TWO_SIDED|95.0|2.62|7.89|||Regression, Logistic|||Week 54||7.89|2.62|<0.001
71715418|NCT03235050|142946336|SUPERIORITY||Odds Ratio, log|4.34|||<|0.001|TWO_SIDED|95.0|2.51|7.51|||Regression, Logistic|||Week 54||7.51|2.51|<0.001
71715419|NCT03235050|142946337|SUPERIORITY||LS Mean Difference|-2.09|||<|0.001|TWO_SIDED|95.0|-3.32|-0.85|||ANCOVA|||Week 26||-0.85|-3.32|<0.001
71715420|NCT03235050|142946337|SUPERIORITY||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.82|-1.79|||ANCOVA|||Week 26||-1.79|-3.82|<0.001
71715421|NCT03235050|142946337|SUPERIORITY||LS Mean Difference|-3.46|||<|0.001|TWO_SIDED|95.0|-4.48|-2.44|||ANCOVA|||Week 26||-2.44|-4.48|<0.001
71715422|NCT03235050|142946337|SUPERIORITY||LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.86|-1.0|||ANCOVA|||Week 54||-1.00|-3.86|<0.001
71828382|NCT05819190|143161344|SUPERIORITY|||||||0.43||||||one sided test|Wilcoxon (Mann-Whitney)|||0.05 global significance level (type I error rate)||||0.430
71828383|NCT05819190|143161345|SUPERIORITY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.339
71828384|NCT05819190|143161346|SUPERIORITY|||||||0.704|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.704
71828385|NCT05819190|143161347|SUPERIORITY|||||||0.298|||||||Wilcoxon (Mann-Whitney)|One sided test||0.05 global significance level (type I error rate)||||0.298
71828386|NCT05819190|143161348|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.906
71828387|NCT05819190|143161349|SUPERIORITY|||||||0.582|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.582
71828388|NCT05819190|143161350|SUPERIORITY|||||||0.743|||||||Wilcoxon (Mann-Whitney)|one sided test||0.05 global significance level (type I error rate)||||0.743
71886998|NCT03434379|143294346|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.47|<0.0001
71715423|NCT03235050|142946337|SUPERIORITY||LS Mean Difference|-2.24|||<|0.001|TWO_SIDED|95.0|-3.41|-1.06|||ANCOVA|||Week 54||-1.06|-3.41|<0.001
71715424|NCT03235050|142946337|SUPERIORITY||LS Mean Difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.49|-2.14|||ANCOVA|||Week 54||-2.14|-4.49|<0.001
71715425|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-1.95|||<|0.001|TWO_SIDED|95.0|-3.03|-0.87|||ANCOVA|||Week 14||-0.87|-3.03|<0.001
71715426|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-2.75|||<|0.001|TWO_SIDED|95.0|-3.63|-1.86|||ANCOVA|||Week 14||-1.86|-3.63|<0.001
71715427|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-3.71|||<|0.001|TWO_SIDED|95.0|-4.6|-2.82|||ANCOVA|||Week 14||-2.82|-4.60|<0.001
71715428|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-2.01||||0.002|TWO_SIDED|95.0|-3.27|-0.74|||ANCOVA|||Week 26||-0.74|-3.27|0.002
71715429|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.78|-1.71|||ANCOVA|||Week 26||-1.71|-3.78|<0.001
71715430|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-3.55|||<|0.001|TWO_SIDED|95.0|-4.59|-2.52|||ANCOVA|||Week 26||-2.52|-4.59|<0.001
71715431|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-2.27||||0.003|TWO_SIDED|95.0|-3.74|-0.79|||ANCOVA|||Week 54||-0.79|-3.74|0.003
71715432|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-2.16|||<|0.001|TWO_SIDED|95.0|-3.37|-0.95|||ANCOVA|||Week 54||-0.95|-3.37|<0.001
71715433|NCT03235050|142946338|SUPERIORITY||LS Mean Difference|-3.42|||<|0.001|TWO_SIDED|95.0|-4.63|-2.2|||ANCOVA|||Week 54||-2.20|-4.63|<0.001
71715434|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|0.7||||0.211|TWO_SIDED|95.0|-0.39|1.79|||ANCOVA|||Percent change at Week 14||1.79|-0.39|0.211
71715435|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|-0.07||||0.881|TWO_SIDED|95.0|-0.96|0.83|||ANCOVA|||Percent change at Week 14||0.83|-0.96|0.881
71715436|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|-0.93||||0.042|TWO_SIDED|95.0|-1.82|-0.04|||ANCOVA|||Percent change at Week 14||-0.04|-1.82|0.042
71715437|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|0.9||||0.158|TWO_SIDED|95.0|-0.35|2.14|||ANCOVA|||Percent change at Week 26||2.14|-0.35|0.158
71715438|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|0.18||||0.734|TWO_SIDED|95.0|-0.85|1.2|||ANCOVA|||Percent change at Week 26||1.20|-0.85|0.734
71767632|NCT00534313|143037084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||||TWO_SIDED|95.0|1.97|12.33|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as factor and baseline value as covariate was used for the analysis.||||12.33|1.97|
71886999|NCT03434379|143294347|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0026|TWO_SIDED|95.0|0.25|0.76|||Log Rank|||At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.76|0.25|0.0026
71887000|NCT03434379|143294347|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0019|TWO_SIDED|95.0|0.35|0.8|||Log Rank|||At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.80|0.35|0.0019
71715439|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|-0.48||||0.357|TWO_SIDED|95.0|-1.51|0.54|||ANCOVA|||Percent change at Week 26||0.54|-1.51|0.357
71715440|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|-0.07||||0.921|TWO_SIDED|95.0|-1.51|1.37|||ANCOVA|||Percent change at Week 54||1.37|-1.51|0.921
71715441|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|0.12||||0.847|TWO_SIDED|95.0|-1.07|1.3|||ANCOVA|||Percent change at Week 54||1.30|-1.07|0.847
71715442|NCT03235050|142946339|SUPERIORITY||LS Mean Difference|-0.96||||0.112|TWO_SIDED|95.0|-2.15|0.22|||ANCOVA|||Percent change at Week 54||0.22|-2.15|0.112
71715443|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|0.59||||0.284|TWO_SIDED|95.0|-0.49|1.68|||ANCOVA|||Absolute change at Week 14||1.68|-0.49|0.284
71715444|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-0.2||||0.658|TWO_SIDED|95.0|-1.09|0.69|||ANCOVA|||Absolute change at Week 14||0.69|-1.09|0.658
71715445|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-1.17||||0.01|TWO_SIDED|95.0|-2.06|-0.27|||ANCOVA|||Absolute change at Week 14||-0.27|-2.06|0.010
71715446|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|0.7||||0.279|TWO_SIDED|95.0|-0.57|1.97|||ANCOVA|||Absolute change at Week 26||1.97|-0.57|0.279
71828389|NCT05819190|143161351|SUPERIORITY|||||||0.605|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.605
71828390|NCT05819190|143161352|SUPERIORITY|||||||1|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||1.000
71828391|NCT05819190|143161353|SUPERIORITY|||||||0.988|||||||Fisher Exact|One sided test||0.05 global significance level (type I error rate)||||0.988
71828392|NCT05819190|143161354|SUPERIORITY|||||||0.483|||||||Fisher Exact|one sided test||0.05 global significance level (type I error rate)||||0.483
71828393|NCT02517307|143161355|OTHER|||||||0.136|||||||Mixed Models Analysis|||We compared the effects of intralipid on Rd in controls subjects versus subjects with a FAOD by mixed-effect models. Factors were group (control or FAOD) treatment (glycerol or intralipid) and the interaction of those factors. The hypothesis was intralipid would decrease Rd in controls but not in subjects with an FAOD.||||0.136
71715447|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-0.04||||0.94|TWO_SIDED|95.0|-1.08|1.0|||ANCOVA|||Absolute change at Week 26||1.00|-1.08|0.940
71828394|NCT02517307|143161356|OTHER|We analyzed the data with a mixed model looking at the effect of group (control vs FAOD) and treatment (glycerol vs intralipid) and their interaction.||||||0.011|||||||Mixed Models Analysis|||We tested if intralipid did not suppress endogenous glucose production or Ra as much as glycerol in controls compared to subjects with an FAOD.||||0.011
71828395|NCT01212757|143161362|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.4||||0.006|TWO_SIDED|95.0|4.0|22.7|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||22.7|4.0|0.0060
71715448|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-0.85||||0.11|TWO_SIDED|95.0|-1.89|0.19|||ANCOVA|||Absolute change at Week 26||0.19|-1.89|0.110
71715449|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-0.26||||0.73|TWO_SIDED|95.0|-1.74|1.22|||ANCOVA|||Absolute change at Week 54||1.22|-1.74|0.730
71715450|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-0.15||||0.804|TWO_SIDED|95.0|-1.38|1.07|||ANCOVA|||Absolute change at Week 54||1.07|-1.38|0.804
71715451|NCT03235050|142946340|SUPERIORITY||LS Mean Difference|-1.41||||0.023|TWO_SIDED|95.0|-2.63|-0.19|||ANCOVA|||Absolute change at Week 54||-0.19|-2.63|0.023
71715452|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|8.37|||<|0.001|TWO_SIDED|95.0|2.38|29.43|||Regression, Logistic|||weight loss \>=5% at Week 14||29.43|2.38|<0.001
71767633|NCT00534313|143037084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.12|||||TWO_SIDED|95.0|3.83|14.41|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis||||14.41|3.83|
71767634|NCT00534313|143037084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.17|||||TWO_SIDED|95.0|1.01|11.32|||ANCOVA|ANCOVA model with treatment as factor and baseline value as covariate was used for the analysis.||||11.32|1.01|
71715453|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|12.46|||<|0.001|TWO_SIDED|95.0|3.82|40.64|||Regression, Logistic|||weight loss \>=5% at Week 14||40.64|3.82|<0.001
71715454|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|21.26|||<|0.001|TWO_SIDED|95.0|6.55|68.97|||Regression, Logistic|||weight loss \>=5% at Week 14||68.97|6.55|<0.001
71715455|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|3.68|||<|0.001|TWO_SIDED|95.0|1.72|7.89|||Regression, Logistic|||weight loss \>=5% at Week 26||7.89|1.72|<0.001
71767635|NCT00534313|143037085|SUPERIORITY_OR_OTHER||Difference|16.0|||||TWO_SIDED|95.0|-2.5|34.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.5|-2.5|
71715456|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|3.95|||<|0.001|TWO_SIDED|95.0|2.0|7.78|||Regression, Logistic|||weight loss \>=5% at Week 26||7.78|2.00|<0.001
71715457|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|7.28|||<|0.001|TWO_SIDED|95.0|3.72|14.24|||Regression, Logistic|||weight loss \>=5% at Week 26||14.24|3.72|<0.001
71715458|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|3.71|||<|0.001|TWO_SIDED|95.0|1.84|7.45|||Regression, Logistic|||weight loss \>=5% at Week 54||7.45|1.84|<0.001
71715459|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|2.73||||0.002|TWO_SIDED|95.0|1.46|5.09|||Regression, Logistic|||weight loss \>=5% at Week 54||5.09|1.46|0.002
71715460|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|4.48|||<|0.001|TWO_SIDED|95.0|2.42|8.3|||ANCOVA|||weight loss \>=5% at Week 54||8.30|2.42|<0.001
71715461|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|8.47||||0.048|TWO_SIDED|95.0|1.02|70.17|||Regression, Logistic|||weight loss \>=10% at Week 26||70.17|1.02|0.048
71715462|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|13.81||||0.01|TWO_SIDED|95.0|1.85|102.91|||Regression, Logistic|||weight loss \>=10% at Week 26||102.91|1.85|0.010
71715463|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|13.09||||0.012|TWO_SIDED|95.0|1.75|97.68|||Regression, Logistic|||weight loss \>=10% at Week 26||97.68|1.75|0.012
71715464|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|6.92||||0.013|TWO_SIDED|95.0|1.49|32.07|||Regression, Logistic|||weight loss \>=10% at Week 54||32.07|1.49|0.013
71715465|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|4.98||||0.032|TWO_SIDED|95.0|1.15|21.6|||Regression, Logistic|||weight loss \>=10% at Week 54||21.60|1.15|0.032
71715466|NCT03235050|142946341|SUPERIORITY||Odds Ratio, log|7.91||||0.005|TWO_SIDED|95.0|1.86|33.64|||Regression, Logistic|||weight loss \>=10% at Week 54||33.64|1.86|0.005
71767636|NCT00534313|143037085|SUPERIORITY_OR_OTHER||Difference|26.1||||||95.0|6.8|45.5|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||45.5|6.8|
71715467|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.09||||0.024|TWO_SIDED|95.0|0.01|0.73|||Regression, Logistic|||received rescue medication at 14 wks||0.73|0.01|0.024
71715468|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.03|0.4|||Regression, Logistic|||received rescue medication at 14 wks||0.40|0.03|<0.001
71715469|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.33|||Regression, Logistic|||received rescue medication at 14 wks||0.33|0.02|<0.001
71715470|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.14||||0.002|TWO_SIDED|95.0|0.04|0.48|||Regression, Logistic|||received rescue medication at 26 wks||0.48|0.04|0.002
71715471|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.34|||Regression, Logistic|||received rescue medication at 26 wks||0.34|0.06|<0.001
71715472|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.28|||Regression, Logistic|||received rescue medication at 26 wks||0.28|0.04|<0.001
71715473|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.11|0.53|||Regression, Logistic|||received rescue medication at 54 wks||0.53|0.11|<0.001
71715474|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.24|||<|0.001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||received rescue medication at 54 wks||0.44|0.13|<0.001
71715475|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.41|||Regression, Logistic|||received rescue medication at 54 wks||0.41|0.12|<0.001
71715476|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.22||||0.216|TWO_SIDED|95.0|0.02|2.43|||Regression, Logistic|||discontinued IP at 14 wks||2.43|0.02|0.216
71715477|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.28||||0.253|TWO_SIDED|95.0|0.03|2.52|||Regression, Logistic|||discontinued IP at 26 wks||2.52|0.03|0.253
71715478|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.21||||0.079|TWO_SIDED|95.0|0.04|1.19|||Regression, Logistic|||discontinued IP at 26 wks||1.19|0.04|0.079
71715479|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.27||||0.252|TWO_SIDED|95.0|0.03|2.5|||Regression, Logistic|||discontinued IP at 54 wks||2.50|0.03|0.252
71715480|NCT03235050|142946342|SUPERIORITY||Odds Ratio, log|0.32||||0.143|TWO_SIDED|95.0|0.07|1.47|||Regression, Logistic|||discontinued IP at 54 wks||1.47|0.07|0.143
71715481|NCT02415556|142946346|OTHER|"A spatial power variance-covariance structure was used to model within-subject correlated measurements where the number of days from the baseline visit was used as the power of the autoregressive correlation coefficient. Each efficacy and safety outcome variable was modeled separately.~The independent variables included: 4 treatment groups, TIMEG (baseline, on-treatment and post-treatment period), TIMEG \* treatment group.; an average number of treatment days; subjects as random effects."|Mean Difference (Final Values)|6.52||||0.025|TWO_SIDED|95.0|0.81|12.23||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||12.23|0.81|0.025
71767637|NCT00534313|143037085|SUPERIORITY_OR_OTHER||Difference|16.6||||||95.0|-1.8|34.9|||Cochran-Mantel-Haenszel||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.|||34.9|-1.8|
71715482|NCT02415556|142946346|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|5.28||||0.051|TWO_SIDED|95.0|-0.03|10.6||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||10.60|-0.03|0.051
71715483|NCT02415556|142946347|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|8.31||||0.007|TWO_SIDED|95.0|2.33|14.29||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||14.29|2.33|0.007
71715484|NCT02415556|142946347|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|2.71||||0.342|TWO_SIDED|95.0|-2.9|8.32||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||8.32|-2.90|0.342
71715485|NCT02415556|142946348|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.37||||0.144|TWO_SIDED|95.0|-0.87|0.13||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.13|-0.87|0.144
71715486|NCT02415556|142946348|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|-0.64||||0.008|TWO_SIDED|95.0|-1.11|-0.16||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||-0.16|-1.11|0.008
71767638|NCT02282293|143037146|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61||Calculated p-value|Chi-squared|||||7.61|0.50|0.50
71767639|NCT02282293|143037148|OTHER||Risk Ratio (RR)|1.96||||0.5|TWO_SIDED|95.0|0.5|7.61|||Chi-squared|||||7.61|0.50|0.50
71767640|NCT02282293|143037150|OTHER||Risk Ratio (RR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.48||Calculated p-value|GEE|||||1.48|0.13|0.19
71715487|NCT02415556|142946349|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.149|TWO_SIDED|95.0|-0.13|0.83||Mixed model p-value represents on-treatment difference between between Type 2 Diabetes Mellitus - Insulin vs. Type 2 Diabetes Mellitus - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.83|-0.13|0.149
71767641|NCT02282293|143037151|OTHER||Risk Ratio (RR)|1.33||||0.35|TWO_SIDED|95.0|0.72|2.45|||Chi-squared|||||2.45|0.72|0.35
71767642|NCT03381729|143037165|SUPERIORITY||Difference in Percent|-6.0|||>|0.9999|TWO_SIDED|95.0|-21.8|22.8|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to stand alone.|Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 7 (13.7%) participants achieved the ability to stand alone and 44 (86.3%) participants did not achieve the ability to stand alone.|22.8|-21.8|>0.9999
71767643|NCT03381729|143037166|SUPERIORITY||Difference Between Least Squares Mean|5.5||||0.0027|TWO_SIDED|95.0|1.9|9.0|||Mixed-Model Repeat Measure||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where the least squares mean (95% confidence interval) of the change from baseline in HFMSE scores at 12 months was 0.5 (-2.2 to 3.2).|9.0|1.9|0.0027
71767644|NCT03381729|143037168|SUPERIORITY||Percentage Difference|-2.1|||>|0.9999|TWO_SIDED|95.0|-17.2|27.0|||Fisher Exact|||Difference in the percentage of participants who achieved the ability to walk alone.|Data for the current study were compared to historical control data (Finkel et al 2014 PubMed 25080519) where 5 (9.8%) participants achieved the ability to walk alone and 46 (90.2%) participants did not achieve the ability to walk alone.|27.0|-17.2|>0.9999
71767645|NCT03758755|143037170|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.0219|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in IKDC score at 12 weeks post-op.||||0.0219
71767646|NCT03758755|143037171|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.008|||||||t-test, 1 sided|||Null hypothesis: there is no difference between groups in VAS score at 12 weeks post-op.||||0.008
71767647|NCT03758755|143037172|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.011|||||||t-test, 1 sided|||This analysis compares the change over time in quadriceps tendon strength between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in quadriceps tendon strength over time.||||0.011
71767648|NCT03758755|143037173|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.223|||||||t-test, 1 sided|||This analysis compares the change over time in thigh circumference between the BFR Therapy group and the No BFR Group. Underlying data was collected on a biweekly basis as the percent difference of the operated knee compared to the contralateral side. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in thigh circumference over time.||||0.223
71767649|NCT03758755|143037174|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.242|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee flexion between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee flexion over time.||||0.242
71767650|NCT03758755|143037175|EQUIVALENCE|The a priori threshold for statistical significance was set at 0.05.||||||0.049|||||||t-test, 1 sided|||This analysis compares the change over time in degrees of knee extension between the BFR Therapy group and the No BFR Group from 2 weeks post-op to 12 weeks post-op. Underlying data was collected on a biweekly basis. This statistical test utilized the null hypothesis that there would be no difference between groups in the change in degrees of knee extension over time.||||0.049
71767651|NCT00906971|143037193|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of defecations was recorded.|||||<|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||<0.05
71767652|NCT00906971|143037194|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of fecal incontinence was recorded reported at the beginning of the study|||||>|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.||||||>0.05
71767653|NCT01634191|143037214|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.2|135.0|||||Geometric mean ratio (Elderly/Young) and 90% confidence interval (CI) of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.2|
71887001|NCT03434379|143294348|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0117|TWO_SIDED|95.0|0.4|0.9|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.40|0.0117
71767654|NCT01634191|143037216|OTHER||Geometric Mean Ratio|128.0|||||TWO_SIDED|90.0|107.0|154.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-t. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||154|107|
71767655|NCT01634191|143037217|OTHER||Geometric Mean Ratio|113.0|||||TWO_SIDED|90.0|94.1|135.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of variance (ANOVA) model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||135|94.1|
71767656|NCT01634191|143037218|OTHER||Geometric Mean Ratio|131.0|||||TWO_SIDED|90.0|109.0|157.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed AUC0-∞. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||157|109|
71767657|NCT01634191|143037219|OTHER||Geometric Mean Ratio|106.0|||||TWO_SIDED|90.0|90.5|123.0|||||Geometric mean ratio (Elderly/Young) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of age on the PK of apremilast after a single 30 mg dose, a 2-way analysis of ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||123|90.5|
71767658|NCT01634191|143037220|OTHER||Geometric Mean Ratio|108.0|||||TWO_SIDED|90.0|92.3|126.0|||||Geometric mean ratio (Female/Male) and 90% CI of the ratio calculated from a 2-way ANOVA model, and presented as percentages.|To assess the effect of sex on the PK of apremilast after a single 30 mg dose, a 2-way ANOVA model was performed on the log-transformed Cmax. The ANOVA model included age group (elderly and young), sex (male and female), and age group by sex as a fixed effect.||126|92.3|
71767659|NCT01634191|143037221|OTHER||Median Difference|0.5||||0.153|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Elderly - Young) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.153
71767660|NCT01634191|143037222|OTHER||Median Difference|0.5||||0.169|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test||Median difference (Female - Male) and 90% CI of the difference calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.000|0.169
71715488|NCT02415556|142946349|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.8||Mixed model p-value represents on-treatment difference between between Control - Insulin vs. Control - Placebo.|Mixed Models Analysis|||We set type-I error rate at 0.05, power of 0.80 or above, effect size of 15% improvement due to INI, and obtained n=120 for the DM group (60 DM-INI; 60 DM-Placebo) and n=90 for the Control group (45 Control-INI; 45 Control-Placebo) yielding 210 patients with data at the end of the treatment period.||0.80|-0.11|0.134
71715489|NCT02415556|142946350|OTHER|The independent variables in the model included a four-level indicator variable for the four treatment groups, a three-level time indicator variable (TIMEG) representing baseline, on-treatment and post-treatment period and an interaction term between TIMEG and treatment group. An average number of treatment days at each assessment visit was used as a continuous repeated variable and subjects were included as random effects. Each efficacy and safety outcome variable was modeled separately.|Mean Difference (Final Values)|10.29||||0.03|TWO_SIDED|95.0|1.0|19.58|||Mixed Models Analysis|||||19.58|1.00|0.030
71715490|NCT02415556|142946350|OTHER|See primary aims.|Mean Difference (Final Values)|2.21||||0.607|TWO_SIDED|95.0|-6.22|10.63||See primary aims.|Mixed Models Analysis|||See primary aims.||10.63|-6.22|0.607
71767661|NCT02880956|143037248|SUPERIORITY||Least Squares (LS) Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.178||0.74|TWO_SIDED|95.0|-0.291|0.409||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.291|0.740
71715491|NCT02415556|142946351|OTHER|See primary aims.|Mean Difference (Final Values)|-2.1||||0.576|TWO_SIDED|95.0|-9.5|5.29||See primary aims.|Mixed Models Analysis|||See primary aims.||5.29|-9.50|0.576
71715492|NCT02415556|142946351|OTHER|See primary aims.|Mean Difference (Final Values)|-0.86||||0.802|TWO_SIDED|95.0|-7.58|5.87||See primary aims.|Mixed Models Analysis|||See primary aims.||5.87|-7.58|0.802
71715493|NCT02415556|142946352|EQUIVALENCE|CBF and vasoreactivity maps were analyzed on a voxel-by-voxel basis using Statistical non-Parametric Mapping (SnPM, http://www.sph.umich.edu/ni-stat/SnPM/), voxel-level threshold p \< 0.005.||||||0.03|||||||Voxel-Based Morphometry|||||||0.03
71767662|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71887002|NCT03434379|143294349|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.0001|TWO_SIDED|95.0|1.68|5.01|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.01|1.68|<0.0001
71887003|NCT03434379|143294350|SUPERIORITY||Odds Ratio (OR)|3.39|||<|0.0001|TWO_SIDED|95.0|2.02|5.71|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.71|2.02|<0.0001
71715494|NCT01621178|142946355|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.26|0.15|||Mixed Models Analysis|||Week 26||0.15|-0.26|<0.001
71715495|NCT01621178|142946355|NON_INFERIORITY|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.18|0.22|||Mixed Models Analysis|||Week 26||0.22|-0.18|<0.001
71715496|NCT02896257|142946393|SUPERIORITY||Odds Ratio (OR)|3.66|||<|0.001|TWO_SIDED|95.0|2.5|5.38|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||5.38|2.50|<0.001
71715497|NCT02896257|142946394|SUPERIORITY||Odds Ratio (OR)|0.8||||0.47|TWO_SIDED|95.0|0.44|1.47|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.47|0.44|0.47
71715498|NCT02896257|142946395|SUPERIORITY||Odds Ratio (OR)|0.63||||0.42|TWO_SIDED|95.0|0.2|1.96|||Regression, Logistic|Mixed-random effects for provider clustering and adjusting for smoking status. Multiple imputation by chained equations for missing smoking status.||||1.96|0.20|0.42
71715499|NCT02465931|142946401|OTHER|||||||0.89|||||||t-test, 1 sided|||||||0.89
71715500|NCT00492557|142946402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% confidence interval (CI), computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|1.7|||||TWO_SIDED|95.0|-3.1|6.5||||||Influenza virus subtype: A/H1N1. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||6.5|-3.1|
71887004|NCT03434379|143294351|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.99|12.66|||Cochran-Mantel-Haenszel|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.66|2.99|<0.0001
71715501|NCT00492557|142946402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-4.6|||||TWO_SIDED|95.0|-10.4|1.3||||||Influenza virus subtype: A/H3N2. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||1.3|-10.4|
71715502|NCT00492557|142946402|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV - TIV alone) was greater than -0.10.|Percent Difference|-1.8|||||TWO_SIDED|95.0|-7.8|4.1||||||Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) \<= -0.10.||4.1|-7.8|
71715503|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.6|1.04|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.04|0.60|
71715504|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.78|1.13|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.13|0.78|
71715505|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.66|||||TWO_SIDED|95.0|0.51|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.51|
71715506|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.55|0.86|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.86|0.55|
71887005|NCT03434379|143294352|SUPERIORITY||Hazard Ratio (HR)|0.23||||0.0051|TWO_SIDED|95.0|0.08|0.7|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.70|0.08|0.0051
71887006|NCT03434379|143294353|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.0048|TWO_SIDED|95.0|0.12|0.73|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.12|0.0048
71887007|NCT03434379|143294354|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.4187|TWO_SIDED|95.0|0.16|2.15|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||2.15|0.16|0.4187
71715507|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.76|||||TWO_SIDED|95.0|0.61|0.94|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.94|0.61|
71715508|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.75|1.25|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.25|0.75|
71715509|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.07|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.07|0.67|
71715510|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.02|0.63|
71715511|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.72|||||TWO_SIDED|95.0|0.53|0.97|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.97|0.53|
71715512|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.64|1.01|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.01|0.64|
71715513|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.7|||||TWO_SIDED|95.0|0.56|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.87|0.56|
71715514|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.85|0.49|
71715515|NCT00492557|142946403|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.71|1.27|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.71|
71715516|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.68|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.68|
71715517|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.69|1.2|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.20|0.69|
71715518|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|0.95|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||0.95|0.47|
71715519|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.77|1.6|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.60|0.77|
71715520|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.08|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.08|0.54|
71715521|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.55|1.09|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.09|0.55|
71715522|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.47|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.47|
71715523|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.42|1.03|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.03|0.42|
71715524|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.65|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.24|0.65|
71715525|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.59|1.14|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.14|0.59|
71715526|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.12|0.61|
71715527|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.16|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.16|0.57|
71887008|NCT03434379|143294355|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.46|<.0001
71656754|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||TWO_SIDED|95.0|-0.23|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.01|-0.23|
71828396|NCT01212757|143161362|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.7||||0.0002|TWO_SIDED|95.0|9.1|28.2|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.2|9.1|0.0002
71828397|NCT01212757|143161363|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14||||0.0042|TWO_SIDED|95.0|-0.236|-0.045|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.045|-0.236|0.0042
71828398|NCT01212757|143161363|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.104||||0.032|TWO_SIDED|95.0|-0.199|-0.009|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.009|-0.199|0.0320
71828399|NCT01212757|143161364|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.2||||0.0394|TWO_SIDED|95.0|0.5|17.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|0.5|0.0394
71828400|NCT01212757|143161364|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|15.7||||0.0009|TWO_SIDED|95.0|6.7|24.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.7|6.7|0.0009
71828401|NCT01212757|143161365|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.121||||0.0191|TWO_SIDED|95.0|-0.222|-0.02|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.020|-0.222|0.0191
71828402|NCT01212757|143161365|SUPERIORITY||LS Mean Difference|-0.08||||0.1179|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.020|-0.180|0.1179
71887009|NCT03434379|143294356|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.36|<.0001
71887010|NCT03434379|143294357|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0105|TWO_SIDED|95.0|0.53|0.92|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.92|0.53|0.0105
71656755|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.16|||||TWO_SIDED|95.0|-0.28|-0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||-0.04|-0.28|
71656756|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.17|
71715528|NCT00492557|142946406|NON_INFERIORITY_OR_EQUIVALENCE|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.27|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) \<= -0.693.||1.27|0.54|
71715529|NCT01493089|142946413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.563||95.0|||||Regression, Cox|||||||0.563
71767663|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.176||0.367|TWO_SIDED|95.0|-0.504|0.187||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.187|-0.504|0.367
71767664|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767665|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.843|TWO_SIDED|95.0|-0.318|0.389||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.389|-0.318|0.843
71767666|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767667|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.222||0.703|TWO_SIDED|95.0|-0.351|0.52||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.520|-0.351|0.703
71887011|NCT03434379|143294358|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0063|TWO_SIDED|95.0|0.52|0.9|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.90|0.52|0.0063
71715530|NCT01493089|142946414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.903||||0.712||95.0|||||Regression, Cox|||||||0.712
71715531|NCT01493089|142946415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.457|TWO_SIDED|95.0|||||Regression, Cox|||||||0.457
71767668|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71715532|NCT01493089|142946416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.625||95.0|-9.7|15.3|||Regression, Cox|||Sustained partial response||15.3|-9.7|0.625
71715533|NCT01493089|142946416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.755|TWO_SIDED|95.0|-15.0|10.6|||Regression, Cox|||Sustained response||10.6|-15.0|0.755
71715534|NCT01493089|142946416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8||||0.194|TWO_SIDED|95.0|-3.6|17.2|||Regression, Cox|||Sustained total relief||17.2|-3.6|0.194
71715535|NCT01493089|142946417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.501|TWO_SIDED|95.0|-15.0|7.0|||Regression, Cox|||Sustained partial response||7.0|-15.0|0.501
71715536|NCT01493089|142946417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.518|TWO_SIDED|95.0|-17.6|8.2|||Regression, Cox|||Sustained response||8.2|-17.6|0.518
71715537|NCT01493089|142946417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.794|TWO_SIDED|95.0|-11.2|13.1|||Regression, Cox|||Sustained total relief||13.1|-11.2|0.794
71767669|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.218||0.947|TWO_SIDED|95.0|-0.442|0.413||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.413|-0.442|0.947
71767670|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71887012|NCT03434379|143294359|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.57|||Log Rank|||Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.57|0.35|<.0001
71715538|NCT01493089|142946418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.494|TWO_SIDED|95.0|-6.3|11.2|||Regression, Cox|||Sustained partial response||11.2|-6.3|0.494
71715539|NCT01493089|142946418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.751|TWO_SIDED|95.0|-14.7|9.1|||Regression, Cox|||Sustained response||9.1|-14.7|0.751
71715540|NCT01493089|142946418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.69|TWO_SIDED|95.0|-16.4|9.6|||Regression, Cox|||Sustained total relief||9.6|-16.4|0.690
71715541|NCT01008618|142946436|SUPERIORITY_OR_OTHER|||||||0.0846|||||||Log Rank|||||||0.0846
71715542|NCT00565409|142946494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.2|9.0||P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region.|Cochran-Mantel-Haenszel|Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis.||Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified.||9.0|3.2|<0.0001
71767671|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.222||0.732|TWO_SIDED|95.0|-0.514|0.361||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.361|-0.514|0.732
71767672|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767673|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.939|TWO_SIDED|95.0|-0.623|0.576||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.576|-0.623|0.939
71767674|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767675|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.299||0.872|TWO_SIDED|95.0|-0.637|0.54||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.540|-0.637|0.872
71767676|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767677|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.305||0.773|TWO_SIDED|95.0|-0.688|0.512||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.512|-0.688|0.773
71767678|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767679|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.387||0.848|TWO_SIDED|95.0|-0.834|0.686||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.686|-0.834|0.848
71767680|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767681|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.38||0.869|TWO_SIDED|95.0|-0.81|0.684||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.684|-0.810|0.869
71767682|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767683|NCT02880956|143037248|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.389||0.679|TWO_SIDED|95.0|-0.603|0.925||The statistical model: CDR change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.603|0.679
71767684|NCT02880956|143037248|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|2.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767685|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.693||0.562|TWO_SIDED|95.0|-1.764|0.96||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.960|-1.764|0.562
71767686|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767687|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.682||0.066|TWO_SIDED|95.0|-2.602|0.081||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.081|-2.602|0.066
71767688|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|5.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767689|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.7||0.962|TWO_SIDED|95.0|-1.343|1.41||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.410|-1.343|0.962
71767690|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|5.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71715543|NCT00565409|142946494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.3805|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||2.0|0.7|0.3805
71828403|NCT01212757|143161366|SUPERIORITY||LS Mean Difference|2.1||||0.0237|TWO_SIDED|95.0|0.28|3.92|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.92|0.28|0.0237
71828404|NCT01212757|143161366|SUPERIORITY||LS Mean Difference|1.36||||0.1388|TWO_SIDED|95.0|-0.44|3.15|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above||3.15|-0.44|0.1388
71828405|NCT01212757|143161367|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9||||0.0065|TWO_SIDED|95.0|4.3|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.5|4.3|0.0065
71828406|NCT01212757|143161367|SUPERIORITY||Adjusted Difference|14.7||||0.0071|TWO_SIDED|95.0|4.1|25.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||25.2|4.1|0.0071
71828407|NCT01212757|143161368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9||||0.0648|TWO_SIDED|95.0|-10.0|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-10.0|0.0648
71828408|NCT01212757|143161368|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.5||||0.0347|TWO_SIDED|95.0|-10.6|-0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.4|-10.6|0.0347
71828409|NCT01212757|143161369|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.3496|TWO_SIDED|95.0|-1.2|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.2|0.3496
71828410|NCT01212757|143161369|SUPERIORITY||LS Mean Difference|0.1||||0.8874|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.7|0.8874
71828411|NCT01212757|143161370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.5438|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.5|-1.0|0.5438
71828412|NCT01212757|143161370|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.3759|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.0|-0.4|0.3759
71828413|NCT01212757|143161371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51||||0.0035|TWO_SIDED|95.0|-5.86|-1.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-1.16|-5.86|0.0035
71828414|NCT01212757|143161371|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.45||||0.0002|TWO_SIDED|95.0|-6.76|-2.14|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.14|-6.76|0.0002
71828415|NCT01212757|143161372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.0004|TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.18|-0.61|0.0004
71828416|NCT01212757|143161372|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.25|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.25|-0.68|<0.0001
71828417|NCT01212757|143161373|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12||||0.0318|TWO_SIDED|95.0|0.19|4.06|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.06|0.19|0.0318
71828418|NCT01212757|143161373|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.27||||0.7803|TWO_SIDED|95.0|-1.65|2.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.20|-1.65|0.7803
71828419|NCT01212757|143161374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86||||0.0473|TWO_SIDED|95.0|0.02|3.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.70|0.02|0.0473
71828420|NCT01212757|143161374|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.53||||0.0997|TWO_SIDED|95.0|-0.29|3.35|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.35|-0.29|0.0997
71715544|NCT00565409|142946494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.||||7.6|3.0|<0.0001
71715545|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11||||0.0853|TWO_SIDED|95.0|0.5|21.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||21.4|0.5|0.0853
71887013|NCT03434379|143294360|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.78|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.78|0.32|0.0019
71715546|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8491|TWO_SIDED|95.0|0.2|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||4.8|0.2|0.8491
71715547|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97||||0.1278|TWO_SIDED|95.0|0.4|42.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity||42.5|0.4|0.1278
71715548|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||6.4|2.1|<0.0001
71715549|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.3027|TWO_SIDED|95.0|0.8|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||2.7|0.8|0.3027
71715550|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.0001|TWO_SIDED|95.0|1.5|4.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity||4.2|1.5|<0.0001
71715551|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55|||<|0.0001|TWO_SIDED|95.0|2.7|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||7.6|2.7|<0.0001
71715552|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5871|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||2.1|0.7|0.5871
71715553|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.3|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity||6.1|2.3|<0.0001
71715554|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.52|||<|0.0001|TWO_SIDED|95.0|3.9|11.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||11.0|3.9|<0.0001
71715555|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6716|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||2.0|0.6|0.6716
71715556|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.4|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity||8.6|3.4|<0.0001
71715557|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.0001|TWO_SIDED|95.0|2.8|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.6|2.8|<0.0001
71715558|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.9399|TWO_SIDED|95.0|0.5|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||1.5|0.5|0.9399
71715559|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|95.0|3.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity||7.7|3.0|<0.0001
71715560|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.25|||<|0.0001|TWO_SIDED|95.0|3.7|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||10.5|3.7|<0.0001
71767691|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.887||0.265|TWO_SIDED|95.0|-2.734|0.755||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.755|-2.734|0.265
71887014|NCT03434379|143294360|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0879|TWO_SIDED|95.0|0.42|1.06|||Log Rank|||AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.06|0.42|0.0879
71715561|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.6692|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||1.9|0.6|0.6692
71715562|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||<|0.0001|TWO_SIDED|95.0|3.4|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity||8.7|3.4|<0.0001
71715563|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.4|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||9.8|3.4|<0.0001
71715564|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4326|TWO_SIDED|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||2.1|0.7|0.4326
71767692|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767693|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.863||0.212|TWO_SIDED|95.0|-2.775|0.618||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.618|-2.775|0.212
71767694|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.29|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767695|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.893||0.602|TWO_SIDED|95.0|-2.223|1.29||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.290|-2.223|0.602
71715565|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12|||<|0.0001|TWO_SIDED|95.0|3.2|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity||8.2|3.2|<0.0001
71715566|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.8|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.8|2.8|<0.0001
71715567|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.6064|TWO_SIDED|95.0|0.6|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||1.8|0.6|0.6064
71715568|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|3.0|7.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity||7.4|3.0|<0.0001
71715569|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.4626|TWO_SIDED|95.0|0.5|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.5|0.4626
71715570|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.2886|TWO_SIDED|95.0|0.6|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||3.3|0.6|0.2886
71887015|NCT03434379|143294361|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.37|0.68|||Log Rank|||AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.68|0.37|<.0001
71715571|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.7779|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission||1.9|0.4|0.7779
71715572|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.94|||<|0.0001|TWO_SIDED|95.0|1.8|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||4.7|1.8|<0.0001
71715573|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2091|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||2.0|0.8|0.2091
71767696|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|6.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71887016|NCT03434379|143294361|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.2159|TWO_SIDED|95.0|0.53|1.15|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||1.15|0.53|0.2159
71715574|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31|||<|0.0001|TWO_SIDED|95.0|1.5|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission||3.6|1.5|<0.0001
71715575|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.1|5.2||p-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||5.2|2.1|<0.0001
71715576|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5351|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||1.7|0.7|0.5351
71715577|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.0001|TWO_SIDED|95.0|2.0|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission||4.8|2.0|<0.0001
71715578|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.0001|TWO_SIDED|95.0|2.6|6.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||6.5|2.6|<0.0001
71715579|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.4574|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||1.3|0.5|0.4574
71715580|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.2|8.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission||8.0|3.2|<0.0001
71767697|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.019||0.635|TWO_SIDED|95.0|-2.489|1.519||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.519|-2.489|0.635
71715581|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.6|2.7|<0.0001
71715582|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5229|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||1.8|0.7|0.5229
71715583|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission||6.0|2.5|<0.0001
71715584|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|3.3|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||8.6|3.3|<0.0001
71715585|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6464|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||1.8|0.7|0.6464
71715586|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.79|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission||7.6|3.0|<0.0001
71715587|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96|||<|0.0001|TWO_SIDED|95.0|3.1|7.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||7.9|3.1|<0.0001
71767698|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|6.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71715588|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.5499|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission||1.7|0.7|0.5499
71715589|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.0001|TWO_SIDED|95.0|2.6|6.4|||Cochran-Mantel-Haenszel|||Week 80 Remission||6.4|2.6|<0.0001
71715590|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.8|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||7.0|2.8|<0.0001
71715591|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.1109|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||1.9|0.8|0.1109
71715592|NCT00565409|142946496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001|TWO_SIDED|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission||6.0|2.5|<0.0001
71715593|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
71715594|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9344|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||0.2|-0.2|0.9344
71715595|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40||-0.4|-0.7|<0.0001
71715596|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.0|<0.0001
71887017|NCT03434379|143294362|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.31|0.57|||Log Rank|||AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.57|0.31|<0.0001
71715597|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6173|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||0.2|-0.1|0.6173
71715598|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48||-0.7|-1.1|<0.0001
71715599|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.7|-1.1|<0.0001
71715600|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.5136|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||0.3|-0.1|0.5136
71715601|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56||-0.8|-1.2|<0.0001
71715602|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
71715603|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.4868|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||0.3|-0.1|0.4868
71715604|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64||-0.7|-1.1|<0.0001
71715605|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.3|<0.0001
71715606|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7847|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||0.2|-0.2|0.7847
71715607|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72||-0.8|-1.2|<0.0001
71715608|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
71715609|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.981|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||0.2|-0.2|0.9810
71715610|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80||-0.8|-1.2|<0.0001
71767699|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.003||0.795|TWO_SIDED|95.0|-2.233|1.712||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.712|-2.233|0.795
71767700|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71828421|NCT01212757|143161375|SUPERIORITY||Adjusted Difference|7.8||||0.1195|TWO_SIDED|95.0|-1.9|17.5||The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.5|-1.9|0.1195
71828422|NCT01212757|143161375|SUPERIORITY||Adjusted Difference|15.5||||0.0026|TWO_SIDED|95.0|5.6|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.5|5.6|0.0026
71828423|NCT01212757|143161376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.7||||0.5067|TWO_SIDED|95.0|-6.8|3.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.4|-6.8|0.5067
71715611|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.8|-1.3|<0.0001
71715612|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3562|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||0.1|-0.3|0.3562
71715613|NCT00565409|142946498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88||-0.7|-1.2|<0.0001
71715614|NCT00565409|142946499|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
71715615|NCT00565409|142946499|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||<0.0001
71715616|NCT00565409|142946499|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.||||0.8622
71715617|NCT00565409|142946500|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
71715618|NCT00565409|142946500|SUPERIORITY_OR_OTHER|||||||0.9841|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||0.9841
71715619|NCT00565409|142946500|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Week 88 censored data was censored at 372 days.|Log Rank|||||||<0.0001
71715620|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
71715621|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8015|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.3|0.8015
71715622|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
71715623|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.7|-1.5|<0.0001
71715624|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.8534|TWO_SIDED|95.0|-0.4|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.4|0.8534
71767701|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|1.11|STANDARD_ERROR_OF_MEAN|1.027||0.281|TWO_SIDED|95.0|-0.91|3.128||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.128|-0.910|0.281
71715625|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.6|<0.0001
71715626|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
71715627|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9074|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.4|0.9074
71715628|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.7|<0.0001
71715629|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
71715630|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9229|TWO_SIDED|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.4|0.9229
71715631|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.8|<0.0001
71715632|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
71715633|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9279|TWO_SIDED|95.0|-0.5|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.5|0.9279
71715634|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.9|<0.0001
71715635|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.1|-2.1|<0.0001
71715636|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7695|TWO_SIDED|95.0|-0.6|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.4|-0.6|0.7695
71715637|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-2.0|<0.0001
71715638|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-2.3|<0.0001
71715639|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.2182|TWO_SIDED|95.0|-0.8|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.8|0.2182
71715640|NCT00565409|142946504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.9|<0.0001
71715641|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0003|TWO_SIDED|95.0|-1.3|-0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.4|-1.3|0.0003
71715642|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.6088|TWO_SIDED|95.0|-0.3|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.6|-0.3|0.6088
71715643|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.4|<0.0001
71715644|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.4|-2.6|<0.0001
71715645|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.9048|TWO_SIDED|95.0|-0.5|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANOVA|||Week 48||0.6|-0.5|0.9048
71715646|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.5|-2.6|<0.0001
71715647|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.5|-2.6|<0.0001
71715648|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8437|TWO_SIDED|95.0|-0.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.5|-0.6|0.8437
71715649|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-1.4|-2.6|<0.0001
71715650|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
71715651|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8587|TWO_SIDED|95.0|-0.6|0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.7|-0.6|0.8587
71715652|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.4|-2.6|<0.0001
71715653|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.8|-3.0|<0.0001
71715654|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6323|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.5|-0.8|0.6323
71715655|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.6|-2.9|<0.0001
71715656|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.6|-2.9|<0.0001
71715657|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.6558|TWO_SIDED|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.5|-0.8|0.6558
71715658|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.5|-2.8|<0.0001
71715659|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.1|<0.0001
71715660|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8688|TWO_SIDED|95.0|-0.7|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.6|-0.7|0.8688
71715661|NCT00565409|142946507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.7|-3.0|<0.0001
71715662|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
71715663|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9636|TWO_SIDED|95.0|-0.2|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.2|0.9636
71715664|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.0|<0.0001
71715665|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.8|-1.4|<0.0001
71715666|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.4605|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.4|-0.2|0.4605
71715667|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.5|<0.0001
71715668|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.4|<0.0001
71715669|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8404|TWO_SIDED|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.3|-0.3|0.8404
71767702|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767703|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261||0.729|TWO_SIDED|95.0|-2.918|2.043||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.043|-2.918|0.729
71887018|NCT03434379|143294362|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.35|0.73|||Log Rank|||AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).||0.73|0.35|0.0002
71715670|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.4|<0.0001
71887019|NCT03434379|143294363|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.73|||Log Rank|||Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.73|0.39|<.0001
71887020|NCT03434379|143294363|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0019|TWO_SIDED|95.0|0.46|0.84|||Log Rank|||Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.84|0.46|0.0019
71715671|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.4|<0.0001
71715672|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.3118|TWO_SIDED|95.0|-0.1|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.5|-0.1|0.3118
71715673|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-1.0|-1.6|<0.0001
71715674|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
71715675|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.61|TWO_SIDED|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.4|-0.2|0.6100
71715676|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.0|-1.6|<0.0001
71715677|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
71715678|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.6552|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||0.2|-0.4|0.6552
71715679|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.0|-1.6|<0.0001
71887021|NCT03434379|143294363|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0028|TWO_SIDED|95.0|0.46|0.85|||Log Rank|||GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.85|0.46|0.0028
71887022|NCT03434379|143294368|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0036|TWO_SIDED|95.0|1.53|13.86|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||13.86|1.53|0.0036
71887023|NCT03434379|143294369|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0013|TWO_SIDED|95.0|1.72|12.87|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||12.87|1.72|0.0013
71887024|NCT03434379|143294370|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0052|TWO_SIDED|95.0|1.47|17.39|||Cochran-Mantel-Haenszel|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||17.39|1.47|0.0052
71656757|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
71656758|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.18|||||TWO_SIDED|95.0|-0.28|-0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.07|-0.28|
71656759|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.02|-0.19|
71656760|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.25|||||TWO_SIDED|95.0|0.13|0.37|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.37|0.13|
71656761|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||TWO_SIDED|95.0|-0.12|0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.12|-0.12|
71656762|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.25|||||TWO_SIDED|95.0|-0.37|-0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||-0.13|-0.37|
71656763|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.14|||||TWO_SIDED|95.0|0.02|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.25|0.02|
71656764|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.01|0.24|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.24|0.01|
71656765|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||TWO_SIDED|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.11|-0.13|
71656766|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.09|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.10|-0.09|
71656767|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.14|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.14|
71715680|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.1|-1.8|<0.0001
71715681|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4753|TWO_SIDED|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.2|-0.4|0.4753
71715682|NCT00565409|142946510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.0|-1.6|<0.0001
71715683|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.6|-1.2|<0.0001
71715684|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.7427|TWO_SIDED|95.0|-0.4|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.3|-0.4|0.7427
71715685|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-0.5|-1.1|<0.0001
71715686|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-1.1|-1.7|<0.0001
71715687|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3129|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||0.2|-0.5|0.3129
71715688|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-0.9|-1.6|<0.0001
71715689|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.9|-1.6|<0.0001
71715690|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.4645|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||0.2|-0.5|0.4645
71715691|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-0.8|-1.5|<0.0001
71715692|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.9|-1.7|<0.0001
71715693|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.3793|TWO_SIDED|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||0.2|-0.5|0.3793
71715694|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-0.8|-1.5|<0.0001
71715695|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-1.2|-2.0|<0.0001
71715696|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0816|TWO_SIDED|95.0|-0.7|0.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.0|-0.7|0.0816
71715697|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-0.9|-1.6|<0.0001
71715698|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-1.2|-1.9|<0.0001
71715699|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0256|TWO_SIDED|95.0|-0.8|-0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.1|-0.8|0.0256
71715700|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-0.8|-1.5|<0.0001
71887025|NCT03434379|143294371|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.4581|TWO_SIDED|95.0|0.02|5.85|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||5.85|0.02|0.4581
71715701|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-1.2|-1.9|<0.0001
71715702|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.1158|TWO_SIDED|95.0|-0.7|0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||0.1|-0.7|0.1158
71715703|NCT00565409|142946513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-0.9|-1.6|<0.0001
71715704|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67||||0.0214|TWO_SIDED|95.0|-77.1|-6.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-6.2|-77.1|0.0214
71715705|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.57||||0.5544|TWO_SIDED|95.0|-45.6|24.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||24.5|-45.6|0.5544
71715706|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1||||0.0826|TWO_SIDED|95.0|-66.2|4.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||4.0|-66.2|0.0826
71767704|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|7.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767705|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|1.248||0.636|TWO_SIDED|95.0|-3.047|1.863||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.863|-3.047|0.636
71828424|NCT01212757|143161376|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-3.5||||0.1762|TWO_SIDED|95.0|-8.5|1.6|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||1.6|-8.5|0.1762
71828425|NCT01212757|143161377|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.2719|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.3|-1.2|0.2719
71828426|NCT01212757|143161377|SUPERIORITY||LS Mean Difference|0.0||||0.9727|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.7|-0.8|0.9727
71715707|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-80.05||||0.0001|TWO_SIDED|95.0|-120.3|-39.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-39.8|-120.3|0.0001
71715708|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.18||||0.0344|TWO_SIDED|95.0|-83.2|-3.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-3.2|-83.2|0.0344
71715709|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.87||||0.0721|TWO_SIDED|95.0|-77.1|3.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.3|-77.1|0.0721
71715710|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.19|||<|0.0001|TWO_SIDED|95.0|-128.7|-49.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-49.7|-128.7|<0.0001
71767706|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|7.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828427|NCT01212757|143161378|SUPERIORITY||LS Mean Difference|-0.3||||0.3705|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.4|-1.0|0.3705
71828428|NCT01212757|143161378|SUPERIORITY||LS Mean Difference|0.1||||0.6777|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||0.8|-0.6|0.6777
71715711|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.14||||0.191|TWO_SIDED|95.0|-65.4|13.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||13.1|-65.4|0.1910
71715712|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.05||||0.0018|TWO_SIDED|95.0|-102.5|-23.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-23.6|-102.5|0.0018
71715713|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-84.36||||0.0002|TWO_SIDED|95.0|-129.1|-39.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-39.6|-129.1|0.0002
71715714|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.935|TWO_SIDED|95.0|-46.3|42.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||42.6|-46.3|0.9350
71715715|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-82.52||||0.0003|TWO_SIDED|95.0|-127.2|-37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-37.8|-127.2|0.0003
71715716|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.73|||<|0.0001|TWO_SIDED|95.0|-157.0|-60.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-60.4|-157.0|<0.0001
71715717|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.6764|TWO_SIDED|95.0|-58.2|37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||37.8|-58.2|0.6764
71715718|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-98.53|||<|0.0001|TWO_SIDED|95.0|-146.7|-50.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-50.3|-146.7|<0.0001
71715719|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-115.48|||<|0.0001|TWO_SIDED|95.0|-157.7|-73.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-73.3|-157.7|<0.0001
71767707|NCT02880956|143037257|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|1.294||0.427|TWO_SIDED|95.0|-1.515|3.575||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.575|-1.515|0.427
71767708|NCT02880956|143037257|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|7.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767709|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.69|TWO_SIDED|95.0|-0.083|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.083|0.690
71828429|NCT01212757|143161379|SUPERIORITY||LS Mean Difference|-3.14||||0.0097|TWO_SIDED|95.0|-5.52|-0.76|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.76|-5.52|0.0097
71715720|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69||||0.5219|TWO_SIDED|95.0|-55.6|28.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||28.3|-55.6|0.5219
71715721|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.8|||<|0.0001|TWO_SIDED|95.0|-144.0|-59.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-59.6|-144.0|<0.0001
71715722|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-71.6||||0.002|TWO_SIDED|95.0|-116.9|-26.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-26.3|-116.9|0.0020
71715723|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3||||0.5917|TWO_SIDED|95.0|-32.7|57.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||57.3|-32.7|0.5917
71715724|NCT00565409|142946516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.91||||0.0003|TWO_SIDED|95.0|-129.2|-38.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-38.7|-129.2|0.0003
71715725|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.79|||<|0.0001|TWO_SIDED|95.0|-11.9|-5.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.7|-11.9|<0.0001
71767710|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|0.39|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828430|NCT01212757|143161379|SUPERIORITY||LS Mean Difference|-4.5||||0.0002|TWO_SIDED|95.0|-6.85|-2.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.16|-6.85|0.0002
71715726|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55||||0.1033|TWO_SIDED|95.0|-5.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||0.5|-5.6|0.1033
71715727|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|||<|0.0001|TWO_SIDED|95.0|-9.3|-3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-3.1|-9.3|<0.0001
71715728|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.8|-15.4|<0.0001
71715729|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.6802|TWO_SIDED|95.0|-4.0|2.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||2.6|-4.0|0.6802
71715730|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.39|||<|0.0001|TWO_SIDED|95.0|-14.7|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-8.1|-14.7|<0.0001
71767711|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.052||0.595|TWO_SIDED|95.0|-0.075|0.131||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.131|-0.075|0.595
71715731|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.6|-15.6|<0.0001
71715732|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.4404|TWO_SIDED|95.0|-4.8|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||2.1|-4.8|0.4404
71715733|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||<|0.0001|TWO_SIDED|95.0|-14.2|-7.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.2|-14.2|<0.0001
71715734|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.83|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-9.4|-16.2|<0.0001
71715735|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4437|TWO_SIDED|95.0|-4.7|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||2.1|-4.7|0.4437
71767712|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828431|NCT01212757|143161380|SUPERIORITY||LS Mean Difference|-0.38||||0.0011|TWO_SIDED|95.0|-0.6|-0.15|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.15|-0.60|0.0011
71828432|NCT01212757|143161380|SUPERIORITY||LS Mean Difference|-0.45||||0.0001|TWO_SIDED|95.0|-0.68|-0.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.23|-0.68|0.0001
71715736|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.51|||<|0.0001|TWO_SIDED|95.0|-14.9|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.1|-14.9|<0.0001
71715737|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.79|||<|0.0001|TWO_SIDED|95.0|-18.5|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.1|-18.5|<0.0001
71715738|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.096|TWO_SIDED|95.0|-6.8|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||0.6|-6.8|0.0960
71715739|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.67|||<|0.0001|TWO_SIDED|95.0|-15.4|-8.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-8.0|-15.4|<0.0001
71715740|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.56|||<|0.0001|TWO_SIDED|95.0|-18.1|-11.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.0|-18.1|<0.0001
71715741|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.2948|TWO_SIDED|95.0|-5.4|1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.6|-5.4|0.2948
71767713|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.054||0.201|TWO_SIDED|95.0|0.037|0.175||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.175|0.037|0.201
71767714|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71715742|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.0001|TWO_SIDED|95.0|-16.2|-9.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-9.1|-16.2|<0.0001
71715743|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.0001|TWO_SIDED|95.0|-16.9|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-9.5|-16.9|<0.0001
71715744|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.213|TWO_SIDED|95.0|-6.0|1.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.3|-6.0|0.2130
71715745|NCT00565409|142946519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.83|||<|0.0001|TWO_SIDED|95.0|-14.5|-7.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-7.1|-14.5|<0.0001
71828433|NCT01212757|143161381|SUPERIORITY||LS Mean Difference|2.14||||0.0303|TWO_SIDED|95.0|0.2|4.07|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.07|0.20|0.0303
71715746|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||<|0.0001|TWO_SIDED|95.0|-11.8|-5.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-5.3|-11.8|<0.0001
71715747|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8033|TWO_SIDED|95.0|-3.6|2.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||2.8|-3.6|0.8033
71715748|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.14|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 40||-4.9|-11.3|<0.0001
71715749|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.61|||<|0.0001|TWO_SIDED|95.0|-17.2|-10.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-10.0|-17.2|<0.0001
71715750|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.783|TWO_SIDED|95.0|-4.1|3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||3.1|-4.1|0.7830
71767715|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.064||0.361|TWO_SIDED|95.0|-0.067|0.184||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.184|-0.067|0.361
71767716|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767717|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.062||0.522|TWO_SIDED|95.0|-0.082|0.162||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|Week 48||0.162|-0.082|0.522
71828434|NCT01212757|143161381|SUPERIORITY||LS mean Difference|0.16||||0.8704|TWO_SIDED|95.0|-1.76|2.08|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||2.08|-1.76|0.8704
71715751|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.11|||<|0.0001|TWO_SIDED|95.0|-16.7|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 48||-9.5|-16.7|<0.0001
71715752|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-8.9|-16.1|<0.0001
71715753|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.5732|TWO_SIDED|95.0|-4.6|2.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization|ANCOVA|||Week 56||2.5|-4.6|0.5732
71715754|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.1|-7.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 56||-7.9|-15.1|<0.0001
71715755|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88|||<|0.0001|TWO_SIDED|95.0|-17.6|-10.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-10.2|-17.6|<0.0001
71767718|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767719|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.064||0.147|TWO_SIDED|95.0|-0.033|0.219||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.219|-0.033|0.147
71828435|NCT01212757|143161382|SUPERIORITY||Adjusted Difference|3.6||||0.6022|TWO_SIDED|95.0|-9.9|17.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||17.2|-9.9|0.6022
71715756|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.2972|TWO_SIDED|95.0|-5.6|1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||1.7|-5.6|0.2972
71715757|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.94|||<|0.0001|TWO_SIDED|95.0|-15.6|-8.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 64||-8.3|-15.6|<0.0001
71715758|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.4|-11.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-11.8|-19.4|<0.0001
71715759|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1477|TWO_SIDED|95.0|-6.6|1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||1.0|-6.6|0.1477
71715760|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85|||<|0.0001|TWO_SIDED|95.0|-16.6|-9.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 72||-9.0|-16.6|<0.0001
71715761|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.87|||<|0.0001|TWO_SIDED|95.0|-18.6|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-11.1|-18.6|<0.0001
71715762|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.1808|TWO_SIDED|95.0|-6.3|1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||1.2|-6.3|0.1808
71715763|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 80||-8.5|-16.1|<0.0001
71715764|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||<|0.0001|TWO_SIDED|95.0|-18.5|-10.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-10.9|-18.5|<0.0001
71715765|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.2077|TWO_SIDED|95.0|-6.2|1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||1.4|-6.2|0.2077
71715766|NCT00565409|142946522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.26|||<|0.0001|TWO_SIDED|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (\<2.6) at randomization.|ANCOVA|||Week 88||-8.5|-16.1|<0.0001
71715767|NCT00565409|142946523|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
71715768|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8974|TWO_SIDED|95.0|0.5|2.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.5|0.5|0.8974
71715769|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1105|TWO_SIDED|95.0|0.8|3.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||3.7|0.8|0.1105
71715770|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.19|TWO_SIDED|95.0|0.3|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.3|0.1900
71715771|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.3|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.3|<0.0001
71715772|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.4032|TWO_SIDED|95.0|0.6|2.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.4|0.6|0.4032
71715773|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.4|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||7.5|2.4|<0.0001
71715774|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001|TWO_SIDED|95.0|2.1|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.1|<0.0001
71715775|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0272|TWO_SIDED|95.0|1.0|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||3.6|1.0|0.0272
71715776|NCT00565409|142946524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.4|4.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.0|1.4|0.0004
71715777|NCT00565409|142946525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71715778|NCT00565409|142946525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71715779|NCT00565409|142946525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71715780|NCT00565409|142946525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71715781|NCT00565409|142946525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71715782|NCT00565409|142946525|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71715783|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29||||0.1718|TWO_SIDED|95.0|0.5|10.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.7|0.5|0.1718
71715784|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.8303|TWO_SIDED|95.0|0.2|7.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||7.3|0.2|0.8303
71715785|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.213|TWO_SIDED|95.0|0.5|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||10.1|0.5|0.2130
71715786|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.1|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||8.2|2.1|<0.0001
71715787|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.4337|TWO_SIDED|95.0|0.3|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.0|0.3|0.4337
71715788|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.14|||<|0.0001|TWO_SIDED|95.0|2.5|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||10.8|2.5|<0.0001
71715789|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.0|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.5|3.0|<0.0001
71715790|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.8973|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.9|0.4|0.8973
71715791|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|2.8|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||10.1|2.8|<0.0001
71715792|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.4|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||8.1|2.4|<0.0001
71715793|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5708|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.4|0.5708
71715794|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.58|||<|0.0001|TWO_SIDED|95.0|3.0|10.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||10.3|3.0|<0.0001
71715795|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.29|||<|0.0001|TWO_SIDED|95.0|3.3|12.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||12.0|3.3|<0.0001
71715796|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8842|TWO_SIDED|95.0|0.4|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.4|0.8842
71715797|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.92|||<|0.0001|TWO_SIDED|95.0|3.2|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.8|3.2|<0.0001
71715798|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.0001|TWO_SIDED|95.0|3.8|14.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||14.4|3.8|<0.0001
71715799|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.1608|TWO_SIDED|95.0|0.6|3.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||3.1|0.6|0.1608
71715800|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.92|||<|0.0001|TWO_SIDED|95.0|2.9|8.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.4|2.9|<0.0001
71715801|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|3.4|12.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||12.4|3.4|<0.0001
71715802|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.2825|TWO_SIDED|95.0|0.6|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||2.7|0.6|0.2825
71715803|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.7|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|2.7|<0.0001
71715804|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.0001|TWO_SIDED|95.0|2.7|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.7|2.7|<0.0001
71715805|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.4471|TWO_SIDED|95.0|0.5|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.1|0.5|0.4471
71715806|NCT00565409|142946526|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.0|2.5|<0.0001
71715807|NCT00565409|142946527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71715808|NCT00565409|142946527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71715809|NCT00565409|142946527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71715810|NCT00565409|142946527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71715811|NCT00565409|142946527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71715812|NCT00565409|142946527|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71715813|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6006|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.4|0.6006
71715814|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.4967|TWO_SIDED|95.0|0.6|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.1|0.6|0.4967
71715815|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3648|TWO_SIDED|95.0|0.4|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.5|0.4|0.3648
71715816|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0024|TWO_SIDED|95.0|1.2|3.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.2|1.2|0.0024
71715817|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8308||95.0|0.6|||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.|0.6|0.8308
71715818|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.0008|TWO_SIDED|95.0|1.3|3.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.4|1.3|0.0008
71715819|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25|||<|0.0001|TWO_SIDED|95.0|2.0|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.2|2.0|<0.0001
71715820|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7374|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.8|0.7|0.7374
71715821|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.8|1.9|<0.0001
71715822|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.8|1.9|<0.0001
71887026|NCT03434379|143294372|SUPERIORITY||Hazard Ratio (HR)|0.08||||0.01|TWO_SIDED|95.0|0.01|0.91|||Log Rank||Lower limit: \<0.01|Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.91|0.01|0.0100
71715823|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9599|TWO_SIDED|95.0|0.6|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.7|0.6|0.9599
71715824|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.6|1.9|<0.0001
71715825|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.3|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.7|2.3|<0.0001
71715826|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4509|TWO_SIDED|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||2.0|0.8|0.4509
71715827|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.6|1.9|<0.0001
71715828|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.6|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.0|2.6|<0.0001
71715829|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.3037|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.0|0.7|0.3037
71767720|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71715830|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.0001|TWO_SIDED|95.0|2.1|5.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.1|2.1|<0.0001
71715831|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.7|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.2|2.7|<0.0001
71715832|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.6076|TWO_SIDED|95.0|0.7|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.7|0.6076
71715833|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.0|2.4|<0.0001
71715834|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.6|1.8|<0.0001
71715835|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.7837|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.6|0.6|0.7837
71715836|NCT00565409|142946528|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||4.7|2.0|<0.0001
71715837|NCT00565409|142946529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71767721|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.492|TWO_SIDED|95.0|-0.243|0.117||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.117|-0.243|0.492
71887027|NCT03434379|143294373|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.3477|TWO_SIDED|95.0|0.03|3.69|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||3.69|0.03|0.3477
71715838|NCT00565409|142946529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71715839|NCT00565409|142946529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71715840|NCT00565409|142946529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71715841|NCT00565409|142946529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71715842|NCT00565409|142946529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71715843|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.5263|TWO_SIDED|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.0|0.7|0.5263
71715844|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1055|TWO_SIDED|95.0|0.9|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|0.9|0.1055
71715845|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4348|TWO_SIDED|95.0|0.5|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.4|0.5|0.4348
71715846|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0003|TWO_SIDED|95.0|1.4|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.3|1.4|0.0003
71715847|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5511|TWO_SIDED|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.7|0.7|0.5511
71715848|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0013|TWO_SIDED|95.0|1.3|2.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||2.9|1.3|0.0013
71715849|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.8|4.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.3|1.8|<0.0001
71767722|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767723|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.691|TWO_SIDED|95.0|-0.213|0.141||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.141|-0.213|0.691
71715850|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9225|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.5|0.6|0.9225
71715851|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.0001|TWO_SIDED|95.0|1.9|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||4.5|1.9|<0.0001
71715852|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.2|||<|0.0001|TWO_SIDED|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.6|2.7|<0.0001
71715853|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.2454|TWO_SIDED|95.0|0.9|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.9|0.2454
71715854|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||4.9|2.0|<0.0001
71715855|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.0|2.4|<0.0001
71715856|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4919|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.9|0.8|0.4919
71715857|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||4.9|2.0|<0.0001
71715858|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||7.6|3.0|<0.0001
71715859|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0658|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||2.3|1.0|0.0658
71767724|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71887028|NCT03434379|143294374|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0103|TWO_SIDED|95.0|0.4|0.89|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.89|0.40|0.0103
71887029|NCT03434379|143294375|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0002|TWO_SIDED|95.0|0.33|0.71|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.71|0.33|0.0002
71887030|NCT03434379|143294376|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0927|TWO_SIDED|95.0|0.43|1.07|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.07|0.43|0.0927
71887031|NCT03434379|143294377|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0861|TWO_SIDED|95.0|0.43|1.06|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.06|0.43|0.0861
71887032|NCT03434379|143294378|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0004|TWO_SIDED|95.0|0.33|0.74|||Log Rank|||Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.74|0.33|0.0004
71887033|NCT03434379|143294379|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0035|TWO_SIDED|95.0|0.26|0.78|||Log Rank|||Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.78|0.26|0.0035
71887034|NCT03434379|143294379|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.2214|TWO_SIDED|95.0|0.42|1.23|||Log Rank|||Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||1.23|0.42|0.2214
71887035|NCT03434379|143294379|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0135|TWO_SIDED|95.0|0.32|0.88|||Log Rank|||GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).||0.88|0.32|0.0135
71887036|NCT00466310|143294409|SUPERIORITY_OR_OTHER|||||||0.0149|TWO_SIDED|95.0||||Unadjusted p value is .0041|Wilcoxon (Mann-Whitney)|||A wilcoxon rank sum test was performed comparing baseline plasmalogen values, comparing schizophrenia subjects vs controls.P values from this analysis were adjusted for false discovery rates by the method of Storey and Tribshiani.||||0.0149
71887037|NCT00762515|143294416|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline is used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
71767725|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.091||0.135|TWO_SIDED|95.0|-0.043|0.317||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.317|-0.043|0.135
71828436|NCT01212757|143161382|SUPERIORITY||Adjusted Difference|1.3||||0.8462|TWO_SIDED|95.0|-12.1|14.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.|||14.7|-12.1|0.8462
71887038|NCT00762515|143294417|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|baseline to be used a factor||The null hypothesis states that there is no difference between groups.||||<0.05
71887039|NCT01227902|143294463|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.1|52.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||52.9|27.1|
71887040|NCT01227902|143294463|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|19.1|44.9|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||44.9|19.1|
71887041|NCT01227902|143294463|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.2|64.8|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||64.8|35.2|
71887042|NCT01227902|143294463|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|43.3|70.5|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||70.5|43.3|
71828437|NCT01212757|143161383|SUPERIORITY||Adjusted Difference|2.8||||0.7337|TWO_SIDED|95.0|-13.3|18.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-13.3|0.7337
71828438|NCT01212757|143161383|SUPERIORITY||Adjusted Difference|3.3||||0.6881|TWO_SIDED|95.0|-12.7|19.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-12.7|0.6881
71887043|NCT01227902|143294463|SUPERIORITY_OR_OTHER||percentage of participants|44.5|||||TWO_SIDED|95.0|37.6|51.4|||||The estimated value represents the percentage of participants with a \>=50% reduction in partial-onset seizure frequency from Baseline.|||51.4|37.6|
71887044|NCT00930059|143294505|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.73||0.3353|TWO_SIDED|90.0|-1.52|0.9||The primary test of significance was 1-sided, and a nominal Type I error rate a = 0.05 was employed.|ANCOVA|||Least squares (LS) mean difference and p-values were based on analysis of covariance (ANCOVA) on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.90|-1.52|0.3353
71828439|NCT01212757|143161384|SUPERIORITY||Adjusted Difference|17.5||||0.0014|TWO_SIDED|95.0|7.0|27.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|7.0|0.0014
71828440|NCT01212757|143161384|SUPERIORITY||Adjusted Difference|22.1||||0.0001|TWO_SIDED|95.0|11.7|32.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||32.5|11.7|0.0001
71715860|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||4.7|2.0|<0.0001
71715861|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED|95.0|2.7|6.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.8|2.7|<0.0001
71715862|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.4014|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.4014
71715863|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.0001|TWO_SIDED|95.0|2.3|5.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||5.5|2.3|<0.0001
71715864|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.0001|TWO_SIDED|95.0|2.9|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.2|2.9|<0.0001
71715865|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.2824|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.2824
71715866|NCT00565409|142946530|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.5|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.9|2.5|<0.0001
71715867|NCT00565409|142946531|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71715868|NCT00565409|142946531|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71715869|NCT00565409|142946531|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71715870|NCT00565409|142946531|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71828441|NCT01212757|143161385|SUPERIORITY||Adjusted Difference|6.6||||0.3376|TWO_SIDED|95.0|-6.8|20.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.0|-6.8|0.3376
71828442|NCT01212757|143161385|SUPERIORITY||Adjusted Difference|6.1||||0.3756|TWO_SIDED|95.0|-7.2|19.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.4|-7.2|0.3756
71828443|NCT01212757|143161386|SUPERIORITY||Adjusted Difference|6.8||||0.3959|TWO_SIDED|95.0|-8.7|22.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.2|-8.7|0.3959
71828444|NCT01212757|143161386|SUPERIORITY||Adjusted Difference|6.8||||0.3941|TWO_SIDED|95.0|-8.7|22.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-8.7|0.3941
71828445|NCT01212757|143161387|SUPERIORITY||Adjusted Difference|12.1||||0.0142|TWO_SIDED|95.0|2.6|21.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.7|2.6|0.0142
71828446|NCT01212757|143161387|SUPERIORITY||Adjusted Difference|20.5||||0.0001|TWO_SIDED|95.0|10.8|30.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.3|10.8|0.0001
71887045|NCT00930059|143294506|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.72||0.6073|TWO_SIDED|90.0|-0.99|1.38||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.38|-0.99|0.6073
71715871|NCT00565409|142946531|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71715872|NCT00565409|142946531|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||week 36||||<0.0001
71715873|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0575|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0575
71715874|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.063|TWO_SIDED|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||2.3|1.0|0.0630
71715875|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.916|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.6|0.7|0.9160
71715876|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0147|TWO_SIDED|95.0|1.0|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.0|0.0147
71715877|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.8675|TWO_SIDED|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.6|0.6|0.8675
71828447|NCT01212757|143161388|SUPERIORITY||Adjusted Difference|5.6||||0.0589|TWO_SIDED|95.0|-0.2|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||11.3|-0.2|0.0589
71715878|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0174|TWO_SIDED|95.0|1.1|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.0|1.1|0.0174
71715879|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.0001|TWO_SIDED|95.0|1.9|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||5.7|1.9|<0.0001
71715880|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.4941|TWO_SIDED|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||1.3|0.5|0.4941
71715881|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.3|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.0|2.3|<0.0001
71715882|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||5.9|2.0|<0.0001
71715883|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8185|TWO_SIDED|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||1.5|0.6|0.8185
71715884|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||6.4|2.1|<0.0001
71715885|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.2|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||6.6|2.2|<0.0001
71715886|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4254|TWO_SIDED|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.8|0.7|0.4254
71715887|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|1.9|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||5.9|1.9|<0.0001
71715888|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.8|5.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||5.8|1.8|<0.0001
71715889|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8766|TWO_SIDED|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.7|0.8766
71715890|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||6.4|2.1|<0.0001
71715891|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.0|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.4|2.0|<0.0001
71715892|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.3535|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.8|0.3535
71715893|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.0001|TWO_SIDED|95.0|1.9|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||6.1|1.9|<0.0001
71715894|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.0001|TWO_SIDED|95.0|2.0|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||6.1|2.0|<0.0001
71715895|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.3231|TWO_SIDED|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||1.9|0.8|0.3231
71715896|NCT00565409|142946532|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|1.9|5.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||5.6|1.9|<0.0001
71715897|NCT00565409|142946533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4||||<0.0001
71715898|NCT00565409|142946533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8||||<0.0001
71715899|NCT00565409|142946533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||<0.0001
71715900|NCT00565409|142946533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 20||||<0.0001
71715901|NCT00565409|142946533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||<0.0001
71767726|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71715902|NCT00565409|142946533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 36||||<0.0001
71715903|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14||||0.0089|TWO_SIDED|95.0|0.9|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||5.2|0.9|0.0089
71715904|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6932|TWO_SIDED|95.0|0.5|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||1.7|0.5|0.6932
71715905|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.76||||0.0019|TWO_SIDED|95.0|1.2|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36||6.1|1.2|0.0019
71715906|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.0797|TWO_SIDED|95.0|0.6|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||3.6|0.6|0.0797
71715907|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8103|TWO_SIDED|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||1.9|0.4|0.8103
71715908|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.0903|TWO_SIDED|95.0|0.8|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40||4.5|0.8|0.0903
71715909|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0035|TWO_SIDED|95.0|1.2|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||7.8|1.2|0.0035
71715910|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.977|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||2.0|0.5|0.9770
71767727|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.117||0.713|TWO_SIDED|95.0|-0.273|0.187||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.187|-0.273|0.713
71767728|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71715911|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0036|TWO_SIDED|95.0|1.3|8.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48||8.3|1.3|0.0036
71715912|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.0038|TWO_SIDED|95.0|1.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||7.7|1.0|0.0038
71715913|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9055|TWO_SIDED|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||2.0|0.5|0.9055
71715914|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.002|TWO_SIDED|95.0|1.2|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56||9.8|1.2|0.0020
71715915|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35||||0.002|TWO_SIDED|95.0|1.3|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||8.8|1.3|0.0020
71715916|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.5763|TWO_SIDED|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||1.7|0.4|0.5763
71828448|NCT01212757|143161388|SUPERIORITY||Adjusted Difference|9.8||||0.0034|TWO_SIDED|95.0|3.4|16.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|3.4|0.0034
71715917|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93||||0.0002|TWO_SIDED|95.0|1.5|10.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64||10.0|1.5|0.0002
71715918|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21||||0.0004|TWO_SIDED|95.0|1.2|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||8.8|1.2|0.0004
71715919|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.4828|TWO_SIDED|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||1.6|0.4|0.4828
71715920|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|1.4|9.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72||9.0|1.4|<0.0001
71767729|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.318|TWO_SIDED|95.0|-0.341|0.111||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.111|-0.341|0.318
71715921|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.0002|TWO_SIDED|95.0|1.4|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||7.8|1.4|0.0002
71715922|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8553|TWO_SIDED|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||1.9|0.6|0.8553
71715923|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56||||0.0003|TWO_SIDED|95.0|1.5|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80||8.7|1.5|0.0003
71715924|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|1.6|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||7.6|1.6|<0.0001
71715925|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.5025|TWO_SIDED|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||2.0|0.6|0.5025
71715926|NCT00565409|142946534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62||||0.0001|TWO_SIDED|95.0|1.6|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88||8.1|1.6|0.0001
71715927|NCT01918189|142946597|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline.||||||0.008||||||a priori threshold for statistical significance is p \<0.05|Regression, Logistic|||||||0.008
71715928|NCT01918189|142946598|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain intensity at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.27|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.27
71887046|NCT00930059|143294506|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.73||0.3086|TWO_SIDED|90.0|-1.56|0.84||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.84|-1.56|0.3086
71887047|NCT00930059|143294506|SUPERIORITY||LS mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.73||0.197|TWO_SIDED|90.0|-1.82|0.58||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||0.58|-1.82|0.1970
71715929|NCT01918189|142946599|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.02|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.02
71887048|NCT00930059|143294507|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6547|TWO_SIDED|90.0|-0.18|0.29||No adjustments made for multiple comparisons.|Linear model|||Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.29|-0.18|0.6547
71715930|NCT01918189|142946600|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.48|TWO_SIDED|||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.48
71715931|NCT01918189|142946601|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of sleep at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.18|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.18
71715932|NCT01918189|142946602|OTHER|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of depression symptoms at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.03|TWO_SIDED|95.0||||a priori threshold for statistical significance is p\<0.05|Regression, Logistic|||||||0.03
71715933|NCT01657305|142946603|SUPERIORITY_OR_OTHER||||||<|0.0001||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.~Negative values for the intra-individual time difference indicate faster healing of the Oleogel-S10-treated wound half.~For right-censored observations (no wound closure observed in blinded photo evaluation), wound closure was conservatively calculated as +1 day after the last photo."||||<0.0001
71715934|NCT01657305|142946607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|13.4|<|0.0001|TWO_SIDED|95.0|6.0|11.2||Day 7|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.2|6.0|<0.0001
71887049|NCT00930059|143294507|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.702|TWO_SIDED|90.0|-0.16|0.31||No adjustments made for multiple comparisons.|Linear model|||Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.31|-0.16|0.7020
71715935|NCT01657305|142946607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|6.9|13.4||Day 10|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||13.4|6.9|<0.0001
71715936|NCT01657305|142946607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|STANDARD_DEVIATION|17.0|<|0.0001|TWO_SIDED|95.0|4.6|11.1||Day 14|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||11.1|4.6|<0.0001
71715937|NCT01657305|142946607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|3.9|10.9||Day 18|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||10.9|3.9|<0.0001
71715938|NCT01657305|142946607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_DEVIATION|14.1|<|0.0001|TWO_SIDED|95.0|3.7|9.1||Day 21|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||9.1|3.7|<0.0001
71715939|NCT01657305|142946607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|12.9|=|0.0021|TWO_SIDED|95.0|1.5|6.4||Day 28|t-test, 2 sided||Difference in degree of epithelialization \[%\] (Oleogel-S10 minus standard of care)|||6.4|1.5|=0.0021
71715940|NCT01180127|142946638|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Repeated measures ANOVA|||Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.||||.0001
71715941|NCT01180127|142946639|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED|||||The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise|ANCOVA|||ANCOVA used to test main effect of flavanol||||0.038
71715942|NCT01180127|142946639|SUPERIORITY_OR_OTHER|||||||0.815|TWO_SIDED|||||The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol|ANCOVA|||ANCOVA used to test main effect of exercise||||0.815
71887050|NCT00930059|143294507|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.1138|TWO_SIDED|90.0|-0.41|0.06||No adjustments made for multiple comparisons.|Linear model|||Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.06|-0.41|0.1138
71715943|NCT01180127|142946640|SUPERIORITY_OR_OTHER|||||||0.853|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of flavanol||||0.853
71887051|NCT00930059|143294507|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.0816|TWO_SIDED|90.0|-0.44|0.04||No adjustments made for multiple comparisons.|Linear model|||Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.||0.04|-0.44|0.0816
71887052|NCT00930059|143294509|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.96||0.7634|TWO_SIDED|90.0|-0.89|2.27||No adjustments have been made for multiple comparisons.|ANCOVA|||Change at Week 3: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.27|-0.89|0.7634
71887053|NCT00930059|143294509|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|0.97||0.8077|TWO_SIDED|90.0|-0.75|2.45||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 6: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.45|-0.75|0.8077
71715944|NCT01180127|142946640|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED||||||ANCOVA|||ANCOVA for testing main effect of exercise||||0.581
71767730|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71715945|NCT01180127|142946641|SUPERIORITY_OR_OTHER|||||||0.237|TWO_SIDED||||||ANCOVA|||ANCOVA was used to test for an exercise effect.||||0.237
71715946|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-2.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
71715947|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||3|-6|
71767731|NCT02880956|143037258|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.119||0.927|TWO_SIDED|95.0|-0.244|0.222||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.222|-0.244|0.927
71767732|NCT02880956|143037258|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71715948|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
71715949|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-4.0|5.0||||||Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||5|-4|
71715950|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|5.0|||||TWO_SIDED|95.0|1.0|10.0||||||Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||10|1|
71715951|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||||||Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|-6|
71715952|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-16.0|||||TWO_SIDED|95.0|-21.0|-10.0||||||Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||-10|-21|
71715953|NCT00518180|142946648|NON_INFERIORITY_OR_EQUIVALENCE|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||TWO_SIDED|95.0|-9.0|1.0||||||Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-9|
71715954|NCT00518180|142946649|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|2.0|||||TWO_SIDED|95.0|1.0|4.0||||||Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||4|1|
71715955|NCT00518180|142946649|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL \[Group I minus Group III\] were greater than -10%.|Vaccine Group differences (%)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.||1|-1|
71715956|NCT00518180|142946658|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.9|0.72|
71715957|NCT00518180|142946658|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.68|||||TWO_SIDED|95.0|0.58|0.81||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.81|0.58|
71715958|NCT00518180|142946658|NON_INFERIORITY_OR_EQUIVALENCE|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was \> 0.67.|Vaccine Group Ratio|0.67|||||TWO_SIDED|95.0|0.58|0.76||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.||0.76|0.58|
71767733|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.081||0.456|TWO_SIDED|95.0|-0.219|0.098||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.098|-0.219|0.456
71767734|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767735|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.079||0.093|TWO_SIDED|95.0|-0.29|0.023||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.023|-0.290|0.093
71828449|NCT01212757|143161389|SUPERIORITY||Adjusted Difference|0.6||||0.562|TWO_SIDED|95.0|-1.5|2.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||2.7|-1.5|0.5620
71828450|NCT01212757|143161389|SUPERIORITY||Adjusted Difference|3.1||||0.057|TWO_SIDED|95.0|0.0|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.2|-0.0|0.0570
71828451|NCT01212757|143161390|SUPERIORITY||Adjusted Difference|3.1||||0.3629|TWO_SIDED|95.0|-3.5|9.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.6|-3.5|0.3629
71715959|NCT03060902|142946661|SUPERIORITY||F|10.16||||0.002|TWO_SIDED||||||ANOVA|||||||.002
71715960|NCT02972996|142946691|OTHER|||||||0.56|||||||ANCOVA|||Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.||||0.56
71715961|NCT02972996|142946692|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
71828452|NCT01212757|143161390|SUPERIORITY||Adjusted Difference|5.4||||0.1323|TWO_SIDED|95.0|-1.5|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||12.3|-1.5|0.1323
71828453|NCT01212757|143161391|SUPERIORITY||Adjusted Difference|-0.6||||0.7273|TWO_SIDED|95.0|-4.3|3.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||3.0|-4.3|0.7273
71715962|NCT03961308|142946710|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0734|||||TWO_SIDED|90.0|0.9963|1.1565||||||||1.1565|0.9963|
71715963|NCT03961308|142946711|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0824|||||TWO_SIDED|90.0|1.0169|1.1521||||||||1.1521|1.0169|
71767736|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767737|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.082||0.75|TWO_SIDED|95.0|-0.187|0.135||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.135|-0.187|0.750
71828454|NCT01212757|143161391|SUPERIORITY||Adjusted Difference|2.4||||0.2929|TWO_SIDED|95.0|-2.0|6.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.8|-2.0|0.2929
71715964|NCT03961308|142946712|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0465|||||TWO_SIDED|90.0|0.9935|1.1023||||||||1.1023|0.9935|
71715965|NCT01174563|142946726|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.41|0.83|||Log Rank|||||0.83|0.41|0.005
71715966|NCT01347060|142946737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0051|TWO_SIDED|95.0|0.68|0.93||The P-value relates to differences in combined inpatient/emergency department.|Regression, Cox|Adjusted for baseline differences||||0.93|0.68|0.0051
71715967|NCT01347060|142946738|SUPERIORITY_OR_OTHER||Mean Difference (Net)|883.23||||0.001|TWO_SIDED|95.0|731.66|1041.69||The P-value is on the adjusted difference in total asthma costs.|Regression, Linear|Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline||||1041.69|731.66|0.001
71767738|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767739|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.106||0.134|TWO_SIDED|95.0|-0.049|0.366||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.366|-0.049|0.134
71715968|NCT01347060|142946739|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71715969|NCT01542788|142946746|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by presence or absence of cirrhosis for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 180 subjects in the active group and 60 in the placebo group would provide 99% power to detect a difference between group SVR12 rates of 40% using a 2-sided continuity-corrected chi-square test at significance level of 0.05.||83.6|71.0|< 0.001
71715970|NCT01542788|142946748|SUPERIORITY_OR_OTHER||Proportion difference|82.7|||||TWO_SIDED|95.0|76.8|88.5|||||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||88.5|76.8|
71715971|NCT01542788|142946749|SUPERIORITY_OR_OTHER||Proportion difference|77.3|||<|0.001|TWO_SIDED|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by randomization stratification factor for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||83.6|71.0|< 0.001
71715972|NCT04704193|142946756|OTHER|This arm includes descriptive statistics only.|count with proportion|0.955|||||TWO_SIDED|95.0|0.888|0.987||||||"Descriptive statistics only/proportion reported good or excellent~Q1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk"||.987|.888|
71715973|NCT04704193|142946756|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1b. Genetic test results may help guide my treatment options"||.974|.856|
71715974|NCT04704193|142946756|OTHER|This arm includes descriptive statistics only.|count with proportion|0.943|||||TWO_SIDED|95.0|0.872|0.981||||||"Descriptive statistics only/proportion reported good or excellent~Q1c. Genetic test results may help me understand the future risks of other cancers"||.981|.872|
71715975|NCT04704193|142946756|OTHER|This arm includes descriptive statistics only.|count with proportion|0.851|||||TWO_SIDED|95.0|0.758|0.918||||||"Descriptive statistics only/proportion reported good or excellent~Q1d. Genetic test results may increase stress to me and my family members"||.918|.758|
71715976|NCT04704193|142946756|OTHER|This arm includes descriptive statistics only.|count with proportion|0.931|||||TWO_SIDED|95.0|0.856|0.974||||||"Descriptive statistics only/proportion reported good or excellent~Q1e. There are 3 gene panel options that include either a small, medium, or large number of genes"||.974|.856|
71828455|NCT01212757|143161392|SUPERIORITY||Adjusted Difference|-2.2||||0.7023|TWO_SIDED|95.0|-13.5|9.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||9.1|-13.5|0.7023
71828456|NCT01212757|143161392|SUPERIORITY||Adjusted Difference|5.9||||0.3305|TWO_SIDED|95.0|-5.9|17.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.7|-5.9|0.3305
71828457|NCT01212757|143161393|SUPERIORITY||Adjusted Difference|0.3||||0.9698|TWO_SIDED|95.0|-16.0|16.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.6|-16.0|0.9698
71828458|NCT01212757|143161393|SUPERIORITY||Adjusted Difference|1.9||||0.8205|TWO_SIDED|95.0|-14.3|18.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.1|-14.3|0.8205
71828459|NCT01212757|143161394|SUPERIORITY||Adjusted Difference|-1.2||||0.8424|TWO_SIDED|95.0|-12.7|10.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||10.3|-12.7|0.8424
71828460|NCT01212757|143161394|SUPERIORITY||Adjusted Difference|5.9||||0.3395|TWO_SIDED|95.0|-6.0|17.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.8|-6.0|0.3395
71828461|NCT01212757|143161395|SUPERIORITY||Adjusted Difference|5.9||||0.4811|TWO_SIDED|95.0|-10.3|22.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.1|-10.3|0.4811
71715977|NCT04704193|142946756|OTHER|This arm includes descriptive statistics only.|count with proportion|0.919|||||TWO_SIDED|95.0|0.839|0.967||||||"Descriptive statistics only/proportion reported good or excellent~Q1f. Gene test results may come back as positive, negative or uncertain"||.967|.839|
71715978|NCT04704193|142946757|OTHER|Summary statistics only|Mean|13.7|STANDARD_DEVIATION|5.6|||TWO_SIDED|||||||||||||
71715979|NCT00542178|142946758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.003|TWO_SIDED|95.0|0.51|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control||0.87|0.51|0.003
71715980|NCT00542178|142946758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.29|TWO_SIDED|95.0|0.84|1.79|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control||1.79|0.84|0.29
71715981|NCT00542178|142946758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.006|TWO_SIDED|95.0|0.42|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone||0.87|0.42|0.006
71715982|NCT00542178|142946759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.997||||0.96|TWO_SIDED|95.0|0.901|1.104|||Regression, Cox|||||1.104|0.901|0.96
71715983|NCT00542178|142946759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.5|TWO_SIDED|95.0|0.825|1.099|||Regression, Cox|||||1.099|0.825|0.50
71715984|NCT00542178|142946759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.762|1.016|||Regression, Cox|||||1.016|0.762|0.08
71715985|NCT00542178|142946760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.0355|TWO_SIDED|95.0|0.788|0.992|||Regression, Cox|||||0.992|0.788|0.0355
71715986|NCT00542178|142946760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891||||0.17|TWO_SIDED|95.0|0.755|1.051|||Regression, Cox|||||1.051|0.755|0.17
71715987|NCT00542178|142946760|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.86|TWO_SIDED|95.0|0.865|1.19|||Regression, Cox|||||1.190|0.865|0.86
71715988|NCT00542178|142946761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.069|TWO_SIDED|95.0|0.71|1.69|||Regression, Logistic|||||1.69|0.71|0.069
71715989|NCT00542178|142946761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.63|TWO_SIDED|95.0|0.44|1.63|||Regression, Logistic|||||1.63|0.44|0.63
71715990|NCT00542178|142946761|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.78|TWO_SIDED|95.0|0.6|1.96|||Regression, Logistic|||||1.96|0.60|0.78
71715991|NCT03449576|142946762|SUPERIORITY||Slope|5.3846|STANDARD_ERROR_OF_MEAN|6.5525||0.4154|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the CAPS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4154
71715992|NCT03449576|142946763|SUPERIORITY||Slope|0.267397|STANDARD_ERROR_OF_MEAN|0.362521||0.4636|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the SAS-SR score-- with the interaction between Visit (pre/post) and Treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.4636
71715993|NCT03449576|142946764|SUPERIORITY||Slope|2.3355|STANDARD_ERROR_OF_MEAN|6.8791||0.735129|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the PCL score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.735129
71715994|NCT03449576|142946765|SUPERIORITY||Slope|-2.64908|STANDARD_ERROR_OF_MEAN|4.76601||0.58|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the AQ score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.580
71715995|NCT03449576|142946766|SUPERIORITY||Slope|1.3946|STANDARD_ERROR_OF_MEAN|5.7193||0.808|TWO_SIDED|||||This P value is the interaction term between Visit and Treatment.|Regression, Linear||This is the beta value for the interaction term between Visit and Treatment.|Test of prediction of dependent variable -- the ITS score-- with the interaction between Visit (pre/post) and treatment type (TMT vs. EXP+EDU), as well as independent variable, age||||0.808
71715996|NCT01978145|142946779|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by CB DPI versus FSC administered BID by MD DPI is greater than -45 milliliter (mL).|Mean Difference (Net)|0.025|||||TWO_SIDED|95.0|0.002|0.047|||Repeated Measures Mixed Models|||||0.047|0.002|
71715997|NCT01978145|142946780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.019|0.027|||||The estimated value and 95% CI values are provided for Day 28|||0.027|-0.019|
71715998|NCT01978145|142946780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|||||TWO_SIDED|95.0|-0.005|0.044|||||The estimated value and 95% CI values are provided for Day 56|||0.044|-0.005|
71715999|NCT01978145|142946781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166||||||95.0|-0.06|0.393||||||||0.393|-0.060|
71716000|NCT01978145|142946782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.278|0.272|||||The estimated and 95% CI values are presented for Day 28.|||0.272|-0.278|
71716001|NCT01978145|142946782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.069||||||95.0|-0.349|0.212|||||The estimated and 95% CI values are presented for Day 56.|||0.212|-0.349|
71716002|NCT01978145|142946782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.133|||||TWO_SIDED|95.0|-0.413|0.148|||||The estimated and 95% CI values are presented for Day 85.|||0.148|-0.413|
71716003|NCT01978145|142946783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.7|1.19||||||||1.19|-0.70|
71716004|NCT01978145|142946784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.1|-0.02||||||||-0.02|-1.10|
71716005|NCT02777086|142946789|SUPERIORITY||||||<|0.001|||||||ANCOVA|||3-month outcome measures were compared between the StaySafe and Comparison groups controlling for the baseline measure using generalized linear models.||||<.001
71716006|NCT02122380|142946835|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of mean growth hormone (GH) levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided). A sample size of 16 participants was needed to provide 93% power to detect a difference in GH means of 0.5 mcg/L.||||0.918
71716007|NCT02122380|142946836|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of early insulin secretion between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.054
71716008|NCT02122380|142946837|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in blood glucose levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).||||0.009
71716009|NCT02122380|142946838|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in the mass of visceral adipose tissue after sitagliptin vs. placebo. The test was performed with a significance level of 0.05 (two sided).||||0.022
71716010|NCT02122380|142946839|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in vascular function between sitagliptin and placebo treatments. The test was performed with a significance level of 0.05 (two sided).||||0.943
71716011|NCT00272792|142946840|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||<0.001
71716012|NCT00272792|142946840|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||Compared Week 10 to Baseline.||||0.027
71716013|NCT00272792|142946841|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Longitudinal Model|Longitudinal model with blood Phe measurements as the response variable and treatment group, visit, and baseline blood Phe level as covariates.||||||0.009
71716014|NCT02921789|142946842|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||9.0|-34.5|0.3705
71716015|NCT02921789|142946843|SUPERIORITY||Difference|-12.7||||0.3705|TWO_SIDED|95.0|-34.5|9.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||9.0|-34.5|0.3705
71716016|NCT02921789|142946843|SUPERIORITY||Difference|-12.4||||0.389|TWO_SIDED|95.0|-35.8|11.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||11.0|-35.8|0.3890
71716017|NCT02921789|142946844|SUPERIORITY||Difference|6.9||||0.752|TWO_SIDED|95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||29.2|-15.3|0.7520
71716018|NCT02921789|142946844|SUPERIORITY||Difference|6.9||||0.752||95.0|-15.3|29.2||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||29.2|-15.3|0.7520
71716019|NCT02921789|142946844|SUPERIORITY||Difference|5.0||||0.7597|TWO_SIDED|95.0|-18.9|29.0||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||29.0|-18.9|0.7597
71716020|NCT02921789|142946845|SUPERIORITY||Difference|-0.3||||1||95.0|-24.9|24.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||||24.3|-24.9|1.0
71716021|NCT02921789|142946846|SUPERIORITY||Difference|-3.9||||1||95.0|-30.2|22.4||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 3||22.4|-30.2|1.0
71716022|NCT02921789|142946846|SUPERIORITY||Difference|-6.2||||0.772||95.0|-31.7|19.3||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 6||19.3|-31.7|0.7720
71716023|NCT02921789|142946846|SUPERIORITY||Difference|-7.5||||0.772||95.0|-32.6|17.6||Incidence rate comparisons are based on Fisher's Exact test and confidence intervals are based on Normal Approximation.|Fisher Exact|||Month 12||17.6|-32.6|0.7720
71716024|NCT01766102|142946855|OTHER|||||||0.716|||||||t-test, 2 sided|||H0: Procedure time is not significantly different based on mammography type used||||0.716
71716025|NCT01766102|142946855|OTHER|||||||0.676|||||||t-test, 2 sided|||H0: Operating room time is not significantly different based on mammography type used||||0.676
71716026|NCT03423602|142946859|NON_INFERIORITY|Based on a Meta-Analysis of a focused systematic literature review from a comparable patient population, the estimated major vascular access site complication rate or PGsafety for the conservative Random Effect Model is 0.125 with a 95% Confidence Interval of 0.09 to 0.17. Given that the upper bound was 0.17 this justified the use of 0.13 as a valid PGsafety plus a non-inferiority margin of 0.04 yielding an overall non-inferiority limit (NLs) of 0.17 for Safety. Study power is greater than 90%|Wilson's exact test|0.0487|||<|0.0001|ONE_SIDED|95.0||0.0487|||Wilson's exact test|All 75 enrolled subjects, regardless of their enrolment status at 1-month post implantation, including all reported safety data where included.||"The test for non-inferiority for safety was based on a one-sided test (at the 0.025 significance level) for a binomial proportion with hypotheses:~H0s: Psafety ≥ NLs versus H1s: Psafety \< NLs Where: Psafety is the actual proportion of device related major vascular access site complications within the study population; and NLs is the non-inferiority limit for proportion of expected major vascular access site complications associated with cut-down and suture closure."||0.0487||<.0001
71716027|NCT04790786|142946909|EQUIVALENCE|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||||||||||||Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound based on Bayesian probability.|Bayesian cumulative logistic model|Bayesian cumulative logistic model, Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.||The primary analysis model was a Bayesian cumulative logistic model that adjusted for treatment location (infusion center or ED), age (\<30, 30-39, 40-49, 50-59, 60-69, 70-79, and ≥ 80 years), sex, and time (2-week epochs). Comparisons between individual mAb were based on the relative odds ratio between a given two arms for the primary outcome. An odds ratio for an arm to a comparator \>1 implies improved outcomes. A sliding scale with different levels of equivalence bounds was pre-defined|Equivalence between two arms was defined as 95% posterior probability the odds ratio is within a given bound.|||
71716028|NCT02852967|142946929|SUPERIORITY|||||||0.6384|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 23) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6384
71716029|NCT02852967|142946929|SUPERIORITY|||||||0.6419|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID + placebo (n = 22) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.6419
71887054|NCT00930059|143294509|SUPERIORITY||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.98||0.835|TWO_SIDED|90.0|-0.66|2.57||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 9: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||2.57|-0.66|0.8350
71716030|NCT02852967|142946929|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 400 mg QD + placebo (n = 21) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||> 0.9999
71716031|NCT02852967|142946929|SUPERIORITY|||||||0.3859|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg (n = 26) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75.||||0.3859
71716032|NCT02852967|142946929|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||LOCF at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil (n = 92) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 18) who achieved PASI 75||||0.4435
71828462|NCT01212757|143161395|SUPERIORITY||Adjusted Difference|3.3||||0.6965|TWO_SIDED|95.0|-13.3|19.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.5|-13.3|0.6965
71716033|NCT02852967|142946929|SUPERIORITY|||||||0.2721|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg QD + placebo (n = 14) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.2721
71716034|NCT02852967|142946929|SUPERIORITY|||||||0.3577|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 200 mg BID+ Placebo (n = 15) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3577
71716035|NCT02852967|142946929|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 500 mg QD + Placebo (n = 17) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||> 0.9999
71828463|NCT04517864|143161415|SUPERIORITY||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.056|0.097||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.097|-0.056|
71828464|NCT04517864|143161416|SUPERIORITY||Least Squares Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0307|||TWO_SIDED|95.0|-0.052|0.07||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.070|-0.052|
71828465|NCT04517864|143161417|SUPERIORITY||Least Squares Mean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.0297|||TWO_SIDED|95.0|-0.065|0.053||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear Mixed-effects Model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.053|-0.065|
71828466|NCT04517864|143161419|SUPERIORITY||Least Squares Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.0235|||TWO_SIDED|95.0|-0.005|0.088||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||||0.088|-0.005|
71828467|NCT04517864|143161425|SUPERIORITY||Least Squares Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0224|||TWO_SIDED|95.0|-0.059|0.03||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.030|-0.059|
71828468|NCT04517864|143161425|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.107|-0.012||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||-0.012|-0.107|
71828469|NCT04517864|143161427|SUPERIORITY||Least Squares Mean Difference|-0.028|STANDARD_ERROR_OF_MEAN|0.0242|||TWO_SIDED|95.0|-0.076|0.02||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 6||0.020|-0.076|
71828470|NCT04517864|143161427|SUPERIORITY||Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|-0.049|0.056||There was no formal statistical hypothesis testing for this study, and hence there was no P-value.|Mixed Models Analysis|Linear mixed-effects model: baseline, treatment group, visit and treatment group by visit interaction as fixed effects; participant as a random effect||Month 9||0.056|-0.049|
71887055|NCT00930059|143294509|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.99||0.4377|TWO_SIDED|90.0|-1.78|1.48||No adjustments made for multiple comparisons.|ANCOVA|||Change at Week 12: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.||1.48|-1.78|0.4377
71887056|NCT01641120|143294582|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||<.05
71887057|NCT01641120|143294583|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.193
71716036|NCT02852967|142946929|SUPERIORITY|||||||0.3402|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of subjects treated with belumosudil 600 mg/day (n = 16) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3402
71716037|NCT02852967|142946929|SUPERIORITY|||||||0.3542|||||||Fisher Exact|||Observed at 16 weeks (Double-blind Treatment Period): Fisher's Exact Method analysis of the percentage of all subjects treated with belumosudil 200 mg QD + Placebo (n = 62) who achieved PASI 75 compared to the percentage of subjects treated with placebo (n = 10) who achieved PASI 75.||||0.3542
71716038|NCT02852967|142946933|SUPERIORITY|||||||0.5728|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5728
71716039|NCT02852967|142946933|SUPERIORITY|||||||0.1962|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.1962
71716040|NCT02852967|142946933|SUPERIORITY|Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear|||||>|0.9999|||||||Fisher Exact|||||||> 0.9999
71716041|NCT02852967|142946933|SUPERIORITY|||||||0.5583|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.5583
71716042|NCT02852967|142946933|SUPERIORITY|||||||0.2538|||||||Fisher Exact|||Percentage of subjects treated with belumosudil compared to placebo who had a PGA rating of clear or almost clear||||0.2538
71716043|NCT02136914|142946943|SUPERIORITY||Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.3||0.0009|TWO_SIDED|95.0|-12.5|-3.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-3.3|-12.5|0.0009
71716044|NCT02136914|142946944|SUPERIORITY||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|2.7||0.0008|TWO_SIDED|95.0|-14.7|-4.0|||Linear Mixed Model w/ Repeated Measures|||||-4.0|-14.7|0.0008
71716045|NCT02136914|142946945|SUPERIORITY||Least Squares Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|0.612|<|0.0001|TWO_SIDED|95.0|1.53|3.96||Change from Baseline in ON time without troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||3.96|1.53|<0.0001
71716046|NCT02136914|142946945|SUPERIORITY||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.634||0.0007|TWO_SIDED|95.0|0.96|3.47||Change from Baseline in ON time without troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||3.47|0.96|0.0007
71828471|NCT01049503|143161457|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni's test."||||<0.05
71887058|NCT01641120|143294584|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||0.035
71716047|NCT02136914|142946945|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.0171|TWO_SIDED|95.0|-1.64|-0.16||Change from Baseline in OFF time at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.16|-1.64|0.0171
71716048|NCT02136914|142946945|SUPERIORITY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0406|TWO_SIDED|95.0|-1.58|-0.04||Change from Baseline in OFF time at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.04|-1.58|0.0406
71716049|NCT02136914|142946945|SUPERIORITY||Least Squares Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.508||0.0031|TWO_SIDED|95.0|-2.55|-0.53||Change from Baseline in ON time with troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures|||||-0.53|-2.55|0.0031
71716050|NCT02136914|142946945|SUPERIORITY||Least Squares Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.526||0.0072|TWO_SIDED|95.0|-2.49|-0.4||Change from Baseline in ON time with troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures|||||-0.40|-2.49|0.0072
71716051|NCT02136914|142946946|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.74||0.6833|TWO_SIDED|95.0|-6.6|4.3||Change from Baseline in MDS-UPDRS at Week 12.|Linear Mixed Model w/ Repeated Measures|||||4.3|-6.6|0.6833
71716052|NCT02136914|142946946|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.58||0.5557|TWO_SIDED|95.0|-5.0|9.2||Change from Baseline in MDS-UPDRS at Week 24.|Linear Mixed Model w/ Repeated Measures|||||9.2|-5.0|0.5557
71716053|NCT02136914|142946947|SUPERIORITY||||||<|0.0001||||||Baseline to Week 12|Cochran-Mantel-Haenszel|||||||<0.0001
71716054|NCT02136914|142946947|SUPERIORITY|||||||0.1071||||||Baseline to Week 24|Cochran-Mantel-Haenszel|||||||0.1071
71716055|NCT03012334|142946957|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in Standard Deviation of Lateral Position (SDLP) between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|9.86|||<|0.001|TWO_SIDED|95.0|7.39|12.33||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||12.33|7.39|<.001
71716056|NCT03012334|142946957|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|15.35|||<|0.001|TWO_SIDED|95.0|12.87|17.82||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||17.82|12.87|<0.001
71716057|NCT03012334|142946957|NON_INFERIORITY|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|21.06|||<|0.001|TWO_SIDED|95.0|18.6|23.52||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis|||||23.52|18.60|<0.001
71716058|NCT03012334|142946957|SUPERIORITY||LS Mean|22.71|||<|0.001|TWO_SIDED|95.0|20.23|25.18|||Mixed Models Analysis|||||25.18|20.23|<0.001
71716059|NCT03012334|142946957|SUPERIORITY||LS Mean|-12.85|||<|0.001|TWO_SIDED|95.0|-15.32|-10.38|||Mixed Models Analysis|||||-10.38|-15.32|<0.001
71716060|NCT03012334|142946957|SUPERIORITY||LS Mean|-7.36|||<|0.001|TWO_SIDED|95.0|-9.84|-4.88|||Mixed Models Analysis|||||-4.88|-9.84|<0.001
71716061|NCT03012334|142946957|SUPERIORITY||LS Mean|-1.65||||0.19|TWO_SIDED|95.0|-4.11|0.82|||Mixed Models Analysis|||||0.82|-4.11|0.19
71716062|NCT03012334|142946958|SUPERIORITY||LS Mean|1.6|||<|0.0001|TWO_SIDED|95.0|1.1744|2.0335|||Mixed Models Analysis|||||2.0335|1.1744|<0.0001
71716063|NCT03012334|142946958|SUPERIORITY||LS Mean|2.3|||<|0.0001|TWO_SIDED|95.0|1.8306|2.6926|||Mixed Models Analysis|||||2.6926|1.8306|<.0001
71887059|NCT01641120|143294585|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Ranks|||||||.005
71716064|NCT03012334|142946958|SUPERIORITY||LS Mean|2.9|||<|0.0001|TWO_SIDED|95.0|2.4239|3.28|||Mixed Models Analysis|||||3.2800|2.4239|<0.0001
71716065|NCT03012334|142946958|SUPERIORITY||LS Mean|3.4|||<|0.0001|TWO_SIDED|95.0|2.9568|3.8193|||Mixed Models Analysis|||||3.8193|2.9568|<0.0001
71716066|NCT03012334|142946958|SUPERIORITY||LS Mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2137|-1.3546|||Mixed Models Analysis|||||-1.3546|-2.2137|<0.0001
71716067|NCT03012334|142946958|SUPERIORITY||LS Mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5574|-0.6956|||Mixed Models Analysis|||||-0.6956|-1.5574|<0.0001
71716068|NCT03012334|142946958|SUPERIORITY||LS Mean|-0.5||||0.0142|TWO_SIDED|95.0|-0.9642|-0.1081|||Mixed Models Analysis|||||-0.1081|-0.9642|0.0142
71716069|NCT03012334|142946960|SUPERIORITY||LS Mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-18.6895|-6.5006|||Mixed Models Analysis|||||-6.5006|-18.6895|<.0001
71716070|NCT03012334|142946960|SUPERIORITY||LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-30.3631|-18.1357|||Mixed Models Analysis|||||-18.1357|-30.3631|<.0001
71716071|NCT03012334|142946960|SUPERIORITY||LS Mean|-28.4|||<|0.0001|TWO_SIDED|95.0|-34.442|-22.2897|||Mixed Models Analysis|||||-22.2897|-34.4420|<.0001
71716072|NCT03012334|142946960|SUPERIORITY||LS Mean|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.5068|-24.277|||Mixed Models Analysis|||||-24.2770|-36.5068|<0.0001
71767740|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71716073|NCT03012334|142946960|SUPERIORITY||LS Mean|17.8|||<|0.0001|TWO_SIDED|95.0|11.7029|23.8908|||Mixed Models Analysis|||||23.8908|11.7029|<.0001
71828472|NCT01049503|143161458|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
71828473|NCT01049503|143161459|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
71828474|NCT01049503|143161460|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey's test."||||<0.05
71828475|NCT01049503|143161461|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn's tests.||||<0.05
71828476|NCT01049503|143161462|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey's test.||||<0.05
71828477|NCT01049503|143161463|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.||||<0.05
71828478|NCT02974634|143161464|SUPERIORITY||Slope|1.04|STANDARD_ERROR_OF_MEAN|2.32||0.06|TWO_SIDED|95.0|-3.5|5.6||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||5.6|-3.5|0.06
71828479|NCT02974634|143161465|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.68|TWO_SIDED|95.0|-0.24|0.91||Comparison of intervention and usual care at 6 month follow up|t-test, 2 sided||Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model|||0.91|-0.24|0.68
71828480|NCT00004124|143161501|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|||||1.43|0.79|0.70
71887060|NCT03195517|143294595|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71716074|NCT03012334|142946960|SUPERIORITY||LS Mean|6.1||||0.0489|TWO_SIDED|95.0|0.0297|12.2554|||Mixed Models Analysis|||||12.2554|0.0297|0.0489
71716075|NCT03012334|142946960|SUPERIORITY||LS Mean|2.0||||0.5123|TWO_SIDED|95.0|-4.05|8.1021|||Mixed Models Analysis|||||8.1021|-4.0500|0.5123
71716076|NCT03012334|142946960|SUPERIORITY||LS Mean|-26.4|||<|0.0001|TWO_SIDED|95.0|-32.4956|-20.3628|||Mixed Models Analysis|||||-20.3628|-32.4956|<.0001
71716077|NCT03012334|142946960|SUPERIORITY||LS Mean|-37.8|||<|0.0001|TWO_SIDED|95.0|-43.927|-31.7537|||Mixed Models Analysis|||||-31.7537|-43.9270|<.0001
71716078|NCT03012334|142946960|SUPERIORITY||LS Mean|-46.8|||<|0.0001|TWO_SIDED|95.0|-52.8147|-40.7268|||Mixed Models Analysis|||||-40.7268|-52.8147|<.0001
71716079|NCT03012334|142946960|SUPERIORITY||LS Mean|-52.6|||<|0.0001|TWO_SIDED|95.0|-58.649|-46.4682|||Mixed Models Analysis|||||-46.4682|-58.6490|<0.0001
71767741|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.103||0.316|TWO_SIDED|95.0|-0.099|0.305||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.305|-0.099|0.316
71887061|NCT03195517|143294596|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71716080|NCT03012334|142946960|SUPERIORITY||LS Mean|26.1|||<|0.0001|TWO_SIDED|95.0|20.0635|32.1953|||Mixed Models Analysis|||||32.1953|20.0635|<.0001
71716081|NCT03012334|142946960|SUPERIORITY||LS Mean|14.7|||<|0.0001|TWO_SIDED|95.0|8.6325|20.804|||Mixed Models Analysis|||||20.8040|8.6325|<.0001
71887062|NCT03195517|143294597|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71887063|NCT03195517|143294598|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71887064|NCT03195517|143294599|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71887065|NCT03195517|143294600|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71716082|NCT03012334|142946960|SUPERIORITY||LS Mean|5.8||||0.0605|TWO_SIDED|95.0|-0.256|11.8317|||Mixed Models Analysis|||||11.8317|-0.2560|0.0605
71716083|NCT03012334|142946961|SUPERIORITY||LS Mean|-4.5|||<|0.001|TWO_SIDED|95.0|-6.14|-2.85|||Mixed Models Analysis|||||-2.85|-6.14|<0.001
71716084|NCT03012334|142946961|SUPERIORITY||LS Mean|-6.9|||<|0.001|TWO_SIDED|95.0|-8.58|-5.28|||Mixed Models Analysis|||||-5.28|-8.58|<0.001
71716085|NCT03012334|142946961|SUPERIORITY||LS Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-10.52|-7.23|||Mixed Models Analysis|||||-7.23|-10.52|<0.001
71716086|NCT03012334|142946961|SUPERIORITY||LS Mean|-11.2|||<|0.001|TWO_SIDED|95.0|-12.81|-9.51|||Mixed Models Analysis|||||-9.51|-12.81|<0.001
71716087|NCT03012334|142946961|SUPERIORITY||LS Mean|6.7|||<|0.001|TWO_SIDED|95.0|5.02|8.31|||Mixed Models Analysis|||||8.31|5.02|<0.001
71716088|NCT03012334|142946961|SUPERIORITY||LS Mean|4.2|||<|0.001|TWO_SIDED|95.0|2.58|5.88|||Mixed Models Analysis|||||5.88|2.58|<0.001
71716089|NCT03012334|142946961|SUPERIORITY||LS Mean|2.3|||<|0.007|TWO_SIDED|95.0|0.64|3.93|||Mixed Models Analysis|||||3.93|0.64|<0.007
71716090|NCT03012334|142946962|SUPERIORITY||LS Mean|1.439|||<|0.0001|TWO_SIDED|95.0|1.2198|1.6583|||Mixed Models Analysis|||||1.6583|1.2198|<0.0001
71716091|NCT03012334|142946962|SUPERIORITY||LS Mean|2.018|||<|0.0001|TWO_SIDED|95.0|1.7981|2.238|||Mixed Models Analysis|||||2.2380|1.7981|<0.0001
71716092|NCT03012334|142946962|SUPERIORITY||LS Mean|2.572|||<|0.0001|TWO_SIDED|95.0|2.3536|2.7909|||Mixed Models Analysis|||||2.7909|2.3536|<0.0001
71716093|NCT03012334|142946962|SUPERIORITY||LS Mean|2.553|||<|0.0001|TWO_SIDED|95.0|2.3331|2.773|||Mixed Models Analysis|||||2.7730|2.3331|<0.0001
71716094|NCT03012334|142946962|SUPERIORITY||LS Mean|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.3333|-0.8948|||Mixed Models Analysis|||||-0.8948|-1.3333|<0.0001
71716095|NCT03012334|142946962|SUPERIORITY||LS Mean|-0.535|||<|0.0001|TWO_SIDED|95.0|-0.7549|-0.3151|||Mixed Models Analysis|||||-0.3151|-0.7549|<0.0001
71716096|NCT03012334|142946962|SUPERIORITY||LS Mean|0.019||||0.8629|TWO_SIDED|95.0|-0.1995|0.2379|||Mixed Models Analysis|||||0.2379|-0.1995|0.8629
71716097|NCT03012334|142946964|SUPERIORITY||LS Mean|0.18||||0.0002|TWO_SIDED|95.0|0.0849|0.2746|||Mixed Models Analysis|||||0.2746|0.0849|0.0002
71716098|NCT03012334|142946964|SUPERIORITY||LS Mean|0.303|||<|0.0001|TWO_SIDED|95.0|0.2082|0.3985|||Mixed Models Analysis|||||0.3985|0.2082|<.0001
71828481|NCT00004124|143161502|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.8|1.27|||Regression, Cox|||||1.27|0.80|0.94
71716099|NCT03012334|142946964|SUPERIORITY||LS Mean|0.372|||<|0.0001|TWO_SIDED|95.0|0.277|0.4662|||Mixed Models Analysis|||||0.4662|0.2770|<.0001
71828482|NCT00831272|143161534|SUPERIORITY_OR_OTHER|||||||0.32|||||||Generalized Estimating Equation|||||||0.32
71828483|NCT00516386|143161535|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|543.0|STANDARD_ERROR_OF_MEAN|41.0|<|0.05|||||||Paired t-test|||We used paired t-tests to assess changes in levels of IGF-1 from baseline levels in girls with AN receiving rhIGF-1. Our hypothesis was that rhIGF-1 administration would be associated with a significant increase in IGF-1 levels.||||<0.05
71828484|NCT00516386|143161536|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.3|STANDARD_ERROR_OF_MEAN|9.3|<|0.05||95.0|||||Paired t-test|||We used a paired t-test to determine the change in P1NP from baseline to 7-10 days following administration of rhIGF-1||||<0.05
71887066|NCT03195517|143294601|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71716100|NCT03012334|142946964|SUPERIORITY||LS Mean|0.603|||<|0.0001|TWO_SIDED|95.0|0.508|0.6983|||Mixed Models Analysis|||||0.6983|0.5080|<.0001
71716101|NCT03012334|142946964|SUPERIORITY||LS Mean|-0.423|||<|0.0001|TWO_SIDED|95.0|-0.5183|-0.3286|||Mixed Models Analysis|||||-0.3286|-0.5183|<.0001
71716102|NCT03012334|142946964|SUPERIORITY||LS Mean|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.3949|-0.2047|||Mixed Models Analysis|||||-0.2047|-0.3949|<0.0001
71716103|NCT03012334|142946964|SUPERIORITY||LS Mean|-0.232|||<|0.0001|TWO_SIDED|95.0|-0.3261|-0.137|||Mixed Models Analysis|||||-0.1370|-0.3261|<0.0001
71716104|NCT02286895|142946970|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-4.0|4.2||||||Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.2|-4.0|
71716105|NCT02286895|142946971|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-12.2|4.0||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||4.0|-12.2|
71767742|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|0.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828485|NCT02694978|143161550|NON_INFERIORITY|The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.|Treatment difference|-0.1||||0.0001|TWO_SIDED|95.0|-0.8|0.61|||Wald|The p-value was calculated using the Wald large sample assumption.||"Statistical analysis was only performed on composite reaction data (that is, the Any TE moderate to severe hypersensitivity rxn row in the data table)."||0.61|-0.80|0.0001
71828486|NCT00818454|143161554|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
71887067|NCT03195517|143294602|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71887068|NCT03195517|143294603|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71887069|NCT03195517|143294604|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71887070|NCT00122135|143294667|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||||||.77
71887071|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.34|||||TWO_SIDED|90.0|66.05|149.43||||||Buprenorphine||149.43|66.05|
71716106|NCT02286895|142946972|NON_INFERIORITY|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was \> -10%.|Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-7.5|2.7||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.||2.7|-7.5|
71716107|NCT02286895|142946973|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
71716108|NCT02286895|142946974|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1|geometric mean titer ratio|-0.7|||||TWO_SIDED|95.0|-5.2|3.8||||||||3.8|-5.2|
71716109|NCT02286895|142946975|EQUIVALENCE|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||TWO_SIDED|95.0|0.7|1.3||||||||1.3|0.7|
71716110|NCT02286895|142946976|SUPERIORITY||Mean Difference (Net)|17.5|||||TWO_SIDED|95.0|9.7|25.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||25.3|9.7|
71716111|NCT02286895|142946977|SUPERIORITY||Mean Difference (Net)|15.8|||||TWO_SIDED|95.0|8.1|23.4||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.4|8.1|
71716112|NCT02286895|142946978|SUPERIORITY||Mean Difference (Net)|25.4|||||TWO_SIDED|95.0|14.6|36.2||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||36.2|14.6|
71716113|NCT02286895|142946979|SUPERIORITY||Mean Difference (Net)|31.1|||||TWO_SIDED|95.0|23.1|39.0||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||39.0|23.1|
71716114|NCT02286895|142946980|SUPERIORITY||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|12.0|23.5||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||23.5|12.0|
71716115|NCT02286895|142946981|SUPERIORITY||Mean Difference (Net)|52.0|||||TWO_SIDED|95.0|37.7|66.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.||66.3|37.7|
71767743|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.106||0.218|TWO_SIDED|95.0|-0.078|0.339||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.339|-0.078|0.218
71716116|NCT02286895|142946982|SUPERIORITY||geometric mean titer ratio|1.7|||||TWO_SIDED|95.0|1.2|2.4||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||2.4|1.2|
71716117|NCT02286895|142946983|SUPERIORITY||geometric mean titer ratio|2.3|||||TWO_SIDED|95.0|1.7|3.1||||||Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.1|1.7|
71716118|NCT02286895|142946984|SUPERIORITY||geometric mean titer ratio|2.0|||||TWO_SIDED|95.0|1.2|3.3||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||3.3|1.2|
71716119|NCT02286895|142946985|SUPERIORITY||geometric mean titer ratio|4.6|||||TWO_SIDED|95.0|2.4|8.9||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1||8.9|2.4|
71716120|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.86|1.05|||ANOVA|||Anti-HPV 6||1.05|0.86|<0.001
71716121|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
71716122|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.85|1.04|||ANOVA|||Anti-HPV 16||1.04|0.85|<0.001
71716123|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07|||ANOVA|||Anti-HPV 18||1.07|0.84|<0.001
71767744|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71716124|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANOVA|||Anti-HPV 31||1.06|0.84|<0.001
71716125|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||ANOVA|||Anti-HPV 33||1.00|0.81|<0.001
71887072|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|163.88|||||TWO_SIDED|90.0|110.82|242.34||||||Buprenorphine||242.34|110.82|
71887073|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|281.43|||||TWO_SIDED|90.0|187.1|423.33||||||Buprenorphine||423.33|187.10|
71716126|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.86|1.11|||ANOVA|||Anti-HPV 45||1.11|0.86|<0.001
71716127|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-HPV 52||1.06|0.85|<0.001
71716128|NCT01073293|142946989|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANOVA|||Anti-HPV 58||0.99|0.80|<0.001
71716129|NCT01073293|142946994|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.2|||<|0.001|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||1.4|-0.7|<0.001
71716130|NCT01073293|142946994|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||1.2|-1.1|<0.001
71716131|NCT01073293|142946995|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||ANOVA|||Anti-PT||1.06|0.85|<0.001
71828487|NCT00818454|143161555|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||MMRM ANCOVA|||||||<0.0001
71828488|NCT00818454|143161556|SUPERIORITY_OR_OTHER|||||||0.159|||||||MMRM ANCOVA|||||||0.159
71716132|NCT01073293|142946995|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.9|1.08|||ANOVA|||Anti-FHA||1.08|0.90|<0.001
71828489|NCT00818454|143161557|SUPERIORITY_OR_OTHER|||||||0.8278|||||||MMRM ANCOVA|||||||0.8278
71716133|NCT01073293|142946995|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.09|||ANOVA|||Anti-PRN||1.09|0.80|<0.001
71716134|NCT01073293|142946995|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.67|Difference in GMT|0.89||||0.005|TWO_SIDED|95.0|0.72|1.11|||ANOVA|||Anti-FIM 2/3||1.11|0.72|0.005
71716135|NCT01073293|142946996|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 1||0.8|-1.2|<0.001
71716136|NCT01073293|142946996|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 2||0.8|-1.2|<0.001
71716137|NCT01073293|142946996|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.8|||Miettinen and Nurminen|||Poliovirus type 3||0.8|-0.8|<0.001
71716138|NCT00077974|142947025|SUPERIORITY_OR_OTHER||Percent|33.0||||||95.0|24.2|42.8|||||Using exact method based on binomial distribution. Percent equals n divided by N times 100.|||42.8|24.2|
71716139|NCT00256126|142947037|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71828490|NCT00818454|143161558|SUPERIORITY_OR_OTHER|||||||0.5098|||||||MMRM ANCOVA|||||||0.5098
71887074|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.43|||||TWO_SIDED|90.0|52.14|117.98||||||Buprenorphine||117.98|52.14|
71828491|NCT00818454|143161559|SUPERIORITY_OR_OTHER|||||||0.6591|||||||MMRM ANCOVA|||||||0.6591
71828492|NCT00818454|143161560|SUPERIORITY_OR_OTHER|||||||0.3631|||||||MMRM ANCOVA|||||||0.3631
71828493|NCT00818454|143161561|NON_INFERIORITY_OR_EQUIVALENCE|Enter additional comments here, if non-inferiority or equivalence analysis||||||0.6787|||||||MMRM ANCOVA|||||||0.6787
71828494|NCT00818454|143161562|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0001
71828495|NCT00818454|143161563|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction||||||0.0003
71887075|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.66|||||TWO_SIDED|90.0|81.87|195.97||||||Buprenorphine||195.97|81.87|
71887076|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|208.94|||||TWO_SIDED|90.0|137.21|318.18||||||Buprenorphine||318.18|137.21|
71887077|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|358.83|||||TWO_SIDED|90.0|231.92|555.17||||||Buprenorphine||555.17|231.92|
71887078|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.09|||||TWO_SIDED|90.0|44.03|138.49||||||Norbuprenorphine||138.49|44.03|
71887079|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.78|||||TWO_SIDED|90.0|39.26|142.41||||||Norbuprenorphine||142.41|39.26|
71887080|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|11.45|||||TWO_SIDED|90.0|6.35|20.66||||||Norbuprenorphine||20.66|6.35|
71887081|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|71.08|||||TWO_SIDED|90.0|39.0|129.49||||||Norbuprenorphine||129.49|39.00|
71887082|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|109.9|||||TWO_SIDED|90.0|58.14|207.75||||||Norbuprenorphine||207.75|58.14|
71716140|NCT02949011|142947053|SUPERIORITY||Median Difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-42.8|-14.6||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The primary analysis of the primary endpoint was a comparison between the baloxavir marboxil and placebo groups.||-14.6|-42.8|<0.0001
71716141|NCT02949011|142947053|SUPERIORITY||Median Difference|-7.7||||0.8347|TWO_SIDED|95.0|-22.7|7.9||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The comparison between the baloxavir marboxil and the oseltamivir groups was conducted as a secondary analysis only if a statistically significant difference was observed in the primary analysis in order to maintain control of overall type I error.||7.9|-22.7|0.8347
71716142|NCT02949011|142947053|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.0008
71716143|NCT02949011|142947053|SUPERIORITY|||||||0.8449||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.8449
71716144|NCT02949011|142947054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71716145|NCT02949011|142947054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71828496|NCT02680457|143161609|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.630
71828497|NCT02680457|143161610|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71828498|NCT03823300|143161618|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.7|1.8|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||1.8|-1.7|
71828499|NCT03823300|143161619|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.4|1.3|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||1.3|-2.4|
71828500|NCT03823300|143161621|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.3|4.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||4.3|-8.3|
71828501|NCT03823300|143161621|OTHER||Difference in CMH Weighted Percentage|3.4|||||TWO_SIDED|95.0|-3.9|10.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||10.7|-3.9|
71828502|NCT03823300|143161621|OTHER||Difference in CMH Weighted Percentage|1.0|||||TWO_SIDED|95.0|-6.6|8.6|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.6|-6.6|
71828503|NCT03823300|143161621|OTHER||Difference in CMH Weighted Percentage|3.1|||||TWO_SIDED|95.0|-3.1|9.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||9.3|-3.1|
71828504|NCT03823300|143161622|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.7|5.3|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||5.3|-7.7|
71716146|NCT02949011|142947054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
71716147|NCT02949011|142947054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
71716148|NCT02949011|142947054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||<0.0001
71716149|NCT02949011|142947054|SUPERIORITY|||||||0.0044||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0044
71828505|NCT03823300|143161627|OTHER||Difference in CMH Weighted Percentage|-1.5|||||TWO_SIDED|95.0|-4.4|1.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||1.3|-4.4|
71716150|NCT02949011|142947054|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||<0.0001
71716151|NCT02949011|142947054|SUPERIORITY|||||||0.1146||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.1146
71716152|NCT02949011|142947054|SUPERIORITY|||||||0.0046||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0046
71716153|NCT02949011|142947054|SUPERIORITY|||||||0.441||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.441
71716154|NCT02949011|142947054|SUPERIORITY|||||||0.0929||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0929
71716155|NCT02949011|142947054|SUPERIORITY|||||||0.0907||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0907
71828506|NCT03823300|143161627|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-4.5|2.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||2.8|-4.5|
71828507|NCT03823300|143161627|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-2.1|7.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||7.3|-2.1|
71828508|NCT03823300|143161628|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.3|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.3|-2.6|
71828509|NCT03823300|143161632|OTHER||Difference in CMH Weighted Percentage|-1.7|||||TWO_SIDED|95.0|-8.5|5.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||5.1|-8.5|
71828510|NCT03823300|143161634|OTHER||Difference in CMH Weighted Percentage|5.7|||||TWO_SIDED|95.0|-1.4|12.9|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||12.9|-1.4|
71828511|NCT03823300|143161636|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-3.6|4.4|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||4.4|-3.6|
71887083|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.23|||||TWO_SIDED|90.0|52.17|212.24||||||Norbuprenorphine||212.24|52.17|
71716156|NCT02949011|142947055|SUPERIORITY|||||||0.7383||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.7383
71716157|NCT02949011|142947055|SUPERIORITY|||||||0.9619||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||0.9619
71716158|NCT02949011|142947055|SUPERIORITY|||||||0.0576||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0576
71716159|NCT02949011|142947055|SUPERIORITY|||||||0.1237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.1237
71716160|NCT02949011|142947055|SUPERIORITY|||||||0.3071||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.3071
71828512|NCT03823300|143161644|OTHER||Adjusted mean difference|-6.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.8|2.1|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||2.1|-14.8|
71716161|NCT02949011|142947055|SUPERIORITY|||||||0.9603||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9603
71716162|NCT02949011|142947055|SUPERIORITY|||||||0.0784||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0784
71716163|NCT02949011|142947055|SUPERIORITY|||||||0.5547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5547
71887084|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|16.12|||||TWO_SIDED|90.0|8.4|30.94||||||Norbuprenorphine||30.94|8.40|
71716164|NCT02949011|142947055|SUPERIORITY|||||||0.3087||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.3087
71716165|NCT02949011|142947055|SUPERIORITY|||||||0.9106||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9106
71716166|NCT02949011|142947055|SUPERIORITY|||||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0017
71716167|NCT02949011|142947055|SUPERIORITY|||||||0.3068||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.3068
71716168|NCT02949011|142947056|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71716169|NCT02949011|142947056|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71767745|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.799|TWO_SIDED|95.0|-0.219|0.169||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.169|-0.219|0.799
71767746|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71828513|NCT03823300|143161645|OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|4.05|||TWO_SIDED|95.0|-6.6|9.3|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.3|-6.6|
71828514|NCT01678196|143161661|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||Chi-squared|||||||0.927
71828515|NCT01678196|143161662|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.||||||0.67
71828516|NCT01678196|143161663|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time||||||0.743
71828517|NCT01678196|143161664|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)||||||<.001
71887085|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.3|||||TWO_SIDED|90.0|40.03|157.12||||||Naloxone||157.12|40.03|
71716170|NCT02949011|142947056|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
71716171|NCT02949011|142947056|SUPERIORITY|||||||0.0024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0024
71716172|NCT02949011|142947056|SUPERIORITY|||||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ven Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.9127
71716173|NCT02949011|142947056|SUPERIORITY|||||||0.5361||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.5361
71716174|NCT02949011|142947056|SUPERIORITY|||||||0.5739||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5739
71716175|NCT02949011|142947056|SUPERIORITY|||||||0.5466||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5466
71716176|NCT02949011|142947056|SUPERIORITY|||||||0.0543||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.0543
71828518|NCT03987451|143161685|SUPERIORITY||Odds Ratio (OR)|0.28||||0.0867|TWO_SIDED|95.0|0.06|1.24|||Cochran-Mantel-Haenszel|||The common odds ratio between semaglutide and placebo adjusting for baseline diabetes was estimated along with exact 95% confidence interval based on conditioning on the marginal 2×2 tables.||1.24|0.06|0.0867
71828519|NCT01194154|143161760|SUPERIORITY_OR_OTHER||treatment effect|2.21||||0.657|TWO_SIDED|95.0|-0.35|4.78|||Wilcoxon (Mann-Whitney)||An analysis of covariance (ANCOVA) model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||4.78|-0.35|0.657
71828520|NCT01194154|143161761|SUPERIORITY_OR_OTHER||treatment effect|2.24||||0.709|TWO_SIDED|95.0|-0.54|5.01|||Wilcoxon (Mann-Whitney)||ANCOVA model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.|||5.01|-0.54|0.709
71887086|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|317.58|||||TWO_SIDED|90.0|164.93|611.54||||||Naloxone||611.54|164.93|
71887087|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1401.85|||||TWO_SIDED|90.0|707.55|2777.46||||||Naloxone||2777.46|707.55|
71887088|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|105.78|||||TWO_SIDED|90.0|53.39|209.59||||||Naloxone||209.59|53.39|
71767747|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.098||0.406|TWO_SIDED|95.0|-0.273|0.111||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.111|-0.273|0.406
71767748|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767749|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.099||0.363|TWO_SIDED|95.0|-0.285|0.105||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.105|-0.285|0.363
71767750|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767751|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.125||0.22|TWO_SIDED|95.0|-0.4|0.093||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.093|-0.400|0.220
71767752|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767753|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.123||0.245|TWO_SIDED|95.0|-0.386|0.099||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.099|-0.386|0.245
71767754|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767755|NCT02880956|143037259|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.127||0.569|TWO_SIDED|95.0|-0.323|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.178|-0.323|0.569
71767756|NCT02880956|143037259|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767757|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.093||0.945|TWO_SIDED|95.0|-0.177|0.19||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.190|-0.177|0.945
71767758|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767759|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.092||0.974|TWO_SIDED|95.0|-0.184|0.178||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.178|-0.184|0.974
71767760|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767761|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.094||0.963|TWO_SIDED|95.0|-0.19|0.181||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||||0.181|-0.190|0.963
71767762|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767763|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.104||0.625|TWO_SIDED|95.0|-0.255|0.154||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.154|-0.255|0.625
71767764|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767765|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.468|TWO_SIDED|95.0|-0.272|0.125||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.125|-0.272|0.468
71767766|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767767|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.104||0.636|TWO_SIDED|95.0|-0.155|0.254||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.254|-0.155|0.636
71767768|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828521|NCT02314117|143161767|SUPERIORITY||Hazard Ratio (HR)|0.753|||||TWO_SIDED|95.0|0.607|0.935||||||||0.935|0.607|
71828522|NCT02314117|143161768|SUPERIORITY||Hazard Ratio (HR)|0.962|||||TWO_SIDED|95.0|0.801|1.156||||||||1.156|0.801|
71716177|NCT02949011|142947056|SUPERIORITY|||||||0.4677||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.4677
71716178|NCT02949011|142947056|SUPERIORITY|||||||0.0266||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.0266
71716179|NCT02949011|142947056|SUPERIORITY|||||||0.1281||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.1281
71716180|NCT02949011|142947057|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71716181|NCT02949011|142947057|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2||||<0.0001
71716182|NCT02949011|142947057|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||<0.0001
71716183|NCT02949011|142947057|SUPERIORITY|||||||0.0015||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3||||0.0015
71716184|NCT02949011|142947057|SUPERIORITY|||||||0.0028||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0028
71828523|NCT02314117|143161769|SUPERIORITY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.774|1.108||||||||1.108|0.774|
71828524|NCT02314117|143161772|SUPERIORITY||Hazard Ratio (HR)|0.699|||||TWO_SIDED|95.0|0.569|0.859||||||||0.859|0.569|
71716185|NCT02949011|142947057|SUPERIORITY|||||||0.0265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4||||0.0265
71716186|NCT02949011|142947057|SUPERIORITY|||||||0.0247||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.0247
71716187|NCT02949011|142947057|SUPERIORITY|||||||0.5298||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5||||0.5298
71716188|NCT02949011|142947057|SUPERIORITY|||||||0.9554||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9554
71716189|NCT02949011|142947057|SUPERIORITY|||||||0.9075||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6||||0.9075
71716190|NCT02949011|142947057|SUPERIORITY|||||||0.7624||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.7624
71716191|NCT02949011|142947057|SUPERIORITY|||||||0.6156||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9||||0.6156
71716192|NCT02949011|142947058|SUPERIORITY|||||||0.034||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0340
71716193|NCT02949011|142947058|SUPERIORITY|||||||0.2766||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.2766
71716194|NCT02949011|142947059|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0072
71716195|NCT02949011|142947059|SUPERIORITY|||||||0.733||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.7330
71716196|NCT02949011|142947060|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-48.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-48.0|-48.0|<0.0001
71828525|NCT02314117|143161773|SUPERIORITY||Hazard Ratio (HR)|0.657|||||TWO_SIDED|95.0|0.499|0.866||||||||0.866|0.499|
71828526|NCT02314117|143161774|SUPERIORITY||Hazard Ratio (HR)|1.013|||||TWO_SIDED|95.0|0.77|1.332||||||||1.332|0.770|
71828527|NCT02314117|143161776|SUPERIORITY||Hazard Ratio (HR)|1.117|||||TWO_SIDED|95.0|0.79|1.58||||||||1.580|0.790|
71887089|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|74.97|||||TWO_SIDED|90.0|36.09|155.71||||||Naloxone||155.71|36.09|
71887090|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|300.22|||||TWO_SIDED|90.0|148.44|607.21||||||Naloxone||607.21|148.44|
71828528|NCT02026258|143161780|OTHER||Mean Difference (Final Values)|0.52|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.||||<0.05
71828529|NCT02026258|143161781|OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T0||||<0.05
71828530|NCT02026258|143161781|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T1||||<0.05
71716197|NCT02949011|142947060|SUPERIORITY||Median Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-48.0|-24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||-24.0|-48.0|<0.0001
71716198|NCT02949011|142947061|SUPERIORITY||Median Difference|-24.0||||0.0006|TWO_SIDED|95.0|-96.0|0.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||0.0|-96.0|0.0006
71716199|NCT02949011|142947061|SUPERIORITY||Median Difference|0.0||||0.237|TWO_SIDED|95.0|-48.0|24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region||||24.0|-48.0|0.2370
71716200|NCT02949011|142947062|SUPERIORITY|||||||0.7698||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.7698
71716201|NCT02949011|142947062|SUPERIORITY|||||||0.5777||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.5777
71716202|NCT02949011|142947062|SUPERIORITY|||||||0.1112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.1112
71716203|NCT02949011|142947062|SUPERIORITY|||||||0.6483||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.6483
71716204|NCT02949011|142947062|SUPERIORITY|||||||0.0004||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.0004
71716205|NCT02949011|142947062|SUPERIORITY|||||||0.5625||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.5625
71716206|NCT02949011|142947062|SUPERIORITY|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.0072
71716207|NCT02949011|142947062|SUPERIORITY|||||||0.6234||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.6234
71828531|NCT02026258|143161781|OTHER||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T2||||<0.05
71828532|NCT02026258|143161781|OTHER||Mean Difference (Final Values)|0.76|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS T3||||<0.05
71828533|NCT02026258|143161782|OTHER||Mean Difference (Final Values)|0.87|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ease of Procedure||||<0.05
71828534|NCT02026258|143161782|OTHER||Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Satisfaction with procedure||||<0.05
71716208|NCT02949011|142947062|SUPERIORITY|||||||0.0002||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0002
71716209|NCT02949011|142947062|SUPERIORITY|||||||0.9547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.9547
71716210|NCT02949011|142947062|SUPERIORITY|||||||0.0012||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0012
71716211|NCT02949011|142947062|SUPERIORITY|||||||0.186||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.1860
71828535|NCT02026258|143161783|OTHER||Fisher chi square|0.71|||<|0.05|TWO_SIDED||||||Fisher Exact|Use of Medications||||||<0.05
71828536|NCT02026258|143161783|OTHER||Fisher chi square|0.99|||<|0.05|TWO_SIDED||||||Fisher Exact|||Undergo procedure again||||<0.05
71828537|NCT02026258|143161783|OTHER||Fisher chi square|0.49|||<|0.05|TWO_SIDED||||||Fisher Exact|||Recommend procedure to a friend||||<0.05
71828538|NCT02534350|143161784|SUPERIORITY||Treatment Difference|0.1||||0.72|TWO_SIDED|95.0|-0.43|0.63|||ANCOVA|||||0.63|-0.43|0.72
71828539|NCT02534350|143161785|SUPERIORITY||Treatment Difference|-0.12||||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
71828540|NCT02534350|143161786|SUPERIORITY||Treatment Difference|0.01||||0.86|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.86
71716212|NCT02949011|142947062|SUPERIORITY|||||||0.0274||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.0274
71716213|NCT02949011|142947062|SUPERIORITY|||||||0.9635||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.9635
71716214|NCT02949011|142947062|SUPERIORITY|||||||0.0081||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.0081
71716215|NCT02949011|142947062|SUPERIORITY|||||||0.7425||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.7425
71716216|NCT02949011|142947062|SUPERIORITY|||||||0.0209||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.0209
71716217|NCT02949011|142947062|SUPERIORITY|||||||0.7448||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7448
71716218|NCT02949011|142947062|SUPERIORITY|||||||0.0644||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.0644
71716219|NCT02949011|142947062|SUPERIORITY|||||||0.4931||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4931
71716220|NCT02949011|142947062|SUPERIORITY|||||||0.0708||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.0708
71716221|NCT02949011|142947062|SUPERIORITY|||||||0.4024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.4024
71716222|NCT02949011|142947063|SUPERIORITY||Median Difference|-25.8|||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||<0.0001
71716223|NCT02949011|142947063|SUPERIORITY||Median Difference|-8.6||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9127
71716224|NCT02949011|142947064|SUPERIORITY||Median Difference|-15.1||||0.0013||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0013
71716225|NCT02949011|142947064|SUPERIORITY||Median Difference|2.3||||0.8498||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.8498
71716226|NCT02949011|142947065|SUPERIORITY||Median Difference|-24.1||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.0001
71767769|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.112||0.887|TWO_SIDED|95.0|-0.204|0.236||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.236|-0.204|0.887
71767770|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.84|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71716227|NCT02949011|142947065|SUPERIORITY||Median Difference|1.5||||0.9237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.9237
71716228|NCT02949011|142947066|SUPERIORITY||Median Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-28.8|-12.5||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||-12.5|-28.8|<0.0001
71716229|NCT02949011|142947066|SUPERIORITY||Median Difference|-3.5||||0.2425|TWO_SIDED|95.0|-9.1|2.7||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||2.7|-9.1|0.2425
71716230|NCT02949011|142947067|SUPERIORITY|||||||0.1713||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.1713
71716231|NCT02949011|142947067|SUPERIORITY|||||||0.2249||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours||||0.2249
71716232|NCT02949011|142947067|SUPERIORITY|||||||0.0387||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.0387
71716233|NCT02949011|142947067|SUPERIORITY|||||||0.3915||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours||||0.3915
71716234|NCT02949011|142947067|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||<0.0001
71716235|NCT02949011|142947067|SUPERIORITY|||||||0.2617||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours||||0.2617
71716236|NCT02949011|142947067|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||<0.0001
71716237|NCT02949011|142947067|SUPERIORITY|||||||0.8808||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours||||0.8808
71716238|NCT02949011|142947067|SUPERIORITY|||||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.0001
71716239|NCT02949011|142947067|SUPERIORITY|||||||0.5923||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours||||0.5923
71716240|NCT02949011|142947067|SUPERIORITY|||||||0.0064||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.0064
71716241|NCT02949011|142947067|SUPERIORITY|||||||0.6746||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours||||0.6746
71828541|NCT02534350|143161787|SUPERIORITY||Treatment Difference|-3.25||||0.6|TWO_SIDED|95.0|-15.58|9.08|||ANCOVA|||||9.08|-15.58|0.60
71828542|NCT04673851|143161788|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.86|STANDARD_DEVIATION|5.44|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71716242|NCT02949011|142947067|SUPERIORITY|||||||0.8167||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.8167
71716243|NCT02949011|142947067|SUPERIORITY|||||||0.3773||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours||||0.3773
71716244|NCT02949011|142947067|SUPERIORITY|||||||0.1041||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.1041
71828543|NCT04673851|143161788|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.16|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71828544|NCT04673851|143161788|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.65|STANDARD_DEVIATION|5.61|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71716245|NCT02949011|142947067|SUPERIORITY|||||||0.3328||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours||||0.3328
71716246|NCT02949011|142947067|SUPERIORITY|||||||0.7867||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.7867
71716247|NCT02949011|142947067|SUPERIORITY|||||||0.864||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours||||0.8640
71716248|NCT02949011|142947067|SUPERIORITY|||||||0.6465||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.6465
71716249|NCT02949011|142947067|SUPERIORITY|||||||0.4265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours||||0.4265
71716250|NCT02949011|142947067|SUPERIORITY|||||||0.6568||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6568
71828545|NCT04673851|143161788|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.47|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71828546|NCT04673851|143161788|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.97|STANDARD_DEVIATION|7.19|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71716251|NCT02949011|142947067|SUPERIORITY|||||||0.6102||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours||||0.6102
71716252|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.0408|TWO_SIDED|95.0|-0.28|-0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||-0.01|-0.28|0.0408
71716253|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5324|TWO_SIDED|95.0|-0.18|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours||0.09|-0.18|0.5324
71767771|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.111||0.016|TWO_SIDED|95.0|0.051|0.486||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.486|0.051|0.016
71767772|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.33|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767773|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.112||0.272|TWO_SIDED|95.0|-0.097|0.342||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.342|-0.097|0.272
71828547|NCT04673851|143161788|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71828548|NCT04673851|143161788|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-4.15|STANDARD_DEVIATION|7.93|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71828549|NCT04673851|143161788|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.52|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71828550|NCT04673851|143161789|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-1.52|STANDARD_DEVIATION|8.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71828551|NCT04673851|143161789|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71887091|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1325.22|||||TWO_SIDED|90.0|638.03|2752.55||||||Naloxone||2752.55|638.03|
71716254|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.3|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||-0.06|-0.30|0.0025
71716255|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.4874|TWO_SIDED|95.0|-0.08|0.16||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours||0.16|-0.08|0.4874
71716256|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||-0.24|-0.47|<0.0001
71716257|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5414|TWO_SIDED|95.0|-0.15|0.08||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours||0.08|-0.15|0.5414
71716258|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.44|-0.22||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||-0.22|-0.44|<0.0001
71716259|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3185|TWO_SIDED|95.0|-0.17|0.05||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours||0.05|-0.17|0.3185
71767774|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71828552|NCT04673851|143161789|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|1.15|STANDARD_DEVIATION|5.8|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71828553|NCT04673851|143161789|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.2|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71887092|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|85.87|||||TWO_SIDED|90.0|66.06|111.61||||||Naloxone-3-β-D-Glucuronide||111.61|66.06|
71887093|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|123.77|||||TWO_SIDED|90.0|96.27|159.13||||||Naloxone-3-β-D-Glucuronide||159.13|96.27|
71887094|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|91.26|||||TWO_SIDED|90.0|70.21|118.62||||||Naloxone-3-β-D-Glucuronide||118.62|70.21|
71716260|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0025|TWO_SIDED|95.0|-0.26|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||-0.06|-0.26|0.0025
71716261|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8299|TWO_SIDED|95.0|-0.09|0.11||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours||0.11|-0.09|0.8299
71716262|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.0878|TWO_SIDED|95.0|-0.19|0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.01|-0.19|0.0878
71716263|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7498|TWO_SIDED|95.0|-0.09|0.12||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours||0.12|-0.09|0.7498
71716264|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.803|TWO_SIDED|95.0|-0.11|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.09|-0.11|0.8030
71716265|NCT02949011|142947068|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3577|TWO_SIDED|95.0|-0.05|0.15||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours||0.15|-0.05|0.3577
71716266|NCT02949011|142947069|SUPERIORITY||Median Difference|-23.1||||0.0009||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.0009
71716267|NCT02949011|142947069|SUPERIORITY||Median Difference|-0.2||||0.4074||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough||||0.4074
71716268|NCT02949011|142947069|SUPERIORITY||Median Difference|-6.3||||0.2496||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2496
71716269|NCT02949011|142947069|SUPERIORITY||Median Difference|0.9||||0.2963||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat||||0.2963
71767775|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.145||0.671|TWO_SIDED|95.0|-0.223|0.347||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.347|-0.223|0.671
71767776|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767777|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.143||0.493|TWO_SIDED|95.0|-0.183|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.378|-0.183|0.493
71767778|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767779|NCT02880956|143037260|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.147||0.501|TWO_SIDED|95.0|-0.19|0.387||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.387|-0.190|0.501
71716270|NCT02949011|142947069|SUPERIORITY||Median Difference|-10.6||||0.039||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.0390
71716271|NCT02949011|142947069|SUPERIORITY||Median Difference|2.0||||0.7877||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache||||0.7877
71716272|NCT02949011|142947069|SUPERIORITY||Median Difference|-12.1||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.0017
71767780|NCT02880956|143037260|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767781|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.188||0.742|TWO_SIDED|95.0|-0.307|0.431||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.431|-0.307|0.742
71716273|NCT02949011|142947069|SUPERIORITY||Median Difference|1.5||||0.8119||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion||||0.8119
71716274|NCT02949011|142947069|SUPERIORITY||Median Difference|-3.6||||0.007||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.0070
71716275|NCT02949011|142947069|SUPERIORITY||Median Difference|-0.7||||0.9191||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills||||0.9191
71716276|NCT02949011|142947069|SUPERIORITY||Median Difference|-7.7||||0.0232||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.0232
71716277|NCT02949011|142947069|SUPERIORITY||Median Difference|4.0||||0.5436||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain||||0.5436
71716278|NCT02949011|142947069|SUPERIORITY||Median Difference|-7.5||||0.0207||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.0207
71716279|NCT02949011|142947069|SUPERIORITY||Median Difference|-1.9||||0.371||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue||||0.3710
71716280|NCT02949011|142947070|SUPERIORITY||Median Difference|-23.4||||0.4634||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.4634
71828554|NCT04673851|143161789|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.67|STANDARD_DEVIATION|10.29|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71716281|NCT02949011|142947070|SUPERIORITY||Median Difference|-0.6||||0.6386||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice's generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||||||0.6386
71716282|NCT02949011|142947071|SUPERIORITY|||||||0.0112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.0112
71716283|NCT02949011|142947071|SUPERIORITY|||||||0.8478||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||||||0.8478
71767782|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767783|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.185||0.431|TWO_SIDED|95.0|-0.511|0.218||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.218|-0.511|0.431
71767784|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767785|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.29|TWO_SIDED|95.0|-0.574|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.574|0.290
71767786|NCT02880956|143037261|SUPERIORITY||effect size|0.13|STANDARD_DEVIATION|1.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767787|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.191||0.541|TWO_SIDED|95.0|-0.492|0.258||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.258|-0.492|0.541
71767788|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767789|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.186||0.617|TWO_SIDED|95.0|-0.459|0.272||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.272|-0.459|0.617
71767790|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767791|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.457|TWO_SIDED|95.0|-0.517|0.233||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.233|-0.517|0.457
71716284|NCT02949011|142947072|SUPERIORITY||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||<0.0001
71716285|NCT02949011|142947072|SUPERIORITY|||||||0.2558||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2558
71716286|NCT00163189|142947074|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Student's paired t-test|||Month 36||||<0.001
71716287|NCT00163189|142947075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Student's paired t-test|||Month 36||||0.008
71716288|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.21||||0.92|TWO_SIDED|95.0|-4.48|4.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for FACT-B 3 month Total Score||4.05|-4.48|0.92
71716289|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|1.37||||0.57|TWO_SIDED|95.0|-3.41|6.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for FACT-B 6 month Total Score||6.15|-3.41|0.57
71716290|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|1.18||||0.62|TWO_SIDED|95.0|-3.54|5.89|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the Fact-B 12 month Total Score||5.89|-3.54|0.62
71716291|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|0.12||||0.83|TWO_SIDED|95.0|-0.99|1.23|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Physical Well-Being Subscale||1.23|-0.99|0.83
71716292|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.15||||0.82|TWO_SIDED|95.0|-1.15|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 6 month Physical Well-Being Subscale||1.45|-1.15|0.82
71716293|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.84|TWO_SIDED|95.0|-1.41|1.15|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||Data below is for the Fact-B 12 month Physical Well-Being Subscale||1.15|-1.41|0.84
71716294|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.77|TWO_SIDED|95.0|-1.31|0.96|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Social/Family Well-Being Subscale||0.96|-1.31|0.77
71716295|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.56||||0.42|TWO_SIDED|95.0|-1.91|0.79|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Social/Family Well-Being Subscale||0.79|-1.91|0.42
71716296|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.08||||0.9|TWO_SIDED|95.0|-1.41|1.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Social/Family Well-Being Subscale||1.24|-1.41|0.90
71716297|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.9|TWO_SIDED|95.0|-0.76|0.87|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Emotional Well-Being Subscale||0.87|-0.76|0.90
71716298|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.58||||0.25|TWO_SIDED|95.0|-0.4|1.56|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact B 6 month Emotional Well-Being Subscale||1.56|-0.40|0.25
71716299|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.22|TWO_SIDED|95.0|-0.36|1.57|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Emotional Well-Being Subscale||1.57|-0.36|0.22
71767792|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.5|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828555|NCT04673851|143161789|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.07|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71656768|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.15|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.04|-0.15|
71656769|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.19|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.03|-0.19|
71656770|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.12|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.09|-0.12|
71656771|NCT00444457|142831446|NON_INFERIORITY_OR_EQUIVALENCE|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.05|0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.17|-0.05|
71656772|NCT00444457|142831447|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.1|||||TWO_SIDED|95.0|-3.3|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-3.3|
71656773|NCT00444457|142831448|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-2.1|
71656774|NCT00444457|142831448|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.6|||||TWO_SIDED|95.0|-3.4|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.0|-3.4|
71656775|NCT00444457|142831448|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.5|||||TWO_SIDED|95.0|-1.5|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||3.0|-1.5|
71656776|NCT00444457|142831449|NON_INFERIORITY_OR_EQUIVALENCE|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.4|2.2|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.||2.2|-2.4|
71656777|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.0|||||TWO_SIDED|95.0|-0.51|4.75||||||Common serotypes - serotype 4||4.75|-0.51|
71656778|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.09|1.1||||||Common serotypes - serotype 4||1.10|-3.09|
71656779|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.9|||||TWO_SIDED|95.0|-5.58|-0.58||||||Common serotypes - serotype 4||-0.58|-5.58|
71656780|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|5.3|||||TWO_SIDED|95.0|1.55|9.19||||||Common serotypes - serotype 6B||9.19|1.55|
71656781|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.4|||||TWO_SIDED|95.0|-2.77|3.66||||||Common serotypes - serotype 6B||3.66|-2.77|
71656782|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.9|||||TWO_SIDED|95.0|-8.82|-1.1||||||Common serotypes - serotype 6B||-1.10|-8.82|
71767793|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|0.22|STANDARD_ERROR_OF_MEAN|0.188||0.245|TWO_SIDED|95.0|-0.151|0.59||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.590|-0.151|0.245
71767794|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71716300|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.14||||0.81|TWO_SIDED|95.0|-1.05|1.34|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 3 month Functional Well-Being Subscale||1.34|-1.05|0.81
71716301|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.54||||0.45|TWO_SIDED|95.0|-0.85|1.94|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for Fact-B 6 month Functional Well-Being Subscale||1.94|-0.85|0.45
71716302|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.11||||0.87|TWO_SIDED|95.0|-1.48|1.26|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Functional Well-Being Subscale||1.26|-1.48|0.87
71716303|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.16||||0.8|TWO_SIDED|95.0|-1.13|1.45|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 3 month Breast Cancer Subscale||1.45|-1.13|0.80
71716304|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.73||||0.35|TWO_SIDED|95.0|-0.79|2.24|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 6 month Breast Cancer Subscale||2.24|-0.79|0.35
71716305|NCT02941614|142947131|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.6||||0.42|TWO_SIDED|95.0|-0.88|2.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects.||The data below is for the Fact-B 12 month Breast Cancer Subscale||2.09|-0.88|0.42
71767795|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.187||0.491|TWO_SIDED|95.0|-0.238|0.496||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.496|-0.238|0.491
71767796|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767797|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.188||0.132|TWO_SIDED|95.0|-0.085|0.652||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.652|-0.085|0.132
71767798|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767799|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.19||0.751|TWO_SIDED|95.0|-0.434|0.313||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.313|-0.434|0.751
71767800|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767801|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.188||0.157|TWO_SIDED|95.0|-0.635|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.103|-0.635|0.157
71767802|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|1.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767803|NCT02880956|143037261|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.192||0.283|TWO_SIDED|95.0|-0.585|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.172|-0.585|0.283
71767804|NCT02880956|143037261|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828556|NCT04673851|143161789|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.07|STANDARD_DEVIATION|9.47|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71716306|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction.|see above|-0.03||||0.59|TWO_SIDED|95.0|-0.15|0.09||We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects|Mixed Models Analysis|||Data below is for the BCPT survey 3 month Total Score.||0.09|-0.15|0.59
71716307|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.05||||0.47|TWO_SIDED|95.0|-0.09|0.19|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Total Score||0.19|-0.09|0.47
71716308|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.37|TWO_SIDED|95.0|-0.2|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Total Score||0.07|-0.20|0.37
71716309|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.05||||0.65|TWO_SIDED|95.0|-0.26|0.17|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Hot Flashes Sub-Scale||0.17|-0.26|0.65
71716310|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.08||||0.54|TWO_SIDED|95.0|-0.17|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Hot Flashes Sub-Scale||0.33|-0.17|0.54
71716311|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.02||||0.87|TWO_SIDED|95.0|-0.27|0.22|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Hot Flashes Sub-Scale||0.22|-0.27|0.87
71716312|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.06||||0.32|TWO_SIDED|95.0|-0.17|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Nausea Sub-Scale||0.06|-0.17|0.32
71716313|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.0||||0.96|TWO_SIDED|95.0|-0.15|0.14|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Nausea Sub-Scale||0.14|-0.15|0.96
71716314|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Nausea Sub-Scale||0.07|-0.21|0.32
71716315|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.44|TWO_SIDED|95.0|-0.24|0.11|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Bladder Control Sub-Scale||0.11|-0.24|0.44
71716316|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.38|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Bladder Control Sub-Scale||0.30|-0.11|0.38
71767805|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.363|TWO_SIDED|95.0|-0.085|0.231||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.231|-0.085|0.363
71767806|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828557|NCT04673851|143161789|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.22|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71716317|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.07||||0.47|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is for the BCPT survey 12 month Bladder Control Sub-Scale||0.13|-0.28|0.47
71828558|NCT04673851|143161790|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.05|STANDARD_DEVIATION|7.08|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71716318|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.17||||0.13|TWO_SIDED|95.0|-0.39|0.05|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Vaginal Problems Sub-Scale||0.05|-0.39|0.13
71716319|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.29||||0.03|TWO_SIDED|95.0|-0.55|-0.02|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Vaginal Problems Sub-Scale||-0.02|-0.55|0.03
71716320|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.19||||0.14|TWO_SIDED|95.0|-0.45|0.06|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Vaginal Problems Sub-Scale||0.06|-0.45|0.14
71716321|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.53|TWO_SIDED|95.0|-0.14|0.28|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Musculoskeletal Pain Sub-Scale||0.28|-0.14|0.53
71716322|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.47|TWO_SIDED|95.0|-0.16|0.35|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Musculoskeletal Pain Sub-Scale||0.35|-0.16|0.47
71716323|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.07||||0.57|TWO_SIDED|95.0|-0.18|0.33|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Musculoskeletal Pain Sub-Scale||0.33|-0.18|0.57
71716324|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.21|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Cognitive Problems Sub-Scale||0.21|-0.18|0.85
71716325|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.1||||0.38|TWO_SIDED|95.0|-0.12|0.32|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Cognitive Problems Sub-Scale||0.32|-0.12|0.38
71716326|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.13||||0.23|TWO_SIDED|95.0|-0.35|0.09|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Cognitive Problems Sub-Scale||0.09|-0.35|0.23
71716327|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.14||||0.18|TWO_SIDED|95.0|-0.35|0.07|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Weight Problems Sub-Scale||0.07|-0.35|0.18
71716328|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.35|TWO_SIDED|95.0|-0.36|0.13|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Weight Problems Sub-Scale||0.13|-0.36|0.35
71716329|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|-0.12||||0.34|TWO_SIDED|95.0|-0.36|0.12|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Weight Problems Sub-Scale||0.12|-0.36|0.34
71828559|NCT04673851|143161790|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.01|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71828560|NCT04673851|143161790|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.35|STANDARD_DEVIATION|7.53|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71828561|NCT04673851|143161790|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.31|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71828562|NCT04673851|143161790|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|9.95|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71767807|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.079||0.688|TWO_SIDED|95.0|-0.188|0.124||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.124|-0.188|0.688
71767808|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767809|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.081||0.137|TWO_SIDED|95.0|-0.039|0.281||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.281|-0.039|0.137
71767810|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767811|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.107||0.408|TWO_SIDED|95.0|-0.3|0.122||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.122|-0.300|0.408
71767812|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767813|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.104||0.249|TWO_SIDED|95.0|-0.325|0.085||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.085|-0.325|0.249
71767814|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828563|NCT04673851|143161790|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71767815|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.616|TWO_SIDED|95.0|-0.265|0.157||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.157|-0.265|0.616
71828564|NCT04673851|143161790|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|-2.56|STANDARD_DEVIATION|9.6|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71767816|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767817|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.119||0.555|TWO_SIDED|95.0|-0.163|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.304|-0.163|0.555
71767818|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767819|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.117||0.815|TWO_SIDED|95.0|-0.203|0.258||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.258|-0.203|0.815
71767820|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767821|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.119||0.138|TWO_SIDED|95.0|-0.057|0.409||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.409|-0.057|0.138
71767822|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767823|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.157||0.573|TWO_SIDED|95.0|-0.397|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.220|-0.397|0.573
71767824|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767825|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.154||0.689|TWO_SIDED|95.0|-0.241|0.365||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.365|-0.241|0.689
71767826|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828565|NCT04673851|143161790|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.27|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71767827|NCT02880956|143037262|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.159||0.662|TWO_SIDED|95.0|-0.243|0.382||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.382|-0.243|0.662
71767828|NCT02880956|143037262|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767829|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.184||0.291|TWO_SIDED|95.0|-0.555|0.167||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.167|-0.555|0.291
71767830|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767831|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|-0.36|STANDARD_ERROR_OF_MEAN|0.182||0.051|TWO_SIDED|95.0|-0.713|0.001||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.001|-0.713|0.051
71767832|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|1.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71716330|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.22|TWO_SIDED|95.0|-0.06|0.25|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 3 month Arm Problems Sub-Scale||0.25|-0.06|0.22
71716331|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.11||||0.26|TWO_SIDED|95.0|-0.08|0.29|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 6 month Arm Problems Sub-Scale||0.29|-0.08|0.26
71716332|NCT02941614|142947132|OTHER|Conducted test of null hypothesis of no difference vs any, between intervention and control sites at three different time periods (6- vs. 3-months, 12- vs. 6-months, 12- vs. 3-months), as well as omnibus test of treatment-by-time interaction|see above|0.09||||0.34|TWO_SIDED|95.0|-0.09|0.27|||Mixed Models Analysis|We used a difference-in-differences model to estimate the time, treatment, and time-by-treatment effects||The data below is the BCPT survey 12 month Arm Problems Sub-Scale||0.27|-0.09|0.34
71716333|NCT02941614|142947133|OTHER||Rate Ratio|0.86||||0.006|TWO_SIDED|95.0|0.77|0.96|||Regression, Poisson|||||0.96|0.77|0.006
71767833|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.185||0.921|TWO_SIDED|95.0|-0.346|0.383||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.383|-0.346|0.921
71767834|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767835|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.211||0.163|TWO_SIDED|95.0|-0.711|0.12||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.120|-0.711|0.163
71767836|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828566|NCT04673851|143161791|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|8.27|||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71828567|NCT04673851|143161791|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.04|||||TWO_SIDED|||||||||Midtreatment - Baseline: 21 participants analyzed (had data at both timepoints)||||
71716334|NCT02941614|142947134|OTHER||Rate Ratio|1.07||||0.356|TWO_SIDED|95.0|0.93|1.07|||Regression, Poisson|||||1.07|0.93|0.356
71716335|NCT02941614|142947135|OTHER||Rate Ratio|1.02||||0.919|TWO_SIDED|95.0|0.73|1.41|||Regression/Poisson|||||1.41|0.73|0.919
71716336|NCT02941614|142947136|OTHER||Rate Ratio|1.16||||0.367|TWO_SIDED|95.0|0.84|1.62|||Regression, Poisson|||The data below applies to Emergency Department visits||1.62|0.84|0.367
71767837|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.205||0.424|TWO_SIDED|95.0|-0.567|0.239||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.239|-0.567|0.424
71767838|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828568|NCT04673851|143161791|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|2.6|STANDARD_DEVIATION|7.86|||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71828569|NCT04673851|143161791|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - Baseline: 20 participants analyzed (had data at both timepoints)||||
71887095|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.78|||||TWO_SIDED|90.0|65.23|110.2||||||Naloxone-3-β-D-Glucuronide||110.20|65.23|
71716337|NCT02941614|142947136|OTHER||Rate Ratio|0.84||||0.497|TWO_SIDED|95.0|0.51|1.38|||Regression, Poisson|||The data below applies to Urgent Care visits||1.38|0.51|0.497
71716338|NCT01908140|142947157|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin=-0,055 L|Mean Difference (Final Values)|0.093|||<|0.001|TWO_SIDED|95.0|0.063|0.123|||MMRM|If non-inferiority on the PP was achieved then switch to superiority was tested on the ITT.||This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0,055 L||0.123|0.063|<0.001
71716339|NCT01908140|142947158|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority limit -0.5 units|Mean Difference (Final Values)|-0.001|||>|0.05|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0,5||0.46|-0.46|>0.05
71716340|NCT01436110|142947165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.43|TWO_SIDED|95.0|-0.055|0.128|||ANCOVA|||||0.128|-0.055|0.430
71716341|NCT01436110|142947165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102||||0.03|TWO_SIDED|95.0|0.01|0.194|||ANCOVA|||||0.194|0.010|0.030
71716342|NCT01088503|142947178|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7108|TWO_SIDED|95.0|0.88|1.22||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank|||||1.22|0.88|0.7108
71716343|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.464|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with DES vs BMS.|||||
71716344|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI|||||
71716345|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.657|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.|||||
71716346|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.684|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.|||||
71716347|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were male vs not male.|||||
71716348|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. \<1.|||||
71716349|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.116|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who were married vs not married.|||||
71716350|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.125|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.|||||
71656783|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.13|2.83||||||Common serotypes - serotype 9V||2.83|-3.13|
71656784|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.1|||||TWO_SIDED|95.0|-3.97|1.73||||||Common serotypes - serotype 9V||1.73|-3.97|
71656785|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||TWO_SIDED|95.0|-3.81|1.88||||||Common serotypes - serotype 9V||1.88|-3.81|
71716351|NCT01088503|142947179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.|||||
71716352|NCT01088503|142947180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.1882|TWO_SIDED|95.0|0.88|1.93||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||Hazard ratio (HR) is for the analysis at 12 months.|||1.93|0.88|0.1882
71716353|NCT01088503|142947181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.967|||||TWO_SIDED|95.0|0.849|1.103|||||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|||1.103|0.849|
71716354|NCT01088503|142947185|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.|||||
71716355|NCT01088503|142947186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.005|||||TWO_SIDED||||||||Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.|||||
71716356|NCT00186628|142947194|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Log Rank|||||||.07
71716357|NCT01076010|142947210|OTHER||25% Quartile (months)|8.0|||||TWO_SIDED|95.0|4.4|12.9||||||||12.9|4.4|
71716358|NCT01076010|142947210|OTHER||50% Quartile (months)|15.2|||||TWO_SIDED|95.0|11.1||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||11.1|
71716359|NCT01076010|142947210|OTHER||25% Quartile (months)|12.9|||||TWO_SIDED|95.0|5.6||DR was only summarized for subjects who had an objective tumor response. Upper limit of confidence interval could not be determined.||||||||5.6|
71716360|NCT01076010|142947211|OTHER||25% Quartile (months)|3.6|||||TWO_SIDED|95.0|1.9|5.2||||||||5.2|1.9|
71716361|NCT01076010|142947211|OTHER||50% Quartile (months)|11.0|||||TWO_SIDED|95.0|7.3|12.7||||||||12.7|7.3|
71716362|NCT01076010|142947211|OTHER||75% Quartile (months)|20.9|||||TWO_SIDED|95.0|16.5||For the subjects in each treatment arm, PFS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||16.5|
71716363|NCT01076010|142947211|OTHER||25% Quartile (months)|7.2|||||TWO_SIDED|95.0|3.5|9.2||||||||9.2|3.5|
71716364|NCT01076010|142947212|OTHER||25% Quartile (months)|8.2|||||TWO_SIDED|95.0|6.0|12.1||||||||12.1|6.0|
71716365|NCT01076010|142947212|OTHER||50% Quartile (months)|21.6|||||TWO_SIDED|95.0|17.0|27.6||||||||27.6|17.0|
71887096|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.28|||||TWO_SIDED|90.0|76.52|134.06||||||Naloxone-3-β-D-Glucuronide||134.06|76.52|
71656786|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.27|1.95||||||Common serotypes - serotype 14||1.95|-1.27|
71767839|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.213||0.664|TWO_SIDED|95.0|-0.51|0.326||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.326|-0.510|0.664
71767840|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767841|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.229||0.417|TWO_SIDED|95.0|-0.638|0.265||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.265|-0.638|0.417
71767842|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767843|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.227||0.217|TWO_SIDED|95.0|-0.727|0.166||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.166|-0.727|0.217
71767844|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767845|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.231||0.753|TWO_SIDED|95.0|-0.381|0.526||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.526|-0.381|0.753
71767846|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767847|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.257||0.362|TWO_SIDED|95.0|-0.74|0.27||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.270|-0.740|0.362
71767848|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|1.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767849|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.256||0.78|TWO_SIDED|95.0|-0.432|0.575||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.575|-0.432|0.780
71828570|NCT04673851|143161791|OTHER|Single group mean difference between baseline and mid-treatment assessments.|Mean Difference (Net)|2.17|STANDARD_DEVIATION|7.84|||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71828571|NCT04673851|143161791|OTHER|Effect size of single group mean difference between baseline and mid-treatment assessments.|Cohen's d|0.28|||||TWO_SIDED|||||||||Midtreatment - Baseline: 30 participants analyzed (had data at both timepoints)||||
71656787|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.1|||||TWO_SIDED|95.0|-0.6|3.01||||||Common serotypes - serotype 14||3.01|-0.60|
71656788|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.04|2.76||||||Common serotypes - serotype 14||2.76|-1.04|
71656789|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.1|||||TWO_SIDED|95.0|-0.38|4.74||||||Common serotypes - serotype 18C||4.74|-0.38|
71656790|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.33|1.99||||||Common serotypes - serotype 18C||1.99|-2.33|
71656791|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.2|||||TWO_SIDED|95.0|-4.89|0.23||||||Common serotypes - serotype 18C||0.23|-4.89|
71656792|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.93|2.6||||||Common serotypes - serotype 19F||2.60|-1.93|
71656793|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.46|0.28||||||Common serotypes - serotype 19F||0.28|-3.46|
71656794|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.8|||||TWO_SIDED|95.0|-3.87|0.02||||||Common serotypes - serotype 19F||0.02|-3.87|
71828572|NCT04673851|143161791|OTHER|Single group mean difference between baseline and post-treatment assessments.|Mean Difference (Net)|6.48|STANDARD_DEVIATION|8.5|||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71716366|NCT01076010|142947212|OTHER||75% Quartile (months)|30.7|||||TWO_SIDED|95.0|28.8||For the subjects in each treatment arm, OS is calculated from the first dose date of the respective study drugs. Upper limit of confidence interval could not be determined.||||||||28.8|
71716367|NCT03767881|142947221|NON_INFERIORITY|The upper limit of a 97.8% confidence limit of the mean days to resolution of acute cholecystitis is compared to a Performance Goal of 3.5 days.|Mean Difference (Final Values)|3.5|||||ONE_SIDED|97.8||10.78|||t-test, 1 sided|||||10.78||
71716368|NCT03767881|142947222|NON_INFERIORITY|The upper limit of a 99.7% confidence limit of the proportion of patients with reintervention, including migration and occlusion, is compared to a Performance Goal of 46.2%.|Performance Goal|16.7|||||ONE_SIDED|99.7||42.0|||1-sided Clopper-Pearson 99.7% CI|||||42.0||
71716369|NCT03498716|142947251|SUPERIORITY|Stratified Analysis: The stratification factors used in the analysis are axillary nodal status, surgery (breast conserving vs. mastectomy),and tumor PD-L1 status.|Hazard Ratio (HR)|1.11||||0.3846|TWO_SIDED|95.0|0.87|1.42|||Log Rank|||||1.42|0.87|0.3846
71716370|NCT00265850|142947265|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.08|TWO_SIDED|95.0|0.77|1.01|||Log Rank|||||1.01|0.77|0.08
71716371|NCT00265850|142947266|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Log Rank|||||1.08|0.84|0.45
71716372|NCT02797821|142947308|OTHER||Least Squares (LS) Means Difference|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.544|-1.216||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the previous comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-1.216|-2.544|<0.0001
71716373|NCT02797821|142947308|OTHER||LS Means Difference|-1.193||||0.0008|TWO_SIDED|95.0|-1.805|-0.581||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥median vs \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the first comparison at a significance level of 0.05 (p-value \<0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values \<0.05).||-0.581|-1.805|0.0008
71716374|NCT02797821|142947309|OTHER||LS Means Difference|-34.047||||0.0128|TWO_SIDED|95.0|-60.171|-7.922||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-7.922|-60.171|0.0128
71716375|NCT02797821|142947309|OTHER||LS Means Difference|-29.492||||0.0239|TWO_SIDED|95.0|-54.723|-4.261||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group \[≥ median versus \< median\], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.||||-4.261|-54.723|0.0239
71716376|NCT02271529|142947310|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power \> 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.|Mean percent change|-1.0|||<|0.01|TWO_SIDED|95.0|-1.5|-0.4|||two one-sided t-tests|||||-0.4|-1.5|<0.01
71828573|NCT04673851|143161791|OTHER|Effect size of single group mean difference between baseline and post-treatment assessments.|Cohen's d|0.76|||||TWO_SIDED|||||||||Posttreatment - Baseline: 27 participants analyzed (had data at both timepoints)||||
71716377|NCT01492426|142947321|NON_INFERIORITY_OR_EQUIVALENCE|Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI \> -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.|Percentage difference|4.3|STANDARD_DEVIATION|3.885|||TWO_SIDED|95.0|-3.3|11.9||Test of noninferiority carried out by taking a confidence interval (CI) for the difference in rates (daclatasvir arm minus telapravir arm). If lower bound of 95% CI difference exceeded -12%, noninferiority was demonstrated. No p-value was computed.|Stratum-adjusted Mantel-Haenszel|||Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.||11.9|-3.3|
71716378|NCT02026011|142947334|SUPERIORITY_OR_OTHER|||||||0.39||||||Medication effect: b = -0.15, SE = 0.17, t = -0.86, p = 0.39|Mixed Models Analysis|||||||0.39
71716379|NCT02026011|142947334|SUPERIORITY_OR_OTHER|||||||0.34||||||Genotype effect: b = 0.20, SE = 0.21, t = 0.96, p = 0.34|Mixed Models Analysis|||||||0.34
71828574|NCT04673851|143161792|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|4.11|STANDARD_DEVIATION|6.86|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71716380|NCT02026011|142947334|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.13, SE = 0.06, t = 2.10, p = 0.04|Mixed Models Analysis|||||||0.04
71716381|NCT02026011|142947334|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = 0.15, SE = 0.21, t = 0.73, p = 0.47|Mixed Models Analysis|||||||0.47
71887097|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|145.99|||||TWO_SIDED|90.0|111.43|191.26||||||Naloxone-3-β-D-Glucuronide||191.26|111.43|
71828575|NCT04673851|143161792|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.6|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71716382|NCT02026011|142947334|SUPERIORITY_OR_OTHER|||||||0.13||||||Medication by genotype by BrAC interaction: b = -0.20, SE = 0.13, t = -1.52, p = 0.13|Mixed Models Analysis|||||||0.13
71716383|NCT02026011|142947335|SUPERIORITY_OR_OTHER|||||||0.23||||||Medication effect: b = 0.16, SE = 0.13, t = 1.20, p = 0.23|Mixed Models Analysis|||||||0.23
71716384|NCT02026011|142947335|SUPERIORITY_OR_OTHER|||||||0.09||||||Genotype effect: b = 0.37, SE = 0.22, t = 1.69, p = 0.09|Mixed Models Analysis|||||||0.09
71716385|NCT02026011|142947335|SUPERIORITY_OR_OTHER|||||||0.84||||||Medication by genotype interaction: b = 0.04, SE = 0.21, t = 0.20, p = 0.84|Mixed Models Analysis|||||||0.84
71716386|NCT02026011|142947335|SUPERIORITY_OR_OTHER|||||||0.05||||||Medication by genotype by BrAC interaction: b = -0.32, SE = 0.16, t = -1.93, p = 0.05|Mixed Models Analysis|||||||0.05
71716387|NCT02026011|142947336|SUPERIORITY_OR_OTHER|||||||0.55||||||Medication effect: b = 0.14, SE = 0.23, t = 0.61, p = 0.55|Mixed Models Analysis|||||||0.55
71716388|NCT02026011|142947336|SUPERIORITY_OR_OTHER|||||||0.77||||||Genotype effect: b = -0.11, SE = 0.37, t = -0.30, p = 0.77|Mixed Models Analysis|||||||0.77
71716389|NCT02026011|142947336|SUPERIORITY_OR_OTHER|||||||0.04||||||BrAC effect: b = 0.30, SE = 0.15, t = 2.02, p = 0.04|Mixed Models Analysis|||||||0.04
71716390|NCT02026011|142947336|SUPERIORITY_OR_OTHER|||||||0.47||||||Medication by genotype interaction: b = -0.21, SE = 0.29, t = -0.72, p = 0.47|Mixed Models Analysis|||||||0.47
71716391|NCT02026011|142947336|SUPERIORITY_OR_OTHER|||||||0.19||||||Medication by genotype by BrAC interaction: b = 0.28, SE = 0.21, t = 1.30, p = 0.19|Mixed Models Analysis|||||||0.19
71716392|NCT02026011|142947338|SUPERIORITY_OR_OTHER|||||||0.14||||||Medication effect: F(1,71) = 2.24, p = 0.14|Poisson Regression|||||||0.14
71716393|NCT02026011|142947338|SUPERIORITY_OR_OTHER|||||||0.02||||||Genotype effect: F(1, 71) = 5.79, p = 0.02|Poisson|||||||0.02
71716394|NCT02026011|142947338|SUPERIORITY_OR_OTHER|||||||0.41||||||Medication by genotype interaction: F(1, 70) = 0.68, p = 0.41.|Poisson|||||||0.41
71716395|NCT02013609|142947369|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in MADRS total score at Week 12 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71716396|NCT02013609|142947370|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71716397|NCT02013609|142947375|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction.||Statistical analysis at Week 12.||||<0.0001
71716398|NCT02013609|142947376|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71716399|NCT02013609|142947377|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities||||<0.0001
71716400|NCT02013609|142947378|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71716401|NCT02013609|142947379|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
71716402|NCT02013609|142947380|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12||||<0.0001
71716403|NCT02013609|142947381|SUPERIORITY_OR_OTHER|||||||0.3439|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (Go cues)||||0.3439
71716404|NCT02013609|142947381|SUPERIORITY_OR_OTHER|||||||0.3385|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)||||0.3385
71716405|NCT02013609|142947382|SUPERIORITY_OR_OTHER|||||||0.2052|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (Go cues)||||0.2052
71716406|NCT02013609|142947382|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (No-Go cues)||||0.3224
71716407|NCT02013609|142947383|SUPERIORITY_OR_OTHER|||||||0.3169|TWO_SIDED||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12||||0.3169
71716408|NCT02013609|142947384|SUPERIORITY_OR_OTHER|||||||0.3352|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12||||0.3352
71716409|NCT02013609|142947385|SUPERIORITY_OR_OTHER|||||||0.3517|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task k value||||0.3517
71716410|NCT02013609|142947385|SUPERIORITY_OR_OTHER|||||||0.3799|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task h value||||0.3799
71716411|NCT02013609|142947386|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for food)||||0.2610
71716412|NCT02013609|142947386|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
71716413|NCT02013609|142947387|SUPERIORITY_OR_OTHER|||||||0.8138|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)||||0.8138
71716414|NCT02013609|142947388|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.||||<0.0001
71716415|NCT00856609|142947389|OTHER||Slope|-624.8||||0.01|TWO_SIDED|95.0|-901.8|-347.8|||ANCOVA|||||-347.8|-901.8|0.01
71716416|NCT00856609|142947390|OTHER||Slope|-24.0||||0.01|TWO_SIDED|95.0|-89.7|41.4|||ANCOVA|||||41.4|-89.7|0.01
71716417|NCT00856609|142947391|OTHER||Slope|-1.48||||0.05|TWO_SIDED|95.0|-3.02|0.05|||ANCOVA|||||0.05|-3.02|0.05
71716418|NCT00783432|142947394|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||This is the Baseline P-Value|ANOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.368
71716419|NCT00783432|142947394|SUPERIORITY_OR_OTHER|||||||0.327||95.0||||This P-Value if for Month 1|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.327
71716420|NCT00783432|142947394|SUPERIORITY_OR_OTHER|||||||0.991||95.0||||This P-Value is for Month 3|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.991
71716421|NCT00783432|142947394|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||This P-Value is for Month 6|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.168
71716422|NCT00783432|142947394|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||This P-Value is for Month 9|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.319
71716423|NCT00783432|142947394|SUPERIORITY_OR_OTHER|||||||0.725||||||This P-Value is for Month 12/ET|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.||||0.725
71716424|NCT03273907|142947395|SUPERIORITY|The primary null hypothesis tested was that the observed rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability is greater than or equal to the performance target rate of 7.00 percent.||||||0.187|||||||Exact one-sided binomial test|P-value is provided from exact one-sided binomial test with type I error 0.05 comparing CyPass System with performance criterion of 7.00 percent.||||||0.1870
71716425|NCT00110214|142947402|NON_INFERIORITY_OR_EQUIVALENCE|Superiority and futility analyses were conducted for the OS end point. The Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain the overall significance level of alpha=0.05 while conducting interim analyses on OS. The final analysis was performed when 748 deaths had been observed. An intention-to-treat approach was used in the analysis for all the clinical end points with the exception of toxicity.|Hazard Ratio (HR)|0.91||||0.181|TWO_SIDED|95.0|0.7|1.05||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||1.05|0.7|0.181
71716426|NCT00110214|142947403|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71716427|NCT00110214|142947404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.001|TWO_SIDED|95.0|0.71|0.91||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (\<10%,10%-29.9%,\>=30%), age (\<65, \>=65 years) and prior history of arterial events (yes, no)).|Log Rank|||||0.91|0.71|<0.001
71716428|NCT02581891|142947406|NON_INFERIORITY|The non-inferiority margin is set to 5 letters.|LS mean difference|-2.0199|STANDARD_ERROR_OF_MEAN|1.3833||0.0162|TWO_SIDED|95.0|-4.747|0.7073|||ANCOVA|||||0.7073|-4.7470|0.0162
71716429|NCT01247064|142947416|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71828576|NCT04673851|143161792|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.77|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
71716430|NCT01247064|142947417|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
71716431|NCT01247064|142947418|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71716432|NCT01247064|142947419|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
71716433|NCT01247064|142947420|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
71716434|NCT00448448|142947437|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93|||<|0.0267|TWO_SIDED|95.0|1.08|3.46|||Regression, Logistic|The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.||||3.46|1.08|<0.0267
71828577|NCT04673851|143161792|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.11|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
71828578|NCT04673851|143161792|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71716435|NCT04436744|142947490|SUPERIORITY|||||||0.0433|||||||t-test, 2 sided|||||||0.0433
71716436|NCT04436744|142947491|SUPERIORITY||Difference in Overall Response Rates|-0.93||||0.8272|TWO_SIDED|95.0|-14.66|12.81|||Cochran-Mantel-Haenszel|||ORR was calculated using the stratified Cochran-Mantel-Haenszel test.||12.81|-14.66|0.8272
71716437|NCT04436744|142947492|SUPERIORITY||Difference in Rate|6.86|||||TWO_SIDED|95.0|-4.25|17.97||||||||17.97|-4.25|
71716438|NCT01374425|142947542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0555|TWO_SIDED|95.0|0.61|1.01||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||Hazard ratio (HR) (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low excision repair cross-complementing (ERCC)-1 level and region of enrollment.||1.01|0.61|0.0555
71828579|NCT04673851|143161792|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.03|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71656795|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.2|||||TWO_SIDED|95.0|-1.03|7.46||||||Common serotypes - serotype 23F||7.46|-1.03|
71656796|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|4.0|||||TWO_SIDED|95.0|-0.27|8.39||||||Common serotypes - serotype 23F||8.39|-0.27|
71716439|NCT01374425|142947543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3944|TWO_SIDED|95.0|0.56|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.56|0.3944
71716440|NCT01374425|142947544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0786|TWO_SIDED|95.0|0.55|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.55|0.0786
71716441|NCT01374425|142947545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9576|TWO_SIDED|95.0|0.77|1.28||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.77|0.9576
71828580|NCT04673851|143161792|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.63|STANDARD_DEVIATION|7.95|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828581|NCT04673851|143161792|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828582|NCT04673851|143161793|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|1.68|STANDARD_DEVIATION|3.76|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71656797|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-3.75|5.46||||||Common serotypes - serotype 23F||5.46|-3.75|
71656798|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-1.48|3.18||||||Additional serotypes - serotype 1||3.18|-1.48|
71656799|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.78|1.34||||||Additional serotypes - serotype 1||1.34|-2.78|
71656800|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||TWO_SIDED|95.0|-3.77|0.67||||||Additional serotypes - serotype 1||0.67|-3.77|
71656801|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-3.9|||||TWO_SIDED|95.0|-10.27|2.45||||||Additional serotypes - serotype 3||2.45|-10.27|
71656802|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-10.7|||||TWO_SIDED|95.0|-16.8|-4.57||||||Additional serotypes - serotype 3||-4.57|-16.80|
71656803|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-6.8|||||TWO_SIDED|95.0|-12.76|-0.74||||||Additional serotypes - serotype 3||-0.74|-12.76|
71656804|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.9|||||TWO_SIDED|95.0|0.15|7.69||||||Additional serotypes - serotype 5||7.69|0.15|
71656805|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-3.52|3.09||||||Additional serotypes - serotype 5||3.09|-3.52|
71656806|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.1|||||TWO_SIDED|95.0|-7.92|-0.36||||||Additional serotypes - serotype 5||-0.36|-7.92|
71656807|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.5|||||TWO_SIDED|95.0|0.12|5.23||||||Additional serotypes - serotype 6A||5.23|0.12|
71656808|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||TWO_SIDED|95.0|-2.22|1.86||||||Additional serotypes - serotype 6A||1.86|-2.22|
71656809|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.7|||||TWO_SIDED|95.0|-5.39|-0.27||||||Additional serotypes - serotype 6A||-0.27|-5.39|
71828583|NCT04673851|143161793|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.45|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71716442|NCT01374425|142947546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.1658|TWO_SIDED|95.0|0.93|1.53||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.53|0.93|0.1658
71716443|NCT01374425|142947547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.3019|TWO_SIDED|95.0|0.41|1.32||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.32|0.41|0.3019
71716444|NCT01374425|142947548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6035|TWO_SIDED|95.0|0.48|1.53||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.53|0.48|0.6035
71716445|NCT01374425|142947549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4032|TWO_SIDED|95.0|0.54|1.28||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.28|0.54|0.4032
71716446|NCT01374425|142947550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0647|TWO_SIDED|95.0|0.41|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.03|0.41|0.0647
71716447|NCT01374425|142947551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0861|TWO_SIDED|95.0|0.56|1.04||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.04|0.56|0.0861
71716448|NCT01374425|142947552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3295|TWO_SIDED|95.0|0.51|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.26|0.51|0.3295
71716449|NCT01374425|142947553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.1519|TWO_SIDED|95.0|0.49|1.12||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.12|0.49|0.1519
71716450|NCT01374425|142947554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2774|TWO_SIDED|95.0|0.87|1.62||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.||1.62|0.87|0.2774
71767850|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71716451|NCT01374425|142947555|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|4.3|||||TWO_SIDED|95.0|-5.5|14.0|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.0|-5.5|
71716452|NCT01374425|142947556|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|9.4|||||TWO_SIDED|95.0|7.2|26.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||26.1|7.2|
71716453|NCT01374425|142947557|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|2.1|||||TWO_SIDED|95.0|-9.9|14.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||14.1|-9.9|
71716454|NCT01374425|142947558|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-3.7|||||TWO_SIDED|95.0|-14.0|6.6|||||The difference was calculated as the percentage of participants with objective response in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||6.6|-14.0|
71716455|NCT01374425|142947559|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.1|||||TWO_SIDED|95.0|-7.6|3.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-7.6|
71716456|NCT01374425|142947560|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-8.7|||||TWO_SIDED|95.0|-19.1|1.7|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||1.7|-19.1|
71716457|NCT01374425|142947561|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|2.3|||||TWO_SIDED|95.0|-3.7|8.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||8.3|-3.7|
71767851|NCT02880956|143037263|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.263||0.974|TWO_SIDED|95.0|-0.526|0.509||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.509|-0.526|0.974
71767852|NCT02880956|143037263|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71656810|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||TWO_SIDED|95.0|-0.47|2.3||||||Additional serotypes - serotype 7F||2.30|-0.47|
71716458|NCT01374425|142947562|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-4.5|||||TWO_SIDED|95.0|-10.6|1.5|||||The difference was calculated as the percentage of participants with disease control in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||1.5|-10.6|
71716459|NCT01374425|142947563|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.0|||||TWO_SIDED|95.0|-15.9|7.8|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||7.8|-15.9|
71716460|NCT01374425|142947564|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-6.5|||||TWO_SIDED|95.0|-16.3|3.3|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||3.3|-16.3|
71716461|NCT01374425|142947565|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
71767853|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.139||0.976|TWO_SIDED|95.0|-0.269|0.278||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.278|-0.269|0.976
71767854|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||Week 24||||
71767855|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.137||0.85|TWO_SIDED|95.0|-0.244|0.296||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.296|-0.244|0.850
71767856|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767857|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.981|TWO_SIDED|95.0|-0.281|0.275||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.275|-0.281|0.981
71767858|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767859|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.163||0.989|TWO_SIDED|95.0|-0.323|0.318||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.318|-0.323|0.989
71767860|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828584|NCT04673851|143161793|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|2.73|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
71828585|NCT04673851|143161793|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.02|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
71656811|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-1.12|1.18||||||Additional serotypes - serotype 7F||1.18|-1.12|
71716462|NCT01374425|142947566|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-11.0|||||TWO_SIDED|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||11.1|-33.1|
71716463|NCT01374425|142947567|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.0|||||TWO_SIDED|95.0|-10.1|4.2|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||4.2|-10.1|
71716464|NCT01374425|142947568|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-5.5|||||TWO_SIDED|95.0|-11.5|0.4|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.|||0.4|-11.5|
71716465|NCT01374425|142947569|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-4.4|||||TWO_SIDED|95.0|-9.5|0.6|||||The difference was calculated as the percentage of participants with resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||0.6|-9.5|
71767861|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.97|TWO_SIDED|95.0|-0.319|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.307|-0.319|0.970
71767862|NCT02880956|143037264|SUPERIORITY||effect size|0.0|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71887098|NCT01846455|143294668|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.64|||||TWO_SIDED|90.0|81.33|142.47||||||Naloxone-3-β-D-Glucuronide||142.47|81.33|
71716466|NCT01374425|142947570|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-1.6|||||TWO_SIDED|95.0|-6.2|3.1|||||The difference was calculated as the percentage of participants with complete resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.1|-6.2|
71716467|NCT01374425|142947571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0593|TWO_SIDED|95.0|0.99|1.69||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.69|0.99|0.0593
71716468|NCT01374425|142947572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.2|2.24||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||2.24|1.20|0.0020
71716469|NCT01374425|142947573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.0955|TWO_SIDED|95.0|0.95|1.88||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.||1.88|0.95|0.0955
71716470|NCT01374425|142947574|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.9|||||TWO_SIDED|95.0|-15.7|3.8|||||The difference was calculated as the percentage of participants with objective response in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||3.8|-15.7|
71767863|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.215|TWO_SIDED|95.0|-0.526|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.526|0.215
71767864|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|1.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767865|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.163||0.665|TWO_SIDED|95.0|-0.392|0.25||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.250|-0.392|0.665
71767866|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767867|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.162||0.059|TWO_SIDED|95.0|-0.625|0.012||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.012|-0.625|0.059
71767868|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767869|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.164||0.663|TWO_SIDED|95.0|-0.394|0.251||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.251|-0.394|0.663
71828586|NCT04673851|143161793|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|-0.56|STANDARD_DEVIATION|2.44|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828587|NCT04673851|143161793|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.23|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828588|NCT04673851|143161793|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-0.59|STANDARD_DEVIATION|3.15|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71767870|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767871|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193||0.866|TWO_SIDED|95.0|-0.413|0.348||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.348|-0.413|0.866
71767872|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767873|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.471|TWO_SIDED|95.0|-0.514|0.238||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.238|-0.514|0.471
71767874|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767875|NCT02880956|143037264|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.198||0.604|TWO_SIDED|95.0|-0.493|0.287||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.287|-0.493|0.604
71828589|NCT04673851|143161793|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.19|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71887099|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|120.02|||||TWO_SIDED|90.0|83.35|172.82||||||Buprenorphine||172.82|83.35|
71716471|NCT01374425|142947575|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|-5.4|||||TWO_SIDED|95.0|-16.0|5.2|||||The difference was calculated as the percentage of participants with objective response in the KRAS Mutant subgroup minus the KRAS Wild-Type subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||5.2|-16.0|
71716472|NCT01374425|142947576|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-1.1|||||TWO_SIDED|95.0|-6.5|4.3|||||The difference was calculated as the percentage of participants with disease control in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||4.3|-6.5|
71716473|NCT01374425|142947577|SUPERIORITY_OR_OTHER||Difference in Resection Rates|-3.2|||||TWO_SIDED|95.0|-8.6|2.1|||||The difference was calculated as the percentage of participants with resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||2.1|-8.6|
71716474|NCT01374425|142947578|SUPERIORITY_OR_OTHER||Difference in Complete Resection Rates|-4.9|||||TWO_SIDED|95.0|-9.6|-0.2|||||The difference was calculated as the percentage of participants with complete resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.|||-0.2|-9.6|
71716475|NCT01227057|142947610|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.029||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.029
71716476|NCT01227057|142947611|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.04||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.||||.04
71716477|NCT01227057|142947612|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.|||||>|0.1||||||P value is for the group x time interaction.|ANOVA|||||||>.1
71716478|NCT01240863|142947613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.134|TWO_SIDED|95.0|-0.11|0.82||statistical significance level of 0.05.|ANCOVA|Treatment and stratification (opioid naïve/opioid experienced) factors as the fixed effects; screening and baseline APIs as covariates.|placebo - hydrocodone|||0.82|-0.11|0.134
71716479|NCT01419119|142947639|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71716480|NCT01419119|142947640|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71716481|NCT03768427|142947643|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-19.5|||<|0.001|TWO_SIDED|95.0|-26.7|-12.3|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (88 participants in arm Atorvastatin 10 mg - ezetimibe 10 mg/Ator 10 mg and 89 participants in arm Atorvastatin 10mg - Atorvastatin 20 mg)."|Difference in least squares mean is Atorvastatin 10 mg - EZ 10 mg/Ator 10 mg minus Atorvastatin 10mg - Atorvastatin 20 mg.|-12.3|-26.7|<0.001
71716482|NCT03768427|142947643|OTHER|Difference in least squares mean|Mean Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED|95.0|-21.0|-10.7|||Constrained longitudinal model|||"This statistical analysis was performed by fitting a constrained longitudinal model adjusting for time and the interaction of time by treatment, and time by baseline disease risk category, including all participants with baseline data (137 participants in arm Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg and 140 participants in arm Atorvastatin 20 mg - Atorvastatin 40 mg)."|Atorvastatin 20 mg - EZ 10 mg/Ator 20 mg minus Atorvastatin 20 mg - Atorvastatin 40 mg.|-10.7|-21.0|<0.001
71716483|NCT00776789|142947647|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4
71887100|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|107.85|||||TWO_SIDED|90.0|75.85|153.36||||||Buprenorphine||153.36|75.85|
71887101|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|171.76|||||TWO_SIDED|90.0|117.93|250.15||||||Buprenorphine||250.15|117.93|
71887102|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|112.82|||||TWO_SIDED|90.0|77.66|163.91||||||Buprenorphine||163.91|77.66|
71887103|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.38|||||TWO_SIDED|90.0|71.43|158.43||||||Buprenorphine||158.43|71.43|
71887104|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|95.59|||||TWO_SIDED|90.0|64.36|141.99||||||Buprenorphine||141.99|64.36|
71887105|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|152.24|||||TWO_SIDED|90.0|103.08|224.83||||||Buprenorphine||224.83|103.08|
71716484|NCT00776789|142947648|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0||95.0|1.4|4.3|||Wilcoxon (Mann-Whitney)|||Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control group||4.3|1.4|0.00
71716485|NCT00776789|142947649|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001||95.0|1.6|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|1.6|0.001
71716486|NCT02742129|142947650|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.2||||0.265|TWO_SIDED|95.0|-0.56|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.56|0.2650
71716487|NCT02742129|142947651|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis|Mean Difference (Final Values)|-14.68||||0.9069|TWO_SIDED|95.0|-263.65|234.29|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data||234.29|-263.65|0.9069
71716488|NCT02742129|142947652|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.05||||0.9338|TWO_SIDED|95.0|-1.16|1.27|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||1.27|-1.16|0.9338
71887106|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|135.17|||||TWO_SIDED|90.0|75.44|242.16||||||Norbuprenorphine||242.16|75.44|
71887107|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|67.87|||||TWO_SIDED|90.0|38.82|118.68||||||Norbuprenorphine||118.68|38.82|
71887108|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|48.39|||||TWO_SIDED|90.0|27.01|86.69||||||Norbuprenorphine||86.69|27.01|
71887109|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|76.59|||||TWO_SIDED|90.0|42.75|137.22||||||Norbuprenorphine||137.22|42.75|
71887110|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|176.48|||||TWO_SIDED|90.0|94.62|329.17||||||Norbuprenorphine||329.17|94.62|
71716489|NCT02742129|142947653|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.29||||0.8151|TWO_SIDED|95.0|-2.79|2.2|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||2.20|-2.79|0.8151
71716490|NCT02742129|142947654|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.82||||0.4658|TWO_SIDED|95.0|-1.41|3.05|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.05|-1.41|0.4658
71887111|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|88.62|||||TWO_SIDED|90.0|48.6|161.59||||||Norbuprenorphine||161.59|48.60|
71767876|NCT02880956|143037264|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71887112|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|63.17|||||TWO_SIDED|90.0|33.87|117.83||||||Norbuprenorphine||117.83|33.87|
71887113|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|100.41|||||TWO_SIDED|90.0|51.3|196.53||||||Naloxone||196.53|51.30|
71887114|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|270.0|||||TWO_SIDED|90.0|141.86|513.9||||||Naloxone||513.90|141.86|
71887115|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1129.81|||||TWO_SIDED|90.0|577.22|2211.44||||||Naloxone||2211.44|577.22|
71887116|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|126.25|||||TWO_SIDED|90.0|64.5|247.11||||||Naloxone||247.11|64.50|
71887117|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|79.53|||||TWO_SIDED|90.0|38.79|163.06||||||Naloxone||163.06|38.79|
71887118|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|213.86|||||TWO_SIDED|90.0|107.07|427.17||||||Naloxone||427.17|107.07|
71887119|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|894.91|||||TWO_SIDED|90.0|436.49|1834.8||||||Naloxone||1834.80|436.49|
71887120|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.03|||||TWO_SIDED|90.0|85.94|143.44||||||Naloxone-3-β-D-Glucuronide||143.44|85.94|
71887121|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|111.22|||||TWO_SIDED|90.0|87.02|142.16||||||Naloxone-3-β-D-Glucuronide||142.16|87.02|
71887122|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.09|||||TWO_SIDED|90.0|64.32|107.35||||||Naloxone-3-β-D-Glucuronide||107.35|64.32|
71887123|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|83.66|||||TWO_SIDED|90.0|64.75|108.08||||||Naloxone-3-β-D-Glucuronide||108.08|64.75|
71887124|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.72|||||TWO_SIDED|90.0|100.93|174.53||||||Naloxone-3-β-D-Glucuronide||174.53|100.93|
71887125|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.95|||||TWO_SIDED|90.0|102.12|173.1||||||Naloxone-3-β-D-Glucuronide||173.10|102.12|
71887126|NCT01846455|143294669|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.33|||||TWO_SIDED|90.0|75.54|130.61||||||Naloxone-3-β-D-Glucuronide||130.61|75.54|
71887127|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|125.19|||||TWO_SIDED|90.0|79.46|197.24||||||Buprenorphine||197.24|79.46|
71887128|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|220.97|||||TWO_SIDED|90.0|135.33|360.81||||||Buprenorphine||360.81|135.33|
71887129|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|249.28|||||TWO_SIDED|90.0|162.19|383.14||||||Buprenorphine||383.14|162.19|
71716491|NCT02742129|142947655|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|1.06||||0.3902|TWO_SIDED|95.0|-1.37|3.49|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||3.49|-1.37|0.3902
71716492|NCT02742129|142947656|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|10.69||||0.7404|TWO_SIDED|95.0|-53.21|74.6|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||74.6|-53.21|0.7404
71716493|NCT02742129|142947657|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Median Difference (Final Values)|0.05||||0.4282|TWO_SIDED|95.0|-0.08|0.18|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.18|-0.08|0.4282
71716494|NCT02742129|142947659|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.49||||0.1067|TWO_SIDED|95.0|-1.08|0.11|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.11|-1.08|0.1067
71716495|NCT02742129|142947660|SUPERIORITY|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.1||||0.4411|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.||0.16|-0.37|0.4411
71716496|NCT02629861|142947668|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71716497|NCT02629861|142947668|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71716498|NCT02629861|142947670|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71767877|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.069||0.325|TWO_SIDED|95.0|-0.067|0.202||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.202|-0.067|0.325
71767878|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828590|NCT04673851|143161794|OTHER|Single group mean difference between mid-treatment and post-treatment assessments.|Mean Difference (Net)|2.42|STANDARD_DEVIATION|4.48|||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71716499|NCT02629861|142947670|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71716500|NCT02629861|142947670|SUPERIORITY|||||||0.0032||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0032
71716501|NCT02629861|142947670|SUPERIORITY|||||||0.001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0010
71767879|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.067||0.51|TWO_SIDED|95.0|-0.177|0.088||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.088|-0.177|0.510
71828591|NCT04673851|143161794|OTHER|Effect size of single group mean difference between mid-treatment and post-treatment assessments.|Cohen's d|0.54|||||TWO_SIDED|||||||||Posttreatment - Midtreatment: 19 participants analyzed (had data at both timepoints)||||
71716502|NCT02629861|142947670|SUPERIORITY|||||||0.0048||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0048
71716503|NCT02629861|142947670|SUPERIORITY|||||||0.0003||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||0.0003
71716504|NCT02629861|142947670|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71716505|NCT02629861|142947670|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.||||<0.0001
71716506|NCT02629861|142947671|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71716507|NCT02629861|142947671|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71767880|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767881|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.069||0.601|TWO_SIDED|95.0|-0.1|0.172||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.172|-0.100|0.601
71767882|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767883|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.157|0.119||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.119|-0.157|0.783
71828592|NCT04673851|143161794|OTHER|Single group mean difference between 1.5 month and mid-treatment assessments.|Mean Difference (Net)|0.83|STANDARD_DEVIATION|5.05|||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
71716508|NCT02629861|142947672|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71828593|NCT04673851|143161794|OTHER|Effect size of single group mean difference between 1.5 month and mid-treatment assessments.|Cohen's d|0.17|||||TWO_SIDED|||||||||Midtreatment - 1.5 Months: 30 participants analyzed (had data at both timepoints)||||
71716509|NCT02629861|142947672|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint||||<0.0001
71716510|NCT02629861|142947673|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
71828594|NCT04673851|143161794|OTHER|Single group mean difference between 1.5 month and 4.5 month assessments.|Mean Difference (Net)|0.41|STANDARD_DEVIATION|4.55|||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71716511|NCT02629861|142947673|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||<0.0001
71767884|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767885|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.068||0.646|TWO_SIDED|95.0|-0.165|0.103||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.103|-0.165|0.646
71767886|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828595|NCT04673851|143161794|OTHER|Effect size of single group mean difference between 1.5 month and 4.5 month assessments.|Cohen's d|0.09|||||TWO_SIDED|||||||||4.5 Months - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828596|NCT04673851|143161794|OTHER|Single group mean difference between 1.5 month and post-treatment assessments.|Mean Difference (Net)|-2.04|STANDARD_DEVIATION|6.12|||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828597|NCT04673851|143161794|OTHER|Effect size of single group mean difference between 1.5 month and post-treatment assessments.|Cohen's d|0.33|||||TWO_SIDED|||||||||Posttreatment - 1.5 Months: 27 participants analyzed (had data at both timepoints)||||
71828598|NCT02954848|143161816|SUPERIORITY||Median Difference (Final Values)|3.8||||0.0643|TWO_SIDED|95.0|0.0|10.6|||Wilcoxon Rank-Sum Test||The point estimate of the median difference between the treatment groups was calculated using the Hodges-Lehmann estimation.|||10.600|0.000|0.0643
71828599|NCT02954848|143161817|SUPERIORITY|||||||0.0003|||||||Log Rank|||||||0.0003
71828600|NCT02954848|143161818|SUPERIORITY||Median Difference (Final Values)|-0.11||||0.0826|TWO_SIDED|95.0|-0.24|0.01|||Wilcoxon Rank-Sum Test|||||0.0100|-0.2400|0.0826
71828601|NCT02954848|143161819|SUPERIORITY||Median Difference (Final Values)|3.3||||0.0478|TWO_SIDED|95.0|0.0|5.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||5.300|0.000|0.0478
71716512|NCT02629861|142947674|SUPERIORITY|||||||0.0023||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0023
71716513|NCT02629861|142947674|SUPERIORITY|||||||0.0021||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.||||0.0021
71716514|NCT01685684|142947682|SUPERIORITY_OR_OTHER_LEGACY||Marginal Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED||||||z-test|||||||<0.0001
71716515|NCT00902330|142947696|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.||||<0.05
71716516|NCT04290624|142947735|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.20|-0.40|<0.0001
71656812|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.3|0.52||||||Additional serotypes - serotype 7F||0.52|-2.30|
71656813|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.0|||||TWO_SIDED|95.0|-2.91|0.8||||||Additional serotypes - serotype 19A||0.80|-2.91|
71716517|NCT04290624|142947736|SUPERIORITY||Mean Difference (Final Values)|-28.6|STANDARD_ERROR_OF_MEAN|4.73|<|0.0001|TWO_SIDED|95.0|-38.1|-19.1|||ANCOVA|||At Week 6||-19.1|-38.1|<0.0001
71716518|NCT04290624|142947736|SUPERIORITY||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|5.08|<|0.0001|TWO_SIDED|95.0|-38.2|-17.7|||ANCOVA|||At Week 12||-17.7|-38.2|<0.0001
71716519|NCT04290624|142947737|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||At Week 6||-0.27|-0.52|<0.0001
71716520|NCT04290624|142947737|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.47|-0.25|||ANCOVA|||At Week 12||-0.25|-0.47|<0.0001
71716521|NCT04290624|142947738|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.14|-0.56|||ANCOVA|||At Week 6||-0.56|-1.14|<0.0001
71767887|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.209|TWO_SIDED|95.0|-0.226|0.05||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.050|-0.226|0.209
71767888|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767889|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.091||0.454|TWO_SIDED|95.0|-0.246|0.11||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.110|-0.246|0.454
71767890|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71716522|NCT04290624|142947738|SUPERIORITY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.139|<|0.0001|TWO_SIDED|95.0|-1.23|-0.67|||ANCOVA|||At Week 12||-0.67|-1.23|<0.0001
71716523|NCT04290624|142947739|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.151|<|0.0001|TWO_SIDED|95.0|-1.22|-0.61|||ANCOVA|||At Week 6||-0.61|-1.22|<0.0001
71716524|NCT04290624|142947739|SUPERIORITY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.36|-0.74|||ANCOVA|||At Week 12||-0.74|-1.36|<0.0001
71716525|NCT04290624|142947740|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.41|-0.23|||ANCOVA|||||-0.23|-0.41|<0.0001
71716526|NCT04290624|142947741|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0039|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||At Week 6||-0.2|-0.9|0.0039
71716527|NCT04290624|142947741|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|||At Week 12||-0.5|-1.1|<0.0001
71716528|NCT04290624|142947742|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0367|TWO_SIDED|95.0|-0.21|-0.01|||ANCOVA|||At Week 6||-0.01|-0.21|0.0367
71716529|NCT04290624|142947742|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.033||0.0725|TWO_SIDED|95.0|-0.14|-0.01|||Van-Elteren test|||At Week 12||-0.01|-0.14|0.0725
71716530|NCT04290624|142947743|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.075||0.0006|TWO_SIDED|95.0|-0.43|-0.13|||ANCOVA|||At Week 6||-0.13|-0.43|0.0006
71767891|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.141|TWO_SIDED|95.0|-0.306|0.043||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.043|-0.306|0.141
71767892|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767893|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.107|TWO_SIDED|95.0|-0.323|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.031|-0.323|0.107
71767894|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.59|||TWO_SIDED|||||||||Week 72||||
71767895|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.961|TWO_SIDED|95.0|-0.243|0.232||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.232|-0.243|0.961
71767896|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.79|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767897|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.618|TWO_SIDED|95.0|-0.29|0.173||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.173|-0.290|0.618
71828602|NCT02954848|143161819|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8963|TWO_SIDED|95.0|-6.1|6.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||6.000|-6.100|0.8963
71716531|NCT04290624|142947743|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.073||0.0009|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||At Week 12||-0.11|-0.41|0.0009
71767898|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767899|NCT02880956|143037265|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.121||0.227|TWO_SIDED|95.0|-0.385|0.092||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.092|-0.385|0.227
71767900|NCT02880956|143037265|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||Week 96||||
71767901|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.056|TWO_SIDED|95.0|-0.009|0.697||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.697|-0.009|0.056
71767902|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.23|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828603|NCT02954848|143161819|SUPERIORITY||Median Difference (Final Values)|5.2||||0.012|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||10.700|0.000|0.0120
71767903|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.177||0.997|TWO_SIDED|95.0|-0.348|0.349||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.349|-0.348|0.997
71767904|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.34|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767905|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.41|STANDARD_ERROR_OF_MEAN|0.182||0.023|TWO_SIDED|95.0|0.056|0.772||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.772|0.056|0.023
71828604|NCT02954848|143161819|SUPERIORITY||Median Difference (Final Values)|-4.7||||0.0871|TWO_SIDED|95.0|-17.4|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.000|-17.400|0.0871
71828605|NCT02954848|143161820|SUPERIORITY|||||||0.0025|||||||Log Rank|||||||0.0025
71828606|NCT02954848|143161821|SUPERIORITY|||||||0.1059|||||||Log Rank|||||||0.1059
71828607|NCT02954848|143161822|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
71828608|NCT02954848|143161823|SUPERIORITY|||||||0.5393|||||||Log Rank|||||||0.5393
71828609|NCT02954848|143161824|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.0505|TWO_SIDED|95.0|-0.21|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response||0.0000|-0.2100|0.0505
71656814|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||TWO_SIDED|95.0|-2.69|1.19||||||Additional serotypes - serotype 19A||1.19|-2.69|
71656815|NCT00444457|142831450|NON_INFERIORITY_OR_EQUIVALENCE|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||TWO_SIDED|95.0|-1.4|2.04||||||Additional serotypes - serotype 19A||2.04|-1.40|
71656816|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.1|||||TWO_SIDED|95.0|-1.61|1.81|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||1.81|-1.61|
71656817|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-2.39|0.23|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.23|-2.39|
71656818|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.54|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||0.20|-2.54|
71656819|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.02|1.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.11|-1.02|
71656820|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.04|-1.03|
71656821|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.13|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.13|
71656822|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.25|1.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.37|-1.25|
71656823|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.76|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.76|
71656824|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-0.87|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||2.18|-0.87|
71828610|NCT02954848|143161824|SUPERIORITY||Median Difference (Final Values)|0.02||||0.8138|TWO_SIDED|95.0|-0.12|0.15|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response||0.1500|-0.1200|0.8138
71828611|NCT02954848|143161824|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.0129|TWO_SIDED|95.0|-0.28|-0.03|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response||-0.0300|-0.2800|0.0129
71828612|NCT02954848|143161824|SUPERIORITY||Median Difference (Final Values)|0.17||||0.0765|TWO_SIDED|95.0|-0.01|0.36|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response||0.3600|-0.0100|0.0765
71828613|NCT02954848|143161825|SUPERIORITY||Median Difference (Final Values)|6.5||||0.149|TWO_SIDED|95.0|-1.9|15.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||15.300|-1.900|0.1490
71828614|NCT02954848|143161825|SUPERIORITY||Median Difference (Final Values)|3.6||||0.2146|TWO_SIDED|95.0|-1.4|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||10.700|-1.400|0.2146
71828615|NCT02954848|143161826|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
71828616|NCT02954848|143161827|SUPERIORITY|||||||0.0153|||||||Log Rank|||||||0.0153
71828617|NCT02954848|143161828|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.0757|TWO_SIDED|95.0|-0.43|0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings||0.0200|-0.4300|0.0757
71828618|NCT02954848|143161828|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.3837|TWO_SIDED|95.0|-0.22|0.09|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings||0.0900|-0.2200|0.3837
71716532|NCT04290624|142947744|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.117||0.002|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||At Week 6||-0.15|-0.62|0.0020
71828619|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6631|TWO_SIDED|95.0|-5.0|3.5|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||3.500|-5.000|0.6631
71828620|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|3.2||||0.5627|TWO_SIDED|95.0|-7.1|13.9|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||13.900|-7.100|0.5627
71828621|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|3.7||||0.0042|TWO_SIDED|95.0|0.0|8.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||8.000|0.000|0.0042
71828622|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.6452|TWO_SIDED|95.0|-9.4|6.4|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||6.400|-9.400|0.6452
71828623|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|7.4||||0.0376|TWO_SIDED|95.0|0.0|17.8|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||17.800|0.000|0.0376
71828624|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.16|TWO_SIDED|95.0|-35.7|3.6|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||3.600|-35.700|0.1600
71828625|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|3.6||||0.1032|TWO_SIDED|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||10.700|0.000|0.1032
71828626|NCT02954848|143161829|SUPERIORITY||Median Difference (Final Values)|-3.3||||0.2613|TWO_SIDED|95.0|-14.3|0.2|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved response||0.200|-14.300|0.2613
71828627|NCT02954848|143161830|SUPERIORITY|||||||0.997|||||||Log Rank|||||||0.9970
71828628|NCT02954848|143161831|SUPERIORITY|||||||0.0125|||||||Log Rank|||||||0.0125
71828629|NCT02954848|143161832|SUPERIORITY|||||||0.0004|||||||Log Rank|||||||0.0004
71828630|NCT02954848|143161833|SUPERIORITY|||||||0.7999|||||||Log Rank|||||||0.7999
71716533|NCT04290624|142947744|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.52|-0.16|||ANCOVA|||At Week 12||-0.16|-0.52|0.0005
71767906|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.3|STANDARD_DEVIATION|1.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828631|NCT02954848|143161834|SUPERIORITY|||||||0.0059|||||||Log Rank|||||||0.0059
71828632|NCT02954848|143161835|SUPERIORITY|||||||0.552|||||||Log Rank|||||||0.5520
71828633|NCT02954848|143161836|SUPERIORITY|||||||0.0175|||||||Log Rank|||||||0.0175
71828634|NCT02954848|143161837|SUPERIORITY|||||||0.7505|||||||Log Rank|||||||0.7505
71828635|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.7845|TWO_SIDED|95.0|-0.23|0.16|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response||0.1600|-0.2300|0.7845
71828636|NCT02954848|143161838|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.11||||0.4456|TWO_SIDED|95.0|-0.33|0.17|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response||0.1700|-0.3300|0.4456
71828637|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response||-0.0200|-0.2900|0.0200
71828638|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|0.06||||0.4673|TWO_SIDED|95.0|-0.1|0.22|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response||0.2200|-0.1000|0.4673
71828639|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|-0.29||||0.0095|TWO_SIDED|95.0|-0.53|-0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response||-0.0700|-0.5300|0.0095
71828640|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|0.31||||0.165|TWO_SIDED|95.0|-0.16|0.71|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response||0.7100|-0.1600|0.1650
71828641|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.2475|TWO_SIDED|95.0|-0.24|0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response||0.0700|-0.2400|0.2475
71828642|NCT02954848|143161838|SUPERIORITY||Median Difference (Final Values)|0.13||||0.2367|TWO_SIDED|95.0|-0.09|0.32|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved||0.3200|-0.0900|0.2367
71828643|NCT02954848|143161839|SUPERIORITY||Median Difference (Final Values)|5.5||||0.1885|TWO_SIDED|95.0|-2.7|14.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||14.300|-2.700|0.1885
71828644|NCT02954848|143161839|SUPERIORITY||Wilcoxon Rank-Sum Test|25.6||||0.2337|TWO_SIDED|95.0|-19.2|75.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||75.000|-19.200|0.2337
71716534|NCT00956384|142947749|SUPERIORITY|A minimally clinically important difference of 4 as statistically significant at the 0.05 level (two-sided), with a power equal to 0.85.|Mean Difference (Final Values)|-2.69||||0.05|TWO_SIDED|95.0|-10.57|5.19||Threshold for statistical significance was p= 0.05|t-test, 2 sided|||For the comparison of mean BREAST-Q subdomain score at each timepoint, Mann-Whitney U test was used for skewed data, while independent t-test was used for not skewed data. We investigated the possibly variable effects of the treatment group differences across multiple time-points, namely 2 weeks after mastectomy, at 6 months and at 12 months following the reconstruction procedure. A linear regression model was used to account for the correlation between the three time-points within each patient||5.19|-10.57|0.05
71716535|NCT00956384|142947750|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|||We assessed the effect of the surgical method on the occurrences of any complications versus none via logistic regression, and results were expressed as odds ratios with 95% CIs.||||<0.05
71716536|NCT00656370|142947755|SUPERIORITY|||||||0.93|||||||Wilcoxon signed rank test|||||||0.93
71716537|NCT00656370|142947756|SUPERIORITY|||||||0.67|||||||Wilcoxon signed rank test|||||||0.67
71716538|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|8.89||||0.6498|TWO_SIDED|95.0|-24.65|42.42||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of C4d score||42.42|-24.65|0.6498
71716539|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|18.56||||0.0768|TWO_SIDED|95.0|1.43|35.68||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of margination score||35.68|1.43|0.0768
71716540|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.0||||0.6928|TWO_SIDED|95.0|-21.36|13.36||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulitis score||13.36|-21.36|0.6928
71716541|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|7.11||||0.0508|TWO_SIDED|95.0|1.23|12.99||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of vasculitis score||12.99|1.23|0.0508
71716542|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-4.89||||0.2042|TWO_SIDED|95.0|-11.34|1.56||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulosclerosis score||1.56|-11.34|0.2042
71716543|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.22||||0.3322|TWO_SIDED|95.0|-0.61|0.17||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic glomerulopathy score||0.17|-0.61|0.3322
71828645|NCT02954848|143161840|SUPERIORITY|||||||0.0811|||||||Log Rank|||||||0.0811
71716544|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|5.67||||0.4723|TWO_SIDED|95.0|-7.77|9.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of interstitial fibrosis score||9.11|-7.77|0.4723
71716545|NCT01147302|142947768|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.56||||0.5103|TWO_SIDED|95.0|-7.25|16.37||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic vasculitis score||16.37|-7.25|0.5103
71716546|NCT01147302|142947769|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.08||||0.7591|TWO_SIDED|95.0|-0.35|0.51||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||0.51|-0.35|0.7591
71716547|NCT01147302|142947769|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.01||||0.9533|TWO_SIDED|95.0|-0.44|0.41||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||0.41|-0.44|0.9533
71716548|NCT01147302|142947770|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.45||||0.9046|TWO_SIDED|95.0|-19.34|22.24||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20||22.24|-19.34|0.9046
71716549|NCT01147302|142947770|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|4.68||||0.5895|TWO_SIDED|95.0|-10.19|19.55||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90||19.55|-10.19|0.5895
71716550|NCT01147302|142947771|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|1.56||||0.4558|TWO_SIDED|90.0|-2.0|5.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 20||5.11|-2.00|0.4558
71716551|NCT01147302|142947771|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.24||||0.947|TWO_SIDED|90.0|-6.05|6.52||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 90||6.52|-6.05|0.9470
71716552|NCT01342094|142947780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||ANCOVA|||||-0.9|-2.2|< 0.001
71716553|NCT02121509|142947781|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.79|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|98.938|106.789|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||106.789|98.938|<0.0001
71716554|NCT02121509|142947781|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.026|<|0.0001|TWO_SIDED|90.0|96.99|106.121|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||106.121|96.990|<0.0001
71828646|NCT02954848|143161841|SUPERIORITY|||||||0.0288|||||||Log Rank|||||||0.0288
71887130|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|94.44|||||TWO_SIDED|90.0|56.44|158.02||||||Buprenorphine||158.02|56.44|
71887131|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|132.57|||||TWO_SIDED|90.0|78.86|222.84||||||Buprenorphine||222.84|78.86|
71887132|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|233.99|||||TWO_SIDED|90.0|135.63|403.68||||||Buprenorphine||403.68|135.63|
71656825|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.74|1.62|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.62|-0.74|
71767907|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.212||0.502|TWO_SIDED|95.0|-0.274|0.558||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.558|-0.274|0.502
71767908|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|1.58|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767909|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.206||0.379|TWO_SIDED|95.0|-0.587|0.224||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.224|-0.587|0.379
71767910|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767911|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.212||0.916|TWO_SIDED|95.0|-0.439|0.394||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.394|-0.439|0.916
71767912|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767913|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.487|TWO_SIDED|95.0|-0.633|0.302||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.302|-0.633|0.487
71828647|NCT02954848|143161842|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.1488|TWO_SIDED|95.0|-0.42|0.04|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response||0.0400|-0.4200|0.1488
71828648|NCT02954848|143161842|SUPERIORITY||Wilcoxon Rank-Sum Test|-0.44||||0.3778|TWO_SIDED|95.0|-1.57|0.69|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response||0.6900|-1.5700|0.3778
71828649|NCT00922207|143161851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.6853|TWO_SIDED|95.0|0.46|1.75|||Cochran-Mantel-Haenszel|||||1.75|0.46|0.6853
71828650|NCT00922207|143161851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1977|TWO_SIDED|95.0|0.35|1.26|||Cochran-Mantel-Haenszel|||||1.26|0.35|0.1977
71887133|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|263.97|||||TWO_SIDED|90.0|155.52|448.03||||||Buprenorphine||448.03|155.52|
71656826|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.04|-1.03|
71656827|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.61|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||0.76|-1.61|
71656828|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.4|||||TWO_SIDED|95.0|-1.52|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||2.39|-1.52|
71656829|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||1.04|-2.30|
71656830|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-2.87|0.74|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.74|-2.87|
71656831|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.55|1.5|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.50|-2.55|
71656832|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.1|||||TWO_SIDED|95.0|-3.06|0.57|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.57|-3.06|
71656833|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.44|1.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||1.00|-2.44|
71656834|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.21|2.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.05|-1.21|
71656835|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.1|||||TWO_SIDED|95.0|-0.52|3.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||3.16|-0.52|
71828651|NCT00922207|143161851|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.2916|TWO_SIDED|95.0|0.39|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.39|0.2916
71716555|NCT02121509|142947782|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.22|STANDARD_ERROR_OF_MEAN|1.046||0.0004|TWO_SIDED|90.0|98.449|114.614|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||114.614|98.449|0.0004
71716556|NCT02121509|142947782|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.71|STANDARD_ERROR_OF_MEAN|1.051||0.004|TWO_SIDED|90.0|97.614|116.658|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||116.658|97.614|0.0040
71716557|NCT02121509|142947783|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.03|STANDARD_ERROR_OF_MEAN|1.05||0.0001|TWO_SIDED|90.0|94.03|110.72|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.72|94.03|0.0001
71716558|NCT02121509|142947783|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|96.36|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|89.96|103.22|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.22|89.96|0.0002
71716559|NCT02121509|142947784|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.1|STANDARD_ERROR_OF_MEAN|1.057||0.0013|TWO_SIDED|90.0|95.829|115.269|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||115.269|95.829|0.0013
71716560|NCT02121509|142947784|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|113.91|STANDARD_ERROR_OF_MEAN|1.027||0.0018|TWO_SIDED|90.0|108.749|119.318|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||119.318|108.749|0.0018
71716561|NCT02121509|142947785|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|90.0|95.748|107.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||107.487|95.748|<0.0001
71716562|NCT02121509|142947785|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|106.33|STANDARD_ERROR_OF_MEAN|1.034||0.0002|TWO_SIDED|90.0|100.268|112.763|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||112.763|100.268|0.0002
71716563|NCT02121509|142947786|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.07|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|90.0|94.2|110.59|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)|||110.59|94.20|<0.0001
71716564|NCT02121509|142947786|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.79|STANDARD_ERROR_OF_MEAN|1.04||0.0001|TWO_SIDED|90.0|90.33|103.7|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 1500 fed/ L+M 1500 fed)|||103.70|90.33|0.0001
71716565|NCT04021290|142947822|NON_INFERIORITY|Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC - CAR) is less than 5%.|Adjusted Difference in Percent (ADP)|-0.8|||||TWO_SIDED|95.0|-2.4|0.8|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor \[PI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and integrase inhibitor \[INI\]).|||0.8|-2.4|
71716566|NCT04021290|142947823|NON_INFERIORITY|Non-inferiority will be concluded if the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms (DTG/3TC-CAR) is greater than -12%.|Adjusted Difference in Percent|1.6|||||TWO_SIDED|95.0|-2.8|5.9|||||ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (PI, NNRTI, and INI).|||5.9|-2.8|
71716567|NCT04021290|142947844|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
71828652|NCT00922207|143161852|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.34||||0.0353|TWO_SIDED|95.0|0.02|0.66|||ANCOVA|||Baseline||0.66|0.02|0.0353
71828653|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.1114|TWO_SIDED|95.0|-0.05|0.52|||ANCOVA|||Baseline||0.52|-0.05|0.1114
71828654|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.515|TWO_SIDED|95.0|-0.42|0.21|||ANCOVA|||Baseline||0.21|-0.42|0.5150
71828655|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|||<|0.001|TWO_SIDED|95.0|0.34|0.89|||ANCOVA|||Change at Week 4||0.89|0.34|<0.001
71828656|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.19|-1.65|||ANCOVA|||Change at Week 4||-1.65|-2.19|<0.001
71828657|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.54|||<|0.001|TWO_SIDED|95.0|-2.81|-2.27|||ANCOVA|||Change at Week 4||-2.27|-2.81|<0.001
71828658|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.001|TWO_SIDED|95.0|1.34|2.06|||ANCOVA|||Change at Week 8||2.06|1.34|<0.001
71656836|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-1.05|2.87|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||2.87|-1.05|
71767914|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767915|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.235||0.963|TWO_SIDED|95.0|-0.451|0.473||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.473|-0.451|0.963
71767916|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767917|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.238||0.856|TWO_SIDED|95.0|-0.424|0.51||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.510|-0.424|0.856
71828659|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55||||0.0071|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Change at Week 8||-0.15|-0.95|0.0071
71828660|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.26|||<|0.001|TWO_SIDED|95.0|-2.61|-1.9|||ANCOVA|||Change at Week 8||-1.90|-2.61|<0.001
71828661|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|1.16|2.08|||ANCOVA|||Change at Week 16||2.08|1.16|<0.001
71828662|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9557|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||Change at Week 16||0.53|-0.56|0.9557
71828663|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.15|-1.14|||ANCOVA|||Change at Week 16||-1.14|-2.15|<0.001
71828664|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.0094|TWO_SIDED|95.0|0.18|1.27|||ANCOVA|||Change at Week 28||1.27|0.18|0.0094
71828665|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.0943|TWO_SIDED|95.0|-0.09|1.11|||ANCOVA|||Change at Week 28||1.11|-0.09|0.0943
71828666|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.4354|TWO_SIDED|95.0|-0.82|0.35|||ANCOVA|||Change at Week 28||0.35|-0.82|0.4354
71828667|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.2509|TWO_SIDED|95.0|-0.26|0.98|||ANCOVA|||Change at Week 40||0.98|-0.26|0.2509
71828668|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.0429|TWO_SIDED|95.0|0.02|1.31|||ANCOVA|||Change at Week 40||1.31|0.02|0.0429
71656837|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.17|2.53|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.53|-0.17|
71656838|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-0.2|2.44|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||2.44|-0.20|
71656839|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.79|1.66|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.66|-1.79|
71656840|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|2.8|||||TWO_SIDED|95.0|-2.85|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-2.85|
71656841|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.9|||||TWO_SIDED|95.0|-9.99|0.21|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.21|-9.99|
71656842|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-7.7|||||TWO_SIDED|95.0|-13.14|-2.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||-2.37|-13.14|
71828669|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.3585|TWO_SIDED|95.0|-0.34|0.93|||ANCOVA|||Change at Week 40||0.93|-0.34|0.3585
71828670|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.9014|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA|||Change at Week 52||0.74|-0.65|0.9014
71828671|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1122|TWO_SIDED|95.0|-0.13|1.28|||ANCOVA|||Change at Week 52||1.28|-0.13|0.1122
71828672|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.1602|TWO_SIDED|95.0|-0.2|1.23|||ANCOVA|||Change at Week 52||1.23|-0.20|0.1602
71828673|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.1599|TWO_SIDED|95.0|-1.17|0.19|||ANCOVA|||Change at Week 64||0.19|-1.17|0.1599
71828674|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.5045|TWO_SIDED|95.0|-0.45|0.92|||ANCOVA|||Change at Week 64||0.92|-0.45|0.5045
71716568|NCT04021290|142947845|OTHER||Adjusted Mean|1.4|||<|0.001|TWO_SIDED|95.0|0.7|2.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||2.2|0.7|<0.001
71716569|NCT04021290|142947846|OTHER||Adjusted Mean|-1.6||||0.021|TWO_SIDED|95.0|-2.9|-0.2|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||-0.2|-2.9|0.021
71716570|NCT04021290|142947847|OTHER||Adjusted Mean|-0.5||||0.398|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model Repeated Measures||MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Age (continuous), Sex, Race, Baseline Value (continuous), Treatment by Visit interaction, Baseline Value by Visit interaction, with Visit as the repeated factor.|||0.7|-1.8|0.398
71716571|NCT00636181|142947849|SUPERIORITY|||||||0.3||||||PSG outcomes employed analysis of variance for approximately normally distributed outcomes (or outcomes that could be transformed to an approximately normal distribution), and the Kruskal-Wallis test for non-normal outcomes.|Kruskal-Wallis|Pairwise differences were determined using Tukey-Kramer test- ANOVA applied or by Mann-Whitney-Wilcoxon summed rank tests and Bonferroni adjustment.||||||0.3
71767918|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767919|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.2|STANDARD_ERROR_OF_MEAN|0.277||0.463|TWO_SIDED|95.0|-0.341|0.748||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.748|-0.341|0.463
71828675|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.0412|TWO_SIDED|95.0|0.03|1.41|||ANCOVA|||Change at Week 64||1.41|0.03|0.0412
71656843|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.84|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.84|-1.00|
71656844|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.27|1.3|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.30|-1.27|
71656845|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.84|1.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.02|-1.84|
71656846|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.08|-1.04|
71656847|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.76|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.76|
71656848|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.83|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.56|-0.83|
71656849|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.47|2.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.09|-0.47|
71656850|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.48|2.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||2.00|-0.48|
71656851|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.59|1.49|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.49|-1.59|
71656852|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.04|1.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.09|-1.04|
71656853|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.05|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.04|-1.05|
71656854|NCT00444457|142831451|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.09|1.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.07|-1.09|
71656855|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.4|||||TWO_SIDED|95.0|-6.52|3.63|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||3.63|-6.52|
71656856|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.7|||||TWO_SIDED|95.0|-11.3|-2.15|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-2.15|-11.30|
71716572|NCT05076045|142947896|SUPERIORITY|||||||0.03||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Results of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in percentage of correct answers between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.03
71716573|NCT05076045|142947897|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|||Null hypothesis is that there was no difference in reaction time between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio as within-subject factors. Participants were included as a random factor.||||0.28
71828676|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.1347|TWO_SIDED|95.0|-1.24|0.17|||ANCOVA|||Change at Week 76||0.17|-1.24|0.1347
71828677|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.4027|TWO_SIDED|95.0|-0.41|1.01|||ANCOVA|||Change at Week 76||1.01|-0.41|0.4027
71716574|NCT05076045|142947898|SUPERIORITY|||||||0.005||||||The threshold for statistical significance was p = 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Quick Speech In Noise score between PSAPs and Control. The performance of the QuickSIN for the two sessions (PSAPs, Control) was compared using the Wilcoxon signed rank test on paired samples.||||0.005
71716575|NCT05076045|142947899|SUPERIORITY|||||||1||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
71716576|NCT05076045|142947900|SUPERIORITY|This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).||||||1|||||||Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||1.00
71716577|NCT05076045|142947901|SUPERIORITY|||||||0.36||||||This p-value has been adjusted using the Bonferroni correction. The threshold for statistical significance was p = 0.05 (two-sided).|Mixed Models Analysis|Result of the pairwise comparisons for the SNR by Session interaction in the linear mixed model analysis.||Null hypothesis is that there was no difference in alpha power between PSAPs and Control. Data were analyzed using a linear mixed-effects (LME) model. The model included session (PSAPs, Control) and signal-to-noise ratio (SNR) as within-subject factors. Participants were included as a random factor.||||0.36
71716578|NCT05076045|142947902|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05 (two-sided).|Cumulative link mixed model|||Null hypothesis is that there was no difference in listening effort between PSAPs and Control. The listening effort score was analyzed using a cumulative link mixed model. A logit link function with flexible thresholds was used. The model included Session (PSAPs, Control) and Block (1, 2, 3) as within-subject factors. Participants were included as a random factor.||||<0.001
71828678|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.0311|TWO_SIDED|95.0|0.07|1.55|||ANCOVA|||Change at Week 76||1.55|0.07|0.0311
71828679|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36||||0.3183|TWO_SIDED|95.0|-1.07|0.35|||ANCOVA|||Change at Week 88||0.35|-1.07|0.3183
71828680|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.1371|TWO_SIDED|95.0|-0.17|1.22|||ANCOVA|||Change at Week 88||1.22|-0.17|0.1371
71656857|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.2|||||TWO_SIDED|95.0|-9.85|-0.79|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4||-0.79|-9.85|
71656858|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.19|2.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||2.07|-1.19|
71716579|NCT03391882|142947903|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|1.722||0.8944|TWO_SIDED|95.0|-3.16|3.62|||Mixed Models Analysis|||||3.62|-3.16|0.8944
71716580|NCT03391882|142947904|SUPERIORITY||Odds Ratio (OR)|1.129||||0.7777|TWO_SIDED|95.0|0.484|2.637|||generalized linear random effects model|||||2.637|0.484|0.7777
71716581|NCT03391882|142947905|SUPERIORITY|||||||0.0002|TWO_SIDED|||||The p-value is from a 1-sample, 2-sided test of the null hypothesis that the true proportion preferring APL is 50% to evaluate if a significantly higher proportion of the subjects prefer APL-130277 or not.|binomial distribution with normal approx|||||||0.0002
71716582|NCT03391882|142947906|SUPERIORITY||Odds Ratio (OR)|1.835||||0.1769|TWO_SIDED|95.0|0.759|4.438|||generalized linear random effects model|||||4.438|0.759|0.1769
71716583|NCT03391882|142947907|SUPERIORITY||Odds Ratio (OR)|1.47||||0.3922|TWO_SIDED|95.0|0.61|3.53|||generalized linear random effects model|||||3.53|0.61|0.3922
71716584|NCT02878382|142947922|SUPERIORITY||||||<|0.001||||||significance level of 5%|Chi-squared|also, Fisher's exact test and Mann-Whtiney were used for comparing the other variables in the study||||||<0.001
71716585|NCT02878382|142947924|SUPERIORITY||||||=|0.001||||||significance level of 5%|Fisher Exact|||||||=0.001
71716586|NCT02878382|142947925|SUPERIORITY||||||=|0.048|||||||Wilcoxon (Mann-Whitney)|||Student's t-test or the Mann-Whitney test was used according to the assumption of normality of data for PpIX fluorescence intensity||||=0.048
71828681|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.0113|TWO_SIDED|95.0|0.21|1.6|||ANCOVA|||Change at Week 88||1.60|0.21|0.0113
71828682|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.5608|TWO_SIDED|95.0|-0.92|0.5|||ANCOVA|||Change at Week 100||0.50|-0.92|0.5608
71828683|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.6323|TWO_SIDED|95.0|-0.53|0.88|||ANCOVA|||Change at Week 100||0.88|-0.53|0.6323
71767920|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71656859|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.69|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||1.06|-1.69|
71656860|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||TWO_SIDED|95.0|-2.27|0.75|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B||0.75|-2.27|
71656861|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.8|||||TWO_SIDED|95.0|-9.46|1.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||1.82|-9.46|
71656862|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.7|||||TWO_SIDED|95.0|-10.24|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||0.76|-10.24|
71656863|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-6.3|4.41|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V||4.41|-6.30|
71656864|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.2|||||TWO_SIDED|95.0|-2.14|1.73|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||1.73|-2.14|
71656865|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-1.69|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.39|-1.69|
71656866|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-1.46|2.59|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14||2.59|-1.46|
71656867|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.5|||||TWO_SIDED|95.0|-11.17|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.20|-11.17|
71656868|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-10.0|||||TWO_SIDED|95.0|-15.31|-4.7|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||-4.70|-15.31|
71656869|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.5|||||TWO_SIDED|95.0|-9.55|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C||0.46|-9.55|
71656870|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||TWO_SIDED|95.0|-4.23|2.52|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||2.52|-4.23|
71656871|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.3|||||TWO_SIDED|95.0|-6.35|-0.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||-0.40|-6.35|
71656872|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.44|0.33|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F||0.33|-5.44|
71656873|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.67|4.8|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||4.80|-3.67|
71656874|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-2.38|6.28|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||6.28|-2.38|
71656875|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.4|||||TWO_SIDED|95.0|-3.06|5.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F||5.82|-3.06|
71656876|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||TWO_SIDED|95.0|-3.34|5.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||5.08|-3.34|
71656877|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.39|1.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||1.18|-6.39|
71656878|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.4|||||TWO_SIDED|95.0|-7.45|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1||0.46|-7.45|
71716587|NCT01634152|142947932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.032||0.2724|TWO_SIDED|95.0|-0.028|0.099|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.099|-0.028|0.2724
71716588|NCT01634152|142947932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.075|0.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.||0.203|0.075|<0.0001
71716589|NCT01634152|142947933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.034||0.5898|TWO_SIDED|95.0|-0.048|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.085|-0.048|0.5898
71716590|NCT01634152|142947933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.034||0.0117|TWO_SIDED|95.0|0.019|0.154|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.||0.154|0.019|0.0117
71716591|NCT01634152|142947934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.036||0.2277|TWO_SIDED|95.0|-0.113|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.027|-0.113|0.2277
71716592|NCT01634152|142947934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.036||0.3998|TWO_SIDED|95.0|-0.04|0.101|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.101|-0.040|0.3998
71716593|NCT01634152|142947935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.037||0.203|TWO_SIDED|95.0|-0.121|0.026|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.026|-0.121|0.2030
71716594|NCT01634152|142947935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.8194|TWO_SIDED|95.0|-0.066|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.066|0.8194
71767921|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.943|TWO_SIDED|95.0|-0.518|0.557||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.557|-0.518|0.943
71767922|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767923|NCT02880956|143037266|SUPERIORITY||LS Mean of Difference|0.74|STANDARD_ERROR_OF_MEAN|0.281||0.009|TWO_SIDED|95.0|0.191|1.295||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||1.295|0.191|0.009
71767924|NCT02880956|143037266|SUPERIORITY||Effect size/pooled SD|-0.38|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71716595|NCT01634152|142947936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031|STANDARD_ERROR_OF_MEAN|0.029||0.2907|TWO_SIDED|95.0|-0.026|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.088|-0.026|0.2907
71716596|NCT01634152|142947936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.068|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.184|0.068|<0.0001
71716597|NCT01634152|142947937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.032||0.2008|TWO_SIDED|95.0|-0.103|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.022|-0.103|0.2008
71716598|NCT01634152|142947937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.032||0.2545|TWO_SIDED|95.0|-0.026|0.1|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.100|-0.026|0.2545
71716599|NCT01634152|142947940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.078||0.798|TWO_SIDED|95.0|-0.133|0.173|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.173|-0.133|0.7980
71716600|NCT01634152|142947940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.079|STANDARD_ERROR_OF_MEAN|0.079||0.3166|TWO_SIDED|95.0|-0.233|0.076|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.076|-0.233|0.3166
71716601|NCT01634152|142947942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.124||0.8916|TWO_SIDED|95.0|-0.227|0.261|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.261|-0.227|0.8916
71716602|NCT01634152|142947942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.126||0.4789|TWO_SIDED|95.0|-0.336|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.158|-0.336|0.4789
71716603|NCT01634152|142947943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.074||0.8361|TWO_SIDED|95.0|-0.16|0.129|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.129|-0.160|0.8361
71828684|NCT00922207|143161852|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2752|TWO_SIDED|95.0|-0.32|1.11|||ANCOVA|||Change at Week 100||1.11|-0.32|0.2752
71716604|NCT01634152|142947943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.087|STANDARD_ERROR_OF_MEAN|0.075||0.2461|TWO_SIDED|95.0|-0.233|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.060|-0.233|0.2461
71716605|NCT01634152|142947944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035|STANDARD_ERROR_OF_MEAN|0.067||0.6029|TWO_SIDED|95.0|-0.096|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.165|-0.096|0.6029
71716606|NCT01634152|142947944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026|STANDARD_ERROR_OF_MEAN|0.067||0.7034|TWO_SIDED|95.0|-0.158|0.107|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.107|-0.158|0.7034
71716607|NCT01634152|142947945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.776|STANDARD_ERROR_OF_MEAN|4.686||0.3083|TWO_SIDED|95.0|-4.419|13.97|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||13.970|-4.419|0.3083
71716608|NCT01634152|142947945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.743|STANDARD_ERROR_OF_MEAN|4.747||0.3179|TWO_SIDED|95.0|-4.571|14.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||14.057|-4.571|0.3179
71716609|NCT01634152|142947946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.567|STANDARD_ERROR_OF_MEAN|4.807||0.9061|TWO_SIDED|95.0|-8.866|10.001|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||10.001|-8.866|0.9061
71767925|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.138||0.325|TWO_SIDED|95.0|-0.408|0.136||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.136|-0.408|0.325
71767926|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767927|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.137||0.966|TWO_SIDED|95.0|-0.274|0.263||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.263|-0.274|0.966
71767928|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767929|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.695|TWO_SIDED|95.0|-0.33|0.22||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.220|-0.330|0.695
71767930|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767931|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.145||0.662|TWO_SIDED|95.0|-0.348|0.221||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.221|-0.348|0.662
71828685|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.6107|TWO_SIDED|95.0|0.26|9.71|||Cochran-Mantel-Haenszel|||Baseline||9.71|0.26|0.6107
71716610|NCT01634152|142947946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.107|STANDARD_ERROR_OF_MEAN|4.867||0.399|TWO_SIDED|95.0|-13.658|5.444|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||5.444|-13.658|0.3990
71716611|NCT01634152|142947947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|1.025||0.3542|TWO_SIDED|95.0|-2.959|1.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||1.060|-2.959|0.3542
71716612|NCT01634152|142947947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.502|STANDARD_ERROR_OF_MEAN|1.042||0.6298|TWO_SIDED|95.0|-2.545|1.541|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||1.541|-2.545|0.6298
71716613|NCT01634152|142947948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.032|STANDARD_ERROR_OF_MEAN|0.038||0.4066|TWO_SIDED|95.0|-0.107|0.043|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.043|-0.107|0.4066
71716614|NCT01634152|142947948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049|STANDARD_ERROR_OF_MEAN|0.039||0.2032|TWO_SIDED|95.0|-0.125|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.027|-0.125|0.2032
71716615|NCT01634152|142947949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051|STANDARD_ERROR_OF_MEAN|0.041||0.2064|TWO_SIDED|95.0|-0.131|0.028|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.028|-0.131|0.2064
71716616|NCT01634152|142947949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.061|STANDARD_ERROR_OF_MEAN|0.041||0.141|TWO_SIDED|95.0|-0.142|0.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.020|-0.142|0.1410
71716617|NCT01634152|142947950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.042||0.9869|TWO_SIDED|95.0|-0.083|0.082|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.082|-0.083|0.9869
71716618|NCT01634152|142947950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.043||0.873|TWO_SIDED|95.0|-0.077|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.077|0.8730
71716619|NCT01634152|142947951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.006|STANDARD_ERROR_OF_MEAN|0.049||0.9043|TWO_SIDED|95.0|-0.103|0.091|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.091|-0.103|0.9043
71716620|NCT01634152|142947951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.05||0.7708|TWO_SIDED|95.0|-0.112|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.083|-0.112|0.7708
71716621|NCT01634152|142947952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.4864|TWO_SIDED|95.0|-0.139|0.066|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.066|-0.139|0.4864
71716622|NCT01634152|142947952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.053||0.7991|TWO_SIDED|95.0|-0.117|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.090|-0.117|0.7991
71716623|NCT01634152|142947953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.05||0.8884|TWO_SIDED|95.0|-0.092|0.106|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.106|-0.092|0.8884
71716624|NCT01634152|142947953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.051||0.8115|TWO_SIDED|95.0|-0.112|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.088|-0.112|0.8115
71716625|NCT01634152|142947954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.051||0.7498|TWO_SIDED|95.0|-0.084|0.117|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.117|-0.084|0.7498
71716626|NCT01634152|142947954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|STANDARD_ERROR_OF_MEAN|0.052||0.1108|TWO_SIDED|95.0|-0.185|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.019|-0.185|0.1108
71828686|NCT00922207|143161853|SUPERIORITY_OR_OTHER|||||||0.0788|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.0788
71828687|NCT00922207|143161853|SUPERIORITY_OR_OTHER|||||||0.1761|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.1761
71716627|NCT01634152|142947955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.059||0.8055|TWO_SIDED|95.0|-0.131|0.102|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.102|-0.131|0.8055
71828688|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.7044|TWO_SIDED|95.0|0.34|5.09|||Cochran-Mantel-Haenszel|||Week 4||5.09|0.34|0.7044
71828689|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.35||||0.0927|TWO_SIDED|95.0|0.61|46.76|||Cochran-Mantel-Haenszel|||Week 4||46.76|0.61|0.0927
71716628|NCT01634152|142947955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.071|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.189|0.047|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.047|-0.189|0.2360
71716629|NCT01634152|142947956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|STANDARD_ERROR_OF_MEAN|0.041||0.6748|TWO_SIDED|95.0|-0.097|0.063|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|||0.063|-0.097|0.6748
71716630|NCT01634152|142947956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025|STANDARD_ERROR_OF_MEAN|0.041||0.5497|TWO_SIDED|95.0|-0.056|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|||0.105|-0.056|0.5497
71716631|NCT01482715|142947958|OTHER||RP2D|600.0|||||TWO_SIDED||||||||||A MTD was not established based on observation of DLTs in Cycle 1 of treatment. The 600 mg BID dose was considered to be the maximum dose with an acceptable toxicity profile that could be continuously administered to patients and was selected as the recommended Phase 2 dose (RP2D).|||
71716632|NCT01152437|142947981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.122||||0.0735|TWO_SIDED|90.0|0.018|0.844||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Regression, Logistic|Wald Chi-square test and Confidence Interval from logistic regression stratified by number of lines of palliative chemotherapy.||Null hypothesis is that the objective response rate (ORR) in KRAS wild-type patients treated with afatinib is less than or equal to the ORR in KRAS wild-type patients treated with cetuximab. Sample size is based on a 'pick the winner' approach assuming ORR for cetuximab of 12%, undesirable ORR for afatinib of 11% and desirable ORR for afatinib of 16%. As per 'pick the winner' approach, afatinib would be considered 'the winner' if the ORR for afatinib was greater than the ORR for cetuximab.||0.844|0.018|0.0735
71716633|NCT01152437|142947982|SUPERIORITY_OR_OTHER||Percentage of participants|12.0||||0.6394|TWO_SIDED|90.0|4.9|23.9||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Exact binomial test|||Null hypothesis is that the disease control rate is 10% in patients with KRAS mutation. Sample size calculation based on a 2-sided exact binomial test at 10% significance level to distinguish between the historical disease control rate of 10% and a desirable disease control rate for afatinib of 25%.||23.9|4.9|0.6394
71716634|NCT00279214|142947986|SUPERIORITY_OR_OTHER|||||||0.238||95.0|||||Repeated Measures - propensity adjusted|||24-Hour p-value||||0.238
71716635|NCT00279214|142947986|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.281
71716636|NCT00279214|142947987|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||P-value for 96 Hour Change from Baseline.|Mixed Models Analysis|Model: Outcome=Therapy + Sedative Indicator + Time + Therapy\*Time + Propensity Score||||||0.478
71716637|NCT00279214|142947988|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.442
71716638|NCT00279214|142947988|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.871
71716639|NCT00279214|142947989|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.704
71828690|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04||||0.1858|TWO_SIDED|95.0|0.44|36.89|||Cochran-Mantel-Haenszel|||Week 4||36.89|0.44|0.1858
71828691|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9385|TWO_SIDED|95.0|0.33|3.38|||Cochran-Mantel-Haenszel|||Week 8||3.38|0.33|0.9385
71828692|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5068|TWO_SIDED|95.0|0.43|5.77|||Cochran-Mantel-Haenszel|||Week 8||5.77|0.43|0.5068
71828693|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.5544|TWO_SIDED|95.0|0.41|5.5|||Cochran-Mantel-Haenszel|||Week 8||5.50|0.41|0.5544
71716640|NCT00279214|142947989|SUPERIORITY_OR_OTHER|||||||0.702||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.702
71716641|NCT00279214|142947990|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||6-Hour p-value|Repeated Measures - propensity adjusted|||||||0.061
71716642|NCT00279214|142947990|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||6-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.027
71716643|NCT00279214|142947991|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.242
71716644|NCT00279214|142947991|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.083
71716645|NCT00279214|142947991|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.810
71716646|NCT00279214|142947991|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.623
71716647|NCT00279214|142947992|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.686
71716648|NCT00279214|142947992|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.575
71716649|NCT00279214|142947993|SUPERIORITY_OR_OTHER|||||||0.165||95.0|||||Repeated Measures - propensity adjusted|||||||0.165
71828694|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.651|TWO_SIDED|95.0|0.26|2.31|||Cochran-Mantel-Haenszel|||Week 16||2.31|0.26|0.6510
71828695|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.3192|TWO_SIDED|95.0|0.2|1.69|||Cochran-Mantel-Haenszel|||Week 16||1.69|0.20|0.3192
71828696|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|2.03|||Cochran-Mantel-Haenszel|||Week 16||2.03|0.29|0.5818
71716650|NCT00279214|142947995|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||Baseline p-value|Repeated Measures - propensity adjusted|||||||0.552
71716651|NCT00279214|142947995|SUPERIORITY_OR_OTHER|||||||0.129||95.0||||12-Hour p-value|Repeated Measures - propensity adjusted|||||||0.129
71716652|NCT00279214|142947995|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.030
71716653|NCT00279214|142947995|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.002
71716654|NCT00279214|142947997|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||24-Hour p-value|Repeated Measures - propensity adjusted|||||||0.128
71716655|NCT00279214|142947997|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted|||||||0.234
71716656|NCT01214837|142947999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-7.0|||||TWO_SIDED|95.0|-14.0|-1.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.||-1|-14|
71716657|NCT01214837|142947999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-8.0|0.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.||0|-8|
71716658|NCT01214837|142947999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.||3|-3|
71716659|NCT01214837|142947999|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.||4|-2|
71716660|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.5|||||TWO_SIDED|95.0|-6.1|5.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||5|-6.1|
71716661|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.8|||||TWO_SIDED|95.0|3.0|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.||10.5|3|
71767932|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828697|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8796|TWO_SIDED|95.0|0.41|2.66|||Cochran-Mantel-Haenszel|||Week 28||2.66|0.41|0.8796
71828698|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.305|TWO_SIDED|95.0|0.27|1.52|||Cochran-Mantel-Haenszel|||Week 28||1.52|0.27|0.3050
71828699|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.2414|TWO_SIDED|95.0|0.26|1.44|||Cochran-Mantel-Haenszel|||Week 28||1.44|0.26|0.2414
71767933|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.141||0.849|TWO_SIDED|95.0|-0.25|0.304||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.304|-0.250|0.849
71767934|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|1.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767935|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.145||0.995|TWO_SIDED|95.0|-0.286|0.284||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.284|-0.286|0.995
71828700|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8502|TWO_SIDED|95.0|0.5|2.22|||Cochran-Mantel-Haenszel|||Week 40||2.22|0.50|0.8502
71716662|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-11.9|6.0|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||6|-11.9|
71716663|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.3|||||TWO_SIDED|95.0|-3.3|13.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.||13.7|-3.3|
71716664|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.4|||||TWO_SIDED|95.0|-7.5|2.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||2.3|-7.5|
71716665|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.3|||||TWO_SIDED|95.0|-4.4|4.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.||4.7|-4.4|
71716666|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||3.4|-12.1|
71716667|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.9|||||TWO_SIDED|95.0|-1.9|11.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.||11.8|-1.9|
71716668|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.04|||||TWO_SIDED|95.0|-3.7|3.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||3.8|-3.7|
71767936|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767937|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.707|TWO_SIDED|95.0|-0.256|0.378||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.378|-0.256|0.707
71767938|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767939|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.159||0.901|TWO_SIDED|95.0|-0.294|0.333||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.333|-0.294|0.901
71828701|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.5|TWO_SIDED|95.0|0.38|1.61|||Cochran-Mantel-Haenszel|||Week 40||1.61|0.38|0.5000
71716669|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.2|||||TWO_SIDED|95.0|-2.2|4.8|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.||4.8|-2.2|
71716670|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.3|||||TWO_SIDED|95.0|-8.4|7.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||7.7|-8.4|
71716671|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|10.2|||||TWO_SIDED|95.0|3.4|17.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.||17.2|3.4|
71767940|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767941|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.451|TWO_SIDED|95.0|-0.195|0.439||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.439|-0.195|0.451
71767942|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767943|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.185||0.722|TWO_SIDED|95.0|-0.429|0.298||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.298|-0.429|0.722
71767944|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767945|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.181||0.42|TWO_SIDED|95.0|-0.503|0.21||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.210|-0.503|0.420
71828702|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3882|TWO_SIDED|95.0|0.36|1.53|||Cochran-Mantel-Haenszel|||Week 40||1.53|0.36|0.3882
71828703|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9584|TWO_SIDED|95.0|0.5|1.99|||Cochran-Mantel-Haenszel|||Week 52||1.99|0.50|0.9584
71828704|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2576|TWO_SIDED|95.0|0.35|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.35|0.2576
71828705|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2362|TWO_SIDED|95.0|0.36|1.34|||Cochran-Mantel-Haenszel|||Week 52||1.34|0.36|0.2362
71828706|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9861|TWO_SIDED|95.0|0.49|1.9|||Cochran-Mantel-Haenszel|||Week 64||1.90|0.49|0.9861
71828707|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2919|TWO_SIDED|95.0|0.37|1.35|||Cochran-Mantel-Haenszel|||Week 64||1.35|0.37|0.2919
71887134|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|159.38|||||TWO_SIDED|90.0|78.21|324.79||||||Norbuprenorphine||324.79|78.21|
71767946|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767947|NCT02880956|143037267|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.187||0.498|TWO_SIDED|95.0|-0.495|0.241||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.241|-0.495|0.498
71767948|NCT02880956|143037267|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828708|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2674|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 64||1.38|0.38|0.2674
71828709|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6148|TWO_SIDED|95.0|0.43|1.64|||Cochran-Mantel-Haenszel|||Week 76||1.64|0.43|0.6148
71828710|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.0904|TWO_SIDED|95.0|0.3|1.08|||Cochran-Mantel-Haenszel|||Week 76||1.08|0.30|0.0904
71828711|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2073|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 76||1.27|0.36|0.2073
71828712|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.998|TWO_SIDED|95.0|0.52|1.98|||Cochran-Mantel-Haenszel|||Week 88||1.98|0.52|0.9980
71828713|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.3489|TWO_SIDED|95.0|0.39|1.4|||Cochran-Mantel-Haenszel|||Week 88||1.40|0.39|0.3489
71887135|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|106.93|||||TWO_SIDED|90.0|52.47|217.91||||||Norbuprenorphine||217.91|52.47|
71716672|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-1.7|
71716673|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.||3.5|-2.1|
71716674|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.1|||||TWO_SIDED|95.0|-9.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||3.4|-9.7|
71716675|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.5|9.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.||9.7|-1.5|
71716676|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|vaccine group difference|1.9|||||TWO_SIDED|95.0|-1.2|5.7|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||5.7|-1.2|
71716677|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|2.5|||||TWO_SIDED|95.0|-0.2|6.3|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.||6.3|-0.2|
71716678|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-6.3|-0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||-0.2|-6.3|
71767949|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.071||0.975|TWO_SIDED|95.0|-0.138|0.142||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.142|-0.138|0.975
71828714|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.2847|TWO_SIDED|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 88||1.38|0.38|0.2847
71828715|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5596|TWO_SIDED|95.0|0.44|1.62|||Cochran-Mantel-Haenszel|||Week 100||1.62|0.44|0.5596
71716679|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.2|||||TWO_SIDED|95.0|-6.2|0.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.||0.2|-6.2|
71828716|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.2112|TWO_SIDED|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 100||1.27|0.36|0.2112
71828717|NCT00922207|143161853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4066|TWO_SIDED|95.0|0.43|1.48|||Cochran-Mantel-Haenszel|||Week 100||1.48|0.43|0.4066
71828718|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.6921|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6921
71828719|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.3939|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.3939
71828720|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.6818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Baseline||||0.6818
71828721|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.7582|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7582
71828722|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.5381|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.5381
71828723|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6||||0.7747
71828724|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.8034
71716680|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||TWO_SIDED|95.0|-7.1|1.6|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||1.6|-7.1|
71716681|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-5.5|||||TWO_SIDED|95.0|-11.3|-0.9|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.||-0.9|-11.3|
71716682|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-1.7|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-1.7|
71716683|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||TWO_SIDED|95.0|-2.1|3.4|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.||3.4|-2.1|
71828725|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6306|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.6306
71828726|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.4574|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12||||0.4574
71716684|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.9|||||TWO_SIDED|95.0|-4.2|8.2|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||8.2|-4.2|
71716685|NCT01214837|142948006|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.5|||||TWO_SIDED|95.0|-1.4|10.5|||Miettinen and Nurminen method|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.||10.5|-1.4|
71828727|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5824|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5824
71828728|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9321|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.9321
71828729|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.5263|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16||||0.5263
71767950|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828730|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.2025|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Week 22||||0.2025
71828731|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6702|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.6702
71828732|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 22||||0.0818
71828733|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6214|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6214
71828734|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6774|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.6774
71828735|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3154|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 28||||0.3154
71828736|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2709|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.2709
71828737|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.3804|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.3804
71828738|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7645|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 34||||0.7645
71828739|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.182|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.1820
71828740|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.7167|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.7167
71716686|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.13|0.77|
71716687|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.||1.25|0.83|
71716688|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.14|||||TWO_SIDED|95.0|0.93|1.4|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.4|0.93|
71716689|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.25|||||TWO_SIDED|95.0|1.01|1.55|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.||1.55|1.01|
71716690|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||0.96|0.62|
71716691|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.||1.18|0.75|
71716692|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.21|0.86|
71828741|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.3104|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 40||||0.3104
71828742|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.091|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.0910
71828743|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6094|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.6094
71828744|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2166|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 46||||0.2166
71828745|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.901|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9010
71828746|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.9060
71716693|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5|GMC ratio|1.07|||||TWO_SIDED|95.0|0.89|1.29|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.||1.29|0.89|
71716694|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.04|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.04|0.69|
71716695|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.88|1.37|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.||1.37|0.88|
71828747|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 52||||0.7268
71828748|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.5372|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.5372
71828749|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1588|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.1588
71828750|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.4268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 64||||0.4268
71828751|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.4389|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.4389
71828752|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.6708|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.6708
71828753|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.2145|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 76||||0.2145
71828754|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.8608|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.8608
71716696|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.05|0.69|
71716697|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.||1.3|0.83|
71716698|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||0.95|0.67|
71716699|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.||1.25|0.87|
71716700|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.66|0.96|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||0.96|0.66|
71716701|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.||1.31|0.87|
71716702|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.27|0.84|
71716703|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.||1.3|0.83|
71716704|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||0.87|0.59|
71716705|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.89|1.36|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.||1.36|0.89|
71716706|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.83|1.27|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.27|0.83|
71716707|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.77|1.21|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.||1.21|0.77|
71767951|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.078|TWO_SIDED|95.0|-0.014|0.261||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.261|-0.014|0.078
71716708|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.22|0.82|
71828755|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.0283|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0283
71767952|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|0.66|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767953|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.072||0.514|TWO_SIDED|95.0|-0.188|0.094||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.094|-0.188|0.514
71767954|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|0.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767955|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.102||0.107|TWO_SIDED|95.0|-0.367|0.036||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.036|-0.367|0.107
71767956|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767957|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.099||0.425|TWO_SIDED|95.0|-0.275|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.116|-0.275|0.425
71767958|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767959|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.102||0.039|TWO_SIDED|95.0|-0.413|-0.011||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||-0.011|-0.413|0.039
71828756|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.0369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 88||||0.0369
71767960|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.28|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767961|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.729|TWO_SIDED|95.0|-0.302|0.212||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.212|-0.302|0.729
71767962|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767963|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.128||0.671|TWO_SIDED|95.0|-0.198|0.307||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.307|-0.198|0.671
71767964|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71828757|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4606|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.4606
71828758|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.0832|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.0832
71767965|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.876|TWO_SIDED|95.0|-0.235|0.276||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.276|-0.235|0.876
71767966|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767967|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.159||0.763|TWO_SIDED|95.0|-0.266|0.362||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.362|-0.266|0.763
71767968|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767969|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.157||0.429|TWO_SIDED|95.0|-0.434|0.185||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.185|-0.434|0.429
71767970|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|1.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828759|NCT00922207|143161855|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2655|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 100||||0.2655
71828760|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0649|TWO_SIDED|95.0|-0.01|0.43|||ANCOVA|||Baseline||0.43|-0.01|0.0649
71828761|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1867|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||Baseline||0.33|-0.06|0.1867
71828762|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.5003|TWO_SIDED|95.0|-0.3|0.15|||ANCOVA|||Baseline||0.15|-0.30|0.5003
71716709|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.86|1.32|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.||1.32|0.86|
71716710|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||TWO_SIDED|95.0|0.62|0.97|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||0.97|0.62|
71716711|NCT01214837|142948007|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13|||ANOVA|||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.||1.13|0.7|
71716712|NCT00269113|142948047|SUPERIORITY_OR_OTHER||Difference in percentage of participants|17.4||||0.0009|TWO_SIDED|95.0|6.4|28.4|||Fisher Exact|||||28.4|6.4|0.0009
71716713|NCT00269113|142948048|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71716714|NCT00269113|142948049|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Log Rank|||||||0.0127
71716715|NCT00269113|142948050|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71716716|NCT00269113|142948051|SUPERIORITY_OR_OTHER|||||||0.0186|||||||Log Rank|||||||0.0186
71716717|NCT00269113|142948052|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Log Rank|||||||0.0002
71716718|NCT00269113|142948053|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Log Rank|||||||0.0017
71716719|NCT01714323|142948054|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||>|0.05|TWO_SIDED|95.0|0.84|1.37|||Chi-squared|||Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.||1.37|0.84|>0.05
71716720|NCT01714323|142948055|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71716721|NCT01714323|142948056|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This compares at Month 1||||<0.001
71716722|NCT01714323|142948056|SUPERIORITY||||||<|0.01|||||||Chi-squared|||This is analysis for Month 3||||<0.01
71716723|NCT01714323|142948056|SUPERIORITY||||||<|0.09|||||||Chi-squared|||This is for Month 6||||<0.09
71716724|NCT01714323|142948058|SUPERIORITY_OR_OTHER||||||<|0.001||||||This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.|Chi-squared|||||||<0.001
71716725|NCT01714323|142948059|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71716726|NCT01714323|142948060|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71716727|NCT00755807|142948061|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week,participant random effect.||Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.||||0.001
71716728|NCT00755807|142948062|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.027
71716729|NCT00755807|142948062|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.246
71716730|NCT00755807|142948062|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.024
71716731|NCT00755807|142948062|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.165
71716732|NCT00755807|142948063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.121|TWO_SIDED|95.0|-0.06|0.49||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.|The mean difference is for placebo - duloxetine.|||0.49|-0.06|0.121
71716733|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.016|TWO_SIDED|95.0|0.12|1.2||P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.20|0.12|0.016
71716734|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95||P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.95|0.02|0.043
71716735|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.05|0.99||P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.99|0.05|0.030
71767971|NCT02880956|143037268|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.162||0.701|TWO_SIDED|95.0|-0.256|0.381||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 96||0.381|-0.256|0.701
71716736|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.001|TWO_SIDED|95.0|0.36|1.43||P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.43|0.36|0.001
71716737|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.083|TWO_SIDED|95.0|-0.07|1.11||P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.11|-0.07|0.083
71716738|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.034|TWO_SIDED|95.0|0.05|1.27||P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.27|0.05|0.034
71716739|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.089|TWO_SIDED|95.0|-0.08|1.19||P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.19|-0.08|0.089
71767972|NCT02880956|143037268|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|1.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767973|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.064||0.867|TWO_SIDED|95.0|-0.115|0.137||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.137|-0.115|0.867
71767974|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767975|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063||0.898|TWO_SIDED|95.0|-0.132|0.116||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.116|-0.132|0.898
71767976|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767977|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.065||0.537|TWO_SIDED|95.0|-0.088|0.168||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 24||0.168|-0.088|0.537
71767978|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71716740|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.291|TWO_SIDED|95.0|-0.28|0.93||P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.93|-0.28|0.291
71716741|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.077|TWO_SIDED|95.0|-0.06|1.05||P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.05|-0.06|0.077
71716742|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.148|TWO_SIDED|95.0|-0.15|0.97||P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.97|-0.15|0.148
71767979|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.074||0.176|TWO_SIDED|95.0|-0.245|0.045||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.045|-0.245|0.176
71767980|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|0.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828763|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.2259|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 4||0.05|-0.22|0.2259
71828764|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4||-0.11|-0.36|<0.001
71828765|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.0085|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Change at Week 4||-0.04|-0.27|0.0085
71828766|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.816|TWO_SIDED|95.0|-0.22|0.18|||ANCOVA|||Change at Week 8||0.18|-0.22|0.8160
71828767|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.4393|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Change at Week 8||0.12|-0.27|0.4393
71828768|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.489|TWO_SIDED|95.0|-0.22|0.11|||ANCOVA|||Change at Week 8||0.11|-0.22|0.4890
71828769|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.4656|TWO_SIDED|95.0|-0.14|0.3|||ANCOVA|||Change at Week 16||0.30|-0.14|0.4656
71828770|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.5016|TWO_SIDED|95.0|-0.15|0.31|||ANCOVA|||Change at Week 16||0.31|-0.15|0.5016
71716743|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.582|TWO_SIDED|95.0|-0.45|0.79||P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-0.45|0.582
71716744|NCT00755807|142948064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.067|TWO_SIDED|95.0|-0.03|0.94||P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.94|-0.03|0.067
71716745|NCT00755807|142948065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.041|TWO_SIDED|95.0|0.01|0.45||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.45|0.01|0.041
71716746|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5|TWO_SIDED|95.0|-3.9|1.91||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.91|-3.90|0.500
71716747|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.512|TWO_SIDED|95.0|-4.87|2.44||P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.44|-4.87|0.512
71716748|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.72|TWO_SIDED|95.0|-4.51|3.12||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.12|-4.51|0.720
71716749|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.973|TWO_SIDED|95.0|-3.58|3.46||P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||3.46|-3.58|0.973
71716750|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.991|TWO_SIDED|95.0|-4.07|4.02||P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.02|-4.07|0.991
71716751|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14||||0.441|TWO_SIDED|95.0|-11.14|4.87||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-11.14|0.441
71828771|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.9582|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Change at Week 16||0.22|-0.23|0.9582
71716752|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.108|TWO_SIDED|95.0|-7.94|0.79||P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.79|-7.94|0.108
71716753|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.948|TWO_SIDED|95.0|-5.77|5.39||P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.39|-5.77|0.948
71716754|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96||||0.374|TWO_SIDED|95.0|-2.37|6.28||P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||6.28|-2.37|0.374
71716755|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.867|TWO_SIDED|95.0|-4.1|4.87||P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.87|-4.10|0.867
71716756|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77||||0.306|TWO_SIDED|95.0|-1.63|5.17||P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||5.17|-1.63|0.306
71716757|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.733|TWO_SIDED|95.0|-4.08|2.88||P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.88|-4.08|0.733
71828772|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.6214|TWO_SIDED|95.0|-0.21|0.36|||ANCOVA|||Change at Week 28||0.36|-0.21|0.6214
71716758|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.283|TWO_SIDED|95.0|-13.88|4.08||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||4.08|-13.88|0.283
71716759|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.664|TWO_SIDED|95.0|-4.49|2.86||P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.86|-4.49|0.664
71716760|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98||||0.504|TWO_SIDED|95.0|-7.81|3.85||P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.85|-7.81|0.504
71716761|NCT00755807|142948066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.27|TWO_SIDED|95.0|-11.18|3.14||P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine|||3.14|-11.18|0.270
71716762|NCT00755807|142948067|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.119
71716763|NCT00755807|142948067|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
71716764|NCT00755807|142948067|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.494
71716765|NCT00755807|142948068|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment\*Week+Baseline\*Week; participant=random effect.||||||0.002
71716766|NCT00755807|142948069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.662|TWO_SIDED|95.0|-0.06|0.04||P-value is for treatment comparison of change from baseline on BDI-II Question #9 score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.04|-0.06|0.662
71828773|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.5493|TWO_SIDED|95.0|-0.21|0.39|||ANCOVA|||Change at Week 28||0.39|-0.21|0.5493
71716767|NCT00755807|142948070|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||This is the P-value for Discontinuation Due to Any Reason.|Fisher Exact|||||||0.244
71716768|NCT00755807|142948070|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||This is the P-value for Adverse Event (AE).|Fisher Exact|||||||0.012
71716769|NCT00755807|142948070|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||This is the P-value for Protocol Violation.|Fisher Exact|||||||0.622
71716770|NCT00755807|142948070|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Subject Decision.|Fisher Exact|||||||1.00
71716771|NCT00755807|142948070|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Lack of Efficacy.|Fisher Exact|||||||1.00
71716772|NCT00755807|142948070|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the P-value for Physician Decision.|Fisher Exact|||||||1.00
71716773|NCT00755807|142948073|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for treatment comparison of change from baseline on Bicarbonate, HCO3. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.047
71716774|NCT00755807|142948074|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value is for treatment comparison of change from baseline on creatinine. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.033
71716775|NCT00755807|142948075|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for treatment comparison of change from baseline on platelet count. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from baseline = Treatment + Investigator.||||||0.034
71716776|NCT00755807|142948076|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value is for treatment comparison of change from baseline on inorganic phosphorus. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.007
71716777|NCT00755807|142948077|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for treatment comparison of change from baseline on uric acid. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.||||||0.025
71716778|NCT00755807|142948078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.322|TWO_SIDED|95.0|-2.55|0.84||P-value is for treatment comparison of change from baseline on diastolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.84|-2.55|0.322
71828774|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.8881|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 28||0.32|-0.28|0.8881
71828775|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7912|TWO_SIDED|95.0|-0.36|0.27|||ANCOVA|||Change at Week 40||0.27|-0.36|0.7912
71716779|NCT00755807|142948078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.787|TWO_SIDED|95.0|-3.32|2.52||P-value is for treatment comparison of change from baseline on systolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||2.52|-3.32|0.787
71716780|NCT00755807|142948079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.16|TWO_SIDED|95.0|-3.7|0.61||P-value is for treatment comparison of change from baseline on pulse rate. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||0.61|-3.70|0.160
71716781|NCT00755807|142948080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.003|TWO_SIDED|95.0|0.27|1.26||P-value is for treatment comparison of change from baseline on weight. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.|||1.26|0.27|0.003
71716782|NCT00755807|142948081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean PGI-I score at 18 weeks for all participants who entered extension phase.||||||<0.001
71828776|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.5427|TWO_SIDED|95.0|-0.24|0.46|||ANCOVA|||Change at Week 40||0.46|-0.24|0.5427
71828777|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3788|TWO_SIDED|95.0|-0.19|0.49|||ANCOVA|||Change at Week 40||0.49|-0.19|0.3788
71828778|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.6172|TWO_SIDED|95.0|-0.44|0.26|||ANCOVA|||Change at Week 52||0.26|-0.44|0.6172
71716783|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Worst Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.||||||<0.001
71716784|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.||||||<0.001
71716785|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.||||||<0.001
71716786|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.||||||<0.001
71716787|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.||||||<0.001
71828779|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6002|TWO_SIDED|95.0|-0.29|0.5|||ANCOVA|||Change at Week 52||0.50|-0.29|0.6002
71716788|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.||||||<0.001
71716789|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.||||||<0.001
71716790|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.||||||<0.001
71716791|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.||||||<0.001
71716792|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.||||||<0.001
71716793|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.||||||<0.001
71716794|NCT00755807|142948082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.||||||<0.001
71828780|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.3101|TWO_SIDED|95.0|-0.18|0.56|||ANCOVA|||Change at Week 52||0.56|-0.18|0.3101
71828781|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.4256|TWO_SIDED|95.0|-0.47|0.2|||ANCOVA|||Change at Week 64||0.20|-0.47|0.4256
71828782|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.9762|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||Change at Week 64||0.36|-0.35|0.9762
71828783|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.4504|TWO_SIDED|95.0|-0.21|0.47|||ANCOVA|||Change at Week 64||0.47|-0.21|0.4504
71716795|NCT00755807|142948083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.||||||<0.001
71716796|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.||||||0.002
71716797|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.||||||0.054
71716798|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.||||||0.002
71716799|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.||||||0.025
71716800|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.||||||0.008
71716801|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.||||||0.858
71716802|NCT00755807|142948084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.||||||<0.001
71716803|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.||||||0.637
71716804|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.||||||0.051
71716805|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.||||||0.270
71716806|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.||||||0.061
71716807|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.||||||0.007
71716808|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.||||||0.253
71716809|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.942||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.||||||0.942
71716810|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.||||||0.016
71716811|NCT00755807|142948084|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.||||||0.381
71716812|NCT00755807|142948086|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline\*Week; participant was treated as random effect.||||||0.524
71716813|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71828784|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.4076|TWO_SIDED|95.0|-0.42|0.17|||ANCOVA|||Change at Week 76||0.17|-0.42|0.4076
71828785|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7591|TWO_SIDED|95.0|-0.37|0.27|||ANCOVA|||Change at Week 76||0.27|-0.37|0.7591
71828786|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.6449|TWO_SIDED|95.0|-0.25|0.4|||ANCOVA|||Change at Week 76||0.40|-0.25|0.6449
71828787|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.7108|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||Change at Week 88||0.25|-0.36|0.7108
71828788|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.4725|TWO_SIDED|95.0|-0.22|0.47|||ANCOVA|||Change at Week 88||0.47|-0.22|0.4725
71767981|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.072||0.125|TWO_SIDED|95.0|-0.251|0.031||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 48||0.031|-0.251|0.125
71767982|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|0.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767983|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.074||0.676|TWO_SIDED|95.0|-0.176|0.114||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||week 48||0.114|-0.176|0.676
71767984|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71767985|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.226|TWO_SIDED|95.0|-0.301|0.071||"The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit~\+ baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured."|repeated measures model|||Week 72||0.071|-0.301|0.226
71828789|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.2439|TWO_SIDED|95.0|-0.13|0.5|||ANCOVA|||Change at Week 88||0.50|-0.13|0.2439
71828790|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.1862|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Change at Week 100||0.50|-0.10|0.1862
71828791|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.3057|TWO_SIDED|95.0|-0.14|0.43|||ANCOVA|||Change at Week 100||0.43|-0.14|0.3057
71828792|NCT00922207|143161856|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.8002|TWO_SIDED|95.0|-0.38|0.29|||ANCOVA|||Change at Week 100||0.29|-0.38|0.8002
71828793|NCT02326649|143161864|OTHER|||||||0.47|||||||paired t-test|||||||0.47
71828794|NCT02326649|143161864|OTHER||Mean Difference (Final Values)|6.561|STANDARD_ERROR_OF_MEAN|5.528||0.255|TWO_SIDED|95.0|-5.295|18.417|||Regression, Linear|||Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||18.417|-5.295|0.255
71828795|NCT02326649|143161864|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.417||0.25|TWO_SIDED|95.0|-0.395|1.395|||Regression, Linear|||Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.395|-0.395|0.250
71828796|NCT02326649|143161864|OTHER||Mean Difference (Final Values)|-0.427|STANDARD_ERROR_OF_MEAN|0.305||0.183|TWO_SIDED|95.0|-1.081|0.227|||Regression, Linear|||Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||0.227|-1.081|0.183
71828797|NCT02326649|143161864|OTHER||Mean Difference (Final Values)|0.557|STANDARD_ERROR_OF_MEAN|0.452||0.238|TWO_SIDED|95.0|-0.411|1.526|||Regression, Linear|||Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure||1.526|-0.411|0.238
71828798|NCT03698708|143161867|SUPERIORITY||cohen's d|0.88|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71828799|NCT03698708|143161868|SUPERIORITY||cohen's d|0.22|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71828800|NCT03698708|143161869|SUPERIORITY||cohen's d|0.05|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71767986|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767987|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.093||0.683|TWO_SIDED|95.0|-0.222|0.145||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.145|-0.222|0.683
71767988|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71767989|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.094||0.848|TWO_SIDED|95.0|-0.168|0.204||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.204|-0.168|0.848
71767990|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|0.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71828801|NCT03698708|143161870|SUPERIORITY||cohen's d|0.14|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71828802|NCT03698708|143161871|SUPERIORITY||cohen's d|0.09|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71828803|NCT03698708|143161872|SUPERIORITY||Mean Difference (Final Values)|-4.16|||||TWO_SIDED|95.0|-10.07|1.74|||ANOVA|||||1.74|-10.07|
71828804|NCT03495713|143161873|OTHER||||||||||||||||||Descriptive analysis only based limited enrollments.|||
71828805|NCT04001517|143161877|SUPERIORITY||Mean Difference (Net)|0.175||||0.049|TWO_SIDED|95.0|0.001|0.345||The comparison is of neflamapimod 40mg TID to placebo. The p-value was not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. The positive value represents a better outcome with neflamapimod 40mg treatment vs. placebo.|This was an exploratory trial and no explicit a priori hypothesis was established and contained in the protocol. As such, no formal power calculations were conducted. The primary objective of the study was to evaluate the effects of neflamapimod on cognition, and accordingly the primary endpoint was change in combined z-score of the six tests in the NTB, analyzed by Linear Mixed Effects (LME) model for repeated measures.||0.345|0.001|0.049
71828806|NCT04001517|143161877|SUPERIORITY|Comparison of combined neflamapimod groups vs. placebo.|||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
71887136|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.1|||||TWO_SIDED|90.0|42.74|177.5||||||Norbuprenorphine||177.50|42.74|
71887137|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|182.98|||||TWO_SIDED|90.0|89.79|372.89||||||Norbuprenorphine||372.89|89.79|
71716814|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716815|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71767991|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.656|TWO_SIDED|95.0|-0.305|0.192||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.192|-0.305|0.656
71767992|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71767993|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.124||0.777|TWO_SIDED|95.0|-0.279|0.209||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.209|-0.279|0.777
71767994|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828807|NCT04001517|143161878|SUPERIORITY|Comparison of combined neflamapimod 40mg TID vs. placebo. The p-value is not adjusted for multiple comparisons.|Mean Difference (Net)|-0.56||||0.007|TWO_SIDED|95.0|-0.96|-0.16||Comparison of combined neflamapimod dose groups vs. placebo utilizing mixed model for repeated measures with baseline as a covariate. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||The comparison is of neflamapimod 40mg TID to placebo. A negative value indicates improvement compared to placebo.|||-0.16|-0.96|0.007
71828808|NCT04001517|143161878|SUPERIORITY||Mean Difference (Net)|-0.45||||0.023|TWO_SIDED|95.0|-0.83|-0.06||Mixed model for repeated measures with baseline as a covariate. The p-value was not adjusted for multiple comparisons|Mixed Models Analysis||Comparison of combined neflamapimod dose groups vs. placebo. Negative values represents a better outcome with neflamapimod relative to placebo.|A secondary analysis was conducted comparing the combined neflamapimod dose groups vs. placebo.||-0.06|-0.83|0.023
71828809|NCT04001517|143161879|SUPERIORITY||||||>|0.2|||||||Mixed Models Analysis|||||||>0.2
71828810|NCT04001517|143161880|OTHER||Mean Difference (Net)|-1.53||||0.15|TWO_SIDED|95.0|-3.61|0.55|||Mixed Models Analysis|||||.55|-3.61|0.15
71828811|NCT04001517|143161880|SUPERIORITY||Mean Difference (Net)|-1.31||||0.077|TWO_SIDED|95.0|-5.03|2.34|||Mixed Models Analysis|||Comparison of combined neflamapimod groups (i.e., all neflamapimod) vs. placebo||2.34|-5.03|0.077
71828812|NCT04001517|143161881|SUPERIORITY||Mean Difference (Net)|0.32|||>|0.2|TWO_SIDED|95.0|-1.27|1.91|||Mixed Models Analysis||Comparison of change from baseline over course of study for NFMD 40mg TID vs. placebo.|||1.91|-1.27|>0.2
71767995|NCT02880956|143037269|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.128||0.256|TWO_SIDED|95.0|-0.106|0.397||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.397|-0.106|0.256
71828813|NCT04001517|143161882|OTHER||Mean Difference (Net)|-1.4||||0.024|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis||Mean difference for the comparison of 40 mg TID vs. placebo is reported.|||-0.2|-2.6|0.024
71828814|NCT04001517|143161882|SUPERIORITY|Comparison of combined neflamapimod dose groups vs. placebo.|Mean Difference (Net)|-1.36||||0.044|TWO_SIDED|95.0|-2.69|-0.04|||Mixed Models Analysis|||||-0.04|-2.69|0.044
71828815|NCT03399370|143161924|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-57.64|||<|0.0001|TWO_SIDED|95.0|-60.86|-54.43||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-54.43|-60.86|<.0001
71767996|NCT02880956|143037269|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|0.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71716816|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71767997|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.479|TWO_SIDED|95.0|-0.269|0.126||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.126|-0.269|0.479
71767998|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71767999|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.295|TWO_SIDED|95.0|-0.299|0.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.091|-0.299|0.295
71828816|NCT03399370|143161925|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-53.78|||<|0.0001|TWO_SIDED|95.0|-56.23|-51.33||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-51.33|-56.23|<0.0001
71887138|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|122.77|||||TWO_SIDED|90.0|60.24|250.19||||||Norbuprenorphine||250.19|60.24|
71716817|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716818|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716819|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716820|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 15). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716821|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 16). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716822|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 17). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716823|NCT00755807|142948086|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for test of mean change from extension phase baseline to endpoint (Week 18). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline\* Week, where participant was treated as a random effect.||||||<0.001
71716824|NCT00755807|142948087|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|1-sample t-test of mean change from extension phase baseline to endpoint on BDI-II Question #9 score for all participants who entered extension phase.||||||0.706
71716825|NCT00755807|142948091|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on monocytes.||||||0.035
71828817|NCT03399370|143161926|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-54.12|||<|0.0001|TWO_SIDED|95.0|-57.37|-50.88||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.88|-57.37|<0.0001
71716826|NCT00755807|142948092|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on sodium.||||||0.042
71716827|NCT00755807|142948093|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on total protein.||||||0.036
71716828|NCT00755807|142948094|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on diastolic blood pressure.||||||0.320
71716829|NCT00755807|142948094|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on systolic blood pressure.||||||0.182
71716830|NCT00755807|142948095|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on pulse rate.||||||0.032
71716831|NCT00755807|142948096|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on weight.||||||0.151
71716832|NCT03531814|142948100|OTHER|||||||0.006||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 1-4.|ANOVA|||||||0.006
71716833|NCT03531814|142948100|OTHER|||||||0.021||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 5-8.|ANOVA|||||||0.021
71716834|NCT03531814|142948100|OTHER|||||||0.034||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 9-12.|ANOVA|||||||.034
71716835|NCT03531814|142948100|OTHER|||||||0.04||||||The Greenhouse-Geisser correction was used because Mauchly's test of sphericity was significant. The reported p-value represents the probability of the differences in the averages of adherence assessment methods for cycles 13-18.|ANOVA|||||||.040
71716836|NCT03531814|142948101|OTHER||Spearman's correlation|-0.21||||0.536|TWO_SIDED|95.0|-0.729|0.463||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.463|-0.729|0.536
71887139|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|69.12|||||TWO_SIDED|90.0|33.45|142.82||||||Naloxone||142.82|33.45|
71656879|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.6|||||TWO_SIDED|95.0|-5.2|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||8.55|-5.20|
71656880|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.8|||||TWO_SIDED|95.0|-11.79|2.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||2.16|-11.79|
71656881|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.5|||||TWO_SIDED|95.0|-13.51|0.54|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3||0.54|-13.51|
71656882|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|3.1|||||TWO_SIDED|95.0|-0.84|7.13|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||7.13|-0.84|
71656883|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||TWO_SIDED|95.0|-3.14|4.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||4.11|-3.14|
71656884|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||TWO_SIDED|95.0|-6.72|1.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5||1.40|-6.72|
71656885|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||TWO_SIDED|95.0|-0.87|3.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||3.02|-0.87|
71656886|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||TWO_SIDED|95.0|-1.62|1.71|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||1.71|-1.62|
71656887|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||TWO_SIDED|95.0|-3.0|0.92|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A||0.92|-3.00|
71656888|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||TWO_SIDED|95.0|-0.62|4.67|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||4.67|-0.62|
71656889|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||TWO_SIDED|95.0|-2.67|1.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||1.55|-2.67|
71656890|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||TWO_SIDED|95.0|-5.11|-0.01|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F||-0.01|-5.11|
71656891|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||TWO_SIDED|95.0|-0.45|2.1|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||2.10|-0.45|
71656892|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||TWO_SIDED|95.0|-0.75|1.58|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.58|-0.75|
71656893|NCT00444457|142831453|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||TWO_SIDED|95.0|-1.86|1.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A||1.05|-1.86|
71656894|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||0.13|-0.10|
71656895|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.29|||||TWO_SIDED|95.0|-0.41|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.17|-0.41|
71656896|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.31|||||TWO_SIDED|95.0|-0.43|-0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4||-0.19|-0.43|
71656897|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.30|0.06|
71656898|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.12|||||TWO_SIDED|95.0|0.0|0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.23|-0.00|
71656899|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.18|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B||0.06|-0.18|
71768000|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.77|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768001|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.102||0.884|TWO_SIDED|95.0|-0.186|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.215|-0.186|0.884
71768002|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828818|NCT03399370|143161927|SUPERIORITY||Mean Difference (Final Values)|-53.28|||<|0.0001|TWO_SIDED|95.0|-55.75|-50.8||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-50.80|-55.75|<0.0001
71828819|NCT03399370|143161928|SUPERIORITY||Mean Difference (Final Values)|-83.8|||<|0.0001|TWO_SIDED|95.0|-89.25|-77.34||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-77.34|-89.25|<0.0001
71828820|NCT03399370|143161929|SUPERIORITY||Mean Difference (Final Values)|-33.13|||<|0.0001|TWO_SIDED|95.0|-35.3|-30.97||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-30.97|-35.30|<0.0001
71828821|NCT03399370|143161930|SUPERIORITY||Mean Difference (Final Values)|-43.09|||<|0.0001|TWO_SIDED|95.0|-45.5|-40.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.67|-45.50|<.0001
71656900|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
71768003|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.569|TWO_SIDED|95.0|-0.281|0.155||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.155|-0.281|0.569
71768004|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768005|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.702|TWO_SIDED|95.0|-0.254|0.171||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.171|-0.254|0.702
71768006|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828822|NCT03399370|143161931|SUPERIORITY||Mean Difference (Final Values)|-47.36|||<|0.0001|TWO_SIDED|95.0|-50.25|-44.47||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-44.47|-50.25|<0.0001
71828823|NCT00667745|143161986|SUPERIORITY||F value, main effect|0.94||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
71828824|NCT00667745|143161987|SUPERIORITY||Chi-squared|0.0||||0.967|TWO_SIDED||||||Chi-squared|||||||0.967
71828825|NCT00667745|143161988|SUPERIORITY||Mean Difference (Net)|0.45||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
71656901|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.15|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.07|-0.15|
71656902|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V||0.09|-0.13|
71656903|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.19|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.06|-0.19|
71656904|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.04|||||TWO_SIDED|95.0|-0.17|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.08|-0.17|
71656905|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.11|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14||0.15|-0.11|
71656906|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.00|-0.25|
71656907|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.24|||||TWO_SIDED|95.0|-0.37|-0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||-0.12|-0.37|
71656908|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.12|||||TWO_SIDED|95.0|-0.25|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C||0.01|-0.25|
71656909|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.18|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||0.11|-0.18|
71828826|NCT00667745|143161989|SUPERIORITY||Mean Difference (Net)|0.02||||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
71716837|NCT03531814|142948101|OTHER||Spearman's correlation|0.134||||0.713|TWO_SIDED|95.0|-0.557|0.715||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.715|-0.557|.713
71716838|NCT03531814|142948101|OTHER||Spearman's correlation|0.095||||0.823|TWO_SIDED|95.0|-0.668|0.761||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.761|-0.668|.823
71716839|NCT03531814|142948101|OTHER||Spearman's correlation|0.333||||0.42|TWO_SIDED|95.0|-0.505|0.848||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.848|-0.505|.420
71716840|NCT03531814|142948102|OTHER||Spearman's correlation|-0.333||||0.317|TWO_SIDED|95.0|-0.785|0.352||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.352|-0.785|0.317
71716841|NCT03531814|142948102|OTHER||Spearman's correlation|-0.309||||0.385|TWO_SIDED|95.0|-0.794|0.416||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.416|-0.794|.385
71828827|NCT00667745|143161990|SUPERIORITY||Mean Difference (Net)|0.92||||0.49|TWO_SIDED|||||Value shown above describes emergent suicidal ideation for participants with baseline MSSI = 0. P=.36 describes exacerbation of baseline suicidal ideation for those with baseline MSSI \> 0.|Mixed Models Analysis|||||||.49
71828828|NCT04493242|143161994|OTHER|log-rank test||||||0.1343|||||||Chi-squared|||||||0.1343
71828829|NCT01942707|143162000|SUPERIORITY||Mean Difference (Final Values)|179.0|STANDARD_DEVIATION|222.0||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
71828830|NCT01942707|143162001|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.9||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.012
71828831|NCT01942707|143162002|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_DEVIATION|40.7||0.809|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.809
71828832|NCT04541303|143162014|SUPERIORITY|||||||0.028|||||||None specified|||||||.028
71716842|NCT03531814|142948102|OTHER||Spearman's correlation|-0.259||||0.535|TWO_SIDED|95.0|-0.824|0.563||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.563|-0.824|.535
71716843|NCT03531814|142948102|OTHER||Spearman's correlation|-0.222||||0.597|TWO_SIDED|95.0|-0.811|0.589||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.589|-0.811|.597
71716844|NCT03531814|142948103|OTHER||Spearman's correlation|-0.215||||0.526|TWO_SIDED|95.0|-0.731|0.459||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.459|-0.731|0.526
71828833|NCT03538041|143162030|SUPERIORITY|||||||0.2815|||||||ANOVA|||Week 2||||0.2815
71828834|NCT03538041|143162031|SUPERIORITY|||||||0.2921|||||||Kruskal-Wallis|||Week 2||||0.2921
71828835|NCT03538041|143162032|SUPERIORITY|||||||0.1267|||||||ANOVA|||Week 2||||0.1267
71828836|NCT03538041|143162033|SUPERIORITY|||||||0.2676|||||||ANOVA|||Week 2||||0.2676
71716845|NCT03531814|142948103|OTHER||Spearman's correlation|0.049||||0.894|TWO_SIDED|95.0|-0.613|0.67||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.670|-0.613|.894
71716846|NCT03531814|142948103|OTHER||Spearman's correlation|-0.048||||0.911|TWO_SIDED|95.0|-0.74|0.694||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12|Spearman correlation (non-parametric)|||||0.694|-0.740|.911
71716847|NCT03531814|142948103|OTHER||Spearman's correlation|-0.167||||0.693|TWO_SIDED|95.0|-0.79|0.626||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18|Spearman correlation (non-parametric)|||||0.626|-0.790|.693
71716848|NCT03531814|142948104|OTHER||Spearman's correlation|-0.607||||0.048|TWO_SIDED|95.0|-0.889|0.009||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.009|-0.889|0.048
71716849|NCT03531814|142948104|OTHER||Spearman's correlation|-0.658||||0.038|TWO_SIDED|95.0|-0.914|-0.027||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||-0.027|-0.914|0.038
71716850|NCT03531814|142948104|OTHER||Spearman's correlation|-0.708||||0.5|TWO_SIDED|95.0|-0.945|0.02||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.020|-0.945|0.50
71716851|NCT03531814|142948104|OTHER||Spearman's correlation|-0.878||||0.004|TWO_SIDED|95.0|-0.979|-0.435||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.435|-0.979|0.004
71828837|NCT01324453|143162069|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||||||0.90
71828838|NCT01324453|143162070|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||0.81
71828839|NCT01324453|143162071|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
71828840|NCT01324453|143162072|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71828841|NCT01324453|143162073|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||||||0.86
71828842|NCT01324453|143162074|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.00
71828843|NCT01324453|143162075|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||0.58
71828844|NCT01324453|143162076|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
71828845|NCT00465816|143162126|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenA GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.22|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.22|0.8|
71828846|NCT00465816|143162126|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenC GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.21|0.68|
71716852|NCT03531814|142948105|OTHER||Spearman's correlation|0.293||||0.382|TWO_SIDED|95.0|-0.39|0.768||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.768|-0.390|0.382
71716853|NCT03531814|142948105|OTHER||Spearman's correlation|0.278||||0.436|TWO_SIDED|95.0|-0.444|0.781||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Spearman correlation (non-parametric)|||||0.781|-0.444|0.436
71716854|NCT03531814|142948105|OTHER||Spearman's correlation|0.229||||0.586|TWO_SIDED|95.0|-0.585|0.813||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 9-12.|Spearman correlation (non-parametric)|||||0.813|-0.585|0.586
71716855|NCT03531814|142948105|OTHER||Spearman's correlation|0.53||||0.177|TWO_SIDED|95.0|-0.302|0.904||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||0.904|-0.302|0.177
71716856|NCT03531814|142948107|OTHER||Spearman's correlation|-0.576||||0.063|TWO_SIDED|95.0|-0.879|0.056||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 1-4.|Spearman correlation (non-parametric)|||||0.056|-0.879|0.063
71716857|NCT03531814|142948107|OTHER||Spearman's correlation|-0.68||||0.031|TWO_SIDED|95.0|-0.92|-0.066||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 5-8.|Wilcoxon (Mann-Whitney)|||||-0.066|-0.920|0.031
71887140|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|282.17|||||TWO_SIDED|90.0|141.59|562.3||||||Naloxone||562.30|141.59|
71887141|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1497.7|||||TWO_SIDED|90.0|724.85|3094.59||||||Naloxone||3094.59|724.85|
71656910|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.37|||||TWO_SIDED|95.0|-0.51|-0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.22|-0.51|
71656911|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.33|||||TWO_SIDED|95.0|-0.47|-0.2|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F||-0.20|-0.47|
71656912|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.17|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.11|-0.17|
71656913|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.22|-0.07|
71656914|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F||0.25|-0.03|
71656915|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.2|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.06|-0.20|
71656916|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.09|||||TWO_SIDED|95.0|-0.21|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.03|-0.21|
71656917|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.15|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1||0.11|-0.15|
71656918|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.06|||||TWO_SIDED|95.0|-0.06|0.18|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.18|-0.06|
71656919|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.07|||||TWO_SIDED|95.0|-0.18|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||0.04|-0.18|
71656920|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.13|||||TWO_SIDED|95.0|-0.25|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3||-0.01|-0.25|
71656921|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.17|||||TWO_SIDED|95.0|0.05|0.28|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.28|0.05|
71656922|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|0.0|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.21|-0.00|
71656923|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.06|||||TWO_SIDED|95.0|-0.17|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5||0.05|-0.17|
71656924|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.19|-0.04|
71656925|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.1|||||TWO_SIDED|95.0|-0.02|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.21|-0.02|
71716858|NCT03531814|142948107|OTHER||Spearman's correlation|-0.835||||0.01|TWO_SIDED|95.0|-0.971|-0.292||The reported p-value represents the strength of the relationship between the variables at cycles 9-12.|Spearman correlation (non-parametric)|||||-0.292|-0.971|0.010
71716859|NCT03531814|142948107|OTHER||Spearman's correlation|-0.933|||<|0.001|TWO_SIDED|95.0|-0.989|-0.652||The reported p-value represents the probability that the strength of the relationship is due to chance at cycles 13-18.|Spearman correlation (non-parametric)|||||-0.652|-0.989|<0.001
71716860|NCT03531814|142948108|OTHER||Spearman's correlation|-0.035||||0.919|TWO_SIDED|95.0|-0.634|0.591||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||0.591|-0.634|0.919
71716861|NCT03531814|142948108|OTHER||Spearman's correlation|0.227||||0.528|TWO_SIDED|95.0|-0.487|0.759||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.759|-0.487|0.528
71716862|NCT03531814|142948108|OTHER||Spearman's correlation|0.179||||0.672|TWO_SIDED|95.0|-0.618|0.794||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.794|-0.618|0.672
71716863|NCT03531814|142948108|OTHER||Spearman's correlation|0.041||||0.923|TWO_SIDED|95.0|-0.697|0.737||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.737|-0.697|0.923
71716864|NCT03531814|142948109|OTHER||Spearman's correlation|-0.638||||0.035|TWO_SIDED|95.0|-0.899|-0.041||The reported p-value represents the strength of the relationship between the variables for cycles 1-4.|Spearman correlation|||||-0.041|-0.899|0.035
71716865|NCT03531814|142948109|OTHER||Spearman's correlation|-0.361||||0.306|TWO_SIDED|95.0|-0.815|0.367||The reported p-value represents the strength of the relationship between the variables for cycles 5-8.|Spearman correlation|||||0.367|-0.815|0.306
71716866|NCT03531814|142948109|OTHER||Spearman's correlation|-0.407||||0.317|TWO_SIDED|95.0|-0.87|0.438||The reported p-value represents the strength of the relationship between the variables for cycles 9-12.|Spearman correlation|||||0.438|-0.870|0.317
71768007|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.111||0.566|TWO_SIDED|95.0|-0.155|0.283||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.283|-0.155|0.566
71768008|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768009|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.141|TWO_SIDED|95.0|-0.458|0.065||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.065|-0.458|0.141
71887142|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|87.64|||||TWO_SIDED|90.0|40.3|190.59||||||Naloxone||190.59|40.30|
71716867|NCT03531814|142948109|OTHER||Spearman's correlation|-0.18||||0.67|TWO_SIDED|95.0|-0.795|0.0617||The reported p-value represents the strength of the relationship between the variables for cycles 13-18.|Spearman correlation|||||0.0617|-0.795|0.670
71716868|NCT00952705|142948145|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.|Ratio of geometric mean titers|0.95|||||TWO_SIDED|95.0|0.87|1.03|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.03|0.87|
71768010|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768011|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.131||0.834|TWO_SIDED|95.0|-0.285|0.23||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.230|-0.285|0.834
71768012|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768013|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.133||0.724|TWO_SIDED|95.0|-0.309|0.215||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.215|-0.309|0.724
71768014|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768015|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.166||0.163|TWO_SIDED|95.0|-0.559|0.095||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.095|-0.559|0.163
71887143|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|78.86|||||TWO_SIDED|90.0|34.34|181.12||||||Naloxone||181.12|34.34|
71887144|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|321.94|||||TWO_SIDED|90.0|144.65|716.52||||||Naloxone||716.52|144.65|
71887145|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|1708.83|||||TWO_SIDED|90.0|744.08|3924.47||||||Naloxone||3924.47|744.08|
71887146|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|84.2|||||TWO_SIDED|90.0|60.92|116.38||||||Naloxone-3-β-D-Glucuronide||116.38|60.92|
71887147|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|110.98|||||TWO_SIDED|90.0|82.02|150.17||||||Naloxone-3-β-D-Glucuronide||150.17|82.02|
71828847|NCT00465816|143162126|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenW-135 GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.02|||||TWO_SIDED|95.0|0.87|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.87|
71887148|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|81.97|||||TWO_SIDED|90.0|60.03|111.92||||||Naloxone-3-β-D-Glucuronide||111.92|60.03|
71887149|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|82.78|||||TWO_SIDED|90.0|59.89|114.42||||||Naloxone-3-β-D-Glucuronide||114.42|59.89|
71716869|NCT00952705|142948145|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.|Ratio of geometric mean titers|0.93|||||TWO_SIDED|95.0|0.85|1.0|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.00|0.85|
71716870|NCT00952705|142948145|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.|Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.79|1.02|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.02|0.79|
71716871|NCT00952705|142948145|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.|Ratio of geometric mean titers|0.97|||||TWO_SIDED|95.0|0.87|1.1|||Bootstrapping method|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog\^y (mean \[log\^y x\]) where x was the assay result and y was the natural logarithm.||1.10|0.87|
71716872|NCT05173974|142948192|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.037|TWO_SIDED|95.0|0.01|0.29||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|||0.29|0.01|0.037
71716873|NCT05173974|142948192|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.044|TWO_SIDED|95.0|0.0|0.28||P-value included Bonferroni adjustment.|ANCOVA||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participant included as a random effect.|||0.28|0.00|0.044
71716874|NCT05173974|142948192|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.005|TWO_SIDED|95.0|0.06|0.3||unadjusted P-value was presented.|ANCOVA||||ANCOVA with treatment and period as fixed effects; covariates for participant level baseline (natural logged) and period level baseline (natural logged) minus participant level baseline (natural logged). Participants included as a random effect.|0.30|0.06|0.005
71716875|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.218|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.17|-0.04|0.218
71828848|NCT00465816|143162126|NON_INFERIORITY|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenY GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.01|||||TWO_SIDED|95.0|0.85|1.19|||ANCOVA|||To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.||1.19|0.85|
71887150|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|101.71|||||TWO_SIDED|90.0|74.96|138.0||||||Naloxone-3-β-D-Glucuronide||138.00|74.96|
71716876|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.034|TWO_SIDED|95.0|0.01|0.21|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.21|0.01|0.034
71716877|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.004|TWO_SIDED|95.0|0.05|0.25|||ANCOVA||Statistical comparison for AOB 0-0.5|||0.25|0.05|0.004
71716878|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.058|TWO_SIDED|95.0|0.0|0.24|||ANCOVA||Statistical comparison for AOB 0-1|||0.24|-0.00|0.058
71716879|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.017|TWO_SIDED|95.0|0.03|0.27|||ANCOVA||Statistical comparison for AOB 0-1|||0.27|0.03|0.017
71716880|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.001|TWO_SIDED|95.0|0.09|0.33|||ANCOVA||Statistical comparison for AOB 0-1|||0.33|0.09|0.001
71887151|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|134.06|||||TWO_SIDED|90.0|101.07|177.82||||||Naloxone-3-β-D-Glucuronide||177.82|101.07|
71887152|NCT01846455|143294670|SUPERIORITY_OR_OTHER||ratio of parameter means, %|99.02|||||TWO_SIDED|90.0|73.93|132.61||||||Naloxone-3-β-D-Glucuronide||132.61|73.93|
71887153|NCT03222427|143294681|OTHER||Ratio of Geometric Least Squares Means|0.952|||||TWO_SIDED|90.0|0.769|1.18||||||||1.18|0.769|
71887154|NCT01970176|143294683|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71887155|NCT01970176|143294684|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71887156|NCT01970176|143294685|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71828849|NCT00465816|143162127|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-1.19|3.9||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.||3.9|-1.19|
71828850|NCT00465816|143162128|NON_INFERIORITY|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|-0.91|||||TWO_SIDED|95.0|-2.64|2.92||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.||2.92|-2.64|
71828851|NCT02477670|143162188|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.79||||0.073|TWO_SIDED|95.0|-3.75|0.17|||Mixed Models Analysis|||Sequential Parallel Comparison Design (SPCD) Weighted Ordinary Least Squares (OLS) z-statistic. Treatment differences in each stage were estimated by the Mixed Model Repeated Measures (MMRM).||0.17|-3.75|0.073
71828852|NCT02477670|143162189|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.25||||0.025|TWO_SIDED|95.0|-4.21|-0.29|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.29|-4.21|0.025
71828853|NCT02477670|143162190|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.2||||0.027|TWO_SIDED|95.0|-4.16|-0.24|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.24|-4.16|0.027
71828854|NCT02477670|143162191|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.26||||0.024|TWO_SIDED|95.0|-4.22|-0.3|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.3|-4.22|0.024
71828855|NCT02477670|143162192|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.6||||0.009|TWO_SIDED|95.0|-4.56|-0.64|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.64|-4.56|0.009
71828856|NCT02477670|143162193|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.39||||0.7|TWO_SIDED|95.0|-2.35|1.57|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.57|-2.35|0.700
71828857|NCT02477670|143162194|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.93||||0.054|TWO_SIDED|95.0|-3.89|0.03|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.03|-3.89|0.054
71887157|NCT03106779|143294686|SUPERIORITY||treatment difference in the MMR rate|12.2||||0.029|TWO_SIDED|95.0|2.19|22.3|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factor, i.e. cytogenetic response status (MCyR vs no MCyR) at screening||||22.30|2.19|0.029
71887158|NCT02288247|143294701|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.027|TWO_SIDED|95.0|0.53|0.96||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.96|0.53|0.027
71887159|NCT02288247|143294702|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.002|TWO_SIDED|95.0|0.41|0.82||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||0.82|0.41|0.002
71716881|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.004|TWO_SIDED|95.0|0.06|0.3|||ANCOVA||Statistical comparison for AOB 0-3|||0.30|0.06|0.004
71828858|NCT02477670|143162195|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.35||||0.723|TWO_SIDED|95.0|-2.31|1.61|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.61|-2.31|0.723
71716882|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.01|TWO_SIDED|95.0|0.04|0.27|||ANCOVA||Statistical comparison for AOB0-3|||0.27|0.04|0.010
71716883|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.31|||ANCOVA||Statistical comparison for AOB0-3|||0.31|0.07|0.002
71716884|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.022|TWO_SIDED|95.0|0.02|0.29|||ANCOVA||Statistical comparison for AOB 0-6|||0.29|0.02|0.022
71716885|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.011|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-6|||0.30|0.04|0.011
71716886|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.33|||ANCOVA||Statistical comparison for AOB 0-6|||0.33|0.06|0.005
71716887|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.037|TWO_SIDED|95.0|0.01|0.27|||ANCOVA||Statistical comparison for AOB 0-9|||0.27|0.01|0.037
71716888|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.013|TWO_SIDED|95.0|0.04|0.3|||ANCOVA||Statistical comparison for AOB 0-9|||0.30|0.04|0.013
71716889|NCT05173974|142948193|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.005|TWO_SIDED|95.0|0.06|0.32|||ANCOVA||Statistical comparison for AOB 0-9|||0.32|0.06|0.005
71828859|NCT02477670|143162196|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.85||||0.064|TWO_SIDED|95.0|-3.81|0.11|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.11|-3.81|0.064
71828860|NCT02477670|143162197|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.64||||0.1|TWO_SIDED|95.0|-3.6|0.32|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.32|-3.6|0.100
71828861|NCT02477670|143162198|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.86||||0.388|TWO_SIDED|95.0|-2.82|1.1|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.1|-2.82|0.388
71887160|NCT02288247|143294704|SUPERIORITY|||||||0.142||||||From the Cochran-Mantel-Haenszel test stratified by disease progression (radiographic, non-radiographic) in Period 1.|Cochran-Mantel-Haenszel|||||||0.142
71887161|NCT02288247|143294707|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.994|TWO_SIDED|95.0|0.47|2.13||From the Cox proportional hazards model with covariates for treatment and disease progression in Period 1 (radiographic, nonradiographic).|Cox proportional hazards model|||||2.13|0.47|0.994
71887162|NCT02918019|143294732|OTHER||Rate Ratio|0.57||||0.0049|TWO_SIDED|95.0|0.39|0.84|||Poisson regression|||||0.84|0.39|0.0049
71887163|NCT02918019|143294732|OTHER||Rate Ratio|0.78||||0.1838|TWO_SIDED|95.0|0.54|1.12|||Poisson regression|||||1.12|0.54|0.1838
71887164|NCT02918019|143294732|OTHER||Rate Ratio|0.63||||0.0144|TWO_SIDED|95.0|0.44|0.91|||Poisson regression|||||0.91|0.44|0.0144
71716890|NCT02098304|142948194|SUPERIORITY_OR_OTHER||Percentage agreement|72.3|||<|0.001|TWO_SIDED|95.0|59.8|82.7|||Exact binomial test|An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.||The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.||82.7|59.8|<0.001
71716891|NCT02098304|142948194|SUPERIORITY_OR_OTHER||Cohen's kappa|0.45||||0.001|TWO_SIDED|95.0|0.24|0.66|||Cohen's Kappa||Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.|The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen's kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.||0.66|0.24|0.001
71716892|NCT03257358|142948198|OTHER|Estimation|least squares mean|-413.4|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-422.7||||ANCOVA|||||-404.|-422.7|
71716893|NCT03257358|142948198|OTHER|Estimation|least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.9|3.6|||ANCOVA|||||3.6|-3.9|
71716894|NCT03257358|142948199|OTHER|Estimation|least squares mean|-368.7|STANDARD_ERROR_OF_MEAN|7.08|||TWO_SIDED|95.0|-382.8|354.7|||ANCOVA|||||354.7|-382.8|
71716895|NCT03257358|142948199|OTHER|Estimation|least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-7.1|6.9|||ANCOVA|||||6.9|-7.1|
71716896|NCT03257358|142948200|OTHER|Estimation|least squares mean|-52.1|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-57.2|-46.9|||ANCOVA|||||-46.9|-57.2|
71716897|NCT03257358|142948200|OTHER|Estimation|least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-7.6|1.4|||ANCOVA|||||1.4|-7.6|
71716898|NCT03257358|142948201|OTHER|Estimation|least squares mean|-43.6|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-46.9|-40.3|||ANCOVA|||||-40.3|-46.9|
71828862|NCT02477670|143162199|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.9||||0.367|TWO_SIDED|95.0|-2.86|1.06|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.06|-2.86|0.367
71828863|NCT02477670|143162200|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.76||||0.447|TWO_SIDED|95.0|-2.72|1.2|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.2|-2.72|0.447
71716899|NCT03257358|142948201|OTHER|Estimation|least squares mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-3.0|1.7|||ANCOVA|||||1.7|-3.0|
71828864|NCT02477670|143162201|SUPERIORITY||SPCD Weighted OLS z-statistic|-2.23||||0.026|TWO_SIDED|95.0|-4.19|-0.27|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||-0.27|-4.19|0.026
71716900|NCT03257358|142948202|OTHER|Estimation|least squares mean|-36.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-37.2|-35.3|||ANCOVA|||||-35.3|-37.2|
71716901|NCT03257358|142948202|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||||1.2|-0.4|
71716902|NCT03257358|142948203|OTHER|Estimation|least squares mean|-53.2|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-55.1|-51.3|||ANCOVA|||||-51.3|-55.1|
71716903|NCT03257358|142948203|OTHER|Estimation|least squares mean|0.4|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||||1.4|-0.7|
71716904|NCT03257358|142948204|OTHER|Estimation|least squares mean|-140.4|STANDARD_ERROR_OF_MEAN|2.71|||TWO_SIDED|95.0|-145.8|-135.0|||ANCOVA|||||-135.0|-145.8|
71716905|NCT03257358|142948204|OTHER|Estimation|least squares mean|0.7|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-1.9|3.3|||ANCOVA|||||3.3|-1.9|
71716906|NCT03257358|142948205|OTHER|Estimation|least squares mean|-85.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-89.0|-81.4|||ANCOVA|||||-81.4|-89.0|
71716907|NCT03257358|142948205|OTHER|Estimation|least squares mean|0.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.3|1.9|||ANCOVA|||||1.9|-2.3|
71716908|NCT03257358|142948206|OTHER|Estimation|least squares mean|-27.9|STANDARD_ERROR_OF_MEAN|11.65|||TWO_SIDED|95.0|-51.1|-4.8|||ANCOVA|||||-4.8|-51.1|
71716909|NCT03257358|142948206|OTHER|Estimation|least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|3.47|||TWO_SIDED|95.0|-16.3|-2.6|||ANCOVA|||||-2.6|-16.3|
71716910|NCT03257358|142948207|OTHER|Estimation|least squares mean|-181.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-183.3|-179.0|||ANCOVA|||||-179.0|-183.3|
71716911|NCT03257358|142948207|OTHER|Estimation|least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-4.1|2.5|||ANCOVA|||||2.5|-4.1|
71716912|NCT03257358|142948208|OTHER|Estimation|least squares mean|-55.2|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-56.5|-53.9|||ANCOVA|||||-53.9|-56.5|
71716913|NCT03257358|142948208|OTHER|Estimation|least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||||1.1|-0.5|
71716914|NCT03257358|142948209|OTHER|Estimation|least squares mean|-7.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-8.0|-6.4|||ANCOVA|||||-6.4|-8.0|
71716915|NCT03257358|142948209|OTHER|Estimation|least squares mean|1.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|0.3|2.0|||ANCOVA|||||2.0|0.3|
71716916|NCT03257358|142948210|OTHER|Estimation|least squares mean|69.4|STANDARD_ERROR_OF_MEAN|13.78|||TWO_SIDED|95.0|42.1|96.7|||ANCOVA|||||96.7|42.1|
71716917|NCT03257358|142948210|OTHER|Estimation|least squares mean|117.0|STANDARD_ERROR_OF_MEAN|10.07|||TWO_SIDED|95.0|97.1|136.9|||ANCOVA|||||136.9|97.1|
71716918|NCT03257358|142948211|OTHER|Estimation|least squares mean|-782.6|STANDARD_ERROR_OF_MEAN|138.9|||TWO_SIDED|95.0|-1058.2|-507.1|||ANCOVA|||||-507.1|-1058.2|
71716919|NCT03257358|142948211|OTHER|Estimation|least squares mean|-485.9|STANDARD_ERROR_OF_MEAN|91.88|||TWO_SIDED|95.0|-667.3|-304.4|||ANCOVA|||||-304.4|-667.3|
71716920|NCT03257358|142948212|OTHER|Estimation|least squares mean|-33.3|STANDARD_ERROR_OF_MEAN|7.47|||TWO_SIDED|95.0|-48.2|-18.5|||ANCOVA|||||-18.5|-48.2|
71716921|NCT03257358|142948212|OTHER|Estimation|least squares mean|-25.8|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-36.7|-14.9|||ANCOVA|||||-14.9|-36.7|
71716922|NCT03257358|142948213|OTHER|Estimation|least squares mean|-888.7|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|95.0|-914.6|-862.7|||ANCOVA|||||-862.7|-914.6|
71716923|NCT03257358|142948213|OTHER|Estimation|least squares mean|-3.3|STANDARD_ERROR_OF_MEAN|7.24|||TWO_SIDED|95.0|-17.6|11.0|||ANCOVA|||||11.0|-17.6|
71716924|NCT03257358|142948214|OTHER|Estimation|least squares mean|-39.5|STANDARD_ERROR_OF_MEAN|1.053|||TWO_SIDED|95.0|-41.59|-37.42|||ANCOVA|||||-37.42|-41.59|
71828865|NCT02477670|143162202|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.62||||0.106|TWO_SIDED|95.0|-3.58|0.34|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||0.34|-3.58|0.106
71716925|NCT03257358|142948214|OTHER|Estimation|least squares mean|0.14|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.87|1.14|||ANCOVA|||||1.14|-0.87|
71716926|NCT03257358|142948215|OTHER|Estimation|least squares mean|-248.9|STANDARD_ERROR_OF_MEAN|15.0|||TWO_SIDED|95.0|-278.7|-219.2|||ANCOVA|||||-219.2|-278.7|
71716927|NCT03257358|142948215|OTHER|Estimation|least squares mean|-9.9|STANDARD_ERROR_OF_MEAN|7.71|||TWO_SIDED|95.0|-25.1|5.4|||ANCOVA|||||5.4|-25.1|
71716928|NCT03257358|142948216|OTHER|Estimation|least squares mean|5.6|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|3.13|8.08|||ANCOVA|||||8.08|3.13|
71716929|NCT03257358|142948216|OTHER|Estimation|least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.364|||TWO_SIDED|95.0|-0.68|0.76|||ANCOVA|||||0.76|-0.68|
71716930|NCT03257358|142948217|OTHER|Estimation|least squares mean|-231.0|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|-234.5|-227.6|||ANCOVA|||||-227.6|-234.5|
71716931|NCT03257358|142948217|OTHER|Estimation|least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-5.2|4.5|||ANCOVA|||||4.5|-5.2|
71716932|NCT03257358|142948218|OTHER|Estimation|least squares mean|-8.3|STANDARD_ERROR_OF_MEAN|0.455|||TWO_SIDED|95.0|-9.21|-7.4|||ANCOVA|||||-7.40|-9.21|
71887165|NCT00094757|143294747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.82|-0.39||Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|ANCOVA|||||-0.39|-0.82|<0.001
71887166|NCT00094757|143294747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|0.9|<|0.001|TWO_SIDED|95.0|-0.7|-0.26|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)||||-0.26|-0.70|<0.001
71716933|NCT03257358|142948218|OTHER|Estimation|least squares mean|0.32|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|-0.17|0.82|||ANCOVA|||||0.82|-0.17|
71716934|NCT03289143|142948246|SUPERIORITY|||||||0.6147||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6147
71716935|NCT03289143|142948246|SUPERIORITY|||||||0.5778||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5778
71716936|NCT03289143|142948246|SUPERIORITY|||||||0.5136||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5136
71716937|NCT03289143|142948248|SUPERIORITY|||||||0.8198||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.8198
71716938|NCT03289143|142948248|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
71716939|NCT03289143|142948248|SUPERIORITY|||||||0.6043||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6043
71716940|NCT03289143|142948249|SUPERIORITY|||||||0.0783||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.0783
71716941|NCT03289143|142948249|SUPERIORITY|||||||0.601||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.6010
71716942|NCT03289143|142948249|SUPERIORITY|||||||0.3961||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.3961
71716943|NCT03289143|142948250|SUPERIORITY|||||||0.9749||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.9749
71716944|NCT03289143|142948250|SUPERIORITY|||||||0.7718||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7718
71716945|NCT03289143|142948250|SUPERIORITY|||||||0.5789||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5789
71716946|NCT03289143|142948251|SUPERIORITY|||||||0.5235||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5235
71716947|NCT03289143|142948251|SUPERIORITY|||||||0.5612||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.5612
71716948|NCT03289143|142948251|SUPERIORITY|||||||0.713||||||Unadjusted|Mixed-effect Model Repeated Measures|||||||0.7130
71716949|NCT00730756|142948256|SUPERIORITY_OR_OTHER|||||||0.845||95.0|||||ANCOVA|Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.||||||0.845
71716950|NCT01126190|142948268|NON_INFERIORITY|Non-inferiority was demonstrated if the upper endpoint of the CI for the difference in mean DSN was less than or equal to 0.62 days|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.13|0.37||||||For the primary non-inferiority endpoint of cycle 1 DSN, the 95% confidence interval (CI) for difference in DSN was calculated by stratified bootstrap resampling.||0.37|-0.13|
71828866|NCT02477670|143162203|SUPERIORITY||SPCD Weighted OLS z-statistic|1.78||||0.074|TWO_SIDED|95.0|-0.18|3.74|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||3.74|-0.18|0.074
71828867|NCT02477670|143162204|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.79||||0.427|TWO_SIDED|95.0|-2.75|1.17|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||1.17|-2.75|0.427
71828868|NCT02477670|143162205|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.91||||0.0566|TWO_SIDED|95.0|-3.87|0.05|||McNemar|||Treatment differences in each stage were estimated by the MMRM.||0.05|-3.87|0.0566
71828869|NCT02477670|143162206|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.37||||0.17|TWO_SIDED|95.0|-3.33|0.59|||ANCOVA|||||0.59|-3.33|0.1700
71828870|NCT02477670|143162207|SUPERIORITY||SPCD Weighted OLS z-statistic|0.53||||0.595|TWO_SIDED|95.0|-1.43|2.49|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.49|-1.43|0.595
71828871|NCT02477670|143162208|SUPERIORITY||SPCD Weighted OLS z-statistic|2.284||||0.022|TWO_SIDED|95.0|0.324|4.244|||ANCOVA|||||4.244|0.324|0.022
71828872|NCT02477670|143162209|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.17||||0.862|TWO_SIDED|95.0|-2.13|1.79|||ANCOVA|||||1.79|-2.13|0.862
71828873|NCT02477670|143162210|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.149||||0.251|TWO_SIDED|95.0|-3.109|0.811|||ANCOVA|||||0.811|-3.109|0.251
71828874|NCT02477670|143162211|SUPERIORITY||SPCD Weighted OLS z-statistic|-1.159||||0.246|TWO_SIDED|95.0|-3.119|0.801|||ANCOVA|||||0.801|-3.119|0.246
71828875|NCT02477670|143162212|SUPERIORITY||SPCD Weighted OLS z-statistic|0.231||||0.818|TWO_SIDED|95.0|-1.729|2.191|||ANCOVA|||||2.191|-1.729|0.818
71828876|NCT02477670|143162213|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.04||||0.968|TWO_SIDED|95.0|-2.0|1.92|||ANCOVA|||||1.92|-2.00|0.968
71828877|NCT02477670|143162214|SUPERIORITY||SPCD Weighted OLS z-statistic|-0.306||||0.76|TWO_SIDED|95.0|-2.266|1.654|||ANCOVA|||||1.654|-2.266|0.760
71828878|NCT02477670|143162215|SUPERIORITY||SPCD Weighted OLS z-statistic|1.243||||0.214|TWO_SIDED|95.0|-0.717|3.203|||ANCOVA|||||3.203|-0.717|0.214
71828879|NCT02477670|143162216|SUPERIORITY|||||||0.071|||||||SPCD 1 degree of freedom score test|||||||0.071
71828880|NCT02477670|143162217|SUPERIORITY||SPCD Weighted OLS z-statistic|0.951||||-0.06|TWO_SIDED|95.0|-1.009|2.911|||Mixed Models Analysis|||Treatment differences in each stage were estimated by the MMRM.||2.911|-1.009|-0.06
71828881|NCT00854906|143162248|NON_INFERIORITY_OR_EQUIVALENCE|This was a pilot study. Therefore, no formal power analyses were performed.|Mean Difference (Final Values)|0.666|STANDARD_DEVIATION|3.6||0.074|TWO_SIDED|95.0|-0.069|1.401|||t-test, 2 sided|||The paired T-test was used to compare mean KTBUT and mean FTBUT.||1.401|-0.069|0.074
71716951|NCT01152307|142948272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|STANDARD_DEVIATION|1.6||0.01|TWO_SIDED|95.0|0.76|6.09|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||6.09|0.76|0.01
71716952|NCT00524121|142948277|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon signed rank test|||||||0.011
71716953|NCT00524121|142948278|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Log Rank|||||||0.115
71716954|NCT00524121|142948279|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71716955|NCT00524121|142948280|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71716956|NCT00524121|142948281|SUPERIORITY_OR_OTHER|||||||0.5467|||||||Fisher Exact|||||||0.5467
71716957|NCT01114737|142948282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.3||0.085|TWO_SIDED|95.0|-8.9|0.6|||ANCOVA|Adjusted for baseline ADHD-RS/ASRS total score, age group, and ADHD medication.||||0.6|-8.9|0.085
71716958|NCT01114737|142948283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.669|TWO_SIDED|95.0|-1.5|2.3|||ANCOVA|Adjusted for baseline HAMA Anxiety Scale Total Score, age group, ADHD symptom, and ADHD medication.||||2.3|-1.5|0.669
71716959|NCT01114737|142948284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.588|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|Adjusted for Baseline HAM-D Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.9|-1.1|0.588
71716960|NCT01114737|142948285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.531|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|Adjusted for baseline CGI-Severity Response, age group, ADHD symptom, and ADHD medication.||||0.2|-0.4|0.531
71716961|NCT01114737|142948286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.2||0.661|TWO_SIDED|95.0|-5.5|3.6|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||3.6|-5.5|0.661
71716962|NCT01114737|142948287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.9||0.034|TWO_SIDED|95.0|-7.9|-0.3|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||-0.3|-7.9|0.034
71828882|NCT00854906|143162249|NON_INFERIORITY_OR_EQUIVALENCE|The analysis will evaluate the association between OSDI with KTBUT.|Pearson's Correlation, r|-0.34||||0.093|ONE_SIDED||||||Pearson's correlation|||A correlation was performed between ODSI questionnaire results and each participant's KTBUT.||||0.093
71887167|NCT00094757|143294748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.7|STANDARD_DEVIATION|45.9|<|0.001|TWO_SIDED|95.0|-30.5|-8.9|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-8.9|-30.5|<0.001
71716963|NCT01114737|142948288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.6||0.312|TWO_SIDED|95.0|-2.6|7.8|||ANCOVA|Adjusted for Week 13 ADHD RS/ASRS Total Score, age group, and ADHD medication.||||7.8|-2.6|0.312
71716964|NCT01114737|142948289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.0||0.59|TWO_SIDED|95.0|-2.4|1.4|||ANCOVA|Adjusted for Week 13 HAMA Anxiety Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.||||1.4|-2.4|0.590
71716965|NCT01114737|142948290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.636|TWO_SIDED|95.0|-1.2|1.9|||ANCOVA|Adjusted for Week 13 HAMD Rating Scale Total Score, age group, ADHD symptom, and ADHD||||1.9|-1.2|0.636
71716966|NCT01114737|142948291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|Adjusted for Week 13 Global Impression-Severity Score, ADHD symptom, and ADHD medication.||||0.5|-0.2|0.510
71716967|NCT01114737|142948292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.8||0.395|TWO_SIDED|95.0|-2.1|5.2|||ANCOVA|Adjusted for Week 13 BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.2|-2.1|0.395
71716968|NCT01114737|142948293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.443|TWO_SIDED|95.0|-2.1|4.7|||ANCOVA|Adjusted for Week 13 BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||4.7|-2.1|0.443
71716969|NCT01114737|142948294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.8||0.953|TWO_SIDED|95.0|-5.5|5.8|||ANCOVA|Adjusted for Baseline ADHD-RS/ASRS Total Score, ADHD symptom, and ADHD medication.||||5.8|-5.5|0.953
71716970|NCT01114737|142948295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.733|TWO_SIDED|95.0|-2.4|1.7|||ANCOVA|Adjusted for Baseline Hamilton Anxiety Rating Scale (HAM-A) Score, ADHD symptom, and ADHD medication.||||1.7|-2.4|0.733
71828883|NCT00854906|143162249|SUPERIORITY_OR_OTHER||Pearson's Correlation, r|-0.26||||0.216|||||||Pearson's Correlation|||A correlation was performed between ODSI questionnaire results and each participant's FTBUT.||||0.216
71716971|NCT01114737|142948296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.522|TWO_SIDED|95.0|-1.1|2.2|||ANCOVA|Adjusted for Baseline Hamilton Rating Scale For Depression (HAM-D) Score, ADHD symptom, and ADHD medication.||||2.2|-1.1|0.522
71716972|NCT01114737|142948297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.564|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|Adjusted for Baseline Clinical Global Impression-Severity (CGI-S), ADHD symptom, and ADHD medication.||||0.4|-0.2|0.564
71716973|NCT01114737|142948298|SUPERIORITY_OR_OTHER||Relative Risk|0.87||||0.67|TWO_SIDED|95.0|0.46|1.64|||Cochran-Mantel-Haenszel|Adjusted for age group, ADHD symptom, and ADHD medication||||1.64|0.46|0.67
71716974|NCT01114737|142948299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.8||0.833|TWO_SIDED|95.0|-6.2|5.0|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.||||5.0|-6.2|0.833
71887168|NCT00094757|143294748|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.9|STANDARD_DEVIATION|45.9|<|0.002|TWO_SIDED|95.0|-27.6|-6.1|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status||||-6.1|-27.6|<0.002
71716975|NCT01114737|142948300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.279|TWO_SIDED|95.0|-6.3|1.8|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.||||1.8|-6.3|0.279
71716976|NCT00457392|142948308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.1933|TWO_SIDED|95.0|0.822|1.079||p-value was not adjusted for multiple comparisons.|Log Rank|||Differences in OS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and epidermal growth factor receptor (EGFR) status (positive, versus negative, versus unknown).||1.079|0.822|0.1933
71716977|NCT00457392|142948309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.807||||0.0023|TWO_SIDED|95.0|0.695|0.937||No p-value is adjusted for multiple comparisons for PFS.|Log Rank|One-sided log-rank test with alpha=0.025 was used.||Differences in PFS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown).||0.937|0.695|0.0023
71716978|NCT00457392|142948310|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.514||||0.0471|TWO_SIDED|95.0|1.002|2.289|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown) was used to compare ORR between the 2 treatment arms. The relative risk ratio estimator was used to contrast the treatment effects on response rates. A point estimate of relative risk ratio and 2-sided 95% CI was calculated.||2.289|1.002|0.0471
71716979|NCT01977898|142948320|SUPERIORITY|||||||0.877|||||||Fisher Exact|||A sample size of 65 patients in each group would be required to achieve 80% power to detect this difference between intrathecal morphine and saline administration . Sample size of 64 per group achieve 80% power to detect a difference between the group proportions of 0.25. The proportion in the treatment group is assumed to be 0.5 under the null hypothesis and 0.25 under the alternative hypothesis. The proportion in the control group is .05.The significance level of the test was targeted at .05.||||.877
71716980|NCT01977898|142948321|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
71716981|NCT01977898|142948322|SUPERIORITY|||||||0.463|||||||Chi-squared|||||||.463
71716982|NCT01977898|142948323|SUPERIORITY|||||||0.0463|||||||Chi-squared|||||||.0463
71716983|NCT01977898|142948324|SUPERIORITY|||||||0.525|||||||Chi-squared|||||||.525
71716984|NCT01977898|142948325|SUPERIORITY|||||||0.691|||||||Wilcoxon (Mann-Whitney)|||||||0.691
71716985|NCT01977898|142948326|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.610
71716986|NCT01977898|142948327|SUPERIORITY|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||.499
71716987|NCT01977898|142948328|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71716988|NCT01977898|142948329|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||.31
71716989|NCT02727322|142948335|SUPERIORITY||Risk Ratio (RR)|1.1||||0.97|TWO_SIDED|95.0|0.5|2.04|||Chi-squared|||||2.04|0.50|0.97
71716990|NCT02727322|142948336|SUPERIORITY||Risk Ratio (RR)|1.12||||0.665|TWO_SIDED|95.0|0.885|1.43|||Chi-squared|||||1.43|0.885|0.665
71716991|NCT02727322|142948337|SUPERIORITY||Risk Ratio (RR)|1.32||||1|TWO_SIDED|95.0|0.31|5.68|||Fisher Exact|||||5.68|0.31|1.0
71716992|NCT01049373|142948353|SUPERIORITY_OR_OTHER|||||||0.0426|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0426
71716993|NCT01049373|142948354|SUPERIORITY_OR_OTHER|||||||0.0757|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0757
71716994|NCT01049373|142948355|SUPERIORITY_OR_OTHER|||||||0.0465|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0465
71716995|NCT01049373|142948356|SUPERIORITY_OR_OTHER|||||||0.04443|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04443
71716996|NCT00339040|142948369|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
71716997|NCT00988156|142948376|SUPERIORITY_OR_OTHER|||||||0.249|||||||ANCOVA|||||||0.2490
71716998|NCT00988156|142948377|SUPERIORITY_OR_OTHER|||||||0.9017|||||||Cochran-Mantel-Haenszel|||||||0.9017
71716999|NCT01815424|142948387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.52|||<|0.0001|TWO_SIDED|95.0|6.03|32.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||32.77|6.03|<0.0001
71717000|NCT01815424|142948387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.27|||<|0.0001|TWO_SIDED|95.0|2.46|11.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||11.86|2.46|<0.0001
71717001|NCT01815424|142948388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|41.71|||<|0.0001|TWO_SIDED|95.0|14.84|151.11||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||151.11|14.84|<0.0001
71768016|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|0.24|STANDARD_DEVIATION|0.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71887169|NCT00756938|143294751|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.22||||0.753|TWO_SIDED|95.0|-6.45|8.9|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||8.90|-6.45|0.753
71717002|NCT01815424|142948388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.97|||<|0.0001|TWO_SIDED|95.0|4.06|25.17||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||25.17|4.06|<0.0001
71717003|NCT01815424|142948389|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-71.54|STANDARD_ERROR_OF_MEAN|8.461|<|0.0001|TWO_SIDED|95.0|-88.2|-54.87||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-54.87|-88.20|<0.0001
71887170|NCT00756938|143294752|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.81||||0.643|TWO_SIDED|95.0|-5.9|9.51|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage||||9.51|-5.90|0.643
71768017|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.163||0.497|TWO_SIDED|95.0|-0.432|0.21||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.210|-0.432|0.497
71768018|NCT02880956|143037270|SUPERIORITY||effect size|0.1|STANDARD_DEVIATION|1.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768019|NCT02880956|143037270|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.919|TWO_SIDED|95.0|-0.314|0.349||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.349|-0.314|0.919
71768020|NCT02880956|143037270|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828884|NCT01786564|143162260|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.075||||0.13|TWO_SIDED|95.0|-0.173|0.023||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|||The cross-sectional association between habitual sleep duration and oral disposition index was analyzed.||.023|-.173|.13
71828885|NCT01786564|143162260|OTHER|This is cross-sectional analysis|Regression Coefficient|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted.||The cross-sectional association between habitual sleep quality (sleep percentage) and oral disposition index was analyzed.||1.19|-0.95|.83
71768021|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.352||0.423|TWO_SIDED|95.0|-0.974|0.409||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.409|-0.974|0.423
71768022|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768023|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.346||0.036|TWO_SIDED|95.0|-1.408|-0.047||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.047|-1.408|0.036
71768024|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|2.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768025|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.355||0.121|TWO_SIDED|95.0|-1.25|0.147||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.147|-1.250|0.121
71828886|NCT01786564|143162260|OTHER|This is cross-sectional analysis in a single group.|Regression Coefficient|-0.05||||0.39|TWO_SIDED|95.0|-0.166|0.66||Unadjusted association. A priori p value of .05 was selected for statistical significance.|Regression, Linear|Unadjusted||The cross-sectional association between amount of Stage 3 sleep and oral disposition index was analyzed.||0.66|-.166|.39
71828887|NCT01786564|143162260|OTHER|Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression Coefficient|-0.058||||0.11|TWO_SIDED|95.0|-0.129|0.014||Unadjusted association. P value of .05 was selected a priori as statistical significance|Regression, Linear|Unadjusted association.||The cross-sectional association between amount of REM sleep and oral disposition index was analyzed.||.014|-.129|.11
71828888|NCT01924767|143162281|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|43.661|||||TWO_SIDED|95.0|27.52|69.269|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.||69.269|27.520|
71828889|NCT01924767|143162281|SUPERIORITY_OR_OTHER||Geometric Mean of ratio|31.234|||||TWO_SIDED|95.0|12.193|80.011|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.||80.011|12.193|
71717004|NCT01815424|142948389|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-52.12|STANDARD_ERROR_OF_MEAN|8.416|<|0.0001|TWO_SIDED|95.0|-68.7|-35.55||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-35.55|-68.70|<0.0001
71768026|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828890|NCT01924767|143162282|SUPERIORITY_OR_OTHER||Geometric mean of ratio|49.707|||||TWO_SIDED|95.0|33.49|73.776|||Regression, Linear|||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.||73.776|33.490|
71828891|NCT01924767|143162282|SUPERIORITY_OR_OTHER||Geometric mean of ratio|37.632|||||TWO_SIDED|95.0|15.429|91.789|||Regression, Linear|||This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.||91.789|15.429|
71828892|NCT01924767|143162293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37645.43||||0.0067|TWO_SIDED|95.0|11021.57|64269.3||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.||The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||64269.30|11021.57|0.0067
71828893|NCT01924767|143162293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82898.2|||<|0.0001|TWO_SIDED|95.0|55344.83|110451.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||110451.6|55344.83|<0.0001
71828894|NCT01924767|143162293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79982.89|||<|0.0001|TWO_SIDED|95.0|53087.22|106878.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||106878.6|53087.22|<0.0001
71828895|NCT01924767|143162293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|91306.96|||<|0.0001|TWO_SIDED|95.0|64685.41|117928.5||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo was calculated|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).||117928.5|64685.41|<0.0001
71828896|NCT01924767|143162294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.456||||0.0449|TWO_SIDED|95.0|-30.543|-0.369||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.369|-30.543|0.0449
71828897|NCT01924767|143162294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.467||||0.0042|TWO_SIDED|95.0|-39.085|-7.848||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-7.848|-39.085|0.0042
71656926|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.02|||||TWO_SIDED|95.0|-0.1|0.14|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A||0.14|-0.10|
71656927|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.03|||||TWO_SIDED|95.0|-0.1|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.15|-0.10|
71656928|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.07|-0.17|
71656929|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.08|||||TWO_SIDED|95.0|-0.2|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F||0.05|-0.20|
71656930|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|0.01|||||TWO_SIDED|95.0|-0.11|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.13|-0.11|
71656931|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.02|||||TWO_SIDED|95.0|-0.14|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.10|-0.14|
71656932|NCT00444457|142831454|SUPERIORITY_OR_OTHER||Difference in log-transformed GM|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A||0.08|-0.15|
71656933|NCT00321737|142831465|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71656934|NCT00321737|142831465|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71768027|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.371||0.244|TWO_SIDED|95.0|-1.163|0.296||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.296|-1.163|0.244
71768028|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.15|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768029|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.36||0.085|TWO_SIDED|95.0|-1.33|0.086||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.086|-1.330|0.085
71768030|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.21|STANDARD_DEVIATION|3.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768031|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.371||0.137|TWO_SIDED|95.0|-1.28|0.177||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.177|-1.280|0.137
71768032|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.19|STANDARD_DEVIATION|2.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828898|NCT01924767|143162294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.956||||0.0521|TWO_SIDED|95.0|-30.057|0.145||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||0.145|-30.057|0.0521
71828899|NCT01924767|143162294|SUPERIORITY_OR_OTHER||Difference to placebo|-10.602||||0.1676|TWO_SIDED|95.0|-25.848|4.644||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.644|-25.848|0.1676
71717005|NCT01815424|142948390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|70.31|||<|0.0001|TWO_SIDED|95.0|13.38|267.15||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||267.15|13.38|<0.0001
71768033|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.352||0.258|TWO_SIDED|95.0|-0.294|1.091||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.091|-0.294|0.258
71768034|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71887171|NCT01808612|143294755|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.264|TWO_SIDED|95.0|-0.55|2.0|||Mixed Models Analysis|||Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.||2.00|-0.55|0.264
71768035|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.348||0.711|TWO_SIDED|95.0|-0.555|0.814||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.814|-0.555|0.711
71768036|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|3.05|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768037|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.35||0.503|TWO_SIDED|95.0|-0.454|0.924||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.924|-0.454|0.503
71768038|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768039|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.404||0.978|TWO_SIDED|95.0|-0.806|0.784||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.784|-0.806|0.978
71768040|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768041|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.402||0.265|TWO_SIDED|95.0|-1.239|0.342||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.342|-1.239|0.265
71768042|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828900|NCT01924767|143162295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.269||||0.2239|TWO_SIDED|95.0|-19.162|4.624||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||4.624|-19.162|0.2239
71887172|NCT04823949|143294762|OTHER||Risk Ratio (RR)|1.59|||<|0.001|TWO_SIDED|95.0|1.33|1.88|||Chi-squared|||||1.88|1.33|<0.001
71887173|NCT04823949|143294763|OTHER||Risk Ratio (RR)|1.35||||0.53|TWO_SIDED|95.0|0.52|3.49|||Fisher Exact|||||3.49|0.52|.530
71656935|NCT00321737|142831465|SUPERIORITY_OR_OTHER||||||>|0.99999||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||>0.99999
71656936|NCT00321737|142831466|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71656937|NCT00321737|142831466|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71656938|NCT00321737|142831466|SUPERIORITY_OR_OTHER|||||||0.0673||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.06730
71656939|NCT00321737|142831468|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71656940|NCT00321737|142831468|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71656941|NCT00321737|142831468|SUPERIORITY_OR_OTHER|||||||0.13932||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.13932
71656942|NCT00321737|142831469|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71656943|NCT00321737|142831469|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71656944|NCT00321737|142831469|SUPERIORITY_OR_OTHER|||||||0.11257||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.11257
71656945|NCT01769339|142831475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71656946|NCT00290251|142831477|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|performed on log-transformed delta change in total fibroid volume from baseline to end of treatment||||||0.43
71656947|NCT00290251|142831477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|95.0|||||ANOVA|Performed on log-transformed delta change||Ulipristal acetate groups one and two were first compared and found to be similar (see statistical analysis 1), so they were combined into a single treatment group for comparison to placebo group||||0.003
71656948|NCT00290251|142831478|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||The Delta of scores from treatment end to baseline was used to compare by ANOVA.|ANOVA|Adjustment for age||No sample size calculation was made.||||< 0.05
71656949|NCT03188666|142831522|SUPERIORITY||Least Square Mean Difference|-24.6||||0.0741|TWO_SIDED|95.0|-51.8|2.5|||ANCOVA|||||2.5|-51.8|0.0741
71656950|NCT03188666|142831523|SUPERIORITY||Least Square Mean Difference|-24.9||||0.3726|TWO_SIDED|95.0|-80.8|30.9|||Mixed Model with Repeated Measure (MMRM)|||||30.9|-80.8|0.3726
71656951|NCT03188666|142831524|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
71656952|NCT03188666|142831525|SUPERIORITY||Least Square Mean Difference|-25.6||||0.0756|TWO_SIDED|95.0|-53.9|2.8|||ANCOVA|||||2.8|-53.9|0.0756
71656953|NCT03188666|142831526|SUPERIORITY||Least Square Mean Difference|-27.8||||0.3407|TWO_SIDED|95.0|-86.1|30.5|||Mixed Model with Repeated Measure (MMRM)|||||30.5|-86.1|0.3407
71656954|NCT03188666|142831527|SUPERIORITY||Least Square Mean Difference|-0.34||||0.2656|TWO_SIDED|95.0|-0.96|0.27|||ANCOVA|||||0.27|-0.96|0.2656
71656955|NCT03188666|142831528|SUPERIORITY||Least Square Mean Difference|-0.36||||0.2651|TWO_SIDED|95.0|-1.01|0.29|||ANCOVA|||||0.29|-1.01|0.2651
71656956|NCT03188666|142831535|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared number of new lesions per participant by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
71656957|NCT03188666|142831536|SUPERIORITY|||||||0.0027||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0027
71656958|NCT03188666|142831537|SUPERIORITY|||||||0.0047||||||Week 56 vs. Week 28|McNemar|||Compared percent of participants with new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0047
71656959|NCT03188666|142831540|SUPERIORITY|||||||0.3663||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.3663
71656960|NCT03188666|142831541|SUPERIORITY|||||||0.001||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.0010
71656961|NCT03188666|142831547|SUPERIORITY|||||||0.0039||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total new lesion volume per participant by CT at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0039
71656962|NCT03188666|142831548|SUPERIORITY|||||||0.0273||||||Week 56 vs. Week 28|Wilcoxon signed rank test|||Compared total lesion activity per participant in new lesions by PET at week 28 (relative to baseline) and week 56 (relative to week 28).||||0.0273
71656963|NCT03188666|142831549|SUPERIORITY|||||||0.2123||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.2123
71656964|NCT03188666|142831550|SUPERIORITY|||||||0.1528||||||Period 2 vs. Period 1|Wilcoxon signed rank test|||||||0.1528
71656965|NCT03696953|142831563|OTHER|t test comparing||||||0.05|||||||t-test, 2 sided|||||||0.05
71656966|NCT03696953|142831564|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71656967|NCT03696953|142831564|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
71717006|NCT01815424|142948390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.44|||<|0.0001|TWO_SIDED|95.0|4.31|79.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||79.62|4.31|<0.0001
71768043|NCT02880956|143037271|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.414||0.789|TWO_SIDED|95.0|-0.704|0.925||The statistical model: ADAS-Cog change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.925|-0.704|0.789
71828901|NCT01924767|143162295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.844||||0.0421||95.0|-25.205|-0.484||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||-0.484|-25.205|0.0421
71717007|NCT01815424|142948391|SUPERIORITY_OR_OTHER||Least square mean difference|-7.52|STANDARD_ERROR_OF_MEAN|0.913|<|0.0001|TWO_SIDED|95.0|-9.32|5.72||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||5.72|-9.32|<0.0001
71717008|NCT01815424|142948391|SUPERIORITY_OR_OTHER||Least square mean difference|-5.45|STANDARD_ERROR_OF_MEAN|0.907|<|0.0001|TWO_SIDED|95.0|-7.24|-3.67||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.67|-7.24|<0.0001
71717009|NCT01815424|142948392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.4|||<|0.0001|TWO_SIDED|95.0|8.95|2657.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.||2657.62|8.95|<0.0001
71717010|NCT01815424|142948392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.37|||<|0.0001|TWO_SIDED|95.0|3.47|1084.02||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||1084.02|3.47|<0.0001
71717011|NCT01815424|142948393|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||<0.0001
71717012|NCT01815424|142948393|SUPERIORITY_OR_OTHER|||||||0.0386||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||||0.0386
71768044|NCT02880956|143037271|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|2.82|||TWO_SIDED|||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.||||
71768045|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.6||0.72|TWO_SIDED|95.0|-0.965|1.395||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.395|-0.965|0.720
71887174|NCT04823949|143294764|OTHER||Risk Ratio (RR)|2.53||||0.059|TWO_SIDED|95.0|0.92|6.9|||Fisher Exact|||||6.90|0.92|.059
71887175|NCT04823949|143294765|OTHER||Risk Ratio (RR)|0.84||||0.792|TWO_SIDED|95.0|0.23|3.04|||Fisher Exact|||||3.04|0.23|.792
71828902|NCT01924767|143162295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.719||||0.6527|TWO_SIDED|95.0|-14.842|9.403||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||9.403|-14.842|0.6527
71828903|NCT01924767|143162295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.998||||0.1318|TWO_SIDED|95.0|-20.818|2.822||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8||2.822|-20.818|0.1318
71828904|NCT00723450|143162298|SUPERIORITY_OR_OTHER|||||||0.0717||95.0|||||Log Rank|A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.||||||0.0717
71887176|NCT04823949|143294766|OTHER||Risk Ratio (RR)|1.11||||0.21|TWO_SIDED|95.0|0.94|1.31|||Chi-squared|||||1.31|0.94|.210
71887177|NCT01700192|143294767|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Wilcoxon (Mann-Whitney)|||||-0.40|-1.20|<0.001
71717013|NCT01815424|142948394|SUPERIORITY_OR_OTHER||Least square mean difference|-5.09|STANDARD_ERROR_OF_MEAN|0.709|<|0.0001|TWO_SIDED|95.0|-6.49|-3.7||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-3.70|-6.49|<0.0001
71717014|NCT01815424|142948394|SUPERIORITY_OR_OTHER||Least square mean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|-5.59|-2.81||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-2.81|-5.59|<0.0001
71717015|NCT01815424|142948395|SUPERIORITY_OR_OTHER||Least square mean of difference|-41.23|STANDARD_ERROR_OF_MEAN|15.977||0.0113|TWO_SIDED|95.0|-72.91|-9.54||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||-9.54|-72.91|0.0113
71717016|NCT01815424|142948395|SUPERIORITY_OR_OTHER||Least square mean of difference|-22.89|STANDARD_ERROR_OF_MEAN|16.01||0.1558|TWO_SIDED|95.0|-54.64|8.86||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.||8.86|-54.64|0.1558
71717017|NCT00328172|142948510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3271||95.0|-0.41|0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 0.5 mg versus placebo||0.14|-0.41|0.3271
71717018|NCT00328172|142948510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0032||95.0|-0.69|-0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 2.5 mg versus placebo||-0.14|-0.69|0.0032
71717019|NCT00328172|142948510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0012||95.0|-0.74|-0.18|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.18|-0.74|0.0012
71717020|NCT00328172|142948510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.1|-0.59|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Metformin versus placebo||-0.59|-1.1|<0.0001
71828905|NCT00612586|143162320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956||||||One sided|Log Rank|||||||0.8956
71828906|NCT00612586|143162321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9865||||||One-sided|Log Rank|||||||0.9865
71828907|NCT05565391|143162362|OTHER||Risk Ratio (RR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.54|2.47|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.47|1.54|<.0001
71887178|NCT01700192|143294767|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-17.2|||||TWO_SIDED|95.0|-25.0|-9.7||||||||-9.7|-25.0|
71887179|NCT01700192|143294770|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Wilcoxon (Mann-Whitney)|||||-0.30|-1.00|<0.001
71887180|NCT01700192|143294770|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-15.5|||||TWO_SIDED|95.0|-24.4|-7.3||||||||-7.3|-24.4|
71887181|NCT01700192|143294771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.154|TWO_SIDED|95.0|-0.35|0.05|||Zero-inflated Log-normal Model|||||0.05|-0.35|0.154
71887182|NCT01700192|143294771|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-18.4|||||TWO_SIDED|95.0|-41.0|4.3||||||||4.3|-41|
71768046|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|4.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828908|NCT05565391|143162362|OTHER||Risk Ratio (RR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.52|2.67|||Log-binomial regression model||Unweighted RRs were estimated using a log-binomial regression model with Wald confidence intervals.|||2.67|1.52|<.0001
71828909|NCT05565391|143162363|OTHER||Risk Ratio (RR)|2.22|||<|0.0001|TWO_SIDED|95.0|1.69|2.9|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||2.90|1.69|<.0001
71656968|NCT03696953|142831565|OTHER|T test||||||0.01|||||||t-test, 2 sided|||Comparison of 36 week AP-GI-SA Scores between probiotic and placebo groups at 36 weeks||||0.01
71768047|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.592||0.455|TWO_SIDED|95.0|-1.607|0.722||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.722|-1.607|0.455
71828910|NCT05565391|143162364|OTHER||Risk Ratio (RR)|1.79||||0.0447|TWO_SIDED|95.0|1.01|3.15|||Log-binomial regression model||Risk ratio was estimated using a log-binomial regression model and confidence interval was estimated using robust error variance.|||3.15|1.01|0.0447
71828911|NCT05565391|143162365|OTHER|||||||0.4241|||||||Quantile regression|||||||0.4241
71828912|NCT05565391|143162365|OTHER|||||||0.0281|||||||Quantile regression|||||||0.0281
71828913|NCT05565391|143162366|OTHER|||||||0.7682|||||||Quantile regression|||||||0.7682
71828914|NCT05565391|143162367|OTHER|||||||0.0326|||||||Quantile regression|||||||0.0326
71828915|NCT05565391|143162368|OTHER||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.31|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.31|0.09|<.0001
71828916|NCT05565391|143162368|OTHER||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.11|0.43|||Cox proportional hazard model||Hazard ratio was estimated using unadjusted Cox proportional hazard model.|||0.43|0.11|<.0001
71828917|NCT05565391|143162369|OTHER||Hazard Ratio (HR)|0.11|||<|0.0001|TWO_SIDED|95.0|0.06|0.22|||Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.22|0.06|<.0001
71828918|NCT05565391|143162370|OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.1|0.45|||Weighted Cox proportional hazard model||Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.|||0.45|0.10|<.0001
71828919|NCT02716324|143162371|SUPERIORITY||Beta Coefficient|0.001||||0.871|TWO_SIDED|95.0|-0.01|0.012|||GLS random-effects model|||Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.012|-0.010|.871
71828920|NCT02716324|143162372|SUPERIORITY||Beta coefficient|0.001||||0.499|TWO_SIDED|95.0|-0.002|0.004|||Random effects model|||Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.||0.004|-0.002|0.499
71828921|NCT02716324|143162373|SUPERIORITY|||||||0.718|||||||Chi-squared|||Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.||||0.718
71828922|NCT02716324|143162373|SUPERIORITY|||||||0.903|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.||||0.903
71828923|NCT02716324|143162373|SUPERIORITY|||||||0.915|||||||Chi-squared|||Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.||||0.915
71828924|NCT02716324|143162374|SUPERIORITY|||||||0.31|||||||Chi-squared|||Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.||||0.310
71828925|NCT02716324|143162374|SUPERIORITY|||||||0.251|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.||||0.251
71828926|NCT02716324|143162374|SUPERIORITY|||||||1|||||||Chi-squared|||Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.||||1.00
71828927|NCT02716324|143162375|SUPERIORITY||Beta coefficient|0.0||||0.662|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.662
71656969|NCT03696953|142831566|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
71656970|NCT03696953|142831567|OTHER|T test||||||0.05|||||||t-test, 2 sided|||||||0.05
71768048|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71828928|NCT02716324|143162375|SUPERIORITY||Beta coefficient|0.001||||0.075|TWO_SIDED|95.0|0.0|0.002|||Random effects model|||Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.002|0.000|0.075
71828929|NCT02716324|143162376|SUPERIORITY||Beta coefficient|0.0||||0.707|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.707
71828930|NCT02716324|143162376|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
71828931|NCT02716324|143162377|SUPERIORITY||Beta coefficient|0.0||||0.735|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.735
71887183|NCT01700192|143294772|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6|||Wilcoxon (Mann-Whitney)|||||-0.60|-1.70|<0.001
71887184|NCT01700192|143294772|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.7|||||TWO_SIDED|95.0|-24.6|-4.0||||||||-4.0|-24.6|
71887185|NCT01700192|143294773|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Wilcoxon (Mann-Whitney)|||||-3.10|-9.10|<0.001
71656971|NCT06204887|142831586|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71656972|NCT00062010|142831636|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percentage|8.8|||||TWO_SIDED|90.0|2.4|21.3||||||The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.||21.3|2.4|
71656973|NCT02856880|142831639|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|40.18|||<|0.0001|TWO_SIDED|95.0|32.37|47.99||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque Glycolysis for the first named treatment.|||47.99|32.37|<0.0001
71656974|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|26.41|||<|0.0001|TWO_SIDED|95.0|18.94|33.88||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||33.88|18.94|<0.0001
71656975|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|-2.91||||0.4823|TWO_SIDED|95.0|-11.18|5.37||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment.|||5.37|-11.18|0.4823
71656976|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|10.86||||0.0072|TWO_SIDED|95.0|3.13|18.59||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||18.59|3.13|0.0072
71656977|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|13.77||||0.0009|TWO_SIDED|95.0|6.01|21.53||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||21.53|6.01|0.0009
71656978|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|8.44||||0.0286|TWO_SIDED|95.0|0.93|15.95||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||15.95|0.93|0.0286
71656979|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|5.32||||0.1573|TWO_SIDED|95.0|-2.15|12.79||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||12.79|-2.15|0.1573
71656980|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|-29.32|||<|0.0001|TWO_SIDED|95.0|-37.2|-21.43||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||-21.43|-37.20|<0.0001
71656981|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|31.74|||<|0.0001|TWO_SIDED|95.0|24.18|39.3||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||39.30|24.18|<0.0001
71656982|NCT02856880|142831640|SUPERIORITY_OR_OTHER||LS mean difference|2.42||||0.5174|TWO_SIDED|95.0|-5.08|9.92||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.|||9.92|-5.08|0.5174
71717021|NCT00328172|142948511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.7027||95.0|-10.0|15.1|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 0.5 mg versus placebo||15.1|-10|0.7027
71717022|NCT00328172|142948511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.003||95.0|-32.0|-6.6|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 2.5 mg versus placebo||-6.6|-32|0.003
71717023|NCT00328172|142948511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.0418||95.0|-26.0|-0.5|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.5|-26|0.0418
71717024|NCT00328172|142948511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.3|||<|0.0001||95.0|-47.0|-22.0|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||||-22|-47|< 0.0001
71768049|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|0.43|STANDARD_ERROR_OF_MEAN|0.605||0.473|TWO_SIDED|95.0|-0.755|1.625||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.625|-0.755|0.473
71768050|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768051|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.686||0.813|TWO_SIDED|95.0|-1.187|1.512||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.512|-1.187|0.813
71768052|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|5.3|||TWO_SIDED|||||||||Week 48||||
71828932|NCT02716324|143162378|SUPERIORITY||Beta coefficient|0.0||||0.873|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.873
71887186|NCT01700192|143294773|SUPERIORITY_OR_OTHER||Treatment Difference Relative to Placebo|-16.0|||||TWO_SIDED|95.0|-22.7|-8.3||||||||-8.3|-22.7|
71717025|NCT00328172|142948512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.735||||0.413||95.0|0.464|6.492|||Regression, Logistic|||Linagliptin 0.5 mg versus placebo||6.492|0.464|0.413
71717026|NCT00328172|142948512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.157||||0.842||95.0|0.275|4.861|||Regression, Logistic|||Linagliptin 2.5 mg versus placebo||4.861|0.275|0.842
71717027|NCT00328172|142948512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.364||95.0|0.492|6.91|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||6.910|0.492|0.364
71717028|NCT00328172|142948512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.224||||0.005||95.0|1.648|16.562|||Regression, Logistic|||Metformin versus placebo||16.562|1.648|0.005
71717029|NCT01990742|142948522|OTHER||||||>|0.05|||||||MOnte carlo simulation|||||||>0.05
71717030|NCT01990742|142948523|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
71717031|NCT01990742|142948524|OTHER||||||>|0.05|||||||Monte carlo simulation|||||||>0.05
71717032|NCT02261961|142948537|SUPERIORITY||Slope|-0.24275|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71768053|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.672||0.421|TWO_SIDED|95.0|-1.863|0.78||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.780|-1.863|0.421
71768054|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|5.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768055|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.687||0.758|TWO_SIDED|95.0|-1.139|1.564||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.564|-1.139|0.758
71768056|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|5.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768057|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.815||0.511|TWO_SIDED|95.0|-2.14|1.066||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-2.140|0.511
71717033|NCT02261961|142948538|SUPERIORITY||Slope|1.3707|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717034|NCT02261961|142948541|SUPERIORITY||Slope|-0.35579|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717035|NCT02261961|142948542|SUPERIORITY||Slope|0.004493|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717036|NCT02261961|142948543|SUPERIORITY||Slope|0.870653|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717037|NCT02261961|142948544|SUPERIORITY||Slope|-0.38664|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71768058|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|6.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768059|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.801||0.192|TWO_SIDED|95.0|-2.623|0.527||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.527|-2.623|0.192
71768060|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|6.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71887187|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-79.456|STANDARD_ERROR_OF_MEAN|0.0819|<|0.0001|TWO_SIDED|80.0|-81.56|-77.11|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.11|-81.56|<0.0001
71717038|NCT02261961|142948545|SUPERIORITY||Slope|0.335124|||>|0.05|TWO_SIDED||||||ANCOVA|||Outcomes were compared as percent change from the baseline measure using multiple methods by a blinded statistician. Differences between groups were assessed using ANCOVA, Welch's t-test, and Wilcoxon. No significant differences were found between groups for any outcome regardless of method used.||||>0.05
71717039|NCT02261961|142948547|SUPERIORITY||Slope|0.03145|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717040|NCT02261961|142948548|SUPERIORITY||Slope|-0.43902|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717041|NCT02261961|142948558|SUPERIORITY||Slope|-0.07603|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71768061|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|0.69|STANDARD_ERROR_OF_MEAN|0.816||0.398|TWO_SIDED|95.0|-0.914|2.294||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.294|-0.914|0.398
71768062|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|5.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768063|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|0.97|STANDARD_ERROR_OF_MEAN|0.924||0.296|TWO_SIDED|95.0|-0.851|2.784||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.784|-0.851|0.296
71768064|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|6.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71717042|NCT02261961|142948577|SUPERIORITY||Slope|-0.4745|||>|0.05|TWO_SIDED||||||ANCOVA|||||||>0.05
71717043|NCT01365793|142948615|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.34||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to \<14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.||||0.34
71717044|NCT01365793|142948615|SUPERIORITY|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.43||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to \<14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.||||0.43
71717045|NCT01469039|142948633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71717046|NCT01469039|142948633|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71717047|NCT01469039|142948634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
71717048|NCT01469039|142948634|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF|||||||<0.001
71717049|NCT04828707|142948647|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||"The Intent-To-Treat (ITT) dataset was used for primary outcome. To overcome impact of missing data, statistical analysis was conducted using the Last Observation Carried Forward (LOCF) as an imputation method.~The data of each variable collected from the daily diary was normalized to 28 days for every period (weeks 1-4, weeks 5-8, and weeks 9-12).~Participants' data who entered the treatment phase but dropped out during weeks 5-8 were carried forward and analyzed as their data at weeks 9-12."||||<0.05
71768065|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.907||0.706|TWO_SIDED|95.0|-2.126|1.442||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.442|-2.126|0.706
71768066|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|6.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768067|NCT02880956|143037272|SUPERIORITY||LS Mean of Difference|1.79|STANDARD_ERROR_OF_MEAN|0.929||0.055|TWO_SIDED|95.0|-0.036|3.617||The statistical model: FAQ change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||3.617|-0.036|0.055
71768068|NCT02880956|143037272|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|6.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768069|NCT02880956|143037273|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.651|TWO_SIDED|95.0|-0.266|0.166||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.166|-0.266|0.651
71768070|NCT02880956|143037273|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|0.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71887188|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-87.403|STANDARD_ERROR_OF_MEAN|0.0887|<|0.0001|TWO_SIDED|80.0|-88.8|-85.84|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-85.84|-88.80|<0.0001
71717050|NCT00523978|142948671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is the success rate in experimental group is less than and equal to the one in control group. This comparison of the rates was performed using a 2-sided Fisher's Exact. A sample size of 240(160 experimental and 80 control) is required to provide 80% power to detect the treatment difference using a 2-sided (alpha = 0.05)Fisher's Exact Test of binomial proportions assuming the success rate was 40% for control and 60% for treatment.||||<0.0001
71768071|NCT02880956|143037273|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.107||0.32|TWO_SIDED|95.0|-0.318|0.104||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.104|-0.318|0.320
71717051|NCT00523978|142948672|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin was selected based on literature review.|||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is the proportion of subjects free from MAFE in the experimental group is inferior to that in the control group using 10% non-inferiority margin.A sample size of 160 evaluable cryoablation and 80 control subjects (one-sided α = 0.05, 2:1 randomization) was required to provide 80% power assuming the rate of free from MAFE at 12 months 80.5 and 77% in experimental and control groups respectively .||||<0.001
71717052|NCT00523978|142948673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||The test hypothesis is UCBExperimental\_CPE ≥ 14.8% vs UCBExperimental\_CPE \< 14.8%.The performance goal 14.8% was chosen based on a review of SSEDs for similar types of ablation trials.The expected rate for CPEs in a well-monitored trial of left atrial RF ablation for AF was estimated to be 10% (corresponding to a CPE-free rate of 90%).In a trial with 160 subject, the resulting one-sided 95% upper confidence bound would be 14.8%.||||<0.001
71717053|NCT00696878|142948674|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.4|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.4||
71717054|NCT00696878|142948674|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||0.8|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||0.8||
71717055|NCT00696878|142948674|SUPERIORITY_OR_OTHER_LEGACY||Percentage with immunogenicity|0.0|||||ONE_SIDED|95.0||1.5|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.||1.5||
71717056|NCT00940602|142948750|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.636||||0.015|TWO_SIDED|95.0|0.42|0.96||Exploratory p-value is one tailed and is based on the stratified log-rank test.|Regression, Cox||95% CI was based on a Wald test from Cox model|||0.96|0.42|0.015
71717057|NCT00940602|142948751|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|12.0|||||TWO_SIDED|95.0|-1.8|25.7||||||||25.7|-1.8|
71717058|NCT00940602|142948752|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.832||||0.2|TWO_SIDED|95.0|0.54|1.28|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.28|0.54|0.200
71717059|NCT00940602|142948753|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-5.3|8.1||||||||8.1|-5.3|
71717060|NCT00940602|142948754|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-0.3|||||TWO_SIDED|95.0|-12.0|11.4||||||||11.4|-12.0|
71717061|NCT00940602|142948755|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.725||||0.184|TWO_SIDED|95.0|0.36|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.36|0.184
71717062|NCT00940602|142948756|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.195|||<|0.001|TWO_SIDED|95.0|0.11|0.36|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||0.36|0.11|<.001
71717063|NCT00940602|142948757|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.871||||0.303|TWO_SIDED|95.0|0.52|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.52|0.303
71717064|NCT00940602|142948758|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|1.072||||0.389|TWO_SIDED|95.0|0.66|1.75|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.75|0.66|0.389
71717065|NCT00940602|142948760|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.5|||||TWO_SIDED|95.0|-5.2|8.1||||||||8.1|-5.2|
71717066|NCT00940602|142948761|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|0.7|||||TWO_SIDED|95.0|-1.6|3.0||||||||3.0|-1.6|
71768072|NCT02880956|143037273|SUPERIORITY||Effect size/pooled SD|0.13|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71887189|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-83.83|STANDARD_ERROR_OF_MEAN|0.0905|<|0.0001|TWO_SIDED|80.0|-85.65|-81.78|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.78|-85.65|<0.0001
71887190|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-92.138|STANDARD_ERROR_OF_MEAN|0.1041|<|0.0001|TWO_SIDED|80.0|-93.15|-90.98|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-90.98|-93.15|<0.0001
71887191|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-84.814|STANDARD_ERROR_OF_MEAN|0.0971|<|0.0001|TWO_SIDED|80.0|-86.64|-82.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-82.74|-86.64|<0.0001
71887192|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-92.87|STANDARD_ERROR_OF_MEAN|0.1114|<|0.0001|TWO_SIDED|80.0|-93.85|-91.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-91.74|-93.85|<0.0001
71887193|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-79.465|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|80.0|-81.69|-76.96|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.96|-81.69|<0.0001
71887194|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-88.711|STANDARD_ERROR_OF_MEAN|0.0963|<|0.0001|TWO_SIDED|80.0|-90.06|-87.18|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-87.18|-90.06|<0.0001
71887195|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-78.936|STANDARD_ERROR_OF_MEAN|0.0824|<|0.0001|TWO_SIDED|80.0|-81.11|-76.52|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-76.52|-81.11|<0.0001
71717067|NCT00940602|142948762|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|1.4|||||TWO_SIDED|95.0|-11.9|14.6||||||||14.6|-11.9|
71717068|NCT00940602|142948763|OTHER|100 (1-α)% confidence intervals with α of 0.05 are provided|Wilson score test|-9.6|||||TWO_SIDED|95.0|-20.8|1.6||||||||1.6|-20.8|
71717069|NCT00940602|142948764|OTHER|The study was not designed for confirmatory analyses. Statistical tests were performed in an exploratory sense only.|Hazard Ratio (HR)|0.797||||0.232|TWO_SIDED|95.0|0.43|1.46|||Regression, Cox||95% CI was based on a Wald test from Cox model.|||1.46|0.43|0.232
71717070|NCT01120405|142948766|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.|Difference of proportion|0.19||||0.0052|TWO_SIDED|95.0|-6.7|7.07|||Difference of proportion|||"The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc \< 10%.~As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included."||7.07|-6.70|0.0052
71717071|NCT01120405|142948767|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.7715|TWO_SIDED|95.0|-3.9|5.25|||Difference of proportion|||||5.25|-3.90|0.7715
71887196|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-86.28|STANDARD_ERROR_OF_MEAN|0.0899|<|0.0001|TWO_SIDED|80.0|-87.82|-84.55|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.55|-87.82|<0.0001
71717072|NCT01120405|142948768|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.4763|TWO_SIDED|95.0|-1.19|2.54|||Difference of proportion|||||2.54|-1.19|0.4763
71717073|NCT01120405|142948769|SUPERIORITY_OR_OTHER||Difference of proportion|-0.34||||0.6533|TWO_SIDED|95.0|-1.82|1.14|||Difference of proportion|||||1.14|-1.82|0.6533
71717074|NCT01120405|142948770|SUPERIORITY_OR_OTHER||Difference of proportion|0.68||||0.1559|TWO_SIDED|95.0|-0.26|1.61|||Difference of proportion|||||1.61|-0.26|0.1559
71717075|NCT01120405|142948772|SUPERIORITY_OR_OTHER||Difference of proportion|1.69||||0.6056|TWO_SIDED|95.0|-4.74|8.13|||Difference of proportion|||||8.13|-4.74|0.6056
71717076|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Comparison among three groups over 4 weeks of treatment||||0.238
71717077|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.004|||||||Kruskal-Wallis|||Comparison among three groups at the 4th week of follow-up||||0.004
71717078|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.277|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.277
71717079|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.001
71887197|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-79.648|STANDARD_ERROR_OF_MEAN|0.0664|<|0.0001|TWO_SIDED|80.0|-81.36|-77.78|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-77.78|-81.36|<0.0001
71887198|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-84.985|STANDARD_ERROR_OF_MEAN|0.0715|<|0.0001|TWO_SIDED|80.0|-86.34|-83.5|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-83.50|-86.34|<0.0001
71887199|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|72.893|STANDARD_ERROR_OF_MEAN|0.0809|<|0.0001|TWO_SIDED|80.0|55.37|92.4|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||92.40|55.37|<0.0001
71887200|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|98.049|STANDARD_ERROR_OF_MEAN|0.0897|<|0.0001|TWO_SIDED|80.0|75.92|122.96|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||122.96|75.92|<0.0001
71887201|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-80.164|STANDARD_ERROR_OF_MEAN|0.0668|<|0.0001|TWO_SIDED|80.0|-81.84|-78.33|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-78.33|-81.84|<0.0001
71887202|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-83.381|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|80.0|-84.92|-81.69|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-81.69|-84.92|<0.0001
71887203|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-78.408|STANDARD_ERROR_OF_MEAN|0.0602|<|0.0001|TWO_SIDED|80.0|-80.06|-76.62|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate||-76.62|-80.06|<0.0001
71717080|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.055|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up||||0.055
71717081|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison among three groups at the 12th week of follow-up||||0.001
71717082|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.33|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.330
71717083|NCT00508482|142948795|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||<0.001
71717084|NCT00508482|142948795|SUPERIORITY_OR_OTHER|||||||0.018|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up||||0.018
71717085|NCT00508482|142948796|SUPERIORITY_OR_OTHER|||||||0.573|||||||ANOVA|||||||0.573
71717086|NCT00508482|142948797|SUPERIORITY_OR_OTHER|||||||0.271|||||||Kruskal-Wallis|||||||0.271
71717087|NCT00508482|142948798|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71717088|NCT00508482|142948798|SUPERIORITY_OR_OTHER|||||||0.58|||||||Least-Significant Difference|||||||0.580
71828933|NCT02716324|143162378|SUPERIORITY||Beta coefficient|0.0||||0.888|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.888
71887204|NCT02793232|143294833|SUPERIORITY||Percent change from baseline|-85.365|STANDARD_ERROR_OF_MEAN|0.0653|<|0.0001|TWO_SIDED|80.0|-86.57|-84.05|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.||-84.05|-86.57|<0.0001
71887205|NCT02551159|143294843|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.787|TWO_SIDED|95.0|0.69|1.32||2 sided|Log Rank|||Statistical analysis of number of deaths||1.32|0.69|0.787
71717089|NCT00508482|142948798|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
71717090|NCT00508482|142948798|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
71717091|NCT00508482|142948799|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANOVA|||||||0.167
71717092|NCT00508482|142948800|SUPERIORITY_OR_OTHER|||||||0.066|||||||Kruskal-Wallis|||||||0.066
71717093|NCT00508482|142948801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71717094|NCT00508482|142948801|SUPERIORITY_OR_OTHER|||||||0.024|||||||Least-Significant Difference|||||||0.024
71717095|NCT00508482|142948801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
71717096|NCT00508482|142948801|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Least-Significant Difference|||||||<0.001
71717097|NCT00508482|142948802|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71717098|NCT00508482|142948802|SUPERIORITY_OR_OTHER|||||||0.627||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.627
71717099|NCT00508482|142948802|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
71717100|NCT00508482|142948802|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
71717101|NCT00508482|142948803|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71717102|NCT00508482|142948803|SUPERIORITY_OR_OTHER|||||||0.587||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.587
71717103|NCT00508482|142948803|SUPERIORITY_OR_OTHER|||||||0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.001
71717104|NCT00508482|142948803|SUPERIORITY_OR_OTHER||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||<0.001
71717105|NCT00508482|142948804|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
71717106|NCT00508482|142948804|SUPERIORITY_OR_OTHER|||||||0.507||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.507
71717107|NCT00508482|142948804|SUPERIORITY_OR_OTHER|||||||0.005||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.005
71717108|NCT00508482|142948804|SUPERIORITY_OR_OTHER|||||||0.008||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared|||||||0.008
71717109|NCT02289469|142948805|SUPERIORITY||Mean Difference (Final Values)|23.8|||<|0.0001|TWO_SIDED|95.0|16.0|31.6|||Chi-squared|||A chi-square test was used to test for differences in proportions between intervention and control groups.||31.6|16.0|<0.0001
71717110|NCT02289469|142948806|OTHER||||||<|0.01|||||||Other|||Descriptive statistics (counts, frequencies) were used to summarize responses.||||<0.01
71717111|NCT00587041|142948807|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||80% power for 0.66 DG difference from placebo. The reported value is the overall p-value for CaOx supersaturation by Kruskal-Wallis test of equal change across all three groups, no pair-wise comparison.||||0.3
71717112|NCT00587041|142948807|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 1 sided|||Ranked sum T-test for placebo group CaOx SS comparison between 0 and 6 weeks||||0.045
71717113|NCT00587041|142948807|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 1 sided|||Ranked sum T-test for AKSB group CaOX SS comparison between 0 and 6 weeks||||0.67
71717114|NCT00587041|142948807|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 1 sided|||Ranked-sum T-Test for Oxadrop group CaOX SS comparison between 0 and 6 weeks||||0.30
71717115|NCT01628523|142948829|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71717116|NCT03623698|142948843|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-4.0|-1.5|||Wilcoxon (Mann-Whitney)|||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.500|-4.000|<0.001
71717117|NCT03623698|142948843|OTHER|Linear mixed-effects model|Restricted Maximum Likelihood (REML)|-2.88||||0.001|TWO_SIDED|95.0|-4.46|-1.29||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, mechanical ventilation, tracheostomy, gastrostomy, non-ambulant.||"Statistical analysis was performed using IBM SPSS Statistics software, version 25.~This analysis applies to the category of Total courses of antibiotics."||-1.29|-4.46|0.001
71828934|NCT02716324|143162379|SUPERIORITY||Beta coefficient|0.0||||0.679|TWO_SIDED|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p\<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.||0.001|-0.001|0.679
71717118|NCT03623698|142948844|OTHER||Median Difference (Final Values)|-1.0||||0.001|TWO_SIDED|95.0|-1.5|-0.5|||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.50|-1.50|0.001
71717119|NCT03623698|142948844|OTHER||Restricted Maximum Likelihood (REML)|-1.02|||<|0.001|TWO_SIDED|95.0|-1.53|-0.52||95% confidence interval, significance level p-values \<0.05. Random effects pre-defined from theory and published data, and AIC was were used to define the best model. Outcome measures: Courses of antibiotics; Fixed effect: nebulised saline treatment.|Mixed Models Analysis|Random effects: age, gender, prolonged mechanical ventilation (nasal or tracheostomy), and antibiotic prophylaxis||Statistical analysis was performed using IBM SPSS Statistics software, version 25.||-0.52|-1.53|<0.001
71717120|NCT03623698|142948847|OTHER||Median Difference (Final Values)|-4.5||||0.003|TWO_SIDED|95.0|-5.5|-3.0|||Wilcoxon (Mann-Whitney)|||||-3.00|-5.50|0.003
71717121|NCT03623698|142948848|OTHER||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-2.0|||Wilcoxon (Mann-Whitney)|||||-2.0|-2.5|<0.001
71717122|NCT03623698|142948851|OTHER||Mean Difference (Final Values)|0.17||||0.97|TWO_SIDED|95.0|-0.69|0.76|||Wilcoxon (Mann-Whitney)|||||0.76|-0.69|0.97
71828935|NCT02716324|143162380|SUPERIORITY||Beta coefficient|0.074||||0.495|TWO_SIDED|95.0|-0.164|0.311|||Random effects model|||Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.311|-0.164|0.495
71828936|NCT02716324|143162380|SUPERIORITY||Beta coefficient|-0.013||||0.885|TWO_SIDED|95.0|-0.217|0.191|||Random effects model|||Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.191|-0.217|0.885
71828937|NCT02716324|143162380|SUPERIORITY||Beta coefficient|0.073||||0.527|TWO_SIDED|95.0|-0.182|0.328|||Random effects model|||Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.328|-0.182|0.527
71828938|NCT02716324|143162380|SUPERIORITY||Beta coefficient|0.136||||0.285|TWO_SIDED|95.0|-0.138|0.41|||Random effects model|||Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.||0.410|-0.138|0.285
71828939|NCT00530842|143162381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.044||0.0482|TWO_SIDED|95.0|-0.174|-0.001|||ANOVA|ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.||||-0.001|-0.174|0.0482
71717123|NCT03623698|142948852|OTHER||Mean Difference (Final Values)|-1.47||||0.09|TWO_SIDED|95.0|-3.26|0.34|||Wilcoxon (Mann-Whitney)|||||0.34|-3.26|0.09
71717124|NCT03623698|142948853|OTHER||Mean Difference (Final Values)|-0.08||||0.65|TWO_SIDED|95.0|-0.38|0.38|||Wilcoxon (Mann-Whitney)|||||0.38|-0.38|0.65
71717125|NCT00811954|142948858|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|3.4|||||TWO_SIDED|97.5|-0.7|7.4||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||7.4|-0.7|
71717126|NCT00811954|142948858|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|5.6|||||TWO_SIDED|97.5|1.3|9.9||||||Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||9.9|1.3|
71717127|NCT00811954|142948858|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|-2.2|||||TWO_SIDED|97.5|-6.7|2.3||||||Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.||2.3|-6.7|
71768073|NCT02880956|143037273|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.757|TWO_SIDED|95.0|-0.25|0.182||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.182|-0.250|0.757
71828940|NCT00530842|143162382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0||||0.3407|TWO_SIDED|95.0|-9.5|27.5|||Wilcoxon signed-rank test||The confidence interval was determined by Hodges-Lehmann method.|||27.5|-9.5|0.3407
71828941|NCT01184508|143162440|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference (Net)|-1.03||||0.085|TWO_SIDED|90.0|-2.02|-0.05||The comparison between LY2300559 and placebo for the LS mean change from baseline to Month 3 in the number of migraine attacks was conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||-0.05|-2.02|0.085
71717128|NCT00811954|142948859|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|12.8|||||TWO_SIDED|97.5|9.4|16.1||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||16.1|9.4|
71717129|NCT00811954|142948859|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|3.6|||||TWO_SIDED|97.5|1.4|5.8||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.||5.8|1.4|
71717130|NCT00811954|142948859|NON_INFERIORITY_OR_EQUIVALENCE|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|9.2|||||TWO_SIDED|97.5|5.5|12.9||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.||12.9|5.5|
71887206|NCT02551159|143294845|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.634|TWO_SIDED|95.0|0.8|1.39||2 sided|Log Rank|||||1.39|0.80|0.634
71887207|NCT02551159|143294847|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.287|TWO_SIDED|95.0|0.94|1.8||2 sided|Log Rank|||||1.80|0.94|0.287
71887208|NCT02551159|143294847|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.028|TWO_SIDED|95.0|0.99|1.76||2 sided|Log Rank|||||1.76|0.99|0.028
71717131|NCT05525910|142948914|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|105.03|||||TWO_SIDED|90.0|94.54|116.68||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||116.68|94.54|
71717132|NCT05525910|142948914|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.15|||||TWO_SIDED|90.0|98.08|121.47||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||121.47|98.08|
71717133|NCT05525910|142948914|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.72|||||TWO_SIDED|90.0|90.79|111.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.74|90.79|
71717134|NCT05525910|142948914|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|110.45|||||TWO_SIDED|90.0|99.58|122.52||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.52|99.58|
71717135|NCT05525910|142948915|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|104.86|||||TWO_SIDED|90.0|93.78|117.24||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||117.24|93.78|
71717136|NCT05525910|142948915|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.7|||||TWO_SIDED|90.0|97.93|122.89||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||122.89|97.93|
71717137|NCT05525910|142948915|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|100.14|||||TWO_SIDED|90.0|89.69|111.8||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||111.80|89.69|
71717138|NCT05525910|142948915|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.8|||||TWO_SIDED|90.0|98.36|122.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||122.57|98.36|
71717139|NCT05525910|142948916|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.85|||||TWO_SIDED|90.0|94.97|127.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||127.06|94.97|
71768074|NCT02880956|143037273|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|0.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71887209|NCT02551159|143294848|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.001|TWO_SIDED|95.0|0.1|0.37||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.37|0.10|<0.001
71887210|NCT02551159|143294848|SUPERIORITY||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.2|0.57||2 sided|Regression, Logistic|||Statistical analysis of number with a response||0.57|0.20|<0.001
71887211|NCT02551159|143294850|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.811|TWO_SIDED|95.0|0.83|1.27||2 sided|Log Rank|||Statistical analysis of number of deaths||1.27|0.83|0.811
71887212|NCT02551159|143294850|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.624|TWO_SIDED|95.0|0.87|1.25|||Log Rank|||Statistical analysis of number of deaths||1.25|0.87|0.624
71887213|NCT02551159|143294853|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.006|TWO_SIDED|95.0|1.1|1.68||2 sided|Log Rank|||||1.68|1.10|0.006
71828942|NCT01184508|143162442|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|1.75||||0.77|TWO_SIDED|90.0|-8.27|11.76||The p-value is for the change from baseline to Month 3 in average duration of photophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||11.76|-8.27|0.770
71828943|NCT01184508|143162442|SUPERIORITY_OR_OTHER||LS mean difference|7.3||||0.276|TWO_SIDED|90.0|-3.91|18.52||The p-value is for the change from baseline to Month 3 in average duration of phonophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||18.52|-3.91|0.276
71828944|NCT01184508|143162442|SUPERIORITY_OR_OTHER||LS mean difference|-2.7||||0.606|TWO_SIDED|90.0|-11.51|6.1||The p-value is for the change from baseline to Month 3 in average duration of nausea.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||6.10|-11.51|0.606
71828945|NCT01184508|143162443|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.57||||0.174|TWO_SIDED|90.0|-3.48|0.34||The p-value is for the mean change from baseline to Month 3 in the number of migraine days.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group\*month, baseline, baseline\*month; Random effect: pts; Repeated effect: month.||||0.34|-3.48|0.174
71828946|NCT01184508|143162446|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.27||||0.963|TWO_SIDED|90.0|-9.76|9.23||The p-value is for the change from baseline to Week 12 in MSQ restrictive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||9.23|-9.76|0.963
71828947|NCT01184508|143162446|SUPERIORITY_OR_OTHER||LS mean difference|-2.17||||0.591|TWO_SIDED|90.0|-8.85|4.5||The p-value is for the change from baseline to Week 12 in MSQ preventive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||4.50|-8.85|0.591
71828948|NCT01184508|143162446|SUPERIORITY_OR_OTHER||LS mean difference|1.89||||0.72|TWO_SIDED|90.0|-6.81|10.58||The p-value is for the change from baseline to Week 12 in MSQ emotional function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group\*visit, baseline and baseline\*visit.||||10.58|-6.81|0.720
71828949|NCT01184508|143162447|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.25||||0.688|TWO_SIDED|90.0|-1.3|0.8||The p-value is for the change from baseline to Week 12 in MIBS-4 overall weighted score.|ANCOVA|Fixed effects: pooled investigator, treatment group, and baseline.||||0.80|-1.30|0.688
71828950|NCT01184508|143162449|SUPERIORITY_OR_OTHER|||||||0.607||95.0||||The p-value is for the percentage of participants using breakthrough medication at Month 3.|Fisher Exact|||||||0.607
71828951|NCT03684265|143162456|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|92.74|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|95.0|89.02|96.62|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-t. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||96.62|89.02|
71828952|NCT03684265|143162457|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|78.94|STANDARD_ERROR_OF_MEAN|14.57|||TWO_SIDED|90.0|73.7|84.56|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for Cmax. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||84.56|73.70|
71828953|NCT03684265|143162458|EQUIVALENCE|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|97.04|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|92.57|101.72|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-∞. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random||101.72|92.57|
71828954|NCT04707313|143162508|SUPERIORITY||Difference to placebo|-5.6|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-7.41|-3.74|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.74|-7.41|<.0001
71828955|NCT04707313|143162508|SUPERIORITY||Difference to placebo|-5.0|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-6.8|-3.16|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-3.16|-6.80|<.0001
71887214|NCT02551159|143294853|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.008|TWO_SIDED|95.0|1.06|1.53||2 sided|Log Rank|||||1.53|1.06|0.008
71887215|NCT02551159|143294854|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.33||2 sided|Regression, Logistic|||||0.33|0.13|<0.001
71887216|NCT02551159|143294854|SUPERIORITY||Odds Ratio (OR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41||2 sided|Regression, Logistic|||||0.41|0.20|<0.001
71887217|NCT00993928|143294862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q3: Percent change in sleep latency from baseline to week 7.||||0.85
71887218|NCT00993928|143294862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.||||0.86
71887219|NCT00993928|143294864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Chi-squared|||||||0.42
71887220|NCT00993928|143294866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||t-test, 2 sided|||Compare percent change from baseline to week 7 Distress Thermometer score.||||0.64
71717140|NCT05525910|142948916|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|114.69|||||TWO_SIDED|90.0|98.92|132.98||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||132.98|98.92|
71717141|NCT05525910|142948916|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|109.26|||||TWO_SIDED|90.0|94.64|126.14||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||126.14|94.64|
71717142|NCT05525910|142948916|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|115.98|||||TWO_SIDED|90.0|100.48|133.87||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||133.87|100.48|
71717143|NCT05525910|142948917|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|76.24|103.53||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.53|76.24|
71717144|NCT05525910|142948917|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|95.11|||||TWO_SIDED|90.0|81.41|111.11||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||111.11|81.41|
71717145|NCT05525910|142948917|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|85.74|||||TWO_SIDED|90.0|73.73|99.7||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.70|73.73|
71717146|NCT05525910|142948917|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|93.12|||||TWO_SIDED|90.0|80.09|108.26||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||108.26|80.09|
71717147|NCT05525910|142948918|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.43|||||TWO_SIDED|90.0|74.64|104.78||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||104.78|74.64|
71768075|NCT02880956|143037273|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.121||0.984|TWO_SIDED|95.0|-0.241|0.236||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.236|-0.241|0.984
71828956|NCT04707313|143162508|SUPERIORITY||Difference to Placebo|-9.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|90.0|-10.89|-7.28|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.28|-10.89|<.0001
71828957|NCT04707313|143162508|SUPERIORITY||Difference to Placebo|-6.6|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-8.75|-4.39|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.39|-8.75|<.0001
71717148|NCT05525910|142948918|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|96.0|||||TWO_SIDED|90.0|80.8|114.06||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||114.06|80.80|
71717149|NCT05525910|142948918|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|84.11|||||TWO_SIDED|90.0|71.15|99.43||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||99.43|71.15|
71717150|NCT05525910|142948918|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|90.99|||||TWO_SIDED|90.0|76.99|107.54||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||107.54|76.99|
71717151|NCT05525910|142948919|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|82.65|||||TWO_SIDED|90.0|65.85|103.74||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) Low Disintegrant||103.74|65.85|
71717152|NCT05525910|142948919|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|94.85|||||TWO_SIDED|90.0|75.28|119.49||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) High Disintegrant||119.49|75.28|
71717153|NCT05525910|142948919|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|81.56|||||TWO_SIDED|90.0|65.18|102.07||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 2\*(150/50 mg) HDL||102.07|65.18|
71768076|NCT02880956|143037273|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.85|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828958|NCT04707313|143162508|SUPERIORITY||Difference to Placebo|-9.52|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.43|-7.56|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.56|-11.43|<.0001
71828959|NCT04707313|143162508|SUPERIORITY||Difference to Placebo|-7.12|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|90.0|-9.41|-4.78|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.78|-9.41|<.0001
71887221|NCT04871711|143294867|SUPERIORITY||Risk Difference (RD)|9.8||||0.006|TWO_SIDED|95.0|3.6|16.1||5% significance level (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||16.1|3.6|0.006
71717154|NCT05525910|142948919|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|Ratio of Adjusted Geometric Means|88.38|||||TWO_SIDED|90.0|70.65|110.57||||||Reference: Nirmatrelvir/ritonavir 300(2\*150)/100 mg Test: Nirmatrelvir/ritonavir 3\*(100/33.3 mg)||110.57|70.65|
71717155|NCT02553629|142948954|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71717156|NCT02553629|142948955|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71717157|NCT02553629|142948956|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71717158|NCT02553629|142948957|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71717159|NCT02553629|142948958|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71717160|NCT01812057|142948959|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
71717161|NCT01812057|142948960|SUPERIORITY|Pain Score at rest at 2 hours||||||0.171|||||||t-test, 2 sided|||||||0.171
71717162|NCT01812057|142948960|SUPERIORITY|Pain Score with movement at 2 hours||||||0.204|||||||t-test, 2 sided|||||||0.204
71717163|NCT01812057|142948961|SUPERIORITY|||||||0.1965|||||||Log Rank|||||||0.1965
71717164|NCT01812057|142948962|SUPERIORITY|||||||0.709|||||||Wilcoxon (Mann-Whitney)|||||||0.709
71717165|NCT01812057|142948963|SUPERIORITY|Pain Score at rest at 24 hours||||||0.267|||||||Wilcoxon (Mann-Whitney)|||||||0.267
71717166|NCT01812057|142948963|SUPERIORITY|Pain Score with movement at 24 hours||||||0.518|||||||t-test, 2 sided|||||||0.518
71717167|NCT01812057|142948964|SUPERIORITY|Pain Score at rest at 48 hours||||||0.491|||||||Wilcoxon (Mann-Whitney)|||||||0.491
71717168|NCT01812057|142948964|SUPERIORITY|Pain Scores with movement at 48 hours||||||0.525|||||||Wilcoxon (Mann-Whitney)|||||||0.525
71717169|NCT01812057|142948965|SUPERIORITY|||||||0.355|||||||Wilcoxon (Mann-Whitney)|Total opioid consumption at 24 hours|||We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.|||0.355
71717170|NCT01812057|142948966|SUPERIORITY|||||||0.42|||||||Fisher Exact|Chronic pain at 8 weeks||||||0.420
71717171|NCT01812057|142948967|SUPERIORITY|||||||0.322|||||||Fisher Exact|||||||0.322
71717172|NCT01812057|142948968|SUPERIORITY|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||24 hour pain scores at rest between MTS groups|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.|||0.805
71717173|NCT01812057|142948968|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Pain scores on movement at 24h|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.|||1.000
71717174|NCT01812057|142948969|SUPERIORITY|Intraoperative nausea and vomiting||||||0.245|||||||Fisher Exact|||||||0.245
71717175|NCT01812057|142948969|SUPERIORITY|||||||0.676|||||||Chi-squared|Need for intraoperative antiemetics||||||0.676
71717176|NCT01812057|142948969|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71717177|NCT01812057|142948971|SUPERIORITY|||||||0.924|||||||Chi-squared|Incidence of postoperative pruritus||||||0.924
71717178|NCT01812057|142948972|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.700
71717179|NCT01812057|142948973|SUPERIORITY|||||||0.302|||||||Chi-squared|Incidence of PONV at 24 h||||||0.302
71717180|NCT01812057|142948973|SUPERIORITY|||||||0.028|||||||Chi-squared|Postoperative need for rescue antiemetic||||||0.028
71717181|NCT01812057|142948973|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71717182|NCT01812057|142948973|SUPERIORITY|||||||0.188|||||||Chi-squared|||||||0.188
71717183|NCT03937479|142949012|SUPERIORITY||LS mean difference|0.1242|STANDARD_ERROR_OF_MEAN|0.03691||0.0008|TWO_SIDED|95.0|0.0517|0.1968||The mixed model for repeated measures (MMRM) model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1968|0.0517|0.0008
71828960|NCT04707313|143162508|SUPERIORITY||Difference to Placebo|-9.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|90.0|-11.11|-7.08|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-7.08|-11.11|<.0001
71828961|NCT04707313|143162508|SUPERIORITY||Difference to Placebo|-7.18|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|90.0|-9.32|-4.99|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.99|-9.32|<.0001
71717184|NCT03937479|142949012|SUPERIORITY||LS mean difference|0.1072|STANDARD_ERROR_OF_MEAN|0.03703||0.004|TWO_SIDED|95.0|0.0344|0.18||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1800|0.0344|0.0040
71717185|NCT03937479|142949012|SUPERIORITY||LS mean difference|0.0912|STANDARD_ERROR_OF_MEAN|0.03723||0.0148|TWO_SIDED|95.0|0.018|0.1643||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1643|0.0180|0.0148
71717186|NCT03937479|142949012|SUPERIORITY||LS mean difference|0.0775|STANDARD_ERROR_OF_MEAN|0.03697||0.0368|TWO_SIDED|95.0|0.0048|0.1501||The MMRM model was used to model the change from baseline FEV1 to peak FEV1 using treatment, visit and treatment by visit interaction as fixed effect, patient as random effect and baseline FEV1 as the covariate.|MMRM||Estimates refer to the Week 4 from treatment by visit interaction.|Comparison was done using a closed testing procedure; testing began at the highest dose of RPL554 compared with placebo. If found statistically significant then the next highest dose was compared with placebo. This continued until a result was found to be non-significant or all RPL554 doses were compared with placebo.||0.1501|0.0048|0.0368
71717187|NCT01854528|142949042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.26|||<|0.001|TWO_SIDED|95.0|21.09|47.42|||Stratum adjusted Mantel-Haenszel|||P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.||47.42|21.09|<0.001
71717188|NCT01854528|142949043|SUPERIORITY_OR_OTHER||LS mean difference|8.64|||<|0.001|TWO_SIDED|95.0|5.43|11.85|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||11.85|5.43|<0.001
71768077|NCT02880956|143037273|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.118||0.595|TWO_SIDED|95.0|-0.296|0.17||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.170|-0.296|0.595
71828962|NCT04707313|143162509|SUPERIORITY||Difference to Placebo|-8.21|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.66|-4.63|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.63|-11.66|<.0001
71828963|NCT04707313|143162509|SUPERIORITY||Difference to placebo|-8.44|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-11.83|-4.92|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-4.92|-11.83|<.0001
71717189|NCT01854528|142949044|SUPERIORITY_OR_OTHER||LS mean difference|7.55|||<|0.001|TWO_SIDED|95.0|5.11|9.98|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.||9.98|5.11|<0.001
71717190|NCT01854528|142949045|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|54.7|||<|0.001|TWO_SIDED|95.0|6.9|435.1|||Regression, Logistic|||P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.||435.1|6.9|<0.001
71717191|NCT00811720|142949072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|0.75||0.002|TWO_SIDED|95.0|-3.81|-0.85|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.85|-3.81|0.002
71768078|NCT02880956|143037273|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|0.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768079|NCT02880956|143037273|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.122||0.67|TWO_SIDED|95.0|-0.187|0.291||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.291|-0.187|0.670
71717192|NCT00811720|142949073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-16.81|-5.11|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-5.11|-16.81|<0.001
71717193|NCT00811720|142949074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.039|TWO_SIDED|95.0|0.5|0.98|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.||0.98|0.50|0.039
71828964|NCT04707313|143162509|SUPERIORITY||Difference to Placebo|-12.87|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|90.0|-16.15|-9.47|||Mixed Models Analysis||MMRM:treatment,time,strata(female vs male),treatment-by-time interaction as fixed effect, natural log-transformed baseline as covariate,natural log-transformed baseline-by-time interaction with time fitted:repeated effect, participant:random effect.|||-9.47|-16.15|<.0001
71717194|NCT00811720|142949075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.16|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.16|-0.57|<0.001
71717195|NCT00811720|142949076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.15|-0.53|<0.001
71717196|NCT00811720|142949077|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.009|TWO_SIDED|95.0|0.8|0.97|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.97|0.80|0.009
71717197|NCT00811720|142949078|SUPERIORITY_OR_OTHER||Ratio to placebo|0.9||||0.011|TWO_SIDED|95.0|0.84|0.98|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||0.98|0.84|0.011
71828965|NCT04707313|143162522|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|7.37|||||TWO_SIDED|90.0|2.81|19.3||||||||19.30|2.81|
71828966|NCT04707313|143162522|SUPERIORITY||Odds Ratio (OR)|6.58|||||TWO_SIDED|90.0|2.62|16.53||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||16.53|2.62|
71717198|NCT02099084|142949124|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.74
71717199|NCT02099084|142949125|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 2-hours. Level of significance = .05||||0.20
71717200|NCT02099084|142949125|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 8-hours. Level of significance = .05||||0.17
71717201|NCT02099084|142949126|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.075
71717202|NCT02099084|142949129|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.42
71717203|NCT02099084|142949130|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Level of significance = .05||||0.34
71717204|NCT01205503|142949131|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).|Mixed Models Analysis|Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.||||||0.014
71717205|NCT01953211|142949140|SUPERIORITY_OR_OTHER||Slope|0.02|STANDARD_DEVIATION|0.57||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71717206|NCT01953211|142949140|SUPERIORITY_OR_OTHER||Slope|0.63|STANDARD_DEVIATION|0.9|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71717207|NCT01953211|142949140|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_DEVIATION|0.78|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71717208|NCT03188263|142949141|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.046||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.046
71717209|NCT03188263|142949142|OTHER|The primary planned analysis was in bright light group only and compared pre-post measurements.||||||0.35||||||A threshold of .05 was selected a priori.|Sign test|A Wilcoxon matched-pairs signed-ranks test was estimated to determine if pre-post measures of glucose levels differed significantly.||The primary planned analyses was to examine effect in bright light group. A significance level of .05 was selected a priori.||||.35
71717210|NCT00539240|142949162|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
71717211|NCT00539240|142949162|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
71717212|NCT00539240|142949163|SUPERIORITY_OR_OTHER|||||||0.19||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons (no post-hoc contrasts performed)|ANCOVA|Adjusted for baseline score and personality traits (SCL-90)||||||0.19
71717213|NCT00539240|142949164|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.04
71717214|NCT00539240|142949164|SUPERIORITY_OR_OTHER|||||||0.5||||||P\<0.05 considered statistically significant, no adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.50
71768080|NCT02880956|143037273|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828967|NCT04707313|143162522|SUPERIORITY||Odds Ratio (OR)|16.33|||||TWO_SIDED|90.0|6.47|41.24||||||Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.||41.24|6.47|
71717215|NCT00539240|142949165|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity||||||0.04
71717216|NCT00539240|142949165|SUPERIORITY_OR_OTHER|||||||0.2||||||P\<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity.||||||0.20
71717217|NCT02765399|142949168|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71717218|NCT02765399|142949168|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71717219|NCT02765399|142949169|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71717220|NCT02765399|142949169|OTHER|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
71717221|NCT02765399|142949170|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71717222|NCT02765399|142949170|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71717223|NCT02765399|142949171|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71717224|NCT02765399|142949171|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
71717225|NCT02765399|142949172|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71717226|NCT02765399|142949172|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||||||0.865
71717227|NCT02765399|142949173|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
71717228|NCT02765399|142949173|OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
71717229|NCT02765399|142949174|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
71717230|NCT02765399|142949174|OTHER|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||||||0.753
71717231|NCT02765399|142949175|OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
71717232|NCT02765399|142949175|OTHER|||||||0.499|||||||Wilcoxon (Mann-Whitney)|||||||0.499
71717233|NCT02765399|142949176|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71717234|NCT02765399|142949176|OTHER|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71717235|NCT02765399|142949177|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71717236|NCT02765399|142949177|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
71717237|NCT02765399|142949178|OTHER|||||||0.152|||||||Wilcoxon (Mann-Whitney)|||||||0.152
71717238|NCT02765399|142949178|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
71717239|NCT02765399|142949179|OTHER|||||||0.173|||||||Wilcoxon (Mann-Whitney)|||||||0.173
71717240|NCT02765399|142949179|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71717241|NCT02765399|142949180|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71717242|NCT02765399|142949180|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71717243|NCT02765399|142949181|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71717244|NCT02765399|142949181|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71717245|NCT02765399|142949182|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71717246|NCT02765399|142949182|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71717247|NCT02765399|142949183|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71717248|NCT02765399|142949183|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71717249|NCT02765399|142949184|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71717250|NCT02765399|142949184|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71717251|NCT02765399|142949185|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71717252|NCT02765399|142949185|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71717253|NCT02765399|142949186|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
71717254|NCT02765399|142949186|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71717255|NCT02765399|142949187|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||||||0.017
71717256|NCT02765399|142949187|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71717257|NCT02765399|142949188|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||||||0.068
71717258|NCT02765399|142949188|OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71717259|NCT00768261|142949190|OTHER|||||||0.095|TWO_SIDED|95.0|||||ANOVA|df= 3,92||||||0.095
71828968|NCT04707313|143162522|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|14.24|||||TWO_SIDED|90.0|5.39|37.66||||||||37.66|5.39|
71717260|NCT00768261|142949191|OTHER|||||||0.066|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.066
71717261|NCT00768261|142949191|OTHER|||||||0.009|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.009
71717262|NCT00768261|142949191|OTHER|||||||0.3|TWO_SIDED|95.0|||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."||||0.30
71717263|NCT00768261|142949191|OTHER|||||||0.0288|TWO_SIDED|95.0|||||Repeated Measures ANOVA|||RM-ANOVA on hippocampal volume slope||||0.0288
71717264|NCT02525679|142949202|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.5968|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|1.3784|1.8151|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.8151|1.3784|
71717265|NCT02525679|142949202|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0207|STANDARD_ERROR_OF_MEAN|0.0261|||TWO_SIDED|95.0|0.9668|1.0747|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for Cmax (log-transformed scale) was explored based on the linear regression model.||1.0747|0.9668|
71717266|NCT02525679|142949204|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.7123|STANDARD_ERROR_OF_MEAN|0.2525|||TWO_SIDED|95.0|2.1856|3.2389|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||3.2389|2.1856|
71828969|NCT04707313|143162522|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|30.17|||||TWO_SIDED|90.0|11.35|80.2||||||||80.20|11.35|
71717267|NCT02525679|142949204|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0003|STANDARD_ERROR_OF_MEAN|0.0253|||TWO_SIDED|95.0|0.9482|1.0525|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality in plasma for AUC(0-tz) (log-transformed scale) was explored based on the linear regression model.||1.0525|0.9482|
71717268|NCT03958331|142949265|SUPERIORITY||Mean Difference (Final Values)|10.62|STANDARD_ERROR_OF_MEAN|3.38||0.002|TWO_SIDED|95.0|4.0|17.25|||ANCOVA|Model controlled for baseline adherence, resistance to peer influence, dose, active seizures, COVID timing, COVID Impact (3 items), and sex|||We also conducted a longitudinal mixed effects model for adherence over time, estimating a groupXtime interaction with the same covariates listed above and allowing for a non-linear effect.|17.25|4|0.002
71717269|NCT01911351|142949275|SUPERIORITY_OR_OTHER||kappa statistic|0.88|||<|0.001|TWO_SIDED|||||A priori threshold for statistical significance: p\< or = 0.05|Chi-squared|||A kappa statistic was performed for 75% of the group to assess inter-rater agreement of the perception of the success of the procedure.||||<0.001
71717270|NCT04422431|142949276|OTHER|||||||0.1002|||||||t-test, 2 sided|||||||0.1002
71717271|NCT02317627|142949309|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
71717272|NCT02317627|142949309|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0035||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0035
71717273|NCT02317627|142949309|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0261||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0261
71717274|NCT02317627|142949309|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change for all subjects' PASI from baseline to Week 12.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
71717275|NCT02317627|142949310|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD PASI from baseline to Week 12.||||||0.0282||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0282
71717276|NCT02317627|142949310|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID PASI from baseline to Week 12.||||||0.0029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0029
71717277|NCT02317627|142949310|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID PASI from baseline to Week 12.||||||0.0703||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0703
71768081|NCT02880956|143037274|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.112||0.722|TWO_SIDED|95.0|-0.26|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.260|0.722
71768082|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.86|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768083|NCT02880956|143037274|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.878|TWO_SIDED|95.0|-0.232|0.198||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.198|-0.232|0.878
71768084|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768085|NCT02880956|143037274|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.112||0.535|TWO_SIDED|95.0|-0.151|0.29||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.290|-0.151|0.535
71768086|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|0.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768087|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.916|TWO_SIDED|95.0|-0.266|0.239||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.239|-0.266|0.916
71768088|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71828970|NCT04707313|143162522|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|9.88|||||TWO_SIDED|90.0|2.91|33.53||||||||33.53|2.91|
71828971|NCT04707313|143162522|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|24.41|||||TWO_SIDED|90.0|8.28|71.95||||||||71.95|8.28|
71828972|NCT04707313|143162522|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|12.65|||||TWO_SIDED|90.0|4.56|35.08||||||||35.08|4.56|
71828973|NCT04707313|143162523|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|33.43|||||TWO_SIDED|90.0|3.05|366.64||||||||366.64|3.05|
71768089|NCT02880956|143037274|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.126||0.511|TWO_SIDED|95.0|-0.33|0.165||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.165|-0.330|0.511
71768090|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768091|NCT02880956|143037274|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.129||0.771|TWO_SIDED|95.0|-0.217|0.292||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.292|-0.217|0.771
71768092|NCT02880956|143037274|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||Week 96||||
71768093|NCT02880956|143037275|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.086||0.903|TWO_SIDED|95.0|-0.159|0.18||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.180|-0.159|0.903
71768094|NCT02880956|143037275|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|0.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768095|NCT02880956|143037275|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.084||0.811|TWO_SIDED|95.0|-0.185|0.145||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.145|-0.185|0.811
71768096|NCT02880956|143037275|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|0.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768097|NCT02880956|143037275|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.086||0.775|TWO_SIDED|95.0|-0.145|0.194||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.194|-0.145|0.775
71768098|NCT02880956|143037275|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768099|NCT02880956|143037275|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.273|TWO_SIDED|95.0|-0.337|0.096||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.096|-0.337|0.273
71717278|NCT02317627|142949310|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects' PASI from baseline to Week 12.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
71717279|NCT02317627|142949315|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 4.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
71717280|NCT02317627|142949315|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 4.||||||0.0479||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0479
71717281|NCT02317627|142949315|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 4.||||||0.1513||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.1513
71717282|NCT02317627|142949315|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 4.||||||0.0002||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0002
71717283|NCT02317627|142949316|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to Week 8.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
71717284|NCT02317627|142949316|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to Week 8.||||||0.0017||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0017
71717285|NCT02317627|142949316|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to Week 8.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
71717286|NCT02317627|142949316|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to Week 8.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
71717287|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 4 weeks.||||||0.014||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0140
71717288|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 4 weeks.||||||0.062||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0620
71717289|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in 400 mg BID from baseline to 4 weeks.||||||0.262||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.2620
71717290|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 4 weeks.||||||0.0008||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0008
71717291|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 8 weeks.||||||0.0137||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0137
71717292|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 8 weeks.||||||0.0064||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0064
71717293|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 8 weeks.||||||0.0743||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.0743
71717294|NCT02317627|142949317|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change of all subjects from baseline to 8 weeks.|||||<|0.0001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.0001
71717295|NCT02317627|142949322|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg QD from baseline to 12 weeks.||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
71717296|NCT02317627|142949322|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 200 mg BID from baseline to 12 weeks.||||||0.007||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.007
71717297|NCT02317627|142949322|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change in Cohort 400 mg BID from baseline to 12 weeks.||||||0.09||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.090
71717298|NCT02317627|142949322|OTHER|No control group was used. Paired t-testing was used to determine the statistical significance of the mean change Overall from baseline to 12 weeks.|||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
71768100|NCT02880956|143037275|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768101|NCT02880956|143037275|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.108||0.74|TWO_SIDED|95.0|-0.248|0.176||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.176|-0.248|0.740
71768102|NCT02880956|143037275|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768103|NCT02880956|143037275|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.567|TWO_SIDED|95.0|-0.282|0.155||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.155|-0.282|0.567
71768104|NCT02880956|143037275|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|0.8|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768105|NCT02880956|143037276|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.099||0.931|TWO_SIDED|95.0|-0.204|0.187||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.187|-0.204|0.931
71768106|NCT02880956|143037276|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828974|NCT04707313|143162523|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|34.04|||||TWO_SIDED|90.0|3.1|373.85||||||||373.85|3.10|
71828975|NCT04707313|143162523|SUPERIORITY|Logistic regression models (included terms for treatment, strata \[females versus males\] and baseline body weight as a covariate) were applied to the imputed datasets from the multiple imputation method above and parameter estimates were combined using standard multiple imputation techniques.|Odds Ratio (OR)|127.21|||||TWO_SIDED|90.0|10.55|1533.46||||||||1533.46|10.55|
71828976|NCT03165175|143162534|SUPERIORITY|||||||0.72||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.72
71828977|NCT03165175|143162535|SUPERIORITY|||||||0.598||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.598
71828978|NCT03165175|143162536|SUPERIORITY|||||||0.954||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.954
71717299|NCT02317627|142949323|SUPERIORITY|||||||0.004||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.004
71768107|NCT02880956|143037276|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.097||0.187|TWO_SIDED|95.0|-0.32|0.063||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.063|-0.320|0.187
71768108|NCT02880956|143037276|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|0.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828979|NCT03165175|143162537|SUPERIORITY|||||||0.167||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.167
71828980|NCT03165175|143162538|SUPERIORITY|||||||0.022||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA|||||||.022
71717300|NCT02317627|142949323|SUPERIORITY|||||||0.029||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.029
71717301|NCT02317627|142949323|SUPERIORITY|||||||0.084||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||0.084
71717302|NCT02317627|142949323|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p ≤ 0.05. No adjustments for multiplicity were made. Missing data were not imputed.|t-test, 2 sided|||||||< 0.001
71717303|NCT01088906|142949339|SUPERIORITY||Odds Ratio (OR)|34.0||||0.05|TWO_SIDED||||||Regression, Logistic|||||||0.05
71717304|NCT03384875|142949354|SUPERIORITY||Risk Difference (RD)|0.0||||0.517|TWO_SIDED||||||Chi-squared|||||||0.517
71717305|NCT00896012|142949361|OTHER|||||||0.222||||||Significance was considered to be P \< .05|t-test, 2 sided|||Statistical analysis was performed by analysis of variance and Student t test for estimated glomerular filtration rate (eGFR) at 12 months. Chi-square analysis was used for demographics data.||||0.222
71717306|NCT02735421|142949363|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71717307|NCT00939107|142949372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||>|0.05||95.0|0.2|2.8|||t-test, 2 sided|||||2.8|0.2|>0.05
71717308|NCT03181971|142949383|SUPERIORITY||Odds Ratio (OR)|0.7||||0.68|TWO_SIDED|95.0|0.2|2.9|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.9|0.2|0.68
71717309|NCT03181971|142949383|SUPERIORITY||Odds Ratio (OR)|0.1||||0.017|TWO_SIDED|95.0|0.03|0.7|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months||0.7|0.03|0.017
71717310|NCT03181971|142949384|SUPERIORITY||Odds Ratio (OR)|0.4||||0.24|TWO_SIDED|95.0|0.07|2.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||2.0|0.07|.24
71717311|NCT03181971|142949384|SUPERIORITY||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.1|7.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||7.0|0.1|.98
71717312|NCT03181971|142949385|SUPERIORITY||Adjusted mean difference|0.2||||0.57|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||1.0|-0.6|0.57
71768109|NCT02880956|143037276|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.961|TWO_SIDED|95.0|-0.191|0.201||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.201|-0.191|0.961
71768110|NCT02880956|143037276|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.73|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768111|NCT02880956|143037276|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.124||0.894|TWO_SIDED|95.0|-0.26|0.227||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.227|-0.260|0.894
71768112|NCT02880956|143037276|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768113|NCT02880956|143037276|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.121||0.917|TWO_SIDED|95.0|-0.226|0.251||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.251|-0.226|0.917
71828981|NCT01215695|143162548|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71828982|NCT01215695|143162549|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71828983|NCT01215695|143162550|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71828984|NCT01215695|143162551|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71828985|NCT01215695|143162552|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71828986|NCT01378065|143162575|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71828987|NCT01378065|143162576|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71828988|NCT01378065|143162577|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71828989|NCT01378065|143162578|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71828990|NCT01378065|143162579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||t-test, 2 sided|||||||0.202
71768114|NCT02880956|143037276|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768115|NCT02880956|143037276|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.124||0.639|TWO_SIDED|95.0|-0.186|0.303||The statistical model: ADCS-CGIC-MCI change from baseline = treatment + site + visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.303|-0.186|0.639
71768116|NCT02880956|143037276|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|0.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (placebo - 8E12) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768117|NCT02880956|143037277|SUPERIORITY||LS Mean of Difference|-1.57|STANDARD_ERROR_OF_MEAN|2.175||0.47|TWO_SIDED|95.0|-5.851|2.703||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.703|-5.851|0.470
71768118|NCT02880956|143037277|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|15.44|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768119|NCT02880956|143037277|SUPERIORITY||LS Mean of Difference|0.36|STANDARD_ERROR_OF_MEAN|2.127||0.864|TWO_SIDED|95.0|-3.819|4.548||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||4.548|-3.819|0.864
71768120|NCT02880956|143037277|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|15.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71828991|NCT01378065|143162580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71828992|NCT01378065|143162581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
71828993|NCT01378065|143162582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|TWO_SIDED||||||t-test, 2 sided|||||||0.034
71828994|NCT01378065|143162583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 weeks.||||0.001
71828995|NCT01378065|143162584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 3 months.||||0.004
71828996|NCT01378065|143162585|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 6 months.||||<.001
71828997|NCT01378065|143162586|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Analysis baseline to 12 months.||||<.001
71828998|NCT01713946|143162679|SUPERIORITY||Odds Ratio (OR)|2.21||||0.008|TWO_SIDED|95.0|1.16|4.2|||Bonferroni-Holm|||||4.20|1.16|0.008
71828999|NCT01713946|143162679|SUPERIORITY||Odds Ratio (OR)|3.93|||<|0.001|TWO_SIDED|95.0|2.1|7.32|||Bonferroni-Holm|||||7.32|2.10|<0.001
71829000|NCT01713946|143162680|SUPERIORITY||Median Difference (Final Values)|15.96||||0.003|TWO_SIDED|95.0|1.98|31.68|||Bonferroni-Holm|||||31.68|1.98|0.003
71829001|NCT01713946|143162680|SUPERIORITY||Odds Ratio (OR)|27.46|||<|0.001|TWO_SIDED|95.0|16.36|43.36|||Bonferroni-Holm|||||43.36|16.36|<0.001
71829002|NCT01713946|143162681|SUPERIORITY||Odds Ratio (OR)|6.55|||||TWO_SIDED|95.0|0.77|55.73||||||||55.73|0.77|
71829003|NCT01713946|143162681|SUPERIORITY||Odds Ratio (OR)|4.99|||||TWO_SIDED|95.0|0.57|44.03||||||||44.03|0.57|
71829004|NCT01713946|143162682|SUPERIORITY||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|1.05|2.97||||||||2.97|1.05|
71829005|NCT01713946|143162682|SUPERIORITY||Odds Ratio (OR)|3.82|||||TWO_SIDED|95.0|2.25|6.48||||||||6.48|2.25|
71829006|NCT01713946|143162684|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1||||||||3.1|-0.4|
71829007|NCT01713946|143162684|SUPERIORITY||Mean Difference (Final Values)|4.2|||||TWO_SIDED|95.0|2.5|5.9||||||||5.9|2.5|
71768121|NCT02880956|143037277|SUPERIORITY||LS Mean of Difference|-4.49|STANDARD_ERROR_OF_MEAN|2.206||0.043|TWO_SIDED|95.0|-8.826|-0.15||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||-0.150|-8.826|0.043
71768122|NCT02880956|143037277|SUPERIORITY||Effect size/pooled SD|-0.28|STANDARD_DEVIATION|16.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768123|NCT02880956|143037277|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|2.874||0.831|TWO_SIDED|95.0|-5.041|6.27||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||6.270|-5.041|0.831
71768124|NCT02880956|143037277|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|18.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768125|NCT02880956|143037277|SUPERIORITY||LS Mean of Difference|1.81|STANDARD_ERROR_OF_MEAN|2.843||0.525|TWO_SIDED|95.0|-3.784|7.404||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||7.404|-3.784|0.525
71768126|NCT02880956|143037277|OTHER||Effect size/pooled SD|0.1|STANDARD_ERROR_OF_MEAN|18.47|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829008|NCT01713946|143162685|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.77|2.07||||||||2.07|0.77|
71829009|NCT01713946|143162685|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.74|1.96||||||||1.96|0.74|
71829010|NCT01713946|143162686|SUPERIORITY||Difference in least square means|-1.1|||||TWO_SIDED|95.0|-4.4|2.1||||||||2.1|-4.4|
71829011|NCT01713946|143162686|SUPERIORITY||Difference in least square means|1.0|||||TWO_SIDED|95.0|-2.2|4.3||||||||4.3|-2.2|
71829012|NCT01713946|143162687|SUPERIORITY||Difference in least square means|-2.1|||||TWO_SIDED|95.0|-10.5|6.2||||||||6.2|-10.5|
71829013|NCT01713946|143162687|SUPERIORITY||Difference in least square means|0.4|||||TWO_SIDED|95.0|-7.8|8.6||||||||8.6|-7.8|
71829014|NCT01713946|143162688|SUPERIORITY||Difference in least square means|-2.8|||||TWO_SIDED|95.0|-17.9|12.3||||||||12.3|-17.9|
71768127|NCT02880956|143037277|SUPERIORITY||LS Mean of Difference|-1.49|STANDARD_ERROR_OF_MEAN|2.921||0.61|TWO_SIDED|95.0|-7.239|4.255||The statistical model: UPSA-Brief change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||4.255|-7.239|0.610
71768128|NCT02880956|143037277|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|19.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768129|NCT02880956|143037278|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|1.02||0.438|TWO_SIDED|95.0|-2.798|1.214||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||1.214|-2.798|0.438
71768130|NCT02880956|143037278|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|7.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768131|NCT02880956|143037278|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|1.005||0.419|TWO_SIDED|95.0|-1.164|2.788||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.788|-1.164|0.419
71768132|NCT02880956|143037278|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|7.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768133|NCT02880956|143037278|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|1.03||0.948|TWO_SIDED|95.0|-1.959|2.092||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 48||2.092|-1.959|0.948
71768134|NCT02880956|143037278|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|8.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768135|NCT02880956|143037278|SUPERIORITY||LS Mean of Difference|-1.04|STANDARD_ERROR_OF_MEAN|1.597||0.516|TWO_SIDED|95.0|-4.18|2.101||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||2.101|-4.180|0.516
71829015|NCT01713946|143162688|SUPERIORITY||Difference in least square means|-7.7|||||TWO_SIDED|95.0|-22.0|6.6||||||||6.6|-22.0|
71829016|NCT02296424|143162715|EQUIVALENCE|nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.||||||0.0001|||||||exact binomial test|||||||0.0001
71829017|NCT00807144|143162720|SUPERIORITY|||||||0.26|||||||Log Rank|||||||0.26
71829018|NCT00807144|143162721|SUPERIORITY|||||||0.48|||||||Log Rank|||Year 1||||0.48
71829019|NCT00807144|143162721|SUPERIORITY|||||||0.75|||||||Log Rank|||Year 2||||0.75
71829020|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.82|||||TWO_SIDED|95.0|1.27|2.61|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.61|1.27|
71717313|NCT03181971|142949385|SUPERIORITY||Adjusted mean difference|-0.5||||0.4|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.6|-1.5|.40
71717314|NCT03181971|142949386|SUPERIORITY||Adjusted mean difference|0.04||||0.46|TWO_SIDED|95.0|-0.06|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.1|-0.06|.46
71717315|NCT03181971|142949386|SUPERIORITY||Adjusted mean difference|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.1|-0.2|.80
71717316|NCT03181971|142949387|SUPERIORITY||Adjusted mean difference|0.001||||0.93|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||0.03|-0.03|.93
71717317|NCT03181971|142949387|SUPERIORITY||Adjusted mean difference|-0.02||||0.36|TWO_SIDED|95.0|-0.06|0.02|||Mixed Models Analysis|||Analysis of between group change from baseline to 15 months.||0.02|-0.06|.36
71717318|NCT03181971|142949388|SUPERIORITY||Percent difference in change|1.4||||0.7|TWO_SIDED|95.0|-5.3|8.5||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in total kcal intake from baseline to 7 months.||8.5|-5.3|0.70
71717319|NCT03181971|142949388|SUPERIORITY||Percent difference in change|3.7||||0.35|TWO_SIDED|95.0|-3.9|12.0||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change in intake of food kcal from baseline to 7 months.||12.0|-3.9|.35
71717320|NCT03181971|142949388|SUPERIORITY||Percent difference in change|-10.6||||0.35|TWO_SIDED|95.0|-29.2|8.8|||Mixed Models Analysis|||Analysis of between group change in intake of beverage kcal from baseline to 7 months.||8.8|-29.2|.35
71717321|NCT03181971|142949388|SUPERIORITY||Percent difference in change|-17.5||||0.18|TWO_SIDED|95.0|-37.8|9.6|||Mixed Models Analysis|||Analysis of between group change in SSB kcal from baseline to 7 months.||9.6|-37.8|.18
71717322|NCT03181971|142949389|SUPERIORITY||Percent difference in change|9.1||||0.59|TWO_SIDED|95.0|-20.6|49.9||Because of skewed distributions, dietary outcomes were log-transformed and regression coefficients were exponentiated to derive the percent change in outcomes by intervention status over time.|Mixed Models Analysis|||Analysis of between group change from baseline to 7 months.||49.9|-20.6|.59
71717323|NCT03181971|142949390|SUPERIORITY||Percent difference in change|23.2|||<|0.001|TWO_SIDED|95.0|13.1|34.2|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 7 months.||34.2|13.1|<.001
71717324|NCT03181971|142949390|SUPERIORITY||Percent difference in change|14.7||||0.004|TWO_SIDED|95.0|4.5|25.9|||Mixed Models Analysis|||Analysis of between group change in water intake from baseline to 15 months.||25.9|4.5|.004
71717325|NCT03181971|142949390|SUPERIORITY||Percent difference in change|-8.0||||0.063|TWO_SIDED|95.0|-15.7|0.4|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 7 months.||0.4|-15.7|0.063
71717326|NCT03181971|142949390|SUPERIORITY||Percent difference in change|-2.8||||0.56|TWO_SIDED|95.0|-11.7|6.9|||Mixed Models Analysis|||Analysis of between group change in SSB intake from baseline to 15 months.||6.9|-11.7|.56
71717327|NCT03181971|142949390|SUPERIORITY||Percent difference in change|1.2||||0.68|TWO_SIDED|95.0|-4.3|7.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 7 months.||7|-4.3|.68
71717328|NCT03181971|142949390|SUPERIORITY||Percent difference in change|-1.4||||0.66|TWO_SIDED|95.0|-7.4|5.0|||Mixed Models Analysis|||Analysis of between group change in juice intake from baseline to 15 months.||5|-7.4|.66
71717329|NCT03181971|142949390|SUPERIORITY||Percent difference in change|-4.0||||0.079|TWO_SIDED|95.0|-8.3|0.5|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 7 months.||0.5|-8.3|0.079
71717330|NCT03181971|142949390|SUPERIORITY||Percent difference in change|-3.0||||0.26|TWO_SIDED|95.0|-8.0|2.3|||Mixed Models Analysis|||Analysis of between group change in flavored milk intake from baseline to 15 months.||2.3|-8.0|.26
71717331|NCT03181971|142949390|SUPERIORITY||Percent difference in change|4.4||||0.2|TWO_SIDED|95.0|-2.2|11.5|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 7 months.||11.5|-2.2|.20
71717332|NCT03181971|142949390|SUPERIORITY||Percent difference in change|2.3||||0.51|TWO_SIDED|95.0|-4.4|9.6|||Mixed Models Analysis|||Analysis of between group change in plain milk intake from baseline to 15 months.||9.6|-4.4|.51
71717333|NCT03181971|142949391|SUPERIORITY||Percent difference in change|31.3|||<|0.001|TWO_SIDED|95.0|21.2|42.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at lunch from baseline to 7 months.||42.2|21.2|<.001
71717334|NCT03181971|142949391|SUPERIORITY||Percent difference in change|4.9||||0.22|TWO_SIDED|95.0|-3.0|13.5|||Mixed Models Analysis|||Analysis of between group change in water intake from water source during lunch from baseline to 15 months.||13.5|-3.0|.22
71717335|NCT03181971|142949391|SUPERIORITY||Percent difference in change|17.0||||0.02|TWO_SIDED|95.0|2.6|33.3|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 7 months.||33.3|2.6|.02
71717336|NCT03181971|142949391|SUPERIORITY||Percent difference in change|4.7||||0.48|TWO_SIDED|95.0|-8.0|19.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at recess from baseline to 15 months.||19.2|-8.0|.48
71717337|NCT03181971|142949391|SUPERIORITY||Percent difference in change|34.6||||0.14|TWO_SIDED|95.0|-9.4|99.8|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 7 months.||99.8|-9.4|.14
71717338|NCT03181971|142949391|SUPERIORITY||Percent difference in change|32.1||||0.16|TWO_SIDED|95.0|-11.0|96.2|||Mixed Models Analysis|||Analysis of between group change in water intake from water source at PE from baseline to 15 months.||96.2|-11.0|.16
71768136|NCT02880956|143037278|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768137|NCT02880956|143037278|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|1.582||0.971|TWO_SIDED|95.0|-3.055|3.168||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||3.168|-3.055|0.971
71768138|NCT02880956|143037278|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|11.24|||TWO_SIDED|||||||||Week 96||||
71768139|NCT02880956|143037278|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.621||0.392|TWO_SIDED|95.0|-4.577|1.8||The statistical model: ADCS-MCI-ADL-24 change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; var-covar structure = Unstructured.|repeated measures model|||Week 96||1.800|-4.577|0.392
71768140|NCT02880956|143037278|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|10.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768141|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.902||0.148|TWO_SIDED|95.0|-3.08|0.465||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.465|-3.080|0.148
71829021|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.57|||||TWO_SIDED|95.0|1.79|3.7|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.70|1.79|
71829022|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.7|||||TWO_SIDED|95.0|1.88|3.88|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||3.88|1.88|
71829023|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.79|||||TWO_SIDED|95.0|1.29|2.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.50|1.29|
71829024|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.19|||||TWO_SIDED|95.0|1.57|3.05|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.05|1.57|
71829025|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.52|||||TWO_SIDED|95.0|1.81|3.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||3.50|1.81|
71829026|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.68|||||TWO_SIDED|95.0|0.54|0.87|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.87|0.54|
71829027|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.12|0.69|
71829028|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.06|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||1.06|0.66|
71768142|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|6.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768143|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.896||0.092|TWO_SIDED|95.0|-3.278|0.246||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.246|-3.278|0.092
71768144|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|7.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768145|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.915||0.073|TWO_SIDED|95.0|-3.446|0.152||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.152|-3.446|0.073
71768146|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|6.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768147|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|0.47|STANDARD_ERROR_OF_MEAN|1.081||0.662|TWO_SIDED|95.0|-1.652|2.599||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.599|-1.652|0.662
71768148|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|8.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768149|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.057||0.992|TWO_SIDED|95.0|-2.089|2.068||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.068|-2.089|0.992
71829029|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.44|0.86|
71717339|NCT01772550|142949395|NON_INFERIORITY_OR_EQUIVALENCE|A 95% upper confidence bound for the observed difference in percentages of images with acceptable quality between the control catheter and evaluation catheter was calculated using the Score method. The 20 G BD Nexiva™ Diffusics™ can be considered non-inferior for acceptable image quality if this 95% upper confidence bound is smaller than 15% (i.e. C - D \< 15% with 95% confidence). The non-inferiority margin was 15%.|Risk Difference (RD)|0.0|||||ONE_SIDED|95.0||2.6|||||The difference in percent of acceptable image quality is used as an estimate. The Score method was used to estimate the upper 95% confidence limit.|Only the percent of acceptable image quality from the randomized test and reference catheter groups were considered for this statistical analysis. If C is the percentage of acceptable quality images with the control catheter, and D is the percentage of images of acceptable quality with the evaluation catheter, and the non-inferiority criteria is 15%, the hypotheses to be tested are as follows: H0: C - D \> or = 15%; H1: C - D \< 15%.||2.6||
71717340|NCT01127633|142949435|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.|Median Difference (Net)|-0.02||||0.974|TWO_SIDED|95.0|-1.14|1.11|||Mixed Models Analysis|||||1.11|-1.14|0.974
71717341|NCT00688467|142949450|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|26.0|STANDARD_DEVIATION|27.377||0.411|||||||ANOVA|||||||0.411
71717342|NCT00688467|142949451|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|23.3|STANDARD_DEVIATION|0.306||0.292|||||||ANOVA|||||||0.292
71717343|NCT00688467|142949453|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|-1.7|STANDARD_DEVIATION|16.261||0.927|||||||ANOVA|||||||0.927
71717344|NCT00688467|142949454|SUPERIORITY_OR_OTHER||100 * (placebo - navarixin) / placebo|4.3|STANDARD_DEVIATION|7.398||0.645|||||||ANOVA|||||||0.645
71717345|NCT02163577|142949463|SUPERIORITY||||||<|0.0001||||||Per generalized estimating equations (GEE) model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717346|NCT02163577|142949463|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717347|NCT02163577|142949463|SUPERIORITY||Difference in LS Means|-0.33|||||TWO_SIDED|95.0|-0.63|-0.04||||||Difference in change to Week 40||-0.04|-0.63|
71829030|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.54|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.54|0.93|
71829031|NCT04956575|143162777|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.55|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.55|0.93|
71717348|NCT02163577|142949463|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717349|NCT02163577|142949463|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717350|NCT02163577|142949463|SUPERIORITY||Difference in LS Means|-0.16|||||TWO_SIDED|95.0|-0.45|0.13||||||Difference in change to Week 64||0.13|-0.45|
71717351|NCT02163577|142949463|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717352|NCT02163577|142949463|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717353|NCT02163577|142949464|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71717354|NCT02163577|142949464|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71717355|NCT02163577|142949464|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71717356|NCT02163577|142949464|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71717357|NCT02163577|142949464|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71717358|NCT02163577|142949464|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71717359|NCT02163577|142949465|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71717360|NCT02163577|142949465|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71717361|NCT02163577|142949465|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71717362|NCT02163577|142949465|SUPERIORITY|||||||0.0024|||||||one sample t test|||Week 64||||0.0024
71717363|NCT02163577|142949465|SUPERIORITY|||||||0.0018|||||||one sample t test|||Week 160||||0.0018
71717364|NCT02163577|142949465|SUPERIORITY|||||||0.0002|||||||one sample t test|||Week 160||||0.0002
71717365|NCT02163577|142949466|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71717366|NCT02163577|142949466|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 40||||< 0.0001
71717367|NCT02163577|142949466|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71717368|NCT02163577|142949466|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71829032|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||1.44|0.57|
71829033|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.25|||||TWO_SIDED|95.0|0.78|2.0|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||2.00|0.78|
71829034|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.86|||||TWO_SIDED|95.0|1.16|2.99|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against H1N1 at Day 29.||2.99|1.16|
71829035|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.41|||||TWO_SIDED|95.0|0.91|2.21|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.21|0.91|
71829036|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|1.89|||||TWO_SIDED|95.0|1.21|2.97|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||2.97|1.21|
71829037|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|2.64|||||TWO_SIDED|95.0|1.68|4.14|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||4.14|1.68|
71829038|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.36|||||TWO_SIDED|95.0|0.26|0.5|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.50|0.26|
71829039|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.46|||||TWO_SIDED|95.0|0.33|0.64|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.64|0.33|
71717369|NCT02163577|142949466|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71717370|NCT02163577|142949466|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71717371|NCT02163577|142949467|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717372|NCT02163577|142949467|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717373|NCT02163577|142949467|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717374|NCT02163577|142949467|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717375|NCT02163577|142949467|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717376|NCT02163577|142949467|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717377|NCT02163577|142949468|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717378|NCT02163577|142949468|SUPERIORITY|||||||0.0015||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||0.0015
71717379|NCT02163577|142949468|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717380|NCT02163577|142949468|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717381|NCT02163577|142949468|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717382|NCT02163577|142949468|SUPERIORITY||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717383|NCT02163577|142949469|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717384|NCT02163577|142949469|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71829040|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.76|0.38|
71829041|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.62|||||TWO_SIDED|95.0|0.43|0.9|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||0.90|0.43|
71829042|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.92|||||TWO_SIDED|95.0|0.63|1.35|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.35|0.63|
71829043|NCT04956575|143162778|OTHER|The ratio of GMT was estimated by the ratio of model based GMT.|Ratio|0.75|||||TWO_SIDED|95.0|0.51|1.09|||||The 2 sided 95% assessed the difference in immune response between the mRNA-1010 compared with the active comparator, Afluria Quadrivalent, at Day 29.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||1.09|0.51|
71829044|NCT04956575|143162781|OTHER||Percent difference|12.61|||||TWO_SIDED|95.0|-2.0|27.93|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||27.93|-2.00|
71887222|NCT04871711|143294868|SUPERIORITY||Risk Difference (RD)|24.1|||<|0.001|TWO_SIDED|95.0|15.5|32.6||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.6|15.5|<0.001
71887223|NCT04871711|143294869|SUPERIORITY||Risk Difference (RD)|22.8|||<|0.001|TWO_SIDED|95.0|14.0|31.7||Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||31.7|14.0|<0.001
71717385|NCT02163577|142949469|SUPERIORITY||Difference in LS Means|0.21|||||TWO_SIDED|95.0|-0.12|0.54||||||Difference in change to Week 40||0.54|-0.12|
71717386|NCT02163577|142949469|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717387|NCT02163577|142949469|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717388|NCT02163577|142949469|SUPERIORITY||Difference in LS Means|-0.02|||||TWO_SIDED|95.0|-0.34|0.29||||||Difference in change to Week 64||0.29|-0.34|
71829045|NCT04956575|143162781|OTHER||Percent difference|25.17|||||TWO_SIDED|95.0|11.18|39.89|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||39.89|11.18|
71829046|NCT04956575|143162781|OTHER||Percent Difference|26.2|||||TWO_SIDED|95.0|12.33|40.84|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||40.84|12.33|
71829047|NCT04956575|143162781|OTHER||Percent Difference|25.59|||||TWO_SIDED|95.0|9.82|40.13|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.13|9.82|
71717389|NCT02163577|142949469|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717390|NCT02163577|142949469|SUPERIORITY||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717391|NCT02163577|142949470|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717392|NCT02163577|142949470|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717393|NCT02163577|142949470|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717394|NCT02163577|142949470|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717395|NCT02163577|142949470|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717396|NCT02163577|142949470|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717397|NCT02163577|142949471|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71829048|NCT04956575|143162781|OTHER||Percent Difference|31.35|||||TWO_SIDED|95.0|15.66|45.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||45.73|15.66|
71717398|NCT02163577|142949471|SUPERIORITY||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40||||< 0.0001
71717399|NCT02163577|142949471|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717400|NCT02163577|142949471|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717401|NCT02163577|142949471|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717402|NCT02163577|142949471|SUPERIORITY||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717403|NCT02163577|142949472|SUPERIORITY|||||||0.0088|||||||one sample t-test|||Week 0 to Week 40||||0.0088
71717404|NCT02163577|142949472|SUPERIORITY|||||||0.465|||||||one sample t-test|||Week 0 to Week 40||||0.4650
71717405|NCT02163577|142949472|SUPERIORITY|||||||0.016|||||||one sample t test|||Week 0 to Week 64||||0.0160
71717406|NCT02163577|142949472|SUPERIORITY|||||||0.4114|||||||one sample t test|||Week 0 to Week 64||||0.4114
71717407|NCT02163577|142949472|SUPERIORITY|||||||0.5335|||||||one sample t test|||Week 64 to Week 112||||0.5335
71717408|NCT02163577|142949472|SUPERIORITY|||||||0.8606|||||||one sample t test|||Week 64 to Week 112||||0.8606
71717409|NCT02163577|142949472|SUPERIORITY|||||||0.1627|||||||one sample t test|||Week 112 to Week 160||||0.1627
71717410|NCT02163577|142949472|SUPERIORITY|||||||0.4096|||||||one sample t test|||Week 112 to Week 160||||0.4096
71717411|NCT02163577|142949473|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717412|NCT02163577|142949473|SUPERIORITY|||||||0.0569||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40||||0.0569
71717413|NCT02163577|142949473|SUPERIORITY|||||||0.0002||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
71717414|NCT02163577|142949473|SUPERIORITY|||||||0.0456||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64||||0.0456
71717415|NCT02163577|142949473|SUPERIORITY||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717416|NCT02163577|142949473|SUPERIORITY|||||||0.0343||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160||||0.0343
71717417|NCT02163577|142949478|SUPERIORITY|||||||0.0771||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0771
71717418|NCT02163577|142949478|SUPERIORITY|||||||0.9098||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.9098
71717419|NCT02163577|142949478|SUPERIORITY|||||||0.0007||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0007
71717420|NCT02163577|142949478|SUPERIORITY|||||||0.0327||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0327
71717421|NCT02163577|142949478|SUPERIORITY|||||||0.1865||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.1865
71829049|NCT04956575|143162781|OTHER||Percent Difference|38.34|||||TWO_SIDED|95.0|22.98|52.3|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||52.30|22.98|
71829050|NCT04956575|143162781|OTHER||Percent Difference|-9.78|||||TWO_SIDED|95.0|-24.83|3.79|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||3.79|-24.83|
71717422|NCT02163577|142949478|SUPERIORITY|||||||0.2654||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2654
71717423|NCT02163577|142949479|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71768150|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|8.38|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829051|NCT04956575|143162781|OTHER||Percent Difference|0.64|||||TWO_SIDED|95.0|-14.91|14.73|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||14.73|-14.91|
71829052|NCT04956575|143162781|OTHER||Percent Difference|4.45|||||TWO_SIDED|95.0|-11.19|18.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||18.59|-11.19|
71829053|NCT04956575|143162781|OTHER||Percent Difference|8.97|||||TWO_SIDED|95.0|-6.72|23.09|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||23.09|-6.72|
71829054|NCT04956575|143162781|OTHER||Percent Difference|15.13|||||TWO_SIDED|95.0|-0.74|29.37|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||29.37|-0.74|
71829055|NCT04956575|143162781|OTHER||Percent Difference|19.08|||||TWO_SIDED|95.0|3.22|33.22|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent. against Yamagata-lineage at Day 29.||33.22|3.22|
71829056|NCT04956575|143162782|OTHER||Percent Difference|9.18|||||TWO_SIDED|95.0|-10.62|28.31|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||28.31|-10.62|
71829057|NCT04956575|143162782|OTHER||Percent Difference|18.09|||||TWO_SIDED|95.0|-1.81|36.61|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||36.61|-1.81|
71829058|NCT04956575|143162782|OTHER||Percent Difference|23.91|||||TWO_SIDED|95.0|4.2|41.86|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H1N1 at Day 29.||41.86|4.20|
71829059|NCT04956575|143162782|OTHER||Percent Difference|1.15|||||TWO_SIDED|95.0|-18.41|20.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||20.60|-18.41|
71829060|NCT04956575|143162782|OTHER||Percent Difference|22.21|||||TWO_SIDED|95.0|2.09|40.6|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||40.60|2.09|
71717424|NCT02163577|142949479|SUPERIORITY|||||||0.0144||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0144
71717425|NCT02163577|142949479|SUPERIORITY|||||||0.0384||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0384
71768151|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-0.82|STANDARD_ERROR_OF_MEAN|1.088||0.451|TWO_SIDED|95.0|-2.961|1.32||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.320|-2.961|0.451
71768152|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|7.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829061|NCT04956575|143162782|OTHER||Percent Difference|36.68|||||TWO_SIDED|95.0|17.38|53.36|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against H3N2 at Day 29.||53.36|17.38|
71829062|NCT04956575|143162782|OTHER||Percent Difference|-37.71|||||TWO_SIDED|95.0|-53.36|-20.45|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-20.45|-53.36|
71829063|NCT04956575|143162782|OTHER||Treatment Difference|-26.18|||||TWO_SIDED|95.0|-43.66|-6.9|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||-6.90|-43.66|
71829064|NCT04956575|143162782|OTHER||Percent Difference|-19.66|||||TWO_SIDED|95.0|-37.95|0.11|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Victoria-lineage at Day 29.||0.11|-37.95|
71829065|NCT04956575|143162782|OTHER||Percent Difference|-23.43|||||TWO_SIDED|95.0|-41.09|-4.26|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||-4.26|-41.09|
71768153|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.227||0.583|TWO_SIDED|95.0|-3.088|1.739||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.739|-3.088|0.583
71829066|NCT04956575|143162782|OTHER||Percent Difference|-4.44|||||TWO_SIDED|95.0|-24.09|15.59|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of against Afluria Quadrivalent Yamagata-lineage at Day 29.||15.59|-24.09|
71829067|NCT04956575|143162782|OTHER||Percent Difference|-8.79|||||TWO_SIDED|95.0|-28.13|11.27|||||Seroconversion percent difference of mRNA-1010 - Afluria Quadrivalent. 95% CI was calculated using the Miettinen-Nurminen (score) method.|Humoral immunogenicity of mRNA-1010 relative to that of Afluria Quadrivalent against Yamagata-lineage at Day 29.||11.27|-28.13|
71829068|NCT03593876|143162788|OTHER||||||||||||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess mean participant-therapist communication scores across intervention sessions. The mean and standard deviation of these scores was 3.00 (1.00). The a priori criterion for feasibility was a mean score of 2.0 or greater.|||
71829069|NCT03593876|143162789|OTHER||Mean Difference (Net)|51.71|STANDARD_DEVIATION|21.04|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change was Cohen's d(rm)=3.08.|||
71717426|NCT02163577|142949479|SUPERIORITY|||||||0.0004||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0004
71717427|NCT02163577|142949479|SUPERIORITY|||||||0.9795||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.9795
71717428|NCT02163577|142949479|SUPERIORITY|||||||0.2082||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.2082
71768154|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|8.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768155|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-1.59|STANDARD_ERROR_OF_MEAN|1.213||0.191|TWO_SIDED|95.0|-3.975|0.795||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.795|-3.975|0.191
71829070|NCT03593876|143162790|OTHER||Mean Difference (Net)|11.02|STANDARD_DEVIATION|7.24|||TWO_SIDED|||||||||The a priori analysis plan was to defer statistical or hypothesis testing due to the focus on feasibility, and rather to assess change scores and effect size of the change scores to compare with previously published clinical trials.|The repeated measures effect size of change, Cohen's d(rm)=1.70|||
71829071|NCT00432458|143162793|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)||||||0.02
71887224|NCT04871711|143294870|SUPERIORITY||Risk Difference (RD)|12.3||||0.001|TWO_SIDED|95.0|5.7|18.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||18.9|5.7|0.001
71717429|NCT02163577|142949480|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717430|NCT02163577|142949480|SUPERIORITY|||||||0.0251||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0251
71717431|NCT02163577|142949480|SUPERIORITY|||||||0.9124||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.9124
71768156|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|9.37|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768157|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.238||0.372|TWO_SIDED|95.0|-3.541|1.329|||repeated measures model|||Week 72||1.329|-3.541|0.372
71768158|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|8.96|||TWO_SIDED|||||||||Week 72||||
71768159|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|1.303||0.447|TWO_SIDED|95.0|-3.553|1.571||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.571|-3.553|0.447
71829072|NCT00432458|143162794|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||Chi-squared|||||||0.0048
71829073|NCT00432458|143162795|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71717432|NCT02163577|142949480|SUPERIORITY|||||||0.0016||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0016
71768160|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|9.35|||TWO_SIDED|||||||||Week 96||||
71717433|NCT02163577|142949480|SUPERIORITY|||||||0.5677||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.5677
71717434|NCT02163577|142949480|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717435|NCT02163577|142949481|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717436|NCT02163577|142949481|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717437|NCT02163577|142949481|SUPERIORITY|||||||0.0033||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0033
71717438|NCT02163577|142949481|SUPERIORITY|||||||0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0001
71717439|NCT02163577|142949481|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717440|NCT02163577|142949481|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717441|NCT02163577|142949482|SUPERIORITY|||||||0.0014||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0014
71717442|NCT02163577|142949482|SUPERIORITY|||||||0.0028||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0028
71717443|NCT02163577|142949482|SUPERIORITY|||||||0.0536||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0536
71717444|NCT02163577|142949482|SUPERIORITY|||||||0.0002||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0002
71717445|NCT02163577|142949482|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717446|NCT02163577|142949482|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717447|NCT02163577|142949483|SUPERIORITY|||||||0.223||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.2230
71717448|NCT02163577|142949483|SUPERIORITY|||||||0.1132||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.1132
71717449|NCT02163577|142949483|SUPERIORITY|||||||0.2558||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.2558
71717450|NCT02163577|142949483|SUPERIORITY|||||||0.0814||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0814
71717451|NCT02163577|142949483|SUPERIORITY|||||||0.0093||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||0.0093
71768161|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|1.285||0.881|TWO_SIDED|95.0|-2.334|2.719||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.719|-2.334|0.881
71768162|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|8.68|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768163|NCT02880956|143037279|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|1.338||0.853|TWO_SIDED|95.0|-2.881|2.383||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.383|-2.881|0.853
71768164|NCT02880956|143037279|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|8.54|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768165|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.846||0.287|TWO_SIDED|95.0|-2.567|0.762||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.762|-2.567|0.287
71717452|NCT02163577|142949483|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717453|NCT02163577|142949484|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||< 0.0001
71717454|NCT02163577|142949484|SUPERIORITY|||||||0.0006||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40||||0.0006
71717455|NCT02163577|142949484|SUPERIORITY|||||||0.026||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||0.0260
71717456|NCT02163577|142949484|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64||||< 0.0001
71717457|NCT02163577|142949484|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717458|NCT02163577|142949484|SUPERIORITY||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160||||< 0.0001
71717459|NCT02163577|142949488|SUPERIORITY|||||||0.0003|||||||one sample t test|||Week 40||||0.0003
71717460|NCT02163577|142949488|SUPERIORITY|||||||0.0021|||||||one sample t test|||Week 40||||0.0021
71717461|NCT02163577|142949488|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71717462|NCT02163577|142949488|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 64||||< 0.0001
71717463|NCT02163577|142949488|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71717464|NCT02163577|142949488|SUPERIORITY||||||<|0.0001|||||||one sample t test|||Week 160||||< 0.0001
71717465|NCT01343888|142949497|SUPERIORITY_OR_OTHER||Koch's method|27.5|||<|0.0001|TWO_SIDED|95.0|17.9|37.0||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.0|17.9|<0.0001
71768166|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|6.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71717466|NCT01343888|142949497|SUPERIORITY_OR_OTHER||Koch's methond|28.6|||<|0.0001|TWO_SIDED|95.0|19.0|38.2||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||38.2|19.0|<0.0001
71717467|NCT01343888|142949497|SUPERIORITY_OR_OTHER||Koch's method|-1.0|||||TWO_SIDED|95.0|-7.9|5.8|||||adjusted for genotype and race using Koch's method, with continuity correction|||5.8|-7.9|
71717468|NCT01343888|142949498|SUPERIORITY_OR_OTHER||Koch's method|27.1|||<|0.0001|TWO_SIDED|95.0|17.5|36.7||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||36.7|17.5|<0.0001
71717469|NCT01343888|142949498|SUPERIORITY_OR_OTHER||Koch's method|27.8|||<|0.0001|TWO_SIDED|95.0|18.2|37.4||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction|||37.4|18.2|<0.0001
71717470|NCT01343888|142949498|SUPERIORITY_OR_OTHER||Koch's method|-0.6|||||TWO_SIDED|95.0|-7.6|6.3|||||adjusted for genotype and race using Koch's method, with continuity correction|||6.3|-7.6|
71717471|NCT01847092|142949538|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||||||0.279
71717472|NCT01847092|142949539|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
71717473|NCT01331681|142949542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|97.5|6.5|12.0||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|Least square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||12.0|6.5|<0.0001
71717474|NCT01331681|142949542|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|97.5|6.3|11.8||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||11.8|6.3|<0.0001
71717475|NCT01331681|142949543|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|28.7|||<|0.0001|TWO_SIDED|97.5|15.8|41.6||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||41.6|15.8|<0.0001
71717476|NCT01331681|142949543|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|27.5|||<|0.0001|TWO_SIDED|97.5|14.6|40.5||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 10 letters identical in both groups||40.5|14.6|<0.0001
71717477|NCT01331681|142949544|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|23.3|||<|0.0001|TWO_SIDED|97.5|12.6|33.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||33.9|12.6|<0.0001
71717478|NCT01331681|142949544|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|24.2|||<|0.0001|TWO_SIDED|97.5|13.5|34.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain \>= 15 letters identical in both groups||34.9|13.5|<0.0001
71717479|NCT01331681|142949545|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|25.8|||<|0.0001|TWO_SIDED|97.5|12.2|39.4||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||39.4|12.2|<0.0001
71717480|NCT01331681|142949545|SUPERIORITY_OR_OTHER_LEGACY||CMH adjusted difference|19.3||||0.0006|TWO_SIDED|97.5|6.6|32.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by \>= 2 steps identical in both groups||32.1|6.6|0.0006
71717481|NCT01331681|142949546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-157.0|||<|0.0001|TWO_SIDED|97.5|-190.9|-123.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-123.1|-190.9|<0.0001
71768167|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.838||0.227|TWO_SIDED|95.0|-2.661|0.633||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.633|-2.661|0.227
71768168|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768169|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.859||0.241|TWO_SIDED|95.0|-2.698|0.681||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.681|-2.698|0.241
71829074|NCT01290224|143162802|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided McNemar's test of the primary endpoint with 10 patients will have 86% power at 5% Type I error rate to detect a 60% difference in the percentage of at least 50% reduction in the scrambler and sham procedure, based on the assumption that the proportion of discordant pairs is at 70%.||||||0.763||95.0|||||McNemar|||McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.||||0.7630
71829075|NCT00346333|143162822|SUPERIORITY_OR_OTHER|||||||0.66||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||"Primary Analysis:Proc mixed of the Statistical Analysis System (SAS) was used to compare annual rates of change by treatment group over 4 years.~Power Calculation:240 patients were estimated to be needed to provide sufficient power (i.e. alpha=0.05;beta=0.10)to observe a statistically significant difference between mean change in the 2 groups on the HFA 30-2 total point score over a 4-year interval."||||0.66
71717482|NCT01331681|142949546|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-142.8|||<|0.0001|TWO_SIDED|97.5|-179.3|-106.3||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A negative value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||-106.3|-179.3|<0.0001
71768170|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|6.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768171|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|0.81|STANDARD_ERROR_OF_MEAN|0.958||0.397|TWO_SIDED|95.0|-1.073|2.696||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.696|-1.073|0.397
71768172|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|7.45|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768173|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.936||0.671|TWO_SIDED|95.0|-2.239|1.443||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.443|-2.239|0.671
71717483|NCT01331681|142949547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.41||||0.2208|TWO_SIDED|97.5|-2.01|6.82||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||6.82|-2.01|0.2208
71717484|NCT01331681|142949547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21||||0.5537|TWO_SIDED|97.5|-5.79|3.37||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||3.37|-5.79|0.5537
71717485|NCT01331681|142949548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19||||0.5138|TWO_SIDED|97.5|-5.29|2.91|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||2.91|-5.29|0.5138
71717486|NCT01331681|142949548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37||||0.8498|TWO_SIDED|97.5|-4.79|4.05|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups||4.05|-4.79|0.8498
71717487|NCT00461708|142949565|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71717488|NCT00461708|142949566|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71717489|NCT02394561|142949567|NON_INFERIORITY|The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was \< 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.|difference|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||||6.2|-8.8|
71717490|NCT02394561|142949570|OTHER|difference between cohorts for PASI 90 using Kaplan-Meier estimate||||||0.1295|||||||Log Rank|||||||0.1295
71717491|NCT02394561|142949570|OTHER|||||||0.447||||||difference between cohorts for PASI 75 using Kaplan-Meier estimate|Log Rank|||||||0.4470
71717492|NCT02394561|142949571|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|At all time points||||||<.0001
71717493|NCT02394561|142949572|SUPERIORITY||||||<|0.0001||||||All time points|Wilcoxon (Mann-Whitney)|||||||<.0001
71717494|NCT04577781|142949581|SUPERIORITY||Least Squares (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.353||0.885|TWO_SIDED|90.0|-0.66|0.55||Mixed model repeated measure (MMRM) with treatment-by-visit interaction and baseline-by-visit interaction as fixed effects (with an unstructured variance-covariance matrix).|MMRM|||||0.55|-0.66|0.885
71717495|NCT01957865|142949584|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Linear and Poisson regressions|||In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.||||<0.05
71717496|NCT01957865|142949585|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher's exact test|||HIV RNA suppression (\<100 copies/ml) was compared among study arms by Fisher's exact test.||||<0.05
71717497|NCT01044030|142949589|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Chi-squared|||||||0.6
71717498|NCT00114127|142949654|SUPERIORITY_OR_OTHER||||||<|0.132||95.0|||||t-test, 2 sided|||||||<0.132
71717499|NCT00114127|142949655|SUPERIORITY_OR_OTHER||||||<|0.292||95.0|||||t-test, 2 sided|||||||<.292
71717500|NCT00881894|142949660|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9864||||||90.0|0.9103|1.0688|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0688|0.9103|
71717501|NCT00881894|142949661|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9584||||||90.0|0.8861|1.0367|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0367|0.8861|
71717502|NCT00881894|142949662|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9896||||||90.0|0.9179|1.0671|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).||Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0671|0.9179|
71717503|NCT04005586|142949676|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group had a mean MRCYL of -0.14 (+/- 0.21D) compared to -0.33 (+/- 0.29D) and -0.40 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066 respectively.|||
71717504|NCT04005586|142949677|OTHER|The comparison was made by descriptive statistics.||||||||||||||||Two different historical controls implanted under NCT01496066 were used.|The LAL treatment group MRCYL change from baseline was 0.36 (+/- 0.21D) compared to 0.17 (+/- 0.29D) and 0.10 (+/- 0.36D) for the LAL historical control group and the monofocal IOL historical control group in NCT01496066, respectively.|||
71887225|NCT04871711|143294871|SUPERIORITY||Risk Difference (RD)|10.4|||<|0.001|TWO_SIDED|95.0|5.3|15.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||15.6|5.3|<0.001
71887226|NCT04871711|143294872|SUPERIORITY||Risk Difference (RD)|21.0|||<|0.001|TWO_SIDED|95.0|12.6|29.4||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||29.4|12.6|<0.001
71717505|NCT04016714|142949703|OTHER||Difference in percentage vs Prevenar 13™|-5.5|||=|0.05|TWO_SIDED|95.0|-11.0|0.0|||Miettinen & Nurminen method|||Injection-site erythema||0.0|-11.0|= 0.050
71717506|NCT04016714|142949703|OTHER||Difference in percentage vs Prevenar 13™|-2.1|||=|0.46|TWO_SIDED|95.0|-7.7|3.5|||Miettinen & Nurminen method|||Injection-site induration||3.5|-7.7|= 0.460
71717507|NCT04016714|142949703|OTHER||Difference in percentage vs Prevenar 13™|3.4|||=|0.225|TWO_SIDED|95.0|-2.1|8.9|||Miettinen & Nurminen method|||Injection-site pain||8.9|-2.1|= 0.225
71717508|NCT04016714|142949703|OTHER||Difference in percentage vs Prevenar 13™|2.3|||=|0.43|TWO_SIDED|95.0|-3.4|7.9|||Miettinen & Nurminen method|||Injection-site swelling||7.9|-3.4|= 0.430
71717509|NCT04016714|142949704|OTHER||Difference in percentage vs Prevenar 13™|-3.5|||=|0.229|TWO_SIDED|95.0|-9.1|2.2|||Miettinen & Nurminen method|||Decreased appetite||2.2|-9.1|= 0.229
71717510|NCT04016714|142949704|OTHER||Difference in percentage vs Prevenar 13™|2.2|||=|0.077|TWO_SIDED|95.0|-0.2|4.7|||Miettinen & Nurminen method|||Irritability||4.7|-0.2|= 0.077
71717511|NCT04016714|142949704|OTHER||Difference in percentage vs Prevenar 13™|-0.6|||=|0.793|TWO_SIDED|95.0|-5.4|4.1|||Miettinen & Nurminen method|||Somnolence||4.1|-5.4|= 0.793
71717512|NCT04016714|142949704|OTHER||Difference in percentage vs Prevenar 13™|-4.6|||=|0.045|TWO_SIDED|95.0|-9.1|-0.1|||Miettinen & Nurminen method|||Urticaria||-0.1|-9.1|= 0.045
71717513|NCT04016714|142949705|OTHER||Difference in percentage vs Prevenar 13™|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Vaccine-related SAEs||0.9|-0.9|
71717514|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% confidence interval (CI) for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.3|-0.6|||Miettinen & Nurminen method|||Serotype 1||-0.6|-4.3|< 0.001
71717515|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|10.5|||<|0.001|TWO_SIDED|95.0|6.6|14.6|||Miettinen & Nurminen method|||Serotype 3||14.6|6.6|< 0.001
71717516|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-1.9|||<|0.001|TWO_SIDED|95.0|-4.0|0.0|||Miettinen & Nurminen method|||Serotype 4||0.0|-4.0|< 0.001
71717517|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.4|0.8|||Miettinen & Nurminen method|||Serotype 5||0.8|-1.4|< 0.001
71717518|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.5|1.0|||Miettinen & Nurminen method|||Serotype 6A||1.0|-1.5|< 0.001
71717519|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-1.2|1.5|||Miettinen & Nurminen method|||Serotype 6B||1.5|-1.2|< 0.001
71717520|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.4|1.4|||Miettinen & Nurminen method|||Serotype 7F||1.4|-0.4|< 0.001
71717521|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 9V||1.2|-0.8|< 0.001
71717522|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.7|0.7|||Miettinen & Nurminen method|||Serotype 14||0.7|-1.7|< 0.001
71717523|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.5|||Miettinen & Nurminen method|||Serotype 18C||1.5|-0.6|< 0.001
71717524|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.7|||Miettinen & Nurminen method|||Serotype 19A||0.7|-1.3|< 0.001
71717525|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Serotype 19F||1.2|-0.8|< 0.001
71717526|NCT04016714|142949706|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage point difference|0.9|||<|0.001|TWO_SIDED|95.0|-1.2|3.0|||Miettinen & Nurminen method|||Serotype 23F||3.0|-1.2|< 0.001
71717527|NCT04016714|142949706|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|94.0|||<|0.001|TWO_SIDED|95.0|91.6|95.8|||Miettinen & Nurminen method|||Serotype 22F||95.8|91.6|< 0.001
71717528|NCT04016714|142949706|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage point difference|97.2|||<|0.001|TWO_SIDED|95.0|95.4|98.4|||Miettinen & Nurminen method|||Serotype 33F||98.4|95.4|< 0.001
71717529|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.54|0.63|||t-test, 1 sided|||Serotype 1||0.63|0.54|< 0.001
71768174|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|7.59|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768175|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.964||0.231|TWO_SIDED|95.0|-3.052|0.738||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.738|-3.052|0.231
71768176|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|7.25|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71717530|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|1.31|||<|0.001|TWO_SIDED|95.0|1.2|1.43|||t-test, 1 sided|||Serotype 3||1.43|1.20|< 0.001
71717531|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided|||Serotype 4||0.78|0.63|< 0.001
71717532|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided|||Serotype 5||0.68|0.56|< 0.001
71717533|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.67|||t-test, 1 sided|||Serotype 6A||0.67|0.54|< 0.001
71717534|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||t-test, 1 sided|||Serotype 6B||1.00|0.79|< 0.001
71717535|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.81|||t-test, 1 sided|||Serotype 7F||0.81|0.69|< 0.001
71768177|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|2.47|STANDARD_ERROR_OF_MEAN|1.137||0.031|TWO_SIDED|95.0|0.23|4.701||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||4.701|0.230|0.031
71829076|NCT00346333|143162822|SUPERIORITY_OR_OTHER|||||||0.52||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.52
71829077|NCT00346333|143162823|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary Analysis: Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye. Each patient contributed 2, 1, or 0 eyes with non-missing data.||||0.05
71717536|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.64|0.76|||t-test, 1 sided|||Serotype 9V||0.76|0.64|< 0.001
71717537|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.87|||t-test, 1 sided|||Serotype 14||0.87|0.70|< 0.001
71717538|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.77|0.92|||t-test, 1 sided|||Serotype 18C||0.92|0.77|< 0.001
71717539|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.82|||t-test, 1 sided|||Serotype 19A||0.82|0.68|< 0.001
71717540|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.87|||t-test, 1 sided|||Serotype 19F||0.87|0.72|< 0.001
71717541|NCT04016714|142949707|NON_INFERIORITY|For the 13 shared serotypes, a conclusion of non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.81|1.0|||t-test, 1 sided|||Serotype 23F||1.00|0.81|< 0.001
71717542|NCT04016714|142949707|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2- sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|68.34|||<|0.001|TWO_SIDED|95.0|61.73|75.65|||t-test, 1 sided|||Serotype 22F||75.65|61.73|< 0.001
71717543|NCT04016714|142949707|SUPERIORITY|For the 2 serotypes unique to V114, a conclusion of superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC ratio|48.99|||<|0.001|TWO_SIDED|95.0|44.45|54.01|||t-test, 1 sided|||Serotype 33F||54.01|44.45|< 0.001
71717544|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Diphtheria toxoid||1.0|-0.6|< 0.001
71717545|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Tetanus toxoid||1.0|-0.6|< 0.001
71717546|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - PT||1.0|-0.6|< 0.001
71717547|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.0|||Miettinen & Nurminen method|||Pertussis - FHA||1.0|-0.6|< 0.001
71717548|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - FIM 2/3||1.2|-0.8|< 0.001
71717549|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.8|1.2|||Miettinen & Nurminen method|||Pertussis - PRN||1.2|-0.8|< 0.001
71717550|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-1.1|||<|0.001|TWO_SIDED|95.0|-3.3|0.9|||Miettinen & Nurminen method|||Hib-PRP||0.9|-3.3|< 0.001
71717551|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|-0.6|||<|0.001|TWO_SIDED|95.0|-2.0|0.5|||Miettinen & Nurminen method|||HBsAg||0.5|-2.0|< 0.001
71768178|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|0.29|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71717552|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen method|||Poliovirus 1||0.9|-0.9|< 0.001
71717553|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.6|1.1|||Miettinen & Nurminen method|||Poliovirus 2||1.1|-0.6|< 0.001
71717554|NCT04016714|142949708|NON_INFERIORITY|A conclusion of non-inferiority of Vaxelis™ administered concomitantly with V114 to Vaxelis™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the specified non-inferiority margin (1-sided p-value \<0.025).|Percentage point difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.8|0.7|||Miettinen & Nurminen method|||Poliovirus 3||0.7|-0.8|< 0.001
71768179|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|0.68|STANDARD_ERROR_OF_MEAN|1.124||0.547|TWO_SIDED|95.0|-1.532|2.888||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.888|-1.532|0.547
71768180|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|9.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768181|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|0.73|STANDARD_ERROR_OF_MEAN|1.145||0.524|TWO_SIDED|95.0|-1.521|2.984||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.984|-1.521|0.524
71768182|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|8.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768183|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.356||0.54|TWO_SIDED|95.0|-3.499|1.836||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.836|-3.499|0.540
71768184|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|10.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71717555|NCT04016714|142949710|OTHER||GMC ratio|0.82|||||TWO_SIDED|95.0|0.75|0.89||||||Serotype 1||0.89|0.75|
71717556|NCT04016714|142949710|OTHER||GMC ratio|1.81|||||TWO_SIDED|95.0|1.66|1.98||||||Serotype 3||1.98|1.66|
71717557|NCT04016714|142949710|OTHER||GMC ratio|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Serotype 4||1.21|0.99|
71717558|NCT04016714|142949710|OTHER||GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01||||||Serotype 5||1.01|0.81|
71717559|NCT04016714|142949710|OTHER||GMC ratio|0.44|||||TWO_SIDED|95.0|0.38|0.5||||||Serotype 6A||0.50|0.38|
71717560|NCT04016714|142949710|OTHER||GMC ratio|1.73|||||TWO_SIDED|95.0|1.46|2.05||||||Serotype 6B||2.05|1.46|
71717561|NCT04016714|142949710|OTHER||GMC ratio|0.78|||||TWO_SIDED|95.0|0.71|0.84||||||Serotype 7F||0.84|0.71|
71717562|NCT04016714|142949710|OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12||||||Serotype 9V||1.12|0.90|
71717563|NCT04016714|142949710|OTHER||GMC ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18||||||Serotype 14||1.18|0.89|
71717564|NCT04016714|142949710|OTHER||GMC ratio|0.75|||||TWO_SIDED|95.0|0.68|0.82||||||Serotype 18C||0.82|0.68|
71717565|NCT04016714|142949710|OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81||||||Serotype 19A||0.81|0.64|
71717566|NCT04016714|142949710|OTHER||GMC ratio|0.69|||||TWO_SIDED|95.0|0.62|0.77||||||Serotype 19F||0.77|0.62|
71717567|NCT04016714|142949710|OTHER||GMC ratio|1.32|||||TWO_SIDED|95.0|1.16|1.51||||||Serotype 23F||1.51|1.16|
71717568|NCT04016714|142949710|SUPERIORITY||GMC ratio|81.01|||||TWO_SIDED|95.0|73.12|89.75||||||Serotype 22F||89.75|73.12|
71717569|NCT04016714|142949710|OTHER||GMC ratio|7.81|||||TWO_SIDED|95.0|6.82|8.94||||||Serotype 33F||8.94|6.82|
71717570|NCT02358993|142949713|NON_INFERIORITY|Non-inferiority of the primary outcome was achieved if the lower limit of the 95% confidence interval of the mean difference was greater than the specified non-inferiority margin of 15%(a clinically relevant margin within the range of those commonly used in non-inferiority and equivalence trials for studies examining antibiotic use for UTI)|Risk Ratio (RR)|-0.01|||||TWO_SIDED|95.0||||||||||||
71717571|NCT01822665|142949731|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.63|-0.59||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.59|-1.63|<0.0001
71717572|NCT01822665|142949732|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.0095|TWO_SIDED|95.0|-1.23|-0.18|||t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||-0.18|-1.23|0.0095
71717573|NCT01822665|142949732|SUPERIORITY_OR_OTHER||LS mean difference|0.19||||0.4794|TWO_SIDED|95.0|-0.34|0.72||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.72|-0.34|0.4794
71717574|NCT01822665|142949732|SUPERIORITY_OR_OTHER||LS mean difference|0.4||||0.1429|TWO_SIDED|95.0|-0.14|0.95||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||0.95|-0.14|0.1429
71717575|NCT01822665|142949732|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.0001|TWO_SIDED|95.0|0.75|1.84||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.84|0.75|<0.0001
71717576|NCT01822665|142949732|SUPERIORITY_OR_OTHER||LS mean difference|0.89||||0.002|TWO_SIDED|95.0|0.34|1.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.||1.45|0.34|0.0020
71717577|NCT01822665|142949733|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.6497|TWO_SIDED|95.0|-0.49|0.31||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.31|-0.49|0.6497
71717578|NCT01822665|142949733|SUPERIORITY_OR_OTHER||LS mean difference|-0.06||||0.7591|TWO_SIDED|95.0|-0.46|0.34||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.34|-0.46|0.7591
71717579|NCT01822665|142949733|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4126|TWO_SIDED|95.0|-0.24|0.57||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.57|-0.24|0.4126
71717580|NCT01822665|142949733|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8903|TWO_SIDED|95.0|-0.39|0.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.45|-0.39|0.8903
71717581|NCT01822665|142949733|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.2227|TWO_SIDED|95.0|-0.16|0.67||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments||0.67|-0.16|0.2227
71717582|NCT01822665|142949733|SUPERIORITY_OR_OTHER||LS mean difference|0.23||||0.2855|TWO_SIDED|95.0|-0.2|0.65||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.||0.65|-0.20|0.2855
71829078|NCT00346333|143162823|SUPERIORITY_OR_OTHER|||||||0.03||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.03
71717583|NCT01822665|142949734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.19||||0.0084|TWO_SIDED|95.0|1.6|23.97||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||23.97|1.60|0.0084
71717584|NCT01822665|142949734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19||||0.0999|TWO_SIDED|95.0|0.8|12.74||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||12.74|0.80|0.0999
71717585|NCT01822665|142949734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.2845|TWO_SIDED|95.0|0.58|6.5|||Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.|||6.50|0.58|0.2845
71717586|NCT00959907|142949738|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||t-test, 2 sided|||||||0.832
71717587|NCT00959907|142949739|SUPERIORITY_OR_OTHER|||||||0.658||95.0|||||t-test, 2 sided|||||||0.658
71717588|NCT00959907|142949739|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||t-test, 2 sided|||||||0.739
71717589|NCT00959907|142949740|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||t-test, 2 sided|||||||0.184
71717590|NCT01722929|142949741|OTHER||||||<|0.0001||||||p-value is for the main effect for the Treatment, Time, and Treatment\*Time interaction.|Mixed Models Analysis|||A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.||||<0.0001
71717591|NCT01847443|142949756|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.107|||||TWO_SIDED|90.0|1.07|1.147|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.147|1.070|
71717592|NCT01847443|142949761|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.098|||||TWO_SIDED|90.0|1.061|1.137|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)||1.137|1.061|
71717593|NCT01847443|142949762|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.044|||||TWO_SIDED|90.0|1.002|1.089|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.089|1.002|
71717594|NCT01847443|142949763|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.071|||||TWO_SIDED|90.0|1.028|1.116|||ANOVA|||Null hypothesis stated that there was no difference between the test and reference gums in Cmax||1.116|1.028|
71717595|NCT03571971|142949764|SUPERIORITY|Based on published data, we conservatively estimated that the standard exercise (SE) group and load modification (LM) group would have a 20% and 50% treatment success rate, respectively. We defined treatment success as either: 1) at least 'moderately better' on the Global Rating of Change scale or 2) ≥2 point decrease on the Numeric Pain Rating Scale. With one-side type I error=0.1, power=80%, and allocation ratio is 1:1, we estimated the need for 22 participants in each group (total N=44).|Odds Ratio (OR)|1.09||||0.879|TWO_SIDED|95.0|0.36|3.35||The a priori threshold for statistical significance was set at 0.05.|Chi-squared|||||3.35|0.36|0.879
71717596|NCT03848455|142949776|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP2CA gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
71717597|NCT03848455|142949776|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of SYNJ1 gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
71717598|NCT03848455|142949776|OTHER|||||||0.149|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP3CB gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||0.149
71717599|NCT03848455|142949776|OTHER||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of NSF gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) - CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) - CT(ref, calibrator),ΔΔCT = ΔCT(test) - ΔCT(calibrator).||||<0.001
71717600|NCT04046939|142949779|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.2283|||<|0.0001|TWO_SIDED|95.0|0.121|0.431||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.2283 represents the ratio of the 150 mg BID week 12 ratio to baseline (0.2051), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.2283 is equivalent to a -77.17% change compared to placebo at week 12.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.431|0.121|<.0001
71717601|NCT04046939|142949779|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.3403||||0.0014|TWO_SIDED|95.0|0.177|0.653||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||0.3403 represents the ratio of the 75 mg BID week 12 ratio to baseline (0.3056), compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.3403 is equivalent to a -65.97% change compared to placebo at week 12.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.653|0.177|0.0014
71717602|NCT04046939|142949779|SUPERIORITY||Ratio to PBO of the ratios to baseline|0.4489||||0.019|TWO_SIDED|95.0|0.231|0.874||A closed hierarchical statistical testing was used. The previous endpoint in the hierarchy was not statistically significant. Therefore, this endpoint was not formally tested and is not considered statistically significant, despite a p-value \<0.05.|Mixed Models Analysis||0.4489 represents the ratio of the 37.5 mg BID week 12 ratio to baseline (0.4031) compared to the PBO week 12 ratio to baseline (0.8980). This ratio of 0.4489 is equivalent to a -55.11% change compared to placebo at week 12.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.874|0.231|0.0190
71768185|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.336||0.664|TWO_SIDED|95.0|-3.208|2.046||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.046|-3.208|0.664
71768186|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|10.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71717603|NCT04046939|142949780|SUPERIORITY||Mean Difference (Final Values)|0.0814||||0.4154|TWO_SIDED|95.0|-0.116|0.279||A closed hierarchical procedure testing dexpramipexole against placebo at Week 12 was used. (1) 150 mg BID for AEC (2) 75 mg BID for AEC (3) pooled 75 mg and 150 mg BID group for pre-bronchodilator FEV1; and (4) 37.5 mg BID for AEC.|Mixed Models Analysis||Estimate is the difference of the pooled 75 mg and 150 mg BID group from placebo in change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The combined 75 mg and 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.279|-0.116|0.4154
71717604|NCT04046939|142949780|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.1174|TWO_SIDED|95.0|-0.0456|0.4||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.400|-0.0456|0.1174
71717605|NCT04046939|142949780|SUPERIORITY||Mean Difference (Final Values)|-0.0143||||0.8998|TWO_SIDED|95.0|-0.24|0.211||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.211|-0.240|0.8998
71717606|NCT04046939|142949780|SUPERIORITY||Mean Difference (Final Values)|0.138||||0.2425|TWO_SIDED|95.0|-0.095|0.37||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in pre-bronchodilator FEV1 in liters from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement in lung function.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.370|-0.0950|0.2425
71717607|NCT04046939|142949781|SUPERIORITY||Mean Difference (Final Values)|-0.264||||0.3059|TWO_SIDED|95.0|-0.772|0.245||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.245|-0.772|0.3059
71717608|NCT04046939|142949781|SUPERIORITY||Mean Difference (Final Values)|-0.0457||||0.8642|TWO_SIDED|95.0|-0.575|0.484||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.484|-0.575|0.8642
71717609|NCT04046939|142949781|SUPERIORITY||Mean Difference (Final Values)|-0.0276||||0.9182|TWO_SIDED|95.0|-0.56|0.505||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID dexpramipexole group compared to the placebo group in change in ACQ-6 score from Baseline to Week 12 (end of primary treatment period). A negative value indicates improvement of asthma symptoms.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM).||0.505|-0.560|0.9182
71717610|NCT04046939|142949782|SUPERIORITY||Mean Difference (Final Values)|0.181||||0.0716|TWO_SIDED|95.0|-0.0163|0.378||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 150 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.378|-0.0163|0.0716
71717611|NCT04046939|142949782|SUPERIORITY||Mean Difference (Final Values)|0.00474||||0.9619|TWO_SIDED|95.0|-0.192|0.202||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 75 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.202|-0.192|0.9619
71768187|NCT02880956|143037280|SUPERIORITY||LS Mean of Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.39||0.393|TWO_SIDED|95.0|-3.923|1.546||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.546|-3.923|0.393
71768188|NCT02880956|143037280|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|9.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768189|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.262||0.946|TWO_SIDED|95.0|-0.534|0.498||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.498|-0.534|0.946
71768190|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71717612|NCT04046939|142949782|SUPERIORITY||Median Difference (Final Values)|0.0987||||0.3368|TWO_SIDED|95.0|-0.105|0.302||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference of the 37.5 mg BID Dexpramipexole group from placebo in change in post-bronchodilator FEV1 from Baseline to Week 12 (end of primary treatment period) in liters. A positive value indicates improvement in lung function.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.302|-0.105|0.3368
71717613|NCT04046939|142949783|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.4512|TWO_SIDED|95.0|-0.338|0.755||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 150 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 150 mg BID dexpramipexole group to placebo.||0.755|-0.338|0.4512
71717614|NCT04046939|142949783|SUPERIORITY||Mean Difference (Final Values)|-0.0642||||0.8214|TWO_SIDED|95.0|-0.627|0.499||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 75 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 75 mg BID dexpramipexole group to placebo.||0.499|-0.627|0.8214
71717615|NCT04046939|142949783|SUPERIORITY||Mean Difference (Final Values)|0.154||||0.5894|TWO_SIDED|95.0|-0.411|0.72||For secondary endpoints which were not key secondary endpoints, no adjustment for multiple testing was used and p \<0.05 was used for statistical significance.|ANCOVA||Estimate the difference in the 37.5 mg BID dexpramipexole group from the placebo group in the change in AQLQ score from Baseline to Week 12 (end of primary treatment period). A positive value indicates improvement of asthma symptoms.|An ANCOVA analysis was performed comparing the 37.5 mg BID dexpramipexole group to placebo.||0.720|-0.411|0.5894
71717616|NCT04046939|142949789|SUPERIORITY|||||||0.0196||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 150 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0196
71717617|NCT04046939|142949789|SUPERIORITY|||||||0.0207||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 75mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.0207
71768191|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.259||0.242|TWO_SIDED|95.0|-0.813|0.206||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.206|-0.813|0.242
71768192|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|2.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768193|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.266||0.541|TWO_SIDED|95.0|-0.685|0.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.360|-0.685|0.541
71768194|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768195|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.724|TWO_SIDED|95.0|-0.481|0.691||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.691|-0.481|0.724
71768196|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.36|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768197|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.29||0.236|TWO_SIDED|95.0|-0.226|0.913||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.913|-0.226|0.236
71768198|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|2.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768199|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.298||0.714|TWO_SIDED|95.0|-0.477|0.695||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.695|-0.477|0.714
71768200|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.11|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768201|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.277||0.86|TWO_SIDED|95.0|-0.496|0.593||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.593|-0.496|0.860
71717618|NCT04046939|142949789|SUPERIORITY|||||||0.5399||||||No adjustment for multiple testing of exploratory endpoints was used.|Wilcoxon (Mann-Whitney)|||The 37.5 mg BID dexpramipexole group was compared to placebo at Week 12 using a Wilcoxon rank sum test.||||0.5399
71717619|NCT04046939|142949790|SUPERIORITY||Mean Difference (Final Values)|-0.0233||||0.0084|TWO_SIDED|95.0|-0.0405|-0.00613||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00613|-0.0405|0.0084
71717620|NCT04046939|142949790|SUPERIORITY||Mean Difference (Final Values)|-0.0206||||0.0237|TWO_SIDED|95.0|-0.0384|-0.00281||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 75 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||-0.00281|-0.0384|0.0237
71717621|NCT04046939|142949790|SUPERIORITY||Mean Difference (Final Values)|-0.00215||||0.814|TWO_SIDED|95.0|-0.0203|0.016||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change absolute basophil count (automated differential) from Baseline to Week 12 (end of primary treatment period). A negative value represents fewer basophils.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||0.0160|-0.0203|0.8140
71717622|NCT04046939|142949791|SUPERIORITY||Mean Difference (Final Values)|-8.24||||0.1886|TWO_SIDED|95.0|-20.6|4.13||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 150 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 150 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||4.13|-20.6|0.1886
71717623|NCT04046939|142949791|SUPERIORITY||Mean Difference (Final Values)|-6.53||||0.3061|TWO_SIDED|95.0|-19.1|6.08||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 75 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 75mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||6.08|-19.1|0.3061
71717624|NCT04046939|142949791|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.1294|TWO_SIDED|95.0|-23.4|3.04||No adjustment for multiple testing of exploratory endpoints was used.|Mixed Models Analysis||Estimate is the difference of the 37.5 mg BID group from the placebo group in the change in FeNO from Baseline to Week 12 in liters. In eosinophilic asthma, a lower FeNO indicates less eosinophilic inflammation of the airway than a higher value.|The 37.5 mg BID dexpramipexole group was compared to placebo using a mixed effects model repeated-measures (MMRM) with terms for baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the post-baseline value minus the baseline value.||3.04|-23.4|0.1294
71717625|NCT00806260|142949796|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.07|||ONE_SIDED|90.0|0.21||||ANCOVA|||at alcohol level 0.10%|||0.21|
71717626|NCT00806260|142949796|NON_INFERIORITY_OR_EQUIVALENCE|step down test|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.05|||ONE_SIDED|90.0|0.12||||ANCOVA|||at alcohol level 0.07%|||0.12|
71717627|NCT00806260|142949796|NON_INFERIORITY_OR_EQUIVALENCE|step-down test|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|90.0|-0.03||||ANCOVA|||at alcohol level 0.04%|||-0.03|
71717628|NCT00806260|142949797|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.17|0.07|||ANCOVA|||at 2 hr timepoint||0.07|-0.17|
71717629|NCT00806260|142949797|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority test|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.18|0.04|||ANCOVA|||at 6 hr timepoint||0.04|-0.18|
71717630|NCT00806260|142949797|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||at 2 hr timepoint||0.06|-0.08|
71829079|NCT00346333|143162824|SUPERIORITY_OR_OTHER|||||||0.24||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary analysis:Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.||||0.24
71717631|NCT00806260|142949797|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.13|0.05|||ANCOVA|||at 6 hr timepoint||0.05|-0.13|
71717632|NCT01861665|142949812|SUPERIORITY|||||||0.8379||||||Pre Incision vs. Post Incision on Post op day 0.|t-test, 2 sided|||||||0.8379
71717633|NCT01861665|142949812|SUPERIORITY|||||||0.7263||||||Pre incision vs. Post incision post op day 1.|t-test, 2 sided|||||||0.7263
71717634|NCT01861665|142949812|SUPERIORITY|||||||0.5||||||Pre incision vs. Post incision day 2.|t-test, 2 sided|||||||0.5
71717635|NCT03247829|142949813|OTHER|||||||0.001|||||||t-test, 2 sided|Comparative p-values were calculated by two-sided t-tests (paired analysis).||||||0.001
71717636|NCT03247829|142949814|OTHER|||||||0.0931|||||||t-test, 2 sided|||||||0.0931
71717637|NCT01783444|142949822|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.74|||||TWO_SIDED|90.0|0.57|0.97||||||||0.97|0.57|
71717638|NCT01783444|142949823|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.96|1.66||||||||1.66|0.96|
71717639|NCT01783444|142949824|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.27|||||TWO_SIDED|90.0|0.95|1.7||||||||1.70|0.95|
71717640|NCT01783444|142949824|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.99|1.79||||||||1.79|0.99|
71717641|NCT01783444|142949827|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.09|||||TWO_SIDED|90.0|0.72|1.66||||||||1.66|0.72|
71717642|NCT01783444|142949827|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.18|||||TWO_SIDED|90.0|0.78|1.77||||||||1.77|0.78|
71717643|NCT01783444|142949828|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|0.64|||||TWO_SIDED|90.0|0.46|0.88||||||||0.88|0.46|
71717644|NCT01783444|142949828|NON_INFERIORITY|Hazard ratio obtained from stratified Cox model (stratified by presence/absence of visceral metastasis as per IWRS)|Hazard Ratio (HR)|1.33|||||TWO_SIDED|90.0|0.93|1.91||||||||1.91|0.93|
71717645|NCT01783444|142949829|OTHER||Mean Difference (Net)|4.3|||||TWO_SIDED|90.0|-3.3|11.9||||||Side-effects||11.9|-3.3|
71887227|NCT04871711|143294873|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
71717646|NCT01783444|142949829|OTHER||Mean Difference (Net)|-2.2|||||TWO_SIDED|90.0|-9.9|5.5||||||Side-effects||5.5|-9.9|
71717647|NCT01783444|142949829|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-10.4|3.8||||||Effectiveness||3.8|-10.4|
71717648|NCT01783444|142949829|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-9.7|3.0||||||Effectiveness||3.0|-9.7|
71717649|NCT01783444|142949829|OTHER||Mean Difference (Net)|-1.6|||||TWO_SIDED|90.0|-5.8|2.5||||||Convenience||2.5|-5.8|
71717650|NCT01783444|142949829|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|90.0|-5.5|3.3||||||Convenience||3.3|-5.5|
71717651|NCT01783444|142949829|OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|90.0|-8.3|2.9||||||Global Satisfaction||2.9|-8.3|
71717652|NCT01783444|142949829|OTHER||Mean Difference (Net)|-3.3|||||TWO_SIDED|90.0|-8.4|1.9||||||Global Satisfaction||1.9|-8.4|
71717653|NCT02722408|142949831|OTHER|||||||0.0041||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0041
71717654|NCT02722408|142949832|OTHER|||||||0.001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0010
71717655|NCT02722408|142949833|OTHER|||||||0.0012||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||||||0.0012
71717656|NCT02722408|142949834|OTHER|||||||0.056||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0560
71717657|NCT02722408|142949834|OTHER|||||||0.0219||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0219
71717658|NCT02722408|142949834|OTHER|||||||0.0286||||||Mixed-effects model for repeated measures analysis with Change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0286
71717659|NCT02722408|142949835|OTHER|||||||0.0058||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0058
71717660|NCT02722408|142949835|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0019
71717661|NCT02722408|142949835|OTHER|||||||0.0024||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0024
71717662|NCT02722408|142949836|OTHER|||||||0.0592||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0592
71717663|NCT02722408|142949836|OTHER|||||||0.0266||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0266
71717664|NCT02722408|142949836|OTHER|||||||0.0336||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0336
71717665|NCT02722408|142949837|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
71768202|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|2.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768203|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.274||0.476|TWO_SIDED|95.0|-0.733|0.343||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.343|-0.733|0.476
71768204|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71887228|NCT04871711|143294874|SUPERIORITY||Risk Difference (RD)|9.3||||0.004|TWO_SIDED|95.0|3.8|14.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||14.7|3.8|0.004
71717666|NCT02722408|142949837|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0017
71717667|NCT02722408|142949837|OTHER|||||||0.0017||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0017
71768205|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.276||0.586|TWO_SIDED|95.0|-0.393|0.694||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.694|-0.393|0.586
71768206|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|1.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768207|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.324||0.412|TWO_SIDED|95.0|-0.371|0.903||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.903|-0.371|0.412
71768208|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768209|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.319||0.45|TWO_SIDED|95.0|-0.386|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.868|-0.386|0.450
71768210|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768211|NCT02880956|143037281|SUPERIORITY||LS Mean of Difference|0.17|STANDARD_ERROR_OF_MEAN|0.33||0.612|TWO_SIDED|95.0|-0.481|0.816||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.816|-0.481|0.612
71768212|NCT02880956|143037281|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768213|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.405||0.52|TWO_SIDED|95.0|-1.058|0.535||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.535|-1.058|0.520
71768214|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.52|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768215|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.401||0.303|TWO_SIDED|95.0|-1.201|0.374||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.374|-1.201|0.303
71768216|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768217|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.412||0.23|TWO_SIDED|95.0|-1.307|0.315||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.315|-1.307|0.230
71717668|NCT02722408|142949838|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
71717669|NCT02722408|142949838|OTHER|||||||0.0255||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0255
71717670|NCT02722408|142949838|OTHER|||||||0.0312||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 86||||0.0312
71717671|NCT02722408|142949839|OTHER|||||||0.4489||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4489
71717672|NCT02722408|142949839|OTHER|||||||0.5964||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.5964
71717673|NCT02722408|142949839|OTHER|||||||0.6785||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6785
71717674|NCT02722408|142949840|OTHER|||||||0.2177||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2177
71717675|NCT02722408|142949840|OTHER|||||||0.3209||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3209
71768218|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.53|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71717676|NCT02722408|142949840|OTHER|||||||0.3101||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3101
71717677|NCT02722408|142949841|OTHER|||||||0.0057||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0057
71717678|NCT02722408|142949841|OTHER|||||||0.0022||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0022
71717679|NCT02722408|142949841|OTHER|||||||0.0029||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0029
71717680|NCT02722408|142949842|OTHER|||||||0.0008||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0008
71717681|NCT02722408|142949842|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.0005
71717682|NCT02722408|142949842|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.0002
71717683|NCT02722408|142949843|OTHER|||||||0.4103||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4103
71717684|NCT02722408|142949843|OTHER|||||||0.6164||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6164
71717685|NCT02722408|142949843|OTHER|||||||0.6732||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.6732
71717686|NCT02722408|142949844|OTHER|||||||0.2003||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.2003
71717687|NCT02722408|142949844|OTHER|||||||0.3323||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600mg: Day 56||||0.3323
71717688|NCT02722408|142949844|OTHER|||||||0.3047||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900mg: Day 84||||0.3047
71768219|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.5222||0.2|TWO_SIDED|95.0|-1.698|0.356||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.356|-1.698|0.200
71768220|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.07|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768221|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.508||0.873|TWO_SIDED|95.0|-1.08|0.917||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.917|-1.080|0.873
71768222|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71717689|NCT02722408|142949845|OTHER|||||||0.3601||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3601
71717690|NCT02722408|142949845|OTHER|||||||0.192||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1920
71717691|NCT02722408|142949845|OTHER|||||||0.2912||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2912
71717692|NCT02722408|142949845|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||<0.0001
71717693|NCT02722408|142949845|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||<0.0001
71829080|NCT00346333|143162824|SUPERIORITY_OR_OTHER|||||||0.2||||||Apriori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.||||0.20
71829081|NCT00346333|143162825|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over four years between the treatment groups.||||0.59
71717694|NCT02722408|142949845|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
71717695|NCT02722408|142949845|OTHER|||||||0.0444||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0444
71717696|NCT02722408|142949845|OTHER|||||||0.0159||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0159
71717697|NCT02722408|142949845|OTHER|||||||0.0235||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0235
71717698|NCT02722408|142949845|OTHER|||||||0.0005||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0005
71768223|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.524||0.388|TWO_SIDED|95.0|-1.482|0.576||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.576|-1.482|0.388
71768224|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768225|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.587||0.734|TWO_SIDED|95.0|-1.355|0.955||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.955|-1.355|0.734
71768226|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.91|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768227|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.579||0.417|TWO_SIDED|95.0|-1.608|0.668||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.668|-1.608|0.417
71717699|NCT02722408|142949845|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71717700|NCT02722408|142949845|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in LDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71717701|NCT02722408|142949846|OTHER|||||||0.3646||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3646
71717702|NCT02722408|142949846|OTHER|||||||0.1994||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1994
71717703|NCT02722408|142949846|OTHER|||||||0.2858||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2858
71717704|NCT02722408|142949846|OTHER|||||||0.0829||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0829
71717705|NCT02722408|142949846|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0492
71717706|NCT02722408|142949846|OTHER|||||||0.0442||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0442
71717707|NCT02722408|142949846|OTHER|||||||0.736||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.7360
71717708|NCT02722408|142949846|OTHER|||||||0.6917||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.6917
71717709|NCT02722408|142949846|OTHER|||||||0.7131||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.7131
71717710|NCT02722408|142949846|OTHER|||||||0.0014||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0014
71717711|NCT02722408|142949846|OTHER|||||||0.0009||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0009
71717712|NCT02722408|142949846|OTHER|||||||0.0007||||||Mixed-effects model for repeated measures analysis: Change in LDL-C as dependent variable, visit as fixed effect, patient as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0007
71717713|NCT02722408|142949847|OTHER|||||||0.388||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3880
71717714|NCT02722408|142949847|OTHER|||||||0.2057||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2057
71717715|NCT02722408|142949847|OTHER|||||||0.2892||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2892
71717716|NCT02722408|142949847|OTHER|||||||0.0052||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0052
71717717|NCT02722408|142949847|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.0028
71717718|NCT02722408|142949847|OTHER|||||||0.0026||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.0026
71717719|NCT02722408|142949847|OTHER|||||||0.0493||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0493
71717720|NCT02722408|142949847|OTHER|||||||0.0253||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0253
71717721|NCT02722408|142949847|OTHER|||||||0.0394||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0394
71717722|NCT02722408|142949847|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71717723|NCT02722408|142949847|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71717724|NCT02722408|142949847|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with percent change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71717725|NCT02722408|142949848|OTHER|||||||0.3833||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3833
71717726|NCT02722408|142949848|OTHER|||||||0.2172||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2172
71717727|NCT02722408|142949848|OTHER|||||||0.293||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2930
71717728|NCT02722408|142949848|OTHER|||||||0.1217||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1217
71717729|NCT02722408|142949848|OTHER|||||||0.0901||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0901
71717730|NCT02722408|142949848|OTHER|||||||0.085||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0850
71717731|NCT02722408|142949848|OTHER|||||||0.0747||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0747
71717732|NCT02722408|142949848|OTHER|||||||0.0279||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0279
71717733|NCT02722408|142949848|OTHER|||||||0.0492||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0492
71717734|NCT02722408|142949848|OTHER|||||||0.0003||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0003
71717735|NCT02722408|142949848|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71717736|NCT02722408|142949848|OTHER|||||||0.0002||||||Mixed-effects model for repeated measures analysis with change in Non-HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0002
71717737|NCT02722408|142949849|OTHER|||||||0.8972||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8972
71717738|NCT02722408|142949849|OTHER|||||||0.7867||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7867
71717739|NCT02722408|142949849|OTHER|||||||0.4974||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4974
71717740|NCT02722408|142949849|OTHER|||||||0.5464||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5464
71717741|NCT02722408|142949849|OTHER|||||||0.7668||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7668
71717742|NCT02722408|142949849|OTHER|||||||0.9276||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9276
71717743|NCT02722408|142949849|OTHER|||||||0.5821||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.5821
71717744|NCT02722408|142949849|OTHER|||||||0.8881||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.8881
71768228|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|4.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768229|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.589||0.252|TWO_SIDED|95.0|-1.836|0.482||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.482|-1.836|0.252
71768230|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768231|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.669||0.827|TWO_SIDED|95.0|-1.17|1.462||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.462|-1.170|0.827
71768232|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|4.69|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768233|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|0.33|STANDARD_ERROR_OF_MEAN|0.657||0.615|TWO_SIDED|95.0|-0.962|1.624||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.624|-0.962|0.615
71768234|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.61|||TWO_SIDED|||||||||Week 96||||
71717745|NCT02722408|142949849|OTHER|||||||0.8525||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8525
71717746|NCT02722408|142949849|OTHER|||||||0.0112||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0112
71717747|NCT02722408|142949849|OTHER|||||||0.0018||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0018
71768235|NCT02880956|143037282|SUPERIORITY||LS Mean of Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.678||0.637|TWO_SIDED|95.0|-1.653|1.014||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.014|-1.653|0.637
71768236|NCT02880956|143037282|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|4.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768237|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.367||0.261|TWO_SIDED|95.0|-1.135|0.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.308|-1.135|0.261
71768238|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768239|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|0.29|STANDARD_ERROR_OF_MEAN|0.361||0.423|TWO_SIDED|95.0|-0.42|1.001||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.001|-0.420|0.423
71768240|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768241|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.371||0.322|TWO_SIDED|95.0|-1.097|0.361||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.361|-1.097|0.322
71768242|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|2.48|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768243|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|0.27|STANDARD_ERROR_OF_MEAN|0.397||0.498|TWO_SIDED|95.0|-0.511|1.049||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.049|-0.511|0.498
71717748|NCT02722408|142949849|OTHER|||||||0.0028||||||Mixed-effects model for repeated measures analysis with percent change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0028
71717749|NCT02722408|142949850|OTHER|||||||0.8985||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.8985
71717750|NCT02722408|142949850|OTHER|||||||0.7664||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7664
71717751|NCT02722408|142949850|OTHER|||||||0.4755||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.4755
71717752|NCT02722408|142949850|OTHER|||||||0.2286||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2286
71656983|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-233.22|||<|0.0001|TWO_SIDED|95.0|-332.88|-133.55||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-133.55|-332.88|<0.0001
71656984|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|35.53||||0.5018|TWO_SIDED|95.0|-69.9|140.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||140.96|-69.90|0.5018
71656985|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-24.73||||0.6325|TWO_SIDED|95.0|-128.07|78.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||78.61|-128.07|0.6325
71656986|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-60.26||||0.2427|TWO_SIDED|95.0|-162.72|42.21||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||42.21|-162.72|0.2427
71656987|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|1.05||||0.9834|TWO_SIDED|95.0|-100.5|102.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||102.61|-100.50|0.9834
71656988|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-61.31||||0.2226|TWO_SIDED|95.0|-161.14|38.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||38.52|-161.14|0.2226
71656989|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|268.74|||<|0.0001|TWO_SIDED|95.0|165.98|371.51||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque|||371.51|165.98|<0.0001
71656990|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-293.47|||<|0.0001|TWO_SIDED|95.0|-396.03|-190.91||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-190.91|-396.03|<0.0001
71656991|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-294.53|||<|0.0001|TWO_SIDED|95.0|-395.43|-193.62||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||-193.62|-395.43|<0.0001
71656992|NCT02856880|142831641|SUPERIORITY_OR_OTHER||LS mean difference|-25.78||||0.6086|TWO_SIDED|95.0|-126.53|74.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.|||74.96|-126.53|0.6086
71768244|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768245|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|0.75|STANDARD_ERROR_OF_MEAN|0.386||0.052|TWO_SIDED|95.0|-0.006|1.51||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.510|-0.006|0.052
71768246|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768247|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.398||0.597|TWO_SIDED|95.0|-0.993|0.572||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.572|-0.993|0.597
71768248|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768249|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.376||0.896|TWO_SIDED|95.0|-0.689|0.788||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.788|-0.689|0.896
71768250|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.4|||TWO_SIDED|||||||||Week 72||||
71768251|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|0.53|STANDARD_ERROR_OF_MEAN|0.369||0.149|TWO_SIDED|95.0|-0.192|1.258||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.258|-0.192|0.149
71768252|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768253|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.376||0.522|TWO_SIDED|95.0|-0.98|0.499||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.499|-0.980|0.522
71768254|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|-0.09|STANDARD_DEVIATION|2.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71829082|NCT00346333|143162826|SUPERIORITY_OR_OTHER|||||||0.8||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O'Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over 4 years between the 2 groups.||||0.80
71768255|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.424||0.528|TWO_SIDED|95.0|-1.103|0.567||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.567|-1.103|0.528
71768256|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768257|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|0.3|STANDARD_ERROR_OF_MEAN|0.416||0.474|TWO_SIDED|95.0|-0.519|1.116||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.116|-0.519|0.474
71768258|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768259|NCT02880956|143037283|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.429||0.441|TWO_SIDED|95.0|-1.176|0.513||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.513|-1.176|0.441
71768260|NCT02880956|143037283|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|3.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768261|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.331||0.027|TWO_SIDED|95.0|-1.383|-0.082||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.082|-1.383|0.027
71768262|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|2.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829083|NCT01391130|143162888|SUPERIORITY||Hazard Ratio (HR)|1.2149||||0.4318|TWO_SIDED|95.0|0.7462|1.9779|||Log Rank|||||1.9779|0.7462|0.4318
71768263|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.328||0.146|TWO_SIDED|95.0|-1.123|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.167|-1.123|0.146
71768264|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768265|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.335||0.009|TWO_SIDED|95.0|-1.537|-0.22||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.220|-1.537|0.009
71717753|NCT02722408|142949850|OTHER|||||||0.3975||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3975
71717754|NCT02722408|142949850|OTHER|||||||0.446||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4460
71717755|NCT02722408|142949850|OTHER|||||||0.9414||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9414
71717756|NCT02722408|142949850|OTHER|||||||0.9735||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9735
71717757|NCT02722408|142949850|OTHER|||||||0.9825||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9825
71717758|NCT02722408|142949850|OTHER|||||||0.442||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4420
71768266|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.31|STANDARD_DEVIATION|2.87|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768267|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.333||0.952|TWO_SIDED|95.0|-0.674|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.634|-0.674|0.952
71768268|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|3.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768269|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.324||0.764|TWO_SIDED|95.0|-0.54|0.734||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.734|-0.540|0.764
71717759|NCT02722408|142949850|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
71768270|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|2.85|||TWO_SIDED|||||||||Week 48||||
71768271|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.331||0.103|TWO_SIDED|95.0|-1.191|0.109||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.109|-1.191|0.103
71768272|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.83|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768273|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.362||0.06|TWO_SIDED|95.0|-1.396|0.028||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.028|-1.396|0.060
71768274|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|3.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71717760|NCT02722408|142949850|OTHER|||||||0.0378||||||Mixed-effects model for repeated measures analysis with change in VLDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0378
71717761|NCT02722408|142949851|OTHER|||||||0.2305||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2305
71717762|NCT02722408|142949851|OTHER|||||||0.1836||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1836
71717763|NCT02722408|142949851|OTHER|||||||0.6501||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6501
71717764|NCT02722408|142949851|OTHER|||||||0.0139||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0139
71717765|NCT02722408|142949851|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0077
71717766|NCT02722408|142949851|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
71717767|NCT02722408|142949851|OTHER|||||||0.0507||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0507
71717768|NCT02722408|142949851|OTHER|||||||0.0118||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0118
71717769|NCT02722408|142949851|OTHER|||||||0.0122||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0122
71717770|NCT02722408|142949851|OTHER|||||||0.0077||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0077
71717771|NCT02722408|142949851|OTHER|||||||0.0317||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0317
71717772|NCT02722408|142949851|OTHER|||||||0.0473||||||Mixed-effects model for repeated measures analysis with percent change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH).||||0.0473
71717773|NCT02722408|142949852|OTHER|||||||0.2143||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.2143
71768275|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.36||0.091|TWO_SIDED|95.0|-1.316|0.098||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.098|-1.316|0.091
71768276|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|3.03|||TWO_SIDED|||||||||Week 72||||
71829084|NCT03478696|143162893|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.0154|||TWO_SIDED|95.0|-0.02|0.041|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.041|-0.020|
71829085|NCT03478696|143162894|SUPERIORITY||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0122||0.037|TWO_SIDED|95.0|0.002|0.049||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.049|0.002|0.037
71829086|NCT03478696|143162894|SUPERIORITY||Mean Difference (Net)|0.063|STANDARD_ERROR_OF_MEAN|0.0134|<|0.001|TWO_SIDED|95.0|0.036|0.089||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.089|0.036|<0.001
71829087|NCT03478696|143162894|SUPERIORITY||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.026|0.083||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.083|0.026|<0.001
71829088|NCT03478696|143162894|SUPERIORITY||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.0157||0.001|TWO_SIDED|95.0|0.021|0.082||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.082|0.021|0.001
71829089|NCT03478696|143162895|SUPERIORITY||Mean Difference (Net)|0.004|STANDARD_ERROR_OF_MEAN|0.0098||0.702|TWO_SIDED|95.0|-0.016|0.023||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.023|-0.016|0.702
71768277|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.361||0.12|TWO_SIDED|95.0|-1.274|0.147||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.147|-1.274|0.120
71717774|NCT02722408|142949852|OTHER|||||||0.1874||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1874
71717775|NCT02722408|142949852|OTHER|||||||0.6731||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.6731
71717776|NCT02722408|142949852|OTHER|||||||0.0027||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0027
71717777|NCT02722408|142949852|OTHER|||||||0.002||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0020
71717778|NCT02722408|142949852|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||<0.0001
71717779|NCT02722408|142949852|OTHER|||||||0.0258||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0258
71717780|NCT02722408|142949852|OTHER|||||||0.0044||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0044
71717781|NCT02722408|142949852|OTHER|||||||0.0011||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0011
71717782|NCT02722408|142949852|OTHER|||||||0.0083||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0083
71717783|NCT02722408|142949852|OTHER|||||||0.0314||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0314
71717784|NCT02722408|142949852|OTHER|||||||0.0533||||||Mixed-effects model for repeated measures analysis with change in HDL-C as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0533
71768278|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.19|STANDARD_DEVIATION|2.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768279|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.395||0.429|TWO_SIDED|95.0|-1.09|0.464||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.464|-1.090|0.429
71768280|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|3.13|||TWO_SIDED|||||||||Week 96||||
71768281|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|0.21|STANDARD_ERROR_OF_MEAN|0.389||0.597|TWO_SIDED|95.0|-0.559|0.97||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.970|-0.559|0.597
71768282|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|2.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768283|NCT02880956|143037284|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.86|TWO_SIDED|95.0|-0.717|0.858||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.858|-0.717|0.860
71768284|NCT02880956|143037284|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768285|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.497||0.854|TWO_SIDED|95.0|-1.069|0.885||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.885|-1.069|0.854
71768286|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.02|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768287|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.491||0.412|TWO_SIDED|95.0|-1.368|0.562||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.562|-1.368|0.412
71768288|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|4.08|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768289|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.503||0.262|TWO_SIDED|95.0|-1.554|0.424||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.424|-1.554|0.262
71768290|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.82|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768291|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.571||0.11|TWO_SIDED|95.0|-0.209|2.036||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.036|-0.209|0.110
71768292|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.09|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768293|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.555||0.263|TWO_SIDED|95.0|-1.713|0.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.469|-1.713|0.263
71768294|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768295|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.868|TWO_SIDED|95.0|-1.026|1.217||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.217|-1.026|0.868
71768296|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768297|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.592||0.82|TWO_SIDED|95.0|-1.298|1.029||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.029|-1.298|0.820
71768298|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71829090|NCT03478696|143162896|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.0141||0.244|TWO_SIDED|95.0|-0.011|0.044||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.044|-0.011|0.244
71768299|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.16|STANDARD_ERROR_OF_MEAN|0.583||0.781|TWO_SIDED|95.0|-0.984|1.308||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.308|-0.984|0.781
71768300|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|4.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768301|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.08|STANDARD_ERROR_OF_MEAN|0.59||0.895|TWO_SIDED|95.0|-1.082|1.238||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.238|-1.082|0.895
71768302|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|4.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768303|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|0.69||0.359|TWO_SIDED|95.0|-0.724|1.991||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.991|-0.724|0.359
71768304|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|4.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768305|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.34|STANDARD_ERROR_OF_MEAN|0.675||0.612|TWO_SIDED|95.0|-0.985|1.67||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.670|-0.985|0.612
71768306|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.72|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829091|NCT03615924|143162897|SUPERIORITY||Incidence rate ratio|1.06||||0.7597|TWO_SIDED|95.0|0.75|1.5|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.50|0.75|0.7597
71829092|NCT03615924|143162898|SUPERIORITY||Incidence rate ratio|1.02||||0.9037|TWO_SIDED|95.0|0.72|1.45|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.45|0.72|0.9037
71768307|NCT02880956|143037285|SUPERIORITY||LS Mean of Difference|0.5|STANDARD_ERROR_OF_MEAN|0.696||0.475|TWO_SIDED|95.0|-0.872|1.867||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.867|-0.872|0.475
71887229|NCT04871711|143294875|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.4|30.6||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.6|14.4|<0.001
71717785|NCT02722408|142949853|OTHER|||||||0.3657||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.3657
71717786|NCT02722408|142949853|OTHER|||||||0.1983||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.1983
71717787|NCT02722408|142949853|OTHER|||||||0.297||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.2970
71717788|NCT02722408|142949853|OTHER|||||||0.0092||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.0092
71717789|NCT02722408|142949853|OTHER|||||||0.0049||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.0049
71717790|NCT02722408|142949853|OTHER|||||||0.0033||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.0033
71717791|NCT02722408|142949853|OTHER|||||||0.0618||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0618
71768308|NCT02880956|143037285|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768309|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.427||0.926|TWO_SIDED|95.0|-0.799|0.878||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.878|-0.799|0.926
71717792|NCT02722408|142949853|OTHER|||||||0.0298||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0298
71717793|NCT02722408|142949853|OTHER|||||||0.0352||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0352
71717794|NCT02722408|142949853|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
71768310|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|3.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71717795|NCT02722408|142949853|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71717796|NCT02722408|142949853|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with percent change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71717797|NCT02722408|142949854|OTHER|||||||0.3672||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr||||0.3672
71768311|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.423||0.553|TWO_SIDED|95.0|-1.082|0.58||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.580|-1.082|0.553
71768312|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|3.96|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71717798|NCT02722408|142949854|OTHER|||||||0.2101||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.2101
71717799|NCT02722408|142949854|OTHER|||||||0.3009||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.3009
71717800|NCT02722408|142949854|OTHER|||||||0.1567||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.1567
71717801|NCT02722408|142949854|OTHER|||||||0.1207||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.1207
71717802|NCT02722408|142949854|OTHER|||||||0.1045||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.1045
71717803|NCT02722408|142949854|OTHER|||||||0.0631||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.0631
71717804|NCT02722408|142949854|OTHER|||||||0.0217||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.0217
71768313|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.432||0.69|TWO_SIDED|95.0|-1.021|0.677||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.677|-1.021|0.690
71768314|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768315|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.9|STANDARD_ERROR_OF_MEAN|0.499||0.073|TWO_SIDED|95.0|-0.085|1.879||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.879|-0.085|0.073
71768316|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.22|STANDARD_DEVIATION|4.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768317|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.487||0.517|TWO_SIDED|95.0|-0.641|1.273||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 48||1.273|-0.641|0.517
71768318|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|4.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768319|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.38|STANDARD_ERROR_OF_MEAN|0.501||0.454|TWO_SIDED|95.0|-0.609|1.36||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.360|-0.609|0.454
71717805|NCT02722408|142949854|OTHER|||||||0.0359||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.0359
71717806|NCT02722408|142949854|OTHER|||||||0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0001
71717807|NCT02722408|142949854|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71717808|NCT02722408|142949854|OTHER||||||<|0.0001||||||Mixed-effects model for repeated measures analysis with change in TC as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||<0.0001
71717809|NCT02722408|142949855|OTHER|||||||0.9417||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9417
71717810|NCT02722408|142949855|OTHER|||||||0.7722||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7722
71717811|NCT02722408|142949855|OTHER|||||||0.5283||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5283
71768320|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|4.45|||TWO_SIDED|||||||||Week 48||||
71768321|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.57|STANDARD_ERROR_OF_MEAN|0.522||0.276|TWO_SIDED|95.0|-0.456|1.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.596|-0.456|0.276
71768322|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768323|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.516||0.935|TWO_SIDED|95.0|-0.973|1.058||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.058|-0.973|0.935
71768324|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED|95.0|||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768325|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.04|STANDARD_ERROR_OF_MEAN|0.523||0.942|TWO_SIDED|95.0|-0.99|1.066||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.066|-0.990|0.942
71768326|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.35|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768327|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.569||0.578|TWO_SIDED|95.0|-0.802|1.436||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.436|-0.802|0.578
71829093|NCT03615924|143162899|SUPERIORITY||Incidence rate ratio|0.76||||0.7136|TWO_SIDED|95.0|0.17|3.3|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.30|0.17|0.7136
71829094|NCT03615924|143162900|SUPERIORITY||Incidence rate ratio|0.84||||0.497|TWO_SIDED|95.0|0.5|1.4|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.40|0.50|0.4970
71829095|NCT03615924|143162901|SUPERIORITY||Incidence rate ratio|1.43||||0.1636|TWO_SIDED|95.0|0.87|2.36|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||2.36|0.87|0.1636
71829096|NCT03615924|143162902|SUPERIORITY||Incidence rate ratio|1.68||||0.2011|TWO_SIDED|95.0|0.76|3.75|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||3.75|0.76|0.2011
71768328|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768329|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|0.56|STANDARD_ERROR_OF_MEAN|0.34||0.545|TWO_SIDED|95.0|-0.762|1.441||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|repeated measures model|||Week 96||1.441|-0.762|0.545
71768330|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|3.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768331|NCT02880956|143037286|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.583||0.346|TWO_SIDED|95.0|-1.697|0.597||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.597|-1.697|0.346
71768332|NCT02880956|143037286|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.81|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768333|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.146||0.202|TWO_SIDED|95.0|-0.473|0.1||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.100|-0.473|0.202
71768334|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768335|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.144||0.76|TWO_SIDED|95.0|-0.327|0.239||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.239|-0.327|0.760
71829097|NCT03615924|143162904|SUPERIORITY||Incidence rate ratio|0.0||||0.994|TWO_SIDED|95.0|0.0||Upper limit of confidence interval was not calculable due to 0 events in Ticagrelor 15/30/45 mg bd reporting group.||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.|||0.00|0.9940
71717812|NCT02722408|142949855|OTHER|||||||0.5905||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.5905
71717813|NCT02722408|142949855|OTHER|||||||0.7682||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.7682
71717814|NCT02722408|142949855|OTHER|||||||0.9245||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.9245
71717815|NCT02722408|142949855|OTHER|||||||0.6325||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.6325
71717816|NCT02722408|142949855|OTHER|||||||0.9221||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9221
71717817|NCT02722408|142949855|OTHER|||||||0.8387||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.8387
71717818|NCT02722408|142949855|OTHER|||||||0.0089||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0089
71717819|NCT02722408|142949855|OTHER|||||||0.0013||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0013
71717820|NCT02722408|142949855|OTHER|||||||0.0019||||||Mixed-effects model for repeated measures analysis with percent change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0019
71717821|NCT02722408|142949856|OTHER|||||||0.9195||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Negative LDLr)||||0.9195
71717822|NCT02722408|142949856|OTHER|||||||0.7497||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Negative LDLr)||||0.7497
71717823|NCT02722408|142949856|OTHER|||||||0.5056||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Negative LDLr)||||0.5056
71717824|NCT02722408|142949856|OTHER|||||||0.2468||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Defective LDLr)||||0.2468
71829098|NCT03615924|143162905|SUPERIORITY||Incidence rate ratio|0.77||||0.4822|TWO_SIDED|95.0|0.38|1.58|||Negative binomial model|||Incidence rates, incidence rate ratios, and p-values are from a negative binomial model analysis, with treatment group and baseline hydroxyurea use included in the model as covariates.||1.58|0.38|0.4822
71829099|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-1.6||||0.0133|TWO_SIDED|95.0|-2.87|-0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.34|-2.87|0.0133
71829100|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-2.26||||0.0006|TWO_SIDED|95.0|-3.54|-0.98|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.98|-3.54|0.0006
71829101|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0394|TWO_SIDED|95.0|-3.06|-0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||-0.08|-3.06|0.0394
71717825|NCT02722408|142949856|OTHER|||||||0.392||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Defective LDLr)||||0.3920
71717826|NCT02722408|142949856|OTHER|||||||0.4456||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Defective LDLr)||||0.4456
71829102|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-1.65||||0.0332|TWO_SIDED|95.0|-3.16|-0.13|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.13|-3.16|0.0332
71829103|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-1.82||||0.0601|TWO_SIDED|95.0|-3.71|0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.08|-3.71|0.0601
71829104|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-2.03||||0.0369|TWO_SIDED|95.0|-3.94|-0.12|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.12|-3.94|0.0369
71829105|NCT00880048|143162927|SUPERIORITY||Mean Difference (Net)|-1.67||||0.1122|TWO_SIDED|95.0|-3.73|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.39|-3.73|0.1122
71829106|NCT00880048|143162927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.4713|TWO_SIDED|95.0|-2.85|1.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||1.32|-2.85|0.4713
71829107|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2232|TWO_SIDED|95.0|0.63|7.39|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||7.39|0.63|0.2232
71717827|NCT02722408|142949856|OTHER|||||||0.9203||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Met EAS Clinical Diagnosis of HoFH)||||0.9203
71717828|NCT02722408|142949856|OTHER|||||||0.9704||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Met EAS Clinical Diagnosis of HoFH)||||0.9704
71717829|NCT02722408|142949856|OTHER|||||||0.9755||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Met EAS Clinical Diagnosis of HoFH)||||0.9755
71717830|NCT02722408|142949856|OTHER|||||||0.4213||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28 (Not Met EAS Clinical Diagnosis of HoFH)||||0.4213
71717831|NCT02722408|142949856|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
71717832|NCT02722408|142949856|OTHER|||||||0.03||||||Mixed-effects model for repeated measures analysis with change in TG as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84 (Not Met EAS Clinical Diagnosis of HoFH)||||0.0300
71717833|NCT02722408|142949862|OTHER|||||||0.0294||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300mg: Day 28||||0.0294
71717834|NCT02722408|142949862|OTHER|||||||0.3228||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3228
71717835|NCT02722408|142949862|OTHER|||||||0.5268||||||Mixed-effects model for repeated measures analysis with percent change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5268
71717836|NCT02722408|142949863|OTHER|||||||0.1099||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1099
71717837|NCT02722408|142949863|OTHER|||||||0.5478||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5478
71717838|NCT02722408|142949863|OTHER|||||||0.8837||||||Mixed-effects model for repeated measures analysis with change in hsCRP as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8837
71717839|NCT02722408|142949864|OTHER|||||||0.0587||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0587
71717840|NCT02722408|142949864|OTHER|||||||0.1491||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.1491
71717841|NCT02722408|142949864|OTHER|||||||0.2224||||||Mixed-effects model for repeated measures analysis with percent change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2224
71717842|NCT02722408|142949865|OTHER|||||||0.0959||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0959
71717843|NCT02722408|142949865|OTHER|||||||0.0923||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0923
71717844|NCT02722408|142949865|OTHER|||||||0.1592||||||Mixed-effects model for repeated measures analysis with change in fibrinogen as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.1592
71717845|NCT02722408|142949866|OTHER|||||||0.5856||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.5856
71717846|NCT02722408|142949866|OTHER|||||||0.644||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.6440
71717847|NCT02722408|142949866|OTHER|||||||0.2269||||||Mixed-effects model for repeated measures analysis with percent change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2269
71717848|NCT02722408|142949867|OTHER|||||||0.4814||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4814
71829108|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0559|TWO_SIDED|95.0|0.97|10.2|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||10.2|0.97|0.0559
71717849|NCT02722408|142949867|OTHER|||||||0.5011||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.5011
71717850|NCT02722408|142949867|OTHER|||||||0.4356||||||Mixed-effects model for repeated measures analysis with change in Lipoprotein(a) as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.4356
71717851|NCT02722408|142949868|OTHER|||||||0.0669||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0669
71717852|NCT02722408|142949868|OTHER|||||||0.0189||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0189
71717853|NCT02722408|142949868|OTHER|||||||0.0316||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0316
71717854|NCT02722408|142949869|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0685
71717855|NCT02722408|142949869|OTHER|||||||0.0114||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0114
71717856|NCT02722408|142949869|OTHER|||||||0.0263||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein B as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0263
71768336|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71887230|NCT04871711|143294876|SUPERIORITY||Risk Difference (RD)|19.5|||<|0.001|TWO_SIDED|95.0|12.5|26.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||26.5|12.5|<0.001
71717857|NCT02722408|142949870|OTHER|||||||0.1466||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1466
71717858|NCT02722408|142949870|OTHER|||||||0.3598||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3598
71717859|NCT02722408|142949870|OTHER|||||||0.0685||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0685
71717860|NCT02722408|142949871|OTHER|||||||0.166||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.1660
71768337|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.147||0.419|TWO_SIDED|95.0|-0.409|0.17||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.170|-0.409|0.419
71768338|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|1.03|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768339|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.173||0.893|TWO_SIDED|95.0|-0.363|0.317||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.317|-0.363|0.893
71768340|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|1.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
71768341|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.168||0.886|TWO_SIDED|95.0|-0.306|0.354||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.354|-0.306|0.886
71768342|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71717861|NCT02722408|142949871|OTHER|||||||0.3423||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3423
71717862|NCT02722408|142949871|OTHER|||||||0.0313||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-I as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0313
71717863|NCT02722408|142949872|OTHER|||||||0.7196||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7196
71717864|NCT02722408|142949872|OTHER|||||||0.4343||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4343
71717865|NCT02722408|142949872|OTHER|||||||0.7241||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.7241
71717866|NCT02722408|142949873|OTHER|||||||0.7952||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.7952
71717867|NCT02722408|142949873|OTHER|||||||0.4931||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.4931
71717868|NCT02722408|142949873|OTHER|||||||0.8622||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein A-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.8622
71717869|NCT02722408|142949874|OTHER|||||||0.9823||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.9823
71717870|NCT02722408|142949874|OTHER|||||||0.9129||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.9129
71768343|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.172||0.306|TWO_SIDED|95.0|-0.515|0.162||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.162|-0.515|0.306
71768344|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|1.12|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71717871|NCT02722408|142949874|OTHER|||||||0.7762||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 84||||0.7762
71717872|NCT02722408|142949875|OTHER|||||||0.2683||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2683
71717873|NCT02722408|142949875|OTHER|||||||0.088||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0880
71717874|NCT02722408|142949875|OTHER|||||||0.0165||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-II as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0165
71717875|NCT02722408|142949876|OTHER|||||||0.4585||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.4585
71717876|NCT02722408|142949876|OTHER|||||||0.3721||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.3721
71717877|NCT02722408|142949876|OTHER|||||||0.5305||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.5305
71717878|NCT02722408|142949877|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.2937
71717879|NCT02722408|142949877|OTHER|||||||0.2182||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.2182
71768345|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.116||0.008|TWO_SIDED|95.0|-0.535|-0.079||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.079|-0.535|0.008
71717880|NCT02722408|142949877|OTHER|||||||0.2937||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein C-III as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.2937
71717881|NCT02722408|142949878|OTHER|||||||0.0411||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0411
71717882|NCT02722408|142949878|OTHER|||||||0.0192||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0192
71717883|NCT02722408|142949878|OTHER|||||||0.0445||||||Mixed-effects model for repeated measures analysis with percent change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0445
71717884|NCT02722408|142949879|OTHER|||||||0.0465||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 300 mg: Day 28||||0.0465
71717885|NCT02722408|142949879|OTHER|||||||0.0221||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 600 mg: Day 56||||0.0221
71717886|NCT02722408|142949879|OTHER|||||||0.0402||||||Mixed-effects model for repeated measures analysis with change in Apolipoprotein E as dependent variable, visit as fixed effect, participant as a random effect. Auto-regressive variance-covariance structure was used.|Mixed Models Analysis|||Gemcabene 900 mg: Day 84||||0.0402
71717887|NCT04776161|142949908|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|95.0|-0.16|0.12|||Generalized linear models|Adjusted for age, sex, race||||0.12|-0.16|0.78
71717888|NCT04776161|142949908|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.79|TWO_SIDED|95.0|-0.1|0.13|||Generalized linear models|Adjusted for age, sex, race||||0.13|-0.10|0.79
71717889|NCT04776161|142949909|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.22|TWO_SIDED|95.0|-0.28|1.22|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level.||||1.22|-0.28|0.22
71717890|NCT04776161|142949909|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.24|TWO_SIDED|95.0|-0.33|1.26|||Generalized linear models|Adjusted for age, sex, race and baseline uric acid level||||1.26|-0.33|0.24
71717891|NCT01334554|142949910|SUPERIORITY_OR_OTHER||Beta coefficient (linear regression)|0.12||||0.55|TWO_SIDED|95.0|-0.33|0.58||p- value was unadjusted. Primary outcome underwent logarithmic transformation|Regression, Linear|||H0= 4-week treatment with sildenafil citrate does not improve insulin sensitivity in obese African American women.||0.58|-0.33|0.55
71717892|NCT01334554|142949911|SUPERIORITY_OR_OTHER||Beta coefficient|0.46||||0.649|TWO_SIDED|95.0|-1.58|2.49||Adjusted for baseline values only|Regression, Linear|||||2.49|-1.58|0.649
71717893|NCT02393859|142949926|SUPERIORITY||Normal score|-11.54|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
71717894|NCT02393859|142949926|SUPERIORITY||Normal score|-11.16||||0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
71717895|NCT02393859|142949926|SUPERIORITY||Stratified hazard ratio (HR)|0.36|||||TWO_SIDED|95.0|0.19|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.66|0.19|
71717896|NCT02393859|142949926|SUPERIORITY||Unstratified HR|0.39|||||TWO_SIDED|95.0|0.22|0.7|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.70|0.22|
71717897|NCT02393859|142949926|SUPERIORITY||Stratified HR w/time-dependent covariate|0.36|||||TWO_SIDED|95.0|0.2|0.64|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.64|0.20|
71717898|NCT02393859|142949927|SUPERIORITY||Normal score|-13.9|||<|0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
71717899|NCT02393859|142949927|SUPERIORITY||Normal score|-13.61|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for Blinatumomab relative to HC3 and therefore a longer event free survival time.|||||< 0.001
71717900|NCT02393859|142949927|SUPERIORITY||Stratified HR|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.61|0.20|
71717901|NCT02393859|142949927|SUPERIORITY||Unstratified HR|0.38|||||TWO_SIDED|95.0|0.22|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer EFS for blinatumomab relative to HC3.)|||0.65|0.22|
71829109|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3395|TWO_SIDED|95.0|0.64|3.61|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||3.61|0.64|0.3395
71829110|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4256|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||3.50|0.59|0.4256
71829111|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|1.35||||0.379|TWO_SIDED|95.0|0.69|2.64|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.64|0.69|0.3790
71829112|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2554|TWO_SIDED|95.0|0.76|2.86|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.86|0.76|0.2554
71829113|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|1.53||||0.1961|TWO_SIDED|95.0|0.8|2.91|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.91|0.80|0.1961
71717902|NCT02393859|142949927|SUPERIORITY||Stratified HR w/time-dependent covariate|0.34|||||TWO_SIDED|95.0|0.2|0.59|||||Cox proportional hazard model including time from randomization to allogeneic hematopoietic stem cell transplant. Stratification factors: age and marrow/MRD status. (HR \<1.0=lower average event rate and longer EFS for blinatumomab relative to HC3.)|||0.59|0.20|
71717903|NCT02393859|142949928|SUPERIORITY||Normal score|-10.14||||0.001||||||Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Stratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||0.001
71717904|NCT02393859|142949928|SUPERIORITY||Normal score|-10.32|||<|0.001|||||||Unstratified log-rank test||A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.|||||< 0.001
71717905|NCT02393859|142949928|SUPERIORITY||Stratified HR|0.33|||||TWO_SIDED|95.0|0.16|0.66|||||Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.66|0.16|
71717906|NCT02393859|142949928|SUPERIORITY||Unstratified HR|0.32|||||TWO_SIDED|95.0|0.16|0.65|||||Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)|||0.65|0.16|
71717907|NCT02393859|142949929|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by PCR||||< 0.001
71717908|NCT02393859|142949929|SUPERIORITY||||||<|0.001||||||Cochran-Mantel-Haenszel test adjusting for the stratification factors: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10-3 vs M1 with MRD level ≥ 10-3 vs M2).|Cochran-Mantel-Haenszel|||MRD response by flow cytometry||||< 0.001
71717909|NCT02393859|142949930|SUPERIORITY||Hazard Ratio (HR)|0.29|||||TWO_SIDED|95.0|0.16|0.52|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.)|||0.52|0.16|
71717910|NCT02393859|142949930|SUPERIORITY||Stratified hazard ratio (HR)|0.27|||||TWO_SIDED|95.0|0.15|0.48|||||The subdistribution HR estimates are obtained from the subdistribution Cox model. (HR \< 1.0 indicates a lower average event rate and a longer relapse-free time for blinatumomab relative to HC3.) Stratification factors are age and marrow/MRD status.|||0.48|0.15|
71717911|NCT00954447|142949938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.74|-0.55|||ANCOVA||Linagliptin 5mg - Placebo|||-0.55|-0.74|<0.0001
71717912|NCT00954447|142949939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.935|||<|0.0001||95.0|1.949|4.419|||Regression, Logistic|Logistic regression of HbA1c \< 7.0 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg||4.419|1.949|<0.0001
71717913|NCT00954447|142949941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.51|-0.39|||ANCOVA||Linagliptin 5mg - Placebo|||-0.39|-0.51|<0.0001
71717914|NCT00954447|142949942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.69|-0.52|||ANCOVA||Linagliptin 5mg - Placebo|||-0.52|-0.69|<0.0001
71717915|NCT00954447|142949943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.76|-0.57|||ANCOVA||Linagliptin 5mg - Placebo|||-0.57|-0.76|<0.0001
71717916|NCT00954447|142949944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.67|-0.47|||ANCOVA||Linagliptin 5mg - Placebo|||-0.47|-0.67|<0.0001
71717917|NCT00954447|142949945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.65|-0.45|||ANCOVA||Linagliptin 5mg - Placebo|||-0.45|-0.65|<0.0001
71717918|NCT00954447|142949946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.64|-0.43|||ANCOVA||Linagliptin 5mg - Placebo|||-0.43|-0.64|<0.0001
71717919|NCT00954447|142949947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001||95.0|-16.49|-6.71|||ANCOVA||Linagliptin 5mg - Placebo|||-6.71|-16.49|<0.0001
71717920|NCT00954447|142949950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.53||0.0029||95.0|-2.61|-0.54|||ANCOVA||Linagliptin 5mg - Placebo|||-0.54|-2.61|0.0029
71717921|NCT00954447|142949953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.327|||<|0.0001||95.0|2.221|8.43|||Regression, Logistic|Logistic regression of HbA1c \< 6.5 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c \>= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg||8.430|2.221|<0.0001
71717922|NCT00980148|142950020|NON_INFERIORITY_OR_EQUIVALENCE|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.|Risk Difference (RD)|3.2|||||ONE_SIDED|90.0||5.9|||||The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.||5.9||
71829114|NCT00880048|143162928|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6916|TWO_SIDED|95.0|0.58|2.25|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.25|0.58|0.6916
71829115|NCT00880048|143162929|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.61|TWO_SIDED|95.0|0.5|1.95|||Log Rank|||||1.95|0.50|0.61
71829116|NCT00880048|143162929|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.35|TWO_SIDED|95.0|0.36|1.54|||Log Rank|||||1.54|0.36|0.35
71717923|NCT01747915|142950028|SUPERIORITY||Least Square (LS) Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.088||0.8121|TWO_SIDED|95.0|-0.15|0.19|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.19|-0.15|0.8121
71717924|NCT01747915|142950028|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.8889|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.||0.16|-0.19|0.8889
71717925|NCT01747915|142950029|SUPERIORITY||Odds Ratio (OR)|1.095||||0.7973|TWO_SIDED|95.0|0.548|2.186||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||2.186|0.548|0.7973
71717926|NCT01747915|142950029|SUPERIORITY||Odds Ratio (OR)|0.934||||0.8474|TWO_SIDED|95.0|0.465|1.877||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic|||||1.877|0.465|0.8474
71768346|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.26|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768347|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.115||0.031|TWO_SIDED|95.0|-0.474|-0.023||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.023|-0.474|0.031
71768348|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.16|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71829117|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.69||||0.0362|TWO_SIDED|95.0|-1.34|-0.04|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||-0.04|-1.34|0.0362
71829118|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.81||||0.0155|TWO_SIDED|95.0|-1.46|-0.16|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.16|-1.46|0.0155
71717927|NCT00887159|142950039|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.45|TWO_SIDED|95.0|0.65|1.47||P-value is one-sided.|Regression, Cox||The hazard ratio was derived comparing Arm B to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.47|0.65|0.45
71717928|NCT00887159|142950039|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.48|TWO_SIDED|95.0|0.66|1.48||P-value is one-sided.|Regression, Cox||Hazard ratio was derived comparing Arm C to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.||1.48|0.66|0.48
71717929|NCT00887159|142950042|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.69||||0.01|TWO_SIDED|95.0|1.13|2.52|||Regression, Cox||Hazard ratio was derived comparing the high CTCs group to the low CTCs group.|||2.52|1.13|0.01
71717930|NCT03420742|142950052|OTHER||Geometric least squares mean ratio|0.741|||||TWO_SIDED|90.0|0.6|0.915|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||0.915|0.600|
71717931|NCT03420742|142950053|OTHER||Geometric least squares mean ratio|0.836|||||TWO_SIDED|90.0|0.662|1.06|||||The ratios of geometric mean were calculated on the basis of the within-participant variance. Participant was treated as a random effect in the model.|||1.06|0.662|
71717932|NCT01119443|142950076|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.2|||||TWO_SIDED|90.0|98.3|110.3|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.3|98.3|
71717933|NCT01119443|142950077|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.8||||||90.0|100.1|109.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.8|100.1|
71768349|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.116||0.014|TWO_SIDED|95.0|-0.514|-0.059||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||-0.059|-0.514|0.014
71768350|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.25|STANDARD_DEVIATION|1.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|||||
71768351|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.135||0.065|TWO_SIDED|95.0|-0.514|0.016||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.016|-0.514|0.065
71768352|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829119|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.46||||0.2593|TWO_SIDED|95.0|-1.27|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.34|-1.27|0.2593
71829120|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.62||||0.1407|TWO_SIDED|95.0|-1.44|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-1.44|0.1407
71829121|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.67||||0.1933|TWO_SIDED|95.0|-1.67|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.34|-1.67|0.1933
71717934|NCT01119443|142950078|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|108.31|||||TWO_SIDED|90.0|95.634|122.676|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.676|95.634|
71717935|NCT01119443|142950079|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|106.85|||||TWO_SIDED|90.0|93.189|122.251|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||122.251|93.189|
71717936|NCT01119443|142950080|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|98.426|||||TWO_SIDED|90.0|84.276|112.58|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.58|84.276|
71717937|NCT01119443|142950081|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|95.11|||||TWO_SIDED|90.0|82.461|109.698|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||109.698|82.461|
71717938|NCT01119443|142950083|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.07|||||TWO_SIDED|90.0|91.585|118.263|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||118.263|91.585|
71717939|NCT01119443|142950084|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|93.6||||||90.0|86.9|100.8|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||100.8|86.9|
71717940|NCT01119443|142950085|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|100.2|||||TWO_SIDED|90.0|94.0|106.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||106.7|94.0|
71717941|NCT01119443|142950086|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
71717942|NCT01119443|142950087|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||TWO_SIDED|90.0|73.583|101.854|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.854|73.583|
71717943|NCT01119443|142950088|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|99.069|||||TWO_SIDED|90.0|80.688|117.45|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||117.45|80.688|
71717944|NCT01119443|142950089|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|109.48|||||TWO_SIDED|90.0|89.571|133.811|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||133.811|89.571|
71829122|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.74||||0.15|TWO_SIDED|95.0|-1.76|0.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||0.27|-1.76|0.1500
71829123|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-1.09||||0.055|TWO_SIDED|95.0|-2.21|0.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.02|-2.21|0.0550
71717945|NCT01119443|142950091|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|92.63|||||TWO_SIDED|90.0|77.871|110.185|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||110.185|77.871|
71717946|NCT00775268|142950128|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
71717947|NCT00775268|142950129|SUPERIORITY|||||||0.0313|||||||Wilcoxon matched-pairs signed rank test|||||||0.0313
71829124|NCT00880048|143162930|SUPERIORITY||Mean Difference (Net)|-0.52||||0.3627|TWO_SIDED|95.0|-1.65|0.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.61|-1.65|0.3627
71887231|NCT04871711|143294877|SUPERIORITY||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|30.9||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||30.9|12.4|<0.001
71768353|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.132||0.121|TWO_SIDED|95.0|-0.465|0.055||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.055|-0.465|0.121
71768354|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|1.05|STANDARD_DEVIATION|1.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829125|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.03||||0.0616|TWO_SIDED|95.0|-2.11|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-2.11|0.0616
71829126|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-2.28|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-1.19|-3.36|<0.0001
71829127|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.44||||0.0239|TWO_SIDED|95.0|-2.68|-0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||-0.19|-2.68|0.0239
71829128|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.84||||0.0048|TWO_SIDED|95.0|-3.12|-0.57|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||-0.57|-3.12|0.0048
71829129|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.58||||0.027|TWO_SIDED|95.0|-2.97|-0.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||-0.18|-2.97|0.0270
71717948|NCT01194245|142950145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.|LS Means Difference|0.05||||0.2878|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.||0.15|-0.05|0.2878
71717949|NCT05069649|142950173|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
71717950|NCT05069649|142950174|SUPERIORITY|||||||0.2488|||||||Fisher Exact|||||||0.2488
71768355|NCT02880956|143037287|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.136||0.21|TWO_SIDED|95.0|-0.438|0.097||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.097|-0.438|0.210
71717951|NCT05069649|142950175|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71768356|NCT02880956|143037287|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|1.0|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768357|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.188||0.303|TWO_SIDED|95.0|-0.564|0.176||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.176|-0.564|0.303
71768358|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768359|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.186||0.358|TWO_SIDED|95.0|-0.536|0.194||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.194|-0.536|0.358
71768360|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71887232|NCT04871711|143294878|SUPERIORITY||Risk Difference (RD)|23.9|||<|0.001|TWO_SIDED|95.0|15.2|32.7||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||32.7|15.2|<0.001
71717952|NCT05069649|142950176|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||0.32
71717953|NCT05069649|142950177|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
71717954|NCT05069649|142950178|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71717955|NCT03800030|142950189|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.305||||||0.031
71717956|NCT03800030|142950190|SUPERIORITY|||||||0.935|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 0.083||||||0.935
71717957|NCT03800030|142950191|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 1.833||||||0.040
71717958|NCT03800030|142950192|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 2.174||||||0.020
71717959|NCT03800030|142950193|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = -0.623||||||0.540
71717960|NCT03800030|142950194|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.989||||||0.007
71717961|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|2.11||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR4521||||0.010
71717962|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|0.56||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR107||||0.010
71717963|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|2.57||||0.018|TWO_SIDED||||||t-test, 2 sided|||miR-891a||||0.018
71717964|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|0.88||||0.021|TWO_SIDED||||||t-test, 2 sided|||miR363||||0.021
71717965|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-1.0||||0.028|TWO_SIDED||||||t-test, 2 sided|||miR1248||||0.028
71717966|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-0.85||||0.033|TWO_SIDED||||||t-test, 2 sided|||miR944||||0.033
71717967|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|2.13||||0.034|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.034
71717968|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|0.39||||0.036|TWO_SIDED||||||t-test, 2 sided|||miR103a||||0.036
71717969|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|1.69||||0.037|TWO_SIDED||||||t-test, 2 sided|||miR454||||0.037
71768361|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.347|TWO_SIDED|95.0|-0.553|0.195||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.195|-0.553|0.347
71768362|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|1.21|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768363|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.494|TWO_SIDED|95.0|-0.205|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.205|0.494
71887233|NCT04871711|143294879|SUPERIORITY||Risk Difference (RD)|19.6|||<|0.001|TWO_SIDED|95.0|11.8|27.5||Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||27.5|11.8|<0.001
71887234|NCT04871711|143294880|SUPERIORITY||Risk Difference (RD)|17.2|||<|0.001|TWO_SIDED|95.0|10.1|24.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||24.3|10.1|<0.001
71887235|NCT04871711|143294881|SUPERIORITY||Risk Difference (RD)|25.7|||<|0.001|TWO_SIDED|95.0|17.2|34.3||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||34.3|17.2|<0.001
71717970|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-1.13||||0.041|TWO_SIDED||||||t-test, 2 sided|||miR320e||||0.041
71717971|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-0.55||||0.043|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.043
71717972|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|1.95||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR130b||||0.044
71717973|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-2.18||||0.044|TWO_SIDED||||||t-test, 2 sided|||miR365a||||0.044
71717974|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|2.06||||0.047|TWO_SIDED||||||t-test, 2 sided|||miR135b||||0.047
71717975|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-2.35||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR1273h||||0.048
71717976|NCT02230189|142950195|SUPERIORITY||Mean Difference (Net)|-1.31||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR3177||||0.048
71717977|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-1.83||||0|TWO_SIDED||||||t-test, 2 sided|||miR6510||||0.0
71717978|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-2.09||||0|TWO_SIDED||||||t-test, 2 sided|||miR3605||||0
71717979|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-5.75||||0|TWO_SIDED||||||t-test, 2 sided|||miR3912||||0
71717980|NCT02230189|142950196|SUPERIORITY||Median Difference (Net)|1.93||||0|TWO_SIDED||||||t-test, 2 sided|||miR15b||||0
71717981|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-2.35||||0|TWO_SIDED||||||t-test, 2 sided|||miR127||||0
71717982|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.59||||0|TWO_SIDED||||||t-test, 2 sided|||miR146a||||0
71717983|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.21||||0|TWO_SIDED||||||t-test, 2 sided|||miR449b||||0
71717984|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|0.85||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21-5p||||0.01
71717985|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-1.29||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6842||||0.01
71717986|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR142-5p||||0.01
71717987|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.67||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR21||||0.01
71717988|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-4.24||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR493||||0.01
71717989|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-1.46||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR193a||||0.01
71717990|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.89||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR149||||0.01
71717991|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.06||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR449a||||0.01
71717992|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-2.1||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6511a||||0.01
71717993|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-1.59||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR6843||||0.01
71717994|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.95||||0.01|TWO_SIDED||||||t-test, 2 sided|||miR671||||0.01
71717995|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-4.65||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6503||||0.02
71717996|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|2.84||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR450b||||0.02
71717997|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-4.92||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR485||||0.02
71717998|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-2.49||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR6806||||0.02
71717999|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|2.18||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3182||||0.02
71718000|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.28||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR142-3p||||0.02
71718001|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-1.23||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR320d||||0.02
71718002|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|2.73||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR3928||||0.02
71718003|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|4.59||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR744||||0.02
71718004|NCT02230189|142950196|SUPERIORITY||Median Difference (Net)|3.42||||0.02|TWO_SIDED||||||t-test, 2 sided|||miR206||||0.02
71718005|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|0.9||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR30e||||0.03
71718006|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR4500||||0.03
71718007|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.98||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR125a||||0.03
71718008|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.6||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR99b||||0.03
71718009|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|2.67||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1||||0.03
71887236|NCT04871711|143294882|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|15.5|33.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.0|15.5|<0.001
71887237|NCT04871711|143294883|SUPERIORITY||Mean Difference (Net)|-35.2|||<|0.001|TWO_SIDED|95.0|-46.7|-23.8||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-23.8|-46.7|<0.001
71887238|NCT04871711|143294884|SUPERIORITY||Mean Difference (Net)|-3.6|||<|0.001|TWO_SIDED|95.0|-4.7|-2.6||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-2.6|-4.7|<0.001
71887239|NCT04871711|143294885|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.2|<0.001
71887240|NCT04871711|143294886|SUPERIORITY||Mean Difference (Net)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.3|-1.2||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.2|-2.3|<0.001
71887241|NCT04871711|143294887|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.0||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-1.0|-2.1|<0.001
71887242|NCT04871711|143294888|SUPERIORITY||Mean Difference (Net)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.45||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.45|-0.83|<0.001
71718010|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.77||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.03
71718011|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-3.17||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR1255a||||0.03
71718012|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.02||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR223||||0.03
71718013|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.78||||0.03|TWO_SIDED||||||t-test, 2 sided|||miR642a||||0.03
71718014|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|2.17||||0.4|TWO_SIDED||||||t-test, 2 sided|||miR548ae||||0.4
71718015|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.79||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR146b||||0.04
71718016|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-2.52||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR877||||0.04
71718017|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-0.69||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR181a||||0.04
71718018|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-3.4||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR4467||||0.04
71718019|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-2.48||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR1249||||0.04
71718020|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|3.87||||0.04|TWO_SIDED||||||t-test, 2 sided|||miR766||||0.04
71718021|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|1.07||||0.048|TWO_SIDED||||||t-test, 2 sided|||miR29c||||0.048
71718022|NCT02230189|142950196|SUPERIORITY||Mean Difference (Net)|-1.75||||-1.75|TWO_SIDED||||||t-test, 2 sided|||miR370||||-1.75
71718023|NCT01074125|142950197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3376|||<|0.0001|TWO_SIDED||||||Regression, Linear|||To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05||||<0.0001
71718024|NCT01824290|142950240|SUPERIORITY||Mean Difference (Final Values)|23.88|STANDARD_ERROR_OF_MEAN|29.114|||TWO_SIDED|80.0|-14.25|62.0||||||||62.00|-14.25|
71718025|NCT00527618|142950246|SUPERIORITY_OR_OTHER||Slope|-0.27|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||Mixed Models Analysis|Adjusted for baseline plasma HIV-1 RNA.|Acyclovir was coded as 0 and valacyclovir as 1. The beta-coefficient (slope) indicates the average difference in HIV-1 RNA on valacyclovir and acyclovir; a negative number indicates that plasma HIV-1 RNA was lower on valacyclovir than acyclovir.|We estimated that a sample size of 29 participants, with 4 weeks of weekly plasma HIV-1 RNA levels per treatment arm, would be required to detect a 0.25 log10 copies/ml difference in plasma HIV-1 RNA between the study arms with 80% power, at a two-sided type I error rate of 5%.||-0.14|-0.41|<0.001
71718026|NCT00527618|142950247|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.78|TWO_SIDED|95.0|0.66|1.37|||Random effects poission regression|Adjusted for age.||We estimated that 26 participants would be required to detect a 50% reduction in genital HSV shedding with 80% power, at a two-sided type I error rate of 5%.||1.37|0.66|0.78
71718027|NCT00527618|142950248|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71718028|NCT00527618|142950249|SUPERIORITY_OR_OTHER|||||||0.67|||||||Mixed Models Analysis|||||||0.67
71718029|NCT02706925|142950252|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2951|STANDARD_DEVIATION|0.0352|||TWO_SIDED|95.0|1.2242|1.366|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.3660|1.2242|
71718030|NCT02706925|142950252|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.088|STANDARD_DEVIATION|0.0843|||TWO_SIDED|95.0|0.9128|1.2633|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2633|0.9128|
71718031|NCT02706925|142950252|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1846|STANDARD_DEVIATION|0.3328|||TWO_SIDED|95.0|0.4791|1.89|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.8900|0.4791|
71718032|NCT02706925|142950253|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2114|STANDARD_DEVIATION|0.035|||TWO_SIDED|95.0|1.1409|1.2818|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.2818|1.1409|
71718033|NCT02706925|142950253|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0771|STANDARD_DEVIATION|0.0524|||TWO_SIDED|95.0|0.9696|1.1845|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||1.1845|0.9696|
71718034|NCT02706925|142950253|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3969|STANDARD_DEVIATION|0.3965|||TWO_SIDED|95.0|0.5563|2.2375|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.|||2.2375|0.5563|
71718035|NCT00363311|142950256|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.56||||0.009||95.0|0.36|0.87||Statistical data are for Year 1.5|Log Rank|||||0.87|0.36|0.009
71768364|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.09|STANDARD_DEVIATION|1.22|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768365|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.156||0.454|TWO_SIDED|95.0|-0.189|0.423||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.423|-0.189|0.454
71718036|NCT00363311|142950256|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.61||||0.007||95.0|0.43|0.88||Statistical data are for Overall (Years 0-3)|Log Rank|||||0.88|0.43|0.007
71718037|NCT00363311|142950257|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.46||||0.13||95.0|0.16|1.31||Statistical data are for Year 1.5|Log Rank|||||1.31|0.16|0.13
71718038|NCT00363311|142950257|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.48||||0.053||95.0|0.22|1.03||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.03|0.22|0.053
71718039|NCT00363311|142950258|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59||||0.031||95.0|0.36|0.96||Statistical data are for Year 1.5|Log Rank|||||0.96|0.36|0.031
71718040|NCT00363311|142950258|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.7||||0.079||95.0|0.46|1.05||Statistical data are for Overall (Years 0-3)|Log Rank|||||1.05|0.46|0.079
71718041|NCT00363311|142950259|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Fisher Exact|||||||0.65
71768366|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71718042|NCT00363311|142950260|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
71718043|NCT00363311|142950267|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
71718044|NCT00363311|142950268|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.039
71718045|NCT00363311|142950270|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.80
71718046|NCT00363311|142950271|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||||||0.12
71718047|NCT00120627|142950289|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|F (1,144) = 4.12, p \< .05||2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA||||<0.05
71718048|NCT00120627|142950289|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71768367|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_DEVIATION|0.16||0.644|TWO_SIDED|95.0|-0.24|0.388||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.388|-0.240|0.644
71768368|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.07|STANDARD_DEVIATION|1.1|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71718049|NCT00120627|142950290|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.||||<0.05
71718050|NCT00120627|142950291|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)||||<0.0001
71718051|NCT00120627|142950292|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71718052|NCT00120627|142950292|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mediation using Sobel Test|||||||<0.001
71718053|NCT00120627|142950293|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||<0.01
71718054|NCT00120627|142950294|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA||||< 0.05
71718055|NCT00120627|142950295|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Depression Subscale||||<0.001
71718056|NCT00120627|142950295|SUPERIORITY_OR_OTHER||||||=|0.31|TWO_SIDED||||||ANOVA|||Anxiety Subscale||||=0.31
71768369|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.09|STANDARD_ERROR_OF_MEAN|0.232||0.685|TWO_SIDED|95.0|-0.363|0.551||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.551|-0.363|0.685
71768370|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|1.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768371|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.28|STANDARD_ERROR_OF_MEAN|0.228||0.219|TWO_SIDED|95.0|-0.168|0.73||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.730|-0.168|0.219
71768372|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|1.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768373|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.232||0.507|TWO_SIDED|95.0|-0.302|0.61||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.610|-0.302|0.507
71768374|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.1|STANDARD_DEVIATION|1.49|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71829130|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.86||||0.0103|TWO_SIDED|95.0|-3.27|-0.44|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.44|-3.27|0.0103
71829131|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.53||||0.0497|TWO_SIDED|95.0|-3.06|0.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.00|-3.06|0.0497
71718057|NCT00120627|142950295|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||ANOVA|||Somatization Subscale||||=0.44
71718058|NCT00120627|142950296|SUPERIORITY_OR_OTHER||||||=|0.66|TWO_SIDED||||||ANOVA|||Post-hoc analysis||||=0.66
71718059|NCT00120627|142950297|SUPERIORITY_OR_OTHER||||||=|0.18|TWO_SIDED||||||ANOVA|||||||= 0.18
71718060|NCT00120627|142950298|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||||||< 0.01
71718061|NCT01595529|142950305|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.035569|||||ONE_SIDED|95.0||0.054844||||||||0.054844||
71718062|NCT01595529|142950306|NON_INFERIORITY|The primary analysis was a non-inferiority test comparing the proportion of subjects with symptomatic UTIs at the TOC visit to evaluate whether the difference was within the 5% equivalence interval. This test was conducted by calculating the one-sided 95% upper confidence limit for the difference in symptomatic UTI (treatment failure) rate. If this limit was less than or equal to the equivalence interval (0.05), then would conclude that short course therapy is not inferior to standard therapy.|Risk Difference (RD)|0.022169|||||ONE_SIDED|95.0||0.03939||||||||0.03939||
71718063|NCT01595529|142950307|SUPERIORITY||Risk Difference (RD)|-0.00356|||||TWO_SIDED|95.0|-0.03323|0.026102||||||||0.026102|-0.03323|
71718064|NCT01595529|142950308|SUPERIORITY||Risk Difference (RD)|-0.00994|||||TWO_SIDED|95.0|-0.04012|0.020236||||||||0.020236|-0.04012|
71768375|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.216||0.233|TWO_SIDED|95.0|-0.683|0.167||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.167|-0.683|0.233
71768376|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|1.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768377|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.211||0.881|TWO_SIDED|95.0|-0.383|0.446||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.446|-0.383|0.881
71829132|NCT00880048|143162931|SUPERIORITY||Mean Difference (Net)|-1.41||||0.0794|TWO_SIDED|95.0|-2.98|0.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.17|-2.98|0.0794
71829133|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.28||||0.24|TWO_SIDED|95.0|-0.75|0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.19|-0.75|0.2400
71718065|NCT01595529|142950309|SUPERIORITY|||||||0.2282|||||||Chi-squared|||At Test of Cure Visit||||0.2282
71718066|NCT01595529|142950309|SUPERIORITY|||||||0.4876|||||||Chi-squared|||At Outcome Assessment Visit||||0.4876
71718067|NCT01595529|142950310|SUPERIORITY|||||||0.4184|||||||Chi-squared|||At Test of Cure Visit||||0.4184
71718068|NCT01595529|142950310|SUPERIORITY|||||||0.9782|||||||Chi-squared|||At Outcome Assessment Visit||||0.9782
71718069|NCT01595529|142950311|SUPERIORITY||Risk Difference (RD)|-0.05277|||||TWO_SIDED|95.0|-0.08857|-0.01698||||||||-0.01698|-0.08857|
71718070|NCT01595529|142950312|SUPERIORITY||Risk Difference (RD)|-0.05664|||||TWO_SIDED|95.0|-0.09479|-0.0185||||||||-0.01850|-0.09479|
71718071|NCT01595529|142950313|SUPERIORITY||Risk Difference (RD)|-0.03056|||||TWO_SIDED|95.0|-0.07744|0.016323||||||||0.016323|-0.07744|
71718072|NCT01595529|142950314|SUPERIORITY||Risk Difference (RD)|-0.01094|||||TWO_SIDED|95.0|-0.058|0.036117||||||||0.036117|-0.0580|
71718073|NCT01595529|142950315|SUPERIORITY||Risk Difference (RD)|-0.10373|||||TWO_SIDED|95.0|-0.14161|-0.06585||||||||-0.06585|-0.14161|
71768378|NCT02880956|143037288|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|1.42|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71718074|NCT01595529|142950316|SUPERIORITY||Risk Difference (RD)|-0.09198|||||TWO_SIDED|95.0|-0.13006|-0.05391||||||||-0.05391|-0.13006|
71718075|NCT04067492|142950389|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|28.63||||0.1331|TWO_SIDED|95.0|4.21|53.05||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||53.05|4.21|0.1331
71718076|NCT04067492|142950389|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|-2.05||||0.1331|TWO_SIDED|95.0|-30.6|26.5||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||26.50|-30.60|0.1331
71718077|NCT04067492|142950389|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|16.7||||0.1331|TWO_SIDED|95.0|-12.67|46.08||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||46.08|-12.67|0.1331
71738994|NCT00620113|142990735|SUPERIORITY_OR_OTHER||Difference in LS Means|-37.45||||0.001|TWO_SIDED|95.0|-60.32|-14.59||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-14.59|-60.32|0.001
71768379|NCT02880956|143037288|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.217||0.671|TWO_SIDED|95.0|-0.52|0.335||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.335|-0.520|0.671
71768380|NCT02880956|143037288|OTHER||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|1.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768381|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.409||0.297|TWO_SIDED|95.0|-1.232|0.377||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.377|-1.232|0.297
71768382|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|3.7|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768383|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.405||0.979|TWO_SIDED|95.0|-0.808|0.786||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.786|-0.808|0.979
71768384|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|3.63|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71718078|NCT04067492|142950389|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|3.12||||0.1331|TWO_SIDED|95.0|-25.1|31.33||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\]|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||31.33|-25.10|0.1331
71718079|NCT04067492|142950389|OTHER|"The study was planned to randomize 85 patients: 15 patients in the RPH-104 4 mg group, and 14 patients in the RPH-104 20 mg, 40 mg, 80 mg and 160 mg groups each, a total of 14 patients in the Voltaren® (diclofenac) group.~The sample size was calculated assuming a standard deviation of 26 mm for change in pain intensity at 72 hours."|Mean Difference (Final Values)|5.96||||0.1331|TWO_SIDED|95.0|-24.22|36.14||p-value, group|ANCOVA||Adjusted mean difference. Comparison with the control group \[RPH-104 - Diclofenac\].|It was assumed that the sample size would allow constructing a 95% CI around the mean change in pain intensity at 72 hours after the start of the investigational product use in each group with an accuracy of 30 mm change in pain intensity and would reveal statistically significant differences between the groups in pairwise comparisons, without control for type I error for multiple comparisons, taking into account the type I error α = 5%, if the difference between the compared groups is ≥ 20 mm.||36.14|-24.22|0.1331
71718080|NCT04067492|142950396|OTHER|||||||0.5995|||||||Log Rank|||||||0.5995
71718081|NCT04067492|142950396|OTHER|||||||0.9012|||||||Log Rank|||||||0.9012
71718082|NCT04067492|142950398|OTHER||difference in proportions|63.5||||0.0066|TWO_SIDED|95.0|19.9|88.6|||Fisher Exact|||||88.6|19.9|0.0066
71718083|NCT04067492|142950398|OTHER||difference in proportions|-5.6|||>|0.9999|TWO_SIDED|95.0|-50.1|45.5|||Fisher Exact|||||45.5|-50.1|>0.9999
71718084|NCT04067492|142950398|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
71768385|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.415||0.663|TWO_SIDED|95.0|-0.996|0.634||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.634|-0.996|0.663
71768386|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.05|STANDARD_DEVIATION|3.71|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768387|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.636||0.961|TWO_SIDED|95.0|-1.22|1.282||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.282|-1.220|0.961
71768388|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.88|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768389|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.617||0.833|TWO_SIDED|95.0|-1.083|1.344||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.344|-1.083|0.833
71718085|NCT04067492|142950398|OTHER||difference in proportions|27.8||||0.3287|TWO_SIDED|95.0|-26.8|71.8|||Fisher Exact|||||71.8|-26.8|0.3287
71718086|NCT04067492|142950398|OTHER||difference in proportions|17.8||||0.5804|TWO_SIDED|95.0|-33.7|67.8|||Fisher Exact|||||67.8|-33.7|0.5804
71718087|NCT00833027|142950420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.85|<|0.001|ONE_SIDED|95.0|||||Student's T-test|Student's T-test for paired samples||||||<0.001
71718088|NCT00553410|142950434|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.31|TWO_SIDED|95.0|0.93|1.26|||Log Rank|||||1.26|.93|.31
71718089|NCT00553410|142950435|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.16|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|.68|.16
71718090|NCT00553410|142950436|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.25|TWO_SIDED|95.0|0.71|1.09|||Log Rank|||||1.09|.71|.25
71829134|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.76||||0.002|TWO_SIDED|95.0|-1.23|-0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.28|-1.23|0.0020
71829135|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.15||||0.5605|TWO_SIDED|95.0|-0.67|0.36|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.36|-0.67|0.5605
71718091|NCT00553410|142950437|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|.81|.84
71718092|NCT04683913|142950445|OTHER||||||<|0.001|||||||ANCOVA|alpha=0.05||||||<0.001
71768390|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|0.03|STANDARD_DEVIATION|5.06|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829136|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.33||||0.2215|TWO_SIDED|95.0|-0.86|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.20|-0.86|0.2215
71768391|NCT02880956|143037289|OTHER||LS Mean of Difference|0.23|STANDARD_ERROR_OF_MEAN|0.636||0.714|TWO_SIDED|95.0|-1.017|1.484||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.484|-1.017|0.714
71768392|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|5.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829137|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.35||||0.287|TWO_SIDED|95.0|-1.01|0.3|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.30|-1.01|0.2870
71718093|NCT04683913|142950446|OTHER|||||||0.027||||||Week 1\&2 vs Week 3\&4|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.027
71718094|NCT04683913|142950446|OTHER|||||||1||||||Week 3\&4 vs Week 5\&6|t-test, 2 sided|||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
71718095|NCT04683913|142950446|OTHER|||||||0.078||||||Week 5\&6 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.078
71718096|NCT04683913|142950446|OTHER|||||||0.015||||||Follow up vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.015
71718097|NCT04683913|142950446|OTHER|||||||0.567||||||Week 1\&2 vs Week 5\&6|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.567
71718098|NCT04683913|142950446|OTHER|||||||0.001||||||Week 1\&2 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.001
71718099|NCT04683913|142950446|OTHER|||||||1||||||Week 1\&2 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||1.0
71718100|NCT04683913|142950446|OTHER|||||||0.205||||||Week 3\&4 vs Follow up|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.205
71718101|NCT04683913|142950446|OTHER|||||||0.162||||||Week 3\&4 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.162
71768393|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.663||0.518|TWO_SIDED|95.0|-1.733|0.876||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.876|-1.733|0.518
71768394|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|5.17|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768395|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.654||0.633|TWO_SIDED|95.0|-1.598|0.973||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.973|-1.598|0.633
71718102|NCT04683913|142950446|OTHER|||||||0.421||||||Week 5\&6 vs Retention|t-test, 2 sided|alpha corrected with Bonferroni-Dunn procedure (k=10).||The change in foot progression angle magnitude at each sequential time point were compared using paired t-tests (with a Bonferroni-Dunn correction). Results indicate whether the change from baseline were significantly different at each time point. Abbreviations: F=Follow up, R=Retention||||0.421
71718103|NCT04683913|142950451|SUPERIORITY|||||||0.75|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - pain subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.750
71768396|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.06|STANDARD_DEVIATION|4.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71656993|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|-273.92||||0.6664|TWO_SIDED|95.0|-1550.45|1002.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1002.61|-1550.45|0.6664
71718104|NCT04683913|142950451|SUPERIORITY|||||||0.201|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - stiffness subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.201
71768397|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.661||0.776|TWO_SIDED|95.0|-1.488|1.112||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.112|-1.488|0.776
71768398|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|4.93|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71718105|NCT04683913|142950451|SUPERIORITY|||||||0.997|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - physical function subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.997
71718106|NCT04683913|142950451|SUPERIORITY|||||||0.423|||||||ANCOVA|Controlling for baseline scores, structural severity and sex. alpha=0.05||Knee Injury and Osteoarthritis Outcome Scale - quality of life subscale scores were compared between the delayed and immediate groups at week 6 using ANCOVA.||||0.423
71718107|NCT04683913|142950452|SUPERIORITY|||||||0.342|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment 1 (early stance) was analyzed as raw Nm with body mass entered as as covariate.||||0.342
71718108|NCT04683913|142950452|SUPERIORITY|||||||0.844|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Adduction Moment 2 (late stance was analyzed as raw Nm with body mass entered as as covariate.||||0.844
71718109|NCT04683913|142950452|SUPERIORITY|||||||0.774|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee Flexion Moments were analyzed as raw Nm with body mass entered as as covariate||||0.774
71718110|NCT04683913|142950453|SUPERIORITY|||||||0.186|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee adduction moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.186
71718111|NCT04683913|142950453|SUPERIORITY|||||||0.601|||||||ANCOVA|Controlling for body mass, structural severity and sex. alpha=0.05||Knee flexion moment impulses were analyzed as raw Nm\*s with body mass entered as as covariate.||||0.601
71718112|NCT04552041|142950496|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||<0.0001
71718113|NCT04552041|142950497|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 24 weeks row.||||0.0028
71718114|NCT04552041|142950497|SUPERIORITY|||||||0.1739|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Delusional ideas ∆ between baseline and 24 weeks row."||||0.1739
71718115|NCT04552041|142950497|SUPERIORITY|||||||0.0559|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Hallucinations ∆ between baseline and 24 weeks row."||||0.0559
71718116|NCT04552041|142950497|SUPERIORITY|||||||0.0174|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Agitation ∆ between baseline and 24 weeks row."||||0.0174
71718117|NCT04552041|142950497|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aggression ∆ between baseline and 24 weeks row."||||0.3330
71718118|NCT04552041|142950497|SUPERIORITY|||||||0.1037|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Dysphoria ∆ between baseline and 24 weeks row."||||0.1037
71718119|NCT04552041|142950497|SUPERIORITY|||||||0.0329|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Anxiety ∆ between baseline and 24 weeks row."||||0.0329
71718120|NCT04552041|142950497|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Euphoria ∆ between baseline and 24 weeks row."||||0.2700
71718121|NCT04552041|142950497|SUPERIORITY|||||||0.0557|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Apathy ∆ between baseline and 24 weeks row."||||0.0557
71718122|NCT04552041|142950497|SUPERIORITY|||||||0.982|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Disinhibition ∆ between baseline and 24 weeks row."||||0.9820
71718123|NCT04552041|142950497|SUPERIORITY|||||||0.4626|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Irritability ∆ between baseline and 24 weeks row."||||0.4626
71718124|NCT04552041|142950497|SUPERIORITY|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant motor behaviour ∆ between baseline and 24 weeks row."||||0.0006
71718125|NCT04552041|142950497|SUPERIORITY|||||||0.3725|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Sleep disorders ∆ between baseline and 24 weeks row."||||0.3725
71718126|NCT04552041|142950497|SUPERIORITY|||||||0.1013|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Appetite disorders ∆ between baseline and 24 weeks row."||||0.1013
71718127|NCT04552041|142950497|SUPERIORITY|||||||0.0432|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to domain Aberrant vocalizations ∆ between baseline and 24 weeks row."||||0.0432
71718128|NCT04552041|142950498|SUPERIORITY|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.0316
71718129|NCT04552041|142950499|SUPERIORITY|||||||0.1483|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 12 weeks row.||||0.1483
71718130|NCT04552041|142950500|SUPERIORITY|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0018
71718131|NCT04552041|142950500|SUPERIORITY|||||||0.4733|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.4733
71718132|NCT04552041|142950500|SUPERIORITY|||||||0.0035|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0035
71718133|NCT00661830|142950501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.281|||||TWO_SIDED|95.0|0.811|2.023|||Regression, Cox|||||2.023|0.811|
71718134|NCT00661830|142950502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.747|1.927|||Regression, Cox|||||1.927|0.747|
71718135|NCT01669902|142950526|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 3||||<0.0001
71718136|NCT01669902|142950526|SUPERIORITY_OR_OTHER|||||||0.0357|TWO_SIDED||||||Wilcoxon signed rank test|||Change at Month 6||||0.0357
71718137|NCT01047189|142950536|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Kruskal-Wallis|||||||0.05
71718138|NCT01187095|142950537|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Estimation parameter|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71718139|NCT01187095|142950537|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
71718140|NCT04343092|142950548|SUPERIORITY||Mean Difference (Final Values)|7.92||||0.05|TWO_SIDED||||||t-test, 2 sided||||Historical control population included: Hydroxychloroquin (HCQ) 400mg BID at admission day then 200mg BID for 5 days plus Azithromycin (AZT) 500mg at admission day then 250mg for 5 days.|||0.05
71718141|NCT01639469|142950564|SUPERIORITY||Incidence Rate Ratio|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.68|||Negative Binomial Regression|||Testing to see if there is a significant difference in fall rates over 12months between the two groups.||0.68|0.22|<0.001
71718142|NCT03856359|142950592|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
71718143|NCT03856359|142950594|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71718144|NCT03856359|142950596|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71768399|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.58||0.316|TWO_SIDED|95.0|-1.723|0.558||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.558|-1.723|0.316
71718145|NCT03856359|142950598|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71718146|NCT03856359|142950599|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71718147|NCT03856359|142950600|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71768400|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|4.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768401|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.567||0.336|TWO_SIDED|95.0|-1.66|0.569||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.569|-1.660|0.336
71768402|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.14|STANDARD_DEVIATION|3.9|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768403|NCT02880956|143037289|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.587||0.403|TWO_SIDED|95.0|-1.647|0.663||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.663|-1.647|0.403
71768404|NCT02880956|143037289|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|3.92|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768405|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.4||0.861|TWO_SIDED|95.0|-0.856|0.716||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.716|-0.856|0.861
71768406|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|3.51|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768407|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.13|STANDARD_ERROR_OF_MEAN|0.395||0.746|TWO_SIDED|95.0|-0.648|0.905||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.905|-0.648|0.746
71768408|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.46|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829138|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.67||||0.0465|TWO_SIDED|95.0|-1.33|-0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4||-0.01|-1.33|0.0465
71829139|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.32||||0.3399|TWO_SIDED|95.0|-0.99|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||0.34|-0.99|0.3399
71718148|NCT03856359|142950601|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71718149|NCT03856359|142950602|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71718150|NCT03856359|142950603|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71718151|NCT03856359|142950604|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
71718152|NCT03856359|142950605|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
71718153|NCT03856359|142950606|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71718154|NCT03856359|142950607|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
71718155|NCT03856359|142950608|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71718156|NCT03856359|142950609|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71718157|NCT03856359|142950610|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71718158|NCT00589797|142950628|NON_INFERIORITY|The trial was designed as a non-inferiority trial with a margin (delta) of 15%. Additional analyses using a delta of 10% as requested by FDA were also conducted.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 1 sided|||||||<0.05
71718159|NCT01881009|142950637|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71718160|NCT01881009|142950638|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71718161|NCT02141672|142950640|SUPERIORITY||Odds Ratio (OR)|2.03||||0.045|TWO_SIDED|95.0|1.01|4.05|||Regression, Logistic|||Voclosporin low dose vs. placebo||4.05|1.01|0.045
71768409|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.405||0.859|TWO_SIDED|95.0|-0.724|0.868||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.868|-0.724|0.859
71768410|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|3.64|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768411|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|0.467||0.24|TWO_SIDED|95.0|-0.369|1.469||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.469|-0.369|0.240
71768412|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.16|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768413|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.91|STANDARD_ERROR_OF_MEAN|0.454||0.044|TWO_SIDED|95.0|0.023|1.087||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.087|0.023|0.044
71768414|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.26|STANDARD_DEVIATION|3.51|||TWO_SIDED|||||||||Week 48||||
71718162|NCT02141672|142950640|SUPERIORITY||Odds Ratio (OR)|1.59||||0.204|TWO_SIDED|95.0|0.78|3.27|||Regression, Logistic|||Voclosporin high dose vs. placebo||3.27|0.78|0.204
71718163|NCT02141672|142950641|SUPERIORITY||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|1.68|6.13|||Regression, Logistic|||Voclosporin low dose vs. placebo||6.13|1.68|<0.001
71718164|NCT02141672|142950641|SUPERIORITY||Odds Ratio (OR)|2.1||||0.026|TWO_SIDED|95.0|1.09|4.02|||Regression, Logistic|||Voclosporin high dose vs. placebo||4.02|1.09|0.026
71718165|NCT02141672|142950642|SUPERIORITY||Odds Ratio (OR)|1.9||||0.066|TWO_SIDED|95.0|0.96|3.78|||Regression, Logistic|||||3.78|0.96|0.066
71718166|NCT02141672|142950642|SUPERIORITY||Odds Ratio (OR)|1.64||||0.162|TWO_SIDED|95.0|0.82|3.28|||Regression, Logistic|||||3.28|0.82|0.162
71718167|NCT02141672|142950643|SUPERIORITY||Hazard Ratio (HR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51|||Regression, Cox|||Voclosporin low dose vs. placebo||3.51|1.45|<0.001
71718168|NCT02141672|142950643|SUPERIORITY||Hazard Ratio (HR)|2.25|||<|0.001|TWO_SIDED|95.0|1.46|3.47|||Regression, Cox|||Voclosporin high dose vs. placebo||3.47|1.46|<0.001
71718169|NCT02141672|142950644|SUPERIORITY||Hazard Ratio (HR)|2.89|||<|0.001|TWO_SIDED|95.0|1.58|5.29|||Regression, Cox|||||5.29|1.58|<0.001
71768415|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.61|STANDARD_ERROR_OF_MEAN|0.467||0.195|TWO_SIDED|95.0|-0.312|1.524||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||1.524|-0.312|0.195
71768416|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.17|STANDARD_DEVIATION|3.53|||TWO_SIDED|||||||||Week 48||||
71656994|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|674.06||||0.3249|TWO_SIDED|95.0|-692.21|2040.33||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2040.33|-692.21|0.3249
71718170|NCT02141672|142950644|SUPERIORITY||Hazard Ratio (HR)|1.48|||<|0.248|TWO_SIDED|95.0|0.77|2.86|||Regression, Cox|||Voclosporin high dose vs. placebo||2.86|0.77|<0.248
71718171|NCT02141672|142950646|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.005|TWO_SIDED|95.0|1.16|2.27|||Regression, Cox|||||2.27|1.16|0.005
71718172|NCT02141672|142950646|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.002|TWO_SIDED|95.0|1.25|2.43|||Regression, Cox|||Voclosporin high dose vs. placebo||2.43|1.25|0.002
71718173|NCT02141672|142950648|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.45|2.15|||Regression, Cox|||Voclosporin low dose vs. placebo||2.15|0.45|0.980
71718174|NCT02141672|142950648|SUPERIORITY||Hazard Ratio (HR)|1.98||||0.118|TWO_SIDED|95.0|0.95|4.16|||Regression, Cox|||Voclosporin high dose vs. placebo||4.16|0.95|0.118
71718175|NCT02141672|142950650|SUPERIORITY||Odds Ratio (OR)|2.33||||0.007|TWO_SIDED|95.0|1.26|4.33|||Regression, Logistic|||week 24||4.33|1.26|0.007
71718176|NCT02141672|142950650|SUPERIORITY||Odds Ratio (OR)|2.03||||0.024|TWO_SIDED|95.0|1.1|3.76|||Regression, Logistic|||week 24||3.76|1.1|0.024
71718177|NCT02141672|142950650|SUPERIORITY||Odds Ratio (OR)|2.34||||0.007|TWO_SIDED|95.0|1.27|4.33|||Regression, Logistic|||week 48||4.33|1.27|0.007
71718178|NCT02141672|142950650|SUPERIORITY||Odds Ratio (OR)|2.68||||0.002|TWO_SIDED|95.0|1.43|5.02|||Regression, Logistic|||week 48||5.02|1.43|0.002
71718179|NCT02141672|142950651|SUPERIORITY||Hazard Ratio (HR)|2.03|||<|0.001|TWO_SIDED|95.0|1.36|3.03|||Regression, Cox|||Voclosporin low dose vs. placebo||3.03|1.36|<0.001
71718180|NCT02141672|142950651|SUPERIORITY||Hazard Ratio (HR)|1.81||||0.004|TWO_SIDED|95.0|1.22|2.69|||Regression, Cox|||Voclosporin high dose vs. placebo||2.69|1.22|0.004
71718181|NCT02141672|142950653|SUPERIORITY||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.45|3.36|||Regression, Cox|||Voclosporin low dose vs. placebo||3.36|1.45|<0.001
71718182|NCT02141672|142950653|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.004|TWO_SIDED|95.0|1.23|2.84|||Regression, Cox|||Voclosporin high dose vs. placebo||2.84|1.23|0.004
71718183|NCT01061385|142950672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.2922|TWO_SIDED|95.0|-6.8|21.7|||t-test, 1 sided|||||21.7|-6.8|0.2922
71718184|NCT01061385|142950673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|||||TWO_SIDED|95.0|-37.7|38.0|||||The 95% CI range above is calculated for the current estimated value.|||38.0|-37.7|
71718185|NCT00533429|142950674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.469||||||P-value (one-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.469
71718186|NCT00533429|142950675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.462||||||95% confidence interval based on normal approximation to the binomial distribution. P-value (2-tailed) calculation based on unadjusted, normal-distribution approximation for the difference in rates.|Fisher Exact|||||||0.462
71718187|NCT00533429|142950676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||||||P-value (two-tailed) was calculated based on the un-stratified log-rank test.|Log Rank|||||||0.492
71718188|NCT02967679|142950708|OTHER||Mean Difference (Net)|1.67|STANDARD_DEVIATION|11.45||0.7615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7615
71718189|NCT02967679|142950709|OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|8.89||0.5995|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5995
71718190|NCT02967679|142950710|OTHER||Mean Difference (Net)|4.8|STANDARD_DEVIATION|8.4||0.1641|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1641
71718191|NCT02967679|142950711|OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|16.5||0.0353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0353
71768417|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|0.547||0.778|TWO_SIDED|95.0|-0.921|1.229||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.229|-0.921|0.778
71768418|NCT02880956|143037290|OTHER||Effect size/pooled SD|0.04|STANDARD_DEVIATION|3.99|||TWO_SIDED|||||||||Week 72||||
71718192|NCT02967679|142950712|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.4||0.2642|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2642
71718193|NCT02967679|142950713|OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.2||0.1777|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1777
71718194|NCT02967679|142950714|OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|8.2||0.0371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0371
71718195|NCT02967679|142950715|OTHER||Mean Difference (Net)|-2.2|STANDARD_DEVIATION|2.9||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0142
71718196|NCT02967679|142950717|OTHER||Mean Difference (Net)|0.111|STANDARD_DEVIATION|0.201||0.1055|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1055
71718197|NCT02967679|142950718|OTHER||Mean Difference (Net)|9.84|STANDARD_DEVIATION|28.16||0.213|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2130
71718198|NCT02967679|142950719|OTHER||Mean Difference (Net)|0.068|STANDARD_DEVIATION|0.112||0.0393|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0393
71718199|NCT02967679|142950720|OTHER||Mean Difference (Net)|-5.905|STANDARD_DEVIATION|6.283||0.0004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0004
71718200|NCT02967679|142950721|OTHER||Mean Difference (Net)|-4.28|STANDARD_DEVIATION|32.21||0.3303|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3303
71718201|NCT02967679|142950722|OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.092||0.9229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9229
71718202|NCT00600067|142950732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.17||0.0381|TWO_SIDED|95.0|-0.69|-0.02|||ANCOVA|||||-0.02|-0.69|0.0381
71718203|NCT00600067|142950733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-9.18|-4.21|||ANCOVA|||||-4.21|-9.18|<0.0001
71768419|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.32|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|-0.743|1.376||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.376|-0.743|0.558
71718204|NCT00251693|142950751|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.33||||0.004||95.0|2.17|10.48||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.48|2.17|0.004
71718205|NCT00251693|142950751|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.84||||0.001||95.0|2.7|10.98||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel|||||10.98|2.70|0.001
71829140|NCT00880048|143162932|SUPERIORITY||Mean Difference (Net)|-0.18||||0.5931|TWO_SIDED|95.0|-0.86|0.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.49|-0.86|0.5931
71718206|NCT00251693|142950751|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.727
71718207|NCT00251693|142950752|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.002
71718208|NCT00251693|142950752|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.045
71718209|NCT00251693|142950752|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.245
71718210|NCT00251693|142950753|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.011
71718211|NCT00251693|142950753|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.017
71718212|NCT00251693|142950753|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.927
71718213|NCT00251693|142950754|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.2||||0.06||95.0|2.3|10.11||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.11|2.30|0.060
71718214|NCT00251693|142950754|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.08||||0.029||95.0|2.16|10.0||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank|||||10.00|2.16|0.029
71718215|NCT00251693|142950754|SUPERIORITY_OR_OTHER|||||||0.707||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.707
71768420|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|3.89|||TWO_SIDED|||||||||Week 72||||
71829141|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0562|TWO_SIDED|95.0|0.97|8.22|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1||8.22|0.97|0.0562
71718216|NCT00251693|142950755|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.705
71718217|NCT00251693|142950755|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel|||||||0.146
71718218|NCT00251693|142950755|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.283
71718219|NCT00251693|142950756|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.896
71718220|NCT00251693|142950756|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank|||||||0.241
71718221|NCT00251693|142950756|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank|||||||0.211
71718222|NCT02030821|142950771|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71718223|NCT02030821|142950772|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71718224|NCT02030821|142950773|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71718225|NCT02030821|142950774|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71718226|NCT03192137|142950776|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.||||||0.0005||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with anterior chamber cells Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||0.0005
71718227|NCT03192137|142950777|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.217|||<|0.0001|TWO_SIDED|95.0|1.823|5.675||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||5.675|1.823|<0.0001
71718228|NCT03192137|142950777|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.337|||<|0.0001|TWO_SIDED|95.0|2.305|8.161||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||8.161|2.305|<0.0001
71768421|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.05|STANDARD_ERROR_OF_MEAN|0.546||0.928|TWO_SIDED|95.0|-1.025|1.124||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.124|-1.025|0.928
71718229|NCT03192137|142950777|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.113|8.033||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||8.033|2.113|<0.0001
71718230|NCT03192137|142950777|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.58||||0.0043|TWO_SIDED|95.0|1.38|4.822||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||4.822|1.380|0.0043
71768422|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|4.27|||TWO_SIDED|||||||||Week 72||||
71768423|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.64|STANDARD_ERROR_OF_MEAN|0.541||0.238|TWO_SIDED|95.0|-0.425|1.704||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.704|-0.425|0.238
71768424|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.18|STANDARD_DEVIATION|3.61|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768425|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.53||0.107|TWO_SIDED|95.0|-0.186|1.898||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.898|-0.186|0.107
71829142|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1596|TWO_SIDED|95.0|0.73|6.73|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1||6.73|0.73|0.1596
71768426|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.25|STANDARD_DEVIATION|3.41|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829143|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0067|TWO_SIDED|95.0|1.34|6.3|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2||6.30|1.34|0.0067
71829144|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1154|TWO_SIDED|95.0|0.85|4.36|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2||4.36|0.85|0.1154
71829145|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|1.13||||0.6895|TWO_SIDED|95.0|0.62|2.07|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4||2.07|0.62|0.6895
71829146|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3654|TWO_SIDED|95.0|0.72|2.41|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4||2.41|0.72|0.3654
71718231|NCT03192137|142950777|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.277||||0.0005|TWO_SIDED|95.0|1.695|6.335||P-values were from a Chi-Square test (with continuity correction).|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||6.335|1.695|0.0005
71718232|NCT02737501|142950819|SUPERIORITY||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.35|0.66||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of intracranial central nervous system (iCNS) metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with randomization stratification factors (current) as covariates.|||0.66|0.35|<0.0001
71718233|NCT02737501|142950820|SUPERIORITY||Odds Ratio (OR)|1.74||||0.033|TWO_SIDED|95.0|1.04|2.91|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of intracranial central nervous system (iCNS) metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||2.91|1.04|0.0330
71718234|NCT02737501|142950821|SUPERIORITY||Odds Ratio (OR)|13.56|||<|0.0001|TWO_SIDED|95.0|4.7|39.11|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of prior chemotherapy for Locally advanced or metastatic disease at study entry (current strata).|||39.11|4.70|<0.0001
71718235|NCT02737501|142950822|SUPERIORITY||Hazard Ratio (HR)|0.293|||<|0.0001|TWO_SIDED|95.0|0.17|0.51||P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).|Log Rank||The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.|||0.51|0.17|<0.0001
71768427|NCT02880956|143037290|SUPERIORITY||LS Mean of Difference|0.86|STANDARD_ERROR_OF_MEAN|0.548||0.116|TWO_SIDED|95.0|-0.214|1.942||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.942|-0.214|0.116
71768428|NCT02880956|143037290|SUPERIORITY||Effect size/pooled SD|0.23|STANDARD_DEVIATION|3.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768429|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.186||0.683|TWO_SIDED|95.0|-0.442|0.29||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.290|-0.442|0.683
71768430|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|1.98|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829147|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|1.44||||0.2408|TWO_SIDED|95.0|0.78|2.65|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6||2.65|0.78|0.2408
71829148|NCT00880048|143162933|SUPERIORITY||Odds Ratio (OR)|1.39||||0.3066|TWO_SIDED|95.0|0.74|2.6|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6||2.60|0.74|0.3066
71829149|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1472|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1||0.05|-0.36|0.1472
71829150|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0107|TWO_SIDED|95.0|-0.48|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1||-0.06|-0.48|0.0107
71829151|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0603|TWO_SIDED|95.0|-0.51|0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2||0.01|-0.51|0.0603
71829152|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.2||||0.1458|TWO_SIDED|95.0|-0.46|0.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2||0.07|-0.46|0.1458
71829153|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0941|TWO_SIDED|95.0|-0.58|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4||0.05|-0.58|0.0941
71829154|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.27||||0.088|TWO_SIDED|95.0|-0.59|0.04|||Mixed Models Repeated Measures||Placebo vs GW823296 60mg: Week 4|||0.04|-0.59|0.0880
71829155|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.38||||0.0313|TWO_SIDED|95.0|-0.73|-0.03|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6||-0.03|-0.73|0.0313
71829156|NCT00880048|143162934|SUPERIORITY||Mean Difference (Net)|-0.2||||0.2639|TWO_SIDED|95.0|-0.55|0.15|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6||0.15|-0.55|0.2639
71829157|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-1.57||||0.0421|TWO_SIDED|95.0|-3.08|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.06|-3.08|0.0421
71829158|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-0.74||||0.3394|TWO_SIDED|95.0|-2.27|0.78|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.78|-2.27|0.3394
71829159|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0963|TWO_SIDED|95.0|-3.05|0.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.25|-3.05|0.0963
71829160|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-1.94||||0.0235|TWO_SIDED|95.0|-3.62|-0.26|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||-0.26|-3.62|0.0235
71829161|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-0.77||||0.3956|TWO_SIDED|95.0|-2.54|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||1.01|-2.54|0.3956
71829162|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-0.73||||0.4273|TWO_SIDED|95.0|-2.53|1.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.07|-2.53|0.4273
71829163|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-0.94||||0.3429|TWO_SIDED|95.0|-2.89|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.01|-2.89|0.3429
71718236|NCT02737501|142950826|SUPERIORITY||Odds Ratio (OR)|0.93||||0.822|TWO_SIDED|95.0|0.47|1.82|||Cochran-Mantel-Haenszel||Odds ratios and p-values were from a Cochran-Mantel-Haenszel test stratified by presence of iCNS metastases at Baseline, and prior chemotherapy for locally advanced or metastatic disease (current strata).|||1.82|0.47|0.8220
71718237|NCT02737501|142950828|SUPERIORITY||Least Square Mean Difference|5.79||||0.0295|TWO_SIDED|95.0|0.58|11.0||p-values were obtained using mixed effects models stratified by presence of iCNS metastases at study entry, prior chemotherapy at Baseline.|Mixed Models Analysis|A mixed effect model is used with an unstructured covariance matrix.||||11.00|0.58|0.0295
71718238|NCT00405288|142950919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|STANDARD_DEVIATION|450.0||0.17|TWO_SIDED|95.0|0.0|200.0|||t-test, 2 sided|||"Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.~To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups."||200|0|0.17
71718239|NCT00405288|142950920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.0||0.16|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|0|0.16
71718240|NCT00405288|142950921|SUPERIORITY_OR_OTHER||chi square|30.0||||0.003||95.0|||||McNemar|||The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).||||0.003
71718241|NCT00405288|142950922|SUPERIORITY_OR_OTHER||chi square|5.0||||0.55||95.0|||||McNemar|||The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.||||0.55
71718242|NCT00405288|142950923|SUPERIORITY_OR_OTHER||chi square|10.0||||0.97||95.0|||||McNemar|||Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.||||0.97
71718243|NCT00405288|142950924|SUPERIORITY_OR_OTHER||binary|3.0||||0.31||95.0|||||McNemar|||Low birth weight \<2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.||||0.31
71718244|NCT00405288|142950925|SUPERIORITY_OR_OTHER||chi square|10.0||||0.87||95.0|||||McNemar|||The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.||||0.87
71718245|NCT00405288|142950926|SUPERIORITY_OR_OTHER||proportion|4.0||||0.99||95.0|||||Fisher Exact|||||||0.99
71768431|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.184||0.973|TWO_SIDED|95.0|-0.356|0.368||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.368|-0.356|0.973
71768432|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|1.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829164|NCT00880048|143162935|SUPERIORITY||Mean Difference (Net)|-1.19||||0.2403|TWO_SIDED|95.0|-3.18|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.80|-3.18|0.2403
71829165|NCT00880048|143162936|SUPERIORITY||Mixed effects repeated measures model|22.52||||0.103|TWO_SIDED|95.0|-4.58|49.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, total sleep time||49.61|-4.58|0.1030
71829166|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|33.21||||0.0179|TWO_SIDED|95.0|5.76|60.65|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, total sleep time||60.65|5.76|0.0179
71829167|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|7.62||||0.5773|TWO_SIDED|95.0|-19.25|34.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, total sleep time||34.49|-19.25|0.5773
71887243|NCT04871711|143294889|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.79|-0.4||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|ANCOVA|Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.||Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).||-0.40|-0.79|<0.001
71718246|NCT00405288|142950927|SUPERIORITY_OR_OTHER||proportion|3.0||||0.99||95.0|||||Fisher Exact|||||||0.99
71718247|NCT00405288|142950928|SUPERIORITY_OR_OTHER||proportion|2.0||||0.99||95.0|||||Fisher Exact|||||||0.99
71718248|NCT00405288|142950929|SUPERIORITY_OR_OTHER||proportions|2.0||||0.35||95.0|||||Fisher Exact|||||||0.35
71718249|NCT01646814|142950942|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
71718250|NCT00543985|142950943|SUPERIORITY_OR_OTHER||Pearson correlation coefficient|-0.266|||=|0.14|TWO_SIDED|95.0|||||Regression, Linear|||Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.||||=0.14
71768433|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.189||0.921|TWO_SIDED|95.0|-0.389|0.352||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.352|-0.389|0.921
71829168|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|21.4||||0.125|TWO_SIDED|95.0|-5.97|48.76|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, total sleep time||48.76|-5.97|0.1250
71829169|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|30.87||||0.0344|TWO_SIDED|95.0|2.29|59.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, total sleep time||59.45|2.29|0.0344
71829170|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|36.52||||0.0131|TWO_SIDED|95.0|7.72|65.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, total sleep time||65.32|7.72|0.0131
71718251|NCT04570384|142950954|OTHER||Hazard Ratio (HR)|1.14||||0.782|TWO_SIDED|95.0|0.45|2.86|||Log Rank|||||2.86|0.45|0.782
71718252|NCT04570384|142950954|OTHER||Odds Ratio (OR)|1.25||||0.668|TWO_SIDED|95.0|0.46|3.4|||Regression, Logistic|||||3.40|0.46|0.668
71718253|NCT04570384|142950955|OTHER||Hazard Ratio (HR)|1.58||||0.36|TWO_SIDED|95.0|0.59|4.22|||Log Rank|||||4.22|0.59|0.360
71718254|NCT04570384|142950956|OTHER||Hazard Ratio (HR)|0.49||||0.285|TWO_SIDED|95.0|0.13|1.83|||Log Rank|||||1.83|0.13|0.285
71718255|NCT04570384|142950956|OTHER||Odds Ratio (OR)|0.6||||0.471|TWO_SIDED|95.0|0.15|2.41|||Regression, Logistic|||||2.41|0.15|0.471
71718256|NCT04570384|142950962|OTHER||Odds Ratio, log|0.81||||0.668|TWO_SIDED|95.0|0.3|2.2|||Zero-inflated negative binomial analyses|||||2.20|0.30|0.668
71718257|NCT04570384|142950962|OTHER||Incidence Rate Ratio|0.66||||0.437|TWO_SIDED|95.0|0.23|1.9|||Zero-inflated negative binomial analyses|||||1.90|0.23|0.437
71718258|NCT04570384|142950963|OTHER||Odds Ratio (OR)|0.35||||0.232|TWO_SIDED|95.0|0.06|1.97|||Regression, Logistic|||||1.97|0.06|0.232
71718259|NCT04570384|142950964|OTHER||Odds Ratio (OR)|0.84||||0.729|TWO_SIDED|95.0|0.31|2.28|||Regression, Logistic|||||2.28|0.31|0.729
71718260|NCT04570384|142950965|OTHER||Odds Ratio, log|1.22||||0.706|TWO_SIDED|95.0|0.43|3.44|||Zero-inflated negative binomial analyses|||||3.44|0.43|0.706
71718261|NCT04570384|142950965|OTHER||Incidence Rate Ratio|1.12||||0.788|TWO_SIDED|95.0|0.49|2.56|||Zero-inflated negative binomial analyses|||||2.56|0.49|0.788
71718262|NCT04570384|142950966|OTHER||Incidence Rate Ratio|1.08||||0.834|TWO_SIDED|95.0|0.52|2.25|||Negative binomial analysis|||||2.25|0.52|0.834
71718263|NCT00237042|142950973|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||Regression, Linear|Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.||The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.||||0.19
71718264|NCT00237042|142950974|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.27
71718265|NCT00237042|142950975|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Linear|Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.||The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.||||0.003
71718266|NCT00237042|142950976|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Regression, Logistic|Adjusted for baseline value of the outcome variable||||||0.016
71718267|NCT01897532|142950999|NON_INFERIORITY|The non-inferiority margin was chosen as 1.3 (FDA Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes).|Hazard Ratio (HR)|1.02||||0.0002|TWO_SIDED|95.0|0.89|1.17||p-value for Hazard ratio (HR) ≥1.3 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.0002
71718268|NCT01897532|142950999|OTHER||Hazard Ratio (HR)|1.02||||0.6301|TWO_SIDED|95.0|0.89|1.17||p-value for HR ≥1.0 (1-sided).|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.17|0.89|0.6301
71829171|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|2.18||||0.8794|TWO_SIDED|95.0|-26.1|30.46|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, total sleep time||30.46|-26.10|0.8794
71718269|NCT01897532|142951000|OTHER||Hazard Ratio (HR)|1.04||||0.6918|TWO_SIDED|95.0|0.89|1.22||p-value for HR ≥1.0 (1-sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow's method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.||1.22|0.89|0.6918
71829172|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|28.4||||0.0556|TWO_SIDED|95.0|-0.69|57.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, total sleep time||57.50|-0.69|0.0556
71829173|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-23.9||||0.0078|TWO_SIDED|95.0|-41.46|-6.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep onset latency||-6.33|-41.46|0.0078
71829174|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-25.49||||0.0052|TWO_SIDED|95.0|-43.3|-7.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep onset latency||-7.68|-43.30|0.0052
71829175|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-12.45||||0.2373|TWO_SIDED|95.0|-33.14|8.24|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep onset latency||8.24|-33.14|0.2373
71829176|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|1.75||||0.8707|TWO_SIDED|95.0|-19.38|22.87|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep onset latency||22.87|-19.38|0.8707
71829177|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-12.92||||0.1933|TWO_SIDED|95.0|-32.43|6.59|||Mixed Models Repeated Measures|||Placebo va GW823296 30 mg: Week 4, sleep onset latency||6.59|-32.43|0.1933
71829178|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-10.55||||0.2933|TWO_SIDED|95.0|-30.26|9.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep onset latency||9.17|-30.26|0.2933
71829179|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-28.58||||0.0177|TWO_SIDED|95.0|-52.15|-5.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep onset latency||-5.01|-52.15|0.0177
71718270|NCT00038948|142951003|SUPERIORITY_OR_OTHER||Weighted difference|-2.68||||0.575||95.0|-12.27|6.91||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of 20.0 to 40.0 mL/min||6.91|-12.27|0.575
71829180|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-30.07||||0.0152|TWO_SIDED|95.0|-54.29|-5.84|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep onset latency||-5.84|-54.29|0.0152
71829181|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-17.19||||0.0108|TWO_SIDED|95.0|-30.36|-4.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset||-4.01|-30.36|0.0108
71829182|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-16.15||||0.019|TWO_SIDED|95.0|-29.61|-2.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset||-2.68|-29.61|0.0190
71829183|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|1.89||||0.8195|TWO_SIDED|95.0|-14.43|18.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset||18.21|-14.43|0.8195
71829184|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|5.27||||0.5327|TWO_SIDED|95.0|-11.35|21.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset||21.89|-11.35|0.5327
71829185|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-2.5||||0.7387|TWO_SIDED|95.0|-17.24|12.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset||12.25|-17.24|0.7387
71829186|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-9.44||||0.2134|TWO_SIDED|95.0|-24.35|5.48|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset||5.48|-24.35|0.2134
71829187|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-14.51||||0.1561|TWO_SIDED|95.0|-34.61|5.6|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset||5.60|-34.61|0.1561
71829188|NCT00880048|143162936|SUPERIORITY||Mean Difference (Net)|-17.1||||0.1054|TWO_SIDED|95.0|-37.84|3.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset||3.64|-37.84|0.1054
71829189|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|-0.57||||0.0024|TWO_SIDED|95.0|-0.94|-0.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||-0.21|-0.94|0.0024
71829190|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6146|TWO_SIDED|95.0|-0.47|0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||0.28|-0.47|0.6146
71829191|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|-0.25||||0.1442|TWO_SIDED|95.0|-0.59|0.09|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.09|-0.59|0.1442
71829192|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|0.04||||0.8001|TWO_SIDED|95.0|-0.3|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||0.39|-0.30|0.8001
71829193|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|-0.05||||0.8439|TWO_SIDED|95.0|-0.55|0.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.45|-0.55|0.8439
71887244|NCT04871711|143294890|SUPERIORITY||Risk Difference (RD)|24.5|||<|0.001|TWO_SIDED|95.0|15.0|33.9||Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).|Cochran-Mantel-Haenszel|Stratified by region and baseline IGA-CHE score.|Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.|Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.||33.9|15.0|<0.001
71887245|NCT03551743|143294940|SUPERIORITY||Least Squares Means (Difference)|-65.02||||0.0344|TWO_SIDED||||||ANCOVA|||||||0.0344
71718271|NCT00038948|142951003|SUPERIORITY_OR_OTHER||Weighted difference|1.31||||0.278||95.0|-1.06|3.69||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of \>40.0 mL/min||3.69|-1.06|0.278
71829194|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1259|TWO_SIDED|95.0|-0.91|0.11|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||0.11|-0.91|0.1259
71829195|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|0.2||||0.3709|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||0.64|-0.24|0.3709
71829196|NCT00880048|143162937|SUPERIORITY||Mean Difference (Net)|-0.24||||0.2993|TWO_SIDED|95.0|-0.7|0.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||0.22|-0.70|0.2993
71829197|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.59||||0.0344|TWO_SIDED|95.0|0.04|1.14|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep quality||1.14|0.04|0.0344
71829198|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.72||||0.0111|TWO_SIDED|95.0|0.17|1.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep quality||1.27|0.17|0.0111
71829199|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.42||||0.1443|TWO_SIDED|95.0|-0.15|0.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep quality||0.99|-0.15|0.1443
71829200|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.5||||0.0873|TWO_SIDED|95.0|-0.07|1.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep quality||1.08|-0.07|0.0873
71829201|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.73||||0.017|TWO_SIDED|95.0|0.13|1.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, sleep quality||1.33|0.13|0.0170
71829202|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.42||||0.1675|TWO_SIDED|95.0|-0.18|1.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep quality||1.02|-0.18|0.1675
71829203|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.56||||0.0956|TWO_SIDED|95.0|-0.1|1.23|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep quality||1.23|-0.10|0.0956
71829204|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.32||||0.3503|TWO_SIDED|95.0|-0.35|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep quality||1.00|-0.35|0.3503
71829205|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.34||||0.2147|TWO_SIDED|95.0|-0.2|0.88|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep||0.88|-0.20|0.2147
71829206|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.63||||0.0233|TWO_SIDED|95.0|0.09|1.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep||1.17|0.09|0.0233
71829207|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.33||||0.2404|TWO_SIDED|95.0|-0.22|0.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep||0.89|-0.22|0.2404
71829208|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.65||||0.0247|TWO_SIDED|95.0|0.08|1.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep||1.22|0.08|0.0247
71829209|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.69||||0.0271|TWO_SIDED|95.0|0.08|1.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep||1.29|0.08|0.0271
71829210|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.39||||0.2129|TWO_SIDED|95.0|-0.22|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, refreshing value of sleep||1.00|-0.22|0.2129
71829211|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.37||||0.2874|TWO_SIDED|95.0|-0.31|1.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, refreshing value of sleep||1.06|-0.31|0.2874
71887246|NCT03551743|143294940|SUPERIORITY||Least Squares Means (Difference)|-92.38||||0.0014|TWO_SIDED||||||ANCOVA|||||||0.0014
71718272|NCT00038948|142951004|SUPERIORITY_OR_OTHER|||||||0.135||||||Tests the equality of rates between treatments across strata at 52 weeks.|Cochran-Mantel-Haenszel|||52 weeks statistical analysis across strata||||0.135
71718273|NCT00038948|142951004|SUPERIORITY_OR_OTHER|||||||0.559||||||Tests the equality of rates between treatments across strata at 104 weeks.|Cochran-Mantel-Haenszel|||104 weeks statistical analysis across strata||||0.559
71718274|NCT03682965|142951005|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71718275|NCT03682965|142951006|SUPERIORITY||||||<|0.05||||||The Holm-Bonferroni correction for multiple tests was used because the two outcomes are based on correlated data.|Clopper-Pearson binomial exact test|||The secondary efficacy endpoint was the percentage of days during peak pollen season for which the average total combined score was lower in the immunotherapy group than in the placebo group.||||<0.05
71718276|NCT03682965|142951008|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71718277|NCT04472650|142951043|OTHER||Ratio of Geometric Least Squares Means|87.63|||||TWO_SIDED|90.0|78.273|98.111||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.111|78.273|
71718278|NCT04472650|142951044|OTHER||Ratio of Geometric Least Squares Means|87.5|||||TWO_SIDED|90.0|78.12|98.01||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||98.01|78.12|
71718279|NCT04472650|142951045|OTHER||Ratio of Geometric Least Squares Means|88.8|||||TWO_SIDED|90.0|77.41|101.87||||||Sitravatinib Malate Salt Capsule (Test) vs. Sitravatinib Free Base Capsule (Reference). Analysis based on Relative Bioavailability Analysis Set, defined as the subset of participants in the PK Parameters Analysis Set who had at least 1 primary PK parameter (AUC0-t, AUC0-inf and Cmax of sitravatinib) in both periods.||101.87|77.41|
71718280|NCT00298389|142951052|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71718281|NCT00298389|142951053|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
71718282|NCT00288015|142951054|OTHER|This is a two-stage optimal simon design. If bevacizumab is not effective, there is a 0.050 probability of concluding that it is. If bevacizumab is effective, there is a 0.2000 probability of concluding that it is not.||||||||||||In first stage 12 patients will be entered, if \</=3 patients have PFS time\>3 months p\</=0.22 is likely true. In second stage a total of up to 31 patients data will be analysed. If \>/=10 patients show PFS\</=3 months, it will suggest p\>0.50 is true.|Kaplan-Meier estimate|||This is a two stage optimal simon design testing the Null hypothesis: bevacizumab is not effective with P\<=0.220 and the alternative hypothesis: bevacizumab is effective with P \>=0.450 and has a sample size of 16.96 and a probability of early termination of 0.739. p=probability (progression free survival - PFS time\>/=3 months).|P\<=0.220 is the threshold value of significance that the null hypothesis is true or the alternative hypothesis is true. P Value was not calculated from the data. Median survival time was calculated using a 20% censored Kaplan-Meier table and graph.|||
71718283|NCT00052910|142951091|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.99|||||TWO_SIDED|95.0|0.79|1.24|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.24|0.79|
71718284|NCT00052910|142951092|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.03|||||TWO_SIDED|95.0|0.83|1.28|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV|||1.28|0.83|
71718285|NCT01475721|142951093|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.029||||0.003|TWO_SIDED|95.0|0.638|1.662|||Regression, Cox|||||1.662|0.638|0.003
71718286|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.834||||0.203|TWO_SIDED|95.0|0.63|1.103|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy.|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.103|0.630|0.203
71718287|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.188|TWO_SIDED|95.0|0.645|1.09|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.090|0.645|0.188
71718288|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.002|TWO_SIDED|95.0|0.645|0.905|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.905|0.645|0.002
71718289|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.071|TWO_SIDED|95.0|0.451|1.034|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.034|0.451|0.071
71768434|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|1.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829212|NCT00880048|143162938|SUPERIORITY||Mean Difference (Net)|0.71||||0.0472|TWO_SIDED|95.0|0.01|1.41|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, refreshing value of sleep||1.41|0.01|0.0472
71829213|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9824|TWO_SIDED|95.0|0.13|7.09|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 1||7.09|0.13|0.9824
71829214|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|0.54||||0.6227|TWO_SIDED|95.0|0.05|6.13|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 1||6.13|0.05|0.6227
71829215|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9967|TWO_SIDED|95.0|0.2|5.07|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 2||5.07|0.20|0.9967
71829216|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|2.0||||0.355|TWO_SIDED|95.0|0.46|8.63|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 2||8.63|0.46|0.3550
71829217|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1009|TWO_SIDED|95.0|0.85|6.49|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 4||6.49|0.85|0.1009
71887247|NCT03551743|143294940|SUPERIORITY||Least Squares Means (Difference)|-46.26||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
71887248|NCT03551743|143294941|SUPERIORITY||Least Squares Means (Difference)|88722.37||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
71887249|NCT03551743|143294941|SUPERIORITY||Least Squares Means (Difference)|151500.3||||0.0003|TWO_SIDED||||||ANCOVA|||||||0.0003
71887250|NCT03551743|143294941|SUPERIORITY||Least Squares Means (Difference)|198560.4||||0.0004|TWO_SIDED||||||ANCOVA|||||||0.0004
71887251|NCT03551743|143294942|SUPERIORITY||Least Squares Means (Difference)|-76.05||||0.1874|TWO_SIDED||||||ANCOVA|||||||0.1874
71718290|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.373|TWO_SIDED|95.0|0.659|1.17|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.170|0.659|0.373
71887252|NCT03551743|143294942|SUPERIORITY||Least Squares Means (Difference)|-27.98||||0.386|TWO_SIDED||||||ANCOVA|||||||0.386
71829218|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0455|TWO_SIDED|95.0|1.02|7.68|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 4||7.68|1.02|0.0455
71829219|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0507|TWO_SIDED|95.0|1.0|5.32|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 6||5.32|1.00|0.0507
71718291|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.271|TWO_SIDED|95.0|0.665|1.122|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.122|0.665|0.271
71829220|NCT00880048|143162939|SUPERIORITY||Odds Ratio (OR)|1.38||||0.4962|TWO_SIDED|95.0|0.55|3.45|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 6||3.45|0.55|0.4962
71829221|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|1.03||||0.3241|TWO_SIDED|95.0|-1.03|3.1|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||3.10|-1.03|0.3241
71829222|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|-0.56||||0.602|TWO_SIDED|95.0|-2.66|1.55|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.55|-2.66|0.6020
71829223|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|2.44||||0.0594|TWO_SIDED|95.0|-0.1|4.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||4.99|-0.10|0.0594
71829224|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|0.92||||0.4828|TWO_SIDED|95.0|-1.67|3.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||3.50|-1.67|0.4828
71829225|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|0.19||||0.9008|TWO_SIDED|95.0|-2.8|3.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||3.18|-2.80|0.9008
71829226|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|-0.71||||0.6428|TWO_SIDED|95.0|-3.74|2.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||2.32|-3.74|0.6428
71829227|NCT00880048|143162942|SUPERIORITY||Mean Difference (Net)|-0.68||||0.6911|TWO_SIDED|95.0|-4.06|2.7|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||2.70|-4.06|0.6911
71829228|NCT00880048|143162942|SUPERIORITY||Odds Ratio (OR)|-0.67||||0.7026|TWO_SIDED|95.0|-4.14|2.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.80|-4.14|0.7026
71829229|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|-0.97||||0.1301|TWO_SIDED|95.0|-2.24|0.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1||0.29|-2.24|0.1301
71887253|NCT03551743|143294942|SUPERIORITY||Least Squares Means (Difference)|-49.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71887254|NCT01493180|143294949|SUPERIORITY_OR_OTHER|||||||0.576|||||||t-test, 2 sided|||||||0.576
71887255|NCT03179436|143294961|OTHER||Percent Difference|2.4|||||TWO_SIDED|95.0|-8.7|14.1|||Percent Difference|Comparision based on Miettinen \& Nurminen method||||14.1|-8.7|
71887256|NCT02288273|143294985|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71887257|NCT04247425|143295061|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.59
71887258|NCT04247425|143295062|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.02
71887259|NCT04247425|143295063|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||1.0
71887260|NCT04247425|143295064|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Baseline compared to end of 12 week exercise intervention||||0.09
71887261|NCT02851173|143295084|OTHER|||||||0.79|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group.||||0.79
71887262|NCT02851173|143295084|OTHER|||||||0.87|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. MCI group.||||0.87
71829230|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|0.47||||0.4644|TWO_SIDED|95.0|-0.79|1.73|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1||1.73|-0.79|0.4644
71829231|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|-0.76||||0.3382|TWO_SIDED|95.0|-2.33|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2||0.80|-2.33|0.3382
71829232|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|0.94||||0.241|TWO_SIDED|95.0|-0.63|2.51|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2||2.51|-0.63|0.2410
71829233|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|-0.98||||0.2768|TWO_SIDED|95.0|-2.75|0.79|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4||0.79|-2.75|0.2768
71829234|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|0.06||||0.9434|TWO_SIDED|95.0|-1.7|1.83|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4||1.83|-1.70|0.9434
71829235|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|-0.55||||0.5796|TWO_SIDED|95.0|-2.49|1.4|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6||1.40|-2.49|0.5796
71829236|NCT00880048|143162943|SUPERIORITY||Mean Difference (Net)|0.71||||0.4753|TWO_SIDED|95.0|-1.24|2.66|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6||2.66|-1.24|0.4753
71718292|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.001|TWO_SIDED|95.0|0.637|0.895|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||0.895|0.637|0.001
71829237|NCT04141917|143162944|SUPERIORITY||Risk Ratio, log|1.33|||||TWO_SIDED|95.0|0.35|5.02||||||The number of influenza-positive tests was analyzed using a generalized linear mixed model following a Poisson distribution with a log link and robust variance. The model is adjusted for calendar time and an exposure time variable based on shelter capacity. This model includes symptomatic individuals who tested throughout Year 1 of the study (November 15, 2019 - March 31, 2020).||5.02|0.35|
71829238|NCT00346151|143162959|SUPERIORITY_OR_OTHER||Incidence Rate|60.0||||||95.0|15.0|95.0|||95% exact binomial CI of proportion|||Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.||95|15|
71829239|NCT00346151|143162960|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
71829240|NCT00346151|143162961|SUPERIORITY_OR_OTHER||Incidence rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
71656995|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|677.09||||0.3544|TWO_SIDED|95.0|-784.16|2138.35||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2138.35|-784.16|0.3544
71829241|NCT00346151|143162964|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|40.0|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|40|
71829242|NCT00346151|143162966|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
71829243|NCT00346151|143162967|SUPERIORITY_OR_OTHER||Incidence Rate|80.0||||||95.0|28.0|99.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||99|28|
71829244|NCT00346151|143162968|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
71829245|NCT00346151|143162969|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
71829246|NCT00346151|143162970|SUPERIORITY_OR_OTHER||Incidence Rate|100.0||||||95.0|47.8|100.0|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||100|47.8|
71829247|NCT00346151|143162971|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
71829248|NCT00346151|143162972|SUPERIORITY_OR_OTHER||Incidence Rate|0.0||||||95.0|0.0|52.2|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||52.2|0|
71768435|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.256||0.335|TWO_SIDED|95.0|-0.751|0.257||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.257|-0.751|0.335
71829249|NCT00346151|143162973|SUPERIORITY_OR_OTHER||Incidence Rate|20.0||||||95.0|0.5|71.6|||95% exact binomial CI of proportion|||Proportion with 95% exact binomial confidence interval||71.6|0.5|
71829250|NCT00094575|143162979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.81|TWO_SIDED|95.0|0.77|1.22|||Log Rank||The HR was estimated by comparing Endovascular repair arm vs the Open repair arm.|The primary outcome was long-term, all-cause mortality. The sample size would provide 80% power to detect a 25% relative reduction in mortality at a two-sided alpha level of 0.05. The primary comparison was the main effects of Endovascular repair vs Open repair of AAA.||1.22|0.77|0.81
71829251|NCT00094575|143162980|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
71829252|NCT00094575|143162981|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
71829253|NCT00094575|143162982|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71829254|NCT00094575|143162983|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
71829255|NCT00094575|143162984|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Note: Since this is measuring change over time since baseline, values could be below 0.||||0.58
71829256|NCT00094575|143162985|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
71829257|NCT00094575|143162986|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
71887263|NCT02851173|143295084|OTHER|||||||0.16|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. CU group. 3 outliers removed, whose scores were outside 1.5 times the interquartile range.||||0.16
71887264|NCT02851173|143295085|OTHER|||||||0.22|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 1.||||0.22
71718293|NCT01475721|142951094|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.075|TWO_SIDED|95.0|0.454|1.04|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.||1.040|0.454|0.075
71718294|NCT01475721|142951096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776||||0.123|TWO_SIDED|95.0|0.562|1.071|||Regression, Cox|||||1.071|0.562|0.123
71718295|NCT01475721|142951097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||<|0.001|TWO_SIDED|95.0|-0.385|-0.141|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|||-0.141|-0.385|<0.001
71718296|NCT01475721|142951097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222||||0.003|TWO_SIDED|95.0|-0.369|-0.076|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|||-0.076|-0.369|0.003
71768436|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|-0.11|STANDARD_DEVIATION|2.2|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768437|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|0.11|STANDARD_ERROR_OF_MEAN|0.249||0.67|TWO_SIDED|95.0|-0.383|0.596||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.596|-0.383|0.670
71768438|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|2.01|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768439|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.256||0.95|TWO_SIDED|95.0|-0.486|0.519||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.519|-0.486|0.950
71768440|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|0.01|STANDARD_DEVIATION|2.04|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768441|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.257||0.383|TWO_SIDED|95.0|-0.729|0.281||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.281|-0.729|0.383
71768442|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|-0.1|STANDARD_DEVIATION|2.33|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829258|NCT00762619|143162993|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71656996|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|3.04||||0.9967|TWO_SIDED|95.0|-1469.45|1475.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1475.52|-1469.45|0.9967
71768443|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.254||0.985|TWO_SIDED|95.0|-0.504|0.494||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.494|-0.504|0.985
71768444|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|2.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71829259|NCT00762619|143162994|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718297|NCT01475721|142951097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||<|0.001|TWO_SIDED|95.0|-0.238|-0.106|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|||-0.106|-0.238|<0.001
71718298|NCT01475721|142951097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.251|TWO_SIDED|95.0|-0.216|0.056|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS therapy|||0.056|-0.216|0.251
71718299|NCT00803738|142951098|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary clinical equivalence analysis, a 90% confidence interval was constructed on the difference in the therapeutic cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.3|15.02|||Wald's method with Yates' continuity|||||15.02|-4.30|
71718300|NCT00803738|142951099|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the mycological cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-4.66|11.49|||Wald's method with Yates' continuity|||||11.49|-4.66|
71768445|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.256||0.064|TWO_SIDED|95.0|-0.982|0.027||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.027|-0.982|0.064
71829260|NCT00762619|143162995|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829261|NCT00762619|143162996|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829262|NCT00762619|143162997|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718301|NCT00803738|142951100|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A 90% confidence interval was constructed on the difference in the clinical cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||TWO_SIDED|90.0|-1.35|16.88|||Wald's method with Yates' continuity|||||16.88|-1.35|
71768446|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|2.4|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768447|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|0.28||0.527|TWO_SIDED|95.0|-0.374|0.729||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.729|-0.374|0.527
71768448|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|0.08|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768449|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|0.31|STANDARD_ERROR_OF_MEAN|0.275||0.254|TWO_SIDED|95.0|-0.226|0.854||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.854|-0.226|0.254
71768450|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|0.14|STANDARD_DEVIATION|2.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768451|NCT02880956|143037291|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.284||0.805|TWO_SIDED|95.0|-0.628|0.488||The statistical model: RBANS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.488|-0.628|0.805
71768452|NCT02880956|143037291|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|2.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71718302|NCT00387088|142951108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.085|0.118|||ANCOVA|ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.||||0.118|0.085|<0.0001
71768453|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.361||0.534|TWO_SIDED|95.0|-0.935|0.485||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.485|-0.935|0.534
71768454|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.08|STANDARD_DEVIATION|2.76|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768455|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|0.12|STANDARD_ERROR_OF_MEAN|0.356||0.735|TWO_SIDED|95.0|-0.58|0.821||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.821|-0.580|0.735
71829263|NCT00762619|143162998|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829264|NCT00762619|143162999|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829265|NCT00762619|143163000|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829266|NCT00762619|143163001|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829267|NCT00762619|143163002|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718303|NCT02848092|142951141|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||.76|.52|<.0001
71718304|NCT02848092|142951142|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.29|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 1 month) using a generalized estimating equation.||||-.13|-.29|<.0001
71768456|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|2.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768457|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.365||0.009|TWO_SIDED|95.0|-1.673|-0.24||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||-0.240|-1.673|0.009
71768458|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.35|STANDARD_DEVIATION|2.75|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768459|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.422||0.954|TWO_SIDED|95.0|-0.854|0.806||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.806|-0.854|0.954
71768460|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|2.97|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829268|NCT00762619|143163003|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718305|NCT02848092|142951143|SUPERIORITY||Incidence Risk Ratio|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.76|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||.76|.52|<.0001
71718306|NCT02848092|142951144|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.13|||Generalized Estimating Equation|P value is for the interaction between group (intervention vs. control) and time point (baseline vs. 6 month) using a generalized estimating equation.||||-.13|-.31|<.0001
71718307|NCT02848092|142951145|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.41|0.89||||||||.89|.41|
71768461|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.412||0.649|TWO_SIDED|95.0|-0.622|0.997||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.997|-0.622|0.649
71768462|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|0.06|STANDARD_DEVIATION|2.95|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768463|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.423||0.358|TWO_SIDED|95.0|-1.22|0.443||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.443|-1.220|0.358
71768464|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.13|STANDARD_DEVIATION|2.99|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768465|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.539||0.859|TWO_SIDED|95.0|-1.155|0.963||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.963|-1.155|0.859
71768466|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|3.74|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768467|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.529||0.455|TWO_SIDED|95.0|-0.644|1.437||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||1.437|-0.644|0.455
71718308|NCT02848092|142951146|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.61|0.92||||||||.92|.61|
71718309|NCT00913510|142951148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0||||1||||||The p-value is calculated to the fourth decimal place.|Wilcoxon (Mann-Whitney)|||"H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power."||||1.0000
71768468|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|0.11|STANDARD_DEVIATION|3.6|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768469|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.538||0.335|TWO_SIDED|95.0|-1.578|0.539||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.539|-1.578|0.335
71768470|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|3.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71829269|NCT00762619|143163004|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829270|NCT00762619|143163005|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829271|NCT00762619|143163006|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718310|NCT00512278|142951168|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated||||||0.718|||||||t-test, 2 sided|||||||0.718
71768471|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.681||0.875|TWO_SIDED|95.0|-1.447|1.233||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.233|-1.447|0.875
71768472|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|4.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768473|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|0.25|STANDARD_ERROR_OF_MEAN|0.668||0.712|TWO_SIDED|95.0|-1.068|1.561||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.561|-1.068|0.712
71768474|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|0.05|STANDARD_DEVIATION|4.62|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768475|NCT02880956|143037292|SUPERIORITY||LS Mean of Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.687||0.269|TWO_SIDED|95.0|-2.112|0.59||The statistical model: MMSE change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.590|-2.112|0.269
71829272|NCT00762619|143163007|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718311|NCT00512278|142951170|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.||||||0.718|TWO_SIDED|95.0||||Univariate and multivariable logistic regression were used for factors associated with an SVR.|t-test, 2 sided|||SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of \< 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.||||0.718
71718312|NCT01718522|142951202|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71718313|NCT01718522|142951203|OTHER|||||||0.12|||||||Wilcoxon Signed-Rank Test|||||||0.12
71718314|NCT01718522|142951204|OTHER|||||||0.3|||||||Wilcoxon Signed-Rank Test|||||||0.30
71718315|NCT01718522|142951205|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71718316|NCT01718522|142951206|OTHER|||||||0.04|||||||Wilcoxon Signed-Rank Test|||||||0.04
71718317|NCT01718522|142951207|OTHER|||||||0.35|||||||Wilcoxon Signed-Rank Test|||||||0.35
71718318|NCT01718522|142951208|OTHER|||||||0.001|||||||Wilcoxon Signed-Rank Test|||||||0.001
71718319|NCT01718522|142951209|OTHER|||||||0.61|||||||Wilcoxon Signed-Rank Test|||||||0.61
71718320|NCT01718522|142951210|OTHER|||||||0.1|||||||Wilcoxon Signed-Rank Test|||||||0.1
71718321|NCT01718522|142951211|OTHER|||||||0.22|||||||Wilcoxon Signed-Rank Test|||||||0.22
71718322|NCT01106157|142951218|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.134||0.017|TWO_SIDED|95.0|0.001|0.552|||t-test, 2 sided|||||0.552|0.001|0.017
71718323|NCT01106157|142951219|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.104||0.43|TWO_SIDED|95.0|-0.3|0.13|||t-test, 2 sided|||||0.13|-0.30|0.43
71718324|NCT01106157|142951220|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.7||0.37|TWO_SIDED|95.0|-1.64|0.63|||t-test, 2 sided|||||0.63|-1.64|0.37
71718325|NCT01106157|142951221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED|95.0|-0.4|0.27|||t-test, 2 sided|||||0.27|-0.40|0.69
71718326|NCT01106157|142951222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.75|STANDARD_ERROR_OF_MEAN|81.3||0.89|TWO_SIDED|95.0|-156.8|180.3|||t-test, 2 sided|||||180.3|-156.8|0.89
71718327|NCT01106157|142951223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.15|0.7|||t-test, 2 sided|||||0.70|-0.15|0.2
71718328|NCT01106157|142951224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.13|STANDARD_ERROR_OF_MEAN|19.61||0.23|TWO_SIDED|95.0|-64.8|16.7|||t-test, 2 sided|||||16.7|-64.8|0.23
71718329|NCT01106157|142951225|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037|STANDARD_ERROR_OF_MEAN|0.1||0.79|TWO_SIDED|95.0|-0.18|0.23|||t-test, 2 sided|||||0.23|-0.18|0.79
71718330|NCT01106157|142951226|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|5.33||0.163|TWO_SIDED|95.0|-18.7|3.35|||t-test, 2 sided|||||3.35|-18.7|0.163
71718331|NCT02651116|142951250|SUPERIORITY||Rate Ratio|0.7899|STANDARD_ERROR_OF_MEAN|0.0929||0.0449|TWO_SIDED|95.0|0.6273|0.9947||P-Value less than or equal to (\<=) 0.05 level was considered significantly better and P-Value lying between 0.05 less than (\<) p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per 24 hours for DXM HBr to placebo), and corresponding 95% confidence interval (CI) for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9947|0.6273|0.0449
71718332|NCT02651116|142951250|SUPERIORITY|||||||0.6293||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|Negative Binomial Regression|||P-value was obtained from the negative binomial model with treatment, study site (pooled), age group, log-transformed baseline average cough count per hour (based on Baseline Run-in Period) as factors, with interaction term of treatment by age group, and logarithm of the time over which the cough count was evaluated as the offset parameter.||||0.6293
71718333|NCT02651116|142951251|SUPERIORITY||Rate Ratio|0.8048|STANDARD_ERROR_OF_MEAN|0.0912||0.0552|TWO_SIDED|95.0|0.6446|1.0049||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.0049|0.6446|0.0552
71718334|NCT02651116|142951252|SUPERIORITY||Rate Ratio|0.9551|STANDARD_ERROR_OF_MEAN|0.1491||0.7684|TWO_SIDED|95.0|0.7032|1.2971||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||1.2971|0.7032|0.7684
71768476|NCT02880956|143037292|SUPERIORITY||Effect size/pooled SD|-0.16|STANDARD_DEVIATION|4.78|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829273|NCT00762619|143163008|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829274|NCT00762619|143163009|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829275|NCT00762619|143163010|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829276|NCT00762619|143163011|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71768477|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.785||0.966|TWO_SIDED|95.0|-1.509|1.577||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.577|-1.509|0.966
71768478|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|6.32|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768479|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.775||0.874|TWO_SIDED|95.0|-1.646|1.4||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||1.400|-1.646|0.874
71768480|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|5.89|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768481|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.99|STANDARD_ERROR_OF_MEAN|0.794||0.213|TWO_SIDED|95.0|-0.572|2.551||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||2.551|-0.572|0.213
71768482|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.15|STANDARD_DEVIATION|6.67|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71829277|NCT00762619|143163012|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829278|NCT00762619|143163013|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829279|NCT00762619|143163014|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829280|NCT00762619|143163015|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71887265|NCT02851173|143295085|OTHER|||||||0.69|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left medial frontal/superior frontal gyrus.||||0.69
71887266|NCT02851173|143295085|OTHER|||||||0.25|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior parietal lobule.||||0.25
71887267|NCT02851173|143295085|OTHER|||||||0.86|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left inferior parietal lobule.||||0.86
71887268|NCT02851173|143295085|OTHER|||||||0.28|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Left middle frontal gyrus 2.||||0.28
71887269|NCT02851173|143295085|OTHER|||||||0.12|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right superior frontal gyrus.||||0.12
71887270|NCT02851173|143295085|OTHER|||||||0.26|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. Right middle frontal gyrus.||||0.26
71887271|NCT02851173|143295085|OTHER|||||||0.83|||||||ANOVA|||The contract of interest was the Time x Treatment Group interaction. Right inferior frontal gyrus.||||0.83
71887272|NCT02851173|143295085|OTHER|||||||0.55|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 1.||||0.55
71829281|NCT00762619|143163016|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829282|NCT00762619|143163017|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829283|NCT00762619|143163018|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71887273|NCT02851173|143295085|OTHER|||||||0.76|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left medial frontal/superior frontal gyrus.||||0.76
71768483|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.88|STANDARD_ERROR_OF_MEAN|0.695||0.208|TWO_SIDED|95.0|-0.49|2.242||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.242|-0.490|0.208
71768484|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.17|STANDARD_DEVIATION|5.26|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768485|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|1.03|STANDARD_ERROR_OF_MEAN|0.68||0.131|TWO_SIDED|95.0|-0.307|2.365||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.365|-0.307|0.131
71768486|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.18|STANDARD_DEVIATION|5.57|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829284|NCT00762619|143163019|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829285|NCT00762619|143163020|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829286|NCT00762619|143163021|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829287|NCT00762619|143163022|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829288|NCT00762619|143163023|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718335|NCT02651116|142951253|SUPERIORITY||Rate Ratio|0.7014|STANDARD_ERROR_OF_MEAN|0.1086||0.022|TWO_SIDED|95.0|0.5178|0.95||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9500|0.5178|0.0220
71718336|NCT02651116|142951254|SUPERIORITY||Rate Ratio|0.7454|STANDARD_ERROR_OF_MEAN|0.0848||0.0098|TWO_SIDED|95.0|0.5964|0.9316||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|Negative Binomial Regression|||Estimated rate ratio (ratio of rate of cough counts per specified duration for DXM HBr to placebo, used in evaluation of this outcome measure), and corresponding 95% CI for DXM HBr versus placebo was obtained from negative binomial model with treatment, study site (pooled), age group, and log-transformed baseline average cough count per hour as factors, with logarithm of the time over which the cough count was evaluated as the offset parameter.||0.9316|0.5964|0.0098
71718337|NCT02651116|142951255|SUPERIORITY||Difference in least squares mean|-0.221|STANDARD_ERROR_OF_MEAN|0.1324||0.0977|TWO_SIDED|95.0|-0.4831|0.0411||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANCOVA|||Analysis of covariance (ANCOVA) model contained treatment, study site (pooled), log-transformed baseline cough time and age group terms as factors.||0.0411|-0.4831|0.0977
71718338|NCT02651116|142951256|SUPERIORITY||Difference in least squares mean|-0.2881|STANDARD_ERROR_OF_MEAN|0.1224||0.0191|TWO_SIDED|95.0|-0.5287|-0.0475||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Analysis of variance (ANOVA) model contained treatment, study site (pooled), the corresponding morning baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0475|-0.5287|0.0191
71718339|NCT02651116|142951256|SUPERIORITY|||||||0.8355||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8355
71718340|NCT02651116|142951257|SUPERIORITY||Difference in least squares mean|-0.3128|STANDARD_ERROR_OF_MEAN|0.1104||0.0049|TWO_SIDED|95.0|-0.5299|-0.0956||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0956|-0.5299|0.0049
71768487|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|1.35|STANDARD_ERROR_OF_MEAN|0.695||0.052|TWO_SIDED|95.0|-0.014|2.719||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||2.719|-0.014|0.052
71768488|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|5.55|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768489|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.18|STANDARD_ERROR_OF_MEAN|1.062||0.866|TWO_SIDED|95.0|-1.908|2.268||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.268|-1.908|0.866
71829289|NCT00762619|143163024|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829290|NCT00762619|143163025|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829291|NCT00762619|143163026|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829292|NCT00762619|143163027|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829293|NCT00762619|143163028|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829294|NCT00762619|143163029|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829295|NCT00762619|143163030|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829296|NCT00762619|143163031|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829297|NCT00762619|143163032|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829298|NCT00762619|143163033|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829299|NCT00762619|143163034|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829300|NCT00762619|143163035|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829301|NCT00762619|143163036|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829302|NCT00762619|143163037|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829303|NCT00762619|143163038|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829304|NCT00762619|143163039|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829305|NCT00762619|143163040|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829306|NCT00762619|143163041|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71718341|NCT02651116|142951257|SUPERIORITY|||||||0.8413||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.8413
71718342|NCT02651116|142951258|SUPERIORITY||Difference in least squares mean|-0.1483|STANDARD_ERROR_OF_MEAN|0.1337||0.2679|TWO_SIDED|95.0|-0.4112|0.1146||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding morning baseline impact on sleep by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||0.1146|-0.4112|0.2679
71718343|NCT02651116|142951258|SUPERIORITY|||||||0.2882||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), screening assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2882
71718344|NCT02651116|142951259|SUPERIORITY||Difference in least squares mean|-0.2812|STANDARD_ERROR_OF_MEAN|0.1242||0.0242|TWO_SIDED|95.0|-0.5255|-0.0369||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough frequency by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0369|-0.5255|0.0242
71718345|NCT02651116|142951259|SUPERIORITY|||||||0.2892||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.2892
71718346|NCT02651116|142951260|SUPERIORITY||Difference in least squares mean|-0.3014|STANDARD_ERROR_OF_MEAN|0.1096||0.0063|TWO_SIDED|95.0|-0.517|-0.0858||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model contained treatment, study site (pooled), the corresponding afternoon baseline cough severity by participant, and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0858|-0.5170|0.0063
71768490|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.03|STANDARD_DEVIATION|6.15|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768491|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.46|STANDARD_ERROR_OF_MEAN|1.048||0.66|TWO_SIDED|95.0|-1.599|2.523||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||2.523|-1.599|0.660
71887274|NCT02851173|143295085|OTHER|||||||0.38|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior parietal lobule.||||0.38
71887275|NCT02851173|143295085|OTHER|||||||0.93|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left inferior parietal lobule.||||0.93
71718347|NCT02651116|142951260|SUPERIORITY|||||||0.3268||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model contained treatment, study site (pooled), afternoon baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.3268
71718348|NCT02651116|142951261|SUPERIORITY||Difference in least squares mean|-0.2535|STANDARD_ERROR_OF_MEAN|0.1124||0.0247|TWO_SIDED|95.0|-0.4745|-0.0325||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||ANOVA model with treatment, study site (pooled), the baseline assessment in child global question cold assessment by participant and age group included in the model. The statistical analysis was performed on the composite for all categories.||-0.0325|-0.4745|0.0247
71718349|NCT02651116|142951261|SUPERIORITY|||||||0.4093||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||ANOVA model with treatment, study site (pooled), baseline assessment by participant, interaction of treatment by age group and age group included in the model.||||0.4093
71718350|NCT02651116|142951262|SUPERIORITY||Difference in least squares mean|0.1266|STANDARD_ERROR_OF_MEAN|0.2196||0.5652|TWO_SIDED|95.0|-0.3081|0.5614||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.5614|-0.3081|0.5652
71768492|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|6.94|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768493|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|1.91|STANDARD_ERROR_OF_MEAN|1.062||0.074|TWO_SIDED|95.0|-0.184|3.995||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||3.995|-0.184|0.074
71768494|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.22|STANDARD_DEVIATION|8.65|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768495|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.111||0.747|TWO_SIDED|95.0|-2.545|1.828||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||1.828|-2.545|0.747
71768496|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|0.04|STANDARD_DEVIATION|7.99|||TWO_SIDED|||||||||Week 96||||
71887276|NCT02851173|143295085|OTHER|||||||0.41|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Left middle frontal gyrus 2.||||0.41
71718351|NCT02651116|142951262|SUPERIORITY||Difference in least squares mean|-0.1368|STANDARD_ERROR_OF_MEAN|0.1982||0.4914|TWO_SIDED|95.0|-0.5292|0.2556||P-Value \<=0.05 level was considered significantly better and P-Value lying between 0.05\<p\<=0.1 level was considered marginally significantly better.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), and age group included in the model.||0.2556|-0.5292|0.4914
71718352|NCT02651116|142951262|SUPERIORITY|||||||0.1029||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Participant: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.1029
71718353|NCT02651116|142951262|SUPERIORITY|||||||0.4736||||||P-value is for interaction term of treatment by age group. P-value \<=0.10 was considered significant for interaction terms.|ANOVA|||Caregiver: ANOVA model with treatment, study site (pooled), interaction of treatment by age group and age group included in the model.||||0.4736
71718354|NCT02655887|142951337|NON_INFERIORITY|PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Weighted Z-statistics|88.3||||0.0001|ONE_SIDED|90.0|82.4||||Weighted Z-statistics|||"Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG.~Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG."|||82.4|0.0001
71829307|NCT00762619|143163042|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829308|NCT00762619|143163043|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829309|NCT00762619|143163044|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829310|NCT00762619|143163045|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829311|NCT00762619|143163046|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829312|NCT00762619|143163047|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829313|NCT00762619|143163048|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829314|NCT00762619|143163049|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829315|NCT00762619|143163050|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829316|NCT00762619|143163051|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829317|NCT00762619|143163052|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829318|NCT00762619|143163053|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829319|NCT00762619|143163054|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829320|NCT00762619|143163055|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829321|NCT00762619|143163056|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829322|NCT00762619|143163057|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829323|NCT00762619|143163058|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829324|NCT00762619|143163059|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829325|NCT00762619|143163060|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71829326|NCT00961636|143163061|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test was stratified by country||||||<0.001
71829327|NCT00961636|143163062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Unconditional Miettinen and Nurminen|||||||<0.001
71829328|NCT02023125|143163082|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|270.0|||||TWO_SIDED|90.0|228.0|320.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).||320|228|
71829329|NCT02023125|143163083|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|116.0|||||TWO_SIDED|90.0|103.0|132.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||132|103|
71829330|NCT02023125|143163084|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|292.0|||||TWO_SIDED|90.0|258.0|329.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||329|258|
71718355|NCT02655887|142951338|NON_INFERIORITY|The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%\*99%=84%.|Exact binomial test|93.5||||0.0322|ONE_SIDED|90.0|89.5||||Exact binomial test|||"Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG.~Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG."|||89.5|0.0322
71718356|NCT02655887|142951339|OTHER|||||||0.001||||||this p value is \< 0.001.|t-test, 2 sided|||"H0: The distribution at the 12-month follow-up remains unimproved compared to baseline.~Ha: The distribution shifts toward lower (less pain) classes."||||0.001
71718357|NCT02655887|142951340|OTHER|||||||0.001||||||p value is \< 0.001|t-test, 2 sided|||||||0.001
71718358|NCT00532844|142951385|SUPERIORITY||Geometric Mean Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.2|1.8||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH4 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH4 concentrations when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH4 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.8|1.2|<0.001
71768497|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.15|STANDARD_ERROR_OF_MEAN|1.095||0.891|TWO_SIDED|95.0|-2.004|2.304||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.304|-2.004|0.891
71887277|NCT02851173|143295085|OTHER|||||||0.06|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right superior frontal gyrus.||||0.06
71887278|NCT02851173|143295085|OTHER|||||||0.18|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right middle frontal gyrus.||||0.18
71887279|NCT02851173|143295085|OTHER|||||||0.84|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy). Right inferior frontal gyrus.||||0.84
71718359|NCT00532844|142951386|SUPERIORITY||Geometric Mean Ratio|0.9||||0.139|TWO_SIDED|95.0|0.7|1.0||The model will constitute the independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable plasma BH2 concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in higher plasma BH2 when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the plasma BH2 concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.0|0.7|0.139
71718360|NCT00532844|142951386|SUPERIORITY||Geometric Mean Ratio|0.96||||0.57|TWO_SIDED|95.0|0.83|1.11||The model will constitute independent variables of treatment regimen, treatment sequence, and period as fixed effects, and subject as a random effect. The dependent variable Total B concentration (AUC0-12 hr) expressed in log transformation.|Mixed Models Analysis|||To determine if administration of saproprterin dihydrochloride administered with Vitamin C results in Total B (biopterin) when compared with administration of sapropterin dihydrochloride alone in subjects with endothelial dysfunction. The difference in the Total B (biopterin) concentration (AUC0-12 hr) between the 2 regimens will be compared using a mixed model with a 0.05 level of significance. The difference is represented as the geometric mean ratio.||1.11|0.83|0.570
71718361|NCT00532844|142951389|SUPERIORITY|||||||0.593|||||||ANCOVA|The model will have the treatments and the baseline measurement as independent variables and measurement at Day 13 as the dependent variable.||The raw value of PAT obtained from the first period (baseline to Day 13) will be used to compare the two treatments.||||0.593
71718362|NCT02020590|142951397|OTHER||||||||TWO_SIDED|90.0||||||||"The success of ALLOB® treatment was based on the percentage of responders. A treated patient was considered as responding if, at the end of the study (6 months):~* He/she had not required rescue surgery and~* The GDE score as perceived by the patient had improved by at least 25% or the TUS (tomographic union score) as assessed by CT scan had increased by at least 2 points."|The response rate at Month 6 for the 21 patients in the PP population was 100 % (CI: 86.71 - 100.0%). None of the treated patients required rescue surgery. An improvement of GDE score of at least 25% was reported for 16 (76.2%) patients. An increase in TUS of at least 2 points was reported for 16 (76.2%) patients; all patients met at least one of these two criteria.|||
71718363|NCT04389866|142951398|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_DEVIATION|0.864||0.018|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.018
71768498|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.02|STANDARD_DEVIATION|8.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768499|NCT02880956|143037293|SUPERIORITY||LS Mean of Difference|0.55|STANDARD_ERROR_OF_MEAN|1.12||0.621|TWO_SIDED|95.0|-1.65|2.759||The statistical model: NPI change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||2.759|-1.650|0.621
71887280|NCT02851173|143295086|OTHER|||||||0.53|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.53
71718364|NCT04389866|142951398|SUPERIORITY||Mean Difference (Final Values)|-0.214|STANDARD_DEVIATION|0.864||0.082|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 2 (jawline and lateral zygomatic cheek area injections) analysis of Jawline Rating Scale Assessments given by blinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the blinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.082
71887281|NCT02851173|143295086|OTHER|||||||0.74|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.74
71718365|NCT04389866|142951399|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|0.497||3.1e-07|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for arm 1 (jawline injections) analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.00000031
71718366|NCT04389866|142951399|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.497||7.28e-05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections arm analysis of Jawline Rating Scale Assessments given by unblinded physician.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the unblinded physician Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0000728
71718367|NCT04389866|142951400|SUPERIORITY||Mean Difference (Final Values)|-0.571|STANDARD_DEVIATION|0.611||0.014|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline injections analysis of Jawline Rating Scale Assessments given by subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline injection arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.014
71718368|NCT04389866|142951400|SUPERIORITY||Mean Difference (Final Values)|-0.714|STANDARD_DEVIATION|0.726||0.0065|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|The df = 13 for jawline and lateral (zygomatic) cheek area injections analysis of Jawline Rating Scale Assessments given by the subjects.|Treatment Difference = 4 Weeks after last injection - Baseline|The null hypothesis for the 7 participants placed randomly 1:1 in the jawline and lateral (zygomatic) cheek area injections arm was that there would be no statistically significant change in the subjects' Jawline Rating Scale Assessment at baseline versus four weeks after last injection.||||0.0065
71718369|NCT01490918|142951423|SUPERIORITY|||||||0.0036||||||The threshold for statistical significance was p=0.05|ANCOVA|Baselin HbA1c as covariate||primary outcome efficacy will be evaluated between group 1(placebo + metfromin + sitagliptin) and 2 (sitagliptine + metformin + acarbose)||||0.0036
71768500|NCT02880956|143037293|SUPERIORITY||Effect size/pooled SD|-0.07|STANDARD_DEVIATION|8.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71887282|NCT02851173|143295087|OTHER|||||||0.72|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction.||||0.72
71829331|NCT02023125|143163085|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|109.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|109|
71829332|NCT02023125|143163086|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|377.0|||||TWO_SIDED|90.0|303.0|468.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||468|303|
71887283|NCT02851173|143295087|OTHER|||||||0.97|||||||ANOVA|||The contrast of interest was the Time x Treatment Group interaction. In this sub-group analysis, we performed a sub-population analysis (N=36), including only participants who performed the 2Back task to criterion (\>50% accuracy).||||0.97
71718370|NCT01490918|142951424|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.05|ANCOVA|Baseline HbA1c as covariate||||||<0.0001
71718371|NCT01490918|142951425|SUPERIORITY|||||||0.0185||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline PPG2hr as covariate||||||0.0185
71718372|NCT01490918|142951426|SUPERIORITY|||||||0.0356||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.0356
71718373|NCT01490918|142951427|SUPERIORITY|||||||0.8258||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.8258
71718374|NCT01490918|142951428|SUPERIORITY|||||||0.9217||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.9217
71718375|NCT01490918|142951429|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.16
71718376|NCT01490918|142951430|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.004
71718377|NCT01490918|142951431|SUPERIORITY|||||||0.292||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.292
71768501|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.147|TWO_SIDED|95.0|-0.01|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.064|-0.010|0.147
71887284|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|18.24|||<|0.001|TWO_SIDED|90.0|14.97|21.67||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||21.67|14.97|<.001
71718378|NCT01490918|142951432|SUPERIORITY|||||||0.314||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.314
71718379|NCT01490918|142951433|SUPERIORITY|||||||0.7563||||||The threshold for statistical significance was p=0.05|ANCOVA|baseline data as covariate||||||0.7563
71718380|NCT03141255|142951441|OTHER|||||||1|||||||Fisher Exact|||||||1
71718381|NCT03141255|142951442|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71718382|NCT03141255|142951443|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71718383|NCT03141255|142951444|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71718384|NCT03141255|142951445|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
71718385|NCT03141255|142951446|SUPERIORITY|||||||0.091|||||||Mixed Models Analysis|||||||0.091
71829333|NCT02023125|143163087|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|102.0|||||TWO_SIDED|90.0|87.0|119.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||119|87.0|
71829334|NCT02023125|143163088|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|328.0|||||TWO_SIDED|90.0|276.0|389.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||389|276|
71829335|NCT02023125|143163089|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|110.0|||||TWO_SIDED|90.0|96.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|96.3|
71718386|NCT03141255|142951447|SUPERIORITY|||||||0.029|||||||Mixed Models Analysis|||||||0.029
71718387|NCT03141255|142951448|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71718388|NCT03141255|142951449|SUPERIORITY|||||||0.516|||||||Fisher Exact|||||||0.516
71718389|NCT03141255|142951450|OTHER|||||||0.75|||||||Kaplan Meier|||||||0.75
71718390|NCT03141255|142951451|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71718391|NCT03141255|142951452|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
71718392|NCT01925768|142951471|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.7||||0.004|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||29.3|6.2|0.0040
71718393|NCT01925768|142951472|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.103||||0.1677|TWO_SIDED|95.0|-0.251|0.044|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||0.044|-0.251|0.1677
71718394|NCT01925768|142951473|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.5||||0.004|TWO_SIDED|95.0|6.3|30.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel|Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.|Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||30.6|6.3|0.0040
71718395|NCT01925768|142951474|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.0051|TWO_SIDED|95.0|-0.85|-0.15|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.|||-0.15|-0.85|0.0051
71718396|NCT01925768|142951475|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.68||||0.0167|TWO_SIDED|95.0|0.49|4.88|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||4.88|0.49|0.0167
71718397|NCT01925768|142951476|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4||||0.0039|TWO_SIDED|95.0|1.1|5.7||Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.|Mixed Models Analysis|||2-sided 95% CI for the difference in LS mean.||5.70|1.10|0.0039
71718398|NCT01925768|142951477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0||||0.012|TWO_SIDED|95.0|-21.5|10.2|||Sign test|p-value based on distribution free signed rank test||||10.2|-21.5|0.012
71718399|NCT01925768|142951478|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.7||||0.0016|TWO_SIDED|95.0|8.0|31.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.|||31.3|8.0|0.0016
71718400|NCT01925768|142951479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.0229|TWO_SIDED|95.0|-0.279|-0.021|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.021|-0.279|0.0229
71768502|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.2|STANDARD_DEVIATION|0.14|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71718401|NCT01925768|142951480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.35|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate|||-0.35|-1.00|<0.0001
71718402|NCT01925768|142951481|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.46||||0.0039|TWO_SIDED|95.0|1.13|5.8|||Mixed Models Analysis||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||5.80|1.13|0.0039
71718403|NCT01925768|142951482|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann|10.0||||0.0168|TWO_SIDED|95.0|0.0|20.0|||Stratified Van Elteren test|p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids|Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.|||20.0|0.0|0.0168
71718404|NCT01925768|142951483|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|20.7||||0.0015|TWO_SIDED|95.0|8.5|32.8||2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|||32.8|8.5|0.0015
71718405|NCT01925768|142951484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.7||||0.0252|TWO_SIDED|95.0|1.6|17.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average||17.7|1.6|0.0252
71768503|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.018||0.795|TWO_SIDED|95.0|-0.041|0.031||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.031|-0.041|0.795
71829336|NCT02023125|143163092|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|306.0|||||TWO_SIDED|90.0|269.0|348.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||348|269|
71829337|NCT02023125|143163093|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|122.0|||||TWO_SIDED|90.0|110.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||136|110|
71829338|NCT02023125|143163094|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|349.0|||||TWO_SIDED|90.0|288.0|422.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.||422|288|
71829339|NCT02023125|143163095|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|109.0|||||TWO_SIDED|90.0|95.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.||126|95.3|
71718406|NCT01925768|142951484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.6||||0.1121|TWO_SIDED|95.0|-1.7|18.9||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average||18.9|-1.7|0.1121
71718407|NCT01925768|142951484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.8||||0.0036|TWO_SIDED|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average||29.3|6.2|0.0036
71718408|NCT01925768|142951484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.7||||0.0392|TWO_SIDED|95.0|0.8|24.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average||24.6|0.8|0.0392
71718409|NCT01925768|142951484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.0||||0.0884|TWO_SIDED|95.0|-1.3|23.2||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average||23.2|-1.3|0.0884
71718410|NCT01925768|142951484|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.6||||0.004|TWO_SIDED|95.0|6.5|30.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average||30.7|6.5|0.0040
71718411|NCT04571060|142951509|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.5|13.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.1|4.5|<0.0001
71718412|NCT04571060|142951510|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.7||||0.0012|TWO_SIDED|95.0|3.4|13.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||13.9|3.4|0.0012
71718413|NCT04571060|142951511|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|9.0||||0.0012|TWO_SIDED|95.0|3.6|14.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.5|3.6|0.0012
71718414|NCT04571060|142951512|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2||||0.0001|TWO_SIDED|95.0|5.0|15.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.5|5.0|0.0001
71718415|NCT04571060|142951513|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.6||||0.0048|TWO_SIDED|95.0|2.3|12.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||12.9|2.3|0.0048
71718416|NCT04571060|142951514|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.5||||0.013|TWO_SIDED|95.0|1.4|11.7||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.7|1.4|0.0130
71718417|NCT04571060|142951515|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.9||||0.0076|TWO_SIDED|95.0|1.3|8.5||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||8.5|1.3|0.0076
71718418|NCT04571060|142951516|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|3.7||||0.0308|TWO_SIDED|95.0|0.3|7.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.1|0.3|0.0308
71768504|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|0.12|STANDARD_DEVIATION|0.147|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71887285|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|62.86|||<|0.001|TWO_SIDED|90.0|58.21|67.74||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||67.74|58.21|<.001
71718419|NCT04571060|142951517|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.3||||0.0123|TWO_SIDED|95.0|1.8|14.9||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.9|1.8|0.0123
71718420|NCT04571060|142951518|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|8.6||||0.0018|TWO_SIDED|95.0|3.2|14.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||14.1|3.2|0.0018
71718421|NCT04571060|142951519|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|6.0||||0.0293|TWO_SIDED|95.0|0.6|11.4||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.4|0.6|0.0293
71718422|NCT04571060|142951520|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.7||||0.0362|TWO_SIDED|95.0|0.3|9.1||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||9.1|0.3|0.0362
71718423|NCT04571060|142951521|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|10.2|||<|0.0001|TWO_SIDED|95.0|5.5|15.0||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||15.0|5.5|<0.0001
71718424|NCT04571060|142951522|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|4.4||||0.0059|TWO_SIDED|95.0|1.3|7.6||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||7.6|1.3|0.0059
71718425|NCT04571060|142951523|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at an alpha level of 0.05.|Stratified Percentage Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.2|11.3||Threshold for significance at 0.05.|Cochran-Mantel-Haenszel|||||11.3|4.2|<0.0001
71718426|NCT01361217|142951533|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71718427|NCT01361217|142951533|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71718428|NCT01361217|142951534|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71718429|NCT04970069|142951570|SUPERIORITY||Ratio of geometric means|1.01||||0.89|TWO_SIDED|95.0|0.86|1.18|||Regression, Linear||The numerator and denominator for the ratio of geometric means are analgesic education and general preoperative education respectively.|Multiple imputation by chained equations (MICE) was used for imputing missing outcomes and covariates.||1.18|0.86|0.890
71718430|NCT04970069|142951571|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.617
71718431|NCT04970069|142951572|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.611
71718432|NCT01328743|142951583|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||.04
71768505|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.03|STANDARD_ERROR_OF_MEAN|0.019||0.095|TWO_SIDED|95.0|-0.006|0.069||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 24||0.069|-0.006|0.095
71887286|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|1.11||||0.128|TWO_SIDED|90.0|-0.1|2.33||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||2.33|-0.10|0.128
71887287|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|88.24|||<|0.001|TWO_SIDED|90.0|85.77|90.76||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||90.76|85.77|<.001
71887288|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|44.62|||<|0.001|TWO_SIDED|90.0|34.51|55.23||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||55.23|34.51|<.001
71887289|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|-17.13|||<|0.001|TWO_SIDED|90.0|-21.21|-13.25||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-13.25|-21.21|<.001
71887290|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|70.0|||<|0.001|TWO_SIDED|90.0|58.46|82.2||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||82.20|58.46|<.001
71887291|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|-61.75|||<|0.001|TWO_SIDED|90.0|-68.76|-55.18||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||-55.18|-68.76|<.001
71887292|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|25.38|||<|0.001|TWO_SIDED|90.0|15.37|35.48||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||35.48|15.37|<.001
71887293|NCT01582308|143295099|SUPERIORITY_OR_OTHER||Least squares mean difference|87.13|||<|0.001|TWO_SIDED|90.0|80.06|94.61||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.||94.61|80.06|<.001
71718433|NCT01328743|142951584|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
71718434|NCT01328743|142951585|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
71768506|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.24|STANDARD_DEVIATION|0.13|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 24||||
71768507|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.39|TWO_SIDED|95.0|-0.028|0.072||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.072|-0.028|0.390
71887294|NCT02363478|143295106|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of contractions, resting LES pressure and IRP between baseline and week 4.||||||<0.05
71887295|NCT02363478|143295109|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of heartburn, regurgitation, chest pain and dysphagia between baseline and week 4.||||||0.05
71718435|NCT01328743|142951586|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
71718436|NCT01328743|142951587|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
71718437|NCT01328743|142951588|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71718438|NCT02481258|142951589|EQUIVALENCE|Power calculations were based on a two-sample t-test. A priori calculations to detect an effect size of 0.57 units indicated that that 50 patients per arm were needed to have 80% power. The actual effect size observed in the present study was 0.86.||||||0.05|||||||ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||0.05
71887296|NCT03160560|143295117|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.010
71887297|NCT03160560|143295117|SUPERIORITY|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.932
71887298|NCT03160560|143295117|SUPERIORITY|||||||0.853|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.853
71887299|NCT03160560|143295117|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Baseline-2, Week 6, Week 7, Week 8||||.032
71887300|NCT03160560|143295117|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||<0.001
71887301|NCT03160560|143295117|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline, Week 1, Week 2, Week 3||||.750
71887302|NCT03160560|143295117|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.810
71887303|NCT03160560|143295117|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Baseline 2, Week 6, Week 7, Week 8||||.006
71718439|NCT02481258|142951591|EQUIVALENCE|Power calculations were based on a two-sample t-tests assuming initial recruitment of 50 subjects.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||||||>0.05
71718440|NCT02481258|142951592|EQUIVALENCE|Power calculations were based on a two-sample t-test.|||||>|0.05||||||Our a priori threshold for statistical significance was p \< 0.05.|ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.||||>0.05
71718441|NCT01900665|142951595|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.095|TWO_SIDED|95.0|-1.73|0.14|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||||0.14|-1.73|0.095
71768508|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.12|STANDARD_DEVIATION|0.18|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71768509|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.898|TWO_SIDED|95.0|-0.052|0.045||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.045|-0.052|0.898
71829340|NCT00430300|143163108|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0087||||0.0284|TWO_SIDED|95.0|-0.0943|0.0774|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0774|-0.0943|0.0284
71829341|NCT00430300|143163108|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.0389||||0.0056|TWO_SIDED|95.0|-0.1299|0.0471|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0471|-0.1299|0.0056
71887304|NCT01641939|143295131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.8589|TWO_SIDED|95.0|0.87|1.6||One sided p-value with correction for interim treatment selection due to adaptive seamless phase design.|Log Rank|Log-Rank test, inverse normal combination test.||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||1.60|0.87|0.8589
71887305|NCT01641939|143295132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.32|2.03||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||2.03|0.32|
71887306|NCT01641939|143295132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01|||||TWO_SIDED|95.0|0.82|4.92||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.||4.92|0.82|
71887307|NCT01641939|143295132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.23|0.96||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Trastuzumab Emtansine 3.6 mg||0.96|0.23|
71887308|NCT01641939|143295134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.308|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy||1.43|0.89|0.308
71887309|NCT00847587|143295149|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 8 additional hours was chosen to be clinically relevant, as many common medical interventions (such as epidural anesthesia, cesarean delivery, labor induction, and general stress) have been reported to delay time to lactogenesis stage II by up to 12 hours.|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|120.0|<|0.05|TWO_SIDED|95.0|-10.6|7.7|||t-test, 2 sided|||It was assumed that both groups would have a mean of 54 hours to lactogenesis with a common standard deviation of 12 hours based on previous reports of lactogenesis in women with uncomplicated vaginal deliveries. Setting the noninferiority margin at 8 additional hours, using an alpha 0.05 level comparison, to achieve 80% power a sample size of n=34 evaluable subjects was required in each group. The calculation was performed using N Solution 2007 Professional Software.||7.7|-10.6|<0.05
71718442|NCT04050384|142951625|OTHER||||||<|0.001|||||||ANCOVA|These analyses apply to the Frontal, Central, and Central-Parietal regions.||||||<0.001
71718443|NCT04050384|142951626|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71718444|NCT02383862|142951647|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.79||0.165|TWO_SIDED|95.0|-0.45|2.64|||t-test, 2 sided|||||2.64|-0.45|0.165
71887310|NCT00847587|143295150|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.61|STANDARD_DEVIATION|1.8|<|0.05|TWO_SIDED|95.0|-1.3|2.5|||t-test, 2 sided|||||2.5|-1.3|<0.05
71887311|NCT00454779|143295151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.051|TWO_SIDED|95.0|0.395|1.002|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.002|0.395|0.051
71887312|NCT00454779|143295151|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|Stratified by IVRS randomization factors||||||0.048
71887313|NCT00454779|143295152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.23|||||TWO_SIDED|95.0|-11.67|24.12|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||24.12|-11.67|
71887314|NCT00454779|143295152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||||95.0|0.57|3.33|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||3.33|0.57|
71887315|NCT00454779|143295153|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-8.29|23.85|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS|||23.85|-8.29|
71887316|NCT00454779|143295153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||||95.0|0.62|5.26|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates|||5.26|0.62|
71718445|NCT02383862|142951648|SUPERIORITY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|1.05||0.425|TWO_SIDED|95.0|-1.23|2.91|||t-test, 2 sided|||||2.91|-1.23|0.425
71718446|NCT02383862|142951649|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|1.05||0.539|TWO_SIDED|95.0|-1.41|2.7|||t-test, 2 sided|||||2.70|-1.41|0.539
71718447|NCT02383862|142951650|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|1.16||0.471|TWO_SIDED|95.0|-1.44|3.11|||t-test, 2 sided|||||3.11|-1.44|0.471
71718448|NCT02383862|142951651|SUPERIORITY||Mean Difference (Final Values)|1.49|STANDARD_ERROR_OF_MEAN|1.1||0.174|TWO_SIDED|95.0|-0.66|3.65|||t-test, 2 sided|||||3.65|-0.66|0.174
71718449|NCT02383862|142951652|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|1.36||0.222|TWO_SIDED|95.0|-1.0|4.35|||t-test, 2 sided|||||4.35|-1.00|0.222
71718450|NCT01664247|142951681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34|||<|0.0001|TWO_SIDED|95.0|-2.67|-2.01|||ANOVA||The treatment contrast estimated was IDeg - Placebo.|The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.||-2.01|-2.67|<.0001
71768510|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.19|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 48||||
71829342|NCT00430300|143163108|SUPERIORITY_OR_OTHER||NDLM estimate difference|-0.051||||0.0009|TWO_SIDED|95.0|-0.1298|0.029|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.||0.0290|-0.1298|0.0009
71887317|NCT00454779|143295156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.663|TWO_SIDED|95.0|0.709|1.717|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone|||1.717|0.709|0.663
71718451|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.34|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast.||-2.34|-3.04|<.0001
71718452|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.48|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after breakfast.||-1.48|-2.71|<.0001
71718453|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.56|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before lunch.||-1.56|-2.47|<.0001
71718454|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.4|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after start of lunch.||-1.40|-2.46|<.0001
71718455|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point main evening meal.||-1.23|-2.25|<.0001
71718456|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.26|-1.18|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point 90 mins after main evening meal.||-1.18|-2.26|<.0001
71718457|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.27|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before bedtime.||-1.23|-2.27|<.0001
71718458|NCT01664247|142951682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-2.91|-2.09|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg - Placebo for the time point before breakfast the following day.||-2.09|-2.91|<.0001
71718459|NCT01118780|142951708|SUPERIORITY_OR_OTHER||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|2.47|5.88|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||5.88|2.47|<0.001
71718460|NCT01118780|142951709|SUPERIORITY_OR_OTHER||LS mean difference|3.23|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|1.61|4.85|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||4.85|1.61|<0.001
71829343|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5849|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5849
71829344|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.9737|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.9737
71829345|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.387|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.3870
71829346|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.8612|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.8612
71829347|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.7499|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.7499
71718461|NCT01118780|142951710|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|1.43|3.37||The p-value is for the change from baseline to Week 10 in the HAMA Psychic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.37|1.43|<0.001
71718462|NCT01118780|142951710|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|0.87|2.65||The p-value is for the change from baseline to Week 10 in the HAMA Somatic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.65|0.87|<0.001
71718463|NCT01118780|142951710|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.3|0.74||The p-value is for the change from baseline to Week 10 in the HAMA Anxious Mood Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.74|0.30|<0.001
71718464|NCT01118780|142951710|SUPERIORITY_OR_OTHER||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.11||0.007|TWO_SIDED|95.0|0.09|0.53||The p-value is for the change from baseline to Week 10 in the HAMA Tension Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.53|0.09|0.007
71718465|NCT01118780|142951711|SUPERIORITY_OR_OTHER||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.2|3.18||The p-value is for the change from baseline to Week 10 in the HADS Anxiety Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||3.18|1.20|<0.001
71718466|NCT01118780|142951711|SUPERIORITY_OR_OTHER||LS mean difference|1.69|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.89|2.49||The p-value is for the change from baseline to Week 10 in the HADS Depression Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||2.49|0.89|<0.001
71718467|NCT01118780|142951712|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.26|0.79|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.79|0.26|<0.001
71718468|NCT01118780|142951713|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.33|0.91|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|0.33|<0.001
71718469|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.059|TWO_SIDED|95.0|-0.02|1.11||The p-value is for the change from baseline to Week 10 in BPI-SF Worst Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.11|-0.02|0.059
71718470|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.24||0.079|TWO_SIDED|95.0|-0.05|0.89||The p-value is for the change from baseline to Week 10 in BPI-SF Least Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.89|-0.05|0.079
71718471|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.089|TWO_SIDED|95.0|-0.06|0.91||The p-value is for the change from baseline to Week 10 in BPI-SF Average Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.91|-0.06|0.089
71718472|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.371|TWO_SIDED|95.0|-0.27|0.73||The p-value is for the change from baseline to Week 10 in BPI-SF Pain Right Now Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.73|-0.27|0.371
71718473|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.29||0.066|TWO_SIDED|95.0|-0.04|1.09||The p-value is for the change from baseline to Week 10 in BPI-SF General Activity Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.09|-0.04|0.066
71829348|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5134|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5134
71829349|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.1244|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.1244
71829350|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.53|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.5300
71829351|NCT00430300|143163109|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.055|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0550
71718474|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.41|STANDARD_ERROR_OF_MEAN|0.27||0.14|TWO_SIDED|95.0|-0.13|0.95||The p-value is for the change from baseline to Week 10 in BPI-SF Mood Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.95|-0.13|0.140
71887318|NCT00454779|143295156|SUPERIORITY_OR_OTHER|||||||0.666|||||||Log Rank|Stratified by IVRS randomization factors||||||0.666
71718475|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.04|TWO_SIDED|95.0|0.03|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Walking Ability Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|0.03|0.040
71718476|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.29||0.187|TWO_SIDED|95.0|-0.19|0.94||The p-value is for the change from baseline to Week 10 in BPI-SF Normal Work Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.94|-0.19|0.187
71718477|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.26||0.515|TWO_SIDED|95.0|-0.34|0.68||The p-value is for the change from baseline to Week 10 in BPI-SF Relations With Other People Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||0.68|-0.34|0.515
71718478|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.34||0.141|TWO_SIDED|95.0|-0.17|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Sleep Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.18|-0.17|0.141
71718479|NCT01118780|142951714|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.088|TWO_SIDED|95.0|-0.07|1.07||The p-value is for the change from baseline to Week 10 in BPI-SF Enjoyment of Life Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.07|-0.07|0.088
71718480|NCT01118780|142951715|SUPERIORITY_OR_OTHER||LS mean difference|-5.76|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|-9.4|-2.1|||ANCOVA||LS mean difference was calculated by placebo minus duloxetine. Negative values indicated improvement over placebo.|||-2.1|-9.4|0.002
71718481|NCT01118780|142951717|SUPERIORITY_OR_OTHER||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.43||0.01|TWO_SIDED|95.0|0.27|1.98||The p-value is for the change from baseline to Week 10 in SDS for Work/School Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.98|0.27|0.010
71718482|NCT01118780|142951717|SUPERIORITY_OR_OTHER||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|0.32|1.48||The p-value is for the change from baseline to Week 10 in SDS for Social Life/Leisure Activities Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.48|0.32|0.002
71718483|NCT01118780|142951717|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.61|1.81||The p-value is for the change from baseline to Week 10 in SDS for Family/Home Management Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.|||1.81|0.61|<0.001
71718484|NCT01118780|142951718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having HAMA response at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71718485|NCT01118780|142951718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤7) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71718486|NCT01118780|142951718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for percentage of participants having remission (HAMA Total Score ≤10) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71718487|NCT01118780|142951719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤5) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71718488|NCT01118780|142951719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤6) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||<0.001
71718489|NCT01118780|142951720|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement overall and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.001
71718490|NCT01118780|142951720|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||The p-value is for the percentage of participants having HAMA sustained improvement from Week 2 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel|||||||0.038
71718491|NCT01118780|142951724|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.005
71718492|NCT01118780|142951725|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the time to first remission (HAMA Total Score ≤10) and was adjusted for pooled investigator.|Log Rank|||||||<0.001
71718493|NCT01118780|142951726|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||0.001
71718494|NCT01118780|142951727|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The p-value is for the time to first functional remission (SDS Global Functional Impairment Score ≤5) and was adjusted for pooled investigator.|Log Rank|||||||0.006
71718495|NCT01118780|142951727|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The p-value is for time to first functional remission (SDS Global Functional Impairment Score ≤6) and was adjusted for pooled investigator.|Log Rank|||||||0.003
71718496|NCT01118780|142951728|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was adjusted for pooled investigator.|Log Rank|||||||<0.001
71718497|NCT05018689|142951741|SUPERIORITY||Mean Difference (Net)|0.04||||0.642|TWO_SIDED|95.0|-0.13|0.22|||Regression, Linear|||How confident to identify someone showing depression?||0.22|-0.13|0.642
71887319|NCT05425563|143295170|OTHER||Slope|8.3269|STANDARD_ERROR_OF_MEAN|0.8792|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
71887320|NCT05425563|143295171|OTHER||Slope|8.0809|STANDARD_ERROR_OF_MEAN|0.5414|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
71887321|NCT05425563|143295172|OTHER||Slope|8.121|STANDARD_ERROR_OF_MEAN|0.481|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
71887322|NCT05425563|143295179|OTHER||Slope|34.613|STANDARD_ERROR_OF_MEAN|0.602|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
71887323|NCT05425563|143295180|OTHER||Slope|33.9754|STANDARD_ERROR_OF_MEAN|0.426||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
71887324|NCT05425563|143295181|OTHER||Slope|31.63|STANDARD_ERROR_OF_MEAN|0.422|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||< .001
71887325|NCT01087541|143295195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5|<|0.01||95.0|0.0|1.0|||t-test, 2 sided|||||1|0|<0.01
71887326|NCT01087541|143295197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|5.0|<|0.001|TWO_SIDED|95.0|2.0|15.0|||t-test, 2 sided|||||15|2|<0.001
71718498|NCT05018689|142951741|SUPERIORITY||Mean Difference (Net)|0.02||||0.864|TWO_SIDED|95.0|-0.21|0.25|||Regression, Linear|||How confident to help a friend?||0.25|-0.21|0.864
71718499|NCT05018689|142951742|SUPERIORITY||comparison of odds ratios|0.78||||0.336|TWO_SIDED|95.0|0.47|1.3|||Regression, Logistic|||||1.30|0.47|0.336
71718500|NCT05018689|142951743|SUPERIORITY||comparison of odds ratios|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Regression, Logistic|||Depression runs in families. Answer: true||1.59|0.70|0.806
71768511|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.01|STANDARD_ERROR_OF_MEAN|0.026||0.8|TWO_SIDED|95.0|-0.044|0.057||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 48||0.057|-0.044|0.800
71887327|NCT00168831|143295198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
71887328|NCT00168831|143295198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
71887329|NCT00168831|143295199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.713|STANDARD_ERROR_OF_MEAN|1.052||0.0004||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0004
71887330|NCT00168831|143295199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.445|STANDARD_ERROR_OF_MEAN|1.059||0.0012||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||0.0012
71887331|NCT00168831|143295200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
71887332|NCT00168831|143295200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
71887333|NCT00168831|143295201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg vs. Placebo|||0.890|0.687|0.0002
71887334|NCT00168831|143295201|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg vs. Placebo|||0.828|0.635|<0.0001
71887335|NCT00168831|143295245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71887336|NCT00168831|143295245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|||||ANCOVA||Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71887337|NCT00168831|143295246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71887338|NCT00168831|143295246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71887339|NCT00168831|143295247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71718501|NCT05018689|142951743|SUPERIORITY||comparison of odds ratios|0.96||||0.781|TWO_SIDED|95.0|0.71|1.3|||Regression, Logistic|||Depression can be controlled through willpower. Answer: false||1.30|0.71|0.781
71718502|NCT05018689|142951743|SUPERIORITY||comparison of odds ratios|0.93||||0.72|TWO_SIDED|95.0|0.62|1.39|||Regression, Logistic|||Depression is treatable. Answer: true||1.39|0.62|0.720
71718503|NCT05018689|142951743|SUPERIORITY||comparison of odds ratios|1.11||||0.784|TWO_SIDED|95.0|0.52|2.38|||Regression, Logistic|||Abuse of alcohol and drugs can be a sign of depression. Answer: true||2.38|0.52|0.784
71718504|NCT05018689|142951743|SUPERIORITY||comparison of odds ratios|1.08||||0.662|TWO_SIDED|95.0|0.76|1.55|||Regression, Logistic|||Depression is a sign of personal weakness. Answer: false||1.55|0.76|0.662
71718505|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|0.8||||0.34|TWO_SIDED|95.0|0.51|1.26|||Regression, Logistic|||Difficulty concentrating or making decisions||1.26|0.51|0.340
71718506|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|0.81||||0.265|TWO_SIDED|95.0|0.56|1.17|||Regression, Logistic|||Feeling angry||1.17|0.56|0.265
71718507|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|0.7||||0.259|TWO_SIDED|95.0|0.38|1.3|||Regression, Logistic|||Changes in sleep patterns||1.30|0.38|0.259
71768512|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.04|STANDARD_DEVIATION|0.18|||TWO_SIDED|||||||||Week 48||||
71768513|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.977|TWO_SIDED|95.0|-0.066|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.066|0.977
71887340|NCT00168831|143295247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.393|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71768514|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768515|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.063|0.064||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.064|-0.063|0.990
71768516|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|0.0|STANDARD_DEVIATION|0.24|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768517|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.944|TWO_SIDED|95.0|-0.063|0.067||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 72||0.067|-0.063|0.944
71768518|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.23|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 72||||
71768519|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.0|STANDARD_ERROR_OF_MEAN|0.042||0.942|TWO_SIDED|95.0|-0.079|0.085||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.085|-0.079|0.942
71768520|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.01|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768521|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.041||0.876|TWO_SIDED|95.0|-0.087|0.074||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.074|-0.087|0.876
71768522|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|0.02|STANDARD_DEVIATION|0.27|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71768523|NCT02880956|143037294|SUPERIORITY||LS Mean of Difference|0.06|STANDARD_ERROR_OF_MEAN|0.043||0.163|TWO_SIDED|95.0|-0.024|0.143||The statistical model: ADCOMS change from baseline = baseline + treatment + site + visit + baseline\*visit + treatment\*visit; variance-covariance structure = Unstructured.|repeated measures model|||Week 96||0.143|-0.024|0.163
71768524|NCT02880956|143037294|SUPERIORITY||Effect size/pooled SD|-0.21|STANDARD_DEVIATION|0.28|||TWO_SIDED||||||||Effect size at a specific visit is calculated as LS mean difference (8E12 - placebo) divided by pooled standard deviation of change scores for a ABBV-8E12 dose and placebo at that visit.|Week 96||||
71829352|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.7444|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.7444
71829353|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.9134|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.9134
71768525|NCT00830791|143037327|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.74||||0.325|TWO_SIDED|90.0|0.43|1.26|||ANCOVA||The mean square error on a log scale for this comparison was 0.322.|||1.26|0.43|0.325
71768526|NCT00830791|143037328|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.718|TWO_SIDED|90.0|0.76|1.2|||ANCOVA||The mean square error on a log scale was 0.061 for this comparison.|||1.20|0.76|0.718
71768527|NCT00830791|143037329|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.63||||0.014|TWO_SIDED|90.0|1.21|2.2|||ANCOVA||The mean square error on a log scale was 0.104 for this comparison.|||2.20|1.21|0.014
71768528|NCT00830791|143037331|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14||||0.505|TWO_SIDED|90.0|0.81|1.6|||ANCOVA||The mean square error on a log scale for this comparison was 0.133.|||1.60|0.81|0.505
71768529|NCT00830791|143037333|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
71768530|NCT00830791|143037334|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.0|||||TWO_SIDED|90.0|0.0|0.5|||ANCOVA|||||0.50|0.00|
71768531|NCT01527357|143037348|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
71768532|NCT01527357|143037349|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
71768533|NCT01527357|143037350|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
71768534|NCT01527357|143037351|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||< 0.0001
71768535|NCT02446171|143037356|SUPERIORITY_OR_OTHER||Ratio#|98.89|||||TWO_SIDED|90.0|92.4|105.84|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.84|92.40|
71768536|NCT02446171|143037356|SUPERIORITY_OR_OTHER||Ratio#|100.04|||||TWO_SIDED|90.0|93.17|107.43|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.43|93.17|
71768537|NCT02446171|143037356|SUPERIORITY_OR_OTHER||Ratio#|94.37|||||TWO_SIDED|90.0|88.7|100.4|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.40|88.70|
71768538|NCT02446171|143037357|SUPERIORITY_OR_OTHER||Ratio#|98.79|||||TWO_SIDED|90.0|92.24|105.8|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||105.80|92.24|
71768539|NCT02446171|143037357|SUPERIORITY_OR_OTHER||Ratio#|100.44|||||TWO_SIDED|90.0|93.65|107.72|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||107.72|93.65|
71887341|NCT00168831|143295248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71768540|NCT02446171|143037357|SUPERIORITY_OR_OTHER||Ratio#|94.83|||||TWO_SIDED|90.0|89.2|100.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||100.82|89.20|
71768541|NCT02446171|143037358|SUPERIORITY_OR_OTHER||Ratio#|97.05|||||TWO_SIDED|90.0|88.09|106.92|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||106.92|88.09|
71768542|NCT02446171|143037358|SUPERIORITY_OR_OTHER||Ratio#|100.56|||||TWO_SIDED|90.0|91.8|110.16|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||110.16|91.80|
71768543|NCT02446171|143037358|SUPERIORITY_OR_OTHER||Ratio#|102.5|||||TWO_SIDED|90.0|93.13|111.82|||ANOVA|The results are based on ANOVA of log transformed PK parameters with sequence, period, treatment, and subject nested within sequence as fixed effects.||||111.82|93.13|
71768544|NCT04531462|143037373|SUPERIORITY|Null hypothesis: Mean change from baseline in HbA1c after 52 weeks of treatment with empagliflozin 10 mg = mean change from baseline in HbA1c after 52 weeks of treatment with placebo.|Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.36||Threshold level for statistical significance: α = 0.05 .|Mixed Model Repeated Measures (MMRM)||Empagliflozin 10 mg- Placebo|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) which included fixed classification effects for treatment, gender, baseline renal function, visit and visit-by-treatment interaction, and a linear covariate for baseline HbA1c and age. An unstructured covariance structure was used to model the within patient errors. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.||-0.36|-0.78|<0.0001
71768545|NCT04531462|143037374|OTHER||Mean Difference (Net)|-0.61||||0.231|TWO_SIDED|95.0|-1.61|0.39|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline muscle mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.39|-1.61|0.2310
71829354|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.6841|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6841
71887342|NCT00168831|143295248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71887343|NCT00168831|143295249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71887344|NCT00168831|143295249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.1|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71887345|NCT00168831|143295250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0169||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||0.0169
71768546|NCT04531462|143037375|OTHER||Mean Difference (Net)|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.65|-1.04|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline body fat measurement, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-1.04|-2.65|<0.0001
71768547|NCT04531462|143037376|OTHER||Mean Difference (Net)|-0.53||||0.1632|TWO_SIDED|95.0|-1.28|0.22|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline lean body mass, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.22|-1.28|0.1632
71768548|NCT04531462|143037377|OTHER||Mean Difference (Net)|-0.63||||0.0384|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline total body water, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||-0.03|-1.23|0.0384
71768549|NCT04531462|143037378|OTHER||Mean Difference (Net)|-0.03||||0.1975|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline bone mineral content, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.01|-0.07|0.1975
71768550|NCT04531462|143037379|OTHER||Mean Difference (Net)|-0.081||||0.3725|TWO_SIDED|95.0|-0.259|0.098|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) which included baseline skeletal muscle index, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.098|-0.259|0.3725
71768551|NCT04531462|143037380|OTHER||Mean Difference (Net)|-0.3||||0.4208|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline grip strength, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.5|-1.1|0.4208
71829355|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.9283|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.9283
71829356|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.2991|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.2991
71887346|NCT00168831|143295250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71887347|NCT04652804|143295273|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|1.0|1.19||||||Reference group: Low Intensity Intervention||1.19|1.00|
71887348|NCT04652804|143295273|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.9|1.05||||||Reference Group: Low Intensity Intervention||1.05|0.90|
71887349|NCT04652804|143295273|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.8|1.15||||||Reference group: High Intensity Intervention||1.15|0.80|
71887350|NCT04652804|143295273|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.77|1.04||||||Reference group: High Intensity Intervention||1.04|0.77|
71887351|NCT04428411|143295362|OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
71887352|NCT04428411|143295363|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
71887353|NCT04428411|143295364|OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
71887354|NCT04428411|143295365|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71887355|NCT04428411|143295366|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71768552|NCT04531462|143037381|OTHER||Mean Difference (Net)|0.0||||0.9267|TWO_SIDED|95.0|-1.0|0.9|||ANCOVA||Empagliflozin 10 mg- Placebo|Analysis of Covariance (ANCOVA) included baseline 5-time chair stand test, age, baseline glycated hemoglobin (HbA1c), baseline body mass index (BMI) as linear covariates and sex, treatment as fixed effects.||0.9|-1.0|0.9267
71768553|NCT04175509|143037384|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||.378
71768554|NCT04175509|143037385|SUPERIORITY|||||||0.753|||||||t-test, 2 sided|||||||.753
71768555|NCT04175509|143037386|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
71768556|NCT04175509|143037387|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71768557|NCT04175509|143037388|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
71887356|NCT04428411|143295367|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71887357|NCT04428411|143295368|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
71887358|NCT04428411|143295369|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71887359|NCT04428411|143295370|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71887360|NCT04428411|143295371|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
71887361|NCT04428411|143295371|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
71887362|NCT04428411|143295372|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
71887363|NCT04428411|143295372|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
71887364|NCT04428411|143295373|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 4||||0.0001
71887365|NCT04428411|143295373|OTHER|||||||0.0001|||||||t-test, 2 sided|||Comparison between Baseline and Month 12||||0.0001
71887366|NCT03543410|143295437|SUPERIORITY||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.625||0.044|TWO_SIDED|95.0|-6.489|-0.09||nominal p-value|Mixed Models Analysis|||||-0.090|-6.489|0.044
71887367|NCT03543410|143295437|SUPERIORITY||Mean Difference (Final Values)|-3.128|STANDARD_ERROR_OF_MEAN|1.597||0.051|TWO_SIDED|95.0|-6.273|0.017||nominal p-value|Mixed Models Analysis|||||0.017|-6.273|0.051
71887368|NCT03543410|143295438|SUPERIORITY||Mean Difference (Final Values)|-0.281|STANDARD_ERROR_OF_MEAN|0.191||0.143|TWO_SIDED|95.0|-0.658|0.095||nominal p-value|Mixed Models Analysis|||||0.095|-0.658|0.143
71887369|NCT03543410|143295438|SUPERIORITY||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.187||0.243|TWO_SIDED|95.0|-0.588|0.15||nominal p-value|Mixed Models Analysis|||||0.150|-0.588|0.243
71887370|NCT00535925|143295445|OTHER||Cox Proportional Hazard|0.48|||<|0.05|TWO_SIDED||||||Regression, Cox|Cox Shared Frailty Model, adjusted for age, sex, SBP, Hb, eGFR, albuminuria, HbA1c, total cholesterol, triglycerides (log-scaled) to reduce bias risk.||||||<0.05
71887371|NCT02105415|143295478|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.385|TWO_SIDED|95.0|-6.9|2.7|||ANCOVA|||5 minutes||2.7|-6.9|0.385
71887372|NCT02105415|143295478|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.241|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|||10 minutes||2.8|-10.8|0.241
71887373|NCT02105415|143295478|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.802|TWO_SIDED|95.0|-7.2|5.6|||ANCOVA|||15 minutes||5.6|-7.2|0.802
71887374|NCT02105415|143295479|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
71887375|NCT02105415|143295480|SUPERIORITY|||||||0.212|||||||ANCOVA|||Pre-treatment||||0.212
71887376|NCT02105415|143295480|SUPERIORITY|||||||0.308|||||||ANCOVA|||New-onset pressors (within 3 minutes)||||0.308
71887377|NCT02105415|143295480|SUPERIORITY|||||||0.691|||||||ANCOVA|||Delayed-onset pressors (within 24 hrs)||||0.691
71887378|NCT02105415|143295482|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
71887379|NCT02105415|143295483|SUPERIORITY|||||||0.069|||||||ANCOVA|||Red blood cell||||0.069
71887380|NCT02105415|143295483|SUPERIORITY|||||||0.046|||||||ANCOVA|||Non-red blood cell||||0.046
71887381|NCT02105415|143295483|SUPERIORITY|||||||0.502|||||||ANCOVA|||Colloid||||0.502
71887382|NCT02105415|143295484|SUPERIORITY|||||||0.994|||||||ANCOVA|||||||0.994
71887383|NCT02105415|143295485|SUPERIORITY|||||||0.233|||||||ANCOVA|||||||0.233
71887384|NCT01116544|143295546|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|TWO_SIDED|||||A priori threshold = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.005
71887385|NCT01116544|143295547|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.|||||<|0.001||||||Hypothesis: significant increase in score (post-tx - pre-tx) for both groups|ANCOVA|FMA scores adjusted for baseline differences.||||||<0.001
71887386|NCT01116544|143295548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Across both groups, whether score increased following completion of intervention|ANCOVA|||||||0.001
71887387|NCT01116544|143295549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Across both treatment groups|ANCOVA|||||||0.001
71887388|NCT01116544|143295550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data combined between 2 treatment groups||||0.001
71887389|NCT01116544|143295551|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Both treatment groups combined||||>0.05
71718508|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|1.12||||0.45|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Frequent unexplained aches and pains||1.49|0.84|0.450
71718509|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|2.28||||0.025|TWO_SIDED|95.0|1.11|4.69|||Regression, Logistic|||Feeling tired or less energetic||4.69|1.11|0.025
71718510|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|1.01||||0.937|TWO_SIDED|95.0|0.71|1.44|||Regression, Logistic|||Eating more than usual||1.44|0.71|0.937
71718511|NCT05018689|142951744|SUPERIORITY||comparison of odds ratios|0.83||||0.447|TWO_SIDED|95.0|0.52|1.34|||Regression, Logistic|||Feeling irritable or restless||1.34|0.52|0.447
71718512|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.11|0.14|||Regression, Linear|||Friend||0.14|-0.11|0.800
71718513|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.05||||0.451|TWO_SIDED|95.0|-0.18|0.08|||Regression, Linear|||Parent/guardian||0.08|-0.18|0.451
71768558|NCT04175509|143037389|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
71768559|NCT04175509|143037390|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
71768560|NCT04175509|143037391|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
71829357|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.7403|ONE_SIDED|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.15|0.7403
71718514|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|0.07||||0.335|TWO_SIDED|95.0|-0.07|0.2|||Regression, Linear|||School counselor||0.2|-0.07|0.335
71718515|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.04||||0.554|TWO_SIDED|95.0|-0.17|0.09|||Regression, Linear|||Teacher||0.09|-0.17|0.554
71718516|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.04||||0.541|TWO_SIDED|95.0|-0.19|0.1|||Regression, Linear|||Mental health professional||0.10|-0.19|0.541
71718517|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|0.05||||0.454|TWO_SIDED|95.0|-0.09|0.19|||Regression, Linear|||Doctor||0.19|-0.09|0.454
71718518|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.02||||0.749|TWO_SIDED|95.0|-0.16|0.12|||Regression, Linear|||Internet/website||0.12|-0.16|0.749
71718519|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.13||||0.03|TWO_SIDED|95.0|-0.24|-0.01|||Regression, Linear|||Clergy, priest, rabbi, or other religious person||-0.01|-0.24|0.030
71718520|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|0.06||||0.334|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||Phone helpline||0.18|-0.06|0.334
71718521|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|0.07||||0.243|TWO_SIDED|95.0|-0.05|0.2|||Regression, Linear|||Crisis textline||0.20|-0.05|0.243
71718522|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.05||||0.492|TWO_SIDED|95.0|-0.19|0.09|||Regression, Linear|||Other relative (i.e., sister, brother, aunt, uncle)||0.09|-0.19|0.492
71718523|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Regression, Linear|||Boyfriend or girlfriend||0.10|-0.17|0.610
71718524|NCT05018689|142951745|SUPERIORITY||Mean Difference (Net)|-0.12||||0.061|TWO_SIDED|95.0|-0.25|0.01|||Regression, Linear|||Coach||0.01|-0.25|0.061
71718525|NCT05018689|142951746|SUPERIORITY||comparison of odds ratios|1.27||||0.086|TWO_SIDED|95.0|0.97|1.66|||Regression, Logistic|||If you had depression symptoms for more than 2 weeks, would you ask for help?||1.66|0.97|0.086
71718526|NCT05018689|142951746|SUPERIORITY||comparison of odds ratios|1.13||||0.526|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic|||If you thought you had mental health issues, is there a trusted adult you would go to?||1.66|0.77|0.526
71718527|NCT05018689|142951747|SUPERIORITY||Mean Difference (Net)|0.06||||0.199|TWO_SIDED|95.0|-0.03|0.16|||Regression, Linear|||Do you know how to get help in your school?||0.16|-0.03|0.199
71718528|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||Regression, Linear|||The new student is more dangerous than other students||-0.12|-0.38|<0.001
71718529|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|-0.18||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Regression, Linear|||The student is to blame for his or her condition||-0.06|-0.29|0.003
71718530|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.06|0.18|||Regression, Linear|||I would have sympathy for the new student||0.18|-0.06|0.310
71768561|NCT03811093|143037431|SUPERIORITY||Mean Difference (Net)|2.036|||<|0.01|TWO_SIDED|95.0|1.243|2.828||p-value is calculated using SPSS.|t-test, 2 sided|||The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.||2.828|1.243|<0.01
71768562|NCT03811093|143037431|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218."||||0.20
71829358|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.3499|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.3499
71829359|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.2734|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2734
71829360|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.5806|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.5806
71829361|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.11||0.054|ONE_SIDED|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.00|0.0540
71718531|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|-0.1||||0.114|TWO_SIDED|95.0|-0.21|0.02|||Regression, Linear|||The new student makes me feel scared||0.02|-0.21|0.114
71718532|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|0.02||||0.738|TWO_SIDED|95.0|-0.1|0.15|||Regression, Linear|||The new student makes me feel uncomfortable||0.15|-0.10|0.738
71718533|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|0.12||||0.04|TWO_SIDED|95.0|0.01|0.24|||Regression, Linear|||I would help the new student even if I did not know him or her well||0.24|0.01|0.040
71718534|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|-0.17||||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Regression, Linear|||I would try to stay away from the new student||-0.05|-0.29|0.006
71718535|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|-0.02||||0.798|TWO_SIDED|95.0|-0.15|0.11|||Regression, Linear|||The new student would be made fun of at my school||0.11|-0.15|0.798
71718536|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|-0.09||||0.197|TWO_SIDED|95.0|-0.22|0.05|||Regression, Linear|||The new student would be ignored at my school||0.05|-0.22|0.197
71768563|NCT03811093|143037431|OTHER|||||||0.075|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.075
71768564|NCT03811093|143037432|SUPERIORITY||Mean Difference (Net)|7.063|||<|0.01|TWO_SIDED|95.0|3.829|10.296||p-value is calculated using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.||10.296|3.829|<0.01
71768565|NCT03811093|143037432|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796."||||0.20
71829362|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2616|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.2616
71829363|NCT00430300|143163110|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.0724|ONE_SIDED|95.0|-0.02||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.02|0.0724
71718537|NCT05018689|142951748|SUPERIORITY||Mean Difference (Net)|0.03||||0.623|TWO_SIDED|95.0|-0.1|0.16|||Regression, Linear|||I think other students in my school would try to help the new student||0.16|-0.10|0.623
71718538|NCT05018689|142951749|SUPERIORITY||Mean Difference (Net)|0.05||||0.718|TWO_SIDED|95.0|-0.21|0.3|||Regression, Linear|||On a scale from 1 to 7, if you were seen going into the office of your school social worker or school psychologist, how would you feel?||0.30|-0.21|0.718
71718539|NCT05018689|142951750|SUPERIORITY||Mean Difference (Net)|0.21||||0.09|TWO_SIDED|95.0|-0.03|0.46|||Regression, Linear|||How comfortable are you talking about mental health issues with other students at your school?||0.46|-0.03|0.090
71718540|NCT05018689|142951751|SUPERIORITY||comparison of odds ratios|0.99||||0.944|TWO_SIDED|95.0|0.67|1.44|||Regression, Logistic|||Depression||1.44|0.67|0.944
71718541|NCT05018689|142951751|SUPERIORITY||comparison of odds ratios|1.18||||0.369|TWO_SIDED|95.0|0.82|1.68|||Regression, Logistic|||Anxiety||1.68|0.82|0.369
71718542|NCT05018689|142951751|SUPERIORITY||comparison of odds ratios|1.07||||0.676|TWO_SIDED|95.0|0.77|1.5|||Regression, Logistic|||Thoughts of suicide||1.50|0.77|0.676
71829364|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.1||0.9362|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.9362
71829365|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.9469|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.9469
71829366|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.9153|ONE_SIDED|95.0|-0.27||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.27|0.9153
71829367|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.9686|ONE_SIDED|95.0|-0.36||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.36|0.9686
71829368|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1548|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1548
71829369|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.7973|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.7973
71718543|NCT05018689|142951751|SUPERIORITY||comparison of odds ratios|0.79||||0.432|TWO_SIDED|95.0|0.44|1.42|||Regression, Logistic|||I do not think there are any mental health issues that are concerning for students||1.42|0.44|0.432
71718544|NCT05018689|142951751|SUPERIORITY||comparison of odds ratios|0.87||||0.533|TWO_SIDED|95.0|0.56|1.35|||Regression, Logistic|||Other||1.35|0.56|0.533
71718545|NCT05018689|142951752|SUPERIORITY||Mean Difference (Net)|-0.01||||0.769|TWO_SIDED|95.0|-0.11|0.08|||Regression, Linear|||How much do your teachers know about addressing student mental health needs?||0.08|-0.11|0.769
71718546|NCT05018689|142951752|SUPERIORITY||Mean Difference (Net)|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||Regression, Linear|||How much do your school counselors know about addressing student mental health needs?||0.16|-0.05|0.315
71829370|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.6348|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.6348
71829371|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.5742|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.5742
71829372|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6719|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.6719
71829373|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.13||0.0881|ONE_SIDED|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.04|0.0881
71829374|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.2772|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2772
71829375|NCT00430300|143163111|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.11||0.1363|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1363
71829376|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0938|ONE_SIDED|95.0|-0.03||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.03|0.0938
71829377|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.2149|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.2149
71829378|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.09||0.1682|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1682
71718547|NCT05018689|142951753|SUPERIORITY||comparison of odds ratios|0.86||||0.345|TWO_SIDED|95.0|0.63|1.18|||Regression, Logistic|||Mental health information sheets at school||1.18|0.63|0.345
71718548|NCT05018689|142951753|SUPERIORITY||comparison of odds ratios|0.98||||0.899|TWO_SIDED|95.0|0.73|1.33|||Regression, Logistic|||Class activities about mental health||1.33|0.73|0.899
71718549|NCT05018689|142951753|SUPERIORITY||comparison of odds ratios|1.08||||0.612|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Mental health information on school website||1.48|0.80|0.612
71718550|NCT05018689|142951753|SUPERIORITY||comparison of odds ratios|1.14||||0.476|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||Other||1.65|0.79|0.476
71718551|NCT05018689|142951754|SUPERIORITY||Mean Difference (Net)|-0.09||||0.141|TWO_SIDED|95.0|-0.22|0.03|||Regression, Linear|||On average, how often do your teachers speak to you about your emotions and feelings?||0.03|-0.22|0.141
71718552|NCT05018689|142951755|SUPERIORITY||Mean Difference (Net)|0.04||||0.392|TWO_SIDED|95.0|-0.05|0.13|||Regression, Linear|||Would you like your teachers to speak to you about your emotions and feelings?||0.13|-0.05|0.392
71718553|NCT02379052|142951759|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7||||0.0304|TWO_SIDED|95.0|-3.22|-0.16|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.16|-3.22|0.0304
71718554|NCT02379052|142951760|SUPERIORITY||Least Squares Mean Difference|-26.45||||0.0312|TWO_SIDED|95.0|-50.523|-2.387|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-2.387|-50.523|0.0312
71718555|NCT02379052|142951761|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.383|TWO_SIDED|95.0|-2.48|0.96|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.96|-2.48|0.3830
71718556|NCT02379052|142951762|SUPERIORITY||Least Squares Mean Difference|-11.0||||0.4147|TWO_SIDED|95.0|-37.46|15.467|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||15.467|-37.460|0.4147
71718557|NCT02379052|142951763|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
71718558|NCT02379052|142951764|SUPERIORITY||Percent Difference|26.6||||0.049|TWO_SIDED|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method|||51.05|-3.04|0.0490
71718559|NCT02379052|142951765|SUPERIORITY||Least Squares Mean Difference|-23.23||||0.085|TWO_SIDED|95.0|-49.677|3.212|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||3.212|-49.677|0.0850
71718560|NCT02379052|142951766|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0635|TWO_SIDED|95.0|-28.54|0.78|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.78|-28.54|0.0635
71768566|NCT03811093|143037432|OTHER|||||||0.44|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||0.44
71718561|NCT02379052|142951767|SUPERIORITY||Least Squares Mean Difference|-33.65||||0.0608|TWO_SIDED|95.0|-68.828|1.536|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||1.536|-68.828|0.0608
71718562|NCT02379052|142951768|SUPERIORITY||Least Squares Mean Difference|-21.1||||0.0318|TWO_SIDED|95.0|-40.42|-1.86|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-1.86|-40.42|0.0318
71718563|NCT02379052|142951769|SUPERIORITY||Percent Difference|17.8||||0.1365|TWO_SIDED|95.0|-11.54|43.55||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||43.55|-11.54|0.1365
71718564|NCT02379052|142951770|SUPERIORITY||Percent Difference|35.0||||0.0044|TWO_SIDED|95.0|5.69|58.34||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo|||58.34|5.69|0.0044
71768567|NCT03811093|143037433|SUPERIORITY||Mean Difference (Net)|4.4703|||<|0.01|TWO_SIDED|95.0|2.3372|6.6034||p-value is computed using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.||6.6034|2.3372|<0.01
71768568|NCT03811093|143037433|OTHER|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209."||||.200
71768569|NCT03811093|143037433|OTHER|||||||0.438|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.||||.438
71768570|NCT00464490|143037434|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value \<0.05 was considered significant|t-test, 2 sided|||H(0): Ventilator time (DG) = Ventilator time (CG)||||0.02
71768571|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.5888|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Hgb||||0.5888
71768572|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Weight||||0.6600
71768573|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.7999|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline estimated glomerular filtration rate (eGFR)||||0.7999
71768574|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.2092|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Ethnicity||||0.2092
71718565|NCT02379052|142951771|SUPERIORITY||Least Squares Mean Difference|-107.13|||<|0.0001|TWO_SIDED|95.0|-141.215|-73.046|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-73.046|-141.215|<0.0001
71718566|NCT02379052|142951772|SUPERIORITY||Least Square Mean Difference|-1.6||||0.0006|TWO_SIDED|95.0|-2.5|-0.68|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||-0.68|-2.50|0.0006
71718567|NCT02379052|142951773|SUPERIORITY||Least Squares Mean Difference|0.33||||0.091|TWO_SIDED|95.0|-0.053|0.72|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values (\[seeds = 12345 \& 54321 in the 2 steps respectively; number of imputations=50\]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.|||0.720|-0.053|0.0910
71718568|NCT04419467|142951782|SUPERIORITY||GM % treatment difference (80% CI)|-0.5||||0.485|TWO_SIDED|80.0|-14.8|16.3||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.|||16.3|-14.8|0.485
71718569|NCT04419467|142951782|SUPERIORITY||GM % treatment difference (80% CI)|8.6||||0.75|TWO_SIDED|80.0|-7.2|27.2||One-sided p-value|Mixed Models Repeated Measures Analysis||Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean, then expressed as percent treatment difference|||27.2|-7.2|0.750
71718570|NCT05501639|142951822|OTHER|||||||0.758|||||||Log Rank|||||||0.758
71718571|NCT05501639|142951823|OTHER|||||||0.474|||||||Log Rank|||||||0.474
71718572|NCT05501639|142951824|OTHER|||||||0.472|||||||Chi-squared|||||||0.472
71718573|NCT05501639|142951825|OTHER||Incidence rate ratio|0.647|||||TWO_SIDED|95.0|0.261|1.604|||||Incidence rate ratio at 6 months|||1.604|0.261|
71718574|NCT05501639|142951825|OTHER||Incidence rate ratio|1.005|||||TWO_SIDED|95.0|0.513|1.969|||||Incidence rate ratio at 12 months|||1.969|0.513|
71718575|NCT05501639|142951826|OTHER|||||||0.222|||||||Chi-squared|||Hospitalisations||||0.222
71718576|NCT05501639|142951826|OTHER|||||||0.553|||||||Chi-squared|||Asthma-related hospitalisations||||0.553
71718577|NCT05501639|142951826|OTHER|||||||0.192|||||||Chi-squared|||ED visits||||0.192
71718578|NCT05501639|142951826|OTHER|||||||0.383|||||||Chi-squared|||Asthma-related ED visits||||0.383
71718579|NCT05501639|142951826|OTHER|||||||0.338|||||||Chi-squared|||OP visits||||0.338
71718580|NCT05501639|142951826|OTHER||||||<|0.0001|||||||Chi-squared|||Asthma-related OP visits||||<0.0001
71718581|NCT05501639|142951827|OTHER|||||||0.538|||||||t-test, 2 sided|||Hospitalisations||||0.538
71718582|NCT05501639|142951827|OTHER|||||||0.913|||||||t-test, 2 sided|||Asthma-related hospitalisations||||0.913
71718583|NCT05501639|142951827|OTHER|||||||0.688|||||||t-test, 2 sided|||ED visits||||0.688
71718584|NCT05501639|142951827|OTHER|||||||0.892|||||||t-test, 2 sided|||Asthma-related ED visits||||0.892
71718585|NCT05501639|142951827|OTHER||||||<|0.0001|||||||t-test, 2 sided|||OP visits||||<0.0001
71718586|NCT05501639|142951827|OTHER|||||||0.002|||||||t-test, 2 sided|||Asthma-related OP visits||||0.002
71718587|NCT05501639|142951828|OTHER|||||||0.378|||||||Chi-squared|||||||0.378
71718588|NCT00003869|142951864|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||||||0.54
71718589|NCT00003869|142951865|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
71718590|NCT00003869|142951866|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Log Rank|||||||0.50
71718591|NCT00003869|142951867|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Fisher Exact|||||||0.04
71718592|NCT00003869|142951868|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
71718593|NCT00142792|142951908|SUPERIORITY_OR_OTHER|||||||0.18||||||Time by group interaction effect, F(2,372) = 1.8, p =0.18)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.||||0.18
71718594|NCT00142792|142951908|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=87.7, p\<0.001)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
71718595|NCT00142792|142951909|SUPERIORITY_OR_OTHER|||||||0.27||||||time by group interaction effect, F(2,373) = 1.3, p =0.27|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||0.27
71718596|NCT00142792|142951909|SUPERIORITY||||||<|0.001||||||time effect, F(1,109)=91.1, p\<0.001|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||||||<0.001
71718597|NCT01333436|142951910|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.8|STANDARD_DEVIATION|36.8||0.0078||95.0|||||t-test, 2 sided|||||||0.0078
71718598|NCT01333436|142951911|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.5|STANDARD_DEVIATION|13.9||0.0675||95.0|||||t-test, 2 sided|||||||0.0675
71718599|NCT01333436|142951912|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|4.8||0.1798||95.0|||||t-test, 2 sided|||||||0.1798
71718600|NCT00444106|142951913|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sided exact test for a single propn.|One-sided exact test for a single proportion.||"One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.~Increase in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms."||||<.0001
71887390|NCT02554929|143295646|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.42||0.002|TWO_SIDED|95.0|-0.91|0.74||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||0.74|-0.91|0.002
71890225|NCT01795547|143302089|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was \> -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D \> -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was \>0.|Least Squares Mean Difference|4.666||||0.036|TWO_SIDED|95.0|0.316|9.015|||Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.||9.015|0.316|0.036
71718601|NCT00953706|142951941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1509|TWO_SIDED|95.0|-0.6|4.1|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.||4.1|-0.6|0.1509
71718602|NCT00953706|142951942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.1||0.5408|TWO_SIDED|95.0|-2.9|5.6|||Mixed Models Analysis|||Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with the dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for for age and baseline value for CFQ-R score, using unstructured covariance matrix||5.6|-2.9|0.5408
71718603|NCT00953706|142951943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.4||0.0384|TWO_SIDED|95.0|-5.6|-0.2|||Mixed Models Analysis|||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous age and baseline value for age, sweat chloride, using unstructured covariance matrix.||-0.2|-5.6|0.0384
71718604|NCT00953706|142951944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.7265|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|||The analysis used the linear mixed model with treatment as fixed effects, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group (\< 18 years and ≥ 18 years) and percent predicted forced expiratory volume (FEV1) severity (\< 70%, ≥ 70% to ≤ 90%, \> 90%) at screening, with random intercept and random slope. Rate of change in the study period is the slope of weight versus time (days) multiplied by the number of days in the study period (112 days).||0.7|-1.1|0.7265
71718605|NCT02137070|142951956|SUPERIORITY||||||<|0.01||||||Voxel-size (p-FWE \< 0.01) and voxel-peak (p-unc \< 0.001) were corrected for multiple comparisons.|2x2 Factorial ANOVA in CONN|2x2 Factorial ANOVA in CONN - Group (Bariatric surgery vs. control) \& time (pre-surgery baseline vs. 18-month follow-up)||Analysis of variance comparing change scores from 18 months post-surgery relative to pre-surgical baseline were performed. Change in the surgical group was compared to change for the non-surgical controls. The dependent measures were connectivity strengths seeding from the hippocampus and left dorsal lateral pre-frontal cortex to other cortical areas.||||<0.01
71829379|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.1||0.4492|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.4492
71829380|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.2539|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.2539
71718606|NCT02292537|142951995|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.91||1e-07|TWO_SIDED|95.0|3.1|6.7|||ANCOVA|ANCOVA model with treatment group as a factor and age at Screening and baseline HFMSE score as covariates.||||6.7|3.1|0.0000001
71718607|NCT02292537|142951996|SUPERIORITY||Odds Ratio (OR)|5.59||||0.0006|TWO_SIDED|95.0|2.09|14.91||Based on multiple imputation and logistic regression with treatment effect and adjustment for each participant's age at screening and HFMSE score at baseline.|Regression, Logistic|||||14.91|2.09|0.0006
71718608|NCT02292537|142951996|SUPERIORITY||Difference in Proportions|30.5|||||TWO_SIDED|95.0|12.74|48.31|||||Difference in proportions of Nusinersen minus Sham Procedure are from multiple imputation procedure and are based on binomial proportions.|||48.31|12.74|
71718609|NCT02292537|142951997|SUPERIORITY||Difference in Proportions|13.8||||0.0811|TWO_SIDED|95.0|-6.64|34.17|||Fisher Exact||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||34.17|-6.64|0.0811
71829381|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.8168|ONE_SIDED|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.22|0.8168
71829382|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3248|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3248
71718610|NCT02292537|142951998|SUPERIORITY||LS Mean Difference|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and number of milestones at baseline.|||0.7|0.2|
71718611|NCT02292537|142951999|SUPERIORITY||LS Mean Differenec|3.7|||||TWO_SIDED|95.0|2.3|5.0|||||From multiple imputation procedure, based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and derived total score at baseline.|||5.0|2.3|
71718612|NCT02292537|142952000|SUPERIORITY||Difference in Proportions|-1.4|||||TWO_SIDED|95.0|-21.84|19.34|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||19.34|-21.84|
71718613|NCT02292537|142952001|SUPERIORITY||Difference in Proportions|1.5|||||TWO_SIDED|95.0|-19.1|22.1|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.|||22.10|-19.10|
71718614|NCT01415583|142952010|NON_INFERIORITY|Consistent with the noninferiority design, the null hypothesis states that the bleeding rate in patients receiving perioperative dexamethasone differed from the bleeding rate in patients receiving perioperative placebo; the alternative hypothesis states that the bleeding rate with dexamethasone is not greater than placebo by more than the noninferiority margin.||||||0.05|||||||t-test, 1 sided|||||||0.05
71718615|NCT01415583|142952010|NON_INFERIORITY|This noninferiority margin was set at 5%, meaning a difference in bleeding rates that did not exceed 5% would be taken as evidence that the bleeding with dexamethasone is not greater than that with placebo by more than 5%.||||||0.05|||||||t-test, 1 sided|||||||0.05
71718616|NCT00552071|142952016|OTHER|||||||0.4||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.40
71718617|NCT00552071|142952017|OTHER|||||||0.43||||||A two-sided p value of \<0.05 was considered significant.|t-test, 2 sided|||||||0.43
71718618|NCT01979614|142952018|SUPERIORITY_OR_OTHER||Standard Error|-0.1116||||0.438|TWO_SIDED|95.0|-0.399|0.176|||ANCOVA|||SAP for Global Myocardial Perfusion Reserve Index (MPRI)||0.176|-0.399|0.438
71718619|NCT00756275|142952027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33|||<|0.05|TWO_SIDED|95.0|0.91|20.56|||Chi-squared|||||20.56|.91|<0.05
71718620|NCT00756275|142952028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.36||0.5|TWO_SIDED|95.0|-6.29|3.11|||t-test, 2 sided|||||3.11|-6.29|.50
71718621|NCT00756275|142952029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3|TWO_SIDED|95.0|0.58|14.5|||Fisher Exact|||||14.50|.58|.30
71718622|NCT00756275|142952030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.98|STANDARD_ERROR_OF_MEAN|8.38||0.34|TWO_SIDED|95.0|-24.64|8.68|||t-test, 2 sided|||||8.68|-24.64|.34
71718623|NCT00756275|142952031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.39|STANDARD_ERROR_OF_MEAN|8.1||0.36|TWO_SIDED|95.0|-8.73|23.52|||t-test, 2 sided|||||23.52|-8.73|.36
71718624|NCT00756275|142952032|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||||||.57
71718625|NCT00756275|142952033|SUPERIORITY_OR_OTHER|||||||0.31|||||||Chi-squared|||||||.31
71718626|NCT00756275|142952034|SUPERIORITY_OR_OTHER|||||||0.72|||||||Chi-squared|||||||.72
71718627|NCT00756275|142952035|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||||||.18
71718628|NCT00756275|142952036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.72||0.75|TWO_SIDED|95.0|-3.98|2.87|||t-test, 2 sided|||||2.87|-3.98|.75
71718629|NCT01244035|142952126|OTHER||LS Mean difference|1.1||||0.1325|TWO_SIDED|90.0|-0.54|2.74|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.74|-0.54|0.1325
71718630|NCT01244035|142952126|OTHER||LS Mean difference|4.16|||<|0.001|TWO_SIDED|90.0|2.53|5.79|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||5.79|2.53|<0.001
71718631|NCT01244035|142952126|OTHER||LS Mean difference|-3.06||||0.0016|TWO_SIDED|90.0|-4.7|-1.42|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-1.42|-4.70|0.0016
71718632|NCT01244035|142952127|OTHER||LS Mean difference|-2.94||||0.0212|TWO_SIDED|90.0|-5.3|-0.57|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.57|-5.30|0.0212
71718633|NCT01244035|142952127|OTHER||LS Mean difference|-2.76||||0.0299|TWO_SIDED|90.0|-5.16|-0.36|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||-0.36|-5.16|0.0299
71718634|NCT01244035|142952127|OTHER||LS Mean difference|-0.18||||0.4506|TWO_SIDED|90.0|-2.54|2.19|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.||||2.19|-2.54|0.4506
71829383|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.3148|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.3148
71718635|NCT03723980|142952133|SUPERIORITY||Mean Difference (Net)|2.96||||0.329|TWO_SIDED|95.0||||"the calculated p value is for time interval of 4 hours~threshold for statistical significance= \<0.05"|ANOVA|For multiple comparisons between groups, post hoc (LSD) was applied||||||0.329
71718636|NCT03723980|142952133|SUPERIORITY||Mean Difference (Net)|-0.92||||0.764|TWO_SIDED|95.0||||"The calculated p value is for time interval of 12 hours~threshold for statistical significance= \<0.05"|ANOVA|||||||0.764
71718637|NCT03723980|142952133|SUPERIORITY||Mean Difference (Net)|-1.57||||0.605|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 2~threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
71718638|NCT03723980|142952133|SUPERIORITY||Mean Difference (Net)|-0.82||||0.786|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 3~threshold for statistical significance= \<0.05"|ANOVA|||||||0.786
71718639|NCT03723980|142952133|SUPERIORITY||Mean Difference (Net)|-0.72||||0.813|TWO_SIDED|95.0||||"The calculated p value is for time interval of day 4~threshold for statistical significance= \<0.05"|ANOVA|||||||0.813
71718640|NCT03723980|142952135|OTHER||Mean Difference (Net)|2.97|STANDARD_ERROR_OF_MEAN|3.0||0.334|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.334
71718641|NCT03723980|142952135|OTHER||Mean Difference (Net)|2.33|STANDARD_ERROR_OF_MEAN|3.0||0.448|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.448
71718642|NCT03723980|142952135|OTHER||Mean Difference (Net)|5.88|STANDARD_ERROR_OF_MEAN|3.0||0.056|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.056
71718643|NCT03723980|142952135|OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.0||0.76|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.760
71718644|NCT03723980|142952135|OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|3.0||0.828|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.828
71718645|NCT03723980|142952135|OTHER||Mean Difference (Net)|11.8|STANDARD_ERROR_OF_MEAN|2.9||0|TWO_SIDED|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.000
71718646|NCT03723980|142952135|OTHER||Mean Difference (Net)|-1.54|STANDARD_ERROR_OF_MEAN|2.9||0.605|TWO_SIDED|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.605
71718647|NCT03723980|142952135|OTHER||Mean Difference (Net)|5.23|STANDARD_ERROR_OF_MEAN|2.9||0.8|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.80
71718648|NCT03723980|142952135|OTHER||Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.574
71718649|NCT03723980|142952135|OTHER||Mean Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|2.9||0.796|TWO_SIDED|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= \<0.05"|ANOVA|||||||0.796
71718650|NCT03723980|142952136|OTHER||Mean Difference (Net)|-0.6||||0.412|TWO_SIDED|||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.412
71718651|NCT03723980|142952136|OTHER||Mean Difference (Net)|2.8||||0.94|TWO_SIDED|||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.94
71718652|NCT03723980|142952136|OTHER||Mean Difference (Net)|5.5||||0.035|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 2~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.035
71718653|NCT03723980|142952136|OTHER||Mean Difference (Net)|4.4||||0.023|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 3~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.023
71718654|NCT03723980|142952136|OTHER||Median Difference (Net)|4.3||||0.02|TWO_SIDED|||||"The p-value calculated is for pain score difference at Day 4.~Threshold for statistical significance= \<0.05"|Wilcoxon (Mann-Whitney)|||||||0.020
71718655|NCT03723980|142952137|OTHER|||||||0.15||||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.15
71718656|NCT03723980|142952137|OTHER|||||||0.36||||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.36
71718657|NCT03723980|142952137|OTHER|||||||0.13||||||"The p-value calculated is for pain score difference at day 2~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.13
71718658|NCT03723980|142952137|OTHER|||||||0.55||||||"The p-value calculated is for pain score difference at day 3~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.55
71718659|NCT03723980|142952137|OTHER|||||||0.17||||||"The p-value calculated is for pain score difference at day 4~Threshold for statistical significance= \<0.05"|Kruskal-Wallis|||||||0.17
71718660|NCT04512001|142952142|EQUIVALENCE|Margins for results to be considered equivalent: -0.6 to 0.5.|Least squares means difference|0.01|||||TWO_SIDED|90.0|-0.16|0.18||||||||0.18|-0.16|
71718661|NCT04512001|142952144|EQUIVALENCE|Margins for results to be considered equivalent: -15%, 15%.|Difference in % Response Rate|-3.94|||||TWO_SIDED|95.0|-9.97|2.11||||||||2.11|-9.97|
71718662|NCT03198767|142952154|SUPERIORITY||Ratio of number of events|0.71||||0.202|TWO_SIDED|80.0|0.5|1.0|||Mixed Models Analysis|||Day 3||1.00|0.50|0.202
71718663|NCT03198767|142952154|SUPERIORITY||Ratio of number of events|0.21|||<|0.001|TWO_SIDED|80.0|0.14|0.32|||Mixed Models Analysis|||Day 3||0.32|0.14|<0.001
71718664|NCT03198767|142952154|SUPERIORITY||Ratio of number of events|0.3|||<|0.001|TWO_SIDED|80.0|0.19|0.46|||Mixed Models Analysis|||Day 3||0.46|0.19|<0.001
71718665|NCT03198767|142952154|SUPERIORITY||Ratio of number of events|0.79||||0.275|TWO_SIDED|80.0|0.6|1.04|||Mixed Models Analysis|||Day 3||1.04|0.60|0.275
71718666|NCT03198767|142952154|SUPERIORITY||Ratio of number of events|0.78||||0.234|TWO_SIDED|80.0|0.59|1.02|||Mixed Models Analysis|||Day 3||1.02|0.59|0.234
71718667|NCT03198767|142952154|SUPERIORITY||Ratio of number of events|0.98||||0.921|TWO_SIDED|80.0|0.73|1.3|||Mixed Models Analysis|||Day 3||1.30|0.73|0.921
71718668|NCT03198767|142952155|SUPERIORITY||Ratio of number of events|0.68||||0.04|TWO_SIDED|80.0|0.54|0.86|||Mixed Models Analysis|||||0.86|0.54|0.040
71718669|NCT03198767|142952155|SUPERIORITY||Ratio of number of events|0.37|||<|0.001|TWO_SIDED|80.0|0.28|0.49|||Mixed Models Analysis|||||0.49|0.28|<0.001
71718670|NCT03198767|142952155|SUPERIORITY||Ratio of number of events|0.54||||0.008|TWO_SIDED|80.0|0.41|0.72|||Mixed Models Analysis|||||0.72|0.41|0.008
71718671|NCT03198767|142952155|SUPERIORITY||Ratio of number of events|0.79||||0.141|TWO_SIDED|80.0|0.65|0.97|||Mixed Models Analysis|||||0.97|0.65|0.141
71718672|NCT03198767|142952155|SUPERIORITY||Ratio of number of events|0.9||||0.51|TWO_SIDED|80.0|0.74|1.1|||Mixed Models Analysis|||||1.10|0.74|0.510
71718673|NCT03198767|142952155|SUPERIORITY||Ratio of number of events|1.14||||0.401|TWO_SIDED|80.0|0.93|1.41|||Mixed Models Analysis|||||1.41|0.93|0.401
71718674|NCT03198767|142952156|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.426|TWO_SIDED|80.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.426
71718675|NCT03198767|142952156|SUPERIORITY||Median Difference (Final Values)|-1.06||||0.001|TWO_SIDED|80.0|-1.46|-0.67|||Mixed Models Analysis|||||-0.67|-1.46|0.001
71718676|NCT03198767|142952156|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.009|TWO_SIDED|80.0|-1.25|-0.45|||Mixed Models Analysis|||||-0.45|-1.25|0.009
71718677|NCT03198767|142952156|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.135|TWO_SIDED|80.0|-0.68|-0.05|||Mixed Models Analysis|||||-0.05|-0.68|0.135
71718678|NCT03198767|142952156|SUPERIORITY||Median Difference (Final Values)|-0.19||||0.436|TWO_SIDED|80.0|-0.5|0.12|||Mixed Models Analysis|||||0.12|-0.50|0.436
71718679|NCT03198767|142952156|SUPERIORITY||Median Difference (Final Values)|0.18||||0.452|TWO_SIDED|80.0|-0.13|0.49|||Mixed Models Analysis|||||0.49|-0.13|0.452
71718680|NCT00570323|142952159|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
71718681|NCT04232943|142952167|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.56|2.464|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 1||2.464|0.560|
71718682|NCT04232943|142952167|OTHER|This study was designed to provide at least 96% power to detect ≥ 60% reduction in shedding rate in the IPV+ dmLT group assuming the shedding rate in the IPV alone group is at least 80%.|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.606|1.51|||||RR = Ratio of proportions: (IPV+dmLT) / IPV|Analysis of Shedding of Poliovirus Type 3||1.510|0.606|
71718683|NCT03896477|142952187|OTHER||GMC Ratio|2.91|||||TWO_SIDED|95.0|2.47|3.44||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||3.44|2.47|
71718684|NCT03896477|142952187|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.23|1.69||||||Serotype 1 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.69|1.23|
71718685|NCT03896477|142952187|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.66|2.25||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.25|1.66|
71718686|NCT03896477|142952187|OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 5 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.88|0.65|
71718687|NCT03896477|142952187|OTHER||GMC Ratio|16.03|||||TWO_SIDED|95.0|12.84|20.03||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||20.03|12.84|
71829384|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6563|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.6563
71718688|NCT03896477|142952187|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06||||||Serotype 6A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.06|0.72|
71718689|NCT03896477|142952187|OTHER||GMC Ratio|2.51|||||TWO_SIDED|95.0|2.14|2.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.95|2.14|
71718690|NCT03896477|142952187|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||Serotype 6B geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.95|0.68|
71718691|NCT03896477|142952187|OTHER||GMC Ratio|2.11|||||TWO_SIDED|95.0|1.83|2.44||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.44|1.83|
71718692|NCT03896477|142952187|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||Serotype 7F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.91|
71718693|NCT03896477|142952187|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.21|1.65||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.65|1.21|
71718694|NCT03896477|142952187|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.76|1.05||||||Serotype 9V geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.05|0.76|
71718695|NCT03896477|142952187|OTHER||GMC Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.1||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.10|1.29|
71718696|NCT03896477|142952187|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.73|1.12||||||Serotype 14 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.12|0.73|
71718697|NCT03896477|142952187|OTHER||GMC Ratio|3.69|||||TWO_SIDED|95.0|2.91|4.67||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||4.67|2.91|
71718698|NCT03896477|142952187|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.87||||||Serotype 19A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.87|0.60|
71718699|NCT03896477|142952187|OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.79||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.79|0.52|
71718700|NCT03896477|142952187|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.62|0.89||||||Serotype 19F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||0.89|0.62|
71829385|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.1735|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1735
71718701|NCT03896477|142952187|OTHER||GMC Ratio|2.29|||||TWO_SIDED|95.0|1.89|2.76||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||2.76|1.89|
71718702|NCT03896477|142952187|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 23F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.||1.22|0.82|
71718703|NCT01000506|142952225|SUPERIORITY_OR_OTHER||Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.69||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.69|0.39|<0.001
71718704|NCT01000506|142952225|SUPERIORITY_OR_OTHER||Rate Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.81||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.81|0.46|<0.001
71718705|NCT01000506|142952225|SUPERIORITY_OR_OTHER||Rate Ratio|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.64||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.36|<0.001
71718706|NCT02185534|142952268|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|104.43|||||TWO_SIDED|90.0|92.27|118.19|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||118.19|92.27|
71718707|NCT02185534|142952268|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|Geometric mean ratio|97.19|||||TWO_SIDED|90.0|81.12|116.45|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25||116.45|81.12|
71718708|NCT02185534|142952269|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|108.06|||||TWO_SIDED|90.0|95.46|122.33|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||122.33|95.46|
71718709|NCT02185534|142952269|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|105.79|||||TWO_SIDED|90.0|95.22|117.53|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||117.53|95.22|
71718710|NCT02185534|142952270|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|93.94|||||TWO_SIDED|90.0|87.12|101.29|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel|||101.29|87.12|
71718711|NCT02185534|142952270|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|92.03|||||TWO_SIDED|90.0|84.91|99.75|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|||99.75|84.91|
71768575|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.9996||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Geographic Ancestry||||0.9996
71829386|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.12||0.1237|ONE_SIDED|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.06|0.1237
71718712|NCT02041299|142952271|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 96.01% confidence interval (CI) is less than or equal to 2 mg/g dw.|Mean Difference (Net)|0.26||||0.0399|TWO_SIDED|96.01|-0.97|1.48|||ANCOVA|||||1.48|-0.97|0.0399
71718713|NCT02041299|142952272|NON_INFERIORITY|Support for non-inferiority is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|-0.000295||||0.0399|TWO_SIDED|96.01|-0.054247|0.053657|||ANCOVA|||Data for this measure were log-transformed.||0.053657|-0.054247|0.0399
71768576|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Sex||||0.7002
71829387|NCT00430300|143163112|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.11||0.6113|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.6113
71718714|NCT02041299|142952273|NON_INFERIORITY|Support for non-inferiority of deferiprone to deferoxamine in serum ferritin is demonstrated if the 96.01% CI contains zero (0)|Mean Difference (Net)|375.07||||0.0399|TWO_SIDED|96.01|-260.63|1010.76|||ANCOVA|||||1010.76|-260.63|0.0399
71718715|NCT02041299|142952274|SUPERIORITY|Comparison of treatment groups on change in score on SF-36 Physical Summary||||||0.9214|||||||ANCOVA|||||||0.9214
71718716|NCT02041299|142952274|SUPERIORITY|||||||0.1174|||||||ANCOVA|||Comparison of treatment groups on change in score on SF-36 Mental Summary||||0.1174
71718717|NCT02041299|142952274|SUPERIORITY|||||||0.6488|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Physical Summary||||0.6488
71718718|NCT02041299|142952274|SUPERIORITY|||||||0.5915|||||||ANCOVA|||Comparison of treatment groups on change in score on CHQ-PF50 Psychosocial Summary||||0.5915
71718719|NCT02389465|142952275|OTHER|||||||0.44|||||||t-test, 2 sided|||IL6 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.44
71829388|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.5549|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.5549
71718720|NCT02389465|142952275|OTHER|||||||0.11|||||||t-test, 2 sided|||IL6 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.11
71718721|NCT02389465|142952275|OTHER|||||||0.42|||||||t-test, 2 sided|||IL6 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.42
71718722|NCT02389465|142952275|OTHER|||||||0.49|||||||t-test, 2 sided|||IL-6 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-tes||||.49
71718723|NCT02389465|142952275|OTHER|||||||0.23|||||||t-test, 2 sided|||IL6 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.23
71718724|NCT02389465|142952276|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram + celecoxib groups||||.003
71718725|NCT02389465|142952276|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and escitalopram groups||||<.001
71718726|NCT02389465|142952276|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||MADRS scores at the final visit compared between the healthy control and placebo groups||||.034
71718727|NCT02389465|142952276|SUPERIORITY|||||||0.03|||||||ANCOVA|||MADRS scores at the final visit compared between the placebo groups and all groups receiving escitalopram (both with and without celecoxib)||||.03
71718728|NCT02389465|142952277|OTHER|||||||0.29|||||||t-test, 2 sided|||IL10 levels in healthy controls pre- and post-treatment compared using a paired t-test||||.29
71718729|NCT02389465|142952277|OTHER|||||||0.19|||||||t-test, 2 sided|||IL10 levels in the placebo group pre- and post-treatment compared using a paired t-test||||.19
71718730|NCT02389465|142952277|OTHER|||||||0.5|||||||t-test, 2 sided|||IL10 levels in the escitalopram group pre- and post-treatment compared using a paired t-test||||.5
71718731|NCT02389465|142952277|OTHER|||||||0.55|||||||t-test, 2 sided|||IL10 levels in the escitalopram + celecoxib group pre- and post-treatment compared using a paired t-test||||.55
71718732|NCT02389465|142952277|OTHER|||||||0.06|||||||t-test, 2 sided|||IL10 levels at completion of study compared between all MDD groups (placebo, escitalopram, and escitalopram + celecoxib) and the healthy control group||||.06
71718733|NCT00361972|142952296|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71718734|NCT00361972|142952297|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71718735|NCT00503425|142952299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 1.|t-test, 2 sided|||||||<0.0001
71718736|NCT00503425|142952299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 2.|t-test, 2 sided|||||||<0.0001
71718737|NCT00503425|142952299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 3.|t-test, 2 sided|||||||<0.0001
71829389|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.988|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.9880
71718738|NCT00503425|142952299|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 4.|t-test, 2 sided|||||||0.0001
71718739|NCT00437268|142952310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.431||||||The type 1 error rate was set at 0.20|Log Rank|||||||0.431
71718740|NCT00437268|142952311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593|||||||Fisher Exact|||||||0.593
71718741|NCT00437268|142952312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Log Rank|||||||0.157
71718742|NCT00437268|142952313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||Kaplan-Meier analysis was used for statistical analysis.|Log Rank|||||||0.539
71718743|NCT00437268|142952314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.695|||||||Fisher Exact|||||||0.695
71718744|NCT00444925|142952316|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).||||<0.0001
71768577|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.5536||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Age||||0.5536
71768578|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Co-administration with food||||0.0085
71718745|NCT00444925|142952316|SUPERIORITY_OR_OTHER|||||||0.0107||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0107
71718746|NCT00444925|142952316|SUPERIORITY_OR_OTHER|||||||0.0172||95.0||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0172
71718747|NCT00444925|142952317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71718748|NCT00444925|142952317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71718749|NCT00444925|142952317|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.8460
71718750|NCT00444925|142952317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71718751|NCT00444925|142952317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71718752|NCT00444925|142952317|SUPERIORITY_OR_OTHER|||||||0.1937||95.0|||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1937
71829390|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.8572|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.8572
71829391|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.8402|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.8402
71829392|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6562|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.6562
71829393|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.5632|ONE_SIDED|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.08|0.5632
71829394|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.637|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.6370
71768579|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Diabetic||||0.0021
71829395|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.4686|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.4686
71829396|NCT00430300|143163113|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.6164|ONE_SIDED|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.11|0.6164
71829397|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.9885|ONE_SIDED|95.0|-2.4||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.4|0.9885
71829398|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.8055|ONE_SIDED|95.0|-1.5||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.5|0.8055
71829399|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.5||0.9759|ONE_SIDED|95.0|-2.0||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.0|0.9759
71829400|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.4401|ONE_SIDED|95.0|-1.1||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.1|0.4401
71829401|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.5957|ONE_SIDED|95.0|-1.4||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.4|0.5957
71718753|NCT00444925|142952318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71718754|NCT00444925|142952318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71718755|NCT00444925|142952318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718756|NCT00444925|142952318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718757|NCT00444925|142952318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71768580|NCT01587898|143037501|SUPERIORITY_OR_OTHER|||||||0.2194||95.0|||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Region||||0.2194
71829402|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.8302|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.8302
71829403|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.9657|ONE_SIDED|95.0|-3.1||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-3.1|0.9657
71829404|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.6378|ONE_SIDED|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.7|0.6378
71829405|NCT00430300|143163121|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.899|ONE_SIDED|95.0|-2.2||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-2.2|0.8990
71890226|NCT01795547|143302090|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.492||||0.043|TWO_SIDED|95.0|-2.935|-0.049||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.049|-2.935|0.043
71829406|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.15||0.8757|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8757
71829407|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6334|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6334
71829408|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.5448|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.5448
71887391|NCT02554929|143295646|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.62||0.002|TWO_SIDED|95.0|-0.95|1.48||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||1.48|-0.95|0.002
71718758|NCT00444925|142952318|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71718759|NCT00444925|142952318|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0220
71718760|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|3.4||0.0214|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0214
71718761|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.4||0.0149|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0149
71718762|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.8659|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.8659
71718763|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71718764|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|4.0||0.0036|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0036
71718765|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.3||0.1484|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1484
71718766|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718767|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|4.1||0.1029|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.1029
71718768|NCT00444925|142952319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|3.3||0.0048|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0048
71718769|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0002|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0002
71718770|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0006|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0006
71718771|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7395|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7395
71718772|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71718773|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0007|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.0007
71718774|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4185|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.4185
71718775|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718776|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0005
71718777|NCT00444925|142952320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3798|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.3798
71718778|NCT00444925|142952321|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
71718779|NCT00444925|142952321|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0002
71718780|NCT00444925|142952321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718781|NCT00444925|142952321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718782|NCT00444925|142952321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
71718783|NCT00444925|142952321|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0003
71656997|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|766.64||||0.2976|TWO_SIDED|95.0|-703.26|2236.54||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2236.54|-703.26|0.2976
71718784|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.273|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.2730
71718785|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0652|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0652
71768581|NCT01903252|143037547|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|Risk Difference (RD)|-2.2||||0.005|TWO_SIDED|95.0|-8.1|3.8|||Non-inferiority|||If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.||3.8|-8.1|0.005
71768582|NCT01903252|143037548|SUPERIORITY_OR_OTHER||Percentag|75.3|||||TWO_SIDED|95.0|69.4|80.6||||||||80.6|69.4|
71768583|NCT01903252|143037550|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority|Risk Difference (RD)|-2.1|||<|0.001|TWO_SIDED|95.0|-6.5|2.2|||Non-inferiority|||||2.2|-6.5|<0.001
71768584|NCT01903252|143037551|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.1||||0.026|TWO_SIDED|95.0|-10.1|3.9|||Non-inferiority|||||3.9|-10.1|0.026
71768585|NCT01903252|143037552|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-4.8||||0.048|TWO_SIDED|95.0|-10.9|1.4|||Non-inferiority|||||1.4|-10.9|0.048
71768586|NCT01903252|143037553|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.1|||Non-inferiortiy|||||3.1|-10.8|0.042
71768587|NCT01903252|143037554|NON_INFERIORITY|Non-Inferiority|Risk Difference (RD)|-4.2||||0.048|TWO_SIDED|95.0|-11.0|2.7|||Non-inferiority|||||2.7|-11.0|0.048
71768588|NCT01903252|143037555|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-5.3||||0.068|TWO_SIDED|95.0|-11.5|0.9|||Non-inferiority|||||0.9|-11.5|0.068
71768589|NCT01903252|143037556|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-2.9||||0.021|TWO_SIDED|95.0|-9.8|4.0|||Non-inferiortiy|||||4.0|-9.8|0.021
71768590|NCT01903252|143037557|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.4||||0.031|TWO_SIDED|95.0|-10.3|3.7|||Non-inferiortiy|||||3.7|-10.3|0.031
71768591|NCT01903252|143037558|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.7||||0.013|TWO_SIDED|95.0|-9.2|1.8|||Non-inferiority|||||1.8|-9.2|0.013
71768592|NCT01903252|143037559|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Risk Difference (RD)|-3.9||||0.042|TWO_SIDED|95.0|-10.8|3.0|||Non-inferiority|||||3.0|-10.8|0.042
71768593|NCT01903252|143037560|OTHER||Mean Difference (Net)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.557
71768594|NCT01903252|143037561|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.987
71768595|NCT01903252|143037562|OTHER||Mean Difference (Net)|0.1||||0.455|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided||The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).|||0.2|-0.1|0.455
71768596|NCT01903252|143037563|OTHER||Mean Difference (Net)|0.0||||0.937|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided||The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.|||0.1|-0.1|0.937
71768597|NCT01903252|143037564|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.357
71768598|NCT01903252|143037565|OTHER||Mean Difference (Net)|-0.1||||0.099|TWO_SIDED|95.0|-0.2|0.0|||t-test, 2 sided|||||0.0|-0.2|0.099
71768599|NCT01903252|143037566|OTHER||Percentage|21.8|||||TWO_SIDED|95.0|16.8|27.5||||||||27.5|16.8|
71768600|NCT01903252|143037567|OTHER||Percentage|60.1|||||TWO_SIDED|95.0|53.6|66.3||||||||66.3|53.6|
71768601|NCT01903252|143037568|OTHER||Percentage|26.3|||||TWO_SIDED|95.0|20.9|32.3||||||||32.3|20.9|
71768602|NCT01903252|143037569|OTHER||Percentage|44.9|||||TWO_SIDED|95.0|38.5|51.3||||||||51.3|38.5|
71768603|NCT01903252|143037570|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.5||||||||1.5|0.0|
71768604|NCT03467685|143037581|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71768605|NCT01227824|143037587|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was \> -10%.|Difference in percentage|2.5|||||TWO_SIDED|95.0|-2.2|7.1|||||Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: baseline HIV-1 RNA and background dual NRTI.|||7.1|-2.2|
71768606|NCT03836001|143037599|SUPERIORITY|||||||0.59||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.59
71768607|NCT03836001|143037600|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
71768608|NCT03836001|143037601|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
71768609|NCT03836001|143037602|SUPERIORITY|||||||0.67||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||0.67
71768610|NCT03836001|143037603|SUPERIORITY|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||||||1
71768611|NCT03836001|143037604|OTHER||Mean Difference (Net)|-0.11||||0.09|TWO_SIDED|95.0|-0.24|0.02||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.02|-0.24|0.09
71768612|NCT03836001|143037605|SUPERIORITY||Mean Difference (Net)|-0.08||||0.16|TWO_SIDED|95.0|-0.19|0.03||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||0.03|-0.19|0.16
71718786|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.3503|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3503
71718787|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2667|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||0.2667
71718788|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1643|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||0.1643
71718789|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7264|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.7264
71718790|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3269|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||0.3269
71718791|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5059|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.5059
71718792|NCT00444925|142952322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.699|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.6990
71718793|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0008
71718794|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71718795|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.382|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.3820
71718796|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71718797|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71718798|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3498|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3498
71718799|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718800|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71718801|NCT00444925|142952324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0542|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0542
71829409|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.6986|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6986
71718802|NCT00444925|142952325|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0004
71718803|NCT00444925|142952325|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||0.0001
71718804|NCT00444925|142952325|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718805|NCT00444925|142952325|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718806|NCT00444925|142952325|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
71718807|NCT00444925|142952325|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
71718808|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
71718809|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71718810|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5581|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5581
71718811|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71718812|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71718813|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.151|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1510
71718814|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718815|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0001
71718816|NCT00444925|142952326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1391|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1391
71718817|NCT00444925|142952327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71718818|NCT00444925|142952327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.||||<0.0001
71718819|NCT00444925|142952327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718820|NCT00444925|142952327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.||||<0.0001
71718821|NCT00444925|142952327|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||<0.0001
71718822|NCT00444925|142952327|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.||||0.0001
71718823|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
71768613|NCT03836001|143037607|OTHER||Mean Difference (Net)|-0.25||||0.002|TWO_SIDED|95.0|-0.41|-0.09||A p-value of \<0.05 would be considered statistically significant.|Mixed Models Analysis|||Analysis of change from baseline through week 8 including all time points. For this analysis, data were censored at the time of participant discontinuation.||-0.09|-0.41|0.002
71768614|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-5.0|11.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||11.2|-5.0|0.78
71768615|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.75|TWO_SIDED|95.0|-4.6|10.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||10.7|-4.6|0.75
71768616|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.3||0.08|TWO_SIDED|95.0|-0.6|13.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.7|-0.6|0.08
71829410|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.3151|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.3151
71829411|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.1802|ONE_SIDED|95.0|-0.1||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.10|0.1802
71829412|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.9102|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9102
71829413|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.6391|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6391
71829414|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6838|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6838
71829415|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9648|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9648
71887392|NCT02554929|143295649|SUPERIORITY||Mean Difference (Final Values)|1.89|STANDARD_ERROR_OF_MEAN|3.14||0.002|TWO_SIDED|95.0|-4.28|8.08||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.||8.08|-4.28|0.002
71718824|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71718825|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5972|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.5972
71718826|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71718827|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71718828|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.1267|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.1267
71829416|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.8961|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.8961
71829417|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.9534|ONE_SIDED|95.0|-0.41||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.41|0.9534
71829418|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.7726|ONE_SIDED|95.0|-0.45||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.45|0.7726
71829419|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.18||0.5665|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.5665
71829420|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2684|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2684
71887393|NCT01815229|143295686|OTHER||||||<|0.05||||||P value applies to cell count at removal|t-test, 2 sided|||Tracheal lavages (TL) were done in intubated humans to obtain cell counts.||||<0.05
71768617|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4||0.17|TWO_SIDED|95.0|-1.6|13.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on global response."||13.2|-1.6|0.17
71768618|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.7||0.61|TWO_SIDED|95.0|-6.5|17.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||17.2|-6.5|0.61
71768619|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|3.1||0.32|TWO_SIDED|95.0|-4.1|16.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||16.8|-4.1|0.32
71829421|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.6485|ONE_SIDED|95.0|-0.39||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.39|0.6485
71829422|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.4821|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.4821
71829423|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.2557|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2557
71829424|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.9031|ONE_SIDED|95.0|-0.52||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.52|0.9031
71656998|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|-763.6||||0.2702|TWO_SIDED|95.0|-2144.45|617.25||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||617.25|-2144.45|0.2702
71656999|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|947.97||||0.1511|TWO_SIDED|95.0|-361.95|2257.9||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||2257.90|-361.95|0.1511
71657000|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|-270.88||||0.6998|TWO_SIDED|95.0|-1680.58|1138.82||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1138.82|-1680.58|0.6998
71657001|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|-1037.52||||0.121|TWO_SIDED|95.0|-2361.33|286.29||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||286.29|-2361.33|0.1210
71657002|NCT02856880|142831642|SUPERIORITY_OR_OTHER||LS mean difference|-89.54||||0.8935|TWO_SIDED|95.0|-1439.5|1260.41||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.|||1260.41|-1439.50|0.8935
71657003|NCT02944383|142831646|SUPERIORITY||Median Difference (Net)|-19.02||||0.0063|TWO_SIDED|95.0|-33.07|-4.25|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||-4.25|-33.07|0.0063
71657004|NCT02944383|142831646|SUPERIORITY||Median Difference (Net)|-7.63||||0.235|TWO_SIDED|95.0|-25.88|7.05|||Ranked ANCOVA|Randomized treatment group \& randomized baseline statin (yes or no) are included as factors, \& outcome (ranked) at baseline is included as covariate.|Estimates generated from Hodges-Lehmann method.|||7.05|-25.88|0.2350
71657005|NCT02944383|142831647|OTHER|||||||0.1663||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1663
71657006|NCT02944383|142831647|SUPERIORITY|||||||0.6195||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6195
71657007|NCT02944383|142831647|SUPERIORITY|||||||0.0436||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0436
71768620|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|2.8||0.03|TWO_SIDED|95.0|1.6|22.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||22.3|1.6|0.03
71829425|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.8634|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.8634
71829426|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.6375|ONE_SIDED|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.30|0.6375
71657008|NCT02944383|142831647|SUPERIORITY|||||||0.5||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5000
71657009|NCT02944383|142831647|SUPERIORITY|||||||0.0007||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0007
71657010|NCT02944383|142831647|SUPERIORITY|||||||0.1161||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1161
71657011|NCT02944383|142831647|SUPERIORITY|||||||0.183||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1830
71657012|NCT02944383|142831647|SUPERIORITY|||||||0.8762||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8762
71657013|NCT02944383|142831648|SUPERIORITY|||||||0.178||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1780
71657014|NCT02944383|142831648|SUPERIORITY|||||||0.7615||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.7615
71657015|NCT02944383|142831648|SUPERIORITY|||||||0.0162||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0162
71657016|NCT02944383|142831648|SUPERIORITY|||||||0.371||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.3710
71657017|NCT02944383|142831648|SUPERIORITY|||||||0.001||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
71657018|NCT02944383|142831648|SUPERIORITY|||||||0.0988||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0988
71657019|NCT02944383|142831648|SUPERIORITY|||||||0.2594||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2594
71657020|NCT02944383|142831648|SUPERIORITY|||||||0.9099||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9099
71657021|NCT02944383|142831648|SUPERIORITY|||||||0.0219||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0219
71657022|NCT02944383|142831648|SUPERIORITY|||||||0.3494||||||Ranked ANCOVA results are obtained using a model where the outcome is ranked, randomized treatment group and randomized baseline statin (yes or no) are included as factors, and outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3494
71657023|NCT02944383|142831649|SUPERIORITY|||||||0.0391||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0391
71657024|NCT02944383|142831649|SUPERIORITY|||||||0.2455||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2455
71657025|NCT02944383|142831649|SUPERIORITY|||||||0.026||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0260
71829427|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.8775|ONE_SIDED|95.0|-0.51||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.51|0.8775
71829428|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.7191|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.7191
71829429|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.8677|ONE_SIDED|95.0|-0.44||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.44|0.8677
71829430|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.9838|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.9838
71829431|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.8106|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.8106
71829432|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.775|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.7750
71829433|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.8082|ONE_SIDED|95.0|-0.33||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.33|0.8082
71829434|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.7678|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7678
71829435|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.5373|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.5373
71829436|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.9548|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9548
71829437|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9743|ONE_SIDED|95.0|-0.49||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.49|0.9743
71829438|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.8408|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.8408
71829439|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.9887|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9887
71829440|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.13||0.9918|ONE_SIDED|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.55|0.9918
71829441|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.9833|ONE_SIDED|95.0|-0.46||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.46|0.9833
71829442|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.9619|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9619
71829443|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.9917|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.9917
71829444|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.9376|ONE_SIDED|95.0|-0.4||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.40|0.9376
71829445|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.9084|ONE_SIDED|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.47|0.9084
71718829|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718830|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71718831|NCT00444925|142952328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0289|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0289
71718832|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.||||<0.0001
71718833|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.||||<0.0001
71768621|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|3.1||0.04|TWO_SIDED|95.0|0.5|21.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on High Initial NFkB Activation Expressers."||21.8|0.5|0.04
71718834|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.6||0.7288|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7288
71768622|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||1|TWO_SIDED|95.0|-1.5|1.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.2|-1.5|1.00
71768623|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.88|TWO_SIDED|95.0|-3.5|2.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||2.3|-3.5|0.88
71768624|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.98|TWO_SIDED|95.0|-0.8|1.0|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||1.0|-0.8|0.98
71829446|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.15||0.7906|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7906
71718835|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71768625|NCT00899353|143037640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.2||0.98|TWO_SIDED|95.0|-6.6|5.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α\< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."||5.3|-6.6|0.98
71768626|NCT02650921|143037676|SUPERIORITY||Difference in Responder Rate|64.7|||<|0.0001|TWO_SIDED|95.0|53.3|76.1|||McNemar|||||76.1|53.3|<0.0001
71768627|NCT02650921|143037677|SUPERIORITY||Difference in Responder Rate|72.3|||<|0.0001|TWO_SIDED|95.0|61.9|82.7|||McNemar|||||82.7|61.9|<0.0001
71768628|NCT02650921|143037678|SUPERIORITY||Difference in Responder Rate|57.3|||<|0.0001|TWO_SIDED|95.0|44.8|69.8|||McNemar|||||69.8|44.8|<0.0001
71829447|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.8765|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8765
71768629|NCT02650921|143037679|SUPERIORITY||Difference in Responder Rate|45.8|||<|0.0001|TWO_SIDED|95.0|32.3|59.3|||McNemar|||||59.3|32.3|<0.0001
71829448|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.8469|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.8469
71829449|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.9717|ONE_SIDED|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.50|0.9717
71829450|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.7591|ONE_SIDED|95.0|-0.29||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.29|0.7591
71657026|NCT02944383|142831649|SUPERIORITY|||||||0.5704||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.5704
71657027|NCT02944383|142831649|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
71657028|NCT02944383|142831649|SUPERIORITY|||||||0.0846||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0846
71657029|NCT02944383|142831649|SUPERIORITY|||||||0.1763||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1763
71657030|NCT02944383|142831649|SUPERIORITY|||||||0.5576||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5576
71657031|NCT02944383|142831649|SUPERIORITY||Median Difference (Net)|-14.66||||0.0086|TWO_SIDED|95.0|-24.68|-4.39||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.39|-24.68|0.0086
71657032|NCT02944383|142831649|SUPERIORITY||Mean Difference (Net)|-5.06||||0.1516|TWO_SIDED|95.0|-15.02|3.64||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.64|-15.02|0.1516
71657033|NCT02944383|142831650|SUPERIORITY|||||||0.0386||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0386
71657034|NCT02944383|142831650|SUPERIORITY|||||||0.1206||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1206
71657035|NCT02944383|142831650|SUPERIORITY|||||||0.0364||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0364
71657036|NCT02944383|142831650|SUPERIORITY|||||||0.4312||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4312
71657037|NCT02944383|142831650|SUPERIORITY|||||||0.001||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
71657038|NCT02944383|142831650|SUPERIORITY|||||||0.0407||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0407
71657039|NCT02944383|142831650|SUPERIORITY|||||||0.1433||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1433
71657040|NCT02944383|142831650|SUPERIORITY|||||||0.2866||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2866
71657041|NCT02944383|142831650|SUPERIORITY|||||||0.0056||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0056
71657042|NCT02944383|142831650|SUPERIORITY|||||||0.0789||||||Results are obtained using a model where outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0789
71657043|NCT02944383|142831651|SUPERIORITY|||||||0.0277||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0277
71768630|NCT03400956|143037748|SUPERIORITY||Risk Difference (RD)|0.82|||<|0.0001|TWO_SIDED|95.0|0.72|0.93|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 63 (Vilaprisan) / 33 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.93|0.72|<.0001
71718836|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71718837|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2473|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.2473
71718838|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718839|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.||||<0.0001
71718840|NCT00444925|142952329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1047|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.1047
71718841|NCT00444925|142952330|SUPERIORITY_OR_OTHER|||||||0.0143||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0143
71718842|NCT00444925|142952330|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||<0.0001
71718843|NCT00444925|142952330|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||<0.0001
71718844|NCT00444925|142952331|SUPERIORITY_OR_OTHER|||||||0.0773||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1||||0.0773
71718845|NCT00444925|142952331|SUPERIORITY_OR_OTHER|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4||||0.0017
71718846|NCT00444925|142952331|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12||||0.0008
71718847|NCT00444925|142952332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment difference Fesoterodine vs placebo at Week 12||||<0.0001
71718848|NCT00444925|142952333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||||<0.0001
71718849|NCT00444925|142952333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||||<0.0001
71718850|NCT00444925|142952333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|1.5||0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||||0.0008
71718851|NCT00444925|142952333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||||<0.0001
71768631|NCT03044574|143037757|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71768632|NCT03044574|143037758|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71768633|NCT03044574|143037759|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71768634|NCT03044574|143037760|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71768635|NCT03044574|143037761|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71768636|NCT03044574|143037762|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71768637|NCT03044574|143037763|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71768638|NCT03044574|143037765|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71768639|NCT01402427|143037768|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.28|TWO_SIDED|95.0|-0.011|0.033|||Fisher Exact|||||0.033|-0.011|0.28
71768640|NCT01402427|143037769|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
71768641|NCT01402427|143037770|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71768642|NCT01402427|143037771|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71768643|NCT01402427|143037772|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
71768644|NCT01402427|143037773|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71718852|NCT00444925|142952333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||||<0.0001
71718853|NCT00444925|142952334|SUPERIORITY_OR_OTHER|||||||0.0072||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 1.||||0.0072
71887394|NCT03569202|143295717|SUPERIORITY||Mean Difference (Final Values)|1.8837||||0.662|TWO_SIDED|95.0|-6.7081|10.4756||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||10.4756|-6.7081|0.662
71718854|NCT00444925|142952334|SUPERIORITY_OR_OTHER|||||||0.0116||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1.||||0.0116
71718855|NCT00444925|142952334|SUPERIORITY_OR_OTHER|||||||0.7828||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.||||0.7828
71718856|NCT00444925|142952334|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 4.||||<0.0001
71718857|NCT00444925|142952334|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4.||||<0.0001
71718858|NCT00444925|142952334|SUPERIORITY_OR_OTHER|||||||0.3104||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.||||0.3104
71718859|NCT00444925|142952334|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 12.||||<0.0001
71718860|NCT00444925|142952334|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12.||||0.0004
71718861|NCT00444925|142952334|SUPERIORITY_OR_OTHER|||||||0.0153||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.||||0.0153
71718862|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|90.0|-0.57|0.43|||||6 months visit|||0.43|-0.57|
71718863|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.31|0.71|||||12 months visit|||0.71|-0.31|
71718864|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.33|0.68|||||18 months visit|||0.68|-0.33|
71718865|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|90.0|-0.71|0.26|||||6 months visit|||0.26|-0.71|
71718866|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.26|0.72|||||12 months visit|||0.72|-0.26|
71718867|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.21|0.77|||||18 months visit|||0.77|-0.21|
71718868|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.66|0.29|||||6 months visit|||0.29|-0.66|
71718869|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.19|0.75|||||12 months visit|||0.75|-0.19|
71718870|NCT01342926|142952375|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.08|0.86|||||18 months visit|||0.86|-0.08|
71718871|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|90.0|-0.34|0.61|||||6 months visit|||0.61|-0.34|
71718872|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|||||TWO_SIDED|90.0|-0.07|0.89|||||12 months visit|||0.89|-0.07|
71718873|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|90.0|-0.06|0.89|||||18 months visit|||0.89|-0.06|
71718874|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|90.0|-0.55|0.37|||||6 months visit|||0.37|-0.55|
71718875|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.13|0.8|||||12 months visit|||0.80|-0.13|
71718876|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|90.0|-0.3|0.63|||||18 months visit|||0.63|-0.30|
71718877|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.31|0.57|||||6 months visit|||0.57|-0.31|
71718878|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|90.0|0.1|0.99|||||12 months visit|||0.99|0.10|
71718879|NCT01342926|142952383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||||TWO_SIDED|90.0|0.47|1.36|||||18 months visit|||1.36|0.47|
71718880|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.34|0.55|||||6 months visit|||0.55|-0.34|
71718881|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.0|0.9|||||12 months visit|||0.90|0.00|
71718882|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.12|0.77|||||18 months visit|||0.77|-0.12|
71718883|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|90.0|-0.51|0.35|||||6 months visit|||0.35|-0.51|
71718884|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|90.0|-0.21|0.66|||||12 months visit|||0.66|-0.21|
71718885|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.32|0.55|||||18 months visit|||0.55|-0.32|
71718886|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.48|0.35|||||6 months visit|||0.35|-0.48|
71718887|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|90.0|-0.22|0.62|||||12 months visit|||0.62|-0.22|
71887395|NCT03569202|143295717|OTHER||Mean Difference (Final Values)|-24.6445|||<|0.0001|TWO_SIDED|95.0|-30.7199|-18.5692||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-18.5692|-30.7199|<0.0001
71887396|NCT03569202|143295717|OTHER||Mean Difference (Final Values)|-26.5283|||<|0.0001|TWO_SIDED|95.0|-32.6036|-20.4529||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-20.4529|-32.6036|<0.0001
71887397|NCT03569202|143295718|OTHER||Mean Difference (Final Values)|-2.9808||||0.575|TWO_SIDED|95.0|-13.6005|7.639||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.6390|-13.6005|0.575
71887398|NCT03569202|143295718|OTHER||Mean Difference (Final Values)|-4.75||||0.2098|TWO_SIDED|95.0|-12.2593|2.7593||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7593|-12.2593|0.2098
71887399|NCT03569202|143295718|OTHER||Mean Difference (Final Values)|-1.7692||||0.6381|TWO_SIDED|95.0|-9.2785|5.7401||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||5.7401|-9.2785|0.6381
71887400|NCT03569202|143295719|OTHER||Mean Difference (Final Values)|0.8462||||0.271|TWO_SIDED|95.0|-0.6792|2.3715||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||2.3715|-0.6792|0.271
71887401|NCT03569202|143295719|OTHER||Mean Difference (Final Values)|1.7115||||0.0025|TWO_SIDED|95.0|0.633|2.7901||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||2.7901|0.6330|0.0025
71887402|NCT03569202|143295719|OTHER||Mean Difference (Final Values)|0.8654||||0.1134|TWO_SIDED|95.0|-0.2132|1.944||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.9440|-0.2132|0.1134
71718888|NCT01342926|142952384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|90.0|0.08|0.92|||||18 months visit|||0.92|0.08|
71718889|NCT03382912|142952393|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.3|5.9|||||Odds Ratio stratified based on tumor histology at randomization (interactive web response system (IWRS)), smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||5.9|0.3|
71718890|NCT03382912|142952394|SUPERIORITY||Hazard Ratio (HR)|1.006|||||TWO_SIDED|95.0|0.519|1.951|||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (interactive web response system (IWRS)) and smoking status (IWRS).|||1.951|0.519|
71718891|NCT03382912|142952395|SUPERIORITY||Hazard Ratio (HR)|1.871|||||TWO_SIDED|95.0|0.772|4.532|||||||The estimate of the hazard ration (HR) stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS).|4.532|0.772|
71768645|NCT01402427|143037774|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
71718892|NCT03382912|142952396|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.4|4.1|||||Odds Ratio stratified based on tumor histology at randomization (IWRS) and smoking status (IWRS). Confidence intervals were based on the Clopper-Pearson method.|||4.1|0.4|
71768646|NCT04355728|143037776|SUPERIORITY|||||||0.04|||||||Fisher Exact|||"The null hypothesis is the following: There is no difference in the number of subjects experiencing serious adverse events in the UC-MSC vs control group."||||.04
71768647|NCT04355728|143037785|SUPERIORITY||Hazard Ratio (HR)|0.289||||0.0307|TWO_SIDED|95.0|0.088|0.948|||Log Rank||Censoring was limited to dropout from study, and the event of interest was recovery. In the case of death, the patient's time to recovery was censored at the end of study observation; thus the patient remained in the risk set for all KM estimations.|"The null hypothesis is the following: There is no difference in Time to Recovery up to 31 days post infusion between the UC-MSC group and control group. Time to recovery was estimated in each group with Kaplan-Meier survival estimates. Log-rank tests were used to compare hazards between groups."||0.948|0.088|0.0307
71768648|NCT04355728|143037786|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
71768649|NCT04355728|143037787|SUPERIORITY|||||||0.0563|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: The center of the distributions of ventilator free days are equal in the UC-MSC and control group.||||.0563
71768650|NCT04355728|143037818|SUPERIORITY|||||||0.0356|||||||Wilcoxon (Mann-Whitney)|||||||0.0356
71768651|NCT04355728|143037819|SUPERIORITY|||||||0.0215|||||||Wilcoxon (Mann-Whitney)|||||||0.0215
71768652|NCT04355728|143037820|SUPERIORITY||Mean Difference (Net)|-3498.0|STANDARD_DEVIATION|3078.2||0.021|TWO_SIDED|95.0|-6404.7|-591.2|||t-test, 2 sided|||||-591.2|-6404.7|0.0210
71768653|NCT04355728|143037822|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 3 days post first infusion."||||0.48
71887403|NCT03569202|143295720|OTHER||Mean Difference (Final Values)|2.1731||||0.412|TWO_SIDED|95.0|-3.1016|7.4477||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||7.4477|-3.1016|0.412
71887404|NCT03569202|143295720|OTHER||Mean Difference (Final Values)|0.01923||||0.9918|TWO_SIDED|95.0|-3.7105|3.749||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||3.7490|-3.7105|0.9918
71887405|NCT03569202|143295720|OTHER||Mean Difference (Final Values)|-2.1538||||0.2516|TWO_SIDED|95.0|-5.8836|1.5759||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||1.5759|-5.8836|0.2516
71887406|NCT03569202|143295721|OTHER||Mean Difference (Final Values)|0.5093||||0.047|TWO_SIDED|95.0|0.007267|1.0113||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||1.0113|0.007267|0.047
71887407|NCT03569202|143295721|OTHER||Mean Difference (Final Values)|0.5596||||0.0026|TWO_SIDED|95.0|0.2046|0.9146||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.9146|0.2046|0.0026
71887408|NCT03569202|143295721|OTHER||Mean Difference (Final Values)|0.05032||||0.777|TWO_SIDED|95.0|-0.3047|0.4053||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||0.4053|-0.3047|0.7770
71887409|NCT03569202|143295722|OTHER||Wilcoxon Z statistic|-0.7604||||0.447|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.447
71887410|NCT03569202|143295722|OTHER|||||||0.014||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.014
71887411|NCT03569202|143295722|OTHER|||||||0.07||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.070
71887412|NCT03569202|143295723|OTHER||Wilcoxon Z statistic|-0.6396||||0.522|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.522
71887413|NCT03569202|143295723|OTHER|||||||0.119||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.119
71887414|NCT03569202|143295723|OTHER|||||||0.9||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.900
71887415|NCT03569202|143295724|OTHER||Wilcoxon Z statistic|-0.5387||||0.59|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.590
71657044|NCT02944383|142831651|SUPERIORITY|||||||0.2502||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2502
71657045|NCT02944383|142831651|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0161
71657046|NCT02944383|142831651|SUPERIORITY|||||||0.6567||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6567
71657047|NCT02944383|142831651|SUPERIORITY|||||||0.001||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0010
71657048|NCT02944383|142831651|SUPERIORITY|||||||0.1257||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1257
71657049|NCT02944383|142831651|SUPERIORITY|||||||0.144||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1440
71657050|NCT02944383|142831651|SUPERIORITY|||||||0.7642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7642
71657051|NCT02944383|142831651|SUPERIORITY||Median Difference (Net)|-16.4||||0.0107|TWO_SIDED|95.0|-28.31|-4.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-4.51|-28.31|0.0107
71657052|NCT02944383|142831651|SUPERIORITY||Median Difference (Net)|-5.32||||0.2466|TWO_SIDED|95.0|-16.73|5.52||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.52|-16.73|0.2466
71657053|NCT02944383|142831652|SUPERIORITY|||||||0.0211||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.0211
71657054|NCT02944383|142831652|SUPERIORITY|||||||0.1304||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1304
71657055|NCT02944383|142831652|SUPERIORITY|||||||0.0318||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.0318
71657056|NCT02944383|142831652|SUPERIORITY|||||||0.4607||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.4607
71657057|NCT02944383|142831652|SUPERIORITY|||||||0.0012||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0012
71657058|NCT02944383|142831652|SUPERIORITY|||||||0.0592||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0592
71657059|NCT02944383|142831652|SUPERIORITY|||||||0.117||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1170
71657060|NCT02944383|142831652|SUPERIORITY|||||||0.3138||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3138
71657061|NCT02944383|142831652|SUPERIORITY|||||||0.009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0090
71657062|NCT02944383|142831652|SUPERIORITY|||||||0.1317||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1317
71718893|NCT00707993|142952426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||ONE_SIDED|97.5||0.13|||ANCOVA|Treatment, randomization schedule, and geographic region as class effects; baseline value for the endpoint as a continuous covariate.||Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI \[alpha=0.025\] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was \< 0%.||0.13||
71718894|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 5.||||=0.029
71718895|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.027|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 11.||||=0.027
71718896|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.602|TWO_SIDED||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at end of FU.||||=0.602
71718897|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.631|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 5.||||=0.631
71718898|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.339|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 11.||||=0.339
71718899|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.44|TWO_SIDED||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at end of FU.||||=0.440
71718900|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 5.||||=1.000
71718901|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.465|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 11.||||=0.465
71887416|NCT03569202|143295724|OTHER|||||||0.043||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.043
71718902|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.431|TWO_SIDED||||||t-test, 2 sided|||CFB in role functioning statistical analysis at end of FU.||||=0.431
71718903|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.65|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 5.||||=0.650
71718904|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.98|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 11.||||=0.980
71718905|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.906|TWO_SIDED||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at end of FU.||||=0.906
71718906|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.381|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 5.||||=0.381
71768654|NCT04355728|143037822|SUPERIORITY|||||||0.41|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 3 days post first infusion."||||0.41
71768655|NCT04355728|143037823|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 6 days post first infusion."||||1.00
71768656|NCT04355728|143037823|SUPERIORITY|||||||1|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (Class II) status and treatment group at 6 days post first infusion."||||1.00
71768657|NCT04355728|143037824|SUPERIORITY|||||||0.44|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class I) status and treatment group at 14 days post first infusion."||||0.44
71768658|NCT04355728|143037824|SUPERIORITY|||||||0.5238|||||||Fisher Exact|||"The null hypothesis is the following: There is no association between PRA (class II) status and treatment group at 14 days post first infusion."||||0.5238
71718907|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.886|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 11.||||=0.886
71718908|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.264|TWO_SIDED||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at end of FU.||||=0.264
71718909|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.424|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 5.||||=0.424
71718910|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 11.||||=1.000
71718911|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.312|TWO_SIDED||||||t-test, 2 sided|||CFB in social functioning statistical analysis at end of FU.||||=0.312
71718912|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.664|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at Cycle 5.||||=0.664
71718913|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue functioning statistical analysis at Cycle 11.||||=0.170
71718914|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.318|TWO_SIDED||||||t-test, 2 sided|||CFB in fatigue statistical analysis at end of FU.||||=0.318
71718915|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.536|TWO_SIDED||||||t-test, 2 sided|||CFB in Nausea/vomiting statistical analysis at Cycle 5.||||=0.536
71718916|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.9|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at Cycle 11.||||=0.900
71718917|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.188|TWO_SIDED||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at end of FU.||||=0.188
71718918|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.37|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 5.||||=0.370
71718919|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|0.813|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 11.||||=0.813
71718920|NCT00532129|142952474|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||t-test, 2 sided|||CFB in pain statistical analysis at end of FU.||||=1.000
71718921|NCT03427814|142952488|SUPERIORITY||||||=|0.1428|||||||Log Rank|The one-sided p-value was based on a stratified log-rank test.||||||= 0.1428
71718922|NCT03846427|142952501|SUPERIORITY|P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%|||||<|0.0001|||||||Binomial exact method|||||||<0.0001
71768659|NCT00608569|143037860|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Results were considered to be statistically significant if p\<0.05|Fisher Exact|||Fisher exact test (unstratified)||||0.133
71887417|NCT03569202|143295724|OTHER|||||||0.442||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.442
71718923|NCT01693250|142952527|SUPERIORITY||Mean Difference (Final Values)|1.68|STANDARD_DEVIATION|0.5|<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.||||<.001
71718924|NCT01693250|142952528|SUPERIORITY||Mean Difference (Final Values)|2.66||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.||||.001
71718925|NCT04971967|142952561|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
71718926|NCT04971967|142952562|SUPERIORITY|||||||0.3|||||||Generalized linear regression|||||||0.30
71718927|NCT04971967|142952564|SUPERIORITY|||||||0.28|||||||Generalized linear regression|||||||0.28
71718928|NCT04971967|142952566|SUPERIORITY|||||||0.07|||||||Generalized linear regression|||||||0.07
71718929|NCT04971967|142952567|SUPERIORITY|||||||0.11|||||||Generalized linear regression|||||||0.11
71718930|NCT04723355|142952649|NON_INFERIORITY|In the sample size calculations, we assumed that the innovative 3-lead wireless water resistant Holter System would have a concordance in the diagnosis of arrhythmia compared to the conventional Holter device similar to a previous study that compared a patch to the conventional Holter device. With this assumption, a total sample of 182 participants would have 80% power to demonstrate an accuracy of at least 85% with a significance level of 2.5% (the 95% CI lower limit should be above 85%).|Accuracy|0.87|||||TWO_SIDED|95.0|0.81|0.92||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.92|0.81|
71768660|NCT03445156|143037880|OTHER|ANCOVA||||||0.04|||||||ANCOVA|F(2, 273) = 3.16, p = .044, partial c\^2 = .023||||||0.04
71768661|NCT03445156|143037880|OTHER|ANCOVA||||||0.0001|||||||ANCOVA|F(1, 36) = 44.42||||||.0001
71768662|NCT03445156|143037881|OTHER|ANCOVA|||||<|0.001|||||||ANCOVA|F(1, 36) = 44.42||Hypothesis: Participants who played a violent FPS game were expected to have more hits to targets with heads or faces than were participants who played a nonviolent shooting game.||||<.001
71768663|NCT03445156|143037881|OTHER|ANCOVA||||||0.044|||||||ANCOVA|F(2, 273) = 3.16||Hypothesis: Participants who played a violent FPS game were expected to hit the mannequin's head more often than were participants who played either the nonviolent shooting game or the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.044
71768664|NCT03445156|143037881|OTHER|ANCOVA||||||0.17|||||||t-test, 2 sided|t(274) = 2.40||"Hypothesis: Because the nonviolent shooting game rewards other shots, participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||0.17
71718931|NCT04723355|142952649|OTHER||Sensitivity|0.9|||||TWO_SIDED|95.0|0.83|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.83|
71718932|NCT04723355|142952649|OTHER||Specificity|0.83|||||TWO_SIDED|95.0|0.72|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.72|
71768665|NCT03445156|143037881|OTHER|ANCOVA||||||0.449|||||||t-test, 2 sided|t(274) = -0.76||Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's head less often than were participants who played the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.||||.449
71887418|NCT03569202|143295726|OTHER||Wilcoxon Z statistic|0.9208||||0.357|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.357
71718933|NCT04723355|142952649|OTHER||Positive predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
71718934|NCT04723355|142952649|OTHER||Negative predictive value|0.86|||||TWO_SIDED|95.0|0.76|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.76|
71768666|NCT03445156|143037881|OTHER|ANCOVA||||||0.645|||||||t-test, 2 sided|t(273) = -0.46||"Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin's torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."||||.645
71887419|NCT03569202|143295726|OTHER|||||||0.001||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.001
71718935|NCT04723355|142952649|OTHER||Cohen Kappa coefficient|0.74|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71718936|NCT04723355|142952649|OTHER||Positive likelihood ratio|5.21|||||TWO_SIDED|95.0|3.17|8.58||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||8.58|3.17|
71718937|NCT04723355|142952649|OTHER||Negative likelihood ratio|0.12|||||TWO_SIDED|95.0|0.06|0.21||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.21|0.06|
71718938|NCT04723355|142952650|OTHER||Accuracy|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.97|
71718939|NCT04723355|142952650|OTHER||Sensitivity|1.0|||||TWO_SIDED|95.0|0.85|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.85|
71718940|NCT04723355|142952650|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
71718941|NCT04723355|142952650|OTHER||Positive predictive value|0.96|||||TWO_SIDED|95.0|0.78|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.78|
71718942|NCT04723355|142952650|OTHER||Negative predictive value|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
71718943|NCT04723355|142952650|OTHER||Cohen Kappa coefficient|0.97|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71718944|NCT04723355|142952650|OTHER||Positive likelihood ratio|157.0|||||TWO_SIDED|95.0|22.25|1107.61||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1107.61|22.25|
71718945|NCT04723355|142952650|OTHER||Negative likelihood ratio|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0|0|
71718946|NCT04723355|142952651|OTHER||Accuracy|0.85|||||TWO_SIDED|95.0|0.79|0.9||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.90|0.79|
71718947|NCT04723355|142952651|OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
71718948|NCT04723355|142952651|OTHER||Specificity|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
71887420|NCT03569202|143295726|OTHER|||||||0.065||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.065
71718949|NCT04723355|142952651|OTHER||Positive predictive value|0.82|||||TWO_SIDED|95.0|0.71|0.9||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.90|0.71|
71718950|NCT04723355|142952651|OTHER||Negative predictive value|0.88|||||TWO_SIDED|95.0|0.8|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.80|
71718951|NCT04723355|142952651|OTHER||Cohen Kappa coefficient|0.7|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71718952|NCT04723355|142952651|OTHER||Positive likelihood ratio|6.79|||||TWO_SIDED|95.0|4.03|11.43||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||11.43|4.03|
71718953|NCT04723355|142952651|OTHER||Negative likelihood ratio|0.21|||||TWO_SIDED|95.0|0.13|0.34||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.34|0.13|
71718954|NCT04723355|142952652|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.88|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.88|
71718955|NCT04723355|142952652|OTHER||Sensitivity|0.78|||||TWO_SIDED|95.0|0.56|0.93||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.93|0.56|
71718956|NCT04723355|142952652|OTHER||Specificity|0.95|||||TWO_SIDED|95.0|0.9|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.90|
71718957|NCT04723355|142952652|OTHER||Positive predictive value|0.69|||||TWO_SIDED|95.0|0.48|0.86||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.86|0.48|
71718958|NCT04723355|142952652|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
71718959|NCT04723355|142952652|OTHER||Cohen Kappa coefficient|0.69|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71887421|NCT03569202|143295727|OTHER||Wilcoxon Z statistic|1.044||||0.296|TWO_SIDED|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline||||0.296
71887422|NCT03569202|143295727|OTHER|||||||0.012||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||0.012
71718960|NCT04723355|142952652|OTHER||Positive likelihood ratio|15.26|||||TWO_SIDED|95.0|7.51|30.99||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||30.99|7.51|
71718961|NCT04723355|142952652|OTHER||Negative likelihood ratio|0.23|||||TWO_SIDED|95.0|0.11|0.5||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.50|0.11|
71718962|NCT04723355|142952653|OTHER||Accuracy|0.93|||||TWO_SIDED|95.0|0.89|0.96||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.96|0.89|
71718963|NCT04723355|142952653|OTHER||Sensitivity|0.58|||||TWO_SIDED|95.0|0.28|0.85||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.85|0.28|
71718964|NCT04723355|142952653|OTHER||Specificity|0.96|||||TWO_SIDED|95.0|0.92|0.98||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.98|0.92|
71718965|NCT04723355|142952653|OTHER||Positive predictive value|0.5|||||TWO_SIDED|95.0|0.23|0.77||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.77|0.23|
71718966|NCT04723355|142952653|OTHER||Negative predictive value|0.97|||||TWO_SIDED|95.0|0.93|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.93|
71718967|NCT04723355|142952653|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71718968|NCT04723355|142952653|OTHER||Positive likelihood ratio|13.92|||||TWO_SIDED|95.0|5.84|33.17||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||33.17|5.84|
71718969|NCT04723355|142952653|OTHER||Negative likelihood ratio|0.43|||||TWO_SIDED|95.0|0.22|0.85||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.85|0.22|
71718970|NCT04723355|142952654|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.95|1.0||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||1.00|0.95|
71718971|NCT04723355|142952654|OTHER||Sensitivity|0.75|||||TWO_SIDED|95.0|0.19|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.19|
71718972|NCT04723355|142952654|OTHER||Specificity|0.99|||||TWO_SIDED|95.0|0.96|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.96|
71718973|NCT04723355|142952654|OTHER||Positive predictive value|0.6|||||TWO_SIDED|95.0|0.15|0.95||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.95|0.15|
71718974|NCT04723355|142952654|OTHER||Negative predictive value|0.99|||||TWO_SIDED|95.0|0.97|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.97|
71718975|NCT04723355|142952654|OTHER||Cohen Kappa coefficient|0.66|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71718976|NCT04723355|142952654|OTHER||Positive likelihood ratio|65.63|||||TWO_SIDED|95.0|14.8|291.07||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||291.07|14.80|
71887423|NCT03569202|143295727|OTHER||||||>|0.05||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline||||>0.05
71718977|NCT04723355|142952654|OTHER||Negative likelihood ratio|0.25|||||TWO_SIDED|95.0|0.05|1.38||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||1.38|0.05|
71718978|NCT04723355|142952655|OTHER||Accuracy|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||The comparison of the two Holter monitoring devices was analyzed in terms of the accuracy of the Innovative 3-lead Wireless Water Resistant Holter System in detecting the arrhythmias compared to the Conventional Holter System as the gold standard.||0.99|0.94|
71718979|NCT04723355|142952655|OTHER||Sensitivity|0.64|||||TWO_SIDED|95.0|0.31|0.89||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.89|0.31|
71718980|NCT04723355|142952655|OTHER||Specificity|1.0|||||TWO_SIDED|95.0|0.98|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.98|
71718981|NCT04723355|142952655|OTHER||Positive predictive value|1.0|||||TWO_SIDED|95.0|0.59|1.0||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||1.00|0.59|
71718982|NCT04723355|142952655|OTHER||Negative predictive value|0.98|||||TWO_SIDED|95.0|0.94|0.99||||||Other measures of diagnostic accuracy, including the sensitivity, specificity, positive and negative predictive values were also analyzed.||0.99|0.94|
71718983|NCT04723355|142952655|OTHER||Cohen Kappa coefficient|0.77|||||TWO_SIDED|||||||||We also did an additional analysis to further evaluate the concordance between both Holter monitoring devices using the Cohen´s Kappa coefficient.||||
71718984|NCT04723355|142952655|OTHER|||||||||||||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.|The positive likelihood ratio could not be calculated due to the value of zero in the denominator|||
71718985|NCT04723355|142952655|OTHER||Negative likelihood ratio|0.36|||||TWO_SIDED|95.0|0.17|0.79||||||Exploratory analyses of positive and negative likelihood ratios were also conducted.||0.79|0.17|
71718986|NCT04723355|142952657|OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-6.2|4.31||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||4.31|-6.20|
71718987|NCT04723355|142952657|OTHER||Lin´s concordance correlation coeficient|0.97|||||TWO_SIDED|95.0|0.96|0.98||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.98|0.96|
71718988|NCT04723355|142952658|OTHER||Mean Difference (Final Values)|-2.71|||||TWO_SIDED|95.0|-17.09|11.67||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||11.67|-17.09|
71718989|NCT04723355|142952658|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
71718990|NCT04723355|142952659|OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|95.0|-5.43|6.22||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||6.22|-5.43|
71718991|NCT04723355|142952659|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.93|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.93|
71718992|NCT04723355|142952660|OTHER||Mean Difference (Final Values)|-6.37|||||TWO_SIDED|95.0|-1391.46|1378.72||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1378.72|-1391.46|
71718993|NCT04723355|142952660|OTHER||Lin´s concordance correlation coeficient|0.95|||||TWO_SIDED|95.0|0.94|0.96||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.96|0.94|
71718994|NCT04723355|142952661|OTHER||Mean Difference (Final Values)|11.04|||||TWO_SIDED|95.0|-2089.58|2111.65||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||2111.65|-2089.58|
71718995|NCT04723355|142952661|OTHER||Lin´s concordance correlation coeficient|0.92|||||TWO_SIDED|95.0|0.89|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.89|
71718996|NCT04723355|142952662|OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-5.45|5.2||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||5.20|-5.45|
71718997|NCT04723355|142952662|OTHER||Lin´s concordance correlation coeficient|0.93|||||TWO_SIDED|95.0|0.91|0.94||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.94|0.91|
71718998|NCT04723355|142952663|OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-13.38|12.07||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||12.07|-13.38|
71718999|NCT04723355|142952663|OTHER||Lin´s concordance correlation coeficient|0.987|||||TWO_SIDED|95.0|0.98|0.99||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.99|0.98|
71719000|NCT04723355|142952664|OTHER||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.75|1.56||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||1.56|-1.75|
71719001|NCT04723355|142952664|OTHER||Lin´s concordance correlation coeficient|0.9976|||||TWO_SIDED|95.0|0.997|0.998||||||The quantitative secondary outcomes were analyzed using Bland-Altman graphs as well as the Lin´s concordance correlation coefficient (CCC).||0.998|0.997|
71719002|NCT04723355|142952665|SUPERIORITY||chi-squared test statistic|23.529|||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71719003|NCT01109108|142952666|OTHER||Risk Ratio (RR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71768667|NCT03445156|143037881|OTHER|Zero-order correlation||||||0.032|||||||Zero-order correlation|||Hypothesis: A positive correlation was expected between the number of violent shooting games participants listed among their three favorite video games and hits to the mannequin's head.||||.032
71887424|NCT03569202|143295729|OTHER||Mean Difference (Final Values)|-1.9911||||0.764|TWO_SIDED|95.0|-15.6117|11.6295||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline||11.6295|-15.6117|0.764
71719004|NCT01516632|142952690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.82|3.21||||||||3.21|.82|
71719005|NCT01516632|142952691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.22|5.3||||||||5.30|1.22|
71768668|NCT03874429|143037915|NON_INFERIORITY|Non- inferiority was demonstrated if the upper bound of the 95% CI was no higher than 2 points for the the difference of T2259 minus Vismed Multi.|Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.42|1.05|||ANCOVA|||To assess the non inferiority of T2259 compared to Vismed Multi, two-sided 95% confidence interval from ANCOVA model was computed of the difference of T2259 minus Vismed Multi. The model was adjusted for the main effects of investigation product and baseline score.||1.05|-0.42|
71719006|NCT01516632|142952692|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||||TWO_SIDED|95.0|1.48|7.45||||||||7.45|1.48|
71719007|NCT00348946|142952703|SUPERIORITY|BOT Visual-motor control||||||0.005|||||||ANCOVA|||||||0.005
71719008|NCT00348946|142952703|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT upper limb speed||||0.17
71719009|NCT00348946|142952703|SUPERIORITY|||||||0.17|||||||ANCOVA|||BOT strength||||0.17
71719010|NCT00348946|142952703|SUPERIORITY|||||||0.06|||||||ANCOVA|||Hand dynamometer||||0.06
71719011|NCT00348946|142952703|SUPERIORITY|||||||0.87|||||||ANCOVA|||PANESS||||0.87
71719012|NCT00348946|142952704|SUPERIORITY|||||||0.44|||||||ANCOVA|||DAS: General concept ability||||0.44
71719013|NCT00348946|142952704|SUPERIORITY|||||||0.57|||||||ANCOVA|||DAS: Verbal Cluster||||0.57
71719014|NCT00348946|142952704|SUPERIORITY|||||||0.55|||||||ANCOVA|||DAS: Nonverbal Cluster||||0.55
71719015|NCT00348946|142952704|SUPERIORITY|||||||0.65|||||||ANCOVA|||DAS: Spatial Cluster||||0.65
71719016|NCT00348946|142952705|SUPERIORITY|||||||0.23|||||||ANCOVA|||Digit Span backward||||0.23
71719017|NCT00348946|142952705|SUPERIORITY|||||||0.36|||||||ANCOVA|||Phonetic fluency||||0.36
71719018|NCT00348946|142952705|SUPERIORITY|||||||0.37|||||||ANCOVA|||Semantic fluency||||0.37
71719019|NCT00348946|142952705|SUPERIORITY|||||||0.41|||||||ANCOVA|||CPT: omissions||||0.41
71719020|NCT00348946|142952705|SUPERIORITY|||||||0.73|||||||ANCOVA|||CPT: commissions||||0.73
71719021|NCT00348946|142952705|SUPERIORITY|||||||0.4|||||||ANCOVA|||CPT: hit reaction time||||0.40
71719022|NCT00348946|142952705|SUPERIORITY|||||||0.95|||||||ANCOVA|||CPT: variability||||0.95
71719023|NCT00348946|142952705|SUPERIORITY|||||||0.78|||||||ANCOVA|||CPT: preservations||||0.78
71719024|NCT00348946|142952706|SUPERIORITY|||||||0.16|||||||ANCOVA|||CBCL: Behavior total||||0.16
71719025|NCT00348946|142952706|SUPERIORITY|||||||0.1|||||||ANCOVA|||CBCL: Internalizing total||||0.10
71719026|NCT00348946|142952706|SUPERIORITY|||||||0.24|||||||ANCOVA|||CBCL: externalizing total||||0.24
71719027|NCT00348946|142952706|SUPERIORITY|||||||0.5|||||||ANCOVA|||CDI: Total||||0.50
71719028|NCT00348946|142952707|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
71719029|NCT02820844|142952737|OTHER||Mean Difference (Net)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.14|-1.18||Analysis was performed using mixed-model for repeated measures (MMRM) with treatment, site, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||-1.18|-3.14|<0.001
71719030|NCT02820844|142952738|OTHER||Mean Difference (Net)|29.69|||<|0.001|TWO_SIDED|95.0|18.47|40.91||Analysis performed using MMRM, with treatment, site, visit, Baseline urinary urgency incontinence (UUI) episodes over 3 day diary (\<=9 or \>=10), treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.|||40.91|18.47|<0.001
71719031|NCT02820844|142952793|OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10).|Log Rank||Hazard ratio and 95% Confidence Interval (CI) are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.60|0.34|<0.001
71719032|NCT02820844|142952794|OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.66||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10)|Log Rank||Hazard ratio and 95% CI are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (\<=9 versus \>=10) as fixed effect.|||0.66|0.38|<0.001
71719033|NCT02266147|142952856|OTHER|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.||||||||||||||||MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.|||
71719034|NCT01896687|142952862|SUPERIORITY_OR_OTHER||||||<|0.001||||||"The worst pain and interference scores as dependent variables, and time (baseline, 1-, and 3 week follow up visit), group (Calmare or Sham), and group by time interaction terms as the independent variable."|ANOVA|||||||<0.001
71719035|NCT02831855|142952894|NON_INFERIORITY|Non-inferiority (NI) of Tofacitinib 11 mg + Methotrexate Placebo to Tofacitinib 11 mg + continued Methotrexate was concluded if the upper bound of 95% 2-sided confidence interval (CI) for difference between the 2 arms (Tofacitinib 11 mg + Methotrexate Placebo reporting arm - Tofacitinib 11 mg + continued Methotrexate arm) was lower than 0.6.|Least Square (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|0.12|0.48||The p-value is one-sided for the test against the NI margin of 0.6.|MMRM|||Linear mixed-effect model of repeated measures (MMRM) was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (bDMARD), and baseline DAS28-4 (ESR) value as a covariate.||0.48|0.12|0.0005
71719036|NCT02831855|142952895|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.03|0.41||||||Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (ESR) value as a covariate.||0.41|0.03|
71719037|NCT02831855|142952896|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.08|0.43||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.43|0.08|
71719038|NCT02831855|142952896|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.11|0.45||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.||0.45|0.11|
71719039|NCT02831855|142952897|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.4|3.07||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.07|0.40|
71719040|NCT02831855|142952897|SUPERIORITY||LS Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|0.83|3.43||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.||3.43|0.83|
71719041|NCT02831855|142952898|SUPERIORITY||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|0.53|3.37||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.37|0.53|
71719042|NCT02831855|142952898|SUPERIORITY||LS Mean Difference|2.23|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|0.86|3.59||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.||3.59|0.86|
71719043|NCT02831855|142952899|SUPERIORITY||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.15|2.76||||||Week 36||2.76|-14.15|
71719044|NCT02831855|142952899|SUPERIORITY||Difference in percentage of participants|-4.54|||||TWO_SIDED|95.0|-13.04|3.94||||||Week 48||3.94|-13.04|
71719045|NCT02831855|142952900|SUPERIORITY||Difference in percentage of participants|-5.14|||||TWO_SIDED|95.0|-13.07|2.77||||||Week 36||2.77|-13.07|
71719046|NCT02831855|142952900|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-16.28|-0.76||||||Week 48||-0.76|-16.28|
71657063|NCT02944383|142831653|SUPERIORITY|||||||0.2395||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.2395
71719047|NCT02831855|142952901|SUPERIORITY||Difference in percentage of participants|-7.39|||||TWO_SIDED|95.0|-15.17|0.38||||||Week 36||0.38|-15.17|
71829451|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.7141|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7141
71719048|NCT02831855|142952901|SUPERIORITY||Difference in percentage of participants|-11.91|||||TWO_SIDED|95.0|-19.56|-4.26||||||Week 48||-4.26|-19.56|
71719049|NCT02831855|142952902|SUPERIORITY||Difference in percentage of participants|-7.02|||||TWO_SIDED|95.0|-14.81|0.77||||||Week 36||0.77|-14.81|
71719050|NCT02831855|142952902|SUPERIORITY||Difference in percentage of participants|-10.02|||||TWO_SIDED|95.0|-17.68|-2.37||||||Week 48||-2.37|-17.68|
71719051|NCT02831855|142952903|SUPERIORITY||Difference in percentage of participants|-8.52|||||TWO_SIDED|95.0|-15.27|-1.78||||||Week 36||-1.78|-15.27|
71719052|NCT02831855|142952903|SUPERIORITY||Difference in percentage of participants|-1.33|||||TWO_SIDED|95.0|-8.5|5.83|||Two Sided|||Week 48||5.83|-8.50|
71719053|NCT02831855|142952904|SUPERIORITY||Difference in percentage of participants|-8.11|||||TWO_SIDED|95.0|-15.4|-0.82||||||Week 36||-0.82|-15.40|
71719054|NCT02831855|142952904|SUPERIORITY||Difference in percentage of participants|-6.21|||||TWO_SIDED|95.0|-13.74|1.32||||||Week 48||1.32|-13.74|
71719055|NCT02831855|142952905|SUPERIORITY||Difference in percentage of participants|-5.63|||||TWO_SIDED|95.0|-14.12|2.84||||||Week 36||2.84|-14.12|
71719056|NCT02831855|142952905|SUPERIORITY||Difference in percentage of participants|-4.13|||||TWO_SIDED|95.0|-12.62|4.36||||||Week 48||4.36|-12.62|
71719057|NCT02831855|142952906|SUPERIORITY||Difference in percentage of participants|-8.84|||||TWO_SIDED|95.0|-16.44|-1.24||||||Week 36||-1.24|-16.44|
71719058|NCT02831855|142952906|SUPERIORITY||Difference in percentage of participants|-2.41|||||TWO_SIDED|95.0|-10.18|5.35||||||Week 48||5.35|-10.18|
71719059|NCT02831855|142952907|SUPERIORITY||Difference in percentage of participants|-8.85|||||TWO_SIDED|95.0|-16.38|-1.31||||||Week 36||-1.31|-16.38|
71719060|NCT02831855|142952907|SUPERIORITY||Difference in percentage of participants|-3.16|||||TWO_SIDED|95.0|-10.99|4.65||||||Week 48||4.65|-10.99|
71719061|NCT02831855|142952908|SUPERIORITY||Difference in percentage of participants|-6.96|||||TWO_SIDED|95.0|-14.06|0.14||||||Week 36||0.14|-14.06|
71719062|NCT02831855|142952908|SUPERIORITY||Difference in percentage of participants|-6.59|||||TWO_SIDED|95.0|-13.8|0.61||||||Week 48||0.61|-13.80|
71719063|NCT02831855|142952909|SUPERIORITY||Difference in percentage of participants|-12.75|||||TWO_SIDED|95.0|-21.01|-4.48||||||Week 36||-4.48|-21.01|
71719064|NCT02831855|142952909|SUPERIORITY||Difference in percentage of participants|-11.99|||||TWO_SIDED|95.0|-20.22|-3.75||||||Week 48||-3.75|-20.22|
71719065|NCT02831855|142952910|SUPERIORITY||Difference in percentage of participants|-5.37|||||TWO_SIDED|95.0|-13.63|2.89||||||Week 36||2.89|-13.63|
71719066|NCT02831855|142952910|SUPERIORITY||Difference in percentage of participants|-4.97|||||TWO_SIDED|95.0|-13.32|3.36||||||Week 48||3.36|-13.32|
71719067|NCT02831855|142952911|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.02|0.16||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.16|0.02|
71719068|NCT02831855|142952911|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.06|0.09||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.||0.09|-0.06|
71719069|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.79|0.92||||||Change at Week 36: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||0.92|-1.79|
71719070|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-0.82|1.85||||||Change at Week 48: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.||1.85|-0.82|
71768669|NCT02047318|143037922|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-94.4|STANDARD_DEVIATION|98.915||0.0012|TWO_SIDED|95.0|-145.26|-43.55||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-43.55|-145.26|0.0012
71768670|NCT02047318|143037923|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-141.94|STANDARD_DEVIATION|117.992||0.032|TWO_SIDED|95.0|-265.77|-18.12||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-18.12|-265.77|0.032
71887425|NCT03569202|143295729|OTHER||Mean Difference (Final Values)|-17.0625||||0.0038|TWO_SIDED|95.0|-27.928|-6.197||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.1970|-27.9280|0.0038
71887426|NCT03569202|143295729|OTHER||Mean Difference (Final Values)|-15.0714||||0.0011|TWO_SIDED|95.0|-23.285|-6.8579||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline||-6.8579|-23.2850|0.0011
71719071|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.97|-0.37||||||Change at Week 36: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||-0.37|-2.97|
71719072|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.13|0.66||||||Change at Week 48: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.||0.66|-2.13|
71719073|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.21||||||Change at Week 36: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||1.21|-1.50|
71719074|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.95|0.93||||||Change at Week 48: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.||0.93|-1.95|
71719075|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.9|-0.01||||||Change at Week 36: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||-0.01|-2.90|
71719076|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.23|0.73||||||Change at Week 48: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.||0.73|-2.23|
71719077|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.29|0.49||||||Change at Week 36: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||0.49|-2.29|
71719078|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.94|1.02||||||Change at Week 48: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.||1.02|-1.94|
71719079|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.64|0.43||||||Change at Week 36: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||0.43|-2.64|
71719080|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-1.95|1.01||||||Change at Week 48: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.||1.01|-1.95|
71719081|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.52|0.22||||||Change at Week 36: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.22|-2.52|
71768671|NCT02047318|143037924|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-1.095|STANDARD_DEVIATION|0.7173|<|0.0001|TWO_SIDED|95.0|-1.464|-0.726||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||-0.726|-1.464|< 0.0001
71719082|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.94|0.91||||||Change at Week 48: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.||0.91|-1.94|
71719083|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.3|1.08||||||Change at Week 36: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.08|-1.30|
71719084|NCT02831855|142952912|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.6|1.83||||||Change at Week 48: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.||1.83|-0.60|
71719085|NCT02831855|142952913|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.01|0.37||||||Change at Week 36: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score- as a covariate.||0.37|-2.01|
71719086|NCT02831855|142952913|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.11|1.29||||||Change at Week 48: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (DMARD), and baseline SF-36 physical component score- as a covariate.||1.29|-1.11|
71719087|NCT02831855|142952913|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.13|0.49||||||Change at Week 36: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.49|-2.13|
71768672|NCT02047318|143037925|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores from baseline over time (to Week 158) was statistically significant.|Mean Difference (Net)|-0.958|STANDARD_DEVIATION|0.7868||0.0307|TWO_SIDED|95.0|-1.784|-0.132||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 158 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) scores was observed over time (with Week 158 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||-0.132|-1.784|0.0307
71887427|NCT01175005|143295783|SUPERIORITY_OR_OTHER|||||||0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71657064|NCT02944383|142831653|SUPERIORITY|||||||0.638||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6380
71719088|NCT02831855|142952913|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.06|0.7||||||Change at Week 48: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.||0.70|-2.06|
71719089|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-3.14|6.37||||||Change at Week 36: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||6.37|-3.14|
71719090|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-5.01|3.99||||||Change at Week 48: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.||3.99|-5.01|
71719091|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|3.19|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-0.51|6.89||||||Change at Week 36: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||6.89|-0.51|
71719092|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-2.41|5.61||||||Change at Week 48: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.||5.61|-2.41|
71719093|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-2.84|8.87||||||Change at Week 36: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||8.87|-2.84|
71719094|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-8.34|6.54||||||Change at Week 48: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.||6.54|-8.34|
71829452|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.8104|ONE_SIDED|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.42|0.8104
71887428|NCT02397473|143295784|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|1.63||0.036|TWO_SIDED|95.0|-6.72|-0.23|||Mixed Models Analysis|||||-0.23|-6.72|0.036
71719095|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|2.84|STANDARD_ERROR_OF_MEAN|3.45|||TWO_SIDED|95.0|-3.97|9.65||||||Change at Week 36: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||9.65|-3.97|
71719096|NCT02831855|142952914|SUPERIORITY||LS Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-10.72|5.8||||||Change at Week 48: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.||5.80|-10.72|
71719097|NCT02831855|142952915|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.07|-0.01||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||-0.01|-0.07|
71719098|NCT02831855|142952915|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.06|0.01||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.||0.01|-0.06|
71719099|NCT02831855|142952916|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.37|1.0||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.00|-1.37|
71719100|NCT02831855|142952916|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.07|1.44||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.||1.44|-1.07|
71719101|NCT02831855|142952917|SUPERIORITY||Difference in percentage of participants|-10.02|STANDARD_ERROR_OF_MEAN|3.87|||TWO_SIDED|95.0|-17.61|-2.42||||||Week 36||-2.42|-17.61|
71719102|NCT02831855|142952917|SUPERIORITY||Difference in percentage of participants|-6.62|STANDARD_ERROR_OF_MEAN|3.89|||TWO_SIDED|95.0|-14.26|1.0||||||Week 48||1.00|-14.26|
71719103|NCT01803880|142952929|NON_INFERIORITY|"Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference \<10.~Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0."|One-sided 97.5% confidence interval (CI)|-7.42|STANDARD_ERROR_OF_MEAN|5.137|>|0.05|ONE_SIDED|97.5|-19.29|||All unscheduled visits were to be included and nominal visits were to be applied using analysis visit windows. Both the assigned analysis visits and the site reported nominal visits were provided in the subject data listings.|ANCOVA|Due to early termination, all inferential analysis was interpreted as descriptive and carried out in an exploratory manner.||An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study-Control) was to be used for determining non-inferiority/superiority of the study device.|||-19.29|>0.05
71719104|NCT01152788|142952978|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.6|2.01|||Log Rank|||||2.01|0.6|0.76
71719105|NCT01152788|142952979|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-18.7|16.8||||||||16.8|-18.7|
71719106|NCT01152788|142952980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.55|TWO_SIDED|95.0|0.38|1.68|||Log Rank|||||1.68|0.38|0.55
71719107|NCT01152788|142952981|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Chi-squared|||||||0.01
71719108|NCT00889707|142952988|SUPERIORITY_OR_OTHER|||||||0.04||||||Test of superiority computed using an ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume. Tested for 2-sided 0.05 level of statistical significance.|ANCOVA|ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume.||||||0.040
71719109|NCT00889707|142952989|SUPERIORITY_OR_OTHER|||||||0.047||||||ANCOVA model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|ANCOVA|Model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.||||||0.047
71719110|NCT03542266|142952994|OTHER||Proportion (percent)|75.0|||||TWO_SIDED|95.0|46.5|90.3|||||Exact (Clopper-Pearson) 95% confidence interval for complete response rate.|||90.3|46.5|
71719111|NCT01445847|142953076|SUPERIORITY_OR_OTHER||Percentage|5.0|||<|0.05|TWO_SIDED|95.0|1.7|9.1|||Comparison of proportions|||We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) - percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 \> µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.||9.1|1.7|<0.05
71829453|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.7664|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7664
71719112|NCT00125788|142953077|SUPERIORITY|||||||0.076|||||||Cochran-Mantel-Haenszel|||||||0.076
71719113|NCT00125788|142953078|SUPERIORITY|||||||0.072|||||||Cochran-Mantel-Haenszel|||||||0.072
71719114|NCT00125788|142953079|SUPERIORITY|||||||0.129|||||||Cochran-Mantel-Haenszel|||||||0.129
71887429|NCT02397473|143295785|SUPERIORITY|||||||0.046|||||||ANCOVA|Koch's nonparametric randomization-based ANCOVA.||||||0.046
71887430|NCT02397473|143295786|SUPERIORITY||LSMean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.2||0.493|TWO_SIDED|95.0|-3.23|1.57|||Mixed Models Analysis|||||1.57|-3.23|0.493
71887431|NCT02397473|143295787|SUPERIORITY||Odds Ratio (OR)|3.046||||0.016|TWO_SIDED|95.0|1.242|7.469|||Mixed Models Analysis|||||7.469|1.242|0.016
71719115|NCT02628444|142953141|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (Group 2/Group 1) was greater than (\>) 1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.09|||||TWO_SIDED|95.0|0.862|1.39||||||Group 2/Group 1: Serotype 1||1.39|0.862|
71719116|NCT02628444|142953141|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.993|||||TWO_SIDED|95.0|0.82|1.2||||||Group 2/Group 1: Serotype 2||1.20|0.820|
71768673|NCT02047318|143037928|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|7.4|STANDARD_DEVIATION|210.32||0.8863|TWO_SIDED|95.0|-100.7|115.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||115.6|-100.7|0.8863
71768674|NCT02047318|143037929|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-184.3|STANDARD_DEVIATION|322.22||0.22|TWO_SIDED|95.0|-522.5|153.8||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||153.8|-522.5|0.22
71768675|NCT02047318|143037930|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|51.6|STANDARD_DEVIATION|89.77||0.0307|TWO_SIDED|95.0|5.4|97.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||97.7|5.4|0.0307
71768676|NCT02047318|143037931|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|42.3|STANDARD_DEVIATION|140.41||0.4934|TWO_SIDED|95.0|-105.0|189.7||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed over time (with Week 252 chosen as the end point, as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||189.7|-105|0.4934
71768677|NCT02047318|143037932|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels between MRX baseline and Week 48 was statistically significant|Mean Difference (Net)|21.2|STANDARD_DEVIATION|58.98||0.1571|TWO_SIDED|95.0|-9.1|51.6||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||51.6|-9.1|0.1571
71829454|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.7888|ONE_SIDED|95.0|-0.31||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.31|0.7888
71829455|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.393|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3930
71829456|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.4785|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.4785
71829457|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6756|ONE_SIDED|95.0|-0.34||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.34|0.6756
71887432|NCT02397473|143295788|SUPERIORITY||Odds Ratio (OR)|1.312||||0.575|TWO_SIDED|95.0|0.502|3.426|||Mixed Models Analysis|||||3.426|.502|0.575
71887433|NCT02397473|143295789|SUPERIORITY||Odds Ratio (OR)|0.965||||0.91|TWO_SIDED|95.0|0.512|1.819|||Mixed Models Analysis|Pseudo-likelihood-based repeated measures.||||1.819|.512|0.910
71719117|NCT02628444|142953141|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.983|||||TWO_SIDED|95.0|0.816|1.18||||||Group 2/Group 1: Serotype 3||1.18|0.816|
71829458|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.2627|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.2627
71887434|NCT02397473|143295790|SUPERIORITY||Odds Ratio (OR)|0.929||||0.841|TWO_SIDED|95.0|0.449|1.923|||Mixed Models Analysis|Pseudolikelihood-based repeated measures model||||1.923|0.449|0.841
71890227|NCT01795547|143302091|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.283||||0.004|TWO_SIDED|95.0|-0.477|-0.09||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||-0.090|-0.477|0.004
71719118|NCT02628444|142953141|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.809|1.14||||||Group 2/Group 1: Serotype 4||1.14|0.809|
71719119|NCT02628444|142953142|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.757|1.4||||||Group 2/Group 1: Serotype 1||1.40|0.757|
71768678|NCT02047318|143037933|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in AST levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|12.2|STANDARD_DEVIATION|101.84||0.7815|TWO_SIDED|95.0|-94.7|119.0||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in AST levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||119|-94.7|0.7815
71768679|NCT02047318|143037934|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-3.9|STANDARD_DEVIATION|257.78||0.9513|TWO_SIDED|95.0|-136.4|128.7||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||128.7|-136.4|0.9513
71768680|NCT02047318|143037935|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in GGT levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-56.7|STANDARD_DEVIATION|356.88||0.7133|TWO_SIDED|95.0|-431.2|317.9||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in GGT levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||317.9|-431.2|0.7133
71768681|NCT02047318|143037936|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|2.348||0.7839|TWO_SIDED|95.0|-1.05|1.37||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||1.37|-1.05|0.7839
71768682|NCT02047318|143037936|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between MRX baseline and Week 48 was statistically significant.|Mean Difference (Net)|-0.15|STANDARD_DEVIATION|0.982||0.5298|TWO_SIDED|95.0|-0.66|0.35||Data for this analysis were obtained from 19 participants at MRX baseline; 17 of those participants contributed Week 48 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed when comparing MRX baseline to Week 48. The analysis was based on the safety population.||0.35|-0.66|0.5298
71768683|NCT02047318|143037937|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.53|STANDARD_DEVIATION|5.505||0.8218|TWO_SIDED|95.0|-6.31|5.24||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in total bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||5.24|-6.31|0.8218
71829459|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2281|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2281
71829460|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.16||0.7656|ONE_SIDED|95.0|-0.38||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.38|0.7656
71829461|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.16||0.2105|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2105
71829462|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.2221|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2221
71829463|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.4396|ONE_SIDED|95.0|-0.23||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.23|0.4396
71719120|NCT02628444|142953142|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.897|||||TWO_SIDED|95.0|0.705|1.14||||||Group 2/Group 1: Serotype 2||1.14|0.705|
71719121|NCT02628444|142953142|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group 2/Group 1: Serotype 3||1.16|0.724|
71719122|NCT02628444|142953142|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.884|||||TWO_SIDED|95.0|0.72|1.09||||||Group 2/Group 1: Serotype 4||1.09|0.720|
71719123|NCT02628444|142953143|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.567|||||TWO_SIDED|98.75|0.399|0.805||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 1||0.805|0.399|
71719124|NCT02628444|142953143|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.746|||||TWO_SIDED|98.75|0.55|1.01||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 2||1.01|0.550|
71719125|NCT02628444|142953143|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.04|||||TWO_SIDED|98.75|0.686|1.57||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 3||1.57|0.686|
71719126|NCT02628444|142953143|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.647|||||TWO_SIDED|98.75|0.434|0.963||||||Group 1a Booster/Group 1 Post-dose 3: Serotype 4||0.963|0.434|
71719127|NCT02628444|142953144|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.627|||||TWO_SIDED|98.75|0.342|1.15||||||Group 2a Booster dose/Group 1 Post-dose 3: Serotype 1||1.15|0.342|
71719128|NCT02628444|142953144|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.809|||||TWO_SIDED|98.75|0.505|1.3||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 2||1.30|0.505|
71829464|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.15||0.2243|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2243
71829465|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.3597|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.3597
71887435|NCT01337973|143295796|SUPERIORITY||Coefficient estimate|0.82|||<|0.001|TWO_SIDED|95.0|0.37|1.84||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z value: -4.65|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.84|0.37|<0.001
71719129|NCT02628444|142953144|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|1.19|||||TWO_SIDED|98.75|0.732|1.94||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 3||1.94|0.732|
71719130|NCT02628444|142953144|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided Bonferroni corrected 95% CI for the ratio of GMTs between groups (Group 2a Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT Ratio|0.499|||||TWO_SIDED|98.75|0.331|0.754||||||Group 2a Booster/Group 1 Post-dose 3: Serotype 4||0.754|0.331|
71719131|NCT02628444|142953145|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.688|||||TWO_SIDED|98.75|0.479|0.989||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 1||0.989|0.479|
71719132|NCT02628444|142953145|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.871|||||TWO_SIDED|98.75|0.673|1.13||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 2||1.13|0.673|
71719133|NCT02628444|142953145|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|1.15|||||TWO_SIDED|98.75|0.887|1.49||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 3||1.49|0.887|
71829466|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.14||0.203|ONE_SIDED|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.12|0.2030
71829467|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.1207|ONE_SIDED|95.0|-0.07||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.07|0.1207
71719134|NCT02628444|142953145|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs within groups (Group 1b booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT paired ratio|0.655|||||TWO_SIDED|98.75|0.471|0.911||||||Group 1b Booster/Group 1 Post-dose 3: Serotype 4||0.911|0.471|
71719135|NCT02628444|142953146|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.889|||||TWO_SIDED|98.75|0.462|1.71||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 1||1.71|0.462|
71719136|NCT02628444|142953146|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.677|||||TWO_SIDED|98.75|0.402|1.14||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 2||1.14|0.402|
71719137|NCT02628444|142953146|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.911|||||TWO_SIDED|98.75|0.573|1.45||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 3||1.45|0.573|
71719138|NCT02628444|142953146|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 2b Booster/Group 1) was \>1/2. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.702|||||TWO_SIDED|98.75|0.447|1.1||||||Group 2b Booster/Group 1 Post-dose 3: Serotype 4||1.10|0.447|
71719139|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.05|||||TWO_SIDED|95.0|0.833|1.33||||||Group2/Group1: Serotype 1 (28 days after last vaccination)||1.33|0.833|
71719140|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.821|1.19||||||Group2/Group1: Serotype 2 (28 days after last vaccination)||1.19|0.821|
71719141|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.972|||||TWO_SIDED|95.0|0.81|1.17||||||Group2/Group1: Serotype 3 (28 days after last vaccination)||1.17|0.810|
71768684|NCT02047318|143037937|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels from baseline over time (to Week 252) was statistically significant.|Mean Difference (Net)|-0.52|STANDARD_DEVIATION|2.001||0.5549|TWO_SIDED|95.0|-2.62|1.58||Data for this analysis were obtained from 19 participants at MRX baseline; 6 of those participants contributed Week 252 data.|Student's t-test|||This analysis investigated whether a statistically significant change in direct bilirubin levels was observed over time (with Week 252 chosen as the end point as the last analysis visit with at least 6 participants). The analysis was based on the safety population.||1.58|-2.62|0.5549
71829468|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.1836|ONE_SIDED|95.0|-0.09||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.09|0.1836
71887436|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|0.62|||<|0.01|TWO_SIDED|95.0|0.3|1.29||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.83|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||1.29|0.30|<0.01
71719142|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.963|||||TWO_SIDED|95.0|0.814|1.14||||||Group2/Group1: Serotype 4 (28 days after last vaccination)||1.14|0.814|
71719143|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.762|1.39||||||Group2/Group1: Serotype 1 (1 year after last vaccination)||1.39|0.762|
71719144|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.917|||||TWO_SIDED|95.0|0.724|1.16||||||Group2/Group1: Serotype 2 (1 year after last vaccination)||1.16|0.724|
71719145|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.933|||||TWO_SIDED|95.0|0.742|1.17||||||Group2/Group1: Serotype 3 (1 year after last vaccination)||1.17|0.742|
71719146|NCT02628444|142953147|SUPERIORITY|The superiority was demonstrated if the lower limit of the two-sided 95% CI was greater than 1 between groups (Group 2/Group 1). Overall superiority of Group 2 to Group 1 was demonstrated if individual serotype null hypotheses were rejected.|GMT Ratio|0.916|||||TWO_SIDED|95.0|0.75|1.12||||||Group2/Group1: Serotype 4 (1 year after last vaccination)||1.12|0.750|
71719147|NCT02079909|142953184|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.3919|TWO_SIDED||||||Mixed Models Analysis|||||||0.3919
71719148|NCT02079909|142953185|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.7588|TWO_SIDED||||||Mixed Models Analysis|||||||0.7588
71719149|NCT02079909|142953186|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.3212|TWO_SIDED||||||Mixed Models Analysis|||||||0.3212
71719150|NCT02277249|142953187|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.||||0.36
71719151|NCT01869634|142953205|OTHER|Wilcoxon signed-rank test. Paired samples.||||||0.0025|||||||Sign test|||Comparison between HIV positive naïve to ART before and after ART has been done.||||0.0025
71719152|NCT01869634|142953206|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71719153|NCT01869634|142953206|OTHER|Wilcoxon signed-rank test||||||0.826|||||||Sign test|||Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.||||0.826
71719154|NCT01869634|142953207|OTHER|Two-sample Wilcoxon rank-sum (Mann-Whitney) test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||comparison between groups (HIV+ vs HIV-)||||<0.001
71719155|NCT01869634|142953207|OTHER|||||||0.807|||||||Sign test|||Changes in systemic immune activation through IL6||||0.807
71719156|NCT04551898|142953227|SUPERIORITY||Least square Mean|-0.25||||0.4829|TWO_SIDED|90.0|-0.84|0.34|||Mixed Models Analysis|||||0.34|-0.84|0.4829
71719157|NCT04551898|142953227|SUPERIORITY||Least square Mean|-0.51||||0.1739|TWO_SIDED|90.0|-1.13|0.11|||Mixed Models Analysis|||||0.11|-1.13|0.1739
71719158|NCT04551898|142953227|SUPERIORITY||Least square Mean|0.19||||0.6006|TWO_SIDED|90.0|-0.4|0.77|||Mixed Models Analysis|||||0.77|-0.40|0.6006
71719159|NCT04551898|142953227|SUPERIORITY|||||||0.4996||||||H0: there is a flat dose response curve comparing change from baseline to Day 8 in viral load in the Placebo and other BGB-DXP593 dose groups|t-test, 1 sided|MCP Mod was used to test the primary hypothesis and provide 1-sided p-value accordingly.||||||0.4996
71719160|NCT00559104|142953306|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.51||||0.51|TWO_SIDED|95.0|0.07|3.79|||Regression, Cox||"Parameter Dispersion Type: Standard Error of the Parameter Estimate, not of the mean.~Standard Error = 1.02475"|There is no power calculation as this is a phase II study. This is an Event-free Survival, in which an event can be Relapse/Progression, or Death. Censoring can be at the End of follow-up date, or at the End of study date.||3.79|0.07|0.51
71887437|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|1.16|||<|0.01|TWO_SIDED|95.0|0.36|3.77||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.31|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||3.77|0.36|<0.01
71719161|NCT00559104|142953307|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.66||||0.69|TWO_SIDED|95.0|0.09|4.99|||Regression, Cox||"Numerator: Carmustine in the conditioning. Denominator: Irradiation in the conditioning.~Parameter: Hazard ratio. Dispersion: Standard Error of the Hazard Ratio."|Phase II analysis: There was no power calculation.||4.99|0.09|0.69
71719162|NCT00620373|142953317|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||Significant difference p ≤ 0.05||||.016
71719163|NCT00620373|142953317|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||significant difference p ≤ 0.05||||.07
71719164|NCT00620373|142953318|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.016
71719165|NCT00620373|142953318|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||McNemar|||For all cancers; significant difference p ≤ 0.05||||.07
71719166|NCT00620373|142953318|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
71719167|NCT00620373|142953318|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||McNemar|||For invasive cancers; significant difference p ≤ 0.05||||.063
71719168|NCT00620373|142953318|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||.5
71719169|NCT00620373|142953318|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05||||>.99
71719170|NCT00620373|142953320|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
71719171|NCT00620373|142953320|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||McNemar|||significant difference p ≤ 0.05||||.069
71719172|NCT00620373|142953321|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||significant difference p ≤ 0.05||||<.001
71719173|NCT00620373|142953321|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||McNemar|||significant difference p ≤ 0.05||||.218
71719174|NCT01891396|142953421|SUPERIORITY|||||||0.0099|||||||ANOVA|||||||0.0099
71719175|NCT01891396|142953422|SUPERIORITY|||||||0.0367|||||||ANOVA|||||||0.0367
71719176|NCT01891396|142953423|SUPERIORITY|||||||0.0289|||||||ANOVA|||||||0.0289
71719177|NCT01891396|142953424|SUPERIORITY|||||||0.0141|||||||ANOVA|||||||0.0141
71719178|NCT01891396|142953425|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
71719179|NCT01891396|142953426|SUPERIORITY|||||||0.0533|||||||ANOVA|||||||0.0533
71719180|NCT01891396|142953427|SUPERIORITY|||||||0.0323|||||||ANOVA|||||||0.0323
71719181|NCT01891396|142953428|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
71719182|NCT01891396|142953429|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.0030
71719183|NCT01891396|142953430|SUPERIORITY|||||||0.044|||||||ANOVA|||||||0.0440
71719184|NCT01891396|142953431|SUPERIORITY|||||||0.0579|||||||ANOVA|||||||0.0579
71719185|NCT01891396|142953432|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71719186|NCT01891396|142953433|SUPERIORITY|||||||0.0046|||||||ANOVA|||||||0.0046
71719187|NCT01891396|142953434|SUPERIORITY|||||||0.0029|||||||ANOVA|||||||0.0029
71719188|NCT01891396|142953435|SUPERIORITY|||||||0.0087|||||||ANOVA|||||||0.0087
71719189|NCT01891396|142953436|SUPERIORITY|||||||0.0154|||||||ANOVA|||||||0.0154
71719190|NCT01891396|142953437|SUPERIORITY|||||||0.0227|||||||ANOVA|||||||0.0227
71719191|NCT01891396|142953438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
71719192|NCT01891396|142953439|SUPERIORITY|||||||0.0148|||||||ANOVA|||||||0.0148
71719193|NCT01891396|142953440|SUPERIORITY|||||||0.0113|||||||ANOVA|||||||0.0113
71719194|NCT01891396|142953441|SUPERIORITY|||||||0.0016|||||||ANOVA|||||||0.0016
71719195|NCT01891396|142953442|SUPERIORITY|||||||0.0056|||||||ANOVA|||||||0.0056
71719196|NCT01891396|142953443|SUPERIORITY|||||||0.0095|||||||ANOVA|||||||0.0095
71719197|NCT01891396|142953444|SUPERIORITY|||||||0.0136|||||||ANOVA|||||||0.0136
71719198|NCT01891396|142953445|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71719199|NCT01891396|142953446|SUPERIORITY|||||||0.0059|||||||ANOVA|||||||0.0059
71719200|NCT04229888|142953482|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in DEQ-5 score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.02|||||||ANOVA|||||||0.02
71719201|NCT04229888|142953483|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in MG score, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M= 1 representing the largest clinically acceptable difference based on historical data.||||||0.07|||||||ANOVA|||||||0.07
71719202|NCT04229888|142953484|NON_INFERIORITY|To establish non-inferiority of the treatment effect on the primary outcome change in TBUT, the upper bound of the two-sided 95% confidence interval on mean difference between the light based (sham) treatment and Lipiflow treatment were compared against a non-inferiority margin M=6 representing the largest clinically acceptable difference based on historical data.||||||0.66|||||||ANOVA|||||||0.66
71719203|NCT01282866|142953485|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71719204|NCT01299389|142953489|SUPERIORITY_OR_OTHER||Least squares (LS) means difference|-9.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-14.0|-5.4|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.||-5.4|-14.0|<0.0001
71829469|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17||0.2359|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.2359
71829470|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.2861|ONE_SIDED|95.0|-0.18||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.18|0.2861
71887438|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|0.51|||<|0.05|TWO_SIDED|95.0|0.19|1.38||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.26|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.38|0.19|<0.05
71719205|NCT01299389|142953492|SUPERIORITY_OR_OTHER||LS Mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.1|-1.4|||ANCOVA|||Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.4|-4.1|<0.0001
71719206|NCT01299389|142953492|SUPERIORITY_OR_OTHER||LS Mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.61||0.0012|TWO_SIDED|95.0|-3.2|-0.8|||ANCOVA|||Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.8|-3.2|0.0012
71719207|NCT01299389|142953492|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|-3.4|-1.1|||ANCOVA|||Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-1.1|-3.4|<0.0001
71719208|NCT01299389|142953492|SUPERIORITY_OR_OTHER||LS Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0023|TWO_SIDED|95.0|-2.3|-0.5|||ANCOVA|||Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.5|-2.3|0.0023
71719209|NCT01299389|142953492|SUPERIORITY_OR_OTHER||LS Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0025|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|||Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.||-0.4|-1.9|0.0025
71719210|NCT01299389|142953493|SUPERIORITY_OR_OTHER||LS Mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.59||0.0003|TWO_SIDED|95.0|-3.3|-1.0|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.0|-3.3|0.0003
71719211|NCT01299389|142953494|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-4.1|-1.5|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-1.5|-4.1|<0.0001
71829471|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.2151|ONE_SIDED|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.13|0.2151
71829472|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.3545|ONE_SIDED|95.0|-0.21||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.21|0.3545
71719212|NCT01299389|142953495|SUPERIORITY_OR_OTHER||LS Mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-6.9|-2.3|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.||-2.3|-6.9|<0.0001
71719213|NCT01151020|142953496|SUPERIORITY_OR_OTHER_LEGACY||Free from major adverse event rate (%)|96.4|||<|0.001|TWO_SIDED|95.0|91.0|99.0|||Exact binomial test|||Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.||99|91|< 0.001
71719214|NCT01151020|142953497|SUPERIORITY_OR_OTHER_LEGACY||Device success rate (%)|92.7|||<|0.001|TWO_SIDED|95.0|86.2|96.8|||Exact binomial test|||Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.||96.8|86.2|< 0.001
71657065|NCT02944383|142831653|SUPERIORITY|||||||0.7468||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7468
71719215|NCT01964378|142953513|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming equal mean values in both the cebranopadol and morphine groups, it was calculated that for the final analysis of the primary endpoint 170 subjects would have been required per treatment arm in the Per Protocol Set using a 2 sample-t-test for 90% power and a 1-sided significance level of α = 0.025.|point-estimate|-7.48|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-12.05|-2.918|||MMRM|||The MMRM (mixed model repeated measurement) model includes fixed effects of pooled country, treatment, week, treatment-by-week interaction, history of opioid intake, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable being the weekly average rescue medication intake.||-2.918|-12.05|< 0.0001
71719216|NCT01964378|142953514|NON_INFERIORITY|Non-inferiority margin of 8 mg. Assuming that 65% of the participants are available for the Per Protocol Set, a total of 524 participant would have to be allocated (randomized) to IMP. With 262 participants per group in the Full Analysis Set, the non-inferiority of cebranopadol as compared to morphine sulfate prolonged release could have been demonstrated with at least 98% power and a 1-sided significance level of α = 0.025.|point-estimate|-4.67|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-9.245|-0.099||MMRM model: fixed effects of pooled country, treatment, week, treatment-by-week interaction, opioid intake history, baseline pain intensity as covariate \& subject-specific random effects. Dependent variable: weekly average rescue medication intake.|MMRM (mixed model repeated measurement)|For participants with no data in the Maintenance Phase, the average amount of rescue medication over the last 3 days of titration was imputed.|Non-inferiority of cebranopadol compared with morphine will be established if the upper bound of the resulting 95% confidence interval for the average treatment difference is below the non-inferiority margin of 8mg.|The primary endpoint will be analyzed by means of a mixed-effects model for repeated measures (MMRM), based on observed case weekly averages. Under the assumption of a missing-at-random missing data mechanism, an MMRM does not require an imputation of missing data and can obtain an improved estimate of variance.||-0.099|-9.245|< 0.0001
71719217|NCT00149799|142953530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.73||||0.048|TWO_SIDED|95.0|1.01|8.59|||Regression, Cox|p-value is based on the likelihood ratio Chi-Square statistic.||Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.||8.59|1.01|0.048
71719218|NCT00149799|142953532|SUPERIORITY||Slope difference|-0.07006|STANDARD_ERROR_OF_MEAN|0.04163||0.093|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=556||"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group \[to be tested\]."||||0.0930
71719219|NCT00149799|142953533|SUPERIORITY||Slope difference|0.001176|STANDARD_ERROR_OF_MEAN|0.03991||0.9766|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=43||"We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.9766
71719220|NCT00149799|142953534|SUPERIORITY||Slope difference|0.05723|STANDARD_ERROR_OF_MEAN|0.1963||0.7724|TWO_SIDED|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=36||"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group \[to be tested\]."||||0.7724
71738995|NCT00620113|142990735|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.77||||0.017|TWO_SIDED|95.0|-50.37|-3.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-3.16|-50.37|0.017
71768685|NCT02296138|143037938|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Ratio of rates vs. Tiotropium 5 μg|0.93||||0.0498|TWO_SIDED|99.0|0.85|1.02|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of moderate to severe COPD exacerbation was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.02|0.85|0.0498
71768686|NCT02296138|143037938|SUPERIORITY||Ratio of rates|0.89||||0.001|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on SPARK/FLAME- Covariates: Smoking status, baseline inhaled corticosteroid, Global Initiative on Chronic Obstructive Lung Disease stage, region, COPD Assessment Test score (replacing baseline symptom score), exacerbations treated with antibiotics/steroids history in previous year (replacing 1-year history of exacerbations)||0.96|0.84|0.0010
71890228|NCT01795547|143302092|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.331||||0.149|TWO_SIDED|95.0|-0.12|0.782||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.782|-0.120|0.149
71719221|NCT01072136|142953536|NON_INFERIORITY_OR_EQUIVALENCE|Under the assumption of a clinical cure proportion of 75% for the Azithromycin/Cefixime group, a 10% non-inferiority margin (i.e., no more than a 10% lower cure rate in the placebo group) at the one-sided 0.05 significance level with 85% power required 270 study participants in each arm (540 total) using an unpooled Z-test (normal approximation). Anticipating that approximately 30% of enrolled participants would not be in the per protocol group, 772 participants were targeted for enrollment.|Risk Difference (RD)|14.0|||||ONE_SIDED|95.0|-12.2||||||Asymptotic one-sided 95% confidence limit for the difference in clinical cure proportions(placebo minus treatment) were computed so that the lower limit could be examined relative to the non-inferiority margin of -10%.|The primary efficacy outcome was MPC clinical cure at 2 months. This was a non-inferiority trial designed to reject the null hypothesis that placebo control is inferior to empiric therapy for MPC.|||-12.2|
71719222|NCT01392573|142953556|SUPERIORITY_OR_OTHER||Treatment contrast|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.84|||ANCOVA|ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate||||-0.84|-1.25|<0.0001
71719223|NCT03008070|142953558|SUPERIORITY||Risk Ratio (RR)|1.52|||=|0.061|TWO_SIDED|95.0|0.98|2.12|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 800 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.12|0.98|=0.061
71768687|NCT02296138|143037938|SUPERIORITY||Ratio of rates|0.91||||0.008|TWO_SIDED|95.0|0.85|0.98|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on HERMES- Covariates: age, sex, smoking status, baseline Long-acting Beta-agonist/inhaled corticosteroid, region and percent predicted post-bronchodilator Forced Expiratory Volume in One Second||0.98|0.85|0.0080
71768688|NCT02296138|143037938|SUPERIORITY||Ratio of rates|0.89||||0.0011|TWO_SIDED|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on TRINITY/TRILOGY- Covariates: Treatment, region, severity of airflow limitation, and smoking status as effects, and exacerbations treated with antibiotics/steroids in previous year.||0.96|0.84|0.0011
71768689|NCT02296138|143037939|SUPERIORITY|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Hazard Ratio (HR)|0.95||||0.1188|TWO_SIDED|99.0|0.87|1.03|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.03|0.87|0.1188
71768690|NCT02296138|143037940|SUPERIORITY||Ratio of events vs. Tiotropium 5 μg|0.89||||0.1265|TWO_SIDED|95.0|0.76|1.03|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of exacerbations leading to hospitalization was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.||1.03|0.76|0.1265
71768691|NCT02296138|143037941|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2773|TWO_SIDED|95.0|0.82|1.06|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.06|0.82|0.2773
71768692|NCT02296138|143037942|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7357|TWO_SIDED|95.0|0.67|1.75|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox's proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value||1.75|0.67|0.7357
71768693|NCT00711516|143037943|SUPERIORITY_OR_OTHER||Median Difference (Net)|-241.8||||0.7382|TWO_SIDED|95.0|-2470.0|2102.3||The hierarchical testing procedure was employed to control the studywise error rate at 0.05.|Wilcoxon (Mann-Whitney)|The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.||Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.||2102.3|-2470.0|0.7382
71768694|NCT00711516|143037944|SUPERIORITY_OR_OTHER||Median Difference (Net)|53.2||||0.1661|TWO_SIDED|95.0|-17.8|136.1|||Wilcoxon (Mann-Whitney)|||The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.||136.1|-17.8|0.1661
71768695|NCT00711516|143037945|SUPERIORITY_OR_OTHER||Median Difference (Net)|78.9||||0.5774|TWO_SIDED|95.0|-157.8|311.3|||Wilcoxon (Mann-Whitney)|||||311.3|-157.8|0.5774
71768696|NCT00711516|143037946|SUPERIORITY_OR_OTHER||Median Difference (Net)|90.1||||0.861|TWO_SIDED|95.0|-806.7|707.0|||Wilcoxon (Mann-Whitney)|||||707.0|-806.7|0.8610
71768697|NCT00711516|143037947|SUPERIORITY_OR_OTHER||Median Difference (Net)|252.8||||0.6907|TWO_SIDED|95.0|-1066.5|1523.8|||Wilcoxon (Mann-Whitney)|||||1523.8|-1066.5|0.6907
71768698|NCT00711516|143037948|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2456|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-8.0|0.2456
71768699|NCT00711516|143037949|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7115|TWO_SIDED|95.0|-8.0|9.0|||Wilcoxon (Mann-Whitney)|||||9.0|-8.0|0.7115
71768700|NCT00711516|143037950|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.0||||0.6103|TWO_SIDED|95.0|-13.0|19.0|||Wilcoxon (Mann-Whitney)|||||19.0|-13.0|0.6103
71768701|NCT00711516|143037951|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9619|TWO_SIDED|95.0|-18.0|17.0|||Wilcoxon (Mann-Whitney)|||||17.0|-18.0|0.9619
71768702|NCT00711516|143037952|SUPERIORITY_OR_OTHER||Median Difference (Net)|-335.5||||0.4544|TWO_SIDED|95.0|-1270.7|723.3|||Wilcoxon (Mann-Whitney)|||||723.3|-1270.7|0.4544
71719224|NCT03008070|142953558|SUPERIORITY||Risk Ratio (RR)|1.82|||=|0.004|TWO_SIDED|95.0|1.24|2.4|||Cochran-Mantel-Haenszel|||"The primary endpoint was a binary outcome (Yes/No). Responders rates were compared between the placebo and lanifibranor 1200 mg at the end of the treatment period (week 24) using a Cochran Mantel Haenzel test stratified on diabetic status at baseline (that was the stratified factors in the randomisation).~The CMH risk ratio is used to estimate the effect size. Patients with missing data are considered as non-responders."||2.4|1.24|=0.004
71719225|NCT00841412|142953586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|||<|0.05|TWO_SIDED|95.0|0.59|0.96|||Mixed Models Analysis||The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention.|||0.96|0.59|<0.05
71719226|NCT04409834|142953587|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.95||||0.028|TWO_SIDED|95.0|1.08|3.55|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.55|1.08|0.028
71719227|NCT04409834|142953588|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the FDAC arm divided by the total number of wins in the SDPAC arm. A win ratio greater than 1 was in favor of the FDAC arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.79||||0.087|TWO_SIDED|95.0|0.92|3.47|||Stratified Win-Ratio Analysis, 2-sided|||FDAC = Full Dose Anticoagulation; SDPAC = Standard Dose Prophylactic Anticoagulation||3.47|0.92|0.087
71719228|NCT04409834|142953589|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|1.04||||0.9|TWO_SIDED|95.0|0.54|2.01|||Stratified Win-Ratio Analysis, 2-sided|||||2.01|0.54|0.90
71719229|NCT04409834|142953590|SUPERIORITY|"Stratified Win-Ratio Analysis, 2-sided~* The estimated win ratio is calculated by taking the total number of wins in the Anti-platelet arm divided by the total number of wins in the No Anti-platelet arm. A win ratio greater than 1 was in favor of the Anti-platelet arm.~* The win ratio methodology is explained in the following reference Pocock et al. Eur Heart J 2012;33:176-82 (doi:10.1093/eurheartj/ehr352)."|Win Ratio|0.79||||0.53|TWO_SIDED|95.0|0.38|1.65|||Stratified Win-Ratio Analysis, 2-sided|||||1.65|0.38|0.53
71719230|NCT00928187|142953612|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|differences in proportions|5.6|||||TWO_SIDED|95.0|-5.1|16.4||||||||16.4|-5.1|
71719231|NCT00928187|142953612|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|difference in proportions|6.1|||||TWO_SIDED|95.0|-4.5|16.7||||||||16.7|-4.5|
71719232|NCT00928187|142953617|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71719233|NCT00928187|142953618|SUPERIORITY_OR_OTHER|||||||0.26|||||||Chi-squared|||||||0.26
71719234|NCT00928187|142953619|SUPERIORITY_OR_OTHER|||||||0.13|||||||Chi-squared|||||||0.13
71719235|NCT01682356|142953625|SUPERIORITY|||||||0.0153|||||||t-test, 2 sided|Paired||||||0.0153
71719236|NCT01682356|142953626|SUPERIORITY|||||||0.0131|||||||t-test, 2 sided|Paired||||||0.0131
71719237|NCT01682356|142953627|SUPERIORITY|||||||0.83||||||P value adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.83
71768703|NCT00711516|143037953|SUPERIORITY_OR_OTHER||Median Difference (Net)|6410.3||||0.0193|TWO_SIDED|95.0|1064.7|12087.3|||Wilcoxon (Mann-Whitney)|||||12087.3|1064.7|0.0193
71768704|NCT00711516|143037954|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1704|TWO_SIDED|95.0|-0.1|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.1|0.1704
71719238|NCT01682356|142953628|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 6.06 x 10\^-18.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71719239|NCT01682356|142953629|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 1.87 x 10\^-20.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71719240|NCT01682356|142953630|SUPERIORITY||||||<|1e-07||||||P values adjusted for multiplicity. Exact P value 8.23 x 10\^-21.|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71719241|NCT01682356|142953631|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
71768705|NCT00711516|143037955|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.0609|TWO_SIDED|95.0|-0.3|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.3|0.0609
71719242|NCT01682356|142953632|SUPERIORITY|||||||0.6847||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6847
71719243|NCT01682356|142953633|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
71719244|NCT01682356|142953634|SUPERIORITY|||||||0.4078||||||P values adjusted for multiplicity|ANOVA|Plasma nitrate values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.4078
71719245|NCT01682356|142953635|SUPERIORITY|||||||0.3042||||||P value adjusted for multiplicity|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3042
71719246|NCT01682356|142953636|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 3.469 x 10\^-7.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71719247|NCT01682356|142953637|SUPERIORITY||||||<|1e-07||||||P value adjusted for multiplicity. Exact P value 7.202 x 10\^-8|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||<0.0000001
71719248|NCT01682356|142953638|SUPERIORITY|||||||2.13e-06||||||P value adjusted for multiplicity. Exact P value 2.129 x 10\^-6.|ANOVA|Breath nitric oxide values were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.00000213
71719249|NCT01682356|142953639|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
71719250|NCT01682356|142953640|SUPERIORITY|||||||0.0598||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.05980
71719251|NCT01682356|142953641|SUPERIORITY|||||||0.3918||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.3918
71719252|NCT01682356|142953642|SUPERIORITY|||||||0.0987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.09870
71719253|NCT01682356|142953643|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
71719254|NCT01682356|142953644|SUPERIORITY|||||||0.6044||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.6044
71719255|NCT01682356|142953645|SUPERIORITY|||||||0.8819||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8819
71719256|NCT01682356|142953646|SUPERIORITY|||||||0.8987||||||P values adjusted for multiplicity|ANOVA|Values for blood pressure were analyzed using a repeated measures ANOVA followed by Holm-Šídák multiple comparison testing||||||0.8987
71719257|NCT02688192|142953711|SUPERIORITY|||||||0.39|||||||ANOVA|df = 33||Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||0.39
71719258|NCT02688192|142953711|SUPERIORITY|||||||0.49|||||||ANOVA|df = 33||Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.49
71719259|NCT02688192|142953711|SUPERIORITY|||||||0.83|||||||ANOVA|df = 33||Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.83
71719260|NCT02688192|142953712|SUPERIORITY|||||||0.98|||||||ANOVA|df = 33||Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.98
71719261|NCT02688192|142953712|SUPERIORITY|||||||0.85|||||||ANOVA|df = 29||Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.85
71719262|NCT02688192|142953713|SUPERIORITY|||||||0.29|||||||ANOVA|df = 29||||||.29
71768706|NCT00711516|143037956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0499|TWO_SIDED|95.0|-5.8|0.0||Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.|ANCOVA|||Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was \<= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were \<= 0.05. If any were \>0.05 subsequent p-values would be reported as nominal p-values.||-0.0|-5.8|0.0499
71768707|NCT00711516|143037957|SUPERIORITY_OR_OTHER|||||||0.7343||95.0|||||Fisher Exact|||||||0.7343
71768708|NCT00711516|143037958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2||||0.1246|TWO_SIDED|95.0|-1.8|14.3||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.|ANCOVA|||||14.3|-1.8|0.1246
71768709|NCT00711516|143037959|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.026||||0.7382|TWO_SIDED|95.0|-21.684|19.98|||Wilcoxon (Mann-Whitney)|||||19.980|-21.684|0.7382
71768710|NCT00711516|143037960|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.086||||1|TWO_SIDED|95.0|-19.195|25.043|||Wilcoxon (Mann-Whitney)|||||25.043|-19.195|1.000
71719263|NCT02688192|142953714|SUPERIORITY|||||||0.019|||||||ANOVA|df = 32||Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data||||.019
71768711|NCT00711516|143037961|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.282||||0.8861|TWO_SIDED|95.0|-11.46|14.77|||Wilcoxon (Mann-Whitney)|||||14.770|-11.460|0.8861
71768712|NCT00711516|143037962|SUPERIORITY_OR_OTHER||Median Difference (Net)|11.825||||0.4738|TWO_SIDED|95.0|-12.601|37.987|||Wilcoxon (Mann-Whitney)|||||37.987|-12.601|0.4738
71719264|NCT02688192|142953714|SUPERIORITY|||||||0.34|||||||ANOVA|df = 32||Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.||||.34
71719265|NCT02948582|142953729|SUPERIORITY||least squares mean|0.033||||0.1257|TWO_SIDED|95.0|-0.009|0.075|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.075|-0.009|0.1257
71719266|NCT02948582|142953729|SUPERIORITY||least squares mean|0.072||||0.0008|TWO_SIDED|95.0|0.03|0.113|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.113|0.030|0.0008
71719267|NCT02948582|142953729|SUPERIORITY||least squares mean|0.102|||<|0.0001|TWO_SIDED|95.0|0.061|0.144|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.144|0.061|<0.0001
71719268|NCT02948582|142953729|SUPERIORITY||least squares mean|0.108|||<|0.0001|TWO_SIDED|95.0|0.066|0.15|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.150|0.066|<0.0001
71719269|NCT02948582|142953729|SUPERIORITY||least squares mean|0.098|||<|0.0001|TWO_SIDED|95.0|0.056|0.14|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."||0.140|0.056|<0.0001
71719270|NCT02948582|142953730|SUPERIORITY||least squares mean|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.123|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.123|0.050|<0.0001
71719271|NCT02948582|142953730|SUPERIORITY||least squares mean|0.151|||<|0.0001|TWO_SIDED|95.0|0.114|0.187|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.187|0.114|<0.0001
71719272|NCT02948582|142953730|SUPERIORITY||least squares mean|0.156|||<|0.0001|TWO_SIDED|95.0|0.12|0.193|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.193|0.120|<0.0001
71719273|NCT02948582|142953730|SUPERIORITY||least squares mean|0.202|||<|0.0001|TWO_SIDED|95.0|0.165|0.239|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.239|0.165|<0.0001
71768713|NCT00711516|143037963|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test||||0.0573
71829473|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.7102|ONE_SIDED|95.0|-0.35||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.35|0.7102
71768714|NCT00711516|143037963|SUPERIORITY_OR_OTHER|||||||0.0754||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.0754
71768715|NCT00711516|143037964|SUPERIORITY_OR_OTHER|||||||0.2727||95.0|||||Pearson's Correlation Coefficient|||||||0.2727
71768716|NCT00711516|143037964|SUPERIORITY_OR_OTHER|||||||0.5671||95.0|||||Pearson's Correlation Coefficient|||||||.5671
71768717|NCT00711516|143037965|SUPERIORITY_OR_OTHER|||||||0.1169||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1169
71768718|NCT00711516|143037965|SUPERIORITY_OR_OTHER|||||||0.1634||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1634
71829474|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.3883|ONE_SIDED|95.0|-0.19||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.19|0.3883
71768719|NCT00711516|143037966|SUPERIORITY_OR_OTHER|||||||0.0692||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.0692
71768720|NCT00711516|143037966|SUPERIORITY_OR_OTHER|||||||0.8876||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.8876
71768721|NCT00711516|143037967|SUPERIORITY_OR_OTHER|||||||0.603||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.6030
71768722|NCT00711516|143037967|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||<.0001
71768723|NCT00711516|143037968|SUPERIORITY_OR_OTHER|||||||0.917||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.||||||0.9170
71768724|NCT00711516|143037968|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||.9642
71768725|NCT00711516|143037969|SUPERIORITY_OR_OTHER|||||||0.7813||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.7813
71768726|NCT00711516|143037969|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.1560
71768727|NCT00711516|143037970|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.9010
71768728|NCT00711516|143037970|SUPERIORITY_OR_OTHER|||||||0.0135||95.0|||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||||||0.0135
71768729|NCT00711516|143037979|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.841||||0.7053|TWO_SIDED|95.0|-27.778|19.313|||Wilcoxon (Mann-Whitney)|||||19.313|-27.778|0.7053
71768730|NCT00711516|143037980|SUPERIORITY_OR_OTHER||Median Difference (Net)|4.792||||0.5163|TWO_SIDED|95.0|-30.631|16.19|||Wilcoxon (Mann-Whitney)|||||16.190|-30.631|0.5163
71768731|NCT00711516|143037981|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.108||||0.8711|TWO_SIDED|95.0|-14.341|5.498|||Wilcoxon (Mann-Whitney)|||||5.498|-14.341|0.8711
71768732|NCT00711516|143037982|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.855||||0.1825||95.0|-15.357|25.714|||Wilcoxon (Mann-Whitney)|||||25.714|-15.357|0.1825
71768733|NCT00711516|143037983|SUPERIORITY_OR_OTHER||Median Difference (Net)|-323.5||||0.9282|TWO_SIDED|95.0|-9311.0|2375.5|||Wilcoxon (Mann-Whitney)|||||2375.5|-9311.0|0.9282
71768734|NCT00711516|143037984|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-1069.0|426.0|||Wilcoxon (Mann-Whitney)|||||426.0|-1069.0|1.0000
71768735|NCT00711516|143037985|SUPERIORITY_OR_OTHER||Median Difference (Net)|-82.8||||0.5284|TWO_SIDED|95.0|-788.0|165.5|||Wilcoxon (Mann-Whitney)|||||165.5|-788.0|0.5284
71768736|NCT00711516|143037986|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.8||||0.8997|TWO_SIDED|95.0|-3151.0|1006.5|||Wilcoxon (Mann-Whitney)|||||1006.5|-3151.0|0.8997
71768737|NCT00711516|143037987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.1||||0.1305|TWO_SIDED|95.0|-58.2|8.0|||ANCOVA|||||8.0|-58.2|0.1305
71890229|NCT01795547|143302093|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.753||||0.039|TWO_SIDED|95.0|0.093|3.412||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.412|0.093|0.039
71768738|NCT00420641|143038007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.485|TWO_SIDED|90.0|-2.6|1.05|||Mixed Model Repeated Measures (MMRM)||The point estimate was calculated as least square (LS) mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS total score at Week 10.||1.05|-2.60|0.485
71768739|NCT00420641|143038007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99||||0|TWO_SIDED|90.0|-5.75|-2.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-2.22|-5.75|0.000
71768740|NCT00420641|143038008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.252|TWO_SIDED|90.0|-1.28|0.23|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in Bech score at Week 10.||0.23|-1.28|0.252
71768741|NCT00420641|143038008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0|TWO_SIDED|90.0|-2.49|-1.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.||-1.05|-2.49|0.000
71768742|NCT00420641|143038009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66||||0.279|TWO_SIDED|90.0|-4.19|0.87|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR total score at Week 10.||0.87|-4.19|0.279
71768743|NCT00420641|143038009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.001|TWO_SIDED|90.0|-7.55|-2.68|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR total score at Week 10.||-2.68|-7.55|0.001
71768744|NCT00420641|143038010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.287|TWO_SIDED|90.0|-5.23|1.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR total score at Week 10.||1.12|-5.23|0.287
71768745|NCT00420641|143038010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23||||0.001|TWO_SIDED|90.0|-9.21|-3.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR total score at Week 10.||-3.25|-9.21|0.001
71768746|NCT00420641|143038011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.352|TWO_SIDED|90.0|-1.47|0.41|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.||0.41|-1.47|0.352
71768747|NCT00420641|143038011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|90.0|-2.62|-0.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.||-0.81|-2.62|0.002
71768748|NCT00420641|143038012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.168|TWO_SIDED|90.0|-2.27|0.2|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.||0.20|-2.27|0.168
71719274|NCT02948582|142953730|SUPERIORITY||least squares mean|0.199|||<|0.0001|TWO_SIDED|95.0|0.162|0.235|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0\_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.235|0.162|<0.0001
71719275|NCT02948582|142953731|SUPERIORITY||least squares mean|0.058||||0.0028|TWO_SIDED|95.0|0.021|0.095|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.095|0.021|0.0028
71719276|NCT02948582|142953731|SUPERIORITY||least squares mean|0.1|||<|0.0001|TWO_SIDED|95.0|0.063|0.137|||least squares mena|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.137|0.063|<0.0001
71719277|NCT02948582|142953731|SUPERIORITY||least squares mean|0.105|||<|0.0001|TWO_SIDED|95.0|0.068|0.142|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.142|0.068|<0.0001
71719278|NCT02948582|142953731|SUPERIORITY||least squares mean|0.135|||<|0.0001|TWO_SIDED|95.0|0.098|0.173|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.173|0.098|<0.0001
71719279|NCT02948582|142953731|SUPERIORITY||least squares mean|0.128|||<|0.0001|TWO_SIDED|95.0|0.091|0.166|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12\_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.||0.166|0.091|<0.0001
71719280|NCT03502915|142953779|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.053|STANDARD_DEVIATION|2.508||0.943|TWO_SIDED|95.0|-1.402|1.507|||t-test, 2 sided|||||1.507|-1.402|0.943
71719281|NCT03502915|142953780|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.443|STANDARD_DEVIATION|2.867||0.597|TWO_SIDED|95.0|-1.229|2.114|||t-test, 2 sided|||||2.114|-1.229|0.597
71719282|NCT03502915|142953781|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|1.28||0.748|TWO_SIDED|95.0|-0.629|0.869|||t-test, 2 sided|||||0.869|-0.629|0.748
71719283|NCT03502915|142953782|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|-2.634|STANDARD_DEVIATION|3.816||0.025|TWO_SIDED|95.0|-4.927|-0.341|||t-test, 2 sided|||||-0.341|-4.927|0.025
71719284|NCT03502915|142953783|EQUIVALENCE|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.056|STANDARD_DEVIATION|2.742||0.944|TWO_SIDED|95.0|-1.543|1.655|||t-test, 2 sided|||||1.655|-1.543|0.944
71768749|NCT00420641|143038012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.002|TWO_SIDED|90.0|-3.27|-0.97|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.||-0.97|-3.27|0.002
71768750|NCT00420641|143038013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.257|TWO_SIDED|90.0|-0.46|0.09|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS Item 2 score at Week 10.||0.09|-0.46|0.257
71768751|NCT00420641|143038013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.001|TWO_SIDED|90.0|-0.77|-0.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS Item 2 score at Week 10.||-0.25|-0.77|0.001
71768752|NCT00420641|143038014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.096|TWO_SIDED|90.0|-0.33|0.0|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.||-0.00|-0.33|0.096
71719285|NCT01107964|142953818|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71768753|NCT00420641|143038014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|90.0|-0.53|-0.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.||-0.22|-0.53|0.000
71890230|NCT01795547|143302094|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.764||||0.07|TWO_SIDED|95.0|-0.143|3.672||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||3.672|-0.143|0.070
71719286|NCT01107964|142953819|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71719287|NCT01107964|142953820|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71719288|NCT01107964|142953821|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71768754|NCT00420641|143038015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.576|TWO_SIDED|90.0|-1.84|0.91|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 total score at Week 10.||0.91|-1.84|0.576
71768755|NCT00420641|143038015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0|TWO_SIDED|90.0|-4.28|-1.64|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 total score at Week 10.||-1.64|-4.28|0.000
71719289|NCT00362882|142953825|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
71719290|NCT00906178|142953837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.57|1.94||||||||1.94|.57|
71719291|NCT00906178|142953838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.62|1.65||||||||1.65|.62|
71719292|NCT00906178|142953839|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.93|2.62||||||||2.62|.93|
71719293|NCT00906178|142953840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.37|1.3||||||||1.30|.37|
71719294|NCT03328832|142953853|EQUIVALENCE|equivalence means p value \> 0.05||||||0.276|||||||t-test, 2 sided|||||||0.276
71719295|NCT03328832|142953854|EQUIVALENCE|equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71719296|NCT03328832|142953855|EQUIVALENCE|Equivalence means p value \> 0.05||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71719297|NCT00778336|142953866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71719298|NCT00778336|142953866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71719299|NCT00778336|142953866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71719300|NCT00778336|142953866|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \> 0.||||||<0.0001
71719301|NCT00873821|142953871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.83|||<|0.001|TWO_SIDED|95.0|26.33|55.32|||Mixed Models Analysis|||Difference (placebo minus MK-0941) in change from baseline to Day 13||55.32|26.33|<0.001
71719302|NCT01166347|142953925|NON_INFERIORITY|The non-inferiority margin was 15%.|Difference in Percentages|3.7||||0.011|ONE_SIDED|95.0||12.56|||Wald test||Difference = Control - HeartWare|Primary endpoint is 2 year survival free from disabling stroke (Modified Rankin Scale \>=4), death, exchange, explant due to device malfunction or urgent transplantation. Subjects who are electively transplanted or explanted due to recovery (no disabling stroke) must survive to 2 years post original implant to be considered a success.||12.56||0.0110
71719303|NCT01166347|142953926|SUPERIORITY||Difference in Percentages|1.1||||0.5922|TWO_SIDED|95.0|-8.5|10.8||If p\<0.05, then the test is statistically significant.|Regression, Logistic|Treatment as the only independent variable.|Difference = HeartWare - Control|If non-inferiority is established for the primary endpoint, statistical testing for superiority and p-value estimation for the 3 secondary endpoints (incidence of bleeding, incidence of major infection, overall survival) will be performed in a pre-specified sequence and testing will continue at the nominal alpha level until the first non-significant result. This fixed sequence procedure strongly controls the family-wise error rate for the collection of the 3 secondary endpoints.||10.8|-8.5|0.5922
71719304|NCT02891226|142953945|SUPERIORITY||Odds Ratio (OR)|2.75||||0.079|TWO_SIDED|90.0|1.07|7.08|||Regression, Logistic|||||7.08|1.07|0.079
71719305|NCT02891226|142953945|SUPERIORITY||Odds Ratio (OR)|4.92||||0.003|TWO_SIDED|90.0|2.01|12.07|||Regression, Logistic|||||12.07|2.01|0.003
71719306|NCT02891226|142953945|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.001|TWO_SIDED|90.0|2.81|13.42|||Regression, Logistic|||||13.42|2.81|<0.001
71719307|NCT02891226|142953946|SUPERIORITY||Odds Ratio (OR)|4.31||||0.241|TWO_SIDED|90.0|0.55|33.58|||Regression, Logistic|||||33.58|0.55|0.241
71719308|NCT02891226|142953946|SUPERIORITY||Odds Ratio (OR)|11.16||||0.032|TWO_SIDED|90.0|1.76|70.64|||Regression, Logistic|||||70.64|1.76|0.032
71719309|NCT02891226|142953946|SUPERIORITY||Odds Ratio (OR)|16.04||||0.009|TWO_SIDED|90.0|2.82|91.32|||Regression, Logistic|||||91.32|2.82|0.009
71719310|NCT02891226|142953947|SUPERIORITY||Odds Ratio (OR)|2.0||||0.33|TWO_SIDED|90.0|0.62|6.45|||Regression, Logistic|||||6.45|0.62|0.330
71719311|NCT02891226|142953947|SUPERIORITY||Odds Ratio (OR)|5.72||||0.006|TWO_SIDED|90.0|2.02|16.21|||Regression, Logistic|||||16.21|2.02|0.006
71768756|NCT00420641|143038016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.209|TWO_SIDED|90.0|-0.38|0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.||0.05|-0.38|0.209
71768757|NCT00420641|143038016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002|TWO_SIDED|90.0|-0.6|-0.19|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.||-0.19|-0.60|0.002
71719312|NCT02891226|142953947|SUPERIORITY||Odds Ratio (OR)|3.52||||0.029|TWO_SIDED|90.0|1.37|9.07|||Regression, Logistic|||||9.07|1.37|0.029
71719313|NCT02891226|142953948|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.234||0.007|TWO_SIDED|90.0|-1.03|-0.25|||Mixed Models Analysis|||||-0.25|-1.03|0.007
71719314|NCT02891226|142953948|SUPERIORITY||LS Mean difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.21|-0.45|||Mixed Models Analysis|||||-0.45|-1.21|<0.001
71719315|NCT02891226|142953948|SUPERIORITY||LS Mean difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.188||0.005|TWO_SIDED|90.0|-0.84|-0.22|||Mixed Models Analysis|||||-0.22|-0.84|0.005
71719316|NCT02891226|142953950|SUPERIORITY||LS Mean difference (Final Values)|24.05|STANDARD_ERROR_OF_MEAN|6.358|<|0.001|TWO_SIDED|90.0|13.53|34.56|||Mixed Models Analysis|||||34.56|13.53|<0.001
71719317|NCT02891226|142953950|SUPERIORITY||LS Mean difference (Final Values)|29.46|STANDARD_ERROR_OF_MEAN|6.421|<|0.001|TWO_SIDED|90.0|18.84|40.08|||Mixed Models Analysis|||||40.08|18.84|<0.001
71719318|NCT02891226|142953950|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|5.185|<|0.001|TWO_SIDED|90.0|16.67|33.82|||Mixed Models Analysis|||||33.82|16.67|<0.001
71719319|NCT02891226|142953951|SUPERIORITY||LS Mean difference (Final Values)|7.91|STANDARD_ERROR_OF_MEAN|2.072|<|0.001|TWO_SIDED|90.0|4.48|11.34|||Mixed Models Analysis|||||11.34|4.48|<0.001
71719320|NCT02891226|142953951|SUPERIORITY||LS Mean difference (Final Values)|6.2|STANDARD_ERROR_OF_MEAN|2.102||0.004|TWO_SIDED|90.0|2.72|9.67|||Mixed Models Analysis|||||9.67|2.72|0.004
71719321|NCT02891226|142953951|SUPERIORITY||LS Mean difference (Final Values)|6.73|STANDARD_ERROR_OF_MEAN|1.686|<|0.001|TWO_SIDED|90.0|3.94|9.51|||Mixed Models Analysis|||||9.51|3.94|<0.001
71719322|NCT02891226|142953952|SUPERIORITY||LS Mean difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|1.927||0.008|TWO_SIDED|90.0|1.95|8.32|||Mixed Models Analysis|||Mental Component Summary (MCS)||8.32|1.95|0.008
71719323|NCT02891226|142953952|SUPERIORITY||LS Mean difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|1.951||0.033|TWO_SIDED|90.0|0.96|7.41|||Mixed Models Analysis|||Mental Component Summary (MCS)||7.41|0.96|0.033
71719324|NCT02891226|142953952|SUPERIORITY||LS Mean difference (Final Values)|3.71|STANDARD_ERROR_OF_MEAN|1.589||0.021|TWO_SIDED|90.0|1.08|6.34|||Mixed Models Analysis|||Mental Component Summary (MCS)||6.34|1.08|0.021
71719325|NCT02891226|142953952|SUPERIORITY||LS Mean difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|1.319||0.229|TWO_SIDED|90.0|-0.59|3.77|||Mixed Models Analysis|||Physical Component Summary (PCS)||3.77|-0.59|0.229
71719326|NCT02891226|142953952|SUPERIORITY||LS Mean difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|1.349|<|0.001|TWO_SIDED|90.0|2.67|7.14|||Mixed Models Analysis|||Physical Component Summary (PCS)||7.14|2.67|<0.001
71719327|NCT02891226|142953952|SUPERIORITY||LS Mean difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|1.078||0.001|TWO_SIDED|90.0|1.81|5.38|||Mixed Models Analysis|||Physical Component Summary (PCS)||5.38|1.81|0.001
71719328|NCT00145626|142953962|SUPERIORITY_OR_OTHER||Cumulative Incidence|0.214|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED||||||||The cumulative incidence estimate and its standard error for occurrence of regimen-related mortality by the end of the first 100 days post-transplant was calculated.|||||
71719329|NCT01102491|142954035|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71719330|NCT03533660|142954054|SUPERIORITY||||||<|0.05||||||Applies to SOCRATES subscales recognition, ambivalence, taking steps at 6 weeks|t-test, 2 sided|||||||<.05
71719331|NCT03533660|142954054|SUPERIORITY||||||>|0.05||||||Applies to SOCRATES total scores and subscales (recognition, ambivalence, and taking steps) at intake and 3 months|t-test, 2 sided|||||||>.05
71768758|NCT00420641|143038017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.175|TWO_SIDED|90.0|-1.23|0.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.||0.12|-1.23|0.175
71768759|NCT00420641|143038017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003|TWO_SIDED|90.0|-1.79|-0.5|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.||-0.50|-1.79|0.003
71768760|NCT00420641|143038017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.082|TWO_SIDED|90.0|-1.92|-0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.||-0.05|-1.92|0.082
71829475|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.2228|ONE_SIDED|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.14|0.2228
71829476|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.6342|ONE_SIDED|95.0|-0.32||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.32|0.6342
71829477|NCT00430300|143163122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.14||0.3141|ONE_SIDED|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.16|0.3141
71829478|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.27||0.27|ONE_SIDED|95.0|-0.28||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.28|0.2700
71829479|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.26||0.1831|ONE_SIDED|95.0|-0.2||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.20|0.1831
71890231|NCT01795547|143302095|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.922||||0.13|TWO_SIDED|95.0|-0.275|2.119||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||2.119|-0.275|0.130
71719332|NCT03533660|142954055|SUPERIORITY||||||>|0.05||||||Applies to alcohol self-efficacy scale total score and subscales scores at intake, 6 weeks and 3 months|t-test, 2 sided|||||||>.05
71719333|NCT00996658|142954058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.0001||95.0|-0.83|-0.31|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.31|-0.83|< 0.0001
71719334|NCT00996658|142954059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001||95.0|-0.61|-0.21|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.21|-0.61|< 0.0001
71719335|NCT00996658|142954060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.79|-0.28|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.28|-0.79|< 0.0001
71719336|NCT00996658|142954061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.8|-0.29|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre||||-0.29|-0.80|< 0.0001
71768761|NCT00420641|143038017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.001|TWO_SIDED|90.0|-2.64|-0.9|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.||-0.90|-2.64|0.001
71829480|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.23||0.1796|ONE_SIDED|95.0|-0.17||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.17|0.1796
71719337|NCT00996658|142954062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.939||||0.0033|TWO_SIDED|95.0|1.432|6.032|||Regression, Logistic|||Linagliptin vs Placebo||6.032|1.432|0.0033
71719338|NCT00996658|142954063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.902||||0.0074|TWO_SIDED|95.0|1.44|10.572|||Regression, Logistic|||Linagliptin vs Placebo||10.572|1.440|0.0074
71719339|NCT00996658|142954064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.059||||0.0071|TWO_SIDED|95.0|1.216|3.485|||Regression, Logistic|||Linagliptin vs. Placebo||3.485|1.216|0.0071
71719340|NCT00996658|142954065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.028||95.0|-19.6|-1.1|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.1|-19.6|0.0280
71719341|NCT00996658|142954066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7||||0.0006||95.0|-24.5|-6.8|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-6.8|-24.5|0.0006
71719342|NCT00996658|142954067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.021||95.0|-20.2|-1.7|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||-1.7|-20.2|0.0210
71719343|NCT00996658|142954068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2137||95.0|-16.0|3.6|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre||||3.6|-16.0|0.2137
71719344|NCT04446312|142954080|NON_INFERIORITY|The pre-defined non-inferiority margin was 10%.|Risk Difference (RD)|0.15|||<|0.001|TWO_SIDED|95.0|-3.97|4.27|||Mantel Haenszel|||||4.27|-3.97|<0.001
71768762|NCT00420641|143038018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.208|TWO_SIDED|90.0|-0.45|0.06|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CGI-S score at Week 10.||0.06|-0.45|0.208
71719345|NCT00200967|142954109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.0||0.99||95.0|-14.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for AM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design. A sample size of 40 participants per genotype was required to detect a difference of 25 L/min in AM PEF (and relevant effect sizes for secondary outcomes) with a two-sided, 0.05 significance level test with 90% statistical power and a 15% drop-out rate.||14|-14|0.99
71719346|NCT00200967|142954110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.82||95.0|-15.0|12.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||12|-15|0.82
71719347|NCT00200967|142954111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.31||95.0|-1.6|0.5|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PEF variability.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.5|-1.6|0.31
71719348|NCT00200967|142954112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.09||95.0|-0.02|0.07|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for asthma symptoms.|A mixed-effects linear model was attempted but could not converge because very few symptoms were recorded, so a nonparametric analysis was applied.||0.07|-0.02|0.09
71719349|NCT00200967|142954113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.25||95.0|-0.1|0.2|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for rescue medication use.|A mixed-effects linear model was attempted but could not converge because very few usages of rescue medications were recorded, so a nonparametric analysis was applied.||0.2|-0.1|0.25
71719350|NCT00200967|142954114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.34||95.0|-0.1|0.03|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.03|-0.10|0.34
71719351|NCT00200967|142954115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.91||95.0|-0.08|0.07|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.07|-0.08|0.91
71719352|NCT00200967|142954116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|7.0||0.93||95.0|-15.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||14|-15|0.93
71719353|NCT00200967|142954117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.13||95.0|-0.04|0.31|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for eNO.|A mixed-effects linear model was applied to the natural logarithm of eNO to account for the repeated measurements within each treatment period of the crossover design.||0.31|-0.04|0.13
71719354|NCT00200967|142954118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.79||95.0|-0.56|0.43|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for EBC.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.43|-0.56|0.79
71719355|NCT00200967|142954119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.45||0.004||95.0|0.43|2.21|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for methacholine PC20.|A mixed-effects linear model was applied to the base-2 logarithm of the methacholine PC20 to account for the repeated measurements within each treatment period of the crossover design.||2.21|0.43|0.004
71768763|NCT00420641|143038018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0|TWO_SIDED|90.0|-0.76|-0.28|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CGI-S score at Week 10.||-0.28|-0.76|0.000
71768764|NCT00420641|143038019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76||||0.516|TWO_SIDED|90.0|-2.71|6.24|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MEI total score at Week 10.||6.24|-2.71|0.516
71768765|NCT00420641|143038019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22||||0.016|TWO_SIDED|90.0|1.97|10.48|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MEI total score at Week 10.||10.48|1.97|0.016
71887439|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|1.22|||<|0.001|TWO_SIDED|95.0|0.66|2.28||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.79|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.28|0.66|<0.001
71719356|NCT00200967|142954120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89||95.0|-0.23|0.26|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for ACQ.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.||0.26|-0.23|0.89
71719357|NCT01444430|142954129|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).|Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.698|1.65|||Regression, Cox|||||1.650|0.698|
71719358|NCT01444430|142954130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.835||||0.002|TWO_SIDED|95.0|0.745|0.937|||Regression, Cox|||||0.937|0.745|0.002
71719359|NCT01444430|142954131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|3.3|5.4|||ANOVA|||||5.4|3.3|<0.001
71719360|NCT01444430|142954132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.272|TWO_SIDED|95.0|-0.5|1.7|||ANOVA|||||1.7|-0.5|0.272
71719361|NCT01444430|142954133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||ANOVA|||||-0.1|-0.2|<0.001
71719362|NCT01444430|142954134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06|||ANCOVA|||||-0.06|-0.10|<0.001
71719363|NCT01444430|142954135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-1.0|-0.2|||ANOVA|||||-0.2|-1.0|0.004
71719364|NCT01444430|142954136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.095|TWO_SIDED|95.0|0.518|1.055|||Regression, Cox|||||1.055|0.518|0.095
71719365|NCT00276406|142954144|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||<0.01
71719366|NCT00276406|142954148|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.||||0.096
71719367|NCT00276406|142954149|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||||||0.02
71719368|NCT00276406|142954150|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||0.005
71719369|NCT00276406|142954151|SUPERIORITY_OR_OTHER||||||<|0.04||95.0|||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.||||<0.04
71719370|NCT02297815|142954156|SUPERIORITY_OR_OTHER||Score difference|-1.4||||0.008|TWO_SIDED|95.0|-2.44|-0.36|||Weighted linear regression|Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.|Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.||-0.36|-2.44|0.008
71719371|NCT02297815|142954157|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||7.9|-3.1|0.39
71719372|NCT02297815|142954158|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.59|TWO_SIDED|95.0|-3.9|6.8|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||6.8|-3.9|0.59
71719373|NCT02297815|142954159|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||17.2|7.3|<0.001
71719374|NCT02297815|142954160|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.9||||0.09|TWO_SIDED|95.0|-0.8|10.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||10.6|-0.8|0.09
71829481|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.8136|ONE_SIDED|95.0|-0.79||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.79|0.8136
71719375|NCT02297815|142954161|SUPERIORITY||Risk Difference (RD)|4.6||||0.07|TWO_SIDED|95.0|-0.3|9.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.||9.6|-0.3|0.07
71719376|NCT01061723|142954182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.966|TWO_SIDED|95.0|0.4|2.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||Sarilumab group was compared to placebo group. Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived.||2.5|0.4|0.966
71719377|NCT01061723|142954182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.467|TWO_SIDED|95.0|0.6|3.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.5|0.6|0.467
71719378|NCT01061723|142954182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.559|TWO_SIDED|95.0|0.3|1.9||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||1.9|0.3|0.559
71719379|NCT01061723|142954182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.496|TWO_SIDED|95.0|0.6|3.4||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||3.4|0.6|0.496
71719380|NCT01061723|142954182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.143|TWO_SIDED|95.0|0.8|4.2||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||||4.2|0.8|0.143
71768766|NCT00420641|143038020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.126|TWO_SIDED|90.0|-0.13|3.57|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.||3.57|-0.13|0.126
71768767|NCT00420641|143038020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.957|TWO_SIDED|90.0|-1.69|1.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.||1.81|-1.69|0.957
71829482|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6877|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.6877
71719381|NCT02476032|142954202|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
71829483|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.6382|ONE_SIDED|95.0|-0.54||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.54|0.6382
71719382|NCT02476032|142954203|OTHER|||||||0.05|TWO_SIDED|90.0||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.||||0.05
71719383|NCT01537315|142954209|SUPERIORITY_OR_OTHER|||||||0.4521|TWO_SIDED|||||A paired comparison between baseline CRP values with values obtained after 1, 3, and 6 months of treatment was conducted, with a p-value of 0.05 used as the a priori threshold of statistical significance.|ANOVA|||||||0.4521
71719384|NCT02197572|142954211|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.2||||||Change from Baseline at 0.25 Hours Postdose||2.2||
71719385|NCT02197572|142954211|OTHER||Least Squares Mean|-8.3|||||ONE_SIDED|95.0||-4.0||||||Change from Baseline at 0.5 Hours Postdose||-4.0||
71719386|NCT02197572|142954211|OTHER||Least Squares Mean|-1.8|||||ONE_SIDED|95.0||2.6||||||Change from Baseline at 1 Hour Postdose||2.6||
71719387|NCT02197572|142954211|OTHER||Least Squares Mean|-2.7|||||ONE_SIDED|95.0||1.7||||||Change from Baseline at 1.5 Hours Postdose||1.7||
71719388|NCT02197572|142954211|OTHER||Least Squares Mean|-5.0|||||ONE_SIDED|95.0||-0.6||||||Change from Baseline at 2 Hours Postdose||-0.6||
71768768|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.5061|TWO_SIDED|90.0|0.21|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 1.||1.93|0.21|0.5061
71719389|NCT02197572|142954211|OTHER||Least Squares Mean|-7.6|||||ONE_SIDED|95.0||-3.2||||||Change from Baseline at 2.5 Hours Postdose||-3.2||
71719390|NCT02197572|142954211|OTHER||Least Squares Mean|-9.1|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 3 Hours Postdose||-4.6||
71719391|NCT02197572|142954211|OTHER||Least Squares Mean|-7.2|||||ONE_SIDED|95.0||-2.9||||||Change from Baseline at 4 Hours Postdose||-2.9||
71719392|NCT02197572|142954211|OTHER||Least Squares Mean|-8.8|||||ONE_SIDED|95.0||-4.6||||||Change from Baseline at 6 Hours Postdose||-4.6||
71719393|NCT02197572|142954211|OTHER||Least Squares Mean|-2.2|||||ONE_SIDED|95.0||2.4||||||Change from Baseline at 8 Hours Postdose||2.4||
71719394|NCT02197572|142954211|OTHER||Least Squares Mean|-6.6|||||ONE_SIDED|95.0||-0.5||||||Change from Baseline at 10 Hours Postdose||-0.5||
71719395|NCT02197572|142954211|OTHER||Least Squares Mean|7.1|||||ONE_SIDED|95.0||11.4||||||Change from Baseline at 24 Hours Postdose||11.4||
71719396|NCT02197572|142954211|OTHER||Least Squares Mean|2.8|||||ONE_SIDED|95.0||8.1||||||Change from Baseline at 48 Hours Postdose||8.1||
71768769|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.7398|TWO_SIDED|90.0|0.46|3.25|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 1.||3.25|0.46|0.7398
71768770|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9209|TWO_SIDED|90.0|0.52|2.08|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 2.||2.08|0.52|0.9209
71829484|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.36||0.766|ONE_SIDED|95.0|-0.87||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.87|0.7660
71887440|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|0.8|||<|0.05|TWO_SIDED|95.0|0.32|1.98||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.01|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||1.98|0.32|<0.05
71719397|NCT02975804|142954229|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71719398|NCT02975804|142954230|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71719399|NCT02975804|142954231|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71719400|NCT02975804|142954232|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71719401|NCT02975804|142954233|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71719402|NCT02975804|142954234|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71719403|NCT02975804|142954238|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71768771|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.2908|TWO_SIDED|90.0|0.78|3.13|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 2.||3.13|0.78|0.2908
71768772|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0086|TWO_SIDED|90.0|0.23|0.72|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 3.||0.72|0.23|0.0086
71829485|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.7226|ONE_SIDED|95.0|-0.8||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.80|0.7226
71829486|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.31||0.6634|ONE_SIDED|95.0|-0.65||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.65|0.6634
71719404|NCT02975804|142954239|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71719405|NCT04263766|142954299|EQUIVALENCE|We tested whether TMS delivered to DLPFC had a difference effect on confidence compared to delivered to Vertex.|||||<|0.001|||||||t-test, 2 sided|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in confidence across all 4 delay conditions compared to TMS to the vertex.||||<.001
71719406|NCT04263766|142954299|EQUIVALENCE|We tested whether TMS to DLPFC leads to equivalent increase in confidence for four delay conditions.||||||0.99|||||||ANOVA|||||||0.99
71719407|NCT04263766|142954299|EQUIVALENCE|We tested whether TMS delivered to Vertex leads to a same effect on confidence regardless of the delay conditions.||||||0.83|||||||ANOVA|||||||0.83
71719408|NCT04263766|142954300|EQUIVALENCE|We used a two-way ANOVA to test whether TMS affected Mratio differently for DLPFC and Vertex and across different delay conditions.|||||>|0.19|||||||ANOVA|||Our null hypothesis is TMS to DLPFC would not lead to a significant change in Mratio across all 4 delay conditions compared to TMS to the vertex.||||>0.19
71719409|NCT02553928|142954309|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.19||0.097|TWO_SIDED|95.0|-0.06|0.69||Based on full analysis set|ANCOVA||The comparison is to BID memantine.|The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.||0.69|-0.06|0.097
71768773|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8087|TWO_SIDED|90.0|0.64|1.83|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 3.||1.83|0.64|0.8087
71768774|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||0.0002|TWO_SIDED|90.0|0.18|0.52|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 4.||0.52|0.18|0.0002
71768775|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.4606|TWO_SIDED|90.0|0.78|1.94|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 4.||1.94|0.78|0.4606
71719410|NCT02440139|142954321|SUPERIORITY||difference in sensitivity|-0.124|STANDARD_DEVIATION|0.034|<|0.05|TWO_SIDED|95.0|-0.186|-0.062|||Mixed Models Analysis|||||-0.062|-0.186|<0.05
71719411|NCT02440139|142954322|SUPERIORITY||Difference in LROC curves|-0.14|STANDARD_DEVIATION|0.039|<|0.05|TWO_SIDED|95.0|-0.209|-0.071|||ANOVA|||For each study arm, the difference in the least-squares means of the two arms was estimated. A two-sided 95% confidence interval on this difference in study arms (i.e. unaided minus aided by the software) was used to test the hypothesis that the difference in the area under the LROC curve (AUC). The superiority of ClearRead CT will be concluded if the upper bound of the two-sided 95% confidence interval on the difference is less than zero.||-0.071|-0.209|<0.05
71719412|NCT02933879|142954324|SUPERIORITY|||||||0.4615|||||||Z-test, 2 sided|||||||0.4615
71719413|NCT02933879|142954326|SUPERIORITY|||||||0.0404|||||||Z-test, 2 sided|||||||0.0404
71719414|NCT02933879|142954326|SUPERIORITY|||||||0.2106|||||||Z-test, 2 sided|||||||0.2106
71719415|NCT02933879|142954328|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
71719416|NCT02933879|142954330|SUPERIORITY|||||||1|||||||Z-test, 2 sided|||||||1.0000
71719417|NCT02933879|142954333|SUPERIORITY|||||||0.2467|||||||Z-test, 2 sided|||||||0.2467
71719418|NCT00075764|142954336|OTHER||Hazard Ratio (HR)|0.8||||0.007|TWO_SIDED|95.0|0.68|0.94|||Log Rank|Two-sided stratified log-rank test||||0.94|0.68|0.007
71719419|NCT00075764|142954338|OTHER||Hazard Ratio (HR)|0.81||||0.049|TWO_SIDED|95.0|0.65|1.0|||Log Rank|A log-rank test, stratified according to prior or no prior tamoxifen therapy.||||1.00|0.65|0.049
71719420|NCT01773967|142954358|SUPERIORITY|||||||0.83|||||||Mantel Haenszel|||||||0.83
71719421|NCT01773967|142954360|SUPERIORITY|||||||0.26|||||||Van Elteren's modification Mann-Whitney|||||||0.26
71719422|NCT01135459|142954361|OTHER||Odds Ratio (OR)|0.7649||||0.3989|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Analysis was performed using a logistic regression model with treatment and stratification factors as main factors.||1.4|0.4|0.3989
71719423|NCT02413996|142954388|SUPERIORITY||Mean Difference (Net)|5.94|STANDARD_DEVIATION|5.3||0.05|TWO_SIDED|95.0|-4.62|16.51|||t-test, 2 sided|||Does VRRS rehabilitation is superior to the traditional one?||16.51|-4.62|0.05
71719424|NCT01672879|142954401|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.5||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.5|-1.2|
71719425|NCT01672879|142954401|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|0.1|||||TWO_SIDED|95.0|-1.2|1.4||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.||1.4|-1.2|
71719426|NCT01672879|142954402|SUPERIORITY|||||||0.41|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.41
71719427|NCT01672879|142954402|SUPERIORITY|||||||0.065|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (\< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.||||0.065
71719428|NCT03810014|142954442|SUPERIORITY||Risk Difference (RD)|2.5||||0.01|TWO_SIDED|98.0|0.2|4.8|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||4.80|0.20|0.01
71719429|NCT03810014|142954442|SUPERIORITY||Risk Ratio, log|1.025||||0.012|TWO_SIDED|98.0|1.002|1.049|||Generalized estimating equations|||(Arm 3 + Arm 4) vs (Arm 1 + Arm 2)||1.049|1.002|0.012
71887441|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|0.6|||<|0.001|TWO_SIDED|95.0|0.25|1.46||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||1.46|0.25|<0.001
71719430|NCT03810014|142954442|SUPERIORITY||Risk Difference (RD)|-0.6||||0.33|TWO_SIDED|98.0|-2.2|0.9|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||0.90|-2.20|0.33
71719431|NCT03810014|142954442|SUPERIORITY||Risk Ratio, log|0.994||||0.332|TWO_SIDED|98.0|0.979|1.009|||Generalized estimating equations|||(Arm 1 + Arm 3) vs (Arm 2 + Arm 4)||1.009|0.979|0.332
71719432|NCT02148263|142954478|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71719433|NCT02148263|142954479|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71719434|NCT02148263|142954480|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||.94
71719435|NCT02148263|142954481|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||.96
71719436|NCT02148263|142954482|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
71719437|NCT02148263|142954483|SUPERIORITY|This is for the upper eyelid evaluation.||||||0.27|||||||Fisher Exact|||||||.27
71768776|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.1399|TWO_SIDED|90.0|0.4|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 5.||1.05|0.40|0.1399
71719438|NCT02148263|142954483|SUPERIORITY|||||||0.58|||||||Fisher Exact|||This is for the lower eyelid evaluation.||||.58
71719439|NCT02148263|142954484|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Extent||||.50
71719440|NCT02148263|142954484|SUPERIORITY|||||||0.76|||||||Fisher Exact|||Type||||.76
71719441|NCT02148263|142954484|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Depth||||.50
71719442|NCT02148263|142954485|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71719443|NCT02148263|142954486|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71719444|NCT00132301|142954488|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.4|TWO_SIDED|95.0|0.58|1.11||Log rank test stratified by site.|Log Rank|||||1.11|0.58|0.40
71719445|NCT02012218|142954489|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values were calculated according to testing a null hypothesis of zero mean change.|Mixed Models Analysis|This analysis was conducted using a mixed model repeated measures analysis on observed case data.||The null hypothesis of zero in mean change from baseline in MADRS total score at Week 6 was tested for each treatment group at significance level of 0.05 (2-sided).||||<0.0001
71719446|NCT02720523|142954504|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|14.3|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||51.0|14.3|<0.001
71719447|NCT02720523|142954504|SUPERIORITY||Response Rate Difference|40.8|||<|0.001|TWO_SIDED|95.0|23.5|58.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.1|23.5|<0.001
71719448|NCT02720523|142954504|SUPERIORITY||Response Rate Difference|37.1|||<|0.001|TWO_SIDED|95.0|19.4|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||54.9|19.4|<0.001
71719449|NCT02720523|142954504|OTHER|Cochran-Armitage test was conducted for demonstrating a dose response relationship.|||||<|0.001|||||||Cochran-Armitage test|||||||<0.001
71719450|NCT02720523|142954505|SUPERIORITY||Least Squares (LS) Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.693|-0.88|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-0.880|-1.693|<0.001
71829487|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.35||0.7598|ONE_SIDED|95.0|-0.83||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.83|0.7598
71829488|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.34||0.53|ONE_SIDED|95.0|-0.59||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.59|0.5300
71829489|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.3||0.7054|ONE_SIDED|95.0|-0.66||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.66|0.7054
71829490|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.45||0.8851|ONE_SIDED|95.0|-1.3||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.30|0.8851
71829491|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.7575|ONE_SIDED|95.0|-1.05||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.05|0.7575
71829492|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.39||0.4325|ONE_SIDED|95.0|-0.58||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.58|0.4325
71829493|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.8934|ONE_SIDED|95.0|-1.41||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.41|0.8934
71829494|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.47||0.5283|ONE_SIDED|95.0|-0.82||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.82|0.5283
71829495|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.41||0.49|ONE_SIDED|95.0|-0.68||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.68|0.4900
71829496|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.7465|ONE_SIDED|95.0|-1.2||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.20|0.7465
71719451|NCT02720523|142954505|SUPERIORITY||LS Mean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.005|-1.19|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.190|-2.005|<0.001
71829497|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.51||0.5848|ONE_SIDED|95.0|-0.95||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.95|0.5848
71829498|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.44||0.3178|ONE_SIDED|95.0|-0.53||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.53|0.3178
71829499|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.8169|ONE_SIDED|95.0|-1.34||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.34|0.8169
71829500|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.51||0.6727|ONE_SIDED|95.0|-1.08||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-1.08|0.6727
71829501|NCT00430300|143163123|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.5014|ONE_SIDED|95.0|-0.75||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-0.75|0.5014
71829502|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.3||0.7292|ONE_SIDED|95.0|-14.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-14.3|0.7292
71829503|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|6.2||0.2768|ONE_SIDED|95.0|-6.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-6.6|0.2768
71829504|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.4||0.3795|ONE_SIDED|95.0|-7.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-7.4|0.3795
71829505|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|7.7||0.7374|ONE_SIDED|95.0|-17.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.7|0.7374
71719452|NCT02720523|142954505|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001|TWO_SIDED|95.0|-2.027|-1.216|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo|||-1.216|-2.027|<0.001
71719453|NCT02720523|142954506|SUPERIORITY||LS Mean Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-0.465|-0.144|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.144|-0.465|<0.001
71719454|NCT02720523|142954506|SUPERIORITY||LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.505|-0.184|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.184|-0.505|<0.001
71719455|NCT02720523|142954506|SUPERIORITY||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.55|-0.229|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo|||-0.229|-0.550|<0.001
71719456|NCT02720523|142954507|SUPERIORITY||Response Rate Difference|24.5||||0.007|TWO_SIDED|95.0|7.3|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.7|7.3|0.007
71719457|NCT02720523|142954507|SUPERIORITY||Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|32.1|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||65.9|32.1|<0.001
71829506|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|7.6||0.7615|ONE_SIDED|95.0|-18.1||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.1|0.7615
71719458|NCT02720523|142954507|SUPERIORITY||Response Rate Difference|41.7|||<|0.001|TWO_SIDED|95.0|24.5|58.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||58.8|24.5|<0.001
71719459|NCT02720523|142954508|SUPERIORITY||Response Rate Difference|18.4||||0.004|TWO_SIDED|95.0|6.4|30.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.3|6.4|0.004
71719460|NCT02720523|142954508|SUPERIORITY||Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|18.7|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||46.6|18.7|<0.001
71719461|NCT02720523|142954508|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|12.9|39.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|12.9|<0.001
71719462|NCT02720523|142954509|SUPERIORITY||LS Mean Difference|4.33|||<|0.001|TWO_SIDED|95.0|2.1|6.57|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||6.57|2.10|<0.001
71719463|NCT02720523|142954509|SUPERIORITY||LS Mean Difference|3.5||||0.002|TWO_SIDED|95.0|1.25|5.75|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.75|1.25|0.002
71719464|NCT02720523|142954509|SUPERIORITY||LS Mean Difference|5.93|||<|0.001|TWO_SIDED|95.0|3.64|8.22|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||8.22|3.64|<0.001
71719465|NCT02720523|142954510|SUPERIORITY||Response Rate Difference|34.7|||<|0.001|TWO_SIDED|95.0|17.0|52.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||52.4|17.0|<0.001
71719466|NCT02720523|142954510|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|34.2|67.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||67.9|34.2|<0.001
71719467|NCT02720523|142954510|SUPERIORITY||Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.1|70.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||70.1|37.1|<0.001
71719468|NCT02720523|142954511|SUPERIORITY||Response Rate Difference|30.6|||<|0.001|TWO_SIDED|95.0|15.5|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||45.7|15.5|<0.001
71719469|NCT02720523|142954511|SUPERIORITY||Response Rate Difference|51.0|||<|0.001|TWO_SIDED|95.0|35.6|66.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||66.4|35.6|<0.001
71657066|NCT02944383|142831653|SUPERIORITY|||||||0.8483||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8483
71719470|NCT02720523|142954511|SUPERIORITY||Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|28.5|59.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||59.3|28.5|<0.001
71719471|NCT02720523|142954512|SUPERIORITY||Response Rate Difference|22.4||||0.006|TWO_SIDED|95.0|7.4|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||37.5|7.4|0.006
71719472|NCT02720523|142954512|SUPERIORITY||Response Rate Difference|16.3||||0.026|TWO_SIDED|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||30.6|2.1|0.026
71719473|NCT02720523|142954512|SUPERIORITY||Response Rate Difference|25.8||||0.002|TWO_SIDED|95.0|10.6|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo|||41.0|10.6|0.002
71719474|NCT02720523|142954513|SUPERIORITY||LS Mean Difference|2.66||||0.04|TWO_SIDED|95.0|0.12|5.2|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||5.20|0.12|0.040
71719475|NCT02720523|142954513|SUPERIORITY||LS Mean Difference|1.79||||0.169|TWO_SIDED|95.0|-0.77|4.35|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||4.35|-0.77|0.169
71829507|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|6.6||0.5811|ONE_SIDED|95.0|-12.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.4|0.5811
71829508|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|8.6||0.8939|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.8939
71829509|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|8.4||0.8117|ONE_SIDED|95.0|-21.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.6|0.8117
71829510|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|7.4||0.4393|ONE_SIDED|95.0|-11.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.2|0.4393
71829511|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.5|STANDARD_ERROR_OF_MEAN|9.8||0.8055|ONE_SIDED|95.0|-24.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.7|0.8055
71829512|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.5||0.6767|ONE_SIDED|95.0|-20.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-20.2|0.6767
71829513|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.4||0.407|ONE_SIDED|95.0|-12.0||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.0|0.4070
71829514|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|9.7||0.9705|ONE_SIDED|95.0|-34.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-34.7|0.9705
71719476|NCT02720523|142954513|SUPERIORITY||LS Mean Difference|0.85||||0.516|TWO_SIDED|95.0|-1.73|3.43|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||3.43|-1.73|0.516
71719477|NCT02720523|142954514|SUPERIORITY||LS Mean Difference|-2.54||||0.021|TWO_SIDED|95.0|-4.68|-0.39|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-0.39|-4.68|0.021
71719478|NCT02720523|142954514|SUPERIORITY||LS Mean Difference|-2.06||||0.08|TWO_SIDED|95.0|-4.36|0.25|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.25|-4.36|0.080
71829515|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|9.4||0.8249|ONE_SIDED|95.0|-24.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.6|0.8249
71829516|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|8.3||0.9345|ONE_SIDED|95.0|-26.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.6|0.9345
71829517|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|11.0||0.7384|ONE_SIDED|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-25.3|0.7384
71829518|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|10.7||0.5239|ONE_SIDED|95.0|-18.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-18.4|0.5239
71829519|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|9.4||0.417|ONE_SIDED|95.0|-13.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.7|0.4170
71719479|NCT02720523|142954514|SUPERIORITY||LS Mean Difference|-1.56||||0.22|TWO_SIDED|95.0|-4.06|0.94|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||0.94|-4.06|0.220
71829520|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|10.3||0.7695|ONE_SIDED|95.0|-24.8||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-24.8|0.7695
71719480|NCT02720523|142954515|SUPERIORITY||LS Mean Difference|-1.81|||<|0.001|TWO_SIDED|95.0|-2.57|-1.04|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.04|-2.57|<0.001
71719481|NCT02720523|142954515|SUPERIORITY||LS Mean Difference|-1.82|||<|0.001|TWO_SIDED|95.0|-2.59|-1.05|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.05|-2.59|<0.001
71719482|NCT02720523|142954515|SUPERIORITY||LS Mean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.73|-1.18|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo|||-1.18|-2.73|<0.001
71887442|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|1.05|||<|0.001|TWO_SIDED|95.0|0.45|2.44||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.74|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline||2.44|0.45|<0.001
71768777|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0461|TWO_SIDED|90.0|1.1|2.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 5.||2.73|1.10|0.0461
71768778|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.14|TWO_SIDED|90.0|0.41|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 6.||1.05|0.41|0.1400
71768779|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.0002|TWO_SIDED|90.0|1.74|4.21|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 6.||4.21|1.74|0.0002
71768780|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9596|TWO_SIDED|90.0|0.59|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 8.||1.64|0.59|0.9596
71768781|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24||||0|TWO_SIDED|90.0|2.01|5.23|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 8.||5.23|2.01|0.0000
71768782|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.653|TWO_SIDED|90.0|0.69|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 10.||1.93|0.69|0.6530
71829521|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|10.1||0.4566|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4566
71768783|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.48||||0|TWO_SIDED|90.0|2.11|5.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 10.||5.73|2.11|0.0000
71719483|NCT02340169|142954516|OTHER||||||||||||||||||Adrenal suppression rates in the evaluable population were 35% (21 out of 60), 43.3% (13 out of 30) and 20% (2 out of 10) in Cohorts 1, 2 a nd 3, respectively.|||
71719484|NCT00473889|142954570|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Log Rank|Disease stage and bevacizumab eligibility are the stratification factors in the stratified log rank test.||||||0.992
71829522|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|8.9||0.3535|ONE_SIDED|95.0|-11.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.4|0.3535
71829523|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|11.1||0.8598|ONE_SIDED|95.0|-30.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.7|0.8598
71719485|NCT00473889|142954571|SUPERIORITY_OR_OTHER|||||||0.862||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Finkelstein's Interval Censored Method|Disease stage and bevacizumab eligibility are the stratification factors in the Finkelstein's Interval Censored Method Model.||||||0.862
71719486|NCT00473889|142954572|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Miettinen and Nurminen|Disease stage and bevacizumab eligibility are the stratification factors in the stratified Miettinen and Nurmimen method.||||||0.899
71719487|NCT03783962|142954575|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||.003
71719488|NCT03783962|142954576|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||||||.97
71719489|NCT03783962|142954577|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
71719490|NCT03783962|142954577|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719491|NCT03783962|142954577|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719492|NCT03783962|142954578|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||.18
71719493|NCT03783962|142954578|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
71768784|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.8844|TWO_SIDED|90.0|0.23|3.48|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 1.||3.48|0.23|0.8844
71768785|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.7425|TWO_SIDED|90.0|0.36|4.68|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 1.||4.68|0.36|0.7425
71768786|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8355|TWO_SIDED|90.0|0.39|2.07|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 2.||2.07|0.39|0.8355
71768787|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.1786|TWO_SIDED|90.0|0.86|4.32|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 2.||4.32|0.86|0.1786
71768788|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0835|TWO_SIDED|90.0|0.26|0.97|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 3.||0.97|0.26|0.0835
71719494|NCT03783962|142954578|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
71719495|NCT03783962|142954579|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||.40
71719496|NCT03783962|142954579|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719497|NCT03783962|142954579|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719498|NCT03783962|142954580|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
71719499|NCT03783962|142954580|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719500|NCT03783962|142954580|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719501|NCT03783962|142954581|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||.26
71768789|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8558|TWO_SIDED|90.0|0.58|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 3.||1.98|0.58|0.8558
71768790|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.0067|TWO_SIDED|90.0|0.2|0.67|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 4.||0.67|0.20|0.0067
71719502|NCT03783962|142954581|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|||||||.41
71719503|NCT03783962|142954581|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
71719504|NCT03783962|142954582|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||.03
71829524|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|10.9||0.8005|ONE_SIDED|95.0|-27.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.4|0.8005
71719505|NCT03783962|142954582|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||.02
71719506|NCT03783962|142954582|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71719507|NCT03783962|142954583|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||.58
71719508|NCT03783962|142954583|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71719509|NCT03783962|142954583|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||.01
71719510|NCT03783962|142954584|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
71768791|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.6647|TWO_SIDED|90.0|0.67|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 4.||1.98|0.67|0.6647
71768792|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9553|TWO_SIDED|90.0|0.55|1.74|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 5.||1.74|0.55|0.9553
71719511|NCT03783962|142954585|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71719512|NCT03458325|142954586|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||-11,802.70|-22,187.90|<0.0001
71719513|NCT03458325|142954587|SUPERIORITY||Percentage Difference|-6.4||||0.6765|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.6765
71719514|NCT03458325|142954588|SUPERIORITY||Mean Difference (Net)|5.3||||0.5856|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||0.5856
71719515|NCT03458325|142954589|SUPERIORITY||Mean Difference (Net)|-1.9||||1|TWO_SIDED||||||Fisher Exact|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||1.000
71719516|NCT03458325|142954590|SUPERIORITY||Mean Difference (Net)|65.1|||<|0.0001|TWO_SIDED||||||Chi-squared|||"The comparator arm was populated with claims data for patients who presented to the emergency department for worsening HF and were admitted to the hospital for ≤ 72 hours for the treatment of HF. The filter was further strengthened by analyzing diagnostic codes and resource utilization during their hospital stay to exclude hospitalizations other than Heart Failure.~Each subject from the Furoscix group was matched to controls in ratios ranging from 1:1 to 4:1."||||<0.0001
71719517|NCT03458325|142954591|SUPERIORITY||Mean Difference (Net)|12.8||||0.0443|TWO_SIDED|95.0|0.4|25.3|||t-test, 2 sided|P-value was obtained from the paired t-test statistic.||Analysis for Summary Score||25.3|0.4|0.0443
71719518|NCT03458325|142954592|SUPERIORITY|Statistical Analysis for the mean change in NT-proBNP over 30 days|Mean Difference (Final Values)|-122.6||||0.5133|TWO_SIDED|95.0|-525.8|280.5|||t-test, 2 sided|||||280.5|-525.8|0.5133
71719519|NCT03458325|142954592|SUPERIORITY||Mean Difference (Final Values)|-719.9||||0.042|TWO_SIDED|95.0|-1406.5|-33.2|||t-test, 2 sided|||Statistical Analysis for mean change in BNP over 30 days||-33.2|-1406.5|0.0420
71719520|NCT02956746|142954596|OTHER|||||||0.4187||||||threshold for significance p-values \< 0.05|ANOVA|||||||0.4187
71719521|NCT02621476|142954617|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71719522|NCT00131352|142954660|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.||||||0.047
71719523|NCT00131352|142954661|SUPERIORITY_OR_OTHER|||||||0.064||95.0|||||ANCOVA|||||||0.064
71719524|NCT00131352|142954662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.022|TWO_SIDED|95.0|0.35|0.92|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.||0.92|0.35|0.022
71719525|NCT00131352|142954663|SUPERIORITY_OR_OTHER|||||||0.679||95.0|||||ANCOVA|||||||0.679
71719526|NCT00131352|142954664|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||||||0.266
71719527|NCT00131352|142954665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.005|TWO_SIDED|95.0|0.31|0.82|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.||0.82|0.31|0.005
71768793|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.004||90.0|1.5|4.42|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 5.||4.42|1.50|0.0040
71768794|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6327|TWO_SIDED|90.0|0.52|1.43|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 6.||1.43|0.52|0.6327
71768795|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0027|TWO_SIDED|90.0|1.47|3.79|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 6.||3.79|1.47|0.0027
71768796|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3961|TWO_SIDED|90.0|0.45|1.29|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 8.||1.29|0.45|0.3961
71768797|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0298|TWO_SIDED|90.0|1.17|3.06|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 8.||3.06|1.17|0.0298
71768798|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.8826|TWO_SIDED|90.0|0.56|1.61|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 10.||1.61|0.56|0.8826
71768799|NCT00420641|143038024|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0022|TWO_SIDED|90.0|1.52|4.05|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 10.||4.05|1.52|0.0022
71719528|NCT00131352|142954666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.025|TWO_SIDED|95.0|0.34|0.93|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.||0.93|0.34|0.025
71719529|NCT00131352|142954667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.156|TWO_SIDED|95.0|0.41|1.16|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.||1.16|0.41|0.156
71768800|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.5072|TWO_SIDED|90.0|0.22|1.89|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 1.||1.89|0.22|0.5072
71768801|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6886|TWO_SIDED|90.0|0.52|2.93|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 1.||2.93|0.52|0.6886
71768802|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8664|TWO_SIDED|90.0|0.56|2.04|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 2.||2.04|0.56|0.8664
71768803|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2897|TWO_SIDED|90.0|0.8|2.79|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 2.||2.79|0.80|0.2897
71768804|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.2474|TWO_SIDED|90.0|0.39|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 3.||1.18|0.39|0.2474
71768805|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.2007|TWO_SIDED|90.0|0.89|2.47|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 3.||2.47|0.89|0.2007
71768806|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.0214|TWO_SIDED|90.0|0.29|0.82|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 4.||0.82|0.29|0.0214
71719530|NCT01194219|142954668|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.8|||<|0.0001|TWO_SIDED|95.0|23.1|32.5|||Chi-squared|||||32.5|23.1|<0.0001
71719531|NCT01194219|142954669|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|21.9|||Chi-squared|||||21.9|13.7|<0.0001
71719532|NCT01194219|142954670|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-40.78|||<|0.0001|TWO_SIDED|95.0|-46.34|-35.21|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-35.21|-46.34|<0.0001
71719533|NCT01194219|142954671|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-30.6|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-30.6|-39.9|<0.0001
71768807|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.2368|TWO_SIDED|90.0|0.88|2.23|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 4.||2.23|0.88|0.2368
71768808|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.987|TWO_SIDED|90.0|0.63|1.59|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 5.||1.59|0.63|0.9870
71768809|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.0193|TWO_SIDED|90.0|1.21|3.0|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 5.||3.00|1.21|0.0193
71829525|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|9.6||0.3441|ONE_SIDED|95.0|-12.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-12.2|0.3441
71719534|NCT01194219|142954672|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|35.7|47.7|||Chi-squared|||||47.7|35.7|<0.0001
71719535|NCT01194219|142954673|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-24.2|||<|0.0001|TWO_SIDED|95.0|-28.7|-19.8|||ANOVA|Based on an analysis of variance model for the change from baseline at Week 16, with treatment group as a factor (an ANOVA model).||||-19.8|-28.7|<0.0001
71719536|NCT01194219|142954674|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.4|-3.6|||ANOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor, the baseline value, and the treatment by baseline interaction term as covariates.|||-3.6|-5.4|<0.0001
71719537|NCT01194219|142954675|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.08|||<|0.0001|TWO_SIDED|95.0|1.81|4.35|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.35|1.81|<0.0001
71719538|NCT01194219|142954676|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.7|||<|0.0001|TWO_SIDED|95.0|12.8|20.7|||Chi-squared|||||20.7|12.8|<0.0001
71719539|NCT01194219|142954677|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.649|||<|0.0001|TWO_SIDED|95.0|1.768|3.969|||Log Rank|||||3.969|1.768|<0.0001
71719540|NCT04474197|142954694|SUPERIORITY||Least Squares (LS) Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.5|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.5|<0.0001
71719541|NCT04474197|142954694|SUPERIORITY||LS Mean Difference|2.3|||<|0.0001|TWO_SIDED|95.0|1.6|3.1|||Mixed-effects Model for Repeated Measure|||||3.1|1.6|<0.0001
71719542|NCT04474197|142954694|SUPERIORITY||LS Mean Difference|2.2|||<|0.0001|TWO_SIDED|95.0|1.5|2.9|||Mixed-effects Model for Repeated Measure|||||2.9|1.5|<0.0001
71719543|NCT04474197|142954696|SUPERIORITY||LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.6|||Mixed-effects Model for Repeated Measure|||||4.6|2.4|<0.0001
71719544|NCT04474197|142954696|SUPERIORITY||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.9|4.0|||Mixed-effects Model for Repeated Measure|||||4.0|1.9|<0.0001
71719545|NCT04474197|142954696|SUPERIORITY||LS Mean Difference|2.7|||<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed-effects Model for Repeated Measure|||||3.7|1.8|<0.0001
71719546|NCT00635349|142954705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)|Mean Difference (Final Values)|1.81||||0.4258|ONE_SIDED|97.5|-6.31||||t-test, 1 sided||||||-6.31|0.4258
71719547|NCT00635349|142954706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0628|ONE_SIDED|97.5|-1.41||||t-test, 1 sided||||||-1.41|0.0628
71719548|NCT00635349|142954707|SUPERIORITY_OR_OTHER|||||||0.0131||||||Day 29: p-value was calculated by fisher exact test|Fisher Exact|||||||0.0131
71719549|NCT00635349|142954707|SUPERIORITY_OR_OTHER|||||||0.9834||||||Day 57; p-value was calculated by Chi-squared test|Chi-squared|||||||0.9834
71768810|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8351|TWO_SIDED|90.0|0.59|1.5|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 6.||1.50|0.59|0.8351
71719550|NCT00635349|142954707|SUPERIORITY_OR_OTHER|||||||0.1131||||||Day 85; p-value was calculated by Chi-squared test|Chi-squared|||||||0.1131
71719551|NCT03951766|142954753|SUPERIORITY||Mean Difference (Final Values)|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.1||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||||-1.1|-1.9|<.0001
71719552|NCT03951766|142954754|SUPERIORITY||Median Difference (Final Values)|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.7|-17.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-17.1|-32.7|<.0001
71719553|NCT03951766|142954755|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.06|TWO_SIDED|95.0|0.0|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||PANAS positive affect||0.4|-0.0|0.06
71719554|NCT03951766|142954755|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.36|TWO_SIDED|95.0|-0.4|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||PANAS negative affect||0.1|-0.4|0.36
71719555|NCT03951766|142954756|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.1627|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1627
71719556|NCT03951766|142954757|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.62|TWO_SIDED|95.0|-3.8|6.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - past week||6.3|-3.8|0.62
71719557|NCT03951766|142954757|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.83|TWO_SIDED|95.0|-5.4|4.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||Single-item - right now||4.4|-5.4|0.83
71719558|NCT03951766|142954758|SUPERIORITY||Mean Difference (Final Values)|13.1|||<|0.0001|TWO_SIDED|95.0|7.6|18.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||SEQ-12 - Internal||18.7|7.6|<.0001
71719559|NCT03951766|142954758|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.0001|TWO_SIDED|95.0|6.1|16.1|||t-test, 2 sided|||SEQ-12 - External||16.1|6.1|<.0001
71719560|NCT03951766|142954759|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.0126|TWO_SIDED|95.0|1.2|9.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||9.8|1.2|0.0126
71719561|NCT03951766|142954760|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.0053|TWO_SIDED|95.0|-11.1|-2.0||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.0|-11.1|0.0053
71768811|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.0001|TWO_SIDED|90.0|1.9|4.77|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 6.||4.77|1.90|0.0001
71768812|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.751|TWO_SIDED|90.0|0.67|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 8.||1.80|0.67|0.7510
71768813|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.0029|TWO_SIDED|90.0|1.47|3.8|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 8.||3.80|1.47|0.0029
71719562|NCT03951766|142954761|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||ATS - Adverse Effects||0.2|-0.1|0.76
71719563|NCT03951766|142954761|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.5||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Psychoactive Benefits||-0.5|-1.0|<.0001
71719564|NCT03951766|142954761|SUPERIORITY||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3||The a priori threshold for statistical significance was alpha=.05. We did not adjust for multiple comparisons, because this was a secondary outcome. The p-value is for a planned specific comparison of week 6 to baseline.|t-test, 2 sided|||ATS - Pleasure||-0.3|-0.8|<.0001
71719565|NCT03951766|142954762|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.25|TWO_SIDED|95.0|-0.3|0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.1|-0.3|0.25
71719566|NCT03951766|142954763|SUPERIORITY|DBI - Positive Experiences|Mean Difference (Final Values)|-20.7|||<|0.0001|TWO_SIDED|95.0|-27.2|-14.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-14.3|-27.2|<.0001
71719567|NCT03951766|142954763|SUPERIORITY|DBI - Negative Experiences|Mean Difference (Final Values)|-2.9||||0.27|TWO_SIDED|95.0|-8.1|2.3||"We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6."|t-test, 2 sided|||||2.3|-8.1|0.27
71719568|NCT03951766|142954764|SUPERIORITY|Pros of Being Smoke-Free|Mean Difference (Final Values)|-9.1||||0.009|TWO_SIDED|95.0|-15.9|-2.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-2.3|-15.9|0.009
71719569|NCT03951766|142954764|SUPERIORITY|Cons of Quitting|Mean Difference (Final Values)|-5.1||||0.25|TWO_SIDED|95.0|-13.7|3.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||3.6|-13.7|0.25
71719570|NCT03951766|142954765|SUPERIORITY|PSS total scores|Mean Difference (Final Values)|-2.4||||0.0069|TWO_SIDED|95.0|-4.1|-0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.7|-4.1|0.0069
71719571|NCT03951766|142954765|SUPERIORITY|PSS - Perceived Helplessness|Mean Difference (Final Values)|-0.3||||0.0043|TWO_SIDED|95.0|-0.5|-0.1||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.1|-0.5|0.0043
71719572|NCT03951766|142954765|SUPERIORITY|PSS - Perceived Self-Efficacy|Mean Difference (Final Values)|0.1||||0.1953|TWO_SIDED|95.0|-0.1|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.1|0.1953
71719573|NCT03951766|142954766|SUPERIORITY|Brief COPE Self-distraction|Mean Difference (Final Values)|0.4||||0.087|TWO_SIDED|95.0|-0.1|0.8||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.8|-0.1|0.087
71719574|NCT03951766|142954766|SUPERIORITY|Brief COPE active coping|Mean Difference (Final Values)|-0.209||||0.2866|TWO_SIDED|95.0|-0.6|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.6|0.2866
71829526|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|6.9||0.4436|ONE_SIDED|95.0|-10.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-10.5|0.4436
71719575|NCT03951766|142954766|SUPERIORITY|Brief COPE denial|Mean Difference (Final Values)|0.0||||0.9296|TWO_SIDED|95.0|-0.4|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.4|-0.4|0.9296
71719576|NCT03951766|142954766|SUPERIORITY|Brief COPE substance use|Mean Difference (Final Values)|-0.1||||0.6599|TWO_SIDED|95.0|-0.5|0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.3|-0.5|0.6599
71719577|NCT03951766|142954766|SUPERIORITY|Brief COPE use of emotional support|Mean Difference (Final Values)|0.3||||0.2315|TWO_SIDED|95.0|-0.2|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6|t-test, 2 sided|||||0.7|-0.2|0.2315
71719578|NCT03951766|142954766|SUPERIORITY|Brief COPE use of instrumental support|Mean Difference (Final Values)|0.1||||0.6183|TWO_SIDED|95.0|-0.3|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.3|0.6183
71768814|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1707|TWO_SIDED|90.0|0.92|2.55|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 10.||2.55|0.92|0.1707
71829527|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.8||0.7238|ONE_SIDED|95.0|-15.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.5|0.7238
71719579|NCT03951766|142954766|SUPERIORITY|Brief COPE behavioral disengagement|Mean Difference (Final Values)|0.3||||0.2037|TWO_SIDED|95.0|-0.1|0.7||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.7|-0.1|0.2037
71719580|NCT03951766|142954766|SUPERIORITY|Brief COPE venting|Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-0.9|0.0060
71719581|NCT03951766|142954766|SUPERIORITY|Brief COPE positive reframing|Mean Difference (Final Values)|-0.2||||0.3045|TWO_SIDED|95.0|-0.7|0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.2|-0.7|0.3045
71719582|NCT03951766|142954766|SUPERIORITY|Brief COPE planning|Mean Difference (Final Values)|-0.6||||0.0029|TWO_SIDED|95.0|-1.0|-0.2||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.2|-1.0|0.0029
71719583|NCT03951766|142954766|SUPERIORITY|Brief COPE humor|Mean Difference (Final Values)|0.0||||0.8274|TWO_SIDED|95.0|-0.5|0.4||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.4|-0.5|0.8274
71719584|NCT03951766|142954766|SUPERIORITY|Brief COPE acceptance|Mean Difference (Final Values)|0.4||||0.0349|TWO_SIDED|95.0|0.0|0.9||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.9|0.0|0.0349
71719585|NCT03951766|142954766|SUPERIORITY|Brief COPE religion|Mean Difference (Final Values)|0.2||||0.3451|TWO_SIDED|95.0|-0.2|0.6||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||0.6|-0.2|0.3451
71719586|NCT03951766|142954766|SUPERIORITY|Brief COPE self-blame|Mean Difference (Final Values)|-0.8||||0.0006|TWO_SIDED|95.0|-1.2|-0.3||We used hierarchical linear mixed models with maximum likelihood estimation to handle missing data, then used a planned, pairwise comparison to test for within-person changes between baseline and week 6.|t-test, 2 sided|||||-0.3|-1.2|0.0006
71719587|NCT00295646|142954805|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|1.1||||0.59|TWO_SIDED|95.0|0.78|1.53||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter disease-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||1.53|0.78|0.59
71657067|NCT02944383|142831653|SUPERIORITY|||||||0.0008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0008
71719588|NCT00295646|142954806|SUPERIORITY|A two-sided significance level of 2.5% was used in this 2x2 factorial design of two primary endpoints according to the Bonferroni-Holm adjustment to control multiplicity.|Cox Proportional Hazard|0.64||||0.01|TWO_SIDED|95.0|0.46|0.91||Two-sided significance level of 2.5%, with the application of the Bonferroni-Holm adjustment for multiple comparisons|Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of disease-free survival. Disease-free survival (DFS) is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death from any cause.||0.91|0.46|0.01
71719589|NCT00295646|142954807|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.11||||0.53|TWO_SIDED|95.0|0.8|1.56|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter recurrence-free time for arimidex relative to tamoxifen.|To determine the effect of arimidex (AZ and AC) compared to tamoxifen (TZ and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.||1.56|0.80|0.53
71719590|NCT00295646|142954808|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.65||||0.01|TWO_SIDED|95.0|0.46|0.92|||Log Rank|||To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of recurrence-free survival. Recurrence-free survival is defined as the time from randomization to the first occurrence of a local or regional recurrence, cancer in the contralateral breast, distant metastasis, second primary carcinoma, or death related to breast cancer.|From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer recurrence-free time for Zoledronic Acid relative to no Zoledronic Acid.|0.92|0.46|0.01
71719591|NCT00295646|142954809|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|1.8||||0.07|TWO_SIDED|95.0|0.96|3.38|||Log Rank||From the Cox Proportional hazard model with endocrine treatment fitted as a covariate. A hazard ratio \> 1.0 indicates a higher average event rate and a shorter survival time for arimidex relative to tamoxifen.|To determine the effect of anastrozole (AZ and AC) compared to tamoxifen (TZ and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||3.38|0.96|0.07
71768815|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.0001|TWO_SIDED|90.0|1.99|5.36|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 10.||5.36|1.99|0.0001
71719592|NCT00295646|142954810|SUPERIORITY|No multiplicity adjustment was applied.|Cox Proportional Hazard|0.6||||0.1|TWO_SIDED|95.0|0.32|1.11|||Log Rank||From the Cox Proportional hazard model with Zoledronic Acid treatment fitted as a covariate. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival time for Zoledronic Acid relative to no Zoledronic Acid.|To determine the effect of Zoledronic Acid (AZ and TZ) compared to no Zoledronic Acid (AC and TC) in terms of overall survival. Overall survival is defined as the time from randomization to death from any cause.||1.11|0.32|0.10
71719593|NCT02626156|142954811|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.091|TWO_SIDED|95.0|-0.02|0.3|||Chi-squared||Asymptotic standard error was used|||0.3|-0.02|0.091
71719594|NCT03579693|142954821|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.33|TWO_SIDED|95.0|-0.43|1.31|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.31|-0.43|0.33
71719595|NCT03579693|142954821|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.93|TWO_SIDED|95.0|-0.9|0.82|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.82|-0.90|0.93
71719596|NCT03579693|142954822|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.05|TWO_SIDED|95.0|-3.47|0.0|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||0.00|-3.47|0.050
71719597|NCT03579693|142954822|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.47|TWO_SIDED|95.0|-2.28|1.05|||Mixed Models Analysis||Interpretation of mean difference is for a typical participant, i.e. random effect of 0.|||1.05|-2.28|0.47
71719598|NCT03083665|142954855|SUPERIORITY||Percent reduction over Placebo|24.5||||0.0005|TWO_SIDED|95.0|11.7|35.5||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||35.5|11.7|0.0005
71829528|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|6.0||0.5743|ONE_SIDED|95.0|-11.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-11.1|0.5743
71829529|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|9.8||0.619|ONE_SIDED|95.0|-19.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.3|0.6190
71657068|NCT02944383|142831653|SUPERIORITY|||||||0.0938||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0938
71829530|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|9.7||0.9473|ONE_SIDED|95.0|-32.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.1|0.9473
71719599|NCT03083665|142954855|SUPERIORITY||Percent reduction over Placebo|33.4|||<|0.0001|TWO_SIDED|95.0|21.9|43.1||Statistical testing with control of Type I error rate were based on a Hochberg multiple comparison procedure.|ANCOVA||Based on ANCOVA with log-transformed \[log(x+1)\] Treatment Period 28-day adjusted partial seizure frequency.|||43.1|21.9|<0.0001
71719600|NCT01467466|142954865|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7|TWO_SIDED|95.0|0.73|1.24|||Wald's Chi-Square|||||1.24|0.73|0.70
71890232|NCT01795547|143302096|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.007||||0.561|TWO_SIDED|95.0|-2.402|4.417||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||4.417|-2.402|0.561
71719601|NCT01467466|142954866|SUPERIORITY||Odds Ratio (OR)|1.02||||0.86|TWO_SIDED|95.0|0.78|1.34|||Wald's Chi-Square|||||1.34|0.78|0.86
71719602|NCT02622295|142954867|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71719603|NCT02622295|142954868|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71719604|NCT02622295|142954869|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71719605|NCT02622295|142954870|SUPERIORITY|||||||0.467|||||||ANOVA|||||||0.467
71719606|NCT02622295|142954871|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71719607|NCT02622295|142954872|SUPERIORITY|||||||0.932|||||||ANOVA|||||||0.932
71719608|NCT02622295|142954873|SUPERIORITY|||||||0.326|||||||ANOVA|||||||0.326
71719609|NCT02622295|142954874|SUPERIORITY|||||||0.673|||||||ANOVA|||||||0.673
71719610|NCT02622295|142954875|SUPERIORITY|||||||0.539|||||||ANOVA|||||||0.539
71719611|NCT02622295|142954876|SUPERIORITY|||||||0.155|||||||ANOVA|||||||0.155
71719612|NCT02622295|142954877|SUPERIORITY|||||||0.164|||||||ANOVA|||||||0.164
71719613|NCT02622295|142954878|SUPERIORITY|||||||0.493|||||||ANOVA|||||||0.493
71719614|NCT02622295|142954879|SUPERIORITY|||||||0.458|||||||ANOVA|||||||0.458
71719615|NCT01144416|142954889|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in percentage vital pregnancy|-3.0|||||TWO_SIDED|95.0|-7.4|1.4|||generalized linear model|The estimated difference in percentage vital pregnancy was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.4|-7.4|
71719616|NCT01144416|142954890|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -3 oocytes.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.2|||ANOVA|The estimated difference in number of oocytes retrieved was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs) and center.||||1.2|-0.2|
71719617|NCT01144416|142954891|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The pre-defined non-inferiority margin was -8%|Difference in Live Birth Rates|-2.3|||||TWO_SIDED|95.0|-6.5|1.9|||generalized linear model|The estimated difference in live birth rate was adjusted for age class as stratified (≤38 yrs vs. \>38 yrs)||||1.9|-6.5|
71719618|NCT01144416|142954892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Fisher Exact|||||||0.30
71768816|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.205|TWO_SIDED|90.0|0.05|1.48|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 1.||1.48|0.05|0.2050
71829531|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|8.5||0.8014|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.8014
71829532|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|8.6||0.7929|ONE_SIDED|95.0|-21.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.5|0.7929
71887443|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|0.48|||<|0.01|TWO_SIDED|95.0|0.13|1.78||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.59|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||1.78|0.13|<0.01
71719619|NCT01144416|142954893|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71719620|NCT00480740|142954894|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state \[dexmedetomidine + sevoflurane\]-baseline \[sevoflurane0\]/baseline \[sevoflurane\]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.||||||0.05||95.0||||The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.|t-test, 2 sided|||||||0.05
71719621|NCT02881775|142954913|SUPERIORITY|||||||0.9994||||||The threshold for significance was P \<.05|ANOVA|"Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors.~Degrees of freedom (DF) = 34.1"||Comparison of CAR BL Change (treatment by time)||||.9994
71719622|NCT02881775|142954914|SUPERIORITY|||||||0.9768||||||The threshold for statistical significance was p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of MVIC BL Change (treatment by time)||||.9768
71829533|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|8.4||0.9963|ONE_SIDED|95.0|-37.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-37.3|0.9963
71829534|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|7.4||0.7387|ONE_SIDED|95.0|-17.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-17.1|0.7387
71719623|NCT02881775|142954915|SUPERIORITY|||||||0.444||||||threshold for statistical significance is p \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 43.1||Comparison of NPRS BL Change (treatment by time)||||0.4440
71719624|NCT02881775|142954916|SUPERIORITY|||||||0.6608||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||PPT BL Change (treatment by time)||||.6608
71719625|NCT02881775|142954917|SUPERIORITY|||||||0.7706||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of TUG BL Change (treatment by time)||||.7706
71719626|NCT02881775|142954918|SUPERIORITY|||||||0.3665||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of AMT-MEP BL Change (treatment by time)||||.3665
71719627|NCT02881775|142954919|SUPERIORITY|||||||0.3889||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of SICI BL Change (treatment by time)||||.3889
71719628|NCT02881775|142954920|SUPERIORITY|||||||0.2192||||||Threshold for statistical significance is P \< .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of ICF BL Change (treatment by time)||||.2192
71719629|NCT03541499|142954939|SUPERIORITY|||||||0.807|||||||Barnard's exact test|||At any time point||||0.807
71719630|NCT03541499|142954939|SUPERIORITY|||||||0.043|||||||Barnard's exact test|||At any time point||||0.043
71719631|NCT03541499|142954940|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
71719632|NCT03541499|142954940|SUPERIORITY|||||||0.301|||||||Barnard's exact test|||Any time point||||0.301
71719633|NCT03541499|142954941|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
71719634|NCT03541499|142954941|SUPERIORITY|||||||0.009|||||||Barnard's exact test|||Any time point||||0.009
71829535|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|8.4||0.6286|ONE_SIDED|95.0|-16.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.8|0.6286
71890233|NCT01795547|143302097|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.695||||0.095|TWO_SIDED|95.0|-1.511|0.121||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||||0.121|-1.511|0.095
71719635|NCT03541499|142954943|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgA, any time point||||0.526
71719636|NCT03541499|142954943|SUPERIORITY|||||||0.1|||||||Barnard's exact test|||IgA, any time point||||0.100
71719637|NCT03541499|142954943|SUPERIORITY|||||||0.055|||||||Barnard's exact test|||IgG, any time point||||0.055
71719638|NCT03541499|142954943|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
71719639|NCT03541499|142954944|SUPERIORITY|||||||0.174|||||||Barnard's exact test|||IgA, any time point||||0.174
71719640|NCT03541499|142954944|SUPERIORITY|||||||0.006|||||||Barnard's exact test|||IgA, any time point||||0.006
71719641|NCT03541499|142954944|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||IgG, any time point||||0.745
71719642|NCT03541499|142954944|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgG, any time point||||0.023
71719643|NCT03541499|142954950|SUPERIORITY|||||||0.023|||||||Barnard's exact test|||IgA, any time point||||0.023
71719644|NCT03541499|142954950|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgA, any time point||||0.142
71719645|NCT03541499|142954950|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
71719646|NCT03541499|142954950|SUPERIORITY|||||||0.142|||||||Barnard's exact test|||IgG, any time point||||0.142
71719647|NCT03541499|142954951|SUPERIORITY|||||||0.836|||||||Barnard's exact test|||IgA, any time point||||0.836
71719648|NCT03541499|142954951|SUPERIORITY|||||||1|||||||Barnard's exact test|||IgA, any time point||||1.000
71719649|NCT03541499|142954951|SUPERIORITY|||||||0.526|||||||Barnard's exact test|||IgG, any time point||||0.526
71829536|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|8.3||0.9538|ONE_SIDED|95.0|-27.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-27.8|0.9538
71719650|NCT03541499|142954951|SUPERIORITY|||||||0.119|||||||Barnard's exact test|||IgG, any time point||||0.119
71719651|NCT03541499|142954952|SUPERIORITY|||||||0.271|||||||Barnard's exact test|||Any time point||||0.271
71719652|NCT03541499|142954952|SUPERIORITY|||||||0.226|||||||Barnard's exact test|||Any time point||||0.226
71719653|NCT03541499|142954953|SUPERIORITY|||||||0.783|||||||Barnard's exact test|||Any time point||||0.783
71719654|NCT03541499|142954953|SUPERIORITY|||||||0.001|||||||Barnard's exact test|||Any time point||||0.001
71719655|NCT03541499|142954954|SUPERIORITY|||||||0.745|||||||Barnard's exact test|||Any time point||||0.745
71719656|NCT03541499|142954954|SUPERIORITY|||||||0.068|||||||Barnard's exact test|||Any time point||||0.068
71719657|NCT03541499|142954955|SUPERIORITY|||||||0.585|||||||Barnard's exact test|||Any time point||||0.585
71719658|NCT03541499|142954955|SUPERIORITY|||||||1|||||||Barnard's exact test|||Any time point||||1.000
71719659|NCT02131662|142954957|SUPERIORITY_OR_OTHER||Percentage difference|58.28|||||TWO_SIDED|95.0|44.55|70.94||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||70.94|44.55|
71719660|NCT02131662|142954957|SUPERIORITY_OR_OTHER||Percentage difference|52.37|||||TWO_SIDED|95.0|38.8|65.42||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||65.42|38.8|
71719661|NCT02131662|142954957|SUPERIORITY_OR_OTHER||Percentage difference|54.01|||||TWO_SIDED|95.0|40.41|66.95||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||66.95|40.41|
71719662|NCT02131662|142954957|SUPERIORITY_OR_OTHER||Percentage difference|28.28|||||TWO_SIDED|95.0|15.92|41.5||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.||41.5|15.92|
71719663|NCT01402869|142954970|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||LSD post hoc test was used for multiple group comparisons. P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in peak methemoglobin blood levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
71829537|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|7.3||0.5701|ONE_SIDED|95.0|-13.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-13.4|0.5701
71719664|NCT01402869|142954970|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71719665|NCT01402869|142954970|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71719666|NCT01402869|142954970|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.89||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.89
71719667|NCT01402869|142954971|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001|||||||ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in the time frame to peak methemoglobin levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
71719668|NCT01402869|142954971|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.43||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.43
71719669|NCT01402869|142954971|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71719670|NCT01402869|142954971|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71719671|NCT01402869|142954972|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||95.0||||P\<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in delta methemoglobin blood levels following the administration prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.||||<.001
71719672|NCT01402869|142954972|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71719673|NCT01402869|142954972|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||<|0.001||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||<.001
71719674|NCT01402869|142954972|NON_INFERIORITY_OR_EQUIVALENCE|Power of 80|||||=|0.92||||||P\<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison||||=.92
71719675|NCT01740687|142954973|OTHER||95% upper Bayesian credible interval|1.23|||||||||||||%|predetermined study success threshold of 2.1% at 1 year||||
71719676|NCT01740687|142954974|OTHER||95% upper Bayesian credible interval|1.33|||||||||||||%|predetermined study success threshold of 2.8% at 3 years||||
71719677|NCT01963767|142954981|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||Ancovas were conducted with group as the between subjects factor and performance at baseline as the covariate.||||.03
71719678|NCT03941483|142954988|SUPERIORITY||Risk Ratio (RR)|1.174||||0.595|TWO_SIDED|90.0|0.715|1.927|||Chi-squared|||||1.927|0.715|0.595
71719679|NCT03941483|142954989|SUPERIORITY||Risk Ratio (RR)|1.297||||0.335|TWO_SIDED|90.0|0.831|2.026|||Chi-squared|||||2.026|0.831|0.335
71719680|NCT03941483|142954990|SUPERIORITY||Risk Ratio (RR)|1.025||||0.773|TWO_SIDED|90.0|0.891|1.179|||Chi-squared|||||1.179|0.891|0.773
71719681|NCT03941483|142954991|SUPERIORITY||Risk Ratio (RR)|1.038||||0.563|TWO_SIDED|90.0|0.935|1.152|||Chi-squared|||||1.152|0.935|0.563
71829538|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|10.0||0.9242|ONE_SIDED|95.0|-31.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-31.3|0.9242
71719682|NCT03941483|142954992|SUPERIORITY||Risk Ratio (RR)|1.174||||0.717|TWO_SIDED|90.0|0.567|2.429|||Chi-squared|||||2.429|0.567|0.717
71719683|NCT03941483|142954993|SUPERIORITY||Risk Ratio (RR)|1.614||||0.266|TWO_SIDED|90.0|0.789|3.3|||Chi-squared|||||3.300|0.789|0.266
71719684|NCT01082081|142954994|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.77||||0.0004|TWO_SIDED|95.0|2.15|7.39|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.||7.39|2.15|0.0004
71719685|NCT01082081|142954994|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.25|||<|0.0001|TWO_SIDED|95.0|4.04|10.45|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||10.45|4.04|<0.0001
71719686|NCT01082081|142954994|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.48||||0.1307|TWO_SIDED|95.0|-0.74|5.69|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 500 mg caplet and placebo caplet.||5.69|-0.74|0.1307
71719687|NCT00932035|142955009|SUPERIORITY|To achieve a power of 0.84, a sample size of 72 patients, evenly distributed is required. With 36 patients per group, a Fisher's exact test with a one-sided alpha of 0.05 will have a 84% power to detect the difference between the experimental group (axillary reverse mapping) of 5% or less and a control group (standard dissection) of 30% or more. Response estimates were chosen based on reported lymphedema rates.||||||0.45|||||||Fisher Exact|||||||0.45
71657069|NCT02944383|142831653|SUPERIORITY|||||||0.3201||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3201
71719688|NCT00932035|142955010|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.50
71719689|NCT00932035|142955011|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
71719690|NCT02709512|142955034|SUPERIORITY|Relative Risk Ratio (ADIPemPlatinum/PlaceboPemPlatinum) is the common relative risk of having a response (CR or PR) based on the Mantel-Haenszel estimator controlling for tumor histology. A relative risk ratio greater than one is favorable to ADIPemPlatinum.|Risk Ratio (RR)|1.02||||0.9489|TWO_SIDED|95.0|0.5|2.11|||Cochran-Mantel-Haenszel|||||2.11|0.50|0.9489
71719691|NCT02709512|142955035|SUPERIORITY||Cox Proportional Hazard|0.64||||0.0078|TWO_SIDED|95.0|0.47|0.88|||Log Rank|||||0.88|0.47|0.0078
71719692|NCT02709512|142955036|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0234|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||||0.93|0.55|0.0234
71719693|NCT02709512|142955037|SUPERIORITY||Cox Proportional Hazard|0.65||||0.0193|TWO_SIDED|95.0|0.46|0.9|||Log Rank|||||0.90|0.46|0.0193
71829539|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.8||0.9876|ONE_SIDED|95.0|-38.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-38.8|0.9876
71719694|NCT00600106|142955044|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.36|||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.36
71719695|NCT00600106|142955045|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.93
71719696|NCT00600106|142955046|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.77|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.77
71768817|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.1735|TWO_SIDED|90.0|0.11|1.24|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 1.||1.24|0.11|0.1735
71829540|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.1|STANDARD_ERROR_OF_MEAN|8.7||0.9802|ONE_SIDED|95.0|-32.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-32.5|0.9802
71829541|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|10.6||0.5705|ONE_SIDED|95.0|-19.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.5|0.5705
71829542|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|10.3||0.8063|ONE_SIDED|95.0|-26.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-26.1|0.8063
71829543|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|9.1||0.6667|ONE_SIDED|95.0|-19.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-19.1|0.6667
71829544|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|10.4||0.464|ONE_SIDED|95.0|-16.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-16.4|0.4640
71829545|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|10.2||0.8821|ONE_SIDED|95.0|-29.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-29.3|0.8821
71829546|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|9.0||0.7591|ONE_SIDED|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-21.4|0.7591
71829547|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|11.0||0.4001|ONE_SIDED|95.0|-15.6||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.6|0.4001
71887444|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|0.48|||>|0.05|TWO_SIDED|95.0|0.16|1.47||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -1.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||1.47|0.16|>0.05
71719697|NCT00600106|142955048|SUPERIORITY_OR_OTHER|All tests were two-sided with p values \<0.05.||||||0.38|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."||||0.38
71719698|NCT00600106|142955052|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated. All tests were two-sided with p values \<0.05."||||0.17
71719699|NCT00600106|142955053|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.49
71719700|NCT00600106|142955054|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.77
71719701|NCT00600106|142955055|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.40
71719702|NCT00600106|142955056|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.99
71829548|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|10.8||0.8707|ONE_SIDED|95.0|-30.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-30.3|0.8707
71829549|NCT00430300|143163124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|9.6||0.4629|ONE_SIDED|95.0|-15.0||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|||-15.0|0.4629
71829550|NCT00430300|143163125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6428|||||TWO_SIDED|95.0|0.2023|2.0419||||||A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0419|0.2023|
71719703|NCT00600106|142955057|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.21
71719704|NCT00252512|142955058|SUPERIORITY||||||<|0.001||||||Above is calculated p value, a priori threshold for significance set at \<.05|GEE full factorial modeling|||||||<.001
71719705|NCT00252512|142955059|SUPERIORITY|||||||0.015||||||a priori threshold of \<.05|t-test, 2 sided|||8 week analysis||||.015
71719706|NCT00252512|142955059|SUPERIORITY|||||||0.45||||||a priori threshold of \<.05|t-test, 2 sided|||6 month analysis||||0.45
71719707|NCT00252512|142955059|SUPERIORITY|||||||0.0497||||||a prior threshold of .05|t-test, 2 sided|||12 month analysis||||.0497
71719708|NCT00252512|142955060|SUPERIORITY||||||>|0.05||||||a priori threshold \<.05|Estimation Equation mean modeling|||Costs for period between 6 month follow-up and 12 month follow up.||||>.05
71719709|NCT00252512|142955060|SUPERIORITY||||||>|0.05|||||||Estimating Equation mean modeling|||Costs for period between 6 month follow up and 12 month follow up.||||>.05
71719710|NCT00252512|142955061|SUPERIORITY|||||||0.28||||||a priori threshold \<.05|Chi-squared|||Analysis for 8 week follow up||||.28
71719711|NCT00252512|142955061|SUPERIORITY|||||||0.013||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up||||.013
71719712|NCT00252512|142955061|SUPERIORITY|||||||0.76||||||A priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up||||.76
71719713|NCT00252512|142955062|SUPERIORITY|||||||0.66||||||A priori threshold \<.05|Chi-squared|||Analysis for 8 week follow-up||||.66
71719714|NCT00252512|142955062|SUPERIORITY|||||||0.37||||||A priori threshold \<.05|Chi-squared|||Analysis for 6 month follow up.||||.37
71719715|NCT00252512|142955062|SUPERIORITY|||||||0.19||||||a priori threshold \<.05|Chi-squared|||Analysis for 12 month follow up.||||.19
71719716|NCT00252512|142955063|SUPERIORITY|||||||0.05||||||A priori threshold of \<.05|Chi-squared|||Analysis for 8 week follow-up||||.05
71719717|NCT00252512|142955063|SUPERIORITY|||||||0.8||||||A priori threshold of \<.05|Chi-squared|||Analysis for 6 month follow-up.||||.80
71719718|NCT00252512|142955063|SUPERIORITY|||||||0.12||||||A priori threshold of \<.05|Chi-squared|||Analysis for 12 month follow-up.||||.12
71719719|NCT00460655|142955076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.428||||0.006||95.0|-5.841|-1.016|||t-test, 2 sided|||||-1.016|-5.841|0.006
71719720|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.049||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.||||0.0490
71719721|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.19||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
71719722|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.0017||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0017
71719723|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.0092||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0092
71829551|NCT00430300|143163125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5574|||||TWO_SIDED|95.0|0.1505|2.0647||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.0647|0.1505|
71829552|NCT00430300|143163125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327|||||TWO_SIDED|95.0|0.083|1.2879||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.2879|0.0830|
71829553|NCT00430300|143163126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5709|||||TWO_SIDED|95.0|0.179|1.8204||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||1.8204|0.1790|
71719724|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.45||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.45
71719725|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.18
71719726|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.47||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.47
71719727|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.0423||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0423
71719728|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.15||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.15
71719729|NCT01665911|142955092|SUPERIORITY_OR_OTHER|||||||0.54||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.54
71719730|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.24||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.24
71719731|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.17||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.17
71719732|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.0008||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0008
71719733|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.0003||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0003
71719734|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.24||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.24
71719735|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.26||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.26
71719736|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.18
71719737|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.0269||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0269
71719738|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.0142||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0142
71719739|NCT01665911|142955093|SUPERIORITY_OR_OTHER|||||||0.81||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.81
71719740|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||||||0.0000
71719741|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
71719742|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
71719743|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0000
71719744|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0.14||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA|||||||0.14
71719745|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0.0012||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0012
71719746|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0.19||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.19
71719747|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA|||||||0.0000
71719748|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0.0075||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0075
71768818|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.2305|TWO_SIDED|90.0|0.78|4.75|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 2.||4.75|0.78|0.2305
71768819|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.2507|TWO_SIDED|90.0|0.77|4.5|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 2.||4.50|0.77|0.2507
71768820|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.5608|TWO_SIDED|90.0|0.35|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 3.||1.64|0.35|0.5608
71768821|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.6526|TWO_SIDED|90.0|0.6|2.42|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 3.||2.42|0.60|0.6526
71768822|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.0208|TWO_SIDED|90.0|0.21|0.77|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 4.||0.77|0.21|0.0208
71768823|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2859|TWO_SIDED|90.0|0.39|1.22|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 4.||1.22|0.39|0.2859
71768824|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.7921|TWO_SIDED|90.0|0.49|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 5.||1.66|0.49|0.7921
71768825|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.362|TWO_SIDED|90.0|0.79|2.31|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 5.||2.31|0.79|0.3620
71719749|NCT01665911|142955094|SUPERIORITY_OR_OTHER|||||||0.0444||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA|||||||0.0444
71719750|NCT01484496|142955114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0006|TWO_SIDED|95.0|1.25|2.25|||Regression, Logistic|||||2.25|1.25|0.0006
71719751|NCT01484496|142955115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.0004|TWO_SIDED|95.0|0.35|0.74|||Cox proportional hazards model|||||0.74|0.35|0.0004
71719752|NCT01484496|142955116|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0732|TWO_SIDED|95.0|0.95|2.84|||Regression, Logistic|||||2.84|0.95|0.0732
71719753|NCT01816776|142955142|SUPERIORITY||Risk Difference (RD)|41.0|||<|0.0001|TWO_SIDED|95.0|25.0|54.0||1-sided. p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||54|25|<0.0001
71719754|NCT01816776|142955144|SUPERIORITY||Mean Difference (Net)|-22.8|||<|0.0001|TWO_SIDED|95.0|-29.0|-16.6||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-16.6|-29.0|<0.0001
71719755|NCT01816776|142955145|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.0001|TWO_SIDED|95.0|-31.2|-18.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-18.7|-31.2|<0.0001
71719756|NCT01816776|142955146|SUPERIORITY||Mean Difference (Net)|-15.2|||<|0.0001|TWO_SIDED|95.0|-21.6|-8.7||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-8.7|-21.6|<0.0001
71719757|NCT01816776|142955147|SUPERIORITY||Mean Difference (Net)|2.4||||0.0244|TWO_SIDED|95.0|-0.4|5.1||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||5.1|-0.4|0.0244
71719758|NCT01816776|142955148|SUPERIORITY||Risk Difference (RD)|55.0|||<|0.0001|TWO_SIDED|95.0|40.0|68.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Fisher Exact||Risk difference = Treatment - Control|||68|40|<0.0001
71768826|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.4331|TWO_SIDED|90.0|0.44|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 6.||1.34|0.44|0.4331
71768827|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.0047|TWO_SIDED|90.0|1.42|3.75|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 6.||3.75|1.42|0.0047
71768828|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4431|TWO_SIDED|90.0|0.46|1.32|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 8.||1.32|0.46|0.4431
71768829|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1901|TWO_SIDED|90.0|0.9|2.44|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 8.||2.44|0.90|0.1901
71768830|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.9222|TWO_SIDED|90.0|0.56|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 10.||1.66|0.56|0.9222
71768831|NCT00420641|143038025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.1665|TWO_SIDED|90.0|0.93|2.43|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 10.||2.43|0.93|0.1665
71768832|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.5057|TWO_SIDED|90.0|0.2|1.98|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 1.||1.98|0.20|0.5057
71768833|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8633|TWO_SIDED|90.0|0.38|3.3|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 1.||3.30|0.38|0.8633
71768834|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.8428|TWO_SIDED|90.0|0.55|2.16|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 2.||2.16|0.55|0.8428
71887445|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|1.12|||<|0.001|TWO_SIDED|95.0|0.6|2.08||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.10|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||2.08|0.60|<0.001
71719759|NCT01816776|142955149|SUPERIORITY||Mean Difference (Net)|-22.7|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.5||Secondary endpoints hierarchically tested with p\<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment - Control|||-16.5|-28.9|<0.0001
71719760|NCT01816776|142955150|SUPERIORITY||Mean Difference (Net)|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.5|-2.0||1-sided. Secondary endpoints hierarchically tested with p\<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment - Control|||-2.0|-5.5|<0.0001
71719761|NCT00770562|142955151|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
71719762|NCT00770562|142955152|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
71719763|NCT00770562|142955153|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher Exact|||||||0.015
71719764|NCT01057693|142955162|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32||||0.1221|TWO_SIDED|95.0|-0.74|0.09|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.||0.09|-0.74|0.1221
71719765|NCT00237666|142955189|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71719766|NCT00363142|142955213|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of FPV/r100 to FPV/r200 would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in percentage of participants not meeting the virologic failure definition \[FPV/r100 minus FPV/r200\] was -12% or greater.|Difference in the percentages|-2.12||||||95.0|-9.36|5.12|||||Difference in percentages = percentage in Arm 1 minus percentage in Arm 2|||5.12|-9.36|
71719767|NCT01313910|142955236|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxin-rank test used to determine decrease in bowel movements/day after 8 weeks of intervention||||0.008
71768835|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.3416|TWO_SIDED|90.0|0.76|2.84|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 2.||2.84|0.76|0.3416
71768836|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.3287|TWO_SIDED|90.0|0.4|1.26|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 3.||1.26|0.40|0.3287
71719768|NCT01313910|142955237|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71719769|NCT01313910|142955238|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71719770|NCT01313910|142955240|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71719771|NCT01340664|142955251|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.637|-0.251|||ANCOVA|||||-0.251|-0.637|<0.001
71719772|NCT01340664|142955251|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.792|-0.407|||ANCOVA|||||-0.407|-0.792|<0.001
71719773|NCT01340664|142955252|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-23.6|STANDARD_ERROR_OF_MEAN|4.673|<|0.001|TWO_SIDED|95.0|-32.78|-14.38|||ANCOVA|||||-14.38|-32.78|<0.001
71768837|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.2112|TWO_SIDED|90.0|0.88|2.57|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 3.||2.57|0.88|0.2112
71768838|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.0134|TWO_SIDED|90.0|0.26|0.76|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 4.||0.76|0.26|0.0134
71719774|NCT01340664|142955252|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-24.0|STANDARD_ERROR_OF_MEAN|4.661|<|0.001||95.0|-33.18|-14.83|||ANCOVA|||||-14.83|-33.18|<0.001
71719775|NCT01340664|142955253|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.1|-1.3|||ANCOVA|||||-1.3|-3.1|<0.001
71719776|NCT01340664|142955253|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.5|-1.7|||ANCOVA|||||-1.7|-3.5|<0.001
71719777|NCT01340664|142955254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.013|TWO_SIDED|95.0|1.21|4.9|||Regression, Logistic|||||4.90|1.21|0.013
71719778|NCT01340664|142955254|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.38|||<|0.001|TWO_SIDED|95.0|1.68|6.81|||Regression, Logistic|||||6.81|1.68|<0.001
71719779|NCT01926444|142955265|OTHER|||||||0.506|||||||ANOVA|||AUC- censorsed (standardized); FAS||||0.506
71768839|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.3412|TWO_SIDED|90.0|0.81|2.17|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 4.||2.17|0.81|0.3412
71719780|NCT01926444|142955265|OTHER|||||||0.299|||||||ANOVA|||AUC LOCF (standardized); FAS||||0.299
71719781|NCT01926444|142955265|OTHER|||||||0.234|||||||ANOVA|||AUC Censored (Standardized)- PP Population||||0.234
71719782|NCT01926444|142955265|OTHER|||||||0.219|||||||ANOVA|||AUC LOCF (Standardized)- PP Population||||0.219
71719783|NCT01926444|142955266|OTHER|||||||0.047|||||||Chi-squared|||Time to Caecum||||0.047
71719784|NCT01926444|142955267|OTHER|||||||0.047|||||||Chi-squared|||||||0.047
71719785|NCT01637584|142955310|SUPERIORITY_OR_OTHER||||||<|0.001||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38||||<0.001
71719786|NCT01637584|142955310|SUPERIORITY_OR_OTHER|||||||0.039||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;||||0.039
71719787|NCT01637584|142955310|SUPERIORITY_OR_OTHER|||||||0.701||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \> (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report||||0.701
71768840|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8434|TWO_SIDED|90.0|0.58|1.54|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 5.||1.54|0.58|0.8434
71768841|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0819|TWO_SIDED|90.0|1.03|2.63|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 5.||2.63|1.03|0.0819
71768842|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.2832|TWO_SIDED|90.0|0.44|1.19|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 6.||1.19|0.44|0.2832
71768843|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0016|TWO_SIDED|90.0|1.54|3.97|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 6.||3.97|1.54|0.0016
71768844|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9727|TWO_SIDED|90.0|0.6|1.63|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 8.||1.63|0.60|0.9727
71768845|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|90.0|1.6|4.13|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 8.||4.13|1.60|0.0010
71768846|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8312|TWO_SIDED|90.0|0.64|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 10.||1.80|0.64|0.8312
71768847|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06||||0.0002|TWO_SIDED|90.0|1.86|5.02|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 10.||5.02|1.86|0.0002
71768848|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.553|TWO_SIDED|90.0|0.13|2.6|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 1.||2.60|0.13|0.5530
71768849|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.978|TWO_SIDED|90.0|0.28|3.41|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 1.||3.41|0.28|0.9780
71768850|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8312|TWO_SIDED|90.0|0.43|3.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 2.||3.03|0.43|0.8312
71768851|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.1881|TWO_SIDED|90.0|0.83|5.25|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 2.||5.25|0.83|0.1881
71768852|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.6384|TWO_SIDED|90.0|0.39|1.69|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 3.||1.69|0.39|0.6384
71768853|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.216|TWO_SIDED|90.0|0.84|3.37|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 3.||3.37|0.84|0.2160
71768854|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0259|TWO_SIDED|90.0|0.2|0.79|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 4.||0.79|0.20|0.0259
71768855|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.3959|TWO_SIDED|90.0|0.39|1.35|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 4.||1.35|0.39|0.3959
71768856|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.3857|TWO_SIDED|90.0|0.39|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 5.||1.34|0.39|0.3857
71768857|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.3126|TWO_SIDED|90.0|0.8|2.52|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 5.||2.52|0.80|0.3126
71768858|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.1182|TWO_SIDED|90.0|0.36|1.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 6.||1.03|0.36|0.1182
71768859|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.0125|TWO_SIDED|90.0|1.29|3.43|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 6.||3.43|1.29|0.0125
71768860|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.2147|TWO_SIDED|90.0|0.42|1.13|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 8.||1.13|0.42|0.2147
71768861|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.0783|TWO_SIDED|90.0|1.03|2.69|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 8.||2.69|1.03|0.0783
71768862|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9067||90.0|0.57|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 10.||1.64|0.57|0.9067
71768863|NCT00420641|143038026|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0328|TWO_SIDED|90.0|1.15|2.92|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 10.||2.92|1.15|0.0328
71768864|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6928|TWO_SIDED|90.0|0.44|3.76|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.||3.76|0.44|0.6928
71768865|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.3039|TWO_SIDED|90.0|0.69|5.01|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.||5.01|0.69|0.3039
71768866|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.1938|TWO_SIDED|90.0|0.89|2.7|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.||2.70|0.89|0.1938
71768867|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.06|TWO_SIDED|90.0|1.08|3.16|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.||3.16|1.08|0.0600
71657070|NCT02944383|142831653|SUPERIORITY|||||||0.901||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9010
71768868|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8989|TWO_SIDED|90.0|0.61|1.53|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.||1.53|0.61|0.8989
71768869|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.0136|TWO_SIDED|90.0|1.25|3.05|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.||3.05|1.25|0.0136
71768870|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3099|TWO_SIDED|90.0|0.5|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.||1.18|0.50|0.3099
71719788|NCT01637584|142955310|SUPERIORITY_OR_OTHER|||||||1||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness \< REM: No cluster size, coordinates, or brain regions to report||||1.00
71719789|NCT01637584|142955310|SUPERIORITY_OR_OTHER|||||||0.03||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;||||0.03
71719790|NCT01637584|142955310|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: \<.05|Full Factorial ANOVAs and Paired T-tests|||Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42||||0.01
71719791|NCT02969915|142955326|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.64|2.26||||||||2.26|0.64|
71719792|NCT02969915|142955327|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.91|1.9||||||||1.90|0.91|
71719793|NCT02969915|142955328|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.7|1.95||||||||1.95|0.70|
71719794|NCT02969915|142955329|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95||||||||1.95|0.85|
71768871|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1137|TWO_SIDED|90.0|0.98|2.27|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.||2.27|0.98|0.1137
71887446|NCT01337973|143295796|SUPERIORITY||Coefficient Estimate|1.09|||<|0.01|TWO_SIDED|95.0|0.4|2.95||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.17|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline||2.95|0.40|<0.01
71719795|NCT02969915|142955330|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|0.79|1.75||||||||1.75|0.79|
71719796|NCT02969915|142955331|SUPERIORITY||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.38|5.76||||||||5.76|0.38|
71719797|NCT02969915|142955332|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.68|1.36||||||||1.36|0.68|
71719798|NCT02969915|142955333|SUPERIORITY||Risk Ratio, log|1.38|||||TWO_SIDED|95.0|0.77|2.46||||||||2.46|0.77|
71719799|NCT02969915|142955334|SUPERIORITY||Risk Ratio (RR)|0.39|||||TWO_SIDED|95.0|0.09|1.8||||||||1.80|0.09|
71719800|NCT01393899|142955361|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||||14.99|-12.11|
71719801|NCT01393899|142955361|SUPERIORITY_OR_OTHER||Difference in Percentage|17.72|||||TWO_SIDED|80.0|4.07|31.37||||||||31.37|4.07|
71719802|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|0.61|||||TWO_SIDED|80.0|-11.57|12.79||||||Week 4||12.79|-11.57|
71719803|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|0.78|||||TWO_SIDED|80.0|-12.29|13.84||||||Week 8||13.84|-12.29|
71719804|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
71719805|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.94|||||TWO_SIDED|80.0|-14.56|12.68||||||Week 20||12.68|-14.56|
71719806|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|5.26|||||TWO_SIDED|80.0|-6.52|17.04||||||Week 4||17.04|-6.52|
71719807|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
71719808|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|3.49|||||TWO_SIDED|80.0|-10.4|17.37||||||Week 12||17.37|-10.40|
71719809|NCT01393899|142955362|SUPERIORITY_OR_OTHER||Difference in Percentage|10.69|||||TWO_SIDED|80.0|-3.08|24.46||||||Week 20||24.46|-3.08|
71719810|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.72|||||TWO_SIDED|80.0|-14.06|10.63||||||Week 4||10.63|-14.06|
71719811|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|-3.88|||||TWO_SIDED|80.0|-17.15|9.4||||||Week 8||9.40|-17.15|
71719812|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|5.81|||||TWO_SIDED|80.0|-8.04|19.67||||||Week 12||19.67|-8.04|
71719813|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|1.44|||||TWO_SIDED|80.0|-12.11|14.99||||||Week 20||14.99|-12.11|
71719814|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|1.5|||||TWO_SIDED|80.0|-11.88|14.87||||||Week 26||14.87|-11.88|
71719815|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|2.93|||||TWO_SIDED|80.0|-9.06|14.92||||||Week 4||14.92|-9.06|
71719816|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.53|||||TWO_SIDED|80.0|-21.94|4.88||||||Week 8||4.88|-21.94|
71719817|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|1.16|||||TWO_SIDED|80.0|-12.74|15.06||||||Week 12||15.06|-12.74|
71719818|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|13.07|||||TWO_SIDED|80.0|-0.63|26.77||||||Week 20||26.77|-0.63|
71719819|NCT01393899|142955363|SUPERIORITY_OR_OTHER||Difference in Percentage|20.1|||||TWO_SIDED|80.0|6.54|33.66||||||Week 26||33.66|6.54|
71719820|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|3.43|||||TWO_SIDED|80.0|-10.41|17.28||||||Week 4||17.28|-10.41|
71719821|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|1.22|||||TWO_SIDED|80.0|-12.67|15.11||||||Week 8||15.11|-12.67|
71719822|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|13.18|||||TWO_SIDED|80.0|-0.31|26.67||||||Week 12||26.67|-0.31|
71719823|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-11.33|14.55||||||Week 20||14.55|-11.33|
71719824|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|8.64|||||TWO_SIDED|80.0|-4.36|21.64||||||Week 26||21.64|-4.36|
71719825|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|5.76|||||TWO_SIDED|80.0|-8.04|19.56||||||Week 4||19.56|-8.04|
71719826|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.08|||||TWO_SIDED|80.0|-21.83|5.66||||||Week 8||5.66|-21.83|
71719827|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|1.55|||||TWO_SIDED|80.0|-11.63|14.73||||||Week 12||14.73|-11.63|
71768872|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8682||90.0|0.67|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.||1.64|0.67|0.8682
71829554|NCT00430300|143163126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6416|||||TWO_SIDED|95.0|0.1736|2.3715||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.3715|0.1736|
71829555|NCT00430300|143163126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5877|||||TWO_SIDED|95.0|0.1516|2.2777||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.||2.2777|0.1516|
71719828|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|8.58|||||TWO_SIDED|80.0|-4.64|21.81||||||Week 20||21.81|-4.64|
71719829|NCT01393899|142955364|SUPERIORITY_OR_OTHER||Difference in Percentage|13.29|||||TWO_SIDED|80.0|0.15|26.43||||||Week 26||26.43|0.15|
71719830|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|6.57|||||TWO_SIDED|80.0|-8.63|21.78||||||Week 4||21.78|-8.63|
71719831|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|0.29|||||TWO_SIDED|80.0|-16.63|17.2||||||Week 8||17.20|-16.63|
71768873|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.0006|TWO_SIDED|90.0|1.63|4.03|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.||4.03|1.63|0.0006
71768874|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8992|TWO_SIDED|90.0|0.62|1.51|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.||1.51|0.62|0.8992
71829556|NCT02666742|143163134|SUPERIORITY|Continuous variables were compared by two-sample t-tests and categorical variables by chi-square test. All tests were two-tailed, and a P value less than 0.05 was considered to indicate statistical significance. Bonferroni correction was not performed due to prespecified outcomes in the trial. Analyses were performed using GraphPad 6||||||0.001|||||||Chi-squared|||Due to lack of precedent robust clinical data, we performed exploratory study to evaluate safety and efficacy of DOAC vs. Aspirin (ASA) in patients undergoing left ventricular arrhythmia (LVA) ablation; therefore, sample size calculation was not undertaken.||||0.001
71829557|NCT01063517|143163149|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|80.0|0.62|1.03|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||1.03|0.62|
71719832|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|24.29|||||TWO_SIDED|80.0|7.19|41.38||||||Week 12||41.38|7.19|
71719833|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|6.86|||||TWO_SIDED|80.0|-10.32|24.03||||||Week 20||24.03|-10.32|
71719834|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|11.29|||||TWO_SIDED|80.0|-5.22|27.79||||||Week 26||27.79|-5.22|
71719835|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|8.77|||||TWO_SIDED|80.0|-6.41|23.95||||||Week 4||23.95|-6.41|
71719836|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.0|||||TWO_SIDED|80.0|-31.59|3.59||||||Week 8||3.59|-31.59|
71719837|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|2.31|||||TWO_SIDED|80.0|-15.35|19.97||||||Week 12||19.97|-15.35|
71719838|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|10.15|||||TWO_SIDED|80.0|-7.41|27.71||||||Week 20||27.71|-7.41|
71719839|NCT01393899|142955365|SUPERIORITY_OR_OTHER||Difference in Percentage|22.0|||||TWO_SIDED|80.0|4.96|39.04||||||Week 26||39.04|4.96|
71719840|NCT01393899|142955366|SUPERIORITY_OR_OTHER||Difference in Percentage|1.83|||||TWO_SIDED|80.0|-9.75|13.4||||||||13.40|-9.75|
71719841|NCT01393899|142955366|SUPERIORITY_OR_OTHER||Difference in Percentage|18.11|||||TWO_SIDED|80.0|5.57|30.64||||||||30.64|5.57|
71719842|NCT01393899|142955367|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.75|||||TWO_SIDED|80.0|-20.39|4.88||||||||4.88|-20.39|
71719843|NCT01393899|142955367|SUPERIORITY_OR_OTHER||Difference in Percentage|17.83|||||TWO_SIDED|80.0|4.33|31.33||||||||31.33|4.33|
71719844|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.26|||=|0.0637|TWO_SIDED|80.0|-51.1|-9.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-9.42|-51.10|=0.0637
71719845|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.06|||=|0.3054|TWO_SIDED|80.0|-47.43|5.31|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||5.31|-47.43|=0.3054
71719846|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.52|||=|0.1316|TWO_SIDED|80.0|-78.57|-6.48|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-6.48|-78.57|=0.1316
71719847|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Dofference|-18.01|||=|0.5704|TWO_SIDED|80.0|-59.01|22.99|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||22.99|-59.01|=0.5704
71719848|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.0|||=|0.8389|TWO_SIDED|80.0|-44.22|32.21|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||32.21|-44.22|=0.8389
71719849|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.56|||=|0.1452|TWO_SIDED|80.0|-44.27|-2.85|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-2.85|-44.27|=0.1452
71719850|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.61|||=|0.6399|TWO_SIDED|80.0|-36.03|16.81|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||16.81|-36.03|=0.6399
71768875|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.0004|TWO_SIDED|90.0|1.67|4.09|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.||4.09|1.67|0.0004
71768876|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.28|TWO_SIDED|90.0|0.85|2.23|||Placebo versus GSK372475 in percentage o|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.||2.23|0.85|0.2800
71768877|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69||||0|TWO_SIDED|90.0|2.24|6.08|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.||6.08|2.24|0.0000
71719851|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.0|||=|0.1949|TWO_SIDED|80.0|-73.57|-0.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.42|-73.57|=0.1949
71719852|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.74|||=|0.1358|TWO_SIDED|80.0|-88.62|-6.87|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-6.87|-88.62|=0.1358
71719853|NCT01393899|142955369|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.38|||=|0.089|TWO_SIDED|80.0|-88.03|-12.72|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-12.72|-88.03|=0.0890
71719854|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.44|||||TWO_SIDED|80.0|-16.14|1.26||||||Week 4||1.26|-16.14|
71719855|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.43|||||TWO_SIDED|80.0|-18.27|3.41||||||Week 8||3.41|-18.27|
71719856|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.48|||||TWO_SIDED|80.0|-25.68|0.72||||||Week 12||0.72|-25.68|
71768878|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.0507|TWO_SIDED|90.0|1.1|3.13|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.||3.13|1.10|0.0507
71829558|NCT01063517|143163150|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|80.0|0.51|1.08|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||1.08|0.51|
71829559|NCT01063517|143163151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|80.0|0.41|0.75|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).||0.75|0.41|
71829560|NCT01063517|143163152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|80.0|0.22|0.56|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).||0.56|0.22|
71719857|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.73|||||TWO_SIDED|80.0|-26.81|1.34||||||Week 20||1.34|-26.81|
71719858|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-18.9|||||TWO_SIDED|80.0|-39.52|1.72||||||Week 26||1.72|-39.52|
71719859|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.96|||||TWO_SIDED|80.0|-12.39|6.48||||||Week 4||6.48|-12.39|
71719860|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|1.61|||||TWO_SIDED|80.0|-10.14|13.36||||||Week 8||13.36|-10.14|
71719861|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-8.09|||||TWO_SIDED|80.0|-21.54|5.36||||||Week 12||5.36|-21.54|
71719862|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.9|||||TWO_SIDED|80.0|-26.99|1.19||||||Week 20||1.19|-26.99|
71719863|NCT01393899|142955370|SUPERIORITY_OR_OTHER||Difference in Percentage|-26.28|||||TWO_SIDED|80.0|-46.54|-6.02||||||Week 26||-6.02|-46.54|
71719864|NCT01393899|142955371|SUPERIORITY_OR_OTHER||Difference in Percentage|10.61|||||TWO_SIDED|80.0|-11.44|32.66||||||||32.66|-11.44|
71719865|NCT01393899|142955371|SUPERIORITY_OR_OTHER||Difference in Percentage|16.67|||||TWO_SIDED|80.0|-4.15|37.49||||||||37.49|-4.15|
71719866|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.53|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.53|-1.34|<0.0001
71719867|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.76|||=|0.0024|TWO_SIDED|95.0|-1.24|-0.28|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.28|-1.24|=0.0024
71719868|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||=|0.0044|TWO_SIDED|95.0|-1.26|-0.24|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.24|-1.26|=0.0044
71719869|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0582|TWO_SIDED|95.0|-1.13|0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||0.02|-1.13|=0.0582
71719870|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.61|||=|0.0865|TWO_SIDED|95.0|-1.31|0.09|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||0.09|-1.31|=0.0865
71719871|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.52|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4||-0.52|-1.32|<0.0001
71719872|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.92|||=|0.0002|TWO_SIDED|95.0|-1.4|-0.45|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.45|-1.40|=0.0002
71719873|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.75|-0.71|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.71|-1.75|<0.0001
71719874|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.74|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20||-0.74|-1.87|<0.0001
71719875|NCT01393899|142955373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.95|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.95|-2.30|<0.0001
71719876|NCT01393899|142955375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.39|||=|0.0566|TWO_SIDED|95.0|-0.79|0.01|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||0.01|-0.79|=0.0566
71719877|NCT01393899|142955375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21|||=|0.3144|TWO_SIDED|95.0|-0.61|0.2|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||0.20|-0.61|=0.3144
71719878|NCT01393899|142955375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||=|0.0434|TWO_SIDED|95.0|-1.1|-0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.02|-1.10|=0.0434
71768879|NCT00420641|143038027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.97||||0.0003|TWO_SIDED|90.0|1.81|4.88|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.||4.88|1.81|0.0003
71829561|NCT00546871|143163209|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.067|||||ONE_SIDED|99.0||0.134||||||||0.134||
71829562|NCT01350804|143163230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0458|TWO_SIDED|95.0|1.0|3.2|||Regression, Logistic|||||3.2|1.0|0.0458
71719879|NCT01393899|142955375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.57|||=|0.005|TWO_SIDED|95.0|-0.96|-0.18|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8||-0.18|-0.96|=0.0050
71719880|NCT01393899|142955375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.66|||=|0.0017|TWO_SIDED|95.0|-1.06|-0.25|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12||-0.25|-1.06|=0.0017
71719881|NCT01393899|142955375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.72|-0.67|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26||-0.67|-1.72|<0.0001
71719882|NCT02520388|142955397|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
71719883|NCT02520388|142955398|SUPERIORITY|||||||0.05|||||||Mixed model repeated measures analysis|||||||0.05
71719884|NCT03035864|142955412|SUPERIORITY||difference in LS means|-0.11|||=|0.974|TWO_SIDED|95.0|-6.85|6.63|||ANCOVA|||Frequency statistical analysis||6.63|-6.85|=0.974
71719885|NCT03035864|142955412|SUPERIORITY||Difference in least square means|2.88|||=|0.399|TWO_SIDED|95.0|-3.85|9.61|||ANCOVA|||Statistical analysis related to severity||9.61|-3.85|=0.399
71719886|NCT03035864|142955413|SUPERIORITY||difference in least square means|0.04|||=|0.214|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.10|-0.02|=0.214
71719887|NCT03035864|142955417|SUPERIORITY||difference in least square means|-0.43|||=|0.881|TWO_SIDED|95.0|-6.13|5.27|||ANCOVA|||Frequency - week 4||5.27|-6.13|=0.881
71719888|NCT03035864|142955417|SUPERIORITY||difference in least square means|-0.31|||=|0.926|TWO_SIDED|95.0|-6.96|6.33|||ANCOVA|||Frequency - week 8||6.33|-6.96|=0.926
71719889|NCT03035864|142955417|SUPERIORITY||difference in least square means|-2.29|||=|0.426|TWO_SIDED|95.0|-7.97|3.38|||ANCOVA|||Frequency - Week 12||3.38|-7.97|=0.426
71719890|NCT03035864|142955417|SUPERIORITY||Difference in least square means|0.62|||=|0.828|TWO_SIDED|95.0|-5.04|6.29|||ANCOVA|||Severity - Week 4||6.29|-5.04|=0.828
71719891|NCT03035864|142955417|SUPERIORITY||difference in least square means|2.86|||=|0.394|TWO_SIDED|95.0|-3.75|9.47|||ANCOVA|||Severity - Week 8||9.47|-3.75|=0.394
71719892|NCT03035864|142955417|SUPERIORITY||difference in least square means|-1.49|||=|0.552|TWO_SIDED|95.0|-6.41|3.44|||ANCOVA|||Severeity - Week 12||3.44|-6.41|=0.552
71719893|NCT01890265|142955419|SUPERIORITY||LS mean difference|4.33|||=|0.0331|TWO_SIDED|95.0|0.35|8.3||The analysis of the change from Baseline to Week 48 in FVC (% predicted) was based on the random coefficient regression model based on observed cases.|Random coefficient regression|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in FVC (% predicted) is presented.||8.3|0.35|= 0.0331
71719894|NCT01890265|142955420|SUPERIORITY||LS mean difference|-1.8|||=|0.0236|TWO_SIDED|95.0|-3.3|-0.2|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 24 in QLF score is presented.||-0.2|-3.3|= 0.0236
71719895|NCT01890265|142955420|SUPERIORITY||LS mean difference|-3.2|||=|0.0729|TWO_SIDED|95.0|-6.6|0.3|||ANCOVA with MI|||The absolute LS mean treatment difference (pamrevlumab - placebo) for change from Baseline to Week 48 in QLF score is presented.||0.3|-6.6|= 0.0729
71829563|NCT01350804|143163230|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.0152|TWO_SIDED|95.0|1.1|3.5|||Regression, Logistic|||||3.5|1.1|0.0152
71719896|NCT01890265|142955421|SUPERIORITY||Absolute difference|-21.4|||=|0.0133|TWO_SIDED|95.0|-36.6|-6.2|||Regression, Logistic|||The absolute treatment difference (pamrevlumab - placebo) for percentage of participants with IPF progression at Week 48 is presented.||-6.2|-36.6|= 0.0133
71719897|NCT00809926|142955426|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6||||0.295|TWO_SIDED|95.0|-4.61|1.4|||ANCOVA|||||1.40|-4.61|0.295
71719898|NCT00809926|142955427|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.79|TWO_SIDED|95.0|-1.93|1.47|||ANCOVA|||||1.47|-1.93|0.790
71719899|NCT00809926|142955428|SUPERIORITY_OR_OTHER||Difference|8.1||||0.101|TWO_SIDED|95.0|-1.56|17.67|||Cochran-Mantel-Haenszel|||||17.67|-1.56|0.101
71719900|NCT00809926|142955429|SUPERIORITY_OR_OTHER||Difference|11.6||||0.018|TWO_SIDED|95.0|2.0|21.33|||Cochran-Mantel-Haenszel|||||21.33|2.00|0.018
71719901|NCT00809926|142955432|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.4||||0.028|TWO_SIDED|95.0|-6.34|-0.37|||ANCOVA|||||-0.37|-6.34|0.028
71719902|NCT00809926|142955433|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.04|TWO_SIDED|95.0|-6.02|-0.14|||GENMOD|Based on a generalized estimating equations using SAS procedure GENMOD.||||-0.14|-6.02|0.040
71719903|NCT00809926|142955434|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-8.7||||0.004|TWO_SIDED|95.0|-14.38|-2.93|||ANCOVA|||||-2.93|-14.38|0.004
71719904|NCT00809926|142955435|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.9||||0.006|TWO_SIDED|95.0|-8.37|-1.42|||ANCOVA|||||-1.42|-8.37|0.006
71829564|NCT01359371|143163255|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||Bivariate relationships between a patient's participation in the program and smoking status were calculated.||||<.01
71829565|NCT01359371|143163256|OTHER|T-tests, chi squares and Fishers exact tests were used to compare groups.|||||<|0.05||||||This was just a sample description, so there was not adjustment for multiple comparisons.|Chi-squared||||T-tests, chi squares and Fishers exact tests were used to compare groups.|||<.05
71829566|NCT01359371|143163256|OTHER||||||<|0.05|||||||Chi-squared|||T-tests, chi squares and Fishers exact tests were used to compare groups.||||<.05
71829567|NCT04411082|143163275|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71829568|NCT04411082|143163276|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71829569|NCT04411082|143163277|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71829570|NCT04411082|143163278|SUPERIORITY||||||>|0.4839|||||||Fisher Exact|||||||>0.4839
71829571|NCT04411082|143163279|SUPERIORITY|||||||0.2065|||||||Fisher Exact|||||||0.2065
71829572|NCT04411082|143163280|SUPERIORITY|||||||0.4839|||||||Fisher Exact|||||||0.4839
71829573|NCT04411082|143163281|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71829574|NCT04411082|143163282|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71829575|NCT03762668|143163287|NON_INFERIORITY|Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.005|||ONE_SIDED|95.0||0.01|||mixed effects repeated measures model||test minus control|||0.01||
71719905|NCT01198574|142955471|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GLM for repeated measures|The Hb concentration at Week 0, Week 6 and Week 12 are analyzed using GLM repeated measures.||"Null Hypothesis~1. Haemoglobin level was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the haemoglobin level of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
71719906|NCT01198574|142955472|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null hypothesis~1. Iron status indicator (serum ferritin) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve the iron status indicator (serum ferritin) concentration of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
71719907|NCT01198574|142955473|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||GLM for repeated measures ANOVA|||"Null Hypothesis~1. iron status indicator (sTfR) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~2. Vitamin A does not improve iron status indicator (sTfR) of the anaemic schoolgirls during iron supplementation in the presence of inflammation."||||<0.05
71719908|NCT00325130|142955474|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719909|NCT00325130|142955476|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719910|NCT00325130|142955477|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719911|NCT00325130|142955478|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719912|NCT00325130|142955479|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71829576|NCT02027558|143163288|SUPERIORITY||Mean Difference (Net)|-3.21|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.58|-1.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-1.83|-4.58|<.001
71829577|NCT02027558|143163289|SUPERIORITY||Mean Difference (Net)|-16.23|STANDARD_ERROR_OF_MEAN|6.52||0.013|TWO_SIDED|95.0|-29.02|-2.49|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-2.49|-29.02|0.013
71719913|NCT00325130|142955480|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719914|NCT00325130|142955481|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719915|NCT00325130|142955482|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719916|NCT00325130|142955483|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719917|NCT00325130|142955484|NON_INFERIORITY_OR_EQUIVALENCE|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen \& Nurminen method for difference in proportions, Stat Med 1985;4:213-26||||||<0.001
71719918|NCT00325130|142955485|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719919|NCT00325130|142955486|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719920|NCT00325130|142955487|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71887447|NCT01337973|143295796|SUPERIORITY||||||<|0.001||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.69||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline||||<0.001
71719921|NCT00325130|142955488|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719922|NCT00325130|142955489|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719923|NCT00325130|142955490|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719924|NCT00325130|142955491|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719925|NCT00325130|142955492|NON_INFERIORITY_OR_EQUIVALENCE|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||95.0||||Since p\<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.||||||<0.001
71719926|NCT00326001|142955493|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value not adjusted for multiple comparisons|t-test, 2 sided|||||||0.25
71719927|NCT00326001|142955494|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Chi-squared|||||||0.042
71719928|NCT00326001|142955495|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||||||0.53
71719929|NCT00326001|142955496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71768880|NCT00420641|143038028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8782|TWO_SIDED|90.0|0.62|1.5|||Regression, Logistic|||Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.||1.50|0.62|0.8782
71719930|NCT03046927|142955512|EQUIVALENCE|p values were obtained using generalized linear model with GEE for repeated measures.|Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED||||||generalized linear model with dependent||Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.001
71719931|NCT03046927|142955513|OTHER||trend analysis|0.04|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|Trend analysis was performed using generalized linear model with GEE for repeated measures.|||||<0.01
71768881|NCT00420641|143038028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0011|TWO_SIDED|90.0|1.56|3.86|||Regression, Logistic|||Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.||3.86|1.56|0.0011
71719932|NCT03046927|142955514|OTHER|p values were derived from trend analysis using generalized linear models|Mean Difference (Net)|0.507||||0.0241|TWO_SIDED|95.0|0.066|0.947||The p-value was derived from a statistical model adjusted for age, sex, and BMI|General linear models|||||0.947|0.066|0.0241
71719933|NCT03046927|142955515|OTHER|p values were obtained from a generalized linear model with repeated measures|Mean Difference (Net)|10.37||||0.23|TWO_SIDED|95.0|-6.4|27.13||The p-value was derived from a statistical model adjusted for age, sex, and BMI|Regression, Linear|||||27.13|-6.40|0.23
71719934|NCT03046927|142955516|OTHER||trend analysis|0.02|||<|0.001|TWO_SIDED||||||generalized linear model|p values were obtained using generalized linear model with GEE for repeated measures.|||Trend analysis was obtained using generalized linear model GEE.|||<0.001
71719935|NCT01530178|142955592|OTHER|Non-specified|Mean Difference (Final Values)|-27.91||||0.003|TWO_SIDED|95.0|-44.7|-11.2|||ANOVA|||||-11.2|-44.7|0.003
71719936|NCT01530178|142955592|OTHER|Non-specified|Mean Difference (Final Values)|-2.131||||0.68|TWO_SIDED|95.0|-12.91|8.652|||ANOVA|||||8.652|-12.91|0.68
71719937|NCT01530178|142955592|OTHER||Mean Difference (Final Values)|-25.78||||0.0005|TWO_SIDED|95.0|-38.39|-13.17|||ANOVA|||||-13.17|-38.39|0.0005
71719938|NCT01734785|142955609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.93|-0.46|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.46|-0.93|<0.0001
71719939|NCT01734785|142955609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.02|-0.55|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) \& baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-0.55|-1.02|<0.0001
71768882|NCT02815280|143038040|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|1.12||0.0051|TWO_SIDED|95.0|0.95|5.35|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, baseline inflammatory lesion count and pooled investigational site as a blocking factor.||5.35|0.95|0.0051
71768883|NCT02815280|143038041|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0.|Risk ratio|1.88|STANDARD_ERROR_OF_MEAN|0.31||0.0424|TWO_SIDED|95.0|1.02|3.46|||Mantel Haenszel|||||3.46|1.02|0.0424
71768884|NCT02815280|143038042|SUPERIORITY||Mean Difference (Final Values)|12.84|STANDARD_ERROR_OF_MEAN|5.3||0.0155|TWO_SIDED|95.0|2.44|23.23||Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|ANCOVA|||||23.23|2.44|0.0155
71719940|NCT01734785|142955610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.61|-1.57|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.57|-2.61|<0.0001
71719941|NCT01734785|142955610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001||95.0|-2.31|-1.28|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.28|-2.31|<0.0001
71719942|NCT01734785|142955611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-2.92|-1.52|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-1.52|-2.92|<0.0001
71719943|NCT01734785|142955611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|-3.47|-2.07|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).||-2.07|-3.47|<0.0001
71719944|NCT00293813|142955620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||||95.0|2.6|5.7|||ANCOVA|||||5.7|2.6|
71719945|NCT00293813|142955620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||||95.0|-0.6|2.6|||ANCOVA|||||2.6|-.6|
71768885|NCT02815280|143038043|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.89|STANDARD_ERROR_OF_MEAN|1.03||0.0001|TWO_SIDED|95.0|1.88|5.9|||ANCOVA|||||5.90|1.88|0.0001
71768886|NCT02815280|143038043|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.78|STANDARD_ERROR_OF_MEAN|1.11||0.0007|TWO_SIDED|95.0|1.6|5.95|||ANCOVA|||||5.95|1.60|0.0007
71768887|NCT02815280|143038044|SUPERIORITY|P-value is for the null hypothesis that the combined log (Risk Ratio) equals 0. Percentage of participants achieving IGA treatment success at Week 6.|Risk Difference (RD)|3.87|STANDARD_ERROR_OF_MEAN|1.44||0.0071|TWO_SIDED|95.0|1.06|6.69|||Cochran-Mantel-Haenszel|||||6.69|1.06|0.0071
71768888|NCT02815280|143038044|SUPERIORITY||Risk Difference (RD)|1.64|STANDARD_ERROR_OF_MEAN|2.52||0.5143|TWO_SIDED|95.0|-3.3|6.58|||Cochran-Mantel-Haenszel|||||6.58|-3.30|0.5143
71768889|NCT00603642|143038046|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71768890|NCT00603642|143038047|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71768891|NCT00603642|143038048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANCOVA|||||||0.0003
71768892|NCT00603642|143038049|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71768893|NCT00603642|143038050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6015|||||||Fisher Exact|||||||0.6015
71768894|NCT02514473|143038066|SUPERIORITY||Least Square (LS) Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.75|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM). The model included treatment, visit and treatment-by-visit interaction as fixed effects; and participant as a random effect with adjustments for baseline, weight (less than \[\<\] 25 kilogram \[kg\] versus greater than or equal to \[\>=\] 25 kg) and percent predicted forced expiratory volume in 1 second (FEV1) severity (\<90 versus \>=90) at screening.||-0.75|-1.43|< 0.0001
71768895|NCT01607203|143038089|NON_INFERIORITY_OR_EQUIVALENCE|t -test||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
71768896|NCT00924170|143038112|SUPERIORITY||||||<|0.0001|||||||Kaplan Meier|||Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.||||<0.0001
71768897|NCT00579436|143038126|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
71768898|NCT00579436|143038127|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71768899|NCT00579436|143038128|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
71768900|NCT00579436|143038129|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
71768901|NCT02312882|143038152|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71768902|NCT02025556|143038153|SUPERIORITY||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-4.07|-1.55||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.55|-4.07|< .0001
71768903|NCT02025556|143038153|SUPERIORITY||Mean Difference (Final Values)|-2.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-3.9|-1.38||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.38|-3.9|< .0001
71768904|NCT01203852|143038168|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test of mean change in blood pressure before and after treatment with metoprolol and chlorthalidone were \<0.0001.|t-test, 1 sided|||||||<0.0001
71768905|NCT01203852|143038169|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with chlorthalidone was \<0.0001.|t-test, 1 sided|||Mean glucose change after treatment with chlorthalidone||||<0.0001
71719946|NCT01139411|142955622|SUPERIORITY_OR_OTHER|||||||0.06||||||Threshold for significance: 0.05|ANCOVA|||"Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate."||||0.06
71719947|NCT01139411|142955623|SUPERIORITY_OR_OTHER|||||||0.58||||||Threshold for significance: 0.05|ANCOVA|||The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.||||0.58
71719948|NCT01139411|142955624|SUPERIORITY_OR_OTHER|||||||0.19||||||Threshold for significance: 0.05|ANCOVA|||||||0.19
71719949|NCT01139411|142955625|SUPERIORITY_OR_OTHER|||||||0.72||||||Threshold for significance: 0.05|ANCOVA|||||||0.72
71719950|NCT01139411|142955626|SUPERIORITY_OR_OTHER|||||||0.41|||||||ANCOVA|||||||0.41
71719951|NCT01139411|142955627|SUPERIORITY_OR_OTHER|||||||0.01||||||Threshold for significance: 0.05|ANCOVA|||||||0.01
71719952|NCT01139411|142955628|SUPERIORITY_OR_OTHER|||||||0.61||||||Threshold for significance: 0.05|ANCOVA|||||||0.61
71719953|NCT01521923|142955629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.719|||=|0.112|TWO_SIDED|95.0|0.881|3.354|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level||3.354|0.881|=0.112
71719954|NCT01521923|142955629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.889|||=|0.041|TWO_SIDED|95.0|1.026|3.48|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level||3.480|1.026|=0.041
71768906|NCT01203852|143038169|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||P-value for one sided t-test for mean glucose change before and after treatment with metoprolol was 0.049.|t-test, 1 sided|||Mean glucose change after treatment with metoprolol||||0.049
71719955|NCT04830215|142955695|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
71719956|NCT04830215|142955696|OTHER||||||<|0.0001||||||MMRM included fixed effect terms for visit, baseline value, an interaction term of baseline value by visit, and trial center.|MMRM|||||||<0.0001
71719957|NCT03994211|142955718|OTHER||Geometric Mean Ratio Estimate|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||||1.06|0.83|
71719958|NCT03994211|142955719|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.95|1.15||||||||1.15|0.95|
71719959|NCT03994211|142955720|OTHER||Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.54|0.7||||||||0.70|0.54|
71719960|NCT03994211|142955721|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.09||||||||1.09|0.91|
71719961|NCT03994211|142955722|OTHER||Geometric Mean Ratio|0.57|||||TWO_SIDED|90.0|0.48|0.69||||||||0.69|0.48|
71719962|NCT03994211|142955723|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.9|1.09||||||||1.09|0.90|
71719963|NCT04677543|142955764|SUPERIORITY||Percentage Difference|10.4||||0.2819|TWO_SIDED|95.0|-8.6|29.5|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||29.5|-8.6|0.2819
71719964|NCT04677543|142955765|SUPERIORITY||Percentage Difference|6.1||||0.508|TWO_SIDED|95.0|-11.9|24.1|||Standardized Logistic Regression||The percentage difference and confidence intervals are estimated by standardized logistic regression with treatment group and history of MAC lung infection as factors in the model.|||24.1|-11.9|0.5080
71719965|NCT04677543|142955766|SUPERIORITY||Percentage Difference|16.7||||0.0712|TWO_SIDED|95.0|-1.4|34.9|||Standardized Logistic Regression|||||34.9|-1.4|0.0712
71719966|NCT04677543|142955767|SUPERIORITY||Least Square Mean Difference|4.48||||0.1073|TWO_SIDED|95.0|-0.97|9.93|||ANCOVA|||||9.93|-0.97|0.1073
71719967|NCT04677543|142955768|SUPERIORITY||Least Square Mean Difference|-0.4||||0.613|TWO_SIDED|95.0|-2.2|1.3|||ANCOVA|||||1.3|-2.2|0.6130
71719968|NCT04677543|142955769|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3542|TWO_SIDED|95.0|0.79|1.92|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||1.92|0.79|0.3542
71719969|NCT04677543|142955770|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.1583|TWO_SIDED|95.0|0.89|2.06|||Regression, Cox||A Cox regression model was applied to calculate the hazard ratio. The model included effects for treatment and history of MAC lung infection (initial or subsequent).|||2.06|0.89|0.1583
71719970|NCT02110485|142955778|SUPERIORITY|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71719971|NCT02110485|142955779|OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.27
71719972|NCT02110485|142955780|OTHER|||||||0.67|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.67
71719973|NCT02110485|142955781|OTHER|||||||0.17|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.17
71719974|NCT02110485|142955782|OTHER|||||||0.84|||||||Fisher Exact|||||||.84
71719975|NCT02110485|142955783|OTHER|||||||0.99|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.99
71719976|NCT00995436|142955784|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.53|0.36|||||Maxillary right molar|||0.36|-1.53|
71719977|NCT00995436|142955784|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.89|-0.04|||||Maxillary left molar|||-0.04|-1.89|
71768907|NCT00247611|143038171|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance were 0.05 alpha two tailed.|HLM|||For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.||||0.12
71719978|NCT00995436|142955784|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|0.62|||||TWO_SIDED|95.0|-0.32|1.55|||||Maxillary right molar|||1.55|-0.32|
71719979|NCT00995436|142955784|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-1.0|0.83|||||Maxillary left molar|||0.83|-1|
71719980|NCT00995436|142955784|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.05||||||Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.|ANCOVA|||||||0.05
71719981|NCT00995436|142955784|NON_INFERIORITY_OR_EQUIVALENCE|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.08||||||Overall effect of treatment F(2,67) = 2.58.|ANCOVA|||Maxillary left molar.||||0.08
71719982|NCT02063984|142955791|SUPERIORITY||Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.11|1.56|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||1.56|.11|
71719983|NCT02063984|142955792|SUPERIORITY||Ratio of means|1.56|||||TWO_SIDED|95.0|0.79|3.07|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||3.07|.79|
71719984|NCT02063984|142955793|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.18|4.82||||||CM+No WMT is the comparison condition||4.82|.18|
71768908|NCT00247611|143038171|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||The p-value was not adjusted for multiple comparisons, and thresholds for significance was 0.05 alpha, two tailed.|HLM|||For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.||||0.024
71829578|NCT02027558|143163290|SUPERIORITY||Mean Difference (Net)|-20.46|STANDARD_ERROR_OF_MEAN|8.75||0.019|TWO_SIDED|95.0|-37.63|-3.29|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||-3.29|-37.63|0.019
71829579|NCT02027558|143163291|SUPERIORITY||Mean Difference (Net)|10.49|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|4.53|16.44|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||16.44|4.53|0.001
71887448|NCT01337973|143295796|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.32||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline||||<0.01
71829580|NCT02027558|143163292|SUPERIORITY||Mean Difference (Net)|4.35|STANDARD_ERROR_OF_MEAN|1.26||0.001|TWO_SIDED|95.0|1.87|6.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.|||6.83|1.87|0.001
71719985|NCT02063984|142955794|SUPERIORITY||Ratio of means|0.92|||||TWO_SIDED|95.0|0.33|2.54|||||Outcome was tested in a zero-inflated negative binomial (ZINB) model|CM+No WMT is the comparison condition||2.54|.33|
71719986|NCT02063984|142955795|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.45||||||Strategy 1 is the comparison condition||2.45|.45|
71719987|NCT02063984|142955795|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.84|6.2||||||Strategy 1 is the comparison condition||6.20|.84|
71719988|NCT02063984|142955795|SUPERIORITY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.23|1.13||||||Strategy 1 is the comparison condition||1.13|.23|
71719989|NCT02063984|142955796|SUPERIORITY||Ratio of means|1.21|||||TWO_SIDED|95.0|0.76|1.92||||||Strategy 1 is the comparison condition||1.92|.76|
71719990|NCT02063984|142955796|SUPERIORITY||Ratio of means|0.76|||||TWO_SIDED|95.0|0.49|1.18||||||Strategy 1 is the comparison condition||1.18|.49|
71719991|NCT02063984|142955796|SUPERIORITY||Ratio of means|1.33|||||TWO_SIDED|95.0|0.83|2.15||||||Strategy 1 is the comparison condition||2.15|.83|
71719992|NCT03674970|142955797|OTHER|||||||0.55|||||||ANOVA|||||||.55
71719993|NCT03674970|142955798|OTHER|||||||0.2146|||||||ANOVA|||||||.2146
71719994|NCT03674970|142955799|OTHER|||||||0.5642|||||||ANOVA|||||||.5642
71719995|NCT03674970|142955800|OTHER|||||||0.4353|||||||ANOVA|||||||.4353
71719996|NCT03674970|142955801|OTHER|||||||0.0348|||||||ANOVA|||||||.0348
71719997|NCT03674970|142955802|OTHER|||||||0.404|||||||ANOVA|||||||.4040
71719998|NCT03299244|142955806|NON_INFERIORITY|Etelcalcetide was considered non-inferior if the upper bound of the two-sided 95% confidence interval of the treatment difference (Cinacalcet - Etelcalcetide) was smaller than 12%, or if the lower bound of (Etelcalcetide - Cinacalcet) greater than -12%. If this criterion was met, the 2 key secondary endpoints were tested sequentially. If both key secondary endpoints were statistically significant, the other secondary endpoints were to be formally tested at an overall significance level of 0.05.|Treatment Difference|4.52|||||TWO_SIDED|95.0|-3.05|12.09|||||Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|"The analysis was conducted on the full analysis set (637 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment (Cinacalcet - Etelcalcetide), stratified by screening PTH level (\< 900 pg/mL, ≥ 900 pg/mL), screening serum cCa (\< 9.0 mg/dL, ≥ 9.0 mg/dL) measured by the central laboratory, and country (China versus non-China)."||12.09|-3.05|
71768909|NCT00247611|143038172|SUPERIORITY_OR_OTHER||||||>|0.5||95.0||||No adjustments were made.|Generalized Linear Model (GLM)|||For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p \> 0.50. The study was underpowered to detect differences in Viral load.||||>0.50
71829581|NCT02027558|143163293|SUPERIORITY||Mean Difference (Final Values)|-17.42|STANDARD_ERROR_OF_MEAN|4.99||0.0007|TWO_SIDED|95.0|-27.29|-7.55|||t-test, 2 sided|||||-7.55|-27.29|0.0007
71719999|NCT03299244|142955807|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.47|2.77|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||2.77|1.47|<0.001
71720000|NCT03299244|142955808|SUPERIORITY|Testing of this key secondary efficacy endpoint at an overall significance level of 0.05 was to be performed if non-inferiority was demonstrated for the primary endpoint, and superiority was demonstrated for the previous key secondary endpoint.|Odds Ratio (OR)|1.42||||0.033|TWO_SIDED|95.0|1.03|1.96|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.96|1.03|0.033
71720001|NCT03299244|142955809|SUPERIORITY||Difference in Least Squares Means|-2.82|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-4.14|-1.5|||Mixed-effects Model Repeated Measures|Model includes treatment group, randomization stratification factors, study week, and study week by treatment as covariates.|Treatment difference (Etelcalcetide - Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region. Standard error of the mean is the standard error of the least squares means difference.|||-1.50|-4.14|<0.001
71720002|NCT03299244|142955810|SUPERIORITY||Odds Ratio (OR)|1.16||||0.41|TWO_SIDED|95.0|0.82|1.65|||Cochran-Mantel-Haenszel|CMH test stratified by screening iPTH level, screening cCa level, and country/region.|Odds ratio (Etelcalcetide : Cinacalcet) stratified by screening iPTH level, screening cCa level, and country/region.|||1.65|0.82|0.41
71720003|NCT02227810|142955846|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
71720004|NCT02227810|142955846|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
71720005|NCT02227810|142955847|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||||||0.051
71720006|NCT02227810|142955847|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71720007|NCT02227810|142955848|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 2 sided|||||||0.051
71720008|NCT02227810|142955849|SUPERIORITY_OR_OTHER|||||||0.792|||||||t-test, 2 sided|||||||0.792
71720009|NCT03063606|142955853|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.0002|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.0002
71720010|NCT03063606|142955854|SUPERIORITY|||||||0.83||||||Analyses used all available data. Analyses to compare treatments were all intent-to-treat.|Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session.||||||.83
71720011|NCT03079531|142955864|OTHER|||||||0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there would be no difference in papule/pustule count at baseline and after 16 weeks of secukinumab; the alternative hypothesis is that there would be a difference. Using an alpha=0.05 and power=0.80 (two sided test), the sample size needed would be 20. Assuming a dropout rate of 20%, 24 patients would be needed to achieve sufficient sample size.||||0.01
71720012|NCT03079531|142955865|OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
71720013|NCT03079531|142955866|OTHER|||||||0.03|||||||Wilcoxon signed rank test|||||||0.03
71720014|NCT03079531|142955867|OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
71720015|NCT03079531|142955868|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71720016|NCT03079531|142955870|OTHER|||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
71720017|NCT03265145|142955888|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.87|1.72|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||1.72|0.87|
71720018|NCT03265145|142955889|OTHER||adjusted annual rate ratio|1.41|||||TWO_SIDED|95.0|0.97|2.04|||||Ratio: Stiolto Respimat/triple therapy|||2.04|0.97|
71720019|NCT03265145|142955890|OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.62|2.0|||||"Cox proportional hazards model with baseline ICS prior use as a covariate was used to estimate the hazard ratio (HR) and the two-sided 95% Wald confidence interval (CI).~Ratio: Stiolto Respimat/triple therapy."|||2.00|0.62|
71720020|NCT03265145|142955891|OTHER||adjusted annual rate ratio|1.08|||||TWO_SIDED|95.0|0.58|2.01|||||Ratio: Stiolto Respimat/triple therapy|||2.01|0.58|
71720021|NCT03265145|142955892|OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Ratio (RR) (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||1.64|0.89|
71720022|NCT03265145|142955892|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.022|0.094|||||Ratio: Stiolto Respimat/triple therapy|A Cochran-Mantel-Haenszel (CMH) model with baseline ICS prior use as stratum was used to estimate the Risk Difference (Stiolto Respimat versus triple therapy) of moderate or severe COPD exacerbations along with 95% CI.||0.094|-0.022|
71720023|NCT03159468|142955893|OTHER|||||||0.041||||||This p-value is for the main effect of beverage condition.|ANOVA|||||||.041
71720024|NCT03159468|142955893|OTHER|||||||0.16||||||This p-value is for the main effect of intervention condition.|ANOVA|||||||.160
71720025|NCT03159468|142955893|OTHER|||||||0.462||||||This p-value is for the beverage condition by intervention condition interaction.|ANOVA|||||||.462
71720026|NCT00802997|142955894|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
71720027|NCT01848977|142955958|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Unpaired t-test was used to compare the difference between SrO2 and StO2.||||<0.05
71720028|NCT02522429|142956055|OTHER|||||||0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7)|t-test, 1 sided|||||||0.05
71720029|NCT02522429|142956056|OTHER||||||<|0.05||||||Statistic adjusted at familywise level alpha of 0.05 with a Gaussian Random Field Cluster Correction (Z \> 2.7). All significant voxels have an associated p-value smaller-or-equal to 0.05 (corrected for multiplicity).|t-test, 1 sided|||||||<0.05
71720030|NCT02522429|142956058|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Maximum CRS-R prior to LIFUP compared to Maximum CRS-R after LIFUP||||<0.05
71829582|NCT03622580|143163379|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-2.0|1.6|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|
71829583|NCT03622580|143163379|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|97.5|-1.1|2.5|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|
71829584|NCT03622580|143163379|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95||0.4699|TWO_SIDED|97.5|-2.8|1.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||1.4|-2.8|0.4699
71829585|NCT03622580|143163379|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.94||0.965|TWO_SIDED|97.5|-2.1|2.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.2|-2.1|0.9650
71829586|NCT03622580|143163379|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.7967|TWO_SIDED|97.5|-2.0|1.6||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||1.6|-2.0|0.7967
71829587|NCT03622580|143163379|SUPERIORITY||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.79||0.3772|TWO_SIDED|97.5|-1.1|2.5||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.5|-1.1|0.3772
71829588|NCT03622580|143163380|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|10.2|||||TWO_SIDED|97.5|0.3|20.0||||||The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|
71887449|NCT01337973|143295796|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.90||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline||||<0.01
71887450|NCT01337973|143295796|SUPERIORITY||||||>|0.05||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -1.02||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline||||>0.05
71887451|NCT01337973|143295796|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -4.01||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline||||<0.01
71887452|NCT01337973|143295796|SUPERIORITY||||||<|0.01||||||The threshold for significance was p \< 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.21||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline||||<0.01
71768910|NCT00247611|143038173|SUPERIORITY_OR_OTHER|||||||0.12||0.0||||The p-value was not adjusted for multiple comparisons and is reported as 0.12 at alpha 0.05 two tailed|HLM|||For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
71720031|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.56|||||Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus \[-\] Vax 1).|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.56|0.28|
71720032|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.67|
71720033|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.44|0.72|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.72|0.44|
71720034|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.53|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.53|0.32|
71720035|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.45|0.91|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.91|0.45|
71720036|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.56|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.01|0.56|
71720037|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.25|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.25|
71768911|NCT00247611|143038173|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed.|HLM|||For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.||||0.12
71768912|NCT00247611|143038174|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.001
71768913|NCT00247611|143038174|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.||||<0.01
71720038|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.16|0.4|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.40|0.16|
71720039|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.4|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.78|0.40|
71768914|NCT02589600|143038185|SUPERIORITY||Incident Rate Ratio|1.05||||0.7251|TWO_SIDED|95.0|0.9|1.22|||Negative binomial regression||Placebo group is the reference group||Negative binomial regression implemented in the SAS®️ GENMOD procedure with fracture outcome as the dependent variable; duration of follow-up as an offset to account for each participant's exposure; treatment arm as the main independent factor of interest.|1.22|.90|0.7251
71768915|NCT01816451|143038192|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre-post training variables data were expressed as mean and standard deviation. Heart Rate and Blood Lactate, were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables absolute and relative VO2, tVO2, Body Fat, Body Mass, RPE, were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used.||||< 0.05
71720040|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.65|0.40|
71720041|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.48|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.48|0.30|
71720042|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.67|0.35|
71768916|NCT01816451|143038192|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post training data were expressed as mean and standard deviation. HR and \[La\], were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables RPE, Velocity were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used. Control didn't do submaximal test for training intensities.||||<0.05
71768917|NCT00481507|143038209|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82|||>|0.05|TWO_SIDED|95.0|0.54|1.43||Reply: Only one test was performed for the primary outcome. No covariates were entered into this model and p-value is unadjusted.|Chi-squared|The results obtained from the logistic regression are equivalent to the chi-square test with one degree of freedom.||Reply: The null hypothesis was the rates of diarrhea for Kefir vs. Placebo are not different. Post power calculation was not performed because the difference observed (21.9% vs. 18%) was less than a difference that which would be considered clinically important.||1.43|0.54|>.05
71768918|NCT00545129|143038251|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.45||0.569|TWO_SIDED|95.0|-1.18|0.66|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. Least squares (LS) mean difference, and corresponding 95% confidence interval (CI) were estimated from ANCOVA model.||0.66|-1.18|0.569
71768919|NCT00545129|143038252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.581|TWO_SIDED|95.0|-0.6|0.34|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.34|-0.60|0.581
71768920|NCT00545129|143038252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.795|TWO_SIDED|95.0|-0.56|0.73|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-0.56|0.795
71768921|NCT00545129|143038252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.41||0.843|TWO_SIDED|95.0|-0.76|0.93|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.93|-0.76|0.843
71768922|NCT00545129|143038252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.43||0.292|TWO_SIDED|95.0|-1.34|0.42|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.42|-1.34|0.292
71720043|NCT00500357|142956062|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.86|1.86|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.86|0.86|
71768923|NCT00545129|143038253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
71768924|NCT00545129|143038253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
71829589|NCT03622580|143163380|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -10%, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W.|Difference in CMH Weighted Percentage|6.1|||||TWO_SIDED|97.5|-3.6|15.8||||||The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|
71720044|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.57|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.57|0.34|
71720045|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.95|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.95|0.66|
71720046|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.76|1.22|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.22|0.76|
71720047|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.8|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.80|0.57|
71720048|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.39|2.84|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||2.84|1.39|
71720049|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.11|1.63|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.63|1.11|
71720050|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.18|0.41|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.41|0.18|
71720051|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.27|
71720052|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.83|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.83|0.57|
71720053|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|1.03|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.03|0.66|
71768925|NCT00545129|143038253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED|95.0|-0.74|0.98|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.98|-0.74|0.776
71768926|NCT00545129|143038253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.45||0.978|TWO_SIDED|95.0|-0.93|0.91|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.93|0.978
71768927|NCT00545129|143038253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.689|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.73|-1.10|0.689
71768928|NCT00545129|143038254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.23||0.299|TWO_SIDED|95.0|-0.72|0.23|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.23|-0.72|0.299
71768929|NCT00545129|143038254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.34||0.519|TWO_SIDED|95.0|-0.47|0.91|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.91|-0.47|0.519
71768930|NCT00545129|143038254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.618|TWO_SIDED|95.0|-0.68|1.13|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.13|-0.68|0.618
71720054|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.58|
71829590|NCT03622580|143163380|SUPERIORITY||Difference in CMH Weighted Percentage|7.2||||0.1761|TWO_SIDED|97.5|-4.6|18.9||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||18.9|-4.6|0.1761
71829591|NCT03622580|143163380|SUPERIORITY||Difference in CMH Weighted Percentage|4.8||||0.3539|TWO_SIDED|97.5|-6.7|16.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||16.3|-6.7|0.3539
71720055|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.73|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.73|0.47|
71720056|NCT00500357|142956065|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.94|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.94|1.18|
71720057|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.65|||||TWO_SIDED|95.0|0.52|0.82|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.82|0.52|
71720058|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.52|||||TWO_SIDED|95.0|0.43|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.62|0.43|
71720059|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.63|||||TWO_SIDED|95.0|0.53|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.76|0.53|
71720060|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.32|||||TWO_SIDED|95.0|0.27|0.39|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.39|0.27|
71720061|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||1.10|0.74|
71720062|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.99|0.63|
71720063|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.72|||||TWO_SIDED|95.0|0.6|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.87|0.60|
71720064|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.6|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.60|0.42|
71720065|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.59|0.98|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.98|0.59|
71720066|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.38|||||TWO_SIDED|95.0|0.31|0.46|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.46|0.31|
71829592|NCT03622580|143163380|SUPERIORITY||Difference in CMH Weighted Percentage|10.2||||0.0237|TWO_SIDED|97.5|0.3|20.0||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||20.0|0.3|0.0237
71829593|NCT03622580|143163380|SUPERIORITY||Difference in CMH Weighted Percentage|6.1||||0.1677|TWO_SIDED|97.5|-3.6|15.8||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||15.8|-3.6|0.1677
71720067|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.74|0.49|
71720068|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.64|||||TWO_SIDED|95.0|0.52|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.79|0.52|
71720069|NCT00500357|142956066|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.||0.93|0.62|
71720070|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.6|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.78|0.60|
71720071|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.64|0.48|
71720072|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.75|||||TWO_SIDED|95.0|0.65|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.87|0.65|
71720073|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.61|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.76|0.61|
71720074|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.49|||||TWO_SIDED|95.0|1.27|1.75|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.75|1.27|
71768931|NCT00545129|143038254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.818|TWO_SIDED|95.0|-0.85|1.07|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.07|-0.85|0.818
71768932|NCT00545129|143038254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.48||0.819|TWO_SIDED|95.0|-0.87|1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.09|-0.87|0.819
71768933|NCT00545129|143038255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.34||0.906|TWO_SIDED|95.0|-0.66|0.74|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.74|-0.66|0.906
71768934|NCT00545129|143038255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.906|TWO_SIDED|95.0|-0.95|0.85|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.85|-0.95|0.906
71720075|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.07|||||TWO_SIDED|95.0|0.94|1.21|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.21|0.94|
71720076|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.68|||||TWO_SIDED|95.0|0.58|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.79|0.58|
71720077|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.68|0.53|
71768935|NCT00545129|143038255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.613|TWO_SIDED|95.0|-0.78|1.29|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.29|-0.78|0.613
71768936|NCT00545129|143038255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.46||0.988|TWO_SIDED|95.0|-0.95|0.94|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.94|-0.95|0.988
71768937|NCT00545129|143038255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.47||0.922|TWO_SIDED|95.0|-1.01|0.92|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.92|-1.01|0.922
71829594|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|95.0|-10.0|4.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.9|-10.0|
71720078|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.59|||||TWO_SIDED|95.0|0.51|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.67|0.51|
71720079|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.67|||||TWO_SIDED|95.0|0.6|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.74|0.60|
71720080|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.78|||||TWO_SIDED|95.0|0.69|0.88|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.88|0.69|
71720081|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.54|||||TWO_SIDED|95.0|0.47|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||0.62|0.47|
71720082|NCT00500357|142956067|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.06|||||TWO_SIDED|95.0|0.9|1.25|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.||1.25|0.90|
71720083|NCT00161616|142956068|SUPERIORITY_OR_OTHER|||||||0.0541|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 13.||||0.0541
71720084|NCT00161616|142956068|SUPERIORITY_OR_OTHER|||||||0.7983|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 20.||||0.7983
71720085|NCT00161616|142956069|SUPERIORITY_OR_OTHER|||||||0.8961|||||||Fisher Exact|||||||0.8961
71720086|NCT00861757|142956077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.003|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|||||-0.6|-3.0|0.003
71720087|NCT00861757|142956077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.9|-0.6|||ANCOVA|||||-0.6|-2.9|0.004
71720088|NCT00861757|142956077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.7|-1.3|||ANCOVA|||||-1.3|-3.7|<0.001
71720089|NCT00861757|142956078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.6||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.6|-2.2|<0.001
71720090|NCT00861757|142956078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.005|TWO_SIDED|95.0|-1.9|-0.3||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-0.3|-1.9|0.005
71720091|NCT00861757|142956078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.1||This is the p value for the Voiding (Obstructive) Score.|ANCOVA|||||-1.1|-2.7|<0.001
71720092|NCT00861757|142956078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.072|TWO_SIDED|95.0|-1.0|0.0||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||0.0|-1.0|0.072
71720093|NCT00861757|142956078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.021|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.021
71720094|NCT00861757|142956078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.023|TWO_SIDED|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA|||||-0.1|-1.1|0.023
71720095|NCT00861757|142956079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.031
71720096|NCT00861757|142956079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.013
71720097|NCT00861757|142956079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||||-0.4|-0.9|<0.001
71720098|NCT00861757|142956080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.201
71768938|NCT00545129|143038256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.4||0.655|TWO_SIDED|95.0|-1.03|0.66|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.66|-1.03|0.655
71768939|NCT00545129|143038256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.44||0.897|TWO_SIDED|95.0|-0.85|0.96|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.96|-0.85|0.897
71768940|NCT00545129|143038256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.798|TWO_SIDED|95.0|-0.93|1.2|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.20|-0.93|0.798
71720099|NCT00861757|142956080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.393|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.393
71720100|NCT00861757|142956080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.4|-0.2|||ANCOVA|||||-0.2|-1.4|0.007
71720101|NCT00861757|142956081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.331|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||||0.5|-1.6|0.331
71720102|NCT00861757|142956081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.14|TWO_SIDED|95.0|-1.8|0.3|||ANCOVA|||||0.3|-1.8|0.140
71720103|NCT00861757|142956081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||||1.0|-1.1|0.940
71720104|NCT00861757|142956082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
71720105|NCT00861757|142956082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
71720106|NCT00861757|142956082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel|||||||<0.001
71720107|NCT00861757|142956083|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.034
71768941|NCT00545129|143038256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.51||0.672|TWO_SIDED|95.0|-0.83|1.27|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.27|-0.83|0.672
71768942|NCT00545129|143038256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.48||0.243|TWO_SIDED|95.0|-1.56|0.41|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.41|-1.56|0.243
71768943|NCT00545129|143038257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.41||0.445|TWO_SIDED|95.0|-1.16|0.52|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.52|-1.16|0.445
71829595|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
71829596|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-8.6|7.9||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||7.9|-8.6|
71720108|NCT00861757|142956083|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.002
71720109|NCT00861757|142956083|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel|||||||0.001
71829597|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-7.4|8.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.8|-7.4|
71829598|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|-2.5|||||TWO_SIDED|95.0|-9.1|4.1||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.1|-9.1|
71720110|NCT00861757|142956084|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.412
71720111|NCT00861757|142956084|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.083
71720112|NCT00861757|142956084|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.456
71720113|NCT00861757|142956085|SUPERIORITY_OR_OTHER|||||||0.688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.688
71720114|NCT00861757|142956085|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.510
71829599|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-8.5|4.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.5|-8.5|
71829600|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-4.6|4.8||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.8|-4.6|
71720115|NCT00861757|142956085|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.212
71720116|NCT00861757|142956086|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.005
71720117|NCT00861757|142956086|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.274
71829601|NCT03622580|143163383|OTHER||Difference in CMH Weighted Percentage|3.3|||||TWO_SIDED|95.0|-1.0|7.5||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.5|-1.0|
71720118|NCT00861757|142956086|SUPERIORITY_OR_OTHER|||||||0.538||95.0||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.538
71720119|NCT00861757|142956086|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.008
71720120|NCT00861757|142956086|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.216
71720121|NCT00861757|142956086|SUPERIORITY_OR_OTHER|||||||0.524||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)|||||||0.524
71720122|NCT00861757|142956087|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.007
71829602|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|-5.2|||||TWO_SIDED|95.0|-14.0|3.5||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||3.5|-14.0|
71720123|NCT00861757|142956087|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.723
71720124|NCT00861757|142956087|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test|||||||0.273
71720125|NCT00861757|142956087|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.005
71720126|NCT00861757|142956087|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.054
71720127|NCT00861757|142956087|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test|||||||0.278
71720128|NCT00861757|142956088|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon rank-sum test|||||||0.330
71829603|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-7.0|10.3||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||10.3|-7.0|
71829604|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-9.5|9.5||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||9.5|-9.5|
71829605|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|2.1|||||TWO_SIDED|95.0|-7.1|11.3||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||11.3|-7.1|
71720129|NCT00861757|142956088|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||Wilcoxon rank-sum test|||||||0.838
71720130|NCT00861757|142956088|SUPERIORITY_OR_OTHER|||||||0.409||95.0|||||Wilcoxon rank-sum test|||||||0.409
71720131|NCT01709110|142956100|SUPERIORITY||Odds Ratio (OR)|0.4071||||9.4e-05|TWO_SIDED|95.0|0.256|0.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.647|0.256|0.000094
71720132|NCT01709110|142956100|SUPERIORITY||Risk Ratio (RR)|0.4431||||9.4e-05|TWO_SIDED|95.0|0.29|0.677|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.677|0.290|0.000094
71720133|NCT01709110|142956101|SUPERIORITY||Odds Ratio (OR)|0.4187||||7.5e-05|TWO_SIDED|95.0|0.269|0.652|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.652|0.269|0.000075
71720134|NCT01709110|142956101|SUPERIORITY||Risk Ratio (RR)|0.4561||||7.5e-05|TWO_SIDED|95.0|0.305|0.682|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.682|0.305|0.000075
71720135|NCT01709110|142956102|SUPERIORITY||Stratified Hazard Ratio (HR)|0.4831||||0.000869|TWO_SIDED|95.0|0.316|0.739|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||0.739|0.316|0.000869
71720136|NCT01709110|142956103|SUPERIORITY||Stratified Hazard Ratio (HR)|0.6553||||0.099023|TWO_SIDED|95.0|0.39|1.101|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.101|0.390|0.099023
71720137|NCT01709110|142956104|SUPERIORITY||Stratified Hazard Ratio (HR)|0.5786||||0.062432|TWO_SIDED|95.0|0.318|1.052|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.052|0.318|0.062432
71720138|NCT01709110|142956105|SUPERIORITY||Odds Ratio (OR)|0.3812|||<|0.001|TWO_SIDED|95.0|0.237|0.614|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.614|0.237|<0.001
71720139|NCT01709110|142956105|SUPERIORITY||Risk Ratio (RR)|0.4173|||<|0.001|TWO_SIDED|95.0|0.27|0.646|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.646|0.270|<0.001
71720140|NCT01709110|142956106|SUPERIORITY||Odds Ratio (OR)|0.1593||||0.007|TWO_SIDED|95.0|0.035|0.728|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.728|0.035|0.007
71720141|NCT01709110|142956106|SUPERIORITY||Risk Ratio (RR)|0.1643||||0.007|TWO_SIDED|95.0|0.036|0.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.||||0.744|0.036|0.007
71720142|NCT01709110|142956107|SUPERIORITY||Stratified Hazard Ratio (HR)|0.696||||0.078|TWO_SIDED|95.0|0.461|1.05|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.|||1.050|0.461|0.078
71829606|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|-4.5|||||TWO_SIDED|95.0|-11.9|2.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.9|-11.9|
71829607|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|-7.2|||||TWO_SIDED|95.0|-14.6|0.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||0.2|-14.6|
71829608|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-5.5|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-5.5|
71829609|NCT03622580|143163388|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-3.0|7.0||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||7.0|-3.0|
71720143|NCT01709110|142956108|SUPERIORITY||Least Squares Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.08||0.093|TWO_SIDED|95.0|-0.28|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.28|0.093
71720144|NCT01709110|142956109|SUPERIORITY||Least Squares Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.585|TWO_SIDED|95.0|-0.42|0.24||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain \[0-10\]).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.24|-0.42|0.585
71720145|NCT01709110|142956110|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.757|TWO_SIDED|95.0|-0.03|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.02|-0.03|0.757
71720146|NCT01709110|142956111|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.694|TWO_SIDED|95.0|-0.02|0.01||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.|||0.01|-0.02|0.694
71720147|NCT03332173|142956112|SUPERIORITY||||||<|0.0001||||||P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)|Exact binomial test|||Zanubrutinib versus historical control estimate of 30%||||<0.0001
71720148|NCT00910910|142956127|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.323|TWO_SIDED|90.0|0.88|1.66|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.66|0.88|0.323
71768944|NCT00545129|143038257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.992|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.00|-1.00|0.992
71768945|NCT00545129|143038257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.53||0.655|TWO_SIDED|95.0|-1.34|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.34|0.655
71768946|NCT00545129|143038257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.86|TWO_SIDED|95.0|-1.09|1.3|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.30|-1.09|0.860
71768947|NCT00545129|143038257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.59||0.595|TWO_SIDED|95.0|-1.52|0.89|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.89|-1.52|0.595
71768948|NCT00545129|143038258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.179|TWO_SIDED|95.0|-1.76|0.35|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.35|-1.76|0.179
71768949|NCT00545129|143038258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.938|TWO_SIDED|95.0|-1.02|1.1|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.10|-1.02|0.938
71829610|NCT03622580|143163393|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-2.8|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-2.8|
71829611|NCT03622580|143163393|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.2|1.5||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.5|-2.2|
71829612|NCT03622580|143163393|OTHER||Difference in CMH Weighted Percentage|-1.8|||||TWO_SIDED|95.0|-4.6|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-4.6|
71829613|NCT03622580|143163393|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.2|
71829614|NCT03622580|143163393|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-4.5|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-4.5|
71829615|NCT03622580|143163393|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-2.6|3.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.4|-2.6|
71829616|NCT03622580|143163397|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-3.5|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.5|
71720149|NCT00910910|142956128|SUPERIORITY||Cox Proportional Hazard|0.99||||0.967|TWO_SIDED|90.0|0.76|1.29||The p-value is based on a stratified log-rank test|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to \< 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )\> 4.0 mg/L (Yes versus No VS Unknown)||1.29|0.76|0.967
71829617|NCT03622580|143163397|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.1|1.3||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.3|-3.1|
71768950|NCT00545129|143038258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-1.41|0.86|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.86|-1.41|0.621
71829618|NCT03622580|143163397|OTHER||Difference in CMH Weighted Percentage|-2.1|||||TWO_SIDED|95.0|-5.1|0.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||0.9|-5.1|
71829619|NCT03622580|143163397|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-3.5|1.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.6|-3.5|
71768951|NCT00545129|143038258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.64||0.863|TWO_SIDED|95.0|-1.44|1.21|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||1.21|-1.44|0.863
71829620|NCT03622580|143163397|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-5.2|2.8||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.8|-5.2|
71829621|NCT03622580|143163397|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.1|3.3||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||3.3|-4.1|
71829622|NCT03622580|143163401|OTHER||Difference in CMH Weighted Percentage|-4.9|||||TWO_SIDED|95.0|-12.6|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-12.6|
71829623|NCT03622580|143163401|OTHER||Difference in CMH Weighted Percentage|2.0|||||TWO_SIDED|95.0|-5.9|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-5.9|
71829624|NCT03622580|143163401|OTHER||Difference in CMH Weighted Percentage|-8.6|||||TWO_SIDED|95.0|-17.8|0.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.5|-17.8|
71829625|NCT03622580|143163401|OTHER||Difference in CMH Weighted Percentage|-0.9|||||TWO_SIDED|95.0|-9.9|8.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||8.2|-9.9|
71720150|NCT00910910|142956131|SUPERIORITY||Odds Ratio (OR)|0.65||||0.032|TWO_SIDED|95.0|0.44|0.96|||Fisher Exact|||||0.96|0.44|0.032
71720151|NCT00910910|142956132|SUPERIORITY||Odds Ratio (OR)|0.66||||0.047|TWO_SIDED|95.0|0.45|0.98|||Fisher Exact|||||0.98|0.45|0.047
71720152|NCT00910910|142956133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.826|TWO_SIDED|90.0|0.58|1.52|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.52|0.58|0.826
71720153|NCT00910910|142956134|SUPERIORITY||Cox Proportional Hazard|0.71||||0.149|TWO_SIDED|90.0|0.48|1.05|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.05|0.48|0.149
71768952|NCT00545129|143038258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.59||0.237|TWO_SIDED|95.0|-1.95|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as covariate and study site as random effect. LS mean difference and corresponding 95% CI were estimated from ANCOVA model.||0.51|-1.95|0.237
71768953|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
71829626|NCT03622580|143163404|OTHER||Difference in CMH Weighted Percentage|-3.2|||||TWO_SIDED|95.0|-10.2|3.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||3.8|-10.2|
71829627|NCT03622580|143163404|OTHER||Difference in CMH Weighted Percentage|2.4|||||TWO_SIDED|95.0|-4.3|9.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.2|-4.3|
71829628|NCT03622580|143163404|OTHER||Difference in CMH Weighted Percentage|-4.7|||||TWO_SIDED|95.0|-12.6|3.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.1|-12.6|
71829629|NCT03622580|143163404|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.9|6.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||6.4|-8.9|
71829630|NCT03622580|143163407|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-1.8|2.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.9|-1.8|
71720154|NCT00910910|142956137|SUPERIORITY||Cox Proportional Hazard|1.03||||0.883|TWO_SIDED|90.0|0.73|1.46|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|||1.46|0.73|0.883
71720155|NCT00910910|142956138|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||0.709|TWO_SIDED|90.0|0.83|1.34|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups|||1.34|0.83|0.709
71720156|NCT03024112|142956150|OTHER|||||||0.68|||||||t-test, 1 sided|||||||0.680
71720157|NCT01771991|142956170|SUPERIORITY||sum of scores|453.0|STANDARD_DEVIATION|39.6||0.57|TWO_SIDED||||||Wilcoxon Rank-Sum||Standard Deviation under the Null hypothesis for each group.|||||0.57
71720158|NCT01771991|142956171|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|1.5||0.65|TWO_SIDED|95.0|-0.6|0.95|||t-test, 2 sided|||Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.||0.95|-0.60|0.65
71768954|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
71768955|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
71829631|NCT03622580|143163407|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.2|2.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.3|-2.2|
71720159|NCT01771991|142956172|SUPERIORITY||Mean Difference (Final Values)|2.63|STANDARD_DEVIATION|17.79||0.57|TWO_SIDED|95.0|-6.65|11.91|||t-test, 2 sided|||Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.||11.91|-6.65|0.57
71720160|NCT01399229|142956186|NON_INFERIORITY_OR_EQUIVALENCE|"Agreement between SureCALL® and Tocodynamometer Contraction Peak Times~Null hypothesis: The mean peak difference between RMS and TOCO is equal to 0. Alternative hypothesis: The mean peak difference is not equal to 0."|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|1.4086||0.4901|TWO_SIDED|95.0|-28.74|30.72|||Mixed Models Analysis|||||30.72|-28.74|0.4901
71720161|NCT01434654|142956217|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for arm\*time interaction fixed effect.|Mixed Models Analysis|49 datapoints included from baseline, 6 months, and 12 months visits (low CNS penetrance n=14; high CNS penetrance n=35)||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.99
71720162|NCT01434654|142956218|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in NAA/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
71720163|NCT01434654|142956218|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANOVA|||Change in Cr/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.44
71720164|NCT01434654|142956218|SUPERIORITY_OR_OTHER|||||||0.86|||||||ANOVA|||Change in Cho/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.86
71720165|NCT01434654|142956218|SUPERIORITY_OR_OTHER|||||||0.98|||||||ANOVA|||Change in mIo/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.98
71720166|NCT01434654|142956219|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.16
71720167|NCT01434654|142956219|SUPERIORITY_OR_OTHER|||||||0.09|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.09
71720168|NCT01434654|142956219|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.06
71720169|NCT01434654|142956219|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.68
71720170|NCT01434654|142956219|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.58
71720171|NCT00703963|142956223|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.20
71720172|NCT00703963|142956224|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||0.05
71768956|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.601|TWO_SIDED|95.0|0.44|4.53|||Fisher Exact|||Week 4 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.53|0.44|0.601
71768957|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
71768958|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
71768959|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.596|TWO_SIDED|95.0|0.43|4.66|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.66|0.43|0.596
71768960|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.552|TWO_SIDED|95.0|0.39|6.24|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.24|0.39|0.552
71768961|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
71768962|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
71829632|NCT03622580|143163407|OTHER||Difference in CMH Weighted Percentage|0.8|||||TWO_SIDED|95.0|-2.0|3.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||3.6|-2.0|
71720173|NCT00703963|142956225|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p \< 0.05.||||<0.001
71720174|NCT00402324|142956228|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||<0.001
71720175|NCT00402324|142956229|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline\*Visit Therapy\*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses-the probability of simultaneously rejecting both co-primary null hypotheses-for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.||||0.022
71720176|NCT00402324|142956230|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Fisher Exact|||||||0.100
71720177|NCT00402324|142956231|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
71720178|NCT00402324|142956232|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= TRT + Pooled Investigator + Baseline.||||||0.056
71720179|NCT00402324|142956234|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value for Total Cholesterol Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.657
71720180|NCT00402324|142956234|SUPERIORITY_OR_OTHER|||||||0.924||95.0||||P-value for Low Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.924
71720181|NCT00402324|142956234|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for High Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.122
71720182|NCT00402324|142956235|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||P-value for Fasting Triglycerides Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.293
71720183|NCT00402324|142956236|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Fasting Blood Glucose Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.007
71720184|NCT00402324|142956237|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin Total Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator||||||0.046
71720185|NCT00402324|142956238|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
71720186|NCT00402324|142956239|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline||||||<0.001
71720187|NCT00402324|142956240|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71720188|NCT01277822|142956241|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin was 3 mmHg as Korean Food and Drug Administration (KFDA) guidance.|Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|7.7||0.1339|TWO_SIDED|95.0|-3.0|0.4|||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||0.4|-3.0|0.1339
71720189|NCT01277822|142956242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4478||||||No imputation for missing data was performed|t-test, 2 sided|||||||0.4478
71720190|NCT01277822|142956243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0717|||||||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis||||||0.0717
71720191|NCT01277822|142956244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8736|||||||t-test, 2 sided|No imputation for missing data was performed||||||0.8736
71720192|NCT01277822|142956245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
71720193|NCT01277822|142956246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2508||||||No imputation for missing data was performed|Chi-squared|||||||0.2508
71720194|NCT01277822|142956247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6646|||||||Chi-squared|||||||0.6646
71720195|NCT01277822|142956248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7911||||||Left ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.7911
71720196|NCT01277822|142956248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5933||||||Right ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided|||||||0.5933
71720197|NCT00997984|142956264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
71720198|NCT00997984|142956264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
71720199|NCT00997984|142956264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p\<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.||||<0.001
71720200|NCT00997984|142956265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71720201|NCT00997984|142956265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71720202|NCT00997984|142956265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71720203|NCT00997984|142956266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71720204|NCT00997984|142956266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71720205|NCT00997984|142956266|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||<0.001
71720206|NCT00997984|142956267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.099
71720207|NCT00997984|142956267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.596||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.596
71720208|NCT00997984|142956267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.023
71768963|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.73||||0.029|TWO_SIDED|95.0|1.04|14.32|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||14.32|1.04|0.029
71768964|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63||||0.143|TWO_SIDED|95.0|0.67|11.36|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||11.36|0.67|0.143
71768965|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
71768966|NCT00545129|143038259|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
71829633|NCT03622580|143163407|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.6|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-2.6|
71829634|NCT03622580|143163416|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
71720209|NCT00997984|142956269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71720210|NCT00997984|142956269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71720211|NCT00997984|142956269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71720212|NCT00997984|142956270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.712
71720213|NCT00997984|142956270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.531||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.531
71720214|NCT00997984|142956270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.226
71768967|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||1|TWO_SIDED|95.0|0.1|4.94|||Fisher Exact|||Week 1 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.94|0.10|1.000
71768968|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||1|TWO_SIDED|95.0|0.23|3.32|||Fisher Exact|||Week 2 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.32|0.23|1.000
71768969|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||1|TWO_SIDED|95.0|0.05|6.35|||Fisher Exact|||Week 2 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.35|0.05|1.000
71720215|NCT00997984|142956271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.859
71720216|NCT00997984|142956271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.527
71720217|NCT00997984|142956271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||95.0||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel|||||||0.739
71720218|NCT00997984|142956272|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||<0.001
71720219|NCT00997984|142956272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.004
71720220|NCT00997984|142956272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||No formal adjustment for multiplicity was done.|ANCOVA|||||||0.001
71768970|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.795|TWO_SIDED|95.0|0.38|3.88|||Fisher Exact|||Week 4 (\>=30%) reduction: odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.88|0.38|0.795
71768971|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.36|TWO_SIDED|95.0|0.46|8.51|||Fisher Exact|||Week 4 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.51|0.46|0.360
71768972|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||1|TWO_SIDED|95.0|0.01|10.24|||Fisher Exact|||Week 4 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||10.24|0.01|1.000
71768973|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||1|TWO_SIDED|95.0|0.33|3.39|||Fisher Exact|||Week 6 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.39|0.33|1.000
71768974|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.771|TWO_SIDED|95.0|0.33|4.83|||Fisher Exact|||Week 6 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||4.83|0.33|0.771
71768975|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.612|TWO_SIDED|95.0|0.1|131.03|||Fisher Exact|||Week 6 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||131.03|0.10|0.612
71768976|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|19.66|||Fisher Exact|||Week 6 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||19.66|0.00|1.000
71829635|NCT03622580|143163416|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.1|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.1|
71829636|NCT03622580|143163416|OTHER||Difference in CMH Weighted Percentage|-0.6|||||TWO_SIDED|95.0|-1.9|0.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.6|-1.9|
71887453|NCT01337973|143295797|SUPERIORITY||Coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.62|1.47||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.52|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.47|0.62|<0.001
71720221|NCT03711370|142956303|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by bottle type interactions on infant intake during post-test feeding observations.||||||0.76||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.76
71768977|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.187|TWO_SIDED|95.0|0.66|7.3|||Fisher Exact|||Week 8 (\>=30%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.30|0.66|0.187
71768978|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.73||||0.399|TWO_SIDED|95.0|0.48|6.43|||Fisher Exact|||Week 8 (\>=50%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||6.43|0.48|0.399
71768979|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.07|15.25|||Fisher Exact|||Week 8 (\>=70%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||15.25|0.07|1.000
71768980|NCT00545129|143038260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.0||||0.492|TWO_SIDED|95.0|0.0|3.57|||Fisher Exact|||Week 8 (\>=90%) reduction: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||3.57|0.00|0.492
71887454|NCT01337973|143295797|SUPERIORITY||coefficient estimate|0.49|||<|0.01|TWO_SIDED|95.0|0.18|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.98|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||1.32|0.18|<0.01
71768981|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.68||0.188|TWO_SIDED|95.0|0.77|3.73|||Negative binomial regression|||Week 1: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.73|0.77|0.188
71768982|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|0.85||0.207|TWO_SIDED|95.0|0.72|4.54|||Negative binomial regression|||Week 2: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.54|0.72|0.207
71768983|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.71|STANDARD_ERROR_OF_MEAN|0.92||0.317|TWO_SIDED|95.0|0.6|4.93|||Negative binomial regression|||Week 3: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||4.93|0.60|0.317
71768984|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.7||0.554|TWO_SIDED|95.0|0.5|3.71|||Negative binomial regression|||Week 4: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||3.71|0.50|0.554
71768985|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.35||0.581|TWO_SIDED|95.0|0.32|1.89|||Negative binomial regression|||Week 5: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.89|0.32|0.581
71829637|NCT03622580|143163416|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.5|-1.5|
71829638|NCT03622580|143163417|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.2|-0.4|
71829639|NCT03622580|143163417|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
71829640|NCT03622580|143163417|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
71887455|NCT01337973|143295797|SUPERIORITY||coefficient estimate|0.85|||<|0.05|TWO_SIDED|95.0|0.4|1.8||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.13|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||1.8|0.4|<0.05
71887456|NCT01337973|143295797|SUPERIORITY||coefficient estimate|0.84|||<|0.05|TWO_SIDED|95.0|0.54|1.32||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.48|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.32|0.54|<0.05
71887457|NCT01337973|143295797|SUPERIORITY||coefficient estimate|1.15|||<|0.001|TWO_SIDED|95.0|0.78|1.71||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.94|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||1.71|0.78|<0.001
71720222|NCT03711370|142956304|OTHER|Repeated measures ANOVA was used to model between-subject effects of group (Clear versus Opaque), within-subjects effects of use of clear versus opaque bottles during the feeding observations, and potential group by-bottle type interactions on maternal sensitivity during post-test feeding observations.||||||0.64||||||Statistical significance was defined as p \< 0.05.|Mixed Models Analysis|Models controlled for pre-test values, infant sex and age, time since last feeding, and whether the assessment was in-person or remote.||||||0.64
71720223|NCT03711370|142956305|OTHER|General linear models were used to compare post-test weight-for-length z-scores (WLZ).||||||0.02||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|These models controlled for baseline values (i.e., baseline WLZ), infant sex and age, and whether the assessment was in-person or remote.||||||0.02
71720224|NCT03711370|142956306|OTHER|General linear models were used to compare post-test waist circumference for the Clear versus Opaque groups.||||||0.07||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e., waist circumference), infant sex and age, and whether the assessment was in-person or remote.||||||0.07
71720225|NCT03711370|142956307|OTHER|General linear models were used to compare post-test triceps skinfold z-scores for the Clear versus Opaque groups.||||||0.7||||||Statistical significance was defined as p \< 0.05.|Regression, Linear|Model controlled for baseline values (i.e.,triceps skinfolds z-scores), infant sex and age, and whether the assessment was in-person or remote.||||||0.70
71720226|NCT01158820|142956318|OTHER|No data available for power analysis|Mean Difference (Net)|0.028|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71720227|NCT01158820|142956319|SUPERIORITY||Mean Difference (Final Values)|43.75|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are µg|See reference power analysis||||<0.01
71720228|NCT01158820|142956320|SUPERIORITY||Median Difference (Final Values)|1.75||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||units are mg|See reference for power analysis||||0.01
71720229|NCT01763333|142956337|SUPERIORITY_OR_OTHER||Slope|0.8728|||||TWO_SIDED|95.0|0.6942|1.0513|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0513|0.6942|
71720230|NCT01763333|142956337|SUPERIORITY_OR_OTHER||Slope|0.9341|||||TWO_SIDED|95.0|0.8277|1.0405|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0405|0.8277|
71720231|NCT01763333|142956337|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|112.74|||||TWO_SIDED|90.0|95.579|132.993|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||132.993|95.579|
71720232|NCT01763333|142956337|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|52.66|||||TWO_SIDED|90.0|40.488|68.499|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||68.499|40.488|
71720233|NCT01763333|142956337|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|239.63|||||TWO_SIDED|90.0|197.445|290.83|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||290.830|197.445|
71768986|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.61|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.26|1.43|||Negative binomial regression|||Week 6: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.43|0.26|0.252
71720234|NCT01763333|142956337|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|105.47|||||TWO_SIDED|90.0|85.427|130.208|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||130.208|85.427|
71720235|NCT01763333|142956339|SUPERIORITY_OR_OTHER||Slope|0.8341|||||TWO_SIDED|95.0|0.6485|1.0198|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0198|0.6485|
71720236|NCT01763333|142956339|SUPERIORITY_OR_OTHER||Slope|0.9149|||||TWO_SIDED|95.0|0.8059|1.0239|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0239|0.8059|
71720237|NCT01763333|142956339|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean Ratio|86.61|||||TWO_SIDED|90.0|76.529|98.029|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.029|76.529|
71720238|NCT01763333|142956339|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|74.44|||||TWO_SIDED|90.0|66.322|83.562|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.562|66.322|
71720239|NCT01763333|142956339|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.25|||||TWO_SIDED|90.0|119.708|157.353|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.||157.353|119.708|
71720240|NCT01763333|142956339|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.48|||||TWO_SIDED|90.0|111.462|121.724|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||121.724|111.462|
71720241|NCT01763333|142956340|SUPERIORITY_OR_OTHER||Slope|0.8428|||||TWO_SIDED|95.0|0.658|1.0275|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0- tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0275|0.6580|
71768987|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.31||0.365|TWO_SIDED|95.0|0.26|1.64|||Negative binomial regression|||Week 7: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.64|0.26|0.365
71720242|NCT01763333|142956340|SUPERIORITY_OR_OTHER||Slope|0.9307|||||TWO_SIDED|95.0|0.8187|1.0426|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.|This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.||1.0426|0.8187|
71720243|NCT01763333|142956340|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean Ratio|86.16|||||TWO_SIDED|90.0|75.735|98.027|||||Adjusted geometric mean (gMean) ratio.|Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.||98.027|75.735|
71720244|NCT01763333|142956340|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean ratio|74.42|||||TWO_SIDED|90.0|65.979|83.941|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.||83.941|65.979|
71720245|NCT01763333|142956340|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.2|||||TWO_SIDED|90.0|119.611|157.374|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.||157.374|119.611|
71720246|NCT01763333|142956340|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.83|||||TWO_SIDED|90.0|111.814|122.079|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.||122.079|111.814|
71768988|NCT00545129|143038262|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.25||0.212|TWO_SIDED|95.0|0.25|1.36|||Negative binomial regression|||Week 8: Negative binomial regression model with model terms for treatment as a main effect. P-value was based on negative binomial regression model from pairwise comparisons. LS mean difference and corresponding 95% CI were estimated from the corresponding negative binomial regression model.||1.36|0.25|0.212
71768989|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.215|TWO_SIDED|95.0|-0.13|0.55|||ANCOVA|||Change at Week 2 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.13|0.215
71768990|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.947|TWO_SIDED|95.0|-0.45|0.42|||ANCOVA|||Change at Week 4 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.42|-0.45|0.947
71768991|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.341|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Change at Week 6 (Fatigue MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.20|-0.56|0.341
71768992|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.24||0.18|TWO_SIDED|95.0|-0.83|0.17|||ANCOVA|||Change at Week 2 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.17|-0.83|0.180
71768993|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.509|TWO_SIDED|95.0|-0.43|0.84|||ANCOVA|||Change at Week 4 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.84|-0.43|0.509
71768994|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.767|TWO_SIDED|95.0|-0.62|0.82|||ANCOVA|||Change at Week 6 (Drowsiness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.82|-0.62|0.767
71768995|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.25||0.108|TWO_SIDED|95.0|-0.11|0.95|||ANCOVA|||Change at Week 2 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.95|-0.11|0.108
71829641|NCT03622580|143163417|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
71829642|NCT03622580|143163424|OTHER||Adjusted mean difference|-36.2|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-47.8|-24.7||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-24.7|-47.8|
71829643|NCT03622580|143163424|OTHER||Adjusted mean difference|-26.2|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-37.7|-14.7||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.7|-37.7|
71720247|NCT00005947|142956359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.052||95.0|0.99|2.11|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[placebo/sipuleucel-T\].|||2.11|0.99|0.052
71720248|NCT00005947|142956359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.052|TWO_SIDED|95.0|0.47|1.01|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable \[sipuleucel-T/placebo\]|||1.01|0.47|0.052
71887458|NCT01337973|143295797|SUPERIORITY||coefficient estimate|0.61|||<|0.05|TWO_SIDED|95.0|0.17|2.16||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.56|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||2.16|0.17|<0.05
71887459|NCT01337973|143295797|SUPERIORITY||coefficient estimate|1.18|||<|0.01|TWO_SIDED|95.0|0.57|2.44||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.86|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||2.44|0.57|<0.01
71720249|NCT00005947|142956360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.71||||0.01||95.0|1.13|2.58|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[placebo/sipuleucel-T\].|ITT Population - all randomized participants||2.58|1.13|0.010
71720250|NCT00005947|142956360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.586||||0.01|TWO_SIDED|95.0|0.388|0.884|||Log Rank||Cox proportional hazards model with treatment as the independent variable \[sipuleucel-T/placebo\]|ITT Population - all randomized participants.||0.884|0.388|0.010
71720251|NCT00556439|142956384|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.049||||||The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.049
71720252|NCT00556439|142956384|OTHER|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.853||||||The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||0.853
71720253|NCT02931838|142956391|SUPERIORITY|||||||0.4873||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.4873
71720254|NCT02931838|142956391|SUPERIORITY|||||||0.0003||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||0.0003
71720255|NCT02931838|142956391|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
71720256|NCT02931838|142956391|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||< 0.0001
71720257|NCT02931838|142956391|SUPERIORITY||||||<|0.0001||||||Nominal p-value|Chi-squared|P-value is from the Fishers Exact if at least one cell count is \<5. Otherwise, p-value is from the Chi-Square test.||||||<0.0001
71720258|NCT03419897|142956500|SUPERIORITY|||||||0.0001|||||||Binomial exact test|||Tislelizumab compared with historical ORR rate of 7%||||0.0001
71720259|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior frontal gyrus||||<0.05
71720260|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Desire to void: L superior temporal gyrus||||<0.05
71720261|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior temporal gyrus||||<0.05
71720262|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle temporal gyrus||||<0.05
71720263|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle temporal gyrus||||<0.05
71720264|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior parietal lobule||||<0.05
71720265|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R inferior parietal lobule||||<0.05
71720266|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R paracentral lobule||||<0.05
71720267|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R superior parietal lobule||||<0.05
71720268|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supplementary motor area||||<0.05
71720269|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L postcentral gyrus||||<0.05
71720270|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R postcentral gyrus||||<0.05
71720271|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L angular gyrus||||<0.05
71720272|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R supramarginal gyrus||||<0.05
71720273|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior medial gyrus||||<0.05
71720274|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L inferior occipital gyrus||||<0.05
71720275|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle cingulate cortex||||<0.05
71720276|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R middle cingulate cortex||||<0.05
71720277|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R posterior cingulate cortex||||<0.05
71720278|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L thalamus||||<0.05
71720279|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R thalamus||||<0.05
71720280|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precuneus||||<0.05
71720281|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precuneus||||<0.05
71720282|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L caudate nucleus||||<0.05
71720283|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire void: L hippocampus||||<0.05
71657071|NCT02944383|142831653|SUPERIORITY||Median Difference (Net)|-19.31||||0.0156|TWO_SIDED|95.0|-39.06|-1.49||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.49|-39.06|0.0156
71720284|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L hippocampus||||<0.05
71720285|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L putamen||||<0.05
71720286|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L precentral gyrus||||<0.05
71720287|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R precentral gyrus||||<0.05
71768996|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.37||0.28|TWO_SIDED|95.0|-1.26|0.41|||ANCOVA|||Change at Week 4 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.41|-1.26|0.280
71768997|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.57||0.747|TWO_SIDED|95.0|-1.53|1.15|||ANCOVA|||Change at Week 6 (Inability to Concentrate MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.15|-1.53|0.747
71768998|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.991|TWO_SIDED|95.0|-0.87|0.88|||ANCOVA|||Change at Week 2 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.88|-0.87|0.991
71768999|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.27||0.335|TWO_SIDED|95.0|-0.41|0.99|||ANCOVA|||Change at Week 4 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.99|-0.41|0.335
71720288|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L insula lobe||||<0.05
71720289|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L superior frontal gyrus||||<0.05
71720290|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: L middle frontal gyrus||||<0.05
71720291|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R cerebellum||||<0.05
71720292|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Strong desire to void: R fusiform gyrus||||<0.05
71720293|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L postcentral gyrus||||<0.05
71720294|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R postcentral gyrus||||<0.05
71720295|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precentral gyrus||||<0.05
71720296|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precentral gyrus||||<0.05
71720297|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior temporal gyrus||||<0.05
71720298|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior temporal gyrus||||<0.05
71720299|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle temporal gyrus||||<0.05
71720300|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle temporal gyrus||||<0.05
71720301|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior temporal gyrus||||<0.05
71720302|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supramarginal gyrus||||<0.05
71720303|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R supramarginal gyrus||||<0.05
71720304|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: L inferior occipital gyrus||||<0.05
71720305|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior occipital gyrus||||<0.05
71720306|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding Initiation: R middle occipital gyrus||||<0.05
71720307|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Orbitalis)||||<0.05
71720308|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Triangularis)||||<0.05
71720309|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L inferior frontal gyrus (p. Opercularis)||||<0.05
71720310|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Orbitalis)||||<0.05
71720311|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior frontal gyrus (p. Triangularis)||||<0.05
71720312|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L cerebellum||||<0.05
71720313|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rectal gyrus||||<0.05
71720314|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rectal gyrus||||<0.05
71720315|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior medial gyrus||||<0.05
71720316|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior medial gyrus||||<0.05
71720317|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior frontal gyrus||||<0.05
71720318|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior frontal gyrus||||<0.05
71720319|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle frontal gyrus||||<0.05
71720320|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle frontal gyrus||||<0.05
71720321|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L supplementary motor area (SMA)||||<0.05
71720322|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R SMA||||<0.05
71887460|NCT01337973|143295797|SUPERIORITY||coefficient estimate|0.95|||<|0.001|TWO_SIDED|95.0|0.61|1.48||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.51|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||1.48|0.61|<0.001
71887461|NCT01337973|143295797|SUPERIORITY||||||<|0.001||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.65||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"||||<0.001
71720323|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L paracentral lobule||||<0.05
71720324|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R paracentral lobule||||<0.05
71720325|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R superior parietal lobule||||<0.05
71720326|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R inferior parietal lobule||||<0.05
71720327|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L superior orbital gyrus||||<0.05
71720328|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle orbital gyrus||||<0.05
71720329|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle orbital gyrus||||<0.05
71720330|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R calcarine gyrus||||<0.05
71720331|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L calcarine gyrus||||<0.05
71887462|NCT01337973|143295797|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.45||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"||||>0.05
71720332|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L anterior cingulate cortex||||<0.05
71720333|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L middle cingulate cortex||||<0.05
71720334|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R middle cingulate cortex||||<0.05
71769000|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.7||0.159|TWO_SIDED|95.0|-4.57|1.48|||ANCOVA|||Change at Week 6 (Nausea MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.48|-4.57|0.159
71769001|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23||0.136|TWO_SIDED|95.0|-0.16|0.94|||ANCOVA|||Change at Week 2 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.94|-0.16|0.136
71769002|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.37||0.186|TWO_SIDED|95.0|-3.46|5.9|||ANCOVA|||Change at Week 6 (Dizziness MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||5.90|-3.46|0.186
71769003|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.48||0.292|TWO_SIDED|95.0|-1.52|0.49|||ANCOVA|||Change at Week 2 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.49|-1.52|0.292
71769004|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.38||0.225|TWO_SIDED|95.0|-0.34|1.3|||ANCOVA|||Change at Week 4 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.30|-0.34|0.225
71887463|NCT01337973|143295797|SUPERIORITY||||||>|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.5||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"||||>0.05
71720335|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R angular gyrus||||<0.05
71720336|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L thalamus||||<0.05
71720337|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R thalamus||||<0.05
71720338|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L precuneus||||<0.05
71720339|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R precuneus||||<0.05
71720340|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R caudate nucleus||||<0.05
71720341|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L putamen||||<0.05
71720342|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L amygdala||||<0.05
71720343|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R insula lobe||||<0.05
71720344|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L rolandic operculum||||<0.05
71720345|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: L hippocampus||||<0.05
71720346|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R hippocampus||||<0.05
71720347|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R fusiform gyrus||||<0.05
71720348|NCT03574610|142956517|OTHER||||||<|0.05|||||||Student's t-test|||Voiding initiation: R rolandic operculum||||<0.05
71720349|NCT03574610|142956518|OTHER|||||||0.45||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Voided volume - baseline vs post-treatment||||0.45
71720350|NCT03574610|142956518|OTHER|||||||0.39||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Voided volume - baseline vs 4 month follow-up||||0.39
71887464|NCT01337973|143295797|SUPERIORITY||||||<|0.05||||||The threshold for significance was p\<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.58||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"||||<0.05
71887465|NCT00254566|143295804|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-0.9||||||95.0|-5.8|3.9|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval|95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.9|-5.8|
71887466|NCT00254566|143295805|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in the percentage of participants with Cure and the 95% CI|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.||3.4|-8.5|
71887467|NCT00254566|143295806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.||3.4|-8.5|
71887468|NCT00254566|143295807|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||||95.0|-4.5|3.3|||||Risk difference is the difference in eradication rates of pathogens by treatment|||3.3|-4.5|
71887469|NCT00254566|143295808|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.33||||0.159||95.0|0.9|2.0||p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate|Regression, Cox|||Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because \<50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups' recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).||2.0|0.9|0.159
71657072|NCT02944383|142831653|SUPERIORITY||Median Difference (Net)|-5.98||||0.3456|TWO_SIDED|95.0|-28.51|17.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||17.26|-28.51|0.3456
71720351|NCT03574610|142956518|OTHER|||||||0.014||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||PVR - baseline vs post-treatment||||0.014
71720352|NCT03574610|142956518|OTHER|||||||0.66||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||PVR - baseline vs 4 month follow-up||||0.66
71720353|NCT03574610|142956518|OTHER|||||||0.31||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Bladder capacity - baseline vs post-treatment||||0.31
71720354|NCT03574610|142956518|OTHER|||||||0.001||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Bladder capacity - baseline vs 4 month follow-up||||0.001
71720355|NCT03574610|142956519|OTHER|||||||0.004||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||% PVR/BC - baseline vs post-treatment||||0.004
71720356|NCT03574610|142956519|OTHER|||||||0.038||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||%PVR/BC - baseline vs 4 month follow-up||||0.038
71720357|NCT03574610|142956520|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Qmax - baseline vs post-treatment||||0.19
71720358|NCT03574610|142956520|OTHER|||||||0.91||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Max - baseline vs 4 month follow-up||||0.91
71769005|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.36||0.517|TWO_SIDED|95.0|-0.58|1.07|||ANCOVA|||Change at Week 6 (Constipation MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.07|-0.58|0.517
71887470|NCT00254566|143295809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.57||95.0|-0.21|0.12|||ANCOVA|Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates||||0.12|-0.21|0.57
71887471|NCT00254566|143295809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.82||95.0|-0.13|0.1|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.10|-0.13|0.82
71887472|NCT00254566|143295810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.81||95.0|-0.21|0.17|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.17|-0.21|0.81
71887473|NCT00254566|143295810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.87||95.0|-0.12|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.12|0.87
71887474|NCT00254566|143295811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.385||95.0|-0.27|0.1|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.10|-0.27|0.385
71720359|NCT03574610|142956521|OTHER|||||||0.13||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||Liverpool nomogram percentile - baseline vs post-treatment||||0.13
71720360|NCT03574610|142956521|OTHER|||||||0.26||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||Liverpool nomogram percentile - baseline vs 4 month follow-up||||0.26
71720361|NCT03574610|142956522|OTHER|||||||0.4||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q1 - baseline vs post-treatment||||0.40
71720362|NCT03574610|142956522|OTHER|||||||0.086||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q1 - baseline vs 4 month follow-up||||0.086
71720363|NCT03574610|142956522|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test.||UDI-6 Q2 - baseline vs post-treatment||||0.54
71720364|NCT03574610|142956522|OTHER|||||||0.19||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 Q2 - baseline vs 4 month follow-up||||0.19
71720365|NCT03574610|142956522|OTHER|||||||0.04||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||UDI-6 Q5 - baseline vs post-treatment||||0.04
71720366|NCT03574610|142956522|OTHER|||||||0.026||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||UDI-6 5 - baseline vs 4 month follow-up||||0.026
71720367|NCT03574610|142956523|OTHER|||||||0.044||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q3 - baseline vs post-treatment||||0.044
71720368|NCT03574610|142956523|OTHER|||||||0.017||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q3 - baseline vs 4 month follow-up||||0.017
71720369|NCT03574610|142956523|OTHER|||||||0.54||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q5 - baseline vs post-treatment||||0.54
71720370|NCT03574610|142956523|OTHER|||||||0.503||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q5 - baseline vs 4 month follow-up||||0.503
71769006|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-2.48|2.48|||ANCOVA|||Change at Week 2 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||2.48|-2.48|1.000
71769007|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|95.0|-1.01|-0.99|||ANCOVA|||Change at Week 4 (Itching MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.99|-1.01|<0.001
71769008|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.43||0.362|TWO_SIDED|95.0|-0.75|1.63|||ANCOVA|||Change at Week 2 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||1.63|-0.75|0.362
71720371|NCT03574610|142956523|OTHER|||||||0.023||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q7 - baseline vs post-treatment||||0.023
71720372|NCT03574610|142956523|OTHER|||||||0.049||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q7 - baseline vs 4 month follow-up||||0.049
71720373|NCT03574610|142956523|OTHER|||||||0.089||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||AUASS Q8 - baseline vs post-treatment||||0.089
71720374|NCT03574610|142956523|OTHER|||||||0.161||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||AUASS Q8 - baseline vs 4 month follow-up||||0.161
71720375|NCT03574610|142956524|OTHER|||||||0.01||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Incontinence) - baseline vs post-treatment||||0.010
71720376|NCT03574610|142956524|OTHER|||||||0.41||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Incontinence) - baseline vs 4 month follow-up||||0.41
71720377|NCT03574610|142956524|OTHER|||||||0.32||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Storage and Voiding) - baseline vs post-treatment||||0.32
71720378|NCT03574610|142956524|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Storage and Voiding) - baseline vs 4 month follow-up||||0.02
71720379|NCT03574610|142956524|OTHER|||||||0.34||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test||NBSS (Consequences) - baseline vs post-treatment||||0.34
71769009|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|4.08||1|TWO_SIDED|95.0|-51.87|51.87|||ANCOVA|||Change at Week 4 (Difficulty with Urination MDA): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||51.87|-51.87|1.000
71720380|NCT03574610|142956524|OTHER|||||||0.61||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (Consequences) - baseline vs 4 month follow-up||||0.61
71720381|NCT03574610|142956524|OTHER|||||||0.02||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs post-treatment||||0.02
71720382|NCT03574610|142956524|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|Paired t-test. (Only used the 8 participants that had data for baseline and 4 month follow-up for statistical calculations)||NBSS (QoL) - baseline vs 4 month follow-up||||0.07
71769010|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.1||0.031|TWO_SIDED|95.0|-3.3|-0.76|||ANCOVA|||Change at Week 4 (Retching/Vomiting MDR): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||-0.76|-3.30|0.031
71769011|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.15||0.886|TWO_SIDED|95.0|-0.28|0.32|||ANCOVA|||Change at Week 2 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.32|-0.28|0.886
71769012|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.66|TWO_SIDED|95.0|-0.52|0.33|||ANCOVA|||Change at Week 4 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.33|-0.52|0.660
71769013|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.238|TWO_SIDED|95.0|-0.54|0.14|||ANCOVA|||Change at Week 6 (Frequency Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.14|-0.54|0.238
71769014|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.14||0.36|TWO_SIDED|95.0|-0.42|0.16|||ANCOVA|||Change at Week 2 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.16|-0.42|0.360
71769015|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.278|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Change at Week 4 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.54|-0.16|0.278
71769016|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.809|TWO_SIDED|95.0|-0.34|0.27|||ANCOVA|||Change at Week 6 (Severity Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.27|-0.34|0.809
71769017|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.18||0.944|TWO_SIDED|95.0|-0.35|0.38|||ANCOVA|||Change at Week 2 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.38|-0.35|0.944
71769018|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.892|TWO_SIDED|95.0|-0.48|0.55|||ANCOVA|||Change at Week 4 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.55|-0.48|0.892
71769019|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.884|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Change at Week 6 (Bother Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.39|0.884
71769020|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.919|TWO_SIDED|95.0|-0.26|0.28|||ANCOVA|||Change at Week 2 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.28|-0.26|0.919
71887475|NCT00254566|143295811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.56||95.0|-0.17|0.09|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.09|-0.17|0.56
71887476|NCT00254566|143295812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.62||95.0|-0.26|0.16|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates||||0.16|-0.26|0.62
71887477|NCT00254566|143295812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8||95.0|-0.18|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate||||0.14|-0.18|0.80
71769021|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.19||0.752|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||Change at Week 4 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.45|-0.33|0.752
71769022|NCT00545129|143038263|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.715|TWO_SIDED|95.0|-0.34|0.24|||ANCOVA|||Change at Week 6 (MDA Composite Score): LS mean difference and corresponding 95% CI were estimated from the corresponding repeated measures ANCOVA model.||0.24|-0.34|0.715
71769023|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.47||0.666|TWO_SIDED|95.0|-0.77|1.18|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.77|0.666
71769024|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.49||0.745|TWO_SIDED|95.0|-0.86|1.18|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.18|-0.86|0.745
71769025|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.48||0.749|TWO_SIDED|95.0|-1.14|0.83|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.83|-1.14|0.749
71887478|NCT00356031|143295837|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
71887479|NCT00356031|143295838|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<.05
71887480|NCT02167945|143295843|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71720383|NCT01032954|142956525|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM= GENERAL LINEAR MODELS WITH REPEATED|||||||<0.05
71720384|NCT01032954|142956526|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||P-value threshold for significance: \<0.05|GLM|||||||<0.05
71887481|NCT02167945|143295843|SUPERIORITY||Cox Proportional Hazard Ratio|0.126|||<|0.001|TWO_SIDED|95.0|0.044|0.358|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.358|0.044|<0.001
71720385|NCT03759639|142956533|SUPERIORITY||Hodges-Lehmann Estimator|1.0||||0.029|TWO_SIDED|90.0|0.25|1.75|||1-sided Wilcoxon signed-rank test|||||1.75|0.25|0.029
71720386|NCT03759639|142956535|SUPERIORITY||Hodges-Lehmann Estimator|0.13||||0.318|TWO_SIDED|90.0|-0.25|0.5|||1-sided Wilcoxon signed-rank test|||||0.50|-0.25|0.318
71720387|NCT03759639|142956538|SUPERIORITY||Hodges-Lehmann Estimator|0.0854||||0.084|TWO_SIDED|90.0|-0.0123|0.1777|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||0.1777|-0.0123|0.084
71720388|NCT03759639|142956538|SUPERIORITY||Hodges-Lehmann Estimator|-0.0399||||0.315|TWO_SIDED|90.0|-0.1269|0.1031|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.1031|-0.1269|0.315
71720389|NCT03759639|142956539|SUPERIORITY||Hodges-Lehmann Estimator|-1.25||||0.001|TWO_SIDED|90.0|-1.75|-0.5|||1-sided Wilcoxon signed-rank test|||Treatment With IB1001||-0.50|-1.75|0.001
71720390|NCT03759639|142956539|SUPERIORITY||Hodges-Lehmann Estimator|1.25||||0.002|TWO_SIDED|90.0|0.5|2.0|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||2.00|0.50|0.002
71720391|NCT03759639|142956541|SUPERIORITY||Hodges-Lehmann Estimator|0.0||||0.121|TWO_SIDED|90.0|-0.021|0.0|||1-sided Wilcoxon signed-rank test|||Treatment with IB1001||0.000|-0.021|0.121
71720392|NCT03759639|142956541|SUPERIORITY||Hodges-Lehmann Estimator|0.021||||0.056|TWO_SIDED|90.0|0.0|0.042|||1-sided Wilcoxon signed-rank test|||Post-Treatment Washout||0.042|0.000|0.056
71769026|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.5||0.794|TWO_SIDED|95.0|-1.16|0.9|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.90|-1.16|0.794
71887482|NCT02167945|143295844|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71720393|NCT03759639|142956542|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||<0.001
71720394|NCT03759639|142956542|SUPERIORITY||Mean Difference (Net)|4.5||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.006
71720395|NCT03759639|142956543|SUPERIORITY||Mean Difference (Net)|3.4||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.005
71720396|NCT03759639|142956543|SUPERIORITY||Mean Difference (Net)|4.4||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment With IB1001||||0.038
71720397|NCT03759639|142956544|SUPERIORITY||Mean Difference (Net)|3.3||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Treatment with IB1001||||0.003
71720398|NCT03759639|142956544|SUPERIORITY||Mean Difference (Net)|4.4||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Post-Treatment Washout||||0.034
71720399|NCT00958360|142956545|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71720400|NCT00958360|142956546|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71720401|NCT00958360|142956547|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71720402|NCT00958360|142956548|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
71720403|NCT00958360|142956549|SUPERIORITY_OR_OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
71720404|NCT00336284|142956552|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71720405|NCT00336284|142956553|NON_INFERIORITY_OR_EQUIVALENCE|Sample size of the study is based on the safety endpoint and based on a Blackwelder type test of non inferiority with the standard design criteria: Type I error (one-sided), statistical power of 80%, and 2:1 randomization. The evaluation of the primary safety endpoint was based on an exact binomial non-inferiority test comparing the proportions of patient deaths, strokes or surgical interventions.||||||0.005||95.0|||||Exact binomial test for non-inferiority|1-sided||||||0.005
71720406|NCT00336284|142956554|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|||||||0.016
71720407|NCT03308968|142956562|OTHER||Least square (LS) mean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-3.84|-2.42|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.42|-3.84|<0.0001
71720408|NCT03308968|142956562|OTHER||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-4.19|-2.78|||ANCOVA|||Analysis was performed using ANCOVA method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.||-2.78|-4.19|<0.0001
71720409|NCT02482298|142956600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.06367|||TWO_SIDED|90.0|-0.061|0.151|||Mixed Models Analysis|||||0.1510|-0.0610|
71720410|NCT02482298|142956600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0801|STANDARD_ERROR_OF_MEAN|0.06192|||TWO_SIDED|90.0|-0.023|0.1832|||Mixed Models Analysis|||||0.1832|-0.0230|
71720411|NCT02482298|142956602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1192|STANDARD_ERROR_OF_MEAN|0.05059|||TWO_SIDED|90.0|0.035|0.2035|||Mixed Models Analysis|||||0.2035|0.0350|
71720412|NCT02482298|142956602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0975|STANDARD_ERROR_OF_MEAN|0.04923|||TWO_SIDED|90.0|0.0155|0.1795|||Mixed Models Analysis|||||0.1795|0.0155|
71720413|NCT03782259|142956631|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
71720414|NCT03782259|142956632|SUPERIORITY||||||<|0.0125||||||Given that there were 4 separate comparisons of the primary outcomes, the level of significance was adjusted from 0.05 to 0.0125 (.05/4) using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|There were no adjustments for covariates.||||||< 0 .0125
71720415|NCT05507567|142956644|OTHER|||||||0.0331|||||||Chi-squared|||A priori primary analysis group||||0.0331
71769027|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.772|TWO_SIDED|95.0|-1.33|1.0|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.33|0.772
71769028|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.5||0.547|TWO_SIDED|95.0|-0.73|1.34|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.34|-0.73|0.547
71769029|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.57||0.65|TWO_SIDED|95.0|-1.43|0.91|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-1.43|0.650
71769030|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|95.0|-1.27|1.0|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.27|0.808
71720416|NCT05507567|142956645|OTHER|||||||0.1427||||||Hodges-Lehmann (H-L) estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1427
71720417|NCT05507567|142956646|OTHER|||||||0.1307||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.1307
71720418|NCT05507567|142956647|OTHER|||||||0.0382||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0382
71720419|NCT05507567|142956648|OTHER|||||||0.011||||||H-L estimation|Wilcoxon (Mann-Whitney)|1-sided Wilcoxon rank-sum||||||0.0110
71769031|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.55||0.915|TWO_SIDED|95.0|-1.19|1.07|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.07|-1.19|0.915
71720420|NCT03703232|142956662|SUPERIORITY|||||||0.092|||||||Wilcoxon signed-rank test|||||||0.092
71720421|NCT03703232|142956663|SUPERIORITY|||||||0.76|||||||Wilcoxon signed-rank test|||||||0.760
71720422|NCT03703232|142956664|SUPERIORITY|||||||0.007|||||||Wilcoxon signed-rank test|||||||0.007
71720423|NCT03703232|142956665|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank test|||||||0.003
71720424|NCT03703232|142956666|SUPERIORITY|||||||0.861|||||||Wilcoxon signed-rank test|||||||0.861
71720425|NCT03703232|142956668|SUPERIORITY|||||||0.405|||||||Wilcoxon signed-rank test|||||||0.405
71720426|NCT03703232|142956669|SUPERIORITY|||||||0.798|||||||Wilcoxon signed-rank test|||||||0.798
71720427|NCT03703232|142956670|SUPERIORITY|||||||0.382|||||||Wilcoxon signed-rank test|||||||0.382
71720428|NCT03703232|142956671|SUPERIORITY|||||||0.179|||||||Wilcoxon signed-rank test|||||||0.179
71720429|NCT03703232|142956672|SUPERIORITY|||||||0.984|||||||Wilcoxon signed-rank test|||||||0.984
71720430|NCT03726658|142956681|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.24||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.98
71720431|NCT03726658|142956681|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.|Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.25||0.25|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose). Since this was a phase 1 study no power calculation was performed.||||0.25
71720432|NCT03726658|142956681|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|2.26||0.93|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 2 (Day 1 post initial dose).||||0.93
71720433|NCT03726658|142956682|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group|Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.02||0.43|TWO_SIDED|||||a priori threshold for statistical significance was \<0.05|Mixed Models Analysis|||Chane from baseline in treated group compared to change from baseline in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
71720434|NCT03726658|142956682|EQUIVALENCE|Change from baseline in treated group compared to change in baseline in placebo group|Median Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.02||0.84|TWO_SIDED|||||The a priori threshold for statistical significance was P \<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change in placebo group. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.84
71720435|NCT03726658|142956683|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 9|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.69|TWO_SIDED|||||A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.69
71720436|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
71720437|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 9|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.43|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 9. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
71720438|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|2.65||0.55|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculaton was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.55
71769032|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.757|TWO_SIDED|95.0|-1.54|1.14|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.54|0.757
71769033|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.57||0.987|TWO_SIDED|95.0|-1.19|1.17|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.17|-1.19|0.987
71769034|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.64||0.781|TWO_SIDED|95.0|-1.14|1.51|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.14|0.781
71769035|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.61||0.834|TWO_SIDED|95.0|-1.13|1.38|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.38|-1.13|0.834
71769036|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.59||0.851|TWO_SIDED|95.0|-1.32|1.1|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.10|-1.32|0.851
71769037|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.68||0.701|TWO_SIDED|95.0|-1.68|1.15|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.15|-1.68|0.701
71769038|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.59||0.453|TWO_SIDED|95.0|-1.68|0.77|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.68|0.453
71769039|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.67||0.258|TWO_SIDED|95.0|-2.15|0.6|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.60|-2.15|0.258
71829644|NCT03622580|143163424|OTHER||Adjusted mean difference|-31.1|STANDARD_ERROR_OF_MEAN|6.35|||TWO_SIDED|95.0|-43.6|-18.6||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-18.6|-43.6|
71720439|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15.|Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.66||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.44
71720440|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 15|Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|2.69||0.56|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 15. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.56
71720441|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.74||0.8|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.80
71720442|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Median Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|2.74||0.45|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.45
71720443|NCT03726658|142956683|EQUIVALENCE|Change in MADRS score in treated groups compared to placebo group on Day 22.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|2.77||0.67|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change in MADRS score in treated groups compared to placebo group on Day 22. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.67
71720444|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.36||0.43|TWO_SIDED|||||a priori threshold for statistical significance was p\>0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.43
71720445|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 11|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.38||0.59|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 11. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.59
71720446|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|2.44||0.35|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14, Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.35
71769040|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.64||0.736|TWO_SIDED|95.0|-1.53|1.09|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.09|-1.53|0.736
71769041|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.64||0.491|TWO_SIDED|95.0|-1.76|0.87|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.87|-1.76|0.491
71769042|NCT00545129|143038264|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.62||0.695|TWO_SIDED|95.0|-1.53|1.04|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.04|-1.53|0.695
71769043|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.6||0.897|TWO_SIDED|95.0|-1.34|1.19|||ANCOVA|||Change at Week 1 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.19|-1.34|0.897
71769044|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.56||0.643|TWO_SIDED|95.0|-0.9|1.43|||ANCOVA|||Change at Week 2 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.43|-0.90|0.643
71829645|NCT03622580|143163424|OTHER||Adjusted mean difference|-23.9|STANDARD_ERROR_OF_MEAN|6.28|||TWO_SIDED|95.0|-36.2|-11.6||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-11.6|-36.2|
71829646|NCT03622580|143163427|OTHER||Difference in CMH Weighted Percentage|16.0|||||TWO_SIDED|95.0|8.9|23.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||23.1|8.9|
71829647|NCT03622580|143163427|OTHER||Difference in CMH Weighted Percentage|12.7|||||TWO_SIDED|95.0|5.4|20.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||20.0|5.4|
71720447|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 14|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.48||0.82|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 14. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.82
71720448|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.62||0.61|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.61
71720449|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 18|Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.69||0.47|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 18. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.47
71769045|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.464|TWO_SIDED|95.0|-1.45|0.68|||ANCOVA|||Change at Week 4 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.68|-1.45|0.464
71769046|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.56||0.593|TWO_SIDED|95.0|-1.46|0.86|||ANCOVA|||Change at Week 6 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.86|-1.46|0.593
71769047|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.61||0.423|TWO_SIDED|95.0|-1.77|0.77|||ANCOVA|||Change at Week 8 (Composite Score): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.77|-1.77|0.423
71769048|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.805|TWO_SIDED|95.0|-1.21|1.54|||ANCOVA|||Change at Week 1 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.54|-1.21|0.805
71769049|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.68||0.882|TWO_SIDED|95.0|-1.3|1.51|||ANCOVA|||Change at Week 2 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.51|-1.30|0.882
71769050|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.446|TWO_SIDED|95.0|-1.79|0.81|||ANCOVA|||Change at Week 4 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.81|-1.79|0.446
71769051|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.68||0.604|TWO_SIDED|95.0|-1.77|1.05|||ANCOVA|||Change at Week 6 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.05|-1.77|0.604
71769052|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.76||0.393|TWO_SIDED|95.0|-2.24|0.91|||ANCOVA|||Change at Week 8 (General Activity): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.91|-2.24|0.393
71769053|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.79||0.399|TWO_SIDED|95.0|-2.33|0.97|||ANCOVA|||Change at Week 1 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.97|-2.33|0.399
71769054|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.75||0.876|TWO_SIDED|95.0|-1.43|1.66|||ANCOVA|||Change at Week 2 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.66|-1.43|0.876
71769055|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.66||0.74|TWO_SIDED|95.0|-1.58|1.14|||ANCOVA|||Change at Week 4 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.14|-1.58|0.740
71769056|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.69||0.854|TWO_SIDED|95.0|-1.56|1.31|||ANCOVA|||Change at Week 6 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.31|-1.56|0.854
71829648|NCT03622580|143163427|OTHER||Difference in CMH Weighted Percentage|15.2|||||TWO_SIDED|95.0|7.3|23.2||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||23.2|7.3|
71829649|NCT03622580|143163427|OTHER||Difference in CMH Weighted Percentage|12.5|||||TWO_SIDED|95.0|4.4|20.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||20.6|4.4|
71720450|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.48||0.76|TWO_SIDED||||||Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study, no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.76
71720451|NCT03726658|142956684|EQUIVALENCE|Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|||||Change from baseline in treated group compared to change from baseline in placebo group on Day 21|Mixed Models Analysis|||Change from baseline in treated group compared to change from baseline in placebo group on Day 21. Since this was a phase 1 study no power calculation was performed. Statistical tests were 2-sided hypothesis tests performed at the 5% level of significance.||||0.99
71720452|NCT00412958|142956685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.796|TWO_SIDED|95.0|0.24|6.36|||Regression, Logistic|||P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||6.36|0.24|0.796
71720453|NCT00412958|142956685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.447|TWO_SIDED|95.0|0.39|8.36|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||8.36|0.39|0.447
71720454|NCT00412958|142956685|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28||||0.107|TWO_SIDED|95.0|0.77|13.95|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.||13.95|0.77|0.107
71720455|NCT00090779|142956717|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.005
71720456|NCT00090779|142956718|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71720457|NCT03012828|142956742|OTHER|The model was used for predicting population average and 90% 2-sided bootstrapped CI of the baseline-adjusted difference between active and placebo at each time point bound at clinically relevant concentrations.|Slope|-0.0077||||0.4727|TWO_SIDED|90.0|-0.0255|0.0101|||Mixed Models Analysis||The primary mixed effects model analysis revealed a nearly flat dQTcF - plasma concentration gradient|The primary analysis used a mixed-effects model to explore the relationship between the time-matched, baseline-adjusted QTcF (delta (d)QTcF) and moxidectin concentrations. dQTcF was a dependent variable and treatment, time point, and treatment by time point interaction as the independent variables with baseline QTcF as a covariate and time-matched concentrations of moxidectin as a covariate with random effects of intercept and slope for each subject.Concentrations of zero were used for placebo.||0.0101|-0.0255|0.4727
71720458|NCT04855240|142956768|SUPERIORITY||LSM difference|-10.5|STANDARD_ERROR_OF_MEAN|7.61||0.1683|TWO_SIDED|95.0|-25.4|4.4|||ANOVA|||||4.4|-25.4|0.1683
71769057|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.78||0.436|TWO_SIDED|95.0|-2.24|1.0|||ANCOVA|||Change at Week 8 (Walking Ability): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-2.24|0.436
71769058|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.087|TWO_SIDED|95.0|-2.81|0.21|||ANCOVA|||Change at Week 1 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.21|-2.81|0.087
71769059|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.75||0.278|TWO_SIDED|95.0|-2.4|0.72|||ANCOVA|||Change at Week 2 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.72|-2.40|0.278
71769060|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.69||0.548|TWO_SIDED|95.0|-1.84|1.0|||ANCOVA|||Change at Week 4 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||1.00|-1.84|0.548
71887483|NCT02167945|143295844|SUPERIORITY||Cox Proportional Hazard Ratio|0.031||||0.007|TWO_SIDED|95.0|0.003|0.38|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.380|0.003|0.007
71720459|NCT04855240|142956768|SUPERIORITY||LSM difference|1.6|STANDARD_ERROR_OF_MEAN|7.64||0.8356|TWO_SIDED|95.0|-13.4|16.6|||ANOVA|||||16.6|-13.4|0.8356
71720460|NCT04855240|142956769|SUPERIORITY||Hazard Ratio (HR)|0.831||||0.228|TWO_SIDED|95.0|0.598|1.155|||Log Rank|||||1.155|0.598|0.2280
71720461|NCT04855240|142956769|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5604|TWO_SIDED|95.0|0.793|1.527|||Log Rank|||||1.527|0.793|0.5604
71720462|NCT04855240|142956770|SUPERIORITY||Risk Difference (RD)|0.11||||0.2457|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.05|0.2457
71720463|NCT04855240|142956770|SUPERIORITY||Risk Difference (RD)|-0.06||||0.3997|TWO_SIDED|95.0|-0.22|0.09|||Cochran-Mantel-Haenszel|||||0.09|-0.22|0.3997
71720464|NCT04855240|142956771|SUPERIORITY||Risk Difference (RD)|0.07||||0.4771|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4771
71769061|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.75||0.318|TWO_SIDED|95.0|-2.33|0.79|||ANCOVA|||Change at Week 6 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.79|-2.33|0.318
71720465|NCT04855240|142956771|SUPERIORITY||Risk Difference (RD)|-0.09||||0.2925|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.2925
71720466|NCT04855240|142956772|SUPERIORITY||Risk Difference (RD)|0.07||||0.4628|TWO_SIDED|95.0|-0.09|0.22|||Cochran-Mantel-Haenszel|||||0.22|-0.09|0.4628
71720467|NCT04855240|142956772|SUPERIORITY||Risk Difference (RD)|-0.09||||0.309|TWO_SIDED|95.0|-0.24|0.06|||Cochran-Mantel-Haenszel|||||0.06|-0.24|0.3090
71720468|NCT04855240|142956773|SUPERIORITY||LSM difference|-17.7|STANDARD_ERROR_OF_MEAN|15.36||0.2494|TWO_SIDED|95.0|-47.8|12.4|||ANOVA|||||12.4|-47.8|0.2494
71720469|NCT04855240|142956773|SUPERIORITY||LSM difference|5.1|STANDARD_ERROR_OF_MEAN|15.42||0.7385|TWO_SIDED|95.0|-25.1|35.4|||ANOVA|||||35.4|-25.1|0.7385
71720470|NCT04855240|142956774|SUPERIORITY||LSM difference|-22.6|STANDARD_ERROR_OF_MEAN|22.91||0.3238|TWO_SIDED|95.0|-67.5|22.3|||ANOVA|||||22.3|-67.5|0.3238
71720471|NCT04855240|142956774|SUPERIORITY||LSM difference|7.8|STANDARD_ERROR_OF_MEAN|22.99||0.7344|TWO_SIDED|95.0|-37.3|52.9|||ANOVA|||||52.9|-37.3|0.7344
71769062|NCT00545129|143038265|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.73||0.484|TWO_SIDED|95.0|-2.02|0.99|||ANCOVA|||Change at Week 8 (Normal Work): ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.99|-2.02|0.484
71769063|NCT00545129|143038266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1: P-value was calculated by Cochran-Mantel-Haenszel (CMH test) stratified by center.||||0.399
71769064|NCT00545129|143038266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: P-value was calculated by CMH test stratified by center.||||0.779
71769065|NCT00545129|143038266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.922|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: P-value was calculated by CMH test stratified by center.||||0.922
71887484|NCT02167945|143295845|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71657073|NCT02944383|142831654|SUPERIORITY|||||||0.3714||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.3714
71720472|NCT04855240|142956775|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|1.72||0.8489|TWO_SIDED|95.0|-3.7|3.0|||ANOVA|||||3.0|-3.7|0.8489
71720473|NCT04855240|142956775|SUPERIORITY||LSM difference|1.9|STANDARD_ERROR_OF_MEAN|1.72||0.2768|TWO_SIDED|95.0|-1.5|5.3|||ANOVA|||||5.3|-1.5|0.2768
71720474|NCT04855240|142956776|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|2.54||0.6291|TWO_SIDED|95.0|-6.2|3.8|||ANOVA|||||3.8|-6.2|0.6291
71720475|NCT04855240|142956776|SUPERIORITY||LSM difference|2.5|STANDARD_ERROR_OF_MEAN|2.55||0.3182|TWO_SIDED|95.0|-2.5|7.5|||ANOVA|||||7.5|-2.5|0.3182
71720476|NCT04855240|142956777|SUPERIORITY||LSM difference|-4.2|STANDARD_ERROR_OF_MEAN|4.35||0.3299|TWO_SIDED|95.0|-12.8|4.3|||ANOVA|||||4.3|-12.8|0.3299
71720477|NCT04855240|142956777|SUPERIORITY||LSM difference|0.6|STANDARD_ERROR_OF_MEAN|4.37||0.8822|TWO_SIDED|95.0|-7.9|9.2|||ANOVA|||||9.2|-7.9|0.8822
71720478|NCT04855240|142956778|SUPERIORITY||LSM difference|-7.1|STANDARD_ERROR_OF_MEAN|8.62||0.4094|TWO_SIDED|95.0|-24.0|9.8|||ANOVA|||||9.8|-24.0|0.4094
71720479|NCT04855240|142956778|SUPERIORITY||LSM difference|3.4|STANDARD_ERROR_OF_MEAN|8.65||0.6901|TWO_SIDED|95.0|-13.5|20.4|||ANOVA|||||20.4|-13.5|0.6901
71720480|NCT04855240|142956779|SUPERIORITY||LSM difference|-5.1|STANDARD_ERROR_OF_MEAN|8.59||0.5536|TWO_SIDED|95.0|-21.9|11.7|||ANOVA|||||11.7|-21.9|0.5536
71720481|NCT04855240|142956779|SUPERIORITY||LSM difference|2.4|STANDARD_ERROR_OF_MEAN|8.64||0.7811|TWO_SIDED|95.0|-14.5|19.3|||ANOVA|||||19.3|-14.5|0.7811
71720482|NCT04855240|142956780|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.5267|TWO_SIDED|95.0|-0.8|0.4|||ANOVA|||||0.4|-0.8|0.5267
71720483|NCT04855240|142956780|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3228|TWO_SIDED|95.0|-0.3|0.9|||ANOVA|||||0.9|-0.3|0.3228
71720484|NCT04855240|142956781|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7617|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.7617
71720485|NCT04855240|142956781|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6241|TWO_SIDED|95.0|-0.4|0.6|||ANOVA|||||0.6|-0.4|0.6241
71720486|NCT04855240|142956782|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3442|TWO_SIDED|95.0|-0.5|0.2|||ANOVA|||||0.2|-0.5|0.3442
71720487|NCT04855240|142956782|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.7896|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.7896
71720488|NCT04855240|142956783|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.6003|TWO_SIDED|95.0|-1.2|0.7|||ANOVA|||||0.7|-1.2|0.6003
71769066|NCT00545129|143038266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.811|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 6: P-value was calculated by CMH test stratified by center.||||0.811
71769067|NCT00545129|143038266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: P-value was calculated by CMH test stratified by center.||||0.237
71769068|NCT00545129|143038267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
71769069|NCT00545129|143038267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.202|TWO_SIDED|95.0|-0.7|0.16|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.16|-0.70|0.202
71887485|NCT02167945|143295845|SUPERIORITY||Cox Proportional Hazard Ratio|0.038|||<|0.001|TWO_SIDED|95.0|0.009|0.156|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.156|0.009|<0.001
71887486|NCT02167945|143295846|SUPERIORITY|||||||0.86|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.860
71887487|NCT02167945|143295846|SUPERIORITY|||||||0.997||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.997
71720489|NCT04855240|142956783|SUPERIORITY||LSM difference|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.4086|TWO_SIDED|95.0|-0.6|1.4|||ANOVA|||||1.4|-0.6|0.4086
71720490|NCT04855240|142956784|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.61||0.4958|TWO_SIDED|95.0|-1.6|0.8|||ANOVA|||||0.8|-1.6|0.4958
71720491|NCT04855240|142956784|SUPERIORITY||LSM difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4595|TWO_SIDED|95.0|-0.8|1.7|||ANOVA|||||1.7|-0.8|0.4595
71720492|NCT04855240|142956785|SUPERIORITY||Risk Difference (RD)|0.08||||0.1686|TWO_SIDED|95.0|-0.04|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.04|0.1686
71720493|NCT04855240|142956785|SUPERIORITY||Risk Difference (RD)|0.0||||0.8333|TWO_SIDED|95.0|-0.1|0.11|||Cochran-Mantel-Haenszel|||||0.11|-0.10|0.8333
71720494|NCT04855240|142956786|SUPERIORITY||Risk Difference (RD)|0.09||||0.1939|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1939
71720495|NCT04855240|142956786|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
71887488|NCT02167945|143295847|SUPERIORITY|||||||0.608|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||0.608
71720496|NCT04855240|142956787|SUPERIORITY||Risk Difference (RD)|0.09||||0.1894|TWO_SIDED|95.0|-0.02|0.2|||Cochran-Mantel-Haenszel|||||0.20|-0.02|0.1894
71720497|NCT04855240|142956787|SUPERIORITY||Risk Difference (RD)|0.0||||0.9595|TWO_SIDED|95.0|-0.1|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.10|0.9595
71720498|NCT04855240|142956788|SUPERIORITY||Risk Difference (RD)|0.09||||0.7117|TWO_SIDED|95.0|-0.06|0.24|||Cochran-Mantel-Haenszel|||||0.24|-0.06|0.7117
71769070|NCT00545129|143038267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.571|TWO_SIDED|95.0|-0.54|0.3|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.30|-0.54|0.571
71720499|NCT04855240|142956788|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7599|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.7599
71769071|NCT00545129|143038267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.808|TWO_SIDED|95.0|-0.55|0.43|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.43|-0.55|0.808
71720500|NCT04855240|142956789|SUPERIORITY||Risk Difference (RD)|0.0||||0.707|TWO_SIDED|95.0|-0.16|0.16|||Cochran-Mantel-Haenszel|||||0.16|-0.16|0.7070
71720501|NCT04855240|142956789|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6877|TWO_SIDED|95.0|-0.2|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.20|0.6877
71720502|NCT04855240|142956790|SUPERIORITY||Risk Difference (RD)|-0.07||||0.869|TWO_SIDED|95.0|-0.22|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.22|0.8690
71720503|NCT04855240|142956790|SUPERIORITY||Risk Difference (RD)|-0.04||||0.379|TWO_SIDED|95.0|-0.19|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.19|0.3790
71720504|NCT04855240|142956791|SUPERIORITY||LSM difference|5.9|STANDARD_ERROR_OF_MEAN|3.49||0.0897|TWO_SIDED|95.0|-0.9|12.8|||ANOVA|||||12.8|-0.9|0.0897
71720505|NCT04855240|142956791|SUPERIORITY||LSM difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5||0.9434|TWO_SIDED|95.0|-7.1|6.7|||ANOVA|||||6.7|-7.1|0.9434
71720506|NCT04855240|142956792|SUPERIORITY||Risk Difference (RD)|0.09||||0.8355|TWO_SIDED|95.0|-0.04|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.04|0.8355
71720507|NCT04855240|142956792|SUPERIORITY||Risk Difference (RD)|0.02||||0.3561|TWO_SIDED|95.0|-0.12|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.12|0.3561
71720508|NCT04855240|142956793|SUPERIORITY||Risk Difference (RD)|0.04||||0.9413|TWO_SIDED|95.0|-0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.06|0.9413
71720509|NCT04855240|142956793|SUPERIORITY||Risk Difference (RD)|-0.04||||0.7819|TWO_SIDED|95.0|-0.15|0.07|||Cochran-Mantel-Haenszel|||||0.07|-0.15|0.7819
71720510|NCT04855240|142956794|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.8461|TWO_SIDED|95.0|-0.5|0.4|||ANOVA|||||0.4|-0.5|0.8461
71769072|NCT00545129|143038267|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.913|TWO_SIDED|95.0|-0.57|0.51|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.51|-0.57|0.913
71720511|NCT04855240|142956794|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
71720512|NCT04855240|142956795|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9022|TWO_SIDED|95.0|-0.4|0.5|||ANOVA|||||0.5|-0.4|0.9022
71720513|NCT04855240|142956795|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.245|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2450
71720514|NCT04855240|142956796|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.4205||0.4205|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4205
71720515|NCT04855240|142956796|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4336|TWO_SIDED|95.0|-0.2|0.6|||ANOVA|||||0.6|-0.2|0.4336
71720516|NCT04855240|142956797|SUPERIORITY||LSM difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2718|TWO_SIDED|95.0|-0.2|0.7|||ANOVA|||||0.7|-0.2|0.2718
71720517|NCT04855240|142956797|SUPERIORITY||LSM difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1727|TWO_SIDED|95.0|-0.1|0.7|||ANOVA|||||0.7|-0.1|0.1727
71720518|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.05|TWO_SIDED|95.0|1.8|10.8|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.8|1.8|<0.05
71769073|NCT00545129|143038268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.108|TWO_SIDED|95.0|-0.82|0.09|||ANCOVA|||Change at Week 1: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.09|-0.82|0.108
71769074|NCT00545129|143038268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.21||0.339|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 2: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.23|-0.65|0.339
71769075|NCT00545129|143038268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.408|TWO_SIDED|95.0|-0.67|0.28|||ANCOVA|||Change at Week 4: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.28|-0.67|0.408
71720519|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-13.6|10.3|||Regression, Linear||The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||10.3|-13.6|<0.05
71769076|NCT00545129|143038268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.27||0.686|TWO_SIDED|95.0|-0.67|0.45|||ANCOVA|||Change at Week 6: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.45|-0.67|0.686
71769077|NCT00545129|143038268|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.3||0.493|TWO_SIDED|95.0|-0.81|0.4|||ANCOVA|||Change at Week 8: ANCOVA model included treatment and cancer type as fixed effects, baseline value as a covariate and study site as a random effect. LS mean difference and corresponding 95% CI were estimated from the corresponding ANCOVA model.||0.40|-0.81|0.493
71769078|NCT00545129|143038269|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
71769079|NCT00545129|143038269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.947|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract method.||||0.947
71720520|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||<|0.05|TWO_SIDED|95.0|-5.4|6.5|||Regression, Linear||The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||6.5|-5.4|<0.05
71720521|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.05|TWO_SIDED|95.0|-8.9|1.1|||Regression, Linear||The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-8.9|<0.05
71769080|NCT00545129|143038269|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
71769081|NCT00545129|143038269|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
71769082|NCT00545129|143038269|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.759|TWO_SIDED|95.0|0.12|18.86|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||18.86|0.12|0.759
71720522|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED|95.0|-0.5|1.1|||Regression, Linear||The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-0.5|<0.05
71720523|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-0.5|0.0|||Regression, Linear||The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.0|-0.5|<0.05
71720524|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.05|TWO_SIDED|95.0|-4.9|3.4|||Regression, Linear||The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||3.4|-4.9|<0.05
71720525|NCT01539070|142956813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.05|TWO_SIDED|95.0|-8.4|4.1|||Regression, Linear||The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||4.1|-8.4|<0.05
71720526|NCT01539070|142956814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.05|TWO_SIDED|95.0|-29.1|5.5|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.||5.5|-29.1|<0.05
71720527|NCT01539070|142956814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.2|0.5|||Regression, Linear||The change in mean sleep time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.5|-0.2|<0.05
71720528|NCT01539070|142956814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-4.4|1.1|||Regression, Linear||The change in mean screen time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||1.1|-4.4|<0.05
71720529|NCT01539070|142956816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.05|TWO_SIDED|95.0|-0.04|0.35|||Regression, Linear|||In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.||0.35|-0.04|<0.05
71769083|NCT00545129|143038270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.58||||0.724|TWO_SIDED|95.0|0.03|12.27|||Fisher Exact|||Week 1: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||12.27|0.03|0.724
71769084|NCT00545129|143038270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|TWO_SIDED||||||Fisher Exact|||Week 2: P-value was calculated using Fisher Extract test.||||0.950
71769085|NCT00545129|143038270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.634|TWO_SIDED|95.0|0.03|8.71|||Fisher Exact|||Week 4: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||8.71|0.03|0.634
71769086|NCT00545129|143038270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03||||0.975|TWO_SIDED|95.0|0.14|7.74|||Fisher Exact|||Week 6: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||7.74|0.14|0.975
71769087|NCT00545129|143038270|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.578|TWO_SIDED|95.0|0.17|23.89|||Fisher Exact|||Week 8: The odds ratio with 95% 2-sided CI for the treatment contrast was given.||23.89|0.17|0.578
71769088|NCT01894568|143038283|NON_INFERIORITY_OR_EQUIVALENCE|0.4% is the margin of Non-inferiority|LS Mean Difference|-0.24||||0.005|TWO_SIDED|95.0|-0.41|-0.07|||Mixed Models Analysis|||||-0.07|-0.41|0.005
71720530|NCT02998671|142956817|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.18|||||TWO_SIDED|90.0|0.79|1.81|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.81|0.79|
71720531|NCT02998671|142956817|SUPERIORITY|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.1|||||TWO_SIDED|90.0|0.66|1.8|||Bayesian model for repeated measurements||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value \> 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The credible interval was calculated and presented under confidence interval."|||1.80|0.66|
71720532|NCT00418093|142956845|SUPERIORITY_OR_OTHER||Proportion|0.684|||||TWO_SIDED|95.0|0.43|0.87||Exact 95% CI for the partial response rate (13/19 = 0.684): 43.4% \~ 87.4%|Estimation of PR based on Binomial Model|We did not perform a test. Point estimate of PR and its exact 95% CI based on Binomial Model is provided. Thus there is no p-value to report.|Point estimate of PR and its exact 95% CI based on Binomial Model|||0.87|0.43|
71720533|NCT00418093|142956845|SUPERIORITY_OR_OTHER||Single Proportion|0.684|||||TWO_SIDED|95.0|0.434|0.874||We did not perform hypothesis test. We made an estimation for a single proportion (partial response) with its two-sided 95% exact Binomial confidence interval.|Fisher Exact||Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval|||0.874|0.434|
71720534|NCT03162796|142956849|SUPERIORITY||Difference in percentage|29.8|||<|0.001|TWO_SIDED|95.0|18.6|41.1|||Cochran-Mantel-Haenszel|||||41.1|18.6|< 0.001
71720535|NCT03162796|142956849|SUPERIORITY||Difference in percentage|37.1|||<|0.001|TWO_SIDED|95.0|26.1|48.2|||Cochran-Mantel-Haenszel|||||48.2|26.1|< 0.001
71720536|NCT03162796|142956850|SUPERIORITY||Least Square (LS) Mean Difference|-0.2483|||<|0.001|TWO_SIDED|95.0|-0.364|-0.1325|||ANCOVA|||||-0.1325|-0.3640|< 0.001
71720537|NCT03162796|142956850|SUPERIORITY||LS Mean difference|-0.3226|||<|0.001|TWO_SIDED|95.0|-0.4385|-0.2066|||ANCOVA|||||-0.2066|-0.4385|< 0.001
71720538|NCT03162796|142956851|SUPERIORITY||Difference in percentage|21.4|||<|0.001|TWO_SIDED|95.0|12.1|30.7||Nominal|Cochran-Mantel-Haenszel|||||30.7|12.1|< 0.001
71720539|NCT03162796|142956851|SUPERIORITY||Difference in percentage|27.2|||<|0.001|TWO_SIDED|95.0|17.6|36.8||Nominal|Cochran-Mantel-Haenszel|||||36.8|17.6|< 0.001
71720540|NCT03162796|142956852|SUPERIORITY||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|28.9|55.1|||Cochran-Mantel-Haenszel|||||55.1|28.9|< 0.001
71720541|NCT03162796|142956852|SUPERIORITY||Difference in percentage|60.0|||<|0.001|TWO_SIDED|95.0|48.3|71.8|||Cochran-Mantel-Haenszel|||||71.8|48.3|< 0.001
71720542|NCT03162796|142956853|SUPERIORITY||Difference in percentage|26.7|||<|0.001|TWO_SIDED|95.0|15.3|38.1||Nominal|Cochran-Mantel-Haenszel|||||38.1|15.3|< 0.001
71720543|NCT03162796|142956853|SUPERIORITY||Difference in percentage|34.8|||<|0.001|TWO_SIDED|95.0|23.5|46.0||Nominal|Cochran-Mantel-Haenszel|||||46.0|23.5|< 0.001
71720544|NCT03162796|142956854|SUPERIORITY||LS Mean difference|-0.73|||<|0.001||95.0|-0.98|-0.48||Nominal|ANCOVA|||||-0.48|-0.98|< 0.001
71720545|NCT03162796|142956854|SUPERIORITY||LS Mean difference|-0.91|||<|0.001||95.0|-1.16|-0.66||Nominal|ANCOVA|||||-0.66|-1.16|< 0.001
71720546|NCT03162796|142956855|SUPERIORITY||Difference in percentage|6.4||||0.069|TWO_SIDED|95.0|-0.3|13.1|||Cochran-Mantel-Haenszel|||||13.1|-0.3|0.069
71720547|NCT03162796|142956855|SUPERIORITY||Difference in percentage|14.8|||<|0.001|TWO_SIDED|95.0|6.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|6.9|< 0.001
71720548|NCT03162796|142956856|SUPERIORITY||Difference in percentage|10.2||||0.036|TWO_SIDED|95.0|1.0|19.3||Nominal|Cochran-Mantel-Haenszel|||||19.3|1.0|0.036
71769089|NCT04545944|143038301|OTHER||Geometric Least Squares Mean Ratio|192.4|||||TWO_SIDED|90.0|152.8|242.4||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||242.4|152.8|
71769090|NCT04545944|143038302|OTHER||Geometric Least Squares Mean Ratio|188.9|||||TWO_SIDED|90.0|150.6|236.9||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||236.9|150.6|
71769091|NCT04545944|143038303|OTHER||Geometric Least Squares Mean Ratio|193.4|||||TWO_SIDED|90.0|160.5|233.1||||||A linear mixed model with treatment as a fixed effect and participant as a random effect was performed on the natural log-transformed values to assess the effect of vonoprazan on the PK of midazolam.||233.1|160.5|
71769092|NCT01514370|143038309|OTHER|||||||0.271|||||||Chi-squared|||||||0.271
71720549|NCT03162796|142956856|SUPERIORITY||Difference in percentage|13.9||||0.006|TWO_SIDED|95.0|4.4|23.4||Nominal|Cochran-Mantel-Haenszel|||||23.4|4.4|0.006
71720550|NCT03162796|142956857|SUPERIORITY||LS Mean difference|4.14|||<|0.001|TWO_SIDED|95.0|2.42|5.85|||ANCOVA|||||5.85|2.42|< 0.001
71720551|NCT03162796|142956857|SUPERIORITY||LS Mean difference|4.91|||<|0.001||95.0|3.19|6.63|||ANCOVA|||||6.63|3.19|< 0.001
71720552|NCT03162796|142956858|SUPERIORITY||Difference in percentage|13.0||||0.094|TWO_SIDED|95.0|-1.6|27.5||Nominal|Cochran-Mantel-Haenszel|||||27.5|-1.6|0.094
71720553|NCT03162796|142956858|SUPERIORITY||Difference in percentage|19.8||||0.013|TWO_SIDED|95.0|4.9|34.6||Nominal|Cochran-Mantel-Haenszel|||||34.6|4.9|0.013
71720554|NCT03162796|142956859|SUPERIORITY||LS Mean difference|-0.33||||0.185|TWO_SIDED|95.0|-0.83|0.16||Nominal|ANCOVA|||||0.16|-0.83|0.185
71720555|NCT03162796|142956859|SUPERIORITY||LS Mean difference|-0.74||||0.004|TWO_SIDED|95.0|-1.24|-0.24||Nominal|ANCOVA|||||-0.24|-1.24|0.004
71720556|NCT03162796|142956860|SUPERIORITY||LS Mean difference|0.83||||0.398|TWO_SIDED|95.0|-1.1|2.77||Nominal|ANCOVA|||||2.77|-1.10|0.398
71720557|NCT03162796|142956860|SUPERIORITY||LS Mean difference|1.23||||0.214|TWO_SIDED|95.0|-0.71|3.16||Nominal|ANCOVA|||||3.16|-0.71|0.214
71720558|NCT03162796|142956861|SUPERIORITY||Difference in percentage|16.6||||0.088|TWO_SIDED|95.0|-1.5|34.8||Nominal|Cochran-Mantel-Haenszel|||||34.8|-1.5|0.088
71720559|NCT03162796|142956861|SUPERIORITY||Difference in percentage|13.4||||0.212|TWO_SIDED|95.0|-6.9|33.7||Nominal|Cochran-Mantel-Haenszel|||||33.7|-6.9|0.212
71769093|NCT01551420|143038330|SUPERIORITY|Null hypothesis of no change after home use|Mean Difference (Net)|0.002|STANDARD_DEVIATION|0.68||0.9358|TWO_SIDED|95.0|-0.27|0.28||Two way comparison between scores at baseline and after 9-12 weeks of Prosthetic use. Alpha=0.05|t-test, 2 sided|paired t-tests||||0.28|-0.27|.9358
71887489|NCT02167945|143295847|SUPERIORITY|||||||0.992||||||The Hazard Ratio for experiencing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to those who did not achieve SVR12 is infinite and the CI is not bounded due to zero events in one of the groups.|Cox proportional hazards model|||A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||||0.992
71720560|NCT03162796|142956862|SUPERIORITY||LS Mean difference|-1.82||||0.121|TWO_SIDED|95.0|-4.12|0.49||Nominal|ANCOVA|||||0.49|-4.12|0.121
71720561|NCT03162796|142956862|SUPERIORITY||LS Mean difference|-1.53||||0.225|TWO_SIDED|95.0|-4.0|0.95||Nominal|ANCOVA|||||0.95|-4.00|0.225
71720562|NCT02473471|142956954|OTHER|The sample size was calculated based on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups (effect size= 0.8), the power analysis yielded 28 subjects per group at a conventional alpha level (p = 0.05) and desired power (1 - β) of 0.90||||||0.77|||||||t-test, 2 sided|||||||0.77
71720563|NCT02473471|142956955|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.50
71720564|NCT02473471|142956956|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
71769094|NCT01551420|143038330|SUPERIORITY||Slope|-0.69||||0.08|TWO_SIDED|95.0|-1.47|0.09|||Regression, Linear|||Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-1.47|0.08
71769095|NCT01551420|143038331|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.42|<|0.0001|TWO_SIDED|95.0|0.17|0.43|||t-test, 2 sided|The sample for this analyses was 44 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).||0.43|0.17|<0.0001
71769096|NCT01551420|143038331|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.73|-0.4|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.40|-0.73|<0.0001
71769097|NCT01551420|143038332|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_DEVIATION|0.94||0.186|TWO_SIDED|95.0|-0.55|0.11|||t-test, 2 sided|The sample for this analysis was 34 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).||0.11|-0.55|0.186
71769098|NCT01551420|143038332|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|0.44||0.0168|TWO_SIDED|95.0|-2.06|-0.23|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.23|-2.06|0.0168
71769099|NCT01551420|143038333|SUPERIORITY||Mean Difference (Net)|-0.97|STANDARD_DEVIATION|5.61||0.3367|TWO_SIDED|95.0|-2.99|1.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||1.05|-2.99|0.3367
71769100|NCT01551420|143038333|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.49||0.6339|TWO_SIDED|95.0|-3.84|2.39|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.39|-3.84|0.6339
71769101|NCT01551420|143038334|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_DEVIATION|18.8||0.5465|TWO_SIDED|95.0|-7.53|4.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).||4.05|-7.53|0.5465
71769102|NCT01551420|143038334|SUPERIORITY||Mean Difference (Net)|-3.78|STANDARD_DEVIATION|17.37||0.161|TWO_SIDED|95.0|-9.12|1.57|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).||1.57|-9.12|0.1610
71720565|NCT02473471|142956957|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
71720566|NCT02473471|142956958|OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
71720567|NCT02473471|142956959|OTHER|||||||0.74||||||There was no significant difference in tooth movement between control and MOP sides from baseline to 1st, 2nd and 3rd months. P Value \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.74
71720568|NCT02473471|142956960|OTHER|||||||0.59|||||||t-test, 2 sided|||Root length at baseline.||||0.59
71720569|NCT02473471|142956960|OTHER|||||||0.48|||||||t-test, 2 sided|||Root length at 3 months||||0.48
71720570|NCT02473471|142956961|OTHER|||||||0.388|||||||t-test, 2 sided|||Immediate after intervention||||0.388
71720571|NCT02473471|142956961|OTHER|||||||0.092|||||||t-test, 2 sided|||1 hour after intervention||||0.092
71720572|NCT02473471|142956961|OTHER|||||||0.1|||||||t-test, 2 sided|||12 hour after intervention||||0.100
71720573|NCT02473471|142956961|OTHER|||||||0.302|||||||t-test, 2 sided|||Day 1 after intervention||||0.302
71769103|NCT01551420|143038334|SUPERIORITY||Mean Difference (Net)|-0.61|STANDARD_DEVIATION|13.9||0.7765|TWO_SIDED|95.0|-4.9|3.68|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).||3.68|-4.90|0.7765
71769104|NCT01551420|143038334|SUPERIORITY||Slope|-13.35|STANDARD_ERROR_OF_MEAN|6.91||0.0669|TWO_SIDED|95.0|-27.72|1.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.02|-27.72|0.0669
71769105|NCT01551420|143038334|SUPERIORITY||Slope|-8.24|STANDARD_ERROR_OF_MEAN|7.1||0.2592|TWO_SIDED|95.0|-23.01|6.54|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||6.54|-23.01|0.2592
71769106|NCT01551420|143038334|SUPERIORITY||Slope|-30.23|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|-43.23|-17.23|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-17.23|-43.23|<0.0001
71769107|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.17||0.6691|TWO_SIDED|95.0|-0.05|0.07|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).||0.07|-0.05|0.6691
71769108|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.06||0.0511|TWO_SIDED|95.0|-0.05|0.0|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).||0.00|-0.05|0.0511
71887490|NCT02167945|143295848|SUPERIORITY||||||<|0.001|||||||Log-rank test|||Comparisons between participants in studies M14-222 and M14-423 who achieved SVR12 and those who did not were performed using a log-rank test.||||<0.001
71769109|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.09||0.5942|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).||0.04|-0.02|0.5942
71769110|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.08||0.0101|TWO_SIDED|95.0|-0.07|-0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).||-0.01|-0.07|0.0101
71769111|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.09||0.1063|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).||0.01|-0.06|0.1063
71769112|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_DEVIATION|0.12||0.2474|TWO_SIDED|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).||0.01|-0.06|0.2474
71720574|NCT02473471|142956961|OTHER|||||||0.582|||||||t-test, 2 sided|||Day 3 after intervention||||0.582
71720575|NCT02473471|142956961|OTHER|||||||0.743|||||||t-test, 2 sided|||Day 5 after intervention||||0.743
71720576|NCT02473471|142956961|OTHER|||||||0.809|||||||t-test, 2 sided|||Day 7 after intervention||||0.809
71720577|NCT02473471|142956962|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 1||||0.09
71720578|NCT02473471|142956962|OTHER|||||||0.29|||||||t-test, 2 sided|||Day 3||||0.29
71720579|NCT02473471|142956962|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 5||||0.57
71720580|NCT02473471|142956962|OTHER|||||||0.82|||||||t-test, 2 sided|||Day 7||||0.82
71720581|NCT02473471|142956963|OTHER|||||||0.27|||||||t-test, 2 sided|||Day 1||||0.27
71720582|NCT02473471|142956963|OTHER|||||||0.37|||||||t-test, 2 sided|||Day 3||||0.37
71720583|NCT02473471|142956963|OTHER|||||||0.33|||||||t-test, 2 sided|||Day 5||||0.33
71720584|NCT02473471|142956963|OTHER||||||>|0.05|||||||t-test, 2 sided|||Day 7||||> 0.05
71720585|NCT02473471|142956964|OTHER|||||||0.05|||||||t-test, 2 sided|||Day 1||||0.05
71720586|NCT02473471|142956964|OTHER|||||||0.47|||||||t-test, 2 sided|||Day 3||||0.47
71720587|NCT02473471|142956964|OTHER|||||||0.09|||||||t-test, 2 sided|||Day 5||||0.09
71720588|NCT02473471|142956964|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71720589|NCT02473471|142956965|OTHER|||||||0.18|||||||t-test, 2 sided|||Day 1||||0.18
71720590|NCT02473471|142956965|OTHER|||||||0.57|||||||t-test, 2 sided|||Day 3||||0.57
71720591|NCT02473471|142956965|OTHER|||||||0.3|||||||t-test, 2 sided|||Day 5||||0.30
71720592|NCT02473471|142956965|OTHER|||||||0.56|||||||t-test, 2 sided|||Day 7||||0.56
71720593|NCT02473471|142956966|OTHER||||||<|0.05|||||||Descriptive statistics|||||||< 0.05
71720594|NCT01181804|142956978|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|1.07|1.15|||ANOVA|||||1.15|1.07|
71720595|NCT01181804|142956979|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.32|1.54|||ANOVA|||||1.54|1.32|
71769113|NCT01551420|143038335|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.14||0.1604|TWO_SIDED|95.0|-0.09|0.02|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).||0.02|-0.09|0.1604
71769114|NCT01551420|143038335|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.4208|TWO_SIDED|95.0|-0.12|0.09|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.09|-0.12|0.4208
71769115|NCT01551420|143038335|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1959|TWO_SIDED|95.0|-0.09|0.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.02|-0.09|0.1959
71769116|NCT01551420|143038335|SUPERIORITY|Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3328|TWO_SIDED|95.0|-0.09|0.03|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.03|-0.09|0.3328
71769117|NCT01551420|143038335|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6585|TWO_SIDED|95.0|-0.05|0.08|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.08|-0.05|0.6585
71769118|NCT01551420|143038335|SUPERIORITY|Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0552|TWO_SIDED|95.0|-0.12|0.0|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|||0.00|-0.12|0.0552
71720596|NCT01181804|142956980|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.1|||||TWO_SIDED|95.0|1.06|1.14|||ANOVA|||||1.14|1.06|
71720597|NCT01181804|142956981|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.15|||||TWO_SIDED|90.0|1.09|1.21|||ANOVA|||||1.21|1.09|
71829650|NCT01930045|143163463|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.4||||0.507|TWO_SIDED|90.0|0.31|0.52|||Hochberg step-up procedure||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs geometric mean ratio (GMR) is not less than 0.4||0.52|0.31|0.507
71829651|NCT01930045|143163463|SUPERIORITY_OR_OTHER||GMR|0.38||||0.624|TWO_SIDED|90.0|0.3|0.49|||Hochberg step-up procedure||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.49|0.30|0.624
71720598|NCT03163134|142956987|OTHER|||||||0.017|||||||Chi-squared|||||||0.017
71720599|NCT03163134|142956988|OTHER|||||||0.577|||||||Chi-squared|||||||0.577
71720600|NCT02195700|142957040|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0188|TWO_SIDED|95.0|-2.6|-0.2||5% level of significance (2-sided)|unstructured covariance|||The linear mixed model for repeated measurements (MMRM) included fixed effects for treatment, each scheduled time point (5 levels: weeks 2, 4, 6, 9, and 12), the treatment-by-time point interaction, and the DRA status. Baseline AIMS score was a covariate. The unstructured covariance model was used, and the primary analysis compared the SD-809 and placebo groups at week 12. This was based on the F-test using the Satterhwaite method to compute the denominator degrees of freedom.||-0.2|-2.6|0.0188
71829652|NCT01930045|143163464|SUPERIORITY_OR_OTHER||GMR|0.81|||||TWO_SIDED|90.0|0.63|1.05|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.05|0.63|
71720601|NCT02195700|142957041|SUPERIORITY||Differences in %|7.9||||0.4001|TWO_SIDED|95.0|-10.2|25.2||5% level of significance (2-sided)|Pearson's chi-square test|||The secondary efficacy endpoints were analyzed using a hierarchical testing procedure. If the primary analysis was statistically significant (p\<0.05), then the first key secondary endpoint was to be analyzed. If the first key secondary endpoint was statistically significant, then the second key secondary endpoint was to be similarly analyzed. For any analysis that was not statistically significant, all subsequent analyses of key secondary endpoints were exploratory rather than confirmatory.||25.2|-10.2|0.4001
71720602|NCT03980743|142957053|SUPERIORITY|||||||0.97|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24)||||0.97
71769119|NCT01551420|143038335|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0319|TWO_SIDED|95.0|-0.25|-0.01|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.01|-0.25|0.0319
71769120|NCT01551420|143038335|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0073|TWO_SIDED|95.0|-0.24|-0.04|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||-0.04|-0.24|0.0073
71769121|NCT01551420|143038336|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_DEVIATION|0.52||0.6529|TWO_SIDED|95.0|-0.24|0.15|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).||0.15|-0.24|0.6529
71769122|NCT01551420|143038336|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.64||0.849|TWO_SIDED|95.0|-0.26|0.22|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).||0.22|-0.26|0.8490
71769123|NCT01551420|143038336|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.17||0.4589|TWO_SIDED|95.0|-0.22|0.48|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.48|-0.22|0.4589
71769124|NCT01551420|143038336|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.18||0.711|TWO_SIDED|95.0|-0.31|0.44|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||0.44|-0.31|0.7110
71769125|NCT01551420|143038337|SUPERIORITY||Mean Difference (Net)|253.6|STANDARD_DEVIATION|325.2|<|0.0001|TWO_SIDED|95.0|146.7|360.5|||t-test, 2 sided|The sample for this paired t-test was 38 participants.||Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).|Mean difference is the change in scores from Baseline to End of A.|360.5|146.7|<0.0001
71769126|NCT01551420|143038337|SUPERIORITY||Slope|-183.1|STANDARD_ERROR_OF_MEAN|186.9||0.3397|TWO_SIDED|95.0|-574.3|208.2|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||208.2|-574.3|0.3397
71829653|NCT01930045|143163464|SUPERIORITY_OR_OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.5|0.92|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||0.92|0.50|
71720603|NCT03980743|142957054|SUPERIORITY|||||||0.273|||||||Mixed Models Analysis|||Time x treatment (week 0 and week 24) for Healthy Eating||||0.273
71720604|NCT03980743|142957055|SUPERIORITY|Time x treatment (week 0 and week 24) with sum score||||||0.691|||||||Mixed Models Analysis|||||||0.691
71720605|NCT02263326|142957073|NON_INFERIORITY|We considered DTG/3TC was noninferior to cART if the 90% confidence interval for the difference in proportions, calculated with Miettinen-Nurminen (score) confidence limits, excluded the 12% noninferiority margin.|Risk Difference (RD)|0.0015|||||TWO_SIDED|90.0|-0.098|0.102||||||A sample size of 41 participants per arm provided 80% power to show noninferiority of DTG/3TC to cART based on a 12% noninferiority margin, assuming an estimated treatment failure rate of 5% per arm by week 24 and 5% 1-sided type I error rate.||0.102|-0.098|
71720606|NCT02263326|142957074|NON_INFERIORITY|The difference in virologic outcomes based on the FDA snapshot algorithm at week 48 (HIV RNA \<50 copies/mL) was compared between arms, with 95% confidence intervals.|Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.126|0.165||||||||0.165|-0.126|
71829654|NCT01930045|143163465|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.55|1.1|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.10|0.55|
71829655|NCT01930045|143163465|SUPERIORITY_OR_OTHER||GMR|0.7|||||TWO_SIDED|90.0|0.48|1.04|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.04|0.48|
71720607|NCT02263326|142957075|OTHER|||||||0.866|||||||Wilcoxon (Mann-Whitney)|||||||0.866
71720608|NCT02263326|142957076|OTHER|||||||0.613|||||||Wilcoxon (Mann-Whitney)|||||||0.613
71720609|NCT02263326|142957077|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
71720610|NCT02263326|142957078|OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
71720611|NCT02263326|142957080|OTHER||Mean Difference (Final Values)|0.5||||0.76|TWO_SIDED|95.0|-3.0|4.1|||Regression, Linear|||||4.1|-3.0|0.76
71720612|NCT02397915|142957081|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71720613|NCT02397915|142957082|SUPERIORITY_OR_OTHER|||||||0.065||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute scent/odor.|Cochran-Mantel-Haenszel|||||||0.065
71720614|NCT02397915|142957082|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute immediate taste.|Cochran-Mantel-Haenszel|||||||0.532
71720615|NCT02397915|142957082|SUPERIORITY_OR_OTHER|||||||0.138||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute after taste.|Cochran-Mantel-Haenszel|||||||0.138
71720616|NCT02397915|142957082|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LDTT.|Cochran-Mantel-Haenszel|||||||<0.001
71720617|NCT02397915|142957082|SUPERIORITY_OR_OTHER|||||||0.017||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute LRON.|Cochran-Mantel-Haenszel|||||||0.017
71720618|NCT02397915|142957082|SUPERIORITY_OR_OTHER|||||||0.046||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute more soothing.|Cochran-Mantel-Haenszel|||||||0.046
71720619|NCT02397915|142957082|SUPERIORITY_OR_OTHER||||||<|0.001||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute less irritating.|Cochran-Mantel-Haenszel|||||||<0.001
71720620|NCT02397915|142957082|SUPERIORITY_OR_OTHER|||||||0.532||||||Par. preferences were analyzed using Prescott's test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg's method. P-value is for product attribute UTS.|Cochran-Mantel-Haenszel|||||||0.532
71720621|NCT02397915|142957083|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
71720622|NCT02397915|142957084|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
71720623|NCT02397915|142957085|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
71720624|NCT02397915|142957086|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.179||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.179
71720625|NCT02397915|142957087|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.00
71720626|NCT02397915|142957088|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71720627|NCT02397915|142957089|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71769127|NCT01551420|143038338|SUPERIORITY||Mean Difference (Net)|4.3|STANDARD_DEVIATION|10.01||0.0465|TWO_SIDED|95.0|0.07|8.53|||t-test, 2 sided|The sample for this paired t-test was 24 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).||8.53|0.07|0.0465
71829656|NCT01930045|143163466|SUPERIORITY_OR_OTHER||GMR|0.5|||||TWO_SIDED|90.0|0.39|0.65|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.65|0.39|
71829657|NCT01930045|143163466|SUPERIORITY_OR_OTHER||GMR|0.51|||||TWO_SIDED|90.0|0.4|0.64|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4||0.64|0.40|
71829658|NCT01930045|143163467|SUPERIORITY_OR_OTHER||GMR|0.87|||||TWO_SIDED|90.0|0.64|1.18|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.18|0.64|
71720628|NCT02397915|142957090|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||1.000
71720629|NCT02397915|142957091|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.188||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.188
71720630|NCT02397915|142957092|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71720631|NCT02397915|142957093|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71720632|NCT02397915|142957094|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71720633|NCT02397915|142957095|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.004||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.004
71720634|NCT02397915|142957096|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.223||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.223
71720635|NCT02397915|142957097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71720636|NCT02397915|142957098|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.008||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.008
71720637|NCT02397915|142957099|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.831||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.831
71720638|NCT02397915|142957100|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||<0.001
71720639|NCT02397915|142957101|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.007||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.007
71720640|NCT02397915|142957102|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.568||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.568
71720641|NCT02397915|142957103|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg's method.|Cochran-Mantel-Haenszel|||||||0.951
71720642|NCT04551963|142957208|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.42|0.56||||||Arm A: Zanubrutinib alone vs. Zanubrutinib + fluconazole||0.56|0.42|
71720643|NCT04551963|142957208|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.42|||||TWO_SIDED|90.0|0.34|0.51||||||Arm a: Zanubrutinib alone vs. Zanubrutinib + diltiazem||0.51|0.34|
71720644|NCT04551963|142957209|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||0.99|0.66|
71720645|NCT04551963|142957209|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.49|||||TWO_SIDED|90.0|0.41|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.41|
71720646|NCT04551963|142957210|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||1.08|0.82|
71829659|NCT01930045|143163467|SUPERIORITY_OR_OTHER||GMR|0.89|||||TWO_SIDED|90.0|0.64|1.22|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.22|0.64|
71720647|NCT04551963|142957210|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.81|||||TWO_SIDED|90.0|0.66|0.99||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.99|0.66|
71720648|NCT04551963|142957211|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.83|||||TWO_SIDED|90.0|0.65|1.06||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.06|0.65|
71720649|NCT04551963|142957211|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.48|||||TWO_SIDED|90.0|0.4|0.58||||||Arm B: Zanubrutinib alone vs zanubrutinib + clarithromycin||0.58|0.40|
71720650|NCT04551963|142957212|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.45|||||TWO_SIDED|90.0|0.35|0.58||||||Arm A: Zanubrutinib alone vs. zanubrutinib + fluconazole||0.58|0.35|
71720651|NCT04551963|142957212|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.41|||||TWO_SIDED|90.0|0.32|0.51||||||Arm A: Zanubrutinib alone vs. zanubrutinib + diltiazem||0.51|0.32|
71720652|NCT04551963|142957213|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.82|||||TWO_SIDED|90.0|0.68|1.0||||||Arm B: Zanubrutinib alone vs. zanubrutinib + voriconazole||1.00|0.68|
71720653|NCT04551963|142957213|EQUIVALENCE|Two one sided tests procedure by estimation of ratio of geometric means and 90% CI; exponential transformation from estimated difference in natural logarithm scale obtained from linear mixed effect model with treatment as a fixed effect and participant as a random effect.|Ratio of geometric least squares mean|0.5|||||TWO_SIDED|90.0|0.39|0.64||||||Arm B: Zanubrutinib alone vs. zanubrutinib + clarithromycin||0.64|0.39|
71720654|NCT00700622|142957238|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|-0.31|0.17|||ANCOVA|||||0.17|-0.31|
71720655|NCT01204905|142957278|OTHER|This was a pilot study with a small sample population. There were no power calculations performed.|||||||||||||||||The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.|||
71720656|NCT01204905|142957279|OTHER|There were no power calculations performed due to the size of the pilot study.|||||||||||||||||Number of weeks to virologic suppression|||
71720657|NCT02526212|142957282|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Due to the small sample size, planned analyses that assessed for clustering by group assignment or primary care physician could not be conducted. Chi square using fisher's exact test was conducted to investigate differences in abstinence between study arms.||||0.44
71720658|NCT02526212|142957285|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Each of the 17 items were rated on a scale from 1 to 5. For each participant, the scores from these items were summed and divided by 17 for an average satisfaction score. The average satisfaction score was compared between study arms.||||0.20
71720659|NCT03645096|142957288|SUPERIORITY||Mean Difference (Final Values)|0.0493|STANDARD_ERROR_OF_MEAN|0.0554||0.195|TWO_SIDED|95.0|-0.0703|0.1689||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1689|-0.0703|.195
71720660|NCT03645096|142957288|SUPERIORITY||Mean Difference (Final Values)|0.0262|STANDARD_ERROR_OF_MEAN|0.0565||0.325|TWO_SIDED|95.0|-0.0943|0.1467||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Amygdala-PCC functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1467|-0.0943|.325
71720661|NCT03645096|142957289|SUPERIORITY||Mean Difference (Final Values)|-0.0071|STANDARD_ERROR_OF_MEAN|0.0878||0.468|TWO_SIDED|95.0|-0.1969|0.1827||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 500 mg will be greater than that at placebo."||0.1827|-0.1969|.468
71720662|NCT03645096|142957289|SUPERIORITY||Mean Difference (Final Values)|0.0097|STANDARD_ERROR_OF_MEAN|0.0891||0.458|TWO_SIDED|95.0|-0.1803|0.1996||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: dlPFC-Insula functional connectivity (z-score) at 800 mg will be greater than that at placebo."||0.1996|-0.1803|.458
71829660|NCT01930045|143163468|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.4|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.40|0.58|
71720663|NCT03645096|142957290|SUPERIORITY||Mean Difference (Final Values)|0.0038|STANDARD_ERROR_OF_MEAN|0.0078||0.316|TWO_SIDED|95.0|-0.0132|0.0209||Paired samples t-test with corrected standard deviation of the difference.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0209|-0.0132|.316
71720664|NCT03645096|142957290|SUPERIORITY||Mean Difference (Final Values)|0.0131|STANDARD_ERROR_OF_MEAN|0.0084||0.071|TWO_SIDED|95.0|-0.005|0.0312||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: GABA concentration (mM) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: GABA concentration (mM) at 500 mg will be greater than that at placebo."||0.0312|-0.0050|.071
71720665|NCT03645096|142957291|SUPERIORITY||Mean Difference (Final Values)|-11322.45|STANDARD_ERROR_OF_MEAN|3750.52||0.006|TWO_SIDED|95.0|-19577.27|-3067.62||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 500 mg will be greater than that at placebo."||-3067.62|-19577.27|.006
71720666|NCT03645096|142957291|SUPERIORITY||Mean Difference (Final Values)|-11828.78|STANDARD_ERROR_OF_MEAN|3620.42||0.003|TWO_SIDED|95.0|-19650.24|-4007.33||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Pregnenolone level (pg/mL) at 800 mg will be greater than that at placebo."||-4007.33|-19650.24|.003
71720667|NCT03645096|142957292|SUPERIORITY||Mean Difference (Final Values)|-2523.58|STANDARD_ERROR_OF_MEAN|545.83||0.001|TWO_SIDED|95.0|-3724.93|-1322.22||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 500 mg will be greater than that at placebo."||-1322.22|-3724.93|.001
71720668|NCT03645096|142957292|SUPERIORITY||Mean Difference (Final Values)|-2480.62|STANDARD_ERROR_OF_MEAN|582.63||0.001|TWO_SIDED|95.0|-3739.32|-1221.93||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be less than or equal to that at placebo.~Alternative Hypothesis: Allopregnanolone level (pg/mL) at 800 mg will be greater than that at placebo."||-1221.93|-3739.32|.001
71720669|NCT03645096|142957293|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|0.7059|STANDARD_ERROR_OF_MEAN|1.6377||0.336|TWO_SIDED|95.0|-2.7659|4.1777||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (500 mg)|"Null Hypothesis: SAFTEE (total) scores at 500 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 500 mg will be less than that at placebo."||4.1777|-2.7659|.336
71720670|NCT03645096|142957293|NON_INFERIORITY|"Using the two one-sided test (TOST) procedure (Schuirmann, 1987), equivalence is established at the α significance level if a (1-2α) × 100% confidence interval for the difference in efficacies (new - current) is contained within the interval (-δ, δ)~Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. Journal of pharmacokinetics and biopharmaceutics, 15, 657-680."|Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|3.4662||0.24|TWO_SIDED|95.0|-9.8131|4.8131||Statistical significance is evaluated at p (one-tailed) \<= .05.|t-test, 1 sided|Paired samples t-test with corrected standard deviation of the difference.|Mean Difference = placebo - pregnenolone (800 mg)|"Null Hypothesis: SAFTEE (total) scores at 800 mg will be greater than or equal to that at placebo.~Alternative Hypothesis: SAFTEE (total) scores at 800 mg will be less than that at placebo."||4.8131|-9.8131|.240
71720671|NCT00040742|142957295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.566|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||.017
71720672|NCT00040742|142957295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506|STANDARD_ERROR_OF_MEAN|0.141||0.036|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.036
71829661|NCT01930045|143163468|SUPERIORITY_OR_OTHER||GMR|0.9|||||TWO_SIDED|90.0|0.58|1.41|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|||1.41|0.58|
71829662|NCT03034915|143163478|OTHER||Mean Difference (Net)|0.066|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.043|0.089|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.089|0.043|<0.001
71720673|NCT00040742|142957295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.269|STANDARD_ERROR_OF_MEAN|0.137||0.431|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.431
71720674|NCT00040742|142957295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.16||0.003|TWO_SIDED||||||Mixed Models Analysis|Parameter estimated using a contrast.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs. Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)"||||0.003
71720675|NCT00040742|142957296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.127||0.046|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.046
71720676|NCT00040742|142957296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.124||0.076|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.076
71720677|NCT00040742|142957296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.12||0.738|TWO_SIDED|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.738
71720678|NCT00040742|142957296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.013|TWO_SIDED||||||Mixed Models Analysis|Contrasts used for estimation.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)"||||0.013
71720679|NCT00405392|142957319|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71720680|NCT00405392|142957320|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71720681|NCT00405392|142957321|SUPERIORITY_OR_OTHER|||||||0.9456|||||||t-test, 2 sided|||||||0.9456
71720682|NCT04904744|142957335|SUPERIORITY||Odds Ratio (OR)|1.35||||0.165|TWO_SIDED|95.0|0.88|2.06|||Regression, Logistic||Low Tailored Message vs. No Message (reference group)|||2.06|0.88|0.165
71720683|NCT04904744|142957335|SUPERIORITY||Odds Ratio (OR)|1.33||||0.193|TWO_SIDED|95.0|0.87|2.03|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.03|0.87|0.193
71720684|NCT04904744|142957335|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.68|1.52|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||1.52|0.68|0.930
71720685|NCT04904744|142957336|SUPERIORITY||Odds Ratio (OR)|2.07||||0.008|TWO_SIDED|95.0|1.21|3.52|||Regression, Logistic||Low Tailored Message vs. No Message|||3.52|1.21|0.008
71829663|NCT03034915|143163478|OTHER||Mean Difference (Net)|0.141|STANDARD_ERROR_OF_MEAN|0.0117|<|0.001|TWO_SIDED|95.0|0.118|0.164|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.164|0.118|<0.001
71829664|NCT03034915|143163478|OTHER||Mean Difference (Net)|0.075|STANDARD_ERROR_OF_MEAN|0.0119|<|0.001|TWO_SIDED|95.0|0.051|0.098|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.098|0.051|<0.001
71829665|NCT03034915|143163479|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.157||0.018|TWO_SIDED|95.0|0.06|0.68|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.68|0.06|0.018
71829666|NCT03034915|143163479|OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.155||0.004|TWO_SIDED|95.0|0.15|0.76|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.76|0.15|0.004
71720686|NCT04904744|142957336|SUPERIORITY||Odds Ratio (OR)|1.25||||0.457|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||2.23|0.70|0.457
71720687|NCT04904744|142957336|SUPERIORITY||Odds Ratio (OR)|1.66||||0.049|TWO_SIDED|95.0|1.0|2.74|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||2.74|1.00|0.049
71720688|NCT04904744|142957337|SUPERIORITY||Odds Ratio (OR)|2.04||||0.104|TWO_SIDED|95.0|0.86|4.82|||Regression, Logistic||Low Tailored Message vs. No Message|||4.82|0.86|0.104
71720689|NCT04904744|142957337|SUPERIORITY||Odds Ratio (OR)|1.26||||0.631|TWO_SIDED|95.0|0.49|3.22|||Regression, Logistic||Low tailored message plus COVID-19 vaccine message vs. No Message|||3.22|0.49|0.631
71720690|NCT04904744|142957337|SUPERIORITY||Odds Ratio (OR)|1.62||||0.238|TWO_SIDED|95.0|0.73|3.61|||Regression, Logistic||Low Tailored Message vs. Low tailored message plus COVID-19 vaccine message|||3.61|0.73|0.238
71720691|NCT02550288|142957339|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-36.3|||<|0.001|TWO_SIDED|95.0|-40.5|-32.2|||Constrained longitudinal data analysis|||||-32.2|-40.5|<0.001
71720692|NCT02550288|142957339|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.6|||<|0.001|TWO_SIDED|95.0|-14.9|-8.2|||Constrained longitudinal data analysis|||||-8.2|-14.9|<0.001
71720693|NCT02550288|142957339|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-39.9|||<|0.001|TWO_SIDED|95.0|-44.1|-35.8|||Constrained longitudinal data analysis|||||-35.8|-44.1|<0.001
71720694|NCT02550288|142957339|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.1|||<|0.001|TWO_SIDED|95.0|-13.5|-6.8|||Constrained longitudinal data analysis|||||-6.8|-13.5|<0.001
71720695|NCT02819297|142957357|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71829667|NCT03034915|143163479|OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.159||0.61|TWO_SIDED|95.0|-0.23|0.39|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24|||0.39|-0.23|0.610
71829668|NCT03034915|143163480|OTHER||Odds Ratio (OR)|1.43|||<|0.001|TWO_SIDED|95.0|1.17|1.75|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 24|||1.75|1.17|<0.001
71720696|NCT03928418|142957377|SUPERIORITY||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.1|4.9||p-value comparing live call booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||4.9|2.1|<0.001
71829669|NCT03034915|143163480|OTHER||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.21|1.81|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24|||1.81|1.21|<0.001
71720697|NCT03928418|142957377|SUPERIORITY||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|2.2|5.1||p-value comparing technology booster to SOC arm: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||5.1|2.2|<0.001
71720698|NCT03928418|142957378|SUPERIORITY||Mean Difference (Net)|36.4||||0.643|TWO_SIDED|95.0|-117.5|190.3||p-value comparing live call booster arm to SOC arm: p = 0.643|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm reported here.|||190.3|-117.5|0.643
71720699|NCT03928418|142957378|SUPERIORITY||Mean Difference (Net)|-30.9||||0.711|TWO_SIDED|95.0|-194.8|132.9||p-value comparing technology booster arm to SOC arm: p = 0.711|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm reported here.|||132.9|-194.8|0.711
71720700|NCT03928418|142957379|SUPERIORITY||Mean Difference (Net)|-2.3||||0.515|TWO_SIDED|95.0|-9.3|4.7||p-value comparing live call booster arm to SOC: p = 0.515|Regression, Logistic||SOC minus live call booster arm presented here.|||4.7|-9.3|0.515
71720701|NCT03928418|142957379|SUPERIORITY||Mean Difference (Net)|-0.9||||0.801|TWO_SIDED|95.0|-8.3|6.4||p-value comparing technology booster arm to SOC: p = 0.801|Regression, Logistic||SOC minus technology booster arm presented here.|||6.4|-8.3|0.801
71720702|NCT03928418|142957380|SUPERIORITY||Mean Difference (Net)|28.9|||<|0.001|TWO_SIDED|95.0|17.0|40.7||p-value comparing live call booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||40.7|17.0|<0.001
71720703|NCT03928418|142957380|SUPERIORITY||Mean Difference (Net)|24.9|||<|0.001|TWO_SIDED|95.0|13.0|36.8||p-value comparing technology booster arm to SOC: p \< 0.001 (calculated)|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||36.8|13.0|<0.001
71720704|NCT03928418|142957381|SUPERIORITY||Mean Difference (Net)|4.4||||0.002|TWO_SIDED|95.0|1.6|7.3||p-value comparing live call booster arm to SOC: p = 0.002|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus live call booster arm presented here.|||7.3|1.6|0.002
71720705|NCT03928418|142957381|SUPERIORITY||Mean Difference (Net)|4.3||||0.003|TWO_SIDED|95.0|1.5|7.2||p-value comparing technology booster arm to SOC: p = 0.003|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm|SOC arm minus technology booster arm presented here.|||7.2|1.5|0.003
71829670|NCT03034915|143163480|OTHER||Odds Ratio (OR)|1.03||||0.755|TWO_SIDED|95.0|0.84|1.27|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.27|0.84|0.755
71829671|NCT03034915|143163481|OTHER||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.213||0.013|TWO_SIDED|95.0|-0.95|-0.11|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.11|-0.95|0.013
71829672|NCT03034915|143163481|OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.211|<|0.001|TWO_SIDED|95.0|-1.25|-0.42|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24..|||-0.42|-1.25|<0.001
71720706|NCT03928418|142957383|SUPERIORITY||Mean Difference (Net)|-0.8||||0.61|TWO_SIDED|95.0|-3.8|2.2||p-value comparing live call booster arm to SOC arm: p = 0.610.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus live call booster arm presented here.|||2.2|-3.8|0.610
71720707|NCT03928418|142957383|SUPERIORITY||Mean Difference (Net)|-1.1||||0.474|TWO_SIDED|95.0|-4.1|1.9||p-value comparing technology booster arm to SOC arm: p = 0.474.|Mixed Models Analysis|Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm|SOC minus technology booster arm presented here.|||1.9|-4.1|0.474
71829673|NCT03034915|143163481|OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.214||0.159|TWO_SIDED|95.0|-0.72|0.12|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24|||0.12|-0.72|0.159
71720708|NCT00763256|142957390|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71720709|NCT00763256|142957391|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71720710|NCT00763256|142957392|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71720711|NCT00763256|142957393|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71720712|NCT00763256|142957394|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71720713|NCT00244725|142957411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45||||0.012|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.012
71720714|NCT00244725|142957411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.42||||0.017|TWO_SIDED|95.0|1.1|1.9|||Fisher Exact|||||1.9|1.1|0.017
71720715|NCT00244725|142957411|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.32||||0.08|TWO_SIDED|95.0|1.0|1.8|||Fisher Exact|||||1.8|1.0|0.080
71720716|NCT01625416|142957474|SUPERIORITY|||||||0.05|||||||Chi-squared|Chi square (2) =5.9, p=0.05|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.05
71720717|NCT01625416|142957475|SUPERIORITY|||||||0.69|||||||Chi-squared|Chi square(2) = 0.74, p = 0.69|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.69
71720718|NCT01625416|142957478|SUPERIORITY|||||||0.97||||||Chi square (2) = 0.06, p = 0.97|Chi-squared||||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.97
71720719|NCT01625416|142957479|SUPERIORITY|||||||0.71|||||||Chi-squared|Chi-Square (2) =0.68, p=0.71|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.|||0.71
71829674|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.114||0.016|TWO_SIDED|95.0|-0.5|-0.05||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||-0.05|-0.50|0.016
71720720|NCT02311881|142957504|SUPERIORITY_OR_OTHER||LS mean difference|-2.51||||0.1626|TWO_SIDED|95.0|-6.037|1.016|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo."||1.016|-6.037|0.1626
71720721|NCT02311881|142957504|NON_INFERIORITY_OR_EQUIVALENCE|Paracetamol 2000mg BID is non-inferior to Paracetamol 1330mg TID if the upper bound of the 95% confidence Interval is less than 5.3.|LS mean difference|-2.36|||||TWO_SIDED|95.0|-5.894|1.166|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is ≤ - 5.3 (inferiority).~H1: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is \> - 5.3 (noninferiority)."||1.166|-5.894|
71720722|NCT02311881|142957504|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.9352|TWO_SIDED|95.0|-3.687|3.394|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo."||3.394|-3.687|0.9352
71720723|NCT00819156|142957514|SUPERIORITY_OR_OTHER_LEGACY||Percentage|61.0||||||95.0|41.0|78.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||78|41|
71720724|NCT00819156|142957514|SUPERIORITY_OR_OTHER_LEGACY||Percentage|84.0||||||95.0|64.0|95.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||95|64|
71720725|NCT00819156|142957514|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|81.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|81|
71720726|NCT00819156|142957514|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
71829675|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-0.68|-0.23||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.23|-0.68|<0.001
71829676|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.115||0.115|TWO_SIDED|95.0|-0.41|0.04||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.04|-0.41|0.115
71720727|NCT00819156|142957514|SUPERIORITY_OR_OTHER_LEGACY||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|73|
71720728|NCT00819156|142957514|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|74.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||99|74|
71720729|NCT00819156|142957515|SUPERIORITY_OR_OTHER_LEGACY||Percentage|92.0||||||95.0|80.0|98.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||98|80|
71720730|NCT00819156|142957515|SUPERIORITY_OR_OTHER_LEGACY||Percentage|96.0||||||95.0|86.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|86|
71720731|NCT00819156|142957515|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0||||||95.0|93.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) \<=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T \<=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.|||100|93|
71720732|NCT00819156|142957516|SUPERIORITY_OR_OTHER_LEGACY||Percentage|70.0||||||95.0|51.0|85.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||85|51|
71720733|NCT00819156|142957516|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|75.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|75|
71720734|NCT00819156|142957516|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|84.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|84|
71720735|NCT00819156|142957516|SUPERIORITY_OR_OTHER_LEGACY||Percentage|97.0||||||95.0|83.0|100.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||100|83|
71720736|NCT00819156|142957516|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|80.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|80|
71720737|NCT00819156|142957516|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|77.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|77|
71720738|NCT00819156|142957517|SUPERIORITY_OR_OTHER_LEGACY||Percentage|83.0||||||95.0|65.0|94.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||94|65|
71720739|NCT00819156|142957517|SUPERIORITY_OR_OTHER_LEGACY||Percentage|94.0||||||95.0|79.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|79|
71720740|NCT00819156|142957517|SUPERIORITY_OR_OTHER_LEGACY||Percentage|87.0||||||95.0|70.0|96.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||96|70|
71720741|NCT00819156|142957517|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
71720742|NCT00819156|142957517|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0||||||95.0|76.0|98.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||98|76|
71720743|NCT00819156|142957517|SUPERIORITY_OR_OTHER_LEGACY||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone \<=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.|||99|78|
71720744|NCT00819156|142957518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933||95.0|||||Log Rank|||||||0.0933
71720745|NCT00819156|142957519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165||95.0|||||Log Rank|||||||0.165
71720746|NCT00819156|142957520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.429||95.0|||||Log Rank|||||||0.429
71720747|NCT01575808|142957537|SUPERIORITY_OR_OTHER_LEGACY||Percentage|91.0|||<|0.0001|ONE_SIDED|95.0|86.3||||z-test|One-sided z-test||A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.|||86.3|<0.0001
71720748|NCT01575808|142957538|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.||||<0.0001
71720749|NCT01575808|142957539|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||<|0.0001|TWO_SIDED|95.0|96.5|100.0|||Fisher Exact||Confidence interval calculated with binomial exact method.|The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.||100|96.5|<0.0001
71720750|NCT01575808|142957540|SUPERIORITY_OR_OTHER_LEGACY||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence intervals calculated using the binomial exact method.|||100.0|96.5|
71720751|NCT01575808|142957570|OTHER||Percentage|97.1|||||TWO_SIDED|95.0|91.7|99.4||||||||99.4|91.7|
71720752|NCT01575808|142957590|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|96.5|100.0|||||Confidence Interval calculated with binomial exact method.|||100.0|96.5|
71720753|NCT03292874|142957632|SUPERIORITY|||||||0.014||||||"Areas under the receiver operating characteristics curve (AUC) were compared between models with standard and high-resolution MRI variables using the nonparametric method described by DeLong.~DeLong. Biometrics 1988;44(3):837-45."|nonparametric method|||||||0.014
71720754|NCT00485758|142957645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-21.4|-14.4|||Wilcoxon (Mann-Whitney)|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.||||-14.4|-21.4|<0.001
71769128|NCT01551420|143038338|SUPERIORITY||Slope|-2.39|STANDARD_ERROR_OF_MEAN|2.46||0.345|TWO_SIDED|95.0|-7.6|2.82|||Regression, Linear|The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||2.82|-7.60|0.3450
71720755|NCT00485758|142957646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|20.7|25.7|||Repeated Measures Analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.||||25.7|20.7|<0.001
71720756|NCT00485758|142957647|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.1|||<|0.001||95.0|-27.2|-18.9|||ANCOVA|Nonparametric Analysis of Covariance model based on Tukey's normalized ranks with term for treatment, gender and Tukey's normal score of baseline.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon's rank|||-18.9|-27.2|<0.001
71720757|NCT00654745|142957648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001|TWO_SIDED|95.0|-21.5|-18.4|||t-test, 2 sided|||||-18.4|-21.5|<0.0001
71720758|NCT00654745|142957649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.2|-10.3||24-hour mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.3|-12.2|<0.0001
71720759|NCT00654745|142957649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.5||daytime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.5|-12.9|<0.0001
71720760|NCT00654745|142957649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.0||nighttime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.0|-11.7|<0.0001
71720761|NCT00654745|142957649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.9|||<|0.0001|TWO_SIDED|95.0|-12.2|-9.7||last 6 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.7|-12.2|<0.0001
71720762|NCT00654745|142957649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8||last 4 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.8|-12.4|<0.0001
71720763|NCT00654745|142957649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|||<|0.0001|TWO_SIDED|95.0|-13.1|-10.0||last 2 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-10.0|-13.1|<0.0001
71720764|NCT00654745|142957650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-18.9||daytime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-18.9|-22.6|<0.0001
71769129|NCT01551420|143038339|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_DEVIATION|7.54||0.6881|TWO_SIDED|95.0|-1.86|2.79|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).||2.79|-1.86|0.6881
71829677|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.063||0.247|TWO_SIDED|95.0|-0.2|0.05||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.|||0.05|-0.20|0.247
71829678|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.063||0.042|TWO_SIDED|95.0|-0.25|0.0||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||0.00|-0.25|0.042
71829679|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.063||0.391|TWO_SIDED|95.0|-0.18|0.07||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.18|0.391
71720765|NCT00654745|142957650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.5|||<|0.0001|TWO_SIDED|95.0|-20.4|-16.6||nighttime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.6|-20.4|<0.0001
71720766|NCT00654745|142957650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.9|||<|0.0001|TWO_SIDED|95.0|-20.7|-17.0||last 6 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.0|-20.7|<0.0001
71720767|NCT00654745|142957650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.1|||<|0.0001|TWO_SIDED|95.0|-21.1|-17.1||last 4 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.1|-21.1|<0.0001
71720768|NCT00654745|142957650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.5|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4||last 2 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.4|-21.7|<0.0001
71720769|NCT00654745|142957651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|||<|0.0001|TWO_SIDED|95.0|-12.0|-8.6||Change in mean seated systolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.6|-12.0|<0.0001
71720770|NCT00654745|142957651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.8|-16.1||Change in mean seated systolic blood pressure from baseline to week 6.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-16.1|-19.8|<0.0001
71720771|NCT00654745|142957651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-22.2|-17.8||Change in mean seated systolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-17.8|-22.2|<0.0001
71720772|NCT00654745|142957651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.7|||<|0.0001|TWO_SIDED|95.0|-25.7|-21.7||Change in mean seated systolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-21.7|-25.7|<0.0001
71720773|NCT00654745|142957651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.5|||<|0.0001|TWO_SIDED|95.0|-30.8|-26.2||Change in mean seated systolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-26.2|-30.8|<0.0001
71720774|NCT00654745|142957651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.1|||<|0.0001|TWO_SIDED|95.0|-33.3|-28.8||Change in mean seated systolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-28.8|-33.3|<0.0001
71720775|NCT00654745|142957652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.1||Change in mean seated diastolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-3.1|-5.1|<0.0001
71720776|NCT00654745|142957652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.2|||<|0.0001|TWO_SIDED|95.0|-9.4|-7.1||Change in mean seated diastolic blood pressure from baseline to week 6|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-7.1|-9.4|<0.0001
71720777|NCT00654745|142957652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7|||<|0.0001|TWO_SIDED|95.0|-10.9|-8.4||Change in mean seated diastolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-8.4|-10.9|<0.0001
71829680|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.31|-0.04||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24|||-0.04|-0.31|0.014
71829681|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.37|-0.1||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comapring UMEC/VI versus salmeterol at Week 21 to Week 24.|||-0.10|-0.37|<0.001
71829682|NCT03034915|143163482|OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.34|TWO_SIDED|95.0|-0.2|0.07||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.|||0.07|-0.20|0.340
71829683|NCT03034915|143163483|OTHER||Odds Ratio (OR)|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 21 to Week 24|||1.89|1.22|<0.001
71829684|NCT03034915|143163483|OTHER||Odds Ratio (OR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.9|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 21 to Week 24.|||1.90|1.23|<0.001
71829685|NCT03034915|143163483|OTHER||Odds Ratio (OR)|1.0||||0.969|TWO_SIDED|95.0|0.8|1.26|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 21 to Week 24.|||1.26|0.80|0.969
71829686|NCT03034915|143163484|OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.672||0.709|TWO_SIDED|95.0|-1.07|1.57|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||1.57|-1.07|0.709
71829687|NCT03034915|143163484|OTHER||Mean Difference (Net)|-1.69|STANDARD_ERROR_OF_MEAN|0.665||0.011|TWO_SIDED|95.0|-2.99|-0.39|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||-0.39|-2.99|0.011
71887491|NCT02167945|143295848|SUPERIORITY||Cox Proportional Hazard Ratio|0.133|||<|0.001|TWO_SIDED|95.0|0.057|0.313|||Cox proportional hazards model||The estimated value represents the hazard ratio for developing the event in the group of participants in studies M14-222 and M14-423 who achieved SVR12 compared to the group of participants in studies M14-222 and M14-423 who didn't achieve SVR12.|A Cox proportional hazards (PH) model was constructed. The covariates for the model included baseline age, BMI, HCV genotype 1 subtype (1b, non-1b), IL28B genotype (CC, non-CC), prior treatment history (naive, experienced), baseline HCV RNA levels, baseline fibrosis stage (F0-1, F2, F3, F4), baseline albumin, baseline creatinine clearance, baseline platelet count, history of diabetes (yes, no), APRI, race (white, other), and alcohol use status (current, former, non-drinker).||0.313|0.057|<0.001
71720778|NCT00654745|142957652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.0001|TWO_SIDED|95.0|-12.5|-9.9||Change in mean seated diastolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-9.9|-12.5|<0.0001
71720779|NCT00654745|142957652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-13.1||Change in mean seated diastolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.1|-15.7|<0.0001
71720780|NCT00654745|142957652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||<|0.0001|TWO_SIDED|95.0|-16.5|-13.6||Change in mean seated diastolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.||-13.6|-16.5|<0.0001
71720781|NCT00383331|142957682|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||The response rates are separately evaluated for these two treatment arms. For each arm, a sample size of 48 achieves 91% power to detect a difference of 20% between the null hypothesis of 15% response rate and the alternative hypothesis of 35% using a one-sided, binomial hypothesis test with a target significance level of 2.5% (the actual significance level is 2.2%).||||0.48
71720782|NCT00383331|142957687|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Log Rank|||||||0.56
71720783|NCT00924612|142957688|OTHER||Odds Ratio, log|130.83|STANDARD_ERROR_OF_MEAN|0.0844||0.0025|TWO_SIDED|90.0|113.59|150.7|||t-test, 2 sided|||Comparison of diets based on full crossover model|ANOVA of a multicenter, 4 sequence, 5 treatment crossover model using ln-transformed data. Normal fat diet compared to fasting, very low fat, low fat, and high fat diets as part of the overall analysis. No adjustments for multiplicity made.|150.70|113.59|0.0025
71720784|NCT00924612|142957688|OTHER||Odds Ratio, log|101.84|STANDARD_ERROR_OF_MEAN|0.0954||0.8494|TWO_SIDED|90.0|86.8|119.47|||t-test, 2 sided|||Comparison of diets based on full crossover model||119.47|86.80|0.8494
71720785|NCT00924612|142957688|OTHER||Odds Ratio, log|73.55|STANDARD_ERROR_OF_MEAN|0.0902||0.0013|TWO_SIDED|90.0|63.23|85.55|||t-test, 2 sided|||Comparison of diets based on full crossover model||85.55|63.23|0.0013
71720786|NCT00924612|142957688|OTHER||Odds Ratio, log|62.62|STANDARD_ERROR_OF_MEAN|0.0954|<|0.0001|TWO_SIDED|90.0|53.38|76.46|||t-test, 2 sided|||Comparison of diets based on full crossover model||76.46|53.38|<0.0001
71720787|NCT04852055|142957692|SUPERIORITY||average marginal effect|-2.8|||||TWO_SIDED|95.0|-6.1|0.5||||||||0.5|-6.1|
71829688|NCT03034915|143163484|OTHER||Mean Difference (Net)|-1.94|STANDARD_ERROR_OF_MEAN|0.678||0.004|TWO_SIDED|95.0|-3.27|-0.61|||mixed model repeated measure||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||-0.61|-3.27|0.004
71829689|NCT03034915|143163485|OTHER||Odds Ratio (OR)|1.21||||0.063|TWO_SIDED|95.0|0.99|1.48|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.48|0.99|0.063
71829690|NCT03034915|143163485|OTHER||Odds Ratio (OR)|1.49|||<|0.001|TWO_SIDED|95.0|1.22|1.83|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.83|1.22|<0.001
71829691|NCT03034915|143163485|OTHER||Odds Ratio (OR)|1.23||||0.045|TWO_SIDED|95.0|1.0|1.51|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.51|1.00|0.045
71829692|NCT03034915|143163486|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.891|TWO_SIDED|95.0|-0.6|0.6|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.|||0.6|-0.6|0.891
71829693|NCT03034915|143163486|OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.074|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.|||0.1|-1.1|0.074
71829694|NCT03034915|143163486|OTHER||Odds Ratio (OR)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.107|TWO_SIDED|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.|||0.1|-1.1|0.107
71720788|NCT04852055|142957693|SUPERIORITY||average marginal effect|-0.6|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
71720789|NCT02229825|142957696|OTHER|||||||0.88||||||p-value for treatment effect|ANCOVA|ANCOVA with stratification factors (country and pretreatment) and baseline score and treatment as the main factor.||The null hypothesis was that the mean change in MADRS total score between week 4 and baseline was the same for the 2 duloxetine treatment groups.||||0.88
71720790|NCT02229825|142957697|OTHER|||||||0.86||||||Treatment effect.|ANCOVA|Analysis of covariance (ANCOVA) with stratification factors and HAMD6 baseline as covariates and treatment regimen as main factor.||Comparison between treatment regimes at Week 4.||||0.86
71720791|NCT02229825|142957698|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparisons, week 8 versus baseline.||||<0.0001
71720792|NCT02229825|142957698|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720793|NCT02229825|142957698|OTHER||||||<|0.0001|||||||Singed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720794|NCT02229825|142957698|OTHER||||||<|0.0001|||||||Signed Rank test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720795|NCT02229825|142957700|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71720796|NCT02229825|142957700|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71720797|NCT02229825|142957700|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71720798|NCT02229825|142957700|OTHER||||||<|0.0001|||||||McNemar|||Within group comparisons were performed at week 8 versus baseline.||||<0.0001
71720799|NCT02229825|142957701|OTHER|||||||0.32||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.32
71720800|NCT02229825|142957703|OTHER|||||||0.57||||||Treatment effect.|Regression, Logistic|||Treatment groups were compared regarding the number of responders and non-responders at week 4, using a logistic regression with stratification factors (country and pretreatment) and baseline scores as covariates and treatment regimen as main factor.||||0.57
71720801|NCT02229825|142957706|OTHER|||||||0.68|||||||Cochran-Mantel-Haenszel|Stratified by country, 60 mg vs. 120 mg||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.68
71720802|NCT02229825|142957707|OTHER||Statistic|-528.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71720803|NCT02229825|142957707|OTHER||Statistic|-540.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71720804|NCT02229825|142957707|OTHER||Statistic|-1024.5|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71720805|NCT02229825|142957707|OTHER||Statistic|-279.0|||<|0.0001|||||||Signed Rank test||Difference is value at week 8 minus week 4.|At week 8, within-group comparison versus week 4 was performed.||||<0.0001
71720806|NCT02229825|142957708|OTHER|No formal hypothesis was tested.||||||0.07||||||Stratified by country, 60 mg vs. 120 mg|Cochran-Mantel-Haenszel|||"At week 4 CGI-S items were pooled to reduce the possible number of classes before formal testing. The 3 classes used (instead of 7 items) were: 1-2: normal, 3-5: moderate, 6-7: severe. Treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||0.07
71720807|NCT02229825|142957710|OTHER||CMH statistic|0.0||||1|||||||Cochran-Mantel-Haenszel|||"Before testing, PGI-I items were pooled to reduce the possible number of classes. The 3 classes used (instead of 7 items) were: 1-2= improved, 3-5=Stable, 6-7=Worsened. At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre."||||1.00
71720808|NCT02229825|142957712|OTHER|||||||0.92||||||Treatment effect|ANCOVA|||Comparison between HAMA scores between treatment regimens.||||0.92
71720809|NCT02229825|142957713|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720810|NCT02229825|142957713|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720811|NCT02229825|142957713|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720812|NCT02229825|142957713|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720813|NCT02229825|142957715|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, Week 8 versus baseline.||||<0.0001
71720814|NCT02229825|142957715|OTHER|||||||0.001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.001
71720815|NCT02229825|142957715|OTHER||||||<|0.0001|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||<0.0001
71720816|NCT02229825|142957715|OTHER|||||||0.28|||||||Student statistic t-test|||Within-group comparison, week 8 versus baseline.||||0.28
71720817|NCT04343534|142957724|OTHER||Mean Difference (Final Values)|0.15||||0.092|TWO_SIDED|95.0|-0.02|0.33|||t-test, 2 sided|||"SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.~we conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions."||0.33|-0.02|0.092
71720818|NCT00803361|142957784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.006|TWO_SIDED|95.0|-2.76|-0.48||p-value is for Change from Baseline.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.48|-2.76|0.006
71720819|NCT00803361|142957785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.024|TWO_SIDED|95.0|-4.78|-0.34||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.34|-4.78|0.024
71720820|NCT00803361|142957786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15|||ANOVA|||||-0.15|-0.74|0.004
71720821|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.125|TWO_SIDED|95.0|-0.93|0.11||p-value is for Severity of Worst Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.93|0.125
71720822|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.014|TWO_SIDED|95.0|-0.75|-0.09||p-value is for Severity of Least Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.09|-0.75|0.014
71720823|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.012|TWO_SIDED|95.0|-0.93|-0.11||p-value is for Severity of Average Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.11|-0.93|0.012
71720824|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.002|TWO_SIDED|95.0|-1.14|-0.25||p-value is for Severity of Pain Right Now Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.25|-1.14|0.002
71720825|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.101|TWO_SIDED|95.0|-0.87|0.08||p-value is for Interference of Pain, General Activity, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-0.87|0.101
71720826|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.252|TWO_SIDED|95.0|-0.83|0.22||p-value is for Interference of Pain, Mood, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.22|-0.83|0.252
71720827|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.149|TWO_SIDED|95.0|-0.72|0.11||p-value is for Interference of Pain,Walking Ability, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.11|-0.72|0.149
71720828|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.367|TWO_SIDED|95.0|-0.71|0.26||p-value is for Interference of Pain, Normal Work, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.26|-0.71|0.367
71720829|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.395|TWO_SIDED|95.0|-0.59|0.24||p-value is for Interference of Pain, Relations with Others, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.24|-0.59|0.395
71720830|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.731|TWO_SIDED|95.0|-0.63|0.44||p-value is for Interference of Pain, Sleep, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.44|-0.63|0.731
71720831|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.186|TWO_SIDED|95.0|-0.85|0.17||p-value is for Interference of Pain, Enjoyment of Life, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-0.85|0.186
71720832|NCT00803361|142957787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.22|TWO_SIDED|95.0|-0.67|0.16||p-value is for Mean Interference Score, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.16|-0.67|0.220
71720833|NCT00803361|142957788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.076|TWO_SIDED|95.0|-1.29|0.06||p-value is for symptoms have disrupted your work/schoolwork - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.29|0.076
71720834|NCT00803361|142957788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.16|0.17||p-value is for symptoms disrupted social/leisure - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.17|-1.16|0.140
71720835|NCT00803361|142957788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.087|TWO_SIDED|95.0|-1.14|0.08||p-value is for symptoms disrupted family life - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.08|-1.14|0.087
71720836|NCT00803361|142957788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.083|TWO_SIDED|95.0|-3.46|0.21||p-value is for Global Functional Impairment Total Score - change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.21|-3.46|0.083
71720837|NCT00803361|142957789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32||||0.063|TWO_SIDED|95.0|-10.93|0.3||p-value is for Severity of Overall Pain, Past Week, Change|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||0.30|-10.93|0.063
71720838|NCT00803361|142957789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.66|TWO_SIDED|95.0|-6.64|4.22||p-value is for Severity of Headaches, Past Week, Change.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||4.22|-6.64|0.660
71720839|NCT00803361|142957789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.025|TWO_SIDED|95.0|-11.3|-0.76||p-value is for Severity of Back Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-0.76|-11.30|0.025
71720840|NCT00803361|142957789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93||||0.26|TWO_SIDED|95.0|-8.06|2.19||p-value is for Severity of Shoulder Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||2.19|-8.06|0.260
71720841|NCT00803361|142957789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.67||||0.145|TWO_SIDED|95.0|-8.61|1.28||p-value is for Pain Interference, Daily Activities, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||1.28|-8.61|0.145
71720842|NCT00803361|142957789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.15||||0.011|TWO_SIDED|95.0|-12.64|-1.66||p-value is for Pain During Waking Hours, Past Week, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||-1.66|-12.64|0.011
71720843|NCT00803361|142957790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.068|TWO_SIDED|95.0|-1.72|0.06||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline||||0.06|-1.72|0.068
71720844|NCT02674464|142957828|SUPERIORITY||Odds Ratio (OR)|0.9||||0.68|TWO_SIDED|95.0|0.62|1.3||The a priori threshold for statistical significance was \<0.05.|Generalized Estimating Equations (GEE)|Assuming an exchangeable correlation structure|CC/SC arm compared to the SCP arm.|||1.30|0.62|0.68
71720845|NCT02674464|142957829|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.6|TWO_SIDED|95.0|-1.32|2.3||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm was compared to the SCP arm.|||2.30|-1.32|0.60
71720846|NCT02674464|142957830|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.38|TWO_SIDED|95.0|-1.04|2.71||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression|||||2.71|-1.04|0.38
71720847|NCT02674464|142957831|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.05|TWO_SIDED|95.0|-2.43|0.01||The a priori threshold for statistical significance was \<0.05.|Mixed Effects Regression||CC/SC arm compared to SCP arm.|||0.01|-2.43|0.05
71720848|NCT01262638|142957864|SUPERIORITY||Difference in Least Squares Means|-15.7|||<|0.0001|TWO_SIDED|95.0|-21.8|-9.7|||ANCOVA|||||-9.7|-21.8|<0.0001
71720849|NCT01262638|142957864|SUPERIORITY||Difference in Least Squares Means|-22.9|||<|0.0001|TWO_SIDED|95.0|-28.9|-16.9|||ANCOVA|||||-16.9|-28.9|<0.0001
71720850|NCT01262638|142957864|SUPERIORITY||Difference in Least Squares Means|-24.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-18.4|||ANCOVA|||||-18.4|-30.5|<0.0001
71720851|NCT00894699|142957892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71829695|NCT03034915|143163487|OTHER||Odds Ratio (OR)|1.35||||0.003|TWO_SIDED|95.0|1.11|1.65|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.|||1.65|1.11|0.003
71720852|NCT00894699|142957892|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71720853|NCT02091362|142957929|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.11|3.4|||Mixed Models Analysis|||||3.40|1.11|<.001
71720854|NCT02091362|142957930|SUPERIORITY_OR_OTHER||LS Mean Difference|1.37|||<|0.01|TWO_SIDED|95.0|0.66|2.08|||Mixed Models Analysis|||||2.08|0.66|<0.01
71720855|NCT05319899|142957941|OTHER||Geometric Mean Ratio (%)|140.63|||||TWO_SIDED|90.0|118.94|166.26||||||Analysis was performed using analysis of variance (ANOVA).||166.26|118.94|
71720856|NCT05319899|142957941|OTHER||Geometric Mean Ratio (%)|77.65|||||TWO_SIDED|90.0|65.67|91.8||||||Analysis was performed using ANOVA.||91.80|65.67|
71720857|NCT05319899|142957942|OTHER||Geometric Mean Ratio (%)|128.23|||||TWO_SIDED|90.0|112.99|145.52||||||Analysis was performed using ANOVA.||145.52|112.99|
71720858|NCT05319899|142957942|OTHER||Geometric Mean Ratio (%)|95.94|||||TWO_SIDED|90.0|84.54|108.88||||||Analysis was performed using ANOVA.||108.88|84.54|
71720859|NCT00191945|142958044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-11.0|-4.8|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)|||-4.8|-11.0|<0.001
71720860|NCT00191945|142958045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.5|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.5|-3.6|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-3.6|-9.5|<0.001
71829696|NCT03034915|143163487|OTHER||Odds Ratio (OR)|1.23||||0.037|TWO_SIDED|95.0|1.01|1.5|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.|||1.50|1.01|0.037
71829697|NCT03034915|143163487|OTHER||Odds Ratio (OR)|0.91||||0.363|TWO_SIDED|95.0|0.75|1.11|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.|||1.11|0.75|0.363
71887492|NCT02167945|143295850|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.79||0.026|TWO_SIDED|95.0|-3.3|-0.21|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.21|-3.30|0.026
71720861|NCT00191945|142958046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2|STANDARD_ERROR_OF_MEAN|1.5||0.0009||95.0|-8.2|-2.2|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-2.2|-8.2|0.0009
71720862|NCT00191945|142958047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.3||0.0033||95.0|-6.4|-1.3|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-1.3|-6.4|0.0033
71720863|NCT00191945|142958048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.1||0.013||95.0|-4.9|-0.6||P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.|Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.||-0.6|-4.9|0.013
71829698|NCT02138006|143163489|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Log Rank|||||||0.30
71829699|NCT03861767|143163491|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.67|1.97||||||Low dose groups collapsed and compared to placebo||1.97|0.67|
71829700|NCT03861767|143163491|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.42|1.25||||||Intermediate dose groups were collapsed and compared to placebo||1.25|0.42|
71829701|NCT03861767|143163491|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.61|1.84||||||High dose groups were collapsed and compared to placebo||1.84|0.61|
71829702|NCT03861767|143163492|SUPERIORITY||Odds Ratio (OR)|1.03||||0.92|TWO_SIDED|95.0|0.52|2.03|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.03|0.52|0.92
71829703|NCT03861767|143163493|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8|TWO_SIDED|95.0|0.52|2.0|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.00|0.52|0.80
71829704|NCT03861767|143163494|SUPERIORITY||Odds Ratio (OR)|1.23||||0.65|TWO_SIDED|95.0|0.49|3.11|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.11|0.49|0.65
71720864|NCT00191945|142958051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.7|STANDARD_ERROR_OF_MEAN|2.3|<|0.001||95.0|-15.1|-6.2||P-value is for the difference between groups in the change from 12 weeks minus baseline.|Mixed Models Analysis|mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment\*visit interaction|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.|||-6.2|-15.1|<0.001
71720865|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.81||95.0|-3.39|4.33||P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.33|-3.39|0.810
71720866|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.96||||0.243||95.0|-1.35|5.29||P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.29|-1.35|0.243
71720867|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.56||||0.419||95.0|-2.26|5.39||P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||5.39|-2.26|0.419
71720868|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.41|||<|0.001||95.0|4.27|12.55||P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||12.55|4.27|<0.001
71720869|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.39||||0.042||95.0|0.13|6.65||P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.65|0.13|0.042
71720870|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.323||95.0|-4.06|1.35||P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||1.35|-4.06|0.323
71720871|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.452||95.0|-1.49|3.34||P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||3.34|-1.49|0.452
71720872|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.91||95.0|-2.59|2.9||P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||2.90|-2.59|0.910
71720873|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.006||95.0|1.04|6.08||P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||6.08|1.04|0.006
71720874|NCT00191945|142958052|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.541||95.0|-2.21|4.19||P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.||4.19|-2.21|0.541
71720875|NCT01576939|142958119|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.9906|TWO_SIDED|95.0|0.979|1.022|||Regression, Cox|This was a Cox proportional hazards model with dose as the single predictor.||||1.022|0.979|0.9906
71769130|NCT01551420|143038339|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|13.95||0.7363|TWO_SIDED|95.0|-5.01|3.67|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).||3.67|-5.01|0.7363
71887493|NCT02167945|143295850|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|95.0|-1.97|0.91|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.91|-1.97|0.472
71887494|NCT02167945|143295850|SUPERIORITY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.73||0.159|TWO_SIDED|95.0|-2.47|0.4|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.40|-2.47|0.159
71720876|NCT01576939|142958120|SUPERIORITY_OR_OTHER||Slope|0.2795||||0.1209|TWO_SIDED|95.0|-0.077|0.634|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||0.634|-0.077|0.1209
71720877|NCT01576939|142958121|SUPERIORITY_OR_OTHER||Slope|-0.285||||0.9832|TWO_SIDED|95.0|-27.28|26.71|||Regression, Linear|Linear regression model with dose as the single predictor in the model.||||26.71|-27.28|0.9832
71720878|NCT01576939|142958122|SUPERIORITY_OR_OTHER||Slope|0.03795||||0.0263|TWO_SIDED|95.0|0.00483|0.071|||Mixed Models Analysis|A repeated measures model with dose as the single predictor. QoL values were measured for each patient every week.||||0.071|0.00483|0.0263
71720879|NCT01576939|142958123|SUPERIORITY_OR_OTHER||Slope|0.0567||||0.0039|TWO_SIDED|95.0|0.0199|0.0935|||Mixed Models Analysis|A repeated measures model with dose as the single predictor and QoL values measured each week for each patient.||||0.0935|0.0199|0.0039
71720880|NCT02470585|142958150|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.277|0.683||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.683|0.277|<0.001
71720881|NCT02470585|142958151|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.572|||<|0.001|TWO_SIDED|95.0|0.433|0.756||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.756|0.433|<0.001
71887495|NCT02167945|143295850|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.84||0.125|TWO_SIDED|95.0|-2.95|0.36|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.36|-2.95|0.125
71720882|NCT02470585|142958152|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|0.683|||<|0.001|TWO_SIDED|95.0|0.562|0.831||A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.|Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Veliparib group (Arm 3) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||0.831|0.562|<0.001
71720883|NCT02470585|142958153|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.215||||0.335|TWO_SIDED|95.0|0.821|1.799|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.799|0.821|0.335
71720884|NCT02470585|142958154|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.1||||0.462|TWO_SIDED|95.0|0.855|1.414|||Log Rank|Stratified according to residual disease status and disease stage.|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.414|0.855|0.462
71769131|NCT01551420|143038339|SUPERIORITY||Mean Difference (Net)|-1.49|STANDARD_DEVIATION|8.12||0.2361|TWO_SIDED|95.0|-3.99|1.01|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).||1.01|-3.99|0.2361
71887496|NCT02167945|143295850|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.78||0.756|TWO_SIDED|95.0|-1.78|1.29|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.29|-1.78|0.756
71720885|NCT02470585|142958155|SUPERIORITY|Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.|Hazard Ratio (HR)|1.073||||0.45|TWO_SIDED|95.0|0.895|1.287|||Log Rank|Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status|Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|The secondary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -\> Placebo group (Arm 2) vs. the Placebo + Carboplatin + Paclitaxel -\> Placebo group (Arm 1).||1.287|0.895|0.450
71720886|NCT02470585|142958156|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.328|TWO_SIDED|95.0|0.567|1.429||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.429|0.567|0.328
71720887|NCT02470585|142958156|SUPERIORITY||Hazard Ratio (HR)|1.218||||0.808|TWO_SIDED|95.0|0.78|1.903||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.903|0.780|0.808
71720888|NCT02470585|142958157|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.116|TWO_SIDED|95.0|0.64|1.114||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.114|0.640|0.116
71720889|NCT02470585|142958157|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.352|TWO_SIDED|95.0|0.726|1.242||Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.242|0.726|0.352
71720890|NCT02470585|142958158|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.283|TWO_SIDED|95.0|0.782|1.144||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank|||Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.144|0.782|0.283
71720891|NCT02470585|142958158|SUPERIORITY||Hazard Ratio (HR)|1.034||||0.638|TWO_SIDED|95.0|0.859|1.244||Stratified by residual disease (none after primary surgery vs any residual disease after primary/interval surgery); disease stage (III vs IV); paclitaxel dosing (Q-weekly vs Q3-weekly); BRCA-Deficient status (Deficient vs wildtype or unknown/missing)|Log Rank||Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above|Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)||1.244|0.859|0.638
71720892|NCT00434993|142958166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.087|TWO_SIDED|95.0|-4.7|0.3||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.||0.3|-4.7|0.087
71720893|NCT00434993|142958167|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3||||0.302|TWO_SIDED|95.0|-4.0|14.7||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||14.7|-4.0|0.302
71720894|NCT00434993|142958168|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.9||||0.261|TWO_SIDED|95.0|-3.7|15.4||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.||||15.4|-3.7|0.261
71720895|NCT00434993|142958169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.023|TWO_SIDED|95.0|-4.9|-0.4||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||-0.4|-4.9|0.023
71720896|NCT00434993|142958170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.226|TWO_SIDED|95.0|-4.3|0.9||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||||0.9|-4.3|0.226
71720897|NCT00434993|142958171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.13|TWO_SIDED|95.0|-5.3|0.6|||ANCOVA|Adjusted for baseline shock.||||0.6|-5.3|0.130
71720898|NCT00434993|142958172|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.2||||0.176|TWO_SIDED|95.0|-3.1|19.6|||Regression, Logistic|Adjusted for baseline shock.||||19.6|-3.1|0.176
71720899|NCT00434993|142958173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.048|TWO_SIDED|95.0|-7.8|0.0|||ANCOVA|||||-0.0|-7.8|0.048
71720900|NCT00434993|142958174|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5||||0.265|TWO_SIDED|95.0|-6.9|25.9|||Regression, Logistic|||||25.9|-6.9|0.265
71720901|NCT02218697|142958195|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.13|||||TWO_SIDED|95.0|0.88|1.46|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.46|0.88|
71829705|NCT03861767|143163495|SUPERIORITY||Odds Ratio (OR)|1.62||||0.23|TWO_SIDED|95.0|0.73|3.62|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||3.62|0.73|0.23
71829706|NCT03861767|143163496|SUPERIORITY||Odds Ratio (OR)|1.42||||0.31|TWO_SIDED|95.0|0.71|2.86|||Regression, Logistic|||All intervention groups were grouped together and compared to placebo||2.86|0.71|0.31
71720902|NCT02218697|142958195|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.97|||||TWO_SIDED|95.0|0.78|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.21|0.78|
71720903|NCT02218697|142958195|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.98|1.4|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.40|0.98|
71720904|NCT02218697|142958195|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.84|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.||1.16|0.84|
71720905|NCT02218697|142958196|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.86|1.5|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.50|0.86|
71720906|NCT02218697|142958196|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.18|||||TWO_SIDED|95.0|0.96|1.45|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.45|0.96|
71720907|NCT02218697|142958196|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.26|||||TWO_SIDED|95.0|0.98|1.62|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.62|0.98|
71720908|NCT02218697|142958196|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|0.95|1.63|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.63|0.95|
71720909|NCT02218697|142958196|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|0.91|1.57|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.57|0.91|
71769132|NCT01551420|143038339|SUPERIORITY||Slope|-7.07|STANDARD_ERROR_OF_MEAN|4.02||0.0932|TWO_SIDED|95.0|-15.43|1.29|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.29|-15.43|0.0932
71887497|NCT02167945|143295850|SUPERIORITY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.78||0.315|TWO_SIDED|95.0|-2.32|0.75|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-2.32|0.315
71720910|NCT02218697|142958196|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.34|||||TWO_SIDED|95.0|1.05|1.7|||ANCOVA||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.||1.70|1.05|
71720911|NCT03306433|142958214|EQUIVALENCE|The null hypothesis is that there are no significant paired differences between the groups. The power calculation is based on the observed variation and number of participants|Paired difference t-test|-12.139|STANDARD_DEVIATION|7.101||0.0003|TWO_SIDED|||||Paired difference p value comparing UDMA-K18 vs Adhesive Control|Paired difference test, 2 sided||There are 12 participants (pairs) for this comparison|Paired difference test within each participant.||||0.0003
71720912|NCT03306433|142958214|EQUIVALENCE|Null hypothesis was that there were no differences between the groups|Paired difference t-test|-7.412|STANDARD_DEVIATION|6.049||0.0063|TWO_SIDED|||||Paired differrnce between UDMA-K18 and UDMA control|Paired difference test, 2 sided||There are 9 participant pairs for this comparison|Paired comparison||||0.0063
71720913|NCT03306433|142958215|EQUIVALENCE|The Null hypothesis was that there would be no differences between the groups|Chi Square on WSL Index frequency|15.77||||0.0033|TWO_SIDED||||||Chi-squared|||WSL Index is non-parametric||||0.0033
71720914|NCT03306433|142958215|EQUIVALENCE|The null hypothesis was that there would not be any differences between the groups|Chi Square on WSL Index frequency|6.8321||||0.145|TWO_SIDED||||||Chi-squared|||||||0.1450
71720915|NCT00294671|142958216|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 2 years.||||<0.001
71720916|NCT00294671|142958216|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 1years.||||0.02
71720917|NCT00294671|142958217|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 2 years.||||0.002
71720918|NCT00294671|142958217|SUPERIORITY_OR_OTHER|||||||0.1|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 1 year.||||0.10
71720919|NCT00294671|142958218|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 2 years.||||0.21
71769133|NCT01551420|143038339|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|6.0||0.0951|TWO_SIDED|95.0|-22.9|1.99|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||1.99|-22.9|0.0951
71769134|NCT01551420|143038339|SUPERIORITY||Slope|-4.91|STANDARD_ERROR_OF_MEAN|4.01||0.2346|TWO_SIDED|95.0|-13.3|3.43|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.||3.43|-13.3|0.2346
71769135|NCT02081248|143038378|SUPERIORITY|||||||0.37||||||Testing was performed at a significance level of 0.05|t-test, 2 sided|Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom||The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.37
71720920|NCT00294671|142958218|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 1 year.||||0.43
71720921|NCT00294671|142958219|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 2 years.||||0.001
71769136|NCT02081248|143038379|SUPERIORITY|||||||0.39||||||Testing performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.39
71829707|NCT03861767|143163497|SUPERIORITY||Beta-coefficient|0.0011|STANDARD_ERROR_OF_MEAN|0.042||0.97|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.97
71720922|NCT00294671|142958219|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 1 year.||||0.06
71720923|NCT00294671|142958220|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 2 years.||||0.06
71720924|NCT00294671|142958220|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 1 year.||||0.37
71829708|NCT03861767|143163498|SUPERIORITY||Beta-coefficient|-0.76|STANDARD_ERROR_OF_MEAN|0.74||0.3|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.30
71829709|NCT03861767|143163499|SUPERIORITY||Beta-coefficient|0.27|STANDARD_ERROR_OF_MEAN|0.59||0.65|TWO_SIDED||||||Regression, Linear|||All intervention groups were grouped together and compared to placebo||||0.65
71829710|NCT03861767|143163501|SUPERIORITY||Odds Ratio (OR)|1.45||||0.27|TWO_SIDED|95.0|0.74|2.86|||Regression, Logistic|||||2.86|0.74|0.27
71720925|NCT01893411|142958227|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean difference|-0.04|||=|0.65|TWO_SIDED|95.0|-0.23|0.14|||Mixed Model Repeated Measure|||||0.14|-0.23|= 0.65
71720926|NCT01893411|142958227|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|-0.04|||=|0.741|TWO_SIDED|95.0|-0.26|0.18|||Mixed Model Repeated Measure|||||0.18|-0.26|= 0.741
71720927|NCT01893411|142958228|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.16|||=|0.075|TWO_SIDED|95.0|-0.02|0.34|||Mixed Model Repeated Measure|||||0.34|-0.02|= 0.075
71720928|NCT01893411|142958228|SUPERIORITY_OR_OTHER_LEGACY||LS-Mean difference|0.06|||=|0.603|TWO_SIDED|95.0|-0.16|0.27|||Mixed Model Repeated Measure|||||0.27|-0.16|= 0.603
71720929|NCT02403817|142958252|OTHER|This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).||||||5e-05|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.00005
71720930|NCT02403817|142958253|OTHER|||||||0.018|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).||||0.018
71720931|NCT03053440|142958254|SUPERIORITY||Risk Difference (RD)|10.2||||0.0921|TWO_SIDED|95.0|-1.5|22.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by the stratification factors per interactive response technology (IRT). p value is 2-sided||||22.0|-1.5|0.0921
71720932|NCT01701362|142958276|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1823||95.0|-0.54|0.1|||Mixed Model Repeated Measures Analysis|Mixed Model Repeated Measures = MMRM|MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method|||0.10|-0.54|0.1823
71720933|NCT01701362|142958277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||||||The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.|Cochran-Mantel-Haenszel|||||||0.0012
71720934|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.14||0.0119||95.0|-0.62|-0.08|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 1||-0.08|-0.62|0.0119
71720935|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.14||0.0135||95.0|-0.62|-0.07|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 2||-0.07|-0.62|0.0135
71720936|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.14||0.0028||95.0|-0.69|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 3||-0.14|-0.69|0.0028
71720937|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0016||95.0|-0.72|-0.17|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 4||-0.17|-0.72|0.0016
71720938|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 5||-0.20|-0.75|0.0007
71720939|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0006||95.0|-0.76|-0.21|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 6||-0.21|-0.76|0.0006
71720940|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 7||-0.20|-0.75|0.0008
71829711|NCT03861767|143163502|SUPERIORITY||Odds Ratio (OR)|2.98||||0.01|TWO_SIDED|95.0|1.19|7.44|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||7.44|1.19|0.01
71887498|NCT02167945|143295851|SUPERIORITY||LS Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.03||0.216|TWO_SIDED|95.0|-3.3|0.75|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.75|-3.30|0.216
71720941|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.14||0.0003||95.0|-0.79|-0.24|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 8||-0.24|-0.79|0.0003
71720942|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.26|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 9||-0.26|-0.82|0.0001
71829712|NCT03861767|143163503|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.01|TWO_SIDED|95.0|1.34|5.3|||Regression, Logistic|||All intervention groups were collapsed and compared to placebo||5.30|1.34|<0.01
71829713|NCT03861767|143163504|SUPERIORITY||Odds Ratio (OR)|0.9||||0.72|TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||All intervention groups were collapsed into one group and compared with placebo. Patients were compared whether they were discharged home or other.||1.56|0.52|0.72
71720943|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.77|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 10||-0.22|-0.77|0.0005
71720944|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0007||95.0|-0.76|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 11||-0.20|-0.76|0.0007
71720945|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001||95.0|-0.82|-0.27|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 12||-0.27|-0.82|0.0001
71720946|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.84|-0.28|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 13||-0.28|-0.84|<0.0001
71720947|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0005||95.0|-0.78|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 14||-0.22|-0.78|0.0005
71720948|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.15||0.0031||95.0|-0.71|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 15||-0.14|-0.71|0.0031
71720949|NCT01701362|142958278|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12||0.0001||95.0|-0.71|-0.23|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week \& treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Overall||-0.23|-0.71|0.0001
71720950|NCT01701362|142958279|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.005||95.0|-0.77|-0.14|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.14|-0.77|0.0050
71720951|NCT01701362|142958280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0168||95.0|-0.7|-0.07|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||||-0.07|-0.70|0.0168
71720952|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.6841||95.0|-0.09|0.06|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for mobility||0.06|-0.09|0.6841
71720953|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6564||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for self-care||0.04|-0.07|0.6564
71720954|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.043||0.859||95.0|-0.08|0.09|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for usual activities||0.09|-0.08|0.8590
71720955|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.1628||95.0|-0.14|0.02|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for pain/discomfort||0.02|-0.14|0.1628
71720956|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.4654||95.0|-0.05|0.1|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for anxiety/depression||0.10|-0.05|0.4654
71720957|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.017||0.5||95.0|-0.02|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 1997 Index score||0.04|-0.02|0.5000
71720958|NCT01701362|142958281|SUPERIORITY_OR_OTHER_LEGACY||leaset squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.026||0.5493||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 2001 Index Score||0.04|-0.07|0.5493
71720959|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.8||0.0545||95.0|-0.07|7.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Disturbance Score||7.00|-0.07|0.0545
71720960|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3913||95.0|-6.47|2.54|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Adequancy Score||2.54|-6.47|0.3913
71720961|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|2.04||0.6059||95.0|-5.06|2.96|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Snoring Score||2.96|-5.06|0.6059
71720962|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.7317||95.0|-2.76|3.93|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Awaken Short of Breath Score||3.93|-2.76|0.7317
71720963|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2663||95.0|-0.45|0.12|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Quantity of Sleep Score (hours)||0.12|-0.45|0.2663
71720964|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1562||95.0|-5.08|0.82|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Somnolence Score||0.82|-5.08|0.1562
71720965|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||least square mean difference|1.7|STANDARD_ERROR_OF_MEAN|1.45||0.249||95.0|-1.18|4.53|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Problem Index (9) Score||4.53|-1.18|0.2490
71720966|NCT01701362|142958283|SUPERIORITY_OR_OTHER_LEGACY||leaet squares mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0609||95.0|-0.15|0.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Optimal Sleep Score||0.00|-0.15|0.0609
71720967|NCT01701362|142958284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7165||||||p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.|Cochran-Mantel-Haenszel|||||||0.7165
71720968|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2||||0.0028||95.0|1.5|6.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.86|1.50|0.0028
71720969|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.036||95.0|1.03|2.68|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||2.68|1.03|0.0360
71720970|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0235||95.0|1.07|2.45|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||2.45|1.07|0.0235
71829714|NCT01087762|143163506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3|||=|0.004|TWO_SIDED|95.0|6.3|32.4||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||32.4|6.3|=0.004
71887499|NCT02167945|143295851|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.95||0.074|TWO_SIDED|95.0|-3.58|0.17|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.17|-3.58|0.074
71887500|NCT02167945|143295851|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.056|TWO_SIDED|95.0|-3.67|0.05|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.05|-3.67|0.056
71720971|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.0619||95.0|0.98|2.24|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.24|0.98|0.0619
71720972|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.0677||95.0|0.97|2.2|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||2.20|0.97|0.0677
71720973|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.0707||95.0|0.97|2.16|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.16|0.97|0.0707
71720974|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.1313||95.0|0.91|2.06|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.06|0.91|0.1313
71720975|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.3072||95.0|0.82|1.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||1.86|0.82|0.3072
71720976|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.3947||95.0|0.79|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||1.80|0.79|0.3947
71720977|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.1462||95.0|0.9|2.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.05|0.90|0.1462
71720978|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6854||95.0|0.72|1.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||1.64|0.72|0.6854
71720979|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.5025||95.0|0.76|1.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||1.74|0.76|0.5025
71887501|NCT02167945|143295851|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|1.02||0.411|TWO_SIDED|95.0|-2.84|1.16|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.16|-2.84|0.411
71720980|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.4908||95.0|0.76|1.76|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||1.76|0.76|0.4908
71720981|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.4245||95.0|0.78|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||1.80|0.78|0.4245
71720982|NCT01701362|142958285|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8464||95.0|0.61|1.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||1.49|0.61|0.8464
71720983|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.1633||95.0|0.74|6.0|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1||6.00|0.74|0.1633
71720984|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0652||95.0|0.96|3.85|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2||3.85|0.96|0.0652
71720985|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.0039||95.0|1.29|3.77|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3||3.77|1.29|0.0039
71887502|NCT02167945|143295851|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.93||0.065|TWO_SIDED|95.0|-3.55|0.11|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||0.11|-3.55|0.065
71720986|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0382||95.0|1.03|2.83|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4||2.83|1.03|0.0382
71720987|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||0.0137||95.0|1.14|3.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5||3.05|1.14|0.0137
71720988|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0693||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6||2.49|0.97|0.0693
71769137|NCT02081248|143038380|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.||||0.17
71769138|NCT02081248|143038383|SUPERIORITY|||||||0.21||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.21
71720989|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.0349||95.0|1.04|2.73|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7||2.73|1.04|0.0349
71720990|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1227||95.0|0.91|2.29|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8||2.29|0.91|0.1227
71720991|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.65||||0.0364||95.0|1.03|2.63|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9||2.63|1.03|0.0364
71720992|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0667||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10||2.49|0.97|0.0667
71720993|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.0176||95.0|1.1|2.84|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11||2.84|1.10|0.0176
71720994|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.03||||0.003||95.0|1.27|3.23|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12||3.23|1.27|0.0030
71887503|NCT02167945|143295851|SUPERIORITY||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.93||0.026|TWO_SIDED|95.0|-3.91|-0.25|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 24||-0.25|-3.91|0.026
71887504|NCT02167945|143295852|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.95||0.035|TWO_SIDED|95.0|-3.86|-0.14|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes (PRO) score and SVR12 status as covariates."||-0.14|-3.86|0.035
71720995|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.0256||95.0|1.07|2.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13||2.74|1.07|0.0256
71720996|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.0314||95.0|1.05|2.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14||2.64|1.05|0.0314
71720997|NCT01701362|142958286|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.1889||95.0|0.85|2.21|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15||2.21|0.85|0.1889
71720998|NCT02978157|142958292|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71720999|NCT00066222|142958386|OTHER|||||||||||||||||This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.|If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.|||
71721000|NCT00066222|142958389|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.|||
71721001|NCT00066222|142958390|OTHER||||||||||||||||||The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.|||
71721002|NCT02767869|142958400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71721003|NCT02767869|142958401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.530
71721004|NCT02767869|142958402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
71721005|NCT02767869|142958403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
71721006|NCT02767869|142958404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
71769139|NCT02081248|143038383|SUPERIORITY|||||||0.25||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.||||0.25
71769140|NCT02081248|143038384|SUPERIORITY|||||||0.8||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.||||0.80
71769141|NCT02081248|143038385|SUPERIORITY|||||||0.73||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.||||0.73
71769142|NCT02081248|143038385|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.||||0.26
71721007|NCT02767869|142958405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
71721008|NCT02767869|142958406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
71721009|NCT02767869|142958407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.919|||||||Wilcoxon (Mann-Whitney)|||||||0.919
71721010|NCT02767869|142958408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
71721011|NCT02767869|142958409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.347|||||||Wilcoxon (Mann-Whitney)|||||||0.347
71721012|NCT02767869|142958410|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71721013|NCT02767869|142958411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.410
71721014|NCT02767869|142958412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71721015|NCT04301934|142958414|NON_INFERIORITY|The prevalence of UTI for the LASER group and vaginal estrogen group was calculated. Non-inferiority test using Farrington-Manning method was applied to test the risk difference against the pre-specified non-inferiority margin (20%).||||||0.034|||||||Farrington-Manning|||||||0.034
71721016|NCT00394329|142958416|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.56|STANDARD_ERROR_OF_MEAN|0.28||0.066|TWO_SIDED|95.0|0.32|0.96||Hochberg adjustment was applied to the p-value to account for each of three active group comparisons to the placebo group. The unadjusted p-value is 0.033.|Regression, Cox|||||0.96|0.32|0.066
71721017|NCT03629223|142958445|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%. In the below, LS-means = least squares mean.|Percentage of Ratio of Geometric LS-Mean|115.35|||||TWO_SIDED|90.0|108.55|122.58||||||||122.58|108.55|
71721018|NCT03629223|142958445|OTHER||Percentage of ratio of Geometric LS-Mean|186.37|||||TWO_SIDED|90.0|163.61|212.28||||||||212.28|163.61|
71721019|NCT03629223|142958445|OTHER||Percentage of ratio of Geometric LS-Mean|163.15|||||TWO_SIDED|90.0|146.17|182.1||||||||182.10|146.17|
71829715|NCT01087762|143163506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|||<|0.001|TWO_SIDED|95.0|12.3|38.2||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||38.2|12.3|<0.001
71887505|NCT02167945|143295852|SUPERIORITY||LS Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.88||0.015|TWO_SIDED|95.0|-3.88|-0.42|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 12~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.42|-3.88|0.015
71721020|NCT03629223|142958446|EQUIVALENCE|Analysis was performed with Equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|115.34|||||TWO_SIDED|90.0|108.51|122.6||||||||122.60|108.51|
71721021|NCT03629223|142958446|OTHER||Percentage of ratio of Geometric LS-Mean|186.67|||||TWO_SIDED|90.0|163.78|212.77||||||||212.77|163.78|
71769143|NCT02081248|143038385|SUPERIORITY|||||||0.74||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.||||0.74
71769144|NCT02081248|143038385|SUPERIORITY|||||||0.56||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.||||0.56
71769145|NCT02081248|143038385|SUPERIORITY|||||||0.79||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.||||0.79
71769146|NCT02081248|143038386|SUPERIORITY|||||||1||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.||||1.00
71887506|NCT02167945|143295852|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.88||0.048|TWO_SIDED|95.0|-3.46|-0.01|||ANCOVA||F4 - F0-F1|F0-F1 vs F4 at Post-treatment Week 12||-0.01|-3.46|0.048
71769147|NCT02081248|143038386|SUPERIORITY|||||||0.77||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.77
71769148|NCT02081248|143038386|SUPERIORITY|||||||0.69||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.69
71769149|NCT02081248|143038386|SUPERIORITY|||||||0.26||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.||||0.26
71721022|NCT03629223|142958446|OTHER||Percentage of ratio of Geometric LS-Mean|163.26|||||TWO_SIDED|90.0|146.09|182.46||||||||182.46|146.09|
71721023|NCT03629223|142958447|EQUIVALENCE|Analysis was performed with equivalence acceptance range for 90% confidence interval (CI) as 80.00% - 125.00%.|Percentage of ratio of Geometric LS-Mean|113.57|||||TWO_SIDED|90.0|107.62|119.85||||||||119.85|107.62|
71721024|NCT03629223|142958447|OTHER||Percentage of ratio of Geometric LS-Mean|236.51|||||TWO_SIDED|90.0|215.69|259.34||||||||259.34|215.69|
71721025|NCT03629223|142958447|OTHER||Percentage of ratio of Geometric LS-Mean|199.61|||||TWO_SIDED|90.0|176.44|225.82||||||||225.82|176.44|
71721026|NCT04660552|142958467|EQUIVALENCE|The post treatment cars scores of active and sham group will be statistically different as measured by independent sample t-test with p\<.05|Mean Difference (Net)|7.23|STANDARD_DEVIATION|4.2||0.01|TWO_SIDED|95.0|2.357|12.107|||t-test, 2 sided|||||12.107|2.357|0.01
71721027|NCT00617097|142958478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.94|TWO_SIDED|95.0|-13.7|12.6|||Regression, Linear|||expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||12.6|-13.7|0.94
71721028|NCT00617097|142958478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.9|TWO_SIDED|95.0|-15.1|13.2|||Regression, Linear|||after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||13.2|-15.1|0.9
71721029|NCT00617097|142958478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.49|TWO_SIDED|95.0|-18.6|9.0|||Regression, Linear|||during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||9|-18.6|0.49
71721030|NCT00617097|142958478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0||||0.03|TWO_SIDED|95.0|-28.3|-1.7|||Regression, Linear|||after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||-1.7|-28.3|0.03
71721031|NCT00617097|142958478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7|TWO_SIDED|95.0|-12.2|18.0|||Regression, Linear|||immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||18|-12.2|0.7
71721032|NCT00617097|142958478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.52|TWO_SIDED|95.0|-17.0|8.8|||Regression, Linear|||30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)||8.8|-17|.52
71721033|NCT00617097|142958479|SUPERIORITY_OR_OTHER|||||||0.93|||||||Regression, Linear|||greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)||||0.93
71721034|NCT00617097|142958480|SUPERIORITY_OR_OTHER|||||||0.07|||||||Chi-squared|||greater number is worse (i.e., more symptoms)||||0.07
71829716|NCT01087762|143163507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.7|||<|0.001|TWO_SIDED|95.0|25.4|50.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||50.0|25.4|<0.001
71887507|NCT02167945|143295852|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.99||0.466|TWO_SIDED|95.0|-2.67|1.22|||ANCOVA||F2 - F0-F1|"F0-F1 vs F2 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||1.22|-2.67|0.466
71721035|NCT00617097|142958481|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||minor complications greater number is worse (i.e., more complications)||||1
71721036|NCT00617097|142958481|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||serious complications||||0.15
71721037|NCT00349349|142958616|SUPERIORITY_OR_OTHER||percentage of responders|0.49|||<|0.0001|TWO_SIDED|95.3|0.39|0.6||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.60|0.39|<0.0001
71721038|NCT00349349|142958616|SUPERIORITY_OR_OTHER||percentage of responders|0.43|||<|0.0001|TWO_SIDED|95.3|0.33|0.53||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.53|0.33|<0.0001
71721039|NCT00349349|142958616|SUPERIORITY_OR_OTHER||percentage of responders|0.63|||<|0.001|TWO_SIDED|95.3|0.35|0.85||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.|||0.85|0.35|<0.001
71721040|NCT04776720|142958681|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
71721041|NCT04776720|142958682|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
71721042|NCT04776720|142958683|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with variance co-variance matrix||||5.84|-3.87|0.689
71721043|NCT04776720|142958684|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
71721044|NCT04776720|142958685|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
71721045|NCT04776720|142958686|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
71721046|NCT04776720|142958687|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
71721047|NCT04776720|142958688|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|Adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
71721048|NCT04776720|142958689|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
71721049|NCT04776720|142958690|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
71721050|NCT00803595|142958717|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|-0.6||||0.748|TWO_SIDED|95.0|-9.9|6.9||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||6.9|-9.9|0.748
71721051|NCT00803595|142958717|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.8||||0.038|TWO_SIDED|95.0|-18.2|-0.4||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||Null hypothesis was that there was no difference in the time to illness alleviation||-0.4|-18.2|0.038
71721052|NCT00803595|142958717|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|12.2||||0.104|TWO_SIDED|95.0|-1.5|17.2|||Generalized Wilcoxon test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not \>18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.||17.2|-1.5|0.104
71721053|NCT00803595|142958718|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.3||||0.318|TWO_SIDED|95.0|-2.8|9.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||9.1|-2.8|0.318
71721054|NCT00803595|142958718|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.981|TWO_SIDED|95.0|-5.8|5.7||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||5.7|-5.8|0.981
71721055|NCT00803595|142958718|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.7||||0.344|TWO_SIDED|95.0|-9.1|3.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.||3.1|-9.1|0.344
71721056|NCT00851890|142958719|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.012
71721057|NCT00851890|142958719|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.071
71721058|NCT00851890|142958719|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.140
71721059|NCT00851890|142958720|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.008
71721060|NCT00851890|142958720|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.003
71721061|NCT00851890|142958720|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided \>95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.||||0.009
71721062|NCT00851890|142958727|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.018
71721063|NCT00851890|142958727|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.020
71769150|NCT04268823|143038463|SUPERIORITY||Least Squares mean|-0.203|STANDARD_ERROR_OF_MEAN|0.1938||0.298|TWO_SIDED|80.0|-0.524|0.119|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.119|-0.524|0.298
71829717|NCT01087762|143163507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|28.9|53.3||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||53.3|28.9|<0.001
71721064|NCT00851890|142958727|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.||||0.054
71721065|NCT00851890|142958727|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.010
71721066|NCT00851890|142958727|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.005
71721067|NCT00851890|142958727|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.||||0.014
71721068|NCT00851890|142958728|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
71721069|NCT00851890|142958728|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.026
71721070|NCT00851890|142958728|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.138
71721071|NCT00851890|142958729|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
71721072|NCT00851890|142958729|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.473
71721073|NCT00851890|142958729|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.031
71721074|NCT00851890|142958730|SUPERIORITY_OR_OTHER|||||||0.209|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||0.209
71721075|NCT00851890|142958730|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact|||||||1.000
71721076|NCT03135431|142958733|NON_INFERIORITY|\<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.|Mean Difference (Final Values)|-0.04121||||0.08|ONE_SIDED|95.0||0.0712|||t-test, 1 sided|||Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).|Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.|.0712||0.08
71721077|NCT03135431|142958734|SUPERIORITY||Mean Difference (Final Values)|-11.21|||||TWO_SIDED|95.0|-14.1|-8.3|||||Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.|||-8.3|-14.1|
71721078|NCT03135431|142958735|SUPERIORITY||Mean Difference (Net)|-9.17||||0.77|TWO_SIDED|95.0|-72.5|54.17|||t-test, 2 sided|||Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.||54.17|-72.5|0.77
71721079|NCT00375674|142958738|SUPERIORITY||Cox Proportional Hazard|0.761||||0.03|TWO_SIDED|95.0|0.594|0.975|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||Superiority analysis||0.975|0.594|0.030
71721080|NCT00375674|142958739|SUPERIORITY||Cox Proportional Hazard|0.811||||0.077|TWO_SIDED|95.0|0.643|1.023|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group||Superiority analysis||1.023|0.643|0.077
71721081|NCT00375674|142958740|SUPERIORITY||Hazard Ratio (HR)|0.929||||0.661|TWO_SIDED|95.0|0.67|1.289|||Log-rank test|||Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||1.289|0.670|0.661
71721082|NCT03744910|142958749|OTHER||Treatment difference|-2.75|STANDARD_ERROR_OF_MEAN|1.563|||TWO_SIDED|95.0|-5.84|0.35||||||||0.35|-5.84|
71721083|NCT03430843|142958788|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.57|0.85|||1-sided, Log Rank Test|||||0.85|0.57|0.0001
71721084|NCT03037476|142958811|OTHER|General Linear Model|Slope|-0.235||||0.03|TWO_SIDED|95.0|-0.446|-0.023|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 6 Month Follow-up Outcomes reported in this section.||-.023|-.446|0.03
71721085|NCT03037476|142958811|OTHER|General Linear Model|Slope|-0.149||||0.164|TWO_SIDED|95.0|-0.36|0.061|||Mixed Models Analysis|Negative Binomial Regression||Changes from Baseline to 12 Month Follow-up reported in this section.||.061|-.360|0.164
71721086|NCT03037476|142958812|OTHER|General Linear Model|Slope|-0.24||||0.603|TWO_SIDED|95.0|-1.12|0.65|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 6 Month Followup||.650|-1.120|.603
71721087|NCT03037476|142958812|OTHER|General Linear Model|Slope|-0.336||||0.465|TWO_SIDED|95.0|-1.238|0.566|||Mixed Models Analysis|Poisson Regression||Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followup||.566|-1.238|.465
71721088|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.059||||0.486|TWO_SIDED|95.0|-0.227|0.108|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 6 Month Followup||.108|-.227|.486
71721089|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.006||||0.942|TWO_SIDED|95.0|-0.16|0.172|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followup||.172|-.160|.942
71721090|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.042||||0.552|TWO_SIDED|95.0|-0.18|0.097|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followup||.097|-.180|.552
71721091|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.037||||0.608|TWO_SIDED|95.0|-0.104|0.177|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followup||.177|-.104|.608
71721092|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.015||||0.84|TWO_SIDED|95.0|-0.13|0.16|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followup||.160|-.130|.840
71721093|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.007||||0.927|TWO_SIDED|95.0|-0.142|0.155|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followup||.155|-.142|.927
71721094|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.01||||0.932|TWO_SIDED|95.0|-0.244|0.223|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||.223|-.244|.932
71721095|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.057||||0.648|TWO_SIDED|95.0|-0.3|0.187|||Mixed Models Analysis|Poisson Regression||Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||0.187|-.300|.648
71721096|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.059||||0.702|TWO_SIDED|95.0|-0.363|0.245|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followup||.245|-.363|.702
71721097|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.1||||0.524|TWO_SIDED|95.0|-0.408|0.208|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followup||.208|-.408|.524
71721098|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.008||||0.913|TWO_SIDED|95.0|-0.137|0.153|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followup||.153|-.137|.913
71721099|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.032||||0.676|TWO_SIDED|95.0|-0.117|0.181|||Mixed Models Analysis|Poisson Regresision||Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followup||.181|-.117|.676
71721100|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.035||||0.712|TWO_SIDED|95.0|-0.223|0.152|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followup||.152|-.223|.712
71721101|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.005||||0.956|TWO_SIDED|95.0|-0.186|0.197|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followup||0.197|-.186|.956
71721102|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.149||||0.446|TWO_SIDED|95.0|-0.234|0.531|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followup||.531|-.234|.446
71721103|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.055||||0.793|TWO_SIDED|95.0|-0.353|0.462|||Mixed Models Analysis|Poisson Regression||Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followup||.462|-.353|.793
71721104|NCT03037476|142958813|OTHER|General Linear Model|Slope|-0.001||||0.999|TWO_SIDED|95.0|-2.005|2.003|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 6 Month Followup||2.003|-2.005|.999
71721105|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.999||||0.397|TWO_SIDED|95.0|-1.312|3.31|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Heroin Use from Baseline to 12 Month Followup||3.310|-1.312|.397
71721106|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.465||||0.303|TWO_SIDED|95.0|-0.419|1.349|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup||1.349|-.419|.303
71721107|NCT03037476|142958813|OTHER|General Linear Model|Slope|0.939|||<|0.05|TWO_SIDED|95.0|0.128|1.751|||Mixed Models Analysis|Negative Binomial Regression||Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup||1.751|.128|<.05
71721108|NCT03037476|142958814|OTHER|General Linear Model|Slope|-0.1816||||0.151|TWO_SIDED|95.0|-0.4295|0.0663|||Mixed Models Analysis|Negative binomial regression||Change in ASSIST Score over time: 6 month follow up||0.0663|-0.4295|0.151
71721109|NCT03037476|142958814|OTHER|General Linear Model|Slope|-0.0601||||0.642|TWO_SIDED|95.0|-0.3133|0.1931|||Mixed Models Analysis|Negative Binomial Regression||Changes in ASSIST scores at 12 month follow up||0.1931|-0.3133|0.642
71721110|NCT03037476|142958815|OTHER|General Linear Model|Slope|-0.2177||||0.074|TWO_SIDED|95.0|-0.4566|0.0213|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 6 month follow up||0.0213|-0.4566|0.074
71721111|NCT03037476|142958815|OTHER|General Linear Model|Slope|-0.1165||||0.351|TWO_SIDED|95.0|-0.3612|0.1282|||Mixed Models Analysis|Negative Binomial Regression||Change in consequence score at 12 month follow up||0.1282|-0.3612|0.351
71721112|NCT03037476|142958816|OTHER|General Linear Model|Slope|0.044||||0.255|TWO_SIDED|95.0|-0.032|0.1197|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity at 6 months (reported by number of standard drinks)||0.1197|-0.032|0.255
71721113|NCT03037476|142958816|OTHER|General Linear Model|Slope|0.0315||||0.428|TWO_SIDED|95.0|-0.0463|0.1092|||Mixed Models Analysis|Negative Binomial Regression||Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-up||0.1092|-0.0463|0.428
71721114|NCT03037476|142958817|OTHER|General Linear Model|Slope|0.0021||||0.966|TWO_SIDED|95.0|-0.0936|0.0978|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 6 months||0.0978|-0.0936|0.966
71721115|NCT03037476|142958817|OTHER|General Linear Model|Slope|-0.0559||||0.265|TWO_SIDED|95.0|-0.1542|0.0424|||Mixed Models Analysis|Negative Binomial Regression||Change in DDQ score at 12 month follow-up||0.0424|-0.1542|0.265
71721116|NCT03037476|142958818|OTHER|General Linear Model|Slope|-0.0128||||0.868|TWO_SIDED|95.0|-0.1633|0.1378|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 6 month follow-up||0.1378|-0.1633|0.868
71721117|NCT03037476|142958818|OTHER|General Linear Model|Slope|-0.0445||||0.573|TWO_SIDED|95.0|-0.1993|0.1102|||Mixed Models Analysis|Negative Binomial Regression||Change in RAPI count at 12 month follow-up||0.1102|-0.1993|0.573
71721118|NCT03037476|142958819|OTHER|General Linear Model|Slope|-0.0899||||0.266|TWO_SIDED|95.0|-0.2484|0.0685|||Mixed Models Analysis|Negative Binomial Regression||Change in past 12 month marijuana use at 6 month follow-up||0.0685|-0.2484|0.266
71721119|NCT03037476|142958819|OTHER|General Linear Model|Slope|-0.0197||||0.816|TWO_SIDED|95.0|-0.1859|0.1465|||Mixed Models Analysis|Negative Binomial Regression||Past 12 month marijuana use at 12 month follow-up||0.1465|-0.1859|0.816
71721120|NCT03037476|142958819|OTHER|General Linear Model|Slope|-0.1031||||0.209|TWO_SIDED|95.0|-0.2639|0.0577|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 6 month follow-up||0.0577|-0.2639|0.209
71721121|NCT03037476|142958819|OTHER|General Linear Model|Slope|-0.006||||0.944|TWO_SIDED|95.0|-0.1729|0.1608|||Mixed Models Analysis|Negative Binomial Regression||Change in past 6 month marijuana use at 12 month follow-up||0.1608|-0.1729|0.944
71721122|NCT03037476|142958819|OTHER|General Linear Model|Slope|-0.0391||||0.654|TWO_SIDED|95.0|-0.2102|0.132|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 6 month follow-up||0.1320|-0.2102|0.654
71721123|NCT03037476|142958819|OTHER|General Linear Model|Slope|-0.0646||||0.481|TWO_SIDED|95.0|-0.2444|0.1152|||Mixed Models Analysis|Negative Binomial Regression||Change in past month marijuana use at 12 month follow-up||0.1152|-0.2444|0.481
71721124|NCT03037476|142958820|OTHER|General Linear Model|Slope|-0.0411||||0.487|TWO_SIDED|95.0|-0.1569|0.0747|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 6 month follow-up||0.0747|-0.1569|0.487
71721125|NCT03037476|142958820|OTHER|General Linear Model|Slope|0.0177||||0.772|TWO_SIDED|95.0|-0.1021|0.1375|||Mixed Models Analysis|Negative Binomial Regression||Change in RMPI count at 12 month follow-up||0.1375|-0.1021|0.772
71721126|NCT03037476|142958821|OTHER|General Linear Model|Slope|0.1285||||0.075|TWO_SIDED|95.0|-0.0131|0.2702|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 6 month follow up||0.2702|-0.0131|0.075
71721127|NCT03037476|142958821|OTHER|General Linear Model|Slope|0.0936||||0.207|TWO_SIDED|95.0|-0.0517|0.2388|||Mixed Models Analysis|Negative Binomial Regression||Change in PBS count at 12 month follow up||0.2388|-0.0517|0.207
71721128|NCT03037476|142958822|OTHER|General Linear Model|Slope|-0.1604|||<|0.001|TWO_SIDED|95.0|-0.2525|-0.0683|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (in perceived days of use in past year) at 6 month follow up||-0.0683|-0.2525|<0.001
71721129|NCT03037476|142958822|OTHER|General Linear Model|Slope|-0.1441|||<|0.003|TWO_SIDED|95.0|-0.2404|-0.0478|||Mixed Models Analysis|Negative Binomial Regression||Change in perceived norm (perceived number of days of use in past year) at 12 month follow up||-0.0478|-0.2404|<.003
71721130|NCT03037476|142958823|OTHER|General Linear Model|Slope|-0.0157||||0.743|TWO_SIDED|95.0|-0.1096|0.0782|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 6 month follow-up||0.0782|-0.1096|0.743
71721131|NCT03037476|142958823|OTHER|General Linear Model|Slope|0.0133||||0.784|TWO_SIDED|95.0|-0.0816|0.1081|||Mixed Models Analysis|Poisson regression||Change in MSLQ score at 12 month follow up||0.1081|-0.0816|0.784
71721132|NCT03037476|142958824|OTHER|General Linear Model|Slope|-0.0061||||0.914|TWO_SIDED|95.0|-0.1161|0.104|||Mixed Models Analysis|Poisson regression||Change in cumulative grade point average at 6 month follow up||0.104|-0.1161|0.914
71721133|NCT03037476|142958824|OTHER|General Linear Model|Slope|-0.0092||||0.871|TWO_SIDED|95.0|-0.1202|0.1018|||Mixed Models Analysis|General Linear Model||Change in cumulative grade point average at 12 month follow up||0.1018|-0.1202|0.871
71721134|NCT03037476|142958824|OTHER|General Linear Model|Slope|0.003||||0.957|TWO_SIDED|95.0|-0.1063|0.1124|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 6 month follow-up||0.1124|-0.1063|0.957
71721135|NCT03037476|142958824|OTHER|General Linear Model|Slope|0.0006||||0.992|TWO_SIDED|95.0|-0.1098|0.1109|||Mixed Models Analysis|Poisson regression||Change in last term GPA at 12 month follow-up||0.1109|-0.1098|0.992
71721136|NCT03037476|142958825|OTHER|General Linear Model|Slope|0.039||||0.447|TWO_SIDED|95.0|-0.0615|0.1395|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 6 month follow-up||0.1395|-.0615|0.447
71721137|NCT03037476|142958825|OTHER|General Linear Model|Slope|0.0398||||0.443|TWO_SIDED|95.0|-0.0619|0.1414|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol frequency at 12 month follow-up||0.1414|-0.0619|0.443
71721138|NCT03037476|142958826|OTHER|General Linear Model|Slope|0.0002||||0.997|TWO_SIDED|95.0|-0.1066|0.107|||Mixed Models Analysis|Negative Binomial Regression||Change in past month alcohol typical quantity at 6 months||0.1070|-0.1066|0.997
71721139|NCT03037476|142958826|OTHER|General Linear Model|Slope|-0.0136||||0.808|TWO_SIDED|95.0|-0.1236|0.0963|||Mixed Models Analysis|Negative Binomial Regression||Change in past month typical alcohol quantity at 12 month follow-up||0.0963|-0.1236|0.808
71721140|NCT01498692|142958830|SUPERIORITY_OR_OTHER||Percent Target Lesion Failure|2.4|||<|0.0001|ONE_SIDED|95.0||7.3|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 21.1%.||7.3||<0.0001
71721141|NCT00443872|142958879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of mean group scores at baseline and 12 weeks||||<0.01
71721142|NCT00443872|142958880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71721143|NCT00443872|142958881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided||Comparison of baseline vs. 3 month circumference of the Left and Right lower leg/ankle (change identical for both legs).|Change in pedal edema as measured by change in lower leg/ankle circumference in the left and right legs||||<0.01
71721144|NCT00443872|142958882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71721145|NCT00443872|142958883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis is for the Activities of Daily Living (ADL) section of the scale||||<0.01
71721146|NCT00443872|142958883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||<|0.05|TWO_SIDED|||||This analysis is for the motor section of the UPDRS|Wilcoxon (Mann-Whitney)|||||||<0.05
71721147|NCT00443872|142958884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71721148|NCT00443872|142958885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71721149|NCT00443872|142958886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71721150|NCT00443872|142958887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71721151|NCT00135330|142958888|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||ANCOVA|||The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.||||0.282
71721152|NCT00135330|142958889|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|||||||0.004
71721153|NCT00135330|142958890|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||ANCOVA|||||||0.308
71721154|NCT00135330|142958891|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
71721155|NCT00135330|142958892|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||ANCOVA|||||||0.252
71721156|NCT00135330|142958893|SUPERIORITY_OR_OTHER|||||||0.465||95.0|||||ANCOVA|||||||0.465
71721157|NCT00135330|142958894|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||ANCOVA|||||||0.348
71721158|NCT00135330|142958898|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Mixed Model Repeated Measures (MMRM)|||||||0.039
71721159|NCT00135330|142958899|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||MMRM|||||||0.555
71721160|NCT00135330|142958901|SUPERIORITY_OR_OTHER|||||||0.106||95.0|||||MMRM|||||||0.106
71721161|NCT00135330|142958902|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||MMRM|||||||0.341
71721162|NCT00135330|142958903|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||MMRM|||||||<0.001
71721163|NCT00135330|142958904|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||MMRM|||||||0.276
71721164|NCT00135330|142958905|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||MMRM|||||||0.840
71721165|NCT00135330|142958906|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||MMRM|||||||0.096
71721166|NCT00135330|142958907|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||MMRM|||||||0.875
71887508|NCT02167945|143295852|SUPERIORITY||LS Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.91||0.035|TWO_SIDED|95.0|-3.7|-0.13|||ANCOVA||F3 - F0-F1|"F0-F1 vs F3 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.13|-3.70|0.035
71721167|NCT00135330|142958908|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|||||||0.581
71721168|NCT00135330|142958909|SUPERIORITY_OR_OTHER|||||||0.631||95.0|||||ANCOVA|||||||0.631
71721169|NCT00135330|142958910|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||ANCOVA|||||||0.724
71721170|NCT00135330|142958911|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||MMRM|||||||0.117
71721171|NCT00135330|142958912|SUPERIORITY_OR_OTHER|||||||0.251||95.0|||||MMRM|||||||0.251
71721172|NCT00135330|142958913|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||MMRM|||||||0.710
71721173|NCT00135330|142958914|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Fisher Exact|||||||0.575
71721174|NCT00135330|142958915|SUPERIORITY_OR_OTHER|||||||0.436||95.0|||||ANOVA|||||||0.436
71721175|NCT00135330|142958916|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Generalized Linear Model|||||||0.168
71721176|NCT00104416|142958932|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|31.6|||<|0.0001||95.0|15.8|48.1|||Cochran-Mantel-Haenszel|||||48.1|15.8|<0.0001
71721177|NCT01309997|142958955|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71721178|NCT01309997|142958955|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71721179|NCT03462641|142958956|SUPERIORITY||t-value|-2.15|STANDARD_DEVIATION|1.32||0.0407|TWO_SIDED|||||Alpha was set to 0.05.|Paired-Sample Two-Tailed T-Test|||Null hypothesis was no difference in PIGD score within participants before and after flumazenil infusion.||||0.0407
71721180|NCT03462641|142958956|OTHER||F-value|2.861||||0.103|TWO_SIDED|||||"P value is given for the Drug\*Time term, which represents interaction between time relative to administration (before infusion vs after infusion) and treatment administered (placebo vs flumazenil).~Alpha was set to 0.05."|Repeated Measures ANCOVA|||Null hypothesis is that there is no significant interaction between drug and time of administration (pre vs. post infusion).||||0.103
71721181|NCT03462641|142958957|OTHER||Standardized β Coefficient|0.6||||2.9e-07|TWO_SIDED|95.0|0.13|1.07||P value presented is for model comparison between interaction model and random intercept model.|Mixed Models Analysis|||A pair of maximum likelihood mixed linear models were estimated. The first was a random intercept model that merely accounted for individual differences in PIGD score before infusion. The second was an interaction model, that added an interaction term between baseline FMZ PET binding and PIGD score change from pre to post infusion. The interaction model was compared against the random intercept model to determine significance of the interaction using likelihood ratio goodness of fit test.||1.07|0.13|0.00000029
71721182|NCT03517371|142959035|SUPERIORITY||Mean Difference (Final Values)|72.35||||0.89|TWO_SIDED|95.0|-943.34|1088.04|||t-test, 2 sided|||||1088.04|-943.34|.89
71721183|NCT03517371|142959036|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.42|TWO_SIDED|95.0|-3.8|3.1|||t-test, 2 sided|||||3.10|-3.80|.42
71721184|NCT03517371|142959037|SUPERIORITY||Median Difference (Final Values)|2.17||||0.85|TWO_SIDED|95.0|-20.64|24.97|||t-test, 2 sided|Levene's test significant, equal variances not assumed values reported.||||24.97|-20.64|.85
71721185|NCT03517371|142959038|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.824|TWO_SIDED|95.0|-0.081|0.065|||t-test, 2 sided|||||.065|-.081|.824
71721186|NCT04283656|142959048|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
71721187|NCT04283656|142959049|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.66|1.32||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.32|0.66|
71721188|NCT04283656|142959050|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.76|1.24||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for doravirine C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.24|0.76|
71829718|NCT01087762|143163508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.96|-1.01||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.01|-1.96|<0.001
71887509|NCT02167945|143295852|SUPERIORITY||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|0.91||0.015|TWO_SIDED|95.0|-4.01|-0.43|||ANCOVA||F4 - F0-F1|"F0-F1 vs F4 at Post-treatment Week 24~The difference between baseline fibrosis stage groups in mean change from baseline was analyzed using ANCOVA with baseline fibrosis stage (F0-F1, F2, F3 and F4) as a factor and baseline patient reported outcomes(PRO) score and SVR12 status as covariates."||-0.43|-4.01|0.015
71887510|NCT02623335|143295862|SUPERIORITY||Odds Ratio (OR)|1.32||||0.353|TWO_SIDED||||||Mixed Models Analysis|||Options questions||||0.353
71721189|NCT04283656|142959051|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.91|1.5||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.50|0.91|
71721190|NCT04283656|142959052|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.73|2.6||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||2.60|0.73|
71769151|NCT04268823|143038464|SUPERIORITY||Least Squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.651|TWO_SIDED|80.0|-0.9|0.5|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.5|-0.9|0.651
71887511|NCT02623335|143295862|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED||||||Mixed Models Analysis|||Expectations questions||||0.923
71887512|NCT02623335|143295862|SUPERIORITY||Odds Ratio (OR)|1.41||||0.255|TWO_SIDED||||||Mixed Models Analysis|||Risks questions||||0.255
71887513|NCT02623335|143295862|SUPERIORITY||Odds Ratio (OR)|239047259.0||||0.094|TWO_SIDED||||||Mixed Models Analysis|||Advance directives questions||||0.094
71887514|NCT02623335|143295863|SUPERIORITY||Effect estimate|-0.04||||0.84|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T2 and T1||||0.84
71887515|NCT02623335|143295863|SUPERIORITY||Effect estimate|-0.15||||0.645|TWO_SIDED||||||Mixed Models Analysis|||Change in scores between T3 and T1||||0.645
71887516|NCT02623335|143295864|SUPERIORITY||Effect estimate|-0.37||||0.411|TWO_SIDED||||||Mixed Models Analysis|||||||0.411
71887517|NCT02623335|143295865|SUPERIORITY||Odds Ratio (OR)|1.39||||0.412|TWO_SIDED||||||Mixed Models Analysis|||||||0.412
71887518|NCT02623335|143295866|SUPERIORITY||Effect estimate|-0.25||||0.009|TWO_SIDED||||||Mixed Models Analysis|||||||0.009
71887519|NCT02623335|143295867|SUPERIORITY||Effect estimate|-0.72||||0.106|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.106
71887520|NCT02623335|143295867|SUPERIORITY||Effect estimate|-1.12||||0.007|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.007
71829719|NCT01087762|143163509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.38|-1.38||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.38|-2.38|<0.001
71829720|NCT01087762|143163510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.12||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.12|-2.07|<0.001
71721191|NCT04283656|142959053|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.14|||||TWO_SIDED|90.0|0.93|1.4||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment A (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate alone)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for tenofovir C24 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.40|0.93|
71721192|NCT04283656|142959054|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.7|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratio for estradiol AUC falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.70|
71721193|NCT04283656|142959055|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|0.92|1.36||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol Cmax falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.36|0.92|
71721194|NCT04283656|142959056|EQUIVALENCE|The no-effect (bioequivalence) boundaries of 80%-125% were used.|Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.88|1.35||A two-sided significance level of 0.05 with a mean ratio of 1 for no effect was assumed.||A post hoc power analysis determined 80% power would be achieved for 6 subjects to detect an effect size of 1.43 or greater at 5% significance level.|Ratio represents Treatment C (Single-dose oral doravirine/lamivudine/tenofovir disoproxil fumarate co-administered with estradiol and spironolactone) over Treatment B (Single-dose estradiol and spironolactone co-administered with placebo)|6 participants completed the study and were included in the pharmacokinetic analysis. As all participants received the same treatment groups but not necessarily in the same order, calculations were done between arms (Sequence E and F). 10 subjects was determined to achieve 80% power to reject the null hypothesis (geometric mean ratios for estradiol C12 falls outside of the no-effect boundaries) with two-sided significance level of 0.05 assuming a mean ratio of 1 for no effect.||1.35|0.88|
71721195|NCT01407952|142959057|SUPERIORITY||Odds Ratio (OR)|2.32||||0.002|TWO_SIDED|95.0|1.36|3.97|||Regression, Logistic|||A intent to treat analysis was performed, using multiple imputation methods.||3.97|1.36|0.002
71721196|NCT01407952|142959057|SUPERIORITY||Odds Ratio (OR)|3.97|||<|0.01|TWO_SIDED|95.0|1.99|7.92||Chi-squared test statistic with one degree of freedom=17.37|Chi-squared|||||7.92|1.99|<0.01
71721197|NCT01407952|142959058|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71721198|NCT01407952|142959059|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||||||0.578
71721199|NCT01407952|142959060|SUPERIORITY|||||||0.352|||||||Chi-squared|Chi-squared test statistic with one degree of freedom = 0.865||||||0.352
71721200|NCT01407952|142959061|SUPERIORITY|||||||0.769|||||||Cochran-Armitage Trend Test|||||||0.769
71721201|NCT01407952|142959062|SUPERIORITY|||||||0.641|||||||Chi-squared|Chi-square test statistic with one degree of freedom=0.217||||||0.641
71721202|NCT01407952|142959063|SUPERIORITY|||||||0.003|||||||Chi-squared|chi-square test statistic with one degree of freedom=8.82||||||0.003
71721203|NCT01407952|142959064|SUPERIORITY|||||||0.162|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=1.955||||||0.162
71887521|NCT02623335|143295868|SUPERIORITY||Effect estimate|0.97||||0.034|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.034
71657074|NCT02944383|142831654|SUPERIORITY|||||||0.4415||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.4415
71721204|NCT01407952|142959065|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
71721205|NCT01407952|142959066|SUPERIORITY||||||<|0.01|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=14.743||||||<0.01
71721206|NCT01407952|142959067|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71769152|NCT04268823|143038465|SUPERIORITY||Least Squares mean|-1.39|STANDARD_ERROR_OF_MEAN|1.29||0.288|TWO_SIDED|80.0|-3.55|0.78|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.78|-3.55|0.288
71769153|NCT04268823|143038466|SUPERIORITY||Least Squares mean|4.2|STANDARD_ERROR_OF_MEAN|4.336||0.338|TWO_SIDED|80.0|-3.09|11.48|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||11.48|-3.09|0.338
71769154|NCT04268823|143038467|SUPERIORITY||Least Squares mean|-0.82|STANDARD_ERROR_OF_MEAN|3.147||0.795|TWO_SIDED|80.0|-6.05|4.42|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Total score||4.42|-6.05|0.795
71769155|NCT04268823|143038467|SUPERIORITY||Least Squares mean|5.75|STANDARD_ERROR_OF_MEAN|4.155||0.17|TWO_SIDED|80.0|-1.16|12.66|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Symptoms score||12.66|-1.16|0.170
71769156|NCT04268823|143038467|SUPERIORITY||Least Squares mean|-0.61|STANDARD_ERROR_OF_MEAN|3.259||0.851|TWO_SIDED|80.0|-6.02|4.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Activity score||4.80|-6.02|0.851
71829721|NCT01087762|143163511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.49|-1.5||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-1.50|-2.49|<0.001
71829722|NCT01087762|143163512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.20|-0.60|<0.001
71829723|NCT01087762|143163513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.66|-0.23||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.||-0.23|-0.66|<0.001
71829724|NCT01188499|143163519|SUPERIORITY_OR_OTHER||Percent|100.0|||||TWO_SIDED||||||||Primary objective of safety and tolerability measured by percent participants experiencing at least one adverse event. No formal statistics performed.|||||
71829725|NCT01188499|143163520|SUPERIORITY_OR_OTHER||Percent|10.0|||||TWO_SIDED||||||||Percent patients overall across all five arms demonstrating complete or partial response by RECIST. No formal statistics performed.|||||
71829726|NCT00424762|143163522|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||powered to detect at least 33% difference between groups||||>0.05
71721207|NCT00935493|142959068|SUPERIORITY_OR_OTHER|||||||0.06|||||||Regression, Linear|||||||0.06
71721208|NCT00935493|142959068|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Linear|||||||0.47
71721209|NCT00935493|142959069|SUPERIORITY_OR_OTHER|||||||0.67|||||||Regression, Logistic|||||||0.67
71721210|NCT00935493|142959069|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.46
71721211|NCT00935493|142959070|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||||||0.65
71829727|NCT00424762|143163523|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||powered to detect difference of at least 10% between groups||||0.26
71829728|NCT00424762|143163524|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||comparative incidence||||0.03
71829729|NCT02311972|143163525|SUPERIORITY|Mean axillary admission temperature||||||0.7294|||||||t-test, 2 sided|||||||0.7294
71721212|NCT00935493|142959070|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
71721213|NCT02565147|142959088|SUPERIORITY|||||||0.7505|||||||Wilcoxon Rank Sum Test|||||||0.7505
71721214|NCT01104545|142959149|OTHER||Geometric mean ratio (GMR)|1.0|||||||||||||GMR = Fed/Fasted|||||
71721215|NCT01104545|142959150|OTHER||GMR|0.73|||||||||||||GMR = Fed/fasted|||||
71721216|NCT00289289|142959178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.8||0.629|ONE_SIDED|95.0||0.5||P-value is from a paired t-test since each subject had the intervention pacing features turned ON and OFF in this crossover study|t-test, 1 sided|One-sided paired t-test with 221 degrees of freedom|A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF.|Null Hypothesis: rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods when intervention pacing features ON is greater to or equal to the rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods where intervention pacing features were programmed OFF Alternative Hypothesis: rate of symptomatic AT/AF during periods of ON programming is less than the rate of symptomatic AT/AF during OFF programming||0.5||0.629
71769157|NCT04268823|143038467|SUPERIORITY||Least Squares mean|-2.07|STANDARD_ERROR_OF_MEAN|4.035||0.61|TWO_SIDED|80.0|-8.78|4.65|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Impact score||4.65|-8.78|0.610
71721217|NCT00289289|142959179|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.165|||||||Wilcoxon (Mann-Whitney)|P-value is from Koch's adaptation to the Wilcoxon Rank-Sum test comparing the within subject ON minus OFF differences to 0|A negative change means an improvement in AF symptom frequency with intervention pacing therapy programmed ON. Total possible improvement while intervention features are programmed ON is -64. Total possible worsening during ON programming is 64.|"The null hypothesis is that the symptom frequency score does not differ between while intervention pacing features were programmed ON versus OFF.~This secondary objective was not powered."||||0.165
71721218|NCT00289289|142959180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.603|TWO_SIDED|95.0|0.39|1.73||P-value is based on a repeated measures Cox proportional hazards model to the rate of AF cardioversion attempts between periods of ON and OFF programming|Regression, Cox||Hazard Ratio compares rate of first attempted cardioversion for AF while the intervention pacing features were programmed ON versus OFF.|"Null Hypothesis: AF Cardioversion attempt rate is the same during periods of ON and OFF programming~Alternative Hypothesis: AF Cardioversion attempt rate is different during periods of ON and OFF programming"||1.73|0.39|0.603
71721219|NCT00289289|142959181|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.394||95.0||||Within each randomized subject, the ON minus OFF difference in AT/AF burden was computed. The Wilcoxon Signed-Rank test was used to determine if the ON minus OFF difference in AT/AF burden was different from zero.|Wilcoxon (Mann-Whitney)||A negative median difference represents an improvement (lessening) of AT/AF burden during periods of ON versus OFF programming. A positive median difference represents an increase in AT/AF burden during ON compared to OFF programming.|Null Hypothesis: There is no difference in AT/AF burden during periods on ON and OFF programming Alternative Hypothesis: AT/AF burden is lower during periods of ON programming compared to periods of OFF programming||||0.394
71721220|NCT00940290|142959248|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Kruskal-Wallis|||After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statistic||||0.007
71721221|NCT03583359|142959264|SUPERIORITY||Difference in Responder Rate|66.8|||<|0.0001|TWO_SIDED|95.0|53.7|75.2|||Fisher's exact test|The Fisher's exact test was utilized to test the superiority of treatment (Radiesse \[+\]) over control group.|Two-sided Newcombe confidence intervals (CIs) were calculated for difference in responder rate.|||75.2|53.7|<0.0001
71721222|NCT01831466|142959270|SUPERIORITY_OR_OTHER||Difference in response rates|3.9|STANDARD_ERROR_OF_MEAN|6.36||0.5425|TWO_SIDED|80.0|-4.3|12.0|||Cochran-Mantel-Haenszel|||||12.0|-4.3|0.5425
71721223|NCT01831466|142959270|SUPERIORITY_OR_OTHER||Difference in response rates|-4.0|STANDARD_ERROR_OF_MEAN|5.87||0.4976|TWO_SIDED|80.0|-11.5|3.5|||Cochran-Mantel-Haenszel|||||3.5|-11.5|0.4976
71769158|NCT04268823|143038468|SUPERIORITY||Least Squares mean|0.25|STANDARD_ERROR_OF_MEAN|4.557||0.956|TWO_SIDED|80.0|-7.3|7.8|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough symptom score||7.80|-7.30|0.956
71769159|NCT04268823|143038468|SUPERIORITY||Least Squares mean|4.22|STANDARD_ERROR_OF_MEAN|4.671||0.369|TWO_SIDED|80.0|-3.55|11.99|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum symptom score||11.99|-3.55|0.369
71769160|NCT04268823|143038468|SUPERIORITY||Least Squares mean|2.03|STANDARD_ERROR_OF_MEAN|4.001||0.613|TWO_SIDED|80.0|-4.61|8.68|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Cough impact score||8.68|-4.61|0.613
71769161|NCT04268823|143038468|SUPERIORITY||Least Squares mean|0.94|STANDARD_ERROR_OF_MEAN|4.518||0.835|TWO_SIDED|80.0|-6.58|8.47|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|Sputum impact score||8.47|-6.58|0.835
71769162|NCT04268823|143038470|SUPERIORITY||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.335|TWO_SIDED|80.0|0.0|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|0.0|0.335
71769163|NCT04268823|143038471|SUPERIORITY||Least Squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.645|TWO_SIDED|80.0|-0.1|0.1|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||0.1|-0.1|0.645
71769164|NCT04268823|143038472|SUPERIORITY||Least Squares mean|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED|80.0|0.8|3.4|||Mixed effects Model for Repeated Measure||Treatment difference (QBW251-placebo)|||3.4|0.8|0.010
71829730|NCT02311972|143163526|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.2360
71829731|NCT02311972|143163527|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71721224|NCT01831466|142959270|SUPERIORITY_OR_OTHER||Difference in response rates|3.3|STANDARD_ERROR_OF_MEAN|6.36||0.6039|TWO_SIDED|80.0|-4.9|11.5|||Cochran-Mantel-Haenszel|||||11.5|-4.9|0.6039
71721225|NCT01831466|142959270|SUPERIORITY_OR_OTHER||Difference in response rate|4.0|STANDARD_ERROR_OF_MEAN|6.34||0.5279|TWO_SIDED|80.0|-4.1|12.1|||Cochran-Mantel-Haenszel|||||12.1|-4.1|0.5279
71721226|NCT01831466|142959271|SUPERIORITY_OR_OTHER||Difference in response rates|10.8|STANDARD_ERROR_OF_MEAN|5.99||0.071|TWO_SIDED|80.0|3.1|18.5|||Cochran-Mantel-Haenszel|||||18.5|3.1|0.0710
71721227|NCT01831466|142959271|SUPERIORITY_OR_OTHER||Difference in response rates|-1.2|STANDARD_ERROR_OF_MEAN|5.2||0.8175|TWO_SIDED|80.0|-7.9|5.5|||Cochran-Mantel-Haenszel|||||5.5|-7.9|0.8175
71721228|NCT01831466|142959271|SUPERIORITY_OR_OTHER||Difference in response rates|11.0|STANDARD_ERROR_OF_MEAN|5.63||0.0513|TWO_SIDED|80.0|3.8|18.2|||Cochran-Mantel-Haenszel|||||18.2|3.8|0.0513
71721229|NCT01831466|142959271|SUPERIORITY_OR_OTHER||Difference in response rates|6.7|STANDARD_ERROR_OF_MEAN|5.23||0.2021|TWO_SIDED|80.0|0.0|13.4|||Cochran-Mantel-Haenszel|||||13.4|-0.0|0.2021
71721230|NCT03122145|142959301|SUPERIORITY|Mann whitney U between groups comparison for voluntary cough parameters between healthy controls and individuals with ALS outcomes: peak expiratory cough flow and cough volume acceleration||||||0.0005|||||||ANOVA|||Hypothesis that voluntary cough \> reflex cough strength and effectiveness in healthy volunteers||||0.0005
71721231|NCT01597908|142959303|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.58|0.83|||||Hazard ratios are estimated using a Pike estimator.|||0.83|0.58|
71721232|NCT01597908|142959304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.52|0.73|||||Hazard ratios are estimated using a Pike estimator.|||0.73|0.52|
71721233|NCT01597908|142959306|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.51|0.81||||||||0.81|0.51|
71721234|NCT04114071|142959315|EQUIVALENCE|An independent sample t tests was used to examine the difference score for each of the four outcome measures of interest (steps, WC, weight, and HbA1c) between intervention and control groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71721235|NCT01659996|142959316|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was \< δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.11|||||TWO_SIDED|95.0|-3.11|2.93||||||Meningococcal serogroup A: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||2.93|-3.11|
71721236|NCT01659996|142959316|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.27|||||TWO_SIDED|95.0|-0.84|3.64||||||Meningococcal serogroup C: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.64|-0.84|
71721237|NCT01659996|142959316|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|2.46|||||TWO_SIDED|95.0|0.14|5.14||||||Meningococcal serogroup Y: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||5.14|0.14|
71721238|NCT01659996|142959316|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.28|||||TWO_SIDED|95.0|-0.84|3.67||||||Meningococcal serogroup W-135: The null hypothesis (H0: pm - ppm \> δ) was tested against the alternative hypothesis (H1: pm - ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.||3.67|-0.84|
71721239|NCT01659996|142959321|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.949|||||TWO_SIDED|95.0|0.852|1.06||||||Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively||1.06|0.852|
71721240|NCT01659996|142959321|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.968|||||TWO_SIDED|95.0|0.866|1.08||||||Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively||1.08|0.866|
71721241|NCT01659996|142959321|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|1.11|||||TWO_SIDED|95.0|0.937|1.31||||||Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm \> 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively||1.31|0.937|
71829732|NCT02311972|143163528|SUPERIORITY|||||||0.1089|||||||t-test, 2 sided|||||||0.1089
71721242|NCT01659996|142959322|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-1.22|||||TWO_SIDED|95.0|-5.44|3.19||||||Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.||3.19|-5.44|
71721243|NCT01659996|142959322|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|0.867|||||TWO_SIDED|95.0|-2.54|4.53||||||Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.||4.53|-2.54|
71721244|NCT01659996|142959322|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the two-sided 95% CI of the difference between the two proportions was \< δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.092|||||TWO_SIDED|95.0|-3.62|3.66||||||Pertactin (PRN) antigen: The null hypothesis (H0: pp - ppm \> δ) was tested against the alternative hypothesis (H1: pp - ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.||3.66|-3.62|
71721245|NCT00475085|142959337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013||||0.718|TWO_SIDED|95.0|-0.225|0.2||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 2 (palonosetron vs. granisetron)||0.200|-0.225|0.718
71829733|NCT02311972|143163529|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71829734|NCT02311972|143163530|SUPERIORITY|||||||0.4947|||||||t-test, 2 sided|||||||0.4947
71887522|NCT02623335|143295868|SUPERIORITY||Effect estimate|1.12||||0.019|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment (T3)||||0.019
71721246|NCT00475085|142959337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195||||0.01|TWO_SIDED|95.0|-0.017|0.407||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 4 (adding dexamethasone)||0.407|-0.017|0.010
71721247|NCT00475085|142959337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.557|TWO_SIDED|95.0|-0.236|0.186||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 3 - Group 4 (aprepitant vs. prochlorperazine)||0.186|-0.236|0.557
71721248|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.505|TWO_SIDED|95.0|0.24|2.03|||Unstratified log-rank|||||2.03|0.24|0.5050
71721249|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.6284|TWO_SIDED|95.0|0.22|2.54|||Unstratified log-rank|||||2.54|0.22|0.6284
71721250|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1988|TWO_SIDED|95.0|0.4|1.22|||Unstratified log-rank|||||1.22|0.40|0.1988
71829735|NCT02311972|143163531|SUPERIORITY|Infant 007|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71721251|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2722|TWO_SIDED|95.0|0.42|1.28|||Unstratified log-rank|||||1.28|0.42|0.2722
71721252|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0544|TWO_SIDED|95.0|0.17|1.04|||Unstratified log-rank|||||1.04|0.17|0.0544
71721253|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|2.04||||0.0442|TWO_SIDED|95.0|1.0|4.16|||Unstratified log-rank|||||4.16|1.00|0.0442
71721254|NCT02574078|142959435|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5489|TWO_SIDED|95.0|0.5|1.45|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.45|0.50|0.5489
71657075|NCT02944383|142831654|SUPERIORITY|||||||0.7902||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.7902
71721255|NCT02574078|142959436|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9951|TWO_SIDED|95.0|0.35|2.91|||Unstratified log-rank|||||2.91|0.35|0.9951
71721256|NCT02574078|142959436|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.8321|TWO_SIDED|95.0|0.25|3.1|||Unstratified log-rank|||||3.10|0.25|0.8321
71721257|NCT02574078|142959436|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2938|TWO_SIDED|95.0|0.41|1.31|||Unstratified log-rank|||||1.31|0.41|0.2938
71721258|NCT02574078|142959436|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4819|TWO_SIDED|95.0|0.46|1.45|||Unstratified log-rank|||||1.45|0.46|0.4819
71721259|NCT02574078|142959436|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0241|TWO_SIDED|95.0|0.11|0.91|||Unstratified log-rank|||||0.91|0.11|0.0241
71829736|NCT02311972|143163531|SUPERIORITY|Infant 010|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71721260|NCT02574078|142959436|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.1401|TWO_SIDED|95.0|0.85|2.95|||Unstratified log-rank|||||2.95|0.85|0.1401
71721261|NCT02574078|142959440|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.2862|TWO_SIDED|95.0|0.4|1.31|||Log Rank|stratified by Disease Status (Recurrent Locally Advanced vs. Metastatic), Performance Status (ECOG 0 vs.1 vs. 2) as entered into the IVRS||||1.31|0.40|0.2862
71721262|NCT00301262|142959452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.13|STANDARD_ERROR_OF_MEAN|3.405|<|0.0001||95.0|11.4|24.86||Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.|ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.||24.86|11.40|<0.0001
71721263|NCT00301262|142959453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|14.761||0.0028||95.0|1.8|8.37|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||8.370|1.800|0.0028
71721264|NCT00301262|142959453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.02|STANDARD_DEVIATION|22.294|<|0.0001||95.0|20.58|31.455|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||31.455|20.580|<0.0001
71721265|NCT00301262|142959454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.656||0.008||95.0|0.47|3.06|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||3.06|0.47|0.0080
71721266|NCT00301262|142959455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.94|STANDARD_DEVIATION|2.909||0.0051||95.0|0.29|1.585|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.585|0.290|0.0051
71721267|NCT00301262|142959455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|4.013|<|0.0001||95.0|1.812|3.77|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.770|1.812|<0.0001
71721268|NCT00301262|142959456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|0.922||0.0054||95.0|0.78|4.43|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.43|0.78|0.0054
71829737|NCT02311972|143163531|SUPERIORITY|Infant 015|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71829738|NCT02311972|143163531|SUPERIORITY|Infant 039|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71829739|NCT02311972|143163531|SUPERIORITY|Infant 040||||||0.3947|||||||t-test, 2 sided|||||||0.3947
71829740|NCT03557658|143163541|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate|106.22|||||TWO_SIDED|90.0|78.34|144.02|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group.||144.02|78.34|
71721269|NCT00301262|142959457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.368||0.4232||95.0|-0.43|1.02|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.02|-0.43|0.4232
71887523|NCT02623335|143295869|SUPERIORITY||Effect estimate|1.16||||0.022|TWO_SIDED||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)||||0.022
71721270|NCT00301262|142959458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.277||0.0156||95.0|0.13|1.22|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.22|0.13|0.0156
71721271|NCT00301262|142959459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.458||0.0096||95.0|0.3|2.11|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||2.11|0.30|0.0096
71721272|NCT00301262|142959460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.359||0.0135||95.0|0.19|1.61|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||1.61|0.19|0.0135
71721273|NCT00301262|142959461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|4.392||0.0033||95.0|0.051|2.465|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.465|0.0510|0.0033
71721274|NCT00301262|142959461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.22|STANDARD_DEVIATION|6.346|<|0.0001||95.0|3.676|6.772|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||6.772|3.676|<0.0001
71721275|NCT00301262|142959462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.57||0.2581||95.0|-0.149|0.549|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.549|-0.149|0.2581
71721276|NCT00301262|142959462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39|STANDARD_DEVIATION|2.582|<|0.0001||95.0|0.758|2.018|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.018|0.758|<0.0001
71721277|NCT00301262|142959463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18|STANDARD_DEVIATION|1.456||0.2857||95.0|-0.149|0.499|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.499|-0.149|0.2857
71721278|NCT00301262|142959463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.76|STANDARD_DEVIATION|1.706||0.0005||95.0|0.345|1.177|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.177|0.345|0.0005
71721279|NCT00301262|142959464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|2.548||0.0102||95.0|0.183|1.317|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.317|0.183|0.0102
71721280|NCT00301262|142959464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|2.979|<|0.0001||95.0|1.557|3.01|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.010|1.557|<0.0001
71721281|NCT00301262|142959465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.847||0.0016||95.0|0.264|1.086|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.086|0.264|0.0016
71721282|NCT00301262|142959465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.9|STANDARD_DEVIATION|2.297|<|0.0001||95.0|1.335|2.456|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.456|1.335|<0.0001
71721283|NCT00301262|142959466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.78|STANDARD_ERROR_OF_MEAN|1.038||0.0083||95.0|0.73|4.83|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||4.83|0.73|0.0083
71721284|NCT00301262|142959467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|5.193||0.9146||95.0|-1.218|1.093|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.093|-1.218|0.9146
71721285|NCT00301262|142959467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.54|STANDARD_DEVIATION|6.463|<|0.0001||95.0|3.961|7.114|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||7.114|3.961|<0.0001
71721286|NCT00301262|142959468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.42|STANDARD_ERROR_OF_MEAN|4.826||0.0002||95.0|8.88|27.96|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|||27.96|8.88|0.0002
71721287|NCT00301262|142959469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.41|STANDARD_DEVIATION|20.444||0.0064||95.0|1.857|10.956|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||10.956|1.857|0.0064
71721288|NCT00301262|142959469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|26.8|STANDARD_DEVIATION|29.384|<|0.0001|TWO_SIDED|95.0|19.636|33.971|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||33.971|19.636|<0.0001
71721289|NCT00301262|142959470|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.491||||0.0001||95.0|3.042|13.851|||Regression, Logistic|||||13.851|3.042|0.0001
71721290|NCT00301262|142959471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.915|||<|0.0001||95.0|2.396|10.08|||Regression, Logistic|||||10.080|2.396|<0.0001
71721291|NCT00301262|142959472|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.676||||0.0187||95.0|1.242|10.875|||Regression, Logistic|||||10.875|1.242|0.0187
71721292|NCT00301262|142959473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.9|STANDARD_ERROR_OF_MEAN|4.716||0.0037||95.0|4.59|23.22|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.22|4.59|0.0037
71721293|NCT00301262|142959474|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.72|STANDARD_ERROR_OF_MEAN|4.496||0.0321||95.0|0.84|18.6|||independent-samples t-test||Mean Difference = Week 8 - Baseline|||18.60|0.84|0.0321
71721294|NCT00301262|142959475|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.97|STANDARD_ERROR_OF_MEAN|3.901||0.0427||95.0|-15.68|-0.27|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-0.27|-15.68|0.0427
71721295|NCT00301262|142959476|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|3.903||0.0533||95.0|-15.32|0.11|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.11|-15.32|0.0533
71721296|NCT00301262|142959477|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.167|STANDARD_ERROR_OF_MEAN|0.3041||0.0002||95.0|0.566|1.768|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.768|0.566|0.0002
71721297|NCT00301262|142959478|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.4454|STANDARD_ERROR_OF_MEAN|0.3638||0.0001||95.0|0.727|2.164|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||2.164|0.727|0.0001
71721298|NCT00301262|142959479|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.1821|STANDARD_ERROR_OF_MEAN|0.3946||0.0032||95.0|0.403|1.961|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.961|0.403|0.0032
71721299|NCT00301262|142959480|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2123|STANDARD_ERROR_OF_MEAN|0.3549||0.0008||95.0|0.511|1.913|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).|||1.913|0.511|0.0008
71721300|NCT00301262|142959481|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.454||0.0195||95.0|0.064|0.711|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.711|0.064|0.0195
71721301|NCT00301262|142959481|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.09|STANDARD_DEVIATION|2.207|<|0.0001||95.0|1.551|2.628|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.628|1.551|<0.0001
71721302|NCT00301262|142959482|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|1.489||0.0186||95.0|0.069|0.731|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.731|0.069|0.0186
71657076|NCT02944383|142831654|SUPERIORITY|||||||0.6999||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.6999
71721303|NCT00301262|142959482|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.67|STANDARD_DEVIATION|2.573|<|0.0001||95.0|2.044|3.299|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.299|2.044|<0.0001
71721304|NCT00301262|142959483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_DEVIATION|1.917||0.0033||95.0|0.223|1.077|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||1.077|0.223|0.0033
71721305|NCT00301262|142959483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.61|STANDARD_DEVIATION|2.335|<|0.0001||95.0|2.042|3.182|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||3.182|2.042|<0.0001
71721306|NCT00301262|142959484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.45|STANDARD_DEVIATION|1.606||0.0143||95.0|0.093|0.807|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||0.807|0.093|0.0143
71721307|NCT00301262|142959484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.99|STANDARD_DEVIATION|2.178|<|0.0001||95.0|1.454|2.516|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).|||2.516|1.454|<0.0001
71721308|NCT00301262|142959485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0325
71721309|NCT00301262|142959485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
71721310|NCT00301262|142959486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0196
71657077|NCT02944383|142831654|SUPERIORITY|||||||0.0015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0015
71721311|NCT00301262|142959486|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||<0.0001
71721312|NCT00301262|142959487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.3173
71721313|NCT00301262|142959487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.||||0.0016
71721314|NCT00301262|142959488|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.55|STANDARD_ERROR_OF_MEAN|2.958||0.0624||95.0|-11.39|0.29|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.29|-11.39|0.0624
71721315|NCT00301262|142959488|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|1.835||0.4523||95.0|-2.24|5.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.01|-2.24|0.4523
71721316|NCT00301262|142959489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.48|STANDARD_ERROR_OF_MEAN|1.962||0.2081||95.0|-6.35|1.4|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.40|-6.35|0.2081
71887524|NCT02623335|143295869|SUPERIORITY||Effect estimate|0.94||||0.053|TWO_SIDED||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)||||0.053
71721317|NCT00301262|142959489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.61|STANDARD_ERROR_OF_MEAN|1.958||0.4131||95.0|-2.26|5.48|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.48|-2.26|0.4131
71721318|NCT00301262|142959490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|2.126||0.4069||95.0|-5.97|2.43|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||2.43|-5.97|0.4069
71721319|NCT00301262|142959490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.489||0.1137||95.0|-0.57|5.31|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.31|-0.57|0.1137
71721320|NCT00301262|142959491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.23|STANDARD_ERROR_OF_MEAN|4.829||0.0123||95.0|-21.77|-2.7|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||-2.70|-21.77|0.0123
71721321|NCT00301262|142959491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|4.883||0.8993||95.0|-10.27|9.03|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.03|-10.27|0.8993
71721322|NCT00301262|142959492|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.03|STANDARD_ERROR_OF_MEAN|5.458|<|0.0001||95.0|11.25|32.81|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||32.81|11.25|<0.0001
71721323|NCT00301262|142959492|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.74|STANDARD_ERROR_OF_MEAN|5.818||0.4165||95.0|-16.24|6.76|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||6.76|-16.24|0.4165
71721324|NCT00301262|142959493|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.8|STANDARD_ERROR_OF_MEAN|4.351||0.0257||95.0|1.21|18.39|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||18.39|1.21|0.0257
71721325|NCT00301262|142959493|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.36|STANDARD_ERROR_OF_MEAN|3.209||0.0971||95.0|-11.7|0.98|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.98|-11.70|0.0971
71721326|NCT00301262|142959494|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.754||0.0726||95.0|-6.66|0.3|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||0.30|-6.66|0.0726
71721327|NCT00301262|142959494|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|1.798||0.2581||95.0|-5.61|1.52|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||1.52|-5.61|0.2581
71721328|NCT00301262|142959495|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|4.45||0.8158||95.0|-9.86|7.78|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.78|-9.86|0.8158
71721329|NCT00301262|142959495|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.692||0.8464||95.0|-3.68|3.02|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||3.02|-3.68|0.8464
71721330|NCT00301262|142959496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|5.789||0.9529||95.0|-11.82|11.13|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||11.13|-11.82|0.9529
71721331|NCT00301262|142959496|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|4.994||0.8899||95.0|-10.59|9.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||9.20|-10.59|0.8899
71721332|NCT00301262|142959497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.18|STANDARD_ERROR_OF_MEAN|7.897||0.2001||95.0|-25.83|5.47|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||5.47|-25.83|0.2001
71721333|NCT00301262|142959497|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.68|STANDARD_ERROR_OF_MEAN|6.724||0.1527||95.0|-3.64|23.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||23.01|-3.64|0.1527
71721334|NCT00301262|142959498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_ERROR_OF_MEAN|7.774||0.0606||95.0|-0.67|30.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||30.15|-0.67|0.0606
71721335|NCT00301262|142959498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.62|STANDARD_ERROR_OF_MEAN|7.318||0.3678||95.0|-21.12|7.88|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||7.88|-21.12|0.3678
71721336|NCT00301262|142959499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|7.474||0.5429||95.0|-10.25|19.37|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||19.37|-10.25|0.5429
71887525|NCT02623335|143295871|SUPERIORITY||Effect estimate|5.04||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71657078|NCT02944383|142831654|SUPERIORITY|||||||0.0796||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0796
71887526|NCT01046695|143295885|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||Decrease in OME use in the TENS Unit during the first and second 24 hours.||||.005
71721337|NCT00301262|142959499|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.07|STANDARD_ERROR_OF_MEAN|5.595||0.5849||95.0|-8.02|14.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||14.15|-8.02|0.5849
71721338|NCT00301262|142959500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.86|STANDARD_ERROR_OF_MEAN|4.952||0.0002||95.0|9.08|28.64|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||28.64|9.08|0.0002
71721339|NCT00301262|142959500|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|6.212||0.429||95.0|-7.35|17.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.|||17.20|-7.35|0.4290
71721340|NCT00368745|142959501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2838||95.0||||significance determined using 2-tailed significance level of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with country as a covariate||Primary objective: evaluate the efficacy of pregabalin in maintaining the benzodiazepine free state in subjects with prior stable alprazolam use.||||0.2838
71721341|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.81||0.0709||95.0|-3.1|0.13||contrasts performed using Dunnett's Test|ANCOVA|Least squares (LS) Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||0.13|-3.10|0.0709
71721342|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|1.08||0.0006||95.0|-6.04|-1.74||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-1.74|-6.04|0.0006
71721343|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.3||0.0718||95.0|-4.98|0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.22|-4.98|0.0718
71721344|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.38|STANDARD_ERROR_OF_MEAN|1.92||0.092||95.0|-7.37|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.60|-7.37|0.0920
71721345|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|3.04||0.1371||95.0|-12.67|2.23||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT week 5||2.23|-12.67|0.1371
71721346|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.04||0.0882||95.0|-7.96|0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.61|-7.96|0.0882
71721347|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|STANDARD_ERROR_OF_MEAN|1.11||0.0135||95.0|-5.05|-0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.61|-5.05|0.0135
71721348|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.18||0.3924||95.0|-3.38|1.35||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||1.35|-3.38|0.3924
71721349|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.14||0.3868||95.0|-3.29|1.3||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||1.30|-3.29|0.3868
71721350|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.15||0.9966||95.0|-2.31|2.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||2.32|-2.31|0.9966
71721351|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.26||0.6873||95.0|-3.07|2.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||2.05|-3.07|0.6873
71721352|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.35||0.5337||95.0|-3.62|1.91||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||1.91|-3.62|0.5337
71721353|NCT00368745|142959502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.79|STANDARD_ERROR_OF_MEAN|1.37||0.0008||95.0|-7.51|-2.07||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-2.07|-7.51|0.0008
71721354|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|1.4||0.122||95.0|-4.97|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.60|-4.97|0.1220
71721355|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.63|STANDARD_ERROR_OF_MEAN|1.26||0.0053||95.0|-6.15|-1.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-1.11|-6.15|0.0053
71721356|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|1.73||0.1048||95.0|-6.32|0.62||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.62|-6.32|0.1048
71721357|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.52||0.0357||95.0|-6.57|-0.25||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||-0.25|-6.57|0.0357
71887527|NCT01046695|143295885|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||Decrease in OME use in the Control Arm during the first and second 24 hours.||||.11
71887528|NCT01046695|143295886|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||t-test, 2 sided|||||||.70
71721358|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|2.67||0.4263||95.0|-8.82|4.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||4.26|-8.82|0.4263
71721359|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.73|STANDARD_ERROR_OF_MEAN|2.02||0.0104||95.0|-9.96|-1.51||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||-1.51|-9.96|0.0104
71769165|NCT02519855|143038481|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported a conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.95|||Longitudinal regression model|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||0.95|0.80|<0.001
71769166|NCT02519855|143038482|SUPERIORITY_OR_OTHER||GMFR from Baseline|1.9|||<|0.001|TWO_SIDED|95.0|1.76|2.05||A lower bound of the 95% CI on the GMFR \> 1.4 indicated that the Concomitant Group induces an acceptable VZV antibody response. A p-value ≤0.025 also supported this conclusion.|Longitudinal regression||Estimated GMFR, 95% CI and p-value were based on a longitudinal regression model adjusting for age.|||2.05|1.76|<0.001
71769167|NCT02519855|143038483|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.18|0.88|<0.001
71769168|NCT02519855|143038484|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.1|||<|0.001|TWO_SIDED|95.0|0.94|1.29|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.29|0.94|<0.001
71769169|NCT02519855|143038485|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.14|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.14|0.88|<0.001
71721360|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.4||0.0069||95.0|-6.73|-1.12||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-1.12|-6.73|0.0069
71721361|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|1.37||0.2185||95.0|-4.47|1.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||1.05|-4.47|0.2185
71769170|NCT02519855|143038486|NON_INFERIORITY_OR_EQUIVALENCE|A lower bound of the 95% CI on the fold difference (GMT ratio \[Concomitant / Nonconcomitant\] at 4 weeks postvaccination) \>0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.99|||<|0.001|TWO_SIDED|95.0|0.87|1.13|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.||||1.13|0.87|<0.001
71769171|NCT02415842|143038637|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.12|||||TWO_SIDED|95.0|0.73|1.72|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.72|0.73|
71769172|NCT02415842|143038637|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.23|||||TWO_SIDED|95.0|0.83|1.81|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.81|0.83|
71769173|NCT02415842|143038637|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1\_AS over H1N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|0.88|||||TWO_SIDED|95.0|0.63|1.24|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.24|0.63|
71829741|NCT03557658|143163541|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|110.84|||||TWO_SIDED|90.0|75.34|163.06|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||163.06|75.34|
71721362|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.06||0.7832||95.0|-2.41|1.83||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||1.83|-2.41|0.7832
71829742|NCT03557658|143163544|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|128.34|||||TWO_SIDED|90.0|99.98|164.73|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for total bexagliflozin by hepatic function group||164.73|99.98|
71721363|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.16||0.7062||95.0|-1.9|2.79||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||2.79|-1.90|0.7062
71721364|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.04||0.7161||95.0|-2.49|1.73||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||1.73|-2.49|0.7161
71769174|NCT02415842|143038638|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 21 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.66|||||TWO_SIDED|95.0|1.12|2.47|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.47|1.12|
71769175|NCT02415842|143038638|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|2.16|||||TWO_SIDED|95.0|1.54|3.03|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||3.03|1.54|
71769176|NCT02415842|143038638|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.95|||||TWO_SIDED|95.0|1.49|2.54|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.54|1.49|
71769177|NCT02415842|143038638|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1\_AS over H5N1\_NAS) at Day 385 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.63|||||TWO_SIDED|95.0|1.32|2.01|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||2.01|1.32|
71769178|NCT02415842|143038639|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.39|||||TWO_SIDED|95.0|1.14|1.69|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.69|1.14|
71769179|NCT02415842|143038639|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.49|||||TWO_SIDED|95.0|1.28|1.73|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.73|1.28|
71721365|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|1.43||0.0376||95.0|-6.03|-0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.19|-6.03|0.0376
71721366|NCT00368745|142959505|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.48||0.0122||95.0|-6.74|-0.85||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.85|-6.74|0.0122
71769180|NCT02415842|143038639|EQUIVALENCE|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2\_AS over H9N2\_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.2|||||TWO_SIDED|95.0|1.0|1.44|||ANCOVA|ANCOVA model on logarithm10 transformation of concentration, with vaccine group as fixed effect and anti- H1 stalk ELISA result at Day 0 as covariates||||1.44|1.00|
71769181|NCT02415842|143038640|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|10.79|||||TWO_SIDED|95.0|-16.5|36.83|||Asymptotic standardized 95% CI|||||36.83|-16.50|
71769182|NCT02415842|143038640|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|12.0|||||TWO_SIDED|95.0|-14.45|36.98|||Asymptotic standardized 95% CI|||||36.98|-14.45|
71769183|NCT02415842|143038640|EQUIVALENCE|Difference between groups (H1N1\_AS minus H1N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|-6.07|||||TWO_SIDED|95.0|-30.56|18.65|||Asymptotic standardized 95% CI|||||18.65|-30.56|
71769184|NCT02415842|143038641|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|27.08|||||TWO_SIDED|95.0|5.96|47.01|||Asymptotic standardized 95% CI|||||47.01|5.96|
71769185|NCT02415842|143038641|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|36.65|||||TWO_SIDED|95.0|11.41|57.53|||Asymptotic standardized 95% CI|||||57.53|11.41|
71769186|NCT02415842|143038641|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|6.39|||||TWO_SIDED|95.0|-11.91|24.71|||Asymptotic standardized 95% CI|||||24.71|-11.91|
71769187|NCT02415842|143038641|EQUIVALENCE|Difference between groups (H5N1\_AS minus H5N1\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 365.|Difference in percentage of subjects|6.9|||||TWO_SIDED|95.0|-6.19|22.15|||Asymptotic standardized 95% CI|||||22.15|-6.19|
71829743|NCT03557658|143163544|EQUIVALENCE|The acceptance range for bioequivalence is 80.00 - 125.00%.|Point Estimate|132.16|||||TWO_SIDED|90.0|96.46|181.08|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with hepatic function group as a fixed effect, and the subject as a random effect.|Geometric LS Mean was used as PK parameters for unbound bexagliflozin by hepatic function group||181.08|96.46|
71829744|NCT01667796|143163613|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||univariate generalized estimating equati|||||||0.001
71829745|NCT01667796|143163613|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Adjusted for adherence, body mass index, and oral contraceptive use|Generalized estimating equation|||||||0.008
71769188|NCT02415842|143038642|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|3.33|||||TWO_SIDED|95.0|-13.06|20.24|||Asymptotic standardized 95% CI|||||20.24|-13.06|
71769189|NCT02415842|143038642|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|16.67|||||TWO_SIDED|95.0|0.35|34.76|||Asymptotic standardized 95% CI|||||34.76|0.35|
71769190|NCT02415842|143038642|EQUIVALENCE|Difference between groups (H9N2\_AS minus H9N2\_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|0.24|||||TWO_SIDED|95.0|-13.76|15.0|||Asymptotic standardized 95% CI|||||15.00|-13.76|
71769191|NCT02057042|143038668|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71769192|NCT02057042|143038669|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71769193|NCT02057042|143038670|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71769194|NCT02057042|143038671|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71769195|NCT02057042|143038672|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71769196|NCT02057042|143038673|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71769197|NCT02882152|143038686|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
71769198|NCT02882152|143038687|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"||||<0.05
71769199|NCT03739242|143038689|SUPERIORITY||Least Square Mean difference|-39.16|||<|0.0001|TWO_SIDED|95.0|-48.57|-29.75|||ANCOVA|||||-29.75|-48.57|<0.0001
71769200|NCT03739242|143038690|SUPERIORITY||Least Square Mean difference|-41.24||||0.0001|TWO_SIDED|95.0|-51.73|-30.74|||ANCOVA|||||-30.74|-51.73|0.0001
71769201|NCT03739242|143038691|SUPERIORITY||Least Square Mean difference|0.09||||0.951|TWO_SIDED|95.0|-2.87|3.05|||ANCOVA|||||3.05|-2.87|0.9510
71769202|NCT03739242|143038692|SUPERIORITY||Least Square Mean difference|-41.7|||<|0.0001|TWO_SIDED|95.0|-51.58|-31.82|||ANCOVA|||||-31.82|-51.58|<0.0001
71769203|NCT03739242|143038693|SUPERIORITY||Least Square Mean difference|-7.0||||0.1924|TWO_SIDED|95.0|-17.59|3.59|||ANCOVA|||||3.59|-17.59|0.1924
71769204|NCT03739242|143038694|SUPERIORITY||Least Square Mean difference|-17.26|||<|0.0001|TWO_SIDED|95.0|-23.54|-10.98|||ANCOVA|||||-10.98|-23.54|<0.0001
71769205|NCT03739242|143038695|SUPERIORITY||Least Square Mean difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.62|||ANCOVA|||||-0.62|-1.19|<0.0001
71769206|NCT03739242|143038696|SUPERIORITY||Least Square Mean difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.05|-0.59|||ANCOVA|||||-0.59|-1.05|<0.0001
71829746|NCT00385801|143163714|SUPERIORITY_OR_OTHER|||||||0.86||||||The effect of treatment on intensity of craving was assessed and the threshold for statistical significance was p \< 0.05|Mixed Models Analysis|F=0.03||Intensity of craving||||0.86
71829747|NCT03603717|143163725|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71829748|NCT03603717|143163726|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71769207|NCT03739242|143038697|SUPERIORITY||Least Square Mean difference|-3.47||||0.4535|TWO_SIDED|95.0|-12.64|5.7|||ANCOVA|||||5.7|-12.64|0.4535
71829749|NCT03603717|143163727|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
71769208|NCT03739242|143038698|SUPERIORITY||Least Square Mean difference|0.74||||0.5594|TWO_SIDED|95.0|-1.76|3.24|||ANCOVA|||||3.24|-1.76|0.5594
71769209|NCT03739242|143038699|SUPERIORITY||Least Square Mean difference|-0.07||||0.9266|TWO_SIDED|95.0|-1.63|1.48|||ANCOVA|||||1.48|-1.63|0.9266
71769210|NCT03739242|143038700|SUPERIORITY||Least Square Mean difference|6.02||||0.2654|TWO_SIDED|95.0|-4.66|16.69|||ANCOVA|||||16.69|-4.66|0.2654
71769211|NCT03739242|143038701|SUPERIORITY||Least Square Mean difference|-5.95||||0.2595|TWO_SIDED|95.0|-16.37|4.47|||ANCOVA|||||4.47|-16.37|0.2595
71769212|NCT03739242|143038702|SUPERIORITY||Least Square Mean difference|0.003||||0.8476|TWO_SIDED|95.0|-0.039|0.032|||ANCOVA|||||0.032|-0.039|0.8476
71769213|NCT03739242|143038703|SUPERIORITY||Least Square Mean difference|-0.21||||0.1499|TWO_SIDED|95.0|-0.49|0.08|||ANCOVA|||||0.08|-0.49|0.1499
71769214|NCT03739242|143038704|SUPERIORITY||Least Square Mean difference|1.71||||0.7224|TWO_SIDED|95.0|-7.83|11.25|||ANCOVA|||||11.25|-7.83|0.7224
71769215|NCT01475071|143038729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority margin of -10%|Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|15.6||0.0345|ONE_SIDED|95.0|-6.8||||paired Student's t statistic|||The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.|||-6.8|0.0345
71769216|NCT01475071|143038730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_DEVIATION|2.7|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided Wilcoxon rank signed||superiority of Metvix adaylight and Metvix Lamp in term of pain||||<0.001
71769217|NCT01437995|143038763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.3|0.69|1.65||||||||1.65|0.69|
71769218|NCT01437995|143038764|SUPERIORITY_OR_OTHER|||||||0.43|||||||Kruskal-Wallis|||||||0.43
71769219|NCT01437995|143038764|SUPERIORITY_OR_OTHER|||||||0.022|||||||Kruskal-Wallis|||||||0.022
71769220|NCT01437995|143038764|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71769221|NCT01437995|143038765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.41||||||||1.41|0.63|
71769222|NCT01437995|143038765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.8|1.73||||||||1.73|0.80|
71769223|NCT01437995|143038765|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.83|1.81||||||||1.81|0.83|
71769224|NCT01437995|143038766|SUPERIORITY_OR_OTHER|||||||0.15|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.15
71769225|NCT01437995|143038766|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||<0.001
71769226|NCT01437995|143038766|SUPERIORITY_OR_OTHER|||||||0.027|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1||||0.027
71829750|NCT03603717|143163728|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71721367|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0052||95.0|-0.76|-0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1||-0.14|-0.76|0.0052
71721368|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.18||0.0001||95.0|-1.11|-0.38||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2||-0.38|-1.11|0.0001
71721369|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0528||95.0|-1.0|0.01||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3||0.01|-1.00|0.0528
71721370|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.35||0.3085||95.0|-1.11|0.37||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4||0.37|-1.11|0.3085
71721371|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.47||0.1807||95.0|-1.92|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 5||0.47|-1.92|0.1807
71721372|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.42||0.1074||95.0|-1.58|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6||0.17|-1.58|0.1074
71721373|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0013||95.0|-1.1|-0.28||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1||-0.28|-1.10|0.0013
71721374|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0503||95.0|-0.99|0.0||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2||0.00|-0.99|0.0503
71721375|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.26||0.0364||95.0|-1.09|-0.04||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3||-0.04|-1.09|0.0364
71721376|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.914||95.0|-0.51|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4||0.46|-0.51|0.9140
71721377|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.27||0.7789||95.0|-0.62|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5||0.47|-0.62|0.7789
71721378|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.3189||95.0|-0.95|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6||0.32|-0.95|0.3189
71769227|NCT01437995|143038766|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.40
71721379|NCT00368745|142959507|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.0031||95.0|-1.26|-0.27||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint \[LOCF\]||-0.27|-1.26|0.0031
71769228|NCT01437995|143038766|SUPERIORITY_OR_OTHER|||||||0.032|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.032
71721380|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.126||95.0|-0.86|0.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||0.11|-0.86|0.1260
71721381|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.29||0.0074||95.0|-1.4|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.40|0.0074
71721382|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.38||0.125||95.0|-1.35|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.17|-1.35|0.1250
71721383|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.6||0.8991||95.0|-1.17|1.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.32|-1.17|0.8991
71721384|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.53||0.1747||95.0|-2.07|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.46|-2.07|0.1747
71721385|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.45||0.0744||95.0|-1.79|0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.09|-1.79|0.0744
71721386|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.35||0.0063||95.0|-1.67|-0.29||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||-0.29|-1.67|0.0063
71769229|NCT01437995|143038766|SUPERIORITY_OR_OTHER|||||||0.21|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC||||0.21
71769230|NCT01437995|143038767|SUPERIORITY_OR_OTHER|||||||0.14|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.14
71769231|NCT01437995|143038767|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||<0.001
71721387|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.34||0.014||95.0|-1.56|-0.18||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||-0.18|-1.56|0.0140
71721388|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0267||95.0|-1.46|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||-0.09|-1.46|0.0267
71721389|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.38||0.5104||95.0|-1.03|0.52||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.52|-1.03|0.5104
71721390|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.43||0.2702||95.0|-1.35|0.39||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.39|-1.35|0.2702
71721391|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.42||0.1241||95.0|-1.52|0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||0.19|-1.52|0.1241
71721392|NCT00368745|142959508|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.36||0.0109||95.0|-1.67|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.22|-1.67|0.0109
71721393|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.28||0.0226||95.0|-1.22|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1||-0.09|-1.22|0.0226
71721394|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34||0.0099||95.0|-1.58|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2||-0.22|-1.58|0.0099
71721395|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.35||0.2827||95.0|-1.07|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3||0.32|-1.07|0.2827
71721396|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.58||0.8232||95.0|-1.07|1.34||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4||1.34|-1.07|0.8232
71721397|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.66||0.2409||95.0|-2.41|0.72||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5||0.72|-2.41|0.2409
71721398|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.61||0.476||95.0|-1.73|0.84||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6||0.84|-1.73|0.4760
71769232|NCT01437995|143038767|SUPERIORITY_OR_OTHER|||||||0.031|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio||||0.031
71721399|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.1252||95.0|-1.14|0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1||0.14|-1.14|0.1252
71721400|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0717||95.0|-1.26|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2||0.06|-1.26|0.0717
71721401|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.35||0.0707||95.0|-1.33|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3||0.06|-1.33|0.0707
71721402|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.4341||95.0|-1.08|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4||0.47|-1.08|0.4341
71721403|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.42||0.37||95.0|-1.23|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5||0.47|-1.23|0.3700
71721404|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.43||0.0328||95.0|-1.83|-0.08||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6||-0.08|-1.83|0.0328
71721405|NCT00368745|142959509|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.39||0.0096||95.0|-1.8|-0.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint \[LOCF\]||-0.26|-1.80|0.0096
71721406|NCT00368745|142959510|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|2.68||0.8897||95.0|-5.74|4.99||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as the covariate||||4.99|-5.74|0.8897
71769233|NCT04456673|143038773|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Risk Difference (RD)|-0.435||||0.0002|TWO_SIDED|95.0|-0.682|-0.188|||Negative binomial model||Derived using delta method|Derived using negative binomial model with the total number of the events occurring during the 52-week treatment period as the response variable, and treatment group, region (pooled country), ICS dose, smoking status at screening, baseline disease severity, and number of moderate or severe COPD exacerbation events within one year prior to the study as covariates, and log-transformed treatment duration as an offset variable.||-0.188|-0.682|0.0002
71769234|NCT04456673|143038774|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least Square (LS) Mean Difference|0.082||||0.0001|TWO_SIDED|95.0|0.04|0.124|||MMRM model|||Derived from mixed-effect model with repeated measures (MMRM) model with the change from baseline in pre-bronchodilator FEV1 up to Week 12 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.124|0.040|0.0001
71769235|NCT04456673|143038775|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|-3.371||||0.0068|TWO_SIDED|95.0|-5.811|-0.931|||MMRM model|||Derived from MMRM model with the change from baseline in SGRQ total score up to Week 52 as response variables, and treatment group, region (pooled country), ICS dose, smoking status at screening, treatment-by-visit interaction, baseline SGRQ total score, and SGRQ baseline-by-visit interaction as covariates.||-0.931|-5.811|0.0068
71769236|NCT04456673|143038776|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Odds Ratio (OR)|1.164||||0.3329|TWO_SIDED|95.0|0.856|1.581|||Regression, Logistic|||Derived from logistic regression model which includes treatment group, region (pooled country), ICS dose, smoking status at screening, and baseline SGRQ total score as covariates.||1.581|0.856|0.3329
71769237|NCT04456673|143038777|SUPERIORITY|A hierarchical testing procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|LS Mean Difference|0.062||||0.0182|TWO_SIDED|95.0|0.011|0.113|||MMRM model|||Derived from MMRM model with the change from baseline in pre-bronchodilator FEV1 up to Week 52 as response variables, and treatment group, age, sex, height, region (pooled country), ICS dose, smoking status at screening, visit, treatment-by-visit interaction, baseline pre-bronchodilator FEV1, and FEV1 baseline-by-visit interaction as covariates.||0.113|0.011|0.0182
71769238|NCT00246571|143038795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.8885|TWO_SIDED|95.0|0.8889|1.628||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).|Log Rank|||For core radiology laboratory assessment||1.6280|0.8889|0.8885
71769239|NCT00246571|143038795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1598||||0.8472|TWO_SIDED|95.0|0.8703|1.5457||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.|Log Rank|||For investigator's assessment||1.5457|0.8703|0.8472
71769240|NCT00246571|143038796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.9624|TWO_SIDED|95.0|0.06|1.71||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Core radiology laboratory assessment||1.71|0.06|0.9624
71769241|NCT00246571|143038796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.814|TWO_SIDED|95.0|0.27|1.98||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Investigator's assessment||1.98|0.27|0.8140
71769242|NCT00246571|143038799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1599||||0.8394|TWO_SIDED|95.0|0.8648|1.5558||One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Log Rank||Hazard ratio for sunitinib versus standard of care.|||1.5558|0.8648|0.8394
71769243|NCT04896229|143038830|SUPERIORITY||Slope|1.2|STANDARD_ERROR_OF_MEAN|0.52||0.022|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.022
71887529|NCT01058096|143295888|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.3||||0.0004|TWO_SIDED|95.0|-6.7|-1.9|||Mixed Models Analysis||cariprazine - placebo|||-1.9|-6.7|0.0004
71769244|NCT04896229|143038831|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.800
71769245|NCT04896229|143038832|SUPERIORITY||Slope|0.58|STANDARD_ERROR_OF_MEAN|0.49||0.235|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.235
71769246|NCT04896229|143038833|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.3||0.325|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.325
71769247|NCT04896229|143038834|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.502|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.502
71769248|NCT04896229|143038835|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.005|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.005
71769249|NCT04896229|143038836|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.712|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.712
71769250|NCT04896229|143038837|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.245|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.245
71887530|NCT01058096|143295889|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4||||0.0027|TWO_SIDED|95.0|-0.7|-0.1|||MMRM analysis||cariprazine - placebo|||-0.1|-0.7|0.0027
71721407|NCT00368745|142959511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0626||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0626
71887531|NCT00408694|143295900|OTHER|||||||||||||||||Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.|If 3 of the first 14 patients or 4 of the first 42 patients experience the specified adverse events, then the regimen is considered unacceptable as calculated by the Fleming method for a two-stage design with type I error and the statistical power were set at 0.14 and 0.83, respectively.|||
71887532|NCT00820755|143295933|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.959||||0.1265|TWO_SIDED|95.0|0.736|1.25|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (interactive voice response system \[IVRS\]) and tumor response status at the end of combination therapy ('complete response \[CR\] or partial response \[PR\]' versus 'other').||1.250|0.736|0.1265
71887533|NCT00820755|143295935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.0622||95.0|0.613|0.976|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (IVRS) and tumor response status at the end of combination therapy ('CR or PR' versus 'other').||0.976|0.613|0.0622
71887534|NCT02063035|143295941|SUPERIORITY|||||||0.1318|||||||Wilcoxon (Mann-Whitney)|||||||0.1318
71721408|NCT00368745|142959512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank|||||||0.0148
71721409|NCT00368745|142959513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1159||95.0||||p-value is obtained using Cochran-Mantel-Haenszel option|Cochran-Mantel-Haenszel|||||||0.1159
71721410|NCT00282087|142959546|SUPERIORITY_OR_OTHER||Two year PFS|78.0||||0.15|TWO_SIDED|95.0|67.0|91.0|||Bayesian Posterior Probability|||The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.||91|67|0.15
71721411|NCT00282087|142959548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00269|||||TWO_SIDED||||||Cox Proportional Hazards|||Age correlation with progression-free survival for patients on study treatment.||||
71721412|NCT00282087|142959549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02|||||TWO_SIDED||||||Cox Proportional Hazards|||Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.||||
71721413|NCT00282087|142959550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.101|||||TWO_SIDED||||||Cox Proportional Hazards|||Uterine serosal involvement correlation with progression-free survival for patients on study treatment.||||
71887535|NCT00091832|143295964|SUPERIORITY_OR_OTHER|||||||0.245|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.245
71721414|NCT00282087|142959551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.00676|||||TWO_SIDED||||||Cox Proportional Hazards|||Mitotic rate correlation with progression-free survival for patients on study treatment.||||
71721415|NCT00282087|142959552|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.708|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.||||
71721416|NCT00282087|142959553|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.906|||||TWO_SIDED||||||Cox Proportional Hazards|||Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.||||
71721417|NCT00282087|142959554|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.207|||||TWO_SIDED||||||Cox Proportional Hazards|||1988 FIGO Stage correlation with progression-free survival for patients on study treatment.||||
71721418|NCT00282087|142959555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|-0.564|||||TWO_SIDED||||||Cox Proportional Hazards|||Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.||||
71721419|NCT03938103|142959572|OTHER|||||||0.101|||||||Mixed Models Analysis|||||||0.101
71721420|NCT03938103|142959573|OTHER|||||||0.383|||||||Mixed Models Analysis|||||||0.383
71721421|NCT03248531|142959593|OTHER||Mean posterior difference|31.2|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|11.0|50.4|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 95% credible intervals were presented for the bimekizumab (BKZ) vs placebo (PBO) comparison.||50.4|11.0|
71721422|NCT03248531|142959593|OTHER||Mean posterior difference|-2.2|STANDARD_DEVIATION|10.6|||TWO_SIDED|60.0|-11.2|6.6|||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model. 60% credible intervals were presented for the BKZ vs adalimumab (ADA) comparison.||6.6|-11.2|
71721423|NCT03248531|142959593|OTHER||Pr [Diff>0%] (%)|99.8|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
71721424|NCT03248531|142959593|OTHER||Pr[Diff > 0%](%)|42.1|||||||||||Regression, Logistic|||Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Treatment and Baseline Hurley Stage were included as predictors in the model.||||
71769251|NCT04896229|143038838|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.282|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.282
71887536|NCT00091832|143295965|SUPERIORITY_OR_OTHER|||||||0.848|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||||||0.848
71887537|NCT00091832|143295966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||||95.0|0.68|4.35|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.35|0.68|
71887538|NCT00091832|143295966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||||95.0|0.51|3.24|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.24|0.51|
71887539|NCT00091832|143295966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.34|2.29|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.29|0.34|
71887540|NCT00091832|143295966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||||95.0|0.51|3.2|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.20|0.51|
71721425|NCT04075513|142959635|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was \> 0.|Least square mean difference|3.16|STANDARD_ERROR_OF_MEAN|1.163||0.0067|TWO_SIDED|95.0|0.88|5.44||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 90% of Tresiba LS mean.|Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||5.44|0.88|0.0067
71721426|NCT04075513|142959636|NON_INFERIORITY|Non-inferiority was based on a relative margin of 10%. Since lower CV means better outcome, non-inferiority was demonstrated if the upper bound of the two-sided 95% CI of the difference between Toujeo LS mean and 110% of Tresiba LS mean at Week 12 was \< 0.|Least square mean difference|-5.44|STANDARD_ERROR_OF_MEAN|0.542|<|0.0001|TWO_SIDED|95.0|-6.5|-4.38||Threshold of significance at \<0.05.|ANCOVA||This estimation parameter corresponds to the difference between Toujeo LS mean and 110% of Tresiba LS mean.|A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||-4.38|-6.50|<0.0001
71721427|NCT04075513|142959637|SUPERIORITY|Superiority was demonstrated if the lower bound of the two-sided 95% CI of the adjusted difference estimate of Toujeo and Tresiba at Week 12 was \>0.|Least square mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.225||0.0548|TWO_SIDED|95.0|-4.75|0.05||Threshold of significance at \<0.05.|ANCOVA|||A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.||0.05|-4.75|0.0548
71721428|NCT00904670|142959675|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-12.46|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-14.75|-10.17|||ANOVA|||Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-10.17|-14.75|<0.0001
71721429|NCT00904670|142959676|SUPERIORITY_OR_OTHER||LS mean difference|-6.32|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-8.53|-4.11|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-4.11|-8.53|<0.0001
71721430|NCT00904670|142959676|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|95.0|-12.04|-7.91|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-7.91|-12.04|<0.0001
71721431|NCT00904670|142959676|SUPERIORITY_OR_OTHER||LS mean difference|-9.33|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|95.0|-11.92|-6.75|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-6.75|-11.92|<0.0001
71721432|NCT00904670|142959676|SUPERIORITY_OR_OTHER||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.11||0.0016|TWO_SIDED|95.0|-6.04|-1.54|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.54|-6.04|0.0016
71721433|NCT00904670|142959676|SUPERIORITY_OR_OTHER||LS mean difference|-4.77|STANDARD_ERROR_OF_MEAN|1.4||0.0016|TWO_SIDED|95.0|-7.61|-1.94|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.94|-7.61|0.0016
71721434|NCT00904670|142959677|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.38||0.0051|TWO_SIDED|95.0|-1.88|-0.36|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.36|-1.88|0.0051
71887541|NCT00091832|143295966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||||95.0|0.7|4.34|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.34|0.70|
71887542|NCT00091832|143295967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||||95.0|0.69|4.79|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||4.79|0.69|
71887543|NCT00091832|143295967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||||95.0|0.25|1.76|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.76|0.25|
71721435|NCT00904670|142959677|SUPERIORITY_OR_OTHER||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.23|-0.95|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.95|-2.23|<0.0001
71721436|NCT00904670|142959677|SUPERIORITY_OR_OTHER||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.54||0.0001|TWO_SIDED|95.0|-3.37|-1.2|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.20|-3.37|0.0001
71721437|NCT00904670|142959677|SUPERIORITY_OR_OTHER||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.51||0.0055|TWO_SIDED|95.0|-2.52|-0.47|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.47|-2.52|0.0055
71721438|NCT00904670|142959677|SUPERIORITY_OR_OTHER||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.1977|TWO_SIDED|95.0|-1.38|0.29|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.29|-1.38|0.1977
71721439|NCT00904670|142959677|SUPERIORITY_OR_OTHER||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.43||0.0491|TWO_SIDED|95.0|-1.76|0.0|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.00|-1.76|0.0491
71721440|NCT00904670|142959678|SUPERIORITY_OR_OTHER||LS mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.36|-1.02|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.02|-2.36|<0.0001
71721441|NCT00904670|142959678|SUPERIORITY_OR_OTHER||LS mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.5|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.50|<0.0001
71721442|NCT00904670|142959678|SUPERIORITY_OR_OTHER||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.77|-2.13|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.13|-3.77|<0.0001
71721443|NCT00904670|142959678|SUPERIORITY_OR_OTHER||LS mean difference|-2.49|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.33|-1.66|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.66|-3.33|<0.0001
71721444|NCT00904670|142959678|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.4||0.0035|TWO_SIDED|95.0|-2.07|-0.44|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.44|-2.07|0.0035
71721445|NCT00904670|142959678|SUPERIORITY_OR_OTHER||LS mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.53||0.0109|TWO_SIDED|95.0|-2.51|-0.35|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.35|-2.51|0.0109
71721446|NCT00904670|142959679|SUPERIORITY_OR_OTHER||LS mean difference|25.61|STANDARD_ERROR_OF_MEAN|4.61|<|0.0001|TWO_SIDED|95.0|16.26|34.96|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||34.96|16.26|<0.0001
71721447|NCT00904670|142959679|SUPERIORITY_OR_OTHER||LS mean difference|37.1|STANDARD_ERROR_OF_MEAN|5.21|<|0.0001|TWO_SIDED|95.0|26.54|47.66|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||47.66|26.54|<0.0001
71829751|NCT05328297|143163730|SUPERIORITY||Least Square Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.96|=|0.438|TWO_SIDED|80.0|-2.84|2.23|||Mixed Model for Repeated Measures (MMRM)|||||2.23|-2.84|=0.438
71887544|NCT00091832|143295967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||||95.0|0.24|1.77|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.77|0.24|
71721448|NCT00904670|142959679|SUPERIORITY_OR_OTHER||LS mean difference|45.77|STANDARD_ERROR_OF_MEAN|7.35|<|0.0001|TWO_SIDED|95.0|30.89|60.65|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||60.65|30.89|<0.0001
71721449|NCT00904670|142959679|SUPERIORITY_OR_OTHER||LS mean difference|35.46|STANDARD_ERROR_OF_MEAN|6.57|<|0.0001|TWO_SIDED|95.0|22.14|48.78|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||48.78|22.14|<0.0001
71721450|NCT00904670|142959679|SUPERIORITY_OR_OTHER||LS mean difference|14.86|STANDARD_ERROR_OF_MEAN|5.86||0.0155|TWO_SIDED|95.0|3.0|26.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||26.73|3.00|0.0155
71721451|NCT00904670|142959679|SUPERIORITY_OR_OTHER||LS mean difference|20.69|STANDARD_ERROR_OF_MEAN|6.18||0.0019|TWO_SIDED|95.0|8.17|33.22|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||33.22|8.17|0.0019
71721452|NCT00904670|142959681|SUPERIORITY_OR_OTHER||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.52||0.0014|TWO_SIDED|95.0|-2.85|-0.74|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.74|-2.85|0.0014
71721453|NCT00904670|142959681|SUPERIORITY_OR_OTHER||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-3.76|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.82|-3.76|<0.0001
71721454|NCT00904670|142959681|SUPERIORITY_OR_OTHER||LS mean difference|-3.89|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.12|-2.67|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.67|-5.12|<0.0001
71721455|NCT00904670|142959681|SUPERIORITY_OR_OTHER||LS mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.65||0.0002|TWO_SIDED|95.0|-3.97|-1.33|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.33|-3.97|0.0002
71721456|NCT00904670|142959681|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.45||0.3492|TWO_SIDED|95.0|-1.34|0.49|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||0.49|-1.34|0.3492
71721457|NCT00904670|142959681|SUPERIORITY_OR_OTHER||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.5||0.0105|TWO_SIDED|95.0|-2.34|-0.33|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.33|-2.34|0.0105
71721458|NCT00904670|142959682|SUPERIORITY_OR_OTHER||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.0|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.00|-2.43|<0.0001
71721459|NCT00904670|142959682|SUPERIORITY_OR_OTHER||LS mean difference|-2.94|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.78|-2.1|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.10|-3.78|<0.0001
71721460|NCT00904670|142959682|SUPERIORITY_OR_OTHER||LS mean difference|-3.34|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.11|-2.57|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-2.57|-4.11|<0.0001
71887545|NCT00091832|143295967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||||95.0|0.22|1.58|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.58|0.22|
71721461|NCT00904670|142959682|SUPERIORITY_OR_OTHER||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.64|-1.76|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-1.76|-3.64|<0.0001
71721462|NCT00904670|142959682|SUPERIORITY_OR_OTHER||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.41||0.0006|TWO_SIDED|95.0|-2.4|-0.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.73|-2.40|0.0006
71721463|NCT00904670|142959682|SUPERIORITY_OR_OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.4||0.0087|TWO_SIDED|95.0|-1.94|-0.3|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.||-0.30|-1.94|0.0087
71721464|NCT00286091|142959683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0284|TWO_SIDED|95.0|0.73|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|Primary and secondary endpoint analyses were conducted hierarchically. To preserve an overall type I error rate of 0.05, a 0.0488 2-sided test of bone metastasis-free survival was performed. If superiority of denosumab over placebo was established, time to first bone metastasis was tested with a 2-sided significance level of 0.050. If superiority of denosumab over placebo was also established, overall survival time was tested at a 2-sided significance level of 0.050.||0.98|0.73|0.0284
71721465|NCT00286091|142959684|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0317|TWO_SIDED|95.0|0.71|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||0.98|0.71|0.0317
71721466|NCT00286091|142959685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9125|TWO_SIDED|95.0|0.85|1.2|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio \< 1 favors denosumab.|||1.20|0.85|0.9125
71721467|NCT03423238|142959689|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||Baseline||||0.388
71721468|NCT03423238|142959690|SUPERIORITY|||||||0.017|||||||ANCOVA|||Month 3||||0.017
71769252|NCT04896229|143038839|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.289|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.289
71721469|NCT03423238|142959690|SUPERIORITY|||||||0.002|||||||ANCOVA|||Month 6||||0.002
71721470|NCT03423238|142959691|SUPERIORITY|||||||0.653|||||||t-test, 2 sided|||Baseline||||0.653
71721471|NCT03423238|142959692|SUPERIORITY|||||||0.684|||||||ANCOVA|||Month 3||||0.684
71721472|NCT03423238|142959692|SUPERIORITY|||||||0.458|||||||ANCOVA|||Month 6||||0.458
71721473|NCT03423238|142959693|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Baseline||||0.550
71721474|NCT03423238|142959694|SUPERIORITY|||||||0.973|||||||ANCOVA|||Month 3||||0.973
71721475|NCT03423238|142959694|SUPERIORITY|||||||0.432|||||||ANCOVA|||Month 6||||0.432
71769253|NCT04896229|143038840|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.296|TWO_SIDED||||||t-test, 2 sided|||The results show the condition x time interaction from the growth model, and the parameter estimate describes the relative change of the intervention condition to the treatment-as-usual condition, for a unit change in time.||||.296
71721476|NCT03423238|142959695|SUPERIORITY|||||||0.23063|||||||t-test, 2 sided|||Baseline||||0.23063
71887546|NCT00091832|143295967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||||95.0|0.25|1.92|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||1.92|0.25|
71721477|NCT03423238|142959696|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
71721478|NCT03423238|142959696|SUPERIORITY|||||||0.874|||||||ANCOVA|||Month 6||||0.874
71721479|NCT03423238|142959697|SUPERIORITY|||||||0.563|||||||t-test, 2 sided|||Baseline||||0.563
71721480|NCT03423238|142959698|SUPERIORITY|||||||0.008|||||||ANCOVA|||Month 3||||0.008
71721481|NCT03423238|142959698|SUPERIORITY|||||||0.922|||||||ANCOVA|||Month 6||||0.922
71721482|NCT03423238|142959699|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||Baseline||||0.667
71721483|NCT03423238|142959700|SUPERIORITY|||||||0.692|||||||ANCOVA|||Month 3||||0.692
71721484|NCT03423238|142959700|SUPERIORITY|||||||0.59|||||||ANCOVA|||Month 6||||0.590
71721485|NCT03423238|142959701|SUPERIORITY|||||||0.844|||||||t-test, 2 sided|||Baseline||||0.844
71721486|NCT03423238|142959702|SUPERIORITY|||||||0.721|||||||ANCOVA|||Month 3||||0.721
71721487|NCT03423238|142959702|SUPERIORITY|||||||0.851|||||||ANCOVA|||Month 6||||0.851
71721488|NCT03423238|142959703|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||Baseline||||0.815
71721489|NCT03423238|142959704|SUPERIORITY|||||||0.488|||||||ANCOVA|||Month 3||||0.488
71721490|NCT03423238|142959704|SUPERIORITY|||||||0.237|||||||ANCOVA|||Month 6||||0.237
71721491|NCT03423238|142959705|SUPERIORITY|||||||0.506|||||||t-test, 2 sided|||||||0.506
71721492|NCT03423238|142959706|SUPERIORITY|||||||0.549|||||||ANCOVA|||Month 3||||0.549
71721493|NCT03423238|142959706|SUPERIORITY|||||||0.303|||||||ANCOVA|||Month 6||||0.303
71721494|NCT03423238|142959707|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||Baseline||||0.934
71721495|NCT03423238|142959708|SUPERIORITY|||||||0.792|||||||ANCOVA|||Month 3||||0.792
71721496|NCT03423238|142959708|SUPERIORITY|||||||0.417|||||||ANCOVA|||Month 6||||0.417
71721497|NCT03423238|142959709|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Baseline||||0.685
71721498|NCT03423238|142959710|SUPERIORITY|||||||0.854|||||||ANCOVA|||Month 3||||0.854
71721499|NCT03423238|142959710|SUPERIORITY|||||||0.903|||||||ANCOVA|||Month 6||||0.903
71721500|NCT03423238|142959711|SUPERIORITY|||||||0.569|||||||t-test, 2 sided|||Baseline||||0.569
71721501|NCT03423238|142959712|SUPERIORITY|||||||0.824|||||||ANCOVA|||Month 3||||0.824
71721502|NCT03423238|142959712|SUPERIORITY|||||||0.401|||||||ANCOVA|||Month 6||||0.401
71721503|NCT03423238|142959713|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Baseline||||0.188
71721504|NCT03423238|142959714|SUPERIORITY|||||||0.338|||||||ANCOVA|||Month 3||||0.338
71721505|NCT03423238|142959714|SUPERIORITY|||||||0.484|||||||ANCOVA|||Month 6||||0.484
71721506|NCT03423238|142959715|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||Baseline||||0.533
71721507|NCT03423238|142959716|SUPERIORITY|||||||0.992|||||||ANCOVA|||Month 3||||0.992
71721508|NCT03423238|142959716|SUPERIORITY|||||||0.639|||||||ANCOVA|||Month 6||||0.639
71721509|NCT00923351|142959732|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Fisher Exact|||||||0.043
71721510|NCT05285644|142959771|OTHER|Difference (2-sided)|Difference in Percentages|34.4|||<|0.0001|TWO_SIDED|95.0|26.9|42.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|42.0|26.9|<0.0001
71721511|NCT05285644|142959772|OTHER|Difference (2-sided)|Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.06||0.0138|TWO_SIDED|95.0|-9.1|-1.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||-1.0|-9.1|0.0138
71721512|NCT05285644|142959773|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|5.8|8.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|8.6|5.8|<0.0001
71721513|NCT05285644|142959774|OTHER|Difference (2-sided)|Difference in Percentages|26.7|||<|0.0001|TWO_SIDED|95.0|19.5|34.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|34.0|19.5|<0.0001
71887547|NCT00091832|143295968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.51|1.31|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.31|0.51|
71721514|NCT05285644|142959775|OTHER|Difference (2-sided)|Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|4.9|7.5||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||7.5|4.9|<0.0001
71721515|NCT05285644|142959776|OTHER|Difference (2 sided)|Difference in Percentages|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|41.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|41.4|24.8|<0.0001
71721516|NCT05285644|142959777|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.5|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|6.0|9.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.0|6.0|<0.0001
71721517|NCT05285644|142959778|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.28||0.2184|TWO_SIDED|95.0|-7.3|1.7||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.7|-7.3|0.2184
71721518|NCT05285644|142959779|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.43||0.266|TWO_SIDED|94.0|-7.5|2.1||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.1|-7.5|0.2660
71721519|NCT05285644|142959780|OTHER|Difference (2-sided)|Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|2.37||0.2741|TWO_SIDED|95.0|-7.2|2.0||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||2.0|-7.2|0.2741
71721520|NCT05285644|142959781|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.43||0.159|TWO_SIDED|95.0|-8.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-8.2|0.1590
71721521|NCT05285644|142959782|OTHER|Difference (2-sided)|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.67||0.1369|TWO_SIDED|95.0|-9.2|1.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||1.3|-9.2|0.1369
71721522|NCT01696981|142959809|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
71721523|NCT01696981|142959811|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.85|||Poisson regression|||||0.85|0.72|
71721524|NCT01696981|142959813|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.87|||Poisson regression|||||0.87|0.63|
71721525|NCT03335150|142959832|OTHER|Equality|Mean Difference (Final Values)|0.4856||||0.6662|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = Standard Error (SE) of the interaction term.|||||0.6662
71721526|NCT03335150|142959832|OTHER|Equality|Mean Difference (Final Values)|0.2415||||0.1617|TWO_SIDED||||||Mixed Models Analysis|Mean Matrix Reasoning Total (MRT) difference between two visits while controlling for intervention.|estimated value = SE|||||0.1617
71721527|NCT03335150|142959832|OTHER|Equality|Mean Difference (Final Values)|0.5087||||0.6236|TWO_SIDED||||||Mixed Models Analysis|Mean MRT difference between two interventions while controlling for visit.|estimated value = SE|||||0.6236
71721528|NCT03335150|142959833|OTHER|Equality|Mean Difference (Final Values)|0.58||||0.0496|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated value = SE of interaction term|||||0.0496
71721529|NCT03335150|142959834|OTHER|Equality|Mean Difference (Final Values)|1.62||||0.047|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.047
71887548|NCT00091832|143295968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.64|1.65|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.65|0.64|
71721530|NCT03335150|142959835|OTHER|Equality|Mean Difference (Final Values)|2.97||||0.001|TWO_SIDED|||||Interaction Term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.001
71721531|NCT03335150|142959836|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.02|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.020
71721532|NCT03335150|142959837|OTHER|Equality|Mean Difference (Final Values)|1.26||||0.444|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of interaction term|||||0.444
71721533|NCT03335150|142959837|OTHER|Equality|Mean Difference (Final Values)|1.145||||0.0233|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between intervention groups controlling for visit and other significant covariates.|estimated value = SE|||||0.0233
71721534|NCT03335150|142959837|OTHER|Equality|Mean Difference (Final Values)|0.6281|||<|0|TWO_SIDED||||||Mixed Models Analysis|There is significant difference in MIST between baseline and week 10 controlling for intervention group and other significant covariates|estimated value = SE|||||<0.000
71721535|NCT03335150|142959838|OTHER|Equality|Mean Difference (Final Values)|2.205||||0.073|TWO_SIDED|||||Interaction term|Mixed Models Analysis||estimated value = SE of interaction term|||||0.073
71721536|NCT03335150|142959839|OTHER|Equality|Mean Difference (Final Values)|2.25||||0.82|TWO_SIDED|||||Interaction Term|Mixed Models Analysis|||||||0.82
71721537|NCT03335150|142959839|OTHER|Equality|Mean Difference (Final Values)|1.1172||||0.0257|TWO_SIDED||||||Mixed Models Analysis|Mean PDQ-39 difference between baseline and week 10 controlling for intervention and covariates.|estimated value = SE|||||0.0257
71769254|NCT00159822|143038867|SUPERIORITY_OR_OTHER||Percent of subjects with success|31.7||||||95.0|18.08|48.09|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|For sample size calculation, null hypothesis (p\<p0) is defined as response rate \<15% (ie, weak drug efficacy). Alternative hypothesis (p\>pA) defined as response rate \>30%. To reduce the chance of incorrectly rejecting the null hypothesis to 5% (α=5%) and incorrectly rejecting the alternate hypothesis to 20% (β=20%) it was calculated that a sample size of 48 subjects was required. Null hypothesis was rejected (assessing efficacy of study drug) if the number of eligible success was ≥ than n=12.||48.09|18.08|
71769255|NCT00159822|143038868|SUPERIORITY_OR_OTHER||Percent of subjects with success|33.3||||||95.0|18.6|51.0|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|Month 3 success=yes||51.0|18.6|
71721538|NCT03335150|142959839|OTHER|Equality|Mean Difference (Final Values)|3.8649||||0.1101|TWO_SIDED||||||Mixed Models Analysis|Difference in PDQ-39 between two interventions controlling for visit and covariates.|estimated value = SE|||||0.1101
71721539|NCT03335150|142959840|OTHER|Equality|Median Difference (Final Values)|1.784||||0.0263|TWO_SIDED|||||Interaction term|Mixed Models Analysis||Estimated Value = SE of the interaction term.|||||0.0263
71769256|NCT00159822|143038868|SUPERIORITY_OR_OTHER||Percent of subjects with success|43.9||||||95.0|28.5|60.3|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|EOT success=yes||60.3|28.5|
71721540|NCT02907216|142959861|NON_INFERIORITY|Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.||2.74|-2.66|
71721541|NCT02907216|142959861|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-T antibodies should be ≥ -10%.|Difference-Seroprotective concentration|-0.69|||||TWO_SIDED|95.0|-4.39|2.71|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-T antibody concentration ≥ 0.1 IU/mL.||2.71|-4.39|
71769257|NCT00159822|143038874|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate overall survival|0.85||||||95.0|0.725|0.976|||||Global survival rate calculated using Kaplan-Meier estimate of overall survival.|||0.976|0.725|
71769258|NCT00713310|143038879|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|-1.1||||0.924|TWO_SIDED|95.0|-22.7|20.5|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||20.5|-22.7|0.9240
71721542|NCT02907216|142959862|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-PT antibodies should be ≥ -10%.|Difference-Seroprotective concentration|2.99|||||TWO_SIDED|95.0|-2.7|9.12|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-PT antibody concentration ≥ 10 IU/mL.||9.12|-2.7|
71721543|NCT02907216|142959862|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-FHA antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||TWO_SIDED|95.0|-2.66|2.72|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-FHA antibody concentration ≥ 10 IU/mL.||2.72|-2.66|
71721544|NCT02907216|142959863|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 1 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.68|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 1 seroprotective titres ≥ 8 ED50.||2.74|-2.68|
71721545|NCT02907216|142959863|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 2 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||TWO_SIDED|95.0|-2.92|2.95|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 2 seroprotective titres ≥ 8 ED50.||2.95|-2.92|
71721546|NCT02907216|142959863|NON_INFERIORITY|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 3 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.81|||||TWO_SIDED|95.0|-2.04|4.47|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 3 seroprotective titres ≥ 8 ED50.||4.47|-2.04|
71721547|NCT01433042|142959944|SUPERIORITY_OR_OTHER||percentage|98.0||||||||||since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|percentage|percentage of SB3 images graded as superior in image quality to SB2|since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|"Primary Endpoint~o Physician's subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2."||||
71721548|NCT00281099|142959951|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates.|Hazard Ratio (HR)|1.139||||||96.3|1.139|1.59||There were 167 events by 90 subjects in the VVI 40 arm, compared to 188 events among 104 subjects in the MVP arm.|Andersen-Gill Model|An Andersen-Gill model was used to account for multiple primary endpoints per subject.|4 interim analyses were performed \& the O'Brien-Fleming alpha-spending function required a 96.3% confidence interval.|"This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40."||1.590|1.139|
71721549|NCT00281099|142959952|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.241. The one-sided upper confidence bound for the hazard ratio had to be less than 1.241 for the null hypothesis to be rejected. The threshold of 1.241 was derived by using a non-inferiority threshold of a 5 percentage point difference in 24 month HF event-free rates.|Hazard Ratio (HR)|1.029||||||95.0|1.029|1.381|||Andersen-Gill Model|An Andersen-Gill model was utilized to account for multiple HF events per subject.||This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.||1.381|1.029|
71721550|NCT00281099|142959953|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interactions between randomization arm and time.|Cumulative Logits Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.||||> 0.05
71721551|NCT00281099|142959953|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interaction terms between randomization arm and time.|Cumulative Logit Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.||||> 0.05
71769259|NCT00713310|143038880|SUPERIORITY_OR_OTHER||High-Low Dose Difference Success Rates|1.4||||0.8193|TWO_SIDED|95.0|-20.2|23.0|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.||23.0|-20.2|0.8193
71887549|NCT00091832|143295968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
71721552|NCT00281099|142959954|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Model fit with time and arm as covariates, the interaction between them included. Interaction shown to not be significant and model refit without it.||A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71721553|NCT00281099|142959955|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71721554|NCT00281099|142959956|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|The model was fit with time and arm as covariates.||"A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.0424
71721555|NCT00281099|142959956|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Models were fit with time and arm as covariates.||"Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume."||||>0.10
71721556|NCT00281099|142959957|SUPERIORITY_OR_OTHER|||||||0.0418||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|The model fit with time and arm as covariates.||A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.0418
71721557|NCT00281099|142959958|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71721558|NCT00281099|142959959|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Model fit with time and arm as covariates.||A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||0.9490
71721559|NCT00281099|142959960|SUPERIORITY_OR_OTHER||||||>|0.1||95.0||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models fit with time and arm as covariates.||A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.||||> 0.10
71769260|NCT00329901|143038889|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|9.0|||||TWO_SIDED|95.0|5.0|14.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline||14|5|
71769261|NCT00329901|143038889|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus(Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo||2|-1|
71769262|NCT00329901|143038889|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0||||||Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||1|-12|
71769263|NCT00329901|143038889|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-3.0|||||TWO_SIDED|95.0|-9.0|3.0||||||Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||3|-9|
71721560|NCT00281099|142959961|SUPERIORITY_OR_OTHER|||||||0.8403||95.0||||The a priori threshold for significance for Arm was 0.05.|Cumulative Logits Model|Because Composite Mitral Regurgitation Score was measured on the ordinal scale, a GEE cumulative logits model was fit.||"A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."||||0.8403
71721561|NCT00281099|142959962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.949||||||95.0|0.949|1.209|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which true VT/VF occurred) within subject.|Because of the possible correlation within subject of days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.209|0.949|
71721562|NCT00281099|142959962|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|-0.015||||||95.0|-0.015|0.033|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.033|-0.015|
71721563|NCT00281099|142959962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||||95.0|1.31|1.858|||Andersen-Gill model|This model was fit to account for multiple events (i.e. days in which non-VT/VF detected by device as VT/VF) within subject.|Because of the possible correlation within a subject for days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.||1.858|1.310|
71721564|NCT00281099|142959962|SUPERIORITY_OR_OTHER||Difference in Annualized Rates|0.017||||||95.0|0.017|0.036|||Bootstrap Confidence Interval|||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.||0.036|0.017|
71721565|NCT00281099|142959963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.7166||95.0|1.22|3.0||The threshold for significance was the one-sided upper confidence bound being less than 1.|Andersen-Gill model|||This analysis compared the hazard rates for clinically important AF (defined as a calendar day with \>20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.||3.0|1.22|0.7166
71721566|NCT00281099|142959963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-100.0|0.8||The threshold for significance was defined as the upper one-sided confidence bound being less than 0.|Bootstrap Confidence Interval|||This analysis compared the percentage of days with \>20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.||0.8|-100|
71721567|NCT00281099|142959963|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||The a priori threshold for statistical significance was 0.05.|Log Rank|A one-sided test was used.||This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or \< 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.||||0.325
71721568|NCT00281099|142959963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.145||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF through 6 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.145|0|
71721569|NCT00281099|142959963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.227||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 6 to 12 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.227|0|
71721570|NCT00281099|142959963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.261||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 12 to 24 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.261|0|
71769264|NCT00329901|143038889|NON_INFERIORITY_OR_EQUIVALENCE|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference \[(Tdap + MenACWY-CRM) minus (Tdap + saline)\] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0||||||Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo||-2|-13|
71721571|NCT00281099|142959963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||||95.0|-0.1|0.11||The a priori threshold for significance was defined as the one-sided upper 95% confidence bound for the MVP - VVI 40 difference in average AT/AF burden from 24 to 36 months being less than 0.|Bootstrap Confidence Interval|||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.||0.110|-0.1|
71721572|NCT00281099|142959964|SUPERIORITY_OR_OTHER|||||||0.0053||95.0||||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.|Log Rank|||Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.||||0.0053
71769265|NCT00992589|143038900|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.449||||0.168|TWO_SIDED|95.0|-1.087|0.19|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in daily average frequency of regurgitation from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.190|-1.087|0.168
71769266|NCT00992589|143038901|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.03||||0.44|TWO_SIDED|95.0|-0.047|0.108|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Double-blind (DB) Baseline as covariate to test the hypothesis of no difference in change in Weight-for-Age Z-Score from DB Baseline to DB Endpoint between Rabeprazole Sodium Total and Placebo.||0.108|-0.047|0.440
71769267|NCT00992589|143038903|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.006||||0.984|TWO_SIDED|95.0|-0.619|0.632|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Regurgitation Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.632|-0.619|0.984
71769268|NCT00992589|143038904|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.182||||0.479|TWO_SIDED|95.0|-0.69|0.325|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Discomfort Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.325|-0.690|0.479
71769269|NCT00992589|143038905|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.192||||0.498|TWO_SIDED|95.0|-0.751|0.366|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Eating Behavior Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||0.366|-0.751|0.498
71887550|NCT00091832|143295968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.74|0.68|
71769270|NCT00992589|143038906|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.042||||0.96|TWO_SIDED|95.0|-1.615|1.7|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in I-GERQ-R Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.700|-1.615|0.960
71657079|NCT02944383|142831654|SUPERIORITY|||||||0.4225||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4225
71769271|NCT00992589|143038907|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.024||||0.968|TWO_SIDED|95.0|-1.167|1.214|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in Weekly Average I-GERQ-DD Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.||1.214|-1.167|0.968
71769272|NCT02142387|143038913|OTHER|||||||0.34|TWO_SIDED|95.0|||||Chi-squared|||||||0.34
71769273|NCT02142387|143038914|OTHER|||||||0.7|||||||Chi-squared|||||||0.7
71769274|NCT02142387|143038915|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
71769275|NCT05028361|143038916|NON_INFERIORITY|One-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-5.6||||0.0007|TWO_SIDED|95.0|-15.2|4.0||The upper limit of the 95% CI of the difference was 4% with a noninferiority margin of 10%.|Cochran-Mantel-Haenszel|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting was used.||The null hypothesis is the Simultaneous group is inferior (i.e., Simultaneous group will have a higher proportion) to the Sequential group in regards to the proportion of participants with at least one moderate or severe fever, chills, myalgia, or arthralgia event after visits 1 and 2 using 10% non-inferiority margin.||4.0|-15.2|0.0007
71769276|NCT05028361|143038917|SUPERIORITY|||||||0.3851|||||||Mantel Haenszel|||||||0.3851
71769277|NCT05028361|143038918|SUPERIORITY|||||||0.2886|||||||Mantel Haenszel|||||||0.2886
71657080|NCT02944383|142831654|SUPERIORITY|||||||0.7687||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7687
71657081|NCT02944383|142831654|SUPERIORITY|||||||0.0437||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0437
71721573|NCT00281099|142959966|SUPERIORITY_OR_OTHER|||||||0.9791||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.||||0.9791
71721574|NCT00281099|142959966|SUPERIORITY_OR_OTHER|||||||0.8984||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 12 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.||||0.8984
71721575|NCT00281099|142959966|SUPERIORITY_OR_OTHER|||||||0.7144||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 24 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.7144
71721576|NCT00281099|142959966|SUPERIORITY_OR_OTHER|||||||0.5165||95.0||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP \& no pacing indication have less mean ventricular pacing through 36 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.||||0.5165
71721577|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.0073||95.0||||The p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0073
71887551|NCT00091832|143295968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||||95.0|0.71|1.83|||||A hazard ratio \>1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.|||1.83|0.71|
71769278|NCT05028361|143038920|OTHER||Comparison of Frequencies|-0.01|||||TWO_SIDED|95.0|-1.66|1.64||The comparison in number of participants with reported SAEs regardless of relationship to study product were made using a difference in proportions along with a 95% confidence interval of the difference.||||||1.64|-1.66|
71769279|NCT01848782|143038921|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.5
71887552|NCT00091832|143295979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||||95.0|0.159|1.856|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.856|0.159|
71887553|NCT00091832|143295979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.544||||||95.0|0.159|1.859|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.859|0.159|
71887554|NCT00091832|143295979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.791||||||95.0|0.266|2.355|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.355|0.266|
71887555|NCT00091832|143295979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||||95.0|0.389|2.963|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||2.963|0.389|
71887556|NCT00091832|143295979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||||95.0|0.158|1.847|||||A hazard ratio \<1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.|||1.847|0.158|
71887557|NCT00091832|143295980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||||95.0|0.51|7.17|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.17|0.51|
71887558|NCT00091832|143295980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||||95.0|0.36|3.97|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||3.97|0.36|
71887559|NCT00091832|143295980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||||95.0|0.26|2.52|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||2.52|0.26|
71887560|NCT00091832|143295980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
71887561|NCT00091832|143295980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||7.05|0.5|
71887562|NCT00874250|143295982|SUPERIORITY_OR_OTHER||Proportion|0.98||||0.0024|TWO_SIDED|95.0|0.895|0.996|||Binomial Test|||||0.996|0.895|0.0024
71887563|NCT00695565|143296060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.168|TWO_SIDED|95.0|||||Mixed Models Analysis|||This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).||||0.168
71887564|NCT00695565|143296060|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|||||Mixed Models Analysis|||"Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.~This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2."||||0.014
71721578|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.2493||95.0||||No adjustment was made for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.2493
71721579|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.7728||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.7728
71721580|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.3082||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.3082
71721581|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.5422||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.5422
71769280|NCT01848782|143038922|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||||0.6|-0.5|0.8
71769281|NCT01848782|143038923|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||||0.7|-0.4|0.6
71769282|NCT01848782|143038924|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.8
71769283|NCT01848782|143038925|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.2
71721582|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.0851||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0851
71721583|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.0502||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0502
71769284|NCT01029405|143038937|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||<0.001
71769285|NCT02108262|143038953|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|1.0|||=|0.1241|TWO_SIDED|95.0|-0.1|2.5|||Newcombe-Wilson score method|||||2.5|-0.1|= 0.1241
71769286|NCT02108262|143038953|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.4994|TWO_SIDED|95.0|-0.5|1.7|||Newcombe-Wilson score method|||||1.7|-0.5|= 0.4994
71769287|NCT02108262|143038954|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|-0.2|||=|0.4988|TWO_SIDED|95.0|-1.4|0.7|||Newcombe-Wilson score method|||||0.7|-1.4|= 0.4988
71769288|NCT02108262|143038954|NON_INFERIORITY|The calculation used a non-inferiority argument powering the test of the alternative hypothesis of no difference in the rates. Within each co-primary endpoint, the two active treatment groups are assumed to have the same endpoint rates. Total alpha is 0.05 with 0.025 allocated to each co-primary endpoint, which in turn involves comparisons of two active treatment groups to placebo without further alpha control.|Difference in event rates (%)|0.5|||=|0.6241|TWO_SIDED|95.0|-0.7|1.9|||Newcombe-Wilson score method|||||1.9|-0.7|= 0.6241
71769289|NCT02108262|143038955|OTHER||Hazard Ratio (HR)|1.18|||=|0.5733|TWO_SIDED|95.0|0.67|2.05||Stratified log-rank p-value|Log Rank|||||2.05|0.67|= 0.5733
71769290|NCT02108262|143038955|OTHER||Hazard Ratio (HR)|1.02|||=|0.9717|TWO_SIDED|95.0|0.57|1.8||Stratified log-rank p-value|Log Rank|||||1.80|0.57|= 0.9717
71769291|NCT01860846|143039019|SUPERIORITY_OR_OTHER||||||=|0.004||||||Baseline vs. 12 months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||=0.004
71769292|NCT01860846|143039020|SUPERIORITY_OR_OTHER||||||=|0.022||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.022
71769293|NCT01860846|143039021|SUPERIORITY_OR_OTHER||||||=|0.006||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||= 0.006
71769294|NCT01860846|143039022|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.||||< 0.001
71769295|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Physical Functioning Scores: the null hypothesis was set as no difference.||||< 0.001
71769296|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Physical Scores: the null hypothesis was set as no difference.||||< 0.001
71769297|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||=|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Emotional Scores: the null hypothesis was set as no difference.||||= 0.001
71721584|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.0463||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0463
71721585|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.0227||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0227
71721586|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.0582||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.||||0.0582
71721587|NCT00281099|142959967|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all ten KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|||The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.||||> 0.15
71721588|NCT00281099|142959967|SUPERIORITY_OR_OTHER||||||>|0.15||95.0||||Tests for all 10 KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in these analyses.||The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.||||> 0.15
71721589|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.1399||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.||||0.1399
71721590|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.3573||95.0||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.||||0.3573
71721591|NCT00281099|142959967|SUPERIORITY_OR_OTHER|||||||0.5183||95.0||||The a priori threshold for statistical significance was 0.05, with no adjustment made for multiple comparisons.|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in this analysis.||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.||||0.5183
71721592|NCT00281099|142959968|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.44. The one-sided upper confidence bound for the hazard ratio had to be less than 1.44 for the null hypothesis to be rejected. The threshold of 1.44 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month survival rates.|Hazard Ratio (HR)|1.26||||||95.0|1.26|1.75|||||This was a non-inferiority analysis, and so a one-sided 95% confidence interval was performed comparing the MVP arm to the VVI 40 arm.|The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.||1.75|1.26|
71721593|NCT04621240|142959970|SUPERIORITY|Mean level change from pre- to post-testing|Mean Difference (Net)|10.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71721594|NCT04621240|142959970|OTHER|Regression of the change in BrainHealth Index on age|Slope|0.03||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
71721595|NCT06899737|142959976|SUPERIORITY||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|2.56||0.32|TWO_SIDED|95.0|-7.64|2.55|||t-test, 2 sided|||||2.55|-7.64|0.32
71721596|NCT06899737|142959977|SUPERIORITY||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|3.08||0.18|TWO_SIDED|95.0|-1.94|10.3|||t-test, 2 sided|||||10.30|-1.94|0.18
71721597|NCT06899737|142959978|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|95.0|-0.81|1.18|||t-test, 2 sided|||||1.18|-0.81|0.71
71721598|NCT06899737|142959979|SUPERIORITY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.32||0.32|TWO_SIDED|95.0|-0.03|1.24|||t-test, 2 sided|||||1.24|-0.03|0.32
71721599|NCT06899737|142959980|SUPERIORITY||Median Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.44||0.91|TWO_SIDED|95.0|-0.82|0.92|||t-test, 2 sided|||||0.92|-0.82|0.91
71721600|NCT06899737|142959981|SUPERIORITY||Median Difference (Final Values)|0.69||||0.059|TWO_SIDED|95.0|-0.03|1.42|||t-test, 2 sided|||||1.42|-0.03|0.059
71769298|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||=|0.019||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Vitality Scores: the null hypothesis was set as no difference.||||= 0.019
71769299|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||=|0.017||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Mental Health Scores: the null hypothesis was set as no difference.||||= 0.017
71721601|NCT06899737|142959982|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.79|TWO_SIDED|95.0|-0.92|0.71|||t-test, 2 sided|||||0.71|-0.92|0.79
71721602|NCT06899737|142959983|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.33||0.14|TWO_SIDED|95.0|-0.16|1.15|||t-test, 2 sided|||||1.15|-0.16|0.14
71721603|NCT06899737|142959984|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.43||0.42|TWO_SIDED|95.0|-1.19|0.5|||t-test, 2 sided|||||0.50|-1.19|0.42
71721604|NCT06899737|142959985|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.37||0.37|TWO_SIDED|95.0|-0.4|1.07|||t-test, 2 sided|||||1.07|-0.40|0.37
71721605|NCT06899737|142959987|SUPERIORITY||Mean Difference (Final Values)|6.72|STANDARD_ERROR_OF_MEAN|3.42||0.05|TWO_SIDED|95.0|-0.06|13.51|||t-test, 2 sided|||||13.51|-0.06|0.05
71721606|NCT06899737|142959988|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.35||0.23|TWO_SIDED|95.0|-0.26|1.11|||t-test, 2 sided|||||1.11|-0.26|0.23
71721607|NCT06899737|142959989|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.08|TWO_SIDED|95.0|-0.09|1.39|||t-test, 2 sided|||||1.39|-0.09|0.08
71721608|NCT06899737|142959990|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.38||0.11|TWO_SIDED|95.0|-0.15|1.35|||t-test, 2 sided|||||1.35|-0.15|0.11
71721609|NCT06899737|142959991|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.34||0.05|TWO_SIDED|95.0|-0.01|1.36|||t-test, 2 sided|||||1.36|-0.01|0.05
71721610|NCT00501592|142960082|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 25 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.040
71721611|NCT00501592|142960082|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT-747 50 mg using t-tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.||||0.28
71721612|NCT00501592|142960083|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||t-test, 2 sided|||||||0.0031
71721613|NCT00501592|142960083|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
71721614|NCT00501592|142960083|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
71721615|NCT00501592|142960083|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
71721616|NCT01525862|142960086|SUPERIORITY||||||<|0.0001||||||P values \<0.05 are considered statistically significant.|t-test, 2 sided|||||||<0.0001
71721617|NCT01804049|142960101|SUPERIORITY|Hypothesis: metformin will reduce loss of total lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.45||||||For lean total body mass, t(118)=0.744, p=0.45.|t-test, 2 sided|T-test calculation for total lean mass: 0.74.||||||0.45
71721618|NCT01804049|142960101|SUPERIORITY|Hypothesis: metformin will reduce loss of total appendicular lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.79||||||For lean appendicular body mass, t(118) = 0.264, p=0.79.|t-test, 2 sided|T-test calculation appendicular lean mass: 0.26.||||||0.79
71721619|NCT01804049|142960102|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|t(118)=0.703, p=0.48||||||0.48
71769300|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||=|0.007||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Functioning Scores: the null hypothesis was set as no difference.||||= 0.007
71721620|NCT01147250|142960104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.3.|Hazard Ratio (HR)|1.017|||||TWO_SIDED|95.0|0.886|1.168|||||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).||1.168|0.886|
71721621|NCT01147250|142960104|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.8542|TWO_SIDED|95.0|0.886|1.168|||Log Rank||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was \<1.0.||1.168|0.886|0.8542
71721622|NCT03588806|142960108|SUPERIORITY|||||||0.218|||||||ANOVA|Univariate repeated measures ANOVA||||||0.218
71721623|NCT03588806|142960109|SUPERIORITY|||||||0.268|||||||ANOVA|Univariate repeated measures||||||0.268
71769301|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bodily Pain Scores: the null hypothesis was set as no difference.||||< 0.001
71769302|NCT01860846|143039023|SUPERIORITY_OR_OTHER||||||=|0.005||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||General Health Scores: the null hypothesis was set as no difference.||||= 0.005
71721624|NCT03588806|142960110|SUPERIORITY||||||<|0.001|||||||ANOVA|Univariate repeated measures ANOVA||||||<0.001
71721625|NCT03588806|142960111|SUPERIORITY|||||||0.228|||||||ANOVA|Univariate repeated measures ANOVA||||||0.228
71721626|NCT03588806|142960112|SUPERIORITY|||||||0.043|||||||ANOVA|Univariate repeated measures ANOVA||||||0.043
71721627|NCT03588806|142960113|SUPERIORITY|||||||0.486|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Social Roles score||||0.486
71721628|NCT03588806|142960113|SUPERIORITY|||||||0.078|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Sleep Disturbance T-Scores||||0.078
71721629|NCT03588806|142960113|SUPERIORITY|||||||0.874|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Depression T-Scores||||0.874
71721630|NCT03588806|142960113|SUPERIORITY|||||||0.389|||||||ANOVA|Univariate repeated measures ANOVA||PROMIS Anxiety T-Score||||0.389
71721631|NCT03588806|142960114|SUPERIORITY|||||||0.676|||||||ANOVA|Univariate repeated measures ANOVA||||||0.676
71721632|NCT03985943|142960117|OTHER||Strata-adjusted percentage difference|11.5||||0.0003|TWO_SIDED|97.5|4.7|18.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.3|4.7|0.0003
71769303|NCT01860846|143039024|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bowel-related Symptoms Scores: The null hypothesis was set as no difference.||||< 0.001
71721633|NCT03985943|142960118|OTHER||Strata-adjusted percentage difference|14.3||||0.0002|TWO_SIDED|97.5|6.1|22.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.5|6.1|0.0002
71721634|NCT03985943|142960119|OTHER||Strata-adjusted percentage difference|14.9|||<|0.0001|TWO_SIDED|97.5|7.8|22.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.0|7.8|<0.0001
71721635|NCT03985943|142960120|OTHER||Strata-adjusted percentage difference|18.1|||<|0.0001|TWO_SIDED|97.5|9.6|26.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.6|9.6|<0.0001
71721636|NCT03985943|142960121|OTHER||Strata-adjusted percentage difference|24.9|||<|0.0001|TWO_SIDED|97.5|18.4|31.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||31.5|18.4|<0.0001
71721637|NCT03985943|142960121|OTHER||Strata-adjusted percentage difference|28.1|||<|0.0001|TWO_SIDED|97.5|22.0|34.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.3|22.0|<0.0001
71887565|NCT01462266|143296074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.009|TWO_SIDED|95.0|-8.3|-1.2|||Longitudinal data analysis|Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)||||-1.2|-8.3|0.009
71721638|NCT03985943|142960122|OTHER||Strata-adjusted percentage difference|27.5|||<|0.0001|TWO_SIDED|97.5|19.4|35.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||35.7|19.4|<0.0001
71721639|NCT03985943|142960122|OTHER||Strata-adjusted percentage difference|32.1|||<|0.0001|TWO_SIDED|97.5|24.4|39.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||39.8|24.4|<0.0001
71721640|NCT03985943|142960123|OTHER||Strata-adjusted percentage difference|19.5|||<|0.0001|TWO_SIDED|97.5|13.7|25.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.2|13.7|<0.0001
71721641|NCT03985943|142960124|OTHER||Strata-adjusted percentage difference|20.3|||<|0.0001|TWO_SIDED|97.5|13.8|26.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.8|13.8|<0.0001
71721642|NCT03985943|142960125|OTHER||Strata-adjusted percentage difference|17.9|||<|0.0001|TWO_SIDED|97.5|11.3|24.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.5|11.3|<0.0001
71721643|NCT03985943|142960126|OTHER||Strata-adjusted percentage difference|19.7|||<|0.0001|TWO_SIDED|97.5|11.2|28.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||28.2|11.2|<0.0001
71887566|NCT01106846|143296079|SUPERIORITY_OR_OTHER|||||||0.947|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.947
71887567|NCT02419508|143296087|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71887568|NCT02419508|143296088|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71887569|NCT02419508|143296089|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71887570|NCT02419508|143296090|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71721644|NCT03985943|142960127|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.8|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26|15.8|<0.0001
71721645|NCT03985943|142960128|OTHER||Strata-adjusted percentage difference|21.2|||<|0.0001|TWO_SIDED|97.5|14.8|27.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||27.6|14.8|<0.0001
71721646|NCT03985943|142960129|OTHER||Strata-adjusted percentage difference|12.2|||<|0.0001|TWO_SIDED|97.5|8.2|16.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||16.3|8.2|<0.0001
71721647|NCT03985943|142960130|OTHER||Strata-adjusted percentage difference|9.7|||<|0.0001|TWO_SIDED|97.5|5.2|14.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.2|5.2|<0.0001
71721648|NCT03985943|142960131|OTHER||Strata-adjusted percentage difference|14.6|||<|0.0001|TWO_SIDED|97.5|10.6|18.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||18.7|10.6|<0.0001
71721649|NCT03985943|142960132|OTHER||Strata-adjusted percentage difference|16.9|||<|0.0001|TWO_SIDED|97.5|11.5|22.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.3|11.5|<0.0001
71721650|NCT03985943|142960133|OTHER||Strata-adjusted percentage difference|3.4||||0.0064|TWO_SIDED|97.5|1.1|5.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||5.8|1.1|0.0064
71721651|NCT03985943|142960134|OTHER||Strata-adjusted percentage difference|4.3||||0.0177|TWO_SIDED|97.5|0.9|7.7||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||7.7|0.9|0.0177
71721652|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Specificity of lesion shape|0.694|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||Null hypothesis is that there is no difference between the two tests.||||<0.001
71721653|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, conservative|0.714|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71721654|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Lesion homogeneity spec, agressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71769304|NCT01860846|143039024|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Systemic Symptoms Scores:The null hypothesis was set as no difference.||||< 0.001
71769305|NCT01860846|143039024|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Emotional Function Scores: the null hypothesis was set as no difference.||||< 0.001
71769306|NCT01860846|143039024|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Function Scores: The null hypothesis was set as no difference.||||< 0.001
71887571|NCT02419508|143296091|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71887572|NCT02419508|143296092|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71721655|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Max. elasticity specificity,conservative|0.657||||0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.001
71721656|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Max. elasticity specificity, aggressive|0.774|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71721657|NCT00716482|142960158|SUPERIORITY_OR_OTHER||median mean elasticity value specificity|0.626||||0.18|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.18
71721658|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Diameter ratio specificity|0.512||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
71721659|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Median elasticity ratio specificity|0.649||||0.006|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.006
71721660|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Max.color scale specificity,conservative|0.703|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71721661|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Max. color scale specificity, aggressive|0.785|||<|0.001|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall specificity = 78.5%"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||<0.001
71721662|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Lesion shape sensitivity|0.979||||0.48|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image lesion shape.~Null hypothesis is that there is no difference between the two tests."||||0.48
71721663|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Lesion homogeneity sens, conservative|0.969||||0.74|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.74
71721664|NCT00716482|142960158|SUPERIORITY_OR_OTHER||elasticity homogeneity,aggressive,sensit|0.962||||0.37|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."||||0.37
71829752|NCT03622593|143163796|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg Q8W and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg Q8W was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-0.1|3.2|||||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|
71887573|NCT02419508|143296093|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71887574|NCT01332071|143296098|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.58|||||TWO_SIDED|90.0|93.44|99.83|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.83|93.44|
71721665|NCT00716482|142960158|SUPERIORITY_OR_OTHER||elasticity homegeneity,conservative,sens|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall sensitivity = 99.0%"|McNemar|||"Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||0.025
71721666|NCT00716482|142960158|SUPERIORITY_OR_OTHER||max. elasticity sensitivity,aggressive|0.972|||>|0.99|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."||||>0.99
71721667|NCT00716482|142960158|SUPERIORITY_OR_OTHER||median mean elasticity value sensitivity|0.986||||0.046|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."||||0.046
71721668|NCT00716482|142960158|SUPERIORITY_OR_OTHER||diameter ratio sensitivity|0.99||||0.025|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."||||0.025
71721669|NCT00716482|142960158|SUPERIORITY_OR_OTHER||median elasticity ratio sensitivity|0.983||||0.083|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."||||0.083
71721670|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Max.color scale sensitivity,conservative|0.997||||0.008|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."||||0.008
71721671|NCT00716482|142960158|SUPERIORITY_OR_OTHER||Max. color scale sensitivity, aggressive|0.986||||0.21|TWO_SIDED|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."||||0.21
71721672|NCT00716482|142960159|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Kruskal-Wallis one-way ANOVA. Kruskal-Wallis was performed once to get p-values for all of the 9 categories at once.||Null hypothesis: no variance of similarity exists between the three groups||||<0.001
71721673|NCT01092780|142960162|SUPERIORITY_OR_OTHER||Difference in LS means|8.16|||||TWO_SIDED|95.0|6.11|10.2||||||Difference in least squares (LS) means||10.20|6.11|
71721674|NCT01092780|142960162|SUPERIORITY_OR_OTHER||Difference in LS means|8.11|||||TWO_SIDED|95.0|6.07|10.15||||||Difference in LS means||10.15|6.07|
71721675|NCT01092780|142960163|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.1|-0.05||||||Difference in LS means||-0.05|-0.10|
71721676|NCT01092780|142960163|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.09|-0.05||||||Difference in LS means||-0.05|-0.09|
71769307|NCT01856764|143039027|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.496||0.276|TWO_SIDED|95.0|-1.5542|0.4574||Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score|Mixed Models Analysis|||||0.4574|-1.5542|0.276
71769308|NCT01856764|143039028|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.91|STANDARD_ERROR_OF_MEAN|3.454||0.095|TWO_SIDED|95.0|-12.9134|1.0835||MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score|Mixed Models Analysis|||||1.0835|-12.9134|0.095
71721677|NCT01092780|142960165|SUPERIORITY_OR_OTHER||Difference in LS means|-2.05|||||TWO_SIDED|90.0|-3.76|-0.35||||||Difference in LS means||-0.35|-3.76|
71721678|NCT01092780|142960165|SUPERIORITY_OR_OTHER||Difference in LS means|-2.1|||||TWO_SIDED|90.0|-3.79|-0.4||||||Difference in LS means||-0.40|-3.79|
71721679|NCT01092780|142960166|SUPERIORITY_OR_OTHER||Difference in LS means|10.21|||||TWO_SIDED|90.0|8.49|11.92||||||||11.92|8.49|
71721680|NCT01092780|142960167|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|90.0|-0.08|-0.05||||||Difference in LS means||-0.05|-0.08|
71721681|NCT01864148|142960168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9584|TWO_SIDED|95.0|0.46|2.07|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.07|0.46|0.9584
71721682|NCT01864148|142960168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0636|TWO_SIDED|95.0|0.97|3.31|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.31|0.97|0.0636
71721683|NCT01864148|142960168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.022|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||3.84|1.11|0.0220
71721684|NCT01864148|142960168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1771|TWO_SIDED|95.0|0.36|1.21|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.21|0.36|0.1771
71721685|NCT01864148|142960168|SUPERIORITY_OR_OTHER|||||||0.8931|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.8931
71721686|NCT01864148|142960169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.3058|TWO_SIDED|95.0|0.28|1.49|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.49|0.28|0.3058
71721687|NCT01864148|142960169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.1873|TWO_SIDED|95.0|0.81|2.89|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.89|0.81|0.1873
71721688|NCT01864148|142960169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.2766|TWO_SIDED|95.0|0.76|2.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||2.65|0.76|0.2766
71721689|NCT01864148|142960169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6578|TWO_SIDED|95.0|0.45|1.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.||||1.65|0.45|0.6578
71721690|NCT01864148|142960169|SUPERIORITY_OR_OTHER|||||||0.5255|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.||||||0.5255
71721691|NCT03587428|142960176|SUPERIORITY||Mean Difference (Final Values)|-0.3252||||0.1787|TWO_SIDED|95.0|-0.8101|0.1596|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||0.1596|-0.8101|0.1787
71721692|NCT03587428|142960176|SUPERIORITY||Mean Difference (Final Values)|-0.7037||||0.0063|TWO_SIDED|95.0|-1.1886|-0.2187|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.|||-0.2187|-1.1886|0.0063
71769309|NCT01856764|143039029|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.596||0.013|TWO_SIDED|95.0|-2.7656|-0.3492||MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score|Mixed Models Analysis|||||-0.3492|-2.7656|0.013
71769310|NCT05072470|143039041|SUPERIORITY|When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|||||<|0.01|||||||t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at 0 dB SNR||||<0.01
71769311|NCT05072470|143039041|SUPERIORITY|||||||0.031||||||When p value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be better with hearing aids plus Roger device, than with hearing aids alone when tested using standardized speech test at -5 dB SNR||||.031
71769312|NCT05072470|143039041|SUPERIORITY|||||||0.046||||||When p-values are adjusted for multiple comparisons, the level of statistical significance must be \</= .01666667 (.05/3)|t-test, 2 sided|||Speech intelligibility will be equal or better with hearing aids plus Roger device than with hearing aids alone when tested using standardized speech test at +5 dB SNR.||||.046
71769313|NCT03039621|143039060|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance equals 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
71769314|NCT03039621|143039061|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
71721693|NCT04004221|142960182|OTHER||||||<|0.0001|||||||Exact Binomial Test|1-sided p-value was based on binomial exact test of Tislelizumab versus historical rate of 0.1||||||< 0.0001
71721694|NCT02689206|142960195|OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.31|1.45|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 10 mg arm from Placebo along with 95 percent CI are presented.|||1.45|-0.31|
71721695|NCT02689206|142960195|OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-0.4|1.42|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 15 mg arm from Placebo along with 95 percent CI are presented.|||1.42|-0.40|
71721696|NCT02689206|142960195|OTHER||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|0.59|2.35|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 25 mg arm from Placebo along with 95 percent CI are presented.|||2.35|0.59|
71721697|NCT02689206|142960195|OTHER||Mean Difference (Final Values)|1.67|||||TWO_SIDED|95.0|0.77|2.57|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment\*time. Model-adjusted treatment difference of dapro 30 mg arm from Placebo along with 95 percent CI are presented.|||2.57|0.77|
71721698|NCT00595881|142960241|SUPERIORITY_OR_OTHER||Difference in sensitivity|-1.7|||||TWO_SIDED|95.0|-3.4|0.0||"We calculated the differences between the sensitivities and specificities. The difference in sensitivity between the clinical exam alone vs clinical exam + ultrasound was -1.7% (-3.4%, 0%).~The difference in specificity was -2.8% (-9.7%, 4.1%)."|Mixed effects logistic regression|We used the bootstrap method to obtain valid confidence intervals and compare sensitivity and specificity for the 2 tests.|The clinical exam alone was compared to the clinical exam + ultrasound.|See sample size calculations already entered. Null hypothesis is that there is no difference in the sensitivity or specificity of clinical exam alone compared with clinical exam+ultrasound.||0|-3.4|
71721699|NCT00595881|142960241|SUPERIORITY_OR_OTHER||Difference in specificity|-2.8||||||95.0|-9.7|4.1||Statistical significance was defined as a CI surrounding the difference between groups not including 0.||as previously described for sensitivity||as previously described for sensitivity||4.1|-9.7|
71769315|NCT03039621|143039062|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
71769316|NCT03039621|143039063|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71721700|NCT01479764|142960242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.059|||Pearson's Chi-square test|||Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.||0.059|0.000|<0.0001
71721701|NCT01479764|142960243|SUPERIORITY_OR_OTHER||Estimated Ratio of Geometric Means|0.83||||0.021|TWO_SIDED|95.0|0.71|0.97|||ANCOVA|Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index \& length of surgical procedure||Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.||0.97|0.71|0.021
71721702|NCT00260832|142960246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1079|TWO_SIDED|95.0|||||Kaplan-Meier|||The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status||||0.1079
71721703|NCT00260832|142960247|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0011|TWO_SIDED|95.0|1.4|4.78|||Fisher Exact|||||4.78|1.40|0.0011
71721704|NCT03745638|142960248|SUPERIORITY||Odds Ratio (OR)|6.38|||<|0.0001|TWO_SIDED|95.0|3.556|11.923||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||11.923|3.556|< 0.0001
71721705|NCT03745638|142960248|SUPERIORITY||Odds Ratio (OR)|7.5|||<|0.0001|TWO_SIDED|95.0|4.178|14.04||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||14.040|4.178|< 0.0001
71721706|NCT03745638|142960249|SUPERIORITY||Odds Ratio (OR)|4.04|||<|0.0001|TWO_SIDED|95.0|2.441|6.808||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.808|2.441|< 0.0001
71721707|NCT03745638|142960249|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.0001|TWO_SIDED|95.0|3.145|8.831||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.831|3.145|< 0.0001
71887575|NCT01332071|143296099|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.76|||||TWO_SIDED|90.0|93.25|102.5|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.50|93.25|
71721708|NCT03745638|142960250|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0002|TWO_SIDED|95.0|1.773|8.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||8.083|1.773|0.0002
71721709|NCT03745638|142960250|SUPERIORITY||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|2.931|13.22||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.220|2.931|< 0.0001
71721710|NCT03745638|142960251|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0081|TWO_SIDED|95.0|1.242|5.723||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||5.723|1.242|0.0081
71721711|NCT03745638|142960251|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0039|TWO_SIDED|95.0|1.334|6.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||6.083|1.334|0.0039
71721712|NCT03745638|142960252|SUPERIORITY||Odds Ratio (OR)|1.67||||0.1421|TWO_SIDED|95.0|0.862|3.391||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.391|0.862|0.1421
71721713|NCT03745638|142960252|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0746|TWO_SIDED|95.0|0.949|3.665||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.665|0.949|0.0746
71721714|NCT03745638|142960262|SUPERIORITY||Least Squares Mean Difference|-35.48|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-43.64|-27.32|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-27.32|-43.64|< 0.0001
71721715|NCT03745638|142960262|SUPERIORITY||Least Squares Method of Mean Difference]|-40.29|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|-48.44|-32.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-32.13|-48.44|< 0.0001
71721716|NCT03745638|142960262|SUPERIORITY||Least Squares Mean Difference|-45.01|STANDARD_ERROR_OF_MEAN|4.72|<|0.0001|TWO_SIDED|95.0|-54.28|-35.74|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.74|-54.28|< 0.0001
71721717|NCT03745638|142960262|SUPERIORITY||Least Squares Mean Difference|-48.05|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-57.3|-38.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-38.79|-57.30|< 0.0001
71721718|NCT03745638|142960262|SUPERIORITY||Least Squares Mean Difference|-33.13|STANDARD_ERROR_OF_MEAN|4.49|<|0.0001|TWO_SIDED|95.0|-41.95|-24.3||The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.|Mixed-Model with Repeated Measures|||Percent change from Baseline in EASI score at Week 8||-24.30|-41.95|< 0.0001
71721719|NCT03745638|142960262|SUPERIORITY||Least Squares Mean Difference|-39.52|STANDARD_ERROR_OF_MEAN|4.48|<|0.0001|TWO_SIDED|95.0|-48.32|-30.72|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-30.72|-48.32|< 0.0001
71769317|NCT03039621|143039064|SUPERIORITY|||||||0.0201||||||"The p-value associated with treatment factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0201
71721720|NCT03745638|142960263|SUPERIORITY||Least Squares Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-32.62|-17.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-17.95|-32.62|< 0.0001
71721721|NCT03745638|142960263|SUPERIORITY||Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-37.68|-23.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-23.06|-37.68|< 0.0001
71721722|NCT03745638|142960264|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-1.87|-0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-0.91|-1.87|<0.0001
71721723|NCT03745638|142960264|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.11|-1.16|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.16|-2.11|<0.0001
71721724|NCT03745638|142960264|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.25|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.15|-2.25|<0.0001
71721725|NCT03745638|142960264|SUPERIORITY||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.63|-1.53|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.53|-2.63|<0.0001
71721726|NCT03745638|142960264|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.01|-2.20|<0.0001
71721727|NCT03745638|142960264|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.58|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.40|-2.58|<0.0001
71721728|NCT03745638|142960266|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.74|-0.74|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.74|-1.74|<0.0001
71721729|NCT03745638|142960266|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.11|-1.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-1.13|-2.11|<0.0001
71721730|NCT03745638|142960269|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.54||0.0049|TWO_SIDED|95.0|-2.6|-0.47|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-0.47|-2.60|0.0049
71721731|NCT03745638|142960269|SUPERIORITY||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.54|<|0.0001|TWO_SIDED|95.0|-3.37|-1.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||-1.25|-3.37|<0.0001
71721732|NCT03745638|142960269|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.6||0.0001|TWO_SIDED|95.0|-3.52|-1.15|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.15|-3.52|0.0001
71721733|NCT03745638|142960269|SUPERIORITY||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.03|-1.67|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||-1.67|-4.03|<0.0001
71721734|NCT03745638|142960269|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.71||0.0004|TWO_SIDED|95.0|-3.93|-1.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.14|-3.93|0.0004
71721735|NCT03745638|142960269|SUPERIORITY||Least Squares Mean Difference|-3.18|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-4.57|-1.79|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||-1.79|-4.57|<0.0001
71721736|NCT03745638|142960270|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.6||0.0487|TWO_SIDED|95.0|-2.35|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.35|0.0487
71721737|NCT03745638|142960270|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.59||0.0049|TWO_SIDED|95.0|-2.84|-0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.51|-2.84|0.0049
71769318|NCT03039621|143039065|SUPERIORITY|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71769319|NCT03039621|143039066|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
71769320|NCT03039621|143039066|OTHER|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.22|||||||Breslow-Day test|||||||0.22
71721738|NCT03745638|142960270|SUPERIORITY||Least Squares Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.66||0.0128|TWO_SIDED|95.0|-2.94|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.94|0.0128
71657082|NCT02944383|142831654|SUPERIORITY|||||||0.2735||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2735
71657083|NCT02944383|142831655|SUPERIORITY|||||||0.1042||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1042
71721739|NCT03745638|142960270|SUPERIORITY||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.66||0.0037|TWO_SIDED|95.0|-3.2|-0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.62|-3.20|0.0037
71657084|NCT02944383|142831655|SUPERIORITY|||||||0.6204||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6204
71657085|NCT02944383|142831655|SUPERIORITY|||||||0.8659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.8659
71657086|NCT02944383|142831655|SUPERIORITY|||||||0.9658||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9658
71657087|NCT02944383|142831655|SUPERIORITY|||||||0.8238||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8238
71721740|NCT03745638|142960270|SUPERIORITY||Least Squares Mean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.75||0.0048|TWO_SIDED|95.0|-3.58|-0.65|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.65|-3.58|0.0048
71721741|NCT03745638|142960270|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.74||0.002|TWO_SIDED|95.0|-3.75|-0.84|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||-0.84|-3.75|0.0020
71657088|NCT02944383|142831655|SUPERIORITY|||||||0.4874||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4874
71657089|NCT02944383|142831655|SUPERIORITY|||||||0.9467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9467
71721742|NCT03745638|142960273|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.07|-2.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.18|-4.07|<0.0001
71721743|NCT03745638|142960273|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.67|-2.79|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.79|-4.67|<0.0001
71721744|NCT03745638|142960275|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-6.43|-3.8|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-3.80|-6.43|<0.0001
71721745|NCT03745638|142960275|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|-7.62|-5.0|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-5.00|-7.62|<0.0001
71721746|NCT03745638|142960277|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-4.85|-2.68|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.68|-4.85|<0.0001
71721747|NCT03745638|142960277|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-5.56|-3.42|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-3.42|-5.56|<0.0001
71721748|NCT03745638|142960279|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.01||0.0018|TWO_SIDED|95.0|-5.29|-1.26|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.26|-5.29|0.0018
71721749|NCT03745638|142960279|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0378|TWO_SIDED|95.0|-4.43|-0.13|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-0.13|-4.43|0.0378
71721750|NCT03745638|142960283|SUPERIORITY||Odds Ratio (OR)|6.28|||<|0.0001|TWO_SIDED|95.0|3.632|11.018||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||11.018|3.632|<0.0001
71721751|NCT03745638|142960283|SUPERIORITY||Odds Ratio (OR)|8.39|||<|0.0001|TWO_SIDED|95.0|4.755|15.083||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||15.083|4.755|<0.0001
71721752|NCT03745638|142960284|SUPERIORITY||Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|1.67||0.0037|TWO_SIDED|95.0|1.59|8.15|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.15|1.59|0.0037
71721753|NCT03745638|142960284|SUPERIORITY||Least Squares Mean Difference|5.7|STANDARD_ERROR_OF_MEAN|1.66||0.0006|TWO_SIDED|95.0|2.45|8.96|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.96|2.45|0.0006
71721754|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.34||0.1417|TWO_SIDED|95.0|-11.49|1.65|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.65|-11.49|0.1417
71721755|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|3.29||0.6037|TWO_SIDED|95.0|-8.19|4.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||4.77|-8.19|0.6037
71721756|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.99||0.0003|TWO_SIDED|95.0|-16.89|-5.12|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.12|-16.89|0.0003
71721757|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|2.93|<|0.0001|TWO_SIDED|95.0|-17.98|-6.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.47|-17.98|<0.0001
71721758|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|3.85|<|0.0001|TWO_SIDED|95.0|-22.95|-7.81|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.81|-22.95|<0.0001
71721759|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0011|TWO_SIDED|95.0|-19.85|-5.01|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.01|-19.85|0.0011
71721760|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|2.13|<|0.0001|TWO_SIDED|95.0|-14.64|-6.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.29|-14.64|<0.0001
71721761|NCT03745638|142960285|SUPERIORITY||Least Squares Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|-16.6|-8.29|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-8.29|-16.60|<0.0001
71721762|NCT01032603|142960289|SUPERIORITY||Difference in percentage of participants|9.0||||0.24|TWO_SIDED|95.0|-6.0|23.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=46%, RR group=37%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||23|-6|0.24
71721763|NCT01032603|142960290|SUPERIORITY||Difference in percentage of participants|8.0||||0.25|TWO_SIDED|95.0|-6.0|21.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=34%, RR group=26%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||21|-6|0.25
71721764|NCT01032603|142960291|SUPERIORITY||Difference in percentage of participants|-7.0||||0.06|TWO_SIDED|95.0|-14.0|0.23|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=3%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||0.23|-14|0.06
71721765|NCT01032603|142960292|SUPERIORITY||Difference in percentage of participants|4.0||||0.36|TWO_SIDED|95.0|-5.0|14.0|||Z test||Proportion of participants meeting criteria by 3 yrs was obtained by KM method. BLR group=14%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.|||14|-5|0.36
71721766|NCT01032603|142960294|SUPERIORITY|||||||0.44|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).||||0.44
71721767|NCT01032603|142960297|SUPERIORITY|||||||0.64|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).||||0.64
71721768|NCT01032603|142960300|SUPERIORITY|||||||0.21|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.21
71721769|NCT01032603|142960303|SUPERIORITY|||||||0.38|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.38
71887576|NCT01332071|143296100|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.47|||||TWO_SIDED|90.0|93.32|99.72|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.72|93.32|
71887577|NCT01332071|143296101|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|95.79|||||TWO_SIDED|90.0|91.67|100.1|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||100.10|91.67|
71887578|NCT01332071|143296102|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|94.86|||||TWO_SIDED|90.0|90.7|99.22|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||99.22|90.70|
71887579|NCT01332071|143296103|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency - ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.88|||||TWO_SIDED|90.0|93.15|102.86|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||102.86|93.15|
71887580|NCT01738971|143296104|SUPERIORITY_OR_OTHER||relative probability|3.13|||<|0.001||95.0|1.9|5.13|||t-test, 2 sided|see above description of analysis taking into account cluster randomisation||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control."||5.13|1.90|<0.001
71887581|NCT01738971|143296104|SUPERIORITY_OR_OTHER||relative probability|2.57||||0.006||95.0|1.55|4.27||see above comments regarding analysis taking cluster randomised account into consideration|t-test, 2 sided|||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control."||4.27|1.55|0.006
71887582|NCT00692211|143296128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.01|TWO_SIDED|95.0|1.04|2.32||Not adjusted for multiple comparisons, a priori threshold of 0.05|Regression, Logistic|||Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.||2.32|1.04|0.01
71887583|NCT05888103|143296136|SUPERIORITY||LS Mean Difference|-47.5|||<|0.0001|TWO_SIDED|95.0|-52.35|-42.65|||ANCOVA|||||-42.65|-52.35|<0.0001
71887584|NCT05888103|143296137|SUPERIORITY||LS Mean Difference|-69.73|||<|0.0001|TWO_SIDED|95.0|-76.6|-62.86|||ANCOVA|||||-62.86|-76.60|<0.0001
71887585|NCT05888103|143296138|SUPERIORITY||LS Mean Difference|-77.83|||<|0.0001|TWO_SIDED|95.0|-85.86|-69.8|||ANCOVA|||||-69.80|-85.86|<0.0001
71657090|NCT02944383|142831655|SUPERIORITY|||||||0.7467||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7467
71721770|NCT01032603|142960306|SUPERIORITY|||||||0.93|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.93
71887586|NCT05888103|143296139|SUPERIORITY||LS Mean Difference|-226.61|||<|0.0001|TWO_SIDED|95.0|-244.77|-208.45|||ANCOVA|||||-208.45|-244.77|<0.0001
71887587|NCT05888103|143296140|SUPERIORITY||LS Mean Difference|-31.49|||<|0.0001|TWO_SIDED|95.0|-34.91|-28.07|||ANCOVA|||||-28.07|-34.91|<0.0001
71657091|NCT02944383|142831655|SUPERIORITY||Median Difference (Net)|-0.41||||0.9081|TWO_SIDED|95.0|-10.77|10.75||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||10.75|-10.77|0.9081
71721771|NCT01032603|142960309|SUPERIORITY|||||||0.82|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.||||0.82
71769321|NCT03039621|143039067|SUPERIORITY|||||||0.0037||||||"The p-value associated with treatment factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0037
71769322|NCT03039621|143039068|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71887588|NCT05888103|143296141|SUPERIORITY||LS Mean Difference|-71.46|||<|0.0001|TWO_SIDED|95.0|-79.24|-63.69|||ANCOVA|||||-63.69|-79.24|<0.0001
71887589|NCT05888103|143296142|SUPERIORITY||LS Mean Difference|2.94||||0.3743|TWO_SIDED|95.0|-3.55|9.42|||ANCOVA|||||9.42|-3.55|0.3743
71887590|NCT05888103|143296143|SUPERIORITY||LS Mean Difference|1.07||||0.4228|TWO_SIDED|95.0|-1.54|3.68|||ANCOVA|||||3.68|-1.54|0.4228
71887591|NCT05888103|143296144|SUPERIORITY||LS Mean Difference|-40.57|||<|0.0001|TWO_SIDED|95.0|-44.57|-36.57|||ANCOVA|||||-36.57|-44.57|<0.0001
71887592|NCT05888103|143296145|SUPERIORITY||LS Mean Difference|-72.34|||<|0.0001|TWO_SIDED|95.0|-79.56|-65.13|||ANCOVA|||||-65.13|-79.56|<0.0001
71887593|NCT05888103|143296146|SUPERIORITY||LS Mean Difference|-36.84|||<|0.0001|TWO_SIDED|95.0|-40.72|-32.96|||ANCOVA|||||-32.96|-40.72|<0.0001
71887594|NCT05888103|143296147|SUPERIORITY||LS Mean Difference|-41.87|||<|0.0001|TWO_SIDED|95.0|-46.28|-37.47|||ANCOVA|||||-37.47|-46.28|<0.0001
71887595|NCT05888103|143296148|SUPERIORITY||LS Mean Difference|2.05||||0.3011|TWO_SIDED|95.0|-1.84|5.93|||ANCOVA|||||5.93|-1.84|0.3011
71887596|NCT05888103|143296149|SUPERIORITY||LS Mean Difference|3.13||||0.2403|TWO_SIDED|95.0|-2.09|8.35|||ANCOVA|||||8.35|-2.09|0.2403
71887597|NCT05888103|143296150|SUPERIORITY||LS Mean Difference|-30.27|||<|0.0001|TWO_SIDED|95.0|-40.58|-19.95|||ANCOVA|||||-19.95|-40.58|<0.0001
71721772|NCT01032603|142960311|SUPERIORITY|||||||0.3||||||Child 5 to 7 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.30
71721773|NCT01032603|142960311|SUPERIORITY|||||||0.77||||||Child 8 to 13 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.77
71721774|NCT01032603|142960311|SUPERIORITY|||||||0.51||||||Parent Proxy IXTQ|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.51
71721775|NCT01032603|142960311|SUPERIORITY|||||||0.42||||||Parent Psychosocial|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.42
71721776|NCT01032603|142960311|SUPERIORITY|||||||0.68||||||Parent Function|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.68
71721777|NCT01032603|142960311|SUPERIORITY|||||||0.64||||||Parent Surgical|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.||||0.64
71721778|NCT01032603|142960312|SUPERIORITY||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.0|13.0||||||"The cumulative proportion of participants with re-operation by 3 years was obtained using the Kaplan-Meier (K-M) method.~A treatment-group difference and a corresponding 95% confidence interval were calculated.~Treatment-group differences were calculated as BLR minus RR."||13|-2|
71721779|NCT01032603|142960313|SUPERIORITY||Difference in percentage of participants|-15.0|||||TWO_SIDED|95.0|-30.0|-0.0003||||||All treatment-group differences were calculated as the BLRc group minus the R\&R group. A treatment-group difference and a corresponding 95% confidence interval were calculated.||-.0003|-30|
71721780|NCT01032603|142960314|SUPERIORITY||Difference in percentage of participants|12.0|||||TWO_SIDED|95.0|-1.0|25.0||||||The proportion of participants with suboptimal surgical outcome at 3 years was compared between treatment groups using Barnard's exact test, and an exact 95% CI on the treatment-group difference was calculated using Farrington-Manning scores.||25|-1|
71721781|NCT02168062|142960342|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||||||0.109
71721782|NCT02168062|142960344|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Systolic Blood Pressure measurement comparison||||0.85
71721783|NCT02168062|142960344|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Diastolic Blood Pressure measurement comparison||||0.10
71721784|NCT02168062|142960345|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Weight measurement comparison||||0.70
71887598|NCT05888103|143296151|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.6|0.76|||ANCOVA|||||0.76|0.60|<0.0001
71887599|NCT05888103|143296152|SUPERIORITY||LS Mean Difference|3.01||||0.5877|TWO_SIDED|95.0|-7.88|13.91|||ANCOVA|||||13.91|-7.88|0.5877
71721785|NCT02168062|142960346|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Percentage body fat measurement comparison||||0.11
71721786|NCT02168062|142960347|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Waist measurement comparison||||0.32
71721787|NCT02168062|142960348|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Hemoglobin A1C measurement comparison||||0.70
71721788|NCT02168062|142960349|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Insulin resistance score comparison||||0.46
71721789|NCT02168062|142960350|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Total Cholesterol measurement comparison||||0.44
71721790|NCT02168062|142960350|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Total low density lipid measurement comparison||||0.52
71721791|NCT02168062|142960350|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Total high density lipid measurement comparison||||0.40
71721792|NCT02168062|142960350|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Total triglyceride measurement comparison||||0.53
71721793|NCT02168062|142960351|OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Non-vigorous physical activity comparison||||0.38
71721794|NCT02168062|142960351|OTHER|||||||0.979|||||||Wilcoxon (Mann-Whitney)|||Moderate physical activity comparison||||0.979
71721795|NCT02168062|142960351|OTHER|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||Moderate-Vigorous physical activity comparison||||0.884
71721796|NCT02168062|142960351|OTHER|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Vigorous physical activity comparison||||0.678
71721797|NCT02168062|142960351|OTHER|||||||0.464|||||||Wilcoxon (Mann-Whitney)|||Total physical activity comparison||||0.464
71721798|NCT02168062|142960352|OTHER|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Average MVPA Minutes per Day Comparison||||0.838
71721799|NCT02168062|142960353|OTHER|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the lumbar spine comparison||||0.677
71721800|NCT02168062|142960353|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||Bone Density at the femoral neck comparison||||0.493
71721801|NCT02168062|142960353|OTHER|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||Bone Density of the total hip comparison||||0.807
71721802|NCT02168062|142960354|OTHER|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||Serum 25-(OH) vitamin D level comparison||||0.403
71721803|NCT02168062|142960355|OTHER|||||||0.385|||||||Wilcoxon (Mann-Whitney)|||||||.385
71721804|NCT02168062|142960356|OTHER|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Attention Function Index (AFI) Score Comparison||||.148
71721805|NCT02168062|142960357|OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||Mental Composite Score Comparison||||.077
71887600|NCT05888103|143296153|SUPERIORITY||LS Mean Difference|-7.96||||0.5019|TWO_SIDED|95.0|-31.17|15.26|||ANCOVA|||||15.26|-31.17|0.5019
71887601|NCT02324270|143296159|EQUIVALENCE|If the 90% CI for the ratio of mean changes between test and reference products was contained within the interval, \[0.80,1.25\], then the products were considered to be equivalent.|Ratio|1.01|||||TWO_SIDED|90.0|0.94|1.08||||||||1.08|0.94|
71887602|NCT02324270|143296160|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
71657092|NCT02944383|142831655|SUPERIORITY||Median Difference (Net)|-2.38||||0.548|TWO_SIDED|95.0|-11.82|6.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.86|-11.82|0.5480
71721806|NCT02168062|142960357|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||Physical Composite Score Comparison||||0.401
71657093|NCT02944383|142831656|SUPERIORITY|||||||0.1485||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.1485
71657094|NCT02944383|142831656|SUPERIORITY|||||||0.6008||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 2||||0.6008
71657095|NCT02944383|142831656|SUPERIORITY|||||||0.9409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9409
71657096|NCT02944383|142831656|SUPERIORITY|||||||0.9292||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 6||||0.9292
71657097|NCT02944383|142831656|SUPERIORITY|||||||0.8455||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8455
71721807|NCT02168062|142960358|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
71887603|NCT02324270|143296160|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71887604|NCT00680836|143296161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.26|TWO_SIDED|95.0|-1.0|0.3|||t-test, 2 sided|||||0.3|-1.0|0.26
71887605|NCT00680836|143296162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|0.0|0.5|||t-test, 2 sided|||||0.5|0.0|0.98
71887606|NCT00680836|143296163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.78
71657098|NCT02944383|142831656|SUPERIORITY|||||||0.5256||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5256
71657099|NCT02944383|142831656|SUPERIORITY|||||||0.9217||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9217
71657100|NCT02944383|142831656|SUPERIORITY|||||||0.7401||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7401
71657101|NCT02944383|142831656|SUPERIORITY|||||||0.9386||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9386
71657102|NCT02944383|142831656|SUPERIORITY|||||||0.6352||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6352
71721808|NCT02168062|142960359|OTHER|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.676
71721809|NCT02168062|142960360|OTHER|||||||0.183|||||||Wilcoxon (Mann-Whitney)|||||||0.183
71721810|NCT02168062|142960361|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Total Score Comparison||||0.66
71721811|NCT02168062|142960361|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Incontinence Score Comparison||||0.844
71721812|NCT02168062|142960361|OTHER|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Urinary Irriation Score Comparison||||0.175
71721813|NCT02168062|142960361|OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Bowel Function Score Comparison||||0.472
71721814|NCT02168062|142960361|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Sexual Function Score Comparison||||0.405
71721815|NCT02168062|142960361|OTHER|||||||0.749|||||||Wilcoxon (Mann-Whitney)|||EPIC-26 Hormonal Function Score Comparison||||0.749
71721816|NCT02168062|142960362|OTHER|||||||0.907|||||||Wilcoxon (Mann-Whitney)|||Fatigue Scale Score Comparison||||0.907
71721817|NCT02168062|142960362|OTHER|||||||0.792|||||||Wilcoxon (Mann-Whitney)|||Energy Scale Score Comparison||||0.792
71769323|NCT01879579|143039093|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71887607|NCT00680836|143296164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.64|TWO_SIDED|95.0|-0.2|0.2|||Chi-squared|||||0.2|-0.2|0.64
71887608|NCT00680836|143296165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.72|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||||0.5|-0.7|0.72
71887609|NCT00680836|143296166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||||0.6|-0.5|0.86
71887610|NCT03968419|143296195|OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-25.56|21.23||||||Difference in MPR rate||21.23|-25.56|
71887611|NCT00167245|143296211|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71887612|NCT00167245|143296212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||Generalized Estimating Equations|||||||0.45
71887613|NCT00167245|143296213|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4|TWO_SIDED|95.0|-2.1|5.2|||t-test, 2 sided|||||5.2|-2.1|0.4
71887614|NCT00804687|143296221|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0602||95.0|-0.258|0.006|||Linear mixed model|||||0.006|-0.258|0.0602
71657103|NCT02944383|142831657|SUPERIORITY|||||||0.0165||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0165
71657104|NCT02944383|142831657|SUPERIORITY|||||||0.3075||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3075
71657105|NCT02944383|142831657|SUPERIORITY|||||||0.1069||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1069
71657106|NCT02944383|142831657|SUPERIORITY|||||||0.6101||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6101
71657107|NCT02944383|142831657|SUPERIORITY||Median Difference (Net)|-12.04||||0.0351|TWO_SIDED|95.0|-23.79|-1.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.08|-23.79|0.0351
71657108|NCT02944383|142831657|SUPERIORITY||Median Difference (Net)|-3.15||||0.3746|TWO_SIDED|95.0|-9.86|4.25||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.25|-9.86|0.3746
71657109|NCT02944383|142831658|SUPERIORITY|||||||0.0133||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0133
71721818|NCT01606176|142960386|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.39||||0.332|TWO_SIDED|95.0|-1.18|0.4|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.40|-1.18|0.332
71769324|NCT01879579|143039094|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Interval-censoring survival analysis|||||||0.007
71769325|NCT01879579|143039095|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.99
71887615|NCT00804687|143296221|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.195|STANDARD_ERROR_OF_MEAN|0.067||0.0043||95.0|-0.328|-0.063|||Linear mixed model|||||-0.063|-0.328|0.0043
71887616|NCT00804687|143296221|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-0.066|STANDARD_ERROR_OF_MEAN|0.07||0.3513|TWO_SIDED|95.0|-0.206|0.075|||Linear mixed model|||||0.075|-0.206|0.3513
71887617|NCT00804687|143296222|SUPERIORITY_OR_OTHER||Least Squares Mean difference|8.604|STANDARD_ERROR_OF_MEAN|2.267||0.0003||95.0|4.104|13.104|||Linear mixed model|||||13.104|4.104|0.0003
71887618|NCT00804687|143296222|SUPERIORITY_OR_OTHER||Least Squares Mean difference|4.699|STANDARD_ERROR_OF_MEAN|2.289||0.0428||95.0|0.155|9.243|||Linear mixed model|||||9.243|0.155|0.0428
71887619|NCT00804687|143296222|SUPERIORITY_OR_OTHER||Least Squares Mean difference|-3.905|STANDARD_ERROR_OF_MEAN|2.277||0.0895|TWO_SIDED|95.0|-8.424|0.614|||Linear mixed model|||||0.614|-8.424|0.0895
71657110|NCT02944383|142831658|SUPERIORITY|||||||0.2044||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2044
71657111|NCT02944383|142831658|SUPERIORITY|||||||0.0855||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0855
71657112|NCT02944383|142831658|SUPERIORITY|||||||0.5114||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5114
71657113|NCT02944383|142831658|SUPERIORITY|||||||0.0289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0289
71721819|NCT01606176|142960387|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-29.55||||0.002|TWO_SIDED|95.0|-48.08|-11.02|||ANOVA|||The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.||-11.02|-48.08|0.002
71887620|NCT00445302|143296240|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|87.09|||||TWO_SIDED|90.0|63.59|119.26||||||||119.26|63.59|
71887621|NCT00445302|143296240|SUPERIORITY_OR_OTHER||Ratio of least squares means(%)|106.6||||||90.0|78.99|143.87||||||||143.87|78.99|
71887622|NCT00445302|143296240|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|106.76||||||90.0|79.11|144.08||||||||144.08|79.11|
71887623|NCT00445302|143296243|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|121.74||||||90.0|91.86|161.43||||||||161.43|91.86|
71887624|NCT00445302|143296243|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|151.44||||||90.0|115.78|198.09||||||||198.09|115.78|
71887625|NCT00445302|143296243|SUPERIORITY_OR_OTHER||Ratio of least squares means (%)|169.51||||||90.0|129.59|221.72||||||||221.72|129.59|
71887626|NCT03216382|143296295|SUPERIORITY|||||||0.93||||||The apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.93
71887627|NCT03216382|143296296|SUPERIORITY|||||||0.74||||||this value represents the interaction between condition and the intervention time period The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.74
71721820|NCT01606176|142960388|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.34||||0.052|TWO_SIDED|95.0|-0.68|0.0|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.00|-0.68|0.052
71721821|NCT01606176|142960389|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.79||||0.3|TWO_SIDED|95.0|-8.14|2.56|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||2.56|-8.14|0.300
71721822|NCT01606176|142960390|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.66||||0.233|TWO_SIDED|95.0|-4.42|1.1|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||1.10|-4.42|0.233
71721823|NCT01606176|142960391|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.28||||0.387|TWO_SIDED|95.0|-0.36|0.91|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.91|-0.36|0.387
71721824|NCT01606176|142960392|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.47||||1|TWO_SIDED|95.0|-21.56|18.51|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||18.51|-21.56|1.000
71721825|NCT01606176|142960393|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.86||||0.128|TWO_SIDED|95.0|-1.97|0.26|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"||0.26|-1.97|0.128
71721826|NCT01606176|142960394|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-31.77||||0.009|TWO_SIDED|95.0|-55.07|-8.47|||ANOVA|||The proportions were compared between treatment groups using ANOVA with treatment as a factor.||-8.47|-55.07|0.009
71721827|NCT01606176|142960395|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.184|TWO_SIDED|95.0|-0.8|0.16|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"||0.16|-0.80|0.184
71769326|NCT01879579|143039096|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.78
71769327|NCT01879579|143039097|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.04
71769328|NCT01879579|143039098|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.13
71887628|NCT03216382|143296296|SUPERIORITY|||||||0.44||||||this value represents the interaction between condition and the intervention time period (squared) The apriori threshold for significance was a = 0.05.|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on uncontrollability of worry||||.44
71721828|NCT01606176|142960396|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.18||||0.134|TWO_SIDED|95.0|-12.05|1.68|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"||1.68|-12.05|0.134
71721829|NCT01606176|142960397|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.77||||0.031|TWO_SIDED|95.0|-7.17|-0.36|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"||-0.36|-7.17|0.031
71721830|NCT01606176|142960398|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.04||||0.915|TWO_SIDED|95.0|-0.79|0.88|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"||0.88|-0.79|0.915
71721831|NCT01606176|142960399|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|3.95||||1|TWO_SIDED|95.0|-21.85|27.47|||Fisher Exact|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test."||27.47|-21.85|1.00
71721832|NCT02993822|142960405|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.324|TWO_SIDED|95.0|0.88|1.49|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.49|0.88|0.324
71769329|NCT01879579|143039103|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Generalized estimating equation modeling|||||||0.008
71887629|NCT03216382|143296297|SUPERIORITY|||||||0.17||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.17
71887630|NCT03216382|143296298|SUPERIORITY|||||||0.5||||||The apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time .|Mixed Models Analysis|||HLM piecewise analysis was used to examine linear change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.50
71887631|NCT03216382|143296298|SUPERIORITY|||||||0.02||||||The apriori threshold for significance was a= 0.05. The p value reflects the test of an interaction between condition and intervention period (days 7-14, squared).|Mixed Models Analysis|||HLM piecewise analysis was used to examine quadratic change from day 1-7 (visit 1 to visit 2) and change from day 7-14 (visit 2 to visit 3) on self-focused attention||||.02
71887632|NCT03216382|143296299|SUPERIORITY|||||||0.46||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.46
71887633|NCT03216382|143296300|SUPERIORITY|||||||0.53||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.53
71887634|NCT03216382|143296301|SUPERIORITY|||||||0.07||||||the apriori threshold for significance was a = 0.05. The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.07
71887635|NCT03216382|143296302|SUPERIORITY|||||||0.58||||||the apriori threshold for significance was 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.58
71721833|NCT02993822|142960405|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.332|TWO_SIDED|95.0|0.88|1.48|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.48|0.88|0.332
71887636|NCT03216382|143296303|SUPERIORITY|||||||0.86||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.86
71721834|NCT02993822|142960405|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.531|TWO_SIDED|95.0|0.71|1.2|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.20|0.71|0.531
71721835|NCT02993822|142960406|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.482|TWO_SIDED|95.0|0.75|1.15|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.15|0.75|0.482
71721836|NCT02993822|142960406|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.46|TWO_SIDED|95.0|0.75|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.75|0.460
71769330|NCT01879579|143039104|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.003
71887637|NCT03216382|143296304|SUPERIORITY|||||||0.39||||||the apriori threshold for significance was a = 0.05 The p value reflects the test of an interaction between condition and time.|ANOVA|||||||.39
71887638|NCT00927368|143296360|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-0.16|||<|0.001|TWO_SIDED|95.0|-0.61|0.29||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.29|-0.61|< 0.001
71887639|NCT00927368|143296360|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.16||||0.03|TWO_SIDED|95.0|-0.29|0.61||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.61|-0.29|0.03
71887640|NCT00927368|143296360|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.57|0.33||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.33|-0.57|< 0.001
71721837|NCT02993822|142960406|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.144|TWO_SIDED|95.0|0.69|1.06|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.06|0.69|0.144
71721838|NCT02993822|142960407|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.992|TWO_SIDED|95.0|0.78|1.27|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.27|0.78|0.992
71721839|NCT02993822|142960407|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.387|TWO_SIDED|95.0|0.71|1.14|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.14|0.71|0.387
71721840|NCT02993822|142960407|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.6|TWO_SIDED|95.0|0.74|1.19|||Mixed model repeated measures|||Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means \[adjusted means\] on the log scale, back transformed to the original scale).||1.19|0.74|0.600
71721841|NCT02993822|142960408|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.042|TWO_SIDED|95.0|0.0|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.0|0.042
71721842|NCT02993822|142960408|SUPERIORITY||Median Difference (Final Values)|1.1||||0.026|TWO_SIDED|95.0|0.1|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|0.1|0.026
71721843|NCT02993822|142960408|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.003|TWO_SIDED|95.0|0.5|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.5|0.003
71721844|NCT02993822|142960409|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.25|TWO_SIDED|95.0|-0.4|1.7|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.7|-0.4|0.250
71769331|NCT02927067|143039108|NON_INFERIORITY|Non-inferiority (NI) margin of primary efficacy endpoint was 7%. If lower limit of 95% confidence interval (CI) was greater than -7%, NI was assumed. Power calculation: Assuming 68% (maribavir), 60% (valganciclovir) participants achieve confirmed viremia clearance,494 participants (247 per group) would yield \>90% power to declare NI based on 2-group test of equivalence in proportions. Considering 10% dropout,550 participants (275 per group) were planned to be enrolled and randomized.|Difference in Percentage of Responders|-7.7|||||TWO_SIDED|95.0|-14.98|-0.36|||||Cochran-Mantel-Haenszel (CMH) weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for adjusted difference in percentage of responders (Maribavir-Valganciclovir), 95% CI, and p-value.|||-0.36|-14.98|
71887641|NCT00927368|143296360|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).|Mean Difference (Final Values)|0.12||||0.02|TWO_SIDED|95.0|-0.33|0.57||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.||0.57|-0.33|0.02
71721845|NCT02993822|142960409|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.325|TWO_SIDED|95.0|-0.5|1.5|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.5|-0.5|0.325
71721846|NCT02993822|142960409|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.029|TWO_SIDED|95.0|0.1|2.2|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.2|0.1|0.029
71721847|NCT02993822|142960410|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.038|TWO_SIDED|95.0|0.1|2.3|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.3|0.1|0.038
71721848|NCT02993822|142960410|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.118|TWO_SIDED|95.0|-0.2|2.0|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.0|-0.2|0.118
71721849|NCT02993822|142960410|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.025|TWO_SIDED|95.0|0.2|2.4|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.4|0.2|0.025
71721850|NCT02993822|142960411|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.9|-0.5|0.258
71721851|NCT02993822|142960411|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.243|TWO_SIDED|95.0|-0.5|1.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||1.8|-0.5|0.243
71721852|NCT02993822|142960411|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.009|TWO_SIDED|95.0|0.4|2.8|||Mixed model repeated measures|||"The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.~The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation."||2.8|0.4|0.009
71721853|NCT02993822|142960412|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.008|TWO_SIDED|95.0|-16.6|-2.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-2.5|-16.6|0.008
71721854|NCT02993822|142960412|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.198|TWO_SIDED|95.0|-11.4|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-11.4|0.198
71721855|NCT02993822|142960412|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.055|TWO_SIDED|95.0|-13.7|0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.1|-13.7|0.055
71721856|NCT02993822|142960413|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.026|TWO_SIDED|95.0|-16.3|-1.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.1|-16.3|0.026
71769332|NCT02927067|143039109|NON_INFERIORITY|The non-inferiority margin of the key secondary efficacy endpoint was 7%. If the lower limit of the 95% CI was greater than -7%, then noninferiority (NI) was assumed. Because the NI of the primary efficacy endpoint was not established, the NI hypothesis of the key secondary endpoint was not tested formally.|Difference in Percentage of Responders|4.4|||||TWO_SIDED|95.0|-3.91|12.76|||||CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|||12.76|-3.91|
71769333|NCT02927067|143039110|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||||16.30|-0.38|=0.061
71769334|NCT02927067|143039111|SUPERIORITY||Difference in Percentage of Responders|8.0|||=|0.061|TWO_SIDED|95.0|-0.38|16.3||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||16.30|-0.38|=0.061
71769335|NCT02927067|143039111|SUPERIORITY||Difference in Percentage of Responders|13.4|||=|0.001|TWO_SIDED|95.0|5.23|21.62||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||21.62|5.23|=0.001
71657114|NCT02944383|142831658|SUPERIORITY|||||||0.295||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.2950
71657115|NCT02944383|142831659|SUPERIORITY|||||||0.1992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1992
71657116|NCT02944383|142831659|SUPERIORITY|||||||0.9945||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9945
71657117|NCT02944383|142831659|SUPERIORITY|||||||0.5139||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5139
71657118|NCT02944383|142831659|SUPERIORITY|||||||0.8085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8085
71657119|NCT02944383|142831659|SUPERIORITY||Median Difference (Net)|-0.77||||0.7644|TWO_SIDED|95.0|-6.31|4.85||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.85|-6.31|0.7644
71657120|NCT02944383|142831659|SUPERIORITY||Mean Difference (Net)|1.33||||0.9499|TWO_SIDED|95.0|-4.34|6.66||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||6.66|-4.34|0.9499
71657121|NCT02944383|142831660|SUPERIORITY|||||||0.1521||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1521
71657122|NCT02944383|142831660|SUPERIORITY|||||||0.8982||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8982
71721857|NCT02993822|142960413|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.571|TWO_SIDED|95.0|-9.6|5.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.3|-9.6|0.571
71721858|NCT02993822|142960413|SUPERIORITY||Mean Difference (Final Values)|-7.7||||0.043|TWO_SIDED|95.0|-15.2|-0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.3|-15.2|0.043
71721859|NCT02993822|142960414|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.006|TWO_SIDED|95.0|-19.7|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-19.7|0.006
71721860|NCT02993822|142960414|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.435|TWO_SIDED|95.0|-11.1|4.8|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.8|-11.1|0.435
71721861|NCT02993822|142960414|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.022|TWO_SIDED|95.0|-17.4|-1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.4|-17.4|0.022
71769336|NCT02927067|143039111|SUPERIORITY||Difference in Percentage of Responders|13.8|||<|0.001|TWO_SIDED|95.0|5.8|21.87||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 16||21.87|5.80|<0.001
71657123|NCT02944383|142831660|SUPERIORITY|||||||0.6228||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6228
71657124|NCT02944383|142831660|SUPERIORITY|||||||0.9622||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.9622
71657125|NCT02944383|142831660|SUPERIORITY|||||||0.6643||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6643
71721862|NCT02993822|142960415|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.103|TWO_SIDED|95.0|-15.3|1.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||1.4|-15.3|0.103
71721863|NCT02993822|142960415|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.546|TWO_SIDED|95.0|-10.6|5.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||5.6|-10.6|0.546
71721864|NCT02993822|142960415|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.034|TWO_SIDED|95.0|-17.2|-0.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.7|-17.2|0.034
71721865|NCT02993822|142960416|SUPERIORITY||Mean Difference (Final Values)|-11.2||||0.004|TWO_SIDED|95.0|-18.8|-3.6|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.6|-18.8|0.004
71721866|NCT02993822|142960416|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.282|TWO_SIDED|95.0|-11.5|3.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.4|-11.5|0.282
71721867|NCT02993822|142960416|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.398|TWO_SIDED|95.0|-10.7|4.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.3|-10.7|0.398
71721868|NCT02993822|142960417|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.019|TWO_SIDED|95.0|-18.3|-1.7|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.7|-18.3|0.019
71721869|NCT02993822|142960417|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.17|TWO_SIDED|95.0|-13.7|2.4|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.4|-13.7|0.170
71721870|NCT02993822|142960417|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.384|TWO_SIDED|95.0|-11.7|4.5|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||4.5|-11.7|0.384
71721871|NCT02993822|142960418|SUPERIORITY||Mean Difference (Final Values)|-11.7||||0.006|TWO_SIDED|95.0|-20.0|-3.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-3.3|-20.0|0.006
71721872|NCT02993822|142960418|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.222|TWO_SIDED|95.0|-13.0|3.0|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||3.0|-13.0|0.222
71769337|NCT02927067|143039111|SUPERIORITY||Difference in Percentage of Responders|9.7|||=|0.014|TWO_SIDED|95.0|1.98|17.5||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||17.50|1.98|=0.014
71769338|NCT02927067|143039112|SUPERIORITY||Difference in Percentage of Responders|-7.3|||=|0.051|TWO_SIDED|95.0|-14.64|0.02||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 8||0.02|-14.64|=0.051
71769339|NCT02927067|143039112|SUPERIORITY||Difference in Percentage of Responders|2.2|||=|0.606|TWO_SIDED|95.0|-6.05|10.37||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 12||10.37|-6.05|=0.606
71721873|NCT02993822|142960418|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.058|TWO_SIDED|95.0|-16.0|0.3|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||0.3|-16.0|0.058
71721874|NCT02993822|142960419|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.027|TWO_SIDED|95.0|-18.9|-1.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-1.2|-18.9|0.027
71721875|NCT02993822|142960419|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.147|TWO_SIDED|95.0|-14.9|2.2|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||2.2|-14.9|0.147
71721876|NCT02993822|142960419|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.046|TWO_SIDED|95.0|-17.6|-0.1|||Mixed model repeated measures|||Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.||-0.1|-17.6|0.046
71721877|NCT02993822|142960420|SUPERIORITY||Mean Difference (Final Values)|-12.5|||<|0.001|TWO_SIDED|95.0|-19.5|-5.5|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-5.5|-19.5|<0.001
71721878|NCT02993822|142960420|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.114|TWO_SIDED|95.0|-12.4|1.3|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||1.3|-12.4|0.114
71721879|NCT02993822|142960420|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.056|TWO_SIDED|95.0|-13.7|0.2|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||0.2|-13.7|0.056
71721880|NCT02993822|142960421|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.027|TWO_SIDED|95.0|-16.8|-1.0|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.0|-16.8|0.027
71721881|NCT02993822|142960421|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.357|TWO_SIDED|95.0|-11.3|4.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||4.1|-11.3|0.357
71721882|NCT02993822|142960421|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.031|TWO_SIDED|95.0|-16.2|-0.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.8|-16.2|0.031
71721883|NCT02993822|142960422|SUPERIORITY||Mean Difference (Final Values)|-11.1||||0.008|TWO_SIDED|95.0|-19.2|-2.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-2.9|-19.2|0.008
71721884|NCT02993822|142960422|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.321|TWO_SIDED|95.0|-11.8|3.9|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||3.9|-11.8|0.321
71721885|NCT02993822|142960422|SUPERIORITY||Mean Difference (Final Values)|-8.1||||0.047|TWO_SIDED|95.0|-16.0|-0.1|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-0.1|-16.0|0.047
71721886|NCT02993822|142960423|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.018|TWO_SIDED|95.0|-18.4|-1.8|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-1.8|-18.4|0.018
71721887|NCT02993822|142960423|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.682|TWO_SIDED|95.0|-9.8|6.4|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||6.4|-9.8|0.682
71769340|NCT02927067|143039112|SUPERIORITY||Difference in Percentage of Responders|1.0|||=|0.809|TWO_SIDED|95.0|-7.27|9.31||The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.|Cochran-Mantel-Haenszel|||Week 20||9.31|-7.27|=0.809
71721888|NCT02993822|142960423|SUPERIORITY||Mean Difference (Final Values)|-11.8||||0.005|TWO_SIDED|95.0|-20.0|-3.6|||Mixed model repeated measures|||Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.||-3.6|-20.0|0.005
71721889|NCT02993822|142960424|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
71721890|NCT02993822|142960424|SUPERIORITY|||||||0.134|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.134
71721891|NCT02993822|142960424|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
71721892|NCT02993822|142960425|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.401
71887642|NCT00927368|143296360|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.72|0.16||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.||0.16|-0.72|< 0.001
71721893|NCT02993822|142960425|SUPERIORITY|||||||0.175|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.175
71769341|NCT01727700|143039134|SUPERIORITY_OR_OTHER||Treatment difference|-6.26||||0.002|TWO_SIDED|95.0|-10.18|-2.34||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation \[SD\] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-2.34|-10.18|0.0020
71829753|NCT03622593|143163796|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in adjusted means for the faricimab 6 mg PTI and the active comparator (aflibercept 2 mg Q8W) arms was greater than -4 letters, then faricimab 6 mg PTI was considered non-inferior to aflibercept 2 mg Q8W. Non-inferiority was tested one-sided at a significance level of α = 0.0248.|Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|97.5|-1.1|2.1|||||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|
71721894|NCT02993822|142960425|SUPERIORITY|||||||0.126|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.126
71721895|NCT02993822|142960426|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.002
71721896|NCT02993822|142960426|SUPERIORITY|||||||0.144|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.144
71721897|NCT02993822|142960426|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
71721898|NCT02993822|142960427|SUPERIORITY|||||||0.158|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.158
71721899|NCT02993822|142960427|SUPERIORITY|||||||0.597|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.597
71721900|NCT02993822|142960427|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.124
71721901|NCT02993822|142960428|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.01
71721902|NCT02993822|142960428|SUPERIORITY|||||||0.049|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.049
71721903|NCT02993822|142960428|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.001
71721904|NCT02993822|142960429|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.309
71721905|NCT02993822|142960429|SUPERIORITY|||||||0.387|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.387
71721906|NCT02993822|142960429|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.025
71721907|NCT02993822|142960430|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.003
71829754|NCT03622593|143163796|SUPERIORITY||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1718|TWO_SIDED|97.5|-0.7|3.0||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||3.0|-0.7|0.1718
71829755|NCT03622593|143163796|SUPERIORITY||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4602|TWO_SIDED|97.5|-1.2|2.4||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||2.4|-1.2|0.4602
71829756|NCT03622593|143163796|SUPERIORITY||Adjusted mean difference|1.5|STANDARD_ERROR_OF_MEAN|0.73||0.0361|TWO_SIDED|97.5|-0.1|3.2||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||3.2|-0.1|0.0361
71829757|NCT03622593|143163796|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.73||0.493|TWO_SIDED|97.5|-1.1|2.1||Tested at an overall significance level of α = 0.0248.|Mixed Model for Repeated Measures||The difference in adjusted means was calculated as Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.|Three hypotheses were tested in order for each faricimab arm (Q8W or PTI) separately against the aflibercept arm using a graph-based testing procedure. The analysis presented here is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||2.1|-1.1|0.4930
71829758|NCT03622593|143163797|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab Q8W and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab Q8W was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-2.6|||||TWO_SIDED|97.5|-12.6|7.4||||||This analysis is for the non-inferiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|
71829759|NCT03622593|143163797|NON_INFERIORITY|If the lower bound of the two-sided 97.52% confidence interval for the difference in CMH weighted percentages of participants for the faricimab PTI and the active comparator (aflibercept Q8W) arms was greater than -10%, then faricimab PTI was considered non-inferior to aflibercept.|Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|97.5|-13.4|6.3||||||This analysis is for the non-inferiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|
71829760|NCT03622593|143163797|SUPERIORITY||Difference in CMH Weighted Percentage|-5.4||||0.3009|TWO_SIDED|97.5|-16.9|6.1||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||6.1|-16.9|0.3009
71657126|NCT02944383|142831660|SUPERIORITY|||||||0.9071||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9071
71657127|NCT02944383|142831661|SUPERIORITY|||||||0.5647||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5647
71657128|NCT02944383|142831661|SUPERIORITY|||||||0.1073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1073
71657129|NCT02944383|142831661|SUPERIORITY|||||||0.3858||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3858
71657130|NCT02944383|142831661|SUPERIORITY|||||||0.0916||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0916
71657131|NCT02944383|142831661|SUPERIORITY||Median Difference (Net)|0.0||||0.9473|TWO_SIDED|95.0|-5.56|5.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.26|-5.56|0.9473
71657132|NCT02944383|142831661|SUPERIORITY||Median Difference (Net)|4.54||||0.0911|TWO_SIDED|95.0|-1.83|9.95||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||9.95|-1.83|0.0911
71657133|NCT02944383|142831662|SUPERIORITY|||||||0.4623||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4623
71657134|NCT02944383|142831662|SUPERIORITY|||||||0.1678||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1678
71657135|NCT02944383|142831662|SUPERIORITY|||||||0.439||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4390
71657136|NCT02944383|142831662|SUPERIORITY|||||||0.129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1290
71657137|NCT02944383|142831662|SUPERIORITY|||||||0.9627||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9627
71657138|NCT02944383|142831662|SUPERIORITY|||||||0.0911||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0911
71721908|NCT02993822|142960430|SUPERIORITY|||||||0.152|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.152
71721909|NCT02993822|142960430|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.004
71721910|NCT02993822|142960431|SUPERIORITY|||||||0.1|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.100
71657139|NCT02944383|142831663|SUPERIORITY|||||||0.2882||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2882
71657140|NCT02944383|142831663|SUPERIORITY|||||||0.4474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4474
71657141|NCT02944383|142831663|SUPERIORITY|||||||0.7875||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7875
71657142|NCT02944383|142831663|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0600
71721911|NCT02993822|142960431|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.557
71721912|NCT02993822|142960431|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|||"The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (worse, about the same and better). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ)."||||0.054
71721913|NCT01732510|142960434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82||||0.015|TWO_SIDED|95.0|-16.87|-2.77|||Constrained longitudinal data analysis|||The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.||-2.77|-16.87|0.015
71721914|NCT00313144|142960454|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
71721915|NCT00313144|142960456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Paired t-test|||||||0.009
71721916|NCT00313144|142960457|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Paired t-test|||||||0.005
71721917|NCT00313144|142960459|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||Paired t-test|||||||0.006
71721918|NCT00313144|142960460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Paired t-test|||||||0.044
71769342|NCT01727700|143039134|SUPERIORITY_OR_OTHER||Treatment difference|-9.85|||<|0.0001|TWO_SIDED|95.0|-13.84|-5.86||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.||-5.86|-13.84|<0.0001
71721919|NCT00313144|142960461|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||Paired t-test|||||||0.046
71721920|NCT01939977|142960478|SUPERIORITY|||||||0.0083|||||||Chi-squared|||"Taking per protocol population, the percentage of patients with iPTH\> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol"||||0.0083
71721921|NCT01262560|142960503|SUPERIORITY_OR_OTHER|||||||0.92||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%).||Null hypothesis: Manuka honey in liquid form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.92
71721922|NCT01262560|142960503|SUPERIORITY_OR_OTHER|||||||0.93||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%)||Null hypothesis: Manuka honey in lozenge form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect \>= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).||||0.93
71721923|NCT01262560|142960504|SUPERIORITY_OR_OTHER|||||||0.87|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.87
71721924|NCT01262560|142960504|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.46
71721925|NCT01262560|142960504|SUPERIORITY|||||||0.0023|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0023
71721926|NCT01262560|142960504|SUPERIORITY|||||||0.0025|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0025
71721927|NCT01262560|142960504|SUPERIORITY||||||<|0.0001||||||Each explanatory variable is reported separately.|Mixed Models Analysis|||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
71721928|NCT01262560|142960505|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.70
71721929|NCT01262560|142960505|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.71
71721930|NCT01262560|142960505|SUPERIORITY|||||||0.0002|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.0002
71721931|NCT01262560|142960505|SUPERIORITY|||||||0.0051|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0051
71721932|NCT01262560|142960505|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||<0.0001
71721933|NCT01262560|142960506|SUPERIORITY_OR_OTHER|||||||0.086|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.086
71721934|NCT01262560|142960506|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.20
71721935|NCT01262560|142960506|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.44
71769343|NCT01727700|143039135|SUPERIORITY_OR_OTHER||Treatment difference|-1.03||||0.0001|TWO_SIDED|95.0|-1.54|-0.52||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.52|-1.54|0.0001
71769344|NCT01727700|143039135|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.0002|TWO_SIDED|95.0|-1.54|-0.49||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||||-0.49|-1.54|0.0002
71721936|NCT01262560|142960506|SUPERIORITY|||||||0.0066|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||0.0066
71721937|NCT01262560|142960506|SUPERIORITY|||||||0.36|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.36
71769345|NCT01727700|143039136|SUPERIORITY_OR_OTHER||Treatment difference|-13.26||||0.0017|TWO_SIDED|95.0|-21.43|-5.08||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-5.08|-21.43|0.0017
71769346|NCT01727700|143039136|SUPERIORITY_OR_OTHER||Treatment difference|-19.37|||<|0.0001|TWO_SIDED|95.0|-27.7|-11.04||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-11.04|-27.70|<0.0001
71721938|NCT01262560|142960506|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."||||0.94
71721939|NCT01262560|142960506|SUPERIORITY_OR_OTHER|||||||0.58|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."||||0.58
71721940|NCT01262560|142960506|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."||||0.28
71721941|NCT01262560|142960506|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each exploratory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."||||<0.0001
71721942|NCT01262560|142960506|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60\>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."||||0.28
71721943|NCT01262560|142960507|SUPERIORITY_OR_OTHER|||||||0.06||||||Significance level = 0.05|Fisher Exact|||||||0.06
71721944|NCT01262560|142960507|SUPERIORITY_OR_OTHER|||||||0.31||||||Significance level = 0.05|Fisher Exact|||||||0.31
71721945|NCT01262560|142960508|SUPERIORITY_OR_OTHER|||||||0.53||||||significance level = 0.05|t-test, 2 sided|||||||0.53
71769347|NCT01727700|143039137|SUPERIORITY_OR_OTHER||Treatment difference|-0.8||||0.001|TWO_SIDED|95.0|-1.27|-0.33||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.33|-1.27|0.0010
71721946|NCT01262560|142960508|SUPERIORITY_OR_OTHER|||||||0.88||||||significance level = 0.05|t-test, 2 sided|||||||0.88
71721947|NCT01262560|142960509|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
71769348|NCT01727700|143039137|SUPERIORITY_OR_OTHER||MMRM|-0.92||||0.0002|TWO_SIDED|95.0|-1.41|-0.44||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis|||||-0.44|-1.41|0.0002
71721948|NCT01262560|142960509|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71721949|NCT01262560|142960512|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.39
71721950|NCT01262560|142960512|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.||||0.69
71721951|NCT00673231|142960531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0726|<|0.0001|TWO_SIDED|95.0|-0.59|-0.31||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.31|-0.59|<0.0001
71721952|NCT00673231|142960531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.0718|<|0.0001|TWO_SIDED|95.0|-0.66|-0.38||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.38|-0.66|<0.0001
71657143|NCT02944383|142831663|SUPERIORITY||Median Difference (Net)|0.0||||0.9832|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.9832
71657144|NCT02944383|142831663|SUPERIORITY||Median Difference (Net)|0.0||||0.1352|TWO_SIDED|95.0|0.0|0.0||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.00|0.00|0.1352
71657145|NCT02944383|142831664|SUPERIORITY|||||||0.2857||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|ranked ANCOVA|||Week 10||||0.2857
71657146|NCT02944383|142831664|SUPERIORITY|||||||0.4486||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4486
71657147|NCT02944383|142831664|SUPERIORITY|||||||0.764||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7640
71657148|NCT02944383|142831664|SUPERIORITY|||||||0.056||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0560
71657149|NCT02944383|142831664|SUPERIORITY|||||||0.9954||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.9954
71657150|NCT02944383|142831664|SUPERIORITY|||||||0.1298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1298
71657151|NCT02944383|142831665|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.0161
71657152|NCT02944383|142831665|SUPERIORITY|||||||0.1806||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 10||||0.1806
71657153|NCT02944383|142831665|SUPERIORITY|||||||0.2657||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.2657
71657154|NCT02944383|142831665|SUPERIORITY|||||||0.5996||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA|||Week 12||||0.5996
71657155|NCT02944383|142831665|SUPERIORITY||Median Difference (Net)|-11.39||||0.027|TWO_SIDED|95.0|-28.81|2.08||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.08|-28.81|0.0270
71657156|NCT02944383|142831665|SUPERIORITY||Median Difference (Net)|-0.92||||0.5263|TWO_SIDED|95.0|-16.88|15.5||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||15.50|-16.88|0.5263
71657157|NCT02944383|142831666|SUPERIORITY|||||||0.0345||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0345
71657158|NCT02944383|142831666|SUPERIORITY|||||||0.2709||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2709
71657159|NCT02944383|142831666|SUPERIORITY|||||||0.3255||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3255
71721953|NCT00673231|142960531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.0733|<|0.0001|TWO_SIDED|95.0|-0.74|-0.45||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.45|-0.74|<0.0001
71657160|NCT02944383|142831666|SUPERIORITY|||||||0.7391||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7391
71721954|NCT00673231|142960532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.256||0.0001|TWO_SIDED|95.0|-1.5|-0.49||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-1.50|0.0001
71721955|NCT00673231|142960532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2523|<|0.0001|TWO_SIDED|95.0|-1.5|-0.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.50|-1.50|<0.0001
71721956|NCT00673231|142960532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.2578|<|0.0001|TWO_SIDED|95.0|-2.19|-1.18||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-1.18|-2.19|<0.0001
71721957|NCT00673231|142960533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|STANDARD_ERROR_OF_MEAN|1.3195|<|0.0001|TWO_SIDED|95.0|-9.46|-4.28||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-4.28|-9.46|<0.0001
71721958|NCT00673231|142960533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.3045|<|0.0001|TWO_SIDED|95.0|-8.25|-3.13||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.13|-8.25|<0.0001
71721959|NCT00673231|142960533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.3286|<|0.0001|TWO_SIDED|95.0|-8.84|-3.63||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-3.63|-8.84|<0.0001
71721960|NCT00673231|142960534|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|3.536||0.0427|TWO_SIDED|95.0|0.2|14.1||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||14.1|0.2|0.0427
71721961|NCT00673231|142960534|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|3.434||0.0903|TWO_SIDED|95.0|-0.9|12.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.5|-0.9|0.0903
71721962|NCT00673231|142960534|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.7|STANDARD_ERROR_OF_MEAN|3.634||0.0166|TWO_SIDED|95.0|1.6|15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||15.8|1.6|0.0166
71721963|NCT00673231|142960535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|4.684||0.0008|TWO_SIDED|95.0|-25.0|-6.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-6.6|-25.0|0.0008
71721964|NCT00673231|142960535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|4.616|||TWO_SIDED|95.0|-31.2|-13.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.1|-31.2|
71721965|NCT00673231|142960535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|STANDARD_ERROR_OF_MEAN|4.718|<|0.0001|TWO_SIDED|95.0|-34.3|-15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.8|-34.3|<0.0001
71721966|NCT03594747|142960537|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.0001|TWO_SIDED|95.0|0.37|0.74|||One-sided stratified log-rank test|||||0.74|0.37|0.0001
71769349|NCT01727700|143039138|SUPERIORITY_OR_OTHER||Response ratio|1.36||||0.0835|TWO_SIDED|95.0|0.98|1.88||P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||1.88|0.98|0.0835
71887643|NCT00927368|143296360|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.28||||0.11|TWO_SIDED|95.0|-0.16|0.72||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.||0.72|-0.16|0.11
71887644|NCT00927368|143296361|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|5.0||||0.04|TWO_SIDED|95.0|-17.0|34.0||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||34|-17|0.04
71887645|NCT00927368|143296361|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-5.0||||0.002|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.002
71887646|NCT00927368|143296361|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|3.0||||0.03|TWO_SIDED|95.0|-25.0|21.0||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||21|-25|0.03
71887647|NCT00927368|143296361|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-3.0||||0.005|TWO_SIDED|95.0|-24.0|23.0||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.||23|-24|0.005
71657161|NCT02944383|142831666|SUPERIORITY|||||||0.0808||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0808
71657162|NCT02944383|142831666|SUPERIORITY|||||||0.6509||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6509
71657163|NCT02944383|142831667|SUPERIORITY|||||||0.0004||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0004
71721967|NCT03594747|142960537|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.67|||One-sided stratified log-rank test|||||0.67|0.33|<0.0001
71721968|NCT03594747|142960538|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.32|0.61||||||||0.61|0.32|
71887648|NCT00927368|143296361|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-2.0||||0.006|TWO_SIDED|95.0|-22.0|25.0||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.||25|-22|0.006
71657164|NCT02944383|142831667|SUPERIORITY|||||||0.0412||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0412
71657165|NCT02944383|142831667|SUPERIORITY|||||||0.1937||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1937
71721969|NCT03594747|142960538|SUPERIORITY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.3|0.59||||||||0.59|0.30|
71721970|NCT00943098|142960629|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.71||||0.813|TWO_SIDED|95.0|-6.62|5.2|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.20|-6.62|0.813
71769350|NCT01727700|143039138|SUPERIORITY_OR_OTHER||Response ratio|1.61||||0.0014|TWO_SIDED|95.0|1.2|2.16||P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio \> 1 favors aripiprazole.||||2.16|1.20|0.0014
71769351|NCT01727700|143039139|SUPERIORITY_OR_OTHER||Discontinuation ratio|1.16||||0.9187|TWO_SIDED|95.0|0.19|7.05||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||7.05|0.19|0.9187
71769352|NCT01727700|143039139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.9576||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.9576
71769353|NCT01727700|143039139|SUPERIORITY_OR_OTHER||Discontinuation ratio|4.06||||0.0132|TWO_SIDED|95.0|1.1|14.95||Discontinuation ratio \< 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|||||14.95|1.10|0.0132
71721971|NCT00943098|142960642|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.51||||0.862|TWO_SIDED|95.0|-6.23|5.22|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.||5.22|-6.23|0.862
71721972|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-3.62|-1.22||||||Day 8 Cohort A: TIP, Pooled PBO||-1.22|-3.62|
71721973|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.3|-0.98||||||Day 8 Cohort A: TIP/PBO, Pooled PBO||-0.98|-3.30|
71721974|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-3.2|-0.68||||||Day 8 Cohort B: TIP, Pooled PBO||-0.68|-3.20|
71721975|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.3|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-4.38|-2.15||||||Day 8 Cohort B: TIP/PBO, Pooled PBO|LS Mean Diff (SE) vs pooled placebo|-2.15|-4.38|
71721976|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.0|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-5.06|-2.88||||||Day 8 Cohort C: TIP, Pooled PBO||-2.88|-5.06|
71721977|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.4|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.57|-2.14||||||Day 8 Cohort C: TIP/PBO, Pooled PBO||-2.14|-4.57|
71721978|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-3.66|-1.89||||||Day 8: Pooled TIP, Pooled PBO||-1.89|-3.66|
71721979|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-3.79|-2.05||||||Day 8: Pooled TIP/PBO, Pooled PBO||-2.05|-3.79|
71721980|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-4.28|-1.31||||||Day 29 Cohort A: TIP, Pooled PBO||-1.31|-4.28|
71721981|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-4.03|-0.67||||||Day 29 Cohort A: TIP/PBO, Pooled PBO||-0.67|-4.03|
71721982|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-4.04|-0.52||||||Day 29 Cohort B: TIP, Pooled PBO||-0.52|-4.04|
71769354|NCT01727700|143039139|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.51||||0.0278||||||Hazard ratio \< 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox|||||||0.0278
71769355|NCT02484859|143039149|SUPERIORITY||||||>|0.69|||||||Wilcoxon (Mann-Whitney)|||Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.||||>0.69
71769356|NCT02484859|143039150|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769357|NCT02484859|143039151|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||0.052
71769358|NCT02484859|143039152|SUPERIORITY|||||||0.05|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.||||0.05
71769359|NCT02484859|143039152|SUPERIORITY|||||||0.55|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.||||0.55
71721983|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-5.16|-1.85||||||Day 29 Cohort B: TIP/PBO, Pooled PBO||-1.85|-5.16|
71721984|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-4.6|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-6.13|-3.09||||||Day 29 Cohort C: TIP, Pooled PBO||-3.09|-6.13|
71721985|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-4.68|-1.52||||||Day 29 Cohort C: TIP/PBO, Pooled PBO||-1.52|-4.68|
71721986|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.2|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.43|-2.02||||||Day 29: Pooled TIP, Pooled PBO||-2.02|-4.43|
71721987|NCT02712983|142960658|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-4.19|-1.78||||||Day 29: Pooled TIP/PBO, Pooled PBO||-1.78|-4.19|
71721988|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-3.82|-0.36||||||Day 57 Cohort A: TIP, Pooled PBO||-0.36|-3.82|
71769360|NCT02484859|143039153|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71769361|NCT03386253|143039155|SUPERIORITY|||||||0.77||||||Group x time p value|ANOVA|||||||0.77
71769362|NCT01949337|143039156|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.33|TWO_SIDED|95.0|0.8|1.08|||Log Rank|||||1.08|0.80|0.33
71657166|NCT02944383|142831667|SUPERIORITY|||||||0.474||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4740
71657167|NCT02944383|142831667|SUPERIORITY||Median Difference (Net)|-14.32||||0.0116|TWO_SIDED|95.0|-34.13|3.89||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||3.89|-34.13|0.0116
71657168|NCT02944383|142831667|SUPERIORITY||Median Difference (Net)|-3.66||||0.1109|TWO_SIDED|95.0|-23.85|14.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.26|-23.85|0.1109
71829761|NCT03622593|143163797|SUPERIORITY||Difference in CMH Weighted Percentage|-6.9||||0.1735|TWO_SIDED|97.5|-18.3|4.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||4.4|-18.3|0.1735
71657169|NCT02944383|142831668|SUPERIORITY|||||||0.0002||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0002
71657170|NCT02944383|142831668|SUPERIORITY|||||||0.0161||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0161
71657171|NCT02944383|142831668|SUPERIORITY|||||||0.3043||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3043
71657172|NCT02944383|142831668|SUPERIORITY|||||||0.4639||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4639
71657173|NCT02944383|142831668|SUPERIORITY|||||||0.021||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0210
71657174|NCT02944383|142831668|SUPERIORITY|||||||0.0992||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0992
71657175|NCT02944383|142831669|SUPERIORITY|||||||0.1512||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1512
71657176|NCT02944383|142831669|SUPERIORITY|||||||0.84||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8400
71657177|NCT02944383|142831669|SUPERIORITY|||||||0.0244||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0244
71657178|NCT02944383|142831669|SUPERIORITY|||||||0.1803||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1803
71657179|NCT02944383|142831669|SUPERIORITY||Median Difference (Net)|-24.41||||0.0307|TWO_SIDED|95.0|-42.73|-9.94||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-9.94|-42.73|0.0307
71657180|NCT02944383|142831669|SUPERIORITY||Median Difference (Net)|-8.73||||0.5326|TWO_SIDED|95.0|-23.33|7.68||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.68|-23.33|0.5326
71657181|NCT02944383|142831670|SUPERIORITY|||||||0.1705||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1705
71657182|NCT02944383|142831670|SUPERIORITY|||||||0.9193||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9193
71657183|NCT02944383|142831670|SUPERIORITY|||||||0.0224||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0224
71829762|NCT03622593|143163797|SUPERIORITY||Difference in CMH Weighted Percentage|-2.6||||0.5757|TWO_SIDED|97.5|-12.6|7.4||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm A: Faricimab 6 mg Q8W compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||7.4|-12.6|0.5757
71721989|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-2.21|1.29||||||Day 57 Cohort A: TIP/PBO, Pooled PBO||1.29|-2.21|
71887649|NCT00927368|143296361|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|2.0||||0.02|TWO_SIDED|95.0|-20.0|29.0||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.||29|-20|0.02
71887650|NCT00927368|143296362|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||Stimulating needle versus stimulating catheter.||||0.11
71721990|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.87|0.08||||||Day 57 Cohort B: TIP, Pooled PBO||0.08|-3.87|
71721991|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-3.34|0.16||||||Day 57 Cohort B: TIP/PBO, Pooled PBO||0.16|-3.34|
71769363|NCT02446743|143039175|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine Group Difference|77.0|||||TWO_SIDED|95.0|68.1|84.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||84.1|68.1|
71769364|NCT02446743|143039175|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|60.0|||||TWO_SIDED|95.0|49.9|69.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||69.2|49.9|
71769365|NCT02446743|143039175|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.5|73.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||73.5|60.5|
71769366|NCT02446743|143039175|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|5.3|14.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.8|5.3|
71769367|NCT02446743|143039175|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10 vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|14.0|||||TWO_SIDED|95.0|4.9|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|4.9|
71769368|NCT02446743|143039175|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.3|15.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||15.9|4.3|
71769369|NCT02446743|143039176|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|25.0|||||TWO_SIDED|95.0|18.2|31.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||31.4|18.2|
71769370|NCT02446743|143039176|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[(Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine groups difference|22.0|||||TWO_SIDED|95.0|13.2|30.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||30.1|13.2|
71769371|NCT02446743|143039176|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|20.0|39.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||39.6|20.0|
71769372|NCT02446743|143039176|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.4|11.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.9|-3.4|
71769373|NCT02446743|143039176|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1(V72\_41)\]|vaccine group differences|12.0|||||TWO_SIDED|95.0|0.33|24.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.2|0.33|
71769374|NCT02446743|143039176|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1(V72P10)\]|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-10.0|9.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.5|-10.0|
71887651|NCT00927368|143296362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.0||||0.01|TWO_SIDED|95.0|6.0|75.0|||ANOVA|||Stimulating needle versus ultrasound guidance alone||75|6|0.01
71721992|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.9|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-5.5|-2.22||||||Day 57 Cohort C: TIP, Pooled PBO||-2.22|-5.50|
71721993|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.26|0.41||||||Day 57 Cohort C: TIP/PBO, Pooled PBO||0.41|-3.26|
71721994|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-3.98|-1.25||||||Day 57: Pooled TIP, Pooled PBO||-1.25|-3.98|
71721995|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.5|0.19||||||Day 57: Pooled TIP/PBO, Pooled PBO||0.19|-2.50|
71721996|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-4.0|-0.38||||||Day 85 Cohort A: TIP, Pooled PBO||-0.38|-4.00|
71721997|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.81|0.13||||||Day 85 Cohort A: TIP/PBO, Pooled PBO||0.13|-3.81|
71721998|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-4.96|-0.53||||||Day 85 Cohort B: TIP, Pooled PBO||-0.53|-4.96|
71721999|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.6|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-5.44|-1.73||||||Day 85 Cohort B: TIP/PBO, Pooled PBO||-1.73|-5.44|
71722000|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-4.9|-1.07||||||Day 85 Cohort C: TIP, Pooled PBO||-1.07|-4.90|
71657184|NCT02944383|142831670|SUPERIORITY|||||||0.2387||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2387
71722001|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.66|-0.53||||||Day 85 Cohort C: TIP/PBO, Pooled PBO||-0.53|-4.66|
71722002|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-4.11|-1.17||||||Day 85: Pooled TIP, Pooled PBO||-1.17|-4.11|
71722003|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-4.12|-1.23||||||Day 85: Pooled TIP/PBO, Pooled PBO||-1.23|-4.12|
71722004|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-4.55|-1.08||||||Day 113 Cohort A: TIP, Pooled PBO||-1.08|-4.55|
71887652|NCT00927368|143296362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.0|||<|0.001|TWO_SIDED|95.0|31.0|102.0|||ANOVA|||Stimulating catheter versus ultrasound guidance alone||102|31|< 0.001
71722005|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-1.61|1.71||||||Day 113 Cohort A: TIP/PBO, Pooled PBO||1.71|-1.61|
71722006|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.6|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-4.93|-0.29||||||Day 113 Cohort B: TIP, Pooled PBO||-0.29|-4.93|
71722007|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-3.62|-0.25||||||Day 113 Cohort B: TIP/PBO, Pooled PBO||-0.25|-3.62|
71722008|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-3.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-4.94|-1.3||||||Day 113 Cohort C: TIP, Pooled PBO||-1.30|-4.94|
71722009|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-4.37|-0.43||||||Day 113 Cohort C: TIP/PBO, Pooled PBO||-0.43|-4.37|
71722010|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.24|-1.45||||||Day 113: Pooled TIP, Pooled PBO||-1.45|-4.24|
71722011|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-2.73|-0.13||||||Day 113: Pooled TIP/PBO, Pooled PBO||-0.13|-2.73|
71722012|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.64|-0.73||||||EoT Cohort A: TIP, Pooled PBO||-0.73|-3.64|
71722013|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.61|1.43||||||EoT Cohort A: TIP/PBO, Pooled PBO||1.43|-1.61|
71722014|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.81|0.25||||||EoT Cohort B: TIP, Pooled PBO||0.25|-2.81|
71722015|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.14|-0.22||||||EoT Cohort B: TIP/PBO, Pooled PBO||-0.22|-3.14|
71722016|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.4|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.89|-0.98||||||EoT Cohort C: TIP, Pooled PBO||-0.98|-3.89|
71722017|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-3.12|-0.22||||||EoT Cohort C: TIP/PBO, Pooled PBO||-0.22|-3.12|
71722018|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.0|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.08|-0.85||||||EoT: Pooled TIP, Pooled PBO||-0.85|-3.08|
71722019|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.25|-0.04||||||EoT: Pooled TIP/PBO, Pooled PBO||-0.04|-2.25|
71722020|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.8|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-2.63|0.99||||||Day 141 Cohort A: TIP, Pooled PBO||0.99|-2.63|
71722021|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|0.1|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-1.83|1.98||||||Day 141 Cohort A: TIP/PBO, Pooled PBO||1.98|-1.83|
71722022|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|0.2|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-2.03|2.41||||||Day 141 Cohort B: TIP, Pooled PBO||2.41|-2.03|
71722023|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-3.68|-0.01||||||Day 141 Cohort B: TIP/PBO, Pooled PBO||-0.01|-3.68|
71722024|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.9|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.78|1.07||||||Day 141 Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||1.07|-2.78|
71722025|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.2|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-3.36|0.89||||||Day 141 Cohort C: TIP/PBO, Pooled PBO||0.89|-3.36|
71722026|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.97|0.98||||||Day 141: Pooled TIP, Pooled PBO||0.98|-1.97|
71887653|NCT00927368|143296363|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|14.0|||||TWO_SIDED||||||||Incremental cost (additional cost of stimulating needle compared to ultrasound alone).|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
71887654|NCT00927368|143296363|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|36.0|||||TWO_SIDED||||||||We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
71887655|NCT00927368|143296363|SUPERIORITY_OR_OTHER||incremental cost, measured in dollars|50.0|||||TWO_SIDED||||||||We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.||||
71887656|NCT03072160|143296392|OTHER|||||||0.926||||||CD4|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.926
71887657|NCT03072160|143296392|OTHER|||||||0.445||||||CD8|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.445
71887658|NCT03072160|143296392|OTHER|||||||0.21||||||Tregs|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.210
71887659|NCT03072160|143296392|OTHER|||||||0.78||||||Natural Killer (NK) cells|Wilcoxon signed-rank test||||A change is defined as being statistically significant (p\>0.05).|||0.780
71887660|NCT04276207|143296403|SUPERIORITY||Mean Difference (Final Values)|-0.377||||0.145|TWO_SIDED|95.0|-0.896|0.142|||Mixed Models Analysis|||||0.142|-0.896|0.1450
71887661|NCT04276207|143296404|SUPERIORITY||Mean Difference (Final Values)|-0.262||||0.001|TWO_SIDED|95.0|-0.406|-0.117|||Mixed Models Analysis|||||-0.117|-0.406|0.0010
71722027|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.45|0.45||||||Day 141: Pooled TIP/PBO, Pooled PBO||0.45|-2.45|
71887662|NCT04276207|143296405|SUPERIORITY||Mean Difference (Final Values)|-12.61||||0.0173|TWO_SIDED|95.0|-22.73|-2.49|||Mixed Models Analysis|||Day 1||-2.49|-22.73|0.0173
71722028|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.3|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.24|0.61||||||Day 169 Cohort A: TIP, Pooled PBO||0.61|-3.24|
71722029|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-3.05|0.91||||||Day 169 Cohort A: TIP/PBO, Pooled PBO||0.91|-3.05|
71887663|NCT04276207|143296405|SUPERIORITY||Mean Difference (Final Values)|-5.75||||0.0243|TWO_SIDED|95.0|-10.69|0.81|||Mixed Models Analysis|||Day 2||0.81|-10.69|0.0243
71722030|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.6|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-2.73|1.62||||||Day 169 Cohort B: TIP, Pooled PBO||1.62|-2.73|
71722031|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-2.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.22|-0.08||||||Day 169 Cohort B: TIP/PBO, Pooled PBO||-0.08|-4.22|
71722032|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.2|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-2.48|2.1||||||Day 169 Cohort C: TIP, Pooled PBO||2.10|-2.48|
71887664|NCT04276207|143296406|SUPERIORITY|||||||0.945|||||||Mixed Models Analysis|||Day 1||||0.945
71722033|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-2.33|2.13||||||Day 169 Cohort C: TIP/PBO, Pooled PBO||2.13|-2.33|
71722034|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-0.7|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|95.0|-2.24|0.86||||||Day 169: Pooled TIP, Pooled PBO||0.86|-2.24|
71887665|NCT04276207|143296406|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||Day 2||||0.888
71887666|NCT05099640|143296462|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||||-328.66|-463.07|<0.0001
71887667|NCT05099640|143296463|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||||-54.35|-74.09|<0.0001
71887668|NCT05099640|143296464|OTHER||Odds Ratio (OR)|30.33|||<|0.0001|TWO_SIDED|95.0|5.3|294.24|||Chi-squared|||||294.24|5.30|<0.0001
71887669|NCT05099640|143296465|OTHER||Odds Ratio (OR)|51.54|||<|0.0001|TWO_SIDED|95.0|12.28|245.34|||Chi-squared|||||245.34|12.28|<0.0001
71887670|NCT05099640|143296466|OTHER||LS Mean Difference|-289.89|STANDARD_ERROR_OF_MEAN|33.44|<|0.0001|TWO_SIDED|95.0|-356.29|-223.5|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-223.50|-356.29|<0.0001
71887671|NCT05099640|143296466|OTHER||LS Mean Difference|-375.47|STANDARD_ERROR_OF_MEAN|30.424|<|0.0001|TWO_SIDED|95.0|-435.88|-315.06|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-315.06|-435.88|<0.0001
71887672|NCT05099640|143296466|OTHER||LS Mean Difference|-395.87|STANDARD_ERROR_OF_MEAN|33.848|<|0.0001|TWO_SIDED|95.0|-463.07|-328.66|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-328.66|-463.07|<0.0001
71887673|NCT05099640|143296467|OTHER||LS Mean Difference|-42.52|STANDARD_ERROR_OF_MEAN|6.008|<|0.0001|TWO_SIDED|95.0|-54.45|-30.59|||Mixed Models Analysis|||Weeks 1 and 2: Sepiapterin vs. Placebo||-30.59|-54.45|<0.0001
71887674|NCT05099640|143296467|OTHER||LS Mean Difference|-61.03|STANDARD_ERROR_OF_MEAN|4.531|<|0.0001|TWO_SIDED|95.0|-70.02|-52.03|||Mixed Models Analysis|||Weeks 3 and 4: Sepiapterin vs. Placebo||-52.03|-70.02|<0.0001
71887675|NCT05099640|143296467|OTHER||LS Mean Difference|-64.22|STANDARD_ERROR_OF_MEAN|4.973|<|0.0001|TWO_SIDED|95.0|-74.09|-54.35|||Mixed Models Analysis|||Weeks 5 and 6: Sepiapterin vs. Placebo||-54.35|-74.09|<0.0001
71887676|NCT05099640|143296472|OTHER||LS Mean Difference|-492.23|STANDARD_ERROR_OF_MEAN|55.588|<|0.0001|TWO_SIDED|95.0|-614.59|-369.87|||Mixed Models Analysis|||||-369.87|-614.59|<0.0001
71887677|NCT05099640|143296473|OTHER||LS Mean Difference|-74.73|STANDARD_ERROR_OF_MEAN|10.436|<|0.0001|TWO_SIDED|95.0|-97.72|-51.74|||Mixed Models Analysis|||||-51.74|-97.72|<0.0001
71887678|NCT00666926|143296494|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|155.66|||||TWO_SIDED|90.0|109.66|220.95|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||220.95|109.66|
71887679|NCT00666926|143296495|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|315.72|||||TWO_SIDED|90.0|227.6|437.97|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||437.97|227.60|
71887680|NCT00666926|143296496|SUPERIORITY_OR_OTHER||Ratio (percent) test / reference|496.63|||||TWO_SIDED|90.0|206.24|1195.92|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.||1195.92|206.24|
71657185|NCT02944383|142831670|SUPERIORITY|||||||0.06||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0600
71887681|NCT01557166|143296526|SUPERIORITY_OR_OTHER||Estimated treatment difference|-6.1||||0.015||95.0|-11.0|-1.19|||ANCOVA|ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.||Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.||-1.19|-11.0|0.015
71657186|NCT02944383|142831670|SUPERIORITY|||||||0.6878||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.6878
71657187|NCT02944383|142831671|SUPERIORITY|||||||0.0298||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0298
71657188|NCT02944383|142831671|SUPERIORITY|||||||0.0196||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0196
71657189|NCT02944383|142831671|SUPERIORITY|||||||0.2219||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2219
71657190|NCT02944383|142831671|SUPERIORITY|||||||0.4078||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4078
71657191|NCT02944383|142831671|SUPERIORITY||Median Difference (Net)|-15.34||||0.0605|TWO_SIDED|95.0|-31.68|1.3||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||1.30|-31.68|0.0605
71657192|NCT02944383|142831671|SUPERIORITY||Median Difference (Net)|-4.08||||0.1768|TWO_SIDED|95.0|-19.91|7.32||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.32|-19.91|0.1768
71657193|NCT02944383|142831672|SUPERIORITY|||||||0.0084||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0084
71657194|NCT02944383|142831672|SUPERIORITY|||||||0.0047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0047
71657195|NCT02944383|142831672|SUPERIORITY|||||||0.1574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1574
71722035|NCT02712983|142960659|OTHER||LS Mean Diff (SE) vs pooled placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.61|0.4||||||Day 169: Pooled TIP/PBO, Pooled PBO||0.40|-2.61|
71657196|NCT02944383|142831672|SUPERIORITY|||||||0.3235||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3235
71657197|NCT02944383|142831672|SUPERIORITY|||||||0.0367||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0367
71657198|NCT02944383|142831672|SUPERIORITY|||||||0.0948||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0948
71657199|NCT02944383|142831673|SUPERIORITY|||||||0.0037||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0037
71657200|NCT02944383|142831673|SUPERIORITY|||||||0.1328||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1328
71657201|NCT02944383|142831673|SUPERIORITY|||||||0.4364||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4364
71887682|NCT02986230|143296536|SUPERIORITY||Odds Ratio (OR)|1.07||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index for breast, cervical, and colorectal cancer. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
71887683|NCT02986230|143296536|SUPERIORITY||Odds Ratio (OR)|0.91||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on the composite of cancer screening by 1 year post-index date for breast, cervical, and colorectal cancer. Model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in randomization process. Tests of the planned contrasts were 2-sided with P-values \< 0.025 considered statistically significant.||||.025
71887684|NCT02986230|143296537|SUPERIORITY||Odds Ratio (OR)|1.04||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
71887685|NCT02986230|143296537|SUPERIORITY||Odds Ratio (OR)|0.71||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of the HPV vaccination series by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
71887686|NCT02986230|143296538|SUPERIORITY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the effect of the intervention on completion of lung cancer screening by 12 months post-index date. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
71722036|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.14|3.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.18|0.14|
71722037|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.18|1.85|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.85|0.18|
71722038|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.42|3.77|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.77|0.42|
71722039|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.2|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||1.83|0.20|
71722040|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.21|2.17|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||2.17|0.21|
71722041|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.44|3.62|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||3.62|0.44|
71722042|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.44|2.23|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||2.23|0.44|
71657202|NCT02944383|142831673|SUPERIORITY|||||||0.8129||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.8129
71657203|NCT02944383|142831673|SUPERIORITY||Median Difference (Net)|-15.29||||0.0347|TWO_SIDED|95.0|-36.54|2.35||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||2.35|-36.54|0.0347
71657204|NCT02944383|142831673|SUPERIORITY||Median Difference (Net)|-2.14||||0.3617|TWO_SIDED|95.0|-25.78|23.62||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||23.62|-25.78|0.3617
71657205|NCT02944383|142831674|SUPERIORITY|||||||0.0085||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0085
71722043|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.34|1.71|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.71|0.34|
71722044|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.08|1.83|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||1.83|0.08|
71769375|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|22.0|||||TWO_SIDED|95.0|16.5|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.6|16.5|
71769376|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|14.6|28.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||28.9|14.6|
71769377|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|16.4|35.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||35.3|16.4|
71769378|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|68.0|||||TWO_SIDED|95.0|60.8|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|60.8|
71769379|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|74.0|||||TWO_SIDED|95.0|65.3|81.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||81.3|65.3|
71769380|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|64.0|||||TWO_SIDED|95.0|53.6|72.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||72.3|53.6|
71657206|NCT02944383|142831674|SUPERIORITY|||||||0.2112||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2112
71722045|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.25|2.89|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.89|0.25|
71722046|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.25|3.93|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.93|0.25|
71769381|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|14.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.0|3.7|
71657207|NCT02944383|142831674|SUPERIORITY|||||||0.7301||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.7301
71657208|NCT02944383|142831674|SUPERIORITY|||||||0.6283||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6283
71887687|NCT02986230|143296538|SUPERIORITY||Odds Ratio (OR)|1.02||||0.025|TWO_SIDED|||||Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant, and odds ratios for key study group contrasts report 97.5% confidence intervals.|Mixed Models Analysis|Denominator degrees of freedom for variables in the model take into account the cluster-randomized design.||Generalized linear mixed models with a logit link and binomial error distribution were used to test the intervention effect on the completion of lung cancer screening by 12 months post-index. The model included two primary contrasts: CP-CDS vs. UC and CP-CDS+SDMT vs. UC and included pre-specified covariates and variables used in the randomization process. Tests of the two planned contrasts were 2-sided with P-values less than 0.025 considered statistically significant.||||.025
71887688|NCT03550066|143296565|NON_INFERIORITY|The non-inferiority limit, d, is selected as the largest difference that is clinically acceptable. Here the non-inferiority limit is d=.6 (a medium to large effect size).||||||0.18||||||Threshold for statistical significance: \<.05|t-test, 2 sided|||||||0.18
71887689|NCT01469000|143296568|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.009|TWO_SIDED|95.0|0.48|0.93||1-sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.93|0.48|0.009
71887690|NCT01469000|143296569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.005|TWO_SIDED|95.0|0.46|0.9||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||0.90|0.46|0.005
71887691|NCT01469000|143296570|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.105|TWO_SIDED|95.0|0.51|1.16||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.||||1.16|0.51|0.105
71887692|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.77|1.78||||||Patient-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.78|0.77|
71887693|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.6|1.42||||||Patient-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.42|0.60|
71887694|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.84|2.3||||||Patient-rated Cough: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.30|0.84|
71887695|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.65|1.71||||||Patient-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.71|0.65|
71887696|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.32|1.02||||||Patient-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.02|0.32|
71887697|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.64|1.91||||||Patient-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.91|0.64|
71887698|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.68|1.77||||||Patient-rated Overall Symptoms: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.77|0.68|
71887699|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.88|2.17||||||Patient-rated Interference: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||2.17|0.88|
71887700|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.72|1.74||||||Patient-rated Quality of Life: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).||1.74|0.72|
71887701|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.97|2.49||||||Observer-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.49|0.97|
71887702|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||Observer-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.93|0.82|
71887703|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.15||||||Observer-rated Cough:Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.15|0.72|
71887704|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.64|1.83||||||Observer-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.83|0.64|
71887705|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.6|2.91||||||Observer-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||2.91|0.60|
71887706|NCT01469000|143296574|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.41|1.03||||||Observer-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)||1.03|0.41|
71887707|NCT00632853|143296603|SUPERIORITY|||||||0.8741|||||||Log Rank|||||||0.8741
71887708|NCT00654498|143296650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.52|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|-6.58|-2.46|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-2.46|-6.58|<0.0001
71887709|NCT00654498|143296651|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
71657209|NCT02944383|142831674|SUPERIORITY|||||||0.0919||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0919
71657210|NCT02944383|142831674|SUPERIORITY|||||||0.5497||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.5497
71657211|NCT02944383|142831675|SUPERIORITY|||||||0.0009||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0009
71657212|NCT02944383|142831675|SUPERIORITY|||||||0.0351||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0351
71722047|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.19|2.36|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.36|0.19|
71722048|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.19|||||TWO_SIDED|95.0|0.02|1.57|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.57|0.02|
71722049|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.16|2.41|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||2.41|0.16|
71722050|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.13|1.31|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.31|0.13|
71887710|NCT00654498|143296652|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
71887711|NCT00654498|143296653|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|test stratified by centre||||||<0.0001
71887712|NCT00654498|143296654|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||Chi-squared|||||||0.1386
71887713|NCT00654498|143296655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.14|-0.83|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.83|-2.14|<0.0001
71657213|NCT02944383|142831675|SUPERIORITY|||||||0.1561||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1561
71722051|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.8|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||1.80|0.28|
71722052|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|10.71|||||TWO_SIDED|95.0|1.1|104.19|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||104.19|1.10|
71887714|NCT00654498|143296656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-1.99|-0.73|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.73|-1.99|<0.0001
71657214|NCT02944383|142831675|SUPERIORITY|||||||0.0268||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0268
71887715|NCT00654498|143296657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.0|-0.72|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.72|-2.00|<0.0001
71887716|NCT00654498|143296658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0402|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.02|-1.06|0.0402
71887717|NCT00654498|143296659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0771|TWO_SIDED|95.0|-0.69|0.04|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||0.04|-0.69|0.0771
71657215|NCT02944383|142831675|SUPERIORITY||Median Difference (Net)|-22.3||||0.0516|TWO_SIDED|95.0|-42.96|-1.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.67|-42.96|0.0516
71657216|NCT02944383|142831675|SUPERIORITY||Median Difference (Net)|-13.06||||0.0125|TWO_SIDED|95.0|-32.83|4.88||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||4.88|-32.83|0.0125
71657217|NCT02944383|142831676|SUPERIORITY|||||||0.0023||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0023
71657218|NCT02944383|142831676|SUPERIORITY|||||||0.0356||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0356
71657219|NCT02944383|142831676|SUPERIORITY|||||||0.2284||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2284
71657220|NCT02944383|142831676|SUPERIORITY|||||||0.0213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0213
71657221|NCT02944383|142831676|SUPERIORITY|||||||0.033||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0330
71722053|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|4.62|||||TWO_SIDED|95.0|0.41|52.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||52.29|0.41|
71722054|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|3.23|||||TWO_SIDED|95.0|0.28|37.06|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||37.06|0.28|
71722055|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.1|25.94|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||25.94|0.10|
71829763|NCT03622593|143163797|SUPERIORITY||Difference in CMH Weighted Percentage|-3.5||||0.4293|TWO_SIDED|97.5|-13.4|6.3||Tested at an overall significance level of α = 0.0248.|Cochran-Mantel-Haenszel|||This analysis is for the superiority of Arm B: Faricimab 6 mg PTI compared with Arm C: Aflibercept 2 mg Q8W in the ITT Population.||6.3|-13.4|0.4293
71829764|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|3.5|||||TWO_SIDED|95.0|-4.0|11.1||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.1|-4.0|
71829765|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|-2.0|||||TWO_SIDED|95.0|-9.1|5.2||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-9.1|
71887718|NCT00654498|143296660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.25||0.0048|TWO_SIDED|95.0|-1.2|-0.22|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||-0.22|-1.20|0.0048
71657222|NCT02944383|142831676|SUPERIORITY|||||||0.0221||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0221
71657223|NCT02944383|142831677|SUPERIORITY||Median Difference (Net)|-2.67||||0.2632|TWO_SIDED|95.0|-10.17|5.67||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||5.67|-10.17|0.2632
71657224|NCT02944383|142831677|SUPERIORITY||Median Difference (Net)|2.02||||0.5382|TWO_SIDED|95.0|-6.77|9.71||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL||9.71|-6.77|0.5382
71829766|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.5|13.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||13.4|-2.5|
71829767|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.9|6.8||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.8|-8.9|
71722056|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|11.3|||||TWO_SIDED|95.0|1.09|117.34|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||117.34|1.09|
71829768|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|3.8|||||TWO_SIDED|95.0|-2.7|10.3||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||10.3|-2.7|
71887719|NCT00654498|143296661|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate||||||<0.0001
71722057|NCT02712983|142960660|OTHER||Hazard Ratio (HR)|4.3|||||TWO_SIDED|95.0|0.5|37.32|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Pooled TIP, Pooled PBO||37.32|0.50|
71722058|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|9.8|STANDARD_ERROR_OF_MEAN|18.15|||TWO_SIDED|95.0|-27.15|46.81|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP, Pooled PBO||46.81|-27.15|
71722059|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|19.8|STANDARD_ERROR_OF_MEAN|20.81|||TWO_SIDED|95.0|-22.63|62.14|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort A: TIP/PBO, Pooled PBO||62.14|-22.63|
71722060|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|8.0|STANDARD_ERROR_OF_MEAN|19.29|||TWO_SIDED|95.0|-31.32|47.26|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP, Pooled PBO||47.26|-31.32|
71722061|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|12.7|STANDARD_ERROR_OF_MEAN|19.24|||TWO_SIDED|95.0|-26.49|51.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort B: TIP/PBO, Pooled PBO||51.89|-26.49|
71722062|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|46.5|STANDARD_ERROR_OF_MEAN|21.17|||TWO_SIDED|95.0|3.37|89.61|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP, Pooled PBO||89.61|3.37|
71722063|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|3.2|STANDARD_ERROR_OF_MEAN|18.37|||TWO_SIDED|95.0|-34.21|40.64|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Cohort C: TIP/PBO, Pooled PBO||40.64|-34.21|
71722064|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|21.4|STANDARD_ERROR_OF_MEAN|14.46|||TWO_SIDED|95.0|-8.03|50.89|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP, Pooled PBO||50.89|-8.03|
71722065|NCT02712983|142960661|OTHER||LS Mean Diff (SE) vs pooled placebo|11.9|STANDARD_ERROR_OF_MEAN|14.44|||TWO_SIDED|95.0|-17.52|41.29|||||ANCOVA model includes treatment as a fixed-effect factor and number of pulmonary exacerbations in the 12 months prior to screening as a covariate.|Overall Pooled TIP/PBO, Pooled PBO||41.29|-17.52|
71722066|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.51|3.13|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP, Pooled PBO||3.13|0.51|
71722067|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.15|1.46|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort A: TIP/PBO, Pooled PBO||1.46|0.15|
71722068|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.21|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP, Pooled PBO||3.21|0.44|
71722069|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.32|2.18|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort B: TIP/PBO, Pooled PBO||2.18|0.32|
71722070|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.1|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP, Pooled PBO||1.27|0.10|
71722071|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.43|2.99|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Cohort C: TIP/PBO, Pooled PBO||2.99|0.43|
71722072|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.76|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP, Pooled PBO||1.76|0.37|
71722073|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.36|1.61|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Overall Pooled TIP/PBO, Pooled PBO||1.61|0.36|
71722074|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.3|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP, Pooled PBO||2.55|0.30|
71769382|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|7.0|||||TWO_SIDED|95.0|3.3|12.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.3|3.3|
71769383|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|4.5|22.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.0|4.5|
71769384|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|5.0|||||TWO_SIDED|95.0|-3.4|12.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.8|-3.4|
71722075|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.2|2.03|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort A: TIP/PBO, Pooled PBO||2.03|0.20|
71722076|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.4|3.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP, Pooled PBO||3.60|0.40|
71722077|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.31|2.55|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort B: TIP/PBO, Pooled PBO||2.55|0.31|
71722078|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.06|1.27|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP, Pooled PBO||1.27|0.06|
71722079|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.45|3.73|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Cohort C: TIP/PBO, Pooled PBO||3.73|0.45|
71722080|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.27|1.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP, Pooled PBO||1.60|0.27|
71722081|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.4|2.02|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Oral Pooled TIP/PBO, Pooled PBO||2.02|0.40|
71769385|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|9.0|||||TWO_SIDED|95.0|-3.3|21.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.4|-3.3|
71769386|NCT02446743|143039178|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-6.4|14.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.5|-6.4|
71722082|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|3.72|||||TWO_SIDED|95.0|0.84|16.52|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort A: TIP, Pooled PBO||16.52|0.84|
71722083|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.22|8.16|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP, Pooled PBO||8.16|0.22|
71722084|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|2.15|||||TWO_SIDED|95.0|0.46|10.05|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort B: TIP/PBO, Pooled PBO||10.05|0.46|
71722085|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.05|4.87|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP, Pooled PBO||4.87|0.05|
71722086|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|2.56|||||TWO_SIDED|95.0|0.53|12.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Parenteral Cohort C: TIP/PBO, Pooled PBO||12.49|0.53|
71722087|NCT02712983|142960666|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.33|5.68|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Paremteral Pooled TIP, Pooled PBO||5.68|0.33|
71722088|NCT02712983|142960671|OTHER||Odds Ratio, log|5.62|||||TWO_SIDED|95.0|0.83|38.18|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||38.18|0.83|
71722089|NCT02712983|142960671|OTHER||Odds Ratio, log|2.0|||||TWO_SIDED|95.0|0.21|19.16|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||19.16|0.21|
71722090|NCT02712983|142960671|OTHER||Odds Ratio, log|3.05|||||TWO_SIDED|95.0|0.43|21.8|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||21.80|0.43|
71769387|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|10.1|20.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|10.1|
71769388|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|12.0|||||TWO_SIDED|95.0|7.5|18.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.1|7.5|
71722091|NCT02712983|142960671|OTHER||Odds Ratio, log|1.84|||||TWO_SIDED|95.0|0.19|17.42|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||17.42|0.19|
71722092|NCT02712983|142960671|OTHER||Odds Ratio, log|3.41|||||TWO_SIDED|95.0|0.47|25.03|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||25.03|0.47|
71722093|NCT02712983|142960671|OTHER||Odds Ratio, log|2.74|||||TWO_SIDED|95.0|0.47|16.07|||||Generalized linear model assuming the negative binomial distribution including treatment and baseline macrolide use as class-effect factors. The log exposure to study in years is included as an offset variable in the model.|||16.07|0.47|
71722094|NCT02712983|142960672|OTHER||Hazard Ratio (HR)|4.5|||||TWO_SIDED|95.0|0.77|26.42|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort A (3 capsules o.d.): TIP, Pooled PBO||26.42|0.77|
71722095|NCT02712983|142960672|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.28|14.47|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP, Pooled PBO||14.47|0.28|
71722096|NCT02712983|142960672|OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.2|11.6|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort B (5 capsules o.d.): TIP/PBO, Pooled PBO||11.60|0.20|
71722097|NCT02712983|142960672|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.06|7.49|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP, Pooled PBO||7.49|0.06|
71722098|NCT02712983|142960672|OTHER||Hazard Ratio (HR)|3.81|||||TWO_SIDED|95.0|0.62|23.29|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Cohort C (4 capsules b.i.d.): TIP/PBO, Pooled PBO||23.29|0.62|
71722099|NCT02712983|142960672|OTHER||Hazard Ratio (HR)|1.82|||||TWO_SIDED|95.0|0.35|9.45|||||Based on Cox proportional hazards model with treatment as fixed effect and number of pulmonary exacerbations in the 12 months prior to screening as a covariate, stratified by baseline macrolide use.|Pooled TIP, Pooled PBO||9.45|0.35|
71722100|NCT05360966|142960692|OTHER|Difference (2-sided)|Difference in Percentages|38.8|||<|0.0001|TWO_SIDED|95.0|30.8|46.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|46.8|30.8|<0.0001
71722101|NCT05360966|142960693|OTHER|Difference (2-sided)|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.08||0.1321|TWO_SIDED|95.0|-7.2|0.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center.|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||0.9|-7.2|0.1321
71722102|NCT05360966|142960694|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.3|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|6.9|9.8||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.8|6.9|<0.0001
71722103|NCT05360966|142960695|OTHER|Difference (2-sided)|Difference in Percentages|40.1|||<|0.0001|TWO_SIDED|95.0|32.3|47.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|47.9|32.3|<0.0001
71829769|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-7.3|5.9||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.9|-7.3|
71722104|NCT05360966|142960696|OTHER|Difference (2-sided)|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|0.67|<|0.0001|TWO_SIDED|95.0|6.3|8.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||8.9|6.3|<0.0001
71722105|NCT05360966|142960697|OTHER|Difference (2 sided)|Difference in Percentages|37.3|||<|0.0001|TWO_SIDED|95.0|28.7|45.9||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|Pearson's Chi-squared test||Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.|For binary endpoint, the underlying continuous measurement of unanesthetized Schirmer score was imputed, change score calculated and then dichotomized to ascertain attainment of greater than or equal to 10 millimeter increase from pre-drop baseline.|45.9|28.7|<0.0001
71722106|NCT05360966|142960698|OTHER|Difference (2-sided)|Least Squares Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|6.5|9.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||9.6|6.5|<0.0001
71722107|NCT05360966|142960699|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.4||0.5626|TWO_SIDED|95.0|-6.1|3.3||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.3|-6.1|0.5626
71722108|NCT05360966|142960700|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.53||0.5981|TWO_SIDED|95.0|-6.3|3.6||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.6|-6.3|0.5981
71722109|NCT05360966|142960701|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.44||0.5161|TWO_SIDED|95.0|-6.4|3.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||3.2|-6.4|0.5161
71769389|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|12.3|29.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||29.9|12.3|
71769390|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|66.0|||||TWO_SIDED|95.0|59.6|72.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||72.4|59.6|
71829770|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|0.7|||||TWO_SIDED|95.0|-3.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||5.2|-3.8|
71829771|NCT03622593|143163800|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-4.9|4.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.2|-4.9|
71829772|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-8.5|8.9||||||This is the difference in percentage of participants gaining ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.9|-8.5|
71722110|NCT05360966|142960702|OTHER|Difference (2-sided)|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.51||0.8574|TWO_SIDED|95.0|-4.5|5.4||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||5.4|-4.5|0.8574
71722111|NCT05360966|142960703|OTHER|Difference (2-sided)|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.69||0.698|TWO_SIDED|95.0|-6.3|4.2||Multiple imputation methodology was implemented in handling missing data, both related to and unrelated to intercurrent events.|ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|Difference equals 0.003% AR-15512 minus AR-15512 Vehicle|The primary estimand targeted the treatment effect attributable to the randomly assigned treatment, regardless of compliance to study treatment and assuming subjects who discontinued due to lack of efficacy, AEs, or disallowed concurrent treatments followed the behavior of subjects in the reference arm for the duration of the study and subjects who discontinued for other reasons would have followed the behavior of subjects who were still in the study under same randomly assigned treatment.||4.2|-6.3|0.6980
71722112|NCT05926544|142960723|SUPERIORITY||Risk Ratio (RR)|0.46|||||TWO_SIDED|95.0|0.18|1.16|||||The Standard implementation arm was the reference group.|||1.16|0.18|
71722113|NCT03522246|142960724|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.47||||0.0004|TWO_SIDED|95.0|0.31|0.72|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification and timing of surgery.|||0.72|0.31|0.0004
71722114|NCT03522246|142960725|SUPERIORITY|Rucaparib vs Placebo|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||0.68|0.40|<0.0001
71722115|NCT03522246|142960726|SUPERIORITY|Rucaparib + Nivolumab vs Rucaparib + Placebo|Hazard Ratio (HR)|1.29||||0.0038|TWO_SIDED|95.0|1.08|1.53|||Log Rank||The stratified cox proportional hazard model is adjusted for the randomization strata of HRD classification, disease status post-chemotherapy, and timing of surgery.|||1.53|1.08|0.0038
71722116|NCT04683029|142960739|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|80.0|-13.8|-11.4|||MMRM model|||||-11.4|-13.8|< 0.001
71722117|NCT04683029|142960740|SUPERIORITY||LS Mean Difference|-12.0|||||TWO_SIDED|80.0|-13.3|-10.7||||||||-10.7|-13.3|
71722118|NCT04683029|142960741|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.3||||||Week 24||0.3|0.0|
71722119|NCT04683029|142960741|SUPERIORITY||Odds Ratio (OR)|0.1|||||TWO_SIDED|80.0|0.0|0.2||||||Week 52||0.2|0.0|
71722120|NCT04683029|142960742|SUPERIORITY||Odds Ratio (OR)|203.2|||||TWO_SIDED|80.0|42.1|980.6||||||Week 24||980.6|42.1|
71722121|NCT04683029|142960742|SUPERIORITY||Odds Ratio (OR)|130.3|||||TWO_SIDED|80.0|28.2|601.9||||||Week 52||601.9|28.2|
71722122|NCT04683029|142960743|SUPERIORITY||LS Mean Difference|-47.2|||||TWO_SIDED|80.0|-96.8|2.4||||||Week 24||2.4|-96.8|
71722123|NCT04683029|142960743|SUPERIORITY||LS Mean difference|-14.2|||||TWO_SIDED|80.0|-57.2|28.8||||||Week 52||28.8|-57.2|
71722124|NCT04683029|142960744|SUPERIORITY||LS Mean Difference|0.0|||||TWO_SIDED|80.0|-1.7|1.6||||||Week 24||1.6|-1.7|
71722125|NCT04683029|142960744|SUPERIORITY||LS Mean Difference|0.1|||||TWO_SIDED|80.0|-1.4|1.7||||||Week 52||1.7|-1.4|
71722126|NCT04683029|142960745|SUPERIORITY||LS Mean Difference|-0.08|||||TWO_SIDED|80.0|-0.44|0.27||||||Week 24||0.27|-0.44|
71722127|NCT04683029|142960745|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|80.0|-0.29|0.71||||||Week 52||0.71|-0.29|
71722128|NCT04683029|142960746|SUPERIORITY||LS Mean Difference|-2.08|||||TWO_SIDED|80.0|-3.81|-0.34||||||Week 24||-0.34|-3.81|
71722129|NCT04683029|142960746|SUPERIORITY||LS Mean Difference|0.14|||||TWO_SIDED|80.0|-2.13|2.42||||||Week 52||2.42|-2.13|
71722130|NCT04683029|142960747|SUPERIORITY||LS Mean Difference|-4.9|||||TWO_SIDED|80.0|-5.7|-4.0||||||Week 24||-4.0|-5.7|
71722131|NCT04683029|142960747|SUPERIORITY||LS Mean Difference|-4.3|||||TWO_SIDED|80.0|-5.1|-3.5||||||Week 52||-3.5|-5.1|
71722132|NCT04683029|142960748|SUPERIORITY||LS Mean Difference|-0.4006|||||TWO_SIDED|80.0|-0.5344|-0.2668||||||Week 24||-0.2668|-0.5344|
71722133|NCT04683029|142960748|SUPERIORITY||LS Mean Difference|-0.2355|||||TWO_SIDED|80.0|-0.373|-0.098||||||Week 52||-0.0980|-0.3730|
71722134|NCT01477710|142960759|SUPERIORITY_OR_OTHER_LEGACY||ANOVA F-value|266.39|||<|0.0001||||||This p-value is for the omnibus F-test of between-treatment differences in tidal volume|ANOVA|The p-value for the omnibus F-test was \<0.0001||Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.||||<0.0001
71722135|NCT01477710|142960759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|314.4|||<|0.0001||95.0|264.7|364.1|||t-test, 2 sided|||||364.1|264.7|<0.0001
71722136|NCT01477710|142960759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|576.6|STANDARD_ERROR_OF_MEAN|25.0|<|0.0001|TWO_SIDED|95.0|526.9|626.3|||t-test, 2 sided|||||626.3|526.9|<0.0001
71722137|NCT01477710|142960759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|262.2|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|212.5|312.0|||t-test, 2 sided|||||312.0|212.5|<0.0001
71829773|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|-3.5|||||TWO_SIDED|95.0|-11.8|4.8||||||This is the difference in percentage of participants gaining ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.8|-11.8|
71829774|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|2.2|||||TWO_SIDED|95.0|-6.9|11.4||||||This is the difference in percentage of participants gaining ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||11.4|-6.9|
71829775|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|-0.8|||||TWO_SIDED|95.0|-9.8|8.1||||||This is the difference in percentage of participants gaining ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||8.1|-9.8|
71829776|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.2|8.5||||||This is the difference in percentage of participants gaining ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||8.5|-6.2|
71657225|NCT02944383|142831677|SUPERIORITY||Median Difference (Net)|0.0||||0.1727|TWO_SIDED|95.0|-0.51|1.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||1.01|-0.51|0.1727
71657226|NCT02944383|142831677|SUPERIORITY||Median Difference (Net)|0.0||||0.4567|TWO_SIDED|95.0|-0.51|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL||0.51|-0.51|0.4567
71657227|NCT02944383|142831677|SUPERIORITY||Median Difference (Net)|0.0||||0.6142|TWO_SIDED|95.0|-1.21|1.47||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.47|-1.21|0.6142
71657228|NCT02944383|142831677|SUPERIORITY||Median Difference (Net)|-0.02||||0.2409|TWO_SIDED|95.0|-2.23|1.29||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|HDL||1.29|-2.23|0.2409
71657229|NCT02944383|142831678|SUPERIORITY|||||||0.2721||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.2721
71657230|NCT02944383|142831678|SUPERIORITY|||||||0.5669||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL||||0.5669
71657231|NCT02944383|142831678|SUPERIORITY|||||||0.1686||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.1686
71657232|NCT02944383|142831678|SUPERIORITY|||||||0.4308||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL||||0.4308
71657233|NCT02944383|142831678|SUPERIORITY|||||||0.5495||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.5495
71657234|NCT02944383|142831678|SUPERIORITY|||||||0.2384||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||HDL||||0.2384
71657235|NCT02944383|142831679|SUPERIORITY||Median Difference (Net)|-13.99||||0.0781|TWO_SIDED|95.0|-33.76|2.55||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||2.55|-33.76|0.0781
71657236|NCT02944383|142831679|SUPERIORITY||Median Difference (Net)|-2.1||||0.9901|TWO_SIDED|95.0|-19.36|19.01||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|VLDL \& Chylomicron particles||19.01|-19.36|0.9901
71657237|NCT02944383|142831679|SUPERIORITY||Median Difference (Net)|-25.23||||0.0717|TWO_SIDED|95.0|-43.62|-5.1||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||-5.10|-43.62|0.0717
71657238|NCT02944383|142831679|SUPERIORITY||Median Difference (Net)|-16.09||||0.1548|TWO_SIDED|95.0|-36.78|3.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|LDL Particles||3.76|-36.78|0.1548
71657239|NCT02944383|142831679|SUPERIORITY||Median Difference (Net)|-47.16||||0.0428|TWO_SIDED|95.0|-119.58|-5.78||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||-5.78|-119.58|0.0428
71657240|NCT02944383|142831679|SUPERIORITY||Median Difference (Net)|-26.13||||0.1836|TWO_SIDED|95.0|-121.44|19.48||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|IDL Particles||19.48|-121.44|0.1836
71657241|NCT02944383|142831680|SUPERIORITY|||||||0.1251||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.1251
71829777|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|-1.1|||||TWO_SIDED|95.0|-8.3|6.2||||||This is the difference in percentage of participants gaining ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||6.2|-8.3|
71829778|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-3.8|6.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||6.2|-3.8|
71722138|NCT00814580|142960764|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (\< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.|Least square mean difference|9.0|STANDARD_ERROR_OF_MEAN|14.2||0.5265|TWO_SIDED|95.0|-18.9|36.9||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||Tapentadol IR versus Oxycodone IR||36.9|-18.9|0.5265
71722139|NCT00814580|142960765|SUPERIORITY_OR_OTHER|||||||0.7306||95.0|||||Log Rank|||||||0.7306
71722140|NCT00814580|142960766|SUPERIORITY_OR_OTHER|||||||0.8524||95.0|||||Log Rank|||||||0.8524
71722141|NCT00814580|142960767|SUPERIORITY_OR_OTHER|||||||0.9078||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.9078
71722142|NCT00814580|142960768|SUPERIORITY_OR_OTHER|||||||0.2633||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2633
71722143|NCT00814580|142960769|SUPERIORITY_OR_OTHER|||||||0.4498||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.4498
71722144|NCT00814580|142960770|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.2158
71722145|NCT00814580|142960771|SUPERIORITY_OR_OTHER||Least square mean difference|6.6|STANDARD_ERROR_OF_MEAN|9.34||0.4811|TWO_SIDED|95.0|-11.8|25.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||25.0|-11.8|0.4811
71887720|NCT02531646|143296663|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
71887721|NCT02531646|143296664|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test|||||||0.000
71657242|NCT02944383|142831680|SUPERIORITY|||||||0.9047||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||VLDL \& Chylomicron Particles||||0.9047
71722146|NCT00814580|142960772|SUPERIORITY_OR_OTHER||Least square mean difference|-9.3|STANDARD_ERROR_OF_MEAN|28.13||0.7405|TWO_SIDED|95.0|-64.7|46.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||46.0|-64.7|0.7405
71722147|NCT00814580|142960773|SUPERIORITY_OR_OTHER||Least square mean difference|-5.6|STANDARD_ERROR_OF_MEAN|5.53||0.3097|TWO_SIDED|95.0|-16.5|5.3||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.3|-16.5|0.3097
71722148|NCT00814580|142960774|SUPERIORITY_OR_OTHER||Least square mean difference|-10.3|STANDARD_ERROR_OF_MEAN|8.34||0.2179|TWO_SIDED|95.0|-26.7|6.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||6.1|-26.7|0.2179
71722149|NCT00814580|142960775|SUPERIORITY_OR_OTHER||Least square mean difference|-26.3|STANDARD_ERROR_OF_MEAN|16.16||0.1051|TWO_SIDED|95.0|-58.1|5.5||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||5.5|-58.1|0.1051
71722150|NCT00814580|142960776|SUPERIORITY_OR_OTHER||Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|12.09||0.9367|TWO_SIDED|95.0|-22.8|24.8||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||24.8|-22.8|0.9367
71722151|NCT00814580|142960777|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|18.53||0.9441|TWO_SIDED|95.0|-37.8|35.2||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||35.2|-37.8|0.9441
71722152|NCT00814580|142960778|SUPERIORITY_OR_OTHER||Least square mean difference|-35.6|STANDARD_ERROR_OF_MEAN|37.45||0.3427|TWO_SIDED|95.0|-109.3|38.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||||38.1|-109.3|0.3427
71769391|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|70.0|||||TWO_SIDED|95.0|60.8|77.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||77.0|60.8|
71722153|NCT00814580|142960779|SUPERIORITY_OR_OTHER|||||||0.1618||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.1618
71722154|NCT00814580|142960780|SUPERIORITY_OR_OTHER|||||||0.0481||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel|||||||0.0481
71722155|NCT00814580|142960781|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers|Cochran-Mantel-Haenszel|||||||0.0109
71722156|NCT02482428|142960798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.07||0.862|TWO_SIDED|90.0|-0.03|0.2|||Posterior mean|||||0.20|-0.03|0.862
71722157|NCT02482428|142960798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.07||0.541|TWO_SIDED|90.0|-0.07|0.19|||posterior mean|||||0.19|-0.07|0.541
71887722|NCT02531646|143296665|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
71887723|NCT02531646|143296666|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
71722158|NCT04075292|142960814|SUPERIORITY||Hazard Ratio (HR)|0.08|||<|0.0001|TWO_SIDED|95.0|0.03|0.18|||Log Rank|The analysis was performed using the unstratified log-rank test.|HR was calculated using an unstratified Cox model with treatment as the only covariate. The CI for HR was calculated using the profile likelihood method.|||0.18|0.03|<0.0001
71722159|NCT00241176|142960869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)||YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).|Group 1 Baseline vs. Endpoint||||<.05
71722160|NCT00241176|142960870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)||Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).|Mean scores baseline to endpoint||||<.05
71722161|NCT03206970|142960888|OTHER||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<.0001
71722162|NCT03206970|142960892|SUPERIORITY||Clopper-Pearson|83.7|||<|0.0001|TWO_SIDED|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)||90.8|74.2|<0.0001
71722163|NCT02516982|142960897|SUPERIORITY|||||||0.994|||||||Chi-squared, Corrected|||||||0.994
71722164|NCT02516982|142960898|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
71722165|NCT02516982|142960899|SUPERIORITY|||||||0.008|||||||Chi-squared, Corrected|||||||0.008
71722166|NCT02516982|142960900|SUPERIORITY|||||||0.919|||||||Chi-squared, Corrected|||||||0.919
71722167|NCT02516982|142960901|SUPERIORITY|||||||0.0001467|||||||Chi-squared, Corrected|||||||0.0001467
71722168|NCT02516982|142960902|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71722169|NCT02516982|142960903|SUPERIORITY|||||||0.869|||||||Chi-squared, Corrected|||||||0.869
71722170|NCT01129765|142960905|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Proportion responding \>=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.||1.0|0.83|
71722171|NCT01129765|142960906|SUPERIORITY_OR_OTHER||Proportion|0.97|||||TWO_SIDED|95.0|0.83|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.83|
71722172|NCT01129765|142960907|SUPERIORITY_OR_OTHER||Proportion|0.97||||0.0005|TWO_SIDED|95.0|0.83|1.0|||One-sample proportion|||"Null hypothesis: Pr ≤ 0.7 versus HA: Pr \> 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%."||1.0|0.83|0.0005
71722173|NCT01129765|142960908|SUPERIORITY_OR_OTHER||Proportion|1.0|||||TWO_SIDED|95.0|0.88|1.0|||Descriptive|||Descriptive summary of proportion responding \>=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.||1.0|0.88|
71722174|NCT01129765|142960909|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
71722175|NCT01129765|142960910|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.12|||Descriptive|||Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.||0.12|0|
71722176|NCT01814878|142961002|NON_INFERIORITY_OR_EQUIVALENCE|Study drug treatment group was considered non-inferior to comparator treatment group, if lower limit of the confidence interval was larger than -2.0|Mean Difference (Final Values)|-4.68||||0.1648|TWO_SIDED|95.0|-11.29|1.93||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||Non-inferiority comparison for Tramadol Hydrochloride/Acetaminophen ER to Tramadol HCl/Acetaminophen IR was performed.||1.93|-11.29|0.1648
71722177|NCT01814878|142961003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4082|TWO_SIDED|95.0|-1.1|0.45||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||0.45|-1.10|0.4082
71722178|NCT01814878|142961003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.172|TWO_SIDED|95.0|-2.68|0.48||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||0.48|-2.68|0.1720
71722179|NCT01814878|142961003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.0589|TWO_SIDED|95.0|-6.09|0.11||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||0.11|-6.09|0.0589
71722180|NCT01814878|142961004|SUPERIORITY_OR_OTHER|||||||0.1542||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1542
71722181|NCT01814878|142961004|SUPERIORITY_OR_OTHER|||||||0.0714||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0714
71722182|NCT01814878|142961004|SUPERIORITY_OR_OTHER|||||||0.1147||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.1147
71722183|NCT01814878|142961004|SUPERIORITY_OR_OTHER|||||||0.2209||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.2209
71722184|NCT01814878|142961005|SUPERIORITY_OR_OTHER|||||||0.1498||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test|||||||0.1498
71722185|NCT01814878|142961005|SUPERIORITY_OR_OTHER|||||||0.0485||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test|||||||0.0485
71722186|NCT01814878|142961005|SUPERIORITY_OR_OTHER|||||||0.0404||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test|||||||0.0404
71722187|NCT01814878|142961005|SUPERIORITY_OR_OTHER|||||||0.121||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||||||0.1210
71722188|NCT01814878|142961006|SUPERIORITY_OR_OTHER|||||||0.4216||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.4216
71722189|NCT01814878|142961007|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.1000
71722190|NCT01814878|142961008|SUPERIORITY_OR_OTHER|||||||0.3255||||||P-value was calculated using Mann-Whitney's U test.|Wilcoxon (Mann-Whitney)|||||||0.3255
71722191|NCT01814878|142961009|SUPERIORITY_OR_OTHER|||||||0.2848||||||Day 3: P-value was calculated using student's t-test|Student's t-test|||||||0.2848
71887724|NCT02531646|143296667|SUPERIORITY_OR_OTHER|||||||0.007||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.007
71722192|NCT03645421|142961012|OTHER||Least squares (LS) mean difference|-42.11|STANDARD_ERROR_OF_MEAN|4.16|<|0.0001|TWO_SIDED|95.0|-50.47|-33.75|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-33.75|-50.47|<0.0001
71657243|NCT02944383|142831680|SUPERIORITY|||||||0.0788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.0788
71722193|NCT03645421|142961012|OTHER||LS mean difference|-33.61|STANDARD_ERROR_OF_MEAN|4.69|<|0.0001|TWO_SIDED|95.0|-43.04|-24.18|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-24.18|-43.04|<0.0001
71722194|NCT03645421|142961012|OTHER||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|4.57|<|0.0001|TWO_SIDED|95.0|-49.49|-31.12|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-31.12|-49.49|<0.0001
71722195|NCT03645421|142961013|OTHER||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.89||0.1476|TWO_SIDED|95.0|-3.08|0.47|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||0.47|-3.08|0.1476
71722196|NCT03645421|142961013|OTHER||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|0.92||0.008|TWO_SIDED|95.0|-4.37|-0.69|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.69|-4.37|0.0080
71722197|NCT03645421|142961013|OTHER||LS mean difference|-2.52|STANDARD_ERROR_OF_MEAN|0.89||0.0063|TWO_SIDED|95.0|-4.3|-0.74|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.74|-4.30|0.0063
71722198|NCT03645421|142961016|OTHER||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.48|-0.7|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.70|-1.48|<0.0001
71722199|NCT03645421|142961016|OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.49|-0.71|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.71|-1.49|<0.0001
71722200|NCT03645421|142961016|OTHER||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.38|-1.15|0.0002
71722201|NCT03645421|142961017|OTHER||LS mean difference|-56.69|STANDARD_ERROR_OF_MEAN|8.75|<|0.0001|TWO_SIDED|95.0|-74.3|-39.09|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-39.09|-74.30|<0.0001
71722202|NCT03645421|142961017|OTHER||LS mean difference|-60.58|STANDARD_ERROR_OF_MEAN|9.92|<|0.0001|TWO_SIDED|95.0|-80.53|-40.63|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-40.63|-80.53|<0.0001
71722203|NCT03645421|142961017|OTHER||LS mean difference|-55.07|STANDARD_ERROR_OF_MEAN|9.55|<|0.0001|TWO_SIDED|95.0|-74.28|-35.86|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-35.86|-74.28|<0.0001
71722204|NCT03645421|142961018|OTHER||LS mean difference|-0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.094|-0.047|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.||-0.047|-0.094|<0.0001
71722205|NCT03645421|142961018|OTHER||LS mean difference|-0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.077|-0.03|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.||-0.030|-0.077|<0.0001
71722206|NCT03645421|142961018|OTHER||LS mean difference|-0.049|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.074|-0.024|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.||-0.024|-0.074|0.0002
71769392|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|65.0|||||TWO_SIDED|95.0|55.2|73.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||73.7|55.2|
71722207|NCT02253433|142961030|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.575|TWO_SIDED|95.0|-0.87|2.07|||Mixed Models Analysis|||||2.07|-.87|0.575
71722208|NCT02253433|142961031|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.141|TWO_SIDED|95.0|-0.18|0.68|||Mixed Models Analysis|||||.68|-.18|0.141
71722209|NCT02253433|142961032|SUPERIORITY||Odds Ratio (OR)|0.86||||0.043|TWO_SIDED|95.0|0.47|1.57|||Mixed Models Analysis|ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).||||1.57|.47|0.043
71722210|NCT03636893|142961066|OTHER|Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.06||||0.842|TWO_SIDED|95.0|0.597|1.884||P-value from two-sided log-rank test. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Disease-free survival analysis in intention-to-treat population. DFS defined as time from randomization to first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause.|Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios.|1.884|0.597|0.842
71722211|NCT03636893|142961067|OTHER|Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P \<0.05.|Hazard Ratio (HR)|1.101||||0.759|TWO_SIDED|95.0|0.595|2.036||P-value from two-sided log-rank test. No adjustment for multiple comparisons as overall survival was a pre-specified secondary endpoint. Alpha level set at 0.05.|Log Rank|Kaplan-Meier survival analysis with log-rank test for between-group comparison. Analysis performed using SPSS version 30.0.|Hazard ratio from Cox proportional hazards regression with FLOT as reference group.|Primary survival analysis comparing overall survival between neoadjuvant FLOT and SOX regimens in intention-to-treat population.|Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors.|2.036|0.595|0.759
71722212|NCT02277691|142961094|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 12 (LOCF).||||<0.0001
71722213|NCT02277691|142961094|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 52 (LOCF).||||<0.0001
71722214|NCT02277691|142961094|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 12 (LOCF).||||<0.0001
71722215|NCT02277691|142961094|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 52 (LOCF).||||<0.0001
71722216|NCT02277691|142961095|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at End of Week 12.||||<0.0001
71722217|NCT02277691|142961095|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at EOT (Up to Week 52).||||<0.0001
71722218|NCT02277691|142961095|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at End of Week 12.||||<0.0001
71722219|NCT02277691|142961095|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at EOT (Up to Week 52).||||<0.0001
71722220|NCT03818607|142961096|NON_INFERIORITY|The clinical similarity of the Week 27 LDH between treatments was assessed by comparing the 1-sided 97.5% upper confidence interval (CI) limit for the geometric mean ratio of LDH at Week 27 between ABP 959 treatment and eculizumab treatment with a non-inferiority margin of 2.873.|Geometric LS mean ratio (GMR)|1.0628|||||ONE_SIDED|97.5||1.1576||||||||1.1576||
71722221|NCT03818607|142961097|OTHER|The clinical similarity of the AUEC between treatments was assessed by comparing 2-sided 90% CI for the GMR of the time-adjusted AUEC of LDH (Week 13 to Week 27, Week 39 to Week 53, and Week 65 to Week 79) between ABP 959 treatment and eculizumab treatment with a similarity margin of (0.77, 1.30).|GMR|0.9812|||||TWO_SIDED|90.0|0.9403|1.0239||||||||1.0239|0.9403|
71722222|NCT03818607|142961105|OTHER||GMR|1.0314|||||ONE_SIDED|97.5||1.1201||||||||1.1201||
71722223|NCT03818607|142961108|OTHER||GMR|0.9122|||||TWO_SIDED|90.0|0.7586|1.0968||||||Total PK AUC GMR (ABP 959/Eculizumab)||1.0968|0.7586|
71722224|NCT03818607|142961108|OTHER||GMR|0.9508|||||TWO_SIDED|90.0|0.7454|1.213||||||Unbound PK AUC GMR (ABP 959/Eculizumab)||1.2130|0.7454|
71722225|NCT05059301|142961115|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 2) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|1.06|||||TWO_SIDED|95.0|0.94|1.21||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 2 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.21|0.94|
71722226|NCT05059301|142961115|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 1 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.04||||||To demonstrate the clinical equivalence of RSV OA\_Lot 1 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||1.04|0.81|
71722227|NCT05059301|142961115|EQUIVALENCE|Clinical equivalence is demonstrated if the 2 sided 95% CI of the GMC ratios (RSV OA\_Lot 2 divided by RSV OA\_Lot 3) is within the pre defined limit of \[0.67, 1.5\].|Adjusted group GMC ratio|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||To demonstrate the clinical equivalence of RSV OA\_Lot 2 versus RSV OA\_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or \>=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.||0.99|0.77|
71722228|NCT03249909|142961161|NON_INFERIORITY|Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups with the two-sided Sign test on the Intent To Treat (ITT) population at 95% confidence interval.||||||0.0019|||||||Sign test|||||||0.0019
71829779|NCT03622593|143163805|OTHER||Difference in CMH Weighted Percentage|0.2|||||TWO_SIDED|95.0|-4.8|5.2||||||This is the difference in percentage of participants gaining ≥0 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||5.2|-4.8|
71829780|NCT03622593|143163810|OTHER||Difference in CMH Weighted Percentage|0.3|||||TWO_SIDED|95.0|-1.6|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-1.6|
71829781|NCT03622593|143163810|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-1.8|
71829782|NCT03622593|143163810|OTHER||Difference in CMH Weighted Percentage|-0.1|||||TWO_SIDED|95.0|-2.3|2.1||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.1|-2.3|
71722229|NCT01153711|142961193|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|168.4|STANDARD_DEVIATION|16.4||1|TWO_SIDED|90.0|155.5|182.4||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||182.4|155.5|1.0000
71722230|NCT01153711|142961194|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|166.1|STANDARD_DEVIATION|16.8||1|TWO_SIDED|90.0|153.6|179.6||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||179.6|153.6|1.0000
71722231|NCT01153711|142961194|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|106.63|STANDARD_DEVIATION|14.7||0.0001|TWO_SIDED|90.0|100.211|113.463||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||113.463|100.211|0.0001
71722232|NCT01153711|142961197|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|144.23|STANDARD_DEVIATION|17.8||0.9986|TWO_SIDED|90.0|133.853|155.417||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol||155.417|133.853|0.9986
71722233|NCT01153711|142961197|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|132.87|STANDARD_DEVIATION|18.9||0.8991|TWO_SIDED|90.0|122.732|143.843||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide||143.843|122.732|0.8991
71722234|NCT01153711|142961198|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|100.75|STANDARD_DEVIATION|17.9||0.0001|TWO_SIDED|90.0|92.534|109.692||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol||109.692|92.534|0.0001
71722235|NCT01178944|142961210|OTHER||Mean Difference (Final Values)|1.08||||0.585|TWO_SIDED|95.0|0.78|1.38|||t-test, 2 sided|||Comparison is CR+PR vs stable disease/progression||1.38|0.78|0.585
71722236|NCT03206918|142961237|SUPERIORITY||2-side Clopper-Pearson|87.9|||<|0.0001|TWO_SIDED|95.0|79.4|93.81|||Exact Binomial Test|The null hypothesis is ORR = 32%||||93.81|79.40|<0.0001
71722237|NCT03823287|142961243|NON_INFERIORITY|If the lower bound of a two-sided 95.03% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.|Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.1|2.5|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \>-4 letters. A sample size of approximately 320 participants in each arm provided greater than 90% power to show non-inferiority of faricimab to aflibercept in the change from baseline BCVA averaged over Weeks 40, 44, and 48 in the ITT population, using a non-inferiority margin of 4 letters at the one-sided 0.02485 significance level.||2.5|-1.1|
71722238|NCT03823287|142961244|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-1.2|2.7|||||The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||2.7|-1.2|
71722239|NCT03823287|142961246|OTHER||Difference in CMH Weighted Percentage|4.3|||||TWO_SIDED|95.0|-1.6|10.1|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥15 Letters: Treatment Difference at Weeks 40-48||10.1|-1.6|
71722240|NCT03823287|142961246|OTHER||Difference in CMH Weighted Percentage|5.4|||||TWO_SIDED|95.0|-2.0|12.7|||||The treatment difference in CMH weighted percentage of participants gaining ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥10 Letters: Treatment Difference at Weeks 40-48||12.7|-2.0|
71722241|NCT03823287|142961246|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-6.6|8.9|||||The treatment difference in CMH weighted percentage of participants gaining ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥5 Letters: Treatment Difference at Weeks 40-48||8.9|-6.6|
71722242|NCT03823287|142961246|OTHER||Difference in CMH Weighted Percentage|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The treatment difference in CMH weighted percentage of participants gaining ≥0 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Gaining ≥0 Letters: Treatment Difference at Weeks 40-48||5.4|-7.9|
71722243|NCT03823287|142961247|OTHER||Difference in CMH Weighted Percentage|2.7|||||TWO_SIDED|95.0|-3.2|8.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||8.5|-3.2|
71722244|NCT03823287|142961252|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.2|4.8|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥15 Letters: Treatment Difference at Weeks 40-48||4.8|-2.2|
71722245|NCT03823287|142961252|OTHER||Difference in CMH Weighted Percentage|-0.4|||||TWO_SIDED|95.0|-4.6|3.9|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥10 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥10 Letters: Treatment Difference at Weeks 40-48||3.9|-4.6|
71722246|NCT03823287|142961252|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-4.0|6.4|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥5 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Avoiding a Loss of ≥5 Letters: Treatment Difference at Weeks 40-48||6.4|-4.0|
71829783|NCT03622593|143163810|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.4|1.9||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||1.9|-2.4|
71722247|NCT03823287|142961253|OTHER||Difference in CMH Weighted Percentage|-0.2|||||TWO_SIDED|95.0|-3.9|3.6|||||The treatment difference in CMH weighted percentage of participants avoiding a loss of ≥15 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 52-60||3.6|-3.9|
71722248|NCT03823287|142961257|OTHER||Difference in CMH Weighted Percentage|3.0|||||TWO_SIDED|95.0|-3.6|9.5|||||The treatment difference in CMH weighted percentage of participants gaining ≥15 letters or achieving BCVA ≥84 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||9.5|-3.6|
71722249|NCT03823287|142961259|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-7.7|6.6|||||The treatment difference in CMH weighted percentage of participants achieving BCVA ≥69 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||6.6|-7.7|
71722250|NCT03823287|142961261|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-4.2|3.3|||||The treatment difference in CMH weighted percentage of participants with BCVA ≤38 letters is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept.|Treatment Difference in CMH Weighted Percentages at Weeks 40-48||3.3|-4.2|
71722251|NCT03823287|142961269|OTHER||Adjusted mean difference|-7.4|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-15.7|0.8|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 40-48||0.8|-15.7|
71887725|NCT02531646|143296669|SUPERIORITY_OR_OTHER|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided|||||||0.000
71887726|NCT01916980|143296702|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis group||||<0.001
71722252|NCT03823287|142961270|OTHER||Adjusted mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.26|||TWO_SIDED|95.0|-7.4|9.4|||||The treatment difference in adjusted means of change from baseline CST is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.|Treatment Difference in Adjusted Means at Weeks 52-60||9.4|-7.4|
71722253|NCT03304054|142961315|OTHER|||||||0.2196||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.2196
71722254|NCT03304054|142961316|OTHER|||||||0.3736||||||P-value for Wilcoxon-Mann-Whitney Test of Equality of change from baseline distributions between the amifampridine phosphate and placebo treatment groups.|Wilcoxon (Mann-Whitney)|||A Wilcoxon-Mann-Whitney Rank Sum Test of equality of change from baseline distributions between subjects diagnosed with MuSK-MG treated with amifampridine and placebo was conducted.||||0.3736
71887727|NCT01916980|143296702|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus group||||<0.001
71887728|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8127|TWO_SIDED|95.0|0.63|1.8||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||bFGF (high versus low)||1.80|0.63|0.8127
71887729|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0285|TWO_SIDED|95.0|1.06|3.08||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||E-selectin (high versus low)||3.08|1.06|0.0285
71887730|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.7478|TWO_SIDED|95.0|0.64|1.85||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||ICAM (high versus low)||1.85|0.64|0.7478
71722255|NCT00335283|142961502|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.12||||0.01|TWO_SIDED|95.0|1.28|7.59|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||7.59|1.28|.01
71722256|NCT00335283|142961502|SUPERIORITY_OR_OTHER||Odds Ratio, log|3.5||||0.006|TWO_SIDED|95.0|1.41|8.67|||Regression, Logistic|||This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||8.67|1.41|.006
71722257|NCT00335283|142961503|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.01||||0.97|TWO_SIDED|95.0|0.38|2.7|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||2.70|0.38|.97
71722258|NCT00335283|142961503|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.11||||0.84|TWO_SIDED|95.0|0.4|3.06|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||3.06|0.40|.84
71722259|NCT00335283|142961504|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.44||||0.06|TWO_SIDED|95.0|0.95|6.31|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||6.31|.95|.06
71722260|NCT00335283|142961504|SUPERIORITY_OR_OTHER||Odds Ratio, log|4.51||||0.007|TWO_SIDED|95.0|1.5|13.6|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.6|1.5|.007
71722261|NCT00335283|142961505|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.17||||0.006|TWO_SIDED|95.0|2.02|13.2|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||13.2|2.02|.006
71722262|NCT00335283|142961505|SUPERIORITY_OR_OTHER||Odds Ratio, log|5.31||||0.001|TWO_SIDED|95.0|1.97|14.3|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.||14.3|1.97|.001
71722263|NCT03086408|142961549|OTHER||Mean Difference (Final Values)|-4.0||||0.09|TWO_SIDED|95.0|-9.0|1.0|||t-test, 2 sided|||||1.00|-9.00|0.09
71722264|NCT03086408|142961550|OTHER||Mean Difference (Final Values)|0.9||||0.61|TWO_SIDED|95.0|-2.89|4.69|||t-test, 2 sided|||||4.69|-2.89|0.61
71722265|NCT03086408|142961551|OTHER||Mean Difference (Final Values)|-0.07||||0.78|TWO_SIDED|95.0|-0.61|0.47|||t-test, 2 sided|||||0.47|-0.61|0.78
71722266|NCT03086408|142961552|OTHER||Mean Difference (Final Values)|-0.4||||0.3|TWO_SIDED|95.0|-1.3|0.5|||t-test, 2 sided|||||0.50|-1.30|0.30
71722267|NCT03086408|142961553|OTHER||Mean Difference (Final Values)|0.1||||0.98|TWO_SIDED|95.0|-8.62|8.82|||t-test, 2 sided|||||8.82|-8.62|0.98
71769393|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|9.0|||||TWO_SIDED|95.0|4.9|13.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.6|4.9|
71769394|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.2|9.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.7|1.2|
71769395|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|15.0|||||TWO_SIDED|95.0|7.5|22.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||22.6|7.5|
71769396|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-6.8|10.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.0|-6.8|
71769397|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-9.8|15.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|-9.8|
71829784|NCT03622593|143163810|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-1.9|4.5||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.5|-1.9|
71722268|NCT03086408|142961554|OTHER||Mean Difference (Final Values)|0.6||||0.61|TWO_SIDED|95.0|-1.64|2.84|||t-test, 2 sided|||||2.84|-1.64|0.61
71722269|NCT03086408|142961555|OTHER||Mean Difference (Final Values)|13.7||||0.04|TWO_SIDED|95.0|0.63|26.77|||t-test, 2 sided|||||26.77|0.63|0.04
71722270|NCT03086408|142961556|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-2.8|2.8|||t-test, 2 sided|||||2.80|-2.80|1
71722271|NCT03086408|142961557|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-2.38|1.98|||t-test, 2 sided|||||1.98|-2.38|0.82
71722272|NCT03086408|142961558|OTHER||Mean Difference (Final Values)|-1.5||||0.37|TWO_SIDED|95.0|-5.29|2.29|||t-test, 2 sided|||||2.29|-5.29|0.37
71722273|NCT03367403|142961559|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.56||0.042|TWO_SIDED|95.0|0.12|6.27|||Mixed Models Analysis|||||6.27|0.12|0.042
71829785|NCT03622593|143163810|OTHER||Difference in CMH Weighted Percentage|1.6|||||TWO_SIDED|95.0|-1.5|4.6||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.6|-1.5|
71829786|NCT03622593|143163814|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.3|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.3|
71829787|NCT03622593|143163814|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-2.0|2.2||||||This is the difference in percentage of participants avoiding a loss of ≥15 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.2|-2.0|
71829788|NCT03622593|143163814|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|-2.7|2.6||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||2.6|-2.7|
71829789|NCT03622593|143163814|OTHER||Difference in CMH Weighted Percentage|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||This is the difference in percentage of participants avoiding a loss of ≥10 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||2.3|-2.9|
71829790|NCT03622593|143163814|OTHER||Difference in CMH Weighted Percentage|1.3|||||TWO_SIDED|95.0|-2.0|4.7||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W.||4.7|-2.0|
71829791|NCT03622593|143163814|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-2.1|4.4||||||This is the difference in percentage of participants avoiding a loss of ≥5 letters in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W.||4.4|-2.1|
71722274|NCT03367403|142961560|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.898||0.04|TWO_SIDED|95.0|-3.63|-0.09|||Mixed Models Analysis|||||-0.09|-3.63|0.040
71722275|NCT03367403|142961561|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.239||0.139|TWO_SIDED|95.0|-0.83|0.12|||Mixed Models Analysis|||||0.12|-0.83|0.139
71722276|NCT03367403|142961562|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.525||0.227|TWO_SIDED|95.0|-0.4|1.67|||Mixed Models Analysis|||||1.67|-0.40|0.227
71722277|NCT03367403|142961563|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|1.009||0.23|TWO_SIDED|95.0|-0.77|3.2|||Mixed Models Analysis|||||3.20|-0.77|0.230
71722278|NCT03367403|142961564|SUPERIORITY||Mean Difference (Final Values)|-85.06|STANDARD_ERROR_OF_MEAN|3.867|<|0.001|TWO_SIDED|95.0|-92.68|-77.43|||Mixed Models Analysis|||||-77.43|-92.68|<0.001
71722279|NCT03367403|142961565|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.56|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Tau-IQ||0.03|-0.01|0.560
71722280|NCT03367403|142961565|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.012|TWO_SIDED|95.0|0.007|0.062|||ANCOVA|||MUBADA-Cerebellum||0.062|0.007|0.012
71722281|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-2.67|STANDARD_ERROR_OF_MEAN|0.631|<|0.001|TWO_SIDED|95.0|-3.92|-1.43|||Mixed Models Analysis|||Bilateral Cortical||-1.43|-3.92|< 0.001
71722282|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.011||0.916|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||Bilateral Entorhinal Cortex||0.02|-0.02|0.916
71722283|NCT03367403|142961566|SUPERIORITY|Bilateral Hippocampus|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.019||0.771|TWO_SIDED|95.0|-0.03|0.04|||Mixed Models Analysis|||||0.04|-0.03|0.771
71722284|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.047||0.094|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||Bilateral Inferior Parietal Lobe||0.01|-0.17|0.094
71722285|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.052|TWO_SIDED|95.0|-0.04|0.0|||Mixed Models Analysis|||Bilateral Isthmuscingulate||0.00|-0.04|0.052
71722286|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.005|TWO_SIDED|95.0|-0.57|-0.11|||Mixed Models Analysis|||Bilateral Lateral Parietal Lobe||-0.11|-0.57|0.005
71722287|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.036||0.731|TWO_SIDED|95.0|-0.08|0.06|||Mixed Models Analysis|||Bilateral Medial Temporal Lobe||0.06|-0.08|0.731
71722288|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.046|<|0.001|TWO_SIDED|95.0|-0.25|-0.07|||Mixed Models Analysis|||Bilateral Precuneus||-0.07|-0.25|<0.001
71722289|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.114|<|0.001|TWO_SIDED|95.0|-0.62|-0.17|||Mixed Models Analysis|||Bilateral Prefrontal Lobe||-0.17|-0.62|<0.001
71722290|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Models Analysis|||Bilateral Superior Temporal Lobe||-0.12|-0.30|<0.001
71722291|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|2.28|STANDARD_ERROR_OF_MEAN|0.581|<|0.001|TWO_SIDED|95.0|1.14|3.43|||Mixed Models Analysis|||Bilateral Ventricles||3.43|1.14|< 0.001
71722292|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.519||0.003|TWO_SIDED|95.0|-7.58|-1.59|||Mixed Models Analysis|||Bilateral Whole Brain||-1.59|-7.58|0.003
71722293|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.03|-0.33|||Mixed Models Analysis|||Bilateral Whole Temporal Lobe||-0.33|-1.03|<0.001
71722294|NCT03367403|142961566|SUPERIORITY||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|0.987||0.022|TWO_SIDED|95.0|-4.23|-0.33|||Mixed Models Analysis|||Bilateral White Matter||-0.33|-4.23|0.022
71722295|NCT03470194|142961575|OTHER||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||||||=0.002
71722296|NCT00758069|142961596|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-25.9|||<|0.001||95.0|-34.2|-17.5||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-17.5|-34.2|<0.001
71829792|NCT03622593|143163818|OTHER||Difference in CMH Weighted Percentage|4.8|||||TWO_SIDED|95.0|-3.1|12.7||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||12.7|-3.1|
71829793|NCT03622593|143163818|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-8.8|6.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||6.2|-8.8|
71722297|NCT00758069|142961596|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.5|||<|0.001||95.0|-28.0|-11.1||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.1|-28.0|<0.001
71722298|NCT00758069|142961597|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-19.3|||<|0.001||95.0|-26.6|-11.9||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-11.9|-26.6|<0.001
71829794|NCT03622593|143163818|OTHER||Difference in CMH Weighted Percentage|2.6|||||TWO_SIDED|95.0|-6.5|11.6||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||11.6|-6.5|
71722299|NCT00758069|142961597|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-12.9|||<|0.001||95.0|-20.4|-5.4||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval|||-5.4|-20.4|<0.001
71722300|NCT02027311|142961638|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0||||For two-sided tests, p \< 0.05 was considered statistically significant.|Regression, Logistic|Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).||If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.05
71722301|NCT02027311|142961639|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.09||||0.002|TWO_SIDED|95.0|2.41|50.94||Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).|Regression, Logistic|||All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p \< 0.05 was considered statistically significant.||50.94|2.41|0.002
71722302|NCT01825512|142961640|NON_INFERIORITY|Deferiprone was declared non inferior to Deferasirox if the lower limit of the 95% confidence interval for the difference in the proportion of successful chelation in the two groups is above -12.5%.|Treatment success rate|-12.5|||||ONE_SIDED|95.0|-12.5||||||||||-12.5|
71722303|NCT01825512|142961641|OTHER|GLM model|Mean Difference (Final Values)|2.128|STANDARD_ERROR_OF_MEAN|1.18||0.074|TWO_SIDED|95.0|-0.213|4.468|||ANCOVA|||||4.468|-0.213|0.074
71722304|NCT01825512|142961642|OTHER|GLM Analysis|Mean Difference (Final Values)|-0.633|STANDARD_ERROR_OF_MEAN|1.741||0.717|TWO_SIDED|95.0|-4.085|2.819|||ANCOVA|||||2.819|-4.085|0.717
71887731|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6761|TWO_SIDED|95.0|0.58|2.33||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||PlGF (high versus low)||2.33|0.58|0.6761
71887732|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4601|TWO_SIDED|95.0|0.72|2.09||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGF A (high versus low)||2.09|0.72|0.4601
71887733|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.3193|TWO_SIDED|95.0|0.46|1.29||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-1 (high versus low)||1.29|0.46|0.3193
71722305|NCT01825512|142961643|NON_INFERIORITY|Non inferiority of Deferiprone to Deferasirox is tested considering a non-inferiority margin of 400 ng/mL.|Mean Difference (Final Values)|0.601|STANDARD_ERROR_OF_MEAN|164.734||0.997|TWO_SIDED|95.0|-323.58|324.781|||GLM|||||324.781|-323.580|0.997
71722306|NCT02466425|142961644|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-13.0|-6.8|||Mixed-effects model for repeated measure||Between treatment groups|||-6.8|-13.0|<0.001
71722307|NCT03231917|142961670|OTHER|||||||0.48|||||||Chi-squared|||||||0.48
71769398|NCT02446743|143039179|OTHER|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.8|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||14.7|-7.8|
71769399|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group ratio of GMTs|2.54|||||TWO_SIDED|95.0|2.07|3.12|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.12|2.07|
71769400|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|2.13|||||TWO_SIDED|95.0|1.66|2.72|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.72|1.66|
71769401|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|2.96|||||TWO_SIDED|95.0|2.15|4.07|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.07|2.15|
71769402|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||21|12|
71887734|NCT00700180|143296729|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.1758|TWO_SIDED|95.0|0.85|2.45||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-2 (high versus low)||2.45|0.85|0.1758
71887735|NCT00700180|143296731|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9454|TWO_SIDED|95.0|0.78|1.31|||Log Rank|||||1.31|0.78|0.9454
71722308|NCT01901289|142961687|OTHER||Cumulative Probability|0.927|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.881|0.956|||||The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|||0.956|0.881|
71887736|NCT00700180|143296732|SUPERIORITY_OR_OTHER||Difference in Responses Rates|9.34||||0.1737|TWO_SIDED|95.0|-2.4|21.0|||Cochran-Mantel-Haenszel||Approximate 95% Confidence Interval (CI) for difference of two rates using Hauck-Anderson method.|||21.0|-2.4|0.1737
71722309|NCT01813058|142961688|SUPERIORITY||Mean Difference (Final Values)|195.0|||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71722310|NCT00182078|142961691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_DEVIATION|3.4|=|0.017|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.017
71722311|NCT00182078|142961692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.9|<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
71722312|NCT00182078|142961693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|4.4|=|0.65|TWO_SIDED|95.0|||||t-test, 2 sided|||||||=0.65
71722313|NCT00893152|142961732|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71722314|NCT00744380|142961797|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71722315|NCT00744380|142961798|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||For open label midazolam||||0.25
71722316|NCT00744380|142961798|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||For all midazolam||||0.048
71722317|NCT00744380|142961798|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||For fentanyl||||0.88
71887737|NCT00700180|143296733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.6148|TWO_SIDED|95.0|-8.2|11.7|||Cochran-Mantel-Haenszel||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||11.7|-8.2|0.6148
71887738|NCT00700180|143296735|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.7587|TWO_SIDED|95.0|0.68|1.69|||Log Rank|||||1.69|0.68|0.7587
71722318|NCT00744380|142961799|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||For Riker scores||||0.75
71722319|NCT00744380|142961799|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||For pain scores||||0.17
71769403|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|20.0|||||TWO_SIDED|95.0|14.0|28.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||28|14|
71769404|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|14.0|||||TWO_SIDED|95.0|9.05|20.0|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||20|9.05|
71887739|NCT00700180|143296737|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.312|TWO_SIDED|95.0|0.87|1.53|||Log Rank|||||1.53|0.87|0.3120
71887740|NCT01872338|143296738|SUPERIORITY||Incident Rate Ratio|0.5||||0.015|TWO_SIDED|95.0|0.29|0.87|||negative binomial regression|||||.87|.29|.015
71722320|NCT00744380|142961800|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For hypotension||||>0.1
71722321|NCT00744380|142961800|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Chi-squared, Corrected|||For bradycardia||||>0.1
71722322|NCT00744380|142961800|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Fisher Exact|||For tachycardia||||>0.1
71722323|NCT00744380|142961800|SUPERIORITY_OR_OTHER|||||||0.07|||||||Fisher Exact|||For delirium, new onset||||0.07
71722324|NCT00744380|142961801|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Median number of experiences remembered||||0.015
71722325|NCT00744380|142961802|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71722326|NCT00744380|142961803|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
71722327|NCT00744380|142961804|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For anxiety||||>0.1
71722328|NCT00744380|142961804|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 2 sided|||For depression||||>0.1
71722329|NCT02443116|142961805|SUPERIORITY||Difference in least squares means|-8.84|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|96.0|-12.09|-5.59||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-5.59|-12.09|<0.001
71722330|NCT02443116|142961805|SUPERIORITY||Difference in least squares means|-11.06|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|96.0|-14.39|-7.74||p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.|t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-7.74|-14.39|<0.001
71722331|NCT02443116|142961805|SUPERIORITY||Difference in least squares means|-2.22|STANDARD_ERROR_OF_MEAN|1.38||0.112|TWO_SIDED|96.0|-5.11|0.67|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||0.67|-5.11|0.112
71722332|NCT02443116|142961806|SUPERIORITY||Difference in least squares means|-5.73|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-8.48|-2.99|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-2.99|-8.48|<0.0001
71887741|NCT01872338|143296739|SUPERIORITY||Incident Rate Ratio|0.43||||0.01|TWO_SIDED|95.0|0.22|0.82|||negative binomial regression|||||.82|.22|.01
71887742|NCT01872338|143296740|SUPERIORITY|||||||0.34|||||||Regression, Linear|repeated measures, overall time by condition effect||||||.34
71887743|NCT01872338|143296741|SUPERIORITY|||||||0.23||||||repeated measures, overall time by condition effect|Regression, Linear|||||||.23
71722333|NCT02443116|142961806|SUPERIORITY||Difference in least squares means|-6.6|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-9.41|-3.79|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.79|-9.41|<0.0001
71722334|NCT02443116|142961806|SUPERIORITY||Difference in least squares means|-0.87|STANDARD_ERROR_OF_MEAN|1.43||0.5467|TWO_SIDED|95.0|-3.71|1.98|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||1.98|-3.71|0.5467
71722335|NCT02443116|142961806|SUPERIORITY||Difference in least squares means|-5.9|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.55|-3.25|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-3.25|-8.55|<0.0001
71722336|NCT02443116|142961806|SUPERIORITY||Difference in least squares means|-0.17|STANDARD_ERROR_OF_MEAN|1.37||0.9037|TWO_SIDED|95.0|-2.89|2.55|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||2.55|-2.89|0.9037
71722337|NCT02443116|142961806|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|1.38||0.6134|TWO_SIDED|95.0|-2.05|3.45|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||3.45|-2.05|0.6134
71722338|NCT02443116|142961807|SUPERIORITY||Difference in least squares means|-4.97|STANDARD_ERROR_OF_MEAN|1.53||0.0018|TWO_SIDED|95.0|-8.03|-1.91|||t-test, 2 sided|||The absolute change in liver fat content from baseline to Week 12 was compared between treatment groups using an ANCOVA model with treatment group and diabetic status as cofactors and baseline endpoint and baseline alanine aminotransferase (ALT) as covariates.||-1.91|-8.03|0.0018
71722339|NCT01932372|142961814|OTHER||Incidence rate ratio (unadjusted)|4.85|||||TWO_SIDED|95.0|3.34|7.03||||||||7.03|3.34|
71722340|NCT01932372|142961814|OTHER||Hazard ratio (unadjusted)|4.8|||||TWO_SIDED|95.0|3.31|6.96||||||||6.96|3.31|
71722341|NCT01932372|142961814|OTHER||Hazard ratio (adjusted 1)|2.07|||||TWO_SIDED|95.0|0.95|4.51||||||||4.51|0.95|
71722342|NCT01932372|142961814|OTHER||Hazard ratio (adjusted 2)|3.81|||||TWO_SIDED|95.0|2.24|6.47||||||||6.47|2.24|
71722343|NCT01932372|142961814|OTHER||Hazard ratio (adjusted 3)|3.55|||||TWO_SIDED|95.0|2.08|6.09||||||||6.09|2.08|
71722344|NCT01932372|142961814|OTHER||Hazard ratio (adjusted 4)|3.8|||||TWO_SIDED|95.0|2.31|6.25||||||||6.25|2.31|
71722345|NCT01932372|142961815|OTHER||Incidence rate ratio (unadjusted)|1.6|||||TWO_SIDED|95.0|1.16|2.19||||||||2.19|1.16|
71722346|NCT01932372|142961815|OTHER||Hazard ratio (unadjusted)|1.55|||||TWO_SIDED|95.0|1.12|2.13||||||||2.13|1.12|
71887744|NCT03683394|143296743|SUPERIORITY||Mean Difference (Net)|0.15||||0.008|TWO_SIDED|95.0|0.04|0.26||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.26|0.04|0.008
71722347|NCT01932372|142961815|OTHER||Hazard ratio (adjusted 1)|1.86|||||TWO_SIDED|95.0|1.16|2.99||||||||2.99|1.16|
71887745|NCT03683394|143296744|SUPERIORITY||Mean Difference (Net)|0.11||||0.002|TWO_SIDED|95.0|0.02|0.21||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||0.21|0.02|0.002
71722348|NCT01932372|142961815|OTHER||Hazard ratio (adjusted 2)|1.61|||||TWO_SIDED|95.0|1.06|2.43||||||||2.43|1.06|
71722349|NCT01932372|142961815|OTHER||Hazard ratio (adjusted 3)|1.53|||||TWO_SIDED|95.0|1.0|2.35||||||||2.35|1.00|
71722350|NCT01932372|142961815|OTHER||Hazard ratio (adjusted 4)|1.51|||||TWO_SIDED|95.0|1.03|2.22||||||||2.22|1.03|
71722351|NCT01932372|142961816|OTHER||Mortality rate ratio (unadjusted)|3.39|||||TWO_SIDED|95.0|1.99|5.78||||||||5.78|1.99|
71722352|NCT01932372|142961816|OTHER||Hazard ratio (unadjusted)|3.29|||||TWO_SIDED|95.0|1.93|5.61||||||||5.61|1.93|
71722353|NCT00810771|142961824|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|||||||0.873
71722354|NCT00810771|142961825|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Chi-squared|||||||0.671
71722355|NCT00810771|142961826|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
71722356|NCT00810771|142961827|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Chi-squared|||||||0.186
71722357|NCT00810771|142961828|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Chi-squared|||||||0.576
71722358|NCT00810771|142961829|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
71722359|NCT02285023|142961830|NON_INFERIORITY_OR_EQUIVALENCE|Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|||||<|0.01||||||An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5|exploratory factor analysis|An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5||Exploratory factor analysis||||<0.01
71722360|NCT02285023|142961831|SUPERIORITY_OR_OTHER||Cronbach's alpha|0.94|||<|0.05|TWO_SIDED||||||Crohbach's alpha|||||||<0.05
71722361|NCT02059499|142961861|SUPERIORITY|||||||0.1877||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1877
71722362|NCT02059499|142961862|SUPERIORITY|||||||0.1068||||||A priori threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.1068
71722363|NCT02059499|142961863|SUPERIORITY|||||||0.8071||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.8071
71722364|NCT02059499|142961864|SUPERIORITY|||||||0.6562||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.6562
71722365|NCT02059499|142961865|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
71722366|NCT02059499|142961866|SUPERIORITY|||||||0.0141||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.0141
71722367|NCT02059499|142961870|SUPERIORITY|||||||0.1409||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.1409
71722368|NCT02059499|142961871|SUPERIORITY|||||||0.0805||||||The threshold for statistical significance was p=0.05|Cochran-Mantel-Haenszel|||||||0.0805
71722369|NCT02059499|142961873|SUPERIORITY|||||||0.5726|||||||Cochran-Mantel-Haenszel|||||||0.5726
71657244|NCT02944383|142831680|SUPERIORITY|||||||0.1222||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||LDL Particles||||0.1222
71722370|NCT02059499|142961874|SUPERIORITY|||||||0.6184||||||The threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||0.6184
71722371|NCT02059499|142961876|EQUIVALENCE|Comparison of mean between count of hrHPV genotypes observed at baseline vs at week 20 in imiquimod arm||||||0.3||||||A priori threshold for interpreting significance : 0.05|Wilcoxon (Mann-Whitney)|||Comparison of number of hrHPV genotypes in each arm observed at baseline vs at week 20 in imiquimod arm||||0.3
71722372|NCT02059499|142961876|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||||0.3||||||A priori threshold to interpret significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in 5FU arm||||0.3
71722373|NCT02059499|142961876|EQUIVALENCE|Comparison of mean number of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||||0.26||||||A priori cutoff of significance: 0.05|Wilcoxon (Mann-Whitney)|||Comparison of the count of hrHPV genotypes observed at baseline vs at week 20 in observation arm||||0.26
71769405|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.26|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|1.26|
71657245|NCT02944383|142831680|SUPERIORITY|||||||0.0734||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.0734
71722374|NCT02374060|142961892|SUPERIORITY||Ratio of the proportion of BL|0.79|||<|0.0001|TWO_SIDED|99.87|0.65|0.96||Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||.96|.65|<0.0001
71722375|NCT02374060|142961892|SUPERIORITY||Ratio of the proportion of BL|0.69|||<|0.0001|TWO_SIDED|99.87|0.56|0.86||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||0.86|0.56|<0.0001
71722376|NCT02374060|142961892|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.88|||||TWO_SIDED|99.87|0.71|1.08|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.08|.71|
71722377|NCT02374060|142961893|SUPERIORITY||Ratio of the proportion of BL|0.95||||0.35|TWO_SIDED|99.87|0.77|1.16||Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||Ratio of intravitreal over periocular|||1.16|0.77|0.35
71722378|NCT02374060|142961893|SUPERIORITY||Ratio of the proportion of BL|0.89||||0.07|TWO_SIDED|99.87|0.72|1.1||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular|||1.10|0.72|0.07
71722379|NCT02374060|142961893|NON_INFERIORITY|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.94|||||TWO_SIDED|99.87|0.77|1.16|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal|||1.16|0.77|
71722380|NCT02374060|142961894|SUPERIORITY||Difference in proportion|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.53|||mixed effects model||Intravitreal - periocular|||0.53|0.24|<0.0001
71722381|NCT02374060|142961894|SUPERIORITY||Difference in proportion|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.59|||mixed effects model||Dexamethasone - periocular|||0.59|0.29|<0.0001
71722382|NCT02374060|142961894|SUPERIORITY||Difference in proportion|0.05||||0.45|TWO_SIDED|95.0|-0.09|0.19|||mixed effects model||Dexamethasone - intravitreal|||0.19|-0.09|0.45
71722383|NCT02374060|142961895|SUPERIORITY||Difference in proportion|0.12||||0.1|TWO_SIDED|95.0|-0.03|0.27|||mixed effects model||Intravitreal - Periocular|||0.27|-0.03|0.10
71722384|NCT02374060|142961895|SUPERIORITY||Difference in proportion|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.28|||mixed effects model||Dexamethasone - Periocular|||0.28|-0.03|0.11
71722385|NCT02374060|142961895|SUPERIORITY||Difference in proportion|0.002||||0.98|TWO_SIDED|95.0|-0.16|0.16|||mixed effects model||Dexamethasone - Intravitreal|||0.16|-0.16|0.98
71722386|NCT02374060|142961896|SUPERIORITY||Difference in proportion|0.27||||0.0005|TWO_SIDED|95.0|0.11|0.43|||mixed effects model||Intravitreal - periocular|||0.43|0.11|0.0005
71722387|NCT02374060|142961896|SUPERIORITY||Difference in proportion|0.4|||<|0.0001|TWO_SIDED|95.0|0.25|0.56|||mixed effects model||Dexamethasone - periocular|||0.56|0.25|<0.0001
71722388|NCT02374060|142961896|SUPERIORITY||Difference in proportion|0.13||||0.12|TWO_SIDED|95.0|-0.04|0.3|||mixed effects model||Dexamethasone - intravitreal|||0.30|-0.04|0.12
71722389|NCT02374060|142961897|SUPERIORITY||Difference in proportion|0.004||||0.96|TWO_SIDED|95.0|-0.16|0.17|||mixed effects model||Intravitreal - periocular|||0.17|-0.16|0.96
71722390|NCT02374060|142961897|SUPERIORITY||Difference in proportion|0.06||||0.51|TWO_SIDED|95.0|-0.11|0.23|||mixed effects model||Dexamethasone - periocular|||0.23|-0.11|0.51
71722391|NCT02374060|142961897|SUPERIORITY||Difference in proportion|0.05||||0.54|TWO_SIDED|95.0|-0.12|0.22|||mixed effects model||Dexamethasone - intravitreal|||0.22|-0.12|0.54
71657246|NCT02944383|142831680|SUPERIORITY|||||||0.421||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||IDL Particles||||0.4210
71657247|NCT02944383|142831681|SUPERIORITY||Median Difference (Net)|0.43||||0.9672|TWO_SIDED|95.0|-8.12|9.07||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||9.07|-8.12|0.9672
71657248|NCT02944383|142831681|SUPERIORITY||Median Difference (Net)|1.58||||0.7993|TWO_SIDED|95.0|-5.31|8.69||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|||8.69|-5.31|0.7993
71657249|NCT02944383|142831682|SUPERIORITY|||||||0.8602||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8602
71657250|NCT02944383|142831682|SUPERIORITY|||||||0.8555||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||||||0.8555
71657251|NCT02944383|142831683|SUPERIORITY|||||||0.0583||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0583
71657252|NCT02944383|142831683|SUPERIORITY|||||||0.2289||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2289
71657253|NCT02944383|142831683|SUPERIORITY|||||||0.0416||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0416
71657254|NCT02944383|142831683|SUPERIORITY|||||||0.015||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0150
71657255|NCT02944383|142831683|SUPERIORITY||Median Difference (Net)|-26.21||||0.0718|TWO_SIDED|95.0|-54.29|-1.26||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-1.26|-54.29|0.0718
71657256|NCT02944383|142831683|SUPERIORITY||Median Difference (Net)|-18.68||||0.1248|TWO_SIDED|95.0|-50.0|7.31||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||7.31|-50.00|0.1248
71657257|NCT02944383|142831684|SUPERIORITY|||||||0.2397||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.2397
71657258|NCT02944383|142831684|SUPERIORITY|||||||0.5399||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5399
71657259|NCT02944383|142831684|SUPERIORITY|||||||0.0409||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0409
71887746|NCT03683394|143296745|SUPERIORITY||Mean Difference (Net)|1.11||||0.03|TWO_SIDED|95.0|0.08|2.14||Adjusted for baseline value, sex, race/ethnicity education, comorbidity score and phone assessment.|Mixed Models Analysis|Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment.||||2.14|0.08|0.03
71657260|NCT02944383|142831684|SUPERIORITY|||||||0.0073||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0073
71657261|NCT02944383|142831684|SUPERIORITY|||||||0.0976||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0976
71722392|NCT02374060|142961898|SUPERIORITY||Difference in mean change from BL|5.32||||0.003|TWO_SIDED|95.0|1.82|8.82|||mixed effects model||Intravitreal - periocular|||8.82|1.82|0.003
71657262|NCT02944383|142831684|SUPERIORITY|||||||0.1899||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1899
71657263|NCT02944383|142831685|SUPERIORITY|||||||0.1747||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1747
71722393|NCT02374060|142961898|SUPERIORITY||Difference in mean change from BL|5.16||||0.004|TWO_SIDED|95.0|1.6|8.72|||mixed effects model||Dexamethasone - periocular|||8.72|1.60|0.004
71722394|NCT02374060|142961898|SUPERIORITY||Difference in mean change from BL|-0.16||||0.93|TWO_SIDED|95.0|-3.67|3.34|||mixed effects model||Dexamethasone - intravitreal|||3.34|-3.67|0.93
71657264|NCT02944383|142831685|SUPERIORITY|||||||0.4576||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4576
71657265|NCT02944383|142831685|SUPERIORITY|||||||0.1549||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1549
71657266|NCT02944383|142831685|SUPERIORITY|||||||0.2427||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2427
71657267|NCT02944383|142831685|SUPERIORITY||Median Difference (Net)|1.51||||0.1379|TWO_SIDED|95.0|-6.26|8.73||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||8.73|-6.26|0.1379
71657268|NCT02944383|142831685|SUPERIORITY||Median Difference (Net)|-6.02||||0.249|TWO_SIDED|95.0|-13.1|0.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||0.51|-13.10|0.2490
71657269|NCT02944383|142831686|SUPERIORITY|||||||0.155||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1550
71657270|NCT02944383|142831686|SUPERIORITY|||||||0.6604||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6604
71657271|NCT02944383|142831686|SUPERIORITY|||||||0.0952||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0952
71657272|NCT02944383|142831686|SUPERIORITY|||||||0.3006||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3006
71657273|NCT02944383|142831686|SUPERIORITY|||||||0.0642||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0642
71657274|NCT02944383|142831686|SUPERIORITY|||||||0.3185||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3185
71657275|NCT02944383|142831687|SUPERIORITY|||||||0.0679||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.0679
71657276|NCT02944383|142831687|SUPERIORITY|||||||0.4126||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.4126
71887747|NCT03683394|143296746|SUPERIORITY||Odds Ratio (OR)|0.68||||0.52|TWO_SIDED|95.0|0.19|2.19||Adjusted for age and sex.|Fisher Exact|In an exploratory outcome, we examined incidence of a low CASI score or a diagnosis of MCI or dementia by treatment group.||||2.19|0.19|0.52
71657277|NCT02944383|142831687|SUPERIORITY|||||||0.0095||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0095
71722395|NCT02374060|142961899|SUPERIORITY||Difference in mean change from BL|5.53||||0.013|TWO_SIDED|95.0|1.14|9.92|||mixed effects model||Intravitreal - periocular|||9.92|1.14|0.013
71722396|NCT02374060|142961899|SUPERIORITY||Difference in mean change from BL|5.14||||0.019|TWO_SIDED|95.0|0.84|9.44|||mixed effects model||Dexamethasone - periocular|||9.44|0.84|0.019
71722397|NCT02374060|142961899|SUPERIORITY||Difference in mean change from BL|-0.4||||0.84|TWO_SIDED|95.0|-4.16|3.37|||mixed effects model||Dexamethasone-intravitreal|||3.37|-4.16|0.84
71722398|NCT02374060|142961903|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.1|TWO_SIDED|95.0|0.09|1.24|||Regression, Cox||Intravitreal/Periocular|||1.24|0.09|0.10
71722399|NCT02374060|142961903|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2|TWO_SIDED|95.0|0.14|1.5|||Regression, Cox||Dexamethasone/Periocular|||1.50|0.14|0.20
71657278|NCT02944383|142831687|SUPERIORITY|||||||0.0172||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0172
71657279|NCT02944383|142831687|SUPERIORITY||Median Difference (Net)|-23.23||||0.0359|TWO_SIDED|95.0|-41.54|-3.64||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||-3.64|-41.54|0.0359
71829795|NCT03622593|143163818|OTHER||Difference in CMH Weighted Percentage|-1.3|||||TWO_SIDED|95.0|-10.0|7.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||7.4|-10.0|
71829796|NCT03622593|143163821|OTHER||Difference in CMH Weighted Percentage|4.7|||||TWO_SIDED|95.0|-2.4|11.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||11.8|-2.4|
71829797|NCT03622593|143163821|OTHER||Difference in CMH Weighted Percentage|2.8|||||TWO_SIDED|95.0|-4.1|9.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||9.8|-4.1|
71657280|NCT02944383|142831687|SUPERIORITY||Median Difference (Net)|-16.06||||0.0812|TWO_SIDED|95.0|-38.62|5.61||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.61|-38.62|0.0812
71657281|NCT02944383|142831688|SUPERIORITY|||||||0.1362||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.1362
71657282|NCT02944383|142831688|SUPERIORITY|||||||0.6458||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.6458
71722400|NCT02374060|142961903|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.62|TWO_SIDED|95.0|0.34|6.26|||Regression, Cox||Dexamethasone/Intravitreal|||6.26|0.34|0.62
71722401|NCT02374060|142961904|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.11|TWO_SIDED|95.0|0.86|4.29|||Regression, Cox||Intravitreal/Periocular|||4.29|0.86|0.11
71722402|NCT02374060|142961904|SUPERIORITY||Hazard Ratio (HR)|2.85||||0.009|TWO_SIDED|95.0|1.3|6.28|||Regression, Cox||Dexamethasone/Intravitreal|||6.28|1.30|0.009
71722403|NCT02374060|142961904|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.3|TWO_SIDED|95.0|0.72|2.81|||Regression, Cox||Dexamethasone/intravitreal|||2.81|0.72|0.30
71722404|NCT02374060|142961905|SUPERIORITY||Hazard Ratio (HR)|1.83||||0.09|TWO_SIDED|95.0|0.91|3.65|||Regression, Cox||Intravitreal/periocular|||3.65|0.91|0.09
71722405|NCT02374060|142961905|SUPERIORITY||Hazard Ratio (HR)|2.52||||0.007|TWO_SIDED|95.0|1.29|4.91|||Regression, Cox||Dexamethasone/periocular|||4.91|1.29|0.007
71722406|NCT02374060|142961905|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.37|TWO_SIDED|95.0|0.72|2.43|||Regression, Cox||Dexamethasone/intravitreal|||2.43|0.72|0.37
71722407|NCT02374060|142961906|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.92|TWO_SIDED|95.0|0.28|4.01|||Regression, Cox||Intravitreal/Periocular|||4.01|0.28|0.92
71722408|NCT02374060|142961906|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.65|TWO_SIDED|95.0|0.16|3.11|||Regression, Cox||Dexamethasone/Periocular|||3.11|0.16|0.65
71722409|NCT02374060|142961906|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.53|TWO_SIDED|95.0|0.16|2.59|||Regression, Cox||Dexamthasone/Intravitreal|||2.59|0.16|0.53
71722410|NCT01751906|142961966|SUPERIORITY|||||||0.9256|||||||Chi-squared|||||||0.9256
71722411|NCT01751906|142961967|SUPERIORITY|||||||0.504|||||||Fisher Exact|||||||0.5040
71722412|NCT01751906|142961968|SUPERIORITY|||||||0.2126|||||||Fisher Exact|||||||0.2126
71657283|NCT02944383|142831688|SUPERIORITY|||||||0.0209||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0209
71722413|NCT01751906|142961995|SUPERIORITY|||||||0.0665|||||||Chi-squared|||||||0.0665
71722414|NCT01460875|142962026|NON_INFERIORITY|The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||.22
71722415|NCT02150057|142962045|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71722416|NCT00394251|142962056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.641
71722417|NCT00394251|142962062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0|||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity||||0.323
71722418|NCT01696994|142962068|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.95|1.04|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.04|0.95|
71722419|NCT01696994|142962070|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.99|1.48|||Poisson regression|||||1.48|0.99|
71722420|NCT01696994|142962080|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.91|1.54||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.54|.91|
71722421|NCT04644276|142962085|SUPERIORITY||Median Difference (Final Values)|-37.0|STANDARD_DEVIATION|102.0||0.8125|TWO_SIDED|95.0|-112.6|140.7|||Wilcoxon Signed-Ranks test||Unit is percent change.|Percent change in leak 100% x (\[Mask with mask adhesive\] - \[Mask without mask adhesive\])/ \[Mask without mask adhesive\]. The comparison between the two arms is captured in the reported percentage change.||140.7|-112.6|0.8125
71722422|NCT01951586|142962103|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5157|TWO_SIDED|95.0|0.81|1.53|||Log Rank|Log rank test stratified by the randomization stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.53|0.81|0.5157
71829798|NCT03622593|143163821|OTHER||Difference in CMH Weighted Percentage|1.5|||||TWO_SIDED|95.0|-6.5|9.4||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.4|-6.5|
71829799|NCT03622593|143163821|OTHER||Difference in CMH Weighted Percentage|1.7|||||TWO_SIDED|95.0|-6.0|9.3||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||9.3|-6.0|
71829800|NCT03622593|143163824|OTHER||Difference in CMH Weighted Percentage|0.1|||||TWO_SIDED|95.0|-1.4|1.5||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.5|-1.4|
71722423|NCT01951586|142962104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3759|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3759
71722424|NCT01951586|142962104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3666|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3666
71722425|NCT01951586|142962104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1917|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1917
71722426|NCT01951586|142962104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3353|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3353
71722427|NCT01951586|142962104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3179|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.3179
71829801|NCT03622593|143163824|OTHER||Difference in CMH Weighted Percentage|-0.7|||||TWO_SIDED|95.0|-1.6|0.2||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.2|-1.6|
71829802|NCT03622593|143163824|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.1|2.1||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.1|-1.1|
71829803|NCT03622593|143163824|OTHER||Difference in CMH Weighted Percentage|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.4|-1.4|
71722428|NCT01951586|142962104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1583|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.1583
71722429|NCT01951586|142962105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3946|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3946
71722430|NCT01951586|142962105|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3735|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.3735
71829804|NCT03622593|143163833|OTHER||Difference in CMH Weighted Percentage|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||1.8|-1.0|
71829805|NCT03622593|143163833|OTHER||Difference in CMH Weighted Percentage|0.5|||||TWO_SIDED|95.0|-1.0|2.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||2.0|-1.0|
71829806|NCT03622593|143163833|OTHER||Difference in CMH Weighted Percentage|0.6|||||TWO_SIDED|95.0|-0.6|1.8||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||1.8|-0.6|
71722431|NCT01951586|142962106|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.3491|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.35|0.43|0.3491
71829807|NCT03622593|143163833|OTHER||Difference in CMH Weighted Percentage|1.2|||||TWO_SIDED|95.0|-0.4|2.8||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||2.8|-0.4|
71829808|NCT03622593|143163834|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
71829809|NCT03622593|143163834|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||0.0|0.0|
71829810|NCT03622593|143163834|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
71829811|NCT03622593|143163834|OTHER||Difference in CMH Weighted Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||0.0|0.0|
71657284|NCT02944383|142831688|SUPERIORITY|||||||0.0822||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0822
71722432|NCT01951586|142962107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4760
71829812|NCT03622593|143163841|OTHER||Adjusted mean difference|-25.7|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-37.4|-14.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-14.0|-37.4|
71829813|NCT03622593|143163841|OTHER||Adjusted mean difference|-17.6|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|95.0|-29.2|-6.0||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the ITT Population.||-6.0|-29.2|
71829814|NCT03622593|143163841|OTHER||Adjusted mean difference|-20.0|STANDARD_ERROR_OF_MEAN|6.59|||TWO_SIDED|95.0|-32.9|-7.0||||||This is the adjusted mean difference for Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-7.0|-32.9|
71829815|NCT03622593|143163841|OTHER||Adjusted mean difference|-14.3|STANDARD_ERROR_OF_MEAN|6.51|||TWO_SIDED|95.0|-27.1|-1.5||||||This is the adjusted mean difference for Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W in the Treatment-Naive Population.||-1.5|-27.1|
71829816|NCT03622593|143163844|OTHER||Difference in CMH Weighted Percentage|12.3|||||TWO_SIDED|95.0|5.7|18.9||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||18.9|5.7|
71829817|NCT03622593|143163844|OTHER||Difference in CMH Weighted Percentage|8.2|||||TWO_SIDED|95.0|1.5|14.9||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the ITT Population.||14.9|1.5|
71829818|NCT03622593|143163844|OTHER||Difference in CMH Weighted Percentage|9.0|||||TWO_SIDED|95.0|1.6|16.3||||||This is the difference in percentage of participants in Arm A: Faricimab 6 mg Q8W minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||16.3|1.6|
71829819|NCT03622593|143163844|OTHER||Difference in CMH Weighted Percentage|6.2|||||TWO_SIDED|95.0|-1.2|13.6||||||This is the difference in percentage of participants in Arm B: Faricimab 6 mg PTI minus Arm C: Aflibercept 2 mg Q8W for the Treatment-Naive Population.||13.6|-1.2|
71829820|NCT02544152|143163861|OTHER||||||=|0.987|||||||Cochran-Mantel-Haenszel|||P-value is from a Cochran-Mantel-Haenszel (CMH) test stratified by sex and baseline stool consistency||||=0.9870
71829821|NCT00516321|143163879|SUPERIORITY_OR_OTHER||Percentage difference in SVR|7.9||||0.0064|TWO_SIDED|95.0|2.4|13.4||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||13.4|2.4|0.0064
71829822|NCT02139046|143163903|SUPERIORITY_OR_OTHER||Difference in Proportions|25.6|||<|0.001|TWO_SIDED|95.0|20.4|30.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the Cui, Hung, and Wang (CHW) Z-test which accounts for the interim analysis.||||30.9|20.4|<0.001
71829823|NCT02139046|143163903|SUPERIORITY_OR_OTHER||Difference in Proportions|49.8|||<|0.001|TWO_SIDED|95.0|43.9|55.8||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||55.8|43.9|<0.001
71829824|NCT02139046|143163903|SUPERIORITY_OR_OTHER||Difference in Proportions|10.2||||0.001|TWO_SIDED|95.0|3.5|17.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||17.0|3.5|0.001
71829825|NCT02139046|143163903|SUPERIORITY_OR_OTHER||Difference in Proportions|7.5||||0.043|TWO_SIDED|95.0|-0.8|15.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||15.9|-0.8|0.043
71829826|NCT02139046|143163904|SUPERIORITY_OR_OTHER||Difference in Proportions|2.1||||0.503|TWO_SIDED|95.0|-4.9|9.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||9.0|-4.9|0.503
71829827|NCT02139046|143163904|SUPERIORITY_OR_OTHER||Difference in Proportions|5.9||||0.064|TWO_SIDED|95.0|-1.2|13.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||13.0|-1.2|0.064
71829828|NCT02139046|143163904|SUPERIORITY_OR_OTHER||Difference in Proportions|1.8||||0.561|TWO_SIDED|95.0|-5.1|8.7||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||8.7|-5.1|0.561
71722433|NCT01951586|142962107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2582|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2582
71722434|NCT01951586|142962107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2230
71722435|NCT01951586|142962107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4329|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.4329
71722436|NCT01951586|142962107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2620
71722437|NCT01951586|142962107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.||||0.2081
71722438|NCT01951586|142962108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4671|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4671
71722439|NCT01951586|142962108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4236|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.||||0.4236
71722440|NCT01951586|142962109|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.46|1.43|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.|||1.43|0.46|0.4654
71722441|NCT01951586|142962110|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05||||0.7363|TWO_SIDED|95.0|0.78|1.43|||Log Rank|Log rank test stratified by the randomized stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio \< 1 favors denosumab."|||1.43|0.78|0.7363
71722442|NCT01667224|142962120|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71722443|NCT01667224|142962121|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71722444|NCT01667224|142962122|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71722445|NCT01667224|142962123|NON_INFERIORITY_OR_EQUIVALENCE|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.||||<0.05
71722446|NCT01822899|142962165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|95.0|0.046|0.113|||ANCOVA|||||0.113|0.046|<0.001
71722447|NCT02752633|142962179|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.||||<.05
71722448|NCT00853242|142962197|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0249
71722449|NCT00853242|142962197|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.0001
71722450|NCT00853242|142962197|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||<0.0001
71722451|NCT00853242|142962198|SUPERIORITY_OR_OTHER|||||||0.2647|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.2647
71722452|NCT00853242|142962198|SUPERIORITY_OR_OTHER|||||||0.7944|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.7944
71722453|NCT00853242|142962198|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.||||0.3724
71722454|NCT01988662|142962284|NON_INFERIORITY_OR_EQUIVALENCE|"H0: There is no difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept.~HA: There is a difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept."|Mean Difference (Net)|62.57|STANDARD_ERROR_OF_MEAN|24.639||0.012|TWO_SIDED|95.0|13.96|111.17|||Mixed Models Analysis|||H0: μR = μA versus HA: μR ≠ μA||111.17|13.96|0.012
71722455|NCT00842153|142962291|SUPERIORITY_OR_OTHER|||||||0.1269||95.0||||P-value for Week 1|Fisher Exact|||||||0.1269
71722456|NCT00842153|142962291|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 2|Chi-squared|||||||<0.0001
71722457|NCT00842153|142962291|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||P-value for Week 4|Chi-squared|||||||0.0015
71722458|NCT00002540|142962308|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36||Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.|Poisson regression|||||1.36|0.87|
71722459|NCT00002540|142962310|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.93|1.0|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.00|0.93|
71722460|NCT00002540|142962312|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|1.07|1.17|||Poisson regression|Two-sided. Not adjusted for multiple comparisons. A-priori threshold for significance 0.05.||||1.17|1.07|
71722461|NCT00002540|142962322|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||Poisson regression|||||1.36|0.87|
71722462|NCT01345929|142962325|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|2.31|14.57||||||||14.57|2.31|
71722463|NCT01345929|142962326|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|1.95|13.97||||||||13.97|1.95|
71722464|NCT01500252|142962337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
71722465|NCT01500252|142962338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||95.0|||||t-test, 2 sided|||||||0.83
71722466|NCT01500252|142962340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
71722467|NCT01500252|142962341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
71722468|NCT01500252|142962342|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
71769406|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.3|||||TWO_SIDED|95.0|1.11|1.51|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.51|1.11|
71829829|NCT02139046|143163904|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.5||||0.869|TWO_SIDED|95.0|-8.0|6.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||6.9|-8.0|0.869
71722469|NCT01500252|142962343|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
71722470|NCT01500252|142962344|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
71722471|NCT01500252|142962345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
71722472|NCT01500252|142962346|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Chi-squared|||||||0.31
71722473|NCT05319600|142962347|SUPERIORITY|treatment group as predictor baseline-residualized week 12 scores in linear regression|Slope|129.2|STANDARD_ERROR_OF_MEAN|73.96|<|0.05|TWO_SIDED|95.0|-22.52|280.98|||Regression, Linear||Control coded as 0 and treatment as 1|||280.98|-22.52|<0.05
71722474|NCT00323960|142962348|SUPERIORITY|||||||0.0228||||||For multiple hypothesis testing, we used Bonferroni's correction (with n=3 posterior comparisons).|Chi-squared|To assess proportions we used the χ² test or Fisher's exact test||We calculated that a sample size of 40 patients would be needed in each study group (total 120 patients) to have 80% power for comparison of combination treatments (prednisone plus methotrexate or prednisone plus ciclosporin) with the reference treatment (prednisone alone).||||0.0228
71722475|NCT00323960|142962349|SUPERIORITY||Relative risk|2.45||||0.012|TWO_SIDED|95.0|1.2|5.0|||Log Rank||RR related to prednisone plus methotrexate arm (group 3) versus prednisone alone (group 1) and prednisone plus ciclosporin (group 2).|We used the Kaplan-Meier method to produce survival curves (groups 1 and 2 versus group 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||5.0|1.2|0.012
71722476|NCT00323960|142962350|SUPERIORITY||Relative risk|1.95||||0.009|TWO_SIDED|95.0|1.2|3.15|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (group 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||3.15|1.2|0.009
71722477|NCT00323960|142962351|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone+methotrexate arm or prednisone+ciclosporin versus prednisone alone.|We used the Kaplan-Meier method to produce survival curves (groups 2 and 3 versus group 1) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
71722478|NCT00323960|142962351|SUPERIORITY||Relative risk|1.65||||0.002|TWO_SIDED|95.0|1.24|2.14|||Log Rank||RR related to prednisone alone (group 1) versus prednisone plus ciclosporin (group 2) and prednisone plus methotrexate arm (group 3).|We used the Kaplan-Meier method to produce survival curves (groups 1 versus groups 2 and 3) and compared them with the Log-Rank test. We judged a p value less than 0·05 significant. We reported in the table the incidence rates with 95% confidence intervals of the 3 groups.||2.14|1.24|0.002
71722479|NCT00361231|142962380|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kaplan-Meier|||||||<0.05
71722480|NCT00361231|142962381|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71722481|NCT01208961|142962388|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|400.36|||<|0.001|TWO_SIDED|90.0|326.87|490.36|||ANOVA|ANOVA on log-trans baseline-adj PK values using sequence, period, and treatments as fixed effects and subject nested within sequence as random effect||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||490.36|326.87|<0.001
71829830|NCT02139046|143163905|SUPERIORITY_OR_OTHER||Difference in Proportions|47.6|||<|0.001|TWO_SIDED|95.0|41.6|53.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||53.6|41.6|<0.001
71829831|NCT02139046|143163905|SUPERIORITY_OR_OTHER||Difference in Proportions|60.5|||<|0.001|TWO_SIDED|95.0|54.6|66.3||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||66.3|54.6|<0.001
71722482|NCT01208961|142962389|SUPERIORITY_OR_OTHER||Ratio of Geometric Mans|649.66|||<|0.01|TWO_SIDED|90.0|511.75|824.75||ANOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors. LSM estimate performed on log-scale|ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||824.75|511.75|<0.01
71722483|NCT01208961|142962390|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|369.66|||<|0.001|TWO_SIDED|90.0|301.74|452.86|||ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.||452.86|301.74|<0.001
71722484|NCT02241733|142962392|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||An independent t-test was completed.||||0.94
71722485|NCT02241733|142962393|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
71722486|NCT02241733|142962394|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71722487|NCT02241733|142962395|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71722488|NCT01866111|142962396|SUPERIORITY||||||<|0.001|||||||ANCOVA|||A step down procedure was used for the primary efficacy analyses to ensure the type one error rate for multiple comparisons was controlled at the 5% level using the following hierarchy: 200 mg vs placebo, 400 mg vs placebo, 100 mg vs placebo, in which a statistically significant difference had to be detected in this order for each subsequent comparison to occur.||||<0.001
71722489|NCT01866111|142962396|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71722490|NCT01866111|142962396|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
71722491|NCT01866111|142962397|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71722492|NCT01866111|142962397|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71722493|NCT01866111|142962397|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
71722494|NCT04576455|142962400|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1757|TWO_SIDED|95.0|0.6|1.1|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.10|0.60|0.1757
71722495|NCT04576455|142962401|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3446|TWO_SIDED|95.0|0.85|1.6|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|||1.60|0.85|0.3446
71722496|NCT04576455|142962402|SUPERIORITY||Odds Ratio (OR)|1.87||||0.1126|TWO_SIDED|95.0|0.86|4.07|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||4.07|0.86|0.1126
71722497|NCT04576455|142962402|SUPERIORITY||Difference in Objective Response Rates|5.35|||||TWO_SIDED|95.0|-1.97|12.78|||||Giredestrant vs. PCET|||12.78|-1.97|
71722498|NCT04576455|142962404|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0289|TWO_SIDED|95.0|1.06|3.04|||Cochran-Mantel-Haenszel||Giredestrant vs. PCET|||3.04|1.06|0.0289
71722499|NCT04576455|142962404|SUPERIORITY||Difference in Clinical Benefit Rates|10.74|||||TWO_SIDED|95.0|0.33|20.86|||||Giredestrant vs. PCET|||20.86|0.33|
71722500|NCT04576455|142962405|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.061|TWO_SIDED|95.0|0.35|1.03|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 mutation detected at baseline||1.03|0.35|0.0610
71722501|NCT04576455|142962405|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5947|TWO_SIDED|95.0|0.54|1.42|||Log Rank|Stratified analysis (strata are: site of disease, prior CDK4/6i treatment, and prior fulvestrant treatment).|Giredestrant vs. PCET|This statistical analysis is done for PFS by ESR1 Mutation not detected at baseline||1.42|0.54|0.5947
71722502|NCT04576455|142962406|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||Giredestrant vs. PCET|||1.40|0.58|
71722503|NCT04576455|142962407|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.12|||||Giredestrant vs. PCET|||1.12|0.49|
71722504|NCT04576455|142962408|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.35|||||Giredestrant vs. PCET|||1.35|0.53|
71722505|NCT04576455|142962409|OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.72|1.69|||||Giredestrant vs. PCET|||1.69|0.72|
71722506|NCT04576455|142962410|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.47|1.18|||||Giredestrant vs. PCET|||1.18|0.47|
71722507|NCT03989349|142962416|OTHER||Strata-adjusted percentage difference|12.2||||0.0006|TWO_SIDED|97.5|4.6|19.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||19.8|4.6|0.0006
71722508|NCT03989349|142962417|OTHER||Strata-adjusted percentage difference|14.9||||0.0008|TWO_SIDED|97.5|5.6|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|5.6|0.0008
71769407|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.7|||||TWO_SIDED|95.0|1.27|2.28|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.28|1.27|
71769408|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group ratio of GMTs|1.26|||||TWO_SIDED|95.0|0.94|1.68|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.68|0.94|
71769409|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|vaccine group ratio of GMTs|1.32|||||TWO_SIDED|95.0|0.85|2.05|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.05|0.85|
71769410|NCT02446743|143039180|OTHER|Vaccine Comparison at Persistence at 4 years/Baseline in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|vaccine group ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.81|1.78|||ANOVA|Adjusted by vaccine group and country||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.78|0.81|
71657285|NCT02944383|142831688|SUPERIORITY|||||||0.0504||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0504
71657286|NCT02944383|142831688|SUPERIORITY|||||||0.1315||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.1315
71657287|NCT02944383|142831689|SUPERIORITY|||||||0.0843||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0843
71657288|NCT02944383|142831689|SUPERIORITY|||||||0.3587||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3587
71657289|NCT02944383|142831689|SUPERIORITY||Median Difference (Net)|12.99||||0.0843|TWO_SIDED|95.0|-0.54|25.51||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.51|-0.54|0.0843
71657290|NCT02944383|142831689|SUPERIORITY||Median Difference (Net)|7.98||||0.3587|TWO_SIDED|95.0|-3.7|21.39||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||21.39|-3.70|0.3587
71657291|NCT02944383|142831690|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.0768
71657292|NCT02944383|142831690|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4346
71769411|NCT02446743|143039185|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|8.0|21.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||21.6|8.0|
71829832|NCT02139046|143163905|SUPERIORITY_OR_OTHER||Difference in Proportions|7.8||||0.036|TWO_SIDED|95.0|-0.5|16.1||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||16.1|-0.5|0.036
71657293|NCT02944383|142831690|SUPERIORITY|||||||0.0768||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.0768
71657294|NCT02944383|142831690|SUPERIORITY|||||||0.4346||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4346
71657295|NCT02944383|142831691|SUPERIORITY|||||||0.5411||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.5411
71722509|NCT03989349|142962418|OTHER||Strata-adjusted percentage difference|12.5||||0.0006|TWO_SIDED|97.5|4.6|20.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||20.3|4.6|0.0006
71769412|NCT02446743|143039185|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|16.0|||||TWO_SIDED|95.0|10.8|23.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||23.1|10.8|
71657296|NCT02944383|142831691|SUPERIORITY|||||||0.2574||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.2574
71722510|NCT03989349|142962419|OTHER||Strata-adjusted percentage difference|16.3||||0.0004|TWO_SIDED|97.5|6.6|26.0||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.0|6.6|0.0004
71722511|NCT03989349|142962420|OTHER||Strata-adjusted percentage difference|23.2|||<|0.0001|TWO_SIDED|97.5|16.1|30.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||30.3|16.1|<0.0001
71769413|NCT02446743|143039185|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||20.1|11.0|
71829833|NCT02139046|143163905|SUPERIORITY_OR_OTHER||Difference in Proportions|3.3||||0.364|TWO_SIDED|95.0|-4.9|11.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.||||11.6|-4.9|0.364
71829834|NCT00186186|143163929|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)|||||||<0.00001
71722512|NCT03989349|142962420|OTHER||Strata-adjusted percentage difference|27.8|||<|0.0001|TWO_SIDED|97.5|21.2|34.5||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using multiple imputation (MI) with missing at random (MAR) assumption.||34.5|21.2|<0.0001
71722513|NCT03989349|142962421|OTHER||Strata-adjusted percentage difference|27.1|||<|0.0001|TWO_SIDED|97.5|17.5|36.6||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level. Participants with missing data were considered non-responders.||36.6|17.5|<0.0001
71722514|NCT03989349|142962421|OTHER||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|97.5|24.5|42.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\].|Cochran-Mantel-Haenszel||The estimates are from 50 complete datasets by MI-MAR assumption.|Nemolizumab 30 mg versus Placebo using MI-MAR assumption.||42.3|24.5|<0.0001
71722515|NCT03989349|142962422|OTHER||Strata-adjusted percentage difference|17.1|||<|0.0001|TWO_SIDED|97.5|10.9|23.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||23.3|10.9|<0.0001
71769414|NCT02446743|143039185|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|54.0|||||TWO_SIDED|95.0|43.0|63.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||63.3|43.0|
71829835|NCT00186186|143163930|SUPERIORITY_OR_OTHER||Percentage|54.0|||||TWO_SIDED|||||||||||||
71829836|NCT01113931|143163931|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.3|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
71829837|NCT01113931|143163934|SUPERIORITY_OR_OTHER||Difference in Percent Cure Rates|0.2|||||TWO_SIDED|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.||5.1|-4.6|
71829838|NCT03959241|143163951|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.001|TWO_SIDED|95.0|0.492|0.835||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of GRFS hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.835|0.492|0.001
71829839|NCT03959241|143163952|SUPERIORITY|||||||0.995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.995
71829840|NCT03959241|143163952|SUPERIORITY|||||||0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups||||0.001
71829841|NCT03959241|143163952|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.879|TWO_SIDED|95.0|0.758|1.267||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups using a Cox regression model for the cause-specific hazard of aGVHD||1.267|0.758|0.879
71829842|NCT03959241|143163952|SUPERIORITY||Hazard Ratio (HR)|0.386||||0.001|TWO_SIDED|95.0|0.215|0.691||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of grade III-IV aGVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies.||0.691|0.215|0.001
71829843|NCT03959241|143163956|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups||||0.005
71829844|NCT03959241|143163956|SUPERIORITY||Hazard Ratio (HR)|0.556||||0.002|TWO_SIDED|95.0|0.381|0.813||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||0.813|0.381|0.002
71829845|NCT03959241|143163959|SUPERIORITY|||||||0.038||||||Statistical significance was determined using a pre-specified threshold of 0.05|Chi-squared|||The null hypothesis is that there is no difference of Immunosuppression-Free Survival between the treatment groups||||0.038
71829846|NCT03959241|143163960|SUPERIORITY|||||||0.032||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Recovery between the treatment groups||||0.032
71829847|NCT03959241|143163961|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 20,000/mm\^3 between the treatment groups||||<0.001
71829848|NCT03959241|143163961|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet Recovery greater than or equal to 50,000/mm\^3 between the treatment groups||||<0.001
71829849|NCT03959241|143163962|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Lymphocyte Recovery between the treatment groups||||<0.001
71829850|NCT03959241|143163963|SUPERIORITY|||||||0.919||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 28 after transplantation between the treatment groups||||0.919
71829851|NCT03959241|143163963|SUPERIORITY|||||||0.198||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference of Donor Cell Engraftment at Day 100 after transplantation between the treatment groups||||0.198
71829852|NCT03959241|143163964|SUPERIORITY|||||||0.67||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 28 after transplantation between the treatment groups||||0.670
71829853|NCT03959241|143163964|SUPERIORITY|||||||0.607||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference of quantitative donor chimerism at Day 100 after transplantation between the treatment groups||||0.607
71829854|NCT03959241|143163965|SUPERIORITY|||||||0.906||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease Relapse between the treatment groups||||0.906
71887748|NCT00236080|143296752|NON_INFERIORITY_OR_EQUIVALENCE|Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.||||||0.1236||||||The p-value of Overall Treatment to Placebo|ANCOVA|This analysis adjusted for the difference among the treatment groups at baseline.||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.||||0.1236
71722516|NCT03989349|142962423|OTHER||Strata-adjusted percentage difference|18.4|||<|0.0001|TWO_SIDED|97.5|11.0|25.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||25.8|11.0|<0.0001
71722517|NCT03989349|142962424|OTHER||Strata-adjusted percentage difference|17.5|||<|0.0001|TWO_SIDED|97.5|10.8|24.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||24.3|10.8|< 0.0001
71722518|NCT03989349|142962425|OTHER||Strata-adjusted percentage difference|21.9|||<|0.0001|TWO_SIDED|97.5|12.5|31.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||31.4|12.5|<0.0001
71722519|NCT03989349|142962426|OTHER||Strata-adjusted percentage difference|20.9|||<|0.0001|TWO_SIDED|97.5|15.6|26.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting the randomized stratification variables (IGA severity and PP NRS).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||26.1|15.6|< 0.0001
71722520|NCT03989349|142962427|OTHER||Strata-adjusted percentage difference|22.5|||<|0.0001|TWO_SIDED|97.5|15.0|29.9||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||29.9|15.0|<0.0001
71722521|NCT03989349|142962428|OTHER||Strata-adjusted percentage difference|13.2|||<|0.0001|TWO_SIDED|97.5|9.0|17.4||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||17.4|9|< 0.0001
71722522|NCT03989349|142962429|OTHER||Strata-adjusted percentage difference|9.9||||0.0001|TWO_SIDED|97.5|5.5|14.3||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||14.3|5.5|0.0001
71722523|NCT03989349|142962430|OTHER||Strata-adjusted percentage difference|15.1|||<|0.0001|TWO_SIDED|97.5|11.0|19.2||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level||19.2|11|< 0.0001
71722524|NCT03989349|142962431|OTHER||Strata-adjusted percentage difference|16.3|||<|0.0001|TWO_SIDED|97.5|10.5|22.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||22.1|10.5|<0.0001
71769415|NCT02446743|143039185|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|22.0|40.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.1|22.0|
71657297|NCT02944383|142831691|SUPERIORITY||Median Difference (Net)|3.11||||0.5411|TWO_SIDED|95.0|-9.59|14.86||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||14.86|-9.59|0.5411
71722525|NCT03989349|142962432|OTHER||Strata-adjusted percentage difference|6.4|||<|0.0001|TWO_SIDED|97.5|3.8|9.1||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\] and PP NRS \[\>=7, \<7\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for the preceding outcome measure was statistically significant at two-sided 2.5% significance level.||9.1|3.8|<0.0001
71722526|NCT03989349|142962433|OTHER||Strata-adjusted percentage difference|8.0||||0.0004|TWO_SIDED|97.5|4.2|11.8||Strata-adjusted p-values were calculated from Cochran-Mantel-Haenszel test adjusting randomized stratification variables (IGA severity \[3=moderate, 4=severe\]).|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was performed sequentially in order the outcome measures were reported and continued when the test for preceding outcome measure was statistically significant at two-sided 2.5% significance level.||11.8|4.2|0.0004
71722527|NCT01352221|142962434|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|ONE_SIDED|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|||1.81|< 0.0001
71722528|NCT01352221|142962438|SUPERIORITY||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|ONE_SIDED|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|||0.82|< 0.0001
71722529|NCT01352221|142962439|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|ONE_SIDED|97.5|1.43|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|ANCOVA||||||1.43|< 0.0001
71722530|NCT01352221|142962450|SUPERIORITY||Mean Difference (Final Values)|2.18|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|ONE_SIDED|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|||1.87|< 0.0001
71722531|NCT01352221|142962451|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|ONE_SIDED|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF Change in Haemoglobin Concentration from Baseline to Week 12|||1.82|< 0.0001
71887749|NCT00236080|143296753|NON_INFERIORITY_OR_EQUIVALENCE|Using the adjusted p value from Tukey's least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.||||||0.0945||||||The p-value of Overall Treatment to Placebo|ANCOVA|||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .||||0.0945
71887750|NCT03213366|143296781|SUPERIORITY||Slope|-0.0095||||0.5783|TWO_SIDED|95.0|-0.04676|0.02776|||Mixed Models Analysis|||At 6 weeks.||0.02776|-0.04676|0.5783
71887751|NCT03213366|143296781|SUPERIORITY||Slope|-0.01692||||0.3185|TWO_SIDED|95.0|-0.05318|0.01933|||Mixed Models Analysis|||At 12 weeks.||0.01933|-0.05318|0.3185
71887752|NCT03213366|143296782|SUPERIORITY||Slope|0.03674||||0.07863|TWO_SIDED|95.0|-0.00516|0.07863|||Mixed Models Analysis|||At 6 weeks.||0.07863|-0.00516|0.07863
71722532|NCT02016716|142962460|NON_INFERIORITY|Non-inferiority was claimed if the lower bound of the 1-sided 97.5% CI (or the lower bound of 2-sided 95% CI) of the mean difference between the 2 romosozumab groups was \> -2.0%.|Least Squares Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.7|||||Based on ANCOVA model adjusting for treatment, and baseline lumbar spine BMD T-score.|The primary hypothesis was that the mean percent change from baseline in lumbar spine BMD at month 6 in participants receiving romosozumab 210 mg QM using the 90 mg/mL concentration would not be inferior to that in participants receiving romosozumab 210 mg QM using the 70 mg/mL concentration.||0.7|-1.5|
71722533|NCT02248649|142962465|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|covariates: baseline age and years of education||||||0.2
71722534|NCT02248649|142962466|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71722535|NCT02248649|142962467|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71722536|NCT00147017|142962507|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71722537|NCT00147017|142962508|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71722538|NCT00147017|142962509|SUPERIORITY|||||||0.05||||||calculated|Kruskal-Wallis|||||||0.05
71722539|NCT01221623|142962513|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||ANOVA|||||||.0059
71722540|NCT01221623|142962514|SUPERIORITY_OR_OTHER|||||||0.0496|TWO_SIDED||||||ANOVA|||||||.0496
71722541|NCT01221623|142962515|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71722542|NCT01221623|142962516|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||ANOVA|||||||.0340
71722543|NCT01221623|142962517|SUPERIORITY_OR_OTHER|||||||0.1168|TWO_SIDED||||||ANOVA|||||||.1168
71722544|NCT01221623|142962518|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANOVA|||||||.0144
71722545|NCT01221623|142962519|SUPERIORITY_OR_OTHER|||||||0.0248|TWO_SIDED||||||ANOVA|||||||.0248
71722546|NCT01221623|142962520|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||ANOVA|||||||.6949
71722547|NCT01221623|142962521|SUPERIORITY_OR_OTHER|||||||0.0249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||.0249
71722548|NCT00661726|142962522|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
71722549|NCT00661726|142962524|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.045
71722550|NCT00661726|142962525|SUPERIORITY_OR_OTHER|||||||0.083||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.083
71722551|NCT00661726|142962526|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.039
71722552|NCT00661726|142962527|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
71722553|NCT00661726|142962528|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
71887753|NCT03213366|143296782|SUPERIORITY||Slope|0.02594||||0.1999|TWO_SIDED|95.0|-0.01648|0.06836|||Mixed Models Analysis|||At 12 weeks.||0.06836|-0.01648|0.1999
71887754|NCT03213366|143296783|SUPERIORITY||Slope|0.000443||||0.8963|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.8963
71887755|NCT03213366|143296783|SUPERIORITY||Slope|0.004308||||0.3229|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks||||0.3229
71887756|NCT03213366|143296784|SUPERIORITY||Slope|0.008705||||0.2433|TWO_SIDED|||||This t-test was for the random effects model not for comparing the difference between the arms.|Mixed Models Analysis|||||||0.2433
71887757|NCT03213366|143296784|SUPERIORITY||Slope|0.01358||||0.0839|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0839
71887758|NCT03213366|143296785|SUPERIORITY||Slope|-0.302||||0.2114|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.2114
71722554|NCT00661726|142962529|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.069
71829855|NCT03959241|143163965|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.947|TWO_SIDED|95.0|0.641|1.515||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease Relapse hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.515|0.641|0.947
71829856|NCT03959241|143163966|SUPERIORITY|||||||0.167||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Treatment-related Mortality between the treatment groups||||0.167
71887759|NCT03213366|143296785|SUPERIORITY||Slope|-0.03149||||0.2141|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.2141
71887760|NCT03213366|143296786|SUPERIORITY||Slope|0.0278||||0.0124|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0124
71887761|NCT03213366|143296786|SUPERIORITY||Slope|0.03052||||0.0022|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0022
71887762|NCT03213366|143296787|SUPERIORITY||Slope|-0.05747||||0.1021|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.1021
71887763|NCT03213366|143296787|SUPERIORITY||Slope|-0.05101||||0.133|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.133
71887764|NCT03213366|143296788|SUPERIORITY||Slope|-0.0209||||0.0818|TWO_SIDED||||||Mixed Models Analysis|||At 6 weeks.||||0.0818
71887765|NCT03213366|143296788|SUPERIORITY||Slope|0.03103||||0.0334|TWO_SIDED||||||Mixed Models Analysis|||At 12 weeks.||||0.0334
71887766|NCT01960855|143296792|OTHER||||||=|0.033|||||||Chi-squared|||||||= 0.033
71887767|NCT01960855|143296792|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
71887768|NCT01960855|143296792|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
71887769|NCT01960855|143296792|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
71887770|NCT01960855|143296793|OTHER||||||=|0.364|||||||Chi-squared|||||||= 0.364
71887771|NCT01960855|143296793|OTHER||||||=|0.014|||||||Chi-squared|||||||= 0.014
71887772|NCT01960855|143296793|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
71887773|NCT01960855|143296793|OTHER||||||=|0.008|||||||Chi-squared|||||||= 0.008
71887774|NCT01960855|143296794|OTHER||||||=|0.093|||||||Chi-squared|||||||= 0.093
71887775|NCT01960855|143296794|OTHER||||||<|0.001|||||||Chi-squared|||||||< 0.001
71887776|NCT01960855|143296794|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
71887777|NCT01960855|143296794|OTHER||||||=|0.004|||||||Chi-squared|||||||= 0.004
71722555|NCT00661726|142962530|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.18
71829857|NCT03959241|143163966|SUPERIORITY||Hazard Ratio (HR)|0.675||||0.133|TWO_SIDED|95.0|0.404|1.127||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Treatment-related Mortality hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.127|0.404|0.133
71887778|NCT01960855|143296795|OTHER||||||=|0.366|||||||Chi-squared|||||||= 0.366
71887779|NCT01960855|143296795|OTHER||||||=|0.17|||||||Chi-squared|||||||= 0.17
71887780|NCT01960855|143296795|OTHER||||||=|0.003|||||||Chi-squared|||||||= 0.003
71887781|NCT01960855|143296795|OTHER||||||=|0.028|||||||Chi-squared|||||||= 0.028
71887782|NCT01960855|143296796|OTHER||||||=|0.126|||||||Chi-squared|||||||= 0.126
71887783|NCT01960855|143296796|OTHER||||||=|0.072|||||||Chi-squared|||||||= 0.072
71887784|NCT01960855|143296796|OTHER||||||=|0.012|||||||Chi-squared|||||||= 0.012
71887785|NCT01960855|143296796|OTHER||||||=|0.021|||||||Chi-squared|||||||= 0.021
71887786|NCT02058147|143296797|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.898|-0.665||Threshold for significance ≤0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.665|-0.898|<0.0001
71887787|NCT02058147|143296797|NON_INFERIORITY_OR_EQUIVALENCE|Predefined non-inferiority margin of 0.3%.|LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|||TWO_SIDED|95.0|-0.384|-0.194|||Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.||-0.194|-0.384|
71887788|NCT02058147|143296797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.384|-0.194||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Test of superiority was also performed as a secondary endpoint according to hierarchical testing procedure. Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction, as a covariate.||-0.194|-0.384|<0.0001
71887789|NCT02058147|143296798|SUPERIORITY_OR_OTHER||Difference in percentage|40.61|||<|0.0001|TWO_SIDED|95.0|33.63|47.59||Threshold for significance ≤0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||47.59|33.63|<0.0001
71887790|NCT02058147|143296798|SUPERIORITY_OR_OTHER||Difference in percentage|36.38|||<|0.0001|TWO_SIDED|95.0|29.81|42.95||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||42.95|29.81|<0.0001
71887791|NCT02058147|143296798|SUPERIORITY_OR_OTHER||Difference in percentage|14.31|||<|0.0001|TWO_SIDED|95.0|8.37|20.25||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||20.25|8.37|<0.0001
71722556|NCT00661726|142962531|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.022
71722557|NCT00661726|142962532|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||0.11
71722558|NCT00661726|142962533|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.||||<0.01
71722559|NCT01631747|142962562|SUPERIORITY|||||||0.01||||||p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.|t-test, 2 sided|||Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.||||0.01
71722560|NCT01631747|142962562|SUPERIORITY|||||||0.02|||||||Regression, Linear|adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.||||||0.02
71722561|NCT01631747|142962563|SUPERIORITY|||||||0.54|||||||Chi-squared|||||||0.54
71722562|NCT01631747|142962564|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability||||||0.89
71722563|NCT01631747|142962565|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation||||||0.30
71722564|NCT01631747|142962566|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|t-test run on changes between groups. Data presented as median and IQR for ease of interpretation||||||0.69
71722565|NCT01631747|142962567|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.19
71722566|NCT01631747|142962568|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.||||||0.27
71722567|NCT01631747|142962569|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.003
71722568|NCT01631747|142962570|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.24
71722569|NCT01631747|142962571|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation||||||0.32
71722570|NCT01631747|142962572|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation||||||0.26
71722571|NCT01631747|142962573|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
71722572|NCT01631747|142962574|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
71722573|NCT01631747|142962575|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
71722574|NCT01631747|142962576|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71722575|NCT01631747|142962577|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71722576|NCT01631747|142962578|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71722577|NCT02908685|142962581|SUPERIORITY|This is the first end point and first family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.55||||0.0156|TWO_SIDED|95.0|0.3|2.81|||Mixed Model Repeated Measure Analysis|||||2.81|0.30|0.0156
71722578|NCT02908685|142962582|SUPERIORITY|This is the second end point and second family tested in the hierarchical testing. Logistic Regression Model.The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.35||||0.0469|TWO_SIDED|95.0|1.01|5.44||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald test|||||5.44|1.01|0.0469
71829858|NCT03959241|143163970|SUPERIORITY|||||||0.018||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grade 2 and 3 infections between the treatment groups||||0.018
71829859|NCT03959241|143163971|SUPERIORITY|||||||0.825||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of CMV between the treatment groups||||0. 825
71829860|NCT03959241|143163972|SUPERIORITY|||||||0.351||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Disease-Free Survival between the treatment groups||||0.351
71722579|NCT02908685|142962583|SUPERIORITY|This is the third end point and third family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.59||||0.0469|TWO_SIDED|95.0|0.55|2.62||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.62|0.55|0.0469
71722580|NCT02908685|142962584|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.58||||0.3902|TWO_SIDED|95.0|-0.53|1.69||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||1.69|-0.53|0.3902
71887792|NCT02058147|143296798|SUPERIORITY_OR_OTHER||Difference in percentage|16.35|||<|0.0001|TWO_SIDED|95.0|10.13|22.58||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."||22.58|10.13|<0.0001
71722581|NCT02908685|142962585|SUPERIORITY|This is one of the two end points in family four in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.05||||0.3902|TWO_SIDED|95.0|-6.67|2.56||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||2.56|-6.67|0.3902
71722582|NCT02908685|142962586|SUPERIORITY|This is the sixth endpoint and the fifth family tested in the hierarchical testing. The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.55||||0.3902|TWO_SIDED|95.0|0.93|4.17||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Mixed Model Repeated Measure Analysis|||||4.17|0.93|0.3902
71657298|NCT02944383|142831691|SUPERIORITY||Median Difference (Net)|-7.31||||0.2574|TWO_SIDED|95.0|-19.3|5.76||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||5.76|-19.30|0.2574
71657299|NCT02944383|142831692|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3998
71657300|NCT02944383|142831692|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.3659
71657301|NCT02944383|142831692|SUPERIORITY|||||||0.3998||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3998
71657302|NCT02944383|142831692|SUPERIORITY|||||||0.3659||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.3659
71657303|NCT02944383|142831693|SUPERIORITY|||||||0.8823||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.8823
71722583|NCT02908685|142962587|SUPERIORITY|This is the seventh endpoint and the sixth family tested in the hierarchical testing. Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.38||||0.3902|TWO_SIDED|95.0|0.7|2.74||Adjusted p-Value The adjusted p-values were derived based on all the p-values from end points in order of the hierarchical testing up to the current endpoint.|Wald-test|||CGI Improved||2.74|0.70|0.3902
71722584|NCT02908685|142962588|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|2.0||||0.043|TWO_SIDED|95.0|1.02|3.93|||Wald test|||||3.93|1.02|0.0430
71722585|NCT02908685|142962590|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|0.64||||0.1328|TWO_SIDED|95.0|-0.2|1.47|||Mixed Model Repeated Measure Analysis|||||1.47|-0.20|0.1328
71722586|NCT02908685|142962591|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.97||||0.103|TWO_SIDED|95.0|-0.4|4.34|||Mixed Model Repeated Measure Analysis|||||4.34|-0.40|0.1030
71722587|NCT02908685|142962592|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.34||||0.0451|TWO_SIDED|95.0|0.05|4.62|||Mixed Model Repeated Measure Analysis|||||4.62|0.05|0.0451
71722588|NCT02908685|142962593|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.0489|TWO_SIDED|95.0|0.01|2.56|||Mixed Model Repeated Measure Analysis|||||2.56|0.01|0.0489
71722589|NCT02908685|142962594|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.16||||0.0326|TWO_SIDED|95.0|0.18|4.14|||Mixed Model Repeated Measure Analysis|||||4.14|0.18|0.0326
71722590|NCT02908685|142962595|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-2.87||||0.3029|TWO_SIDED|95.0|-8.36|2.62|||Mixed Model Repeated Measure Analysis|||||2.62|-8.36|0.3029
71769416|NCT02446743|143039185|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|41.0|||||TWO_SIDED|95.0|33.6|47.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||47.2|33.6|
71722591|NCT02908685|142962596|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.28||||0.4937|TWO_SIDED|95.0|-2.42|4.99|||Mixed Model Repeated Measure Analysis|||||4.99|-2.42|0.4937
71722592|NCT02908685|142962597|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.35||||0.3967|TWO_SIDED|95.0|-3.11|7.8|||Mixed Model Repeated Measure Analysis|||||7.80|-3.11|0.3967
71722593|NCT02908685|142962598|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|2.96||||0.6704|TWO_SIDED|95.0|-10.78|16.7|||Mixed Model Repeated Measure Analysis|||||16.70|-10.78|0.6704
71722594|NCT02908685|142962599|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|-0.43||||0.8856|TWO_SIDED|95.0|-6.3|5.45|||Mixed Model Repeated Measure Analysis|||||5.45|-6.30|0.8856
71722595|NCT02908685|142962600|SUPERIORITY|The variables included in the MMRM model are: baseline total score, treatment, age group, visit, treatment-by-visit and baseline score-by-visit interaction.|Least Square Mean Difference|1.45||||0.1778|TWO_SIDED|95.0|-0.68|3.57|||Mixed Model Repeated Measure Analysis|||||3.57|-0.68|0.1778
71722596|NCT02908685|142962601|SUPERIORITY|Logistic Regression Model. The variables included in the logistic regression are: baseline total score, treatment and age group.|Odds Ratio (OR)|1.21||||0.6636|TWO_SIDED|95.0|0.52|2.83|||Wald-test|||CGI No Change or Improved||2.83|0.52|0.6636
71722597|NCT02370537|142962623|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-square means (LSmeans) for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% Confidence Intervals (CIs) by degree of pancreatic exocrine function using level of FEC were exponentiated.|Geometric least-squares (GLS) Mean Ratio|0.75|||||TWO_SIDED|90.0|0.52|1.1|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.10|0.52|
71722598|NCT02370537|142962623|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean ratio|0.48|||||TWO_SIDED|90.0|0.32|0.72|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.72|0.32|
71722599|NCT02370537|142962623|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.44|0.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.82|0.44|
71722600|NCT02370537|142962624|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.28|||||TWO_SIDED|90.0|0.84|1.93|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.93|0.84|
71722601|NCT02370537|142962624|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.51|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.51|
71722602|NCT02370537|142962624|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.29|||||TWO_SIDED|90.0|0.92|1.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.82|0.92|
71722603|NCT02370537|142962625|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.63|1.28|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.28|0.63|
71829861|NCT03959241|143163972|SUPERIORITY||Hazard Ratio (HR)|0.847||||0.32|TWO_SIDED|95.0|0.61|1.176||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of Disease-Free Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.176|0.610|0.320
71829862|NCT03959241|143163973|SUPERIORITY|||||||0.335||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||This is the unadjusted analysis. The null hypothesis is that there is no difference of Overall Survival between the treatment groups||||0.335
71722604|NCT02370537|142962625|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.58|||||TWO_SIDED|90.0|0.39|0.85|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.85|0.39|
71829863|NCT03959241|143163973|SUPERIORITY||Hazard Ratio (HR)|0.797||||0.252|TWO_SIDED|95.0|0.541|1.175||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of the Overall Survival hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies||1.175|0.541|0.252
71829864|NCT00463788|143163975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.126||||0.1109|TWO_SIDED|95.0|0.809|5.591|||Cochran-Mantel-Haenszel|Randomization strata: first- or second line according to Interactive Voice Response System (IVRS).||||5.591|0.809|0.1109
71829865|NCT00463788|143163976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.675||||0.0324|TWO_SIDED|95.0|0.47|0.969|||Log Rank|||||0.969|0.470|0.0324
71829866|NCT00463788|143163977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.3121|TWO_SIDED|95.0|0.561|1.204|||Log Rank|||||1.204|0.561|0.3121
71829867|NCT00463788|143163978|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.5993|TWO_SIDED|95.0|0.262|2.17|||Log Rank|||||2.170|0.262|0.5993
71829868|NCT00360698|143163980|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.68||||0.0499||95.0|0.01|28.37|||Chi-squared||Difference in percentage between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the percentage of patients with Glycosylated Haemoglobin (HbA1c) level \<7%. A sample size of 98 randomized (49/arm) patients would allow to demonstrate with 80% power that 40 % of patients in the Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group would achieve a HbA1c level \< 7 % compared to 15 % of patients in the Insulin Glargine+Metformin+Glimepiride group(5% alpha risk, 2-sided test).||28.37|0.01|0.0499
71829869|NCT00360698|143163982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.116||0.029||95.0|-0.49|-0.03||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline HbA1c as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no difference between the 2 treatment groups regarding the adjusted mean change from baseline in Glycosylated Haemoglobin (HbA1c) at the end of treatment.||-0.03|-0.49|0.029
71829870|NCT00360698|143163984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|4.987||0.0109||95.0|-22.83|-3.04||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline daily mean plasma glucose as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in daily mean plasma glucose at the end of treatment.||-3.04|-22.83|0.0109
71887793|NCT02058147|143296799|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-2.498|-1.77||Threshold for significance ≤0.05. The hierarchical testing continued only when primary hypotheses (superiority: FRC to lixisenatide; non-inferiority: FRC to insulin glargine for HbA1c) was statistically significant.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0,≥8.0%), randomization strata of second OAD use at screening \& country as fixed effects \& baseline plasma glucose excursion value as a covariate. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order.||-1.77|-2.498|<0.0001
71722605|NCT02370537|142962625|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.75|||||TWO_SIDED|90.0|0.55|1.0|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.00|0.55|
71722606|NCT02370537|142962626|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.52|||||TWO_SIDED|90.0|0.37|0.73|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.73|0.37|
71722607|NCT02370537|142962626|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.46|||||TWO_SIDED|90.0|0.32|0.67|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.67|0.32|
71722608|NCT02370537|142962626|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.4|0.7|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.70|0.40|
71722609|NCT02370537|142962627|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-squares LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.77|1.36|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.36|0.77|
71722610|NCT02370537|142962627|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS mean Ratio|0.92|||||TWO_SIDED|90.0|0.67|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.25|0.67|
71887794|NCT02058147|143296800|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.891|-0.91||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline body weight value-by-visit interaction as a covariate.||-0.91|-1.891|<0.0001
71722611|NCT02370537|142962627|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.11|||||TWO_SIDED|90.0|0.88|1.4|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||1.40|0.88|
71722612|NCT02370537|142962628|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean|0.68|||||TWO_SIDED|90.0|0.49|0.92|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.92|0.49|
71722613|NCT02370537|142962628|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||TWO_SIDED|90.0|0.42|0.84|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.84|0.42|
71722614|NCT02370537|142962628|NON_INFERIORITY_OR_EQUIVALENCE|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.7|||||TWO_SIDED|90.0|0.54|0.9|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.||0.90|0.54|
71722615|NCT01691014|142962636|SUPERIORITY_OR_OTHER|||||||0.99|||||||Fisher Exact|||DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).||||0.990
71722616|NCT01691014|142962636|SUPERIORITY_OR_OTHER|||||||0.586|||||||Fisher Exact|||DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.586
71722617|NCT01691014|142962636|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.980
71722618|NCT01691014|142962637|SUPERIORITY_OR_OTHER|||||||0.945|||||||Fisher Exact|||HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.||||0.945
71722619|NCT01691014|142962637|SUPERIORITY_OR_OTHER|||||||0.458|||||||Fisher Exact|||HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.||||0.458
71769417|NCT02446743|143039186|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|20.0|||||TWO_SIDED|95.0|15.0|25.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||25.4|15.0|
71722620|NCT01691014|142962637|SUPERIORITY_OR_OTHER|||||||0.896|||||||Fisher Exact|||HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.||||0.896
71722621|NCT01691014|142962637|SUPERIORITY_OR_OTHER|||||||0.39|||||||Fisher Exact|||HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.||||0.390
71722622|NCT00066703|142962660|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.717||||0.0002|TWO_SIDED|95.0|0.602|0.855|||Log Rank||T+OFS is the reference group in the estimation of the hazard ratio.|||0.855|0.602|.0002
71722623|NCT00066703|142962661|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.664|||<|0.0001|TWO_SIDED|95.0|0.548|0.804|||Log Rank||T+OFS is the reference group for the estimation of the hazard ratio.|||.804|.548|<.0001
71722624|NCT00066703|142962662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.777||||0.02|TWO_SIDED|95.0|0.624|0.967|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||0.967|0.624|0.02
71722625|NCT00066703|142962663|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.84|TWO_SIDED|95.0|0.79|1.22|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio|||1.22|0.79|0.84
71722626|NCT01696968|142962664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
71722627|NCT01696968|142962666|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.95|1.0|||Poisson regression|||||1.00|0.95|
71722628|NCT01696968|142962668|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.98|1.12|||Poisson regression|||||1.12|0.98|
71722629|NCT01696968|142962672|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.91|1.07|||Poisson regression|||||1.07|0.91|
71722630|NCT04925076|142962738|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108)=.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history X sex interaction.||||.92
71722631|NCT04925076|142962738|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,108) = .01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X sex interaction.||||.92
71722632|NCT04925076|142962738|SUPERIORITY|||||||0.61|||||||Chi-squared|F(1,108) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the condition X family history interaction.||||.61
71722633|NCT04925076|142962738|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,108) = 6.75||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the family history X sex interaction.||||.01
71722634|NCT04925076|142962738|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,108) = 3.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of condition.||||.05
71722635|NCT04925076|142962738|SUPERIORITY|||||||0.003|||||||ANOVA|F(1,108) = 9.53||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of family history.||||.003
71722636|NCT04925076|142962738|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,108) = 2.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.12
71722637|NCT04925076|142962739|SUPERIORITY|||||||0.38|||||||ANOVA|F(1,107) = 0.78||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history X sex interaction.||||.38
71769418|NCT02446743|143039186|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|18.0|||||TWO_SIDED|95.0|10.7|27.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.0|10.7|
71722638|NCT04925076|142962739|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,107) = 0.27||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X sex interaction.||||.27
71657304|NCT02944383|142831693|SUPERIORITY|||||||0.3788||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.3788
71657305|NCT02944383|142831693|SUPERIORITY|||||||0.1091||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1091
71657306|NCT02944383|142831693|SUPERIORITY|||||||0.6867||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.6867
71657307|NCT02944383|142831693|SUPERIORITY||Median Difference (Net)|9.07||||0.3156|TWO_SIDED|95.0|-12.22|36.34||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||36.34|-12.22|0.3156
71657308|NCT02944383|142831693|SUPERIORITY||Median Difference (Net)|-0.3||||0.9734|TWO_SIDED|95.0|-24.58|25.43||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA||Estimates generated from Hodges-Lehmann method.|EOS (average of week 10 and 12)||25.43|-24.58|0.9734
71657309|NCT02944383|142831694|SUPERIORITY|||||||0.9772||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.9772
71722639|NCT04925076|142962739|SUPERIORITY|||||||0.7|||||||ANOVA|F(1,107) = 0.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the condition X family history interaction.||||.70
71722640|NCT04925076|142962739|SUPERIORITY|||||||0.05|||||||ANOVA|F(1,107) = 3.87||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the family history X sex interaction.||||.05
71722641|NCT04925076|142962739|SUPERIORITY|||||||0.03|||||||ANOVA|F(1,107) = 5.18||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of condition.||||.03
71722642|NCT04925076|142962739|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,107) = 2.24||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of family history.||||.14
71657310|NCT02944383|142831694|SUPERIORITY|||||||0.5213||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 10||||0.5213
71657311|NCT02944383|142831694|SUPERIORITY|||||||0.1582||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.1582
71657312|NCT02944383|142831694|SUPERIORITY|||||||0.4588||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||Week 12||||0.4588
71657313|NCT02944383|142831694|SUPERIORITY|||||||0.4264||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.4264
71722643|NCT04925076|142962739|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,107) = 17.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain tolerance. Here we report the results of the analysis of the main effect of sex.||||<.001
71722644|NCT04925076|142962740|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,107) = 0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history X sex interaction.||||.83
71722645|NCT04925076|142962740|SUPERIORITY|||||||0.12|||||||ANOVA|F(1,107) = 2.43||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X sex interaction.||||.12
71722646|NCT04925076|142962740|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,107) = 1.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the condition X family history interaction.||||.25
71722647|NCT04925076|142962740|SUPERIORITY|||||||0.58|||||||ANOVA|F(1,107) = 0.31||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the family history X sex interaction.||||.58
71722648|NCT04925076|142962740|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,107) = 0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of condition.||||.90
71722649|NCT04925076|142962740|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,107) = .004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of family history.||||.95
71722650|NCT04925076|142962740|SUPERIORITY|||||||0.68|||||||ANOVA|F(1,107) = 0.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of sex.||||.68
71722651|NCT04925076|142962741|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,107) = 0.83||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history X sex interaction.||||.36
71722652|NCT04925076|142962741|SUPERIORITY|||||||0.24|||||||ANOVA|F(1,108) = 1.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X sex interaction.||||.24
71769419|NCT02446743|143039186|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|21.0|||||TWO_SIDED|95.0|15.6|28.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||28.8|15.6|
71722653|NCT04925076|142962741|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,108) = 0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the condition X family history interaction.||||.60
71722654|NCT04925076|142962741|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,108) = 0.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the family history X sex interaction.||||.99
71722655|NCT04925076|142962741|SUPERIORITY||||||<|0.001|||||||ANOVA|F(1,108) = 139.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of condition.||||<.001
71722656|NCT04925076|142962741|SUPERIORITY|||||||0.84|||||||ANOVA|F(1,108) = 0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of family history.||||.84
71722657|NCT04925076|142962741|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,108) = 0.30||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of sex.||||.59
71722658|NCT04925076|142962742|SUPERIORITY|||||||0.66|||||||ANOVA|F(1,93)=0.19||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.66
71722659|NCT04925076|142962742|SUPERIORITY|||||||0.41|||||||ANOVA|F(1,93)=0.69||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.41
71722660|NCT04925076|142962742|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.74||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
71769420|NCT02446743|143039186|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|12.0|||||TWO_SIDED|95.0|8.0|16.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.8|8.0|
71769421|NCT02446743|143039186|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.8|28.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.6|12.8|
71769422|NCT02446743|143039186|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|6.0|||||TWO_SIDED|95.0|1.5|12.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.2|1.5|
71769423|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|Vaccine group difference|27.0|||||TWO_SIDED|95.0|21.9|33.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.3|21.9|
71769424|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|31.0|||||TWO_SIDED|95.0|21.8|40.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||40.3|21.8|
71769425|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|26.0|||||TWO_SIDED|95.0|19.2|33.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||33.1|19.2|
71722661|NCT04925076|142962742|SUPERIORITY|||||||0.22|||||||ANOVA|F(1,93)=1.54||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.22
71722662|NCT04925076|142962742|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.06
71722663|NCT04925076|142962742|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.99
71722664|NCT04925076|142962742|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=2.88||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on dorsolateral prefrontal cortex activation. Here we report the results of the analysis of the main effect of sex.||||.09
71722665|NCT04925076|142962743|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.55
71722666|NCT04925076|142962743|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.36
71769426|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|14.3|24.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||24.3|14.3|
71829871|NCT00360698|143163985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.431||0.5762||95.0|-0.61|1.1||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline weight as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in weight at the end of treatment.||1.1|-0.61|0.5762
71722667|NCT04925076|142962743|SUPERIORITY|||||||0.36|||||||ANOVA|F(1,93)=0.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.36
71722668|NCT04925076|142962743|SUPERIORITY|||||||0.17|||||||ANOVA|F(1,93)=1.93||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.17
71722669|NCT04925076|142962743|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of condition.||||.55
71722670|NCT04925076|142962743|SUPERIORITY|||||||0.43|||||||ANOVA|F(1,93)=0.63||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hypothalamus activation. Here we report the results of the analysis of the main effect of family history.||||.43
71722671|NCT04925076|142962743|SUPERIORITY|||||||0.33|||||||ANOVA|F(1,93)=0.96||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain threshold. Here we report the results of the analysis of the main effect of sex.||||.33
71722672|NCT04925076|142962744|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.34
71722673|NCT04925076|142962744|SUPERIORITY|||||||0.88|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.88
71722674|NCT04925076|142962744|SUPERIORITY|||||||0.56|||||||ANOVA|F(1,93)=0.34||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.56
71722675|NCT04925076|142962744|SUPERIORITY|||||||0.9|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.90
71722676|NCT04925076|142962744|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.59||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of condition.||||.45
71829872|NCT00360698|143163988|SUPERIORITY_OR_OTHER|||||||0.958||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.958
71769427|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.1|27.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||27.5|12.1|
71722677|NCT04925076|142962744|SUPERIORITY|||||||0.85|||||||ANOVA|F(1,93)=0.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex activation. Here we report the results of the analysis of the main effect of family history.||||.85
71657314|NCT02944383|142831694|SUPERIORITY|||||||0.8107||||||Results are obtained using a model where the outcome is ranked, randomized treatment group, randomized baseline statin (yes or no), \& randomized qualifying TG stratum are included as factors, \& outcome (ranked) at baseline is included as a covariate.|Ranked ANCOVA|||EOS (average of week 10 and 12)||||0.8107
71657315|NCT02944383|142831695|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0093|TWO_SIDED|95.0|1.51|19.08||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||19.08|1.51|0.0093
71657316|NCT02944383|142831695|SUPERIORITY||Odds Ratio (OR)|2.57||||0.107|TWO_SIDED|95.0|0.82|8.07||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 10||8.07|0.82|0.1070
71657317|NCT02944383|142831695|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0865|TWO_SIDED|95.0|0.87|7.53||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic|||Week 12||7.53|0.87|0.0865
71657318|NCT02944383|142831695|SUPERIORITY||Odds Ratio (OR)|1.57||||0.399|TWO_SIDED|95.0|0.55|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|Week 12||4.48|0.55|0.3990
71722678|NCT04925076|142962744|SUPERIORITY|||||||0.64|||||||ANOVA|F(1,93)=0.22||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on medial prefrontal cortex. Here we report the results of the analysis of the main effect of sex.||||.64
71887795|NCT02058147|143296801|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|95.0|-2.246|-1.682||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline FPG value-by-visit interaction as a covariate.||-1.682|-2.246|<0.0001
71657319|NCT02944383|142831695|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0772|TWO_SIDED|95.0|0.9|8.42||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||8.42|0.90|0.0772
71657320|NCT02944383|142831695|SUPERIORITY||Odds Ratio (OR)|1.54||||0.4315|TWO_SIDED|95.0|0.53|4.48||Logistic regression results are obtained using a model with randomized treatment group, randomized baseline statin (yes or no), and baseline TG value as independent factors.|Regression, Logistic||The OR is an estimate of the odds of achieving a TG value \< 500 mg/dL associated with the corresponding Gemcabene group relative to the placebo group at a given visit.|EOS (average of week 10 and 12)||4.48|0.53|0.4315
71657321|NCT00364949|142831696|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
71657322|NCT00364949|142831697|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
71722679|NCT04925076|142962745|SUPERIORITY|||||||0.3|||||||ANOVA|F(1,93)=1.07||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.30
71722680|NCT04925076|142962745|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.11
71722681|NCT04925076|142962745|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X family history interaction.||||.39
71722682|NCT04925076|142962745|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.02||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the family history X sex interaction.||||.89
71722683|NCT04925076|142962745|SUPERIORITY|||||||0.01|||||||ANOVA|F(1,93)=6.72||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of condition.||||.01
71769428|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|19.0|||||TWO_SIDED|95.0|13.3|26.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||26.4|13.3|
71722684|NCT04925076|142962745|SUPERIORITY|||||||0.08|||||||ANOVA|F(1,93)=3.15||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of family history.||||.08
71722685|NCT04925076|142962745|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.71||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the main effect of sex.||||.06
71657323|NCT00364949|142831698|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|||||||0.156
71657324|NCT00364949|142831699|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||t-test, 2 sided|||||||0.770
71657325|NCT00364949|142831700|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||t-test, 2 sided|||||||0.325
71657326|NCT02504671|142831739|OTHER||Odds Ratio (OR)|2.12||||0.547|TWO_SIDED|95.0|0.18|24.52|||Regression, Logistic||95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.|||24.52|0.18|0.547
71657327|NCT02504671|142831739|OTHER||Odds Ratio (OR)|7.11||||0.077|TWO_SIDED|95.0|0.81|62.44|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.44|0.81|0.077
71657328|NCT02504671|142831739|OTHER||Odds Ratio (OR)|8.39||||0.053|TWO_SIDED|95.0|0.98|72.14|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||72.14|0.98|0.053
71657329|NCT02504671|142831739|OTHER||Odds Ratio (OR)|5.69||||0.122|TWO_SIDED|95.0|0.63|51.4|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.40|0.63|0.122
71657330|NCT02504671|142831739|OTHER||Odds Ratio (OR)|5.4||||0.134|TWO_SIDED|95.0|0.6|48.83|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.83|0.60|0.134
71657331|NCT02504671|142831740|OTHER||Mean Difference (Net)|0.46||||0.905|TWO_SIDED|95.0|-7.13|8.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|Mixed Model Repeated Measures (MMRM)||CRP, Week 12|||8.05|-7.13|0.905
71722686|NCT04925076|142962746|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.14||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.29
71722687|NCT04925076|142962746|SUPERIORITY|||||||0.1|||||||ANOVA|F(1,93)=2.84||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on nucleus accumbens activation. Here we report the results of the analysis of the condition X sex interaction.||||.10
71722688|NCT04925076|142962746|SUPERIORITY|||||||0.49|||||||ANOVA|F(1,93)=0.47||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the condition X family history interaction.||||.49
71722689|NCT04925076|142962746|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the family history X sex interaction.||||.99
71722690|NCT04925076|142962746|SUPERIORITY|||||||0.13|||||||ANOVA|F(1,93)=2.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of condition.||||.13
71722691|NCT04925076|142962746|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of family history.||||.82
71657332|NCT02504671|142831740|OTHER||Mean Difference (Net)|-3.36||||0.387|TWO_SIDED|95.0|-11.0|4.28||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.28|-11.00|0.387
71657333|NCT02504671|142831740|OTHER||Mean Difference (Net)|-2.58||||0.495|TWO_SIDED|95.0|-10.04|4.87||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||4.87|-10.04|0.495
71657334|NCT02504671|142831740|OTHER||Mean Difference (Net)|-7.68||||0.14|TWO_SIDED|95.0|-17.92|2.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||2.55|-17.92|0.140
71657335|NCT02504671|142831740|OTHER||Mean Difference (Net)|-13.68||||0.009|TWO_SIDED|95.0|-23.85|-3.52||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-3.52|-23.85|0.009
71657336|NCT02504671|142831740|OTHER||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-27.44|-7.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.35|-27.44|<0.001
71657337|NCT02504671|142831740|OTHER||Mean Difference (Net)|-2.42||||0.118|TWO_SIDED|95.0|-5.45|0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.62|-5.45|0.118
71657338|NCT02504671|142831740|OTHER||Mean Difference (Net)|-3.17||||0.041|TWO_SIDED|95.0|-6.2|-0.14||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-0.14|-6.20|0.041
71657339|NCT02504671|142831740|OTHER||Mean Difference (Net)|-4.56||||0.003|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.003
71657340|NCT02504671|142831740|OTHER||Mean Difference (Net)|-2.3||||0.172|TWO_SIDED|95.0|-5.61|1.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TC28, Week 12|||1.01|-5.61|0.172
71657341|NCT02504671|142831740|OTHER||Mean Difference (Net)|-3.92||||0.02|TWO_SIDED|95.0|-7.22|-0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.62|-7.22|0.020
71722692|NCT04925076|142962746|SUPERIORITY|||||||0.02|||||||ANOVA|F(1,93)=6.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on periaqueductal gray activation. Here we report the results of the analysis of the main effect of sex.||||0.02
71722693|NCT04925076|142962747|SUPERIORITY|||||||0.32|||||||ANOVA|F(1,93)=1.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.32
71722694|NCT04925076|142962747|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,93)=0.000||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X sex interaction.||||.99
71722695|NCT04925076|142962747|SUPERIORITY|||||||0.83|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the condition X family history interaction.||||.83
71722696|NCT04925076|142962747|SUPERIORITY|||||||0.75|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the family history X sex interaction.||||.75
71722697|NCT04925076|142962747|SUPERIORITY|||||||0.62|||||||ANOVA|F(1,93)=0.25||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of condition.||||.62
71722698|NCT04925076|142962747|SUPERIORITY|||||||0.92|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of family history.||||.92
71722699|NCT04925076|142962747|SUPERIORITY|||||||0.39|||||||ANOVA|F(1,93)=0.76||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on anterior cingulate cortex activation. Here we report the results of the analysis of the main effect of sex.||||.39
71722700|NCT04925076|142962748|SUPERIORITY|||||||0.5|||||||ANOVA|F(1,93)=0.45||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.50
71722701|NCT04925076|142962748|SUPERIORITY|||||||0.28|||||||ANOVA|F(1,93)=1.20||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X sex interaction.||||.28
71722702|NCT04925076|142962748|SUPERIORITY|||||||0.6|||||||ANOVA|F(1,93)=0.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the condition X family history interaction.||||.60
71722703|NCT04925076|142962748|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,93)=4.48||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the family history X sex interaction.||||.04
71722704|NCT04925076|142962748|SUPERIORITY|||||||0.25|||||||ANOVA|F(1,93)=1.37||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of condition.||||.25
71722705|NCT04925076|142962748|SUPERIORITY|||||||0.89|||||||ANOVA|F(1,93)=0.01||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of family history.||||.89
71722706|NCT04925076|142962748|SUPERIORITY|||||||0.26|||||||ANOVA|F(1,93)=1.28||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on amygdala activation. Here we report the results of the analysis of the main effect of sex.||||.26
71722707|NCT04925076|142962749|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.76
71722708|NCT04925076|142962749|SUPERIORITY|||||||0.09|||||||ANOVA|F(1,93)=3.00||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X sex interaction.||||.09
71722709|NCT04925076|142962749|SUPERIORITY|||||||0.76|||||||ANOVA|F(1,93)=0.10||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the condition X family history interaction.||||.76
71722710|NCT04925076|142962749|SUPERIORITY|||||||0.77|||||||ANOVA|F(1,93)=0.09||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the family history X sex interaction.||||.77
71722711|NCT04925076|142962749|SUPERIORITY|||||||0.52|||||||ANOVA|F(1,93)=0.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of condition.||||.52
71722712|NCT04925076|142962749|SUPERIORITY|||||||0.93|||||||ANOVA|F(1,93)=0.007||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on pain hippocampus activation. Here we report the results of the analysis of the main effect of family history.||||.93
71722713|NCT04925076|142962749|SUPERIORITY|||||||0.42|||||||ANOVA|F(1,93)=0.64||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on hippocampus activation. Here we report the results of the analysis of the main effect of sex.||||.42
71769429|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.2|49.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||49.9|35.2|
71722714|NCT04925076|142962750|SUPERIORITY|||||||0.44|||||||ANOVA|F(1,93)=0.62||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.44
71722715|NCT04925076|142962750|SUPERIORITY|||||||0.27|||||||ANOVA|F(1,93)=1.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X sex interaction.||||.27
71722716|NCT04925076|142962750|SUPERIORITY|||||||0.06|||||||ANOVA|F(1,93)=3.66||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the condition X family history interaction.||||.06
71722717|NCT04925076|142962750|SUPERIORITY|||||||0.73|||||||ANOVA|F(1,93)=0.13||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the family history X sex interaction.||||.73
71722718|NCT04925076|142962750|SUPERIORITY|||||||0.047|||||||ANOVA|F(1,93)=4.04||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of condition.||||.047
71722719|NCT04925076|142962750|SUPERIORITY|||||||0.97|||||||ANOVA|F(1,93)=0.001||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of family history.||||.97
71769430|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|58.0|||||TWO_SIDED|95.0|46.6|67.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||67.3|46.6|
71722720|NCT04925076|142962750|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on insula activation. Here we report the results of the analysis of the main effect of sex.||||.82
71722721|NCT04925076|142962751|SUPERIORITY|||||||0.45|||||||ANOVA|F(1,93)=0.57||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||0.45
71722722|NCT04925076|142962751|SUPERIORITY|||||||0.59|||||||ANOVA|F(1,93)=0.29||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X sex interaction.||||.59
71722723|NCT04925076|142962751|SUPERIORITY|||||||0.07|||||||ANOVA|F(1,93)=3.41||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the condition X family history interaction.||||.07
71722724|NCT04925076|142962751|SUPERIORITY|||||||0.61|||||||ANOVA|F(1,93)=0.26||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the family history X sex interaction.||||.61
71722725|NCT04925076|142962751|SUPERIORITY|||||||0.82|||||||ANOVA|F(1,93)=0.05||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of condition.||||.82
71722726|NCT04925076|142962751|SUPERIORITY|||||||0.63|||||||ANOVA|F(1,93)=0.23||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of family history.||||.63
71722727|NCT04925076|142962751|SUPERIORITY|||||||0.55|||||||ANOVA|F(1,93)=0.36||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on postcentral gyrus activation. Here we report the results of the analysis of the main effect of sex.||||.55
71722728|NCT04925076|142962752|SUPERIORITY|||||||0.57|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history X sex interaction.||||.57
71722729|NCT04925076|142962752|SUPERIORITY|||||||0.14|||||||ANOVA|F(1,93)=2.17||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X sex interaction.||||.14
71769431|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|33.0|||||TWO_SIDED|95.0|23.0|42.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||42.5|23.0|
71722730|NCT04925076|142962752|SUPERIORITY|||||||0.69|||||||ANOVA|F(1,93)=0.32||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the condition X family history interaction.||||.69
71722731|NCT04925076|142962752|SUPERIORITY|||||||0.34|||||||ANOVA|F(1,93)=0.92||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the family history X sex interaction.||||.34
71887796|NCT02058147|143296802|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-1.645|-1.158||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction as a covariate.||-1.158|-1.645|<0.0001
71722732|NCT04925076|142962752|SUPERIORITY|||||||0.29|||||||ANOVA|F(1,93)=1.16||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of condition.||||0.29
71722733|NCT04925076|142962752|SUPERIORITY|||||||0.95|||||||ANOVA|F(1,93)=0.004||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of family history.||||.95
71722734|NCT04925076|142962752|SUPERIORITY|||||||0.11|||||||ANOVA|F(1,93)=2.65||2 (beverage condition: alcohol vs. placebo) X 2 (family history: positive vs. negative) X 2 (sex: men vs. women) mixed general linear model on thalamus activation. Here we report the results of the analysis of the main effect of sex.||||.11
71722735|NCT05791565|142962785|OTHER||Ratio of Geometric LS Means|1.1609|||||TWO_SIDED|90.0|1.0221|1.3185|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.3185|1.0221|
71722736|NCT05791565|142962786|OTHER||Ratio of the Geometric LS Means|1.4081|||||TWO_SIDED|90.0|1.2998|1.5255|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5255|1.2998|
71722737|NCT05791565|142962787|OTHER||Ratio of the Geometric LS Means|1.3885|||||TWO_SIDED|90.0|1.2793|1.507|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.5070|1.2793|
71722738|NCT05791565|142962788|OTHER||Ratio of the Geometric LS Means|1.3141|||||TWO_SIDED|90.0|1.1816|1.4614|||||Ratio of the Geometric LS means = Geometric LS mean of the Salbutamol HFA-152a MDI to the Geometric LS mean of the Salbutamol HFA-134a MDI.|||1.4614|1.1816|
71722739|NCT02388165|142962816|SUPERIORITY||Vaccine Efficacy (VE)|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The confidence interval (CI) was calculated using the Clopper-Pearson method.|||55.81|-126.30|
71722740|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|8.3|||<|0.001|TWO_SIDED|95.0|6.9|9.8|||Miettinen and Nurminen|||Redness: Any||9.8|6.9|<0.001
71722741|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|4.4|||||TWO_SIDED|95.0|3.3|5.6||||||Redness: Mild||5.6|3.3|
71722742|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|2.3|4.0||||||Redness: Moderate||4.0|2.3|
71722743|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|0.5|1.4||||||Redness: Severe||1.4|0.5|
71722744|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|7.0|||<|0.001|TWO_SIDED|95.0|5.7|8.4|||Miettinen and Nurminen|||Swelling: Any||8.4|5.7|<0.001
71722745|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|3.9|||||TWO_SIDED|95.0|2.8|5.0||||||Swelling: Mild||5.0|2.8|
71722746|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|2.4|||||TWO_SIDED|95.0|1.7|3.3||||||Swelling: Moderate||3.3|1.7|
71722747|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|0.4|1.2||||||Swelling: Severe||1.2|0.4|
71722748|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|15.7|||<|0.001|TWO_SIDED|95.0|13.3|18.1|||Miettinen and Nurminen|||Pain at the injection site: Any||18.1|13.3|<0.001
71722749|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|12.2|||||TWO_SIDED|95.0|10.0|14.5||||||Pain at the injection site: Mild||14.5|10.0|
71722750|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|3.0|||||TWO_SIDED|95.0|1.9|4.2||||||Pain at the injection site: Moderate||4.2|1.9|
71722751|NCT02388165|142962817|SUPERIORITY||Difference in percentage of participants|0.5|||||TWO_SIDED|95.0|0.1|1.0||||||Pain at the injection site: Severe||1.0|0.1|
71722752|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.6||||0.146|TWO_SIDED|95.0|-0.2|1.6|||Miettinen and Nurminen|||Fever: Any||1.6|-0.2|0.146
71722753|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.4|||||TWO_SIDED|95.0|-0.3|1.2||||||Fever: 38.0 degree C to 38.4 degree C||1.2|-0.3|
71722754|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.4|0.6||||||Fever: 38.5 degree C to 38.9 degree C||0.6|-0.4|
71722755|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.5||||||Fever: 39.0 degree C to 40.0 degree C||0.5|-0.2|
71722756|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.1|||||TWO_SIDED|95.0|-0.2|0.3||||||Fever: \>40.0 degree C||0.3|-0.2|
71722757|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|2.9||||0.093||95.0|-0.5|6.2|||Miettinen and Nurminen|||Fatigue: Any||6.2|-0.5|0.093
71769432|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|13.0|||||TWO_SIDED|95.0|8.8|18.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||18.3|8.8|
71722758|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-0.9|3.7||||||Fatigue: Mild||3.7|-0.9|
71722759|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.3|||||TWO_SIDED|95.0|-1.6|4.2||||||Fatigue: Moderate||4.2|-1.6|
71722760|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.2|||||TWO_SIDED|95.0|-1.2|1.6||||||Fatigue: Severe||1.6|-1.2|
71722761|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.2||||0.443|TWO_SIDED|95.0|-1.9|4.4|||Miettinen and Nurminen|||Headache: Any||4.4|-1.9|0.443
71722762|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|-0.3|||||TWO_SIDED|95.0|-2.9|2.3||||||Headache: Mild||2.3|-2.9|
71722763|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.5|||||TWO_SIDED|95.0|-0.7|3.8||||||Headache: Moderate||3.8|-0.7|
71722764|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-0.8|0.8||||||Headache: Severe||0.8|-0.8|
71722765|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.0||||0.462|TWO_SIDED|95.0|-1.6|3.4|||Miettinen and Nurminen|||Diarrhea: Any||3.4|-1.6|0.462
71722766|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.5|3.0||||||Diarrhea: Mild||3.0|-1.5|
71722767|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.5||||||95.0|-0.7|1.7||||||Diarrhea: Moderate||1.7|-0.7|
71829873|NCT00360698|143163989|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of nocturnal symptomatic hypoglycemia with plasma glucose \<70 mg/dL during the treatment period.||||0.302
71722768|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Diarrhea: Severe||0.2|-1.0|
71722769|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|-0.6||||0.3||95.0|-1.8|0.5|||Miettinen and Nurminen|||Vomiting: Any||0.5|-1.8|0.300
71722770|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|-0.2|||||TWO_SIDED|95.0|-1.3|0.8||||||Vomiting: Mild||0.8|-1.3|
71722771|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|-0.4||||||95.0|-0.9|0.1||||||Vomiting: Moderate||0.1|-0.9|
71722772|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.7||||0.276||95.0|-1.3|4.7|||Miettinen and Nurminen|||Muscle pain: Any||4.7|-1.3|0.276
71722773|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.8|||||TWO_SIDED|95.0|-1.2|2.8||||||Muscle pain: Mild||2.8|-1.2|
71722774|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.1|||||TWO_SIDED|95.0|-1.4|3.5||||||Muscle pain: Moderate||3.5|-1.4|
71722775|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|-0.2||||||95.0|-1.2|0.8||||||Muscle pain: Severe||0.8|-1.2|
71722776|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.7||||0.273|TWO_SIDED|95.0|-1.3|4.6|||Miettinen and Nurminen|||Joint pain: Any||4.6|-1.3|0.273
71722777|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|1.6|||||TWO_SIDED|95.0|-0.2|3.6||||||Joint pain: Mild||3.6|-0.2|
71722778|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.0|||||TWO_SIDED|95.0|-2.6|2.4||||||Joint pain: Moderate||2.4|-2.6|
71722779|NCT02388165|142962818|SUPERIORITY||Difference in percentage of participants|0.1||||||95.0|-0.9|1.0||||||Joint pain: Severe||1.0|-0.9|
71722780|NCT02388165|142962826|SUPERIORITY||VE|0.0|||||TWO_SIDED|95.0|-126.3|55.81|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||55.81|-126.30|
71722781|NCT02388165|142962827|SUPERIORITY||VE|-9.09|||||TWO_SIDED|95.0|-104.06|41.41|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||41.41|-104.06|
71722782|NCT02388165|142962828|SUPERIORITY||VE|-8.7|||||TWO_SIDED|95.0|-100.42|40.8|||||VE was calculated as 1-(P/\[1-P\]\*100), where P is the number of SA4Ag cases divided by the total number of cases. The CI was calculated using the Clopper-Pearson method.|||40.80|-100.42|
71722783|NCT01942668|142962887|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
71722784|NCT01942668|142962887|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
71722785|NCT01942668|142962887|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||1.59|-11.21|0.141
71722786|NCT01942668|142962887|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
71829874|NCT00360698|143163990|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of severe symptomatic hypoglycemia during the treatment period.||||0.192
71722787|NCT01942668|142962888|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
71829875|NCT02547922|143163995|SUPERIORITY||Geometric Mean Ratio|1.031||||0.9052|TWO_SIDED|95.0|0.621|1.713||The p-values presented are unadjusted and was compared with the respective adjusted significance level (α). If α is not displayed, no formal testing can be performed and the corresponding p-value was nominal.|Mixed Models Analysis||Geometric mean ratio \>1 favours placebo.|The model includes fixed effects for treatment group, visit, stratification factors, log-transformed 24-hour UPCR at baseline, and treatment-by-visit interaction. All data up to and including the date of discontinuation of study treatment were included in the analysis.||1.713|0.621|0.9052
71657342|NCT02504671|142831740|OTHER||Mean Difference (Net)|-5.72|||<|0.001|TWO_SIDED|95.0|-8.98|-2.45||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-2.45|-8.98|<0.001
71722788|NCT01942668|142962888|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
71722789|NCT01942668|142962888|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
71722790|NCT01942668|142962888|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
71722791|NCT01942668|142962889|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
71722792|NCT01942668|142962889|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
71722793|NCT01942668|142962889|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.07|-0.17|0.401
71722794|NCT01942668|142962889|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.02|-0.21|0.100
71722795|NCT01942668|142962890|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
71829876|NCT02547922|143163996|SUPERIORITY||Difference in estimates|-0.08||||0.9929|TWO_SIDED|95.0|-16.92|16.76||At Week 52, the p-values presented are unadjusted and will be compared to the respective adjusted significance level (α). If α is not displayed no formal testing can be performed and the corresponding p-value is nominal.|Cochran-Mantel-Haenszel|||The statistical analysis represents the estimated percentage of responders. The responder/non-responder rates (percentages), the difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach.||16.76|-16.92|0.9929
71829877|NCT02336438|143164007|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.99
71829878|NCT02336438|143164008|SUPERIORITY_OR_OTHER|||||||0.4922|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.4922
71829879|NCT02336438|143164009|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.77
71829880|NCT02336438|143164010|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.0156
71829881|NCT02336438|143164011|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.020
71829882|NCT02336438|143164012|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.13
71829883|NCT00392054|143164039|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.0016|TWO_SIDED|95.0|0.35|0.9||Cox regression analysis, stratified by clinical site, was performed and presented as hazard ratios with 95% confidence intervals and a two-sided p-value testing of less than or equal to 0.05 (two-sided) for the Wald test.|Regression, Cox|||Event rates were plotted over time using Kaplan-Meier methodology. Only events occurring after the 90-day treatment period were included in the final analysis. Treatment groups were analyzed on an intention-to-treat basis.||0.90|0.35|0.0016
71829884|NCT00392054|143164041|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.03|TWO_SIDED|95.0|0.33|0.95|||Regression, Cox|||||0.95|0.33|0.03
71722796|NCT01942668|142962890|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
71722797|NCT01942668|142962890|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
71722798|NCT01942668|142962890|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM|||0.03|-0.36|0.096
71769433|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|20.0|||||TWO_SIDED|95.0|12.6|29.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||29.0|12.6|
71769434|NCT02446743|143039187|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|8.0|||||TWO_SIDED|95.0|2.7|14.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen||14.7|2.7|
71769435|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|40.0|||||TWO_SIDED|95.0|33.9|46.3|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.3|33.9|
71769436|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|49.0|||||TWO_SIDED|95.0|38.9|58.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|38.9|
71769437|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|34.0|||||TWO_SIDED|95.0|26.6|42.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||42.2|26.6|
71769438|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|27.0|||||TWO_SIDED|95.0|21.6|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|21.6|
71769439|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|23.0|||||TWO_SIDED|95.0|15.5|32.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.0|15.5|
71769440|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|30.0|||||TWO_SIDED|95.0|22.9|38.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.1|22.9|
71769441|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|43.0|||||TWO_SIDED|95.0|35.1|50.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.6|35.1|
71769442|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|51.0|||||TWO_SIDED|95.0|39.3|60.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||60.9|39.3|
71829885|NCT00392054|143164042|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.017|TWO_SIDED|95.0|0.3|0.89|||Regression, Cox|||||0.89|0.3|0.017
71829886|NCT00392054|143164043|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.28|0.4|||Regression, Cox|||||0.4|0.28|<0.0001
71829887|NCT00392054|143164044|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.66|TWO_SIDED|95.0|0.42|1.72|||Regression, Cox|||||1.72|0.42|0.66
71829888|NCT04975308|143164047|SUPERIORITY||Hazard Ratio (HR)|0.867||||0.1158|TWO_SIDED|95.0|0.724|1.039|||Log Rank|||||1.039|0.724|0.1158
71829889|NCT04975308|143164048|SUPERIORITY||Hazard Ratio (HR)|0.569|||<|0.0001|TWO_SIDED|95.0|0.441|0.733|||Log Rank|||||0.733|0.441|<0.0001
71829890|NCT04975308|143164049|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0008|TWO_SIDED|95.0|0.464|0.821|||Log Rank|||||0.821|0.464|0.0008
71722799|NCT01942668|142962891|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
71722800|NCT01942668|142962891|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
71722801|NCT01942668|142962891|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
71722802|NCT01942668|142962891|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
71722803|NCT01942668|142962891|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
71722804|NCT01942668|142962892|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.06||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.||1.06||
71722805|NCT01942668|142962892|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.98||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.||0.98||
71722806|NCT01942668|142962892|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||0.97||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.||0.97||
71769443|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|41.0|||||TWO_SIDED|95.0|29.9|50.2|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||50.2|29.9|
71722807|NCT01942668|142962892|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||1.09||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.||1.09||
71722808|NCT01942668|142962892|OTHER|Per FDA guidance hyperplasia proportion must be \<=1% with an upper bound of the one-sided 95% confidence interval \<=4%.|incidence rate|0.0|||||ONE_SIDED|95.0||3.2||Between group comparison was not performed.|||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.||3.20||
71722809|NCT01942668|142962893|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.51||0.588|TWO_SIDED|95.0|-3.57|6.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.30|-3.57|0.588
71722810|NCT01942668|142962893|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|2.47||0.601|TWO_SIDED|95.0|-3.56|6.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.15|-3.56|0.601
71722811|NCT01942668|142962893|SUPERIORITY||Mean Difference (Final Values)|3.17|STANDARD_ERROR_OF_MEAN|2.49||0.202|TWO_SIDED|95.0|-1.71|8.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.06|-1.71|0.202
71722812|NCT01942668|142962893|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.46||0.431|TWO_SIDED|95.0|-6.76|2.89||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.89|-6.76|0.431
71722813|NCT01942668|142962894|SUPERIORITY||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|3.05||0.154|TWO_SIDED|95.0|-10.34|1.64||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.64|-10.34|0.154
71887797|NCT02058147|143296802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.892|-0.495||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction, as a covariate.||-0.495|-0.892|<0.0001
71722814|NCT01942668|142962894|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|3.0||0.956|TWO_SIDED|95.0|-6.06|5.73||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||5.73|-6.06|0.956
71769444|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 (Group 3B vs. Group B\_0\_1)|vaccine group difference|19.0|||||TWO_SIDED|95.0|12.9|24.6|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||24.6|12.9|
71769445|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Vaccine group difference|28.0|||||TWO_SIDED|95.0|17.9|37.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.8|17.9|
71722815|NCT01942668|142962894|SUPERIORITY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|3.01||0.24|TWO_SIDED|95.0|-2.37|9.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||9.46|-2.37|0.240
71722816|NCT01942668|142962894|SUPERIORITY||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|2.98||0.353|TWO_SIDED|95.0|-8.62|3.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.08|-8.62|0.353
71722817|NCT01942668|142962895|SUPERIORITY||Mean Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.16||0.007|TWO_SIDED|95.0|-14.75|-2.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.36|-14.75|0.007
71722818|NCT01942668|142962895|SUPERIORITY||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|3.11||0.227|TWO_SIDED|95.0|-9.86|2.35||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.35|-9.86|0.227
71887798|NCT02058147|143296803|SUPERIORITY_OR_OTHER||Difference in percentage|18.08|||<|0.0001|TWO_SIDED|95.0|12.15|24.01||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8%, ≥8%) and randomization strata of second OAD use at screening.||24.01|12.15|<0.0001
71722819|NCT01942668|142962895|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.12||0.597|TWO_SIDED|95.0|-7.77|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||4.47|-7.77|0.597
71722820|NCT01942668|142962895|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|3.08||0.019|TWO_SIDED|95.0|-13.28|-1.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.19|-13.28|0.019
71722821|NCT01942668|142962896|SUPERIORITY||Mean Difference (Final Values)|-12.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-19.29|<0.001
71722822|NCT01942668|142962896|SUPERIORITY||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|3.25||0.013|TWO_SIDED|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.68|-14.46|0.013
71722823|NCT01942668|142962896|SUPERIORITY||Mean Difference (Final Values)|-4.81|STANDARD_ERROR_OF_MEAN|3.26||0.141|TWO_SIDED|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.59|-11.21|0.141
71722824|NCT01942668|142962896|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.22||0.001|TWO_SIDED|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.08|-16.73|0.001
71722825|NCT01942668|142962897|SUPERIORITY||Mean Difference (Final Values)|-15.59|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-22.16|-9.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.02|-22.16|<0.001
71722826|NCT01942668|142962897|SUPERIORITY||Mean Difference (Final Values)|-9.88|STANDARD_ERROR_OF_MEAN|3.29||0.003|TWO_SIDED|95.0|-16.34|-3.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.41|-16.34|0.003
71722827|NCT01942668|142962897|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.31||0.075|TWO_SIDED|95.0|-12.4|0.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.59|-12.40|0.075
71722828|NCT01942668|142962897|SUPERIORITY||Mean Difference (Final Values)|-12.05|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-18.47|-5.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.64|-18.47|<0.001
71722829|NCT01942668|142962898|SUPERIORITY||Mean Difference (Final Values)|-17.87|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.57|-11.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.05|-24.57|<0.001
71722830|NCT01942668|142962898|SUPERIORITY||Mean Difference (Final Values)|-11.35|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-18.0|-4.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.70|-18.00|<0.001
71887799|NCT02058147|143296804|SUPERIORITY_OR_OTHER||Difference in percentage|12.98|||<|0.0001|TWO_SIDED|95.0|7.5|18.45||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (\<8.0%, ≥8.0%) and randomization strata of second OAD use at screening.||18.45|7.5|< 0.0001
71722831|NCT01942668|142962898|SUPERIORITY||Mean Difference (Final Values)|-7.82|STANDARD_ERROR_OF_MEAN|3.4||0.022|TWO_SIDED|95.0|-14.5|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.14|-14.50|0.022
71722832|NCT01942668|142962898|SUPERIORITY||Mean Difference (Final Values)|-12.51|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.11|-5.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.91|-19.11|<0.001
71722833|NCT01942668|142962899|SUPERIORITY||Mean Difference (Final Values)|-17.75|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-24.45|-11.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.06|-24.45|<0.001
71887800|NCT02058147|143296805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.99||0.4857|TWO_SIDED|95.0|-2.632|1.252||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects.||1.252|-2.632|0.4857
71722834|NCT01942668|142962899|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-19.88|-6.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.70|-19.88|<0.001
71722835|NCT01942668|142962899|SUPERIORITY||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|3.37||0.003|TWO_SIDED|95.0|-16.83|-3.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.60|-16.83|0.003
71722836|NCT01942668|142962899|SUPERIORITY||Mean Difference (Final Values)|-13.61|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-20.15|-7.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.07|-20.15|<0.001
71722837|NCT01942668|142962900|SUPERIORITY||Mean Difference (Final Values)|-16.63|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.35|-9.91||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.91|-23.35|<0.001
71722838|NCT01942668|142962900|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.58|-6.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.36|-19.58|<0.001
71722839|NCT01942668|142962900|SUPERIORITY||Mean Difference (Final Values)|-9.63|STANDARD_ERROR_OF_MEAN|3.38||0.005|TWO_SIDED|95.0|-16.27|-2.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-2.99|-16.27|0.005
71722840|NCT01942668|142962900|SUPERIORITY||Mean Difference (Final Values)|-11.97|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-18.53|-5.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.41|-18.53|<0.001
71722841|NCT01942668|142962901|SUPERIORITY||Mean Difference (Final Values)|-17.12|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.79|-10.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.44|-23.79|<0.001
71722842|NCT01942668|142962901|SUPERIORITY||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-22.15|-9.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.01|-22.15|<0.001
71722843|NCT01942668|142962901|SUPERIORITY||Mean Difference (Final Values)|-11.05|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.65|-4.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.44|-17.65|0.001
71722844|NCT01942668|142962901|SUPERIORITY||Mean Difference (Final Values)|-13.02|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-19.54|-6.5||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.50|-19.54|<0.001
71722845|NCT01942668|142962902|SUPERIORITY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-23.58|-10.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.03|-23.58|<0.001
71887801|NCT00820573|143296812|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"A general unstructured variance-covariance matrix (ANOVA) was applied for measurements at different periods. Between-group comparisons after 6 wks of treatment were assessed using the ANOVA model at alpha=0.05 (two-sided).~16 subjects provide \~90% power to detect difference in EGP of 0.28 mg/kg.min (95% CI = 0.17 mg/kg.min)."||||<0.05
71722846|NCT01942668|142962902|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-22.32|-8.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.99|-22.32|<0.001
71722847|NCT01942668|142962902|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|3.41||0.001|TWO_SIDED|95.0|-17.9|-4.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.49|-17.90|0.001
71722848|NCT01942668|142962902|SUPERIORITY||Mean Difference (Final Values)|-12.16|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-18.78|-5.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.55|-18.78|<0.001
71722849|NCT01942668|142962903|SUPERIORITY||Mean Difference (Final Values)|-18.11|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-24.92|-11.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.29|-24.92|<0.001
71722850|NCT01942668|142962903|SUPERIORITY||Mean Difference (Final Values)|-16.45|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-23.17|-9.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.74|-23.17|<0.001
71722851|NCT01942668|142962903|SUPERIORITY||Mean Difference (Final Values)|-12.41|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-19.15|-5.66||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.66|-19.15|<0.001
71722852|NCT01942668|142962903|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-20.26|-6.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.93|-20.26|<0.001
71722853|NCT01942668|142962904|SUPERIORITY||Mean Difference (Final Values)|-16.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-9.82|-23.33|<0.001
71722854|NCT01942668|142962904|SUPERIORITY||Mean Difference (Final Values)|-15.07|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.42|-21.72|<0.001
71722855|NCT01942668|142962904|SUPERIORITY||Mean Difference (Final Values)|-10.79|STANDARD_ERROR_OF_MEAN|3.41||0.002|TWO_SIDED|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.10|-17.48|0.002
71722856|NCT01942668|142962904|SUPERIORITY||Mean Difference (Final Values)|-11.71|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.11|-18.31|<0.001
71722857|NCT01942668|142962905|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.034||0.801|TWO_SIDED|95.0|-0.06|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.06|0.801
71722858|NCT01942668|142962905|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.991|TWO_SIDED|95.0|-0.07|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.07|0.991
71722859|NCT01942668|142962905|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.034||0.642|TWO_SIDED|95.0|-0.05|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.05|0.642
71722860|NCT01942668|142962905|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.034||0.928|TWO_SIDED|95.0|-0.07|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.07|0.928
71722861|NCT01942668|142962906|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.043||0.231|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.231
71722862|NCT01942668|142962906|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.042||0.173|TWO_SIDED|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.14|0.173
71722863|NCT01942668|142962906|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.042||0.717|TWO_SIDED|95.0|-0.07|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.07|0.717
71722864|NCT01942668|142962906|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.849|TWO_SIDED|95.0|-0.09|0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.09|0.849
71722865|NCT01942668|142962907|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.039|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.039
71887802|NCT00820573|143296813|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||multivariate analysis was performed to compare results amongst all four groups||||<0.05
71887803|NCT00820573|143296814|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||ANOVA||||0.05
71722866|NCT01942668|142962907|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.03|TWO_SIDED|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.21|0.030
71722867|NCT01942668|142962907|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.052||0.946|TWO_SIDED|95.0|-0.1|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.10|0.946
71722868|NCT01942668|142962907|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.051||0.309|TWO_SIDED|95.0|-0.15|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.15|0.309
71722869|NCT01942668|142962908|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.061||0.031|TWO_SIDED|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.25|0.031
71722870|NCT01942668|142962908|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.005|TWO_SIDED|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.05|-0.28|0.005
71722871|NCT01942668|142962908|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.401|TWO_SIDED|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.17|0.401
71722872|NCT01942668|142962908|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.059||0.1|TWO_SIDED|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.21|0.100
71722873|NCT01942668|142962909|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.071||0.001|TWO_SIDED|95.0|-0.37|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.37|0.001
71829891|NCT02709655|143164068|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|1.24||0.0937|TWO_SIDED|95.0|-4.54|0.36|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.36|-4.54|0.0937
71887804|NCT00820573|143296815|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71722874|NCT01942668|142962909|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.034|TWO_SIDED|95.0|-0.28|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.28|0.034
71722875|NCT01942668|142962909|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED|95.0|-0.16|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.16|0.790
71722876|NCT01942668|142962909|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.069||0.086|TWO_SIDED|95.0|-0.25|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.25|0.086
71722877|NCT01942668|142962910|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
71722878|NCT01942668|142962910|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.083||0.03|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.030
71722879|NCT01942668|142962910|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.083||0.247|TWO_SIDED|95.0|-0.26|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.26|0.247
71722880|NCT01942668|142962910|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.022|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.022
71722881|NCT01942668|142962911|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
71722882|NCT01942668|142962911|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.083||0.002|TWO_SIDED|95.0|-0.42|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.42|0.002
71722883|NCT01942668|142962911|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.084||0.031|TWO_SIDED|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.34|0.031
71887805|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71722884|NCT01942668|142962911|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.016|TWO_SIDED|95.0|-0.36|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.36|0.016
71722885|NCT01942668|142962912|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
71722886|NCT01942668|142962912|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.086||0.008|TWO_SIDED|95.0|-0.4|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.40|0.008
71722887|NCT01942668|142962912|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.086||0.087|TWO_SIDED|95.0|-0.32|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.32|0.087
71722888|NCT01942668|142962912|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.085||0.092|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.092
71722889|NCT01942668|142962913|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
71722890|NCT01942668|142962913|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.09||0.001|TWO_SIDED|95.0|-0.47|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.12|-0.47|0.001
71887806|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71722891|NCT01942668|142962913|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.091||0.009|TWO_SIDED|95.0|-0.42|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.42|0.009
71722892|NCT01942668|142962913|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.007|TWO_SIDED|95.0|-0.42|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.42|0.007
71722893|NCT01942668|142962914|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
71722894|NCT01942668|142962914|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.094||0.003|TWO_SIDED|95.0|-0.46|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.46|0.003
71722895|NCT01942668|142962914|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.095||0.016|TWO_SIDED|95.0|-0.41|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.41|0.016
71722896|NCT01942668|142962914|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.31|TWO_SIDED|95.0|-0.28|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.28|0.310
71769446|NCT02446743|143039188|OTHER|Vaccine comparison at 1 month after booster /1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Vaccine group difference|13.0|||||TWO_SIDED|95.0|6.4|20.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.1|6.4|
71769447|NCT02446743|143039189|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.11|3.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.20|2.11|
71769448|NCT02446743|143039189|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|8.85|15.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||15|8.85|
71722897|NCT01942668|142962915|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
71722898|NCT01942668|142962915|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.56|-0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.19|-0.56|<0.001
71722899|NCT01942668|142962915|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.097||0.011|TWO_SIDED|95.0|-0.44|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.06|-0.44|0.011
71887807|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71887808|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71722900|NCT01942668|142962915|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.076|TWO_SIDED|95.0|-0.36|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.36|0.076
71722901|NCT01942668|142962916|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.38|-0.77|<0.001
71722902|NCT01942668|142962916|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.59|<0.001
71722903|NCT01942668|142962916|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.018|TWO_SIDED|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.43|0.018
71722904|NCT01942668|142962916|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.098||0.096|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.096
71722905|NCT01942668|142962917|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|2.88||0.865|TWO_SIDED|95.0|-5.16|6.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.14|-5.16|0.865
71722906|NCT01942668|142962917|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|2.83||0.847|TWO_SIDED|95.0|-5.01|6.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.10|-5.01|0.847
71722907|NCT01942668|142962917|SUPERIORITY||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.85||0.463|TWO_SIDED|95.0|-3.5|7.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||7.68|-3.50|0.463
71722908|NCT01942668|142962917|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|2.81||0.207|TWO_SIDED|95.0|-9.07|1.97||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.97|-9.07|0.207
71722909|NCT01942668|142962918|SUPERIORITY||Mean Difference (Final Values)|-5.07|STANDARD_ERROR_OF_MEAN|3.43||0.14|TWO_SIDED|95.0|-11.8|1.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||1.67|-11.80|0.140
71722910|NCT01942668|142962918|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|3.38||0.982|TWO_SIDED|95.0|-6.7|6.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||6.55|-6.70|0.982
71769449|NCT02446743|143039189|OTHER|Vaccine comparison-Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.18|||||TWO_SIDED|95.0|1.7|2.79|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.79|1.70|
71722911|NCT01942668|142962918|SUPERIORITY||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|3.39||0.492|TWO_SIDED|95.0|-4.32|8.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||8.98|-4.32|0.492
71769450|NCT02446743|143039189|OTHER|Vaccine comparison-post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|12.0|||||TWO_SIDED|95.0|8.22|17.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||17|8.22|
71769451|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|3.04|||||TWO_SIDED|95.0|2.2|4.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.20|2.20|
71769452|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|11.0|||||TWO_SIDED|95.0|7.75|16.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||16|7.75|
71722912|NCT01942668|142962918|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|3.35||0.216|TWO_SIDED|95.0|-10.72|2.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.43|-10.72|0.216
71722913|NCT01942668|142962919|SUPERIORITY||Mean Difference (Final Values)|-10.38|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.26|-3.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.50|-17.26|0.003
71722914|NCT01942668|142962919|SUPERIORITY||Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|3.45||0.277|TWO_SIDED|95.0|-10.53|3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.02|-10.53|0.277
71722915|NCT01942668|142962919|SUPERIORITY||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|3.46||0.394|TWO_SIDED|95.0|-9.75|3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||3.84|-9.75|0.394
71769453|NCT02446743|143039189|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|16.0|||||TWO_SIDED|95.0|12.0|21.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||21|12|
71722916|NCT01942668|142962919|SUPERIORITY||Mean Difference (Final Values)|-7.86|STANDARD_ERROR_OF_MEAN|3.42||0.022|TWO_SIDED|95.0|-14.58|-1.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.15|-14.58|0.022
71722917|NCT01942668|142962920|SUPERIORITY||Mean Difference (Final Values)|-15.32|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.75|-7.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.89|-22.75|<0.001
71722918|NCT01942668|142962920|SUPERIORITY||Mean Difference (Final Values)|-8.92|STANDARD_ERROR_OF_MEAN|3.73||0.017|TWO_SIDED|95.0|-16.24|-1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-1.60|-16.24|0.017
71722919|NCT01942668|142962920|SUPERIORITY||Mean Difference (Final Values)|-4.56|STANDARD_ERROR_OF_MEAN|3.74||0.223|TWO_SIDED|95.0|-11.9|2.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||2.78|-11.90|0.223
71722920|NCT01942668|142962920|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|3.69||0.002|TWO_SIDED|95.0|-18.57|-4.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.07|-18.57|0.002
71769454|NCT02446743|143039189|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|68.0|||||TWO_SIDED|95.0|51.0|90.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||90|51|
71769455|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|18.0|||||TWO_SIDED|95.0|13.0|26.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||26|13|
71769456|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|74.0|||||TWO_SIDED|95.0|51.0|107.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||107|51|
71769457|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|14.0|||||TWO_SIDED|95.0|8.99|22.0|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||22|8.99|
71769458|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|63.0|||||TWO_SIDED|95.0|41.0|95.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||95|41|
71769459|NCT02446743|143039189|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.24|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|1.24|
71769460|NCT02446743|143039189|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|5.9|||||TWO_SIDED|95.0|4.49|7.76|||ANOVA|||Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||7.76|4.49|
71722921|NCT01942668|142962921|SUPERIORITY||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-24.65|-10.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.28|-24.65|<0.001
71722922|NCT01942668|142962921|SUPERIORITY||Mean Difference (Final Values)|-10.26|STANDARD_ERROR_OF_MEAN|3.6||0.005|TWO_SIDED|95.0|-17.33|-3.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-3.18|-17.33|0.005
71722923|NCT01942668|142962921|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.62||0.087|TWO_SIDED|95.0|-13.31|0.89||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.89|-13.31|0.087
71829892|NCT02709655|143164068|OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.44||0.2336|TWO_SIDED|95.0|-4.56|1.11|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||1.11|-4.56|0.2336
71829893|NCT02709655|143164068|OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|1.44||0.0879|TWO_SIDED|95.0|-5.29|0.37|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.37|-5.29|0.0879
71829894|NCT02709655|143164068|OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.7||0.0531|TWO_SIDED|95.0|-6.65|0.04|||Mixed Models Analysis|||Analysis was performed using an REML-based MMRM approach with freely varying mean and covariance structure and with country, treatment (vortioxetine 10 mg/day, vortioxetine 20 mg/day, fluoxetine, and placebo), and Week as fixed factors and Baseline CDRS-R total score as a continuous covariate, the treatment-by-week interaction, and Baseline CDRS-R-by-Week interaction.||0.04|-6.65|0.0531
71829895|NCT00102063|143164089|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
71829896|NCT00102063|143164089|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
71829897|NCT00857649|143164129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.52||0.418|TWO_SIDED|95.0|-1.75|4.21|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||4.21|-1.75|0.418
71829898|NCT00857649|143164130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.92||0.603|TWO_SIDED|95.0|-2.3|1.34|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||1.34|-2.30|0.603
71829899|NCT00857649|143164131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.734|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||0.31|-0.22|0.734
71829900|NCT00857649|143164132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.017|TWO_SIDED|95.0|-3.29|-0.32|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||-0.32|-3.29|0.017
71887809|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.0|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71722924|NCT01942668|142962921|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-19.68|-5.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.65|-19.68|<0.001
71722925|NCT01942668|142962922|SUPERIORITY||Mean Difference (Final Values)|-20.32|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-27.77|-12.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.87|-27.77|<0.001
71722926|NCT01942668|142962922|SUPERIORITY||Mean Difference (Final Values)|-12.61|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-19.95|-5.28||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.28|-19.95|<0.001
71722927|NCT01942668|142962922|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|3.75||0.027|TWO_SIDED|95.0|-15.7|-0.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.96|-15.70|0.027
71829901|NCT00857649|143164133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.98||0.36|TWO_SIDED|95.0|-1.03|2.83|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.||||2.83|-1.03|0.360
71829902|NCT05190419|143164134|SUPERIORITY||Mean Difference (Net)|-35.4|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-54.7|-16.0||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-16.0|-54.7|<0.001
71829903|NCT05190419|143164134|SUPERIORITY||Mean Difference (Net)|-43.9|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-63.1|-24.8||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-24.8|-63.1|<0.001
71887810|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.003|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0|||
71722928|NCT01942668|142962922|SUPERIORITY||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-21.13|-6.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.58|-21.13|<0.001
71722929|NCT01942668|142962923|SUPERIORITY||Mean Difference (Final Values)|-21.45|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-28.87|-14.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.04|-28.87|<0.001
71887811|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.035|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.001|||
71887812|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.176|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.018|||
71887813|NCT03604445|143296819|OTHER||Probability of DLT rate in [0.16, 0.33)|0.129|||||||||||||Posterior probabilities of the DLT rate lying in the intervals \[0.16, 0.33) (target dosing), and \[0.33,1\] (overdosing) are reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.|Probability of DLT rate in \[0.33, 1\] = 0.83|||
71887814|NCT01360645|143296828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0001|TWO_SIDED|95.0|-4.7|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-1.54|-4.70|0.0001
71887815|NCT01360645|143296829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21||||0.0002|TWO_SIDED|95.0|-4.87|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-1.54|-4.87|0.0002
71887816|NCT01360645|143296830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0372|TWO_SIDED|95.0|-0.86|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.86|0.0372
71887817|NCT01360645|143296831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0349|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||||-0.03|-0.88|0.0349
71887818|NCT01360645|143296832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.008|TWO_SIDED|95.0|-2.25|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.25|0.0080
71657343|NCT02504671|142831740|OTHER||Mean Difference (Net)|-2.51||||0.518|TWO_SIDED|95.0|-10.13|5.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.12|-10.13|0.518
71722930|NCT01942668|142962923|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-23.39|-8.8||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.80|-23.39|<0.001
71722931|NCT01942668|142962923|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_ERROR_OF_MEAN|3.73||0.001|TWO_SIDED|95.0|-19.34|-4.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.68|-19.34|0.001
71887819|NCT01360645|143296832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.0045|TWO_SIDED|95.0|-2.91|-0.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.54|-2.91|0.0045
71887820|NCT01360645|143296832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.0001|TWO_SIDED|95.0|-3.96|-1.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.30|-3.96|0.0001
71887821|NCT01360645|143296832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.0004|TWO_SIDED|95.0|-4.01|-1.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.18|-4.01|0.0004
71887822|NCT01360645|143296832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.19||||0|TWO_SIDED|95.0|-4.68|-1.7|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-1.70|-4.68|0.0000
71887823|NCT01360645|143296833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0086|TWO_SIDED|95.0|-2.28|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.34|-2.28|0.0086
71887824|NCT01360645|143296833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0149|TWO_SIDED|95.0|-2.74|-0.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.30|-2.74|0.0149
71887825|NCT01360645|143296833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.0006|TWO_SIDED|95.0|-3.78|-1.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-1.05|-3.78|0.0006
71887826|NCT01360645|143296833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.0009|TWO_SIDED|95.0|-4.0|-1.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-1.04|-4.00|0.0009
71722932|NCT01942668|142962923|SUPERIORITY||Mean Difference (Final Values)|-15.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-22.97|-8.49||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.49|-22.97|<0.001
71722933|NCT01942668|142962924|SUPERIORITY||Mean Difference (Final Values)|-20.52|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-28.06|-12.97||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.97|-28.06|<0.001
71769461|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.13|1.54|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.54|1.13|
71722934|NCT01942668|142962924|SUPERIORITY||Mean Difference (Final Values)|-15.37|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-22.8|-7.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.95|-22.80|<0.001
71722935|NCT01942668|142962924|SUPERIORITY||Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|3.8||0.003|TWO_SIDED|95.0|-18.95|-4.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.03|-18.95|0.003
71769462|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|8.27|||||TWO_SIDED|95.0|5.83|12.0|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||12|5.83|
71769463|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.64|||||TWO_SIDED|95.0|1.22|2.2|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.20|1.22|
71769464|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|4.36|||||TWO_SIDED|95.0|2.88|6.58|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||6.58|2.88|
71769465|NCT02446743|143039189|OTHER|"Vaccine comparison Pre-booster or pre-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|1.3|||||TWO_SIDED|95.0|0.97|1.75|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||1.75|0.97|
71769466|NCT02446743|143039189|OTHER|"Vaccine comparison Post-booster or post-1st dose in V72\_75 (Group 3B vs. Group B~\_0\_1)"|Ratio of GMTs|2.6|||||TWO_SIDED|95.0|2.08|3.25|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.25|2.08|
71769467|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.9|2.18|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.18|0.90|
71769468|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\]|Ratio of GMTs|2.79|||||TWO_SIDED|95.0|2.04|3.81|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.81|2.04|
71769469|NCT02446743|143039189|OTHER|Vaccine comparison- Pre-booster or pre-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|0.82|1.82|||ANOVA|||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||1.82|0.82|
71769470|NCT02446743|143039189|OTHER|Vaccine comparison- post-booster or post-1st dose in V72\_75 \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\]|Ratio of GMTs|2.45|||||TWO_SIDED|95.0|1.79|3.36|||ANOVA|||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.79|
71769471|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.7|33.0|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.0|20.7|
71769472|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|29.0|||||TWO_SIDED|95.0|19.3|38.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||38.7|19.3|
71722936|NCT01942668|142962924|SUPERIORITY||Mean Difference (Final Values)|-13.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-21.19|-6.46||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.46|-21.19|<0.001
71722937|NCT01942668|142962925|SUPERIORITY||Mean Difference (Final Values)|-20.34|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-27.93|-12.74||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.74|-27.93|<0.001
71722938|NCT01942668|142962925|SUPERIORITY||Mean Difference (Final Values)|-17.92|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-25.39|-10.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.45|-25.39|<0.001
71722939|NCT01942668|142962925|SUPERIORITY||Mean Difference (Final Values)|-12.97|STANDARD_ERROR_OF_MEAN|3.82|<|0.001|TWO_SIDED|95.0|-20.49|-5.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.46|-20.49|<0.001
71722940|NCT01942668|142962925|SUPERIORITY||Mean Difference (Final Values)|-14.28|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-21.7|-6.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.87|-21.70|<0.001
71722941|NCT01942668|142962926|SUPERIORITY||Mean Difference (Final Values)|-21.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.72|-13.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-13.29|-28.72|<0.001
71722942|NCT01942668|142962926|SUPERIORITY||Mean Difference (Final Values)|-18.37|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.96|-10.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.78|-25.96|<0.001
71722943|NCT01942668|142962926|SUPERIORITY||Mean Difference (Final Values)|-13.03|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-20.66|-5.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-5.39|-20.66|<0.001
71722944|NCT01942668|142962926|SUPERIORITY||Mean Difference (Final Values)|-14.65|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-22.19|-7.12||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-7.12|-22.19|<0.001
71722945|NCT01942668|142962927|SUPERIORITY||Mean Difference (Final Values)|-21.83|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|-29.57|-14.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-14.08|-29.57|<0.001
71722946|NCT01942668|142962927|SUPERIORITY||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-27.02|-11.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-11.77|-27.02|<0.001
71722947|NCT01942668|142962927|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-21.65|-6.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.32|-21.65|<0.001
71722948|NCT01942668|142962927|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-23.23|-8.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-8.10|-23.23|<0.001
71722949|NCT01942668|142962928|SUPERIORITY||Mean Difference (Final Values)|-20.61|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-28.32|-12.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-12.89|-28.32|<0.001
71722950|NCT01942668|142962928|SUPERIORITY||Mean Difference (Final Values)|-18.24|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-25.84|-10.65||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-10.65|-25.84|<0.001
71769473|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|26.0|||||TWO_SIDED|95.0|18.3|33.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||33.9|18.3|
71769474|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|15.9|27.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen||27.9|15.9|
71769475|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|19.0|||||TWO_SIDED|95.0|11.5|28.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.5|11.5|
71769476|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.6|31.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.9|14.6|
71829904|NCT05190419|143164134|SUPERIORITY||Mean Difference (Net)|-46.4|STANDARD_ERROR_OF_MEAN|9.75|<|0.001|TWO_SIDED|95.0|-65.6|-27.3||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|ANCOVA|p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.||||-27.3|-65.6|<0.001
71722951|NCT01942668|142962928|SUPERIORITY||Mean Difference (Final Values)|-12.62|STANDARD_ERROR_OF_MEAN|3.89||0.001|TWO_SIDED|95.0|-20.26|-4.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-4.98|-20.26|0.001
71722952|NCT01942668|142962928|SUPERIORITY||Mean Difference (Final Values)|-13.97|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-21.51|-6.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-6.43|-21.51|<0.001
71769477|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|38.0|||||TWO_SIDED|95.0|29.8|45.4|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.4|29.8|
71769478|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|55.0|||||TWO_SIDED|95.0|43.5|64.7|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||64.7|43.5|
71769479|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.9|35.1|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.1|12.9|
71769480|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|23.0|||||TWO_SIDED|95.0|14.7|30.8|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||30.8|14.7|
71769481|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41) Difference|Vaccine group difference|24.0|||||TWO_SIDED|95.0|12.2|35.5|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||35.5|12.2|
71769482|NCT02446743|143039191|OTHER|1 month post booster/first dose of vaccination: Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10) Difference|Vaccine group difference|22.0|||||TWO_SIDED|95.0|10.6|32.9|||Miettinen and Nurminen score method|||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.9|10.6|
71769483|NCT02446743|143039192|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.0|4.5||Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4.5|-15.0|
71722953|NCT01942668|142962929|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.027||0.676|TWO_SIDED|95.0|-0.04|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.04|0.676
71829905|NCT05323734|143164190|OTHER||Median Difference (Final Values)|-14.53||||0.0904|TWO_SIDED|95.0|-32.04|2.48|||Wilcoxon Rank-Sum|Wilcoxon Rank-Sum statistic is applied using a 2-sided significance level of 0.05.|The Hodges-Lehmann approach is applied for estimating 95% confidence interval.|||2.48|-32.04|0.0904
71829906|NCT05323734|143164191|OTHER||Difference in percentage|6.4||||0.3407|TWO_SIDED|95.0|-6.4|20.1|||Fisher Exact|||||20.1|-6.4|0.3407
71829907|NCT05323734|143164192|OTHER||Odds Ratio (OR)|0.88||||0.7069|TWO_SIDED|95.0|0.46|1.7|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.70|0.46|0.7069
71829908|NCT05323734|143164193|OTHER||Odds Ratio (OR)|0.85||||0.6434|TWO_SIDED|95.0|0.42|1.72|||Regression, Logistic||The estimated odds ratio of the ganaxolone group compared to the placebo group based on proportional odds logistic regression with treatment as a factor.|||1.72|0.42|0.6434
71722954|NCT01942668|142962929|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.027||0.436|TWO_SIDED|95.0|-0.03|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.07|-0.03|0.436
71829909|NCT02486718|143164194|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.848||||0.0683|TWO_SIDED|95.0|0.71|1.013|||Log Rank|||||1.013|0.710|0.0683
71722955|NCT01942668|142962929|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.027||0.106|TWO_SIDED|95.0|-0.01|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.10|-0.01|0.106
71722956|NCT01942668|142962929|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.752|TWO_SIDED|95.0|-0.06|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.06|0.752
71722957|NCT01942668|142962930|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.038||0.193|TWO_SIDED|95.0|-0.12|0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.12|0.193
71829910|NCT02486718|143164195|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.691|0.998||||||||0.998|0.691|
71829911|NCT02486718|143164196|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.704|||||TWO_SIDED|95.0|0.545|0.91||||||||0.910|0.545|
71829912|NCT02486718|143164198|SUPERIORITY||Difference in event-free rates|5.98|||||TWO_SIDED|95.0|-0.28|12.23||||||||12.23|-0.28|
71722958|NCT01942668|142962930|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.037||0.319|TWO_SIDED|95.0|-0.11|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.11|0.319
71722959|NCT01942668|142962930|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.037||0.239|TWO_SIDED|95.0|-0.03|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.12|-0.03|0.239
71829913|NCT02486718|143164199|SUPERIORITY||Difference in event-free rates|6.65|||||TWO_SIDED|95.0|-0.06|13.36||||||||13.36|-0.06|
71722960|NCT01942668|142962930|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.72|TWO_SIDED|95.0|-0.09|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.06|-0.09|0.720
71722961|NCT01942668|142962931|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.049||0.03|TWO_SIDED|95.0|-0.2|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.20|0.030
71722962|NCT01942668|142962931|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.048||0.06|TWO_SIDED|95.0|-0.19|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.19|0.060
71722963|NCT01942668|142962931|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.048||0.506|TWO_SIDED|95.0|-0.06|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.13|-0.06|0.506
71769484|NCT02446743|143039192|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-17.0|11.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.4|-17.0|
71769485|NCT02446743|143039192|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-8.0|||||TWO_SIDED|95.0|-20.0|7.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||7.3|-20.0|
71769486|NCT02446743|143039192|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||6.2|-0.9|
71769487|NCT02446743|143039192|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
71829914|NCT02486718|143164200|SUPERIORITY||Difference in event-free rates|10.67|||||TWO_SIDED|95.0|1.56|19.79||||||||19.79|1.56|
71722964|NCT01942668|142962931|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.048||0.232|TWO_SIDED|95.0|-0.15|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.04|-0.15|0.232
71722965|NCT01942668|142962932|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.058||0.027|TWO_SIDED|95.0|-0.24|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.24|0.027
71722966|NCT01942668|142962932|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.057||0.011|TWO_SIDED|95.0|-0.26|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.26|0.011
71722967|NCT01942668|142962932|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.057||0.71|TWO_SIDED|95.0|-0.13|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.13|0.710
71722968|NCT01942668|142962932|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.057||0.072|TWO_SIDED|95.0|-0.21|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.21|0.072
71722969|NCT01942668|142962933|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.36|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.09|-0.36|<0.001
71722970|NCT01942668|142962933|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.068||0.062|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.062
71722971|NCT01942668|142962933|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.068||0.886|TWO_SIDED|95.0|-0.12|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.14|-0.12|0.886
71829915|NCT02486718|143164201|SUPERIORITY||Difference in event-free rates|5.48|||||TWO_SIDED|95.0|-0.94|11.9||||||||11.90|-0.94|
71829916|NCT02486718|143164202|SUPERIORITY||Difference in event-free rates|4.88|||||TWO_SIDED|95.0|-1.94|11.7||||||||11.70|-1.94|
71829917|NCT02486718|143164203|SUPERIORITY||Difference in event-free rates|10.46|||||TWO_SIDED|95.0|1.16|19.76||||||||19.76|1.16|
71829918|NCT02486718|143164204|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.503|||||TWO_SIDED|95.0|0.332|0.761||||||||0.761|0.332|
71722972|NCT01942668|142962933|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.067|TWO_SIDED|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.26|0.067
71722973|NCT01942668|142962934|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.53|<0.001
71722974|NCT01942668|142962934|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.082||0.053|TWO_SIDED|95.0|-0.32|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.00|-0.32|0.053
71722975|NCT01942668|142962934|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.083||0.413|TWO_SIDED|95.0|-0.23|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.09|-0.23|0.413
71722976|NCT01942668|142962934|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.082||0.018|TWO_SIDED|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.35|0.018
71722977|NCT01942668|142962935|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.20|-0.54|<0.001
71722978|NCT01942668|142962935|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.083||0.006|TWO_SIDED|95.0|-0.4|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.40|0.006
71829919|NCT05061693|143164209|SUPERIORITY||Odds Ratio (OR)|7.1||||0.0061|TWO_SIDED|95.0|1.6|45.4|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||45.4|1.6|0.0061
71722979|NCT01942668|142962935|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.084||0.072|TWO_SIDED|95.0|-0.32|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.32|0.072
71722980|NCT01942668|142962935|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.083||0.014|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.014
71722981|NCT01942668|142962936|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.21|-0.55|<0.001
71829920|NCT05061693|143164209|SUPERIORITY||difference in response rate|28.0|STANDARD_ERROR_OF_MEAN|9.18|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
71722982|NCT01942668|142962936|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.085||0.016|TWO_SIDED|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.04|-0.37|0.016
71722983|NCT01942668|142962936|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.169|TWO_SIDED|95.0|-0.29|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.05|-0.29|0.169
71722984|NCT01942668|142962936|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.085||0.081|TWO_SIDED|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.02|-0.31|0.081
71722985|NCT01942668|142962937|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.092|<|0.001|TWO_SIDED|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.30|-0.66|<0.001
71722986|NCT01942668|142962937|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.003|TWO_SIDED|95.0|-0.45|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.10|-0.45|0.003
71722987|NCT01942668|142962937|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.091||0.022|TWO_SIDED|95.0|-0.39|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.03|-0.39|0.022
71722988|NCT01942668|142962937|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.006|TWO_SIDED|95.0|-0.43|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.43|0.006
71722989|NCT01942668|142962938|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.33|-0.71|<0.001
71722990|NCT01942668|142962938|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.095||0.007|TWO_SIDED|95.0|-0.44|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.07|-0.44|0.007
71829921|NCT05061693|143164209|SUPERIORITY||Odds Ratio (OR)|10.2||||0.0005|TWO_SIDED|95.0|2.3|65.6|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||65.6|2.3|0.0005
71829922|NCT05061693|143164209|SUPERIORITY||difference in response rate|36.3|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
71722991|NCT01942668|142962938|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.095||0.038|TWO_SIDED|95.0|-0.39|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.39|0.038
71722992|NCT01942668|142962938|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.094||0.283|TWO_SIDED|95.0|-0.29|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.08|-0.29|0.283
71722993|NCT01942668|142962939|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.34|-0.72|<0.001
71722994|NCT01942668|142962939|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.54|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.16|-0.54|<0.001
71722995|NCT01942668|142962939|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.098||0.027|TWO_SIDED|95.0|-0.41|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.02|-0.41|0.027
71722996|NCT01942668|142962939|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.096||0.071|TWO_SIDED|95.0|-0.36|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.01|-0.36|0.071
71722997|NCT01942668|142962940|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.77|-0.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.37|-0.77|<0.001
71829923|NCT05061693|143164209|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|3.9|107.5|||Regression, Logistic|Exact Logistic regression: (response at Week 16 = treatment + stratification factor \[Day 1 Investigator's Global Assessment score (3 or 4)\])||||107.5|3.9|<0.0001
71829924|NCT05061693|143164209|SUPERIORITY||difference in response rate|48.6|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|||||||The standard error of the difference between response rates was from normal approximation.|||||
71657344|NCT02504671|142831740|OTHER||Mean Difference (Net)|-2.0||||0.599|TWO_SIDED|95.0|-9.5|5.49||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12|||5.49|-9.50|0.599
71722998|NCT01942668|142962940|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.18|-0.57|<0.001
71722999|NCT01942668|142962940|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.039|TWO_SIDED|95.0|-0.4|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||-0.01|-0.40|0.039
71723000|NCT01942668|142962940|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.099||0.088|TWO_SIDED|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM|||0.03|-0.36|0.088
71723001|NCT01942668|142962941|SUPERIORITY|||||||0.85||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.850
71723002|NCT01942668|142962941|SUPERIORITY|||||||0.622||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.622
71723003|NCT01942668|142962941|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||1.000
71723004|NCT01942668|142962941|SUPERIORITY|||||||0.374||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.374
71723005|NCT01942668|142962941|SUPERIORITY|||||||0.706||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.706
71723006|NCT01942668|142962941|SUPERIORITY|||||||0.372||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.372
71723007|NCT01942668|142962941|SUPERIORITY|||||||0.316||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.316
71723008|NCT01942668|142962941|SUPERIORITY|||||||0.221||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.221
71723009|NCT01942668|142962942|SUPERIORITY|||||||0.283||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.283
71723010|NCT01942668|142962942|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.004
71723011|NCT01942668|142962942|SUPERIORITY|||||||0.68||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.680
71723012|NCT01942668|142962942|SUPERIORITY|||||||0.232||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.232
71829925|NCT01152190|143164218|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.121||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.121
71723013|NCT01942668|142962942|SUPERIORITY|||||||0.677||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.677
71829926|NCT01152190|143164219|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.226||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.226
71829927|NCT01152190|143164220|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.009||0.208||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.208
71829928|NCT01152190|143164220|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.066||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.066
71829929|NCT01152190|143164220|SUPERIORITY_OR_OTHER||Difference in LS Means|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.195||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.195
71829930|NCT01152190|143164220|SUPERIORITY_OR_OTHER||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.022||0.625||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.625
71887827|NCT01360645|143296833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28||||0|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-3.28|-4.84|0.0000
71887828|NCT01360645|143296834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0022|TWO_SIDED|95.0|-0.38|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.08|-0.38|0.0022
71887829|NCT01360645|143296834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0115|TWO_SIDED|95.0|-0.38|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.05|-0.38|0.0115
71887830|NCT01360645|143296834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.0255|TWO_SIDED|95.0|-0.41|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.03|-0.41|0.0255
71723014|NCT01942668|142962942|SUPERIORITY|||||||0.073||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.073
71829931|NCT01152190|143164221|SUPERIORITY_OR_OTHER||Difference in LS Means|2.63|STANDARD_ERROR_OF_MEAN|3.38||0.439||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.439
71829932|NCT01152190|143164221|SUPERIORITY_OR_OTHER||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|2.867||0.86||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.860
71723015|NCT01942668|142962942|SUPERIORITY|||||||0.301||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.301
71829933|NCT01152190|143164221|SUPERIORITY_OR_OTHER||Difference in LS Means|3.47|STANDARD_ERROR_OF_MEAN|2.937||0.24||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.240
71829934|NCT01152190|143164221|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|2.729||0.839||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.839
71829935|NCT01152190|143164221|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|5.77||0.468||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.468
71829936|NCT01152190|143164221|SUPERIORITY_OR_OTHER||Difference in LS Means|7.93|STANDARD_ERROR_OF_MEAN|5.199||0.131||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures|||||||0.131
71887831|NCT01360645|143296834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0005|TWO_SIDED|95.0|-0.57|-0.16|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.16|-0.57|0.0005
71887832|NCT01360645|143296834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.62|0.0001
71887833|NCT01360645|143296834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0005|TWO_SIDED|95.0|-0.6|-0.17|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.17|-0.60|0.0005
71887834|NCT01360645|143296835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 9||-0.10|-0.40|0.0010
71723016|NCT01942668|142962942|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.013
71723017|NCT01942668|142962943|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.003
71723018|NCT01942668|142962943|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
71723019|NCT01942668|142962943|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.135
71723020|NCT01942668|142962943|SUPERIORITY|||||||0.231||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.231
71723021|NCT01942668|142962943|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.377
71723022|NCT01942668|142962943|SUPERIORITY|||||||0.478||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.478
71723023|NCT01942668|142962943|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.015
71723024|NCT01942668|142962943|SUPERIORITY|||||||0.1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.100
71723025|NCT01942668|142962944|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71723026|NCT01942668|142962944|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71829937|NCT00442117|143164255|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.074||||0.4982|TWO_SIDED|95.0|-4.196|2.049|||ANOVA|||||2.049|-4.196|0.4982
71723027|NCT01942668|142962944|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.009
71723028|NCT01942668|142962944|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.017
71723029|NCT01942668|142962944|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.001
71723030|NCT01942668|142962944|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.025
71723031|NCT01942668|142962944|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71723032|NCT01942668|142962944|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71723033|NCT01942668|142962945|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
71723034|NCT01942668|142962945|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
71723035|NCT01942668|142962945|SUPERIORITY|||||||0.066||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.066
71723036|NCT01942668|142962945|SUPERIORITY|||||||0.055||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.055
71723037|NCT01942668|142962945|SUPERIORITY|||||||0.174||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.174
71723038|NCT01942668|142962945|SUPERIORITY|||||||0.319||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.319
71723039|NCT01942668|142962945|SUPERIORITY|||||||0.007||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.007
71829938|NCT00442117|143164256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7601||||0.6544|TWO_SIDED|95.0|-2.585|4.106|||ANOVA|||||4.106|-2.585|0.6544
71829939|NCT00442117|143164257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.704||||0.3796|TWO_SIDED|95.0|-5.528|2.115|||ANOVA|||||2.115|-5.528|0.3796
71829940|NCT00442117|143164258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.432||||0.9622|TWO_SIDED|95.0|-17.56|18.24|||ANOVA|||||18.240|-17.560|0.9622
71829941|NCT01579916|143164278|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference greater than or equal to 5 percentage points. This corresponds to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|Rate difference|-1.7|||||TWO_SIDED|95.0|-8.9|0.6|||Score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points||0.6|-8.9|
71829942|NCT01765543|143164303|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.614|||||TWO_SIDED|90.0|0.484|0.78||||||Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.780|0.484|
71829943|NCT01765543|143164304|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.596|||||TWO_SIDED|90.0|0.469|0.759||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||0.759|0.469|
71829944|NCT01765543|143164305|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.908|1.36||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.||1.36|0.908|
71723040|NCT01942668|142962945|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.008
71723041|NCT01942668|142962946|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
71723042|NCT01942668|142962946|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
71723043|NCT01942668|142962946|SUPERIORITY|||||||0.019||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.019
71723044|NCT01942668|142962946|SUPERIORITY|||||||0.061||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.061
71723045|NCT01942668|142962946|SUPERIORITY|||||||0.026||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.026
71829945|NCT03691428|143164330|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71723046|NCT01942668|142962946|SUPERIORITY|||||||0.104||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.104
71723047|NCT01942668|142962946|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
71723048|NCT01942668|142962946|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.018
71723049|NCT01942668|142962947|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
71723050|NCT01942668|142962947|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71723051|NCT01942668|142962947|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
71723052|NCT01942668|142962947|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.003
71723053|NCT01942668|142962947|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.017
71723054|NCT01942668|142962947|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.025
71723055|NCT01942668|142962947|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
71723056|NCT01942668|142962947|SUPERIORITY|||||||0.037||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||0.037
71723057|NCT01942668|142962948|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
71723058|NCT01942668|142962948|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
71723059|NCT01942668|142962948|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
71723060|NCT01942668|142962948|SUPERIORITY|||||||0.016||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.016
71723061|NCT01942668|142962948|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.012
71723062|NCT01942668|142962948|SUPERIORITY|||||||0.053||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.053
71829946|NCT03691428|143164331|SUPERIORITY|A multivariate dyadic linear growth curve model was used to predict the trajectories of psychological well-being (Raudenbush, Brennan, \& Barnett, 1995).|||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71829947|NCT03691428|143164332|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71723063|NCT01942668|142962948|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.004
71723064|NCT01942668|142962948|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.074
71723065|NCT01942668|142962949|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71723066|NCT01942668|142962949|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71723067|NCT01942668|142962949|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71723068|NCT01942668|142962949|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71723069|NCT01942668|142962949|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.009
71723070|NCT01942668|142962949|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.004
71829948|NCT03691428|143164333|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71829949|NCT03691428|143164334|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71657345|NCT02504671|142831740|OTHER||Mean Difference (Net)|-12.63||||0.015|TWO_SIDED|95.0|-22.78|-2.48||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-2.48|-22.78|0.015
71657346|NCT02504671|142831740|OTHER||Mean Difference (Net)|-17.18|||<|0.001|TWO_SIDED|95.0|-27.27|-7.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12|||-7.10|-27.27|<0.001
71657347|NCT02504671|142831740|OTHER||Mean Difference (Net)|-2.98||||0.054|TWO_SIDED|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||0.05|-6.00|0.054
71657348|NCT02504671|142831740|OTHER||Mean Difference (Net)|-6.04|||<|0.001|TWO_SIDED|95.0|-9.05|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12|||-3.02|-9.05|<0.001
71657349|NCT02504671|142831740|OTHER||Mean Difference (Net)|-3.63||||0.031|TWO_SIDED|95.0|-6.92|-0.33||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-0.33|-6.92|0.031
71657350|NCT02504671|142831740|OTHER||Mean Difference (Net)|-6.32|||<|0.001|TWO_SIDED|95.0|-9.61|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12|||-3.02|-9.61|<0.001
71723071|NCT01942668|142962949|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.002
71723072|NCT01942668|142962949|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||0.015
71723073|NCT01942668|142962950|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.004
71829950|NCT02527148|143164335|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the control cases||||<0.0001
71829951|NCT02527148|143164335|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 weeks for the Shapematch cases||||<0.0001
71657351|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71723074|NCT01942668|142962950|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71723075|NCT01942668|142962950|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.002
71723076|NCT01942668|142962950|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.001
71723077|NCT01942668|142962950|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
71723078|NCT01942668|142962950|SUPERIORITY|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.009
71723079|NCT01942668|142962950|SUPERIORITY|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.018
71723080|NCT01942668|142962950|SUPERIORITY|||||||0.021||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||0.021
71723081|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723082|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723083|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71829952|NCT02527148|143164335|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 weeks between both groups.||||0.0004
71829953|NCT02527148|143164335|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 6 months for Control cases.||||<0.0001
71829954|NCT02527148|143164335|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement form preoperative to 6 months for Shapematch cases.||||<0.0001
71829955|NCT02527148|143164335|SUPERIORITY|||||||0.3894|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 6 months between both groups.||||0.3894
71723084|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723085|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723086|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723087|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723088|NCT01942668|142962951|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723089|NCT01942668|142962952|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71887835|NCT01360645|143296835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.029|TWO_SIDED|95.0|-0.37|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10||-0.02|-0.37|0.0290
71657352|NCT02504671|142831741|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71723090|NCT01942668|142962952|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71723091|NCT01942668|142962952|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71723092|NCT01942668|142962952|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71723093|NCT01942668|142962952|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.006
71723094|NCT01942668|142962952|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.001
71723095|NCT01942668|142962952|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||0.015
71723096|NCT01942668|142962952|SUPERIORITY|||||||0.005||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.005
71723097|NCT01942668|142962953|SUPERIORITY|||||||0.523||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.523
71723098|NCT01942668|142962953|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
71723099|NCT01942668|142962953|SUPERIORITY|||||||0.821||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.821
71723100|NCT01942668|142962953|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
71723101|NCT01942668|142962953|SUPERIORITY|||||||0.828||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.828
71723102|NCT01942668|142962953|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||1.000
71723103|NCT01942668|142962953|SUPERIORITY|||||||0.239||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=50% Reduction||||0.239
71723104|NCT01942668|142962953|SUPERIORITY|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||\>=75% Reduction||||0.377
71723105|NCT01942668|142962954|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.036
71723106|NCT01942668|142962954|SUPERIORITY|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.015
71723107|NCT01942668|142962954|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||1.000
71723108|NCT01942668|142962954|SUPERIORITY|||||||0.546||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.546
71723109|NCT01942668|142962954|SUPERIORITY|||||||0.352||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.352
71723110|NCT01942668|142962954|SUPERIORITY|||||||0.261||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.261
71723111|NCT01942668|142962954|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=50% Reduction||||0.058
71723112|NCT01942668|142962954|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||\>=75% Reduction||||0.011
71723113|NCT01942668|142962955|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||<0.001
71723114|NCT01942668|142962955|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||<0.001
71657353|NCT02504671|142831741|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-12.7|1.9|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||1.9|-12.7|
71829956|NCT02527148|143164335|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Control cases||||<0.0001
71657354|NCT02504671|142831741|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71657355|NCT02504671|142831741|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657356|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657357|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657358|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657359|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657360|NCT02504671|142831741|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
71657361|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657362|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657363|NCT02504671|142831741|OTHER||Difference|27.0|||||TWO_SIDED|95.0|12.7|41.3|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.3|12.7|
71657364|NCT02504671|142831741|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657365|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71723115|NCT01942668|142962955|SUPERIORITY|||||||0.115||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.115
71723116|NCT01942668|142962955|SUPERIORITY|||||||0.11||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.110
71723117|NCT01942668|142962955|SUPERIORITY|||||||0.089||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.089
71723118|NCT01942668|142962955|SUPERIORITY|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.074
71723119|NCT01942668|142962955|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=50% Reduction||||0.011
71723120|NCT01942668|142962955|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||\>=75% Reduction||||0.008
71723121|NCT01942668|142962956|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71723122|NCT01942668|142962956|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71723123|NCT01942668|142962956|SUPERIORITY|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.011
71723124|NCT01942668|142962956|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71723125|NCT01942668|142962956|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||0.002
71723126|NCT01942668|142962956|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||0.002
71723127|NCT01942668|142962956|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=50% Reduction||||<0.001
71769488|NCT02446743|143039192|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
71769489|NCT02446743|143039192|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1(V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
71723128|NCT01942668|142962956|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||\>=75% Reduction||||<0.001
71723129|NCT01942668|142962957|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||<0.001
71723130|NCT01942668|142962957|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||<0.001
71723131|NCT01942668|142962957|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.048
71723132|NCT01942668|142962957|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.006
71723133|NCT01942668|142962957|SUPERIORITY|||||||0.063||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.063
71723134|NCT01942668|142962957|SUPERIORITY|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.058
71723135|NCT01942668|142962957|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=50% Reduction||||0.004
71723136|NCT01942668|142962957|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||\>=75% Reduction||||0.003
71723137|NCT01942668|142962958|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||<0.001
71723138|NCT01942668|142962958|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||<0.001
71723139|NCT01942668|142962958|SUPERIORITY|||||||0.05||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.050
71723140|NCT01942668|142962958|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.006
71723141|NCT01942668|142962958|SUPERIORITY|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.048
71723142|NCT01942668|142962958|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.004
71723143|NCT01942668|142962958|SUPERIORITY|||||||0.02||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=50% Reduction||||0.020
71723144|NCT01942668|142962958|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||\>=75% Reduction||||0.001
71723145|NCT01942668|142962959|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
71723146|NCT01942668|142962959|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71723147|NCT01942668|142962959|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.001
71723148|NCT01942668|142962959|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71723149|NCT01942668|142962959|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||0.006
71723150|NCT01942668|142962959|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71723151|NCT01942668|142962959|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=50% Reduction||||<0.001
71723152|NCT01942668|142962959|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||\>=75% Reduction||||<0.001
71723153|NCT01942668|142962960|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||<0.001
71723154|NCT01942668|142962960|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
71723155|NCT01942668|142962960|SUPERIORITY|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.013
71723156|NCT01942668|142962960|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||<0.001
71723157|NCT01942668|142962960|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.001
71829957|NCT02527148|143164335|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Improvement from preoperative to 12 months for the Shapematch cases||||<0.0001
71829958|NCT02527148|143164335|SUPERIORITY|||||||0.4387|||||||t-test, 2 sided|p-values from repeated ANOVA with change from preoperative variable/scores as dependent variable.||To compare improvement of OKS from preoperative to 12 months between both groups.||||0.4387
71723158|NCT01942668|142962960|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.004
71723159|NCT01942668|142962960|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=50% Reduction||||0.003
71723160|NCT01942668|142962960|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||\>=75% Reduction||||0.001
71723161|NCT01942668|142962961|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71723162|NCT01942668|142962961|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71723163|NCT01942668|142962961|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||<0.001
71723164|NCT01942668|142962961|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71723165|NCT01942668|142962961|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.001
71769490|NCT02446743|143039192|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
71769491|NCT02446743|143039192|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
71769492|NCT02446743|143039192|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|Vaccine group difference|-20.0|||||TWO_SIDED|95.0|-35.2|-7.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-7.5|-35.2|
71769493|NCT02446743|143039192|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-32.0|||||TWO_SIDED|95.0|-46.5|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.7|-46.5|
71887836|NCT01360645|143296835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0422|TWO_SIDED|95.0|-0.4|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11||-0.01|-0.40|0.0422
71723166|NCT01942668|142962961|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71723167|NCT01942668|142962961|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=50% Reduction||||0.004
71723168|NCT01942668|142962961|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||\>=75% Reduction||||<0.001
71723169|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
71723170|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71723171|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
71769494|NCT02446743|143039192|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|Vaccine group difference|-28.0|||||TWO_SIDED|95.0|-38.4|-17.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-17.1|-38.4|
71723172|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71723173|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||<0.001
71723174|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71723175|NCT01942668|142962962|SUPERIORITY|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=50% Reduction||||0.001
71723176|NCT01942668|142962962|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||\>=75% Reduction||||<0.001
71723177|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723178|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723179|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723180|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723181|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723182|NCT01942668|142962963|SUPERIORITY|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||0.003
71723183|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=50% Reduction||||<0.001
71723184|NCT01942668|142962963|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||\>=75% Reduction||||<0.001
71723185|NCT01942668|142962964|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71723186|NCT01942668|142962964|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71723187|NCT01942668|142962964|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71723188|NCT01942668|142962964|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||<0.001
71723189|NCT01942668|142962964|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71723190|NCT01942668|142962964|SUPERIORITY|||||||0.056||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.056
71657366|NCT02504671|142831741|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71723191|NCT01942668|142962964|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=50% Reduction||||<0.001
71723192|NCT01942668|142962964|SUPERIORITY|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||\>=75% Reduction||||0.017
71723193|NCT01942668|142962965|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||<0.001
71723194|NCT01942668|142962965|SUPERIORITY|||||||0.005||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||||||0.005
71723195|NCT01942668|142962965|SUPERIORITY|||||||0.007||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.007
71723196|NCT01942668|142962965|SUPERIORITY|||||||0.004||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||||||0.004
71723197|NCT01942668|142962967|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
71723198|NCT01942668|142962967|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||||||<0.001
71723199|NCT01942668|142962967|SUPERIORITY|||||||0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.001
71723200|NCT01942668|142962967|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||||||0.002
71723201|NCT01942668|142962969|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
71723202|NCT01942668|142962969|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
71723203|NCT01942668|142962969|SUPERIORITY||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||<0.001
71723204|NCT01942668|142962969|SUPERIORITY|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||||||0.002
71723205|NCT01942668|142962971|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71723206|NCT01942668|142962971|SUPERIORITY|||||||0.122|||||||Fisher Exact|||||||0.122
71723207|NCT01942668|142962971|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.280
71723208|NCT01942668|142962971|SUPERIORITY|||||||0.692|||||||Fisher Exact|||||||0.692
71723209|NCT01942668|142962972|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71723210|NCT01942668|142962972|SUPERIORITY|||||||0.069|||||||Fisher Exact|||||||0.069
71723211|NCT01942668|142962972|SUPERIORITY|||||||0.131|||||||Fisher Exact|||||||0.131
71723212|NCT01942668|142962972|SUPERIORITY|||||||0.661|||||||Fisher Exact|||||||0.661
71723213|NCT01942668|142962973|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71723214|NCT01942668|142962973|SUPERIORITY|||||||0.04|||||||Fisher Exact|||||||0.040
71723215|NCT01942668|142962973|SUPERIORITY|||||||0.082|||||||Fisher Exact|||||||0.082
71723216|NCT01942668|142962973|SUPERIORITY|||||||0.495|||||||Fisher Exact|||||||0.495
71723217|NCT01942668|142962974|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71723218|NCT01942668|142962974|SUPERIORITY|||||||0.032|||||||Fisher Exact|||||||0.032
71723219|NCT01942668|142962974|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
71723220|NCT01942668|142962974|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
71723221|NCT01942668|142962975|SUPERIORITY|||||||0|||||||Fisher Exact|||||||0.000
71723222|NCT01942668|142962975|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
71723223|NCT01942668|142962975|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.260
71723224|NCT01942668|142962975|SUPERIORITY|||||||0.792|||||||Fisher Exact|||||||0.792
71723225|NCT01942668|142962976|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71723226|NCT01942668|142962976|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
71723227|NCT01942668|142962976|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
71723228|NCT01942668|142962976|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723229|NCT01942668|142962977|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71723230|NCT01942668|142962977|SUPERIORITY|||||||0.075|||||||Fisher Exact|||||||0.075
71723231|NCT01942668|142962977|SUPERIORITY|||||||0.225|||||||Fisher Exact|||||||0.225
71723232|NCT01942668|142962977|SUPERIORITY|||||||0.769|||||||Fisher Exact|||||||0.769
71723233|NCT01942668|142962978|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71723234|NCT01942668|142962978|SUPERIORITY|||||||0.084|||||||Fisher Exact|||||||0.084
71723235|NCT01942668|142962978|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
71723236|NCT01942668|142962978|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
71723237|NCT01942668|142962979|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71723238|NCT01942668|142962979|SUPERIORITY|||||||0.125|||||||Fisher Exact|||||||0.125
71829959|NCT02527148|143164335|SUPERIORITY|||||||0.261|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 2 years between both groups.||||0.2610
71723239|NCT01942668|142962979|SUPERIORITY|||||||0.386|||||||Fisher Exact|||||||0.386
71723240|NCT01942668|142962979|SUPERIORITY|||||||0.737|||||||Fisher Exact|||||||0.737
71723241|NCT01942668|142962980|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71723242|NCT01942668|142962980|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
71723243|NCT01942668|142962980|SUPERIORITY|||||||0.745|||||||Fisher Exact|||||||0.745
71723244|NCT01942668|142962980|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723245|NCT01942668|142962981|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
71723246|NCT01942668|142962981|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
71723247|NCT01942668|142962981|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723248|NCT01942668|142962981|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723249|NCT01942668|142962982|SUPERIORITY|||||||0.261|||||||Fisher Exact|||||||0.261
71723250|NCT01942668|142962982|SUPERIORITY|||||||0.536|||||||Fisher Exact|||||||0.536
71723251|NCT01942668|142962982|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723252|NCT01942668|142962982|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723253|NCT01942668|142962983|SUPERIORITY|||||||0.463|||||||Fisher Exact|||||||0.463
71723254|NCT01942668|142962983|SUPERIORITY|||||||0.687|||||||Fisher Exact|||||||0.687
71723255|NCT01942668|142962983|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723256|NCT01942668|142962983|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723257|NCT01942668|142962984|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723258|NCT01942668|142962984|SUPERIORITY|||||||0.048|||||||Fisher Exact|||||||0.048
71723259|NCT01942668|142962984|SUPERIORITY|||||||0.049|||||||Fisher Exact|||||||0.049
71723260|NCT01942668|142962984|SUPERIORITY|||||||0.328|||||||Fisher Exact|||||||0.328
71723261|NCT01942668|142962985|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723262|NCT01942668|142962985|SUPERIORITY|||||||0.123|||||||Fisher Exact|||||||0.123
71723263|NCT01942668|142962985|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.030
71723264|NCT01942668|142962985|SUPERIORITY|||||||0.649|||||||Fisher Exact|||||||0.649
71723265|NCT01942668|142962986|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723266|NCT01942668|142962986|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
71723267|NCT01942668|142962986|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
71723268|NCT01942668|142962986|SUPERIORITY|||||||0.426|||||||Fisher Exact|||||||0.426
71723269|NCT01942668|142962987|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723270|NCT01942668|142962987|SUPERIORITY|||||||0.044|||||||Fisher Exact|||||||0.044
71723271|NCT01942668|142962987|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71723272|NCT01942668|142962987|SUPERIORITY|||||||0.481|||||||Fisher Exact|||||||0.481
71723273|NCT01942668|142962988|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723274|NCT01942668|142962988|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.110
71723275|NCT01942668|142962988|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
71723276|NCT01942668|142962988|SUPERIORITY|||||||0.853|||||||Fisher Exact|||||||0.853
71723277|NCT01942668|142962989|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723278|NCT01942668|142962989|SUPERIORITY|||||||0.245|||||||Fisher Exact|||||||0.245
71723279|NCT01942668|142962989|SUPERIORITY|||||||0.145|||||||Fisher Exact|||||||0.145
71723280|NCT01942668|142962989|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723281|NCT01942668|142962990|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723282|NCT01942668|142962990|SUPERIORITY|||||||0.163|||||||Fisher Exact|||||||0.163
71723283|NCT01942668|142962990|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
71723284|NCT01942668|142962990|SUPERIORITY|||||||0.693|||||||Fisher Exact|||||||0.693
71723285|NCT01942668|142962991|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723286|NCT01942668|142962991|SUPERIORITY|||||||0.178|||||||Fisher Exact|||||||0.178
71723287|NCT01942668|142962991|SUPERIORITY|||||||0.097|||||||Fisher Exact|||||||0.097
71829960|NCT02527148|143164335|SUPERIORITY|||||||0.8458|||||||t-test, 2 sided|||To compare improvement of OKS from preoperative to 5 years between both groups.||||0.8458
71829961|NCT02527148|143164336|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||To compare mean duration of surgery between both groups.||||0.10
71829962|NCT02527148|143164337|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||To compare wound length between both groups.||||0.05
71723288|NCT01942668|142962991|SUPERIORITY|||||||0.522|||||||Fisher Exact|||||||0.522
71723289|NCT01942668|142962992|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71829963|NCT02527148|143164339|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||To compare average length of hospital stay between both groups.||||0.07
71829964|NCT02527148|143164340|SUPERIORITY||Mean Difference (Final Values)|-0.023||||0.55|TWO_SIDED||||||t-test, 2 sided|||Comparison of baseline differences||||0.55
71829965|NCT02527148|143164340|SUPERIORITY||Mean Difference (Final Values)|-0.043||||0.23|TWO_SIDED||||||t-test, 2 sided|||Analysis of QALY between each instrument platform at 12-months||||0.23
71829966|NCT02527148|143164341|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.724|||||||t-test, 2 sided|||To compare VAS rest preoperatively between both groups.||||0.7240
71829967|NCT02527148|143164341|EQUIVALENCE|To determine equivalence in baseline characteristics between the control and intervention group.||||||0.7545|||||||t-test, 2 sided|||To compare VAS mobilisation preoperatively between both groups.||||0.7545
71723290|NCT01942668|142962992|SUPERIORITY|||||||0.315|||||||Fisher Exact|||||||0.315
71723291|NCT01942668|142962992|SUPERIORITY|||||||0.181|||||||Fisher Exact|||||||0.181
71829968|NCT02527148|143164341|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6921|||||||t-test, 2 sided|||To compare VAS rest at 6 weeks between both groups.||||0.6921
71829969|NCT02527148|143164341|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.9601|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 weeks between both groups.||||0.9601
71829970|NCT02527148|143164341|NON_INFERIORITY|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0697|||||||t-test, 2 sided|||To compare VAS rest at 6 months between both groups.||||0.0697
71829971|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.0342|||||||t-test, 2 sided|||To compare VAS mobilisation at 6 months between both groups.||||0.0342
71829972|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.3487|||||||t-test, 2 sided|||To compare VAS rest at 12 months between both groups.||||0.3487
71829973|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2201|||||||t-test, 2 sided|||To compare VAS mobilisation at 1 year between both groups.||||0.2201
71723292|NCT01942668|142962992|SUPERIORITY|||||||0.821|||||||Fisher Exact|||||||0.821
71723293|NCT01942668|142962993|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71723294|NCT01942668|142962993|SUPERIORITY|||||||0.387|||||||Fisher Exact|||||||0.387
71723295|NCT01942668|142962993|SUPERIORITY|||||||0.215|||||||Fisher Exact|||||||0.215
71829974|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.2291|||||||t-test, 2 sided|||To compare VAS rest at 2 years between both groups.||||0.2291
71657367|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71723296|NCT01942668|142962993|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
71723297|NCT01942668|142962994|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
71723298|NCT01942668|142962994|SUPERIORITY|||||||0.643|||||||Fisher Exact|||||||0.643
71723299|NCT01942668|142962994|SUPERIORITY|||||||0.501|||||||Fisher Exact|||||||0.501
71723300|NCT01942668|142962994|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723301|NCT01942668|142962995|SUPERIORITY|||||||0.013|||||||Fisher Exact|||||||0.013
71723302|NCT01942668|142962995|SUPERIORITY|||||||0.616|||||||Fisher Exact|||||||0.616
71723303|NCT01942668|142962995|SUPERIORITY|||||||0.352|||||||Fisher Exact|||||||0.352
71723304|NCT01942668|142962995|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71723305|NCT01942668|142962996|SUPERIORITY|||||||0.023|||||||Fisher Exact|||||||0.023
71723306|NCT01942668|142962996|SUPERIORITY|||||||0.535|||||||Fisher Exact|||||||0.535
71723307|NCT01942668|142962996|SUPERIORITY|||||||0.183|||||||Fisher Exact|||||||0.183
71723308|NCT01942668|142962996|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
71723309|NCT01942668|142962997|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||<0.001
71723310|NCT01942668|142962997|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.004
71723311|NCT01942668|142962997|SUPERIORITY|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.012
71723312|NCT01942668|142962997|SUPERIORITY|||||||0.032||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.032
71723313|NCT01942668|142962998|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
71723314|NCT01942668|142962998|SUPERIORITY|||||||0.022||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.022
71829975|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.6436|||||||t-test, 2 sided|||To compare VAS mobilisation at 2 years between both groups.||||0.6436
71829976|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.4344|||||||t-test, 2 sided|||To compare VAS rest at 5 years between both groups.||||0.4344
71723315|NCT01942668|142962998|SUPERIORITY|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.004
71887837|NCT01360645|143296835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0003|TWO_SIDED|95.0|-0.61|-0.18|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12||-0.18|-0.61|0.0003
71723316|NCT01942668|142962998|SUPERIORITY|||||||0.256||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.256
71723317|NCT01942668|142962999|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||<0.001
71723318|NCT01942668|142962999|SUPERIORITY|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.006
71723319|NCT01942668|142962999|SUPERIORITY|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.025
71769495|NCT02446743|143039192|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|9.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.2|-19.2|
71769496|NCT02446743|143039192|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-14.1|12.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||12.3|-14.1|
71723320|NCT01942668|142962999|SUPERIORITY|||||||0.182||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.182
71723321|NCT01942668|142963000|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.002
71723322|NCT01942668|142963000|SUPERIORITY|||||||0.469||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.469
71723323|NCT01942668|142963000|SUPERIORITY|||||||0.188||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.188
71723324|NCT01942668|142963000|SUPERIORITY|||||||0.613||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||0.613
71769497|NCT02446743|143039192|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-13.6|5.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||5.6|-13.6|
71887838|NCT01360645|143296835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0002|TWO_SIDED|95.0|-0.64|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13||-0.20|-0.64|0.0002
71723325|NCT01942668|142963005|SUPERIORITY|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.002
71723326|NCT01942668|142963005|SUPERIORITY|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact|||||||0.135
71723327|NCT01942668|142963005|SUPERIORITY|||||||0.26||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.260
71723328|NCT01942668|142963005|SUPERIORITY|||||||0.257||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact|||||||0.257
71723329|NCT01942668|142963006|SUPERIORITY||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||<0.001
71723330|NCT01942668|142963006|SUPERIORITY|||||||0.085||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact|||||||0.085
71723331|NCT01942668|142963006|SUPERIORITY|||||||0.184||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.184
71723332|NCT01942668|142963006|SUPERIORITY|||||||0.681||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact|||||||0.681
71723333|NCT01942668|142963007|SUPERIORITY|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.008
71723334|NCT01942668|142963007|SUPERIORITY|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact|||||||0.036
71723335|NCT01942668|142963007|SUPERIORITY|||||||0.138||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.138
71723336|NCT01942668|142963007|SUPERIORITY|||||||0.685||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact|||||||0.685
71723337|NCT01942668|142963008|SUPERIORITY|||||||0.023||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.023
71723338|NCT01942668|142963008|SUPERIORITY|||||||0.265||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact|||||||0.265
71723339|NCT01942668|142963008|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
71723340|NCT01942668|142963008|SUPERIORITY|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact|||||||1.000
71829977|NCT02527148|143164341|EQUIVALENCE|Precision Knee Navigation is the current standard of care and is the control against the newer intervention of OtisMed® ShapeMatch® with Triathlon||||||0.8732|||||||t-test, 2 sided|||To compare VAS mobilisation at 5 years between both groups.||||0.8732
71723341|NCT01942668|142963013|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.246|<|0.001|TWO_SIDED|95.0|-2.13|-1.17||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.17|-2.13|<0.001
71723342|NCT01942668|142963013|SUPERIORITY||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.79|-0.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.84|-1.79|<0.001
71723343|NCT01942668|142963013|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.242|<|0.001|TWO_SIDED|95.0|-1.64|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.69|-1.64|<0.001
71723344|NCT01942668|142963013|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.51|-0.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.58|-1.51|<0.001
71723345|NCT01942668|142963014|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.258|<|0.001|TWO_SIDED|95.0|-1.91|-0.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.89|-1.91|<0.001
71723346|NCT01942668|142963014|SUPERIORITY||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.253|<|0.001|TWO_SIDED|95.0|-1.81|-0.82||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.82|-1.81|<0.001
71723347|NCT01942668|142963014|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.257|<|0.001|TWO_SIDED|95.0|-1.63|-0.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.62|-1.63|<0.001
71723348|NCT01942668|142963014|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.254||0.007|TWO_SIDED|95.0|-1.19|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.19|-1.19|0.007
71723349|NCT01942668|142963015|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-1.75|-0.66||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.66|-1.75|<0.001
71723350|NCT01942668|142963015|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.265|<|0.001|TWO_SIDED|95.0|-1.98|-0.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.94|-1.98|<0.001
71723351|NCT01942668|142963015|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.272|<|0.001|TWO_SIDED|95.0|-1.76|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.69|-1.76|<0.001
71723352|NCT01942668|142963015|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.272||0.008|TWO_SIDED|95.0|-1.26|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.19|-1.26|0.008
71723353|NCT01942668|142963016|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.161||0.284|TWO_SIDED|95.0|-0.49|0.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.49|0.284
71723354|NCT01942668|142963016|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.732|TWO_SIDED|95.0|-0.36|0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.26|-0.36|0.732
71723355|NCT01942668|142963016|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.159||0.437|TWO_SIDED|95.0|-0.44|0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.44|0.437
71723356|NCT01942668|142963016|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.156||0.439|TWO_SIDED|95.0|-0.43|0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.19|-0.43|0.439
71723357|NCT01942668|142963017|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.04|TWO_SIDED|95.0|-0.68|-0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.02|-0.68|0.040
71829978|NCT02527148|143164342|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||To compare WOMAC preoperatively between both groups.||||0.911
71829979|NCT02527148|143164342|SUPERIORITY|||||||0.588|||||||t-test, 2 sided|||To compare WOMAC at 6-weeks between both groups.||||0.588
71829980|NCT02527148|143164342|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||To compare WOMAC at 6-months between both groups.||||0.030
71829981|NCT02527148|143164342|SUPERIORITY|||||||0.131|||||||t-test, 2 sided|||To compare WOMAC at 1-year between both groups.||||0.131
71723358|NCT01942668|142963017|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.165||0.066|TWO_SIDED|95.0|-0.63|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.02|-0.63|0.066
71829982|NCT02527148|143164342|SUPERIORITY|||||||0.347|||||||t-test, 2 sided|||To compare WOMAC at 2-years between both groups.||||0.347
71769498|NCT02446743|143039192|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Vaccine group difference|12.0|||||TWO_SIDED|95.0|3.6|21.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||21.6|3.6|
71769499|NCT02446743|143039192|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|15.0|||||TWO_SIDED|95.0|6.4|24.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||24.6|6.4|
71769500|NCT02446743|143039192|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|Vaccine group difference|14.0|||||TWO_SIDED|95.0|7.6|20.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||20.3|7.6|
71769501|NCT02446743|143039193|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-44.0|||||TWO_SIDED|95.0|-52.7|-33.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-33.1|-52.7|
71769502|NCT02446743|143039193|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.6|-3.9|
71769503|NCT02446743|143039193|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-2.7|2.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.4|-2.7|
71769504|NCT02446743|143039193|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-46.0|||||TWO_SIDED|95.0|-58.4|-29.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-29.8|-58.4|
71769505|NCT02446743|143039193|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-7.7|5.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.1|-7.7|
71769506|NCT02446743|143039193|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
71769507|NCT02446743|143039193|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-40.0|||||TWO_SIDED|95.0|-51.8|-25.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.4|-51.8|
71769508|NCT02446743|143039193|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.3|9.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.0|-3.3|
71769509|NCT02446743|143039193|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.4|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-2.4|
71657368|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71769510|NCT02446743|143039193|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-12.4|5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.8|-12.4|
71769511|NCT02446743|143039193|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.2|7.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.7|-2.2|
71657369|NCT02504671|142831741|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71723359|NCT01942668|142963017|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.469|TWO_SIDED|95.0|-0.45|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|-0.45|0.469
71723360|NCT01942668|142963017|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.166||0.616|TWO_SIDED|95.0|-0.41|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.41|0.616
71723361|NCT01942668|142963018|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.183||0.25|TWO_SIDED|95.0|-0.57|0.15||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.57|0.250
71723362|NCT01942668|142963018|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.175||0.002|TWO_SIDED|95.0|-0.88|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.20|-0.88|0.002
71723363|NCT01942668|142963018|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.179||0.796|TWO_SIDED|95.0|-0.4|0.31||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.31|-0.40|0.796
71723364|NCT01942668|142963018|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.179||0.955|TWO_SIDED|95.0|-0.36|0.34||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.34|-0.36|0.955
71723365|NCT01942668|142963019|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.143||0.474|TWO_SIDED|95.0|-0.38|0.18||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.18|-0.38|0.474
71723366|NCT01942668|142963019|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.378|TWO_SIDED|95.0|-0.4|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.15|-0.40|0.378
71723367|NCT01942668|142963019|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.141||0.018|TWO_SIDED|95.0|-0.61|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.61|0.018
71723368|NCT01942668|142963019|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.73|TWO_SIDED|95.0|-0.32|0.22||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.22|-0.32|0.730
71723369|NCT01942668|142963020|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.152||0.197|TWO_SIDED|95.0|-0.49|0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.10|-0.49|0.197
71723370|NCT01942668|142963020|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.148||0.308|TWO_SIDED|95.0|-0.44|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.44|0.308
71723371|NCT01942668|142963020|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.152||0.117|TWO_SIDED|95.0|-0.54|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.06|-0.54|0.117
71723372|NCT01942668|142963020|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.149||0.739|TWO_SIDED|95.0|-0.34|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.34|0.739
71723373|NCT01942668|142963021|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.635|TWO_SIDED|95.0|-0.42|0.26||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.26|-0.42|0.635
71723374|NCT01942668|142963021|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.164||0.01|TWO_SIDED|95.0|-0.75|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.75|0.010
71723375|NCT01942668|142963021|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.169||0.092|TWO_SIDED|95.0|-0.62|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.62|0.092
71723376|NCT01942668|142963021|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.168||0.243|TWO_SIDED|95.0|-0.53|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.13|-0.53|0.243
71723377|NCT01942668|142963022|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.21||0.049|TWO_SIDED|95.0|-0.83|0.0||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.00|-0.83|0.049
71723378|NCT01942668|142963022|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.206||0.773|TWO_SIDED|95.0|-0.34|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.46|-0.34|0.773
71723379|NCT01942668|142963022|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.208||0.081|TWO_SIDED|95.0|-0.77|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.05|-0.77|0.081
71723380|NCT01942668|142963022|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.204||0.625|TWO_SIDED|95.0|-0.5|0.3||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.30|-0.50|0.625
71723381|NCT01942668|142963023|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.221||0.221|TWO_SIDED|95.0|-0.7|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.70|0.221
71657370|NCT02504671|142831741|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657371|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71723382|NCT01942668|142963023|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.214||0.992|TWO_SIDED|95.0|-0.42|0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.42|-0.42|0.992
71723383|NCT01942668|142963023|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.181|TWO_SIDED|95.0|-0.72|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.14|-0.72|0.181
71657372|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657373|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657374|NCT02504671|142831741|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657375|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657376|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657377|NCT02504671|142831741|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657378|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657379|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657380|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657381|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657382|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657383|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657384|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657385|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657386|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71723384|NCT01942668|142963023|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.216||0.846|TWO_SIDED|95.0|-0.47|0.38||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.38|-0.47|0.846
71723385|NCT01942668|142963024|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.257||0.421|TWO_SIDED|95.0|-0.71|0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.30|-0.71|0.421
71723386|NCT01942668|142963024|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.244||0.044|TWO_SIDED|95.0|-0.97|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.01|-0.97|0.044
71657387|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657388|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657389|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657390|NCT02504671|142831741|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657391|NCT02504671|142831741|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657392|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657393|NCT02504671|142831741|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657394|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71723387|NCT01942668|142963024|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.252||0.093|TWO_SIDED|95.0|-0.92|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.92|0.093
71829983|NCT02527148|143164342|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||To compare WOMAC at 5-years between both groups.||||0.341
71657395|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657396|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657397|NCT02504671|142831741|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71657398|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71657399|NCT02504671|142831741|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657400|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71769512|NCT02446743|143039193|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|2.8|10.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.5|2.8|
71769513|NCT02446743|143039193|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-17.8|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-17.8|
71769514|NCT02446743|143039193|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|13.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.0|-3.2|
71769515|NCT02446743|143039193|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|9.0|||||TWO_SIDED|95.0|3.7|16.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.5|3.7|
71769516|NCT02446743|143039193|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-11.8|11.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||11.0|-11.8|
71769517|NCT02446743|143039193|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-4.6|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-4.6|
71769518|NCT02446743|143039193|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-0.8|9.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-0.8|
71829984|NCT02527148|143164343|SUPERIORITY|||||||0.452|||||||t-test, 2 sided|||To compare EQ-5D index preoperatively between both groups.||||0.452
71829985|NCT02527148|143164343|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.201
71829986|NCT02527148|143164343|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||To compare EQ-5D index at 6-weeks between both groups.||||0.741
71829987|NCT02527148|143164343|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-weeks between both groups.||||0.794
71829988|NCT02527148|143164343|SUPERIORITY|||||||0.232|||||||t-test, 2 sided|||To compare EQ-5D index at 6-months between both groups.||||0.232
71829989|NCT02527148|143164343|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||To compare EQ-5D VAS at 6-months between both groups.||||0.513
71829990|NCT02527148|143164343|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||To compare EQ-5D index at 1-year between both groups.||||0.180
71829991|NCT02527148|143164343|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||To compare EQ-5D VAS at 1-year between both groups.||||0.864
71829992|NCT02527148|143164343|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare EQ-5D index at 2-year between both groups.||||0.223
71829993|NCT02527148|143164343|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||To compare EQ-5D VAS at 2-year between both groups.||||0.355
71829994|NCT02527148|143164343|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||To compare EQ-5D index at 5-year between both groups.||||0.314
71829995|NCT02527148|143164343|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||To compare EQ-5D VAS at 5-year between both groups.||||0.914
71829996|NCT02527148|143164344|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||To compare FJS at 6-weeks between both groups.||||0.523
71829997|NCT02527148|143164344|SUPERIORITY|||||||0.932|||||||t-test, 2 sided|||To compare FJS at 6-months between both groups.||||0.932
71829998|NCT02527148|143164344|SUPERIORITY|||||||0.934|||||||t-test, 2 sided|||To compare FJS at 1-year between both groups.||||0.934
71829999|NCT02527148|143164344|SUPERIORITY|||||||0.566|||||||t-test, 2 sided|||To compare FJS at 2-year between both groups.||||0.566
71830000|NCT02527148|143164344|SUPERIORITY|||||||0.263|||||||t-test, 2 sided|||To compare FJS at 5-year between both groups.||||0.263
71830001|NCT02527148|143164345|SUPERIORITY|||||||0.3768|||||||t-test, 2 sided|||To compare IKSS Pain preoperatively between both groups.||||0.3768
71887839|NCT01360645|143296835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14||-0.19|-0.65|0.0003
71657401|NCT02504671|142831741|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657402|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657403|NCT02504671|142831741|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657404|NCT02504671|142831741|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71657405|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657406|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657407|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657408|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657409|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657410|NCT02504671|142831741|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657411|NCT02504671|142831741|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657412|NCT02504671|142831741|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657413|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657414|NCT02504671|142831741|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657415|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657416|NCT02504671|142831741|OTHER||Difference|24.3|||||TWO_SIDED|95.0|10.5|38.1|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.1|10.5|
71657417|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657418|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657419|NCT02504671|142831741|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657420|NCT02504671|142831741|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71657421|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657422|NCT02504671|142831741|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657423|NCT02504671|142831741|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657424|NCT02504671|142831741|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657425|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.32||||0.046|TWO_SIDED|95.0|-0.64|-0.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.01|-0.64|0.046
71657426|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.3||||0.071|TWO_SIDED|95.0|-0.62|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||0.03|-0.62|0.071
71657427|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.37||||0.022|TWO_SIDED|95.0|-0.69|-0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.05|-0.69|0.022
71657428|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.28||||0.16|TWO_SIDED|95.0|-0.67|0.11||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.11|-0.67|0.160
71657429|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.32||||0.103|TWO_SIDED|95.0|-0.71|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||0.07|-0.71|0.103
71657430|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.42||||0.034|TWO_SIDED|95.0|-0.8|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.03|-0.80|0.034
71657431|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.4||||0.096|TWO_SIDED|95.0|-0.87|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||0.07|-0.87|0.096
71887840|NCT01360645|143296836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0229|TWO_SIDED|95.0|-0.25|-0.02|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.02|-0.25|0.0229
71657432|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.56||||0.02|TWO_SIDED|95.0|-1.02|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.09|-1.02|0.020
71723388|NCT01942668|142963024|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.252||0.247|TWO_SIDED|95.0|-0.79|0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.79|0.247
71657433|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.76||||0.001|TWO_SIDED|95.0|-1.22|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.29|-1.22|0.001
71657434|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.42||||0.11|TWO_SIDED|95.0|-0.93|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.10|-0.93|0.110
71657435|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.47||||0.076|TWO_SIDED|95.0|-0.98|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.05|-0.98|0.076
71657436|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.61||||0.02|TWO_SIDED|95.0|-1.11|-0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.10|-1.11|0.020
71657437|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.42||||0.128|TWO_SIDED|95.0|-0.97|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||0.12|-0.97|0.128
71723389|NCT01942668|142963025|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.87|-0.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.29|-0.87|<0.001
71723390|NCT01942668|142963025|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.143||0.016|TWO_SIDED|95.0|-0.62|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.62|0.016
71723391|NCT01942668|142963025|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|TWO_SIDED|95.0|-0.76|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.76|<0.001
71723392|NCT01942668|142963025|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.141||0.023|TWO_SIDED|95.0|-0.6|-0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.05|-0.60|0.023
71723393|NCT01942668|142963026|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.25|-0.84|<0.001
71723394|NCT01942668|142963026|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.004|TWO_SIDED|95.0|-0.71|-0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.13|-0.71|0.004
71723395|NCT01942668|142963026|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.149||0.003|TWO_SIDED|95.0|-0.73|-0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.14|-0.73|0.003
71657438|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.78||||0.005|TWO_SIDED|95.0|-1.33|-0.24||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.24|-1.33|0.005
71657439|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.82||||0.003|TWO_SIDED|95.0|-1.36|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.29|-1.36|0.003
71657440|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.53||||0.11|TWO_SIDED|95.0|-1.17|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||0.12|-1.17|0.110
71657441|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.88||||0.008|TWO_SIDED|95.0|-1.53|-0.23||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.23|-1.53|0.008
71657442|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.24|||<|0.001|TWO_SIDED|95.0|-1.88|-0.6||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.60|-1.88|<0.001
71657443|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.29||||0.5|TWO_SIDED|95.0|-1.15|0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.56|-1.15|0.500
71723396|NCT01942668|142963026|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.147||0.179|TWO_SIDED|95.0|-0.49|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.09|-0.49|0.179
71723397|NCT01942668|142963027|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.169||0.012|TWO_SIDED|95.0|-0.76|-0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.76|0.012
71723398|NCT01942668|142963027|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|-1.05|-0.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.41|-1.05|<0.001
71723399|NCT01942668|142963027|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.004|TWO_SIDED|95.0|-0.81|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.16|-0.81|0.004
71723400|NCT01942668|142963027|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.166||0.07|TWO_SIDED|95.0|-0.63|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.03|-0.63|0.070
71723401|NCT01942668|142963028|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|2.059||0.033|TWO_SIDED|95.0|-8.44|-0.35||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.35|-8.44|0.033
71723402|NCT01942668|142963028|SUPERIORITY||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|2.015||0.207|TWO_SIDED|95.0|-6.5|1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.50|0.207
71723403|NCT01942668|142963028|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.03||0.024|TWO_SIDED|95.0|-8.58|-0.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.61|-8.58|0.024
71723404|NCT01942668|142963028|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|2.007||0.207|TWO_SIDED|95.0|-6.47|1.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.41|-6.47|0.207
71723405|NCT01942668|142963029|SUPERIORITY||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|2.138||0.011|TWO_SIDED|95.0|-9.68|-1.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.28|-9.68|0.011
71723406|NCT01942668|142963029|SUPERIORITY||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|2.093||0.012|TWO_SIDED|95.0|-9.36|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.14|-9.36|0.012
71723407|NCT01942668|142963029|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|2.122||0.009|TWO_SIDED|95.0|-9.75|-1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.41|-9.75|0.009
71723408|NCT01942668|142963029|SUPERIORITY||Mean Difference (Final Values)|-4.99|STANDARD_ERROR_OF_MEAN|2.096||0.018|TWO_SIDED|95.0|-9.11|-0.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.87|-9.11|0.018
71723409|NCT01942668|142963030|SUPERIORITY||Mean Difference (Final Values)|-4.61|STANDARD_ERROR_OF_MEAN|2.427||0.058|TWO_SIDED|95.0|-9.38|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.16|-9.38|0.058
71723410|NCT01942668|142963030|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|2.322||0.001|TWO_SIDED|95.0|-12.04|-2.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.92|-12.04|0.001
71723411|NCT01942668|142963030|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|2.397|<|0.001|TWO_SIDED|95.0|-12.67|-3.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.25|-12.67|<0.001
71723412|NCT01942668|142963030|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.404||0.005|TWO_SIDED|95.0|-11.5|-2.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.06|-11.50|0.005
71723413|NCT01942668|142963031|SUPERIORITY||Mean Difference (Final Values)|-6.48|STANDARD_ERROR_OF_MEAN|2.77||0.02|TWO_SIDED|95.0|-11.92|-1.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.04|-11.92|0.020
71657444|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.99||||0.021|TWO_SIDED|95.0|-1.83|-0.15||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.15|-1.83|0.021
71723414|NCT01942668|142963031|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.715||0.216|TWO_SIDED|95.0|-8.69|1.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.97|-8.69|0.216
71723415|NCT01942668|142963031|SUPERIORITY||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|2.734||0.033|TWO_SIDED|95.0|-11.22|-0.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.48|-11.22|0.033
71723416|NCT01942668|142963031|SUPERIORITY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|2.685||0.265|TWO_SIDED|95.0|-8.27|2.28||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.28|-8.27|0.265
71723417|NCT01942668|142963032|SUPERIORITY||Mean Difference (Final Values)|-7.54|STANDARD_ERROR_OF_MEAN|2.854||0.008|TWO_SIDED|95.0|-13.14|-1.93||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.93|-13.14|0.008
71723418|NCT01942668|142963032|SUPERIORITY||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.781||0.016|TWO_SIDED|95.0|-12.18|-1.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.26|-12.18|0.016
71723419|NCT01942668|142963032|SUPERIORITY||Mean Difference (Final Values)|-8.69|STANDARD_ERROR_OF_MEAN|2.847||0.002|TWO_SIDED|95.0|-14.28|-3.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.10|-14.28|0.002
71830002|NCT02527148|143164345|SUPERIORITY|||||||0.6425|||||||t-test, 2 sided|||To compare IKSS Function preoperatively between both groups.||||0.6425
71830003|NCT02527148|143164345|SUPERIORITY|||||||0.5041|||||||t-test, 2 sided|||To compare IKSS ROM preoperatively between both groups.||||0.5041
71830004|NCT02527148|143164345|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||To compare IKSS Pain at 6-weeks between both groups.||||0.2230
71830005|NCT02527148|143164345|SUPERIORITY|||||||0.8209|||||||t-test, 2 sided|||To compare IKSS Function at 6-weeks between both groups.||||0.8209
71723420|NCT01942668|142963032|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.8||0.028|TWO_SIDED|95.0|-11.68|-0.68||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.68|-11.68|0.028
71723421|NCT01942668|142963033|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|3.18||0.04|TWO_SIDED|95.0|-12.8|-0.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.31|-12.80|0.040
71723422|NCT01942668|142963033|SUPERIORITY||Mean Difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|3.04||0.001|TWO_SIDED|95.0|-15.99|-4.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.04|-15.99|0.001
71657445|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.0||||0.017|TWO_SIDED|95.0|-1.83|-0.18||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.18|-1.83|0.017
71723423|NCT01942668|142963033|SUPERIORITY||Mean Difference (Final Values)|-9.96|STANDARD_ERROR_OF_MEAN|3.129||0.002|TWO_SIDED|95.0|-16.11|-3.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.81|-16.11|0.002
71723424|NCT01942668|142963033|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|3.127||0.029|TWO_SIDED|95.0|-12.99|-0.7||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.70|-12.99|0.029
71723425|NCT01942668|142963034|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|3.003||0.294|TWO_SIDED|95.0|-2.75|9.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.05|-2.75|0.294
71723426|NCT01942668|142963034|SUPERIORITY||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.922||0.327|TWO_SIDED|95.0|-2.87|8.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||8.60|-2.87|0.327
71723427|NCT01942668|142963034|SUPERIORITY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.947||0.637|TWO_SIDED|95.0|-7.18|4.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.39|-7.18|0.637
71723428|NCT01942668|142963034|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|2.893||0.952|TWO_SIDED|95.0|-5.51|5.86||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||5.86|-5.51|0.952
71723429|NCT01942668|142963035|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|3.219||0.573|TWO_SIDED|95.0|-4.51|8.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||8.14|-4.51|0.573
71723430|NCT01942668|142963035|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|3.107||0.769|TWO_SIDED|95.0|-7.01|5.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.19|-7.01|0.769
71723431|NCT01942668|142963035|SUPERIORITY||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|3.176||0.047|TWO_SIDED|95.0|-12.56|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.09|-12.56|0.047
71723432|NCT01942668|142963035|SUPERIORITY||Mean Difference (Final Values)|-2.59|STANDARD_ERROR_OF_MEAN|3.133||0.409|TWO_SIDED|95.0|-8.74|3.56||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.56|-8.74|0.409
71723433|NCT01942668|142963036|SUPERIORITY||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.443||0.579|TWO_SIDED|95.0|-4.85|8.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.67|-4.85|0.579
71723434|NCT01942668|142963036|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|3.275||0.223|TWO_SIDED|95.0|-10.43|2.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.44|-10.43|0.223
71723435|NCT01942668|142963036|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|3.367||0.542|TWO_SIDED|95.0|-8.67|4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.56|-8.67|0.542
71723436|NCT01942668|142963036|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|3.376||0.476|TWO_SIDED|95.0|-9.04|4.23||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||4.23|-9.04|0.476
71723437|NCT01942668|142963037|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|2.593||0.631|TWO_SIDED|95.0|-6.34|3.84||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.84|-6.34|0.631
71723438|NCT01942668|142963037|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|2.54||0.651|TWO_SIDED|95.0|-3.84|6.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||6.14|-3.84|0.651
71723439|NCT01942668|142963037|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|2.578||0.813|TWO_SIDED|95.0|-5.67|4.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.45|-5.67|0.813
71723440|NCT01942668|142963037|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.515||0.869|TWO_SIDED|95.0|-5.35|4.52||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.52|-5.35|0.869
71723441|NCT01942668|142963038|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|2.79||0.074|TWO_SIDED|95.0|-10.48|0.48||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.48|-10.48|0.074
71723442|NCT01942668|142963038|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.722||0.748|TWO_SIDED|95.0|-6.22|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||4.47|-6.22|0.748
71830006|NCT02527148|143164345|SUPERIORITY|||||||0.6958|||||||t-test, 2 sided|||To compare IKSS ROM at 6-weeks between both groups.||||0.6958
71723443|NCT01942668|142963038|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.805||0.987|TWO_SIDED|95.0|-5.46|5.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||5.56|-5.46|0.987
71830007|NCT02527148|143164345|SUPERIORITY|||||||0.0548|||||||t-test, 2 sided|||To compare IKSS Pain at 6-months between both groups.||||0.0548
71830008|NCT02527148|143164345|SUPERIORITY|||||||0.1958|||||||t-test, 2 sided|||To compare IKSS Function at 6-months between both groups.||||0.1958
71830009|NCT02527148|143164345|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||To compare IKSS ROM at 6-months between both groups.||||0.2786
71830010|NCT02527148|143164345|SUPERIORITY|||||||0.2399|||||||t-test, 2 sided|||To compare IKSS Pain at 1-year between both groups.||||0.2399
71830011|NCT02527148|143164345|SUPERIORITY|||||||0.4135|||||||t-test, 2 sided|||To compare IKSS Function at 1-year between both groups.||||0.4135
71887841|NCT01360645|143296836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0459|TWO_SIDED|95.0|-0.28|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.00|-0.28|0.0459
71887842|NCT01360645|143296836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0097|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||-0.05|-0.37|0.0097
71887843|NCT01360645|143296836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0038|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.08|-0.42|0.0038
71723444|NCT01942668|142963038|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|2.741||0.709|TWO_SIDED|95.0|-6.41|4.36||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.36|-6.41|0.709
71723445|NCT01942668|142963039|SUPERIORITY||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|2.968||0.379|TWO_SIDED|95.0|-8.44|3.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.22|-8.44|0.379
71830012|NCT02527148|143164345|SUPERIORITY|||||||0.5278|||||||t-test, 2 sided|||To compare IKSS ROM at 1-year between both groups.||||0.5278
71830013|NCT02527148|143164345|SUPERIORITY|||||||0.2992|||||||t-test, 2 sided|||To compare IKSS Pain at 2-year between both groups.||||0.2992
71830014|NCT02527148|143164345|SUPERIORITY|||||||0.5462|||||||t-test, 2 sided|||To compare IKSS Function at 2-year between both groups.||||0.5462
71887844|NCT01360645|143296836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0001|TWO_SIDED|95.0|-0.54|-0.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.18|-0.54|0.0001
71723446|NCT01942668|142963039|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_ERROR_OF_MEAN|2.832||0.279|TWO_SIDED|95.0|-8.64|2.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.49|-8.64|0.279
71723447|NCT01942668|142963039|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.949||0.894|TWO_SIDED|95.0|-6.19|5.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.40|-6.19|0.894
71723448|NCT01942668|142963039|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.923||0.308|TWO_SIDED|95.0|-8.72|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.76|-8.72|0.308
71830015|NCT02527148|143164345|SUPERIORITY|||||||0.5765|||||||t-test, 2 sided|||To compare IKSS ROM at 2-year between both groups.||||0.5765
71830016|NCT02527148|143164345|SUPERIORITY|||||||0.5493|||||||t-test, 2 sided|||To compare IKSS Pain at 5-year between both groups.||||0.5493
71830017|NCT02527148|143164345|SUPERIORITY|||||||0.1705|||||||t-test, 2 sided|||To compare IKSS Function at 5-year between both groups.||||0.1705
71830018|NCT02527148|143164345|SUPERIORITY|||||||0.2918|||||||t-test, 2 sided|||To compare IKSS ROM at 5-year between both groups.||||0.2918
71830019|NCT02527148|143164346|OTHER|||||||0.6|||||||t-test, 2 sided|||Comparison of coronal mechanical axis:hip knee ankle angle between both groups.||||0.6
71830020|NCT02527148|143164346|OTHER|||||||0.002|||||||t-test, 2 sided|||Comparison of coronal angle fem comp and mech axis femur between both groups.||||0.002
71830021|NCT02527148|143164346|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of coronal angle tibial comp and mech axis tibia between both groups.||||<0.001
71830022|NCT02527148|143164346|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of sagital tibial component slope between both groups.||||<0.001
71830023|NCT02527148|143164346|OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of Fem comp rotation relative to surg epicond axis+=ER between both groups.||||<0.001
71830024|NCT00666276|143164349|SUPERIORITY_OR_OTHER||||||=|0.712|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs."||||=0.712
71830025|NCT00666276|143164350|SUPERIORITY_OR_OTHER||||||=|0.257|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs."||||=0.257
71830026|NCT00666276|143164351|SUPERIORITY_OR_OTHER||||||=|0.082|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs."||||=0.082
71887845|NCT01360645|143296836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0004|TWO_SIDED|95.0|-0.52|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14.||-0.15|-0.52|0.0004
71887846|NCT01360645|143296837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0109|TWO_SIDED|95.0|-0.27|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.04|-0.27|0.0109
71887847|NCT01360645|143296837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1286|TWO_SIDED|95.0|-0.25|0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.03|-0.25|0.1286
71887848|NCT01360645|143296837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0521|TWO_SIDED|95.0|-0.32|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.00|-0.32|0.0521
71887849|NCT01360645|143296837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0084|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||-0.06|-0.42|0.0084
71887850|NCT01360645|143296837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||-0.16|-0.54|0.0003
71657446|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.07||||0.871|TWO_SIDED|95.0|-0.98|0.83||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.83|-0.98|0.871
71723449|NCT01942668|142963040|SUPERIORITY||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|3.081||0.558|TWO_SIDED|95.0|-4.24|7.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.86|-4.24|0.558
71723450|NCT01942668|142963040|SUPERIORITY||Mean Difference (Final Values)|3.61|STANDARD_ERROR_OF_MEAN|3.031||0.233|TWO_SIDED|95.0|-2.34|9.57||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.57|-2.34|0.233
71723451|NCT01942668|142963040|SUPERIORITY||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|3.036||0.043|TWO_SIDED|95.0|0.2|12.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||12.13|0.20|0.043
71830027|NCT00666276|143164352|SUPERIORITY_OR_OTHER||||||=|0.462|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs."||||=0.462
71830028|NCT00666276|143164353|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs."||||<0.001
71830029|NCT00666276|143164354|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs."||||=0.018
71830030|NCT00666276|143164355|SUPERIORITY_OR_OTHER||||||=|0.311|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs."||||=0.311
71830031|NCT00666276|143164356|SUPERIORITY_OR_OTHER||||||=|0.044|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs."||||=0.044
71830032|NCT00666276|143164357|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs."||||=0.008
71830033|NCT00891930|143164370|SUPERIORITY|||||||0.013|||||||Regression, Cox|||||||0.0130
71830034|NCT01574807|143164393|SUPERIORITY||Percentage difference|0.0||||1|TWO_SIDED|||||Multiple McNemar tests corrected with Step-down Bonferroni method of Holm. A priori threshold for significance was 0.05.|McNemar|||||||1.00
71830035|NCT04303156|143164398|OTHER||GMR|2.2|||||TWO_SIDED|90.0|1.68|2.88|||||Severe Renal Impairment / Healthy|Geometric mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.88|1.68|
71830036|NCT04303156|143164399|OTHER||GMR|1.93|||||TWO_SIDED|90.0|1.46|2.55|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.55|1.46|
71830037|NCT04303156|143164400|OTHER||GMR|1.03|||||TWO_SIDED|90.0|0.67|1.57|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.57|0.67|
71830038|NCT04303156|143164403|OTHER||GMR|0.46|||||TWO_SIDED|90.0|0.35|0.6|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.60|0.35|
71830039|NCT04303156|143164404|OTHER||GMR|0.8|||||TWO_SIDED|90.0|0.56|1.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.56|
71830040|NCT04303156|143164405|OTHER||GMR|1.48|||||TWO_SIDED|90.0|1.03|2.14|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|2.14|1.03|
71830041|NCT04303156|143164406|OTHER||GMR|1.38|||||TWO_SIDED|90.0|0.98|1.93|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.93|0.98|
71830042|NCT04303156|143164407|OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.64|1.39|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.39|0.64|
71887851|NCT01360645|143296837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0006|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.15|-0.53|0.0006
71887852|NCT01360645|143296838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0139|TWO_SIDED|95.0|-2.82|-0.32|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.32|-2.82|0.0139
71723452|NCT01942668|142963040|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|2.99||0.488|TWO_SIDED|95.0|-3.8|7.95||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||7.95|-3.80|0.488
71723453|NCT01942668|142963041|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|3.206||0.205|TWO_SIDED|95.0|-2.23|10.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.37|-2.23|0.205
71723454|NCT01942668|142963041|SUPERIORITY||Mean Difference (Final Values)|9.58|STANDARD_ERROR_OF_MEAN|3.133||0.002|TWO_SIDED|95.0|3.43|15.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||15.74|3.43|0.002
71723455|NCT01942668|142963041|SUPERIORITY||Mean Difference (Final Values)|5.04|STANDARD_ERROR_OF_MEAN|3.193||0.115|TWO_SIDED|95.0|-1.23|11.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.32|-1.23|0.115
71723456|NCT01942668|142963041|SUPERIORITY||Mean Difference (Final Values)|8.94|STANDARD_ERROR_OF_MEAN|3.152||0.005|TWO_SIDED|95.0|2.75|15.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||15.13|2.75|0.005
71723457|NCT01942668|142963042|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|3.719||0.796|TWO_SIDED|95.0|-6.34|8.27||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||8.27|-6.34|0.796
71723458|NCT01942668|142963042|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|3.568||0.15|TWO_SIDED|95.0|-1.87|12.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||12.15|-1.87|0.150
71830043|NCT04303156|143164409|OTHER||GMR|0.97|||||TWO_SIDED|90.0|0.69|1.35|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.35|0.69|
71723459|NCT01942668|142963042|SUPERIORITY||Mean Difference (Final Values)|8.58|STANDARD_ERROR_OF_MEAN|3.657||0.019|TWO_SIDED|95.0|1.39|15.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||15.77|1.39|0.019
71723460|NCT01942668|142963042|SUPERIORITY||Mean Difference (Final Values)|7.51|STANDARD_ERROR_OF_MEAN|3.667||0.041|TWO_SIDED|95.0|0.3|14.71||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||14.71|0.30|0.041
71723461|NCT01942668|142963043|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.197||0.221|TWO_SIDED|95.0|-7.0|1.62||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.62|-7.00|0.221
71723462|NCT01942668|142963043|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|2.154||0.511|TWO_SIDED|95.0|-5.65|2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.81|-5.65|0.511
71723463|NCT01942668|142963043|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|2.168||0.761|TWO_SIDED|95.0|-3.6|4.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.92|-3.60|0.761
71723464|NCT01942668|142963043|SUPERIORITY||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.128||0.332|TWO_SIDED|95.0|-6.25|2.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.11|-6.25|0.332
71723465|NCT01942668|142963044|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.474||0.687|TWO_SIDED|95.0|-5.86|3.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.86|-5.86|0.687
71723466|NCT01942668|142963044|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|2.411||0.373|TWO_SIDED|95.0|-6.88|2.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.58|-6.88|0.373
71723467|NCT01942668|142963044|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|2.466||0.714|TWO_SIDED|95.0|-5.75|3.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.94|-5.75|0.714
71723468|NCT01942668|142963044|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.427||0.711|TWO_SIDED|95.0|-5.67|3.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.87|-5.67|0.711
71723469|NCT01942668|142963045|SUPERIORITY||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.682||0.415|TWO_SIDED|95.0|-7.46|3.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||3.08|-7.46|0.415
71723470|NCT01942668|142963045|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|2.564||0.019|TWO_SIDED|95.0|-11.04|-0.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.97|-11.04|0.019
71723471|NCT01942668|142963045|SUPERIORITY||Mean Difference (Final Values)|-4.72|STANDARD_ERROR_OF_MEAN|2.639||0.074|TWO_SIDED|95.0|-9.9|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.46|-9.90|0.074
71723472|NCT01942668|142963045|SUPERIORITY||Mean Difference (Final Values)|-5.75|STANDARD_ERROR_OF_MEAN|2.637||0.03|TWO_SIDED|95.0|-10.94|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.57|-10.94|0.030
71830044|NCT04303156|143164410|OTHER||GMR|1.82|||||TWO_SIDED|90.0|0.55|6.02|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|6.02|0.55|
71830045|NCT04303156|143164411|OTHER||GMR|2.69|||||TWO_SIDED|90.0|1.51|4.8|||||Severe Renal Impairment / Healthy|GMR|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|4.80|1.51|
71723473|NCT01942668|142963046|SUPERIORITY||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.109||0.059|TWO_SIDED|95.0|-8.13|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-8.13|0.059
71723474|NCT01942668|142963046|SUPERIORITY||Mean Difference (Final Values)|-2.57|STANDARD_ERROR_OF_MEAN|2.067||0.215|TWO_SIDED|95.0|-6.63|1.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.49|-6.63|0.215
71723475|NCT01942668|142963046|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|2.084||0.015|TWO_SIDED|95.0|-9.19|-1.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.00|-9.19|0.015
71723476|NCT01942668|142963046|SUPERIORITY||Mean Difference (Final Values)|-3.16|STANDARD_ERROR_OF_MEAN|2.042||0.122|TWO_SIDED|95.0|-7.17|0.85||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.85|-7.17|0.122
71723477|NCT01942668|142963047|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.135||0.013|TWO_SIDED|95.0|-9.52|-1.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.13|-9.52|0.013
71723478|NCT01942668|142963047|SUPERIORITY||Mean Difference (Final Values)|-5.76|STANDARD_ERROR_OF_MEAN|2.08||0.006|TWO_SIDED|95.0|-9.85|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.68|-9.85|0.006
71723479|NCT01942668|142963047|SUPERIORITY||Mean Difference (Final Values)|-5.59|STANDARD_ERROR_OF_MEAN|2.132||0.009|TWO_SIDED|95.0|-9.77|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.40|-9.77|0.009
71723480|NCT01942668|142963047|SUPERIORITY||Mean Difference (Final Values)|-5.68|STANDARD_ERROR_OF_MEAN|2.093||0.007|TWO_SIDED|95.0|-9.79|-1.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.57|-9.79|0.007
71723481|NCT01942668|142963048|SUPERIORITY||Mean Difference (Final Values)|-3.39|STANDARD_ERROR_OF_MEAN|2.47||0.171|TWO_SIDED|95.0|-8.24|1.47||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.47|-8.24|0.171
71723482|NCT01942668|142963048|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|2.364||0.006|TWO_SIDED|95.0|-11.14|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.85|-11.14|0.006
71723483|NCT01942668|142963048|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_ERROR_OF_MEAN|2.434||0.003|TWO_SIDED|95.0|-12.17|-2.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.61|-12.17|0.003
71723484|NCT01942668|142963048|SUPERIORITY||Mean Difference (Final Values)|-6.69|STANDARD_ERROR_OF_MEAN|2.429||0.006|TWO_SIDED|95.0|-11.46|-1.92||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.92|-11.46|0.006
71723485|NCT01942668|142963049|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.037||0.039|TWO_SIDED|95.0|-8.21|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.21|-8.21|0.039
71723486|NCT01942668|142963049|SUPERIORITY||Mean Difference (Final Values)|-2.39|STANDARD_ERROR_OF_MEAN|1.997||0.232|TWO_SIDED|95.0|-6.31|1.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.53|-6.31|0.232
71723487|NCT01942668|142963049|SUPERIORITY||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.012||0.03|TWO_SIDED|95.0|-8.32|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-8.32|0.030
71723488|NCT01942668|142963049|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|1.973||0.262|TWO_SIDED|95.0|-6.09|1.66||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.66|-6.09|0.262
71723489|NCT01942668|142963050|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|2.119||0.011|TWO_SIDED|95.0|-9.57|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.25|-9.57|0.011
71723490|NCT01942668|142963050|SUPERIORITY||Mean Difference (Final Values)|-5.54|STANDARD_ERROR_OF_MEAN|2.065||0.008|TWO_SIDED|95.0|-9.6|-1.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.48|-9.60|0.008
71723491|NCT01942668|142963050|SUPERIORITY||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|2.115||0.007|TWO_SIDED|95.0|-9.9|-1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.59|-9.90|0.007
71723492|NCT01942668|142963050|SUPERIORITY||Mean Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|2.078||0.011|TWO_SIDED|95.0|-9.4|-1.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.24|-9.40|0.011
71723493|NCT01942668|142963051|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|2.421||0.083|TWO_SIDED|95.0|-8.96|0.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.55|-8.96|0.083
71723494|NCT01942668|142963051|SUPERIORITY||Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|2.317||0.002|TWO_SIDED|95.0|-11.91|-2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.81|-11.91|0.002
71723495|NCT01942668|142963051|SUPERIORITY||Mean Difference (Final Values)|-7.92|STANDARD_ERROR_OF_MEAN|2.384|<|0.001|TWO_SIDED|95.0|-12.6|-3.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.23|-12.60|<0.001
71830046|NCT04283552|143164446|SUPERIORITY|||||||0.001|||||||Two-tailed Wildoxon signed-rank test|||This statistical analysis is for Reader 1.||||0.001
71830047|NCT04283552|143164446|SUPERIORITY|||||||0.28|||||||Two-tailed Wilcoxon signed-rank test|||This statistical analysis is for Reader 2.||||0.28
71723496|NCT01942668|142963051|SUPERIORITY||Mean Difference (Final Values)|-6.78|STANDARD_ERROR_OF_MEAN|2.381||0.005|TWO_SIDED|95.0|-11.46|-2.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.10|-11.46|0.005
71723497|NCT01942668|142963052|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.938|TWO_SIDED|95.0|-0.12|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.12|0.938
71723498|NCT01942668|142963052|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.779|TWO_SIDED|95.0|-0.1|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.13|-0.10|0.779
71723499|NCT01942668|142963052|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.059||0.646|TWO_SIDED|95.0|-0.14|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.14|0.646
71723500|NCT01942668|142963052|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.058||0.421|TWO_SIDED|95.0|-0.07|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.07|0.421
71723501|NCT01942668|142963053|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.063||0.075|TWO_SIDED|95.0|-0.01|0.24||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.24|-0.01|0.075
71830048|NCT04283552|143164447|SUPERIORITY|||||||0.22|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.22
71830049|NCT04283552|143164447|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||>0.05
71887853|NCT01360645|143296838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0436|TWO_SIDED|95.0|-3.01|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||-0.04|-3.01|0.0436
71657447|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.58||||0.19|TWO_SIDED|95.0|-1.46|0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.29|-1.46|0.190
71723502|NCT01942668|142963053|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.062||0.074|TWO_SIDED|95.0|-0.01|0.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.23|-0.01|0.074
71723503|NCT01942668|142963053|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063||0.37|TWO_SIDED|95.0|-0.07|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.07|0.370
71723504|NCT01942668|142963053|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.062||0.851|TWO_SIDED|95.0|-0.11|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.13|-0.11|0.851
71723505|NCT01942668|142963054|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.067||0.452|TWO_SIDED|95.0|-0.18|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.18|0.452
71723506|NCT01942668|142963054|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.064||0.244|TWO_SIDED|95.0|-0.05|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.20|-0.05|0.244
71723507|NCT01942668|142963054|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.065||0.354|TWO_SIDED|95.0|-0.19|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.07|-0.19|0.354
71723508|NCT01942668|142963054|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.065||0.527|TWO_SIDED|95.0|-0.17|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.09|-0.17|0.527
71723509|NCT01942668|142963055|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-2.29|-1.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.55|-2.29|<0.001
71723510|NCT01942668|142963055|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
71723511|NCT01942668|142963055|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.07|-1.81|<0.001
71723512|NCT01942668|142963055|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.188|<|0.001|TWO_SIDED|95.0|-1.62|-0.88||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.88|-1.62|<0.001
71830050|NCT04283552|143164448|SUPERIORITY|||||||0.009|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||0.009
71830051|NCT04283552|143164448|SUPERIORITY||||||>|0.05|||||||Two-tailed Wilcoxon signed-rank test.|||This statistical analysis is for Reader 2.||||>0.05
71830052|NCT04283552|143164449|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
71830053|NCT04283552|143164449|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
71830054|NCT04283552|143164450|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 1.||||<0.001
71830055|NCT04283552|143164450|SUPERIORITY|||||||0.02|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis for Reader 2.||||0.02
71830056|NCT04283552|143164453|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 1 to PS-Late Reader 1.||||<0.001
71657448|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.66||||0.13|TWO_SIDED|95.0|-1.51|0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.20|-1.51|0.130
71830057|NCT04283552|143164453|SUPERIORITY||||||<|0.001|||||||Two-tailed Wilcoxon signed-rank test.|||This is the statistical analysis comparing PS-Early Reader 2 and PS-Late Reader 2.||||<0.001
71657449|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.22||||0.019|TWO_SIDED|95.0|-2.24|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.20|-2.24|0.019
71657450|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.53||||0.002|TWO_SIDED|95.0|-2.51|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.55|-2.51|0.002
71657451|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.39||||0.005|TWO_SIDED|95.0|-2.34|-0.43||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.43|-2.34|0.005
71657452|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.41||||0.013|TWO_SIDED|95.0|-0.73|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.09|-0.73|0.013
71830058|NCT03260140|143164471|SUPERIORITY||Mean Difference (Final Values)|-1.93||||0.001|TWO_SIDED|97.5|-3.24|-0.61|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month weight between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||-0.61|-3.24|0.001
71830059|NCT03260140|143164472|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.388|TWO_SIDED|97.5|-1.11|2.49|||Mixed Models Analysis|Difference in average SF-12 PCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.49|-1.11|0.388
71830060|NCT03260140|143164473|SUPERIORITY||Sign test|1.76||||0.308|TWO_SIDED|95.0|0.85|3.66|||F test-ratio of 2 McNemar's Chi-Squares|||Group-specific McNemar's Chi-Square tests were applied to examine the change from baseline to follow-up in dichotomized IPAQ (\>=150 vs \<150) minutes of physical activity per week. To compare intervention vs. control at 12 months, we applied an F test. The intervention effect was an odds ratio of the ratios of discordant pairs in the intervention vs the control group.||3.66|0.85|0.308
71830061|NCT03260140|143164474|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.396|TWO_SIDED|95.0|-0.61|0.24|||Mixed Models Analysis|Difference in average weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.24|-0.61|0.396
71830062|NCT03260140|143164475|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.657|TWO_SIDED|95.0|-1.02|1.61|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.61|-1.02|0.657
71657453|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.49||||0.003|TWO_SIDED|95.0|-0.8|-0.17||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1|||-0.17|-0.80|0.003
71657454|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.47||||0.017|TWO_SIDED|95.0|-0.86|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.09|-0.86|0.017
71657455|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.52||||0.009|TWO_SIDED|95.0|-0.9|-0.13||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2|||-0.13|-0.90|0.009
71657456|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.67||||0.005|TWO_SIDED|95.0|-1.13|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.20|-1.13|0.005
71657457|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.48|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4|||-0.55|-1.48|<0.001
71657458|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.47||||0.073|TWO_SIDED|95.0|-0.99|0.04||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||0.04|-0.99|0.073
71657459|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.85||||0.001|TWO_SIDED|95.0|-1.36|-0.34||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6|||-0.34|-1.36|0.001
71657460|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.89||||0.001|TWO_SIDED|95.0|-1.43|-0.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.35|-1.43|0.001
71723513|NCT01942668|142963056|SUPERIORITY||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.199|<|0.001|TWO_SIDED|95.0|-2.12|-1.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.34|-2.12|<0.001
71769519|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-45.0|||||TWO_SIDED|95.0|-54.4|-34.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-34.3|-54.4|
71769520|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.5|5.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.2|-4.5|
71769521|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.9|3.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.9|-1.9|
71769522|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-48.0|||||TWO_SIDED|95.0|-60.8|-32.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-32.0|-60.8|
71769523|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.3|10.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.1|-7.3|
71830063|NCT03260140|143164476|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.281|TWO_SIDED|95.0|-2.33|0.68|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.68|-2.33|0.281
71723514|NCT01942668|142963056|SUPERIORITY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.68|-0.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.91|-1.68|<0.001
71723515|NCT01942668|142963056|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.197|<|0.001|TWO_SIDED|95.0|-1.58|-0.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.81|-1.58|<0.001
71723516|NCT01942668|142963056|SUPERIORITY||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.198|<|0.001|TWO_SIDED|95.0|-1.34|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.57|-1.34|<0.001
71723517|NCT01942668|142963057|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-2.06|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.25|-2.06|<0.001
71723518|NCT01942668|142963057|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.87|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.07|-1.87|<0.001
71723519|NCT01942668|142963057|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.205|<|0.001|TWO_SIDED|95.0|-1.7|-0.9||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.90|-1.70|<0.001
71723520|NCT01942668|142963057|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.207|<|0.001|TWO_SIDED|95.0|-1.48|-0.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.67|-1.48|<0.001
71723521|NCT01942668|142963058|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.131||0.126|TWO_SIDED|95.0|-0.46|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.46|0.126
71769524|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.7|3.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.7|-5.7|
71887854|NCT01360645|143296838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.1903|TWO_SIDED|95.0|-2.75|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.55|-2.75|0.1903
71723522|NCT01942668|142963058|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.2|TWO_SIDED|95.0|-0.42|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.42|0.200
71723523|NCT01942668|142963058|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.222|TWO_SIDED|95.0|-0.41|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.10|-0.41|0.222
71887855|NCT01360645|143296838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47||||0.0951|TWO_SIDED|95.0|-3.21|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.26|-3.21|0.0951
71887856|NCT01360645|143296838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0626|TWO_SIDED|95.0|-3.59|0.09|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.09|-3.59|0.0626
71887857|NCT01360645|143296838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96||||0.0435|TWO_SIDED|95.0|-3.87|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||-0.06|-3.87|0.0435
71887858|NCT01360645|143296839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0069|TWO_SIDED|95.0|-2.95|-0.47|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9||-0.47|-2.95|0.0069
71887859|NCT01360645|143296839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.1322|TWO_SIDED|95.0|-2.68|0.35|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10||0.35|-2.68|0.1322
71887860|NCT01360645|143296839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.4055|TWO_SIDED|95.0|-2.41|0.98|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11||0.98|-2.41|0.4055
71887861|NCT01360645|143296839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.1715|TWO_SIDED|95.0|-3.08|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12||0.55|-3.08|0.1715
71887862|NCT01360645|143296839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.1424|TWO_SIDED|95.0|-3.33|0.48|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13||0.48|-3.33|0.1424
71723524|NCT01942668|142963058|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.358|TWO_SIDED|95.0|-0.37|0.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.37|0.358
71887863|NCT01360645|143296839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.127|TWO_SIDED|95.0|-3.52|0.44|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14||0.44|-3.52|0.1270
71657461|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.65|-0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8|||-0.56|-1.65|<0.001
71723525|NCT01942668|142963059|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.138||0.023|TWO_SIDED|95.0|-0.59|-0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.04|-0.59|0.023
71723526|NCT01942668|142963059|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.138||0.045|TWO_SIDED|95.0|-0.55|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.01|-0.55|0.045
71723527|NCT01942668|142963059|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.137||0.384|TWO_SIDED|95.0|-0.39|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.39|0.384
71723528|NCT01942668|142963059|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.424|TWO_SIDED|95.0|-0.38|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.16|-0.38|0.424
71723529|NCT01942668|142963060|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.152||0.153|TWO_SIDED|95.0|-0.52|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.52|0.153
71723530|NCT01942668|142963060|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.151||0.058|TWO_SIDED|95.0|-0.58|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.58|0.058
71723531|NCT01942668|142963060|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.151||0.55|TWO_SIDED|95.0|-0.39|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.21|-0.39|0.550
71887864|NCT01360645|143296840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3079|TWO_SIDED|95.0|-0.81|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||0.26|-0.81|0.3079
71887865|NCT01360645|143296840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4771|TWO_SIDED|95.0|-0.73|0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 14||0.34|-0.73|0.4771
71887866|NCT01360645|143296840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0195|TWO_SIDED|95.0|-0.92|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 11||-0.08|-0.92|0.0195
71887867|NCT01360645|143296840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0323|TWO_SIDED|95.0|-0.96|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 14||-0.04|-0.96|0.0323
71887868|NCT01360645|143296840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0058|TWO_SIDED|95.0|-1.07|-0.18|||Cochran-Mantel-Haenszel|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 11||-0.18|-1.07|0.0058
71887869|NCT01360645|143296840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0129|TWO_SIDED|95.0|-1.07|-0.13|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 14||-0.13|-1.07|0.0129
71830064|NCT03260140|143164477|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.483|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Difference in average score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rodgers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average score between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||0.23|-0.11|0.483
71830065|NCT03260140|143164478|SUPERIORITY||Mean percent change in HbA1c|0.02||||0.985|TWO_SIDED|95.0|-2.57|2.69|||Mixed Models Analysis|Difference in average HbA1c at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis on log-transformed HbA1c comparing the average HbA1c between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.69|-2.57|0.985
71830066|NCT03260140|143164479|SUPERIORITY||Mean Difference (Net)|-0.22||||0.806|TWO_SIDED|95.0|-1.99|1.55|||Mixed Models Analysis|Difference in average SF-12 MCS score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month MCS between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.55|-1.99|0.806
71830067|NCT03260140|143164480|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.62|TWO_SIDED|95.0|-1.77|1.05|||Mixed Models Analysis|Difference in average DBP at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average 12-month DBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||1.05|-1.77|0.620
71830068|NCT03260140|143164481|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.987|TWO_SIDED|95.0|-2.32|2.28|||Mixed Models Analysis|Difference in average SPB at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis comparing the average SBP between control and intervention groups. Our analysis controlled for randomization strata: age (less than or greater than/equal to 65), BMI (at least 30/less than 35, at least 35/less than 40, or at least 40/less than for 45), and population density (rural or urban), while random effects were used to account for within-person variability.||2.28|-2.32|0.987
71830069|NCT03401112|143164508|SUPERIORITY|||||||0.0686|||||||Log Rank|||||||0.0686
71830070|NCT03401112|143164508|SUPERIORITY|||||||0.0294|||||||Log Rank|||||||0.0294
71830071|NCT02248480|143164566|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71723532|NCT01942668|142963060|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.153||0.854|TWO_SIDED|95.0|-0.33|0.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.27|-0.33|0.854
71723533|NCT01942668|142963061|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.116||0.181|TWO_SIDED|95.0|-0.38|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.07|-0.38|0.181
71830072|NCT00732381|143164618|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||ANCOVA|||||||0.006
71723534|NCT01942668|142963061|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.116||0.108|TWO_SIDED|95.0|-0.41|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.04|-0.41|0.108
71723535|NCT01942668|142963061|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.115||0.014|TWO_SIDED|95.0|-0.51|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.06|-0.51|0.014
71723536|NCT01942668|142963061|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.115||0.323|TWO_SIDED|95.0|-0.34|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.34|0.323
71723537|NCT01942668|142963062|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.124||0.056|TWO_SIDED|95.0|-0.48|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.01|-0.48|0.056
71830073|NCT00732381|143164619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71830074|NCT02999477|143164626|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel. The test was using one-sided alpha (type I error) of 0.05. The margin is zero.||||||1|||||||McNemar|||||||1.0
71830075|NCT02999477|143164626|EQUIVALENCE|The null hypothesis is no change in the amount of PD-L1 expression from baseline to after a two-week run in of nabpaclitaxel or pembrolizumab. The test was using one-sided alpha (type I error) of 0.05.||||||1|||||||McNemar|||||||1.0
71830076|NCT03675581|143164686|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.36|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|92.83|110.67|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||110.67|92.83|
71830077|NCT03675581|143164687|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|96.4|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|91.48|101.58|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T = Test, R = Reference|||101.58|91.48|
71830078|NCT03675581|143164688|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|116.69|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|107.63|126.51|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||126.51|107.63|
71830079|NCT03675581|143164689|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|100.89|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|89.9|113.23|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||113.23|89.90|
71830080|NCT03675581|143164690|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|101.24|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|93.95|109.1|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||109.10|93.95|
71830081|NCT03675581|143164691|OTHER|Relative systemic exposure|Ratio of the geometric means (T/R) %|88.09|STANDARD_DEVIATION|15.0|||TWO_SIDED|90.0|80.03|96.96|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||96.96|80.03|
71830082|NCT01424397|143164692|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with FP alone compared to Placebo using Mixed Models Analysis was 1.0000|||
71723538|NCT01942668|142963062|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.124||0.279|TWO_SIDED|95.0|-0.38|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.38|0.279
71723539|NCT01942668|142963062|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.123||0.435|TWO_SIDED|95.0|-0.34|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.15|-0.34|0.435
71723540|NCT01942668|142963062|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.124||0.607|TWO_SIDED|95.0|-0.31|0.18||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.31|0.607
71723541|NCT01942668|142963063|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.138||0.06|TWO_SIDED|95.0|-0.53|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.01|-0.53|0.060
71887870|NCT01360645|143296841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.5151|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 11||0.36|-0.71|0.5151
71887871|NCT01360645|143296841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.608|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 14||0.41|-0.70|0.6080
71723542|NCT01942668|142963063|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.137||0.026|TWO_SIDED|95.0|-0.57|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.04|-0.57|0.026
71723543|NCT01942668|142963063|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.136||0.097|TWO_SIDED|95.0|-0.49|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.04|-0.49|0.097
71723544|NCT01942668|142963063|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.138||0.23|TWO_SIDED|95.0|-0.44|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-0.44|0.230
71723545|NCT01942668|142963064|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.107|TWO_SIDED|95.0|-0.61|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.61|0.107
71723546|NCT01942668|142963064|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.169||0.302|TWO_SIDED|95.0|-0.51|0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.51|0.302
71723547|NCT01942668|142963064|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.169||0.106|TWO_SIDED|95.0|-0.6|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.06|-0.60|0.106
71723548|NCT01942668|142963064|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.169||0.156|TWO_SIDED|95.0|-0.57|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.09|-0.57|0.156
71723549|NCT01942668|142963065|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.177||0.081|TWO_SIDED|95.0|-0.65|0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.04|-0.65|0.081
71830083|NCT01424397|143164692|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 alone compared to Placebo using Mixed Models Analysis was 0.7127|||
71830084|NCT01424397|143164692|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to Placebo using Mixed Models Analysis was 1.0000|||
71830085|NCT01424397|143164692|SUPERIORITY_OR_OTHER||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to FP alone using Mixed Models Analysis was 0.0160|||
71830086|NCT01424397|143164694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.35|STANDARD_ERROR_OF_MEAN|12.56|||TWO_SIDED|90.0|60.54|102.15||||||Placebo versus FP 200 μg,Nasal Airflow resistance Total WM,0-4 hr||102.15|60.54|
71887872|NCT01360645|143296841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0267|TWO_SIDED|95.0|-0.92|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 11||-0.06|-0.92|0.0267
71723550|NCT01942668|142963065|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.175||0.212|TWO_SIDED|95.0|-0.56|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.12|-0.56|0.212
71723551|NCT01942668|142963065|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.175||0.345|TWO_SIDED|95.0|-0.51|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.51|0.345
71830087|NCT01424397|143164694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.31|STANDARD_ERROR_OF_MEAN|19.548|||TWO_SIDED|90.0|-39.7|25.05||||||Placebo versus FP 12 mg SB-705498 , Nasal Airflow resistance Total WM, 0-4 hr||25.05|-39.7|
71830088|NCT01424397|143164694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.4|STANDARD_ERROR_OF_MEAN|14.567|||TWO_SIDED|90.0|48.28|96.52||||||Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||96.52|48.28|
71830089|NCT01424397|143164694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.95|STANDARD_ERROR_OF_MEAN|14.592|||TWO_SIDED|90.0|-33.1|15.22||||||FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr||15.22|-33.1|
71830090|NCT01424397|143164695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.113|||TWO_SIDED|90.0|-0.87|-0.49||||||||-0.49|-0.87|
71723552|NCT01942668|142963065|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.176||0.829|TWO_SIDED|95.0|-0.38|0.31||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.31|-0.38|0.829
71723553|NCT01942668|142963066|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.201||0.029|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.029
71723554|NCT01942668|142963066|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.199||0.026|TWO_SIDED|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.05|-0.84|0.026
71723555|NCT01942668|142963066|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.199||0.093|TWO_SIDED|95.0|-0.72|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.06|-0.72|0.093
71830091|NCT01424397|143164695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.173|||TWO_SIDED|90.0|-0.3|0.27||||||||0.27|-0.30|
71830092|NCT01424397|143164695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.74|-0.31||||||||-0.31|-0.74|
71830093|NCT01424397|143164695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.06|0.37||||||||0.37|-0.06|
71830094|NCT01254019|143164758|SUPERIORITY||Mean Difference (Net)|10.334||||0.415|TWO_SIDED|95.0|-14.645|35.312||Statistical significance was assessed at the 5% level.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||35.312|-14.645|0.415
71830095|NCT01254019|143164759|SUPERIORITY||Mean Difference (Net)|-0.53||||0.757|TWO_SIDED|95.0|-3.95|2.88||Statistical significance (SS) was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||2.88|-3.95|0.757
71887873|NCT01360645|143296841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0224|TWO_SIDED|95.0|-1.01|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 14||-0.08|-1.01|0.0224
71887874|NCT01360645|143296841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0146|TWO_SIDED|95.0|-1.01|-0.11|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 11||-0.11|-1.01|0.0146
71887875|NCT01360645|143296841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0113|TWO_SIDED|95.0|-1.09|-0.14|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 14||-0.14|-1.09|0.0113
71887876|NCT01360645|143296842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.34||||0.0001|TWO_SIDED|95.0|-3.47|-1.22|||ANCOVA|||ANCOVA\_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-1.22|-3.47|0.0001
71887877|NCT01360645|143296843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0002|TWO_SIDED|95.0|-3.47|-1.12|||ANCOVA|||||-1.12|-3.47|0.0002
71887878|NCT01360645|143296844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0219|TWO_SIDED|95.0|-2.17|-0.17|||ANCOVA|||ANCOVA\_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A \[Week 8\]) value as a covariate was used.||-0.17|-2.17|0.0219
71887879|NCT01360645|143296845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0376|TWO_SIDED|95.0|-2.13|-0.06|||ANCOVA|||||-0.06|-2.13|0.0376
71887880|NCT01360645|143296846|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.63||||0.0176|TWO_SIDED|95.0|1.09|2.44|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.44|1.09|0.0176
71887881|NCT01360645|143296847|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.54||||0.0429|TWO_SIDED|95.0|1.01|2.35|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.35|1.01|0.0429
71887882|NCT01360645|143296848|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.68||||0.0586|TWO_SIDED|95.0|0.98|2.86|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.86|0.98|0.0586
71887883|NCT01360645|143296849|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0671|TWO_SIDED|95.0|0.97|2.9|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.90|0.97|0.0671
71887884|NCT01360645|143296850|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.61||||0.0003|TWO_SIDED|95.0|1.23|2.1|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.10|1.23|0.0003
71887885|NCT01360645|143296851|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.69||||0.0002|TWO_SIDED|95.0|1.27|2.27|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.||||2.27|1.27|0.0002
71830096|NCT01254019|143164760|SUPERIORITY||Mean Difference (Net)|-0.021||||0.718|TWO_SIDED|95.0|-0.137|0.095||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.095|-0.137|0.718
71830097|NCT01254019|143164761|SUPERIORITY||Mean Difference (Net)|-0.009||||0.881|TWO_SIDED|95.0|-0.129|0.111||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.111|-0.129|0.881
71830098|NCT01254019|143164762|SUPERIORITY||Mean Difference (Net)|-1.115||||0.658|TWO_SIDED|95.0|-6.097|3.866||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||3.866|-6.097|0.658
71830099|NCT01254019|143164763|SUPERIORITY||Mean Difference (Net)|0.041||||0.513|TWO_SIDED|95.0|-0.082|0.164||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||0.164|-0.082|0.513
71830100|NCT01254019|143164764|SUPERIORITY||Mean Difference (Net)|-0.965||||0.769|TWO_SIDED|95.0|-7.446|5.516||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||5.516|-7.446|0.769
71830101|NCT01254019|143164767|SUPERIORITY||Mean Difference (Net)|-4044.99||||0|TWO_SIDED|95.0|-5232.21|-2857.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo||-2857.77|-5232.21|0.000
71723556|NCT01942668|142963066|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.202||0.223|TWO_SIDED|95.0|-0.64|0.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.64|0.223
71723557|NCT01942668|142963067|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.4||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.40|-0.85|<0.001
71830102|NCT01254019|143164773|SUPERIORITY||Mean Difference (Net)|0.0288||||0.207|TWO_SIDED|95.0|-0.0161|0.0738||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI2 at Week 48||0.0738|-0.0161|0.207
71830103|NCT01254019|143164773|SUPERIORITY||Mean Difference (Net)|0.0048||||0.88|TWO_SIDED|95.0|-0.058|0.0676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI3 at Week 48||0.0676|-0.0580|0.880
71830104|NCT03061474|143164782|SUPERIORITY|||||||0.6096|||||||ANCOVA|||||||0.6096
71723558|NCT01942668|142963067|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.71|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-0.71|<0.001
71723559|NCT01942668|142963067|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.75|-0.3||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.30|-0.75|<0.001
71723560|NCT01942668|142963067|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.64|-0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.20|-0.64|<0.001
71723561|NCT01942668|142963068|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.85|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.38|-0.85|<0.001
71830105|NCT03061474|143164792|SUPERIORITY|||||||0.648|||||||ANCOVA|||||||0.648
71830106|NCT03061474|143164793|SUPERIORITY|||||||0.6833|||||||ANCOVA|||||||0.6833
71830107|NCT03061474|143164794|SUPERIORITY|||||||0.4438|||||||ANCOVA|||||||0.4438
71830108|NCT03061474|143164795|SUPERIORITY|||||||0.7158|||||||ANCOVA|||||||0.7158
71830109|NCT03061474|143164796|SUPERIORITY|||||||0.93428359|||||||ANCOVA|||||||0.93428359
71830110|NCT03061474|143164797|SUPERIORITY|||||||0.9931|||||||ANCOVA|||||||0.9931
71830111|NCT03061474|143164798|SUPERIORITY|||||||0.3233|||||||Mixed Models Analysis|||||||0.3233
71830112|NCT03061474|143164799|SUPERIORITY|||||||0.1008|||||||Mixed Models Analysis|||||||0.1008
71830113|NCT03061474|143164800|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
71657462|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.68||||0.039|TWO_SIDED|95.0|-1.32|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.03|-1.32|0.039
71723562|NCT01942668|142963068|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.22|-0.69|<0.001
71723563|NCT01942668|142963068|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.59|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.12|-0.59|0.003
71723564|NCT01942668|142963068|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.03|TWO_SIDED|95.0|-0.5|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-0.03|-0.50|0.030
71723565|NCT01942668|142963069|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.89|-0.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.89|<0.001
71723566|NCT01942668|142963069|SUPERIORITY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.88|-0.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.36|-0.88|<0.001
71723567|NCT01942668|142963069|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.73|-0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.21|-0.73|<0.001
71723568|NCT01942668|142963069|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.006|TWO_SIDED|95.0|-0.63|-0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-0.10|-0.63|0.006
71723569|NCT01942668|142963070|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.629||0.003|TWO_SIDED|95.0|-8.08|-1.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.69|-8.08|0.003
71723570|NCT01942668|142963070|SUPERIORITY||Mean Difference (Final Values)|-3.61|STANDARD_ERROR_OF_MEAN|1.626||0.027|TWO_SIDED|95.0|-6.8|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.42|-6.80|0.027
71723571|NCT01942668|142963070|SUPERIORITY||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.618||0.034|TWO_SIDED|95.0|-6.61|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.26|-6.61|0.034
71723572|NCT01942668|142963070|SUPERIORITY||Mean Difference (Final Values)|-2.53|STANDARD_ERROR_OF_MEAN|1.621||0.119|TWO_SIDED|95.0|-5.71|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.71|0.119
71769525|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-41.0|||||TWO_SIDED|95.0|-53.3|-25.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-25.5|-53.3|
71769526|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.8|8.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.1|-4.8|
71723573|NCT01942668|142963071|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.7||0.002|TWO_SIDED|95.0|-8.73|-2.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.05|-8.73|0.002
71723574|NCT01942668|142963071|SUPERIORITY||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|1.696||0.002|TWO_SIDED|95.0|-8.72|-2.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.06|-8.72|0.002
71723575|NCT01942668|142963071|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|1.685||0.004|TWO_SIDED|95.0|-8.19|-1.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.58|-8.19|0.004
71723576|NCT01942668|142963071|SUPERIORITY||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|1.698||0.009|TWO_SIDED|95.0|-7.75|-1.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.09|-7.75|0.009
71723577|NCT01942668|142963072|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.855|<|0.001|TWO_SIDED|95.0|-10.18|-2.9||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.90|-10.18|<0.001
71723578|NCT01942668|142963072|SUPERIORITY||Mean Difference (Final Values)|-7.61|STANDARD_ERROR_OF_MEAN|1.843|<|0.001|TWO_SIDED|95.0|-11.23|-4.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.00|-11.23|<0.001
71723579|NCT01942668|142963072|SUPERIORITY||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.04|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.04|<0.001
71723580|NCT01942668|142963072|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.41|-3.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.10|-10.41|<0.001
71723581|NCT01942668|142963073|SUPERIORITY||Mean Difference (Final Values)|-7.34|STANDARD_ERROR_OF_MEAN|2.146|<|0.001|TWO_SIDED|95.0|-11.55|-3.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-3.13|-11.55|<0.001
71657463|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.91|-0.63||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12|||-0.63|-1.91|<0.001
71887886|NCT01014585|143296852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44||||0.0004|TWO_SIDED|95.0|0.27|0.71|||Log Rank|||||0.71|0.27|0.0004
71887887|NCT01014585|143296852|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
71657464|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.77||||0.073|TWO_SIDED|95.0|-1.61|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||0.07|-1.61|0.073
71657465|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.11||||0.007|TWO_SIDED|95.0|-1.91|-0.3||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16|||-0.30|-1.91|0.007
71657466|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.77||||0.083|TWO_SIDED|95.0|-1.65|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.10|-1.65|0.083
71657467|NCT02504671|142831742|OTHER||Mean Difference (Net)|-0.8||||0.059|TWO_SIDED|95.0|-1.63|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20|||0.03|-1.63|0.059
71657468|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.48||||0.003|TWO_SIDED|95.0|-2.46|-0.5||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.50|-2.46|0.003
71657469|NCT02504671|142831742|OTHER||Mean Difference (Net)|-1.82|||<|0.001|TWO_SIDED|95.0|-2.75|-0.89||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24|||-0.89|-2.75|<0.001
71657470|NCT02504671|142831744|OTHER||Difference|16.2||||0.037|TWO_SIDED|95.0|1.1|31.4|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.4|1.1|0.037
71657471|NCT02504671|142831744|OTHER||Difference|10.8||||0.144|TWO_SIDED|95.0|-3.1|24.7|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|0.144
71657472|NCT02504671|142831744|OTHER||Difference|18.9||||0.033|TWO_SIDED|95.0|3.3|34.5|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|0.033
71657473|NCT02504671|142831744|OTHER||Difference|5.4||||0.437|TWO_SIDED|95.0|-11.3|22.2|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||22.2|-11.3|0.437
71657474|NCT02504671|142831744|OTHER||Difference|2.7||||0.755|TWO_SIDED|95.0|-13.5|18.9|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||18.9|-13.5|0.755
71657475|NCT02504671|142831744|OTHER||Difference|24.3||||0.023|TWO_SIDED|95.0|5.2|43.4|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|0.023
71657476|NCT02504671|142831744|OTHER||Difference|29.7||||0.006|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.006
71657477|NCT02504671|142831744|OTHER||Difference|21.6||||0.039|TWO_SIDED|95.0|2.0|41.2|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|0.039
71657478|NCT02504671|142831744|OTHER||Difference|29.7||||0.008|TWO_SIDED|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|0.008
71657479|NCT02504671|142831744|OTHER||Difference|21.6||||0.044|TWO_SIDED|95.0|0.4|42.8|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|0.044
71657480|NCT02504671|142831744|OTHER||Difference|18.9||||0.083|TWO_SIDED|95.0|-2.2|40.0|||Regression, Logistic||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||40.0|-2.2|0.083
71657481|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.8|48.3|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.3|5.8|
71657482|NCT02504671|142831744|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-11.2|32.8|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.Wald confidence limits without correction.|||32.8|-11.2|
71657483|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
71657484|NCT02504671|142831744|OTHER||Difference|32.4|||||TWO_SIDED|95.0|10.9|54.0|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||54.0|10.9|
71657485|NCT02504671|142831744|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
71657486|NCT02504671|142831744|OTHER||Difference|29.7|||||TWO_SIDED|95.0|8.9|50.6|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||50.6|8.9|
71887888|NCT01014585|143296852|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|45.0||||||95.0||||||||||||
71887889|NCT01014585|143296853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.0002|TWO_SIDED|95.0|0.2|0.63|||Log Rank|||||0.63|0.20|0.0002
71887890|NCT01014585|143296853|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|22.0||||||95.0||||||||||||
71887891|NCT01014585|143296854|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.4104|TWO_SIDED|95.0|0.46|1.38|||Log Rank|||||1.38|0.46|0.4104
71887892|NCT01014585|143296854|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|18.0||||||95.0||||||||||||
71887893|NCT01014585|143296854|SUPERIORITY_OR_OTHER||Days until LTR at the 25th percentile|30.0||||||95.0||||||||||||
71887894|NCT00508391|143296884|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.|Objective Performance Criteria|63.0|||||ONE_SIDED|95.0|54.8||||Non-inferiority comparison|||"Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as not worsened after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.~An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as not worsened after changing from optimized to simultaneous biventricular pacing."|||54.8|
71887895|NCT00508391|143296885|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.|Objective Performance Criteria|100.0|||||ONE_SIDED|95.0|97.6||||Non-inferiority comparison|||Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%|||97.6|
71887896|NCT01225562|143296899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.008|TWO_SIDED|95.0|0.75|0.96|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||0.96|0.75|0.0080
71887897|NCT01225562|143296899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0043|TWO_SIDED|95.0|0.74|0.95|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||0.95|0.74|0.0043
71723582|NCT01942668|142963073|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.139||0.009|TWO_SIDED|95.0|-9.8|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.40|-9.80|0.009
71723583|NCT01942668|142963073|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|2.132||0.016|TWO_SIDED|95.0|-9.31|-0.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.95|-9.31|0.016
71887898|NCT01225562|143296900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1547|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.06|0.71|0.1547
71887899|NCT01225562|143296900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0676|TWO_SIDED|95.0|0.68|1.01|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.01|0.68|0.0676
71887900|NCT01225562|143296901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9851|TWO_SIDED|95.0|0.86|1.16|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||1.16|0.86|0.9851
71723584|NCT01942668|142963073|SUPERIORITY||Mean Difference (Final Values)|-3.04|STANDARD_ERROR_OF_MEAN|2.13||0.154|TWO_SIDED|95.0|-7.22|1.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||1.14|-7.22|0.154
71723585|NCT01942668|142963074|SUPERIORITY||Mean Difference (Final Values)|-8.38|STANDARD_ERROR_OF_MEAN|2.213|<|0.001|TWO_SIDED|95.0|-12.72|-4.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-4.04|-12.72|<0.001
71887901|NCT01225562|143296901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.135|TWO_SIDED|95.0|0.76|1.04|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||1.04|0.76|0.1350
71887902|NCT01225562|143296902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.96|3.7|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard|||3.70|1.96|<0.0001
71887903|NCT01225562|143296902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.68|3.21|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard|||3.21|1.68|<0.0001
71887904|NCT01162421|143296914|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3||||0.907|TWO_SIDED|95.0|-23.4|20.8|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||||20.8|-23.4|0.907
71887905|NCT01162421|143296915|SUPERIORITY_OR_OTHER||Difference in percentage|3.2||||0.762|TWO_SIDED|95.0|-17.7|24.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||24.1|-17.7|0.762
71887906|NCT01162421|143296915|SUPERIORITY_OR_OTHER||Difference in percentage|-5.3||||0.65|TWO_SIDED|95.0|-28.1|17.5|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||17.5|-28.1|0.650
71887907|NCT01162421|143296916|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.382||0.027|TWO_SIDED|95.0|-1.62|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 6||-0.10|-1.62|0.027
71887908|NCT01162421|143296916|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.667||0.033|TWO_SIDED|95.0|-2.79|-0.12||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 12||-0.12|-2.79|0.033
71769527|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-0.6|7.8|||Miettinen and Nurminen score methodx|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-0.6|
71723586|NCT01942668|142963074|SUPERIORITY||Mean Difference (Final Values)|-7.52|STANDARD_ERROR_OF_MEAN|2.201|<|0.001|TWO_SIDED|95.0|-11.83|-3.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.20|-11.83|<0.001
71723587|NCT01942668|142963074|SUPERIORITY||Mean Difference (Final Values)|-7.32|STANDARD_ERROR_OF_MEAN|2.193|<|0.001|TWO_SIDED|95.0|-11.63|-3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-3.02|-11.63|<0.001
71723588|NCT01942668|142963074|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.207||0.011|TWO_SIDED|95.0|-9.93|-1.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.27|-9.93|0.011
71723589|NCT01942668|142963075|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.439|<|0.001|TWO_SIDED|95.0|-13.76|-4.19||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.19|-13.76|<0.001
71723590|NCT01942668|142963075|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-14.34|-4.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.85|-14.34|<0.001
71723591|NCT01942668|142963075|SUPERIORITY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|2.412|<|0.001|TWO_SIDED|95.0|-14.03|-4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-4.56|-14.03|<0.001
71723592|NCT01942668|142963075|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.442||0.002|TWO_SIDED|95.0|-12.51|-2.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.93|-12.51|0.002
71830114|NCT03299816|143164825|SUPERIORITY|||||||0.17||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.17
71830115|NCT03299816|143164826|SUPERIORITY|||||||0.36||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.36
71830116|NCT03299816|143164827|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.33
71723593|NCT01942668|142963076|SUPERIORITY||Mean Difference (Final Values)|2.02|STANDARD_ERROR_OF_MEAN|2.576||0.434|TWO_SIDED|95.0|-3.03|7.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.07|-3.03|0.434
71723594|NCT01942668|142963076|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.564||0.442|TWO_SIDED|95.0|-3.06|7.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.00|-3.06|0.442
71723595|NCT01942668|142963076|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|2.558||0.558|TWO_SIDED|95.0|-3.52|6.51||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.51|-3.52|0.558
71723596|NCT01942668|142963076|SUPERIORITY||Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.555||0.534|TWO_SIDED|95.0|-3.42|6.6||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||6.60|-3.42|0.534
71723597|NCT01942668|142963077|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|2.719||0.927|TWO_SIDED|95.0|-5.08|5.58||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||5.58|-5.08|0.927
71723598|NCT01942668|142963077|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.699||0.541|TWO_SIDED|95.0|-6.95|3.64||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-6.95|0.541
71723599|NCT01942668|142963077|SUPERIORITY||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|2.691||0.171|TWO_SIDED|95.0|-8.96|1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||1.60|-8.96|0.171
71723600|NCT01942668|142963077|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.708||0.667|TWO_SIDED|95.0|-6.48|4.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||4.15|-6.48|0.667
71723601|NCT01942668|142963078|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.863||0.662|TWO_SIDED|95.0|-4.36|6.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||6.87|-4.36|0.662
71723602|NCT01942668|142963078|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|2.834||0.635|TWO_SIDED|95.0|-6.91|4.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||4.21|-6.91|0.635
71830117|NCT03299816|143164828|SUPERIORITY|||||||0.61||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.61
71830118|NCT03299816|143164829|SUPERIORITY|||||||0.73||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|Urinary albumin-to-creatinine ratio (ACR) was not normally distributed and was natural log transformed for analyses||||||0.73
71830119|NCT03299816|143164830|SUPERIORITY|||||||0.75||||||The a priori threshold for statistical significance was \<0.05|Mixed effects regression|||||||0.75
71830120|NCT02311907|143164831|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Generalized linear models (repeated measures analysis of variance \[ANOVA\]) will be used to compare the CIPN between GSH and placebo arms.||||0.21
71723603|NCT01942668|142963078|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.827||0.877|TWO_SIDED|95.0|-5.98|5.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.11|-5.98|0.877
71723604|NCT01942668|142963078|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|2.867||0.893|TWO_SIDED|95.0|-6.01|5.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||5.24|-6.01|0.893
71723605|NCT01942668|142963079|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.058||0.83|TWO_SIDED|95.0|-4.48|3.59||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.59|-4.48|0.830
71723606|NCT01942668|142963079|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|2.05||0.755|TWO_SIDED|95.0|-4.66|3.38||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||3.38|-4.66|0.755
71723607|NCT01942668|142963079|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.046||0.802|TWO_SIDED|95.0|-3.5|4.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||4.53|-3.50|0.802
71723608|NCT01942668|142963079|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|2.043||0.823|TWO_SIDED|95.0|-4.46|3.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-4.46|0.823
71723609|NCT01942668|142963080|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.166||0.255|TWO_SIDED|95.0|-6.71|1.78||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.78|-6.71|0.255
71723610|NCT01942668|142963080|SUPERIORITY||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|2.154||0.293|TWO_SIDED|95.0|-6.49|1.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||1.96|-6.49|0.293
71723611|NCT01942668|142963080|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.148||0.502|TWO_SIDED|95.0|-5.66|2.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.77|-5.66|0.502
71723612|NCT01942668|142963080|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.161||0.495|TWO_SIDED|95.0|-5.71|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.76|-5.71|0.495
71723613|NCT01942668|142963081|SUPERIORITY||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.274||0.389|TWO_SIDED|95.0|-6.42|2.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||2.50|-6.42|0.389
71723614|NCT01942668|142963081|SUPERIORITY||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.253||0.281|TWO_SIDED|95.0|-6.85|1.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||1.99|-6.85|0.281
71723615|NCT01942668|142963081|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.25||0.504|TWO_SIDED|95.0|-5.92|2.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.91|-5.92|0.504
71723616|NCT01942668|142963081|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.277||0.46|TWO_SIDED|95.0|-6.15|2.78||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||2.78|-6.15|0.460
71723617|NCT01942668|142963082|SUPERIORITY||Mean Difference (Final Values)|4.35|STANDARD_ERROR_OF_MEAN|2.513||0.084|TWO_SIDED|95.0|-0.58|9.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||9.28|-0.58|0.084
71723618|NCT01942668|142963082|SUPERIORITY||Mean Difference (Final Values)|2.61|STANDARD_ERROR_OF_MEAN|2.506||0.298|TWO_SIDED|95.0|-2.3|7.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||7.53|-2.30|0.298
71723619|NCT01942668|142963082|SUPERIORITY||Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|2.496||0.136|TWO_SIDED|95.0|-1.17|8.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.62|-1.17|0.136
71723620|NCT01942668|142963082|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.492||0.163|TWO_SIDED|95.0|-1.41|8.37||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||8.37|-1.41|0.163
71723621|NCT01942668|142963083|SUPERIORITY||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.647||0.054|TWO_SIDED|95.0|-0.08|10.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||10.31|-0.08|0.054
71723622|NCT01942668|142963083|SUPERIORITY||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|2.634||0.007|TWO_SIDED|95.0|1.93|12.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||12.26|1.93|0.007
71723623|NCT01942668|142963083|SUPERIORITY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|2.623||0.025|TWO_SIDED|95.0|0.75|11.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||11.04|0.75|0.025
71723624|NCT01942668|142963083|SUPERIORITY||Mean Difference (Final Values)|8.38|STANDARD_ERROR_OF_MEAN|2.638||0.002|TWO_SIDED|95.0|3.2|13.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||13.55|3.20|0.002
71830121|NCT02311907|143164832|SUPERIORITY_OR_OTHER|||||||0.63|||||||Log Rank|||||||0.63
71830122|NCT03520413|143164840|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.12|-0.11|||Mixed Models Analysis|||||-0.11|-1.12|0.02
71830123|NCT03520413|143164841|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-0.25||||0.007|TWO_SIDED|95.0|-0.42|-0.07|||Mixed Models Analysis|||||-0.07|-0.42|0.007
71830124|NCT03520413|143164842|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.51||||0.0002|TWO_SIDED|95.0|0.25|0.78|||Mixed Models Analysis|||||0.78|0.25|0.0002
71657487|NCT02504671|142831744|OTHER||Difference|45.9|||||TWO_SIDED|95.0|25.9|66.0|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||66.0|25.9|
71657488|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
71657489|NCT02504671|142831744|OTHER||Difference|32.4|||||TWO_SIDED|95.0|11.6|53.3|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||53.3|11.6|
71657490|NCT02504671|142831744|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.2|58.5|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||58.5|17.2|
71657491|NCT02504671|142831744|OTHER||Difference|18.9|||||TWO_SIDED|95.0|-0.5|38.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.4|-0.5|
71657492|NCT02504671|142831744|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
71657493|NCT02504671|142831744|OTHER||Difference|48.6|||||TWO_SIDED|95.0|29.2|68.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.1|29.2|
71657494|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-3.0|35.4|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.4|-3.0|
71657495|NCT02504671|142831744|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
71657496|NCT02504671|142831744|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
71657497|NCT02504671|142831744|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657498|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657499|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657500|NCT02504671|142831744|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657501|NCT02504671|142831744|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657502|NCT02504671|142831744|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657503|NCT02504671|142831744|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657504|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657505|NCT02504671|142831744|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657506|NCT02504671|142831744|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657507|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657508|NCT02504671|142831744|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657509|NCT02504671|142831744|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657510|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657511|NCT02504671|142831744|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657512|NCT02504671|142831744|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657513|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657514|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657515|NCT02504671|142831744|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71830125|NCT03520413|143164843|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|0.39||||0.02|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.02
71723625|NCT01942668|142963084|SUPERIORITY||Mean Difference (Final Values)|5.02|STANDARD_ERROR_OF_MEAN|2.945||0.089|TWO_SIDED|95.0|-0.76|10.8||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||10.80|-0.76|0.089
71723626|NCT01942668|142963084|SUPERIORITY||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|2.92||0.01|TWO_SIDED|95.0|1.83|13.29||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||13.29|1.83|0.010
71723627|NCT01942668|142963084|SUPERIORITY||Mean Difference (Final Values)|7.65|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|1.94|13.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.36|1.94|0.009
71723628|NCT01942668|142963084|SUPERIORITY||Mean Difference (Final Values)|7.89|STANDARD_ERROR_OF_MEAN|2.944||0.007|TWO_SIDED|95.0|2.11|13.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||13.67|2.11|0.007
71723629|NCT01942668|142963085|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.749||0.349|TWO_SIDED|95.0|-5.07|1.79||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||1.79|-5.07|0.349
71769528|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-15.9|4.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.6|-15.9|
71723630|NCT01942668|142963085|SUPERIORITY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|1.743||0.499|TWO_SIDED|95.0|-4.6|2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||2.24|-4.60|0.499
71723631|NCT01942668|142963085|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.737||0.936|TWO_SIDED|95.0|-3.27|3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||3.55|-3.27|0.936
71723632|NCT01942668|142963085|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.736||0.696|TWO_SIDED|95.0|-4.08|2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||2.72|-4.08|0.696
71723633|NCT01942668|142963086|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.924||0.572|TWO_SIDED|95.0|-4.86|2.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.69|-4.86|0.572
71723634|NCT01942668|142963086|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.914||0.553|TWO_SIDED|95.0|-4.89|2.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||2.62|-4.89|0.553
71723635|NCT01942668|142963086|SUPERIORITY||Mean Difference (Final Values)|-1.42|STANDARD_ERROR_OF_MEAN|1.907||0.456|TWO_SIDED|95.0|-5.16|2.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||2.32|-5.16|0.456
71723636|NCT01942668|142963086|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|1.919||0.949|TWO_SIDED|95.0|-3.89|3.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||3.64|-3.89|0.949
71723637|NCT01942668|142963087|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|2.026||0.097|TWO_SIDED|95.0|-7.34|0.61||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.61|-7.34|0.097
71723638|NCT01942668|142963087|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.01||0.008|TWO_SIDED|95.0|-9.28|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.40|-9.28|0.008
71723639|NCT01942668|142963087|SUPERIORITY||Mean Difference (Final Values)|-4.94|STANDARD_ERROR_OF_MEAN|2.003||0.014|TWO_SIDED|95.0|-8.87|-1.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-1.01|-8.87|0.014
71723640|NCT01942668|142963087|SUPERIORITY||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.029||0.056|TWO_SIDED|95.0|-7.86|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.10|-7.86|0.056
71723641|NCT01942668|142963088|SUPERIORITY||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|1.665||0.003|TWO_SIDED|95.0|-8.18|-1.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.65|-8.18|0.003
71723642|NCT01942668|142963088|SUPERIORITY||Mean Difference (Final Values)|-3.79|STANDARD_ERROR_OF_MEAN|1.66||0.023|TWO_SIDED|95.0|-7.05|-0.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.53|-7.05|0.023
71887909|NCT01162421|143296916|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.22|STANDARD_ERROR_OF_MEAN|1.403||0.12|TWO_SIDED|95.0|-5.05|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|||Month 24||0.60|-5.05|0.120
71887910|NCT01162421|143296917|SUPERIORITY_OR_OTHER||Difference in percentage|-11.7||||0.095|TWO_SIDED|95.0|-27.0|1.6||P-value is based on two sided Fisher's exact test.|Fisher Exact||Confidence interval is based on Wilson confidence limits.|||1.6|-27.0|0.095
71887911|NCT01162421|143296918|SUPERIORITY_OR_OTHER||Difference in percentage|12.1||||0.281|TWO_SIDED|95.0|-9.79|33.97|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.97|-9.79|0.281
71887912|NCT01162421|143296918|SUPERIORITY_OR_OTHER||Difference in percentage|27.0||||0.021|TWO_SIDED|95.0|4.98|48.93||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||48.93|4.98|0.021
71657516|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71723643|NCT01942668|142963088|SUPERIORITY||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|1.653||0.047|TWO_SIDED|95.0|-6.52|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.04|-6.52|0.047
71723644|NCT01942668|142963088|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_ERROR_OF_MEAN|1.652||0.039|TWO_SIDED|95.0|-6.65|-0.17||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.17|-6.65|0.039
71723645|NCT01942668|142963089|SUPERIORITY||Mean Difference (Final Values)|-5.69|STANDARD_ERROR_OF_MEAN|1.713|<|0.001|TWO_SIDED|95.0|-9.05|-2.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.33|-9.05|<0.001
71723646|NCT01942668|142963089|SUPERIORITY||Mean Difference (Final Values)|-5.58|STANDARD_ERROR_OF_MEAN|1.704||0.001|TWO_SIDED|95.0|-8.93|-2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.24|-8.93|0.001
71723647|NCT01942668|142963089|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.697||0.003|TWO_SIDED|95.0|-8.45|-1.79||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.79|-8.45|0.003
71723648|NCT01942668|142963089|SUPERIORITY||Mean Difference (Final Values)|-5.11|STANDARD_ERROR_OF_MEAN|1.708||0.003|TWO_SIDED|95.0|-8.46|-1.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.76|-8.46|0.003
71657517|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657518|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71723649|NCT01942668|142963090|SUPERIORITY||Mean Difference (Final Values)|-6.01|STANDARD_ERROR_OF_MEAN|1.885||0.001|TWO_SIDED|95.0|-9.71|-2.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.32|-9.71|0.001
71723650|NCT01942668|142963090|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|1.871|<|0.001|TWO_SIDED|95.0|-10.89|-3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.55|-10.89|<0.001
71723651|NCT01942668|142963090|SUPERIORITY||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|1.863|<|0.001|TWO_SIDED|95.0|-10.58|-3.27||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.27|-10.58|<0.001
71723652|NCT01942668|142963090|SUPERIORITY||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.886|<|0.001|TWO_SIDED|95.0|-10.12|-2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.72|-10.12|<0.001
71723653|NCT01942668|142963091|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.609||0.004|TWO_SIDED|95.0|-7.75|-1.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-1.44|-7.75|0.004
71723654|NCT01942668|142963091|SUPERIORITY||Mean Difference (Final Values)|-3.49|STANDARD_ERROR_OF_MEAN|1.605||0.03|TWO_SIDED|95.0|-6.64|-0.34||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.34|-6.64|0.030
71723655|NCT01942668|142963091|SUPERIORITY||Mean Difference (Final Values)|-3.15|STANDARD_ERROR_OF_MEAN|1.598||0.049|TWO_SIDED|95.0|-6.29|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||-0.02|-6.29|0.049
71723656|NCT01942668|142963091|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|1.597||0.121|TWO_SIDED|95.0|-5.61|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.65|-5.61|0.121
71723657|NCT01942668|142963092|SUPERIORITY||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|1.682||0.001|TWO_SIDED|95.0|-8.74|-2.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.14|-8.74|0.001
71723658|NCT01942668|142963092|SUPERIORITY||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-8.81|-2.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||-2.25|-8.81|<0.001
71723659|NCT01942668|142963092|SUPERIORITY||Mean Difference (Final Values)|-5.12|STANDARD_ERROR_OF_MEAN|1.667||0.002|TWO_SIDED|95.0|-8.39|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.85|-8.39|0.002
71723660|NCT01942668|142963092|SUPERIORITY||Mean Difference (Final Values)|-4.64|STANDARD_ERROR_OF_MEAN|1.677||0.006|TWO_SIDED|95.0|-7.93|-1.35||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||-1.35|-7.93|0.006
71723661|NCT01942668|142963093|SUPERIORITY||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|1.849|<|0.001|TWO_SIDED|95.0|-9.91|-2.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.65|-9.91|<0.001
71723662|NCT01942668|142963093|SUPERIORITY||Mean Difference (Final Values)|-7.58|STANDARD_ERROR_OF_MEAN|1.835|<|0.001|TWO_SIDED|95.0|-11.18|-3.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.98|-11.18|<0.001
71830126|NCT03520413|143164844|EQUIVALENCE|Difference between groups at 6months|Mean Difference (Final Values)|0.19||||0.39|TWO_SIDED|95.0|-0.24|0.62|||Mixed Models Analysis|||||0.62|-0.24|0.39
71830127|NCT03520413|143164845|EQUIVALENCE|Difference between groups at 12months|Mean Difference (Final Values)|-1.16||||0.1|TWO_SIDED|95.0|-2.53|0.21|||Mixed Models Analysis|||||0.21|-2.53|0.10
71723663|NCT01942668|142963093|SUPERIORITY||Mean Difference (Final Values)|-7.43|STANDARD_ERROR_OF_MEAN|1.828|<|0.001|TWO_SIDED|95.0|-11.02|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-3.84|-11.02|<0.001
71723664|NCT01942668|142963093|SUPERIORITY||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|1.851|<|0.001|TWO_SIDED|95.0|-10.17|-2.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||-2.91|-10.17|<0.001
71723665|NCT01942668|142963094|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.049||0.225|TWO_SIDED|95.0|-0.04|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.16|-0.04|0.225
71723666|NCT01942668|142963094|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.049||0.741|TWO_SIDED|95.0|-0.08|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|||||0.11|-0.08|0.741
71723667|NCT01942668|142963094|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.049||0.414|TWO_SIDED|95.0|-0.06|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.14|-0.06|0.414
71723668|NCT01942668|142963094|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.049||0.69|TWO_SIDED|95.0|-0.11|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|||||0.08|-0.11|0.690
71723669|NCT01942668|142963095|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.045|TWO_SIDED|95.0|0.0|0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.21|0.00|0.045
71723670|NCT01942668|142963095|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.052||0.069|TWO_SIDED|95.0|-0.01|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis|||||0.20|-0.01|0.069
71723671|NCT01942668|142963095|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.052||0.126|TWO_SIDED|95.0|-0.02|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.18|-0.02|0.126
71723672|NCT01942668|142963095|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.052||0.907|TWO_SIDED|95.0|-0.1|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis|||||0.11|-0.10|0.907
71723673|NCT01942668|142963096|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.992|TWO_SIDED|95.0|-0.11|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.11|-0.11|0.992
71723674|NCT01942668|142963096|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.054||0.45|TWO_SIDED|95.0|-0.07|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis|||||0.15|-0.07|0.450
71723675|NCT01942668|142963096|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.663|TWO_SIDED|95.0|-0.13|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.08|-0.13|0.663
71723676|NCT01942668|142963096|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.309|TWO_SIDED|95.0|-0.16|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis|||||0.05|-0.16|0.309
71723677|NCT03497975|142963155|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0309|TWO_SIDED|95.0|1.07|4.13||Logistic regression model includes WI-NRS baseline score as a covariate, treatment and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||4.13|1.07|0.0309
71723678|NCT03497975|142963156|SUPERIORITY||Difference in LS Mean|-7.06|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.82|-3.3||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline ItchyQoL value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-3.30|-10.82|0.0002
71723679|NCT03497975|142963157|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0179|TWO_SIDED|95.0|1.11|3.07||Logistic regression model includes PAS (Item 5a) baseline score as a covariate, treatment as a fixed effect and the study site (with pooling) as a fixed effect.|Regression, Logistic|||||3.07|1.11|0.0179
71723680|NCT03497975|142963158|SUPERIORITY||Difference in LS Mean|-4.43|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-6.55|-2.31||Repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline PROMIS value. An unstructured covariance matrix is used.|Mixed Model for Repeated Measurements|||||-2.31|-6.55|<0.0001
71723681|NCT01257230|142963167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.051||0.0085|TWO_SIDED|95.0|0.034|0.234|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.234|0.034|0.0085
71723682|NCT01257230|142963167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.05||0.0005|TWO_SIDED|95.0|0.076|0.272|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.272|0.076|0.0005
71723683|NCT01257230|142963168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.056||0.1307|TWO_SIDED|95.0|-0.025|0.194|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.194|-0.025|0.1307
71723684|NCT01257230|142963168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.032|TWO_SIDED|95.0|0.01|0.223|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.223|0.010|0.0320
71723685|NCT01257230|142963169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.057||0.1231|TWO_SIDED|95.0|-0.024|0.2|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.200|-0.024|0.1231
71723686|NCT01257230|142963169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.056||0.195|TWO_SIDED|95.0|-0.037|0.182|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.182|-0.037|0.1950
71887913|NCT01162421|143296918|SUPERIORITY_OR_OTHER||Difference in percentage|6.7||||0.552|TWO_SIDED|95.0|-15.29|28.63|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||28.63|-15.29|0.552
71887914|NCT01162421|143296918|SUPERIORITY_OR_OTHER||Difference in percentage|-12.2||||0.281|TWO_SIDED|95.0|-34.04|9.72|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||9.72|-34.04|0.281
71887915|NCT01162421|143296918|SUPERIORITY_OR_OTHER||Difference in percentage|-14.4||||0.209|TWO_SIDED|95.0|-36.64|7.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||7.78|-36.64|0.209
71657519|NCT02504671|142831744|OTHER||Difference|21.6|||||TWO_SIDED|95.0|5.6|37.7|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.7|5.6|
71657520|NCT02504671|142831744|OTHER||Difference|18.9|||||TWO_SIDED|95.0|0.2|37.6|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||37.6|0.2|
71657521|NCT02504671|142831744|OTHER||Difference|24.3|||||TWO_SIDED|95.0|5.2|43.4|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||43.4|5.2|
71657522|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
71657523|NCT02504671|142831744|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
71657524|NCT02504671|142831744|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
71657525|NCT02504671|142831744|OTHER||Difference|40.5|||||TWO_SIDED|95.0|19.9|61.2|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||61.2|19.9|
71657526|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.9|5.2|
71657527|NCT02504671|142831744|OTHER||Difference|35.1|||||TWO_SIDED|95.0|13.8|56.5|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.5|13.8|
71657528|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|6.2|47.9|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||47.9|6.2|
71657529|NCT02504671|142831744|OTHER||Difference|54.1|||||TWO_SIDED|95.0|34.9|73.2|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.2|34.9|
71657530|NCT02504671|142831744|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.9|42.4|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.4|0.9|
71657531|NCT02504671|142831744|OTHER||Difference|51.4|||||TWO_SIDED|95.0|31.8|70.9|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|31.8|
71657532|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
71657533|NCT02504671|142831744|OTHER||Difference|56.8|||||TWO_SIDED|95.0|38.2|75.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||75.4|38.2|
71657534|NCT02504671|142831744|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.1|46.9|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.9|7.1|
71657535|NCT02504671|142831744|OTHER||Difference|54.1|||||TWO_SIDED|95.0|35.1|73.0|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.0|35.1|
71657536|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657537|NCT02504671|142831744|OTHER||Difference|75.7|||||TWO_SIDED|95.0|61.4|89.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||89.9|61.4|
71657538|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657539|NCT02504671|142831744|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
71657540|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657541|NCT02504671|142831744|OTHER||Difference|70.3|||||TWO_SIDED|95.0|55.0|85.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||85.5|55.0|
71657542|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657543|NCT02504671|142831744|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
71657544|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657545|NCT02504671|142831744|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
71657546|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657547|NCT02504671|142831744|OTHER||Difference|62.2|||||TWO_SIDED|95.0|45.9|78.4|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||78.4|45.9|
71657548|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657549|NCT02504671|142831744|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
71657550|NCT02504671|142831744|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657551|NCT02504671|142831744|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71657552|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657553|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71769529|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
71769530|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|4.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.1|-0.9|
71657554|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657555|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 1, ACR50. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657556|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71657557|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71657558|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
71657559|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657560|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657561|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657562|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
71657563|NCT02504671|142831745|OTHER||Difference|27.0|||||TWO_SIDED|95.0|9.3|44.7|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.7|9.3|
71657564|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
71657565|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71657566|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71657567|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
71657568|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 4, ACR70. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657569|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
71657570|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-11.7|27.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||27.9|-11.7|
71657571|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.9|-9.3|
71657572|NCT02504671|142831745|OTHER||Difference|-5.4|||||TWO_SIDED|95.0|-17.8|7.0|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.0|-17.8|
71657573|NCT02504671|142831745|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-16.0|10.6|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.6|-16.0|
71723687|NCT01257230|142963170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.06||0.2921|TWO_SIDED|95.0|-0.055|0.181|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.181|-0.055|0.2921
71723688|NCT01257230|142963170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.059||0.5495|TWO_SIDED|95.0|-0.08|0.15|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.150|-0.080|0.5495
71769531|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|10.3|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.3|-19.2|
71769532|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
71723689|NCT01257230|142963171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0079|TWO_SIDED|95.0|0.034|0.225|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.225|0.034|0.0079
71723690|NCT01257230|142963171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.048||0.0002|TWO_SIDED|95.0|0.088|0.275|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.275|0.088|0.0002
71723691|NCT01257230|142963172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.054||0.0945|TWO_SIDED|95.0|-0.016|0.196|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.196|-0.016|0.0945
71723692|NCT01257230|142963172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.053||0.1755|TWO_SIDED|95.0|-0.032|0.175|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.175|-0.032|0.1755
71723693|NCT01257230|142963174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.092||0.976|TWO_SIDED|95.0|-0.184|0.178|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.178|-0.184|0.9760
71723694|NCT01257230|142963174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.09||0.9224|TWO_SIDED|95.0|-0.186|0.168|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.186|0.9224
71723695|NCT01257230|142963175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.083||0.7852|TWO_SIDED|95.0|-0.14|0.185|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.185|-0.140|0.7852
71723696|NCT01257230|142963175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.081||0.1649|TWO_SIDED|95.0|-0.046|0.271|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.271|-0.046|0.1649
71723697|NCT01257230|142963176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.143||0.8253|TWO_SIDED|95.0|-0.312|0.249|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.249|-0.312|0.8253
71723698|NCT01257230|142963176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.14||0.7559|TWO_SIDED|95.0|-0.232|0.319|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.319|-0.232|0.7559
71723699|NCT01257230|142963177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.087||0.0653|TWO_SIDED|95.0|-0.33|0.01|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.010|-0.330|0.0653
71723700|NCT01257230|142963177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.084||0.2516|TWO_SIDED|95.0|-0.263|0.069|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.069|-0.263|0.2516
71723701|NCT01257230|142963179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.095||0.12|TWO_SIDED|95.0|-0.333|0.038|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.038|-0.333|0.1200
71723702|NCT01257230|142963179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.092||0.5589|TWO_SIDED|95.0|-0.235|0.127|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.127|-0.235|0.5589
71723703|NCT01257230|142963181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.4023|TWO_SIDED|95.0|0.21|1.87|||Regression, Cox|||||1.87|0.21|0.4023
71723704|NCT01257230|142963181|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.062|TWO_SIDED|95.0|0.05|1.08|||Regression, Cox|||||1.08|0.05|0.0620
71723705|NCT01257230|142963182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.87|TWO_SIDED|95.0|0.65|1.66|||Regression, Cox|||||1.66|0.65|0.8700
71723706|NCT01257230|142963182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.4198|TWO_SIDED|95.0|0.51|1.33|||Regression, Cox|||||1.33|0.51|0.4198
71723707|NCT03070171|142963199|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-tz of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.46909|||||TWO_SIDED|90.0|101.44605|115.97833|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.97833|101.44605|
71723708|NCT03070171|142963200|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.9587|||||TWO_SIDED|90.0|101.78627|116.63654|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||116.63654|101.78627|
71830128|NCT01240330|143164917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.9|STANDARD_DEVIATION|7.46|<|0.0001|TWO_SIDED|95.0|16.3|21.59|||t-test, 1 sided|||The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.||21.59|16.30|<0.0001
71830129|NCT01755949|143164920|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.038
71723709|NCT03070171|142963201|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.61507|||||TWO_SIDED|90.0|100.61938|115.09714|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.09714|100.61938|
71723710|NCT03070171|142963202|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of Cmax of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|106.69566|||||TWO_SIDED|90.0|99.50139|114.4101|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.41010|99.50139|
71723711|NCT03070171|142963203|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.83324|||||TWO_SIDED|90.0|101.25584|114.8379|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||114.83790|101.25584|
71723712|NCT03070171|142963204|EQUIVALENCE|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.43158|||||TWO_SIDED|90.0|101.87254|115.41292|||ANOVA||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'.||115.41292|101.87254|
71723713|NCT01471028|142963207|SUPERIORITY||Hazard Ratio (HR)|1.027||||0.904|TWO_SIDED|95.0|0.689|1.53|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.53|0.689|0.904
71723714|NCT01471028|142963208|SUPERIORITY|||||||0.737|||||||Chi-squared|||||||0.737
71723715|NCT01471028|142963209|SUPERIORITY||Hazard Ratio (HR)|1.315||||0.168|TWO_SIDED|95.0|0.886|1.952|||Log Rank|||||1.952|0.886|0.168
71723716|NCT01471028|142963210|SUPERIORITY||Hazard Ratio (HR)|0.283||||0.007|TWO_SIDED|95.0|0.109|0.732|||Log Rank|||||0.732|0.109|0.007
71723717|NCT04445519|142963253|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the 95.1% CIs around the difference (NCX 470 minus latanoprost 0.005%) in mean IOP reduction from time-matched baseline in the study eye was greater than or equal to -1.5 mmHg at all time points and was greater than or equal to -1.0 mmHg at a majority of the time points.|Mean Difference (Net)|1.0|STANDARD_DEVIATION|3.25|||TWO_SIDED|95.1||||The primary efficacy assessment was the non-inferiority analysis of the difference in the treatment effect between NCX 470 and latanoprost 0.005% for mean IOP reduction from time-matched baseline at the 8AM and 4PM time-points.|||The analysis assumed a true difference of 1.0 mmHg at the Week 2 time points and 1.25 mmHg at the Week 6 and Month 3 time points; a common standard deviation (SD) at each time-point of 3.25 mmHg; and a two-sided significance level of 4.9%.|||||
71723718|NCT03115827|142963266|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
71723719|NCT00177294|142963283|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Regression, Logistic|||We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.||||0.14
71723720|NCT00683930|142963293|SUPERIORITY_OR_OTHER||Treatment difference in response rate|5.1||||0.6558||97.5|-17.4|27.6|||Fisher Exact|Alpha = 0.025||||27.6|-17.4|0.6558
71723721|NCT02152371|142963304|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-0.77|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.97|-0.56|||Mixed Model for Repeated Measures (MMRM)|||||-0.56|-0.97|<.001
71723722|NCT02152371|142963305|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-16.73|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-26.02|-7.44|||Mixed Models Analysis|||||-7.44|-26.02|<.001
71723723|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-8.06|STANDARD_ERROR_OF_MEAN|2.95||0.007|TWO_SIDED|95.0|-13.87|-2.25|||Mixed Models Analysis|||Pre-Morning Meal||-2.25|-13.87|.007
71723724|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-17.18|STANDARD_ERROR_OF_MEAN|4.45|<|0.001|TWO_SIDED|95.0|-25.96|-8.4|||Mixed Models Analysis|||Morning Meal 2-Hour Postprandial||-8.40|-25.96|<.001
71723725|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-15.55|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-23.58|-7.52|||Mixed Models Analysis|||Pre-Midday Meal||-7.52|-23.58|<.001
71723726|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-18.15|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.18|-9.12|||Mixed Models Analysis|||Midday Meal 2-Hour Postprandial||-9.12|-27.18|<.001
71723727|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-14.96|STANDARD_ERROR_OF_MEAN|4.55||0.001|TWO_SIDED|95.0|-23.93|-5.99|||Mixed Models Analysis|||Pre-Evening Meal||-5.99|-23.93|.001
71723728|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-21.28|STANDARD_ERROR_OF_MEAN|5.68|<|0.001|TWO_SIDED|95.0|-32.46|-10.1|||Mixed Models Analysis|||Evening Meal 2-Hour Postprandial||-10.10|-32.46|<.001
71723729|NCT02152371|142963306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Diff|-19.48|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-28.77|-10.18|||Mixed Models Analysis|||3:00AM (Morning)||-10.18|-28.77|<.001
71723730|NCT02152371|142963307|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.19|-1.64|||Mixed Models Analysis|||||-1.64|-3.19|<.001
71657574|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
71657575|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657576|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657577|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
71657578|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
71657579|NCT02504671|142831745|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
71657580|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657581|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657582|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657583|NCT02504671|142831745|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657584|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657585|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657586|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.0|42.7|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|6.0|
71657587|NCT02504671|142831745|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
71657588|NCT02504671|142831745|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
71657589|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
71657590|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71657591|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
71657592|NCT02504671|142831745|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71657593|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71657594|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71657595|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-5.4|32.4|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.4|-5.4|
71657596|NCT02504671|142831745|OTHER||Difference|29.7|||||TWO_SIDED|95.0|9.8|49.7|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||49.7|9.8|
71657597|NCT02504671|142831745|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
71657598|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71657599|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71657600|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71657601|NCT02504671|142831745|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71723731|NCT02152371|142963308|SUPERIORITY_OR_OTHER_LEGACY||LS Means Diff|-13.19|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-19.55|-6.84|||MMRM|||||-6.84|-19.55|<.001
71723732|NCT02152371|142963315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.66|||<|0.001|TWO_SIDED|95.0|3.7|12.0|||Regression, Logistic|||||12.00|3.70|<.001
71723733|NCT02152371|142963315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|5.71|||<|0.001|TWO_SIDED|95.0|3.35|9.73|||Regression, Logistic|||||9.73|3.35|<.001
71723734|NCT02152371|142963316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.17|||<|0.001|TWO_SIDED|95.0|2.32|7.47|||Regression, Logistic|||||7.47|2.32|<.001
71723735|NCT02152371|142963317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.09|6.23|||Regression, Logistic|||||6.23|2.09|<.001
71723736|NCT02152371|142963318|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.6|||<|0.001|TWO_SIDED|95.0|3.26|9.62|||Regression, Logistic|||||9.62|3.26|<.001
71723737|NCT05352412|142963320|OTHER|Mann-Whitney U|Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
71723738|NCT05352412|142963320|OTHER|Mann-Whitney U|Mann-Whitney U|0.39||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey compared with immediate follow-up survey||||0.39
71723739|NCT05352412|142963320|OTHER|Mann-Whitney U|Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.21
71723740|NCT05352412|142963320|OTHER||Mann-Whitney U|0.19||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.19
71723741|NCT05352412|142963320|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline survey versus immediate follow-up||||0.38
71769533|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
71723742|NCT05352412|142963320|OTHER||Mann-Whitney U|0.25||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared with baseline survey||||0.25
71723743|NCT05352412|142963320|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90 days post-discharge compared with baseline survey||||0.07
71723744|NCT05352412|142963320|OTHER||Mann-Whitney U|0.03||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up between the two arms||||0.03
71723745|NCT05352412|142963320|OTHER||Mann-Whitney U|0.65||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge comparison between the 2 arms||||0.65
71723746|NCT05352412|142963320|OTHER||Mann-Whitney U|0.97||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-days post discharge compared between the 2 arms||||0.97
71723747|NCT05352412|142963321|OTHER||Mann-Whitney U|0.77||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline comparison between the 2 arms||||0.77
71723748|NCT05352412|142963321|OTHER||Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.85
71723749|NCT05352412|142963321|OTHER||Mann-Whitney U|0.38||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2-week post-discharge compared with baseline survey||||0.38
71723750|NCT05352412|142963321|OTHER||Mann-Whitney U|0.21||||0.21|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post discharge compared with baseline survey||||0.21
71723751|NCT05352412|142963321|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared with baseline survey||||0.32
71723752|NCT05352412|142963321|OTHER||Mann-Whitney U|0.09||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 week post-discharge compared with baseline survey||||0.09
71723753|NCT05352412|142963321|OTHER||Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared with baseline survey||||0.07
71723754|NCT05352412|142963321|OTHER||Mann-Whitney U|0.26||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2 weeks post-discharge compared between the 2 arms||||0.26
71723755|NCT05352412|142963321|OTHER||Mann-Whitney U|0.69||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up compared between the 2 arms||||0.69
71723756|NCT05352412|142963321|OTHER||Mann-Whitney U|0.32||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||90-day post-discharge compared between the 2 arms||||0.32
71723757|NCT05352412|142963325|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71723758|NCT05352412|142963325|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71723759|NCT05352412|142963325|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.12
71723760|NCT05352412|142963325|OTHER|Mann-Whitney U|Mann-Whitney U|0.12||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.12
71723761|NCT05352412|142963326|OTHER|Mann-Whitney U|Mann-Whitney U|0.48||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.48
71769534|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.4|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.4|
71769535|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
71769536|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.3|7.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.8|-2.3|
71723762|NCT05352412|142963326|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71723763|NCT05352412|142963326|OTHER|Mann-Whitney U|Mann-Whitney U|0.17||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
71657602|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71723764|NCT05352412|142963326|OTHER|Mann-Whitney U|Mann-Whitney U|0.42||||0.42|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.42
71723765|NCT05352412|142963327|OTHER|Mann-Whitney U|Mann-Whitney U|1.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||1.00
71723766|NCT05352412|142963327|OTHER|Mann-Whitney U|Mann-Whitney U|0.11||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.11
71723767|NCT05352412|142963327|OTHER|Mann-Whitney U|Mann-Whitney U|0.89||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up||||0.89
71723768|NCT05352412|142963327|OTHER|Mann-Whitney U|Mann-Whitney U|0.55||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up||||0.55
71657603|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71657604|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-10.1|26.3|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.3|-10.1|
71657605|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
71657606|NCT02504671|142831745|OTHER||Difference|37.8|||||TWO_SIDED|95.0|17.9|57.8|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.8|17.9|
71657607|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-10.6|16.0|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.0|-10.6|
71657608|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-0.2|32.6|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||32.6|-0.2|
71657609|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71657610|NCT02504671|142831745|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-11.7|6.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||6.3|-11.7|
71657611|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-3.1|24.7|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.7|-3.1|
71657612|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71657613|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-6.9|28.5|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.5|-6.9|
71657614|NCT02504671|142831745|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
71657615|NCT02504671|142831745|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.8|62.6|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||62.6|23.8|
71657616|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-14.1|
71657617|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
71657618|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|1.1|36.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.7|1.1|
71657619|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||10.3|-10.3|
71657620|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71657621|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||21.3|-5.1|
71657622|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657623|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657624|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657625|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71723769|NCT05352412|142963328|OTHER|Mann-Whitney U|Mann-Whitney U|0.66||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline||||0.66
71723770|NCT05352412|142963328|OTHER|Mann-Whitney U|Mann-Whitney U|0.2||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.20
71723771|NCT05352412|142963328|OTHER|Mann-Whitney U|Mann-Whitney U|0.85||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline versus immediate follow-up post randomization||||0.85
71723772|NCT05352412|142963328|OTHER|Mann-Whitney U|Mann-Whitney U|0.07||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Immediate follow-up post randomization||||0.07
71723773|NCT06359028|142963329|SUPERIORITY||Adjusted Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-2.16|-1.72|||Mixed Model with Repeated Measures|||||-1.72|-2.16|<0.0001
71723774|NCT06359028|142963330|SUPERIORITY||Adjusted Mean Difference|57.37|STANDARD_ERROR_OF_MEAN|3.599|<|0.0001|TWO_SIDED|95.0|50.23|64.51|||Mixed Model with Repeated Measures|||||64.51|50.23|<0.0001
71723775|NCT06359028|142963331|SUPERIORITY||Adjusted Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.89|-1.41|||Mixed Model with Repeated Measures|||||-1.41|-1.89|<0.0001
71723776|NCT06359028|142963332|SUPERIORITY||Adjusted Mean Difference|35.37|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|26.88|43.86|||Mixed Model with Repeated Measures|||||43.86|26.88|<0.0001
71723777|NCT06359028|142963333|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.296||0.1268|TWO_SIDED|95.0|-1.04|0.13|||Mixed Model with Repeated Measures|||Q7, Day 28||0.13|-1.04|0.1268
71723778|NCT06359028|142963333|SUPERIORITY||Adjusted Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.316|<|0.0001|TWO_SIDED|95.0|-2.38|-1.13|||Mixed Model with Repeated Measures|||Q7, Day 56||-1.13|-2.38|<0.0001
71723779|NCT06359028|142963333|SUPERIORITY||Adjusted Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.315||0.0245|TWO_SIDED|95.0|-1.35|-0.09|||Mixed Model with Repeated Measures|||Q8, Day 28||-0.09|-1.35|0.0245
71723780|NCT06359028|142963333|SUPERIORITY||Adjusted Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.318|<|0.0001|TWO_SIDED|95.0|-2.44|-1.18|||Mixed Model with Repeated Measures|||Q8, Day 56||-1.18|-2.44|<0.0001
71723781|NCT06359028|142963333|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.337||0.3851|TWO_SIDED|95.0|-0.96|0.37|||Mixed Model with Repeated Measures|||Q9, Day 28||0.37|-0.96|0.3851
71723782|NCT06359028|142963333|SUPERIORITY||Adjusted Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.375||0.0002|TWO_SIDED|95.0|-2.22|-0.73|||Mixed Model with Repeated Measures|||Q9, Day 56||-0.73|-2.22|0.0002
71723783|NCT06359028|142963334|SUPERIORITY||Adjusted Mean Difference|-6.19|STANDARD_ERROR_OF_MEAN|4.674||0.1884|TWO_SIDED|95.0|-15.46|3.08|||Mixed Model with Repeated Measures|||Day 28||3.08|-15.46|0.1884
71723784|NCT06359028|142963334|SUPERIORITY||Adjusted Mean Difference|-24.49|STANDARD_ERROR_OF_MEAN|6.308||0.0002|TWO_SIDED|95.0|-37.0|-11.97|||Mixed Model with Repeated Measures|||Day 56||-11.97|-37.00|0.0002
71723785|NCT06359028|142963335|SUPERIORITY||Adjusted Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.774||0.3003|TWO_SIDED|95.0|-2.34|0.73|||Mixed Model with Repeated Measures|||Day 28||0.73|-2.34|0.3003
71723786|NCT06359028|142963335|SUPERIORITY||Adjusted Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.903||0.0028|TWO_SIDED|95.0|-4.56|-0.97|||Mixed Model with Repeated Measures|||Day 56||-0.97|-4.56|0.0028
71723787|NCT06359028|142963336|SUPERIORITY||Adjusted Mean Difference|-3.78|STANDARD_ERROR_OF_MEAN|2.127||0.0784|TWO_SIDED|95.0|-8.0|0.44|||Mixed Model with Repeated Measures|||Day 28||0.44|-8.00|0.0784
71723788|NCT06359028|142963336|SUPERIORITY||Adjusted Mean Difference|-8.17|STANDARD_ERROR_OF_MEAN|3.074||0.0092|TWO_SIDED|95.0|-14.27|-2.07|||Mixed Model with Repeated Measures|||Day 56||-2.07|-14.27|0.0092
71723789|NCT06359028|142963337|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.846||0.8686|TWO_SIDED|95.0|-1.82|1.54|||Mixed Model with Repeated Measures|||Day 28||1.54|-1.82|0.8686
71723790|NCT06359028|142963337|SUPERIORITY||Adjusted Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.976||0.0012|TWO_SIDED|95.0|-5.18|-1.31|||Mixed Model with Repeated Measures|||Day 56||-1.31|-5.18|0.0012
71723791|NCT06359028|142963338|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|1.444||0.9047|TWO_SIDED|95.0|-3.04|2.69|||Mixed Model with Repeated Measures|||Day 28||2.69|-3.04|0.9047
71723792|NCT06359028|142963338|SUPERIORITY||Adjusted Mean Difference|-6.66|STANDARD_ERROR_OF_MEAN|1.656||0.0001|TWO_SIDED|95.0|-9.95|-3.38|||Mixed Model with Repeated Measures|||Day 56||-3.38|-9.95|0.0001
71723793|NCT06359028|142963339|SUPERIORITY||Adjusted Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.84||0.5733|TWO_SIDED|95.0|-2.14|1.19|||Mixed Model with Repeated Measures|||Day 28||1.19|-2.14|0.5733
71723794|NCT06359028|142963339|SUPERIORITY||Adjusted Mean Difference|-2.88|STANDARD_ERROR_OF_MEAN|1.026||0.006|TWO_SIDED|95.0|-4.92|-0.84|||Mixed Model with Repeated Measures|||Day 56||-0.84|-4.92|0.0060
71723795|NCT06359028|142963340|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.127||0.2768|TWO_SIDED|95.0|-0.39|0.11|||Mixed Model with Repeated Measures|||Day 28||0.11|-0.39|0.2768
71723796|NCT06359028|142963340|SUPERIORITY||Adjusted Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.113||0.0232|TWO_SIDED|95.0|-0.48|-0.04|||Mixed Model with Repeated Measures|||Day 56||-0.04|-0.48|0.0232
71723797|NCT06359028|142963341|SUPERIORITY||Adjusted Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.403||0.8996|TWO_SIDED|95.0|-0.75|0.85|||Mixed Model with Repeated Measures|||Day 28||0.85|-0.75|0.8996
71723798|NCT06359028|142963341|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.383||0.0204|TWO_SIDED|95.0|-1.66|-0.14|||Mixed Model with Repeated Measures|||Day 56||-0.14|-1.66|0.0204
71723799|NCT04382586|142963342|SUPERIORITY||Odds Ratio (OR)|1.61||||0.4099|TWO_SIDED|95.0|0.349|7.391|||Unstratified 1-sided Fisher's exact test|||||7.391|0.349|0.4099
71723800|NCT04382586|142963343|SUPERIORITY||Hazard Ratio (HR)|0.918||||0.7619|TWO_SIDED|95.0|0.511|1.648|||Log Rank|||||1.648|0.511|0.7619
71723801|NCT00107900|142963362|SUPERIORITY_OR_OTHER|||||||0.238|TWO_SIDED||||||Fisher Exact|||||||0.238
71830130|NCT01755949|143164920|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein||||0.98
71657626|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657627|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71723802|NCT03088930|142963367|OTHER||Summary statistics|0.0|||||TWO_SIDED|||||||||Three subjects enrolled. No statistical analysis completed due to low accrual.|Three subjects enrolled. No statistical analysis completed due to low accrual.|||
71723803|NCT01716039|142963379|OTHER|Comparing the change in the modified Baron score from baseline to week 18 between the treatment groups||||||0.758|||||||Wilcoxon (Mann-Whitney)|||||||0.758
71723804|NCT01716039|142963379|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71723805|NCT01716039|142963380|OTHER|||||||0.908||||||p-value for the overall treatment difference is based on an analysis of covariance adjusting for baseline UCEIS|ANCOVA|||||||0.908
71723806|NCT03215758|142963388|SUPERIORITY||Mean Difference (Net)|0.0238||||0.088|TWO_SIDED|95.0|-0.006|0.088|||ANCOVA|||||0.088|-0.006|0.088
71723807|NCT03215758|142963389|SUPERIORITY||Mean Difference (Net)|-0.06||||0.278|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.278
71723808|NCT03215758|142963390|SUPERIORITY||Mean Difference (Net)|-0.08||||0.429|TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||||0.13|-0.30|0.429
71723809|NCT03215758|142963391|SUPERIORITY||Mean Difference (Net)|0.069||||0.777|TWO_SIDED|95.0|-0.12|0.15|||ANCOVA|||||0.15|-0.12|0.777
71830131|NCT01755949|143164920|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||difference between placebo and colchicine levels at day 28||||0.072
71830132|NCT01755949|143164921|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||placebo vs colchicine||||0.08
71830133|NCT05082935|143164931|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.09|TWO_SIDED|95.0|-0.008|0.104|||ANCOVA|||||0.104|-0.008|0.09
71830134|NCT05082935|143164932|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.02|TWO_SIDED|95.0|0.02|0.29|||ANCOVA|||||0.29|0.02|0.02
71830135|NCT05082935|143164933|SUPERIORITY||Ratio of Means|-0.076||||0.03|TWO_SIDED|95.0|-0.145|-0.007|||ANCOVA|||||-0.007|-0.145|0.03
71830136|NCT05082935|143164934|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.38|TWO_SIDED|95.0|-0.04|0.09|||ANCOVA|||||0.09|-0.04|0.38
71830137|NCT05082935|143164935|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.002|TWO_SIDED|95.0|0.04|0.16|||ANCOVA|||||0.16|0.04|0.002
71887916|NCT01162421|143296918|SUPERIORITY_OR_OTHER||Difference in percentage|-19.6||||0.091|TWO_SIDED|95.0|-41.74|2.62|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||2.62|-41.74|0.091
71887917|NCT01162421|143296919|SUPERIORITY_OR_OTHER||Difference in percentage|15.6||||0.148|TWO_SIDED|95.0|-5.05|36.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||36.26|-5.05|0.148
71887918|NCT01162421|143296919|SUPERIORITY_OR_OTHER||Difference in percentage|20.7||||0.06|TWO_SIDED|95.0|-0.14|41.61|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.61|-0.14|0.060
71887919|NCT01162421|143296919|SUPERIORITY_OR_OTHER||Difference in percentage|8.7||||0.451|TWO_SIDED|95.0|-13.85|31.29|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||31.29|-13.85|0.451
71887920|NCT01162421|143296919|SUPERIORITY_OR_OTHER||Difference in percentage|9.3||||0.413|TWO_SIDED|95.0|-12.82|31.43|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||31.43|-12.82|0.413
71887921|NCT01162421|143296919|SUPERIORITY_OR_OTHER||Difference in percentage|-7.3||||0.528|TWO_SIDED|95.0|-29.74|15.23|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||15.23|-29.74|0.528
71887922|NCT01162421|143296919|SUPERIORITY_OR_OTHER||Difference in percentage|-9.5||||0.399|TWO_SIDED|95.0|-31.61|12.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||12.56|-31.61|0.399
71657628|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71723810|NCT04115748|142963392|SUPERIORITY||Difference in response rates|32.1||||0.048|TWO_SIDED|95.0|2.6|61.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio) DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||61.6|2.6|0.048
71723811|NCT04115748|142963392|SUPERIORITY||Difference in response rates|18.4||||0.23|TWO_SIDED|95.0|-12.4|49.2||The stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.2|-12.4|0.23
71830138|NCT02200770|143164945|SUPERIORITY||Hazard Ratio (HR)|0.272|||<|0.0001|TWO_SIDED|95.0|0.1496|0.4961|||Regression, Cox|||||0.4961|0.1496|<0.0001
71830139|NCT02200770|143164946|SUPERIORITY||Odds Ratio (OR)|0.352||||0.0033|TWO_SIDED|95.0|0.1755|0.7059|||Regression, Logistic|||||0.7059|0.1755|0.0033
71830140|NCT02200770|143164947|SUPERIORITY||Mean Difference (Net)|0.134|STANDARD_ERROR_OF_MEAN|1.096||0.9026|TWO_SIDED|95.0|-2.0254|2.2941|||ANCOVA|||||2.2941|-2.0254|0.9026
71830141|NCT02200770|143164948|SUPERIORITY||Rate Ratio|0.566||||0.0034|TWO_SIDED|95.0|0.3866|0.8279|||Negative Binomial Regression|||||0.8279|0.3866|0.0034
71830142|NCT02200770|143164949|SUPERIORITY||Rate Ratio|0.317||||0.0146|TWO_SIDED|95.0|0.1257|0.7972|||Negative Binomial Regression|||||0.7972|0.1257|0.0146
71830143|NCT01214824|143164962|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.014||95.0|||||Wilcoxon signed rank test|||Comparison is HbA1c at 6 months versus Baseline||||0.014
71830144|NCT01214824|143164964|SUPERIORITY_OR_OTHER|||||||0.5304||95.0|||||Paired t-test|||Comparison is masked phase 2 versus masked phase 1||||0.5304
71830145|NCT03475316|143164966|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.14|1.49|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the composite score pre and post intervention.||1.49|-1.14|
71830146|NCT03475316|143164967|SUPERIORITY||Mean Difference (Net)|166.16|STANDARD_ERROR_OF_MEAN|-202.7|||TWO_SIDED|95.0|-231.12|563.44|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Digit Symbol Substitution test at post intervention from pre intervention between the social dancing and treadmill walking group.||563.44|-231.12|
71769537|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-26.0|||||TWO_SIDED|95.0|-36.6|-15.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||-15.7|-36.6|
71769538|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||TWO_SIDED|95.0|-13.3|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-13.3|
71769539|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|21.0|||||TWO_SIDED|95.0|12.8|28.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.3|12.8|
71769540|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-18.0|||||TWO_SIDED|95.0|-32.5|-5.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-5.8|-32.5|
71769541|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|-7.0|||||TWO_SIDED|95.0|-22.3|9.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.5|-22.3|
71769542|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|20.0|||||TWO_SIDED|95.0|8.4|31.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||31.3|8.4|
71769543|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-46.0|-15.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-15.5|-46.0|
71769544|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-10.8|18.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||18.8|-10.8|
71769545|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|22.0|||||TWO_SIDED|95.0|12.1|32.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||32.8|12.1|
71769546|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-13.4|7.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.1|-13.4|
71769547|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.2|8.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.5|-3.2|
71769548|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.2|13.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.2|4.2|
71769549|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-15.1|16.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||16.1|-15.1|
71887923|NCT01162421|143296920|SUPERIORITY_OR_OTHER||Difference in percentage|12.5||||0.111|TWO_SIDED|95.0|-1.7|27.06|||Fisher Exact|||Month 3||27.06|-1.70|0.111
71887924|NCT01162421|143296920|SUPERIORITY_OR_OTHER||Difference in percentage|19.6||||0.031|TWO_SIDED|95.0|2.74|36.53||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||36.53|2.74|0.031
71769550|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.7|13.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.9|-4.7|
71769551|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|5.9|20.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||20.9|5.9|
71769552|NCT02446743|143039194|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.7|8.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||8.6|-16.7|
71769553|NCT02446743|143039194|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-5.7|11.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-5.7|
71769554|NCT02446743|143039194|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|5.0|||||TWO_SIDED|95.0|-0.7|11.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.1|-0.7|
71769555|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-30.0|||||TWO_SIDED|95.0|-40.4|-19.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-19.0|-40.4|
71769556|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.6|10.3|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.3|-2.6|
71769557|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|3.9|12.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.5|3.9|
71769558|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-27.0|||||TWO_SIDED|95.0|-41.8|-12.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-12.9|-41.8|
71769559|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-6.0|16.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.2|-6.0|
71769560|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|7.0|||||TWO_SIDED|95.0|1.4|15.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.2|1.4|
71769561|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||TWO_SIDED|95.0|-45.1|-14.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-14.6|-45.1|
71769562|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|1.9|13.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||13.5|1.9|
71887925|NCT01162421|143296920|SUPERIORITY_OR_OTHER||Difference in percentage|2.8||||0.78|TWO_SIDED|95.0|-16.74|22.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||22.31|-16.74|0.780
71887926|NCT01162421|143296920|SUPERIORITY_OR_OTHER||Difference in percentage|16.5||||0.092|TWO_SIDED|95.0|-2.07|35.04|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||35.04|-2.07|0.092
71887927|NCT01162421|143296920|SUPERIORITY_OR_OTHER||Difference in percentage|10.8||||0.29|TWO_SIDED|95.0|-8.86|30.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||30.40|-8.86|0.290
71887928|NCT01162421|143296920|SUPERIORITY_OR_OTHER||Difference in percentage|-16.9||||0.116|TWO_SIDED|95.0|-37.86|4.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||4.01|-37.86|0.116
71769563|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||TWO_SIDED|95.0|4.4|15.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.0|4.4|
71769564|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.5|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.5|-16.0|
71769565|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-0.9|6.2|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.2|-0.9|
71769566|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-0.33|5.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-0.33|
71769567|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-20.5|10.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||10.6|-20.5|
71769568|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|8.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.8|-3.6|
71769569|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-3.6|4.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.4|-3.6|
71769570|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-19.4|13.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||13.0|-19.4|
71769571|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.5|11.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.0|-2.5|
71830147|NCT03475316|143164967|SUPERIORITY||Mean Difference (Net)|24.6|STANDARD_ERROR_OF_MEAN|28.47|||TWO_SIDED|95.0|-31.2|80.4|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) and p-values are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Flanker interference test at post intervention from pre intervention between the social dancing and treadmill walking group.||80.40|-31.20|
71887929|NCT01162421|143296921|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.9|-1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 3||-1.2|-5.9|0.004
71887930|NCT01162421|143296921|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.8|-2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-2.3|-6.8|<0.001
71769572|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.2|9.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||9.4|-1.2|
71769573|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-20.0|||||TWO_SIDED|95.0|-30.0|-11.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.1|-30.0|
71769574|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||TWO_SIDED|95.0|-7.6|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-7.6|
71723812|NCT04115748|142963394|SUPERIORITY||Difference in response rates|16.1||||0.17|TWO_SIDED|95.0|-9.7|41.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|0.17
71723813|NCT04115748|142963394|SUPERIORITY||Difference in response rates|11.7||||0.27|TWO_SIDED|95.0|-13.3|36.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||36.6|-13.3|0.27
71723814|NCT04115748|142963394|SUPERIORITY||Difference in response rates|10.5||||0.42|TWO_SIDED|95.0|-20.4|41.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.5|-20.4|0.42
71723815|NCT04115748|142963394|SUPERIORITY||Difference in response rates|15.8||||0.26|TWO_SIDED|95.0|-16.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.6|-16.0|0.26
71723816|NCT04115748|142963394|SUPERIORITY||Difference in response rates|28.7||||0.062|TWO_SIDED|95.0|-5.0|62.3||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||62.3|-5.0|0.062
71723817|NCT04115748|142963394|SUPERIORITY||Difference in response rates|31.6||||0.047|TWO_SIDED|95.0|-1.5|64.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||64.6|-1.5|0.047
71723818|NCT04115748|142963394|SUPERIORITY||Difference in response rates|7.8||||0.58|TWO_SIDED|95.0|-24.6|40.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.2|-24.6|0.58
71723819|NCT04115748|142963394|SUPERIORITY||Difference in response rates|16.8||||0.27|TWO_SIDED|95.0|-16.2|49.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.9|-16.2|0.27
71723820|NCT04115748|142963395|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
71723821|NCT04115748|142963395|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
71723822|NCT04115748|142963395|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
71723823|NCT04115748|142963395|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-29.6|8.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||8.5|-29.6|
71723824|NCT04115748|142963395|SUPERIORITY||Difference in response rates|5.8|||||TWO_SIDED|95.0|-17.2|28.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.9|-17.2|
71723825|NCT04115748|142963395|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||19.5|-19.5|
71723826|NCT04115748|142963395|SUPERIORITY||Difference in response rates|5.6|||||TWO_SIDED|95.0|-10.3|21.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.4|-10.3|
71830148|NCT03475316|143164967|SUPERIORITY||Mean Difference (Net)|58.22|STANDARD_ERROR_OF_MEAN|51.2|||TWO_SIDED|95.0|-42.14|158.58|||||The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking).|Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in functional activation/deactivation covariance patterns during the Imagery of Walking-While Talking task at post intervention from pre intervention between the social dancing and treadmill walking group.||158.58|-42.14|
71723827|NCT04115748|142963395|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-8.4|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||29.5|-8.4|
71723828|NCT04115748|142963401|SUPERIORITY||Difference in response rates|16.1|||||TWO_SIDED|95.0|-9.7|41.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||41.9|-9.7|
71723829|NCT04115748|142963401|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-16.5|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||28.8|-16.5|
71887931|NCT01162421|143296921|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.16||0.021|TWO_SIDED|95.0|-5.1|-0.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.4|-5.1|0.021
71657629|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657630|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657631|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657632|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657633|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71657634|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657635|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71723830|NCT04115748|142963401|SUPERIORITY||Difference in response rates|23.9|||||TWO_SIDED|95.0|-8.8|56.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||56.6|-8.8|
71723831|NCT04115748|142963401|SUPERIORITY||Difference in response rates|27.1|||||TWO_SIDED|95.0|-5.2|59.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||59.4|-5.2|
71723832|NCT04115748|142963402|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.1|5.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.1|-5.1|
71723833|NCT04115748|142963402|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
71723834|NCT04115748|142963402|SUPERIORITY||Difference in response rates|11.7|||||TWO_SIDED|95.0|-13.3|36.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||36.6|-13.3|
71723835|NCT04115748|142963402|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-16.4|27.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.4|-16.4|
71723836|NCT04115748|142963403|SUPERIORITY||Difference in response rates|15.8||||0.2|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||45.2|-13.6|0.20
71723837|NCT04115748|142963403|SUPERIORITY||Difference in response rates|-5.0||||0.6|TWO_SIDED|95.0|-27.8|17.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.8|-27.8|0.60
71657636|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657637|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657638|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657639|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657640|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657641|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657642|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657643|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657644|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657645|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657646|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657647|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71723838|NCT04115748|142963403|SUPERIORITY||Difference in response rates|42.6||||0.008|TWO_SIDED|95.0|11.5|73.8||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||73.8|11.5|0.008
71723839|NCT04115748|142963403|SUPERIORITY||Difference in response rates|17.8||||0.17|TWO_SIDED|95.0|-12.0|47.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||47.6|-12.0|0.17
71723840|NCT04115748|142963403|SUPERIORITY||Difference in response rates|42.1||||0.011|TWO_SIDED|95.0|8.1|76.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||76.2|8.1|0.011
71723841|NCT04115748|142963403|SUPERIORITY||Difference in response rates|5.3||||0.69|TWO_SIDED|95.0|-30.1|40.6||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||40.6|-30.1|0.69
71723842|NCT04115748|142963403|SUPERIORITY||Difference in response rates|35.7||||0.033|TWO_SIDED|95.0|0.9|70.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||70.4|0.9|0.033
71723843|NCT04115748|142963403|SUPERIORITY||Difference in response rates|21.1||||0.19|TWO_SIDED|95.0|-15.2|57.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|0.19
71723844|NCT04115748|142963403|SUPERIORITY||Difference in response rates|43.9||||0.007|TWO_SIDED|95.0|12.4|75.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|0.007
71723845|NCT04115748|142963403|SUPERIORITY||Difference in response rates|7.6||||0.63|TWO_SIDED|95.0|-28.8|44.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.1|-28.8|0.63
71723846|NCT04115748|142963404|SUPERIORITY||Difference in response rates|0.0||||0.98|TWO_SIDED|95.0|-19.5|19.5||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|0.98
71769575|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|32.0|||||TWO_SIDED|95.0|23.2|40.2|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||40.2|23.2|
71769576|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-13.0|||||TWO_SIDED|95.0|-25.9|-3.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-3.0|-25.9|
71769577|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-17.1|15.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.9|-17.1|
71830149|NCT03475316|143164968|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.1|6.64|||||The Estimation Parameter is the difference in change at post from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the CHAMPS scores pre and post intervention.||6.64|-5.10|
71830150|NCT03475316|143164969|SUPERIORITY||Mean Difference (Final Values)|7.27|STANDARD_ERROR_OF_MEAN|8.57|||TWO_SIDED|95.0|-11.6|26.14|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in gait speed pre and post intervention.||26.14|-11.60|
71723847|NCT04115748|142963404|SUPERIORITY||Difference in response rates|-5.3||||0.5|TWO_SIDED|95.0|-20.7|10.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|0.50
71723848|NCT04115748|142963404|SUPERIORITY||Difference in response rates|5.5||||0.54|TWO_SIDED|95.0|-16.4|27.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||27.4|-16.4|0.54
71769578|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|20.5|45.3|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||45.3|20.5|
71769579|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-25.0|||||TWO_SIDED|95.0|-40.1|-11.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||-11.2|-40.1|
71769580|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|12.0|||||TWO_SIDED|95.0|-3.9|28.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||28.1|-3.9|
71769581|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||TWO_SIDED|95.0|22.0|44.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||44.1|22.0|
71830151|NCT03475316|143164970|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-13.4|14.55|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in unipedal stance time pre and post intervention.||14.55|-13.40|
71830152|NCT03475316|143164972|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|-1.3|3.46|||||The estimate parameter is the difference in change at post intervention from pre between dance and treadmill group.|Linear mixed effects model were used to compare changes in the geriatric depression scale pre and post intervention.||3.46|-1.30|
71830153|NCT03505099|143165100|SUPERIORITY||Difference of Proportion|76.5|||<|0.0001|TWO_SIDED|95.0|50.95|92.21|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 19 out of 81 participants (23.46%) with 3 copies of SMN2 achieved standing alone for at least 3 seconds.|92.21|50.95|<0.0001
71830154|NCT03505099|143165101|SUPERIORITY||Difference of Proportion|73.9|||<|0.0001|TWO_SIDED|95.0|44.67|91.61|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 participants (26.09%) with 2 copies of SMN2 were alive and did not require permanent ventilation.|91.61|44.67|<0.0001
71830155|NCT03505099|143165103|SUPERIORITY||Difference of Proportion|72.3|||<|0.0001|TWO_SIDED|95.0|44.9|90.11|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al, 2014 - PubMed 25080519) where 17 out of 81 participants (20.99%) with 3 copies of SMN2 achieved the ability to walk alone.|90.11|44.90|<0.0001
71830156|NCT04090190|143165117|SUPERIORITY|||||||0.6497|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the CRP Calc. Conc. (pg/ml) between baseline and follow-up.||||0.6497
71830157|NCT04090190|143165117|SUPERIORITY|||||||0.4281|||||||Wilcoxon (Mann-Whitney)|||T-test of Wilcoxon rank sum was used to test this non-normal data. Null hypothesis is that the concentration of urine inflammatory markers is the same at baseline and follow-up. This p-value is the probability that the difference in the IL-12/IL-23p40 Calc. Conc. (pg/ml) between baseline and follow-up.||||0.4281
71830158|NCT04090190|143165117|SUPERIORITY|||||||0.3157|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of MCP-1 Calc. Conc. (pg/ml) is due to chance.||||0.3157
71830159|NCT04090190|143165117|SUPERIORITY|||||||0.1463|||||||Wilcoxon (Mann-Whitney)|||This p-value represents the probability that the difference between baseline and follow-up levels of GM-CSF Calc. Conc. (pg/ml) is due to chance.||||0.1463
71769582|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B\_0\_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-16.0|6.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.0|-16.0|
71769583|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B\_0\_1 (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-6.8|8.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||8.9|-6.8|
71830160|NCT04090190|143165117|SUPERIORITY|||||||0.6091|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-1β Calc. Conc. (pg/ml) is due to chance.||||0.6091
71769584|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B\_0\_1 (1 month after booster or 2nd dose)|vaccine group difference|11.0|||||TWO_SIDED|95.0|5.3|16.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||16.9|5.3|
71769585|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72\_41) vs Day 34 Group B\_0\_1 (V72\_41) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||TWO_SIDED|95.0|-18.0|14.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||14.1|-18.0|
71769586|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72\_41) vs Day 38 Group B\_0\_1 (V72\_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||TWO_SIDED|95.0|-9.7|15.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||15.7|-9.7|
71769587|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|vaccine group difference|17.0|||||TWO_SIDED|95.0|8.2|27.8|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||27.8|8.2|
71769588|NCT02446743|143039195|OTHER|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B\_0\_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.1|9.1|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||9.1|-19.1|
71769589|NCT02446743|143039195|OTHER|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B\_0\_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|11.8|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||11.8|-8.4|
71830161|NCT04090190|143165117|SUPERIORITY|||||||0.3011|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-6 Calc. Conc. (pg/ml) is due to chance.||||0.3011
71769590|NCT02446743|143039195|OTHER|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||TWO_SIDED|95.0|-0.47|12.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||12.6|-0.47|
71769591|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|3.49|||||TWO_SIDED|95.0|2.85|4.29|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||4.29|2.85|
71830162|NCT04090190|143165117|SUPERIORITY|||||||0.5009|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the baseline and follow-up levels of the urine inflammatory markers are due to chance. This p-value represents the probability that the difference between the baseline and follow-up levels of IL-8 Calc. Conc. (pg/ml) is due to chance.||||0.5009
71830163|NCT00457691|143165120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.095||||0.8072|TWO_SIDED|95.0|0.892|1.344||p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.344|0.892|0.8072
71830164|NCT00457691|143165121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.9163|TWO_SIDED|95.0|0.936|1.466||p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank|||||1.466|0.936|0.9163
71830165|NCT00688519|143165129|SUPERIORITY_OR_OTHER|||||||0.058|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.058
71723849|NCT04115748|142963404|SUPERIORITY||Difference in response rates|0.6||||0.92|TWO_SIDED|95.0|-19.0|20.1||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|0.92
71723850|NCT04115748|142963404|SUPERIORITY||Difference in response rates|21.1||||0.13|TWO_SIDED|95.0|-9.3|51.4||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.4|-9.3|0.13
71723851|NCT04115748|142963404|SUPERIORITY||Difference in response rates|15.8||||0.22|TWO_SIDED|95.0|-13.6|45.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.2|-13.6|0.22
71723852|NCT04115748|142963404|SUPERIORITY||Difference in response rates|45.0||||0.007|TWO_SIDED|95.0|12.8|77.2||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.2|12.8|0.007
71723853|NCT04115748|142963404|SUPERIORITY||Difference in response rates|31.6||||0.039|TWO_SIDED|95.0|0.2|63.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||63.0|0.2|0.039
71723854|NCT04115748|142963404|SUPERIORITY||Difference in response rates|12.8||||0.34|TWO_SIDED|95.0|-18.4|44.0||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||44.0|-18.4|0.34
71723855|NCT04115748|142963404|SUPERIORITY||Difference in response rates|32.4||||0.04|TWO_SIDED|95.0|-0.1|64.9||P-value was calculated by logistic regression with treatment group and stratification factors (geographic region and concurrent use of csDMARDs and/or apremilast at randomization) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||64.9|-0.1|0.040
71723856|NCT04115748|142963405|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-10.0|20.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||20.6|-10.0|
71723857|NCT04115748|142963405|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.4|5.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.4|-5.4|
71723858|NCT04115748|142963405|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-9.9|20.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.4|-9.9|
71723859|NCT04115748|142963405|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||5.3|-5.3|
71723860|NCT04115748|142963405|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-14.0|35.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-14.0|
71723861|NCT04115748|142963405|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-17.1|27.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||27.6|-17.1|
71723862|NCT04115748|142963405|SUPERIORITY||Difference in response rates|27.8|||||TWO_SIDED|95.0|1.7|53.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||53.9|1.7|
71723863|NCT04115748|142963405|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|1.3|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||51.4|1.3|
71723864|NCT04115748|142963405|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-16.3|40.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.8|-16.3|
71723865|NCT04115748|142963405|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-8.2|51.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||51.4|-8.2|
71723866|NCT04115748|142963413|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-46.3|25.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||25.2|-46.3|
71657648|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71723867|NCT04115748|142963413|SUPERIORITY||Difference in response rates|-8.8|||||TWO_SIDED|95.0|-45.3|27.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||27.7|-45.3|
71723868|NCT04115748|142963413|SUPERIORITY||Difference in response rates|11.8|||||TWO_SIDED|95.0|-22.1|45.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||45.8|-22.1|
71723869|NCT04115748|142963413|SUPERIORITY||Difference in response rates|19.4|||||TWO_SIDED|95.0|-15.6|54.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.5|-15.6|
71723870|NCT04115748|142963413|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
71723871|NCT04115748|142963413|SUPERIORITY||Difference in response rates|10.5|||||TWO_SIDED|95.0|-26.0|47.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||47.0|-26.0|
71657649|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71723872|NCT04115748|142963413|SUPERIORITY||Difference in response rates|29.8|||||TWO_SIDED|95.0|-6.3|66.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||66.0|-6.3|
71723873|NCT04115748|142963413|SUPERIORITY||Difference in response rates|31.6|||||TWO_SIDED|95.0|-3.8|67.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||67.0|-3.8|
71769592|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.73|||||TWO_SIDED|95.0|2.02|3.69|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.69|2.02|
71769593|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|4.46|||||TWO_SIDED|95.0|3.38|5.88|||ANOVA|||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||5.88|3.38|
71769594|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|8.18|||||TWO_SIDED|95.0|6.51|10.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||10|6.51|
71769595|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|9.58|||||TWO_SIDED|95.0|7.17|13.0|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||13|7.17|
71769596|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|6.9|||||TWO_SIDED|95.0|4.82|9.87|||ANOVA|||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||9.87|4.82|
71769597|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|2.58|||||TWO_SIDED|95.0|1.98|3.36|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||3.36|1.98|
71769598|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.65|||||TWO_SIDED|95.0|1.89|3.73|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.73|1.89|
71769599|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|2.51|||||TWO_SIDED|95.0|1.67|3.78|||ANOVA|||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||3.78|1.67|
71769600|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B\_0\_1(1 month after booster or 2nd dose)|Ratio of GMTs|1.9|||||TWO_SIDED|95.0|1.52|2.36|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country||2.36|1.52|
71769601|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72\_41) vs Day 61 Group B\_0\_1 (V72\_41) (1 month after booster or 2nd dose)|Ratio of GMTs|1.88|||||TWO_SIDED|95.0|1.37|2.59|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.59|1.37|
71657650|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657651|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|4.7|33.2|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.2|4.7|
71723874|NCT04115748|142963413|SUPERIORITY||Difference in response rates|5.0|||||TWO_SIDED|95.0|-32.0|42.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.0|-32.0|
71723875|NCT04115748|142963413|SUPERIORITY||Difference in response rates|39.2|||||TWO_SIDED|95.0|6.8|71.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.6|6.8|
71769602|NCT02446743|143039196|OTHER|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B\_0\_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.41|2.58|||ANOVA|||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.||2.58|1.41|
71723876|NCT04115748|142963414|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||24.8|-24.8|
71723877|NCT04115748|142963414|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-24.9|26.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.0|-24.9|
71723878|NCT04115748|142963414|SUPERIORITY||Difference in response rates|-4.5|||||TWO_SIDED|95.0|-30.5|21.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||21.5|-30.5|
71723879|NCT04115748|142963414|SUPERIORITY||Difference in response rates|12.8|||||TWO_SIDED|95.0|-18.4|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.0|-18.4|
71723880|NCT04115748|142963414|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.1|56.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||56.3|-14.1|
71723881|NCT04115748|142963414|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-33.3|33.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||33.3|-33.3|
71723882|NCT04115748|142963414|SUPERIORITY||Difference in response rates|34.5|||||TWO_SIDED|95.0|-0.3|69.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||69.3|-0.3|
71723883|NCT04115748|142963414|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||55.1|-13.0|
71723884|NCT04115748|142963414|SUPERIORITY||Difference in response rates|24.4|||||TWO_SIDED|95.0|-9.7|58.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.6|-9.7|
71723885|NCT04115748|142963414|SUPERIORITY||Difference in response rates|32.6|||||TWO_SIDED|95.0|-1.0|66.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||66.2|-1.0|
71830166|NCT00688519|143165129|SUPERIORITY_OR_OTHER|||||||0.313|||||||Breslow-Day Test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.313
71723886|NCT04115748|142963416|SUPERIORITY||Difference in response rates|-15.8|||||TWO_SIDED|95.0|-47.6|16.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||16.0|-47.6|
71723887|NCT04115748|142963416|SUPERIORITY||Difference in response rates|-20.5|||||TWO_SIDED|95.0|-51.3|10.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.4|-51.3|
71723888|NCT04115748|142963416|SUPERIORITY||Difference in response rates|6.6|||||TWO_SIDED|95.0|-26.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.9|-26.8|
71723889|NCT04115748|142963416|SUPERIORITY||Difference in response rates|13.9|||||TWO_SIDED|95.0|-20.8|48.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||48.6|-20.8|
71723890|NCT04115748|142963416|SUPERIORITY||Difference in response rates|15.8|||||TWO_SIDED|95.0|-20.7|52.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||52.3|-20.7|
71723891|NCT04115748|142963416|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-31.0|41.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||41.6|-31.0|
71723892|NCT04115748|142963416|SUPERIORITY||Difference in response rates|24.3|||||TWO_SIDED|95.0|-12.4|60.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.9|-12.4|
71723893|NCT04115748|142963416|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-15.2|57.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.4|-15.2|
71830167|NCT00688519|143165130|SUPERIORITY_OR_OTHER|||||||0.029|||||||Cochran-Mantel-Haenszel|||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.029
71723894|NCT04115748|142963416|SUPERIORITY||Difference in response rates|4.4|||||TWO_SIDED|95.0|-32.3|41.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||41.2|-32.3|
71723895|NCT04115748|142963416|SUPERIORITY||Difference in response rates|23.2|||||TWO_SIDED|95.0|-12.5|58.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||58.8|-12.5|
71723896|NCT04115748|142963417|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-19.5|19.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.5|-19.5|
71723897|NCT04115748|142963417|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-20.7|10.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||10.2|-20.7|
71723898|NCT04115748|142963417|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-18.7|19.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.3|-18.7|
71723899|NCT04115748|142963417|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-19.0|20.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||20.1|-19.0|
71723900|NCT04115748|142963417|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.8|24.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.8|-24.8|
71830168|NCT00688519|143165131|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.013
71769603|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-7.5|1.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||1.8|-7.5|
71769604|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|53.0|||||TWO_SIDED|95.0|42.1|62.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||62.5|42.1|
71769605|NCT02446743|143039198|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|58.0|||||TWO_SIDED|95.0|50.5|64.7|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||64.7|50.5|
71769606|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|-4.0|||||TWO_SIDED|95.0|-14.1|2.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||2.0|-14.1|
71769607|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|28.1|58.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.5|28.1|
71769608|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|44.0|||||TWO_SIDED|95.0|32.7|54.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.1|32.7|
71769609|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|4.8|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||4.8|-8.0|
71830169|NCT00688519|143165132|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.008
71830170|NCT00688519|143165133|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.||||0.018
71657652|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71769610|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|60.0|||||TWO_SIDED|95.0|45.0|71.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||71.5|45.0|
71769611|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|71.0|||||TWO_SIDED|95.0|61.2|78.5|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||78.5|61.2|
71887932|NCT01162421|143296921|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.96||0.037|TWO_SIDED|95.0|-4.0|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.1|-4.0|0.037
71769612|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|-1.0|||||TWO_SIDED|95.0|-9.1|4.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||4|-9.1|
71769613|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|37.0|||||TWO_SIDED|95.0|27.0|48.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||48.1|27.0|
71830171|NCT00688519|143165134|SUPERIORITY_OR_OTHER|||||||0.167|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.167
71830172|NCT00688519|143165134|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.009
71769614|NCT02446743|143039198|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|33.0|||||TWO_SIDED|95.0|25.2|40.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||40.4|25.2|
71769615|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|2.0|||||TWO_SIDED|95.0|-8.7|10.2|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||10.2|-8.7|
71887933|NCT01162421|143296921|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.58||0.702|TWO_SIDED|95.0|-3.7|2.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.5|-3.7|0.702
71887934|NCT01162421|143296921|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.15||0.644|TWO_SIDED|95.0|-2.8|1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.8|-2.8|0.644
71723901|NCT04115748|142963417|SUPERIORITY||Difference in response rates|-5.3|||||TWO_SIDED|95.0|-27.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||17.1|-27.6|
71723902|NCT04115748|142963417|SUPERIORITY||Difference in response rates|17.0|||||TWO_SIDED|95.0|-10.1|44.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||44.0|-10.1|
71723903|NCT04115748|142963417|SUPERIORITY||Difference in response rates|26.3|||||TWO_SIDED|95.0|-2.1|54.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.8|-2.1|
71723904|NCT04115748|142963417|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-20.3|33.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.6|-20.3|
71723905|NCT04115748|142963417|SUPERIORITY||Difference in response rates|11.1|||||TWO_SIDED|95.0|-16.6|38.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.7|-16.6|
71723906|NCT04115748|142963419|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-34.8|34.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||34.8|-34.8|
71723907|NCT04115748|142963419|SUPERIORITY||Difference in response rates|-14.9|||||TWO_SIDED|95.0|-47.4|17.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||17.6|-47.4|
71769616|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|43.0|||||TWO_SIDED|95.0|27.7|58.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||58.6|27.7|
71769617|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|42.0|||||TWO_SIDED|95.0|31.1|53.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||53.0|31.1|
71887935|NCT01162421|143296922|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.89||0.039|TWO_SIDED|95.0|-3.7|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-0.1|-3.7|0.039
71723908|NCT04115748|142963419|SUPERIORITY||Difference in response rates|27.9|||||TWO_SIDED|95.0|-7.2|63.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||63.0|-7.2|
71723909|NCT04115748|142963419|SUPERIORITY||Difference in response rates|8.9|||||TWO_SIDED|95.0|-26.6|44.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||44.3|-26.6|
71723910|NCT04115748|142963419|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-13.0|55.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||55.1|-13.0|
71723911|NCT04115748|142963419|SUPERIORITY||Difference in response rates|-10.5|||||TWO_SIDED|95.0|-47.4|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.3|-47.4|
71723912|NCT04115748|142963419|SUPERIORITY||Difference in response rates|24.9|||||TWO_SIDED|95.0|-11.1|60.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||60.8|-11.1|
71723913|NCT04115748|142963419|SUPERIORITY||Difference in response rates|21.1|||||TWO_SIDED|95.0|-14.9|57.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||57.0|-14.9|
71723914|NCT04115748|142963419|SUPERIORITY||Difference in response rates|43.9|||||TWO_SIDED|95.0|12.4|75.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||75.4|12.4|
71723915|NCT04115748|142963419|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-23.4|49.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||49.1|-23.4|
71723916|NCT04115748|142963421|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-14.8|89.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||89.8|-14.8|
71723917|NCT04115748|142963421|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||100.0|-25.4|
71723918|NCT04115748|142963421|SUPERIORITY||Difference in response rates|-25.0|||||TWO_SIDED|95.0|-100.0|51.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||51.2|-100.0|
71723919|NCT04115748|142963421|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||77.7|-97.7|
71723920|NCT04115748|142963421|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-73.7|88.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||88.0|-73.7|
71723921|NCT04115748|142963421|SUPERIORITY||Difference in response rates|-10.0|||||TWO_SIDED|95.0|-97.7|77.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.7|-97.7|
71723922|NCT04115748|142963421|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
71723923|NCT04115748|142963421|SUPERIORITY||Difference in response rates|15.0|||||TWO_SIDED|95.0|-67.9|97.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||97.9|-67.9|
71723924|NCT04115748|142963422|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||54.2|-29.2|
71723925|NCT04115748|142963422|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||77.6|-37.6|
71723926|NCT04115748|142963422|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||73.8|-23.8|
71769618|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|-6.0|||||TWO_SIDED|95.0|-19.2|0.9|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||0.9|-19.2|
71769619|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|32.0|||||TWO_SIDED|95.0|18.2|47.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|18.2|
71830173|NCT02079844|143165150|SUPERIORITY_OR_OTHER||LS Mean Difference|0.232|STANDARD_ERROR_OF_MEAN|0.7313||0.753|TWO_SIDED|95.0|-1.269|1.733||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.733|-1.269|0.753
71723927|NCT04115748|142963422|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||100.0|-25.4|
71723928|NCT04115748|142963422|SUPERIORITY||Difference in response rates|42.9|||||TWO_SIDED|95.0|-13.4|99.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||99.2|-13.4|
71723929|NCT04115748|142963422|SUPERIORITY||Difference in response rates|40.0|||||TWO_SIDED|95.0|-25.4|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||100.0|-25.4|
71723930|NCT04115748|142963422|SUPERIORITY||Difference in response rates|37.5|||||TWO_SIDED|95.0|-35.3|100.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||100.0|-35.3|
71723931|NCT04115748|142963422|SUPERIORITY||Difference in response rates|-5.0|||||TWO_SIDED|95.0|-82.5|72.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||72.5|-82.5|
71723932|NCT04115748|142963423|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
71723933|NCT04115748|142963423|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
71723934|NCT04115748|142963423|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||54.2|-29.2|
71723935|NCT04115748|142963423|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
71723936|NCT04115748|142963423|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
71723937|NCT04115748|142963423|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||77.6|-37.6|
71723938|NCT04115748|142963423|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-23.8|73.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||73.8|-23.8|
71723939|NCT04115748|142963423|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
71723940|NCT04115748|142963424|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||18.8|-18.8|
71723941|NCT04115748|142963424|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.5|-22.5|
71723942|NCT04115748|142963424|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-18.8|18.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.8|-18.8|
71723943|NCT04115748|142963424|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.5|-22.5|
71723944|NCT04115748|142963424|SUPERIORITY||Difference in response rates|14.3|||||TWO_SIDED|95.0|-31.3|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-31.3|
71723945|NCT04115748|142963424|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.5|22.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||22.5|-22.5|
71723946|NCT04115748|142963424|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-29.2|54.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||54.2|-29.2|
71723947|NCT04115748|142963424|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-37.6|77.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||77.6|-37.6|
71723948|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.104||0.94|TWO_SIDED|95.0|-0.22|0.2||P-value was calculated from mixed-effects model for repeated measures (MMRM) including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.20|-0.22|0.94
71723949|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|0.03|STANDARD_ERROR_OF_MEAN|0.105||0.81|TWO_SIDED|95.0|-0.18|0.24||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 2||0.24|-0.18|0.81
71723950|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.112||0.13|TWO_SIDED|95.0|-0.39|0.05||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.05|-0.39|0.13
71723951|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.113||0.073|TWO_SIDED|95.0|-0.43|0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||0.02|-0.43|0.073
71723952|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.124||0.083|TWO_SIDED|95.0|-0.46|0.03||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.03|-0.46|0.083
71723953|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.124||0.28|TWO_SIDED|95.0|-0.38|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 8||0.11|-0.38|0.28
71723954|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.13||0.038|TWO_SIDED|95.0|-0.54|-0.02||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||-0.02|-0.54|0.038
71723955|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.25|TWO_SIDED|95.0|-0.41|0.11||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 12||0.11|-0.41|0.25
71723956|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.41|TWO_SIDED|95.0|-0.39|0.16||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.16|-0.39|0.41
71723957|NCT04115748|142963428|SUPERIORITY||LS Mean Treatment Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.26|TWO_SIDED|95.0|-0.43|0.12||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||0.12|-0.43|0.26
71723958|NCT04115748|142963429|SUPERIORITY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|2.26||0.14|TWO_SIDED|95.0|-1.1|7.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.9|-1.1|0.14
71723959|NCT04115748|142963429|SUPERIORITY||LS Mean Treatment Difference|3.1|STANDARD_ERROR_OF_MEAN|2.3||0.18|TWO_SIDED|95.0|-1.5|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||7.7|-1.5|0.18
71723960|NCT04115748|142963429|SUPERIORITY||LS Mean Treatment Difference|3.7|STANDARD_ERROR_OF_MEAN|2.53||0.15|TWO_SIDED|95.0|-1.4|8.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.7|-1.4|0.15
71723961|NCT04115748|142963429|SUPERIORITY||LS Mean Treatment Difference|4.8|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.3|9.9||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||9.9|-0.3|0.062
71723962|NCT04115748|142963431|SUPERIORITY||LS Mean Treatment Difference|5.3|STANDARD_ERROR_OF_MEAN|1.68||0.003|TWO_SIDED|95.0|1.9|8.6||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.6|1.9|0.003
71830174|NCT02079844|143165150|SUPERIORITY_OR_OTHER||LS Mean Difference|0.133|STANDARD_ERROR_OF_MEAN|0.7417||0.859|TWO_SIDED|95.0|-1.389|1.655||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||1.655|-1.389|0.859
71887936|NCT01162421|143296922|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-5.0|-1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.8|-5.0|<0.001
71723963|NCT04115748|142963431|SUPERIORITY||LS Mean Treatment Difference|4.9|STANDARD_ERROR_OF_MEAN|1.71||0.006|TWO_SIDED|95.0|1.5|8.3||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 4||8.3|1.5|0.006
71723964|NCT04115748|142963431|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|2.09||0.076|TWO_SIDED|95.0|-0.4|8.0||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||8.0|-0.4|0.076
71723965|NCT04115748|142963431|SUPERIORITY||LS Mean Treatment Difference|3.5|STANDARD_ERROR_OF_MEAN|2.1||0.1|TWO_SIDED|95.0|-0.7|7.7||P-value was calculated from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, and participants being the random effect.|MMRM|||Week 16||7.7|-0.7|0.10
71723966|NCT01200407|142963442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-35.8||||0|TWO_SIDED|95.0|-37.2|-34.4|||t-test, 2 sided|||SBP with LOCF (Week 12)||-34.4|-37.2|0.000
71723967|NCT01200407|142963442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.4||||0|TWO_SIDED|95.0|-20.3|-18.6|||t-test, 2 sided|||DBP with LOCF (Week 12)||-18.6|-20.3|0.000
71723968|NCT01200407|142963443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-24.7||||0|TWO_SIDED|95.0|-26.1|-23.4|||t-test, 2 sided|||SBP w/o LOCF (Week 4)||-23.4|-26.1|0.000
71723969|NCT01200407|142963443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-33.0||||0|TWO_SIDED|95.0|-34.4|-31.6|||t-test, 2 sided|||SBP w/o LOCF (Week 8)||-31.6|-34.4|0.000
71723970|NCT01200407|142963443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-36.3||||0|TWO_SIDED|95.0|-37.9|-34.7|||t-test, 2 sided|||SBP w/o LOCF (Week 12)||-34.7|-37.9|0.000
71723971|NCT01200407|142963443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.2||||0|TWO_SIDED|95.0|-14.0|-12.4|||t-test, 2 sided|||DBP w/o LOCF (Week 4)||-12.4|-14.0|0.000
71723972|NCT01200407|142963443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-17.6||||0|TWO_SIDED|95.0|-18.4|-16.7|||t-test, 2 sided|||DBP w/o LOCF (Week 8)||-16.7|-18.4|0.000
71830175|NCT02079844|143165151|SUPERIORITY_OR_OTHER||LS Mean Difference|1.938|STANDARD_ERROR_OF_MEAN|1.2436||0.131|TWO_SIDED|95.0|-0.614|4.49||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.490|-0.614|0.131
71830176|NCT02079844|143165151|SUPERIORITY_OR_OTHER||LS Mean Difference|2.377|STANDARD_ERROR_OF_MEAN|1.2545||0.069|TWO_SIDED|95.0|-0.198|4.951||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||4.951|-0.198|0.069
71887937|NCT01162421|143296922|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.008|TWO_SIDED|95.0|-3.8|-0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 9||-0.6|-3.8|0.008
71723973|NCT01200407|142963443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-19.9||||0|TWO_SIDED|95.0|-20.8|-18.9|||t-test, 2 sided|||DBP w/o LOCF (Week 12)||-18.9|-20.8|0.000
71723974|NCT00473668|142963476|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|-1.18|||||TWO_SIDED|95.0|-6.39|2.84||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||2.84|-6.39|
71723975|NCT00473668|142963476|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (\<) 10%.|Difference in anti-PRP SPR rate|0.0|||||TWO_SIDED|95.0|-4.16|3.99||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.||3.99|-4.16|
71723976|NCT03458910|142963502|SUPERIORITY|||||||0.782|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.782
71723977|NCT03458910|142963503|SUPERIORITY|||||||0.48|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.480
71723978|NCT03458910|142963504|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.410
71723979|NCT03458910|142963505|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.480
71723980|NCT03458910|142963506|SUPERIORITY|||||||0.17|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for younger adults||||0.170
71723981|NCT03458910|142963507|SUPERIORITY|||||||0.478|||||||ANOVA|||time x condition x regulation goal interaction in behavioral emotional intensity rating for older adults||||0.478
71723982|NCT03458910|142963508|SUPERIORITY|||||||0.441|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for younger adults||||0.441
71723983|NCT03458910|142963509|SUPERIORITY|||||||0.621|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the left amygdala for older adults||||0.621
71830177|NCT02079844|143165152|SUPERIORITY_OR_OTHER||LS Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.1757||0.671|TWO_SIDED|95.0|-0.739|0.106||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.106|-0.739|0.671
71723984|NCT03458910|142963510|SUPERIORITY|||||||0.19|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for younger adults||||0.190
71769620|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|24.0|||||TWO_SIDED|95.0|13.2|34.4|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||34.4|13.2|
71723985|NCT03458910|142963511|SUPERIORITY|||||||0.864|||||||ANOVA|||time x condition x regulation goal (2 x 2 x 3) interaction effect in the right amygdala activity for older adults||||0.864
71723986|NCT03458910|142963512|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of fair offers||||1.000
71723987|NCT03458910|142963512|SUPERIORITY|||||||0.716|||||||Wilcoxon (Mann-Whitney)|||Comparing acceptance rate of unfair offers||||0.716
71723988|NCT03458910|142963513|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for dorsal anterior cingulate cortex activation.||||0.014
71723989|NCT03458910|142963513|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups for anterior insula activation.||||0.059
71723990|NCT03458910|142963514|SUPERIORITY|||||||0.144|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.144
71723991|NCT03458910|142963514|SUPERIORITY|||||||0.653||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|||||||0.653
71723992|NCT03458910|142963515|SUPERIORITY|||||||0.288|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||.288
71723993|NCT03458910|142963515|SUPERIORITY|||||||0.191||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.191
71723994|NCT03458910|142963516|SUPERIORITY|||||||0.894|||||||ANOVA|||||||0.894
71723995|NCT03458910|142963516|SUPERIORITY|||||||0.425||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.425
71723996|NCT03458910|142963517|SUPERIORITY|||||||0.916|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.916
71723997|NCT03458910|142963517|SUPERIORITY|||||||0.235||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.235
71723998|NCT03458910|142963518|SUPERIORITY|||||||0.462|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.462
71723999|NCT03458910|142963518|SUPERIORITY|||||||0.468||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.468
71830178|NCT02079844|143165152|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.171|STANDARD_ERROR_OF_MEAN|0.1757||0.345|TWO_SIDED|95.0|-1.193|0.571||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA|||||0.571|-1.193|0.345
71724000|NCT03458910|142963519|SUPERIORITY|||||||0.481|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.481
71724001|NCT03458910|142963519|SUPERIORITY|||||||0.159||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.159
71724002|NCT03458910|142963520|SUPERIORITY|||||||0.602|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.602
71724003|NCT03458910|142963520|SUPERIORITY|||||||0.562||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.562
71724004|NCT03458910|142963521|SUPERIORITY|||||||0.697|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.697
71724005|NCT03458910|142963521|SUPERIORITY|||||||0.901||||||Linear mixed effects model with random factors (intercepts) for participants; F- and p-values determined using Satterthwaite's method|Mixed Models Analysis|p-value reflects effect of interest, a time x condition interaction on scores||||||0.901
71724006|NCT03458910|142963522|SUPERIORITY|||||||0.516|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.516
71887938|NCT01162421|143296922|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.71||0.028|TWO_SIDED|95.0|-3.0|-0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12||-0.2|-3.0|0.028
71724007|NCT03458910|142963523|SUPERIORITY|||||||0.944|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.944
71724008|NCT03458910|142963524|SUPERIORITY|||||||0.285|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.285
71724009|NCT03458910|142963525|SUPERIORITY|||||||0.807|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.807
71724010|NCT03458910|142963526|SUPERIORITY||||||<|0.001|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||<0.001
71724011|NCT03458910|142963527|SUPERIORITY|||||||0.74|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction||||||0.740
71724012|NCT03458910|142963528|SUPERIORITY|||||||0.083|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.083
71724013|NCT03458910|142963529|SUPERIORITY|||||||0.176|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.176
71724014|NCT03458910|142963530|SUPERIORITY|||||||0.325|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.325
71769621|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.7|3.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||3.4|-4.7|
71769622|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|Vaccine group difference|36.0|||||TWO_SIDED|95.0|25.6|45.7|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||45.7|25.6|
71887939|NCT01162421|143296922|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.94||0.452|TWO_SIDED|95.0|-2.6|1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||1.2|-2.6|0.452
71887940|NCT01162421|143296922|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.343|TWO_SIDED|95.0|-2.3|0.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.8|-2.3|0.343
71887941|NCT01162421|143296923|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.26||0.22|TWO_SIDED|95.0|-7.3|1.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||1.7|-7.3|0.220
71724015|NCT03458910|142963531|SUPERIORITY|||||||0.751|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.751
71724016|NCT03458910|142963532|SUPERIORITY|||||||0.011|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.011
71724017|NCT03458910|142963533|SUPERIORITY|||||||0.885|||||||ANOVA|p-value reflects effect of interest, a time x condition interaction on scores||||||0.885
71724018|NCT03458910|142963534|SUPERIORITY|||||||0.259||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.259
71724019|NCT03458910|142963535|SUPERIORITY|||||||0.000146||||||p-value reflects time x condition interaction|ANOVA|||2 (time) x 2 (condition) ANOVA to test effects of time, condition, and time x condition interaction||||0.000146
71724020|NCT03458910|142963536|SUPERIORITY|||||||0.463||||||time point x group (2 way) interaction|ANOVA|||||||0.463
71724021|NCT03458910|142963537|SUPERIORITY|||||||0.99||||||time point x group (2 way) interaction|ANOVA|||||||0.990
71724022|NCT03458910|142963538|SUPERIORITY|||||||0.034||||||time point x group (2 way) interaction|ANOVA|||||||0.034
71724023|NCT03458910|142963539|SUPERIORITY|||||||0.398||||||time point x group (2 way) interaction|ANOVA|||||||0.398
71724024|NCT03458910|142963540|SUPERIORITY|||||||0.113||||||time point x group (2 way) interaction|ANOVA|||||||0.113
71724025|NCT03458910|142963541|SUPERIORITY|||||||0.637||||||time point x group (2 way) interaction|ANOVA|||||||0.637
71724026|NCT03458910|142963542|SUPERIORITY|time x condition interaction in CRP for younger adults||||||0.133|||||||ANOVA|||||||0.133
71724027|NCT03458910|142963543|SUPERIORITY|time x condition interaction in CRP for older adults||||||0.402|||||||ANOVA|||||||0.402
71724028|NCT03458910|142963544|SUPERIORITY|time x condition interaction in cytokine IL-1b for younger adults||||||0.236||||||p value for time x condition interaction effect|ANOVA|||||||0.236
71724029|NCT03458910|142963545|SUPERIORITY|time x condition interaction in cytokine IL-1b for older adults||||||0.6||||||p value for time x condition interaction effect|ANOVA|||||||0.600
71724030|NCT03458910|142963546|SUPERIORITY|time x condition interaction in cytokine IL-6 for younger adults||||||0.788||||||p value for time x condition interaction effect|ANOVA|||||||0.788
71724031|NCT03458910|142963547|SUPERIORITY|time x condition interaction in cytokine IL-6 for older adults||||||0.917||||||p value for time x condition interaction effect|ANOVA|||||||0.917
71724032|NCT03458910|142963548|SUPERIORITY|time x condition interaction in cytokine IL-8 for younger adults||||||0.844||||||p value for time x condition interaction effect|ANOVA|||||||0.844
71724033|NCT03458910|142963549|SUPERIORITY|time x condition interaction in cytokine IL-8 for older adults||||||0.75||||||p value for time x condition interaction effect|ANOVA|||||||0.750
71724034|NCT03458910|142963550|SUPERIORITY|time x condition interaction in cytokine TNF-a for younger adults||||||0.074||||||p value for time x condition interaction effect|ANOVA|||||||0.074
71724035|NCT03458910|142963551|SUPERIORITY|time x condition interaction in cytokine TNF-a for older adults||||||0.0505||||||p value for time x condition interaction effect|ANOVA|||||||0.0505
71724036|NCT03458910|142963566|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.022
71724037|NCT03458910|142963567|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||An independent t-test was performed to compare the two groups.||||0.455
71724038|NCT03458910|142963568|SUPERIORITY|||||||0.022|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.022
71724039|NCT03458910|142963569|SUPERIORITY|||||||0.455|||||||ANOVA|||A 2 (time: pre, post) X 2 (condition: HRV-increase, HRV-decrease) ANOVA was performed.||||0.455
71724040|NCT03458910|142963570|SUPERIORITY|||||||0.462||||||time point x group (2 way) interaction|ANOVA|||||||0.462
71724041|NCT03458910|142963571|SUPERIORITY|||||||0.305||||||time point x group (2 way) interaction|ANOVA|||||||0.305
71724042|NCT03458910|142963572|SUPERIORITY|||||||0.804||||||time point x group (2 way) interaction|ANOVA|||||||0.804
71724043|NCT03458910|142963573|SUPERIORITY|||||||0.141||||||time point x group (2 way) interaction|ANOVA|||||||0.141
71724044|NCT03458910|142963574|SUPERIORITY|||||||0.292||||||time point x group(2 way) interaction|ANOVA|||||||0.292
71887942|NCT01162421|143296923|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-11.0|-3.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-3.3|-11.0|<0.001
71724045|NCT03458910|142963575|SUPERIORITY|||||||0.905||||||time point x group (2 way) interaction|ANOVA|||||||0.905
71724046|NCT03458910|142963576|SUPERIORITY|||||||0.641||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for younger adults||||0.641
71724047|NCT03458910|142963577|SUPERIORITY|||||||0.813||||||p value for time x condition x error type interaction effect|ANOVA|||time x condition x error type interaction in Sustained Attention to Response Task (SART) for older adults||||0.813
71724048|NCT03458910|142963578|SUPERIORITY|||||||0.695|||||||ANOVA|||Hits during recognition task for younger adults||||.695
71724049|NCT03458910|142963579|SUPERIORITY|||||||0.27|||||||ANOVA|||Hits during recognition task for older adults||||.270
71724050|NCT03458910|142963580|SUPERIORITY|||||||0.102|||||||ANOVA|||False alarms during recognition task for younger adults||||.102
71724051|NCT03458910|142963581|SUPERIORITY|||||||0.257|||||||ANOVA|||False alarms during recognition task for older adults||||.257
71724052|NCT03458910|142963582|SUPERIORITY|||||||0.067|||||||ANOVA|||Group difference for recall for younger adults||||.067
71724053|NCT03458910|142963583|SUPERIORITY|||||||0.117|||||||ANOVA|||Group difference for recall for older adults||||.117
71724054|NCT03458910|142963584|SUPERIORITY|||||||0.558||||||p value for time x condition interaction effect|ANOVA|||time x condition x collection interaction in cortisol levels for younger adults||||0.558
71724055|NCT01450696|142963613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.2401|TWO_SIDED|95.0|0.86|1.78|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 milliliters per minute \[mL/min\] and greater than or equal to \[≥\] 60 mL/min). Hazard ratio was estimated by Cox regression.||1.78|0.86|0.2401
71724056|NCT01450696|142963613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.1285|TWO_SIDED|95.0|0.92|1.88|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||1.88|0.92|0.1285
71724057|NCT01450696|142963615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9931|TWO_SIDED|95.0|0.49|2.04|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.04|0.49|0.9931
71724058|NCT01450696|142963615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9458|TWO_SIDED|95.0|0.52|2.02|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.02|0.52|0.9458
71724059|NCT01450696|142963617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.6759|TWO_SIDED|95.0|0.63|2.02|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.||2.02|0.63|0.6759
71724060|NCT01450696|142963617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.5764|TWO_SIDED|95.0|0.67|2.05|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.||2.05|0.67|0.5764
71724061|NCT01450696|142963618|SUPERIORITY_OR_OTHER||Difference in response rates|-7.58||||0.5402|TWO_SIDED|95.0|-31.75|16.6|||Chi-squared|||The 95% CI for difference in response rates was constructed using the normal approximation to the binomial distribution.||16.60|-31.75|0.5402
71724062|NCT01450696|142963618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.28|1.96||||||||1.96|0.28|
71724063|NCT04590404|142963720|SUPERIORITY||Odds Ratio (OR)|1.18||||0.461|TWO_SIDED|95.0|0.76|1.82|||Regression, Logistic|Adjusted for arm, randomization strata (cigarettes/day (CPD), insurance category, cardiac admission, NMR category), \& plan to quit after discharge||The primary outcome was biochemically-verified self-reported 7-day point prevalence abstinence (7dPPA) at 6 months. We modeled outcomes using logistic regression adjusted for randomization stratification factors and plan to quit (stay quit vs. try).||1.82|0.76|0.461
71724064|NCT04113018|142963808|SUPERIORITY||Response rate|0.5385||||0.375|TWO_SIDED|95.0|0.3718|0.6991|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.||0.6991|0.3718|0.375
71724065|NCT04113018|142963815|OTHER|Estimation only|Rate|0.0513|||||TWO_SIDED|95.0|0.0063|0.1732|||||Confidence interval estimated using the Clopper Pearson method.|||0.1732|0.0063|
71724066|NCT04113018|142963816|OTHER|Estimation only.|Rate|0.0256|||||TWO_SIDED|95.0|0.0006|0.1348|||||Confidence interval estimated using the Clopper Pearson method.|||0.1348|0.0006|
71724067|NCT06099223|142963823|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71887943|NCT01162421|143296923|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.05|TWO_SIDED|95.0|-7.5|0.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||0.0|-7.5|0.050
71657653|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71724068|NCT06099223|142963824|SUPERIORITY|||||||0.029|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.029
71657654|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71724069|NCT06099223|142963826|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71724070|NCT06099223|142963827|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71724071|NCT06099223|142963828|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||0.61
71724072|NCT06099223|142963829|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
71724073|NCT06099223|142963830|SUPERIORITY|||||||0.11|||||||Fisher Exact|||||||0.11
71724074|NCT06099223|142963831|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71724075|NCT06099223|142963832|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71724076|NCT06099223|142963833|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
71724077|NCT06099223|142963834|SUPERIORITY|||||||0.147|||||||t-test, 2 sided|||||||0.147
71724078|NCT06099223|142963835|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
71724079|NCT06099223|142963836|SUPERIORITY|||||||0.41|||||||Chi-squared|||||||0.41
71724080|NCT06099223|142963837|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71769623|NCT02446743|143039198|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|54.0|||||TWO_SIDED|95.0|45.2|61.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||61.1|45.2|
71657655|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71724081|NCT06099223|142963838|SUPERIORITY|||||||0.58|||||||Chi-squared|||||||0.58
71724082|NCT06099223|142963840|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71724083|NCT06099223|142963841|SUPERIORITY|||||||0.919|||||||ANCOVA|||||||0.919
71724084|NCT02488135|142963848|NON_INFERIORITY|An a priori sample size was calculated using a non-inferiority limit (d) set at 25%, significance level (α) of 5% and power of 80%. We assumed that success in each group would be 93% based on the literature examining anterior nasal packing in ideal conditions and considering our selection criteria in the Floseal® (Baxter, USA) population. Attrition was assumed to be 0% due to the short duration of treatment. This yielded 26 participants with 13 patients in each study arm.||||||1|||||||Fisher Exact|||||||1.000
71724085|NCT02488135|142963849|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during placement.||||0.0022
71724086|NCT02488135|142963849|SUPERIORITY|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups for pain during treatment.||||0.0007
71724087|NCT02488135|142963849|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||Comparison between scores for pain during removal.||||0.0021
71724088|NCT02791516|142963857|SUPERIORITY||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|7.6|11.5|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||11.5|7.6|<0.001
71724089|NCT02791516|142963858|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|1.4|3.7|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.7|1.4|<0.001
71724090|NCT02791516|142963859|SUPERIORITY||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.7||0.004|TWO_SIDED|95.0|0.7|3.6|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.||||3.6|0.7|0.004
71724091|NCT03479541|142963865|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.097||||0.013|TWO_SIDED|95.0|-0.173|-0.02||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.020|-0.173|0.013
71724092|NCT03479541|142963866|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.073||||0.013|TWO_SIDED|95.0|-0.13|-0.016||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.016|-0.130|0.013
71724093|NCT03479541|142963867|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.098||||0.01|TWO_SIDED|95.0|0.024|0.173||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.173|0.024|0.010
71724094|NCT03479541|142963868|OTHER|||||||0.5158|||||||Wilcoxon (Mann-Whitney)|||||||0.5158
71724095|NCT03479541|142963869|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0404||||0.45|TWO_SIDED|95.0|-0.0648|0.146||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.146|-0.0648|0.450
71724096|NCT03479541|142963870|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the reference. Values were log-transformed for model assumptions.|Slope|0.05353||||0.6039|TWO_SIDED|95.0|-0.1503|0.2574||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Horizontal DVA Lines Lost||0.2574|-0.1503|0.6039
71769624|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.4|5.0|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.0|-8.4|
71887944|NCT01162421|143296923|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.95||0.725|TWO_SIDED|95.0|-4.6|3.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||3.2|-4.6|0.725
71724097|NCT03479541|142963870|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time point (pre-physical therapy and post-physical therapy), and group x time point injury interaction with random intercepts, covariates (age, gender, Initial SCAT symptom severity total score, and days since injury before physical therapy), and inverse probability weights. Later Physical Therapy Group and pre-physical therapy time point served as the references. Values were log-transformed for model assumptions.|Slope|-0.235||||0.0414|TWO_SIDED|95.0|-0.461|-0.0093||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change from pre-physical therapy to post-physical therapy time points (the interaction effect of the mixed model analysis).|Analysis for Vertical DVA Lines Lost||-0.0093|-0.461|0.0414
71769625|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|vaccine group difference|29.0|||||TWO_SIDED|95.0|12.1|43.0|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||43.0|12.1|
71724098|NCT03479541|142963871|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.028||||0.387|TWO_SIDED|95.0|-0.09|0.035||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.035|-0.090|0.387
71724099|NCT03479541|142963872|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.008||||0.135|TWO_SIDED|95.0|-0.003|0.019||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.019|-0.003|0.135
71769626|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|46.0|||||TWO_SIDED|95.0|33.6|57.1|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||57.1|33.6|
71769627|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-8.0|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-8.0|
71887945|NCT01162421|143296923|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.31||0.837|TWO_SIDED|95.0|-5.1|4.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||4.1|-5.1|0.837
71724100|NCT03479541|142963873|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0107||||0.406|TWO_SIDED|95.0|-0.036|0.0146||a priori threshold p \< 0.05|Mixed Models Analysis||||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.0146|-0.0360|0.406
71724101|NCT03479541|142963874|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00391||||0.083|TWO_SIDED|95.0|-0.00052|0.00835||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.00835|-0.00052|0.083
71724102|NCT03479541|142963875|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.24|TWO_SIDED|95.0|-0.007|0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFi condition||0.002|-0.007|0.240
71724103|NCT03479541|142963875|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.005||||0.003|TWO_SIDED|95.0|-0.009|-0.002||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for EcFo condition||-0.002|-0.009|0.003
71724104|NCT03479541|142963876|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0112||||0.042|TWO_SIDED|95.0|-0.0219|-0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Average Lap Time||-0.0004|-0.0219|0.042
71724105|NCT03479541|142963876|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0111||||0.0311|TWO_SIDED|95.0|-0.0211|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Average Lap Time||-0.0010|-0.0211|0.0311
71724106|NCT03479541|142963877|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00029||||0.3226|TWO_SIDED|95.0|-0.0003|0.00087||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Gait Speed||0.00087|-0.0003|0.3226
71724107|NCT03479541|142963877|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00035||||0.2218|TWO_SIDED|95.0|-0.0002|0.0009||a priori threshold p \< 0.05|Mixed Models Analysis|||Analysis for Auditory Stroop Gait Speed|The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|0.00090|-0.0002|0.2218
71724108|NCT03479541|142963878|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.161||||0.0742|TWO_SIDED|95.0|-0.0159|0.338||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task 180 Degree Turn Velocity||0.338|-0.0159|0.0742
71724109|NCT03479541|142963878|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.217||||0.0121|TWO_SIDED|95.0|0.048|0.385||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop 180 Degree Turn Velocity||0.385|0.0480|0.0121
71887946|NCT01162421|143296923|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.83||0.661|TWO_SIDED|95.0|-4.5|2.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||2.9|-4.5|0.661
71724110|NCT03479541|142963879|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.00063||||0.8906|TWO_SIDED|95.0|-0.0084|0.00961||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Single Task Percentage of Double Support Time of Gait Cycle||0.00961|-0.0084|0.8906
71724111|NCT03479541|142963879|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.8447|TWO_SIDED|95.0|-0.0107|0.00874||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for Auditory Stroop Percentage of Double Support Time of Gait Cycle||0.00874|-0.0107|0.8447
71724112|NCT03479541|142963880|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0003||||0.013|TWO_SIDED|95.0|-0.0005|-0.0001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Visual Weight (VS/EO)||-0.0001|-0.0005|0.013
71724113|NCT03479541|142963880|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.78|TWO_SIDED|95.0|-0.0003|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Vestibular Weight (SS+VS/EO)||0.0004|-0.0003|0.780
71724114|NCT03479541|142963881|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.235|||<|0.001|TWO_SIDED|95.0|-0.361|-0.11||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (VS/EO)||-0.110|-0.361|<0.001
71724115|NCT03479541|142963881|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.142||||0.002|TWO_SIDED|95.0|-0.233|-0.052||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Time Delay (SS+VS/EO)||-0.052|-0.233|0.002
71724116|NCT03479541|142963882|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0003||||0.237|TWO_SIDED|95.0|-0.0002|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (VS/EO)||0.0007|-0.0002|0.237
71724117|NCT03479541|142963882|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0008||||0.002|TWO_SIDED|95.0|0.0003|0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Stiffness (SS+VS/EO)||0.001|0.0003|0.002
71724118|NCT03479541|142963883|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0001||||0.247|TWO_SIDED|95.0|-0.0001|0.0004||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (VS/EO)||0.0004|-0.0001|0.247
71887947|NCT01162421|143296924|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.156|TWO_SIDED|95.0|-4.4|0.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.7|-4.4|0.156
71887948|NCT01162421|143296924|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-6.1|-1.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-1.9|-6.1|<0.001
71887949|NCT01162421|143296924|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.19||0.04|TWO_SIDED|95.0|-4.9|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9||-0.1|-4.9|0.040
71724119|NCT03479541|142963883|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|0.0004||||0.008|TWO_SIDED|95.0|0.0001|0.0007||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Normalized Damping (SS+VSEO)||0.0007|0.0001|0.008
71769628|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|27.8|54.5|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||54.5|27.8|
71769629|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|vaccine group difference|60.0|||||TWO_SIDED|95.0|47.9|69.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||69.6|47.9|
71769630|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.1|5.4|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||5.4|-1.1|
71769631|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|28.0|||||TWO_SIDED|95.0|19.1|34.9|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.||34.9|19.1|
71769632|NCT02446743|143039198|OTHER|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B\_0\_1) Difference|vaccine group difference|39.0|||||TWO_SIDED|95.0|31.6|46.6|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||46.6|31.6|
71769633|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-4.9|6.7|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||6.7|-4.9|
71830179|NCT01420549|143165167|NON_INFERIORITY|The non-inferiority assessment was analyzed by the bilateral confidence interval (95%) for the ratio of the mean LDLfinal/LDLbaseline of the R/E combination, compared to the mean LDLfinal/LDLbaseline of the S/E combination and the bilateral confidence interval (95%) for the difference between the two means of the percentage variation of LDL-C in the treatments (\[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)R+E\] - \[(LDLfinal - LDLbaseline)/LDLbaseline))\*100)S+E\].|Median Difference (Final Values)|-10.32|STANDARD_ERROR_OF_MEAN|3.33||0.0013|TWO_SIDED|95.0|-16.94|-3.7|||ANCOVA|Estimates for treatment effect and their 95% confidence intervals were exponentiated to produce estimates of percentage change.|Mean Percentage Change LDL- C (%)|Rosuvastatin + Ezetimibe versus Simvastatin + Ezetimibe||-3.70|-16.94|0.0013
71830180|NCT04036058|143165168|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
71769634|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|25.0|||||TWO_SIDED|95.0|9.7|37.1|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||37.1|9.7|
71887950|NCT01162421|143296924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.14||0.492|TWO_SIDED|95.0|-3.1|1.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||1.5|-3.1|0.492
71887951|NCT01162421|143296924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.649|TWO_SIDED|95.0|-3.2|2.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||2.0|-3.2|0.649
71887952|NCT01162421|143296924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.464|TWO_SIDED|95.0|-3.0|1.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||1.4|-3.0|0.464
71769635|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72\_41) vs. Group B\_0\_1 (V72\_41)\] Difference|Vaccine group difference|37.0|||||TWO_SIDED|95.0|25.1|47.0|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||47.0|25.1|
71769636|NCT02446743|143039198|OTHER|3 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-3.9|7.6|||Miettinen and Nurminen score method|||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||7.6|-3.9|
71830181|NCT04036058|143165169|SUPERIORITY|||||||0.0435|||||||t-test, 2 sided|||||||0.0435
71830182|NCT04036058|143165170|SUPERIORITY|||||||0.1158|||||||t-test, 2 sided|||||||0.1158
71887953|NCT01162421|143296925|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.3|STANDARD_ERROR_OF_MEAN|5.08||0.018|TWO_SIDED|95.0|-22.5|-2.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||-2.2|-22.5|0.018
71830183|NCT04036058|143165171|SUPERIORITY|||||||0.0898|||||||t-test, 2 sided|||||||0.0898
71887954|NCT01162421|143296925|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-37.3|-13.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6||-13.7|-37.3|<0.001
71724120|NCT03479541|142963884|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.003|TWO_SIDED|95.0|-0.006|-0.001||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked Center of Mass (CoM) Sway (VS/EO)||-0.001|-0.006|0.003
71724121|NCT03479541|142963884|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.001||||0.004|TWO_SIDED|95.0|-0.003|-0.0005||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Evoked CoM Sway (SS+VS/EO)||-0.0005|-0.003|0.004
71724122|NCT03479541|142963885|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.004||||0.031|TWO_SIDED|95.0|-0.007|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (VS/EO)||-0.0003|-0.007|0.031
71724123|NCT03479541|142963885|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.003||||0.003|TWO_SIDED|95.0|-0.005|-0.0003||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|Analysis for CSMI Outcome - Internal Sensory Noise (SS+VS/EO)||-0.0003|-0.005|0.003
71724124|NCT03479541|142963886|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age and gender), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0321||||0.3221|TWO_SIDED|95.0|-0.0957|0.0315||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0315|-0.0957|0.3221
71724125|NCT03479541|142963887|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0136||||0.336|TWO_SIDED|95.0|-0.0413|0.0142||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||0.0142|-0.0413|0.336
71724126|NCT03479541|142963888|OTHER|Linear mixed effect model containing fixed effects for group (earlier or later), time since injury, and group x time since injury interaction with random intercepts, covariates (age, gender, and Initial SCAT symptom severity total score), and inverse probability weights. Later Physical Therapy Group served as the reference.|Slope|-0.0406||||0.033|TWO_SIDED|95.0|-0.0779|-0.0032||a priori threshold p \< 0.05|Mixed Models Analysis||The slope estimate is the group difference (Early Physical Therapy Group - Later Physical Therapy Group) in change per day per day (the interaction effect of the mixed model analysis).|||-0.0032|-0.0779|0.033
71830184|NCT04036058|143165172|SUPERIORITY|||||||0.114|||||||t-test, 2 sided|||||||0.114
71830185|NCT03351075|143165180|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5163|TWO_SIDED|95.0|-5.28|2.65||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The sample size was based on comparing the changes for the primary outcome measure (PDI-DLV) at 12 months after surgery. The calculation was based on comparing the values at 12 months. Assuming a coefficient of variation (CV) equal to 0.5, 87 participants per group were needed based on a two-sample pooled t-test of a mean ratio with lognormal data and α=0.05 to detect with 80% power a difference of 20% in PDI. To anticipate a drop-out ratio of 5%, a total of 184 subjects were needed.||2.65|-5.28|0.5163
71887955|NCT01162421|143296925|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|5.84||0.113|TWO_SIDED|95.0|-21.0|2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||2.3|-21.0|0.113
71887956|NCT01162421|143296925|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|5.72||0.544|TWO_SIDED|95.0|-14.9|7.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||7.9|-14.9|0.544
71887957|NCT01162421|143296925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.96||0.916|TWO_SIDED|95.0|-12.5|11.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||11.2|-12.5|0.916
71724127|NCT02644096|142963889|SUPERIORITY_OR_OTHER||||||<|0.05||||||Changes in physical function after 3 months|unpaired t-test|||"Power calculation in this study was based on findings in a previous cross-sectional study.~The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups."||||<0.05
71724128|NCT03224403|142963897|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71724129|NCT03224403|142963897|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71769637|NCT02446743|143039198|OTHER|7 Days Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|28.0|||||TWO_SIDED|95.0|20.2|36.6|||Miettinen and Nurminen score method|||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||36.6|20.2|
71724130|NCT03224403|142963897|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71724131|NCT03224403|142963897|SUPERIORITY|||||||0.035||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.035
71724132|NCT03224403|142963897|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||<0.001
71724133|NCT03224403|142963898|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71724134|NCT03224403|142963898|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71724135|NCT03224403|142963898|SUPERIORITY||||||<|0.001||||||The significance threshold level was 0.049 (two-sided). P-values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test from SAS PROC LIFETEST|||||||<0.001
71724136|NCT03224403|142963898|SUPERIORITY|||||||0.671||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.671
71724137|NCT03224403|142963898|SUPERIORITY|||||||0.487||||||The significance threshold level was 0.049 (two-sided). P-values are from the comparison of median survival time using the bootstrap re-sampling method.|bootstrap re-sampling method|||||||0.487
71724138|NCT03224403|142963899|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724139|NCT03224403|142963900|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71887958|NCT01162421|143296925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.86||0.983|TWO_SIDED|95.0|-11.8|11.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||11.6|-11.8|0.983
71887959|NCT01162421|143296926|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.96||0.641|TWO_SIDED|95.0|-12.2|7.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.6|-12.2|0.641
71887960|NCT01162421|143296926|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.61||0.358|TWO_SIDED|95.0|-16.4|6.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||6.0|-16.4|0.358
71887961|NCT01162421|143296926|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|5.58||0.352|TWO_SIDED|95.0|-5.9|16.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||16.4|-5.9|0.352
71724140|NCT03224403|142963901|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724141|NCT03224403|142963902|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724142|NCT03224403|142963903|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724143|NCT03224403|142963904|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724144|NCT03224403|142963905|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724145|NCT03224403|142963906|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724146|NCT03224403|142963907|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724147|NCT03224403|142963908|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724148|NCT03224403|142963909|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724149|NCT03224403|142963910|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724150|NCT03224403|142963911|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724151|NCT03224403|142963912|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71887962|NCT01162421|143296926|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|5.28||0.99|TWO_SIDED|95.0|-10.5|10.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||10.6|-10.5|0.990
71887963|NCT01162421|143296926|SUPERIORITY_OR_OTHER||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|5.36||0.238|TWO_SIDED|95.0|-4.3|17.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||17.1|-4.3|0.238
71887964|NCT01162421|143296926|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.54||0.207|TWO_SIDED|95.0|-4.0|18.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||18.1|-4.0|0.207
71887965|NCT01162421|143296927|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.28||0.85|TWO_SIDED|95.0|-11.5|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||9.5|-11.5|0.850
71887966|NCT01162421|143296927|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|5.49||0.129|TWO_SIDED|95.0|-19.4|2.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.5|-19.4|0.129
71887967|NCT01162421|143296927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.62||0.937|TWO_SIDED|95.0|-10.8|11.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||11.6|-10.8|0.937
71887968|NCT01162421|143296927|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.59||0.67|TWO_SIDED|95.0|-13.5|8.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||8.8|-13.5|0.670
71887969|NCT01162421|143296927|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|5.67||0.341|TWO_SIDED|95.0|-5.9|16.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||16.7|-5.9|0.341
71887970|NCT01162421|143296927|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|6.13||0.621|TWO_SIDED|95.0|-9.2|15.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||15.3|-9.2|0.621
71887971|NCT01162421|143296928|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.29||0.697|TWO_SIDED|95.0|-5.3|7.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.9|-5.3|0.697
71887972|NCT01162421|143296928|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.51||0.744|TWO_SIDED|95.0|-10.5|7.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.5|-10.5|0.744
71724152|NCT03224403|142963913|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71887973|NCT01162421|143296928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.95||0.967|TWO_SIDED|95.0|-7.7|8.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.0|-7.7|0.967
71724153|NCT03224403|142963914|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71769638|NCT02446743|143039198|OTHER|1 month Post Booster/Second Vaccination. Four-fold Increase \[Group 3B (V72P10) vs. Group B\_0\_1 (V72P10)\] Difference|Vaccine group difference|42.0|||||TWO_SIDED|95.0|31.0|51.9|||Miettinen and Nurminen score method|||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen||51.9|31.0|
71769639|NCT03718299|143039206|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Week 52||||<0.001
71724154|NCT03224403|142963915|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71724155|NCT03224403|142963916|SUPERIORITY|||||||0.007|||||||Regression, Logistic|||||||0.007
71724156|NCT03224403|142963917|SUPERIORITY|||||||0.026|||||||Regression, Logistic|||||||0.026
71724157|NCT03224403|142963918|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.080
71769640|NCT03718299|143039207|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
71887974|NCT01162421|143296928|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.3||0.377|TWO_SIDED|95.0|-3.7|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||9.5|-3.7|0.377
71887975|NCT01162421|143296928|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.5||0.122|TWO_SIDED|95.0|-1.5|12.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||12.4|-1.5|0.122
71887976|NCT01162421|143296928|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|3.42||0.49|TWO_SIDED|95.0|-4.4|9.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.2|-4.4|0.490
71887977|NCT01162421|143296929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.102|TWO_SIDED|95.0|-1.0|0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3||0.1|-1.0|0.102
71887978|NCT01162421|143296929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.29||0.003|TWO_SIDED|95.0|-1.5|-0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||-0.3|-1.5|0.003
71887979|NCT01162421|143296929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.214|TWO_SIDED|95.0|-0.9|0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9||0.2|-0.9|0.214
71887980|NCT01162421|143296929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.339|TWO_SIDED|95.0|-0.8|0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12||0.3|-0.8|0.339
71724158|NCT01456195|142963925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.72|-0.24||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.24|-0.72|<0.001
71724159|NCT01456195|142963925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.0|-0.52||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.52|-1.00|<0.001
71724160|NCT01456195|142963926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.01|TWO_SIDED|95.0|1.2|3.79||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||3.79|1.20|0.010
71724161|NCT01456195|142963926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.48|7.82||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic|||||7.82|2.48|<0.001
71769641|NCT03718299|143039208|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769642|NCT03718299|143039209|SUPERIORITY||Clopper-Pearson|62.2|||||TWO_SIDED|95.0|46.5|76.2||||||||76.2|46.5|
71769643|NCT03718299|143039210|SUPERIORITY||Clopper-Pearson|93.3|||||TWO_SIDED|95.0|81.7|98.6||||||||98.6|81.7|
71769644|NCT03718299|143039211|SUPERIORITY||Clopper-Pearson|78.9|||||TWO_SIDED|95.0|62.7|90.4||||||||90.4|62.7|
71769645|NCT03718299|143039212|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769646|NCT03718299|143039213|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769647|NCT03718299|143039214|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769648|NCT03718299|143039215|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769649|NCT03718299|143039216|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769650|NCT03718299|143039217|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769651|NCT03718299|143039218|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769652|NCT03718299|143039219|SUPERIORITY||Mean (Clopper-Pearson)|24.4|||||TWO_SIDED|95.0|12.9|39.5||||||||39.5|12.9|
71769653|NCT03718299|143039220|SUPERIORITY||Mean (Clopper-Pearson)|17.8|||||TWO_SIDED|95.0|8.0|32.1||||||||32.1|8.0|
71769654|NCT03718299|143039221|SUPERIORITY||Clopper-Pearson|48.9|||||TWO_SIDED|95.0|33.7|64.2||||||||64.2|33.7|
71769655|NCT03718299|143039222|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Activity Impairment||||<0.001
71769656|NCT03718299|143039222|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Total Work Productivity Impairment||||<0.001
71724162|NCT01456195|142963927|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.59||0.003|TWO_SIDED|95.0|-22.7|-4.6||Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.6|-22.7|0.003
71724163|NCT01456195|142963927|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.4|-13.2||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-13.2|-31.4|<0.001
71769657|NCT03718299|143039223|SUPERIORITY||Mean|79.5|STANDARD_DEVIATION|20.06|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time- Effectiveness||||
71769658|NCT03718299|143039223|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||Treatment Satisfaction Questionnaire for Medication over time-Side Effects||||<0.001
71769659|NCT03718299|143039223|SUPERIORITY||Mean|82.2|STANDARD_DEVIATION|16.35|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Convenience||||
71769660|NCT03718299|143039223|SUPERIORITY||Mean|81.9|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||Treatment Satisfaction Questionnaire for Medication over time - Global Satisfaction||||
71769661|NCT03718299|143039224|SUPERIORITY||Mean|8.7|STANDARD_DEVIATION|2.01|||TWO_SIDED|||||||||Improvement in Symptoms||||
71769662|NCT03718299|143039224|SUPERIORITY||Mean|8.3|STANDARD_DEVIATION|2.3|||TWO_SIDED|||||||||Speed of Symptom Improvement||||
71769663|NCT03718299|143039224|SUPERIORITY||Mean|9.1|STANDARD_DEVIATION|1.7|||TWO_SIDED|||||||||Frequency of Taking Medication||||
71769664|NCT03718299|143039224|SUPERIORITY||Mean|9.6|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||Side Effects||||
71769665|NCT03718299|143039225|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71769666|NCT01198158|143039243|SUPERIORITY|||||||0.739|||||||Log Rank|OS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors.||||||0.739
71769667|NCT01198158|143039244|SUPERIORITY|||||||0.832|||||||Log Rank|PFS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors||||||0.832
71769668|NCT01205581|143039251|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher Exact|||||||0.78
71769669|NCT01205581|143039254|SUPERIORITY_OR_OTHER|||||||0.48|||||||Fisher Exact|||||||0.48
71769670|NCT01205581|143039255|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||||||0.51
71769671|NCT01205581|143039256|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
71769672|NCT01205581|143039257|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
71769673|NCT01205581|143039258|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
71769674|NCT01063712|143039273|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|||It is not a analysis of two groups. Only one group of patients was analyzed.||||<0.01
71769675|NCT01063712|143039274|SUPERIORITY_OR_OTHER||||||<|0.01|||||||percentage|The analysis was made on the basis of the percentage of patients with completely regressed dilation.||It is a one arm clinical study. No comparison between groups was made.||||<0.01
71769676|NCT05033002|143039284|SUPERIORITY||Slope|-0.41|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||<.0001
71769677|NCT05033002|143039284|SUPERIORITY||Slope|0.002|||<|0.0001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||<.0001
71887981|NCT01162421|143296929|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.973|TWO_SIDED|95.0|-0.6|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18||0.6|-0.6|0.973
71887982|NCT01162421|143296929|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.755|TWO_SIDED|95.0|-0.6|0.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24||0.5|-0.6|0.755
71887983|NCT01162421|143296930|SUPERIORITY_OR_OTHER||Difference in percentage|9.4||||0.316|TWO_SIDED|95.0|-7.09|25.13|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||25.13|-7.09|0.316
71887984|NCT01162421|143296930|SUPERIORITY_OR_OTHER||Difference in percentage|24.5||||0.014|TWO_SIDED|95.0|6.09|42.85|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||42.85|6.09|0.014
71887985|NCT01162421|143296930|SUPERIORITY_OR_OTHER||Difference in percentage|-3.2||||0.762|TWO_SIDED|95.0|-24.1|17.66|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||17.66|-24.10|0.762
71887986|NCT01162421|143296930|SUPERIORITY_OR_OTHER||Difference in percentage|13.0||||0.22|TWO_SIDED|95.0|-7.46|33.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||33.54|-7.46|0.220
71724164|NCT01456195|142963928|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.8|STANDARD_ERROR_OF_MEAN|17.17||0.1|TWO_SIDED|95.0|-63.2|5.7||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.7|-63.2|0.100
71724165|NCT01456195|142963928|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.0|STANDARD_ERROR_OF_MEAN|17.7||0.096|TWO_SIDED|95.0|-65.5|5.5||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA|||||5.5|-65.5|0.096
71724166|NCT01340625|142963930|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.84|||||TWO_SIDED|90.0|100.91|115.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||115.24|100.91|
71724167|NCT01340625|142963931|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.03|||||TWO_SIDED|90.0|96.74|111.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.88|96.74|
71724168|NCT01340625|142963932|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.97|||||TWO_SIDED|90.0|95.73|108.62|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.62|95.73|
71724169|NCT01340625|142963933|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.24|||||TWO_SIDED|90.0|90.04|102.86|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.86|90.04|
71769678|NCT05033002|143039285|SUPERIORITY||Slope|0.06||||0.002|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.002
71887987|NCT01162421|143296930|SUPERIORITY_OR_OTHER||Difference in percentage|-3.5||||0.747|TWO_SIDED|95.0|-24.9|17.86|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||17.86|-24.90|0.747
71887988|NCT01162421|143296930|SUPERIORITY_OR_OTHER||Difference in percentage|-4.4||||0.701|TWO_SIDED|95.0|-26.8|18.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||18.01|-26.80|0.701
71887989|NCT01162421|143296931|SUPERIORITY_OR_OTHER||Difference in percentage|10.5||||0.318|TWO_SIDED|95.0|-9.83|30.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||30.78|-9.83|0.318
71887990|NCT01162421|143296931|SUPERIORITY_OR_OTHER||Difference in percentage|22.7||||0.047|TWO_SIDED|95.0|1.03|44.39|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6||44.39|1.03|0.047
71887991|NCT01162421|143296931|SUPERIORITY_OR_OTHER||Difference in percentage|5.0||||0.668|TWO_SIDED|95.0|-17.74|27.71|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||27.71|-17.74|0.668
71887992|NCT01162421|143296931|SUPERIORITY_OR_OTHER||Difference in percentage|7.8||||0.5|TWO_SIDED|95.0|-14.88|30.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.56|-14.88|0.500
71887993|NCT01162421|143296931|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
71887994|NCT01162421|143296931|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
71887995|NCT01162421|143296932|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||28.00|-12.17|0.444
71769679|NCT05033002|143039285|SUPERIORITY||Slope|-0.0003||||0.01|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.010
71887996|NCT01162421|143296932|SUPERIORITY_OR_OTHER||Difference in percentage|20.1||||0.076|TWO_SIDED|95.0|-1.53|41.83|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||41.83|-1.53|0.076
71769680|NCT05033002|143039286|SUPERIORITY||Slope|0.05||||0.001|TWO_SIDED|||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.|||||.001
71769681|NCT05033002|143039286|SUPERIORITY||Slope|-0.0002||||0.032|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.032
71769682|NCT05033002|143039287|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.506|TWO_SIDED||||||t-test, 2 sided|||||||0.506
71769683|NCT05033002|143039288|SUPERIORITY|||||||0.441||||||The p-value is for the t-test of the coefficient of linear (TimeXGroup) trends.|Mixed Models Analysis|The estimated value is for the slope of linear (TimeXGroup) trends. Controlled for significant covariates.||||||.441
71769684|NCT05033002|143039288|SUPERIORITY||Slope|0.0002||||0.734|TWO_SIDED|||||The p-value is for the t-test of the coefficient of quadratic (TimeXTimeXGroup) trends.|Mixed Models Analysis||The estimated value is for the slope of quadratic (TimeXTimeXGroup) trends. Controlled for significant covariates.|||||.734
71769685|NCT03702244|143039289|SUPERIORITY|Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events.|Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.2|0.41|||Log Rank||Hazard ratio was adjusted for age, sex, and coronary artery disease equivalent (diabetes, history of peripheral artery disease or cerebrovascular disease), and intended first test strata (invasive or noninvasive).|Sample size and power calculations for this study are based on the hypothesis that the precision evaluation arm is superior to the usual care arm on the time-to-first event of the composite 3-component endpoint: all-cause death, non-fatal MI, or invasive cardiac catheterization without obstructive CAD over a 12-month of follow-up. Time to event analysis will use the date of the event, including the date of catheterization at which the absence of obstructive CAD is demonstrated.||0.41|0.20|<.001
71769686|NCT01895361|143039344|OTHER||Hodges-Lehmann median absolute diff.|-1.01|||=|0.01|TWO_SIDED|95.0|-2.0|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crisis history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-2.00|= 0.010
71769687|NCT01895361|143039344|OTHER||Hodges-Lehmann median absolute diff.|-0.69|||=|0.18|TWO_SIDED|95.0|-1.84|0.02|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.02|-1.84|= 0.180
71769688|NCT01895361|143039345|OTHER||Change vs placebo (%)|-45.3|||||ONE_SIDED|||||||||||||
71769689|NCT01895361|143039345|OTHER||Change vs placebo (%)|-32.6|||||ONE_SIDED|||||||||||||
71769690|NCT01895361|143039346|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.45|TWO_SIDED|95.0|-4.36|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|-4.36|= 0.450
71769691|NCT01895361|143039346|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.837|TWO_SIDED|95.0|-3.9|2.61|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||2.61|-3.90|= 0.837
71769692|NCT01895361|143039347|OTHER||Hazard Ratio (HR)|0.495|||=|0.001|TWO_SIDED|95.0|0.331|0.741|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.741|0.331|= 0.001
71769693|NCT01895361|143039347|OTHER||Hazard Ratio (HR)|0.752|||=|0.136|TWO_SIDED|95.0|0.515|1.097|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.097|0.515|= 0.136
71769694|NCT01895361|143039348|OTHER||Hazard Ratio (HR)|0.534|||=|0.022|TWO_SIDED|95.0|0.329|0.866|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||0.866|0.329|= 0.022
71769695|NCT01895361|143039348|OTHER||Hazard Ratio (HR)|0.693|||=|0.1|TWO_SIDED|95.0|0.44|1.092|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates|||1.092|0.440|= 0.100
71769696|NCT01895361|143039349|OTHER||Hodges-Lehmann median absolute diff.|-1.0|||=|0.015|TWO_SIDED|95.0|-1.98|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.98|= 0.015
71769697|NCT01895361|143039349|OTHER||Hodges-Lehmann median absolute diff.|-0.87|||=|0.12|TWO_SIDED|95.0|-1.77|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|-1.77|= 0.120
71769698|NCT01895361|143039350|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.78|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata||||0.00|0.00|= 0.780
71769699|NCT01895361|143039350|OTHER||Hodges-Lehmann median absolute diff.|0.0|||=|0.868|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.||||0.00|0.00|= 0.868
71769700|NCT02692651|143039367|SUPERIORITY|||||||0.195|||||||Chi-squared, Corrected|||||||0.195
71769701|NCT02692651|143039368|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||||||.99
71769702|NCT02692651|143039369|SUPERIORITY|||||||0.999|||||||Chi-squared, Corrected|||||||.999
71769703|NCT02239120|143039378|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1028|TWO_SIDED|95.0|0.69|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.69|0.1028
71887997|NCT01162421|143296932|SUPERIORITY_OR_OTHER||Difference in percentage|2.7||||0.816|TWO_SIDED|95.0|-20.1|25.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||25.52|-20.10|0.816
71830186|NCT03351075|143165181|SUPERIORITY||Mean Difference (Net)|-0.97||||0.5655|TWO_SIDED|95.0|-4.26|2.33||No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 4 months||2.33|-4.26|0.5655
71724170|NCT01340625|142963934|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.8|||||TWO_SIDED|90.0|93.89|103.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.97|93.89|
71724171|NCT01340625|142963935|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.59|||||TWO_SIDED|90.0|94.91|104.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.50|94.91|
71830187|NCT03351075|143165181|SUPERIORITY||Mean Difference (Net)|-1.07||||0.5592|TWO_SIDED|95.0|-4.64|2.51||P\<.05 was considered significant. No corrections for multiple testing were performed.|multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain-related disability from baseline to 1.5 years||2.51|-4.64|0.5592
71830188|NCT03351075|143165182|SUPERIORITY||Mean Difference (Net)|-2.23||||0.563|TWO_SIDED|95.0|-9.84|5.37||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 4 months||5.37|-9.84|0.5630
71830189|NCT03351075|143165182|SUPERIORITY||Mean Difference (Net)|-4.3||||0.2524|TWO_SIDED|95.0|-11.68|3.09||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 12 months||3.09|-11.68|0.2524
71830190|NCT03351075|143165182|SUPERIORITY||Mean Difference (Net)|-4.8||||0.2315|TWO_SIDED|95.0|-12.69|3.09|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain intensity from baseline to 1.5 years||3.09|-12.69|0.2315
71724172|NCT01668628|142963937|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.||||0.008
71724173|NCT01668628|142963937|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.||||0.008
71724174|NCT01668628|142963937|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group||||0.008
71724175|NCT01668628|142963937|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.||||0.157
71724176|NCT00734604|142963948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|95.0|0.04|0.19||p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.19|0.04|0.001
71830191|NCT03351075|143165183|SUPERIORITY||Mean Difference (Net)|0.47||||0.7494|TWO_SIDED|95.0|-2.39|3.32||No corrections for multiple testing were performed.|Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 4 months.||3.32|-2.39|0.7494
71830192|NCT03351075|143165183|SUPERIORITY||Mean Difference (Net)|-0.25||||0.8617|TWO_SIDED|95.0|-3.09|2.58|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||The difference in change in self-reported central sensitisation symptoms from baseline to 12 months.||2.58|-3.09|0.8617
71724177|NCT00734604|142963949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.872|TWO_SIDED|95.0|-0.06|0.08||p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|LS Mean difference = Tadalafil OaD-Tadalafil PRN|||0.08|-0.06|0.872
71724178|NCT00734604|142963950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.1|0.2||p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.20|0.10|<0.001
71830193|NCT03351075|143165183|SUPERIORITY||Mean Difference (Net)|-0.29||||0.8454|TWO_SIDED|95.0|-3.16|2.59|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported central sensitisation symptoms from baseline to 1.5 years||2.59|-3.16|0.8454
71830194|NCT03351075|143165184|SUPERIORITY||Mean Difference (Net)|1.35||||0.3463|TWO_SIDED|95.0|0.72|2.51|||multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 4 months||2.51|0.72|0.3463
71887998|NCT01162421|143296932|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.485|TWO_SIDED|95.0|-14.61|30.87|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||30.87|-14.61|0.485
71724179|NCT00734604|142963950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.395|TWO_SIDED|95.0|-0.03|0.07||p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.07|-0.03|0.395
71724180|NCT00734604|142963951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.36|-0.25||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.25|-0.36|<0.001
71887999|NCT01162421|143296932|SUPERIORITY_OR_OTHER||Difference in percentage|-2.7||||0.816|TWO_SIDED|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||20.10|-25.52|0.816
71888000|NCT01162421|143296932|SUPERIORITY_OR_OTHER||Difference in percentage|-10.7||||0.358|TWO_SIDED|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.99|-33.38|0.358
71657656|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657657|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657658|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657659|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657660|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657661|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657662|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71724181|NCT00734604|142963951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.2|-0.08||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.08|-0.20|<0.001
71724182|NCT00734604|142963952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.43|-0.27||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.27|-1.43|0.004
71769704|NCT02239120|143039379|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1076|TWO_SIDED|95.0|0.94|1.97|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.97|0.94|0.1076
71888001|NCT01162421|143296933|SUPERIORITY_OR_OTHER||Difference in percentage|11.6||||0.316|TWO_SIDED|95.0|-10.84|33.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||33.99|-10.84|0.316
71724183|NCT00734604|142963952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.29||0.007|TWO_SIDED|95.0|-1.37|-0.22||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.22|-1.37|0.007
71724184|NCT00734604|142963953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.03|0.09||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.09|0.03|<0.001
71724185|NCT00734604|142963953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.06|0.12||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.12|0.06|<0.001
71769705|NCT02239120|143039380|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0892|TWO_SIDED|95.0|0.68|1.03|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.03|0.68|0.0892
71724186|NCT00734604|142963954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.36||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-0.36|-0.91|<0.001
71724187|NCT00734604|142963954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.78|-0.23||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|||||-0.23|-0.78|<0.001
71724188|NCT00734604|142963955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.055|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.055
71724189|NCT00734604|142963955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.046|TWO_SIDED|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.00|-0.44|0.046
71724190|NCT00734604|142963956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.27||0.004|TWO_SIDED|95.0|1.16|6.17||p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||6.17|1.16|0.004
71724191|NCT00734604|142963956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|1.27||0.006|TWO_SIDED|95.0|-6.05|-1.04||p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||-1.04|-6.05|0.006
71724192|NCT00734604|142963958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.05||0.915|TWO_SIDED|95.0|-1.95|2.17||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||2.17|-1.95|0.915
71724193|NCT00734604|142963958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.212|TWO_SIDED|95.0|-3.35|0.74||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.||||0.74|-3.35|0.212
71724194|NCT00734604|142963959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.403|TWO_SIDED|95.0|-0.09|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.09|0.403
71724195|NCT00734604|142963959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.367|TWO_SIDED|95.0|-0.08|0.23||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.23|-0.08|0.367
71769706|NCT02239120|143039381|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1911|TWO_SIDED|95.0|0.73|1.06|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.06|0.73|0.1911
71769707|NCT02239120|143039382|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0354|TWO_SIDED|95.0|0.36|0.96|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||0.96|0.36|0.0354
71769708|NCT02239120|143039383|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8074|TWO_SIDED|95.0|0.66|1.38|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.38|0.66|0.8074
71769709|NCT02239120|143039384|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9064|TWO_SIDED|95.0|0.58|1.83|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.83|0.58|0.9064
71769710|NCT02239120|143039386|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.4352|TWO_SIDED|95.0|0.49|1.36|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.36|0.49|0.4352
71888002|NCT01162421|143296933|SUPERIORITY_OR_OTHER||Difference in percentage|5.1||||0.63|TWO_SIDED|95.0|-15.43|25.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||25.54|-15.43|0.630
71888003|NCT01162421|143296933|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.972|TWO_SIDED|95.0|-20.94|20.21|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||20.21|-20.94|0.972
71769711|NCT02239120|143039387|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.0003|TWO_SIDED|95.0|1.12|1.47|||Regression, Cox|Covariates in model are age(\<or\>= 75years), creatinine clearance \< or \>= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.||||1.47|1.12|0.0003
71769712|NCT00609362|143039394|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is un-adjusted. A priori threshold for significance: 0.05|t-test, 2 sided|||The minimum number of participants was determined by power calculations to be 44 (22 in each group), assuming a difference in change in BMD of 1.7%, a standard deviation of 2%, a power of 80%, and a level of significance of 5%.||||0.055
71769713|NCT00609362|143039395|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||t-test, 2 sided|||||||0.056
71769714|NCT00609362|143039396|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71769715|NCT00548405|143039409|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0084|TWO_SIDED|95.0|0.38|0.87||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.||0.87|0.38|0.0084
71888004|NCT01162421|143296933|SUPERIORITY_OR_OTHER||Difference in percentage|-14.1||||0.186|TWO_SIDED|95.0|-34.83|6.7|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||6.70|-34.83|0.186
71657663|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657664|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657665|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71657666|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657667|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657668|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657669|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657670|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657671|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657672|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657673|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657674|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71657675|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657676|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657677|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657678|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657679|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657680|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657681|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71769716|NCT00548405|143039410|SUPERIORITY_OR_OTHER||Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.65|0.39|<0.0001
71769717|NCT00548405|143039411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.||0.69|0.41|<0.0001
71769718|NCT00548405|143039412|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||<0.0001
71769719|NCT00548405|143039413|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Wei-Lachin|||Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.||||0.0022
71724196|NCT00734604|142963960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.06||0.002|TWO_SIDED|95.0|0.07|0.32||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.32|0.07|0.002
71724197|NCT00734604|142963960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.722|TWO_SIDED|95.0|-0.15|0.1||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.10|-0.15|0.722
71769720|NCT00548405|143039414|SUPERIORITY_OR_OTHER|||||||0.1371|TWO_SIDED||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.||||0.1371
71769721|NCT02582684|143039415|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.9|||||TWO_SIDED|95.0|0.83|0.95|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.95|0.83|
71769722|NCT02582684|143039416|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|Proportion|0.89|||||TWO_SIDED|95.0|0.82|0.94|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.94|0.82|
71769723|NCT02582684|143039417|OTHER|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.85|||||TWO_SIDED|95.0|0.77|0.91|||||Confidence interval was calculated using the Clopper-Pearson exact method.|||0.91|0.77|
71769724|NCT01431300|143039438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.0|STANDARD_DEVIATION|12.0|<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
71769725|NCT01431300|143039438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|19.0|<|0.01||95.0|||||t-test, 2 sided|||contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.||||<0.01
71769726|NCT06054269|143039439|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.004
71769727|NCT06054269|143039439|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.066
71769728|NCT06054269|143039439|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.694
71769729|NCT06054269|143039439|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.408
71830195|NCT03351075|143165184|SUPERIORITY||Mean Difference (Net)|0.86||||0.6613|TWO_SIDED|95.0|0.451|1.66|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1 year||1.66|0.451|0.6613
71830196|NCT03351075|143165184|SUPERIORITY||Mean Difference (Net)|1.26||||0.4908|TWO_SIDED|95.0|0.65|2.42|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical detection sensitivity at the arm from baseline to 1.5 years||2.42|0.65|0.4908
71769730|NCT06054269|143039440|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.164
71724198|NCT00734604|142963961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.65|-0.37||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.37|-0.65|<0.001
71724199|NCT00734604|142963961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.43|-0.16||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||-0.16|-0.43|<0.001
71769731|NCT06054269|143039440|SUPERIORITY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.113
71769732|NCT06054269|143039440|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.404
71769733|NCT06054269|143039440|SUPERIORITY|||||||0.879|||||||Wilcoxon (Mann-Whitney)|||For comparison of post-vaccination geometric mean antibody titers to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.879
71769734|NCT06054269|143039441|SUPERIORITY||||||<|0.001|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||<0.001
71769735|NCT06054269|143039441|SUPERIORITY|||||||0.002|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.002
71769736|NCT06054269|143039441|SUPERIORITY|||||||0.468|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.468
71769737|NCT06054269|143039441|SUPERIORITY|||||||0.057|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.057
71769738|NCT06054269|143039442|SUPERIORITY|||||||0.112|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.112
71769739|NCT06054269|143039442|SUPERIORITY|||||||0.149|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.149
71830197|NCT03351075|143165185|SUPERIORITY||Mean Difference (Net)|0.22||||0.7708|TWO_SIDED|95.0|-1.25|1.69|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 4 months||1.69|-1.25|0.7708
71888005|NCT01162421|143296933|SUPERIORITY_OR_OTHER||Difference in percentage|-12.6||||0.142|TWO_SIDED|95.0|-29.46|4.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||4.26|-29.46|0.142
71888006|NCT01162421|143296933|SUPERIORITY_OR_OTHER||Difference in percentage|-4.0||||0.727|TWO_SIDED|95.0|-20.34|11.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||11.52|-20.34|0.727
71888007|NCT01162421|143296934|SUPERIORITY_OR_OTHER||Difference in percentage|6.8||||0.486|TWO_SIDED|95.0|-9.21|22.22|||Fisher Exact|Two-sided Fisher Exact test.||||22.22|-9.21|0.486
71888008|NCT01162421|143296935|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.13||0.809|TWO_SIDED|95.0|-0.23|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.29|-0.23|0.809
71888009|NCT01162421|143296935|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.132||0.194|TWO_SIDED|95.0|-0.44|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.09|-0.44|0.194
71888010|NCT01162421|143296935|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.132||0.863|TWO_SIDED|95.0|-0.24|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.29|-0.24|0.863
71888011|NCT01162421|143296935|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.129||0.452|TWO_SIDED|95.0|-0.16|0.35||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.35|-0.16|0.452
71888012|NCT01162421|143296935|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.141||0.738|TWO_SIDED|95.0|-0.23|0.33||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.33|-0.23|0.738
71888013|NCT01162421|143296935|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.148||0.572|TWO_SIDED|95.0|-0.21|0.38||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.38|-0.21|0.572
71888014|NCT01162421|143296936|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.299|TWO_SIDED|95.0|-34.05|10.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||10.31|-34.05|0.299
71888015|NCT01162421|143296936|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0||||0.796|TWO_SIDED|95.0|-25.77|19.77|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||19.77|-25.77|0.796
71888016|NCT01162421|143296936|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.54|TWO_SIDED|95.0|-15.3|29.22|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||29.22|-15.30|0.540
71888017|NCT01162421|143296936|SUPERIORITY_OR_OTHER||Difference in percentage|-9.6||||0.392|TWO_SIDED|95.0|-31.39|12.19|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||12.19|-31.39|0.392
71888018|NCT01162421|143296936|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3||||0.776|TWO_SIDED|95.0|-25.96|19.37|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||19.37|-25.96|0.776
71888019|NCT01162421|143296936|SUPERIORITY_OR_OTHER||Difference in percentage|-16.1||||0.166|TWO_SIDED|95.0|-38.64|6.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||6.40|-38.64|0.166
71769740|NCT06054269|143039442|SUPERIORITY|||||||0.101|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.101
71769741|NCT06054269|143039442|SUPERIORITY|||||||0.259|||||||Chi-squared|||For comparison of post-vaccination seroconversion rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.259
71769742|NCT06054269|143039443|SUPERIORITY|||||||0.097|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.097
71657682|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71769743|NCT06054269|143039443|SUPERIORITY|||||||0.733|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.733
71769744|NCT06054269|143039443|SUPERIORITY|||||||0.477|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.477
71769745|NCT06054269|143039443|SUPERIORITY|||||||0.312|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.312
71769746|NCT06054269|143039444|SUPERIORITY|||||||0.22|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H1N1)pdm09 vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.220
71769747|NCT06054269|143039444|SUPERIORITY|||||||0.003|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza A(H3N2) vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.003
71769748|NCT06054269|143039444|SUPERIORITY|||||||0.897|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Victoria vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.897
71769749|NCT06054269|143039444|SUPERIORITY|||||||0.931|||||||Chi-squared|||For comparison of post-vaccination seroprotection rate to the influenza B/Yamagata vaccine virus between recipients of FLUAD Quadrivalent and FluQuadri.||||0.931
71769750|NCT00899392|143039463|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Student's t test|t-test, 2 sided|||||||<0.0001
71769751|NCT00899392|143039464|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann Whitney Test-non parametric||||>0.05
71769752|NCT00899392|143039465|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|paired||||||>0.05
71769753|NCT00899392|143039466|SUPERIORITY_OR_OTHER|||||||0.0053||95.0|||||t-test, 2 sided|||||||0.0053
71769754|NCT04456153|143039533|SUPERIORITY|||||||0.17|||||||GLMM|||||||0.170
71769755|NCT04456153|143039534|SUPERIORITY|||||||0.051|||||||GLMM|||||||0.051
71769756|NCT04456153|143039537|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71769757|NCT04456153|143039538|SUPERIORITY|||||||0.76|||||||trapezoidal method|||||||0.76
71769758|NCT02387476|143039547|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.13|<|0.001|TWO_SIDED|95.0|-1.7|2.9||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean AHI is rounded to a single decimal point in the text of the report (3.0 and 2.4, respectively), in order to be consistent with standard reporting of AHI.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||2.9|-1.7|<0.001
71830198|NCT03351075|143165185|SUPERIORITY||Mean Difference (Net)|0.29||||0.706|TWO_SIDED|95.0|-1.23|1.81|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in warmth detection sensitivity from baseline to 1 year||1.81|-1.23|0.7060
71657683|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71657684|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657685|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657686|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657687|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657688|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657689|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657690|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71657691|NCT02504671|142831745|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657692|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657693|NCT02504671|142831745|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657694|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657695|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71657696|NCT02504671|142831745|OTHER||Difference|29.7|||||TWO_SIDED|95.0|12.7|46.8|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.8|12.7|
71657697|NCT02504671|142831745|OTHER||Difference|37.8|||||TWO_SIDED|95.0|20.3|55.4|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.4|20.3|
71657698|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657699|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657700|NCT02504671|142831745|OTHER||Difference|37.8|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
71657701|NCT02504671|142831745|OTHER||Difference|51.4|||||TWO_SIDED|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||56.1|19.5|
71657702|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71657703|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71657704|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 4, ACR70. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71724200|NCT00734604|142963962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.07|TWO_SIDED|95.0|-0.01|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.22|-0.01|0.070
71724201|NCT00734604|142963962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.637|TWO_SIDED|95.0|-0.14|0.09||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model|||||0.09|-0.14|0.637
71724202|NCT02589665|142963963|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|0.7|12.27||||||||12.27|0.70|
71724203|NCT02589665|142963963|SUPERIORITY||Odds Ratio (OR)|7.22|||||TWO_SIDED|95.0|1.88|27.65||||||||27.65|1.88|
71724204|NCT02589665|142963963|SUPERIORITY||Odds Ratio (OR)|3.61|||||TWO_SIDED|95.0|0.92|14.17||||||||14.17|0.92|
71724205|NCT02589665|142963964|SUPERIORITY||Odds Ratio (OR)|3.95|||||TWO_SIDED|95.0|1.73|8.98||||||||8.98|1.73|
71724206|NCT02589665|142963964|SUPERIORITY||Odds Ratio (OR)|6.78|||||TWO_SIDED|95.0|2.94|15.63||||||||15.63|2.94|
71724207|NCT02589665|142963964|SUPERIORITY||Odds Ratio (OR)|2.78|||||TWO_SIDED|95.0|1.23|6.29||||||||6.29|1.23|
71724208|NCT02589665|142963965|SUPERIORITY|||||||0.986|||||||Mantel Haenszel|||||||0.986
71830199|NCT03351075|143165185|SUPERIORITY||Mean Difference (Net)|0.02||||0.9806|TWO_SIDED|95.0|-1.38|1.42|||Multivariate linear model|||Difference in change in warmth detection sensitivity from baseline to 1.5 years||1.42|-1.38|0.9806
71657705|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-6.8|33.8|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.8|-6.8|
71724209|NCT02589665|142963965|SUPERIORITY|||||||0.553|||||||Mantel Haenszel|||||||0.553
71724210|NCT02589665|142963965|SUPERIORITY|||||||0.56|||||||Mantel Haenszel|||||||0.560
71724211|NCT02589665|142963966|SUPERIORITY||Odds Ratio (OR)|2.29|||||TWO_SIDED|95.0|0.8|6.55||||||||6.55|0.80|
71724212|NCT02589665|142963967|SUPERIORITY||Mean Difference (Final Values)|22.9|||||TWO_SIDED|95.0|11.0|34.9||||||||34.9|11.0|
71724213|NCT02589665|142963967|SUPERIORITY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|8.7|32.3||||||||32.3|8.7|
71724214|NCT02589665|142963967|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|22.5||||||||22.5|-1.0|
71724215|NCT02589665|142963969|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.39|-0.41||||||||-0.41|-1.39|
71724216|NCT02589665|142963969|SUPERIORITY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.54|-0.59||||||||-0.59|-1.54|
71724217|NCT02589665|142963969|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-1.07|-0.11||||||||-0.11|-1.07|
71724218|NCT02589665|142963972|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.31|||Regression, Logistic|||||8.31|1.57|0.003
71724219|NCT02589665|142963972|SUPERIORITY||Odds Ratio (OR)|6.54|||<|0.001|TWO_SIDED|95.0|2.81|15.2|||Regression, Logistic|||||15.20|2.81|<0.001
71724220|NCT02589665|142963972|SUPERIORITY||Odds Ratio (OR)|2.27||||0.054|TWO_SIDED|95.0|0.98|5.22|||Regression, Logistic|||||5.22|0.98|0.054
71724221|NCT02589665|142963973|SUPERIORITY||Odds Ratio (OR)|0.48||||0.131|TWO_SIDED|95.0|0.19|1.24|||Regression, Logistic|||||1.24|0.19|0.131
71724222|NCT02589665|142963974|SUPERIORITY||Odds Ratio (OR)|2.25||||0.215|TWO_SIDED|95.0|0.63|8.07|||Regression, Logistic|||||8.07|0.63|0.215
71724223|NCT02589665|142963974|SUPERIORITY||Odds Ratio (OR)|7.7|||<|0.001|TWO_SIDED|95.0|2.37|25.0|||Regression, Logistic|||||25.00|2.37|<0.001
71724224|NCT02589665|142963974|SUPERIORITY||Odds Ratio (OR)|4.62||||0.012|TWO_SIDED|95.0|1.41|15.14|||Regression, Logistic|||||15.14|1.41|0.012
71724225|NCT02589665|142963975|SUPERIORITY||Odds Ratio (OR)|0.71||||0.428|TWO_SIDED|95.0|0.31|1.65|||Regression, Logistic|||||1.65|0.31|0.428
71724226|NCT01519791|142963990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.283|||<|0.001|TWO_SIDED|95.0|1.503|3.468|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||3.468|1.503|<0.001
71724227|NCT01519791|142963991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957|||<|0.001|TWO_SIDED|95.0|1.384|2.767|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||2.767|1.384|<0.001
71724228|NCT01519791|142963992|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate of shift|-0.978|||<|0.001|TWO_SIDED|95.0|-1.005|-0.5|||ANCOVA on ranks||"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or \>4 months) as factors and rank Baseline value as a covariate.~Confidence Interval is an asymptotic Moses CI."|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.500|-1.005|<0.001
71830200|NCT03351075|143165186|SUPERIORITY||Mean Difference (Net)|0.74||||0.0284|TWO_SIDED|95.0|0.08|1.4|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 4 months||1.40|0.08|0.0284
71830201|NCT03351075|143165186|SUPERIORITY||Mean Difference (Net)|0.09||||0.7776|TWO_SIDED|95.0|-0.55|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1 year||0.73|-0.55|0.7776
71724229|NCT01519791|142963997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446|||=|0.023|TWO_SIDED|95.0|1.052|1.989|||Regression, Logistic||The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||1.989|1.052|=0.023
71830202|NCT03351075|143165186|SUPERIORITY||Mean Difference (Net)|0.31||||0.3829|TWO_SIDED|95.0|-0.39|1.01|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome||Difference in change in wind-up from baseline to 1.5 years||1.01|-0.39|0.3829
71830203|NCT03351075|143165187|SUPERIORITY||Mean Difference (Net)|0.31||||0.1948|TWO_SIDED|95.0|-0.16|0.77|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 4 months||0.77|-0.16|0.1948
71830204|NCT03351075|143165187|SUPERIORITY||Mean Difference (Net)|0.17||||0.4937|TWO_SIDED|95.0|-0.31|0.65|||Multivariate linear model|||Difference in change in conditioned pain modulation from baseline to 1 year||0.65|-0.31|0.4937
71888020|NCT01162421|143296937|SUPERIORITY_OR_OTHER||Difference in percentage|-10.9||||0.283|TWO_SIDED|95.0|-30.84|9.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3||9.01|-30.84|0.283
71888021|NCT01162421|143296937|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.444|TWO_SIDED|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6||28.00|-12.17|0.444
71724230|NCT01519791|142964009|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-0.177|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.273|-0.082|||ANCOVA||The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or \>4 months) as factors and Baseline value as a covariate.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~1. Primary: sustained DAS28(ESR) remission at Week 52~2. Key secondary: sustained DAS28(ESR) LDA at Week 52~3. ACR50 response at Week 52 in relation to Baseline~4. Change from Baseline in HAQ-DI at Week 52~5. Change from Baseline in mTSS at Week 52"||-0.082|-0.273|<0.001
71724231|NCT02226562|142964027|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0001|TWO_SIDED|95.0|-1.28|-0.92||The P-value was less than 0.0001|ANCOVA|ANCOVA with a factor for treatment and baseline as covariate||||-0.92|-1.28|0.0001
71724232|NCT01474772|142964034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.12||0.0659|TWO_SIDED|95.0|-0.46|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints had p-values that were less than 0.05, hence there was no need for multiplicity adjustment.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. Last observation carried forward (LOCF) approach was applied.||0.01|-0.46|0.0659
71724233|NCT01474772|142964035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.128||0.0242|TWO_SIDED|95.0|-0.543|-0.038||Primary analysis was two-sided and performed at the 0.05 significance level. Unstructured covariance structure was used to estimate the within-participant errors.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||This longitudinal analysis was a sensitivity analysis of the primary endpoint. P-value was based on a repeated measure mixed effects model including pooled center, time point, treatment, an indicator variable for Week 6 as well as interaction terms as fixed effect factors. For analysis purpose, it is assumed that participants were on placebo at Baseline, took the same treatment as in Period 1 during Week 1 of washout, and were on placebo in Week 2 of washout.||-0.038|-0.543|0.0242
71724234|NCT01474772|142964036|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.412|TWO_SIDED|95.0|-0.44|0.18||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints have p-values that are less than 0.05, hence there was no need for multiplicity adjustment.|Mixed-Effect Model Repeated Measures|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a repeated measure linear mixed effects model including baseline pain, sequence, period, center, time, treatment, and treatment by time interaction as fixed effect factors and participant within sequence and within-participant error as random factors. The model term 'time' may take 2 values corresponding to Week 3 and Week 6 in each period.||0.18|-0.44|0.4120
71724235|NCT01474772|142964037|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.0847|TWO_SIDED|95.0|0.94|2.55||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.55|0.94|0.0847
71830205|NCT03351075|143165187|SUPERIORITY||Mean Difference (Net)|0.23||||0.369|TWO_SIDED|95.0|-0.27|0.73|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in conditioned pain modulation from baseline to 1.5 years||0.73|-0.27|0.3690
71830206|NCT03351075|143165188|SUPERIORITY||Mean Difference (Net)|2.24||||0.2915|TWO_SIDED|95.0|-1.94|6.43|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 4 months||6.43|-1.94|0.2915
71888022|NCT01162421|143296937|SUPERIORITY_OR_OTHER||Difference in percentage|1.6||||0.885|TWO_SIDED|95.0|-20.16|23.38|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9||23.38|-20.16|0.885
71888023|NCT01162421|143296937|SUPERIORITY_OR_OTHER||Difference in percentage|-1.0||||0.931|TWO_SIDED|95.0|-22.54|20.64|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12||20.64|-22.54|0.931
71724236|NCT01474772|142964038|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2459|TWO_SIDED|95.0|0.8|2.39||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.||2.39|0.80|0.2459
71724237|NCT01474772|142964039|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0889|TWO_SIDED|95.0|-1.71|0.12||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.12|-1.71|0.0889
71724238|NCT01474772|142964040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.86||0.1781|TWO_SIDED|95.0|-2.86|0.53||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.53|-2.86|0.1781
71724239|NCT01474772|142964041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.2719|TWO_SIDED|95.0|-0.53|0.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.15|-0.53|0.2719
71724240|NCT01474772|142964042|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|563.39|STANDARD_ERROR_OF_MEAN|4098.74||0.8909|TWO_SIDED|95.0|-7549.82|8676.6||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||8676.60|-7549.82|0.8909
71769759|NCT02387476|143039548|NON_INFERIORITY|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.36|<|0.001|TWO_SIDED|95.0|-0.4|1.0||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP\<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean ODI values are rounded to a single decimal point value in the text of the table (1.4 and 1.1, respectively) to ensure consistency with ODI reporting standards.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.||1.0|-0.4|<0.001
71769760|NCT01842633|143039583|SUPERIORITY_OR_OTHER||Treatment Difference|-0.47|||||TWO_SIDED|95.0|-1.36|0.42||||||||0.42|-1.36|
71769761|NCT01122394|143039603|SUPERIORITY_OR_OTHER|||||||0.29|||||||robust regression|controlling for provider clustering||Robust regressions were performed||||0.29
71769762|NCT01122394|143039604|SUPERIORITY_OR_OTHER|||||||0.25|||||||Regression, Logistic|This analysis includes participants in pre-action and action/maintenance||||||0.25
71769763|NCT01122394|143039605|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71769764|NCT01122394|143039606|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|||||||0.81
71769765|NCT01122394|143039607|SUPERIORITY_OR_OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
71769766|NCT01555957|143039608|SUPERIORITY|||||||0.94|||||||Chi-squared|||we hypothesized that among ≥ 34 weeks GA infants with GISDs, infants receiving 1g/kg/day S-ILE (lipid minimizing strategy) would have decreased incidence of IFALD compared to those receiving 2g/kg/day S-ILE. We also hypothesized that the rate of rise of DB would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.94
71769767|NCT01555957|143039609|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||We also hypothesized that the rate of rise of direct bilirubin would be lower among ≥ 34 weeks GA infants with GISDs receiving 1g/kg/day versus 2g/kg/day of S-ILE.||||0.0005
71769768|NCT00718081|143039610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.48|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
71769769|NCT00718081|143039610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.62|STANDARD_ERROR_OF_MEAN|4.86|<|0.001|ONE_SIDED|95.0|||||ANCOVA|||||||<0.001
71769770|NCT01931670|143039639|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
71769771|NCT01931670|143039639|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
71769772|NCT01931670|143039640|SUPERIORITY|||||||0.003||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||0.003
71724241|NCT01474772|142964043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|206.37||0.9899|TWO_SIDED|95.0|-411.26|406.01||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||406.01|-411.26|0.9899
71724242|NCT01474772|142964044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.27||0.2854|TWO_SIDED|95.0|-3.88|1.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||1.15|-3.88|0.2854
71724243|NCT01474772|142964045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|1.09||0.1805|TWO_SIDED|95.0|-3.6|0.68||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.68|-3.60|0.1805
71724244|NCT01474772|142964046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.3028|TWO_SIDED|95.0|-0.99|0.31||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.31|-0.99|0.3028
71724245|NCT01474772|142964047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7542|TWO_SIDED|95.0|-0.41|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.30|-0.41|0.7542
71724246|NCT01474772|142964048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.68||0.0634|TWO_SIDED|95.0|-2.62|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-2.62|0.0634
71769773|NCT01931670|143039640|SUPERIORITY||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic|||||||< 0.001
71769774|NCT01931670|143039641|SUPERIORITY||Difference in LS Mean Change|-0.57|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||<0.001
71769775|NCT01931670|143039641|SUPERIORITY||Difference in LS Mean Change|-1.22|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
71769776|NCT01931670|143039642|SUPERIORITY||Difference in LS Mean Change|-0.54|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
71769777|NCT01931670|143039642|SUPERIORITY||Difference in LS Mean Change|-1.13|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
71830207|NCT03351075|143165188|SUPERIORITY||Mean Difference (Net)|-1.63||||0.4632|TWO_SIDED|95.0|-6.02|2.75|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1 year||2.75|-6.02|0.4632
71769778|NCT01931670|143039643|SUPERIORITY||Difference in LS Mean Change|-0.15|STANDARD_ERROR_OF_MEAN|0.056||0.009|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.009
71830208|NCT03351075|143165188|SUPERIORITY||Mean Difference (Net)|-3.16||||0.1944|TWO_SIDED|95.0|-7.94|1.63|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported upper limb function from baseline to 1,5 years||1.63|-7.94|0.1944
71830209|NCT03351075|143165189|SUPERIORITY||Mean Difference (Net)|-293.0||||0.5332|TWO_SIDED|95.0|-1218.0|632.0|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in step count from baseline to 4 months||632|-1218|0.5332
71724247|NCT01474772|142964049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1985|TWO_SIDED|95.0|-0.13|0.62||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.62|-0.13|0.1985
71724248|NCT01474772|142964050|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9686|TWO_SIDED|95.0|-0.21|0.2||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.20|-0.21|0.9686
71769779|NCT01931670|143039643|SUPERIORITY||Difference in LS Mean Change|-0.32|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
71724249|NCT01474772|142964051|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.54||||0.002|TWO_SIDED|95.0|1.3|4.95|||Cochran-Mantel-Haenszel|||Odds ratio is based on the binary response for any improvement while p-value is from the comparison of the original scale of 7 possible outcomes. P-value was calculated by using Cochran Mantel-Haenszel (CMH) test. PGIC values at the end of Period 1 data was compared between treatment groups.||4.95|1.30|0.0020
71724250|NCT01474772|142964052|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.0105|TWO_SIDED|95.0|-0.68|-0.09||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.||-0.09|-0.68|0.0105
71769780|NCT01931670|143039644|SUPERIORITY||Difference in LS Mean Change|-0.05|STANDARD_ERROR_OF_MEAN|0.044||0.26|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.26
71769781|NCT01931670|143039644|SUPERIORITY||Difference in LS Mean Change|-0.18|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
71769782|NCT01931670|143039645|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.088|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.088
71769783|NCT01931670|143039645|SUPERIORITY||Difference in LS Mean Change|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
71769784|NCT01931670|143039646|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.067||0.172|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.172
71830210|NCT03351075|143165189|SUPERIORITY||Mean Difference (Net)|839.0||||0.1201|TWO_SIDED|95.0|-221.0|1900.0|||Multivariate linear model|||Difference in change in step count from baseline to 1 year||1900|-221|0.1201
71888024|NCT01162421|143296937|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18||23.03|-18.63|0.836
71769785|NCT01931670|143039646|SUPERIORITY||Difference in LS Mean Change|-0.3|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||< 0.001
71830211|NCT03351075|143165190|SUPERIORITY||Mean Difference (Net)|0.831||||0.359|TWO_SIDED|95.0|0.561|1.233|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 4 months||1.233|0.561|0.3590
71830212|NCT03351075|143165190|SUPERIORITY||Mean Difference (Net)|0.839||||0.3744|TWO_SIDED|95.0|0.57|1.236|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1 year||1.236|0.570|0.3744
71888025|NCT01162421|143296937|SUPERIORITY_OR_OTHER||Difference in percentage|2.2||||0.836|TWO_SIDED|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24||23.03|-18.63|0.836
71888026|NCT01162421|143296938|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.25||0.699|TWO_SIDED|95.0|-3.6|5.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||5.4|-3.6|0.699
71888027|NCT01162421|143296938|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.45||0.261|TWO_SIDED|95.0|-2.1|7.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||7.7|-2.1|0.261
71724251|NCT01474772|142964053|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1178|TWO_SIDED|95.0|-0.63|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.07|-0.63|0.1178
71724252|NCT01474772|142964054|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.199|TWO_SIDED|95.0|-0.6|0.13||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.13|-0.60|0.1990
71724253|NCT01474772|142964055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.02||0.71107|TWO_SIDED|95.0|-0.025|0.037||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 1997. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.037|-0.025|0.71107
71724254|NCT01474772|142964055|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.02||0.53965|TWO_SIDED|95.0|-0.021|0.039||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 2001. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||0.039|-0.021|0.53965
71724255|NCT02731820|142964060|OTHER|||||||0.172|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.172
71724256|NCT02731820|142964060|OTHER|||||||0.027|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.027
71830213|NCT03351075|143165190|SUPERIORITY||Median Difference (Net)|0.848||||0.4533|TWO_SIDED|95.0|0.522|1.304|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported pain catastrophizing from baseline to 1.5 years||1.304|0.522|0.4533
71830214|NCT03351075|143165191|SUPERIORITY||Mean Difference (Net)|0.862||||0.5018|TWO_SIDED|95.0|0.558|1.33|||MUltivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 4 months||1.330|0.558|0.5018
71830215|NCT03351075|143165191|SUPERIORITY||Mean Difference (Net)|0.808||||0.3362|TWO_SIDED|95.0|0.522|1.248|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1 year||1.248|0.522|0.3362
71830216|NCT03351075|143165191|SUPERIORITY||Mean Difference (Net)|0.958||||0.8375|TWO_SIDED|95.0|0.633|1.449|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported depression from baseline to 1.5 years||1.449|0.633|0.8375
71830217|NCT03351075|143165192|SUPERIORITY||Mean Difference (Net)|-0.32||||0.1745|TWO_SIDED|95.0|-0.78|0.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 4 months||0.14|-0.78|0.1745
71830218|NCT03351075|143165192|SUPERIORITY||Mean Difference (Net)|0.18||||0.5025|TWO_SIDED|95.0|-0.35|0.71|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1 year||0.71|-0.35|0.5025
71724257|NCT02731820|142964060|OTHER|||||||0.053|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.053
71724258|NCT02731820|142964060|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
71830219|NCT03351075|143165192|SUPERIORITY||Mean Difference (Net)|0.45||||0.1363|TWO_SIDED|95.0|-0.14|1.05|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported health-related quality of life from baseline to 1,5 years||1.05|-0.14|0.1363
71724259|NCT02731820|142964060|OTHER|||||||0.006|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.006
71724260|NCT02731820|142964060|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
71724261|NCT02731820|142964060|OTHER|||||||0.967|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.967
71724262|NCT02731820|142964060|OTHER|||||||0.446|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.446
71724263|NCT02731820|142964060|OTHER|||||||0.869|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.869
71830220|NCT03351075|143165193|SUPERIORITY||Percentage|-0.184||||0.074|TWO_SIDED|95.0|-0.358|0.008|||Fisher Exact|||Difference in proportion of working participants at 1 year||0.008|-0.358|0.074
71830221|NCT03351075|143165193|SUPERIORITY||Percentage|-0.09||||0.352|TWO_SIDED|95.0|-0.26|0.078|||Fisher Exact|||Difference in proportion of working participants at 1,5 years||0.078|-0.26|0.352
71888028|NCT01162421|143296938|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.36||0.514|TWO_SIDED|95.0|-6.2|3.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.2|-6.2|0.514
71724264|NCT02731820|142964061|OTHER|||||||0.954|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.954
71724265|NCT02731820|142964061|OTHER|||||||0.798|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.798
71724266|NCT02731820|142964061|OTHER|||||||0.377|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.377
71724267|NCT02731820|142964061|OTHER|||||||0.886|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.886
71724268|NCT02731820|142964061|OTHER|||||||0.04|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.040
71724269|NCT02731820|142964061|OTHER|||||||0.017|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.017
71724270|NCT02731820|142964061|OTHER|||||||0.343|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.343
71724271|NCT02731820|142964061|OTHER|||||||0.859|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.859
71830222|NCT03351075|143165194|SUPERIORITY||Mean Difference (Net)|0.23||||0.8497|TWO_SIDED|95.0|-2.17|2.64|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 4 months||2.64|-2.17|0.8497
71724272|NCT02731820|142964061|OTHER|||||||0.172|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.172
71724273|NCT02731820|142964062|OTHER|||||||0.213|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.213
71724274|NCT02731820|142964062|OTHER|||||||0.191|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.191
71724275|NCT02731820|142964062|OTHER|||||||0.234|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.234
71724276|NCT02731820|142964062|OTHER|||||||0.37|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.370
71724277|NCT02731820|142964062|OTHER|||||||0.176|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0||||0.176
71724278|NCT02731820|142964062|OTHER|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3||||0.139
71724279|NCT02731820|142964062|OTHER|||||||0.551|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.551
71724280|NCT02731820|142964062|OTHER|||||||0.371|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.371
71724281|NCT02731820|142964062|OTHER|||||||0.466|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.466
71724282|NCT02731820|142964063|OTHER|||||||0.094|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0||||0.094
71724283|NCT02731820|142964063|OTHER|||||||0.0004|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||0.0004
71724284|NCT02731820|142964063|OTHER|||||||0.008|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.008
71724285|NCT02731820|142964063|OTHER|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0||||0.002
71724286|NCT02731820|142964063|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0||||<0.0001
71724287|NCT02731820|142964063|OTHER|||||||0.0007|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3||||0.0007
71724288|NCT02731820|142964063|OTHER|||||||0.458|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0||||0.458
71724289|NCT02731820|142964063|OTHER|||||||0.434|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3||||0.434
71724290|NCT02731820|142964063|OTHER|||||||0.555|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6||||0.555
71724291|NCT00967694|142964064|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Mixed Models Analysis|||A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p \< 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25||||>0.05
71724292|NCT00152477|142964066|SUPERIORITY||Difference of response rate|6.4|||=|0.384|TWO_SIDED|95.0|-7.7|20.5||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \<5.|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.384
71724293|NCT00152477|142964066|SUPERIORITY||Difference of response rate|6.4|||=|0.409||95.0|-7.7|20.5||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||20.5|-7.7|=0.409
71724294|NCT00152477|142964066|SUPERIORITY||Difference of response rate|2.6|||=|0.744|TWO_SIDED|95.0|-13.5|18.8||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||18.8|-13.5|=0.744
71724295|NCT00152477|142964066|SUPERIORITY||Difference of response rate|2.6|||=|0.783|TWO_SIDED|95.0|-13.5|18.8||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||18.8|-13.5|=0.783
71724296|NCT00152477|142964066|SUPERIORITY||Difference of response rate|10.2|||=|0.234|TWO_SIDED|95.0|-6.8|27.2||Two-sided Chi-square test. Fisher's Exact test presented when number of responders in a treatment group is \< 5.|Chi-squared|||||27.2|-6.8|=0.234
71724297|NCT00152477|142964066|SUPERIORITY||Difference of response rate|10.2|||=|0.228|TWO_SIDED|95.0|-6.8|27.2||CMH test stratified by country and disease stage (3 levels: Stage IIIb without malignant pleural effusion versus Stage IIIb with malignant pleural effusion or Stage IV or recurrent).|Cochran-Mantel-Haenszel|||||27.2|-6.8|=0.228
71724298|NCT01005316|142964076|SUPERIORITY_OR_OTHER|||||||0.258|||||||Fisher Exact|||The p-value compares Cohort A: Non-Sensitized with Cohort B: Sensitized, Crossmatch Positive.||||0.2580
71724299|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.72|1.05||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.||1.05|0.72|
71724300|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.||1.26|0.84|
71724301|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.||1.10|0.74|
71724302|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.||1.07|0.66|
71724303|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.84|1.2||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.||1.20|0.84|
71724304|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.||1.14|0.78|
71724305|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.78|1.23||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.||1.23|0.78|
71724306|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.52|||||TWO_SIDED|95.0|0.41|0.67||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.||0.67|0.41|
71724307|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|0.86|||||TWO_SIDED|95.0|0.68|1.08||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.||1.08|0.68|
71769786|NCT01931670|143039647|SUPERIORITY||Difference in LS Mean Change|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.968|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.968
71769787|NCT01931670|143039647|SUPERIORITY||Difference in LS Mean Change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.007
71769788|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|2.361|||<|0.001|TWO_SIDED|97.5|1.507|3.697|||Regression, Logistic|||Month 1||3.697|1.507|< 0.001
71769789|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|4.185|||<|0.001|TWO_SIDED|97.5|2.707|6.469|||Regression, Logistic|||Month 1||6.469|2.707|< 0.001
71769790|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|2.795|||<|0.001|TWO_SIDED|97.5|1.811|4.312|||Regression, Logistic|||Month 2||4.312|1.811|< 0.001
71769791|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|10.378|||<|0.001|TWO_SIDED|97.5|6.615|16.282|||Regression, Logistic|||Month 2||16.282|6.615|< 0.001
71657706|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|3.5|45.2|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.2|3.5|
71769792|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|3.178|||<|0.001|TWO_SIDED|97.5|2.084|4.845|||Regression, Logistic|||Month 4||4.845|2.084|< 0.001
71724308|NCT00758264|142964111|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (\>) 0.5.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.||1.38|0.83|
71724309|NCT00758264|142964112|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.93|||||TWO_SIDED|95.0|-1.09|8.15||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).||8.15|-1.09|
71724310|NCT00758264|142964112|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.68|||||TWO_SIDED|95.0|-2.11|6.22||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).||6.22|-2.11|
71724311|NCT00758264|142964112|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.25|||||TWO_SIDED|95.0|-0.94|6.76||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).||6.76|-0.94|
71724312|NCT00758264|142964112|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.18|4.6||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).||4.6|-2.18|
71724313|NCT01467037|142964131|SUPERIORITY_OR_OTHER||Adjusted OR|0.088|||||TWO_SIDED|95.0|0.02|0.384|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.384|0.020|
71724314|NCT01467037|142964131|SUPERIORITY_OR_OTHER||Adjusted OR|0.075|||||TWO_SIDED|95.0|0.018|0.307|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) \*100|||0.307|0.018|
71724315|NCT01194089|142964132|SUPERIORITY_OR_OTHER|||||||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.||||0.828
71724316|NCT01194089|142964132|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.||||0.752
71724317|NCT01194089|142964133|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Chi-squared|||Comparison between the arms for antiemetic medication use in the PACU.||||0.002
71769793|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|15.216|||<|0.001|TWO_SIDED|97.5|9.429|24.554|||Regression, Logistic|||Month 4||24.554|9.429|< 0.001
71888029|NCT01162421|143296938|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|2.5||0.283|TWO_SIDED|95.0|-7.7|2.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||2.3|-7.7|0.283
71724318|NCT01194089|142964134|SUPERIORITY_OR_OTHER|||||||0.354|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score on admission.||||0.354
71724319|NCT01194089|142964134|SUPERIORITY_OR_OTHER|||||||0.492|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 30 minutes.||||0.492
71769794|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|2.548|||<|0.001|TWO_SIDED|97.5|1.683|3.859|||Regression, Logistic|||Month 5||3.859|1.683|< 0.001
71769795|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|14.055|||<|0.001|TWO_SIDED|97.5|8.716|22.664|||Regression, Logistic|||Month 5||22.664|8.716|< 0.001
71769796|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|2.536|||<|0.001|TWO_SIDED|97.5|1.685|3.816|||Regression, Logistic|||Month 6||3.816|1.685|< 0.001
71657707|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
71769797|NCT01931670|143039648|SUPERIORITY||Odds Ratio (OR)|10.106|||<|0.001|TWO_SIDED|97.5|6.434|15.874|||Regression, Logistic|||Month 6||15.874|6.434|< 0.001
71769798|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|1.191||||0.376|TWO_SIDED|97.5|0.765|1.855|||Regression, Logistic|||Month 1||1.855|0.765|0.376
71769799|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|1.376||||0.101|TWO_SIDED|97.5|0.89|2.127|||Regression, Logistic|||Month 1||2.127|0.890|0.101
71888030|NCT01162421|143296938|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.75||0.461|TWO_SIDED|95.0|-7.5|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||3.4|-7.5|0.461
71888031|NCT01162421|143296938|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.703|TWO_SIDED|95.0|-6.6|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-6.6|0.703
71888032|NCT01162421|143296939|SUPERIORITY_OR_OTHER||Difference in percentage|-1.1||||1|TWO_SIDED|95.0|-17.94|15.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 3||15.16|-17.94|1.000
71888033|NCT01162421|143296939|SUPERIORITY_OR_OTHER||Difference in percentage|-6.4||||0.468|TWO_SIDED|95.0|-22.34|8.81|||Fisher Exact|Two-sided Fisher Exact test.||Month 6||8.81|-22.34|0.468
71888034|NCT01162421|143296939|SUPERIORITY_OR_OTHER||Difference in percentage|-11.9||||0.142|TWO_SIDED|95.0|-27.88|3.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 9||3.16|-27.88|0.142
71888035|NCT01162421|143296939|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.712|TWO_SIDED|95.0|-11.08|19.83|||Fisher Exact|Two-sided Fisher Exact test.||Month 12||19.83|-11.08|0.712
71888036|NCT01162421|143296939|SUPERIORITY_OR_OTHER||Difference in percentage|7.2||||0.482|TWO_SIDED|95.0|-8.92|22.89|||Fisher Exact|Two-sided Fisher Exact test.||Month 18||22.89|-8.92|0.482
71888037|NCT01162421|143296939|SUPERIORITY_OR_OTHER||Difference in percentage|-6.2||||0.418|TWO_SIDED|95.0|-21.18|7.69|||Fisher Exact|Two-sided Fisher Exact test.||Month 24||7.69|-21.18|0.418
71724320|NCT01194089|142964134|SUPERIORITY_OR_OTHER|||||||0.809|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 60 minutes.||||0.809
71724321|NCT01194089|142964134|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at discharge.||||0.381
71724322|NCT01626118|142964135|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|317.612|STANDARD_ERROR_OF_MEAN|149.6694||0.034|TWO_SIDED|95.0|23.297|611.926|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||611.926|23.297|0.034
71724323|NCT01626118|142964135|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|342.132|STANDARD_ERROR_OF_MEAN|150.0397||0.023|TWO_SIDED|95.0|47.09|637.175|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||637.175|47.090|0.023
71769800|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|1.358||||0.088|TWO_SIDED|97.5|0.909|2.029|||Regression, Logistic|||Month 2||2.029|0.909|0.088
71769801|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|2.208|||<|0.001|TWO_SIDED|97.5|1.488|3.278|||Regression, Logistic|||Month 2||3.278|1.488|< 0.001
71769802|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|1.678||||0.003|TWO_SIDED|97.5|1.136|2.477|||Regression, Logistic|||Month 4||2.477|1.136|0.003
71769803|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|2.722|||<|0.001|TWO_SIDED|97.5|1.832|4.044|||Regression, Logistic|||Month 4||4.044|1.832|< 0.001
71769804|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|1.537||||0.013|TWO_SIDED|97.5|1.042|2.267|||Regression, Logistic|||Month 5||2.267|1.042|0.013
71769805|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|2.598|||<|0.001|TWO_SIDED|97.5|1.75|3.857|||Regression, Logistic|||Month 5||3.857|1.750|< 0.001
71769806|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|1.565||||0.01|TWO_SIDED|97.5|1.062|2.306|||Regression, Logistic|||Month 6||2.306|1.062|0.01
71769807|NCT01931670|143039649|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|97.5|1.63|3.57|||Regression, Logistic|||Month 6||3.570|1.630|< 0.001
71769808|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.028||||0.901|TWO_SIDED|97.5|0.624|1.693|||Regression, Logistic|||Month 1||1.693|0.624|0.901
71769809|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.103||||0.65|TWO_SIDED|97.5|0.68|1.789|||Regression, Logistic|||Month 1||1.789|0.680|0.65
71769810|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.351||||0.154|TWO_SIDED|97.5|0.841|2.17|||Regression, Logistic|||Month 2||2.170|0.841|0.154
71769811|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.871||||0.003|TWO_SIDED|97.5|1.175|2.979|||Regression, Logistic|||Month 2||2.979|1.175|0.003
71888038|NCT01162421|143296940|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|5.86||0.453|TWO_SIDED|95.0|-16.3|7.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||7.4|-16.3|0.453
71888039|NCT01162421|143296940|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|5.88||0.187|TWO_SIDED|95.0|-19.7|4.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||4.0|-19.7|0.187
71888040|NCT01162421|143296940|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|6.31||0.598|TWO_SIDED|95.0|-16.1|9.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||9.4|-16.1|0.598
71888041|NCT01162421|143296940|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|5.75||0.558|TWO_SIDED|95.0|-8.2|15.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||15.0|-8.2|0.558
71888042|NCT01162421|143296940|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|6.4||0.669|TWO_SIDED|95.0|-10.1|15.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||15.6|-10.1|0.669
71888043|NCT01162421|143296940|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|6.16||0.865|TWO_SIDED|95.0|-11.3|13.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||13.5|-11.3|0.865
71888044|NCT01162421|143296941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.058||0.809|TWO_SIDED|95.0|-0.1|0.13||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||0.13|-0.10|0.809
71724324|NCT01626118|142964135|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|61.972|STANDARD_ERROR_OF_MEAN|150.2717||0.68|TWO_SIDED|95.0|-233.527|357.471|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.||357.471|-233.527|0.680
71724325|NCT01626118|142964135|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|503.008|STANDARD_ERROR_OF_MEAN|102.3149|<|0.001|TWO_SIDED|95.0|301.93|704.086|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||704.086|301.930|<0.001
71724326|NCT01626118|142964135|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|511.357|STANDARD_ERROR_OF_MEAN|102.5851|<|0.001|TWO_SIDED|95.0|309.749|712.965|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||712.965|309.749|<0.001
71724327|NCT01626118|142964135|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|341.232|STANDARD_ERROR_OF_MEAN|102.7761|<|0.001|TWO_SIDED|95.0|139.249|543.215|||Mixed Models Analysis|||"The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than imputing a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter."||543.215|139.249|<0.001
71724328|NCT01626118|142964136|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||||||0.191
71724329|NCT01626118|142964136|SUPERIORITY_OR_OTHER|||||||0.108|||||||t-test, 2 sided|||||||0.108
71724330|NCT01626118|142964136|SUPERIORITY_OR_OTHER|||||||0.461|||||||t-test, 2 sided|||||||0.461
71724331|NCT01626118|142964137|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
71724332|NCT01626118|142964137|SUPERIORITY_OR_OTHER|||||||0.041|||||||t-test, 2 sided|||||||0.041
71724333|NCT01626118|142964137|SUPERIORITY_OR_OTHER|||||||0.458|||||||t-test, 2 sided|||||||0.458
71724334|NCT01626118|142964138|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
71724335|NCT01626118|142964138|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
71724336|NCT01626118|142964138|SUPERIORITY_OR_OTHER|||||||0.441|||||||t-test, 2 sided|||||||0.441
71724337|NCT01626118|142964139|SUPERIORITY_OR_OTHER|||||||0.141|||||||t-test, 2 sided|||||||0.141
71724338|NCT01626118|142964139|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
71724339|NCT01626118|142964139|SUPERIORITY_OR_OTHER|||||||0.716|||||||t-test, 2 sided|||||||0.716
71724340|NCT01626118|142964140|SUPERIORITY_OR_OTHER|||||||0.049|||||||t-test, 2 sided|||||||0.049
71724341|NCT01626118|142964140|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.020
71769812|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.25||||0.294|TWO_SIDED|97.5|0.776|2.013|||Regression, Logistic|||Month 3||2.013|0.776|0.294
71769813|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.865||||0.003|TWO_SIDED|97.5|1.163|2.989|||Regression, Logistic|||Month 3||2.989|1.163|0.003
71769814|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.145||||0.521|TWO_SIDED|97.5|0.713|1.839|||Regression, Logistic|||Month 4||1.839|0.713|0.521
71724342|NCT01626118|142964140|SUPERIORITY_OR_OTHER|||||||0.593|||||||t-test, 2 sided|||||||0.593
71724343|NCT01626118|142964141|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||||||0.021
71724344|NCT01626118|142964141|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||||||0.012
71724345|NCT01626118|142964141|SUPERIORITY_OR_OTHER|||||||0.447|||||||t-test, 2 sided|||||||0.447
71724346|NCT01626118|142964142|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
71724347|NCT01626118|142964142|SUPERIORITY_OR_OTHER|||||||0.017|||||||t-test, 2 sided|||||||0.017
71724348|NCT01626118|142964142|SUPERIORITY_OR_OTHER|||||||0.577|||||||t-test, 2 sided|||||||0.577
71724349|NCT00939029|142964144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.05|TWO_SIDED|90.0|1.0|7.5||1 tailed p-value|Regression, Logistic|||||7.5|1.0|0.05
71724350|NCT00939029|142964145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.014|TWO_SIDED|90.0|1.4|11.6||1 tailed|Regression, Logistic|||||11.6|1.4|0.014
71724351|NCT00939029|142964146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.087|TWO_SIDED|90.0|0.8|6.0||1 tailed|Regression, Logistic|||||6.0|0.8|0.087
71724352|NCT01106651|142964175|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.708|-0.436|||ANCOVA|||||-0.436|-0.708|<0.001
71724353|NCT01106651|142964175|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.841|-0.566|||ANCOVA|||||-0.566|-0.841|<0.001
71724354|NCT01106651|142964176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001||95.0|1.93|4.56|||Regression, Logistic|||||4.56|1.93|<0.001
71724355|NCT01106651|142964176|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001||95.0|2.89|6.95|||Regression, Logistic|||||6.95|2.89|<0.001
71724356|NCT01106651|142964177|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-25.5|STANDARD_ERROR_OF_MEAN|3.147|<|0.001|TWO_SIDED|95.0|-31.68|-19.32|||ANCOVA|||||-19.32|-31.68|<0.001
71724357|NCT01106651|142964177|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-27.7|STANDARD_ERROR_OF_MEAN|3.179|<|0.001|TWO_SIDED|95.0|-33.97|-21.49|||ANCOVA|||||-21.49|-33.97|<0.001
71724358|NCT01106651|142964178|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||ANCOVA|||||-1.7|-2.8|<0.001
71769815|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|2.474|||<|0.001|TWO_SIDED|97.5|1.544|3.963|||Regression, Logistic|||Month 4||3.963|1.544|< 0.001
71769816|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.262||||0.27|TWO_SIDED|97.5|0.787|2.023|||Regression, Logistic|||Month 5||2.023|0.787|0.27
71769817|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|2.416|||<|0.001|TWO_SIDED|97.5|1.5|3.891|||Regression, Logistic|||Month 5||3.891|1.500|< 0.001
71769818|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.013||||0.953|TWO_SIDED|97.5|0.631|1.624|||Regression, Logistic|||Month 6||1.624|0.631|0.953
71769819|NCT01931670|143039650|SUPERIORITY||Odds Ratio (OR)|1.997|||<|0.001|TWO_SIDED|97.5|1.253|3.183|||Regression, Logistic|||Month 6||3.183|1.253|< 0.001
71724359|NCT01106651|142964178|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.4|||ANCOVA|||||-2.4|-3.5|<0.001
71724360|NCT01106651|142964179|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.379|<|0.001|TWO_SIDED|95.0|-2.339|-0.842|||ANCOVA|||||-0.842|-2.339|<0.001
71724361|NCT01106651|142964179|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.371|<|0.001|TWO_SIDED|95.0|-2.833|-1.368|||ANCOVA|||||-1.368|-2.833|<0.001
71724362|NCT01106651|142964180|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.305|<|0.001|TWO_SIDED|95.0|-1.633|-0.428|||ANCOVA|||Region percent total fat||-0.428|-1.633|<0.001
71724363|NCT01106651|142964180|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.772|-0.587|||ANCOVA|||Region percent total fat||-0.587|-1.772|<0.001
71724364|NCT01106651|142964181|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.316||0.001|TWO_SIDED|95.0|-1.677|-0.43|||ANCOVA|||||-0.430|-1.677|0.001
71724365|NCT01106651|142964181|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.311|<|0.001|TWO_SIDED|95.0|-1.812|-0.584|||ANCOVA|||||-0.584|-1.812|<0.001
71724366|NCT01106651|142964182|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.63|STANDARD_ERROR_OF_MEAN|1.134|<|0.001|TWO_SIDED|95.0|-6.854|-2.401|||ANCOVA|||||-2.401|-6.854|<0.001
71769820|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.69|-0.37|||mixed-effects model|||Month 1||-0.37|-0.69|< 0.001
71769821|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.94|-0.62|||mixed-effects model|||Month 1||-0.62|-0.94|< 0.001
71769822|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.6|-0.29|||mixed-effects model|||Month 2||-0.29|-0.6|< 0.001
71888045|NCT01162421|143296941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.062||0.447|TWO_SIDED|95.0|-0.08|0.17||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||0.17|-0.08|0.447
71724367|NCT01106651|142964182|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.147|<|0.001|TWO_SIDED|95.0|-10.14|-5.641|||ANCOVA|||||-5.641|-10.14|<0.001
71724368|NCT01106651|142964183|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.7||0.194|TWO_SIDED|95.0|-12.1|2.5|||ANCOVA|||||2.5|-12.1|0.194
71724369|NCT01106651|142964183|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.846|TWO_SIDED|95.0|-6.6|8.1|||ANCOVA|||||8.1|-6.6|0.846
71724370|NCT01106651|142964184|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.6|7.9|||ANCOVA|||||7.9|2.6|<0.001
71724371|NCT01106651|142964184|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.0|7.4|||ANCOVA|||||7.4|2.0|<0.001
71724372|NCT01106651|142964185|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||||0.8|-0.4|
71724373|NCT01106651|142964185|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||||0.3|-0.9|
71724374|NCT01106651|142964186|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||||0.4|-0.9|
71724375|NCT01106651|142964186|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-1.0|0.3|||ANCOVA|||||0.3|-1.0|
71769823|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.43|-1.12|||mixed-effects model|||Month 2||-1.12|-1.43|< 0.001
71769824|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.68|-0.37|||mixed-effects model|||Month 3||-0.37|-0.68|< 0.001
71724376|NCT01106651|142964187|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.0|||ANCOVA|||||1.0|-0.3|
71724377|NCT01106651|142964187|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|
71724378|NCT01106651|142964188|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||||-0.0|-0.8|
71724379|NCT01106651|142964188|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||||-0.1|-0.9|
71724380|NCT00344318|142964209|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 1 was computed.|Difference in percentage|2.17|||||TWO_SIDED|95.0|-1.51|4.88||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||4.88|-1.51|
71724381|NCT00344318|142964209|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 2 was computed|Difference in percentage|-1.48||||||95.0|-6.05|1.92||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||1.92|-6.05|
71769825|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-1.4|-1.09|||mixed-effects model|||Month 3||-1.09|-1.4|< 0.001
71769826|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.73|-0.42|||mixed-effects model|||Month 4||-0.42|-0.73|< 0.001
71769827|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-1.42|-1.11|||mixed-effects model|||Month 4||-1.11|-1.42|< 0.001
71724382|NCT00344318|142964209|NON_INFERIORITY_OR_EQUIVALENCE|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C after Dose 3 was computed.|Difference in percentage|3.05|||||TWO_SIDED|95.0|-1.02|6.19||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||6.19|-1.02|
71769828|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.65|-0.33|||mixed-effects model|||Month 5||-0.33|-0.65|< 0.001
71769829|NCT01931670|143039651|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-1.42|-1.1|||mixed-effects model|||Month 5||-1.10|-1.42|< 0.001
71769830|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-25.31|STANDARD_ERROR_OF_MEAN|3.669|<|0.001|TWO_SIDED|97.5|-33.55|-17.07|||mixed-effects model|||Month 1||-17.07|-33.55|< 0.001
71769831|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-39.32|STANDARD_ERROR_OF_MEAN|3.657|<|0.001|TWO_SIDED|97.5|-47.53|-31.11|||mixed-effects model|||Month 1||-31.11|-47.53|< 0.001
71724383|NCT00344318|142964209|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix™ minus Prevenar™\] in terms of percentages of subjects reporting rectal fever \>39.0°C across doses was computed.|Difference in percentage|3.13|||||TWO_SIDED|95.0|-2.65|8.01||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever \>39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.||8.01|-2.65|
71724384|NCT03641716|142964270|OTHER||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
71769832|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-21.9|STANDARD_ERROR_OF_MEAN|3.355|<|0.001|TWO_SIDED|97.5|-29.44|-14.36|||mixed-effects model|||Month 2||-14.36|-29.44|< 0.001
71830223|NCT03351075|143165194|SUPERIORITY||Mean Difference (Net)|0.81||||0.4971|TWO_SIDED|95.0|-1.52|3.14|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1 year||3.14|-1.52|0.4971
71830224|NCT03351075|143165194|SUPERIORITY||Mean Difference (Net)|0.45||||0.6831|TWO_SIDED|95.0|-1.72|2.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in cold detection sensitivity from baseline to 1.5 years||2.62|-1.72|0.6831
71830225|NCT03351075|143165195|SUPERIORITY||Mean Difference (Net)|4.78||||0.8584|TWO_SIDED|95.0|-47.72|57.28|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 4 months||57.28|-47.72|0.8584
71830226|NCT03351075|143165195|SUPERIORITY||Mean Difference (Net)|-57.25||||0.0353|TWO_SIDED|95.0|-110.57|-3.93|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1 year||-3.93|-110.57|0.0353
71830227|NCT03351075|143165195|SUPERIORITY||Mean Difference (Net)|-20.1||||0.4865|TWO_SIDED|95.0|-76.72|36.52|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in mechanical pain sensitivity at the arm from baseline to 1.5 years||36.52|-76.72|0.4865
71830228|NCT03351075|143165196|SUPERIORITY||Mean Difference (Net)|1.11||||0.1278|TWO_SIDED|95.0|0.97|1.27|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 4 months||1.27|0.97|0.1278
71657708|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.6|-12.2|
71769833|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-63.31|STANDARD_ERROR_OF_MEAN|3.365|<|0.001|TWO_SIDED|97.5|-70.87|-55.76|||mixed-effects model|||Month 2||-55.76|-70.87|< 0.001
71769834|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-25.15|STANDARD_ERROR_OF_MEAN|3.241|<|0.001|TWO_SIDED|97.5|-32.43|-17.88|||mixed-effects model|||Month 3||-17.88|-32.43|< 0.001
71769835|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-61.94|STANDARD_ERROR_OF_MEAN|3.233|<|0.001|TWO_SIDED|97.5|-69.2|-54.68|||mixed-effects model|||Month 3||-54.68|-69.20|< 0.001
71769836|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-26.97|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|97.5|-34.48|-19.46|||mixed-effects model|||Month 4||-19.46|-34.48|< 0.001
71769837|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-62.37|STANDARD_ERROR_OF_MEAN|3.346|<|0.001|TWO_SIDED|97.5|-69.89|-54.86|||mixed-effects model|||Month 4||-54.86|-69.89|< 0.001
71769838|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-23.36|STANDARD_ERROR_OF_MEAN|3.428|<|0.001|TWO_SIDED|97.5|-31.06|-15.66|||mixed-effects model|||Month 5||-15.66|-31.06|< 0.001
71769839|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-62.9|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|97.5|-70.58|-55.22|||mixed-effects model|||Month 5||-55.22|-70.58|< 0.001
71769840|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-25.89|STANDARD_ERROR_OF_MEAN|3.528|<|0.001|TWO_SIDED|97.5|-33.81|-17.97|||mixed-effects model|||Month 6||-17.97|-33.81|< 0.001
71830229|NCT03351075|143165196|SUPERIORITY||Mean Difference (Net)|1.11||||0.1875|TWO_SIDED|95.0|0.95|1.3|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1 year||1.30|0.95|0.1875
71830230|NCT03351075|143165196|SUPERIORITY||Mean Difference (Net)|1.05||||0.5612|TWO_SIDED|95.0|0.89|1.23|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in pressure pain sensitivity at the pectoral region from baseline to 1.5 years||1.23|0.89|0.5612
71724385|NCT03641716|142964271|OTHER||Effect Size - Cohen's d|-0.01|||||TWO_SIDED|95.0|-0.66|0.65||||||Due to limited size of sub-sample, we calculated a Cohen's d effect size for raw total score on the PSI from baseline to the 3-month follow-up, with a 95% confidence interval.||.65|-.66|
71724386|NCT03641716|142964272|OTHER||||||<|0.01||||||a prior threshold for statistical significance set at p\<.05|t-test, 2 sided|We ran a paired samples t-test with pre/post intervention data (from baseline and 3-month assessments).||After examining the data to ensure it met the statistical assumptions (e.g. normality, no outliers), we ran a paired-sample pre-post t-test to examine the difference in scores from baseline to 3 months on the NutriSTEP (Screening Tool for Every Preschooler) assessment.||||<.01
71830231|NCT03351075|143165197|SUPERIORITY||Mean Difference (Net)|1.089||||0.7902|TWO_SIDED|95.0|0.693|1.62|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 4 months||1.620|0.693|0.7902
71830232|NCT03351075|143165197|SUPERIORITY||Mean Difference (Net)|0.934||||0.7578|TWO_SIDED|95.0|0.604|1.443|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1 year||1.443|0.604|0.7578
71830233|NCT03351075|143165197|SUPERIORITY||Mean Difference (Net)|1.01||||0.96|TWO_SIDED|95.0|0.679|1.504|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported anxiety from baseline to 1.5 years||1.504|0.679|0.9600
71830234|NCT03351075|143165198|SUPERIORITY||Mean Difference (Net)|1.068||||0.7619|TWO_SIDED|95.0|0.696|1.639|||Multivariate linear model|multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 4 months||1.639|0.696|0.7619
71830235|NCT03351075|143165198|SUPERIORITY||Mean Difference (Net)|1.087||||0.7169|TWO_SIDED|95.0|0.702|1.673|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1 year||1.673|0.702|0.7169
71724387|NCT02487654|142964273|SUPERIORITY||||||<|0.05|||||||Log Rank|||||||<0.05
71724388|NCT03268954|142964346|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.557|TWO_SIDED|95.0|0.757|1.238|||Log Rank|P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|||1.238|0.757|=0.557
71724389|NCT03268954|142964347|SUPERIORITY|P-value comparing OS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.|Hazard Ratio (HR)|0.881|||=|0.181|TWO_SIDED|95.0|0.697|1.115|||Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival (OS)||1.115|0.697|=0.181
71724390|NCT03268954|142964352|SUPERIORITY||Hazard Ratio (HR)|1.037|||=|0.562|TWO_SIDED|95.0|0.66|1.63||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS Participants||1.630|0.660|=0.562
71724391|NCT03268954|142964352|SUPERIORITY||Hazard Ratio (HR)|1.512|||=|0.603|TWO_SIDED|95.0|0.068|33.773||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR CMML Participants||33.773|0.068|=0.603
71724392|NCT03268954|142964352|SUPERIORITY||Hazard Ratio (HR)|1.034|||=|0.558|TWO_SIDED|95.0|0.663|1.61||P-value comparing time to AML Transformation between treatment groups was based on 1-sided stratified log-rank test stratified by IPSS-R risk groups of very high, high, or intermediate for HR CMML/MDS.|Log Rank||HR:unadjusted stratified Cox proportional HazardRegression with stratification(IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of AML transformation in combination arm than azacitidine arm.|Time to AML Transformation in HR MDS/CMML Participants||1.610|0.663|=0.558
71830236|NCT03351075|143165198|SUPERIORITY||Mean Difference (Net)|0.987||||0.9535|TWO_SIDED|95.0|0.639|1.525|||Multivariate linear model|A multivariate linear model for longitudinal measures with an unstructured covariance matrix was applied for each continuous outcome.||Difference in change in self-reported stress from baseline to 1.5 years||1.525|0.639|0.9535
71888046|NCT01162421|143296941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.062||0.579|TWO_SIDED|95.0|-0.16|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.09|-0.16|0.579
71724393|NCT03268954|142964353|SUPERIORITY||Absolute Rate Difference|-4.18|||=|0.374|TWO_SIDED|95.0|-13.18|4.83||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants With Complete Remission (CR) and CR+Complete Remission with Incomplete Blood Count Recovery (CRi)||4.83|-13.18|=0.374
71830237|NCT05219253|143165204|SUPERIORITY|The superiority was to be concluded if the lower limit (LL) of the 95% confidence interval (CI) of the adjusted GMC ratio between the HZ/su Group and Placebo Group for anti-gE antibody concentrations was equal to or above (\>=) 3.|GMC Ratio|19.8|||||TWO_SIDED|95.0|14.09|27.82|||ANOVA|||To demonstrate the immunogenicity of HZ/su vaccine compared to Placebo, in terms of anti-gE GMCs, at 1 month post-Dose 2 of study intervention administration (Month 3).||27.82|14.09|
71724394|NCT03268954|142964358|SUPERIORITY||Absolute Rate Difference|-4.67|||=|0.329|TWO_SIDED|95.0|-13.72|4.39||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, Revised International Prognostic Scoring System (IPSS-R) risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR||4.39|-13.72|=0.329
71724395|NCT03268954|142964359|SUPERIORITY||Absolute Rate Difference|-0.44|||=|0.891|TWO_SIDED|95.0|-10.03|9.15||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Number of Participants with OR2||9.15|-10.03|=0.891
71724396|NCT03268954|142964360|SUPERIORITY||Hazard Ratio (HR)|0.679|||=|0.072|TWO_SIDED|95.0|0.402|1.146|||Log Rank|P-value was based on 1-sided log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of CR||1.146|0.402|=0.072
71724397|NCT03268954|142964361|SUPERIORITY||Hazard Ratio (HR)|0.846|||=|0.373|TWO_SIDED|95.0|0.306|2.339||P-value comparing duration of CR+CRi between treatment groups was based on 1-sided unstratified log-rank.|Log Rank||Hazard ratio was based on an unadjusted unstratified Cox proportional hazard regression model with treatment as a factor in the model.|Duration of Complete Remission + Complete Remission with Incomplete Blood Count Recovery (CRi)||2.339|0.306|=0.373
71724398|NCT03268954|142964362|SUPERIORITY||Hazard Ratio (HR)|0.889|||=|0.32|TWO_SIDED|95.0|0.542|1.458||P-value comparing duration of PR or better response between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response (OR)||1.458|0.542|=0.320
71888047|NCT01162421|143296941|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.057||0.922|TWO_SIDED|95.0|-0.11|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.12|-0.11|0.922
71724399|NCT03268954|142964363|SUPERIORITY||Hazard Ratio (HR)|0.796|||=|0.151|TWO_SIDED|95.0|0.514|1.231||P-value comparing duration of overall response 2 between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Duration of Overall Response 2 (OR2)||1.231|0.514|=0.151
71724400|NCT03268954|142964364|SUPERIORITY||Absolute Rate Difference|3.27|||=|0.573|TWO_SIDED|95.0|-9.02|15.55||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBC-transfusion Independence||15.55|-9.02|=0.573
71724401|NCT03268954|142964364|SUPERIORITY||Absolute Rate Difference|-3.43|||=|0.477|TWO_SIDED|95.0|-25.84|18.97||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||18.97|-25.84|=0.477
71724402|NCT03268954|142964365|SUPERIORITY||Hazard Ratio (HR)|1.231|||=|0.774|TWO_SIDED|95.0|0.715|2.119||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of RBC Transfusion Independence||2.119|0.715|=0.774
71724403|NCT03268954|142964365|SUPERIORITY||Hazard Ratio (HR)|1.533|||=|0.801|TWO_SIDED|95.0|0.567|4.147||P-value comparing duration of platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Platelet Transfusion Independence||4.147|0.567|=0.801
71724404|NCT03268954|142964365|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.45|TWO_SIDED|95.0|0.58|1.614||P-value comparing duration of RBC or platelet transfusion between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.|Duration of Transfusion Independence||1.614|0.580|=0.450
71724405|NCT03268954|142964366|SUPERIORITY||Hazard Ratio (HR)|0.88|||=|0.228|TWO_SIDED|95.0|0.628|1.234||P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified log-rank test stratified by low-blast AML,IPSS-R risk groups of very high,high,or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.|Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)||1.234|0.628|=0.228
71724406|NCT03268954|142964367|SUPERIORITY||Absolute Rate Difference|-5.46|||=|0.32|TWO_SIDED|95.0|-16.36|5.44||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Number of Participants With HI||5.44|-16.36|=0.320
71724407|NCT03268954|142964368|SUPERIORITY||Rate Difference|2.64|||||TWO_SIDED|95.0|-0.3|5.58||||||Number of Participants With at Least 1 Inpatient Hospital Admissions Related to HR MDS, CMML or Low-blast AML||5.58|-0.30|
71657709|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71769841|NCT01931670|143039652|SUPERIORITY||LS Mean of Difference|-56.62|STANDARD_ERROR_OF_MEAN|3.522|<|0.001|TWO_SIDED|97.5|-64.53|-48.7|||mixed-effects model|||Month 6||-48.70|-64.53|< 0.001
71769842|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.549|TWO_SIDED|97.5|-0.11|0.07|||mixed-effects model|||Month 1||0.07|-0.11|0.549
71769843|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.02
71769844|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.11|TWO_SIDED|97.5|-0.17|0.03|||mixed-effects model|||Month 2||0.03|-0.17|0.11
71724408|NCT03268954|142964369|SUPERIORITY||Hazard Ratio (HR)|0.858|||=|0.084|TWO_SIDED|95.0|0.689|1.067||P-value was obtained from a stratified 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||Hazard ratio was based on a stratified Cox proportional hazard regression model stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML, with treatment as a factor in the model.|Time to Progressive Disease (PD), Relapse after CR (Low-blast AML), Relapse After CR or PR (HR MDS/CMML), or Death||1.067|0.689|=0.084
71724409|NCT03268954|142964370|SUPERIORITY||Hazard Ratio (HR)|0.75|||=|0.002|TWO_SIDED|95.0|0.615|0.913|||Log Rank|||||0.913|0.615|=0.002
71724410|NCT03268954|142964372|SUPERIORITY||Absolute Rate Difference|-2.85|||=|0.683|TWO_SIDED|95.0|-19.44|13.75||P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel|||OR: HR MDS/CMML Participants||13.75|-19.44|=0.683
71769845|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|97.5|-0.3|-0.11|||mixed-effects model|||Month 2||-0.11|-0.30|< 0.001
71769846|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.041|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||Month 3||0.01|-0.22|0.041
71769847|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||Month 3||-0.18|-0.41|< 0.001
71830238|NCT03086369|143165216|SUPERIORITY||Hazard Ratio (HR)|1.054||||0.7902|TWO_SIDED|95.0|0.728|1.527|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.527|0.728|0.7902
71724411|NCT03268954|142964372|SUPERIORITY||Absolute Rate Difference|2.36|||=|0.84|TWO_SIDED|95.0|-20.39|25.12||P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||ORR: Low-blast AML Participants||25.12|-20.39|=0.840
71724412|NCT03268954|142964373|SUPERIORITY||Hazard Ratio (HR)|0.877|||=|0.24|TWO_SIDED|95.0|0.608|1.263||P-value comparing EFS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.263|0.608|=0.240
71769848|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.052||0.081|TWO_SIDED|97.5|-0.21|0.03|||mixed-effects model|||Month 4||0.03|-0.21|0.081
71769849|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|97.5|-0.45|-0.22|||mixed-effects model|||Month 4||-0.22|-0.45|<0.001
71769850|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.062|TWO_SIDED|97.5|-0.22|0.02|||mixed-effects model|||Month 5||0.02|-0.22|0.062
71769851|NCT01931670|143039653|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.46|-0.22|||mixed-effects model|||Month 5||-0.22|-0.46|< 0.001
71769852|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-3.04|STANDARD_ERROR_OF_MEAN|2.94||0.301|TWO_SIDED|97.5|-9.64|3.56|||mixed-effects model|||Month 1||3.56|-9.64|0.301
71769853|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-6.43|STANDARD_ERROR_OF_MEAN|2.92||0.028|TWO_SIDED|97.5|-12.99|0.13|||mixed-effects model|||Month 1||0.13|-12.99|0.028
71769854|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-5.17|STANDARD_ERROR_OF_MEAN|2.964||0.082|TWO_SIDED|97.5|-11.82|1.49|||mixed-effects model|||Month 2||1.49|-11.82|0.082
71769855|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.956|<|0.001|TWO_SIDED|97.5|-19.83|-6.55|||mixed-effects model|||Month 2||-6.55|-19.83|< 0.001
71769856|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-6.84|STANDARD_ERROR_OF_MEAN|3.379||0.043|TWO_SIDED|97.5|-14.43|0.75|||mixed-effects model|||Month 3||0.75|-14.43|0.043
71769857|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-19.05|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|97.5|-26.61|-11.49|||mixed-effects model|||Month 3||-11.49|-26.61|< 0.001
71769858|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-6.25|STANDARD_ERROR_OF_MEAN|3.473||0.072|TWO_SIDED|97.5|-14.05|1.55|||mixed-effects model|||Month 4||1.55|-14.05|0.072
71769859|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-21.58|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|97.5|-29.35|-13.81|||mixed-effects model|||Month 4||-13.81|-29.35|< 0.001
71769860|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-6.21|STANDARD_ERROR_OF_MEAN|3.536||0.08|TWO_SIDED|97.5|-14.15|1.73|||mixed-effects model|||Month 5||1.73|-14.15|0.08
71769861|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-21.66|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|97.5|-29.56|-13.75|||mixed-effects model|||Month 5||-13.75|-29.56|< 0.001
71769862|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-10.83|STANDARD_ERROR_OF_MEAN|3.744||0.004|TWO_SIDED|97.5|-19.24|-2.43|||mixed-effects model|||Month 6||-2.43|-19.24|0.004
71830239|NCT03086369|143165220|SUPERIORITY||Hazard Ratio (HR)|1.192||||0.3771|TWO_SIDED|95.0|0.806|1.764|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|||1.764|0.806|0.3771
71830240|NCT03086369|143165223|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.017|TWO_SIDED|95.0|0.175|0.872|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).||||0.872|0.175|0.017
71724413|NCT03268954|142964374|SUPERIORITY||Hazard Ratio (HR)|0.826|||=|0.145|TWO_SIDED|95.0|0.58|1.178||P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.|Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group||1.178|0.580|=0.145
71724414|NCT03268954|142964375|SUPERIORITY||Absolute Rate Difference|-5.14|||=|0.261|TWO_SIDED|95.0|-13.95|3.68||P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.|Cochran-Mantel-Haenszel|||Overall Response for HR MDS/CMML||3.68|-13.95|=0.261
71724415|NCT03268954|142964375|SUPERIORITY||Absolute Rate Difference|22.36|||=|0.026|TWO_SIDED|95.0|3.22|41.49||P-value was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Overall Response for Low-blast AML||41.49|3.22|=0.026
71724416|NCT03802630|142964376|NON_INFERIORITY|Non-inferiority was considered established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is greater than -4 letters.|Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.01||0.018|TWO_SIDED|95.0|-3.9|0.1|||ANOVA|||||0.1|-3.9|0.018
71724417|NCT04091581|142964407|OTHER|||||||0.002|||||||ANOVA|||||||0.002
71724418|NCT04091581|142964407|OTHER|||||||0.022|||||||t-test, 2 sided|||Comparison of the baseline tear evaporation rate of the non-dry eye and dry eye group.||||0.022
71724419|NCT03724981|142964414|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
71724420|NCT03724981|142964415|SUPERIORITY||||||<|0.0001|||||||Prescott test|||||||<0.0001
71830241|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|0.718||||0.288|TWO_SIDED|95.0|0.392|1.317|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Appetite loss||1.317|0.392|0.288
71724421|NCT01843673|142964478|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
71724422|NCT01843673|142964478|NON_INFERIORITY_OR_EQUIVALENCE|Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.||||1.00
71724423|NCT01074463|142964514|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|109.18|||||TWO_SIDED|90.0|99.25|120.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||120.12|99.25|
71830242|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|0.788||||0.442|TWO_SIDED|95.0|0.423|1.468|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Constipation||1.468|0.423|0.442
71830243|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.883|TWO_SIDED|95.0|0.612|1.755|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Diarrhoea||1.755|0.612|0.883
71830244|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.803|TWO_SIDED|95.0|0.532|1.636|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Dyspnoea||1.636|0.532|0.803
71830245|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|1.053||||0.805|TWO_SIDED|95.0|0.675|1.645|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Fatigue||1.645|0.675|0.805
71830246|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.465|TWO_SIDED|95.0|0.42|1.464|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Financial difficulties||1.464|0.420|0.465
71724424|NCT01074463|142964515|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.06|||||TWO_SIDED|90.0|98.73|109.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.68|98.73|
71830247|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|1.457||||0.231|TWO_SIDED|95.0|0.787|2.698|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Insomnia||2.698|0.787|0.231
71888048|NCT01162421|143296941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.064||0.894|TWO_SIDED|95.0|-0.14|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.12|-0.14|0.894
71724425|NCT01074463|142964516|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.34|||||TWO_SIDED|90.0|97.78|107.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.11|97.78|
71724426|NCT01734395|142964517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|4.56|<|0.0001|TWO_SIDED|95.0|-1.4262|-0.9467|||t-test, 2 sided|||||-0.9467|-1.4262|<.0001
71724427|NCT01734395|142964518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|10.69|<|0.0001|TWO_SIDED|95.0|0.9188|2.0438|||t-test, 2 sided|||||2.0438|0.9188|<.0001
71724428|NCT01734395|142964519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|2.43|<|0.0001|TWO_SIDED|95.0|-0.814|-0.5586|||t-test, 2 sided|||||-0.5586|-0.814|<.0001
71724429|NCT02300558|142964548|OTHER|||||||0.0087|||||||paired t- test|||Based on a 2-sided, paired t-test ( α = 0.05), and a standard deviation (SD) of 30 msec, a sample size of 40 participants provided greater than 95% power assuming a difference in mean daytime QTcF interval (AUC0-6/6) as measured by standard 12-lead ECG between baseline and Week 24 of 20 msec. The null hypothesis was that the mean difference between the baseline and Week 24 mean daytime QTcF interval was zero.||||0.0087
71724430|NCT03888235|142964563|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in Oswestry low back pain and disability score improvement between the three treatment groups.||||0.003
71724431|NCT03888235|142964563|SUPERIORITY|||||||0.001||||||SI Exercise versus usual care. Bonferroni alpha correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||||||0.001
71724432|NCT03888235|142964563|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in Oswestry low back pain and disability score between those using a pelvic support belt and those using usual treatment||||0.314
71724433|NCT03888235|142964564|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||Oswestry low back pain and disability (ODI) score change over two months for all participants. This compares the score at initial visit and the score 2 months later after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. =(ODI time 0 - ODI 2 months). The greater the difference, the better the recovery of back function.||||< 0.001
71724434|NCT03888235|142964565|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||The null hypothesis assumes that after one month, there is no difference in brief pain inventory score improvement between the three treatment groups.||||0.17
71724435|NCT03888235|142964565|SUPERIORITY|||||||0.089||||||Bonferroni alpha correction of p\<0.0167.|Wilcoxon (Mann-Whitney)|||The brief pain inventory score at the one month visit, is used to compare the pain levels of those having done one month of corrective exercises to those who continued with conventional treatments for their low back pain.||||0.089
71724436|NCT03888235|142964565|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||The brief pain inventory score is used to compare those using a pelvic support belt for one month and those with delayed treatment||||0.092
71724437|NCT03888235|142964566|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||All participants are assessed as a single group as they receive the same two treatments for one month. Brief pain inventory (BPI) score change over two months for all participants. This compares BPI score at baseline visit and BPI score 2 months later, after all participants have been using the corrective exercise and sacroiliac stabilization belt for one month. The score is between 0 and 10. The higher the change in score the greater the pain relief.||||< 0.001
71724438|NCT03888235|142964567|SUPERIORITY|||||||0.016||||||The Bonferroni alpha correction is used p\<0.0167|Kruskal-Wallis|||The null hypothesis assumes there is no improvement after one month in posterior superior iliac spine levels (PSISL) measured using the sacroiliac forward flexion test (SIFFT) between the three treatment groups.||||0.016
71724439|NCT03888235|142964567|SUPERIORITY|||||||0.009||||||The Bonferroni alpha correction is used p\<0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the distance between the posterior sacroiliac spine levels (PSISL) between those who use their usual low back pain treatments and those who are given the corrective exercises (SIFFTE) and use them as needed for one month.||||0.009
71724440|NCT03888235|142964567|SUPERIORITY|||||||0.034||||||Bonferroni correction p\< 0.0167|Wilcoxon (Mann-Whitney)|||The null hypothesis is that that using a pelvic support belt will not help correct sacroiliac joint asymmetry as measured using the distance between the posterior superior iliac spine levels (PSISL), baseline and one month later better than conventional treatment for low back pain.||||0.034
71724441|NCT03888235|142964568|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Since all participants have received the same 2 treatment for one month, we will treat them as a single group. We will measure the distance between their posterior superior iliac spine levels (PSISL) when they enter the study and two months later after they have used the corrective exercise and the sacroiliac belt for one month. Corona prevented some participants from returning for examination, which this test requires. Only 11 participants were present in each group: 33 participants tested.||||< 0.0001
71724442|NCT03888235|142964568|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||< 0.001
71724443|NCT03888235|142964569|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the physiotherapy as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
71830248|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|0.914||||0.748|TWO_SIDED|95.0|0.532|1.57|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Nausea and vomiting||1.570|0.532|0.748
71724444|NCT03888235|142964570|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the acupuncture as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
71724445|NCT03888235|142964571|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with the yoga exercises as they were with using the corrective exercises and the pelvic stabilization belt||||<0.00001
71657710|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71724446|NCT03888235|142964572|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with the core exercises as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
71724447|NCT03888235|142964573|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||the null hypothesis is that all participants were as satisfied with treatments by a chiropractor as they were with using the corrective exercise and the pelvic stabilization belt||||<0.00001
71724448|NCT03888235|142964574|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||The null hypothesis is that all participants were as satisfied with massage therapy as they were with using the corrective exercise and the pelvic stabilization belt.||||<0.00001
71724449|NCT00712725|142964610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71724450|NCT00712725|142964611|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71724451|NCT00712725|142964612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71724452|NCT00712725|142964613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71724453|NCT00712725|142964614|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||0.007
71724454|NCT00712725|142964615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.||||||<0.001
71724455|NCT03709277|142964619|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71724456|NCT03709277|142964620|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71724457|NCT03709277|142964622|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71724458|NCT05248997|142964637|SUPERIORITY||Difference in least square mean|-0.09||||0.7782|TWO_SIDED|95.0|-0.71|0.53||LM included baseline value as covariate,\& fixed effects for treatment group,stratification factor,scheduled time point(TP),TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.53|-0.71|0.7782
71724459|NCT05248997|142964638|SUPERIORITY||Difference in least square mean|-0.29||||0.7079|TWO_SIDED|95.0|-1.83|1.24||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||1.24|-1.83|0.7079
71724460|NCT05248997|142964639|SUPERIORITY||Difference in least square mean|-0.23||||0.4398|TWO_SIDED|95.0|-0.81|0.36||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.36|-0.81|0.4398
71724461|NCT05248997|142964640|SUPERIORITY||Difference in least square mean|0.04||||0.889|TWO_SIDED|95.0|-0.51|0.59||LM included baseline value as covariate, and fixed effects for treatment group,stratification factor,scheduled TP, TP by treatment group interaction.Repeated measures:modelled by unstructured covariance structure for within participant error.|Linear model (LM)|||||0.59|-0.51|0.8890
71724462|NCT05248997|142964641|SUPERIORITY||Percentage difference|3.8||||0.6412|TWO_SIDED|95.0|-12.1|19.7|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||19.7|-12.1|0.6412
71724463|NCT05248997|142964642|SUPERIORITY||Percentage difference|-2.7||||0.5001|TWO_SIDED|95.0|-10.6|5.2|||Mantel-Haenszel|Stratified by presence of nasal polyps at randomization with Mantel-Haenszel risk estimation.||||5.2|-10.6|0.5001
71830249|NCT03086369|143165224|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.875|TWO_SIDED|95.0|0.491|1.827|||Log Rank|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Stratified by age group (\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).|Pain||1.827|0.491|0.875
71724464|NCT01453205|142964643|SUPERIORITY_OR_OTHER|||||||0.5543|||||||Cochran-Mantel-Haenszel|||||||0.5543
71724465|NCT01453205|142964644|SUPERIORITY_OR_OTHER|||||||0.8567|||||||Log Rank|||||||0.8567
71724466|NCT01453205|142964645|SUPERIORITY_OR_OTHER|||||||0.7412|||||||Log Rank|||||||0.7412
71724467|NCT01453205|142964646|SUPERIORITY_OR_OTHER|||||||0.9996|||||||Log Rank|||||||0.9996
71724468|NCT01453205|142964647|SUPERIORITY_OR_OTHER|||||||0.1686|||||||Log Rank|||||||0.1686
71724469|NCT02602275|142964683|SUPERIORITY|||||||0.004||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||0.004
71724470|NCT02602275|142964684|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
71657711|NCT02504671|142831745|OTHER||Difference|32.4|||||TWO_SIDED|95.0|12.4|52.4|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||52.4|12.4|
71724471|NCT02602275|142964685|SUPERIORITY||||||<|0.001||||||Significance level was 0.05.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but the preceding endpoint was not met.||||||<0.001
71724472|NCT02602275|142964686|SUPERIORITY||||||>|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the Automated Anatomical Labelling Atlas (AAL) coordinates.|Paired t-test|||||||>0.05
71724473|NCT02602275|142964687|SUPERIORITY||||||<|0.05||||||Significance level is 0.05, corrected for multiple comparisons in the search volume which is anatomically defined by the AAL (Automated Anatomical Labelling Atlas) coordinates.|Paired t-test|The outcome was deemed exploratory, as multiplicity was controlled using a priori ordered hypotheses, but a preceding endpoint was not met.||||||<0.05
71724474|NCT04262882|142964688|SUPERIORITY||Odds Ratio (OR)|1.67||||0.2|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|Adjusted for age and religion. Analysis in GEE to account for dependence in repeated, dyadic data.|Reference group is the comparator arm|||3.64|0.77|0.20
71724475|NCT04262882|142964691|SUPERIORITY||Wald Chi-Square|35.2|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.|||||<0.001
71724476|NCT04262882|142964691|SUPERIORITY||unstandardized beta|0.41|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724477|NCT04262882|142964691|SUPERIORITY||unstandardized beta|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724478|NCT04262882|142964692|SUPERIORITY||Wald Chi-Square|64.53|||<|0.001|TWO_SIDED|||||Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints.||"Tests of significance for each follow-up time point:~7-months: unstandardized beta=1.08, standard error=0.14, p \< 0.001; 10-months: unstandardized beta=0.79, standard error=0.14, p \< 0.001"|||<0.001
71724479|NCT04262882|142964692|SUPERIORITY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724480|NCT04262882|142964692|SUPERIORITY||unstandardized beta|0.79|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724481|NCT04262882|142964693|SUPERIORITY||Wald Chi-Square|23.89|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724482|NCT04262882|142964693|SUPERIORITY||unstandardized beta|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71769863|NCT01931670|143039654|SUPERIORITY||LS Mean of Difference|-21.16|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-29.54|-12.79|||mixed-effects model|||Month 6||-12.79|-29.54|< 0.001
71724483|NCT04262882|142964693|SUPERIORITY||unstandardized beta|0.19|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724484|NCT04262882|142964694|SUPERIORITY||Wald Chi-Square|48.26|||<|0.001|TWO_SIDED||||||Regression, Linear|Models control for age and religion. Models were run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724485|NCT04262882|142964694|SUPERIORITY||unstandardized beta|0.68|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Cox|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71657712|NCT02504671|142831745|OTHER||Difference|35.1|||||TWO_SIDED|95.0|15.1|55.1|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||55.1|15.1|
71769864|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|0.02|STANDARD_ERROR_OF_MEAN|0.059||0.688|TWO_SIDED|97.5|-0.11|0.16|||mixed-effects model|||Month 1||0.16|-0.11|0.688
71769865|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.431|TWO_SIDED|97.5|-0.18|0.08|||mixed-effects model|||Month 1||0.08|-0.18|0.431
71657713|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
71657714|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657715|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71724486|NCT04262882|142964694|SUPERIORITY||unstandardized beta|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.04
71724487|NCT04262882|142964695|SUPERIORITY||Wald Chi-Square|9.87||||0.007|TWO_SIDED|||||Arm\*Time p value for 10-months follow up overall.|Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.007
71724488|NCT04262882|142964695|SUPERIORITY|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.|unstandardized beta|-0.16|STANDARD_ERROR_OF_MEAN|0.32||0.6|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|||||||0.60
71769866|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.277|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||Month 2||0.07|-0.20|0.277
71769867|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|97.5|-0.37|-0.1|||mixed-effects model|||Month 2||-0.10|-0.37|< 0.001
71769868|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.071||0.494|TWO_SIDED|97.5|-0.21|0.11|||mixed-effects model|||Month 4||0.11|-0.21|0.494
71769869|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.43|-0.11|||mixed-effects model|||Month 4||-0.11|-0.43|< 0.001
71769870|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.765|TWO_SIDED|97.5|-0.18|0.14|||mixed-effects model|||Month 5||0.14|-0.18|0.765
71769871|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.073|<|0.001|TWO_SIDED|97.5|-0.47|-0.15|||mixed-effects model|||Month 5||-0.15|-0.47|< 0.001
71724489|NCT04262882|142964695|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
71724490|NCT04262882|142964696|SUPERIORITY||Wald Chi-Square|10.42||||0.005|TWO_SIDED||||||Regression, Logistic|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.005
71769872|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_DEVIATION|0.076||0.468|TWO_SIDED|97.5|-0.23|0.12|||mixed-effects model|||Month 6||0.12|-0.23|0.468
71769873|NCT01931670|143039655|SUPERIORITY||LS Mean of Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.5|-0.16|||mixed-effects model|||Month 6||-0.16|-0.50|< 0.001
71724491|NCT04262882|142964696|SUPERIORITY||Odds Ratio (OR)|1.36||||0.05|TWO_SIDED|95.0|0.99|1.85||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.85|0.99|0.05
71769874|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.029|TWO_SIDED|97.5|-0.18|0.0|||mixed-effects model|||Month 1||0.00|-0.18|0.029
71769875|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|97.5|-0.2|-0.03|||mixed-effects model|||Month 1||-0.03|-0.20|0.004
71830250|NCT04603924|143165238|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement will be assumed to be \> 2 (i.e., no hospital discharge). Median time-to-clinical improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves. In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
71724492|NCT04262882|142964696|SUPERIORITY||Odds Ratio (OR)|0.96||||0.71|TWO_SIDED|95.0|0.75|1.22||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Logistic|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||1.22|0.75|0.71
71769876|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.042||0.076|TWO_SIDED|97.5|-0.17|0.02|||mixed-effects model|||Month 2||0.02|-0.17|0.076
71769877|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|97.5|-0.28|-0.09|||mixed-effects model|||Month 2||-0.09|-0.28|< 0.001
71769878|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.058|TWO_SIDED|97.5|-0.19|0.02|||mixed-effects model|||Month 4||0.02|-0.19|0.058
71769879|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.32|-0.12|||mixed-effects model|||Month 4||-0.12|-0.32|< 0.001
71769880|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.284|TWO_SIDED|97.5|-0.16|0.06|||mixed-effects model|||Month 5||0.06|-0.16|0.284
71769881|NCT01931670|143039656|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|97.5|-0.33|-0.11|||mixed-effects model|||Month 5||-0.11|-0.33|< 0.001
71769882|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.56|-0.18|||ANOVA|||Month 1||-0.18|-0.56|< 0.001
71769883|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.84|-0.46|||ANOVA|||Month 1||-0.46|-0.84|< 0.001
71769884|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-0.82|-0.42|||ANOVA|||Month 2||-0.42|-0.82|< 0.001
71769885|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.29|-0.89|||ANOVA|||Month 2||-0.89|-1.29|< 0.001
71769886|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.84|-0.42|||ANOVA|||Month 3||-0.42|-0.84|< 0.001
71769887|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-1.35|-0.93|||ANOVA|||Month 3||-0.93|-1.35|< 0.001
71769888|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-0.84|-0.41|||ANOVA|||Month 4||-0.41|-0.84|< 0.001
71724493|NCT04262882|142964697|SUPERIORITY||Wald Chi-Square|13.4||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
71724494|NCT04262882|142964697|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.07
71724495|NCT04262882|142964697|SUPERIORITY||unstandardized beta|0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724496|NCT04262882|142964698|SUPERIORITY||Wald Chi-Square|78.81||||0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
71724497|NCT04262882|142964698|SUPERIORITY||unstandardized beta|1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724498|NCT04262882|142964698|SUPERIORITY||unstandardized beta|1.65|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.001
71724499|NCT04262882|142964699|SUPERIORITY||Wald Chi-Square|19.46|||<|0.001|TWO_SIDED||||||Regression, Linear|Model controls for age and religion. Model was run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724500|NCT04262882|142964699|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 7-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||0.008
71724501|NCT04262882|142964699|SUPERIORITY||unstandardized beta|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 10-month follow-up|Regression, Linear|Models control for age and religion. Models run using generalized estimating equations (GEE) to account for dependence in repeated, dyadic data.||||||<0.001
71724502|NCT02333396|142964709|SUPERIORITY||Beta Estimate|3.57|STANDARD_ERROR_OF_MEAN|4.53||0.44|TWO_SIDED|95.0|-5.77|12.9|||Mixed Models Analysis|||||12.9|-5.77|0.44
71724503|NCT02333396|142964710|SUPERIORITY||Beta Estimate|3.62|STANDARD_ERROR_OF_MEAN|2.05||0.09|TWO_SIDED|95.0|-0.61|7.84|||Mixed Models Analysis|||||7.84|-0.61|0.09
71724504|NCT02333396|142964711|SUPERIORITY||Beta Estimate|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.05|TWO_SIDED|95.0|-0.09|8.36|||Mixed Models Analysis|||||8.36|-0.09|0.05
71724505|NCT02333396|142964712|SUPERIORITY||Beta Estimare|3.02|STANDARD_ERROR_OF_MEAN|2.26||0.19|TWO_SIDED|95.0|-1.63|7.67|||Mixed Models Analysis|||||7.67|-1.63|0.19
71724506|NCT02333396|142964713|SUPERIORITY||Beta Estimate|-0.22|STANDARD_ERROR_OF_MEAN|2.47||0.93|TWO_SIDED|95.0|-5.33|4.88|||Mixed Models Analysis|||||4.88|-5.33|0.93
71724507|NCT02333396|142964714|SUPERIORITY||Beta Estimate|-0.35|STANDARD_ERROR_OF_MEAN|1.29||0.79|TWO_SIDED|95.0|-3.02|2.31|||Mixed Models Analysis|||||2.31|-3.02|0.79
71724508|NCT02333396|142964717|SUPERIORITY||Beta Estimate|0.49|STANDARD_ERROR_OF_MEAN|1.03||0.64|TWO_SIDED|95.0|-2.62|1.64|||Mixed Models Analysis|||||1.64|-2.62|0.64
71724509|NCT02333396|142964718|SUPERIORITY||Beta Estimate|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.39|TWO_SIDED|95.0|-3.02|1.22|||Mixed Models Analysis|||||1.22|-3.02|0.39
71724510|NCT02333396|142964720|SUPERIORITY||Beta Estiamte|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
71724511|NCT02333396|142964721|SUPERIORITY||Beta Estimate|1.72|STANDARD_ERROR_OF_MEAN|1.1||0.13|TWO_SIDED|95.0|-0.55|3.98|||Mixed Models Analysis|||||3.98|-0.55|0.13
71724512|NCT01108731|142964723|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
71724513|NCT01108731|142964724|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||General Linear Model (GLM)|||||||<0.05
71724514|NCT01108731|142964725|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71724515|NCT01892722|142964726|SUPERIORITY||||||<|0.001|||||||Negative binomial regression model|||||||<0.001
71724516|NCT01252186|142964733|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|-11.54||||0.958|TWO_SIDED|95.0|-440.1|417.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||417.0|-440.1|0.958
71769889|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.43|-1.0|||ANOVA|||Month 4||-1.00|-1.43|< 0.001
71769890|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.01|-0.57|||ANOVA|||Month 5||-0.57|-1.01|< 0.001
71769891|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.113|<|0.001|TWO_SIDED|95.0|-1.47|-1.02|||ANOVA|||Month 5||-1.02|-1.47|< 0.001
71769892|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.95|-0.49|||ANOVA|||Month 6||-0.49|-0.95|< 0.001
71769893|NCT01931670|143039657|SUPERIORITY||LS Mean of Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.5|-1.04|||ANOVA|||Month 6||-1.04|-1.50|< 0.001
71769894|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|97.5|-0.55|-0.01|||mixed-effects model|||Month 1||-0.01|-0.55|0.02
71769895|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.119|<|0.001|TWO_SIDED|97.5|-0.72|-0.18|||mixed-effects model|||Month 1||-0.18|-0.72|< 0.001
71724517|NCT01252186|142964733|NON_INFERIORITY_OR_EQUIVALENCE|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|422.76||||0.06|TWO_SIDED|95.0|-18.3|863.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||863.8|-18.3|0.060
71724518|NCT01252186|142964734|SUPERIORITY_OR_OTHER||Treatment Difference|-14.31||||0.745|TWO_SIDED|95.0|-100.8|72.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||72.2|-100.8|0.745
71724519|NCT01252186|142964734|SUPERIORITY_OR_OTHER||Treatment Difference|71.31||||0.115|TWO_SIDED|95.0|-17.5|160.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||160.1|-17.5|0.115
71724520|NCT01252186|142964735|SUPERIORITY_OR_OTHER||Treatment Difference|-17.14||||0.782|TWO_SIDED|95.0|-139.4|105.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||105.1|-139.4|0.782
71724521|NCT01252186|142964735|SUPERIORITY_OR_OTHER||Treatment Difference|97.09||||0.131|TWO_SIDED|95.0|-29.2|223.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||223.4|-29.2|0.131
71724522|NCT01252186|142964736|SUPERIORITY_OR_OTHER||Treatment Difference|-0.04||||0.428|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.1|0.428
71724523|NCT01252186|142964736|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.002|TWO_SIDED|95.0|-0.3|-0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.1|-0.3|0.002
71724524|NCT01252186|142964737|SUPERIORITY_OR_OTHER||Treatment Difference|-0.01||||0.868|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.1|-0.2|0.868
71724525|NCT01252186|142964737|SUPERIORITY_OR_OTHER||Treatment Difference|0.2||||0.012|TWO_SIDED|95.0|0.0|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|0.0|0.012
71724526|NCT01252186|142964738|SUPERIORITY_OR_OTHER||Treatment Difference|0.09||||0.317|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-0.1|0.317
71724527|NCT01252186|142964738|SUPERIORITY_OR_OTHER||Treatment Difference|-0.16||||0.081|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.0|-0.4|0.081
71724528|NCT01252186|142964739|SUPERIORITY_OR_OTHER||Treatment Difference|-0.004||||0.331|TWO_SIDED|95.0|-0.013|0.004|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.004|-0.013|0.331
71724529|NCT01252186|142964739|SUPERIORITY_OR_OTHER||Treatment Difference|-0.006||||0.173|TWO_SIDED|95.0|-0.015|0.003|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.003|-0.015|0.173
71724530|NCT01252186|142964740|SUPERIORITY_OR_OTHER||Treatment Difference|-0.57||||0.194|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.3|-1.4|0.194
71724531|NCT01252186|142964740|SUPERIORITY_OR_OTHER||Treatment Difference|-0.02||||0.967|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.9|-0.9|0.967
71657716|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||15.6|-4.8|
71724532|NCT01252186|142964741|SUPERIORITY_OR_OTHER||Treatment Difference|1.09||||0.648|TWO_SIDED|95.0|-3.6|5.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.8|-3.6|0.648
71724533|NCT01252186|142964741|SUPERIORITY_OR_OTHER||Treatment Difference|1.68||||0.496|TWO_SIDED|95.0|-3.2|6.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||6.6|-3.2|0.496
71724534|NCT01252186|142964742|SUPERIORITY_OR_OTHER||Treatment Difference|8.71||||0.405|TWO_SIDED|95.0|-11.9|29.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||29.3|-11.9|0.405
71724535|NCT01252186|142964742|SUPERIORITY_OR_OTHER||Treatment Difference|28.95||||0.008|TWO_SIDED|95.0|7.7|50.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||50.2|7.7|0.008
71724536|NCT01252186|142964743|SUPERIORITY_OR_OTHER||Treatment Difference|3.3||||0.425|TWO_SIDED|195.0|-4.9|11.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.5|-4.9|0.425
71724537|NCT01252186|142964743|SUPERIORITY_OR_OTHER||Treatment Difference|8.76||||0.041|TWO_SIDED|95.0|0.3|17.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||17.2|0.3|0.041
71724538|NCT01252186|142964744|SUPERIORITY_OR_OTHER||Treatment Difference|-2.4||||0.088|TWO_SIDED|95.0|-5.2|0.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.4|-5.2|0.088
71724539|NCT01252186|142964744|SUPERIORITY_OR_OTHER||Treatment Difference|-3.19||||0.028|TWO_SIDED|95.0|-6.0|-0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-0.3|-6.0|0.028
71724540|NCT01252186|142964745|SUPERIORITY_OR_OTHER||Treatment Difference|1.75||||0.631|TWO_SIDED|95.0|-5.4|8.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||8.9|-5.4|0.631
71724541|NCT01252186|142964745|SUPERIORITY_OR_OTHER||Treatment Difference|3.73||||0.323|TWO_SIDED|95.0|-3.7|11.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||11.2|-3.7|0.323
71724542|NCT01252186|142964746|SUPERIORITY_OR_OTHER||Treatment Difference|-0.86||||0.783|TWO_SIDED|595.0|-7.0|5.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||5.3|-7.0|0.783
71724543|NCT01252186|142964746|SUPERIORITY_OR_OTHER||Treatment Difference|-2.83||||0.384|TWO_SIDED|95.0|-9.2|3.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.6|-9.2|0.384
71724544|NCT01252186|142964747|SUPERIORITY_OR_OTHER||Treatment Difference|1.66||||0.572|TWO_SIDED|95.0|-4.1|7.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||7.5|-4.1|0.572
71724545|NCT01252186|142964747|SUPERIORITY_OR_OTHER||Treatment Difference|-20.98|||<|0.001|TWO_SIDED|95.0|-27.0|-15.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-15.0|-27.0|<0.001
71724546|NCT01252186|142964748|SUPERIORITY_OR_OTHER||Treatment Difference|-0.42||||0.841|TWO_SIDED|95.0|-4.6|3.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||3.7|-4.6|0.841
71724547|NCT01252186|142964748|SUPERIORITY_OR_OTHER||Treatment Difference|-10.53|||<|0.001|TWO_SIDED|95.0|-14.8|-6.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-6.3|-14.8|<0.001
71724548|NCT01252186|142964749|SUPERIORITY_OR_OTHER||Treatment Difference|-2.11||||0.227|TWO_SIDED|95.0|-5.6|1.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||1.3|-5.6|0.227
71724549|NCT01252186|142964749|SUPERIORITY_OR_OTHER||Treatment Difference|-5.99||||0.001|TWO_SIDED|95.0|-9.6|-2.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||-2.4|-9.6|0.001
71724550|NCT01252186|142964750|SUPERIORITY_OR_OTHER||Treatment Difference|0.33||||0.076|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.7|-0.0|0.076
71724551|NCT01252186|142964750|SUPERIORITY_OR_OTHER||Treatment Difference|0.44||||0.021|TWO_SIDED|95.0|0.1|0.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||0.8|0.1|0.021
71724552|NCT01252186|142964751|SUPERIORITY_OR_OTHER||Treatment Difference|44.46||||0.19|TWO_SIDED|95.0|-22.3|111.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.2|-22.3|0.190
71888049|NCT01162421|143296941|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.611|TWO_SIDED|95.0|-0.17|0.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.10|-0.17|0.611
71888050|NCT01162421|143296942|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.42||0.572|TWO_SIDED|95.0|-11.3|6.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||6.3|-11.3|0.572
71724553|NCT01252186|142964751|SUPERIORITY_OR_OTHER||Treatment Difference|9.74||||0.781|TWO_SIDED|95.0|-59.4|78.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||78.9|-59.4|0.781
71724554|NCT01252186|142964752|SUPERIORITY_OR_OTHER||Treatment Difference|-12.49||||0.843|TWO_SIDED|95.0|-136.4|111.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||111.4|-136.4|0.843
71724555|NCT01252186|142964752|SUPERIORITY_OR_OTHER||Treatment Difference|58.3||||0.376|TWO_SIDED|95.0|-71.3|187.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||187.9|-71.3|0.376
71724556|NCT01252186|142964753|SUPERIORITY_OR_OTHER||Treatment Difference|-4.01||||0.731|TWO_SIDED|95.0|-27.0|19.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||19.0|-27.0|0.731
71724557|NCT01252186|142964753|SUPERIORITY_OR_OTHER||Treatment Difference|130.15|||<|0.001|TWO_SIDED|95.0|106.2|154.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.||154.1|106.2|<0.001
71724558|NCT04283994|142964766|SUPERIORITY||Risk Difference (RD)|0.114||||0.023|TWO_SIDED|95.0|0.03|0.197||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.197|0.030|0.023
71769896|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.85|-0.23|||mixed-effects model|||Month 2||-0.23|-0.85|< 0.001
71769897|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||Month 2||-0.65|-1.27|< 0.001
71769898|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-0.95|-0.21|||mixed-effects model|||Month 4||-0.21|-0.95|< 0.001
71769899|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.164|<|0.001|TWO_SIDED|97.5|-1.72|-0.99|||mixed-effects model|||Month 4||-0.99|-1.72|< 0.001
71769900|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-0.99|-0.23|||mixed-effects model|||Month 5||-0.23|-0.99|< 0.001
71769901|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.168|<|0.001|TWO_SIDED|97.5|-1.75|-1.0|||mixed-effects model|||Month 5||-1.00|-1.75|< 0.001
71769902|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.08|-0.3|||mixed-effects model|||Month 6||-0.30|-1.08|< 0.001
71724559|NCT04283994|142964766|SUPERIORITY||Risk Difference (RD)|0.068||||0.294|TWO_SIDED|95.0|-0.013|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - usual care. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.150|-0.013|0.294
71724560|NCT04283994|142964766|SUPERIORITY||Risk Difference (RD)|-0.045||||0.952|TWO_SIDED|95.0|-0.134|0.044||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bidirectional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital site and dementia diagnosis. Confidence intervals using robust standard errors.|A total sample size of 600 (200 per arm) would give 80% power to detect a difference in proportions of 0.16 for each of the 3 pairwise comparisons assuming an overall 0.5 significance threshold, a Bonferroni adjustment for the 3 comparisons, and variance based on a proportion of 0.54.||0.044|-0.134|0.952
71724561|NCT04283994|142964773|SUPERIORITY||Mean Difference (Final Values)|-0.3||||1.65|TWO_SIDED|95.0|-1.3|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.7|-1.3|1.650
71724562|NCT04283994|142964773|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.985|TWO_SIDED|95.0|-1.6|0.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.5|-1.6|0.985
71724563|NCT04283994|142964773|SUPERIORITY||Mean Difference (Final Values)|0.2||||2.155|TWO_SIDED|95.0|-1.0|1.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.4|-1.0|2.155
71724564|NCT04283994|142964774|SUPERIORITY||Mean Difference (Final Values)|0.7||||2.169|TWO_SIDED|95.0|-3.1|4.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis,|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||4.4|-3.1|2.169
71724565|NCT04283994|142964774|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.391|TWO_SIDED|95.0|-7.5|1.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.0|-7.5|0.391
71724566|NCT04283994|142964774|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.21|TWO_SIDED|95.0|-0.3|8.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||8.2|-0.3|0.210
71769903|NCT01931670|143039658|SUPERIORITY||LS Mean of Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.175|<|0.001|TWO_SIDED|97.5|-1.67|-0.89|||mixed-effects model|||Month 6||-0.89|-1.67|< 0.001
71769904|NCT01931670|143039659|SUPERIORITY||Difference in LS Means|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.007|TWO_SIDED|95.0|-7.25|-1.16|||ANCOVA|||Month 1||-1.16|-7.25|0.007
71769905|NCT01931670|143039659|SUPERIORITY||Difference in LS Means|-7.55|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5|||ANCOVA|||Month 1||-4.50|-10.6|< 0.001
71769906|NCT01931670|143039659|SUPERIORITY||Difference in LS Means|-7.33|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.75|-3.91|||ANCOVA|||Month 3||-3.91|-10.75|< 0.001
71769907|NCT01931670|143039659|SUPERIORITY||Difference in LS Means|-15.43|STANDARD_ERROR_OF_MEAN|1.75|<|0.001|TWO_SIDED|95.0|-18.87|-11.99|||ANCOVA|||Month 3||-11.99|-18.87|< 0.001
71657717|NCT02504671|142831745|OTHER||Difference|29.7|||||TWO_SIDED|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.4|11.0|
71769908|NCT01931670|143039659|SUPERIORITY||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.81|-4.6|||ANCOVA|||Month 6||-4.60|-12.81|< 0.001
71769909|NCT01931670|143039659|SUPERIORITY||Difference in LS Means|-16.92|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-20.98|-12.86|||ANCOVA|||Month 6||-12.86|-20.98|< 0.001
71769910|NCT01931670|143039660|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|1.95||0.77|TWO_SIDED|95.0|-4.4|3.26|||ANCOVA|||Month 1||3.26|-4.40|0.77
71769911|NCT01931670|143039660|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|1.93||0.023|TWO_SIDED|95.0|-8.19|-0.61|||ANCOVA|||Month 1||-0.61|-8.19|0.023
71769912|NCT01931670|143039660|SUPERIORITY||Difference in LS Means|-2.74|STANDARD_ERROR_OF_MEAN|2.42||0.257|TWO_SIDED|95.0|-7.5|2.01|||ANCOVA|||Month 3||2.01|-7.50|0.257
71769913|NCT01931670|143039660|SUPERIORITY||Difference in LS Means|-10.69|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-15.37|-6.01|||ANCOVA|||Month 3||-6.01|-15.37|< 0.001
71769914|NCT01931670|143039660|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|2.91||0.315|TWO_SIDED|95.0|-8.66|2.8|||ANCOVA|||Month 6||2.80|-8.66|0.315
71724567|NCT04283994|142964775|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.01|TWO_SIDED|95.0|-0.8|2.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.4|-0.8|1.010
71724568|NCT04283994|142964775|SUPERIORITY||Mean Difference (Final Values)|0.0||||2.923|TWO_SIDED|95.0|-1.7|1.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||1.7|-1.7|2.923
71724569|NCT04283994|142964775|SUPERIORITY||Mean Difference (Final Values)|0.8||||1.034|TWO_SIDED|95.0|-0.9|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||2.5|-0.9|1.034
71724570|NCT04283994|142964776|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.384|TWO_SIDED|95.0|-1.0|7.9||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||7.9|-1.0|0.384
71724571|NCT04283994|142964776|SUPERIORITY||Mean Difference (Final Values)|-1.2||||1.923|TWO_SIDED|95.0|-6.1|3.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.7|-6.1|1.923
71724572|NCT04283994|142964776|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.166|TWO_SIDED|95.0|-0.1|9.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||9.4|-0.1|0.166
71724573|NCT04283994|142964777|SUPERIORITY||Risk Difference (RD)|-0.11||||0.16|TWO_SIDED|95.0|-0.23|0.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.00|-0.23|0.160
71724574|NCT04283994|142964777|SUPERIORITY||Risk Difference (RD)|-0.07||||0.652|TWO_SIDED|95.0|-0.18|0.04||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.04|-0.18|0.652
71724575|NCT04283994|142964777|SUPERIORITY||Risk Difference (RD)|-0.04||||1.39|TWO_SIDED|95.0|-0.16|0.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.07|-0.16|1.390
71724576|NCT04283994|142964778|SUPERIORITY||Risk Difference (RD)|0.05||||1.192|TWO_SIDED|95.0|-0.06|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.06|1.192
71724577|NCT04283994|142964778|SUPERIORITY||Risk Difference (RD)|0.01||||2.698|TWO_SIDED|95.0|-0.11|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.11|2.698
71888051|NCT01162421|143296942|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|5.15||0.13|TWO_SIDED|95.0|-2.4|18.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||18.2|-2.4|0.130
71888052|NCT01162421|143296942|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.26||0.649|TWO_SIDED|95.0|-12.9|8.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||8.1|-12.9|0.649
71888053|NCT01162421|143296942|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|4.8||0.579|TWO_SIDED|95.0|-12.3|6.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||6.9|-12.3|0.579
71769915|NCT01931670|143039660|SUPERIORITY||Difference in LS Means|-14.1|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-19.64|-8.55|||ANCOVA|||Month 6||-8.55|-19.64|< 0.001
71724578|NCT04283994|142964778|SUPERIORITY||Risk Difference (RD)|0.04||||1.477|TWO_SIDED|95.0|-0.08|0.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.16|-0.08|1.477
71724579|NCT04283994|142964779|SUPERIORITY||Mean Difference (Final Values)|-0.57||||2.293|TWO_SIDED|95.0|-4.3|3.16||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||3.16|-4.30|2.293
71724580|NCT04283994|142964779|SUPERIORITY||Mean Difference (Final Values)|-0.48||||2.381|TWO_SIDED|95.0|-4.11|3.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.14|-4.11|2.381
71724581|NCT04283994|142964779|SUPERIORITY||Mean Difference (Final Values)|-0.09||||2.893|TWO_SIDED|95.0|-3.86|3.69||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||3.69|-3.86|2.893
71724582|NCT04283994|142964780|SUPERIORITY||Risk Difference (RD)|0.0||||2.829|TWO_SIDED|95.0|-0.13|0.12||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.12|-0.13|2.829
71724583|NCT04283994|142964780|SUPERIORITY||Risk Difference (RD)|0.11||||0.188|TWO_SIDED|95.0|-0.01|0.24||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.24|-0.01|0.188
71724584|NCT04283994|142964780|SUPERIORITY||Risk Difference (RD)|-0.12||||0.19|TWO_SIDED|95.0|-0.24|0.01||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.01|-0.24|0.190
71724585|NCT04283994|142964781|SUPERIORITY||Risk Difference (RD)|0.03||||1.994|TWO_SIDED|95.0|-0.09|0.14||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.14|-0.09|1.994
71769916|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.019|TWO_SIDED|95.0|-1.86|-0.17|||ANCOVA|||Month 1||-0.17|-1.86|0.019
71769917|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.433||0.028|TWO_SIDED|95.0|-1.8|-0.1|||ANCOVA|||Month 1||-0.10|-1.80|0.028
71769918|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.397||0.014|TWO_SIDED|95.0|-1.76|-0.2|||ANCOVA|||Month 2||-0.20|-1.76|0.014
71769919|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.22|-0.65|||ANCOVA|||Month 2||-0.65|-2.22|< 0.001
71769920|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.432||0.121|TWO_SIDED|95.0|-1.52|0.18|||ANCOVA|||Month 3||0.18|-1.52|0.121
71769921|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.431||0.001|TWO_SIDED|95.0|-2.25|-0.56|||ANCOVA|||Month 3||-0.56|-2.25|0.001
71769922|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-1.25|STANDARD_ERROR_OF_MEAN|0.561||0.026|TWO_SIDED|95.0|-2.35|-0.15|||ANCOVA|||Month 4||-0.15|-2.35|0.026
71769923|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-1.48|STANDARD_ERROR_OF_MEAN|0.555||0.008|TWO_SIDED|95.0|-2.57|-0.39|||ANCOVA|||Month 4||-0.39|-2.57|0.008
71769924|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.327||0.027|TWO_SIDED|95.0|-1.37|-0.08|||ANCOVA|||Month 5||-0.08|-1.37|0.027
71769925|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-1.11|STANDARD_ERROR_OF_MEAN|0.327|<|0.001|TWO_SIDED|95.0|-1.75|-0.47|||ANCOVA|||Month 5||-0.47|-1.75|< 0.001
71769926|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.391||0.143|TWO_SIDED|95.0|-1.34|0.2|||ANCOVA|||Month 6||0.20|-1.34|0.143
71769927|NCT01931670|143039661|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.385||0.019|TWO_SIDED|95.0|-1.67|-0.15|||ANCOVA|||Month 6||-0.15|-1.67|0.019
71769928|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.415||0.131|TWO_SIDED|95.0|-1.44|0.19|||ANCOVA|||Month 1||0.19|-1.44|0.131
71769929|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.037|TWO_SIDED|95.0|-1.65|-0.05|||ANCOVA|||Month 1||-0.05|-1.65|0.037
71724586|NCT04283994|142964781|SUPERIORITY||Risk Difference (RD)|0.07||||0.771|TWO_SIDED|95.0|-0.05|0.19||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.19|-0.05|0.771
71724587|NCT04283994|142964781|SUPERIORITY||Risk Difference (RD)|-0.04||||1.447|TWO_SIDED|95.0|-0.17|0.08||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|"Complete case analysis. Unsure responses counted as non-events."||0.08|-0.17|1.447
71724588|NCT04283994|142964784|SUPERIORITY||Risk Difference (RD)|-0.012||||1.836|TWO_SIDED|95.0|-0.058|0.034||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.034|-0.058|1.836
71724589|NCT04283994|142964784|SUPERIORITY||Risk Difference (RD)|0.021||||1.25|TWO_SIDED|95.0|-0.03|0.073||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.073|-0.030|1.250
71724590|NCT04283994|142964784|SUPERIORITY||Risk Difference (RD)|-0.033||||0.581|TWO_SIDED|95.0|-0.084|0.017||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.017|-0.084|0.581
71724591|NCT04283994|142964785|SUPERIORITY||Risk Difference (RD)|-0.039||||0.692|TWO_SIDED|95.0|-0.102|0.025||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.025|-0.102|0.692
71769930|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.423||0.008|TWO_SIDED|95.0|-1.96|-0.29|||ANCOVA|||Month 2||-0.29|-1.96|0.008
71769931|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-1.44|STANDARD_ERROR_OF_MEAN|0.426|<|0.001|TWO_SIDED|95.0|-2.27|-0.6|||ANCOVA|||Month 2||-0.60|-2.27|< 0.001
71769932|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.434||0.036|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.036
71769933|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.431||0.035|TWO_SIDED|95.0|-1.76|-0.06|||ANCOVA|||Month 3||-0.06|-1.76|0.035
71769934|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.453||0.452|TWO_SIDED|95.0|-1.23|0.55|||ANCOVA|||Month 4||0.55|-1.23|0.452
71769935|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.432||0.002|TWO_SIDED|95.0|-2.18|-0.48|||ANCOVA|||Month 4||-0.48|-2.18|0.002
71769936|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-1.12|STANDARD_ERROR_OF_MEAN|0.443||0.012|TWO_SIDED|95.0|-1.99|-0.25|||ANCOVA|||Month 5||-0.25|-1.99|0.012
71888054|NCT01162421|143296942|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.03||0.826|TWO_SIDED|95.0|-11.1|8.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||8.9|-11.1|0.826
71724592|NCT04283994|142964785|SUPERIORITY||Risk Difference (RD)|0.038||||0.887|TWO_SIDED|95.0|-0.033|0.109||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.109|-0.033|0.887
71769937|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.439|<|0.001|TWO_SIDED|95.0|-2.5|-0.78|||ANCOVA|||Month 5||-0.78|-2.5|< 0.001
71769938|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.478||0.13|TWO_SIDED|95.0|-1.67|0.21|||ANCOVA|||Month 6||0.21|-1.67|0.13
71769939|NCT01931670|143039662|SUPERIORITY||Difference in LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.454||0.001|TWO_SIDED|95.0|-2.34|-0.56|||ANCOVA|||Month 6||-0.56|-2.34|0.001
71769940|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-1.34|STANDARD_ERROR_OF_MEAN|1.01||0.186|TWO_SIDED|95.0|-3.32|0.65|||ANCOVA|||Month 1||0.65|-3.32|0.186
71769941|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-3.09|STANDARD_ERROR_OF_MEAN|1.013||0.002|TWO_SIDED|95.0|-5.08|-1.1|||ANCOVA|||Month 1||-1.10|-5.08|0.002
71769942|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-1.31|STANDARD_ERROR_OF_MEAN|1.005||0.195|TWO_SIDED|95.0|-3.28|0.67|||ANCOVA|||Month 2||0.67|-3.28|0.195
71769943|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-3.65|STANDARD_ERROR_OF_MEAN|1.007|<|0.001|TWO_SIDED|95.0|-5.63|-1.67|||ANCOVA|||Month 2||-1.67|-5.63|< 0.001
71769944|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|1.02||0.047|TWO_SIDED|95.0|-4.03|-0.02|||ANCOVA|||Month 3||-0.02|-4.03|0.047
71769945|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-3.2|STANDARD_ERROR_OF_MEAN|1.021||0.002|TWO_SIDED|95.0|-5.21|-1.19|||ANCOVA|||Month 3||-1.19|-5.21|0.002
71769946|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.998||0.103|TWO_SIDED|95.0|-3.59|0.33|||ANCOVA|||Month 4||0.33|-3.59|0.103
71724593|NCT04283994|142964785|SUPERIORITY||Risk Difference (RD)|-0.077||||0.08|TWO_SIDED|95.0|-0.145|-0.009||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Risk difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||-0.009|-0.145|0.080
71724594|NCT04283994|142964786|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.293|TWO_SIDED|95.0|0.9|2.1||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.1|0.9|0.293
71724595|NCT04283994|142964786|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.027|TWO_SIDED|95.0|1.1|2.5||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis|Hazard ratio = clinician-facing intervention / usual care. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||2.5|1.1|0.027
71724596|NCT04283994|142964786|SUPERIORITY||Hazard Ratio (HR)|0.8||||1.009|TWO_SIDED|95.0|0.6|1.2||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Cox|Wald test adjusting for hospital site and dementia diagnosis.|Hazard ratio = bi-directional intervention / clinician-facing intervention. Estimated via cox proportional hazards regression after adjusting for hospital and dementia diagnosis. Exponentiated Wald confidence intervals.|Censoring by death.||1.2|0.6|1.009
71724597|NCT04283994|142964787|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1.366|TWO_SIDED|95.0|-1.55|0.7||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.70|-1.55|1.366
71724598|NCT04283994|142964787|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.978|TWO_SIDED|95.0|-1.73|0.58||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.58|-1.73|0.978
71830251|NCT04603924|143165239|OTHER||||||||||||||||||"For the analysis of this efficacy endpoint, missing scores of the WHO Ordinal Scale for Clinical Improvement were be assumed to be \> 2 (i.e., no hospital discharge). Median number of days to a 2-point improvement and corresponding 95% confidence interval were estimated from the Kaplan-Meier curves.~In some cases the 95% confidence interval was Not Evaluable (NE) by this method."|||
71830252|NCT01904071|143165247|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
71830253|NCT01904071|143165248|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
71830254|NCT01904071|143165249|SUPERIORITY_OR_OTHER||||||<|0.005|||||||ANOVA|||||||<.005
71830255|NCT01904071|143165250|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<.001
71830256|NCT01904071|143165251|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANOVA|||||||0.342
71830257|NCT00189202|143165252|EQUIVALENCE|Equivalence margin 8% plus or minus 4.||||||0.28|||||||Mantel Haenszel|||||||0.28
71830258|NCT00189202|143165253|OTHER|||||||0.7|||||||Kaplan-Meier|||||||0.70
71888055|NCT01162421|143296942|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.72||0.675|TWO_SIDED|95.0|-13.8|9.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||9.0|-13.8|0.675
71888056|NCT01162421|143296943|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.57||0.458|TWO_SIDED|95.0|-2.0|4.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3||4.3|-2.0|0.458
71888057|NCT01162421|143296943|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.76||0.419|TWO_SIDED|95.0|-4.9|2.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6||2.1|-4.9|0.419
71830259|NCT01444417|143165258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0497||||0.0018|TWO_SIDED|95.0|1.896|43.199|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||43.199|1.896|0.0018
71830260|NCT01444417|143165259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0443||||0.0002|TWO_SIDED|95.0|2.535|32.265|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.||32.265|2.535|0.0002
71830261|NCT01444417|143165260|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).||||||0.0004
71830262|NCT01444417|143165261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.813||||0.7103|TWO_SIDED|95.0|0.277|2.391|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group||||2.391|0.277|0.7103
71830263|NCT02476409|143165272|SUPERIORITY|||||||0.094|||||||Kruskal-Wallis|||||||0.094
71830264|NCT02476409|143165273|SUPERIORITY|||||||0.166|||||||Kruskal-Wallis|||||||0.166
71830265|NCT02476409|143165273|SUPERIORITY|||||||0.491|||||||Kruskal-Wallis|||||||0.491
71830266|NCT02476409|143165274|SUPERIORITY|||||||0.543|||||||Kruskal-Wallis|||P-value for Change in Dyspnea VAS - Baseline to Day 3 Tolvaptan versus placebo.||||0.543
71724599|NCT04283994|142964787|SUPERIORITY||Mean Difference (Final Values)|0.15||||2.39|TWO_SIDED|95.0|-0.99|1.3||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.30|-0.99|2.390
71724600|NCT04283994|142964788|SUPERIORITY||Mean Difference (Final Values)|0.47||||1.125|TWO_SIDED|95.0|-0.57|1.51||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.51|-0.57|1.125
71769947|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-4.78|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-6.72|-2.83|||ANCOVA|||Month 4||-2.83|-6.72|< 0.001
71769948|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|-4.2|-0.38|||ANCOVA|||Month 5||-0.38|-4.20|0.019
71769949|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-5.14|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|-7.06|-3.22|||ANCOVA|||Month 5||-3.22|-7.06|< 0.001
71769950|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|1.112||0.383|TWO_SIDED|95.0|-3.16|1.22|||ANCOVA|||Month 6||1.22|-3.16|0.383
71769951|NCT01931670|143039663|SUPERIORITY||Difference in LS Means|-3.02|STANDARD_ERROR_OF_MEAN|1.092||0.006|TWO_SIDED|95.0|-5.17|-0.87|||ANCOVA|||Month 6||-0.87|-5.17|0.006
71769952|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|0.01|STANDARD_ERROR_OF_MEAN|0.422||0.975|TWO_SIDED|95.0|-0.81|0.84|||ANCOVA|||Month 1||0.84|-0.81|0.975
71769953|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.415||0.969|TWO_SIDED|95.0|-0.83|0.8|||ANCOVA|||Month 1||0.80|-0.83|0.969
71724601|NCT04283994|142964788|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.258|TWO_SIDED|95.0|-0.13|1.94||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.94|-0.13|0.258
71769954|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.22|STANDARD_ERROR_OF_MEAN|0.389||0.569|TWO_SIDED|95.0|-0.99|0.54|||ANCOVA|||Month 2||0.54|-0.99|0.569
71769955|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.393||0.311|TWO_SIDED|95.0|-1.17|0.37|||ANCOVA|||Month 2||0.37|-1.17|0.311
71769956|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|0.43|STANDARD_ERROR_OF_MEAN|0.505||0.398|TWO_SIDED|95.0|-0.56|1.42|||ANCOVA|||Month 3||1.42|-0.56|0.398
71769957|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.505||0.761|TWO_SIDED|95.0|-1.15|0.84|||ANCOVA|||Month 3||0.84|-1.15|0.761
71769958|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.491||0.874|TWO_SIDED|95.0|-0.89|1.04|||ANCOVA|||Month 4||1.04|-0.89|0.874
71830267|NCT02476409|143165275|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.050
71769959|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.468||0.048|TWO_SIDED|95.0|-1.85|-0.01|||ANCOVA|||Month 4||-0.01|-1.85|0.048
71769960|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.635||0.16|TWO_SIDED|95.0|-2.14|0.35|||ANCOVA|||Month 5||0.35|-2.14|0.16
71769961|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.63||0.152|TWO_SIDED|95.0|-2.14|0.33|||ANCOVA|||Month 5||0.33|-2.14|0.152
71769962|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.498||0.095|TWO_SIDED|95.0|-1.81|0.15|||ANCOVA|||Month 6||0.15|-1.81|0.095
71769963|NCT01931670|143039664|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.474||0.071|TWO_SIDED|95.0|-1.79|0.07|||ANCOVA|||Month 6||0.07|-1.79|0.071
71769964|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|1.106||0.098|TWO_SIDED|95.0|-4.01|0.34|||ANCOVA|||Month 1||0.34|-4.01|0.098
71769965|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-3.72|STANDARD_ERROR_OF_MEAN|1.113|<|0.001|TWO_SIDED|95.0|-5.91|-1.54|||ANCOVA|||Month 1||-1.54|-5.91|< 0.001
71769966|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|1.091||0.065|TWO_SIDED|95.0|-4.16|0.13|||ANCOVA|||Month 2||0.13|-4.16|0.065
71769967|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-5.1|STANDARD_ERROR_OF_MEAN|1.089|<|0.001|TWO_SIDED|95.0|-7.24|-2.96|||ANCOVA|||Month 2||-2.96|-7.24|< 0.001
71769968|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|1.14||0.02|TWO_SIDED|95.0|-4.89|-0.41|||ANCOVA|||Month 3||-0.41|-4.89|0.02
71769969|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-4.64|STANDARD_ERROR_OF_MEAN|1.135|<|0.001|TWO_SIDED|95.0|-6.87|-2.41|||ANCOVA|||Month 3||-2.41|-6.87|< 0.001
71769970|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-2.72|STANDARD_ERROR_OF_MEAN|1.138||0.017|TWO_SIDED|95.0|-4.95|-0.48|||ANCOVA|||Month 4||-0.48|-4.95|0.017
71769971|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-6.27|STANDARD_ERROR_OF_MEAN|1.124|<|0.001|TWO_SIDED|95.0|-8.48|-4.06|||ANCOVA|||Month 4||-4.06|-8.48|< 0.001
71769972|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|1.095||0.023|TWO_SIDED|95.0|-4.64|-0.34|||ANCOVA|||Month 5||-0.34|-4.64|0.023
71769973|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-5.83|STANDARD_ERROR_OF_MEAN|1.095|<|0.001|TWO_SIDED|95.0|-7.98|-3.68|||ANCOVA|||Month 5||-3.68|-7.98|< 0.001
71769974|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|1.264||0.311|TWO_SIDED|95.0|-3.77|1.2|||ANCOVA|||Month 6||1.20|-3.77|0.311
71830268|NCT02476409|143165276|SUPERIORITY|||||||0.092|||||||Fisher Exact|||||||0.092
71830269|NCT02476409|143165277|SUPERIORITY|||||||0.034|||||||Kruskal-Wallis|||||||0.034
71830270|NCT02476409|143165278|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||||||0.643
71830271|NCT00275392|143165279|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||0.026
71724602|NCT04283994|142964788|SUPERIORITY||Mean Difference (Final Values)|-0.44||||1.267|TWO_SIDED|95.0|-1.5|0.63||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.63|-1.5|1.267
71724603|NCT04283994|142964789|SUPERIORITY||Mean Difference (Final Values)|0.32||||1.594|TWO_SIDED|95.0|-0.68|1.32||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.32|-0.68|1.594
71724604|NCT04283994|142964789|SUPERIORITY||Mean Difference (Final Values)|0.29||||1.803|TWO_SIDED|95.0|-0.79|1.36||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.36|-0.79|1.803
71724605|NCT04283994|142964789|SUPERIORITY||Mean Difference (Final Values)|0.03||||2.851|TWO_SIDED|95.0|-1.01|1.07||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||1.07|-1.01|2.851
71724606|NCT04283994|142964790|SUPERIORITY||Mean Difference (Final Values)|-0.28||||1.243|TWO_SIDED|95.0|-0.97|0.4||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.40|-0.97|1.243
71724607|NCT04283994|142964790|SUPERIORITY||Mean Difference (Final Values)|-0.33||||1.032|TWO_SIDED|95.0|-1.0|0.35||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.35|-1.00|1.032
71769975|NCT01931670|143039665|SUPERIORITY||Difference in LS Means|-3.97|STANDARD_ERROR_OF_MEAN|1.241||0.001|TWO_SIDED|95.0|-6.42|-1.53|||ANCOVA|||Month 6||-1.53|-6.42|0.001
71769976|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.81|0.62|||ANCOVA|||Month 1||0.62|-1.81|0.335
71769977|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.611||0.242|TWO_SIDED|95.0|-1.91|0.48|||ANCOVA|||Month 1||0.48|-1.91|0.242
71724608|NCT04283994|142964790|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.742|TWO_SIDED|95.0|-0.7|0.78||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.78|-0.70|2.742
71724609|NCT04283994|142964791|SUPERIORITY||Mean Difference (Final Values)|-0.02||||2.658|TWO_SIDED|95.0|-0.26|0.22||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.22|-0.26|2.658
71769978|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.652||0.042|TWO_SIDED|95.0|-2.61|-0.05|||ANCOVA|||Month 2||-0.05|-2.61|0.042
71769979|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-1.77|STANDARD_ERROR_OF_MEAN|0.656||0.007|TWO_SIDED|95.0|-3.06|-0.48|||ANCOVA|||Month 2||-0.48|-3.06|0.007
71769980|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.71||0.503|TWO_SIDED|95.0|-1.87|0.92|||ANCOVA|||Month 3||0.92|-1.87|0.503
71769981|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.707||0.169|TWO_SIDED|95.0|-2.36|0.41|||ANCOVA|||Month 3||0.41|-2.36|0.169
71769982|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.737||0.675|TWO_SIDED|95.0|-1.76|1.14|||ANCOVA|||Month 4||1.14|-1.76|0.675
71769983|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.703||0.002|TWO_SIDED|95.0|-3.55|-0.79|||ANCOVA|||Month 4||-0.79|-3.55|0.002
71769984|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-2.04|STANDARD_ERROR_OF_MEAN|0.856||0.017|TWO_SIDED|95.0|-3.72|-0.36|||ANCOVA|||Month 5||-0.36|-3.72|0.017
71769985|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-2.54|STANDARD_ERROR_OF_MEAN|0.848||0.003|TWO_SIDED|95.0|-4.21|-0.87|||ANCOVA|||Month 5||-0.87|-4.21|0.003
71769986|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|0.778||0.042|TWO_SIDED|95.0|-3.12|-0.06|||ANCOVA|||Month 6||-0.06|-3.12|0.042
71769987|NCT01931670|143039666|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|0.738||0.002|TWO_SIDED|95.0|-3.73|-0.83|||ANCOVA|||Month 6||-0.83|-3.73|0.002
71830272|NCT00275392|143165279|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||main effect of time|RM ANOVA|||||||<.001
71830273|NCT00275392|143165279|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||main effect of group|RM ANOVA|||||||>.05
71830274|NCT00275392|143165280|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Interaction effect|RM ANOVA|||||||> 0.05
71724610|NCT04283994|142964791|SUPERIORITY||Mean Difference (Final Values)|0.07||||1.523|TWO_SIDED|95.0|-0.14|0.29||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.29|-0.14|1.523
71724611|NCT04283994|142964791|SUPERIORITY||Mean Difference (Final Values)|-0.09||||1.381|TWO_SIDED|95.0|-0.33|0.15||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|||0.15|-0.33|1.381
71724612|NCT04283994|142964792|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.191|TWO_SIDED|95.0|-0.18|0.25||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.25|-0.18|2.191
71724613|NCT04283994|142964792|SUPERIORITY||Mean Difference (Final Values)|0.04||||2.138|TWO_SIDED|95.0|-0.19|0.27||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = clinician-facing intervention - usual care. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||0.27|-0.19|2.138
71724614|NCT04283994|142964792|SUPERIORITY||Mean Difference (Final Values)|-0.01||||2.879|TWO_SIDED|95.0|-0.23|22.0||P-value is after a Bonferroni adjustment for three comparisons. The threshold for statistical significance was 0.05.|Regression, Linear|Wald test with robust standard errors, adjusting for hospital site and dementia diagnosis.|Mean difference = bi-directional intervention - clinician-facing intervention. Estimated via linear regression after adjusting for hospital and dementia diagnosis. Confidence intervals using robust standard errors.|Complete case analysis.||022|-0.23|2.879
71724615|NCT00487942|142964825|SUPERIORITY_OR_OTHER||Effect size|-0.04|||||TWO_SIDED|95.0|-0.81|0.73||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.81|
71724616|NCT00487942|142964825|SUPERIORITY_OR_OTHER||Effect size|0.09|||||TWO_SIDED|95.0|-0.68|0.86||Inferential statistics were not performed|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.68|
71724617|NCT00487942|142964825|SUPERIORITY_OR_OTHER||Effect size|0.15|||||TWO_SIDED|95.0|-0.66|0.95||Inferential statistics were not performed.|ANCOVA|||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.95|-0.66|
71724618|NCT00487942|142964826|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.8|0.83||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.80|
71724619|NCT00487942|142964826|SUPERIORITY_OR_OTHER||Effect size|0.31|||||TWO_SIDED|95.0|-0.51|1.14||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.14|-0.51|
71769988|NCT01992159|143039688|SUPERIORITY||Treatment Difference|7.5|||<|0.0001|ONE_SIDED|95.0|6.5|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||6.5|< 0.0001
71769989|NCT01992159|143039688|SUPERIORITY||Treatment Difference|12.4|||<|0.0001|ONE_SIDED|95.0|11.1|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||11.1|< 0.0001
71830275|NCT00275392|143165280|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|||||main effect of time|RM ANOVA|||||||.016
71724620|NCT00487942|142964826|SUPERIORITY_OR_OTHER||Effect size|0.16|||||TWO_SIDED|95.0|-0.66|0.98||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.66|
71724621|NCT00487942|142964827|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
71724622|NCT00487942|142964827|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.86|0.66||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.66|-0.86|
71724623|NCT00487942|142964827|SUPERIORITY_OR_OTHER||Effect size|0.49|||||TWO_SIDED|95.0|-0.31|1.28||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.28|-0.31|
71724624|NCT00487942|142964828|SUPERIORITY_OR_OTHER||Effect Size|-0.27|||||TWO_SIDED|95.0|-1.03|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.03|
71724625|NCT00487942|142964828|SUPERIORITY_OR_OTHER||Effect Size|0.11|||||TWO_SIDED|95.0|-0.65|0.88||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.65|
71724626|NCT00487942|142964828|SUPERIORITY_OR_OTHER||Effect Size|-0.18|||||TWO_SIDED|95.0|-0.97|0.6||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.60|-0.97|
71769990|NCT01992159|143039688|SUPERIORITY||Treatment Difference|16.0|||<|0.0001|ONE_SIDED|95.0|14.6|||One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||14.6|< 0.0001
71724627|NCT00487942|142964829|SUPERIORITY_OR_OTHER||Effect Size|-0.32|||||TWO_SIDED|95.0|-1.08|0.44||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.44|-1.08|
71724628|NCT00487942|142964829|SUPERIORITY_OR_OTHER||Effect Size|-0.02|||||TWO_SIDED|95.0|-0.77|0.74||Inferential Statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.77|
71830276|NCT00275392|143165280|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Main effect of Group|RM ANOVA|||||||>.05
71830277|NCT00468052|143165281|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Null hypothesis is not significantly different from group D and F.|Wilcoxon (Mann-Whitney)|||Sixty subjects were required per group to determine that with Dex would decrease the incidence of severe EA after surgery by 50% with 80% power (0.05)in comparison with the control group.60 subjects were required by group to show the that intraoperative rescue fentanyl and rescue morphine in the PACU would be 50% lower in subjects receiving dex.||||.001
71830278|NCT00468052|143165281|NON_INFERIORITY_OR_EQUIVALENCE|Treatment with Dex would reduce the incidence of severe agitation be 50% with an 80% power (alpha 0.05)||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis dexmedetomidine would be a safe and effective substitute to opiates in reducing pain and the incidence of severe EA||||.001
71830279|NCT00468052|143165282|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.004
71888058|NCT01162421|143296943|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.42||0.692|TWO_SIDED|95.0|-2.3|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||3.4|-2.3|0.692
71888059|NCT01162421|143296943|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.69||0.357|TWO_SIDED|95.0|-1.8|5.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||5.0|-1.8|0.357
71888060|NCT01162421|143296943|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.42|TWO_SIDED|95.0|-2.0|4.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||4.7|-2.0|0.420
71724629|NCT00487942|142964829|SUPERIORITY_OR_OTHER||Effect Size|-0.1|||||TWO_SIDED|95.0|-0.89|0.68||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.89|
71724630|NCT00487942|142964830|SUPERIORITY_OR_OTHER||Effect Size|0.15|||||TWO_SIDED|95.0|-0.61|0.9||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.90|-0.61|
71724631|NCT00487942|142964830|SUPERIORITY_OR_OTHER||Effect Size|0.25|||||TWO_SIDED|95.0|-0.5|1.01||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.50|
71830280|NCT00468052|143165284|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
71888061|NCT01162421|143296943|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.38|TWO_SIDED|95.0|-1.8|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||4.5|-1.8|0.380
71888062|NCT01162421|143296944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.046|TWO_SIDED|95.0|0.0|1.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3||1.1|0.0|0.046
71888063|NCT01162421|143296944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|0.3|1.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6||1.3|0.3|0.003
71724632|NCT00487942|142964830|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.34|1.25||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.25|-0.34|
71830281|NCT00468052|143165285|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
71830282|NCT00566527|143165308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 2 - Arm 3)|-0.91|||||TWO_SIDED|95.0|-2.82|0.87||||||Measles difference||0.87|-2.82|
71830283|NCT00566527|143165308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 2 - Arm 3)|0.03|||||TWO_SIDED|95.0|-1.2|1.32||||||Mumps difference||1.32|-1.20|
71830284|NCT00566527|143165308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 2 - Arm 3)|-0.22|||||TWO_SIDED|95.0|-1.55|1.03||||||Rubella difference||1.03|-1.55|
71830285|NCT00566527|143165308|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 2 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.28|1.1||||||Varicella difference||1.10|-1.28|
71830286|NCT00566527|143165309|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Measles Response Rate (Arm 1 - Arm 3)|-3.97|||||TWO_SIDED|95.0|-6.44|-1.87||||||Measles difference||-1.87|-6.44|
71830287|NCT00566527|143165309|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Mumps Response Rate (Arm 1 - Arm 3)|-0.35|||||TWO_SIDED|95.0|-1.71|1.01||||||Mumps difference||1.01|-1.71|
71830288|NCT00566527|143165309|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -5. Values are shown as percentages.|Rubella Response Rate (Arm 1 - Arm 3)|-0.15|||||TWO_SIDED|95.0|-1.34|1.09||||||Rubella difference||1.09|-1.34|
71830289|NCT00566527|143165309|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared when the lower bound of the 95% CI was \> -10. Values are shown as percentages.|Varicella Response Rate (Arm 1 - Arm 3)|0.0|||||TWO_SIDED|95.0|-1.83|1.1||||||Varicella difference||1.10|-1.83|
71830290|NCT00457743|143165330|SUPERIORITY_OR_OTHER||Disease control Rate (percentage)|56.7||||||95.0|37.4|74.5|||||The disease control rate, defined as the percentage of subjects confirmed with CR, PR, and SD \>=10 weeks on study according to RECIST.|||74.5|37.4|
71888064|NCT01162421|143296944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.24||0.204|TWO_SIDED|95.0|-0.2|0.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9||0.8|-0.2|0.204
71888065|NCT01162421|143296944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.227|TWO_SIDED|95.0|-0.2|0.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12||0.7|-0.2|0.227
71888066|NCT01162421|143296944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.86|TWO_SIDED|95.0|-0.4|0.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18||0.5|-0.4|0.860
71888067|NCT01162421|143296944|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.476|TWO_SIDED|95.0|-0.3|0.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24||0.6|-0.3|0.476
71724633|NCT00487942|142964831|SUPERIORITY_OR_OTHER||Effect Size|0.45|||||TWO_SIDED|95.0|-0.33|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.33|
71724634|NCT00487942|142964831|SUPERIORITY_OR_OTHER||Effect Size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
71724635|NCT00487942|142964831|SUPERIORITY_OR_OTHER||Effect Size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.68|
71724636|NCT00487942|142964832|SUPERIORITY_OR_OTHER||Effect Size|0.39|||||TWO_SIDED|95.0|-0.37|1.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.37|
71769991|NCT01992159|143039689|SUPERIORITY||Treatment Difference|5.3|||<|0.0001|ONE_SIDED|95.0|4.4||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||4.4|< 0.0001
71769992|NCT01992159|143039689|SUPERIORITY||Treatment Difference|9.0|||<|0.0001|ONE_SIDED|95.0|8.0||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||8.0|< 0.0001
71769993|NCT01992159|143039689|SUPERIORITY||Treatment Difference|11.9|||<|0.0001|ONE_SIDED|95.0|10.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||10.6|< 0.0001
71769994|NCT01992159|143039690|SUPERIORITY||Treatment Difference|0.6||||0.125|ONE_SIDED|95.0|-0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.3|0.1250
71769995|NCT01992159|143039690|SUPERIORITY||Treatment Difference|1.7||||0.0002|ONE_SIDED|95.0|0.9||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.9|0.0002
71769996|NCT01992159|143039690|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.7|< 0.0001
71888068|NCT00565617|143296978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
71657718|NCT02504671|142831745|OTHER||Difference|40.5|||||TWO_SIDED|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||59.5|21.6|
71724637|NCT00487942|142964832|SUPERIORITY_OR_OTHER||Effect Size|-0.05|||||TWO_SIDED|95.0|-0.81|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.81|
71724638|NCT00487942|142964832|SUPERIORITY_OR_OTHER||Effect Size|-0.01|||||TWO_SIDED|95.0|-0.8|0.77||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.77|-0.80|
71724639|NCT00487942|142964833|SUPERIORITY_OR_OTHER||Effect Size|-0.99|||||TWO_SIDED|95.0|-1.79|-0.19||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.19|-1.79|
71724640|NCT00487942|142964833|SUPERIORITY_OR_OTHER||Effect Size|-0.66|||||TWO_SIDED|95.0|-1.44|0.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.11|-1.44|
71769997|NCT01992159|143039691|SUPERIORITY||Treatment Difference|1.5||||0.0012|ONE_SIDED|95.0|0.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.7|0.0012
71724641|NCT00487942|142964833|SUPERIORITY_OR_OTHER||Effect Size|-0.03|||||TWO_SIDED|95.0|-0.82|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.82|
71724642|NCT00487942|142964834|SUPERIORITY_OR_OTHER||Effect Size|0.46|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
71724643|NCT00487942|142964834|SUPERIORITY_OR_OTHER||Effect Size|0.08|||||TWO_SIDED|95.0|-0.68|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.68|
71769998|NCT01992159|143039691|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.8||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.8|< 0.0001
71769999|NCT01992159|143039691|SUPERIORITY||Treatment Difference|4.1|||<|0.0001|ONE_SIDED|95.0|3.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||3.3|< 0.0001
71770000|NCT01992159|143039692|SUPERIORITY||Treatment Difference|0.3||||0.2846|ONE_SIDED|95.0|-0.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||-0.6|0.2846
71770001|NCT01992159|143039692|SUPERIORITY||Treatment Difference|1.3||||0.0151|ONE_SIDED|95.0|0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.3|0.0151
71724644|NCT00487942|142964834|SUPERIORITY_OR_OTHER||Effect Size|0.81|||||TWO_SIDED|95.0|0.0|1.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.63|-0.00|
71724645|NCT00487942|142964835|SUPERIORITY_OR_OTHER||Effect Size|-0.39|||||TWO_SIDED|95.0|-1.16|0.37||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.37|-1.16|
71724646|NCT00487942|142964835|SUPERIORITY_OR_OTHER||Effect Size|-0.45|||||TWO_SIDED|95.0|-1.21|0.31||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.31|-1.21|
71724647|NCT00487942|142964835|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-0.99|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-0.99|
71724648|NCT00487942|142964836|SUPERIORITY_OR_OTHER||Effect Size|0.47|||||TWO_SIDED|95.0|-0.3|1.23||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.23|-0.30|
71724649|NCT00487942|142964836|SUPERIORITY_OR_OTHER||Effect Size|0.28|||||TWO_SIDED|95.0|-0.48|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.48|
71724650|NCT00487942|142964836|SUPERIORITY_OR_OTHER||Effect size|0.14|||||TWO_SIDED|95.0|-0.64|0.93||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.93|-0.64|
71724651|NCT00487942|142964837|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-0.99|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-0.99|
71724652|NCT00487942|142964837|SUPERIORITY_OR_OTHER||Effect size|0.34|||||TWO_SIDED|95.0|-0.42|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.42|
71724653|NCT00487942|142964837|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.72|0.85||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.85|-0.72|
71724654|NCT00487942|142964838|SUPERIORITY_OR_OTHER||Effect size|-0.2|||||TWO_SIDED|95.0|-0.95|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-0.95|
71830291|NCT00457743|143165332|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|13.3||||||95.0|3.8|30.7|||||The subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).|||30.7|3.8|
71830292|NCT00457743|143165341|SUPERIORITY_OR_OTHER||CBR rate (percentage)|40.0||||||95.0|22.7|59.4|||||The clinical benefit response (CBR) rate, defined as the percentage of the subjects confirmed with CR, PR, or SD\>=22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).|||59.4|22.7|
71724655|NCT00487942|142964838|SUPERIORITY_OR_OTHER||Effect size|-0.35|||||TWO_SIDED|95.0|-1.11|0.41||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.41|-1.11|
71724656|NCT00487942|142964838|SUPERIORITY_OR_OTHER||Effect size|-0.16|||||TWO_SIDED|95.0|-0.95|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.95|
71724657|NCT00487942|142964839|SUPERIORITY_OR_OTHER||Effect size|-0.51|||||TWO_SIDED|95.0|-1.3|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.30|
71724658|NCT00487942|142964839|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.25|1.35||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.35|-0.25|
71724659|NCT00487942|142964839|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
71724660|NCT00487942|142964840|SUPERIORITY_OR_OTHER||Effect size|-0.64|||||TWO_SIDED|95.0|-1.43|0.15||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.15|-1.43|
71770002|NCT01992159|143039692|SUPERIORITY||Treatment Difference|2.6||||0.0001|ONE_SIDED|95.0|1.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.5|0.0001
71830293|NCT02928224|143165358|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71830294|NCT02928224|143165359|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71724661|NCT00487942|142964840|SUPERIORITY_OR_OTHER||Effect Size|-0.26|||||TWO_SIDED|95.0|-1.05|0.53||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.53|-1.05|
71770003|NCT01992159|143039693|SUPERIORITY||Treatment Difference|1.6||||0.0067|ONE_SIDED|95.0|0.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||0.5|0.0067
71770004|NCT01992159|143039693|SUPERIORITY||Treatment Difference|2.6|||<|0.0001|ONE_SIDED|95.0|1.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||1.6|< 0.0001
71830295|NCT02928224|143165360|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71830296|NCT02928224|143165369|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71830297|NCT02928224|143165370|OTHER|||||||0.5958|||||||Stratified Log-rank|||||||0.5958
71830298|NCT02928224|143165371|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71830299|NCT02928224|143165372|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71830300|NCT02928224|143165373|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71830301|NCT02928224|143165374|OTHER||||||<|0.0001|||||||Stratified Log-rank|||||||<0.0001
71830302|NCT02928224|143165375|OTHER|||||||0.1004|||||||Stratified Log-rank|||||||0.1004
71830303|NCT02928224|143165376|OTHER|||||||0.3724|||||||Stratified Log-rank|||||||0.3724
71830304|NCT02928224|143165377|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71830305|NCT02928224|143165378|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71830306|NCT02928224|143165379|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71830307|NCT02928224|143165380|OTHER|||||||0.1928|||||||Cochran-Mantel-Haenszel|||||||0.1928
71724662|NCT00487942|142964840|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
71724663|NCT00487942|142964841|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.92|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.92|
71724664|NCT00487942|142964841|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.54|1.04||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.04|-0.54|
71724665|NCT00487942|142964841|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.12|0.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.49|-1.12|
71724666|NCT00487942|142964842|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.22|0.33||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.33|-1.22|
71724667|NCT00487942|142964842|SUPERIORITY_OR_OTHER||Effect size|-0.89|||||TWO_SIDED|95.0|-1.69|-0.08||Inferential statistics not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||-0.08|-1.69|
71830308|NCT02928224|143165381|OTHER|||||||0.0357|||||||Cochran-Mantel-Haenszel|||||||0.0357
71724668|NCT00487942|142964842|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.95|0.7||Inferential statistics not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.95|
71724669|NCT00487942|142964888|SUPERIORITY_OR_OTHER||Effect size|0.12|||||TWO_SIDED|95.0|-0.76|1.0||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.0|-0.76|
71724670|NCT00487942|142964888|SUPERIORITY_OR_OTHER||Effect size|-0.33|||||TWO_SIDED|95.0|-1.15|0.48||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.48|-1.15|
71770005|NCT01992159|143039693|SUPERIORITY||Treatment Difference|3.5|||<|0.0001|ONE_SIDED|95.0|2.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|||2.3|< 0.0001
71770006|NCT01992159|143039698|SUPERIORITY||Treatment Difference|-15.3||||0.5084|TWO_SIDED|95.0|-60.8|30.2|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||30.2|-60.8|0.5084
71770007|NCT01992159|143039698|SUPERIORITY||Treatment Difference|84.1||||0.0002|TWO_SIDED|95.0|40.1|128.0|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||128.0|40.1|0.0002
71830309|NCT00468910|143165437|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The study was powered to detect an attributable change in the aspirin group of 50% relative to baseline values - an approximate 50% increase in spectral slope.||||0.11
71830310|NCT00468910|143165438|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.17
71830311|NCT02601170|143165487|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71770008|NCT01992159|143039698|SUPERIORITY||Treatment Difference|153.8|||<|0.0001|TWO_SIDED|95.0|109.2|198.4|||ANCOVA|ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.||||198.4|109.2|< 0.0001
71724671|NCT00487942|142964888|SUPERIORITY_OR_OTHER||Effect size|0.27|||||TWO_SIDED|95.0|-0.61|1.15||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.15|-0.61|
71724672|NCT00487942|142964889|SUPERIORITY_OR_OTHER||Effect size|0.33|||||TWO_SIDED|95.0|-0.58|1.24||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.24|-0.58|
71724673|NCT00487942|142964889|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.91|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.91|
71724674|NCT00487942|142964889|SUPERIORITY_OR_OTHER||Effect size|-0.44|||||TWO_SIDED|95.0|-1.33|0.45||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.33|
71830312|NCT00028093|143165494|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in the outcome between the two groups||||0.54
71830313|NCT02396316|143165546|SUPERIORITY_OR_OTHER||Difference of LS mean change|-4.9||||0.0644|TWO_SIDED|95.0|-10.2|0.3|||ANCOVA|||Point estimate, 95% CI and P-value were based on treatment difference of the LS mean changes using an ANCOVA model with treatment group and stage of NVG for randomization as fixed effects, baseline value as covariate. The superiority of aflibercept injection to sham injection was to be established if the upper limit of the two-sided 95% confidence interval for the difference (the aflibercept group minus the sham group) is less than 0.||0.3|-10.2|0.0644
71830314|NCT02396316|143165547|SUPERIORITY_OR_OTHER||MH adjusted difference|59.1|||||TWO_SIDED|95.0|37.0|81.2|||Mantel Haenszel|||The point estimate of the treatment difference (the aflibercept group minus the sham group) at Week 1 and its two-sided 95% confidence interval stratified by stage of NVG (as randomized) using Mantel-Haenszel weights.||81.2|37.0|
71724675|NCT00487942|142964890|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.75|1.1||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.10|-0.75|
71724676|NCT00487942|142964890|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.98|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.98|
71724677|NCT00487942|142964890|SUPERIORITY_OR_OTHER||Effect size|0.37|||||TWO_SIDED|95.0|-0.54|1.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.27|-0.54|
71770009|NCT04972630|143039726|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0||||||||Baseline control vs. intervention||||
71770010|NCT04972630|143039726|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0||||||||Week 4 control vs. intervention||||
71770011|NCT04972630|143039726|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
71770012|NCT04972630|143039726|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
71770013|NCT04972630|143039727|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
71770014|NCT04972630|143039728|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0||||||||||||
71770015|NCT04972630|143039729|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0||||||||||||
71770016|NCT04972630|143039730|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0||||||||||||
71657719|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
71657720|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71657721|NCT02504671|142831745|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-8.7|14.1|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||14.1|-8.7|
71657722|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
71657723|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|4.5|44.1|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||44.1|4.5|
71657724|NCT02504671|142831745|OTHER||Difference|51.4|||||TWO_SIDED|95.0|32.2|70.5|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.5|32.2|
71657725|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||35.7|2.1|
71657726|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.4|-2.4|
71657727|NCT02504671|142831745|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-7.0|17.8|||||Week 16, ACR70. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||17.8|-7.0|
71657728|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.2|2.0|
71657729|NCT02504671|142831745|OTHER||Difference|43.2|||||TWO_SIDED|95.0|23.5|63.0|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||63.0|23.5|
71657730|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|6.9|41.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||41.8|6.9|
71657731|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|4.5|38.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||38.8|4.5|
71657732|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|3.3|34.5|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.5|3.3|
71657733|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71657734|NCT02504671|142831745|OTHER||Difference|27.0|||||TWO_SIDED|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||46.3|7.7|
71657735|NCT02504671|142831745|OTHER||Difference|45.9|||||TWO_SIDED|95.0|26.7|65.2|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.2|26.7|
71657736|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-3.6|30.6|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||30.6|-3.6|
71657737|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||33.7|-1.2|
71770017|NCT04972630|143039731|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0||||||||||||
71770018|NCT04972630|143039732|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|3.2|||||TWO_SIDED|95.0||||||||||||
71770019|NCT04972630|143039733|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0||||||||||||
71770020|NCT04972630|143039734|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0||||||||||||
71770021|NCT04972630|143039735|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-6.4|||||TWO_SIDED|95.0||||||||||||
71770022|NCT04972630|143039736|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0||||||||||||
71770023|NCT04972630|143039737|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-16.7|||||TWO_SIDED|95.0||||||||||||
71770024|NCT04972630|143039738|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||||||
71770025|NCT04972630|143039739|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
71770026|NCT04972630|143039739|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
71770027|NCT04972630|143039739|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
71770028|NCT04972630|143039739|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
71770029|NCT04972630|143039740|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0||||||||Baseline, control vs. intervention||||
71770030|NCT04972630|143039740|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0||||||||Week 4, control vs. intervention||||
71770031|NCT04972630|143039740|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0||||||||Week 12, control vs. intervention||||
71770032|NCT04972630|143039740|OTHER|Comparison via 95% confidence interval|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0||||||||Week 24, control vs. intervention||||
71724678|NCT00487942|142964891|SUPERIORITY_OR_OTHER||Effect size|-0.38|||||TWO_SIDED|95.0|-1.14|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.14|
71724679|NCT00487942|142964891|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.89|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.89|
71724680|NCT00487942|142964891|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.84|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.84|
71724681|NCT00487942|142964892|SUPERIORITY_OR_OTHER||Effect size|-0.41|||||TWO_SIDED|95.0|-1.21|0.4||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.40|-1.21|
71724682|NCT00487942|142964892|SUPERIORITY_OR_OTHER||Effect size|-0.29|||||TWO_SIDED|95.0|-1.09|0.52||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.52|-1.09|
71724683|NCT00487942|142964892|SUPERIORITY_OR_OTHER||Effect size|-0.69|||||TWO_SIDED|95.0|-1.51|0.14||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.14|-1.51|
71770033|NCT03390842|143039748|SUPERIORITY||Difference in % of subjects|24.9|||=|0.0015|TWO_SIDED|95.0|10.2|38.7|||Fisher Exact|||% Subjects Who Met Endpoint (≥ 4 mEq/L Change from Baseline Serum Bicarbonate or Serum Bicarbonate in the Normal Range \[22 - 29 mEq/L\]): TRC101-Placebo||38.7|10.2|= 0.0015
71770034|NCT03390842|143039748|SUPERIORITY||Treatment difference in % of subjects|24.4|||=|0.0015|TWO_SIDED|95.0|9.7|38.2|||Fisher Exact|||% Subjects with ≥ 4mEq/L Change from Baseline in Serum Bicarbonate: TRC101-Placebo||38.2|9.7|= 0.0015
71770035|NCT03390842|143039748|SUPERIORITY||Treatment difference in % of subjects|30.2|||<|0.0001|TWO_SIDED|95.0|15.6|43.7|||Fisher Exact|||% Subjects with Serum Bicarbonate in Normal Range (22 - 29 mEq/L): TRC101-Placebo||43.7|15.6|< 0.0001
71830315|NCT01154985|143165548|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Armitage trend test|||Proportion of responders in the EPA-E 1800 mg and 2700 mg groups compared to the proportion of responders in the placebo group compared using the Cochran-Armitage trend test in the Efficacy Evaluable analysis set. P-value less than 5% 1-sided. A total sample size of 210 (70 per arm) was planned to give 80% power for detecting a positive dose-response slope among the 3 treatment arms at 12 months.||||0.57
71770036|NCT03390842|143039749|SUPERIORITY||Treatment difference in LS means|1.99|STANDARD_ERROR_OF_MEAN|0.524|=|0.0002|TWO_SIDED|95.0|0.96|3.03|||Mixed-effect repeated measures model||Standard error presented above is for the LS mean.|Least Squares Mean Change from Baseline: TRC101-Placebo||3.03|0.96|= 0.0002
71770037|NCT03390842|143039750|SUPERIORITY||||||<|0.0001||||||p-value based on analysis of covariance model with rank of change from baseline in total score as dependent variable; treatment (PBO or TRC101) as a fixed effect; and baseline total score, Baseline eGFR, Baseline Bicarbonate as continuous covariates.|ANCOVA|||Mean Change from Baseline in KDQOL-PFD: TRC101-Placebo||||< 0.0001
71770038|NCT03390842|143039751|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from Baseline for Repeated Chair Stand Test: TRC101-Placebo||||< 0.0001
71657738|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71770039|NCT01653132|143039785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.194|STANDARD_DEVIATION|0.61|||TWO_SIDED|95.0|-0.71|0.32|||||negative values correspond to a reduction in saliva weight with Inco-A.|Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.||0.32|-0.71|
71770040|NCT01653132|143039786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.3|STANDARD_DEVIATION|0.34|||TWO_SIDED|95.0|-50.8|6.2|||||negative numbers represent reduction in saliva weight with Inco-A|||6.2|-50.8|
71770041|NCT01653132|143039787|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33|STANDARD_DEVIATION|1.41|||TWO_SIDED|95.0|-1.16|0.69|||||negative values represent reduction in scores (improvement in drooling) with Inco-A|||0.69|-1.16|
71770042|NCT01653132|143039788|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.333|||||TWO_SIDED|95.0|-0.633|0.071||||||||0.071|-0.633|
71770043|NCT01653132|143039789|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.11|||||TWO_SIDED|95.0|-0.46|0.28||||||||0.28|-0.46|
71770044|NCT00461331|143039800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|96.4|STANDARD_DEVIATION|8.5||0.52||95.0|87.9|100.0|||Regression, Linear|7 patients underwent early termination of either one or both of their test period due to loss of glycemic control||Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.||100.0|87.9|0.52
71770045|NCT00461331|143039801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.35|STANDARD_DEVIATION|4.165||0.15||95.0|0.97|9.23|||Regression, Linear||This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.23|0.97|0.15
71770046|NCT00461331|143039802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7|STANDARD_DEVIATION|2.35||0.55||95.0|4.4|9.4|||Regression, Linear||This was for test period 1 between days 3 and 5 after the last pump infusion line change.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson's correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.||9.4|4.4|0.55
71770047|NCT03312751|143039803|SUPERIORITY||Overall response rate|62.9||||0.0053|TWO_SIDED|95.0|44.9|78.5|||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||78.5|44.9|0.0053
71770048|NCT03312751|143039803|SUPERIORITY|||||||0.2839|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.2839
71770049|NCT03312751|143039803|SUPERIORITY|||||||0.0031|||||||Exact binomial|||The primary efficacy endpoint was analyzed with an exact binomial test to evaluate the null hypothesis that the Overall Response Rate was, at most, 40%. This test was performed at the one sided 0.025 significance level.||||0.0031
71770050|NCT00046891|143039849|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.||||0.84
71770051|NCT03102190|143039868|OTHER||||||||||||||||||The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.|||
71770052|NCT00402233|143039878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|||<|0.0001||95.0|-6.53|-2.26|||ANCOVA|||||-2.26|-6.53|<0.0001
71830316|NCT01154985|143165549|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.0137
71830317|NCT01154985|143165549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|||||TWO_SIDED|95.0|3.4|29.1||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||29.1|3.4|
71657739|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|-1.1|
71770053|NCT00402233|143039878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|||<|0.0001||95.0|-6.54|-2.28|||ANCOVA|||||-2.28|-6.54|<0.0001
71770054|NCT00402233|143039878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72|||<|0.0001||95.0|-6.91|-2.52|||ANCOVA|||||-2.52|-6.91|<0.0001
71657740|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71770055|NCT00402233|143039879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||||95.0|0.431|1.849|||Regression, Logistic|||||1.849|0.431|
71770056|NCT00402233|143039879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.885||||||95.0|0.424|1.845|||Regression, Logistic|||||1.845|0.424|
71770057|NCT00402233|143039879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||||95.0|0.317|1.492|||Regression, Logistic|||||1.492|0.317|
71770058|NCT00402233|143039880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14||||0.014||95.0|0.23|2.04|||ANCOVA|||||2.04|0.23|0.014
71770059|NCT00402233|143039880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03||95.0|0.094|1.9|||ANCOVA|||||1.9|0.094|0.03
71770060|NCT00402233|143039880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49||||0.0019||95.0|0.56|2.43|||ANCOVA|||||2.43|0.56|0.0019
71770061|NCT00402233|143039881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.39||95.0|-1.82|0.71|||ANCOVA|||||0.71|-1.82|0.39
71770062|NCT00402233|143039881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.37||95.0|-1.84|0.69|||ANCOVA|||||0.69|-1.84|0.37
71770063|NCT00402233|143039881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.48||95.0|-1.78|0.84|||ANCOVA|||||0.84|-1.78|0.48
71770064|NCT04721067|143039915|SUPERIORITY||Mean Difference (Net)|-2.27||||0.607|TWO_SIDED|95.0|-15.14|10.6|||Regression, Logistic|Adjusted for baseline values||||10.60|-15.14|0.607
71770065|NCT04721067|143039916|SUPERIORITY||Mean Difference (Net)|-2.99||||0.766|TWO_SIDED|95.0|-10.74|4.76|||ANCOVA|||||4.76|-10.74|0.766
71770066|NCT04721067|143039917|SUPERIORITY||Mean Difference (Net)|145.54||||0.465|TWO_SIDED|95.0|-264.05|555.14|||ANCOVA|||||555.14|-264.05|0.465
71770067|NCT04721067|143039918|SUPERIORITY||Mean Difference (Net)|137.79||||0.178|TWO_SIDED|95.0|-68.71|344.3|||ANCOVA|||||344.30|-68.71|0.178
71770068|NCT04721067|143039919|SUPERIORITY||Mean Difference (Net)|1.87||||0.548|TWO_SIDED|95.0|-4.58|8.31|||ANCOVA|||||8.31|-4.58|0.548
71770069|NCT04721067|143039920|SUPERIORITY||Mean Difference (Net)|-0.67||||0.579|TWO_SIDED|95.0|-3.14|1.8|||ANCOVA|||||1.80|-3.14|0.579
71657741|NCT02504671|142831745|OTHER||Difference|64.9|||||TWO_SIDED|95.0|48.9|80.8|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||80.8|48.9|
71724684|NCT00487942|142964893|SUPERIORITY_OR_OTHER||Effect size|-0.24|||||TWO_SIDED|95.0|-1.06|0.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.58|-1.06|
71724685|NCT00487942|142964893|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.85|0.75||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.75|-0.85|
71724686|NCT00487942|142964893|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.9|0.7||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.70|-0.90|
71724687|NCT00487942|142964896|SUPERIORITY_OR_OTHER||Effect size|-0.05|||||TWO_SIDED|95.0|-0.8|0.71||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.71|-0.80|
71724688|NCT00487942|142964896|SUPERIORITY_OR_OTHER||Effect size|-0.31|||||TWO_SIDED|95.0|-1.06|0.45||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.45|-1.06|
71724689|NCT00487942|142964896|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.68|0.89||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.68|
71724690|NCT00487942|142964897|SUPERIORITY_OR_OTHER||Effect size|-0.13|||||TWO_SIDED|95.0|-0.88|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.88|
71770070|NCT04721067|143039921|SUPERIORITY||Mean Difference (Net)|-0.63||||0.766|TWO_SIDED|95.0|-5.0|3.74|||ANCOVA|||||3.74|-5.00|0.766
71770071|NCT04721067|143039922|SUPERIORITY||Mean Difference (Net)|-1.23||||0.42|TWO_SIDED|95.0|-4.39|1.93|||ANCOVA|||||1.93|-4.39|0.42
71770072|NCT04721067|143039923|SUPERIORITY||Mean Difference (Net)|-0.07||||0.91|TWO_SIDED|95.0|-1.34|1.2|||ANCOVA|||||1.20|-1.34|0.91
71770073|NCT04721067|143039924|SUPERIORITY||Mean Difference (Net)|0.79||||0.73|TWO_SIDED|95.0|-4.03|5.6|||ANCOVA|||||5.60|-4.03|0.73
71770074|NCT04721067|143039925|SUPERIORITY||Mean Difference (Net)|0.19||||0.42|TWO_SIDED|95.0|-0.3|0.68|||ANCOVA|||||0.68|-0.30|0.42
71770075|NCT04721067|143039926|SUPERIORITY||Mean Difference (Net)|1.79||||0.18|TWO_SIDED|95.0|-0.9|4.48|||ANCOVA|||||4.48|-0.90|0.18
71770076|NCT04721067|143039927|SUPERIORITY||Mean Difference (Net)|-2.03||||0.48|TWO_SIDED|95.0|-7.97|3.9|||ANCOVA|||||3.90|-7.97|0.48
71770077|NCT04721067|143039928|SUPERIORITY||Mean Difference (Net)|1.42||||0.08|TWO_SIDED|95.0|-0.24|3.08|||ANCOVA|||||3.08|-0.24|0.08
71770078|NCT04721067|143039929|SUPERIORITY||Mean Difference (Net)|0.51||||0.94|TWO_SIDED|95.0|-13.5|14.52|||ANCOVA|||||14.52|-13.50|0.94
71770079|NCT04721067|143039932|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.32|TWO_SIDED|95.0|-0.45|1.32|||t-test, 2 sided|||||1.32|-0.45|0.32
71770080|NCT04721067|143039933|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.61|TWO_SIDED|95.0|-0.75|1.25|||t-test, 2 sided|||||1.25|-0.75|0.61
71770081|NCT04721067|143039934|SUPERIORITY||Mean Difference (Net)|-1.05||||0.52|TWO_SIDED|95.0|-4.42|2.31|||ANCOVA|||||2.31|-4.42|0.52
71770082|NCT04721067|143039935|SUPERIORITY||Mean Difference (Net)|-0.44||||0.61|TWO_SIDED|95.0|-2.2|1.32|||ANCOVA|||||1.32|-2.20|0.61
71770083|NCT04721067|143039936|SUPERIORITY||Mean Difference (Net)|3.68||||0.16|TWO_SIDED|95.0|-1.61|8.97|||ANCOVA|||||8.97|-1.61|0.16
71770084|NCT04721067|143039937|SUPERIORITY||Mean Difference (Net)|0.43||||0.13|TWO_SIDED|95.0|-0.13|1.0|||ANCOVA|||||1.00|-0.13|0.13
71770085|NCT04721067|143039938|SUPERIORITY||Mean Difference (Net)|3.88||||0.03|TWO_SIDED|95.0|0.35|7.41|||ANCOVA|||||7.41|0.35|0.03
71770086|NCT04721067|143039939|SUPERIORITY||Mean Difference (Net)|-3.2||||0.41|TWO_SIDED|95.0|-11.07|4.66|||ANCOVA|||||4.66|-11.07|0.41
71770087|NCT04721067|143039940|SUPERIORITY||Mean Difference (Net)|1.7||||0.17|TWO_SIDED|95.0|-0.83|4.22|||ANCOVA|||||4.22|-0.83|0.17
71770088|NCT04721067|143039941|SUPERIORITY||Mean Difference (Net)|3.49||||0.58|TWO_SIDED|95.0|-9.58|16.55|||ANCOVA|||||16.55|-9.58|0.58
71724691|NCT00487942|142964897|SUPERIORITY_OR_OTHER||Effect size|0.05|||||TWO_SIDED|95.0|-0.72|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.72|
71724692|NCT00487942|142964897|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.81||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.81|-0.80|
71724693|NCT00487942|142964898|SUPERIORITY_OR_OTHER||Effect size|-0.62|||||TWO_SIDED|95.0|-1.44|0.2||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.20|-1.44|
71724694|NCT00487942|142964898|SUPERIORITY_OR_OTHER||Effect size|-0.18|||||TWO_SIDED|95.0|-0.98|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.98|
71724695|NCT00487942|142964898|SUPERIORITY_OR_OTHER||Effect size|-0.17|||||TWO_SIDED|95.0|-0.97|0.63||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.63|-0.97|
71724696|NCT00487942|142964899|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
71724697|NCT00487942|142964899|SUPERIORITY_OR_OTHER||Effect size|-0.08|||||TWO_SIDED|95.0|-0.88|0.72||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.72|-0.88|
71770089|NCT04721067|143039942|SUPERIORITY||Mean Difference (Net)|0.15||||0.74|TWO_SIDED|95.0|-0.79|1.1|||ANCOVA|||||1.10|-0.79|0.74
71724698|NCT00487942|142964899|SUPERIORITY_OR_OTHER||Effect size|0.08|||||TWO_SIDED|95.0|-0.72|0.89||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.89|-0.72|
71770090|NCT04721067|143039943|SUPERIORITY||Mean Difference (Net)|129.077||||0.17|TWO_SIDED|95.0|-57.78|315.92|||ANCOVA|||||315.92|-57.78|0.17
71770091|NCT04721067|143039944|SUPERIORITY||Mean Difference (Net)|109.71||||0.31|TWO_SIDED|95.0|-108.37|327.78|||ANCOVA|||||327.78|-108.37|0.31
71770092|NCT04721067|143039945|SUPERIORITY||Mean Difference (Net)|0.24||||0.92|TWO_SIDED|95.0|-4.52|5.0|||ANCOVA|||||5.00|-4.52|0.92
71770093|NCT04721067|143039946|SUPERIORITY||Mean Difference (Net)|-1.11||||0.66|TWO_SIDED|95.0|-6.28|4.06|||ANCOVA|||||4.06|-6.28|0.66
71770094|NCT02233478|143039947|OTHER||Mean Difference (Final Values)|0.001||||0.82|TWO_SIDED||||||t-test, 2 sided|||"Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.~Due to the quality issue of soybean flour, data from this intervention group was not analyzed."||||0.82
71770095|NCT00873873|143039950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANOVA|||Is there a difference in airway wall thickness among the 4 groups?||||0.2
71770096|NCT00604214|143039961|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.313|TWO_SIDED|95.0|0.923|1.283||No adjustment for multiple comparisons.|Chi-squared|||The study was planned to have 80% power to detect a 20% relative risk reduction in 28-day all-cause mortality in drotrecogin alpha (activated) compared to placebo. The final power was 75% because of the lower than anticipated placebo mortality.||1.283|0.923|0.313
71770097|NCT00604214|143039962|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.54|TWO_SIDED|95.0|0.737|1.173||No adjustments for multiple comparisons.|Chi-squared|||||1.173|0.737|0.540
71770098|NCT00604214|143039963|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.181
71770099|NCT00604214|143039964|SUPERIORITY_OR_OTHER|||||||0.733||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.733
71770100|NCT00604214|143039965|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||No adjustments for multiple comparisons.|ANOVA|||||||0.122
71770101|NCT00604214|143039966|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.042||||0.556|TWO_SIDED|95.0|0.909|1.193||No adjustments for multiple comparisons.|Chi-squared|||||1.193|0.909|0.556
71724699|NCT00487942|142964900|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.65|0.87||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.65|
71724700|NCT00487942|142964900|SUPERIORITY_OR_OTHER||Effect size|0.13|||||TWO_SIDED|95.0|-0.63|0.88||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.88|-0.63|
71724701|NCT00487942|142964900|SUPERIORITY_OR_OTHER||Effect size|1.69|||||TWO_SIDED|95.0|0.78|2.6||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.60|0.78|
71724702|NCT00487942|142964901|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.06|0.46||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.46|-1.06|
71724703|NCT00487942|142964901|SUPERIORITY_OR_OTHER||Effect size|-0.1|||||TWO_SIDED|95.0|-0.87|0.67||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.67|-0.87|
71770102|NCT00604214|143039967|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.758|TWO_SIDED|95.0|0.898|1.16||No adjustments for multiple comparisons.|Chi-squared|||||1.160|0.898|0.758
71888069|NCT01890421|143296983|SUPERIORITY||Sensitivity Difference|-0.7||||0.8694|ONE_SIDED|95.0|-8.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||-8.5|0.8694
71724704|NCT00487942|142964901|SUPERIORITY_OR_OTHER||Effect size|0.89|||||TWO_SIDED|95.0|0.05|1.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.74|0.05|
71770103|NCT00604214|143039969|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.788
71770104|NCT00604214|143039969|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.730
71770105|NCT00604214|143039969|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.662
71770106|NCT00604214|143039969|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.846
71770107|NCT00604214|143039970|SUPERIORITY_OR_OTHER|||||||0.697||95.0||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA|||||||0.697
71770108|NCT00604214|143039970|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA|||||||0.306
71770109|NCT00604214|143039970|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA|||||||0.645
71770110|NCT00604214|143039970|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA|||||||0.690
71770111|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value is for physical component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.482
71770112|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||P-value is for physical component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.584
71770113|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for physical component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.164
71770114|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||P-value is for physical component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.666
71770115|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.786||95.0||||P-value is for mental component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.786
71770116|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for mental component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.160
71724705|NCT00487942|142964902|SUPERIORITY_OR_OTHER||Effect size|-0.25|||||TWO_SIDED|95.0|-1.05|0.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.55|-1.05|
71724706|NCT00487942|142964902|SUPERIORITY_OR_OTHER||Effect size|0.29|||||TWO_SIDED|95.0|-0.52|1.09||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.09|-0.52|
71724707|NCT00487942|142964902|SUPERIORITY_OR_OTHER||Effect size|0.75|||||TWO_SIDED|95.0|-0.08|1.58||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.58|-0.08|
71724708|NCT00487942|142964903|SUPERIORITY_OR_OTHER||Effect size|0.02|||||TWO_SIDED|95.0|-0.78|0.82||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.82|-0.78|
71724709|NCT00487942|142964903|SUPERIORITY_OR_OTHER||Effect size|0.55|||||TWO_SIDED|95.0|-0.27|1.36||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.36|-0.27|
71724710|NCT00487942|142964903|SUPERIORITY_OR_OTHER||Effect size|1.62|||||TWO_SIDED|95.0|0.7|2.55||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||2.55|0.70|
71724711|NCT00487942|142964904|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
71724712|NCT00487942|142964904|SUPERIORITY_OR_OTHER||Effect size|-0.11|||||TWO_SIDED|95.0|-0.87|0.64||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.64|-0.87|
71724713|NCT00487942|142964904|SUPERIORITY_OR_OTHER||Effect size|0.73|||||TWO_SIDED|95.0|-0.08|1.54||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.54|-0.08|
71724714|NCT00487942|142964905|SUPERIORITY_OR_OTHER||Effect size|-0.5|||||TWO_SIDED|95.0|-1.27|0.27||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.27|-1.27|
71724715|NCT00487942|142964905|SUPERIORITY_OR_OTHER||Effect size|-0.28|||||TWO_SIDED|95.0|-1.05|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.05|
71724716|NCT00487942|142964905|SUPERIORITY_OR_OTHER||Effect size|0.3|||||TWO_SIDED|95.0|-0.51|1.11||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.11|-0.51|
71657742|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71724717|NCT00487942|142964906|SUPERIORITY_OR_OTHER||Effect size|-0.12|||||TWO_SIDED|95.0|-0.92|0.68||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.68|-0.92|
71724718|NCT00487942|142964906|SUPERIORITY_OR_OTHER||Effect size|0.07|||||TWO_SIDED|95.0|-0.73|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.73|
71724719|NCT00487942|142964906|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.77|0.83||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.83|-0.77|
71724720|NCT00487942|142964907|SUPERIORITY_OR_OTHER||Effect size|0.0|||||TWO_SIDED|95.0|-0.8|0.8||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.80|-0.80|
71724721|NCT00487942|142964907|SUPERIORITY_OR_OTHER||Effect size|0.18|||||TWO_SIDED|95.0|-0.62|0.98||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.98|-0.62|
71724722|NCT00487942|142964907|SUPERIORITY_OR_OTHER||Effect size|0.66|||||TWO_SIDED|95.0|-0.16|1.49||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.49|-0.16|
71770117|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value is for mental component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.696
71770118|NCT00604214|143039971|SUPERIORITY_OR_OTHER|||||||0.966||95.0||||P-value is for mental component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.||||0.966
71770119|NCT00604214|143039972|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||P-value is for participants with ≥1 event. No adjustments for multiple comparisons.|Fisher Exact|||||||0.758
71770120|NCT00604214|143039973|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Unadjusted for multiple comparisons.|Fisher Exact|||||||0.154
71770121|NCT04445792|143039981|SUPERIORITY|||||||0.7195|||||||Wilcoxon (Mann-Whitney)|||||||0.7195
71770122|NCT04445792|143039981|SUPERIORITY|||||||0.8054|||||||Wilcoxon (Mann-Whitney)|||||||0.8054
71770123|NCT04445792|143039981|SUPERIORITY|||||||0.861|||||||Wilcoxon (Mann-Whitney)|||||||0.861
71770124|NCT04445792|143039982|SUPERIORITY|||||||0.4385|||||||Wilcoxon (Mann-Whitney)|||||||0.4385
71770125|NCT04445792|143039982|SUPERIORITY|||||||0.7185|||||||Wilcoxon (Mann-Whitney)|||||||0.7185
71770126|NCT04445792|143039982|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
71770127|NCT04445792|143039983|SUPERIORITY|||||||0.9222|||||||Wilcoxon (Mann-Whitney)|||||||0.9222
71770128|NCT04445792|143039983|SUPERIORITY|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||||||0.1918
71770129|NCT04445792|143039983|SUPERIORITY|||||||0.0119|||||||Wilcoxon (Mann-Whitney)|||||||0.0119
71770130|NCT04445792|143039984|SUPERIORITY|||||||0.6971|||||||Wilcoxon (Mann-Whitney)|||||||0.6971
71770131|NCT04445792|143039984|SUPERIORITY|||||||0.2309|||||||Wilcoxon (Mann-Whitney)|||||||0.2309
71770132|NCT04445792|143039984|SUPERIORITY|||||||0.0441|||||||Wilcoxon (Mann-Whitney)|||||||0.0441
71770133|NCT04445792|143039985|SUPERIORITY|||||||0.7988|||||||Wilcoxon (Mann-Whitney)|||||||0.7988
71770134|NCT04445792|143039985|SUPERIORITY|||||||0.0483|||||||Wilcoxon (Mann-Whitney)|||||||0.0483
71770135|NCT04445792|143039985|SUPERIORITY|||||||0.0104|||||||Wilcoxon (Mann-Whitney)|||||||0.0104
71770136|NCT04445792|143039986|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
71770137|NCT04445792|143039986|SUPERIORITY|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||||||0.2348
71770138|NCT04445792|143039986|SUPERIORITY|||||||0.0517|||||||Wilcoxon (Mann-Whitney)|||||||0.0517
71770139|NCT04445792|143039987|SUPERIORITY|||||||0.6835|||||||Wilcoxon (Mann-Whitney)|||||||0.6835
71770140|NCT04445792|143039987|SUPERIORITY|||||||0.0205|||||||Wilcoxon (Mann-Whitney)|||||||0.0205
71770141|NCT04445792|143039987|SUPERIORITY|||||||0.0036|||||||Wilcoxon (Mann-Whitney)|||||||0.0036
71770142|NCT04445792|143039988|SUPERIORITY|||||||0.5878|||||||Wilcoxon (Mann-Whitney)|||||||0.5878
71770143|NCT04445792|143039988|SUPERIORITY|||||||0.1051|||||||Wilcoxon (Mann-Whitney)|||||||0.1051
71770144|NCT04445792|143039988|SUPERIORITY|||||||0.0292|||||||Wilcoxon (Mann-Whitney)|||||||0.0292
71770145|NCT04445792|143039989|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71770146|NCT04445792|143039989|SUPERIORITY|||||||0.5973|||||||Chi-squared|||||||0.5973
71724723|NCT00487942|142964908|SUPERIORITY_OR_OTHER||Effect size|0.25|||||TWO_SIDED|95.0|-0.51|1.01||Inferential statistics were not performed||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||1.01|-0.51|
71724724|NCT00487942|142964908|SUPERIORITY_OR_OTHER||Effect size|0.03|||||TWO_SIDED|95.0|-0.73|0.78||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.78|-0.73|
71724725|NCT00487942|142964908|SUPERIORITY_OR_OTHER||Effect size|-0.23|||||TWO_SIDED|95.0|-1.01|0.56||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.56|-1.01|
71724726|NCT00487942|142964909|SUPERIORITY_OR_OTHER||Effect size|0.11|||||TWO_SIDED|95.0|-0.64|0.87||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.87|-0.64|
71724727|NCT00487942|142964909|SUPERIORITY_OR_OTHER||Effect size|-0.02|||||TWO_SIDED|95.0|-0.79|0.74||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.74|-0.79|
71724728|NCT00487942|142964909|SUPERIORITY_OR_OTHER||Effect size|-0.3|||||TWO_SIDED|95.0|-1.11|0.5||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.50|-1.11|
71724729|NCT00487942|142964910|SUPERIORITY_OR_OTHER||Effect size|-0.15|||||TWO_SIDED|95.0|-0.95|0.65||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.65|-0.95|
71724730|NCT00487942|142964910|SUPERIORITY_OR_OTHER||Effect size|-0.07|||||TWO_SIDED|95.0|-0.87|0.73||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.73|-0.87|
71724731|NCT00487942|142964910|SUPERIORITY_OR_OTHER||Effect size|-0.43|||||TWO_SIDED|95.0|-1.24|0.38||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.38|-1.24|
71724732|NCT00487942|142964911|SUPERIORITY_OR_OTHER||Effect size|0.06|||||TWO_SIDED|95.0|-0.75|0.86||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.86|-0.75|
71724733|NCT00487942|142964911|SUPERIORITY_OR_OTHER||Effect size|-0.19|||||TWO_SIDED|95.0|-0.99|0.62||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.62|-0.99|
71770147|NCT04445792|143039989|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
71770148|NCT02233946|143039995|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.47|1.02||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.02|0.47|
71830318|NCT01154985|143165549|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0006
71724734|NCT00487942|142964911|SUPERIORITY_OR_OTHER||Effect size|-0.47|||||TWO_SIDED|95.0|-1.28|0.34||Inferential statistics were not performed.||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.||0.34|-1.28|
71724735|NCT03040011|142964963|SUPERIORITY|||||||0.39|||||||Kruskal-Wallis|||||||0.39
71724736|NCT03040011|142964964|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||||||0.25
71724737|NCT03040011|142964965|SUPERIORITY|||||||0.17|||||||Kruskal-Wallis|||||||0.17
71724738|NCT03040011|142964966|SUPERIORITY|||||||0.45|||||||Kruskal-Wallis|||||||0.45
71724739|NCT03040011|142964967|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||0.54
71724740|NCT03040011|142964968|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.80
71724741|NCT03040011|142964969|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71724742|NCT03040011|142964970|SUPERIORITY|||||||0.64|||||||Chi-squared|||||||0.64
71724743|NCT03040011|142964971|SUPERIORITY|||||||0.41|||||||Kruskal-Wallis|||||||0.41
71724744|NCT03040011|142964973|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
71770149|NCT02233946|143039995|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.57|1.31||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.31|0.57|
71770150|NCT02233946|143039996|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.4|1.1||||||Participants who reported past-12-month use of alcohol or other drugs at baseline||1.10|0.40|
71770151|NCT02233946|143039997|SUPERIORITY|Participants who reported past-12-month use of alcohol or other drugs at baseline|Cox Proportional Hazard|0.62|||||TWO_SIDED|95.0|0.41|0.94||||||||0.94|0.41|
71657743|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|6.8|36.4|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||36.4|6.8|
71724745|NCT03040011|142964974|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
71724746|NCT03040011|142964975|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
71724747|NCT03040011|142964976|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
71724748|NCT03040011|142964977|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
71724749|NCT03040011|142964978|SUPERIORITY|||||||0.32|||||||Kruskal-Wallis|||||||0.32
71724750|NCT03040011|142964979|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
71724751|NCT03040011|142964980|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
71724752|NCT03040011|142964981|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.40
71724753|NCT03040011|142964982|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
71724754|NCT00678535|142964995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.3158||95.0|0.92|1.292|||Stratified log rank||Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, α=5%).||1.292|0.920|0.3158
71724755|NCT00678535|142964996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9547||95.0|0.866|1.165|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo-) adjuvant(radio) chemotherapy, α=5%)||1.165|0.866|0.9547
71724756|NCT00678535|142964997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0435||||0.7696||95.0|0.7844|1.3882|||Cochran-Mantel-Haenszel|||The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo-) adjuvant(radio) chemotherapy, two-sided with α=5%).||1.3882|0.7844|0.7696
71724757|NCT02578680|142965045|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|1e-05|TWO_SIDED|95.0|0.43|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.43|<0.00001
71724758|NCT02578680|142965046|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.38|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.64|0.38|<0.00001
71724759|NCT02578680|142965047|SUPERIORITY||Difference in Percentage vs. Control|28.5|||<|0.0001|TWO_SIDED|95.0|21.1|35.4||H0:Difference in percentages=0 vs H1:Difference in percentages\>0|Stratified Miettinen and Nurminen||Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||35.4|21.1|<0.0001
71770152|NCT02233946|143039997|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.44|1.32||||||Participants who reported no past-12-month use of alcohol or other drugs at baseline||1.32|0.44|
71770153|NCT02233946|143039998|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.5|1.34||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.34|0.50|
71770154|NCT02233946|143039998|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||1.19|0.44|
71724760|NCT02578680|142965051|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|1e-05|TWO_SIDED|95.0|0.41|0.59|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. \<1%), platinum chemotherapy (cisplatin vs. carboplatin) \& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.|||0.59|0.41|<0.00001
71724761|NCT00664560|142965097|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-4.76|4.32|||ANCOVA|||||4.32|-4.76|
71724762|NCT00664560|142965098|NON_INFERIORITY_OR_EQUIVALENCE|10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-4.57|4.38|||ANCOVA|||||4.38|-4.57|
71724763|NCT00664560|142965099|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-5.08|4.14|||ANCOVA|||||4.14|-5.08|
71724764|NCT02456636|142965109|SUPERIORITY||Mean Difference (Net)|-1.87||||0.025|TWO_SIDED|97.5|-3.51|-0.23|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling)||-0.23|-3.51|.025
71724765|NCT02456636|142965109|SUPERIORITY||Mean Difference (Net)|-1.36||||0.25|TWO_SIDED|97.5|-3.0|0.29|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.29|-3.00|0.25
71724766|NCT02456636|142965109|SUPERIORITY||Mean Difference (Net)|-0.51||||0.025|TWO_SIDED|97.5|-2.15|1.13|||Mixed Models Analysis|||PCMH (in clinic group visits) versus DM (phone group visits)||1.13|-2.15|.025
71724767|NCT02456636|142965110|SUPERIORITY||Median Difference (Net)|-1.84||||0.025|TWO_SIDED|97.5|-3.5|-0.18|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus FFS (in clinic individual counseling).||-0.18|-3.50|.025
71724768|NCT02456636|142965110|SUPERIORITY||Median Difference (Net)|-1.34||||0.025|TWO_SIDED|97.5|-2.99|0.32|||Mixed Models Analysis|||DM (phone group counseling) versus FFS (in clinic individual counseling)||0.32|-2.99|.025
71724769|NCT02456636|142965110|SUPERIORITY||Mean Difference (Net)|-0.5||||0.025|TWO_SIDED|97.5|-2.15|1.15|||Mixed Models Analysis|||PCMH (in clinic group counseling) versus DM (phone group counseling)||1.15|-2.15|.025
71657744|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71724770|NCT03576066|142965129|OTHER|||||||0.6855|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.6855
71724771|NCT03576066|142965129|OTHER|||||||0.175|||||||Repeated measures analysis|||LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.1750
71724772|NCT03576066|142965130|OTHER|||||||0.2916|||||||Repeated measures analysis|||Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24||||0.2916
71724773|NCT02642393|142965158|OTHER||Slope|1.256|STANDARD_ERROR_OF_MEAN|0.943||0.183|TWO_SIDED|95.0|-0.594|3.106|||Mixed Models Analysis|||||3.106|-0.594|0.183
71724774|NCT02642393|142965159|OTHER||Rate Ratio|1.08||||0.124|TWO_SIDED|95.0|0.979|1.192|||Poisson Regression|||||1.192|0.979|0.124
71724775|NCT02642393|142965160|OTHER||Rate Ratio|1.154||||0.004|TWO_SIDED|95.0|1.046|1.273|||Poisson Regression|||||1.273|1.046|0.004
71724776|NCT02642393|142965161|OTHER|||||||0.002|||||||Log Rank|||||||0.002
71724777|NCT02642393|142965162|OTHER|||||||0.497|||||||Log Rank|||||||0.497
71724778|NCT02642393|142965163|OTHER||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.385||0.856|TWO_SIDED|95.0|-0.825|0.685|||Mixed Models Analysis|||||0.685|-0.825|0.856
71724779|NCT02642393|142965164|OTHER||Slope|0.076|STANDARD_ERROR_OF_MEAN|0.226||0.736|TWO_SIDED|95.0|-0.368|0.521|||Mixed Models Analysis|||Anxiety||0.521|-0.368|0.736
71724780|NCT02642393|142965164|OTHER||Slope|0.295|STANDARD_ERROR_OF_MEAN|0.213||0.167|TWO_SIDED|95.0|-0.124|0.714|||Mixed Models Analysis|||Cognitive Function||0.714|-0.124|0.167
71724781|NCT02642393|142965164|OTHER||Slope|0.256|STANDARD_ERROR_OF_MEAN|0.111||0.022|TWO_SIDED|95.0|0.038|0.474|||Mixed Models Analysis|||Communication||0.474|0.038|0.022
71724782|NCT02642393|142965164|OTHER||Slope|0.095|STANDARD_ERROR_OF_MEAN|0.173||0.584|TWO_SIDED|95.0|-0.245|0.435|||Mixed Models Analysis|||Emotional and Behavioral Dyscontrol||0.435|-0.245|0.584
71724783|NCT02642393|142965164|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.28||0.973|TWO_SIDED|95.0|-0.56|0.541|||Mixed Models Analysis|||Fatigue||0.541|-0.560|0.973
71724784|NCT02642393|142965164|OTHER||Slope|0.169|STANDARD_ERROR_OF_MEAN|0.136||0.214|TWO_SIDED|95.0|-0.098|0.437|||Mixed Models Analysis|||Lower Extremity Function||0.437|-0.098|0.214
71724785|NCT02642393|142965164|OTHER||Slope|-0.334|STANDARD_ERROR_OF_MEAN|0.304||0.271|TWO_SIDED|95.0|-0.931|0.262|||Mixed Models Analysis|||Positive Affect and Well-Being||0.262|-0.931|0.271
71724786|NCT02642393|142965164|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|95.0|-0.355|0.194|||Mixed Models Analysis|||Stigma||0.194|-0.355|0.566
71724787|NCT02642393|142965164|OTHER||Slope|0.212|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.063|0.487|||Mixed Models Analysis|||Upper Extremity Function||0.487|-0.063|0.130
71724788|NCT02642393|142965164|OTHER||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.202||0.723|TWO_SIDED|95.0|-0.325|0.468|||Mixed Models Analysis|||Sleep Disturbance||0.468|-0.325|0.723
71724789|NCT02642393|142965164|OTHER||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.298||0.984|TWO_SIDED|95.0|-0.592|0.579|||Mixed Models Analysis|||Satisfaction with Social Roles and Activities||0.579|-0.592|0.984
71724790|NCT02642393|142965164|OTHER||Slope|-0.253|STANDARD_ERROR_OF_MEAN|0.317||0.426|TWO_SIDED|95.0|-0.877|0.371|||Mixed Models Analysis|||Participation in Social Roles and Activities||0.371|-0.877|0.426
71724791|NCT02642393|142965165|OTHER||Slope|-0.106|STANDARD_ERROR_OF_MEAN|0.141||0.454|TWO_SIDED|95.0|-0.382|0.171|||Mixed Models Analysis|||||0.171|-0.382|0.454
71724792|NCT02642393|142965166|OTHER||Slope|0.047|STANDARD_ERROR_OF_MEAN|0.413||0.91|TWO_SIDED|95.0|-0.764|0.858|||Mixed Models Analysis|||||0.858|-0.764|0.910
71724793|NCT02642393|142965167|OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.758|TWO_SIDED|95.0|-0.295|0.215|||Mixed Models Analysis|||||0.215|-0.295|0.758
71724794|NCT02642393|142965168|OTHER||Slope|-0.208|STANDARD_ERROR_OF_MEAN|0.803||0.796|TWO_SIDED|95.0|-1.783|1.367|||Mixed Models Analysis|||BL to V01||1.367|-1.783|0.796
71724795|NCT02642393|142965168|OTHER||Slope|-2.4|STANDARD_ERROR_OF_MEAN|3.443||0.486|TWO_SIDED|95.0|-9.156|4.355|||Mixed Models Analysis|||V10 to SV||4.355|-9.156|0.486
71830319|NCT01154985|143165549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||||TWO_SIDED|95.0|9.6|34.4||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||34.4|9.6|
71830320|NCT01154985|143165550|SUPERIORITY_OR_OTHER|||||||0.1592|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||||0.1592
71830321|NCT01154985|143165550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||||TWO_SIDED|95.0|-3.8|23.0||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.||23.0|-3.8|
71830322|NCT01154985|143165550|SUPERIORITY_OR_OTHER|||||||0.0153|TWO_SIDED|||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||||0.0153
71830323|NCT01154985|143165550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|3.1|28.9||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.||28.9|3.1|
71830324|NCT00566735|143165552|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|Degrees of freedom = 28||Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).||||<0.05
71830325|NCT00925587|143165555|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.5 g/dL|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.427|0.052|||||Darbepoetin alfa QM - Darbepoetin alfa Q2W|Power = 90% at sample size calculation||0.052|-0.427|
71830326|NCT01925469|143165618|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.||An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.||||0.43
71830327|NCT01925469|143165619|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman's correlation coefficient.||||0.4
71830328|NCT01925469|143165620|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71888070|NCT01890421|143296983|SUPERIORITY||Sensitivity Difference|29.1|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||21.7|<0.0001
71830329|NCT00773370|143165621|SUPERIORITY_OR_OTHER||difference between slopes|8.43|STANDARD_DEVIATION|7.17|<|0.25|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||<0.25
71888071|NCT01890421|143296983|SUPERIORITY||Sensitivity Difference|24.1|||<|0.0001|ONE_SIDED|95.0|16.6||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||16.6|<0.0001
71830330|NCT00773370|143165621|SUPERIORITY_OR_OTHER||Slope|14.95|STANDARD_DEVIATION|4.92|<|0.004|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||<0.004
71830331|NCT00773370|143165621|SUPERIORITY_OR_OTHER||Slope|6.52|STANDARD_DEVIATION|5.13||0.218|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.218
71830332|NCT00773370|143165622|SUPERIORITY_OR_OTHER||Difference between slopes|0.186|STANDARD_DEVIATION|0.256||0.47|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.47
71830333|NCT00773370|143165622|SUPERIORITY_OR_OTHER||Slope|0.215|STANDARD_DEVIATION|0.175||0.225|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.225
71830334|NCT00773370|143165622|SUPERIORITY_OR_OTHER||Slope|0.029|STANDARD_DEVIATION|0.187||0.88|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.88
71830335|NCT00773370|143165623|SUPERIORITY_OR_OTHER||Difference between slopes|0.002|STANDARD_DEVIATION|0.078||0.98|TWO_SIDED|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA|||||||.98
71830336|NCT00773370|143165623|SUPERIORITY_OR_OTHER||Slope|0.033|STANDARD_DEVIATION|0.054||0.54|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.54
71830337|NCT00773370|143165623|SUPERIORITY_OR_OTHER||Slope|0.031|STANDARD_DEVIATION|0.057||0.59|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time||||.59
71724796|NCT00365105|142965181|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.844|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||Assuming an exponential distribution, the weighted yearly SRE hazard rate for patients treated with bisphosphonates only is 0.7991 which translates to a median time to SRE of 10.4 months. The study was designed to show a 33% relative reduction in the yearly SRE hazard rate, i.e. 15.6 months median time to SRE. Using a two-sided log-rank test assuming a type I error of 0.05, one planned interim analysis with 90% statistical power, 257 SREs are required with a total of 316 patients.||1.54|0.70|0.844
71724797|NCT00365105|142965182|SUPERIORITY|The power of detecting an improvement from 55% in the control arm to 41% in the experimental arm with a two-sided Fisher's exact test at alpha 0.05 is 66%.||||||0.26|||||||Fisher Exact|||||||0.26
71724798|NCT00365105|142965183|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.37|TWO_SIDED|95.0|0.86|1.52|||Log Rank|||Assuming the disease site distribution is 40%, 40%, and 20% from prostate, breast, and lung cancer populations, respectively, the weighted yearly death rate for patients treated with bisphosphonates only is 0.4390, translating to a median overall survival time of 18.9 months assuming an exponential distribution. Statistical power to detect a relative difference of 33% in the yearly death rate is 70% using a two-sided log-rank test at a 0.05 significance level and 87% to detect 50% difference.||1.52|0.86|0.37
71724799|NCT00365105|142965184|SUPERIORITY|||||||0.96||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||FACT-G Total||||0.96
71724800|NCT00365105|142965184|SUPERIORITY|||||||0.97||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Physical Well-Being||||0.97
71724801|NCT00365105|142965184|SUPERIORITY|||||||0.57||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Social/Family Well-Being||||0.57
71770155|NCT02233946|143039998|SUPERIORITY||Risk Ratio (RR)|0.58|||||TWO_SIDED|95.0|0.37|0.91||||||"Participants with riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||0.91|0.37|
71770156|NCT02233946|143039998|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.43|1.23||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 6 months follow-up, cSBI vs. TAU."||1.23|0.43|
71724802|NCT00365105|142965184|SUPERIORITY|||||||0.7||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Emotional Well-Being||||0.70
71724803|NCT00365105|142965184|SUPERIORITY|||||||0.46||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Functional Well-Being||||0.46
71724804|NCT00365105|142965185|SUPERIORITY|||||||0.99||||||2-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
71724805|NCT00365105|142965186|SUPERIORITY|||||||0.43||||||Significance level of 0.05|t-test, 2 sided|||Index Score||||0.43
71724806|NCT00365105|142965186|SUPERIORITY|||||||0.15||||||Significance level of 0.05|t-test, 2 sided|||VAS Score||||0.15
71724807|NCT00608023|142965187|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71724808|NCT00608023|142965188|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71724809|NCT00608023|142965189|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71724810|NCT00608023|142965190|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71724811|NCT00608023|142965191|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||ANCOVA|||||||>0.05
71724812|NCT04478071|142965215|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.084|0.009|||||"Risk difference of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Primary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a lower probability, at treatment day 14, of death (8) or hospitalization, on invasive mechanical ventilation or ECMO (7) or hospitalization, on non-invasive ventilation or high flow oxygen devices (6) on the NIAID-OS. See Statistical Analysis Plan for more details.||0.009|-0.084|
71770157|NCT02233946|143039998|SUPERIORITY||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.67|2.66||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 9 months follow-up, cSBI vs. TAU."||2.66|0.67|
71830338|NCT00773370|143165624|SUPERIORITY_OR_OTHER||Slope|0.296|STANDARD_DEVIATION|9.77||0.98|TWO_SIDED||||||ANOVA|||Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.||||.98
71724813|NCT04478071|142965215|SUPERIORITY||Posterior Probability|0.94|||||TWO_SIDED||||||||Posterior probability of the risk difference of Vadadustat relative to Placebo.|||||
71724814|NCT04478071|142965216|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||"Risk ratio of Vadadustat relative to Placebo. Values under confidence interval reflect Bayesian 95% credible interval rather than frequentist confidence interval."|Trial used Bayesian analysis for superiority. Hypothesis Testing for Secondary Outcome: Among adult hospital admissions with lab-confirmed diagnosis of COVID-19, vadadustat 900 mg will demonstrate superiority to placebo as defined by a higher probability, at treatment day 14, of recovery on the MSOFA scale (MSOFA = 0).||1.1|0.92|
71724815|NCT04478071|142965216|SUPERIORITY||Posterior probability|0.57|||||TWO_SIDED||||||||Posterior probability of the risk ratio of Vadadustat relative to Placebo.|||||
71724816|NCT06053541|142965228|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.24
71724817|NCT06053541|142965229|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.37
71770158|NCT02233946|143039998|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.5|1.99||||||"Participants with no riding risk at baseline:~Adjusted Relative Risk Ratio (ARRR) of past-3-month riding risk at 12 months follow-up, cSBI vs. TAU."||1.99|0.50|
71770159|NCT02054481|143040000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.4|||<|0.0001|TWO_SIDED|95.0|19.0|53.8|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||53.8|19.0|<0.0001
71830339|NCT00773370|143165624|SUPERIORITY_OR_OTHER||Slope|15.49|STANDARD_DEVIATION|6.19||0.02|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.02
71724818|NCT06053541|142965230|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.03
71724819|NCT06053541|142965231|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Beds in the general practice and Pulmonology: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.11
71724820|NCT06053541|142965231|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Beds in Adults ICU: For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||<0.01
71724821|NCT06053541|142965232|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.01
71724822|NCT06053541|142965233|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For the evaluation of statistical significance, considering that the data do not follow a normal distribution and that the two samples are independent and not paired, the Mann-Whitney test was applied and a p value \< 0.05 was considered.||||0.07
71724823|NCT00245050|142965234|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||<|0.05|TWO_SIDED|95.0|0.536|2.16|||Chi-squared|||Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.||2.16|0.536|<0.05
71770160|NCT02054481|143040001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.6||||0.0355|TWO_SIDED|95.0|1.0|28.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 12||28.2|1.0|0.0355
71724824|NCT00245050|142965235|SUPERIORITY_OR_OTHER|||||||0.916||95.0|||||t-test, 2 sided|||||||0.916
71724825|NCT00425698|142965236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: Erythopoietin significantly improves kidney graft function. Power calculation: with a difference of at least 4 mL/min in mean eGFR between groups the number of patients enrolled per group (at least 41) would allowed the detection of a significant difference between groups at a 5% level (p\<0.05)||||<0.05
71724826|NCT02516098|142965265|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference product (for Stage 1) was assessed on the basis of the point estimate of the geometric mean ratio for Cmax in relation to the bioequivalence range of 80.00% to 125.00%.|Geometric mean ratio (%): T/REF|87.52|||||TWO_SIDED|92.46|77.18|99.24|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||99.24|77.18|
71724827|NCT02516098|142965266|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the test and reference products for Stage 1 was assessed on the basis of the 92.46% confidence intervals for the geometric mean (test/reference) ratio for the AUC0-t in relation to the bioequivalence range of 80.00% to 125.00%, with a one-sided alpha of 0.0377.|Geometric mean ratio (%): T/REF|91.74|||||TWO_SIDED|92.46|83.51|100.78|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).||100.78|83.51|
71724828|NCT02516098|142965267|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|91.66|||||TWO_SIDED|92.46|83.59|100.51|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||100.51|83.59|
71724829|NCT02516098|142965268|SUPERIORITY_OR_OTHER||Geometric mean ratio (%): T/REF|92.96|||||TWO_SIDED|92.46|81.94|105.47|||||ANOVA model was used with 'sequence', 'treatment' and 'period' as fixed effects and 'subject within sequence' as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.||105.47|81.94|
71770161|NCT02054481|143040001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1||||0.0062|TWO_SIDED|95.0|6.0|36.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 24||36.2|6.0|0.0062
71770162|NCT02054481|143040002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.1||||0.0008|TWO_SIDED|95.0|11.3|42.9|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||42.9|11.3|0.0008
71770163|NCT02054481|143040003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.1||||0.0706|TWO_SIDED|95.0|-0.8|21.1|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||21.1|-0.8|0.0706
71830340|NCT00773370|143165624|SUPERIORITY_OR_OTHER||Slope|15.193|STANDARD_DEVIATION|7.553||0.051|TWO_SIDED|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||||||.051
71657745|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71888072|NCT01890421|143296984|SUPERIORITY||Sensitivity Difference]|7.4||||0.0455|ONE_SIDED|95.0|0.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||0.5|0.0455
71724830|NCT01973387|142965269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.178|||<|0.0001|TWO_SIDED|95.0|0.109|0.291|||Log Rank|||||0.291|0.109|<0.0001
71724831|NCT03831191|142965275|SUPERIORITY||Odds Ratio (OR)|0.55||||0.638|TWO_SIDED|95.0|0.04|6.81|||Regression, Logistic|||||6.81|0.04|0.638
71724832|NCT03831191|142965275|SUPERIORITY||Odds Ratio (OR)|0.69||||0.773|TWO_SIDED|95.0|0.05|8.76|||Regression, Logistic|||||8.76|0.05|0.773
71724833|NCT03831191|142965275|SUPERIORITY||Odds Ratio (OR)|0.58||||0.671|TWO_SIDED|95.0|0.05|7.26|||Regression, Logistic|||||7.26|0.05|0.671
71724834|NCT03831191|142965276|SUPERIORITY||Risk Difference (RD)|-4.0|||>|0.999|TWO_SIDED|95.0|-27.2|19.9|||Fisher Exact|||||19.9|-27.2|>0.999
71724835|NCT03831191|142965276|SUPERIORITY||Risk Difference (RD)|4.5|||>|0.999|TWO_SIDED|95.0|-20.7|30.8|||Fisher Exact|||||30.8|-20.7|>0.999
71770164|NCT02054481|143040004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.8||||0.03|TWO_SIDED|95.0|1.9|37.7|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||37.7|1.9|0.0300
71770165|NCT02054481|143040006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2||||0.0072|TWO_SIDED|95.0|5.7|36.6|||Cochran-Mantel-Haenszel|Adjusted for weight (=\<100kg vs \>100kg) \& prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|||36.6|5.7|0.0072
71770166|NCT02054481|143040007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1844|||<|0.0001|TWO_SIDED|95.0|0.1|0.4|||Log Rank|||||0.4|0.1|<0.0001
71770167|NCT02320903|143040019|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was 0.16.|||
71770168|NCT02320903|143040019|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.22.|||
71830341|NCT02755805|143165655|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.11||||0.007|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|"F(3,74)=4.37~P-values were calculated using mixed model analyses and controlled for stoke severity as a covariate."|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.007
71724836|NCT03831191|142965276|SUPERIORITY||Risk Difference (RD)|-19.0||||0.107|TWO_SIDED|95.0|-40.0|0.2|||Fisher Exact|||||0.2|-40.0|0.107
71724837|NCT03831191|142965277|SUPERIORITY||Risk Difference (RD)|0.2|||>|0.999|TWO_SIDED|95.0|-18.1|19.3|||Fisher Exact|||||19.3|-18.1|>0.999
71724838|NCT03831191|142965277|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|14.1|||Fisher Exact|||||14.1|-22.7|>0.999
71724839|NCT03831191|142965277|SUPERIORITY||Risk Difference (RD)|-4.8|||>|0.999|TWO_SIDED|95.0|-22.7|11.2|||Fisher Exact|||||11.2|-22.7|>0.999
71657746|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71724840|NCT03831191|142965278|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71724841|NCT03831191|142965278|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71724842|NCT03831191|142965278|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71724843|NCT03831191|142965279|SUPERIORITY||Median Difference (Net)|6.55||||0.31|TWO_SIDED|95.0|-6.36|19.45|||Mixed Models Analysis|||||19.45|-6.36|0.310
71724844|NCT03831191|142965279|SUPERIORITY||Mean Difference (Net)|5.56||||0.393|TWO_SIDED|95.0|-7.5|18.63|||Mixed Models Analysis|||||18.63|-7.50|0.393
71724845|NCT03831191|142965279|SUPERIORITY||Mean Difference (Net)|3.59||||0.564|TWO_SIDED|95.0|-8.91|16.08|||Mixed Models Analysis|||||16.08|-8.91|0.564
71724846|NCT03831191|142965280|SUPERIORITY||Mean Difference (Net)|7.61||||0.356|TWO_SIDED|95.0|-8.82|24.05|||Mixed Models Analysis|||||24.05|-8.82|0.356
71724847|NCT03831191|142965280|SUPERIORITY||Mean Difference (Net)|2.33||||0.783|TWO_SIDED|95.0|-14.64|19.3|||Mixed Models Analysis|||||19.30|-14.64|0.783
71724848|NCT03831191|142965280|SUPERIORITY||Mean Difference (Net)|6.52||||0.414|TWO_SIDED|95.0|-9.4|22.43|||Mixed Models Analysis|||||22.43|-9.40|0.414
71770169|NCT02320903|143040020|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
71770170|NCT02320903|143040020|OTHER|What was the within-group change over time effect size?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for teen report on this measure was d = 0.22.|||
71770171|NCT02320903|143040021|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.10.|||
71770172|NCT02320903|143040021|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired samples T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.28.|||
71770173|NCT02320903|143040022|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.16.|||
71770174|NCT02320903|143040022|EQUIVALENCE|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report was d = 0.21.|||
71724849|NCT01562314|142965283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.821||||0.7532|TWO_SIDED|90.0|0.292|2.309|||Regression, Logistic|||||2.309|0.292|0.7532
71724850|NCT01562314|142965284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.7032|TWO_SIDED|90.0|0.419|4.04|||Regression, Logistic|||||4.040|0.419|0.7032
71724851|NCT02512874|142965308|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71724852|NCT02357472|142965326|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample Size to Achieve 0.80 Power to Test Equivalency at the α = 0.05 Significance Level for True Proportions|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|0.6216|2.002|||t-test, 2 sided|||It was caculated that 60 paticipants randomized in a 1:1between 2 arms would would have at least 85% power to detect a difference of 1.32 oocytes between the high dose group and standard dose group after 12 weeks.Sample size was determined using 2 sided 2 sample t-test (α = 0.05).Assumptions included a common standard deviation of 1.72.||2.002|0.6216|0.0003
71724853|NCT01191736|142965340|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Null hypothesis: the medians for all seven arms are equal.||Kruskal-Wallis test for multiple comparisons||||.05
71724854|NCT01191736|142965341|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|Null hypothesis: the proportions within the seven arms are equal.||Comparison of proportions of subjects who assessed responsiveness||||.05
71724855|NCT03703817|142965342|SUPERIORITY|Effectiveness: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.3648|||||||Linear mixed model|||||||0.3648
71724856|NCT03703817|142965342|SUPERIORITY|Side effect: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1395|||||||Conditional logistic regression|||||||0.1395
71724857|NCT03703817|142965342|SUPERIORITY|Convenience: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.0349|||||||Linear mixed model|||||||0.0349
71724858|NCT03703817|142965342|SUPERIORITY|Global satisfaction: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1546|||||||Linear mixed model|||||||0.1546
71724859|NCT03703817|142965343|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.1602|||||||Conditional logistic regression model|||||||0.1602
71724860|NCT03703817|142965344|SUPERIORITY|Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics).||||||0.9921|||||||Linear mixed model|||||||0.9921
71724861|NCT00349921|142965345|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of \>30% reduction in visual analog scale pain 120 min after intrathecal injection||||>0.05
71724862|NCT00778258|142965352|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.77||||0.58|TWO_SIDED|95.0|0.31|1.93|||Regression, Logistic|||||1.93|0.31|0.58
71724863|NCT00778258|142965353|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.13||||0.78|TWO_SIDED|95.0|0.48|2.68|||Chi-squared|||Progression comparison at 12 Months||2.68|0.48|0.78
71770175|NCT02320903|143040023|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?|||||||||||||Paired samples T test (change over time)|||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.62.|||
71724864|NCT00778258|142965353|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.81||||0.62|TWO_SIDED|95.0|0.34|1.91|||Chi-squared|||Progression comparison at 24 Months||1.91|0.34|0.62
71724865|NCT00778258|142965354|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||Comparison at 12 Months||||0.14
71724866|NCT00778258|142965354|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Chi-squared|||Comparison at 24 Months||||0.17
71724867|NCT00778258|142965354|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Chi-squared|||Comparison at 36 Months||||0.33
71724868|NCT00778258|142965355|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||||||0.41
71724869|NCT00778258|142965356|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Kruskal-Wallis|||||||0.09
71724870|NCT00778258|142965356|SUPERIORITY_OR_OTHER|||||||0.01||||||Null hypothesis is that correlation = 0|Spearman's Correlation|||||||0.01
71724871|NCT00778258|142965357|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Betalactoglobulin||||<0.01
71770176|NCT02320903|143040023|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.23.|||
71657747|NCT02504671|142831745|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71724872|NCT00778258|142965357|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Betalactoglobulin IgE||||<0.01
71724873|NCT00778258|142965357|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Casein IgE||||<0.01
71724874|NCT00778258|142965357|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Casein IgE||||<0.01
71770177|NCT02320903|143040024|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.|||
71770178|NCT02320903|143040024|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired samples T tests were used to measure within-groups change over time for teens.|Cohen's d for youth report was d = 0.26.|||
71770179|NCT02320903|143040025|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d =.12.|||
71770180|NCT02320903|143040026|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.81.|||
71770181|NCT02320903|143040027|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.43.|||
71724875|NCT00778258|142965357|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||Analysis on Cow's Milk IgE||||<0.01
71724876|NCT00778258|142965357|SUPERIORITY_OR_OTHER||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Cow's Milk IgE||||<0.01
71724877|NCT00778258|142965358|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||Analysis on Max Basophil Assessment||||0.01
71770182|NCT02320903|143040028|EQUIVALENCE|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report on this measure was d = 24.|||
71770183|NCT03493815|143040052|SUPERIORITY||Risk Ratio (RR)|0.73||||0.51|TWO_SIDED|95.0|0.28|1.9|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||1.90|0.28|0.51
71770184|NCT03493815|143040053|SUPERIORITY||Risk Ratio (RR)|0.58||||0.41|TWO_SIDED|95.0|0.15|2.18|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.|||2.18|0.15|0.41
71770185|NCT03493815|143040054|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71770186|NCT03493815|143040055|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
71770187|NCT00178503|143040068|SUPERIORITY_OR_OTHER||Linear trend P value|0.0|||=|0.001|||||||ANOVA|||Data were analyzed using SPSS-PC repeated measures one-way analysis of variance (ANOVA), with MPH dosing regimen as the within-subjects variable.||||=.001
71770188|NCT00178503|143040069|SUPERIORITY_OR_OTHER||Linear p|0.005||||0.005|||||||ANOVA|||||||.005
71770189|NCT00178503|143040070|SUPERIORITY_OR_OTHER||Linear p|0.0|||<|0.001||0.0|||||ANOVA|||||||<.001
71770190|NCT02093351|143040073|EQUIVALENCE|If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.06|1.22|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.22|1.06|
71770191|NCT02093351|143040074|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.8|||||TWO_SIDED|90.0|0.71|0.9|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.90|0.71|
71888073|NCT01890421|143296984|SUPERIORITY||Sensitivity Difference]|34.3|||<|0.0001|ONE_SIDED|95.0|25.2||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||25.2|<0.0001
71724878|NCT00778258|142965358|SUPERIORITY_OR_OTHER|||||||0.22||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Max Basophil Assessment||||0.22
71724879|NCT00778258|142965358|SUPERIORITY_OR_OTHER|||||||0.59|||||||Kruskal-Wallis|||Analysis on Tregs||||0.59
71724880|NCT00778258|142965358|SUPERIORITY_OR_OTHER|||||||0.32||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Tregs||||0.32
71724881|NCT00778258|142965359|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Kruskal-Wallis|||||||0.50
71724882|NCT00778258|142965360|SUPERIORITY_OR_OTHER|||||||0.033||||||Correlation = -0.18|Spearman Correlation|||Baseline Comparison||||0.033
71724883|NCT00778258|142965360|SUPERIORITY_OR_OTHER|||||||0.002||||||Correlation = -0.34|Spearman Correlation|||Month 12 Comparison||||0.002
71724884|NCT00778258|142965360|SUPERIORITY_OR_OTHER|||||||0.156||||||Correlation = -0.20|Spearman Correlation|||Month 24 Comparison||||0.156
71724885|NCT00778258|142965360|SUPERIORITY_OR_OTHER|||||||0.077||||||Correlation = -0.27|Spearman Correlation|||Month 36 Comparison||||0.077
71770192|NCT02093351|143040075|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|Geometric Least Squares (GLS) Mean Ratio|0.9|||||TWO_SIDED|90.0|0.84|0.97|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.97|0.84|
71770193|NCT02093351|143040076|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.84|1.04|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.04|0.84|
71770194|NCT02093351|143040077|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.98|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.98|0.91|
71770195|NCT02093351|143040078|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.09|||||TWO_SIDED|90.0|0.99|1.21|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters||1.21|0.99|
71770196|NCT02093351|143040079|EQUIVALENCE|If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.16|||||TWO_SIDED|90.0|1.11|1.21|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.||1.21|1.11|
71770197|NCT02093351|143040080|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.73|||||TWO_SIDED|90.0|0.63|0.84|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.||0.84|0.63|
71770198|NCT02093351|143040081|EQUIVALENCE|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|GLS Mean Ratio|0.86|||||TWO_SIDED|90.0|0.8|0.93|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.||0.93|0.80|
71770199|NCT02093351|143040082|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.76|1.05|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.||1.05|0.76|
71770200|NCT02093351|143040083|EQUIVALENCE|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.95|||||TWO_SIDED|90.0|0.91|0.99|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.||0.99|0.91|
71724886|NCT00778258|142965361|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||36 Month Comparison||||<0.01
71770201|NCT02093351|143040084|EQUIVALENCE|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.15|||||TWO_SIDED|90.0|1.07|1.25|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters.||1.25|1.07|
71724887|NCT01926041|142965368|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.48|0.84||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||0.84|0.48|0.008
71724888|NCT01926041|142965369|SUPERIORITY||Cox Proportional Hazard|1.85||||0.023|TWO_SIDED|95.0|1.13|3.04||Statistical significance levels were determined by two-tailed tests (P \< 0.05).|Regression, Cox|||||3.04|1.13|0.023
71724889|NCT01926041|142965375|OTHER||Beta Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71724890|NCT03111550|142965380|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)||||||0.02041|ONE_SIDED||||||Exact test on binomial distribution|||||||0.02041
71724891|NCT03111550|142965381|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)||||||0.1969|ONE_SIDED|||||For ZQR00 retinal detachment|Exact test on binomial distribution|||||||0.1969
71724892|NCT03111550|142965381|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4655|ONE_SIDED|||||For ZHR00 secondary surgical intervention|Exact test of binomial distribution|||||||0.4655
71724893|NCT03111550|142965381|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.021|ONE_SIDED|||||For ZQR00 secondary surgical intention|Exact test on binomial distribution|||||||0.0210
71724894|NCT03111550|142965381|SUPERIORITY|Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)||||||0.4698|ONE_SIDED|||||For ZXR00 secondary surgical intervention|Exact test on binomial distribution|||||||0.4698
71724895|NCT01331837|142965406|NON_INFERIORITY_OR_EQUIVALENCE|In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI \<1.8 was required.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.77|1.43||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.43|0.77|
71770202|NCT01099709|143040085|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||108.51|101.06|
71770203|NCT01099709|143040085|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|105.0|||||TWO_SIDED|90.0|101.06|108.51|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||108.51|101.06|
71830342|NCT02755805|143165656|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.76||||0.09|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=2.55|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||0.09
71830343|NCT02755805|143165657|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|1.23||||0.002|TWO_SIDED|||||a priori threshold set at p\<0.05|Mixed Models Analysis|F(2,34)=7.83|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.||||.002
71724896|NCT01331837|142965408|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62||||||"The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.62|0.76|
71724897|NCT01331837|142965410|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.73|1.4||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.40|0.73|
71724898|NCT01331837|142965412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.7|1.56||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.56|0.70|
71830344|NCT02755805|143165658|SUPERIORITY_OR_OTHER||Cohen's d effect size at month 6|0.7||||0.04|TWO_SIDED|||||a priori threshold set at \<0.05|repeated measures fixed effects model|F(2,28)=3.61|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||||.04
71724899|NCT01331837|142965414|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.34|0.73|
71724900|NCT01331837|142965416|NON_INFERIORITY_OR_EQUIVALENCE|'The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.49||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.49|0.54|
71724901|NCT01331837|142965418|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.64|1.63||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.63|0.64|
71830345|NCT02252042|143165672|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0316|TWO_SIDED|95.0|0.67|1.01|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.01|0.67|0.03160
71830346|NCT02252042|143165673|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01605|TWO_SIDED|95.0|0.65|0.98||Nominal p-value|Log Rank||Nominal HR. Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.98|0.65|0.01605
71830347|NCT02252042|143165674|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00493|TWO_SIDED|95.0|0.58|0.93|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||0.93|0.58|0.00493
71830348|NCT02252042|143165675|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.32504|TWO_SIDED|95.0|0.79|1.16|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.16|0.79|0.32504
71888074|NCT01890421|143296984|SUPERIORITY||Sensitivity Difference|30.6|||<|0.0001|ONE_SIDED|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||21.7|<0.0001
71724902|NCT01331837|142965420|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.53|||||TWO_SIDED|95.0|0.8|2.92||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||2.92|0.80|
71724903|NCT01331837|142965422|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.7|1.41||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~* Previous exposure to anti-TNF (Yes/No)~* History of CV events (Yes/No)"||1.41|0.70|
71724904|NCT01380535|142965427|OTHER|||||||0.373|||||||Fisher Exact|||||||0.373
71724905|NCT00218634|142965443|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||HLM|||We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.||||<.05
71724906|NCT00218634|142965444|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.|GLM and HLM|||||||<.05
71724907|NCT00218634|142965446|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CD4 would be more improved in the treatment condition|HLM|||follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.||||<.05
71724908|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.136||0.499|TWO_SIDED|95.0|-0.36|0.18|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||0.18|-0.36|0.4990
71724909|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.135|<|0.0001|TWO_SIDED|95.0|-0.83|-0.29|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||-0.29|-0.83|<0.0001
71830349|NCT02252042|143165676|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07736|TWO_SIDED|95.0|0.69|1.06|||Log Rank||Cox regression model with treatment as a single covariate|||1.06|0.69|0.07736
71830350|NCT02252042|143165677|SUPERIORITY||Difference in percentages|4.6||||0.061|TWO_SIDED|95.0|-1.2|10.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||10.6|-1.2|0.0610
71830351|NCT02252042|143165678|SUPERIORITY||Difference in percentages|7.5||||0.0171|TWO_SIDED|95.0|0.6|14.6|||Log Rank|H0: difference in %=0; H1: difference in %\>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||14.6|0.6|0.0171
71724910|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|-1.1|-0.56|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference is calculated as Test value minus Negative Control value.|Change from Baseline at Day 3||-0.56|-1.10|<0.0001
71724911|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.112||0.009|TWO_SIDED|95.0|-0.52|-0.08|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||-0.08|-0.52|0.0090
71724912|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-0.89|-0.45|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||-0.45|-0.89|<0.0001
71724913|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-1.66|-1.22|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 14||-1.22|-1.66|<0.0001
71724914|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.116||0.0007|TWO_SIDED|95.0|-0.63|-0.17|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||-0.17|-0.63|0.0007
71770204|NCT01099709|143040086|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.6|||||TWO_SIDED|90.0|93.73|97.53|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.53|93.73|
71770205|NCT01099709|143040087|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric test/Ref Ratio x 100|95.7|||||TWO_SIDED|90.0|93.85|97.68|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.68|93.85|
71770206|NCT00039871|143040092|SUPERIORITY_OR_OTHER||Binomial Approximation|0.217||||||99.0|0.195|0.239||||||||0.239|0.195|
71770207|NCT00039871|143040093|SUPERIORITY_OR_OTHER||Binomial Approximation|0.563||||||95.0|0.529|0.596||||||||0.596|0.529|
71770208|NCT00039871|143040094|SUPERIORITY_OR_OTHER||Binomial Approximation|0.122||||||95.0|0.076|0.169||||||||0.169|0.076|
71770209|NCT01545843|143040115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Mixed Models Analysis|||||||.202
71770210|NCT04243421|143040123|OTHER||Median Difference (Final Values)|6.0||||0.0007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0007
71770211|NCT04243421|143040124|OTHER||Median Difference (Final Values)|1.25||||0.0005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71770212|NCT04243421|143040124|OTHER||Median Difference (Final Values)|1.0||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0034
71770213|NCT04243421|143040125|OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71770214|NCT01249118|143040127|SUPERIORITY_OR_OTHER||Ratio of LS Means|8.45|||||TWO_SIDED|90.0|7.08|10.08|||||The 90 percent (%) confidence intervals (CI) of test group (oral dose) means relative to reference group (IV dose) means were obtained by taking antilog of corresponding 90% CI for the differences between the means on the log scale.|Least squares (LS) mean was calculated from analysis of variance (ANOVA). Data for dose-normalized Cmax were natural log-transformed prior to analysis.||10.08|7.08|
71770215|NCT01249118|143040131|SUPERIORITY_OR_OTHER||Ratio of LS Means|48.6|||||TWO_SIDED|90.0|41.43|56.94|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS means was calculated from ANOVA. Data for dose-normalized AUC (0 - t) were natural log-transformed prior to analysis.||56.94|41.43|
71770216|NCT01249118|143040133|SUPERIORITY_OR_OTHER||Ratio of LS Means|45.9|||||TWO_SIDED|90.0|39.74|53.06|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS mean was calculated from ANOVA. Data for dose-normalized AUC (0 - ∞) were natural log-transformed prior to analysis.||53.06|39.74|
71724915|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.116|<|0.0001|TWO_SIDED|95.0|-0.85|-0.39|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||-0.39|-0.85|<0.0001
71724916|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.85|-1.38|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 28||-1.38|-1.85|<0.0001
71770217|NCT00095238|143040160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.3|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||Comparison of 2 treatment arms at Month 6 (first 2 columns)||1.3|-0.8|
71770218|NCT00095238|143040160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|baseline score used as covariate; treatment, visit, treatment-by-visit, \& baseline angiotensin-converting enzyme (ACE) inhibitors used as predictors||comparison of 2 treatment arms at Month 14 (columns 3 and 4)||1.7|-0.5|
71770219|NCT00075270|143040203|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.87||||0.142|TWO_SIDED|95.0|0.72|1.05||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio is based on the log-rank test.|||1.05|0.72|0.142
71770220|NCT00075270|143040204|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.82||||0.094|TWO_SIDED|95.0|0.65|1.04||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio was based on the log-rank test.|||1.04|0.65|0.094
71724917|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.112||0.0015|TWO_SIDED|95.0|-0.59|-0.14|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||-0.14|-0.59|0.0015
71724918|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.05|-0.61|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||-0.61|-1.05|<0.0001
71724919|NCT05243745|142965466|SUPERIORITY||Adjusted Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.95|-1.49|||ANCOVA|Analysis was performed using ANCOVA model with study product as a factor and baseline Schiff sensitivity score as a covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 56||-1.49|-1.95|<0.0001
71724920|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|5.93|STANDARD_ERROR_OF_MEAN|2.572||0.0231|TWO_SIDED|95.0|0.83|11.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 3||11.02|0.83|0.0231
71724921|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|18.42|STANDARD_ERROR_OF_MEAN|2.549|<|0.0001|TWO_SIDED|95.0|13.37|23.47|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 3||23.47|13.37|<0.0001
71724922|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|23.93|STANDARD_ERROR_OF_MEAN|2.571|<|0.0001|TWO_SIDED|95.0|18.83|29.02|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 3||29.02|18.83|<0.0001
71724923|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|8.97|STANDARD_ERROR_OF_MEAN|2.293||0.0002|TWO_SIDED|95.0|4.43|13.51|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 14||13.51|4.43|0.0002
71724924|NCT05243745|142965467|SUPERIORITY||Slope|17.71|STANDARD_ERROR_OF_MEAN|2.265|<|0.0001|TWO_SIDED|95.0|13.22|22.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 14||22.20|13.22|<0.0001
71724925|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|32.81|STANDARD_ERROR_OF_MEAN|2.288|<|0.0001|TWO_SIDED|95.0|28.27|37.34|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 14||37.34|28.27|<0.0001
71724926|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|10.2|STANDARD_ERROR_OF_MEAN|2.485|<|0.0001|TWO_SIDED|95.0|5.28|15.13|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 28||15.13|5.28|<0.0001
71724927|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|13.92|STANDARD_ERROR_OF_MEAN|2.46|<|0.0001|TWO_SIDED|95.0|9.05|18.8|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 28||18.80|9.05|<0.0001
71724928|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|36.51|STANDARD_ERROR_OF_MEAN|2.568|<|0.0001|TWO_SIDED|95.0|31.42|41.6|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control.|Change from Baseline at Day 28||41.60|31.42|<0.0001
71724929|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|9.73|STANDARD_ERROR_OF_MEAN|2.761||0.0006|TWO_SIDED|95.0|4.26|15.2|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 1 value.|Change from Baseline at Day 56||15.20|4.26|0.0006
71724930|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|19.06|STANDARD_ERROR_OF_MEAN|2.772|<|0.0001|TWO_SIDED|95.0|13.57|24.55|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Comparator 2 value.|Change from Baseline at Day 56||24.55|13.57|<0.0001
71724931|NCT05243745|142965467|SUPERIORITY||Adjusted Mean Difference|39.33|STANDARD_ERROR_OF_MEAN|2.829|<|0.0001|TWO_SIDED|95.0|33.73|44.94|||ANCOVA|Analysis was performed using ANCOVA model with study product, baseline Schiff stratification as a factor and baseline tactile threshold as covariate.|Adjusted Mean Difference was calculated as Test value minus Negative Control value.|Change from Baseline at Day 56||44.94|33.73|<0.0001
71724932|NCT01159171|142965516|SUPERIORITY_OR_OTHER|||||||0.0047||0.0||||One-sided p-value|One sample exact binomial test|||||||0.0047
71770221|NCT00708201|143040248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.773|||<|0.0001|TWO_SIDED|95.0|1.359|2.311|||Wald's Chi-Square|||||2.311|1.359|<0.0001
71888075|NCT01890421|143296989|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.5|35.8|||McNemar 2-sided test,alpha level of 5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||35.8|18.5|<0.0001
71888076|NCT01890421|143296989|SUPERIORITY||Sensitivity Difference|27.9|||<|0.0001|TWO_SIDED|95.0|19.9|34.4|||McNemar 2-sided test,alpha level of 10%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images - secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least \>=50% by QCA.||34.4|19.9|<0.0001
71724933|NCT01461928|142965528|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.41|TWO_SIDED|95.0|0.37|1.53||Power at time of final analysis was less than 40%. Final analysis was not able to address its primary objective.|Stratified Long-rank|||The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma). Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.||1.53|0.37|= 0.410
71724934|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.4261|||||||t-test, 1 sided|||||||0.4261
71724935|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.4219|||||||t-test, 1 sided|||||||0.4219
71724936|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.1826|||||||t-test, 1 sided|||||||0.1826
71724937|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0090
71724938|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.3421|||||||t-test, 1 sided|||||||0.3421
71724939|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0100
71724940|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.2103|||||||t-test, 1 sided|||||||0.2103
71724941|NCT01018134|142965549|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 1 sided|||||||0.1200
71724942|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.2631|||||||t-test, 1 sided|||||||0.2631
71724943|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.2968|||||||t-test, 1 sided|||||||0.2968
71657748|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71724944|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.0186||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0186
71724945|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.0361||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0361
71724946|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.007||||||statistically significant difference between treatment groups|t-test, 1 sided|||||||0.0070
71724947|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.1583|||||||t-test, 1 sided|||||||0.1583
71724948|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.2078|||||||t-test, 1 sided|||||||0.2078
71724949|NCT01018134|142965550|SUPERIORITY_OR_OTHER|||||||0.2878|||||||t-test, 1 sided|||||||0.2878
71724950|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.2713|||||||Wilcoxon (Mann-Whitney)|||||||0.2713
71724951|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.2689|||||||Wilcoxon (Mann-Whitney)|||||||0.2689
71724952|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.0419|||||||Wilcoxon (Mann-Whitney)|||||||0.0419
71724953|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.0309|||||||Wilcoxon (Mann-Whitney)|||||||0.0309
71724954|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.1126|||||||Wilcoxon (Mann-Whitney)|||||||0.1126
71724955|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Wilcoxon (Mann-Whitney)|||||||0.0033
71724956|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.4967|||||||Wilcoxon (Mann-Whitney)|||||||0.4967
71724957|NCT01018134|142965551|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Wilcoxon (Mann-Whitney)|||||||0.0749
71724958|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.2442|||||||Wilcoxon (Mann-Whitney)|||||||0.2442
71724959|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Wilcoxon (Mann-Whitney)|||||||0.2664
71724960|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.1328|||||||Wilcoxon (Mann-Whitney)|||||||0.1328
71724961|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||||||0.0528
71724962|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||||||0.0297
71724963|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Wilcoxon (Mann-Whitney)|||||||0.0093
71724964|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.2230
71724965|NCT01018134|142965552|SUPERIORITY_OR_OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
71724966|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.2397|||||||Wilcoxon (Mann-Whitney)|||||||0.2397
71724967|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Wilcoxon (Mann-Whitney)|||||||0.3794
71724968|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.0383|||||||Wilcoxon (Mann-Whitney)|||||||0.0383
71724969|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.0154|||||||Wilcoxon (Mann-Whitney)|||||||0.0154
71724970|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.1892|||||||Wilcoxon (Mann-Whitney)|||||||0.1892
71724971|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
71724972|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.0363|||||||Wilcoxon (Mann-Whitney)|||||||0.0363
71724973|NCT01018134|142965553|SUPERIORITY_OR_OTHER|||||||0.2162|||||||Wilcoxon (Mann-Whitney)|||||||0.2162
71738996|NCT00620113|142990736|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.52|||<|0.001|TWO_SIDED|95.0|-25.11|-5.93||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-5.93|-25.11|<0.001
71770222|NCT00708201|143040249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|||<|0.001|TWO_SIDED|95.0|-37.8|-11.5|||Log Rank|||||-11.5|-37.8|<0.001
71888077|NCT01446419|143297013|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.||||||0.019
71724974|NCT02222909|142965558|OTHER|The significance of the difference-in-differences statistic was assessed using randomization inference, a non-parametric permutation test. Confidence intervals were determined by inversion of the test statistic.|Difference in differences|0.0182||||0.63|TWO_SIDED|95.0|-0.12|0.11||We calculated the proportion of permuted statistics with values higher in magnitude than that of the observed adjusted difference in differences (the p-value). We inverted the test statistic to determine confidence intervals.|Randomization inference||The estimation parameter is the difference between the average adjusted change in the monthly ED visits and hospital days from the pre- to post- intervention periods for the patients assigned to the iCBOs as compared to the cCBOs.|The difference between the average sum of the number of days spent in the hospital and ED visits in the past month, pre- and post-intervention, adjusted for pre- intervention variables, was calculated for each patients. The average change scores among patients assigned to each CBO defined the CBO-level outcomes. We calculated a weighted average of the CBO outcomes separately for the iCBOs and cCBOs, defining the difference-in-differences statistic as the difference between the two averages.||0.11|-0.12|0.63
71724975|NCT01981863|142965561|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71724976|NCT02242435|142965562|SUPERIORITY|||||||0.26||||||Adjusted for baseline WOMAC score.|ANCOVA|||||||0.26
71724977|NCT02242435|142965563|SUPERIORITY|||||||0.3||||||Adjustment for baseline WOMAC score.|ANCOVA|||||||0.30
71770223|NCT00708201|143040250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|||<|0.001|TWO_SIDED|95.0|-35.0|-9.9|||Log Rank|||||-9.9|-35.0|<0.001
71770224|NCT00708201|143040251|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71770225|NCT00708201|143040252|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||<|0.01|TWO_SIDED|95.0|1.12|1.71|||Fisher Exact||This is the relative risk for being a responder (alvimopan/placebo).|||1.71|1.12|<0.01
71830352|NCT02252042|143165681|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.14545|TWO_SIDED|95.0|0.7|1.12||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.12|0.70|0.14545
71830353|NCT02252042|143165682|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.05851|TWO_SIDED|95.0|0.62|1.06||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.06|0.62|0.05851
71724978|NCT00117715|142965566|OTHER|||||||0.035||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(DM/DX) over time||||0.035
71724979|NCT00117715|142965567|OTHER|||||||0.194||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(3HM/DX) over time||||0.194
71724980|NCT00117715|142965568|OTHER|||||||0.831||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log ((AAMU+1MX+1MU)/1,7,U) over time||||0.831
71830354|NCT02252042|143165683|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.65759|TWO_SIDED|95.0|0.86|1.27|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.27|0.86|0.65759
71657749|NCT02504671|142831745|OTHER||Difference|27.0|||||TWO_SIDED|95.0|11.4|42.7|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.7|11.4|
71724981|NCT01089413|142965570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8579|TWO_SIDED|95.0|0.7|1.54|||Regression, Cox|||||1.54|0.70|0.8579
71724982|NCT01089413|142965571|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1555|TWO_SIDED|95.0|0.3|1.21|||Regression, Cox|||||1.21|0.30|0.1555
71724983|NCT01971463|142965581|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank|||Change in oCBF from baseline to post-bolus, ipsilesional hemisphere||||<0.05
71724984|NCT01971463|142965581|SUPERIORITY|Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere|Slope|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.07|||Mixed Models Analysis|||||0.07|0.03|<0.001
71724985|NCT00420004|142965592|SUPERIORITY_OR_OTHER|||||||0.494|||||||Mixed Models Analysis|||||||0.494
71724986|NCT01610557|142965617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.039|TWO_SIDED|95.0|0.07|2.5|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||2.5|0.07|0.039
71770226|NCT00708201|143040253|SUPERIORITY_OR_OTHER||Percent difference|-20.71|||<|0.001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for overall POM is presented.||||<0.001
71770227|NCT00708201|143040254|SUPERIORITY_OR_OTHER||Percent difference|27.05|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
71770228|NCT00708201|143040255|SUPERIORITY_OR_OTHER||Percent difference|25.2|||<|0.0001|TWO_SIDED||||||Fisher Exact||Percent difference = alvimopan - placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.||||<0.0001
71770229|NCT00708201|143040256|SUPERIORITY_OR_OTHER||Percent difference|-6.94||||0.0946|TWO_SIDED|95.0|-14.5|0.62|||Fisher Exact||Percent difference = alvimopan - placebo.|||0.62|-14.5|0.0946
71770230|NCT03828370|143040257|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
71770231|NCT03828370|143040258|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||.034
71770232|NCT03490981|143040259|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.486|TWO_SIDED||||||ANCOVA|||||||.486
71770233|NCT03490981|143040260|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|1.16||0.342|TWO_SIDED||||||ANCOVA|||||||.342
71770234|NCT03490981|143040261|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.31||0.646|TWO_SIDED||||||ANCOVA|||||||.646
71830355|NCT02252042|143165684|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.51982|TWO_SIDED|95.0|0.81|1.26|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) \& PD-L1 status (Strongly Positive, Not Strongly Positive)|||1.26|0.81|0.51982
71724987|NCT01610557|142965618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-48.0|||<|0.001|TWO_SIDED|95.0|-65.0|-31.0|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.|||-31|-65|<0.001
71724988|NCT02039219|142965643|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.4||0.1758|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at baseline OCA arms had a mean (SD) of 14.9(2.4), Placebo arms had a mean (SD) of 16.4 (2.2).|Baseline||||0.1758
71724989|NCT02039219|142965643|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Net)|2.4|STANDARD_DEVIATION|6.8||0.3839|TWO_SIDED|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at day 42 OCA arms had a mean (SD) of 11.5 (6.8), Placebo arms had a mean (SD) of 13.9(4.6).|Day 42||||0.3839
71657750|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71724990|NCT02039219|142965651|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|ONE_SIDED||||||Log Rank|||Day 42||||.3938
71724991|NCT02039219|142965651|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
71724992|NCT02039219|142965651|SUPERIORITY|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
71724993|NCT02039219|142965651|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 42||||.3938
71724994|NCT02039219|142965651|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 90||||.3938
71724995|NCT02039219|142965651|SUPERIORITY|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|TWO_SIDED||||||Log Rank|||Day 180||||.3938
71724996|NCT02039219|142965655|SUPERIORITY|The type of statistical test is superiority.|Mean Difference (Final Values)|0.4|STANDARD_DEVIATION|2.5||0.8094|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.8094
71724997|NCT02974855|142965675|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
71724998|NCT02974855|142965675|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.05||||0.0001|TWO_SIDED|80.0|0.02|0.14|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.14|0.02|0.0001
71724999|NCT02974855|142965675|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.15||||0.0002|TWO_SIDED|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.29|0.08|0.0002
71725000|NCT02974855|142965675|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.03||||0.0005|TWO_SIDED|80.0|0.01|0.1|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.10|0.01|0.0005
71725001|NCT02974855|142965675|SUPERIORITY|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is \<1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand \>0.3.|ratio|0.09|||<|0.0001|TWO_SIDED|80.0|0.05|0.16|||Negative Binomial Model|||The comparator was the Historical on Demand Group||0.16|0.05|<0.0001
71725002|NCT02974855|142965675|SUPERIORITY||ratio|0.18|||<|0.0001|TWO_SIDED|80.0|0.11|0.31|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.31|0.11|<0.0001
71725003|NCT02974855|142965675|SUPERIORITY||ratio|0.1||||0.0002|TWO_SIDED|80.0|0.04|0.22|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.22|0.04|0.0002
71725004|NCT02974855|142965675|SUPERIORITY||ratio|0.2||||0.0154|TWO_SIDED|80.0|0.09|0.47|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.47|0.09|0.0154
71725005|NCT02974855|142965675|SUPERIORITY||ratio|0.04||||0.0005|TWO_SIDED|80.0|0.01|0.14|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.14|0.01|0.0005
71657751|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71725006|NCT02974855|142965675|SUPERIORITY||ratio|0.12|||<|0.0001|TWO_SIDED|80.0|0.08|0.2|||Negative Binomial Model|||On-Study versus Pre-Treatment||0.20|0.08|<0.0001
71725007|NCT00129701|142965692|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||||||0.064
71725008|NCT03130439|142965728|OTHER||Objective Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.247||||||||0.247|0.000|
71725009|NCT03130439|142965731|OTHER||Disease Control Rate|0.222|||||TWO_SIDED|95.0|0.086|0.423||||||||0.423|0.086|
71725010|NCT03130439|142965732|OTHER||Clinical Benefit Rate|0.148|||||TWO_SIDED|95.0|0.042|0.337||||||||0.337|0.042|
71770235|NCT03490981|143040262|SUPERIORITY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.205||0.205|TWO_SIDED||||||ANCOVA|||||||.205
71770236|NCT03490981|143040263|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|2.94||0.492|TWO_SIDED||||||ANCOVA|||||||.492
71725011|NCT00123162|142965736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.9|7.6|||ANCOVA|adjusted for baseline pain intensity (Visual Analog Scale (VAS) score).||With 26 subjects per treatment group and an assumed within-group standard deviation of 7 units, the study was designed to have 90% statistical power for a two-sided, 0.05 significance level test to detect a difference of 6.5 units in TOPAR4 between a single dose of 100 mg of sildenafil and placebo. However, we anticipated subject drop-out as high as 15%; therefore, we planned to recruit 31 subjects per treatment group.||7.6|2.9|<0.001
71725012|NCT00123162|142965737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.6|||<|0.001|TWO_SIDED|95.0|-58.3|-26.8|||Mixed Models Analysis||Comparison of the VAS score at hour 4 (Sildenafil Citrate - Placebo)|||-26.8|-58.3|<.001
71725013|NCT04838054|142965738|SUPERIORITY||Mean Difference (Net)|0.27||||0.28|TWO_SIDED|||||p-values \<0.05 means statistically significant|ANCOVA|||||||0.28
71725014|NCT04838054|142965739|SUPERIORITY||Mean Difference (Net)|0.41||||0.011|TWO_SIDED|||||p\<0.05 means statistically significant|ANCOVA|||||||0.011
71725015|NCT04838054|142965740|SUPERIORITY||Mean Difference (Net)|2.99|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71725016|NCT00729677|142965741|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||.05
71725017|NCT01126437|142965776|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.837|1.094|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.094|0.837|
71725018|NCT01126437|142965776|NON_INFERIORITY_OR_EQUIVALENCE|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.996|||||TWO_SIDED|95.0|0.872|1.136|||Regression, Cox|||H0: Hazard Ratio for Respimat/HandiHaler \>= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler \< 1.25||1.136|0.872|
71725019|NCT01126437|142965777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.978||||0.4194|TWO_SIDED|95.0|0.928|1.032|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.032|0.928|0.4194
71725020|NCT01126437|142965777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.016||||0.5593|TWO_SIDED|95.0|0.964|1.07|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.070|0.964|0.5593
71725021|NCT01126437|142965777|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.038||||0.1639|TWO_SIDED|95.0|0.985|1.094|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"||1.094|0.985|0.1639
71725022|NCT01126437|142965778|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.038|0.018||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||0.018|-.038|
71738997|NCT00620113|142990736|SUPERIORITY_OR_OTHER||Difference in LS Means|-12.55||||0.009|TWO_SIDED|95.0|-22.16|-2.94||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-2.94|-22.16|0.009
71770237|NCT03490981|143040264|SUPERIORITY||Mean Difference (Final Values)|4.31|STANDARD_ERROR_OF_MEAN|3.84||0.272|TWO_SIDED||||||ANCOVA|||||||.272
71770238|NCT03490981|143040265|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.82||0.87|TWO_SIDED||||||ANCOVA|||||||.870
71770239|NCT03490981|143040266|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.67||0.57|TWO_SIDED||||||ANCOVA|||||||.570
71770240|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0056
71770241|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0866
71770242|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0568
71725023|NCT01126437|142965778|NON_INFERIORITY_OR_EQUIVALENCE|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.037|STANDARD_ERROR_OF_MEAN|0.014|||TWO_SIDED|95.0|-0.065|-0.009||An autoregression-1 covariance structure modeled the within-subject errors because visits were equally spaced. The Kenward-Roger approximation estimated denominator degrees of freedom.|Mixed Model Repeated Measures||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler \< 50 ml"||-.009|-.065|
71725024|NCT01126437|142965779|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.833|TWO_SIDED|95.0|0.95|1.06|||Negative binomial regression|||||1.06|0.95|0.8330
71725025|NCT01126437|142965779|SUPERIORITY_OR_OTHER||Rate ratio of events|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.8047|TWO_SIDED|95.0|0.94|1.05|||Negative binomial regression|||||1.05|0.94|0.8047
71725026|NCT01126437|142965779|SUPERIORITY_OR_OTHER||Rate ratio of events|1.01|STANDARD_ERROR_OF_MEAN|0.03||0.6468|TWO_SIDED|95.0|0.96|1.07|||Negative binomial regression|||||1.07|0.96|0.6468
71725027|NCT01126437|142965780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.1762|TWO_SIDED|95.0|0.971|1.176|||Regression, Cox|||||1.176|0.971|0.1762
71725028|NCT01126437|142965780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.6384|TWO_SIDED|95.0|0.929|1.128|||Regression, Cox|||||1.128|0.929|0.6384
71830356|NCT00071799|143165690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|95.0|||||Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||"A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 9.8 and high range of 17.0 months."||||0.0001
71725029|NCT01126437|142965780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.044||||0.3784|TWO_SIDED|95.0|0.949|1.148|||Regression, Cox|||||1.148|0.949|0.3784
71725030|NCT01126437|142965781|SUPERIORITY_OR_OTHER||Rate ratio of events|1.09|STANDARD_ERROR_OF_MEAN|0.06||0.1255|TWO_SIDED|95.0|0.98|1.22||p-value from negative binomial regression.|Negative binomial regression|||||1.22|0.98|0.1255
71725031|NCT01126437|142965781|SUPERIORITY_OR_OTHER||Rate ratio of events|1.06|STANDARD_ERROR_OF_MEAN|0.06||0.3441|TWO_SIDED|95.0|0.94|1.18||p-value from negative binomial regression.|Negative binomial regression|||||1.18|0.94|0.3441
71725032|NCT01126437|142965781|SUPERIORITY_OR_OTHER||Rate ratio of events|1.03|STANDARD_ERROR_OF_MEAN|0.06||0.5573|TWO_SIDED|95.0|0.92|1.16||p-value from negative binomial regression.|Negative binomial regression|||||1.16|0.92|0.5573
71725033|NCT01126437|142965782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.6823|TWO_SIDED|95.0|0.959|1.066|||Regression, Cox|||||1.066|0.959|0.6823
71725034|NCT01126437|142965782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983||||0.5377|TWO_SIDED|95.0|0.932|1.037|||Regression, Cox|||||1.037|0.932|0.5377
71725035|NCT01126437|142965782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.028||||0.3048|TWO_SIDED|95.0|0.975|1.084|||Regression, Cox|||||1.084|0.975|0.3048
71830357|NCT00071799|143165690|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.0002|TWO_SIDED|95.0|0.43|0.77|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.77|0.43|0.0002
71657752|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71725036|NCT01126437|142965783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.105||||0.3043|TWO_SIDED|95.0|0.913|1.336|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.336|0.913|0.3043
71725037|NCT01126437|142965783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.3263|TWO_SIDED|95.0|0.909|1.331|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.331|0.909|0.3263
71725038|NCT01126437|142965783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.004||||0.9644|TWO_SIDED|95.0|0.834|1.209|||Regression, Cox|||Causes of death from MACE were determined by adjudication.||1.209|0.834|0.9644
71725039|NCT01126437|142965784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2439|TWO_SIDED|95.0|0.898|1.526|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.526|0.898|0.2439
71725040|NCT01126437|142965784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.4413|TWO_SIDED|95.0|0.85|1.453|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.453|0.850|0.4413
71725041|NCT01126437|142965784|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.054||||0.691|TWO_SIDED|95.0|0.814|1.363|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.||1.363|0.814|0.6910
71725042|NCT01220973|142965793|OTHER||Slope|0.74|||||TWO_SIDED|||||||||||||
71725043|NCT02851797|142965827|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in 4SC at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|generalised least square mean ratio|0.86|||=|0.0345|TWO_SIDED|95.0|0.745|0.989||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|ANCOVA||LS Means, CIs, and p-values are obtained from ANCOVA model on change from baseline in 4SC at Month 18 with baseline values for: the above mentioned parameters as covariates, with steroid use and treatment group as independent classificat factors.|Log transformation applied||0.989|0.745|=0.0345
71725044|NCT02851797|142965828|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in time to rise from the Floor at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 m, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|difference in least square means|-3.28|||=|0.3044|TWO_SIDED|95.0|-9.573|3.018||See comment above|ANCOVA||See comment above|||3.018|-9.573|=0.3044
71725045|NCT02851797|142965829|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in distance walked at the end of the 6-minute walking test (6MWT) at Month 18 with baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|9.96|||=|0.3723|TWO_SIDED|95.0|-12.071|31.983||See comment above|ANCOVA|LS means, CIs, p-values were obtained from analysis of covariance model on change from baseline in distance walked at the end of the 6MWT at Month18.|See comment above|||31.983|-12.071|=0.3723
71725046|NCT02851797|142965830|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in total NSAA score at Month 18 with baseline values for: total NSAA score, 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|1.91|||=|0.0209|TWO_SIDED|95.0|0.295|3.533||Same comment as above|ANCOVA||Same comment as above.|||3.533|0.295|=0.0209
71725047|NCT02851797|142965831|SUPERIORITY|Estimated cumulative failures, ratio of cumulative failures, CIs, and p-values are obtained from a negative binomial regression on the subject cumulative number of failures across all post-baseline visits. Total failed items at baseline, baseline values for: 4SC, time to rise from floor, time to run/walk 10 metres, distance walked in 6 minutes and re-derived age at first dose were included as independent covariates, with treatment group and steroid use included as indep classification factors.|Ratio of cumulative failures|0.61|||=|0.0202|TWO_SIDED|95.0|0.408|0.927||same comment as above|negative binomial regression model|Estimated cumulative failures, their ratio were obtained from a negative binomial regression on the cumulative N of failures across all visits.|"A lower ratio indicates a greater reduction in cumulative loss of function across 18 months for givinostat compared with placebo.~See also comment above."|||0.927|0.408|=0.0202
71725048|NCT02851797|142965832|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.19|||=|0.0902|TWO_SIDED|95.0|-0.03|0.401||same comment as above|ANCOVA||same comment as above|Overall knee extension||0.401|-0.030|=0.0902
71725049|NCT02851797|142965832|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in normalised muscle strength at Month 18 with baseline normalised muscle strength and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|0.09|||=|0.1818|TWO_SIDED|95.0|-0.041|0.213||same comment as above|ANCOVA||same comment as above|Overall elbow flexion||0.213|-0.041|=0.1818
71830358|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3973||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \< 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 7.1 months and high range of 15.6 months.~Conventional Care: low range of 4.4 and high range of 12.4 months."||||0.3973
71725050|NCT02851797|142965833|SUPERIORITY|LS Means, CIs, and p-values are obtained from an analysis of covariance (ANCOVA) model on change from baseline in VL MFF at Month 18 with baseline VL MFF and re-derived age at first dose fitted as covariates, with concomitant steroid use and treatment group as independent classification factors.|Difference in least square means|-2.92|||=|0.0354|TWO_SIDED|95.0|-5.641|-0.204||Same comment as above|ANCOVA||Same comment as above|||-0.204|-5.641|=0.0354
71725051|NCT04295681|142965839|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.0006|TWO_SIDED|95.0|0.47|1.7|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of MoCA scores (90th day of treatment minus baseline) were compared.||1.70|0.47|0.0006
71725052|NCT04295681|142965840|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.58|0.37|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 12th day of treatment) were compared.||0.37|-0.58|0.67
71725053|NCT04295681|142965840|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.94|TWO_SIDED|95.0|-0.47|0.5|||t-test, 2 sided||"Estimated value is calculated as MMH-MAP minus Placebo difference in mean MoCA scores changes."|Mean changes of NIHSS scores (baseline minus 90th day of treatment) were compared.||0.50|-0.47|0.94
71725054|NCT04295681|142965841|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Test for comparison percentage of patients with no significant disabilities after 90 days of treatment .||||0.89
71725055|NCT04295681|142965842|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect score comparison on 90th day of treatment.||||0.067
71725056|NCT04295681|142965842|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Side effects score comparison on 90th day of treatment.||||0.81
71657753|NCT02504671|142831745|OTHER||Difference|56.8|||||TWO_SIDED|95.0|40.1|73.4|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||73.4|40.1|
71725057|NCT04295681|142965842|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Efficacy index score comparison on 90th day of treatment.||||0.17
71725058|NCT04295681|142965843|SUPERIORITY|||||||0.656|||||||Fisher Exact|||The percentage of participants having at least one adverse event were compared.||||0.656
71725059|NCT04295681|142965844|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71725060|NCT04295681|142965846|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
71725061|NCT04295681|142965847|SUPERIORITY|||||||0.96|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.96
71725062|NCT04295681|142965848|SUPERIORITY|||||||0.438|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Systolic blood pressure. Analysis of varience (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.438
71725063|NCT04295681|142965848|SUPERIORITY|||||||0.56|||||||ANOVA|"P-value for interaction between factors Treatment and Visit is demonstrated."||"Diastolic blood pressure. Analysis of variance (ANOVA) for repeated measures has been used. Factors are Treatment, Visit and interaction Treatment-Visit. Significance of interaction as a factor representing difference in outcome value dynamics has been tested."||||0.56
71725064|NCT04295681|142965849|SUPERIORITY|||||||0.72|||||||Fisher Exact|||Comparison at the baseline.||||0.72
71725065|NCT04295681|142965849|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison on 90th day of treatment.||||1
71725066|NCT04295681|142965850|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71725067|NCT00803400|142965851|OTHER||Mean Difference (Final Values)|1.0|||<|0.001|ONE_SIDED||||||t-test, 1 sided|||A p-value less than 0.05 (≤ 0.05) is statistically significant. It indicates strong evidence against the null hypothesis, as there is less than a 5% probability the null is correct (and the results are random)||||<0.001
71725068|NCT02135029|142965868|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-60.1|-49.0|||MMRM|Mixed Model Repeated Measures (MMRM)|LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group\*visit interaction,baseline value, baseline value\*visit\*group interaction, country.|||-49.0|-60.1|<0.001
71725069|NCT02135029|142965869|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-42.6|-34.2|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-34.2|-42.6|<0.001
71725070|NCT02135029|142965869|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-35.9|-26.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-26.2|-35.9|
71725071|NCT02135029|142965870|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-51.9|-41.1|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-41.1|-51.9|<0.001
71725072|NCT02135029|142965870|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-45.4|-33.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-33.2|-45.4|
71725073|NCT02135029|142965871|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-56.3|-46.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-46.0|-56.3|<0.001
71725074|NCT02135029|142965871|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-47.7|-35.8|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-35.8|-47.7|
71657754|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71725075|NCT02135029|142965872|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.3|STANDARD_ERROR_OF_MEAN|6.32|<|0.001|TWO_SIDED|95.0|-35.7|-10.8|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-10.8|-35.7|<0.001
71725076|NCT02135029|142965872|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-29.6|-5.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-5.1|-29.6|
71725077|NCT02135029|142965873|SUPERIORITY_OR_OTHER||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|7.8|17.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||17.0|7.8|<0.001
71725078|NCT02135029|142965873|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|6.7|16.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||16.4|6.7|
71725079|NCT02135029|142965874|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.8|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-51.3|-38.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-38.2|-51.3|
71657755|NCT02504671|142831745|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
71830359|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 65 years~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 34.7 months.~Conventional Care: low range of 8.8 and high range of 16.4 months."||||<0.0001
71830360|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0707||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age \>= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 1.7 months and high range of 15.0 months.~Conventional Care: low range of 4.1 and high range of 7.6 months."||||0.0707
71830361|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0042||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Male~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 10.8 and high range of 17.2 months."||||0.0042
71830362|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0469||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Female~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 13.0 months and high range of 'does not exist'.~Conventional Care: low range of 8.2 and high range of 17.6 months."||||0.0469
71657756|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71657757|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657758|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657759|NCT02504671|142831745|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71657760|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657761|NCT02504671|142831745|OTHER||Difference|29.7|||||TWO_SIDED|95.0|13.8|45.7|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||45.7|13.8|
71725080|NCT02135029|142965875|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
71725081|NCT02135029|142965875|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
71657762|NCT02504671|142831745|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71657763|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657764|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657765|NCT02504671|142831745|OTHER||Difference|51.4|||||TWO_SIDED|95.0|34.5|68.2|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|34.5|
71725082|NCT02135029|142965876|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|2.2|10.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||10.1|2.2|
71725083|NCT02135029|142965876|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|1.5|9.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||9.7|1.5|
71657766|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71657767|NCT02504671|142831745|OTHER||Difference|35.1|||||TWO_SIDED|95.0|18.7|51.6|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||51.6|18.7|
71657768|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657769|NCT02504671|142831745|OTHER||Difference|18.9|||||TWO_SIDED|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||31.5|6.3|
71725084|NCT02135029|142965877|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|0.8|8.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.7|0.8|
71725085|NCT02135029|142965877|SUPERIORITY_OR_OTHER||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|2.4|10.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||10.5|2.4|
71725086|NCT02135029|142965878|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-5.2|-23.5|
71725087|NCT02135029|142965878|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.7|STANDARD_ERROR_OF_MEAN|5.14|||TWO_SIDED|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||0.4|-19.8|
71725088|NCT02135029|142965879|SUPERIORITY_OR_OTHER||LS Mean Difference|-93.8|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-103.5|-84.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-84.1|-103.5|
71725089|NCT02135029|142965880|SUPERIORITY_OR_OTHER||LS Mean Difference|-98.7|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-109.9|-87.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-87.5|-109.9|
71725090|NCT02135029|142965881|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|95.0|3.7|8.0|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||8.0|3.7|
71725091|NCT02135029|142965882|SUPERIORITY_OR_OTHER||LS Mean Difference|-103.6|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-114.6|-92.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-92.7|-114.6|
71725092|NCT02135029|142965884|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|-66.0|-52.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-52.4|-66.0|
71725093|NCT02135029|142965885|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-8.7|-4.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-4.5|-8.7|
71725094|NCT02135029|142965886|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-2.7|-2.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-2.1|-2.7|
71725095|NCT02135029|142965886|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-2.4|-1.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-1.7|-2.4|
71725096|NCT02135029|142965887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.5|-0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 12||-0.4|-0.5|
71725097|NCT02135029|142965887|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.4|-0.3|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group\* visit interaction, baseline value, baseline value\* visit\* group interaction, country.|Week 24||-0.3|-0.4|
71725098|NCT03525600|142965895|SUPERIORITY||LS Mean Difference|-0.2296||||0.0615|TWO_SIDED|95.0|-0.4703|0.0111|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0111|-0.4703|0.0615
71725099|NCT03525600|142965895|SUPERIORITY||LS Mean Difference|-0.2077||||0.0854|TWO_SIDED|95.0|-0.4444|0.029|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||0.0290|-0.4444|0.0854
71725100|NCT03525600|142965896|SUPERIORITY||LS Mean Difference|-0.7451||||0.0004|TWO_SIDED|95.0|-1.1539|-0.3362|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3362|-1.1539|0.0004
71725101|NCT03525600|142965896|SUPERIORITY||LS Mean Difference|-0.6331||||0.003|TWO_SIDED|95.0|-1.0508|-0.2153|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.2153|-1.0508|0.0030
71657770|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71725102|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0547||||0.4282|TWO_SIDED|95.0|-0.1899|0.0806|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0806|-0.1899|0.4282
71725103|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.0793||||0.2457|TWO_SIDED|95.0|-0.2131|0.0546|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0546|-0.2131|0.2457
71725104|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1722||||0.0292|TWO_SIDED|95.0|-0.327|-0.0174|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0174|-0.3270|0.0292
71725105|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1659||||0.0352|TWO_SIDED|95.0|-0.3202|-0.0115|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0115|-0.3202|0.0352
71725106|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.145||||0.0514|TWO_SIDED|95.0|-0.2909|0.0009|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||0.0009|-0.2909|0.0514
71725107|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.168||||0.0265|TWO_SIDED|95.0|-0.3164|-0.0196|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0196|-0.3164|0.0265
71725108|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.3532|||<|0.0001|TWO_SIDED|95.0|-0.5245|-0.1819|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1819|-0.5245|<0.0001
71725109|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2848||||0.0002|TWO_SIDED|95.0|-0.4336|-0.1361|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1361|-0.4336|0.0002
71830363|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 21.1 months and high range of 'does not exist'.~Conventional Care: low range of 9.3 and high range of 21.9 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0056
71830364|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"FAB: RAEB in transformation~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 11.7 months and high range of 'does not exist'.~Conventional Care: low range of 9.4 and high range of 17.0 months."||||0.0322
71725110|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7251||||0.0006|TWO_SIDED|95.0|-1.1373|-0.3129|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3129|-1.1373|0.0006
71725111|NCT03525600|142965897|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.698||||0.001|TWO_SIDED|95.0|-1.1142|-0.2817|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.2817|-1.1142|0.0010
71725112|NCT02438384|142965958|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|1.2|2.1||||||||2.1|1.2|
71725113|NCT02438384|142965958|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
71725114|NCT03319953|142965962|SUPERIORITY|||||||0.2079||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.2079
71725115|NCT03319953|142965962|SUPERIORITY|||||||0.0633||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>2.0.|Bayesian Normal Linear Model|||||||0.0633
71725116|NCT03319953|142965963|SUPERIORITY|||||||0.1706||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.1706
71725117|NCT03319953|142965963|SUPERIORITY|||||||0.0373||||||Bayesian method was used to calculate the posterior probability. High posterior probability of a difference between TAK-041 and placebo \>0.09.|Bayesian Normal Linear Model|||||||0.0373
71725118|NCT03315793|142965971|SUPERIORITY||Least squares mean difference|1.39||||0.5587|TWO_SIDED|98.0|-3.3|6.08|||mixed-effects model repeated measures|||||6.08|-3.30|0.5587
71725119|NCT03315793|142965972|SUPERIORITY||Risk Difference (RD)|5.4||||0.5111|TWO_SIDED|95.0|-10.7|21.5|||Cochran-Mantel-Haenszel|Stratified by age||||21.5|-10.7|0.5111
71725120|NCT03315793|142965973|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-13.5|13.5|||Cochran-Mantel-Haenszel|Stratified by age||||13.5|-13.5|1.0000
71725121|NCT03315793|142965974|SUPERIORITY||Risk Difference (RD)|-4.1||||0.4423|TWO_SIDED|95.0|-14.4|6.3|||Cochran-Mantel-Haenszel|Stratified by age||||6.3|-14.4|0.4423
71725122|NCT03315793|142965975|SUPERIORITY||Least squares mean difference|0.14||||0.3836|TWO_SIDED|95.0|-0.18|0.46|||mixed-effects model repeated measures|||||0.46|-0.18|0.3836
71725123|NCT02791191|142966039|SUPERIORITY|||||||0.418|||||||ANCOVA|||||||0.418
71725124|NCT02791191|142966039|SUPERIORITY|||||||0.231|||||||ANCOVA|||||||0.231
71725125|NCT02791191|142966040|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
71725126|NCT02791191|142966040|SUPERIORITY|||||||1|||||||Fisher Exact|||White Matter Disease||||1.000
71725127|NCT02791191|142966040|SUPERIORITY|||||||0.404|||||||Fisher Exact|||||||0.404
71725128|NCT02791191|142966040|SUPERIORITY|||||||1|||||||Fisher Exact|||Cortical Superficial Siderous||||1.000
71725129|NCT02791191|142966040|SUPERIORITY|Lacunar Infarct||||||1|||||||Fisher Exact|||||||1.000
71725130|NCT02791191|142966040|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Lacunar Infarct||||0.457
71725131|NCT02791191|142966040|SUPERIORITY|||||||1|||||||Fisher Exact|||Other Infarct||||1.000
71725132|NCT02791191|142966040|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Other Infarct||||0.457
71725133|NCT02791191|142966041|SUPERIORITY|||||||1|||||||Fisher Exact|||Vasogenic Edema||||1.000
71725134|NCT02791191|142966041|SUPERIORITY|||||||0.457|||||||Fisher Exact|||Vasogenic Edema||||0.457
71725135|NCT02791191|142966041|SUPERIORITY|||||||0.703|||||||Fisher Exact|||Increase in Microhemorrhage||||0.703
71725136|NCT02791191|142966041|SUPERIORITY|||||||1|||||||Fisher Exact|||Increase in Microhemorrhage||||1.000
71830365|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 6.6 months and high range of 'does not exist'.~Conventional Care: low range of 1.8 and high range of 9.8 months."||||0.1679
71830366|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB-2~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.9 months and high range of 'does not exist'.~Conventional Care: low range of 8.8 and high range of 19.4 months."||||0.0692
71830367|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: Other~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.6 months and high range of 'does not exist'.~Conventional Care: low range of 11.1 and high range of 17.5 months."||||0.0017
71830368|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 'does not exist'.~Conventional Care: low range of 8.7 and high range of 24.1 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.1030
71830369|NCT00071799|143165691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||"95% CI ranges are added here.~Azacitidine: low range of 15.0 months and high range of 'does not exist'.~Conventional Care: low range of 9.0 and high range of 17.0 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification||IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.||||0.0020
71830370|NCT00071799|143165692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.|Log Rank|||||||0.0025
71830371|NCT00071799|143165692|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.0027|TWO_SIDED|95.0|0.53|0.87|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.87|0.53|0.0027
71830372|NCT00071799|143165693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2555||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||0.2555
71830373|NCT00071799|143165693|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.2562|TWO_SIDED|95.0|0.6|1.15|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||1.15|0.60|0.2562
71830374|NCT00071799|143165694|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.||||<0.0001
71830375|NCT00071799|143165695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||0.0005
71830376|NCT00071799|143165696|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period||||1.000
71725137|NCT02791191|142966042|SUPERIORITY|||||||0.452|||||||Fisher Exact|||Treatment Emergent Suicidal Ideation||||0.452
71725138|NCT02791191|142966042|SUPERIORITY|||||||0.279||||||TE Suicidal Ideation|Fisher Exact|||||||0.279
71725139|NCT02791191|142966042|SUPERIORITY|||||||0.293|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.293
71725140|NCT02791191|142966042|SUPERIORITY|||||||0.486|||||||Fisher Exact|||Emergence of Suicidal Behavior||||0.486
71725141|NCT02791191|142966044|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta||||<.001
71725142|NCT02791191|142966044|SUPERIORITY|Amyloid Beta|||||<|0.001|||||||ANCOVA|||||||<.001
71725143|NCT02791191|142966044|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
71725144|NCT02791191|142966044|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-40||||<.001
71725145|NCT02791191|142966044|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
71725146|NCT02791191|142966044|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Amyloid Beta 1-42||||<.001
71725147|NCT02791191|142966045|SUPERIORITY|||||||0.97|||||||Mixed Model Repeated Measures|||||||0.970
71830377|NCT00071799|143165697|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||The p value is from Fisher's exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.||||<0.0001
71830378|NCT00071799|143165698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Fisher Exact|||Overall (Complete + Partial Remission)||||0.0001
71725148|NCT02791191|142966045|SUPERIORITY|||||||0.586|||||||Mixed Model Repeated Meausres|||||||0.586
71725149|NCT02791191|142966046|SUPERIORITY|||||||0.088|||||||ANCOVA|||||||0.088
71725150|NCT02791191|142966046|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.150
71725151|NCT02791191|142966047|SUPERIORITY|||||||0.153|||||||ANCOVA|||||||0.153
71725152|NCT02791191|142966047|SUPERIORITY|||||||0.176|||||||ANCOVA|||||||0.176
71725153|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean difference|26.28|||<|0.001|TWO_SIDED|95.0|20.33|32.22|||ANOVA|||Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.||32.22|20.33|<0.001
71725154|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.37|||<|0.001|TWO_SIDED|95.0|18.44|30.29|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.29|18.44|<0.001
71725155|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.48|||<|0.001|TWO_SIDED|95.0|21.53|33.42|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||33.42|21.53|<0.001
71725156|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|24.85|||<|0.001|TWO_SIDED|95.0|18.93|30.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||30.78|18.93|<0.001
71725157|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.42||||0.501|TWO_SIDED|95.0|-2.73|5.58|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.58|-2.73|0.501
71725158|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.817|TWO_SIDED|95.0|-4.61|3.64|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.64|-4.61|0.817
71725159|NCT01559259|142966138|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.62||||0.216|TWO_SIDED|95.0|-1.53|6.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|-1.53|0.216
71725160|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.69|||<|0.001|TWO_SIDED|95.0|5.52|29.19|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||29.19|5.52|<0.001
71770243|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0130
71770244|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0188||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0188
71770245|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6394||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6394
71725161|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|10.02|||<|0.001|TWO_SIDED|95.0|4.36|23.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||23.02|4.36|<0.001
71725162|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.66|||<|0.001|TWO_SIDED|95.0|5.07|26.83|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||26.83|5.07|<0.001
71770246|NCT00282464|143040267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7707||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7707
71770247|NCT00282464|143040268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2185||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2185
71770248|NCT00282464|143040268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4124||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.4124
71725163|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.6|||<|0.001|TWO_SIDED|95.0|3.74|19.77|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||19.77|3.74|<0.001
71725164|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.48||||0.014|TWO_SIDED|95.0|1.08|2.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||2.02|1.08|0.014
71725165|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.332|TWO_SIDED|95.0|0.86|1.59|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.59|0.86|0.332
71830379|NCT00071799|143165698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||95.0|||||Fisher Exact|||Complete remission||||0.0150
71770249|NCT00282464|143040268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6098
71725166|NCT01559259|142966139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36||||0.056|TWO_SIDED|95.0|0.99|1.85|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.||1.85|0.99|0.056
71770250|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.0005
71770251|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.0099
71770252|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0423||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0423
71770253|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0618||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.0618
71770254|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0451||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0451
71725167|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|12.1|||<|0.001|TWO_SIDED|95.0|5.24|27.91|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||27.91|5.24|<0.001
71725168|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.88|||<|0.001|TWO_SIDED|95.0|3.86|20.44|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||20.44|3.86|<0.001
71770255|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2633||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.2633
71770256|NCT00282464|143040269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2206||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.2206
71770257|NCT00282464|143040270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9863||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.9863
71725169|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|11.47|||<|0.001|TWO_SIDED|95.0|4.98|26.42|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||26.42|4.98|<0.001
71725170|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|8.11|||<|0.001|TWO_SIDED|95.0|3.52|18.68|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||18.68|3.52|<0.001
71770258|NCT00282464|143040270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1017||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.1017
71770259|NCT00282464|143040270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4033||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.4033
71770260|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||No multiple comparison adjustment is applicable. Statistical significance level was 0.05|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.002
71770261|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.019
71770262|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.038
71770263|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.069
71770264|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.053
71725171|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.012|TWO_SIDED|95.0|1.09|2.04|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||2.04|1.09|0.012
71725172|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.57|TWO_SIDED|95.0|0.8|1.49|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.49|0.80|0.570
71725173|NCT01559259|142966140|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.41||||0.03|TWO_SIDED|95.0|1.03|1.93|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.||1.93|1.03|0.030
71725174|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.014|TWO_SIDED|95.0|0.08|0.71|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.71|0.08|0.014
71725175|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.038|TWO_SIDED|95.0|0.02|0.64|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.02|0.038
71770265|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.||||0.154
71770266|NCT00282464|143040271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.007
71770267|NCT00282464|143040272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.112
71725176|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.003|TWO_SIDED|95.0|0.17|0.79|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.17|0.003
71725177|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.155|TWO_SIDED|95.0|-0.09|0.54|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.09|0.155
71725178|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.135|TWO_SIDED|95.0|-0.05|0.39|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.05|0.135
71725179|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.11|0.350
71725180|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|0.03|0.024
71725181|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|0.9|1.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.77|0.90|<0.001
71725182|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.26|||<|0.001|TWO_SIDED|95.0|0.83|1.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|0.83|<0.001
71725183|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35||||0.001|TWO_SIDED|95.0|0.91|1.78|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.91|0.001
71725184|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.43|1.3|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|0.43|<0.001
71725185|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.003|TWO_SIDED|95.0|0.16|0.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|0.16|0.003
71725186|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.01|TWO_SIDED|95.0|0.1|0.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.10|0.010
71770268|NCT00282464|143040272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.352
71770269|NCT00282464|143040272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.873
71830380|NCT00071799|143165698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094||95.0|||||Fisher Exact|||Partial Remission||||0.0094
71725187|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.18|0.002
71725188|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.12|||<|0.001|TWO_SIDED|95.0|1.66|2.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.66|<0.001
71725189|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.96|||<|0.001|TWO_SIDED|95.0|1.5|2.42|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.42|1.50|<0.001
71725190|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.14|||<|0.001|TWO_SIDED|95.0|1.67|2.6|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.60|1.67|<0.001
71725191|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.74|||<|0.001|TWO_SIDED|95.0|1.28|2.2|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.20|1.28|<0.001
71725192|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.022|TWO_SIDED|95.0|0.05|0.7|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.70|0.05|0.022
71725193|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.181|TWO_SIDED|95.0|-0.1|0.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.10|0.181
71725194|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.4||||0.016|TWO_SIDED|95.0|0.07|0.72|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.07|0.016
71725195|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.43|||<|0.001|TWO_SIDED|95.0|1.98|2.88|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.88|1.98|<0.001
71725196|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.72|2.62|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.62|1.72|<0.001
71725197|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46|||<|0.001|TWO_SIDED|95.0|2.01|2.91|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|2.01|<0.001
71725198|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.13|||<|0.001|TWO_SIDED|95.0|1.68|2.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.68|<0.001
71725199|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.065|TWO_SIDED|95.0|-0.02|0.61|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.02|0.065
71770270|NCT00282464|143040273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.305
71725200|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.817|TWO_SIDED|95.0|-0.28|0.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.28|0.817
71770271|NCT00282464|143040273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.510
71830381|NCT00071799|143165698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3297||95.0|||||Fisher Exact|||Stable Disease||||0.3297
71830382|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Any Improvement||||<0.0001
71830383|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Fisher Exact|||Erythroid Response - Major||||<0.0001
71830384|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6203||95.0|||||Fisher Exact|||Erythroid Response - Minor||||0.6203
71830385|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Fisher Exact|||Platelet Response - Major||||0.0003
71830386|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7514||95.0|||||Fisher Exact|||Platelet Response - Minor||||0.7514
71830387|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8695||95.0|||||Fisher Exact|||Neutrophil Response - Major||||0.8695
71830388|NCT00071799|143165699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Fisher Exact|||Neutrophil Response - Minor||||0.1760
71830389|NCT00071799|143165700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0466
71830390|NCT00071799|143165700|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0474|TWO_SIDED|95.0|0.53|1.0|||Regression, Cox|||||1.00|0.53|0.0474
71725201|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.043|TWO_SIDED|95.0|0.01|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.64|0.01|0.043
71830391|NCT00071799|143165701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank|||||||0.0002
71830392|NCT00071799|143165702|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.67||||0.1327|TWO_SIDED|95.0|0.35|1.2|||exact binomial|||||1.20|0.35|0.1327
71830393|NCT00071799|143165704|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||||||<0.0001
71830394|NCT00071799|143165704|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.35|0.7|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.|||0.70|0.35|<0.0001
71725202|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.06|3.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.06|<0.001
71830395|NCT04532528|143165721|OTHER|No formal hypotheses were tested.||||||0.9701|||||||Chi-squared|||||||0.9701
71830396|NCT04532528|143165722|OTHER|No formal hypotheses were tested.||||||0.7376|||||||Chi-squared|||At 3 months only||||0.7376
71830397|NCT04532528|143165722|OTHER|No formal hypotheses were tested.||||||0.1356|||||||Chi-squared|||At 6 months only||||0.1356
71830398|NCT04532528|143165722|OTHER|No formal hypotheses were tested.||||||0.68|||||||Chi-squared|||At 9 months only||||0.6800
71830399|NCT04532528|143165723|OTHER|No formal hypotheses were tested.||||||0.5777|||||||Chi-squared|||At 3 months only||||0.5777
71830400|NCT04532528|143165723|OTHER|No formal hypotheses were tested.||||||0.3313|||||||Chi-squared|||At 6 months only||||0.3313
71725203|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.87|2.82|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.82|1.87|<0.001
71725204|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63|||<|0.001|TWO_SIDED|95.0|2.15|3.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.11|2.15|<0.001
71725205|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.36|||<|0.001|TWO_SIDED|95.0|1.89|2.84|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.84|1.89|<0.001
71725206|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.312|TWO_SIDED|95.0|-0.16|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-0.16|0.312
71725207|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.35|0.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.35|0.910
71830401|NCT04532528|143165723|OTHER|No formal hypotheses was tested.||||||0.5697|||||||Chi-squared|||At 9 months only||||0.5697
71830402|NCT04532528|143165723|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Chi-squared|||At 12 months only||||0.5135
71830403|NCT04532528|143165724|OTHER|No formal hypotheses were tested.||||||0.8509|||||||Chi-squared|||At 3 months only||||0.8509
71830404|NCT04532528|143165724|OTHER|No formal hypotheses were tested.||||||0.3302|||||||Chi-squared|||At 6 months only||||0.3302
71830405|NCT04532528|143165724|OTHER|No formal hypotheses was tested.||||||0.9005|||||||Chi-squared|||At 9 months only||||0.9005
71830406|NCT04532528|143165724|OTHER|No formal hypotheses were tested.||||||0.2789|||||||Chi-squared|||At 12 months only||||0.2789
71830407|NCT04532528|143165725|OTHER|No formal hypotheses were tested.||||||0.667|||||||Wilcoxon (Mann-Whitney)|||At 3 months only||||0.6670
71830408|NCT04532528|143165725|OTHER|||||||0.1285|||||||Wilcoxon (Mann-Whitney)|||At 6 months only||||0.1285
71830409|NCT04532528|143165725|OTHER|No formal hypotheses was tested.||||||0.7151|||||||Wilcoxon (Mann-Whitney)|||At 9 months only||||0.7151
71830410|NCT04532528|143165725|OTHER|No formal hypotheses were tested||||||0.803|||||||Wilcoxon (Mann-Whitney)|||At 12 months only||||0.8030
71830411|NCT01636687|143165729|SUPERIORITY_OR_OTHER||Risk Difference (RD)|53.3|||<|0.0001|TWO_SIDED|95.0|36.6|67.7|||Fisher Exact|||Response criterion: IGA 0/1||67.7|36.6|<0.0001
71830412|NCT01636687|143165729|SUPERIORITY_OR_OTHER||Risk Difference (RD)|73.3|||<|0.0001|TWO_SIDED|95.0|58.8|83.9|||Fisher Exact|||Response Criterion: IGA 0/1||83.9|58.8|<0.0001
71830413|NCT01636687|143165729|SUPERIORITY_OR_OTHER||Risk Difference (RD)|68.4|||<|0.0001|TWO_SIDED|95.0|53.1|79.8|||Fisher Exact|||Response criterion: PASI 75||79.8|53.1|<0.0001
71830414|NCT01636687|143165729|SUPERIORITY_OR_OTHER||Risk Difference (RD)|83.4|||<|0.0001|TWO_SIDED|95.0|70.7|91.7|||Fisher Exact|||Response criterion: PASI 75||91.7|70.7|<0.0001
71830415|NCT03593213|143165757|SUPERIORITY||Hazard Ratio (HR)|0.56|||=|0.1576|TWO_SIDED|95.0|0.25|1.29||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.29|0.25|=0.1576
71830416|NCT03593213|143165757|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.2066|TWO_SIDED|95.0|0.26|1.45||The significance level was 0.05 using the log rank test.|Log Rank||Hazard ratio (cariprazine 3.0 or 4.5 mg/day vs. placebo) was based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||1.45|0.26|=0.2066
71830417|NCT02658240|143165758|SUPERIORITY|||||||0.05|||||||ANOVA|||The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.||||0.05
71830418|NCT02658240|143165759|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
71725208|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.113|TWO_SIDED|95.0|-0.06|0.6|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.06|0.113
71725209|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.48|||<|0.001|TWO_SIDED|95.0|1.98|2.97|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|1.98|<0.001
71725210|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.76|2.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.75|1.76|<0.001
71725211|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|2.02|3.01|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.01|2.02|<0.001
71725212|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.35|||<|0.001|TWO_SIDED|95.0|1.86|2.85|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.85|1.86|<0.001
71725213|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.482|TWO_SIDED|95.0|-0.22|0.47|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.22|0.482
71725214|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.573|TWO_SIDED|95.0|-0.44|0.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.24|-0.44|0.573
71725215|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.368|TWO_SIDED|95.0|-0.19|0.5|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.19|0.368
71725216|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.88|2.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.91|1.88|<0.001
71725217|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.66|2.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.68|1.66|<0.001
71725218|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.44|||<|0.001|TWO_SIDED|95.0|1.93|2.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.96|1.93|<0.001
71725219|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.74|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.74|1.72|<0.001
71725220|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.352|TWO_SIDED|95.0|-0.19|0.53|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.19|0.352
71725221|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.771|TWO_SIDED|95.0|-0.41|0.3|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.41|0.771
71725222|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.235|TWO_SIDED|95.0|-0.14|0.58|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|-0.14|0.235
71725223|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.32|||<|0.001|TWO_SIDED|95.0|1.79|2.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.79|<0.001
71725224|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.05|||<|0.001|TWO_SIDED|95.0|1.52|2.58|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.58|1.52|<0.001
71725225|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.37|||<|0.001|TWO_SIDED|95.0|1.83|2.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|1.83|<0.001
71725226|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.2|||<|0.001|TWO_SIDED|95.0|1.66|2.73|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.73|1.66|<0.001
71725227|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.51|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.25|0.510
71830419|NCT02658240|143165760|SUPERIORITY|||||||0.149|TWO_SIDED|80.0|||||t-test, 2 sided|||||||0.149
71830420|NCT02658240|143165761|SUPERIORITY|||||||0.584|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.584
71830421|NCT04589689|143165785|OTHER|||||||0.777||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3 months.||||0.777
71830422|NCT04589689|143165785|OTHER|||||||0.247||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month.||||0.247
71725228|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.442|TWO_SIDED|95.0|-0.52|0.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.52|0.442
71725229|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.17||||0.372|TWO_SIDED|95.0|-0.2|0.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.20|0.372
71725230|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.55|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.55|1.39|<0.001
71725231|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.25|2.4|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.40|1.25|<0.001
71725232|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.57|2.72|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|1.57|<0.001
71725233|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.87|||<|0.001|TWO_SIDED|95.0|1.3|2.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|1.30|<0.001
71725234|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.639|TWO_SIDED|95.0|-0.31|0.5|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.31|0.639
71725235|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.803|TWO_SIDED|95.0|-0.45|0.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.45|0.803
71725236|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.184|TWO_SIDED|95.0|-0.13|0.67|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.67|-0.13|0.184
71725237|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.67|||<|0.001|TWO_SIDED|95.0|1.07|2.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|1.07|<0.001
71725238|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.58|||<|0.001|TWO_SIDED|95.0|0.99|2.17|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.17|0.99|<0.001
71725239|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.25|2.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.43|1.25|<0.001
71725240|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.69|||<|0.001|TWO_SIDED|95.0|1.1|2.28|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.28|1.10|<0.001
71725241|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.02||||0.91|TWO_SIDED|95.0|-0.44|0.39|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.44|0.910
71725242|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.607|TWO_SIDED|95.0|-0.52|0.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.52|0.607
71725243|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.484|TWO_SIDED|95.0|-0.27|0.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.56|-0.27|0.484
71725244|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.64|1.86|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.64|<0.001
71725245|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.75|1.97|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|0.75|<0.001
71725246|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|0.77|1.99|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.99|0.77|<0.001
71725247|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|0.89|2.1|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.10|0.89|<0.001
71725248|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.256|TWO_SIDED|95.0|-0.67|0.18|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.18|-0.67|0.256
71725249|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.526|TWO_SIDED|95.0|-0.56|0.29|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|-0.56|0.526
71888078|NCT01228903|143297016|EQUIVALENCE|(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.|Mean Difference (Net)|0.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The estimated value represents the difference between the change from baseline in both groups.|The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.||||0.47
71888079|NCT02867761|143297022|SUPERIORITY||Odds Ratio (OR)|0.91||||0.65|TWO_SIDED|95.0|0.6|1.37|||Generalized Estimating Equation|||||1.37|0.60|0.65
71888080|NCT02867761|143297026|SUPERIORITY|||||||0.3|||||||Linear Mixed Effects Model|||||||0.30
71725250|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.602|TWO_SIDED|95.0|-0.54|0.31|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.54|0.602
71725251|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.34|1.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.34|0.002
71770272|NCT00282464|143040273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.710
71770273|NCT00282464|143040274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.026
71770274|NCT00282464|143040274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.223
71770275|NCT00282464|143040274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.848||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.848
71888081|NCT02867761|143297027|SUPERIORITY|||||||0.49|||||||Linear Mixed Effects Model|||||||0.49
71725252|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.98||||0.001|TWO_SIDED|95.0|0.38|1.59|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.59|0.38|0.001
71770276|NCT00282464|143040275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.381
71770277|NCT00282464|143040275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.676||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.676
71770278|NCT00282464|143040275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.295
71770279|NCT00282464|143040276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.068
71770280|NCT00282464|143040276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.043
71888082|NCT02867761|143297028|SUPERIORITY|||||||0.96|||||||Linear Mixed Effects Model|||||||0.96
71888083|NCT02867761|143297029|SUPERIORITY||||||<|0.001|||||||Linear Mixed Effects Model|||||||<0.001
71888084|NCT02867761|143297032|SUPERIORITY|||||||0.35|||||||Linear Mixed Effects Model|||P Value for percentage of days with any symptoms (shortness of breath, chest tightness, wheezing, cough, or sputum)||||0.35
71770281|NCT00282464|143040276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.404||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.404
71770282|NCT00282464|143040277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.899
71888085|NCT02867761|143297032|SUPERIORITY|||||||0.61|||||||Linear Mixed Effects Model|||P Value for percentage of days with shortness of breath||||0.61
71888086|NCT02867761|143297032|SUPERIORITY|||||||0.48|||||||Linear Mixed Effects Model|||P Value for percentage of days with chest tightness||||0.48
71888087|NCT02867761|143297032|SUPERIORITY|||||||0.81|||||||Linear Mixed Effects Model|||P Value for percentage of days with wheezing||||0.81
71888088|NCT02867761|143297032|SUPERIORITY|||||||0.17|||||||Linear Mixed Effects Model|||P Value for percentage of days with cough||||0.17
71888089|NCT02867761|143297032|SUPERIORITY|||||||0.64|||||||Linear Mixed Effects Model|||P Value for percentage of days with sputum||||0.64
71888090|NCT02867761|143297032|SUPERIORITY|||||||0.84|||||||Linear Mixed Effects Model|||P Value for percentage of days with use of albuterol.||||0.84
71888091|NCT04506294|143297040|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||.536
71888092|NCT00428597|143297087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.000118|TWO_SIDED|95.0|0.263|0.662||Log-rank test statistic and 2-sided p-value from the unstratified log-rank test|Log Rank||Hazard ratio based on the Cox Proportional hazards model|||0.662|0.263|0.000118
71725253|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.25|||<|0.001|TWO_SIDED|95.0|0.65|1.86|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|0.65|<0.001
71725254|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.22|||<|0.001|TWO_SIDED|95.0|0.61|1.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|0.61|<0.001
71725255|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.26||||0.224|TWO_SIDED|95.0|-0.69|0.16|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.69|0.224
71830423|NCT04589689|143165786|OTHER|||||||0.16||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.160
71888093|NCT00428597|143297088|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|9.3|||||TWO_SIDED|95.0|4.1|17.5|||||Confidence interval (CI) using exact method based on binomial distribution.|||17.5|4.1|
71725256|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.283|TWO_SIDED|95.0|-0.65|0.19|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.65|0.283
71725257|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.86|TWO_SIDED|95.0|-0.39|0.46|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.46|-0.39|0.860
71725258|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.038|TWO_SIDED|95.0|0.03|1.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.03|0.038
71725259|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.65||||0.031|TWO_SIDED|95.0|0.06|1.24|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.06|0.031
71725260|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.43|1.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.62|0.43|<0.001
71725261|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.95||||0.002|TWO_SIDED|95.0|0.36|1.54|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.54|0.36|0.002
71725262|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.32||||0.129|TWO_SIDED|95.0|-0.74|0.09|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.09|-0.74|0.129
71725263|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.3||||0.154|TWO_SIDED|95.0|-0.71|0.11|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.11|-0.71|0.154
71725264|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.714|TWO_SIDED|95.0|-0.34|0.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.34|0.714
71725265|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.217|TWO_SIDED|95.0|-0.22|0.96|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.96|-0.22|0.217
71725266|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.136|TWO_SIDED|95.0|-0.14|1.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.03|-0.14|0.136
71725267|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.37|0.19|0.010
71725268|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.006|TWO_SIDED|95.0|0.24|1.41|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.24|0.006
71725269|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.031|TWO_SIDED|95.0|-0.87|-0.04|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.87|0.031
71725270|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.38||||0.07|TWO_SIDED|95.0|-0.79|0.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.03|-0.79|0.070
71725271|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.822|TWO_SIDED|95.0|-0.46|0.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-0.46|0.822
71830424|NCT04589689|143165786|OTHER|||||||0.275||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.275
71830425|NCT04589689|143165787|OTHER|||||||0.509||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.509
71830426|NCT04589689|143165787|OTHER|||||||0.61||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.610
71770283|NCT00282464|143040277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.739
71830427|NCT04589689|143165788|OTHER|||||||0.807||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.807
71830428|NCT04589689|143165788|OTHER|||||||0.826||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.826
71830429|NCT04589689|143165789|OTHER|||||||0.076||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.076
71830430|NCT04589689|143165789|OTHER|||||||0.747||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.747
71830431|NCT04589689|143165790|OTHER|||||||0.154||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.154
71830432|NCT04589689|143165790|OTHER|||||||0.107||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.107
71830433|NCT04589689|143165791|OTHER|||||||0.445||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 3-month follow-up.||||0.445
71830434|NCT04589689|143165791|OTHER|||||||0.543||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.543
71830435|NCT04589689|143165792|OTHER|||||||0.157||||||The a priori threshold for statistical significance is \<.05.|t-test, 2 sided|||Analysis at 6-month follow-up.||||0.157
71830436|NCT01039688|143165820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0014|TWO_SIDED|95.0|-0.73|-0.18||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.18|-0.73|0.0014
71830437|NCT01039688|143165820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.0004|TWO_SIDED|95.0|-0.77|-0.23||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA|||||-0.23|-0.77|0.0004
71830438|NCT01039688|143165821|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.32|||<|0.0001|TWO_SIDED|95.0|6.81|19.82||A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||19.82|6.81|<0.0001
71770284|NCT00282464|143040277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.797||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.797
71770285|NCT00282464|143040278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.434
71770286|NCT00282464|143040278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.777||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.777
71830439|NCT01039688|143165821|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.25|||<|0.0001|TWO_SIDED|95.0|18.51|31.99||A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation|||||31.99|18.51|<0.0001
71830440|NCT03844269|143165926|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||EEG data excluded if excessive noise (rejection of more than 30% of target trials due to voltage fluctuations greater than ± 100 μV deflections within an epoch) at the pre- or post-intervention assessment||||<0.05
71830441|NCT02384070|143165936|SUPERIORITY_OR_OTHER|||||||1||||||Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.|ANOVA|||||||1
71830442|NCT02384070|143165936|SUPERIORITY_OR_OTHER|||||||1||||||The prior threshold for statistical significance was P \< 0.05|ANOVA|||||||1
71830443|NCT02755116|143165955|SUPERIORITY||Adjusted relative risk|0.76||||0.003|TWO_SIDED|95.0|0.48|1.2|||log-binomial regression|||||1.20|0.48|0.003
71830444|NCT02214160|143165960|SUPERIORITY|||||||0.0347|||||||Paired T-test|||||||0.0347
71830445|NCT02214160|143165961|SUPERIORITY|||||||0.0343|||||||Wilcoxon Signed Rank Test|||||||0.0343
71830446|NCT02423798|143165977|OTHER||Mean|9.13|||||TWO_SIDED|||||||||||||
71830447|NCT01063972|143165980|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71830448|NCT01063972|143165981|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
71830449|NCT01063972|143165982|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
71830450|NCT01063972|143165983|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
71830451|NCT06243796|143166020|SUPERIORITY||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71830452|NCT06243796|143166021|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71830453|NCT00696618|143166022|SUPERIORITY_OR_OTHER||||||<|0.05||||||Adjusted for multiple comparisons.|multi-level|||Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.||||<.05
71830454|NCT00696618|143166023|SUPERIORITY_OR_OTHER||||||<|0.05|||||||multi-level|||||||<.05
71830455|NCT00696618|143166024|SUPERIORITY_OR_OTHER||||||<|0.05|||||||mulit-level analysis|||||||<.05
71888094|NCT00428597|143297091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.409||||0.0204|TWO_SIDED|95.0|0.187|0.894||2-sided p-value from the unstratified log-rank test.|Log Rank||Hazard ratio based on the Cox Proportional hazards model.|||0.894|0.187|0.0204
71830456|NCT00940537|143166031|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||a priori threshhold for significance was set at p\<0.05.|t-test, 2 sided|this was a paired t-test||As there was no a priori reason for the level of IHTG to impact this measurement we compared the pre and post-prandial results for all subjects whose data were of sufficient quality (N=12). These results are comparing the two categories of fasting and post-prandial. Null hypothesis was that there would be no difference in IHTG before and after a high fat, high carbohydrate meal.||||.097
71830457|NCT00940537|143166032|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This p-value compares the low IHTG (\<5%) subjects to those with medium levels of IHTG (5 - 10%). The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intrahepatic triglyceride (IHTG) and would be equal for the low and medium IHTG categories.||||0.006
71725272|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.327|TWO_SIDED|95.0|-0.28|0.83|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.28|0.327
71725273|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.34||||0.224|TWO_SIDED|95.0|-0.21|0.89|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.89|-0.21|0.224
71725274|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.63||||0.025|TWO_SIDED|95.0|0.08|1.19|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|0.08|0.025
71725275|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7||||0.012|TWO_SIDED|95.0|0.15|1.25|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|0.15|0.012
71725276|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.43||||0.03|TWO_SIDED|95.0|-0.81|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-0.81|0.030
71725277|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.064|TWO_SIDED|95.0|-0.75|0.02|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.02|-0.75|0.064
71725278|NCT01559259|142966141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.721|TWO_SIDED|95.0|-0.46|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-0.46|0.721
71725279|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.02|0.033
71725280|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.224|TWO_SIDED|95.0|-0.08|0.33|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.08|0.224
71725281|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.024|TWO_SIDED|95.0|0.03|0.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|0.03|0.024
71725282|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.501|TWO_SIDED|95.0|-0.13|0.27|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.27|-0.13|0.501
71725283|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.036|TWO_SIDED|95.0|0.01|0.29|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.29|0.01|0.036
71725284|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.08|0.435
71725285|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.023|TWO_SIDED|95.0|0.02|0.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|0.02|0.023
71725286|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.52|1.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|0.52|<0.001
71725287|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.37|0.97|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|0.37|<0.001
71725288|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74|||<|0.001|TWO_SIDED|95.0|0.45|1.04|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|0.45|<0.001
71725289|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.003|TWO_SIDED|95.0|0.16|0.75|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|0.16|0.003
71725290|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37|||<|0.001|TWO_SIDED|95.0|0.16|0.58|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.58|0.16|<0.001
71770287|NCT00282464|143040278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.820
71770288|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.468
71770289|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.110
71770290|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.738
71770291|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.617
71770292|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.642||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.642
71770293|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.644
71770294|NCT00282464|143040279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.789||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.789
71770295|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.042
71770296|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.088
71770297|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.651||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.651
71770298|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.665
71770299|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.349
71770300|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.685
71770301|NCT00282464|143040280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.257||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.257
71770302|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 1||||0.0099
71830458|NCT00940537|143166032|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (\<5%) and high (\>10%) IHTG categories.||||<0.0001
71770303|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 2||||0.0654
71770304|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1807||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 3||||0.1807
71770305|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0957||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 4||||0.0957
71770306|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0752||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 5||||0.0752
71770307|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3964||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Week 6||||0.3964
71770308|NCT00282464|143040281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction.||Overall||||0.0287
71770309|NCT00282464|143040282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.965||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.965
71770310|NCT00282464|143040283|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint||||0.860
71770311|NCT00282464|143040284|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Baseline to endpoint||||0.428
71770312|NCT00282464|143040285|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status||Change from baseline to endpoint||||0.708
71770313|NCT00282464|143040286|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.898
71770314|NCT00282464|143040287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.559
71770315|NCT00282464|143040288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458||||||For all secondary efficacy analyses, no multiple adjustments were made|ANOVA|ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint||||0.458
71770316|NCT04391569|143040323|OTHER|||||||0||||||P-value from logistic regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.0000
71770317|NCT04391569|143040324|OTHER|||||||0.1619||||||P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|P-value is derive by fixed weight (2/3 for interim and 1/3 for post interim) combination test.||||||0.1619
71830459|NCT00940537|143166032|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||The a priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (\<10%) IHTG groups would not be statistically different with regard to average T2 ratio.||||.93
71770318|NCT04391569|143040326|OTHER|||||||0.2097|||||||fixed weight combination test|||||||0.2097
71770319|NCT04391569|143040327|OTHER|||||||0|||||||Log Rank|||||||0.0000
71770320|NCT04391569|143040328|OTHER|||||||0.0075||||||P-value is derived by fixed weight (2/3 for interim and 1/3 for post interim) combination test. P-value from logistics regression is used for interim data, and Boschloo's test p-value is used for post interim data.|fixed weight combination test|||||||0.0075
71770321|NCT00773838|143040346|OTHER|||||||0.419|||||||Exact Test for Binomial Parameter|||||||0.419
71770322|NCT02674854|143040376|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
71830460|NCT01415349|143166037|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.966|1.09|||Mixed Models Analysis|||||1.09|0.966|
71770323|NCT02674854|143040376|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
71770324|NCT02889562|143040390|OTHER|Pearson chi-squared tests or Fisher exact tests||||||1|||||||Chi-squared|||||||1.0
71770325|NCT02889562|143040393|OTHER|t-test and Wilcoxon analysis||||||0.17|||||||t-test, 1 sided|||||||0.17
71770326|NCT01943474|143040395|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71770327|NCT01943474|143040396|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71770328|NCT01943474|143040397|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71770329|NCT01943474|143040398|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71770330|NCT01943474|143040399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71770331|NCT01943474|143040402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71770332|NCT01943474|143040403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71770333|NCT02119676|143040413|OTHER||Hazard Ratio (HR)|1.04||||0.588|TWO_SIDED|95.0|0.73|1.49||1-sided|Log Rank|Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.|Estimated using a Cox regression model with Efron's method used for ties, stratified by mGPS score and geographical region|||1.49|0.73|0.588
71770334|NCT02119676|143040413|OTHER||Hazard Ratio (HR)|0.77||||0.136|TWO_SIDED|95.0|0.48|1.23||1-sided|Log Rank|Log rank test stratified by geographical region.|Estimated using Cox regression model with Efron's method used for ties, stratified by geographical region|||1.23|0.48|0.136
71770335|NCT02216812|143040422|OTHER|||||||0.63|||||||Regression, Linear|||We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.||||0.63
71830461|NCT01415349|143166038|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.998|1.08|||Mixed Models Analysis|||||1.08|0.998|
71888095|NCT00428597|143297092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1543||||0.6799|TWO_SIDED|95.0|-4.3|6.6||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.6|-4.3|0.6799
71725291|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.039|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|0.01|0.039
71725292|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.006|TWO_SIDED|95.0|0.08|0.5|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|0.08|0.006
71725293|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.33|||<|0.001|TWO_SIDED|95.0|1.01|1.65|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.65|1.01|<0.001
71725294|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.85|1.49|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|0.85|<0.001
71725295|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.03|1.67|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.03|<0.001
71725296|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.72|1.36|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.36|0.72|<0.001
71725297|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.011|TWO_SIDED|95.0|0.07|0.52|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|0.07|0.011
71725298|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.267|TWO_SIDED|95.0|-0.1|0.35|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.10|0.267
71725299|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.007|TWO_SIDED|95.0|0.09|0.53|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|0.09|0.007
71725300|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.24|1.89|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.24|<0.001
71725301|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.38|||<|0.001|TWO_SIDED|95.0|1.06|1.7|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|1.06|<0.001
71725302|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.25|<0.001
71725303|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.35|||<|0.001|TWO_SIDED|95.0|1.02|1.67|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.67|1.02|<0.001
71725304|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.056|TWO_SIDED|95.0|-0.01|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.01|0.056
71725305|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.759|TWO_SIDED|95.0|-0.19|0.26|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.26|-0.19|0.759
71725306|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.23||||0.051|TWO_SIDED|95.0|0.0|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.00|0.051
71725307|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.3|1.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.30|<0.001
71725308|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.18|1.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.18|<0.001
71725309|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.71|||<|0.001|TWO_SIDED|95.0|1.37|2.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.05|1.37|<0.001
71725310|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.52|||<|0.001|TWO_SIDED|95.0|1.19|1.86|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.19|<0.001
71725311|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.342|TWO_SIDED|95.0|-0.12|0.35|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-0.12|0.342
71830462|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.9|0.75|1.07||||||ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.07|0.75|
71888096|NCT00428597|143297093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4404||||0.6058|TWO_SIDED|95.0|-6.9|4.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4|-6.9|0.6058
71725312|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.01||||0.943|TWO_SIDED|95.0|-0.24|0.23|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.24|0.943
71725313|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.18||||0.126|TWO_SIDED|95.0|-0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.42|-0.05|0.126
71725314|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.27|1.98|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|1.27|<0.001
71725315|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5|||<|0.001|TWO_SIDED|95.0|1.15|1.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.86|1.15|<0.001
71725316|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.64|||<|0.001|TWO_SIDED|95.0|1.29|2.0|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.00|1.29|<0.001
71725317|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.18|1.89|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.89|1.18|<0.001
71725318|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.453|TWO_SIDED|95.0|-0.15|0.34|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.15|0.453
71725319|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.816|TWO_SIDED|95.0|-0.28|0.22|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.28|0.816
71770336|NCT00266864|143040428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|2.7|<|0.01|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in lean tissue mass across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||<0.01
71725320|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.11||||0.384|TWO_SIDED|95.0|-0.14|0.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.36|-0.14|0.384
71725321|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.55|||<|0.001|TWO_SIDED|95.0|1.19|1.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.91|1.19|<0.001
71725322|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
71725323|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.61|||<|0.001|TWO_SIDED|95.0|1.25|1.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.97|1.25|<0.001
71725324|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.46|||<|0.001|TWO_SIDED|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.82|1.10|<0.001
71888097|NCT00428597|143297094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5575||||0.3008|TWO_SIDED|95.0|-10.3|3.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||3.2|-10.3|0.3008
71770337|NCT00266864|143040429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|101.0|STANDARD_DEVIATION|103.0||0.051|TWO_SIDED|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 \[(month 12- baseline)/baseline\*100\] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in resting energy expenditure across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.||||0.051
71770338|NCT03050775|143040448|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
71770339|NCT03050775|143040448|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.358|TWO_SIDED|95.0|-0.085|0.237|||ANCOVA|||||0.237|-0.085|0.358
71770340|NCT03050775|143040449|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.823|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||\~30 minutes post-induction||0.2|-0.3|0.823
71770341|NCT03050775|143040449|SUPERIORITY||Median Difference (Final Values)|0.0||||0.853|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||\~60 minutes post-induction. Data was obtained from 33 subjects in the treatment group.||0.3|-0.2|0.853
71770342|NCT03050775|143040449|SUPERIORITY||Median Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||\~120 minutes post-induction||0.2|-0.2|0.986
71770343|NCT03050775|143040450|SUPERIORITY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.5|5.9|||Fisher Exact|||Post-operative shivering observed||5.9|0.5|0.540
71770344|NCT03050775|143040451|SUPERIORITY||Median Difference (Final Values)|0.0||||0.672|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.672
71770345|NCT03050775|143040452|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.571|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||Data was obtained from 32 subjects in the treatment group.||0.1|-0.2|0.571
71770346|NCT03050775|143040453|SUPERIORITY||Odds Ratio (OR)|1.4||||0.619|TWO_SIDED|95.0|0.5|3.7|||Fisher Exact|||||3.7|0.5|0.619
71770347|NCT03050775|143040454|SUPERIORITY||Median Difference (Final Values)|75.0||||0.404|TWO_SIDED|95.0|-100.0|250.0|||Wilcoxon (Mann-Whitney)|||||250|-100|0.404
71770348|NCT03274999|143040458|SUPERIORITY|||||||0.156||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.156
71770349|NCT03274999|143040458|SUPERIORITY|||||||0.395||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.395
71770350|NCT03274999|143040458|SUPERIORITY|||||||0.114||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.114
71770351|NCT03274999|143040458|SUPERIORITY|||||||0.211||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.211
71770352|NCT03274999|143040458|SUPERIORITY|||||||0.332||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.332
71770353|NCT03274999|143040458|SUPERIORITY|||||||0.318||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
71770354|NCT03274999|143040458|SUPERIORITY|||||||0.375||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.375
71770355|NCT03274999|143040458|SUPERIORITY|||||||0.352||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.352
71770356|NCT03274999|143040458|SUPERIORITY|||||||0.312||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.312
71770357|NCT03274999|143040458|SUPERIORITY|||||||0.134||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.134
71770358|NCT03274999|143040458|SUPERIORITY|||||||0.315||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.315
71770359|NCT03274999|143040458|SUPERIORITY|||||||0.071||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.071
71770360|NCT03274999|143040458|SUPERIORITY|||||||0.26||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.260
71770361|NCT03274999|143040458|SUPERIORITY|||||||0.264||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.264
71770362|NCT03274999|143040458|SUPERIORITY|||||||0.381||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.381
71770363|NCT03274999|143040458|SUPERIORITY|||||||0.249||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.249
71770364|NCT03274999|143040458|SUPERIORITY|||||||0.451||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.451
71770365|NCT03274999|143040458|SUPERIORITY|||||||0.393||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.393
71770366|NCT03274999|143040459|SUPERIORITY|||||||0.006||||||Eye-opening, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.006
71770367|NCT03274999|143040459|SUPERIORITY|||||||0.063||||||Eye-opening, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.063
71770368|NCT03274999|143040459|SUPERIORITY|||||||0.005||||||Eye-opening, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.005
71770369|NCT03274999|143040459|SUPERIORITY|||||||0.089||||||Eye-opening, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.089
71770370|NCT03274999|143040459|SUPERIORITY|||||||0.112||||||Eye-opening, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.112
71770371|NCT03274999|143040459|SUPERIORITY|||||||0.16||||||Eye-opening, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.16
71770372|NCT03274999|143040459|SUPERIORITY|||||||0.077||||||Eye-opening, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.077
71770373|NCT03274999|143040459|SUPERIORITY|||||||0.157||||||Eye-opening, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.157
71770374|NCT03274999|143040459|SUPERIORITY|||||||0.111||||||Eye-opening, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.111
71770375|NCT03274999|143040459|SUPERIORITY|||||||0.04||||||Pre-blink, T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.040
71770376|NCT03274999|143040459|SUPERIORITY|||||||0.241||||||Pre-blink, T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.241
71770377|NCT03274999|143040459|SUPERIORITY|||||||0.284||||||Pre-blink, T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.284
71725325|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.09||||0.483|TWO_SIDED|95.0|-0.16|0.34|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-0.16|0.483
71657771|NCT02504671|142831745|OTHER||Difference|51.4|||||TWO_SIDED|95.0|37.3|70.9|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||70.9|37.3|
71725326|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.991|TWO_SIDED|95.0|-0.25|0.25|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.25|0.991
71725327|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.228|TWO_SIDED|95.0|-0.1|0.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-0.10|0.228
71725328|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48|||<|0.001|TWO_SIDED|95.0|1.1|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.85|1.10|<0.001
71725329|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.69|0.94|<0.001
71725330|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53|||<|0.001|TWO_SIDED|95.0|1.15|1.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.90|1.15|<0.001
71725331|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.4|||<|0.001|TWO_SIDED|95.0|1.03|1.78|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|1.03|<0.001
71725332|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.587|TWO_SIDED|95.0|-0.19|0.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.33|-0.19|0.587
71725333|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09||||0.517|TWO_SIDED|95.0|-0.35|0.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.35|0.517
71725334|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.12||||0.36|TWO_SIDED|95.0|-0.14|0.38|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.14|0.360
71725335|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.81|1.6|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.60|0.81|<0.001
71725336|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.78|1.57|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.57|0.78|<0.001
71725337|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.76|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.76|0.97|<0.001
71770378|NCT03274999|143040459|SUPERIORITY|||||||0.313||||||Pre-blink, T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.313
71657772|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71725338|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.17|||<|0.001|TWO_SIDED|95.0|0.77|1.56|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.77|<0.001
71725339|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.811|TWO_SIDED|95.0|-0.24|0.31|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.31|-0.24|0.811
71725340|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.977|TWO_SIDED|95.0|-0.27|0.28|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.27|0.977
71725341|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.164|TWO_SIDED|95.0|-0.08|0.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.47|-0.08|0.164
71725342|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03|||<|0.001|TWO_SIDED|95.0|0.63|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.43|0.63|<0.001
71725343|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.4|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.40|0.60|<0.001
71725344|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15|||<|0.001|TWO_SIDED|95.0|0.75|1.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.56|0.75|<0.001
71725345|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06|||<|0.001|TWO_SIDED|95.0|0.66|1.46|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.46|0.66|<0.001
71770379|NCT03274999|143040459|SUPERIORITY|||||||0.433||||||Pre-blink, T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.433
71770380|NCT03274999|143040459|SUPERIORITY|||||||0.406||||||Pre-blink, T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.406
71770381|NCT03274999|143040459|SUPERIORITY|||||||0.318||||||Pre-blink, T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.318
71830463|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.77|1.14||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.77|
71725346|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.846|TWO_SIDED|95.0|-0.31|0.25|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.25|-0.31|0.846
71725347|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.702|TWO_SIDED|95.0|-0.33|0.23|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-0.33|0.702
71725348|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.496|TWO_SIDED|95.0|-0.18|0.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-0.18|0.496
71725349|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.41|1.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.22|0.41|<0.001
71725350|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.4|1.21|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.40|<0.001
71725351|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.26|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.26|0.46|<0.001
71770382|NCT03274999|143040459|SUPERIORITY|||||||0.499||||||Pre-blink, T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.499
71770383|NCT03274999|143040459|SUPERIORITY|||||||0.39||||||Pre-blink, T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.390
71725352|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.52|1.33|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.52|<0.001
71725353|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.441|TWO_SIDED|95.0|-0.39|0.17|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.17|-0.39|0.441
71725354|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.408|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.16|-0.40|0.408
71725355|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.06||||0.652|TWO_SIDED|95.0|-0.35|0.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-0.35|0.652
71725356|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61||||0.003|TWO_SIDED|95.0|0.21|1.02|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|0.21|0.003
71725357|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.007|TWO_SIDED|95.0|0.15|0.95|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.15|0.007
71725358|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
71725359|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.7|||<|0.001|TWO_SIDED|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.29|<0.001
71725360|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.08||||0.567|TWO_SIDED|95.0|-0.36|0.2|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-0.36|0.567
71725361|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.315|TWO_SIDED|95.0|-0.42|0.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-0.42|0.315
71725362|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.0||||0.997|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.28|-0.28|0.997
71725363|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.056|TWO_SIDED|95.0|-0.01|0.77|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.77|-0.01|0.056
71725364|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.047|TWO_SIDED|95.0|0.01|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|0.01|0.047
71725365|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.95|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|0.17|0.005
71725366|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.007|TWO_SIDED|95.0|0.14|0.92|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|0.14|0.007
71725367|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.276|TWO_SIDED|95.0|-0.42|0.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.12|-0.42|0.276
71725368|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.318|TWO_SIDED|95.0|-0.41|0.13|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.41|0.318
71725369|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03||||0.849|TWO_SIDED|95.0|-0.25|0.3|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.30|-0.25|0.849
71725370|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.138|TWO_SIDED|95.0|-0.09|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.09|0.138
71725371|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.111|TWO_SIDED|95.0|-0.07|0.68|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.68|-0.07|0.111
71725372|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.031|TWO_SIDED|95.0|0.04|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.79|0.04|0.031
71725373|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.49||||0.011|TWO_SIDED|95.0|0.11|0.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.87|0.11|0.011
71725374|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.2||||0.135|TWO_SIDED|95.0|-0.47|0.06|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.47|0.135
71725375|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.175|TWO_SIDED|95.0|-0.44|0.08|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.08|-0.44|0.175
71725376|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.59|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.19|-0.34|0.590
71725377|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.15||||0.402|TWO_SIDED|95.0|-0.2|0.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.49|-0.20|0.402
71725378|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.261|TWO_SIDED|95.0|-0.15|0.54|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.54|-0.15|0.261
71725379|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.134|TWO_SIDED|95.0|-0.08|0.61|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.61|-0.08|0.134
71725380|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|0.03|0.031
71725381|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.061|TWO_SIDED|95.0|-0.47|0.01|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-0.47|0.061
71725382|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.138|TWO_SIDED|95.0|-0.42|0.06|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.06|-0.42|0.138
71888098|NCT00428597|143297095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7911||||0.323|TWO_SIDED|95.0|-2.8|8.3||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.3|-2.8|0.3230
71725383|NCT01559259|142966142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.353|TWO_SIDED|95.0|-0.35|0.13|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-0.35|0.353
71725384|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.88||||0.006|TWO_SIDED|95.0|0.25|1.51|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.51|0.25|0.006
71725385|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.69||||0.03|TWO_SIDED|95.0|0.07|1.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|0.07|0.030
71725386|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.81||||0.012|TWO_SIDED|95.0|0.17|1.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|0.17|0.012
71725387|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.237|TWO_SIDED|95.0|-0.25|1.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.01|-0.25|0.237
71725388|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.5||||0.024|TWO_SIDED|95.0|0.07|0.93|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|0.07|0.024
71725389|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.31||||0.15|TWO_SIDED|95.0|-0.11|0.73|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.11|0.150
71725390|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.43||||0.054|TWO_SIDED|95.0|-0.01|0.86|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.01|0.054
71725391|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.89|||<|0.001|TWO_SIDED|95.0|1.92|3.85|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.85|1.92|<0.001
71725392|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.52|||<|0.001|TWO_SIDED|95.0|1.56|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.56|<0.001
71725393|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.51|||<|0.001|TWO_SIDED|95.0|1.54|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.47|1.54|<0.001
71725394|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.76|||<|0.001|TWO_SIDED|95.0|0.79|2.72|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.72|0.79|<0.001
71725395|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.13|||<|0.001|TWO_SIDED|95.0|0.47|1.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.79|0.47|<0.001
71725396|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.76||||0.021|TWO_SIDED|95.0|0.11|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.11|0.021
71725397|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.027|TWO_SIDED|95.0|0.09|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|0.09|0.027
71725398|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.75|||<|0.001|TWO_SIDED|95.0|3.65|5.84|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.84|3.65|<0.001
71725399|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.21|||<|0.001|TWO_SIDED|95.0|3.13|5.29|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.29|3.13|<0.001
71725400|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.47|||<|0.001|TWO_SIDED|95.0|3.37|5.56|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.56|3.37|<0.001
71725401|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.92|||<|0.001|TWO_SIDED|95.0|2.83|5.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.02|2.83|<0.001
71725402|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.58|0.08|0.031
71725403|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.442|TWO_SIDED|95.0|-0.44|1.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.44|0.442
71725404|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.152|TWO_SIDED|95.0|-0.2|1.3|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.20|0.152
71725405|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.62|||<|0.001|TWO_SIDED|95.0|4.52|6.72|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.72|4.52|<0.001
71725406|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.04|||<|0.001|TWO_SIDED|95.0|3.96|6.13|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.13|3.96|<0.001
71725407|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.4|||<|0.001|TWO_SIDED|95.0|4.3|6.5|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.30|<0.001
71725408|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.88|||<|0.001|TWO_SIDED|95.0|3.78|5.98|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.98|3.78|<0.001
71725409|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.055|TWO_SIDED|95.0|-0.01|1.49|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.49|-0.01|0.055
71725410|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.666|TWO_SIDED|95.0|-0.57|0.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.90|-0.57|0.666
71725411|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.181|TWO_SIDED|95.0|-0.24|1.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|-0.24|0.181
71725412|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.86|||<|0.001|TWO_SIDED|95.0|4.71|7.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||7.01|4.71|<0.001
71725413|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.43|||<|0.001|TWO_SIDED|95.0|4.29|6.57|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.57|4.29|<0.001
71725414|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.79|||<|0.001|TWO_SIDED|95.0|4.64|6.94|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.94|4.64|<0.001
71725415|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.34|||<|0.001|TWO_SIDED|95.0|4.19|6.5|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.50|4.19|<0.001
71725416|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.2|TWO_SIDED|95.0|-0.27|1.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.31|-0.27|0.200
71725417|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.08||||0.831|TWO_SIDED|95.0|-0.69|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.69|0.831
71725418|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.268|TWO_SIDED|95.0|-0.34|1.24|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|-0.34|0.268
71725419|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.73|||<|0.001|TWO_SIDED|95.0|4.54|6.91|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.91|4.54|<0.001
71725420|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.31|||<|0.001|TWO_SIDED|95.0|4.13|6.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.48|4.13|<0.001
71830464|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.88|||||TWO_SIDED|95.9|0.75|1.03||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.03|0.75|
71888099|NCT00428597|143297096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5113||||0.7113|TWO_SIDED|95.0|-6.5|9.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||9.5|-6.5|0.7113
71725421|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.6|||<|0.001|TWO_SIDED|95.0|4.41|6.78|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.78|4.41|<0.001
71725422|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.35|||<|0.001|TWO_SIDED|95.0|4.17|6.54|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.17|<0.001
71725423|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.367|TWO_SIDED|95.0|-0.44|1.19|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.19|-0.44|0.367
71725424|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.908|TWO_SIDED|95.0|-0.84|0.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.84|0.908
71770384|NCT03274999|143040460|SUPERIORITY|||||||0.053||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.053
71770385|NCT03274999|143040460|SUPERIORITY|||||||0.206||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.206
71770386|NCT03274999|143040460|SUPERIORITY|||||||0.221||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.221
71770387|NCT03274999|143040460|SUPERIORITY|||||||0.126||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.126
71725425|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.553|TWO_SIDED|95.0|-0.57|1.06|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.06|-0.57|0.553
71725426|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.45|||<|0.001|TWO_SIDED|95.0|4.22|6.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.68|4.22|<0.001
71725427|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.1|||<|0.001|TWO_SIDED|95.0|3.88|6.31|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.31|3.88|<0.001
71770388|NCT03274999|143040460|SUPERIORITY|||||||0.124||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.124
71830465|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.93|||||TWO_SIDED|95.9|0.71|1.23||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.71|
71830466|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||TWO_SIDED|95.9|0.81|1.1||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.10|0.81|
71830467|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.89|||||TWO_SIDED|95.9|0.76|1.06||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.06|0.76|
71830468|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.96|||||TWO_SIDED|95.9|0.81|1.15||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.15|0.81|
71830469|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.92|||||TWO_SIDED|95.9|0.74|1.14||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.14|0.74|
71830470|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.0|||||TWO_SIDED|95.9|0.81|1.23||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.23|0.81|
71830471|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.15|||||TWO_SIDED|95.9|0.89|1.48||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||1.48|0.89|
71725428|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.42|||<|0.001|TWO_SIDED|95.0|4.19|6.66|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.66|4.19|<0.001
71888100|NCT00428597|143297097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6672||||0.6487|TWO_SIDED|95.0|-8.9|5.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||5.5|-8.9|0.6487
71888101|NCT00428597|143297098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.6545|TWO_SIDED|95.0|-6.4|10.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||10.1|-6.4|0.6545
71725429|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.17|||<|0.001|TWO_SIDED|95.0|3.94|6.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.40|3.94|<0.001
71725430|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.28||||0.518|TWO_SIDED|95.0|-0.57|1.12|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.12|-0.57|0.518
71725431|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.86|TWO_SIDED|95.0|-0.9|0.75|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.75|-0.90|0.860
71725432|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.25||||0.556|TWO_SIDED|95.0|-0.59|1.1|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|-0.59|0.556
71725433|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.44|||<|0.001|TWO_SIDED|95.0|4.17|6.71|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.71|4.17|<0.001
71725434|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.93|||<|0.001|TWO_SIDED|95.0|3.68|6.19|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.19|3.68|<0.001
71725435|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.27|||<|0.001|TWO_SIDED|95.0|4.0|6.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.54|4.00|<0.001
71725436|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.06|||<|0.001|TWO_SIDED|95.0|3.79|6.34|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.34|3.79|<0.001
71725437|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.38||||0.392|TWO_SIDED|95.0|-0.49|1.25|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.25|-0.49|0.392
71725438|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.762|TWO_SIDED|95.0|-0.98|0.72|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.72|-0.98|0.762
71725439|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.21||||0.638|TWO_SIDED|95.0|-0.66|1.08|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.66|0.638
71725440|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.55|||<|0.001|TWO_SIDED|95.0|3.2|5.9|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.90|3.20|<0.001
71725441|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.45|||<|0.001|TWO_SIDED|95.0|3.11|5.78|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.78|3.11|<0.001
71725442|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.91|||<|0.001|TWO_SIDED|95.0|3.56|6.26|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||6.26|3.56|<0.001
71725443|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.39|||<|0.001|TWO_SIDED|95.0|3.04|5.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.74|3.04|<0.001
71725444|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.741|TWO_SIDED|95.0|-0.77|1.08|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|-0.77|0.741
71725445|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.05||||0.907|TWO_SIDED|95.0|-0.85|0.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.95|-0.85|0.907
71725446|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.51||||0.274|TWO_SIDED|95.0|-0.41|1.44|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.44|-0.41|0.274
71725447|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.77|||<|0.001|TWO_SIDED|95.0|2.4|5.13|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.13|2.40|<0.001
71725448|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.91|||<|0.001|TWO_SIDED|95.0|2.56|5.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.26|2.56|<0.001
71725449|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.12|||<|0.001|TWO_SIDED|95.0|2.75|5.48|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.48|2.75|<0.001
71725450|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.01|||<|0.001|TWO_SIDED|95.0|2.64|5.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.38|2.64|<0.001
71725451|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.607|TWO_SIDED|95.0|-1.18|0.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.69|-1.18|0.607
71725452|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.824|TWO_SIDED|95.0|-1.02|0.81|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.02|0.824
71725453|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.827|TWO_SIDED|95.0|-0.83|1.04|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.04|-0.83|0.827
71725454|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.98|||<|0.001|TWO_SIDED|95.0|1.58|4.39|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.39|1.58|<0.001
71725455|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.27|||<|0.001|TWO_SIDED|95.0|1.88|4.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.65|1.88|<0.001
71725456|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.12|||<|0.001|TWO_SIDED|95.0|1.71|4.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.52|1.71|<0.001
71725457|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.57|||<|0.001|TWO_SIDED|95.0|2.16|4.98|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|2.16|<0.001
71725458|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.59||||0.232|TWO_SIDED|95.0|-1.55|0.38|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.55|0.232
71725459|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.31||||0.522|TWO_SIDED|95.0|-1.24|0.63|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-1.24|0.522
71770389|NCT03274999|143040460|SUPERIORITY|||||||0.167||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.167
71770390|NCT03274999|143040460|SUPERIORITY|||||||0.377||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.377
71770391|NCT03274999|143040460|SUPERIORITY|||||||0.397||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.397
71770392|NCT03274999|143040460|SUPERIORITY|||||||0.441||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.441
71770393|NCT03274999|143040461|SUPERIORITY|||||||0.034||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.034
71725460|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.45||||0.356|TWO_SIDED|95.0|-1.41|0.51|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.51|-1.41|0.356
71725461|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.31||||0.001|TWO_SIDED|95.0|0.92|3.69|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.69|0.92|0.001
71725462|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.45|||<|0.001|TWO_SIDED|95.0|1.08|3.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.82|1.08|<0.001
71725463|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.31|4.08|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.08|1.31|<0.001
71725464|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.85|||<|0.001|TWO_SIDED|95.0|1.46|4.23|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.23|1.46|<0.001
71725465|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.264|TWO_SIDED|95.0|-1.49|0.41|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.41|-1.49|0.264
71725466|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.4||||0.4|TWO_SIDED|95.0|-1.32|0.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.32|0.400
71888102|NCT00428597|143297099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0035||||0.1936|TWO_SIDED|95.0|-10.0|2.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||2|-10|0.1936
71888103|NCT00428597|143297100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3801|||<|0.0001|TWO_SIDED|95.0|14.3|28.4||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||28.4|14.3|<0.0001
71657773|NCT02504671|142831745|OTHER||Difference|32.4|||||TWO_SIDED|95.0|16.2|48.7|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||48.7|16.2|
71725467|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.15||||0.758|TWO_SIDED|95.0|-1.1|0.8|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-1.10|0.758
71725468|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.62||||0.018|TWO_SIDED|95.0|0.27|2.97|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.97|0.27|0.018
71725469|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.88||||0.006|TWO_SIDED|95.0|0.55|3.21|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.21|0.55|0.006
71725470|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.29|||<|0.001|TWO_SIDED|95.0|0.94|3.63|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.63|0.94|<0.001
71725471|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.4|||<|0.001|TWO_SIDED|95.0|1.05|3.75|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.75|1.05|<0.001
71725472|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.097|TWO_SIDED|95.0|-1.7|0.14|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.14|-1.70|0.097
71725473|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.52||||0.254|TWO_SIDED|95.0|-1.42|0.38|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.42|0.254
71725474|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.11||||0.812|TWO_SIDED|95.0|-1.03|0.81|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-1.03|0.812
71725475|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32||||0.045|TWO_SIDED|95.0|0.03|2.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.61|0.03|0.045
71725476|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.015|TWO_SIDED|95.0|0.31|2.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.87|0.31|0.015
71725477|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.73||||0.009|TWO_SIDED|95.0|0.43|3.02|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.02|0.43|0.009
71725478|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.08||||0.002|TWO_SIDED|95.0|0.78|3.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.37|0.78|0.002
71725479|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.76||||0.094|TWO_SIDED|95.0|-1.64|0.13|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.13|-1.64|0.094
71725480|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.49||||0.269|TWO_SIDED|95.0|-1.35|0.38|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.38|-1.35|0.269
71725481|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.437|TWO_SIDED|95.0|-1.23|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-1.23|0.437
71725482|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.218|TWO_SIDED|95.0|-0.44|1.92|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.92|-0.44|0.218
71770394|NCT03274999|143040461|SUPERIORITY|||||||0.143||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.143
71725483|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.046|TWO_SIDED|95.0|0.02|2.35|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.35|0.02|0.046
71770395|NCT03274999|143040461|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
71888104|NCT00428597|143297101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23||||0.1339|TWO_SIDED|95.0|-1.6|12.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||12.1|-1.6|0.1339
71725484|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.03|TWO_SIDED|95.0|0.13|2.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.49|0.13|0.030
71725485|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.75||||0.004|TWO_SIDED|95.0|0.57|2.93|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.93|0.57|0.004
71725486|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.01||||0.014|TWO_SIDED|95.0|-1.82|-0.2|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.20|-1.82|0.014
71725487|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.16|TWO_SIDED|95.0|-1.35|0.22|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.22|-1.35|0.160
71725488|NCT01559259|142966143|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.284|TWO_SIDED|95.0|-1.25|0.37|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.37|-1.25|0.284
71725489|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.62||||0.014|TWO_SIDED|95.0|0.13|1.1|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.10|0.13|0.014
71725490|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.46||||0.066|TWO_SIDED|95.0|-0.03|0.94|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.94|-0.03|0.066
71770396|NCT03274999|143040461|SUPERIORITY|||||||0.25||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.250
71770397|NCT03274999|143040461|SUPERIORITY|||||||0.09||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
71725491|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.004|TWO_SIDED|95.0|0.22|1.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.20|0.22|0.004
71725492|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.3||||0.232|TWO_SIDED|95.0|-0.19|0.78|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.19|0.232
71725493|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.32||||0.067|TWO_SIDED|95.0|-0.02|0.66|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.66|-0.02|0.067
71725494|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.16||||0.354|TWO_SIDED|95.0|-0.18|0.5|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.50|-0.18|0.354
71725495|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.017|TWO_SIDED|95.0|0.08|0.76|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.76|0.08|0.017
71725496|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.15|||<|0.001|TWO_SIDED|95.0|1.45|2.86|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.86|1.45|<0.001
71725497|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.93|||<|0.001|TWO_SIDED|95.0|1.23|2.64|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.64|1.23|<0.001
71725498|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.39|2.8|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.80|1.39|<0.001
71725499|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.32|||<|0.001|TWO_SIDED|95.0|0.61|2.02|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.02|0.61|<0.001
71725500|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83|||<|0.001|TWO_SIDED|95.0|0.34|1.33|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.33|0.34|<0.001
71725501|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.62||||0.014|TWO_SIDED|95.0|0.12|1.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.11|0.12|0.014
71725502|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.27|0.28|0.002
71725503|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.45|||<|0.001|TWO_SIDED|95.0|2.69|4.22|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.22|2.69|<0.001
71770398|NCT03274999|143040461|SUPERIORITY|||||||0.328||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
71770399|NCT03274999|143040461|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
71770400|NCT03274999|143040461|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
71770401|NCT03274999|143040461|SUPERIORITY|||||||0.233||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.233
71770402|NCT03274999|143040462|SUPERIORITY|||||||0.072||||||T0: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T0) between the intranasal (test) and extranasal (control) applications are zero.||||0.072
71770403|NCT03274999|143040462|SUPERIORITY|||||||0.297||||||T15: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T15) between the intranasal (test) and extranasal (control) applications are zero.||||0.297
71657774|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71725504|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.13|||<|0.001|TWO_SIDED|95.0|2.36|3.89|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.89|2.36|<0.001
71725505|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.49|||<|0.001|TWO_SIDED|95.0|2.72|4.26|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.72|<0.001
71725506|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.78|||<|0.001|TWO_SIDED|95.0|2.02|3.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.54|2.02|<0.001
71725507|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.21|0.14|0.014
71770404|NCT03274999|143040462|SUPERIORITY|||||||0.328||||||T30: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T30) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
71770405|NCT03274999|143040462|SUPERIORITY|||||||0.447||||||T60: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T60) between the intranasal (test) and extranasal (control) applications are zero.||||0.447
71770406|NCT03274999|143040462|SUPERIORITY|||||||0.328||||||T120: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T120) between the intranasal (test) and extranasal (control) applications are zero.||||0.328
71770407|NCT03274999|143040462|SUPERIORITY|||||||0.09||||||T180: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T180) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
71770408|NCT03274999|143040462|SUPERIORITY|||||||0.055||||||T240: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T240) between the intranasal (test) and extranasal (control) applications are zero.||||0.055
71770409|NCT03274999|143040462|SUPERIORITY|||||||0.09||||||T300: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T300) between the intranasal (test) and extranasal (control) applications are zero.||||0.090
71770410|NCT03274999|143040462|SUPERIORITY|||||||0.5||||||T360: P-value was calculated using 1-sided paired t-test.|t-test, 1 sided|||The null hypothesis for the outcome measure is the difference in the change from the pre-application value at post-application time (T360) between the intranasal (test) and extranasal (control) applications are zero.||||0.500
71770411|NCT01206387|143040477|SUPERIORITY_OR_OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71770412|NCT01206387|143040478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71770413|NCT01206387|143040479|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71770414|NCT01206387|143040480|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71770415|NCT01206387|143040481|SUPERIORITY_OR_OTHER|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
71770416|NCT00706849|143040482|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 treatment groups.||||<0.001
71770417|NCT00706849|143040484|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71657775|NCT02504671|142831745|OTHER||Difference|21.6|||||TWO_SIDED|95.0|8.4|34.9|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||34.9|8.4|
71770418|NCT00706849|143040486|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71770419|NCT00706849|143040488|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71770420|NCT00706849|143040490|SUPERIORITY_OR_OTHER|||||||0.042||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.042
71770421|NCT00706849|143040492|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
71770422|NCT00706849|143040494|SUPERIORITY_OR_OTHER|||||||0.023||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.023
71770423|NCT00706849|143040496|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||<0.001
71770424|NCT00706849|143040498|SUPERIORITY_OR_OTHER|||||||0.004||||||No adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.004
71770425|NCT00706849|143040500|SUPERIORITY_OR_OTHER|||||||0.207||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)|||||||0.207
71770426|NCT00920907|143040515|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.01|||||TWO_SIDED|90.0|0.916|1.114|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for Cmax were contained within 80% to 125%.||1.114|0.916|
71770427|NCT00920907|143040519|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.032|||||TWO_SIDED|90.0|0.922|1.156|||Least squared linear regression|||Biocomparability of ipilimumab Process C to ipilimumab Process B was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for ipilimumab Cmax were contained within 80% to 125%. Point estimates and 90% CIs were constructed for the ratio of geometric means (Process C/Process B) for ipilimumab Cmax.||1.156|0.922|
71770428|NCT00920907|143040524|SUPERIORITY_OR_OTHER||omnibus conditional F-test|0.4||||0.85||||||Not corrected for multiple testing|F-test|numerator 5 degrees freedom, denominator 782 degrees freedom||Time-by-process interaction. Null hypothesis that the pattern of mean ALC values over time is the same for both processes.||||0.85
71657776|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657777|NCT02504671|142831745|OTHER||Difference|48.6|||||TWO_SIDED|95.0|31.7|65.6|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||65.6|31.7|
71657778|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657779|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
71657780|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657781|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657782|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657783|NCT02504671|142831745|OTHER||Difference|40.5|||||TWO_SIDED|95.0|23.7|57.3|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||57.3|23.7|
71657784|NCT02504671|142831745|OTHER||Difference|13.5|||||TWO_SIDED|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||26.5|0.5|
71657785|NCT02504671|142831745|OTHER||Difference|24.3|||||TWO_SIDED|95.0|9.1|39.6|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||39.6|9.1|
71657786|NCT02504671|142831745|OTHER||Difference|10.8|||||TWO_SIDED|95.0|-1.4|23.0|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||23.0|-1.4|
71770429|NCT00920907|143040524|SUPERIORITY_OR_OTHER||F-statistic|4.35|||<|0.0001|||||||F-test|numerator 10 degrees freedom, denominator 782 degrees freedom||Overall time effect. Null hypothesis of no mean ALC changes over time in either process group (treatment arm).||||<0.0001
71770430|NCT02616601|143040532|EQUIVALENCE|If the 90% confidence interval on the percentage difference between generic fluorouracil cream and Carac (fluorouracil) cream lesion clearance were contained within the interval -0.20 to +0.20, and each of these percentages was greater than and statistically different (p\<0.05) from the vehicle cream percentage, then generic fluorouracil cream and Carac (fluorouracil) cream were considered to be therapeutically equivalent.|Mean Difference (Net)|0.04|||||TWO_SIDED|90.0|-11.03|11.11|||||90% Wald's confidence interval with a continuity correction for the difference (Generic Fluorouracil Cream - Carac \[Fluorouracil\] Cream) in complete clearance rates.|||11.11|-11.03|
71770431|NCT02616601|143040532|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71657787|NCT02504671|142831745|OTHER||Difference|16.2|||||TWO_SIDED|95.0|2.6|29.9|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.|||29.9|2.6|
71657788|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657789|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657790|NCT02504671|142831746|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657791|NCT02504671|142831746|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657792|NCT02504671|142831746|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657793|NCT02504671|142831746|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71657794|NCT02504671|142831746|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71725508|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.35||||0.202|TWO_SIDED|95.0|-0.19|0.88|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.88|-0.19|0.202
71725509|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.71||||0.01|TWO_SIDED|95.0|0.17|1.24|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.24|0.17|0.010
71725510|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.0|||<|0.001|TWO_SIDED|95.0|3.24|4.76|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.76|3.24|<0.001
71888105|NCT00428597|143297102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7816||||0.6138|TWO_SIDED|95.0|-5.1|8.7||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||8.7|-5.1|0.6138
71725511|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.55|||<|0.001|TWO_SIDED|95.0|2.79|4.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.31|2.79|<0.001
71725512|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.03|||<|0.001|TWO_SIDED|95.0|3.27|4.79|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|3.27|<0.001
71725513|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.48|||<|0.001|TWO_SIDED|95.0|2.72|4.24|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.24|2.72|<0.001
71725514|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.52||||0.056|TWO_SIDED|95.0|-0.01|1.05|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.05|-0.01|0.056
71725515|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.07||||0.789|TWO_SIDED|95.0|-0.46|0.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.60|-0.46|0.789
71725516|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.55||||0.042|TWO_SIDED|95.0|0.02|1.08|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.08|0.02|0.042
71770432|NCT02616601|143040532|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71770433|NCT02186301|143040533|OTHER||Kaplan-Meier Median|274.0|||||TWO_SIDED|95.0|109.0||Upper Confidence Limit is not available because it cannot be calculated||||||||109|
71725517|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.17|||<|0.001|TWO_SIDED|95.0|3.37|4.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.98|3.37|<0.001
71725518|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.86|||<|0.001|TWO_SIDED|95.0|3.06|4.66|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.66|3.06|<0.001
71725519|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.34|||<|0.001|TWO_SIDED|95.0|3.54|5.14|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||5.14|3.54|<0.001
71725520|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.09|4.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.69|3.09|<0.001
71725521|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.317|TWO_SIDED|95.0|-0.28|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.85|-0.28|0.317
71725522|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03||||0.922|TWO_SIDED|95.0|-0.59|0.53|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.53|-0.59|0.922
71725523|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.45||||0.112|TWO_SIDED|95.0|-0.11|1.02|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.02|-0.11|0.112
71770434|NCT02186301|143040533|OTHER||Kaplan-Meier Median|207.0|||||TWO_SIDED|95.0|112.0|260.0||||||||260.0|112.0|
71770435|NCT02186301|143040533|OTHER||Kaplan Meier Median|390.0|||||TWO_SIDED|95.0|282.0|499.0||||||||499.0|282.0|
71770436|NCT02186301|143040534|OTHER||Percentage|25.0|||||TWO_SIDED|95.0|8.7|49.1||||||||49.1|8.7|
71770437|NCT02186301|143040534|OTHER||Percentage|40.0|||||TWO_SIDED|95.0|22.7|59.4||||||||59.4|22.7|
71770438|NCT02186301|143040534|OTHER||Percentage|78.0|||||TWO_SIDED|95.0|64.0|88.5||||||||88.5|64.0|
71770439|NCT02186301|143040535|OTHER||Kaplan Meier Median|225.0|||||TWO_SIDED|95.0|113.0||Upper Confidence Limit is not available because it cannot be calculated.||||||||113|
71888106|NCT00428597|143297103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2778||||0.9367|TWO_SIDED|95.0|-6.6|7.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||7.1|-6.6|0.9367
71725524|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.1|||<|0.001|TWO_SIDED|95.0|3.27|4.94|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.94|3.27|<0.001
71725525|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.76|||<|0.001|TWO_SIDED|95.0|2.92|4.59|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.59|2.92|<0.001
71725526|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.15|||<|0.001|TWO_SIDED|95.0|3.32|4.99|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.99|3.32|<0.001
71725527|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|3.05|4.72|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.72|3.05|<0.001
71725528|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.22||||0.464|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.81|-0.37|0.464
71725529|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.13||||0.667|TWO_SIDED|95.0|-0.71|0.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.45|-0.71|0.667
71725530|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.27||||0.368|TWO_SIDED|95.0|-0.32|0.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.32|0.368
71725531|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.94|||<|0.001|TWO_SIDED|95.0|3.08|4.81|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.81|3.08|<0.001
71725532|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.63|||<|0.001|TWO_SIDED|95.0|2.77|4.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.49|2.77|<0.001
71725533|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.06|||<|0.001|TWO_SIDED|95.0|3.19|4.92|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.92|3.19|<0.001
71725534|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.82|4.54|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.54|2.82|<0.001
71725535|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.26||||0.397|TWO_SIDED|95.0|-0.34|0.86|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.86|-0.34|0.397
71725536|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.866|TWO_SIDED|95.0|-0.65|0.55|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.65|0.866
71725537|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.37||||0.226|TWO_SIDED|95.0|-0.23|0.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.97|-0.23|0.226
71725538|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.8|||<|0.001|TWO_SIDED|95.0|2.9|4.7|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.70|2.90|<0.001
71725539|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.47|4.26|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.26|2.47|<0.001
71725540|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.89|||<|0.001|TWO_SIDED|95.0|2.99|4.79|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.79|2.99|<0.001
71725541|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.6|||<|0.001|TWO_SIDED|95.0|2.7|4.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.50|2.70|<0.001
71725542|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.2||||0.536|TWO_SIDED|95.0|-0.43|0.83|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.83|-0.43|0.536
71725543|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.23||||0.467|TWO_SIDED|95.0|-0.86|0.39|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.39|-0.86|0.467
71888107|NCT00428597|143297104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.753||||0.0372|TWO_SIDED|95.0|0.5|15.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||15|0.5|0.0372
71888108|NCT00428597|143297105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1463||||0.6939|TWO_SIDED|95.0|-4.6|6.9||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||6.9|-4.6|0.6939
71888109|NCT00428597|143297106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5128||||0.3711|TWO_SIDED|95.0|-11.2|4.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10||4.2|-11.2|0.3711
71888110|NCT00954109|143297135|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71888111|NCT00954109|143297136|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71770440|NCT02186301|143040535|OTHER||Kaplan Meier Median|195.5|||||TWO_SIDED|95.0|143.0|617.0||||||||617.0|143.0|
71770441|NCT02186301|143040535|OTHER||Kaplan Meier Median|335.0|||||TWO_SIDED|95.0|282.0|480.0||||||||480.0|282.0|
71770442|NCT03560739|143040539|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|Geo-mean ratio|1.03|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of AUCtau||1.25|.8|
71770443|NCT03560739|143040539|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.3131|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion|Criteria 2 for bioequivalence testing of AUCtau||0||
71770444|NCT03560739|143040540|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 1.|geo-mean ratio|1.0|||||TWO_SIDED|90.0|0.8|1.25|||||The confidence interval reported in the Point Estimate section below is the one from the criterion, not the estimated confidence interval.|Criteria 1 for bioequivalence testing of Cmax||1.25|.8|
71770445|NCT03560739|143040540|EQUIVALENCE|For reference-scaled average bioequivalence testing, both criteria have to be met: 1) geo-mean ratio needs to fall in \[0.8, 1.25\]; 2) 95% upper bound of the linearized criterion needs to be \<= 0. This part is regarding criterion 2.|95% upper bound of the linearized criter|-0.2446|||||ONE_SIDED|95.0||0.0|||||The upper limit reported in the Point Estimate section below is the limit on the 95% upper bound from the criterion, not the estimated upper limit of the 95% upper bound of the linearized criterion.|Criteria 2 for bioequivalence testing of Cmax||0||
71770446|NCT04389970|143040548|OTHER|Single group, within subject pre/post change.||||||0.39|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no conclusion of significance can be made.||||.39
71770447|NCT04389970|143040549|OTHER|Single group, within subject pre/post change.||||||0.3|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.3
71770448|NCT04389970|143040550|OTHER|Single group, within subjects pre/post change.||||||0.77|||||||t-test, 2 sided|Paired-sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.77
71770449|NCT04389970|143040551|OTHER|Single group, within subjects pre/post change.||||||0.66|||||||t-test, 2 sided|Paired-samples t-test.||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.66
71770450|NCT04389970|143040552|OTHER|Single group, within subjects pre/post change||||||0.88|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.88
71770451|NCT04389970|143040553|OTHER|Single group, within subjects pre/post change||||||0.03|||||||t-test, 2 sided|Paired-samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.03
71770452|NCT04389970|143040554|OTHER|Single group, within subjects pre/post change.||||||0.06|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.06
71830472|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.71|||||TWO_SIDED|95.9|1.44|2.03||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.||2.03|1.44|
71830473|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.72|1.02||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.02|0.72|
71830474|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.7|1.05||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.05|0.70|
71888112|NCT01445678|143297144|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-4.2|||||TWO_SIDED|95.0|-8.91|0.54||||||||0.54|-8.91|
71888113|NCT01445678|143297145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.52|2.59||||||||2.59|-4.52|
71657795|NCT02504671|142831746|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71725544|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.29||||0.361|TWO_SIDED|95.0|-0.34|0.92|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.92|-0.34|0.361
71725545|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.17|||<|0.001|TWO_SIDED|95.0|2.21|4.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.13|2.21|<0.001
71725546|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.04|3.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.95|2.04|<0.001
71725547|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.51|||<|0.001|TWO_SIDED|95.0|2.55|4.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.47|2.55|<0.001
71888114|NCT01445678|143297146|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.23|0.89||||||||0.89|-7.23|
71888115|NCT01445678|143297147|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-3.4|2.33||||||||2.33|-3.4|
71888116|NCT01445678|143297148|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-9.09|0.94||||||||0.94|-9.09|
71888117|NCT01445678|143297149|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-0.88|2.37||||||||2.37|-0.88|
71888118|NCT02065453|143297176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The data will be analyzed using linear regression, Kolmogorov-Smirnov test, and chi-square analysis.||||<0.001
71888119|NCT05523973|143297188|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71888120|NCT05523973|143297189|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71657796|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657797|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71725548|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.09|4.0|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||4.00|2.09|<0.001
71725549|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.13||||0.704|TWO_SIDED|95.0|-0.54|0.8|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.80|-0.54|0.704
71830475|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.78|1.07||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.07|0.78|
71830476|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.84||||||95.8|0.64|1.11||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.11|0.64|
71830477|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.9|||||TWO_SIDED|95.8|0.76|1.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.06|0.76|
71830478|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.79|||||TWO_SIDED|95.8|0.67|0.93||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||0.93|0.67|
71830479|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||TWO_SIDED|95.8|0.77|1.09||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.09|0.77|
71888121|NCT05523973|143297190|SUPERIORITY|||||||0.09|||||||Sign test|||||||0.09
71888122|NCT05523973|143297191|SUPERIORITY|||||||0.722|||||||Sign test|||||||.722
71888123|NCT05523973|143297192|SUPERIORITY|||||||0.28|||||||Sign test|||||||.28
71888124|NCT05523973|143297193|SUPERIORITY|||||||0.15|||||||Sign test|||||||.15
71888125|NCT05523973|143297194|SUPERIORITY|||||||0.8|||||||Sign test|||||||.8
71888126|NCT05523973|143297195|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
71888127|NCT05523973|143297196|SUPERIORITY|||||||0.92|||||||Sign test|||||||.92
71888128|NCT03521791|143297214|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.133|||||||Chi-squared, Corrected|||||||0.133
71888129|NCT03521791|143297215|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
71888130|NCT03521791|143297216|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.333|||||||Chi-squared, Corrected|||||||0.333
71725550|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.89|TWO_SIDED|95.0|-0.71|0.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.62|-0.71|0.890
71888131|NCT03521791|143297217|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
71888132|NCT03521791|143297218|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.394|||||||Fisher Exact|||||||0.394
71888133|NCT03521791|143297219|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.056|||||||t-test, 2 sided|||||||0.056
71830480|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.01|||||TWO_SIDED|95.8|0.81|1.26||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.26|0.81|
71830481|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.12|||||TWO_SIDED|95.8|0.9|1.38||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.38|0.90|
71725551|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.17|TWO_SIDED|95.0|-0.2|1.14|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.14|-0.20|0.170
71725552|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.72|3.67|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.67|1.72|<0.001
71725553|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.58|||<|0.001|TWO_SIDED|95.0|1.61|3.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.56|1.61|<0.001
71725554|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.01|3.97|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.97|2.01|<0.001
71725555|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.75|||<|0.001|TWO_SIDED|95.0|1.77|3.72|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.72|1.77|<0.001
71725556|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.05||||0.882|TWO_SIDED|95.0|-0.74|0.63|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.63|-0.74|0.882
71725557|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.16||||0.64|TWO_SIDED|95.0|-0.84|0.52|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.84|0.640
71725558|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.482|TWO_SIDED|95.0|-0.44|0.93|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.93|-0.44|0.482
71830482|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..|Adjusted GMCs ratio|1.05|||||TWO_SIDED|95.8|0.81|1.37||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||1.37|0.81|
71725559|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.06|||<|0.001|TWO_SIDED|95.0|1.07|3.06|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.06|1.07|<0.001
71725560|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.17|||<|0.001|TWO_SIDED|95.0|1.17|3.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.16|1.17|<0.001
71725561|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.24|||<|0.001|TWO_SIDED|95.0|1.25|3.24|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.24|1.25|<0.001
71888134|NCT03521791|143297221|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.114|||||||Fisher Exact|||||||0.114
71888135|NCT03521791|143297222|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.117|||||||Chi-squared, Corrected|||||||0.117
71888136|NCT03521791|143297223|NON_INFERIORITY|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.626|||||||Fisher Exact|||||||0.626
71830483|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.9|||||TWO_SIDED|95.8|1.51|2.39||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.39|1.51|
71888137|NCT04024501|143297228|OTHER||Geometric Mean ratio|106.2|||||TWO_SIDED|90.0|91.73|122.96|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 2/Treatment 1||122.96|91.73|
71725562|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.42|||<|0.001|TWO_SIDED|95.0|1.43|3.41|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||3.41|1.43|<0.001
71725563|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.36||||0.314|TWO_SIDED|95.0|-1.05|0.34|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.34|-1.05|0.314
71725564|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.25||||0.469|TWO_SIDED|95.0|-0.95|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.44|-0.95|0.469
71725565|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.616|TWO_SIDED|95.0|-0.87|0.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.52|-0.87|0.616
71725566|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.57||||0.002|TWO_SIDED|95.0|0.57|2.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.57|0.002
71725567|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.54||||0.002|TWO_SIDED|95.0|0.55|2.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.53|0.55|0.002
71725568|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.95|||<|0.001|TWO_SIDED|95.0|0.95|2.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.94|0.95|<0.001
71725569|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.91|||<|0.001|TWO_SIDED|95.0|0.92|2.9|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.90|0.92|<0.001
71725570|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.34||||0.33|TWO_SIDED|95.0|-1.04|0.35|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.35|-1.04|0.330
71725571|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.32|-1.06|0.288
71725572|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.916|TWO_SIDED|95.0|-0.66|0.73|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.73|-0.66|0.916
71830484|NCT01616459|143166039|NON_INFERIORITY_OR_EQUIVALENCE|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|2.32|||||TWO_SIDED|95.8|1.94|2.77||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.||2.77|1.94|
71888138|NCT04024501|143297228|OTHER||Geometric mean ratio|50.02|||||TWO_SIDED|90.0|42.34|59.1|||Mixed Model Analysis|The number of subjects in this analysis: 22||Pairwise comparison: Treatment 3/Treatment 1||59.10|42.34|
71725573|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.01||||0.041|TWO_SIDED|95.0|0.04|1.98|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.98|0.04|0.041
71725574|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.034|TWO_SIDED|95.0|0.08|2.01|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.01|0.08|0.034
71725575|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.59||||0.001|TWO_SIDED|95.0|0.62|2.56|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.56|0.62|0.001
71830485|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.9|-3.89|1.36||||||ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.36|-3.89|
71888139|NCT04024501|143297228|OTHER||Geometric mean ratio|47.1|||||TWO_SIDED|90.0|39.85|55.68|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 2||55.68|39.85|
71657798|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71888140|NCT04024501|143297228|OTHER||Geometric mean ratio|58.4|||||TWO_SIDED|90.0|49.49|68.92|||Mixed Model Analysis|The number of subjects in this analysis: 15||Pairwise comparison: Treatment 3/Treatment 4||68.92|49.49|
71657799|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657800|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657801|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657802|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657803|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657804|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657805|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657806|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657807|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657808|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657809|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657810|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657811|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657812|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657813|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657814|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657815|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657816|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657817|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657818|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71725576|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.48||||0.003|TWO_SIDED|95.0|0.52|2.45|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.45|0.52|0.003
71830486|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.08|||||TWO_SIDED|95.9|-4.94|2.45||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.45|-4.94|
71657819|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71888141|NCT04024501|143297228|OTHER||Geometric mean ratio|85.65|||||TWO_SIDED|90.0|73.78|99.43|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 1||99.43|73.78|
71888142|NCT04024501|143297228|OTHER||Geometric mean ratio|80.65|||||TWO_SIDED|90.0|69.48|93.62|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 4/Treatment 2||93.62|69.48|
71888143|NCT04024501|143297228|OTHER||Geometric mean ratio|89.88|||||TWO_SIDED|90.0|77.61|104.09|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 1||104.09|77.61|
71888144|NCT04024501|143297228|OTHER||Geometric mean ratio|84.64|||||TWO_SIDED|90.0|72.94|98.2|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 2||98.20|72.94|
71888145|NCT04024501|143297228|OTHER||Geometric mean ratio|179.68|||||TWO_SIDED|90.0|151.57|212.99|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 3||212.99|151.57|
71888146|NCT04024501|143297228|OTHER||Geometric mean ratio|104.94|||||TWO_SIDED|90.0|90.18|122.11|||Mixed Model Analysis|The number of subjects in this analysis: 21||Pairwise comparison: Treatment 5/Treatment 4||122.11|90.18|
71888147|NCT04024501|143297229|OTHER||Geometric mean ratio|100.39|||||TWO_SIDED|90.0|84.94|118.65|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||118.65|84.94|
71888148|NCT04024501|143297229|OTHER||Geometric mean ratio|41.26|||||TWO_SIDED|90.0|34.74|49.0|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||49.00|34.74|
71888149|NCT04024501|143297229|OTHER||Geometric mean ratio|41.1|||||TWO_SIDED|90.0|34.61|48.81|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||48.81|34.61|
71725577|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.2|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.20|-1.15|0.171
71725578|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.44||||0.201|TWO_SIDED|95.0|-1.11|0.23|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.23|-1.11|0.201
71725579|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.1||||0.763|TWO_SIDED|95.0|-0.57|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.78|-0.57|0.763
71725580|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.66||||0.175|TWO_SIDED|95.0|-0.3|1.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.61|-0.30|0.175
71725581|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.75||||0.12|TWO_SIDED|95.0|-0.2|1.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.70|-0.20|0.120
71888150|NCT04024501|143297229|OTHER||Geometric mean ratio|53.55|||||TWO_SIDED|90.0|45.09|63.59|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||63.59|45.09|
71888151|NCT04024501|143297229|OTHER||Geometric mean ratio|77.05|||||TWO_SIDED|90.0|65.19|91.06|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||91.06|65.19|
71888152|NCT04024501|143297229|OTHER||Geometric mean ratio|76.75|||||TWO_SIDED|90.0|64.94|90.71|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.71|64.94|
71888153|NCT04024501|143297229|OTHER||Geometric mean ratio|84.23|||||TWO_SIDED|90.0|70.93|100.03|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||100.03|70.93|
71725582|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.19||||0.014|TWO_SIDED|95.0|0.24|2.15|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.15|0.24|0.014
71725583|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.31||||0.007|TWO_SIDED|95.0|0.36|2.26|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||2.26|0.36|0.007
71725584|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.054|TWO_SIDED|95.0|-1.32|0.01|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.01|-1.32|0.054
71725585|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.56||||0.096|TWO_SIDED|95.0|-1.22|0.1|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.10|-1.22|0.096
71888154|NCT04024501|143297229|OTHER||Geometric mean ratio|83.9|||||TWO_SIDED|90.0|70.65|99.64|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||99.64|70.65|
71888155|NCT04024501|143297229|OTHER||Geometric mean ratio|204.16|||||TWO_SIDED|90.0|171.22|243.42|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||243.42|171.22|
71888156|NCT04024501|143297229|OTHER||Geometric mean ratio|109.32|||||TWO_SIDED|90.0|92.06|129.83|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||129.83|92.06|
71888157|NCT04024501|143297230|OTHER||Geometric mean ratio|124.99|||||TWO_SIDED|90.0|101.09|154.54|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 2/Treatment 1||154.54|101.09|
71888158|NCT04024501|143297230|OTHER||Geometric mean ratio|33.77|||||TWO_SIDED|90.0|27.15|42.01|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 1||42.01|27.15|
71725586|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.12||||0.724|TWO_SIDED|95.0|-0.79|0.55|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.55|-0.79|0.724
71725587|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.42||||0.345|TWO_SIDED|95.0|-0.46|1.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.30|-0.46|0.345
71725588|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.54||||0.228|TWO_SIDED|95.0|-0.34|1.41|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.41|-0.34|0.228
71725589|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.9||||0.045|TWO_SIDED|95.0|0.02|1.78|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.78|0.02|0.045
71725590|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.08||||0.016|TWO_SIDED|95.0|0.21|1.96|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||1.96|0.21|0.016
71888159|NCT04024501|143297230|OTHER||Geometric mean ratio|27.02|||||TWO_SIDED|90.0|21.72|33.61|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 2||33.61|21.72|
71888160|NCT04024501|143297230|OTHER||Geometric mean ratio|36.84|||||TWO_SIDED|90.0|29.61|45.82|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 3/Treatment 4||45.82|29.61|
71888161|NCT04024501|143297230|OTHER||Geometric mean ratio|91.69|||||TWO_SIDED|90.0|74.15|113.36|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 1||113.36|74.15|
71888162|NCT04024501|143297230|OTHER||Geometric mean ratio|73.36|||||TWO_SIDED|90.0|59.33|90.7|||Mixed Model Analysis|The number of subjects in this analysis: 25||Pairwise comparison: Treatment 4/Treatment 2||90.70|59.33|
71888163|NCT04024501|143297230|OTHER||Geometric mean ratio|67.62|||||TWO_SIDED|90.0|54.37|84.12|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 1||84.12|54.37|
71888164|NCT04024501|143297230|OTHER||Geometric mean ratio|54.11|||||TWO_SIDED|90.0|43.5|67.3|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 2||67.30|43.50|
71657820|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71725591|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.66||||0.036|TWO_SIDED|95.0|-1.27|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||-0.04|-1.27|0.036
71888165|NCT04024501|143297230|OTHER||Geometric mean ratio|200.23|||||TWO_SIDED|90.0|160.15|250.32|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 3||250.32|160.15|
71725592|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54||||0.081|TWO_SIDED|95.0|-1.15|0.07|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.07|-1.15|0.081
71725593|NCT01559259|142966144|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.||0.43|-0.80|0.556
71725594|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.53|||<|0.001|TWO_SIDED|95.0|2.01|3.05||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.05|2.01|<0.001
71725595|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.23|||<|0.001|TWO_SIDED|95.0|1.72|2.75||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.75|1.72|<0.001
71770453|NCT04389970|143040555|OTHER|Single group, within subjects pre/post change||||||0.04|||||||t-test, 2 sided|Paired samples t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||.04
71770454|NCT04389970|143040556|OTHER|Single group, within subjects analysis.||||||0|||||||t-test, 2 sided|Paired sample t-test||This was a feasibility study and was not powered to detect statistical significance. Significance values are presented but no evaluation of significance can be concluded.||||0
71725596|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56|||<|0.001|TWO_SIDED|95.0|2.04|3.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.08|2.04|<0.001
71725597|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.09|||<|0.001|TWO_SIDED|95.0|1.57|2.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.60|1.57|<0.001
71725598|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.44||||0.016|TWO_SIDED|95.0|0.08|0.81||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.81|0.08|0.016
71725599|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.14||||0.428|TWO_SIDED|95.0|-0.21|0.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.50|-0.21|0.428
71725600|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.47||||0.01|TWO_SIDED|95.0|0.11|0.84||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.84|0.11|0.010
71725601|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.38|||<|0.001|TWO_SIDED|95.0|6.59|10.18||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.18|6.59|<0.001
71725602|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.68|||<|0.001|TWO_SIDED|95.0|5.89|9.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.47|5.89|<0.001
71725603|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.7|||<|0.001|TWO_SIDED|95.0|6.91|10.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.50|6.91|<0.001
71725604|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.65|||<|0.001|TWO_SIDED|95.0|5.86|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.86|<0.001
71725605|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.74||||0.25|TWO_SIDED|95.0|-0.52|1.99||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.99|-0.52|0.250
71725606|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.04||||0.956|TWO_SIDED|95.0|-1.21|1.28||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.28|-1.21|0.956
71725607|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.06||||0.099|TWO_SIDED|95.0|-0.2|2.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.31|-0.20|0.099
71888166|NCT04024501|143297230|OTHER||Geometric mean ratio|73.76|||||TWO_SIDED|90.0|59.3|91.75|||Mixed Model Analysis|The number of subjects in this analysis: 23||Pairwise comparison: Treatment 5/Treatment 4||91.75|59.30|
71888167|NCT04187092|143297244|SUPERIORITY||||||<|0.05|||||||ANCOVA|||The 12-week changes in the KOOS scores, and the 12-week changes in the IKDC scores were analyzed by way of analysis of covariance (ANCOVA). Covariates: Age and sex of the subject, the subject's baseline outcome measure, the subject's baseline IKDC Total score, and the subject's standardized intake date (i.e., i.e., subject's intake date minus the intake date of the first enrolled subject) served as the ANCOVA concomitant adjustment variables||||<0.05
71725608|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.22|||<|0.001|TWO_SIDED|95.0|7.78|12.66||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.66|7.78|<0.001
71657821|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71830487|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.48|||||TWO_SIDED|95.9|-2.82|1.38||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.38|-2.82|
71830488|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.24|||||TWO_SIDED|95.9|-10.65|6.13||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||6.13|-10.65|
71888168|NCT03242954|143297281|SUPERIORITY||Cohen's f square|0.011|STANDARD_ERROR_OF_MEAN|0.208||0.5148|TWO_SIDED|95.0|0.001|0.101|||Regression, Linear|||||0.101|0.001|0.5148
71888169|NCT03242954|143297282|SUPERIORITY||Cohen's f square|0.306|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.169|0.389|||Regression, Linear|||||0.389|0.169|<.0001
71888170|NCT03242954|143297283|SUPERIORITY||Cohen's f square|0.008|STANDARD_ERROR_OF_MEAN|0.213||0.4324|TWO_SIDED|95.0|0.001|0.073|||GEE Linear model|||||0.073|0.001|0.4324
71888171|NCT03242954|143297284|SUPERIORITY||Cohen's f square|0.26|STANDARD_ERROR_OF_MEAN|0.149|<|0.0001|TWO_SIDED|95.0|0.175|0.374|||GEE Linear model|||||0.374|0.175|<.0001
71657822|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71725609|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.49|||<|0.001|TWO_SIDED|95.0|7.06|11.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||11.92|7.06|<0.001
71725610|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.72|||<|0.001|TWO_SIDED|95.0|8.28|13.15||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||13.15|8.28|<0.001
71725611|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|9.63|||<|0.001|TWO_SIDED|95.0|7.19|12.06||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||12.06|7.19|<0.001
71725612|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.6||||0.492|TWO_SIDED|95.0|-1.11|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-1.11|0.492
71725613|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.14||||0.873|TWO_SIDED|95.0|-1.83|1.56||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.56|-1.83|0.873
71725614|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.09||||0.21|TWO_SIDED|95.0|-0.62|2.79||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.79|-0.62|0.210
71725615|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.65|||<|0.001|TWO_SIDED|95.0|8.1|15.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.20|8.10|<0.001
71725616|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|10.94|||<|0.001|TWO_SIDED|95.0|7.4|14.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.48|7.40|<0.001
71725617|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.65|||<|0.001|TWO_SIDED|95.0|9.1|16.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.20|9.10|<0.001
71725618|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.72|||<|0.001|TWO_SIDED|95.0|8.18|15.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.26|8.18|<0.001
71725619|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.957|TWO_SIDED|95.0|-2.55|2.42||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.42|-2.55|0.957
71725620|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.78||||0.534|TWO_SIDED|95.0|-3.25|1.69||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.69|-3.25|0.534
71725621|NCT01559259|142966145|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.93||||0.462|TWO_SIDED|95.0|-1.55|3.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.41|-1.55|0.462
71725622|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.06|||<|0.001|TWO_SIDED|95.0|7.23|10.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.89|7.23|<0.001
71725623|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.14|||<|0.001|TWO_SIDED|95.0|6.33|9.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.95|6.33|<0.001
71725624|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|8.66|||<|0.001|TWO_SIDED|95.0|6.83|10.49||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||10.49|6.83|<0.001
71725625|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|7.61|||<|0.001|TWO_SIDED|95.0|5.78|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.44|5.78|<0.001
71725626|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.45||||0.024|TWO_SIDED|95.0|0.19|2.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.70|0.19|0.024
71725627|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.53||||0.392|TWO_SIDED|95.0|-0.69|1.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.76|-0.69|0.392
71725628|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.05||||0.101|TWO_SIDED|95.0|-0.21|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.30|-0.21|0.101
71725629|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.23|||<|0.001|TWO_SIDED|95.0|23.97|36.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.48|23.97|<0.001
71830489|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.03|||||TWO_SIDED|95.9|-2.39|2.21||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.21|-2.39|
71830490|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.4|||||TWO_SIDED|95.9|-2.36|3.22||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.22|-2.36|
71830491|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.45|||||TWO_SIDED|95.9|-1.51|2.66||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||2.66|-1.51|
71830492|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.0|||||TWO_SIDED|95.9|-4.18|1.7||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||1.70|-4.18|
71830493|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.38|||||TWO_SIDED|95.9|-5.64|-0.52||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||-0.52|-5.64|
71830494|NCT01616459|143166040|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.73|||||TWO_SIDED|95.9|-4.84|10.25||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||10.25|-4.84|
71888172|NCT00925600|143297286|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper bound of the 97.5% one-sided confidence interval, or equivalently upper bound of two-sided 95% confidence interval was less than the pre-specified non-inferiority bound of 10%.|Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|3.4||0.0026|TWO_SIDED|95.0|-6.3|7.2|||Mantel Haenszel|||The primary endpoint was summarized with the point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||7.2|-6.3|0.0026
71888173|NCT00925600|143297287|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-6.4|2.0||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||2.0|-6.4|
71888174|NCT00925600|143297288|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.9|5.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||5.3|-5.9|
71770455|NCT03123185|143040558|OTHER|No hypothesis was tested and no acceptance range was specified.|Geometric mean (gMean) ratio (%)|158.61|STANDARD_ERROR_OF_MEAN|22.4|||TWO_SIDED|90.0|133.679|188.195|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||188.195|133.679|
71770456|NCT03123185|143040559|OTHER|No hypothesis was tested and no acceptance range was specified.|gMean ratio (%)|194.18|STANDARD_ERROR_OF_MEAN|26.4|||TWO_SIDED|90.0|158.912|237.267|||||gMean ratio = 10 mg BI 705564 fed/10 mg BI 705564 fast. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect subjects within sequences will be considered as random, the other effects as fixed."||237.267|158.912|
71770457|NCT03123185|143040560|OTHER||Slope|0.4879|STANDARD_ERROR_OF_MEAN|0.0546|||TWO_SIDED|95.0|0.3767|0.599|||||Based on the estimate for slope parameter, a 2-sided 95% Confidence Interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.5990|0.3767|
71770458|NCT03123185|143040560|OTHER||Slope|0.7553|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|0.5736|0.937|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9370|0.5736|
71770459|NCT03123185|143040561|OTHER||Slope|0.4651|STANDARD_ERROR_OF_MEAN|0.1274|||TWO_SIDED|95.0|0.1935|0.7368|||||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fasted condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.7368|0.1935|
71770460|NCT03123185|143040561|OTHER||Slope|0.6651|STANDARD_ERROR_OF_MEAN|0.1385|||TWO_SIDED|95.0|0.3679|0.9622|||Power model||Based on the estimate for slope parameter, a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope. Perfect dose proportionality would correspond to a slope of 1.|The basic model for the investigation of dose proportionality for fed condition was a power model that describes the functional relationship between the dose and PK endpoints.||0.9622|0.3679|
71770461|NCT03505671|143040567|OTHER|||||||0.61|||||||ANCOVA|||||||0.61
71830495|NCT01616459|143166041|NON_INFERIORITY_OR_EQUIVALENCE|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe, 1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.89|||||TWO_SIDED|95.9|-1.46|3.66||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.||3.66|-1.46|
71830496|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.49|||||TWO_SIDED|95.8|-3.44|2.22||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.22|-3.44|
71888175|NCT00925600|143297289|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-7.6|3.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (\< 3.0 at all sites \[P, C, and NO\] vs. ≥ 3.0 at any of these sites), age group (\< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).||3.3|-7.6|
71770462|NCT03505671|143040567|OTHER||Correlation Coefficient|0.15|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (overall, N=20)|||||
71770463|NCT03505671|143040567|OTHER||Correlation coefficient|0.25|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (intervention, N=9)|||||
71770464|NCT03505671|143040567|OTHER||Correlation coefficient|0.09|||||TWO_SIDED||||||||Correlation between EORTC Sensory Subscale baseline and 12 weeks (Usual Care, N=11)|||||
71770465|NCT03505671|143040568|OTHER|||||||0.91||||||P value for the motor subscale|ANCOVA|||||||0.91
71770466|NCT03505671|143040568|OTHER|||||||0.55||||||P value for autonomic subscale|ANCOVA|||||||0.55
71770467|NCT03505671|143040569|OTHER|||||||0.41||||||P value for baseline numbness or tingling severity data|Fisher Exact|||||||0.41
71770468|NCT03505671|143040569|OTHER|||||||0.22||||||P value for baseline numbness or tingling interference data|Fisher Exact|||||||0.22
71770469|NCT03505671|143040569|OTHER|||||||0.58||||||Week 12 p value for numbness or tingling severity data|Fisher Exact|||||||0.58
71770470|NCT03505671|143040569|OTHER|||||||0.12||||||P value for Week 12 numbness or tingling interference data|Fisher Exact|||||||0.12
71770471|NCT03505671|143040569|OTHER|||||||0.57||||||Week 12 - Baseline p value for numbness or tingling severity data|Fisher Exact|||||||0.57
71770472|NCT03505671|143040569|OTHER|||||||0.55||||||Week 12 - Baseline p value for numbness or tingling interference|Fisher Exact|||||||0.55
71770473|NCT03505671|143040570|OTHER|||||||0.99||||||P value for baseline numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
71770474|NCT03505671|143040570|OTHER|||||||0.99||||||P value for 12 weeks numbness or tingling severity Grade 1-3|Fisher Exact|||||||0.99
71770475|NCT03505671|143040570|OTHER|||||||0.99||||||P value for week 12 - baseline change in numbness or tingling severity|Fisher Exact|||||||0.99
71770476|NCT03505671|143040571|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
71770477|NCT03505671|143040572|OTHER|||||||0.69|||||||t-test, 2 sided|||||||0.69
71770478|NCT03505671|143040573|OTHER|||||||0.46||||||P value for cross sectional area sural data|ANCOVA|||||||0.46
71770479|NCT03505671|143040573|OTHER|||||||0.22||||||P value for cross sectional area for median data|ANCOVA|||||||0.22
71770480|NCT03505671|143040574|OTHER|||||||0.2||||||P value for amplitude - sural data|ANCOVA|||||||0.20
71770481|NCT03505671|143040574|OTHER|||||||0.28||||||P value for amplitude - tibial, ankle|ANCOVA|||||||0.28
71770482|NCT03505671|143040574|OTHER|||||||0.13||||||P value for amplitude tibial, pop fossa|ANCOVA|||||||0.13
71770483|NCT03505671|143040574|OTHER|||||||0.71||||||P value for amplitude median, wrist|ANCOVA|||||||0.71
71770484|NCT03505671|143040574|OTHER|||||||0.46||||||P value for amplitude, median, elbow|ANCOVA|||||||0.46
71770485|NCT03505671|143040575|OTHER|||||||0.81||||||P value for latency sural data|ANCOVA|||||||0.81
71770486|NCT03505671|143040575|OTHER|||||||0.76||||||P value for latency tibial, ankle data|ANCOVA|||||||0.76
71770487|NCT03505671|143040575|OTHER|||||||0.24||||||P value for latency tibial, pop fossa|ANCOVA|||||||0.24
71770488|NCT03505671|143040575|OTHER|||||||0.2||||||P value for latency median wrist data|ANCOVA|||||||0.20
71770489|NCT03505671|143040575|OTHER|||||||0.51||||||P value for latency median elbow data|ANCOVA|||||||0.51
71770490|NCT03505671|143040576|OTHER|||||||0.98||||||P value for velocity sural data|ANCOVA|||||||0.98
71770491|NCT03505671|143040576|OTHER|||||||0.03||||||P value for velocity tibial data|ANCOVA|||||||0.03
71770492|NCT03505671|143040576|OTHER|||||||0.81||||||P value for velocity median data|ANCOVA|||||||0.81
71770493|NCT02038829|143040578|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0126|STANDARD_ERROR_OF_MEAN|0.0225||0.973|TWO_SIDED|95.0|-0.0318|0.0569||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0569|-0.0318|0.9730
71775055|NCT01086423|143050306|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.68|||||TWO_SIDED|95.0|-3.74|1.89||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.||1.89|-3.74|
71775056|NCT01086423|143050306|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-2.7|||||TWO_SIDED|95.0|-6.75|-0.11||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.||-0.11|-6.75|
71775057|NCT01086423|143050306|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group\] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.67|||||TWO_SIDED|95.0|-4.6|3.04||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.||3.04|-4.6|
71775058|NCT02439879|143050375|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||paired t test|||All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM||||< 0.05
71775059|NCT00749515|143050381|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71775060|NCT00749515|143050382|OTHER|||||||0.275|||||||t-test, 2 sided|||||||.275
71775061|NCT00749515|143050383|OTHER|||||||0.178|||||||t-test, 2 sided|||||||.178
71775062|NCT00749515|143050384|OTHER|||||||0.062|||||||t-test, 2 sided|||||||.062
71775063|NCT00749515|143050385|OTHER|||||||0.104|||||||t-test, 2 sided|||||||.104
71775064|NCT00277446|143050400|SUPERIORITY_OR_OTHER||||||<|0.03||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||<0.03
71657823|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657824|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657825|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657826|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657827|NCT02504671|142831746|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657828|NCT02504671|142831746|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657829|NCT02504671|142831746|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657830|NCT02504671|142831746|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657831|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657832|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657833|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-2.5|
71657834|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|68.2|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||68.2|-1.9|
71657835|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657836|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657837|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657838|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657839|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657840|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657841|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657842|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657843|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657844|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657845|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657846|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657847|NCT02504671|142831746|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657848|NCT02504671|142831746|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657849|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657850|NCT02504671|142831746|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657851|NCT02504671|142831746|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657852|NCT02504671|142831746|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657853|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657854|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657855|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657856|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657857|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657858|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657859|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657860|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657861|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657862|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657863|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657864|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657865|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657866|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657867|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657868|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71775065|NCT00277446|143050401|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.02
71657869|NCT02504671|142831747|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657870|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657871|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657872|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657873|NCT02504671|142831747|OTHER||Difference|21.6|||||TWO_SIDED|95.0|0.4|42.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||42.8|0.4|
71657874|NCT02504671|142831747|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71775066|NCT00277446|143050402|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."||||0.88
71770494|NCT02038829|143040578|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0822|STANDARD_ERROR_OF_MEAN|0.0225||0.0014|TWO_SIDED|95.0|0.038|0.1264||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1264|0.0380|0.0014
71775067|NCT01302379|143050438|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED|95.0|-97.5|97.5||No adjustment for multiple comparisons|Mixed Models Analysis|||||97.5|-97.5|<0.05
71775068|NCT00413400|143050460|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANCOVA|||treatment effect (etanercept vs. placebo) using ANCOVA including baseline CRP, age, and race||||0.20
71775069|NCT00413400|143050461|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated for each timepoint and repeated measures ANCOVA controlling for age and race performed||||0.92
71775070|NCT00413400|143050462|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated Measures ANCOVA|||within subject percent changes were calculated for each time point, then repeated measures ANCOVA controlling for age and race performed||||0.02
71775071|NCT00413400|143050463|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||repeated measures ANCOVA|||percent change calculated then repeated measures ANCOVA performed controlling for age and race||||0.02
71775072|NCT00413400|143050464|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.46
71775073|NCT00413400|143050465|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
71775074|NCT00413400|143050466|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
71775075|NCT00413400|143050467|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, race||||0.59
71775076|NCT00413400|143050468|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Repeated measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA controlling for age and race performed||||<0.0001
71775077|NCT00413400|143050469|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Repeated Measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA performed controlling for age and race||||0.08
71775078|NCT00413400|143050470|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANCOVA|||ANCOVA controlling for baseline value, age, and race||||0.55
71775079|NCT00891462|143050472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.086|||<|0.0001|TWO_SIDED|95.0|0.05|0.13|||ANCOVA|||||0.13|0.05|<0.0001
71775080|NCT00891462|143050472|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.124|||<|0.0001|TWO_SIDED|95.0|0.08|0.16|||ANCOVA|||||0.16|0.08|<0.0001
71775081|NCT00257608|143050490|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.708||||0.0006|TWO_SIDED|95.0|0.58|0.864|||Log Rank|||||0.864|0.580|0.0006
71775082|NCT00257608|143050496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.5341|TWO_SIDED|95.0|0.698|1.205|||Log Rank|||||1.205|0.698|0.5341
71775083|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-3.18||||0.14|TWO_SIDED|95.0|-5.93|-0.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.43|-5.93|0.14
71775084|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.79|TWO_SIDED|95.0|-3.75|1.49||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.49|-3.75|0.79
71775085|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-4.79|||<|0.01|TWO_SIDED|95.0|-7.35|-2.24||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-2.24|-7.35|<0.01
71775086|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-3.76||||0.04|TWO_SIDED|95.0|-6.37|-1.15|||Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-1.15|-6.37|0.04
71775087|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-2.04||||0.72|TWO_SIDED|95.0|-5.04|0.95||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.95|-5.04|0.72
71725630|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.93|||<|0.001|TWO_SIDED|95.0|21.74|34.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||34.11|21.74|<0.001
71725631|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.86|||<|0.001|TWO_SIDED|95.0|23.6|36.12||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||36.12|23.60|<0.001
71725632|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|27.59|||<|0.001|TWO_SIDED|95.0|21.33|33.86||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||33.86|21.33|<0.001
71725633|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.63||||0.228|TWO_SIDED|95.0|-1.65|6.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.92|-1.65|0.228
71725634|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33||||0.875|TWO_SIDED|95.0|-3.84|4.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.51|-3.84|0.875
71725635|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.27||||0.299|TWO_SIDED|95.0|-2.02|6.55||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.55|-2.02|0.299
71725636|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|36.98|||<|0.001|TWO_SIDED|95.0|28.48|45.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.47|28.48|<0.001
71725637|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.1|||<|0.001|TWO_SIDED|95.0|26.7|43.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.50|26.70|<0.001
71888176|NCT05512949|143297294|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.7||||0.045|TWO_SIDED|95.0|0.5|1.0||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||1.0|0.5|0.045
71725638|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|37.09|||<|0.001|TWO_SIDED|95.0|28.6|45.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||45.59|28.60|<0.001
71725639|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|35.17|||<|0.001|TWO_SIDED|95.0|26.67|43.68||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||43.68|26.67|<0.001
71725640|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.8||||0.543|TWO_SIDED|95.0|-4.02|7.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.63|-4.02|0.543
71725641|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.979|TWO_SIDED|95.0|-5.75|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-5.75|0.979
71888177|NCT05512949|143297294|NON_INFERIORITY|The ID-dose regimen is considered non-inferior if the lower bound of the confidence interval (original scale) is no less than half that of the standard dose, giving a NI margin of 0.5 (NI= -0.301 log10 scale).|Geometric mean titer ratio (GMTR)|0.4||||0.162|TWO_SIDED|95.0|0.3|0.6||Significance can be considered if P \<0.05. Not adjusted for multiple comparisons.|t-test, 2 sided|Two-sample t-test with unequal variance, noninferiority (NI) margin of 0.5 and two-sided type I error rate of 0.05.||The selection of the noninferiority (NI) margin was based on the pivotal Phase 3 trial by Pittman et al., in 2019 comparing one dose of ACAM2000 and the now licensed 2-dose standard MVA-BN regimen, which provided an estimated relative (peak) immune response of approximately 2-times higher for MVA-BN. An NI margin of 0.5 corresponds to an immune response of the lower-dose MVA-BN at least as high as what would be expected for ACAM2000.||0.6|0.3|0.162
71888178|NCT05512949|143297297|SUPERIORITY|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
71888179|NCT05512949|143297297|SUPERIORITY|||||||0.708|||||||Wilcoxon (Mann-Whitney)|||||||0.708
71888180|NCT04660643|143297304|SUPERIORITY||LS Mean difference|-21.4|||<|0.001|TWO_SIDED|95.0|-22.9|-20.0|||Mixed Models Analysis|||||-20.0|-22.9|<.001
71657875|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657876|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71725642|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.92||||0.517|TWO_SIDED|95.0|-3.9|7.74||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.74|-3.90|0.517
71725643|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.96|||<|0.001|TWO_SIDED|95.0|30.51|55.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||55.41|30.51|<0.001
71725644|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|42.2|||<|0.001|TWO_SIDED|95.0|29.9|54.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||54.51|29.90|<0.001
71725645|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|45.12|||<|0.001|TWO_SIDED|95.0|32.67|57.57||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||57.57|32.67|<0.001
71770495|NCT02038829|143040578|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0644|0.1532||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1532|0.0644|<0.0001
71770496|NCT02038829|143040578|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1375|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.0931|0.1818||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation||0.1818|0.0931|<0.0001
71770497|NCT02038829|143040578|SUPERIORITY|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides \~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1567|STANDARD_ERROR_OF_MEAN|0.0226|<|0.0001|TWO_SIDED|95.0|0.1121|0.2012||P-values were adjusted using Dunnett's method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2012|0.1121|<0.0001
71830497|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.06|||||TWO_SIDED|95.8|-4.03|3.86||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.86|-4.03|
71830498|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.01|||||TWO_SIDED|95.8|-2.37|2.3||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.30|-2.37|
71888181|NCT04660643|143297305|SUPERIORITY||LS Mean difference|-15.9|||<|0.001|TWO_SIDED|95.0|-17.0|-14.9|||Mixed Models Analysis|||||-14.9|-17.0|<.001
71888182|NCT04660643|143297306|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
71725646|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|44.25|||<|0.001|TWO_SIDED|95.0|31.79|56.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||56.71|31.79|<0.001
71888183|NCT04660643|143297307|SUPERIORITY||LS Mean difference|-12.9|||<|0.001|TWO_SIDED|95.0|-14.1|-11.7|||Mixed Models Analysis|||||-11.7|-14.1|<.001
71725647|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.29||||0.767|TWO_SIDED|95.0|-9.82|7.25||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.25|-9.82|0.767
71725648|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.04||||0.629|TWO_SIDED|95.0|-10.36|6.27||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.27|-10.36|0.629
71725649|NCT01559259|142966146|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.87||||0.841|TWO_SIDED|95.0|-7.66|9.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||9.39|-7.66|0.841
71725650|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.97|||<|0.001|TWO_SIDED|95.0|3.22|4.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.73|3.22|<0.001
71725651|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.64|||<|0.001|TWO_SIDED|95.0|2.88|4.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.39|2.88|<0.001
71725652|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|4.07|||<|0.001|TWO_SIDED|95.0|3.32|4.83||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.83|3.32|<0.001
71725653|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|3.39|||<|0.001|TWO_SIDED|95.0|2.64|4.14||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.14|2.64|<0.001
71888184|NCT04660643|143297308|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
71888185|NCT04660643|143297309|SUPERIORITY||LS Mean difference|-8.64|||<|0.001|TWO_SIDED|95.0|-10.14|-7.15|||Mixed Models Analysis|||||-7.15|-10.14|<.001
71888186|NCT04660643|143297310|SUPERIORITY||LS Mean difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.38|-0.28|||Mixed Models Analysis|||||-0.28|-0.38|<.001
71725654|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.58||||0.031|TWO_SIDED|95.0|0.05|1.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.11|0.05|0.031
71830499|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-4.67|||||TWO_SIDED|95.8|-12.94|3.6||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.60|-12.94|
71830500|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.46|||||TWO_SIDED|95.8|-1.93|3.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||3.06|-1.93|
71830501|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.02|||||TWO_SIDED|95.8|-2.72|2.64||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.64|-2.72|
71830502|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.0|||||TWO_SIDED|95.8|-1.94|1.9||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||1.90|-1.94|
71830503|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.5|||||TWO_SIDED|95.8|-3.72|2.52||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.52|-3.72|
71888187|NCT04660643|143297311|SUPERIORITY||LS Mean difference|-31.4|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-37.7|-24.4|||Mixed Models Analysis|||||-24.4|-37.7|<.001
71888188|NCT04660643|143297312|SUPERIORITY||LS Mean difference|-5.54|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-7.76|-3.28|||Mixed Models Analysis|||Total Cholesterol||-3.28|-7.76|<.001
71888189|NCT04660643|143297312|SUPERIORITY||LS Mean difference|-6.57|STANDARD_ERROR_OF_MEAN|1.709|<|0.001|TWO_SIDED|95.0|-9.87|-3.15|||Mixed Models Analysis|||LDL Cholesterol||-3.15|-9.87|<.001
71888190|NCT04660643|143297312|SUPERIORITY||LS Mean difference|3.2|STANDARD_ERROR_OF_MEAN|1.33||0.014|TWO_SIDED|95.0|0.6|5.8|||Mixed Models Analysis|||HDL Cholesterol||5.8|0.6|0.014
71725655|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.24||||0.36|TWO_SIDED|95.0|-0.28|0.77||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||0.77|-0.28|0.360
71725656|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.68||||0.011|TWO_SIDED|95.0|0.15|1.21||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.21|0.15|0.011
71725657|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.14|||<|0.001|TWO_SIDED|95.0|10.54|15.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||15.73|10.54|<0.001
71725658|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|11.94|||<|0.001|TWO_SIDED|95.0|9.35|14.52||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.52|9.35|<0.001
71725659|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|13.54|||<|0.001|TWO_SIDED|95.0|10.95|16.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||16.13|10.95|<0.001
71725660|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|12.04|||<|0.001|TWO_SIDED|95.0|9.45|14.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||14.63|9.45|<0.001
71725661|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.1||||0.235|TWO_SIDED|95.0|-0.72|2.91||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.91|-0.72|0.235
71770498|NCT02038829|143040579|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0526|STANDARD_ERROR_OF_MEAN|0.0184||0.0046|TWO_SIDED|95.0|0.0163|0.0888|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.0888|0.0163|0.0046
71770499|NCT02038829|143040579|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0842|STANDARD_ERROR_OF_MEAN|0.0185|<|0.0001|TWO_SIDED|95.0|0.0478|0.1206|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1206|0.0478|<0.0001
71770500|NCT02038829|143040579|NON_INFERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1255|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.089|0.1621|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.1621|0.0890|<0.0001
71830504|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||TWO_SIDED|95.8|-4.38|2.1||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||2.10|-4.38|
71888191|NCT04660643|143297312|SUPERIORITY||LS Mean difference|-19.7|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-24.0|-15.1|||Mixed Models Analysis|||VLDL Cholesterol||-15.1|-24.0|<.001
71888192|NCT04660643|143297312|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-24.9|-16.0|||Mixed Models Analysis|||Triglycerides||-16|-24.9|<.001
71888193|NCT04660643|143297312|SUPERIORITY||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|3.79||0.008|TWO_SIDED|95.0|-17.9|-3.0|||Mixed Models Analysis|||FFA||-3.0|-17.9|0.008
71888194|NCT04660643|143297313|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-8.1|-4.6|||Mixed Models Analysis|||SBP||-4.6|-8.1|<.001
71725662|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1||||0.91|TWO_SIDED|95.0|-1.91|1.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.70|-1.91|0.910
71725663|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.5||||0.105|TWO_SIDED|95.0|-0.32|3.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.31|-0.32|0.105
71725664|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.05|||<|0.001|TWO_SIDED|95.0|12.49|19.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||19.61|12.49|<0.001
71725665|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|14.88|||<|0.001|TWO_SIDED|95.0|11.33|18.43||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.43|11.33|<0.001
71725666|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|16.76|||<|0.001|TWO_SIDED|95.0|13.2|20.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||20.32|13.20|<0.001
71725667|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|15.23|||<|0.001|TWO_SIDED|95.0|11.68|18.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||18.78|11.68|<0.001
71725668|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.83||||0.514|TWO_SIDED|95.0|-1.66|3.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.32|-1.66|0.514
71725669|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.35||||0.783|TWO_SIDED|95.0|-2.82|2.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.13|-2.82|0.783
71725670|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.227|TWO_SIDED|95.0|-0.96|4.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.02|-0.96|0.227
71725671|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.28|||<|0.001|TWO_SIDED|95.0|12.95|23.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.61|12.95|<0.001
71725672|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|17.3|||<|0.001|TWO_SIDED|95.0|11.99|22.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||22.61|11.99|<0.001
71770501|NCT02038829|143040579|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1963|STANDARD_ERROR_OF_MEAN|0.0184|<|0.0001|TWO_SIDED|95.0|0.1601|0.2325|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2325|0.1601|<0.0001
71888195|NCT04660643|143297313|SUPERIORITY||LS Mean difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.8|-2.4|||Mixed Models Analysis|||DBP||-2.4|-4.8|<.001
71888196|NCT04660643|143297314|SUPERIORITY||LS Mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.7|3.5|||ANCOVA|||||3.5|1.7|<.001
71888197|NCT04660643|143297315|SUPERIORITY||LS Mean difference|9.4|||<|0.001|TWO_SIDED|95.0|6.8|12.0|||ANCOVA|||||12.0|6.8|<0.001
71888198|NCT04660643|143297316|SUPERIORITY||Odds Ratio (OR)|95.91|||<|0.001|TWO_SIDED|95.0|54.72|168.09|||Regression, Logistic|||||168.09|54.72|<0.001
71770502|NCT02038829|143040579|SUPERIORITY|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides \~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1902|STANDARD_ERROR_OF_MEAN|0.0186|<|0.0001|TWO_SIDED|95.0|0.1537|0.2268|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.||0.2268|0.1537|<0.0001
71770503|NCT02360605|143040592|SUPERIORITY|||||||0.61||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||FIT completion rates were defined as the percentage of FIT tests returned. Screening ratios were defined as the PC to AC ratio of FIT completion rates. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. Multivariate analyses adjusting for age, race, gender, and literacy level were done using generalized linear models. A test for interaction between literacy level and study arm were assessed.||||0.61
71770504|NCT02360605|143040593|SUPERIORITY|||||||0.3||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.30
71770505|NCT02360605|143040594|SUPERIORITY|||||||0.97||||||p-values control for age (in years), race (African American vs Caucasian and Hispanic), gender, and literacy (2 categories) The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Multivariate analyses adjusting for age, race, gender, and health literacy level were done using generalized linear models. A test for interaction between study arm and each of literacy level, age, gender and race was performed to determine whether treatment effect differed by levels of these factors. An unadjusted test for the main effect of each of health literacy level, age, gender, race and study arm was performed to determine whether screening rates differed by levels of these factors.||||0.97
71770506|NCT01277081|143040607|SUPERIORITY_OR_OTHER||Adjusted Mean difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.58|0.86|||Repeated Measure Analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment|Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.||0.86|0.58|<0.0001
71830505|NCT01616459|143166042|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.5|||||TWO_SIDED|95.8|-5.07|10.06||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.||10.06|-5.07|
71830506|NCT01616459|143166043|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|11.22|||||TWO_SIDED|95.8|7.22|16.49||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||16.49|7.22|
71725673|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|20.45|||<|0.001|TWO_SIDED|95.0|15.13|25.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.78|15.13|<0.001
71725674|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|18.92|||<|0.001|TWO_SIDED|95.0|13.61|24.24||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.24|13.61|<0.001
71725675|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.64||||0.736|TWO_SIDED|95.0|-4.37|3.09||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.09|-4.37|0.736
71770507|NCT01277081|143040608|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.||0.72|0.44|<0.0001
71770508|NCT01277081|143040609|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.65|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.||0.65|0.36|<0.0001
71830507|NCT01616459|143166043|NON_INFERIORITY_OR_EQUIVALENCE|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions \[Newcombe,1998\]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|3.75|||||TWO_SIDED|95.8|1.03|7.57||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.||7.57|1.03|
71830508|NCT00304031|143166071|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.63|TWO_SIDED|95.0|0.88|1.2||One-sided|Log Rank||Reference level = Conventional adjuvant TMZ|This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): Median survival time (MST) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).||1.20|0.88|0.63
71830509|NCT00304031|143166072|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.06|TWO_SIDED|95.0|0.75|1.0||Two-side significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|||1.00|0.75|0.06
71830510|NCT00304031|143166073|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.44|TWO_SIDED|95.0|0.82|1.19||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.19|0.82|0.44
71830511|NCT00304031|143166073|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.86|TWO_SIDED|95.0|0.87|1.62||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.62|0.87|0.86
71830512|NCT00304031|143166074|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.0|0.73|1.05||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Unmethylated MGMT||1.05|0.73|0.15
71830513|NCT00304031|143166074|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.33|TWO_SIDED|95.0|0.66|1.15||One-sided significance level = 0.05|Log Rank||Reference level = Conventional adjuvant TMZ|Methylated MGMT||1.15|0.66|0.33
71830514|NCT00304031|143166075|SUPERIORITY|||||||0.012||||||Two-sided significance level of 0.05|Chi-squared|||||||0.012
71830515|NCT00304031|143166076|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided significance level of 0.05||||||<0.001
71830516|NCT00304031|143166077|SUPERIORITY||||||<|0.001||||||Two-sided test|Log Rank|||||||<0.001
71830517|NCT00304031|143166078|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71830518|NCT00304031|143166079|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71830519|NCT00304031|143166080|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71888199|NCT04660643|143297317|SUPERIORITY||Odds Ratio (OR)|47.27|||<|0.001|TWO_SIDED|95.0|18.32|121.99|||Regression, Logistic|||≥5% body weight reduction from baseline||121.99|18.32|<0.001
71888200|NCT04660643|143297317|SUPERIORITY||Odds Ratio (OR)|71.51|||<|0.001|TWO_SIDED|95.0|34.46|148.39|||Regression, Logistic|||≥10% body weight reduction from baseline||148.39|34.46|<0.001
71830520|NCT00304031|143166081|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
71830521|NCT00304031|143166082|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71830522|NCT00304031|143166083|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
71830523|NCT00304031|143166084|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71830524|NCT00304031|143166085|SUPERIORITY|||||||0.2184|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2184
71830525|NCT00304031|143166085|SUPERIORITY|||||||0.0763|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.||||0.0763
71830526|NCT00304031|143166085|SUPERIORITY|||||||0.5235|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.5235
71830527|NCT00304031|143166086|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
71830528|NCT00304031|143166087|SUPERIORITY|||||||0.03|||||||Z-test of two proportions|||||||0.03
71830529|NCT00304031|143166088|SUPERIORITY|||||||0.0002|||||||Chi-squared|Two-sided test||||||0.0002
71830530|NCT00304031|143166089|SUPERIORITY|||||||0.005|||||||Fisher Exact|Two-sided test||||||0.005
71830531|NCT00304031|143166090|SUPERIORITY|||||||0.018|||||||Fisher Exact|Two-sided test||||||0.018
71888201|NCT04660643|143297317|SUPERIORITY||Odds Ratio (OR)|79.99|||<|0.001|TWO_SIDED|95.0|42.06|152.14|||Regression, Logistic|||≥15% body weight reduction from baseline||152.14|42.06|<0.001
71657877|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657878|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657879|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657880|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657881|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657882|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657883|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657884|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657885|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657886|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657887|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657888|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657889|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657890|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657891|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657892|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657893|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657894|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657895|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657896|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657897|NCT02504671|142831747|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657898|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657899|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657900|NCT02504671|142831747|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657901|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657902|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657903|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71888202|NCT04660643|143297317|SUPERIORITY||Odds Ratio (OR)|140.84|||<|0.001|TWO_SIDED|95.0|66.06|300.29|||Regression, Logistic|||≥20% body weight reduction from baseline||300.29|66.06|<0.001
71770509|NCT01277081|143040610|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment\*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.||0.67|0.38|<0.0001
71770510|NCT00740051|143040613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.86|-0.29||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-0.29|-0.86|<0.0001
71770511|NCT00740051|143040614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.88|-0.32||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.||-0.32|-0.88|<0.0001
71770512|NCT00740051|143040615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5|STANDARD_ERROR_OF_MEAN|5.4||0.0002||95.0|-31.1|-9.9||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo||-9.9|-31.1|0.0002
71770513|NCT00740051|143040616|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.576||||0.0374||95.0|1.057|6.279||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||6.279|1.057|0.0374
71830532|NCT00304031|143166091|SUPERIORITY|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||||||0.1702|||||||Mixed Models Analysis|||A mixed effects model was run with MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.1702
71725676|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62||||0.39|TWO_SIDED|95.0|-5.32|2.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.08|-5.32|0.390
71725677|NCT01559259|142966147|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.53||||0.42|TWO_SIDED|95.0|-2.19|5.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.26|-2.19|0.420
71725678|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.5|||<|0.001|TWO_SIDED|95.0|5.25|7.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.76|5.25|<0.001
71725679|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.87|||<|0.001|TWO_SIDED|95.0|4.62|7.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.11|4.62|<0.001
71725680|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|6.63|||<|0.001|TWO_SIDED|95.0|5.38|7.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||7.88|5.38|<0.001
71725681|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|5.48|||<|0.001|TWO_SIDED|95.0|4.23|6.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||6.73|4.23|<0.001
71770514|NCT00740051|143040617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.285||||0.1281||95.0|0.71|15.196||No adjustment of p-values|Regression, Logistic|||Linagliptin vs. Placebo||15.196|0.710|0.1281
71770515|NCT00740051|143040618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.801||||0.0046||95.0|1.374|5.711||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo||5.711|1.374|0.0046
71770516|NCT02524977|143040627|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
71770517|NCT02106923|143040638|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.98|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.505|105.514|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.514|100.505|<0.0001
71770518|NCT02106923|143040638|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.25|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.809|103.823|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.823|96.809|<0.0001
71830533|NCT00304031|143166091|SUPERIORITY|||||||0.8159|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.8159
71770519|NCT02106923|143040638|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.08|STANDARD_ERROR_OF_MEAN|1.016|<|0.0001|TWO_SIDED|90.0|93.507|98.721|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||98.721|93.507|<0.0001
71725682|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.03||||0.022|TWO_SIDED|95.0|0.15|1.9||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.90|0.15|0.022
71725683|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.39||||0.38|TWO_SIDED|95.0|-0.48|1.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||1.26|-0.48|0.380
71770520|NCT02106923|143040639|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.06||0.0011|TWO_SIDED|90.0|92.3|112.81|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||112.81|92.30|0.0011
71770521|NCT02106923|143040639|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.93|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|95.45|102.53|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.53|95.45|<0.0001
71770522|NCT02106923|143040639|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.7|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|93.59|110.52|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||110.52|93.59|0.0002
71830534|NCT00304031|143166091|SUPERIORITY|||||||0.2174|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10, 12, 22, 24, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT status is reported here.||||0.2174
71830535|NCT00304031|143166092|OTHER|||||||0.023|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. EORTC physical functioning is reported here.||||0.023
71770523|NCT02106923|143040640|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.88|STANDARD_ERROR_OF_MEAN|1.014|<|0.0001|TWO_SIDED|90.0|100.446|105.373|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||105.373|100.446|<0.0001
71770524|NCT02106923|143040640|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.03|STANDARD_ERROR_OF_MEAN|1.021|<|0.0001|TWO_SIDED|90.0|96.448|103.738|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||103.738|96.448|<0.0001
71770525|NCT02106923|143040640|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.49|STANDARD_ERROR_OF_MEAN|1.017|<|0.0001|TWO_SIDED|90.0|93.758|99.311|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||99.311|93.758|<0.0001
71830536|NCT00304031|143166092|OTHER|||||||0.043|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized HVLT-R recognition is reported here.||||0.043
71830537|NCT00304031|143166092|OTHER|||||||0.021|||||||Regression, Cox|||A Cox proportional hazards model was run with overall survival as the outcome of interest and baseline scores as continuous covariates. The final model was determined from stepwise selection. EORTC physical functioning, EORTC role functioning, standardized HVLT-R recognition, standardized HVLT-R recall, and standardized COWA were included in the initial model. Standardized COWA is reported here.||||0.021
71830538|NCT00304031|143166093|SUPERIORITY|||||||0.2357|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.||||0.2357
71830539|NCT00304031|143166093|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.||||0.0147
71830540|NCT00304031|143166093|SUPERIORITY|||||||0.457|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept effects are not shown.)||A mixed effects model was run with NCF Composite Score (baseline, 10, 22, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. MGMT Status is reported here.||||0.457
71888203|NCT04660643|143297318|SUPERIORITY||Hazard Ratio (HR)|0.013|||<|0.001|TWO_SIDED|95.0|0.004|0.046|||Log Rank||Unstratified hazard ratio from Cox proportional hazard model with Baseline Weight (kg), Analysis Country, Sex, IWRS MTD at Week 36, Weight at randomization (kg) as covariates.|||0.046|0.004|<.001
71888204|NCT04660643|143297319|SUPERIORITY||LS Mean difference|-6.4|||<|0.001|TWO_SIDED|95.0|-6.8|-6.0|||Mixed Models Analysis|||||-6.0|-6.8|<.001
71830541|NCT00304031|143166094|SUPERIORITY|||||||0.02|||||||Chi-squared|Two-sided test||||||0.02
71888205|NCT04660643|143297320|SUPERIORITY||LS Mean difference|-17.6|||<|0.001|TWO_SIDED|95.0|-18.8|-16.4|||Mixed Models Analysis|||||-16.4|-18.8|<.001
71830542|NCT00304031|143166095|SUPERIORITY|||||||0.99|||||||Fisher Exact|Two-sided test||||||0.99
71725684|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.15||||0.01|TWO_SIDED|95.0|0.28|2.03||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.03|0.28|0.010
71725685|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|21.52|||<|0.001|TWO_SIDED|95.0|17.17|25.87||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||25.87|17.17|<0.001
71725686|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.62|||<|0.001|TWO_SIDED|95.0|15.29|23.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||23.95|15.29|<0.001
71725687|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|22.24|||<|0.001|TWO_SIDED|95.0|17.89|26.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||26.59|17.89|<0.001
71725688|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|19.69|||<|0.001|TWO_SIDED|95.0|15.35|24.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||24.02|15.35|<0.001
71725689|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|1.83||||0.237|TWO_SIDED|95.0|-1.21|4.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||4.88|-1.21|0.237
71725690|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.07||||0.965|TWO_SIDED|95.0|-3.09|2.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||2.95|-3.09|0.965
71725691|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.56||||0.099|TWO_SIDED|95.0|-0.48|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.60|-0.48|0.099
71725692|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|29.93|||<|0.001|TWO_SIDED|95.0|21.14|38.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||38.73|21.14|<0.001
71725693|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|28.24|||<|0.001|TWO_SIDED|95.0|19.48|37.0||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||37.00|19.48|<0.001
71725694|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|33.1|||<|0.001|TWO_SIDED|95.0|24.31|41.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||41.89|24.31|<0.001
71725695|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|30.64|||<|0.001|TWO_SIDED|95.0|21.87|39.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||39.41|21.87|<0.001
71830543|NCT00304031|143166096|SUPERIORITY|||||||0.33|||||||Fisher Exact|Two-sided test||||||0.33
71830544|NCT02189252|143166142|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|160.05||||0.2702|TWO_SIDED|95.0|64.71|395.82||The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the first test in the fixed testing sequence.||395.82|64.71|0.2702
71888206|NCT04660643|143297321|SUPERIORITY||LS Mean difference|-16.4|||<|0.001|TWO_SIDED|95.0|-17.5|-15.4|||Mixed Models Analysis|||||-15.4|-17.5|<.001
71888207|NCT04660643|143297322|SUPERIORITY||LS Mean difference|-13.6|||<|0.001|TWO_SIDED|95.0|-15.1|-12.2|||Mixed Models Analysis|||||-12.2|-15.1|<.001
71725696|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.71||||0.821|TWO_SIDED|95.0|-6.86|5.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||5.44|-6.86|0.821
71725697|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.4||||0.44|TWO_SIDED|95.0|-8.51|3.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||3.71|-8.51|0.440
71725698|NCT01559259|142966148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.46||||0.432|TWO_SIDED|95.0|-3.69|8.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.||8.61|-3.69|0.432
71725699|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.08||||0.571|TWO_SIDED|95.0|-1.04|3.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||3.20|-1.04|0.571
71725700|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.98||||0.593|TWO_SIDED|95.0|-0.94|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-0.94|0.593
71725701|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.65||||0.282|TWO_SIDED|95.0|-0.39|7.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||7.68|-0.39|0.282
71725702|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.16||||0.552|TWO_SIDED|95.0|-1.11|3.42||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.42|-1.11|0.552
71725703|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.01||||0.994|TWO_SIDED|95.0|-3.13|3.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.11|-3.13|0.994
71725704|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.23||||0.879|TWO_SIDED|95.0|-3.26|2.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.80|-3.26|0.879
71725705|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.33||||0.28|TWO_SIDED|95.0|-1.98|6.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.64|-1.98|0.280
71725706|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|33.67|||<|0.001|TWO_SIDED|95.0|24.54|42.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||42.81|24.54|<0.001
71725707|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.34||||0.003|TWO_SIDED|95.0|14.93|31.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.75|14.93|0.003
71770526|NCT02106923|143040641|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|104.83|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.522|110.412|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||110.412|99.522|<0.0001
71770527|NCT02106923|143040641|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.84|STANDARD_ERROR_OF_MEAN|1.041|<|0.0001|TWO_SIDED|90.0|95.03|109.134|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||109.134|95.030|<0.0001
71770528|NCT02106923|143040641|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.03|STANDARD_ERROR_OF_MEAN|1.037|<|0.0001|TWO_SIDED|90.0|90.217|102.211|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||102.211|90.217|<0.0001
71770529|NCT02106923|143040642|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.94|STANDARD_DEVIATION|1.071||0.0027|TWO_SIDED|90.0|87.925|111.329|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||111.329|87.925|0.0027
71770530|NCT02106923|143040642|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|108.18|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|102.792|113.859|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||113.859|102.792|<0.0001
71830545|NCT02189252|143166142|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|121.61||||0.6367|TWO_SIDED|95.0|49.17|300.76||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the second test in the fixed testing sequence.||300.76|49.17|0.6367
71830546|NCT02189252|143166143|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|193.91||||0.0511|TWO_SIDED|95.0|99.61|377.47||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the third test in the fixed testing sequence.||377.47|99.61|0.0511
71830547|NCT02189252|143166143|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|133.32||||0.3543|TWO_SIDED|95.0|68.49|259.52||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value\>0.05). This is the fourth test in the fixed testing sequence.||259.52|68.49|0.3543
71830548|NCT02189252|143166144|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|259.19||||0.021|TWO_SIDED|95.0|119.75|560.99|||Mixed Models Analysis|||||560.99|119.75|0.0210
71830549|NCT02189252|143166144|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|177.95||||0.1256|TWO_SIDED|95.0|82.22|385.16|||Mixed Models Analysis|||||385.16|82.22|0.1256
71830550|NCT02189252|143166145|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|298.91||||0.0025|TWO_SIDED|95.0|164.32|543.74||The p-value was only interpreted descriptively|Mixed Models Analysis|||||543.74|164.32|0.0025
71830551|NCT02189252|143166145|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|187.28||||0.0418|TWO_SIDED|95.0|102.95|340.66||The p-value was only interpreted descriptively|Mixed Models Analysis|||||340.66|102.95|0.0418
71830552|NCT02189252|143166146|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|79.36||||0.6833|TWO_SIDED|95.0|22.95|274.45|||Mixed Models Analysis|||||274.45|22.95|0.6833
71830553|NCT02189252|143166146|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|69.39||||0.522|TWO_SIDED|95.0|20.07|239.98|||Mixed Models Analysis|||||239.98|20.07|0.5220
71830554|NCT02189252|143166147|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.78||||0.9034|TWO_SIDED|95.0|44.92|244.41|||Mixed Models Analysis|||||244.41|44.92|0.9034
71830555|NCT02189252|143166147|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|80.58||||0.5782||95.0|34.55|187.95|||Mixed Models Analysis|||||187.95|34.55|0.5782
71830556|NCT02189252|143166148|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|753.75||||0.0391|TWO_SIDED|95.0|112.03|5071.6|||Mixed Models Analysis|||||5071.6|112.03|0.0391
71830557|NCT02189252|143166148|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|104.98||||0.9578|TWO_SIDED|95.0|15.6|706.33|||Mixed Models Analysis|||||706.33|15.60|0.9578
71830558|NCT02189252|143166149|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|376.64||||0.0186|TWO_SIDED|95.0|128.55|1103.5|||Mixed Models Analysis|||||1103.5|128.55|0.0186
71830559|NCT02189252|143166149|SUPERIORITY_OR_OTHER||Geometric mean ratio in %|131.74||||0.5955|TWO_SIDED|95.0|44.97|386.0|||Mixed Models Analysis|||||386.00|44.97|0.5955
71830560|NCT01391832|143166155|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 1-month follow-up.|t-value on group differences in change|-1.51|||>|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||>0.05
71830561|NCT01391832|143166155|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 3-month follow-up.|t-value on group differences in change|-2.05|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
71888208|NCT04660643|143297323|SUPERIORITY||LS Mean difference|-8.92|||<|0.001|TWO_SIDED|95.0|-10.4|-7.43|||Mixed Models Analysis|||||-7.43|-10.40|<.001
71888209|NCT04660643|143297324|SUPERIORITY||LS Mean difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.39|-0.29|||Mixed Models Analysis|||||-0.29|-0.39|<.001
71888210|NCT04660643|143297325|SUPERIORITY||LS Mean difference|-34.6|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-40.6|-27.9|||Mixed Models Analysis|||||-27.9|-40.6|<.001
71725708|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|22.28||||0.005|TWO_SIDED|95.0|13.55|31.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.00|13.55|0.005
71725709|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.39||||0.035|TWO_SIDED|95.0|6.28|20.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.50|6.28|0.035
71830562|NCT01391832|143166155|SUPERIORITY|Comparison of differences between rTMS+CPT and sham+CPT groups in change Clinical Administered Post-Traumatic Scale Total Severity Scores from baseline to 6-month follow-up.|t-value on group differences in change|-2.01|||<|0.05|ONE_SIDED|||||Predicted effects on symptom reduction were evaluated with α = 0.05 for one-tailed t-distributions, recommended for designs examining efficacy of therapeutic interventions (Overall, 1991).|Mixed Models Analysis|Restricted maximum likelihood estimators of variance components for fixed effects; Satterthwaite estimates of effective degrees of freedom.|degrees of freedom = 327|Restricted maximum likelihood estimators (ReML) of the variance components were used to compute the maximum likelihood estimators of the fixed effects parameters (i.e., group, time, therapist, all two-way interaction terms, and the three-way interaction term). Thus, we did not exclude participants with missing time points.||||<0.05
71888211|NCT04660643|143297326|SUPERIORITY||LS Mean difference|-7.02|STANDARD_ERROR_OF_MEAN|1.158|<|0.001|TWO_SIDED|95.0|-9.27|-4.72|||Mixed Models Analysis|||Total Cholesterol||-4.72|-9.27|<.001
71725710|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|20.14||||0.001|TWO_SIDED|95.0|8.67|31.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||31.62|8.67|0.001
71888212|NCT04660643|143297326|SUPERIORITY||LS Mean difference|-7.62|STANDARD_ERROR_OF_MEAN|1.707|<|0.001|TWO_SIDED|95.0|-10.91|-4.21|||Mixed Models Analysis|||LDL Cholesterol||-4.21|-10.91|<.001
71888213|NCT04660643|143297326|SUPERIORITY||LS Mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.418||0.064|TWO_SIDED|95.0|-0.14|5.43|||Mixed Models Analysis|||HDL Cholesterol||5.43|-0.14|0.064
71888214|NCT04660643|143297326|SUPERIORITY||LS Mean difference|-20.1|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-24.7|-15.3|||Mixed Models Analysis|||VLDL Cholesterol||-15.3|-24.7|<.001
71888215|NCT04660643|143297326|SUPERIORITY||LS Mean difference|-21.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-25.8|-16.4|||Mixed Models Analysis|||Triglycerides||-16.4|-25.8|<.001
71725711|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.56||||0.088|TWO_SIDED|95.0|-1.39|20.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.51|-1.39|0.088
71725712|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.36||||0.1|TWO_SIDED|95.0|-1.73|20.45||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.45|-1.73|0.100
71888216|NCT04660643|143297326|SUPERIORITY||LS Mean difference|-11.83|STANDARD_ERROR_OF_MEAN|3.793||0.004|TWO_SIDED|95.0|-18.98|-4.06|||Mixed Models Analysis|||FFA||-4.06|-18.98|0.004
71725713|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|62.54|||<|0.001|TWO_SIDED|95.0|50.93|74.15||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.15|50.93|<0.001
71725714|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|51.66|||<|0.001|TWO_SIDED|95.0|39.5|63.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.82|39.50|<0.001
71888217|NCT04660643|143297327|SUPERIORITY||LS Mean difference|-6.9|||<|0.001|TWO_SIDED|95.0|-8.7|-5.1|||Mixed Models Analysis|||SBP||-5.1|-8.7|<.001
71888218|NCT04660643|143297327|SUPERIORITY||LS Mean difference|-3.8|||<|0.001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|||DBP||-2.6|-5.1|<.001
71888219|NCT04660643|143297328|SUPERIORITY||LS Mean difference|2.7|||<|0.001|TWO_SIDED|95.0|1.7|3.7|||ANCOVA|||||3.7|1.7|<.001
71888220|NCT04660643|143297329|SUPERIORITY||LS Mean difference|9.3|||<|0.001|TWO_SIDED|95.0|6.5|12.0|||ANCOVA|||||12.0|6.5|<.001
71888221|NCT03988907|143297330|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.93|1.26||||||||1.26|0.93|
71888222|NCT03988907|143297331|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.20|1.02|
71725715|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.68|||<|0.001|TWO_SIDED|95.0|52.92|76.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.43|52.92|<0.001
71725716|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|52.03|||<|0.001|TWO_SIDED|95.0|40.43|63.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.63|40.43|<0.001
71725717|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.66||||0.138|TWO_SIDED|95.0|-3.04|24.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.35|-3.04|0.138
71725718|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.59||||0.935|TWO_SIDED|95.0|-14.71|13.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.52|-14.71|0.935
71725719|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|13.3||||0.063|TWO_SIDED|95.0|-0.57|27.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.17|-0.57|0.063
71725720|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.68|||<|0.001|TWO_SIDED|95.0|62.82|86.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.53|62.82|<0.001
71725721|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.18|||<|0.001|TWO_SIDED|95.0|50.42|75.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.95|50.42|<0.001
71725722|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.39|||<|0.001|TWO_SIDED|95.0|59.21|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|59.21|<0.001
71725723|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|60.5|||<|0.001|TWO_SIDED|95.0|47.89|73.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.11|47.89|<0.001
71725724|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.43||||0.027|TWO_SIDED|95.0|1.97|26.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.89|1.97|0.027
71770531|NCT02106923|143040642|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.62|STANDARD_ERROR_OF_MEAN|1.071||0.006|TWO_SIDED|90.0|92.116|116.559|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||116.559|92.116|0.0060
71770532|NCT02106923|143040643|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.33|STANDARD_ERROR_OF_MEAN|1.06||0.0008|TWO_SIDED|90.0|89.13|108.47|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)|||108.47|89.13|0.0008
71770533|NCT02106923|143040643|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.71|STANDARD_ERROR_OF_MEAN|1.02|<|0.0001|TWO_SIDED|90.0|94.77|102.8|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)|||102.80|94.77|<0.0001
71770534|NCT02106923|143040643|NON_INFERIORITY_OR_EQUIVALENCE|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.9|STANDARD_ERROR_OF_MEAN|1.06||0.0021|TWO_SIDED|90.0|94.09|114.74|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)|||114.74|94.09|0.0021
71770535|NCT03485495|143040644|SUPERIORITY|||||||0.007||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.007
71830563|NCT01391832|143166156|SUPERIORITY||Mean Difference (Final Values)|-0.666|STANDARD_DEVIATION|0.7101||0.3422|TWO_SIDED|1.422|-0.7548|2.088||It is not adjusted for multiple comparisons.|t-test, 2 sided|degrees of freedom = 58|mean change from baseline to 6-month follow-up, rTMS Active - rTMS Sham|Null hypothesis test of differences in N2 micro-volt change from baseline to 6-month followup.||2.088|-0.7548|.3422
71725725|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.35||||0.729|TWO_SIDED|95.0|-10.91|15.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.61|-10.91|0.729
71725726|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.33||||0.087|TWO_SIDED|95.0|-1.55|24.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.21|-1.55|0.087
71725727|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|75.6|||<|0.001|TWO_SIDED|95.0|62.5|88.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.70|62.50|<0.001
71725728|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.45|||<|0.001|TWO_SIDED|95.0|53.65|81.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.24|53.65|<0.001
71725729|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.46|||<|0.001|TWO_SIDED|95.0|61.21|87.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.70|61.21|<0.001
71725730|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.23|||<|0.001|TWO_SIDED|95.0|50.3|78.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.17|50.30|<0.001
71725731|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|11.59||||0.052|TWO_SIDED|95.0|0.12|23.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.06|0.12|0.052
71725732|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.652|TWO_SIDED|95.0|-9.49|15.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.16|-9.49|0.652
71725733|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.09|TWO_SIDED|95.0|-1.47|22.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||22.03|-1.47|0.090
71725734|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|79.93|||<|0.001|TWO_SIDED|95.0|67.41|92.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||92.46|67.41|<0.001
71725735|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|58.25|85.05||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.05|58.25|<0.001
71725736|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|78.92|||<|0.001|TWO_SIDED|95.0|66.29|91.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.56|66.29|<0.001
71725737|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.56|||<|0.001|TWO_SIDED|95.0|57.04|84.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.07|57.04|<0.001
71725738|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.61||||0.069|TWO_SIDED|95.0|-0.59|19.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.80|-0.59|0.069
71770536|NCT03485495|143040645|SUPERIORITY|||||||0.0272||||||A priori threshold for statistical significance is split evenly between primary and secondary endpoints. α=0.025.|Fisher Exact|||||||0.0272
71830564|NCT01391832|143166156|OTHER|The analysis examined correlations in change in N2 and PTSD symptoms.|Slope|-0.3||||0.02|TWO_SIDED|||||Not adjusted|Regression, Linear|||The analysis examined the association between change in PTSD symptoms from baseline to 6-month follow-up and the change in N2 amplitude to the threatening stimulus from baseline to 6-month follow-up.|Correlations for the individual groups were active rTMS r(28)=-.373 and sham rTMS r(32)=-.296.|||0.02
71725739|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.65||||0.911|TWO_SIDED|95.0|-10.73|12.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.03|-10.73|0.911
71725740|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.27||||0.127|TWO_SIDED|95.0|-2.23|18.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.77|-2.23|0.127
71725741|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.55|||<|0.001|TWO_SIDED|95.0|62.37|90.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.72|62.37|<0.001
71725742|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.6|||<|0.001|TWO_SIDED|95.0|55.93|85.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.28|55.93|<0.001
71770537|NCT03485495|143040646|SUPERIORITY|||||||0.8762|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.8762
71830565|NCT02164240|143166158|OTHER||Clinical Benefit Rate|0.0|||||TWO_SIDED|95.0|0.0|24.7||descriptive statistics only||||Clinical benefit rate of at least 30% at 16 weeks for the entire, combined population, was considered worthy of further study.||24.7|0|
71888223|NCT03988907|143297332|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.16|||||TWO_SIDED|90.0|1.06|1.28||||||||1.28|1.06|
71888224|NCT03988907|143297333|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.12|||||TWO_SIDED|90.0|0.99|1.27||||||||1.27|0.99|
71888225|NCT03988907|143297334|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|1.11|1.3||||||||1.30|1.11|
71725743|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
71770538|NCT03485495|143040647|SUPERIORITY|||||||0.2082|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.2082
71770539|NCT03485495|143040648|SUPERIORITY|||||||0.0038||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-3 data.||||0.0038
71770540|NCT03485495|143040648|SUPERIORITY|||||||0.0018||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO-2 data.||||0.0018
71770541|NCT03485495|143040648|SUPERIORITY|||||||0.46||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to NO data.||||0.46
71770542|NCT03485495|143040649|SUPERIORITY|||||||0.88||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADP-PA data.||||0.88
71770543|NCT03485495|143040649|SUPERIORITY|||||||0.93||||||"The p-value associated with treatment\*visit interaction between Divaza and Placebo treatment groups. Model includes cuff test status, treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to ADR-PA data.||||0.93
71888226|NCT03988907|143297335|OTHER|Descriptive statistics. A sample size of 26 evaluable participants ensures that the two-sided 90% confidence interval for the geometric population mean of the individual exposure ratios of Day 16 to Day 1 will lie within the 0.75 to 1.33 limits of the geometric population mean with at least 80% probability (power).|Ratio of Geometric Least Squares Means|1.27|||||TWO_SIDED|90.0|1.14|1.41||||||||1.41|1.14|
71888227|NCT03932799|143297358|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, coronavirus disease (COVID)-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, and health care utilization during baseline period/acute phase.|Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Robust variance estimates"||0.38|0.16|<.001
71888228|NCT03932799|143297359|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|0.83||||0.43|TWO_SIDED|95.0|0.53|1.31||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||1.31|0.53|.43
71888229|NCT03932799|143297362|SUPERIORITY|Adjusted for workers' compensation-based covariates: age, gender, urban/rural residence, COVID-19 era injury, days from injury to Report of Accident, injury type, injury complexity/severity, days from injury to first opioid prescription, more than 7 days of opioids in acute phase, health care utilization during baseline period/acute phase, and time indicator for each time period (0,1,2).|Odds Ratio (OR)|3.04||||0.002|TWO_SIDED|95.0|1.5|6.14||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Generalized estimating equation|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Outcome modeled longitudinally over the 3 time periods (3-6, 6-9, and 9-12 months)~* Time periods clustered at the individual worker level~* Exchangeable working correlation structure~* Robust variance estimates"||6.14|1.50|.002
71888230|NCT03932799|143297363|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey covariates: days from injury to baseline survey, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and physical therapy (PT) utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, quality of life.|Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.71|1.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.32|0.71|.84
71888231|NCT03932799|143297364|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.03||||0.88|TWO_SIDED|95.0|0.71|1.49||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.49|0.71|.88
71888232|NCT03932799|143297365|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.74||||0.15|TWO_SIDED|95.0|0.49|1.11||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.11|0.49|.15
71888233|NCT03932799|143297366|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.85||||0.38|TWO_SIDED|95.0|0.6|1.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.21|0.60|.38
71725744|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|53.02|83.09||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.09|53.02|<0.001
71725745|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.57||||0.098|TWO_SIDED|95.0|-1.47|18.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.61|-1.47|0.098
71725746|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.721|TWO_SIDED|95.0|-9.02|13.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.04|-9.02|0.721
71770544|NCT02915874|143040652|SUPERIORITY||Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.47||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.02
71888234|NCT03932799|143297367|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.44||||0.12|TWO_SIDED|95.0|0.91|2.28||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Leisure or social activities outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.28|0.91|.12
71888235|NCT03932799|143297367|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.23||||0.42|TWO_SIDED|95.0|0.74|2.07||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Getting out with friends or family outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.07|0.74|.42
71888236|NCT03932799|143297367|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.98||||0.91|TWO_SIDED|95.0|0.63|1.51||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Doing household chores outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.51|0.63|.91
71888237|NCT03932799|143297367|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.19||||0.59|TWO_SIDED|95.0|0.64|2.21||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Using transportation outcome~* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||2.21|0.64|.59
71888238|NCT03932799|143297368|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.24||||0.22|TWO_SIDED|95.0|0.88|1.75||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.75|0.88|.22
71888239|NCT03932799|143297369|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.47||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||3.47|1.12|.02
71888240|NCT03932799|143297370|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|1.32||||0.1|TWO_SIDED|95.0|0.95|1.83||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.83|0.95|.10
71888241|NCT03932799|143297372|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|-0.01||||0.53|TWO_SIDED|95.0|-0.03|0.01||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.01|-0.03|.53
71725747|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.28||||0.115|TWO_SIDED|95.0|-1.85|18.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.41|-1.85|0.115
71770545|NCT02915874|143040653|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.78||0.19|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.19
71725748|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|77.66|||<|0.001|TWO_SIDED|95.0|63.63|91.69||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||91.69|63.63|<0.001
71725749|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.65|||<|0.001|TWO_SIDED|95.0|57.07|86.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.22|57.07|<0.001
71725750|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|76.5|||<|0.001|TWO_SIDED|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||90.79|62.22|<0.001
71725751|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.1|||<|0.001|TWO_SIDED|95.0|54.14|84.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.06|54.14|<0.001
71725752|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.56||||0.086|TWO_SIDED|95.0|-1.15|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.27|-1.15|0.086
71725753|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.01||||0.714|TWO_SIDED|95.0|-8.76|12.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.77|-8.76|0.714
71725754|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.21||||0.164|TWO_SIDED|95.0|-2.8|17.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.22|-2.80|0.164
71725755|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71725756|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.5|||<|0.001|TWO_SIDED|95.0|54.29|84.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.70|54.29|<0.001
71725757|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71770546|NCT02915874|143040654|SUPERIORITY||Slope|2.07|STANDARD_ERROR_OF_MEAN|1.86||0.27|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.27
71770547|NCT02915874|143040655|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|21.3||0.98|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.98
71770548|NCT02915874|143040656|SUPERIORITY||Slope|1.03|STANDARD_ERROR_OF_MEAN|2.58||0.69|TWO_SIDED|||||a priori: 0.05|Mixed Models Analysis|||||||0.69
71770549|NCT02915874|143040657|SUPERIORITY||Slope|-2.77|STANDARD_ERROR_OF_MEAN|4.93||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
71770550|NCT02915874|143040658|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.58||0.08|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis|||||||0.08
71770551|NCT02502006|143040691|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71770552|NCT02502006|143040692|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
71770553|NCT02502006|143040693|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71770554|NCT02502006|143040694|SUPERIORITY|||||||0.2217|||||||ANOVA|||||||0.2217
71770555|NCT02502006|143040695|SUPERIORITY|||||||0.77||||||Adjusted for multiple comparisons|ANOVA|||||||0.77
71770556|NCT02502006|143040695|SUPERIORITY|||||||0.18||||||Adjusted for multiple comparisons|ANOVA|||||||0.18
71770557|NCT02502006|143040696|SUPERIORITY|||||||0.57||||||Adjusted for multiple comparisons|ANOVA|||||||0.57
71770558|NCT02502006|143040696|SUPERIORITY|||||||0.07||||||Adjusted for multiple comparisons|ANOVA|||||||0.07
71770559|NCT02502006|143040697|SUPERIORITY|||||||0.88||||||Adjusted for multiple comparisons|ANOVA|||||||0.88
71770560|NCT02502006|143040697|SUPERIORITY||||||<|0.05||||||Adjusted for multiple comparisons|ANOVA|||||||<0.05
71657904|NCT02504671|142831747|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71725758|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.0|||<|0.001|TWO_SIDED|95.0|51.4|82.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.61|51.40|<0.001
71725759|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|7.46||||0.129|TWO_SIDED|95.0|-2.12|17.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.04|-2.12|0.129
71725760|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.712|TWO_SIDED|95.0|-8.5|12.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.43|-8.50|0.712
71725761|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.12||||0.229|TWO_SIDED|95.0|-3.76|16.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.00|-3.76|0.229
71657905|NCT02504671|142831747|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71725762|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71725763|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|70.54|||<|0.001|TWO_SIDED|95.0|55.45|85.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.64|55.45|<0.001
71725764|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71657906|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 4, Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657907|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657908|NCT02504671|142831748|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71725765|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.05|||<|0.001|TWO_SIDED|95.0|52.53|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.57|52.53|<0.001
71725766|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.38||||0.186|TWO_SIDED|95.0|-3.05|15.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.81|-3.05|0.186
71725767|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.97||||0.703|TWO_SIDED|95.0|-8.18|12.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.12|-8.18|0.703
71725768|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.06||||0.312|TWO_SIDED|95.0|-4.68|14.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.79|-4.68|0.312
71657909|NCT02504671|142831748|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71725769|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71725770|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
71657910|NCT02504671|142831748|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71725771|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71725772|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
71725773|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725774|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71770561|NCT00509262|143040700|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.|Difference in least squares mean|-0.11|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-0.29|0.06|||ANCOVA||Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.|||0.06|-0.29|
71770562|NCT00509262|143040701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8||||0.001|TWO_SIDED|95.0|-17.1|-4.8|||Miettirnen& Nurminen method||Miettirnen \& Nurminen method stratified by renal insufficiency stratum at Visit 4/Week -2 (moderate or severe) \& prior diabetes pharmacotherapy|||-4.8|-17.1|0.001
71830566|NCT01308567|143166206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.7574|TWO_SIDED|95.0|0.819|1.16||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.16|0.819|0.7574
71657911|NCT02504671|142831748|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71725775|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725776|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.38|||<|0.001|TWO_SIDED|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||89.20|59.56|<0.001
71770563|NCT00509262|143040702|SUPERIORITY_OR_OTHER||Difference in least squares mean|7.1|STANDARD_DEVIATION|38.3|||TWO_SIDED|95.0|-1.9|16.1|||ANCOVA||Analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline Fasting Plasma Glucose.|||16.1|-1.9|
71725777|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.59|||<|0.001|TWO_SIDED|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.57|56.61|<0.001
71725778|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.24|||<|0.001|TWO_SIDED|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.30|58.18|<0.001
71725779|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.21|||<|0.001|TWO_SIDED|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||84.56|53.86|<0.001
71725780|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725781|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725782|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71770564|NCT00509262|143040703|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|STANDARD_DEVIATION|3.8|<|0.001|TWO_SIDED|95.0|-2.6|-1.0|||ANCOVA||Analysis of covariance with terms of treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline body weight.|||-1.0|-2.6|<0.001
71770565|NCT00997113|143040717|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.||||0.940
71770566|NCT01037088|143040781|SUPERIORITY||||||>|0.05||||||not significant|Mixed Models Analysis|||Hour 1 after Administration of Cannabis||||>.05
71770567|NCT01037088|143040781|SUPERIORITY||||||=|0.0002|||||||Mixed Models Analysis|||Hour 2 after Administration of Cannabis||||=.0002
71770568|NCT01037088|143040781|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)||||<.0001
71770569|NCT01037088|143040781|SUPERIORITY||||||=|0.0004|||||||Mixed Models Analysis|||Hour 4 after Administration of Cannabis||||=.0004
71770570|NCT01037088|143040781|SUPERIORITY||||||=|0.0018|||||||Mixed Models Analysis|||Hour 5 after Administration of Cannabis||||=.0018
71770571|NCT03036800|143040814|SUPERIORITY||Odds Ratio (OR)|5.19|||<|0.001|TWO_SIDED|95.0|2.09|12.88|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.88|2.09|<0.001
71770572|NCT03036800|143040815|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.45|14.4|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.4|2.45|<0.001
71770573|NCT03036800|143040816|SUPERIORITY||Odds Ratio (OR)|5.04||||0.002|TWO_SIDED|95.0|1.81|14.01|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.01|1.81|0.002
71725783|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725784|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71770574|NCT03036800|143040817|SUPERIORITY||Odds Ratio (OR)|5.24||||0.002|TWO_SIDED|95.0|1.88|14.64|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.64|1.88|0.002
71770575|NCT03036800|143040834|SUPERIORITY||Odds Ratio (OR)|10.12|||<|0.001|TWO_SIDED|95.0|5.26|19.48|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||19.48|5.26|<0.001
71770576|NCT03036800|143040835|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.86|9.36|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||9.36|2.86|<0.001
71770577|NCT03036800|143040836|SUPERIORITY||Odds Ratio (OR)|4.16|||<|0.001|TWO_SIDED|95.0|2.39|7.22|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||7.22|2.39|<0.001
71770578|NCT03036800|143040837|SUPERIORITY||Odds Ratio (OR)|2.44||||0.01|TWO_SIDED|95.0|1.23|4.84|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.84|1.23|0.010
71770579|NCT03036800|143040838|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.14|12.39|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.39|2.14|<0.001
71770580|NCT03036800|143040839|SUPERIORITY||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.32|12.86|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||12.86|3.32|<0.001
71770581|NCT03036800|143040840|SUPERIORITY||Odds Ratio (OR)|8.08|||<|0.001|TWO_SIDED|95.0|3.8|17.16|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 52 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||17.16|3.80|<0.001
71770582|NCT03036800|143040841|SUPERIORITY||Odds Ratio (OR)|2.28||||0.065|TWO_SIDED|95.0|0.95|5.47|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||5.47|0.95|0.065
71770583|NCT03036800|143040842|SUPERIORITY||Odds Ratio (OR)|2.84||||0.206|TWO_SIDED|95.0|0.56|14.34|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||14.34|0.56|0.206
71725785|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71770584|NCT03036800|143040843|SUPERIORITY||Odds Ratio (OR)|3.23||||0.023|TWO_SIDED|95.0|1.17|8.9|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥32% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||8.90|1.17|0.023
71830567|NCT01308567|143166206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.009||||0.9967|TWO_SIDED|95.0|0.85|1.197||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.197|0.85|0.9967
71830568|NCT01308567|143166207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.849|1.152|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.152|0.849|
71830569|NCT01308567|143166207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|0.913|1.236|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.236|0.913|
71830570|NCT01308567|143166208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|||||TWO_SIDED|95.0|0.785|1.17|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.17|0.785|
71657912|NCT02504671|142831748|OTHER||Difference|-2.7|||||TWO_SIDED|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||2.5|-7.9|
71830571|NCT01308567|143166208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916|||||TWO_SIDED|95.0|0.75|1.118|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.118|0.75|
71725786|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725787|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725788|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725789|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71770585|NCT03036800|143040844|SUPERIORITY||Odds Ratio (OR)|4.11||||0.07|TWO_SIDED|95.0|0.89|18.93|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||18.93|0.89|0.070
71770586|NCT03036800|143040845|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
71830572|NCT01308567|143166210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948|||||TWO_SIDED|95.0|0.8|1.123|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.123|0.8|
71830573|NCT01308567|143166210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|||||TWO_SIDED|95.0|0.886|1.238|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.238|0.886|
71830574|NCT01308567|143166212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.986|1.434|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.434|0.986|
71830575|NCT01308567|143166212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.985|1.435|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.435|0.985|
71830576|NCT01308567|143166214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121|||||TWO_SIDED|95.0|0.886|1.417|||||Cabazitaxel 25 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.417|0.886|
71830577|NCT01308567|143166214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.798|1.288|||||Cabazitaxel 20 mg/m\^2 vs Docetaxel 75 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.||1.288|0.798|
71830578|NCT01112670|143166232|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||ANOVA|||||||0.83
71830579|NCT01112670|143166233|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
71830580|NCT01112670|143166234|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||ANOVA|||||||0.90
71830581|NCT01112670|143166235|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||||||0.56
71725790|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71830582|NCT01112670|143166236|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
71830583|NCT01112670|143166237|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||ANOVA|||||||0.86
71830584|NCT01112670|143166238|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANOVA|||||||0.21
71830585|NCT01112670|143166239|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
71830586|NCT01112670|143166240|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||||||0.14
71830587|NCT01112670|143166241|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANOVA|||||||0.29
71725791|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725792|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725793|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725794|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725795|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725796|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725797|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725798|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725799|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725800|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71830588|NCT01112670|143166242|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||ANOVA|||||||0.43
71830589|NCT00779870|143166252|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71657913|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-3.2|19.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||19.4|-3.2|
71725801|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71830590|NCT00779870|143166252|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71830591|NCT01149369|143166255|NON_INFERIORITY_OR_EQUIVALENCE|P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.|Risk Ratio (RR)|1.2||||0.43|TWO_SIDED|95.0|0.8|1.7|||Cochran-Mantel-Haenszel|Stratified by clinic||Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \< 25 mm.||1.7|0.8|0.43
71725802|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725803|NCT01559259|142966149|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725804|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|23.99||||0.003|TWO_SIDED|95.0|13.32|34.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.67|13.32|0.003
71725805|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.83||||0.048|TWO_SIDED|95.0|4.59|25.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.07|4.59|0.048
71725806|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|24.98||||0.005|TWO_SIDED|95.0|13.43|36.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.53|13.43|0.005
71725807|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|16.57||||0.03|TWO_SIDED|95.0|6.25|26.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||26.88|6.25|0.030
71725808|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.86||||0.269|TWO_SIDED|95.0|-4.8|18.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.53|-4.80|0.269
71725809|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.95||||0.735|TWO_SIDED|95.0|-13.34|9.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.43|-13.34|0.735
71725810|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.58||||0.176|TWO_SIDED|95.0|-3.88|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.04|-3.88|0.176
71725811|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|63.3|||<|0.001|TWO_SIDED|95.0|49.07|77.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||77.52|49.07|<0.001
71725812|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|56.81|||<|0.001|TWO_SIDED|95.0|42.28|71.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||71.34|42.28|<0.001
71725813|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.57|||<|0.001|TWO_SIDED|95.0|53.58|81.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.55|53.58|<0.001
71725814|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|53.31|||<|0.001|TWO_SIDED|95.0|38.62|67.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.99|38.62|<0.001
71725815|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|10.28||||0.14|TWO_SIDED|95.0|-3.26|23.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.82|-3.26|0.140
71830592|NCT01149369|143166256|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.5||||0.03|TWO_SIDED|95.0|-2.8|-0.1|||ANCOVA|||||-0.1|-2.8|0.03
71830593|NCT01149369|143166257|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.94|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.94
71657914|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71725816|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.98||||0.674|TWO_SIDED|95.0|-10.94|16.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.89|-10.94|0.674
71725817|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|14.58||||0.034|TWO_SIDED|95.0|1.22|27.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||27.93|1.22|0.034
71725818|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.32|||<|0.001|TWO_SIDED|95.0|58.25|86.39||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.39|58.25|<0.001
71725819|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|67.2|||<|0.001|TWO_SIDED|95.0|52.63|81.78||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.78|52.63|<0.001
71725820|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|72.4|||<|0.001|TWO_SIDED|95.0|58.4|86.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.40|58.40|<0.001
71725821|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|64.12|||<|0.001|TWO_SIDED|95.0|49.32|78.91||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.91|49.32|<0.001
71725822|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.4||||0.119|TWO_SIDED|95.0|-2.06|18.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.85|-2.06|0.119
71725823|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|2.84||||0.616|TWO_SIDED|95.0|-8.3|13.98||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.98|-8.30|0.616
71725824|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|8.34||||0.125|TWO_SIDED|95.0|-2.2|18.87||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.87|-2.20|0.125
71725825|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|74.49|||<|0.001|TWO_SIDED|95.0|60.73|88.25||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||88.25|60.73|<0.001
71725826|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.38|||<|0.001|TWO_SIDED|95.0|55.05|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.71|55.05|<0.001
71725827|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|73.52|||<|0.001|TWO_SIDED|95.0|59.65|87.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||87.38|59.65|<0.001
71725828|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.36|||<|0.001|TWO_SIDED|95.0|54.01|82.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||82.71|54.01|<0.001
71770587|NCT03036800|143040846|SUPERIORITY||Mean Difference (Net)|-4.63|||<|0.001|TWO_SIDED|95.0|-5.85|-3.4|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.4|-5.85|<0.001
71830594|NCT01149369|143166258|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.73
71725829|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|6.33||||0.187|TWO_SIDED|95.0|-2.99|15.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.65|-2.99|0.187
71725830|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.79||||0.881|TWO_SIDED|95.0|-9.42|10.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||10.99|-9.42|0.881
71725831|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.05||||0.311|TWO_SIDED|95.0|-4.6|14.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.71|-4.60|0.311
71725832|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725833|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725834|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725835|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725836|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725837|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725838|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725839|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725840|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725841|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71830595|NCT01149369|143166259|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
71830596|NCT01149369|143166260|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.06|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.06
71725842|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725843|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725844|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725845|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725846|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725847|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725848|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725849|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725850|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71770588|NCT03036800|143040847|SUPERIORITY||Mean Difference (Net)|-5.89|||<|0.001|TWO_SIDED|95.0|-7.76|-4.02|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.02|-7.76|<0.001
71770589|NCT03036800|143040848|SUPERIORITY||Mean Difference (Net)|-6.87|||<|0.001|TWO_SIDED|95.0|-9.03|-4.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.71|-9.03|<0.001
71770590|NCT03036800|143040849|SUPERIORITY||Mean Difference (Net)|-5.44|||<|0.001|TWO_SIDED|95.0|-8.34|-2.53|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute weight change (kg) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.53|-8.34|<0.001
71770591|NCT03036800|143040850|SUPERIORITY||Mean Difference (Net)|-3.72|||<|0.001|TWO_SIDED|95.0|-4.63|-2.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.80|-4.63|<0.001
71657915|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71830597|NCT01149369|143166261|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.24|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.24
71725851|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725852|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725853|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725854|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71770592|NCT03036800|143040851|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.14|-3.25|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.25|-6.14|<0.001
71770593|NCT03036800|143040852|SUPERIORITY||Mean Difference (Net)|-5.37|||<|0.001|TWO_SIDED|95.0|-7.02|-3.71|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-3.71|-7.02|<0.001
71770594|NCT03036800|143040853|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|95.0|-6.42|-1.77|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.77|-6.42|0.001
71830598|NCT01149369|143166262|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.01
71830599|NCT01149369|143166263|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.22
71830600|NCT01149369|143166264|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.03||||0.51|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.51
71830601|NCT01149369|143166265|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.12|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.12
71830602|NCT01149369|143166266|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|0.02
71830603|NCT01149369|143166267|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.17|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||||0.7|-0.1|0.17
71830604|NCT01149369|143166268|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.6||||0.59|TWO_SIDED|95.0|-7.0|12.2|||ANCOVA|||||12.2|-7.0|0.59
71830605|NCT01149369|143166269|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.1||||0.61|TWO_SIDED|95.0|-5.9|10.0|||ANCOVA|||||10.0|-5.9|0.61
71830606|NCT01149369|143166270|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.23|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|||||0.2|-0.1|0.23
71830607|NCT01149369|143166271|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.97|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.97
71657916|NCT02504671|142831748|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71725855|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725856|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71830608|NCT01149369|143166272|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|3.1||||0.77|TWO_SIDED|95.0|-18.0|24.2|||ANCOVA|||||24.2|-18.0|0.77
71830609|NCT01149369|143166273|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.46|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.46
71830610|NCT01149369|143166274|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||||0.4|-0.2|0.44
71830611|NCT01149369|143166275|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.77
71830612|NCT01149369|143166276|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.8|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||||0.5|-0.6|0.80
71830613|NCT01149369|143166277|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.88|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.88
71830614|NCT01149369|143166278|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-10.9||||0.17|TWO_SIDED|95.0|-26.5|4.7|||ANCOVA|||||4.7|-26.5|0.17
71830615|NCT01149369|143166279|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.07|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||0.0|-1.5|0.07
71830616|NCT01149369|143166280|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.53|TWO_SIDED|95.0|-0.7|1.3|||ANCOVA|||||1.3|-0.7|0.53
71830617|NCT01149369|143166281|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.93|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||||1.0|-0.9|0.93
71830618|NCT01149369|143166282|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.52|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||||0.2|-1.0|0.52
71830619|NCT01149369|143166283|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.76|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.1|-0.1|0.76
71830620|NCT01149369|143166284|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.45|TWO_SIDED|95.0|-2.0|0.9|||ANCOVA|||||0.9|-2.0|0.45
71830621|NCT01149369|143166285|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||||0.1|0.0|0.18
71830622|NCT01149369|143166286|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.008|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|||||-0|-0.2|0.008
71830623|NCT01149369|143166287|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||||-0.3|-0.9|0.001
71725857|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725858|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725859|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725860|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725861|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725862|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725863|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71770595|NCT03036800|143040854|SUPERIORITY||Mean Difference (Net)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.5|-1.91|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.91|-3.5|<0.001
71725864|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725865|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725866|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725867|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71770596|NCT03036800|143040855|SUPERIORITY||Mean Difference (Net)|-1.89|||<|0.001|TWO_SIDED|95.0|-2.91|-0.86|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.86|-2.91|<0.001
71770597|NCT03036800|143040856|SUPERIORITY||Mean Difference (Net)|-3.28||||0.01|TWO_SIDED|95.0|-5.77|-0.8|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-0.80|-5.77|0.01
71657917|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71725868|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725869|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725870|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725871|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725872|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71830624|NCT01149369|143166288|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
71830625|NCT01149369|143166289|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.13|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.13
71830626|NCT01149369|143166290|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
71830627|NCT01149369|143166291|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
71830628|NCT01149369|143166292|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.007|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.007
71830629|NCT01149369|143166293|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.005|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||||-0.2|-1.3|0.005
71830630|NCT01149369|143166294|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||||-0.3|-1.1|0.001
71830631|NCT01149369|143166295|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.003|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||||-0.3|-2.3|0.003
71657918|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71830632|NCT01149369|143166296|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.03|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.03
71830633|NCT01149369|143166297|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.16|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.16
71830634|NCT01149369|143166298|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.05
71888242|NCT03932799|143297373|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.16||||0.053|TWO_SIDED|95.0|0.0|0.32||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.32|-0.00|.053
71888243|NCT03932799|143297374|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|beta|0.22||||0.01|TWO_SIDED|95.0|0.05|0.38||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||0.38|0.05|.01
71888244|NCT03932799|143297375|SUPERIORITY|Adjusted for same covariates as primary outcomes, plus survey-based covariates: days from injury to baseline survey date, education, household income, race/ethnicity, working for pay, recovery expectations, anxious symptoms, depressive symptoms, pre-injury opioid, chiropractic and PT utilization during baseline period/acute phase, cannabis for injury pain, alcohol misuse risk, current tobacco use, pain intensity/interference, Functional Comorbidity Index, health status, and quality of life.|Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.42|1.35||"* two-tailed test~* p-values \< 0.05 are statistically significant"|Regression, Logistic|||"* Primary predictor is binary (1 for Washington, 0 for Ohio)~* Models survey weighted~* Robust variance estimates"||1.35|0.42|.35
71888245|NCT01307033|143297398|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|0.2|||||TWO_SIDED|95.0|-1.7|2.2|||Constained logitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||2.2|-1.7|
71888246|NCT01307033|143297399|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-2.3|||||TWO_SIDED|95.0|-5.0|0.5|||Constained longitudinal data analysis|Model included treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups||||0.5|-5.0|
71888247|NCT00947531|143297409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17|||<|0.0001|TWO_SIDED|95.0|-8.22|-4.13||P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).|ANCOVA|The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.||The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation \[SD\] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).||-4.13|-8.22|< 0.0001
71888248|NCT01773421|143297439|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric Least Square (LS) Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.15||||||||1.15|0.97|
71888249|NCT01773421|143297440|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.11|||||TWO_SIDED|90.0|1.02|1.2||||||||1.2|1.02|
71725873|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71888250|NCT01773421|143297441|EQUIVALENCE|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.13|||||TWO_SIDED|90.0|1.0|1.27||||||||1.27|1|
71888251|NCT04656990|143297474|SUPERIORITY||Slope|17.1|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71725874|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71888252|NCT04656990|143297477|SUPERIORITY||Slope|3.4|||=|0.04|TWO_SIDED||||||Mixed Models Analysis|||||||=0.04
71888253|NCT03657459|143297502|SUPERIORITY|||||||0.0096|||||||Chi-squared|Pearsons Chi Square||||||0.0096
71888254|NCT03657459|143297503|SUPERIORITY|||||||0.9||||||no adjustment|Chi-squared|Pearson Chi-square||||||0.90
71888255|NCT00282243|143297510|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.79|||||TWO_SIDED|90.0|85.42|92.29|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||92.29|85.42|
71725875|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725876|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725877|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725878|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725879|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725880|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725881|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725882|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725883|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725884|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725885|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725886|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725887|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71770598|NCT03036800|143040857|SUPERIORITY||Mean Difference (Net)|-5.51||||0.003|TWO_SIDED|95.0|-9.09|-1.94|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-1.94|-9.09|0.003
71725888|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725889|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725890|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725891|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725892|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725893|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725894|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725895|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725896|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725897|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725898|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725899|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725900|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725901|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71725902|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|71.1|||<|0.001|TWO_SIDED|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||86.38|55.82|<0.001
71725903|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|68.31|||<|0.001|TWO_SIDED|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||83.74|52.88|<0.001
71725904|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|69.98|||<|0.001|TWO_SIDED|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||85.48|54.47|<0.001
71725905|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|65.95|||<|0.001|TWO_SIDED|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.74|50.16|<0.001
71725906|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.25||||0.265|TWO_SIDED|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.41|-3.92|0.265
71725907|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.85||||0.71|TWO_SIDED|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.53|-7.82|0.710
71725908|NCT01559259|142966150|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|3.99||||0.416|TWO_SIDED|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.49|-5.52|0.416
71770599|NCT03036800|143040877|SUPERIORITY||Odds Ratio (OR)|10.53|||<|0.001|TWO_SIDED|95.0|3.83|28.97|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥5% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||28.97|3.83|<0.001
71770600|NCT03036800|143040878|SUPERIORITY||Odds Ratio (OR)|23.1|||<|0.001|TWO_SIDED|95.0|7.55|70.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||70.67|7.55|<0.001
71770601|NCT03036800|143040881|SUPERIORITY||Odds Ratio (OR)|7.71|||<|0.001|TWO_SIDED|95.0|2.75|21.6|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥10% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||21.60|2.75|<0.001
71770602|NCT03036800|143040882|SUPERIORITY||Odds Ratio (OR)|6.14||||0.032|TWO_SIDED|95.0|1.16|32.32|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 16 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||32.32|1.16|0.032
71770603|NCT03036800|143040883|SUPERIORITY||Odds Ratio (OR)|11.48|||<|0.001|TWO_SIDED|95.0|3.8|34.67|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 32 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||34.67|3.80|<0.001
71725909|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.17|0.45||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.45|0.17|<0.001
71770604|NCT03036800|143040885|SUPERIORITY||Odds Ratio (OR)|13.63||||0.003|TWO_SIDED|95.0|2.47|75.09|||Regression, Logistic|||A logistic regression with a binary outcome of weight loss of ≥15% from baseline at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||75.09|2.47|0.003
71888256|NCT00282243|143297512|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|81.4|||||TWO_SIDED|90.0|77.88|85.08|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||85.08|77.88|
71888257|NCT01070329|143297531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
71888258|NCT01070329|143297532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.77|-2.62||The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||||-2.62|-5.77|<0.001
71888259|NCT01070329|143297533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.42||This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.42|-1.47|<0.001
71888260|NCT01070329|143297533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001|TWO_SIDED|95.0|-1.42|-0.53||This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.53|-1.42|<0.001
71888261|NCT01070329|143297533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||||-0.49|-1.41|<0.001
71888262|NCT01070329|143297533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.001|TWO_SIDED|95.0|-4.16|-1.61||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-1.61|-4.16|<0.001
71888263|NCT01070329|143297534|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||<0.001
71888264|NCT01070329|143297535|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.|Cochran-Mantel-Haenszel|||||||0.173
71770605|NCT03036800|143040886|SUPERIORITY||Odds Ratio (OR)|0.59||||0.601|TWO_SIDED|95.0|0.08|4.24|||Regression, Logistic|||A logistic regression with a binary outcome of maintenance of weight loss of ≥15% at 104 weeks was fitted. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||4.24|0.08|0.601
71770606|NCT03036800|143040887|SUPERIORITY||Mean Difference (Net)|-6.55|||<|0.001|TWO_SIDED|95.0|-7.81|-5.29|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 16 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.29|-7.81|<0.001
71888265|NCT01070329|143297536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|||||TWO_SIDED|95.0|-4.13|-1.48|||Mixed Models Analysis|Fourth gated secondary outcome measure. Statistical significance was not evaluated; prior gated secondary outcome measure failed (p\>0.05).||||-1.48|-4.13|
71888266|NCT01070329|143297537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.05|TWO_SIDED|95.0|0.0|3.34||This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.34|0.00|0.050
71888267|NCT01070329|143297537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.071|TWO_SIDED|95.0|-0.12|2.9||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.|ANCOVA|||||2.90|-0.12|0.071
71888268|NCT01070329|143297538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.05|TWO_SIDED|95.0|0.0|3.82||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.82|0.00|0.050
71888269|NCT01070329|143297538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.007|TWO_SIDED|95.0|0.5|3.1||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||3.10|0.50|0.007
71657919|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71888270|NCT01070329|143297538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.063|TWO_SIDED|95.0|-0.09|3.5||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.50|-0.09|0.063
71888271|NCT01070329|143297538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.004|TWO_SIDED|95.0|0.6|3.02||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.02|0.60|0.004
71888272|NCT01070329|143297539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-3.18|-0.96|||Mixed Models Analysis|Fifth gated secondary outcome measure. Statistical significance was not evaluated; the third gated secondary outcome measure failed (p\>0.05).||||-0.96|-3.18|
71888273|NCT01070329|143297540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.007|TWO_SIDED|95.0|-0.93|-0.15||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.93|0.007
71725910|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.39|0.15|<0.001
71770607|NCT03036800|143040888|SUPERIORITY||Mean Difference (Net)|-9.59|||<|0.001|TWO_SIDED|95.0|-11.3|-7.88|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 32 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-7.88|-11.30|<0.001
71657920|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657921|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71725911|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.35||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.35|0.13|<0.001
71725912|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|||<|0.001|TWO_SIDED|95.0|0.15|0.41||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||0.41|0.15|<0.001
71725913|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.12||||0.549|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.63|0.77|0.549
71725914|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.863|TWO_SIDED|95.0|0.66|1.42||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.42|0.66|0.863
71725915|NCT01559259|142966151|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.454|TWO_SIDED|95.0|0.57|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.||1.28|0.57|0.454
71725916|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-41.07|||<|0.001|TWO_SIDED|95.0|-59.56|-22.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.58|-59.56|<0.001
71725917|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.98|||<|0.001|TWO_SIDED|95.0|-59.41|-22.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.56|-59.41|<0.001
71725918|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.64|||<|0.001|TWO_SIDED|95.0|-57.49|-19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.79|-57.49|<0.001
71725919|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-38.11|||<|0.001|TWO_SIDED|95.0|-56.94|-19.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-19.28|-56.94|<0.001
71725920|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.13||||0.274|TWO_SIDED|95.0|-8.67|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-8.67|0.274
71657922|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71725921|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.89||||0.304|TWO_SIDED|95.0|-8.4|2.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.62|-8.40|0.304
71725922|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.96||||0.769|TWO_SIDED|95.0|-7.41|5.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.49|-7.41|0.769
71725923|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.19|||<|0.001|TWO_SIDED|95.0|-88.0|-54.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-54.38|-88.00|<0.001
71725924|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.99|||<|0.001|TWO_SIDED|95.0|-84.26|-49.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.72|-84.26|<0.001
71725925|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.47|||<|0.001|TWO_SIDED|95.0|-84.75|-50.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.19|-84.75|<0.001
71725926|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.76|||<|0.001|TWO_SIDED|95.0|-80.45|-45.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-45.07|-80.45|<0.001
71725927|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.53||||0.021|TWO_SIDED|95.0|-15.55|-1.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.50|-15.55|0.021
71725928|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.337|TWO_SIDED|95.0|-12.05|4.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.07|-12.05|0.337
71770608|NCT03036800|143040889|SUPERIORITY||Mean Difference (Net)|-13.51|||<|0.001|TWO_SIDED|95.0|-15.51|-11.51|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-11.51|-15.51|<0.001
71770609|NCT03036800|143040890|SUPERIORITY||Mean Difference (Net)|-9.3|||<|0.001|TWO_SIDED|95.0|-12.35|-6.26|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of relative weight change (%) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-6.26|-12.35|<0.001
71770610|NCT03036800|143040891|SUPERIORITY||Mean Difference (Net)|-6.16|||<|0.001|TWO_SIDED|95.0|-7.03|-5.28|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.28|-7.03|<0.001
71770611|NCT03036800|143040892|SUPERIORITY||Mean Difference (Net)|-4.22|||<|0.001|TWO_SIDED|95.0|-5.56|-2.89|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute BMI change (kg/m2) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-2.89|-5.56|<0.001
71770612|NCT03036800|143040893|SUPERIORITY||Median Difference (Net)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.96|-5.64|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 52 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-5.64|-11.96|<0.001
71770613|NCT03036800|143040894|SUPERIORITY||Median Difference (Net)|-9.59||||0.001|TWO_SIDED|95.0|-14.91|-4.27|||Regression, Linear|||A linear regression model was fitted for the continuous outcome of absolute waist circumference change (cm) from baseline at 104 weeks. The main covariate was randomised arm, with the model also being adjusted for the stratification variables: site and baseline body mass index (≥45kg/m2; \<45kg/m2).||-4.27|-14.91|0.001
71770614|NCT01077154|143040895|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7|TWO_SIDED|95.0|0.82|1.14|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.14|0.82|0.70
71888274|NCT01070329|143297540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.002|TWO_SIDED|95.0|-0.93|-0.22||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.22|-0.93|0.002
71725929|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.26||||0.204|TWO_SIDED|95.0|-13.28|2.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.76|-13.28|0.204
71725930|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-77.89|||<|0.001|TWO_SIDED|95.0|-92.29|-63.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-63.49|-92.29|<0.001
71725931|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.65|||<|0.001|TWO_SIDED|95.0|-86.71|-56.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.58|-86.71|<0.001
71725932|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-72.87|||<|0.001|TWO_SIDED|95.0|-88.06|-57.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.68|-88.06|<0.001
71725933|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-67.2|||<|0.001|TWO_SIDED|95.0|-82.87|-51.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-51.52|-82.87|<0.001
71725934|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.71||||0.007|TWO_SIDED|95.0|-18.2|-3.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.21|-18.20|0.007
71725935|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.99||||0.385|TWO_SIDED|95.0|-12.86|4.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.88|-12.86|0.385
71725936|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.29||||0.162|TWO_SIDED|95.0|-14.97|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.40|-14.97|0.162
71725937|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-76.81|||<|0.001|TWO_SIDED|95.0|-91.35|-62.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-62.27|-91.35|<0.001
71770615|NCT01077154|143040896|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.57|TWO_SIDED|95.0|0.91|1.19|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hzard ratio \< 1 favors denosumab.|||1.19|0.91|0.57
71770616|NCT01077154|143040897|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.26|TWO_SIDED|95.0|0.92|1.36|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.36|0.92|0.26
71770617|NCT01077154|143040898|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.22|0.83|0.94
71770618|NCT01077154|143040899|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.41|TWO_SIDED|95.0|0.92|1.21|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio \< 1 favors denosumab.|||1.21|0.92|0.41
71770619|NCT05985980|143040900|EQUIVALENCE|The null hypothesis is true that the ST/HR index (μV/bpm) ıs similar between the early and late follicular phases||||||0.521|||||||t-test, 2 sided|||||||0.521
71770620|NCT05985980|143040901|EQUIVALENCE|High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||||0.109|||||||ANOVA|||High-sensitive cardiac troponin T (hs-cTnT) levels before and after ETT at the early and late follicular phases are compared.||||0.109
71770621|NCT05985980|143040902|EQUIVALENCE|ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||||0.111|||||||t-test, 2 sided|||ETT maximal exercise capacity (METs score) is compared between the early and late follicular phases of menstrual cycle||||0.111
71770622|NCT05985980|143040903|EQUIVALENCE|ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||||0.414|||||||t-test, 2 sided|||ETT ST/HR slope (μV/bpm) is compared between the early and late follicular phases of menstrual cycle||||0.414
71725938|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-70.6|||<|0.001|TWO_SIDED|95.0|-85.79|-55.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-55.41|-85.79|<0.001
71725939|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.66|||<|0.001|TWO_SIDED|95.0|-87.0|-56.31||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.31|-87.00|<0.001
71725940|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
71725941|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.7||||0.007|TWO_SIDED|95.0|-19.86|-3.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-3.55|-19.86|0.007
71725942|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.94||||0.31|TWO_SIDED|95.0|-14.34|4.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.46|-14.34|0.310
71725943|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-7.36||||0.126|TWO_SIDED|95.0|-16.63|1.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.90|-16.63|0.126
71770623|NCT05985980|143040904|EQUIVALENCE|Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||||0.062|||||||t-test, 2 sided|||Maximal horizontal or down slope ST segment depression (mm) during exercise treadmill test is compared between the early and late follicular phases of menstrual cycle||||0.062
71770624|NCT05985980|143040905|EQUIVALENCE|Estrogen levels increase at the late follicular phase.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71770625|NCT02207946|143040906|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.28||0.144|TWO_SIDED|95.0|-1.02|0.16|||ANCOVA|||Least square (LS) means are from analysis of covariance (ANCOVA) with treatment and site included as fixed factors and baseline included as covariate.||0.16|-1.02|0.144
71770626|NCT01993836|143040980|OTHER||Spearman Correlation|-0.03|||||TWO_SIDED|95.0|-0.23|0.18||||||Correlation between 6-week change in Tau and continuous cognitive index||0.18|-0.23|
71770627|NCT01993836|143040980|OTHER||Spearman Correlation|-0.08|||||TWO_SIDED|95.0|-0.29|0.13||||||Correlation between 6-week change in Abeta and continuous cognitive index||0.13|-0.29|
71770628|NCT01993836|143040980|OTHER||Spearman Correlation|0.12|||||TWO_SIDED|95.0|-0.08|0.32||||||Correlation between 6-week change in P-Tau and continuous cognitive index||0.32|-0.08|
71770629|NCT01993836|143040981|OTHER||Spearman Correlation|0.02|||||TWO_SIDED|95.0|-0.19|0.22||||||Correlation between 6-week change in Tau/Abeta ratio and continuous cognitive index||0.22|-0.19|
71770630|NCT01993836|143040981|OTHER||Spearman Correlation|0.16|||||TWO_SIDED|95.0|-0.05|0.34||||||Correlation between 6-week change in P-Tau/Abeta ratio and continuous cognitive index||0.34|-0.05|
71830635|NCT01149369|143166299|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.72
71830636|NCT01149369|143166300|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.001|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.001
71770631|NCT01993836|143040982|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
71770632|NCT01993836|143040983|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau Change between anesthetic groups||||0.532
71770633|NCT01993836|143040983|OTHER|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Abeta Change between anesthetic groups||||0.565
71770634|NCT01993836|143040983|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau Change between anesthetic groups||||0.110
71770635|NCT01993836|143040984|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau/Abeta ratio Change between anesthetic groups||||0.439
71770636|NCT01993836|143040984|OTHER|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau/Abeta Change between anesthetic groups||||0.082
71770637|NCT01993836|143040985|OTHER|||||||0.801|||||||Wilcoxon Signed Rank|||||||0.801
71770638|NCT04369924|143040998|SUPERIORITY||F test for time by condition interaction|1.49||||0.25|TWO_SIDED||||||ANOVA|||||||.25
71770639|NCT04369924|143040999|SUPERIORITY||F test for time by condition interaction|2.8||||0.12|TWO_SIDED||||||ANOVA|||||||.12
71770640|NCT04369924|143041000|SUPERIORITY||F test for time by condition interaction|0.7||||0.7|TWO_SIDED||||||ANOVA|||||||.70
71770641|NCT04369924|143041001|SUPERIORITY||F test for time by condition interaction|3.67||||0.07|TWO_SIDED||||||ANOVA|||||||.07
71770642|NCT04369924|143041002|SUPERIORITY||Slope|0.16||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||.82
71770643|NCT04369924|143041003|SUPERIORITY||Slope|-2.41||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||.59
71888275|NCT01070329|143297541|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.021
71888276|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.85|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.85|<0.001
71888277|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.003|TWO_SIDED|95.0|-0.64|-0.13||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.13|-0.64|0.003
71725944|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-75.64|||<|0.001|TWO_SIDED|95.0|-90.35|-60.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-60.93|-90.35|<0.001
71725945|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-66.43|||<|0.001|TWO_SIDED|95.0|-81.99|-50.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-50.88|-81.99|<0.001
71888278|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.75|-0.22||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.22|-0.75|<0.001
71888279|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.86|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.27|-0.86|<0.001
71725946|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-69.33|||<|0.001|TWO_SIDED|95.0|-84.96|-53.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-53.71|-84.96|<0.001
71725947|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-65.19|||<|0.001|TWO_SIDED|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-49.34|-81.03|<0.001
71830637|NCT01149369|143166301|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.04
71830638|NCT01149369|143166302|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.14
71830639|NCT01149369|143166303|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.07|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.07
71830640|NCT01149369|143166304|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.19|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||||0.2|-0.8|0.19
71830641|NCT01149369|143166305|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||-0.0|-0.9|0.04
71830642|NCT01149369|143166306|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||||-0.1|-1.0|0.02
71830643|NCT01149369|143166307|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
71830644|NCT01149369|143166308|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.09|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.09
71830645|NCT01149369|143166309|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.17|TWO_SIDED|95.0|-7.0|0.1|||ANCOVA|||||0.1|-7|0.17
71888280|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.008|TWO_SIDED|95.0|-0.75|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.75|0.008
71888281|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.004|TWO_SIDED|95.0|-0.8|-0.15||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.80|0.004
71888282|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.12|-0.72|0.006
71888283|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.012|TWO_SIDED|95.0|-0.72|-0.09||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.09|-0.72|0.012
71888284|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.029|TWO_SIDED|95.0|-0.7|-0.04||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.04|-0.70|0.029
71888285|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.037|TWO_SIDED|95.0|-0.75|-0.02||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.02|-0.75|0.037
71888286|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.006|TWO_SIDED|95.0|-0.81|-0.14||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.14|-0.81|0.006
71888287|NCT01070329|143297542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.004|TWO_SIDED|95.0|-0.74|-0.15||This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.15|-0.74|0.004
71888288|NCT01070329|143297543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.49||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.49|-0.90|<0.001
71888289|NCT01070329|143297544|SUPERIORITY_OR_OTHER|||||||0.116||95.0||||This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.116
71888290|NCT06062264|143297549|SUPERIORITY||Adjusted Risk Ratio|1.03|||||TWO_SIDED|95.0|1.0|1.06||||||Comparing the risk of receiving an influenza vaccination|Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|1.06|1.00|
71725948|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-10.61||||0.016|TWO_SIDED|95.0|-19.02|-2.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-2.19|-19.02|0.016
71725949|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-0.69||||0.895|TWO_SIDED|95.0|-10.69|9.32||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.32|-10.69|0.895
71888291|NCT06062264|143297549|SUPERIORITY||Adjusted Risk Ratio|1.02|||||TWO_SIDED|95.0|0.99|1.06|||||Adjusted risk ratio. These results compare arms which received portal-based PCP video reminder messages to the arm receiving standard health system portal messages (control).|Comparing the risk of receiving an influenza vaccination||1.06|0.99|
71888292|NCT04233229|143297601|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|27.4|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|15.0|39.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||39.8|15.0|<.001
71888293|NCT04233229|143297602|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during diurnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|23.0|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|10.6|35.5||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||35.5|10.6|<.001
71888294|NCT04233229|143297603|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time In Range (TIR) during nocturnal period at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|40.8|STANDARD_ERROR_OF_MEAN|7.2|<|0.001|TWO_SIDED|95.0|25.8|55.8||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||55.8|25.8|<.001
71657923|NCT02504671|142831748|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71888295|NCT04233229|143297604|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-27.7|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-40.5|-15.0||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-15.0|-40.5|<.001
71725950|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.09||||0.308|TWO_SIDED|95.0|-14.8|4.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.62|-14.80|0.308
71725951|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-71.36|||<|0.001|TWO_SIDED|95.0|-86.58|-56.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-56.13|-86.58|<0.001
71725952|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.11|||<|0.001|TWO_SIDED|95.0|-78.04|-46.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.19|-78.04|<0.001
71725953|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-64.57|||<|0.001|TWO_SIDED|95.0|-80.64|-48.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.50|-80.64|<0.001
71725954|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-59.84|||<|0.001|TWO_SIDED|95.0|-76.12|-43.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-43.55|-76.12|<0.001
71725955|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.49||||0.028|TWO_SIDED|95.0|-21.63|-1.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-1.35|-21.63|0.028
71725956|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-1.88||||0.747|TWO_SIDED|95.0|-13.15|9.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.38|-13.15|0.747
71725957|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-5.88||||0.303|TWO_SIDED|95.0|-16.88|5.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.12|-16.88|0.303
71725958|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-62.49|||<|0.001|TWO_SIDED|95.0|-78.64|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.34|-78.64|<0.001
71725959|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-60.09|||<|0.001|TWO_SIDED|95.0|-76.15|-44.02||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-44.02|-76.15|<0.001
71830646|NCT01149369|143166310|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.009|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||||-0.2|-1.1|0.009
71830647|NCT01149369|143166311|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.004|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||||-0.2|-1.2|0.004
71830648|NCT01149369|143166312|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|0.10
71830649|NCT01149369|143166313|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.13|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.13
71830650|NCT01149369|143166314|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.98|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||||0.4|-0.5|0.98
71830651|NCT01149369|143166315|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.007|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.007
71888296|NCT04233229|143297605|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Above Range (TAR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|-20.1|STANDARD_ERROR_OF_MEAN|5.9||0.003|TWO_SIDED|95.0|-32.4|-7.9||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-7.9|-32.4|0.003
71888297|NCT04233229|143297606|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.79|TWO_SIDED|95.0|-1.0|1.3||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||1.3|-1.0|0.79
71725960|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-63.45|||<|0.001|TWO_SIDED|95.0|-79.64|-47.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-47.27|-79.64|<0.001
71725961|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.41|||<|0.001|TWO_SIDED|95.0|-70.1|-36.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.72|-70.10|<0.001
71725962|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-9.14||||0.137|TWO_SIDED|95.0|-21.18|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||2.90|-21.18|0.137
71725963|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.34||||0.311|TWO_SIDED|95.0|-18.39|5.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.71|-18.39|0.311
71725964|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-11.23||||0.067|TWO_SIDED|95.0|-22.97|0.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||0.52|-22.97|0.067
71725965|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-51.54|||<|0.001|TWO_SIDED|95.0|-68.42|-34.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-34.66|-68.42|<0.001
71725966|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-57.01|||<|0.001|TWO_SIDED|95.0|-73.27|-40.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.76|-73.27|<0.001
71725967|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-53.21|||<|0.001|TWO_SIDED|95.0|-70.16|-36.26||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-36.26|-70.16|<0.001
71725968|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.82|||<|0.001|TWO_SIDED|95.0|-64.81|-30.83||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.83|-64.81|<0.001
71725969|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-3.52||||0.604|TWO_SIDED|95.0|-16.89|9.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.85|-16.89|0.604
71725970|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-8.78||||0.184|TWO_SIDED|95.0|-21.5|3.94||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.94|-21.50|0.184
71725971|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-6.43||||0.34|TWO_SIDED|95.0|-19.56|6.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||6.70|-19.56|0.340
71725972|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-40.27|||<|0.001|TWO_SIDED|95.0|-57.67|-22.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-22.88|-57.67|<0.001
71725973|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-47.24|||<|0.001|TWO_SIDED|95.0|-64.21|-30.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-30.27|-64.21|<0.001
71725974|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-43.15|||<|0.001|TWO_SIDED|95.0|-60.57|-25.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-25.72|-60.57|<0.001
71725975|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-44.45|||<|0.001|TWO_SIDED|95.0|-61.55|-27.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-27.34|-61.55|<0.001
71725976|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.29||||0.548|TWO_SIDED|95.0|-9.8|18.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.38|-9.80|0.548
71725977|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.51||||0.721|TWO_SIDED|95.0|-16.2|11.18||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.18|-16.20|0.721
71725978|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.44||||0.951|TWO_SIDED|95.0|-13.47|14.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.35|-13.47|0.951
71725979|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-29.13||||0.005|TWO_SIDED|95.0|-46.66|-11.59||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-11.59|-46.66|0.005
71725980|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.3||||0.001|TWO_SIDED|95.0|-51.62|-16.97||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-16.97|-51.62|0.001
71725981|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-36.26|||<|0.001|TWO_SIDED|95.0|-53.8|-18.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-18.73|-53.80|<0.001
71725982|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-34.56|||<|0.001|TWO_SIDED|95.0|-51.77|-17.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-17.35|-51.77|<0.001
71725983|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|5.45||||0.455|TWO_SIDED|95.0|-8.89|19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||19.79|-8.89|0.455
71770644|NCT02554279|143041004|NON_INFERIORITY|The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin.|Absolute difference|4.7|||||TWO_SIDED|95.0|-2.7|12.1||||||Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%.||12.1|-2.7|
71770645|NCT02554279|143041005|OTHER||Absolute difference|1.2|||||TWO_SIDED|95.0|-6.6|8.9||||||||8.9|-6.6|
71770646|NCT02554279|143041006|OTHER||Absolute difference|3.8|||||TWO_SIDED|95.0|-3.8|11.3||||||||11.3|-3.8|
71770647|NCT02554279|143041007|OTHER||Absolute difference|-9.5|||||TWO_SIDED|95.0|-19.2|0.2||||||||0.2|-19.2|
71830652|NCT01149369|143166316|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.06|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||||0.0|-0.9|0.06
71770648|NCT01933789|143041016|SUPERIORITY||Probit regression coefficient|1.145|||<|0.001|TWO_SIDED|95.0|0.844|1.446||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.446|0.844|<0.001
71725984|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.43||||0.953|TWO_SIDED|95.0|-13.8|14.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.65|-13.80|0.953
71725985|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-2.48||||0.731|TWO_SIDED|95.0|-16.63|11.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.66|-16.63|0.731
71725986|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-22.63||||0.024|TWO_SIDED|95.0|-39.97|-5.29||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-5.29|-39.97|0.024
71725987|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-26.87||||0.009|TWO_SIDED|95.0|-44.12|-9.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-9.62|-44.12|0.009
71725988|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-30.76||||0.003|TWO_SIDED|95.0|-48.36|-13.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-13.16|-48.36|0.003
71725989|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-27.26||||0.007|TWO_SIDED|95.0|-44.51|-10.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.00|-44.51|0.007
71725990|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|4.66||||0.516|TWO_SIDED|95.0|-9.5|18.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.82|-9.50|0.516
71725991|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|0.55||||0.939|TWO_SIDED|95.0|-13.63|14.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||14.72|-13.63|0.939
71770649|NCT01933789|143041017|SUPERIORITY||Probit regression coefficient|1.251|||<|0.001|TWO_SIDED|95.0|0.92|1.583||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.583|0.920|<0.001
71830653|NCT01149369|143166317|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|||||-0.2|-1.0|0.001
71830654|NCT01149369|143166318|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.28
71830655|NCT01149369|143166319|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||||0.0|-1.0|0.05
71830656|NCT01149369|143166320|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.08
71830657|NCT01149369|143166321|SUPERIORITY|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.53|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|||||0.6|-1.1|0.53
71830658|NCT01149369|143166322|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.38|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|||||0.5|-1.3|0.38
71725992|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.53||||0.536|TWO_SIDED|95.0|-18.86|9.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.80|-18.86|0.536
71725993|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-15.81||||0.107|TWO_SIDED|95.0|-33.02|1.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.41|-33.02|0.107
71725994|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-23.71||||0.019|TWO_SIDED|95.0|-40.91|-6.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-6.51|-40.91|0.019
71725995|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-28.44||||0.006|TWO_SIDED|95.0|-45.99|-10.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-10.88|-45.99|0.006
71725996|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-25.04||||0.012|TWO_SIDED|95.0|-42.23|-7.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-7.85|-42.23|0.012
71725997|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|9.16||||0.195|TWO_SIDED|95.0|-4.75|23.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.08|-4.75|0.195
71725998|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|1.48||||0.835|TWO_SIDED|95.0|-12.54|15.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||15.50|-12.54|0.835
71725999|NCT01559259|142966152|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion|-4.41||||0.542|TWO_SIDED|95.0|-18.61|9.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.79|-18.61|0.542
71726000|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|<0.001
71726001|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.83|||<|0.001|TWO_SIDED|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||1.01|0.79|< 0.001
71726002|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||<|0.001|TWO_SIDED|95.0|0.73|0.99||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.99|0.73|< 0.001
71726003|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.65|0.95||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.95|0.65|< 0.001
71726004|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.174|TWO_SIDED|95.0|-0.07|0.37||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.37|-0.07|0.174
71770650|NCT01933789|143041018|SUPERIORITY||Probit regression coefficient|1.381|||<|0.001|TWO_SIDED|95.0|1.046|1.715||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.|||1.715|1.046|<0.001
71770651|NCT01933789|143041020|SUPERIORITY||Probit regression coefficient|0.334||||0.073|TWO_SIDED|95.0|-0.031|0.699||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|Occurrence of goal-concordant care||0.699|-0.031|0.073
71726005|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.722|TWO_SIDED|95.0|-0.18|0.26||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.26|-0.18|0.722
71726006|NCT01559259|142966153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.365|TWO_SIDED|95.0|-0.32|0.11||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.||0.11|-0.32|0.365
71888298|NCT04233229|143297607|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and Time Below Range (TBR) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.84|TWO_SIDED|95.0|-0.3|0.4||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||0.4|-0.3|0.84
71888299|NCT04233229|143297608|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and glucose variability (% CV Coefficient of Variation) at baseline (during the last 14 days completed continuous glucose monitor recording at the end of the study selection period)|Adjusted means difference|3.7|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-0.2|7.6||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||7.6|-0.2|0.060
71888300|NCT04233229|143297609|SUPERIORITY|Analysis of covariance (ANCOVA) model with 2 factors: HbA1c value at baseline and study group|Adjusted means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.9|-0.7||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||-0.7|-1.9|<.001
71888301|NCT04233229|143297610|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and total daily insulin dose at selection|Adjusted means difference|-18.5|STANDARD_ERROR_OF_MEAN|28.5||0.52|TWO_SIDED|95.0|-78.2|41.2||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||41.2|-78.2|0.52
71726007|NCT05425732|142966154|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.9|||||TWO_SIDED|96.0|-2.8|1.1|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||1.1|-2.8|
71726008|NCT05425732|142966154|OTHER|Miettinen \& Nurminen method|Difference in Percent|-12.2|||||TWO_SIDED|95.0|-16.2|-8.2|||||V116 minus PCV20|Injection site pain: estimated difference in percent||-8.2|-16.2|
71726009|NCT05425732|142966154|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.3|||||TWO_SIDED|95.0|-4.4|-0.2|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||-0.2|-4.4|
71726010|NCT05425732|142966154|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.6|10.3|||||V116 minus PCV20|Injection site erythema: estimated difference in percent||10.3|-6.6|
71770652|NCT01933789|143041021|SUPERIORITY||Probit regression coefficient|0.481||||0.017|TWO_SIDED|95.0|0.085|0.877||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient's treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|||0.877|0.085|0.017
71888302|NCT04233229|143297611|SUPERIORITY|Analysis of covariance (ANCOVA) model adjusted on the HbA1c stratification factor and body weight at study initiation visit|Adjusted means difference|2.8|STANDARD_ERROR_OF_MEAN|1.6||0.08|TWO_SIDED|95.0|-0.4|6.1||Study group effect|ANCOVA||Between-group adjusted means difference is calculated as analysis of covariance adjusted mean in Intervention Group - adjusted mean in Usual Care Group.|||6.1|-0.4|0.08
71888303|NCT02631538|143297632|OTHER||Least square (LS) mean difference|-2.86|STANDARD_ERROR_OF_MEAN|1.758|||TWO_SIDED|95.0|-6.38|0.67|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.67|-6.38|
71888304|NCT02631538|143297632|OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.382|||TWO_SIDED|95.0|-3.75|1.78|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.78|-3.75|
71888305|NCT02631538|143297632|OTHER||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.442|||TWO_SIDED|95.0|-3.52|2.26|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.26|-3.52|
71726011|NCT05425732|142966154|OTHER|Miettinen \& Nurminen method|Difference in Percent|-2.5|||||TWO_SIDED|95.0|-12.7|8.6|||||V116 minus PCV20|Injection site pain: estimated difference in percent||8.6|-12.7|
71726012|NCT05425732|142966154|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-9.2|7.9|||||V116 minus PCV20|Injection site swelling: estimated difference in percent||7.9|-9.2|
71726013|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.6|||||TWO_SIDED|95.0|-2.7|3.8|||||V116 minus PCV20|Fatigue: estimated difference in percent||3.8|-2.7|
71726014|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|-1.5|||||TWO_SIDED|95.0|-4.1|1.2|||||V116 minus PCV20|Headache: estimated difference in percent||1.2|-4.1|
71726015|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|-0.8|||||TWO_SIDED|96.0|-2.8|1.2|||||V116 minus PCV20|Myalgia: estimated difference in percent||1.2|-2.8|
71726016|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||||V116 minus PCV20|Pyrexia: estimated difference in percent||1.0|-1.0|
71726017|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.3|17.6|||||V116 minus PCV20|Fatigue: estimated difference in percent||17.6|-5.3|
71726018|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|5.5|||||TWO_SIDED|5.0|-5.5|15.5|||||V116 minus PCV20|Headache: estimated difference in percent||15.5|-5.5|
71888306|NCT02631538|143297632|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.732|||TWO_SIDED|95.0|-5.34|1.6|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.60|-5.34|
71726019|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-6.8|10.6|||||V116 minus PCV20|Myalgia: estimated difference in percent||10.6|-6.8|
71726020|NCT05425732|142966155|OTHER|Miettinen \& Nurminen method|Difference in Percent|2.5|||||TWO_SIDED|95.0|-2.2|6.2|||||V116 minus PCV20|Pyrexia: estimated difference in percent||6.2|-2.2|
71726021|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.4|1.72||1-sided|cLDA model||V116/PCV20|Serotype 3: V116/PCV20 GMT Ratio||1.72|1.40|<0.001
71726022|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.88|||cLDA model||V116/PCV20|Serotype 6A: V116/PCV20 GMT Ratio||0.88|0.68|<0.001
71726023|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.95|1.18|||cLDA model||V116/PCV20|Serotype 7F: V116/PCV20 GMT Ratio||1.18|0.95|<0.001
71726024|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.38|||<|0.001|TWO_SIDED|95.0|1.25|1.53|||cLDA model||V116/PCV20|Serotype 8: V116/PCV20 GMT Ratio||1.53|1.25|<0.001
71726025|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||cLDA model||V116/PCV20|Serotype 10A: V116/PCV20 GMT Ratio||0.93|0.75|<0.001
71726026|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.39|1.72|||cLDA model||V116/PCV20|Serotype 11A: V116/PCV20 GMT Ratio||1.72|1.39|<0.001
71726027|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.92|1.21|||cLDA model||V116/PCV20|Serotype 12F: V116/PCV20 GMT Ratio||1.21|0.92|<0.001
71726028|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.69|0.84|||cLDA model||V116/PCV20|Serotype 19A: V116/PCV20 GMT Ratio||0.84|0.69|<0.001
71726029|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.72|0.92|||cLDA model||V116/PCV20|Serotype 22F: V116/PCV20 GMT Ratio||0.92|0.72|<0.001
71726030|NCT05425732|142966157|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|1.01|1.32|||cLDA model||V116/PCV20|Serotype 33F: V116/PCV20 GMT Ratio||1.32|1.01|<0.001
71657924|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71726031|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|4.55|||<|0.001|TWO_SIDED|95.0|4.12|5.04|||cLDA model||V116/PCV20|Serotype 9N: V116/PCV20 GMT Ratio||5.04|4.12|<0.001
71726032|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|3.3|||<|0.001|TWO_SIDED|95.0|2.91|3.74|||cLDA model||V116/PCV20|Serotype 15A: V116/PCV20 GMT Ratio||3.74|2.91|<0.001
71726033|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|2.03|||<|0.001|TWO_SIDED|95.0|1.77|2.34|||cLDA model||V116/PCV20|Serotype 15C: V116/PCV20 GMT Ratio||2.34|1.77|<0.001
71726034|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|5.75|||<|0.001|TWO_SIDED|95.0|5.16|6.41|||cLDA model||V116/PCV20|Serotype 16F: V116/PCV20 GMT Ratio||6.41|5.16|<0.001
71726035|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|16.86|||<|0.001|TWO_SIDED|95.0|14.9|19.09|||cLDA model||V116/PCV20|Serotype 17F: V116/PCV20 GMT Ratio||19.09|14.90|<0.001
71726036|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|9.66|||<|0.001|TWO_SIDED|95.0|8.66|10.79|||cLDA model||V116/PCV20|Serotype 20A: V116/PCV20 GMT Ratio||10.79|8.66|<0.001
71726037|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|8.1|||<|0.001|TWO_SIDED|95.0|6.86|9.55|||cLDA model||V116/PCV20|Serotype 23A: V116/PCV20 GMT Ratio||9.55|6.86|<0.001
71726038|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|10.09|||<|0.001|TWO_SIDED|95.0|8.48|12.0|||cLDA model||V116/PCV20|Serotype 23B: V116/PCV20 GMT Ratio||12.00|8.48|<0.001
71726039|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|38.71|||<|0.001|TWO_SIDED|95.0|33.87|44.25|||cLDA model||V116/PCV20|Serotype 24F: V116/PCV20 GMT Ratio||44.25|33.87|<0.001
71726040|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|21.69|||<|0.001|TWO_SIDED|95.0|18.68|25.18|||cLDA model||V116/PCV20|Serotype 31: V116/PCV20 GMT Ratio||25.18|18.68|<0.001
71726041|NCT05425732|142966157|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being \> 2.0 (one-sided p-value \< 0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.59|6.8|||cLDA model||V116/PCV20|Serotype 35B: V116/PCV20 GMT Ratio||6.80|5.59|<0.001
71726042|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|44.7|||<|0.001|TWO_SIDED|95.0|40.7|48.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 9N: V116-PCV20 Percentage Difference||48.6|40.7|<0.001
71726043|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|30.9|||<|0.001|TWO_SIDED|95.0|25.8|35.8||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15A: V116-PCV20 Percentage Difference||35.8|25.8|<0.001
71726044|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|9.2|||<|0.001|TWO_SIDED|95.0|5.6|12.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 15C: V116-PCV20 Percentage Difference||12.9|5.6|<0.001
71726045|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|51.1|||<|0.001|TWO_SIDED|95.0|47.1|54.9||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 16F: V116-PCV20 Percentage Difference||54.9|47.1|<0.001
71726046|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|66.3|||<|0.001|TWO_SIDED|95.0|62.8|69.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 17F: V116-PCV20 Percentage Difference||69.6|62.8|<0.001
71726047|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|57.7|||<|0.001|TWO_SIDED|95.0|54.2|61.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 20A: V116-PCV20 Percentage Difference||61.1|54.2|<0.001
71726048|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|42.2|||<|0.001|TWO_SIDED|95.0|37.6|46.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23A: V116-PCV20 Percentage Difference||46.6|37.6|<0.001
71726049|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|35.9|||<|0.001|TWO_SIDED|95.0|32.1|39.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 23B: V116-PCV20 Percentage Difference||39.6|32.1|<0.001
71726050|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|74.2|||<|0.001|TWO_SIDED|95.0|71.1|77.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype24F: V116-PCV20 Percentage Difference||77.1|71.1|<0.001
71888307|NCT02631538|143297632|OTHER||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|1.422|||TWO_SIDED|95.0|-2.5|3.2|||||Week 12. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.20|-2.50|
71888308|NCT02631538|143297632|OTHER||LS mean difference|-2.45|STANDARD_ERROR_OF_MEAN|1.607|||TWO_SIDED|95.0|-5.67|0.77|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.77|-5.67|
71726051|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|58.6|||<|0.001|TWO_SIDED|95.0|54.8|62.1||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype 31: V116-PCV20 Percentage Difference||62.1|54.8|<0.001
71726052|NCT05425732|142966158|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PCV20\] between the percentages of participants with a ≥4-fold rise from baseline being \>10 percentage points (one-sided p-value \< 0.025).|Percent Difference|53.2|||<|0.001|TWO_SIDED|95.0|49.6|56.6||1-sided|Stratified Miettinen & Nurminen||V116 minus PCV20|Serotype35B: V116-PCV20 Percentage Difference||56.6|49.6|<0.001
71726053|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.9|1.33||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 3: V116 18-49 years/V116 50-64 years GMT Ratio||1.33|0.90|<0.001
71726054|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.06|||<|0.001|TWO_SIDED|95.0|1.61|2.62||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 6A: V116 18-49 years/V116 50-64 years GMT Ratio||2.62|1.61|<0.001
71888309|NCT02631538|143297632|OTHER||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.265|||TWO_SIDED|95.0|-3.99|1.08|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.08|-3.99|
71888310|NCT02631538|143297632|OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.305|||TWO_SIDED|95.0|-2.68|2.55|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.55|-2.68|
71657925|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657926|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71770653|NCT01933789|143041022|SUPERIORITY||Probit regression coefficient|2.022||||0.01|TWO_SIDED|95.0|0.476|3.569||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the latent variable as measured at baseline.|Control group coded 0; intervention group coded 1.|||3.569|0.476|0.010
71770654|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|2.209||||0.001|TWO_SIDED|95.0|0.939|3.479||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.479|0.939|0.001
71770655|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|1.237||||0.122|TWO_SIDED|95.0|-0.33|2.804||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."||2.804|-0.330|0.122
71770656|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|2.329||||0.098|TWO_SIDED|95.0|-0.426|5.083||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.083|-0.426|0.098
71770657|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|1.573||||0.352|TWO_SIDED|95.0|-1.742|4.887||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Adjusted for outcome variable as measured at baseline: pt. minority status, education, income; clinician type \& specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect."||4.887|-1.742|0.352
71770658|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|4.625|||<|0.001|TWO_SIDED|95.0|2.06|7.19||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect."||7.190|2.060|<0.001
71770659|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|2.404||||0.002|TWO_SIDED|95.0|0.898|3.909||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect."||3.909|0.898|0.002
71830659|NCT01149369|143166323|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-2.2||||0.09|TWO_SIDED|95.0|-4.7|0.4|||ANCOVA|||||0.4|-4.7|0.09
71830660|NCT01149369|143166324|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.8||||0.28|TWO_SIDED|95.0|-5.2|1.5|||ANCOVA|||||1.5|-5.2|0.28
71830661|NCT01149369|143166325|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.6||||0.3|TWO_SIDED|95.0|-4.6|1.4|||ANCOVA|||||1.4|-4.6|0.30
71830662|NCT01149369|143166326|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-21.2||||0.4|TWO_SIDED|95.0|-70.5|28.1|||ANCOVA|||||28.1|-70.5|0.40
71657927|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657928|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657929|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71888311|NCT02631538|143297632|OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|1.584|||TWO_SIDED|95.0|-4.17|2.18|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.18|-4.17|
71726055|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|5.0|1.23|1.84||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 7F: V116 18-49 years/V116 50-64 years GMT Ratio||1.84|1.23|<0.001
71726056|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.5|||<|0.001|TWO_SIDED|95.0|1.26|1.79||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 8: V116 18-49 years/V116 50-64 years GMT Ratio||1.79|1.26|<0.001
71726057|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.59|2.43||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 9N: V116 18-49 years/V116 50-64 years GMT Ratio||2.43|1.59|<0.001
71726058|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.92||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 10A: V116 18-49 years/V116 50-64 years GMT Ratio||1.92|1.26|<0.001
71726059|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 11A: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
71726060|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.73|||<|0.001|TWO_SIDED|95.0|1.37|2.17||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 12F: V116 18-49 years/V116 50-64 years GMT Ratio||2.17|1.37|<0.001
71726061|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.55|2.37||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15A: V116 18-49 years/V116 50-64 years GMT Ratio||2.37|1.55|<0.001
71726062|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.36|2.35||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15C: V116 18-49 years/V116 50-64 years GMT Ratio||2.35|1.36|<0.001
71726063|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.26|1.91||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 16F: V116 18-49 years/V116 50-64 years GMT Ratio||1.91|1.26|<0.001
71726064|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.02||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 17F: V116 18-49 years/V116 50-64 years GMT Ratio||2.02|1.26|<0.001
71726065|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|0.97|1.4||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 19A: V116 18-49 years/V116 50-64 years GMT Ratio||1.40|0.97|<0.001
71726066|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 20A: V116 18-49 years/V116 50-64 years GMT Ratio||2.18|1.39|<0.001
71726067|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.99|||<|0.001|TWO_SIDED|95.0|1.58|2.49||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 22F: V116 18-49 years/V116 50-64 years GMT Ratio||2.49|1.58|<0.001
71726068|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.87|||<|0.001|TWO_SIDED|95.0|1.43|2.44||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23A: V116 18-49 years/V116 50-64 years GMT Ratio||2.44|1.43|<0.001
71726069|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.11|2.04||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 23B: V116 18-49 years/V116 50-64 years GMT Ratio||2.04|1.11|<0.001
71726070|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.36|||<|0.001|TWO_SIDED|95.0|1.1|1.67||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 24F: V116 18-49 years/V116 50-64 years GMT Ratio||1.67|1.10|<0.001
71726071|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.63|2.69||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 31: V116 18-49 years/V116 50-64 years GMT Ratio||2.69|1.63|<0.001
71888312|NCT02631538|143297632|OTHER||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-1.2|3.97|||||Week 24. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.97|-1.20|
71888313|NCT02631538|143297632|OTHER||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.845|||TWO_SIDED|95.0|-4.66|2.73|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.73|-4.66|
71888314|NCT02631538|143297632|OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.449|||TWO_SIDED|95.0|-2.76|3.05|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.05|-2.76|
71888315|NCT02631538|143297632|OTHER||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.498|||TWO_SIDED|95.0|-2.15|3.86|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.86|-2.15|
71888316|NCT02631538|143297632|OTHER||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.817|||TWO_SIDED|95.0|-4.76|2.53|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.53|-4.76|
71888317|NCT02631538|143297632|OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.476|||TWO_SIDED|95.0|-2.25|3.66|||||Week 36. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.66|-2.25|
71888318|NCT02631538|143297632|OTHER||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-5.95|0.34|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.34|-5.95|
71888319|NCT02631538|143297632|OTHER||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.237|||TWO_SIDED|95.0|-3.39|1.56|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.56|-3.39|
71888320|NCT02631538|143297632|OTHER||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.275|||TWO_SIDED|95.0|-3.91|1.2|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.20|-3.91|
71888321|NCT02631538|143297632|OTHER||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|1.548|||TWO_SIDED|95.0|-4.99|1.21|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.21|-4.99|
71888322|NCT02631538|143297632|OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|1.261|||TWO_SIDED|95.0|-2.97|2.08|||||Week 52. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||2.08|-2.97|
71726072|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.52|2.57||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 33F: V116 18-49 years/V116 50-64 years GMT Ratio||2.57|1.52|<0.001
71726073|NCT05425732|142966159|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.54|||<|0.001|TWO_SIDED|95.0|1.26|1.87||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 35B: V116 18-49 years/V116 50-64 years GMT Ratio||1.87|1.26|<0.001
71726074|NCT05425732|142966160|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."||||||0.667||||||1-sided|Clopper-Pearson method.|||Serotype 6C||||0.667
71726075|NCT05425732|142966160|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4-fold rise from baseline to 30 days postvaccination being \> 50 percentage points (one-sided p-value \< 0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method.|||Serotype 15B||||<0.001
71888323|NCT02631538|143297632|OTHER||LS mean difference|-3.99|STANDARD_ERROR_OF_MEAN|1.699|||TWO_SIDED|95.0|-7.39|-0.58|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||-0.58|-7.39|
71888324|NCT02631538|143297632|OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|1.336|||TWO_SIDED|95.0|-4.54|0.81|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||0.81|-4.54|
71657930|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71726076|NCT05425732|142966161|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT Ratio|2.05|||||TWO_SIDED|95.0|1.52|2.77|||||V116 18-49 years/V116 50-64 years|Serotype 6C: V116 18-49 years/V116 50-64 years GMT Ratio||2.77|1.52|
71888325|NCT02631538|143297632|OTHER||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|1.379|||TWO_SIDED|95.0|-4.12|1.41|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.41|-4.12|
71888326|NCT02631538|143297632|OTHER||LS mean difference|-2.12|STANDARD_ERROR_OF_MEAN|1.674|||TWO_SIDED|95.0|-5.47|1.23|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||1.23|-5.47|
71888327|NCT02631538|143297632|OTHER||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-2.21|3.24|||||Week 68. Analysis was performed using mixed effects repeated measures model, with Baseline, treatment, visit and interactions of visit with treatment as fixed effects and participant as a random effect.|||3.24|-2.21|
71888328|NCT00964431|143297637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.545|STANDARD_ERROR_OF_MEAN|1.8912|<|0.001|TWO_SIDED|95.0|5.816|13.275|||ANCOVA|||||13.275|5.816|<0.001
71726077|NCT05425732|142966161|OTHER|A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being \> 0.5 (one-sided p-value \< 0.025).|GMT|2.02|||<|0.001|TWO_SIDED|95.0|1.57|2.6||1-sided|LDA model||V116 18-49 years/V116 50-64 years|Serotype 15B: V116 18-49 years/V116 50-64 years GMT ratio||2.60|1.57|<0.001
71726078|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.35|1.6|||||V116/PCV20|Serotype 3: V116/PCV20 GMC Ratio||1.60|1.35|
71726079|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.7|0.89|||||V116/PCV20|Serotype 6A: V116/PCV20 GMC Ratio||0.89|0.70|
71726080|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 7F: V116/PCV20 GMC Ratio||1.18|0.95|
71770660|NCT01933789|143041023|SUPERIORITY||Tobit regression coefficient|2.455||||0.075|TWO_SIDED|95.0|-0.25|5.159||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician type.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician's quality of communication about patient's religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect."||5.159|-0.250|0.075
71770661|NCT01933789|143041024|SUPERIORITY||Probit regression coefficient|-0.103||||0.369|TWO_SIDED|95.0|-0.327|0.122||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent depression variable and for the patient racial/ethnic minority status.|Control group coded 0; intervention group coded 1.|Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.||0.122|-0.327|0.369
71770662|NCT01933789|143041025|SUPERIORITY||Probit regression coefficient|0.263||||0.536|TWO_SIDED|95.0|-0.571|1.097||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score.|Control group coded 0; intervention group coded 1.|Symptoms of depression: standard PHQ-8 composite score.||1.097|-0.571|0.536
71770663|NCT01933789|143041026|SUPERIORITY||Probit regression coefficient|0.208||||0.106|TWO_SIDED|95.0|-0.044|0.461||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Pts clustered under clins. Adjusted for baseline level of the latent depression var; pt age, minority status, education, health status; clin specialty|Control group coded 0; intervention group coded 1.|Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.461|-0.044|0.106
71770664|NCT01933789|143041027|SUPERIORITY||Probit regression coefficient|0.446||||0.343|TWO_SIDED|95.0|-0.476|1.368||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score and clinician specialty.|Control group coded 0; intervention group coded 1.|Symptoms of depression: Standard PHQ-8 composite score||1.368|-0.476|0.343
71830663|NCT01149369|143166327|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.2||||0.28|TWO_SIDED|95.0|-12.0|3.5|||ANCOVA|||||3.5|-12.0|0.28
71830664|NCT01149369|143166328|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.4||||0.47|TWO_SIDED|95.0|-4.1|8.9|||ANCOVA|||||8.9|-4.1|0.47
71726081|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.29|1.59|||||V116/PCV20|Serotype 8: V116/PCV20 GMC Ratio||1.59|1.29|
71726082|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.92|||||V116/PCV20|Serotype 10A: V116/PCV20 GMC Ratio||0.92|0.72|
71830665|NCT01149369|143166329|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.2||||0.68|TWO_SIDED|95.0|-4.5|6.9|||ANCOVA|||||6.9|-4.5|0.68
71830666|NCT01149369|143166330|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.0||||0.48|TWO_SIDED|95.0|-3.6|7.6|||ANCOVA|||||7.6|-3.6|0.48
71830667|NCT01149369|143166331|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.5||||0.43|TWO_SIDED|95.0|-2.2|5.1|||ANCOVA|||||5.1|-2.2|0.43
71830668|NCT01149369|143166332|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.2|||ANCOVA|||||-1.2|-8.5|0.01
71830669|NCT01149369|143166333|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.1|||ANCOVA|||||6.1|-3.4|0.57
71830670|NCT01149369|143166334|NON_INFERIORITY_OR_EQUIVALENCE|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.84||||0.34|TWO_SIDED|95.0|-2.6|1.0|||ANCOVA|||||1.0|-2.6|0.34
71830671|NCT01040689|143166361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.145|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.224|0.145|<0.0001
71726083|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.11|1.36|||||V116/PCV20|Serotype 11A: V116/PCV20 GMC Ratio||1.36|1.11|
71726084|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26|||||V116/PCV20|Serotype 12F: V116/PCV20 GMC Ratio||1.26|0.96|
71726085|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||V116/PCV20|Serotype 19A: V116/PCV20 GMC Ratio||0.77|0.63|
71726086|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9|||||V116/PCV20|Serotype 22F: V116/PCV20 GMC Ratio||0.90|0.72|
71726087|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.95|1.18|||||V116/PCV20|Serotype 33F: V116/PCV20 GMC Ratio||1.18|0.95|
71726088|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|5.41|||||TWO_SIDED|95.0|4.82|6.06|||||V116/PCV20|Serotype 9N: V116/PCV20 GMC Ratio||6.06|4.82|
71770665|NCT01933789|143041028|SUPERIORITY||Probit regression coefficient|-0.034||||0.734|TWO_SIDED|95.0|-0.232|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.232|0.734
71770666|NCT01933789|143041029|SUPERIORITY||Tobit regression coefficient|0.041||||0.935|TWO_SIDED|95.0|-0.946|1.028||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Clustered Tobit regression because strong floor effect on composite score. Adjusted for baseline level of composite score.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Standard GAD-7 composite score||1.028|-0.946|0.935
71770667|NCT01933789|143041030|SUPERIORITY||Probit regression coefficient|-0.042||||0.689|TWO_SIDED|95.0|-0.247|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time||0.163|-0.247|0.689
71830672|NCT01040689|143166361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.167|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.246|0.167|<0.0001
71830673|NCT01040689|143166361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.133|0.212|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.212|0.133|<0.0001
71888329|NCT01482910|143297644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|||<|0.0001|TWO_SIDED|95.0|6.8|13.4||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|ANCOVA|ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (\<45 letters vs ≥45 letters) as fixed factors|Least square mean difference (EYLEA-PDT) was estimated from ANCOVA, where a positive value is in favor of EYLEA.|Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.||13.4|6.8|<0.0001
71726089|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|6.79|||||TWO_SIDED|95.0|6.03|7.64|||||V116/PCV20|Serotype 15A: V116/PCV20 GMC Ratio||7.64|6.03|
71770668|NCT01933789|143041031|SUPERIORITY||Tobit regression coefficient|-0.105||||0.852|TWO_SIDED|95.0|-1.204|0.995||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians. Clustered Tobit regression because of strong floor effect on composite score."|Clustered Tobit regression|Adjusted for baseline level of the GAD-7 composite score.|Control group coded 0; intervention group coded 1.|||0.995|-1.204|0.852
71657931|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71830674|NCT01040689|143166362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.09|0.173|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.173|0.090|<0.0001
71726090|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|2.46|||||TWO_SIDED|95.0|2.17|2.79|||||V116/PCV20|Serotype 15C: V116/PCV20 GMC Ratio||2.79|2.17|
71726091|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|8.75|||||TWO_SIDED|95.0|7.95|9.64|||||V116/PCV20|Serotype 16F: V116/PCV20 GMC Ratio||9.64|7.95|
71726092|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|16.75|||||TWO_SIDED|95.0|15.25|18.41|||||V116/PCV20|Serotype 17F: V116/PCV20 GMC Ratio||18.41|15.25|
71726093|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|12.92|||||TWO_SIDED|5.0|11.81|14.13|||||V116/PCV20|Serotype 20A: V116/PCV20 GMC Ratio||14.13|11.81|
71726094|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|6.42|||||TWO_SIDED|95.0|5.69|7.24|||||V116/PCV20|Serotype 23A: V116/PCV20 GMC Ratio||7.24|5.69|
71726095|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|3.25|||||TWO_SIDED|95.0|2.91|3.64|||||V116/PCV20|Serotype 23B: V116/PCV20 GMC Ratio||3.64|2.91|
71726096|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|21.08|||||TWO_SIDED|85.0|18.97|23.43|||||V116/PCV20|Serotype 24F: V116/PCV20 GMC Ratio||23.43|18.97|
71726097|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|11.31|||||TWO_SIDED|95.0|10.36|12.34|||||V116/PCV20|Serotype 31: V116/PCV20 GMC Ratio||12.34|10.36|
71726098|NCT05425732|142966162|OTHER|cLDA model|GMC Ratio|14.13|||||TWO_SIDED|95.0|12.97|15.4|||||V116/PCV20|Serotype 35B: V116/PCV20 GMC Ratio||15.40|12.97|
71726099|NCT00306293|142966171|SUPERIORITY_OR_OTHER||Percent change from Placebo|-78.0|||<|0.001||95.0|||||Wilcoxon Rank Sum Test||Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo|||||<0.001
71726100|NCT00306293|142966172|SUPERIORITY_OR_OTHER||Percent change from Baseline|-77.0||||0.014||95.0|||||Wilcoxon Rank Sum||Percent change in 'percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo|||||0.014
71726101|NCT01120236|142966184|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.24||||0.16|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA \<= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.||||0.16
71726102|NCT01120236|142966186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.11|TWO_SIDED||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|Proportion of patients in each arm with PSA \> 4 ng/mL after seven cycles of protocol treatment were compared.||||0.11
71726103|NCT04187144|142966195|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the 2.098 Z-statistic boundary.|Adjusted Difference in Percent|14.6|||||TWO_SIDED|95.0|6.4|22.8|||||||Observed Z statistic value for Noninferiority was 5.8838.|22.8|6.4|
71726104|NCT04187144|142966195|SUPERIORITY||Adjusted difference in Percent|14.6||||0.0003|TWO_SIDED|95.0|6.4|22.8|||1-sided p-value for Test of Superiority|||The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.018 p-value boundary||22.8|6.4|0.0003
71726105|NCT02383420|142966240|SUPERIORITY_OR_OTHER|||||||0.415|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 2 sided|||||||0.415
71726106|NCT02383420|142966241|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Level of significance (alpha) = 0.05|t-test, 1 sided|||||||0.0000
71726107|NCT02526524|142966257|SUPERIORITY||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.184||0.1449|TWO_SIDED|95.0|-0.63|0.09|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.09|-0.63|0.1449
71726108|NCT02526524|142966257|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.0643|TWO_SIDED|95.0|-0.69|0.02|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||0.02|-0.69|0.0643
71726109|NCT02526524|142966257|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.0214|TWO_SIDED|95.0|-0.79|-0.06|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.06|-0.79|0.0214
71726110|NCT02526524|142966257|SUPERIORITY||LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.18||0.0022|TWO_SIDED|95.0|-0.91|-0.2|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.20|-0.91|0.0022
71830675|NCT01040689|143166362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.219|0.136|<0.0001
71830676|NCT01040689|143166362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.081|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.164|0.081|<0.0001
71830677|NCT01040689|143166363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.121|0.196|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.196|0.121|<0.0001
71830678|NCT01040689|143166363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.155|0.23|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.230|0.155|<0.0001
71830679|NCT01040689|143166363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.110|<0.0001
71830680|NCT01040689|143166364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.147|0.216|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.216|0.147|<0.0001
71830681|NCT01040689|143166364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.178|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.247|0.178|<0.0001
71830682|NCT01040689|143166364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.097|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.167|0.097|<0.0001
71830683|NCT01040689|143166365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.17|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.243|0.170|<0.0001
71726111|NCT02526524|142966257|SUPERIORITY||LS Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.184|<|0.0001|TWO_SIDED|95.0|-1.39|-0.67|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.||||-0.67|-1.39|<0.0001
71726112|NCT05312632|142966266|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71726113|NCT05312632|142966267|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71726114|NCT05312632|142966268|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71830684|NCT01040689|143166365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.179|0.252|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.252|0.179|<0.0001
71726115|NCT05312632|142966269|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71726116|NCT05312632|142966270|OTHER|||||||0.013|||||||Wilcoxon signed rank test|||||||0.013
71770669|NCT01933789|143041032|SUPERIORITY||probit regression coefficient|-0.221||||0.418|TWO_SIDED|95.0|-0.923|0.482||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient race and health status and by clinician type and specialty|Control group coded 0; intervention group coded 1.|||0.482|-0.923|0.418
71770670|NCT01933789|143041033|SUPERIORITY||probit regression coefficient|0.175||||0.568|TWO_SIDED|95.0|-0.613|0.962||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.962|-0.613|0.568
71770671|NCT01933789|143041034|SUPERIORITY||probit regression coefficient|0.14||||0.592|TWO_SIDED|95.0|-0.534|0.815||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.815|-0.534|0.592
71770672|NCT01933789|143041037|SUPERIORITY||probit regression coefficient|-0.179||||0.705|TWO_SIDED|95.0|-1.398|1.04||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||1.040|-1.398|0.705
71770673|NCT01933789|143041038|SUPERIORITY||probit regression coefficient|0.123||||0.644|TWO_SIDED|95.0|-0.56|0.805||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.|||0.805|-0.560|0.644
71770674|NCT01933789|143041039|SUPERIORITY||probit regression coefficient|-0.165||||0.908|TWO_SIDED|95.0|-3.833|3.503||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient education and health status and by clinician gender.|Control group coded 0; intervention group coded 1.|||3.503|-3.833|0.908
71770675|NCT01933789|143041040|SUPERIORITY||probit regression coefficient|-0.121||||0.552|TWO_SIDED|95.0|-0.646|0.403||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.403|-0.646|0.552
71770676|NCT01933789|143041041|SUPERIORITY||probit regression coefficient|-0.293||||0.372|TWO_SIDED|95.0|-1.139|0.553||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.553|-1.139|0.372
71770677|NCT01933789|143041042|SUPERIORITY||probit regression coefficient|-0.13||||0.501|TWO_SIDED|95.0|-0.63|0.369||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.369|-0.630|0.501
71770678|NCT01933789|143041043|SUPERIORITY||probit regression coefficient|-0.39||||0.192|TWO_SIDED|95.0|-1.16|0.38||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.380|-1.160|0.192
71830685|NCT01040689|143166365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.146|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.219|0.146|<0.0001
71830686|NCT01040689|143166366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.177|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.249|0.177|<0.0001
71726117|NCT05312632|142966271|OTHER|||||||0.053|||||||Wilcoxon signed rank test|||||||0.053
71726118|NCT05312632|142966272|OTHER||||||<|0.001|||||||Wilcoxon signed rank test|||||||<0.001
71726119|NCT02019108|142966274|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.495|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.5|-1.1|0.495
71726120|NCT02019108|142966274|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.079|TWO_SIDED|95.0|-1.6|0.1||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.1|-1.6|0.079
71770679|NCT01933789|143041044|SUPERIORITY||probit regression coefficient|-0.014||||0.94|TWO_SIDED|95.0|-0.489|0.461||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.461|-0.489|0.940
71770680|NCT01933789|143041045|SUPERIORITY||probit regression coefficient|-0.229||||0.47|TWO_SIDED|95.0|-1.044|0.587||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.587|-1.044|0.470
71770681|NCT01933789|143041046|SUPERIORITY||probit regression coefficient|-0.01||||0.955|TWO_SIDED|95.0|-0.474|0.454||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.454|-0.474|0.955
71770682|NCT01933789|143041047|SUPERIORITY||probit regression coefficient|-0.287||||0.303|TWO_SIDED|95.0|-1.005|0.431||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.|||0.431|-1.005|0.303
71726121|NCT02019108|142966275|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.117|TWO_SIDED|95.0|-2.6|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.3|-2.6|0.117
71726122|NCT02019108|142966275|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.133|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.3|-2.5|0.133
71726123|NCT02019108|142966276|SUPERIORITY||Median Difference (Final Values)|-0.14||||0.125|TWO_SIDED|95.0|-0.31|0.04||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks||0.04|-0.31|0.125
71726124|NCT02019108|142966276|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.103|TWO_SIDED|95.0|-0.37|0.03||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks||0.03|-0.37|0.103
71726125|NCT02019108|142966277|SUPERIORITY||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.12||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.12|-0.39|<0.001
71726126|NCT02019108|142966277|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.056|TWO_SIDED|95.0|-0.4|0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.01|-0.40|0.056
71726127|NCT02019108|142966278|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.031|TWO_SIDED|95.0|-0.11|-0.01||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-0.01|-0.11|0.031
71726128|NCT02019108|142966278|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.058|TWO_SIDED|95.0|-0.12|0.0||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.00|-0.12|0.058
71726129|NCT02019108|142966279|SUPERIORITY||Mean Difference (Final Values)|-9.04|||<|0.001|TWO_SIDED|95.0|-11.22|-6.86||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||-6.86|-11.22|<0.001
71770683|NCT01673282|143041069|SUPERIORITY_OR_OTHER||Least Square Mean|-0.24|STANDARD_ERROR_OF_MEAN|0.06|=|0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.||-0.11|-0.36|=0.0003
71770684|NCT03935399|143041070|SUPERIORITY|Exploratory analysis without power calculation||||||0.83|||||||ANOVA|Repeated measures one factor ANOVA||Exploratory analysis without power calculation||||0.83
71830687|NCT01040689|143166366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.203|0.275|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.275|0.203|<0.0001
71726130|NCT02019108|142966279|SUPERIORITY||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.82|-4.75||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||-4.75|-8.82|<0.001
71726131|NCT02019108|142966280|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.111|TWO_SIDED|95.0|-8.3|0.9||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.9|-8.3|0.111
71726132|NCT02019108|142966280|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.232|TWO_SIDED|95.0|-7.3|1.8||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||1.8|-7.3|0.232
71726133|NCT02019108|142966281|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.462|TWO_SIDED|95.0|-0.36|0.78||a priori threshold for significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.78|-0.36|0.462
71726134|NCT02019108|142966281|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.737|TWO_SIDED|95.0|-0.76|0.54||a priori threshold for statistical significance \<0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.54|-0.76|0.737
71726135|NCT02019108|142966282|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.876|TWO_SIDED|95.0|-0.5|0.43||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.||0.43|-0.50|0.876
71726136|NCT02019108|142966282|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.897|TWO_SIDED|95.0|-0.43|0.49||a priori threshold for statistical significance \<0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.||0.49|-0.43|0.897
71770685|NCT03935399|143041071|SUPERIORITY|Exploratory analysis without power calculation||||||0.92|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.92
71770686|NCT03935399|143041072|SUPERIORITY|Exploratory analysis without power calculation||||||0.79|||||||ANOVA|One factor repeated measures ANOVA||Exploratory analysis without power calculation||||0.79
71770687|NCT03935399|143041073|SUPERIORITY|Exploratory analysis without power calculation||||||0.93||||||Exploratory analysis without power calculation|ANOVA|One factor repeated measures ANOVA||||||0.93
71770688|NCT03935399|143041074|SUPERIORITY|Exploratory analysis without power calculation||||||0.89||||||Exploratory analysis without power calculation|ANOVA|Two factor repeated measures ANOVA||||||0.89
71770689|NCT03935399|143041075|SUPERIORITY|Exploratory analysis without power calculation||||||0.83||||||Exploratory analysis without power calculation|ANOVA|Two way repeated measures ANOVA||||||0.83
71726137|NCT01466660|142966313|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.0891|TWO_SIDED|95.0|0.655|1.032||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by Epidermal Growth Factor Receptor (EGFR) mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.032|0.655|0.0891
71726138|NCT01466660|142966314|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0136|TWO_SIDED|95.0|0.595|0.944||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.944|0.595|0.0136
71726139|NCT01466660|142966315|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.862||||0.2343|TWO_SIDED|95.0|0.674|1.101||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.||1.101|0.674|0.2343
71726140|NCT01466660|142966316|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.307||||0.3235|TWO_SIDED|95.0|0.768|2.223||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.223|0.768|0.3235
71726141|NCT01466660|142966319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.138||||0.7856|TWO_SIDED|95.0|0.447|2.896||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.||2.896|0.447|0.7856
71726142|NCT01466660|142966321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.45|STANDARD_ERROR_OF_MEAN|1.87||0.0657|TWO_SIDED|95.0|-7.13|0.23||p-value was not adjusted for multiple comparisons|ANCOVA|Adjusted for baseline sum of diameters, EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|Exploratory trial, no formal hypotheses were tested.||0.23|-7.13|0.0657
71726143|NCT01466660|142966322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.1422|TWO_SIDED|95.0|-0.06|0.01||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|"EQ-5D UK utility score.~Exploratory trial, no formal hypotheses were tested."||0.01|-0.06|0.1422
71726144|NCT01466660|142966322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.054|TWO_SIDED|95.0|-0.06|0.0||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-5D Belgium utility score.~Exploratory trial, no formal hypotheses were tested."||0.00|-0.06|0.0540
71726145|NCT01466660|142966322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.2032|TWO_SIDED|95.0|-3.9|0.8||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-VAS utility score.~Exploratory trial, no formal hypotheses were tested."||0.8|-3.9|0.2032
71726146|NCT00191724|142966324|SUPERIORITY_OR_OTHER|||||||0.528||95.0||||P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6|Regression, Linear|||||||0.528
71726147|NCT00191724|142966324|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90|Regression, Linear|||||||0.230
71726148|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Dyspnea 90-Day Follow-Up.|Regression, Linear|||||||0.018
71726149|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value for Emotional 90 Day Follow-up.|Regression, Linear|||||||0.720
71830688|NCT01040689|143166366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.125|0.197|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.197|0.125|<0.0001
71830689|NCT01040689|143166367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.168|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.258|0.168|<0.0001
71830690|NCT01040689|143166367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.189|0.279|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.279|0.189|<0.0001
71830691|NCT01040689|143166367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.156|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.246|0.156|<0.0001
71830692|NCT01040689|143166368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.096|0.17|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.170|0.096|<0.0001
71830693|NCT01040689|143166368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.11|0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.184|0.110|<0.0001
71830694|NCT01040689|143166368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.06|0.134|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.134|0.060|<0.0001
71726150|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.481||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.481
71888330|NCT01482910|143297645|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.0359|TWO_SIDED|95.0|0.4|12.9||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|Cochran-Mantel-Haenszel|CMH adjusted for baseline BCVA group (\<45 letters vs ≥45 letters)|Proportion difference (EYLEA-PDT) was estimated from CMH, where a positive value is in favor of EYLEA.|Null hypothesis: proportions are identical in both groups||12.9|0.4|0.0359
71726151|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.161
71726152|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.068
71657932|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657933|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657934|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657935|NCT02504671|142831748|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657936|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657937|NCT02504671|142831748|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71657938|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657939|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657940|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657941|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657942|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.6|||7.9|-2.5|
71657943|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657944|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657945|NCT02504671|142831748|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657946|NCT02504671|142831748|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657947|NCT02504671|142831748|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-7.4|7.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.4|-7.4|
71657948|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-6.3|11.7|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||11.7|-6.3|
71657949|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657950|NCT02504671|142831748|OTHER||5.4|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657951|NCT02504671|142831748|OTHER||Difference|2.7|||||TWO_SIDED|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||7.9|-2.5|
71657952|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657953|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71726153|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.985
71726154|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value for Fatigue 90 Day Follow-Up|Regression, Linear|||||||0.281
71726155|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Mastery 90 Day Follow-Up|Regression, Linear|||||||0.273
71726156|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.848
71888331|NCT00110019|143297655|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.863|TWO_SIDED|95.0|0.87|1.18|||Log Rank|Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.18|0.87|0.863
71888332|NCT00110019|143297656|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.092|TWO_SIDED|95.0|0.78|1.03||priori threshold for statistical significance: P\<0.05|Log Rank|Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group|||1.03|0.78|0.092
71888333|NCT00110019|143297657|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||priori threshold for statistical significance: P\<0.05|Fisher Exact|||||||0.427
71888334|NCT04426695|143297662|SUPERIORITY||Least Square (LS) Mean Difference|-0.25||||0.0663|TWO_SIDED|95.0|-0.51|0.02||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.02|-0.51|0.0663
71888335|NCT04426695|143297662|SUPERIORITY||Least Square (LS) Mean Difference|-0.31||||0.0204||95.0|-0.57|0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||||0.05|-0.57|0.0204
71888336|NCT04426695|143297662|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.0172|TWO_SIDED|95.0|-0.51|-0.05||P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.|ANCOVA|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||-0.05|-0.51|0.0172
71888337|NCT04426695|143297663|SUPERIORITY|||||||0.0431||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0431
71888338|NCT04426695|143297663|SUPERIORITY|||||||0.7975||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7975
71888339|NCT04426695|143297663|SUPERIORITY|||||||0.2048||||||P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.2048
71888340|NCT04426695|143297664|SUPERIORITY|||||||0.0039||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0039
71726157|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.841||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.841
71726158|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.797
71726159|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.963
71726160|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear|||||||0.149
71726161|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear|||||||0.141
71726162|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear|||||||0.774
71726163|NCT00191724|142966325|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear|||||||0.394
71726164|NCT02301546|142966327|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71888341|NCT04426695|143297664|SUPERIORITY|||||||0.2415||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2415
71888342|NCT04426695|143297664|SUPERIORITY|||||||0.0195||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0195
71888343|NCT04426695|143297665|SUPERIORITY|||||||0.0085||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0085
71726165|NCT02447250|142966331|OTHER|||||||0.14|||||||Chi-squared|||comparison of mean birth weights between responders and non-responders||||0.14
71726166|NCT02447250|142966332|OTHER|||||||0.16|||||||Chi-squared|||||||0.16
71726167|NCT02447250|142966333|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71726168|NCT02447250|142966335|OTHER|||||||1|||||||Chi-squared|||||||1.0
71726169|NCT02447250|142966336|OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71888344|NCT04426695|143297665|SUPERIORITY|||||||0.9902||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9902
71888345|NCT04426695|143297665|SUPERIORITY|||||||0.1486||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.1486
71888346|NCT04426695|143297666|SUPERIORITY|||||||0.0092||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
71726170|NCT01885208|142966345|NON_INFERIORITY|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
71726171|NCT01885208|142966345|SUPERIORITY|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).|Treatment difference|-0.62|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-0.44|-0.8|< 0.0001
71726172|NCT01709422|142966351|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.05||95.0|||||Chi-squared|||||||0.05
71726173|NCT01709422|142966352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.05
71726174|NCT00396006|142966375|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0195|||||||Wilcoxon signed rank test|||||||0.0195
71726175|NCT00396006|142966379|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
71770690|NCT03935399|143041076|SUPERIORITY|Exploratory analysis without power caclulation||||||0.57||||||Exploratory analysis without power caclulation|ANOVA|Two way repeated measures ANOVA||||||0.57
71726176|NCT00396006|142966380|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||paired t-tests|||||||<0.0001
71726177|NCT00396006|142966382|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1875|||||||Wilcoxon signed rank test|||||||0.1875
71726178|NCT00396006|142966383|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4375|||||||Wilcoxon signed rank|||||||0.4375
71726179|NCT01972308|142966387|SUPERIORITY||Group differences in expected 12 month c|-0.31|||||TWO_SIDED|95.0|-0.64|0.04||||||||0.04|-0.64|
71726180|NCT01972308|142966388|SUPERIORITY||Group differences in expected 12 month c|-0.66|||||TWO_SIDED|95.0|-1.38|-0.01||||||||-0.01|-1.38|
71726181|NCT01972308|142966389|SUPERIORITY||Group differences in expected 12 month c|0.06|||||TWO_SIDED|95.0|-0.33|0.43||||||||0.43|-0.33|
71726182|NCT01972308|142966390|SUPERIORITY||Group differences in expected 12 month c|0.02|||||TWO_SIDED|95.0|-0.42|0.48||||||||0.48|-0.42|
71726183|NCT01972308|142966391|SUPERIORITY||Group differences in expected 12 month c|0.04|||||TWO_SIDED|95.0|-0.1|0.19||||||||0.19|-0.10|
71726184|NCT01972308|142966392|SUPERIORITY||Group differences in expected 12 month c|0.12|||||TWO_SIDED|95.0|-0.24|0.6||||||||0.60|-0.24|
71726185|NCT05898672|142966423|OTHER||Ratio of adjusted geometric means|131.18|||||TWO_SIDED|90.0|115.89|148.48||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||148.48|115.89|
71726186|NCT05898672|142966424|OTHER||Ratio of adjusted geometric means|212.44|||||TWO_SIDED|90.0|174.31|258.9||||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant within sequence as a random effect. Ratio of adjusted geometric means of test to reference was reported; where test treatment is Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg and reference treatment is Rosuvastatin 10 mg. Ratio and associated 90% CIs were reported in percentage.||258.90|174.31|
71726187|NCT04730635|142966493|OTHER||Posterior Probability|46.3||||||||||||||There was a threshold of ≥2 percentage points. A posterior probability value \>55% was required to satisfy the primary hypothesis.||||
71726188|NCT04730635|142966494|OTHER||Posterior Probability|80.67||||||||||||||There was a threshold of ≤ 0.1 for this standard deviation change. A posterior probability value \>70% was required to satisfy this secondary hypothesis.||||
71726189|NCT04730635|142966495|OTHER||Posterior Probability|98.8||||||||||||||||||
71726190|NCT01974206|142966513|OTHER||Common Odds Ratio|0.79||||0.307|TWO_SIDED|90.0|0.43|1.47||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization strata, and the 90% CIs of the CMH odds ratio stratified by randomization group.||1.47|0.43|0.307
71726191|NCT01974206|142966514|OTHER||Common Odds Ratio|0.99||||0.576|TWO_SIDED|90.0|0.46|2.15||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||2.15|0.46|0.576
71770691|NCT01112683|143041077|SUPERIORITY_OR_OTHER|||||||0.403|ONE_SIDED|90.0|||||Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||20 subjects per group were expected to provide 60% power to detect a between-group mean difference of 1.2 correct patterns (change from baseline to week 16) on the Paired Associates Learning and to provide 40% power to detect a between-group mean difference of 1.2 patterns recognized on the Pattern Recognition Memory. A two-sided test at type I error rate of 5% was used. Sample size incorporated an inflation factor of 20% to account for ineligibility of 10% of randomized participants.||||0.403
71770692|NCT01112683|143041078|SUPERIORITY_OR_OTHER|||||||0.371|ONE_SIDED|90.0||||This P-Value refers to the SIB-R Broad independence score.|Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||No power calculations were performed for the secondary measures.||||0.371
71770693|NCT02635646|143041119|OTHER|T test for mean comparisons between independent groups||||||0.844||||||Significant p value less than 0.05|t-test, 2 sided|||||||0.844
71770694|NCT02635646|143041120|OTHER|||||||0.624|||||||t-test, 2 sided|||||||0.624
71770695|NCT02635646|143041121|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71770696|NCT02635646|143041122|OTHER|||||||0.516|||||||t-test, 2 sided|||||||0.516
71770697|NCT02635646|143041123|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71770698|NCT00400153|143041128|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liter|Mean Difference (Final Values)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0095||0.7135||95.0|-0.0222|0.0152|||ANCOVA|||||0.0152|-0.0222|0.7135
71888347|NCT04426695|143297666|SUPERIORITY|||||||0.221||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2210
71726192|NCT01974206|142966515|OTHER||Common Odds Ratio|0.88||||0.408|TWO_SIDED|90.0|0.48|1.59||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.59|0.48|0.408
71726193|NCT01974206|142966516|OTHER||Common Odds Ratio|0.88||||0.419|TWO_SIDED|90.0|0.48|1.61||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||The exact Cochran-Mantel-Haenszel (CMH) estimate of the common odds ratio (ASP0113 vs placebo) stratified by randomization group, and the 90% CI of the exact CMH odds ratio stratified by randomization group.||1.61|0.48|0.419
71726194|NCT01974206|142966517|OTHER|||||||0.5||||||P-value (1-sided) of the Exact Cochran-Mantel-Haenszel method adjusted odds ratio stratified by randomization group.|Cochran-Mantel-Haenszel|||Exact Cochran-Mantel-Haenszel estimate of the common odds ratio could not be calculated as 100% of ASP0113 group showed graft survival, and this leads to having a value of 0 for the denominator for the ratio thus odds ratio is not estimable. The 90% CI (2-sided) values for the odds ratio are 0.11 to NA, where NA is an infinity value.||||0.5
71726195|NCT03219034|142966531|SUPERIORITY||Median Difference (Final Values)|3.8||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cross-over design: Median differences between oral appliances at the end of the first 4-week leg of the study (T2). The hypothesis tested was that REI would be lowered more with Appliance A than B.||||0.152
71726196|NCT02438683|142966533|OTHER||Slope|0.0029|||||TWO_SIDED|95.0|0.0012|0.0046||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected HR change from baseline (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis).||0.0046|0.0012|
71726197|NCT02438683|142966534|OTHER||Mean Difference (Net)|3.85|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|90.0|0.73|6.97||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||6.97|0.73|
71726198|NCT02438683|142966535|OTHER||Mean Difference (Net)|4.93|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|1.69|8.16||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.16|1.69|
71770699|NCT00400153|143041129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.028|0.066|||ANCOVA|||||0.066|0.028|< 0.0001
71770700|NCT00400153|143041130|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 0.05 liters|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.011||0.1389||95.0|-0.039|0.005|||ANCOVA|||||0.005|-0.039|0.1389
71770701|NCT00400153|143041131|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.124||95.0|-0.036|0.004|||ANCOVA|||||0.004|-0.036|0.124
71770702|NCT00400153|143041132|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.4888||95.0|-0.026|0.013|||ANCOVA|||||0.013|-0.026|0.4888
71657954|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71770703|NCT00400153|143041133|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.014||||0.1433||95.0|-0.033|0.005|||ANCOVA|||||0.005|-0.033|0.1433
71770704|NCT00400153|143041134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.083|||ANCOVA|||This analysis is purely exploratory.||0.083|0.04|< 0.0001
71770705|NCT00400153|143041135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.024|0.065|||ANCOVA|||This analysis is purely exploratory.||0.065|0.024|< 0.0001
71770706|NCT00400153|143041136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001||95.0|0.027|0.067|||ANCOVA|||This analysis is purely exploratory.||0.067|0.027|< 0.0001
71770707|NCT00400153|143041137|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0258||95.0|0.003|0.049|||ANCOVA|||||0.049|0.003|0.0258
71770708|NCT00400153|143041138|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.011||0.3749||95.0|-0.032|0.012|||ANCOVA|||||0.012|-0.032|0.3749
71770709|NCT00400153|143041139|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.3355||95.0|-0.033|0.011|||ANCOVA|||||0.011|-0.033|0.3355
71770710|NCT00400153|143041140|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.0743||95.0|-0.042|0.002|||ANCOVA|||||0.002|-0.042|0.0743
71770711|NCT00400153|143041141|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.011||0.5711||95.0|-0.015|0.028|||ANCOVA|||||0.028|-0.015|0.5711
71888348|NCT04426695|143297666|SUPERIORITY|||||||0.0249||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0249
71888349|NCT04426695|143297667|SUPERIORITY|||||||0.0045||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0045
71888350|NCT04426695|143297667|SUPERIORITY|||||||0.0714||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0714
71888351|NCT04426695|143297667|SUPERIORITY|||||||0.0061||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0061
71888352|NCT04426695|143297668|SUPERIORITY|||||||0.0023||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0023
71888353|NCT04426695|143297668|SUPERIORITY|||||||0.3544||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3544
71888354|NCT04426695|143297668|SUPERIORITY|||||||0.0212||||||P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< = 5 or n(1-p) \<= 5 in any treatment group, p-value was based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.||||0.0212
71726199|NCT02438683|142966536|OTHER||Slope|0.0011|||||TWO_SIDED|95.0|-0.0009|0.003||||The covariance structure is No diagonal Factor Analytic FA0(2).||The regression model with response variable placebo-corrected QTcF change from baseline (ddQTcF) and independent variable. Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject (Primary analysis). The covariance structure is No diagonal Factor Analytic FA0(2).||0.0030|-0.0009|
71770712|NCT00400153|143041142|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.011||0.2274||95.0|-0.033|0.008|||ANCOVA|||||0.008|-0.033|0.2274
71888355|NCT04426695|143297674|SUPERIORITY|||||||0.0575||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0575
71888356|NCT04426695|143297674|SUPERIORITY|||||||0.3133||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3133
71888357|NCT04426695|143297674|SUPERIORITY|||||||0.0849||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0849
71657955|NCT02504671|142831748|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71770713|NCT00400153|143041143|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8065||95.0|-0.018|0.024|||ANCOVA|||||0.024|-0.018|0.8065
71770714|NCT00400153|143041144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.043|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.043|< 0.0001
71770715|NCT00400153|143041145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.044|0.087|||ANCOVA|||This analysis is purely exploratory.||0.087|0.044|< 0.0001
71770716|NCT00400153|143041146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.04|0.081|||ANCOVA|||This analysis is purely exploratory.||0.081|0.04|< 0.0001
71770717|NCT00400153|143041147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.047|0.089|||ANCOVA|||This analysis is purely exploratory.||0.089|0.047|< 0.0001
71770718|NCT00400153|143041160|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.021||0.417||95.0|-0.058|0.024|||ANCOVA|||||0.024|-0.058|0.417
71770719|NCT00400153|143041161|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3505||95.0|-0.059|0.021|||ANCOVA|||||0.021|-0.059|0.3505
71770720|NCT00400153|143041162|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02||0.3499||95.0|-0.058|0.021|||ANCOVA|||||0.021|-0.058|0.3499
71770721|NCT00400153|143041163|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.8288||95.0|-0.044|0.035|||ANCOVA|||||0.035|-0.044|0.8288
71770722|NCT00400153|143041164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.069|0.154|||ANCOVA|||This analysis is purely exploratory.||0.154|0.069|< 0.0001
71770723|NCT00400153|143041165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.049|0.132|||ANCOVA|||This analysis is purely exploratory.||0.132|0.049|< 0.0001
71770724|NCT00400153|143041166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.056|0.138|||ANCOVA|||This analysis is purely exploratory.||0.138|0.056|< 0.0001
71770725|NCT00400153|143041167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.054|0.135|||ANCOVA|||This analysis is purely exploratory.||0.135|0.054|< 0.0001
71770726|NCT00400153|143041168|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.024||0.0688||95.0|-0.003|0.09|||ANCOVA|||||0.09|-0.003|0.0688
71770727|NCT00400153|143041169|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.023||0.3895||95.0|-0.064|0.025|||ANCOVA|||||0.025|-0.064|0.3895
71770728|NCT00400153|143041170|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.022||0.959||95.0|-0.045|0.042|||ANCOVA|||||0.042|-0.045|0.959
71770729|NCT00400153|143041171|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.023||0.7652||95.0|-0.053|0.039|||ANCOVA|||||0.039|-0.053|0.7652
71770730|NCT00400153|143041172|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.023||0.6244||95.0|-0.057|0.034|||ANCOVA|||||0.034|-0.057|0.6244
71770731|NCT00400153|143041173|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.023||0.873||95.0|-0.041|0.049|||ANCOVA|||||0.049|-0.041|0.873
71770732|NCT00400153|143041174|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.023||0.5294||95.0|-0.06|0.031|||ANCOVA|||||0.031|-0.06|0.5294
71770733|NCT00400153|143041175|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.023||0.563||95.0|-0.032|0.058|||ANCOVA|||||0.058|-0.032|0.563
71770734|NCT00400153|143041176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.075|0.167|||ANCOVA|||This analysis is purely exploratory.||0.167|0.075|< 0.0001
71770735|NCT00400153|143041177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.084|0.174|||ANCOVA|||This analysis is purely exploratory.||0.174|0.084|< 0.0001
71830695|NCT01040689|143166369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.216|0.348|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.348|0.216|<0.0001
71830696|NCT01040689|143166369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.237|0.368|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.368|0.237|<0.0001
71830697|NCT01040689|143166369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.21|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.342|0.210|<0.0001
71830698|NCT01040689|143166370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.131|0.262|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.262|0.131|<0.0001
71830699|NCT01040689|143166370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.187|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.318|0.187|<0.0001
71830700|NCT01040689|143166370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.118|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.249|0.118|<0.0001
71830701|NCT01040689|143166371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.178|0.301|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.301|0.178|<0.0001
71830702|NCT01040689|143166371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.216|0.339|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.339|0.216|<0.0001
71830703|NCT01040689|143166371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.168|0.291|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.291|0.168|<0.0001
71830704|NCT01040689|143166372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.207|0.33|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.330|0.207|<0.0001
71830705|NCT01040689|143166372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.251|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.374|0.251|<0.0001
71830706|NCT01040689|143166372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.153|0.277|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.277|0.153|<0.0001
71726200|NCT02438683|142966537|OTHER||Mean Difference (Net)|4.54|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|3.39|5.7||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||5.70|3.39|
71726201|NCT02438683|142966538|OTHER||Mean Difference (Net)|4.73|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|90.0|1.34|8.13||||For the repeated effect 'time', the covariance structure was chosen to be unstructured.|Mean Difference (Net) is actually the adjusted mean difference calculated as BI 409306 200 mg minus Placebo.|The a repeated measures model included 'period baseline', 'subject baseline' (defined as the arithmetic mean of the 2 period baselines), 'treatment', 'baseline\*time' interaction, 'treatment\*time' interaction and 'time' as fixed effects and subject as random effect (Primary analysis).||8.13|1.34|
71726202|NCT02438683|142966539|OTHER||Slope|0.0054|||||TWO_SIDED|95.0|0.0032|0.0076||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected max HR (dHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept and slope estimates for each subject. (Primary analysis)||0.0076|0.0032|
71726203|NCT02438683|142966540|OTHER||Slope|-0.0014|||||TWO_SIDED|95.0|-0.0036|0.0008||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||0.0008|-0.0036|
71726204|NCT02438683|142966540|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0029|||||TWO_SIDED|95.0|-0.0052|-0.0007||||The covariance structure is Unstructured.||The regression model with response variable placebo-corrected change from max HR to recovery HR (ddHR) and independent variable Plasma concentration includes a fixed slope effect as well as random intercept estimates for each subject (Primary analysis).||-0.0007|-0.0052|
71726205|NCT05463744|142966605|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.052|||||TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|
71726206|NCT05463744|142966606|SUPERIORITY||LS Mean Difference|0.052||||0.432|TWO_SIDED|95.0|-0.077|0.181|||ANCOVA|||||0.181|-0.077|0.432
71726207|NCT05463744|142966607|SUPERIORITY||LS Mean Difference|-0.31||||0.751|TWO_SIDED|95.0|-2.22|1.6|||ANCOVA|||||1.60|-2.22|0.751
71726208|NCT05463744|142966608|SUPERIORITY||Relative Rate|1.02||||0.9|TWO_SIDED|95.0|0.79|1.31|||Negative binomial model|||||1.31|0.79|0.900
71726209|NCT05463744|142966609|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0682|||TWO_SIDED|95.0|-0.11|0.157|||ANCOVA|||||0.157|-0.110|
71726210|NCT05463744|142966610|SUPERIORITY||LS Mean Difference|-1.22||||0.697|TWO_SIDED|95.0|-7.38|4.93|||ANCOVA|||Week 26||4.93|-7.38|0.697
71726211|NCT05463744|142966610|SUPERIORITY||LS Mean Difference|-4.84||||0.163|TWO_SIDED|95.0|-11.64|1.96|||ANCOVA|||Week 52||1.96|-11.64|0.163
71726212|NCT05463744|142966611|SUPERIORITY||LS Mean Difference|0.02||||0.939|TWO_SIDED|95.0|-0.61|0.66|||Mixed Models Analysis|||Week 23 to Week 26||0.66|-0.61|0.939
71726213|NCT05463744|142966611|SUPERIORITY||LS Mean Difference|0.52||||0.116|TWO_SIDED|95.0|-0.13|1.17|||Mixed Models Analysis|||Week 49 to Week 52||1.17|-0.13|0.116
71726214|NCT05463744|142966612|SUPERIORITY||LS Mean Difference|0.54||||0.61|TWO_SIDED|95.0|-1.54|2.62|||ANCOVA|||||2.62|-1.54|0.610
71726215|NCT05463744|142966613|SUPERIORITY||LS Mean Difference|-8.96||||0.155|TWO_SIDED|95.0|-21.3|3.38|||Mixed Models Analysis|||Week 26||3.38|-21.30|0.155
71726216|NCT05463744|142966613|SUPERIORITY||LS Mean Difference|-6.88||||0.278|TWO_SIDED|95.0|-19.31|5.55|||Mixed Models Analysis|||Week 52||5.55|-19.31|0.278
71726217|NCT05463744|142966614|SUPERIORITY||LS Mean Difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.52|-2.03|||Mixed Models Analysis|||Week 26||-2.03|-5.52|<0.001
71770736|NCT00400153|143041178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.072|0.163|||ANCOVA|||This analysis is purely exploratory.||0.163|0.072|< 0.0001
71726218|NCT05463744|142966614|SUPERIORITY||LS Mean Difference|-3.49|||<|0.001|TWO_SIDED|95.0|-5.26|-1.71|||Mixed Models Analysis|||Week 52||-1.71|-5.26|<0.001
71726219|NCT05463744|142966615|SUPERIORITY||LS Mean Difference|-39.28|||<|0.001|TWO_SIDED|95.0|-57.59|-20.98|||Mixed Models Analysis|||Week 26||-20.98|-57.59|<0.001
71726220|NCT05463744|142966615|SUPERIORITY||LS Mean Difference|-35.94|||<|0.001|TWO_SIDED|95.0|-54.44|-17.43|||Mixed Models Analysis|||Week 52||-17.43|-54.44|<0.001
71726221|NCT05463744|142966616|SUPERIORITY||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|1.32|5.06|||Mixed Models Analysis|||Week 26||5.06|1.32|<0.001
71726222|NCT05463744|142966616|SUPERIORITY||LS Mean Difference|2.8||||0.004|TWO_SIDED|95.0|0.91|4.7|||Mixed Models Analysis|||Week 52||4.70|0.91|0.004
71726223|NCT05463744|142966617|SUPERIORITY||Relative Rate|1.21||||0.016|TWO_SIDED|95.0|1.04|1.41|||Negative binomial model|||||1.41|1.04|0.016
71726224|NCT05463744|142966618|SUPERIORITY||LS Mean Difference|0.086||||0.702|TWO_SIDED|95.0|-0.35|0.53|||Mixed Models Analysis|||Week 26||0.53|-0.35|0.702
71726225|NCT05463744|142966618|SUPERIORITY||LS Mean Difference|0.12||||0.609|TWO_SIDED|95.0|-0.33|0.56|||Mixed Models Analysis|||Week 52||0.56|-0.33|0.609
71726226|NCT05463744|142966619|SUPERIORITY||LS Mean Difference|0.03||||0.681|TWO_SIDED|95.0|-0.13|0.19|||ANCOVA|||Week 23 to Week 26||0.19|-0.13|0.681
71726227|NCT05463744|142966619|SUPERIORITY||LS Mean Difference|0.1||||0.182|TWO_SIDED|95.0|-0.05|0.24|||ANCOVA|||Week 49 to Week 52||0.24|-0.05|0.182
71726228|NCT05463744|142966620|SUPERIORITY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-2.06|2.05|||ANCOVA|||Week 23 to Week 26||2.05|-2.06|0.999
71726229|NCT05463744|142966621|SUPERIORITY||LS Mean Difference|-0.83||||0.468|TWO_SIDED|95.0|-3.06|1.41|||ANCOVA|||||1.41|-3.06|0.468
71770737|NCT00400153|143041179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.171|||ANCOVA|||This analysis is purely exploratory.||0.171|0.081|< 0.0001
71770738|NCT00400153|143041184|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.00045|STANDARD_ERROR_OF_MEAN|0.06396||0.9943||95.0|-0.1259|0.125|||ANCOVA|||||0.125|-0.1259|0.9943
71770739|NCT00400153|143041184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01995|STANDARD_ERROR_OF_MEAN|0.06441||0.7569|TWO_SIDED|95.0|-0.1463|0.1064|||ANCOVA|||This analysis is purely exploratory.||0.1064|-0.1463|0.7569
71726230|NCT05463744|142966622|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71770740|NCT00400153|143041185|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.1091|STANDARD_ERROR_OF_MEAN|0.1206||0.3659||95.0|-0.1276|0.3458|||ANCOVA|||||0.3458|-0.1276|0.3659
71770741|NCT00400153|143041185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1554|STANDARD_ERROR_OF_MEAN|0.122||0.203|TWO_SIDED|95.0|-0.3947|0.08395|||ANCOVA|||This analysis is purely exploratory.||0.08395|-0.3947|0.203
71830707|NCT01040689|143166373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.246|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.388|0.246|<0.0001
71830708|NCT01040689|143166373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.247|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.388|0.247|<0.0001
71830709|NCT01040689|143166373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.231|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.231|<0.0001
71830710|NCT01040689|143166374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.222|0.378|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.378|0.222|<0.0001
71830711|NCT01040689|143166374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.22|0.375|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.375|0.220|<0.0001
71830712|NCT01040689|143166374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.217|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.373|0.217|<0.0001
71830713|NCT01040689|143166375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.115|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.255|0.115|<0.0001
71830714|NCT01040689|143166375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.143|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.143|<0.0001
71830715|NCT01040689|143166375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.036||0.0003||95.0|0.059|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.059|0.0003
71830716|NCT01185561|143166377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.89|STANDARD_ERROR_OF_MEAN|2.43||0.001|TWO_SIDED|95.0|4.03|13.76|||t-test, 2 sided|||The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||13.76|4.03|.001
71888358|NCT04426695|143297675|SUPERIORITY|||||||0.2167||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2167
71726231|NCT05463744|142966623|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71830717|NCT01185561|143166378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|STANDARD_ERROR_OF_MEAN|3.27||0.02|TWO_SIDED|95.0|1.29|14.37|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.37|1.29|.02
71830718|NCT01185561|143166379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|2.91||0.005|TWO_SIDED|95.0|2.64|14.31|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||14.31|2.64|.005
71830719|NCT01185561|143166380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|3.75||0.85|TWO_SIDED|95.0|-6.77|8.24|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.||8.24|-6.77|.85
71726232|NCT05463744|142966624|SUPERIORITY||LS Mean Difference|0.43||||0.27|TWO_SIDED|95.0|-0.33|1.19|||Mixed Models Analysis|||Physical Component Score: Week 26||1.19|-0.33|0.270
71726233|NCT05463744|142966624|SUPERIORITY||LS Mean Difference|0.73||||0.05|TWO_SIDED|95.0|0.0|1.45|||Mixed Models Analysis|||Physical Component Score: Week 52||1.45|0.000|0.050
71726234|NCT05463744|142966624|SUPERIORITY||LS Mean Difference|0.22||||0.71|TWO_SIDED|95.0|-0.94|1.38|||Mixed Models Analysis|||Mental Component Score: Week 26||1.38|-0.94|0.710
71770742|NCT00400153|143041186|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.007734|STANDARD_ERROR_OF_MEAN|0.03199||0.809||95.0|-0.05503|0.0705|||ANCOVA|||||0.0705|-0.05503|0.809
71770743|NCT00400153|143041186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06501|STANDARD_ERROR_OF_MEAN|0.03225||0.044|TWO_SIDED|95.0|0.001746|0.1283|||ANCOVA|||This analysis is purely exploratory.||0.1283|0.001746|0.044
71770744|NCT00400153|143041187|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.0129|STANDARD_ERROR_OF_MEAN|0.03002||0.6674||95.0|-0.04598|0.07179|||ANCOVA|||||0.07179|-0.04598|0.6674
71726235|NCT05463744|142966624|SUPERIORITY||LS Mean Difference|0.45||||0.447|TWO_SIDED|95.0|-0.71|1.61|||Mixed Models Analysis|||Mental Component Score: Week 52||1.61|-0.71|0.447
71726236|NCT01579565|142966632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.049||0.0001||95.0|0.494|0.686||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||0.686|0.494|0.0001
71726237|NCT01579565|142966633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58|STANDARD_ERROR_OF_MEAN|1.192||0.0002||95.0|-6.917|-2.244||p-value is based on the generalized CMH test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 - Placebo) is adjusted for the randomization strata.||||-2.244|-6.917|0.0002
71726238|NCT01579565|142966634|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test.|Chi-squared|||||||0.0001
71726239|NCT01579565|142966635|SUPERIORITY_OR_OTHER|||||||0.0001||||||Chi-square test|Chi-squared|||||||0.0001
71726240|NCT01579565|142966636|SUPERIORITY_OR_OTHER|||||||0.076||||||Chi-square test|Chi-squared|||||||0.0760
71726241|NCT01579565|142966637|SUPERIORITY_OR_OTHER|||||||0.0806||||||Chi-square test|Chi-squared|||||||0.0806
71726242|NCT01579565|142966638|SUPERIORITY_OR_OTHER|||||||0.0002||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.0002
71726243|NCT01579565|142966639|SUPERIORITY_OR_OTHER|||||||0.3923||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3923
71726244|NCT01579565|142966640|SUPERIORITY_OR_OTHER|||||||0.006||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.0060
71726245|NCT01579565|142966641|SUPERIORITY_OR_OTHER|||||||0.3286||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|||||||0.3286
71726246|NCT01579565|142966642|SUPERIORITY_OR_OTHER|||||||0.2361||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata.|Wilcoxon rank-sum test|||||||0.2361
71726247|NCT01448824|142966648|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS Means|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
71726248|NCT01448824|142966649|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon signed rank|||||0.50|-0.50|1.0000
71726249|NCT01448824|142966650|NON_INFERIORITY_OR_EQUIVALENCE|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of \~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS means|2.37|||||TWO_SIDED|90.0|1.77|3.18||||||||3.18|1.77|
71726250|NCT03817463|142966660|OTHER||Adjusted Hazard Ratio|0.7|||<|0.005|TWO_SIDED|95.0|0.6|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-(broad+specific)||0.83|0.60|<0.005
71726251|NCT03817463|142966660|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.57|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline||HHF-(broad + specific).||0.78|0.57|<0.005
71726252|NCT03817463|142966661|OTHER||Ajusted hazard ratio|0.75|||<|0.005|TWO_SIDED|95.0|0.69|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.81|0.69|<0.005
71726253|NCT03817463|142966661|OTHER||Ajusted hazard ratio|0.78|||<|0.005|TWO_SIDED|95.0|0.69|0.88|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-broad.||0.88|0.69|<0.005
71726254|NCT03817463|142966662|OTHER||Adjusted Hazard Ratio|0.68|||<|0.005|TWO_SIDED|95.0|0.56|0.83|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.83|0.56|<0.005
71726255|NCT03817463|142966662|OTHER||Adjusted Hazard Ratio|0.64|||<|0.005|TWO_SIDED|95.0|0.51|0.81|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||HHF-specific. Hazards ratios reported include data from all countries with non-missing values.||0.81|0.51|<0.005
71726256|NCT03817463|142966663|OTHER||Adjusted Hazard Ratio|0.55|||<|0.005|TWO_SIDED|95.0|0.48|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.63|0.48|<0.005
71726257|NCT03817463|142966663|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.54|0.65|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.65|0.54|<0.005
71726258|NCT03817463|142966664|OTHER||Adjusted Hazard Ratio|0.65|||<|0.05|TWO_SIDED|95.0|0.56|0.76|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.76|0.56|<0.05
71726259|NCT03817463|142966664|OTHER||Adjusted Hazard Ratio|0.66|||<|0.005|TWO_SIDED|95.0|0.61|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.72|0.61|<0.005
71726260|NCT03817463|142966665|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.64|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.82|0.64|<0.005
71726261|NCT03817463|142966665|OTHER||Adjusted Hazard Ratio|0.72|||<|0.005|TWO_SIDED|95.0|0.66|0.78|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.78|0.66|<0.005
71888359|NCT04426695|143297675|SUPERIORITY|||||||0.4123||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4123
71726262|NCT03817463|142966666|OTHER||Adjusted Hazard Ratio|1.02||||0.816|TWO_SIDED|95.0|0.88|1.18|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.18|0.88|0.816
71657956|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71726263|NCT03817463|142966666|OTHER||Adjusted Hazard Ratio|0.87||||0.013|TWO_SIDED|95.0|0.78|0.97|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.97|0.78|0.013
71726264|NCT03817463|142966667|OTHER||Adjusted Hazard Ratio|0.82|||<|0.011|TWO_SIDED|95.0|0.71|0.96|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.96|0.71|<0.011
71726265|NCT03817463|142966667|OTHER||Adjusted Hazard Ratio|0.84||||0.064|TWO_SIDED|95.0|0.69|1.01|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.01|0.69|0.064
71726266|NCT03817463|142966668|OTHER||Adjusted Hazard Ratio|0.59|||<|0.005|TWO_SIDED|95.0|0.42|0.84|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.84|0.42|<0.005
71726267|NCT03817463|142966668|OTHER||Adjusted Hazard Ratio|0.6|||<|0.005|TWO_SIDED|95.0|0.49|0.72|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.72|0.49|<0.005
71726268|NCT03817463|142966669|OTHER||Adjusted Hazard Ratio|0.54|||<|0.005|TWO_SIDED|95.0|0.46|0.64|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.64|0.46|<0.005
71726269|NCT03817463|142966669|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.47|0.66|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.66|0.47|<0.005
71726270|NCT03817463|142966670|OTHER||Adjusted Hazard Ratio|0.95||||0.545|TWO_SIDED|95.0|0.81|1.11|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.11|0.81|0.545
71726271|NCT03817463|142966670|OTHER||Adjusted Hazard Ratio|0.91||||0.036|TWO_SIDED|95.0|0.83|0.99|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||0.99|0.83|0.036
71726272|NCT03817463|142966671|OTHER||Adjusted Hazard Ratio|0.93||||0.353|TWO_SIDED|95.0|0.79|1.09|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.09|0.79|0.353
71770745|NCT00400153|143041187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01573|STANDARD_ERROR_OF_MEAN|0.03033||0.604|TWO_SIDED|95.0|-0.04376|0.07523|||ANCOVA|||This analysis is purely exploratory.||0.07523|-0.04376|0.604
71726273|NCT03817463|142966671|OTHER||Adjusted Hazard Ratio|0.9||||0.197|TWO_SIDED|95.0|0.78|1.05|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.05|0.78|0.197
71726274|NCT03817463|142966672|OTHER||Adjusted Hazard Ratio|0.43|||<|0.005|TWO_SIDED|95.0|0.3|0.63|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.63|0.30|<0.005
71830720|NCT01599793|143166415|EQUIVALENCE|Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)||||||0.0016|||||||Mixed Models Analysis|||The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.||||0.0016
71830721|NCT01599793|143166417|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.36853||||0.3291|TWO_SIDED||||||t-test, 2 sided|||||||0.3291
71830722|NCT01599793|143166419|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0|Spearman Correlation Coefficients|-0.41818||||0.2006|TWO_SIDED||||||t-test, 2 sided|||||||0.2006
71830723|NCT01599793|143166421|OTHER|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.17669||||0.5828|TWO_SIDED||||||t-test, 2 sided|||||||0.5828
71830724|NCT02594735|143166450|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71830725|NCT02594735|143166451|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71830726|NCT02594735|143166452|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
71830727|NCT02594735|143166453|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71830728|NCT02594735|143166454|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71830729|NCT02594735|143166455|OTHER|||||||0.375|||||||t-test, 2 sided|||||||0.375
71830730|NCT02594735|143166456|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71830731|NCT02594735|143166457|OTHER|||||||0.044|||||||Sign test|Data was not normally distributed||||||0.044
71830732|NCT02594735|143166458|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71830733|NCT00475319|143166482|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
71830734|NCT00475319|143166483|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||versus placebo|t-test, 2 sided|a general linear model||||||0.001
71830735|NCT01075217|143166484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|2.45|<|0.0001|TWO_SIDED|95.0|1.4|3.5||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 1, i.e., pain was not assessed separately from heat.|t-test, 2 sided|||||3.5|1.4|<0.0001
71830736|NCT01075217|143166484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|1.94||0.3244|TWO_SIDED|95.0|-0.5|1.4||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 2, i.e., pain was assessed separately from heat.|t-test, 2 sided|||||1.4|-0.5|0.3244
71830737|NCT01075217|143166485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.35||0.0059|TWO_SIDED|95.0|0.5|2.7|||t-test, 2 sided|||||2.7|0.5|0.0059
71830738|NCT00364013|143166517|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.27||||0.0234||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.||||0.0234
71657957|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71830739|NCT00364013|143166517|SUPERIORITY_OR_OTHER_LEGACY||Normal score|2.28||||0.0227||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0227
71830740|NCT00364013|143166518|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.8||||0.0723||||||cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.0723
71830741|NCT00364013|143166518|SUPERIORITY_OR_OTHER_LEGACY||Normal score|1.83||||0.0678||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score \<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.||||0.0678
71830742|NCT00364013|143166519|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.0684|TWO_SIDED|95.0|0.98|1.87|||Stratified exact test|Adjusted for geographic region and ECOG score.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.87|0.98|0.0684
71888360|NCT04426695|143297675|SUPERIORITY|||||||0.2206||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2206
71726275|NCT03817463|142966672|OTHER||Adjusted Hazard Ratio|0.27|||<|0.005|TWO_SIDED|95.0|0.16|0.44|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.44|0.16|<0.005
71726276|NCT03817463|142966673|OTHER||Adjusted Hazard Ratio|1.05||||0.535|TWO_SIDED|95.0|0.89|1.25|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.25|0.89|0.535
71726277|NCT03817463|142966673|OTHER||Adjusted Hazard Ratio|0.98||||0.85|TWO_SIDED|95.0|0.84|1.15|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.15|0.84|0.850
71726278|NCT03817463|142966674|OTHER||Adjusted Hazard Ratio|1.03||||0.828|TWO_SIDED|95.0|0.81|1.31|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.31|0.81|0.828
71726279|NCT03817463|142966674|OTHER||Adjusted Hazard Ratio|1.01||||0.944|TWO_SIDED|95.0|0.72|1.42|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.42|0.72|0.944
71830743|NCT00364013|143166519|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9822|TWO_SIDED|95.0|0.65|1.47|||Stratified exact test|Adjusted for geographic region and ECOG score|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.|||1.47|0.65|0.9822
71830744|NCT03482011|143166551|SUPERIORITY||Risk Difference (RD)|63.0|||<|0.001|TWO_SIDED|95.0|56.5|69.4|||Cochran-Mantel-Haenszel|||||69.4|56.5|<0.001
71830745|NCT03482011|143166552|SUPERIORITY||Risk Difference (RD)|57.8|||<|0.001|TWO_SIDED|95.0|51.3|64.4|||Cochran-Mantel-Haenszel|||||64.4|51.3|<0.001
71888361|NCT04426695|143297676|SUPERIORITY|||||||0.0383||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0383
71888362|NCT04426695|143297676|SUPERIORITY|||||||0.3296||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3296
71726280|NCT03817463|142966675|OTHER||Adjusted Hazard Ratio|0.94||||0.642|TWO_SIDED|95.0|0.73|1.22|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.22|0.73|0.642
71726281|NCT03817463|142966675|OTHER||Adjusted Hazard Ratio|0.89||||0.417|TWO_SIDED|95.0|0.66|1.19|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||||1.19|0.66|0.417
71888363|NCT04426695|143297676|SUPERIORITY|||||||0.0766||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0766
71726282|NCT03817463|142966676|OTHER||Adjusted Hazard Ratio|0.89||||0.091|TWO_SIDED|95.0|0.77|1.02|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.02|0.77|0.091
71830746|NCT03482011|143166553|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|11.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|11.6|<0.001
71726283|NCT03817463|142966677|OTHER||Adjusted Hazard Ratio|1.97|||<|0.005|TWO_SIDED|95.0|1.28|3.03|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||3.03|1.28|<0.005
71726284|NCT03817463|142966678|OTHER||Adjusted Hazard Ratio|0.95||||0.654|TWO_SIDED|95.0|0.75|1.2|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.20|0.75|0.654
71830747|NCT03482011|143166554|SUPERIORITY||Risk Difference (RD)|73.6|||<|0.001|TWO_SIDED|95.0|67.1|80.1|||Cochran-Mantel-Haenszel|||||80.1|67.1|<0.001
71830748|NCT03482011|143166555|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.001|TWO_SIDED|95.0|26.0|35.7|||Cochran-Mantel-Haenszel|||||35.7|26.0|<0.001
71830749|NCT03482011|143166556|SUPERIORITY||Risk Difference (RD)|48.1|||<|0.001|TWO_SIDED|95.0|42.9|53.2|||Cochran-Mantel-Haenszel|||||53.2|42.9|<0.001
71830750|NCT03482011|143166557|SUPERIORITY||Risk Difference (RD)|18.3|||<|0.001|TWO_SIDED|95.0|14.5|22.1|||Cochran-Mantel-Haenszel|||||22.1|14.5|<0.001
71830751|NCT03482011|143166558|SUPERIORITY||Risk Difference (RD)|49.6|||<|0.001|TWO_SIDED|95.0|42.8|56.4|||Cochran-Mantel-Haenszel|||||56.4|42.8|<0.001
71830752|NCT03482011|143166559|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|56.0|77.5|||Cochran-Mantel-Haenszel|||||77.5|56.0|<0.001
71830753|NCT03482011|143166559|SUPERIORITY||Risk Difference (RD)|65.9|||<|0.001|TWO_SIDED|95.0|54.9|77.0|||Cochran-Mantel-Haenszel|||||77.0|54.9|<0.001
71726285|NCT03817463|142966679|OTHER||Adjusted Hazard Ratio|0.78||||0.233|TWO_SIDED|95.0|0.52|1.17|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||1.17|0.52|0.233
71726286|NCT03817463|142966680|OTHER||Adjusted Hazard Ratio|0.56|||<|0.005|TWO_SIDED|95.0|0.38|0.82|||Cox proportional hazard model|Cox proportional hazard model adjusted for unbalanced propensity score (PS)-variables at baseline.||Hazards ratios reported include data from all countries with non-missing values.||0.82|0.38|<0.005
71726287|NCT03817463|142966681|OTHER||Rate Ratio|0.74|||||TWO_SIDED|95.0|0.69|0.8|||||Poisson regression model was used.|Emergency room visits - Finland||0.80|0.69|
71726288|NCT03817463|142966681|OTHER||Rate Ratio|0.9|||||TWO_SIDED|95.0|0.59|1.38|||||Poisson regression model was used.|Emergency room visits - Japan||1.38|0.59|
71726289|NCT03817463|142966681|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.0|||||Poisson regression model was used.|Emergency room visits - South Korea||1.00|0.82|
71830754|NCT03482011|143166560|SUPERIORITY||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|1.32|<|0.001|TWO_SIDED|95.0|-7.31|-2.1|||Mixed Models Analysis|||||-2.10|-7.31|<0.001
71830755|NCT03482011|143166561|SUPERIORITY||Mean Difference (Net)|-17.33|STANDARD_ERROR_OF_MEAN|0.99|<|0.001|TWO_SIDED|95.0|-19.28|-15.39|||Mixed Models Analysis|||||-15.39|-19.28|<0.001
71830756|NCT03482011|143166562|SUPERIORITY||Mean Difference (Net)|-6.98|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.37|-3.58|||Mixed Models Analysis|||||-3.58|-10.37|<0.001
71830757|NCT03482011|143166563|SUPERIORITY||Mean Difference (Net)|4.86|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|3.5|6.22|||ANCOVA|||||6.22|3.50|<0.001
71830758|NCT03482011|143166564|SUPERIORITY||Mean Difference (Net)|4.78|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|3.33|6.23|||ANCOVA|||||6.23|3.33|<0.001
71830759|NCT03482011|143166565|SUPERIORITY||Risk Difference (RD)|68.1|||<|0.001|TWO_SIDED|95.0|63.2|72.9|||Cochran-Mantel-Haenszel|||||72.9|63.2|<0.001
71830760|NCT03482011|143166566|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-7.3|-0.06|||ANOVA|||Absenteeism||-0.06|-7.30|0.002
71830761|NCT03482011|143166566|SUPERIORITY||Mean Difference (Net)|-20.24|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-24.89|-15.6|||ANCOVA|||Presenteeism||-15.60|-24.89|<0.001
71830762|NCT03482011|143166566|SUPERIORITY||Mean Difference (Net)|-21.09|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-26.56|-15.62|||ANCOVA|||Overall Absenteeism and Presenteeism||-15.62|-26.56|<0.001
71830763|NCT03482011|143166566|SUPERIORITY||Mean Difference (Net)|-22.91|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-27.39|-18.43|||ANCOVA|||Impairment in Activities Performed Outside of Work||-18.43|-27.39|<0.001
71830764|NCT03482011|143166567|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.79||0.004|TWO_SIDED|95.0|-3.08|4.14|||ANCOVA|||||4.14|-3.08|0.004
71830765|NCT03482011|143166568|SUPERIORITY||Risk Difference (RD)|48.8|||<|0.001|TWO_SIDED|95.0|41.6|55.9|||Cochran-Mantel-Haenszel|||||55.9|41.6|<0.001
71830766|NCT01943799|143166602|SUPERIORITY||LS Mean Difference|-0.001||||0.976|TWO_SIDED|95.0|-0.061|0.059|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.059|-0.061|0.976
71830767|NCT01943799|143166602|SUPERIORITY||LS Mean Difference|-0.007||||0.828|TWO_SIDED|95.0|-0.067|0.053|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.053|-0.067|0.828
71830768|NCT01943799|143166602|SUPERIORITY||LS Mean Difference|-0.029||||0.343|TWO_SIDED|95.0|-0.089|0.031|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.||0.031|-0.089|0.343
71830769|NCT03811574|143166613|SUPERIORITY||Treatment difference|-7.52|||<|0.0001|TWO_SIDED|95.0|-9.62|-5.43|||ANCOVA|||Treatment policy estimand||-5.43|-9.62|<.0001
71830770|NCT03811574|143166613|SUPERIORITY||Treatment difference|-11.06|||<|0.0001|TWO_SIDED|95.0|-12.88|-9.24|||ANCOVA|||Treatment policy estimand||-9.24|-12.88|<.0001
71830771|NCT03811574|143166614|SUPERIORITY||Odds Ratio (OR)|11.08|||<|0.0001|TWO_SIDED|95.0|5.53|22.22|||Regression, Logistic|||Treatment policy estimand||22.22|5.53|<.0001
71830772|NCT03811574|143166614|SUPERIORITY||Odds Ratio (OR)|21.72|||<|0.0001|TWO_SIDED|95.0|11.27|41.86|||Regression, Logistic|||Treatment policy estimand||41.86|11.27|<.0001
71830773|NCT00958633|143166653|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||The hazard ratio for time to any mood episode in the 52-week group relative to the 8-week group was 0.68 (95% confidence interval \[CI\], 0.43 to 1.10; P = 0.12 by log-rank test).|||1.10|0.43|0.12
71726290|NCT03817463|142966681|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Poisson regression model was used.|Emergency room visit - Spain||0.87|0.59|
71726291|NCT03817463|142966681|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.87|1.01|||||Poisson regression model was used.|Emergency room visit - Sweden||1.01|0.87|
71726292|NCT03817463|142966681|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.8|0.93|||||Poisson regression model was used.|Emergency room visit - Taiwan||0.93|0.80|
71830774|NCT00958633|143166654|SUPERIORITY||Hazard Ratio (HR)|2.28|||||TWO_SIDED|95.0|0.86|6.08||||||Manic or Hypomanic events||6.08|.86|
71830775|NCT00958633|143166654|SUPERIORITY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.25|0.75||||||Depressive Events||0.75|0.25|
71830776|NCT03215927|143166659|SUPERIORITY||Median Difference (Net)|-2.55|STANDARD_ERROR_OF_MEAN|3.34|<|0.05|TWO_SIDED|95.0|-9.36|4.26|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||4.26|-9.36|<0.05
71888364|NCT04426695|143297677|SUPERIORITY|||||||0.007||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0070
71888365|NCT04426695|143297677|SUPERIORITY|||||||0.0507||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0507
71888366|NCT04426695|143297677|SUPERIORITY|||||||0.0051||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0051
71888367|NCT04426695|143297678|SUPERIORITY|||||||0.0174||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0174
71888368|NCT04426695|143297678|SUPERIORITY|||||||0.29||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2900
71888369|NCT04426695|143297678|SUPERIORITY|||||||0.0454||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0454
71888370|NCT04426695|143297679|SUPERIORITY|||||||0.004||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0040
71888371|NCT04426695|143297679|SUPERIORITY|||||||0.0413||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0413
71888372|NCT04426695|143297679|SUPERIORITY|||||||0.0032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0032
71888373|NCT04426695|143297680|SUPERIORITY|||||||0.0105||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0105
71888374|NCT04426695|143297680|SUPERIORITY|||||||0.0622||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0622
71726293|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.75|0.85|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Finland||0.85|0.75|
71726294|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.84|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Japan||0.84|0.68|
71888375|NCT04426695|143297680|SUPERIORITY|||||||0.0088||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0088
71888376|NCT04426695|143297681|SUPERIORITY|||||||0.0275||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0275
71888377|NCT04426695|143297681|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
71888378|NCT04426695|143297681|SUPERIORITY|||||||0.0072||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0072
71888379|NCT04426695|143297682|SUPERIORITY|||||||0.1032||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1032
71726295|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.69|0.82|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - South Korea||0.82|0.69|
71888380|NCT04426695|143297682|SUPERIORITY|||||||0.335||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3350
71888381|NCT04426695|143297682|SUPERIORITY|||||||0.1314||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1314
71888382|NCT04426695|143297683|SUPERIORITY|||||||0.00024||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.00024
71888383|NCT04426695|143297683|SUPERIORITY|||||||0.0054||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0054
71726296|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.78|0.94|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Norway||0.94|0.78|
71726297|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.66|0.89|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Spain||0.89|0.66|
71726298|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.81|0.93|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Sweden||0.93|0.81|
71726299|NCT03817463|142966681|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.74|0.86|||||HR and confidence interval were estimated using a cox proportional hazard model, comparing treatment groups and adjusting for unbalanced propensity score (PS)-variables.|First impatient stay - Taiwan||0.86|0.74|
71726300|NCT03817463|142966681|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.64|0.71|||||Poisson regression model was used.|All-cause hospital admissions||0.71|0.64|
71726301|NCT03817463|142966681|OTHER||Rate Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76|||||Poisson regression model was used.|For all-cause hospital admissions - Japan||0.76|0.63|
71726302|NCT03817463|142966681|OTHER||Rate Ratio|0.7|||||TWO_SIDED|95.0|0.66|0.75|||||Poisson regression model was used.|All-cause hospital admissions - South Korea||0.75|0.66|
71726303|NCT03817463|142966681|OTHER||Rate Ratio|0.81|||||TWO_SIDED|95.0|0.77|0.85|||||Poisson regression model was used.|All-cause hospital admissions - Norway||0.85|0.77|
71726304|NCT03817463|142966681|OTHER||Rate Ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||Poisson regression model was used.|All-cause hospital admissions - Spain||0.77|0.60|
71726305|NCT03817463|142966681|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.8|0.89|||||Poisson regression model was used.|All-cause hospital admissions - Sweden||0.89|0.80|
71726306|NCT03817463|142966681|OTHER||Rate Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.87||||||All-cause hospital admissions - Taiwan||0.87|0.72|
71726307|NCT03817463|142966681|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.77|0.79|||||Poisson regression model was used.|Outpatient healthcare visits - Finland||0.79|0.77|
71726308|NCT03817463|142966681|OTHER||Rate Ratio|0.95|||||TWO_SIDED|95.0|0.94|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - Japan||0.97|0.94|
71726309|NCT03817463|142966681|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.96|0.97|||||Poisson regression model was used.|Outpatient healthcare visits - South Korea||0.97|0.96|
71726310|NCT03817463|142966681|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.97||||||Outpatient healthcare visits - Norway||0.97|0.94|
71726311|NCT03817463|142966681|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.85|0.91|||||Poisson regression model was used.|Outpatient healthcare visit - Spain||0.91|0.85|
71888384|NCT04426695|143297683|SUPERIORITY|||||||0.0005||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0005
71726312|NCT03817463|142966681|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.94|0.98|||||Poisson regression model was used.|Outpatient healthcare visits - Sweden||0.98|0.94|
71726313|NCT03817463|142966681|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.94|1.0|||||Poisson regression model was used.|Outpatient healthcare visits - Taiwan||1.00|0.94|
71726314|NCT03817463|142966682|OTHER||Rate Ratio|0.91|||||TWO_SIDED|95.0|0.89|0.94|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Japan||0.94|0.89|
71726315|NCT03817463|142966682|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.81|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - South Korea||0.93|0.81|
71726316|NCT03817463|142966682|OTHER||Rate Ratio|1.09|||||TWO_SIDED|95.0|1.08|1.11|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different antidiabetic drugs - Taiwan||1.11|1.08|
71726317|NCT03817463|142966682|OTHER||Rate Ratio|1.11|||||TWO_SIDED|95.0|1.1|1.12|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Finland||1.12|1.10|
71726318|NCT03817463|142966682|OTHER||Rate Ratio|0.82|||||TWO_SIDED|95.0|0.81|0.83|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Japan||0.83|0.81|
71726319|NCT03817463|142966682|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.99|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - South Korea||1.00|0.99|
71726320|NCT03817463|142966682|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|1.11|1.14|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Norway||1.14|1.11|
71726321|NCT03817463|142966682|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.25|1.27|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Sweden||1.27|1.25|
71726322|NCT03817463|142966682|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on different drugs - Taiwan||1.02|0.98|
71726323|NCT03817463|142966682|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|1.01|1.02|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Finland||1.02|1.01|
71726324|NCT03817463|142966682|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.82|0.84|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Japan||0.84|0.82|
71726325|NCT03817463|142966682|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - South Korea||1.01|0.99|
71726326|NCT03817463|142966682|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.92|0.93|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Norway||0.93|0.92|
71726327|NCT03817463|142966682|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.84|0.87|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Spain||0.87|0.84|
71888385|NCT04426695|143297690|SUPERIORITY|||||||0.0533||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0533
71888386|NCT04426695|143297690|SUPERIORITY|||||||0.0411||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0411
71888387|NCT04426695|143297690|SUPERIORITY|||||||0.0229||||||P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.|Log Rank|||||||0.0229
71888388|NCT04426695|143297691|SUPERIORITY|||||||0.0218|||||||Stratified Log Rank Test|||||||0.0218
71888389|NCT04426695|143297691|SUPERIORITY|||||||0.0156|||||||Stratified Log Rank Test|||||||0.0156
71888390|NCT04426695|143297691|SUPERIORITY|||||||0.0067|||||||Stratified Log Rank Test|||||||0.0067
71726328|NCT03817463|142966682|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Poisson regression model was used.|Pharmacy dispensations/prescriptions based on prescriptions - Sweden||1.00|1.00|
71888391|NCT04426695|143297695|SUPERIORITY|||||||0.2162||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2162
71888392|NCT04426695|143297695|SUPERIORITY|||||||0.8783||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8783
71888393|NCT04426695|143297695|SUPERIORITY|||||||0.5583||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5583
71888394|NCT04426695|143297695|SUPERIORITY|||||||0.7189||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.7189
71657958|NCT02504671|142831748|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71726329|NCT03817463|142966683|OTHER||Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.94|||||Poisson regression model was used.|Total cost - Finland||0.94|0.83|
71726330|NCT03817463|142966683|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||Poisson regression model was used.|Total costs - Norway||1.12|0.86|
71888395|NCT04426695|143297695|SUPERIORITY|||||||0.0429||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0429
71888396|NCT04426695|143297695|SUPERIORITY|||||||0.2103||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2103
71888397|NCT04426695|143297696|SUPERIORITY|||||||0.0223||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0223
71888398|NCT04426695|143297696|SUPERIORITY|||||||0.1256||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1256
71888399|NCT04426695|143297696|SUPERIORITY|||||||0.023||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0230
71726331|NCT03817463|142966683|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.92|1.05|||||Poisson regression model was used.|Total costs - Sweden||1.05|0.92|
71726332|NCT03817463|142966684|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.8|0.88|||||Poisson regression model was used.|||0.88|0.80|
71726333|NCT03817463|142966685|OTHER||Rate Ratio|0.76|||||TWO_SIDED|95.0|0.34|1.68|||||Poisson regression model was used.|Total costs - South Korea||1.68|0.34|
71726334|NCT03817463|142966686|OTHER||Rate Ratio|0.97|||||TWO_SIDED|95.0|0.92|1.03|||||Poisson regression model was used.|Total costs - Taiwan||1.03|0.92|
71726335|NCT02998203|142966710|OTHER|One-sample t-test|||||<|0.001|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||<0.001
71770746|NCT00400153|143041188|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|1.6526|STANDARD_ERROR_OF_MEAN|2.0653||0.4238||95.0|-2.3995|5.7047|||ANCOVA|||||5.7047|-2.3995|0.4238
71888400|NCT04426695|143297696|SUPERIORITY|||||||0.1298||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1298
71888401|NCT04426695|143297696|SUPERIORITY|||||||0.2642||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2642
71888402|NCT04426695|143297696|SUPERIORITY|||||||0.097||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0970
71888403|NCT04426695|143297697|SUPERIORITY|||||||0.0147||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0147
71888404|NCT04426695|143297697|SUPERIORITY|||||||0.0669||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0669
71888405|NCT04426695|143297697|SUPERIORITY|||||||0.0094||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0094
71726336|NCT02998203|142966711|OTHER|non-parametric Wilcoxon rank sum test|||||<|0.001|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||<0.001
71726337|NCT02998203|142966712|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||<0.001
71726338|NCT02998203|142966713|OTHER|Wilcoxon rank sum test||||||0.017|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.017
71726339|NCT02998203|142966714|OTHER|Logistic mixed-effect model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
71726340|NCT02998203|142966715|OTHER|One-sample t-test||||||0.167|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.167
71726341|NCT02998203|142966716|OTHER|Wilcoxon rank sum test||||||0.07|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.07
71726342|NCT02998203|142966717|OTHER|Linear mixed-effect regression model||||||0.014||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||||||0.014
71726343|NCT02998203|142966718|OTHER|One-sample t-test||||||0.023|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.023
71726344|NCT02998203|142966719|OTHER|Wilcoxon rank sum test||||||0.259|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.259
71726345|NCT02998203|142966720|OTHER|Linear mixed-effect regression model|||||<|0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=\<0.001.||||<0.001
71726346|NCT02998203|142966721|OTHER|One-sample t-test||||||0.913|||||||One-sample t-test|||A one-sample t-test was used to assess whether the percent change was different than zero.||||0.913
71726347|NCT02998203|142966722|OTHER|Wilcoxon rank sum test||||||0.338|||||||Wilcoxon rank sum test|||The overall differences in the medians of biomarkers between the conventional and the organic periods were assessed with the non-parametric Wilcoxon rank sum test||||0.338
71726348|NCT02998203|142966723|OTHER|Linear mixed-effect regression model||||||0.001||||||Multiple testing was accounted for using the Benjamini-Hochberg method, considering 58 regression parameter tests of the aforementioned models. Q-value\<0.05 were considered statistically significant (controlling the false discovery rate at 5%).|Mixed Models Analysis|||The interaction term for time and treatment was included in the models since it met the threshold of p-value\<0. 05. Specifically, for the interaction term of time and organic treatment b=-0.016, 95% CI=\[-0.023,-0.010\], p-value=0.01.||||0.001
71726349|NCT02743949|142966735|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0584||||0.748|TWO_SIDED|97.5|0.71|1.5778||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.5778|0.7100|0.7480
71726350|NCT02743949|142966735|SUPERIORITY||Wilcoxon-Mann-Whitney odds estimator|1.0975||||0.5985|TWO_SIDED|97.5|0.7368|1.6349||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test|||||1.6349|0.7368|0.5985
71770747|NCT00400153|143041188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4376|STANDARD_ERROR_OF_MEAN|2.0874||0.2431|TWO_SIDED|95.0|-1.6578|6.533|||ANCOVA|||This analysis is purely exploratory.||6.533|-1.6578|0.2431
71726351|NCT02743949|142966736|SUPERIORITY||Miettinen-Nurminen|0.91||||0.782|TWO_SIDED|97.5|0.44|1.91||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||1.91|0.44|0.782
71726352|NCT02743949|142966736|SUPERIORITY||Miettinen-Nurminen|0.96||||0.912|TWO_SIDED|97.5|0.46|2.01||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square|||||2.01|0.46|0.912
71770748|NCT00400153|143041189|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.056||0.173||95.0|-0.034|0.187|||ANCOVA|||||0.187|-0.034|0.173
71770749|NCT00400153|143041189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.056||0.336|TWO_SIDED|95.0|-0.165|0.056|||ANCOVA|||This analysis is purely exploratory.||0.056|-0.165|0.336
71770750|NCT00400153|143041190|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.924||95.0|-0.115|0.127|||ANCOVA|||||0.127|-0.115|0.924
71888406|NCT04426695|143297697|SUPERIORITY|||||||0.1306||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1306
71657959|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71888407|NCT04426695|143297697|SUPERIORITY|||||||0.3576||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3576
71888408|NCT04426695|143297697|SUPERIORITY|||||||0.1476||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1476
71726353|NCT03389555|142966737|EQUIVALENCE|Equivalence margin: if confidence interval for mean difference between SOFA scores at 72 hour time-point for two groups overlaps 0 (p-value \> 0.05) scores considered to be equivalent. Note: The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups, for those patient for whom a SOFA score could be calculated at the 72 hour time point (i.e patients that were alive at the 72 hour time point, 90 patients in the treatment and 88 patients in the control).|Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||A priori threshold for significance, p-value \< 0.05|Mixed Models Analysis|||The primary outcome was analyzed using a linear mixed-effects model where the correlation of within-patient repeated SOFA score measures was accounted for via the use of an unstructured variance-covariance matrix and linear contrasts. Covariates included age, sex, treatment group, time, and the interaction between treatment group and time. Study site was included as a random intercept. The model estimates the mean difference in SOFA score at 72 hours between treatment and control groups.||0.2|-1.7|0.12
71888409|NCT04426695|143297698|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
71888410|NCT04426695|143297698|SUPERIORITY|||||||0.0535||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0535
71888411|NCT04426695|143297698|SUPERIORITY|||||||0.0199||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0199
71726354|NCT03389555|142966738|EQUIVALENCE|For the key secondary outcome of kidney failure, 200 patients were estimated to provide 94% power, assuming that 30% of participants in the treatment group and 55% in the placebo group would develop kidney failure. If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.58|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of kidney failure in treatment group (intervention versus placebo) controlling for treatment site.||20.0|-10.0|0.58
71726355|NCT03389555|142966739|EQUIVALENCE|If confidence interval for hazard ratio crosses 0, hazard of death assumed to be equivalent in the two groups.|Hazard Ratio (HR)|1.3||||0.05|TWO_SIDED|95.0|0.8|2.2|||Regression, Cox|||Cox Regression controlling for site used to identify hazard ratio for outcome of death for treatment versus intervention group. Null hypothesis is that hazard ratio is 1.||2.2|0.8|0.05
71726356|NCT03389555|142966740|EQUIVALENCE|If the confidence interval for the median difference in ventilator free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|0.0|||>|0.99|TWO_SIDED|95.0|-1.9|1.9|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ventilator free days.||1.9|-1.9|>0.99
71726357|NCT03389555|142966741|EQUIVALENCE|If the confidence interval for the median difference in shock free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.02|TWO_SIDED|95.0|0.2|1.8|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's shock free days.||1.8|0.2|0.02
71726358|NCT03389555|142966742|EQUIVALENCE|If the confidence interval for the median difference in ICU free days between groups crosses 0, the two groups are considered equivalent.|Median Difference (Net)|1.0||||0.69|TWO_SIDED|95.0|-3.0|6.0|||Quantile Regression|||Quantile regression controlling for site performed to compare treatment and control group's ICU free days.||6.0|-3.0|0.69
71726359|NCT03389555|142966743|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|3.0||||0.55|TWO_SIDED|95.0|-10.0|20.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of hospital mortality in treatment group (intervention versus placebo) controlling for treatment site..||20.0|-10.0|0.55
71726360|NCT03389555|142966744|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|2.0||||0.8|TWO_SIDED|95.0|-10.0|10.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of ICU mortality in treatment group (intervention versus placebo) controlling for treatment site.||10.0|-10.0|0.80
71726361|NCT03389555|142966745|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-12.0||||0.16|TWO_SIDED|95.0|-25.0|4.0|||Regression, Logistic|||Logistic regression analysis evaluating the key secondary outcome of occurrence of delirium in treatment group (intervention versus placebo) controlling for treatment site.||4|-25|0.16
71726362|NCT03389555|142966746|EQUIVALENCE|If the adjusted risk difference from the logistic regression analysis overlaps 0, there was considered to be no difference between groups|Risk Difference (RD)|-1.8||||0.82|TWO_SIDED|95.0|-18.0|14.0|||Regression, Logistic|||Logistic regression analysis evaluating home hospital disposition in survivors to hospital discharge in intervention versus placebo group controlling for treatment site.||14|-18|0.82
71770751|NCT00400153|143041190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_ERROR_OF_MEAN|0.062||0.266|TWO_SIDED|95.0|-0.19|0.053|||ANCOVA|||This analysis is purely exploratory.||0.053|-0.19|0.266
71888412|NCT04426695|143297698|SUPERIORITY|||||||0.2784||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2784
71888413|NCT04426695|143297698|SUPERIORITY|||||||0.251||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2510
71726363|NCT00920218|142966759|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|32.31|||<|0.0001|TWO_SIDED|76.16|20.65|50.54|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (\<) 1.||50.54|20.65|<0.0001
71726364|NCT00920218|142966759|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 2.|Fold increase over Control|9.51|||<|0.0001|TWO_SIDED|76.16|6.07|14.9|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group \< 2.||14.9|6.07|<0.0001
71726365|NCT00920218|142966760|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|74.41|||<|0.0001|TWO_SIDED|76.16|33.12|167.17|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group \< 1.||167.17|33.12|<0.0001
71726366|NCT00920218|142966760|SUPERIORITY|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (\>) 3.|Fold increase over Control|42.2|||<|0.0001|TWO_SIDED|76.16|20.2|88.13|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group \< 1.||88.13|20.20|<0.0001
71726367|NCT01007435|142966769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.77|||<|0.0001|TWO_SIDED|95.0|3.19|7.14||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.||7.14|3.19|<0.0001
71726368|NCT01007435|142966769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.47|5.55||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.||5.55|2.47|<0.0001
71726369|NCT01007435|142966769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72|||<|0.0001|TWO_SIDED|95.0|1.8|4.11||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|"Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to non-responder."|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.||4.11|1.80|<0.0001
71726370|NCT02163967|142966783|OTHER||||||<|0.02||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.||The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation||||<.02
71726371|NCT02163967|142966784|OTHER||||||<|0.001|||||||Chi-squared|||The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.||||<.001
71726372|NCT02163967|142966785|OTHER|||||||0.81||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.81
71888414|NCT04426695|143297698|SUPERIORITY|||||||0.1702||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1702
71888415|NCT04426695|143297699|SUPERIORITY|||||||0.05||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0500
71888416|NCT04426695|143297699|SUPERIORITY|||||||0.0663||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0663
71726373|NCT02163967|142966786|OTHER|||||||0.47||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.||||||0.47
71888417|NCT04426695|143297699|SUPERIORITY|||||||0.0229||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0229
71888418|NCT04426695|143297699|SUPERIORITY|||||||0.0208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0208
71726374|NCT01425359|142966840|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Angina frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.008
71726375|NCT01425359|142966841|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Sublingual nitroglycerin use frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model|||||||0.003
71726376|NCT03520348|142966851|NON_INFERIORITY|It is considered less than 20% of differences between groups to consider non-inferiority||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
71726377|NCT03520348|142966852|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.680
71726378|NCT03520348|142966853|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.839|||||||Wilcoxon (Mann-Whitney)|||||||0.839
71726379|NCT03520348|142966854|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.137|||||||Wilcoxon (Mann-Whitney)|||||||0.137
71726380|NCT03520348|142966856|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.667|||||||Chi-squared, Corrected|||||||0.667
71726381|NCT03520348|142966857|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.561|||||||Chi-squared, Corrected|||||||0.561
71726382|NCT03520348|142966858|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||1|||||||Chi-squared|||||||1.000
71726383|NCT03520348|142966859|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.317|||||||Chi-squared, Corrected|||||||0.317
71726384|NCT03520348|142966860|NON_INFERIORITY|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.414|||||||Chi-squared, Corrected|||||||0.414
71726385|NCT02292758|142966861|SUPERIORITY||Hazard Ratio (HR)|0.912||||0.7609|TWO_SIDED|95.0|0.431|1.93|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.930|0.431|0.7609
71726386|NCT02292758|142966861|SUPERIORITY||Hazard Ratio (HR)|0.642|||||TWO_SIDED|95.0|0.249|1.656|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.656|0.249|
71726387|NCT02292758|142966864|SUPERIORITY||Hazard Ratio (HR)|0.471||||0.0446|TWO_SIDED|95.0|0.209|1.062|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.062|0.209|0.0446
71726388|NCT02292758|142966864|SUPERIORITY||Hazard Ratio (HR)|0.406|||||TWO_SIDED|95.0|0.151|1.089|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)|||1.089|0.151|
71726389|NCT02292758|142966866|SUPERIORITY|||||||0.3415|||||||Chi-squared|||||||0.3415
71726390|NCT02292758|142966867|SUPERIORITY|||||||0.1279|||||||Fisher Exact|||||||0.1279
71726391|NCT02292758|142966868|SUPERIORITY|||||||0.447|||||||Log Rank|||||||0.447
71726392|NCT02292758|142966869|SUPERIORITY||Hazard Ratio (HR)|0.755||||0.3738|TWO_SIDED|95.0|0.345|1.655|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)|||1.655|0.345|0.3738
71726393|NCT02292758|142966870|SUPERIORITY|||||||0.4283|||||||Wilcoxon (Mann-Whitney)|||Cetuximab comparison||||0.4283
71726394|NCT02292758|142966870|SUPERIORITY|||||||0.5262|||||||Wilcoxon (Mann-Whitney)|||Irinotecan comparison||||0.5262
71726395|NCT00075946|142966925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.33|TWO_SIDED|95.0|0.9|1.88|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.||1.88|0.90|0.33
71726396|NCT00075946|142966925|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.75||||0.012|TWO_SIDED|95.0|1.22|6.19|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.|||6.19|1.22|0.012
71726397|NCT00075946|142966926|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.21||||0.002|TWO_SIDED|95.0|1.45|7.13|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|||7.13|1.45|0.002
71726398|NCT00075946|142966926|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
71726399|NCT00075946|142966927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.270
71726400|NCT03639623|142966934|OTHER|||||||0.053|||||||paired t-test|||||||0.053
71726401|NCT03639623|142966935|OTHER|||||||0.958|||||||paired t-test|||||||0.958
71726402|NCT03639623|142966936|OTHER|||||||0.011|||||||paired t-test|||||||0.011
71726403|NCT03639623|142966937|OTHER|||||||0.454|||||||paired t-test|||||||0.454
71726404|NCT03639623|142966938|OTHER|||||||0.154|||||||paired t-test|||||||0.154
71726405|NCT03639623|142966939|OTHER|||||||0.125|||||||paired t-test|||Outcome Variable: ALT||||0.125
71726406|NCT03639623|142966939|OTHER|||||||0.375|||||||paired t-test|||Outcome Variable: AST||||0.375
71726407|NCT03639623|142966939|OTHER||||||<|0.001|||||||paired t-test|||Outcome Variable: ALP||||<0.001
71830777|NCT03215927|143166660|SUPERIORITY||Hazard Ratio (HR)|0.66|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED|95.0|0.16|2.77|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||2.77|0.16|<0.05
71830778|NCT03215927|143166661|SUPERIORITY||Mean Difference (Net)|7.51|STANDARD_ERROR_OF_MEAN|8.12|<|0.05|TWO_SIDED|95.0|-8.8|23.83|||Mixed Models Analysis|Adjustments are for baseline FVC, age, and gender, with a repeated measures effect of participant.|The comparison difference value is µABT - µPlacebo.|The null hypothesis for the change outcomes is µABT - µPlacebo = 0.||23.83|-8.80|<0.05
71830779|NCT03215927|143166662|SUPERIORITY||Hazard Ratio (HR)|0.42|STANDARD_ERROR_OF_MEAN|1.16|<|0.05|TWO_SIDED|95.0|0.04|4.02|||Regression, Cox||ABT is the numerator and Placebo is the denominator for the hazard ratios. The dispersion value given is the SE of the estimate on the natural log scale.|The null hypothesis for the time to event outcomes is exp(bABT) / exp(bPlacebo) = 1.||4.02|0.04|<0.05
71830780|NCT02582593|143166663|SUPERIORITY||Cohen's D|0.27||||0.575|TWO_SIDED|||||t = .581, only 1 comparison (2 groups) and thus multiple comparison correction not needed|t-test, 2 sided|||An independent sample t-test was used to examine difference in Pre-post intervention change scores for the Active and Sham groups;. Cohen's d was calculated to determine effect size.||||.575
71888419|NCT04426695|143297699|SUPERIORITY|||||||0.0388||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0388
71888420|NCT04426695|143297699|SUPERIORITY|||||||0.0092||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0092
71888421|NCT04426695|143297703|SUPERIORITY|||||||0.037|||||||stratified log-rank test|||||||0.0370
71888422|NCT04426695|143297703|SUPERIORITY|||||||0.1596|||||||stratified log-rank test|||||||0.1596
71888423|NCT04426695|143297703|SUPERIORITY|||||||0.0444|||||||stratified log-rank test|||||||0.0444
71726408|NCT03639623|142966940|OTHER|||||||0.054|||||||paired t-test|||||||0.054
71726409|NCT03639623|142966941|OTHER|||||||0.378|||||||paired t-test|||Outcome variable: Total Cholesterol||||0.378
71830781|NCT02582593|143166664|SUPERIORITY||Cohen's D|1.06||||0.16|TWO_SIDED|||||t = 1.574; only two comparisons, thus not necessary to adjust|t-test, 2 sided|||independent t-test, cohen's d effect size||||.160
71830782|NCT02582593|143166665|SUPERIORITY||Cohen's D|0.27||||0.424|TWO_SIDED||||||t-test, 2 sided|||independent t-test, Cohen's d effect size||||.424
71888424|NCT04426695|143297703|SUPERIORITY|||||||0.1802|||||||stratified log-rank test|||||||0.1802
71888425|NCT04426695|143297703|SUPERIORITY|||||||0.0407|||||||stratified log-rank test|||||||0.0407
71888426|NCT04426695|143297703|SUPERIORITY|||||||0.0523|||||||stratified log-rank test|||||||0.0523
71888427|NCT04426695|143297704|SUPERIORITY|||||||0.0245|||||||ANCOVA|||||||0.0245
71657960|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71726410|NCT03639623|142966941|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: Triglyceride||||0.010
71726411|NCT03639623|142966941|OTHER|||||||0.264|||||||paired t-test|||Outcome Variable: Non-HDL-C||||0.264
71726412|NCT03639623|142966941|OTHER|||||||0.954|||||||paired t-test|||Outcome Variable: HDL-C||||0.954
71726413|NCT03639623|142966941|OTHER|||||||0.127|||||||paired t-test|||Outcome Variable: HDL-C Subclass 2||||0.127
71726414|NCT03639623|142966941|OTHER|||||||0.029|||||||paired t-test|||Outcome Variable: HDL-C Subclass 3||||0.029
71726415|NCT03639623|142966941|OTHER|||||||0.63|||||||paired t-test|||Outcome variable: LDL-C||||0.630
71726416|NCT03639623|142966941|OTHER|||||||0.01|||||||paired t-test|||Outcome Variable: VLDL-C||||0.010
71726417|NCT03639623|142966941|OTHER|||||||0.16|||||||paired t-test|||Outcome Variable: VLDL concentration||||0.160
71726418|NCT03639623|142966941|OTHER|||||||0.02|||||||paired t-test|||Small dense LDL-C||||0.020
71726419|NCT03639623|142966942|OTHER|||||||0.529|||||||paired t-test|||||||0.529
71830783|NCT02582593|143166666|SUPERIORITY||Cohen's D|-1.03||||0.099|TWO_SIDED|||||no adjustment necessary, only 1 comparison|t-test, 2 sided|||independent sample t-test, Cohen's d effect size||||0.099
71888428|NCT04426695|143297704|SUPERIORITY|||||||0.0554|||||||ANCOVA|||||||0.0554
71888429|NCT04426695|143297704|SUPERIORITY|||||||0.0179|||||||ANCOVA|||||||0.0179
71888430|NCT04426695|143297704|SUPERIORITY|||||||0.0035|||||||ANCOVA|||||||0.0035
71888431|NCT04426695|143297704|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
71888432|NCT04426695|143297704|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71888433|NCT04426695|143297705|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||0.0013
71888434|NCT04426695|143297705|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.0010
71888435|NCT04426695|143297705|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71888436|NCT04426695|143297705|SUPERIORITY|||||||0.025|||||||ANCOVA|||||||0.0250
71888437|NCT04426695|143297705|SUPERIORITY|||||||0.0012|||||||ANCOVA|||||||0.0012
71888438|NCT04426695|143297705|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
71888439|NCT04426695|143297706|SUPERIORITY|||||||0.0623|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0623
71888440|NCT04426695|143297706|SUPERIORITY|||||||0.0203|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0203
71888441|NCT04426695|143297706|SUPERIORITY|||||||0.0193|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0193
71888442|NCT04426695|143297706|SUPERIORITY|||||||0.1206|||||||MMRM|||Difference vs. Placebo by Day 29||||0.1206
71888443|NCT04426695|143297706|SUPERIORITY|||||||0.0911|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0911
71888444|NCT04426695|143297706|SUPERIORITY|||||||0.0645|||||||MMRM|||Difference vs. Placebo by Day 29||||0.0645
71888445|NCT04426695|143297707|SUPERIORITY|||||||0.0623|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0623
71888446|NCT04426695|143297707|SUPERIORITY|||||||0.0203|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0203
71888447|NCT04426695|143297707|SUPERIORITY|||||||0.0193|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0193
71888448|NCT04426695|143297707|SUPERIORITY|||||||0.1206|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.1206
71888449|NCT04426695|143297707|SUPERIORITY|||||||0.0911|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0911
71888450|NCT04426695|143297707|SUPERIORITY|||||||0.0645|||||||MMRM|||Percent Difference vs. Placebo at Day 29||||0.0645
71657961|NCT02504671|142831748|OTHER||Difference|13.5|||||TWO_SIDED|95.0|2.5|24.5|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||24.5|2.5|
71888451|NCT04426695|143297708|SUPERIORITY|||||||0.0481||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0481
71657962|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657963|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657964|NCT02504671|142831748|OTHER||Difference|10.8|||||TWO_SIDED|95.0|0.8|20.8|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||20.8|0.8|
71657965|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657966|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657967|NCT02504671|142831748|OTHER||Difference|8.1|||||TWO_SIDED|95.0|-0.7|16.9|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||16.9|-0.7|
71657968|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71726420|NCT03639623|142966943|OTHER|||||||0.403|||||||paired t-test|||Outcome Variable: LDL Size||||0.403
71726421|NCT03639623|142966944|OTHER|||||||0.669|||||||paired t-test|||||||0.669
71888452|NCT04426695|143297708|SUPERIORITY|||||||0.988||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.9880
71657969|NCT02504671|142831748|OTHER||Difference|16.2|||||TWO_SIDED|95.0|4.3|28.1|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||28.1|4.3|
71657970|NCT02504671|142831748|OTHER||Difference|5.4|||||TWO_SIDED|95.0|-1.9|12.7|||||Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.|||12.7|-1.9|
71657971|NCT02504671|142831749|OTHER||Mean Difference (Net)|-4.09||||0.05|TWO_SIDED|95.0|-8.18|0.0||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, SDAI|||0.00|-8.18|0.050
71657972|NCT02504671|142831749|OTHER||Mean Difference (Net)|-3.66||||0.086|TWO_SIDED|95.0|-7.84|0.52||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||0.52|-7.84|0.086
71657973|NCT02504671|142831749|OTHER||Mean Difference (Net)|-4.33||||0.038|TWO_SIDED|95.0|-8.43|-0.23||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.23|-8.43|0.038
71657974|NCT02504671|142831749|OTHER||Mean Difference (Net)|-4.06||||0.119|TWO_SIDED|95.0|-9.18|1.05||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||1.05|-9.18|0.119
71657975|NCT02504671|142831749|OTHER||Mean Difference (Net)|-4.72||||0.071|TWO_SIDED|95.0|-9.85|0.4||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||0.40|-9.85|0.071
71657976|NCT02504671|142831749|OTHER||Mean Difference (Net)|-5.48||||0.034|TWO_SIDED|95.0|-10.53|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-0.42|-10.53|0.034
71657977|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.78||||0.023|TWO_SIDED|95.0|-12.61|-0.94||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-0.94|-12.61|0.023
71657978|NCT02504671|142831749|OTHER||Mean Difference (Net)|-7.28||||0.014|TWO_SIDED|95.0|-13.09|-1.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-1.47|-13.09|0.014
71657979|NCT02504671|142831749|OTHER||Mean Difference (Net)|-9.23||||0.002|TWO_SIDED|95.0|-14.99|-3.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-3.47|-14.99|0.002
71657980|NCT02504671|142831749|OTHER||Mean Difference (Net)|-5.65||||0.063|TWO_SIDED|95.0|-11.62|0.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||0.32|-11.62|0.063
71726422|NCT03639623|142966945|OTHER|||||||0.021|||||||paired t-test|||Outcome Variable: VLDL chylomicron particles||||0.021
71726423|NCT03639623|142966945|OTHER|||||||0.011|||||||paired t-test|||Outcome Variable: Large VLDL chylomicron particles||||0.011
71888453|NCT04426695|143297708|SUPERIORITY|||||||0.2498||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2498
71888454|NCT04426695|143297708|SUPERIORITY|||||||1||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||1.0000
71726424|NCT03639623|142966945|OTHER|||||||0.06|||||||paired t-test|||Outcome Variable: Medium VLDL particles||||0.060
71726425|NCT03639623|142966945|OTHER|||||||0.324|||||||paired t-test|||Outcome Variable: Small VLDL particles||||0.324
71726426|NCT03639623|142966946|OTHER|||||||0.01|||||||paired t-test|||||||0.010
71726427|NCT03639623|142966947|OTHER|||||||0.249|||||||paired t-test|||||||0.249
71726428|NCT03639623|142966948|OTHER|||||||0.0193|||||||paired t-test|||Time to peak RQ||||0.0193
71726429|NCT03639623|142966949|OTHER|||||||0.96|||||||paired t-test|||Outcome Variable: Physical component score||||0.960
71726430|NCT03639623|142966949|OTHER|||||||0.249|||||||paired t-test|||Outcome Variable: Mental component score||||0.249
71726431|NCT00889603|142966962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.92|||||TWO_SIDED|95.0|1.65|2.2|||||Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.|||2.20|1.65|
71726432|NCT00889603|142966963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|0.75|1.08|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.|||1.08|0.75|
71726433|NCT00889603|142966963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.32|1.8|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||1.80|1.32|
71726434|NCT00889603|142966963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.69|2.25|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.|||2.25|1.69|
71726435|NCT01229254|142966972|EQUIVALENCE|If the 90% confidence interval was within the pre-specified bounds of \[0.66, 1.50\], the hypothesis of similarity between lower weight and higher weight groups was supported.|Ratio of geometric least-squares means|0.748|||||TWO_SIDED|90.0|0.591|0.948||||||Compared to Betrixaban 90 mg (≥80 kg)||0.948|0.591|
71726436|NCT00521599|142966992|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.|Mean Difference (Net)|-1.62|STANDARD_DEVIATION|37.0||0.654|TWO_SIDED|95.0|-8.74|5.49|||ANOVA|||Week 8 End scores||5.49|-8.74|0.654
71726437|NCT00521599|142966992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||ANOVA|||Week 8 End scores||||0.003
71726438|NCT00521599|142966992|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||Week 8 End scores||||0.001
71726439|NCT00744978|142967003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3873|TWO_SIDED|95.0|-1.37|0.53||ANCOVA model using unstructured covariance structure; Type I error rate for primary hypothesis was 5%; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.53|-1.37|0.3873
71726440|NCT00744978|142967004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.2465|TWO_SIDED|95.0|-0.39|1.49||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.49|-0.39|0.2465
71726441|NCT00744978|142967005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.2092|TWO_SIDED|95.0|-0.33|1.5||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.50|-0.33|0.2092
71770752|NCT00400153|143041191|NON_INFERIORITY_OR_EQUIVALENCE|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.065||0.139||95.0|-0.031|0.225|||ANCOVA|||||0.225|-0.031|0.139
71770753|NCT00400153|143041191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.066||0.788|TWO_SIDED|95.0|-0.111|0.146|||ANCOVA|||This analysis is purely exploratory.||0.146|-0.111|0.788
71770754|NCT00400153|143041196|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770755|NCT00400153|143041197|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.482|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
71770756|NCT00400153|143041198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.612|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
71770757|NCT00400153|143041199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.508|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||<0.0001
71770758|NCT00400153|143041200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770759|NCT00400153|143041201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770760|NCT00400153|143041202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770761|NCT00400153|143041203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770762|NCT00400153|143041204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770763|NCT00400153|143041205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.464|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|||||ANOVA|||Difference: Respimat - MDI||||< 0.0001
71770764|NCT01150474|143041226|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
71770765|NCT01150474|143041227|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 2 sided|||||||0.75
71770766|NCT01150474|143041228|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
71770767|NCT01150474|143041229|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
71770768|NCT01150474|143041230|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
71726442|NCT00744978|142967006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.4339|TWO_SIDED|95.0|-1.3|0.56||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.56|-1.30|0.4339
71726443|NCT00744978|142967007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9745|TWO_SIDED|95.0|-0.26|0.27|||ANCOVA|||Difference from placebo analyzed using a mixed effects linear model with subject (nested within sequence) as a random effect, and stratum, site, period, sequence, and treatment as fixed effects.||0.27|-0.26|0.9745
71726444|NCT00744978|142967008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.2852|TWO_SIDED|95.0|-0.57|1.92||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.92|-0.57|0.2852
71726445|NCT00744978|142967009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.0468|TWO_SIDED|95.0|0.02|2.53||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||2.53|0.02|0.0468
71726446|NCT00744978|142967010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8811|TWO_SIDED|95.0|-0.02|0.03||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.03|-0.02|0.8811
71726447|NCT00744978|142967011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.083|TWO_SIDED|95.0|0.0|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.00|0.0830
71726448|NCT00744978|142967012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7226|TWO_SIDED|95.0|-0.03|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.03|0.7226
71726449|NCT00744978|142967013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.5588|TWO_SIDED|95.0|-6.68|3.62||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Week 1: difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.62|-6.68|0.5588
71726450|NCT00744978|142967014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.15||||0.1173|TWO_SIDED|95.0|-9.34|1.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||1.05|-9.34|0.1173
71726451|NCT00744978|142967015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.6251|TWO_SIDED|95.0|-6.58|3.96||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||3.96|-6.58|0.6251
71726452|NCT00744978|142967016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9109|TWO_SIDED|95.0|-0.05|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.05|0.9109
71726453|NCT00744978|142967017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.6632|TWO_SIDED|95.0|-0.06|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.06|0.6632
71726454|NCT00744978|142967018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.545|TWO_SIDED|95.0|-0.07|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.07|0.5450
71770769|NCT01150474|143041231|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
71770770|NCT01150474|143041232|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71770771|NCT01150474|143041233|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
71770772|NCT01150474|143041234|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
71657981|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.29||||0.04|TWO_SIDED|95.0|-12.28|-0.3||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.30|-12.28|0.040
71770773|NCT01423604|143041235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.733||||0.0494|TWO_SIDED|95.0|0.506|1.061||One-sided p-value.|Log Rank|||||1.061|0.506|0.0494
71657982|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.79||||0.024|TWO_SIDED|95.0|-12.69|-0.9||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-0.90|-12.69|0.024
71726455|NCT00744978|142967019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2799|TWO_SIDED|95.0|-0.02|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.05|-0.02|0.2799
71726456|NCT00744978|142967020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9675|TWO_SIDED|95.0|-0.03|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo aAnalyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.04|-0.03|0.9675
71726457|NCT00744978|142967021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5008|TWO_SIDED|95.0|-0.05|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.05|0.5008
71830784|NCT03073941|143166670|NON_INFERIORITY|A non-Inferiority analysis was performed once the 1 year OKS of the first 216 patients were collected. A one-sided T-test, 90% power, SD=10 and with a non-inferiority margin of 4 OKS was used and the analysis was based on the difference of average OKS between Persona and NexGen 1 year postoperatively.|||||<|0.05|||||||t-test, 1 sided|90% power, SD=10 and with a non-inferiority margin of 4 OKS||||||<0.05
71830785|NCT04250883|143166680|SUPERIORITY|||||||0.54|||||||Chi-squared, Corrected|for age||||||0.54
71830786|NCT04250883|143166681|SUPERIORITY|||||||0.97|||||||Chi-squared, Corrected|for age||||||0.97
71830787|NCT04250883|143166683|SUPERIORITY|||||||0.64||||||At 12 days postoperative|Chi-squared, Corrected|for age||||||0.64
71830788|NCT04250883|143166683|SUPERIORITY|||||||0.38||||||At 3 months postoperative|Chi-squared, Corrected|for age||||||0.38
71830789|NCT04250883|143166684|SUPERIORITY|||||||0.84|||||||Chi-squared, Corrected|For age||Count of patients with or without pain at 3 months postoperative||||0.84
71830790|NCT04250883|143166684|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||Number of Words Chosen||||0.89
71830791|NCT04250883|143166684|SUPERIORITY|||||||0.98|||||||ANCOVA|Correction for age||Pain Rating index||||0.98
71830792|NCT04250883|143166685|SUPERIORITY|||||||0.9|||||||ANCOVA|Correction for age||||||0.9
71830793|NCT04250883|143166686|SUPERIORITY|||||||0.68|||||||ANCOVA|Correction for age||At 1 hour||||0.68
71830794|NCT04250883|143166686|SUPERIORITY|||||||0.91|||||||ANCOVA|Correction for age||At 6 hours||||0.91
71830795|NCT04250883|143166686|SUPERIORITY|||||||0.73|||||||ANCOVA|Correction for age||||||0.73
71830796|NCT04250883|143166686|SUPERIORITY|||||||0.77|||||||ANCOVA|Correction for age||||||0.77
71830797|NCT04250883|143166687|SUPERIORITY|||||||0.63|||||||ANCOVA|Correction for age||At 1 hour||||0.63
71830798|NCT04250883|143166687|SUPERIORITY|||||||0.19|||||||ANCOVA|Correction for age||At postoperative day 1||||0.19
71830799|NCT04250883|143166688|SUPERIORITY|||||||0.89|||||||ANCOVA|Correction for age||At 1 hour||||0.89
71830800|NCT04250883|143166688|SUPERIORITY|||||||0.49|||||||ANCOVA|Correction for age||At postoperative day 1||||0.49
71830801|NCT04250883|143166689|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
71830802|NCT04250883|143166690|SUPERIORITY|||||||0.92|||||||ANCOVA|Correction for age||Of Total complications within 30 days postoperative||||0.92
71830803|NCT04250883|143166691|SUPERIORITY|||||||0.098|||||||ANCOVA|correction for age||Time to maximal intensity||||0.098
71830804|NCT04250883|143166691|SUPERIORITY|||||||0.008|||||||ANCOVA|correction for age||Angle from minimal to maximal intensity||||0.008
71830805|NCT04250883|143166691|SUPERIORITY|||||||0.042|||||||ANCOVA|correction for age||Delta between minimal and maximal intensity||||0.042
71830806|NCT04250883|143166692|SUPERIORITY|||||||0.35|||||||ANCOVA|Correction for age||postoperative day 1||||0.35
71830807|NCT04250883|143166692|SUPERIORITY|||||||0.52|||||||ANCOVA|Correction for age||at postoperative day 12||||0.52
71830808|NCT04250883|143166693|SUPERIORITY|||||||0.99|||||||ANCOVA|correction for age||at postoperative day 1||||0.99
71830809|NCT04250883|143166693|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||At postoperative day 12||||0.30
71830810|NCT04250883|143166694|SUPERIORITY|||||||0.42|||||||ANCOVA|Correction for age||||||0.42
71830811|NCT04250883|143166695|SUPERIORITY|||||||0.3|||||||ANCOVA|Correction for age||||||0.3
71830812|NCT04250883|143166696|SUPERIORITY|||||||0.33|||||||ANCOVA|Correction for age||||||0.33
71830813|NCT04250883|143166697|SUPERIORITY|||||||0.018|||||||ANCOVA|Correction for age||||||0.018
71830814|NCT00722046|143166748|SUPERIORITY||Least Squares (LS) Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|3.04||0.6504|TWO_SIDED|90.0|-3.68|6.45|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.45|-3.68|0.6504
71830815|NCT00722046|143166748|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|3.13||0.5213|TWO_SIDED|90.0|-3.2|7.23|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.23|-3.20|0.5213
71830816|NCT00722046|143166748|SUPERIORITY||LS Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|3.13||0.4698|TWO_SIDED|90.0|-2.94|7.48|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||7.48|-2.94|0.4698
71830817|NCT00722046|143166748|SUPERIORITY||LS Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.66||0.5183|TWO_SIDED|90.0|-2.71|6.17|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||6.17|-2.71|0.5183
71726458|NCT00744978|142967022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.2245|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.2245
71726459|NCT00744978|142967023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.4974|TWO_SIDED|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.01|-0.03|0.4974
71726460|NCT00744978|142967024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8525|TWO_SIDED|95.0|-0.02|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.||0.02|-0.02|0.8525
71726461|NCT01218958|142967025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0245|TWO_SIDED|95.0|0.6|0.94||The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).|Andersen-Gill recurrent-event Cox|||"The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.~The method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived."||0.940|0.600|0.0245
71726462|NCT01218958|142967025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0744|TWO_SIDED|95.0|0.677|1.018|||Andersen-Gill recurrent-event Cox model|||||1.018|0.677|0.0744
71726463|NCT01179217|142967046|SUPERIORITY_OR_OTHER_LEGACY||Wilcoxon rank-sum test|0.5||||0.0052|TWO_SIDED|||||"1. The primary analysis was analyzed using a CMH analysis of the number of SCCs using modified ridit scores.~2. P-value (controlling for region and HU use)~3. The null hypothesis of the final analysis was performed at the 0.045 significance level."|Cochran-Mantel-Haenszel|||||||0.0052
71726464|NCT01179217|142967047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
71726465|NCT01179217|142967048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0888|||||||Cochran-Mantel-Haenszel|||||||0.0888
71726466|NCT01849575|142967061|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71726467|NCT04077996|142967073|NON_INFERIORITY|The margin of non inferiority analysis was established at 30%.|Risk Ratio (RR)|1.11|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|0.91|1.3|||Chi-squared, Corrected|||Summary statistics were computed, and a significance level (α) of 5% has been established.||1.3|0.91|<0.05
71726468|NCT04077996|142967073|NON_INFERIORITY|margin 30%|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71888455|NCT04426695|143297708|SUPERIORITY|||||||0.0457||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0457
71726469|NCT04077996|142967074|NON_INFERIORITY|The margin was established at 30%.|Risk Ratio (RR)|1.0|STANDARD_DEVIATION|95.0|<|0.05|TWO_SIDED|1.0|0.14|6.6|||Fisher Exact|||||6.6|0.14|<0.05
71726470|NCT01818258|142967079|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event. Null hypothesis of no difference between cohorts.||||0.40
71657983|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.58||||0.05|TWO_SIDED|95.0|-13.15|-0.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-0.01|-13.15|0.050
71726471|NCT01818258|142967080|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Comparison for number who experienced at least one grade 3 or higher adverse event related to study treatment. Null hypothesis of no difference between cohorts.||||>0.999
71770774|NCT01423604|143041235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0081|TWO_SIDED|95.0|0.281|0.888||One-sided p-value.|Log Rank|||Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) \> 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis||0.888|0.281|0.0081
71770775|NCT01423604|143041236|SUPERIORITY_OR_OTHER||Efron approximation of hazard ratio|0.75||||0.134|TWO_SIDED|95.0|0.513|1.094||Two-sided p-value.|Cox proportional hazards model|||||1.094|0.513|0.1340
71770776|NCT01423604|143041238|SUPERIORITY_OR_OTHER|||||||0.0236|||||||Pearson's chi-square test|||||||0.0236
71726472|NCT01818258|142967081|SUPERIORITY||Geometric Mean Ratio|0.77||||0.49|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.6|0.4|0.49
71726473|NCT01818258|142967081|SUPERIORITY||Geometric Mean Ratio|0.64||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
71726474|NCT01818258|142967081|SUPERIORITY||Geometric Mean Ratio|0.81||||0.63|TWO_SIDED|95.0|0.3|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|0.3|0.63
71770777|NCT00424255|143041240|SUPERIORITY_OR_OTHER|||||||0.2251||95.0||||The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.2251
71770778|NCT00424255|143041240|SUPERIORITY_OR_OTHER|||||||0.4502||95.0||||The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test|||||||0.4502
71770779|NCT00424255|143041240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.85|1.43|||||Hazard Ratios were estimated using a Pike estimator.|||1.43|0.85|
71770780|NCT02290431|143041261|SUPERIORITY||||||<|0.0001|||||||single-sample binomial test|||||||< 0.0001
71726475|NCT01818258|142967082|SUPERIORITY||Geometric Mean Ratio|1.06||||0.89|TWO_SIDED|95.0|0.5|2.3|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of LPV Clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.5|0.89
71726476|NCT01818258|142967082|SUPERIORITY||Geometric Mean Ratio|1.42||||0.37|TWO_SIDED|95.0|0.7|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.7|0.37
71726477|NCT01818258|142967082|SUPERIORITY||Geometric Mean Ratio|1.23||||0.63|TWO_SIDED|95.0|0.5|2.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 Comparison of LPV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.9|0.5|0.63
71726478|NCT01818258|142967083|SUPERIORITY||Geometric Mean Ratio|0.76||||0.42|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 Comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.42
71726479|NCT01818258|142967083|SUPERIORITY||Geometric Mean Ratio|0.58||||0.11|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.11
71726480|NCT01818258|142967083|SUPERIORITY||Geometric Mean Ratio|0.77||||0.44|TWO_SIDED|95.0|0.4|1.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV AUC between cohorts. Null hypothesis of no difference between cohorts.||1.5|0.4|0.44
71726481|NCT01818258|142967084|SUPERIORITY||Geometric Mean Ratio|1.07||||0.84|TWO_SIDED|95.0|0.5|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.5|0.84
71888456|NCT04426695|143297708|SUPERIORITY|||||||0.2153||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2153
71888457|NCT04426695|143297709|SUPERIORITY|||||||0.0811||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0811
71888458|NCT04426695|143297709|SUPERIORITY|||||||0.6701||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.6701
71888459|NCT04426695|143297709|SUPERIORITY|||||||0.2006||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2006
71726482|NCT01818258|142967084|SUPERIORITY||Geometric Mean Ratio|1.54||||0.21|TWO_SIDED|95.0|0.8|3.1|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||3.1|0.8|0.21
71770781|NCT01007253|143041292|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean eye symptoms score difference among the four treatment groups.||||<0.001
71770782|NCT01007253|143041293|SUPERIORITY_OR_OTHER|||||||0.05|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean nasal symptoms score difference among the four treatment groups.||||0.05
71770783|NCT01007253|143041294|SUPERIORITY_OR_OTHER|||||||0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean sneeze difference among the four treatment groups.||||0.001
71770784|NCT01007253|143041295|SUPERIORITY_OR_OTHER|||||||0.11|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean histamine level difference among the four treatment groups.||||0.11
71770785|NCT01007253|143041296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean tryptase level difference among the four treatment groups.||||<0.001
71770786|NCT00814801|143041298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.0113|TWO_SIDED|95.0|-2.64|-0.34|||Least Square Means|||||-0.34|-2.64|0.0113
71770787|NCT00814801|143041298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59|||<|0.0001|TWO_SIDED|95.0|-3.74|-1.44|||Least Square Means|||||-1.44|-3.74|<0.0001
71770788|NCT00814801|143041300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0774|TWO_SIDED|95.0|-0.2|3.7|||Least Square Means|||||3.7|-0.2|0.0774
71770789|NCT00814801|143041300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.6207|TWO_SIDED|95.0|-1.5|2.4|||Least Square Means|||||2.4|-1.5|0.6207
71770790|NCT00814801|143041301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8419|TWO_SIDED|95.0|-0.6|0.8|||Least Square Means|||||0.8|-0.6|0.8419
71770791|NCT00814801|143041301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7942|TWO_SIDED|95.0|-0.8|0.6|||Least Square Means|||||0.6|-0.8|0.7942
71770792|NCT00814801|143041302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.3141|TWO_SIDED|95.0|-1.6|0.5|||Least Square Means|||||0.5|-1.6|0.3141
71770793|NCT00814801|143041302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.6089|TWO_SIDED|95.0|-1.3|0.8|||Least Square Means|||||0.8|-1.3|0.6089
71770794|NCT02751931|143041329|OTHER||Mean Difference (Net)|72.09|||<|0.001|TWO_SIDED|95.0|45.28|98.89||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||98.89|45.28|<0.001
71770795|NCT02751931|143041329|OTHER||Mean Difference (Net)|113.21|||<|0.001|TWO_SIDED|95.0|78.95|147.47||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||147.47|78.95|<0.001
71888460|NCT04426695|143297709|SUPERIORITY|||||||0.3313||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3313
71726483|NCT01818258|142967084|SUPERIORITY||Geometric Mean Ratio|1.29||||0.44|TWO_SIDED|95.0|0.7|2.5|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of RTV clearance between cohorts. Null hypothesis of no difference between cohorts.||2.5|0.7|0.44
71726484|NCT01818258|142967085|SUPERIORITY||Geometric Mean Ratio|0.77||||0.27|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.2|0.5|0.27
71726485|NCT01818258|142967085|SUPERIORITY||Geometric Mean Ratio|0.6||||0.047|TWO_SIDED|95.0|0.4|1.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.0|0.4|0.047
71726486|NCT01818258|142967085|SUPERIORITY||Geometric Mean Ratio|1.09||||0.76|TWO_SIDED|95.0|0.6|1.9|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC AUC between cohorts. Null hypothesis of no difference between cohorts.||1.9|0.6|0.76
71726487|NCT01818258|142967086|SUPERIORITY||Geometric Mean Ratio|0.0||||0.89|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||0.5|-0.4|0.89
71726488|NCT01818258|142967086|SUPERIORITY||Geometric Mean Ratio|1.4||||0.18|TWO_SIDED|95.0|0.8|2.3|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||2.3|0.8|0.18
71726489|NCT01818258|142967086|SUPERIORITY||Geometric Mean Ratio|0.85||||0.53|TWO_SIDED|95.0|0.5|1.4|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of 3TC clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.5|0.53
71726490|NCT01818258|142967087|SUPERIORITY||Geometric Mean Ratio|1.27||||0.39|TWO_SIDED|95.0|0.7|2.2|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.2|0.7|0.39
71726491|NCT01818258|142967087|SUPERIORITY||Geometric Mean Ratio|1.37||||0.43|TWO_SIDED|95.0|0.6|3.0|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||3.0|0.6|0.43
71888461|NCT04426695|143297709|SUPERIORITY|||||||0.5542||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5542
71726492|NCT01818258|142967087|SUPERIORITY||Geometric Mean Ratio|1.52||||0.003|TWO_SIDED|95.0|1.2|2.0|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV AUC between cohorts. Null hypothesis of no difference between cohorts.||2.0|1.2|0.003
71726493|NCT01818258|142967088|SUPERIORITY||Geometric Mean Ratio|0.6||||0.09|TWO_SIDED|95.0|0.3|1.1|||t-test, 2 sided||Week 1 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 1 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.1|0.3|0.090
71726494|NCT01818258|142967088|SUPERIORITY||Geometric Mean Ratio|0.6||||0.23|TWO_SIDED|95.0|0.3|1.4|||t-test, 2 sided||Week 12 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 12 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||1.4|0.3|0.23
71726495|NCT01818258|142967088|SUPERIORITY||Geometric Mean Ratio|0.64||||0.0003|TWO_SIDED|95.0|0.5|0.8|||t-test, 2 sided||Week 24 Geometric Mean Ratio of Severe Malnutrition/Normal Nutrition/Mild Malnutrition|Week 24 comparison of ZDV clearance between cohorts. Null hypothesis of no difference between cohorts.||0.8|0.5|0.0003
71726496|NCT01818258|142967089|SUPERIORITY||Odds Ratio (OR)|0.54||||0.17|TWO_SIDED|95.0|0.22|1.29|||Mixed Models Analysis||Odds Ratio (SAM/non-SAM) for Lopinavir Ctrough \>= 1 ug/mL through 48 weeks|Odds ratio (SAM/non-SAM) of Ctrough \>=1 ug/mL from entry through 48 weeks from repeated measures mixed model, with the null hypothesis that the odds ratio is equal to zero (no difference between cohorts in odds of Ctrough \>=1 ug/mL).||1.29|0.22|0.17
71657984|NCT02504671|142831749|OTHER||Mean Difference (Net)|-9.15||||0.006|TWO_SIDED|95.0|-15.71|-2.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.60|-15.71|0.006
71726497|NCT01818258|142967090|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.003|TWO_SIDED|95.0|-3.9|-0.9|||t-test, 2 sided||Severe Malnutrition Cohort - Normal Nutrition/Mild Malnutrition for Week 1 Free Fraction (%) of LPV|Week 1 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-0.9|-3.9|0.003
71726498|NCT01818258|142967090|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.011|TWO_SIDED|95.0|-6.6|-1.1|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 12 Free Fraction (%) of LPV|Week 12 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||-1.1|-6.6|0.011
71726499|NCT01818258|142967090|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-2.4|4.4|||t-test, 2 sided||Severe Malnutrition - Normal Nutrition/Mild Malnutrition for Week 24 Free Fraction (%) of LPV|Week 24 comparison of LPV free faction. Null hypothesis of no difference between cohorts.||4.4|-2.4|0.46
71726500|NCT01818258|142967091|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.15|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 12. Null hypothesis of no difference between cohorts.||1.7|-0.3|0.15
71726501|NCT01818258|142967091|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 24. Null hypothesis of no difference between cohorts.||1.8|-0.4|0.20
71726502|NCT01818258|142967091|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.13|TWO_SIDED|95.0|-0.2|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 36. Null hypothesis of no difference between cohorts.||1.8|-0.2|0.13
71888462|NCT04426695|143297709|SUPERIORITY|||||||0.2214||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2214
71888463|NCT04426695|143297710|SUPERIORITY|||||||0.0389||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0389
71888464|NCT04426695|143297710|SUPERIORITY|||||||0.5208||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5208
71726503|NCT01818258|142967091|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.089|TWO_SIDED|95.0|-0.1|1.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in log10 plasma HIV viral load from baseline to week 48. Null hypothesis of no difference between cohorts.||1.8|-0.1|0.089
71726504|NCT01818258|142967092|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||Baseline Comparison, with null hypothesis of no difference between cohorts.||||>0.999
71726505|NCT01818258|142967092|SUPERIORITY|||||||0.15|||||||Fisher Exact|||Week 12 Comparison, with null hypothesis of no difference between cohorts.||||0.15
71726506|NCT01818258|142967092|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 24 Comparison, with null hypothesis of no difference between cohorts.||||0.065
71726507|NCT01818258|142967092|SUPERIORITY|||||||0.065|||||||Fisher Exact|||Week 48 Comparison, with null hypothesis of no difference between cohorts.||||0.065
71726508|NCT01818258|142967093|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.89|TWO_SIDED|95.0|-3.9|4.4|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 12. Null hypothesis of no difference between cohorts.||4.4|-3.9|0.89
71726509|NCT01818258|142967093|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.31|TWO_SIDED|95.0|-2.5|7.6|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 24. Null hypothesis of no difference between cohorts.||7.6|-2.5|0.31
71726510|NCT01818258|142967093|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.18|TWO_SIDED|95.0|-1.5|7.8|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference in cohorts of change in CD4 percent from baseline to week 36. Null hypothesis of no difference between cohorts.||7.8|-1.5|0.18
71726511|NCT01818258|142967093|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.018|TWO_SIDED|95.0|1.1|11.0|||t-test, 2 sided||Direction of comparison: Severe Malnutrition - Normal Nutrition/Mild Malnutrition|Difference between cohorts of change in CD4 percent from baseline to week 48. Null hypothesis of no difference between cohorts.||11.0|1.1|0.018
71726512|NCT01818258|142967094|SUPERIORITY||Mean|2.34|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 24 equal to 0||2.91|1.77|<0.0001
71888465|NCT04426695|143297710|SUPERIORITY|||||||0.1079||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1079
71888466|NCT04426695|143297710|SUPERIORITY|||||||0.3315||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3315
71888467|NCT04426695|143297710|SUPERIORITY|||||||0.5797||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.5797
71888468|NCT04426695|143297710|SUPERIORITY|||||||0.3036||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3036
71726513|NCT01818258|142967094|SUPERIORITY||Mean|2.73|||<|0.0001|TWO_SIDED|95.0|2.09|3.37|||t-test, 2 sided|||Null hypothesis: change in WHO weight-for-height Z-score from entry to week 48 equal to 0||3.37|2.09|<0.0001
71726514|NCT01818258|142967095|SUPERIORITY||Mean|2.63|||<|0.0001|TWO_SIDED|95.0|1.96|3.28|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 24 equal to 0||3.28|1.96|<0.0001
71726515|NCT01818258|142967095|SUPERIORITY||Mean|3.53|||<|0.0001|TWO_SIDED|95.0|2.83|4.24|||t-test, 2 sided|||Null hypothesis: change in MUAC from entry to week 48 equal to 0||4.24|2.83|<0.0001
71726516|NCT03655301|142967100|OTHER||Least squares mean|0.9405|||||TWO_SIDED|90.0|0.8093|1.0931||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of Cmax||1.0931|0.8093|
71726517|NCT03655301|142967101|OTHER||Least squares mean|1.1205|||||TWO_SIDED|90.0|1.0|1.2555||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC(0-24)||1.2555|1.0000|
71726518|NCT03655301|142967102|OTHER||Least squares mean|1.1147|||||TWO_SIDED|90.0|0.9772|1.2714||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC||1.2714|0.9772|
71726519|NCT01639339|142967113|OTHER||Odds Ratio (OR)|1.55||||0.0311|TWO_SIDED|95.0|1.04|2.32||P-value was calculated using logistic regression model. Test 1 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.32|1.04|0.0311
71888469|NCT04426695|143297711|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
71888470|NCT04426695|143297711|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
71657985|NCT02504671|142831749|OTHER||Mean Difference (Net)|-8.86||||0.007|TWO_SIDED|95.0|-15.32|-2.41||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-2.41|-15.32|0.007
71657986|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.91||||0.074|TWO_SIDED|95.0|-14.49|0.68||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||0.68|-14.49|0.074
71726520|NCT01639339|142967114|OTHER||Odds Ratio (OR)|1.74||||0.0167|TWO_SIDED|95.0|1.11|2.74||P-value was calculated using logistic regression model. Test 2 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.74|1.11|0.0167
71657987|NCT02504671|142831749|OTHER||Mean Difference (Net)|-10.37||||0.008|TWO_SIDED|95.0|-17.99|-2.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.74|-17.99|0.008
71888471|NCT04426695|143297711|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
71657988|NCT02504671|142831749|OTHER||Mean Difference (Net)|-14.15|||<|0.001|TWO_SIDED|95.0|-21.64|-6.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-6.67|-21.64|<0.001
71657989|NCT02504671|142831749|OTHER||Mean Difference (Net)|-1.88||||0.656|TWO_SIDED|95.0|-10.19|6.43||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||6.43|-10.19|0.656
71657990|NCT02504671|142831749|OTHER||Mean Difference (Net)|-7.0||||0.093|TWO_SIDED|95.0|-15.19|1.19||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||1.19|-15.19|0.093
71657991|NCT02504671|142831749|OTHER||Mean Difference (Net)|-7.26||||0.076|TWO_SIDED|95.0|-15.3|0.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||0.78|-15.30|0.076
71657992|NCT02504671|142831749|OTHER||Mean Difference (Net)|0.8||||0.86|TWO_SIDED|95.0|-8.14|9.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||9.74|-8.14|0.860
71657993|NCT02504671|142831749|OTHER||Mean Difference (Net)|-5.71||||0.196|TWO_SIDED|95.0|-14.4|2.99||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.99|-14.40|0.196
71657994|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.0||||0.164|TWO_SIDED|95.0|-14.48|2.48||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.48|-14.48|0.164
71657995|NCT02504671|142831749|OTHER||Mean Difference (Net)|-10.65||||0.066|TWO_SIDED|95.0|-21.99|0.69||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||0.69|-21.99|0.066
71657996|NCT02504671|142831749|OTHER||Mean Difference (Net)|-16.37||||0.003|TWO_SIDED|95.0|-27.25|-5.49||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.49|-27.25|0.003
71657997|NCT02504671|142831749|OTHER||Mean Difference (Net)|-15.67||||0.004|TWO_SIDED|95.0|-26.3|-5.03||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-5.03|-26.30|0.004
71657998|NCT02504671|142831749|OTHER||Mean Difference (Net)|-4.78||||0.024|TWO_SIDED|95.0|-8.91|-0.65||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-0.65|-8.91|0.024
71657999|NCT02504671|142831749|OTHER||Mean Difference (Net)|-7.77|||<|0.001|TWO_SIDED|95.0|-11.84|-3.7||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI|||-3.70|-11.84|<0.001
71658000|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.67||||0.01|TWO_SIDED|95.0|-11.74|-1.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.60|-11.74|0.010
71658001|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.85||||0.008|TWO_SIDED|95.0|-11.91|-1.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI|||-1.78|-11.91|0.008
71658002|NCT02504671|142831749|OTHER||Mean Difference (Net)|-8.44||||0.004|TWO_SIDED|95.0|-14.2|-2.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-2.67|-14.20|0.004
71658003|NCT02504671|142831749|OTHER||Mean Difference (Net)|-12.51|||<|0.001|TWO_SIDED|95.0|-18.26|-6.75||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI|||-6.75|-18.26|<0.001
71658004|NCT02504671|142831749|OTHER||Mean Difference (Net)|-7.0||||0.022|TWO_SIDED|95.0|-12.99|-1.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-1.01|-12.99|0.022
71658005|NCT02504671|142831749|OTHER||Mean Difference (Net)|-10.16|||<|0.001|TWO_SIDED|95.0|-16.07|-4.24||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI|||-4.24|-16.07|<0.001
71726521|NCT01639339|142967115|OTHER||Odds Ratio (OR)|1.59||||0.0245|TWO_SIDED|95.0|1.06|2.38||P-value was calculated using logistic regression model. Test 3 of 5 in a step-down sequential testing procedure.|Regression, Logistic||Treatment comparison between Belimumab 10 mg/kg and placebo using odds ratio and its corresponding 95% confidence interval has been presented.|||2.38|1.06|0.0245
71770796|NCT02751931|143041330|OTHER||Mean Difference (Net)|-4.09||||0.618|TWO_SIDED|95.0|-20.55|12.38||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||12.38|-20.55|0.618
71888472|NCT04426695|143297711|SUPERIORITY|||||||0.0364||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0364
71888473|NCT04426695|143297711|SUPERIORITY|||||||0.2795||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2795
71888474|NCT04426695|143297711|SUPERIORITY|||||||0.0588||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.0588
71888475|NCT04426695|143297712|SUPERIORITY|||||||0.2635||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2635
71888476|NCT04426695|143297712|SUPERIORITY|||||||0.8013||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.8013
71888477|NCT04426695|143297712|SUPERIORITY|||||||0.416||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.4160
71888478|NCT04426695|143297712|SUPERIORITY|||||||0.2194||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.2194
71888479|NCT04426695|143297712|SUPERIORITY|||||||0.324||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.3240
71888480|NCT04426695|143297712|SUPERIORITY|||||||0.1981||||||P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np \< =5 or n(1-p) \<= 5 in any treatment group, p-value is based on Fisher Exact Test.|Cochran-Mantel-Haenszel|||||||0.1981
71726522|NCT01639339|142967116|OTHER||Cox Proportional Hazard|0.51||||0.0014|TWO_SIDED|95.0|0.34|0.77||P-value was calculated using Cox proportional hazards model. Test 4 of 5 in a step-down sequential testing procedure.|Cox proportional hazards model||Treatment comparison between Belimumab 10 mg/kg and placebo using Cox proportional hazards ratio and its corresponding 95% confidence interval has been presented.|||0.77|0.34|0.0014
71888481|NCT00559273|143297730|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
71658006|NCT02504671|142831749|OTHER||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-17.7|-4.66||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-4.66|-17.70|<0.001
71726523|NCT01639339|142967117|OTHER|||||||0.0096||||||P-value is rank analysis of covariance model comparing Belimumab and Placebo with covariates for treatment group, induction regimen(CYC vs MMF),race(Black vs Non-black), Baseline uPCR, and eGFR. Test 5 of 5 in step-down sequential testing procedure.|Rank ANCOVA|||||||0.0096
71888482|NCT00559273|143297730|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value \<=0.6; alternate hypothesis (H1): p-value \>0.6.||||<0.0001
71888483|NCT00559273|143297731|NON_INFERIORITY_OR_EQUIVALENCE|MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.|Adjusted Mean Difference|-0.036|STANDARD_ERROR_OF_MEAN|0.1097|<|0.0001|TWO_SIDED|95.0|-0.252|0.18|||ANCOVA|||||0.180|-0.252|<0.0001
71888484|NCT03653390|143297759|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
71658007|NCT02504671|142831749|OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-20.57|-7.44||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI|||-7.44|-20.57|<0.001
71658008|NCT02504671|142831749|OTHER||Mean Difference (Net)|-9.68||||0.013|TWO_SIDED|95.0|-17.26|-2.11||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-2.11|-17.26|0.013
71770797|NCT02751931|143041330|OTHER||Mean Difference (Net)|15.16||||0.005|TWO_SIDED|95.0|5.1|25.22||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||25.22|5.10|0.005
71888485|NCT03653390|143297759|SUPERIORITY||Mean Difference (Net)|-1.24||||0.11|TWO_SIDED|95.0|-2.71|0.22|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Wellness Education - EnhanceWellness for Disability|||0.22|-2.71|0.11
71888486|NCT03653390|143297759|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.01|TWO_SIDED|95.0|-3.85|-0.95|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - EnhanceWellness for Disability|||-0.95|-3.85|<0.01
71888487|NCT03653390|143297759|SUPERIORITY||Mean Difference (Net)|-1.16||||0.16|TWO_SIDED|95.0|-2.64|0.32|||Tukey's HSD test|This test inherently adjusts for multiple comparisons.|Difference is calculated as Control - Wellness Education|||0.32|-2.64|0.16
71888488|NCT03653390|143297760|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 6 months.||||||<0.01
71888489|NCT03653390|143297760|SUPERIORITY||Mean Difference (Net)|-2.18||||0.018|TWO_SIDED|95.0|-4.05|-0.3||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.30|-4.05|0.018
71888490|NCT03653390|143297760|SUPERIORITY||Mean Difference (Net)|-2.26||||0.012|TWO_SIDED|95.0|-4.12|-0.41||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.41|-4.12|0.012
71726524|NCT03022097|142967133|SUPERIORITY||Least squares mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.06|0.124||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.124|0.060|<0.001
71726525|NCT03022097|142967134|SUPERIORITY||Least squares mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.053|0.117||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.117|0.053|<0.001
71726526|NCT03022097|142967135|SUPERIORITY||Least squares mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.016|<|0.001|TWO_SIDED|95.0|0.103|0.166||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.166|0.103|<0.001
71726527|NCT03022097|142967136|SUPERIORITY||Least squares mean difference|0.217|STANDARD_ERROR_OF_MEAN|0.017|<|0.001|TWO_SIDED|95.0|0.184|0.25||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|Screening pre- and post-bronchodilator FEV1, age, baseline FEV1 as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||0.250|0.184|<0.001
71726528|NCT03022097|142967137|SUPERIORITY||Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.2|1.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.3|0.2|0.005
71726529|NCT03022097|142967137|SUPERIORITY||Least squares mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.3||0.132|TWO_SIDED|95.0|-0.1|1.0||Pre-specified hierarchical sequence of testing used to adjust for multiplicity.|Mixed Models Analysis|BDI, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||1.0|-0.1|0.132
71726530|NCT03022097|142967138|SUPERIORITY||Least squares mean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003|TWO_SIDED|95.0|-6.7|-1.4||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-1.4|-6.7|0.003
71726531|NCT03022097|142967138|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.3||0.031|TWO_SIDED|95.0|-5.5|-0.3||Pre-specified hierarchical sequence of testing used to adjust for multiplicity. P-value is nominal.|Mixed Models Analysis|Baseline SGRQ, age as covariates; treatment, country, smoking, visit and group-by-visit as factors.||||-0.3|-5.5|0.031
71726532|NCT01349322|142967147|NON_INFERIORITY|Non-inferiority is defined as a hazard ratio upper limit of 2.12.|Hazard Ratio (HR)|1.32||||0.039|TWO_SIDED|90.0|0.84|2.05|||Regression, Cox||Cause-specific hazard ratio; reference level = Arm 1.|"Assuming Arm 1 5-year IBR of 1.59%, for hypothesized upper bound hazard ratio (HR) of 2.12 (Arm 2 5-year IBR of 3.33%), 46 IBR events provide \>80% power to conclude non-inferiority with one-sided significance level = 0.05. Null hypothesis: HR ≥ 2.12 (inferior). Alternative hypothesis: HR \< 2.12 (non-inferior). See Limitations and Caveats section."||2.05|0.84|0.039
71726533|NCT01349322|142967148|SUPERIORITY|||||||0.96||||||Two-sided significance level = 0.05|Log Rank|||||||0.96
71726534|NCT01349322|142967149|SUPERIORITY|||||||0.14||||||Two-sided significance level = 0.05.|Log Rank|||||||0.14
71726535|NCT01349322|142967150|SUPERIORITY|||||||0.34||||||Two-sided significance level = 0.05|Log Rank|||||||0.34
71658009|NCT02504671|142831749|OTHER||Mean Difference (Net)|-16.86|||<|0.001|TWO_SIDED|95.0|-24.39|-9.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI|||-9.32|-24.39|<0.001
71726536|NCT01349322|142967152|NON_INFERIORITY|Null hypothesis (H0) of inferiority: the mean change in cosmetic subscale score in Arm 2 will be at least 0.4 standard deviations worse than in Arm 1. If H0 is rejected, then non-inferiority can be concluded.|Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.62|<|0.0001|TWO_SIDED|95.0|-0.08|0.13||One-side significance level = 0.025|t-test, 1 sided|||||0.13|-0.08|<0.0001
71726537|NCT02063867|142967157|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.17
71726538|NCT02063867|142967158|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.16
71658010|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.03||||0.149|TWO_SIDED|95.0|-14.24|2.18||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||2.18|-14.24|0.149
71726539|NCT02063867|142967159|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.43
71658011|NCT02504671|142831749|OTHER||Mean Difference (Net)|-9.43||||0.019|TWO_SIDED|95.0|-17.32|-1.55||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI|||-1.55|-17.32|0.019
71726540|NCT02063867|142967166|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||<0.001
71726541|NCT02063867|142967167|SUPERIORITY|||||||0.0126||||||Remains significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0126
71726542|NCT02063867|142967168|SUPERIORITY|||||||0.002||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.002
71888491|NCT03653390|143297760|SUPERIORITY||Mean Difference (Net)|-0.08||||0.99|TWO_SIDED|95.0|-1.98|1.81||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||1.81|-1.98|0.99
71888492|NCT03653390|143297761|SUPERIORITY|||||||0.382|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.382
71888493|NCT03653390|143297762|SUPERIORITY|||||||0.29|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.29
71888494|NCT03653390|143297763|SUPERIORITY|||||||0.057|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 3 months.||||||0.057
71888495|NCT03653390|143297764|SUPERIORITY|||||||0.21|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.21
71888496|NCT03653390|143297765|SUPERIORITY|||||||0.79|||||||ANOVA|The ANOVA was conducted on the change in radius of gyration from baseline to 12 months.||||||0.79
71888497|NCT03653390|143297766|SUPERIORITY|||||||0.26|||||||ANOVA|The ANOVA was conducted on the change in number of trips from baseline to 12 months.||||||0.26
71888498|NCT03653390|143297767|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change in minutes from baseline to 12 months.||||||<0.01
71726543|NCT02063867|142967169|SUPERIORITY|||||||0.0032||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals||||||0.0032
71726544|NCT04470908|142967173|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.566|||||TWO_SIDED|90.0|0.525|0.61||||||||0.610|0.525|
71888499|NCT03653390|143297767|SUPERIORITY||Mean Difference (Net)|-28.7||||0.57|TWO_SIDED|95.0|-95.7|38.4||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||38.4|-95.7|0.57
71888500|NCT03653390|143297767|SUPERIORITY||Mean Difference (Net)|66.6||||0.048|TWO_SIDED|95.0|0.56|132.6||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||132.6|0.56|0.048
71888501|NCT03653390|143297767|SUPERIORITY||Mean Difference (Net)|95.3|||<|0.01|TWO_SIDED|95.0|31.8|158.7||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||158.7|31.8|<0.01
71726545|NCT04470908|142967174|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.56|||||TWO_SIDED|90.0|0.532|0.589||||||||0.589|0.532|
71888502|NCT03653390|143297768|SUPERIORITY||||||<|0.01|||||||ANOVA|The ANOVA was conducted on the change scores from baseline to 12 months.||||||<0.01
71888503|NCT03653390|143297768|SUPERIORITY||Mean Difference (Net)|-1.55||||0.028|TWO_SIDED|95.0|-2.97|-0.13||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Wellness Education - EnhanceWellness for Disability|||-0.13|-2.97|0.028
71888504|NCT03653390|143297768|SUPERIORITY||Mean Difference (Net)|-2.15|||<|0.01|TWO_SIDED|95.0|-3.55|-0.75|||Tukey's HSD test||Difference is calculated as Control - EnhanceWellness for Disability|||-0.75|-3.55|<0.01
71888505|NCT03653390|143297768|SUPERIORITY||Mean Difference (Net)|-0.6||||0.59|TWO_SIDED|95.0|-2.03|0.83||This test inherently adjusts for multiple comparisons.|Tukey's HSD test||Difference is calculated as Control - Wellness Education|||0.83|-2.03|0.59
71658012|NCT02504671|142831749|OTHER||Mean Difference (Net)|-6.59||||0.138|TWO_SIDED|95.0|-15.32|2.14||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||2.14|-15.32|0.138
71726546|NCT04470908|142967175|OTHER|Estimate the geometric least square mean ratio of Zanubrutinib vs Zanubrutinib + Rifabutin|Ratio of Geometric Least Squares Means|0.518|||||TWO_SIDED|90.0|0.441|0.608||||||||0.608|0.441|
71726547|NCT02118766|142967182|SUPERIORITY_OR_OTHER|||||||0.038|||||||Regression, Logistic|||||||0.038
71726548|NCT01846299|142967202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78|STANDARD_ERROR_OF_MEAN|1.203||0.0111|TWO_SIDED|95.0|0.4|5.16|||Mixed Models Analysis|||||5.16|0.40|0.0111
71888506|NCT01552681|143297806|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.|ANCOVA|||Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.||||0.33
71888507|NCT02769728|143297828|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||The threshold for statistical significance was p = 0.05||||0.001
71888508|NCT02769728|143297829|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.081
71888509|NCT02769728|143297830|SUPERIORITY|||||||0.114||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.114
71888510|NCT02769728|143297831|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||0.021
71888511|NCT02769728|143297832|SUPERIORITY|||||||1||||||The threshold for statistical significance was p = 0.05|Friedman test|||||||1.00
71888512|NCT02532855|143297903|NON_INFERIORITY|For the primary hypothesis, sitagliptin will be considered non-inferior to dapagliflozin if the upper bound of the two-sided 95% confidence interval (CI) of the between-group difference in least squares mean change from baseline in A1C (sitagliptin minus dapagliflozin) is less than 0.3% (the non-inferiority margin). Longitudinal data analysis (LDA), Antihyperglycemic agent (AHA), Least squares means (LSM)|Difference in LSM (Sit. - Dap.)|-0.15|||||TWO_SIDED|95.0|-0.26|-0.04||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|
71888513|NCT02532855|143297903|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-0.15||||0.006|TWO_SIDED|95.0|-0.26|-0.04|||Longitudinal data analysis|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||-0.04|-0.26|0.006
71888514|NCT02532855|143297904|OTHER||Difference in % (Sit. - Dap.)|-2.8|||||TWO_SIDED|95.0|-10.7|5.1||||Miettinen \& Nurminen method||||5.1|-10.7|
71888515|NCT02532855|143297905|OTHER||Difference in % (Sit. - Dap.)|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||Miettinen \& Nurminen method||||3.0|-3.0|
71888516|NCT02532855|143297906|SUPERIORITY||Difference in LSM (Sit. - Dap.)|-5.7||||0.138|TWO_SIDED|95.0|-13.3|1.8|||LDA|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||1.8|-13.3|0.138
71888517|NCT02532855|143297907|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-3.4|||||TWO_SIDED|95.0|-12.1|5.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline 2-hour PPG value as a covariate.||||5.3|-12.1|
71726549|NCT03095027|142967232|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0||0.01||||||||0.01||
71888518|NCT02532855|143297908|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|-4.4|||||TWO_SIDED|95.0|-10.1|1.4||||The ANCOVA model included terms for treatment, background AHA, and the baseline glucagon AUC value as a covariate.||||1.4|-10.1|
71888519|NCT02532855|143297909|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|4.9|||||TWO_SIDED|95.0|-12.2|22.0||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC value as a covariate.||||22.0|-12.2|
71888520|NCT02532855|143297910|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|0.6|||||TWO_SIDED|95.0|-0.1|1.3||||The ANCOVA model included terms for treatment, background AHA, and the baseline insulin AUC to glucagon AUC ratio value as a covariate.||||1.3|-0.1|
71888521|NCT02532855|143297911|OTHER|The percentage of participants was estimated using standard multiple imputation techniques from LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|Difference in % (Sit. - Dap.)|15.5|||||TWO_SIDED|95.0|7.7|23.2||||Miettinen and Nurminen (M\&N) method with multiple imputation from a LDA Model.||||23.2|7.7|
71888522|NCT02532855|143297912|SUPERIORITY||Difference in the LSM (Sit. - Dap.)|3.5|||||TWO_SIDED|95.0|-1.2|8.3||||LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.||||8.3|-1.2|
71888523|NCT01727258|143297913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.85|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|7.45|14.25||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||14.25|7.45|<0.001
71888524|NCT01727258|143297913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|1.729||0.314|TWO_SIDED|95.0|-5.16|1.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-5.16|0.314
71888525|NCT01727258|143297913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|9.17|16.03||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||16.03|9.17|<0.001
71888526|NCT01727258|143297914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|1.177|<|0.001|TWO_SIDED|95.0|3.76|8.41||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p\<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.41|3.76|<0.001
71888527|NCT01727258|143297914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.183||0.881|TWO_SIDED|95.0|-2.16|2.52||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.52|-2.16|0.881
71888528|NCT01727258|143297914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|STANDARD_ERROR_OF_MEAN|1.182|<|0.001|TWO_SIDED|95.0|3.57|8.24||Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|3.57|<0.001
71888529|NCT01727258|143297915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.72|STANDARD_ERROR_OF_MEAN|2.866||0.02|TWO_SIDED|95.0|-12.38|-1.05||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.05|-12.38|0.020
71888530|NCT01727258|143297915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|2.86||0.964|TWO_SIDED|95.0|-5.52|5.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.78|-5.52|0.964
71888531|NCT01727258|143297915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85|STANDARD_ERROR_OF_MEAN|2.845||0.017|TWO_SIDED|95.0|-12.47|-1.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-1.23|-12.47|0.017
71770798|NCT02751931|143041330|OTHER||Mean Difference (Net)|14.62||||0.055|TWO_SIDED|95.0|-0.31|29.54||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||29.54|-0.31|0.055
71726550|NCT01962987|142967250|EQUIVALENCE|90% confidence interval of the difference in the percentage of patients between Test and Reference to be contained within -20%, + 20%, using the Per-Protocol Population.|(Test-Ref) Difference|0.68|||||TWO_SIDED|90.0|-8.06|9.42|||||Applicable to Percentage of Subjects with Cure (100% complete AK clearance at day 90)|||9.42|-8.06|
71726551|NCT01962987|142967250|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.0010
71888532|NCT01727258|143297916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|STANDARD_ERROR_OF_MEAN|3.327||0.039|TWO_SIDED|95.0|-13.5|-0.35||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.35|-13.50|0.039
71888533|NCT01727258|143297916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|STANDARD_ERROR_OF_MEAN|3.317||0.13|TWO_SIDED|95.0|-1.5|11.61||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||11.61|-1.50|0.130
71658013|NCT02504671|142831749|OTHER||Mean Difference (Net)|-8.7||||0.04|TWO_SIDED|95.0|-16.99|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI|||-0.42|-16.99|0.040
71658014|NCT02504671|142831749|OTHER||Mean Difference (Net)|-15.88||||0.005|TWO_SIDED|95.0|-26.77|-4.98||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-4.98|-26.77|0.005
71770799|NCT02751931|143041330|OTHER||Mean Difference (Net)|13.59|||<|0.001|TWO_SIDED|95.0|6.75|20.42||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||20.42|6.75|<0.001
71770800|NCT02751931|143041331|OTHER||Mean Difference (Net)|41.36|||<|0.001|TWO_SIDED|95.0|18.75|63.97||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change from Baseline at week 4 - Children.||63.97|18.75|<0.001
71770801|NCT02751931|143041331|OTHER||Mean Difference (Net)|80.78|||<|0.001|TWO_SIDED|95.0|39.2|122.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||122.36|39.20|<0.001
71770802|NCT02751931|143041332|OTHER||Mean Difference (Net)|0.44||||0.632|TWO_SIDED|95.0|-1.4|2.28||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||2.28|-1.40|0.632
71770803|NCT02751931|143041332|OTHER||Mean Difference (Net)|-0.64||||0.321|TWO_SIDED|95.0|-1.94|0.67|||t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.67|-1.94|0.321
71770804|NCT02751931|143041332|OTHER||Mean Difference (Net)|-1.86||||0.011|TWO_SIDED|95.0|-3.27|-0.45||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-0.45|-3.27|0.011
71770805|NCT02751931|143041332|OTHER||Mean Difference (Net)|-0.77||||0.359|TWO_SIDED|95.0|-2.49|0.94||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.94|-2.49|0.359
71770806|NCT02751931|143041333|OTHER||Mean Difference (Net)|-12.38|||<|0.001|TWO_SIDED|95.0|-18.56|-6.21||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||-6.21|-18.56|<0.001
71770807|NCT02751931|143041333|OTHER||Mean Difference (Net)|-6.48||||0.334|TWO_SIDED|95.0|-20.09|7.13||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||7.13|-20.09|0.334
71770808|NCT02751931|143041333|OTHER||Mean Difference (Net)|-18.11|||<|0.001|TWO_SIDED|95.0|-24.87|-11.35||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||-11.35|-24.87|<0.001
71770809|NCT02751931|143041333|OTHER||Mean Difference (Net)|-13.19||||0.005||95.0|-22.02|-4.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||-4.36|-22.02|0.005
71770810|NCT02751931|143041334|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
71770811|NCT02751931|143041334|OTHER|||||||0.148||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.148
71770812|NCT02751931|143041334|OTHER|||||||0.002||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||0.002
71770813|NCT02751931|143041334|OTHER|||||||0.039||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||0.039
71770814|NCT02751931|143041335|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children||||<0.001
71770815|NCT02751931|143041335|OTHER|||||||0.007||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents||||0.007
71770816|NCT02751931|143041335|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children||||< 0.001
71770817|NCT02751931|143041335|OTHER||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents||||< 0.001
71770818|NCT02751931|143041336|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||<0.001
71726552|NCT05275010|142967270|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.08|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.08|0.93|
71770819|NCT02751931|143041336|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.006
71770820|NCT02751931|143041336|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||< 0.001
71770821|NCT02751931|143041336|OTHER|||||||0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline was equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||0.001
71770822|NCT02751931|143041337|OTHER||Mean Difference (Net)|14.58||||0.035|TWO_SIDED|95.0|1.0|28.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||28.1|1.0|0.035
71770823|NCT02751931|143041337|OTHER||Mean Difference (Net)|35.99||||0.003|TWO_SIDED|95.0|13.1|58.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||58.9|13.1|0.003
71770824|NCT02751931|143041337|OTHER||Mean Difference (Net)|30.08|||<|0.001|TWO_SIDED|95.0|14.7|45.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||45.5|14.7|<0.001
71770825|NCT02751931|143041337|OTHER||Mean Difference (Net)|51.96|||<|0.001|TWO_SIDED|95.0|24.6|79.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||79.3|24.6|<0.001
71770826|NCT02751931|143041337|OTHER||Mean Difference (Net)|36.9|||<|0.001|TWO_SIDED|95.0|22.7|51.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||51.1|22.7|<0.001
71770827|NCT02751931|143041337|OTHER||Mean Difference (Net)|45.1|||<|0.001|TWO_SIDED|95.0|21.3|68.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||68.9|21.3|<0.001
71770828|NCT02751931|143041337|OTHER||Mean Difference (Net)|32.25|||<|0.001|TWO_SIDED|95.0|18.2|46.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||46.3|18.2|<0.001
71770829|NCT02751931|143041337|OTHER||Mean Difference (Net)|43.94||||0.001|TWO_SIDED|95.0|19.2|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|19.2|0.001
71770830|NCT02751931|143041337|OTHER||Mean Difference (Net)|41.63|||<|0.001|TWO_SIDED|95.0|23.3|60.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||60.0|23.3|<0.001
71770831|NCT02751931|143041337|OTHER||Mean Difference (Net)|59.31||||0.002|TWO_SIDED|95.0|23.8|94.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||94.9|23.8|0.002
71770832|NCT02751931|143041337|OTHER||Mean Difference (Net)|53.87|||<|0.001|TWO_SIDED|95.0|24.5|83.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||83.2|24.5|<0.001
71770833|NCT02751931|143041337|OTHER||Mean Difference (Net)|52.14||||0.002|TWO_SIDED|95.0|20.5|83.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||83.8|20.5|0.002
71770834|NCT02751931|143041337|OTHER||Mean Difference (Net)|42.84|||<|0.001|TWO_SIDED|95.0|22.0|63.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||63.7|22.0|<0.001
71770835|NCT02751931|143041337|OTHER||Mean Difference (Net)|42.4||||0.008|TWO_SIDED|95.0|12.5|72.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||72.3|12.5|0.008
71770836|NCT02751931|143041338|OTHER||Mean Difference (Net)|17.5||||0.126|TWO_SIDED|95.0|-5.1|40.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.1|-5.1|0.126
71770837|NCT02751931|143041338|OTHER||Mean Difference (Net)|42.38||||0.014|TWO_SIDED|95.0|9.3|75.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||75.4|9.3|0.014
71770838|NCT02751931|143041338|OTHER||Mean Difference (Net)|46.69|||<|0.001|TWO_SIDED|95.0|21.7|71.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||71.7|21.7|<0.001
71770839|NCT02751931|143041338|OTHER||Mean Difference (Net)|73.25||||0.002|TWO_SIDED|95.0|29.3|117.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||117.2|29.3|0.002
71770840|NCT02751931|143041338|OTHER|Pre-Specified|Mean Difference (Net)|45.27|||<|0.001|TWO_SIDED|95.0|22.1|68.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||68.4|22.1|<0.001
71770841|NCT02751931|143041338|OTHER||Mean Difference (Net)|42.86||||0.02|TWO_SIDED|95.0|7.4|78.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.3|7.4|0.020
71770842|NCT02751931|143041338|OTHER||Mean Difference (Net)|33.23||||0.003|TWO_SIDED|95.0|12.2|54.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||54.3|12.2|0.003
71770843|NCT02751931|143041338|OTHER||Mean Difference (Net)|47.29||||0.003|TWO_SIDED|95.0|17.8|76.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||76.8|17.8|0.003
71770844|NCT02751931|143041338|OTHER||Mean Difference (Net)|49.88||||0.004|TWO_SIDED|95.0|17.1|82.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||82.6|17.1|0.004
71770845|NCT02751931|143041338|OTHER||Mean Difference (Net)|84.39||||0.003|TWO_SIDED|95.0|31.6|137.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||137.1|31.6|0.003
71770846|NCT02751931|143041338|OTHER||Mean Difference (Net)|60.09||||0.003|TWO_SIDED|95.0|21.2|99.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||99.0|21.2|0.003
71770847|NCT02751931|143041338|OTHER||Mean Difference (Net)|54.78||||0.017|TWO_SIDED|95.0|10.6|98.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||98.9|10.6|0.017
71770848|NCT02751931|143041338|OTHER||Mean Difference (Net)|53.51||||0.001|TWO_SIDED|95.0|22.6|84.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||84.4|22.6|0.001
71770849|NCT02751931|143041338|OTHER||Mean Difference (Net)|54.3||||0.021|TWO_SIDED|95.0|9.0|99.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.6|9.0|0.021
71770850|NCT02751931|143041339|OTHER||Mean Difference (Net)|18.13||||0.113|TWO_SIDED|95.0|-4.5|40.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.7|-4.5|0.113
71770851|NCT02751931|143041339|OTHER||Mean Difference (Net)|35.58||||0.056|TWO_SIDED|95.0|-1.1|72.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||72.2|-1.1|0.056
71770852|NCT02751931|143041339|OTHER||Mean Difference (Net)|37.71||||0.005|TWO_SIDED|95.0|11.7|63.7|||t-test, 2 sided|From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.||Change From Baseline at Week 4 - Children||63.7|11.7|0.005
71770853|NCT02751931|143041339|OTHER||Mean Difference (Net)|70.35||||0.006|TWO_SIDED|95.0|22.2|118.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||118.5|22.2|0.006
71830818|NCT00722046|143166748|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.7529|TWO_SIDED|90.0|-3.65|5.35|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.35|-3.65|0.7529
71830819|NCT00722046|143166750|SUPERIORITY||LS Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|5.59||0.4688|TWO_SIDED|90.0|-13.38|5.24|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.24|-13.38|0.4688
71770854|NCT02751931|143041339|OTHER||Mean Difference (Net)|43.91|||<|0.001|TWO_SIDED|95.0|21.0|66.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||66.8|21.0|<0.001
71770855|NCT02751931|143041339|OTHER||Mean Difference (Net)|38.11||||0.063|TWO_SIDED|95.0|-2.2|78.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||78.4|-2.2|0.063
71770856|NCT02751931|143041339|OTHER||Mean Difference (Net)|29.05||||0.008|TWO_SIDED|95.0|8.2|49.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||49.9|8.2|0.008
71770857|NCT02751931|143041339|OTHER||Mean Difference (Net)|43.04||||0.009|TWO_SIDED|95.0|11.9|74.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||74.2|11.9|0.009
71770858|NCT02751931|143041339|OTHER||Mean Difference (Net)|44.2||||0.006|TWO_SIDED|95.0|13.2|75.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||75.2|13.2|0.006
71770859|NCT02751931|143041339|OTHER||Mean Difference (Net)|81.37||||0.003|TWO_SIDED|95.0|30.4|132.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||132.3|30.4|0.003
71770860|NCT02751931|143041339|OTHER||Mean Difference (Net)|58.49||||0.004|TWO_SIDED|95.0|19.8|97.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||97.2|19.8|0.004
71770861|NCT02751931|143041339|OTHER||Mean Difference (Net)|50.9||||0.039|TWO_SIDED|95.0|2.7|99.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||99.1|2.7|0.039
71770862|NCT02751931|143041339|OTHER||Mean Difference (Net)|53.76||||0.002|TWO_SIDED|95.0|21.7|85.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||85.8|21.7|0.002
71770863|NCT02751931|143041339|OTHER||Mean Difference (Net)|49.13||||0.057|TWO_SIDED|95.0|-1.6|99.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||99.8|-1.6|0.057
71770864|NCT02751931|143041340|OTHER||Mean Difference (Net)|7.98||||0.617|TWO_SIDED|95.0|-24.0|40.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||40.0|-24.0|0.617
71658015|NCT02504671|142831749|OTHER||Mean Difference (Net)|-20.87|||<|0.001|TWO_SIDED|95.0|-31.2|-10.53||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI|||-10.53|-31.20|<0.001
71658016|NCT02504671|142831750|OTHER||Mean Difference (Net)|-3.84||||0.063|TWO_SIDED|95.0|-7.89|0.2||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.20|-7.89|0.063
71658017|NCT02504671|142831750|OTHER||Mean Difference (Net)|-3.84||||0.067|TWO_SIDED|95.0|-7.95|0.28||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.28|-7.95|0.067
71658018|NCT02504671|142831750|OTHER||Mean Difference (Net)|-4.43||||0.032|TWO_SIDED|95.0|-8.46|-0.39||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-0.39|-8.46|0.032
71658019|NCT02504671|142831750|OTHER||Mean Difference (Net)|-4.17||||0.102|TWO_SIDED|95.0|-9.17|0.84||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||0.84|-9.17|0.102
71658020|NCT02504671|142831750|OTHER||Mean Difference (Net)|-3.47||||0.17|TWO_SIDED|95.0|-8.43|1.49||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||1.49|-8.43|0.170
71658021|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.2||||0.039|TWO_SIDED|95.0|-10.13|-0.27||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-0.27|-10.13|0.039
71726553|NCT05275010|142967271|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the AUC0-62 values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.0|||||TWO_SIDED|90.0|0.93|1.09|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.09|0.93|
71726554|NCT05275010|142967272|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for pertuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.96|1.12|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.12|0.96|
71726555|NCT05275010|142967273|EQUIVALENCE|The null hypothesis will be rejected and bioequivalence will be concluded if the bounds of the 90% CI for the geometric mean ratio of the Cmax values for trastuzumab by administration using OBDS (Arm 2) relative to the handheld syringe (Arm 1) are entirely contained within standard bioequivalence margins (0.8 to 1.25).|Geometric Mean Ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.95|1.13|||||GMR of test treatment group (Arm 2: PH FDC SC using OBDS) to reference treatment group (Arm 1: PH FDC SC using handheld syringe).|||1.13|0.95|
71726556|NCT03327220|142967318|SUPERIORITY||Difference in Means|1.3||||0.0841|TWO_SIDED|95.0|-0.6|3.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that true iovera° mean was greater than or equal to the true standard of care mean versus the alternative hypothesis that true iovera° mean was less than true standard of care mean.||3.2|-0.6|0.0841
71726557|NCT03327220|142967319|NON_INFERIORITY|The objective met if the t-test for non-inferiority was statistically significant using a one-sided α = 0.025 level of statistical significance.|Difference in Means|1.9|||<|0.0001|TWO_SIDED|95.0|-2.3|6.1||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing null hypothesis that Standard of Care mean minus the iovera° mean was greater than or equal to non-inferiority margin of 14 versus alternative hypothesis that difference in means was less than 14.||6.1|-2.3|<0.0001
71726558|NCT03327220|142967320|SUPERIORITY||Difference in Means|0.5||||0.0946|TWO_SIDED|95.0|-0.2|1.2||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Pain in the Past 7 days - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||1.2|-0.2|0.0946
71726559|NCT03327220|142967320|SUPERIORITY|Pain Right Now - Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.|Difference in Means|0.4||||0.2204|TWO_SIDED|95.0|-0.6|1.3||p-value was calculated from a one-sided, two-sample t-test,|t-test, 1 sided|||||1.3|-0.6|0.2204
71658022|NCT02504671|142831750|OTHER||Mean Difference (Net)|-7.2||||0.012|TWO_SIDED|95.0|-12.82|-1.57||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.57|-12.82|0.012
71658023|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.73||||0.018|TWO_SIDED|95.0|-12.3|-1.16||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-1.16|-12.30|0.018
71658024|NCT02504671|142831750|OTHER||Mean Difference (Net)|-9.19||||0.001|TWO_SIDED|95.0|-14.73|-3.66||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-3.66|-14.73|0.001
71658025|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.48||||0.065|TWO_SIDED|95.0|-11.31|0.35||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.35|-11.31|0.065
71658026|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.85||||0.05|TWO_SIDED|95.0|-11.69|0.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.00|-11.69|0.050
71658027|NCT02504671|142831750|OTHER||Mean Difference (Final Values)|-6.63||||0.024|TWO_SIDED|95.0|-12.38|-0.87||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-0.87|-12.38|0.024
71658028|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.41||||0.051|TWO_SIDED|95.0|-12.84|0.02||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||0.02|-12.84|0.051
71726560|NCT03327220|142967321|SUPERIORITY||Difference in Means|-0.8||||0.3231|TWO_SIDED|95.0|-4.0|2.5||p-value was calculated from a one-sided, two-sample t-test.|t-test, 1 sided|||Testing the null hypothesis that the iovera° mean was less than or equal to the Standard of Care mean versus the alternative hypothesis that the iovera° mean was greater than the Standard of Care mean.||2.5|-4.0|0.3231
71726561|NCT00523705|142967324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|STANDARD_ERROR_OF_MEAN|4.86||0.467|TWO_SIDED||||||Regression, Linear||estimate of main effect of treatment in a linear mixed effects model.|Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.||||0.467
71726562|NCT03077438|142967336|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|7.6|||||TWO_SIDED|95.0|1.1|14.0||||||Serogroup A||14|1.1|
71726563|NCT03077438|142967336|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|47.4|||||TWO_SIDED|95.0|42.2|52.2||||||Serogroup C||52.2|42.2|
71726564|NCT03077438|142967336|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|12.2|||||TWO_SIDED|95.0|7.7|16.7||||||Serogroup Y||16.7|7.7|
71726565|NCT03077438|142967336|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|14.8|||||TWO_SIDED|95.0|8.9|20.5||||||Serogroup W||20.5|8.9|
71726566|NCT03077438|142967337|OTHER||GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32||||||Serogroup A||1.32|0.91|
71726567|NCT03077438|142967337|OTHER||GMT Ratio|14.0|||||TWO_SIDED|95.0|11.3|17.3||||||Serogroup C||17.3|11.3|
71726568|NCT03077438|142967337|OTHER||GMT Ratio|1.58|||||TWO_SIDED|95.0|1.31|1.9||||||Serogroup Y||1.9|1.31|
71726569|NCT03077438|142967337|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.21|1.69||||||Serogroup W||1.69|1.21|
71726570|NCT03077438|142967338|OTHER||GMT Ratio|1.14|||||TWO_SIDED|95.0|0.883|1.47||||||Serogroup A||1.47|0.883|
71726571|NCT03077438|142967338|OTHER||GMT Ratio|17.4|||||TWO_SIDED|95.0|13.4|22.6||||||Serogroup C||22.6|13.4|
71726572|NCT03077438|142967338|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.07|1.78||||||Serogroup Y||1.78|1.07|
71726573|NCT03077438|142967338|OTHER||GMT Ratio|1.43|||||TWO_SIDED|95.0|1.12|1.83||||||Serogroup W||1.83|1.12|
71726574|NCT03077438|142967339|OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.816|1.38||||||Serogroup A||1.38|0.816|
71726575|NCT03077438|142967339|OTHER||GMT Ratio|11.5|||||TWO_SIDED|95.0|8.24|16.0||||||Serogroup C||16|8.24|
71726576|NCT03077438|142967339|OTHER||GMT Ratio|1.84|||||TWO_SIDED|95.0|1.41|2.38||||||Serogroup Y||2.38|1.41|
71726577|NCT03077438|142967339|OTHER||GMT Ratio|1.45|||||TWO_SIDED|95.0|1.16|1.82||||||Serogroup W||1.82|1.16|
71726578|NCT03077438|142967340|OTHER||Percentage Difference|7.6|||||TWO_SIDED|95.0|-1.6|16.7||||||Serogroup A||16.7|-1.6|
71726579|NCT03077438|142967340|OTHER||Percentage Difference|51.1|||||TWO_SIDED|95.0|43.5|57.8||||||Serogroup C||57.8|43.5|
71726580|NCT03077438|142967340|OTHER||Percentage Difference|11.2|||||TWO_SIDED|95.0|4.2|18.1||||||Serogroup Y||18.1|4.2|
71726581|NCT03077438|142967340|OTHER||Percentage Difference|12.5|||||TWO_SIDED|95.0|3.9|20.9||||||Serogroup W||20.9|3.9|
71770865|NCT02751931|143041340|OTHER||Mean Difference (Net)|39.52||||0.035|TWO_SIDED|95.0|3.0|76.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||76.0|3.0|0.035
71726582|NCT03077438|142967341|OTHER||Percentage Difference|7.7|||||TWO_SIDED|95.0|-1.3|16.6||||||Serogroup A||16.6|-1.3|
71726583|NCT03077438|142967341|OTHER||Percentage Difference|44.0|||||TWO_SIDED|95.0|36.8|50.6||||||Serogroup C||50.6|36.8|
71726584|NCT03077438|142967341|OTHER||Percentage Difference|13.3|||||TWO_SIDED|95.0|7.6|19.2||||||Serogroup Y||19.2|7.6|
71726585|NCT03077438|142967341|OTHER||Percentage Difference|17.2|||||TWO_SIDED|95.0|9.4|24.7||||||Serogroup W||24.7|9.4|
71726586|NCT04392141|142967346|EQUIVALENCE|equivalence of odds of death between both groups|Odds Ratio (OR)|9.87||||0.0318|TWO_SIDED|95.0|1.16|83.89|||Fisher Exact|||||83.89|1.16|0.0318
71726587|NCT04392141|142967347|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-5.5||||0.0001|TWO_SIDED|95.0|-7.03|-3.96|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 (%) between admission and discharge times in standard treatment group||-3.96|-7.03|0.0001
71726588|NCT04392141|142967347|EQUIVALENCE|equivalence of SpO2 percentage between admission and discharge phases|Mean Difference (Final Values)|-2.55||||0.0001|TWO_SIDED|95.0|-3.28|-1.81|||t-test, 2 sided|Paired T-test||Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-1.81|-3.28|0.0001
71726589|NCT04392141|142967348|EQUIVALENCE|equivalence of means of the length of hospitalization between both groups|Mean Difference (Final Values)|2.22||||0.0001|TWO_SIDED|95.0|1.63|2.8|||Wilcoxon (Mann-Whitney)|||||2.80|1.63|0.0001
71726590|NCT04392141|142967349|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|0.02||||0.8|TWO_SIDED|95.0|-0.136|0.176|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in standard treatment||0.176|-0.136|0.80
71770866|NCT02751931|143041340|OTHER||Mean Difference (Net)|19.81||||0.167|TWO_SIDED|95.0|-8.7|48.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||48.3|-8.7|0.167
71770867|NCT02751931|143041340|OTHER||Mean Difference (Net)|75.25||||0.005|TWO_SIDED|95.0|25.8|124.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||124.7|25.8|0.005
71888534|NCT01727258|143297916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.98|STANDARD_ERROR_OF_MEAN|3.313|<|0.001|TWO_SIDED|95.0|-18.53|-5.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-5.43|-18.53|<0.001
71888535|NCT01727258|143297917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|STANDARD_ERROR_OF_MEAN|3.163||0.01|TWO_SIDED|95.0|-14.51|-2.0||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-2.00|-14.51|0.010
71888536|NCT01727258|143297917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|3.16||0.179|TWO_SIDED|95.0|-1.98|10.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||10.51|-1.98|0.179
71888537|NCT01727258|143297917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.52|STANDARD_ERROR_OF_MEAN|3.172|<|0.001|TWO_SIDED|95.0|-18.79|-6.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-6.25|-18.79|<0.001
71888538|NCT01727258|143297918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.93|STANDARD_ERROR_OF_MEAN|3.543|<|0.001|TWO_SIDED|95.0|-18.93|-4.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.93|-18.93|<0.001
71888539|NCT01727258|143297918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.54|STANDARD_ERROR_OF_MEAN|3.534||0.119|TWO_SIDED|95.0|-1.44|12.53||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||12.53|-1.44|0.119
71888540|NCT01727258|143297918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-24.52|-10.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-10.42|-24.52|<0.001
71888541|NCT00773279|143297957|NON_INFERIORITY_OR_EQUIVALENCE|"A two-sided 95 % Confidence Interval (CI) for the treatment difference, PDS290 minus FlexPen, in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute)."|Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.127|0.032|||Linear mixed effect model|Linear mixed effect model with period and delivery systems as fixed effects, and subject as a random effect.||The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).||0.032|-0.127|
71658029|NCT02504671|142831750|OTHER||Mean Difference (Net)|-8.6||||0.008|TWO_SIDED|95.0|-14.97|-2.22||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.22|-14.97|0.008
71658030|NCT02504671|142831750|OTHER||Mean Difference (Net)|-8.74||||0.007|TWO_SIDED|95.0|-15.06|-2.43||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-2.43|-15.06|0.007
71658031|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.8||||0.071|TWO_SIDED|95.0|-14.19|0.58||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||0.58|-14.19|0.071
71770868|NCT02751931|143041340|OTHER||Mean Difference (Net)|34.01||||0.02|TWO_SIDED|95.0|5.7|62.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||62.3|5.7|0.020
71658032|NCT02504671|142831750|OTHER||Mean Difference (Net)|-9.8||||0.009|TWO_SIDED|95.0|-17.17|-2.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.44|-17.17|0.009
71658033|NCT02504671|142831750|OTHER||Mean Difference (Net)|-13.88|||<|0.001|TWO_SIDED|95.0|-21.17|-6.59||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-6.59|-21.17|<0.001
71658034|NCT02504671|142831750|OTHER||Mean Difference (Net)|-1.68||||0.676|TWO_SIDED|95.0|-9.63|6.26||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||6.26|-9.63|0.676
71658035|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.33||||0.11|TWO_SIDED|95.0|-14.11|1.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.44|-14.11|0.110
71658036|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.44||||0.099|TWO_SIDED|95.0|-14.12|1.23||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||1.23|-14.12|0.099
71658037|NCT02504671|142831750|OTHER||Mean Difference (Net)|1.04||||0.812|TWO_SIDED|95.0|-7.61|9.69||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||9.69|-7.61|0.812
71770869|NCT02751931|143041340|OTHER||Mean Difference (Net)|44.43||||0.033|TWO_SIDED|95.0|3.9|84.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||84.9|3.9|0.033
71726591|NCT04392141|142967349|EQUIVALENCE|equivalence of mean of lymphocytes count between admission and discharge phases|Mean Difference (Final Values)|-0.43||||0.0001|TWO_SIDED|95.0|-0.63|-0.23|||t-test, 2 sided|Paired T-test||Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||-0.23|-0.63|0.0001
71658038|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.39||||0.204|TWO_SIDED|95.0|-13.75|2.96||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.96|-13.75|0.204
71726592|NCT04392141|142967350|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|-26.06||||0.602|TWO_SIDED|95.0|-124.76|72.64|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in standard treatment||72.64|-124.76|0.602
71770870|NCT02751931|143041340|OTHER||Mean Difference (Net)|8.68||||0.503|TWO_SIDED|95.0|-17.3|34.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0|t-test, 2 sided|||Change From Baseline at Week 12 - Children||34.7|-17.3|0.503
71770871|NCT02751931|143041340|OTHER||Mean Difference (Net)|38.23||||0.016|TWO_SIDED|95.0|7.8|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||68.6|7.8|0.016
71770872|NCT02751931|143041340|OTHER||Mean Difference (Net)|40.76||||0.043|TWO_SIDED|95.0|1.4|80.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||80.2|1.4|0.043
71770873|NCT02751931|143041340|OTHER||Mean Difference (Net)|86.66|||<|0.001|TWO_SIDED|95.0|41.5|131.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||131.8|41.5|<0.001
71770874|NCT02751931|143041340|OTHER||Mean Difference (Net)|31.08||||0.203|TWO_SIDED|95.0|-17.5|79.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||79.6|-17.5|0.203
71770875|NCT02751931|143041340|OTHER||Mean Difference (Net)|68.47||||0.019|TWO_SIDED|95.0|12.7|124.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||124.2|12.7|0.019
71770876|NCT02751931|143041340|OTHER||Mean Difference (Net)|31.83||||0.042|TWO_SIDED|95.0|1.3|62.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||62.4|1.3|0.042
71770877|NCT02751931|143041340|OTHER||Mean Difference (Net)|38.14||||0.121|TWO_SIDED|95.0|-11.0|87.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||87.3|-11.0|0.121
71770878|NCT02751931|143041341|OTHER||Mean Difference (Net)|0.35||||0.818|TWO_SIDED|95.0|-2.7|3.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||3.4|-2.7|0.818
71770879|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.53||||0.114|TWO_SIDED|95.0|-1.2|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||0.1|-1.2|0.114
71770880|NCT02751931|143041341|OTHER||Mean Difference (Net)|-1.14||||0.052|TWO_SIDED|95.0|-2.3|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||0.0|-2.3|0.052
71770881|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.87||||0.066|TWO_SIDED|95.0|-1.8|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||0.1|-1.8|0.066
71770882|NCT02751931|143041341|OTHER||Mean Difference (Net)|1.16||||0.674|TWO_SIDED|95.0|-4.4|6.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||6.7|-4.4|0.674
71770883|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.65||||0.278|TWO_SIDED|95.0|-1.9|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||0.6|-1.9|0.278
71770884|NCT02751931|143041341|OTHER||Mean Difference (Net)|0.37||||0.871|TWO_SIDED|95.0|-4.2|5.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||5.0|-4.2|0.871
71770885|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.65||||0.153|TWO_SIDED|95.0|-1.6|0.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||0.3|-1.6|0.153
71770886|NCT02751931|143041341|OTHER||Mean Difference (Net)|0.18||||0.922|TWO_SIDED|95.0|-3.5|3.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||3.9|-3.5|0.922
71770887|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.75||||0.047|TWO_SIDED|95.0|-1.5|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||0.0|-1.5|0.047
71770888|NCT02751931|143041341|OTHER||Mean Difference (Net)|-1.98||||0.018|TWO_SIDED|95.0|-3.6|-0.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||-0.4|-3.6|0.018
71770889|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.81||||0.07|TWO_SIDED|95.0|-1.7|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||0.1|-1.7|0.070
71770890|NCT02751931|143041341|OTHER||Mean Difference (Net)|-0.94||||0.083|TWO_SIDED|95.0|-2.0|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.1|-2.0|0.083
71770891|NCT02751931|143041341|OTHER||Mean Difference (Net)|-1.12||||0.064|TWO_SIDED|95.0|-2.3|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.1|-2.3|0.064
71770892|NCT02751931|143041342|OTHER|||||||0.692||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||||0.692
71658039|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.9||||0.157|TWO_SIDED|95.0|-14.09|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||2.30|-14.09|0.157
71658040|NCT02504671|142831750|OTHER||Mean Difference (Net)|-9.37||||0.088|TWO_SIDED|95.0|-20.15|1.42||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||1.42|-20.15|0.088
71830820|NCT00722046|143166750|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|5.64||0.9743|TWO_SIDED|90.0|-9.59|9.22|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||9.22|-9.59|0.9743
71830821|NCT00722046|143166750|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|5.65||0.8824|TWO_SIDED|90.0|-8.57|10.25|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.25|-8.57|0.8824
71830822|NCT00722046|143166750|SUPERIORITY||LS Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|5.81||0.4831|TWO_SIDED|90.0|-13.77|5.58|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||5.58|-13.77|0.4831
71830823|NCT00722046|143166750|SUPERIORITY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|5.88||0.9562|TWO_SIDED|90.0|-9.48|10.13|||Mixed Models Analysis|||Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.||10.13|-9.48|0.9562
71830824|NCT02731755|143166760|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||Between time points and treatments, calculated p value||||0.5
71830825|NCT02731755|143166761|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Ach-iAUC||||0.04
71830826|NCT02731755|143166761|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||SNP-IAUC||||0.007
71830827|NCT02731755|143166761|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Ach - AUC||||0.02
71830828|NCT02731755|143166762|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
71830829|NCT02731755|143166764|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.7
71830830|NCT04425629|143166771|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.1|=|0.0006|TWO_SIDED|95.0|-0.52|-0.14|||ANCOVA|||||-0.14|-0.52|= 0.0006
71830831|NCT04425629|143166771|SUPERIORITY||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||||-0.19|-0.56|< 0.0001
71830832|NCT04425629|143166772|SUPERIORITY||||||=|0.0024|||||||Cochran-Mantel-Haenszel|||||||= 0.0024
71830833|NCT04425629|143166773|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
71830834|NCT04425629|143166779|SUPERIORITY||||||=|0.1903|||||||Mixed Models Analysis|||||||= 0.1903
71830835|NCT04425629|143166779|SUPERIORITY||||||=|0.8431|||||||Mixed Models Analysis|||||||= 0.8431
71830836|NCT04425629|143166835|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.06|16.12||||||||16.12|0.06|
71830837|NCT04425629|143166836|SUPERIORITY||Hazard Ratio (HR)|0.33|||||TWO_SIDED|95.0|0.03|3.13||||||||3.13|0.03|
71830838|NCT00414544|143166865|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was tested.|Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.6|||TWO_SIDED|90.0|-2.0|1.0|||Confidence interval|The 90% lower confidence bound of the difference between CosmetaLife and Restylane were computed.|The confidence interval is built around the mean difference of the two reporting groups.|The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.||1.0|-2.0|
71830839|NCT00373386|143166868|SUPERIORITY_OR_OTHER|||||||0.644|||||||t-test, 2 sided|||compared with baseline||||0.644
71830840|NCT00373386|143166869|SUPERIORITY_OR_OTHER|||||||0.018||||||Versus baseline|t-test, 2 sided|paired||Compared with baseline||||0.018
71830841|NCT00373386|143166870|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison to baseline||||0.04
71830842|NCT00373386|143166871|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison with baseline||||0.004
71830843|NCT00373386|143166872|SUPERIORITY_OR_OTHER|||||||0.804|||||||t-test, 2 sided|||Comparison with baseline||||0.804
71830844|NCT00373386|143166873|SUPERIORITY_OR_OTHER|||||||0.095|||||||t-test, 2 sided|||Comparison with baseline||||0.095
71830845|NCT00373386|143166874|SUPERIORITY_OR_OTHER|||||||0.648|||||||t-test, 2 sided|||Comparison with baseline||||0.648
71658041|NCT02504671|142831750|OTHER||Mean Difference (Net)|-15.12||||0.004|TWO_SIDED|95.0|-25.4|-4.83||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.83|-25.40|0.004
71658042|NCT02504671|142831750|OTHER||Mean Difference (Net)|-14.91||||0.004|TWO_SIDED|95.0|-25.01|-4.8||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-4.80|-25.01|0.004
71830846|NCT03538717|143166879|SUPERIORITY|||||||0.113|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.113
71830847|NCT03538717|143166880|SUPERIORITY|||||||0.228|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.228
71830848|NCT03538717|143166881|SUPERIORITY|||||||0.02|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.020
71830849|NCT03538717|143166882|SUPERIORITY|||||||0.138|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.138
71830850|NCT03538717|143166883|SUPERIORITY|||||||0.524|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.524
71830851|NCT03538717|143166884|SUPERIORITY|||||||0.265|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.265
71830852|NCT03538717|143166885|SUPERIORITY|||||||0.035|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.035
71830853|NCT03538717|143166886|SUPERIORITY|||||||0.123|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.123
71888542|NCT00778830|143298009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3176|||||TWO_SIDED|95.0|0.8078|2.1491||||||||2.1491|0.8078|
71888543|NCT01734655|143298037|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
71888544|NCT01734655|143298038|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
71888545|NCT01734655|143298039|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||correlation analysis|||||||<.01
71888546|NCT01097629|143298068|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.3|||<|1e-05|TWO_SIDED|95.0|18.3|34.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.3|18.3|<0.00001
71658043|NCT02504671|142831750|OTHER||Mean Difference (Net)|-3.89||||0.06|TWO_SIDED|95.0|-7.96|0.17||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||0.17|-7.96|0.060
71658044|NCT02504671|142831750|OTHER||Mean Difference (Net)|-7.39|||<|0.001|TWO_SIDED|95.0|-11.42|-3.36||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI|||-3.36|-11.42|<0.001
71888547|NCT01097629|143298069|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|25.1|||<|1e-05||95.0|16.0|34.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||34.2|16.0|<0.00001
71658045|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.1||||0.016|TWO_SIDED|95.0|-11.06|-1.14||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.14|-11.06|0.016
71658046|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.85||||0.007|TWO_SIDED|95.0|-11.78|-1.91||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI|||-1.91|-11.78|0.007
71658047|NCT02504671|142831750|OTHER||Mean Difference (Net)|-7.92||||0.005|TWO_SIDED|95.0|-13.48|-2.37||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-2.37|-13.48|0.005
71658048|NCT02504671|142831750|OTHER||Mean Difference (Net)|-12.19|||<|0.001|TWO_SIDED|95.0|-17.74|-6.64||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI|||-6.64|-17.74|<0.001
71770893|NCT02751931|143041342|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||||0.018
71770894|NCT02751931|143041342|OTHER|||||||0.061||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||||0.061
71770895|NCT02751931|143041342|OTHER|||||||0.008||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||||0.008
71770896|NCT02751931|143041342|OTHER|||||||0.612||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||||0.612
71770897|NCT02751931|143041342|OTHER|||||||0.018||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||||0.018
71770898|NCT02751931|143041342|OTHER|||||||0.858||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||||0.858
71770899|NCT02751931|143041342|OTHER|||||||0.004||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||||0.004
71770900|NCT02751931|143041342|OTHER|||||||0.003||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||||0.003
71770901|NCT02751931|143041342|OTHER||||||<|0.001||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||||< 0.001
71770902|NCT02751931|143041342|OTHER|||||||0.045||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||||0.045
71770903|NCT02751931|143041342|OTHER|||||||0.002||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||||0.002
71770904|NCT02751931|143041342|OTHER|||||||0.006||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||||0.006
71770905|NCT02751931|143041342|OTHER|||||||0.007||||||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||||0.007
71770906|NCT02751931|143041343|OTHER||Mean Difference (Net)|0.34||||0.018|TWO_SIDED|95.0|0.1|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children||0.6|0.1|0.018
71888548|NCT01097629|143298070|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.6|-22.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.3|-36.6|<0.00001
71830854|NCT03538717|143166887|SUPERIORITY|||||||0.327|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.327
71830855|NCT03538717|143166888|SUPERIORITY|||||||0.419|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.419
71830856|NCT03538717|143166889|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.010
71830857|NCT03538717|143166890|SUPERIORITY|||||||0.446|||||||Chi-squared|||100% clear cells||||0.446
71726593|NCT04392141|142967350|EQUIVALENCE|equivalence of mean of LDH between admission and discharge phases|Mean Difference (Final Values)|137.33||||0.006|TWO_SIDED|95.0|38.19|236.46|||t-test, 2 sided|Paired T-test||Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment||236.46|38.19|0.006
71726594|NCT03622112|142967376|SUPERIORITY||Mean Difference (Final Values)|-0.036||||0.437|TWO_SIDED|95.0|-0.126|0.054|||Mixed Models Analysis|||||0.054|-0.126|0.437
71658049|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.62||||0.059|TWO_SIDED|95.0|-11.45|0.21||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||0.21|-11.45|0.059
71726595|NCT03622112|142967376|SUPERIORITY||Mean Difference (Final Values)|-0.054||||0.236|TWO_SIDED|95.0|-0.143|0.035|||Mixed Models Analysis|||||0.035|-0.143|0.236
71726596|NCT03622112|142967376|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.389|TWO_SIDED|95.0|-0.05|0.128|||Mixed Models Analysis|||||0.128|-0.050|0.389
71726597|NCT03622112|142967376|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.094|TWO_SIDED|95.0|-0.013|0.165|||Mixed Models Analysis|||||0.165|-0.013|0.094
71726598|NCT03622112|142967376|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.06|TWO_SIDED|95.0|-0.003|0.167|||Mixed Models Analysis|||||0.167|-0.003|0.060
71726599|NCT03622112|142967376|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.014|TWO_SIDED|95.0|0.023|0.199|||Mixed Models Analysis|||||0.199|0.023|0.014
71726600|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.463|TWO_SIDED|95.0|-0.048|0.105|||Mixed Models Analysis|||Week 2||0.105|-0.048|0.463
71726601|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.576|TWO_SIDED|95.0|-0.055|0.098|||Mixed Models Analysis|||Week 2||0.098|-0.055|0.576
71830858|NCT03538717|143166890|SUPERIORITY|||||||0.596|||||||Chi-squared|||100% non-clear cells||||0.596
71830859|NCT03538717|143166890|SUPERIORITY|||||||0.578|||||||Chi-squared|||Majority component of clear cells||||0.578
71830860|NCT03538717|143166890|SUPERIORITY|||||||0.706|||||||Fisher Exact|||Majority component of non-clear cells||||0.706
71830861|NCT03538717|143166891|SUPERIORITY|||||||0.074|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.074
71830862|NCT03538717|143166892|SUPERIORITY|||||||0.07|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.070
71830863|NCT03538717|143166893|SUPERIORITY|||||||0.091|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.091
71830864|NCT03538717|143166894|SUPERIORITY|||||||0.046|||||||Chi-squared|||Lymph nodes||||0.046
71830865|NCT03538717|143166894|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||CNS||||>0.999
71830866|NCT03538717|143166894|SUPERIORITY|||||||0.026|||||||Chi-squared|||Hepatic||||0.026
71830867|NCT03538717|143166894|SUPERIORITY|||||||0.327|||||||Chi-squared|||Pulmonary||||0.327
71830868|NCT03538717|143166894|SUPERIORITY|||||||0.024|||||||Chi-squared|||Bone||||0.024
71830869|NCT03538717|143166894|SUPERIORITY|||||||0.045|||||||Chi-squared|||Another site of metastasis||||0.045
71830870|NCT03538717|143166895|SUPERIORITY|||||||0.555|||||||Chi-squared|||LDH level \>1.5\*ULN||||0.555
71830871|NCT03538717|143166895|SUPERIORITY||||||<|0.001|||||||Chi-squared|||Hgb levels \<=LLN||||<0.001
71830872|NCT03538717|143166895|SUPERIORITY|||||||0.344|||||||Chi-squared|||Corrected Ca levels \>10 mg/dL||||0.344
71830873|NCT03538717|143166895|SUPERIORITY||||||>|0.999|||||||Chi-squared|||Neutrophil levels \>ULN||||>0.999
71830874|NCT03538717|143166895|SUPERIORITY|||||||0.795|||||||Chi-squared|||Platelet levels \>ULN||||0.795
71830875|NCT03538717|143166895|SUPERIORITY|||||||0.184|||||||Chi-squared|||Neutrophil-to-lymphocyte ratio \<=3||||0.184
71830876|NCT03538717|143166896|SUPERIORITY|||||||0.235|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.||||0.235
71830877|NCT01499654|143167010|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71830878|NCT01499654|143167010|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.67
71830879|NCT01499654|143167011|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71830880|NCT01499654|143167011|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
71830881|NCT01499654|143167012|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71830882|NCT01499654|143167012|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.08
71830883|NCT01499654|143167013|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
71830884|NCT01499654|143167013|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.44
71830885|NCT01395758|143167016|SUPERIORITY|||||||0.5017|||||||Log Rank|||||||0.5017
71658050|NCT02504671|142831750|OTHER||Mean Difference (Net)|-10.17|||<|0.001|TWO_SIDED|95.0|-15.97|-4.38||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI|||-4.38|-15.97|<0.001
71658051|NCT02504671|142831750|OTHER||Mean Difference (Net)|-10.37||||0.002|TWO_SIDED|95.0|-16.75|-4.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-4.00|-16.75|0.002
71658052|NCT02504671|142831750|OTHER||Mean Difference (Net)|-13.79|||<|0.001|TWO_SIDED|95.0|-20.18|-7.41||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI|||-7.41|-20.18|<0.001
71658053|NCT02504671|142831750|OTHER||Mean Difference (Net)|-9.67||||0.01|TWO_SIDED|95.0|-17.03|-2.31||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-2.31|-17.03|0.010
71658054|NCT02504671|142831750|OTHER||Mean Difference (Net)|-16.63|||<|0.001|TWO_SIDED|95.0|-23.97|-9.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI|||-9.30|-23.97|<0.001
71658055|NCT02504671|142831750|OTHER||Mean Difference (Net)|-5.53||||0.165|TWO_SIDED|95.0|-13.37|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||2.30|-13.37|0.165
71658056|NCT02504671|142831750|OTHER||Mean Difference (Net)|-8.85||||0.022|TWO_SIDED|95.0|-16.39|-1.32||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI|||-1.32|-16.39|0.022
71658057|NCT02504671|142831750|OTHER||Mean Difference (Net)|-6.55||||0.127|TWO_SIDED|95.0|-14.99|1.89||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||1.89|-14.99|0.127
71726602|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.078||||0.047|TWO_SIDED|95.0|0.001|0.154|||Mixed Models Analysis|||Week 2||0.154|0.001|0.047
71726603|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.009|TWO_SIDED|95.0|0.025|0.179|||Mixed Models Analysis|||Week 2||0.179|0.025|0.009
71658058|NCT02504671|142831750|OTHER||Mean Difference (Net)|-8.67||||0.034|TWO_SIDED|95.0|-16.67|-0.67||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI|||-0.67|-16.67|0.034
71726604|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.006|TWO_SIDED|95.0|0.031|0.178|||Mixed Models Analysis|||Week 2||0.178|0.031|0.006
71726605|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.003|TWO_SIDED|95.0|0.041|0.194|||Mixed Models Analysis|||Week 2||0.194|0.041|0.003
71658059|NCT02504671|142831750|OTHER||Mean Difference (Net)|-15.43||||0.004|TWO_SIDED|95.0|-25.78|-5.07||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-5.07|-25.78|0.004
71658060|NCT02504671|142831750|OTHER||Mean Difference (Net)|-19.88|||<|0.001|TWO_SIDED|95.0|-29.7|-10.06||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI|||-10.06|-29.70|<0.001
71658061|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.01||||0.938|TWO_SIDED|95.0|-0.14|0.16||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.16|-0.14|0.938
71658062|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.0||||0.981|TWO_SIDED|95.0|-0.15|0.15||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.15|-0.15|0.981
71658063|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.01||||0.857|TWO_SIDED|95.0|-0.16|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.14|-0.16|0.857
71658064|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.05||||0.592|TWO_SIDED|95.0|-0.13|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.22|-0.13|0.592
71658065|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.01||||0.917|TWO_SIDED|95.0|-0.16|0.18||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.18|-0.16|0.917
71658066|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.05||||0.545|TWO_SIDED|95.0|-0.23|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.12|-0.23|0.545
71658067|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.04||||0.707|TWO_SIDED|95.0|-0.16|0.24||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.24|-0.16|0.707
71658068|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.05||||0.603|TWO_SIDED|95.0|-0.15|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.26|-0.15|0.603
71658069|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.27|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.27|0.473
71726606|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.685|TWO_SIDED|95.0|-0.068|0.103|||Mixed Models Analysis|||Week 4||0.103|-0.068|0.685
71726607|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.176|TWO_SIDED|95.0|-0.026|0.144|||Mixed Models Analysis|||Week 4||0.144|-0.026|0.176
71726608|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.024|TWO_SIDED|95.0|0.013|0.183|||Mixed Models Analysis|||Week 4||0.183|0.013|0.024
71830886|NCT01395758|143167017|SUPERIORITY|||||||0.4356|||||||Log Rank|||||||0.4356
71830887|NCT00357097|143167026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|||<|0.001||95.0|-5.6|-1.6|||ANCOVA||Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.|||-1.6|-5.6|<0.001
71830888|NCT00262730|143167119|NON_INFERIORITY_OR_EQUIVALENCE|study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.|Hazard Ratio (HR)|0.8|STANDARD_DEVIATION|0.025|>|0.1|TWO_SIDED|95.0|0.8|0.85|||Log Rank|||||0.85|0.8|>.1
71830889|NCT03887650|143167129|SUPERIORITY|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||||||0.127
71830890|NCT03887650|143167130|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||||||.975
71830891|NCT03887650|143167131|SUPERIORITY|||||||0.852||||||PACU pain scores|Wilcoxon (Mann-Whitney)|||||||.852
71830892|NCT03887650|143167131|SUPERIORITY|||||||0.661||||||For (PACU-24) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.661
71830893|NCT03887650|143167131|SUPERIORITY|||||||0.747||||||For (PACU-24 hr.) maximum pain score|Wilcoxon (Mann-Whitney)|||||||.747
71830894|NCT03887650|143167131|SUPERIORITY|||||||0.604||||||For (PACU-24 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.604
71830895|NCT03887650|143167131|SUPERIORITY|||||||0.002||||||(24-48 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.002
71830896|NCT03887650|143167131|SUPERIORITY||||||<|0.01||||||For (24-48 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
71830897|NCT03887650|143167131|SUPERIORITY||||||<|0.01||||||For (24-48 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||<0.01
71830898|NCT03887650|143167131|SUPERIORITY|||||||0.011||||||(48-72 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.011
71830899|NCT03887650|143167131|SUPERIORITY|||||||0.001||||||(48-72 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
71726609|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.106||||0.014|TWO_SIDED|95.0|0.021|0.191|||Mixed Models Analysis|||Week 4||0.191|0.021|0.014
71830900|NCT03887650|143167131|SUPERIORITY|||||||0.003||||||(48-72 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.003
71830901|NCT03887650|143167131|SUPERIORITY|||||||0.23||||||For (72-96 hr) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.230
71830902|NCT03887650|143167131|SUPERIORITY|||||||0.007||||||For (72-96 hr) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.007
71830903|NCT03887650|143167131|SUPERIORITY|||||||0.011||||||For (72-96 hr) average pain scores|Wilcoxon (Mann-Whitney)|||||||.011
71830904|NCT03887650|143167131|SUPERIORITY|||||||0.378||||||For (postoperative day 60) minimum pain scores|Wilcoxon (Mann-Whitney)|||||||.378
71830905|NCT03887650|143167131|SUPERIORITY|||||||0.001||||||For (postoperative day 60) maximum pain scores|Wilcoxon (Mann-Whitney)|||||||.001
71830906|NCT03887650|143167131|SUPERIORITY|||||||0.403||||||For (postoperative day 60) average pain scores|Wilcoxon (Mann-Whitney)|||||||.403
71830907|NCT03887650|143167132|SUPERIORITY|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||||||.112
71830908|NCT03887650|143167133|SUPERIORITY|||||||0.096||||||P-Value for POD4|Fisher Exact|Fisher's Exact for POD4||||||0.096
71830909|NCT03887650|143167133|SUPERIORITY|||||||1||||||For POD60|Chi-squared|Chi-squared for POD60||||||1.0
71830910|NCT03887650|143167134|SUPERIORITY|||||||1||||||Any distress on PACU|Chi-squared|||||||1.0
71830911|NCT03887650|143167134|SUPERIORITY|||||||0.947||||||Postoperative day 2|Chi-squared|||||||.947
71830912|NCT03887650|143167135|SUPERIORITY|||||||0.441||||||Full sensation|Fishers Freeman Halton|||||||.441
71830913|NCT03887650|143167135|SUPERIORITY|||||||0.691||||||First sensation|Fishers Freeman Halton|||||||.691
71830914|NCT03887650|143167136|SUPERIORITY|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
71830915|NCT03887650|143167137|SUPERIORITY|||||||0.011||||||Any movement|Fisher' Freeman Halton|||||||.011
71830916|NCT03887650|143167137|SUPERIORITY|||||||0.536||||||Full movement|Fishers Freeman Halton|||||||.536
71830917|NCT03887650|143167138|SUPERIORITY|||||||0.648||||||MME 0-24|Wilcoxon (Mann-Whitney)|||||||.648
71830918|NCT03887650|143167138|SUPERIORITY|||||||0.285||||||MME24-48|Wilcoxon (Mann-Whitney)|||||||.285
71830919|NCT03887650|143167138|SUPERIORITY|||||||0.122||||||MME48-72|Wilcoxon (Mann-Whitney)|||||||.122
71830920|NCT03887650|143167138|SUPERIORITY|||||||0.367||||||MME 72-120|Wilcoxon (Mann-Whitney)|||||||.367
71830921|NCT01503749|143167140|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71830922|NCT05714696|143167141|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
71830923|NCT05714696|143167142|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||.049
71830924|NCT05714696|143167143|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||.029
71830925|NCT05714696|143167144|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
71830926|NCT05714696|143167145|SUPERIORITY|||||||0.442|||||||t-test, 2 sided|||||||.442
71830927|NCT05714696|143167147|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||||||.527
71830928|NCT05714696|143167148|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||.311
71830929|NCT05714696|143167149|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
71830930|NCT05714696|143167150|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||.005
71830931|NCT00736853|143167155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.221|0.641|||Log Rank|Stratified Log-rank test with the target disease as the stratification factor||||0.641|0.221|0.0001
71830932|NCT01199705|143167182|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.39||||||||1.390||
71830933|NCT01199705|143167182|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.953||||||||0.953||
71830934|NCT01199705|143167182|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.914||||||||0.914||
71830935|NCT01199705|143167184|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||1.204||||||||1.204||
71830936|NCT01199705|143167184|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.834||||||||0.834||
71830937|NCT01199705|143167184|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.802||||||||0.802||
71830938|NCT01622868|143167224|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||The study was designed to see if there is a signal in the 12-week CR rate with the addition of lapatinib to warrant a future phase III trial. Null hypothesis: the 12-week post-WBRT/SRS CR rate is ≤ 5%; alternative hypothesis: the addition of lapatinib will increase that CR rate to at least 20%. 114 eligible participants provide 86% power to detect a 15% absolute increase in CR rate at a significance level of 0.10, using a 1-sided Z-test for the difference of 2 proportions.||||0.97
71830939|NCT01622868|143167225|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||||||0.78
71830940|NCT01622868|143167226|SUPERIORITY|||||||0.78||||||One-sided significance level = 0.10|Z-test|||4 weeks post-RT||||0.78
71658070|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.0||||0.987|TWO_SIDED|95.0|-0.21|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.22|-0.21|0.987
71658071|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.04||||0.713|TWO_SIDED|95.0|-0.25|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.17|-0.25|0.713
71658072|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.1||||0.357|TWO_SIDED|95.0|-0.31|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.11|-0.31|0.357
71658073|NCT02504671|142831751|OTHER||Mean Difference (Final Values)|0.04||||0.748|TWO_SIDED|95.0|-0.19|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.26|-0.19|0.748
71658074|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.11||||0.327|TWO_SIDED|95.0|-0.34|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.11|-0.34|0.327
71658075|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.1||||0.395|TWO_SIDED|95.0|-0.32|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.13|-0.32|0.395
71658076|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.05||||0.71|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.710
71726610|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.006|TWO_SIDED|95.0|0.032|0.196|||Mixed Models Analysis|||Week 4||0.196|0.032|0.006
71830941|NCT01622868|143167226|SUPERIORITY|||||||0.97||||||One-sided significance level = 0.10|Z-test|||12 weeks post-RT||||0.97
71830942|NCT01622868|143167232|SUPERIORITY|||||||1||||||One-sided significance level = 0.10|z-test|||||||1.00
71726611|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.165|||<|0.001|TWO_SIDED|95.0|0.081|0.249|||Mixed Models Analysis|||Week 4||0.249|0.081|< 0.001
71830943|NCT01622868|143167234|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.67|TWO_SIDED|95.0|0.62|1.36||Two-sided significance level = 0.05|Log Rank|||||1.36|0.62|0.67
71830944|NCT02918279|143167263|SUPERIORITY||Treatment difference|-0.22||||0.0022|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA||Liraglutide 3.0 mg - Placebo|Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.||-0.08|-0.37|0.0022
71658077|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.04||||0.74|TWO_SIDED|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.21|-0.30|0.740
71658078|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.11||||0.398|TWO_SIDED|95.0|-0.36|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.14|-0.36|0.398
71658079|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.16||||0.364|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.52|-0.19|0.364
71658080|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.12||||0.503|TWO_SIDED|95.0|-0.23|0.46||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.46|-0.23|0.503
71658081|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.08||||0.647|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.26|-0.42|0.647
71658082|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.02||||0.91|TWO_SIDED|95.0|-0.37|0.33||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.33|-0.37|0.910
71658083|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.08||||0.66|TWO_SIDED|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.26|-0.42|0.660
71658084|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.16||||0.34|TWO_SIDED|95.0|-0.5|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.17|-0.50|0.340
71658085|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.02||||0.902|TWO_SIDED|95.0|-0.34|0.39||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.39|-0.34|0.902
71658086|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.28|-0.42|0.687
71658087|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.09||||0.599|TWO_SIDED|95.0|-0.44|0.25||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.25|-0.44|0.599
71726612|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.707|TWO_SIDED|95.0|-0.072|0.106|||Mixed Models Analysis|||Week 8||0.106|-0.072|0.707
71726613|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.005||||0.904|TWO_SIDED|95.0|-0.083|0.094|||Mixed Models Analysis|||Week 8||0.094|-0.083|0.904
71726614|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.121|TWO_SIDED|95.0|-0.018|0.157|||Mixed Models Analysis|||Week 8||0.157|-0.018|0.121
71726615|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.026|TWO_SIDED|95.0|0.012|0.188|||Mixed Models Analysis|||Week 8||0.188|0.012|0.026
71726616|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.139||||0.001|TWO_SIDED|95.0|0.055|0.224|||Mixed Models Analysis|||Week 8||0.224|0.055|0.001
71726617|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.122||||0.006|TWO_SIDED|95.0|0.035|0.209|||Mixed Models Analysis|||Week 8||0.209|0.035|0.006
71726618|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.007||||0.856|TWO_SIDED|95.0|-0.068|0.081|||Mixed Models Analysis|||Treatment period average||0.081|-0.068|0.856
71726619|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.008||||0.832|TWO_SIDED|95.0|-0.066|0.082|||Mixed Models Analysis|||Treatment period average||0.082|-0.066|0.832
71726620|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.06|TWO_SIDED|95.0|-0.003|0.145|||Mixed Models Analysis|||Treatment period average||0.145|-0.003|0.060
71726621|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.096||||0.011|TWO_SIDED|95.0|0.022|0.17|||Mixed Models Analysis|||Treatment period average||0.170|0.022|0.011
71726622|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.003|TWO_SIDED|95.0|0.039|0.181|||Mixed Models Analysis|||Treatment period average||0.181|0.039|0.003
71726623|NCT03622112|142967377|SUPERIORITY||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.055|0.202|||Mixed Models Analysis|||Treatment period average||0.202|0.055|<0.001
71726624|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.936||||0.322|TWO_SIDED|95.0|0.822|1.067|||Mixed Models Analysis|||Week 2||1.067|0.822|0.322
71726625|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.876||||0.047|TWO_SIDED|95.0|0.768|0.999|||Mixed Models Analysis|||Week 2||0.999|0.768|0.047
71726626|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.842||||0.01|TWO_SIDED|95.0|0.739|0.959|||Mixed Models Analysis|||Week 2||0.959|0.739|0.010
71830945|NCT01641198|143167333|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.59|0.01||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.01|-0.59|<0.05
71830946|NCT01641198|143167333|SUPERIORITY||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|95.0|0.09|0.69||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.69|0.09|<0.05
71830947|NCT01641198|143167333|SUPERIORITY||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.115|<|0.05|TWO_SIDED|95.0|-0.98|-0.39||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.39|-0.98|<0.05
71830948|NCT01641198|143167334|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-0.47|0.13||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.13|-0.47|<0.05
71830949|NCT01641198|143167334|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|0.26|0.85||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||0.85|0.26|<0.05
71830950|NCT01641198|143167334|SUPERIORITY||Mean Difference (Final Values)|-0.725|STANDARD_ERROR_OF_MEAN|0.135|<|0.05|TWO_SIDED|95.0|-1.02|-0.43||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)||-0.43|-1.02|<0.05
71726627|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.825||||0.004|TWO_SIDED|95.0|0.724|0.941|||Mixed Models Analysis|||Week 2||0.941|0.724|0.004
71726628|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.687|||<|0.001|TWO_SIDED|95.0|0.606|0.779|||Mixed Models Analysis|||Week 2||0.779|0.606|<0.001
71726629|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.63|||<|0.001|TWO_SIDED|95.0|0.553|0.719|||Mixed Models Analysis|||Week 2||0.719|0.553|<0.001
71726630|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.931||||0.329|TWO_SIDED|95.0|0.805|1.076|||Mixed Models Analysis|||Week 4||1.076|0.805|0.329
71726631|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.911||||0.203|TWO_SIDED|95.0|0.789|1.052|||Mixed Models Analysis|||Week 4||1.052|0.789|0.203
71726632|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.923||||0.273|TWO_SIDED|95.0|0.8|1.065|||Mixed Models Analysis|||Week 4||1.065|0.800|0.273
71726633|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.846||||0.023|TWO_SIDED|95.0|0.734|0.977|||Mixed Models Analysis|||Week 4||0.977|0.734|0.023
71726634|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.742|||<|0.001|TWO_SIDED|95.0|0.646|0.852|||Mixed Models Analysis|||Week 4||0.852|0.646|<0.001
71726635|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.703|||<|0.001|TWO_SIDED|95.0|0.609|0.81|||Mixed Models Analysis|||Week 4||0.810|0.609|<0.001
71726636|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.917||||0.283|TWO_SIDED|95.0|0.783|1.074|||Mixed Models Analysis|||Week 8||1.074|0.783|0.283
71726637|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.933||||0.386|TWO_SIDED|95.0|0.797|1.092|||Mixed Models Analysis|||Week 8||1.092|0.797|0.386
71726638|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.886||||0.126|TWO_SIDED|95.0|0.758|1.035|||Mixed Models Analysis|||Week 8||1.035|0.758|0.126
71770907|NCT02751931|143041343|OTHER||Mean Difference (Net)|0.82||||0.045|TWO_SIDED|95.0|0.0|1.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents||1.6|0.0|0.045
71830951|NCT01641198|143167335|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-0.19|0.59||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)||0.59|-0.19|<0.05
71830952|NCT01641198|143167335|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|0.45|1.22||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)||1.22|0.45|<0.05
71770908|NCT02751931|143041343|OTHER||Mean Difference (Net)|0.68||||0.013|TWO_SIDED|95.0|0.1|1.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children||1.2|0.1|0.013
71770909|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.36||||0.002|TWO_SIDED|95.0|0.6|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents||2.2|0.6|0.002
71770910|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.14||||0.001|TWO_SIDED|95.0|0.5|1.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children||1.8|0.5|0.001
71770911|NCT02751931|143041343|OTHER||Mean Difference (Net)|2.26|||<|0.001|TWO_SIDED|95.0|1.2|3.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents||3.3|1.2|<0.001
71770912|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.31||||0.001|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children||2.1|0.5|0.001
71770913|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.93|||<|0.001|TWO_SIDED|95.0|0.9|3.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents||3.0|0.9|<0.001
71770914|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.34|||<|0.001|TWO_SIDED|95.0|0.7|2.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||2.0|0.7|<0.001
71770915|NCT02751931|143041343|OTHER||Mean Difference (Net)|2.17|||<|0.001|TWO_SIDED|95.0|1.2|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||3.2|1.2|<0.001
71770916|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.33||||0.002|TWO_SIDED|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children||2.1|0.5|0.002
71658088|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.04||||0.588|TWO_SIDED|95.0|-0.19|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.11|-0.19|0.588
71726639|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.855||||0.05|TWO_SIDED|95.0|0.731|1.0|||Mixed Models Analysis|||Week 8||1.000|0.731|0.050
71726640|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.723|||<|0.001|TWO_SIDED|95.0|0.623|0.84|||Mixed Models Analysis|||Week 8||0.840|0.623|<0.001
71726641|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.642|||<|0.001|TWO_SIDED|95.0|0.55|0.749|||Mixed Models Analysis|||Week 8||0.749|0.550|<0.001
71726642|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.927||||0.359|TWO_SIDED|95.0|0.789|1.09|||Mixed Models Analysis|||Week 12||1.090|0.789|0.359
71770917|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.88|||<|0.001|TWO_SIDED|95.0|1.0|2.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents||2.8|1.0|<0.001
71770918|NCT02751931|143041343|OTHER||Mean Difference (Net)|1.38||||0.002|TWO_SIDED|95.0|0.5|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||2.2|0.5|0.002
71770919|NCT02751931|143041343|OTHER||Mean Difference (Net)|2.14|||<|0.001|TWO_SIDED|95.0|1.1|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||3.2|1.1|<0.001
71770920|NCT02751931|143041344|OTHER||Mean Difference (Net)|2.04||||0.352|TWO_SIDED|95.0|-2.4|6.49||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||6.49|-2.40|0.352
71770921|NCT02751931|143041344|OTHER||Mean Difference (Net)|-4.9||||0.127|TWO_SIDED|95.0|-11.34|1.53||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.53|-11.34|0.127
71726643|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.953||||0.556|TWO_SIDED|95.0|0.813|1.118|||Mixed Models Analysis|||Week 12||1.118|0.813|0.556
71726644|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.869||||0.084|TWO_SIDED|95.0|0.742|1.019|||Mixed Models Analysis|||Week 12||1.019|0.742|0.084
71726645|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.813||||0.011|TWO_SIDED|95.0|0.693|0.953|||Mixed Models Analysis|||Week 12||0.953|0.693|0.011
71726646|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.65|||<|0.001|TWO_SIDED|95.0|0.559|0.757|||Mixed Models Analysis|||Week 12||0.757|0.559|<0.001
71726647|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.623|||<|0.001|TWO_SIDED|95.0|0.533|0.729|||Mixed Models Analysis|||Week 12||0.729|0.533|<0.001
71726648|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.928||||0.231|TWO_SIDED|95.0|0.821|1.049|||Mixed Models Analysis|||Treatment period average||1.049|0.821|0.231
71726649|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.918||||0.17|TWO_SIDED|95.0|0.812|1.037|||Mixed Models Analysis|||Treatment period average||1.037|0.812|0.170
71726650|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.879||||0.039|TWO_SIDED|95.0|0.778|0.994|||Mixed Models Analysis|||Treatment period average||0.994|0.778|0.039
71726651|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.835||||0.004|TWO_SIDED|95.0|0.739|0.943|||Mixed Models Analysis|||Treatment period average||0.943|0.739|0.004
71726652|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.7|||<|0.001|TWO_SIDED|95.0|0.622|0.787|||Mixed Models Analysis|||Treatment period average||0.787|0.622|<0.001
71726653|NCT03622112|142967378|SUPERIORITY||Mean Difference (Final Values)|0.649|||<|0.001|TWO_SIDED|95.0|0.575|0.732|||Mixed Models Analysis|||Treatment period average||0.732|0.575|<0.001
71726654|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|-0.034||||0.519|TWO_SIDED|95.0|-0.139|0.07|||Mixed Models Analysis|||Week 12||0.070|-0.139|0.519
71726655|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|-0.078||||0.141|TWO_SIDED|95.0|-0.181|0.026|||Mixed Models Analysis|||Week 12||0.026|-0.181|0.141
71726656|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.772|TWO_SIDED|95.0|-0.088|0.119|||Mixed Models Analysis|||Week 12||0.119|-0.088|0.772
71726657|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.27|TWO_SIDED|95.0|-0.045|0.162|||Mixed Models Analysis|||Week 12||0.162|-0.045|0.270
71726658|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.592|TWO_SIDED|95.0|-0.072|0.126|||Mixed Models Analysis|||Week 12||0.126|-0.072|0.592
71726659|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.275|TWO_SIDED|95.0|-0.045|0.158|||Mixed Models Analysis|||Week 12||0.158|-0.045|0.275
71726660|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.963|TWO_SIDED|95.0|-0.087|0.083|||Mixed Models Analysis|||Treatment period average||0.083|-0.087|0.963
71726661|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|-0.027||||0.533|TWO_SIDED|95.0|-0.112|0.058|||Mixed Models Analysis|||Treatment period average||0.058|-0.112|0.533
71726662|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.342|TWO_SIDED|95.0|-0.044|0.126|||Mixed Models Analysis|||Treatment period average||0.126|-0.044|0.342
71726663|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.061|TWO_SIDED|95.0|-0.004|0.165|||Mixed Models Analysis|||Treatment period average||0.165|-0.004|0.061
71726664|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.278|TWO_SIDED|95.0|-0.037|0.127|||Mixed Models Analysis|||Treatment period average||0.127|-0.037|0.278
71726665|NCT03622112|142967379|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.079|TWO_SIDED|95.0|-0.009|0.159|||Mixed Models Analysis|||Treatment period average||0.159|-0.009|0.079
71726666|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.153||||0.088|TWO_SIDED|95.0|-0.328|0.023|||Mixed Models Analysis|||Week 12||0.023|-0.328|0.088
71726667|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.257||||0.004|TWO_SIDED|95.0|-0.43|-0.084|||Mixed Models Analysis|||Week 12||-0.084|-0.430|0.004
71726668|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.221||||0.012|TWO_SIDED|95.0|-0.393|-0.049|||Mixed Models Analysis|||Week 12||-0.049|-0.393|0.012
71726669|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.193||||0.029|TWO_SIDED|95.0|-0.366|-0.02|||Mixed Models Analysis|||Week 12||-0.020|-0.366|0.029
71726670|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.269||||0.001|TWO_SIDED|95.0|-0.434|-0.104|||Mixed Models Analysis|||Week 12||-0.104|-0.434|0.001
71726671|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.01|TWO_SIDED|95.0|-0.393|-0.054|||Mixed Models Analysis|||Week 12||-0.054|-0.393|0.010
71726672|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.125||||0.055|TWO_SIDED|95.0|-0.253|0.003|||Mixed Models Analysis|||Treatment period average||0.003|-0.253|0.055
71726673|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.141||||0.029|TWO_SIDED|95.0|-0.268|-0.014|||Mixed Models Analysis|||Treatment period average||-0.014|-0.268|0.029
71726674|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.044|TWO_SIDED|95.0|-0.257|-0.003|||Mixed Models Analysis|||Treatment period average||-0.003|-0.257|0.044
71726675|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.201||||0.002|TWO_SIDED|95.0|-0.328|-0.074|||Mixed Models Analysis|||Treatment period average||-0.074|-0.328|0.002
71726676|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.217|||<|0.001|TWO_SIDED|95.0|-0.339|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.339|<0.001
71726677|NCT03622112|142967380|SUPERIORITY||Mean Difference (Final Values)|-0.179||||0.005|TWO_SIDED|95.0|-0.305|-0.053|||Mixed Models Analysis|||Treatment period average||-0.053|-0.305|0.005
71726678|NCT03622112|142967381|SUPERIORITY||Mean Difference (Final Values)|7.664||||0.097|TWO_SIDED|95.0|-1.403|16.73|||Mixed Models Analysis|||Treatment period average||16.730|-1.403|0.097
71726679|NCT03622112|142967381|SUPERIORITY||Mean Difference (Final Values)|5.981||||0.19|TWO_SIDED|95.0|-2.98|14.941|||Mixed Models Analysis|||Treatment period average||14.941|-2.980|0.190
71726680|NCT03622112|142967381|SUPERIORITY||Mean Difference (Final Values)|9.123||||0.045|TWO_SIDED|95.0|0.195|18.052|||Mixed Models Analysis|||Treatment period average||18.052|0.195|0.045
71726681|NCT03622112|142967381|SUPERIORITY||Mean Difference (Final Values)|15.444|||<|0.001|TWO_SIDED|95.0|6.443|24.445|||Mixed Models Analysis|||Treatment period average||24.445|6.443|<0.001
71726682|NCT03622112|142967381|SUPERIORITY||Mean Difference (Final Values)|16.599|||<|0.001|TWO_SIDED|95.0|8.031|25.167|||Mixed Models Analysis|||Treatment period average||25.167|8.031|<0.001
71726683|NCT03622112|142967381|SUPERIORITY||Mean Difference (Final Values)|10.491||||0.019|TWO_SIDED|95.0|1.726|19.256|||Mixed Models Analysis|||Treatment period average||19.256|1.726|0.019
71726684|NCT03622112|142967382|SUPERIORITY||Mean Difference (Final Values)|2.398||||0.597|TWO_SIDED|95.0|-6.494|11.29|||Mixed Models Analysis|||Treatment period average||11.290|-6.494|0.597
71726685|NCT03622112|142967382|SUPERIORITY||Mean Difference (Final Values)|2.162||||0.629|TWO_SIDED|95.0|-6.623|10.948|||Mixed Models Analysis|||Treatment period average||10.948|-6.623|0.629
71658089|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.09||||0.259|TWO_SIDED|95.0|-0.23|0.06||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI|||0.06|-0.23|0.259
71658090|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.08||||0.358|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.358
71658091|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.09||||0.325|TWO_SIDED|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI|||0.09|-0.26|0.325
71658092|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.07||||0.473|TWO_SIDED|95.0|-0.28|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.13|-0.28|0.473
71658093|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.18||||0.085|TWO_SIDED|95.0|-0.38|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI|||0.02|-0.38|0.085
71658094|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.01||||0.897|TWO_SIDED|95.0|-0.2|0.23||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.23|-0.20|0.897
71726686|NCT03622112|142967382|SUPERIORITY||Mean Difference (Final Values)|3.833||||0.389|TWO_SIDED|95.0|-4.907|12.573|||Mixed Models Analysis|||Treatment period average||12.573|-4.907|0.389
71888549|NCT01097629|143298071|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-29.4|||<|1e-05|TWO_SIDED|95.0|-36.7|-22.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-22.1|-36.7|<0.00001
71658095|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.2||||0.065|TWO_SIDED|95.0|-0.42|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI|||0.01|-0.42|0.065
71658096|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.14||||0.238|TWO_SIDED|95.0|-0.36|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.09|-0.36|0.238
71658097|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.21||||0.071|TWO_SIDED|95.0|-0.44|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI|||0.02|-0.44|0.071
71658098|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.12||||0.34|TWO_SIDED|95.0|-0.38|0.13||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.13|-0.38|0.340
71658099|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.24||||0.059|TWO_SIDED|95.0|-0.49|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI|||0.01|-0.49|0.059
71658100|NCT02504671|142831751|OTHER||Mean Difference (Net)|0.09||||0.607|TWO_SIDED|95.0|-0.26|0.44||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.44|-0.26|0.607
71658101|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.01||||0.959|TWO_SIDED|95.0|-0.34|0.32||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI|||0.32|-0.34|0.959
71658102|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.15||||0.401|TWO_SIDED|95.0|-0.49|0.2||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.20|-0.49|0.401
71726687|NCT03622112|142967382|SUPERIORITY||Mean Difference (Final Values)|10.258||||0.022|TWO_SIDED|95.0|1.456|19.059|||Mixed Models Analysis|||Treatment period average||19.059|1.456|0.022
71726688|NCT03622112|142967382|SUPERIORITY||Mean Difference (Final Values)|11.994||||0.005|TWO_SIDED|95.0|3.571|20.417|||Mixed Models Analysis|||Treatment period average||20.417|3.571|0.005
71726689|NCT03622112|142967382|SUPERIORITY||Mean Difference (Final Values)|6.129||||0.163|TWO_SIDED|95.0|-2.479|14.737|||Mixed Models Analysis|||Treatment period average||14.737|-2.479|0.163
71726690|NCT03622112|142967383|SUPERIORITY||Mean Difference (Final Values)|-0.243||||0.012|TWO_SIDED|95.0|-0.431|-0.054|||Mixed Models Analysis|||Treatment period average||-0.054|-0.431|0.012
71726691|NCT03622112|142967383|SUPERIORITY||Mean Difference (Final Values)|-0.155||||0.108|TWO_SIDED|95.0|-0.344|0.034|||Mixed Models Analysis|||Treatment period average||0.034|-0.344|0.108
71726692|NCT03622112|142967383|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.295|TWO_SIDED|95.0|-0.286|0.087|||Mixed Models Analysis|||Treatment period average||0.087|-0.286|0.295
71658103|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.21||||0.207|TWO_SIDED|95.0|-0.54|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI|||0.12|-0.54|0.207
71658104|NCT02504671|142831751|OTHER||Mean Difference (Net)|-0.08||||0.637|TWO_SIDED|95.0|-0.44|0.27||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.27|-0.44|0.637
71658105|NCT02504671|142831751|OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.53|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI|||0.14|-0.53|0.251
71658106|NCT02504671|142831752|OTHER||Mean Difference (Net)|-2.45||||0.511|TWO_SIDED|95.0|-9.81|4.9||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.90|-9.81|0.511
71658107|NCT02504671|142831752|OTHER||Mean Difference (Net)|-2.76||||0.461|TWO_SIDED|95.0|-10.13|4.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||4.60|-10.13|0.461
71658108|NCT02504671|142831752|OTHER||Mean Difference (Net)|-7.71||||0.039|TWO_SIDED|95.0|-15.03|-0.39||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||-0.39|-15.03|0.039
71658109|NCT02504671|142831752|OTHER||Mean Difference (Net)|-2.92||||0.469|TWO_SIDED|95.0|-10.86|5.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||5.01|-10.86|0.469
71658110|NCT02504671|142831752|OTHER||Mean Difference (Net)|-5.99||||0.133|TWO_SIDED|95.0|-13.82|1.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||1.85|-13.82|0.133
71658111|NCT02504671|142831752|OTHER||Mean Difference (Net)|-7.58||||0.057|TWO_SIDED|95.0|-15.4|0.23||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.23|-15.40|0.057
71658112|NCT02504671|142831752|OTHER||Mean Difference (Net)|-3.03||||0.49|TWO_SIDED|95.0|-11.67|5.61||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||5.61|-11.67|0.490
71726693|NCT03622112|142967383|SUPERIORITY||Mean Difference (Final Values)|-0.308||||0.002|TWO_SIDED|95.0|-0.5|-0.116|||Mixed Models Analysis|||Treatment period average||-0.116|-0.500|0.002
71658113|NCT02504671|142831752|OTHER||Mean Difference (Net)|-9.38||||0.031|TWO_SIDED|95.0|-17.91|-0.86||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-0.86|-17.91|0.031
71658114|NCT02504671|142831752|OTHER||Mean Difference (Net)|-12.21||||0.005|TWO_SIDED|95.0|-20.67|-3.74||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-3.74|-20.67|0.005
71658115|NCT02504671|142831752|OTHER||Mean Difference (Net)|-4.49||||0.345|TWO_SIDED|95.0|-13.83|4.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||4.85|-13.83|0.345
71658116|NCT02504671|142831752|OTHER||Mean Difference (Net)|-8.02||||0.09|TWO_SIDED|95.0|-17.3|1.26||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.26|-17.30|0.090
71658117|NCT02504671|142831752|OTHER||Mean Difference (Net)|-8.36||||0.074|TWO_SIDED|95.0|-17.55|0.83||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||0.83|-17.55|0.074
71658118|NCT02504671|142831752|OTHER||Mean Difference (Net)|-5.61||||0.268|TWO_SIDED|95.0|-15.57|4.34||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||4.34|-15.57|0.268
71658119|NCT02504671|142831752|OTHER||Mean Difference (Net)|-14.57||||0.004|TWO_SIDED|95.0|-24.43|-4.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.70|-24.43|0.004
71658120|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.94||||0.005|TWO_SIDED|95.0|-23.72|-4.16||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-4.16|-23.72|0.005
71658121|NCT02504671|142831752|OTHER||Mean Difference (Net)|-7.02||||0.182|TWO_SIDED|95.0|-17.36|3.32||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||3.32|-17.36|0.182
71658122|NCT02504671|142831752|OTHER||Mean Difference (Net)|-14.15||||0.007|TWO_SIDED|95.0|-24.42|-3.87||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-3.87|-24.42|0.007
71658123|NCT02504671|142831752|OTHER||Mean Difference (Net)|-18.18|||<|0.001|TWO_SIDED|95.0|-28.35|-8.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-8.01|-28.35|<0.001
71658124|NCT02504671|142831752|OTHER||Mean Difference (Net)|-4.89||||0.527|TWO_SIDED|95.0|-20.15|10.36||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||10.36|-20.15|0.527
71726694|NCT03622112|142967383|SUPERIORITY||Mean Difference (Final Values)|-0.308|||<|0.001|TWO_SIDED|95.0|-0.489|-0.126|||Mixed Models Analysis|||Treatment period average||-0.126|-0.489|<0.001
71658125|NCT02504671|142831752|OTHER||Mean Difference (Net)|-15.95||||0.034|TWO_SIDED|95.0|-30.72|-1.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||-1.19|-30.72|0.034
71658126|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.86||||0.062|TWO_SIDED|95.0|-28.42|0.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||0.70|-28.42|0.062
71726695|NCT03622112|142967383|SUPERIORITY||Mean Difference (Final Values)|-0.177||||0.062|TWO_SIDED|95.0|-0.362|0.009|||Mixed Models Analysis|||Treatment period average||0.009|-0.362|0.062
71726696|NCT03622112|142967384|SUPERIORITY||Mean Difference (Final Values)|-9.993|||<|0.001|TWO_SIDED|95.0|-15.795|-4.191|||Mixed Models Analysis|||Treatment period average||-4.191|-15.795|<0.001
71888550|NCT01097629|143298072|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.8||||3e-05|TWO_SIDED|95.0|-18.8|-6.9||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.9|-18.8|0.00003
71726697|NCT03622112|142967384|SUPERIORITY||Mean Difference (Final Values)|-7.972||||0.006|TWO_SIDED|95.0|-13.694|-2.251|||Mixed Models Analysis|||Treatment period average||-2.251|-13.694|0.006
71726698|NCT03622112|142967384|SUPERIORITY||Mean Difference (Final Values)|-4.361||||0.133|TWO_SIDED|95.0|-10.051|1.329|||Mixed Models Analysis|||Treatment period average||1.329|-10.051|0.133
71726699|NCT03622112|142967384|SUPERIORITY||Mean Difference (Final Values)|-7.797||||0.008|TWO_SIDED|95.0|-13.555|-2.04|||Mixed Models Analysis|||Treatment period average||-2.040|-13.555|0.008
71726700|NCT03622112|142967384|SUPERIORITY||Mean Difference (Final Values)|-8.729||||0.002|TWO_SIDED|95.0|-14.195|-3.264|||Mixed Models Analysis|||Treatment period average||-3.264|-14.195|0.002
71726701|NCT03622112|142967384|SUPERIORITY||Mean Difference (Final Values)|-11.622|||<|0.001|TWO_SIDED|95.0|-17.211|-6.034|||Mixed Models Analysis|||Treatment period average||-6.034|-17.211|<0.001
71726702|NCT03622112|142967385|SUPERIORITY||Mean Difference (Final Values)|-0.212|||<|0.001|TWO_SIDED|95.0|-0.329|-0.094|||Mixed Models Analysis|||Treatment period average||-0.094|-0.329|<0.001
71726703|NCT03622112|142967385|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.066|TWO_SIDED|95.0|-0.228|0.007|||Mixed Models Analysis|||Treatment period average||0.007|-0.228|0.066
71726704|NCT03622112|142967385|SUPERIORITY||Mean Difference (Final Values)|-0.139||||0.02|TWO_SIDED|95.0|-0.255|-0.022|||Mixed Models Analysis|||Treatment period average||-0.022|-0.255|0.020
71726705|NCT03622112|142967385|SUPERIORITY||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.35|-0.11|||Mixed Models Analysis|||Treatment period average||-0.110|-0.350|<0.001
71726706|NCT03622112|142967385|SUPERIORITY||Mean Difference (Final Values)|-0.185||||0.001|TWO_SIDED|95.0|-0.298|-0.071|||Mixed Models Analysis|||Treatment period average||-0.071|-0.298|0.001
71726707|NCT03622112|142967385|SUPERIORITY||Mean Difference (Final Values)|-0.206|||<|0.001|TWO_SIDED|95.0|-0.321|-0.09|||Mixed Models Analysis|||Treatment period average||-0.090|-0.321|<0.001
71726708|NCT03622112|142967386|SUPERIORITY||Mean Difference (Final Values)|9.611||||0.026|TWO_SIDED|95.0|1.18|18.042|||Mixed Models Analysis|||Treatment period average||18.042|1.180|0.026
71726709|NCT03622112|142967386|SUPERIORITY||Mean Difference (Final Values)|5.503||||0.2|TWO_SIDED|95.0|-2.927|13.933|||Mixed Models Analysis|||Treatment period average||13.933|-2.927|0.200
71726710|NCT03622112|142967386|SUPERIORITY||Mean Difference (Final Values)|6.787||||0.11|TWO_SIDED|95.0|-1.546|15.119|||Mixed Models Analysis|||Treatment period average||15.119|-1.546|0.110
71726711|NCT03622112|142967386|SUPERIORITY||Mean Difference (Final Values)|10.066||||0.022|TWO_SIDED|95.0|1.461|18.672|||Mixed Models Analysis|||Treatment period average||18.672|1.461|0.022
71658127|NCT02504671|142831752|OTHER||Mean Difference (Net)|-0.69||||0.924|TWO_SIDED|95.0|-14.85|13.47||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||13.47|-14.85|0.924
71726712|NCT03622112|142967386|SUPERIORITY||Mean Difference (Final Values)|8.62||||0.038|TWO_SIDED|95.0|0.489|16.75|||Mixed Models Analysis|||Treatment period average||16.750|0.489|0.038
71726713|NCT03622112|142967386|SUPERIORITY||Mean Difference (Final Values)|7.178||||0.09|TWO_SIDED|95.0|-1.112|15.467|||Mixed Models Analysis|||Treatment period average||15.467|-1.112|0.090
71726714|NCT03622112|142967387|SUPERIORITY||Mean Difference (Final Values)|7.936||||0.123|TWO_SIDED|95.0|-2.16|18.031|||Mixed Models Analysis|||Treatment period average||18.031|-2.160|0.123
71726715|NCT03622112|142967387|SUPERIORITY||Mean Difference (Final Values)|0.977||||0.849|TWO_SIDED|95.0|-9.112|11.065|||Mixed Models Analysis|||Treatment period average||11.065|-9.112|0.849
71726716|NCT03622112|142967387|SUPERIORITY||Mean Difference (Final Values)|-1.242||||0.807|TWO_SIDED|95.0|-11.233|8.748|||Mixed Models Analysis|||Treatment period average||8.748|-11.233|0.807
71726717|NCT03622112|142967387|SUPERIORITY||Mean Difference (Final Values)|11.789||||0.025|TWO_SIDED|95.0|1.488|22.09|||Mixed Models Analysis|||Treatment period average||22.090|1.488|0.025
71726718|NCT03622112|142967387|SUPERIORITY||Mean Difference (Final Values)|7.574||||0.127|TWO_SIDED|95.0|-2.16|17.307|||Mixed Models Analysis|||Treatment period average||17.307|-2.160|0.127
71726719|NCT03622112|142967387|SUPERIORITY||Mean Difference (Final Values)|5.058||||0.318|TWO_SIDED|95.0|-4.874|14.99|||Mixed Models Analysis|||Treatment period average||14.990|-4.874|0.318
71726720|NCT03622112|142967388|SUPERIORITY||Mean Difference (Final Values)|10.45||||0.015|TWO_SIDED|95.0|2.046|18.855|||Mixed Models Analysis|||Treatment period average||18.855|2.046|0.015
71726721|NCT03622112|142967388|SUPERIORITY||Mean Difference (Final Values)|7.192||||0.093|TWO_SIDED|95.0|-1.208|15.592|||Mixed Models Analysis|||Treatment period average||15.592|-1.208|0.093
71726722|NCT03622112|142967388|SUPERIORITY||Mean Difference (Final Values)|8.606||||0.042|TWO_SIDED|95.0|0.298|16.913|||Mixed Models Analysis|||Treatment period average||16.913|0.298|0.042
71726723|NCT03622112|142967388|SUPERIORITY||Mean Difference (Final Values)|11.344||||0.01|TWO_SIDED|95.0|2.773|19.914|||Mixed Models Analysis|||Treatment period average||19.914|2.773|0.010
71726724|NCT03622112|142967388|SUPERIORITY||Mean Difference (Final Values)|10.122||||0.014|TWO_SIDED|95.0|2.021|18.222|||Mixed Models Analysis|||Treatment period average||18.222|2.021|0.014
71726725|NCT03622112|142967388|SUPERIORITY||Mean Difference (Final Values)|10.689||||0.011|TWO_SIDED|95.0|2.424|18.953|||Mixed Models Analysis|||Treatment period average||18.953|2.424|0.011
71726726|NCT03622112|142967399|SUPERIORITY||geometric LSMean ratio|1.01||||0.909|TWO_SIDED|95.0|0.851|1.199|||Mixed Models Analysis|||||1.199|0.851|0.909
71726727|NCT03622112|142967399|SUPERIORITY||geometric LSMean ratio|1.118||||0.218|TWO_SIDED|95.0|0.935|1.336|||Mixed Models Analysis|||||1.336|0.935|0.218
71726728|NCT03622112|142967399|SUPERIORITY||geometric LSMean ratio|1.129||||0.181|TWO_SIDED|95.0|0.944|1.349|||Mixed Models Analysis|||||1.349|0.944|0.181
71770922|NCT02751931|143041344|OTHER||Mean Difference (Net)|1.3||||0.613|TWO_SIDED|95.0|-3.96|6.57||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||6.57|-3.96|0.613
71770923|NCT02751931|143041344|OTHER||Mean Difference (Net)|-6.79||||0.056|TWO_SIDED|95.0|-13.78|0.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||0.20|-13.78|0.056
71770924|NCT02751931|143041345|OTHER||Mean Difference (Net)|0.36||||0.153|TWO_SIDED|95.0|-0.14|0.86||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children||0.86|-0.14|0.153
71770925|NCT02751931|143041345|OTHER||Mean Difference (Net)|0.64||||0.007|TWO_SIDED|95.0|0.19|1.08||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents||1.08|0.19|0.007
71770926|NCT02751931|143041345|OTHER||Mean Difference (Net)|0.42||||0.106|TWO_SIDED|95.0|-0.1|0.93||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children||0.93|-0.10|0.106
71770927|NCT02751931|143041345|OTHER||Mean Difference (Net)|0.95||||0.003|TWO_SIDED|95.0|0.38|1.51||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents||1.51|0.38|0.003
71830953|NCT01641198|143167335|SUPERIORITY||Mean Difference (Final Values)|-0.635|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|95.0|-1.01|-0.26||Statistical analysis was based on the mixed linear model with the level of significance set at p\<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI).||-0.26|-1.01|<0.05
71830954|NCT01068743|143167355|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|101.45|||||TWO_SIDED|90.0|98.17|104.84|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||104.84|98.17|
71830955|NCT01068743|143167355|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.43|||||TWO_SIDED|90.0|99.53|105.42|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf,respectively.||105.42|99.53|
71830956|NCT01068743|143167355|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.23||||||||||||||Geometric least squares means for Treatment A.||||
71830957|NCT01068743|143167355|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|49.94||||||||||||||Geometric least squares means for Treatment B.||||
71830958|NCT01068743|143167355|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|52.71||||||||||||||Geometric least squares means for Treatment C.||||
71770928|NCT02380690|143041364|SUPERIORITY|ECLIPSE was powered to detect an effect size of 0.45.||||||0.981||||||Statistical significance was set at p\<0.05|Regression, Linear|||||||0.981
71770929|NCT02380690|143041365|SUPERIORITY|||||||0.774|||||||Regression, Linear|||||||0.774
71770930|NCT02380690|143041366|SUPERIORITY|Power was based on primary outcome.||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.546.|Regression, Linear|||||||0.999
71770931|NCT02380690|143041367|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.403.|Regression, Linear|||||||0.999
71770932|NCT02380690|143041368|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.452.|Regression, Linear|||||||0.999
71770933|NCT02380690|143041369|SUPERIORITY|||||||0.98||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.243.|Regression, Linear|||||||0.980
71770934|NCT02380690|143041370|SUPERIORITY|||||||0.864||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.133.|Regression, Linear|||||||0.864
71770935|NCT02380690|143041371|SUPERIORITY|||||||0.78||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.102.|Regression, Linear|||||||0.780
71770936|NCT02380690|143041372|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.536.|Regression, Linear|||||||0.999
71770937|NCT02380690|143041373|SUPERIORITY|||||||0.997||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.340.|Regression, Linear|||||||0.997
71726729|NCT03622112|142967399|SUPERIORITY||geometric LSMean ratio|0.984||||0.859|TWO_SIDED|95.0|0.825|1.174|||Mixed Models Analysis|||||1.174|0.825|0.859
71726730|NCT03622112|142967399|SUPERIORITY||geometric LSMean ratio|0.916||||0.285|TWO_SIDED|95.0|0.78|1.077|||Mixed Models Analysis|||||1.077|0.780|0.285
71726731|NCT03622112|142967399|SUPERIORITY||geometric LSMean ratio|0.991||||0.923|TWO_SIDED|95.0|0.831|1.182|||Mixed Models Analysis|||||1.182|0.831|0.923
71726732|NCT03359785|142967455|SUPERIORITY||LS Mean Difference|0.278|STANDARD_ERROR_OF_MEAN|0.376||0.2401|ONE_SIDED|90.0|-0.246||||ANOVA||||||-0.246|0.2401
71726733|NCT03359785|142967455|SUPERIORITY||LS Mean Difference|-0.766|STANDARD_ERROR_OF_MEAN|0.547||0.9053|ONE_SIDED|90.0|-1.513||||ANOVA||||||-1.513|0.9053
71726734|NCT03650803|142967478|OTHER|Significance (alpha) set to 0.05||||||0.046|||||||t-test, 1 sided|||MRF T1 Changes||||0.046
71726735|NCT03650803|142967478|OTHER|Significance (alpha) set to 0.05||||||0.064|||||||t-test, 2 sided|||MRF T2 Changes||||0.064
71726736|NCT03650803|142967479|OTHER|Significance (alpha) set to 0.05||||||0.82|||||||t-test, 2 sided|||MRF T1 relaxation time||||0.820
71726737|NCT03650803|142967479|OTHER|Significance (alpha) set to 0.05||||||0.605|||||||t-test, 2 sided|||MRF T2 relaxation time||||0.605
71726738|NCT04376684|142967511|OTHER||Odds Ratio (OR)|1.32||||0.0456|TWO_SIDED|95.0|0.96|1.82||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.82|0.96|0.0456
71726739|NCT04376684|142967512|OTHER||Odds Ratio (OR)|1.04||||0.8574|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8574
71726740|NCT04376684|142967513|OTHER||Odds Ratio (OR)|0.86||||0.2057|TWO_SIDED|95.0|0.61|1.22||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.22|0.61|0.2057
71726741|NCT04376684|142967514|OTHER||Odds Ratio (OR)|0.79||||0.3061|TWO_SIDED|95.0|0.5|1.24||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.24|0.50|0.3061
71830959|NCT01068743|143167355|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|53.99||||||||||||||Geometric least squares means for Treatment D.||||
71830960|NCT01068743|143167358|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.46|||||TWO_SIDED|90.0|94.68|110.88|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||110.88|94.68|
71726742|NCT04376684|142967515|OTHER||Odds Ratio (OR)|0.91||||0.6665|TWO_SIDED|95.0|0.59|1.41||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.41|0.59|0.6665
71726743|NCT04376684|142967516|OTHER||Hazard Ratio (HR)|0.88||||0.1942|TWO_SIDED|95.0|0.65|1.18||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.18|0.65|0.1942
71726744|NCT04376684|142967517|OTHER||Hazard Ratio (HR)|0.9||||0.5324|TWO_SIDED|95.0|0.65|1.24||p-value is generated from a two-sided test|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.24|0.65|0.5324
71726745|NCT04376684|142967518|OTHER||Odds Ratio (OR)|1.09||||0.2871|TWO_SIDED|95.0|0.8|1.49||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.49|0.80|0.2871
71726746|NCT04376684|142967519|OTHER||Odds Ratio (OR)|1.16||||0.1754|TWO_SIDED|95.0|0.85|1.58||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.58|0.85|0.1754
71726747|NCT04376684|142967520|OTHER||Odds Ratio (OR)|1.29||||0.0616|TWO_SIDED|95.0|0.93|1.79||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.79|0.93|0.0616
71726748|NCT04376684|142967521|OTHER||Odds Ratio (OR)|1.17||||0.183|TWO_SIDED|95.0|0.84|1.63||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.63|0.84|0.1830
71658128|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.17||||0.058|TWO_SIDED|95.0|-26.82|0.48||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||0.48|-26.82|0.058
71658129|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.49||||0.049|TWO_SIDED|95.0|-26.91|-0.08||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.08|-26.91|0.049
71658130|NCT02504671|142831752|OTHER||Mean Difference (Net)|-6.38||||0.445|TWO_SIDED|95.0|-22.84|10.07||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||10.07|-22.84|0.445
71658131|NCT02504671|142831752|OTHER||Mean Difference (Net)|-10.14||||0.205|TWO_SIDED|95.0|-25.87|5.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||5.58|-25.87|0.205
71658132|NCT02504671|142831752|OTHER||Mean Difference (Net)|-12.07||||0.125|TWO_SIDED|95.0|-27.55|3.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||3.41|-27.55|0.125
71658133|NCT02504671|142831752|OTHER||Mean Difference (Net)|-4.93||||0.187|TWO_SIDED|95.0|-12.26|2.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||2.41|-12.26|0.187
71658134|NCT02504671|142831752|OTHER||Mean Difference (Net)|-5.63||||0.13|TWO_SIDED|95.0|-12.93|1.67||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score|||1.67|-12.93|0.130
71658135|NCT02504671|142831752|OTHER||Mean Difference (Net)|-7.85||||0.051|TWO_SIDED|95.0|-15.72|0.03||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||0.03|-15.72|0.051
71726749|NCT04376684|142967522|OTHER||Odds Ratio (OR)|1.51||||0.0831|TWO_SIDED|95.0|0.95|2.39||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.39|0.95|0.0831
71726750|NCT04376684|142967523|OTHER||Odds Ratio (OR)|1.29||||0.2557|TWO_SIDED|95.0|0.83|2.0||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.00|0.83|0.2557
71658136|NCT02504671|142831752|OTHER||Mean Difference (Net)|-10.44||||0.009|TWO_SIDED|95.0|-18.27|-2.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score|||-2.60|-18.27|0.009
71658137|NCT02504671|142831752|OTHER||Mean Difference (Net)|-7.94||||0.068|TWO_SIDED|95.0|-16.47|0.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||0.58|-16.47|0.068
71658138|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.96||||0.001|TWO_SIDED|95.0|-22.47|-5.44||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score|||-5.44|-22.47|0.001
71658139|NCT02504671|142831752|OTHER||Mean Difference (Net)|-7.36||||0.118|TWO_SIDED|95.0|-16.62|1.89||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||1.89|-16.62|0.118
71658140|NCT02504671|142831752|OTHER||Mean Difference (Net)|-12.43||||0.009|TWO_SIDED|95.0|-21.68|-3.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score|||-3.19|-21.68|0.009
71658141|NCT02504671|142831752|OTHER||Mean Difference (Net)|-16.51||||0.001|TWO_SIDED|95.0|-26.38|-6.65||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-6.65|-26.38|0.001
71658142|NCT02504671|142831752|OTHER||Mean Difference (Net)|-20.39|||<|0.001|TWO_SIDED|95.0|-30.27|-10.52||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score|||-10.52|-30.27|<0.001
71658143|NCT02504671|142831752|OTHER||Mean Difference (Net)|-12.0||||0.022|TWO_SIDED|95.0|-22.27|-1.73||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-1.73|-22.27|0.022
71658144|NCT02504671|142831752|OTHER||Mean Difference (Net)|-17.94|||<|0.001|TWO_SIDED|95.0|-28.18|-7.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score|||-7.70|-28.18|<0.001
71658145|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.2||||0.084|TWO_SIDED|95.0|-28.18|1.79||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||1.79|-28.18|0.084
71658146|NCT02504671|142831752|OTHER||Mean Difference (Net)|-11.87||||0.099|TWO_SIDED|95.0|-26.02|2.27||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score|||2.27|-26.02|0.099
71658147|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.91||||0.048|TWO_SIDED|95.0|-27.68|-0.14||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.14|-27.68|0.048
71658148|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.22||||0.048|TWO_SIDED|95.0|-26.32|-0.13||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score|||-0.13|-26.32|0.048
71770938|NCT02380690|143041374|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.384.|Regression, Linear|||||||0.999
71658149|NCT02504671|142831752|OTHER||Mean Difference (Net)|-13.23||||0.102|TWO_SIDED|95.0|-29.11|2.64||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||2.64|-29.11|0.102
71658150|NCT02504671|142831752|OTHER||Mean Difference (Net)|-16.7||||0.03|TWO_SIDED|95.0|-31.79|-1.62||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score|||-1.62|-31.79|0.030
71658151|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.6||||0.683|TWO_SIDED|95.0|-2.31|3.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||3.52|-2.31|0.683
71658152|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.19||||0.03|TWO_SIDED|95.0|0.31|6.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||6.07|0.31|0.030
71658153|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.61||||0.074|TWO_SIDED|95.0|-0.25|5.47||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.47|-0.25|0.074
71658154|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.46||||0.39|TWO_SIDED|95.0|-1.88|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||4.80|-1.88|0.390
71658155|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.42||||0.154|TWO_SIDED|95.0|-0.91|5.75||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.75|-0.91|0.154
71658156|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.73||||0.302|TWO_SIDED|95.0|-1.56|5.02||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS|||5.02|-1.56|0.302
71658157|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.69||||0.521|TWO_SIDED|95.0|-3.5|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.88|-3.50|0.521
71658158|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.28||||0.606|TWO_SIDED|95.0|-3.63|6.2||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.20|-3.63|0.606
71770939|NCT02380690|143041375|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.730.|Regression, Linear|||||||0.999
71770940|NCT02380690|143041376|SUPERIORITY|||||||0.914||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.161.|Regression, Linear|||||||0.914
71770941|NCT02380690|143041377|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.930.|Regression, Linear|||||||0.999
71770942|NCT02380690|143041378|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.379.|Regression, Linear|||||||0.999
71770943|NCT02380690|143041379|SUPERIORITY|||||||0.999||||||Statistical significance was set at p\<0.05. A Sidak adjustment was used to account for multiple comparisons. Unadjusted p-value = 0.969.|Regression, Linear|||||||0.999
71770944|NCT00829933|143041383|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED||||||Chi-squared|||For the incidence of bleeding events, paired comparison between the DU-176b groups was performed using the χ2 test.||||0.429
71770945|NCT00829933|143041383|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Chi-squared|||||||0.077
71770946|NCT00829933|143041383|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||Wilcoxon (Mann-Whitney)|||||8.1|-11.2|
71770947|NCT00829933|143041383|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Chi-squared|||||||0.320
71770948|NCT00829933|143041383|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.4|||||TWO_SIDED|95.0|-7.6|12.3|||Wilcoxon (Mann-Whitney)|||||12.3|-7.6|
71770949|NCT00829933|143041383|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.7|||||TWO_SIDED|95.0|-2.7|18.1|||Wilcoxon (Mann-Whitney)|||||18.1|-2.7|
71770950|NCT02338336|143041389|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71770951|NCT01986933|143041391|SUPERIORITY||Mean Difference (Final Values)|-21.39|STANDARD_ERROR_OF_MEAN|7.02||0.0027|TWO_SIDED|95.0|-35.25|-7.53||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-7.53|-35.25|0.0027
71770952|NCT01986933|143041391|SUPERIORITY||Mean Difference (Final Values)|-41.16|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-55.17|-27.15||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-27.15|-55.17|<0.0001
71770953|NCT01986933|143041391|SUPERIORITY||Mean Difference (Final Values)|-40.39|STANDARD_ERROR_OF_MEAN|6.95|<|0.0001|TWO_SIDED|95.0|-54.11|-26.67||Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons was necessary, and the global 1-sided significance alpha level of 0.025 was maintained.|ANCOVA|||||-26.67|-54.11|<0.0001
71770954|NCT03119701|143041400|SUPERIORITY||Odds Ratio (OR)|1.3||||0.78|TWO_SIDED|95.0|0.21|8.19||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||8.19|0.21|0.78
71770955|NCT03119701|143041401|SUPERIORITY||Odds Ratio (OR)|1.7||||0.57|TWO_SIDED|95.0|0.28|10.52||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||10.52|0.28|0.57
71770956|NCT03119701|143041402|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
71726751|NCT04376684|142967524|OTHER||Odds Ratio (OR)|1.04||||0.856|TWO_SIDED|95.0|0.67|1.61||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.61|0.67|0.8560
71726752|NCT04376684|142967525|OTHER||Odds Ratio (OR)|1.07||||0.7533|TWO_SIDED|95.0|0.69|1.66||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.66|0.69|0.7533
71726753|NCT04376684|142967526|OTHER||Hazard Ratio (HR)|1.12||||0.0959|TWO_SIDED|95.0|0.95|1.32||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.32|0.95|0.0959
71726754|NCT04376684|142967527|OTHER||Hazard Ratio (HR)|1.12||||0.4421|TWO_SIDED|95.0|0.84|1.5||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.50|0.84|0.4421
71726755|NCT04376684|142967528|OTHER||Odds Ratio (OR)|1.14||||0.2814|TWO_SIDED|95.0|0.73|1.8||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.80|0.73|0.2814
71726756|NCT04376684|142967529|OTHER||Odds Ratio (OR)|1.04||||0.3901|TWO_SIDED|95.0|0.77|1.42||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.42|0.77|0.3901
71726757|NCT04376684|142967530|OTHER||Odds Ratio (OR)|1.01||||0.4763|TWO_SIDED|95.0|0.75|1.36||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.36|0.75|0.4763
71726758|NCT04376684|142967531|OTHER||Odds Ratio (OR)|1.14||||0.1973|TWO_SIDED|95.0|0.84|1.56||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.56|0.84|0.1973
71726759|NCT04376684|142967532|OTHER||Odds Ratio (OR)|1.21||||0.1173|TWO_SIDED|95.0|0.88|1.67||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, and both clinical status at Baseline and age group as randomized. Missing data was imputed with monotone discriminant multiple imputation assuming data is missing at random.|||1.67|0.88|0.1173
71726760|NCT04376684|142967533|OTHER||Odds Ratio (OR)|3.98||||0.0037|TWO_SIDED|95.0|1.57|10.13||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||10.13|1.57|0.0037
71726761|NCT04376684|142967534|OTHER||Odds Ratio (OR)|1.26||||0.3581|TWO_SIDED|95.0|0.77|2.06||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||2.06|0.77|0.3581
71726762|NCT04376684|142967535|OTHER||Odds Ratio (OR)|0.99||||0.9621|TWO_SIDED|95.0|0.63|1.54||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.54|0.63|0.9621
71726763|NCT04376684|142967536|OTHER||Odds Ratio (OR)|0.83||||0.4167|TWO_SIDED|95.0|0.54|1.29||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.29|0.54|0.4167
71726764|NCT04376684|142967537|OTHER||Odds Ratio (OR)|0.81||||0.3408|TWO_SIDED|95.0|0.53|1.25||p-value is generated from a two-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||1.25|0.53|0.3408
71726765|NCT04376684|142967538|OTHER||Hazard Ratio (HR)|1.02||||0.425|TWO_SIDED|95.0|0.85|1.23||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.23|0.85|0.4250
71726766|NCT04376684|142967539|OTHER||Hazard Ratio (HR)|1.13||||0.4774|TWO_SIDED|95.0|0.81|1.59||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.59|0.81|0.4774
71726767|NCT04376684|142967540|OTHER||Odds Ratio (OR)|0.4||||0.0119|TWO_SIDED|95.0|0.18|0.89||p-value is from a one-sided test.|Regression, Logistic||Analysis performed using logistic regression adjusted for treatment, age, and both clinical status at Baseline and sex as randomized. Missing data was imputed with monotone logistic multiple imputation assuming data is missing at random.|||0.89|0.18|0.0119
71726768|NCT04376684|142967541|OTHER||Hazard Ratio (HR)|1.02||||0.4404|TWO_SIDED|95.0|0.83|1.24||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.24|0.83|0.4404
71726769|NCT04376684|142967542|OTHER||Hazard Ratio (HR)|1.11||||0.6253|TWO_SIDED|95.0|0.72|1.72||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.72|0.72|0.6253
71726770|NCT04376684|142967543|OTHER||Hazard Ratio (HR)|1.11||||0.1078|TWO_SIDED|95.0|0.94|1.3||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.30|0.94|0.1078
71726771|NCT04376684|142967544|OTHER||Hazard Ratio (HR)|1.11||||0.114|TWO_SIDED|95.0|0.94|1.31||p-value is from a one-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized and age group as randomized.|||1.31|0.94|0.1140
71726772|NCT04376684|142967545|OTHER||Hazard Ratio (HR)|1.06||||0.7084|TWO_SIDED|95.0|0.8|1.4||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.40|0.80|0.7084
71726773|NCT04376684|142967546|OTHER||Hazard Ratio (HR)|1.13||||0.4085|TWO_SIDED|95.0|0.84|1.52||p-value is generated from a two-sided test.|Regression, Cox||Model adjusted analysis performed using a Cox proportional hazards model adjusted by treatment, clinical status at Baseline as randomized, sex as randomized and age.|||1.52|0.84|0.4085
71726774|NCT02950155|142967551|SUPERIORITY||probability ratio|2.48||||0.007|TWO_SIDED|95.0|1.2|5.11|||Fisher Exact|||The primary end-point was analyzed as an intention-to-treat analysis, with Fisher's exact test of the difference in proportion, with α=0·05 to indicate statistically significant difference||5.11|1.20|0.007
71726775|NCT02950155|142967552|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.79|TWO_SIDED|95.0|-4.4|2.1|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||2.1|-4.4|0.79
71726776|NCT02950155|142967553|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.3|0.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||0.8|-3.3|0.34
71726777|NCT02950155|142967554|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.47|TWO_SIDED|95.0|-8.2|3.8|||Wilcoxon (Mann-Whitney)|||Subjects receiving rescue treatment before evaluation being censored (per-protocol analysis)||3.8|-8.2|0.47
71726778|NCT02950155|142967555|SUPERIORITY||probability ratio|1.89||||0.036|TWO_SIDED|95.0|1.04|3.44|||Fisher Exact|||||3.44|1.04|0.036
71726779|NCT02979093|142967562|SUPERIORITY||Mean Difference (Final Values)|0.1697|STANDARD_ERROR_OF_MEAN|0.1025||0.106|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Happy Own vs. Happy Unknown||||0.106
71726780|NCT02979093|142967562|SUPERIORITY||Mean Difference (Final Values)|0.20458|STANDARD_ERROR_OF_MEAN|0.1101||0.0709|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for the Amygdala: Happy Own vs. Happy Unknown infant faces.||||0.0709
71726781|NCT02979093|142967562|SUPERIORITY||Mean Difference (Final Values)|-0.14559|STANDARD_ERROR_OF_MEAN|0.08546||0.0964|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Striatum: Sad Own vs. Sad Unknown infant faces.||||0.0964
71726782|NCT02979093|142967562|SUPERIORITY||Mean Difference (Final Values)|-0.15755|STANDARD_ERROR_OF_MEAN|0.07914||0.0538|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||This analysis is for Amygdala: Sad Own vs. Sad Unknown infant faces.||||0.0538
71726783|NCT02979093|142967563|SUPERIORITY||Mean Difference (Final Values)|0.09778|STANDARD_ERROR_OF_MEAN|0.09687||0.319|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (Addiction vs. Control) and condition (Oxytocin \[OT\] vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs. placebo for Ventromedial prefrontal cortex (vmPFC) for happy own vs. happy unknown infant faces."||||0.319
71726784|NCT02979093|142967563|SUPERIORITY||Mean Difference (Final Values)|-0.15289|STANDARD_ERROR_OF_MEAN|0.10968||0.171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for vmPFC for Happy Own vs. Happy Unknown infant faces."||||0.171
71658159|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.46||||0.32|TWO_SIDED|95.0|-2.41|7.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.32|-2.41|0.320
71726785|NCT02979093|142967563|SUPERIORITY||Mean Difference (Final Values)|-0.20839|STANDARD_ERROR_OF_MEAN|0.08405||0.0179|TWO_SIDED|||||Unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on OT vs placebo for Dorsolateral Prefrontal Cortex (dlPFC) for Sad Own vs. Sad Unknown infant faces."||||0.0179
71726786|NCT02979093|142967563|SUPERIORITY||Mean Difference (Final Values)|0.04315|STANDARD_ERROR_OF_MEAN|0.11827||0.7171|TWO_SIDED|||||unadjusted|Mixed Models Analysis|||"This is a mixed effects model with group (addiction vs. control) and condition (OT vs Placebo).~Both variables were included in the model. The interaction effect was tested but not included in the model. This result focuses on addiction vs. control for dlPFC for Sad Own vs. Sad Unknown infant faces."||||0.7171
71770957|NCT03119701|143041404|SUPERIORITY||||||>|0.999||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||>0.999
71770958|NCT03119701|143041407|SUPERIORITY|||||||0.362||||||The threshold for statistical significance was p = 0.05.|Mantel Haenszel|Exact Mantel-Haenszel Chi-Square Test||||||0.3620
71770959|NCT03119701|143041410|SUPERIORITY||||||<|0.0001||||||Day 2, Day 3, Day 4, Day 5, and Day 6.|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||<.0001
71770960|NCT03119701|143041410|SUPERIORITY|||||||0.13||||||Baseline visit|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.13
71770961|NCT03119701|143041410|SUPERIORITY|||||||0.0035||||||Day 1|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.0035
71726787|NCT01096368|142967582|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.229|TWO_SIDED|90.46|0.627|1.197||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|The study was designed to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 1-sided log-rank test. The planned sample size was 160 subjects per arm. 85 EFS events were needed, which were expected after 8 years of accrual and 2 years of follow-up. At 5% type 1 error, the study had 93% power to detect an increase in 2-year EFS from 75% (RT alone) to 87% (RT+maintenance). The design also incorporated interim analyses for futility and efficacy.||1.197|0.627|0.229
71726788|NCT01096368|142967583|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.172|TWO_SIDED|90.46|0.463|1.238||P-value is one-sided. After adjusting for interim analyses, the a priori threshold for significance for the final analysis is one-sided alpha=0.031.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III. Confidence interval is stage-wise adjusted for multiple interim analyses.|It was planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 1-sided log-rank test using the planned sample size of 160 subjects per arm which was optimized for the EFS outcome. A one-sided significance threshold of 5% was planned for this comparison as well.||1.238|0.463|0.172
71726789|NCT01096368|142967584|SUPERIORITY||Hazard Ratio (HR)|0.701||||0.096|TWO_SIDED|95.0|0.461|1.068||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.068|0.461|0.096
71726790|NCT01096368|142967585|SUPERIORITY||Hazard Ratio (HR)|2.684||||0.041|TWO_SIDED|95.0|1.004|7.175||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of events for Arm II over hazard of events for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by EFS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||7.175|1.004|0.041
71726791|NCT01096368|142967586|SUPERIORITY||Hazard Ratio (HR)|0.547||||0.067|TWO_SIDED|95.0|0.284|1.053||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over death of events for Arm III.|In stratum 1, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||1.053|0.284|0.067
71726792|NCT01096368|142967587|SUPERIORITY||Hazard Ratio (HR)|3.601||||0.094|TWO_SIDED|95.0|0.724|17.902||P-value is two-sided and not adjusted for multiple comparisons for this exploratory subgroup comparison.|Log Rank||Hazard ratio is based on hazard of death for Arm II over hazard of death for Arm III.|In stratum 2, it was also planned to test the superiority of RT+maintenance vs. RT alone as measured by OS using the hazard ratio via a 2-sided log-rank test. A two-sided significance threshold of 5% was planned for this comparison.||17.902|0.724|0.094
71770962|NCT03119701|143041410|SUPERIORITY|||||||0.009||||||Day 9|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.009
71770963|NCT03119701|143041410|SUPERIORITY|||||||0.1||||||Day 13|ANOVA|Repeated measures ANOVA||The lower limit of quantification (LLOQ) is equal 5 ng/ml. Values below the LLOQ were set to LLOQ/2 = 2.5 ng/ml. Values over the upper limit of quantitation (ULOQ) were set to 320 ng/ml.||||0.10
71770964|NCT03119701|143041411|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Patients with an observation below the lower limit of quantification (LLOQ) value at baseline for CD73 were set to have the LLOQ value (LLOQ = 4 ng/ml) at baseline for subgroup determination purposes (2-fold increase in CD73 from baseline). Values below the LLOQ were set to LLOQ/2 = 2 ng/mL.||||0.66
71770965|NCT03119701|143041412|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|Repeated measures ANOVA||Observations of zero were imputed as 1 pg/ml before logarithmic transformation.||||0.3
71770966|NCT04030026|143041435|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|< 0.0001
71830961|NCT01068743|143167358|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|106.24|||||TWO_SIDED|90.0|98.43|114.66|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||114.66|98.43|
71658160|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.5||||0.811|TWO_SIDED|95.0|-4.65|3.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.64|-4.65|0.811
71658161|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.45||||0.83|TWO_SIDED|95.0|-3.65|4.55||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.55|-3.65|0.830
71658162|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.54||||0.795|TWO_SIDED|95.0|-4.61|3.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||3.54|-4.61|0.795
71726793|NCT03070223|142967592|SUPERIORITY||Mean Difference (Net)|-0.1||||0.31|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.10|-0.30|0.31
71726794|NCT03070223|142967594|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.62|TWO_SIDED|95.0|-1.72|2.88|||Regression, Linear||Treatment group difference was estimated using baseline-adjusted linear regression model.|Comparison of Month 24 values||2.88|-1.72|0.62
71726795|NCT03070223|142967595|SUPERIORITY||Mean Difference (Net)|-0.001||||0.61|TWO_SIDED|95.0|-0.007|0.004|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.004|-0.007|0.61
71726796|NCT03070223|142967596|SUPERIORITY||Mean Difference (Net)|-0.028||||0.8|TWO_SIDED|95.0|-0.25|0.19|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.19|-0.25|0.80
71726797|NCT03070223|142967597|SUPERIORITY||Risk Ratio (RR)|1.02||||0.33|TWO_SIDED|95.0|0.98|1.06|||Log-binomial regression using GEE|P-value is from the time and treatment group interaction.|Treatment effect is shown as relative annualized risk of impairment in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.06|0.98|0.33
71726798|NCT03070223|142967598|SUPERIORITY||Mean Difference (Net)|-0.005||||0.18|TWO_SIDED|95.0|-0.013|0.002|||Mixed Models Analysis|P-value is from the time and treatment group interaction.|Treatment effect was estimated as the difference in annualized rate of change (slope) with randomized pitavastatin compared to placebo from linear mixed effects models (0 reflects no difference between treatment groups).|||0.002|-0.013|0.18
71726799|NCT03070223|142967599|SUPERIORITY||Risk Ratio (RR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24|||Log-binomial regression using GEE|P-value is from the time (before vs. after study treatment initiation) and treatment group interaction.|Treatment effect is shown as relative average risk of impairment over follow-up time in the pitavastatin group compared to placebo (1 reflects no difference between treatment groups).|||1.24|0.91|0.47
71830962|NCT01068743|143167358|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.73||||||||||||||Geometric least squares means for Treatment A.||||
71726800|NCT03070223|142967604|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.55|TWO_SIDED|95.0|-2.7|1.4|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.4|-2.7|0.55
71726801|NCT03070223|142967605|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.67|TWO_SIDED|95.0|-2.8|1.8|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||1.8|-2.8|0.67
71726802|NCT03070223|142967606|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.5|0.52|||Regression, Linear||Treatment group difference (pitavastatin minus placebo) at Month 24 was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.52|-0.50|0.98
71830963|NCT01068743|143167358|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|9.97||||||||||||||Geometric least squares means for Treatment B.||||
71726803|NCT03070223|142967607|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.31|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.3|-0.8|0.31
71726804|NCT03070223|142967608|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.21|TWO_SIDED|95.0|-0.2|0.9|||Regression, Linear||Treatment group difference at Month 24 (pitavastatin minus placebo) was estimated using baseline-adjusted linear regression model (0 reflects no difference between treatment groups).|Comparison of Month 24 values||0.9|-0.2|0.21
71726805|NCT02308163|142967610|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.58||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.58|1.76|<0.001
71726806|NCT02308163|142967610|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.001|TWO_SIDED|95.0|3.56|12.2||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.20|3.56|<0.001
71726807|NCT02308163|142967612|SUPERIORITY||Odds Ratio (OR)|4.79|||<|0.001|TWO_SIDED|95.0|2.14|10.75||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.75|2.14|<0.001
71726808|NCT02308163|142967612|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|3.53|17.5||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.50|3.53|<0.001
71830964|NCT01068743|143167358|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.33||||||||||||||Geometric least squares means for Treatment C.||||
71830965|NCT01068743|143167358|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|10.97||||||||||||||Geometric least squares means for Treatment D.||||
71658163|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.32||||0.548|TWO_SIDED|95.0|-3.0|5.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.64|-3.00|0.548
71658164|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.46||||0.505|TWO_SIDED|95.0|-2.85|5.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.77|-2.85|0.505
71658165|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.12||||0.605|TWO_SIDED|95.0|-3.15|5.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||5.39|-3.15|0.605
71658166|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.43||||0.895|TWO_SIDED|95.0|-6.03|6.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||6.90|-6.03|0.895
71658167|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.29||||0.461|TWO_SIDED|95.0|-3.84|8.42||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||8.42|-3.84|0.461
71658168|NCT02504671|142831753|OTHER||Mean Difference (Net)|-1.05||||0.732|TWO_SIDED|95.0|-7.1|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||4.99|-7.10|0.732
71658169|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.11||||0.941|TWO_SIDED|95.0|-3.11|2.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||2.88|-3.11|0.941
71658170|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.73||||0.013|TWO_SIDED|95.0|0.78|6.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||6.67|0.78|0.013
71658171|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.92||||0.051|TWO_SIDED|95.0|-0.01|5.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain|||5.84|-0.01|0.051
71658172|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.53||||0.403|TWO_SIDED|95.0|-2.07|5.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.12|-2.07|0.403
71658173|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.82||||0.122|TWO_SIDED|95.0|-0.76|6.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||6.40|-0.76|0.122
71658174|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.08||||0.247|TWO_SIDED|95.0|-1.45|5.62||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain|||5.62|-1.45|0.247
71658175|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.85||||0.384|TWO_SIDED|95.0|-3.61|9.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.32|-3.61|0.384
71658176|NCT02504671|142831753|OTHER||Mean Difference (Net)|5.05||||0.105|TWO_SIDED|95.0|-1.07|11.16||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||11.16|-1.07|0.105
71658177|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.21||||0.29|TWO_SIDED|95.0|-2.76|9.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain|||9.17|-2.76|0.290
71658178|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.51||||0.738|TWO_SIDED|95.0|-3.52|2.5||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||2.50|-3.52|0.738
71658179|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.99||||0.513|TWO_SIDED|95.0|-1.99|3.97||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.97|-1.99|0.513
71658180|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.12||||0.934|TWO_SIDED|95.0|-2.83|3.08||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health|||3.08|-2.83|0.934
71658181|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.63||||0.687|TWO_SIDED|95.0|-2.43|3.68||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.68|-2.43|0.687
71658182|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.85||||0.233|TWO_SIDED|95.0|-1.2|4.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||4.91|-1.20|0.233
71658183|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.57||||0.708|TWO_SIDED|95.0|-2.44|3.59||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health|||3.59|-2.44|0.708
71658184|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.29||||0.25|TWO_SIDED|95.0|-2.34|8.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.93|-2.34|0.250
71658185|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.76||||0.307|TWO_SIDED|95.0|-2.57|8.09||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||8.09|-2.57|0.307
71658186|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.53||||0.345|TWO_SIDED|95.0|-2.74|7.79||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health|||7.79|-2.74|0.345
71658187|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.16||||0.95|TWO_SIDED|95.0|-0.19|0.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||0.52|-0.19|0.950
71658188|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.88||||0.664|TWO_SIDED|95.0|-3.11|4.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||4.87|-3.11|0.664
71658189|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.01||||0.994|TWO_SIDED|95.0|-3.99|3.96||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health|||3.96|-3.99|0.994
71658190|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.6||||0.25|TWO_SIDED|95.0|-1.84|7.03||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.03|-1.84|0.250
71658191|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.21||||0.154|TWO_SIDED|95.0|-1.22|7.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||7.64|-1.22|0.154
71658192|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.5||||0.262|TWO_SIDED|95.0|-1.88|6.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health|||6.89|-1.88|0.262
71658193|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.32||||0.693|TWO_SIDED|95.0|-5.28|7.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||7.93|-5.28|0.693
71658194|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.28||||0.302|TWO_SIDED|95.0|-2.98|9.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||9.54|-2.98|0.302
71658195|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.61||||0.844|TWO_SIDED|95.0|-5.54|6.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health|||6.77|-5.54|0.844
71658196|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.66||||0.698|TWO_SIDED|95.0|-2.71|4.04||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.04|-2.71|0.698
71658197|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.38||||0.159|TWO_SIDED|95.0|-0.94|5.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||5.70|-0.94|0.159
71658198|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.53||||0.36|TWO_SIDED|95.0|-1.76|4.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning|||4.83|-1.76|0.360
71658199|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.82||||0.151|TWO_SIDED|95.0|-1.04|6.69||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.69|-1.04|0.151
71658200|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.01||||0.124|TWO_SIDED|95.0|-0.83|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.86|-0.83|0.124
71658201|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.0||||0.12|TWO_SIDED|95.0|-0.79|6.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning|||6.80|-0.79|0.120
71658202|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.64||||0.814|TWO_SIDED|95.0|-5.98|4.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.70|-5.98|0.814
71658203|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.41||||0.873|TWO_SIDED|95.0|-5.49|4.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||4.67|-5.49|0.873
71658204|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.23||||0.928|TWO_SIDED|95.0|-4.8|5.26||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning|||5.26|-4.80|0.928
71658205|NCT02504671|142831753|OTHER||Mean Difference (Net)|-1.29||||0.541|TWO_SIDED|95.0|-5.44|2.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.86|-5.44|0.541
71658206|NCT02504671|142831753|OTHER||Mean Difference (Net)|-1.29||||0.535|TWO_SIDED|95.0|-5.39|2.81||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||2.81|-5.39|0.535
71658207|NCT02504671|142831753|OTHER||Mean Difference (Net)|-1.03||||0.62|TWO_SIDED|95.0|-5.1|3.05||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional|||3.05|-5.10|0.620
71658208|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.34||||0.881|TWO_SIDED|95.0|-4.08|4.76||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.76|-4.08|0.881
71658209|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.66||||0.767|TWO_SIDED|95.0|-3.74|5.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,Role Emotional|||5.07|-3.74|0.767
71658210|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.24||||0.913|TWO_SIDED|95.0|-4.12|4.61||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional|||4.61|-4.12|0.913
71658211|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.91||||0.79|TWO_SIDED|95.0|-5.81|7.63||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||7.63|-5.81|0.790
71658212|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.5||||0.876|TWO_SIDED|95.0|-5.86|6.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||6.87|-5.86|0.876
71726809|NCT02308163|142967614|SUPERIORITY||Odds Ratio (OR)|39.93|||<|0.001|TWO_SIDED|95.0|5.29|301.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: ACR70-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||301.61|5.29|<0.001
71726810|NCT02308163|142967616|SUPERIORITY||LS mean|-1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.41|-0.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.71|-1.41|<0.001
71726811|NCT02308163|142967616|SUPERIORITY||LS mean|-1.55|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.86|-1.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.24|-1.86|<0.001
71726812|NCT02308163|142967618|SUPERIORITY||LS mean|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.67|-1.38|<0.001
71726813|NCT02308163|142967618|SUPERIORITY||LS mean|-1.64|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.96|-1.31||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.31|-1.96|<0.001
71726814|NCT02308163|142967620|SUPERIORITY||LS mean|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-6.8|-2.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.4|-6.8|<0.001
71726815|NCT02308163|142967620|SUPERIORITY||LS mean|-6.1|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-8.1|-4.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-4.0|-8.1|<0.001
71726816|NCT02308163|142967622|SUPERIORITY||LS mean|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.6|-1.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.4|-4.6|<0.001
71726817|NCT02308163|142967622|SUPERIORITY||LS mean|-5.3|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-6.8|-3.9||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-3.9|-6.8|<0.001
71726818|NCT02308163|142967624|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.31|17.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||17.67|2.31|<0.001
71726819|NCT02308163|142967624|SUPERIORITY||Odds Ratio (OR)|10.13|||<|0.001|TWO_SIDED|95.0|3.76|27.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||27.27|3.76|<0.001
71726820|NCT02308163|142967626|SUPERIORITY||Odds Ratio (OR)|21.72||||0.003|TWO_SIDED|95.0|2.83|166.66||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score \< 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.||166.66|2.83|0.003
71726821|NCT02308163|142967628|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.001|TWO_SIDED|95.0|2.74|12.29||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.29|2.74|<0.001
71726822|NCT02308163|142967628|SUPERIORITY||Odds Ratio (OR)|9.66|||<|0.001|TWO_SIDED|95.0|4.57|20.41||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||20.41|4.57|<0.001
71770967|NCT04030026|143041437|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.208|0.431||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.431|0.208|<0.0001
71770968|NCT04030026|143041438|SUPERIORITY||Geometric Mean Ratio|0.47||||0.0087|TWO_SIDED|95.0|0.23|0.717||Mixed-effects model: unstructured, heterogeneous toeplitz and autoregressive covariance matrices. Dependent variable: change from baseline in log-transformed scale of Daytime Cough Frequency. Fixed effects: sequence (arm), period and treatment.|Mixed-effects model|||||0.717|0.230|0.0087
71770969|NCT04030026|143041439|SUPERIORITY|||||||0.0014||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0014
71658213|NCT02504671|142831753|OTHER||Mean Difference (Net)|-1.3||||0.684|TWO_SIDED|95.0|-7.59|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional|||4.99|-7.59|0.684
71658214|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.86||||0.588|TWO_SIDED|95.0|-2.28|4.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||4.01|-2.28|0.588
71658215|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.21|5.0||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.00|-1.21|0.229
71658216|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.41||||0.125|TWO_SIDED|95.0|-0.67|5.49||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical|||5.49|-0.67|0.125
71658217|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.6||||0.736|TWO_SIDED|95.0|-2.92|4.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.12|-2.92|0.736
71658218|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.72||||0.338|TWO_SIDED|95.0|-1.8|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||5.23|-1.80|0.338
71658219|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.92||||0.6|TWO_SIDED|95.0|-2.55|4.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical|||4.40|-2.55|0.600
71658220|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.26||||0.657|TWO_SIDED|95.0|-4.34|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.86|-4.34|0.657
71658221|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.12||||0.965|TWO_SIDED|95.0|-5.41|5.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||5.17|-5.41|0.965
71658222|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.12||||0.675|TWO_SIDED|95.0|-4.14|6.37||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical|||6.37|-4.14|0.675
71658223|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.32||||0.88|TWO_SIDED|95.0|-4.54|3.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||3.89|-4.54|0.880
71658224|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.17||||0.135|TWO_SIDED|95.0|-1.0|7.33||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||7.33|-1.00|0.135
71658225|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.57||||0.785|TWO_SIDED|95.0|-3.56|4.71||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning|||4.71|-3.56|0.785
71658226|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.55||||0.797|TWO_SIDED|95.0|-3.69|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.80|-3.69|0.797
71658227|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-4.23|4.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.23|-4.23|>0.999
71658228|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.28||||0.896|TWO_SIDED|95.0|-3.91|4.46||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning|||4.46|-3.91|0.896
71658229|NCT02504671|142831753|OTHER||Mean Difference (Net)|-2.89||||0.424|TWO_SIDED|95.0|-10.02|4.24||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||4.24|-10.02|0.424
71658230|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.44||||0.898|TWO_SIDED|95.0|-7.16|6.29||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.29|-7.16|0.898
71658231|NCT02504671|142831753|OTHER||Mean Difference (Net)|-3.79||||0.26|TWO_SIDED|95.0|-10.42|2.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||2.84|-10.42|0.260
71658232|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.02||||0.603|TWO_SIDED|95.0|-2.85|4.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||4.90|-2.85|0.603
71770970|NCT04030026|143041439|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0001
71658233|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.56||||0.068|TWO_SIDED|95.0|-0.26|7.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||7.39|-0.26|0.068
71658234|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.63||||0.174|TWO_SIDED|95.0|-1.17|6.43||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||6.43|-1.17|0.174
71658235|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.97||||0.334|TWO_SIDED|95.0|-2.04|5.98||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||5.98|-2.04|0.334
71658236|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.91||||0.153|TWO_SIDED|95.0|-1.09|6.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.91|-1.09|0.153
71658237|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.18||||0.279|TWO_SIDED|95.0|-1.78|6.13||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality|||6.13|-1.78|0.279
71658238|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.94||||0.584|TWO_SIDED|95.0|-5.04|8.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,Vitality|||8.91|-5.04|0.584
71658239|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.15||||0.346|TWO_SIDED|95.0|-3.44|9.73||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.73|-3.44|0.346
71658240|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.97||||0.37|TWO_SIDED|95.0|-3.55|9.48||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.48|-3.55|0.370
71658241|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.94||||0.045|TWO_SIDED|95.0|0.06|5.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||5.83|0.06|0.045
71658242|NCT02504671|142831753|OTHER||Mean Difference (Net)|4.11||||0.006|TWO_SIDED|95.0|1.22|7.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS|||7.01|1.22|0.006
71658243|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.89||||0.264|TWO_SIDED|95.0|-1.44|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||5.23|-1.44|0.264
71658244|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.55||||0.037|TWO_SIDED|95.0|0.22|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS|||6.88|0.22|0.037
71658245|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.16||||0.392|TWO_SIDED|95.0|-2.81|7.14||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||7.14|-2.81|0.392
71658246|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.65||||0.493|TWO_SIDED|95.0|-3.09|6.39||MMRM analysis adjusted for PCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS|||6.39|-3.09|0.493
71658247|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.16||||0.577|TWO_SIDED|95.0|-2.94|5.26||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||5.26|-2.94|0.577
71658248|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.1||||0.964|TWO_SIDED|95.0|-4.01|4.2||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS|||4.20|-4.01|0.964
71658249|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.97||||0.37|TWO_SIDED|95.0|-2.35|6.28||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||6.28|-2.35|0.370
71658250|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.25||||0.138|TWO_SIDED|95.0|-1.05|7.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS|||7.54|-1.05|0.138
71658251|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.36||||0.667|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.667
71658252|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.79||||0.203|TWO_SIDED|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS|||7.56|-4.85|0.203
71658253|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.45||||0.023|TWO_SIDED|95.0|0.49|6.41||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||6.41|0.49|0.023
71658254|NCT02504671|142831753|OTHER||Mean Difference (Net)|5.08|||<|0.001|TWO_SIDED|95.0|2.14|8.03||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain|||8.03|2.14|<0.001
71658255|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.11||||0.249|TWO_SIDED|95.0|-1.49|5.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||5.70|-1.49|0.249
71658256|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.43||||0.059|TWO_SIDED|95.0|-0.13|6.99||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain|||6.99|-0.13|0.059
71658257|NCT02504671|142831753|OTHER||Mean Difference (Net)|4.72||||0.134|TWO_SIDED|95.0|-1.47|10.9||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.90|-1.47|0.134
71658258|NCT02504671|142831753|OTHER||Mean Difference (Net)|5.2||||0.078|TWO_SIDED|95.0|-0.58|10.97||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain|||10.97|-0.58|0.078
71770971|NCT04030026|143041439|SUPERIORITY|||||||0.001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.001
71770972|NCT04030026|143041440|SUPERIORITY|||||||0.0198||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0198
71770973|NCT04030026|143041440|SUPERIORITY|||||||0.0374||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 16||||0.0374
71770974|NCT04030026|143041440|SUPERIORITY|||||||0.2982||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.2982
71770975|NCT04030026|143041441|SUPERIORITY|||||||0.0054||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo)|Student's T-test|||Change from baseline at Day 8||||0.0054
71770976|NCT04030026|143041441|SUPERIORITY||||||<|0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 15||||<0.0001
71770977|NCT04030026|143041441|SUPERIORITY|||||||0.0001||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 21||||0.0001
71658259|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.65||||0.275|TWO_SIDED|95.0|-1.32|4.62||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.62|-1.32|0.275
71658260|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.94||||0.199|TWO_SIDED|95.0|-1.03|4.91||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health|||4.91|-1.03|0.199
71658261|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.69||||0.654|TWO_SIDED|95.0|-2.36|3.74||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||3.74|-2.36|0.654
71658262|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.29||||0.138|TWO_SIDED|95.0|-0.74|5.33||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health|||5.33|-0.74|0.138
71658263|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.77||||0.516|TWO_SIDED|95.0|-3.62|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||7.17|-3.62|0.516
71658264|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.35||||0.198|TWO_SIDED|95.0|-1.77|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health|||8.46|-1.77|0.198
71658265|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.15||||0.941|TWO_SIDED|95.0|-4.15|3.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||3.84|-4.15|0.941
71658266|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.05||||0.979|TWO_SIDED|95.0|-3.94|4.05||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health|||4.05|-3.94|0.979
71658267|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.4||||0.287|TWO_SIDED|95.0|-2.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||6.84|-2.03|0.287
71658268|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.45||||0.125|TWO_SIDED|95.0|-0.96|7.85||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health|||7.85|-0.96|0.125
71658269|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.15||||0.503|TWO_SIDED|95.0|-4.18|8.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Mental health|||8.49|-4.18|0.503
71658270|NCT02504671|142831753|OTHER||Mean Difference (Net)|5.01||||0.099|TWO_SIDED|95.0|-0.96|10.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24,Mental health|||10.98|-0.96|0.099
71770978|NCT04030026|143041442|SUPERIORITY|||||||0.0107||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 9||||0.0107
71770979|NCT04030026|143041442|SUPERIORITY|||||||0.0051||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change for baseline at Day 16||||0.0051
71770980|NCT04030026|143041442|SUPERIORITY|||||||0.1513||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||Change from baseline at Day 22||||0.1513
71770981|NCT04030026|143041443|SUPERIORITY|||||||0.3601||||||Student's T-test was used to evaluate if the difference in mean change from baseline is different between planned treatments (NAL ER vs placebo).|Student's T-test|||||||0.3601
71770982|NCT02478398|143041469|SUPERIORITY||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-3.45|-2.0|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-2.00|-3.45|< 0.001
71770983|NCT02478398|143041470|SUPERIORITY||Difference in LS Mean|-1.86|||<|0.001|TWO_SIDED|95.0|-2.46|-1.27|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-1.27|-2.46|< 0.001
71770984|NCT02478398|143041471|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-1.81|-0.99|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season||||-0.99|-1.81|< 0.001
71770985|NCT02478398|143041472|SUPERIORITY||Mean Difference (Final Values)|-1.84|||<|0.001|TWO_SIDED|95.0|-2.6|-1.08|||Zero-Inflated Log-Normal Model|Model included fixed effects of treatment, baseline asthma, age group, pollen season, and pollen region nested within pollen season||||-1.08|-2.60|< 0.001
71658271|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.88||||0.268|TWO_SIDED|95.0|-1.45|5.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.21|-1.45|0.268
71888551|NCT01097629|143298073|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.2||||3e-05|TWO_SIDED|95.0|-19.4|-7.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-7.0|-19.4|0.00003
71658272|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.45||||0.147|TWO_SIDED|95.0|-0.87|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning|||5.77|-0.87|0.147
71658273|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.87||||0.145|TWO_SIDED|95.0|-0.99|6.73||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||6.73|-0.99|0.145
71658274|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.54||||0.014|TWO_SIDED|95.0|0.97|8.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning|||8.61|0.97|0.014
71658275|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.47||||0.856|TWO_SIDED|95.0|-4.66|5.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.61|-4.66|0.856
71658276|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.65||||0.793|TWO_SIDED|95.0|-4.24|5.55||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning|||5.55|-4.24|0.793
71658277|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.59||||0.778|TWO_SIDED|95.0|-3.51|4.69||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||4.69|-3.51|0.778
71658278|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.6||||0.773|TWO_SIDED|95.0|-4.7|3.5||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional|||3.50|-4.70|0.773
71658279|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.08||||0.631|TWO_SIDED|95.0|-3.34|5.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||5.49|-3.34|0.631
71658280|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.68||||0.23|TWO_SIDED|95.0|-1.71|7.07||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional|||7.07|-1.71|0.230
71658281|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.41||||0.901|TWO_SIDED|95.0|-6.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||6.84|-6.03|0.901
71658282|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.52||||0.412|TWO_SIDED|95.0|-3.54|8.59||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional|||8.59|-3.54|0.412
71658283|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.88||||0.234|TWO_SIDED|95.0|-1.22|4.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||4.98|-1.22|0.234
71658284|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.66||||0.094|TWO_SIDED|95.0|-0.46|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical|||5.77|-0.46|0.094
71658285|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.43||||0.423|TWO_SIDED|95.0|-2.08|4.94||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||4.94|-2.08|0.423
71658286|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.35||||0.061|TWO_SIDED|95.0|-0.16|6.86||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical|||6.86|-0.16|0.061
71658287|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.21||||0.657|TWO_SIDED|95.0|-4.16|6.57||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||6.57|-4.16|0.657
71658288|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.87||||0.737|TWO_SIDED|95.0|-4.22|5.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical|||5.95|-4.22|0.737
71658289|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.95||||0.165|TWO_SIDED|95.0|-1.22|7.11||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.11|-1.22|0.165
71658290|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.4||||0.109|TWO_SIDED|95.0|-0.77|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning|||7.56|-0.77|0.109
71658291|NCT02504671|142831753|OTHER||Mean Difference (Net)|1.98||||0.359|TWO_SIDED|95.0|-2.26|6.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||6.21|-2.26|0.359
71658292|NCT02504671|142831753|OTHER||Mean Difference (Net)|4.35||||0.043|TWO_SIDED|95.0|0.14|8.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning|||8.56|0.14|0.043
71658293|NCT02504671|142831753|OTHER||Mean Difference (Net)|-0.33||||0.923|TWO_SIDED|95.0|-7.15|6.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Social Functioning|||6.49|-7.15|0.923
71658294|NCT02504671|142831753|OTHER||Mean Difference (Net)|0.3||||0.927|TWO_SIDED|95.0|-6.11|6.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning|||6.70|-6.11|0.927
71726823|NCT02308163|142967630|SUPERIORITY||Odds Ratio (OR)|3.24||||0.012|TWO_SIDED|95.0|1.29|8.12||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.12|1.29|0.012
71726824|NCT02308163|142967630|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|96.0|3.42|19.63||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||19.63|3.42|<0.001
71726825|NCT02308163|142967632|SUPERIORITY||LS Mean|-1.112|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.546|-0.679||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-0.679|-1.546|<0.001
71726826|NCT02308163|142967632|SUPERIORITY||LS mean|-1.677|STANDARD_ERROR_OF_MEAN|0.221|<|0.001|TWO_SIDED|95.0|-2.114|-1.241||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.241|-2.114|<0.001
71726827|NCT02308163|142967634|SUPERIORITY||LS mean|-10.9|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-15.95|-5.84||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.84|-15.95|<0.001
71726828|NCT02308163|142967634|SUPERIORITY||LS mean|-21.14|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-26.01|-16.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-16.27|-26.01|<0.001
71658295|NCT02504671|142831753|OTHER||Mean Difference (Net)|4.64||||0.018|TWO_SIDED|95.0|0.82|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality|||8.46|0.82|0.018
71726829|NCT02308163|142967636|SUPERIORITY||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|2.98|14.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||14.83|2.98|<0.001
71770986|NCT02478398|143041473|OTHER||Difference in % estimates|37.61|||<|0.001|TWO_SIDED|95.0|31.82|43.12|||Miettinen & Nurminen|||||43.12|31.82|< 0.001
71770987|NCT02478398|143041474|OTHER||Difference in % estimates|0.39|||=|0.32|TWO_SIDED|95.0|-0.57|1.53|||Miettinen & Nurminen|||||1.53|-0.57|= 0.320
71770988|NCT02478398|143041475|OTHER||Difference in % estimates|0.0|||=|0.996|TWO_SIDED|95.0|-0.92|0.92|||Miettinen & Nurminen|||||0.92|-0.92|= 0.996
71770989|NCT01362595|143041478|OTHER||||||||||||||||||Due to the small sample size, the statistical approach is primarily descriptive in nature.|||
71770990|NCT01083173|143041542|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 24 weeks as compared to baseline||||< 0.0001
71770991|NCT01083173|143041542|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||CD4 cell counts at 48 weeks as compared to baseline||||< 0.0001
71770992|NCT01850602|143041556|NON_INFERIORITY|"Non-Inferiority margin: 1.0 mg/dL~Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less."|Mean Difference (Final Values)|-0.34||||0.02|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||||-0.05|-0.63|0.020
71770993|NCT01857310|143041560|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|2.8|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.7|
71770994|NCT01857310|143041560|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||Adjusted for infertility treatment stratum and study site|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Live birth will be compared using two sided tests conducted at the 0.05 level."||1.09|0.88|
71770995|NCT01857310|143041561|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.2|
71770996|NCT01857310|143041561|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.2|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Semen volume will be compared using two sided tests conducted at the 0.05 level."||0.2|-0.1|
71658296|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.34||||0.087|TWO_SIDED|95.0|-0.49|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Vitality|||7.17|-0.49|0.087
71888552|NCT01097629|143298074|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.1||||4e-05|TWO_SIDED|95.0|-17.8|-6.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.4|-17.8|0.00004
71888553|NCT01097629|143298075|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-3.6||||0.2651|TWO_SIDED|95.0|-10.1|2.8||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||2.8|-10.1|0.26510
71888554|NCT01097629|143298076|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|26.4|||<|1e-05|TWO_SIDED|95.0|19.8|33.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||33.1|19.8|<0.00001
71658297|NCT02504671|142831753|OTHER||Mean Difference (Net)|2.64||||0.193|TWO_SIDED|95.0|-1.35|6.64||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||6.64|-1.35|0.193
71658298|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.97||||0.051|TWO_SIDED|95.0|-0.01|7.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality|||7.95|-0.01|0.051
71658299|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.36||||0.321|TWO_SIDED|95.0|-3.31|10.02||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Vitality|||10.02|-3.31|0.321
71658300|NCT02504671|142831753|OTHER||Mean Difference (Net)|3.13||||0.328|TWO_SIDED|95.0|-3.18|9.44||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality|||9.44|-3.18|0.328
71658301|NCT02504671|142831754|OTHER||Mean Difference (Net)|-0.65||||0.701|TWO_SIDED|95.0|-3.97|2.67||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||2.67|-3.97|0.701
71658302|NCT02504671|142831754|OTHER||Mean Difference (Net)|1.5||||0.37|TWO_SIDED|95.0|-1.79|4.78||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||4.78|-1.79|0.370
71658303|NCT02504671|142831754|OTHER||Mean Difference (Net)|2.55||||0.125|TWO_SIDED|95.0|-0.71|5.81||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||5.81|-0.71|0.125
71658304|NCT02504671|142831754|OTHER||Mean Difference (Net)|1.92||||0.292|TWO_SIDED|95.0|-1.66|5.5||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||5.50|-1.66|0.292
71658305|NCT02504671|142831754|OTHER||Mean Difference (Net)|6.11||||0.163|TWO_SIDED|95.0|-1.04|6.11||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT sscore|||6.11|-1.04|0.163
71658306|NCT02504671|142831754|OTHER||Mean Difference (Net)|3.08||||0.087|TWO_SIDED|95.0|-0.46|6.61||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||6.61|-0.46|0.087
71658307|NCT02504671|142831754|OTHER||Mean Difference (Net)|0.76||||0.808|TWO_SIDED|95.0|-5.4|6.92||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.92|-5.40|0.808
71658308|NCT02504671|142831754|OTHER||Mean Difference (Net)|-0.47||||0.874|TWO_SIDED|95.0|-6.31|5.38||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||5.38|-6.31|0.874
71658309|NCT02504671|142831754|OTHER||Mean Difference (Net)|-0.81||||0.78|TWO_SIDED|95.0|-6.58|4.95||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,FACIT score|||4.95|-6.58|0.780
71658310|NCT02504671|142831754|OTHER||Mean Difference (Net)|3.57||||0.033|TWO_SIDED|95.0|0.29|6.85||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.85|0.29|0.033
71658311|NCT02504671|142831754|OTHER||Mean Difference (Net)|2.81||||0.094|TWO_SIDED|95.0|-0.48|6.1||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score|||6.10|-0.48|0.094
71658312|NCT02504671|142831754|OTHER||Mean Difference (Net)|3.92||||0.032|TWO_SIDED|95.0|0.34|7.49||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||7.49|0.34|0.032
71830966|NCT01068743|143167359|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|102.1|||||TWO_SIDED|90.0|97.26|107.18|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||107.18|97.26|
71830967|NCT01068743|143167359|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.17|||||TWO_SIDED|90.0|96.23|102.21|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.21|96.23|
71830968|NCT01068743|143167359|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11998.0||||||||||||||Geometric least squares mean for Treatment A.||||
71830969|NCT01068743|143167359|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12250.0||||||||||||||Geometric least squares means for Treatment B.||||
71830970|NCT01068743|143167359|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|12036.0||||||||||||||Geometric least squares means for Treatment C.||||
71830971|NCT01068743|143167359|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11937.0||||||||||||||Geometric least squares means for Treatment D.||||
71830972|NCT01068743|143167360|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.5|||||TWO_SIDED|90.0|90.41|109.5|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||109.5|90.41|
71830973|NCT01068743|143167360|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|98.22|||||TWO_SIDED|90.0|94.28|102.32|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||102.32|94.28|
71658313|NCT02504671|142831754|OTHER||Mean Difference (Net)|5.33||||0.004|TWO_SIDED|95.0|1.77|8.89||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score|||8.89|1.77|0.004
71658314|NCT02504671|142831754|OTHER||Mean Difference (Net)|0.73||||0.808|TWO_SIDED|95.0|-5.19|6.64||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||6.64|-5.19|0.808
71658315|NCT02504671|142831754|OTHER||Mean Difference (Net)|1.87||||0.511|TWO_SIDED|95.0|-3.74|7.48||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score|||7.48|-3.74|0.511
71658316|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.07||||0.888|TWO_SIDED|95.0|-1.04|0.9||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.90|-1.04|0.888
71658317|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.5||||0.307|TWO_SIDED|95.0|-1.46|0.46||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.46|-1.46|0.307
71658318|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.99||||0.041|TWO_SIDED|95.0|-1.95|-0.04||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.04|-1.95|0.041
71658319|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.64||||0.191|TWO_SIDED|95.0|-1.6|0.32||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||0.32|-1.60|0.191
71658320|NCT02504671|142831755|OTHER||Mean Difference (Net)|-1.2||||0.014|TWO_SIDED|95.0|-2.16|-0.24||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.24|-2.16|0.014
71658321|NCT02504671|142831755|OTHER||Mean Difference (Net)|-1.39||||0.004|TWO_SIDED|95.0|-2.34|-0.45||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.45|-2.34|0.004
71658322|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.36||||0.656|TWO_SIDED|95.0|-1.94|1.23||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.23|-1.94|0.656
71658323|NCT02504671|142831755|OTHER||Mean Difference (Net)|0.07||||0.928|TWO_SIDED|95.0|-1.43|1.57||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.57|-1.43|0.928
71658324|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.2||||0.788|TWO_SIDED|95.0|-1.68|1.28||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||1.28|-1.68|0.788
71726830|NCT02308163|142967636|SUPERIORITY||Odds Ratio (OR)|10.86|||<|0.001|TWO_SIDED|95.0|4.91|24.03||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||24.03|4.91|<0.001
71726831|NCT02308163|142967638|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.001|TWO_SIDED|95.0|2.38|8.04||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||8.04|2.38|<0.001
71726832|NCT02308163|142967638|SUPERIORITY||Odds Ratio (OR)|16.78|||<|0.001|TWO_SIDED|95.0|7.31|38.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||38.51|7.31|<0.001
71726833|NCT02308163|142967640|SUPERIORITY||Odds Ratio (OR)|4.29||||0.006|TWO_SIDED|95.0|1.52|12.08||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||12.08|1.52|0.006
71726834|NCT02308163|142967640|SUPERIORITY||Odds Ratio, log|11.01|||<|0.001|TWO_SIDED|95.0|4.07|29.74||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.74|4.07|<0.001
71726835|NCT02308163|142967642|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.001||95.0|2.11|6.93||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||6.93|2.11|<0.001
71726836|NCT02308163|142967642|SUPERIORITY||Odds Ratio (OR)|13.65|||<|0.001|TWO_SIDED|95.0|6.39|29.17||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||29.17|6.39|<0.001
71726837|NCT02308163|142967648|SUPERIORITY||LS Mean|-9.94|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-13.66|-6.22||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-6.22|-13.66|<0.001
71726838|NCT02308163|142967648|SUPERIORITY||Odds Ratio (OR)|-14.43|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-17.71|-11.15||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.15|-17.71|<0.001
71726839|NCT02308163|142967652|SUPERIORITY||LS mean|-8.69|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-12.19|-5.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-5.20|-12.19|<0.001
71726840|NCT02308163|142967652|SUPERIORITY||LS mean|-12.83|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-15.96|-9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.71|-15.96|<0.001
71726841|NCT02308163|142967654|SUPERIORITY||LS mean|-15.2|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-21.4|-9.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.00|-21.40|<0.001
71726842|NCT02308163|142967654|SUPERIORITY||LS mean|-23.14|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-28.78|-17.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.51|-28.78|<0.001
71726843|NCT02308163|142967656|SUPERIORITY||LS mean|-16.88|STANDARD_ERROR_OF_MEAN|3.51|<|0.001|TWO_SIDED|95.0|-23.81|-9.95||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-9.95|-23.81|<0.001
71830974|NCT01068743|143167360|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL|1724.4||||||||||||||Geometric least squares means for Treatment A.||||
71830975|NCT01068743|143167360|SUPERIORITY_OR_OTHER||Geometric Least Square Means (ng/mL)|1715.8||||||||||||||Geometric least squares means for Treatment B.||||
71830976|NCT01068743|143167360|SUPERIORITY_OR_OTHER||Geometric Least Square Mean (ng/mL)|1581.4||||||||||||||Geometric least squares means for Treatment C.||||
71830977|NCT01068743|143167360|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1553.2||||||||||||||Geometric least squares means for Treatment D.||||
71658325|NCT02504671|142831755|OTHER||Mean Difference (Net)|-1.26||||0.01|TWO_SIDED|95.0|-2.22|-0.3||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||-0.30|-2.22|0.010
71658326|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.93||||0.059|TWO_SIDED|95.0|-1.89|0.03||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score|||0.03|-1.89|0.059
71658327|NCT02504671|142831755|OTHER||Mean Difference (Net)|-1.44||||0.003|TWO_SIDED|95.0|-2.4|-0.48||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.48|-2.40|0.003
71658328|NCT02504671|142831755|OTHER||Mean Difference (Net)|-1.57||||0.001|TWO_SIDED|95.0|-2.53|-0.62||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score|||-0.62|-2.53|0.001
71658329|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.76||||0.324|TWO_SIDED|95.0|-2.28|0.76||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.76|-2.28|0.324
71658330|NCT02504671|142831755|OTHER||Mean Difference (Net)|-0.58||||0.432|TWO_SIDED|95.0|-2.02|0.87||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score|||0.87|-2.02|0.432
71658331|NCT00667810|142831797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||0.057|TWO_SIDED|95.0|-3.71|0.05||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||0.05|-3.71|0.057
71658332|NCT00667810|142831797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.848|TWO_SIDED|95.0|-1.73|2.1||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||2.10|-1.73|0.848
71658333|NCT00667810|142831798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.459|TWO_SIDED|95.0|-2.48|5.49||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.49|-2.48|0.459
71658334|NCT00667810|142831798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.623|TWO_SIDED|95.0|-3.04|5.07||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.||5.07|-3.04|0.623
71658335|NCT00667810|142831799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.654|TWO_SIDED|95.0|-0.15|0.09|||Mixed Models Analysis|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||0.09|-0.15|0.654
71658336|NCT00667810|142831800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.18||||0.085|TWO_SIDED|95.0|-15.38|1.02|||ANCOVA|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||1.02|-15.38|0.085
71658337|NCT00667810|142831801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.437|TWO_SIDED|95.0|-1.55|3.57|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.57|-1.55|0.437
71830978|NCT01068743|143167365|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|101.43|||||TWO_SIDED|90.0|98.07|104.9|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||104.90|98.07|
71830979|NCT01068743|143167365|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|102.52|||||TWO_SIDED|90.0|99.56|105.57|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||105.57|99.56|
71830980|NCT01068743|143167365|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.15|||||||||||||Geometric least squares means for Treatment A.|||||
71830981|NCT01068743|143167365|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|47.83|||||||||||||Geometric least squares means for Treatment B.|||||
71830982|NCT01068743|143167365|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|50.89|||||||||||||Geometric least squares means for Treatment C.|||||
71830983|NCT01068743|143167365|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|52.17|||||||||||||Geometric least squares means for Treatment D.|||||
71726844|NCT02308163|142967656|SUPERIORITY||LS mean|-23.56|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-29.83|-17.28||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.28|-29.83|<0.001
71726845|NCT02308163|142967658|SUPERIORITY||LS mean|-17.58|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-24.36|-10.81||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.81|-24.36|<0.001
71726846|NCT02308163|142967658|SUPERIORITY||LS mean|-23.9|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-30.24|-17.57||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-17.57|-30.24|<0.001
71726847|NCT02308163|142967660|SUPERIORITY|||||||0.033||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.033
71726848|NCT02308163|142967660|SUPERIORITY|||||||0.035||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo||||0.035
71726849|NCT02308163|142967661|SUPERIORITY||LS mean|-0.34|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.20|-0.48|<0.001
71726850|NCT02308163|142967661|SUPERIORITY||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo||-0.26|-0.53|<0.001
71726851|NCT02308163|142967663|SUPERIORITY||LS mean|6.87|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|3.69|10.05||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||10.05|3.69|<0.001
71726852|NCT02308163|142967663|SUPERIORITY||LS mean|6.98|STANDARD_ERROR_OF_MEAN|1.45|<|0.001|TWO_SIDED|95.0|4.11|9.85||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.85|4.11|<0.001
71726853|NCT02308163|142967665|SUPERIORITY||LS mean|2.89|STANDARD_ERROR_OF_MEAN|1.0||0.004|TWO_SIDED|95.0|0.91|4.87||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||4.87|0.91|0.004
71726854|NCT02308163|142967665|SUPERIORITY||LS mean|3.25|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|1.3|5.19||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.19|1.30|0.001
71726855|NCT02308163|142967667|SUPERIORITY||LS mean|2.27|STANDARD_ERROR_OF_MEAN|1.8||0.21|TWO_SIDED|95.0|-1.29|5.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||5.83|-1.29|0.210
71726856|NCT02308163|142967667|SUPERIORITY||LS mean|6.23|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|2.74|9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||9.71|2.74|<0.001
71726857|NCT02308163|142967669|SUPERIORITY||LS mean|-8.55|STANDARD_ERROR_OF_MEAN|3.81||0.027|TWO_SIDED|95.0|-16.11|-1.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-1.00|-16.11|0.027
71726858|NCT02308163|142967669|SUPERIORITY||LS mean|-10.17|STANDARD_ERROR_OF_MEAN|3.88||0.01|TWO_SIDED|95.0|-17.88|-2.47||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-2.47|-17.88|0.010
71726859|NCT02308163|142967671|SUPERIORITY||LS mean|-20.67|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-30.44|-10.89||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.89|-30.44|<0.001
71726860|NCT02308163|142967671|SUPERIORITY||LS mean|-22.01|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.06|-11.97||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-11.97|-32.06|<0.001
71726861|NCT02308163|142967673|SUPERIORITY||LS mean|-20.22|STANDARD_ERROR_OF_MEAN|5.12|<|0.001|TWO_SIDED|95.0|-30.38|-10.06||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.06|-30.38|<0.001
71726862|NCT02308163|142967673|SUPERIORITY||LS mean|-23.67|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-34.16|-13.17|||Covariance model|No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-13.17|-34.16|<0.001
71658338|NCT00667810|142831801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.423|TWO_SIDED|95.0|-1.54|3.66|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.||3.66|-1.54|0.423
71658339|NCT00667810|142831802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.212|TWO_SIDED|95.0|-3.4|0.76|||Mixed Models Analysis|||||0.76|-3.40|0.212
71658340|NCT00667810|142831802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.725|TWO_SIDED|95.0|-1.76|2.52|||Mixed Models Analysis|||||2.52|-1.76|0.725
71830984|NCT01068743|143167368|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|100.41|||||TWO_SIDED|90.0|95.4|105.68|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|||105.68|95.40|
71830985|NCT01068743|143167368|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.06|||||TWO_SIDED|90.0|96.19|102.02|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|||102.02|96.19|
71830986|NCT01068743|143167368|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11827.0|||||||||||||Geometric least squares means for Treatment A.|||||
71830987|NCT01068743|143167368|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11875.0|||||||||||||Geometric least squares means for Treatment B.|||||
71830988|NCT01068743|143167368|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11845.0|||||||||||||Geometric least squares means for Treatment C.|||||
71830989|NCT01068743|143167368|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*h/mL)|11734.0|||||||||||||Geometric least squares means for Treatment D.|||||
71830990|NCT02528188|143167407|SUPERIORITY||Risk Difference (RD)|2.39||||0.0123|TWO_SIDED|95.0|0.58|4.68|||Exact methods for risk difference|||||4.68|0.58|0.0123
71830991|NCT02528188|143167407|SUPERIORITY||Risk Difference (RD)|5.61|||<|0.0001|TWO_SIDED|95.0|3.55|8.14|||Exact methods for risk difference|||||8.14|3.55|<0.0001
71830992|NCT02528188|143167408|SUPERIORITY||Rate Difference|23.5||||0.0012|TWO_SIDED|95.0|9.3|37.7|||Poisson model for rate difference|||||37.7|9.3|0.0012
71830993|NCT02528188|143167408|SUPERIORITY||Rate Difference|56.7|||<|0.0001|TWO_SIDED|95.0|38.4|74.9|||Poisson model for rate difference|||||74.9|38.4|<0.0001
71830994|NCT02528188|143167409|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.11||0.0148|TWO_SIDED|95.0|-0.46|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.46|0.0148
71830995|NCT02528188|143167409|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1597|TWO_SIDED|95.0|-0.36|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.36|0.1597
71726863|NCT02308163|142967675|SUPERIORITY||LS mean|-17.3|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-24.0|-10.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-10.61|-24.00|<0.001
71770997|NCT01857310|143041562|SUPERIORITY||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.1|-12.5|3.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.9|-12.5|
71770998|NCT01857310|143041562|SUPERIORITY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.1|-13.6|3.1|||||Weighted for loss to follow-up and adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm concentration represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||3.1|-13.6|
71830996|NCT02528188|143167410|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.52|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.11|-0.52|0.0030
71830997|NCT02528188|143167410|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0691|TWO_SIDED|95.0|-0.4|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.40|0.0691
71830998|NCT02528188|143167411|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3431|TWO_SIDED|95.0|-0.11|0.04||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.11|0.3431
71830999|NCT02528188|143167411|SUPERIORITY|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (\>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6332|TWO_SIDED|95.0|-0.09|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.09|0.6332
71831000|NCT02528188|143167412|SUPERIORITY||Risk Difference (RD)|0.5||||0.4082|TWO_SIDED|95.0|-0.75|2.28|||Exact methods for risk difference|||||2.28|-0.75|0.4082
71831001|NCT02528188|143167412|SUPERIORITY||Risk Difference (RD)|1.7||||0.0238|TWO_SIDED|95.0|0.31|3.63|||Exact methods for risk difference|||||3.63|0.31|0.0238
71831002|NCT02528188|143167413|SUPERIORITY||Rate Difference|4.8||||0.2035|TWO_SIDED|95.0|-2.6|12.2|||Poisson model for rate difference|||||12.2|-2.6|0.2035
71831003|NCT02528188|143167413|SUPERIORITY||Rate Difference|16.9||||0.001|TWO_SIDED|95.0|6.8|27.0|||Poisson model for rate difference|||||27.0|6.8|0.0010
71831004|NCT02528188|143167414|SUPERIORITY||Risk Difference|1.99||||0.0248|TWO_SIDED|95.0|0.31|4.17|||Exact methods for risk difference|||Rapidly progressive OA Type 1 or 2||4.17|0.31|0.0248
71888555|NCT01097629|143298077|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-42.0|||<|1e-05|TWO_SIDED|95.0|-48.6|-35.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-35.3|-48.6|<0.00001
71888556|NCT01097629|143298078|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.1|||<|1e-05|TWO_SIDED|95.0|-17.7|-8.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-8.4|-17.7|<0.00001
71658341|NCT00667810|142831803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.149|TWO_SIDED|95.0|-1.15|7.56|||Mixed Models Analysis|||||7.56|-1.15|0.149
71658342|NCT00667810|142831803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01||||0.375|TWO_SIDED|95.0|-2.44|6.46|||Mixed Models Analysis|||||6.46|-2.44|0.375
71658343|NCT00667810|142831804|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not specifed.|Log Rank|||||||0.030
71726864|NCT02308163|142967675|SUPERIORITY||LS mean|-20.41|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-26.59|-14.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo||-14.24|-26.59|<0.001
71726865|NCT02136680|142967729|SUPERIORITY||Regression Coefficient|0.046||||0.4|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.400
71726866|NCT02136680|142967729|SUPERIORITY||Regression Coefficient|0.119||||0.022|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.022
71770999|NCT01857310|143041563|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.1|-2.5|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.5|-2.5|
71771000|NCT01857310|143041563|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.1|-2.7|1.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm motility represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||1.4|-2.7|
71771001|NCT01857310|143041564|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.8|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0.1|-0.8|
71771002|NCT01857310|143041564|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.1|-0.9|0.0|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. The confidence interval for sperm morphology represents 95.1% coverage to properly account for the alpha spent in the interim analysis."||0|-0.9|
71658344|NCT00667810|142831804|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Log Rank|||||||0.567
71658345|NCT00667810|142831805|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Log Rank|||||||0.079
71658346|NCT00667810|142831805|SUPERIORITY_OR_OTHER|||||||0.675|TWO_SIDED||||||Log Rank|||||||0.675
71658347|NCT00667810|142831806|SUPERIORITY_OR_OTHER|||||||0.846|TWO_SIDED||||||Log Rank|||Not spsecified.||||0.846
71658348|NCT00667810|142831806|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Log Rank|||||||0.797
71658349|NCT00667810|142831807|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Log Rank|||||||0.933
71658350|NCT00667810|142831807|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Log Rank|||||||0.714
71658351|NCT00667810|142831809|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.277
71658352|NCT00667810|142831809|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.996
71658353|NCT00667810|142831811|SUPERIORITY_OR_OTHER|||||||0.855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.855
71658354|NCT00667810|142831811|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.423
71658355|NCT00667810|142831812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.516|TWO_SIDED|95.0|-0.65|0.33|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.33|-0.65|0.516
71658356|NCT00667810|142831812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.||0.21|-0.79|0.257
71726867|NCT02136680|142967729|SUPERIORITY||Regression Coefficient|-0.003||||0.347|TWO_SIDED||||||Regression, Linear|||Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.347
71726868|NCT02136680|142967730|SUPERIORITY||Regression Coefficient|-0.003||||0.959|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.959
71726869|NCT02136680|142967730|SUPERIORITY||Regression Coefficient|0.143||||0.021|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.021
71726870|NCT02136680|142967730|SUPERIORITY||Regression Coefficient|0.048||||0.454|TWO_SIDED||||||Regression, Linear|||Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.454
71726871|NCT02136680|142967730|SUPERIORITY||Regression Coefficient|-0.015||||0.774|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to First Follow-up||||0.774
71658357|NCT00667810|142831813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.238|TWO_SIDED|95.0|-0.96|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.24|-0.96|0.238
71658358|NCT00667810|142831813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.564|TWO_SIDED|95.0|-0.78|0.43|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.||0.43|-0.78|0.564
71658359|NCT04442490|142831821|SUPERIORITY||Least Squares (LS) Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0141|TWO_SIDED|95.0|-3.1|-0.3|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||-0.3|-3.1|0.0141
71658360|NCT04442490|142831822|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.1193|TWO_SIDED|95.0|-0.4|0.0|||MMRM||Model used was the MMRM with treatment (SAGE-217 or placebo), baseline CGI-S score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|||0.0|-0.4|0.1193
71658361|NCT04442490|142831823|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|-4.0|-2.0|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 3||-2.0|-4.0|<0.0001
71658362|NCT04442490|142831823|SUPERIORITY||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-3.8|-1.4|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 8||-1.4|-3.8|<0.0001
71658363|NCT04442490|142831823|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.76||0.2344|TWO_SIDED|95.0|-2.4|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from baseline at Day 42||0.6|-2.4|0.2344
71658364|NCT04442490|142831824|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0599|TWO_SIDED|95.0|0.99|1.98|||Generalized Estimating Equation Model|||Day 15|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.98|0.99|0.0599
71658365|NCT04442490|142831824|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0889|TWO_SIDED|95.0|0.95|1.94|||GEE Model|||Day 42|Model used is a GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure.Odds ratio was the estimate of the odds of having HAM-D response for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.94|0.95|0.0889
71658366|NCT04442490|142831825|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5495|TWO_SIDED|95.0|0.76|1.66|||GEE Model|||Day 15|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.66|0.76|0.5495
71831005|NCT02528188|143167414|SUPERIORITY||Risk difference|5.11|||<|0.0001|TWO_SIDED|95.0|3.16|7.54|||Exact methods for risk difference|||Rapidly Progressive OA Type 1 or 2||7.54|3.16|<0.0001
71658367|NCT04442490|142831825|SUPERIORITY||Odds Ratio (OR)|1.09||||0.679|TWO_SIDED|95.0|0.74|1.6|||GEE Model|||Day 42|Model used is GEE for binary response model, with factors for treatment, baseline HAM-D total score, antidepressant use at baseline, assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having HAM-D remission for participants treated with SAGE-217 relative to that for participants treated with placebo.|1.60|0.74|0.6790
71658368|NCT04442490|142831826|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0191|TWO_SIDED|95.0|1.07|2.16|||GEE Model|||Placebo, SAGE-217|Model used was a GEE for binary response model, with factors for treatment, CGI-S baseline score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction with Unstructured covariance structure. Odds ratio was the estimate of the odds of having CGI-I response for participants treated with SAGE-217 relative to that for participants treated with placebo.|2.16|1.07|0.0191
71658369|NCT04442490|142831827|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.05||0.0238|TWO_SIDED|95.0|-4.4|-0.3|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline MADRS total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure|Placebo, SAGE-217||-0.3|-4.4|0.0238
71658370|NCT04442490|142831828|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0199|TWO_SIDED|95.0|-2.5|-0.2|||MMRM||Model used was MMRM with treatment (SAGE-217/placebo), baseline HAM-A total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Placebo, SAGE-217||-0.2|-2.5|0.0199
71658371|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.5||0.3216|TWO_SIDED|95.0|-0.5|1.5|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 8||1.5|-0.5|0.3216
71831006|NCT02528188|143167414|SUPERIORITY||Risk difference|1.79||||0.0366|TWO_SIDED|95.0|0.16|3.92|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||3.92|0.16|0.0366
71831007|NCT02528188|143167414|SUPERIORITY||Risk difference|3.81||||0.0001|TWO_SIDED|95.0|1.99|6.12|||Exact methods for risk difference|||Rapidly Progressive OA Type 1||6.12|1.99|0.0001
71831008|NCT02528188|143167414|SUPERIORITY||Risk difference|0.2||||0.6168|TWO_SIDED|95.0|-0.76|1.71|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||1.71|-0.76|0.6168
71831009|NCT02528188|143167414|SUPERIORITY||Risk difference|1.3||||0.0388|TWO_SIDED|95.0|0.17|2.97|||Exact methods for risk difference|||Rapidly Progressive OA Type 2||2.97|0.17|0.0388
71726872|NCT02136680|142967730|SUPERIORITY||Regression Coefficient|0.137||||0.018|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.018
71726873|NCT02136680|142967730|SUPERIORITY||Regression Coefficient|0.051||||0.362|TWO_SIDED||||||Regression, Linear|||Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group||||0.362
71771003|NCT01857310|143041565|SUPERIORITY||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|0.5|4.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.4|0.5|
71771004|NCT01857310|143041565|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|0.3|4.3|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. DNA fragmentation will be compared using two sided tests conducted at the 0.05 level."||4.3|0.3|
71658372|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1247|TWO_SIDED|95.0|-0.2|1.8|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 15||1.8|-0.2|0.1247
71726874|NCT02136680|142967731|SUPERIORITY||Regression Coefficient|-0.072||||0.213|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Group||||0.213
71658373|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1111|TWO_SIDED|95.0|-0.2|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 28||2.0|-0.2|0.1111
71658374|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.59||0.1449|TWO_SIDED|95.0|-0.3|2.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Physical Functioning Domain Score: Change from Baseline at Day 42||2.0|-0.3|0.1449
71658375|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8242|TWO_SIDED|95.0|-1.3|1.0|||MMRM||Model used is MMRM with treatment(SAGE-217/placebo), baseline SF-36v2 domain/component score, antidepressant use at baseline(Yes/No)assessment time point and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Role-Physical Domain Score: Change from Baseline at Day 8||1.0|-1.3|0.8242
71658376|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8329|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 15||1.1|-1.4|0.8329
71726875|NCT02136680|142967731|SUPERIORITY||Regression Coefficient|0.037||||0.561|TWO_SIDED||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Group||||0.561
71771005|NCT01857310|143041566|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-19.7|22.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||22.5|-19.7|
71658377|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8127|TWO_SIDED|95.0|-1.4|1.1|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 28||1.1|-1.4|0.8127
71658378|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.64||0.5435|TWO_SIDED|95.0|-0.9|1.6|||MMRM|||Role-Physical Domain Score: Change from Baseline at Day 42||1.6|-0.9|0.5435
71658379|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.3551|TWO_SIDED|95.0|-0.7|1.8|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 8||1.8|-0.7|0.3551
71658380|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7495|TWO_SIDED|95.0|-1.1|1.6|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 15||1.6|-1.1|0.7495
71726876|NCT02136680|142967731|SUPERIORITY|Change in Palliative Outcomes from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|Regression Coefficient|0.165||||0.008|TWO_SIDED||||||Regression, Linear|||||||0.008
71726877|NCT05151445|142967738|OTHER||95% CI|-3.56||||0.002|TWO_SIDED|95.0|-5.65|-1.46|||McNemar|||Week 4 vs. Baseline||-1.46|-5.65|0.002
71726878|NCT05151445|142967738|OTHER||95% CI|-3.11||||0.004|TWO_SIDED|95.0|-5.07|-1.15|||McNemar|||Week 8 vs. Baseline||-1.15|-5.07|0.004
71726879|NCT05151445|142967738|OTHER||95% CI|-2.53||||0.038|TWO_SIDED|95.0|-4.9|0.16|||McNemar|||Week 12 vs. Baseline||0.16|-4.90|0.038
71726880|NCT05151445|142967739|OTHER||95% CI|9.61||||0.062|TWO_SIDED|95.0|-0.55|19.77|||McNemar|||Week 4 vs. Baseline||19.77|-0.55|0.062
71726881|NCT05151445|142967739|OTHER||95% CI|9.78||||0.098|TWO_SIDED|95.0|-2.01|21.56|||McNemar|||Week 8 vs. Baseline||21.56|-2.01|0.098
71726882|NCT05151445|142967739|OTHER||95% CI|17.06||||0.003|TWO_SIDED|95.0|6.51|27.6|||McNemar|||Week 12 vs. Baseline||27.60|6.51|0.003
71726883|NCT05151445|142967740|OTHER|||||||0.37|||||||McNemar|||Week 4 vs. Baseline||||0.37
71726884|NCT05151445|142967740|OTHER|||||||0.724|||||||McNemar|||Week 8 vs. Baseline||||0.724
71726885|NCT05151445|142967740|OTHER|||||||0.289|||||||McNemar|||Week 12 vs. Baseline||||0.289
71658381|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.6471|TWO_SIDED|95.0|-1.1|1.7|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 28||1.7|-1.1|0.6471
71726886|NCT05151445|142967741|OTHER|||||||1|||||||McNemar|||Week 4 vs. Baseline||||1.000
71726887|NCT05151445|142967741|OTHER|||||||1|||||||McNemar|||Week 8 vs. Baseline||||1.000
71726888|NCT05151445|142967741|OTHER|||||||1|||||||McNemar|||Weel 12 vs. Baseline||||1.000
71726889|NCT05151445|142967742|OTHER||95% CI|-1.1||||0.696|TWO_SIDED|95.0|-6.96|4.76|||McNemar|||Week 4 vs. Baseline||4.76|-6.96|0.696
71726890|NCT05151445|142967742|OTHER||95% CI|-1.08||||0.734|TWO_SIDED|95.0|-7.72|5.56|||McNemar|||Week 8 vs. Baseline||5.56|-7.72|0.734
71726891|NCT05151445|142967742|OTHER||95% CI|-4.15||||0.249|TWO_SIDED|95.0|-11.53|3.23|||McNemar|||Week 12 vs. Baseline||3.23|-11.53|0.249
71726892|NCT05151445|142967743|OTHER||95% CI|-0.04||||0.989|TWO_SIDED|95.0|-5.25|5.18|||McNemar|||Week 4 vs. Baseline||5.18|-5.25|0.989
71726893|NCT05151445|142967743|OTHER||95% CI|3.43||||0.263|TWO_SIDED|95.0|-2.83|9.69|||McNemar|||Week 8 vs. Baseline||9.69|-2.83|0.263
71726894|NCT05151445|142967743|OTHER||Slope|0.44||||0.882|TWO_SIDED|95.0|-5.8|6.68|||McNemar|||Week 12 vs. Baseline||6.68|-5.80|0.882
71726895|NCT05151445|142967744|OTHER||95% CI|-0.62||||0.425|TWO_SIDED|95.0|-2.23|0.98|||McNemar|||Week 4 vs. Baseline||0.98|-2.23|0.425
71726896|NCT05151445|142967744|OTHER||95% CI|-4.98||||0.205|TWO_SIDED|95.0|-9.08|-0.88|||McNemar|||Week 8 vs. Baseline||-0.88|-9.08|0.205
71726897|NCT05151445|142967744|OTHER||95% CI|-4.98||||0.02|TWO_SIDED|95.0|-9.08|-0.8|||McNemar|||Week 12 vs. Baseline||-0.8|-9.08|0.020
71726898|NCT05151445|142967745|OTHER||95% CI|0.429||||0.429|TWO_SIDED|95.0|-4.9|11.01|||McNemar|||Week 4 vs. Baseline||11.01|-4.90|0.429
71726899|NCT05151445|142967745|OTHER||95% CI|-4.39||||0.255|TWO_SIDED|95.0|-12.24|3.46|||McNemar|||Week 8 vs. Baseline||3.46|-12.24|0.255
71726900|NCT05151445|142967745|OTHER||95% CI|-7.0||||0.102|TWO_SIDED|95.0|-15.55|1.55|||McNemar|||Week 12 vs. Baseline||1.55|-15.55|0.102
71726901|NCT05151445|142967746|OTHER||95% CI|-1.94||||0.568|TWO_SIDED|95.0|-8.99|5.1|||McNemar|||Week 4 vs. Baseline||5.10|-8.99|0.568
71726902|NCT05151445|142967746|OTHER||95% CI|-4.11||||0.198|TWO_SIDED|95.0|-10.59|2.37|||McNemar|||Week 8 vs. Baseline||2.37|-10.59|0.198
71726903|NCT05151445|142967746|OTHER||95% CI|-3.76||||0.225|TWO_SIDED|95.0|-10.08|2.55|||McNemar|||Week 12 vs. Baseline||2.55|-10.08|.225
71726904|NCT01457014|142967809|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|p values have undergone Bonferroni adjustment for Central Apnea Index (CAI), Obstructive Apnea Index (OAI) and Hypopnea Index (HI)||||||<0.001
71726905|NCT01457014|142967810|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED|||||p value has undergone Bonferroni adjustment. P-Value applies to Av. 02 saturation|Wilcoxon (Mann-Whitney)|p value has undergone Bonferroni adjustment||||||0.627
71726906|NCT01457014|142967811|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.161
71726907|NCT01357161|142967812|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.08|TWO_SIDED|80.0|0.45|0.89|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.89|0.45|0.080
71726908|NCT01357161|142967814|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|80.0|0.39|0.79|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||0.79|0.39|0.030
71726909|NCT01357161|142967816|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-2.9|11.4||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||11.4|-2.9|
71726910|NCT01357161|142967817|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-1.3|||||TWO_SIDED|95.0|-16.2|13.6||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.||13.6|-16.2|
71726911|NCT01357161|142967818|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rat|5.2||||0.5247|TWO_SIDED|95.0|-10.9|21.1|||Miettinen and Nurminen's Method|||Stratified Miettinen and Nurminen's method with a two-sided p-Value for testing was used for comparison of the ORRs between the treatment groups in Part 2 portion of the study. A 95% confidence interval (CI) for the difference in response rates was provided.||21.1|-10.9|0.5247
71726912|NCT01357161|142967819|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.8|TWO_SIDED|95.0|0.4|3.34|||Cox proportional hazards model|||A stratified \[number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (\<12 months vs. ≥12 months)\] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.||3.34|0.40|0.800
71726913|NCT02825420|142967823|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
71726914|NCT02825420|142967824|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
71726915|NCT02825420|142967825|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
71726916|NCT02825420|142967827|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
71726917|NCT02825420|142967829|SUPERIORITY|||||||0.048|||||||Log Rank|||||||0.048
71726918|NCT02825420|142967830|SUPERIORITY|||||||0.51|||||||Log Rank|||||||0.51
71726919|NCT02226198|142967890|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
71726920|NCT02226198|142967891|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.3||||0.005|TWO_SIDED|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta||-9.1|-33.5|0.005
71726921|NCT02226198|142967892|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
71726922|NCT02226198|142967893|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.1||||0.003|TWO_SIDED|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-9.1|-29.7|0.003
71726923|NCT02226198|142967894|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
71726924|NCT02226198|142967895|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-22.9||||0.003|TWO_SIDED|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.3|-33.7|0.003
71726925|NCT02226198|142967896|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
71726926|NCT02226198|142967897|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-17.1||||0.024|TWO_SIDED|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-2.9|-29.2|0.024
71726927|NCT02226198|142967898|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
71726928|NCT02226198|142967899|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|7.4||||0.314|TWO_SIDED|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||24.5|-7.4|0.314
71726929|NCT02226198|142967900|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
71726930|NCT02226198|142967901|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-26.3||||0.08|TWO_SIDED|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||6.0|-48.7|0.080
71726931|NCT02226198|142967912|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
71726932|NCT02226198|142967913|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-30.4||||0.004|TWO_SIDED|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-13.3|-44.2|0.004
71726933|NCT02226198|142967914|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-27.6||||0.006|TWO_SIDED|95.0|-41.2|-11.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.0|-41.2|0.006
71726934|NCT02226198|142967915|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-25.6||||0.005|TWO_SIDED|95.0|-38.1|-10.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-10.5|-38.1|0.005
71726935|NCT02226198|142967916|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-28.2||||0.005|TWO_SIDED|95.0|-41.7|-11.4||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-11.4|-41.7|0.005
71726936|NCT02226198|142967917|SUPERIORITY_OR_OTHER||Relative difference in geometric LSM|-20.4||||0.013|TWO_SIDED|95.0|-32.8|-5.6||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.||-5.6|-32.8|0.013
71726937|NCT01288612|142967927|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Chi-squared|||||||0.25
71726938|NCT01288612|142967927|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
71726939|NCT01288612|142967927|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Chi-squared|||||||0.27
71726940|NCT01288612|142967927|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Chi-squared|||||||0.82
71726941|NCT01288612|142967928|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Kruskal-Wallis|||||||0.06
71726942|NCT01288612|142967929|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher Exact|||||||0.08
71726943|NCT01288612|142967930|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
71726944|NCT01288612|142967931|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71726945|NCT01288612|142967932|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71726946|NCT01288612|142967933|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for pain scale||||<0.001
71726947|NCT01288612|142967933|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for choking scale||||<0.001
71726948|NCT01288612|142967933|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for gagging scale||||<0.001
71726949|NCT01288612|142967933|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the arms for anxiety scale||||<0.001
71726950|NCT01288612|142967933|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||Comparison between arms for overall tolerance scale||||<0.001
71726951|NCT01288612|142967934|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||||||0.001
71726952|NCT01730339|142967942|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.0219|TWO_SIDED|90.0|0.19|1.16|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.16|0.19|0.0219
71726953|NCT01730339|142967942|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.4038|TWO_SIDED|90.0|-0.24|0.72|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.72|-0.24|0.4038
71726954|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.43|0.2||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.20|-0.43|
71726955|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.43|0.11||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.11|-0.43|
71726956|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.15|0.52||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.15|
71726957|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.22|0.36||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.36|-0.22|
71726958|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.07|0.77||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.77|0.07|
71726959|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.05|0.65||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.65|0.05|
71771006|NCT01857310|143041566|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-20.9|21.4|||||Weighted for loss to follow-up and adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Total motile sperm count will be compared using two sided tests conducted at the 0.05 level."||21.4|-20.9|
71726960|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.03|0.68||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|-0.03|
71771007|NCT01857310|143041567|SUPERIORITY||Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-4.7|3.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.0|-4.7|
71771008|NCT01857310|143041567|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.91|1.09|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. hCG detected pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.09|0.91|
71726961|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.52||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.09|
71771009|NCT01857310|143041568|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-4.9|2.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||2.8|-4.9|
71831010|NCT02528188|143167414|SUPERIORITY||Risk difference|0.1||||0.7245|TWO_SIDED|95.0|-0.74|1.51|||Exact methods for risk difference|||Primary osteonecrosis||1.51|-0.74|0.7245
71726962|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.18|0.42||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.18|
71726963|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.35|0.22||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.22|-0.35|
71831011|NCT02528188|143167414|SUPERIORITY||Risk difference|0.1||||0.7182|TWO_SIDED|95.0|-0.74|1.52|||Exact methods for risk difference|||Primary osteonecrosis||1.52|-0.74|0.7182
71658382|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1832|TWO_SIDED|95.0|-0.5|2.5|||MMRM|||Bodily Pain Domain Score: Change from Baseline at Day 42||2.5|-0.5|0.1832
71771010|NCT01857310|143041568|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.89|1.08|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Clinical intrauterine pregnancy will be compared using two sided tests conducted at the 0.05 level."||1.08|0.89|
71658383|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.5||0.0168|TWO_SIDED|95.0|0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 8||2.2|0.2|0.0168
71658384|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0787|TWO_SIDED|95.0|-0.1|2.0|||MMRM|||General Health Domain Score: Change from Baseline at Day 15||2.0|-0.1|0.0787
71658385|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.59||0.4273|TWO_SIDED|95.0|-0.7|1.6|||MMRM|||General Health Domain Score: Change from Baseline at Day 28||1.6|-0.7|0.4273
71658386|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.0938|TWO_SIDED|95.0|-0.2|2.2|||MMRM|||General Health Domain Score: Change from Baseline at Day 42||2.2|-0.2|0.0938
71658387|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.88||0.0033|TWO_SIDED|95.0|0.9|4.3|||MMRM|||Vitality Domain Score: Change from Baseline at Day 8||4.3|0.9|0.0033
71658388|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.0029|TWO_SIDED|95.0|1.1|5.1|||MMRM|||Vitality Domain Score: Change from Baseline at Day 15||5.1|1.1|0.0029
71658389|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.04||0.0791|TWO_SIDED|95.0|-0.2|3.9|||MMRM|||Vitality Domain Score: Change from Baseline at Day 28||3.9|-0.2|0.0791
71658390|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.12||0.0761|TWO_SIDED|95.0|-0.2|4.2|||MMRM|||Vitality Domain Score: Change from Baseline at Day 42||4.2|-0.2|0.0761
71658391|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.91||0.1568|TWO_SIDED|95.0|-0.5|3.1|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 8||3.1|-0.5|0.1568
71658392|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2807|TWO_SIDED|95.0|-0.9|3.0|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 15||3.0|-0.9|0.2807
71831012|NCT02528188|143167414|SUPERIORITY||Risk difference|0.2||||0.6824|TWO_SIDED|95.0|-0.96|1.9|||Exact methods for risk difference|||Subchondral insufficiency fracture||1.90|-0.96|0.6824
71658393|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7751|TWO_SIDED|95.0|-1.8|2.4|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 28||2.4|-1.8|0.7751
71658394|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.07||0.0913|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Social Functioning Domain Score: Change from Baseline at Day 42||3.9|-0.3|0.0913
71658395|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.05||0.2863|TWO_SIDED|95.0|-0.9|3.2|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 8||3.2|-0.9|0.2863
71658396|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.13||0.1801|TWO_SIDED|95.0|-0.7|3.7|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 15||3.7|-0.7|0.1801
71658397|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.16||0.1107|TWO_SIDED|95.0|-0.4|4.1|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 28||4.1|-0.4|0.1107
71658398|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.23||0.3274|TWO_SIDED|95.0|-1.2|3.6|||MMRM|||Role-Emotional Domain Score: Change from Baseline at Day 42||3.6|-1.2|0.3274
71658399|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.93||0.0873|TWO_SIDED|95.0|-0.2|3.4|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 8||3.4|-0.2|0.0873
71658400|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|1.05||0.0871|TWO_SIDED|95.0|-0.3|3.9|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 15||3.9|-0.3|0.0871
71658401|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.12||0.3095|TWO_SIDED|95.0|-1.1|3.3|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 28||3.3|-1.1|0.3095
71658402|NCT04442490|142831830|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.1477|TWO_SIDED|95.0|-0.6|4.0|||MMRM|||Mental Health Domain Score: Change from Baseline at Day 42||4.0|-0.6|0.1477
71658403|NCT04442490|142831831|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57||0.0828|TWO_SIDED|95.0|-2.1|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 8||0.1|-2.1|0.0828
71658404|NCT04442490|142831831|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62||0.0606|TWO_SIDED|95.0|-2.4|0.1|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 15||0.1|-2.4|0.0606
71658405|NCT04442490|142831831|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63||0.1079|TWO_SIDED|95.0|-2.3|0.2|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 28||0.2|-2.3|0.1079
71658406|NCT04442490|142831831|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.3951|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Model used was the MMRM with treatment (SAGE-217/placebo), baseline PHQ-9 total score, antidepressant use at baseline (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects with Unstructured covariance structure.|Change from Baseline at Day 42||0.7|-1.9|0.3951
71658407|NCT02227147|142831832|SUPERIORITY||Difference in percentage|40.4|||=|0.006|TWO_SIDED|90.0|14.2|66.6|||Chi-squared|||||66.6|14.2|=0.006
71658408|NCT02227147|142831833|SUPERIORITY||Difference in percentage|36.1|||=|0.013|TWO_SIDED|95.0|9.4|62.7|||Chi-squared|||||62.7|9.4|=0.013
71831013|NCT02528188|143167414|SUPERIORITY||Risk difference|0.3||||0.5632|TWO_SIDED|95.0|-0.86|2.03|||Exact methods for risk difference|||Subchondral insufficiency fracture||2.03|-0.86|0.5632
71726964|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.47|0.24||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.47|
71726965|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.6|0.06||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.06|-0.60|
71726966|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.35|0.41||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.41|-0.35|
71831014|NCT02528188|143167415|SUPERIORITY||Rate Difference|19.56||||0.0027|TWO_SIDED|95.0|6.78|32.35|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||32.35|6.78|0.0027
71726967|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.33|0.37||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.37|-0.33|
71726968|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.24|0.53||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.53|-0.24|
71726969|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.39|0.32||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.39|
71726970|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.22|0.58||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.58|-0.22|
71726971|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.42|0.35||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.42|
71726972|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.05|0.84||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.84|-0.05|
71726973|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.62|0.23||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.62|
71831015|NCT02528188|143167415|SUPERIORITY||Rate Difference|51.48|||<|0.0001|TWO_SIDED|95.0|34.47|68.5|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2||68.50|34.47|<0.0001
71831016|NCT02528188|143167415|SUPERIORITY||Rate Difference|17.58||||0.0047|TWO_SIDED|95.0|5.39|29.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||29.76|5.39|0.0047
71726974|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.4|1.49||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.49|0.40|
71726975|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.3|0.72||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|-0.30|
71726976|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.68|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.13|1.24||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.24|0.13|
71831017|NCT02528188|143167415|SUPERIORITY||Rate Difference|38.22|||<|0.0001|TWO_SIDED|95.0|23.05|53.4|||Poisson model for rate difference|||Rapidly Progressive OA Type 1||53.40|23.05|<0.0001
71831018|NCT02528188|143167415|SUPERIORITY||Rate Difference|1.94||||0.3214|TWO_SIDED|95.0|-1.89|5.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||5.76|-1.89|0.3214
71831019|NCT02528188|143167415|SUPERIORITY||Rate Difference|12.88||||0.0008|TWO_SIDED|95.0|5.36|20.39|||Poisson model for rate difference|||Rapidly Progressive OA Type 2||20.39|5.36|0.0008
71831020|NCT02528188|143167415|SUPERIORITY||Rate Difference|1.9||||0.5394|TWO_SIDED|95.0|-4.17|7.96|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||7.96|-4.17|0.5394
71726977|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.38|0.67||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.38|
71726978|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.01|0.78||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.78|-0.01|
71831021|NCT02528188|143167415|SUPERIORITY||Rate Difference|2.98||||0.3636|TWO_SIDED|95.0|-3.44|9.39|||Poisson model for rate difference|||Subchondral Insufficiency Fracture||9.39|-3.44|0.3636
71658409|NCT02227147|142831834|SUPERIORITY||difference in percentage|19.0|||=|0.191|TWO_SIDED|95.0|-9.0|47.1|||Chi-squared|||week 4 - central reviewer||47.1|-9.0|=0.191
71726979|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.5|0.28||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.28|-0.50|
71726980|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.23|0.67||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.23|
71726981|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.63|0.24||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.63|
71726982|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.74|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.21|1.26||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.26|0.21|
71831022|NCT02528188|143167415|SUPERIORITY||Poisson model for rate difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
71831023|NCT02528188|143167415|SUPERIORITY||Rate Difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis||||
71726983|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.41|0.59||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.59|-0.41|
71726984|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.02||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.02|0.02|
71726985|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.33|0.63||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.33|
71831024|NCT02528188|143167416|SUPERIORITY||Risk Difference (RD)|4.87||||0.0002|TWO_SIDED|95.0|2.43|7.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Exact methods for risk difference|||||7.74|2.43|0.0002
71831025|NCT02528188|143167416|SUPERIORITY||Risk Difference (RD)|9.41|||<|0.0001|TWO_SIDED|95.0|6.73|12.52|||Exact methods for risk difference|||||12.52|6.73|<0.0001
71726986|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.09|0.67||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.67|-0.09|
71726987|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.39|0.34||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.34|-0.39|
71726988|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.12|0.74||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.74|-0.12|
71726989|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.76|0.05||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.05|-0.76|
71726990|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.25|1.2||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.25|
71726991|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.46|0.42||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.46|
71726992|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|0.01|1.05||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.05|0.01|
71831026|NCT02528188|143167417|SUPERIORITY||Rate Difference|48.25|||<|0.0001|TWO_SIDED|95.0|26.76|69.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Poisson model for rate difference|||||69.74|26.76|<0.0001
71726993|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.0|0.98||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.98|0.00|
71726994|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-0.29|0.62||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.62|-0.29|
71726995|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|-0.28|0.43||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.43|-0.28|
71831027|NCT02528188|143167417|SUPERIORITY||Rate Difference|95.83|||<|0.0001|TWO_SIDED|95.0|70.25|121.42|||Poisson model for rate difference|||||121.42|70.25|<0.0001
71658410|NCT02227147|142831834|SUPERIORITY||difference in percentage|10.7|||=|0.464|TWO_SIDED|95.0|-17.7|39.1|||Chi-squared|||week 6 - central reviewer||39.1|-17.7|=0.464
71726996|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.02|1.0||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.00|0.02|
71726997|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.53|0.23||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.53|
71726998|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.08|1.2||||||Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.20|0.08|
71726999|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.44|0.42||||||Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.42|-0.44|
71727000|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.69|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|0.09|1.28||||||Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.28|0.09|
71727001|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.23|0.69||||||Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.69|-0.23|
71831028|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0979|TWO_SIDED|95.0|-0.15|0.01|||ANCOVA|||Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.15|0.0979
71831029|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||ANCOVA|||Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.08|-0.24|<0.0001
71831030|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1162|TWO_SIDED|95.0|-0.17|0.02|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.02|-0.17|0.1162
71771011|NCT01857310|143041569|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.5|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||0.6|-0.5|
71727002|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2778|TWO_SIDED|90.0|-0.12|0.6|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.60|-0.12|0.2778
71727003|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.22||0.6888|TWO_SIDED|90.0|-0.28|0.45|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.45|-0.28|0.6888
71771012|NCT01857310|143041569|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.37|3.97|||||Adjusted for fertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Ectopic pregnancy will be compared using two sided tests conducted at the 0.05 level."||3.97|0.37|
71771013|NCT01857310|143041570|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-3.7|1.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.5|-3.7|
71727004|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3515|TWO_SIDED|90.0|-0.18|0.65|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.65|-0.18|0.3515
71727005|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3788|TWO_SIDED|90.0|-0.64|0.19|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.19|-0.64|0.3788
71727006|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.28||0.0044|TWO_SIDED|90.0|0.35|1.29|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||1.29|0.35|0.0044
71727007|NCT01730339|142967943|SUPERIORITY_OR_OTHER||Least Square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6848|TWO_SIDED|90.0|-0.35|0.58|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.||0.58|-0.35|0.6848
71727008|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7552|TWO_SIDED|90.0|-0.44|0.64|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.64|-0.44|0.7552
71727009|NCT01730339|142967944|SUPERIORITY_OR_OTHER||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6605|TWO_SIDED|90.0|-0.3|0.52|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.52|-0.30|0.6605
71727010|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.9842|TWO_SIDED|90.0|-0.55|0.56|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.56|-0.55|0.9842
71831031|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0128|TWO_SIDED|95.0|-0.22|-0.03|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.22|0.0128
71831032|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.8885|TWO_SIDED|95.0|-0.17|0.2|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.20|-0.17|0.8885
71831033|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6345|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.15|-0.24|0.6345
71658411|NCT02227147|142831834|SUPERIORITY||difference in percentage|14.9|||=|0.308|TWO_SIDED|95.0|-13.4|43.1|||Chi-squared|||week 4 - investigator||43.1|-13.4|=0.308
71771014|NCT01857310|143041570|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Early pregnancy loss will be compared using two sided tests conducted at the 0.05 level."||1.15|0.75|
71771015|NCT01857310|143041571|SUPERIORITY||Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.3|-1.9|
71831034|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4406|TWO_SIDED|95.0|-0.32|0.14|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.14|-0.32|0.4406
71831035|NCT02528188|143167418|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.7109|TWO_SIDED|95.0|-0.19|0.28|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.28|-0.19|0.7109
71831036|NCT02528188|143167419|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.102|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.03|-0.30|0.1020
71831037|NCT02528188|143167419|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.08||0.023|TWO_SIDED|95.0|-0.35|-0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||-0.03|-0.35|0.0230
71831038|NCT02528188|143167419|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0645|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.01|-0.37|0.0645
71831039|NCT02528188|143167419|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5005|TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.||0.13|-0.26|0.5005
71658412|NCT02227147|142831834|SUPERIORITY||difference in percentage|23.6|||=|0.106|TWO_SIDED|95.0|-4.2|51.3|||Chi-squared|||week 6 - investigator||51.3|-4.2|=0.106
71658413|NCT02227147|142831835|SUPERIORITY||difference in percentage|9.5|||=|0.255|TWO_SIDED|95.0|-6.9|25.9|||Chi-squared|||week 4||25.9|-6.9|=0.255
71658414|NCT02227147|142831835|SUPERIORITY||difference in percentage|0.8|||=|0.927|TWO_SIDED|95.0|-15.6|17.1|||Chi-squared|||week 6||17.1|-15.6|=0.927
71658415|NCT02227147|142831835|SUPERIORITY||difference in percentage|18.6|||=|0.062|TWO_SIDED|95.0|-0.7|37.8|||Chi-squared|||week 8||37.8|-0.7|=0.062
71658416|NCT02227147|142831836|SUPERIORITY||difference in least square means|1.1|||=|0.745|TWO_SIDED|95.0|-5.6|7.7|||ANCOVA|||||7.7|-5.6|=0.745
71658417|NCT02227147|142831837|SUPERIORITY||difference in percentage|-3.8|||=|0.672|TWO_SIDED|95.0|-21.3|13.7|||Chi-squared|||week 4||13.7|-21.3|=0.672
71658418|NCT02227147|142831837|SUPERIORITY||difference in percentage|0.5|||=|0.955|TWO_SIDED|95.0|-18.5|19.6|||Chi-squared|||week 6||19.6|-18.5|=0.955
71658419|NCT02227147|142831837|SUPERIORITY||difference in percentage|-3.6|||=|0.727|TWO_SIDED|95.0|-23.9|16.7|||Chi-squared|||week 8||16.7|-23.9|=0.727
71658420|NCT02227147|142831838|SUPERIORITY||least square mean difference|0.6|||=|0.207|TWO_SIDED|95.0|-0.4|1.5|||ANCOVA|||||1.5|-0.4|=0.207
71658421|NCT02227147|142831839|SUPERIORITY||difference in percentage|-13.3|||=|0.11|TWO_SIDED|95.0|-30.5|3.9|||Chi-squared|||||3.9|-30.5|=0.110
71658422|NCT03514641|142831840|SUPERIORITY||LS Means difference|-2.72||||0.0025|TWO_SIDED|95.0|-4.47|-0.96|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.96|-4.47|0.0025
71658423|NCT03514641|142831841|SUPERIORITY||Mean Difference (Final Values)|-2.43||||0.0117|TWO_SIDED|95.0|-4.32|-0.54|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.54|-4.32|0.0117
71658424|NCT03514641|142831842|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1317|TWO_SIDED|95.0|0.92|1.83||Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP|Covariance|||||1.83|0.92|0.1317
71658425|NCT03514641|142831843|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0113|TWO_SIDED|95.0|1.11|2.3|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.30|1.11|0.0113
71658426|NCT03514641|142831844|SUPERIORITY||Mean Difference (Final Values)|-4.63|||<|0.0001|TWO_SIDED|95.0|-6.83|-2.42|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-2.42|-6.83|<0.0001
71658427|NCT03514641|142831845|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0004|TWO_SIDED|95.0|1.32|2.62|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.62|1.32|0.0004
71658428|NCT03514641|142831846|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.0863|TWO_SIDED|95.0|-1.79|0.12|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.12|-1.79|0.0863
71658429|NCT03514641|142831847|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0232|TWO_SIDED|95.0|1.06|2.08|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.08|1.06|0.0232
71658430|NCT03514641|142831848|SUPERIORITY||Odds Ratio (OR)|1.81||||0.014|TWO_SIDED|95.0|1.13|2.91|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.91|1.13|0.0140
71658431|NCT03514641|142831849|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.0011|TWO_SIDED|95.0|-3.7|-0.92|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.92|-3.70|0.0011
71831040|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0358|TWO_SIDED|95.0|1.04|3.29|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||3.29|1.04|0.0358
71771016|NCT01857310|143041571|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.63|1.36|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preeclampsia/gestational hypertension will be compared using two sided tests conducted at the 0.05 level."||1.36|0.63|
71658432|NCT03514641|142831850|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0094|TWO_SIDED|95.0|1.13|2.35|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||2.35|1.13|0.0094
71771017|NCT01857310|143041572|SUPERIORITY||Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||0.6|-1.9|
71771018|NCT01857310|143041572|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.47|1.27|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational diabetes will be compared using two sided tests conducted at the 0.05 level."||1.27|0.47|
71771019|NCT01857310|143041573|SUPERIORITY||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-1.4|3.8|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||3.8|-1.4|
71771020|NCT01857310|143041573|SUPERIORITY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.89|1.39|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Cesarean delivery will be compared using two sided tests conducted at the 0.05 level."||1.39|0.89|
71771021|NCT01857310|143041574|SUPERIORITY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|0.2|3.6|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||3.6|0.2|
71771022|NCT01857310|143041574|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|1.04|2.16|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Preterm delivery will be compared using two sided tests conducted at the 0.05 level."||2.16|1.04|
71771023|NCT01857310|143041575|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-1.5|2.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||2.0|-1.5|
71771024|NCT01857310|143041575|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.75|1.49|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Small for gestational age will be compared using two sided tests conducted at the 0.05 level."||1.49|0.75|
71771025|NCT01857310|143041576|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Gestational age will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.5|
71771026|NCT01857310|143041577|SUPERIORITY||Risk Difference (RD)|-64.7|||||TWO_SIDED|95.0|-156.0|26.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Birth weight will be compared using two sided tests conducted at the 0.05 level."||26.4|-156|
71771027|NCT01857310|143041578|SUPERIORITY||Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||0.1|-0.6|
71771028|NCT01857310|143041578|SUPERIORITY||Risk Ratio (RR)|0.25|||||TWO_SIDED|95.0|0.03|2.24|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Stillbirth will be compared using two sided tests conducted at the 0.05 level."||2.24|0.03|
71771029|NCT01857310|143041579|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||0.5|-0.3|
71727011|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.25||0.401|TWO_SIDED|90.0|-0.21|0.63|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.63|-0.21|0.4010
71727012|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.38||0.2491|TWO_SIDED|90.0|-0.19|1.07|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.07|-0.19|0.2491
71727013|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.998|TWO_SIDED|90.0|-0.47|0.47|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.47|-0.47|0.9980
71727014|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.39||0.473|TWO_SIDED|90.0|-0.37|0.93|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.93|-0.37|0.4730
71727015|NCT01730339|142967944|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.3||0.5413|TWO_SIDED|90.0|-0.67|0.31|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.31|-0.67|0.5413
71727016|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|1.32|STANDARD_ERROR_OF_MEAN|2.76|||TWO_SIDED|90.0|-3.28|5.92||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.92|-3.28|
71727017|NCT01730339|142967945|SUPERIORITY_OR_OTHER||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|90.0|-3.63|2.91||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.91|-3.63|
71727018|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|3.82|STANDARD_ERROR_OF_MEAN|3.85|||TWO_SIDED|90.0|-2.6|10.24||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||10.24|-2.60|
71727019|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|0.16|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|90.0|-4.37|4.68||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||4.68|-4.37|
71727020|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|90.0|-4.34|2.95||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||2.95|-4.34|
71727021|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-4.53|1.45||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.45|-4.53|
71771030|NCT01857310|143041579|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.25|8.95|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Neonatal mortality will be compared using two sided tests conducted at the 0.05 level."||8.95|0.25|
71727022|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|1.75|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|90.0|-2.07|5.58||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||5.58|-2.07|
71727023|NCT01730339|142967945|SUPERIORITY_OR_OTHER||Least Square mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.87|||TWO_SIDED|90.0|-4.24|1.99||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||1.99|-4.24|
71727024|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.15|0.35||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.35|-0.15|
71727025|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|-0.22|0.29||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.29|-0.22|
71727026|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.54|0.04|
71658433|NCT03514641|142831851|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.0083|TWO_SIDED|95.0|-5.57|-0.83|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||-0.83|-5.57|0.0083
71727027|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.36|0.15||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.15|-0.36|
71727028|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.32|0.82||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.82|0.32|
71727029|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.21|0.3||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.21|
71727030|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.18|0.68||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.68|0.18|
71727031|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_DEVIATION|0.15|||TWO_SIDED|90.0|-0.18|0.32||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.32|-0.18|
71727032|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.39|-0.20|
71727033|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.28|0.23||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.23|-0.28|
71727034|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.29|0.3||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.30|-0.29|
71727035|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.18|0.33||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.33|-0.18|
71727036|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.12|0.72||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.72|0.12|
71727037|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.27|0.24||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.24|-0.27|
71727038|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.5||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.50|-0.09|
71727039|NCT01730339|142967946|SUPERIORITY_OR_OTHER||Least Square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.11|0.4||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||0.40|-0.11|
71727040|NCT00395291|142967991|SUPERIORITY_OR_OTHER||||||<|0.001||||||The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.|ANCOVA|||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions.~Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis."||||<0.001
71727041|NCT00395291|142967992|SUPERIORITY_OR_OTHER|||||||0.169|||||||ANCOVA|The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.169
71727042|NCT00395291|142967993|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions.~Because Leptin is considered a secondary outcome, no power analysis was conducted."||||0.063
71727043|NCT00395291|142967994|SUPERIORITY_OR_OTHER|||||||0.075|||||||ANCOVA|The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions.~Because serum-insulin is considered a secondary outcome, no power analysis was conducted."||||0.075
71727044|NCT00395291|142967995|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANCOVA|||||||.782
71727045|NCT00395291|142967996|SUPERIORITY_OR_OTHER|||||||0.385|||||||ANCOVA|The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.385
71727046|NCT00395291|142967997|SUPERIORITY_OR_OTHER|||||||0.929|||||||ANCOVA|The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions.~Because CRPs is considered as a secondary outcome, no power analysis was conducted."||||0.929
71727047|NCT00395291|142967998|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions.~Because IL-1 is considered as a secondary outcome, no power analysis was conducted"||||0.905
71727048|NCT00395291|142967999|SUPERIORITY_OR_OTHER|||||||0.233||95.0|||||ANCOVA|||||||0.233
71727049|NCT00395291|142968000|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANCOVA|The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions.~Because IL-10 is considered as a secondary outcome, no power analysis was conducted."||||0.277
71727050|NCT00395291|142968001|SUPERIORITY_OR_OTHER|||||||0.875|||||||ANCOVA|The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.875
71727051|NCT00395291|142968002|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANCOVA|The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.545
71727052|NCT00395291|142968003|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANCOVA|Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."||||0.900
71727053|NCT01328041|142968006|SUPERIORITY_OR_OTHER||T distribution|-1.432|||<|0.001|TWO_SIDED|95.0|-1.52|-1.343||The P value was derived by the null hypothesis testing of no change from Baseline in HIV-1 RNA at Day 8 at the two-sided 5% significance level using a single sample t-test.|t-test, 2 sided|||||-1.343|-1.520|<0.001
71727054|NCT01328041|142968007|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|62.0|76.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 24.|||76|62|
71727055|NCT01328041|142968008|SUPERIORITY_OR_OTHER||percentage of participants|63.0|||||TWO_SIDED|95.0|56.0|70.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 48.|||70|56|
71727056|NCT02688088|142968028|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.965|1.06||||||||1.06|0.965|
71727057|NCT02688088|142968029|SUPERIORITY||Ratio of Geometric LS Means|0.935|||||TWO_SIDED|90.0|0.871|1.0||||||||1.00|0.871|
71727058|NCT02688088|142968030|SUPERIORITY||Ratio of Geometric LS Means|1.05|||||TWO_SIDED|90.0|0.898|1.22||||||||1.22|0.898|
71831041|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0021|TWO_SIDED|95.0|1.37|4.12|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||4.12|1.37|0.0021
71831042|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0301|TWO_SIDED|95.0|1.07|3.77|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||3.77|1.07|0.0301
71831043|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|2.65||||0.0016|TWO_SIDED|95.0|1.45|4.85|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.85|1.45|0.0016
71831044|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3002|TWO_SIDED|95.0|0.18|1.7|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||1.70|0.18|0.3002
71831045|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8997|TWO_SIDED|95.0|0.39|2.89|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.||2.89|0.39|0.8997
71831046|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4559|TWO_SIDED|95.0|0.53|4.18|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||4.18|0.53|0.4559
71831047|NCT02528188|143167420|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5996|TWO_SIDED|95.0|0.2|2.54|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.||2.54|0.20|0.5996
71888557|NCT01097629|143298079|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-21.7|||<|1e-05|TWO_SIDED|95.0|-28.6|-14.9|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-14.9|-28.6|<0.00001
71727059|NCT02688088|142968031|SUPERIORITY||Ratio of Geometric LS Means|0.845|||||TWO_SIDED|90.0|0.76|0.94||||||||0.940|0.760|
71727060|NCT02688088|142968032|SUPERIORITY||Ratio of Geometric LS Means|1.56|||||TWO_SIDED|90.0|1.35|1.81||||||||1.81|1.35|
71727061|NCT02688088|142968033|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.956|1.13||||||||1.13|0.956|
71831048|NCT02528188|143167421|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0714|TWO_SIDED|95.0|0.9|12.65|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.65|0.90|0.0714
71831049|NCT02528188|143167421|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0681|TWO_SIDED|95.0|0.91|12.84|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate||12.84|0.91|0.0681
71831050|NCT02528188|143167421|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0967|TWO_SIDED|95.0|0.81|11.95|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.95|0.81|0.0967
71831051|NCT02528188|143167421|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0976|TWO_SIDED|95.0|0.81|11.9|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate||11.90|0.81|0.0976
71831052|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2212|TWO_SIDED|95.0|-0.27|0.06|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.27|0.2212
71831053|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.4557|TWO_SIDED|95.0|-0.1|0.23|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.10|0.4557
71888558|NCT00132041|143298082|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
71727062|NCT02688088|142968034|SUPERIORITY||Mean Difference (Final Values)|0.976|||||TWO_SIDED|90.0|0.805|1.18||||||||1.18|0.805|
71727063|NCT02688088|142968035|SUPERIORITY||Ratio of Geometric LS Means|0.867|||||TWO_SIDED|90.0|0.775|0.972||||||||0.972|0.775|
71727064|NCT02449889|142968049|NON_INFERIORITY|Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) \> -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.8|-0.6|
71727065|NCT02449889|142968049|NON_INFERIORITY|As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.5|2.0|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||2.0|-0.5|
71888559|NCT00132041|143298082|OTHER||Success rate|0.19|||||TWO_SIDED|95.0|0.136|0.252||||||logistic regression model after specifying site as cluster (using GEE approach).||0.252|0.136|
71727066|NCT02449889|142968050|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.6|1.5|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC||1.5|-0.6|
71727067|NCT02449889|142968050|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC||1.6|-0.4|
71727068|NCT02449889|142968051|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.6|1.3|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC||1.3|-0.6|
71658434|NCT03514641|142831852|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.1085|TWO_SIDED|95.0|-1.87|0.19|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.19|-1.87|0.1085
71658435|NCT03514641|142831853|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0837|TWO_SIDED|95.0|-2.67|0.17|||Covariance|Covariance model diabetes status, eGFR at screening, pre-treatment status, treatment, and baseline 24-hour mean SBP||||0.17|-2.67|0.0837
71727069|NCT02449889|142968051|NON_INFERIORITY|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||ANOVA with treatment, stratum (\<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.||1.4|-0.5|
71727070|NCT00385944|142968121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.91|||<|0.001|TWO_SIDED|95.0|-17.02|-8.81|||Mixed Models Analysis|||||-8.81|-17.02|<0.001
71727071|NCT00385944|142968122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.81|||<|0.001|TWO_SIDED|95.0|-10.96|-4.65|||Mixed Models Analysis|||||-4.65|-10.96|<0.001
71727072|NCT00385944|142968123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.98|||<|0.001|TWO_SIDED|95.0|-17.06|-6.9|||Mixed Models Analysis|||||-6.90|-17.06|<0.001
71727073|NCT00385944|142968124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.3||||0.001|TWO_SIDED|95.0|-6.84|-1.76|||Mixed Models Analysis|||||-1.76|-6.84|0.001
71727074|NCT00385944|142968125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.16|||<|0.001|TWO_SIDED|95.0|7.05|23.26|||Mixed Models Analysis|||||23.26|7.05|<0.001
71727075|NCT00385944|142968126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.69||||0.001|TWO_SIDED|95.0|5.56|19.81|||Mixed Models Analysis|||||19.81|5.56|0.001
71727076|NCT00385944|142968127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.26||||0.015|TWO_SIDED|95.0|2.17|18.34|||Mixed Models Analysis|||||18.34|2.17|0.015
71727077|NCT00385944|142968128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.85||||0.123|TWO_SIDED|95.0|-1.13|8.84|||Mixed Models Analysis|||||8.84|-1.13|0.123
71727078|NCT00385944|142968129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.83|||<|0.001|TWO_SIDED|95.0|-23.05|-10.62|||Mixed Models Analysis|||||-10.62|-23.05|<0.001
71727079|NCT00385944|142968130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.44|||<|0.001|TWO_SIDED|95.0|-70.87|-38.01|||Mixed Models Analysis|||||-38.01|-70.87|<0.001
71727080|NCT00385944|142968132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.5|||<|0.001||95.0|||||two-sided paired t-test|||||||<.001
71727081|NCT00385944|142968133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.011||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.011
71727082|NCT00385944|142968133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.847||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately||||0.847
71727083|NCT00385944|142968134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.24||||0.008|TWO_SIDED|95.0|-15.99|-2.49|||t-test, 2 sided|||||-2.49|-15.99|0.008
71727084|NCT00385944|142968135|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.52|||<|0.001|TWO_SIDED|95.0|9.22|25.83|||t-test, 2 sided|||||25.83|9.22|<0.001
71727085|NCT00834990|142968162|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.41||||||90.0|97.13|110.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110.08|97.13|
71727086|NCT00834990|142968163|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|101.68||||||90.0|96.79|106.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||106.83|96.79|
71727087|NCT00834990|142968164|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.17||||||90.0|98.5|108.05|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.05|98.5|
71727088|NCT00791479|142968171|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71727089|NCT00791479|142968171|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71727090|NCT00791479|142968171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.069||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.069
71727091|NCT00791479|142968171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727092|NCT00791479|142968171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727093|NCT00791479|142968171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727094|NCT00791479|142968172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71727095|NCT00791479|142968172|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.023
71727096|NCT00791479|142968172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71727097|NCT00791479|142968172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was P\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71727098|NCT00791479|142968173|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71727099|NCT00791479|142968173|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71727100|NCT00791479|142968173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.81||||0.456||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.456
71727101|NCT00791479|142968173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.53|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727102|NCT00791479|142968173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.96|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727103|NCT00791479|142968173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.71|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727104|NCT00791479|142968174|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels \<7.0%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
71727105|NCT00791479|142968174|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.||||||<0.001
71727106|NCT00791479|142968175|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71727107|NCT00791479|142968175|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||<0.001
71727108|NCT00791479|142968175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.65||||0.378||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.378
71727109|NCT00791479|142968175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.09|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727110|NCT00791479|142968175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.34|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727111|NCT00791479|142968175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.67|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||<0.001
71727112|NCT00791479|142968176|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||<0.001
71727113|NCT00791479|142968176|SUPERIORITY_OR_OTHER|||||||0.036||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.036
71727114|NCT00791479|142968177|SUPERIORITY_OR_OTHER|||||||0.45||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.450
71727115|NCT00791479|142968177|SUPERIORITY_OR_OTHER|||||||0.329||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.329
71727116|NCT00791479|142968185|SUPERIORITY_OR_OTHER|||||||0.969||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.||||0.969
71727117|NCT00791479|142968185|SUPERIORITY_OR_OTHER|||||||0.009||||||A priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.||||0.009
71727118|NCT00791479|142968185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.14||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.140
71727119|NCT00791479|142968185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.247||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.247
71727120|NCT00791479|142968185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.975||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||0.975
71727121|NCT00791479|142968185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis|||||||1.00
71771031|NCT01857310|143041580|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||0.4|-0.2|
71727122|NCT01778049|142968188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.0013||95.0|-0.52|-0.13|||Mixed Model Repeated Measure (MMRM)|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.|Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.13|-0.52|0.0013
71727123|NCT01778049|142968188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.66|-0.28|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates \& baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.28|-0.66|<0.0001
71727124|NCT01778049|142968189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.25||0.0103||95.0|-1.15|-0.16|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).|Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.16|-1.15|0.0103
71727125|NCT01778049|142968189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.22||0.0452||95.0|-0.87|-0.01|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c \& baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.||-0.01|-0.87|0.0452
71727126|NCT02379988|142968201|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.0063||||||P-value for Free breathing and Breath Holding Heart Mean|Wilcoxon (Mann-Whitney)|||||||=0.0063
71727127|NCT02379988|142968201|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Free breathing and Breath Holding Lung Mean|Wilcoxon (Mann-Whitney)|||||||=0 .0110
71727128|NCT02379988|142968201|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.5098||||||P-value for Free breathing and Breath Holding LAD Mean|Wilcoxon (Mann-Whitney)|||||||=0.5098
71727129|NCT02379988|142968202|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions|||||=|0.001||||||P-value for Heart Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0010
71727130|NCT02379988|142968202|EQUIVALENCE|The wilcoxon paired signed rank test was used as the primary analysis because of the non-normal distributions.|||||=|0.011||||||P-value for Lung Max Free breathing and Breath Hold|Wilcoxon (Mann-Whitney)|||||||=0.0110
71727131|NCT02379988|142968203|EQUIVALENCE|Paired T-test|||||=|0.01||||||P-value for Large breast volume group|Paired T-test|||||||=0.01
71727132|NCT02379988|142968203|EQUIVALENCE|Paired T-test|||||=|0.1||||||P-value for Small breast volume group|Paired T-test|||||||=0.10
71727133|NCT02379988|142968204|EQUIVALENCE|Wilcoxon test was used due to the non-normal distribution of the data|||||=|0.7776|||||||Wilcoxon (Mann-Whitney)|||||||=0.7776
71727134|NCT02089464|142968268|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
71727135|NCT02089464|142968269|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71727136|NCT02089464|142968270|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71727137|NCT02089464|142968271|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71831054|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.09||0.0029|TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.45|0.0029
71727138|NCT02089464|142968272|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71727139|NCT02089464|142968274|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71727140|NCT02089464|142968275|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71727141|NCT02089464|142968276|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
71727142|NCT00934947|142968283|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||.36
71727143|NCT00934947|142968284|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||.32
71727144|NCT00934947|142968285|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||.48
71727145|NCT01907321|142968286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.78|STANDARD_DEVIATION|14.98||0.001|TWO_SIDED||||||repeated measures ANOVA|||||||.001
71727146|NCT01907321|142968287|SUPERIORITY_OR_OTHER|||||||0.519|||||||ANOVA|||||||.519
71727147|NCT04049266|142968294|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4 ETDRS letters, i.e. the non-inferiority margin (NI) is 4 letters.|Adjusted mean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.01|>|0.9999|TWO_SIDED|95.03|-8.0|-4.0|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, categories for baseline BCVA, BCVA-low luminance VA baseline, geographical location.||||-4|-8|> 0.9999
71727148|NCT01703208|142968302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.77|1.29|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.29|0.77|
71727149|NCT01703208|142968303|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||||TWO_SIDED|95.0|-0.48|-0.37||||||||-0.37|-0.48|
71727150|NCT01703208|142968304|SUPERIORITY_OR_OTHER||Difference in the LS Means vs Placebo|-0.39|||<|0.001|TWO_SIDED|95.0|-0.5|-0.27|||Longitudinal data analysis|Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.||||-0.27|-0.50|<0.001
71727151|NCT01703208|142968305|SUPERIORITY_OR_OTHER||Difference in Percent vs. Placebo|-1.1|||||TWO_SIDED|95.0|-7.2|4.9|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||4.9|-7.2|
71727152|NCT01703208|142968306|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Placebo|0.3|||||TWO_SIDED|95.0|-1.0|1.7|||||Based on Miettinen \& Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||1.7|-1.0|
71727153|NCT01703208|142968308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.66|1.68|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.68|0.66|
71727154|NCT01703208|142968310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.6|1.26|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.26|0.60|
71727155|NCT01703208|142968312|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.58|1.52|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.52|0.58|
71727156|NCT01703208|142968314|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.88|1.85|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.85|0.88|
71727157|NCT01703208|142968315|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.3|||||TWO_SIDED|95.0|-0.46|-0.14|||||Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.|||-0.14|-0.46|
71727158|NCT01703208|142968321|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.1||||0.421|TWO_SIDED|95.0|-10.8|4.5|||Longitudinal constrained data analysis||Based on a LDA model including terms for treatment, time and the interaction of time by treatment.|||4.5|-10.8|0.421
71727159|NCT01703208|142968322|SUPERIORITY_OR_OTHER||Between group rate difference|11.9|||<|0.001|TWO_SIDED|95.0|6.9|16.8||Estimated using standard multiple imputation techniques.|Miettinen & Nurminen method|||||16.8|6.9|<0.001
71727160|NCT01703208|142968324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.35|1.05|||||Based on the proportional hazards model that includes treatment as an explanatory factor.|||1.05|0.35|
71727161|NCT04699032|142968342|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% confidence intervals (CIs) were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.62|||||TWO_SIDED|90.0|0.423|0.909||||||||0.909|0.423|
71727162|NCT04699032|142968343|OTHER|ANOVA was used to compare the natural log transformed AUCinf for apraglutide between normal renal function group (Reference) and the severe impaired renal group (Test). Estimates of the mean differences and corresponding 90% CIs were obtained from the model. The mean differences and 90% CIs for the mean differences were exponentiated to provide estimates of the geometric least-square mean ratio (Test/Reference) and 90% CIs for the ratios.|Geometric least-square mean ratio|0.694|||||TWO_SIDED|90.0|0.458|1.05||||||||1.050|0.458|
71727163|NCT01271712|142968346|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.||||<0.000001
71727164|NCT01271712|142968346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.268|||||TWO_SIDED|95.0|0.185|0.388|||Regression, Cox|stratified|regorafenib over placebo|Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model||0.388|0.185|
71727165|NCT01271712|142968347|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285777|||||||Log Rank|stratified||||||0.285777
71727166|NCT01271712|142968347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.909|||||TWO_SIDED|95.0|0.653|1.265|||Regression, Cox|stratified|regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.|Hazard ratio and its 95% CI was based on stratified Cox Regression Model||1.265|0.653|
71727167|NCT01271712|142968348|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-06|||||||Log Rank|stratified||||||<0.000001
71727168|NCT01271712|142968348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.248|||||TWO_SIDED|95.0|0.17|0.364|||Regression, Cox|stratified||||0.364|0.170|
71727169|NCT02684058|142968370|SUPERIORITY|one-sided p-value at 2.5% level of significance|Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.3|22.4|||Chi-squared|||||22.4|2.3|<0.001
71727170|NCT02684058|142968375|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|95.0|0.17|0.55||Log-rank test at an overall one-sided 2.5% level of significance|Log Rank|||Up to approx. 3 years||0.55|0.17|<0.001
71727171|NCT00443053|142968425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Fisher Exact|||||0.26|0.08|<0.001
71727172|NCT00443053|142968426|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.32|||Fisher Exact|||||0.32|0.12|<0.001
71727173|NCT00350272|142968436|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-13.5|||||TWO_SIDED|95.0|-35.2|8.2||||||The difference in proportions between the group of participants who received lamivudine 300 mg/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of participants who received elvucitabine 10 mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.||8.2|-35.2|
71727174|NCT01468207|142968440|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|15.9|||=|0.003|TWO_SIDED|95.0|5.3|26.5||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||||26.5|5.3|=0.003
71727175|NCT01468207|142968440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8|||=|0.048|TWO_SIDED|95.0|0.3|29.3|||Chi-squared|||||29.3|0.3|=0.048
71727176|NCT01468207|142968440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.1|||=|0.027|TWO_SIDED|95.0|2.2|32.1|||Chi-squared|||||32.1|2.2|=0.027
71727177|NCT01468207|142968441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||=|0.961|TWO_SIDED|95.0|-13.4|14.1|||Chi-squared|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.1|-13.4|=0.961
71727178|NCT01468207|142968442|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|2.8|||=|0.628|TWO_SIDED|95.0|-8.6|14.2||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||14.2|-8.6|=0.628
71727179|NCT01468207|142968443|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.7|||=|0.124|TWO_SIDED|95.0|-19.7|2.4|||ANCOVA|P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||2.4|-19.7|=0.124
71727180|NCT00322023|142968467|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|These are paired t test baseline vs final for the 30 mg/kg dose||||||<0.0001
71727181|NCT00322023|142968467|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|These are paired t test baseline vs final for the 60 mg/kg dose||||||<0.05
71771032|NCT01857310|143041580|SUPERIORITY||Risk Ratio (RR)|1.99|||||TWO_SIDED|95.0|0.18|21.9|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Major neonatal complications will be compared using two sided tests conducted at the 0.05 level."||21.9|0.18|
71771033|NCT01857310|143041581|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.8|1.0|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||1.0|-0.8|
71771034|NCT01857310|143041581|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.53|2.21|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Structural malformations will be compared using two sided tests conducted at the 0.05 level."||2.21|0.53|
71771035|NCT01857310|143041582|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||1.3|-0.4|
71727182|NCT00322023|142968467|SUPERIORITY|These are paired t test baseline vs final for the 120 mg/kg dose|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71727183|NCT00322023|142968468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|TWO_SIDED|95.0||||These are paired t test baseline vs final for 30mg/kg|t-test, 2 sided|||||||0.39
71727184|NCT00322023|142968468|SUPERIORITY||||||<|0.001||||||These are paired t test baseline vs final for 60mg/kg|t-test, 2 sided|||||||<0.001
71727185|NCT00322023|142968468|SUPERIORITY|||||||0.01||||||These are paired t test baseline vs final for 120mg/kg|t-test, 2 sided|||||||0.01
71727186|NCT01180036|142968504|SUPERIORITY||Risk Difference (RD)|40.0||||0.001|TWO_SIDED|95.0|24.6|55.4|||Chi-squared|||||55.4|24.6|0.001
71727187|NCT01180036|142968505|NON_INFERIORITY|With a non-inferiority margin of 15%. enrollment of 63 evaluable patients per study are is required to achieve 80% power to show that RTX is not inferior.||||||0.009|||||||Chi-squared|||||||0.009
71727188|NCT04243577|142968506|EQUIVALENCE|Margins for this test were calculated as plus or minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and were ± 3.1.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 2 sided|||For Iteration 1 testing, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71727189|NCT04243577|142968506|EQUIVALENCE|Margins for this test were based on the absolute value of the effect size (Cohen's d) being smaller than 0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a Confidence Interval for Cohen's d.||For Iteration 2 testing again, we hypothesized that normalized amplitude during swallow trials obtained using the conventional sensors and the experimental sensors will be equivalent. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71727190|NCT04243577|142968507|NON_INFERIORITY|Margin for this test was calculated as minus half a standard deviation using preliminary data acquired with the conventional electrodes, which were considered as the current gold standard and was -.99.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|t-test, 1 sided|||For Iteration 1 testing, we hypothesized that Signal to Noise Ratio (SNR) obtained using the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71727191|NCT04243577|142968507|NON_INFERIORITY|Margin for this test was based on the effect size (Cohen's d) being larger than -0.5.|||||<|0.025||||||Alpha level based on Bonferroni correction was set to .025 to correct for multiple comparisons.|Bootstrapping CIs|In this 2nd iteration testing, we are accounting for variance uncertainty, and thus bootstrapping a one-sided confidence bound for Cohen's d.||For Iteration 2 testing, we again hypothesized that Signal to Noise Ratio (SNR) obtained using the newer version of the experimental sensors will not be inferior to the Signal to Noise Ratio (SNR) obtained using the conventional sensors. Alpha level was set to .025 to correct for multiple comparisons.||||<0.025
71727192|NCT04243577|142968508|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 1 testing, we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
71727193|NCT04243577|142968508|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|Paired t-test||For Iteration 2 testing, again we hypothesized that ease of use/comfort expressed after using the experimental patch will be higher than the one reported using the conventional electrodes. Alpha level was set to .05.||||<0.05
71727194|NCT01679600|142968510|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||F1-LD-F1 model by Brunner and Langer|||||||0.53
71727195|NCT01685801|142968511|SUPERIORITY_OR_OTHER||Posterior Mean|2.251|STANDARD_DEVIATION|0.961|||TWO_SIDED|95.0|0.383|4.144|||||The posterior distribution of overall treatment difference was obtained using the Bayesian hierarchical model and 95% credible interval of the treatment effect (posterior mean) was calculated.|"This statistical analysis is for Overall category."||4.144|0.383|
71727196|NCT04686084|142968533|OTHER|Bland-Altman analysis|Median Difference (Final Values)|0.04|||||TWO_SIDED|||||||||||||
71727197|NCT04452435|142968560|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4891|||||||ANCOVA|||||||=0.4891
71727198|NCT04452435|142968560|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0881|||||||ANCOVA|||A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.||||=0.0881
71727199|NCT04452435|142968561|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0492|||||||ANCOVA|||||||=0.0492
71727200|NCT04452435|142968562|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9923|||||||ANCOVA|||||||=0.9923
71727201|NCT04452435|142968563|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5355|||||||ANCOVA|||||||=0.5355
71727202|NCT04452435|142968564|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.4738|||||||ANCOVA|||||||=0.4738
71727203|NCT04452435|142968565|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9418|||||||ANCOVA|||||||=0.9418
71727204|NCT04452435|142968566|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.9733|||||||ANCOVA|||||||=0.9733
71727205|NCT04452435|142968567|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.0568|||||||Regression, Logistic|||||||=0.0568
71727206|NCT04452435|142968568|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.6088|||||||Regression, Logistic|||||||=0.6088
71771036|NCT01857310|143041582|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.68|3.32|||||Adjusted for infertility treatment stratum and study site.|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Severe maternal morbidity will be compared using two sided tests conducted at the 0.05 level."||3.32|0.68|
71727207|NCT04452435|142968569|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.5757|||||||Log Rank|||||||=0.5757
71727208|NCT04452435|142968570|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.8588|||||||Wilcoxon (Mann-Whitney)|||||||=0.8588
71727209|NCT04452435|142968572|EQUIVALENCE|The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.|||||=|0.003|||||||Chi-squared|||||||=0.003
71727210|NCT01155466|142968581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.62|0.53|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated mean change from baseline in mean off time for preladenant 10 mg - placebo."|||0.53|-0.62|0.8700
71727211|NCT01155466|142968583|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.899|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 2 mg - placebo|||1.6|-7.3|0.899
71727212|NCT01155466|142968583|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.815|TWO_SIDED|95.0|-6.8|2.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 5 mg - placebo|||2.6|-6.8|0.815
71727213|NCT01155466|142968583|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4||||0.295|TWO_SIDED|95.0|-3.9|6.9|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure \>=105 mm Hg for preladenant 10 mg - placebo|||6.9|-3.9|0.295
71727214|NCT01155466|142968586|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.629|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 2 mg - placebo|||3.7|-5.1|0.629
71727215|NCT01155466|142968586|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.625|TWO_SIDED|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 5 mg - placebo|||3.7|-5.1|0.625
71727216|NCT01155466|142968586|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.6||||0.948|TWO_SIDED|95.0|-6.8|0.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 10 mg - placebo|||0.7|-6.8|0.948
71727217|NCT01155466|142968587|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1||||0.7044|TWO_SIDED|95.0|-0.61|0.9|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 2 mg - placebo|||0.90|-0.61|0.7044
71727218|NCT01155466|142968587|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.3439|TWO_SIDED|95.0|-0.4|1.14|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 5 mg - placebo|||1.14|-0.4|0.3439
71727219|NCT01155466|142968587|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3||||0.3941|TWO_SIDED|95.0|-0.43|1.08|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 10 mg - placebo|||1.08|-0.43|0.3941
71727220|NCT01155466|142968588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.983|TWO_SIDED|95.0|0.597|1.657|||Mixed Models Analysis|Odds ratio was calculated for all randomized and treated participants with at least 1 post treatment value.|"Confidence intervals and P-values were based on a generalized linear mixed model with baseline average off time as a covariate and treatment-by-time interaction as fixed effect and participant as random effect."|||1.657|0.597|0.983
71727221|NCT01155466|142968589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6405|TWO_SIDED|95.0|-0.49|0.8|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated change from baseline in on time without troublesome dyskinesias for preladenant 10 mg - placebo."|||0.80|-0.49|0.6405
71727222|NCT03119181|142968591|SUPERIORITY|||||||0.0097|||||||one-sided permutation test|||one-sided permutation test at 2.5% significance||||0.0097
71727223|NCT00557310|142968606|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|||||||0.363
71727224|NCT00557310|142968607|SUPERIORITY_OR_OTHER|||||||0.837||95.0|||||Mixed Model Repeated Measurements|||||||0.837
71727225|NCT00557310|142968608|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measurements|||||||0.816
71727226|NCT00557310|142968608|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.934
71727227|NCT00557310|142968609|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measures|||||||0.324
71727228|NCT00557310|142968609|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measures|||||||0.089
71727229|NCT00557310|142968610|SUPERIORITY_OR_OTHER|||||||0.847||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.847
71727230|NCT00557310|142968610|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.212
71727231|NCT00557310|142968611|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 3 months.||||||0.335
71727232|NCT00557310|142968611|SUPERIORITY_OR_OTHER|||||||0.916||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.916
71727233|NCT00557310|142968611|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for the percent change from baseline at 12 months.|Mixed Model Repeated Measurements|||||||0.610
71727234|NCT00557310|142968611|SUPERIORITY_OR_OTHER|||||||0.363||95.0|||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.||||||0.363
71727235|NCT00557310|142968611|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.837
71727236|NCT00557310|142968612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71727237|NCT00557310|142968613|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||ANOVA|||||||0.021
71727238|NCT00557310|142968614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71727239|NCT00557310|142968615|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
71727240|NCT00557310|142968616|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||<0.001
71727241|NCT00557310|142968616|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||<0.001
71727242|NCT00557310|142968617|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.011
71727243|NCT00557310|142968617|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.049
71727244|NCT00557310|142968618|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.700
71727245|NCT00557310|142968618|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.092
71727246|NCT00557310|142968619|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.013
71727247|NCT00557310|142968619|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.005
71727248|NCT00557310|142968620|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||P-value is for the percent change from baseline at 18 months.|ANOVA|||||||0.106
71727249|NCT00557310|142968620|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for the percent change from baseline at 24 months.|ANOVA|||||||0.436
71727250|NCT00557310|142968621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||<0.001
71727251|NCT00557310|142968621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||<0.001
71727252|NCT00557310|142968621|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||<0.001
71727253|NCT00557310|142968622|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements|||||||0.012
71727254|NCT00557310|142968622|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements|||||||0.012
71727255|NCT00557310|142968622|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements|||||||0.016
71888560|NCT00132041|143298083|OTHER||Success rate|0.18|||||TWO_SIDED|95.0|0.091|0.317|||||logistic regression model without correcting for the clustering effect|logistic regression was used to estimate the success rate||0.317|0.091|
71727256|NCT00367744|142968627|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment groups were compared for change in limb fat using a two-sided signed rank test||The primary outcome measure was the change in limb fat at 48 weeks between the rosiglitazone and placebo group.||||0.02
71727257|NCT04270682|142968711|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed urine 23S-pentol in the adult cohort.|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|0.332|<|0.0001|TWO_SIDED|95.0|-3.794|-2.331|||paired t-test|||||-2.331|-3.794|<0.0001
71727258|NCT04270682|142968712|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed plasma cholestanol in the adult cohort.|Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.241||0.0083|TWO_SIDED|95.0|-1.64|-0.399|||paired t-test|||||-0.399|-1.640|0.0083
71727259|NCT04270682|142968713|EQUIVALENCE|The null (H0) hypothesis and the alternative (Ha) hypothesis to be tested for the primary efficacy endpoint are that H0: Δ = 0 versus Ha: Δ ≠ 0 where Δ is the true paired treatment difference between CDCA and placebo for the change from baseline in loge-transformed Plasma 7αC4 in the adult cohort.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.224|<|0.0001|TWO_SIDED|95.0|-4.193|-3.207|||paired t-test|||||-3.207|-4.193|<0.0001
71727260|NCT04270682|142968714|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.077||||0.0006|TWO_SIDED|95.0|0.0|0.36|||Prescott's|||||0.36|0.00|0.0006
71727261|NCT04270682|142968714|EQUIVALENCE|Exact 2 sided p-value for observing contingency tables of rescue data with equal or more extreme values is calculated using Prescott's method. Rejection of the null hypothesis for no association suggests there is a difference between two treatments.|proportion|0.62||||0.0006|TWO_SIDED|95.0|0.32|0.86|||Prescott's|||||0.86|0.32|0.0006
71727262|NCT05479097|142968715|SUPERIORITY||Median Difference (Net)|-7.5||||0.03232|TWO_SIDED|95.0|-12.0|-1.0||A priori threshold for statistical significance was P \<0.05.|Wilcoxon signed rank test|Systolic blood pressure was not normally distributed in the study sample, so nonparametric analysis was used.||The null hypothesis was that there was no change in systolic blood pressure.||-1.0|-12.0|0.03232
71727263|NCT05479097|142968716|SUPERIORITY||Mean Difference (Net)|-3.1||||0.045|TWO_SIDED|95.0|-6.1|-0.1||The a priori threshold for statistical significance was P \<0.05.|t-test, 2 sided|As diastolic blood pressure was normally distributed in our sample, we used a paired t-test to evaluate the mean difference in measurements.||The null hypothesis was that there was no change in diastolic blood pressure.||-0.1|-6.1|0.045
71727264|NCT05479097|142968717|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was no change in the proportion of patients with systolic blood pressure well-controlled (\<=140 mmHg) from baseline to 6 months.||||0.7237
71727265|NCT05479097|142968718|SUPERIORITY|||||||0.7237||||||The a priori threshold for statistical significance was P \<0.05|McNemar|||The null hypothesis was that there was no difference in the proportion of patients with systolic blood pressure less than or equal to their personalized goal from baseline to 6 months.||||0.7237
71727266|NCT03894969|142968752|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PD is \> 0.667. The anti-PD GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.942|||||TWO_SIDED|0.95|0.765|1.159|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.159|0.765|
71727267|NCT03894969|142968752|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PE is \> 0.667. The anti-PE GMC ratio is presented in this test with its 95% CI.|GMC ratio|0.887|||||TWO_SIDED|0.95|0.719|1.093|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.093|0.719|
71727268|NCT03894969|142968752|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-PilA is \> 0.667. The anti-PilA GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.142|||||TWO_SIDED|0.95|0.884|1.474|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.474|0.884|
71771037|NCT01857310|143041583|SUPERIORITY||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-7.9|3.23||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Fertilization rate will be compared using generalized estimating equations accounting for multiple cycles per couple."||3.23|-7.90|
71727269|NCT03894969|142968752|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the GMC ratio for anti-UspA2 is \> 0.667. The anti-UspA2 GMC ratio is presented in this test with its 95% CI.|GMC ratio|1.087|||||TWO_SIDED|0.95|0.948|1.245|||ANCOVA|ANCOVA model with treatment group, age category, smoking status and center as fixed effects and pre-Dose 1 log-concentration as a covariate.||To demonstrate the non-inferiority (NI) of the humoral immune response 1 month after Dose 2 of GSK Biologicals' NTHi-Mcat investigational vaccine when administered 1 after Shingrix vaccine versus the humoral immune response 1 month after Dose 2 of GSKBiologicals' NTHi-Mcat investigational vaccine alone.||1.245|0.948|
71727270|NCT03569748|142968769|NON_INFERIORITY|Margin=0.04|Proportion Difference|0.1342||||0.0051|TWO_SIDED|95.0|0.0014|0.2671|||Chi-squared, Corrected|||H0: P1-P2 ≤ -Margin||0.2671|0.0014|0.0051
71727271|NCT03569748|142968770|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
71727272|NCT03569748|142968771|SUPERIORITY||Percentage Difference|14.2||||0.0003|TWO_SIDED||||||Chi-squared, Corrected|||||||0.0003
71727273|NCT00468676|142968776|SUPERIORITY_OR_OTHER||scaled marginal model parameter|-1.57|STANDARD_ERROR_OF_MEAN|0.28||0.001|TWO_SIDED|95.0|-2.12|-1.02||Significance of the four outcome composite|Scaled Marginal Model||Intervention group had significantly lower scaled marginal mean scores than usual care|||-1.02|-2.12|.001
71727274|NCT00468676|142968777|SUPERIORITY_OR_OTHER||Slope|0.01|||<|0.01||95.0|||||general estimating equations|||Disability outcomes were measured at six and 12 months after randomization using linear regression models adjusted for baseline values. The disability models combined information across time points and were estimated using general estimating equations to account for correlation. All analyses were based on intent to treat principles||||<0.01
71727275|NCT00468676|142968779|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.26|-0.56|<0.001
71727276|NCT00468676|142968780|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-3.4|||||TWO_SIDED|95.0|-6.9|0.1|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||0.1|-6.9|
71727277|NCT00468676|142968781|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-9.1|||||TWO_SIDED|95.0|-17.5|-0.8|||Regression, Linear||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a linear-regression model predicting a 12-month outcome.|||-0.8|-17.5|
71727278|NCT00468676|142968782|SUPERIORITY_OR_OTHER||Estimated Between Group Difference|-0.56|||||TWO_SIDED|95.0|-0.85|-0.27|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.|||-0.27|-0.85|
71727279|NCT00118846|142968795|SUPERIORITY||Slope|-0.91||||0.35|TWO_SIDED|95.0|-2.86|1.05|||Mixed Models Analysis||Slope = Mean difference in annualized rate of change|||1.05|-2.86|0.35
71727280|NCT00118846|142968796|OTHER||Mean Difference (Net)|0.11||||0.36|TWO_SIDED|95.0|-0.13|0.35|||ANCOVA|||||0.35|-0.13|0.36
71727281|NCT01574157|142968815|SUPERIORITY||Mean Difference (Final Values)|12.6|||||TWO_SIDED|95.0|-9.6|40.1||||||The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||40.1|-9.6|
71727282|NCT01574157|142968816|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-38.2|30.8||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||30.8|-38.2|
71727283|NCT01574157|142968817|SUPERIORITY||Mean Difference (Final Values)|-32.5|||||TWO_SIDED|95.0|-56.3|4.2||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||4.2|-56.3|
71727284|NCT01574157|142968818|SUPERIORITY||Mean Difference (Final Values)|7.7|||||TWO_SIDED|95.0|-15.1|36.5||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||36.5|-15.1|
71727285|NCT01574157|142968819|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-24.6|35.9||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||35.9|-24.6|
71727286|NCT01574157|142968820|SUPERIORITY||Mean Difference (Final Values)|3.37|||||TWO_SIDED|95.0|-0.05|6.79||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.||6.79|-0.05|
71727287|NCT02956044|142968830|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|108.73|||||TWO_SIDED|95.0|94.35|125.3|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric Least Square (LS) Mean was used as PK parameters||125.30|94.35|
71727288|NCT02956044|142968830|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|95.05|||||TWO_SIDED|90.0|84.73|106.63|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||106.63|84.73|
71727289|NCT02956044|142968830|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|89.44|||||TWO_SIDED|90.0|70.39|113.65|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||113.65|70.39|
71727290|NCT02956044|142968830|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|111.95|||||TWO_SIDED|90.0|97.02|129.19|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||129.19|97.02|
71727291|NCT02956044|142968830|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|126.68|||||TWO_SIDED|90.0|112.08|143.17|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||143.17|112.08|
71727292|NCT02956044|142968830|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|98.48|||||TWO_SIDED|90.0|84.9|114.23|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||114.23|84.90|
71727293|NCT02956044|142968833|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|87.36|||||TWO_SIDED|90.0|80.02|95.38|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||95.38|80.02|
71727294|NCT02956044|142968833|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|103.24|||||TWO_SIDED|90.0|94.59|112.68|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||112.68|94.59|
71727295|NCT02956044|142968833|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|Ratio of Geometric LSM|94.46|||||TWO_SIDED|90.0|80.34|111.06|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||111.06|80.34|
71727296|NCT02956044|142968833|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|[Ratio of Geometric LSM]|127.19|||||TWO_SIDED|90.0|110.33|146.62|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||146.62|110.33|
71727297|NCT02956044|142968833|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|113.09|||||TWO_SIDED|90.0|107.61|118.86|||||Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|Geometric LS Mean was used as PK parameters||118.86|107.61|
71727298|NCT02956044|142968833|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%|[Ratio of Geometric LSM]|103.16|||||TWO_SIDED|90.0|99.3|107.17||||||Geometric LS Mean was used as PK parameters|Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subject as a random effect|107.17|99.30|
71727299|NCT03955250|142968882|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71727300|NCT03955250|142968883|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
71727301|NCT03955250|142968883|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
71727302|NCT03955250|142968884|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|time||||||>0.05
71727303|NCT03955250|142968884|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
71727304|NCT03955250|142968885|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|time||||||<0.05
71727305|NCT03955250|142968885|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|condition||||||>0.05
71727306|NCT00433160|142968889|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.|t-test, 2 sided|||Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.||||<0.001
71727307|NCT00433160|142968893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.||||<0.001
71727308|NCT00433160|142968893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.||||<0.001
71727309|NCT00433160|142968893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.||||<0.001
71727310|NCT00433160|142968893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.||||<0.001
71727311|NCT00433160|142968893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.||||<0.001
71727312|NCT00433160|142968894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.||||<0.001
71727313|NCT00433160|142968894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.||||<0.001
71727314|NCT00433160|142968894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.||||<0.001
71727315|NCT00433160|142968894|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wicoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.||||0.060
71727316|NCT00433160|142968894|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.||||0.130
71727317|NCT00433160|142968895|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.||||0.976
71727318|NCT00433160|142968895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.||||<0.001
71658436|NCT00505375|142831864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.0014
71658437|NCT03709823|142831865|SUPERIORITY||LS Mean Difference vs. Placebo|-20.48||||0.0002|TWO_SIDED|95.0|-31.141|-9.821||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-9.821|-31.141|0.0002
71658438|NCT03709823|142831865|SUPERIORITY||LS Mean Difference vs. Placebo|-22.07|||<|0.0001|TWO_SIDED|95.0|-32.791|-11.342||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-11.342|-32.791|< 0.0001
71658439|NCT03709823|142831865|SUPERIORITY||LS Mean Difference vs. Placebo|-5.9||||0.2708|TWO_SIDED|95.0|-16.463|4.66||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||4.660|-16.463|0.2708
71658440|NCT03709823|142831865|SUPERIORITY||LS Mean Difference vs. Placebo|-2.81||||0.6018|TWO_SIDED|95.0|-13.438|7.82||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||7.820|-13.438|0.6018
71658441|NCT03709823|142831865|SUPERIORITY||LS Mean Difference vs. Commercial Sched.|-12.17||||0.1025|TWO_SIDED|95.0|-26.869|2.535||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||2.535|-26.869|0.1025
71658442|NCT03709823|142831866|SUPERIORITY||LS Mean Difference vs. Placebo|-14.61||||0.001|TWO_SIDED|95.0|-23.216|-6.009||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-6.009|-23.216|0.0010
71658443|NCT03709823|142831866|SUPERIORITY||LS Mean Difference vs. Placebo|-16.2||||0.0003|TWO_SIDED|95.0|-24.862|-7.548||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-7.548|-24.862|0.0003
71658444|NCT03709823|142831867|SUPERIORITY||LS Mean Difference vs. Placebo|-12.41||||0.0091|TWO_SIDED|95.0|-21.695|-3.135||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||-3.135|-21.695|0.0091
71658445|NCT03709823|142831867|SUPERIORITY||LS Mean Difference vs. Placebo|-9.3||||0.0518|TWO_SIDED|95.0|-18.667|0.075||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA|||||0.075|-18.667|0.0518
71658446|NCT04870138|142831917|OTHER|||||||1||||||One-sided Fisher's Exact Test with alpha = 0.05|Fisher Exact|||||||1.000
71658447|NCT04870138|142831919|OTHER||||||<|0.0001|||||||t-test, 1 sided|One-sided single sample t-test with alpha=0.05||Null hypothesis: The proportion of the strain in the inoculum = 0.5||||<0.0001
71658448|NCT01194973|142831992|SUPERIORITY_OR_OTHER||LS mean change from baseline|117.68|||<|0.0001|TWO_SIDED|95.0|92.77|142.59|||ANOVA|||||142.59|92.77|<0.0001
71658449|NCT01194973|142831998|SUPERIORITY_OR_OTHER||LS mean change from baseline|102.49|||<|0.0001|TWO_SIDED|95.0|68.15|136.82|||ANOVA|||||136.82|68.15|<0.0001
71658450|NCT02615171|142832062|OTHER|||||||0.0106|||||||t-test, 2 sided|||||||0.0106
71658451|NCT02615171|142832063|OTHER|||||||0.0027|||||||Chi-squared|||||||0.0027
71658452|NCT02615171|142832064|OTHER|||||||0.7829|||||||Wilcoxon rank sum test|||||||0.7829
71658453|NCT00888459|142832075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||Chi-squared|||||||.432
71658454|NCT01000493|142832076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.62||||0.3624|TWO_SIDED|95.0|-17.9|6.65||The mixed effects model repeated measures (MMRM) analysis included treatment, week, Baseline total CAPS score and the treatment by week and Baseline. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between Placebo and Orvepitant 60 mg at Week 12.|||6.65|-17.9|0.3624
71658455|NCT01000493|142832077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.3156|TWO_SIDED|95.0|0.54|6.76|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||6.76|0.54|0.3156
71658456|NCT01000493|142832077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.3024|TWO_SIDED|95.0|0.27|1.5|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||1.50|0.27|0.3024
71658457|NCT01000493|142832077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.1208|TWO_SIDED|95.0|0.79|7.28|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 8. Odds ratios represent the odds of improvement, relative to placebo.|||7.28|0.79|0.1208
71658458|NCT01000493|142832077|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27||||0.1331|TWO_SIDED|95.0|0.7|15.4|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.|||15.4|0.70|0.1331
71658459|NCT01000493|142832079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.7015|TWO_SIDED|95.0|-5.35|3.61||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||3.61|-5.35|0.7015
71727319|NCT00433160|142968895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.||||<0.001
71727320|NCT00433160|142968895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.||||<0.001
71727321|NCT00433160|142968895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.||||<0.001
71727322|NCT02499900|142968914|SUPERIORITY||Mean Difference (Final Values)|0.321|||<|0.001|TWO_SIDED|95.0|0.1615|0.4814||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as MSQ is not measured at baseline for these patients.||0.4814|0.1615|<0.001
71727323|NCT02499900|142968915|SUPERIORITY||Mean Difference (Final Values)|9.448|||<|0.001|TWO_SIDED|95.0|6.9538|11.9429||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: TSQM-9 convenience score=baseline TSQM-9 convenience score+treatment+CGR+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as TSQM-9 is not measured at baseline for these patients.||11.9429|6.9538|<0.001
71727324|NCT02499900|142968916|SUPERIORITY||Mean Difference (Final Values)|-0.802||||0.208|TWO_SIDED|95.0|-2.05|0.4461||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.4461|-2.0500|0.208
71727325|NCT02499900|142968916|SUPERIORITY||Mean Difference (Final Values)|-0.231||||0.47|TWO_SIDED|95.0|-0.8588|0.3962||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Physical Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.3962|-0.8588|0.470
71727326|NCT02499900|142968916|SUPERIORITY||Mean Difference (Final Values)|-0.639||||0.043|TWO_SIDED|95.0|-1.2564|-0.0214||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Cognitive Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||-0.0214|-1.2564|0.043
71727327|NCT02499900|142968916|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.237|TWO_SIDED|95.0|-0.0672|0.2711||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Psychosocial Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.||0.2711|-0.0672|0.237
71727328|NCT02499900|142968917|SUPERIORITY||Mean Difference (Final Values)|0.706||||0.287|TWO_SIDED|95.0|-0.5947|1.0074||0.05 level of significance|Repeated Measures ANCOVA|||Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.0074|-0.5947|0.287
71727329|NCT02499900|142968917|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.868|TWO_SIDED|95.0|-1.5179|1.7991||0.05 level of significance|Repeated Measures ANCOVA|||Anxiety subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.7991|-1.5179|0.868
71727330|NCT02499900|142968917|SUPERIORITY||Mean Difference (Final Values)|0.481||||0.544|TWO_SIDED|95.0|-1.0734|2.0348||0.05 level of significance|Repeated Measures ANCOVA|||Depression subscale estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||2.0348|-1.0734|0.544
71727331|NCT02499900|142968917|SUPERIORITY||Mean Difference (Final Values)|1.867||||0.014|TWO_SIDED|95.0|0.3843|3.3487||0.05 level of significance|Repeated Measures ANCOVA|||Behavioral Control subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||3.3487|0.3843|0.014
71727332|NCT02499900|142968917|SUPERIORITY||Mean Difference (Final Values)|-0.092||||0.919|TWO_SIDED|95.0|-1.8565|1.6728||0.05 level of significance|Repeated Measures ANCOVA|||MHI Positive Affect subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.||1.6728|-1.8565|0.919
71727333|NCT02499900|142968918|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.851|TWO_SIDED|95.0|-0.6777|0.5592||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline BDI-II total score=baseline BDI-II total score+treatment+visit+country/geographic region +treatment by visit interaction.||0.5592|-0.6777|0.851
71727334|NCT02793817|142968920|SUPERIORITY||Difference in percentage of responders|8.3||||0.0105|TWO_SIDED|95.0|2.0|14.7||To account for multiplicity, a step-down testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared tests (unadjusted) wherein the a priori significance level was 0.05.||14.7|2.0|0.0105
71727335|NCT02793817|142968921|SUPERIORITY||Difference in percentage of responders|20.0|||<|0.0001|TWO_SIDED|95.0|11.6|28.4||To account for multiplicity, a step-down closed testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared test (unadjusted), wherein a priori significance level was 0.05||28.4|11.6|<0.0001
71727336|NCT02793817|142968922|SUPERIORITY||Difference in percentage of responders|17.1|||<|0.0001|TWO_SIDED|95.0|9.1|25.0||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||25.0|9.1|<0.0001
71727337|NCT02793817|142968923|SUPERIORITY||Difference in percentage of responders|19.0|||<|0.0001|TWO_SIDED|95.0|11.0|26.9||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|||26.9|11.0|<0.0001
71727338|NCT02793817|142968924|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0078|TWO_SIDED|95.0|-0.31|-0.05|||Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for change from BL.|P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.||-0.05|-0.31|0.0078
71727339|NCT02793817|142968925|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.0005|TWO_SIDED|95.0|-0.38|-0.11||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without any adjustment for covariates|Estimated Value is the between-group difference in change from BL|||-0.11|-0.38|0.0005
71727340|NCT02793817|142968926|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.0169|TWO_SIDED|95.0|-0.28|-0.03||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without adjustments for any covariates.|Estimated Value is the between-group difference for change from BL|||-0.03|-0.28|0.0169
71727341|NCT03222973|142968927|SUPERIORITY||Treatment Difference|0.15||||0.1479|TWO_SIDED|95.0|-0.05|0.35||P-values are based on the Mixed Model for Repeated Measures (MMRM) adjusted for background DMT group, baseline magnetization transfer ratio (MTR)/diffusion tensor imaging (DTI) category and baseline component assessments.|MMRM|||Over 72 weeks: Overall Response Score||0.35|-0.05|0.1479
71727342|NCT03222973|142968929|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7682|TWO_SIDED|95.0|0.65|1.79||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.79|0.65|0.7682
71727343|NCT03222973|142968930|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2131|TWO_SIDED|95.0|0.41|1.22||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.22|0.41|0.2131
71727344|NCT03222973|142968931|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4654|TWO_SIDED|95.0|0.47|1.41||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||1.41|0.47|0.4654
71727345|NCT03222973|142968932|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0417|TWO_SIDED|95.0|1.02|3.11||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||3.11|1.02|0.0417
71727346|NCT03222973|142968933|SUPERIORITY||Odds Ratio (OR)|1.35||||0.2908|TWO_SIDED|95.0|0.78|2.33||Odds ratio (active vs. placebo), 95% CI and p-value are based on logistic regression adjusted for background DMT group, baseline MTR/DTI category and baseline component assessments.|Regression, Logistic|||||2.33|0.78|0.2908
71727347|NCT02080481|142968945|SUPERIORITY_OR_OTHER||ratio of geometric means|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76|||Regression, Linear|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the linear regression model.||||0.76|0.61|< 0.001
71727348|NCT02080481|142968946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.56|TWO_SIDED|98.3|0.25|9.6|||Regression, Logistic|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the logistic regression model.|Odds ratio for Infiniti Plus versus conventional needle patients|||9.6|0.25|0.56
71727349|NCT02080481|142968947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13||||0.06|TWO_SIDED|98.3|0.01|1.78||Intraoperative management strategy was imbalanced between groups and adjusted for in the logistic regression model.|Regression, Logistic|||||1.78|0.01|0.06
71727350|NCT02080481|142968948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.74|TWO_SIDED|98.3|-7.7|14.6|||Regression, Linear|Intraoperative management strategy was imbalanced between randomized groups and adjusted for in the linear regression model.||||14.6|-7.7|0.74
71727351|NCT03895632|142968952|OTHER|A linear mixed-effects model was fit to assess the association between α (the slope of the Power Spectral Density (PSD) plot) and signal segment.|||||<|0.0001||||||p-value obtained form the Wald statistics of the linear mixed-effects model. The threshold for statistical signifiance was p=0.01.|Linear mixed-effects model|||The null hypothesis was that α (the slope of the Power Spectral Density (PSD) plot) is not related to signal segment (off-, approaching- and on-target).||||<0.0001
71727352|NCT03002818|142969013|SUPERIORITY||mean change|-108266.0||||0.091|TWO_SIDED|95.0|-235037.0|18504.0|||one-sample t-test|||sdITT (n=26): Change at Day 168 minus Baseline||18504|-235037|0.091
71727353|NCT03002818|142969013|SUPERIORITY||mean change|-98373.0||||0.152|TWO_SIDED|95.0|-235667.0|38921.0|||one-sample t-test|||mITT (n=24): Change at Day 168 minus Baseline||38921|-235667|0.152
71727354|NCT03002818|142969013|SUPERIORITY|||||||0.091|||||||paired t-test|||sdITT (n=26): Baseline vs. Day 168||||0.091
71727355|NCT03002818|142969013|SUPERIORITY|||||||0.152|||||||paired t-test|||mITT (n=24): Baseline vs. Day 168||||0.152
71727356|NCT03002818|142969014|SUPERIORITY|||||||0.461|||||||paired t-test|||sdITT (n=34): Baseline vs. Day 28||||0.461
71727357|NCT03002818|142969014|SUPERIORITY|||||||0.63|||||||paired t-test|||mITT (n=24): Baseline vs. Day 28||||0.630
71727358|NCT03002818|142969014|SUPERIORITY|||||||0.855|||||||paired t-test|||sdITT (n=32): Baseline vs. Day 84||||0.855
71658460|NCT01000493|142832079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.81||||0.4292|TWO_SIDED|95.0|-4.22|9.84||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||9.84|-4.22|0.4292
71888561|NCT00132041|143298083|OTHER||Slope|-3.7913||||0.0004|TWO_SIDED|95.0|-5.9056|-1.6769|||Generlaized estimating equations|Multivariate logistic model. P-value for number of RFA sessions dichotomized 1: more than 1; using the latter as the reference.|This estimate is for the effect of a single RFA sessions (v multiple sessions) in the multivariate model response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.|multivariate logistic regression model was fit using GEEs to correct for site clustering effects, in which, the response variable was success/failure at 18 months and the covariates were tumor size, whether or not a patient received repeated RFA, whether or not a local tumor recurrence occurred, whether or not a remote tumor occurrence occurred, and two common confounding factors - age and gender||-1.6769|-5.9056|0.0004
71727359|NCT03002818|142969014|SUPERIORITY|||||||0.75|||||||paired t-test|||mITT (n=24): Baseline vs. Day 84||||0.750
71727360|NCT03002818|142969015|SUPERIORITY||mean change|2.6|||||TWO_SIDED|95.0|2.063|3.137||||||sdITT: mean change Baseline minus Day 168||3.137|2.063|
71727361|NCT03002818|142969015|SUPERIORITY||mean change|2.82|||||TWO_SIDED|95.0|2.212|3.428||||||mITT: mean change Baseline minus Day 168||3.428|2.212|
71727362|NCT03002818|142969015|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||<0.001
71727363|NCT03002818|142969015|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||<0.001
71727364|NCT03002818|142969015|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||<0.001
71727365|NCT03002818|142969015|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||<0.001
71727366|NCT03002818|142969015|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||<0.001
71727367|NCT03002818|142969015|SUPERIORITY||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=23): Baseline vs. Day 84||||<0.001
71727368|NCT03002818|142969016|SUPERIORITY||mean change|0.61|||||TWO_SIDED|95.0|-0.651|1.871||||||sdITT: mean change Baseline minus Day 168||1.871|-0.651|
71727369|NCT03002818|142969016|SUPERIORITY||mean change|0.74|||||TWO_SIDED|95.0|-0.608|2.088||||||mITT: mean change Baseline minus Day 168||2.088|-0.608|
71727370|NCT03002818|142969016|SUPERIORITY|||||||0.381|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168||||0.381
71727371|NCT03002818|142969016|SUPERIORITY|||||||0.304|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168||||0.304
71727372|NCT03002818|142969016|SUPERIORITY|||||||0.014|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28||||0.014
71727373|NCT03002818|142969016|SUPERIORITY|||||||0.278|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28||||0.278
71727374|NCT03002818|142969016|SUPERIORITY|||||||0.881|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84||||0.881
71727375|NCT03002818|142969016|SUPERIORITY|||||||0.775|||||||Paired Wilcoxon Test|||sdITT (n=23): Baseline vs. Day 84||||0.775
71727376|NCT00100230|142969029|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.3|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.30
71727377|NCT00100230|142969030|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.27
71727378|NCT00100230|142969030|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
71727379|NCT00100230|142969031|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||8e-06|TWO_SIDED|||||Threshold for significance: p\<0.05|Mixed Models Analysis|||||||0.000008
71771038|NCT01857310|143041584|SUPERIORITY||Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.33|0.11||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of good quality embryos will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.11|-0.33|
71771039|NCT01857310|143041585|SUPERIORITY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-6.66|4.05||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Proportion of good quality embryos on day 5 will be compared using generalized estimating equations accounting for multiple cycles per couple."||4.05|-6.66|
71771040|NCT01857310|143041586|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.11|0.1||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos transferred will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.10|-0.11|
71771041|NCT01857310|143041587|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.23|0.18||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of embryos cryopreserved will be compared using Poisson regression with generalized estimating equations accounting for multiple cycles per couple."||0.18|-0.23|
71771042|NCT01857310|143041588|SUPERIORITY||Mean Difference (Final Values)|-12.1|||||TWO_SIDED|95.0|-45.4|21.2||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Sperm penetration percentage will be compared using generalized estimating equations accounting for multiple cycles per couple."||21.2|-45.4|
71727380|NCT03392883|142969141|OTHER|Paired version (T-test for paired sample, Friedman and McNemar tests) was used for contrasting the equality among the variables at different moments of time. In order to adjust our results by potential confounders, ANCOVA analyses was performed. Symmetric 95% confidence intervals will be provided for relevant parameters. All p-values were referred to two-sided hypotheses. P-values below 0.05 were considered statistically significant.|||||<|0.001|TWO_SIDED|95.0||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale. This Statistical Analysis describes the Adoption subscale results.||||<0.001
71831055|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.50|0.0005
71831056|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.09||0.1273|TWO_SIDED|95.0|-0.33|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.33|0.1273
71831057|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.57|-0.2|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.20|-0.57|<0.0001
71831058|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6349|TWO_SIDED|95.0|-0.31|0.19|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.31|0.6349
71831059|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.13||0.1339|TWO_SIDED|95.0|-0.44|0.06|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.44|0.1339
71831060|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.6237|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6237
71888562|NCT00132041|143298084|OTHER||GEE|-0.9101||||0.0221|TWO_SIDED|95.0|-1.6894|-0.1308|||Generlaized Estimating Equations|multivariate GEE model using logistic link|Estimation parameter is for tumor size when controlling for other covariates.|Effect of tumor size in the multivariate model with response:18 mo success/failure; covariates: tumor size,repeated RFA, local tumor recurrence, remote tumor occurrence, and age and gender.||-0.1308|-1.6894|0.0221
71727381|NCT03392883|142969141|OTHER|||||||0.552||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Acceptability subscale results.||||0.552
71727382|NCT03392883|142969141|OTHER|||||||0.32||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Appropriateness subscale results.||||0.320
71727383|NCT03392883|142969141|OTHER|||||||0.879||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Feasibility subscale results.||||0.879
71727384|NCT03392883|142969141|OTHER|||||||0.242||||||p\<0.05 is the threshold for statistical significance.|t-test, 2 sided|||We analyzed changes over time for every subscale in this instrument. This Statistical Analysis describes the Reach/Access subscale results.||||0.242
71831061|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4224|TWO_SIDED|95.0|-0.37|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.37|0.4224
71831062|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7526|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7526
71888563|NCT00132041|143298086|OTHER||Mean Difference (Final Values)|-0.458|STANDARD_ERROR_OF_MEAN|0.2496||0.06|TWO_SIDED|||||assuming unequal variance (Satterthwaite p)|t-test, 2 sided||Difference represents the size of tumors that do no recur minus those that do.|the mean tumor size in the two groups, recurred and non recurred tumors, will be compared using a t-test assuming H0: recur=non-recurr||||0.06
71888564|NCT00132041|143298088|OTHER||Sensitivity|0.083|||||TWO_SIDED|95.0|0.0|0.38|||||Twelve tumors were detected in the liver specimens, but only one of those was identified by the CT central readers|||0.38|0.00|
71888565|NCT00132041|143298088|OTHER||Specificity|0.75|||||TWO_SIDED|95.0|0.194|0.994|||||The central CT readers correctly identified three out of the four patients without pathologic evidence of tumor|Specificity||0.994|0.194|
71727385|NCT03392883|142969142|OTHER|||||||0.237||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.237
71727386|NCT03392883|142969142|OTHER|||||||0.492||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.492
71727387|NCT03392883|142969142|OTHER|||||||0.285||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.285
71727388|NCT03392883|142969142|OTHER|||||||0.964||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.964
71727389|NCT03392883|142969142|OTHER|||||||0.942||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Resources subscale results.||||0.942
71727390|NCT03392883|142969142|OTHER|||||||0.366||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Scope subscale results.||||0.366
71727391|NCT03392883|142969142|OTHER|||||||0.021||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.021
71727392|NCT03392883|142969142|OTHER|||||||0.832||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.832
71727393|NCT03392883|142969142|OTHER|||||||0.827||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.827
71727394|NCT03392883|142969143|OTHER|||||||0.118||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.118
71727395|NCT03392883|142969143|OTHER|||||||0.896||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Accessibility subscale results.||||0.896
71727396|NCT03392883|142969143|OTHER|||||||0.739||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Appropriateness subscale results.||||0.739
71727397|NCT03392883|142969143|OTHER|||||||0.724||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Feasibility subscale results.||||0.724
71727398|NCT03392883|142969143|OTHER|||||||0.301||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Adoption subscale results.||||0.301
71727399|NCT03392883|142969143|OTHER|||||||0.034||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Organizational Climate subscale results.||||0.034
71888566|NCT00132041|143298090|OTHER|McNemar's Test to compare success rates after assuming transplants as successes versus after assuming transplants as failures.||||||0.0001|||||||McNemar|||||||0.0001
71727400|NCT03392883|142969143|OTHER|||||||0.015||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Leadership in Implementing subscale results.||||0.015
71727401|NCT03392883|142969143|OTHER|||||||0.081||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the General Leadership Skills subscale results.||||0.081
71727402|NCT03392883|142969143|OTHER|||||||0.79||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes over time in this data for every sub-scale. This Statistical Analysis describes the Knowledge subscale results.||||0.790
71727403|NCT03392883|142969144|OTHER|||||||0.023||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time.||||0.023
71727404|NCT03392883|142969145|OTHER|||||||0.589||||||p\<0.05 is the threshold for statistical significance.|Regression, Linear|||We analyzed changes in the overall scores over time in this data.||||0.589
71727405|NCT03392883|142969146|OTHER||Mean Difference (Net)|-6.65|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
71727406|NCT03392883|142969147|OTHER||Mean Difference (Net)|-4.48|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the total scores (sum of 12 items) at baseline assessment and at 12-month follow-up assessment.||||
71727407|NCT03392883|142969148|OTHER||Mean Difference (Net)|-5.77|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the scores at baseline assessment and at 12-month follow-up assessment.||||
71727408|NCT03392883|142969149|OTHER||Mean Difference (Net)|-2.59|||||TWO_SIDED|||||||||We analyzed changes over time by calculating the mean difference of the number of standard drinks per week at baseline assessment and at 12-month follow-up assessment.||||
71738998|NCT00620113|142990736|SUPERIORITY_OR_OTHER||Difference in LS Means|2.48||||0.598|TWO_SIDED|95.0|-7.79|12.74||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.74|-7.79|0.598
71888567|NCT02613208|143298124|OTHER|Correlation analysis|Spearman coefficient|0.392|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering baseline CTC count||||<0.001
71727409|NCT00132691|142969199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.03||0.16|TWO_SIDED|95.0|-1.16|6.68||unadjusted|Generalized estimating equations, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|"Null hypothesis: There will be no difference in change in visual acuity between treatment groups.~Assuming 67% bilateral disease, between eye correlation of 0.4, SD of 16 letters' change over 2 years and two-sided type 1 error rate of .05, a sample size of 250 provided 91% power (assuming 10% crossover) to detect a treatment difference of 7.5 standard ETDRS letters' change in visual acuity from baseline to 24 months."||6.68|-1.16|0.16
71727410|NCT00132691|142969200|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.61||||0.071|TWO_SIDED|95.0|0.34|1.03||unadjusted|GEE, logistic||For each treatment group the odds of macular edema at 2 yrs as compared to baseline was computed. The treatment effect is the ratio of these odds (implant divided by systemic).|||1.03|0.34|0.071
71727411|NCT00132691|142969201|SUPERIORITY_OR_OTHER||Ratio of odds ratios|0.29||||0.001|TWO_SIDED|95.0|0.13|0.6||unadjusted|GEE, logistic||For each treatment group the odds of uveitis activity at 2 years as compared to baseline was computed. The treatment effect represents the ratio of these odds (implant divided by systemic).|||.60|.13|0.001
71727412|NCT00132691|142969202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.15||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 30 mmHg or greater. The systemic arm was the reference group.|||11.15|3.32|<.0001
71727413|NCT00132691|142969203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.34|5.5||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 24 mmHg or greater. The systemic arm was the reference group|||5.50|2.34|<.0001
71727414|NCT00132691|142969204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.78|6.58||unadjusted|Cox proportional hazards with RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP that was 10mmHg or greater than the baseline value. The systemic arm was the reference group.|||6.58|2.78|<.0001
71727415|NCT00132691|142969205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.19||||0.0008|TWO_SIDED|95.0|1.82|9.63||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing glaucoma. The systemic arm was the reference group.|||9.63|1.82|0.0008
71727416|NCT00132691|142969206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.16|||<|0.0001|TWO_SIDED|95.0|2.67|6.47||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of using an IOP-lowering therapy. The systemic arm was the reference group.|||6.47|2.67|<.0001
71727417|NCT00132691|142969207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|8.4|||<|0.0001|TWO_SIDED|95.0|3.39|20.82||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of having surgery to lower IOP. The systemic arm was the reference group.|||20.82|3.39|<0.0001
71888568|NCT02613208|143298124|OTHER|Correlation analysis|Spearman coefficient|0.088||||0.444|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering CTC count at cycle 2||||0.444
71888569|NCT02613208|143298126|OTHER|Correlation analysis|Spearman coefficient|0.373|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering baseline CTC count||||<0.001
71888570|NCT02613208|143298126|OTHER|Correlation analysis|Spearman coefficient|0.129||||0.241|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering CTC count at cycle 2||||0.241
71888571|NCT02804763|143298141|SUPERIORITY||||||=|0.0727||||||The lowest p-value (z-statistic with the highest value) was used to establish proof of dose response.|MCP-Mod|||"Multiple contrast testing (MCP-mod methodology) was used to test for a statistically significant dose-response relationship between the primary endpoint (BICLA at Week 24) and dose, which would indicate a drug effect of DZP over Placebo.~The best fitting statistically significant model could be used to estimate the dose needed to achieve desired treatment effect."||||=0.0727
71888572|NCT02804763|143298142|SUPERIORITY||Odds Ratio (OR)|1.6|||=|0.2699|TWO_SIDED|95.0|0.7|3.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||3.8|0.7|=0.2699
71888573|NCT02804763|143298142|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.1036|TWO_SIDED|95.0|0.9|4.8||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.8|0.9|=0.1036
71888574|NCT02804763|143298142|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.1518|TWO_SIDED|95.0|0.8|4.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using a logit link function for the odds ratios and p-values.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||4.3|0.8|=0.1518
71727418|NCT00132691|142969208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12|||<|0.0001|TWO_SIDED|95.0|2.21|7.67||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing a cataract. The systemic arm was the reference group.|||7.67|2.21|<0.0001
71727419|NCT00132691|142969209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.64|STANDARD_ERROR_OF_MEAN|2.3||0.043|TWO_SIDED|95.0|0.14|9.15||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||9.15|0.14|0.043
71727420|NCT00132691|142969210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62|STANDARD_ERROR_OF_MEAN|1.6||0.023|TWO_SIDED|95.0|0.49|6.76||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic)|||6.76|0.49|0.023
71727421|NCT00132691|142969211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.95|STANDARD_ERROR_OF_MEAN|1.23||0.016|TWO_SIDED|95.0|0.54|5.36||unadjusted|Generalized Estimating Equations||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|||5.36|0.54|0.016
71727422|NCT00132691|142969212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.84|TWO_SIDED|95.0|0.39|2.15||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hyperlipidemia for the implant and systemic treatments. The systemic treatment is the reference group.|||2.15|0.39|0.84
71727423|NCT00132691|142969213|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.13|TWO_SIDED|95.0|0.13|1.29||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hypertension for the implant and systemic treatments. The systemic treatment is the reference group.|||1.29|0.13|0.13
71727424|NCT00132691|142969214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.24|TWO_SIDED|95.0|0.03|2.44||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of diabetes mellitus for the implant and systemic treatments. The systemic treatment is the reference group.|||2.44|0.03|0.24
71727425|NCT04098367|142969220|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.6|||||TWO_SIDED|97.5|13.34|46.79|||Miettinen-Nurminen||VIVITY minus SYMFONY|||46.79|13.34|
71727426|NCT04098367|142969220|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|30.1|||||TWO_SIDED|97.5|12.54|46.68|||Miettinen-Nurminen||VIVITY minus AT LARA|||46.68|12.54|
71727427|NCT04098367|142969221|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|-2.3|||||TWO_SIDED|97.5|-21.91|17.42|||Miettinen-Nurminen||VIVITY minus SYMFONY|||17.42|-21.91|
71727428|NCT04098367|142969221|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|8.2|||||TWO_SIDED|97.5|-12.0|27.8|||Miettinen-Nurminen||VIVITY minus AT LARA|||27.80|-12.00|
71727429|NCT04098367|142969222|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|23.5|||||TWO_SIDED|97.5|4.66|40.86|||Miettinen-Nurminen||VIVITY minus SYMFONY|||40.86|4.66|
71727430|NCT04098367|142969222|SUPERIORITY|Superiority is concluded if the lower limit of the two-sided 97.5% confidence interval exceeds zero.|Difference in percentage|40.7|||||TWO_SIDED|97.5|21.16|57.22|||Miettinen-Nurminen||VIVITY minus AT LARA|||57.22|21.16|
71727431|NCT01106859|142969249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.0174|TWO_SIDED|95.0|0.1|1.5||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups.||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) - LS mean of SDLP (Placebo).||1.5|0.1|0.0174
71727432|NCT01106859|142969249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.8|2.1||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) - LS mean of SDLP (Placebo).||2.1|0.8|<0.0001
71727433|NCT01106859|142969249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.8|3.1||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) - LS mean of SDLP (Placebo).||3.1|1.8|<0.0001
71727434|NCT01106859|142969250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.0145|TWO_SIDED|95.0|0.03|0.27||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) - LS mean of SDS (Placebo).||0.27|0.03|0.0145
71727435|NCT01106859|142969250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.2179|TWO_SIDED|95.0|-0.05|0.2||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) - LS mean of SDS (Placebo).||0.20|-0.05|0.2179
71727436|NCT01106859|142969250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.0096|TWO_SIDED|95.0|0.04|0.29||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) - LS mean of SDS (Placebo).||0.29|0.04|0.0096
71727437|NCT01106859|142969253|SUPERIORITY_OR_OTHER|||||||0.2188||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.2188
71727438|NCT01106859|142969253|SUPERIORITY_OR_OTHER|||||||0.0117||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0117
71727439|NCT01106859|142969253|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
71727440|NCT01106859|142969255|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.1250
71727441|NCT01106859|142969255|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0074
71727442|NCT01106859|142969255|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||<0.0001
71727443|NCT01106859|142969257|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.5000
71727444|NCT01106859|142969257|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0156
71771043|NCT01857310|143041589|SUPERIORITY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.16|0.03||||||"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared with Poisson regression using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||0.03|-0.16|
71727445|NCT01106859|142969257|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.||||0.0001
71727446|NCT03777709|142969263|SUPERIORITY||Mean Difference (Final Values)|1.45|STANDARD_DEVIATION|2.0|<|0.0001|TWO_SIDED|||||unadjusted p-value|Regression, Linear||A recruitment aim of 40 participants per church (16 churches, 8 per arm, mean of 5 participants per church) provides 80% power to detect a difference of 1.45 in mean LS7 score change between groups (effect size 0.73).|Effect size of 1-unit difference in mean LS7 score was based on meta-analysis indicating each unit increase in mean LS7 metrics equates to a 19% and 11% reduction in CVD and all-cause mortality, respectively. Power calculations to estimate sample size: church goal of 16 churches (8/arm), with mean 5 participants/church (40/arm) to provide 80% power to detect 1.45 difference in average LS7 score change between groups (.01 intracluster correlation, and .5 coefficient of variation of church sizes).||||<0.0001
71727447|NCT03575065|142969290|SUPERIORITY|||||||0.021||||||p-value was based on an exact binomial test with historic control ORR=0.25|Exact Binomial Test|||||||0.0210
71727448|NCT01528891|142969340|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Heart rate values at each time point were compared between groups.||||<0.01
71727449|NCT01528891|142969340|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
71727450|NCT01528891|142969340|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.||||<0.01
71727451|NCT01528891|142969341|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P\<0.0001 was calculated for both groups.|Fisher Exact|||The incidence of agitated patients in each group was compared.||||<0.0001
71727452|NCT01528891|142969342|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Systolic blood pressure values were compared between groups at each time point.||||<0.01
71727453|NCT01528891|142969342|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes.~P-values are adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline value within each group over time.||||<0.01
71727454|NCT01528891|142969342|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline within each group over time.||||<0.01
71727455|NCT01528891|142969343|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points: 1 minute and PACU.~P-values were adjusted for multiple comparisons."|t-test, 2 sided|||DBP values were compared between groups at each time point.||||<0.01
71727456|NCT01528891|142969343|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared within each group against the baseline value.||||<0.01
71727457|NCT01528891|142969343|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||"P\<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared against the baseline value within each group over time.||||<0.01
71727458|NCT00957944|142969447|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0302||||||90.0|0.9693|1.0951|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0951|0.9693|
71727459|NCT00957944|142969448|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0571||||||90.0|0.9903|1.1284|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.1284|0.9903|
71727460|NCT00957944|142969449|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0289||||||90.0|0.9714|1.0899|||ANOVA|ANOVA for log- transformed values has been used as the basis for calculation of point estimates (LS- Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0899|0.9714|
71727461|NCT03172884|142969462|OTHER||LS means|1.385|||||TWO_SIDED|90.0|0.921|2.081||||||Moderate Hepatic Impairment vs Healthy Subjects||2.081|0.921|
71727462|NCT03172884|142969462|OTHER||LS means|1.445|||||TWO_SIDED|90.0|0.998|2.093||||||Severe hepatic impairment group vs Healthy Subjects||2.093|0.998|
71727463|NCT03172884|142969462|OTHER||LS means|0.646|||||TWO_SIDED|90.0|0.486|0.858||||||Severe renal impairment group vs Healthy Subjects||0.858|0.486|
71727464|NCT03172884|142969463|OTHER||LS Means|1.711|||||TWO_SIDED|90.0|1.148|2.55||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.550|1.148|
71727465|NCT03172884|142969463|OTHER||LS Means|2.705|||||TWO_SIDED|90.0|2.115|3.46||||||Severe hepatic impairment group vs Healthy Subjects||3.460|2.115|
71727466|NCT03172884|142969463|OTHER||LS Means|1.075|||||TWO_SIDED|90.0|0.696|1.659||||||Severe renal impairment group vs Healthy Subjects||1.659|0.696|
71727467|NCT03172884|142969464|OTHER||LS Means|1.768|||||TWO_SIDED|90.0|1.251|2.498||||||Moderate Hepatic Impairment group vs Healthy Subjects||2.498|1.251|
71727468|NCT03172884|142969464|OTHER||LS Means|2.735|||||TWO_SIDED|90.0|2.163|3.459||||||Severe hepatic impairment group vs Healthy Subjects||3.459|2.163|
71727469|NCT03172884|142969464|OTHER||LS Means|1.124|||||TWO_SIDED|90.0|0.815|1.549||||||Severe renal impairment group vs Healthy Subjects||1.549|0.815|
71727470|NCT00522418|142969471|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||F Test|||||||.01
71727471|NCT00522418|142969474|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
71727472|NCT00522418|142969477|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||F-Test|||||||0.17
71727473|NCT00522418|142969478|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||F-Test|||||||0.28
71727474|NCT00522418|142969479|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||F-Test|||||||0.03
71727475|NCT00522418|142969480|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||F-Test|||||||0.26
71727476|NCT00737568|142969497|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.||||0.43
71727477|NCT00855933|142969510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.066||0.126|TWO_SIDED|95.0|-0.03|0.24||a priori threshold for statistical significance = 0.05|ANCOVA||2-sided with the significance level set at 5%|||0.24|-0.03|0.126
71727478|NCT01960998|142969512|SUPERIORITY|||||||0.22||||||P value not adjusted for multiple comparisons|Log Rank||||Data were not collected beyond the 12-month follow up, at which point fewer than 50% of participants in both groups had achieved continence. Thus, their time to continence could not be determined and the medians could not be calculated.|||0.22
71727479|NCT01960998|142969513|SUPERIORITY|||||||0.7||||||P values were not corrected for multiple testing|ANCOVA|Baseline score was included as a covariate in analysis.|||Mean values for the telehealth and no telehealth groups on the ICIQ-SF are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean ICIQ-SF score in the no telehealth group at 6 months was 7.0 (standard deviation 4.4) and in the telehealth group was 7.1 (SD 4.3). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline ICIQ-SF score, and p values were combined using the Rubin-Licht method.|||0.70
71727480|NCT01960998|142969514|SUPERIORITY|||||||0.7||||||P values were not adjusted for multiple comparisons.|ANCOVA||||Mean values for the telehealth and no telehealth groups on the EPIC-UI are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPIC-UI score in the no telehealth group at 6 months was 63.5 (standard deviation 24.1) and in the telehealth group was 63.9 (SD 22.1). Analysis of covariance (ANCOVA) was performed with each of the 10 imputations, adjusting for baseline EPIC-UI score, and p values were combined using the Rubin-Licht method.|||0.70
71727481|NCT01960998|142969515|SUPERIORITY|||||||0.46||||||P values not adjusted for multiple comparisons.|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the IIQ are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean IIQ score in the no telehealth group at 6 months was 22.3 (standard deviation 24.1) and in the telehealth group was 19.4 (SD 22.4). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.46
71727482|NCT01960998|142969516|SUPERIORITY|||||||0.63||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Quality of Life question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 31.4% (Delighted/Pleased), 22.8% (Mostly Satisfied), 19.4% (Mixed), 12.0% (Mostly Dissatisfied), and 14.4% (Unhappy/Terrible) and in the telehealth group were 20.8%, 26.3%, 26.3%, 12.6%, and 14.0%, respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the IPSS Quality of Life question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
71727483|NCT01960998|142969517|SUPERIORITY|||||||0.04||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Patient Satisfaction question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Completely Satisfied), 40.2% (Somewhat Satisfied), and 8.7% (Not at All Satisfied) and in the telehealth group were 34.8%, 59.9%, and 5.3%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Patient Satisfaction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.04
71727484|NCT01960998|142969518|SUPERIORITY|||||||0.67||||||P values not adjusted for multiple comparisons|t-test, 2 sided||||Mean values for the telehealth and no telehealth groups on the Estimated Percent Improvement (EPI) are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean EPI score in the no telehealth group at 6 months was 65.1 (standard deviation 34.5) and in the telehealth group was 69.6 (SD 29.6). Two-sample t-tests were performed with each of the 10 imputations, and p values were combined using the Rubin-Licht method.|||0.67
71727485|NCT01960998|142969519|SUPERIORITY|||||||0.65|||||||Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Global Perception of Improvement (GPI) question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 46.3% (Much Better), 30.7% (Better), 16.7% (About the Same), 2.3% (Worse), and 3.9% (Much Worse) and in the telehealth group were 38.3%, 41.1%, 15.3%, 2.9%, and 2.5%, respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 5 levels of the Global Perception of Improvement question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.65
71727486|NCT01960998|142969520|SUPERIORITY|||||||0.37||||||P values were not corrected for multiple comparisons|Chi-squared, Corrected||||"Frequencies for the telehealth and no telehealth groups on the How Disturbing is the Urine Leakage? question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 43.5% (Not at All), 44.4% (Somewhat), and 12.1% (Extremely) and in the telehealth group were 38.9%, 53.2%, and 7.9% respectively. Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the How Disturbing is the Urine Leakage? question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method."|||0.37
71727487|NCT01960998|142969521|SUPERIORITY|||||||0.63||||||P values were not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Activity Restriction question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 51.0% (Not at all), 36.5% (Some of the time), 7.2% (Most of the time), and 5.3% (All of the time) and in the telehealth group were 56.5%, 33.5%, 4.2%, and 5.8% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Activity Restriction question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.63
71771044|NCT01857310|143041590|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.88|1.61|||||Fewer than 4 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.61|0.88|
71771045|NCT01857310|143041591|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.77|1.43|||||Fewer than 8 cells|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Number of cells on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.43|0.77|
71771046|NCT01857310|143041592|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 3 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.87|
71771047|NCT01857310|143041593|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.63|1.06|||||Excellent or good morphology|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Embryo morphology on day 5 will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.06|0.63|
71771048|NCT01857310|143041594|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||ICSI|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Method of fertilization will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.09|0.80|
71888575|NCT02804763|143298142|SUPERIORITY||Difference vs PBO|11.6|||||TWO_SIDED|95.0|-9.2|32.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 1 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.4|-9.2|
71727488|NCT01960998|142969522|SUPERIORITY|||||||0.71||||||P values not adjusted for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Return to Work question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 52.3% (Yes), 5.0% (No, not yet recovered from surgery), 1.9% (No, other reason), and 40.7% (Retired or disabled) and in the telehealth group were 62.3%, 3.5%, 0.8%, and 33.5% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 4 levels of the Return to Work question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.71
71727489|NCT01960998|142969523|SUPERIORITY|||||||0.41||||||P values not corrected for multiple comparisons|Chi-squared, Corrected||||Frequencies for the telehealth and no telehealth groups on the Resumption of Normal Activities question relative to the expected frequencies question are presented above. Multiple imputation was performed to account for missing data, using the Multiple Imputation via Chained Equations (MICE) package in R. Across 10 imputations, the mean frequencies for the no telehealth group at 6 months were 7.4% (None), 29.8% (Some), 62.8% (All) and in the telehealth group were 4.9%, 23.0%, and 72.2% respectively (frequencies to not add to exactly 100% due to rounding). Chi-squared analysis with continuity correction was used to determine if there were differences in the observed frequencies between groups (telehealth versus no telehealth) across the 3 levels of the Resumption of Normal Activities question relative to the expected frequencies with each of the imputations, and p values were combined using the Enders (2001) method.|||0.41
71727490|NCT01686750|142969526|SUPERIORITY||Risk Ratio (RR)|1.31||||0.09|TWO_SIDED|95.0|0.95|1.81|||Prevalence ratio||Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.|We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.||1.81|0.95|0.09
71727491|NCT01686750|142969527|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.8|1.5||||||||1.50|0.80|
71727492|NCT01686750|142969528|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.81||||||||1.81|0.61|
71727493|NCT01686750|142969529|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.77|2.41||||||||2.41|0.77|
71727494|NCT01686750|142969531|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.28||||||||1.28|0.65|
71771049|NCT01857310|143041595|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Excellent or good quality|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Quality of embryos transferred will be compared using generalized estimating equations accounting for multiple embryos per cycle and multiple cycles per couple."||1.21|0.88|
71727495|NCT01686750|142969533|SUPERIORITY||Risk Ratio, log|1.44|||||TWO_SIDED|95.0|0.42|4.93||||||||4.93|0.42|
71727496|NCT01686750|142969534|SUPERIORITY||Risk Ratio, log|1.87|||||TWO_SIDED|95.0|0.49|7.16||||||||7.16|0.49|
71727497|NCT01686750|142969535|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.53|1.56||||||||1.56|0.53|
71727498|NCT01686750|142969536|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-4.2|4.2||||||||4.2|-4.2|
71727499|NCT01686750|142969538|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.47|1.52||||||||1.52|0.47|
71727500|NCT01686750|142969540|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.0|-0.6||||||||-0.6|-3.0|
71888576|NCT02804763|143298142|SUPERIORITY||Difference vs PBO|17.3|||||TWO_SIDED|95.0|-3.3|38.0||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 2 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.0|-3.3|
71727501|NCT01686750|142969541|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.64|1.36||||||||1.36|0.64|
71727502|NCT01939002|142969542|SUPERIORITY_OR_OTHER||||||<|0.0001||||||1-sample Chi-square test comparing to Null hypotheses at 25%.|Chi-squared|||||||<0.0001
71727503|NCT01939002|142969543|SUPERIORITY_OR_OTHER|||||||0.2037||||||Chi-square test between 2 treatment arms.|Chi-squared|||||||0.2037
71727504|NCT01939002|142969545|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.||||||1.00
71727505|NCT01939002|142969545|SUPERIORITY_OR_OTHER|||||||0.5078|||||||McNemar|||||||0.5078
71727506|NCT01939002|142969545|SUPERIORITY_OR_OTHER|||||||0.5811|||||||McNemar|||||||0.5811
71727507|NCT01939002|142969546|SUPERIORITY_OR_OTHER|||||||0.0525|||||||McNemar|||||||0.0525
71727508|NCT01939002|142969546|SUPERIORITY_OR_OTHER|||||||0.0654|||||||McNemar|||||||0.0654
71727509|NCT01939002|142969546|SUPERIORITY_OR_OTHER|||||||0.5488|||||||McNemar|||||||0.5488
71727510|NCT01939002|142969547|SUPERIORITY_OR_OTHER|||||||0.0945|||||||paired t-test within 1 arm|||||||0.0945
71727511|NCT01939002|142969547|SUPERIORITY_OR_OTHER|||||||0.8246|||||||paired t-test within 1 arm|||||||0.8246
71727512|NCT01939002|142969547|SUPERIORITY_OR_OTHER|||||||0.2533|||||||paired t-test within 1 arm|||||||0.2533
71727513|NCT01939002|142969547|SUPERIORITY_OR_OTHER|||||||0.1631|||||||2-sample t-test between 2 arms|||||||0.1631
71727514|NCT01939002|142969548|SUPERIORITY_OR_OTHER|||||||0.3189|||||||paired t-test within 1 arm|||||||0.3189
71727515|NCT01939002|142969548|SUPERIORITY_OR_OTHER|||||||0.3582|||||||paired t-test within 1 arm|||||||0.3582
71727516|NCT01939002|142969548|SUPERIORITY_OR_OTHER|||||||0.8484|||||||paired t-test within 1 arm|||||||0.8484
71727517|NCT01939002|142969548|SUPERIORITY_OR_OTHER|||||||0.1771|||||||2-sample t-test between 2 arms|||||||0.1771
71727518|NCT01939002|142969549|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
71727519|NCT01939002|142969549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
71727520|NCT01939002|142969549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
71727521|NCT01939002|142969549|SUPERIORITY_OR_OTHER|||||||0.3792|||||||2-sample t-test between 2 arms|||||||0.3792
71727522|NCT01939002|142969550|SUPERIORITY_OR_OTHER|||||||0.0019|||||||paired t-test within 1 arm|||||||0.0019
71727523|NCT01939002|142969550|SUPERIORITY_OR_OTHER|||||||0.0009|||||||paired t-test within 1 arm|||||||0.0009
71727524|NCT01939002|142969550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||||||<0.0001
71727525|NCT01939002|142969551|SUPERIORITY_OR_OTHER|||||||0.0105|||||||paired t-test within 1 arm|||||||0.0105
71727526|NCT01939002|142969551|SUPERIORITY_OR_OTHER|||||||0.0789|||||||paired t-test within 1 arm|||||||0.0789
71727527|NCT01939002|142969551|SUPERIORITY_OR_OTHER|||||||0.0027|||||||paired t-test within 1 arm|||||||0.0027
71727528|NCT01939002|142969551|SUPERIORITY_OR_OTHER|||||||0.838|||||||2-sample t-test between 2 arms|||||||0.8380
71727529|NCT01939002|142969552|SUPERIORITY_OR_OTHER|||||||0.1407|||||||paired t-test within 1 arm|||||||0.1407
71771050|NCT01857310|143041596|SUPERIORITY||Risk Ratio (RR)|2.35|||||TWO_SIDED|95.0|0.74|7.43|||||Abnormal|"The primary analysis plan is based on an intention-to-treat (ITT) approach comparing the two treatment arms based on the randomized assignment. The common null hypothesis states that the effect of folic acid/zinc on the outcomes is null compared to the placebo. Chromosomal complement will be compared using generalized estimating equations accounting for multiple cycles per couple."||7.43|0.74|
71727530|NCT01939002|142969552|SUPERIORITY_OR_OTHER|||||||0.7805|||||||paired t-test within 1 arm|||||||0.7805
71727531|NCT01939002|142969552|SUPERIORITY_OR_OTHER|||||||0.2186|||||||paired t-test within 1 arm|||||||0.2186
71727532|NCT01939002|142969552|SUPERIORITY_OR_OTHER|||||||0.4234|||||||2-sample t-test between 2 arms|||||||0.4234
71727533|NCT01939002|142969553|SUPERIORITY_OR_OTHER|||||||0.009|||||||paired t-test within 1 arm|||||||0.0090
71727534|NCT01939002|142969553|SUPERIORITY_OR_OTHER|||||||0.0075|||||||paired t-test within 1 arm|||||||0.0075
71727535|NCT01939002|142969553|SUPERIORITY_OR_OTHER|||||||0.0002|||||||paired t-test within 1 arm|||||||0.0002
71727536|NCT01939002|142969553|SUPERIORITY_OR_OTHER|||||||0.7497|||||||2-sample t-test between 2 arms|||||||0.7497
71727537|NCT01939002|142969554|SUPERIORITY_OR_OTHER|||||||0.0545|||||||paired t-test within 1 arm|||||||0.0545
71727538|NCT01939002|142969554|SUPERIORITY_OR_OTHER|||||||0.3377|||||||paired t-test within 1 arm|||||||0.3377
71727539|NCT01939002|142969554|SUPERIORITY_OR_OTHER|||||||0.0391|||||||paired t-test within 1 arm|||||||0.0391
71727540|NCT01939002|142969554|SUPERIORITY_OR_OTHER|||||||0.4861|||||||2-sample t-test between 2 arms|||||||0.4861
71727541|NCT01939002|142969555|SUPERIORITY_OR_OTHER|||||||0.0834|||||||Fisher Exact|||first 8 weeks||||0.0834
71727542|NCT01939002|142969555|SUPERIORITY_OR_OTHER|||||||0.0767|||||||Fisher Exact|||Weeks 0-2||||0.0767
71727543|NCT01939002|142969555|SUPERIORITY_OR_OTHER|||||||0.732|||||||Fisher Exact|||Weeks 3-4||||0.7320
71727544|NCT01939002|142969555|SUPERIORITY_OR_OTHER|||||||0.5008|||||||Fisher Exact|||Weeks 5-6||||0.5008
71727545|NCT01939002|142969555|SUPERIORITY_OR_OTHER|||||||0.6422|||||||Fisher Exact|||Weeks 7-8||||0.6422
71727546|NCT01939002|142969556|SUPERIORITY_OR_OTHER|||||||0.2123|||||||paired t-test within 1 arm|||change at Week 4||||0.2123
71727547|NCT01939002|142969556|SUPERIORITY_OR_OTHER|||||||0.5834|||||||paired t-test within 1 arm|||change at Week 12||||0.5834
71727548|NCT01939002|142969556|SUPERIORITY_OR_OTHER|||||||0.8723|||||||paired t-test within 1 arm|||change at Week 24||||0.8723
71727549|NCT01939002|142969556|SUPERIORITY_OR_OTHER|||||||0.4173|||||||paired t-test within 1 arm|||change at Week 36||||0.4173
71727550|NCT01939002|142969556|SUPERIORITY_OR_OTHER|||||||0.2267|||||||paired t-test within 1 arm|||change at Week 48||||0.2267
71727551|NCT01939002|142969556|SUPERIORITY_OR_OTHER|||||||0.0171|||||||paired t-test within 1 arm|||change at Early Term||||0.0171
71727552|NCT01939002|142969557|SUPERIORITY_OR_OTHER|||||||0.0001|||||||paired t-test within 1 arm|||change at Week 4||||0.0001
71727553|NCT01939002|142969557|SUPERIORITY_OR_OTHER|||||||0.0007|||||||paired t-test within 1 arm|||change at Week 12||||0.0007
71727554|NCT01939002|142969557|SUPERIORITY_OR_OTHER|||||||0.0365|||||||paired t-test within 1 arm|||change at Week 24||||0.0365
71727555|NCT01939002|142969557|SUPERIORITY_OR_OTHER|||||||0.0197|||||||paired t-test within 1 arm|||change at Week 36||||0.0197
71727556|NCT01939002|142969557|SUPERIORITY_OR_OTHER|||||||0.4031|||||||paired t-test within 1 arm|||change at Week 48||||0.4031
71727557|NCT01939002|142969557|SUPERIORITY_OR_OTHER|||||||0.006|||||||paired t-test within 1 arm|||change at Early Termination||||0.0060
71727558|NCT01939002|142969558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71727559|NCT01939002|142969558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
71727560|NCT01939002|142969558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
71727561|NCT01939002|142969558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
71727562|NCT01939002|142969558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
71727563|NCT01939002|142969558|SUPERIORITY_OR_OTHER|||||||0.1789|||||||paired t-test within 1 arm|||change at Early Termination||||0.1789
71727564|NCT01939002|142969558|SUPERIORITY_OR_OTHER|||||||0.2248||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.2248
71727565|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71727566|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12||||<0.0001
71727567|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24||||<0.0001
71727568|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36||||<0.0001
71727569|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48||||<0.0001
71727570|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Early Termination||||<0.0001
71727571|NCT01939002|142969559|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||<0.0001
71727572|NCT01939002|142969560|SUPERIORITY_OR_OTHER|||||||0.7012|||||||paired t-test within 1 arm|||change at Week 4||||0.7012
71727573|NCT01939002|142969560|SUPERIORITY_OR_OTHER|||||||0.0548|||||||paired t-test within 1 arm|||change at Week 4||||0.0548
71888577|NCT02804763|143298142|SUPERIORITY||Difference vs PBO|15.0|||||TWO_SIDED|95.0|-5.5|35.4||Crude difference in proportion responding and standard Wald asymptotic 95 % CI based on the normal approximation to the binomial distribution.|Chi-squared||Difference and 95 % Wald CI in proportion of responders for SOC + DZP dose 3 iv Q4W (FAS) versus SOC + Placebo iv Q4W (FAS).|Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.4|-5.5|
71727574|NCT01939002|142969560|SUPERIORITY_OR_OTHER|||||||0.0782|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0782
71727575|NCT01939002|142969561|SUPERIORITY_OR_OTHER|||||||0.0006|||||||paired t-test within 1 arm|||change at Week 4||||0.0006
71727576|NCT01939002|142969561|SUPERIORITY_OR_OTHER|||||||0.0792|||||||paired t-test within 1 arm|||change at Week 4||||0.0792
71727577|NCT01939002|142969561|SUPERIORITY_OR_OTHER|||||||0.0961|||||||2-sample t-test between 2 arms|||change at Week 4||||0.0961
71727578|NCT01939002|142969562|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71727579|NCT01939002|142969562|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71727580|NCT01939002|142969562|SUPERIORITY_OR_OTHER|||||||0.4973|||||||2-sample t-test between 2 arms|||change at Week 4||||0.4973
71727581|NCT01939002|142969563|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4||||<0.0001
71727582|NCT01939002|142969563|SUPERIORITY_OR_OTHER|||||||0.0464|||||||paired t-test within 1 arm|||change at Week 4||||0.0464
71727583|NCT01939002|142969563|SUPERIORITY_OR_OTHER|||||||0.1905|||||||2-sample t-test between 2 arms|||change at Week 4||||0.1905
71727584|NCT01939002|142969564|SUPERIORITY_OR_OTHER|||||||0.6569|||||||paired t-test within 1 arm|||change at Week 12||||0.6569
71727585|NCT01939002|142969564|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 24||||0.1584
71727586|NCT01939002|142969564|SUPERIORITY_OR_OTHER|||||||0.5106|||||||paired t-test within 1 arm|||change at Week 36||||0.5106
71727587|NCT01939002|142969564|SUPERIORITY_OR_OTHER|||||||0.5927|||||||paired t-test within 1 arm|||change at Week 48||||0.5927
71727588|NCT01939002|142969564|SUPERIORITY_OR_OTHER|||||||0.384|||||||paired t-test within 1 arm|||change at Early Termination||||0.3840
71727589|NCT01939002|142969564|SUPERIORITY_OR_OTHER|||||||0.4182||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.4182
71727590|NCT01939002|142969565|SUPERIORITY_OR_OTHER|||||||0.2588|||||||paired t-test within 1 arm|||change at Week 12||||0.2588
71727591|NCT01939002|142969565|SUPERIORITY_OR_OTHER|||||||0.1092|||||||paired t-test within 1 arm|||change at Week 24||||0.1092
71727592|NCT01939002|142969565|SUPERIORITY_OR_OTHER|||||||1|||||||paired t-test within 1 arm|||change at Week 36||||1.0000
71727593|NCT01939002|142969565|SUPERIORITY_OR_OTHER|||||||0.219|||||||paired t-test within 1 arm|||change at Week 48||||0.2190
71727594|NCT01939002|142969565|SUPERIORITY_OR_OTHER|||||||0.6402||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model|||||||0.6402
71727595|NCT01939002|142969566|SUPERIORITY_OR_OTHER|||||||0.4821|||||||paired t-test within 1 arm|||change at Week 12||||0.4821
71727596|NCT01939002|142969566|SUPERIORITY_OR_OTHER|||||||0.5298|||||||paired t-test within 1 arm|||change at Week 24||||0.5298
71727597|NCT01939002|142969566|SUPERIORITY_OR_OTHER|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 36||||0.1584
71727598|NCT01939002|142969566|SUPERIORITY_OR_OTHER|||||||0.2547|||||||paired t-test within 1 arm|||change at Week 48||||0.2547
71727599|NCT01939002|142969566|SUPERIORITY_OR_OTHER|||||||0.0824|||||||paired t-test within 1 arm|||change at Early Termination||||0.0824
71727600|NCT01939002|142969566|SUPERIORITY_OR_OTHER|||||||0.3148||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.3148
71727601|NCT01939002|142969567|SUPERIORITY_OR_OTHER|||||||0.6508|||||||paired t-test within 1 arm|||change at Week 12||||0.6508
71727602|NCT01939002|142969567|SUPERIORITY_OR_OTHER|||||||0.0315|||||||paired t-test within 1 arm|||change at Week 48||||0.0315
71727603|NCT01939002|142969567|SUPERIORITY_OR_OTHER|||||||0.119|||||||paired t-test within 1 arm|||change at Early Termination||||0.1190
71727604|NCT01939002|142969567|SUPERIORITY_OR_OTHER|||||||0.152||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model|||||||0.1520
71727605|NCT01939002|142969569|SUPERIORITY_OR_OTHER|||||||0.0049|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0049
71727606|NCT01939002|142969569|SUPERIORITY_OR_OTHER|||||||0.223|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.2230
71727607|NCT01939002|142969569|SUPERIORITY_OR_OTHER|||||||0.0031|||||||paired t-test within 1 arm|||Change from 4WRI to L4W||||0.0031
71727608|NCT01939002|142969569|SUPERIORITY_OR_OTHER|||||||0.1624|||||||2-sample t-test between 2 arms|||Change from 4WRI to L4W||||0.1624
71727609|NCT03998670|142969581|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.1|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The primary analysis was the treatment group difference (and 95% CI) in mean distance control at the 8-week outcome visit using an ANCOVA adjusted for baseline distance control. The planned convenience sample size of 64 was expected to provide outcome data for at least 60 participants (30 per group).||1.1|-0.5|
71727610|NCT03998670|142969582|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-17.0|32.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||32|-17|
71727611|NCT03998670|142969583|SUPERIORITY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-27.0|19.0|||||Difference between Prism minus Non-Prism group (positive difference indicates Prism group better than Non-Prism group).|||19|-27|
71727612|NCT03998670|142969585|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.7|0.7|||||Difference in mean control and 95% confidence interval (CI) are from ANCOVA model adjusting for corresponding baseline control score. Prism group minus Non-Prism group (positive difference indicates Prism group worse than Non-Prism group).|The secondary analysis was the treatment group difference (and 95% CI) in mean near control at the 8-week outcome visit using an ANCOVA adjusted for baseline near control.||0.7|-0.7|
71727613|NCT01263015|142969618|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.3||||0.003|TWO_SIDED|95.0|2.3|12.2||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||12.2|2.3|0.003
71727614|NCT01263015|142969620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \> -10%.|Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.2|13.1||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||13.1|1.2|0.016
71727615|NCT01263015|142969620|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was \>-10%.|Difference in percentage|8.3||||0.01|TWO_SIDED|95.0|1.9|14.6||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.|||14.6|1.9|0.010
71727616|NCT01263015|142969623|NON_INFERIORITY_OR_EQUIVALENCE|Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment\*visit interaction, BL HIV-1 RNA\*visit interaction and BL CD4 cell count\*visit interaction. No assumptions were made about the correlations between a par.'s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.||||||0.003||95.0||||P-value is for the test of superiority.|Repeated Measure Mixed Model|||||||0.003
71727617|NCT03571672|142969629|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.08|STANDARD_DEVIATION|5.98||0.868|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.868
71727618|NCT03571672|142969629|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.23|STANDARD_DEVIATION|5.445||0.606|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.606
71727619|NCT03571672|142969629|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.43|STANDARD_DEVIATION|4.212||0.224|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.224
71727620|NCT03571672|142969630|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|6.682||0.715|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.715
71888578|NCT02804763|143298142|SUPERIORITY||LS Mean Difference vs PBO|11.9|||||TWO_SIDED|95.0|-8.7|32.5||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||32.5|-8.7|
71831063|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.13||0.7328|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7328
71727621|NCT03571672|142969630|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.526||0.956|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.956
71727622|NCT03571672|142969630|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|4.584||0.771|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.771
71727623|NCT03571672|142969631|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.944|0.97||||||Inter-Reader Variability Echo Enhanced||0.970|0.944|
71727624|NCT03571672|142969631|OTHER||Intra-class Correlation Coefficient|0.95|||||TWO_SIDED|95.0|0.931|0.964||||||Inter-Reader Variability Echo Unenhanced||0.964|0.931|
71727625|NCT03571672|142969631|OTHER||Intra-class Correlation Coefficient|0.957|||||TWO_SIDED|95.0|0.941|0.969||||||Inter-Reader Variability Echo Enhanced||0.969|0.941|
71727626|NCT03571672|142969631|OTHER||Intra-class Correlation Coefficient|0.934|||||TWO_SIDED|95.0|0.909|0.952||||||Inter-Reader Variability Echo Unenhanced||0.952|0.909|
71727627|NCT03571672|142969631|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.946|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.946|
71727628|NCT03571672|142969631|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.913|0.954||||||Inter-Reader Variability Echo Unenhanced||0.954|0.913|
71727629|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.988|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Diastolic Echo Enhanced||0.992|0.984|
71727630|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.986|||||TWO_SIDED|95.0|0.981|0.99||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.990|0.981|
71727631|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.96|||||TWO_SIDED|95.0|0.945|0.971||||||Inter-reader Variability End Diastolic Echo Enhanced||0.971|0.945|
71727632|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.925|||||TWO_SIDED|95.0|0.897|0.945||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.945|0.897|
71727633|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-reader Variability End Diastolic Echo Enhanced||0.978|0.958|
71727634|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.909|||||TWO_SIDED|95.0|0.876|0.934||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.934|0.876|
71727635|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-reader Variability End Systolic Echo Enhanced||0.992|0.984|
71727636|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.979|0.989||||||Inter-reader Variability End Systolic Echo Unenhanced||0.989|0.979|
71727637|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-reader Variability End Systolic Echo Enhanced||0.980|0.962|
71727638|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.927|0.961||||||Inter-reader Variability End Systolic Echo Unenhanced||0.961|0.927|
71727639|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-reader Variability End Systolic Echo Enhanced||0.984|0.969|
71727640|NCT03571672|142969632|OTHER||Intra-class Correlation Coefficient|0.937|||||TWO_SIDED|95.0|0.914|0.954||||||Inter-reader Variability End Systolic Echo Unenhanced||0.954|0.914|
71727641|NCT03571672|142969633|OTHER||Intra-class Correlation Coefficient|0.945|||||TWO_SIDED|95.0|0.909|0.967||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.967|0.909|
71727642|NCT03571672|142969633|OTHER||Intra-class Correlation Coefficient|0.917|||||TWO_SIDED|95.0|0.864|0.95||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.950|0.864|
71727643|NCT03571672|142969633|OTHER||Intra-class Correlation Coefficient|0.939|||||TWO_SIDED|95.0|0.9|0.963||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.963|0.900|
71727644|NCT03571672|142969633|OTHER||Intra-class Correlation Coefficient|0.894|||||TWO_SIDED|95.0|0.827|0.935||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.935|0.827|
71727645|NCT03571672|142969633|OTHER||Intra-class Correlation Coefficient|0.952|||||TWO_SIDED|95.0|0.92|0.971||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.971|0.920|
71727646|NCT03571672|142969633|OTHER||Intra-class Correlation Coefficient|0.9|||||TWO_SIDED|95.0|0.838|0.939||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.939|0.838|
71727647|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.961|0.986||||||Inter-reader Variability End Diastolic Echo Enhanced||0.986|0.961|
71727648|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.974|0.991||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.991|0.974|
71727649|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.933|||||TWO_SIDED|95.0|0.89|0.96||||||Inter-reader Variability End Diastolic Echo Enhanced||0.960|0.890|
71727650|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.857|||||TWO_SIDED|95.0|0.77|0.912||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.912|0.770|
71727651|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.914|0.969||||||Inter-reader Variability End Diastolic Echo Enhanced||0.969|0.914|
71727652|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.824|||||TWO_SIDED|95.0|0.721|0.892||||||Inter-reader Variability End Diastolic Echo Unenhanced||0.892|0.721|
71727653|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.982|||||TWO_SIDED|95.0|0.97|0.989||||||Inter-reader Variability End Systolic Echo Enhanced||0.989|0.970|
71727654|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.974|||||TWO_SIDED|95.0|0.957|0.985||||||Inter-reader Variability End Systolic Echo Unenhanced||0.985|0.957|
71727655|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.915|0.969||||||Inter-reader Variability End Systolic Echo Enhanced||0.969|0.915|
71727656|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.89|||||TWO_SIDED|95.0|0.822|0.933||||||Inter-reader Variability End Systolic Echo Unenhanced||0.933|0.822|
71727657|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.959|||||TWO_SIDED|95.0|0.932|0.975||||||Inter-reader Variability End Systolic Echo Enhanced||0.975|0.932|
71727658|NCT03571672|142969634|OTHER||Intra-class Correlation Coefficient|0.872|||||TWO_SIDED|95.0|0.794|0.922||||||Inter-reader Variability End Systolic Echo Unenhanced||0.922|0.794|
71727659|NCT00303446|142969635|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Generalized estimating equation model|The analysis includes percent change from baseline at 12 and 24 months.||||||0.28
71727660|NCT00303446|142969636|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.86
71727661|NCT00303446|142969637|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||Comparison of changes from baseline in manual muscle testing results.||||0.47
71727662|NCT00303446|142969638|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.13
71727663|NCT00303446|142969639|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.46
71727664|NCT00303446|142969640|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.11
71727665|NCT00303446|142969641|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.08
71727666|NCT00303446|142969642|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.73
71727667|NCT00303446|142969643|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.37
71727668|NCT00303446|142969644|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.65
71727669|NCT00303446|142969645|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.99
71727670|NCT00303446|142969646|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||1.0
71727671|NCT00303446|142969647|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.014
71727672|NCT00303446|142969648|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.|t-test, 2 sided|||||||0.033
71727673|NCT00303446|142969649|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||||||0.61
71727674|NCT05858450|142969653|OTHER||Weighted Hazard Ratio|1.108|||||TWO_SIDED|95.0|1.018|1.205||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an inverse probability of treatment weights (IPTW) was applied. Analysis performed using IPTW method.||1.205|1.018|
71727675|NCT05858450|142969653|OTHER||Weighted Hazard Ratio|0.634|||||TWO_SIDED|95.0|0.606|0.664||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.664|0.606|
71727676|NCT05858450|142969654|OTHER||Weighted Hazard Ratio|1.061|||||TWO_SIDED|95.0|1.016|1.107||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.107|1.016|
71727677|NCT05858450|142969654|OTHER||Weighted Hazard Ratio|0.897|||||TWO_SIDED|95.0|0.875|0.919||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.919|0.875|
71727678|NCT05858450|142969655|OTHER||Weighted Hazard Ratio|1.543|||||TWO_SIDED|95.0|1.133|2.1||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.1|1.133|
71727679|NCT05858450|142969655|OTHER||Weighted Hazard Ratio|1.106|||||TWO_SIDED|95.0|1.014|1.206||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.206|1.014|
71727680|NCT05858450|142969656|OTHER||Weighted Hazard Ratio|1.048|||||TWO_SIDED|95.0|0.903|1.217||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.217|0.903|
71727681|NCT05858450|142969656|OTHER||Weighted Hazard Ratio|0.908|||||TWO_SIDED|95.0|0.846|0.973||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.973|0.846|
71727682|NCT05858450|142969657|OTHER||Weighted Hazard Ratio|1.137|||||TWO_SIDED|95.0|1.068|1.211||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.211|1.068|
71727683|NCT05858450|142969657|OTHER||Weighted Hazard Ratio|1.057|||||TWO_SIDED|95.0|1.007|1.11||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.11|1.007|
71727684|NCT05858450|142969658|OTHER||Weighted Hazard Ratio|0.761|||||TWO_SIDED|95.0|0.718|0.807||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.807|0.718|
71727685|NCT05858450|142969658|OTHER||Weighted Hazard Ratio|0.858|||||TWO_SIDED|95.0|0.811|0.907||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.907|0.811|
71727686|NCT05858450|142969659|OTHER||Weighted Hazard Ratio|1.55|||||TWO_SIDED|95.0|0.88|2.731||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.731|0.88|
71727687|NCT05858450|142969659|OTHER||Weighted Hazard Ratio|1.035|||||TWO_SIDED|95.0|0.865|1.238||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.238|0.865|
71727688|NCT05858450|142969660|OTHER||Weighted Hazard Ratio|0.921|||||TWO_SIDED|95.0|0.687|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|0.687|
71727689|NCT05858450|142969660|OTHER||Weighted Hazard Ratio|0.826|||||TWO_SIDED|95.0|0.722|0.945||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||0.945|0.722|
71727690|NCT05858450|142969661|OTHER||Weighted Hazard Ratio|1.569|||||TWO_SIDED|95.0|1.088|2.264||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||2.264|1.088|
71727691|NCT05858450|142969661|OTHER||Weighted Hazard Ratio|1.118|||||TWO_SIDED|95.0|1.015|1.233||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.233|1.015|
71727692|NCT05858450|142969662|OTHER||Weighted Hazard Ratio|1.082|||||TWO_SIDED|95.0|0.911|1.286||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.286|0.911|
71727693|NCT05858450|142969662|OTHER||Weighted Hazard Ratio|0.932|||||TWO_SIDED|95.0|0.859|1.01||||||To account for imbalance in participant characteristics between the vaccine exposure groups, an IPTW was applied. Analysis performed using IPTW method.||1.01|0.859|
71831064|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5888|TWO_SIDED|95.0|-0.33|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.33|0.5888
71831065|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9345|TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.26|-0.28|0.9345
71888579|NCT02804763|143298142|SUPERIORITY||LS Mean Difference vs PBO|17.6|||||TWO_SIDED|95.0|-3.2|38.3||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||38.3|-3.2|
71888580|NCT02804763|143298142|SUPERIORITY||LS Mean Difference vs PBO|15.2|||||TWO_SIDED|95.0|-5.2|35.6||Generalized linear models with factors for treatment and corticosteroid strata were fit using an identity link function for the LS mean differences.|Chi-squared|||Missing values were imputed using modified non-responder imputation (mNRI) dataset: at most 1 missing BICLA (mNRI) component (scale) may have been carried forward from the immediately preceding visit, and missing data in the individual items within scales may have been carried forward from the immediately preceding visit. If there was still missing data after this limited imputation, the study participant was counted as a non-responder on the BICLA (mNRI) for that visit.||35.6|-5.2|
71727694|NCT00642174|142969668|SUPERIORITY_OR_OTHER||Least Squares Mean Difference (Net)|61.6|||<|0.0001||95.0|53.83|69.31||P-value is for 4 Hours After Loading Dose.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (i.e. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there is no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 4 hours after administration of loading dose. Assuming 90% power, 2-sided alpha of 0.05, and a 17.5% difference in IPA between treatment groups with a standard deviation of 20, a total of 15 completed subjects per sequence group (i.e., 15 subject who receive prasugrel first, then clopidogrel; and 15 subjects who receive clopidogrel first, then prasugrel) was determined.||69.31|53.83|<0.0001
71727695|NCT00642174|142969669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.5|||<|0.0001||95.0|27.43|45.52||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 1 hour after administration of the loading dose.||45.52|27.43|<0.0001
71727696|NCT00642174|142969669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.9|||<|0.0001||95.0|49.56|66.19||P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours after administration of the loading dose.||66.19|49.56|<0.0001
71727697|NCT00642174|142969669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.7|||<|0.0001||95.0|10.27|25.04||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours post-Last Maintenance Dose (LMD).||25.04|10.27|<0.0001
71727698|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.5466||95.0|-3.66|1.97||P-value for Baseline (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||1.97|-3.66|0.5466
71727699|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.0|||<|0.0001||95.0|-28.45|-17.55||P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.55|-28.45|<0.0001
71727700|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.6|||<|0.0001||95.0|-31.18|-22.02||P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-22.02|-31.18|<0.0001
71888581|NCT02522767|143298274|SUPERIORITY||Odds Ratio (OR)|1.55|||>|0.05|TWO_SIDED|95.0|0.73|3.32||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups, at a two-sided 0.05 significance level.||3.32|0.73|>0.05
71888582|NCT02522767|143298277|SUPERIORITY||Odds Ratio (OR)|1.78|||>|0.05|TWO_SIDED|95.0|0.96|3.29||The p-value was based on chi-square test without a continuity correction.|Chi-squared|||Proportions were compared between treatment groups at a two-sided 0.05 significance level.||3.29|0.96|>0.05
71888583|NCT02522767|143298278|SUPERIORITY||Odds Ratio (OR)|1.3|||>|0.05|TWO_SIDED|95.0|0.78|2.15|||Generalized estimating equation approach|||Proportions were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||2.15|0.78|>0.05
71727701|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|||<|0.0001||95.0|-27.42|-19.17||P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-19.17|-27.42|<0.0001
71727702|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0001||95.0|-12.78|-4.58||P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-4.58|-12.78|0.0001
71727703|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.8779||95.0|-2.8|3.26||P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||3.26|-2.80|0.8779
71727704|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.2|||<|0.0001||95.0|-32.43|-17.87||P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-17.87|-32.43|<0.0001
71727705|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.1|||<|0.0001||95.0|-40.32|-29.78||P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-29.78|-40.32|<0.0001
71727706|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|||<|0.0001||95.0|-36.32|-25.66||P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-25.66|-36.32|<0.0001
71727707|NCT00642174|142969670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.4|||<|0.0001||95.0|-17.19|-7.58||P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).||-7.58|-17.19|<0.0001
71727708|NCT00642174|142969671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.3692||95.0|-3.6|9.44||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||9.44|-3.60|0.3692
71727709|NCT00642174|142969671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.2|||<|0.0001||95.0|-47.43|-24.98||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-24.98|-47.43|<0.0001
71727710|NCT00642174|142969671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-53.0|||<|0.0001||95.0|-61.89|-44.02||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-44.02|-61.89|<0.0001
71888584|NCT02522767|143298279|SUPERIORITY||Hazard Ratio (HR)|1.36|||>|0.05|TWO_SIDED|95.0|0.91|2.02||The p-value was based on log-rank test.|Log Rank||Hazard ratio and its 95% CI were obtained from Cox proportional hazards model with treatment group as a factor.|Times to normal stool pattern were compared between treatment groups, at a two-sided 0.05 significance level.||2.02|0.91|>0.05
71888585|NCT02522767|143298280|SUPERIORITY||Treatment difference|-0.24|||<|0.05|TWO_SIDED|95.0|-0.41|-0.08|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||-0.08|-0.41|<0.05
71727711|NCT00642174|142969671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-42.8|||<|0.0001||95.0|-50.03|-35.55||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-35.55|-50.03|<0.0001
71727712|NCT00642174|142969671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9||||0.0012||95.0|-23.42|-6.37||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.||-6.37|-23.42|0.0012
71727713|NCT00642174|142969672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.5238||95.0|-5.35|2.78||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||2.78|-5.35|0.5238
71727714|NCT00642174|142969672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.2|||<|0.0001||95.0|-21.15|-11.33||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-11.33|-21.15|<0.0001
71727715|NCT00642174|142969672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9|||<|0.0001||95.0|-29.67|-18.11||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-18.11|-29.67|<0.0001
71727716|NCT00642174|142969672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.9|||<|0.0001||95.0|-24.97|-14.9||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||-14.90|-24.97|<0.0001
71727717|NCT00642174|142969672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.3725||95.0|-8.46|3.26||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).||3.26|-8.46|0.3725
71727718|NCT00896363|142969673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85|||||TWO_SIDED|90.0|-1.62|3.32|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 14||3.32|-1.62|
71771051|NCT00930982|143041613|SUPERIORITY_OR_OTHER||Difference in Least square means|-2.368|STANDARD_ERROR_OF_MEAN|2.674|<|0.001||||||p-value should be \< 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.|ANCOVA|Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.|Least square mean Ciprofloxacin minus placebo|"Ho: CFU(EOT\|Cipro) - CFU(baseline\|Cipro) \> CFU(EOT\|Placebo) - CFU(baseline\|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g"||||< 0.001
71771052|NCT03160859|143041671|SUPERIORITY|||||||0.62|||||||Chi-squared|||Chi Square||||0.62
71771053|NCT02522871|143041705|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.132|||<|0.0001|ONE_SIDED|95.0||-0.049|||one-sided Farrington and Manning|||||-0.049||<0.0001
71771054|NCT02522871|143041705|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.145|||<|0.0001|ONE_SIDED|95.0||-0.062|||one-sided Farrington and Manning|||||-0.062||<0.0001
71771055|NCT02522871|143041706|NON_INFERIORITY|non-inferiority margin of 1.0|Mean Difference (Final Values)|-0.03|||<|0.0001|TWO_SIDED|95.0|-0.084|0.025|||t-test, 1 sided|||||0.025|-0.084|<0.0001
71771056|NCT02522871|143041707|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
71771057|NCT02522871|143041707|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|0.0||||0.0004|ONE_SIDED|95.0||0.036|||one-sided Farrington and Manning|||||0.036||0.0004
71771058|NCT02522871|143041708|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
71888586|NCT02522767|143298281|SUPERIORITY||Treatment difference|-2.39|||>|0.05|TWO_SIDED|95.0|-5.46|0.67|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimate.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||0.67|-5.46|>0.05
71888587|NCT02522767|143298282|SUPERIORITY||Treatment difference|-289.69|||<|0.05|TWO_SIDED|95.0|-514.96|-64.42|||ANCOVA||An ANCOVA model was used to calculate estimates.|Changes from baseline were compared between treatment groups, at a two-sided 0.05 significance level.||-64.42|-514.96|<0.05
71727719|NCT00896363|142969673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||||TWO_SIDED|90.0|-2.12|2.78|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 14||2.78|-2.12|
71831066|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8782|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8782
71888588|NCT02522767|143298283|SUPERIORITY||Treatment difference|12.8|||<|0.05|TWO_SIDED|95.0|5.1|20.5|||Repeated-measures ANCOVA||A repeated-measures ANCOVA model with an unstructured correlation matrix was used to calculate estimates.|Change from baseline scores were compared between treatment groups over 8 weeks, at a two-sided 0.05 significance level.||20.50|5.10|<0.05
71888589|NCT02908100|143298302|SUPERIORITY||Absolute Difference|6.4||||0.373|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.373
71888590|NCT02908100|143298302|SUPERIORITY||Absolute Difference|7.5||||0.339|TWO_SIDED|95.0|-7.3|22.4|||Cochran-Mantel-Haenszel|||||22.4|-7.3|0.339
71727720|NCT00896363|142969673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|||||TWO_SIDED|90.0|-2.01|5.14|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 42||5.14|-2.01|
71727721|NCT00896363|142969673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|||||TWO_SIDED|90.0|-1.81|5.13|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 42||5.13|-1.81|
71727722|NCT00896363|142969674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31|||||TWO_SIDED|90.0|-0.93|1.56|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 14||1.56|-0.93|
71727723|NCT00896363|142969674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|||||TWO_SIDED|90.0|-0.73|1.75|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.75|-0.73|
71771059|NCT02522871|143041708|NON_INFERIORITY|non-inferiority margin = 0.075|Difference of Proportion|-0.001||||0.0006|ONE_SIDED|95.0||0.038|||one-sided Farrington and Manning|||||0.038||0.0006
71771060|NCT00219544|143041726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.25||0.0018||95.0|-1.27|-0.3|||ANCOVA||Difference = pregabalin minus placebo|The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level.||-0.30|-1.27|0.0018
71658461|NCT01000493|142832079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.64||||0.3702|TWO_SIDED|95.0|-14.9|5.62||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.62|-14.9|0.3702
71727724|NCT00896363|142969674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|||||TWO_SIDED|90.0|-1.1|2.42|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.42|-1.10|
71727725|NCT00896363|142969674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||||TWO_SIDED|90.0|-0.93|2.48|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.48|-0.93|
71727726|NCT00896363|142969675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|||||TWO_SIDED|90.0|-0.94|2.37|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 14||2.37|-0.94|
71727727|NCT00896363|142969675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44|||||TWO_SIDED|90.0|-2.1|1.21|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 14||1.21|-2.10|
71727728|NCT00896363|142969675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84|||||TWO_SIDED|90.0|-1.22|2.9|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 42||2.90|-1.22|
71771061|NCT00219544|143041729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.22||0.001||95.0|-1.15|-0.3|||ANCOVA||pregabalin minus placebo|Week 5||-0.30|-1.15|0.0010
71888591|NCT02908100|143298303|SUPERIORITY||Absolute Difference|8.7||||0.223|TWO_SIDED|95.0|-6.1|23.5|||Cochran-Mantel-Haenszel|||||23.5|-6.1|0.223
71727729|NCT00896363|142969675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81|||||TWO_SIDED|90.0|-1.22|2.85|||Mixed model repeated measures analysis||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 42||2.85|-1.22|
71727730|NCT00378599|142969727|SUPERIORITY_OR_OTHER||Binomial Approximation|0.288|||||TWO_SIDED|95.0|0.21|0.38||||||||0.38|0.21|
71888592|NCT02908100|143298303|SUPERIORITY||Absolute Difference|3.0||||0.737|TWO_SIDED|95.0|-11.8|17.7|||Cochran-Mantel-Haenszel|||||17.7|-11.8|0.737
71888593|NCT02908100|143298304|SUPERIORITY||Absolute Difference|4.1||||0.614|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.614
71888594|NCT02908100|143298304|SUPERIORITY||Absolute Difference|4.1||||0.607|TWO_SIDED|95.0|-10.7|18.9|||Cochran-Mantel-Haenszel|||||18.9|-10.7|0.607
71888595|NCT02908100|143298305|SUPERIORITY||Absolute Difference|6.4||||0.41|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.410
71888596|NCT02908100|143298305|SUPERIORITY||Absolute Difference|6.4||||0.418|TWO_SIDED|95.0|-8.5|21.2|||Cochran-Mantel-Haenszel|||||21.2|-8.5|0.418
71727731|NCT01691885|142969845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|||<|0.001|TWO_SIDED|95.0|2.74|8.91|||ANCOVA|Analysis was performed using an ANCOVA model with covariates of treatment, baseline, period and subject as a random effect.||||8.91|2.74|<0.001
71727732|NCT03989427|142969855|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|1.424||||0.022|TWO_SIDED|95.0|0.221|2.628||The threshold for statistical significance was p \<0.05|ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on BPI scores .||"Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation.~No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores."||2.628|0.221|0.022
71727733|NCT03989427|142969856|EQUIVALENCE|The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p \< 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically.|Mean Difference (Net)|-0.058||||0.971|TWO_SIDED|95.0|-3.335|3.219|||ANOVA|Three-way mixed ANOVA was done to determine the effect of Intervention on RMNPI index scores||"Null hypothesis:~The sequence of brushing and flossing has no effect on plaque scores~There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores."||3.219|-3.335|0.971
71727734|NCT03344549|142969879|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.37|TWO_SIDED|95.0||||The threshoid for statistical significance was p \<0.05|t-test, 2 sided|||U Mann Whitney was used for inter-group comparison||||0.37
71727735|NCT03344549|142969880|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0||||The threshold for statistical significance was p\<0.05|t-test, 2 sided|U Mann Whitney was used for inter-group comparison||||||0.46
71727736|NCT03344549|142969881|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71727737|NCT00108303|142969907|SUPERIORITY_OR_OTHER||Log (odd ratio)|5.2|||||TWO_SIDED|||||||||||||
71727738|NCT00108303|142969907|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||This parameter was estimated by simulating 1000 samples with random genotypes and finding no value equal to or greater than 5.2.|Simulation|||||||<0.001
71727739|NCT00108303|142969908|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Firsher's transform r to Z|||The coefficient of segregation versus no segregation of the P50 sensory gating percent in families with schizophrenia.||||0.001
71771062|NCT00219544|143041729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.41|-0.53|||ANCOVA||pregabalin minus placebo|Week 6||-0.53|-1.41|<.0001
71888597|NCT02908100|143298306|SUPERIORITY||Absolute Difference|14.9||||0.378|TWO_SIDED|95.0|-14.0|43.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||43.7|-14|0.378
71727740|NCT02075047|142969916|SUPERIORITY||Difference in least square (LS) mean|-4.23|STANDARD_ERROR_OF_MEAN|1.47||0.005|TWO_SIDED|95.0|-7.14|-1.32|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.32|-7.14|0.005
71727741|NCT02075047|142969917|SUPERIORITY||Difference in LS mean|-0.45|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.69|-0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.20|-0.69|<0.001
71727742|NCT02075047|142969917|SUPERIORITY||Difference in LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.174|TWO_SIDED|95.0|-0.53|0.1|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.10|-0.53|0.174
71727743|NCT02075047|142969917|SUPERIORITY||Difference in LS mean|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.71|-0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-0.05|-0.71|0.024
71727744|NCT02075047|142969917|SUPERIORITY||Difference in LS mean|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.138|TWO_SIDED|95.0|-0.64|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.64|0.138
71727745|NCT02075047|142969918|SUPERIORITY||Difference in LS mean|-5.85|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|TWO_SIDED|95.0|-8.16|-3.54|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.54|-8.16|<0.001
71727746|NCT02075047|142969918|SUPERIORITY||Difference in LS mean|-4.17|STANDARD_ERROR_OF_MEAN|1.3||0.002|TWO_SIDED|95.0|-6.74|-1.59|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-1.59|-6.74|0.002
71771063|NCT00219544|143041729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 7||-0.47|-1.39|<.0001
71888598|NCT02908100|143298306|SUPERIORITY||Absolute Difference|7.5||||0.732|TWO_SIDED|95.0|-21.7|36.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||36.7|-21.7|0.732
71727747|NCT02075047|142969918|SUPERIORITY||Difference in LS mean|-5.63|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|-8.21|-3.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||-3.04|-8.21|<0.001
71727748|NCT02075047|142969919|SUPERIORITY||Difference in LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|95.0|-0.78|-0.26|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.26|-0.78|0.001
71727749|NCT02075047|142969919|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.349|TWO_SIDED|95.0|-0.45|0.16|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.16|-0.45|0.349
71727750|NCT02075047|142969919|SUPERIORITY||Difference in LS mean|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.103|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||0.05|-0.57|0.103
71771064|NCT00219544|143041729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.93|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 8||-0.47|-1.39|<.0001
71771065|NCT00219544|143041729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|0.23||0.0022||95.0|-1.14|-0.25|||ANCOVA||pregabalin minus placebo|Week 9||-0.25|-1.14|0.0022
71771066|NCT00219544|143041735|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0031||95.0|-1.18|-0.24|||ANCOVA|||||-0.24|-1.18|0.0031
71771067|NCT00219544|143041738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.22||0.0177||95.0|-0.94|-0.09|||ANCOVA||pregabalin minus placebo|Week 5||-0.09|-0.94|0.0177
71771068|NCT00219544|143041738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.31|-0.44|||ANCOVA||pregabalin minus placebo|Week 6||-0.44|-1.31|<.0001
71771069|NCT00219544|143041738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0005||95.0|-1.28|-0.36|||ANCOVA||pregabalin minus placebo|Week 7||-0.36|-1.28|0.0005
71771070|NCT00219544|143041738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.23||0.0003||95.0|-1.31|-0.39|||ANCOVA||pregabalin minus placebo|Week 8||-0.39|-1.31|0.0003
71888599|NCT02908100|143298306|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
71727751|NCT02075047|142969919|SUPERIORITY||Difference in LS mean|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.044|TWO_SIDED|95.0|-0.68|-0.01|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects along with participant as a random effect.||-0.01|-0.68|0.044
71727752|NCT02075047|142969933|SUPERIORITY||Difference in LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED|95.0|0.0|0.2|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|0.00|0.050
71771071|NCT00219544|143041738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.22||0.0011||95.0|-1.18|-0.3|||ANCOVA||pregabalin minus placebo|Week 9||-0.30|-1.18|0.0011
71771072|NCT00219544|143041739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.0|STANDARD_ERROR_OF_MEAN|3.3||0.0069||95.0|-15.5|-2.5|||ANCOVA|||||-2.5|-15.5|0.0069
71771073|NCT00219544|143041740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0023||95.0|-2.1|-0.5|||ANCOVA||pregabalin minus placebo|HADS-A||-0.5|-2.1|0.0023
71771074|NCT00219544|143041740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0013||95.0|-1.9|-0.5|||ANCOVA||pregabalin minus placebo|HADS-D||-0.5|-1.9|0.0013
71771075|NCT00219544|143041741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.98|STANDARD_ERROR_OF_MEAN|3.42||0.0828||95.0|-0.79|12.75|||ANCOVA||pregabalin minus placebo|Impact||12.75|-0.79|0.0828
71771076|NCT00219544|143041741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.49|STANDARD_ERROR_OF_MEAN|2.75||0.0197||95.0|1.05|11.94|||ANCOVA||pregabalin minus placebo|Satisfaction||11.94|1.05|0.0197
71771077|NCT00219544|143041742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278||95.0|||||Mantel Haenszel|||The distribution of the responses to the PGIC at EOT was compared between the 2 treatment groups using the 7 categories of the PGIC.||||0.0278
71771078|NCT00219544|143041743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.76|STANDARD_ERROR_OF_MEAN|0.26||0.0049||95.0|-1.28|-0.23|||ANCOVA|||Pain interference||-0.23|-1.28|0.0049
71771079|NCT00219544|143041743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.77|STANDARD_ERROR_OF_MEAN|0.26||0.0037||95.0|-1.29|-0.25|||ANCOVA|||Pain severity||-0.25|-1.29|0.0037
71888600|NCT02908100|143298306|SUPERIORITY||Absolute Difference|8.6||||0.234|TWO_SIDED|95.0|-21.4|38.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||38.7|-21.4|0.234
71888601|NCT02908100|143298306|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
71771080|NCT00219544|143041744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0719||95.0|0.0|0.11|||ANCOVA||pregabalin minus placebo|Health State Profile||0.11|-0.00|0.0719
71771081|NCT00219544|143041744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|2.54||0.418||95.0|-2.96|7.1|||ANCOVA||pregabalin minus placebo|Visual Analog Scale||7.10|-2.96|0.4180
71771082|NCT00282347|143041779|SUPERIORITY_OR_OTHER|||||||0.5538|TWO_SIDED||||||Stratified Wilcoxon-Rank Sum Test|||||||0.5538
71888602|NCT02908100|143298306|SUPERIORITY||Absolute Difference|15.2||||0.134|TWO_SIDED|95.0|-14.1|44.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||44.4|-14.1|0.134
71727753|NCT02075047|142969933|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.124|TWO_SIDED|95.0|-0.03|0.25|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.25|-0.03|0.124
71727754|NCT02075047|142969933|SUPERIORITY||Difference in LS mean|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.23|-0.01|0.084
71727755|NCT02075047|142969933|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|95.0|-0.02|0.2|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.20|-0.02|0.104
71888603|NCT02908100|143298306|SUPERIORITY||Absolute Difference|-7.1||||0.83|TWO_SIDED|95.0|-37.6|23.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.3|-37.6|0.830
71727756|NCT02075047|142969934|SUPERIORITY||Difference in LS mean|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.169|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.01|-0.06|0.169
71727757|NCT02075047|142969934|SUPERIORITY||Difference in LS mean|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.893|TWO_SIDED|95.0|-0.1|0.08|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.08|-0.10|0.893
71727758|NCT02075047|142969934|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.915|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.04|0.915
71727759|NCT02075047|142969934|SUPERIORITY||Difference in LS mean|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.289|TWO_SIDED|95.0|-0.01|0.04|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.04|-0.01|0.289
71727760|NCT02075047|142969935|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.145|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Change at Week 1: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.06|-0.01|0.145
71888604|NCT02908100|143298306|SUPERIORITY||Absolute Difference|-2.2||||0.963|TWO_SIDED|95.0|-32.1|27.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||27.8|-32.1|0.963
71888605|NCT02908100|143298307|SUPERIORITY||Absolute Difference|19.0||||0.189|TWO_SIDED|95.0|-9.4|47.5|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||47.5|-9.4|0.189
71888606|NCT02908100|143298307|SUPERIORITY||Absolute Difference|6.7||||0.909|TWO_SIDED|95.0|-21.9|35.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q1||35.2|-21.9|0.909
71727761|NCT02075047|142969935|SUPERIORITY||Difference in LS mean|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.148|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Change at Week 2: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.07|-0.01|0.148
71727762|NCT02075047|142969935|SUPERIORITY||Difference in LS mean|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.082|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||Change at Week 3: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.15|-0.01|0.082
71727763|NCT02075047|142969935|SUPERIORITY||Difference in LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||Change at Week 4: Results were obtained from a mixed effects repeated measures analysis of covariance model treatment, visit, visit-by-treatment interaction, and weight category as fixed effects and baseline score as a covariate along with participant as a random effect.||0.09|-0.00|0.070
71727764|NCT03552536|142969938|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. Least squares (LS) mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-0.6|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8583 and placebo at least 0.5 log10 copies/mL was 64%.|||||
71727765|NCT03061721|142969971|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71727766|NCT03061721|142969971|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71727767|NCT03061721|142969971|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71888607|NCT02908100|143298307|SUPERIORITY||Absolute Difference|-0.4||||0.5|TWO_SIDED|95.0|-29.2|28.4|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||28.4|-29.2|0.500
71888608|NCT02908100|143298307|SUPERIORITY||Absolute Difference|3.3||||0.234|TWO_SIDED|95.0|-27.1|33.8|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q2||33.8|-27.1|0.234
71888609|NCT02908100|143298307|SUPERIORITY||Absolute Difference|15.5||||0.364|TWO_SIDED|95.0|-14.9|46.0|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||46|-14.9|0.364
71888610|NCT02908100|143298307|SUPERIORITY||Absolute Difference|7.2||||0.31|TWO_SIDED|95.0|-22.0|36.3|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q3||36.3|-22|0.310
71727768|NCT03061721|142969972|SUPERIORITY|||||||0.5681|||||||ANCOVA|||||||0.5681
71727769|NCT03061721|142969972|SUPERIORITY|||||||0.4487|||||||ANCOVA|||||||0.4487
71727770|NCT03061721|142969972|SUPERIORITY|||||||0.0021|||||||ANCOVA|||||||0.0021
71727771|NCT03061721|142969973|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.0070
71727772|NCT03061721|142969973|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
71727773|NCT03061721|142969973|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
71727774|NCT03061721|142969974|SUPERIORITY|||||||0.2241|||||||ANCOVA|||||||0.2241
71727775|NCT03061721|142969974|SUPERIORITY|||||||0.0304|||||||ANCOVA|||||||0.0304
71727776|NCT03061721|142969974|SUPERIORITY|||||||0.0595|||||||ANCOVA|||||||0.0595
71727777|NCT03061721|142969975|SUPERIORITY|||||||0.0449|||||||ANCOVA|||||||0.0449
71727778|NCT03061721|142969975|SUPERIORITY|||||||0.0053|||||||ANCOVA|||||||0.0053
71727779|NCT03061721|142969975|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
71727780|NCT03061721|142969976|SUPERIORITY|||||||0.0045|||||||ANCOVA|||||||0.0045
71727781|NCT03061721|142969976|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
71727782|NCT03061721|142969976|SUPERIORITY|||||||0.0004|||||||ANCOVA|||||||0.0004
71727783|NCT03061721|142969985|SUPERIORITY|||||||0.2387|||||||ANCOVA|||||||0.2387
71727784|NCT03061721|142969985|SUPERIORITY|||||||0.1496|||||||ANCOVA|||||||0.1496
71727785|NCT03061721|142969985|SUPERIORITY|||||||0.0445|||||||ANCOVA|||||||0.0445
71888611|NCT02908100|143298307|SUPERIORITY||Absolute Difference|-2.1||||0.922|TWO_SIDED|95.0|-32.5|28.2|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||28.2|-32.5|0.922
71888612|NCT02908100|143298307|SUPERIORITY||Absolute Difference|-5.9||||0.701|TWO_SIDED|95.0|-35.4|23.7|||Cochran-Mantel-Haenszel|||Plasmablast Signature Level Q4||23.7|-35.4|0.701
71727786|NCT00457821|142970005|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
71727787|NCT00457821|142970006|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
71727788|NCT00457821|142970008|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.||||<0.05
71727789|NCT02139878|142970013|SUPERIORITY_OR_OTHER||||||=|0.088|||||||ANCOVA|||||||=0.088
71727790|NCT02139878|142970014|SUPERIORITY_OR_OTHER||||||=|0.98|||||||ANCOVA|||||||=0.980
71727791|NCT01632241|142970025|SUPERIORITY||Odds Ratio (OR)|1.4||||0.1068|TWO_SIDED|95.0|0.93|2.11|||Regression, Logistic|||||2.11|0.93|0.1068
71727792|NCT01632241|142970034|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0937|TWO_SIDED|95.0|0.94|2.15||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.15|0.94|0.0937
71727793|NCT01632241|142970036|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.2264|TWO_SIDED|95.0|0.51|1.17||Nominal p-value due to step-down sequential testing procedure.|Cox proportional hazards model|||||1.17|0.51|0.2264
71727794|NCT01632241|142970038|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4996|TWO_SIDED|95.0|0.61|2.8||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic|||||2.80|0.61|0.4996
71727795|NCT05032690|142970077|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|99.17|||||TWO_SIDED|90.0|93.72|104.93|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||104.93|93.72|
71727796|NCT05032690|142970077|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|135.9|||||TWO_SIDED|90.0|109.28|169.01|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||169.01|109.28|
71727797|NCT05032690|142970078|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|93.77|||||TWO_SIDED|90.0|90.08|97.61|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||97.61|90.08|
71727798|NCT05032690|142970078|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|162.54|||||TWO_SIDED|90.0|130.25|202.84|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted"||202.84|130.25|
71771083|NCT04480424|143041853|SUPERIORITY||Risk Difference|-4.0||||0.8275|TWO_SIDED|95.0|-22.3|14.5||p-value was calculated using Fisher's exact method with 5% level of significance to test the null hypothesis of no difference in mortality rate between the two treatment groups.|Fisher Exact|||||14.5|-22.3|0.8275
71888613|NCT02908100|143298308|SUPERIORITY||Absolute Difference|3.1||||0.692|TWO_SIDED|95.0|-10.9|17.1|||Cochran-Mantel-Haenszel|||Week 24||17.1|-10.9|0.692
71727799|NCT05032690|142970079|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|98.21|||||TWO_SIDED|90.0|93.83|102.8|||Mixed Models Analysis|||"For comparison of Bosutinib 4\*25 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fed, the model is a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 4\*25 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fed."||102.80|93.83|
71727800|NCT05032690|142970079|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|146.7|||||TWO_SIDED|90.0|117.88|182.58|||Mixed Models Analysis|||"For comparison of Bosutinib 1\*100 mg Capsule Fed vs. Bosutinib 1\*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect.~The reference treatment of Bosutinib 1\*100 mg Capsule Fed is Bosutinib 1\*100 mg Capsule Fasted."||182.58|117.88|
71727801|NCT00759356|142970087|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|Mean ratio|109.8||||||90.0|95.3|126.5|||ANOVA|||||126.5|95.3|
71727802|NCT00759356|142970089|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.5||||||90.0|95.6|107.9|||ANOVA|||||107.9|95.6|
71727803|NCT00759356|142970090|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|95.9|107.9|||ANOVA|log-transformation||||107.9|95.9|
71727804|NCT00835640|142970133|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|81.33||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
71727805|NCT00835640|142970134|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.87||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
71727806|NCT00835640|142970135|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|88.45||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.|||||
71727807|NCT00068250|142970136|OTHER||||||||||||||||||Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.|||
71727808|NCT00068250|142970137|SUPERIORITY|||||||0.006|||||||One-sample z-test|||Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)||||0.006
71727809|NCT00068250|142970138|OTHER|||||||0.82|||||||Chi-squared|One-sample test of proportions||RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.||||0.82
71727810|NCT00812006|142970140|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
71727811|NCT00812006|142970141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
71727812|NCT00812006|142970142|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
71727813|NCT00812006|142970143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's falsediscovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.||||||<0.001
71888614|NCT02908100|143298308|SUPERIORITY||Absolute Difference|1.9||||0.871|TWO_SIDED|95.0|-12.0|15.9|||Cochran-Mantel-Haenszel|||Week 24||15.9|-12|0.871
71888615|NCT02908100|143298308|SUPERIORITY||Absolute Difference|11.2||||0.105|TWO_SIDED|95.0|-2.8|25.1|||Cochran-Mantel-Haenszel|||Week 48||25.1|-2.8|0.105
71888616|NCT02908100|143298308|SUPERIORITY||Absolute Difference|7.7||||0.286|TWO_SIDED|95.0|-6.1|21.6|||Cochran-Mantel-Haenszel|||Week 48||21.6|-6.1|0.286
71888617|NCT02908100|143298309|SUPERIORITY||Absolute Difference|-1.6||||0.936|TWO_SIDED|95.0|-16.8|13.6|||Cochran-Mantel-Haenszel|||Week 24||13.6|-16.8|0.936
71771084|NCT04480424|143041854|SUPERIORITY|||||||0.8599||||||p-value was calculated using Gray's test for equality of the Cumulative Incidence Function (CIF) between treatment groups.|Gray's test|||||||0.8599
71771085|NCT04480424|143041855|SUPERIORITY||Least Square Mean (LSM) Difference|2.58||||0.2626|TWO_SIDED|95.0|-1.96|7.12||p-value was calculated using an Analysis of Variance (ANOVA) model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.12|-1.96|0.2626
71771086|NCT04480424|143041856|SUPERIORITY|||||||0.6854||||||p-value was calculated using Gray's test for equality of the CIF between treatment groups.|Gray's test|||||||0.6854
71771087|NCT04480424|143041857|SUPERIORITY||LSM Difference|-0.02||||0.9917|TWO_SIDED|95.0|-3.82|3.78||95% CI for difference in least square mean (LSM) between treatment groups and the associated p-value were calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||3.78|-3.82|0.9917
71771088|NCT04480424|143041858|SUPERIORITY||LSM Difference|0.05||||0.7557|TWO_SIDED|95.0|-0.29|0.4|||Kenward-Roger|p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.||||0.40|-0.29|0.7557
71771089|NCT04480424|143041859|SUPERIORITY||LSM Difference|0.4||||0.0922|TWO_SIDED|95.0|-0.07|0.86||p-value were calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||||0.86|-0.07|0.0922
71771090|NCT04480424|143041863|SUPERIORITY||Kenward-Roger|0.4||||0.3611|TWO_SIDED|95.0|-0.47|1.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.28|-0.47|0.3611
71831067|NCT02528188|143167422|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7076|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7076
71831068|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|-0.37|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.04|-0.37|0.0150
71888618|NCT02908100|143298309|SUPERIORITY||Absolute Difference|-2.9||||0.683|TWO_SIDED|95.0|-18.2|12.4|||Cochran-Mantel-Haenszel|||Week 24||12.4|-18.2|0.683
71888619|NCT02908100|143298309|SUPERIORITY||Absolute Difference|11.7||||0.086|TWO_SIDED|95.0|-3.4|26.8|||Cochran-Mantel-Haenszel|||Week 48||26.8|-3.4|0.086
71771091|NCT04480424|143041863|SUPERIORITY||Kenward-Roger|-0.1||||0.9238|TWO_SIDED|95.0|-2.13|1.94||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.94|-2.13|0.9238
71771092|NCT04480424|143041863|SUPERIORITY||Kenward-Roger|0.08||||0.9541|TWO_SIDED|95.0|-2.58|2.73||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||2.73|-2.58|0.9541
71888620|NCT02908100|143298309|SUPERIORITY||Absolute Difference|0.9||||0.879|TWO_SIDED|95.0|-14.2|16.1|||Cochran-Mantel-Haenszel|||Week 48||16.1|-14.2|0.879
71888621|NCT01688050|143298321|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|All-cause mortality rate (%)|2.0|||||TWO_SIDED|95.0|0.0|5.88|||||Wald method|||5.88|0|
71888622|NCT01688050|143298322|OTHER|The primary safety endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Aortic injury-related mortality rate (%)|0.0|||||TWO_SIDED|95.0|0.0|7.1|||||Exact method|||7.1|0|
71888623|NCT01688050|143298323|OTHER|The primary effectiveness endpoint of this study is analyzed using only descriptive statistics and it is not analyzed for the purpose of statistical inference|Device success rate (%)|96.0|||||TWO_SIDED|95.0|90.6|100.0|||||Wald method|||100|90.6|
71771093|NCT04480424|143041864|SUPERIORITY||LSM Difference|0.06||||0.9366|TWO_SIDED|95.0|-1.42|1.53||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|LSM Difference|||||1.53|-1.42|0.9366
71771094|NCT00734747|143041889|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
71771095|NCT02104739|143041899|SUPERIORITY|||||||0.27|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide at baseline and 2 hours after ingestion of meal is compared.||||0.27
71771096|NCT02104739|143041899|SUPERIORITY|||||||0.59|||||||Non-parametric Wilcoxon paired rank sum|||Saxagliptin at baseline and 2 hours after ingestion of meal is compared.||||0.59
71771097|NCT02104739|143041899|SUPERIORITY|||||||0.51|||||||Non-parametric Wilcoxon paired rank sum|||Placebo at baseline and 2 hours after ingestion of meal is compared.||||0.51
71771098|NCT02104739|143041899|SUPERIORITY|||||||0.31|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.||||0.31
71771099|NCT02104739|143041901|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
71771100|NCT02104739|143041903|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
71771101|NCT02104739|143041903|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
71771102|NCT02104739|143041905|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
71771103|NCT02104739|143041907|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).||||<0.05
71771104|NCT02104739|143041907|SUPERIORITY||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).||||<0.05
71771105|NCT02104739|143041909|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
71727814|NCT00812006|142970144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Nominal p-value was adjusted under Benjamini and Hochberg's false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.||||||<0.001
71727815|NCT00098748|142970155|NON_INFERIORITY_OR_EQUIVALENCE|For hypothesis of superiority, if upper bound of 97.5% confidence interval (CI) of TX difference was \<0 log10 copies/mL, it was concluded that MVC regimen was superior to PBO meaning that MVC added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone. If superiority could not be concluded, then a hypothesis of noninferiority was tested. If upper bound of CI is \<0.25 log10 copies/mL, noninferiority of MVC regimen to placebo was claimed.|Least squares mean|0.055|STANDARD_ERROR_OF_MEAN|0.2575|||TWO_SIDED|97.5|-0.528|0.638|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC versus (vs) PBO=advantage of MVC.|Maraviroc (MVC) QD versus placebo (PBO) treatment (TX) difference at Week 24. If upper bound of 97.5% confidence interval is \<0, it is concluded that dose is superior to PBO. If upper bound is \<0.25, it is concluded that MVC is non-inferior to PBO. Assumption: 79% of subjects are dual-tropic; total N=192 needed to be randomized to get N=150 dual-tropic. Standard deviation=0.8 with 2-sided p-value=0.025: 80% power for TX difference of 0.5 for change from baseline in log10-transformed viral load.||0.638|-0.528|
71727816|NCT00098748|142970155|SUPERIORITY_OR_OTHER||Least squares mean|-0.232|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|97.5|-0.829|0.364|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||0.364|-0.829|
71727817|NCT00098748|142970155|SUPERIORITY_OR_OTHER||Least squares mean|0.229|STANDARD_ERROR_OF_MEAN|0.2567|||TWO_SIDED|97.5|-0.351|0.81|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||0.810|-0.351|
71727818|NCT00098748|142970155|SUPERIORITY_OR_OTHER||Least squares mean|-0.261|STANDARD_ERROR_OF_MEAN|0.2628|||TWO_SIDED|97.5|-0.856|0.333|||ANCOVA|TX difference adjusted for randomization strata. Bonferroni adjustment for multiple comparisons by use of 2-sided 97.5% CI to maintain alpha=0.05.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||0.333|-0.856|
71727819|NCT00098748|142970156|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.12|0.18|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.18|-0.12|
71727820|NCT00098748|142970156|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.08|0.23|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.23|-0.08|
71727821|NCT00098748|142970156|SUPERIORITY_OR_OTHER||difference in proportions|0.02|||||TWO_SIDED|95.0|-0.12|0.17|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.17|-0.12|
71727822|NCT00098748|142970156|SUPERIORITY_OR_OTHER||difference in proportions|0.09|||||TWO_SIDED|95.0|-0.07|0.25|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.25|-0.07|
71727823|NCT00098748|142970157|SUPERIORITY_OR_OTHER||difference in proportions|0.03|||||TWO_SIDED|95.0|-0.15|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.15|
71727824|NCT00098748|142970157|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
71727825|NCT00098748|142970157|SUPERIORITY_OR_OTHER||difference in proportions|-0.06|||||TWO_SIDED|95.0|-0.22|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.22|
71727826|NCT00098748|142970157|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.07|0.28|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.28|-0.07|
71727827|NCT00098748|142970158|SUPERIORITY_OR_OTHER||difference in proportions|-0.05|||||TWO_SIDED|95.0|-0.21|0.12|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.12|-0.21|
71771106|NCT02104739|143041910|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).||||>0.05
71888624|NCT01214044|143298331|OTHER|A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.||||||0.2||||||A priori threshold for significance was p = 0.05.|t-test, 2 sided|paired t-test||A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).||||0.2
71727828|NCT00098748|142970158|SUPERIORITY_OR_OTHER||difference in proportions|0.08|||||TWO_SIDED|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.||0.26|-0.10|
71727829|NCT00098748|142970158|SUPERIORITY_OR_OTHER||difference in proportions|-0.02|||||TWO_SIDED|95.0|-0.18|0.13|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.13|-0.18|
71727830|NCT00098748|142970158|SUPERIORITY_OR_OTHER||difference in proportions|0.12|||||TWO_SIDED|95.0|-0.04|0.29|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.29|-0.04|
71727831|NCT00098748|142970159|SUPERIORITY_OR_OTHER||difference in proportions|0.07|||||TWO_SIDED|95.0|-0.07|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.||0.20|-0.07|
71727832|NCT00098748|142970159|SUPERIORITY_OR_OTHER||difference in proportions|0.11|||||TWO_SIDED|95.0|-0.03|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO difference in proportions at Week 24.||0.26|-0.03|
71727833|NCT00098748|142970159|SUPERIORITY_OR_OTHER||difference in proportions|-0.04|||||TWO_SIDED|95.0|-0.18|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.||0.10|-0.18|
71771107|NCT02104739|143041910|SUPERIORITY||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).||||>0.05
71771108|NCT05772702|143041911|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to FU2). Null hypothesis: D1 == FU2||||<0.0005
71771109|NCT05772702|143041912|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||t-test, 2 sided|||HDRS-17 change score were submitted to a t-test to estimate the group difference from 0 (i.e., no change in depression symptoms from D1 to D5). Note: D5 HDRS-17 were determined prior to receiving the final treatment on D5. Null hypothesis: D1 == D5||||<0.0005
71771110|NCT05772702|143041914|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||QIDS change score were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71771111|NCT05772702|143041915|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||ASRM scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 ASRM surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71658462|NCT01000493|142832080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.5719|TWO_SIDED|95.0|0.04|5.82|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||5.82|0.04|0.5719
71727834|NCT00098748|142970159|SUPERIORITY_OR_OTHER||difference in proportions|0.06|||||TWO_SIDED|95.0|-0.1|0.21|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.||0.21|-0.10|
71771112|NCT05772702|143041916|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||SHAPS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 SHAPS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71771113|NCT05772702|143041917|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 OVERALL scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71771114|NCT05772702|143041917|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|This subscale did not require sphericity corrections.||DASS-42 DEPRESSION SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71771115|NCT05772702|143041917|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 ANXIETY SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71888625|NCT01214044|143298332|OTHER|A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.||||||0.01||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.~A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.01
71888626|NCT01214044|143298333|OTHER|A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.||||||0.14||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.~A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."||||0.14
71727835|NCT00098748|142970160|SUPERIORITY_OR_OTHER||Least squares mean|23.927|STANDARD_ERROR_OF_MEAN|12.8025|||TWO_SIDED|95.0|-1.359|49.213|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||49.213|-1.359|
71727836|NCT00098748|142970160|SUPERIORITY_OR_OTHER||Least squares mean|26.679|STANDARD_ERROR_OF_MEAN|13.0678|||TWO_SIDED|95.0|0.869|52.49|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||52.490|0.869|
71727837|NCT00098748|142970160|SUPERIORITY_OR_OTHER||Least squares mean|14.61|STANDARD_ERROR_OF_MEAN|16.412|||TWO_SIDED|95.0|-17.8|47.03|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||47.03|-17.80|
71727838|NCT00098748|142970160|SUPERIORITY_OR_OTHER||Least squares mean|27.71|STANDARD_ERROR_OF_MEAN|16.754|||TWO_SIDED|95.0|-5.38|60.8|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||60.80|-5.38|
71727839|NCT00098748|142970161|SUPERIORITY_OR_OTHER||Least squares mean|234.499|STANDARD_ERROR_OF_MEAN|80.799|||TWO_SIDED|95.0|74.913|394.084|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.||394.084|74.913|
71727840|NCT00098748|142970161|SUPERIORITY_OR_OTHER||Least squares mean|188.817|STANDARD_ERROR_OF_MEAN|83.4484|||TWO_SIDED|95.0|23.999|353.635|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.||353.635|23.999|
71727841|NCT00098748|142970161|SUPERIORITY_OR_OTHER||Least squares mean|155.94|STANDARD_ERROR_OF_MEAN|87.304|||TWO_SIDED|95.0|-16.49|328.37|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.||328.37|-16.49|
71727842|NCT00098748|142970161|SUPERIORITY_OR_OTHER||Least squares mean|182.91|STANDARD_ERROR_OF_MEAN|90.174|||TWO_SIDED|95.0|4.81|361.02|||ANCOVA|TX difference adjusted for randomization strata.|Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.||361.02|4.81|
71727843|NCT00098748|142970162|SUPERIORITY_OR_OTHER|||||||0.7524||95.0|||||Log Rank|||MVC QD vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.7524
71727844|NCT00098748|142970162|SUPERIORITY_OR_OTHER|||||||0.254||95.0|||||Log Rank|||MVC BID vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.2540
71727845|NCT00098748|142970162|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||Log Rank|||MVC QD vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.8243
71727846|NCT00098748|142970162|SUPERIORITY_OR_OTHER|||||||0.6657||95.0|||||Log Rank|||MVC BID vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.||||0.6657
71727847|NCT00098748|142970163|SUPERIORITY_OR_OTHER||Least squares mean|0.069|STANDARD_ERROR_OF_MEAN|0.2356|||TWO_SIDED|95.0|-0.396|0.535|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 24.||0.535|-0.396|
71727848|NCT00098748|142970163|SUPERIORITY_OR_OTHER||Least squares mean|-0.218|STANDARD_ERROR_OF_MEAN|0.2413|||TWO_SIDED|95.0|-0.694|0.258|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 24.||0.258|-0.694|
71727849|NCT00098748|142970163|SUPERIORITY_OR_OTHER||Least squares mean|0.209|STANDARD_ERROR_OF_MEAN|0.2388|||TWO_SIDED|95.0|-0.262|0.681|||ANCOVA|TX difference adjusted for randomization strata.||MVC QD vs PBO treatment difference at Week 48.||0.681|-0.262|
71727850|NCT00098748|142970163|SUPERIORITY_OR_OTHER||Least squares mean|-0.284|STANDARD_ERROR_OF_MEAN|0.2445|||TWO_SIDED|95.0|-0.767|0.199|||ANCOVA|TX difference adjusted for randomization strata.||MVC BID vs PBO treatment difference at Week 48.||0.199|-0.767|
71771116|NCT05772702|143041917|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||DASS-42 STRESS SUBSCORES were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 DASS-42 surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71771117|NCT05772702|143041918|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.021|||||||ANOVA|Mauchly's test of sphericity determined the sphericity assumption was violated, so Greenhouse-Geisser corrections were applied.||STAI scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 STAI surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||0.021
71771118|NCT05772702|143041919|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||QIDS scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 QIDS surveys were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU1 = FU2||||<0.0005
71771119|NCT05772702|143041920|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.|||||<|0.0005|||||||ANOVA|||CGI severity scores were submitted to a repeated measures ANOVA to measure change from baseline over time. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D1 = D5 = FU2||||<0.0005
71771120|NCT05772702|143041920|OTHER|This was a single-arm, open-label trial. Reported statistics reflect changes from baseline levels.||||||0.006|||||||t-test, 2 sided|||CGI improvement scores were submitted to a paired t-test to measure difference between the improvement assessment on D5 and the assessment at FU2. Note: D5 CGI assessments were completed prior to receiving the final treatment on D5. Null hypothesis: D5 = FU2||||0.006
71727851|NCT01081301|142970184|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
71727852|NCT01081301|142970185|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
71727853|NCT01081301|142970186|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures||Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
71727854|NCT01081301|142970187|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||>0.05
71727855|NCT01081301|142970188|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.||||<0.05
71727856|NCT03551665|142970208|OTHER||Mean Difference (Final Values)|0.029||||0.036|TWO_SIDED|95.0|0.002|0.056|||Regression, Linear|||These data are the immediate improvements (base 2 - post 1) in the MS group.||0.056|.002|0.036
71888627|NCT01214044|143298334|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.06||||||Spearman's rho (rs) = 0.66|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.06
71888628|NCT01214044|143298334|OTHER|Spearman's rank-order correlation (non-parametric test) was used.||||||0.48||||||Spearman's rho (rs) = 0.02|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.||||0.48
71727857|NCT03551665|142970209|OTHER||Spearman's Rho|0.019||||0.92|||||||Spearman Correlation|||We correlated cognition (SDMT; above) to the improvement in performance (margin of stability) to to determine whether cognition predicted improvement in stepping outcomes.||||.92
71727858|NCT03551665|142970210|OTHER||Mean Difference (Final Values)|0.026||||0.119||95.0|-0.007|0.059|||Regression, Linear|||We assessed the change in reactive step length before (Baseline 2) to immediately after (post 1) training in the MS group||0.059|-0.007|0.119
71727859|NCT03551665|142970211|OTHER||Mean Difference (Final Values)|-0.041||||0.012||95.0|-0.073|-0.009|||Regression, Linear|||We assessed the change in reactive step latency before (Baseline 2) to immediately after (post 1) training in the MS group||-0.009|-0.073|0.012
71727860|NCT05538312|142970212|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|168.9|||||TWO_SIDED|90.0|157.66|180.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||180.94|157.66|
71727861|NCT05538312|142970213|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|152.19|||||TWO_SIDED|90.0|136.9|169.18|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.18|136.90|
71727862|NCT05538312|142970214|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|161.99|||||TWO_SIDED|90.0|148.7|176.47|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||176.47|148.70|
71727863|NCT05538312|142970215|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|153.13|||||TWO_SIDED|90.0|138.51|169.3|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.30|138.51|
71727864|NCT05538312|142970216|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|171.63|||||TWO_SIDED|90.0|159.96|184.15|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||184.15|159.96|
71727865|NCT05538312|142970217|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|157.8|||||TWO_SIDED|90.0|146.51|169.95|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUC120 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||169.95|146.51|
71727866|NCT05538312|142970222|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.86|||||TWO_SIDED|90.0|178.86|207.94|||||The ratios (and 90% CIs) are expressed as percentages.|ARV-471 administered alone as Reference, ARV-471 administered after multiple doses of itraconazole as Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||207.94|178.86|
71727867|NCT01545232|142970266|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.75||||0.12|TWO_SIDED|95.0|0.52|1.08|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. \& given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.||1.08|0.52|0.12
71727868|NCT01545232|142970267|SUPERIORITY_OR_OTHER||Adjusted Relative Risk|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12|||Mantel Haenszel|The critical level for significance (p\<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial's adaptive design. With 680 patients \& given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.||1.12|0.65|0.26
71727869|NCT01545232|142970269|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||van Elteren's test for medians|||||||0.83
71727870|NCT01545232|142970270|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||van Elteren's test for medians|||||||0.44
71727871|NCT01545232|142970272|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||van Elteren's test for medians|||||||0.11
71727872|NCT01545232|142970273|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-2.8|8.3||||||||8.3|-2.8|
71727873|NCT01545232|142970274|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.7||||||||1.7|-0.8|
71727874|NCT01545232|142970275|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||generalized logit model regression|||||||0.37
71727875|NCT01545232|142970276|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||van Elteren's test for medians|||||||0.14
71727876|NCT01545232|142970277|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||van Elteren's test for medians|||||||0.10
71727877|NCT00798317|142970307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.13|||<|0.001|TWO_SIDED|95.0|1.97|17.0||Comparing placebo and ocriplasmin|Fisher Exact|||||17.00|1.97|<0.001
71727878|NCT00489736|142970309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59|||<|0.0001||95.0|1.28|1.98||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of treatment failure for the dronedarone group compared with the amiodarone group.|||1.98|1.28|<0.0001
71727879|NCT00489736|142970310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.13||95.0|0.6|1.07||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of main safety event occurrence for the dronedarone group compared with the amiodarone group.|||1.07|0.60|0.13
71727880|NCT00489736|142970311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.002||95.0|0.44|0.84||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of MSE occurrence excluding gastrointestinal events, for the dronedarone group compared with the amiodarone group.|||0.84|0.44|0.002
71727881|NCT03920293|142970355|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.49|=|0.0009|TWO_SIDED|95.0|-2.6|-0.7||Statistical significance was tested at α=0.05.|MMRM|||||-0.7|-2.6|=0.0009
71727882|NCT03272828|142970373|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
71727883|NCT03272828|142970374|SUPERIORITY|||||||0.06|||||||Unequal-variance 2-sample t-test|||||||0.06
71727884|NCT03272828|142970375|SUPERIORITY|||||||0.45|||||||Unequal-variance 2-sample t-test|||||||0.45
71727885|NCT01920568|142970386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.192|||ANCOVA||Primary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (breast cancer, yes or no) and log transformed BL value as covariates.|||-0.192|-0.440|<0.0001
71727886|NCT01920568|142970387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.188|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, ie log\[(Wk 13 uNTx/Cr)/(BL uNTx/Cr)\] by ANCOVA model with trt group as main effect and the stratification factor (Chinese participants, yes or no) and log transformed BL value|||-0.188|-0.444|<0.0001
71727887|NCT01920568|142970388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.366|||<|0.0001|TWO_SIDED|95.0|-0.539|-0.193|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, i.e. log\[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)\] by ANCOVA model with trt group as main effect, stratification factor (Breast cancer, yes or no) and log transformed BL value as covariates.|||-0.193|-0.539|<0.0001
71727888|NCT06276881|142970404|SUPERIORITY|||||||0.37|||||||t-test, 1 sided||||Multiple regression analysis|||.37
71771121|NCT00902161|143041980|SUPERIORITY_OR_OTHER||Least Squared Mean Treatment Difference|32.0||||0.005|TWO_SIDED|95.0|15.0|49.0||There was only 1 primary hypothesis, so no multiplicity adjustment was required.|A linear mixed effect (LME) model|||The p-value is for testing the null hypothesis that the difference on Rt(65) between the \[MK-0893 1g + Propranolol\] vs. \[PBO + Propranolol\] \>=60 min. If p-value \< 0.05, then the null hypothesis is rejected at the significance level of 0.05, thus supporting the primary hypothesis that the treatment difference is less than 60 minutes.||49|15|0.005
71771122|NCT03150485|143042035|SUPERIORITY|Superiority was established is the lower limit of the 95% confidence interval was above 50%.|Estimated Proportion|77.27|||||TWO_SIDED|95.0|56.15|90.29|||Agresti-Coull|||The Agresti-Coull method was used to estimate the confidence interval of the binomial proportions of subjects with less than 2 lens modifications.||90.29|56.15|
71771123|NCT01966692|143042119|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|106.0||||0.4132|TWO_SIDED|90.0|99.0|114.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||114|99|0.4132
71888629|NCT04698525|143298339|NON_INFERIORITY|"A new treatment (memantine) that is not much worse or non-inferior to the standard treatment (valproate) may be attractive if, compared to it, it is expected to cause fewer side effects or improve quality of life or if its dosing regimen is easier to tolerate."|Mean Difference (Final Values)|5.3|STANDARD_DEVIATION|14.0||0.9|TWO_SIDED|95.0|0.0|10.0||"Comparison between VPA and Memantine was:~0.9 p-value (two-tailed)"|Wilcoxon (Mann-Whitney)|"Memantine 3.534 z corrected for ties 0.0004 p-value (two-tailed)~VPA 3.418 z corrected for ties 0.0006 p-value (two-tailed)"||Null hypothesis: Memantine is as effective as valproate in treating episodic migraine.|We made also student t|10|0|0.9
71888630|NCT05384041|143298344|SUPERIORITY|||||||0.056|||||||Regression, Linear|||Intent to Treat analyses||||0.056
71888631|NCT05384041|143298345|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Difference (Active - Control) at Week 1||||0.048
71888632|NCT05384041|143298346|SUPERIORITY|||||||0.2595|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2595
71888633|NCT05384041|143298346|SUPERIORITY|||||||0.1286|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1286
71727889|NCT06276881|142970405|SUPERIORITY|||||||0.07|||||||ANOVA|||||||.07
71727890|NCT03664674|142970407|SUPERIORITY||Mean Difference (Net)|-0.221|STANDARD_ERROR_OF_MEAN|0.218||0.312|TWO_SIDED|95.0|-0.648|0.207||Generalized Linear Model - Negative Binomial Regression Model with count data by subject transformed using the log-link function.|Regression, Linear|The parameter estimate + conf. int. results back-transform to the ratio of adjusted mean DVDs (OTO-104/Placebo) to be 0.802 (0.523, 1.230).||||0.207|-0.648|0.312
71727891|NCT02780856|142970462|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
71727892|NCT02780856|142970462|SUPERIORITY||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval||||<0.0001
71727893|NCT03640052|142970466|SUPERIORITY||Mean Difference (Final Values)|3.6|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
71727894|NCT03640052|142970466|SUPERIORITY||Mean Difference (Net)|-2.0|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
71727895|NCT03640052|142970466|SUPERIORITY||Mean Difference (Net)|-6.8|||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||>0.5
71727896|NCT03640052|142970466|SUPERIORITY||Mean Difference (Net)|-11.7||||0.33|TWO_SIDED||||||Mixed Models Analysis|||mean difference vs Placebo||||0.33
71727897|NCT03640052|142970467|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
71727898|NCT04239222|142970481|SUPERIORITY|A sample size of 22 subjects was required to provide 80% power to detect a difference of 5 points on the PLUS-M scale using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 7.7 was used to calculate the sample size.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|4.17||0.286|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot,|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean PLUS-M score using the Revo-M and μEveryday is the mean PLUS-M score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (11 negative, 8 positive and 4 null), Z=-1.066.|||0.286
71727899|NCT04239222|142970482|SUPERIORITY|A sample size of 21 subjects was required to provide 80% power to detect a difference of 0.2 points in the TAPES-AR score using Wilcoxon's matched pairs signed ranks test and alpha of 0.05. A standard deviation of 0.3 was used to calculate the sample size.|Mean Difference (Final Values)|-0.094|STANDARD_DEVIATION|0.212||0.031|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≥ μEveryday, μRevo-M is the mean TAPES-AR score using the Revo-M and μEveryday is the mean TAPES-AR score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (5 negative, 13 positive and 5 null), Z=-2.156|||0.031
71727900|NCT04239222|142970484|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_DEVIATION|8.29||0.421|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean ABC score using the Revo-M and μEveryday is the mean ABC score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (12 negative, 7 positive and 4 null), Z=-0.805.|||0.421
71727901|NCT04239222|142970485|SUPERIORITY||Mean Difference (Final Values)|0.087|STANDARD_DEVIATION|0.844||0.443|TWO_SIDED||||||Wilcoxon Signed Rank Test||Difference represents Revo-M - Everyday Foot.|HO: μRevo-M ≤ μEveryday, μRevo-M is the mean TAPES-FUN score using the Revo-M and μEveryday is the mean TAPES-FUN score using the Everyday foot at baseline.|2-sided Wilcoxon matched pairs signed ranks test, n=23 (6 negative, 9 positive and 8 null), Z=-0.767.|||0.443
71727902|NCT01468233|142970518|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|31.5|||<|0.001|TWO_SIDED|95.0|20.7|42.2||P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||42.2|20.7|<0.001
71727903|NCT01468233|142970518|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.5|||<|0.001|TWO_SIDED|95.0|10.5|40.5||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||40.5|10.5|<0.001
71727904|NCT01468233|142970518|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|38.1|||<|0.001|TWO_SIDED|95.0|22.8|53.3||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel|||||53.3|22.8|<0.001
71727905|NCT01468233|142970519|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|19.5|||=|0.01|TWO_SIDED|95.0|4.7|34.2||P-value adjusted for baseline antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||34.2|4.7|=0.01
71727906|NCT01468233|142970520|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|25.1|||<|0.001|TWO_SIDED|95.0|12.7|37.6||P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||37.6|12.7|<0.001
71727907|NCT01468233|142970521|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.4|||<|0.001|TWO_SIDED|95.0|-28.6|-10.1||P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.|ANCOVA|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.||-10.1|-28.6|<0.001
71727908|NCT03549871|142970562|SUPERIORITY||ABR ratio|0.389|||=|0.0008|TWO_SIDED|95.0|0.224|0.675||The threshold for significance was \<0.05.|Repeated measures NB regression model|||Analyzed using repeated measures NB model with fixed effect of treatment period (fitusiran efficacy period or factor/BPA prophylaxis period) and robust sandwich covariance matrix was constructed to account for within participant dependence, logarithm of duration (in years) that each participant spends in each study period matching BE data being analyzed as an offset variable.||0.675|0.224|=0.0008
71727909|NCT03549871|142970564|SUPERIORITY||ABR ratio|0.444|||||TWO_SIDED|95.0|0.234|0.842||||||||0.842|0.234|
71727910|NCT03549871|142970566|SUPERIORITY||ABR ratio|0.485|||||TWO_SIDED|95.0|0.259|0.91||||||||0.910|0.259|
71727911|NCT01133626|142970579|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be demonstrated if the lower limit of a two-sided 95% CI for the geometric mean ratio of BDP HFA 320 mcg/day to placebo was greater than 0.80.|geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|||||1.06|0.87|
71727912|NCT00294645|142970626|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Modified Peto-Peto|A one-sided test was used.||Null hypothesis: control rate = remote rate||||<0.0001
71727913|NCT01444027|142970653|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status||||||0.002
71727914|NCT01444027|142970653|SUPERIORITY|||||||0.9||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|||||||0.90
71727915|NCT01444027|142970653|SUPERIORITY|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.002
71727916|NCT01444027|142970654|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for the baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71727917|NCT01444027|142970654|SUPERIORITY|||||||0.48||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.48
71888634|NCT05384041|143298346|SUPERIORITY|||||||0.1449|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1449
71888635|NCT05384041|143298347|SUPERIORITY|||||||0.2065|||||||t-test, 2 sided|||Difference (Active-Control) at Week 1||||0.2065
71888636|NCT05384041|143298347|SUPERIORITY|||||||0.1349|||||||t-test, 2 sided|||Difference (Active-Control) at Week 2||||0.1349
71888637|NCT05384041|143298347|SUPERIORITY|||||||0.1142|||||||t-test, 2 sided|||Difference (Active-Control) at Week 4||||0.1142
71888638|NCT05384041|143298348|SUPERIORITY|||||||0.231|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.231
71888639|NCT05384041|143298348|SUPERIORITY|||||||0.192|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.192
71888640|NCT05384041|143298348|SUPERIORITY|||||||0.045|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.045
71727918|NCT01444027|142970654|SUPERIORITY|||||||0.01||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||.01
71727919|NCT01444027|142970655|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71727920|NCT01444027|142970655|SUPERIORITY|||||||0.83|||||||Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.83
71727921|NCT01444027|142970655|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71831069|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3286|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.25|0.3286
71831070|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0004
71888641|NCT05384041|143298350|SUPERIORITY|||||||0.005|||||||Regression, Linear|||||||0.005
71727922|NCT01444027|142970656|SUPERIORITY|||||||0.003||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.003
71727923|NCT01444027|142970656|SUPERIORITY|||||||0.16||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.16
71727924|NCT01444027|142970656|SUPERIORITY|||||||0.17||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.17
71727925|NCT01444027|142970657|SUPERIORITY|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.001
71727926|NCT01444027|142970657|SUPERIORITY|||||||0.78||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.78
71727927|NCT01444027|142970657|SUPERIORITY|||||||0.004||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.||||||0.004
71727928|NCT00737711|142970659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used to estimation of p-value.|t-test, 2 sided|||||||<0.0001
71727929|NCT04035564|142970687|SUPERIORITY||Risk Ratio (RR)|0.2||||0.71|TWO_SIDED|95.0|0.026|1.533|||Chi-squared|||||1.533|0.026|0.71
71727930|NCT04035564|142970688|SUPERIORITY||Risk Ratio (RR)|1.21||||0.89|TWO_SIDED|95.0|0.081|18.09|||Chi-squared|||||18.09|0.081|0.89
71727931|NCT04035564|142970689|SUPERIORITY||Mean Difference (Final Values)|-2.861|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||t-test, 2 sided|||||-0.261|-5.461|0.032
71727932|NCT04035564|142970689|SUPERIORITY||Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|1.286||0.032|TWO_SIDED|95.0|-5.461|-0.261|||ANOVA|||||-0.261|-5.461|0.032
71727933|NCT04035564|142970690|SUPERIORITY||Mean Difference (Final Values)|-3.788|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.858|||t-test, 2 sided|||||0.858|-8.43|0.107
71727934|NCT04035564|142970690|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|2.299||0.107|TWO_SIDED|95.0|-8.43|0.85|||ANOVA|||||0.85|-8.43|0.107
71727935|NCT04035564|142970691|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||t-test, 2 sided|||||-4.57|-74.18|0.028
71727936|NCT04035564|142970691|SUPERIORITY||Mean Difference (Final Values)|-39.38|STANDARD_ERROR_OF_MEAN|17.22||0.028|TWO_SIDED|95.0|-74.18|-4.57|||ANOVA|||||-4.57|-74.18|0.028
71727937|NCT04035564|142970692|SUPERIORITY||Risk Ratio (RR)|0.75||||0.55|TWO_SIDED|95.0|0.296|1.932|||Chi-squared|||||1.932|0.296|0.55
71727938|NCT04035564|142970693|SUPERIORITY||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.169|7.096|||Chi-squared|||||7.096|0.169|0.84
71727939|NCT04035564|142970694|SUPERIORITY||Risk Ratio (RR)|0.8||||0.7|TWO_SIDED|95.0|0.266|2.448|||Chi-squared|||||2.448|0.266|0.70
71727940|NCT04035564|142970695|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71727941|NCT04035564|142970695|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.57|TWO_SIDED||||||Regression, Cox|||||||0.57
71727942|NCT01007123|142970704|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|0.0|||||ANCOVA|||||||<0.2
71727943|NCT01007123|142970704|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|0.0|||||ANCOVA|||||||0.002
71727944|NCT01007123|142970704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71727945|NCT01007123|142970705|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
71727946|NCT01007123|142970705|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|0.0|||||Fisher Exact|||||||0.008
71727947|NCT01007123|142970705|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||Fisher Exact|||||||<0.001
71727948|NCT01007123|142970706|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|0.0|||||Fisher Exact|||||||0.06
71727949|NCT01007123|142970706|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|0.0|||||Fisher Exact|||||||0.03
71727950|NCT01007123|142970706|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|0.0|||||Fisher Exact|||||||0.04
71727951|NCT01007123|142970707|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|0.0|||||ANCOVA|||||||0.44
71727952|NCT01007123|142970707|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71727953|NCT01007123|142970707|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71727954|NCT01007123|142970708|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||0.01
71727955|NCT01007123|142970708|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|0.0|||||ANCOVA|||Comparison vs placebo||||<0.05
71888642|NCT05384041|143298351|SUPERIORITY|||||||0.0026|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.0026
71831071|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.17|-0.53|0.0001
71831072|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0517|TWO_SIDED|95.0|-0.37|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.37|0.0517
71888643|NCT05384041|143298351|SUPERIORITY|||||||0.4706|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.4706
71888644|NCT05384041|143298351|SUPERIORITY|||||||0.0197|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.0197
71888645|NCT05384041|143298351|SUPERIORITY|||||||0.4858|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.4858
71888646|NCT05384041|143298351|SUPERIORITY|||||||0.0183|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.0183
71888647|NCT05384041|143298351|SUPERIORITY|||||||0.7885|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.7885
71888648|NCT05384041|143298352|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||<0.001
71888649|NCT05384041|143298352|SUPERIORITY|||||||0.45|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.450
71658463|NCT01000493|142832080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.908||95.0|0.07|20.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||20.1|0.07|0.9080
71727956|NCT01007123|142970709|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|0.0|||||ANCOVA|||||||0.17
71727957|NCT01007123|142970709|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71727958|NCT01007123|142970709|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|0.0|||||ANCOVA|||||||<0.001
71727959|NCT00297102|142970711|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.0|STANDARD_ERROR_OF_MEAN|11.0||0.0003|TWO_SIDED|95.0|18.0|60.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||60|18|0.0003
71727960|NCT00297102|142970712|SUPERIORITY_OR_OTHER||Rate ratio|0.851|STANDARD_ERROR_OF_MEAN|0.062||0.0278|TWO_SIDED|95.0|0.737|0.982||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.982|0.737|0.0278
71727961|NCT00297102|142970713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.0001|TWO_SIDED|95.0|26.0|71.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||71|26|<0.0001
71727962|NCT00297102|142970714|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035|STANDARD_ERROR_OF_MEAN|0.357||0.9212|TWO_SIDED|95.0|0.526|2.034||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 765 in the roflumilast group, n= 758 in the placebo group).|||2.034|0.526|0.9212
71727963|NCT00297102|142970715|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|0.9521||||0.4089|TWO_SIDED|95.0|0.8472|1.0699||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.0699|0.8472|0.4089
71727964|NCT00297102|142970716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.111||0.0356|TWO_SIDED|95.0|0.016|0.449||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.449|0.016|0.0356
71727965|NCT01774097|142970724|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.238|TWO_SIDED|95.0|-0.6|2.5||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.5|-0.6|0.238
71727966|NCT01774097|142970725|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.116|TWO_SIDED|95.0|-0.2|2.1||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||2.1|-0.2|0.116
71727967|NCT01774097|142970726|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.978|TWO_SIDED|95.0|-0.8|0.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.8|-0.8|0.978
71727968|NCT01774097|142970727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.752|TWO_SIDED|95.0|-1.26|0.91||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided|||||0.91|-1.26|0.752
71727969|NCT01774097|142970728|SUPERIORITY_OR_OTHER||interaction term|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.871|TWO_SIDED|95.0|-0.02|0.03||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.03|-0.02|0.871
71727970|NCT01774097|142970729|SUPERIORITY_OR_OTHER||interaction term|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.256|TWO_SIDED|95.0|-0.06|0.02||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||0.02|-0.06|0.256
71727971|NCT01774097|142970730|SUPERIORITY_OR_OTHER||interaction term|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.241|TWO_SIDED|95.0|-0.2|0.6|||Regression, Linear|||||0.6|-0.2|0.241
71727972|NCT01774097|142970732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.131|TWO_SIDED|95.0|-0.6|4.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.8|-0.6|0.131
71727973|NCT01774097|142970733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.7||0.626|TWO_SIDED|95.0|-2.6|4.2||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.2|-2.6|0.626
71727974|NCT01774097|142970734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.591|TWO_SIDED|95.0|-4.1|2.3||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||2.3|-4.1|0.591
71727975|NCT01774097|142970735|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.0||0.722|TWO_SIDED|95.0|-3.3|4.7||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear|||||4.7|-3.3|0.722
71771124|NCT01966692|143042119|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|109.0||||0.1295|TWO_SIDED|90.0|102.0|116.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||116|102|0.1295
71727976|NCT04762043|142970746|SUPERIORITY||Mean Difference (Final Values)|56.55|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|53.33|59.76|||Mixed Models Analysis|Effect size used for mixed effects model is partial eta-squared (ηp2).||||59.76|53.33|<.001
71727977|NCT00090233|142970747|NON_INFERIORITY_OR_EQUIVALENCE|Relative Risk ≤10.0 (non-inferiority margin).|relative risk|1.6||||0.006||95.0|0.4|6.4||"p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.~Adjusted for group-sequential design."|Exact binomial test|Exact binomial test adjusted for group-sequential design.||||6.4|0.4|0.006
71727978|NCT00090233|142970748|SUPERIORITY_OR_OTHER||Proportion|81.2|||<|0.001||95.0|72.9|87.8||p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.|Exact binomial test|||||87.8|72.9|<0.001
71727979|NCT00090233|142970749|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|74.0|||<|0.001||95.0|66.8|79.9||"Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.~Based on conditional binomial approach."|Exact binomial test|Exact binomial test.|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||79.9|66.8|<0.001
71727980|NCT00090233|142970750|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|94.5|||<|0.001||95.0|91.2|96.6||Rate Reduction\>0%|Poisson regression|"Poisson regression with generalized estimating equations.~Validated with Van Elteren's extension of Wilcoxon Rank Sum test."|Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.|||96.6|91.2|<0.001
71727981|NCT00090233|142970751|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|81.5|||<|0.001||95.0|74.9|86.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Estimated value is based on the worst episode scores.|||86.7|74.9|<0.001
71727982|NCT00090233|142970752|SUPERIORITY_OR_OTHER||Efficacy=1-Relative Risk|98.0|||<|0.001||95.0|88.3|100.0||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact binomial test|||||100|88.3|<0.001
71771125|NCT01966692|143042119|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for AUC0-last fell completely within (80%, 125%).|ratio (%) of geometric means|114.0||||0.0078|TWO_SIDED|90.0|106.0|122.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed AUC0-last: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||122|106|0.0078
71831073|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.61|-0.23|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.61|<0.0001
71831074|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3621|TWO_SIDED|95.0|-0.37|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.37|0.3621
71888650|NCT05384041|143298352|SUPERIORITY|||||||0.008|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.008
71727983|NCT00090233|142970753|NON_INFERIORITY_OR_EQUIVALENCE|Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).|||||<|0.001||95.0||||p\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.|Miettenen and Nurminen|||||||<0.001
71888651|NCT05384041|143298352|SUPERIORITY|||||||0.438|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.438
71888652|NCT05384041|143298352|SUPERIORITY|||||||0.016|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.016
71727984|NCT00090233|142970754|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis PT|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.||1.1|0.7|<0.001
71727985|NCT00090233|142970754|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis FHA|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.||1.1|0.7|<0.001
71831075|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0832|TWO_SIDED|95.0|-0.47|0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.47|0.0832
71727986|NCT00090233|142970754|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis Pertactin|0.6||||0.193|TWO_SIDED|95.0|0.4|0.8|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.||0.8|0.4|0.193
71727987|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 4|1.2|||<|0.001||95.0|1.0|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.||1.4|1.0|<0.001
71727988|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 6B|1.4|||<|0.001|TWO_SIDED|95.0|1.0|1.9|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.||1.9|1.0|<0.001
71727989|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 9V|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.||1.3|0.9|<0.001
71727990|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 14|1.0|||<|0.001|TWO_SIDED|95.0|0.7|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.||1.3|0.7|<0.001
71727991|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 18C|1.3|||<|0.001|TWO_SIDED|95.0|1.1|1.6|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.||1.6|1.1|<0.001
71727992|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 19F|1.1|||<|0.001|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.||1.4|0.8|<0.001
71727993|NCT00090233|142970755|NON_INFERIORITY_OR_EQUIVALENCE|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 23F|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.5|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.||1.5|0.9|<0.001
71727994|NCT01057225|142970810|SUPERIORITY_OR_OTHER||Dose Level|1.0|||||TWO_SIDED||||||||Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m\^2 for the first cycle and 36 mg/m\^2 for subsequent cycles.|||||
71727995|NCT04600505|142970837|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|111.7|||||TWO_SIDED|90.0|91.01|137.1||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||137.1|91.01|
71727996|NCT04600505|142970837|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.78|||||TWO_SIDED|90.0|78.67|124.0||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||124.0|78.67|
71727997|NCT04600505|142970837|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|108.3|||||TWO_SIDED|90.0|85.5|137.3||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||137.3|85.50|
71727998|NCT04600505|142970837|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|94.88|||||TWO_SIDED|90.0|74.69|120.5||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||120.5|74.69|
71888653|NCT05384041|143298352|SUPERIORITY|||||||0.355|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.355
71888654|NCT05384041|143298353|SUPERIORITY|||||||0.046|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.046
71727999|NCT04600505|142970837|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|109.1|||||TWO_SIDED|90.0|97.02|122.7||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||122.7|97.02|
71728000|NCT04600505|142970837|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|100.1||||||90.0|83.78|119.5||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||119.5|83.78|
71728001|NCT04600505|142970838|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|104.7|||||TWO_SIDED|90.0|91.95|119.2||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||119.2|91.95|
71728002|NCT04600505|142970838|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.03|||||TWO_SIDED|90.0|83.33|115.3||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.3|83.33|
71728003|NCT04600505|142970838|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|96.0||||||90.0|70.33|131.0||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||131.0|70.33|
71728004|NCT04600505|142970838|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|116.7||||||90.0|86.31|157.8||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||157.8|86.31|
71888655|NCT05384041|143298353|SUPERIORITY|||||||0.351|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.351
71888656|NCT05384041|143298353|SUPERIORITY|||||||0.053|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.053
71831076|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4072|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4072
71658464|NCT01000493|142832080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9486|TWO_SIDED|95.0|0.07|12.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||12.5|0.07|0.9486
71728005|NCT04600505|142970839|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.3|||||TWO_SIDED|90.0|94.53|121.9||||||Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)||121.9|94.53|
71728006|NCT04600505|142970839|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.8|||||TWO_SIDED|90.0|84.59|115.4||||||Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)||115.4|84.59|
71728007|NCT04600505|142970839|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|106.1|||||TWO_SIDED|90.0|86.18|130.6||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)||130.6|86.18|
71728008|NCT04600505|142970839|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|99.71|||||TWO_SIDED|90.0|80.84|123.0||||||Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)||123.0|80.84|
71728009|NCT04600505|142970839|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|98.13|||||TWO_SIDED|90.0|86.44|111.4||||||Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)||111.4|86.44|
71728010|NCT04600505|142970839|OTHER|Results based on linear mixed-effects analysis of variance model|Geometric mean Ratio (%)|107.0|||||TWO_SIDED|90.0|88.82|128.9||||||Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)||128.9|88.82|
71728011|NCT04065074|142970863|OTHER|Proportion of Successful Administrations|Proportion of Successful Administrations|0.75|||||TWO_SIDED|90.0|0.51|0.9||||||||0.90|0.51|
71728012|NCT00871117|142970864|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% confidence interval (CI) for the between-group differences in booster response to diphtheria was greater than or equal to (≥)-10%.|Difference in booster response rates|0.01|||||TWO_SIDED|95.0|-2.54|2.58||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of diphtheria (D) booster response one month after vaccination with DTaP-IPV vaccine.||2.58|-2.54|
71728013|NCT00871117|142970864|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to tetanus was ≥ -10%.|Difference in booster response rates|0.98|||||TWO_SIDED|95.0|-1.99|4.26||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of tetanus (T) booster response one month after vaccination with DTaP-IPV vaccine.||4.26|-1.99|
71728014|NCT00871117|142970865|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PT was ≥ -10%|Difference in booster response rates|-0.76|||||TWO_SIDED|95.0|-5.07|3.51||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertussis toxoid (PT) booster response one month after vaccination with DTaP-IPV vaccine.||3.51|-5.07|
71728015|NCT00871117|142970865|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to FHA was ≥ -10%.|Difference in booster response rates|-0.91|||||TWO_SIDED|95.0|-3.59|1.39||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of filamentous hemagglutinin (FHA) booster response one month after vaccination with DTaP-IPV vaccine.||1.39|-3.59|
71728016|NCT00871117|142970865|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PRN, was ≥ -10%.|Difference in booster response rates|1.42|||||TWO_SIDED|95.0|-0.32|4.08||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertactin (PRN) booster response one month after vaccination with DTaP-IPV vaccine.||4.08|-0.32|
71728017|NCT00871117|142970866|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios for poliovirus type 1 antigens was ≥ 0.67.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.76|1.1||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 1 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.1|0.76|
71728018|NCT00871117|142970866|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 2 antigens was ≥ 0.67.|Adjusted GMT ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 2 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||0.99|0.7|
71728019|NCT00871117|142970866|NON_INFERIORITY|Lower limit of the 95% CI for the GMT ratios of poliovirus type 3 antigens was ≥ 0.67.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|1.01||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 3 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.||1.01|0.71|
71728020|NCT03385265|142970883|SUPERIORITY||partial eta squared|0.02|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71728021|NCT03385265|142970884|SUPERIORITY||partial eta squared|0.12|||||TWO_SIDED||||||repeated measures ANOVA|CESD-R = within subject variable; group = between subject variable||||||
71728022|NCT03385265|142970885|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71888657|NCT05384041|143298353|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.120
71888658|NCT05384041|143298353|SUPERIORITY|||||||0.17|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.170
71728023|NCT03385265|142970886|SUPERIORITY||partial eta squared|0.06|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71728024|NCT03385265|142970887|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71728025|NCT03385265|142970888|SUPERIORITY||partial eta squared|0.04|||<|0.05|TWO_SIDED||||||repeated measures ANOVA|||||||<0.05
71728026|NCT03385265|142970889|SUPERIORITY||partial eta squared|0.24|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71728027|NCT03385265|142970890|SUPERIORITY||partial eta squared|0.03|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71728028|NCT03385265|142970891|SUPERIORITY||partial eta squared|0.04|||||TWO_SIDED||||||repeated measures ANOVA|||||||
71728029|NCT00395135|142970897|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.0001|TWO_SIDED|95.0|3.0|4.2|||ANCOVA|||||4.2|3.0|<0.0001
71771126|NCT01966692|143042120|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|182.0|||<|0.001|TWO_SIDED|90.0|159.0|208.0||The threshold for statistical significane was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 2 (B-3.8 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||208|159|<0.001
71831077|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.3404|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.13|-0.39|0.3404
71728030|NCT00395135|142970899|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-3.67|||<|0.001|TWO_SIDED|95.0|-4.09|-3.25|||ANCOVA|||||-3.25|-4.09|<0.001
71728031|NCT00395135|142970900|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.29|-1.88|||ANCOVA|||||-1.88|-3.29|<0.001
71728032|NCT00395135|142970900|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportion (%)|1.64|||<|0.001|TWO_SIDED|95.0|1.1|2.19|||ANCOVA|||||2.19|1.10|<0.001
71728033|NCT02323204|142970901|OTHER|||||||0.6298|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6298
71831078|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6344|TWO_SIDED|95.0|-0.34|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.34|0.6344
71888659|NCT05384041|143298353|SUPERIORITY|||||||0.122|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.122
71728034|NCT02323204|142970901|OTHER|||||||0.2341|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2341
71728035|NCT02323204|142970902|OTHER|||||||0.7893|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7893
71728036|NCT02323204|142970902|OTHER|||||||0.2951|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2951
71728037|NCT02323204|142970903|OTHER|||||||0.7166|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7166
71728038|NCT02323204|142970903|OTHER|||||||0.4501|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4501
71888660|NCT05384041|143298354|SUPERIORITY|||||||0.044|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.044
71888661|NCT05384041|143298354|SUPERIORITY|||||||0.751|||||||Regression, Linear|||Difference (Active-Control) at Week 1||||0.751
71888662|NCT05384041|143298354|SUPERIORITY|||||||0.013|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.013
71888663|NCT05384041|143298354|SUPERIORITY|||||||0.318|||||||Regression, Linear|||Difference (Active-Control) at Week 2||||0.318
71888664|NCT05384041|143298354|SUPERIORITY|||||||0.173|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.173
71888665|NCT05384041|143298354|SUPERIORITY|||||||0.142|||||||Regression, Linear|||Difference (Active-Control) at Week 4||||0.142
71888666|NCT05384041|143298355|SUPERIORITY|||||||0.026|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.026
71728039|NCT02323204|142970904|OTHER|||||||0.6756|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.6756
71728040|NCT02323204|142970904|OTHER|||||||0.5381|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5381
71728041|NCT02323204|142970905|OTHER|||||||0.1507|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.1507
71728042|NCT02323204|142970905|OTHER|||||||0.0769|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0769
71728043|NCT02323204|142970906|OTHER|||||||0.0654|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0654
71728044|NCT02323204|142970906|OTHER|||||||0.7957|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.7957
71728045|NCT02323204|142970907|OTHER|||||||0.0286|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0286
71728046|NCT02323204|142970907|OTHER|||||||0.0201|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0201
71728047|NCT02323204|142970908|OTHER|||||||0.9928|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.9928
71728048|NCT02323204|142970908|OTHER|||||||0.0982|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0982
71728049|NCT02323204|142970909|OTHER|||||||0.0325|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.0325
71728050|NCT02323204|142970909|OTHER|||||||0.2568|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.2568
71728051|NCT02323204|142970910|OTHER|||||||0.5824|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.5824
71728052|NCT02323204|142970910|OTHER|||||||0.4635|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."||||0.4635
71728053|NCT02323204|142970911|OTHER|||||||0.7949|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation over time between interventions was made through the intervention-time interaction effect included in the model. Significance in the interaction effect is indicative of a difference in the rate of change in implementation between interventions over time.||||0.7949
71888667|NCT05384041|143298355|SUPERIORITY|||||||0.241|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.241
71728054|NCT02323204|142970911|OTHER|||||||0.0003|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation between interventions was made through the intervention main effect included in the model. The model at hand does not contain an interaction between intervention and time. Significance in the main intervention effect is indicative of a difference in implementation between intervention groups.||||0.0003
71888668|NCT05384041|143298355|SUPERIORITY|||||||0.059|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.059
71728055|NCT03831880|142970915|SUPERIORITY||Mean Difference (Final Values)|-15.49|||<|0.0001|TWO_SIDED|95.0|-19.71|-11.27||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-11.27|-19.71|<0.0001
71728056|NCT03831880|142970917|SUPERIORITY||Mean Difference (Final Values)|-5.39||||0.0017|TWO_SIDED|95.0|-8.69|-2.09||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-2.09|-8.69|0.0017
71728057|NCT03831880|142970919|SUPERIORITY||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-19.74|-7.45||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-7.45|-19.74|<0.0001
71728058|NCT03831880|142970921|SUPERIORITY||Mean Difference (Final Values)|-24.34|||<|0.0001|TWO_SIDED|95.0|-30.1|-18.57||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-18.57|-30.10|<0.0001
71728059|NCT03831880|142970923|SUPERIORITY||Mean Difference (Final Values)|-7.83||||0.0739|TWO_SIDED|95.0|-16.42|0.77||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||0.77|-16.42|0.0739
71728060|NCT03831880|142970925|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.0001|TWO_SIDED|95.0|-25.15|-10.06||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.06|-25.15|<0.0001
71728061|NCT03831880|142970927|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.6137|TWO_SIDED|95.0|-2.09|3.51||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||3.51|-2.09|0.6137
71728062|NCT03831880|142970929|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.8404|TWO_SIDED|95.0|-5.29|6.41||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||6.41|-5.29|0.8404
71728063|NCT03831880|142970931|SUPERIORITY||Mean Difference (Final Values)|-13.47|||<|0.0001|TWO_SIDED|95.0|-17.59|-9.35||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-9.35|-17.59|<0.0001
71728064|NCT03831880|142970933|SUPERIORITY||Mean Difference (Final Values)|-2.76||||0.0245|TWO_SIDED|95.0|-5.16|-0.36||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-0.36|-5.16|0.0245
71728065|NCT03831880|142970945|SUPERIORITY||Mean Difference (Final Values)|-14.58|||<|0.0001|TWO_SIDED|95.0|-18.72|-10.44||95% CI: Model-based difference in means. Results were based on a linear mixed effects model including sequence, period, and treatment as fixed effects and participant within sequence and within-participant error as random effects.|Mixed Models Analysis|||||-10.44|-18.72|<0.0001
71728066|NCT01852825|142970952|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.355||||0.003|TWO_SIDED|90.0|1.515|3.661|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.661|1.515|0.003
71831079|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5756|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.19|-0.35|0.5756
71831080|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4394|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.38|0.4394
71888669|NCT05384041|143298355|SUPERIORITY|||||||0.478|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.478
71888670|NCT05384041|143298355|SUPERIORITY|||||||0.009|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.009
71728067|NCT01852825|142970953|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.182||||0.01|TWO_SIDED|90.0|1.364|3.49|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is \>1.0.||3.490|1.364|0.010
71728068|NCT01852825|142970954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.027|TWO_SIDED|90.0|0.066|0.41|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|The hypothesis is supported if the lower bound of the 1-tailed 95% CI around the mean difference in change from baseline excludes zero||0.410|0.066|0.027
71728069|NCT01852825|142970955|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.068||||0.935|TWO_SIDED|90.0|0.272|4.19|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||4.190|0.272|0.935
71728070|NCT01852825|142970956|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.21||||0.296|TWO_SIDED|90.0|0.605|8.066|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|||8.066|0.605|0.296
71728071|NCT01852825|142970957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.115||||0.014|TWO_SIDED|90.0|-100.185|-22.045|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|||-22.045|-100.185|0.014
71728072|NCT01327274|142970960|OTHER|Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.||||||0.486|||||||Wilcoxon (Mann-Whitney)|||||||0.486
71728073|NCT01095653|142970967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.0975|<|0.0001|TWO_SIDED|95.0|-0.94|-0.56||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.56|-0.94|<0.0001
71728074|NCT01095653|142970967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.0962|<|0.0001|TWO_SIDED|95.0|-1.01|-0.63||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.63|-1.01|<0.0001
71728075|NCT01095653|142970968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.7|STANDARD_ERROR_OF_MEAN|3.203|<|0.0001|TWO_SIDED|95.0|-34.0|-21.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-21.4|-34.0|<0.0001
71728076|NCT01095653|142970968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.2|STANDARD_ERROR_OF_MEAN|3.174|<|0.0001|TWO_SIDED|95.0|-40.4|-27.9||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-27.9|-40.4|<0.0001
71728077|NCT01095653|142970969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|6.5667|<|0.0001|TWO_SIDED|95.0|-60.8|-34.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-34.96|-60.80|<0.0001
71728078|NCT01095653|142970969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.0|STANDARD_ERROR_OF_MEAN|6.4489|<|0.0001|TWO_SIDED|95.0|-68.66|-43.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-43.28|-68.66|<0.0001
71728079|NCT01095653|142970970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3259|<|0.0001|TWO_SIDED|95.0|-2.01|-0.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.73|-2.01|<0.0001
71728080|NCT01095653|142970970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.3242|<|0.0001|TWO_SIDED|95.0|-2.62|-1.34||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.34|-2.62|<0.0001
71728081|NCT01095653|142970971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.3|STANDARD_ERROR_OF_MEAN|5.238|<|0.0001|TWO_SIDED|95.0|11.1|31.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||31.6|11.1|<0.0001
71728082|NCT01095653|142970971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5|STANDARD_ERROR_OF_MEAN|5.022|<|0.0001|TWO_SIDED|95.0|18.6|38.3||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||38.3|18.6|<0.0001
71728083|NCT02752958|142970977|OTHER||Mean Difference (Final Values)|5.89||||0.0944|TWO_SIDED|95.0|-1.018|12.8|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (Baseline ) versus (vs.) Week 4||12.80|-1.018|0.0944
71728084|NCT02752958|142970978|OTHER||Mean Difference (Final Values)|16.99|||<|0.0001|TWO_SIDED|95.0|10.128|23.849|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 8||23.849|10.128|<0.0001
71775088|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.8|TWO_SIDED|95.0|-3.18|2.46||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.46|-3.18|0.80
71888671|NCT05384041|143298355|SUPERIORITY|||||||0.729|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.729
71728085|NCT02752958|142970979|OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|15.87|29.539|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 12||29.539|15.870|<0.0001
71728086|NCT02752958|142970980|OTHER||Mean Difference (Final Values)|27.21|||<|0.0001|TWO_SIDED|95.0|20.245|34.165|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 16||34.165|20.245|<0.0001
71728087|NCT02752958|142970981|OTHER||Mean Difference (Final Values)|31.42|||<|0.0001|TWO_SIDED|95.0|24.464|38.385|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||38.385|24.464|<.0001
71888672|NCT05384041|143298356|SUPERIORITY|||||||0.044|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.044
71888673|NCT05384041|143298356|SUPERIORITY|||||||0.067|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.067
71888674|NCT05384041|143298356|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
71888675|NCT05384041|143298356|SUPERIORITY|||||||0.006|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.006
71888676|NCT05384041|143298356|SUPERIORITY|||||||0.036|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.036
71888677|NCT05384041|143298356|SUPERIORITY|||||||0.016|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.016
71728088|NCT02752958|142970982|OTHER||Mean Difference (Final Values)|32.55|||<|0.0001|TWO_SIDED|95.0|25.585|39.506|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 24||39.506|25.585|<.0001
71728089|NCT02752958|142970983|OTHER||Mean Difference (Final Values)|1.18||||0.0312|TWO_SIDED|95.0|0.108|2.262|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 4||2.262|0.108|0.0312
71728090|NCT02752958|142970984|OTHER||Mean Difference (Final Values)|2.8|||<|0.0001|TWO_SIDED|95.0|1.728|3.866|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||3.866|1.728|<.0001
71728091|NCT02752958|142970985|OTHER||Mean Difference (Final Values)|3.26|||<|0.0001|TWO_SIDED|95.0|2.192|4.322|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||4.322|2.192|<.0001
71728092|NCT02752958|142970986|OTHER||Mean Difference (Final Values)|3.93|||<|0.0001|TWO_SIDED|95.0|2.844|5.012|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||5.012|2.844|<.0001
71771127|NCT01966692|143042120|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|190.0|||<|0.001|TWO_SIDED|90.0|166.0|217.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm); Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||217|166|<0.001
71771128|NCT01966692|143042120|EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of geometric means for Cmax fell completely within (80%, 125%).|ratio (%) of geometric means|213.0|||<|0.001|TWO_SIDED|90.0|186.0|244.0||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||Mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Test: Fluticasone Propionate Formulation 3 (C-3.7 µm)\*; Reference: Fluticasone Propionate Formulation 1 (A-4.5 µm); Natural log transformed Cmax: mixed models analysis with sequence, period, treatment as fixed effects and subject within sequence as a random effect.~All reported p-values are Bonferroni adjusted p-values."||244|186|<0.001
71771129|NCT02397564|143042130|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
71771130|NCT03584373|143042132|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.14||||0.7|TWO_SIDED|95.0|-0.89|0.6|||t-test, 2 sided|||||0.60|-0.89|0.70
71728093|NCT02752958|142970987|OTHER||Mean Difference (Final Values)|4.15|||<|0.0001|TWO_SIDED|95.0|3.063|5.232|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||5.232|3.063|<.0001
71728094|NCT02752958|142970988|OTHER||Mean Difference (Final Values)|4.74|||<|0.0001|TWO_SIDED|95.0|3.654|5.823|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.823|3.654|<.0001
71728095|NCT02752958|142970989|OTHER||Mean Difference (Final Values)|1.11||||0.4185|TWO_SIDED|95.0|-1.592|3.821|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 4||3.821|-1.592|0.4185
71728096|NCT02752958|142970990|OTHER||Mean Difference (Final Values)|7.08|||<|0.0001|TWO_SIDED|95.0|4.391|9.764|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||9.764|4.391|<.0001
71771131|NCT03584373|143042133|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.23||||0.58|TWO_SIDED|95.0|-1.08|0.61|||t-test, 2 sided|||||0.61|-1.08|0.58
71771132|NCT03584373|143042134|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.91||||0.006|TWO_SIDED|95.0|-3.25|-0.56|||t-test, 2 sided|||||-0.56|-3.25|0.006
71771133|NCT03584373|143042135|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-1.16||||0.04|TWO_SIDED|95.0|-2.26|-0.06|||t-test, 2 sided|||||-0.06|-2.26|0.04
71771134|NCT03584373|143042136|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|-0.55||||0.33|TWO_SIDED|95.0|-1.67|0.56|||t-test, 2 sided|||||0.56|-1.67|0.33
71771135|NCT03584373|143042137|NON_INFERIORITY|Non-inferiority margin of 1.3|Mean Difference (Net)|0.06||||0.47|TWO_SIDED|95.0|-0.1|0.21|||t-test, 2 sided|||||0.21|-0.10|0.47
71771136|NCT01155479|143042163|SUPERIORITY_OR_OTHER||Difference in Estimated Means|2.6||||0.0033|TWO_SIDED|95.0|0.86|4.3|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||4.30|0.86|0.0033
71888678|NCT05384041|143298356|SUPERIORITY|||||||0.914|||||||Chi-squared|||Difference (Active-Control) at Week 1||||0.914
71888679|NCT05384041|143298356|SUPERIORITY|||||||0.887|||||||Chi-squared|||Difference (Active-Control) at Week 2||||0.887
71888680|NCT05384041|143298356|SUPERIORITY|||||||0.791|||||||Chi-squared|||Difference (Active-Control) at Week 4||||0.791
71728097|NCT02752958|142970991|OTHER||Mean Difference (Final Values)|8.35|||<|0.0001|TWO_SIDED|95.0|5.674|11.026|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 12||11.026|5.674|<.0001
71728098|NCT02752958|142970992|OTHER|Week 0 Vs Week 16|Mean Difference (Final Values)|10.43|||<|0.0001|TWO_SIDED|95.0|7.708|13.158|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||13.158|7.708|<.0001
71888681|NCT02086331|143298357|OTHER||||||||||||||||||Intraclass correlation of repeated measures - 0.96, p=0.08|||
71888682|NCT00510276|143298359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82||||0.005|TWO_SIDED|95.0|1.44|8.2||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.20|1.44|0.005
71888683|NCT00510276|143298360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.006|TWO_SIDED|95.0|1.68|10.12||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.12|1.68|0.006
71888684|NCT00510276|143298361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73||||0.018|TWO_SIDED|95.0|1.0|10.46||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||10.46|1.00|0.018
71888685|NCT00510276|143298362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36||||0.034|TWO_SIDED|95.0|0.33|8.39||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||8.39|0.33|0.034
71888686|NCT00510276|143298363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.074|TWO_SIDED|95.0|-0.33|7.12||A gate-keeper strategy was applied to adjust for multiple tests.|ANCOVA|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||7.12|-0.33|0.074
71728099|NCT02752958|142970993|OTHER||Mean Difference (Final Values)|11.73|||<|0.0001|TWO_SIDED|95.0|9.008|14.459|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||14.459|9.008|<.0001
71728100|NCT02752958|142970994|OTHER||Mean Difference (Final Values)|11.96|||<|0.0001|TWO_SIDED|95.0|9.235|14.686|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||14.686|9.235|<.0001
71728101|NCT02752958|142970995|OTHER||Mean Difference (Final Values)|0.57||||0.3415|TWO_SIDED|95.0|-0.604|1.738|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 4||1.738|-0.604|0.3415
71728102|NCT02752958|142970996|OTHER||Mean Difference (Final Values)|1.77||||0.0029|TWO_SIDED|95.0|0.61|2.935|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 8||2.935|0.610|0.0029
71728103|NCT02752958|142970997|OTHER||Mean Difference (Final Values)|2.42|||<|0.0001|TWO_SIDED|95.0|1.266|3.582|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||3.582|1.266|<0.0001
71728104|NCT02752958|142970998|OTHER||Mean Difference (Final Values)|3.55|||<|0.0001|TWO_SIDED|95.0|2.371|4.729|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||4.729|2.371|<.0001
71771137|NCT01155479|143042163|SUPERIORITY_OR_OTHER||Difference in Estimated Means|1.3||||0.1382|TWO_SIDED|95.0|-0.41|2.94|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||2.94|-0.41|0.1382
71888687|NCT00510276|143298364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.63|-0.24|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.24|-0.63|<0.001
71888688|NCT00510276|143298365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.94|-2.15|||Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.15|-5.94|<0.001
71888689|NCT00510276|143298366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.02|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.||-0.04|-0.45|0.020
71771138|NCT01155479|143042163|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.4||||0.6378|TWO_SIDED|95.0|-1.29|2.11|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||2.11|-1.29|0.6378
71728105|NCT02752958|142970999|OTHER||Mean Difference (Final Values)|4.39|||<|0.0001|TWO_SIDED|95.0|3.21|5.568|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||5.568|3.210|<0.0001
71728106|NCT02752958|142971000|OTHER||Mean Difference (Final Values)|4.3|||<|0.0001|TWO_SIDED|95.0|3.119|5.477|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||5.477|3.119|<0.0001
71728107|NCT02752958|142971001|OTHER||Mean Difference (Final Values)|2.42||||0.0145|TWO_SIDED|95.0|0.483|4.352|||ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||4.352|0.483|0.0145
71728108|NCT02752958|142971002|OTHER||Mean Difference (Final Values)|4.42|||<|0.0001|TWO_SIDED|95.0|2.498|6.339|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||6.339|2.498|<0.0001
71728109|NCT02752958|142971003|OTHER||Mean Difference (Final Values)|6.85|||<|0.0001|TWO_SIDED|95.0|4.933|8.759|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||8.759|4.933|<0.0001
71728110|NCT02752958|142971004|OTHER||Mean Difference (Final Values)|7.17|||<|0.0001|TWO_SIDED|95.0|5.219|9.115|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||9.115|5.219|<.0001
71728111|NCT02752958|142971005|OTHER||Mean Difference (Final Values)|8.39|||<|0.0001|TWO_SIDED|95.0|6.438|10.335|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||10.335|6.438|<0.0001
71728112|NCT02752958|142971006|OTHER||Mean Difference (Final Values)|8.67|||<|0.0001|TWO_SIDED|95.0|6.726|10.623|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 24||10.623|6.726|<0.0001
71888690|NCT00510276|143298367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.282|TWO_SIDED|95.0|-1.19|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.19|0.282
71728113|NCT02752958|142971007|OTHER||Mean Difference (Final Values)|0.63||||0.3676|TWO_SIDED|95.0|-0.738|1.989|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.989|-0.738|0.3676
71728114|NCT02752958|142971008|OTHER||Mean Difference (Final Values)|0.9||||0.1907|TWO_SIDED|95.0|-0.451|2.255|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8||2.255|-0.451|0.1907
71728115|NCT02752958|142971009|OTHER||Mean Difference (Final Values)|1.81||||0.0085|TWO_SIDED|95.0|0.467|3.162|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12||3.162|0.467|0.0085
71771139|NCT01155479|143042163|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.3||||0.6923|TWO_SIDED|95.0|-1.35|2.03|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||2.03|-1.35|0.6923
71771140|NCT01155479|143042164|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-9.7||||0.0785|TWO_SIDED|95.0|-21.0|1.82||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.82|-21.0|0.0785
71771141|NCT01155479|143042164|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-6.3||||0.2735|TWO_SIDED|95.0|-17.6|5.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||5.05|-17.6|0.2735
71771142|NCT01155479|143042164|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-3.7||||0.4823|TWO_SIDED|95.0|-15.2|7.99||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||7.99|-15.2|0.4823
71888691|NCT00510276|143298368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.556|TWO_SIDED|95.0|-2.21|1.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||1.19|-2.21|0.556
71728116|NCT02752958|142971010|OTHER||Mean Difference (Final Values)|2.12||||0.0026|TWO_SIDED|95.0|0.744|3.489|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||3.489|0.744|0.0026
71728117|NCT02752958|142971011|OTHER||Mean Difference (Final Values)|2.74||||0.0001|TWO_SIDED|95.0|1.371|4.116|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.||Week 0 Vs Week 20||4.116|1.371|0.0001
71728118|NCT02752958|142971012|OTHER||Mean Difference (Final Values)|2.85|||<|0.0001|TWO_SIDED|95.0|1.477|4.222|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 24||4.222|1.477|<.0001
71728119|NCT02752958|142971013|OTHER||Mean Difference (Final Values)|0.09||||0.2326|TWO_SIDED|95.0|-0.059|0.243|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 4||0.243|-0.059|0.2326
71728120|NCT02752958|142971014|OTHER||Mean Difference (Final Values)|0.07||||0.3934|TWO_SIDED|95.0|-0.085|0.216||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||0.216|-0.085|0.3934
71728121|NCT02752958|142971015|OTHER||Mean Difference (Final Values)|0.13||||0.0795|TWO_SIDED|95.0|-0.016|0.284|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||0.284|-0.016|0.0795
71728122|NCT02752958|142971016|OTHER||Mean Difference (Final Values)|0.14||||0.0682|TWO_SIDED|95.0|-0.011|0.294|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16||0.294|-0.011|0.0682
71728123|NCT02752958|142971017|OTHER||Mean Difference (Final Values)|0.13||||0.0844|TWO_SIDED|95.0|-0.018|0.287|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||0.287|-0.018|0.0844
71728124|NCT02752958|142971018|OTHER||Mean Difference (Final Values)|0.18||||0.0211|TWO_SIDED|95.0|0.027|0.332|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 24||0.332|0.027|0.0211
71728125|NCT02752958|142971019|OTHER||Mean Difference (Final Values)|0.6||||0.0493|TWO_SIDED|95.0|0.002|1.194|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||1.194|0.002|0.0493
71728126|NCT02752958|142971020|OTHER||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|0.83|2.013|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||2.013|0.830|<0.0001
71728127|NCT02752958|142971021|OTHER||Mean Difference (Final Values)|1.87|||<|0.0001|TWO_SIDED|95.0|1.278|2.457||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.457|1.278|<0.0001
71728128|NCT02752958|142971022|OTHER||Mean Difference (Final Values)|2.03|||<|0.0001|TWO_SIDED|95.0|1.429|2.629|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16||2.629|1.429|<.0001
71728129|NCT02752958|142971023|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20||2.943|1.743|<.0001
71728130|NCT02752958|142971024|OTHER||Mean Difference (Final Values)|2.34|||<|0.0001|TWO_SIDED|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.943|1.743|<.0001
71728131|NCT02752958|142971025|OTHER||Mean Difference (Final Values)|0.88|||<|0.0001|TWO_SIDED|95.0|0.474|1.295|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.295|0.474|<.0001
71728132|NCT02752958|142971026|OTHER||Mean Difference (Final Values)|1.28|||<|0.0001|TWO_SIDED|95.0|0.875|1.69|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.690|0.875|<.0001
71771143|NCT01155479|143042164|SUPERIORITY_OR_OTHER||Difference vs Placebo (%)|-2.3||||0.6827|TWO_SIDED|95.0|-13.9|9.24||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Rasagiline (Part 1) vs Placebo (Part 1)||9.24|-13.9|0.6827
71771144|NCT01155479|143042165|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.7||||0.0235|TWO_SIDED|95.0|0.09|1.27|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)||1.27|0.09|0.0235
71728133|NCT02752958|142971027|OTHER||Mean Difference (Final Values)|1.74|||<|0.0001|TWO_SIDED|95.0|1.333|2.145|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12||2.145|1.333|<.0001
71728134|NCT02752958|142971028|OTHER||Mean Difference (Final Values)|1.96|||<|0.0001|TWO_SIDED|95.0|1.545|2.371|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16||2.371|1.545|<.0001
71728135|NCT02752958|142971029|OTHER||Mean Difference (Final Values)|2.06|||<|0.0001|TWO_SIDED|95.0|1.643|2.469|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.469|1.643|<.0001
71728136|NCT02752958|142971030|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.794|2.62||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.620|1.794|<.0001
71728137|NCT02752958|142971031|OTHER||Mean Difference (Final Values)|1.18|||<|0.0001|TWO_SIDED|95.0|0.703|1.66|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4||1.660|0.703|<0.0001
71728138|NCT02752958|142971032|OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.977|1.926|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8||1.926|0.977|<.0001
71728139|NCT02752958|142971033|OTHER||Mean Difference (Final Values)|1.95|||<|0.0001|TWO_SIDED|95.0|1.473|2.418|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 12||2.418|1.473|<.0001
71728140|NCT02752958|142971034|OTHER||Mean Difference (Final Values)|2.33|||<|0.0001|TWO_SIDED|95.0|1.848|2.81|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week16||2.810|1.848|<.0001
71728141|NCT02752958|142971035|OTHER||Mean Difference (Final Values)|2.21|||<|0.0001|TWO_SIDED|95.0|1.732|2.694|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20||2.694|1.732|<.0001
71771145|NCT01155479|143042165|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.5||||0.1093|TWO_SIDED|95.0|-0.11|1.04|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)||1.04|-0.11|0.1093
71888692|NCT00510276|143298369|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Pearson's Correlation Coefficient|||Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.||||<0.001
71728142|NCT02752958|142971036|OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.02|2.982|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24||2.982|2.020|<.0001
71728143|NCT02752958|142971037|OTHER||Mean Difference (Final Values)|0.43||||0.0786|TWO_SIDED|95.0|-0.05|0.919|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4||0.919|-0.050|0.0786
71728144|NCT02752958|142971038|OTHER||Mean Difference (Final Values)|0.69||||0.005|TWO_SIDED|95.0|0.21|1.171|||ANOVA|\[1\] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8||1.171|0.210|0.0050
71728145|NCT02752958|142971039|OTHER||Mean Difference (Final Values)|1.4|||<|0.0001|TWO_SIDED|95.0|0.918|1.875|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 12||1.875|0.918|<.0001
71771146|NCT01155479|143042165|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.5756|TWO_SIDED|95.0|-0.42|0.75|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)||0.75|-0.42|0.5756
71888693|NCT00510276|143298370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.198|TWO_SIDED|95.0|-0.39|0.08|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.08|-0.39|0.198
71728146|NCT02752958|142971040|OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.951|1.926|||ANOVA|\[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||1.926|0.951|<.0001
71728147|NCT02752958|142971041|OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.678|1.653||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20||1.653|0.678|<.0001
71728148|NCT02752958|142971042|OTHER||Mean Difference (Final Values)|1.56|||<|0.0001|TWO_SIDED|95.0|1.072|2.047|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit\*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|||2.047|1.072|<.0001
71728149|NCT00977938|142971068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.59|0.85||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.85|0.59|<0.001
71728150|NCT00977938|142971069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.17|0.48||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg-Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.||0.48|0.17|<0.001
71728151|NCT00977938|142971070|NON_INFERIORITY_OR_EQUIVALENCE|The primary safety analysis was a noninferiority analysis performed with the use of the Farrington-Manning risk-difference approach. Assuming an annualized rate for moderate or severe bleeding of 1.9% and an absolute noninferiority margin of 0.8%, at a one-sided alpha level of significance of 0.025, we calculated that a sample size of 9960 patients would give the study 80% power to detect noninferiority.|Risk Difference (RD)|0.96||||0.704|TWO_SIDED|95.0|0.38|1.53||One-sided P-value for non-inferiority|Farrington-Manning||30-month DAPT vs. 12-month DAPT|||1.53|0.38|0.704
71728152|NCT00977938|142971071|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.28% (0.0228)|Risk Difference (RD)|-1.82|||<|0.001|ONE_SIDED|97.5||0.03||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||0.03||<0.001
71728153|NCT00977938|142971072|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.97% (0.0097)|Risk Difference (RD)|-1.05|||<|0.001|ONE_SIDED|97.5||-0.27||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.||-0.27||<0.001
71728154|NCT00977938|142971073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.7|0.97|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.97|0.70|
71888694|NCT00510276|143298371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.825|TWO_SIDED|95.0|-0.33|0.26|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.26|-0.33|0.825
71728155|NCT00977938|142971074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.29|0.69|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||0.69|0.29|
71728156|NCT00977938|142971075|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.86|||||TWO_SIDED|95.0|0.24|1.48|||||30-month DAPT vs. 12-month DAPT|||1.48|0.24|
71771147|NCT01155479|143042165|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.6657|TWO_SIDED|95.0|-0.45|0.7|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)||0.70|-0.45|0.6657
71888695|NCT00510276|143298373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.233|TWO_SIDED|95.0|-0.53|2.17|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||2.17|-0.53|0.233
71888696|NCT00510276|143298374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.676|TWO_SIDED|95.0|-0.24|0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.37|-0.24|0.676
71888697|NCT00510276|143298375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.382|TWO_SIDED|95.0|-1.0|0.39|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.39|-1.00|0.382
71728157|NCT00977938|142971076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.722|TWO_SIDED|95.0|0.57|1.47||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.47|0.57|0.722
71728158|NCT00977938|142971077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.478|TWO_SIDED|95.0|0.15|1.64||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.||1.64|0.15|0.478
71728159|NCT00977938|142971078|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.12||||0.706|TWO_SIDED|95.0|-0.06|2.31|||Farrington-Manning|No formal hypothesis testing was done.|30-month DAPT vs. 12-month DAPT|||2.31|-0.06|0.706
71728160|NCT00977938|142971079|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.58|1.4|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis|||1.40|0.58|
71728161|NCT00977938|142971080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.15|1.64|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|||1.64|0.15|
71728162|NCT00977938|142971081|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.03|||||TWO_SIDED|95.0|-0.21|2.28|||||30-month DAPT vs. 12-month DAPT|||2.28|-0.21|
71728163|NCT03373890|142971090|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71728164|NCT03373890|142971091|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71728165|NCT03373890|142971092|OTHER|Independent samples Mann Whitney U||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||.03
71728166|NCT03373890|142971093|OTHER|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71728167|NCT03373890|142971094|OTHER|Independent samples Mann Whitney U||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71728168|NCT03373890|142971095|OTHER|Independent samples Mann Whitney U||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||.99
71728169|NCT03373890|142971096|OTHER|LInear mixed model||||||0.008|||||||Regression, Logistic|||||||.008
71728170|NCT03373890|142971097|OTHER|Linear mixed model regression||||||0.34|||||||Regression, Linear|||||||.34
71728171|NCT00884039|142971209|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
71728172|NCT02182440|142971212|SUPERIORITY||Difference in LS means|-16.53|STANDARD_ERROR_OF_MEAN|19.243||0.949|TWO_SIDED|95.0|-62.57|29.5|||ANOVA|||Analysis for Part 1||29.50|-62.57|0.949
71728173|NCT02182440|142971212|SUPERIORITY||Difference in LS means|-4.65|STANDARD_ERROR_OF_MEAN|9.305||0.691|TWO_SIDED|95.0|-23.09|13.8|||ANOVA|||Analysis for Part 2||13.80|-23.09|0.691
71728174|NCT02182440|142971212|SUPERIORITY||Combined p-value|0.896||||0.896|TWO_SIDED||||||Inverse normal method||The p-values from Part 1 (see Statistical Analysis 1) and Part 2 (see Statistical Analysis 2) were combined to an overall p-value using the inverse normal method.|Combination of analysis results from Part 1 (see statistical Analysis 1) and Part 2 (see Statistical analysis 2)||||0.896
71728175|NCT02182440|142971213|SUPERIORITY||Odds Ratio (OR)|1.4||||0.28|TWO_SIDED|95.0|0.8|2.4|||Chi-squared|||||2.4|0.8|0.28
71728176|NCT02182440|142971214|SUPERIORITY||Mean Difference (Net)|0.12||||0.02|TWO_SIDED|95.0|0.02|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.02|0.02
71728177|NCT02182440|142971215|SUPERIORITY||Mean Difference (Net)|0.12||||0.03|TWO_SIDED|95.0|0.01|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.01|0.03
71728178|NCT02182440|142971216|SUPERIORITY||Hazard Ratio (HR)|1.77||||0.045|TWO_SIDED|95.0|1.0|3.1|||Regression, Logistic|||||3.1|1.0|0.045
71728179|NCT02182440|142971217|SUPERIORITY||Hazard Ratio (HR)|1.85||||0.03|TWO_SIDED|95.0|1.06|3.26|||Regression, Logistic|||||3.26|1.06|0.03
71771148|NCT00998764|143042171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.324|TWO_SIDED|95.0|-0.74|2.23|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13||2.23|-0.74|0.324
71888698|NCT00510276|143298376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.656|TWO_SIDED|95.0|-1.24|0.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.78|-1.24|0.656
71888699|NCT00510276|143298377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.201|TWO_SIDED|95.0|-4.08|0.86|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.86|-4.08|0.201
71728180|NCT00072293|142971218|NON_INFERIORITY_OR_EQUIVALENCE|As originally designed, target accrual was 1960 patients with analysis planned after 558 events. These targets were based on having 90% power to detect non-inferiority of no axillary dissection with a one-sided statistical signifi cance level of 10% (ie, α=0·10) under the assumption that 5-year disease-free survival with axillary dissection was 70% and defining non-inferiority as a hazard ratio (HR) of less than 1·25 (no axillary dissection relative to axillary dissection).|Hazard Ratio (HR)|0.78||||0.004|TWO_SIDED|95.0|0.55|1.11||Test for non-inferiority of no axillary dissection. Stratified logrank test compared groups. HR (no-AD vs AD) estimated from test statistic and variance as HR=exp(\[O-E\]/V), compared to 1.25 in 1-sided test of non-inferiority.|1-sided non-inferiority test||Hazard Ratio is no axillary dissection/axillary dissection.|||1.11|0.55|0.004
71728181|NCT00072293|142971219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.73|TWO_SIDED|90.0|0.52|1.54|||Log Rank||Hazard Ratio is no axillary dissection/axillary dissection.|||1.54|0.52|0.73
71728182|NCT00355342|142971264|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|0.06|1.49|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status.|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|1.49|0.06|
71728183|NCT00355342|142971265|EQUIVALENCE|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.78|0.24|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment\*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, \<7, \>=7). Slope estimates based on treatment\*time via repeated measures model with unstructured covariance.|0.24|-0.78|
71728184|NCT00953680|142971308|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.993||||||90.0|0.95|1.039||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.039|0.950|
71728185|NCT00953680|142971309|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.835||||||90.0|0.749|0.931||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100-mg tablet + HCTZ 12.5 mg capsule||0.931|0.749|
71728186|NCT00953680|142971310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.924||||||90.0|0.825|1.035||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.035|0.825|
71728187|NCT00953680|142971311|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.931||||||90.0|0.836|1.037||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule||1.037|0.836|
71728188|NCT04545047|142971379|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.3|3.6||||||The investigators estimated the 30-day mortality risk difference comparing patients assigned to each group. Adjustment for covariates would be carried out via inverse probability weighting.||3.60|-2.30|
71831081|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7747|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7747
71728189|NCT04545047|142971379|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.64|1.62||||||The investigators estimated the 30-day mortality hazard ratio comparing patients assigned to each group. The hazard ratio was estimated from pooled logistic models with inverse probability weighting to adjust for confounding.||1.62|0.64|
71728190|NCT01514240|142971385|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than -10% in FAS Population.|Difference of proportion|5.4||||0.526|TWO_SIDED|90.0|-8.49|18.94|||Chi-squared|||The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.||18.94|-8.49|0.526
71728191|NCT01514240|142971386|SUPERIORITY_OR_OTHER||Difference of proportion|1.8||||0.768|TWO_SIDED|90.0|-8.54|12.15|||Chi-squared||Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||12.15|-8.54|0.768
71728192|NCT01514240|142971387|SUPERIORITY_OR_OTHER||Difference of proportion|8.9||||0.208|TWO_SIDED|90.0|-2.87|20.58|||Chi-squared||Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction|||20.58|-2.87|0.208
71728193|NCT01514240|142971388|SUPERIORITY_OR_OTHER||LS mean difference between group|-22.8|STANDARD_ERROR_OF_MEAN|11.89||0.058|TWO_SIDED|90.0|-42.55|-3.09|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-3.09|-42.55|0.058
71728194|NCT01514240|142971389|SUPERIORITY_OR_OTHER||LS mean difference between group|-30.0|STANDARD_ERROR_OF_MEAN|12.05||0.014|TWO_SIDED|90.0|-49.95|-9.96|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||-9.96|-49.95|0.014
71728195|NCT01514240|142971390|SUPERIORITY_OR_OTHER||LS mean difference between group|-21.4|STANDARD_ERROR_OF_MEAN|14.53||0.144|TWO_SIDED|90.0|-45.47|2.74|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.74|-45.47|0.144
71728196|NCT01514240|142971394|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
71728197|NCT01514240|142971395|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|1.66|29.61|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||29.61|1.66|
71728198|NCT01514240|142971396|SUPERIORITY_OR_OTHER||Difference of proportions|16.1|||||TWO_SIDED|90.0|0.85|30.29|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||30.29|0.85|
71728199|NCT01514240|142971397|SUPERIORITY_OR_OTHER||Difference of proportions|7.1|||||TWO_SIDED|90.0|-5.67|19.71|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||19.71|-5.67|
71728200|NCT01514240|142971398|SUPERIORITY_OR_OTHER||Difference of proportions|14.3|||||TWO_SIDED|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||27.40|0.50|
71728201|NCT01514240|142971399|SUPERIORITY_OR_OTHER||Difference of proportions|12.5|||||TWO_SIDED|90.0|-2.44|26.68|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.|||26.68|-2.44|
71728202|NCT01514240|142971400|SUPERIORITY_OR_OTHER||LS mean difference between group|10.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|90.0|4.86|16.14|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||16.14|4.86|
71728203|NCT01514240|142971401|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|3.93|||TWO_SIDED|90.0|6.07|19.11|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.11|6.07|
71728204|NCT01514240|142971402|SUPERIORITY_OR_OTHER||LS mean difference between group|12.6|STANDARD_ERROR_OF_MEAN|4.31|||TWO_SIDED|90.0|5.4|19.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||19.72|5.40|
71728205|NCT01514240|142971403|SUPERIORITY_OR_OTHER||LS mean difference between group|14.1|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|90.0|6.9|21.23|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||21.23|6.90|
71728206|NCT01514240|142971404|SUPERIORITY_OR_OTHER||LS mean difference between group|3.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|1.49|5.29|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.29|1.49|
71728207|NCT01514240|142971405|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|1.64|5.97|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.97|1.64|
71728208|NCT01514240|142971406|SUPERIORITY_OR_OTHER||LS mean difference between group|4.1|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|90.0|1.58|6.64|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.64|1.58|
71728209|NCT01514240|142971407|SUPERIORITY_OR_OTHER||LS mean difference between group|3.3|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|0.9|5.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||5.76|0.90|
71728210|NCT01514240|142971408|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|0.89|3.17|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.17|0.89|
71728211|NCT01514240|142971409|SUPERIORITY_OR_OTHER||LS mean difference between group|2.0|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|0.73|3.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.19|0.73|
71728212|NCT01514240|142971410|SUPERIORITY_OR_OTHER||LS mean difference between group|2.4|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.96|3.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.76|0.96|
71728213|NCT01514240|142971411|SUPERIORITY_OR_OTHER||LS mean difference between group|2.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|1.15|4.09|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||4.09|1.15|
71728214|NCT01514240|142971412|SUPERIORITY_OR_OTHER||LS mean difference between group|3.8|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|90.0|1.44|6.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||6.19|1.44|
71888700|NCT00510276|143298378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.06|||<|0.001|TWO_SIDED|95.0|-7.39|-2.72|||Mixed Models Analysis|Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.||Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.||-2.72|-7.39|<0.001
71728215|NCT01514240|142971413|SUPERIORITY_OR_OTHER||LS mean difference between group|4.9|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|2.14|7.65|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.65|2.14|
71728216|NCT01514240|142971414|SUPERIORITY_OR_OTHER||LS mean difference between group|4.3|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|1.4|7.25|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||7.25|1.40|
71728217|NCT01514240|142971415|SUPERIORITY_OR_OTHER||LS mean difference between group|6.6|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|3.56|9.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||9.72|3.56|
71771149|NCT00998764|143042171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.723|TWO_SIDED|95.0|-1.33|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26||1.92|-1.33|0.723
71771150|NCT00998764|143042171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.966|TWO_SIDED|95.0|-1.81|1.89|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39||1.89|-1.81|0.966
71831082|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7305|TWO_SIDED|95.0|-0.32|0.22|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.32|0.7305
71831083|NCT02528188|143167424|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.733|TWO_SIDED|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.||0.32|-0.22|0.7330
71831084|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2159|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2159
71888701|NCT00510276|143298379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.933|TWO_SIDED|95.0|-16.41|17.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||17.63|-16.41|0.933
71888702|NCT00510276|143298380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95||||0.007|TWO_SIDED|95.0|-5.09|-0.81|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.81|-5.09|0.007
71728218|NCT01514240|142971416|SUPERIORITY_OR_OTHER||LS mean difference between group|1.2|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.01|2.43|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.43|0.01|
71831085|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2049|TWO_SIDED|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.10|0.2049
71888703|NCT00510276|143298381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.219|TWO_SIDED|95.0|-1.5|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.35|-1.50|0.219
71728219|NCT01514240|142971417|SUPERIORITY_OR_OTHER||LS mean difference between group|1.8|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|90.0|0.42|3.12|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.12|0.42|
71728220|NCT01514240|142971418|SUPERIORITY_OR_OTHER||LS mean difference between group|1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|0.19|3.04|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||3.04|0.19|
71771151|NCT00998764|143042171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-1.93|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52||1.92|-1.93|0.996
71658465|NCT01000493|142832082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.5426|TWO_SIDED|95.0|-1.51|2.85||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||2.85|-1.51|0.5426
71658466|NCT01000493|142832082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7552|TWO_SIDED|95.0|-2.73|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||3.75|-2.73|0.7552
71658467|NCT01000493|142832082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.3827|TWO_SIDED|95.0|-7.27|2.83||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||2.83|-7.27|0.3827
71658468|NCT01000493|142832082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98||||0.4915|TWO_SIDED|95.0|-7.71|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.75|-7.71|0.4915
71658469|NCT01000493|142832083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.919|TWO_SIDED|95.0|-1.93|1.74||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||1.74|-1.93|0.9190
71658470|NCT01000493|142832083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.3326|TWO_SIDED|95.0|-1.37|4.0||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||4.00|-1.37|0.3326
71658471|NCT01000493|142832083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9712|TWO_SIDED|95.0|-3.91|3.77||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||3.77|-3.91|0.9712
71658472|NCT01000493|142832083|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.6711|TWO_SIDED|95.0|-5.22|3.39||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.39|-5.22|0.6711
71658473|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.5532|TWO_SIDED|95.0|0.36|6.92||The analysis method was logistic regression adjusted for Baseline total Clinical Global Impression-Severity of Illness scales (CGI-S) score.|Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||6.92|0.36|0.5532
71658474|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.4508|TWO_SIDED|95.0|0.54|3.93|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||3.93|0.54|0.4508
71658475|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9234|TWO_SIDED|95.0|0.42|2.62|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||2.62|0.42|0.9234
71658476|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.0662|TWO_SIDED|95.0|0.94|6.53|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 1|||6.53|0.94|0.0662
71658477|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.2767|TWO_SIDED|95.0|0.61|5.48|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||5.48|0.61|0.2767
71658478|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17||||0.0588|TWO_SIDED|95.0|0.96|10.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||10.5|0.96|0.0588
71658479|NCT01000493|142832084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33||||0.1032|TWO_SIDED|95.0|0.78|14.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||14.1|0.78|0.1032
71658480|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.1743|TWO_SIDED|95.0|-0.29|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.|||0.05|-0.29|0.1743
71658481|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.1181|TWO_SIDED|95.0|-0.46|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||0.05|-0.46|0.1181
71658482|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.9698|TWO_SIDED|95.0|-0.35|0.34||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.34|-0.35|0.9698
71831086|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.03||0.0002|TWO_SIDED|95.0|-0.19|-0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.19|0.0002
71728221|NCT01514240|142971419|SUPERIORITY_OR_OTHER||LS mean difference between group|1.3|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.15|2.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.|||2.76|-0.15|
71728222|NCT00450294|142971420|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
71728223|NCT00450294|142971421|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.||||<0.001
71728224|NCT01103063|142971422|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|STANDARD_DEVIATION|0.0647||0.12237|TWO_SIDED|95.0|0.97|1.25||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.25|0.97|0.12237
71728225|NCT01103063|142971423|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.1243||0.84117|TWO_SIDED|95.0|0.8|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.80|0.84117
71728226|NCT01103063|142971424|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_DEVIATION|0.1745||0.4428|TWO_SIDED|95.0|0.62|1.23||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.23|0.62|0.4428
71728227|NCT01103063|142971425|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|STANDARD_DEVIATION|0.1882||0.6086|TWO_SIDED|95.0|0.63|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.31|0.63|0.6086
71728228|NCT01103063|142971426|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2866||0.7035|TWO_SIDED|95.0|0.51|1.57||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.57|0.51|0.7035
71728229|NCT01103063|142971427|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|STANDARD_DEVIATION|0.04||0.4605|TWO_SIDED|95.0|0.95|1.11||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.11|0.95|0.4605
71728230|NCT01103063|142971428|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|0.1817||0.7105|TWO_SIDED|95.0|0.65|1.33||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.33|0.65|0.7105
71728231|NCT01103063|142971429|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.1842||0.3468|TWO_SIDED|95.0|0.59|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.59|0.3468
71831087|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.21|-0.08|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.08|-0.21|<0.0001
71658483|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1341|TWO_SIDED|95.0|-0.69|0.09||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||0.09|-0.69|0.1341
71658484|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.0064|TWO_SIDED|95.0|-1.04|-0.18||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||-0.18|-1.04|0.0064
71771152|NCT00998764|143042171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.336|TWO_SIDED|95.0|-3.67|1.26|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78||1.26|-3.67|0.336
71771153|NCT00998764|143042172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.737|TWO_SIDED|95.0|-1.11|0.79|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 13||0.79|-1.11|0.737
71771154|NCT00998764|143042172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.213|TWO_SIDED|95.0|-1.76|0.4|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 26||0.40|-1.76|0.213
71771155|NCT00998764|143042172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.168|TWO_SIDED|95.0|-2.19|0.38|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 39||0.38|-2.19|0.168
71771156|NCT00998764|143042172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.197|TWO_SIDED|95.0|-2.3|0.48|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 52||0.48|-2.30|0.197
71771157|NCT00998764|143042172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.044|TWO_SIDED|95.0|-4.21|0.06|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 78||0.06|-4.21|0.044
71771158|NCT00998764|143042173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.077|TWO_SIDED|95.0|-6.3|0.33|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 13||0.33|-6.30|0.077
71771159|NCT00998764|143042173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.117|TWO_SIDED|95.0|-6.02|0.67|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 26||0.67|-6.02|0.117
71658485|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.1095|TWO_SIDED|95.0|-0.98|0.1||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.10|-0.98|0.1095
71658486|NCT01000493|142832085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2814|TWO_SIDED|95.0|-0.9|0.27||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||0.27|-0.90|0.2814
71771160|NCT00998764|143042173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.063|TWO_SIDED|95.0|-7.38|0.19|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 39||0.19|-7.38|0.063
71771161|NCT00998764|143042173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.412|TWO_SIDED|95.0|-5.95|2.44|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 52||2.44|-5.95|0.412
71771162|NCT00998764|143042173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78||||0.321|TWO_SIDED|95.0|-8.28|2.73|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 78||2.73|-8.28|0.321
71771163|NCT00998764|143042174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.329|TWO_SIDED|95.0|-3.24|1.09|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 13||1.09|-3.24|0.329
71658487|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92||||0.0083|TWO_SIDED|95.0|-3.33|-0.5||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1|||-0.50|-3.33|0.0083
71658488|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94||||0.0311|TWO_SIDED|95.0|-3.71|-0.18||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.|||-0.18|-3.71|0.0311
71658489|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.1155|TWO_SIDED|95.0|-4.26|0.47||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.|||0.47|-4.26|0.1155
71771164|NCT00998764|143042174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.601|TWO_SIDED|95.0|-3.31|1.92|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 26||1.92|-3.31|0.601
71771165|NCT00998764|143042174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.328|TWO_SIDED|95.0|-4.67|1.56|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 39||1.56|-4.67|0.328
71771166|NCT00998764|143042174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.68|TWO_SIDED|95.0|-2.7|4.13|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 52||4.13|-2.70|0.680
71771167|NCT00998764|143042174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.954|TWO_SIDED|95.0|-5.05|4.77|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 78||4.77|-5.05|0.954
71771168|NCT00998764|143042175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.931|TWO_SIDED|95.0|-2.4|2.62|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 26.||2.62|-2.40|0.931
71771169|NCT00998764|143042175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.524|TWO_SIDED|95.0|-3.26|1.67|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 52.||1.67|-3.26|0.524
71771170|NCT00998764|143042175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.353|TWO_SIDED|95.0|-6.32|2.27|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 78.||2.27|-6.32|0.353
71771171|NCT00998764|143042176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.531|TWO_SIDED|95.0|-2.92|1.51|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 26.||1.51|-2.92|0.531
71771172|NCT00998764|143042176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.137|TWO_SIDED|95.0|-4.28|0.59|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 52.||0.59|-4.28|0.137
71728232|NCT01103063|142971430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0011|TWO_SIDED|95.0|-0.08|-0.02||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.02|-0.08|0.0011
71888704|NCT00510276|143298382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.58||||0.002|TWO_SIDED|95.0|-12.37|-2.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-2.78|-12.37|0.002
71888705|NCT00510276|143298383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.644|TWO_SIDED|95.0|-0.47|0.29|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.29|-0.47|0.644
71888706|NCT00510276|143298384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.097|TWO_SIDED|95.0|-0.02|0.25|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.25|-0.02|0.097
71728233|NCT01103063|142971431|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|STANDARD_DEVIATION|0.0604||0.2265|TWO_SIDED|95.0|0.96|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.21|0.96|0.2265
71728234|NCT01103063|142971432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0131|TWO_SIDED|95.0|-0.24|-0.03||Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable.|ANCOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.03|-0.24|0.0131
71728235|NCT01103063|142971433|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|STANDARD_DEVIATION|0.2694||0.6978|TWO_SIDED|95.0|0.53|1.53||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.53|0.53|0.6978
71728236|NCT01103063|142971434|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|STANDARD_DEVIATION|0.2908||0.6542|TWO_SIDED|95.0|0.64|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.64|0.6542
71728237|NCT01103063|142971435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|19.71||0.9145|TWO_SIDED|95.0|-36.5|40.8||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable.|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||40.8|-36.5|0.9145
71728238|NCT01103063|142971436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.||-0.04|-0.09|<0.0001
71728239|NCT01103063|142971437|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|STANDARD_DEVIATION|0.1221|<|0.0001|TWO_SIDED|95.0|0.38|0.62||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.62|0.38|<0.0001
71728240|NCT01103063|142971438|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|STANDARD_DEVIATION|0.2295||0.036|TWO_SIDED|95.0|0.39|0.97||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.97|0.39|0.0360
71728241|NCT01103063|142971439|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_DEVIATION|0.163||0.1975|TWO_SIDED|95.0|0.59|1.12||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.12|0.59|0.1975
71771173|NCT00998764|143042176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.128|TWO_SIDED|95.0|-7.6|0.96|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 78.||0.96|-7.60|0.128
71888707|NCT00510276|143298385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.002|TWO_SIDED|95.0|-1.57|-0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.37|-1.57|0.002
71728242|NCT01103063|142971440|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|STANDARD_DEVIATION|0.5675||0.4655|TWO_SIDED|95.0|0.22|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||2.01|0.22|0.4655
71728243|NCT01103063|142971441|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|STANDARD_DEVIATION|0.0918||0.0016|TWO_SIDED|95.0|0.62|0.9||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.90|0.62|0.0016
71728244|NCT01103063|142971442|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.34|STANDARD_DEVIATION|0.5338||0.1113|TWO_SIDED|95.0|0.82|6.66||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||6.66|0.82|0.1113
71728245|NCT01103063|142971443|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.25|STANDARD_DEVIATION|0.6386||0.0284|TWO_SIDED|95.0|0.07|0.86||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.86|0.07|0.0284
71728246|NCT01103063|142971444|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.3291||0.0188|TWO_SIDED|95.0|0.24|0.88||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.88|0.24|0.0188
71728247|NCT01103063|142971445|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|STANDARD_DEVIATION|0.1336||0.0527|TWO_SIDED|95.0|0.59|1.0||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.00|0.59|0.0527
71728248|NCT01103063|142971446|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.1536||0.0384|TWO_SIDED|95.0|0.54|0.98||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.98|0.54|0.0384
71728249|NCT01103063|142971447|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|STANDARD_DEVIATION|0.8648||0.3942|TWO_SIDED|95.0|0.38|11.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||11.38|0.38|0.3942
71728250|NCT01103063|142971448|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39|STANDARD_DEVIATION|0.4439||0.0332|TWO_SIDED|95.0|0.16|0.93||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||0.93|0.16|0.0332
71888708|NCT00510276|143298386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.044|TWO_SIDED|95.0|-1.33|-0.02|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.02|-1.33|0.044
71771174|NCT00998764|143042177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.811|TWO_SIDED|95.0|-0.49|0.63|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 6.||0.63|-0.49|0.811
71771175|NCT00998764|143042177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.681|TWO_SIDED|95.0|-0.45|0.69|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 19.||0.69|-0.45|0.681
71658490|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.89||||0.021|TWO_SIDED|95.0|-5.33|-0.45||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.|||-0.45|-5.33|0.0210
71771176|NCT00998764|143042177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.742|TWO_SIDED|95.0|-0.51|0.72|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||0.72|-0.51|0.742
71888709|NCT00510276|143298387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49||||0.003|TWO_SIDED|95.0|-7.43|-1.55|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-1.55|-7.43|0.003
71728251|NCT01103063|142971449|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61|STANDARD_DEVIATION|0.4195||0.2321|TWO_SIDED|95.0|0.27|1.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.||1.38|0.27|0.2321
71728252|NCT01103063|142971450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.76||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
71728253|NCT01103063|142971450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
71728254|NCT01103063|142971451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.||||1.0000
71728255|NCT01103063|142971451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.||||1.0000
71728256|NCT01437098|142971457|SUPERIORITY_OR_OTHER||Proportion of IF Implanted Subjects|91.7|||<|0.001|TWO_SIDED|95.0|77.5|98.2|||Exact binomial|||||98.2|77.5|<0.001
71728257|NCT00252694|142971518|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1994|TWO_SIDED|95.0|0.704|1.076|||Log Rank|Generalized||||1.076|0.704|0.1994
71728258|NCT02868034|142971532|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.025|TWO_SIDED|97.5|-0.26|0.22|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects at 4 weeks||0.22|-0.26|0.025
71728259|NCT02868034|142971532|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.025|TWO_SIDED|97.5|-0.43|0.09|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|SMT Component Main Effects after 12 weeks||0.09|-0.43|0.025
71728260|NCT02868034|142971532|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.025|TWO_SIDED|97.5|-0.11|0.38|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Treatment Component Main Effects at 4 weeks||0.38|-0.11|0.025
71728261|NCT02868034|142971532|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.025|TWO_SIDED|97.5|-0.23|0.29|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.29|-0.23|0.025
71728262|NCT02868034|142971532|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-0.45|0.04|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in stiffness when the component was used|Activating Exercise Component Main Effect at 4 weeks||0.04|-0.45|0.025
71728263|NCT02868034|142971532|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.45|0.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater change when the component was used|Activating Exercise Component Main Effect at 12 weeks||0.07|-0.45|0.025
71728264|NCT02868034|142971532|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||0.32|-0.66|0.025
71728265|NCT02868034|142971532|SUPERIORITY||interaction relative mean difference|-0.1||||0.025|TWO_SIDED|97.5|-0.62|0.42|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||0.42|-0.62|0.025
71728266|NCT02868034|142971532|SUPERIORITY||interaction relative mean difference|0.13||||0.025|TWO_SIDED|97.5|-0.36|0.62|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||0.62|-0.36|0.025
71728267|NCT02868034|142971532|SUPERIORITY||interaction relative mean difference|0.5||||0.025|TWO_SIDED|97.5|-0.02|1.02|||Mixed Models Analysis|||||1.02|-0.02|0.025
71728268|NCT02868034|142971532|SUPERIORITY||interaction relative mean difference|-0.17||||0.025|TWO_SIDED|97.5|-0.66|0.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||0.32|-0.66|0.025
71728269|NCT02868034|142971532|SUPERIORITY||interaction relative mean difference|0.39||||0.025|TWO_SIDED|97.5|-0.13|0.91|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||0.91|-0.13|0.025
71728270|NCT02868034|142971532|SUPERIORITY||3-way interaction relative mean dif.|0.25||||0.025|TWO_SIDED|97.5|-0.24|0.74|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||0.74|-0.24|0.025
71728271|NCT02868034|142971532|SUPERIORITY||3-way interaction relative mean dif.|0.4||||0.025|TWO_SIDED|97.5|-0.12|0.92|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||0.92|-0.12|0.025
71728272|NCT02868034|142971533|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.67|1.52|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.||SMT Component Main Effects at 4 weeks|A positive value indicates greater improvement in muscle activation when the component was used|1.52|-2.67|0.025
71728273|NCT02868034|142971533|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.025|TWO_SIDED|97.5|-2.76|2.02|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|SMT Component Main Effects at 12 weeks||2.02|-2.76|0.025
71771177|NCT00998764|143042177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.598|TWO_SIDED|95.0|-0.48|0.83|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||0.83|-0.48|0.598
71728274|NCT02868034|142971533|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.025|TWO_SIDED|97.5|-2.03|2.16|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 4 weeks||2.16|-2.03|0.025
71728275|NCT02868034|142971533|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.025|TWO_SIDED|97.5|-1.68|3.11|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Mobilizing Component Main Effects at 12 weeks||3.11|-1.68|0.025
71728276|NCT02868034|142971533|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.025|TWO_SIDED|97.5|-2.94|1.25|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 4 weeks||1.25|-2.94|0.025
71728277|NCT02868034|142971533|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.025|TWO_SIDED|97.5|-2.97|1.82|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A positive value indicates greater improvement in muscle activation when the component was used|Activating Exercise Component at 12 weeks||1.82|-2.97|0.025
71728278|NCT02868034|142971533|SUPERIORITY||interaction relative mean difference|0.8||||0.025|TWO_SIDED|97.5|-3.39|4.99|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||4.99|-3.39|0.025
71728279|NCT02868034|142971533|SUPERIORITY||interaction relative mean difference|-0.68||||0.025|TWO_SIDED|97.5|-5.47|4.11|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||4.11|-5.47|0.025
71728280|NCT02868034|142971533|SUPERIORITY||interaction relative mean difference|-1.56||||0.025|TWO_SIDED|97.5|-5.75|2.63|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||2.63|-5.75|0.025
71728281|NCT02868034|142971533|SUPERIORITY||interaction relative mean difference|1.42||||0.025|TWO_SIDED|97.5|-3.37|6.21|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||6.21|-3.37|0.025
71728282|NCT02868034|142971533|SUPERIORITY||interaction relative mean difference|-0.44||||0.025|TWO_SIDED|97.5|-4.63|3.75|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||3.75|-4.63|0.025
71728283|NCT02868034|142971533|SUPERIORITY||interaction relative mean difference|2.01||||0.025|TWO_SIDED|97.5|-2.77|6.8|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||6.80|-2.77|0.025
71658491|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0582|TWO_SIDED|95.0|-5.83|0.1||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.|||0.10|-5.83|0.0582
71728284|NCT02868034|142971533|SUPERIORITY||3-way interaction relative mean dif.|-0.18||||0.025|TWO_SIDED|97.5|-4.37|4.01|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.01|-4.37|0.025
71728285|NCT02868034|142971533|SUPERIORITY||3-way interaction relative mean dif.|0.56||||0.025|TWO_SIDED|97.5|-4.22|5.35|||Mixed Models Analysis|||Three-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||5.35|-4.22|0.025
71728286|NCT02868034|142971534|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.025|TWO_SIDED|97.5|-4.0|1.68|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 4-weeks||1.68|-4.0|0.025
71728287|NCT02868034|142971534|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.025|TWO_SIDED|97.5|-3.46|3.07|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|SMT Treatment Component Main Effect at 12-weeks||3.07|-3.46|0.025
71728288|NCT02868034|142971534|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.025|TWO_SIDED|97.5|-4.2|1.48|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 4-weeks||1.48|-4.2|0.025
71728289|NCT02868034|142971534|SUPERIORITY||Mean Difference (Final Values)|-1.72||||0.025|TWO_SIDED|97.5|-4.99|1.55|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Mobilizing Exercise Treatment Component main effect after 12-weeks||1.55|-4.99|0.025
71728290|NCT02868034|142971534|SUPERIORITY||Mean Difference (Final Values)|-2.34||||0.025|TWO_SIDED|97.5|-5.18|0.5|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Exercise Treatment Component main effect after 4-weeks||0.50|-5.18|0.025
71728291|NCT02868034|142971534|SUPERIORITY||Mean Difference (Final Values)|-3.62||||0.025|TWO_SIDED|97.5|-6.89|-0.35|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater improvement in disability when the component was used|Activating Treatment Component Main Effect after 12-weeks||-0.35|-6.89|0.025
71728292|NCT02868034|142971534|SUPERIORITY||interaction relative mean difference|3.24||||0.025|TWO_SIDED|97.5|-2.45|8.92|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||8.92|-2.45|0.025
71728293|NCT02868034|142971534|SUPERIORITY||interaction relative mean difference|4.34||||0.025|TWO_SIDED|97.5|-2.19|10.87|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||10.87|-2.19|0.025
71888710|NCT00510276|143298388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.456|TWO_SIDED|95.0|-0.51|0.23|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.23|-0.51|0.456
71728294|NCT02868034|142971534|SUPERIORITY||interaction relative mean difference|0.57||||0.025|TWO_SIDED|97.5|-5.12|6.25|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||6.25|-5.12|0.025
71728295|NCT02868034|142971534|SUPERIORITY||interaction relative mean difference|-0.67||||0.025|TWO_SIDED|97.5|-7.2|5.87|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||5.87|-7.20|0.025
71728296|NCT02868034|142971534|SUPERIORITY||interaction relative mean difference|4.64||||0.025|TWO_SIDED|97.5|-1.04|10.32|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 4 weeks||10.32|-1.04|0.025
71728297|NCT02868034|142971534|SUPERIORITY||interaction relative mean difference|1.49||||0.025|TWO_SIDED|97.5|-5.04|8.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||8.02|-5.04|0.025
71728298|NCT02868034|142971534|SUPERIORITY||3-way interaction relative mean dif.|-0.86||||0.025|TWO_SIDED|97.5|-6.54|4.82|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||4.82|-6.54|0.025
71728299|NCT02868034|142971534|SUPERIORITY||3-way interaction relative mean dif.|0.04||||0.025|TWO_SIDED|97.5|-6.5|6.57|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||6.57|-6.50|0.025
71728300|NCT02868034|142971535|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.025|TWO_SIDED|97.5|-0.6|0.32|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effect at 4-weeks||0.32|-0.60|0.025
71728301|NCT02868034|142971535|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.025|TWO_SIDED|97.5|-0.44|0.61|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|SMT Treatment Component Main Effects at 12 weeks||0.61|-0.44|0.025
71888711|NCT00510276|143298389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.051|TWO_SIDED|95.0|-1.31|0.0|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.00|-1.31|0.051
71728302|NCT02868034|142971535|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.025|TWO_SIDED|97.5|-0.92|0.0|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 4 weeks||0.0|-0.92|0.025
71728303|NCT02868034|142971535|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.025|TWO_SIDED|97.5|-0.7|0.34|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Mobilizing Exercise Component Main Effects at 12 weeks||0.34|-0.70|0.025
71728304|NCT02868034|142971535|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.025|TWO_SIDED|97.5|-0.62|0.3|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 4 weeks||0.30|-0.62|0.025
71728305|NCT02868034|142971535|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.025|TWO_SIDED|97.5|-0.71|0.33|||Mixed Models Analysis|Consistent with the randomized design, mean values for the Phase II baseline were constrained to be equal to a common overall mean.|A negative value indicates greater reduction in pain intensity when the component was used|Activating Exercise Component Main Effects at 12 weeks||0.33|-0.71|0.025
71728306|NCT02868034|142971535|SUPERIORITY||interaction relative mean difference|0.38||||0.025|TWO_SIDED|97.5|-0.54|1.3|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 4 weeks||1.30|-0.54|0.025
71728307|NCT02868034|142971535|SUPERIORITY||interaction relative mean difference|0.45||||0.025|TWO_SIDED|97.5|-0.6|1.49|||Mixed Models Analysis|||Pairwise interaction effect of mobilizing and activating exercise components after 12 weeks||1.49|-0.60|0.025
71728308|NCT02868034|142971535|SUPERIORITY||interaction relative mean difference|0.12||||0.025|TWO_SIDED|97.5|-0.8|1.04|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 4 weeks||1.04|-0.80|0.025
71728309|NCT02868034|142971535|SUPERIORITY||interaction relative mean difference|0.23||||0.025|TWO_SIDED|97.5|-0.81|1.28|||Mixed Models Analysis|||Pairwise interaction effect of SMT and activating exercise components after 12 weeks||1.28|-0.81|0.025
71728310|NCT02868034|142971535|SUPERIORITY||interaction relative mean difference|0.89||||0.025|TWO_SIDED|97.5|-0.03|1.81|||Mixed Models Analysis|||||1.81|-0.03|0.025
71728311|NCT02868034|142971535|SUPERIORITY||interaction relative mean difference|-0.02||||0.025|TWO_SIDED|97.5|-1.07|1.02|||Mixed Models Analysis|||Pairwise interaction effect of SMT and mobilizing exercise components after 12 weeks||1.02|-1.07|0.025
71728312|NCT02868034|142971535|SUPERIORITY||3-way interaction relative mean dif.|0.71||||0.025|TWO_SIDED|97.5|-0.21|1.63|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 4 weeks||1.63|-0.21|0.025
71728313|NCT02868034|142971535|SUPERIORITY||3-way interaction relative mean dif.|0.0||||0.025|TWO_SIDED|97.5|-1.05|1.04|||Mixed Models Analysis|||3-way interaction effect of SMT, activating exercise and mobilizing exercise components after 12 weeks||1.04|-1.05|0.025
71728314|NCT01509677|142971538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7922||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided test at 5% significant level||||0.7922
71728315|NCT01509677|142971538|SUPERIORITY||Risk Ratio (RR)|1.03|STANDARD_ERROR_OF_MEAN|0.12||0.7917|TWO_SIDED|95.0|0.82|1.3|||Poisson regression model|||||1.30|0.82|0.7917
71771178|NCT00998764|143042177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.922|TWO_SIDED|95.0|-0.85|0.77|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||0.77|-0.85|0.922
71771179|NCT00998764|143042178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 6.||0.90|-0.08|0.099
71728316|NCT01509677|142971539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided, 5% test||||0.7145
71728317|NCT01509677|142971540|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.04|STANDARD_ERROR_OF_MEAN|0.119||0.7136|TWO_SIDED|95.0|0.83|1.3|||Poisson regression model|||2-sided 5% test||1.30|0.83|0.7136
71728318|NCT01509677|142971541|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.4|STANDARD_ERROR_OF_MEAN|15.45||0.4606||95.0|-19.2|42.1|||ANCOVA|||2-sided 5% test||42.1|-19.2|0.4606
71728319|NCT01509677|142971542|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19|STANDARD_ERROR_OF_MEAN|0.194||0.2744|TWO_SIDED|95.0|0.87|1.64|||Poisson regression model|||2-sided 5% test||1.64|0.87|0.2744
71728320|NCT01509677|142971543|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|STANDARD_ERROR_OF_MEAN|0.086||0.1128|TWO_SIDED|95.0|0.7|1.04|||Poisson regression model|||2-sided 5% test||1.04|0.70|0.1128
71728321|NCT01509677|142971544|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.93|STANDARD_ERROR_OF_MEAN|0.164||0.674|TWO_SIDED|95.0|0.66|1.31|||Regression, Linear|Poisson regression model||2-sided 5% test||1.31|0.66|0.6740
71771180|NCT00998764|143042178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.089|TWO_SIDED|95.0|-0.07|1.01|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 19.||1.01|-0.07|0.089
71771181|NCT00998764|143042178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.152|TWO_SIDED|95.0|-0.17|1.08|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.||1.08|-0.17|0.152
71771182|NCT00998764|143042178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.16|TWO_SIDED|95.0|-0.21|1.25|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.||1.25|-0.21|0.160
71658492|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88||||0.0927|TWO_SIDED|95.0|-6.25|0.49||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.|||0.49|-6.25|0.0927
71728322|NCT01509677|142971545|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.84|STANDARD_ERROR_OF_MEAN|0.082||0.0677|TWO_SIDED|95.0|0.69|1.01|||Poisson regression model|||2-sided 5% test||1.01|0.69|0.0677
71728323|NCT01509677|142971546|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.82|STANDARD_ERROR_OF_MEAN|0.177||0.3566|TWO_SIDED|95.0|0.54|1.25|||Poisson regression model|||2-sided 5% test||1.25|0.54|0.3566
71728324|NCT01509677|142971547|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6354|STANDARD_ERROR_OF_MEAN|2.30185||0.4794|TWO_SIDED|95.0|-2.9429|6.2137|||ANCOVA|||2 sided 5% test||6.2137|-2.9429|0.4794
71728325|NCT01509677|142971548|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4727|STANDARD_ERROR_OF_MEAN|0.32866||0.1541|TWO_SIDED|95.0|-0.181|1.1264|||ANCOVA|||2 sided 5% test||1.1264|-0.1810|0.1541
71728326|NCT01509677|142971549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0626|STANDARD_ERROR_OF_MEAN|0.03681||0.0927|TWO_SIDED|95.0|-0.1358|0.0106|||ANCOVA|||2 sided 5% test||0.0106|-0.1358|0.0927
71728327|NCT01509677|142971550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0107|STANDARD_ERROR_OF_MEAN|0.01647||0.5175|TWO_SIDED|95.0|-0.0435|0.022|||ANCOVA|||2 sided 5% test||0.0220|-0.0435|0.5175
71728328|NCT01509677|142971551|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.146|STANDARD_ERROR_OF_MEAN|3.3253||0.5205|TWO_SIDED|95.0|-4.466|8.757|||ANCOVA|||2-sided 5 % test||8.757|-4.466|0.5205
71728329|NCT01509677|142971552|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.141|STANDARD_ERROR_OF_MEAN|3.0057||0.7052|TWO_SIDED|95.0|-4.835|7.117|||ANCOVA|||2-sided 5 % test||7.117|-4.835|0.7052
71728330|NCT01509677|142971553|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.867|STANDARD_ERROR_OF_MEAN|0.7331||0.0127|TWO_SIDED|95.0|-3.324|-0.409|||ANCOVA|||2-sided 5 % test||-0.409|-3.324|0.0127
71728331|NCT01509677|142971554|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.1871||0.7862|TWO_SIDED|95.0|-0.423|0.321|||ANCOVA|||2-sided 5 % test||0.321|-0.423|0.7862
71728332|NCT01509677|142971555|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.005||0.8769|TWO_SIDED|95.0|-1.84|2.15|||ANCOVA|||2-sided 5% test||2.15|-1.84|0.8769
71728333|NCT01509677|142971556|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|711.1|STANDARD_ERROR_OF_MEAN|2768.79||0.7978|TWO_SIDED|95.0|-4778.3|6200.5|||ANCOVA|||2-sided 5% test||6200.5|-4778.3|0.7978
71728334|NCT01509677|142971557|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|88.5|STANDARD_ERROR_OF_MEAN|79.26||0.2669|TWO_SIDED|95.0|-68.6|245.6|||ANCOVA|||2-sided 5% test||245.6|-68.6|0.2669
71728335|NCT01509677|142971558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.9|STANDARD_ERROR_OF_MEAN|67.78||0.7033|TWO_SIDED|95.0|-160.3|108.5|||ANCOVA|||2-sided 5% test||108.5|-160.3|0.7033
71728336|NCT01509677|142971559|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.79|STANDARD_ERROR_OF_MEAN|18.039||0.1264|TWO_SIDED|95.0|-7.97|63.55|||ANCOVA|||2-sided 5% test||63.55|-7.97|0.1264
71771183|NCT00998764|143042178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.603|TWO_SIDED|95.0|-0.73|1.26|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.||1.26|-0.73|0.603
71771184|NCT04761627|143042179|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric Least Squares (LS) Means Ratio|0.9325|||||TWO_SIDED|90.0|0.8874|0.9799|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% confidence intervals (CIs) were estimated using the analysis of covariance (ANCOVA) model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||0.9799|0.8874|
71728337|NCT01509677|142971560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|296.8|STANDARD_ERROR_OF_MEAN|124.07||0.0185|TWO_SIDED|95.0|50.9|542.7|||ANCOVA|||2-sided 5% test||542.7|50.9|0.0185
71728338|NCT01509677|142971561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.086||0.9989|TWO_SIDED|95.0|-0.17|0.17|||ANCOVA|||2-sided 5% test||0.17|-0.17|0.9989
71728339|NCT01509677|142971562|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.309||0.6701|TWO_SIDED|95.0|-3.15|2.03|||ANCOVA|||2-sided 5% test||2.03|-3.15|0.6701
71728340|NCT01509677|142971563|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1105|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA|||2-sided 5% test||3.9|-0.4|0.1105
71728341|NCT01509677|142971564|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|15.62||0.9261|TWO_SIDED|95.0|-32.4|29.5|||ANCOVA|||2-sided 5% test||29.5|-32.4|0.9261
71771185|NCT04761627|143042180|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9483|||||TWO_SIDED|90.0|0.8977|1.0018|||||Switching group vs Continued-use group.|The ratio of geometric LS means, and 90% CIs were estimated using the ANCOVA model adjusted for the actual stratification factors if prior biologic use for psoriasis, baseline body weight group, geographic region, and PK trough concentration at week 28.||1.0018|0.8977|
71771186|NCT04761627|143042182|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9617|||||TWO_SIDED|90.0|0.8319|1.1119|||||Ctrough,ss at Week 28: Switching group vs Continued-use group|The ratio of Geometric LS means, and 90% CI for Ctrough,ss at week 28 were estimated based on an ANCOVA model adjusted for the actual stratification factors of prior biologic use for psoriasis, baseline body weight group, and geographic region.||1.1119|0.8319|
71888712|NCT00510276|143298390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.002|TWO_SIDED|95.0|-2.19|-0.47|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.47|-2.19|0.002
71888713|NCT00510276|143298391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.045|TWO_SIDED|95.0|-1.04|-0.01|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.01|-1.04|0.045
71888714|NCT00510276|143298392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.001|TWO_SIDED|95.0|-1.35|-0.32|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.32|-1.35|0.001
71888715|NCT00510276|143298393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.008|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.19|-1.23|0.008
71888716|NCT00510276|143298394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.98|-0.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||-0.63|-1.98|<0.001
71888717|NCT00510276|143298395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.065|TWO_SIDED|95.0|-1.42|0.04|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.||0.04|-1.42|0.065
71728342|NCT01509677|142971565|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0257|TWO_SIDED|95.0|1.2|19.0|||ANCOVA|||2-sided 5% test||19.0|1.2|0.0257
71728343|NCT01509677|142971566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|18.11||0.0728|TWO_SIDED|95.0|-3.0|168.6|||ANCOVA|||2-sided 5% test||168.6|-3.0|0.0728
71728344|NCT01509677|142971567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.03||0.038|TWO_SIDED|95.0|0.004|0.122|||ANCOVA|||2-sided 5% test||0.122|0.004|0.0380
71728345|NCT01509677|142971568|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.0552||0.2482|TWO_SIDED|95.0|-0.045|0.173|||ANCOVA|||2-sided 5% test||0.173|-0.045|0.2482
71728346|NCT01509677|142971569|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.0||||0.2629|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|Between treatment difference||2 sided 5 % test||1.00|-2.00|0.2629
71728347|NCT02124512|142971570|SUPERIORITY||||||>|0.05||||||The p-value was calculated to be \>0.05.|ANOVA|||Comparison of the pre- and post-treatment timecourse between untreated and rifaximin-treated participants.||||>0.05
71728348|NCT02124512|142971571|SUPERIORITY|||||||0.12||||||unpaired Student's t-test|t-test, 2 sided|||Treatment difference (change in placebo pre- and post-treatment versus change in rifaximin pre- and post-treatment).||||0.12
71728349|NCT01431014|142971573|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||>0.05
71728350|NCT01779869|142971622|SUPERIORITY|Accuracy was assessed compared to an imaging reference standard.||||||0.35|||||||Chi-squared|||Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value \< 0.05 was considered significant.||||0.35
71728351|NCT01459653|142971628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.884||||0.3038|TWO_SIDED|95.0|0.6989|1.1182|||Chi-squared|||||1.1182|0.6989|0.3038
71728352|NCT01459653|142971629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1897||||0.1432|TWO_SIDED|95.0|0.9428|1.5012|||Chi-squared|||||1.5012|0.9428|0.1432
71728353|NCT01459653|142971630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8794||||0.6483|TWO_SIDED|95.0|0.5063|1.5276|||Chi-squared|||||1.5276|0.5063|0.6483
71728354|NCT01459653|142971640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2989|||<|0.0001|TWO_SIDED|95.0|1.8113|2.9177|||Chi-squared|||||2.9177|1.8113|<0.0001
71728355|NCT01459653|142971641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4963|||<|0.0001|TWO_SIDED|95.0|0.373|0.6605|||Chi-squared|||||0.6605|0.3730|<0.0001
71728356|NCT01459653|142971642|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9451||||0.7509|TWO_SIDED|95.0|0.6671|1.3391|||Chi-squared|||||1.3391|0.6671|0.7509
71728357|NCT01459653|142971643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2683||||0.0067|TWO_SIDED|95.0|1.068|1.5061|||Chi-squared|||||1.5061|1.0680|0.0067
71728358|NCT01459653|142971651|SUPERIORITY_OR_OTHER||Slope|1.0628|||<|0.0001|TWO_SIDED|95.0|0.6382|1.4874|||ANOVA|degrees of freedom: 4507||||1.4874|0.6382|<0.0001
71728359|NCT01459653|142971652|SUPERIORITY_OR_OTHER||Slope|-0.2739||||0.0103|TWO_SIDED|95.0|-0.4832|-0.0646|||ANOVA|degrees of freedom: 4507||||-0.0646|-0.4832|0.0103
71728360|NCT01459653|142971653|SUPERIORITY_OR_OTHER||Slope|0.3812|||<|0.0001|TWO_SIDED|95.0|0.233|0.5295|||ANOVA|degrees of freedom: 4495||||0.5295|0.2330|<0.0001
71728361|NCT01459653|142971661|SUPERIORITY_OR_OTHER||Slope|0.1031||||0.0677|TWO_SIDED|95.0|-0.0075|0.2136|||ANOVA|degrees of freedom: 4516||||0.2136|-0.0075|0.0677
71728362|NCT01459653|142971662|SUPERIORITY_OR_OTHER||Slope|0.0018||||0.8968|TWO_SIDED|95.0|-0.0259|0.0295|||ANOVA|degrees of freedom: 4516||||0.0295|-0.0259|0.8968
71728363|NCT01459653|142971663|SUPERIORITY_OR_OTHER||Slope|0.0741|||<|0.0001|TWO_SIDED|95.0|-0.0452|0.1029|||ANOVA|degrees of freedom: 4505||||0.1029|-0.0452|<0.0001
71728364|NCT01459653|142971671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.2698|TWO_SIDED|95.0|0.4255|1.2698|||Chi-squared|||||1.2698|0.4255|0.2698
71728365|NCT01459653|142971672|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71728366|NCT01459653|142971689|SUPERIORITY_OR_OTHER|||||||0.5977|TWO_SIDED||||||Log Rank|||||||0.5977
71728367|NCT01459653|142971690|SUPERIORITY_OR_OTHER|||||||0.2435|TWO_SIDED||||||Log Rank|||||||0.2435
71728368|NCT01459653|142971691|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||Log Rank|||||||0.7630
71728369|NCT01459653|142971692|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED||||||Log Rank|||||||0.3830
71771187|NCT04761627|143042182|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geometric LS Means Ratio|0.9662|||||TWO_SIDED|90.0|0.8879|1.0515|||||Ctrough,ss at Week 40: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 40 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0515|0.8879|
71728370|NCT01459653|142971693|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Log Rank|||||||0.0002
71728371|NCT01459653|142971694|SUPERIORITY_OR_OTHER|||||||0.0301|TWO_SIDED||||||Log Rank|||||||0.0301
71728372|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|0.92||||0.0683|TWO_SIDED|95.0|0.84|1.01|||Regression, Logistic|degrees of freedom: 3181||GCSF treatment decision (under vs correct) as predictor for ANC||1.01|0.84|0.0683
71728373|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|0.89||||0.0019|TWO_SIDED|95.0|0.82|0.96|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Over vs correct) as predictor for ANC||0.96|0.82|0.0019
71728374|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|1.04||||0.4469|TWO_SIDED|95.0|0.94|1.15|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Under vs over) as predictor for ANC||1.15|0.94|0.4469
71728375|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|1.11||||0.0079|TWO_SIDED|95.0|1.03|1.19|||Regression, Logistic|||Study drug dose (higher vs lower) as predictor for ANC||1.19|1.03|0.0079
71728376|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|0.81||||0.0004|TWO_SIDED|95.0|0.72|0.91|||Regression, Logistic|||Tumor type (hematological vs solid) as predictor for ANC||0.91|0.72|0.0004
71728377|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.92|||Regression, Logistic|||Patient gender (female vs male) as predictor for ANC||0.92|0.80|<0.0001
71728378|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|1.04||||0.0235|TWO_SIDED|95.0|1.01|1.08|||Regression, Linear|||ECOG (per 1 point) as predictor for ANC||1.08|1.01|0.0235
71728379|NCT01459653|142971695|SUPERIORITY_OR_OTHER||Slope|1.03|||<|0.0001|TWO_SIDED|95.0|1.02|1.05|||Regression, Linear|||Hb (per g/dL) as predictor for ANC||1.05|1.02|<0.0001
71728380|NCT01459653|142971696|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.09||||0.0003|TWO_SIDED||||||ANCOVA||The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.|ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.||||0.0003
71728381|NCT01459653|142971696|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.41|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.||||<0.0001
71728382|NCT01459653|142971696|SUPERIORITY_OR_OTHER||Intra-class correlation coefficient|0.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.||||<0.0001
71728383|NCT01459653|142971701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.544||||0.003|TWO_SIDED|95.0|0.365|0.812|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode||0.812|0.365|0.003
71728384|NCT01459653|142971701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.795|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
71728385|NCT01459653|142971701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.083|||<|0.001|TWO_SIDED|95.0|3.242|7.092|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode||7.092|3.242|<0.001
71728386|NCT01459653|142971701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.542|3.925|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||3.925|1.542|<0.001
71728387|NCT01459653|142971701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.452||||0.003|TWO_SIDED|95.0|0.267|0.766|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.766|0.267|0.003
71728388|NCT01459653|142971702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.925||||0.001|TWO_SIDED|95.0|1.592|5.374|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode||5.374|1.592|0.001
71728389|NCT01459653|142971702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.572||||0.005|TWO_SIDED|95.0|1.331|4.969|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode||4.969|1.331|0.005
71728390|NCT01459653|142971702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.328|||<|0.001|TWO_SIDED|95.0|0.193|0.557|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode||0.557|0.193|<0.001
71728391|NCT01459653|142971703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.673|||<|0.001|TWO_SIDED|95.0|1.284|2.179|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for FN episode||2.179|1.284|<0.001
71728392|NCT01459653|142971703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.704|||<|0.001|TWO_SIDED|95.0|2.777|7.968|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode||7.968|2.777|<0.001
71728393|NCT01459653|142971703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.002|TWO_SIDED|95.0|1.342|3.574|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for FN episode||3.574|1.342|0.002
71728394|NCT01459653|142971703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.215||||0.01|TWO_SIDED|95.0|0.067|0.687|||Regression, Logistic|||History of anaemia at enrollment as patient-level predictor for FN episode||0.687|0.067|0.010
71728395|NCT01459653|142971703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.501||||0.025|TWO_SIDED|95.0|1.169|10.487|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||10.487|1.169|0.025
71728396|NCT01459653|142971704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.975||||0.003|TWO_SIDED|95.0|0.958|0.991|||Regression, Logistic|||Patient age (per 1 year) as patient-level predictor for FN episode||0.991|0.958|0.003
71728397|NCT01459653|142971704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.398|||<|0.001|TWO_SIDED|95.0|1.61|3.57|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for FN episode||3.570|1.610|<0.001
71728398|NCT01459653|142971704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.562||||0.001|TWO_SIDED|95.0|1.45|4.527|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for FN episode||4.527|1.450|0.001
71728399|NCT01459653|142971704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.232|||<|0.001|TWO_SIDED|95.0|0.108|0.499|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for FN episode||0.499|0.108|<0.001
71728400|NCT01459653|142971704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.261||||0.011|TWO_SIDED|95.0|1.315|8.084|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode||8.084|1.315|0.011
71728401|NCT01459653|142971705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.814|||<|0.001|TWO_SIDED|95.0|1.397|2.355|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization||2.355|1.397|<0.001
71888718|NCT00510276|143298396|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Cochran-Mantel-Haenszel|Tested was smoking status across treatment.||Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo||||0.788
71728402|NCT01459653|142971705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.296|||<|0.001|TWO_SIDED|95.0|1.791|6.065|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization||6.065|1.791|<0.001
71728403|NCT01459653|142971705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.205||||0.001|TWO_SIDED|95.0|1.38|3.524|||Regression, Logistic|||CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization||3.524|1.380|0.001
71728404|NCT01459653|142971705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.863||||0.032|TWO_SIDED|95.0|1.054|3.293|||Regression, Logistic|||Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||3.293|1.054|0.032
71728405|NCT01459653|142971705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.385||||0.024|TWO_SIDED|95.0|0.168|0.879|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.879|0.168|0.024
71728406|NCT01459653|142971705|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.843||||0.001|TWO_SIDED|95.0|1.964|11.942|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||11.942|1.964|0.001
71728407|NCT01459653|142971706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.473|||<|0.001|TWO_SIDED|95.0|1.55|3.946|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization||3.946|1.550|<0.001
71728408|NCT01459653|142971706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.382||||0.002|TWO_SIDED|95.0|0.21|0.695|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization||0.695|0.210|0.002
71728409|NCT01459653|142971706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.108||||0.001|TWO_SIDED|95.0|1.56|6.192|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization||6.192|1.560|0.001
71728410|NCT01459653|142971707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.931|||<|0.001|TWO_SIDED|95.0|5.426|14.699|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance||14.699|5.426|<0.001
71728411|NCT01459653|142971707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.336||||0.007|TWO_SIDED|95.0|0.152|0.74|||Regression, Logistic|||Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance||0.740|0.152|0.007
71728412|NCT01459653|142971707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.006|TWO_SIDED|95.0|0.999|1.0|||Regression, Logistic|||Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.000|0.999|0.006
71728413|NCT01459653|142971707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001|||<|0.001|TWO_SIDED|95.0|1.0|1.001|||Regression, Logistic|||Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance||1.001|1.000|<0.001
71728414|NCT01459653|142971707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.456||||0.024|TWO_SIDED|95.0|1.127|5.353|||Regression, Logistic|||Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||5.353|1.127|0.024
71728415|NCT01459653|142971707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.344||||0.01|TWO_SIDED|95.0|1.342|8.331|||Regression, Logistic|||Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance||8.331|1.342|0.010
71728416|NCT01459653|142971708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.965||||0.006|TWO_SIDED|95.0|1.218|3.172|||Regression, Logistic|||Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance||3.172|1.218|0.006
71728417|NCT01459653|142971708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.594||||0.001|TWO_SIDED|95.0|1.469|4.581|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance||4.581|1.469|0.001
71728418|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.424|0.821|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.821|0.424|0.002
71728419|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.644||||0.003|TWO_SIDED|95.0|0.489|0.859|||Regression, Logistic|||Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.859|0.489|0.003
71728420|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.004|TWO_SIDED|95.0|0.398|0.842|||Regression, Logistic|||Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.842|0.398|0.004
71728421|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.369||||0.001|TWO_SIDED|95.0|1.14|1.643|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||1.643|1.140|0.001
71728422|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.499|||<|0.001|TWO_SIDED|95.0|2.456|4.985|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||4.985|2.456|<0.001
71728423|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.064|||<|0.001|TWO_SIDED|95.0|3.096|5.336|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.336|3.096|<0.001
71728424|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.545||||0.002|TWO_SIDED|95.0|1.175|2.033|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.033|1.175|0.002
71728425|NCT01459653|142971709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.596||||0.017|TWO_SIDED|95.0|1.088|2.34|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.340|1.088|0.017
71728426|NCT01459653|142971710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.621||||0.006|TWO_SIDED|95.0|1.152|2.281|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.281|1.152|0.006
71728427|NCT01459653|142971710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.898||||0.005|TWO_SIDED|95.0|1.209|2.979|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||2.979|1.209|0.005
71728428|NCT01459653|142971710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.016|TWO_SIDED|95.0|1.2|5.984|||Regression, Logistic|||History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||5.984|1.200|0.016
71728429|NCT01459653|142971710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438|||<|0.001|TWO_SIDED|95.0|0.291|0.66|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.660|0.291|<0.001
71728430|NCT01459653|142971710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.053||||0.002|TWO_SIDED|95.0|1.295|3.256|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||3.256|1.295|0.002
71728431|NCT01459653|142971710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.558||||0.028|TWO_SIDED|95.0|0.332|0.939|||Regression, Logistic|||GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)||0.939|0.332|0.028
71728432|NCT01459653|142971711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2064||||0.0116|TWO_SIDED|95.0|1.1931|4.0803|||Regression, Logistic|||Patient level predictor: History of anemia at enrollment||4.0803|1.1931|0.0116
71728433|NCT01459653|142971711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3049||||0.0057|TWO_SIDED|95.0|1.2754|4.1656|||Regression, Logistic|||Liver/renal/cardiac comorbidity as patient level predictor||4.1656|1.2754|0.0057
71728434|NCT01459653|142971711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.535|||<|0.0001|TWO_SIDED|95.0|8.2159|37.4243|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient level predictor||37.4243|8.2159|<0.0001
71728435|NCT01459653|142971715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Female gender as patient-level predictor for cancer-related mortality||37.1225|5.9567|<0.0001
71728436|NCT01459653|142971715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8703|||<|0.0001|TWO_SIDED|95.0|5.9567|37.1225|||Regression, Logistic|||Poor performance (ECOG \>=2) during study as patient-level predictor||37.1225|5.9567|<0.0001
71728437|NCT03315104|142971806|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.174|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV High Dose (450 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.174
71728438|NCT03315104|142971806|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Mean Difference (Net)|0.0||||0.572|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.572
71728439|NCT03315104|142971806|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons. two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test||Pairwise Wilcoxon rank-sum test for a location shift||1.000|0.000|0.534
71728440|NCT03315104|142971806|SUPERIORITY|A median estimated value of 0.000 indicates no difference between groups.|Median Difference (Net)|0.0||||0.534|TWO_SIDED|95.0|0.0|1.0||No adjustment for multiple comparisons, two-sided significance level of 0.05|Wilcoxon (Mann-Whitney)|Exact test|FLU-IGIV pooled (450 mL + 250 mL) - Placebo|Pairwise Wilcoxon rank-sum test for a location shift where the two active dose groups were pooled and compared to placebo.||1.000|0.000|0.534
71728441|NCT00027378|142971807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.702||0.05||95.0|||||ANOVA|repeated measures||Repeated measures ANOVA||||.05
71728442|NCT03199053|142971837|SUPERIORITY||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.274|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||||-0.49|-1.57|< 0.001
71728443|NCT03199053|142971838|SUPERIORITY||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.251||0.078|TWO_SIDED|95.0|-0.93|0.05|||ANCOVA|||||0.05|-0.93|0.078
71728444|NCT03199053|142971839|SUPERIORITY||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.3||0.004|TWO_SIDED|95.0|-1.44|-0.27|||ANCOVA|||||-0.27|-1.44|0.004
71728445|NCT03199053|142971840|SUPERIORITY||Adjusted mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.277||0.067|TWO_SIDED|95.0|-1.05|0.04|||ANCOVA|||||0.04|-1.05|0.067
71728446|NCT03199053|142971841|SUPERIORITY||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.76|-0.62|||ANCOVA|||||-0.62|-1.76|< 0.001
71728447|NCT03199053|142971842|SUPERIORITY||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.146|TWO_SIDED|95.0|-0.92|0.14|||ANCOVA|||||0.14|-0.92|0.146
71728448|NCT03199053|142971843|SUPERIORITY||Adjusted mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.479||0.024|TWO_SIDED|95.0|-2.02|-0.14|||ANCOVA|||||-0.14|-2.02|0.024
71728449|NCT03199053|142971844|SUPERIORITY||Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.528||0.833|TWO_SIDED|95.0|-1.15|0.92|||ANCOVA|||||0.92|-1.15|0.833
71728450|NCT03199053|142971845|SUPERIORITY||Adjusted mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.525||0.047|TWO_SIDED|95.0|-2.07|-0.01|||ANCOVA|||||-0.01|-2.07|0.047
71728451|NCT03199053|142971846|SUPERIORITY||Adjusted mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.49||0.268|TWO_SIDED|95.0|-1.5|0.42|||ANCOVA|||||0.42|-1.50|0.268
71728452|NCT03199053|142971847|SUPERIORITY||Adjusted mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.505||0.026|TWO_SIDED|95.0|-2.11|-0.13|||ANCOVA|||||-0.13|-2.11|0.026
71771188|NCT04761627|143042182|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Geomtric LS Means Ratio|0.9806|||||TWO_SIDED|90.0|0.8916|1.0785|||||Ctrough,ss at Week 52: Switching group vs Continued-use group|The ratio of geometric LS means, and 90% CI for Ctrough,ss at week 52 between the 2 treatment groups were estimated using an ANCOVA model adjusting for stratification factors and PK trough concentration at week 28.||1.0785|0.8916|
71771189|NCT04761627|143042183|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Mean difference|0.07|||||TWO_SIDED|90.0|-2.62|2.77|||||Mean difference in PASI percent improvement from baseline at Week 64: Switching group - Continued-use group|Multiple imputation was applied for the point estimate and CI of the mean difference between the switching and continued-use groups. Missing PASI scores at the week 64 visit were imputed by MI.||2.77|-2.62|
71771190|NCT04761627|143042184|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-5.7|6.2|||||Response difference in PASI 75 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||6.2|-5.7|
71771191|NCT04761627|143042185|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Response difference|0.2|||||TWO_SIDED|90.0|-7.4|7.8|||||Response difference in PASI 100 Response at Week 64: Switching group - Continued-use group|Response difference was estimated by the Mantel-Haenszel estimate, and the 90% CIs were estimated by the stratified Newcombe confidence limits, adjusting for the prior biologic use of psoriasis, baseline body weight group, geographic region. Missing post-baseline binary response data were imputed by NRI.||7.8|-7.4|
71771192|NCT04761627|143042187|EQUIVALENCE|The prespecified similarity margin was 0.8 to 1.25.|Risk Difference (RD)|-0.48|||||TWO_SIDED|90.0|-4.17|3.1|||||Switching group - continued-use group|Risk difference for any EOI: risk difference and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.||3.10|-4.17|
71728453|NCT03199053|142971848|SUPERIORITY||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.618||0.644|TWO_SIDED|95.0|-0.92|1.5|||ANCOVA|||||1.50|-0.92|0.644
71728454|NCT03199053|142971849|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.019|TWO_SIDED|95.0|1.2|11.7|||Regression, Logistic|||||11.7|1.2|0.019
71728455|NCT03199053|142971849|SUPERIORITY||Adjusted Odds Ratio|2.6||||0.114|TWO_SIDED|95.0|0.8|8.6|||Regression, Logistic|||||8.6|0.8|0.114
71728456|NCT03199053|142971850|SUPERIORITY||Adjusted Odds Ratio|3.5||||0.042|TWO_SIDED|95.0|1.0|11.4|||Weighted Logistic Regression|||||11.4|1.0|0.042
71728457|NCT03199053|142971850|SUPERIORITY||Adjusted Odds Ratio|2.3||||0.175|TWO_SIDED|95.0|0.7|7.4|||Weighted Logistic Regression|||||7.4|0.7|0.175
71728458|NCT03199053|142971851|SUPERIORITY||Adjusted Odds Ratio|4.4||||0.009|TWO_SIDED|95.0|1.4|13.2|||Weighted Logistic Regression|||||13.2|1.4|0.009
71728459|NCT03199053|142971851|SUPERIORITY||Adjusted Odds Ratio|3.8||||0.042|TWO_SIDED|95.0|1.1|13.5|||Weighted Logistic Regression|||||13.5|1.1|0.042
71728460|NCT03199053|142971852|SUPERIORITY||Adjusted mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.496||0.955|TWO_SIDED|95.0|-1.0|0.94|||ANCOVA|||||0.94|-1.00|0.955
71728461|NCT03199053|142971852|SUPERIORITY||Adjusted mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.495||0.64|TWO_SIDED|95.0|-1.2|0.74|||ANCOVA|||||0.74|-1.20|0.640
71728462|NCT03199053|142971853|SUPERIORITY||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.896||0.476|TWO_SIDED|95.0|-2.39|1.12|||ANCOVA|||||1.12|-2.39|0.476
71728463|NCT03199053|142971853|SUPERIORITY||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|1.017||0.075|TWO_SIDED|95.0|-3.81|0.18|||ANCOVA|||||0.18|-3.81|0.075
71728464|NCT03199053|142971854|SUPERIORITY||Unadjusted Difference in Percentage|-19.7||||0.182|TWO_SIDED|95.0|-44.5|5.7|||Fisher Exact|||||5.7|-44.5|0.182
71728465|NCT03199053|142971855|SUPERIORITY||Unadjusted Difference in Percentage|-6.3||||0.65|TWO_SIDED|95.0|-29.8|16.5|||Fisher Exact|||||16.5|-29.8|0.650
71728466|NCT00246025|142971870|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155||95.0|-30.2|-3.4||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-3.4|-30.2|0.0155
71728467|NCT00246025|142971870|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006||95.0|-37.0|-10.5||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-10.5|-37.0|0.0006
71888719|NCT00510276|143298397|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||Tested was smoking status across treatment.|Cochran-Mantel-Haenszel|||Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo||||0.482
71728468|NCT00246025|142971870|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001||95.0|-45.4|-19.6||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-19.6|-45.4|<0.0001
71728469|NCT00246025|142971871|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.0|-9.1|0.1124
71728470|NCT00246025|142971871|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||1.1|-9.1|0.1183
71728471|NCT00246025|142971871|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||-1.3|-10.3|0.0138
71728472|NCT00246025|142971872|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.0|-9.1|0.1124
71728473|NCT00246025|142971872|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||1.1|-9.1|0.1183
71771193|NCT01634178|143042203|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% confidence interval (CI) of the geometric least squares (LS) mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric Least Squares Means|98.3|||||TWO_SIDED|90.0|90.7|106.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||106.6|90.7|
71888720|NCT03486392|143298403|SUPERIORITY||Difference of least square (LS) Means|-6.75|STANDARD_ERROR_OF_MEAN|1.056|<|0.001|TWO_SIDED|95.0|-9.31|-4.19|||Dunnett's method|||||-4.19|-9.31|< 0.001
71888721|NCT03486392|143298403|SUPERIORITY||Difference of LS Means|-8.07|STANDARD_ERROR_OF_MEAN|0.921|<|0.001|TWO_SIDED|95.0|-10.31|-5.84|||Dunnett's method|||||-5.84|-10.31|< 0.001
71728474|NCT00246025|142971872|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-1.3|-10.3|0.0138
71728475|NCT00246025|142971873|SUPERIORITY_OR_OTHER|||||||0.6107||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6107
71888722|NCT03486392|143298403|SUPERIORITY||Difference of LS Means|-10.04|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-12.31|-7.78|||Dunnett's method|||||-7.78|-12.31|< 0.001
71888723|NCT03486392|143298403|SUPERIORITY||Difference of LS Means|-5.78|STANDARD_ERROR_OF_MEAN|0.91|<|0.001|TWO_SIDED|95.0|-7.99|-3.57|||Dunnett's method|||||-3.57|-7.99|< 0.001
71888724|NCT01107444|143298462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||||||The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.|t-test, 1 sided|||||||0.284
71728476|NCT00246025|142971873|SUPERIORITY_OR_OTHER|||||||1||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||1.0000
71728477|NCT00246025|142971873|SUPERIORITY_OR_OTHER|||||||0.6162||95.0||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher's exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||||0.6162
71728478|NCT00246025|142971874|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-16.8||||0.0155|TWO_SIDED|95.0|-30.2|-3.4||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-3.4|-30.2|0.0155
71728479|NCT00246025|142971874|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-23.7||||0.0006|TWO_SIDED|95.0|-37.0|-10.5||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-10.5|-37.0|0.0006
71728480|NCT00246025|142971874|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-32.5|||<|0.0001|TWO_SIDED|95.0|-45.4|-19.6||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."||-19.6|-45.4|<.0001
71728481|NCT00246025|142971877|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||1.0000
71728482|NCT00246025|142971877|SUPERIORITY_OR_OTHER|||||||0.496||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.4960
71728483|NCT00246025|142971877|SUPERIORITY_OR_OTHER|||||||0.6223||95.0|||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events||||0.6223
71728484|NCT00246025|142971877|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.5||||0.1513|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1513
71728485|NCT00246025|142971877|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|-2.4||||0.1696|TWO_SIDED|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||1.0|-5.9|0.1696
71728486|NCT00246025|142971877|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.7||||0.7802|TWO_SIDED|95.0|-3.9|5.2|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events||5.2|-3.9|0.7802
71728487|NCT00246025|142971877|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.7||||0.6313|TWO_SIDED|95.0|-5.3|8.7|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||8.7|-5.3|0.6313
71728488|NCT00246025|142971877|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.3||||0.5377|TWO_SIDED|95.0|-4.9|9.4|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||9.4|-4.9|0.5377
71728489|NCT00246025|142971877|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|2.8||||0.4493|TWO_SIDED|95.0|-4.4|10.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events||10.0|-4.4|0.4493
71728490|NCT00909545|142971881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|2.03||0.9834|TWO_SIDED|95.0|-3.99|4.07||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.||4.07|-3.99|0.9834
71728491|NCT00909545|142971881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.97||0.5761|TWO_SIDED|95.0|-5.01|2.8||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.||2.80|-5.01|0.5761
71771194|NCT01634178|143042205|OTHER||Median Difference|0.75||||0.0077|TWO_SIDED|90.0|0.25|1.25|||Wilcoxon signed-rank test||Median difference (Fed - Fasted) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.25|0.25|0.0077
71771195|NCT01634178|143042206|OTHER|Food was considered to have no effect on the PK of apremilast if the 90% CI of the geometric LS mean ratios for AUC0-t and Cmax were completely contained within the range of 80% to 125%.|Ratio of Geometric LS Means|112.4|||||TWO_SIDED|90.0|109.3|115.6|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an analysis of variance model (ANOVA) with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||115.6|109.3|
71771196|NCT01634178|143042207|OTHER||Ratio of Geometric Least Squares Means|112.0|||||TWO_SIDED|90.0|108.9|115.1|||||Ratio of the geometric LS means (Fed/Fasted), reported as percentages.|To assess the food effect, an ANOVA with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||115.1|108.9|
71771197|NCT02757950|143042220|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.548||||0.1147|TWO_SIDED|95.0|0.259|1.157||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.157|0.259|0.1147
71771198|NCT02757950|143042221|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.428||||0.0155|TWO_SIDED|95.0|0.215|0.851||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.851|0.215|0.0155
71771199|NCT02757950|143042222|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.254||||0.0127|TWO_SIDED|95.0|0.086|0.746||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.746|0.086|0.0127
71771200|NCT02757950|143042223|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.638||||0.0036|TWO_SIDED|95.0|0.471|0.863||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||0.863|0.471|0.0036
71771201|NCT02757950|143042224|OTHER|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|1.342||||0.0931|TWO_SIDED|95.0|0.952|1.89||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.||1.890|0.952|0.0931
71771202|NCT00251004|143042303|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|2.2||||0.001|TWO_SIDED|95.0|-2.9|7.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||7.3|-2.9|0.001
71888725|NCT01948830|143298475|NON_INFERIORITY_OR_EQUIVALENCE|The following hypothesis was tested at a one-sided 0.025 level. Non-inferiority with respect to BCVA: H01: μtreat and extend - μmonthly ≤ - Δ versus HA1: μtreat and extend - μmonthly \> - Δ where μtreat and extend and μmonthly are the unknown mean changes from baseline in BCVA to Month 12 in the treat and extend regimen and the monthly regimen, respectively. Δ is the non-inferiority margin and is pre-defined to be 5 letters for the justification of the margin.|||||<|0.001|||||||ANCOVA|||||||<0.001
71888726|NCT01260454|143298503|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||This is open-label, uncontrolled data; the comparison is made between each individual's baseline.||||0.03
71658493|NCT01000493|142832092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.8954|TWO_SIDED|95.0|-4.36|3.83||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.|||3.83|-4.36|0.8954
71658494|NCT01941940|142832106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658495|NCT01941940|142832112|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71888727|NCT02525549|143298526|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|93.12|||||TWO_SIDED|90.0|88.6|102.0|||Fieller's method|||||102.00|88.6|
71658496|NCT01941940|142832114|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658497|NCT01941940|142832114|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658498|NCT01941940|142832114|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658499|NCT01941940|142832115|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658500|NCT01941940|142832115|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658501|NCT01941940|142832115|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658502|NCT01941940|142832118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658503|NCT01941940|142832118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658504|NCT01941940|142832118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658505|NCT01941940|142832118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658506|NCT01941940|142832118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658507|NCT01941940|142832118|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658508|NCT01941940|142832119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658509|NCT01941940|142832119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658510|NCT01941940|142832119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658511|NCT01941940|142832119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658512|NCT01941940|142832119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658513|NCT01941940|142832119|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658514|NCT01941940|142832120|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 2||||<0.0001
71658515|NCT01941940|142832120|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 24||||<0.0001
71658516|NCT01941940|142832120|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 52||||<0.0001
71658517|NCT01941940|142832121|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 2||||<0.0001
71658518|NCT01941940|142832121|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 24||||<0.0001
71658519|NCT01941940|142832121|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 52||||<0.0001
71658520|NCT01941940|142832122|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 2||||<0.0001
71658521|NCT01941940|142832122|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 24||||<0.0001
71658522|NCT01941940|142832122|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 52||||<0.0001
71658523|NCT01941940|142832123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 2||||<0.0001
71658524|NCT01941940|142832123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 2||||<0.0001
71658525|NCT01941940|142832123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 2||||<0.0001
71658526|NCT01941940|142832123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 24||||<0.0001
71658527|NCT01941940|142832123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 24||||<0.0001
71658528|NCT01941940|142832123|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 24||||<0.0001
71658529|NCT01941940|142832123|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 52||||0.0004
71888728|NCT02525549|143298527|NON_INFERIORITY|provides 85% power of success|Equivalence ratio|98.7|||||TWO_SIDED|90.0|92.3|109.4|||Fieller's method|||||109.4|92.3|
71728492|NCT00909545|142971881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|2.01||0.322|TWO_SIDED|95.0|-5.98|1.99||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.||1.99|-5.98|0.322
71658530|NCT01941940|142832123|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 52||||0.0004
71728493|NCT00909545|142971882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|STANDARD_ERROR_OF_MEAN|1.1587||0.1383|TWO_SIDED|95.0|0.0196|1.8411|||Fisher Exact|||The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||1.8411|0.0196|0.1383
71728494|NCT00909545|142971882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1086|STANDARD_ERROR_OF_MEAN|0.1114||0.0248|TWO_SIDED|95.0|0.0123|0.9591|||Fisher Exact|||The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.9591|0.0123|0.0248
71728495|NCT00909545|142971882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.024|STANDARD_ERROR_OF_MEAN|1.1035|<|0.0001|TWO_SIDED|95.0|0.0028|0.2087|||Fisher Exact|||The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.||0.2087|0.0028|<0.0001
71728496|NCT00909545|142971883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.38||0.2324|TWO_SIDED|95.0|-0.3|1.22|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||1.22|-0.30|0.2324
71728497|NCT00909545|142971883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.73|0.73|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||0.73|-0.73|1
71728498|NCT00909545|142971883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.37||0.4675|TWO_SIDED|95.0|-1.02|0.47|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.47|-1.02|0.4675
71728499|NCT00909545|142971884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4648|TWO_SIDED|95.0|-1.03|2.23|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.23|-1.03|0.4648
71728500|NCT00909545|142971884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.8||0.525|TWO_SIDED|95.0|-2.09|1.07|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||1.07|-2.09|0.525
71728501|NCT00909545|142971884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.81||0.3674|TWO_SIDED|95.0|-2.36|0.88|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||0.88|-2.36|0.3674
71728502|NCT00909545|142971885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.579|TWO_SIDED|95.0|-3.8|2.14|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.||2.14|-3.80|0.579
71728503|NCT00909545|142971885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.46||0.7778|TWO_SIDED|95.0|-3.3|2.48|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.||2.48|-3.30|0.7778
71888729|NCT02238847|143298528|NON_INFERIORITY|The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.|||||<|0.01||||||Reported p-value of \<0.01 is calculated p-value. (p\<0.05 was considered significant)|Exact Non-inferiority|||||||<0.01
71728504|NCT00909545|142971885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|1.48||0.669|TWO_SIDED|95.0|-3.58|2.31|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.||2.31|-3.58|0.669
71728505|NCT00909545|142971886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6677|TWO_SIDED|95.0|-0.27|0.17|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.||0.17|-0.27|0.6677
71728506|NCT00909545|142971886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.1755|TWO_SIDED|95.0|-0.36|0.07|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.||0.07|-0.36|0.1755
71728507|NCT00909545|142971886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1463|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Change in Modified Hoehn \& Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.||0.06|-0.38|0.1463
71658531|NCT01941940|142832123|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 52||||0.0004
71658532|NCT01941940|142832124|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 2||||<0.0001
71728508|NCT00909545|142971887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7111|TWO_SIDED|95.0|-3.3|2.26|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.||2.26|-3.30|0.7111
71728509|NCT00909545|142971887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|1.36||0.3237|TWO_SIDED|95.0|-1.35|4.04|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.||4.04|-1.35|0.3237
71728510|NCT00909545|142971887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|1.4||0.3658|TWO_SIDED|95.0|-1.51|4.05|||ANCOVA|||Change in Modified Schwab \& England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.||4.05|-1.51|0.3658
71728511|NCT00909545|142971888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.32||0.0608|TWO_SIDED|95.0|-0.12|5.13|||ANCOVA|||Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.||5.13|-0.12|0.0608
71728512|NCT00909545|142971888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|1.36||0.6445|TWO_SIDED|95.0|-2.07|3.33|||ANCOVA|||Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.||3.33|-2.07|0.6445
71728513|NCT00909545|142971888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.52||0.1336|TWO_SIDED|95.0|-0.63|4.67|||ANCOVA|||Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.||4.67|-0.63|0.1336
71771203|NCT00251004|143042303|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in Percentage|0.3|||<|0.001|TWO_SIDED|95.0|-4.6|5.2||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \<10%.||5.2|-4.6|<0.001
71771204|NCT00251004|143042304|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|1.8||||0.014|TWO_SIDED|95.0|-5.5|9.1||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z - test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is \<10%.||9.1|-5.5|0.014
71831088|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7799|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.08|0.7799
71831089|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0061|TWO_SIDED|95.0|-0.16|-0.03|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.16|0.0061
71831090|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9718|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9718
71831091|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3292|TWO_SIDED|95.0|-0.14|0.05|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.05|-0.14|0.3292
71831092|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.983|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9830
71831093|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.9137|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.9137
71888730|NCT02238847|143298529|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
71771205|NCT00251004|143042304|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%.|Difference in percentage|-3.8|||<|0.001|TWO_SIDED|95.0|-10.8|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is \<10%.||3.3|-10.8|<0.001
71831094|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8784|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.11|0.8784
71831095|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9995|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.10|0.9995
71831096|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.6648|TWO_SIDED|95.0|-0.13|0.08|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.13|0.6648
71831097|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.728|TWO_SIDED|95.0|-0.09|0.12|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.09|0.7280
71888731|NCT03430986|143298549|SUPERIORITY||Least Squares (LS) Mean Difference|2.037|STANDARD_ERROR_OF_MEAN|0.1578|<|0.0001|TWO_SIDED|95.0|1.726|2.349|||MMRM|MMRM included treatment, timepoint, treatment-by-timepoint interaction as fixed effect using an unstructured covariance matrix.||||2.349|1.726|<0.0001
71658533|NCT01941940|142832124|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 24||||<0.0001
71658534|NCT01941940|142832124|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 52||||<0.0001
71728514|NCT00909545|142971889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.56||0.3533|TWO_SIDED|95.0|-1.64|0.59|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.||0.59|-1.64|0.3533
71728515|NCT00909545|142971889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.56||0.4045|TWO_SIDED|95.0|-1.59|0.65|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.||0.65|-1.59|0.4045
71771206|NCT00251004|143042305|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|2.42|||<|0.001|TWO_SIDED|95.0|-1.6|6.5||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||6.5|-1.6|<0.001
71771207|NCT00251004|143042305|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at -8 mL/min/1.73m\^2.|Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-4.9|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\^2 or more.||3.3|-4.9|<0.001
71771208|NCT00645788|143042306|SUPERIORITY_OR_OTHER|||||||0.076|||||||ANCOVA|||"Ho: \|Cipro 32.5 mg - matching placebo\|=0 and \|Cipro 48.75 mg - matching placebo\|=0"||||0.076
71771209|NCT00645788|143042308|SUPERIORITY_OR_OTHER|||||||0.068|||||||ANCOVA|||"At visit 7 (End of treatment) Ho: \|Cipro 32.5 - matching placebo\| =0 and~\|Cipro 48.75 - matching placebo\| =0"||||0.068
71771210|NCT03149848|143042318|OTHER||Ratio|0.786|||||TWO_SIDED|90.0|0.743|0.831||||||||0.831|0.743|
71771211|NCT03149848|143042319|OTHER||Ratio|0.825|||||TWO_SIDED|90.0|0.761|0.895||||||||0.895|0.761|
71771212|NCT03149848|143042320|OTHER||Ratio|0.738|||||TWO_SIDED|90.0|0.702|0.776||||||||0.776|0.702|
71771213|NCT03149848|143042323|OTHER||Ratio|1.272|||||TWO_SIDED|90.0|1.204|1.345||||||||1.345|1.204|
71888732|NCT03430986|143298550|SUPERIORITY||Percentage difference|68.4|||<|0.0001|TWO_SIDED|95.0|50.0|82.4|||Fisher Exact|2-sided test comparing responder rate between treatment group and control group.||||82.4|50.0|<0.0001
71888733|NCT01078805|143298554|SUPERIORITY_OR_OTHER|||||||0.0177||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0177
71658535|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 2||||<0.0001
71771214|NCT01244490|143042341|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.9|||<|0.001|TWO_SIDED|95.0|-11.9|-5.8|||ANCOVA|||||-5.8|-11.9|<0.001
71771215|NCT01244490|143042341|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-3.8||||0.017|TWO_SIDED|95.0|-6.8|-0.7|||ANCOVA|||||-0.7|-6.8|0.017
71771216|NCT01244490|143042342|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|23.7|||<|0.001|TWO_SIDED|95.0|11.1|36.4|||Cochran-Mantel-Haenszel|||||36.4|11.1|<0.001
71771217|NCT01244490|143042342|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage Improvement|12.1||||0.024|TWO_SIDED|95.0|-0.9|25.1|||Cochran-Mantel-Haenszel|||||25.1|-0.9|0.024
71771218|NCT01244490|143042343|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.217||||0.003|TWO_SIDED|95.0|-0.358|-0.076|||ANCOVA|||||-0.076|-0.358|0.003
71771219|NCT01244490|143042343|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.162||||0.026|TWO_SIDED|95.0|-0.305|-0.019|||ANCOVA|||||-0.019|-0.305|0.026
71771220|NCT01244490|143042344|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.209||||0.006|TWO_SIDED|95.0|-0.358|-0.059|||ANCOVA|||||-0.059|-0.358|0.006
71771221|NCT01244490|143042344|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.09||||0.242|TWO_SIDED|95.0|-0.241|0.061|||ANCOVA|||||0.061|-0.241|0.242
71771222|NCT01244490|143042345|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||<0.001
71771223|NCT01244490|143042345|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel|||||||0.196
71771224|NCT01244490|143042347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.165||||0.001|TWO_SIDED|95.0|-0.266|-0.064||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.064|-0.266|0.001
71771225|NCT01244490|143042347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.104||||0.048|TWO_SIDED|95.0|-0.207|-0.001||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.001|-0.207|0.048
71771226|NCT01244490|143042348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.211||||0.043|TWO_SIDED|95.0|-0.416|-0.007||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.007|-0.416|0.043
71771227|NCT01244490|143042348|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.125||||0.231|TWO_SIDED|95.0|-0.331|0.08||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.080|-0.331|0.231
71771228|NCT01244490|143042349|SUPERIORITY_OR_OTHER_LEGACY||Diiference in Least Squares Mean|-0.229|||<|0.001|TWO_SIDED|95.0|-0.364|-0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.094|-0.364|<0.001
71888734|NCT01078805|143298554|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0019
71771229|NCT01244490|143042349|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.181||||0.009|TWO_SIDED|95.0|-0.317|-0.045||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.045|-0.317|0.009
71888735|NCT01078805|143298554|SUPERIORITY_OR_OTHER|||||||0.0143||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0143
71888736|NCT01078805|143298555|SUPERIORITY_OR_OTHER|||||||0.0689||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0689
71658536|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 2||||<0.0001
71728516|NCT00909545|142971889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.57||0.7049|TWO_SIDED|95.0|-1.36|0.92|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.||0.92|-1.36|0.7049
71728517|NCT00909545|142971890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19|STANDARD_ERROR_OF_MEAN|1.8||0.2278|TWO_SIDED|95.0|-1.4|5.79|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.79|-1.40|0.2278
71728518|NCT00909545|142971890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|1.86||0.356|TWO_SIDED|95.0|-1.97|5.42|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.||5.42|-1.97|0.356
71728519|NCT00909545|142971890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.83||0.26|TWO_SIDED|95.0|-1.56|5.71|||ANCOVA|||Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.||5.71|-1.56|0.2600
71728520|NCT00909545|142971897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2632|STANDARD_ERROR_OF_MEAN|1.159||0.1384|TWO_SIDED|95.0|0.5432|50.9977||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||50.9977|0.5432|0.1384
71728521|NCT00909545|142971897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.625|STANDARD_ERROR_OF_MEAN|1.097||0.0024|TWO_SIDED|95.0|1.8214|134.0403||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||134.0403|1.8214|0.0024
71728522|NCT00909545|142971897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|5.7004|438.5694||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.||438.5694|5.7004|<.0001
71728523|NCT00909545|142971898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.754|STANDARD_ERROR_OF_MEAN|0.6715||0.7735|TWO_SIDED|95.0|0.2022|2.812|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8120|0.2022|0.7735
71728524|NCT00909545|142971898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8143|STANDARD_ERROR_OF_MEAN|0.6419||0.7385|TWO_SIDED|95.0|0.2314|2.8658|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||2.8658|0.2314|0.7385
71728525|NCT00909545|142971898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9048|STANDARD_ERROR_OF_MEAN|0.6463||0.6823|TWO_SIDED|95.0|0.2549|3.2112|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.||3.2112|0.2549|0.6823
71728526|NCT00909545|142971899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5263|STANDARD_ERROR_OF_MEAN|0.9188||0.2756|TWO_SIDED|95.0|0.4172|15.2975|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||15.2975|0.4172|0.2756
71728527|NCT00909545|142971899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4211|STANDARD_ERROR_OF_MEAN|0.8584||0.07|TWO_SIDED|95.0|0.8217|23.7875|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||23.7875|0.8217|0.07
71728528|NCT00909545|142971899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|0.9174||0.2953|TWO_SIDED|95.0|0.3975|14.4919|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.||14.4919|0.3975|0.2953
71728529|NCT00909545|142971900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.8719||0.6049|TWO_SIDED|95.0|0.2082|6.3508|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||6.3508|0.2082|0.6049
71888737|NCT01078805|143298555|SUPERIORITY_OR_OTHER|||||||0.0412||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0412
71658537|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 2||||<0.0001
71728530|NCT00909545|142971900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.7704||0.2327|TWO_SIDED|95.0|0.5081|10.4105|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||10.4105|0.5081|0.2327
71728531|NCT00909545|142971900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.||7.6897|0.3057|0.4534
71728532|NCT00909545|142971901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||4.8065|0.1109|0.7852
71728533|NCT00909545|142971901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.8681||0.666|TWO_SIDED|95.0|0.1824|5.482|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||5.4820|0.1824|0.666
71728534|NCT00909545|142971901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5333|STANDARD_ERROR_OF_MEAN|0.8227||0.4534|TWO_SIDED|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.||7.6897|0.3057|0.4534
71771230|NCT01244490|143042350|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.094||||0.096|TWO_SIDED|95.0|-0.204|0.017||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.017|-0.204|0.096
71888738|NCT01078805|143298555|SUPERIORITY_OR_OTHER|||||||0.0631||95.0||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test|||||||0.0631
71771231|NCT01244490|143042350|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.067||||0.242|TWO_SIDED|95.0|-0.18|0.046||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.046|-0.180|0.242
71771232|NCT01244490|143042351|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.049||||0.5|TWO_SIDED|95.0|-0.191|0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.094|-0.191|0.500
71771233|NCT01244490|143042351|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.078||||0.288|TWO_SIDED|95.0|-0.222|0.066||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.066|-0.222|0.288
71771234|NCT01244490|143042352|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.233||||0.001|TWO_SIDED|95.0|-0.374|-0.092||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||-0.092|-0.374|0.001
71771235|NCT01244490|143042352|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.111||||0.124|TWO_SIDED|95.0|-0.253|0.031||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.031|-0.253|0.124
71771236|NCT01244490|143042353|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.056||||0.139|TWO_SIDED|95.0|-0.131|0.018||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.018|-0.131|0.139
71771237|NCT01244490|143042353|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-0.039||||0.315|TWO_SIDED|95.0|-0.115|0.037||Nominal p-value uncorrected for multiplicity.|ANCOVA|||||0.037|-0.115|0.315
71771238|NCT00971620|143042360|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|-2.0|4.0|||Wilcoxon rank sum test|||||4.00|-2.00|.70
71771239|NCT00971620|143042362|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon rank sum test|||||||.06
71771240|NCT00971620|143042363|SUPERIORITY_OR_OTHER|||||||0.007|||||||WIlcoxon rank sum test|||||||.007
71831098|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8856|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.09|0.8856
71771241|NCT00971620|143042364|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon rank sum test|||||||0.48
71771242|NCT00971620|143042365|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon rank sum test|||||||.04
71771243|NCT00971620|143042367|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon rank sum test|||||||.07
71771244|NCT01723696|143042386|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.19|TWO_SIDED|95.0|-6.1|30.3||P-value adjusted for design factors of site, gestational age at randomization and covariates of length, race, and sex of infant.|ANCOVA|||Our targeted sample size of 218 infants with successful FEFs at 3 months of age was determined to detect with 90% power, at a significance level of 0.05, increases of 15% in mean FEF75 in the vitamin C group compared to the placebo group.||30.3|-6.1|0.19
71771245|NCT02581943|143042389|OTHER|||||||0.366|||||||Log Rank|||||||0.366
71771246|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.327|||||||Wilcoxon (Mann-Whitney)|test for CD4+FoxP3||||||0.327
71771247|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.142|||||||Wilcoxon (Mann-Whitney)|test for MDSC||||||0.142
71831099|NCT02528188|143167426|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2814|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.05|0.2814
71771248|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.462||||||test for CD4+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.462
71771249|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.87||||||test for CD8+ICOS+|Wilcoxon (Mann-Whitney)|||||||0.870
71771250|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.414||||||test for Plamacytoid DC|Wilcoxon (Mann-Whitney)|||||||0.414
71771251|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.121||||||test for Monocytes|Wilcoxon (Mann-Whitney)|||||||0.121
71771252|NCT02581943|143042390|EQUIVALENCE|Null hypothesis: no difference between treatment arms in the post-pre difference in cell counts.||||||0.624||||||test for T cells (CD3+)|Wilcoxon (Mann-Whitney)|||||||0.624
71771253|NCT02581943|143042391|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
71771254|NCT02581943|143042392|OTHER|||||||0.63|||||||Log Rank|||||||0.63
71771255|NCT02581943|143042393|OTHER|||||||0.692|||||||Log Rank|||||||0.692
71771256|NCT02581943|143042394|OTHER|||||||0.345|||||||Fisher Exact|||||||0.345
71771257|NCT02581943|143042395|OTHER|||||||0.917|||||||Kruskal-Wallis|Test for CD8+ICOS||||||0.917
71771258|NCT02581943|143042395|OTHER|||||||0.746|||||||Kruskal-Wallis|test for MDSC||||||0.746
71771259|NCT02581943|143042395|OTHER|||||||0.302||||||test for CD4+ICOS|Kruskal-Wallis|||||||0.302
71771260|NCT02581943|143042395|OTHER|||||||0.13|||||||Kruskal-Wallis|test for CD8+ICOS+||||||0.130
71771261|NCT02581943|143042395|OTHER|||||||0.628||||||test for Plamacytoid DC|Kruskal-Wallis|||||||0.628
71771262|NCT02581943|143042395|OTHER|||||||0.567||||||test for Monocytes|Kruskal-Wallis|||||||0.567
71771263|NCT02581943|143042395|OTHER|||||||0.311||||||test for T cells (CD3+)|Kruskal-Wallis|||||||0.311
71771264|NCT02021656|143042406|SUPERIORITY||||||<|0.001|||||||Binomial Exact Test|||A sample size of 100 Chinese participants in the treatment naive group provided at least 90% power to detect a 17% improvement in SVR12 rate from the historical control rate of 57% using 2-sided exact one-sample binomial test at significant level of 0.05.||||<0.001
71771265|NCT02043379|143042434|NON_INFERIORITY_OR_EQUIVALENCE|We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
71771266|NCT02043379|143042435|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
71728535|NCT00909545|142971902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||6.4433|0.0462|0.8589
71728536|NCT00909545|142971902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5652|STANDARD_ERROR_OF_MEAN|0.9584||0.5|TWO_SIDED|95.0|0.2392|10.241|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||10.2410|0.2392|0.5000
71888739|NCT01078805|143298556|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71728537|NCT00909545|142971902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7143|STANDARD_ERROR_OF_MEAN|0.9605||0.4609|TWO_SIDED|95.0|0.2609|11.2639|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.||11.2639|0.2609|0.4609
71728538|NCT00909545|142971903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.8065|0.1109|0.7852
71728539|NCT00909545|142971903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||3.1612|0.0297|0.9448
71728540|NCT00909545|142971903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.697|STANDARD_ERROR_OF_MEAN|0.9604||0.7996|TWO_SIDED|95.0|0.1061|4.5779|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.||4.5779|0.1061|0.7996
71728541|NCT00909545|142971904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.381|STANDARD_ERROR_OF_MEAN|1.2599||0.4532|TWO_SIDED|95.0|0.2015|28.1366|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||28.1366|0.2015|0.4532
71728542|NCT00909545|142971904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9524|STANDARD_ERROR_OF_MEAN|1.1347||0.0953|TWO_SIDED|95.0|0.6439|55.0272|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.||55.0272|0.6439|0.0953
71728543|NCT00909545|142971905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402||95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||11.8558|0.2733|0.4402
71728544|NCT00909545|142971905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||5.6461|0.0408|0.8824
71728545|NCT00909545|142971905|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0909|STANDARD_ERROR_OF_MEAN|1.0428||0.6641|TWO_SIDED|95.0|0.1413|8.4197|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.||8.4197|0.1413|0.6641
71771267|NCT02043379|143042436|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.38
71658538|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 24||||<0.0001
71771268|NCT02043379|143042437|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.26||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||0.26
71771269|NCT02043379|143042438|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42|TWO_SIDED|95.0||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||24 hour post-CPB albumin||||0.42
71658539|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 24||||<0.0001
71728546|NCT00909545|142971906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||11.8558|0.2733|0.4402
71728547|NCT00909545|142971906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.||7.6906|0.1300|0.6951
71728548|NCT00909545|142971907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.9617||0.4402|TWO_SIDED|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||11.8558|0.2733|0.4402
71728549|NCT00909545|142971907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|1.2577||0.8824|TWO_SIDED|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||5.6461|0.0408|0.8824
71771270|NCT02043379|143042438|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||a p-value of \<0.05 represents the threshold for test signficance|t-test, 2 sided|||48 hour post CPB albumin||||0.06
71771271|NCT02043379|143042439|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.52
71888740|NCT01078805|143298557|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71888741|NCT03694392|143298600|OTHER||Hazard Ratio (HR)|0.85|||<|0.05|TWO_SIDED|95.0|0.76|0.94||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.3% (5.9%, 23.8%)|||0.94|0.76|<0.05
71888742|NCT03694392|143298601|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.65|1.09||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.9% (-9.2% to 35.2%)|||1.09|0.65|<0.05
71728550|NCT00909545|142971907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .||6.1537|0.0442|0.8673
71728551|NCT00909545|142971908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3485|STANDARD_ERROR_OF_MEAN|1.1919||0.9294|TWO_SIDED|95.0|0.0337|3.6084|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.6084|0.0337|0.9294
71728552|NCT00909545|142971908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.1612|0.0297|0.9448
71728553|NCT00909545|142971908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3333|STANDARD_ERROR_OF_MEAN|1.1924||0.9351|TWO_SIDED|95.0|0.0322|3.4459|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .||3.4459|0.0322|0.9351
71728554|NCT00909545|142971909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5455|STANDARD_ERROR_OF_MEAN|1.2596||0.8589|TWO_SIDED|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.4433|0.0462|0.8589
71728555|NCT00909545|142971909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0409||0.6951|TWO_SIDED|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||7.6906|0.1300|0.6951
71728556|NCT00909545|142971909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5217|STANDARD_ERROR_OF_MEAN|1.2594||0.8673|TWO_SIDED|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.||6.1537|0.0442|0.8673
71728557|NCT00909545|142971910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7302|STANDARD_ERROR_OF_MEAN|0.9616||0.7852|TWO_SIDED|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||4.8065|0.1109|0.7852
71728558|NCT00909545|142971910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3067|STANDARD_ERROR_OF_MEAN|1.1912||0.9448|TWO_SIDED|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.||3.1612|0.0297|0.9448
71728559|NCT00909545|142971911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||24.5057|0.1771|0.5000
71728560|NCT00909545|142971911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5714|STANDARD_ERROR_OF_MEAN|1.192||0.2746|TWO_SIDED|95.0|0.3453|36.9408|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.||36.9408|0.3453|0.2746
71771272|NCT02043379|143042440|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.81||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||Admit Inotrope Score||||0.81
71728561|NCT00909545|142971912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1364|STANDARD_ERROR_OF_MEAN|1.4444||0.7236|TWO_SIDED|95.0|0.067|19.264|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||19.2640|0.0670|0.7236
71728562|NCT00909545|142971912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0833|STANDARD_ERROR_OF_MEAN|1.2576||0.5|TWO_SIDED|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||24.5057|0.1771|0.5000
71728563|NCT00909545|142971912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2727|STANDARD_ERROR_OF_MEAN|1.2592||0.4694|TWO_SIDED|95.0|0.1926|26.8124|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.||26.8124|0.1926|0.4694
71728564|NCT02648022|142971923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91||||0.07|TWO_SIDED|95.0|0.92|9.27|||Regression, Linear|Multivariable Regression Analysis||||9.27|0.92|0.07
71728565|NCT00901511|142971937|SUPERIORITY||Median Difference (Final Values)|12.0||||0.0078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the median time to rescue WLL in the GM-CSF Group minus the median the time to rescue WLL in the Control Group|||||0.0078
71728566|NCT00901511|142971938|SUPERIORITY||Risk Ratio (RR)|7.0||||0.0152|TWO_SIDED|95.0|1.6|39.9|||Fisher Exact||Calculated as risk ratio of rescue WLL in the Control Group compared to the risk ratio of rescue WLL in the GM-CSF Group|||39.9|1.60|0.0152
71658540|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 24||||<0.0001
71658541|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 52||||<0.0001
71728567|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|9.5|||<|0.0001|TWO_SIDED|95.0|5.7|13.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean PaO2 in the GM-CSF Group minus the between group difference in mean PaO2 in the Control Group|||13.3|5.7|<0.0001
71728568|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|6.16||0.0261|TWO_SIDED|95.0|2.04|28.16|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.16|2.04|0.0261
71728569|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|9.56|STANDARD_ERROR_OF_MEAN|6.36||0.1521|TWO_SIDED|95.0|3.92|23.03|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||23.03|3.92|0.1521
71728570|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|18.04|STANDARD_ERROR_OF_MEAN|5.56||0.0051|TWO_SIDED|95.0|6.26|29.82|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||29.82|6.26|0.0051
71728571|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|20.26|STANDARD_ERROR_OF_MEAN|4.54||0.0004|TWO_SIDED|95.0|10.63|29.88|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||29.88|10.63|0.0004
71728572|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.89||0.0038|TWO_SIDED|95.0|7.43|32.4|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||32.40|7.43|0.0038
71728573|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|6.15||0.0149|TWO_SIDED|95.0|3.81|30.03|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||30.03|3.81|0.0149
71888743|NCT03694392|143298602|OTHER||Hazard Ratio (HR)|0.83|||<|0.05|TWO_SIDED|95.0|0.66|1.06||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 16.7% (-5.6% to 34.4%)|||1.06|0.66|<0.05
71658542|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 52||||<0.0001
71728574|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|19.02|STANDARD_ERROR_OF_MEAN|6.97||0.0148|TWO_SIDED|95.0|4.26|33.79|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||33.79|4.26|0.0148
71728575|NCT00901511|142971939|SUPERIORITY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|6.62||0.1158|TWO_SIDED|95.0|-3.02|25.02|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean PaO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean PaO2 in the GM-CSF Group minus the mean PaO2 in the Control Group|25.02|-3.02|0.1158
71728576|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.8|-5.4|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of A-aDO2 in the GM-CSF Group minus the mean value of A-aDO2 in the Control Group|Primary analysis||-5.4|-14.8|<0.0001
71728577|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-12.46|STANDARD_ERROR_OF_MEAN|6.0||0.0545|TWO_SIDED|95.0|-25.19|0.27|||t-test, 2 sided||Calculated as the difference at the pre-WLL visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.27|-25.19|0.0545
71728578|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-7.08|STANDARD_ERROR_OF_MEAN|6.34||0.2802|TWO_SIDED|95.0|-20.52|6.35|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||6.35|-20.52|0.2802
71728579|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
71771273|NCT02043379|143042440|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.82||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative inotrope score||||0.82
71728580|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-18.77|STANDARD_ERROR_OF_MEAN|4.91||0.0015|TWO_SIDED|95.0|-29.18|-8.36|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 3 -month visit after imputation of missing data using a last observation carried forward method.||-8.36|-29.18|0.0015
71728581|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-19.09|STANDARD_ERROR_OF_MEAN|5.85||0.0049|TWO_SIDED|95.0|-31.49|-6.7|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-6.70|-31.49|0.0049
71728582|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-15.85|STANDARD_ERROR_OF_MEAN|5.84||0.0152|TWO_SIDED|95.0|-28.23|-3.48|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-3.48|-28.23|0.0152
71728583|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-17.01|STANDARD_ERROR_OF_MEAN|6.27||0.0154|TWO_SIDED|95.0|-30.31|-3.71|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||-3.71|-30.31|0.0154
71728584|NCT00901511|142971940|SUPERIORITY||Mean Difference (Final Values)|-11.01|STANDARD_ERROR_OF_MEAN|6.15||0.0921|TWO_SIDED|95.0|-24.05|2.02|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean A-aDO2 in the GM-CSF Group minus the mean A-aDO2 in the Control Group|The secondary analysis includes evaluation of the difference in mean A-aDO2 between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.02|-24.05|0.0921
71728585|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.022|TWO_SIDED|95.0|1.9|21.3|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of the DLCO in the GM-CSF Group minus the mean value of the DLCO in the Control Group|Primary Analysis||21.3|1.9|0.0220
71728586|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|8.29|STANDARD_ERROR_OF_MEAN|7.96||0.3186|TWO_SIDED|95.0|-9.06|25.63|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||25.63|-9.06|0.3186
71728587|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|5.56|STANDARD_ERROR_OF_MEAN|6.58||0.4111|TWO_SIDED|95.0|-8.4|19.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||19.51|-8.40|0.4111
71728588|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|12.89|STANDARD_ERROR_OF_MEAN|6.53||0.0658|TWO_SIDED|95.0|-0.95|26.73|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||26.73|-0.95|0.0658
71728589|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|9.78|STANDARD_ERROR_OF_MEAN|7.81||0.2287|TWO_SIDED|95.0|-6.78|26.34|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||26.34|-6.78|0.2287
71728590|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|8.37||0.1432|TWO_SIDED|95.0|-4.86|30.64|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||30.64|-4.86|0.1432
71771274|NCT02043379|143042440|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.9||||||a p value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative inotrope score||||0.9
71831100|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4691|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.28|0.89|0.4691
71771275|NCT02043379|143042440|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.23||||||a p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||48 hours post-operative inotrope score||||0.23
71831101|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5451|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2||1.13|0.79|0.5451
71658543|NCT01941940|142832125|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 52||||<0.0001
71658544|NCT01941940|142832126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 2||||<0.0001
71728591|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|11.78|STANDARD_ERROR_OF_MEAN|8.47||0.1833|TWO_SIDED|95.0|-6.17|29.73|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||29.73|-6.17|0.1833
71728592|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|12.67|STANDARD_ERROR_OF_MEAN|9.23||0.1888|TWO_SIDED|95.0|-6.9|32.23|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.23|-6.90|0.1888
71728593|NCT00901511|142971941|SUPERIORITY||Mean Difference (Final Values)|4.22|STANDARD_ERROR_OF_MEAN|8.79||0.6374|TWO_SIDED|95.0|-14.41|22.85|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean DLCO in the GM-CSF Group minus the mean DLCO in the Control Group|The secondary analysis includes evaluation of the difference in mean DLCO between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||22.85|-14.41|0.6374
71728594|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.532|TWO_SIDED|95.0|-5.3|9.9|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|Primary Analysis||9.90|-5.30|0.5320
71728595|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|7.55||0.6772|TWO_SIDED|95.0|-13.09|19.52|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||19.52|-13.09|0.6772
71728596|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|6.7||0.832|TWO_SIDED|95.0|-12.52|15.64|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||15.64|-12.52|0.8320
71728597|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|7.82||0.8532|TWO_SIDED|95.0|-15.19|18.14|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||18.14|-15.19|0.8532
71771276|NCT02043379|143042441|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.49||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.49
71658545|NCT01941940|142832126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 24||||<0.0001
71728598|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|7.66||0.7752|TWO_SIDED|95.0|-14.0|18.44|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||18.44|-14.00|0.7752
71728599|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|5.74|STANDARD_ERROR_OF_MEAN|8.65||0.5174|TWO_SIDED|95.0|-12.7|24.18|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean value of VC in the GM-CSF Group minus the mean value of VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||24.18|-12.70|0.5174
71728600|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|3.67|STANDARD_ERROR_OF_MEAN|7.68||0.6393|TWO_SIDED|95.0|-12.61|19.94|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||19.94|-12.61|0.6393
71728601|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|5.22|STANDARD_ERROR_OF_MEAN|8.26||0.5361|TWO_SIDED|95.0|-12.28|22.73|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|The secondary analysis includes evaluation of the difference in mean VC between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||22.73|-12.28|0.5361
71728602|NCT00901511|142971942|SUPERIORITY||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|7.04||0.8159|TWO_SIDED|95.0|-13.26|16.6|||t-test, 2 sided|||The secondary analysis includes evaluation of the difference in mean VC between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.|Calculated as the difference at the 30-month visit in the mean VC in the GM-CSF Group minus the mean VC in the Control Group|16.60|-13.26|0.8159
71771277|NCT02043379|143042442|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.79
71771278|NCT02043379|143042443|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.32||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative IgG level||||0.32
71658546|NCT01941940|142832126|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 52||||<0.0001
71771279|NCT02043379|143042443|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation||||||0.36||||||a p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative IgG level||||0.36
71658547|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 2||||<0.0001
71771280|NCT02043379|143042443|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||post-operative day 3 (72 hours) IgG level||||<0.01
71771281|NCT02043379|143042443|NON_INFERIORITY_OR_EQUIVALENCE|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||post-operative day 5 (120 hours) IgG level||||<0.01
71771282|NCT02043379|143042444|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.6||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.60
71771283|NCT02043379|143042444|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.06
71771284|NCT02043379|143042444|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.06
71771285|NCT02043379|143042444|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.33||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative||||0.33
71771286|NCT02043379|143042444|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.05||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative||||0.05
71771287|NCT02043379|143042444|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.83||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hours post-operative||||0.83
71658548|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 2||||<0.0001
71658549|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 2||||<0.0001
71658550|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 24||||<0.0001
71658551|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 24||||<0.0001
71658552|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 24||||<0.0001
71658553|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 52||||<0.0001
71658554|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 52||||<0.0001
71658555|NCT01941940|142832127|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 52||||<0.0001
71771288|NCT02043379|143042445|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour levels||||0.27
71771289|NCT02043379|143042445|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.34
71831102|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0059|TWO_SIDED|95.0|1.08|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.54|1.08|0.0059
71658556|NCT01941940|142832128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 2||||<0.0001
71658557|NCT01941940|142832128|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 24||||<0.0001
71658558|NCT01941940|142832128|SUPERIORITY_OR_OTHER|||||||0.0016|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 52||||0.0016
71658559|NCT01941940|142832131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658560|NCT01941940|142832131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658561|NCT01941940|142832131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658562|NCT01941940|142832132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658563|NCT01941940|142832132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658564|NCT01941940|142832132|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71771290|NCT02043379|143042445|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.14
71771291|NCT02043379|143042445|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.13||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.13
71888744|NCT03694392|143298603|OTHER||Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.08||Adjustment for multiplicity for the secondary outcomes was performed with the use of Holm's adjustment method.|Regression, Cox|Models were adjusted for age, age squared, sex, and race or ethnic group after weighting with stabilized facility-specific propensity scores.|Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 2.4% (-8.1% to 11.9%)|||1.08|0.88|<0.05
71888745|NCT03694392|143298604|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.75|1.8|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -15.7% (-79.5% to 25.5%)|||1.80|0.75|<0.05
71888746|NCT03694392|143298605|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.95|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.0% to 5.4%)|||1.06|0.95|<0.05
71658565|NCT01941940|142832133|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658566|NCT01941940|142832133|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658567|NCT01941940|142832133|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658568|NCT01941940|142832134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658569|NCT01941940|142832134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658570|NCT01941940|142832134|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658571|NCT01941940|142832136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658572|NCT01941940|142832136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658573|NCT01941940|142832136|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||<0.0001
71658574|NCT01941940|142832137|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.0045
71658575|NCT01941940|142832137|SUPERIORITY_OR_OTHER|||||||0.1992|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.||||0.1992
71658576|NCT00513682|142832145|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||t-test, 1 sided|||||||0.0013
71658577|NCT00513682|142832146|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 1 sided|||||||0.0009
71658578|NCT01565616|142832154|OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|10.4||0.52|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the anxiety domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.52
71658579|NCT01565616|142832154|OTHER||Mean Difference (Net)|2.7|STANDARD_DEVIATION|6.4||0.12|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the depression domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.12
71658580|NCT01565616|142832154|OTHER||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|8.5||0.54|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the fatigue domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.54
71658581|NCT01565616|142832154|OTHER||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|9.3||0.006|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the pain interference domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.006
71658582|NCT01565616|142832154|OTHER||Mean Difference (Net)|5.8|STANDARD_DEVIATION|10.5||0.044|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the physical function domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.044
71658583|NCT01565616|142832154|OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|11.8||0.85|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the satisfaction with social role domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.85
71658584|NCT01565616|142832154|OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|13.5||0.88|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the sleep disturbances domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.88
71658585|NCT01565616|142832154|OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.1||0.53|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is the paired difference in raw scores of the pain intensity domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.||||0.53
71771292|NCT02043379|143042445|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.02
71728603|NCT00901511|142971943|SUPERIORITY||Mean Difference (Final Values)|-0.822||||0.053|TWO_SIDED|95.0|-1.7|0.01|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the median value of the GGO Score in the GM-CSF Group minus the median value of the GGO Score in the Control Group|Primary Analysis||0.01|-1.70|0.0530
71831103|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0057|TWO_SIDED|95.0|1.08|1.55|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4||1.55|1.08|0.0057
71658586|NCT01121666|142832174|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED|||||This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.|Shuirmann's TOST|||This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.||||0.0003
71658587|NCT01121666|142832175|SUPERIORITY_OR_OTHER|||||||0.2357|TWO_SIDED|||||Follicles of 12 mm|Wilcoxon (Mann-Whitney)|||||||0.2357
71658588|NCT01121666|142832175|SUPERIORITY_OR_OTHER|||||||0.1395|TWO_SIDED|||||Follicles of 15 mm|Wilcoxon (Mann-Whitney)|||||||0.1395
71658589|NCT01121666|142832175|SUPERIORITY_OR_OTHER|||||||0.3992|TWO_SIDED|||||Follicles of 17 mm|Wilcoxon (Mann-Whitney)|||||||0.3992
71658590|NCT01121666|142832177|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9638
71658591|NCT01121666|142832182|SUPERIORITY_OR_OTHER|||||||0.8926|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8926
71658592|NCT01121666|142832189|NON_INFERIORITY_OR_EQUIVALENCE|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|TWO_SIDED||||||Shuirmann's TOST|||||||0.0003
71658593|NCT03176459|142832197|SUPERIORITY||LSM treatment difference|-16.5||||0.0117|TWO_SIDED|95.0|-30.8|-2.2|||ANCOVA|||||-2.2|-30.8|0.0117
71658594|NCT03176459|142832198|NON_INFERIORITY|Pre-specified non-inferiority margin of 36|LSM treatment difference (SE)|-30.6||||0.002|TWO_SIDED|95.0|-75.9|14.7|||ANCOVA|||||14.7|-75.9|0.0020
71658595|NCT03176459|142832199|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0012|TWO_SIDED|95.0|1.557|7.906|||LSM probability from logistic regression|||||7.906|1.557|0.0012
71658596|NCT03176459|142832200|SUPERIORITY||Least squares treatment difference|-3.2||||0.0543|TWO_SIDED||||||ANCOVA|||||||.0543
71658597|NCT03176459|142832201|SUPERIORITY||Least squares treatment difference|-11.4||||0.0096|ONE_SIDED||||||ANCOVA|||||||.0096
71658598|NCT03176459|142832202|SUPERIORITY||Least squares treatment difference|-22.4||||0.0175|TWO_SIDED||||||ANCOVA|||||||.0175
71831104|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1584|TWO_SIDED|95.0|0.95|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.38|0.95|0.1584
71658599|NCT03176459|142832203|SUPERIORITY||Least squares treatment difference|-19.6||||0.0542|TWO_SIDED||||||ANCOVA|||||||.0542
71658600|NCT03176459|142832204|SUPERIORITY|||||||0.7536|||||||Regression, Cox|||||||0.7536
71658601|NCT03176459|142832205|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3609|TWO_SIDED||||||Regression, Logistic|||||||0.3609
71658602|NCT01461226|142832253|OTHER|Mixed models analysis|mixed models|0.04|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71658603|NCT01461226|142832253|OTHER||mixed models|0.24||||0.64|TWO_SIDED|||||Baseline difference between groups|Mixed Models Analysis|||||||0.64
71658604|NCT01461226|142832253|OTHER|Mixed models|Slope|0.27||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
71658605|NCT01461226|142832253|OTHER|mixed models|mixed models|4.2||||0.04|TWO_SIDED||||||Mixed Models Analysis|||change after 10 months between groups||||0.04
71658606|NCT04763564|142832256|SUPERIORITY||||||<|0.03||||||A priori threshold for significance was \< 0.05. Significance level liraglutide vs. placebo in percent reduction of bowel frequency at week 4 vs. baseline.|Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||<0.03
71658607|NCT04763564|142832259|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The 2 treatment modalities, Liraglutide and Placebo, were compared. A repeated-measures mixed model was fitted to the data, with treatment (liraglutide or placebo), period, and treatment sequence as fixed effects and the repeated measures within the subject as a random effect.||||0.01
71658608|NCT00852969|142832334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.71|TWO_SIDED|95.0|-10.79|7.41|||t-test, 2 sided|||||7.41|-10.79|0.71
71658609|NCT00852969|142832335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.48||||0.29|TWO_SIDED|95.0|-7.2|2.24|||t-test, 2 sided|||||2.24|-7.20|0.29
71658610|NCT02440022|142832346|SUPERIORITY|||||||0.0562|||||||Kaplan-Meier|||||||0.0562
71658611|NCT02440022|142832347|NON_INFERIORITY|Where δ = 10% is the non-inferiority margin, which is the range of difference that is considered not clinically important. A non-inferiority Farrington and Manning Test was used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. In addition to the p-value of the test, the confidence intervals of the rate in each group and the difference between the two groups is calculated.||||||0.002|||||||Binary Analysis|||"H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 \> p2 - δ)"||||0.002
71658612|NCT02440022|142832353|OTHER|||||||0.716||||||P-value was type 3 test of the interaction of treatment group and pre-dilation balloon type.|Regression, Cox|||||||0.7160
71658613|NCT02358343|142832363|SUPERIORITY|||||||0.77||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood ratio test obtained from logistic regression analysis adjusting for site||||||0.77
71888747|NCT03694392|143298606|OTHER||Hazard Ratio (HR)|1.8|||<|0.05|TWO_SIDED|95.0|-2.2|5.5|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 1.8% (-2.2% to 5.5%)|||5.5|-2.2|<0.05
71661147|NCT00191113|142835871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.001||95.0|0.9|1.2|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interactions terms removed when not significant.|"Effect direction is As-Treated Growth Hormone minus As-Treated No Growth Hormone"|Estimation analysis of the magnitude of effect of treatment with growth hormone upon Final Height. Null hypothesis is no effect of growth hormone upon attained height standard deviation score (National Center for Health Statistics).||1.2|0.9|<0.001
71728604|NCT00901511|142971943|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||>0.9999
71728605|NCT00901511|142971943|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0332|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0332
71728606|NCT00901511|142971943|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0676|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0676
71728607|NCT00901511|142971943|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.0629|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0629
71728608|NCT00901511|142971943|SUPERIORITY||Median Difference (Final Values)|0.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median GGO Score in the GM-CSF Group minus the median GGO Score in the Control Group|The secondary analysis includes evaluation of the difference in median GGO Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
71728609|NCT00901511|142971944|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.001|TWO_SIDED|95.0|-0.71|-0.22|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the CEA levels in the GM-CSF Group minus the CEA levels in the Control Group|Primary Analysis||-0.22|-0.71|0.0010
71728610|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-12.0||||0.0059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0059
71728611|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-3.45||||0.0382|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0382
71728612|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.0770
71728613|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-4.0||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.0400
71771293|NCT02043379|143042446|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Chi-squared|||||||1
71771294|NCT02043379|143042447|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4
71771295|NCT02043379|143042448|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.09||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-48 hours post-CPB||||0.09
71771296|NCT02043379|143042448|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-24 hours post CPB||||0.52
71771297|NCT02043379|143042449|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.72||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.72
71771298|NCT02043379|143042450|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.63||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.63
71771299|NCT02043379|143042451|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.41||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.41
71728614|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-7.9||||0.0142|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.0142
71728615|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-6.5||||0.0071|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.0071
71888748|NCT03694392|143298607|OTHER||Hazard Ratio (HR)|9.4|||<|0.05|TWO_SIDED|95.0|-5.4|22.1|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 9.4% (-5.4% to 22.1%)|||22.1|-5.4|<0.05
71888749|NCT03694392|143298608|OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.86|1.02|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 6.2% (-2.2% to 13.9%)|||1.02|0.86|<0.05
71658614|NCT02358343|142832364|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.035|TWO_SIDED|95.0|-3.54|-0.13||a priori threshold for significance is 0.05.|Wald Test|The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.|The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT).|All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.||-0.13|-3.54|0.035
71658615|NCT02358343|142832365|SUPERIORITY|||||||0.96||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood Ratio Test from logistic regression analysis adjusting for clinical site.||||||0.96
71658616|NCT02358343|142832366|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-7.4|-0.02|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.02|-7.4|
71658617|NCT02358343|142832367|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.1|0.8|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.8|-3.1|
71658618|NCT02358343|142832368|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-6.2|-0.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||-0.1|-6.2|
71658619|NCT02358343|142832369|SUPERIORITY||Mean Difference (Final Values)|10.2|||||TWO_SIDED|95.0|1.3|19.0|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||19.0|1.3|
71658620|NCT02358343|142832370|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.2|1.4|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||1.4|-0.2|
71658621|NCT02358343|142832371|SUPERIORITY||Mean Difference (Final Values)|2.6|||||TWO_SIDED|95.0|0.1|5.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||5.1|0.1|
71658622|NCT02358343|142832372|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.5|0.5|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.5|-0.5|
71658623|NCT02358343|142832374|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.5|0.7|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.7|-0.5|
71658624|NCT02358343|142832375|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.55|1.1|||||The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator).|||1.10|0.55|
71658625|NCT02358343|142832376|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.54|0.34|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.34|-0.54|
71658626|NCT02358343|142832377|SUPERIORITY||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.25|0.75|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).|||0.75|-0.25|
71658627|NCT01951885|142832410|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|47 patients per arm were needed to detect a 25% improvement in mucositis based on a one-sided test with 5% significance and 80% power.||||||0.05
71658628|NCT01951885|142832413|NON_INFERIORITY|Cumulative incidence methods are compared using the Gray test with a p-value \<0.05|||||<|0.05|||||||Log Rank|||||||<0.05
71658629|NCT01951885|142832414|NON_INFERIORITY|Hospital stay will be compared between groups using the Wilcoxon rank sum test with a p value of 0.05.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71658630|NCT01951885|142832415|NON_INFERIORITY|TPN use will be compared using the Chi-square test.|||||<|0.05|||||||Chi-squared|||||||<0.05
71658631|NCT01951885|142832416|NON_INFERIORITY|Overall survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
71728616|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-5.6||||0.0137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.0137
71728617|NCT00901511|142971944|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.0315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum CEA levels in the GM-CSF Group minus the median serum CEA levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum CEA levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.0315
71728618|NCT00901511|142971945|SUPERIORITY||Mean Difference (Final Values)|-3689.0||||0.03|TWO_SIDED|95.0|-6972.0|-406.0|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the between group difference in the KL-6 levels in the GM-CSF Group minus the KL-6 levels in the Control Group|Primary Analysis||-406|-6972|0.0300
71728619|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-3265.0||||0.077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.0770
71728620|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-5018.0||||0.0745|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.0745
71728621|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-6343.0||||0.2581|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.2581
71728622|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-4102.0||||0.4894|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.4894
71728623|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-6818.0|||>|0.9999|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||>0.9999
71771300|NCT02043379|143042451|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.34
71771301|NCT02043379|143042451|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.47
71771302|NCT02043379|143042451|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.42
71888750|NCT03694392|143298609|OTHER||Hazard Ratio (HR)|1.07|||<|0.05|TWO_SIDED|95.0|0.75|1.52|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -6.9% (-51.6% to 24.6%)|||1.52|0.75|<0.05
71658632|NCT01951885|142832417|NON_INFERIORITY|Progression-free survival was estimated using the Kaplan-Meier method and compared between patients receiving Tac/MTX versus Tac/mini-MTX/MMF using the log-rank test|||||<|0.05|||||||Log Rank|||||||<0.05
71728624|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-1570.0||||0.8633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.8633
71771303|NCT02043379|143042451|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.82
71771304|NCT02043379|143042451|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.44||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.44
71771305|NCT02043379|143042452|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.28||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.28
71771306|NCT02043379|143042452|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.37
71771307|NCT02043379|143042452|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.42
71771308|NCT02043379|143042452|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.31||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.31
71728625|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-4200.0||||0.3401|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 18-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.3401
71728626|NCT00901511|142971945|SUPERIORITY||Median Difference (Final Values)|-4307.0||||0.2973|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum KL-6 levels in the GM-CSF Group minus the median KL-6 levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum KL-6 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.2973
71728627|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.22|TWO_SIDED|95.0|-0.44|-0.04|||Repeated measures ANOVA||Calculated as the between group difference in the serum Cyfra21.1 levels in the GM-CSF Group minus the serum Cyfra21.1 levels in the Control Group|Primary Analysis||-0.04|-0.44|0.220
71728628|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-14.19|STANDARD_ERROR_OF_MEAN|6.76||0.056|TWO_SIDED|95.0|-28.8|0.42|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|•The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.42|-28.80|0.0560
71658633|NCT01951885|142832420|NON_INFERIORITY|Infusion times will be compared using the Wilcoxon rank sum test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71658634|NCT01951885|142832421|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71658635|NCT01951885|142832422|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71658636|NCT01951885|142832423|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Chi-squared|||||||<0.05
71658637|NCT01951885|142832424|NON_INFERIORITY|100-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71658638|NCT01951885|142832426|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71658639|NCT01951885|142832427|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71658640|NCT01951885|142832428|NON_INFERIORITY|180-day incidence of complications will be compared using the Gray test.|||||<|0.05|||||||Gray Test|||||||<0.05
71658641|NCT00866658|142832431|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-1.116|-0.65||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%),sulfonylurea use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t test at 5% significance level.||-0.650|-1.116|<0.0001
71658642|NCT01687478|142832449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.62|||||TWO_SIDED|95.0|-5.04|1.8|||||The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.|||1.80|-5.04|
71658643|NCT01276301|142832458|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.95|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|90.0|98.87|107.02|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||107.02|98.87|
71658644|NCT01276301|142832459|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|92.39|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|85.38|99.97|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||99.97|85.38|
71658645|NCT01276301|142832460|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.77|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|90.0|98.87|106.83|||ANOVA|Based on ANOVA with fixed terms for sequence, period, treatment and random term for subject within sequence.|Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa||106.83|98.87|
71658646|NCT01462318|142832489|SUPERIORITY_OR_OTHER||ratio|1.015|||||TWO_SIDED|90.0|0.894|1.153|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.153|0.894|
71658647|NCT01462318|142832489|SUPERIORITY_OR_OTHER||ratio|1.005|||||TWO_SIDED|90.0|0.951|1.063|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.063|0.951|
71658648|NCT01462318|142832489|SUPERIORITY_OR_OTHER||ratio|0.996|||||TWO_SIDED|90.0|0.88|1.127|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.127|0.880|
71658649|NCT01462318|142832489|SUPERIORITY_OR_OTHER||ratio|1.032|||||TWO_SIDED|90.0|0.93|1.145|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of maximum observed concentration \[Cmax\]).||1.145|0.930|
71658650|NCT01462318|142832490|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.764|1.342|||||test/reference = dextromethorphan+DAC HYP/dextromethorphan|Pairwise comparison: dextromethorphan. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.342|0.764|
71658651|NCT01462318|142832498|SUPERIORITY_OR_OTHER||ratio|1.079|||||TWO_SIDED|90.0|0.912|1.276|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.276|0.912|
71661148|NCT00191113|142835872|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.001||95.0|0.9|1.3|||ANCOVA|||||1.3|0.9|<0.001
71728629|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.15||0.0648|TWO_SIDED|95.0|-8.8|0.29|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||0.29|-8.80|0.0648
71728630|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|2.36||0.0175|TWO_SIDED|95.0|-11.28|-1.25|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||-1.25|-11.28|0.0175
71771309|NCT02043379|143042452|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.38
71771310|NCT02043379|143042452|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.4||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.4
71771311|NCT02043379|143042453|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
71771312|NCT02043379|143042453|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.12||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.12
71771313|NCT02043379|143042453|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.51||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.51
71771314|NCT02043379|143042453|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.27
71728631|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-16.81|STANDARD_ERROR_OF_MEAN|6.16||0.0148|TWO_SIDED|95.0|-29.85|-3.76|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||-3.76|-29.85|0.0148
71728632|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-5.41|STANDARD_ERROR_OF_MEAN|1.82||0.0089|TWO_SIDED|95.0|-9.27|-1.56|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||-1.56|-9.27|0.0089
71771315|NCT02043379|143042453|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.88||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.88
71888751|NCT03694392|143298610|OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 5.2% (-18.8% to 24.4%)|||1.12|0.76|<0.05
71771316|NCT02043379|143042453|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
71771317|NCT02043379|143042454|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.35
71771318|NCT02043379|143042454|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.39||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.39
71771319|NCT02043379|143042454|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.58||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.58
71771320|NCT02043379|143042454|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.36||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.36
71771321|NCT02043379|143042454|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.61||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.61
71771322|NCT02043379|143042454|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.38
71771323|NCT02043379|143042455|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.1
71771324|NCT02043379|143042455|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.02
71771325|NCT02043379|143042455|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.34
71888752|NCT03694392|143298611|OTHER||Hazard Ratio (HR)|0.89|||<|0.05|TWO_SIDED|95.0|0.85|0.93|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.8% (6.6% to 14.7%)|||0.93|0.85|<0.05
71728633|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|2.24||0.0343|TWO_SIDED|95.0|-9.92|-0.43|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||-0.43|-9.92|0.0343
71728634|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|2.33||0.0871|TWO_SIDED|95.0|-9.21|0.69|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||0.69|-9.21|0.0871
71728635|NCT00901511|142971946|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.4||0.2265|TWO_SIDED|95.0|-8.09|2.06|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean serum Cyfra21.1 levels in the GM-CSF Group minus the mean serum Cyfra21.1 levels in the Control Group|The secondary analysis includes evaluation of the difference in mean serum Cyfra21.1 levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||2.06|-8.09|0.2265
71728636|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|8.78||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the Pre-WLL visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||||0.3865
71728637|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|7.82||||0.1672|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the baseline visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||||0.1672
71728638|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|4.24||||0.4363|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 1-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||||0.4363
71728639|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|7.34||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 3-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
71728640|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|13.71||||0.1615|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 6-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||||0.1615
71888753|NCT03694392|143298612|OTHER||Hazard Ratio (HR)|1.001|||<|0.05|TWO_SIDED|95.0|0.94|1.06|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -0.1% (-6.2% to 5.6%)|||1.06|0.94|<0.05
71728641|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|11.1||||0.3865|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 10-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||||0.3865
71728642|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|5.4||||0.6475|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||• Calculated as the difference at the 18-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||||0.6475
71728643|NCT00901511|142971947|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.6481|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Calculated as the difference at the 30-month visit in the median serum GMAb levels in the GM-CSF Group minus the median serum GMAb levels in the Control Group|The secondary analysis includes evaluation of the difference in median serum GMAb levels between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||||0.6481
71728644|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.78||0.0582|TWO_SIDED|95.0|-3.17|0.06|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||0.06|-3.17|0.0582
71771326|NCT02043379|143042455|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.35||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.35
71771327|NCT02043379|143042455|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.67||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.67
71771328|NCT02043379|143042455|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.47
71728645|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|1.09||0.3068|TWO_SIDED|95.0|-1.17|3.48|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||3.48|-1.17|0.3068
71728646|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.75||0.5647|TWO_SIDED|95.0|-2.04|1.15|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||1.15|-2.04|0.5647
71728647|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.59||0.1669|TWO_SIDED|95.0|-2.11|0.4|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||0.40|-2.11|0.1669
71728648|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.69||0.453|TWO_SIDED|95.0|-1.99|0.93|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||0.93|-1.99|0.4530
71728649|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.71||0.4594|TWO_SIDED|95.0|-2.04|0.97|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||0.97|-2.04|0.4594
71728650|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.6302|TWO_SIDED|95.0|-1.61|1.0|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||1.00|-1.61|0.6302
71728651|NCT00901511|142971948|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.24|0.8|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean WBC count in the GM-CSF Group minus the mean WBC count in the Control Group|The secondary analysis includes evaluation of the difference in mean WBC counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||0.80|-2.24|0.3300
71728652|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-53.72|STANDARD_ERROR_OF_MEAN|38.79||0.1864|TWO_SIDED|95.0|-136.4|28.96|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||28.96|-136.4|0.1864
71728653|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-21.17|STANDARD_ERROR_OF_MEAN|46.3||0.6541|TWO_SIDED|95.0|-119.8|77.51|||t-test, 2 sided||Calculated as the difference at the baseline visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the baseline visit after imputation of missing data using a last observation carried forward method.||77.51|-119.8|0.6541
71771329|NCT02043379|143042456|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.46||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative||||0.46
71771330|NCT02043379|143042456|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative||||0.04
71728654|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-18.78|STANDARD_ERROR_OF_MEAN|24.58||0.456|TWO_SIDED|95.0|-70.89|33.33|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||33.33|-70.89|0.4560
71771331|NCT02043379|143042456|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative||||0.14
71771332|NCT02043379|143042456|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative||||0.82
71888754|NCT03694392|143298613|OTHER||Hazard Ratio (HR)|1.46|||<|0.05|TWO_SIDED|95.0|1.06|2.0|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -45.5% (-100.2% to -5.8%)|||2.00|1.06|<0.05
71888755|NCT03694392|143298614|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.82|0.99|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.2% (1.4% to 18.2%)|||0.99|0.82|<0.05
71771333|NCT02043379|143042456|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.9||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative||||0.9
71888756|NCT03694392|143298615|OTHER||Hazard Ratio (HR)|1.16|||<|0.05|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: -16.2% (-43.0% to 5.5%)|||1.43|0.95|<0.05
71728655|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-28.44|STANDARD_ERROR_OF_MEAN|30.98||0.3721|TWO_SIDED|95.0|-94.12|37.23|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||37.23|-94.12|0.3721
71728656|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-28.78|STANDARD_ERROR_OF_MEAN|20.58||0.1812|TWO_SIDED|95.0|-72.41|14.86|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||14.86|-72.41|0.1812
71728657|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-26.11|STANDARD_ERROR_OF_MEAN|23.38||0.2805|TWO_SIDED|95.0|-75.67|23.44|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||23.44|-75.67|0.2805
71728658|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-27.33|STANDARD_ERROR_OF_MEAN|22.75||0.247|TWO_SIDED|95.0|-75.56|20.89|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||20.89|-75.56|0.2470
71728659|NCT00901511|142971949|SUPERIORITY||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|23.57||0.207|TWO_SIDED|95.0|-80.97|18.97|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean platelet count in the GM-CSF Group minus the mean platelet count in the Control Group|The secondary analysis includes evaluation of the difference in mean platelet counts between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||18.97|-80.97|0.2070
71728660|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.149|TWO_SIDED|95.0|-1.88|11.33|||Repeated measures ANOVA|Data was evaluated via repeated measures ANOVA after adjustment for baseline values, gender, age, and number of patients at risk at each time point.|Calculated as the difference in the mean value of the SF-36 General Health Score in the GM-CSF Group minus the Control Group|Primary analysis||11.33|-1.88|0.1490
71728661|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|-4.31|STANDARD_ERROR_OF_MEAN|12.07||0.7263|TWO_SIDED|95.0|-30.04|21.43|||t-test, 2 sided||Calculated as the difference at the Pre-WLL visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the Pre-WLL visit after imputation of missing data using a last observation carried forward method.||21.43|-30.04|0.7263
71728662|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|8.29||0.3298|TWO_SIDED|95.0|-9.24|25.91|||t-test, 2 sided||Calculated as the difference at the 1-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 1-month visit after imputation of missing data using a last observation carried forward method.||25.91|-9.24|0.3298
71728663|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|13.89|STANDARD_ERROR_OF_MEAN|6.48||0.0478|TWO_SIDED|95.0|-0.15|27.62|||t-test, 2 sided||Calculated as the difference at the 3-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in SF-36 General Health Score between groups at the 3-month visit after imputation of missing data using a last observation carried forward method.||27.62|-0.15|0.0478
71728664|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|17.78|STANDARD_ERROR_OF_MEAN|7.37||0.0281|TWO_SIDED|95.0|2.16|33.39|||t-test, 2 sided||Calculated as the difference at the 6-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 6-month visit after imputation of missing data using a last observation carried forward method.||33.39|2.16|0.0281
71728665|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|11.67|STANDARD_ERROR_OF_MEAN|10.07||0.2634|TWO_SIDED|95.0|-9.67|33.0|||t-test, 2 sided||Calculated as the difference at the 10-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 10-month visit after imputation of missing data using a last observation carried forward method.||33.00|-9.67|0.2634
71728666|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|10.49||0.3548|TWO_SIDED|95.0|-12.24|32.24|||t-test, 2 sided||Calculated as the difference at the 18-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 18-month visit after imputation of missing data using a last observation carried forward method.||32.24|-12.24|0.3548
71728667|NCT00901511|142971950|SUPERIORITY||Mean Difference (Final Values)|16.67|STANDARD_ERROR_OF_MEAN|9.68||0.1043|TWO_SIDED|95.0|-3.85|37.18|||t-test, 2 sided||Calculated as the difference at the 30-month visit in the mean SF-36 General Health Score in the GM-CSF Group minus the mean SF-36 General Health Score in the Control Group|The secondary analysis includes evaluation of the difference in mean SF-36 General Health Score between groups at the 30-month visit after imputation of missing data using a last observation carried forward method.||37.18|-3.85|0.1043
71728668|NCT02880514|142971997|SUPERIORITY|||||||0.0391||||||P-value not adjusted for multiplicity.|McNemar|McNemar's exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.||||||0.0391
71728669|NCT02880514|142971998|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71831105|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.3||||0.006||95.0|1.08|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8||1.58|1.08|0.0060
71831106|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1117|TWO_SIDED|95.0|0.96|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.46|0.96|0.1117
71728670|NCT02436668|142971999|SUPERIORITY||Hazard Ratio (HR)|1.525|||<|0.0001|TWO_SIDED|95.0|1.241|1.873||P-value is from log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.873|1.241|<0.0001
71728671|NCT02436668|142972000|SUPERIORITY|P-value is based on log-rank test stratified by the three randomization stratification factors \[KPS (70-80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\].|Hazard Ratio (HR)|1.109||||0.3225|TWO_SIDED|95.0|0.903|1.363|||Log Rank|||The treatment effect was tested with an stratified log rank test. Hazard ratio is estimated using Cox regression model stratified by the three randomization stratification factors \[KPS (70 80 vs. 90-100), liver metastasis (present vs. absent), and age (≤65 vs. \>65)\] and with treatment as the only covariate.||1.363|0.903|0.3225
71831107|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1004|TWO_SIDED|95.0|0.97|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16||1.47|0.97|0.1004
71888757|NCT03694392|143298616|OTHER||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.76|0.94|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 15.7% (6.0% to 24.5%)|||0.94|0.76|<0.05
71888758|NCT03694392|143298617|OTHER||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.6|1.34|||Regression, Cox||Relative vaccine effectiveness (95% CI) calculated as 1 minus the hazard ratio, expressed as a percentage: 10.3% (-33.9% to 39.9%)|||1.34|0.60|<0.05
71658652|NCT01462318|142832498|SUPERIORITY_OR_OTHER||ratio|1.012|||||TWO_SIDED|90.0|0.952|1.075|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.075|0.952|
71728672|NCT02436668|142972002|SUPERIORITY||Risk Ratio (RR)|0.695||||0.0058|TWO_SIDED|95.0|0.535|0.903|||Cochran-Mantel-Haenszel|||For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo + Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||0.903|0.535|0.0058
71728673|NCT02436668|142972004|SUPERIORITY||Risk Ratio (RR)|0.85||||0.0488|TWO_SIDED|95.0|0.722|1.0|||Cochran-Mantel-Haenszel||This 0.85 (0.722 to 1.0) with CI is referring to risk ratio not proportional/percentage of patients.|For rate ratio, numerator is Ibr+Gem/Abr arm and denominator is Pbo+Gem/Abr arm. P-value for rate ratio is based on Cochran-Mantel-Haenszel (CMH) test adjusted for the three randomization stratification factors. Two-sided 95% confidence interval for rate ratio is based on Mantel-Haenszel method.||1.0|0.722|0.0488
71728674|NCT02436668|142972005|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.0782|TWO_SIDED|95.0|0.975|1.642||P-value is from log-rank test stratified by the three randomization stratification factors.|Log Rank|||\[1\] Hazard ratio is based on a Cox proportional hazards model stratified by the three randomization stratification factors for time until definitive deterioration (TUDD1), a hazard ratio \< 1 favors Ibr + Gem/Abr. TUDD1 is defined as the time interval between randomization and the first occurrence of a decrease in score by \>= 10 points without any further improvement in score by \>= 10 points or any further available QoL data due to dropout after deterioration.||1.642|0.975|0.0782
71728675|NCT02436668|142972006|SUPERIORITY|||||||0.3343|||||||Chi-squared|||"For rate of VTEs, denominator is number of subjects in the Intent-to-Treat population and numerator is number of Intent-to-Treat subjects with at least one VTE observed any time on study. Confidence interval for rate of VTEs is based on Clopper-Pearson method.~\[1\] P value is based on Chi-square test."||||0.3343
71728676|NCT02210221|142972012|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in 6-month mortality||||<0.0001
71831108|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6258|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.25|0.87|0.6258
71831109|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.16||||0.1154|TWO_SIDED|95.0|0.96|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24||1.39|0.96|0.1154
71658653|NCT01462318|142832498|SUPERIORITY_OR_OTHER||ratio|1.058|||||TWO_SIDED|90.0|0.804|1.392|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.392|0.804|
71658654|NCT01462318|142832498|SUPERIORITY_OR_OTHER||ratio|1.116|||||TWO_SIDED|90.0|1.005|1.238|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (\>5% of Cmax).||1.238|1.005|
71888759|NCT05900115|143298625|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.77|TWO_SIDED||||||Regression, Linear|||||||0.77
71771334|NCT02043379|143042456|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.78||||||A p-value of \<0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative||||0.78
71728677|NCT02210221|142972012|OTHER||observed to expected ratio|0.7|||||TWO_SIDED|95.0|0.62|0.76|||||numerator: 6-month mortality observed denominator: 6-month mortality expected 95% CIs estimated according to a Poisson distribution|||0.76|0.62|
71728678|NCT02210221|142972013|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 mental component summary||||<0.0001
71728679|NCT02210221|142972013|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in SF-12v2 physical component summary||||<0.0001
71728680|NCT02210221|142972014|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No corrections for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum in Qolibri Overall Scale||||<0.0001
71728681|NCT02210221|142972015|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728682|NCT02210221|142972016|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728683|NCT02210221|142972017|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001||||||No correlations for multiple comparisons were done|ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728684|NCT02210221|142972018|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728685|NCT02210221|142972019|NON_INFERIORITY|non-inferiority margin = 0||||||0.169|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.169
71728686|NCT02210221|142972020|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||Fisher Exact|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728687|NCT02210221|142972021|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728688|NCT02210221|142972022|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728689|NCT02210221|142972023|NON_INFERIORITY|non-inferiority margin = 0||||||0.637|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.637
71728690|NCT02210221|142972024|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728691|NCT02210221|142972025|NON_INFERIORITY|non-inferiority margin = 0||||||0.48|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.480
71728692|NCT02210221|142972026|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728693|NCT02210221|142972027|NON_INFERIORITY|non-inferiority margin = 0||||||0.024|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.024
71728694|NCT02210221|142972028|NON_INFERIORITY|non-inferiority margin = 0||||||0.064|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||0.064
71728695|NCT02210221|142972029|NON_INFERIORITY|non-inferiority margin = 0|||||<|0.0001|||||||ANOVA|||null hypothesis: no difference between ER stratum, Admission stratum and ICU stratum||||<0.0001
71728696|NCT02230761|142972030|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.020
71728697|NCT02230761|142972031|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71728698|NCT02230761|142972032|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71728699|NCT00405964|142972037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Determined for site. P-value of \<.001 for treatment as well.|ANOVA|||||||<.001
71728700|NCT00405964|142972038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0||||Determined for site. Treatment p-value \<.001|ANOVA|||||||0.035
71728701|NCT00405964|142972039|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Same p-value for treatment and site.|ANOVA|||||||<.001
71728702|NCT02863523|142972049|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71728703|NCT02863523|142972050|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
71771335|NCT02043379|143042457|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.37||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour level||||0.37
71771336|NCT02043379|143042457|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level||||0.47
71771337|NCT02043379|143042457|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level||||0.47
71771338|NCT02043379|143042457|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level||||0.79
71728704|NCT02863523|142972051|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71728705|NCT00434759|142972064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value is not adjusted for multiple comparisons|ANOVA|We report the interaction effect.|The reported interaction effect is significant (p\< .05) in favour of standard therapy.|||||<0.05
71728706|NCT00434759|142972065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
71728707|NCT00434759|142972066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.05||95.0||||p-value is not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.|||||<0.05
71728708|NCT00434759|142972067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.43|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction is not significant.|||||<0.05
71728709|NCT00434759|142972068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.05||95.0||||priori threshold for statistical significance ist 0.05 p-value ist nor adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is significant (p \< .05) in favour of standard therapy|||||<0.05
71728710|NCT00997425|142972069|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door approach behavior||||||0.098
71728711|NCT00997425|142972069|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door pass through behavior||||||0.045
71888760|NCT05900115|143298626|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
71888761|NCT05900115|143298627|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.13|STANDARD_ERROR_OF_MEAN|0.12||0.28|TWO_SIDED||||||Regression, Linear|||||||0.28
71728712|NCT01300819|142972074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.147|TWO_SIDED|95.0|-8.43|1.26||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysing was performed with ANCOVA model, adjusted for several terms.||Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.||1.26|-8.43|0.147
71728713|NCT01300819|142972075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.002|TWO_SIDED|95.0|-4.27|-0.92||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.92|-4.27|0.002
71728714|NCT01300819|142972076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.024|TWO_SIDED|95.0|-5.21|-0.37||Two-sided p-values are presented.|ANCOVA|Testing was performed using an ANCOVA model, adjusted for several terms.||||-0.37|-5.21|0.024
71728715|NCT01300819|142972077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.773|TWO_SIDED|95.0|-0.67|0.5||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.50|-0.67|0.773
71728716|NCT01300819|142972078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.122|TWO_SIDED|95.0|-2.41|0.29||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.29|-2.41|0.122
71728717|NCT01300819|142972079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.047|TWO_SIDED|95.0|-3.59|-0.02||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.02|-3.59|0.047
71728718|NCT01300819|142972080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.601|TWO_SIDED|95.0|-0.22|0.37||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.37|-0.22|0.601
71728719|NCT01300819|142972081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.997|TWO_SIDED|95.0|-0.99|0.99||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.99|-0.99|0.997
71728720|NCT01300819|142972082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.584|TWO_SIDED|95.0|-0.87|0.49||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.49|-0.87|0.584
71728721|NCT01300819|142972083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.536|TWO_SIDED|95.0|-0.84|1.6||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||1.60|-0.84|0.536
71728722|NCT01300819|142972084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.889|TWO_SIDED|95.0|-0.81|0.94||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||0.94|-0.81|0.889
71728723|NCT01300819|142972085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.043|TWO_SIDED|95.0|-2.06|-0.03||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.||||-0.03|-2.06|0.043
71728724|NCT01319721|142972104|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71728725|NCT01319721|142972105|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71728726|NCT01319721|142972106|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.05
71728727|NCT01319721|142972107|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71728728|NCT01319721|142972108|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71728729|NCT00461305|142972109|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|13.4|||||TWO_SIDED|95.0|9.73|17.77|||Binominal parameter by exact method||No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.|Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.||17.77|9.73|
71728730|NCT00461305|142972109|SUPERIORITY_OR_OTHER||Incidence on one treatment arm|7.1||||||95.0|1.98|17.29|||Binominal parameter by exact method|||Exact 95% confident intervals were calculated using F-distribution by treatment group.||17.29|1.98|
71658655|NCT01462318|142832500|SUPERIORITY_OR_OTHER||ratio|0.878|||||TWO_SIDED|90.0|0.697|1.105|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.||1.105|0.697|
71728731|NCT00496197|142972146|SUPERIORITY_OR_OTHER||percentage of participants|83.7|||||TWO_SIDED|95.0|78.7|88.8|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||88.8|78.7|
71888762|NCT05900115|143298628|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
71888763|NCT05900115|143298629|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.01|TWO_SIDED||||||Regression, Linear|||||||0.01
71658656|NCT03167723|142832544|NON_INFERIORITY|15% Non-Inferiority||||||0.036|||||||Farrington-Manning|||||||0.036
71658657|NCT02992418|142832562|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMCs between groups (Group 1/ Group 2) was greater than (\>) 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|0.848|||||TWO_SIDED|95.0|0.721|0.997||||||Anti-PT||0.997|0.721|
71658658|NCT02992418|142832562|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.02|||||TWO_SIDED|95.0|0.892|1.18||||||Anti-FHA||1.18|0.892|
71658659|NCT02992418|142832562|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.836|1.46||||||Anti-PRN||1.46|0.836|
71658660|NCT02992418|142832562|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMCs between groups (Group 1/ Group 2) was \> 1/1.5 for each antigen. Overall non-inferiority was demonstrated if the 4 antigens achieved non-inferiority.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.827|1.33||||||Anti-FIM2+3||1.33|0.827|
71658661|NCT02992418|142832563|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|0.26|||||TWO_SIDED|95.0|-4.53|5.04||||||Anti-D||5.04|-4.53|
71658662|NCT02992418|142832563|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the percentage difference was \> -10% for all antigens.|Percentage difference|-0.66|||||TWO_SIDED|95.0|-2.87|1.37||||||Anti-T||1.37|-2.87|
71658663|NCT02992418|142832564|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.862|1.44||||||Serotype 1||1.44|0.862|
71658664|NCT02992418|142832564|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.47||||||Serotype 2||1.47|0.97|
71658665|NCT02992418|142832564|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.925|||||TWO_SIDED|95.0|0.739|1.16||||||Serotype 3||1.16|0.739|
71658666|NCT02992418|142832564|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (Group 1/Group 2) was \> 1/2 for each serotype. Overall non-inferiority was demonstrated if all 4 serotypes achieved non-inferiority.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.644|0.999||||||Serotype 4||0.999|0.644|
71658667|NCT01992523|142832596|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). Data were compared by means of the chi-2 test or Fisher exact test for categorical variables and unpaired t test or Mann-Whitney U-test for continuous variables, as appropriate. A P value \< .05 was considered statistically significant. All tests were two-sided.||||0.006
71658668|NCT04536935|142832604|SUPERIORITY|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the PHQ-9 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.8|-1.1|||Mixed Models Analysis|||||-1.1|-1.8|<.001
71658669|NCT04536935|142832605|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the GAD-7 and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.|Slope|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.6|-1.0|||Mixed Models Analysis|||||-1.0|-1.6|<.001
71658670|NCT04536935|142832606|OTHER|A series of mixed effects models using restricted maximum likelihood estimation were built to test linear time change on the DERS and to test for condition differences at follow-up and change slope. Models were built in an outwardly nested fashion, such that an initial null model was computed, followed by models that added a random intercept, random time component, condition assignment, and condition x time interaction effects.||||||0.73|||||||Mixed Models Analysis|||||||.73
71658671|NCT04536935|142832607|OTHER|||||||0.25|||||||Mixed Models Analysis|||||||.25
71658672|NCT04536935|142832608|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.22
71658673|NCT04536935|142832609|SUPERIORITY|||||||0.48|||||||ANOVA|||||||.48
71658674|NCT04536935|142832610|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<.0001
71661149|NCT00191113|142835873|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9|||<|0.001||95.0|5.7|8.1|||ANCOVA|||||8.1|5.7|<0.001
71888764|NCT05900115|143298630|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.18|TWO_SIDED||||||Regression, Linear|||||||0.18
71728732|NCT00496197|142972147|SUPERIORITY_OR_OTHER||percentage of participants|93.0|||||TWO_SIDED|95.0|89.4|96.7|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOT||96.7|89.4|
71728733|NCT00496197|142972148|SUPERIORITY_OR_OTHER||percentage of participants|95.3|||||TWO_SIDED|95.0|92.3|98.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOT||98.3|92.3|
71728734|NCT00496197|142972149|SUPERIORITY_OR_OTHER||percentage of participants|88.5|||||TWO_SIDED|95.0|84.4|92.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||92.6|84.4|
71728735|NCT00496197|142972150|SUPERIORITY_OR_OTHER||percentage of participants|93.1|||||TWO_SIDED|95.0|89.8|96.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOIV||96.4|89.8|
71728736|NCT00496197|142972151|SUPERIORITY_OR_OTHER||percentage of participants|92.6|||||TWO_SIDED|95.0|89.3|95.9|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOIV||95.9|89.3|
71728737|NCT00496197|142972152|SUPERIORITY_OR_OTHER||percentage of participants|76.3|||||TWO_SIDED|95.0|70.3|82.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||82.3|70.3|
71728738|NCT00496197|142972153|SUPERIORITY_OR_OTHER||percentage of participants|94.8|||||TWO_SIDED|95.0|91.5|98.1|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 2 Follow-up||98.1|91.5|
71728739|NCT00496197|142972154|SUPERIORITY_OR_OTHER||percentage of participants|95.4|||||TWO_SIDED|95.0|92.2|98.5|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 2 Follow-up||98.5|92.2|
71728740|NCT00496197|142972155|SUPERIORITY_OR_OTHER||percentage of participants|70.1|||||TWO_SIDED|95.0|63.5|76.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.6|63.5|
71728741|NCT00496197|142972156|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 6 Follow-up (EOS)||97.4|89.7|
71728742|NCT00496197|142972157|SUPERIORITY_OR_OTHER||percentage of participants|93.6|||||TWO_SIDED|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 6 Follow-up (EOS)||97.4|89.7|
71888765|NCT05900115|143298631|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
71728743|NCT00496197|142972158|SUPERIORITY_OR_OTHER||percentage of participants|82.5|||||TWO_SIDED|95.0|75.7|89.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT||89.3|75.7|
71728744|NCT00496197|142972159|SUPERIORITY_OR_OTHER||percentage of participants|85.6|||||TWO_SIDED|95.0|79.8|91.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV||91.4|79.8|
71728745|NCT00496197|142972160|SUPERIORITY_OR_OTHER||percentage of participants|76.7|||||TWO_SIDED|95.0|69.0|84.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up||84.4|69.0|
71728746|NCT00496197|142972161|SUPERIORITY_OR_OTHER||percentage of participants|67.6|||||TWO_SIDED|95.0|58.9|76.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)||76.3|58.9|
71728747|NCT01344538|142972170|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71728748|NCT00929773|142972243|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71728749|NCT00929773|142972244|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
71728750|NCT00929773|142972245|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71728751|NCT00929773|142972246|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71728752|NCT00929773|142972247|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71728753|NCT00929773|142972248|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71728754|NCT02583230|142972270|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in PHQ-9 total scores over the eight-week study period.||||||.0005
71728755|NCT02583230|142972271|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in QIDS total scores over the eight-week study period.||||||.0008
71728756|NCT02685748|142972325|OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.444||0.863|TWO_SIDED|95.0|-0.969|0.815|||t-test, 2 sided|||||0.815|-0.969|0.863
71728757|NCT02685748|142972326|OTHER|T test for independent samples|Mean Difference (Final Values)|3.616|STANDARD_ERROR_OF_MEAN|2.364||0.133|TWO_SIDED|95.0|-1.147|8.379|||t-test, 2 sided|||||8.379|-1.147|0.133
71728758|NCT02685748|142972327|OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.43||1.607|TWO_SIDED|95.0|-1.1553|0.172|||t-test, 2 sided|||||0.172|-1.1553|1.607
71728759|NCT02685748|142972328|OTHER||Mean Difference (Final Values)|-1.282|STANDARD_ERROR_OF_MEAN|1.754||0.468|TWO_SIDED|95.0|-4.807|2.241|||t-test, 2 sided|||||2.241|-4.807|0.468
71728760|NCT02685748|142972329|OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.406||0.899|TWO_SIDED|95.0|-0.869|0.765|||t-test, 2 sided|||||0.765|-0.869|0.899
71728761|NCT02685748|142972330|OTHER||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|6.797||0.305|TWO_SIDED|95.0|-6.602|20.703|||t-test, 2 sided|||||20.703|-6.602|0.305
71728762|NCT02685748|142972331|OTHER||Mean Difference (Final Values)|160.298|STANDARD_ERROR_OF_MEAN|159.525||0.32|TWO_SIDED|95.0|-160.118|480.714|||t-test, 2 sided|||||480.714|-160.118|0.320
71728763|NCT02685748|142972332|OTHER||Mean Difference (Final Values)|-1.495|STANDARD_ERROR_OF_MEAN|3.558||0.676|TWO_SIDED|95.0|-8.642|5.651|||t-test, 2 sided|||||5.651|-8.642|0.676
71728764|NCT00328653|142972333|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H Chi-square|1.2187||||0.2699|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2699
71728765|NCT00328653|142972333|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H Chi-square|1.2359||||0.2719|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2719
71728766|NCT00328653|142972336|SUPERIORITY|Comparisons of NOVA22007 0.05% to vehicle|M-H-Chi-square|4.2925||||0.0386|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0386
71728767|NCT00328653|142972336|SUPERIORITY|Comparisons of NOVA22007 0.1% to vehicle|M-H-Chi-square|5.3007||||0.0208|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0208
71728768|NCT03832114|142972377|OTHER|Log Ratio to Baseline|Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||||0.65|0.46|0.0003
71728769|NCT03832114|142972378|OTHER||Median Difference (Final Values)|-2.5||||0.0313|TWO_SIDED|80.0|-3.75|-0.75|||Wilcoxon (Mann-Whitney)|||||-0.75|-3.75|0.0313
71728770|NCT03832114|142972379|OTHER||Mean Difference (Final Values)|0.55||||0.0003|TWO_SIDED|80.0|0.46|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.65|0.46|0.0003
71661150|NCT00191113|142835874|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71661151|NCT00191113|142835875|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
71728771|NCT03832114|142972379|OTHER||Mean Difference (Final Values)|0.79||||0.4766|TWO_SIDED|80.0|0.49|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.28|0.49|0.4766
71728772|NCT03832114|142972379|OTHER||Mean Difference (Final Values)|0.59||||0.0002|TWO_SIDED|80.0|0.51|0.69|||Mixed Model of Repeated Measures (MMRM)|||Overall- Day 84||0.69|0.51|0.0002
71728773|NCT03832114|142972380|OTHER||Mean Difference (Final Values)|0.57||||0.0011|TWO_SIDED|80.0|0.47|0.68|||Mixed Model Repeated Measures (MMRM|||Day 84||0.68|0.47|0.0011
71728774|NCT03832114|142972380|OTHER||Mean Difference (Final Values)|1.0||||0.9998|TWO_SIDED|80.0|0.75|1.33|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.33|0.75|0.9998
71728775|NCT03832114|142972380|OTHER||Mean Difference (Final Values)|0.66||||0.0016|TWO_SIDED|80.0|0.56|0.77|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.77|0.56|0.0016
71728776|NCT03832114|142972381|OTHER||Mean Difference (Final Values)|0.55|||<|0.0001|TWO_SIDED|80.0|0.47|0.64|||Mixed Model Repeated Measures (MRM)|||Day 84||0.64|0.47|<0.0001
71728777|NCT03832114|142972381|OTHER||Mean Difference (Final Values)|0.61||||0.3707|TWO_SIDED|80.0|0.3|1.27|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.27|0.30|0.3707
71728778|NCT03832114|142972381|OTHER||Mean Difference (Final Values)|0.6||||0.0002|TWO_SIDED|80.0|0.51|0.71|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||0.71|0.51|0.0002
71661152|NCT00191113|142835876|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Fisher Exact|||||||0.073
71728779|NCT03832114|142972382|OTHER||Mean Difference (Final Values)|0.57||||0.0018|TWO_SIDED|80.0|0.47|0.7|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.70|0.47|0.0018
71728780|NCT03832114|142972382|OTHER||Mean Difference (Final Values)|0.81||||0.1632|TWO_SIDED|80.0|0.67|0.98|||Mixed Model Repeated Measures (MMRM)|||Day 84||0.98|0.67|0.1632
71728781|NCT03832114|142972382|OTHER||Mean Difference (Final Values)|0.67||||0.004|TWO_SIDED|80.0|0.57|0.79|||Mixed Model Repeated Measure (MMRM)|||Overall- Day 84||0.79|0.57|0.0040
71728782|NCT03832114|142972383|OTHER||Mean Difference (Final Values)|2.59||||0.1795|TWO_SIDED|80.0|0.12|5.06|||Mixed Model of Repeated Measures (MMRM)|||Day 84||5.06|0.12|0.1795
71728783|NCT03832114|142972383|OTHER||Mean Difference (Final Values)|-0.61||||0.7763|TWO_SIDED|0.7763|-3.36|2.15|||Mixed Model Repeated Measures (MMRM)|||Day 84||2.15|-3.36|0.7763
71728784|NCT03832114|142972383|OTHER||Mean Difference (Final Values)|1.32||||0.3754|TWO_SIDED|80.0|-0.59|3.22|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||3.22|-0.59|0.3754
71728785|NCT03832114|142972384|OTHER||Mean Difference (Final Values)|-5.04||||0.1364|TWO_SIDED|80.0|-9.36|-0.72|||Mixed Model Repeated Measuers (MMRM)|||Day 84||-0.72|-9.36|0.1364
71728786|NCT03832114|142972384|OTHER||Mean Difference (Final Values)|7.17||||0.3038|TWO_SIDED|80.0|-1.79|16.13|||Mixed Model Repeated Measures (MMRM)|||Day 84||16.13|-1.79|0.3038
71728787|NCT03832114|142972384|OTHER||Mean Difference (Final Values)|-0.77||||0.8352|TWO_SIDED|80.0|-5.56|4.01|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||4.01|-5.56|0.8352
71728788|NCT03832114|142972385|OTHER||Mean Difference (Final Values)|1.07||||0.2752|TWO_SIDED|80.0|0.99|1.17|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.17|0.99|0.2752
71728789|NCT03832114|142972385|OTHER||Mean Difference (Final Values)|1.2||||0.476|TWO_SIDED|80.0|0.83|1.72|||Mixed Model Repeated Measures (MMRM)|||Day 84||1.72|0.83|0.476
71728790|NCT03832114|142972385|OTHER||Mean Difference (Final Values)|1.1||||0.1963|TWO_SIDED|80.0|1.0|1.2|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 84||1.20|1.00|0.1963
71728791|NCT03832114|142972387|OTHER||Mean Difference (Final Values)|0.56|||<|0.0001|TWO_SIDED|80.0|0.48|0.65|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.65|0.48|<0.0001
71728792|NCT03832114|142972387|OTHER||Mean Difference (Final Values)|0.99||||0.9544|TWO_SIDED|80.0|0.76|1.28|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.28|0.76|0.9544
71728793|NCT03832114|142972387|OTHER||Mean Difference (Final Values)|0.64|||<|0.0001|TWO_SIDED|80.0|0.56|0.72|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.72|0.56|<.0001
71728794|NCT03832114|142972388|OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|80.0|0.5|0.69|||Mixed Model Repeated Measures (MMRM)|||Day 64||0.69|0.50|<.0001
71728795|NCT03832114|142972388|OTHER||Median Difference (Final Values)|0.87||||0.6209|TWO_SIDED|80.0|0.6|1.26|||Mixed Model Repeated Measures (MMRM)|||Day 64||1.26|0.60|0.6209
71728796|NCT03832114|142972388|OTHER||Mean Difference (Final Values)|0.63||||0.0002|TWO_SIDED|80.0|0.54|0.73|||Mixed Model Repeated Measures (MMRM)|||Overall- Day 64||0.73|0.54|0.0002
71728797|NCT03054350|142972396|SUPERIORITY||Least squares mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.314||0.0004|TWO_SIDED|95.0|0.56|1.82|||ANCOVA|The analysis of covariance (ANCOVA) model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.82|0.56|0.0004
71831110|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8018|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.22|0.86|0.8018
71831111|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5697|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32||1.26|0.88|0.5697
71888766|NCT05900115|143298632|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED||||||Regression, Linear|||||||0.56
71728798|NCT03054350|142972396|SUPERIORITY||Least squares mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.315|<|0.0001|TWO_SIDED|95.0|0.93|2.19|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.19|0.93|<0.0001
71728799|NCT03054350|142972396|SUPERIORITY||Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|1.23|2.54|||ANCOVA|The ANCOVA model includes treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.54|1.23|<0.0001
71728800|NCT03054350|142972402|SUPERIORITY||Least squares mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.122||0.0232|TWO_SIDED|95.0|0.04|0.54|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups;1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.54|0.04|0.0232
71728801|NCT03054350|142972402|SUPERIORITY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.121||0.0033|TWO_SIDED|95.0|0.13|0.62|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.62|0.13|0.0033
71728802|NCT03054350|142972402|SUPERIORITY||Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.12||0.0002|TWO_SIDED|95.0|0.26|0.74|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.74|0.26|0.0002
71728803|NCT03054350|142972402|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.3289|TWO_SIDED|94.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.3289
71728804|NCT03054350|142972402|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.007||0.2607|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.01|0.2607
71728805|NCT03054350|142972402|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.0252|TWO_SIDED|95.0|0.0|0.03|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.03|0.00|0.0252
71728806|NCT03054350|142972404|SUPERIORITY||Least squares mean difference|3.31|STANDARD_ERROR_OF_MEAN|1.303||0.0154|TWO_SIDED|95.0|0.67|5.94|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.94|0.67|0.0154
71728807|NCT03054350|142972404|SUPERIORITY||Least squares mean difference|4.61|STANDARD_ERROR_OF_MEAN|1.261||0.0008|TWO_SIDED|95.0|2.06|7.16|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.16|2.06|0.0008
71728808|NCT03054350|142972404|SUPERIORITY||Least squares mean difference|5.93|STANDARD_ERROR_OF_MEAN|1.296|<|0.0001|TWO_SIDED|95.0|3.31|8.56|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||8.56|3.31|<0.0001
71728809|NCT03054350|142972404|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.273||0.3572|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.81|-0.30|0.3572
71728810|NCT03054350|142972404|SUPERIORITY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.252||0.4758|TWO_SIDED|95.0|-0.33|0.69|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.69|-0.33|0.4758
71728811|NCT03054350|142972404|SUPERIORITY||Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.254||0.2048|TWO_SIDED|95.0|-0.19|0.84|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.84|-0.19|0.2048
71728812|NCT03054350|142972406|SUPERIORITY|||||||0.9373|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9373
71728813|NCT03054350|142972406|SUPERIORITY|||||||0.6623|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.6623
71728814|NCT03054350|142972406|SUPERIORITY|||||||0.9374|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.9374
71728815|NCT03054350|142972406|SUPERIORITY|||||||0.2085|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.2085
71728816|NCT03054350|142972406|SUPERIORITY|||||||0.0016|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0016
71728817|NCT03054350|142972406|SUPERIORITY|||||||0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0001
71728818|NCT03054350|142972408|SUPERIORITY|||||||0.2708|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.2708
71728819|NCT03054350|142972408|SUPERIORITY|||||||0.0966|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0966
71728820|NCT03054350|142972408|SUPERIORITY|||||||0.0424|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.0424
71728821|NCT03054350|142972410|SUPERIORITY|||||||0.0207|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0207
71728822|NCT03054350|142972410|SUPERIORITY|||||||0.0022|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0022
71728823|NCT03054350|142972410|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
71728824|NCT03054350|142972410|SUPERIORITY|||||||0.0062|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0062
71728825|NCT03054350|142972410|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0002
71728826|NCT03054350|142972410|SUPERIORITY||||||<|0.0001||||||test of treatment group difference based on ANCOVA model|ANCOVA|||Hepcidin||||<0.0001
71728827|NCT01643850|142972455|SUPERIORITY||Mean Difference (Net)|0.98||||0.915|TWO_SIDED|95.0|0.71|1.36|||ANCOVA|||||1.36|0.71|0.915
71728828|NCT01643850|142972455|SUPERIORITY||Median Difference (Net)|0.78||||0.117|TWO_SIDED|95.0|0.57|1.07|||ANCOVA|||||1.07|0.57|0.117
71728829|NCT01643850|142972455|SUPERIORITY||Mean Difference (Net)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91|||ANCOVA|||||0.91|0.52|0.010
71728830|NCT02240368|142972516|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
71728831|NCT02240368|142972517|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||bootstrap|||||||<0.01
71728832|NCT02240368|142972518|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71728833|NCT02240368|142972519|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71888767|NCT05900115|143298633|EQUIVALENCE|To examine intervention effects on primary dichotomous outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Odds Ratio (OR)|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.85|TWO_SIDED|95.0|0.38|3.2|||Regression, Logistic|||||3.20|.38|0.85
71728834|NCT04612842|142972544|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71728835|NCT02419131|142972555|SUPERIORITY|Superiority of the experimental arms (CBTH and CPT) compared to usual care (TAU)|Aggregated contrast CBTH to TAU|-3.4|||<|0.001|TWO_SIDED|95.0|-5.4|-1.4||p-value represents an aggregate of post-treatment outcomes (i.e., post-treatment, 3-month, and 6-month outcomes entered simultaneously into the GLMM to represent a single metric of all post-treatment assessment intervals into one estimate).|Mixed Models Analysis|Outcome observations at posttreatment, 3-month and 6-month follow-ups were entered simultaneously into the mixed model to provide a single inference.|Contrast of aggregated post-treatment outcomes of HIT-6 total score for CBTH compared to TAU|Sample size based on 2-tailed specified joint superiority testing of 2 primary outcomes at α = .025 and power of 0.80 to detect an effect size (d) of 0.52 for both primary outcomes (representing a clinically significant change of 2.8 points on the HIT-6). The primary analysis set was intention to treat (ITT). multiple imputation accounted for missing data in ITT. Missing outcome scores at posttreatment, 3-month, and 6-month follow-ups were multiply imputed (m = 100) using multilevel models.||-1.4|-5.4|<0.001
71728836|NCT02419131|142972555|SUPERIORITY|See previous section for analysis|Aggregated contrast CPT to TAU|-1.4||||0.21|TWO_SIDED|95.0|-3.7|0.8||For comparison of post-treatment HIT-6 total score between CPT and TAU|Mixed Models Analysis|See above for details.|See above.|See previous section for power||0.8|-3.7|0.21
71728837|NCT02419131|142972556|SUPERIORITY|Key parameters and details the same as HIT-6 described above.|Aggregated contrast CBTH to TAU|-6.5||||0.04|TWO_SIDED|95.0|-12.7|-0.3||Contrast of aggregate post-treatment outcomes between CBTH and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CBTH and TAU||Same sample size calculation as HIT-6 analyses, powered to detect a difference of 8.2 points on the PCL-5 total score.||-0.3|-12.7|0.04
71728838|NCT02419131|142972556|SUPERIORITY|Contrast of aggregate post-treatment outcomes between CPT and TAU|Aggregated contrast CPT to TAU|-8.9||||0.01|TWO_SIDED|95.0|-15.9|-1.9||Contrast of aggregate post-treatment outcomes between CPT and TAU|Mixed Models Analysis|Contrast of aggregate post-treatment outcomes between CPT and TAU||See above.||-1.9|-15.9|0.01
71728839|NCT00089986|142972586|SUPERIORITY_OR_OTHER||Rate difference|1.1||||0.329|ONE_SIDED|90.0|-2.1||||Chi-squared||||||-2.1|0.329
71728840|NCT00089986|142972586|SUPERIORITY_OR_OTHER||Rate Difference|-4.4||||0.879|ONE_SIDED|90.0|-9.4||||Chi-squared||||||-9.4|0.879
71728841|NCT03995680|142972600|SUPERIORITY||Difference in Egg Reduction Rate (%)|2.3|||||TWO_SIDED|95.0|-7.8|12.6|||Regression, Logistic|Adjusted for age, sex, weight and baseline hookworm infection intensity (light or moderate/heavy)||The 95% confidence intervals (CIs) for ERRs and the difference between ERRs were estimated via bootstrap resampling. Superiority was claimed if the 95% confidence interval of the difference in ERRs did not include unity. Logistic regression models were used to assess efficacy in terms of CRs. In a subsequent analysis an adjusted logistic regression (adjustment for age, sex, weight and baseline infection intensity) was performed.||12.6|-7.8|
71728842|NCT02437305|142972612|SUPERIORITY_OR_OTHER|||||||0.048||||||P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||0.048
71728843|NCT02437305|142972613|SUPERIORITY_OR_OTHER||||||>|0.5||||||P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.|McNemar|||||||>0.50
71728844|NCT01187004|142972632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Logistic|significant level for inclusion at the univariate analysis was p\<0.05.||Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.||||<0.05
71728845|NCT01187004|142972633|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.199|||<|0.001|TWO_SIDED|95.0|1.129|1.272|||Wilcoxon (Mann-Whitney)|||||1.272|1.129|<0.001
71728846|NCT01071200|142972644|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon two sample test|||Change at hCG day : Wilcoxon two sample test was used to calculate p-value.||||0.07
71728847|NCT03730961|142972655|SUPERIORITY|Drug - placebo|Mean Difference (Net)|-448.0||||0.0021|TWO_SIDED|95.0|-714.0|-183.0|||t-test, 2 sided|||||-183|-714|0.0021
71728848|NCT03730961|142972655|SUPERIORITY|Percent change Drug - placebo|Mean Difference (Net)|-22.1||||0.0222|TWO_SIDED|95.0|-40.7|-3.51|||t-test, 2 sided|||||-3.51|-40.7|0.0222
71728849|NCT03730961|142972656|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-4.25||||0.0163|TWO_SIDED|95.0|-7.63|-0.876|||t-test, 2 sided|||||-0.876|-7.63|0.0163
71728850|NCT03730961|142972656|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|-15.0||||0.2018|TWO_SIDED|95.0|-38.8|8.77|||t-test, 2 sided|||||8.77|-38.8|0.2018
71728851|NCT03730961|142972656|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-3.61||||0.0526|TWO_SIDED|95.0|-7.27|0.0446|||t-test, 2 sided|||||0.0446|-7.27|0.0526
71728852|NCT03730961|142972656|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|-14.9||||0.2076|TWO_SIDED|95.0|-38.8|9.0|||t-test, 2 sided|||||9|-38.8|0.2076
71728853|NCT03730961|142972657|SUPERIORITY|Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|0.431||||0.1621|TWO_SIDED|95.0|-0.189|1.05|||t-test, 2 sided|||||1.05|-0.189|0.1621
71728854|NCT03730961|142972657|SUPERIORITY|Percent change Drug - placebo, 0-4 hours after furosemide|Mean Difference (Net)|32.0||||0.0338|TWO_SIDED|95.0|2.72|61.3|||t-test, 2 sided|||||61.3|2.72|0.0338
71728855|NCT03730961|142972657|SUPERIORITY|Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|0.766||||0.06|TWO_SIDED|95.0|-0.0353|1.57|||t-test, 2 sided|||||1.57|-0.0353|0.0600
71728856|NCT03730961|142972657|SUPERIORITY|Percent change Drug - placebo, 0-8 hours after start of infusion|Mean Difference (Net)|33.5||||0.028|TWO_SIDED|95.0|4.02|63.0|||t-test, 2 sided|||||63|4.02|0.0280
71728857|NCT03730961|142972660|SUPERIORITY||Difference between drug and placebo|-4.0|STANDARD_DEVIATION|4.74||||||||||||||||
71728858|NCT01527513|142972674|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|Mean Difference (Final Values)|33.2001||||0.7|TWO_SIDED|95.0|-137.593|203.993|||95% CI lower bound vs non-inf margin|||||203.993|-137.593|0.700
71728859|NCT01527513|142972675|NON_INFERIORITY_OR_EQUIVALENCE|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|95% CI lower bound vs non-inf margin|33.2001|||<|0.7|TWO_SIDED|95.0|-137.593|203.993|||ANCOVA||The predefined non-inferiority margin was -121ms.|||203.993|-137.593|<0.700
71728860|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-2.12||||0.956|TWO_SIDED|95.0|-79.67|75.42|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 1||75.42|-79.67|0.956
71728861|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.995|TWO_SIDED|95.0|-105.41|106.07|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 14||106.07|-105.41|0.995
71728862|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-59.35||||0.366|TWO_SIDED|95.0|-191.15|72.45|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 5 mg and placebo on Day 28||72.45|-191.15|0.366
71728863|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-100.02||||0.016|TWO_SIDED|95.0|-179.96|-20.08|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 1||-20.08|-179.96|0.016
71728864|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-137.85||||0.014|TWO_SIDED|95.0|-245.28|-30.43|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 14||-30.43|-245.28|0.014
71728865|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-229.04||||0.001|TWO_SIDED|95.0|-362.17|-95.91|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 10 mg and placebo on Day 28||-95.91|-362.17|0.001
71728866|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-89.98||||0.025|TWO_SIDED|95.0|-167.62|-12.33|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 1||-12.33|-167.62|0.025
71728867|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-222.02|||<|0.001|TWO_SIDED|95.0|-326.54|-117.51|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 14||-117.51|-326.54|<0.001
71728868|NCT04465877|142972680|SUPERIORITY||Mean Difference (Final Values)|-248.82|||<|0.001|TWO_SIDED|95.0|-379.35|-118.28|||Mixed Models Analysis|||Difference between change from baseline in PPG (AUEC0-4) value for JTT-662 20 mg and placebo on Day 28||-118.28|-379.35|<0.001
71728869|NCT04962230|142972687|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|specify in comments|56.82||||0.05|TWO_SIDED|90.0|47.04|68.62|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||68.62|47.04|0.05
71728870|NCT04962230|142972688|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.5||||0.05|TWO_SIDED|90.0|33.77|58.65|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.65|33.77|0.05
71728871|NCT04962230|142972689|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|25.59||||0.05|TWO_SIDED|90.0|18.76|34.91|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||34.91|18.76|0.05
71728872|NCT04962230|142972690|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|16.57||||0.05|TWO_SIDED|90.0|13.32|20.6|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||20.60|13.32|0.05
71728873|NCT04962230|142972696|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|44.59||||0.05|TWO_SIDED|90.0|33.99|58.5|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||58.50|33.99|0.05
71728874|NCT04962230|142972701|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir coadministered with carbamazepine was the Test treatment.|Specified in comments|12.92||||0.05|TWO_SIDED|90.0|9.28|17.99|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of adjusted geometric means 2.90% CI for the ratios"|||17.99|9.28|0.05
71728875|NCT04346108|142972738|SUPERIORITY||Poisson Estimate|1.65|||||TWO_SIDED|95.0|0.73|3.15||||||||3.15|0.73|
71728876|NCT04346108|142972738|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71728877|NCT04346108|142972738|SUPERIORITY||Poisson Estimate|2.48|||||TWO_SIDED|95.0|1.34|4.13||||||||4.13|1.34|
71728878|NCT04346108|142972739|SUPERIORITY||Poisson Estimate|2.6|||||TWO_SIDED|95.0|1.02|5.3||||||||5.30|1.02|
71728879|NCT04346108|142972739|SUPERIORITY||Poisson Estimate|9.82|||||TWO_SIDED|95.0|2.82|23.82||||||||23.82|2.82|
71728880|NCT04346108|142972739|SUPERIORITY||Poisson Estimate|2.87|||||TWO_SIDED|95.0|1.37|5.18||||||||5.18|1.37|
71728881|NCT04346108|142972740|SUPERIORITY||Poisson Estimate|4.01||||||95.0|1.46|8.54||||||||8.54|1.46|
71728882|NCT04346108|142972740|SUPERIORITY||Poisson Estimate|3.07|||||TWO_SIDED|95.0|0.37|10.74||||||||10.74|0.37|
71728883|NCT04346108|142972740|SUPERIORITY||Poisson Estimate|5.87|||||TWO_SIDED|95.0|2.32|11.93||||||||11.93|2.32|
71728884|NCT04346108|142972741|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.0|0.0|
71728885|NCT04346108|142972741|SUPERIORITY||Poisson Estimate|0.13|||||TWO_SIDED|95.0|0.03|0.35||||||||0.35|0.03|
71728886|NCT04346108|142972741|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71728887|NCT04346108|142972742|SUPERIORITY||Poisson Estimate|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71728888|NCT04346108|142972742|SUPERIORITY||Poisson Estimate|1.04|||||TWO_SIDED|95.0|0.25|2.76||||||||2.76|0.25|
71728889|NCT04346108|142972743|SUPERIORITY||Poisson Estimate|1.18|||||TWO_SIDED|95.0|0.38|2.68||||||||2.68|0.38|
71728890|NCT04346108|142972743|SUPERIORITY||Poisson Estimate|2.35|||||TWO_SIDED|95.0|0.91|4.82||||||||4.82|0.91|
71728891|NCT04346108|142972743|SUPERIORITY||Poisson Estimate|0.61|||||TWO_SIDED|95.0|0.07|2.15||||||||2.15|0.07|
71728892|NCT02159118|142972755|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71728893|NCT02159118|142972756|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71728894|NCT02159118|142972757|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71728895|NCT02159118|142972758|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71728896|NCT02159118|142972759|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71728897|NCT02159118|142972760|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
71728898|NCT02159118|142972761|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71728899|NCT02159118|142972762|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71728900|NCT02159118|142972763|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71728901|NCT00386477|142972764|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.11||95.0|0.26|1.11|||Chi-squared, Corrected|||||1.11|0.26|0.11
71728902|NCT02446418|142972765|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.8||||0.033|TWO_SIDED|95.0|0.1|1.5|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.|1.5|0.1|0.033
71728903|NCT02446418|142972766|NON_INFERIORITY|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.4||||0.224|TWO_SIDED|95.0|-0.3|1.1|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.|1.1|-0.3|0.224
71728904|NCT02446418|142972767|SUPERIORITY||Adjusted Odds Ratio|1.11||||0.82|TWO_SIDED|95.0|0.47|2.62|||Regression, Logistic|||Week 12|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|2.62|0.47|0.820
71728905|NCT02446418|142972767|SUPERIORITY||Adjusted Odds Ratio|1.41||||0.566|TWO_SIDED|95.0|0.43|4.6|||Regression, Logistic|||Week 24|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.|4.60|0.43|0.566
71728906|NCT02014480|142972775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.065|0.151||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.151|0.065|<0.001
71728907|NCT02014480|142972775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|||<|0.001|TWO_SIDED|95.0|0.064|0.149||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.149|0.064|<0.001
71728908|NCT02014480|142972775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|||<|0.001|TWO_SIDED|95.0|0.086|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.086|<0.001
71771339|NCT02043379|143042457|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of \<0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level||||0.04
71728909|NCT02014480|142972775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.04|0.125||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.125|0.040|<0.001
71728910|NCT02014480|142972775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||<|0.001|TWO_SIDED|95.0|0.036|0.12||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.120|0.036|<0.001
71728911|NCT02014480|142972775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.008|TWO_SIDED|95.0|0.015|0.099||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.099|0.015|0.008
71728912|NCT01865812|142972779|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.51|-0.24||||||||-0.24|-0.51|
71728913|NCT01865812|142972780|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||||-0.25|-0.63|
71728914|NCT01865812|142972781|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-1.58|1.46||||||||1.46|-1.58|
71728915|NCT01865812|142972832|SUPERIORITY_OR_OTHER_LEGACY|||||||0.852|||||||ANCOVA|||||||0.852
71728916|NCT01865812|142972833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549|||||||ANCOVA|||||||0.549
71728917|NCT01865812|142972834|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912|||||||ANCOVA|||||||0.912
71728918|NCT01414205|142972836|SUPERIORITY_OR_OTHER||Difference (Hauck-Anderson)|17.89||||0.0779|TWO_SIDED|95.0|-4.95|40.72|||Cochran-Mantel-Haenszel|P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.||||40.72|-4.95|0.0779
71728919|NCT01854632|142972851|SUPERIORITY_OR_OTHER|||||||0.996|TWO_SIDED||||||Log Rank|||||||0.996
71728920|NCT01819129|142972899|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.15|0.1|||||The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).|Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.10|-0.15|
71728921|NCT02836873|142972903|SUPERIORITY||Difference of LS Means|-0.28||||0.0026|TWO_SIDED|95.0|-0.46|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||This is a mixed-effects repeated measures analysis including region, screening anti-diabetic treatment regimen, baseline eGFR, treatment, visit, treatment-by-visit interaction and baseline HbA1c as a fixed effect covariate. Data from Weeks 6, 12, and 24 are used in the model.||-0.10|-0.46|0.0026
71728922|NCT02836873|142972904|SUPERIORITY||Difference of LS Means|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.03|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-1.03|-2.50|< 0.0001
71728923|NCT02836873|142972905|SUPERIORITY||Difference of LS Means|-2.63||||0.2035|TWO_SIDED|95.0|-6.7|1.44|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||1.44|-6.70|0.2035
71728924|NCT02836873|142972906|SUPERIORITY||Difference of LS Means|-0.2||||0.1156|TWO_SIDED|95.0|-0.44|0.05|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||0.05|-0.44|0.1156
71728925|NCT02836873|142972907|SUPERIORITY||Difference of LS Means|-0.37||||0.0078|TWO_SIDED|95.0|-0.65|-0.1|||Mixed-effects repeated measures|Region, screening anti-diabetic treatment, baseline eGFR, treatment, visit, treatment-by-visit and baseline HbA1c value as fixed effect covariates.||||-0.10|-0.65|0.0078
71728926|NCT02214225|142972920|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.92|||||TWO_SIDED|95.0|0.87|0.98||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.87|
71728927|NCT02214225|142972920|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.93|||||TWO_SIDED|95.0|0.88|0.98||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.88|
71728928|NCT02214225|142972920|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.87|||||TWO_SIDED|95.0|0.81|0.93||||||For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.93|0.81|
71728929|NCT02214225|142972920|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.94|||||TWO_SIDED|95.0|0.86|1.01||||||For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.01|0.86|
71728930|NCT02214225|142972921|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-1.1|||||TWO_SIDED|95.0|-4.4|2.2||||||||2.2|-4.4|
71728931|NCT02214225|142972921|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-1.7|||||TWO_SIDED|95.0|-5.0|1.6||||||||1.6|-5.0|
71728932|NCT02214225|142972921|NON_INFERIORITY_OR_EQUIVALENCE|For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-3.2|||||TWO_SIDED|95.0|-7.0|0.5||||||||0.5|-7.0|
71728933|NCT02214225|142972921|NON_INFERIORITY_OR_EQUIVALENCE|For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-1.6|||||TWO_SIDED|95.0|-5.6|2.4||||||||2.4|-5.6|
71728934|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.85|
71728935|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.91|||||TWO_SIDED|95.0|0.83|0.99||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.99|0.83|
71728936|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.86|||||TWO_SIDED|95.0|0.76|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.76|
71728937|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.86|||||TWO_SIDED|95.0|0.76|0.98||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.98|0.76|
71728938|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.95|||||TWO_SIDED|95.0|0.88|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.88|
71771340|NCT02043379|143042458|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.43||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.43
71771341|NCT02043379|143042458|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.68||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||max||||0.68
71771342|NCT02043379|143042459|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.87||||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative||||0.87
71661153|NCT00191113|142835877|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||Comparison of proportion of patients with any category of hearing loss between As-Treated Growth Hormone group and As-Treated No Growth Hormone.||||>0.999
71771343|NCT02043379|143042459|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of \<0.05 represents the threshold for statistical significance|t-test, 2 sided|||24 hour post-operative max||||0.79
71771344|NCT00491556|143042465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.08|STANDARD_DEVIATION|5.13|<|0.0001|TWO_SIDED|95.0|-12.2|-7.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-7.97|-12.20|<0.0001
71661154|NCT00191113|142835878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.492||||0.419||95.0|-8.631|3.646|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||3.646|-8.631|0.419
71661155|NCT00191113|142835880|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||Fisher Exact|||||||0.545
71728939|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.95|||||TWO_SIDED|95.0|0.89|1.02||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.02|0.89|
71728940|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.9|||||TWO_SIDED|95.0|0.84|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||0.97|0.84|
71728941|NCT02214225|142972922|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|1.03|||||TWO_SIDED|95.0|0.94|1.14||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.||1.14|0.94|
71728942|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-2.1|||||TWO_SIDED|95.0|-6.9|2.6||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.6|-6.9|
71728943|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-4.6|||||TWO_SIDED|95.0|-9.3|0.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||0.2|-9.3|
71728944|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-4.5|||||TWO_SIDED|95.0|-10.3|1.3||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.3|-10.3|
71728945|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-4.6|||||TWO_SIDED|95.0|-10.5|1.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||1.2|-10.5|
71728946|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-0.2|||||TWO_SIDED|95.0|-4.4|4.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||4.0|-4.4|
71728947|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|1.1|||||TWO_SIDED|95.0|-3.1|5.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||5.2|-3.1|
71728948|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-2.2|||||TWO_SIDED|95.0|-6.3|2.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||2.0|-6.3|
71728949|NCT02214225|142972923|NON_INFERIORITY_OR_EQUIVALENCE|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|1.2|||||TWO_SIDED|95.0|-3.7|6.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.||6.2|-3.7|
71728950|NCT02214225|142972924|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) overall|1.47|||||TWO_SIDED|95.0|1.38|1.57|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.57|1.38|
71831112|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9557|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.20|0.84|0.9557
71831113|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8553|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40||1.22|0.85|0.8553
71771345|NCT00491556|143042466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_DEVIATION|5.0||0.0834|TWO_SIDED|95.0|-3.87|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||0.26|-3.87|0.0834
71771346|NCT00491556|143042467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-317.36|STANDARD_DEVIATION|176.07|<|0.0001|TWO_SIDED|95.0|-390.04|-244.68|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||-244.68|-390.04|<0.0001
71771347|NCT00491556|143042468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|242.38||0.6222|TWO_SIDED|95.0|-124.25|75.85|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||75.85|-124.25|0.6222
71771348|NCT00491556|143042469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.79|STANDARD_DEVIATION|152.57||0.0781|TWO_SIDED|95.0|-124.77|7.18|||t-test, 2 sided|||Null hypothesis is no changes between Baseline and Week 48.||7.18|-124.77|0.0781
71771349|NCT00491556|143042470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.53|STANDARD_DEVIATION|176.61||0.0102|TWO_SIDED|95.0|-179.9|-27.16|||t-test, 2 sided|||Null hypothesis is no changes between Week 48 and Week 152||-27.16|-179.90|0.0102
71728951|NCT02214225|142972924|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) overall|1.57|||||TWO_SIDED|95.0|1.45|1.7|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.70|1.45|
71771350|NCT00491556|143042471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.13|STANDARD_DEVIATION|56.72||0.1616|TWO_SIDED|95.0|-41.66|7.4|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.||7.40|-41.66|0.1616
71771351|NCT00491556|143042472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.08|STANDARD_DEVIATION|75.17||0.0117|TWO_SIDED|95.0|-75.59|-10.58|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||-10.58|-75.59|0.0117
71771352|NCT00491556|143042473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-76.92|STANDARD_DEVIATION|56.31|<|0.0001|TWO_SIDED|95.0|-101.27|-52.57|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Week 48 and Week 152||-52.57|-101.27|< 0.0001
71771353|NCT00491556|143042474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.87|STANDARD_DEVIATION|68.75||0.2519|TWO_SIDED|95.0|-12.86|46.6|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152||46.60|-12.86|0.2519
71771354|NCT00491556|143042475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.79|STANDARD_DEVIATION|105.61|<|0.0001|TWO_SIDED|95.0|-172.46|-81.12|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-81.12|-172.46|< 0.0001
71771355|NCT00491556|143042476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.64|STANDARD_DEVIATION|97.71||0.0003|TWO_SIDED|95.0|45.39|129.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||129.90|45.39|0.0003
71771356|NCT00491556|143042477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.46|STANDARD_DEVIATION|213.77||0.3739|TWO_SIDED|95.0|-51.98|132.9|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||132.90|-51.98|0.3739
71771357|NCT00491556|143042478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.86|STANDARD_DEVIATION|166.4||0.0147|TWO_SIDED|95.0|-163.82|-19.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-19.90|-163.82|0.0147
71771358|NCT00491556|143042479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.81|STANDARD_DEVIATION|76.07|<|0.0001|TWO_SIDED|95.0|46.92|112.71|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||112.71|46.92|< 0.0001
71771359|NCT00491556|143042480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_DEVIATION|58.18||0.1067|TWO_SIDED|95.0|-45.56|4.76|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||4.76|-45.56|0.1067
71771360|NCT00491556|143042481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.82|STANDARD_DEVIATION|107.8||0.0005|TWO_SIDED|95.0|44.2|137.43|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||137.43|44.20|0.0005
71771361|NCT00491556|143042482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.49|STANDARD_DEVIATION|64.41||0.0207|TWO_SIDED|95.0|5.64|61.34|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||61.34|5.64|0.0207
71771362|NCT00491556|143042483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.37|STANDARD_DEVIATION|145.62||0.2082|TWO_SIDED|95.0|-102.34|23.6|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Week 48 and Week 152.||23.60|-102.34|0.2082
71771363|NCT00491556|143042484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.98|STANDARD_DEVIATION|139.33||0.0067|TWO_SIDED|95.0|26.73|147.23|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||147.23|26.73|0.0067
71771364|NCT00491556|143042485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.07|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|-23.78|-12.36|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-12.36|-23.78|< 0.0001
71771365|NCT00491556|143042486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|14.2||0.5815|TWO_SIDED|95.0|-4.48|7.8|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||7.80|-4.48|0.5815
71661156|NCT00191113|142835882|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71728952|NCT02214225|142972924|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) 18 through 64 years|1.67|||||TWO_SIDED|95.0|1.5|1.87|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.87|1.50|
71728953|NCT02214225|142972924|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) 18 through 64 years|1.76|||||TWO_SIDED|95.0|1.55|2.01|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||2.01|1.55|
71728954|NCT02214225|142972924|SUPERIORITY_OR_OTHER||GMT ratio (B/YAM) ≥ 65 years|1.3|||||TWO_SIDED|95.0|1.21|1.4|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.40|1.21|
71728955|NCT02214225|142972924|SUPERIORITY_OR_OTHER||GMT ratio (B/VIC) ≥ 65 years|1.38|||||TWO_SIDED|95.0|1.27|1.51|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.||1.51|1.27|
71728956|NCT02214225|142972925|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) overall|15.3|||||TWO_SIDED|95.0|12.1|18.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||18.6|12.1|
71728957|NCT02214225|142972925|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) overall|20.1|||||TWO_SIDED|95.0|16.5|23.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||23.6|16.5|
71728958|NCT02214225|142972925|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) 18 through 64y|22.9|||||TWO_SIDED|95.0|17.7|28.2|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||28.2|17.7|
71728959|NCT02214225|142972925|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) 18 through 64y|28.6|||||TWO_SIDED|95.0|23.1|34.1|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||34.1|23.1|
71728960|NCT02214225|142972925|SUPERIORITY_OR_OTHER||Difference in SCR (B/YAM) ≥ 65 years|8.0|||||TWO_SIDED|95.0|4.3|11.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage||11.6|4.3|
71728961|NCT02214225|142972925|SUPERIORITY_OR_OTHER||Difference in SCR (B/VIC) ≥ 65 years|11.9|||||TWO_SIDED|95.0|7.7|16.0|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was \> 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to \< 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.||16.0|7.7|
71728962|NCT00787930|142972972|SUPERIORITY_OR_OTHER||||||>|0.05||||||a priori threshold for significance was 0.05|Chi-squared|||||||>0.05
71728963|NCT00787930|142972973|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|df=1||||||1.00
71728964|NCT00787930|142972974|SUPERIORITY_OR_OTHER|||||||0.6056||||||No adjustment for multiple comparisons|Chi-squared|df=1||||||0.6056
71771366|NCT00491556|143042487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.24|STANDARD_DEVIATION|7.82|<|0.0001|TWO_SIDED|95.0|7.85|14.62|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||14.62|7.85|< 0.0001
71771367|NCT00491556|143042488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_DEVIATION|6.93||0.0594|TWO_SIDED|95.0|-5.87|0.12|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.12|-5.87|0.0594
71771368|NCT00491556|143042489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.58|STANDARD_DEVIATION|10.24||0.0001|TWO_SIDED|95.0|8.15|17.01|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.01|8.15|0.0001
71771369|NCT00491556|143042490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93|STANDARD_DEVIATION|10.95||0.0995|TWO_SIDED|95.0|-0.81|8.66|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||8.66|-0.81|0.0995
71771370|NCT00491556|143042491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|2.07||0.0002|TWO_SIDED|95.0|1.05|2.84|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||2.84|1.05|0.0002
71771371|NCT00491556|143042492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|1.49||0.915|TWO_SIDED|95.0|-0.61|0.68|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.68|-0.61|0.9150
71771372|NCT00491556|143042493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.52|STANDARD_DEVIATION|13.79|<|0.0001|TWO_SIDED|95.0|-29.48|-17.55|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.55|-29.48|< 0.0001
71771373|NCT00491556|143042494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_DEVIATION|16.96||0.5864|TWO_SIDED|95.0|-5.38|9.28|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||9.28|-5.38|0.5864
71771374|NCT00491556|143042495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.98|STANDARD_DEVIATION|8.48|<|0.0001|TWO_SIDED|95.0|18.31|25.65|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||25.65|18.31|< 0.0001
71771375|NCT00491556|143042496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|7.25||0.1592|TWO_SIDED|95.0|-5.34|0.93|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.93|-5.34|0.1592
71771376|NCT00491556|143042497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_DEVIATION|11.04||0.042|TWO_SIDED|95.0|0.2|9.74|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||9.74|0.20|0.0420
71771377|NCT00491556|143042498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|12.39||0.4029|TWO_SIDED|95.0|-7.56|3.16|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||3.16|-7.56|0.4029
71771378|NCT00491556|143042499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_DEVIATION|6.03|<|0.0001|TWO_SIDED|95.0|11.99|17.21|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.21|11.99|< 0.0001
71771379|NCT00491556|143042500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.14|STANDARD_DEVIATION|6.2||0.0239|TWO_SIDED|95.0|-5.81|-0.46|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.46|-5.81|0.0239
71771380|NCT00491556|143042501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.35|STANDARD_DEVIATION|10.26|<|0.0001|TWO_SIDED|95.0|-23.79|-14.91|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-14.91|-23.79|< 0.0001
71771381|NCT00491556|143042502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.6||0.2363|TWO_SIDED|95.0|-9.33|2.43|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||2.43|-9.33|0.2363
71771382|NCT00491556|143042503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.69|STANDARD_DEVIATION|8.7|<|0.0001|TWO_SIDED|95.0|15.93|23.45|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||23.45|15.93|< 0.0001
71771383|NCT00491556|143042504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|5.55||0.0929|TWO_SIDED|95.0|-4.43|0.37|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.37|-4.43|0.0929
71771384|NCT00491556|143042505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|STANDARD_DEVIATION|8.94||0.1886|TWO_SIDED|95.0|-6.4|1.34|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||1.34|-6.40|0.1886
71771385|NCT00491556|143042506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87|STANDARD_DEVIATION|8.13||0.2831|TWO_SIDED|95.0|-1.65|5.38|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.38|-1.65|0.2831
71771386|NCT00491556|143042507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.52|STANDARD_DEVIATION|5.59|<|0.0001|TWO_SIDED|95.0|9.1|13.94|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||13.94|9.10|< 0.0001
71771387|NCT00491556|143042508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.21|STANDARD_DEVIATION|5.88||0.0157|TWO_SIDED|95.0|-5.75|-0.67|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.67|-5.75|0.0157
71771388|NCT00491556|143042509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.65|STANDARD_DEVIATION|12.93|<|0.0001|TWO_SIDED|95.0|-28.24|-17.06|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||-17.06|-28.24|< 0.0001
71771389|NCT00491556|143042510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|15.37||0.1999|TWO_SIDED|95.0|-2.41|10.88|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||10.88|-2.41|0.1999
71728965|NCT00787930|142972975|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory hypothesis|t-stat estimated value|1.52|STANDARD_DEVIATION|8.2||0.081|ONE_SIDED|95.0|0.0||||t-test, 1 sided|missing values: 6 df=7|||||0|0.081
71728966|NCT00787930|142972976|NON_INFERIORITY_OR_EQUIVALENCE|Exploratory analyses|t-stat estimated value|1.47|STANDARD_DEVIATION|6.56||0.091|ONE_SIDED|95.0|0.0|||no adjustment for multiple analyses|t-test, 1 sided|missing values: 5 df=7|||||0|0.091
71728967|NCT01049802|142972988|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71728968|NCT01049802|142972989|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71728969|NCT01049802|142972990|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71728970|NCT01049802|142972991|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71728971|NCT01049802|142972992|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71728972|NCT00823212|142972997|NON_INFERIORITY_OR_EQUIVALENCE|A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value \<0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.|Difference in percent of participants|0.5||||0.001|ONE_SIDED|95.0||2.13|||Farrington-Manning test||The standard error for the difference was estimated according to the Farrington-Manning test.|Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.||2.13||0.001
71888768|NCT05900115|143298634|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|0.0|STANDARD_ERROR_OF_MEAN|0.05||1|TWO_SIDED||||||Regression, Linear|||||||1.00
71888769|NCT00880750|143298648|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).|Mean Difference (Final Values)|-1.35|||||TWO_SIDED|90.0|-2.18|-0.51|||Mixed Models Analysis|||||-0.51|-2.18|
71661157|NCT00191113|142835884|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71728973|NCT03500172|142973042|SUPERIORITY|||||||0.455||||||Threshold for significance: 0.05|Two sample test of proportions|||||||0.455
71728974|NCT03500172|142973043|SUPERIORITY|||||||0.962||||||Statistical significance threshold: 0.05|Two sample test of proportions|||||||0.962
71728975|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.05|TWO_SIDED|95.0|0.61|0.99||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for steady partner, living together vs. single.||0.99|0.61|<0.05
71728976|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|1.6|||<|0.05|TWO_SIDED|95.0|1.02|2.51||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for 5-9 new clients in the past month vs. 0 clients in the past month.||2.51|1.02|<0.05
71728977|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|1.31|||<|0.05|TWO_SIDED|95.0|1.09|1.57||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU for use of marijuana in the past 30 days vs. no marijuana use in the past 30 days||1.57|1.09|<0.05
71728978|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|1.24|||<|0.05|TWO_SIDED|95.0|1.01|1.52||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those experiencing physical violence in the past 6 months vs. no experience of physical violence in the past 6 months.||1.52|1.01|<0.05
71728979|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|1.62|||<|0.05|TWO_SIDED|95.0|1.31|2.0||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those who have experienced sexual violence in the past 6 months vs. those who have not||2.00|1.31|<0.05
71728980|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|2.33|||<|0.05|TWO_SIDED|95.0|1.65|3.29||Threshold for statistical significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral loads from 50-1000 copies/mL at baseline vs. \<50 copies/mL.||3.29|1.65|<0.05
71728981|NCT03500172|142973044|SUPERIORITY||Hazard Ratio (HR)|2.47|||<|0.05|TWO_SIDED|95.0|1.82|3.36||Threshold for significance: 0.05|Regression, Cox|||Statistical test for risk of LTFU among those with viral load greater than 1000 copies/mL vs. those with viral load less than 50 copies/mL.||3.36|1.82|<0.05
71728982|NCT03500172|142973045|SUPERIORITY|||||||0.756||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.756
71728983|NCT03500172|142973046|SUPERIORITY|||||||0.295||||||Threshold of statistical significance: 0.05|Two sample test of proportions|||||||0.295
71728984|NCT03500172|142973047|SUPERIORITY|||||||0.149||||||Threshold for statistical significance: 0.05|Two sample test of proportions|||||||0.149
71728985|NCT03500172|142973048|SUPERIORITY|||||||0.301||||||Threshold of significance: 0.05|Two sample test of proportions|||||||0.301
71728986|NCT03500172|142973051|SUPERIORITY|||||||0.212||||||Threshold of statistical significance: 0.05|Chi-squared|||||||0.212
71728987|NCT04754230|142973056|OTHER|||||||0.8|||||||two sided Z-test|This estimate uses two sided Z-test while assuming type I error=0.05||Comparison of bleeding at day 1||||0.8
71728988|NCT00445848|142973091|OTHER||proportion of participants|0.78|||||TWO_SIDED|95.0|0.67|0.85||||||The overall survival rate at year 1 was estimated using Kaplan-Meier.||0.85|0.67|
71728989|NCT00445848|142973091|OTHER||proportion of participants|0.57|||||TWO_SIDED|95.0|0.46|0.67||||||The overall survival rate at year 2 was estimated using Kaplan-Meier.||0.67|0.46|
71728990|NCT00445848|142973091|OTHER||proportion of participants|0.43|||||TWO_SIDED|95.0|0.32|0.53||||||The overall survival rate at year 3 was estimated using Kaplan-Meier.||0.53|0.32|
71728991|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5||||||Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.5|-1.6|
71728992|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71728993|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.3|||||TWO_SIDED|95.0|-4.7|1.9||||||Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.9|-4.7|
71728994|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71728995|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71888770|NCT00880750|143298649|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).|Mean Difference (Final Values)|-1.98|||||TWO_SIDED|90.0|-3.17|-0.8|||Mixed Models Analysis|||||-0.80|-3.17|
71728996|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|-1.2|||||TWO_SIDED|95.0|-3.6|0.8||||||Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||0.8|-3.6|
71728997|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71728998|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71728999|NCT01323270|142973112|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.||1.1|-1.1|
71729000|NCT03242772|142973147|OTHER|||||||0.2664||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -3.5729 - 11.6929|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.2664
71729001|NCT03242772|142973148|OTHER|||||||0.3721||||||Significance at \<0.05|95% confidence interval|confidence interval (CI) = -17.7698 - 7.2698|||Presentation of results will include p-values and 95% confidence intervals for the least mean square values at weeks 0, 10, 24 (week 24 is exploratory).|||0.3721
71729002|NCT01310400|142973150|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|4.5||||0.0036|TWO_SIDED|95.0|1.4|7.5||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||7.5|1.4|0.0036
71729003|NCT01310400|142973150|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|-3.0||||0.1465|TWO_SIDED|95.0|-7.0|1.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.||1.0|-7.0|0.1465
71729004|NCT01310400|142973150|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|8.0|||<|0.001|TWO_SIDED|95.0|3.3|12.7||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||12.7|3.3|<0.001
71729005|NCT01310400|142973150|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|0.9||||0.7493|TWO_SIDED|95.0|-4.5|6.2||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.||6.2|-4.5|0.7493
71729006|NCT01310400|142973150|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|20.2||||0|TWO_SIDED|95.0|13.5|27.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||27.0|13.5|0.0000
71738999|NCT00620113|142990737|SUPERIORITY_OR_OTHER||Difference in LS Means|-26.86|||<|0.001|TWO_SIDED|95.0|-43.3|-10.42||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-10.42|-43.30|<0.001
71771390|NCT00491556|143042511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.47|STANDARD_DEVIATION|6.81|<|0.0001|TWO_SIDED|95.0|9.52|15.41|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||15.41|9.52|< 0.0001
71771391|NCT00491556|143042512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_DEVIATION|5.12||0.0808|TWO_SIDED|95.0|-4.17|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||0.26|-4.17|0.0808
71771392|NCT00491556|143042513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_DEVIATION|13.83||0.0005|TWO_SIDED|95.0|5.72|17.69|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||17.69|5.72|0.0005
71771393|NCT00491556|143042514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|14.12||0.9198|TWO_SIDED|95.0|-6.41|5.81|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||5.81|-6.41|0.9198
71771394|NCT00491556|143042515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|STANDARD_DEVIATION|2.97|<|0.0001|TWO_SIDED|95.0|2.4|4.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.||4.97|2.40|< 0.0001
71771395|NCT00491556|143042516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_DEVIATION|2.54||0.0215|TWO_SIDED|95.0|-2.41|-0.21|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.||-0.21|-2.41|0.0215
71771396|NCT04854642|143042525|OTHER||Least square mean difference|71.62|||<|0.0001|TWO_SIDED|90.0|68.13|75.29|||ANOVA|||||75.29|68.13|<0.0001
71771397|NCT04854642|143042526|OTHER||Least square mean difference|90.93||||0.017|TWO_SIDED|90.0|85.3|96.93|||ANOVA|||||96.93|85.30|0.0170
71771398|NCT04854642|143042527|OTHER||Least square mean difference|90.9||||0.0213|TWO_SIDED|90.0|85.04|97.16|||ANOVA|||||97.16|85.04|0.0213
71771399|NCT04854642|143042528|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71771400|NCT00562627|143042543|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA|||||||0.009
71771401|NCT00562627|143042544|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
71771402|NCT00562627|143042545|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71771403|NCT01709578|143042548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.711|||<|0.0001|TWO_SIDED|95.0|1.73|4.247||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||4.247|1.730|<0.0001
71771404|NCT01709578|143042548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.108|5.115||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.115|2.108|<0.0001
71771405|NCT01709578|143042549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.202||||0.0007|TWO_SIDED|95.0|-0.318|-0.086||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.086|-0.318|0.0007
71771406|NCT01709578|143042549|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.0004|TWO_SIDED|95.0|-0.325|-0.095||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.095|-0.325|0.0004
71771407|NCT01709578|143042550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.283|-0.658||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.658|-1.283|<0.0001
71831114|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9901|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.20|0.84|0.9901
71771408|NCT01709578|143042550|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.444|||<|0.0001|TWO_SIDED|95.0|-1.752|-1.135||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.135|-1.752|<0.0001
71771409|NCT01709578|143042551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958|||<|0.0001|TWO_SIDED|95.0|1.764|4.959||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.959|1.764|<0.0001
71729007|NCT01310400|142973150|NON_INFERIORITY_OR_EQUIVALENCE|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|10.7||||0.0029|TWO_SIDED|95.0|3.7|17.6||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.||17.6|3.7|0.0029
71729008|NCT01062841|142973154|SUPERIORITY_OR_OTHER||Rate Ratio|0.77|||<|0.05|TWO_SIDED|95.0|0.62|0.94||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.94|0.62|<0.05
71729009|NCT01062841|142973155|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.54||||0.04|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||0.97|0.30|0.04
71729010|NCT01062841|142973156|SUPERIORITY_OR_OTHER||Rate Ratio|0.78|||<|0.05|TWO_SIDED|95.0|0.64|0.96||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.96|0.64|<0.05
71729011|NCT01062841|142973157|SUPERIORITY_OR_OTHER||Rate Ratio|1.2|||>|0.05|TWO_SIDED|95.0|0.82|1.75||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.75|0.82|>0.05
71729012|NCT01062841|142973158|SUPERIORITY_OR_OTHER||Rate Ratio|0.94|||>|0.05|TWO_SIDED|95.0|0.61|1.44||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||1.44|0.61|>0.05
71729013|NCT01062841|142973159|SUPERIORITY_OR_OTHER||Rate Ratio|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.97||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.||0.97|0.58|<0.05
71729014|NCT01062841|142973161|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.09||||0.92|TWO_SIDED|95.0|0.22|5.45|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||5.45|0.22|0.92
71729015|NCT01062841|142973162|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.83||||0.34|TWO_SIDED|95.0|0.53|6.31|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.||6.31|0.53|0.34
71729016|NCT01062841|142973163|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.01|TWO_SIDED|95.0|0.65|0.95|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||0.95|0.65|0.01
71729017|NCT01062841|142973164|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85||||0.61|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual's risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.||1.60|0.45|0.61
71729018|NCT01062841|142973165|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.59|TWO_SIDED|95.0|0.6|1.33|||Regression, Cox|||||1.33|0.60|0.59
71729019|NCT01118520|142973166|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||0.78
71729020|NCT01118520|142973166|SUPERIORITY|||||||0.89|||||||Mixed Models Analysis|||||||0.89
71771410|NCT01709578|143042551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.374|||<|0.0001|TWO_SIDED|95.0|2.045|5.566||Threshold for significance was 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.566|2.045|<0.0001
71771411|NCT01709578|143042552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.607||||0.0002|TWO_SIDED|95.0|1.774|7.332||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.332|1.774|0.0002
71771412|NCT01709578|143042552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.0056|TWO_SIDED|95.0|1.308|5.383||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.383|1.308|0.0056
71771413|NCT01709578|143042553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.622|||<|0.0001|TWO_SIDED|95.0|2.339|9.132||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9.132|2.339|<0.0001
71771414|NCT01709578|143042553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.801|||<|0.0001|TWO_SIDED|95.0|2.948|11.413||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.413|2.948|<0.0001
71771415|NCT01709578|143042554|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.306|||<|0.0001|TWO_SIDED|95.0|-10.444|-4.167||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.167|-10.444|<0.0001
71771416|NCT01709578|143042554|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.727|||<|0.0001|TWO_SIDED|95.0|-12.833|-6.622||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.622|-12.833|<0.0001
71771417|NCT01709578|143042555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.183||||0.0078|TWO_SIDED|95.0|-0.318|-0.048||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.048|-0.318|0.0078
71771418|NCT01709578|143042555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.242||||0.0004|TWO_SIDED|95.0|-0.376|-0.109||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-0.109|-0.376|0.0004
71888771|NCT00880750|143298650|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.34||||||90.0|1.26|1.42|||Mixed Models Analysis|After application of the log transformation AUC 0-48 was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.42|1.26|
71771419|NCT01709578|143042556|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25||||0.0004|TWO_SIDED|95.0|1.45|5.049||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.049|1.450|0.0004
71771420|NCT01709578|143042556|SUPERIORITY_OR_OTHER||LS Mean Difference|4.075|||<|0.0001|TWO_SIDED|95.0|2.305|5.846||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.846|2.305|<0.0001
71771421|NCT01709578|143042557|SUPERIORITY_OR_OTHER||LS Mean Difference|1.515||||0.2026|TWO_SIDED|95.0|-0.818|3.848||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3.848|-0.818|0.2026
71771422|NCT01709578|143042557|SUPERIORITY_OR_OTHER||LS Mean Difference|2.013||||0.0854|TWO_SIDED|95.0|-0.282|4.309||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.309|-0.282|0.0854
71771423|NCT00988325|143042621|SUPERIORITY_OR_OTHER||Median time to cessation of viral sheddi|119.0|||=|0.166|TWO_SIDED|95.0|113.0|230.0||p-value is for the comparison of the age cohorts (treatment groups)|Wilcoxon (Mann-Whitney)|Wilcoxon Test was used for testing homogeneity of survival curves|Median time was estimated from the Kaplan-Meier curve (unstratified)|||230|113|=0.166
71771424|NCT00988325|143042623|SUPERIORITY_OR_OTHER||Time to Resolution of Fever in Patients|14.5|||=|0.059|TWO_SIDED|95.0|12.0|20.0||The p-value is for the comparison of the age cohorts (not including Total)|Wilcoxon (Mann-Whitney)||Median time was estimated from the Kaplan-Meier curve (unstratified)|||20|12|=0.059
71771425|NCT01314911|143042638|SUPERIORITY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|4.6||0.0097|TWO_SIDED|95.0|-21.4|-3.0||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Oseltamivir arm minus the percent detectable in the Placebo arm.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Oseltamivir arm was better than the placebo arm and that the detectable rate in the Oseltamivir arm was 42.5% compared to 57.5% in the placebo arm (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-3.0|-21.4|0.0097
71771426|NCT01314911|143042641|SUPERIORITY|||||||0.0243||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.0243
71729021|NCT01089023|142973179|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
71729022|NCT01089023|142973180|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA|||||||<0.0001
71729023|NCT03410797|142973182|OTHER|Due to small sample size, nonparametric Wilcoxon signed-rank tests were used to compare VHI-10 before and after therapy.|Median Difference (Net)|7.0||||0.0076|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Descriptive statistics characterized this patient perception measurement.||||.0076
71729024|NCT03410797|142973183|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Final Values)|-1.53||||0.0329|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0329
71729025|NCT03410797|142973184|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|15.39||||0.0164|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0164
71729026|NCT03410797|142973185|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-52.0||||0.1141|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1141
71729027|NCT03410797|142973186|OTHER|Descriptive statistics characterized acoustic and aerodynamic measures, and patient perception measurements.|Median Difference (Net)|-1.7||||0.3329|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3329
71729028|NCT01185964|142973188|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.0615|TWO_SIDED|95.0|0.442|1.021|||Log Rank|||||1.021|0.442|0.0615
71729029|NCT01185964|142973191|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.463||||0.0003|TWO_SIDED|95.0|0.301|0.71|||Log Rank|||||0.710|0.301|0.0003
71771427|NCT01314911|143042642|SUPERIORITY|||||||0.41||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.41
71771428|NCT01314911|143042643|SUPERIORITY|||||||0.88||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.88
71771429|NCT01314911|143042644|SUPERIORITY|||||||0.7461||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.7461
71729030|NCT01920893|142973199|SUPERIORITY||Least Square (LS) mean difference|-1.55||||0.0009|TWO_SIDED|95.0|-2.43|-0.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg QW vs Placebo|Analysis was performed by a mixed model repeated measures (MMRM) model.||-0.67|-2.43|0.0009
71729031|NCT05894538|142973215|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
71729032|NCT05894538|142973216|SUPERIORITY|Due to the low event rate, a posterior probability was not estimated.|Hazard Ratio (HR)|3.57|||||TWO_SIDED|95.0|0.74|17.18|||||Low event rate precluded covariate adjustment.|||17.18|0.74|
71771430|NCT01314911|143042645|SUPERIORITY|||||||0.1501||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.1501
71771431|NCT01314911|143042646|SUPERIORITY|||||||0.3025||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.3025
71771432|NCT01314911|143042647|SUPERIORITY|||||||0.5466||||||P-value was not adjusted for multiple interim analyses.|Log Rank|||||||0.5466
71771433|NCT01314911|143042649|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5311|TWO_SIDED|95.0|-1.4|3.0||P-value was not adjusted for multiple interim analyses.|two-sample binomial exact test|The two-sample binomial exact test was performed in PROC STATXACT.|The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|||3.0|-1.4|0.5311
71831115|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|0.95||||0.587|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48||1.14|0.80|0.5870
71729033|NCT05894538|142973219|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.45|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.45|0.60|
71729034|NCT05894538|142973223|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.96|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||0.96|0.61|
71729035|NCT05894538|142973223|OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.49|0.85|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||0.85|0.49|
71729036|NCT05894538|142973223|OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||0.92|0.52|
71729037|NCT05894538|142973223|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.72|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.36|0.72|
71729038|NCT05894538|142973224|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|1.03|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.56|1.03|
71771434|NCT01314911|143042650|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8498|TWO_SIDED|95.0|-3.8|4.7||P-value was not adjusted for multiple interim analyses.|Z test||The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|This test compared the difference in percentages of participants with at least one complication between two randomized arms.||4.7|-3.8|0.8498
71771435|NCT01314911|143042652|SUPERIORITY||Mean Difference (Final Values)|-13.6||||0.0021|TWO_SIDED|95.0|-22.2|-5.1||P-value was not adjusted for multiple interim analyses.|Z test||||The difference in percents was calculated as the percent with detectable in the Oseltamivir arm minus the percent with detectable in the placebo arm.|-5.1|-22.2|0.0021
71729039|NCT05894538|142973224|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|1.00|
71729040|NCT05894538|142973224|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.35|0.87|
71771436|NCT01314911|143042655|SUPERIORITY|||||||0.022||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)|||||||0.022
71658675|NCT02731326|142832643|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05).|Hazard Ratio (HR)|1.56||||0.05|TWO_SIDED|95.0|1.06|2.3|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|The study was designed to have 80% power to detect a hazard ratio of 2 for recurrence detection (α = .05). Kaplan-Meier curves were created for recurrence detection in the intervention and control groups over the 6-month follow-up period. Differences in time to recurrence between groups were assessed using a Cox proportional hazards model. Baseline variables that differed significantly between groups were included as covariates and adjusted Kaplan-Meier curves were constructed.||2.30|1.06|0.05
71658676|NCT02731326|142832644|EQUIVALENCE|The study was designed to have 80% power to detect a hazard ratio of 2 (α = .05).|Hazard Ratio (HR)|0.33||||0.05|TWO_SIDED|95.0|0.09|0.58|||Regression, Cox||Treatment arm equals numerator. Control arm=denominator.|Kaplan-Meier curves were created for assessing time to treatment for intervention and control groups. Time to treatment was defined as the time interval from detection of a recurrent arrhythmia to treatment for that arrhythmia.||0.58|0.09|0.05
71658677|NCT02731326|142832645|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.58|||Regression, Cox|||||0.58|0.19|<.0001
71658678|NCT02731326|142832646|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71658679|NCT02731326|142832647|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
71658680|NCT04647721|142832672|NON_INFERIORITY|Non-inferiority margin of 0.5. The two-sided 95% confidence interval (CI) for the treatment difference was constructed using the repeated-measures analysis of covariance (ANCOVA).|Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.07|0.12||||||||0.12|-0.07|
71658681|NCT04647721|142832673|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.35|6.35||||||||6.35|-6.35|
71658682|NCT04647721|142832674|OTHER||Risk Difference (RD)|1.75|||||TWO_SIDED|95.0|-3.08|6.74||||||||6.74|-3.08|
71658683|NCT05070546|142832681|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\])|Geometric Mean Ratio|1.41|||||TWO_SIDED|95.0|1.25|1.6|||Geometric Mean Ratio|||||1.60|1.25|
71729041|NCT05894538|142973224|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.86|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.32|0.86|
71771437|NCT00403403|143042661|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0097||95.0|0.323|0.862|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.862|0.323|0.0097
71658684|NCT05070546|142832681|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\])|Geometric mean ratio|1.54|||||TWO_SIDED|95.0|1.34|1.78|||Geometric Mean Ratio|||||1.78|1.34|
71658685|NCT05070546|142832682|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 1\[Group1\] and 2 \[Group 3\]).|Difference in Seroresponse rate|5.4|||||TWO_SIDED|95.0|0.3|10.9|||Difference in Seroresponse rate|||||10.9|0.3|
71658686|NCT05070546|142832682|NON_INFERIORITY|Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 \[Group 5\]/Cohort 2 \[Group 3\]).|Difference in Seroresponse rate|4.4|||||TWO_SIDED|95.0|-1.6|10.5|||Difference in Seroresponse rate|||||10.5|-1.6|
71658687|NCT00302081|142832684|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.02||||0.041||95.0|-0.1|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks)\]-\[PEG2b 1.5/R(24 weeks)\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 1.5-dose group and 0.643 (144/224 subjects) in the 1.0-dose group, for a risk difference of -0.02.||This is an evaluation of the effect of the peginterferon alfa-2b dose (1.0 vs 1.5 micrograms/kg/week) on the primary outcome measure.||1|-0.10|0.041
71658688|NCT00302081|142832684|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.1||||0.495||95.0|-0.17|1.0||The Hochberg procedure was used to adjust for the multiple comparisons (\[PEG2b 1.0/R(24 weeks)\] - \[PEG2b 1.5/R(24 weeks\]) and (\[PEG2b 1.5/R(16 weeks\]-\[PEG2b 1.5/R(24 weeks\]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 24-week group and 0.566 (129/228 subjects) in the 16-week group, for a risk difference of -0.10.||This is an evaluation of the effect of treatment duration (24 weeks vs 16 weeks) on the primary outcome measure.||1|-0.17|0.495
71771438|NCT00403403|143042662|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6054|TWO_SIDED|95.0|0.66|2.039|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||2.039|0.660|0.6054
71771439|NCT00403403|143042663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.3269||95.0|-9.6|29.0|||Chi-squared|||||29.0|-9.6|0.3269
71831116|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8302|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.22|0.85|0.8302
71831117|NCT02528188|143167428|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4823|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56||1.12|0.79|0.4823
71729042|NCT05894538|142973225|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.26|0.81|
71831118|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.11||||0.2938|TWO_SIDED|95.0|0.92|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.33|0.92|0.2938
71831119|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.91||||0.3146|TWO_SIDED|95.0|0.75|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=30% reduction||1.10|0.75|0.3146
71888772|NCT00880750|143298651|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric LS means|1.26||||||90.0|1.2|1.33|||Mixed Models Analysis|After application of the log transformation Cmax was analysed using a mixed effect linear model.||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.||1.33|1.20|
71658689|NCT00535587|142832763|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.94|<|0.02|TWO_SIDED|95.0|||||ANCOVA|||||||<0.02
71729043|NCT05894538|142973225|OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|1.0|1.66|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.66|1.00|
71729044|NCT05894538|142973225|OTHER||Odds Ratio (OR)|1.52|||||TWO_SIDED|95.0|1.15|2.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||2.02|1.15|
71729045|NCT05894538|142973225|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.47|0.86|
71729046|NCT05894538|142973226|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.76|
71729047|NCT05894538|142973226|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.30|0.75|
71729048|NCT05894538|142973226|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.25|0.72|
71831120|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0748|TWO_SIDED|95.0|0.98|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.58|0.98|0.0748
71888773|NCT00880750|143298652|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.01||||||90.0|0.0|0.5|||Wilcoxon (Hodges-Lehmann)|The median difference and 90% CI for the median difference was then calculated based on Hodges-Lehmann estimate for Wilcoxon's Signed Rank test||||0.50|0.00|
71729049|NCT05894538|142973226|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.28|0.75|
71831121|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=50% reduction||1.45|0.89|0.3000
71831122|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.23||||0.255|TWO_SIDED|95.0|0.86|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.74|0.86|0.2550
71658690|NCT01568320|142832767|SUPERIORITY_OR_OTHER_LEGACY||Freedom from Major adverse events (%)|71.6|||||TWO_SIDED|95.0|59.0|82.0|||||Clopper-Pearson (Exact) Method|||82|59|
71658691|NCT01568320|142832768|SUPERIORITY_OR_OTHER_LEGACY||Survival rate (%)|95.5|||||TWO_SIDED|95.0|87.0|99.0|||||Clopper-Pearson (Exact) Method|||99|87|
71729050|NCT05894538|142973227|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.33|0.84|
71729051|NCT05894538|142973227|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.87|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.43|0.87|
71729052|NCT05894538|142973227|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.91|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.55|0.91|
71729053|NCT05894538|142973227|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.26|0.75|
71771440|NCT00403403|143042665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.305||||0.0011|TWO_SIDED|95.0|0.144|0.644|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)|||0.644|0.144|0.0011
71771441|NCT00472459|143042676|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.514||||0.012|TWO_SIDED|95.0|0.116|0.911|||t-test, 2 sided||The 95 % confidence intervals for the lesion complete response rates and lesion recurrence rates were estimated using the method of Clopper and Pearson.|||0.911|0.116|0.0120
71771442|NCT00472459|143042677|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.413||||0.1761|TWO_SIDED|95.0|-0.19|1.016|||t-test, 2 sided|||||1.016|-0.190|0.1761
71771443|NCT00472459|143042678|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.6||||0.1183|TWO_SIDED|95.0|-0.156|1.357|||t-test, 2 sided|||||1.357|-0.156|0.1183
71888774|NCT00670007|143298657|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.279|||=|0.752|TWO_SIDED|95.0|-1.089|0.53||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval \[CI\] being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 \[CE1226\_4001\], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.530|-1.089|= 0.752
71771444|NCT00472459|143042679|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.493||||0.2322|TWO_SIDED|95.0|-0.323|1.309|||t-test, 2 sided|||||1.309|-0.323|0.2322
71771445|NCT00472459|143042680|NON_INFERIORITY|Participant's number of new skin lesions between treated and contralateral control area were evaluated using a paired t-test for lesions of any type as well as stratified by lesion type.|Mean Difference (Final Values)|0.68||||0.1286|TWO_SIDED|95.0|-0.202|1.562|||t-test, 2 sided|||||1.562|-0.202|0.1286
71771446|NCT00478881|143042786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.045||||0.5293||95.0|-33.194|17.104||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P\<0.05.|ANCOVA||Placebo-Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||17.104|-33.194|0.5293
71771447|NCT00478881|143042787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.668||||0.0575||95.0|-0.021|1.358||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P \<0.05.|ANCOVA||Placebo - Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.||1.358|-0.021|0.0575
71771448|NCT00478881|143042788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.657||||0.8533||95.0|-6.335|7.65||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||7.650|-6.335|0.8533
71771449|NCT00478881|143042789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59||||0.1539||95.0|-37.057|5.876||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||5.876|-37.057|0.1539
71729054|NCT05894538|142973228|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.20|0.79|
71729055|NCT05894538|142973228|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.63|1.02|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.02|0.63|
71729056|NCT05894538|142973228|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.69|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.69|
71729057|NCT05894538|142973228|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.35|0.84|
71729058|NCT05894538|142973229|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.19|0.78|
71729059|NCT05894538|142973229|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.92|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.39|0.92|
71729060|NCT05894538|142973229|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.91|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.36|0.91|
71729061|NCT05894538|142973229|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.82|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.82|
71729062|NCT05894538|142973230|SUPERIORITY||Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.39|0.32|||||The interval is a highest-density credible interval.|||0.32|-0.39|
71729063|NCT01396265|142973245|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.2|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|60.815|72.057|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.057|60.815|
71729064|NCT01396265|142973246|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|66.18|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|60.656|72.213|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||72.213|60.656|
71729065|NCT01396265|142973247|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|78.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|72.363|84.968|||ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||84.968|72.363|
71729066|NCT02081638|142973255|OTHER||||||>|0.05||||||Threshold for statistical significance was a priori set to \<0.05|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||>0.05
71771450|NCT00478881|143042790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.374||||0.2348||95.0|-32.834|8.087||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.087|-32.834|0.2348
71771451|NCT00478881|143042791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.195||||0.3289||95.0|-24.692|8.303||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||8.303|-24.692|0.3289
71771452|NCT00478881|143042792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.721||||0.0609||95.0|-0.033|1.476||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||1.476|-0.033|0.0609
71729067|NCT02081638|142973255|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.022
71729068|NCT02081638|142973256|OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.13
71729069|NCT02081638|142973256|OTHER|||||||0.097|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.097
71729070|NCT02081638|142973256|OTHER|||||||0.0269|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the change of sCD14 from baseline and month 12 measurement within each arm.||||0.0269
71729071|NCT02081638|142973256|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71729072|NCT02081638|142973256|OTHER||||||||||||||||||Plasma biomarkers (CRP, sCD14, TF, IL-6) were log(e) transformed and a linear mixed effect model with the biomarker as outcome and with random slope per participant was used to calculate the percentage of change from baseline.|||
71729073|NCT02275117|142973257|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|12.6||||0.033|TWO_SIDED|95.0|1.3|24.0|||Cochran-Mantel-Haenszel|||||24.0|1.3|0.0330
71729074|NCT02275117|142973257|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|10.7||||0.0715|TWO_SIDED|95.0|-0.5|21.8|||Cochran-Mantel-Haenszel|||||21.8|-0.5|0.0715
71729075|NCT02275117|142973257|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|7.5||||0.2013|TWO_SIDED|95.0|-3.5|18.5|||Cochran-Mantel-Haenszel|||||18.5|-3.5|0.2013
71729076|NCT02275117|142973257|SUPERIORITY|75% Migraine Responder Rate - Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|6.1||||0.2938|TWO_SIDED|95.0|-4.6|16.9|||Cochran-Mantel-Haenszel|||||16.9|-4.6|0.2938
71729077|NCT02680574|142973297|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change of hemoglobin: Vadadustat minus Darbepoetin alfa|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.042|||TWO_SIDED|95.0|-0.09|0.07||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.07|-0.09|
71729078|NCT02680574|142973298|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.3 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|1.16|||=|0.2015|TWO_SIDED|95.0|0.93|1.446|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.446|0.930|=0.2015
71729079|NCT02680574|142973298|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.17|||=|0.0725|TWO_SIDED|95.0|1.012|1.355|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 382 and 344 respectively; median time to first event (Q1, Q3) = 50.07 (23.00, 82.86) weeks versus 51.93 (27.79, 91.00) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.355|1.012|=0.0725
71729080|NCT02680574|142973299|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.09||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.09|-0.10|
71729081|NCT02680574|142973300|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.777|TWO_SIDED|95.0|0.851|1.268|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.268|0.851|=0.7770
71729082|NCT02680574|142973300|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.2305|TWO_SIDED|95.0|0.972|1.267|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first MACE plus hospitalization for heart failure or thromboembolic events excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 451 and 424 respectively; median time to first event (Q1, Q3) = 42.86 (19.71, 73.43) weeks versus 43.86 (21.36, 80.43) weeks, respectively.||1.267|0.972|=0.2305
71729083|NCT02680574|142973301|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.11|||=|0.5509|TWO_SIDED|95.0|0.817|1.501|||Gray's Test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.501|0.817|=0.5509
71729084|NCT02680574|142973301|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.16|||=|0.2531|TWO_SIDED|95.0|0.947|1.42|||Gray's Test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 198 and 178 respectively; median time to first event (Q1, Q3) = 45.57 (21.71, 73.29) weeks versus 47.36 (20.00, 88.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.420|0.947|=0.2531
71729085|NCT02680574|142973302|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|0.88|||=|0.4184|TWO_SIDED|95.0|0.61|1.258|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.258|0.610|=0.4184
71729086|NCT02680574|142973302|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.01|||=|0.8613|TWO_SIDED|95.0|0.792|1.293|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 127 and 131 respectively; median time to first event (Q1, Q3) = 48.29 (28.86, 76.14) weeks versus 48.43 (21.29, 92.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.293|0.792|=0.8613
71729087|NCT02680574|142973303|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8041|TWO_SIDED|95.0|0.82|1.315|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0015 has been reported in this section.||1.315|0.820|=0.8041
71729088|NCT02680574|142973303|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.3 (per EMA).|Hazard Ratio (HR)|1.09|||=|0.4577|TWO_SIDED|95.0|0.93|1.274|||Log Rank|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 319 and 307 respectively; median time to first event (Q1, Q3) = 52.14 (28.71, 84.71) weeks versus 53.00 (30.71, 94.14) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.274|0.930|=0.4577
71729089|NCT02847858|142973314|SUPERIORITY||Slope|1.16||||0.011|TWO_SIDED|95.0|0.26|2.07||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up||2.07|0.26|0.011
71729090|NCT02847858|142973314|SUPERIORITY||Slope|1.64|||<|0.001|TWO_SIDED|95.0|1.01|2.07||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||2.07|1.01|<0.001
71771453|NCT00478881|143042793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118||||0.4928||95.0|-0.22|0.456||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.456|-0.220|0.4928
71729091|NCT02847858|142973314|SUPERIORITY||Slope|0.48||||0.108|TWO_SIDED|95.0|-0.1|1.05||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome||1.05|-0.10|0.108
71729092|NCT02847858|142973315|SUPERIORITY||F statistic:Time X Arm Interaction|3.23||||0.04|TWO_SIDED|||||Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months||||0.04
71729093|NCT02847858|142973315|SUPERIORITY||Slope|0.82||||0.218|TWO_SIDED|95.0|-0.48|2.11||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site||Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months|Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline|2.11|-0.48|.218
71729094|NCT02847858|142973315|SUPERIORITY||Slope|1.58||||0.008|TWO_SIDED|95.0|0.38|2.77||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months||2.77|0.38|0.008
71729095|NCT02847858|142973316|SUPERIORITY||F statistic:Time X Arm Interaction|3.72||||0.025|TWO_SIDED|||||Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months||||0.025
71729096|NCT02847858|142973316|SUPERIORITY||Odds Ratio (OR)|3.29||||0.042|TWO_SIDED|95.0|1.04|10.36||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months||10.36|1.04|0.042
71729097|NCT02847858|142973316|SUPERIORITY||Odds Ratio (OR)|5.54||||0.005|TWO_SIDED|95.0|1.7|18.06||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months||18.06|1.7|0.005
71729098|NCT02847858|142973317|SUPERIORITY||Slope|1.62|||<|0.001|TWO_SIDED|95.0|1.43|1.82||Time main effect; a priori threshold for statistical significance p \<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is post-app minus pre-app|Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants||1.82|1.43|<0.001
71729099|NCT02847858|142973318|SUPERIORITY||Odds Ratio (OR)|2.22||||0.055|TWO_SIDED|95.0|0.98|5.01||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit||5.01|0.98|0.055
71771454|NCT00478881|143042794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823||||0.3248||95.0|-2.476|0.829||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||0.829|-2.476|0.3248
71771455|NCT00478881|143042795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.095||||0.5312||95.0|-4.533|2.342||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA|||ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.||2.342|-4.533|0.5312
71729100|NCT02847858|142973319|SUPERIORITY||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.78||Arm main effect; a priori threshold for statistical significance p\<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method||3.78|0.73|0.227
71771456|NCT00737464|143042797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|||||TWO_SIDED|||||||||||||
71771457|NCT03569293|143042837|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|63.4|||<|0.001|TWO_SIDED|95.0|57.1|69.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||69.8|57.1|<0.001
71729101|NCT02305849|142973337|SUPERIORITY||Percent Difference|36.9|||<|0.001|TWO_SIDED|95.0|26.7|47.0||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||47.0|26.7|<0.001
71729102|NCT02305849|142973337|SUPERIORITY||Percent difference|42.6|||<|0.001|TWO_SIDED|95.0|32.6|52.6||Closed testing procedure was used for multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution.|Treatment Difference vs Placebo||52.6|32.6|<0.001
71729103|NCT02305849|142973338|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on Rank Analysis of Covariance (RANCOVA) Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
71729104|NCT02305849|142973338|SUPERIORITY||||||<|0.001||||||Closed testing procedure was used for multiplicity adjustment.|RANCOVA|Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.||Treatment Difference vs Placebo||||<0.001
71729105|NCT02305849|142973340|SUPERIORITY||Percent Difference|22.2|||<|0.001|TWO_SIDED|95.0|13.8|30.7||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||30.7|13.8|<0.001
71729106|NCT02305849|142973340|SUPERIORITY||Percent Difference|38.3|||<|0.001|TWO_SIDED|95.0|29.3|47.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||47.3|29.3|<0.001
71729107|NCT02305849|142973342|SUPERIORITY||Percent Difference|9.7|||<|0.001|TWO_SIDED|95.0|3.8|15.6||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||15.6|3.8|<0.001
71729108|NCT02305849|142973342|SUPERIORITY||Percent Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.9|28.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.5|13.9|<0.001
71729109|NCT02305849|142973344|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
71729110|NCT02305849|142973344|SUPERIORITY||||||<|0.001||||||Based on RANCOVA Model: Rank of mTSS Change = Treatment + Baseline Rank of mTSS.|RANCOVA|||Treatment Difference vs Placebo||||<0.001
71729111|NCT02305849|142973345|SUPERIORITY|||||||0.018|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.018
71729112|NCT02305849|142973345|SUPERIORITY|||||||0.002|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN score.||Week 28/ET: Treatment Difference vs Placebo||||0.002
71729113|NCT02305849|142973345|SUPERIORITY|||||||0.039|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.039
71729114|NCT02305849|142973345|SUPERIORITY|||||||0.006|||||||RANCOVA|Based on RANCOVA Model: Rank of JSN Score Change = Treatment + Baseline Rank of JSN Score.||Week 52/ET: Treatment Difference vs Placebo||||0.006
71729115|NCT02305849|142973346|SUPERIORITY|||||||0.036|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||0.036
71729116|NCT02305849|142973346|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 28/ET: Treatment Difference vs Placebo||||<0.001
71729117|NCT02305849|142973346|SUPERIORITY|||||||0.013|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||0.013
71729118|NCT02305849|142973346|SUPERIORITY||||||<|0.001|||||||RANCOVA|Based on RANCOVA Model: Rank of Erosion Score Change = Treatment + Baseline Rank of Erosion Score.||Week 52/ET: Treatment Difference vs Placebo||||<0.001
71729119|NCT02305849|142973347|SUPERIORITY||Percent Difference|21.3|||<|0.001|TWO_SIDED|95.0|10.0|32.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||32.6|10.0|<0.001
71729120|NCT02305849|142973347|SUPERIORITY||Percent Difference|26.8|||<|0.001|TWO_SIDED|95.0|15.7|37.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 28/ET: Treatment Difference vs Placebo||37.9|15.7|<0.001
71729121|NCT02305849|142973347|SUPERIORITY||Percent Difference|21.5|||<|0.001|TWO_SIDED|95.0|10.2|32.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||32.9|10.2|<0.001
71729122|NCT02305849|142973347|SUPERIORITY||Percent Difference|26.4|||<|0.001|TWO_SIDED|95.0|15.2|37.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Week 52/ET: Treatment Difference vs Placebo||37.6|15.2|<0.001
71729123|NCT02305849|142973348|SUPERIORITY||LS Mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.46|-0.97||No multiplicity adjustment.|ANCOVA|Based on ANCOVA (analysis of covariance) Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.97|-1.46|<0.001
71729124|NCT02305849|142973348|SUPERIORITY||LS Mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.85|-1.33||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.33|-1.85|<0.001
71729125|NCT02305849|142973350|SUPERIORITY||LS Mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.44|-0.94||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-0.94|-1.44|<0.001
71729126|NCT02305849|142973350|SUPERIORITY||LS Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.89|-1.36||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: DAS28 Change = Treatment + Baseline DAS28.||Treatment Difference vs Placebo||-1.36|-1.89|<0.001
71729127|NCT02305849|142973352|SUPERIORITY||LS Mean difference|-5.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-6.9|-3.5||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-3.5|-6.9|<0.001
71729128|NCT02305849|142973352|SUPERIORITY||LS Mean difference|-7.2|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: TJC68 Change = Treatment + Baseline TJC68.||Treatment Difference vs Placebo||-5.6|-8.9|<0.001
71729129|NCT02305849|142973354|SUPERIORITY||LS Mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.3|-2.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-2.6|-5.3|<0.001
71729130|NCT02305849|142973354|SUPERIORITY||LS Mean difference|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-6.9|-4.3||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SJC66 Change = Treatment + Baseline SJC66.||Treatment Difference vs Placebo||-4.3|-6.9|<0.001
71729131|NCT02305849|142973356|SUPERIORITY||Percent Difference|23.7|||<|0.001|TWO_SIDED|95.0|15.1|32.3||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||32.3|15.1|<0.001
71729132|NCT02305849|142973356|SUPERIORITY||Percent Difference|27.4|||<|0.001|TWO_SIDED|95.0|18.6|36.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||36.2|18.6|<0.001
71729133|NCT02305849|142973358|SUPERIORITY||Percent Difference|10.4|||<|0.001|TWO_SIDED|95.0|4.3|16.5||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||16.5|4.3|<0.001
71729134|NCT02305849|142973358|SUPERIORITY||Percent Difference|16.9|||<|0.001|TWO_SIDED|95.0|10.0|23.9||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected)|Treatment Difference vs Placebo||23.9|10.0|<0.001
71729135|NCT02305849|142973360|SUPERIORITY||Percent Difference|34.7|||<|0.001|TWO_SIDED|95.0|25.1|44.2||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||44.2|25.1|<0.001
71729136|NCT02305849|142973360|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.0|55.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||55.0|36.0|<0.001
71729137|NCT02305849|142973362|SUPERIORITY||Percent Difference|20.3|||<|0.001|TWO_SIDED|95.0|12.5|28.1||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||28.1|12.5|<0.001
71661158|NCT00191113|142835885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.945||95.0|-0.199|0.186|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control|||0.186|-0.199|0.945
71729138|NCT02305849|142973362|SUPERIORITY||Percent Difference|31.5|||<|0.001|TWO_SIDED|95.0|23.1|40.0||No multiplicity adjustment.|Fisher Exact||C.I. was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||40.0|23.1|<0.001
71729139|NCT02305849|142973364|SUPERIORITY||LS Mean Difference|-1.597|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.948|-1.247||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: CRP Change = Treatment + Baseline CRP.||Treatment Difference vs Placebo||-1.247|-1.948|<0.001
71729140|NCT02305849|142973364|SUPERIORITY||LS Mean Difference|-1.458|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.852|-1.065||No multiplicity adjustment.|ANCOVA|||Treatment Difference vs Placebo||-1.065|-1.852|<0.001
71729141|NCT02305849|142973366|SUPERIORITY||LS Mean Difference|-17.89|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-21.61|-14.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-14.17|-21.61|<0.001
71661159|NCT00191113|142835887|SUPERIORITY_OR_OTHER|||||||||95.0||||P-value cannot be computed since no patients had abnormal result in either comparison group.|Fisher Exact|||||||
71729142|NCT02305849|142973366|SUPERIORITY||LS Mean Difference|-20.61|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|TWO_SIDED|95.0|-24.67|-16.56||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: ESR Change = Treatment + Baseline ESR.||Treatment Difference vs Placebo||-16.56|-24.67|<0.001
71729143|NCT02305849|142973368|SUPERIORITY||Percent Difference|33.0|||<|0.001|TWO_SIDED|95.0|23.7|42.2||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||42.2|23.7|<0.001
71729144|NCT02305849|142973368|SUPERIORITY||Percent Difference|45.5|||<|0.001|TWO_SIDED|95.0|36.2|54.8||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||54.8|36.2|<0.001
71729145|NCT02305849|142973370|SUPERIORITY||Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|32.3|52.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||52.5|32.3|<0.001
71729146|NCT02305849|142973370|SUPERIORITY||Percent Difference|49.3|||<|0.001|TWO_SIDED|95.0|39.7|58.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected|Treatment Difference vs Placebo||58.9|39.7|<0.001
71729147|NCT02305849|142973372|SUPERIORITY||Percent Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.1|27.3|||Fisher Exact|No multiplicity adjustment.|CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||27.3|12.1|<0.001
71729148|NCT02305849|142973372|SUPERIORITY||Percent Difference|30.4|||<|0.001|TWO_SIDED|95.0|22.0|38.7||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||38.7|22.0|<0.001
71729149|NCT02305849|142973374|SUPERIORITY||Percent Difference|42.5|||<|0.001|TWO_SIDED|95.0|32.3|52.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||52.6|32.3|<0.001
71888775|NCT00670007|143298657|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.371|||=|0.823|TWO_SIDED|95.0|-1.159|0.417||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.417|-1.159|= 0.823
71771458|NCT03569293|143042837|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.4|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.2|46.4|<0.001
71771459|NCT03569293|143042838|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|47.2|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||60.0|47.2|<0.001
71771460|NCT03569293|143042838|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|39.8|||<|0.001|TWO_SIDED|95.0|33.2|46.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||46.4|33.2|<0.001
71771461|NCT03569293|143042839|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.2|||<|0.001|TWO_SIDED|95.0|41.3|55.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.0|41.3|<0.001
71771462|NCT03569293|143042839|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.5|||<|0.001|TWO_SIDED|95.0|33.5|47.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||47.5|33.5|<0.001
71771463|NCT03569293|143042840|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.8|||<|0.001|TWO_SIDED|95.0|51.5|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||64.1|51.5|<0.001
71771464|NCT03569293|143042840|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|38.6|51.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.7|38.6|<0.001
71771465|NCT03569293|143042841|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|62.3|||<|0.001|TWO_SIDED|95.0|56.3|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||68.3|56.3|<0.001
71771466|NCT03569293|143042841|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|40.7|53.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.4|40.7|<0.001
71771467|NCT03569293|143042842|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.9|||<|0.001|TWO_SIDED|95.0|37.7|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.0|37.7|<0.001
71729150|NCT02305849|142973374|SUPERIORITY||Percent Difference|47.0|||<|0.001|TWO_SIDED|95.0|37.1|56.9||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||56.9|37.1|<0.001
71729151|NCT02305849|142973376|SUPERIORITY||Percent Difference|5.2||||0.011|TWO_SIDED|95.0|1.0|9.5||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||9.5|1.0|0.011
71729152|NCT02305849|142973376|SUPERIORITY||Percent Difference|9.3|||<|0.001|TWO_SIDED|95.0|4.1|14.6||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||14.6|4.1|<0.001
71729153|NCT02305849|142973378|SUPERIORITY|No multiplicity adjustment.|Percent Difference|6.4||||0.003|TWO_SIDED|95.0|1.8|11.0|||Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||11.0|1.8|0.003
71729154|NCT02305849|142973378|SUPERIORITY||Percent Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.5|19.4||No multiplicity adjustment.|Fisher Exact||CI was based on normal approximation to the binomial distribution (continuity corrected).|Treatment Difference vs Placebo||19.4|7.5|<0.001
71729155|NCT02305849|142973380|SUPERIORITY||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-13.84|-8.6||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-8.60|-13.84|<0.001
71729156|NCT02305849|142973380|SUPERIORITY||LS Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|-17.35|-11.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SDAI Change = Treatment + Baseline SDAI.||Treatment Difference vs Placebo||-11.98|-17.35|<0.001
71729157|NCT02305849|142973382|SUPERIORITY||LS Mean difference|-17.67|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-22.11|-13.22||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-13.22|-22.11|<0.001
71729158|NCT02305849|142973382|SUPERIORITY||LS Mean Difference|-24.09|STANDARD_ERROR_OF_MEAN|2.33|<|0.001||95.0|-28.66|-19.51||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS).||Treatment Difference vs Placebo||-19.51|-28.66|<0.001
71729159|NCT02305849|142973384|SUPERIORITY||LS Mean Difference|-16.64|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-21.09|-12.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS)||Treatment Difference vs Placebo||-12.19|-21.09|<0.001
71729160|NCT02305849|142973384|SUPERIORITY||LS Mean difference|-20.34|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-25.07|-15.61||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS).||Treatment Difference vs Placebo||-15.61|-25.07|<0.001
71831123|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.14||||0.478|TWO_SIDED|95.0|0.8|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=70% reduction||1.62|0.80|0.4780
71729161|NCT02305849|142973386|SUPERIORITY||LS Mean Difference|-17.19|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-22.0|-12.38||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-12.38|-22.00|<0.001
71729162|NCT02305849|142973386|SUPERIORITY||LS Mean difference|-20.89|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-25.8|-15.98||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SGAP (100 mm VAS) Change = Treatment + Baseline SGAP (100 mm VAS).||Treatment Difference vs Placebo||-15.98|-25.80|<0.001
71729163|NCT02305849|142973389|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.36|-0.17||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.17|-0.36|<0.001
71729164|NCT02305849|142973389|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.48|-0.29||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: HAQ-DI Change = Treatment + Baseline HAQ-DI.||Treatment Difference vs Placebo||-0.29|-0.48|<0.001
71729165|NCT02305849|142973391|SUPERIORITY||LS Mean Difference|6.41|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED|95.0|4.09|8.74||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||8.74|4.09|<0.001
71729166|NCT02305849|142973391|SUPERIORITY||LS Mean Difference|8.61|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|6.36|10.86||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||10.86|6.36|<0.001
71729167|NCT02305849|142973393|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|1.21|4.18||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||4.18|1.21|<0.001
71729168|NCT02305849|142973393|SUPERIORITY||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|0.78||0.036|TWO_SIDED|95.0|0.11|3.19||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||3.19|0.11|0.036
71729169|NCT02305849|142973395|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|1.39||0.099|TWO_SIDED|95.0|-0.44|5.02||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||5.02|-0.44|0.099
71831124|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4006|TWO_SIDED|95.0|0.7|2.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.42|0.70|0.4006
71831125|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3089|TWO_SIDED|95.0|0.74|2.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: \>=90% reduction||2.54|0.74|0.3089
71729170|NCT02305849|142973395|SUPERIORITY||LS Mean Difference|4.22|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|1.53|6.91||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: SF36-v2 Change = Treatment + Baseline SF36-v2.||Treatment Difference vs Placebo||6.91|1.53|0.002
71729171|NCT02305849|142973397|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|2.43||0.879|TWO_SIDED|95.0|-5.16|4.42||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||4.42|-5.16|0.879
71729172|NCT02305849|142973397|SUPERIORITY||LS Mean Difference|-1.81|STANDARD_ERROR_OF_MEAN|2.05||0.377|TWO_SIDED|95.0|-5.86|2.23||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||2.23|-5.86|0.377
71729173|NCT02305849|142973399|SUPERIORITY||LS Mean Difference|-9.63|STANDARD_ERROR_OF_MEAN|3.5||0.007|TWO_SIDED|95.0|-16.54|-2.73||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.73|-16.54|0.007
71729174|NCT02305849|142973399|SUPERIORITY||LS Mean Difference|-14.17|STANDARD_ERROR_OF_MEAN|3.58|<|0.001|TWO_SIDED|95.0|-21.24|-7.1||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.10|-21.24|<0.001
71771468|NCT03569293|143042842|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|28.6|40.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.5|28.6|<0.001
71771469|NCT03569293|143042843|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|19.2|||<|0.001|TWO_SIDED|95.0|14.6|23.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||23.9|14.6|<0.001
71831126|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0114|TWO_SIDED|95.0|1.05|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.50|1.05|0.0114
71831127|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.23||||0.0239|TWO_SIDED|95.0|1.03|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=30% reduction||1.47|1.03|0.0239
71831128|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0079|TWO_SIDED|95.0|1.07|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.07|0.0079
71888776|NCT00670007|143298657|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.176|||=|0.648|TWO_SIDED|95.0|-1.09|0.738||A 1-sided P-value \< 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being \> zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 \[CE1226\_4001\], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.||0.738|-1.09|= 0.648
71888777|NCT00670007|143298658|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.53||||0.526|TWO_SIDED|95.0|-2.179|1.12||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||1.120|-2.179|0.526
71729175|NCT02305849|142973401|SUPERIORITY||LS Mean Difference|-9.43|STANDARD_ERROR_OF_MEAN|3.63||0.01|TWO_SIDED|95.0|-16.6|-2.25||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-2.25|-16.60|0.010
71729176|NCT02305849|142973401|SUPERIORITY||LS Mean Difference|-14.61|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-21.92|-7.31||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-7.31|-21.92|<0.001
71729177|NCT02305849|142973403|SUPERIORITY||LS Mean Difference|-13.19|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.23|-8.16||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-8.16|-18.23|<0.001
71729178|NCT02305849|142973403|SUPERIORITY||LS Mean Difference|-17.61|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-22.57|-12.66||No multiplicity adjustment.|ANCOVA|Based on ANCOVA Model: WPAI Change = Treatment + Baseline WPAI.||Treatment Difference vs Placebo||-12.66|-22.57|<0.001
71729179|NCT02818036|142973435|OTHER|difference in neural activity to social task when taking naltrexone as compared to placebo|||||<|0.01||||||a priori threshold for significance was p\<.05|t-test, 1 sided|degrees of freedom = 75||||||<.01
71729180|NCT02818036|142973436|OTHER|differences in feelings of social connection between those who took naltrexone and those who took placebo||||||0.338||||||a priori threshold for statistical significance was p\<.05|t-test, 2 sided|||||||.338
71729181|NCT01038713|142973437|SUPERIORITY_OR_OTHER|||||||0.22||||||Analysis comparing the number of patients who had stent occlusion|Chi-squared|3 x 2 contingency table comparing all three groups||||||0.22
71729182|NCT01038713|142973437|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of attempted surgical resection||||0.14
71729183|NCT01038713|142973437|SUPERIORITY_OR_OTHER|||||||0.96|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of death between groups||||0.96
71729184|NCT01038713|142973438|SUPERIORITY_OR_OTHER|||||||1|||||||ANOVA|||||||1.00
71729185|NCT03777917|142973446|SUPERIORITY||Difference in Response Rates|72.1|||<|0.0001|TWO_SIDED|95.0|47.5|83.5|||Fisher Exact|The Fisher's exact test was used to test for the superiority of treatment (Belotero Balance®) over control.|Two-sided Newcombe confidence interval (CI) for the difference in response rates.|||83.5|47.5|< 0.0001
71729186|NCT00042432|142973452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.67||||0.006||95.0|1.6|20.06|||Cochran-Mantel-Haenszel|Adjusted for baseline glomenular filtration rate (GFR) strata|Logit estimates|||20.06|1.60|0.006
71729187|NCT00042432|142973453|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adusted for baseline glomerular filtration rate (GFR) strata||||||<0.001
71729188|NCT01853072|142973454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.5|3.0|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.||3.0|1.5|<0.001
71729189|NCT01853072|142973455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.1|0.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.||0.3|0.1|<0.001
71729190|NCT01527383|142973466|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
71888778|NCT00670007|143298658|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.486||||0.558|TWO_SIDED|95.0|-2.126|1.154||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.154|-2.126|0.558
71729191|NCT01527383|142973467|OTHER||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||<0.0001
71729192|NCT01287221|142973510|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.82
71729193|NCT01287221|142973511|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.62
71729194|NCT01287221|142973512|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.23
71729195|NCT01287221|142973513|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.31
71729196|NCT01287221|142973514|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.65
71729197|NCT01287221|142973515|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.61
71729198|NCT01287221|142973516|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.||||0.22
71729199|NCT00657150|142973517|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%|Risk Difference (Percentage)|-1.08|||<|0.0001||95.0|-3.79|1.64||Superiority p-value = 0.4367|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.64|-3.79|< 0.0001
71729200|NCT00657150|142973518|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.91||||0.029||95.0|-3.64|-0.19|||Normal approximation|Normal approximation of independent binomial distribution without stratification||||-0.19|-3.64|0.029
71729201|NCT00657150|142973519|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.79||||0.0358||95.0|-3.47|-0.12|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||-0.12|-3.47|0.0358
71729202|NCT00657150|142973520|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.96||||0.4839|TWO_SIDED|95.0|-3.65|1.73|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.73|-3.65|0.4839
71729203|NCT00657150|142973521|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0612
71729204|NCT00657150|142973522|SUPERIORITY_OR_OTHER|||||||0.6231||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6231
71729205|NCT00657150|142973523|SUPERIORITY_OR_OTHER|||||||0.4977||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4977
71729206|NCT00657150|142973524|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6870
71729207|NCT00657150|142973525|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||Fisher Exact|||Comparison versus Enoxaparin for the category major bleeding events||||0.4022
71729208|NCT00657150|142973525|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|0.8||||0.3305|TWO_SIDED|95.0|-0.8|2.3|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events||2.3|-0.8|0.3305
71729209|NCT00657150|142973525|SUPERIORITY_OR_OTHER||Absolute Difference (Percentage)|1.4||||0.2626|TWO_SIDED|95.0|-1.1|3.9|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category any bleeding events||3.9|-1.1|0.2626
71729210|NCT02649192|142973533|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season||||0.90
71729211|NCT02649192|142973533|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season||||0.49
71729212|NCT02649192|142973533|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season||||0.50
71729213|NCT02649192|142973533|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season||||0.90
71729214|NCT02649192|142973533|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season||||0.76
71729215|NCT02649192|142973533|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season||||0.65
71729216|NCT02649192|142973533|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season||||0.90
71771470|NCT03569293|143042843|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.6|||<|0.001|TWO_SIDED|95.0|10.3|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||18.8|10.3|<0.001
71888779|NCT00670007|143298658|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.019||||0.984|TWO_SIDED|95.0|-1.858|1.895||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||1.895|-1.858|0.984
71729217|NCT02649192|142973533|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season||||0.76
71729218|NCT02649192|142973533|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season||||0.54
71729219|NCT02649192|142973533|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season||||0.90
71729220|NCT02649192|142973533|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season||||0.95
71729221|NCT02649192|142973533|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season||||0.34
71729222|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|H1N1||0|0|
71729223|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-23.6|||||TWO_SIDED|95.0|-51.7|6.2|||||Treatment group minus placebo|H1N1||6.2|-51.7|
71729224|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-13.0|||||TWO_SIDED|95.0|-49.4|26.5|||||Treatment group minus placebo|H1N1||26.5|-49.4|
71729225|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-10.0|||||TWO_SIDED|95.0|-70.1|56.1|||||Treatment group minus placebo|H3N2||56.1|-70.1|
71729226|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-8.6|||||TWO_SIDED|95.0|-38.8|20.6|||||Treatment group minus placebo|H3N2||20.6|-38.8|
71729227|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|22.7|||||TWO_SIDED|95.0|-17.5|57.9|||||Treatment group minus placebo|H3N2||57.9|-17.5|
71729228|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Phuket||0|0|
71729229|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Phuket||5.8|-54.1|
71729230|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|16.9|||||TWO_SIDED|95.0|-23.1|53.3|||||Treatment group minus placebo|B/Phuket||53.3|-23.1|
71729231|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Treatment group minus placebo|B/Brisbane||0|0|
71729232|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-26.4|||||TWO_SIDED|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Brisbane||5.8|-54.1|
71729233|NCT02649192|142973534|SUPERIORITY||Treatment Difference in Seroconversion R|-8.4|||||TWO_SIDED|95.0|-45.4|30.5|||||Treatment group minus placebo|B/Brisbane||30.5|-45.4|
71729234|NCT00438854|142973539|SUPERIORITY_OR_OTHER||Estimating proportion of responders|0.2||||||||||||||The primary measures of efficacy of tumor response were: complete remission (CR), nodular partial remission (nPR), or partial remission (PR), as per NCI-WG criteria. The true ORR is reported as percentage and 90% CI calculated using the binomial exact test. Time to treatment failure (TTF) was defined from the date on study to date of progression, death in remission, initiation of non-protocol therapy in the absence of progression, or censored on the last visit.||||
71729235|NCT02193087|142973575|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.29|||||TWO_SIDED|90.0|0.23|0.36||||||DEN-1||0.36|0.23|
71729236|NCT02193087|142973575|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.06|||||TWO_SIDED|90.0|0.9|1.26||||||DEN-2||1.26|0.90|
71729237|NCT02193087|142973575|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.46|||||TWO_SIDED|90.0|1.13|1.89||||||DEN-3||1.89|1.13|
71729238|NCT02193087|142973575|NON_INFERIORITY_OR_EQUIVALENCE|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.74|||||TWO_SIDED|90.0|0.57|0.95||||||DEN-4||0.95|0.57|
71729239|NCT04030247|142973588|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
71729240|NCT04030247|142973589|OTHER|||||||0.16|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.16
71729241|NCT04030247|142973590|OTHER|||||||0.03|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.03
71729242|NCT04030247|142973591|OTHER|||||||0.9|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.9
71729243|NCT04030247|142973592|OTHER|||||||0.5|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.5
71771471|NCT03569293|143042844|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.1|||<|0.001|TWO_SIDED|95.0|3.8|12.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.5|3.8|<0.001
71888780|NCT00670007|143298659|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|0.294||||0.883|TWO_SIDED|95.0|-3.645|4.233||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.||4.233|-3.645|0.883
71888781|NCT00670007|143298659|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|-0.151||||0.941|TWO_SIDED|95.0|-4.172|3.87||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||3.870|-4.172|0.941
71888782|NCT00670007|143298659|SUPERIORITY_OR_OTHER||Difference in lung density(adjusted P15)|1.787||||0.404|TWO_SIDED|95.0|-2.44|6.014||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.||6.014|-2.440|0.404
71729244|NCT04030247|142973593|OTHER|||||||0.4|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.4
71729245|NCT04030247|142973595|OTHER|||||||0.6|||||||t-test, 2 sided|||Difference between baseline and month 3||||0.6
71729246|NCT01340937|142973678|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Concentration (GMC) ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.91|||||TWO_SIDED|95.0|0.77|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.77|
71729247|NCT01340937|142973678|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.86|||||TWO_SIDED|95.0|0.72|1.02|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.72|
71729248|NCT01340937|142973678|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.94|||||TWO_SIDED|95.0|0.79|1.12|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.12|0.79|
71729249|NCT01340937|142973678|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.63|||<|0.001|TWO_SIDED|95.0|1.35|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.35|<0.001
71729250|NCT01340937|142973679|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.48|||||TWO_SIDED|95.0|-4.31|3.35|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||3.35|-4.31|
71729251|NCT01340937|142973679|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.62|||||TWO_SIDED|95.0|-5.38|2.12|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.12|-5.38|
71729252|NCT01340937|142973679|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.16|||||TWO_SIDED|95.0|-4.89|2.58|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer \>=1 µg/mL||2.58|-4.89|
71729253|NCT01340937|142973679|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|7.93|||<|0.001|TWO_SIDED|95.0|3.38|13.17|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1 µg/mL||13.17|3.38|<0.001
71729254|NCT01340937|142973679|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|2.2|||<|0.001|TWO_SIDED|95.0|0.39|5.12|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 µg/mL||5.12|0.39|<0.001
71729255|NCT01340937|142973680|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.87|||||TWO_SIDED|95.0|0.76|0.98|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.98|0.76|
71771472|NCT03569293|143042845|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.0|||<|0.001|TWO_SIDED|95.0|8.1|17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.8|8.1|<0.001
71771473|NCT03569293|143042846|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-25.2|||<|0.001|TWO_SIDED|95.0|-30.3|-20.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-20.1|-30.3|<0.001
71771474|NCT03569293|143042846|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-29.3|-18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-18.9|-29.3|<0.001
71771475|NCT03569293|143042847|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.2|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|45.2|<0.001
71771476|NCT03569293|143042847|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|41.8|||<|0.001|TWO_SIDED|95.0|33.9|49.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||49.7|33.9|<0.001
71771477|NCT03569293|143042848|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.6|||<|0.001|TWO_SIDED|95.0|41.0|56.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.1|41.0|<0.001
71729256|NCT01340937|142973680|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.85|||||TWO_SIDED|95.0|0.74|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.74|
71771478|NCT03569293|143042848|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|30.9|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|30.9|<0.001
71771479|NCT03569293|143042849|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.9|||<|0.001|TWO_SIDED|95.0|45.4|60.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.3|45.4|<0.001
71771480|NCT03569293|143042849|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.3|||<|0.001|TWO_SIDED|95.0|30.4|46.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.2|30.4|<0.001
71888783|NCT00618722|143298669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.043|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.9|0.043
71888784|NCT00618722|143298669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.05|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.0|-0.8|0.050
71888785|NCT00618722|143298669|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||0.2|-0.7|0.249
71729257|NCT01340937|142973680|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.86|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.86|
71771481|NCT03569293|143042850|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|44.7|60.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.4|44.7|<0.001
71771482|NCT03569293|143042850|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|42.7|||<|0.001|TWO_SIDED|95.0|34.4|50.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.9|34.4|<0.001
71771483|NCT03569293|143042851|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|44.9|61.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.3|44.9|<0.001
71771484|NCT03569293|143042851|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|36.2|53.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.2|36.2|<0.001
71771485|NCT03569293|143042852|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|20.0|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||30.6|20.0|<0.001
71729258|NCT01340937|142973681|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.07|0.84|
71729259|NCT01340937|142973681|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.97|||||TWO_SIDED|95.0|0.86|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.86|
71729260|NCT01340937|142973681|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.9|1.14|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.14|0.90|
71771486|NCT03569293|143042852|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|15.0|||<|0.001|TWO_SIDED|95.0|10.4|19.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.6|10.4|<0.001
71771487|NCT03569293|143042853|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-45.98|STANDARD_ERROR_OF_MEAN|6.549|<|0.001|TWO_SIDED|95.0|-58.82|-33.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.15|-58.82|<0.001
71771488|NCT03569293|143042853|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-36.74|||<|0.001|TWO_SIDED|95.0|-49.66|-23.81|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-23.81|-49.66|<0.001
71729261|NCT01340937|142973682|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.91|1.04|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.04|0.91|
71729262|NCT01340937|142973682|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
71729263|NCT01340937|142973682|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.05|||||TWO_SIDED|95.0|0.98|1.13|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.13|0.98|
71729264|NCT01340937|142973683|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|1.03|||||TWO_SIDED|95.0|0.96|1.1|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.10|0.96|
71729265|NCT01340937|142973683|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||TWO_SIDED|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.95|
71729266|NCT01340937|142973683|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.06|0.92|
71729267|NCT01340937|142973683|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.2|||<|0.001|TWO_SIDED|95.0|1.11|1.29|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.29|1.11|<0.001
71729268|NCT01340937|142973684|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.89|||||TWO_SIDED|95.0|0.83|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.83|
71729269|NCT01340937|142973684|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.78|||||TWO_SIDED|95.0|0.72|0.83|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.83|0.72|
71729270|NCT01340937|142973684|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.87|||||TWO_SIDED|95.0|0.81|0.94|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.94|0.81|
71831129|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0068|TWO_SIDED|95.0|1.08|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=50% reduction||1.60|1.08|0.0068
71831130|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1037|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.62|0.96|0.1037
71831131|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0046|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.12|0.0046
71888786|NCT00618722|143298670|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.003|TWO_SIDED|95.0|0.7|3.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||3.1|0.7|0.003
71888787|NCT00618722|143298670|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.6|0.1|0.030
71888788|NCT00618722|143298670|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.012|TWO_SIDED|95.0|0.4|2.8|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||2.8|0.4|0.012
71729271|NCT01340937|142973684|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.67||||0.419|TWO_SIDED|95.0|0.62|0.73|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||0.73|0.62|0.419
71729272|NCT01340937|142973685|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
71831132|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1971|TWO_SIDED|95.0|0.85|2.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.19|0.85|0.1971
71729273|NCT01340937|142973685|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.93|||||TWO_SIDED|95.0|0.83|1.05|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.83|
71831133|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.59||||0.048|TWO_SIDED|95.0|1.0|2.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: \>=90% reduction||2.52|1.00|0.0480
71888789|NCT00618722|143298671|SUPERIORITY_OR_OTHER||Difference from Placebo|38.9||||0.015|TWO_SIDED|95.0|12.6|65.2|||Fisher Exact|||||65.2|12.6|0.015
71888790|NCT00618722|143298671|SUPERIORITY_OR_OTHER||Difference from Placebo|28.9||||0.096|TWO_SIDED|95.0|0.4|57.5|||Fisher Exact|||||57.5|0.4|0.096
71888791|NCT00618722|143298671|SUPERIORITY_OR_OTHER||Difference from Placebo|44.7||||0.003|TWO_SIDED|95.0|20.6|68.8|||Fisher Exact|||||68.8|20.6|0.003
71729274|NCT01340937|142973685|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.96|||||TWO_SIDED|95.0|0.85|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.08|0.85|
71729275|NCT01340937|142973685|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.17|0.90|<0.001
71729276|NCT01340937|142973686|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.78|||||TWO_SIDED|95.0|0.72|0.85|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.85|0.72|
71729277|NCT01340937|142973686|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.8|||||TWO_SIDED|95.0|0.73|0.87|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.87|0.73|
71729278|NCT01340937|142973686|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.11|0.93|
71729279|NCT01340937|142973686|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.51|||<|0.001|TWO_SIDED|95.0|1.37|1.66|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis||1.66|1.37|<0.001
71729280|NCT01340937|142973687|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Titer (GMT) ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.86|||||TWO_SIDED|95.0|0.76|0.96|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.96|0.76|
71729281|NCT01340937|142973687|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.88|||||TWO_SIDED|95.0|0.79|0.99|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||0.99|0.79|
71729282|NCT01340937|142973687|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.92|1.15|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.15|0.92|
71729283|NCT01340937|142973688|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.94|||||TWO_SIDED|95.0|0.84|1.05|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.05|0.84|
71729284|NCT01340937|142973688|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.91|||||TWO_SIDED|95.0|0.82|1.02|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.02|0.82|
71729285|NCT01340937|142973688|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|0.98|||||TWO_SIDED|95.0|0.87|1.09|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.09|0.87|
71729286|NCT01340937|142973689|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|1.06|||||TWO_SIDED|95.0|0.92|1.22|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.22|0.92|
71729287|NCT01340937|142973689|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.26|0.95|
71729288|NCT01340937|142973689|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||TWO_SIDED|95.0|0.9|1.19|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||1.19|0.90|
71888792|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.078|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.6|0.0|0.078
71888793|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.781|TWO_SIDED|95.0|-0.3|0.4|||Repeated easures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.3|0.781
71729289|NCT01340937|142973690|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.34|||||TWO_SIDED|95.0|-1.23|0.3|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.30|-1.23|
71729290|NCT01340937|142973690|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-0.34|||||TWO_SIDED|95.0|-1.23|0.32|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.32|-1.23|
71729291|NCT01340937|142973690|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.64|0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.66|-0.64|
71771489|NCT03569293|143042854|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-47.03|STANDARD_ERROR_OF_MEAN|2.716|<|0.001|TWO_SIDED|95.0|-52.37|-41.7|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-41.70|-52.37|<0.001
71771490|NCT03569293|143042854|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.738|<|0.001|TWO_SIDED|95.0|-44.91|-34.15|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.15|-44.91|<0.001
71771491|NCT03569293|143042855|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|58.6|||<|0.001|TWO_SIDED|95.0|51.9|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||65.3|51.9|<0.001
71771492|NCT03569293|143042855|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|52.3|||<|0.001|TWO_SIDED|95.0|45.2|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|45.2|<0.001
71771493|NCT03569293|143042856|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|45.9|60.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.5|45.9|<0.001
71771494|NCT03569293|143042856|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|39.0|54.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.4|39.0|<0.001
71831134|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4744|TWO_SIDED|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.28|0.89|0.4744
71831135|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0336|TWO_SIDED|95.0|1.02|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=30% reduction||1.45|1.02|0.0336
71831136|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.2||||0.0559|TWO_SIDED|95.0|1.0|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.44|1.00|0.0559
71831137|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0021|TWO_SIDED|95.0|1.11|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=50% reduction||1.61|1.11|0.0021
71831138|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0535|TWO_SIDED|95.0|1.0|1.59|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.59|1.00|0.0535
71831139|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0003|TWO_SIDED|95.0|1.22|1.92|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=70% reduction||1.92|1.22|0.0003
71888794|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.5|-0.1|0.146
71771495|NCT03569293|143042857|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.39|STANDARD_ERROR_OF_MEAN|2.732|<|0.001|TWO_SIDED|95.0|-45.75|-35.03|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-35.03|-45.75|<0.001
71771496|NCT03569293|143042857|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-33.03|STANDARD_ERROR_OF_MEAN|2.758|<|0.001|TWO_SIDED|95.0|-38.44|-27.61|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.61|-38.44|<0.001
71771497|NCT03569293|143042858|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|24.8|45.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.1|24.8|<0.001
71771498|NCT03569293|143042858|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|21.4|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||41.6|21.4|<0.001
71771499|NCT03569293|143042859|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|30.8|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|30.8|<0.001
71888795|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.076|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|0.0|0.076
71888796|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.3|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.3|0.975
71888797|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.183|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.1|0.183
71888798|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.017|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.017
71771500|NCT03569293|143042859|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|25.9|||<|0.001|TWO_SIDED|95.0|19.7|32.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||32.1|19.7|<0.001
71771501|NCT03569293|143042860|SUPERIORITY||Adjusted Response Rate Difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||79.4|53.8|<0.001
71771502|NCT03569293|143042860|SUPERIORITY||Adjusted Response Rate Difference|62.0|||<|0.001|TWO_SIDED|95.0|48.6|75.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.4|48.6|<0.001
71771503|NCT03569293|143042861|SUPERIORITY||Adjusted Response Rate Difference|57.4|||<|0.001|TWO_SIDED|95.0|44.6|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|44.6|<0.001
71771504|NCT03569293|143042861|SUPERIORITY||Adjusted Response Rate Difference|39.1|||<|0.001|TWO_SIDED|95.0|25.6|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|25.6|<0.001
71888799|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.022|TWO_SIDED|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.7|0.1|0.022
71771505|NCT03569293|143042862|SUPERIORITY||Adjusted Response Rate Difference|46.6|||<|0.001|TWO_SIDED|95.0|32.6|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.6|32.6|<0.001
71771506|NCT03569293|143042862|SUPERIORITY||Adjusted Response Rate Difference|38.7|||<|0.001|TWO_SIDED|95.0|24.3|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|24.3|<0.001
71771507|NCT03569293|143042863|SUPERIORITY||Adjusted Response Rate Difference|63.9|||<|0.001|TWO_SIDED|95.0|51.8|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||75.9|51.8|<0.001
71771508|NCT03569293|143042863|SUPERIORITY||Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|30.9|56.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.7|30.9|<0.001
71771509|NCT03569293|143042864|SUPERIORITY||Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|41.7|67.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.8|41.7|<0.001
71771510|NCT03569293|143042864|SUPERIORITY||Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|32.0|58.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||58.3|32.0|<0.001
71771511|NCT03569293|143042865|SUPERIORITY||Adjusted Response Rate Difference|47.1|||<|0.001|TWO_SIDED|95.0|34.0|60.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.2|34.0|<0.001
71771512|NCT03569293|143042865|SUPERIORITY||Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|23.2|48.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.6|23.2|<0.001
71771513|NCT03569293|143042866|SUPERIORITY||Adjusted Response Rate Difference|21.0|||<|0.001|TWO_SIDED|95.0|11.0|31.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.1|11.0|<0.001
71771514|NCT03569293|143042866|SUPERIORITY||Adjusted Response Rate Difference|9.4||||0.008|TWO_SIDED|95.0|2.5|16.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||16.4|2.5|0.008
71771515|NCT03569293|143042867|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.015|TWO_SIDED|95.0|2.1|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||19.9|2.1|0.015
71771516|NCT03569293|143042867|SUPERIORITY||Adjusted Response Rate Difference|6.5||||0.086|TWO_SIDED|95.0|-0.9|13.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||13.9|-0.9|0.086
71771517|NCT03569293|143042868|SUPERIORITY||Adjusted Response Rate Difference|10.8||||0.045|TWO_SIDED|95.0|0.2|21.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.4|0.2|0.045
71771518|NCT03569293|143042868|SUPERIORITY||Adjusted Response Rate Difference|11.0||||0.04|TWO_SIDED|95.0|0.5|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|0.5|0.040
71771519|NCT03569293|143042869|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.6|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.6|<0.001
71771520|NCT03569293|143042869|SUPERIORITY||Adjusted Response Rate Difference|-22.1|||<|0.001|TWO_SIDED|95.0|-32.7|-11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-11.5|-32.7|<0.001
71771521|NCT03569293|143042870|SUPERIORITY||Adjusted Response Rate Difference|53.6|||<|0.001|TWO_SIDED|95.0|37.7|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|37.7|<0.001
71771522|NCT03569293|143042870|SUPERIORITY||Adjusted Response Rate Difference|34.8|||<|0.001|TWO_SIDED|95.0|18.1|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||51.4|18.1|<0.001
71771523|NCT03569293|143042871|SUPERIORITY||Adjusted Response Rate Difference|56.6|||<|0.001|TWO_SIDED|95.0|42.0|71.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.1|42.0|<0.001
71771524|NCT03569293|143042871|SUPERIORITY||Adjusted Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|16.9|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.1|16.9|<0.001
71771525|NCT03569293|143042872|SUPERIORITY||Adjusted Response Rate Difference|50.9|||<|0.001|TWO_SIDED|95.0|35.1|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|35.1|<0.001
71771526|NCT03569293|143042872|SUPERIORITY||Adjusted Response Rate Difference|35.7|||<|0.001|TWO_SIDED|95.0|18.8|52.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||52.6|18.8|<0.001
71771527|NCT03569293|143042873|SUPERIORITY||Adjusted Response Rate Difference|54.4|||<|0.001|TWO_SIDED|95.0|37.4|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.3|37.4|<0.001
71771528|NCT03569293|143042873|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|19.8|56.4|||Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||56.4|19.8|<0.001
71888800|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.081|TWO_SIDED|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.6|0.0|0.081
71729292|NCT01340937|142973690|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.92|||<|0.001|TWO_SIDED|95.0|0.2|2.9|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.90|0.20|<0.001
71729293|NCT01340937|142973691|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|0.25|||||TWO_SIDED|95.0|-3.74|4.24|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.24|-3.74|
71729294|NCT01340937|142973691|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.35|||||TWO_SIDED|95.0|-5.26|2.57|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.57|-5.26|
71729295|NCT01340937|142973691|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.64|||||TWO_SIDED|95.0|-5.56|2.28|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.28|-5.56|
71729296|NCT01340937|142973691|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-2.35|||<|0.001|TWO_SIDED|95.0|-6.02|2.09|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.09|-6.02|<0.001
71729297|NCT01340937|142973692|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|-0.16|||||TWO_SIDED|95.0|-0.91|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.91|
71729298|NCT01340937|142973692|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|-0.16|||||TWO_SIDED|95.0|-0.9|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.47|-0.90|
71729299|NCT01340937|142973692|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.63|0.62|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.62|-0.63|
71729300|NCT01340937|142973692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|1.28|||<|0.001|TWO_SIDED|95.0|0.46|3.33|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.33|0.46|<0.001
71729301|NCT01340937|142973693|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|1.73|||||TWO_SIDED|95.0|0.37|3.4|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.40|0.37|
71729302|NCT01340937|142973693|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|0.36|||||TWO_SIDED|95.0|-0.77|1.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.63|-0.77|
71729303|NCT01340937|142973693|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.36|||||TWO_SIDED|95.0|-3.03|0.15|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.15|-3.03|
71729304|NCT01340937|142973693|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.72|||<|0.001|TWO_SIDED|95.0|-0.59|3.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.14|-0.59|<0.001
71729305|NCT01340937|142973694|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-1.35|||||TWO_SIDED|95.0|-5.17|2.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||2.47|-5.17|
71729306|NCT01340937|142973694|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-3.06|||||TWO_SIDED|95.0|-6.79|0.67|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.67|-6.79|
71729307|NCT01340937|142973694|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.71|||||TWO_SIDED|95.0|-5.37|1.94|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||1.94|-5.37|
71729308|NCT01340937|142973694|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-4.7|||<|0.001|TWO_SIDED|95.0|-7.73|-0.86|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.86|-7.73|<0.001
71729309|NCT01340937|142973695|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|2.77|||||TWO_SIDED|95.0|-1.83|7.39|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.39|-1.83|
71729310|NCT01340937|142973695|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|2.41|||||TWO_SIDED|95.0|-2.21|7.06|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||7.06|-2.21|
71729311|NCT01340937|142973695|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.36|||||TWO_SIDED|95.0|-5.14|4.42|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||4.42|-5.14|
71729312|NCT01340937|142973695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.28|||<|0.001|TWO_SIDED|95.0|-1.7|8.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.85|-1.70|<0.001
71729313|NCT01340937|142973696|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-4.12|||||TWO_SIDED|95.0|-7.69|-0.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.63|-7.69|
71729314|NCT01340937|142973696|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-4.17|||||TWO_SIDED|95.0|-7.75|-0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||-0.66|-7.75|
71729315|NCT01340937|142973696|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.07|||||TWO_SIDED|95.0|-3.32|3.2|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||3.20|-3.32|
71729316|NCT01340937|142973696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|2.85|||<|0.001|TWO_SIDED|95.0|-0.85|7.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.36|-0.85|<0.001
71729317|NCT01340937|142973697|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71729318|NCT01340937|142973697|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71729319|NCT01340937|142973697|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71729320|NCT01340937|142973697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.66|||<|0.001|TWO_SIDED|95.0|0.18|2.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.36|0.18|<0.001
71729321|NCT01340937|142973698|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71729322|NCT01340937|142973698|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
71771529|NCT03569293|143042874|SUPERIORITY||Adjusted Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|33.3|69.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.1|33.3|<0.001
71831140|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.11||||0.6421|TWO_SIDED|95.0|0.72|1.7|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||1.70|0.72|0.6421
71771530|NCT03569293|143042874|SUPERIORITY||Adjusted Response Rate Difference|28.1||||0.006|TWO_SIDED|95.0|8.0|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|8.0|0.006
71771531|NCT03569293|143042875|SUPERIORITY||Adjusted Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|19.9|42.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||42.5|19.9|<0.001
71771532|NCT03569293|143042875|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.001|TWO_SIDED|95.0|6.9|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||24.6|6.9|0.001
71729323|NCT01340937|142973698|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.60|-0.61|
71729324|NCT01340937|142973698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.0|||<|0.001|TWO_SIDED|95.0|-0.2|1.24|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.24|-0.20|<0.001
71729325|NCT01340937|142973699|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71729326|NCT01340937|142973699|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71831141|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0207|TWO_SIDED|95.0|1.07|2.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: \>=90% reduction||2.38|1.07|0.0207
71729327|NCT01340937|142973699|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||||TWO_SIDED|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|||0.61|-0.61|
71729328|NCT01340937|142973699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (Comb - Ctrl)|0.33|||<|0.001|TWO_SIDED|95.0|0.05|1.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.85|0.05|<0.001
71729329|NCT01340937|142973700|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.07|||<|0.001|TWO_SIDED|95.0|0.98|1.17|||Analysis of Covariance|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.17|0.98|<0.001
71729330|NCT01340937|142973701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.79|<0.001
71729331|NCT01340937|142973702|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.74||||0.035|TWO_SIDED|95.0|0.66|0.83|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.83|0.66|0.035
71771533|NCT03569293|143042876|SUPERIORITY||LS Mean Difference|-42.42|||<|0.001|TWO_SIDED|95.0|-56.16|-28.68|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-28.68|-56.16|<0.001
71771534|NCT03569293|143042876|SUPERIORITY||LS Mean Difference|-33.88|||<|0.001|TWO_SIDED|95.0|-47.76|-19.99|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-19.99|-47.76|<0.001
71771535|NCT03569293|143042877|SUPERIORITY||LS Mean Difference|-41.84|||<|0.001|TWO_SIDED|95.0|-52.09|-31.58|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-31.58|-52.09|<0.001
71771536|NCT03569293|143042877|SUPERIORITY||LS Mean Difference|-37.84|||<|0.001|TWO_SIDED|95.0|-48.17|-27.52|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-27.52|-48.17|<0.001
71771537|NCT03569293|143042878|SUPERIORITY||Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|40.3|69.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.4|40.3|<0.001
71771538|NCT03569293|143042878|SUPERIORITY||Adjusted Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|34.8|65.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||65.3|34.8|<0.001
71729332|NCT01340937|142973703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.31|||<|0.001|TWO_SIDED|95.0|1.17|1.46|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.46|1.17|<0.001
71729333|NCT01340937|142973704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|0.12|||<|0.001|TWO_SIDED|95.0|-1.11|2.58|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.58|-1.11|<0.001
71729334|NCT01340937|142973705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|-0.16|||<|0.001|TWO_SIDED|95.0|-2.41|3.22|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.22|-2.41|<0.001
71771539|NCT03569293|143042879|SUPERIORITY||Adjusted Response Rate Difference|45.1|||<|0.001|TWO_SIDED|95.0|21.0|69.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.2|21.0|<0.001
71771540|NCT03569293|143042879|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.7|72.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.5|26.7|<0.001
71771541|NCT03569293|143042880|SUPERIORITY||LS Mean Difference|-38.92|||<|0.001|TWO_SIDED|95.0|-49.54|-28.31|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-28.31|-49.54|<0.001
71771542|NCT03569293|143042880|SUPERIORITY||LS Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-43.44|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-21.96|-43.44|<0.001
71888801|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.51|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.2|0.510
71771543|NCT03569293|143042881|SUPERIORITY||Adjusted Response Rate Difference|51.7|||<|0.001|TWO_SIDED|95.0|31.7|71.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||71.8|31.7|<0.001
71771544|NCT03569293|143042881|SUPERIORITY||Adjusted Response Rate Difference|44.7|||<|0.001|TWO_SIDED|95.0|26.7|62.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.8|26.7|<0.001
71729335|NCT01340937|142973706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|1.15|||<|0.001|TWO_SIDED|95.0|-2.13|5.47|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||5.47|-2.13|<0.001
71729336|NCT01340937|142973707|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (Comb - Ctrl)|3.0|||<|0.001|TWO_SIDED|95.0|-0.39|7.4|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||7.40|-0.39|<0.001
71729337|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.92|||<|0.001|TWO_SIDED|95.0|0.82|1.04|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 1||1.04|0.82|<0.001
71888802|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.33|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.2|-0.5|0.330
71729338|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 3||1.06|0.84|<0.001
71729339|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.89|1.12|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 4||1.12|0.89|<0.001
71729340|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 5||1.07|0.80|<0.001
71729341|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.87|||<|0.001|TWO_SIDED|95.0|0.77|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6A||0.99|0.77|<0.001
71729342|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.79||||0.055|TWO_SIDED|95.0|0.64|0.96|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6B||0.96|0.64|0.055
71729343|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 7F||0.99|0.80|<0.001
71771545|NCT03569293|143042882|SUPERIORITY||Adjusted Response Rate Difference|25.1||||0.006|TWO_SIDED|95.0|7.3|43.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.0|7.3|0.006
71771546|NCT03569293|143042882|SUPERIORITY||Adjusted Response Rate Difference|15.8||||0.093|TWO_SIDED|95.0|-2.6|34.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||34.2|-2.6|0.093
71771547|NCT05803603|143042906|SUPERIORITY||Odds Ratio (OR)|2.0||||0.125|TWO_SIDED|95.0|0.37|10.92|||McNemar|||We recruited 8 homeless individuals and followed them for 12 months. 4 individuals (50%) were housed at 6 months and 3 (37.5) were housed at 12 months.|See results above|10.92|.37|.125
71771548|NCT05128929|143042907|SUPERIORITY||Mean Difference (Final Values)|0.614||||0.541|TWO_SIDED|95.0|-1.47|2.79|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||"Null: There is no significant difference in the mean primary endpoint (PVR) at 24 weeks between the treatment (H01) and placebo group.~The following analysis utilizes PVR determined by TD."||2.79|-1.47|0.541
71771549|NCT05128929|143042909|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.599|TWO_SIDED|95.0|-4.34|7.27|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (mPAP) at 24 weeks between the treatment (H01) and placebo group.||7.27|-4.34|0.599
71888803|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.3|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.3|0.720
71729344|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.88|1.13|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 9V||1.13|0.88|<0.001
71729345|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|TWO_SIDED|95.0|0.82|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 14||1.10|0.82|<0.001
71771550|NCT05128929|143042910|SUPERIORITY||Mean Difference (Final Values)|47.26||||0.166|TWO_SIDED|95.0|-21.43|115.95|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (6MWT distance) at 24 weeks between the treatment (H01) and placebo group.||115.95|-21.43|0.166
71729346|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|TWO_SIDED|95.0|0.79|1.0|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 18C||1.00|0.79|<0.001
71729347|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.91|||<|0.001|TWO_SIDED|95.0|0.8|1.03|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19A||1.03|0.80|<0.001
71729348|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.08|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19F||1.08|0.87|<0.001
71729349|NCT01340937|142973708|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (Combined/Control)|0.9|||<|0.001|TWO_SIDED|95.0|0.77|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 23F||1.06|0.77|<0.001
71729350|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||||TWO_SIDED|95.0|-18.8|-8.4|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \<38.0°C||-8.4|-18.8|
71729351|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-0.9|8.3|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38°C and \<38.5°||8.3|-0.9|
71729352|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|4.8|11.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=38.5°C and \<39.5°||11.9|4.8|
71729353|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.2|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes \>=39.5°C||2.2|-0.7|
71729354|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||||TWO_SIDED|95.0|-16.6|-5.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \<38.0°C||-5.9|-16.6|
71729355|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.4|7.8|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal \>=38.0°C and \<38.5°C||7.8|-1.4|
71729356|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||||TWO_SIDED|95.0|4.6|11.6|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=38.5°C and \<39.5°C||11.6|4.6|
71729357|NCT01340937|142973710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.7|2.1|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal \>=39.5°C||2.1|-0.7|
71729358|NCT00623545|142973730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|185.0|STANDARD_DEVIATION|240.0||0.001|TWO_SIDED|95.0||||The a prior threshold for statistical significance was p\< 0.05|ANOVA||units are kcal/d|Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg-1 divided by 84 days or 185 kcal·day-1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day-1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.||||0.001
71729359|NCT00623545|142973730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71888804|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.205|TWO_SIDED|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.1|0.205
71888805|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.41|TWO_SIDED|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.2|-0.5|0.410
71729360|NCT00623545|142973731|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.||||< 0.05
71729361|NCT00623545|142973731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71729362|NCT01974752|142973743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.3195|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Factor for treatment and liver metastases|A hazard ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.27|0.48|0.3195
71729363|NCT01974752|142973745|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.94||||0.1284|TWO_SIDED|95.0|0.88|1.02|||ANCOVA|ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.|A geometric least squares mean ratio \< 1 favours Selumetinib in combination with Dacarbazine|||1.02|0.88|0.1284
71729364|NCT01974752|142973746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.4011|TWO_SIDED|95.0|0.39|1.46|||Log Rank|||||1.46|0.39|0.4011
71729365|NCT01035346|142973747|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|8.33||||0.228|TWO_SIDED|95.0|-7.94|24.6||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.||24.60|-7.94|0.228
71771551|NCT05128929|143042911|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.975|TWO_SIDED|95.0|-8.22|7.98|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (emPHasis-10 score) at 24 weeks between the treatment (H01) and placebo group.||7.98|-8.22|0.975
71771552|NCT05128929|143042912|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.086|TWO_SIDED|95.0|-19.4|1.4|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (SGRQ Score) at 24 weeks between the treatment (H01) and placebo group.||1.4|-19.40|0.086
71771553|NCT05128929|143042913|SUPERIORITY||Mean Difference (Final Values)|73.92||||0.215|TWO_SIDED|95.0|-45.61|193.46|||Mixed Models Analysis|Analysis was adjusted for the randomization stratum of PAH Group.||Null: There is no significant difference in the mean secondary endpoint (serum HA) at 24 weeks between the treatment (H01) and placebo group.||193.46|-45.61|0.215
71729366|NCT01035346|142973748|SUPERIORITY_OR_OTHER||LS mean difference|5.99||||0.171|TWO_SIDED|95.0|-3.99|15.97||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||15.97|-3.99|0.171
71729367|NCT01035346|142973748|SUPERIORITY_OR_OTHER||LS mean difference|8.96||||0.354|TWO_SIDED|95.0|-14.78|32.69||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||32.69|-14.78|0.354
71771554|NCT05128929|143042914|SUPERIORITY||Mean Difference (Final Values)|231.47||||0.442|TWO_SIDED|95.0|-377.26|840.2|||Mixed Models Analysis|||There is no significant difference in the mean secondary endpoint (NT-proBNP) at 24 weeks between the treatment (H01) and placebo group.||840.20|-377.26|0.442
71771555|NCT02742246|143042924|SUPERIORITY|||||||0.11||||||Group by Time interaction.|Regression, Linear|||||||0.11
71771556|NCT02742246|143042925|SUPERIORITY|||||||0.14||||||Group by time interaction.|Regression, Linear|||||||0.14
71771557|NCT03553836|143042926|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.00046|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).|Log Rank||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).|||0.82|0.45|0.00046
71771558|NCT03553836|143042929|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.0|7.3||||||||7.3|1.0|
71771559|NCT03553836|143042930|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|12.9|||||TWO_SIDED|95.0|9.1|16.9||||||||16.9|9.1|
71771560|NCT02313454|143042959|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.8||0.008|TWO_SIDED|95.0|-1.0|-0.19|||Paired t-test||Intranasal Application relative to the Extranasal Application|||-0.19|-1.0|0.008
71771561|NCT02313454|143042960|SUPERIORITY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|15.7||0.004|TWO_SIDED|95.0|-19.0|-3.4|||Paired t-test||Intranasal application relative to Extranasal application|||-3.4|-19.0|0.004
71771562|NCT03170232|143043002|OTHER||Mean Difference (Final Values)|-67.2|STANDARD_ERROR_OF_MEAN|159.7||0.679|TWO_SIDED|95.0|-400.6|266.2|||Repeated measures random coefficient|||||266.2|-400.6|0.679
71771563|NCT01101191|143043039|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|103.0|||||TWO_SIDED|90.0|98.67|106.66|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||106.66|98.67|
71771564|NCT01101191|143043040|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.0|||||TWO_SIDED|90.0|94.2|99.81|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.81|94.20|
71771565|NCT01101191|143043041|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.1|||||TWO_SIDED|90.0|94.41|99.94|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||99.94|94.41|
71771566|NCT00718237|143043045|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|80.2|||<|0.001|TWO_SIDED|95.0|47.4|94.1||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||94.1|47.4|<0.001
71771567|NCT00718237|143043046|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|74.5|||<|0.001|TWO_SIDED|95.0|39.9|90.6||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||90.6|39.9|<0.001
71831142|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1635|TWO_SIDED|95.0|0.95|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.39|0.95|0.1635
71831143|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0529|TWO_SIDED|95.0|1.0|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=30% reduction||1.47|1.00|0.0529
71729368|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.576|TWO_SIDED|95.0|-0.84|0.54||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.54|-0.84|0.576
71729369|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.502|TWO_SIDED|95.0|-0.5|0.87||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.87|-0.50|0.502
71729370|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|1.31||||0.116|TWO_SIDED|95.0|-0.51|3.12||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.12|-0.51|0.116
71729371|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.161|TWO_SIDED|95.0|-0.98|4.14||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.14|-0.98|0.161
71729372|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|1.87||||0.215|TWO_SIDED|95.0|-1.66|5.41||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.41|-1.66|0.215
71729373|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|1.17||||0.388|TWO_SIDED|95.0|-2.18|4.52||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.52|-2.18|0.388
71729374|NCT01035346|142973749|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.849|TWO_SIDED|95.0|-3.98|4.61||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.61|-3.98|0.849
71729375|NCT01035346|142973751|SUPERIORITY_OR_OTHER||difference in proportion|11.11||||0.378|TWO_SIDED|95.0|-10.67|32.89||p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.||32.89|-10.67|0.378
71729376|NCT01035346|142973752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.324|TWO_SIDED|95.0|-0.3|1.27||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.27|-0.30|0.324
71729377|NCT01035346|142973753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.21|TWO_SIDED|95.0|-0.12|1.18||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||1.18|-0.12|0.210
71729378|NCT05074888|142973774|SUPERIORITY|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.0016
71729379|NCT05074888|142973775|SUPERIORITY|||||||0.3183|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.3183
71729380|NCT05074888|142973776|SUPERIORITY|||||||0.5805|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.5805
71729381|NCT05074888|142973777|SUPERIORITY|||||||0.2143|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and 4 weeks later row.||||0.2143
71729382|NCT05074888|142973778|SUPERIORITY|||||||0.8156|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.8156
71729383|NCT05074888|142973779|SUPERIORITY|||||||0.1049|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.1049
71729384|NCT05074888|142973780|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.7260
71771568|NCT00718237|143043047|SUPERIORITY_OR_OTHER||Vaccine Efficacy (1-Relative Risk [RR])|100.0|||<|0.001|TWO_SIDED|95.0|55.4|100.0||Hypothesis: Efficacy \>0%. Based on p\< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.|||100.0|55.4|<0.001
71729385|NCT05074888|142973781|SUPERIORITY|||||||0.6808|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between value after 4 weeks and after 8 weeks row.||||0.6808
71729386|NCT05074888|142973782|SUPERIORITY|||||||0.54||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.54
71729387|NCT05074888|142973783|SUPERIORITY|||||||0.49||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.49
71729388|NCT05074888|142973784|SUPERIORITY|||||||0.87||||||"The p-value associated with treatment\*visit interaction of systolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to SBP/Visit1, SBP/Visit2 and SBP/Visit3 rows.||||0.87
71729389|NCT05074888|142973784|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of diastolic blood pressure from Visit 1 to 3 between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||This analysis applies to DBP/Visit1, DBP/Visit2 and DBP/Visit3 rows.||||0.22
71729390|NCT05074888|142973785|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71729391|NCT05074888|142973786|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71729392|NCT05074888|142973787|SUPERIORITY|||||||0.17|||||||Fisher Exact|||||||0.17
71729393|NCT05074888|142973788|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71729394|NCT03541187|142973798|SUPERIORITY|The comparison between arms will be conducted using an analysis of covariance (ANCOVA) model, in which the change from the baseline to the 12-month TNSS mean serves as the outcome. The ANCOVA model will incorporate factors for treatment while adjusting for both the baseline TNSS mean and site.|Least Square Mean Difference|-0.23||||0.63|TWO_SIDED|95.0|-1.15|0.7|||ANCOVA|||||0.70|-1.15|0.63
71771569|NCT02925793|143043055|SUPERIORITY||Mean Difference|-2.9||||0.0106|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1% and 5% groups (statistical analysis 2) produced the same estimated value (-2.9)||||0.0106
71771570|NCT02925793|143043055|SUPERIORITY||Mean Difference|-2.9||||0.0483|TWO_SIDED||||||SAS Proc Mixed||For each subject, change in NRS score from baseline to week 8 was calculated as Week 8 NRS value minus Baseline NRS value. Mean change in NRS score from baseline to week 8 for each group was then calculated using a Generalized Linear Mixed Model.|Both 1%(statistical analysis 1) and 5% groups produced the same estimated value (-2.9)||||0.0483
71771571|NCT00829985|143043104|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.92|||<|0.0001|TWO_SIDED|95.0|1.51|2.45|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 1.12) vs. the extract group (numerator = 2.16).|||2.45|1.51|<0.0001
71771572|NCT00829985|143043105|SUPERIORITY_OR_OTHER||Risk Ratio, log|1.13||||0.088|TWO_SIDED|95.0|0.98|1.32|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 0.93) vs. the extract group (numerator = 1.06).|||1.32|0.98|0.088
71771573|NCT00829985|143043106|SUPERIORITY_OR_OTHER||Treatment Effect|0.37||||0.37|TWO_SIDED|95.0|-4.89|12.99|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.7) minus change in the placebo group (0.7).|||12.99|-4.89|0.37
71771574|NCT00829985|143043107|SUPERIORITY_OR_OTHER||Treatment Effect|5.4||||0.09|TWO_SIDED|95.0|-0.77|11.51|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.0) minus change in the placebo group (-1.3).|||11.51|-0.77|0.09
71771575|NCT03324581|143043115|SUPERIORITY||Difference|0.81|||=|0.7554|TWO_SIDED|95.0|-4.3|5.92||The change from baseline in CAARS-O:SV was analyzed using a Mixed-effect Model Repeated Measures (MMRM) methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||5.92|-4.30|=0.7554
71888806|NCT00618722|143298672|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.436|TWO_SIDED|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.2|0.436
71888807|NCT00618722|143298673|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.762|TWO_SIDED|95.0|-9.1|12.3|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||12.3|-9.1|0.762
71729395|NCT03541187|142973800|SUPERIORITY||Least Square Means Difference|-0.17||||0.69|TWO_SIDED|95.0|-0.99|0.66|||ANCOVA|||||0.66|-0.99|0.69
71771576|NCT03324581|143043115|SUPERIORITY||Difference|-6.61|||=|0.0101|TWO_SIDED|95.0|-11.6|-1.6||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-1.60|-11.6|=0.0101
71771577|NCT03324581|143043115|SUPERIORITY||Difference|-7.42|||=|0.0033|TWO_SIDED|95.0|-12.3|-2.5||The change from baseline in CAARS-O:SV was analyzed using a MMRM methodology with the unstructured variance covariance matrix.|Mixed-effect Model Repeated Measures|It included fixed class-effect terms: treatment,trial site,visit week, interaction term: treatment by visit week, Baseline CAARS-O:SV as a covariate.||||-2.50|-12.3|=0.0033
71771578|NCT05080660|143043177|SUPERIORITY||Posterior Mean Difference|0.23|||||TWO_SIDED|95.0|-0.26|0.73|||||Posterior mean difference with 95% credible interval is reported.|||0.73|-0.26|
71729396|NCT03541187|142973801|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.51|TWO_SIDED|95.0|0.42|1.54|||Regression, Cox||At the reactive dose of 15.4 mcg/mL after 12 months, there were 11 participants who were right-censored in the Cockroach SCIT arm and 8 participants who were right-censored in the Placebo arm.|||1.54|0.42|.51
71729397|NCT03541187|142973802|SUPERIORITY||Least Square Means Difference|-0.03||||0.91|TWO_SIDED|95.0|-0.54|0.49|||ANCOVA|||||0.49|-0.54|0.91
71729398|NCT03541187|142973803|SUPERIORITY||Least Square Means Difference|5.32|||<|0.001|TWO_SIDED|95.0|4.77|5.87|||ANCOVA|||||5.87|4.77|<0.001
71729399|NCT03060512|142973846|OTHER|||||||0.9239|||||||Prescott's test|||Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.||||0.9239
71729400|NCT03060512|142973846|OTHER|||||||0.8874|||||||Prescott's test|||Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preference||||0.8874
71771579|NCT05080660|143043178|SUPERIORITY||Posterior Mean Difference|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||Posterior mean difference with 95% credible interval is reported.|||0.76|-0.39|
71771580|NCT05080660|143043179|SUPERIORITY||Posterior Mean Difference|0.62|||||TWO_SIDED|95.0|-0.23|1.47|||||Posterior mean difference with 95% credible interval is reported.|||1.47|-0.23|
71888808|NCT00618722|143298673|SUPERIORITY_OR_OTHER||LS mean Difference|5.2||||0.248|TWO_SIDED|95.0|-3.8|14.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||14.2|-3.8|0.248
71729401|NCT03060512|142973849|OTHER||Least Squares (LS) Means difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.3|0.3||||||Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.||0.3|-0.3|
71771581|NCT05080660|143043180|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-0.67|1.34|||||Posterior mean difference with 95% credible interval is reported.|||1.34|-0.67|
71729402|NCT03060512|142973851|OTHER||LS Means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-4.7|3.0||||||Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.||3.0|-4.7|
71661160|NCT03786718|142835926|OTHER||||||<|0.001|||||||One sample median test|||Due to nonnormality, we used nonparametric tests to analyze the data. This analysis is a one sample median test of participants' median SUS score compared to the threshold score of 68 indicative of 'above average' usability.||||<0.001
71729403|NCT00904618|142973857|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||Fisher Exact|||The test applies to the number of participants improved.||||0.0087
71729404|NCT03220581|142973860|SUPERIORITY||F|9.026||||0.004|TWO_SIDED||||||ANCOVA|Baseline number of days of game play in the past week was included as a covariate.||||||.004
71771582|NCT05080660|143043181|SUPERIORITY||Posterior Mean Difference|0.08|||||TWO_SIDED|95.0|-0.35|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.35|
71771583|NCT05080660|143043182|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.35|0.55|||||Posterior mean difference with 95% credible interval is reported.|||0.55|-0.35|
71771584|NCT05080660|143043183|SUPERIORITY||Posterior Mean Difference|1.98|||||TWO_SIDED|95.0|-0.88|4.88|||||Posterior mean difference with 95% credible interval is reported.|||4.88|-0.88|
71771585|NCT05080660|143043184|SUPERIORITY||Posterior Mean Difference|3.05|||||TWO_SIDED|95.0|-0.29|6.38|||||Posterior mean difference with 95% credible interval is reported.|||6.38|-0.29|
71771586|NCT05080660|143043185|SUPERIORITY||Posterior Mean Difference|0.13|||||TWO_SIDED|95.0|-0.23|0.5|||||Posterior mean difference with 95% credible interval is reported.|||0.50|-0.23|
71771587|NCT05080660|143043186|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.39|0.37|||||Posterior mean difference with 95% credible interval is reported.|||0.37|-0.39|
71888809|NCT00618722|143298673|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3||||0.061|TWO_SIDED|95.0|-0.4|19.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.||||19.1|-0.4|0.061
71771588|NCT05080660|143043187|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.21|0.81|||||Posterior mean difference with 95% credible interval is reported.|||0.81|-0.21|
71888810|NCT00624221|143298675|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.||||||0.1|TWO_SIDED|95.0|||||paired difference t-test|||||||0.10
71888811|NCT00200057|143298678|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
71661161|NCT03786718|142835930|OTHER|||||||0.77|||||||Wilcoxon Signed Rank Sum test|||||||0.77
71729405|NCT03220581|142973861|SUPERIORITY||F|7.922||||0.007|TWO_SIDED||||||ANCOVA|Covariate = number of days of gaming in the past week at baseline, reported by the parent.||||||.007
71729406|NCT03220581|142973862|SUPERIORITY||F|3.73||||0.059|TWO_SIDED||||||ANCOVA|Controlled for number of symptoms of Internet gaming disorder at baseline - assessed through clinical interview with child||||||.059
71729407|NCT03220581|142973863|SUPERIORITY||F|2.91||||0.095|TWO_SIDED||||||ANCOVA|Controlled for baseline number of symptoms of Internet gaming disorder, assessed through clinical interview with the parent||||||.095
71729408|NCT02825966|142973884|EQUIVALENCE|The two one-sided t-test (TOST) was used to test equivalence. Using TOST, equivalence was established at α = 0.05 significance level if a (1-2α)\*100% confidence interval for the average difference in EMAT (WCD-AUDICOR) was contained within the interval \[-12, 12\].|Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|90.0|-2.89|4.69|||two one-sided test (TOST)|||First, the difference in EMAT between the LifeVest and AUDICOR device (first wear) was calculated for each subject. Then the mean and standard deviation of the differences in EMAT were calculated. The 2 devices were considered equivalent if the 90% confidence interval for mean difference in EMAT was within the pre-specified margin of \[-12, 12\] ms.||4.69|-2.89|< 0.001
71771589|NCT05080660|143043188|SUPERIORITY||Posterior Mean Difference|0.29|||||TWO_SIDED|95.0|-0.31|0.9|||||Posterior mean difference with 95% credible interval is reported.|||0.90|-0.31|
71771590|NCT05080660|143043189|SUPERIORITY||Posterior Mean Difference|6.14|||||TWO_SIDED|95.0|-0.24|12.52|||||Posterior mean difference with 95% credible interval is reported.|||12.52|-0.24|
71771591|NCT05080660|143043190|SUPERIORITY||Posterior Mean Difference|5.15|||||TWO_SIDED|95.0|-1.9|12.18|||||Posterior mean difference with 95% credible interval is reported.|||12.18|-1.90|
71771592|NCT05080660|143043191|SUPERIORITY||Posterior Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.32|0.27|||||Posterior mean difference with 95% credible interval is reported.|||0.27|-0.32|
71771593|NCT05080660|143043192|SUPERIORITY||Posterior Mean Difference|-0.2|||||TWO_SIDED|95.0|-0.52|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.52|
71771594|NCT05080660|143043193|SUPERIORITY||Posterior Mean Difference|98.35|||||TWO_SIDED|95.0|-51.95|250.88|||||Posterior mean difference with 95% credible interval is reported.|||250.88|-51.95|
71771595|NCT05080660|143043194|SUPERIORITY||Posterior Mean Difference|123.36|||||TWO_SIDED|95.0|-46.51|293.69|||||Posterior mean difference with 95% credible interval is reported.|||293.69|-46.51|
71771596|NCT05080660|143043195|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.06|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.06|
71771597|NCT05080660|143043196|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.07|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.07|
71771598|NCT04533685|143043197|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received reminder letters to the arm receiving no reminder letter (control)|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
71729409|NCT00681564|142973951|SUPERIORITY_OR_OTHER|||||||0.98||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics.||||0.98
71729410|NCT00681564|142973951|SUPERIORITY_OR_OTHER|||||||0.005||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours).||||0.005
71729411|NCT00681564|142973951|SUPERIORITY_OR_OTHER|||||||0.43||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||"Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures.~Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org."||||0.43
71729412|NCT00432744|142973986|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.015|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED|95.0|-0.44|0.48||Two-sided Test|Wilcoxon (Mann-Whitney)||Positive value of Tau-B would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.48|-0.44|0.95
71729413|NCT00432744|142973987|SUPERIORITY_OR_OTHER||Kendall's Tau B|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.18|TWO_SIDED|95.0|-0.12|0.72|||Wilcoxon (Mann-Whitney)||A positive value would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.||0.72|-0.12|0.18
71729414|NCT00432744|142973988|SUPERIORITY_OR_OTHER|||||||0.42||||||The Hotelling T-sq=1.74 and 42% of the rerandomizations to groups of 7 and 8 had Hotelling T-sq of at least 1.74. This is the standard method for permutation tests. The large sample null is chi-sq with 2 df, which has a mean=2.|Non-parametric Hotelling T-square|||The actual study was powered to have 40 participants but only 24 participated and of these only 15 had outcome data.||||0.42
71729415|NCT03849690|142973989|OTHER|Analysis of variance (ANOVA) performed on natural log(ln)-transformed TAK-906 Cmax which exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as random effect. Each ANOVA included calculation of least-squares means(LSM) and difference between treatment LSM. Geometric mean ratios and 90% confidence interval (CI) were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.87||||0.3011|TWO_SIDED|90.0|0.7|1.09|||ANOVA|||||1.09|0.70|0.3011
71729416|NCT03849690|142973990|OTHER|ANOVA was performed on ln-transformed TAK-906 AUClast which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90 percent (%) CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.0865|TWO_SIDED|90.0|0.77|0.99|||ANOVA|||||0.99|0.77|0.0865
71729417|NCT03849690|142973991|OTHER|ANOVA was performed on ln-transformed TAK-906 AUC∞ which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90% CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.3011|TWO_SIDED|90.0|0.78|1.0|||ANOVA|||||1.00|0.78|0.3011
71729418|NCT00892606|142973997|SUPERIORITY|||||||0.0072|||||||ANOVA|||||||0.0072
71729419|NCT00892606|142973998|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
71729420|NCT00892606|142973999|SUPERIORITY|||||||0.0146|||||||ANOVA|||||||0.0146
71729421|NCT00468845|142974000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.1378
71729422|NCT00468845|142974000|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471||95.0||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA|||||||0.4710
71729423|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.7752
71729424|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.3375
71729425|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7029||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.7029
71729426|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8618||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.8618
71729427|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2117||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2117
71729428|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6255
71729429|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0942
71729430|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9907||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.9907
71729431|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4678||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4678
71729432|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5500
71729433|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9333||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.9333
71888812|NCT00200057|143298679|SUPERIORITY_OR_OTHER||Proportion|0.73|||<|0.0001|TWO_SIDED|95.0|0.64|0.81||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.81|0.64|<0.0001
71888813|NCT00200057|143298680|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
71888814|NCT00200057|143298681|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
71729434|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7396||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7396
71729435|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2932||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.2932
71729436|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0164||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0164
71729437|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2468||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.2468
71729438|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7022
71729439|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7257||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7257
71729440|NCT00468845|142974001|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3854||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3854
71729441|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5997
71729442|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8582||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8582
71888815|NCT00200057|143298682|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
71729443|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3704||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.3704
71729444|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9747||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.9747
71729445|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2033
71729446|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2752
71729447|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.0183
71729448|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6906||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.6906
71729449|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5446||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.5446
71729450|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4852||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.4852
71729451|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5879||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.5879
71729452|NCT00468845|142974002|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7699||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS||||0.7699
71729453|NCT00468845|142974003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9676||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.9676
71729454|NCT00468845|142974003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4944||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4944
71729455|NCT00468845|142974004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4801||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4801
71729456|NCT00468845|142974004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8832||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.8832
71729457|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2125||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hours PS||||0.2125
71729458|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hour PS||||0.7602
71729459|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4053||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4053
71888816|NCT00200057|143298683|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test|||||||<0.0001
71729460|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4147||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS||||0.4147
71729461|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5556||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.5556
71729462|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.482||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.4820
71729463|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.5088
71771599|NCT04533685|143043197|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare arms which received direct appointment scheduling to the arms not receiving direct appointment scheduling.|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
71888817|NCT00200057|143298684|SUPERIORITY_OR_OTHER||Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.79||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.||0.79|0.62|<0.0001
71729464|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS||||0.3900
71729465|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9659||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.9659
71729466|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS||||0.3968
71729467|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8308||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.8308
71729468|NCT00468845|142974005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0902||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.0902
71729469|NCT00468845|142974006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4388||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.4388
71729470|NCT00468845|142974006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||||||0.3364
71729471|NCT00468845|142974007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2409||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.2409
71771600|NCT04533685|143043197|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|1.0|1.01|||||These results compare arms which received pre-commitment reminders to the arms not receiving pre-commitment reminders.|Comparing the risk of receiving an influenza vaccination||1.01|1.00|
71729472|NCT00468845|142974007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1654||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.1654
71729473|NCT00468845|142974007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1110
71729474|NCT00468845|142974007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0598||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0598
71771601|NCT04533685|143043197|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare arms which received pre-appointment reminder to the arms not receiving pre-appointment reminder.|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
71729475|NCT00468845|142974007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0398||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0398
71729476|NCT00468845|142974007|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0623||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.0623
71729477|NCT00468845|142974008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.2730
71729478|NCT00468845|142974008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS||||0.1015
71729479|NCT00468845|142974008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2438||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.2438
71729480|NCT00468845|142974008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS||||0.0102
71729481|NCT00468845|142974008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2063||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.2063
71729482|NCT00468845|142974008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS||||0.0387
71729483|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5995||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5995
71729484|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS||||0.9104
71729485|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS||||0.2177
71771602|NCT04221230|143043198|OTHER||Least square mean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.08||0.121|TWO_SIDED|95.0|-3.8|0.4|||Mixed Model Repeated Measures|||||0.4|-3.8|0.121
71771603|NCT03687970|143043217|OTHER|Multivariable logistic regression was applied to predict binary outcome while controlling for other potential confounding factors (age, cumulative chemotherapy dose, chemotherapy group).|Slope|-0.13||||0.05|TWO_SIDED|||||threshold for p value is 0.05.|Regression, Logistic|||||||0.05
71729486|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.1770
71729487|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1229||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1229
71729488|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1274||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.1274
71729489|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0568||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0568
71729490|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.0354
71729491|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4269||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.4269
71771604|NCT03687970|143043218|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.22||||0.7525|TWO_SIDED|||||The thrshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.7525
71771605|NCT03687970|143043218|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for Control group patients without painful CIPN was calculated.|rho coefficient|0.32||||0.1876|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficien|||||||0.1876
71771606|NCT03687970|143043218|OTHER|Spearman correlation coefficient between the Aδ:C fiber pain threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|0.13||||0.61|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.61
71771607|NCT03687970|143043218|OTHER|Spearman correlation coefficient between the Aδ:C fiber detection threshold ratio and the severity of painful CIPN on NPSI scale for patients with painful CIPN was calculated.|rho coefficient|-0.2812205||||0.2914|TWO_SIDED|||||The threshold for p value is 0.05.|Spearman's correlation coefficient|||||||0.2914
71888818|NCT05197803|143298695|SUPERIORITY||Mean Difference (Final Values)|3.32||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (BTE)||||0.0001
71888819|NCT05197803|143298695|SUPERIORITY||Mean Difference (Final Values)|3.57||||0.0001|ONE_SIDED||||||t-test, 1 sided|||The study compared the results between the unaided condition vs. aided condition (RIC)||||0.0001
71729492|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2058
71888820|NCT01400932|143298715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.2|-15.8|||ANCOVA|||||-15.8|-26.2|<0.001
71888821|NCT01400932|143298716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
71729493|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8215
71729494|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5331||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.5331
71729495|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7365||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7365
71888822|NCT01400932|143298716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
71729496|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9989||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.9989
71729497|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2501
71729498|NCT00468845|142974009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.6021
71729499|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6613||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.6613
71729500|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1311||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)||||0.1311
71729501|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6574
71729502|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6949||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)||||0.6949
71729503|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.2008
71771608|NCT02284178|143043220|SUPERIORITY|||||||0.432|||||||GEE analysis|||||||0.432
71771609|NCT02284178|143043221|SUPERIORITY|||||||0.684|||||||GEE|||||||0.684
71771610|NCT02284178|143043222|SUPERIORITY|||||||0.858|||||||Chi-squared|||||||0.858
71771611|NCT02284178|143043224|SUPERIORITY|||||||0.46|||||||GEE analysis|||||||0.460
71771612|NCT02284178|143043225|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||0.214
71771613|NCT02284178|143043226|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
71771614|NCT02284178|143043227|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
71771615|NCT04251156|143043266|SUPERIORITY|Responses were analysed using an analysis of covariance model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Treatment difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-10.17|-6.76|||ANCOVA|||Treatment policy estimand||-6.76|-10.17|<0.0001
71771616|NCT04251156|143043267|SUPERIORITY|Responses were analysed using a binary logistic regression model with randomized treatment and type 2 diabetes status as factors and baseline body weight as covariate.|Odds Ratio (OR)|13.07|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Regression, Logistic|||Treatment policy estimand||23.10|7.40|<0.0001
71831144|NCT02528188|143167429|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.15||||0.1322|TWO_SIDED|95.0|0.96|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.37|0.96|0.1322
71729504|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.3022
71729505|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6382||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.6382
71729506|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.8624
71729507|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3858||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.3858
71729508|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4814||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4814
71729509|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.952||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.9520
71729510|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2315||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.2315
71729511|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7061||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.7061
71729512|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2908||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.2908
71729513|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4782||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4782
71729514|NCT00468845|142974010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.813||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.8130
71729515|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.894||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8940
71888823|NCT01400932|143298716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
71729516|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.5938
71729517|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4306||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.4306
71729518|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5899||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.5899
71729519|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2209||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2209
71729520|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7145||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.7145
71729521|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1022||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.1022
71729522|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS||||0.7243
71729523|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.2310
71729524|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9192||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS||||0.9192
71729525|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.3214
71729526|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8641||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS||||0.8641
71729527|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3024||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.3024
71729528|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7359||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS||||0.7359
71729529|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.4303
71729530|NCT00468845|142974011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge||||0.2133
71729531|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.5682
71729532|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1005||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS||||0.1005
71729533|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8261||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.8261
71888824|NCT01400932|143298716|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
71888825|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
71729534|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9981||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS||||0.9981
71771617|NCT01041495|143043309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.869||||0.869|TWO_SIDED|95.0||||P values below 0.05 were considered statistically significant|t-test, 2 sided|||||||.869
71771618|NCT01041495|143043310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.486|TWO_SIDED||||||t-test, 2 sided|||Visual Analogue Pain Scale (VAPS). The final visit VAPS at 8th week will be compared against baseline VAPS scores for both treatment groups||||.486
71771619|NCT01041495|143043310|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||t-test, 1 sided|||||||.486
71771620|NCT01041495|143043311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.0||||0.869|TWO_SIDED||||||t-test, 2 sided||As above- this was the difference between the groups on mean avg, it was used here|||||.869
71771621|NCT01041495|143043311|SUPERIORITY||Mean Difference (Final Values)|17.0||||0.275|TWO_SIDED||||||t-test, 1 sided|||||||.275
71771622|NCT02882074|143043312|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.158|TWO_SIDED|95.0|-0.11|0.64|||Regression, Linear|||||0.64|-0.11|0.158
71771623|NCT02882074|143043313|SUPERIORITY||Ratio of geometric means|0.86||||0.388|TWO_SIDED|97.5|0.57|1.28||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Syndecan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.28|0.57|0.388
71771624|NCT02882074|143043314|SUPERIORITY||Ratio of geometric means|1.19||||0.257|TWO_SIDED|97.5|0.84|1.68||The significance criterion is p-value \< 0.025 (i.e. 0.05/2), corrected for multiple comparisons.|Mixed Models Analysis||Endocan values were all log-transformed to meet the linearity requirement. Thus the treatment effect was presented as the ratio of geometric means.|||1.68|0.84|0.257
71771625|NCT02882074|143043315|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.003|TWO_SIDED|95.0|0.23|1.01|||Regression, Linear|||||1.01|0.23|0.003
71771626|NCT03780400|143043321|OTHER|test for within group change from baseline to 4 month follow-up||||||0.5145|||||||t-test, 2 sided|||||||0.5145
71771627|NCT03780400|143043322|OTHER|test for within group change from baseline to 4 month follow-up||||||0.3683|||||||t-test, 2 sided|||||||0.3683
71771628|NCT03780400|143043323|OTHER|test for within group change from baseline to 4 month follow-up||||||0.9858|||||||t-test, 2 sided|||||||0.9858
71771629|NCT03780400|143043324|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71771630|NCT03780400|143043325|OTHER|test for within group change from baseline to 4 month follow-up|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71771631|NCT05867342|143043360|OTHER|||||||0.77||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.77
71729535|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8884||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.8884
71729536|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4507||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS||||0.4507
71729537|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.2994
71729538|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4371||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS||||0.4371
71729539|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8295
71729540|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8783||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS||||0.8783
71771632|NCT05867342|143043361|OTHER|||||||0.002||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.002
71771633|NCT05867342|143043362|OTHER|||||||0.126||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.126
71771634|NCT05867342|143043364|OTHER|||||||0.213||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.213
71771635|NCT05867342|143043365|OTHER|||||||0.418||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.418
71771636|NCT05867342|143043366|OTHER|||||||0.756||||||A p-value of \< 0.05 would be considered statistically significant.|t-test, 2 sided|||||||0.756
71771637|NCT03190369|143043400|SUPERIORITY||LS Mean difference|0.125|STANDARD_ERROR_OF_MEAN|0.137||0.361|TWO_SIDED|95.0|-0.144|0.395||Threshold for significance at 0.05 level.|ANCOVA|Least-square (LS) means, standard errors (SE) were analyzed from repeated measures ANCOVA.||Least-square (LS) means, standard errors (SE) were analyzed from repeated measures analysis of covariance (ANCOVA). The model included treatment groups (Hylan G-F 20 and placebo), site, visit and visit by treatment interaction, as well as the baseline WOMAC A1 score as a covariate).||0.395|-0.144|0.3610
71771638|NCT01923168|143043430|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.3||||0.282|TWO_SIDED|80.0|-4.5|1.7|||Posterior mean diff. & credible interval|||||1.7|-4.5|0.282
71771639|NCT01923168|143043431|OTHER|Bayesian double criteria|Mean Difference (Final Values)|1.1||||0.697|TWO_SIDED|80.0|-1.9|4.2|||Posterior mean difference|Posterior mean difference||||4.2|-1.9|0.697
71771640|NCT01923168|143043432|OTHER|Bayesian double criteria|Mean Difference (Final Values)|-1.4||||0.435|TWO_SIDED|80.0|-12.5|9.7|||Posterior mean diff. & credible interval|||||9.7|-12.5|0.435
71771641|NCT01923168|143043433|OTHER|Bayesian double criteria|Mean Difference (Final Values)|2.4||||0.611|TWO_SIDED|80.0|-8.4|13.2|||Posterior mean diff. & credible interval|||||13.2|-8.4|0.611
71771642|NCT01255787|143043468|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|1.123||0.907|TWO_SIDED|95.0|-3.258|2.035||Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.|ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.||2.035|-3.258|0.9070
71771643|NCT01255787|143043468|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|1.114||0.3006|TWO_SIDED|95.0|-4.31|0.938|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.938|-4.310|0.3006
71888826|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
71729541|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2161||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.2161
71729542|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS||||0.0440
71729543|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3855||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.3855
71729544|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS||||0.2010
71729545|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.7104
71729546|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6107||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS||||0.6107
71729547|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6705||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.6705
71729548|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2083||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS||||0.2083
71729549|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.3234
71729550|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5938||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS||||0.5938
71888827|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
71888828|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
71729551|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9711||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.9711
71729552|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS||||0.4869
71729553|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7439||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.7439
71729554|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS||||0.8045
71729555|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5925||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.5925
71729556|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS||||0.6830
71729557|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8266||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.8266
71729558|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS||||0.1929
71729559|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.7071
71729560|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS||||0.9367
71729561|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6046||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.6046
71729562|NCT00468845|142974012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5119||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS||||0.5119
71729563|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6966||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.6966
71729564|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS||||0.1808
71729565|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2616||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2616
71729566|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1014||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.1014
71729567|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4401
71729568|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5615
71729569|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7615||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7615
71729570|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.6204
71729571|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8766||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.8766
71729572|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1717||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1717
71729573|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4065||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.4065
71729574|NCT00468845|142974013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0746
71729575|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2201||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.2201
71729576|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.0606
71771644|NCT01255787|143043468|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|1.11||0.2399|TWO_SIDED|95.0|-4.436|0.794|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||||0.794|-4.436|0.2399
71771645|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs. Timolol|Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-1.45|-0.13||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 2 and timolol||-0.13|-1.45|
71771646|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.24|||||TWO_SIDED|95.0|-1.92|-0.56||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 2 and timolol||-0.56|-1.92|
71771647|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.86|0.51||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 2 and timolol||0.51|-0.86|
71831145|NCT02528188|143167429|SUPERIORITY|The two key secondary comparisons for 'Participants with \>=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.22||||0.0262|TWO_SIDED|95.0|1.02|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=50% reduction||1.46|1.02|0.0262
71831146|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9805|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.22|0.83|0.9805
71831147|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0033|TWO_SIDED|95.0|1.1|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=70% reduction||1.61|1.10|0.0033
71831148|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.24||||0.159|TWO_SIDED|95.0|0.92|1.69|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||1.69|0.92|0.1590
71831149|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0024|TWO_SIDED|95.0|1.17|2.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: \>=90% reduction||2.11|1.17|0.0024
71888829|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
71888830|NCT01400932|143298717|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Week 1; NIL|ANCOVA|||||||0.007
71729577|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.5303
71729578|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2227||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.2227
71831150|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.20|0.83|0.9932
71888831|NCT01400932|143298717|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||Week 2; NIL|ANCOVA|||||||0.008
71729579|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8237||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8237
71888832|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
71888833|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
71888834|NCT01400932|143298717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
71888835|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; Total|ANCOVA|||||||<0.001
71888836|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; Total|ANCOVA|||||||<0.001
71888837|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; Total|ANCOVA|||||||<0.001
71888838|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; Total|ANCOVA|||||||<0.001
71729580|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7476||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.7476
71729581|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6882||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.6882
71729582|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.9689
71729583|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.501||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5010
71729584|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9143||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.9143
71729585|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7381||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.7381
71729586|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5336||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.5336
71729587|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6479||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.6479
71729588|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1133||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.1133
71729589|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7637||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.7637
71729590|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1056||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1056
71729591|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8079||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.8079
71729592|NCT00468845|142974014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0917
71729593|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7511||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7511
71729594|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6742||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6742
71729595|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3808||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.3808
71729596|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7021||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7021
71729597|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0045
71729598|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7916||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.7916
71729599|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3682||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.3682
71729600|NCT00468845|142974015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1419||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1419
71729601|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.3323
71729602|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5662||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS||||0.5662
71729603|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9538||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.9538
71729604|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4592||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS||||0.4592
71729605|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.4793
71729606|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8517||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS||||0.8517
71729607|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1829||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.1829
71729608|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3544||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS||||0.3544
71729609|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.1718
71729610|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS||||0.5078
71729611|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2443||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.2443
71729612|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8296||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS||||0.8296
71729613|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3243||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3243
71729614|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3755||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)||||0.3755
71729615|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9584||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.9584
71729616|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)||||0.1187
71729617|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7915||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.7915
71729618|NCT00468845|142974016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)||||0.0703
71729619|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1975||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.1975
71729620|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2784||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;||||0.2784
71729621|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0271
71729622|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0881||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0881
71729623|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0159||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0159
71729624|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.1870
71888839|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; Total|ANCOVA|||||||<0.001
71888840|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1; IL|ANCOVA|||||||<0.001
71888841|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; IL|ANCOVA|||||||<0.001
71888842|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; IL|ANCOVA|||||||<0.001
71729625|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1752||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.1752
71888843|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; IL|ANCOVA|||||||<0.001
71888844|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; IL|ANCOVA|||||||<0.001
71888845|NCT01400932|143298718|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Week 1; NIL|ANCOVA|||||||0.002
71729626|NCT00468845|142974017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6923||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6923
71729627|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6295||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6295
71729628|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.689||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6890
71729629|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5094||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.5094
71729630|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8741||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.8741
71729631|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.0214
71729632|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9366||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.9366
71729633|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7833||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.7833
71729634|NCT00468845|142974020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2983||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.2983
71729635|NCT00468845|142974023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6861||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.6861
71729636|NCT00468845|142974023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day||||0.9905
71729637|NCT00468845|142974024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4264||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.4264
71729638|NCT00468845|142974024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3045||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS||||0.3045
71729639|NCT00468845|142974025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0714||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.0714
71729640|NCT00468845|142974025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4455||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS||||0.4455
71729641|NCT00468845|142974026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7418||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.7418
71729642|NCT00468845|142974026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5154||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS||||0.5154
71729643|NCT00468845|142974027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6715||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.6715
71729644|NCT00468845|142974027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9013||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS||||0.9013
71729645|NCT00468845|142974028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9126||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||0.9126
71729646|NCT00468845|142974028|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS||||1.0000
71888846|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2; NIL|ANCOVA|||||||<0.001
71831151|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4374|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=30% reduction||1.29|0.90|0.4374
71729647|NCT00468845|142974029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1233||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1233
71729648|NCT00468845|142974029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1666||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge||||0.1666
71729649|NCT00468845|142974030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0361||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0361
71729650|NCT00468845|142974030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0797||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7||||0.0797
71729651|NCT00468845|142974031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0206
71729652|NCT00468845|142974031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14||||0.0011
71729653|NCT00468845|142974033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3506||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours||||0.3506
71729654|NCT00468845|142974034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.0287
71729655|NCT00468845|142974034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28||||0.2270
71729656|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1872||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.1872
71729657|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3994||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge||||0.3994
71729658|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0422||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.0422
71729659|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3647||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28||||0.3647
71729660|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1729||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.1729
71729661|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2234||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge||||0.2234
71729662|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.095||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.0950
71729663|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4345||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28||||0.4345
71729664|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.2840
71831152|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4406|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.28|0.90|0.4406
71831153|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4078|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=50% reduction||1.29|0.90|0.4078
71729665|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6404||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge||||0.6404
71729666|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.0550
71729667|NCT00468845|142974035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4531||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28||||0.4531
71729668|NCT00468845|142974036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9712||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.9712
71729669|NCT00468845|142974036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.0112
71729670|NCT00468845|142974036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0090
71729671|NCT00468845|142974036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.8650
71729672|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8914||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.8914
71729673|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2214||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge||||0.2214
71729674|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.1008
71729675|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9135||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28||||0.9135
71729676|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.5609
71729677|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge||||0.4047
71729678|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1663||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.1663
71729679|NCT00468845|142974037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28||||0.8364
71729680|NCT00468845|142974038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7218||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7218
71729681|NCT00468845|142974038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4425||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.4425
71729682|NCT00468845|142974039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7889||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.7889
71729683|NCT00468845|142974039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1565||95.0|||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;||||0.1565
71729684|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6211||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.6211
71771648|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.43|-0.11||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 2 and timolol||-0.11|-1.43|
71771649|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.63|0.82||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 2 and timolol||0.82|-0.63|
71771650|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.89|0.57||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 2 and timolol||0.57|-0.89|
71888847|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4; NIL|ANCOVA|||||||<0.001
71888848|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8; NIL|ANCOVA|||||||<0.001
71888849|NCT01400932|143298718|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12; NIL|ANCOVA|||||||<0.001
71771651|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.72|||||TWO_SIDED|95.0|-1.38|-0.06||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 8AM Difference between Implant Group 1 vs. Timolol||-0.06|-1.38|
71888850|NCT01400932|143298719|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71888851|NCT01400932|143298720|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||Week 1|ANCOVA|||||||0.174
71888852|NCT01400932|143298720|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Week 2|ANCOVA|||||||0.013
71888853|NCT01400932|143298720|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 4|ANCOVA|||||||0.001
71888854|NCT01400932|143298720|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Week 8|ANCOVA|||||||0.001
71888855|NCT01400932|143298720|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
71888856|NCT01400932|143298721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 1|ANCOVA|||||||<0.001
71888857|NCT01400932|143298721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 2|ANCOVA|||||||<0.001
71888858|NCT01400932|143298721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 4|ANCOVA|||||||<0.001
71888859|NCT01400932|143298721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 8|ANCOVA|||||||<0.001
71729685|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3687||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale||||0.3687
71729686|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7078||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.7078
71729687|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8696||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale||||0.8696
71729688|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.4320
71729689|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8843||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale||||0.8843
71729690|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6215||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.6215
71729691|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2722||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale||||0.2722
71729692|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.5500
71729693|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9942||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale||||0.9942
71729694|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0075||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.0075
71729695|NCT00468845|142974040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1464||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia||||0.1464
71771652|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.83|-0.48||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Day 10, 10AM Difference between Implant Group 1 vs. Timolol||-0.48|-1.83|
71771653|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.93|0.43||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 8AM Difference between Implant Group 1 and timolol||0.43|-0.93|
71729696|NCT00468845|142974041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9877||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.9877
71729697|NCT00468845|142974041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1334||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.||||0.1334
71729698|NCT00468845|142974041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3566||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.3566
71729699|NCT00468845|142974041|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6262||95.0|||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.||||0.6262
71771654|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|95.0|-1.4|-0.08||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Week 6, 10AM Difference between Implant Group 1 and timolol||-0.08|-1.40|
71888860|NCT01400932|143298721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Week 12|ANCOVA|||||||<0.001
71888861|NCT01276821|143298730|NON_INFERIORITY_OR_EQUIVALENCE|Non - Inferiority Analysis|Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|1.3|<|0.05|TWO_SIDED|95.0|0.78|1.82|||t-test, 2 sided|||"Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.~Alternate Hypothesis:~Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis."||1.82|0.78|<0.05
71729700|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.9463
71729701|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7347||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;||||0.7347
71729702|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4132||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4132
71729703|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4929||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;||||0.4929
71729704|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6003||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.6003
71729705|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;||||0.9343
71729706|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3838||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.3838
71729707|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;||||0.1351
71729708|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3343||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.3343
71729709|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7948||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;||||0.7948
71729710|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.8090
71729711|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4035||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;||||0.4035
71729712|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6009||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.6009
71729713|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7597||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge||||0.7597
71729714|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7804||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.7804
71729715|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0463||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7||||0.0463
71729716|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.4951
71729717|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14||||0.3030
71729718|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.0104
71729719|NCT00468845|142974042|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||95.0|||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28||||0.6978
71729720|NCT03840525|142974059|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted. No group comparisons were done due to the fact that this was a feasibility trial and not an efficacy trial. 80% was used as the benchmark for acceptability.|||
71729721|NCT03840525|142974060|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics was conducted to determine acceptability for both the qigong and sham qigong group. No between group comparisons were conducted. A benchmark of 80% was used to determine acceptability.|||
71729722|NCT03840525|142974061|EQUIVALENCE|To estimate precision, 95%CI will be calculated using Wilson's score method, which uses asymptotic variance and is appropriate for small sample sizes100. The formula is as follows: (2np + z2 ± √(z2 + 4npq)) / 2(n+ z2). If the proportion of participants who rate the intervention as acceptable is 80% or greater, we will consider the intervention acceptable.|||||||||||||||||Descriptive statistics were conducted to determine acceptability. Benchmark for acceptability was set at 80% of participant attending at least 70% of the classes.|||
71729723|NCT01370837|142974071|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.84
71729724|NCT01370837|142974071|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.76
71729725|NCT01370837|142974071|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Kruskal-Wallis|||Arm||||0.53
71729726|NCT01370837|142974071|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Kruskal-Wallis|||Foot||||0.07
71729727|NCT01370837|142974071|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.25
71729728|NCT01370837|142974071|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||0.27
71729729|NCT01370837|142974071|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Arm vs foot||||< 0.01
71729730|NCT04240093|142974085|SUPERIORITY|This is a pilot intervention trial and was not powered to detect statistical significance.|Beta coefficient|-0.46|STANDARD_ERROR_OF_MEAN|0.33||0.17|TWO_SIDED|95.0|-1.11|0.2||a priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equations (GEE) with a poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication doses in the past 30 days at follow-up.||0.20|-1.11|0.17
71729731|NCT04240093|142974086|SUPERIORITY|This pilot feasibility and acceptability study was not powered to detect a statistically significant effect.|Beta coefficient|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.09|2.72||a priori alpha p\<0.05|Generalized estimating equation (GEE)|Generalized estimating equations (GEE) with a Poisson distribution controlling for baseline values.||Hypothesis: The CoMBAT intervention arm would be superior to the Standard of Care control arm with regard to reductions in missed medication-related visits in the past 30 days at follow-up.||2.72|-3.09|0.90
71771655|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.62|0.83||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 8AM Difference between Implant Group 1 and timolol||0.83|-0.62|
71729732|NCT04240093|142974087|SUPERIORITY|As a pilot feasibility and acceptability trial, this study was not powered to detect a statistically significant effect.|Beta coefficient|-4.71|STANDARD_ERROR_OF_MEAN|2.05||0.02|TWO_SIDED|95.0|-8.72|-0.7||A priori alpha p\<0.05|Generalized estimating equations (GEE)|Generalized estimating equation (GEE) modeling with a binomial distribution, controlling for baseline values.||Hypothesis: Fewer participants in the CoMBAT experimental arm will have a positive opioid toxicology screen at the 6-month follow-up compared to participants in the SOC control arm.||-0.70|-8.72|0.02
71729733|NCT02839902|142974088|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-17.147||||0.0004|TWO_SIDED|95.0|-26.344|-7.95|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-7.950|-26.344|0.0004
71729734|NCT02839902|142974088|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-9.774||||0.1141|TWO_SIDED|95.0|-21.986|2.439|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.||2.439|-21.986|0.1141
71729735|NCT02839902|142974088|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-10.246||||0.0248|TWO_SIDED|95.0|-19.143|-1.349|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-1.349|-19.143|0.0248
71729736|NCT02839902|142974088|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|-11.511||||0.0047|TWO_SIDED|95.0|-19.34|-3.682|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.||-3.682|-19.340|0.0047
71729737|NCT02839902|142974089|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|9.499||||0.1826|TWO_SIDED|95.0|-4.623|23.622|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.||23.622|-4.623|0.1826
71729738|NCT02839902|142974090|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.066||||0.004|TWO_SIDED|95.0|0.356|1.776|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.||1.776|0.356|0.0040
71729739|NCT02839902|142974090|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|1.553||||0.4428|TWO_SIDED|95.0|-2.884|5.991|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.||5.991|-2.884|0.4428
71729740|NCT02839902|142974090|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.76||||0.057|TWO_SIDED|95.0|-0.024|1.544|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.||1.544|-0.024|0.0570
71729741|NCT02839902|142974090|OTHER|Least square (LS) mean difference|Least square (LS) mean difference|0.838||||0.036|TWO_SIDED|95.0|0.057|1.62|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.||1.620|0.057|0.0360
71771656|NCT03519386|143043486|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.77|0.69||"Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group~1 to timolol"||||Month 3, 10AM Difference between Implant Group 1 and timolol||0.69|-0.77|
71771657|NCT02398227|143043525|SUPERIORITY|||||||0.968|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.968
71771658|NCT02398227|143043526|SUPERIORITY|||||||0.56|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms||||||.560
71771659|NCT04473482|143043544|SUPERIORITY|Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios|Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|||||||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios||Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals|||
71771660|NCT04473482|143043545|SUPERIORITY||Odds Ratio (OR)|2.31|||||TWO_SIDED|95.0|||||||GEEs with robust sandwich estimators and Wald 95% CIs with conversion to Odds Ratios|||||
71771661|NCT01306877|143043551|NON_INFERIORITY_OR_EQUIVALENCE|The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe's generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is \<7%.|Risk Difference (RD)|-0.314||||0.0001|ONE_SIDED|95.0||-0.18||P-value calculated from per protocol analysis set|Chi-squared|||||-0.18||0.0001
71771662|NCT01306877|143043555|SUPERIORITY_OR_OTHER|||||||0.1844|||||||Wilcoxon (Mann-Whitney)|||||||0.1844
71771663|NCT01306877|143043556|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Wilcoxon (Mann-Whitney)|||||||0.5647
71771664|NCT01306877|143043557|SUPERIORITY_OR_OTHER|||||||0.9062|||||||Wilcoxon (Mann-Whitney)|||||||0.9062
71771665|NCT02376283|143043578|OTHER|A p value \< 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student's independent sample t-tests. Categorical variables assessed using separate Fisher's exact (Chi-square) test.||||<0.05
71831154|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4071|TWO_SIDED|95.0|0.89|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.31|0.89|0.4071
71771666|NCT02376283|143043578|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001|||||||ANOVA|ANOVA F(3,36) = 12.282||STEMI- clop vs prasl vs tic||||< 0.0001
71729742|NCT00740714|142974113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.85|>|0.025|TWO_SIDED|97.5|-1.33|2.51||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.||2.51|-1.33|>0.025
71831155|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0248|TWO_SIDED|95.0|1.03|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=70% reduction||1.50|1.03|0.0248
71729743|NCT00740714|142974113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|0.86|>|0.025|TWO_SIDED|95.0|-0.85|3.03||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.||3.03|-0.85|>0.025
71729744|NCT00740714|142974114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.84||0.7943|TWO_SIDED|97.5|-2.12|1.68||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.68|-2.12|0.7943
71729745|NCT00740714|142974114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.85||0.306||95.0|-2.79|1.04||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month on Modified Schwab \& England will be analyzed using ANCOVA in the same way as for the primary outcome variable.||1.04|-2.79|0.306
71729746|NCT00740714|142974115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|<|0.1615|TWO_SIDED|97.5|-0.25|0.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.06|-0.25|<0.1615
71729747|NCT00740714|142974115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7627|TWO_SIDED|95.0|-0.17|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.17|0.7627
71729748|NCT00740714|142974116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6383|STANDARD_ERROR_OF_MEAN|1.18||0.6383|TWO_SIDED|97.5|-2.1|3.21||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.21|-2.10|0.6383
71729749|NCT00740714|142974116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|1.19||0.667|TWO_SIDED|95.0|-3.2|2.17||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.||2.17|-3.20|0.667
71729750|NCT00740714|142974117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|1.14||0.671|TWO_SIDED|97.5|-2.09|3.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.||3.06|-2.09|0.671
71729751|NCT00740714|142974117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.16||0.671|TWO_SIDED|95.0|-3.34|1.87||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable||1.87|-3.34|0.671
71888862|NCT02939131|143298754|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not. The study was designed for at least 80% power to detect an effect size of 0.8 standard deviations (SD), which corresponded to a difference of four points. We assumed an intracluster correlation coefficient (ICC) between 0.02 and 0.16 and allowed for 10% non-evaluability. In a pre-planned interim analysis, we estimated the ICC based on the entry QIDS-SR to be 0.10.|Mean Difference (Final Values)|-3.86||||0.01|TWO_SIDED|95.0|-6.79|-0.94|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|||-0.94|-6.79|0.01
71888863|NCT02939131|143298755|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|44.3|||<|0.001|TWO_SIDED|95.0|23.1|65.5|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|||65.5|23.1|<0.001
71771667|NCT02376283|143043578|OTHER|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(2,40) = 29.097||NSTEMI- clopidogrel vs prasugrel vs ticagrelor||||< 0.0001
71831156|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.88||||0.3641|TWO_SIDED|95.0|0.66|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.16|0.66|0.3641
71831157|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2497|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: \>=90% reduction||1.53|0.89|0.2497
71888864|NCT02939131|143298756|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|30.9||||0.01|TWO_SIDED|95.0|8.9|52.9|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|||52.9|8.9|0.01
71831158|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8682|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.21|0.85|0.8682
71831159|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7317|TWO_SIDED|95.0|0.81|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=30% reduction||1.16|0.81|0.7317
71831160|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6493|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6493
71831161|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.98||||0.7973|TWO_SIDED|95.0|0.82|1.17|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=50% reduction||1.17|0.82|0.7973
71831162|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0757|TWO_SIDED|95.0|0.98|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.45|0.98|0.0757
71831163|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.21||||0.0578|TWO_SIDED|95.0|0.99|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=70% reduction||1.47|0.99|0.0578
71888865|NCT02939131|143298757|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|19.0||||0.86|TWO_SIDED|95.0|-223.0|262.0|||t-test, 2 sided||Group mean for ESC is subtracted from the group mean for COMB-R. The group means are the means of the site mean CD4 cell counts.|||262|-223|0.86
71888866|NCT02939131|143298758|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.17||||0.66|TWO_SIDED|95.0|-0.65|0.99|||t-test, 2 sided||We subtracted the group mean for the ESC group from the group mean of the COMB-R group. The group means are the means of the site mean log10 HIV RNA copies/mL.|||0.99|-0.65|0.66
71831164|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.76|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.37|0.76|0.9010
71831165|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0548|TWO_SIDED|95.0|0.99|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: \>=90% reduction||1.74|0.99|0.0548
71831166|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7331|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.23|0.86|0.7331
71831167|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.98||||0.8632|TWO_SIDED|95.0|0.82|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=30% reduction||1.18|0.82|0.8632
71831168|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6262|TWO_SIDED|95.0|0.88|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.25|0.88|0.6262
71729752|NCT00740714|142974118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3445|TWO_SIDED|97.5|-0.04|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Hoehn \& Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.13|-0.04|0.3445
71729753|NCT00740714|142974118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.05||0.239||95.0|-0.04|0.14||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.||Change from Baseline visit to 16-month visit on Hoehn \& Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.||0.14|-0.04|.239
71729754|NCT00740714|142974119|SUPERIORITY_OR_OTHER||Slope|0.536|STANDARD_ERROR_OF_MEAN|0.282||0.0577|TWO_SIDED|95.0|-0.018|1.091|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.||1.091|-0.018|0.0577
71729755|NCT00740714|142974119|SUPERIORITY_OR_OTHER||Slope|0.245|STANDARD_ERROR_OF_MEAN|0.451||0.5889|TWO_SIDED|95.0|-0.647|1.136|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.||1.136|-0.647|0.5889
71729756|NCT00740714|142974119|SUPERIORITY_OR_OTHER||Slope|0.631|STANDARD_ERROR_OF_MEAN|0.608||0.3006|TWO_SIDED|95.0|-0.569|1.831|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.||1.831|-0.569|0.3006
71729757|NCT00740714|142974119|SUPERIORITY_OR_OTHER||Slope|2.126|STANDARD_ERROR_OF_MEAN|1.269||0.096|TWO_SIDED|95.0|-0.382|4.633|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.||4.633|-0.382|0.096
71729758|NCT00740714|142974120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.57|2.8|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||2.80|0.57|<0.05
71729759|NCT00740714|142974121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.62|3.57|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience||3.57|0.62|<0.05
71729760|NCT00740714|142974122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.65|4.2|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||4.20|0.65|<0.05
71729761|NCT00740714|142974123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.46|1.79|||ANCOVA||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.79|0.46|<0.05
71729762|NCT00740714|142974124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.0199|<|0.05|TWO_SIDED|95.0|0.66|3.41|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.41|0.66|<0.05
71729763|NCT00740714|142974125|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.81|9.72|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9.72|0.81|<0.05
71729764|NCT00740714|142974126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.52|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.52|0.31|<0.05
71831169|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6817|TWO_SIDED|95.0|0.81|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=50% reduction||1.15|0.81|0.6817
71729765|NCT00740714|142974127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.70|0.36|<0.05
71771668|NCT02376283|143043579|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
71831170|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.03||||0.799|TWO_SIDED|95.0|0.85|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.24|0.85|0.7990
71831171|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6786|TWO_SIDED|95.0|0.86|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=70% reduction||1.26|0.86|0.6786
71831172|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8069|TWO_SIDED|95.0|0.78|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.38|0.78|0.8069
71831173|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2951|TWO_SIDED|95.0|0.88|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: \>=90% reduction||1.54|0.88|0.2951
71831174|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9093|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.21|0.85|0.9093
71831175|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5032|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5032
71831176|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4382|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4382
71729766|NCT00740714|142974128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.69|8.58|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.58|0.69|<0.05
71831177|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.95||||0.5638|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=50% reduction||1.13|0.79|0.5638
71831178|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.05||||0.6436|TWO_SIDED|95.0|0.86|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.27|0.86|0.6436
71831179|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.04||||0.706|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=70% reduction||1.26|0.85|0.7060
71831180|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7729|TWO_SIDED|95.0|0.72|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.28|0.72|0.7729
71831181|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.07||||0.6405|TWO_SIDED|95.0|0.81|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: \>=90% reduction||1.42|0.81|0.6405
71831182|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9046|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.21|0.85|0.9046
71771669|NCT02376283|143043579|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||=|0.123|||||||ANOVA|ANOVA F(6,56)=1.707||STEMI- different drugs (as stated above)||||=0.123
71771670|NCT02376283|143043579|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(4,62)=18.932||NSTEMI- different drugs (as stated above)||||<0.0001
71771671|NCT02376283|143043580|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||<0.05
71771672|NCT02376283|143043580|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||=|0.81||||||STEMI- clopidogrel vs prasugrel vs ticagrelor|ANOVA|ANOVA F(3,17) = 0.321||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||=0.810
71771673|NCT02376283|143043580|OTHER|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.0001||||||NSTEMI- clopi vs pras vs tic|ANOVA|ANOVA F(2,25) = 14.103||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student's independent sample t-tests. Categorical variables were assessed using separate Fisher's exact (Chi-square) test."||||< 0.0001
71771674|NCT01076075|143043585|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.68|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-0.50|-0.87|<0.001
71771675|NCT01076075|143043586|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-33.5|||<|0.001|TWO_SIDED|95.0|-45.3|-21.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, difference in the Least Squares Means.||-21.7|-45.3|<0.001
71771676|NCT01076075|143043587|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-18.6|||<|0.001|TWO_SIDED|95.0|-26.4|-10.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.||-10.7|-26.4|<0.001
71771677|NCT02101112|143043643|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.054|||||TWO_SIDED|90.0|0.994|1.118||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.118|0.994|
71771678|NCT02101112|143043643|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.788|||||TWO_SIDED|90.0|0.741|0.839||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.839|0.741|
71771679|NCT02101112|143043644|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.076||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.076|0.981|
71771680|NCT02101112|143043644|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.835|||||TWO_SIDED|90.0|0.797|0.875||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.875|0.797|
71831183|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.93||||0.4491|TWO_SIDED|95.0|0.78|1.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=30% reduction||1.11|0.78|0.4491
71831184|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7429|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.23|0.86|0.7429
71771681|NCT02101112|143043645|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|1.027|||||TWO_SIDED|90.0|0.981|1.075||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)||1.075|0.981|
71831185|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3467|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=50% reduction||1.10|0.77|0.3467
71888867|NCT02939131|143298759|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|95.0|0.1|4.0|||t-test, 2 sided||A positive difference indicates COMB-R group had a site-level average of more days in last 30 with missed HIV medication doses.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 24.||4.0|0.1|0.04
71729767|NCT00740714|142974129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.31|1.62|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.62|0.31|<0.05
71729768|NCT00740714|142974130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.77|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.77|<0.05
71729769|NCT00740714|142974131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.25|1.12|||Fisher Exact||Odds ration \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||1.12|0.25|<0.05
71771682|NCT02101112|143043645|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|0.832|||||TWO_SIDED|90.0|0.794|0.871||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)||0.871|0.794|
71771683|NCT04340063|143043650|OTHER||Odds Ratio, log|0.4|||<|0.001|TWO_SIDED|95.0|0.25|0.55||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant was used and fixed effects were time (assessment order) and a time by group interaction (Treadmill or Movement Amplification). A binomial distribution was used for this model.||0.55|0.25|<0.001
71771684|NCT04340063|143043650|OTHER||Odds Ratio, log|-0.03||||0.8|TWO_SIDED|95.0|-0.22|0.16||Interaction effect for time (pre-, mid-, and post- assessments) by group (Movement Amplification)|Mixed Models Analysis|||||0.16|-0.22|0.8
71771685|NCT04340063|143043650|OTHER||Odds Ratio, log|0.09||||0.5|TWO_SIDED|95.0|-0.18|0.36||Effect of time (post-training and follow-up assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.36|-0.18|0.5
71771686|NCT04340063|143043650|OTHER||Odds Ratio, log|-0.07||||0.6|TWO_SIDED|95.0|-0.31|0.17||Interaction effect of time (post-training and follow-up assessments) by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used. A binomial distribution was used for this model.||0.17|-0.31|0.6
71831186|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.85|0.7624
71831187|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7686|TWO_SIDED|95.0|0.8|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=70% reduction||1.18|0.80|0.7686
71831188|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9384|TWO_SIDED|95.0|0.74|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.33|0.74|0.9384
71888868|NCT02939131|143298759|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.96|TWO_SIDED|95.0|-5.0|5.2|||t-test, 2 sided||A positive difference reflects greater number of days with missed HIV medication doses in last 30 days for COMB-R group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed HIV medication doses reported at week 48.||5.2|-5.0|0.96
71729770|NCT00740714|142974132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|0.64|8.01|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||8.01|0.64|<0.05
71771687|NCT04340063|143043651|OTHER||Slope|0.06||||0.8|TWO_SIDED|95.0|-0.5|0.62||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and time by group (Treadmill or Movement Amplification) interaction were used||0.62|-0.50|0.8
71771688|NCT04340063|143043651|OTHER||Slope|-0.7||||0.012|TWO_SIDED|95.0|-1.2|-0.16||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||-0.16|-1.2|0.012
71831189|NCT02528188|143167429|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8495|TWO_SIDED|95.0|0.77|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: \>=90% reduction||1.38|0.77|0.8495
71888869|NCT02939131|143298760|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.27|TWO_SIDED|95.0|-1.1|0.4|||t-test, 2 sided||A positive difference means the COMB-R group rated adherence to HIV medications better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 24.||0.4|-1.1|0.27
71729771|NCT00740714|142974133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|STANDARD_ERROR_OF_MEAN|0.0198|<|0.05|TWO_SIDED|95.0|0.55|3.24|||Fisher Exact||Odds ratio of \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||3.24|0.55|<0.05
71729772|NCT00740714|142974134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0197|<|0.05|TWO_SIDED|95.0|0.48|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|0.48|<0.05
71729773|NCT00740714|142974135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9999.98|STANDARD_ERROR_OF_MEAN|0.0196|<|0.05|TWO_SIDED|95.0|2.51|9999.99|||Fisher Exact||Odds ratio \>1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.||9999.99|2.51|<0.05
71729774|NCT03688555|142974136|SUPERIORITY||LS means difference|0.76|STANDARD_ERROR_OF_MEAN|0.301|=|0.062|TWO_SIDED|95.0|-0.06|1.59||All Nasal Polyp Score (NPS) values observed between baseline and Week 12 were included in the analysis. Changes from baseline to post-baseline visits in NPS were analyzed using a Mixed Model for Repeated Measurement (MMRM).|Mixed model for repeated measurements|||||1.59|-0.06|= 0.062
71729775|NCT03688555|142974137|SUPERIORITY||LS means difference|-3.98|STANDARD_ERROR_OF_MEAN|2.316|=|0.161|TWO_SIDED|95.0|-10.41|2.45|||ANCOVA|||||2.45|-10.41|= 0.161
71729776|NCT01294462|142974162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.53||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.53|0.94|
71661162|NCT03786718|142835931|OTHER|||||||0.02|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in General Diet sub-scale score||||0.02
71729777|NCT01294462|142974163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.88|2.44||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.44|0.88|
71729778|NCT01294462|142974164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72|||||TWO_SIDED|95.0|1.23|2.4||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison.||2.40|1.23|
71729779|NCT01294462|142974165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|95.0|0.91|2.5||No P-value provided since the objective was not to perform formal statistical comparison.|Regression, Cox|Analyzed based on proportional hazards model including treatment group only.|Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.||2.50|0.91|
71729780|NCT02076399|142974166|SUPERIORITY||Risk Difference (RD)|17.6||||0.0261|TWO_SIDED|95.0|7.2|28.1|||Fisher Exact|||||28.1|7.2|0.0261
71729781|NCT02076399|142974171|SUPERIORITY||Risk Difference (RD)|-0.01||||0.6642|TWO_SIDED|95.0|-0.01|0.0||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.0|-0.01|0.6642
71888870|NCT02939131|143298760|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how good was participant at taking HIV medication doses; reported at week 48.||0.9|-0.4|0.44
71661163|NCT03786718|142835931|OTHER|||||||0.13|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Specific Diet sub-scale score||||0.13
71661164|NCT03786718|142835931|OTHER|||||||0.35|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Exercise sub-scale score||||0.35
71729782|NCT02076399|142974172|SUPERIORITY||Risk Difference (RD)|0.15||||0.3365|TWO_SIDED|95.0|-0.2|0.5||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.5|-0.2|0.3365
71729783|NCT01400243|142974183|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANCOVA|||||||.05
71729784|NCT01400243|142974184|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71729785|NCT02032641|142974190|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||<0.05
71729786|NCT02032641|142974190|SUPERIORITY_OR_OTHER||||||>|0.1||||||The threshold for significance is p\<0.05|t-test, 1 sided|||||||>0.10
71729787|NCT01048866|142974195|SUPERIORITY_OR_OTHER||least-square means difference|-196.6||||0.0021|TWO_SIDED|95.0|-321.0|-72.2||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-72.2|-321.0|0.0021
71729788|NCT01048866|142974196|SUPERIORITY_OR_OTHER||least-square means difference|-19.0||||0.0002|TWO_SIDED|95.0|-28.7|-9.3||The a priori threshold for statistical significance is 0.05.|ANOVA|Baseline DSS fitted as a covariate and centre as a fixed effect.||||-9.3|-28.7|0.0002
71729789|NCT01048866|142974197|SUPERIORITY_OR_OTHER||least-square means difference|-179.7||||0.0054|TWO_SIDED|95.0|-305.7|-53.8||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-53.8|-305.7|0.0054
71729790|NCT01048866|142974198|SUPERIORITY_OR_OTHER||least-square means difference|-16.4||||0.0008|TWO_SIDED|95.0|-25.9|-7.0||The a priori threshold for statistical significance is 0.05.|ANOVA|||||-7.0|-25.9|0.0008
71729791|NCT01048866|142974199|SUPERIORITY_OR_OTHER||least-square means difference|-168.4||||0.0087|TWO_SIDED|95.0|-293.7|-43.1|||ANOVA|||||-43.1|-293.7|0.0087
71729792|NCT01048866|142974200|SUPERIORITY_OR_OTHER||least-square means difference|-19.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-10.0|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||-10.0|-28.0|<0.0001
71729793|NCT01048866|142974201|SUPERIORITY_OR_OTHER||least-square means difference|-118.9||||0.1844|TWO_SIDED|95.0|-295.3|57.5|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.||||57.5|-295.3|0.1844
71729794|NCT01048866|142974202|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71729795|NCT01048866|142974203|SUPERIORITY_OR_OTHER|||||||0.8827|||||||Wilcoxon (Mann-Whitney)|||||||0.8827
71771689|NCT04340063|143043651|OTHER||Slope|0.26||||0.3|TWO_SIDED|95.0|-0.22|0.75||Effect of time (post-training to follow-up)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.75|-0.22|0.3
71771690|NCT04340063|143043651|OTHER||Slope|-0.2||||0.4|TWO_SIDED|95.0|-0.69|0.29||Interaction effect of time (post-training to follow-up) by group|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the post-training and follow-up assessments if an effect was found during training. Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||0.29|-0.69|0.4
71771691|NCT04340063|143043652|OTHER||Slope|-52.0||||0.9|TWO_SIDED|95.0|-651.0|456.0||Effect of time (pre-, mid-, and post- assessments)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||456|-651|0.9
71888871|NCT02939131|143298761|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.14|TWO_SIDED|95.0|-1.1|0.2|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 24.||0.2|-1.1|0.14
71888872|NCT02939131|143298761|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.49|TWO_SIDED|95.0|-0.6|1.1|||t-test, 2 sided||A positive difference would indicate the COMB-R group rated their adherence better than the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take HIV medication as instructed; reported at week 48.||1.1|-0.6|0.49
71729796|NCT01048866|142974204|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon (Mann-Whitney)|Stratified by centre||||||0.0105
71729797|NCT01048866|142974206|SUPERIORITY_OR_OTHER||least-square means difference|-5.9||||0.0743|TWO_SIDED|95.0|-12.4|0.6|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.6|-12.4|0.0743
71771692|NCT04340063|143043652|OTHER||Slope|79.0||||0.8|TWO_SIDED|95.0|-622.0|780.0||Interaction effect of time by group (Movement Amplification)|Mixed Models Analysis|||A linear mixed-effects model (LMM) evaluated the effect of training (pre-, mid-, and post- assessments). Random effect of participant and fixed effects of time (assessment order) and the time by group (Treadmill or Movement Amplification) interaction were used.||780|-622|0.8
71771693|NCT01857583|143043670|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.6|||||TWO_SIDED|95.0|-10.0|33.6|||ANCOVA|||||33.6|-10.0|
71771694|NCT01857583|143043670|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|17.3|||||TWO_SIDED|95.0|-10.2|42.1|||ANCOVA|||||42.1|-10.2|
71771695|NCT04894916|143043686|OTHER|single group|mean|81.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||"One-sample t-test comparing the sample mean to the threshold value of 71 indicative of good usability. The null hypothesis: true mean is equal to 71."||||<0.001
71771696|NCT04894916|143043689|SUPERIORITY||Mean Difference (Net)|0.73|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71771697|NCT04894916|143043690|OTHER||Mean Difference (Net)|1.17||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71771698|NCT04894916|143043691|OTHER|||||||0.68|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.68
71771699|NCT04894916|143043691|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.18
71771700|NCT04894916|143043691|OTHER|||||||0.18|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.18
71729798|NCT01048866|142974207|SUPERIORITY_OR_OTHER||least-square means difference|-5.5||||0.0871|TWO_SIDED|95.0|-11.7|0.8|||ANOVA|Repeated measures ANOVA model with patient as a random effect.||||0.8|-11.7|0.0871
71729799|NCT01048866|142974208|SUPERIORITY_OR_OTHER||least-square means difference|-6.0||||0.0595|TWO_SIDED|95.0|-12.3|0.2|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.2|-12.3|0.0595
71729800|NCT01048866|142974209|SUPERIORITY_OR_OTHER||least-square means difference|0.5||||0.0195|TWO_SIDED|95.0|0.1|0.9|||ANOVA|Repeated measures ANOVA model with participant as a random effect.||||0.9|0.1|0.0195
71771701|NCT04894916|143043691|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.17
71771702|NCT04894916|143043691|OTHER|||||||0.33|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.33
71771703|NCT04894916|143043691|OTHER|||||||0.4|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.40
71771704|NCT04894916|143043691|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
71771705|NCT04894916|143043691|OTHER|||||||0.37|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||0.37
71771706|NCT04894916|143043692|OTHER||Mean Difference (Net)|-0.71||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
71771707|NCT04894916|143043693|OTHER|||||||0.03|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.03
71771708|NCT04894916|143043693|OTHER|||||||0.45|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||0.45
71771709|NCT04894916|143043693|OTHER|||||||0.17|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.||||0.17
71771710|NCT04894916|143043693|OTHER|||||||0.62|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.62
71771711|NCT04894916|143043695|OTHER||Mean Difference (Net)|0.09||||0.53|TWO_SIDED||||||t-test, 2 sided|||||||0.53
71771712|NCT04894916|143043696|OTHER||Mean Difference (Net)|0.03||||0.86|TWO_SIDED||||||t-test, 2 sided|||||||0.86
71771713|NCT04894916|143043697|OTHER||Mean Difference (Net)|0.28||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71771714|NCT04894916|143043698|OTHER||Mean Difference (Net)|0.25||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
71771715|NCT04894916|143043699|OTHER||Mean Difference (Net)|-0.39||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
71771716|NCT00396032|143043700|SUPERIORITY_OR_OTHER|||||||0.0044||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0044
71729801|NCT01048866|142974210|SUPERIORITY_OR_OTHER|||||||0.0322|||||||Regression, Logistic|Effect for centre||||||0.0322
71729802|NCT01048866|142974211|SUPERIORITY_OR_OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
71729803|NCT01048866|142974212|SUPERIORITY_OR_OTHER||least-square means difference|-0.2||||0.0288|TWO_SIDED|95.0|-0.4|0.0|||ANOVA|||||-0.0|-0.4|0.0288
71729804|NCT01048866|142974213|SUPERIORITY_OR_OTHER||least-square means difference|-0.1||||0.4274|TWO_SIDED|95.0|-0.3|0.1|||ANOVA|||||0.1|-0.3|0.4274
71739000|NCT00620113|142990737|SUPERIORITY_OR_OTHER||Difference in LS Means|-28.86|||<|0.001|TWO_SIDED|95.0|-44.97|-12.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||-12.75|-44.97|<0.001
71739001|NCT00620113|142990737|SUPERIORITY_OR_OTHER||Difference in LS Means|-5.61||||0.458|TWO_SIDED|95.0|-23.79|12.56||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.||12.56|-23.79|0.458
71739002|NCT01979133|142990751|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||.012
71739003|NCT01979133|142990752|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.005
71739004|NCT01979133|142990753|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.017
71739005|NCT01979133|142990754|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.038
71739006|NCT01979133|142990755|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.034
71739007|NCT01979133|142990756|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.231
71739008|NCT01979133|142990757|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.066
71739009|NCT00486824|142990758|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71739010|NCT00931606|142990810|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739011|NCT00931606|142990810|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739012|NCT00931606|142990810|SUPERIORITY|||||||0.524|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.524
71888873|NCT02939131|143298762|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.05|TWO_SIDED|95.0|0.0|4.4|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group had more days with missed depression medications than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 24.||4.4|0.0|0.05
71739013|NCT00931606|142990810|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739014|NCT00931606|142990810|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71739015|NCT00931606|142990810|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71739016|NCT00931606|142990810|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71739017|NCT00931606|142990810|SUPERIORITY|||||||0.236|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.236
71739018|NCT00931606|142990810|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
71739019|NCT00931606|142990810|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
71739020|NCT00931606|142990813|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739021|NCT00931606|142990813|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739022|NCT00931606|142990813|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71739023|NCT00931606|142990813|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71739024|NCT00931606|142990814|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739025|NCT00931606|142990814|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739026|NCT00931606|142990814|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
71739027|NCT00931606|142990814|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739028|NCT00931606|142990814|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71739029|NCT00931606|142990814|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71739030|NCT00931606|142990814|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999, are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71739031|NCT00931606|142990814|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
71739032|NCT00931606|142990814|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71771717|NCT00396032|143043700|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||Chi-squared|||||||0.0035
71729805|NCT05320393|142974214|OTHER|This study was not powered for formal hypothesis testing; analyses were intended for interpretation purposes only. Analysis was performed using the modified Intent-to-Treat population and regardless of responder status.||||||0.0109|TWO_SIDED|95.0|||||Log Rank|||The primary effectiveness endpoint was a measure of duration of effect, described by Kaplan-Meier curves and the median times, with associated 2-sided 95% confidence intervals for each treatment group.||||0.0109
71729806|NCT05693922|142974215|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
71729807|NCT05693922|142974216|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
71729808|NCT05693922|142974217|SUPERIORITY|||||||0.865|||||||ANOVA|||||||0.865
71729809|NCT03559699|142974233|OTHER|||||||0.0002|TWO_SIDED|95.0||||1-sided P-value|Binomial exact test|||||||0.0002
71729810|NCT02091284|142974281|OTHER||||||<|0.01||||||Two-way ANOVA with repeated measures followed by Bonferroni's multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group.|ANOVA|||||||< 0.01
71729811|NCT02091284|142974281|OTHER||||||<|0.05|||||||t-test, 2 sided|||Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests.||||<0.05
71729812|NCT01460719|142974315|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the GMFR is \>1.0.|||||<|0.001|||||||Single longitudinal regression model|Adjustments made for pre-vaccination values||||||<0.001
71729813|NCT02838901|142974322|OTHER|This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.||||||0.058||||||The p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.||||0.058
71729814|NCT02838901|142974323|OTHER|This was a descriptive analysis and was under the goal of assessing safety of the intervention.||||||1|||||||Fisher Exact|||Null hypothesis was assumed, no power calculation was done since this was a pilot study.||||1.00
71729815|NCT02838901|142974324|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.||||0.0003
71729816|NCT02838901|142974325|OTHER|This was a descriptive analysis for a pilot study, and no power calculations were performed.||||||0.1023|||||||Wilcoxon (Mann-Whitney)|||||||0.1023
71729817|NCT02838901|142974326|OTHER|This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||||||.9581
71729818|NCT02838901|142974326|OTHER|||||||0.6678|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.||||.6678
71729819|NCT02838901|142974328|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71729820|NCT02838901|142974328|OTHER|||||||0.876|||||||Wilcoxon (Mann-Whitney)|||||||.876
71729821|NCT02838901|142974329|OTHER|||||||0.889|||||||Wilcoxon (Mann-Whitney)|||||||.889
71729822|NCT02838901|142974329|OTHER|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||||||0.532
71729823|NCT02838901|142974330|OTHER|||||||0.888|||||||Wilcoxon (Mann-Whitney)|||||||0.888
71729824|NCT02838901|142974331|OTHER|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
71729825|NCT02838901|142974332|OTHER|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||||||0.135
71729826|NCT02838901|142974333|OTHER|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||||||0.185
71729827|NCT03397134|142974363|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals||||||0.043||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||To evaluate the efficacy of 2 fixed doses (32 mg and 64 mg) of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the PANSS Marder negative symptoms factor score (NSFS) over 12 weeks of double-blind treatment. Approximation 501 eligible patients will be randomized in a 2:2:1:1 ratio at baseline to 1 of 4 treatment arms.||||0.043
71729828|NCT03397134|142974364|SUPERIORITY|All statistical tests will be 2-sided hypothesis tests performed at the 5% level of significance. All confidence intervals will be 2-sided 95% confidence intervals.||||||0.016||||||The p-values must be ≤0.025 to allow for rejecting the null hypothesis for the representative dose.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||The PSP involves four subscale domains: (a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. After each of these four areas is scored on an anchored Likert-type scale (0-5), raters are instructed to select a 10-point range within a 100-point scale, guided by the area scores assigned during assessment.||||0.016
71729829|NCT02370004|142974427|OTHER|||||||0.1|||||||t-test, 2 sided|||Paired T-tests were used to evaluate changes in spirometry results||||.10
71729830|NCT02963987|142974439|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71729831|NCT02963987|142974440|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71729832|NCT02963987|142974441|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71729833|NCT02266277|142974459|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.3||||0.0001|TWO_SIDED|95.0|1.15|1.47||Adjusted for age, sex, race and utilization|Regression, Logistic|||||1.47|1.15|0.0001
71739033|NCT00931606|142990814|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
71729834|NCT02266277|142974459|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.2||||0.0026|TWO_SIDED|95.0|1.07|1.36|||Regression, Logistic|||||1.36|1.07|.0026
71729835|NCT02266277|142974459|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.16||||0.0206|TWO_SIDED|95.0|1.02|1.31|||Regression, Logistic|||||1.31|1.02|.0206
71729836|NCT02266277|142974459|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.07||||0.233|TWO_SIDED|95.0|0.96|1.21|||Regression, Logistic|||||1.21|.96|.2330
71729837|NCT02266277|142974459|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio, log|1.12||||0.0579|TWO_SIDED|95.0|0.996|1.26|||Regression, Logistic|||||1.26|.996|.0579
71729838|NCT02266277|142974459|SUPERIORITY|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.14|||Regression, Logistic|||||1.14|.86|.87
71888874|NCT02939131|143298762|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.53|TWO_SIDED|95.0|-12.5|7.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported more days with missed doses than those in the ESC group.|Comparison of COMB-R and ESC groups, number of days in last 30 with any missed depression medication doses reported at week 48.||7.1|-12.5|0.53
71729839|NCT02266277|142974460|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.31|||Regression, Logistic|||||1.31|.81|.82
71729840|NCT02266277|142974460|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio, log|0.9||||0.36|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.36
71729841|NCT02266277|142974460|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.89||||0.33|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic|||||1.13|.71|.33
71729842|NCT02266277|142974460|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.87||||0.23|TWO_SIDED|95.0|0.69|1.09|||Regression, Logistic|||||1.09|.69|.23
71729843|NCT02266277|142974460|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.99||||0.96|TWO_SIDED|95.0|0.79|1.25|||Regression, Logistic|||||1.25|.79|.96
71729844|NCT02266277|142974460|SUPERIORITY|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Logistic|||||1.31|.82|.76
71729845|NCT02498067|142974485|OTHER|||||||0.177||||||a priori threshold for statistical significance: p\<0.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.177
71729846|NCT02498067|142974486|OTHER|||||||0.318||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.318
71888875|NCT02939131|143298763|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.13|TWO_SIDED|95.0|-1.5|0.2|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 24.||0.2|-1.5|0.13
71771718|NCT00396032|143043702|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||Stratified by baseline BFR: 0-199 mL/min, 200-274 mL/min, and 275-299 mL/min.|Cochran-Mantel-Haenszel|||||||0.0396
71729847|NCT02498067|142974487|OTHER|||||||0||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)||||.000
71771719|NCT00076024|143043708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.237||||0.156|TWO_SIDED|95.0|0.819|1.867|||Log Rank|One-sided log-rank test at alpha = 0.1 significance level was used.||P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.||1.867|0.819|0.156
71729848|NCT02498067|142974489|OTHER|||||||0.03||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.030
71729849|NCT02498067|142974490|OTHER|||||||0.14||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.140
71729850|NCT02498067|142974491|OTHER|||||||0.315||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app||||.315
71729851|NCT02498067|142974492|OTHER|||||||0.028||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.028
71729852|NCT02498067|142974493|OTHER|||||||0.918||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan||||.918
71729853|NCT02498067|142974495|OTHER|||||||0.209||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-up||||.209
71771720|NCT00076024|143043709|SUPERIORITY_OR_OTHER||Difference in response rates|17.4||||0.038|TWO_SIDED|95.0|3.0|31.9|||Fisher Exact|||||31.9|3.0|0.038
71831190|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0651|TWO_SIDED|95.0|0.99|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.44|0.99|0.0651
71831191|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9032|TWO_SIDED|95.0|0.84|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=30% reduction||1.22|0.84|0.9032
71888876|NCT02939131|143298763|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.53|TWO_SIDED|95.0|-1.1|2.0|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group were better at taking their medications.|Comparison of COMB-R and ESC groups, how good was participant at taking depression medication; reported at week 48.||2.0|-1.1|0.53
71729854|NCT02498067|142974496|OTHER|||||||0.652||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.652
71729855|NCT02498067|142974497|OTHER|||||||0.498||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan||||.498
71729856|NCT02498067|142974498|OTHER|||||||0.977||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.977
71729857|NCT02498067|142974499|OTHER|||||||0.673||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan||||.673
71729858|NCT02498067|142974500|OTHER|||||||0.049||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.049
71771721|NCT03981822|143043714|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0048
71771722|NCT03981822|143043714|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Part B summary is pooled with its respective treatments from Part A.||||0.0075
71771723|NCT03981822|143043715|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.||||0.3642
71771724|NCT03981822|143043715|SUPERIORITY|||||||0.0967||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0967
71771725|NCT03981822|143043715|SUPERIORITY|||||||0.0648||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0648
71729859|NCT02498067|142974500|OTHER|||||||0.265||||||a priori threshold for statistical significance: p\<.05|t-test, 2 sided|||Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlan||||.265
71729860|NCT00747344|142974506|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. With 120 subjects (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight (\<=65kg vs \> 65 kg). For all the scenarios evaluated, the power was \> 99% at a significance level of 0.05.||||<0.001
71831192|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.36||||0.01|TWO_SIDED|95.0|1.08|1.72|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.72|1.08|0.0100
71831193|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.12||||0.3728|TWO_SIDED|95.0|0.88|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=50% reduction||1.42|0.88|0.3728
71831194|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0434|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0434
71831195|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0425|TWO_SIDED|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=70% reduction||2.04|1.01|0.0425
71831196|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5442|TWO_SIDED|95.0|0.64|2.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||2.34|0.64|0.5442
71831197|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0349|TWO_SIDED|95.0|1.05|3.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: \>=90% reduction||3.45|1.05|0.0349
71739034|NCT00931606|142990814|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
71739035|NCT00931606|142990815|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739036|NCT00931606|142990815|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739037|NCT00931606|142990815|SUPERIORITY|||||||0.206|||||||Fisher Exact|Clopper and Pearson exact approach||Overall||||0.206
71739038|NCT00931606|142990815|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Overall||||>0.999
71739039|NCT00931606|142990815|SUPERIORITY|||||||0.333|||||||Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||0.333
71739040|NCT00931606|142990815|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71739041|NCT00931606|142990815|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Weekly Chemotherapy||||>0.999
71739042|NCT00931606|142990815|SUPERIORITY|||||||0.429|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.429
71739043|NCT00931606|142990815|SUPERIORITY||||||>|0.999||||||"P-values greater than 0.999 are reported as \>0.999."|Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||>0.999
71739044|NCT00931606|142990815|SUPERIORITY|||||||0.143|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.143
71739045|NCT00931606|142990815|SUPERIORITY|||||||0.519|||||||Fisher Exact|Clopper and Pearson exact approach||Less Frequent Chemotherapy||||0.519
71739046|NCT00125957|142990852|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||.04
71739047|NCT00125957|142990853|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups||||0.09
71739048|NCT03688074|142990872|OTHER||Ratio of Geometric LSMeans|0.15|||<|0.001|TWO_SIDED|90.0|0.06|0.35||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter : Eosinophils (cells/mm\^2)||95% CI (0.05, 0.41)|0.35|0.06|<0.001
71739049|NCT03688074|142990872|OTHER||Ratio of Geometric LSMeans|1.36||||0.106|TWO_SIDED|90.0|0.99|1.86||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Neutrophils (cells/mm\^2)||95% CI (0.94, 1.97)|1.86|0.99|0.106
71739050|NCT03688074|142990872|OTHER||Ratio of Geometric LSMeans|1.12||||0.389|TWO_SIDED|90.0|0.9|1.4||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD3+ (cells/mm\^2)||95% CI (0.86, 1.46)|1.40|0.90|0.389
71771726|NCT03981822|143043715|SUPERIORITY|||||||0.1357||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.1357
71771727|NCT03981822|143043715|SUPERIORITY|||||||0.019||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0190
71771728|NCT03981822|143043715|SUPERIORITY|||||||0.0184||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
71771729|NCT03981822|143043715|SUPERIORITY|||||||0.0048||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0048
71771730|NCT03981822|143043715|SUPERIORITY|||||||0.0075||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.||||0.0075
71729861|NCT00747344|142974507|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs \> 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
71729862|NCT00747344|142974508|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
71729863|NCT00765882|142974509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93||||0.0012|TWO_SIDED|95.0|1.5|5.72||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 90% based on study NCT00402337 (MCP-103-201) data."||5.72|1.50|0.0012
71771731|NCT03981822|143043715|SUPERIORITY|||||||0.0539||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.0539
71771732|NCT03981822|143043715|SUPERIORITY|||||||0.1638||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.||||0.1638
71771733|NCT03981822|143043715|SUPERIORITY|||||||0.4766||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.4766
71771734|NCT03981822|143043715|SUPERIORITY|||||||0.1588||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.||||0.1588
71771735|NCT03981822|143043716|SUPERIORITY|||||||0.3642||||||P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.|Cochran-Mantel-Haenszel|||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.3642
71831198|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0108|TWO_SIDED|95.0|1.05|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.51|1.05|0.0108
71888877|NCT02939131|143298764|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 24.||0.1|-1.3|0.07
71729864|NCT00765882|142974509|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.22|||<|0.0001|TWO_SIDED|95.0|2.2|8.1||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 96% based on study NCT00460811 (MCP-103-202) data."||8.10|2.20|<0.0001
71729865|NCT02337530|142974517|SUPERIORITY||Odds Ratio (OR)|1.37||||0.73|TWO_SIDED|95.0|0.28|7.01|||Fisher Exact|||||7.01|0.28|0.73
71771736|NCT03981822|143043716|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.0356
71771737|NCT03981822|143043716|SUPERIORITY|||||||0.0118|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0118
71771738|NCT03981822|143043716|SUPERIORITY|||||||0.0026||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.||||0.0026
71771739|NCT03981822|143043716|SUPERIORITY|||||||0.0174|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.0174
71771740|NCT03981822|143043716|SUPERIORITY|||||||0.1311|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1311
71771741|NCT03981822|143043716|SUPERIORITY|||||||0.0967|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.||||0.0967
71771742|NCT03981822|143043716|SUPERIORITY|||||||0.1357|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.||||0.1357
71771743|NCT03981822|143043716|SUPERIORITY|||||||0.0184|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.||||0.0184
71771744|NCT03981822|143043716|SUPERIORITY|||||||0.0024|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.||||0.0024
71831199|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.27||||0.008|TWO_SIDED|95.0|1.07|1.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=30% reduction||1.52|1.07|0.0080
71831200|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.22|1.83|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.83|1.22|<0.0001
71729866|NCT02337530|142974517|SUPERIORITY||Odds Ratio (OR)|6.4||||0.01|TWO_SIDED|95.0|1.65|24.8|||Fisher Exact|||||24.8|1.65|0.01
71888878|NCT02939131|143298764|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.28|TWO_SIDED|95.0|-0.8|2.3|||t-test, 2 sided||A positive difference would indicate those in the COMB-R group reported better adherence than those in the ESC group.|Comparison of COMB-R and ESC groups, how often did participant take depression medication as instructed; reported at week 48.||2.3|-0.8|0.28
71729867|NCT02337530|142974518|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.56|TWO_SIDED|95.0|0.42|1.6|||Log Rank|||||1.60|0.42|0.56
71729868|NCT02337530|142974518|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.44|TWO_SIDED|95.0|0.4|1.49|||Log Rank|||||1.49|0.40|0.44
71729869|NCT01945775|142974612|SUPERIORITY||Hazard Ratio, log|0.542|||<|0.0001|TWO_SIDED|95.0|0.413|0.711|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.711|0.413|<0.0001
71729870|NCT01945775|142974613|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.93|8.83|||Cochran-Mantel-Haenszel|||p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.||8.83|2.93|<0.0001
71729871|NCT01945775|142974614|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.1693|TWO_SIDED|95.0|0.67|1.073|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||1.073|0.670|0.1693
71729872|NCT01945775|142974622|SUPERIORITY||Mean Difference (Final Values)|8.4|||<|0.0001|TWO_SIDED|95.0|4.6|12.3|||Mixed Models Analysis|||Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.||12.3|4.6|<0.0001
71729873|NCT01945775|142974623|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.257|0.549|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).||0.549|0.257|<0.0001
71729874|NCT01945775|142974624|SUPERIORITY||Hazard Ratio (HR)|0.392||||0.0053|TWO_SIDED|95.0|0.198|0.775|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).||0.775|0.198|0.0053
71729875|NCT02876328|142974625|SUPERIORITY||||||<|0.001||||||Each active group is compared to placebo using a 2-sided .0167 significance level.|Cochran-Mantel-Haenszel|Analyses are stratified by site.||Analysis applies to both adults and children.||||<.001
71729876|NCT00334282|142974635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||1e-07||95.0|0.34|0.62||stratified log-rank test|Log Rank||The estimated value is the hazard ratio comparing pazopanib to placebo.|||0.62|0.34|.0000001
71729877|NCT01689350|142974646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.99|||<|0.01|TWO_SIDED|95.0|1.76|14.14|||Chi-squared|||Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.||14.14|1.76|<0.01
71729878|NCT01689350|142974647|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.05|TWO_SIDED|95.0|1.01|7.13|||Chi-squared|||||7.13|1.01|<0.05
71729879|NCT00085254|142974657|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4|TWO_SIDED|95.0|0.5|1.3|||Regression, Cox|||||1.3|0.5|0.4
71729880|NCT00085254|142974659|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0001|TWO_SIDED|95.0|0.3|0.5||adjusted for age: p=.0003, kps: p=.004; and surgical procedure: p=.003|Log Rank|||Primary endpoint death - defined from histological diagnosis to death. we assume pt in the study will have overall failure rate of 0.56 per person-year of f/up, a 30% reduction compared to hazard rate of 0.8 per person-year in historical NABTT database. Expected hazard ratio is 0.7 and cohort will produce 63 events among total of 94 pt planned f/up. One-sided test, have 95% power to detect observed ratio of 0.7 at alpha level of 0.1, or we have 88% power at alpha of 0.5 statistical significant||0.5|0.3|0.0001
71729881|NCT04342689|142974660|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||0.99
71729882|NCT04342689|142974661|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71729883|NCT04342689|142974662|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71729884|NCT01460407|142974663|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.28|||||TWO_SIDED|90.0|1.16|1.42|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.42|1.16|
71729885|NCT01460407|142974664|SUPERIORITY_OR_OTHER||Ratio of geometric LS mean|1.21|||||TWO_SIDED|90.0|1.12|1.31|||||Ratio of LY2216684 and Clarithromycin to LY2216684|||1.31|1.12|
71729886|NCT01460407|142974665|SUPERIORITY_OR_OTHER||Median of paired differences|0.0||||0.7656|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||LY2216684 and Clarithromycin minus (-) LY2216684|||0.50|-0.50|0.7656
71729887|NCT00844805|142974685|SUPERIORITY_OR_OTHER||Difference in Percentages|14.9|||=|0.0884|TWO_SIDED|95.0|-1.7|31.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.5|-1.7|=0.0884
71729888|NCT00844805|142974686|SUPERIORITY_OR_OTHER||Difference in Percentages|21.7|||=|0.0013|TWO_SIDED|95.0|11.0|32.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||32.5|11.0|=0.0013
71729889|NCT00844805|142974687|SUPERIORITY_OR_OTHER||Difference in Percentages|18.1|||=|0.0004|TWO_SIDED|95.0|10.7|25.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||25.5|10.7|=0.0004
71729890|NCT00844805|142974688|SUPERIORITY_OR_OTHER||Difference in Percentages|10.0|||=|0.5005|TWO_SIDED|95.0|-11.7|31.7|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||31.7|-11.7|=0.5005
71831201|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.24|1.85|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=50% reduction||1.85|1.24|<0.0001
71831202|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.45||||0.006|TWO_SIDED|95.0|1.11|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.88|1.11|0.0060
71831203|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0031|TWO_SIDED|95.0|1.14|1.93|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=70% reduction||1.93|1.14|0.0031
71831204|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0235|TWO_SIDED|95.0|1.08|2.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||2.88|1.08|0.0235
71729891|NCT00844805|142974689|SUPERIORITY_OR_OTHER||Difference in Percentages|-2.5|||=|1|TWO_SIDED|95.0|-14.9|9.9|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||9.9|-14.9|=1.0000
71729892|NCT00844805|142974690|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||=|1|TWO_SIDED|95.0|-6.8|6.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||6.8|-6.8|=1.0000
71831205|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0021|TWO_SIDED|95.0|1.31|3.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: \>=90% reduction||3.42|1.31|0.0021
71831206|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7613|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.23|0.86|0.7613
71888879|NCT02939131|143298765|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.44|TWO_SIDED|95.0|-0.6|0.3|||t-test, 2 sided|||||0.3|-0.6|0.44
71729893|NCT00844805|142974691|SUPERIORITY_OR_OTHER||||||=|0.3802||95.0|||||Log Rank|||||||=0.3802
71729894|NCT00844805|142974692|SUPERIORITY_OR_OTHER||Difference in Percentages|-5.0|||=|0.6153|TWO_SIDED|95.0|-14.5|4.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||4.5|-14.5|=0.6153
71729895|NCT00844805|142974693|SUPERIORITY_OR_OTHER||Difference in Percentages|18.4|||=|0.0263|TWO_SIDED|95.0|2.5|34.3|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||34.3|2.5|=0.0263
71729896|NCT00844805|142974694|SUPERIORITY_OR_OTHER||Difference in Percentages|8.4|||=|0.3011|TWO_SIDED|95.0|-6.0|22.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.|||22.8|-6.0|=0.3011
71729897|NCT01741532|142974731|SUPERIORITY|||||||0.0761|||||||Mixed Models Analysis|||||||0.0761
71729898|NCT01741532|142974732|SUPERIORITY|||||||0.7279|||||||Mixed Models Analysis|||||||0.7279
71729899|NCT01741532|142974733|SUPERIORITY|||||||0.7228|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part I||||0.7228
71729900|NCT01741532|142974733|SUPERIORITY|||||||0.3677|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part II||||0.3677
71729901|NCT01741532|142974733|SUPERIORITY|||||||0.2182|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part III||||0.2182
71729902|NCT01741532|142974733|SUPERIORITY|||||||0.1749|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part VI||||0.1749
71729903|NCT01741532|142974734|SUPERIORITY|||||||0.1524|||||||Mixed Models Analysis|||||||0.1524
71729904|NCT01741532|142974735|SUPERIORITY|||||||0.2026|||||||Mixed Models Analysis|||||||0.2026
71729905|NCT01741532|142974736|SUPERIORITY|||||||0.9759|||||||Mixed Models Analysis|||Patient self-report, total score||||0.9759
71729906|NCT01741532|142974736|SUPERIORITY|||||||0.5781|||||||Mixed Models Analysis|||Parent proxy-report, total score||||0.5781
71729907|NCT01741532|142974737|SUPERIORITY|||||||0.6323|||||||Mixed Models Analysis|||||||0.6323
71729908|NCT01741532|142974738|SUPERIORITY|||||||0|||||||Mixed Models Analysis|||||||0.0000
71729909|NCT01498185|142974752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|18.5425|||TWO_SIDED|95.0|-40.85|35.86||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||35.86|-40.85|
71729910|NCT01498185|142974752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|16.7228|||TWO_SIDED|95.0|-35.36|33.82||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||33.82|-35.36|
71729911|NCT01498185|142974752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.88|STANDARD_ERROR_OF_MEAN|17.1548|||TWO_SIDED|95.0|-42.21|28.45||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||28.45|-42.21|
71729912|NCT01498185|142974752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|18.4617|||TWO_SIDED|95.0|-39.22|37.16||No formal statistical testing was performed to compare between treatment groups.|Descriptive statistics|||||37.16|-39.22|
71729913|NCT00946322|142974760|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.028
71729914|NCT00946322|142974761|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.||||.022
71729915|NCT00946322|142974762|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.043
71729916|NCT00946322|142974763|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.482
71729917|NCT00946322|142974764|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.009
71729918|NCT00946322|142974765|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.001
71729919|NCT00946322|142974766|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.027
71729920|NCT00946322|142974767|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|||Paired sample t-test||||.177
71729921|NCT01822535|142974805|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.||||<0.01
71729922|NCT01822535|142974806|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.018
71771745|NCT03981822|143043716|SUPERIORITY|||||||0.1034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.||||0.1034
71771746|NCT03981822|143043716|SUPERIORITY|||||||0.1029|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.||||0.1029
71771747|NCT03981822|143043717|SUPERIORITY|||||||0.0356|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0356
71771748|NCT03981822|143043717|SUPERIORITY|||||||0.1477|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.1477
71888880|NCT02939131|143298767|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||The average number of scheduled study visits through week 24 was computed for each site. The analysis was of these site-level averages. These values were compared between study groups||0.3|-0.4|0.67
71729923|NCT01822535|142974807|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||ANOVA|||"Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."||||0.0431
71729924|NCT01822535|142974808|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||"We hypothesized that administration of midodrine would attenuate the fall in core body temperature.~Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug)."||||0.30
71729925|NCT01071356|142974809|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|-0.006||||0.47|TWO_SIDED|95.0|-0.023|0.011|||Random Effects modeling||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.011|-.023|.47
71729926|NCT01071356|142974810|SUPERIORITY_OR_OTHER||Time averaged post-bline diff in diff|0.007||||0.034|TWO_SIDED|95.0|0.001|0.013|||Random effects model||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.||.013|.001|.034
71729927|NCT02278614|142974811|OTHER|The change from baseline in mean IOP on Day 84 for the contralateral eye,|Adjusted mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.57|0.43|||Mixed Models Analysis|||||0.43|-0.57|
71729928|NCT02278614|142974811|OTHER|The change from baseline in mean IOP on D42 for the worse eye|Adjusted mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-0.69|0.31|||Mixed Models Analysis|||||0.31|-0.69|
71729929|NCT03582813|142974823|SUPERIORITY||MIXREG Estimate|4.27|STANDARD_ERROR_OF_MEAN|1.61|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime;||||<.01
71729930|NCT03582813|142974824|SUPERIORITY||MIXREG Estimate|0.9|STANDARD_ERROR_OF_MEAN|0.42||0.031|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-esteem that would be maintained longitudinally||||.031
71729931|NCT03582813|142974825|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in coping mastery that would be maintained longitudinally||||<0.01
71729932|NCT03582813|142974826|SUPERIORITY||MIXREG Estimate|0.29|STANDARD_ERROR_OF_MEAN|0.13||0.03|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in perceived autonomy support that would be maintained longitudinally||||0.030
71729933|NCT03582813|142974827|SUPERIORITY||Odds Ratio (OR)|2.19||||0.046|TWO_SIDED|95.0|1.01|4.74|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of employment that would be maintained longitudinally||4.74|1.01|0.046
71729934|NCT03582813|142974828|SUPERIORITY||Odds Ratio (OR)|4.14|||<|0.01|TWO_SIDED|95.0|1.5|11.44|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of enrollment in educational classes that would be maintained longitudinally||11.44|1.50|<0.01
71729935|NCT02558400|142974838|SUPERIORITY|To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints|||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil||||||<0.0001
71729936|NCT02558400|142974838|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost||||||<0.0001
71729937|NCT02230683|142974840|SUPERIORITY_OR_OTHER||within group change|-1.14|STANDARD_DEVIATION|4.57||0.257|TWO_SIDED|95.0|-3.16|0.89|||Paired t-test||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||0.89|-3.16|0.257
71729938|NCT02230683|142974840|SUPERIORITY_OR_OTHER||within group change|1.9|STANDARD_DEVIATION|3.15||0.1174|TWO_SIDED|95.0|-0.52|4.32|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup||4.32|-0.52|0.1174
71729939|NCT02230683|142974840|SUPERIORITY_OR_OTHER||within group change|-3.67|STANDARD_DEVIATION|4.05||0.0025|TWO_SIDED|95.0|-5.88|-1.46|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup||-1.46|-5.88|0.0025
71729940|NCT02230683|142974841|SUPERIORITY_OR_OTHER||within group change|-0.22||||0.026|TWO_SIDED|95.0|-0.42|-0.03|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||-0.03|-0.42|0.026
71729941|NCT02230683|142974841|SUPERIORITY_OR_OTHER||within group change|-0.46||||0.001|TWO_SIDED|95.0|-0.72|-0.21|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-0.21|-0.72|0.001
71729942|NCT02230683|142974841|SUPERIORITY_OR_OTHER||within group change|-0.04||||0.72|TWO_SIDED|95.0|-0.26|0.18|||ANCOVA|||Statistical Analysis for the median change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||0.18|-0.26|0.72
71771749|NCT03981822|143043717|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0062
71771750|NCT03981822|143043717|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0046
71771751|NCT03981822|143043717|SUPERIORITY|||||||0.0177|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0177
71771752|NCT03981822|143043717|SUPERIORITY|||||||0.0054|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0054
71729943|NCT02230683|142974842|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-21.0||||0.105|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily||13|-60|0.105
71729944|NCT02230683|142974842|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-52.5||||0.016|TWO_SIDED|95.0|-109.0|-6.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG \< 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||-6|-109|0.016
71729945|NCT02230683|142974842|SUPERIORITY_OR_OTHER||Hodges-Lehmann|12.0||||0.839|TWO_SIDED|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily||13|-60|0.839
71729946|NCT02230683|142974843|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0084|TWO_SIDED|95.0|-7.0|0.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Alanine Aminotransferase (ALT) from Baseline to Day 28/EOT||0|-7|0.0084
71729947|NCT02230683|142974844|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-4.0||||0.0131|TWO_SIDED|95.0|-7.0|-1.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Aspartate Aminotransferase (AST) from Baseline to Day 28/EOT||-1|-7|0.0131
71729948|NCT02230683|142974845|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-772.0||||0.003|TWO_SIDED|95.0|-1188.0|-19.0|||Wilcoxon (Mann-Whitney)||The estimated value is the ratio for the difference from baseline.|Statistical Analysis for the median change in concentration of Caspase 3/7 Relative Light Units from baseline to Day 28/EOT||-19|-1188|0.003
71729949|NCT00260065|142974846|SUPERIORITY_OR_OTHER||Percentage of Participants|33.0||||||95.0|24.2|43.5||||||||43.5|24.2|
71729950|NCT00260065|142974847|SUPERIORITY_OR_OTHER||Percentage of Participants|52.0||||||95.0|41.3|61.7||||||||61.7|41.3|
71729951|NCT01151761|142974892|SUPERIORITY_OR_OTHER||months|8.5|||||TWO_SIDED|95.0|7.0|10.0|||||There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.|The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.||10|7|
71729952|NCT01151761|142974897|SUPERIORITY_OR_OTHER||proportion of participants|0.0|||||TWO_SIDED||||||||None of the two patients who participated had a local recurrence before they died.|||||
71729953|NCT05257148|142974902|SUPERIORITY||Mean Difference (Final Values)|-9.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71729954|NCT03554772|142974928|SUPERIORITY||||||<|0.0001||||||p-value for each dose group vs placebo comparison|ANCOVA|ANCOVA model included treatment as main effect , baseline NPRS and basline BMI as covariates P-value is Dunnett adjusted (individual treatment arms)||||||<0.0001
71729955|NCT00241631|142974984|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
71729956|NCT00241631|142974985|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
71729957|NCT00241631|142974986|SUPERIORITY||||||<|0.05||||||calculated|Mixed Models Analysis|||||||<0.05
71729958|NCT03883113|142974987|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
71729959|NCT03883113|142974987|OTHER|||||||0.1654|||||||Wilcoxon (Mann-Whitney)|||||||0.1654
71729960|NCT03883113|142974987|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||||||0.1711
71831207|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0548|TWO_SIDED|95.0|1.0|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=30% reduction||1.43|1.00|0.0548
71831208|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0196|TWO_SIDED|95.0|1.04|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.51|1.04|0.0196
71831209|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.2|1.75|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=50% reduction||1.75|1.20|<0.0001
71831210|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0077||95.0|1.09|1.77|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||1.77|1.09|0.0077
71729961|NCT03883113|142974988|OTHER|||||||1|||||||Fisher Exact|||The statistical analysis applies to participants with Virologically confirmed Influenza-like Illness versus participants without Virologically confirmed Influenza-like Illness||||1.000
71729962|NCT03883113|142974989|OTHER|||||||0.143|||||||Fisher Exact|||This statistical analysis applies to participants with qPCR confirmed Influenza versus participants with no qPCR confirmed Influenza||||0.143
71729963|NCT03883113|142974990|OTHER|||||||0.3504|||||||Fisher Exact|||This statistical analysis applies to participants with qCulture confirmed Influenza versus participants without qCulture confirmed Influenza||||0.3504
71729964|NCT03883113|142974991|OTHER|||||||0.5558|||||||Log Rank|||||||0.5558
71729965|NCT03883113|142974992|OTHER|||||||0.6534|||||||Log Rank|||||||0.6534
71729966|NCT03883113|142974993|OTHER|||||||0.5485|||||||Wilcoxon (Mann-Whitney)|||||||0.5485
71729967|NCT03883113|142974994|OTHER|||||||0.6753|||||||Wilcoxon (Mann-Whitney)|||||||0.6753
71729968|NCT03883113|142974995|OTHER|||||||0.711|||||||Log Rank|||||||0.711
71729969|NCT03883113|142974996|OTHER|||||||0.4689|||||||Log Rank|||||||0.4689
71729970|NCT03883113|142974999|OTHER|||||||0.5001|||||||Wilcoxon (Mann-Whitney)|||||||0.5001
71729971|NCT03883113|142975000|OTHER|||||||0.6799|||||||zero-inflated poisson model|||||||0.6799
71729972|NCT03883113|142975001|OTHER|||||||0.5911|||||||Wilcoxon (Mann-Whitney)|||||||0.5911
71729973|NCT03523273|142975015|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71729974|NCT03523273|142975016|SUPERIORITY|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
71729975|NCT01457950|142975029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.06|4.36|||ANCOVA|||||4.36|2.06|<0.0001
71729976|NCT00435162|142975066|SUPERIORITY_OR_OTHER||Slope|-1.05||||0.099|TWO_SIDED|95.0|-2.31|0.2|||Regression, Linear|||Slope change across all 3 active treatment groups.||0.20|-2.31|0.0990
71729977|NCT03249935|142975092|SUPERIORITY|||||||||||||||||Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.|Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.|||
71729978|NCT03249935|142975093|SUPERIORITY||Odds Ratio (OR)|0.75||||0.656|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic|||Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28||2.62|0.22|0.656
71729979|NCT03249935|142975093|SUPERIORITY||Odds Ratio (OR)|4.65||||0.197|TWO_SIDED|95.0|0.45|47.89|||Regression, Logistic|||Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.||47.89|0.45|0.197
71729980|NCT03249935|142975093|SUPERIORITY||Odds Ratio (OR)|0.68||||0.058|TWO_SIDED|95.0|0.45|1.01|||Regression, Logistic|||Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.||1.01|0.45|0.058
71729981|NCT01229943|142975094|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.12|TWO_SIDED|95.0|0.55|1.17||Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).|Log Rank|||Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).||1.17|0.55|0.12
71729982|NCT01669421|142975126|OTHER|Data was analyzed with multiple repeat ANOVA for all visits and paired samples were also evaluated.|||||<|0.05|||||||Kruskal-Wallis|||IL-2||||<0.05
71729983|NCT01669421|142975126|OTHER|Kruskal-Wallis||||||0.035|||||||Kruskal-Wallis|||IL-4||||0.035
71729984|NCT01669421|142975126|OTHER|||||||0.33|||||||Kruskal-Wallis|||IL-8||||0.33
71729985|NCT01669421|142975126|OTHER|||||||0.68|||||||Kruskal-Wallis|||IL-9||||0.68
71729986|NCT01669421|142975126|OTHER|||||||0.02|||||||Kruskal-Wallis|||IL-17||||0.020
71729987|NCT01669421|142975126|OTHER|||||||0.021|||||||Kruskal-Wallis|||FGF||||0.021
71729988|NCT01669421|142975126|OTHER|||||||0.02|||||||Kruskal-Wallis|||Eotaxin||||0.02
71729989|NCT01669421|142975126|OTHER|||||||0.045|||||||Kruskal-Wallis|||GM-CSF||||0.045
71729990|NCT01669421|142975126|OTHER|||||||0.47|||||||Kruskal-Wallis|||IL15||||0.47
71729991|NCT01669421|142975126|OTHER|||||||0.9|||||||Kruskal-Wallis|||IL-1a||||0.90
71729992|NCT01669421|142975126|OTHER|||||||0.8|||||||Kruskal-Wallis|||IL18||||0.80
71729993|NCT01669421|142975126|OTHER|||||||0.027|||||||Kruskal-Wallis|||M-CSF||||0.027
71729994|NCT01669421|142975127|OTHER|||||||0.07|||||||Kruskal-Wallis|||No power calculation and this is an exploratory pilot analysis We expected cytokines to decrease after subjects receive double dose and a rebound after administering standard dose.||||0.07
71729995|NCT01669421|142975129|OTHER|between Week 4 and Week 8||||||0.03|||||||t-test, 2 sided|||Desmosine (DES) and isodesmosine (IDES) are used as indicator of elastin degradation. Levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry.||||0.03
71729996|NCT01669421|142975129|OTHER|||||||0.33|||||||t-test, 2 sided|||between Week 8 and Week 12||||0.33
71729997|NCT01669421|142975129|OTHER|||||||0.029|||||||Kruskal-Wallis|||between Week 4 and Week 12||||0.029
71729998|NCT02961790|142975163|SUPERIORITY|||||||0.0041|||||||Kruskal-Wallis|||||||0.0041
71729999|NCT02961790|142975163|SUPERIORITY|||||||0.0001|||||||Kruskal-Wallis|||||||0.0001
71730000|NCT02961790|142975164|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
71730001|NCT02961790|142975165|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.||||||<0.0001
71730002|NCT02961790|142975166|SUPERIORITY|||||||0.0174|||||||Kruskal-Wallis|||||||0.0174
71771753|NCT03981822|143043717|SUPERIORITY|||||||0.0013|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.||||0.0013
71771754|NCT03981822|143043717|SUPERIORITY|||||||0.0034|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0034
71771755|NCT03981822|143043717|SUPERIORITY|||||||0.0156|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0156
71771756|NCT03981822|143043717|SUPERIORITY|||||||0.0367|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0367
71771757|NCT03981822|143043717|SUPERIORITY|||||||0.1746|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.1746
71771758|NCT03981822|143043717|SUPERIORITY|||||||0.0123|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH test stratified by gender.||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||||0.0123
71771759|NCT03981822|143043718|SUPERIORITY||LS mean difference|-3.96||||0.0021|TWO_SIDED|95.0|-5.41|-1.24||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-1.24|-5.41|0.0021
71730003|NCT02961790|142975166|SUPERIORITY|||||||0.0279|||||||Kruskal-Wallis|||||||0.0279
71730004|NCT02961790|142975167|SUPERIORITY|||||||0.0011|||||||Kruskal-Wallis|||||||0.0011
71730005|NCT02961790|142975167|SUPERIORITY|||||||0.0025|||||||Kruskal-Wallis|||||||0.0025
71730006|NCT01479595|142975200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.514||||0.005|TWO_SIDED|90.0|-0.811|-0.217|||Mixed Models Analysis|||||-0.217|-0.811|0.005
71730007|NCT02370641|142975211|OTHER||Mean Difference (Final Values)|-4.0||||0.012|TWO_SIDED|||||p\<0.05 is defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Firmicutes abundance between urolithin excretors and non excretors||||0.012
71730008|NCT02370641|142975211|OTHER||Mean Difference (Final Values)|2.6||||0.009|TWO_SIDED|||||p\<0.05 was defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Proteobacteria abundance between urolithin excretors and non excretors||||0.009
71730009|NCT05268744|142975212|SUPERIORITY|Since all outcomes were normally distributed, one-sided paired t-test was used to compare mean pre- and post-treatment scores to see whether post-treatment scores of ABI-S and SRS had improved compared to pre-treatment scores|||||<|0.05|||||||t-test, 1 sided|||Null hypothesis was no improvement in mean ABI-S and SRS scores at the end of the study, compared to baseline||||<0.05
71730010|NCT03906656|142975228|SUPERIORITY||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|8.1||0.0002|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=73). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0002
71730011|NCT03906656|142975228|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|9.7|<|1e-05|TWO_SIDED|||||Adjusted p-values based on Holm-Bonferroni method. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided||Mean difference is for paired data (n=77). This explains the discrepancy between the mean difference and the difference between the KAFO and C-Brace means (n=86 and n=77, respectively).|H0: the mean difference (C-Brace - Baseline) \<= 0.||||<0.00001
71730012|NCT03906656|142975228|SUPERIORITY||Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|6.3|<|1e-05|TWO_SIDED||||||t-test, 2 sided||Mean difference is for paired data (n=86). This explains the discrepancy between the mean difference and the difference between the Baseline and KAFO means (n=102 and n=86, respectively).|KAFO vs. Baseline -- H0: the mean difference (KAFO - Baseline) \<= 0.||||<0.00001
71730013|NCT03906656|142975229|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_DEVIATION|26.3||0.005|TWO_SIDED|||||P-value not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|63.6 degrees of freedom.||H0: the mean difference (C-Brace - KAFO) \<= 0||||0.005
71730014|NCT03906656|142975230|SUPERIORITY|P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|3.7||0.005|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|74.4 degrees of freedom||H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.005
71730015|NCT03906656|142975231|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_DEVIATION|53.6||0.583|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1207.5, effect size r = 0.026, p=0.583.|||0.583
71730016|NCT03906656|142975232|SUPERIORITY||Mean Difference (Final Values)|1.28|STANDARD_DEVIATION|4.37||0.0078|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (SAI - Down)|Wilcoxon Signed Rank Test V=438, effect size r = 0.21, p=0.008|||0.0078
71730017|NCT03906656|142975233|SUPERIORITY||Mean Difference (Final Values)|-3.41|STANDARD_DEVIATION|17.0||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=267, effect size r = 0.32, p=0.002|||0.0020
71730018|NCT03906656|142975234|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.178||0.0023|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0. (Fear of falling - indoors)|Wilcoxon Signed Rank Test V=433, effect size r = 0.33, p=0.002|||0.0023
71730019|NCT03906656|142975234|SUPERIORITY||Mean Difference (Final Values)|-0.973|STANDARD_DEVIATION|3.43||0.0066|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||||Wilcoxon Signed Rank Test V=557.5, effect size r = 0.265, p=0.0066|||0.0066
71730020|NCT03906656|142975235|SUPERIORITY|||||||0.006||||||P-value not adjusted for multiple comparisons|McNemar|||Paired dataset. H0: The probability of fallers wearing C-Brace becoming non-fallers wearing KAFO is the same as the probability of non-fallers wearing C-Brace becoming fallers wearing KAFO.||||0.006
71730021|NCT03906656|142975236|SUPERIORITY||Mean Difference (Final Values)|2.82|STANDARD_DEVIATION|16.4||0.08|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=1325.5, effect size r = 0.181, p=0.08.|||0.08
71730022|NCT03906656|142975237|SUPERIORITY||Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|0.184||0.151|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test||Wilcoxon Signed Rank Test V=1124.5, effect size r = 0.125 p=0.151|H0: the median of the population differences (C-Brace - KAFO) \<= 0||||0.151
71771760|NCT03981822|143043718|SUPERIORITY||LS mean difference|-4.72||||0.015|TWO_SIDED|95.0|-5.95|-0.66|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-0.66|-5.95|0.0150
71771761|NCT03981822|143043718|SUPERIORITY||LS mean difference|-5.31||||0.0011|TWO_SIDED|95.0|-6.54|-1.69||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-1.69|-6.54|0.0011
71771762|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.5||||0.0007|TWO_SIDED|95.0|-8.25|-2.32||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||-2.32|-8.25|0.0007
71771763|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.15||||0.0012|TWO_SIDED|95.0|-7.5|-1.91||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-1.91|-7.50|0.0012
71730023|NCT03906656|142975238|SUPERIORITY|H0: the mean of the population differences (C-Brace - KAFO) \>= 0|Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|21.5||0.281|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|16.7 degrees of freedom||WLQ-25 - Physical||||0.281
71730024|NCT03906656|142975239|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_DEVIATION|5.18||0.00019|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|48.4 degrees of freedom||OPUS - Low Extremity Functional Status. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.00019
71730025|NCT03906656|142975240|SUPERIORITY||Mean Difference (Final Values)|3.19|STANDARD_DEVIATION|15.0||0.0226|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|22.1 degrees of freedom||Emotional well-being. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0226
71730026|NCT03906656|142975240|SUPERIORITY||Mean Difference (Final Values)|6.79|STANDARD_DEVIATION|21.1||0.002|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|||Energy/Fatigue. H0: the mean difference (C-Brace - KAFO) \<= 0.||||0.0020
71730027|NCT03906656|142975240|SUPERIORITY||Mean Difference (Final Values)|10.1|STANDARD_DEVIATION|29.528||0.0049|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Health change. H0: the median of the population differences (C-Brace - KAFO) \<= 0.|Wilcoxon Signed Rank Test. V=649, effect size r = 0.285, p=0.00493|||0.0049
71730028|NCT03906656|142975240|SUPERIORITY||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|29.2||6.47e-05|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|t-test, 2 sided|37.35 degrees of freedom||Physical Functioning Score. H0: the mean difference (C-Brace - KAFO) \<= 0||||0.0000647
71730029|NCT03906656|142975241|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.843||0.301|TWO_SIDED|||||P-values not adjusted for multiple comparisons. P-values \< 0.05 used as threshold for statistical significance.|Wilcoxon Signed Rank Test|||Device. H0: the median of the population differences (C-Brace - KAFO) \<= 0|Wilcoxon Signed Rank Test V=1018.5, effect size r = 0.056, p=0.301|||0.301
71730030|NCT00882908|142975253|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|13.0||||0.051|TWO_SIDED|97.5|-1.9|28.0|||Regression, Logistic||Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.||28.0|-1.9|0.051
71730031|NCT00882908|142975253|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|18.9||||0.004|TWO_SIDED|97.5|4.4|33.5|||Regression, Logistic||Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.||33.5|4.4|0.004
71771764|NCT03981822|143043718|SUPERIORITY||LS mean difference|-5.02||||0.0349|TWO_SIDED|95.0|-6.78|-0.26||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-0.26|-6.78|0.0349
71771765|NCT03981822|143043718|SUPERIORITY||LS mean difference|-4.76|||<|0.0001|TWO_SIDED|95.0|-7.47|-2.85||P-value is based on MMRM mode|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.||-2.85|-7.47|<0.0001
71661165|NCT03786718|142835931|OTHER|||||||0.67|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Blood-glucose Testing sub-scale score||||0.67
71771766|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.0||||0.0005|TWO_SIDED|95.0|-8.37|-2.43||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.||-2.43|-8.37|0.0005
71771767|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.64|||<|0.0001|TWO_SIDED|95.0|-9.65|-4.12||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.||-4.12|-9.65|<0.0001
71771768|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.49||||0.0004|TWO_SIDED|95.0|-9.67|-2.92||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-2.92|-9.67|0.0004
71831211|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.0001|TWO_SIDED|95.0|1.3|2.09|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=70% reduction||2.09|1.30|<0.0001
71831212|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1942|TWO_SIDED|95.0|0.87|1.96|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||1.96|0.87|0.1942
71831213|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0122|TWO_SIDED|95.0|1.11|2.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: \>=90% reduction||2.43|1.11|0.0122
71771769|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.89|-3.57||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.||-3.57|-9.89|<0.0001
71771770|NCT03981822|143043718|SUPERIORITY||LS mean difference|-6.99||||0.0005|TWO_SIDED|95.0|-10.2|-2.94||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-2.94|-10.20|0.0005
71771771|NCT03981822|143043719|SUPERIORITY||LS mean difference|-41.47|||<|0.0001|TWO_SIDED|95.0|-51.31|-20.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-20.87|-51.31|<0.0001
71771772|NCT03981822|143043719|SUPERIORITY||LS mean difference|-50.95||||0.0004|TWO_SIDED|95.0|-66.18|-19.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-19.56|-66.18|0.0004
71771773|NCT03981822|143043719|SUPERIORITY||LS mean difference|-66.21|||<|0.0001|TWO_SIDED|95.0|-88.15|-35.87||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-35.87|-88.15|<0.0001
71661166|NCT03786718|142835931|OTHER|||||||0.65|||||||Wilcoxon Signed Rank Sum test|||Analysis for pre-post change in Foot Care sub-scale score||||0.65
71661167|NCT03786718|142835932|OTHER|||||||0.001|||||||Wilcoxon Signed Rank Sum test|||||||0.001
71661168|NCT03786718|142835933|OTHER|||||||0.86|||||||Wilcoxon Signed Rank Sum test|||||||0.86
71730032|NCT02370095|142975268|SUPERIORITY|||||||0.2416|||||||Wilcoxon (Mann-Whitney)|||Only one placebo subject had data to allow for change from baseline to be calculated||||0.2416
71771774|NCT03981822|143043719|SUPERIORITY||LS mean difference|-79.37|||<|0.0001|TWO_SIDED|95.0|-111.44|-49.77||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-49.77|-111.44|<0.0001
71771775|NCT03981822|143043719|SUPERIORITY||LS mean difference|-69.79||||0.0001|TWO_SIDED|95.0|-103.17|-35.25||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.||-35.25|-103.17|0.0001
71771776|NCT03981822|143043719|SUPERIORITY||LS mean difference|-41.22||||0.1033|TWO_SIDED|95.0|-90.61|8.56||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||8.56|-90.61|0.1033
71771777|NCT03981822|143043719|SUPERIORITY||LS mean difference|-58.43|||<|0.0001|TWO_SIDED|95.0|-73.26|-39.39||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||-39.39|-73.26|<0.0001
71771778|NCT03981822|143043719|SUPERIORITY||LS mean difference|-69.86|||<|0.0001|TWO_SIDED|95.0|-81.61|-28.8||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||-28.80|-81.61|<0.0001
71771779|NCT03981822|143043719|SUPERIORITY||LS mean difference|-76.55|||<|0.0001|TWO_SIDED|95.0|-107.19|-45.61||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||-45.61|-107.19|<0.0001
71771780|NCT03981822|143043719|SUPERIORITY||LS mean difference|-74.29||||0.0003|TWO_SIDED|95.0|-102.96|-31.55||P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.||-31.55|-102.96|0.0003
71831214|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.18||||0.0977|TWO_SIDED|95.0|0.97|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.43|0.97|0.0977
71771781|NCT03981822|143043719|SUPERIORITY||LS mean difference|-77.1||||0.0004|TWO_SIDED|95.0|-110.32|-32.78||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-32.78|-110.32|0.0004
71771782|NCT03981822|143043719|SUPERIORITY||LS mean difference|-77.52||||0.0178|TWO_SIDED|95.0|-120.82|-11.88||P-value is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-11.88|-120.82|0.0178
71771783|NCT03981822|143043720|SUPERIORITY|||||||0.0004||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0004
71771784|NCT03981822|143043720|SUPERIORITY|||||||0.0005||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.||||0.0005
71771785|NCT03981822|143043720|SUPERIORITY|||||||0.0698||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0698
71771786|NCT03981822|143043720|SUPERIORITY|||||||0.01||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.||||0.0100
71771787|NCT03981822|143043720|SUPERIORITY|||||||0.0101||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0101
71771788|NCT03981822|143043720|SUPERIORITY|||||||0.0077||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.||||0.0077
71771789|NCT03981822|143043720|SUPERIORITY|||||||0.064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.||||0.0640
71771790|NCT03981822|143043720|SUPERIORITY|||||||0.0045||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.||||0.0045
71771791|NCT03981822|143043720|SUPERIORITY|||||||0.284||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.2840
71771792|NCT03981822|143043720|SUPERIORITY|||||||0.0132||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||||0.0132
71771793|NCT03981822|143043720|SUPERIORITY|||||||0.4668||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.4668
71771794|NCT03981822|143043720|SUPERIORITY|||||||0.0064||||||P-value is based on the CMH test stratified by gender.|Cochran-Mantel-Haenszel|||Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.||||0.0064
71771795|NCT03981822|143043721|SUPERIORITY|||||||0.0364|||||||Mantel Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0364
71888881|NCT02939131|143298767|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||We computed the average number of scheduled study visits through week 48 for each site. We then averaged the site-level values and compared study groups.||0.5|-0.7|0.74
71730033|NCT02370095|142975269|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|The change in S/F ratio over time was evaluated using a mixed model for repeated measures||||||0.06
71730034|NCT02370095|142975270|SUPERIORITY|||||||0.0679|||||||Wilcoxon (Mann-Whitney)|||||||0.0679
71730035|NCT02370095|142975275|SUPERIORITY|||||||0.567|||||||Mixed Models Analysis|Measurement of MAP were evaluated from baseline to end of treatment||||||0.567
71730036|NCT02370095|142975276|SUPERIORITY|||||||0.2507||||||The threshold for statistical significance was 0.05|Fisher Exact|||||||0.2507
71730037|NCT02370095|142975278|SUPERIORITY|||||||0.5055|||||||Fisher Exact|||||||0.5055
71730038|NCT02130986|142975289|SUPERIORITY||Mean Difference (Net)|-0.05||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
71730039|NCT02130986|142975290|NON_INFERIORITY|Procalcitonin algorithm implementation increases or does not change the proportion of subjects who experience a composite endpoint of adverse outcomes by Day 30. The prespecified noninferiority margin is 4.5 percentage.|Risk Difference (RD)|-0.015|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71771796|NCT03981822|143043721|SUPERIORITY|||||||0.0215|||||||Cochran-Mantel-Haenszel|Stratified by gender||Part B summary is pooled with its respective treatments from Part A.||||0.0215
71730040|NCT02130986|142975291|SUPERIORITY||Risk Difference (RD)|-4.6|||||TWO_SIDED|95.0|-12.2|30.0||||||||30|-12.2|
71730041|NCT02725593|142975365|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.45||0.101|TWO_SIDED|95.0|-1.65|0.15|||Mixed model repeated measures analysis|||||0.15|-1.65|0.101
71730042|NCT02725593|142975366|SUPERIORITY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.81||0.34|TWO_SIDED|95.0|-2.42|0.85|||Mixed model repeated measures analysis|||||0.85|-2.42|0.340
71730043|NCT02725593|142975367|SUPERIORITY||Mean Difference (Final Values)|-3.96||||0.655|TWO_SIDED|95.0|-20.11|9.62|||Fisher's exact test|||||9.62|-20.11|0.655
71730044|NCT02725593|142975368|SUPERIORITY||Mean Difference (Final Values)|20.83||||0.056|TWO_SIDED|95.0|0.5|41.11|||Fisher's exact test|||||41.11|0.50|0.056
71730045|NCT03654885|142975374|NON_INFERIORITY|By assuming the margin of non-inferiority at 24%, the null hypothesis for this non-inferiority testing was to be set up as XEN implanted group (P1)-Trabeculectomy group (P2) ≤-0.24 versus the alternative hypothesis as P1-P2 \>-0.24. Equivalently, non-inferiority of P1 to P2 was to be declared if the lower limit of the 2-sided confidence interval (CI) of the difference of the above endpoint between the two treatment groups computed using normal approximation was found to be greater than -24%.|Percentage Difference|-6.1||||0.487|TWO_SIDED|95.0|-22.9|10.8|||Chi-squared|||||10.8|-22.9|0.487
71730046|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-5.81|STANDARD_ERROR_OF_MEAN|1.155|<|0.001|TWO_SIDED|95.0|-8.074|-3.538||Mixed Model for Repeated Measures (MMRM) model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Day 1||-3.538|-8.074|<0.001
71730047|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.163||0.851|TWO_SIDED|95.0|-2.503|2.066||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 1||2.066|-2.503|0.851
71730048|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.03|STANDARD_ERROR_OF_MEAN|1.162||0.081|TWO_SIDED|95.0|-0.253|4.309||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Week 2||4.309|-0.253|0.081
71730049|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.21|STANDARD_ERROR_OF_MEAN|1.157||0.056|TWO_SIDED|95.0|-0.059|4.484||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 1||4.484|-0.059|0.056
71739051|NCT03688074|142990872|OTHER||Ratio of Geometric LSMeans|1.18||||0.216|TWO_SIDED|90.0|0.94|1.48||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: T cells CD4+ (cells/mm\^2)||95% CI (0.90, 1.55)|1.48|0.94|0.216
71739052|NCT03688074|142990872|OTHER||Ratio of Geometric LSMeans|0.83||||0.26|TWO_SIDED|90.0|0.64|1.09||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Tryptase+ (cells/mm\^2)||95% CI (0.61, 1.15)|1.09|0.64|0.260
71771797|NCT03981822|143043722|SUPERIORITY||LS mean difference|-59.63||||0.1222|TWO_SIDED|95.0|-76.1|9.23||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.||9.23|-76.10|0.1222
71771798|NCT03981822|143043722|SUPERIORITY||LS mean difference|-69.51||||0.0403|TWO_SIDED|95.0|-81.3|-1.9||Analysis based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.||-1.90|-81.30|0.0403
71771799|NCT03981822|143043722|SUPERIORITY||LS mean difference|-58.88||||0.0863|TWO_SIDED|95.0|-77.79|5.33||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||5.33|-77.79|0.0863
71730050|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|4.74|STANDARD_ERROR_OF_MEAN|1.181|<|0.001|TWO_SIDED|95.0|2.416|7.054||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 3||7.054|2.416|<0.001
71730051|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.01|STANDARD_ERROR_OF_MEAN|1.197||0.012|TWO_SIDED|95.0|0.657|5.358||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 6||5.358|0.657|0.012
71730052|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|3.53|STANDARD_ERROR_OF_MEAN|1.197||0.003|TWO_SIDED|95.0|1.182|5.883||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 9||5.883|1.182|0.003
71730053|NCT03654885|142975376|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and Baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change From Baseline in Mean IOP Over Time: Month 12||5.183|0.358|0.024
71730054|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.505|TWO_SIDED|95.0|-0.36|0.18||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Day 1||0.18|-0.36|0.505
71730055|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.949|TWO_SIDED|95.0|-0.28|0.26||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 1||0.26|-0.28|0.949
71730056|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.581|TWO_SIDED|95.0|-0.19|0.34||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Week 2||0.34|-0.19|0.581
71730057|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.302|TWO_SIDED|95.0|-0.13|0.41||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 1||0.41|-0.13|0.302
71771800|NCT03981822|143043722|SUPERIORITY||LS mean difference|-62.13||||0.0428|TWO_SIDED|95.0|-100.76|-1.73||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||-1.73|-100.76|0.0428
71771801|NCT03981822|143043722|SUPERIORITY||LS mean difference|-71.93||||0.0084|TWO_SIDED|95.0|-110.46|-17.0||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||-17.00|-110.46|0.0084
71730058|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|0.12|0.66||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 3||0.66|0.12|0.005
71771802|NCT03981822|143043722|SUPERIORITY||LS mean difference|-63.11||||0.0273|TWO_SIDED|95.0|-103.08|-6.35||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.||-6.35|-103.08|0.0273
71771803|NCT03981822|143043723|SUPERIORITY|Analysis is based on MMRM model|LS mean difference|-44.65||||0.3083|TWO_SIDED|95.0|-69.96|22.47|||Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||22.47|-69.96|0.3083
71771804|NCT03981822|143043723|SUPERIORITY||LS mean difference|-55.8||||0.1686|TWO_SIDED|95.0|-86.93|15.56||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.||15.56|-86.93|0.1686
71730059|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.026|TWO_SIDED|95.0|0.04|0.59||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 6||0.59|0.04|0.026
71730060|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.4|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|95.0|0.09|0.64||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 9||0.64|0.09|0.010
71730061|NCT03654885|142975378|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis.|Mixed Model for Repeated Measures|||Change from Baseline in Mean Number of Topical IOP-Lowering Medications Over Time: Month 12||0.54|0.00|0.052
71730062|NCT03654885|142975379|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|1.229||0.024|TWO_SIDED|95.0|0.358|5.183||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||5.183|0.358|0.024
71730063|NCT03654885|142975380|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.14||0.052|TWO_SIDED|95.0|0.0|0.54||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.54|0.00|0.052
71730064|NCT03654885|142975381|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|2.214||0.421|TWO_SIDED|95.0|-2.579|6.151||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed model repeated measures|||||6.151|-2.579|0.421
71730065|NCT03654885|142975382|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.18|TWO_SIDED|95.0|-0.16|0.84||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables was used for analysis.|Mixed Model for Repeated Measures|||||0.84|-0.16|0.180
71771805|NCT03981822|143043723|SUPERIORITY||LS mean difference|-38.06||||0.2384|TWO_SIDED|95.0|-87.04|22.1||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||22.10|-87.04|0.2384
71831215|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0806|TWO_SIDED|95.0|0.98|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=30% reduction||1.44|0.98|0.0806
71831216|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2097|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.34|0.94|0.2097
71831217|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0135|TWO_SIDED|95.0|1.05|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=50% reduction||1.49|1.05|0.0135
71831218|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.1||||0.3571|TWO_SIDED|95.0|0.9|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.33|0.90|0.3571
71831219|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0025|TWO_SIDED|95.0|1.11|1.63|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=70% reduction||1.63|1.11|0.0025
71771806|NCT03981822|143043723|SUPERIORITY||LS mean difference|-61.96||||0.0603|TWO_SIDED|95.0|-103.37|2.27||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.||2.27|-103.37|0.0603
71771807|NCT03981822|143043723|SUPERIORITY||LS mean difference|-74.87||||0.0109|TWO_SIDED|95.0|-138.71|-18.83||Analysis is based on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.||-18.83|-138.71|0.0109
71831220|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4658|TWO_SIDED|95.0|0.83|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.49|0.83|0.4658
71831221|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0108|TWO_SIDED|95.0|1.09|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: \>=90% reduction||1.90|1.09|0.0108
71831222|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8393|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.22|0.85|0.8393
71831223|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2977|TWO_SIDED|95.0|0.92|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=30% reduction||1.32|0.92|0.2977
71771808|NCT03981822|143043723|SUPERIORITY||LS mean difference|-66.62||||0.0467|TWO_SIDED|95.0|-127.64|-0.99||Analysis is base on MMRM model|Mixed Models Analysis|"MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.~An unstructured covariance model was used."||Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.||-0.99|-127.64|0.0467
71831224|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.12||||0.1944|TWO_SIDED|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.34|0.94|0.1944
71730066|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.7||||0.064|TWO_SIDED|95.0|-33.0|2.3|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤18 mmHg||2.3|-33.0|0.064
71730067|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.3||||0.078|TWO_SIDED|95.0|-32.7|2.5|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤17 mmHg||2.5|-32.7|0.078
71730068|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.4||||0.051|TWO_SIDED|95.0|-34.7|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤16 mmHg||0.4|-34.7|0.051
71730069|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-16.9||||0.064|TWO_SIDED|95.0|-34.1|1.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤15 mmHg||1.0|-34.1|0.064
71730070|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.1||||0.2|TWO_SIDED|95.0|-30.5|4.8|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤14 mm Hg||4.8|-30.5|0.200
71730071|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.0||||0.042|TWO_SIDED|95.0|-37.1|-2.0|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤13 mm Hg||-2.0|-37.1|0.042
71831225|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5714|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=50% reduction||1.26|0.88|0.5714
71888882|NCT02939131|143298768|SUPERIORITY||Mean Difference (Final Values)|-1.99||||0.14|TWO_SIDED|95.0|-4.74|0.76|||t-test, 2 sided||We subtracted the mean of the ESC group from the mean of the COMB-R group. Because a lower score indicated less severe depressive symptoms, a negative value indicated superiority.|We tested the null hypothesis that the treatment group means were equal vs. not.||0.76|-4.74|0.14
71831226|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.12||||0.2472|TWO_SIDED|95.0|0.92|1.36|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.36|0.92|0.2472
71730072|NCT03654885|142975383|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12: IOP Value of ≤12 mm Hg||5.2|-30.1|0.180
71730073|NCT03654885|142975384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-3.6||||0.712|TWO_SIDED|95.0|-21.3|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥25% IOP Reduction||14.2|-21.3|0.712
71730074|NCT03654885|142975384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.9||||0.201|TWO_SIDED|95.0|-30.3|5.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥30% IOP Reduction||5.0|-30.3|0.201
71771809|NCT06460493|143043724|OTHER|The proportion of subjects classified as responders at week 12, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|67.0|||||TWO_SIDED|95.0|38.0|100.0|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||100.0|38.0|
71831227|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0235|TWO_SIDED|95.0|1.03|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=70% reduction||1.51|1.03|0.0235
71831228|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4074|TWO_SIDED|95.0|0.85|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.51|0.85|0.4074
71831229|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0296|TWO_SIDED|95.0|1.03|1.81|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: \>=90% reduction||1.81|1.03|0.0296
71730075|NCT03654885|142975384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.3||||0.03|TWO_SIDED|95.0|-37.3|-2.3|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥35% IOP Reduction||-2.3|-37.3|0.030
71771810|NCT06460493|143043725|OTHER|The proportion of subjects classified as responders at week 6, standard errors, and corresponding 95% CI was estimated by negative binomial regression with background therapy (LABA/LAMA or LABA/LAMA/ICS) included as a fixed effect, and with baseline CAT score included as a covariate. The scale parameter in the negative binomial model was held fixed by specifying a noscale option.|Negative binomial regression|44.4|||||TWO_SIDED|95.0|22.0|89.5|||||A two-sided unadjusted 95% confidence interval for the proportion was used to determine study success with the lower bound of the CI \> 0 indicating success.|||89.5|22.0|
71771811|NCT03577171|143043742|OTHER||LS Mean Difference|-1.154||||0.0077|TWO_SIDED|95.0|-1.986|-0.322|||Repeated measures analysis|||Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12||-0.322|-1.986|0.0077
71771812|NCT03577171|143043742|OTHER||LS Mean Difference|-1.141||||0.0084|TWO_SIDED|95.0|-1.973|-0.309|||Repeated measures analysis|||Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24||-0.309|-1.973|0.0084
71771813|NCT03977454|143043801|SUPERIORITY||Mean Difference (Net)|1.2||||0.69|TWO_SIDED||||||t-test, 2 sided|||The primary endpoint was a comparison between groups at 24 hours.||||0.69
71730076|NCT03654885|142975384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-18.8||||0.043|TWO_SIDED|95.0|-36.0|-0.8|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥40% IOP Reduction||-0.8|-36.0|0.043
71730077|NCT03654885|142975384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.9||||0.048|TWO_SIDED|95.0|-35.1|0.0|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥45% IOP Reduction||0.0|-35.1|0.048
71730078|NCT03654885|142975384|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.1||||0.015|TWO_SIDED|95.0|-38.1|-3.2|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12: ≥50% IOP Reduction||-3.2|-38.1|0.015
71730079|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.7||||0.252|TWO_SIDED|95.0|-29.0|6.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤18 mm Hg||6.3|-29.0|0.252
71730080|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-11.5||||0.258|TWO_SIDED|95.0|-28.9|6.5|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤17 mmHg||6.5|-28.9|0.258
71730081|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-13.6||||0.139|TWO_SIDED|95.0|-30.9|4.4|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤16 mm Hg||4.4|-30.9|0.139
71730082|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.7||||0.136|TWO_SIDED|95.0|-32.0|3.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤15 mm Hg||3.3|-32.0|0.136
71771814|NCT03977454|143043802|SUPERIORITY||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 days post operation.||||0.92
71888883|NCT02939131|143298769|SUPERIORITY||Mean Difference (Final Values)|25.3||||0.05|TWO_SIDED|95.0|0.5|50.0|||t-test, 2 sided||We subtracted the group mean of the site percents with response for the ESC group from that of the COMB-R group. A positive value indicates the COMB-R group had a higher mean percent of participants with response compared to the ESC group.|We tested the null hypothesis that the treatment group means were equal vs. not.||50.0|0.5|0.05
71730083|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.%.|Percentage Difference|-10.8||||0.274|TWO_SIDED|95.0|-28.2|7.1|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤14 mm Hg||7.1|-28.2|0.274
71730084|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-17.7||||0.065|TWO_SIDED|95.0|-35.0|0.3|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤13 mm Hg||0.3|-35.0|0.065
71730085|NCT03654885|142975385|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.7||||0.18|TWO_SIDED|95.0|-30.1|5.2|||Fisher Exact|||Percentage of Participants Achieving at Least a 20% IOP Reductions and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12- IOP Target ≤12 mmHg||5.2|-30.1|0.180
71771815|NCT03977454|143043803|SUPERIORITY||Mean Difference (Net)|0.5||||0.91|TWO_SIDED||||||t-test, 2 sided|||||||0.91
71771816|NCT03977454|143043805|SUPERIORITY||Mean Difference (Net)|0.0||||0.85|TWO_SIDED||||||t-test, 2 sided|||Scores were compared at 2 weeks.||||0.85
71771817|NCT04543409|143043806|SUPERIORITY||Odds Ratio (OR)|117.49|||<|0.0001|TWO_SIDED|95.0|38.17|361.64|||Cochran-Mantel-Haenszel||The OR estimate and p-value was obtained from the CMH test controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. Odds ratio values \>1 favor Benra 30 mg treatment group.|Analysis completed at Week 24.||361.64|38.17|<0.0001
71771818|NCT04543409|143043807|SUPERIORITY|For any patients with intercurrent events, the DSQ scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR). Analysis was repeated on 100 imputed datasets, and results were combined using Rubin's formula.|Difference in Least Squares Means|2.999||||0.177|TWO_SIDED|95.0|-1.36|7.35|||ANCOVA|Model: Change from baseline in DSQ = Treatment + baseline DSQ + Region + Baseline steroid use + Presence of strictures at baseline.||Analysis completed at Week 24.||7.35|-1.36|0.1770
71730086|NCT03654885|142975388|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|1.8||||1|TWO_SIDED|95.0|-41.6|44.1|||Fisher Exact|||||44.1|-41.6|1.000
71730087|NCT03654885|142975389|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-32.1||||0.215|TWO_SIDED|95.0|-66.8|10.0|||Fisher Exact|||||10.0|-66.8|0.215
71730088|NCT03654885|142975391|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-14.9||||0.144|TWO_SIDED|95.0|-32.2|3.1|||Fisher Exact|||||3.1|-32.2|0.144
71730089|NCT03654885|142975392|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-10.6||||0.254|TWO_SIDED|95.0|-28.0|7.3|||Fisher Exact|||||7.3|-28.0|0.254
71730090|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-7.4||||0.563|TWO_SIDED|95.0|-28.6|14.2|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤18 mm Hg||14.2|-28.6|0.563
71730091|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-12.5||||0.188|TWO_SIDED|95.0|-33.5|9.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤17 mm Hg||9.1|-33.5|0.188
71730092|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-15.9||||0.118|TWO_SIDED|95.0|-36.7|5.6|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤16 mmHg||5.6|-36.7|0.118
71730093|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.5||||0.085|TWO_SIDED|95.0|-40.2|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤15 mm Hg||2.1|-40.2|0.085
71730094|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-21.3||||0.059|TWO_SIDED|95.0|-42.0|0.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤14 mm Hg||0.4|-42.0|0.059
71730095|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.5||||0.045|TWO_SIDED|95.0|-43.9|-1.4|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤13 mm Hg||-1.4|-43.9|0.045
71730096|NCT03654885|142975393|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-20.8||||0.076|TWO_SIDED|95.0|-41.3|1.1|||Fisher Exact|||Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye- IOP Target ≤12 mm Hg||1.1|-41.3|0.076
71730097|NCT03654885|142975394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-9.6||||0.464|TWO_SIDED|95.0|-31.0|12.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥ 25% IOP Reduction||12.1|-31.0|0.464
71730098|NCT03654885|142975394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-19.8||||0.069|TWO_SIDED|95.0|-40.6|2.1|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥30% IOP Reduction||2.1|-40.6|0.069
71730099|NCT03654885|142975394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-26.6||||0.023|TWO_SIDED|95.0|-46.9|-4.7|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥35% IOP Reduction||-4.7|-46.9|0.023
71730100|NCT03654885|142975394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-23.7||||0.046|TWO_SIDED|95.0|-43.9|-1.6|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥40% IOP Reduction||-1.6|-43.9|0.046
71730101|NCT03654885|142975394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-27.6||||0.014|TWO_SIDED|95.0|-47.6|-5.9|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥45% IOP Reduction||-5.9|-47.6|0.014
71730102|NCT03654885|142975394|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Percentage Difference|-30.9||||0.006|TWO_SIDED|95.0|-50.8|-9.5|||Fisher Exact|||Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes: ≥50% IOP Reduction||-9.5|-50.8|0.006
71730103|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|0.33|1.72|||Mixed Model for Repeated Measures|MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses: Day 1||1.72|0.33|0.004
71730104|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|0.47|1.88||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 1||1.88|0.47|0.001
71730105|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.162|TWO_SIDED|95.0|-0.2|1.2||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Week 2||1.20|-0.20|0.162
71730106|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.36||0.185|TWO_SIDED|95.0|-0.23|1.19||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 1||1.19|-0.23|0.185
71730107|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.846|TWO_SIDED|95.0|-0.64|0.79||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 3||0.79|-0.64|0.846
71730108|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.965|TWO_SIDED|95.0|-0.73|0.7||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 6||0.70|-0.73|0.965
71730109|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.37||0.096|TWO_SIDED|95.0|-0.11|1.33||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 9||1.33|-0.11|0.096
71730110|NCT03654885|142975401|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.063|TWO_SIDED|95.0|-0.04|1.43||MMRM model with treatment and time as the factors, treatment by time interaction and baseline as the covariate variables were used for analysis|Mixed Model for Repeated Measures|||Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses:Month 12||1.43|-0.04|0.063
71771819|NCT04543409|143043808|SUPERIORITY|For any patients with intercurrent events, the Peak Esophageal intraepithelial eosinophil (eos) counts after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-96.2|||<|0.0001|TWO_SIDED|95.0|-114.53|-77.85|||ANCOVA|Model: Percent change from baseline in Peak Esophageal intraepithelial eos counts = Treatment + baseline Peak Esophageal intraepithelial eos counts.||Analysis completed at Week 24.||-77.85|-114.53|<0.0001
71771820|NCT04543409|143043809|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total grade score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.175|||<|0.0001|TWO_SIDED|95.0|-0.21|-0.14|||ANCOVA|Change from baseline in EoE-HSS TGS = Treatment + baseline EoE-HSS grade score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.14|-0.21|<0.0001
71771821|NCT04543409|143043810|SUPERIORITY|For any patients with intercurrent events, the EoE-HSS total stage score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.122|||<|0.0001|TWO_SIDED|95.0|-0.16|-0.09|||ANCOVA|Change from baseline in EoE-HSS TSS = Treatment + baseline EoE-HSS stage score + Region + Baseline steroid use + Presence of strictures at baseline||||-0.09|-0.16|<0.0001
71771822|NCT04543409|143043811|SUPERIORITY|For any patients with intercurrent events, the centrally-read EREFS total score after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.1||||0.7322|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|Model: Change from baseline in EREFS TS = Treatment + baseline EREFS TS + Region + Baseline steroid use + Presence of strictures at baseline||Analysis completed at Week 24.||0.32|-0.52|0.7322
71771823|NCT04543409|143043812|SUPERIORITY||Odds Ratio (OR)|15.86|||<|0.0001|TWO_SIDED|95.0|5.79|43.47|||Cochran-Mantel-Haenszel||Controlling for region (North America and Rest of the world), baseline steroid use, and presence of strictures at baseline. OR values \>1 would favor Benra 30 mg treatment group.|||43.47|5.79|<0.0001
71771824|NCT04543409|143043816|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.04||||0.8656|TWO_SIDED|95.0|-0.5|0.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related pain.||0.42|-0.50|0.8656
71771825|NCT04543409|143043816|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.181||||0.3926|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Dysphagia-related discomfort.||0.23|-0.60|0.3926
71771826|NCT04543409|143043816|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.344||||0.0867|TWO_SIDED|95.0|-0.74|0.05|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Overall episode severity.||0.05|-0.74|0.0867
71771827|NCT04543409|143043818|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.267||||0.2248|TWO_SIDED|95.0|-0.16|0.7|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Abdominal pain severity||0.70|-0.16|0.2248
71831230|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7607|TWO_SIDED|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.23|0.86|0.7607
71771828|NCT04543409|143043818|SUPERIORITY|For any patients with intercurrent events, the EoE-3D scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.296||||0.1575|TWO_SIDED|95.0|-0.11|0.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Nausea severity.||0.71|-0.11|0.1575
71771829|NCT04543409|143043821|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.202||||0.8239|TWO_SIDED|95.0|-1.57|1.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Eating/Diet Impact||1.98|-1.57|0.8239
71771830|NCT04543409|143043821|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.147||||0.7623|TWO_SIDED|95.0|-0.8|1.1|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social Impact||1.10|-0.80|0.7623
71771831|NCT04543409|143043821|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference of Least Squares Means|0.01||||0.9898|TWO_SIDED|95.0|-1.47|1.49|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Emotional Impact||1.49|-1.47|0.9898
71771832|NCT04543409|143043821|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.386||||0.4603|TWO_SIDED|95.0|-0.64|1.41|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Disease Anxiety||1.41|-0.64|0.4603
71771833|NCT04543409|143043821|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.162||||0.6613|TWO_SIDED|95.0|-0.89|0.56|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Swallowing Anxiety||0.56|-0.89|0.6613
71771834|NCT04543409|143043821|SUPERIORITY|For any patients with intercurrent events, the EoE-QoL-A scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|1.017||||0.6965|TWO_SIDED|95.0|-4.09|6.13|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Total Score||6.13|-4.09|0.6965
71771835|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.3||||0.6852|TWO_SIDED|95.0|-1.93|1.27|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Physical functioning (PF)||1.27|-1.93|0.6852
71771836|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.2685|TWO_SIDED|95.0|-2.57|0.72|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to physical health (RP)||0.72|-2.57|0.2685
71771837|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.8||||0.538|TWO_SIDED|95.0|-3.27|1.71|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Bodily pain (BP)||1.71|-3.27|0.5380
71831231|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.02||||0.7979|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=30% reduction||1.22|0.86|0.7979
71831232|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.1||||0.2964|TWO_SIDED|95.0|0.92|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.31|0.92|0.2964
71771838|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9734|TWO_SIDED|95.0|-1.81|1.75|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||General health perceptions (GH)||1.75|-1.81|0.9734
71831233|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.04||||0.695|TWO_SIDED|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=50% reduction||1.24|0.87|0.6950
71831234|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1985|TWO_SIDED|95.0|0.93|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.38|0.93|0.1985
71831235|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.17||||0.1239|TWO_SIDED|95.0|0.96|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=70% reduction||1.42|0.96|0.1239
71831236|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2762|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.58|0.88|0.2762
71831237|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.44||||0.0121|TWO_SIDED|95.0|1.08|1.91|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: \>=90% reduction||1.91|1.08|0.0121
71831238|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8443|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8443
71831239|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8472|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=30% reduction||1.22|0.85|0.8472
71831240|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.01||||0.898|TWO_SIDED|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.21|0.85|0.8980
71831241|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=50% reduction||1.19|0.83|0.9385
71831242|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4261|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.32|0.89|0.4261
71831243|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.07||||0.525|TWO_SIDED|95.0|0.88|1.3|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=70% reduction||1.30|0.88|0.5250
71831244|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6273|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.45|0.80|0.6273
71831245|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0132|TWO_SIDED|95.0|1.08|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: \>=90% reduction||1.90|1.08|0.0132
71730111|NCT03654885|142975402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.027||0.048|TWO_SIDED|95.0|-0.105|0.0|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 1||0.000|-0.105|0.048
71730112|NCT03654885|142975402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.027||0.742|TWO_SIDED|95.0|-0.062|0.045|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 3||0.045|-0.062|0.742
71730113|NCT03654885|142975402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.027||0.925|TWO_SIDED|95.0|-0.056|0.051|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 6||0.051|-0.056|0.925
71730114|NCT03654885|142975402|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.028||0.021|TWO_SIDED|95.0|-0.118|-0.01|||Mixed Model for Repeated Measures|||Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen in LogMAR Scale: Month 12||-0.010|-0.118|0.021
71730115|NCT03654885|142975405|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.562|STANDARD_ERROR_OF_MEAN|0.3231||0.087|TWO_SIDED|95.0|-1.2082|0.0851|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Week 1||0.0851|-1.2082|0.087
71730116|NCT03654885|142975405|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.3355||0.682|TWO_SIDED|95.0|-0.809|0.5324|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 1||0.5324|-0.8090|0.682
71730117|NCT03654885|142975405|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.452|STANDARD_ERROR_OF_MEAN|0.3484||0.199|TWO_SIDED|95.0|-1.1483|0.2434|||Mixed Model for Repeated Measures|||Mean Change from Baseline in Surgically Induced Astigmatism - Topography at Selected Sites at Month 12||0.2434|-1.1483|0.199
71831246|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9095|TWO_SIDED|95.0|0.83|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.18|0.83|0.9095
71831247|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5098|TWO_SIDED|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=30% reduction||1.12|0.79|0.5098
71831248|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.07||||0.4488|TWO_SIDED|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.28|0.90|0.4488
71831249|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9757|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=50% reduction||1.19|0.83|0.9757
71831250|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.14||||0.1843|TWO_SIDED|95.0|0.94|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.39|0.94|0.1843
71831251|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.08||||0.4356|TWO_SIDED|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=70% reduction||1.32|0.89|0.4356
71831252|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6342|TWO_SIDED|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.45|0.80|0.6342
71831253|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.29||||0.081|TWO_SIDED|95.0|0.97|1.73|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: \>=90% reduction||1.73|0.97|0.0810
71831254|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6527|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.15|0.80|0.6527
71831255|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|0.92||||0.3857|TWO_SIDED|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=30% reduction||1.10|0.77|0.3857
71831256|NCT02528188|143167431|SUPERIORITY||Odds Ratio, log|1.06||||0.528|TWO_SIDED|95.0|0.89|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.27|0.89|0.5280
71831257|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|0.94||||0.5355|TWO_SIDED|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=50% reduction||1.13|0.79|0.5355
71831258|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7732|TWO_SIDED|95.0|0.84|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.26|0.84|0.7732
71888884|NCT02939131|143298770|SUPERIORITY||Mean Difference (Final Values)|16.3||||0.24|TWO_SIDED|95.0|-12.3|44.8|||t-test, 2 sided||We subtracted the group mean of the site percents with remission for the ESC group from the COMB-R group so a positive value indicates the COMB-R group has more participants with remission.|We tested the null hypothesis that the treatment group means were equal vs. not.||44.8|-12.3|0.24
71730118|NCT03654885|142975406|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.001|STANDARD_ERROR_OF_MEAN|0.2026||0.997|TWO_SIDED|95.0|-0.4103|0.4086|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Day 1||0.4086|-0.4103|0.997
71730119|NCT03654885|142975406|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.2124||0.302|TWO_SIDED|95.0|-0.2068|0.6506|||Mixed Model for Repeated Measures|||Mean Change in Optical Biometry - Anterior Chamber Depth at Week 2||0.6506|-0.2068|0.302
71730120|NCT03654885|142975407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.343|STANDARD_ERROR_OF_MEAN|0.3336||0.309|TWO_SIDED|95.0|-0.3289|1.0154|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Day 1||1.0154|-0.3289|0.309
71730121|NCT03654885|142975407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|0.261|STANDARD_ERROR_OF_MEAN|0.3278||0.43|TWO_SIDED|95.0|-0.3993|0.922|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K1 at Week 2||0.9220|-0.3993|0.430
71771839|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|0.0||||0.9653|TWO_SIDED|95.0|-2.09|2.19|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Vitality (VT)||2.19|-2.09|0.9653
71771840|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-1.5||||0.2326|TWO_SIDED|95.0|-4.04|0.98|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Social functioning (SF)||0.98|-4.04|0.2326
71771841|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.7||||0.6274|TWO_SIDED|95.0|-3.44|2.08|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Role limitations due to emotional problems (RE)||2.08|-3.44|0.6274
71771842|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.9||||0.4599|TWO_SIDED|95.0|-3.14|1.42|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Mental health (MH)||1.42|-3.14|0.4599
71771843|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.4||||0.6456|TWO_SIDED|95.0|-2.07|1.28|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline||Psychometrically-based physical summary score (PCS)||1.28|-2.07|0.6456
71771844|NCT04543409|143043823|SUPERIORITY|For any patients with intercurrent events, the SF-36 domain scores after the occurrence of those events were imputed using return-to-baseline MI. Missing data not due to intercurrent events were imputed using MI (MAR).|Difference in Least Squares Means|-0.6||||0.6206|TWO_SIDED|95.0|-3.08|1.84|||ANCOVA|Model: Change from baseline item score = Treatment + baseline item score + Region + Baseline steroid use + Presence of strictures at baseline.||Mental health component summary scores (MCS)||1.84|-3.08|0.6206
71771845|NCT00518973|143043845|SUPERIORITY|||||||0.15||||||t = 2.8|t-test, 2 sided|Hours occupied by preoccupations.||||||.15
71771846|NCT00518973|143043845|SUPERIORITY|||||||0.4||||||t = .56|t-test, 2 sided|Hours of rituals||||||.40
71771847|NCT00518973|143043846|SUPERIORITY|||||||0.72||||||t = .13|t-test, 2 sided|||||||.72
71771848|NCT00518973|143043847|SUPERIORITY|||||||0.48||||||t = .52|t-test, 2 sided|Reporting for Trait||||||.48
71771849|NCT00518973|143043847|SUPERIORITY|||||||0.77||||||t = .09|t-test, 2 sided|Reporting for State||||||.77
71831259|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9397|TWO_SIDED|95.0|0.82|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=70% reduction||1.23|0.82|0.9397
71771850|NCT00518973|143043848|SUPERIORITY|||||||0.83||||||t = .05|t-test, 2 sided|||||||.83
71771851|NCT00518973|143043849|SUPERIORITY|||||||0.4||||||t = .78|t-test, 2 sided|Positive Scale||||||.40
71771852|NCT00518973|143043849|SUPERIORITY|||||||0.11||||||t=3.0|t-test, 2 sided|Negative Scale||||||.11
71771853|NCT00518973|143043849|SUPERIORITY|||||||0.9||||||t = .02|t-test, 2 sided|General Scale||||||.90
71771854|NCT02129777|143043850|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.008||||0.925|TWO_SIDED|95.0|-0.162|0.179|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.179|-0.162|0.925
71771855|NCT02129777|143043850|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.162|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.162
71771856|NCT02129777|143043850|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.034||||0.671|TWO_SIDED|95.0|-0.187|0.118|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.118|-0.187|0.671
71771857|NCT02129777|143043850|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.087||||0.182|TWO_SIDED|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.028|-0.202|0.182
71771858|NCT02129777|143043852|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.75||0.435|TWO_SIDED|95.0|-2.1|4.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||4.9|-2.1|0.435
71771859|NCT02129777|143043852|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.74||0.279|TWO_SIDED|95.0|-1.6|5.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||5.4|-1.6|0.279
71730122|NCT03654885|142975407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.409|STANDARD_ERROR_OF_MEAN|0.4457||0.363|TWO_SIDED|95.0|-1.3071|0.4882|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Day 1||0.4882|-1.3071|0.363
71730123|NCT03654885|142975407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.488|STANDARD_ERROR_OF_MEAN|0.4383||0.272|TWO_SIDED|95.0|-1.3709|0.3954|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - K2 at Week 2||0.3954|-1.3709|0.272
71730124|NCT03654885|142975407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.765|STANDARD_ERROR_OF_MEAN|0.4502||0.096|TWO_SIDED|95.0|-1.6722|0.142|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Day 1||0.1420|-1.6722|0.096
71771860|NCT02129777|143043852|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.74||0.085|TWO_SIDED|95.0|-0.4|6.5|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.5|-0.4|0.085
71771861|NCT02129777|143043852|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|1.76||0.11|TWO_SIDED|95.0|-0.7|6.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.||6.3|-0.7|0.110
71771862|NCT02129777|143043853|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.827|TWO_SIDED|95.0|-0.265|0.211|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.211|-0.265|0.827
71771863|NCT02129777|143043853|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.036||||0.768|TWO_SIDED|95.0|-0.269|0.198|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.198|-0.269|0.768
71771864|NCT02129777|143043853|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.112||||0.338|TWO_SIDED|95.0|-0.33|0.106|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.106|-0.330|0.338
71771865|NCT02129777|143043853|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.017||||0.89|TWO_SIDED|95.0|-0.261|0.226|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.226|-0.261|0.890
71771866|NCT02129777|143043854|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.048||||0.295|TWO_SIDED|95.0|-0.043|0.139|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12:CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and responder status controlling for visit.||0.139|-0.043|0.295
71831260|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9044|TWO_SIDED|95.0|0.75|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.39|0.75|0.9044
71831261|NCT02528188|143167431|SUPERIORITY||Odds Ratio (OR)|1.16||||0.3193|TWO_SIDED|95.0|0.86|1.57|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: \>=90% reduction||1.57|0.86|0.3193
71831262|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1772|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.62|0.91|0.1772
71730125|NCT03654885|142975407|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.576|STANDARD_ERROR_OF_MEAN|0.4411||0.198|TWO_SIDED|95.0|-1.4655|0.3129|||Mixed Model for Repeated Measures|||Mean Change in from Baseline Optical Biometry - Delta D at Week 2||0.3129|-1.4655|0.198
71730126|NCT03654885|142975418|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-3.031|STANDARD_ERROR_OF_MEAN|4.3331||0.485|TWO_SIDED|95.0|-11.5597|5.4973|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Score||5.4973|-11.5597|0.485
71771867|NCT02129777|143043855|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.012||||0.906|TWO_SIDED|95.0|-0.191|0.216|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.216|-0.191|0.906
71771868|NCT02129777|143043855|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04||||0.677|TWO_SIDED|95.0|-0.222|0.143|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.143|-0.222|0.677
71771869|NCT02129777|143043855|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13||||0.107|TWO_SIDED|95.0|-0.268|0.007|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.007|-0.268|0.107
71831263|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0154|TWO_SIDED|95.0|1.07|1.89|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.89|1.07|0.0154
71661169|NCT03786718|142835934|OTHER|||||||0.3|||||||McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||0.30
71730127|NCT03654885|142975418|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-10.507|STANDARD_ERROR_OF_MEAN|4.5666||0.022|TWO_SIDED|95.0|-19.5|-1.5144|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Score||-1.5144|-19.5000|0.022
71730128|NCT03654885|142975418|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-7.528|STANDARD_ERROR_OF_MEAN|4.0382||0.064|TWO_SIDED|95.0|-15.4841|0.4275|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Total Bothersome Score||0.4275|-15.4841|0.064
71730129|NCT03654885|142975418|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.278|TWO_SIDED|95.0|-1.28|0.37|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Local Eye Symptoms Frequency Score||0.37|-1.28|0.278
71730130|NCT03654885|142975418|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.63||0.007|TWO_SIDED|95.0|-2.96|-0.47|||Mixed Model for Repeated Measures|||PRO: Change From Baseline in Symptom and Health Problem Checklist (SHPC-18)- Vision Function Problem Frequency Score||-0.47|-2.96|0.007
71730131|NCT03654885|142975419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.534|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Not at all||||0.534
71730132|NCT03654885|142975419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.263|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Somewhat||||0.263
71730133|NCT03654885|142975419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||1|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Moderately so||||1.000
71730134|NCT03654885|142975419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.018|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Mostly||||0.018
71730135|NCT03654885|142975419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.35|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Completely||||0.350
71831264|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0105|TWO_SIDED|95.0|1.08|1.81|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.81|1.08|0.0105
71730136|NCT03654885|142975419|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.||||||0.264|||||||Fisher Exact|||PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine- Missing||||0.264
71730137|NCT03654885|142975420|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-8.303|STANDARD_ERROR_OF_MEAN|16.1445||0.61|TWO_SIDED|95.0|-40.8681|24.2624|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment- Percent Overall Work Impairment Due to Health||24.2624|-40.8681|0.610
71730138|NCT03654885|142975421|OTHER|No formal hypothesis was planned. P-value for treatment differences was provided for reference.|Least Square Mean Difference|-13.9|STANDARD_ERROR_OF_MEAN|8.33||0.097|TWO_SIDED|95.0|-30.32|2.52|||Mixed Model for Repeated Measures|||PRO: Percent Change From Baseline in Work Productivity and Activity Impairment-Percent Activity Impairment Due to Health||2.52|-30.32|0.097
71661170|NCT03786718|142835934|OTHER|||||||1|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||1.00
71661171|NCT03786718|142835934|OTHER|||||||0.63|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.63
71730139|NCT04411420|142975428|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.169|TWO_SIDED|97.5|-1.55|0.37||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||0.37|-1.55|0.169
71739053|NCT03688074|142990872|OTHER||Ratio of Geometric LSMeans|1.19||||0.546|TWO_SIDED|90.0|0.74|1.92||Nominal p-values were reported. No adjustment of multiplicity was performed.|ANCOVA|Model includes treatment+log transformed baseline value+stratification factor (screening eos count \[\<150, 150-\<300, \>=300 cells/uL\])|Parameter: Mast cells Chymase+ (cells/mm\^2)||95% CI (0.67, 2.10)|1.92|0.74|0.546
71739054|NCT03928717|142990889|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71739055|NCT03928717|142990890|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71739056|NCT00082407|142990891|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and biphasic insulin aspart is less than 0.4%.)|Mean Difference (Final Values)|-0.1||||0.2534||95.0|-0.28|0.08|||ANCOVA|||||0.08|-0.28|0.2534
71739057|NCT00082407|142990892|SUPERIORITY_OR_OTHER|||||||0.0779||95.0|||||Fisher Exact|||||||0.0779
71739058|NCT00082407|142990893|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71730140|NCT04411420|142975429|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.139|TWO_SIDED|97.5|-0.33|1.52||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.|||1.52|-0.33|0.139
71730141|NCT04411420|142975430|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.417|TWO_SIDED|95.0|-1.69|0.72||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.||||0.72|-1.69|0.417
71730142|NCT04411420|142975431|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.409|TWO_SIDED|95.0|-1.37|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.57|-1.37|0.409
71730143|NCT04411420|142975431|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.899|TWO_SIDED|95.0|-1.04|0.91||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-1.04|0.899
71730144|NCT04411420|142975431|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.946|TWO_SIDED|95.0|-1.01|1.08||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||1.08|-1.01|0.946
71730145|NCT04411420|142975432|SUPERIORITY||Odds Ratio, log|-0.004||||0.992|TWO_SIDED|95.0|-4.62|4.61||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Regression, Logistic|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Odds Ratio calculated for Integrated Sequenced Care Pathway relative to Coordinated Care Management Pathway.|||4.61|-4.62|0.992
71730146|NCT04411420|142975433|SUPERIORITY||Median Difference (Final Values)|-2.67||||0.262|TWO_SIDED|95.0|-7.52|2.18||P-value is not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|||2.18|-7.52|0.262
71831265|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0002|TWO_SIDED|95.0|1.26|2.1|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||2.10|1.26|0.0002
71730147|NCT04411420|142975434|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.37|TWO_SIDED|97.5|-1.31|0.5||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.50|-1.31|0.37
71730148|NCT04411420|142975434|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.24|TWO_SIDED|97.5|-1.54|0.39||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.39|-1.54|0.24
71730149|NCT04411420|142975434|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.37|TWO_SIDED|97.5|-1.43|0.54|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.54|-1.43|0.37
71730150|NCT04411420|142975435|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.727|TWO_SIDED|97.5|-0.51|0.72||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.72|-0.51|0.727
71730151|NCT04411420|142975435|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.478|TWO_SIDED|97.5|-0.43|0.91||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.91|-0.43|0.478
71730152|NCT04411420|142975435|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.894|TWO_SIDED|97.5|-0.75|0.66||Threshold for significance is 0.025 due to dual primary outcomes.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.66|-0.75|0.894
71730153|NCT04411420|142975436|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.222|TWO_SIDED|95.0|-0.15|0.04||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.04|-0.15|0.222
71739059|NCT00082407|142990894|SUPERIORITY_OR_OTHER|||||||0.6456||95.0|||||ANCOVA|||||||0.6456
71739060|NCT00082407|142990896|SUPERIORITY_OR_OTHER|||||||0.7888||95.0|||||Fisher Exact|||||||0.7888
71771870|NCT02129777|143043855|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.371|TWO_SIDED|95.0|-0.248|0.087|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.087|-0.248|0.371
71771871|NCT02129777|143043856|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.095||||0.134|TWO_SIDED|95.0|-0.03|0.221|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2\*2 contingency table of treatment and sPGA response category controlling for visit.||0.221|-0.030|0.134
71730154|NCT04411420|142975436|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.1|0.09||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.09|-0.10|0.988
71730155|NCT04411420|142975436|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.269|TWO_SIDED|95.0|-0.16|0.05||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.05|-0.16|0.269
71730156|NCT04411420|142975437|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.477|TWO_SIDED|95.0|-0.22|0.1||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.10|-0.22|0.477
71730157|NCT04411420|142975437|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.877|TWO_SIDED|95.0|-0.19|0.17||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.17|-0.19|0.877
71730158|NCT04411420|142975437|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.36|TWO_SIDED|95.0|-0.29|0.11|||Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.11|-0.29|0.360
71730159|NCT04411420|142975438|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.23|0.28||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.28|-0.23|0.858
71730160|NCT04411420|142975438|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.688|TWO_SIDED|95.0|-0.32|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.21|-0.32|0.688
71730161|NCT04411420|142975438|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.833|TWO_SIDED|95.0|-0.32|0.26||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.26|-0.32|0.833
71730162|NCT04411420|142975439|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.259|TWO_SIDED|95.0|-0.18|0.64||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.64|-0.18|0.259
71661172|NCT03786718|142835934|OTHER|||||||0.02|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.02
71730163|NCT04411420|142975439|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.068|TWO_SIDED|95.0|-0.03|0.81||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.81|-0.03|0.068
71730164|NCT04411420|142975439|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.514|TWO_SIDED|95.0|-0.29|0.57||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.57|-0.29|0.514
71771872|NCT02129777|143043857|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.258|TWO_SIDED|95.0|-0.6|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.||0.2|-0.6|0.258
71661173|NCT03786718|142835934|OTHER|||||||0.55|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.55
71661174|NCT03786718|142835934|OTHER|||||||0.0009|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.0009
71730165|NCT04411420|142975440|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.895|TWO_SIDED|95.0|-0.22|0.2||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.20|-0.22|0.895
71730166|NCT04411420|142975440|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.438|TWO_SIDED|95.0|-0.13|0.3||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.30|-0.13|0.438
71730167|NCT04411420|142975440|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.89|TWO_SIDED|95.0|-0.24|0.21||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.21|-0.24|0.890
71730168|NCT04411420|142975441|SUPERIORITY||Median Difference (Final Values)|-0.01||||0.508|TWO_SIDED|95.0|-0.04|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 3 months||0.02|-0.04|0.508
71730169|NCT04411420|142975441|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.03|0.03||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 6 months||0.03|-0.03|0.992
71730170|NCT04411420|142975441|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.389|TWO_SIDED|95.0|-0.05|0.02||P-values are not adjusted for multiple comparisons. Threshold for significance is 0.05.|Mixed Models Analysis|Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.|Difference is calculated as Integrated Sequenced Care Pathway change minus Coordinated Care Management Pathway change.|Baseline to 12 months||0.02|-0.05|0.389
71730171|NCT02210832|142975453|SUPERIORITY|38.27% vs. 9.09%|||||<|0.001||||||p value is not adjusted for multiple comparisons. A priori threshold for significance was P \< 0.05.|Chi-squared|chi square test statistic = 20.23, df = 1||Hypothesized that women assigned to Best practices plus financial incentives would achieve greater abstinence than women assigned to Best practices only.||||<0.001
71730172|NCT02210832|142975454|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Used generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||||||<0.05
71730173|NCT02210832|142975454|SUPERIORITY|||||||0.003||||||chi square test statistic = 21.93, df=7|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Trial condition by assessment time interaction||||0.003
71730174|NCT02210832|142975455|SUPERIORITY|||||||0.48||||||chi square test statistic = 9.52, df = 10|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Interaction of trial condition and time||||0.48
71730175|NCT02210832|142975456|SUPERIORITY||||||<|0.0001||||||chi square test statistic = 33.51, df = 2|Mixed Models Analysis|Conducted a generalized estimating equation utilizing a logistic link function with treatment condition and assessment time adjusting for covariates.||Examining main effect of treatment condition.||||<0.0001
71831266|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4007|TWO_SIDED|95.0|0.87|1.43|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.43|0.87|0.4007
71831267|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0116|TWO_SIDED|95.0|1.07|1.75|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.75|1.07|0.0116
71730176|NCT02210832|142975456|SUPERIORITY|||||||0.89||||||chi square test statistic = 5.00, df = 10.|Mixed Models Analysis|||Testing interaction of treatment condition and assessment time||||0.89
71730177|NCT02210832|142975457|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
71730178|NCT02210832|142975458|SUPERIORITY||||||<|0.001||||||F\[7,922\]=3.62|ANCOVA|Repeated measures analysis of covariance was conducted with Bonferroni corrections for post-doc tests and across repeated assessments.||Examine interaction of treatment condition and assessment time.||||<0.001
71730179|NCT02210832|142975458|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||<0.001
71730180|NCT02210832|142975459|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|Method was mixed model repeated measures analysis of covariance.||||||0.009
71730181|NCT02210832|142975460|SUPERIORITY|||||||0.01|||||||Regression, Logistic|Method is logistic regression adjusted for covariates.||||||0.01
71730182|NCT02210832|142975461|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71730183|NCT02210832|142975462|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71730184|NCT02210832|142975464|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71730185|NCT02210832|142975468|SUPERIORITY|||||||0.006|||||||ANCOVA|All comparisons adjusted for infant gestational age at time of delivery.||||||0.006
71739061|NCT00082407|142990897|SUPERIORITY_OR_OTHER|||||||0.3722||95.0|||||ANCOVA|||||||0.3722
71739062|NCT00118742|142990906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0012||95.0|14.8|35.0|||ANCOVA|||||35.0|14.8|0.0012
71739063|NCT00118742|142990907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|||<|0.0001||95.0|15.7|35.6|||ANCOVA|||||35.6|15.7|<0.0001
71730186|NCT02080260|142975475|SUPERIORITY||16-week PFS Rate|0.1||||0.824|TWO_SIDED|95.0|0.012|0.317||This p-value is only based on partial enrollment of the study. The study enrollment was stopped early due to futility.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|The null hypothesis assumes a median PFS of 6 weeks, corresponding to a 16-week PFS rate of approximately 0.15. A single-stage design will be used to test that the 16-week PFS rate is less than or equal to 0.15. If at least 8 of the 32 subjects are alive and progression free at 16 weeks, the null hypothesis will be rejected. Assuming a one-sided alpha = 0.10 significance level, this will provide at least 90% power to reject the null hypothesis, assuming the true 16-week PFS rate is 0.35.||0.317|0.012|0.824
71730187|NCT02080260|142975476|OTHER|Estimation only.|Median|6.1|||||TWO_SIDED|95.0|2.9|7.1|||||The Kaplan Meier method was used to estimate the median PFS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||7.1|2.9|
71730188|NCT02080260|142975477|OTHER|Estimation only.|Median|9.4|||||TWO_SIDED|95.0|8.1|17.0|||||The Kaplan Meier method was used to estimate the median OS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||17.0|8.1|
71730189|NCT02080260|142975478|OTHER|Estimation only|Overall Response Rate|0.05|||||TWO_SIDED|95.0|0.001|0.249|||||Confidence interval estimated using the Clopper Pearson method.|||0.249|0.001|
71730190|NCT02080260|142975479|OTHER|Estimation only.|Disease Control Rate|0.3|||||TWO_SIDED|95.0|0.119|0.543|||||Confidence interval estimated using the Clopper Pearson method.|||0.543|0.119|
71730191|NCT00628589|142975499|SUPERIORITY|LS mean was used in the primary efficacy analysis||||||0.0004|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||0.0004
71730192|NCT00628589|142975499|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model||||||<0.0001
71730193|NCT00628589|142975500|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
71730194|NCT00628589|142975500|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71730195|NCT00628589|142975501|SUPERIORITY|||||||0.0015|||||||Fisher Exact|||||||0.0015
71730196|NCT00628589|142975501|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71730197|NCT01030874|142975508|OTHER||Odds Ratio (OR)|1.16||||0.6|TWO_SIDED|95.0|0.67|1.99|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at baseline.|Arm 2 is in the numerator of OR calculation.|||1.99|0.67|0.6
71730198|NCT01030874|142975509|OTHER||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.74|3.24|||Regression, Logistic|Adjusted for whether patient had orthostatic hypotension at discharge.|Arm 2 is in the numerator of OR calculation.|||3.24|0.74|0.3
71730199|NCT01891344|142975541|SUPERIORITY||Cox Proportional Hazard|0.273|||||TWO_SIDED|95.0|0.17|0.437||||||||0.437|0.170|
71730200|NCT01891344|142975541|SUPERIORITY||Cox Proportional Hazard|0.61|||||TWO_SIDED|95.0|0.428|0.871||||||||0.871|0.428|
71730201|NCT02590562|142975616|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||F test|||||||<0.0001
71730202|NCT02590562|142975617|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||F test|||||||0.0108
71730203|NCT02042534|142975633|SUPERIORITY_OR_OTHER|||||||0.6765|||||||Chi-squared|||||||0.6765
71730204|NCT02042534|142975634|SUPERIORITY_OR_OTHER|||||||0.3753|||||||Chi-squared|||||||0.3753
71730205|NCT02042534|142975635|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||<.0001
71730206|NCT02042534|142975636|SUPERIORITY_OR_OTHER|||||||0.3301|||||||Cochran-Mantel-Haenszel|||||||0.3301
71730207|NCT00598078|142975644|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||||||0.013
71730208|NCT00598078|142975644|SUPERIORITY_OR_OTHER|||||||0.713||95.0|||||ANOVA|||||||0.713
71730209|NCT00598078|142975644|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANOVA|||||||0.038
71730210|NCT02133664|142975659|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.57||0.05|TWO_SIDED|95.0|-2.03|4.32|||t-test, 2 sided|||With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.||4.32|-2.03|0.05
71730211|NCT00300482|142975663|SUPERIORITY_OR_OTHER||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71730212|NCT00300482|142975663|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide \>99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71730213|NCT00300482|142975664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71730214|NCT00300482|142975664|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71730215|NCT00300482|142975665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71730216|NCT00300482|142975665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71730217|NCT02120365|142975671|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|1.986||0.867|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Medication dose was a within-subjects factor (crossover design)||||0.867
71831268|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6279|TWO_SIDED|95.0|0.76|1.18|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.18|0.76|0.6279
71831269|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4674|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.35|0.87|0.4674
71831270|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3135|TWO_SIDED|95.0|0.71|1.12|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.71|0.3135
71831271|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7581|TWO_SIDED|95.0|0.83|1.3|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.30|0.83|0.7581
71831272|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.92||||0.4504|TWO_SIDED|95.0|0.73|1.15|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.73|0.4504
71831273|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.88||||0.2629|TWO_SIDED|95.0|0.7|1.1|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.10|0.70|0.2629
71888885|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|6.79||||0.01|TWO_SIDED|95.0|2.3|11.28||This is the test of effect modification by sex at birth|t-test, 2 sided||A positive value indicates that the treatment difference (lower QIDS-SR score with COMB-R than with ESC) was greater for females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||11.28|2.30|0.01
71730218|NCT02120365|142975672|SUPERIORITY||Mean Difference (Final Values)|5.514|STANDARD_ERROR_OF_MEAN|3.038||0.071|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models, medication was a within-subjects factor||||0.071
71730219|NCT02120365|142975673|SUPERIORITY||Mean Difference (Final Values)|0.729|STANDARD_ERROR_OF_MEAN|2.905||0.667|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|mixed models||||0.667
71730220|NCT02120365|142975674|SUPERIORITY||Mean Difference (Final Values)|2.242|STANDARD_ERROR_OF_MEAN|1.393||0.285|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|||||0.285
71730221|NCT02120365|142975675|SUPERIORITY||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.408||0.843|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|Mixed Models||||.843
71730222|NCT02120365|142975676|SUPERIORITY||Mean Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|2.07||0.691|TWO_SIDED||||||Mixed Models Analysis||Representing the high dose 10mg compared to the placebo 0mg dose.|We report the main effect of dose on the outcome measure||||.691
71730223|NCT01726673|142975677|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|302.0||||0.256|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.256
71730224|NCT01726673|142975677|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|222.0||||0.222|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.222
71730225|NCT01726673|142975678|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U Value|251.5||||1|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||1.0
71739064|NCT00118742|142990908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.7||||0.0053||95.0|13.7|43.7|||ANCOVA|||||43.7|13.7|0.0053
71831274|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.95||||0.6763|TWO_SIDED|95.0|0.75|1.2|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.75|0.6763
71730226|NCT01726673|142975678|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|208.5||||0.592|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.592
71730227|NCT01726673|142975679|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|270.5||||0.68|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test|||||||0.680
71730228|NCT01726673|142975679|EQUIVALENCE|Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|187.5||||0.837|TWO_SIDED|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test|||||||0.837
71730229|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0056|TWO_SIDED|95.0|-0.56|-0.1|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.10|-0.56|0.0056
71730230|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.48|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.48|-0.95|<0.0001
71730231|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.75|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.98|-0.51|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.51|-0.98|<0.0001
71730232|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted mean|-0.57|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.81|-0.34|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.34|-0.81|<0.0001
71730233|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted mean|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment||-0.09|-0.56|0.0062
71831275|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9456|TWO_SIDED|95.0|0.8|1.27|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.27|0.80|0.9456
71739065|NCT00118742|142990909|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|21.1|||<|0.0001||95.0|12.5|29.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 6 months posttransplant||29.6|12.5|<0.0001
71831276|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.96||||0.752|TWO_SIDED|95.0|0.76|1.22|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.76|0.7520
71888886|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.23|TWO_SIDED|95.0|-7.05|1.93||This is the test of effect modification by age group|t-test, 2 sided||A negative value indicates the treatment difference is greater for younger compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||1.93|-7.05|0.23
71730234|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.72|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.95|-0.49|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.49|-0.95|<0.0001
71730235|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.56|-1.03|<0.0001
71730236|NCT01719003|142975680|SUPERIORITY_OR_OTHER||Adjusted mean|-0.63|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.86|-0.4|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||-0.40|-0.86|<0.0001
71730237|NCT01719003|142975680|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.39|STANDARD_ERROR_OF_MEAN|0.12||0.6246|TWO_SIDED|95.0|0.15|0.62|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 25 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.62|0.15|0.6246
71730238|NCT01719003|142975680|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.4|STANDARD_ERROR_OF_MEAN|0.12||0.6558|TWO_SIDED|95.0|0.16|0.63|||Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 10 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.||0.63|0.16|0.6558
71730239|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted mean|-18.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-25.5|-12.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-12.2|-25.5|<0.0001
71730240|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted mean|-23.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-29.7|-16.3||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-16.3|-29.7|<0.0001
71730241|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted Mean|-26.7|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-33.5|-20.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-20.0|-33.5|<0.0001
71730242|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted mean|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.8|-9.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-9.2|-22.8|<0.0001
71730243|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted mean|-15.6|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-22.3|-8.9||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment||-8.9|-22.3|<0.0001
71730244|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted Mean|-14.8|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-21.4|-8.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-8.2|-21.4|<0.0001
71730245|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted Mean|-28.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-35.0|-21.5||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-21.5|-35.0|<0.0001
71730246|NCT01719003|142975681|SUPERIORITY_OR_OTHER||Adjusted mean|-12.6|STANDARD_ERROR_OF_MEAN|3.4||0.0002|TWO_SIDED|95.0|-19.1|-6.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.||-6.0|-19.1|0.0002
71730247|NCT01719003|142975682|SUPERIORITY_OR_OTHER||Adjusted mean|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.33|-1.68||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.68|-3.33|<0.0001
71730248|NCT01719003|142975682|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.52|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.35|-1.69||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.69|-3.35|<0.0001
71730249|NCT01719003|142975682|SUPERIORITY_OR_OTHER||Adjusted mean|-2.2|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.03|-1.37||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment||-1.37|-3.03|<0.0001
71739066|NCT00118742|142990909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.2|||<|0.0001||95.0|9.9|26.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 12 months posttransplant||26.6|9.9|<0.0001
71739067|NCT00118742|142990909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.6||||0.0006||95.0|10.2|37.0|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 24 months posttransplant||37.0|10.2|0.0006
71739068|NCT02206035|142990921|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Comparison at Baseline||||0.95
71739069|NCT02206035|142990921|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||Comparison at Day 28||||0.26
71739070|NCT02206035|142990921|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
71739071|NCT02206035|142990921|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Comparison at Day 180||||0.76
71739072|NCT02206035|142990922|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Comparison at Baseline||||0.99
71739073|NCT02206035|142990922|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Comparison at Day 28||||0.48
71739074|NCT02206035|142990922|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
71739075|NCT02206035|142990922|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Comparison at Day 180||||0.96
71739076|NCT02206035|142990923|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison at Baseline||||<0.001
71739077|NCT02206035|142990923|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Comparison at Day 28||||0.75
71739078|NCT02206035|142990923|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Comparison at Day 100||||0.28
71739079|NCT02206035|142990923|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Comparison at Day 180||||0.82
71739080|NCT02206035|142990924|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||Comparison at Baseline||||0.54
71739081|NCT02206035|142990924|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Comparison at Day 28||||0.61
71739082|NCT02206035|142990924|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Comparison at Day 100||||0.42
71739083|NCT02206035|142990924|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Comparison at Day 180||||0.38
71739084|NCT02206035|142990925|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Comparison at Baseline||||0.10
71730250|NCT01719003|142975682|SUPERIORITY_OR_OTHER||Adjusted Mean|-2.26|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.09|-1.43||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c':linear covariate;'treatment','baseline renal function','region','visit' \& 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.||-1.43|-3.09|<0.0001
71730251|NCT02525939|142975684|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.12|TWO_SIDED|95.0|0.75|1.03||The estimated HR was presented with a 95% CI and a p-value. The primary analysis was conducted at the 0.05 significance level.|Stratified Cox proportional hazard model|||A stratified Cox proportional hazards model was used to analyze the primary endpoint. This model included treatment as a main effect, and region and acute coronary syndrome (ACS) index event type as stratification factors. The null and alternative hypotheses tested with the above Cox model were: H0: λ = 1 vs HA: λ ≠ 1, where λ is the, assumed constant, hazard ratio (HR) for the time to occurrence of the composite events of the primary endpoint for the dalcetrapib and placebo treated groups.||1.03|0.75|0.12
71730252|NCT02525939|142975685|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.95|TWO_SIDED|95.0|0.88|1.13|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.13|0.88|0.95
71730253|NCT02525939|142975686|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.27|TWO_SIDED|95.0|0.79|1.07|||Stratified Cox proportional hazard model|||Secondary endpoints were expressed as time to event and an analysis similar to that for the primary endpoint was conducted. In order to control the family-wise Type I error that results from the multiplicity of endpoints, the secondary endpoints were formally tested using the Hochberg's step-up procedure only if the primary analysis results in significant treatment effect at p\<0.05. Otherwise, statistical tests for the secondary endpoints were presented solely for illustrative purposes.||1.07|0.79|0.27
71730254|NCT01735708|142975689|SUPERIORITY|ITT analysis using multiple imputation by chained equation with 50 fully populated data sets.|Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|0.493||0.008|TWO_SIDED|95.0|-2.28|-0.34||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|standard error of difference in means|||-0.34|-2.28|0.008
71730255|NCT01735708|142975690|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.495||0.251|TWO_SIDED|95.0|-1.53|0.4||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.||||0.40|-1.53|0.251
71831277|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9981|TWO_SIDED|95.0|0.79|1.26|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.79|0.9981
71661175|NCT03786718|142835934|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of flu vaccine||||1.00
71661176|NCT03786718|142835934|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of recommended frequency of flu vaccination||||1.00
71661177|NCT03786718|142835935|OTHER|||||||0.15|||||||Wilcoxon Signed Rank Sum test|||||||0.15
71730256|NCT01735708|142975691|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.75||0.844|TWO_SIDED|95.0|-1.32|1.61||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.61|-1.32|0.844
71730257|NCT01735708|142975692|SUPERIORITY|Intent to treat analysis using multiple imputation by chained equations with 50 fully populated data sets.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.836||0.545|TWO_SIDED|95.0|-2.18|1.15||A priori threshold for significance was two-tailed p = .05.|Mixed Models Analysis|Standard errors were based on robust Huber-White variance estimator.|Standard error of difference in means.|||1.15|-2.18|0.545
71730258|NCT04883528|142975693|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
71831278|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5284|TWO_SIDED|95.0|0.74|1.17|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.17|0.74|0.5284
71831279|NCT02528188|143167433|SUPERIORITY||Odds Ratio (OR)|0.89||||0.322|TWO_SIDED|95.0|0.7|1.12|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.12|0.70|0.3220
71831280|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.112|TWO_SIDED|95.0|-0.02|0.2|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.20|-0.02|0.1120
71730259|NCT04883528|142975694|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||||||0.88
71730260|NCT04883528|142975695|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
71730261|NCT04883528|142975696|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.85
71730262|NCT04883528|142975697|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||||||0.80
71730263|NCT04883528|142975698|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71730264|NCT04883528|142975699|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||0.23
71831281|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9686|TWO_SIDED|95.0|-0.11|0.11|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.11|-0.11|0.9686
71831282|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.1589|TWO_SIDED|95.0|-0.25|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.25|0.1589
71730265|NCT04883528|142975700|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|||||||0.95
71730266|NCT04883528|142975701|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71730267|NCT04883528|142975705|SUPERIORITY||Least squares mean difference|-0.01||||0.64|TWO_SIDED|95.0|-0.07|0.04|||Mixed Models Analysis|||||0.04|-0.07|0.64
71730268|NCT04883528|142975706|SUPERIORITY||Least squares mean difference|-7.55||||0.04|TWO_SIDED|95.0|-14.59|0.52|||Mixed Models Analysis|||||0.52|-14.59|0.04
71771873|NCT02129777|143043857|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.365|TWO_SIDED|95.0|-0.5|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.2|-0.5|0.365
71771874|NCT02129777|143043857|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.757|TWO_SIDED|95.0|-0.3|0.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.4|-0.3|0.757
71831283|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.472|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.09|-0.20|0.4720
71831284|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.01|-0.33|0.0320
71831285|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3336|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.24|0.3336
71831286|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09||0.0005|TWO_SIDED|95.0|-0.47|-0.13|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.13|-0.47|0.0005
71831287|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0001|TWO_SIDED|95.0|-0.5|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.16|-0.50|0.0001
71730269|NCT01996592|142975715|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||"PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stress"||||<0.01
71730270|NCT01996592|142975716|OTHER||||||<|0.01||||||p-value was calculated|ANOVA|||||||<0.01
71730271|NCT00394901|142975722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.262||95.0|-0.85|0.23|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.23|-0.85|0.262
71730272|NCT00394901|142975722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86||||0.002||95.0|-1.39|-0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.32|-1.39|0.002
71730273|NCT00394901|142975722|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.019||95.0|-1.15|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.15|0.019
71730274|NCT00394901|142975723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.016||95.0|-1.16|-0.12|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.12|-1.16|0.016
71730275|NCT00394901|142975723|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.008||95.0|-1.14|-0.17|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.17|-1.14|0.008
71730276|NCT00394901|142975724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.1160
71730277|NCT00394901|142975724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0015
71730278|NCT00394901|142975724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0107||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0107
71730279|NCT00394901|142975725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51||||0.038||95.0|-0.99|-0.03|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.99|0.038
71739085|NCT02206035|142990925|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||Comparison at Day 28||||0.32
71739086|NCT02206035|142990925|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Comparison at Day 100||||0.63
71739087|NCT02206035|142990925|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Comparison at Day 180||||0.30
71739088|NCT05173012|142990930|SUPERIORITY||Least Squares (LS) Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.5325|TWO_SIDED|95.0|-0.84|1.62|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 15 mg - placebo.|||1.62|-0.84|0.5325
71739089|NCT05173012|142990930|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.634||0.6549|TWO_SIDED|95.0|-1.54|0.97|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 30 mg - placebo.|||0.97|-1.54|0.6549
71739090|NCT05173012|142990930|SUPERIORITY||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.7||0.1462|TWO_SIDED|95.0|-0.36|2.41|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.|Difference was calculated as Monotherapy: SAGE-324 60 mg - placebo.|||2.41|-0.36|0.1462
71739091|NCT05173012|142990931|SUPERIORITY||LS Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|1.326||0.1271|TWO_SIDED|95.0|0.59|4.67|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||4.67|0.59|0.1271
71739092|NCT05173012|142990931|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.347||0.5642|TWO_SIDED|95.0|-3.45|1.89|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||1.89|-3.45|0.5642
71739093|NCT05173012|142990931|SUPERIORITY||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|1.439||0.486|TWO_SIDED|95.0|-1.84|3.85|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, and timepoint-by-treatment as explanatory variables, treated as fixed effects.||||3.85|-1.84|0.4860
71739094|NCT03668613|142990932|SUPERIORITY||Predicted Log-OR|4.862|||||TWO_SIDED|95.0|3.422|6.782|||Bayesian method using (MAP)|||Compared to historical placebo||6.782|3.422|
71739095|NCT03668613|142990932|SUPERIORITY||Predicted log-OR|4.836|||||TWO_SIDED|95.0|3.422|6.772|||Bayesian method using (MAP)|||Compared to historical placebo||6.772|3.422|
71739096|NCT03668613|142990933|SUPERIORITY||Predicted log -OR|4.292|||||TWO_SIDED|95.0|2.638|6.513|||Bayesian method using (MAP)|||Compared to historical placebo||6.513|2.638|
71739097|NCT03668613|142990933|SUPERIORITY||Predicted log-OR|4.606|||||TWO_SIDED|95.0|2.919|6.78|||Bayesian method using (MAP)|||Compared to historical placebo||6.780|2.919|
71739098|NCT03668613|142990934|SUPERIORITY||Predicted log-OR|4.367|||||TWO_SIDED|95.0|2.916|6.202|||Bayesian method using (MAP)|||||6.202|2.916|
71739099|NCT03668613|142990934|SUPERIORITY||Predicted log-OR|4.709|||||TWO_SIDED|95.0|3.201|6.58|||Bayesian method using (MAP)|||||6.580|3.201|
71739100|NCT00709618|142990944|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.4|55.4|||||The estimated value respresents the percentage of participants with a complete response or a partial response.|||55.4|26.4|
71739101|NCT03781414|142990968|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.0759|||||TWO_SIDED|95.0|-0.0729|0.2165||||||||0.2165|-0.0729|
71739102|NCT03781414|142990968|NON_INFERIORITY|The primary objective would be demonstrated, if the composite efficacy failure rate difference between any of the two CFZ533 arms and the TAC arm is less than the pre-defined non-inferiority margin (0.15) with probability \>80%.|Rate difference|0.1696|||||TWO_SIDED|95.0|0.0072|0.3276||||||||0.3276|0.0072|
71658692|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.17|1.88|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.88|1.17|
71730280|NCT00394901|142975725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
71888887|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.31|TWO_SIDED|95.0|-8.48|2.95||This is the test of the effect modification of viral suppression status|t-test, 2 sided||A negative value indicates a greater treatment difference among those with viral suppression at study entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||2.95|-8.48|0.31
71730281|NCT00394901|142975725|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.72||||0.002||95.0|-1.19|-0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-1.19|0.002
71730282|NCT00394901|142975726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.048||95.0|-0.97|0.0|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.00|-0.97|0.048
71730283|NCT00394901|142975726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.47|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.47|<0.001
71730284|NCT00394901|142975726|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03|||<|0.001||95.0|-1.49|-0.56|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-1.49|<0.001
71730285|NCT00394901|142975727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41||||0.096||95.0|-0.89|0.07|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.07|-0.89|0.096
71730286|NCT00394901|142975727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||<|0.001||95.0|-1.44|-0.48|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.48|-1.44|<0.001
71730287|NCT00394901|142975727|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.46|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.52|-1.46|<0.001
71730288|NCT00394901|142975728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.505||95.0|-2.16|1.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.06|-2.16|0.505
71730289|NCT00394901|142975728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.86||||0.023||95.0|-3.46|-0.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.26|-3.46|0.023
71730290|NCT00394901|142975728|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.012||95.0|-3.56|-0.44|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.44|-3.56|0.012
71730291|NCT00394901|142975729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.349||95.0|-0.91|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.91|0.349
71730292|NCT00394901|142975729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.024||95.0|-1.32|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.32|0.024
71730293|NCT00394901|142975729|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.045||95.0|-1.21|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.01|-1.21|0.045
71730294|NCT00394901|142975730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83||||0.441||95.0|-2.93|1.28|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.28|-2.93|0.441
71730295|NCT00394901|142975730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.55||||0.017||95.0|-4.64|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-4.64|0.017
71730296|NCT00394901|142975730|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61||||0.012||95.0|-4.65|-0.56|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.56|-4.65|0.012
71831288|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.55|<0.0001
71831289|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.30|-0.66|<0.0001
71730297|NCT00394901|142975731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23||||0.47||95.0|-8.28|3.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.83|-8.28|0.470
71730298|NCT00394901|142975731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.04||||0.008||95.0|-14.0|-2.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.06|-14.0|0.008
71730299|NCT00394901|142975731|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.43||||0.013||95.0|-13.3|-1.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-1.59|-13.3|0.013
71730300|NCT00394901|142975732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.178||95.0|-0.48|0.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.09|-0.48|0.178
71730301|NCT00394901|142975732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43||||0.003||95.0|-0.72|-0.15|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-0.72|0.003
71730302|NCT00394901|142975732|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.03||95.0|-0.59|-0.03|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.03|-0.59|0.030
71730303|NCT00394901|142975733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.001||95.0|-1.23|-0.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.30|-1.23|0.001
71730304|NCT00394901|142975733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81||||0.001||95.0|-1.27|-0.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.34|-1.27|0.001
71730305|NCT00394901|142975733|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.4|-0.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.49|-1.40|<0.001
71730306|NCT00394901|142975734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.001||95.0|-14.2|-3.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-3.61|-14.2|0.001
71730307|NCT00394901|142975734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.24||||0.002||95.0|-13.5|-2.99|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-2.99|-13.5|0.002
71730308|NCT00394901|142975734|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.001||95.0|-16.5|-6.22|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-6.22|-16.5|<0.001
71730309|NCT00394901|142975735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.29||||0.245||95.0|-2.95|11.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.54|-2.95|0.245
71730310|NCT00394901|142975735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.95||||0.417||95.0|-4.2|10.11|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.11|-4.20|0.417
71730311|NCT00394901|142975735|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.007||95.0|2.67|16.74|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||16.74|2.67|0.007
71730312|NCT00394901|142975736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.76||95.0|-3.83|5.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.24|-3.83|0.760
71771875|NCT02129777|143043857|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.825|TWO_SIDED|95.0|-0.4|0.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.3|-0.4|0.825
71831290|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0115|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.42|0.0115
71730313|NCT00394901|142975736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.754||95.0|-3.75|5.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.18|-3.75|0.754
71831291|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.26|-0.63|<0.0001
71831292|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.17|-0.56|0.0002
71658693|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.35|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.35|0.91|
71730314|NCT00394901|142975736|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04||||0.641||95.0|-5.43|3.35|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.35|-5.43|0.641
71730315|NCT00394901|142975737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.955||95.0|-0.3|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.32|-0.30|0.955
71730316|NCT00394901|142975737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27||||0.084||95.0|-0.04|0.58|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.58|-0.04|0.084
71730317|NCT00394901|142975737|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.17||95.0|-0.09|0.52|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.52|-0.09|0.170
71730318|NCT00394901|142975738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.01||||0.296||95.0|-3.52|11.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.55|-3.52|0.296
71730319|NCT00394901|142975738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3||||0.007||95.0|2.87|17.73|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.73|2.87|0.007
71730320|NCT00394901|142975738|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.106||95.0|-1.29|13.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.30|-1.29|0.106
71730321|NCT00394901|142975739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.191||95.0|-1.97|9.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.83|-1.97|0.191
71730322|NCT00394901|142975739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.21|||<|0.001||95.0|5.41|17.02|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||17.02|5.41|<0.001
71730323|NCT00394901|142975739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.23|||<|0.001||95.0|8.5|19.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||19.95|8.50|<0.001
71730324|NCT00394901|142975740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03||||0.061||95.0|-8.25|0.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-8.25|0.061
71730325|NCT00394901|142975740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.133||95.0|-7.37|0.98|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.98|-7.37|0.133
71730326|NCT00394901|142975740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.24||95.0|-6.52|1.64|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.64|-6.52|0.240
71730327|NCT00394901|142975741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.68||||0.2842||95.0|0.34|1.37|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||1.37|0.34|0.2842
71730328|NCT00394901|142975741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89||||0.0577||95.0|0.98|3.66|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.66|0.98|0.0577
71730329|NCT00394901|142975741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.1893||95.0|0.81|2.95|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||2.95|0.81|0.1893
71730330|NCT00394901|142975742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.0466
71730331|NCT00394901|142975742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71730332|NCT00394901|142975742|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71730333|NCT00394901|142975743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||0.3440
71730334|NCT00394901|142975743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71730335|NCT00394901|142975743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||||<0.001
71730336|NCT00394901|142975744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.51||||0.057||95.0|-0.1|7.13|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.13|-0.10|0.057
71730337|NCT00394901|142975744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.67||95.0|-2.78|4.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.32|-2.78|0.670
71730338|NCT00394901|142975744|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.04||||0.559||95.0|-2.45|4.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||4.53|-2.45|0.559
71730339|NCT00394901|142975745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.4||||0.004||95.0|3.01|15.78|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||15.78|3.01|0.004
71730340|NCT00394901|142975745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.67||||0.037||95.0|0.39|12.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.95|0.39|0.037
71730341|NCT00394901|142975745|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.46||||0.643||95.0|-4.74|7.66|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.66|-4.74|0.643
71730342|NCT00394901|142975746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.811||95.0|-4.5|5.75|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.75|-4.50|0.811
71730343|NCT00394901|142975746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.07||||0.006||95.0|2.03|12.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.12|2.03|0.006
71730344|NCT00394901|142975746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.03||||0.047||95.0|0.06|10.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.00|0.06|0.047
71730345|NCT00394901|142975747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.013||95.0|1.1|9.5|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.50|1.10|0.013
71730346|NCT00394901|142975747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.82||||0.07||95.0|-0.31|7.96|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.96|-0.31|0.070
71730347|NCT00394901|142975747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.93||||0.058||95.0|-0.13|8.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.00|-0.13|0.058
71730348|NCT00394901|142975748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43||||0.443||95.0|-3.79|8.65|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||8.65|-3.79|0.443
71730349|NCT00394901|142975748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.41||||0.018||95.0|1.28|13.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||13.54|1.28|0.018
71730350|NCT00394901|142975748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.549||95.0|-4.18|7.85|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.85|-4.18|0.549
71730351|NCT00394901|142975749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.15||||0.075||95.0|-0.63|12.92|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.92|-0.63|0.075
71730352|NCT00394901|142975749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41||||0.111||95.0|-1.25|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.08|-1.25|0.111
71831293|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.28|-0.67|<0.0001
71831294|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.18|-0.57|0.0002
71730353|NCT00394901|142975749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.02||||0.366||95.0|-3.55|9.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.60|-3.55|0.366
71730354|NCT00394901|142975750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.64||||0.039||95.0|0.29|11.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||11.00|0.29|0.039
71730355|NCT00394901|142975750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.006||95.0|2.14|12.69|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.69|2.14|0.006
71730356|NCT00394901|142975750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.15||||0.117||95.0|-1.05|9.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||9.34|-1.05|0.117
71730357|NCT00394901|142975751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.99||||0.154||95.0|-1.5|9.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05||9.49|-1.50|0.154
71730358|NCT00394901|142975751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.99||||0.012||95.0|1.58|12.4|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||12.40|1.58|0.012
71730359|NCT00394901|142975751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.76||||0.079||95.0|-0.56|10.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||10.08|-0.56|0.079
71730360|NCT00394901|142975752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.6451||95.0|0.45|3.59|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||3.59|0.45|0.6451
71730361|NCT00394901|142975752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.56||||0.0745||95.0|0.91|7.19|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||7.19|0.91|0.0745
71730362|NCT00394901|142975752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.01||||0.1787||95.0|0.73|5.58|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.58|0.73|0.1787
71730363|NCT00394901|142975753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.0732||95.0|0.93|5.52|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.52|0.93|0.0732
71730364|NCT00394901|142975753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.64||||0.0353||95.0|1.07|6.53|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||6.53|1.07|0.0353
71730365|NCT00394901|142975753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.5||||0.0393||95.0|1.05|5.96|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||5.96|1.05|0.0393
71730366|NCT00394901|142975754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.227||95.0|-0.78|0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.18|-0.78|0.227
71771876|NCT02129777|143043858|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.163||0.931|TWO_SIDED|95.0|-4.48|4.1|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.10|-4.48|0.931
71730367|NCT00394901|142975754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|||<|0.001||95.0|-1.34|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.34|<0.001
71730368|NCT00394901|142975754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||<|0.001||95.0|-1.4|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.40|<0.001
71831295|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.64|-0.25|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.25|-0.64|<0.0001
71658694|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.93|3.74|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.74|1.93|
71658695|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.55|2.63|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.63|1.55|
71658696|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.0|||||TWO_SIDED|95.0|2.21|4.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||4.13|2.21|
71658697|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.07|2.18|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.18|1.07|
71658698|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.36|2.97|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.||2.97|1.36|
71658699|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.73|1.33|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.33|0.73|
71730369|NCT00394901|142975755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.577||95.0|-0.62|0.35|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.35|-0.62|0.577
71730370|NCT00394901|142975755|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.39|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.39|-1.35|<0.001
71730371|NCT00394901|142975755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.27|-1.22|0.002
71730372|NCT00394901|142975756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.275||95.0|-0.75|0.21|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.21|-0.75|0.275
71730373|NCT00394901|142975756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.98|||<|0.001||95.0|-1.46|-0.5|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.50|-1.46|<0.001
71730374|NCT00394901|142975756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.28|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.28|-1.22|0.002
71771877|NCT02129777|143043858|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|STANDARD_ERROR_OF_MEAN|2.143||0.459|TWO_SIDED|95.0|-2.65|5.84|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.84|-2.65|0.459
71661178|NCT03786718|142835936|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in interest in information about how my diabetes health data compares to other patients like me (i.e., social comparison information)||||0.23
71730375|NCT00394901|142975757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.334||95.0|-0.72|0.25|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.25|-0.72|0.334
71771878|NCT02129777|143043858|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.161||0.094|TWO_SIDED|95.0|-0.63|7.93|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.93|-0.63|0.094
71730376|NCT00394901|142975757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.001||95.0|-1.38|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.38|<0.001
71730377|NCT00394901|142975757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66||||0.006||95.0|-1.14|-0.19|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.19|-1.14|0.006
71730378|NCT00394901|142975758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.53||95.0|-0.64|0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.33|-0.64|0.530
71730379|NCT00394901|142975758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
71730380|NCT00394901|142975758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.017||95.0|-1.05|-0.1|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.10|-1.05|0.017
71771879|NCT02129777|143043858|SUPERIORITY_OR_OTHER||LS Mean Difference|2.78|STANDARD_ERROR_OF_MEAN|2.173||0.203|TWO_SIDED|95.0|-1.52|7.09|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.09|-1.52|0.203
71831296|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0238|TWO_SIDED|95.0|-0.44|-0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.03|-0.44|0.0238
71831297|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0011|TWO_SIDED|95.0|-0.55|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.14|-0.55|0.0011
71730381|NCT00394901|142975759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.392||95.0|-0.7|0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.27|-0.70|0.392
71730382|NCT00394901|142975759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.38|-1.35|<0.001
71730383|NCT00394901|142975759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58||||0.016||95.0|-1.06|-0.11|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.11|-1.06|0.016
71730384|NCT00394901|142975760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.364||95.0|-0.71|0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.26|-0.71|0.364
71730385|NCT00394901|142975760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||<|0.001||95.0|-1.39|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.42|-1.39|<0.001
71730386|NCT00394901|142975760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.031||95.0|-1.0|-0.05|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.05|-1.00|0.031
71730387|NCT00394901|142975761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.326||95.0|-0.73|0.24|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.24|-0.73|0.326
71730388|NCT00394901|142975761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.43|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.46|-1.43|<0.001
71888888|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.72|TWO_SIDED|95.0|-4.29|5.95||This is the test of effect modification by QIDS-SR depression level at study entry.|t-test, 2 sided||A positive value indicates a greater treatment difference among those with moderate levels of depression compared to severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups.Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.95|-4.29|0.72
71888889|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.91|TWO_SIDED|95.0|-5.91|5.31||This is the test of effect modification by mode of transmission|t-test, 2 sided||A negative value would indicate a greater treatment difference for those with perinatal HIV acquisition compared to behavioral acquisition.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||5.31|-5.91|0.91
71888890|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.57|TWO_SIDED|95.0|-3.91|6.57||This is the test of effect modification by HIV CDC stage level|t-test, 2 sided||A positive value would indicate a greater treatment effect for those with less than HIV CDC Stage 3 compared to those with CDC Stage 3 HIV illness.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||6.57|-3.91|0.57
71888891|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|5.93||||0.1|TWO_SIDED|95.0|-1.73|13.59||This is the test of effect modification of CD4 Stage 3 at entry.|t-test, 2 sided||A positive value indicates a greater treatment effect among those with less than Stage 3 CD4 count at entry compared to those with Stage 3 CD4 count.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups..||13.59|-1.73|0.10
71888892|NCT02939131|143298771|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.58|TWO_SIDED|95.0|-7.74|4.6||This is the test of effect modification by Nadir Stage 3 level at study entry.|t-test, 2 sided||A negative value indicates a greater treatment effect among those with Stage 3 Nadir CD4 compare to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences.This is equivalent to taking the differences of the treatment effects between subgroups. Note: For QIDS-SR, since a lower score reflects fewer depression symptoms, a positive treatment effect is a negative difference value between groups.||4.60|-7.74|0.58
71658700|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.42|2.5|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.50|1.42|
71658701|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.43|2.2|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.20|1.43|
71730389|NCT00394901|142975761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65||||0.007||95.0|-1.13|-0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.18|-1.13|0.007
71730390|NCT00394901|142975762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.241||95.0|-0.78|0.2|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.20|-0.78|0.241
71730391|NCT00394901|142975762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.001||95.0|-1.34|-0.37|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.37|-1.34|0.001
71730392|NCT00394901|142975762|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63||||0.01||95.0|-1.1|-0.15|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.15|-1.10|0.010
71730393|NCT00394901|142975763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27||||0.281||95.0|-0.76|0.22|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||0.22|-0.76|0.281
71831298|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0064|TWO_SIDED|95.0|-0.51|-0.08|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.08|-0.51|0.0064
71831299|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.11||0.0025|TWO_SIDED|95.0|-0.54|-0.12|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.12|-0.54|0.0025
71831300|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0589|TWO_SIDED|95.0|-0.48|0.01|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.01|-0.48|0.0589
71831301|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.018|TWO_SIDED|95.0|-0.53|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||-0.05|-0.53|0.0180
71831302|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.0944|TWO_SIDED|95.0|-0.47|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.04|-0.47|0.0944
71771880|NCT02129777|143043859|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.7||0.448|TWO_SIDED|95.0|-1.92|0.86|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.86|-1.92|0.448
71771881|NCT02129777|143043859|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.692||0.099|TWO_SIDED|95.0|-2.53|0.22|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.22|-2.53|0.099
71771882|NCT02129777|143043859|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.69||0.396|TWO_SIDED|95.0|-1.96|0.78|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.78|-1.96|0.396
71771883|NCT02129777|143043859|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.697||0.102|TWO_SIDED|95.0|-2.54|0.23|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.23|-2.54|0.102
71771884|NCT02129777|143043860|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.626||0.099|TWO_SIDED|95.0|-2.29|-0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.20|-2.29|0.099
71888893|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|-67.81||||0.01|TWO_SIDED|95.0|-116.53|-19.1||This is the test of effect modification by sex at birth.|t-test, 2 sided||A negative value indicates a greater treatment response (higher percent with response in COMB-R than in ESC group) among females compared to males.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||-19.10|-116.53|0.01
71888894|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|43.08||||0.09|TWO_SIDED|95.0|-8.23|94.38||This is the test of effect modification by age group.|t-test, 2 sided||A positive value reflects a greater treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.38|-8.23|0.09
71661179|NCT03786718|142835936|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in interest in information about how their diabetes health data compares to the goal range (i.e., goal-based comparison information)||||1.00
71730394|NCT00394901|142975763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.33|-1.30|0.001
71730395|NCT00394901|142975763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62||||0.012||95.0|-1.09|-0.14|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.||-0.14|-1.09|0.012
71730396|NCT05028517|142975777|SUPERIORITY||ANOVA Omnibus F test|0.511||||0.602|TWO_SIDED||||||ANOVA|||||||.602
71661180|NCT03786718|142835936|OTHER|||||||0.51|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to other patients like me \[social comparison information\] is useful.'||||0.51
71730397|NCT05028517|142975778|SUPERIORITY||ANOVA Omnibus F test|1.245||||0.294|TWO_SIDED||||||ANOVA|||||||.294
71730398|NCT05028517|142975779|SUPERIORITY||Anova Omnibus F test|2.585||||0.039|TWO_SIDED||||||ANOVA|||||||.039
71730399|NCT05028517|142975780|SUPERIORITY||Anova Omnibus F test|2.723||||0.032|TWO_SIDED||||||ANOVA|||||||0.032
71730400|NCT05028517|142975781|SUPERIORITY||Anova Omnibus F test|0.588||||0.672|TWO_SIDED||||||ANOVA|||||||0.672
71730401|NCT05028517|142975782|SUPERIORITY||Anova Omnibus F test|2.612||||0.038|TWO_SIDED||||||ANOVA|||||||0.038
71730402|NCT05028517|142975783|SUPERIORITY||Anova Omnibus F test|0.196||||0.94|TWO_SIDED||||||ANOVA|||||||.940
71730403|NCT05028517|142975784|SUPERIORITY||Anova Omnibus F test|0.59||||0.671|TWO_SIDED||||||ANOVA|||||||.671
71730404|NCT05028517|142975785|SUPERIORITY||Anova Omnibus F test|0.896||||0.468|TWO_SIDED||||||ANOVA|||||||.468
71730405|NCT05028517|142975786|SUPERIORITY||Anova Omnibus F test|3.42||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71730406|NCT05028517|142975787|SUPERIORITY||Anova Omnibus F test|1.384||||0.257|TWO_SIDED||||||ANOVA|||||||.257
71730407|NCT05028517|142975788|SUPERIORITY||Anova Omnibus F test|1.686||||0.192|TWO_SIDED||||||ANOVA|||||||.192
71730408|NCT05028517|142975789|SUPERIORITY||Anova Omnibus F test|0.651||||0.524|TWO_SIDED||||||ANOVA|||||||.524
71730409|NCT05028517|142975790|SUPERIORITY||Anova Omnibus F test|1.32||||0.255|TWO_SIDED||||||ANOVA|||||||.255
71730410|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
71771885|NCT02129777|143043860|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.619||0.045|TWO_SIDED|95.0|-2.49|-0.03|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||-0.03|-2.49|0.045
71730411|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
71730412|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0313
71730413|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
71730414|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
71730415|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0156
71730416|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0078
71730417|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.1563||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.1563
71730418|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.4375||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.4375
71730419|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0781
71730420|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.||||0.0371
71730421|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0137
71730422|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0547
71730423|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.0488
71730424|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.3594
71730425|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0488||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.0488
71730426|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.1055||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.1055
71730427|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.9102||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.9102
71730428|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.1934
71730429|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.1641
71730430|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0137||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0137
71730431|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
71730432|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
71730433|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
71730434|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0547||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.0547
71730435|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0195||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0195
71730436|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0059
71730437|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.5703
71730438|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
71730439|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0039
71730440|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole body, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.||||0.0039
71730441|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.5703||95.0||||p-value is for whole body, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.||||0.5703
71730442|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for whole body, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.||||0.0273
71730443|NCT00259298|142975795|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value if for whole body, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.||||0.0039
71730444|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for whole skeleton, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.||||0.0098
71730445|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for whole skeleton, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.||||0.0039
71730446|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for whole skeleton, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.||||0.6523
71730447|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||p-value is for whole skeleton, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.||||0.1641
71888895|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.93|TWO_SIDED|95.0|-51.13|55.49||This is the test of effect modification by viral suppression status.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with suppressed viral status at entry compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||55.49|-51.13|0.93
71888896|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|3.36||||0.87|TWO_SIDED|95.0|-42.28|49.0||This is the test of effect modification by entry QIDS-SR depression level.|t-test, 2 sided||A positive value would indicate a greater treatment response for those with severe depressive symptoms at study entry compared to those with moderate depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||49.00|-42.28|0.87
71730448|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for whole skeleton, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.||||0.0078
71730449|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.||||0.0078
71730450|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.||||0.0078
71730451|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.||||0.0781
71730452|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.||||0.0078
71730453|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0156||95.0||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.||||0.0156
71730454|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0391||95.0||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.||||0.0391
71730455|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0313||95.0||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.||||0.0313
71771886|NCT02129777|143043860|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.62||0.118|TWO_SIDED|95.0|-2.21|0.25|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.25|-2.21|0.118
71771887|NCT02129777|143043860|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.616||0.05|TWO_SIDED|95.0|-2.44|0.0|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.00|-2.44|0.050
71771888|NCT02129777|143043861|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.503||0.211|TWO_SIDED|95.0|-1.63|0.36|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.36|-1.63|0.211
71771889|NCT02129777|143043861|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.497||0.087|TWO_SIDED|95.0|-1.85|0.13|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.13|-1.85|0.087
71730456|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.2969||95.0||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.||||0.2969
71831303|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1198|TWO_SIDED|95.0|-0.45|0.05|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.05|-0.45|0.1198
71730457|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.5625||95.0||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.||||0.5625
71730458|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0469||95.0||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.||||0.0469
71730459|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.||||0.1934
71730460|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.||||0.2324
71730461|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.||||0.0645
71730462|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.||||0.0273
71730463|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.||||0.7344
71730464|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.||||0.1934
71730465|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.7695||95.0||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.||||0.7695
71730466|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.||||0.6523
71730467|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.2324||95.0||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.||||0.2324
71730468|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.6523||95.0||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.||||0.6523
71730469|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.||||0.0098
71730470|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.||||0.0020
71730471|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0039||95.0||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.||||0.0039
71730472|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.||||0.0273
71730473|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.3594||95.0||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.||||0.3594
71730474|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0371||95.0||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.||||0.0371
71730475|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0098||95.0||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.||||0.0098
71730476|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.4609||95.0||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.||||0.4609
71730477|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.1934||95.0||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.||||0.1934
71730478|NCT00259298|142975796|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.||||0.0273
71730479|NCT00259298|142975797|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.||||1.0
71730480|NCT00259298|142975797|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for focal change, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.||||1.0
71730481|NCT00259298|142975799|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for change at 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.||||0.0020
71730482|NCT02360293|142975807|SUPERIORITY||Slope|1.88|STANDARD_ERROR_OF_MEAN|46.2|||TWO_SIDED|95.0|-119.0|122.7|||||Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.||122.7|-119.0|
71730483|NCT02360293|142975808|SUPERIORITY||Slope|-5.02|STANDARD_ERROR_OF_MEAN|56.7|||TWO_SIDED|95.0|-15.85|5.81|||||Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||5.81|-15.85|
71730484|NCT02360293|142975809|SUPERIORITY||Slope|-1.162|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.969|0.646|||||Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.646|-2.969|
71730485|NCT02360293|142975810|SUPERIORITY||Slope|-0.345|STANDARD_ERROR_OF_MEAN|0.267|||TWO_SIDED|95.0|-1.044|0.353|||||"Estimate generated through ANCOVA predicting Pain In Past Week as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.."|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.||0.353|-1.044|
71730486|NCT03734029|142975828|SUPERIORITY||Cox Proportional Hazard|0.5085|||<|0.0001|TWO_SIDED|95.0|0.4012|0.6444||Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.|Log Rank|||||0.6444|0.4012|<0.0001
71730487|NCT00316524|142975840|NON_INFERIORITY|The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates|Difference in seroconversion rates (%)|-3.4|||||ONE_SIDED|97.5|-7.36||||||||||-7.36|
71730488|NCT00131456|142975858|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Regression, Logistic|||Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.||||<0.01
71730489|NCT00262847|142975859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.448||95.0|0.844|1.078|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.078|0.844|0.448
71730490|NCT00262847|142975859|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.765|||<|0.001||95.0|0.676|0.866|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||0.866|0.676|<0.001
71771890|NCT02129777|143043861|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.494||0.58|TWO_SIDED|95.0|-1.26|0.71|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.71|-1.26|0.580
71771891|NCT02129777|143043861|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.496||0.873|TWO_SIDED|95.0|-1.06|0.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.90|-1.06|0.873
71730491|NCT00262847|142975860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.069||||0.41||95.0|0.912|1.255|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.255|0.912|0.410
71730492|NCT00262847|142975860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.131||95.0|0.746|1.039|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.||||1.039|0.746|0.131
71730493|NCT03880838|142975871|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.391
71730494|NCT03880838|142975871|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.861|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.861
71730495|NCT03880838|142975871|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.01||0.835|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.835
71730496|NCT03880838|142975871|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.877|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.877
71730497|NCT03880838|142975871|SUPERIORITY||Slope|0.004|STANDARD_ERROR_OF_MEAN|0.01||0.969|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.969
71730498|NCT03880838|142975871|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.893
71730499|NCT03880838|142975871|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.689|TWO_SIDED||||||Regression, Linear|||In this contrast, In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.689
71730500|NCT03880838|142975871|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.427|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.427
71730501|NCT03880838|142975871|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.504|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.504
71730502|NCT03880838|142975871|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.893|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.893
71730503|NCT03880838|142975871|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.918|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.918
71730504|NCT03880838|142975871|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.755|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.755
71771892|NCT02129777|143043862|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|6.7||0.803|TWO_SIDED|95.0|-15.2|11.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||11.8|-15.2|0.803
71771893|NCT02129777|143043862|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|6.73||0.248|TWO_SIDED|95.0|-5.7|21.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||21.4|-5.7|0.248
71771894|NCT02129777|143043862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|6.67||0.914|TWO_SIDED|95.0|-12.7|14.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.2|-12.7|0.914
71730505|NCT03880838|142975871|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.858|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.858
71730506|NCT03880838|142975872|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46||0.436|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.436
71730507|NCT03880838|142975872|SUPERIORITY||Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.45||0.539|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.539
71730508|NCT03880838|142975872|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.66||0.994|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.994
71730509|NCT03880838|142975872|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.66||0.7|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.700
71730510|NCT03880838|142975872|SUPERIORITY||Slope|0.75|STANDARD_ERROR_OF_MEAN|0.66||0.258|TWO_SIDED||||||Regression, Logistic|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.258
71661181|NCT03786718|142835936|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in agreement with statement: 'Information about how my diabetes health data compares to the goals range \[goal-based comparison information\] is useful.||||0.63
71661182|NCT03786718|142835937|OTHER|||||||0.01|||||||Wilcoxon Signed Rank Sum test|||||||0.01
71730511|NCT03880838|142975872|SUPERIORITY||Slope|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.428|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.428
71661183|NCT00368979|142835938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.003||95.0|-2.7|-0.5|||ANCOVA|||||-0.5|-2.7|0.003
71730512|NCT03880838|142975872|SUPERIORITY||Slope|-0.48|STANDARD_ERROR_OF_MEAN|0.62||0.434|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.434
71661184|NCT00945100|142835946|SUPERIORITY_OR_OTHER||Risk difference (unadjusted)|22.0||||0.003|TWO_SIDED|95.0|8.0|35.0|||Regression, Logistic|The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||35|8|0.003
71730513|NCT03880838|142975872|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.62||0.228|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.228
71730514|NCT03880838|142975872|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.674|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.674
71730515|NCT03880838|142975872|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.61||0.799|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.799
71730516|NCT03880838|142975872|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.61||0.794|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.794
71730517|NCT03880838|142975872|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.871|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.871
71730518|NCT03880838|142975872|SUPERIORITY||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.62||0.139|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.139
71730519|NCT03880838|142975873|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.357|TWO_SIDED||||||Regression, Linear|||In this contrast, letter was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.357
71730520|NCT03880838|142975873|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.28||0.294|TWO_SIDED||||||Regression, Linear|||In this contrast, no contact control was compared against all other conditions (coded into one category and set as the reference group). The key outcome is the interaction between conditions and time (2019 as the reference group).||||.294
71730521|NCT03880838|142975873|SUPERIORITY||Slope|-0.28|STANDARD_ERROR_OF_MEAN|0.4||0.496|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.496
71730522|NCT03880838|142975873|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.4||0.722|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.722
71730523|NCT03880838|142975873|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.445|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against no nudge conditions (coded into one category and set as the reference group).||||.445
71730524|NCT03880838|142975873|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.38||0.531|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.531
71730525|NCT03880838|142975873|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.177|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.177
71730526|NCT03880838|142975873|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.38||0.314|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.314
71730527|NCT03880838|142975873|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.38||0.85|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the letter condition (set as the reference group).||||.850
71771895|NCT02129777|143043862|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|6.74||0.523|TWO_SIDED|95.0|-9.2|17.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||17.9|-9.2|0.523
71730528|NCT03880838|142975873|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.37||0.391|TWO_SIDED||||||Regression, Linear|||In this contrast, no nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.391
71730529|NCT03880838|142975873|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.37||0.906|TWO_SIDED||||||Regression, Linear|||In this contrast, prevention conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.906
71730530|NCT03880838|142975873|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.37||0.635|TWO_SIDED||||||Regression, Linear|||In this contrast, commitment conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||.635
71730531|NCT03880838|142975873|SUPERIORITY||Slope|0.63|STANDARD_ERROR_OF_MEAN|0.37||0.093|TWO_SIDED||||||Regression, Linear|||In this contrast, both nudge conditions (coded into one category) were compared against the no contact condition (set as the reference group).||||0.093
71730532|NCT02209948|142975895|OTHER|Log Rank (Mantel-Cox)||||||0.943||||||Threshold P-value of 0.05|Log Rank|||||||0.943
71730533|NCT02209948|142975896|OTHER||Hazard Ratio (HR)|1.3||||0.16|TWO_SIDED|95.0|0.9|1.88||Threshold of significance P-value 0.05|Regression, Cox|||||1.88|0.90|0.16
71730534|NCT02209948|142975897|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.65|1.5||Threshold for significance P-value 0.05|Regression, Cox|||||1.5|0.65|0.99
71730535|NCT02209948|142975898|OTHER||Hazard Ratio (HR)|1.45||||0.13|TWO_SIDED|95.0|0.89|2.33||threshold for significance 0.05|Regression, Cox|||||2.33|0.89|0.13
71730536|NCT00289198|142975903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.256|||<|0.001|TWO_SIDED|95.0|-1.73|-0.78||Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate|ANCOVA|||||-0.78|-1.73|<0.001
71730537|NCT00289198|142975904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.459|||<|0.001|TWO_SIDED|95.0|-1.93|-0.99||Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate|ANCOVA|||||-0.99|-1.93|<0.001
71730538|NCT00289198|142975905|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|Based on logistic regression adjusting for age, gender and country||||||<0.001
71730539|NCT00289198|142975906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|||<|0.001|TWO_SIDED|95.0|-1.74|-0.81|||ANCOVA|||||-0.81|-1.74|<0.001
71730540|NCT00289198|142975907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.291|||<|0.001|TWO_SIDED|95.0|-1.77|-0.81|||ANCOVA|||||-0.81|-1.77|<0.001
71730541|NCT00289198|142975908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.118|||<|0.001|TWO_SIDED|95.0|-20.03|-8.21|||ANCOVA|||||-8.21|-20.03|<0.001
71730542|NCT00289198|142975909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.033|||<|0.001|TWO_SIDED|95.0|-27.13|-12.94|||ANCOVA|||||-12.94|-27.13|<0.001
71730543|NCT00289198|142975910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.41|-0.14|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.14|-0.41|<0.001
71730544|NCT00289198|142975910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Nasal Congestion, Placebo vs Fluticasone furoate||-0.14|-0.42|<0.001
71730545|NCT00289198|142975910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.331|||<|0.001|TWO_SIDED|95.0|-0.47|-0.2|||ANCOVA|||Nasal Itching, Placebo vs Fluticasone furoate||-0.20|-0.47|<0.001
71730546|NCT00289198|142975910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.52|-0.27|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.27|-0.52|<0.001
71730547|NCT00289198|142975911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357||||0.001|TWO_SIDED|95.0|-0.5|-0.22|||ANCOVA|||Rhinorrhea score, Placebo versus fluticasone furoate||-0.22|-0.50|0.001
71730548|NCT00289198|142975911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.001|TWO_SIDED|95.0|-0.51|-0.23|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.23|-0.51|0.001
71730549|NCT00289198|142975911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
71661185|NCT00945100|142835947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.01|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|The ANCOVA model included interocular difference at randomization as an adjustment covariate.||||1.0|0.1|0.01
71730550|NCT00289198|142975911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.372||||0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.24|-0.50|0.001
71730551|NCT00289198|142975912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.281||||0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Rhinorrhea score,Placebo versus fluticasone furoate||-0.14|-0.42|0.001
71730552|NCT00289198|142975912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.314||||0.001|TWO_SIDED|95.0|-0.45|-0.17|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate||-0.17|-0.45|0.001
71730553|NCT00289198|142975912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.324||||0.001|TWO_SIDED|95.0|-0.45|-0.19|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate||-0.19|-0.45|0.001
71730554|NCT00289198|142975912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374||||0.001|TWO_SIDED|95.0|-0.5|-0.25|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate||-0.25|-0.50|0.001
71730555|NCT00289198|142975913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.292|||<|0.001||95.0|-0.43|-0.15|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate||-0.15|-0.43|<0.001
71730556|NCT00289198|142975913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.264|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||ANCOVA|||Nasal Congestion score, Placebo vs Fluticasone furoate||-0.12|-0.40|<0.001
71730557|NCT00289198|142975913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|||<|0.001|TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA|||Nasal Itching score, Placebo vs Fluticasone furoate||-0.20|-0.48|<0.001
71730558|NCT00289198|142975913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|||<|0.001|TWO_SIDED|95.0|-0.54|-0.28|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate||-0.28|-0.54|<0.001
71730559|NCT00289198|142975914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.506||||0.004|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|||||-0.16|-0.85|0.004
71730560|NCT00289198|142975915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.491||||0.007||95.0|-0.85|-0.13|||ANCOVA|||||-0.13|-0.85|0.007
71730561|NCT00289198|142975916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.531||||0.003|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||||-0.19|-0.88|0.003
71730562|NCT00289198|142975917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496||||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||||-0.15|-0.84|0.005
71730563|NCT00289198|142975918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.216||||0.001|TWO_SIDED|95.0|-0.34|-0.09|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.09|-0.34|0.001
71730564|NCT00289198|142975918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.137||||0.028|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye tearing/watering score, Placebo vs fluticasone furoate||-0.02|-0.26|0.028
71730565|NCT00289198|142975918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.156||||0.01|TWO_SIDED|95.0|-0.27|-0.04|||ANCOVA|||Eye redness, Placebo vs fluticasone furoate||-0.04|-0.27|0.010
71730566|NCT00289198|142975919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate||-0.08|-0.35|0.002
71730567|NCT00289198|142975919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.016||95.0|-0.29|-0.03|||ANCOVA|||Eye tearing or watering, Placebo vs fluticasone furoate||-0.03|-0.29|0.016
71831304|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1837|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1837
71658702|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.17|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.17|
71661186|NCT00945100|142835949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.002|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||1.0|0.3|0.002
71831305|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.13||0.317|TWO_SIDED|95.0|-0.39|0.13|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.13|-0.39|0.3170
71730568|NCT00289198|142975919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.076|TWO_SIDED|95.0|-0.24|-0.01|||ANCOVA|||Eye redness score, Placebo vs fluticasone furoate||-0.01|-0.24|0.076
71730569|NCT00289198|142975920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.211||||0.001|TWO_SIDED|95.0|-0.34|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs Fluticasone furoate||-0.08|-0.34|0.001
71730570|NCT00289198|142975920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145||||0.023|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Eye tearing/watering, Placebo vs Fluticasone furoate||-0.02|-0.27|0.023
71730571|NCT00289198|142975920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.005|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||Eye Redness score, Placebo vs Fluticasone furoate||-0.05|-0.30|0.005
71730572|NCT00289198|142975921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.223||||0.001|TWO_SIDED|95.0|-0.35|-0.09|||ANCOVA|||Eye itching/burning, Placebo vs fluticasone furoate||-0.09|-0.35|0.001
71730573|NCT00289198|142975921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.04|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Eye Tearing/Watering score, Placebo vs fluticasone furoate||-0.01|-0.25|0.040
71730574|NCT00289198|142975921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142||||0.022|TWO_SIDED|95.0|-0.26|-0.02|||ANCOVA|||Eye Redness score, Placebo vs fluticasone furoate||-0.02|-0.26|0.022
71730575|NCT00289198|142975922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.376||||0.004|TWO_SIDED|95.0|2.71|14.04|||ANCOVA|||||14.04|2.71|0.004
71730576|NCT00289198|142975923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.28||||0.002|TWO_SIDED|95.0|3.52|15.04|||ANCOVA|||||15.04|3.52|0.002
71730577|NCT00289198|142975924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.638||||0.009|TWO_SIDED|95.0|1.89|13.39|||ANCOVA|||||13.39|1.89|0.009
71730578|NCT02406443|142975940|SUPERIORITY||Mean Difference (Final Values)|46.0|||=|0.012|TWO_SIDED||||||Regression, Linear|||||||=0.012
71730579|NCT02406443|142975941|SUPERIORITY||Median Difference (Final Values)|5.7||||0.4|TWO_SIDED||||||Regression, Linear|||||||0.40
71730580|NCT02406443|142975942|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.15|TWO_SIDED||||||Regression, Linear|||||||0.15
71730581|NCT02406443|142975943|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71730582|NCT02406443|142975944|SUPERIORITY||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71730583|NCT02406443|142975945|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
71730584|NCT01062061|142975948|SUPERIORITY_OR_OTHER|||||||0.9733||95.0|||||Chi-squared|||||||0.9733
71730585|NCT01062061|142975949|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Chi-squared|||||||0.0001
71730586|NCT03180398|142975991|SUPERIORITY|It was hoped to compare radiomics features, using non-parametric tests, but this was not possible because of the small number of patients accrued.|||||||||||||||||Not enough patients were accrued for radiomics analysis. PI left institution and country. Analysis could not be completed.|||
71771896|NCT02129777|143043863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.37||0.978|TWO_SIDED|95.0|-2.7|2.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||2.8|-2.7|0.978
71831306|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1873|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.08|-0.43|0.1873
71831307|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.5719|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.18|-0.33|0.5719
71730587|NCT03180398|142975992|OTHER|Analysis could not be completed.|||||||||||||||||PI left institution and country. Analysis could not be completed.|||
71730588|NCT01605227|142976009|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.213|TWO_SIDED|95.0|0.76|1.06|||Log Rank|The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||1.06|0.76|0.213
71730589|NCT01605227|142976010|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.||||||<0.001
71730590|NCT01605227|142976011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.4|0.57|||Log Rank|The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.||||0.57|0.40|<0.001
71730591|NCT03093974|142976012|SUPERIORITY|The number of NCFB pulmonary exacerbations was compared between treatment groups using a negative binomial model including treatment, pooled site (country) and baseline use of stable concomitant therapy with oral macrolides as fixed effects and log-time on treatment as an offset.|LS Mean rate ratio|0.612||||0.00101|TWO_SIDED|95.0|0.457|0.82|||two-sided Wald chi-square test|||||0.820|0.457|0.00101
71730592|NCT00700102|142976072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0062|TWO_SIDED|95.0|0.69|0.94|||Log Rank|||||0.94|0.69|0.0062
71730593|NCT00700102|142976073|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1713|TWO_SIDED|95.0|0.77|1.05|||Log Rank|||Kaplan Meier Estimate||1.05|0.77|0.1713
71730594|NCT00700102|142976075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.59|0.78|||Log Rank|||||0.78|0.59|<.0001
71730595|NCT00700102|142976076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.3113|TWO_SIDED|95.0|-1.5|4.5|||Chi-squared|||||4.5|-1.5|0.3113
71730596|NCT00700102|142976076|SUPERIORITY_OR_OTHER|||||||0.4315|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4315
71730597|NCT01811303|142976078|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71730598|NCT01811303|142976078|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.016||95.0|||||ANOVA|||||||<0.016
71831308|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.3571|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.14|-0.39|0.3571
71730599|NCT00762996|142976100|NON_INFERIORITY_OR_EQUIVALENCE|"margin +/- 0.5 logMar lines~The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark.~logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal."|Mean Difference (Final Values)|0.005287|STANDARD_ERROR_OF_MEAN|0.00976||||95.0|-0.01389|0.2447|||Mixed Models Analysis||logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.|Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.||0.2447|-0.01389|
71831309|NCT02528188|143167434|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9072|TWO_SIDED|95.0|-0.25|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.||0.28|-0.25|0.9072
71730600|NCT00762996|142976101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4757|STANDARD_ERROR_OF_MEAN|0.2505||||95.0|0.05563|0.4757|||Mixed Models Analysis||Mean difference is etafilcon A minus omafilcon A.|||0.4757|0.05563|
71730601|NCT02084238|142976116|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparing the data between baseline and week 10.||||<0.01
71730602|NCT00320372|142976121|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|38.1|||||TWO_SIDED|95.0|36.3|39.9|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||39.9|36.3|
71730603|NCT00320372|142976121|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|17.0|||||TWO_SIDED|95.0|15.2|19.0|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||19.0|15.2|
71730604|NCT00320372|142976121|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
71730605|NCT00320372|142976122|SUPERIORITY_OR_OTHER|||||||0.1015|TWO_SIDED|||||Comparison for Kaplan Meier Median Time until recurrence|Log Rank|Null hypothesis: median TUR between 2 groups is not different. Alternate hypothesis: median TUR between 2 groups is different.||||||0.1015
71730606|NCT00320372|142976123|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|19.8|||||TWO_SIDED|95.0|18.4|21.3|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||21.3|18.4|
71730607|NCT00320372|142976123|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|8.1|||||TWO_SIDED|95.0|6.9|9.5|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.||9.5|6.9|
71730608|NCT00320372|142976123|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.||||<.0001
71730609|NCT00320372|142976129|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.34997|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<0.0001
71730610|NCT00320372|142976130|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||3 Month Time point||||<.0001
71730611|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||6 Month Time point||||.0068
71730612|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||9 Month Time point||||.0008
71730613|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||12 Month Time point||||.0003
71730614|NCT00320372|142976130|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||18 Month Time point||||<.0001
71730615|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||24 Month Time point||||.0059
71730616|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0028|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||30 Month Time point||||.0028
71730617|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||36 Month Time point||||.0002
71730618|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0051|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||42 Month Time point||||.0051
71730619|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0363|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||48 Month Time point||||.0363
71831310|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09||0.0004|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.49|0.0004
71831311|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.09||0.0134|TWO_SIDED|95.0|-0.4|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.40|0.0134
71730620|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||54 Month Time point||||.0048
71730621|NCT00320372|142976130|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||60 Month Time point||||.0009
71730622|NCT00320372|142976130|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|12.1009|||||TWO_SIDED|95.0|10.8979|13.3039|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||13.3039|10.8979|
71730623|NCT00320372|142976130|SUPERIORITY_OR_OTHER||MMRM Least Squares Mean|7.5964|||||TWO_SIDED|95.0|6.1327|9.0602|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||9.0602|6.1327|
71730624|NCT00320372|142976130|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."||||<.0001
71888897|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|41.65||||0.17|TWO_SIDED|95.0|-21.91|105.2||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would indicate a larger treatment response for those with perinatal transmission compared to behavioral.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||105.20|-21.91|0.17
71888898|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|49.4||||0.17|TWO_SIDED|95.0|-26.02|124.83||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value reflects a greater treatment response for those with HIV CDC Stage 3 classification compared to those with CDC classification less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||124.83|-26.02|0.17
71730625|NCT00320372|142976131|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14837|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
71730626|NCT00320372|142976132|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.14819|||<|0.0001|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture.~Alternate hypothesis: There is no correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||<.0001
71730627|NCT00320372|142976133|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficients|0.04625||||0.0012|TWO_SIDED|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.||||.0012
71730628|NCT00086502|142976172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.73|<|0.001||95.0|-0.85|-0.54||"Model terms: treatment; baseline; prior antihyperglycemic~agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]"|ANCOVA|||||-0.54|-0.85|<0.001
71730629|NCT00086502|142976173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7|STANDARD_DEVIATION|30.9|<|0.001||95.0|-24.3|-11.0||Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy \[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\]|ANCOVA|||||-11.0|-24.3|<0.001
71730630|NCT01304329|142976174|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.05|STANDARD_DEVIATION|5.4|||TWO_SIDED|90.0|98.9|105.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|Considered characteristic is empa plus simvastatin divided by empa alone||105.29|98.90|
71730631|NCT01304329|142976175|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.26|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|80.06|128.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin~Considered characteristic is empa plus simvastatin divided by simvastatin alone"||128.07|80.06|
71730632|NCT01304329|142976175|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|104.87|STANDARD_DEVIATION|25.5|||TWO_SIDED|90.0|90.09|122.07|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||122.07|90.09|
71730633|NCT01304329|142976176|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|109.49|STANDARD_DEVIATION|21.1|||TWO_SIDED|90.0|96.91|123.69|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone||123.69|96.91|
71730634|NCT01304329|142976177|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.18|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|76.3|123.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||123.77|76.30|
71658703|NCT00546572|142832795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 1.|ratio of geometric mean titer|3.7|||||TWO_SIDED|95.0|2.69|5.09|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.09|2.69|
71658704|NCT00546572|142832796|SUPERIORITY_OR_OTHER||difference in proportions|43.8|||||TWO_SIDED|95.0|37.4|49.9|||||Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC - 23vPS expressed as a percentage.|"Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was \> 0."||49.9|37.4|
71658705|NCT00546572|142832797|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|9.6|||||TWO_SIDED|95.0|7.0|13.26|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|"Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||13.26|7.00|
71730635|NCT01304329|142976177|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.27|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|84.9|111.44|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"Cmax of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||111.44|84.90|
71730636|NCT01304329|142976178|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.52|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|99.1|106.06|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone.||106.06|99.10|
71730637|NCT01304329|142976179|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.34|STANDARD_DEVIATION|41.7|||TWO_SIDED|90.0|80.39|130.29|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||130.29|80.39|
71730638|NCT01304329|142976179|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|111.25|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|95.93|129.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|"AUC of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."||129.02|95.93|
71730639|NCT02575118|142976185|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||In one saliva sample collected before treatment, the BPA concentration was more than 100 times higher (11.6 ng/ml) than the mean value and more than 100 SD from the mean of the remaining 19 samples. This saliva sample was excluded from the statistical analysis because it was probably contaminated. One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points) were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
71730640|NCT02575118|142976186|OTHER||||||<|0.05|||||||linear mixed-effects regression models|All available data, and hence data for participants with missing observations at some time points, were included in the model.||One participant had breakfast before the sample time point 1 wk after treatment, and thus the samples collected from this participant at this time point were not included in the statistical analysis.|We used mixed effects models and all available data (also data for participants with missing observations at some time points), were included in the model. Using mixed effects models is a recognized method when there are missing data. Thus, data from all 20 individuals were used for estimations at all time points (see: Rabe-Hesketh and Skrondal. Multilevel and Longitudinal Modeling Using Stata, Volume I, Third Edition. 2012, page 279).|||<0.05
71730641|NCT01643876|142976187|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.5|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.||||<0.0001
71730642|NCT01643876|142976188|SUPERIORITY_OR_OTHER||Median Difference (Net)|-57.5|||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.||||<0.05
71658706|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.1|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 1: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.10|0.85|
71658707|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 3: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.11|0.91|
71658708|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.68|0.92|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 4: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.92|0.68|
71658709|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.73|0.94|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 5: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||0.94|0.73|
71730643|NCT02068118|142976191|SUPERIORITY||rate ratio|0.97|||=|0.8|TWO_SIDED|95.0|0.77|1.23|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.23|0.77|=0.80
71730644|NCT02068118|142976192|SUPERIORITY||rate ratio|0.82|||=|0.18|TWO_SIDED|95.0|0.62|1.1|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||1.10|0.62|=0.18
71730645|NCT02068118|142976193|SUPERIORITY||rate ratio|0.6|||=|0.02|TWO_SIDED|95.0|0.39|0.92|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths that occurred during hospitalization with an overnight stay were counted as two events."||0.92|0.39|=0.02
71771897|NCT02129777|143043863|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.36||0.389|TWO_SIDED|95.0|-3.9|1.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.5|-3.9|0.389
71771898|NCT02129777|143043863|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.39||0.316|TWO_SIDED|95.0|-4.2|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-4.2|0.316
71771899|NCT02129777|143043863|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.41||0.142|TWO_SIDED|95.0|-4.9|0.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.7|-4.9|0.142
71771900|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.73||0.229|TWO_SIDED|95.0|-5.6|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||1.4|-5.6|0.229
71831312|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.56|-0.19|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.19|-0.56|<0.0001
71730646|NCT02068118|142976194|SUPERIORITY||||||=|0.68|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.68
71730647|NCT02068118|142976196|SUPERIORITY||||||=|0.85|||||||Log Rank|||Time to death from any cause compared using the log-rank test||||=0.85
71730648|NCT02068118|142976197|SUPERIORITY||rate ratio|0.97|||=|0.77|TWO_SIDED|95.0|0.78|1.21|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).||1.21|0.78|=0.77
71730649|NCT02068118|142976198|SUPERIORITY||rate ratio|0.97|||=|0.83|TWO_SIDED|95.0|0.74|1.27|||negative binomial regression|||"Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up).~Deaths from cardiovascular cause that occurred during a hospitalization for cardiovascular cause with an overnight stay were counted as two events."||1.27|0.74|=0.83
71730650|NCT02068118|142976199|SUPERIORITY||rate ratio|0.84|||=|0.28|TWO_SIDED|95.0|0.62|1.15|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.15|0.62|=0.28
71730651|NCT02068118|142976200|SUPERIORITY||rate ratio|0.71|||=|0.078|TWO_SIDED|95.0|0.48|1.04|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||1.04|0.48|=0.078
71771901|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.65||0.863|TWO_SIDED|95.0|-3.6|3.0|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||3.0|-3.6|0.863
71658710|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.4|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.40|1.03|
71831313|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.29|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.29|-0.67|<0.0001
71831314|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0031|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.10|-0.49|0.0031
71831315|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.43|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.43|-0.82|<0.0001
71831316|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0425|TWO_SIDED|95.0|-0.43|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.01|-0.43|0.0425
71831317|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.65|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.23|-0.65|<0.0001
71831318|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.298|TWO_SIDED|95.0|-0.4|0.12|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.40|0.2980
71730652|NCT02068118|142976201|SUPERIORITY||rate ratio|0.5|||=|0.023|TWO_SIDED|95.0|0.28|0.91|||negative binomial regression|||Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up)||0.91|0.28|=0.023
71831319|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0179|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.58|0.0179
71831320|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.13||0.2328|TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.42|0.2328
71888899|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|11.69||||0.71|TWO_SIDED|95.0|-70.76|94.15||This is the test of effect modification by CD4 Stage at study entry.|t-test, 2 sided||A positive value would reflect greater treatment response for those with CD4 Stage 3 compared to those with less than Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.15|-70.76|0.71
71831321|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.1019|TWO_SIDED|95.0|-0.49|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.04|-0.49|0.1019
71730653|NCT02068118|142976202|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.044|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.99|0.62|=0.044
71730654|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|1.06|||=|0.17|TWO_SIDED|95.0|-2.48|4.61||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with physical functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.61|-2.48|=0.17
71730655|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|1.8|||=|0.23|TWO_SIDED|95.0|-2.61|6.21||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Physical score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role physical score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||6.21|-2.61|=0.23
71730656|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|4.46|||=|0.5|TWO_SIDED|95.0|0.59|8.33||Study group effect over time|Mixed Models Analysis|||ANCOVA Bodily Pain score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with bodily pain score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||8.33|0.59|=0.50
71730657|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|2.52|||=|0.19|TWO_SIDED|95.0|-0.07|5.12||Study group effect over time|Mixed Models Analysis|||ANCOVA General Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with general health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||5.12|-0.07|=0.19
71730658|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|2.38|||=|0.034|TWO_SIDED|95.0|-0.09|4.85||Study group effect over time|Mixed Models Analysis|||ANCOVA Vitality score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with vitality score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.85|-0.09|=0.034
71831322|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4002|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4002
71730659|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|4.03|||=|0.025|TWO_SIDED|95.0|0.6|7.47||Study group effect over time|Mixed Models Analysis|||ANCOVA Social Functioning score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with social functioning score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||7.47|0.60|=0.025
71730660|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|1.01|||=|0.9|TWO_SIDED|95.0|-2.79|4.81||Study group effect over time|Mixed Models Analysis|||ANCOVA Role Emotional score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with role emotional score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.81|-2.79|=0.90
71730661|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|2.26|||=|0.19|TWO_SIDED|95.0|0.16|4.37||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Health score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with mental health score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||4.37|0.16|=0.19
71730662|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|0.9|||=|0.26|TWO_SIDED|95.0|-0.48|2.28||Study group effect over time|Mixed Models Analysis|||ANCOVA Physical Component Summary (PCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with PCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.28|-0.48|=0.26
71739103|NCT00719355|142990990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|STANDARD_DEVIATION|14.4||0.033|TWO_SIDED|95.0||||A priori level of significance was set at p \<0.05.|ANCOVA|Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.||Observed power for our primary analysis was 0.64.||||0.033
71739104|NCT00719355|142990991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.65||0.109||95.0|||||ANCOVA|Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.||||||0.109
71739105|NCT02932748|142991028|SUPERIORITY||||||<|0.0001||||||A global one-way ANOVA was followed by two pairwise t-tests on the comparisons of interest, i.e., IP vs. EUC, and GP vs IP for weight change across 6 months, evaluated at p ≤ 0.025, using both intent-to-treat and completer only data.|ANOVA|||||||<.0001
71739106|NCT00066963|142991036|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|1.9|7.6|||Mantel Haenszel|2 d.f.|Counseling Only vs FV 2x/yr+Counseling|Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)||7.6|1.9|<0.001
71739107|NCT00988091|142991037|SUPERIORITY_OR_OTHER||Adjusted mean difference|5.33||||0.034|TWO_SIDED|95.0|0.41|10.24||The p-value was not adjusted for multiple comparisons because there was a single treatment comparison for the primary endpoint. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||A treatment difference of \>=7.0 mm and a pooled SD of 27.6 mm, requires a sample size of 244 subjects/treatment to complete the trial at 80% power at a two-sided significance level of 5%. To account for 18% dropout rate, the sample size was increased to 298/arm (total of 596). The primary null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||10.24|0.41|0.034
71658711|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.02|1.35|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6B: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.35|1.02|
71730663|NCT02068118|142976203|SUPERIORITY||Adjusted Means Difference|1.2|||=|0.17|TWO_SIDED|95.0|0.08|2.31||Study group effect over time|Mixed Models Analysis|||ANCOVA Mental Component Summary (MCS) score: Parametric analysis of covariance mixed model on repeated measurements (Baseline, 12 and 18 months) with MCS score assessed at baseline as covariate, study group and visit as fixed factors, interaction between study group and visit, interaction between study group and score assessed at baseline and patient as random factor||2.31|0.08|=0.17
71730664|NCT02068118|142976208|SUPERIORITY||||||=|0.03|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.03
71730665|NCT02068118|142976209|SUPERIORITY||||||=|0.15|||||||Log Rank|||Time to first event compared using the log-rank test||||=0.15
71730666|NCT02068118|142976210|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.02|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.95|0.53|=0.02
71730667|NCT02068118|142976211|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.043|TWO_SIDED|95.0|0.39|0.98|||Regression, Cox|||Time to first unplanned hospital readmission for heart failure compared using multivariable Cox regression model||0.98|0.39|=0.043
71730668|NCT01515475|142976217|OTHER||Risk Difference (RD)|3.0||||0.72|TWO_SIDED|95.0|-12.0|18.0|||Barnard's Exact Test|||||18|-12|0.72
71730669|NCT01515475|142976217|OTHER||Risk Difference (RD)|-13.0||||0.14|TWO_SIDED|95.0|-31.0|4.0|||Barnard's Exact Test|||||4|-31|0.14
71730670|NCT01515475|142976225|OTHER||Mean Difference (Final Values)|0.6||||0.002|TWO_SIDED|99.0|0.11|1.09||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.09|0.11|0.002
71730671|NCT01515475|142976225|OTHER||Mean Difference (Final Values)|0.58||||0.002|TWO_SIDED|99.0|0.1|1.06||Results are considered statistically significant if p\<0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||1.06|0.10|0.002
71730672|NCT01515475|142976225|OTHER||Mean Difference (Final Values)|0.16||||0.53|TWO_SIDED|99.0|-0.51|0.84||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.84|-0.51|0.53
71730673|NCT01515475|142976225|OTHER||Mean Difference (Final Values)|0.22||||0.38|TWO_SIDED|99.0|-0.43|0.86||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."||0.86|-0.43|0.38
71730674|NCT01515475|142976226|OTHER||Mean Difference (Final Values)|-25.0||||0.013|TWO_SIDED|99.0|-49.0|1.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the more hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||1|-49|0.013
71730675|NCT01515475|142976226|OTHER||Hazard Ratio, log|-18.0||||0.08|TWO_SIDED|99.0|-42.0|8.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||"Analysis for the less hyperopic eye:~Barnard's exact test was used to compare proportions between treatment groups."||8|-42|0.08
71730676|NCT01515475|142976227|OTHER||Mean Difference (Final Values)|0.01||||0.22|TWO_SIDED|99.0|-0.02|0.04|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.04|-0.02|0.22
71730677|NCT01515475|142976227|OTHER||Mean Difference (Final Values)|-0.02||||0.41|TWO_SIDED|99.0|-0.06|0.03|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.03|-0.06|0.41
71730678|NCT01515475|142976227|OTHER||Mean Difference (Final Values)|-0.05||||0.02|TWO_SIDED|99.0|-0.12|0.01|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.01|-0.12|0.02
71730679|NCT01515475|142976227|OTHER||Mean Difference (Final Values)|-0.07||||0.15|TWO_SIDED|99.0|-0.19|0.05|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p\<0.01."||0.05|-0.19|0.15
71730680|NCT01515475|142976228|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
71730681|NCT01515475|142976228|OTHER||Mean Difference (Final Values)|-2.0||||0.79|TWO_SIDED|99.0|-18.0|14.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||14|-18|0.79
71730682|NCT01515475|142976229|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||13|-18|0.51
71730683|NCT01515475|142976229|OTHER||Mean Difference (Final Values)|-4.0||||0.68|TWO_SIDED|99.0|-24.0|16.0||Results are considered statistically significant if p≤0.01.|Barnard's Exact Test|||Barnard's exact test was used to compare proportions between treatment groups.||16|-24|0.68
71658712|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.65|1.01|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 7F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.01|0.65|
71658713|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 9V: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
71658714|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.05|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 14: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.05|0.79|
71658715|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.97|1.23|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 18C: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.23|0.97|
71658716|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.07|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19A: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.07|0.89|
71730684|NCT01515475|142976230|OTHER||Mean Difference (Final Values)|-0.04||||0.21|TWO_SIDED|99.0|-0.12|0.05||Results are considered statistically significant if p\<0.01|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.05|-0.12|0.21
71730685|NCT01515475|142976230|OTHER||Mean Difference (Final Values)|-0.03||||0.25|TWO_SIDED|99.0|-0.1|0.04||Results are considered statistically significant if p≤0.01.|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.||0.04|-0.10|0.25
71771902|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.403|TWO_SIDED|95.0|-1.9|4.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.7|-1.9|0.403
71658717|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.83|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.83|
71771903|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.74||0.597|TWO_SIDED|95.0|-2.5|4.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.4|-2.5|0.597
71661187|NCT00945100|142835953|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.04
71730686|NCT01515475|142976231|OTHER||Mean Difference (Final Values)|-2.0||||0.51|TWO_SIDED|99.0|-18.0|13.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||13|-18|0.51
71730687|NCT01515475|142976231|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|99.0|-17.0|17.0||No p-value, because there was 0% difference||||Barnard's exact test used to compare proportions between treatment groups.||17|-17|
71730688|NCT01515475|142976232|OTHER||Mean Difference (Final Values)|0.02||||0.74|TWO_SIDED|99.0|-0.11|0.14||Results are considered statistically significant if p\<0.01.|ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.||0.14|-0.11|0.74
71730689|NCT01515475|142976232|OTHER||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|99.0|-0.4|0.1|||ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.||0.1|-0.4|0.15
71658718|NCT00546572|142832798|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was \> 0.5 (2-fold criterion).|geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.14|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 23F: geometric mean fold rise (GMFR) \[(13vPnC / 13vPnC) / (13vPnC)\] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.||2.14|1.60|
71730690|NCT01515475|142976233|OTHER||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|99.0|-14.0|26.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups||26|-14|0.53
71730691|NCT01515475|142976233|OTHER||Mean Difference (Final Values)|-19.0||||0.02|TWO_SIDED|99.0|-40.0|2.0||Results are considered statistically significant if p\<0.01.|Barnard's Exact Test|||Barnard's exact test used to compare proportions between treatment groups.||2|-40|0.02
71730692|NCT00130923|142976247|SUPERIORITY||difference in treatment slopes|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.054|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment slopes in a mixed model and its standard error.|||||0.054
71730693|NCT00130923|142976248|SUPERIORITY||Difference in treatment means|-0.62|STANDARD_ERROR_OF_MEAN|0.29||0.035|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.035
71730694|NCT00130923|142976249|SUPERIORITY||difference in treatment means|0.056|STANDARD_ERROR_OF_MEAN|0.099||0.57|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.57
71730695|NCT00130923|142976250|SUPERIORITY||difference in treatment means|2.65|STANDARD_ERROR_OF_MEAN|2.68||0.32|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient difference in treatment means in a mixed model and its standard error.|||||.32
71831323|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2149|TWO_SIDED|95.0|-0.45|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.10|-0.45|0.2149
71730696|NCT00130923|142976251|SUPERIORITY||difference in treatment means|0.93|STANDARD_ERROR_OF_MEAN|1.19||0.44|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.44
71730697|NCT00130923|142976252|SUPERIORITY|||||||0.003|||||||Chi-squared|Statistical test of hypothesis. Value of the Chi-squared statistic is 9.08||||||.003
71730698|NCT02256267|142976256|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0771|||||TWO_SIDED|90.0|0.0671|0.0886||||||||0.0886|0.0671|
71730699|NCT02256267|142976257|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.0467|||||TWO_SIDED|90.0|0.0376|0.0581||||||||0.0581|0.0376|
71730700|NCT04557787|142976258|SUPERIORITY||Mean Difference (Final Values)|28.4||||0.001|TWO_SIDED|95.0|12.2|44.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.6|12.2|0.001
71730701|NCT04557787|142976258|SUPERIORITY||Mean Difference (Final Values)|28.2||||0.001|TWO_SIDED|95.0|12.0|44.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||44.4|12.0|0.001
71730702|NCT04557787|142976258|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.983|TWO_SIDED|95.0|-16.0|16.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||16.3|-16.0|0.983
71730703|NCT04557787|142976259|SUPERIORITY||Mean Difference (Final Values)|33.2|||<|0.001|TWO_SIDED|95.0|17.0|49.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.4|17.0|<0.001
71730704|NCT04557787|142976259|SUPERIORITY||Mean Difference (Final Values)|29.7|||<|0.001|TWO_SIDED|95.0|13.5|46.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||46.0|13.5|<0.001
71730705|NCT04557787|142976259|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.667|TWO_SIDED|95.0|-12.6|19.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.7|-12.6|0.667
71730706|NCT04557787|142976260|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.503|TWO_SIDED|95.0|-14.2|7.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||7.0|-14.2|0.503
71730707|NCT04557787|142976260|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.916|TWO_SIDED|95.0|-10.1|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-10.1|0.916
71730708|NCT04557787|142976260|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.438|TWO_SIDED|95.0|-14.8|6.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied||6.5|-14.8|0.438
71730709|NCT04557787|142976261|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.955|TWO_SIDED|95.0|-10.3|10.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||10.9|-10.3|0.955
71730710|NCT04557787|142976261|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.118|TWO_SIDED|95.0|-19.2|2.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||2.2|-19.2|0.118
71730711|NCT04557787|142976261|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.104|TWO_SIDED|95.0|-1.8|19.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||19.5|-1.8|0.104
71730712|NCT04557787|142976262|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.352|TWO_SIDED|95.0|-0.22|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.22|0.352
71730713|NCT04557787|142976262|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.41|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.41|0.980
71730714|NCT04557787|142976262|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.21|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-0.21|0.339
71730715|NCT04557787|142976263|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.62|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.62|0.700
71831324|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2442|TWO_SIDED|95.0|-0.43|0.11|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.43|0.2442
71730716|NCT04557787|142976263|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.227|TWO_SIDED|95.0|-0.2|0.84||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.84|-0.20|0.227
71730717|NCT04557787|142976263|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.112|TWO_SIDED|95.0|-0.94|0.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.10|-0.94|0.112
71730718|NCT04557787|142976264|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.013|TWO_SIDED|95.0|0.22|1.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.17|0.22|0.013
71730719|NCT04557787|142976264|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.065|TWO_SIDED|95.0|-0.05|1.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.51|-0.05|0.065
71730720|NCT04557787|142976264|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.497|TWO_SIDED|95.0|-0.51|1.04||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.04|-0.51|0.497
71730721|NCT04557787|142976265|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.027|TWO_SIDED|95.0|0.06|0.88||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.88|0.06|0.027
71730722|NCT04557787|142976265|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.005|TWO_SIDED|95.0|0.19|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|0.19|0.005
71771904|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|2.32||0.416|TWO_SIDED|95.0|-2.7|6.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||6.5|-2.7|0.416
71771905|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.24||0.77|TWO_SIDED|95.0|-3.8|5.1|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.1|-3.8|0.770
71771906|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.31||0.798|TWO_SIDED|95.0|-4.0|5.2|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.2|-4.0|0.798
71771907|NCT02129777|143043864|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.767|TWO_SIDED|95.0|-4.1|5.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.5|-4.1|0.767
71771908|NCT02129777|143043865|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.043||0.57|TWO_SIDED|95.0|-0.11|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.11|0.570
71831325|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4609|TWO_SIDED|95.0|-0.37|0.17|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.37|0.4609
71831326|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8129|TWO_SIDED|95.0|-0.31|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.31|0.8129
71831327|NCT02528188|143167436|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7883|TWO_SIDED|95.0|-0.32|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.32|0.7883
71831328|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.0119|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.37|0.0119
71831329|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3073|TWO_SIDED|95.0|-0.24|0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.08|-0.24|0.3073
71771909|NCT02129777|143043865|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.619|TWO_SIDED|95.0|-0.1|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.06|-0.10|0.619
71771910|NCT02129777|143043865|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.597|TWO_SIDED|95.0|-0.06|0.11|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.11|-0.06|0.597
71771911|NCT02129777|143043865|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.509|TWO_SIDED|95.0|-0.06|0.12|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||0.12|-0.06|0.509
71771912|NCT02129777|143043866|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|5.32||0.845|TWO_SIDED|95.0|-11.7|9.6|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||9.6|-11.7|0.845
71771913|NCT02129777|143043866|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|4.8||0.323|TWO_SIDED|95.0|-4.8|14.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||14.4|-4.8|0.323
71831330|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|95.0|-0.5|-0.15|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.15|-0.50|0.0002
71730723|NCT04557787|142976265|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.532|TWO_SIDED|95.0|-0.54|0.28||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.28|-0.54|0.532
71730724|NCT04557787|142976266|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.26|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-0.26|0.461
71730725|NCT04557787|142976266|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.12|TWO_SIDED|95.0|-0.09|0.73||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.73|-0.09|0.120
71730726|NCT04557787|142976266|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.404|TWO_SIDED|95.0|-0.58|0.24||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.24|-0.58|0.404
71730727|NCT04557787|142976267|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.478|TWO_SIDED|95.0|-0.33|0.71||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.71|-0.33|0.478
71771914|NCT02129777|143043866|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|4.89||0.697|TWO_SIDED|95.0|-11.7|7.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.8|-11.7|0.697
71730728|NCT04557787|142976267|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.824|TWO_SIDED|95.0|-0.46|0.58||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.58|-0.46|0.824
71730729|NCT04557787|142976267|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.626|TWO_SIDED|95.0|-0.39|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-0.39|0.626
71730730|NCT04557787|142976268|SUPERIORITY||Mean Difference (Final Values)|0.86||||0.03|TWO_SIDED|95.0|0.09|1.64||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.64|0.09|0.030
71730731|NCT04557787|142976268|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.027|TWO_SIDED|95.0|0.11|1.66||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.66|0.11|0.027
71730732|NCT04557787|142976268|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.956|TWO_SIDED|95.0|-0.8|0.75||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.75|-0.80|0.956
71730733|NCT04557787|142976269|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.084|TWO_SIDED|95.0|-0.05|0.78||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.78|-0.05|0.084
71730734|NCT04557787|142976269|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.063|TWO_SIDED|95.0|-0.02|0.81||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.81|-0.02|0.063
71730735|NCT04557787|142976269|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.885|TWO_SIDED|95.0|-0.44|0.38||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.38|-0.44|0.885
71730736|NCT01969500|142976279|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|3.81||0.85|TWO_SIDED|95.0|-8.37|6.96|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||6.96|-8.37|.85
71730737|NCT01969500|142976280|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.67||0.44|TWO_SIDED|95.0|-4.66|2.06|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks|||2.06|-4.66|.44
71730738|NCT00613080|142976283|SUPERIORITY_OR_OTHER||Proportion (reported as percentage)|51.0||||0.93|TWO_SIDED||||||Chi-squared|||This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.||||0.93
71730739|NCT02726880|142976307|SUPERIORITY||F|1.13||||0.296|TWO_SIDED||||||ANCOVA|Number of days of gaming in the past week, measured at baseline, is included as a covariate in the model.||||||.296
71730740|NCT03553498|142976317|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71730741|NCT03553498|142976318|SUPERIORITY|||||||0.989|||||||Chi-squared|||||||0.989
71730742|NCT03553498|142976319|SUPERIORITY|||||||0.414|||||||Chi-squared|||||||0.414
71730743|NCT03553498|142976320|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
71730744|NCT02741570|142976323|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0469|TWO_SIDED|97.51|0.59|1.03|||Log Rank|stratified regular log-rank test||||1.03|0.59|0.0469
71730745|NCT02741570|142976324|SUPERIORITY||Cox Proportional Hazard|0.95||||0.4951|TWO_SIDED|97.9|0.8|1.13|||Log Rank|stratified regular log-rank test||||1.13|0.80|0.4951
71730746|NCT02741570|142976325|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.68|0.95||||||||0.95|0.68|
71730747|NCT02741570|142976326|SUPERIORITY||Cox Proportional Hazard|1.4|||||TWO_SIDED|95.0|1.19|1.63|||||All Randomized Participants|||1.63|1.19|
71730748|NCT02741570|142976326|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.77|1.3|||||All Randomized PD-L1 CPS \>= 20 Participants|||1.30|0.77|
71730749|NCT02741570|142976329|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||||0.97|0.60|
71730750|NCT02741570|142976330|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.82|1.08||||||||1.08|0.82|
71730751|NCT02700165|142976344|OTHER||sucess proportion|78.6|||||TWO_SIDED|95.0|49.2|95.3|||||Independent physician reviewers correctly identified 13/14, 11/14 and 10/14, respectively for an overall percentage of correct identification of 34/42 or 81%. Two of three reviewers correctly identified 11/14 (78.6%) photos.|||95.3|49.2|
71730752|NCT02011490|142976348|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.42|||||TWO_SIDED|90.0|4.12|7.11|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an analysis of variance (ANOVA) linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.11|4.12|
71730753|NCT02011490|142976348|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.17|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.17|1.84|
71730754|NCT02011490|142976349|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|5.49|||||TWO_SIDED|90.0|4.18|7.22|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||7.22|4.18|
71730755|NCT02011490|142976349|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|2.42|||||TWO_SIDED|90.0|1.84|3.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||3.18|1.84|
71730756|NCT02011490|142976350|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|90.0|0.73|1.21|||||Difference in least squares means of log-transformed data (severe renal impaired - healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.21|0.73|
71730757|NCT02011490|142976350|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.92|||||TWO_SIDED|90.0|0.72|1.18|||||Difference in least squares means of log-transformed data (moderate renal impaired - healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect||1.18|0.72|
71730758|NCT03697993|142976368|OTHER||Risk Difference (RD)|-18.0||||0.264|TWO_SIDED|95.0|-43.4|8.7|||Multiple imputation using Wald method|||||8.7|-43.4|0.264
71730759|NCT03697993|142976372|OTHER||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-26.2|24.3|||Fisher Exact|||||24.3|-26.2|1.000
71730760|NCT03697993|142976373|OTHER||Odds Ratio (OR)|0.9||||0.894|TWO_SIDED|95.0|0.3|2.5|||Proportional odds model using Wald test|||||2.5|0.3|0.894
71730761|NCT03697993|142976374|OTHER||Risk Difference (RD)|0.0||||0.973|TWO_SIDED|95.0|-26.3|25.3|||Multiple imputation using Wald method|||||25.3|-26.3|0.973
71730762|NCT04384107|142976377|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.1|||=|0.641|TWO_SIDED|95.0|-5.9|3.6|||Miettinen & Nurminen|||Injection site erythema||3.6|-5.9|= 0.641
71730763|NCT04384107|142976377|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2|||=|0.937|TWO_SIDED|95.0|-6.1|5.6|||Miettinen & Nurminen|||Injection site induration||5.6|-6.1|= 0.937
71730764|NCT04384107|142976377|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|7.1|||=|0.036|TWO_SIDED|95.0|0.5|13.8|||Miettinen & Nurminen|||Injection site pain||13.8|0.5|= 0.036
71730765|NCT04384107|142976377|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-4.0|||=|0.208|TWO_SIDED|95.0|-10.2|2.2|||Miettinen & Nurminen|||Injection site swelling||2.2|-10.2|= 0.208
71730766|NCT04384107|142976378|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.4|||=|0.912|TWO_SIDED|95.0|-6.7|6.0|||Miettinen & Nurminen|||Decreased appetite||6.0|-6.7|= 0.912
71730767|NCT04384107|142976378|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|5.9|||=|0.108|TWO_SIDED|95.0|-1.3|13.0|||Miettinen & Nurminen|||Irritability||13.0|-1.3|= 0.108
71730768|NCT04384107|142976378|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.0|||=|0.792|TWO_SIDED|95.0|-6.4|8.4|||Miettinen & Nurminen|||Somnolence||8.4|-6.4|= 0.792
71730769|NCT04384107|142976378|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.3|||=|0.843|TWO_SIDED|95.0|-3.5|2.8|||Miettinen & Nurminen|||Urticaria||2.8|-3.5|= 0.843
71730770|NCT04384107|142976379|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
71730771|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71730772|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.3|||<|0.001|TWO_SIDED|95.0|1.0|4.5|||Miettinen and Nurminen|||Serotype 3: Participants With IgG ≥0.35 μg/mL||4.5|1.0|< 0.001
71730773|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 4: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
71730774|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 5: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
71730775|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.2|||Miettinen and Nurminen|||Serotype 6A: Participants With IgG ≥0.35 μg/mL||0.2|-2.6|< 0.001
71730776|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-3.9|||<|0.001|TWO_SIDED|95.0|-6.9|-1.3|||Miettinen and Nurminen|||Serotype 6B: Participants With IgG ≥0.35 μg/mL||-1.3|-6.9|< 0.001
71730777|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 7F: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71730778|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 9V: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71730779|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.9|1.1|||Miettinen and Nurminen|||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.9|< 0.001
71771915|NCT02129777|143043866|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|5.1||0.633|TWO_SIDED|95.0|-12.6|7.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.7|-12.6|0.633
71771916|NCT02129777|143043867|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.64||0.537|TWO_SIDED|95.0|-2.2|4.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||4.3|-2.2|0.537
71771917|NCT02129777|143043867|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|1.62||0.142|TWO_SIDED|95.0|-0.8|5.6|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.6|-0.8|0.142
71771918|NCT02129777|143043867|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.63||0.015|TWO_SIDED|95.0|0.8|7.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||7.3|0.8|0.015
71771919|NCT02129777|143043867|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.64||0.121|TWO_SIDED|95.0|-0.7|5.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.||5.8|-0.7|0.121
71771920|NCT01754909|143043889|SUPERIORITY|Occurrence rates, comparison by t test||||||0.05|||||||t-test, 2 sided|||||||0.05
71771921|NCT03101267|143043934|SUPERIORITY||Adjusted mean difference|0.09||||0.777|TWO_SIDED|95.0|-0.52|0.69|||Mixed model for repeated measures (MMRM)|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.69|-0.52|0.777
71771922|NCT03101267|143043934|SUPERIORITY||Adjusted mean difference|-0.01||||0.983||95.0|-0.61|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||3TNSS treatment comparison||0.59|-0.61|0.983
71771923|NCT03101267|143043935|SUPERIORITY||Adjusted mean difference|0.17||||0.71|TWO_SIDED|95.0|-0.75|1.1|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||1.10|-0.75|0.710
71771924|NCT03101267|143043935|SUPERIORITY||Adjusted mean difference|0.07||||0.872|TWO_SIDED|95.0|-0.84|0.99|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 127||0.99|-0.84|0.872
71771925|NCT03101267|143043935|SUPERIORITY||Adjusted mean difference|0.18||||0.701|TWO_SIDED|95.0|-0.73|1.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||1.08|-0.73|0.701
71771926|NCT03101267|143043935|SUPERIORITY||Adjusted mean difference|-0.04||||0.925||95.0|-0.95|0.86|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 155||0.86|-0.95|0.925
71771927|NCT03101267|143043935|SUPERIORITY||Adjusted mean difference|0.16||||0.69|TWO_SIDED|95.0|-0.64|0.97|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.97|-0.64|0.690
71771928|NCT03101267|143043935|SUPERIORITY||Adjusted mean difference|0.07||||0.868|TWO_SIDED|95.0|-0.73|0.87|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||4TNSS treatment comparison at day 183||0.87|-0.73|0.868
71771929|NCT03101267|143043936|SUPERIORITY||Adjusted mean difference|0.07||||0.502|TWO_SIDED|95.0|-0.14|0.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.29|-0.14|0.502
71771930|NCT03101267|143043936|SUPERIORITY||Adjusted mean difference|-0.02||||0.879|TWO_SIDED|95.0|-0.23|0.2|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 127||0.20|-0.23|0.879
71771931|NCT03101267|143043936|SUPERIORITY||Adjusted mean difference|0.06||||0.444|TWO_SIDED|95.0|-0.1|0.22|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.22|-0.10|0.444
71771932|NCT03101267|143043936|SUPERIORITY||Adjusted mean difference|0.0||||0.987|TWO_SIDED|95.0|-0.16|0.16|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 155||0.16|-0.16|0.987
71730780|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.2|||<|0.001|TWO_SIDED|95.0|-3.0|-0.1|||Miettinen and Nurminen|||Serotype 18C: Participants With IgG ≥0.35 μg/mL||-0.1|-3.0|< 0.001
71730781|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-0.3|||<|0.001|TWO_SIDED|95.0|-1.7|0.8|||Miettinen and Nurminen|||Serotype 19A: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|< 0.001
71730782|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|0.0|||<|0.001|TWO_SIDED|95.0|-1.1|1.1|||Miettinen and Nurminen|||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|< 0.001
71730783|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-1.8|||<|0.001|TWO_SIDED|95.0|-4.0|-0.2|||Miettinen and Nurminen|||Serotype 23F: Participants With IgG ≥0.35 μg/mL||-0.2|-4.0|< 0.001
71730784|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|2.0|||<|0.001|TWO_SIDED|95.0|0.4|4.3|||Miettinen and Nurminen|||Serotype 22F: Participants With IgG ≥0.35 μg/mL||4.3|0.4|<0.001
71730785|NCT04384107|142976380|NON_INFERIORITY|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI and p-value based on the method of Miettinen and Nurminen stratified by age category. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - PCV13) being \>-10 percentage points (1-sided p-value \<0.025).|Difference in Percent|-6.8|||=|0.048|TWO_SIDED|95.0|-10.6|-3.5|||Miettinen and Nurminen|||Serotype 33F: Participants With IgG ≥0.35 μg/mL||-3.5|-10.6|= 0.048
71730786|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.55|0.67|||Linear model|||Serotype 1: IgG GMC Ratio||0.67|0.55|< 0.001
71730787|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.85|||<|0.001|TWO_SIDED|95.0|1.67|2.05|||Linear model|||Serotype 3: IgG GMC Ratio||2.05|1.67|< 0.001
71730788|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93|||Linear model|||Serotype 4: IgG GMC Ratio||0.93|0.76|< 0.001
71730789|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.87|||Linear model|||Serotype 5: IgG GMC Ratio||0.87|0.69|< 0.001
71730790|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.56|||=|0.019|TWO_SIDED|95.0|0.5|0.63|||Linear model|||Serotype 6A: IgG GMC Ratio||0.63|0.50|= 0.019
71730791|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.59|||=|0.015|TWO_SIDED|95.0|0.51|0.68|||Linear model|||Serotype 6B: IgG GMC Ratio||0.68|0.51|= 0.015
71730792|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.75|0.94|||Linear model|||Serotype 7F: IgG GMC Ratio||0.94|0.75|< 0.001
71730793|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.97|||Linear model|||Serotype 9V: IgG GMC Ratio||0.97|0.78|< 0.001
71730794|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.66|0.85|||Linear model|||Serotype 14: IgG GMC Ratio||0.85|0.66|< 0.001
71730795|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.82|||Linear model|||Serotype 18C: IgG GMC Ratio||0.82|0.67|< 0.001
71730796|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.65|||<|0.001|TWO_SIDED|95.0|0.59|0.72|||Linear model|||Serotype 19A: IgG GMC Ratio||0.72|0.59|< 0.001
71730797|NCT04384107|142976381|NON_INFERIORITY|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors. A conclusion of non-inferiority of V114 to PCV13 is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/PCV13) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.69|0.82|||Linear model|||Serotype 19F: IgG GMC Ratio||0.82|0.69|< 0.001
71730798|NCT04384107|142976382|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|107.45|||||TWO_SIDED|95.0|96.18|120.03||||||Serotype 22F: IgG GMC Ratio||120.03|96.18|
71730799|NCT04384107|142976382|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|32.48|||||TWO_SIDED|95.0|27.72|38.05||||||Serotype 33F: IgG GMC Ratio||38.05|27.72|
71771933|NCT03101267|143043936|SUPERIORITY||Adjusted mean difference|0.03||||0.645|TWO_SIDED|95.0|-0.12|0.18|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.18|-0.12|0.645
71730800|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 1: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
71730801|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|3.3|||||TWO_SIDED|95.0|1.8|5.8||||||Serotype 3: Participants With IgG ≥0.35 μg/mL||5.8|1.8|
71730802|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|-0.3|||||TWO_SIDED|95.0|-1.7|0.8||||||Serotype 4: Participants With IgG ≥0.35 μg/mL||0.8|-1.7|
71730803|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 5: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730804|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730805|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 6B: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730806|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 7F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730807|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 9V: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730808|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 14: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730809|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 18C: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730810|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19A: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71730811|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Serotype 19F: Participants With IgG ≥0.35 μg/mL||1.1|-1.1|
71771934|NCT03101267|143043936|SUPERIORITY||Adjusted mean difference|-0.07||||0.357|TWO_SIDED|95.0|-0.22|0.08|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Sneezing score treatment comparison at day 183||0.08|-0.22|0.357
71771935|NCT03101267|143043937|SUPERIORITY||Adjusted mean difference|0.12||||0.472|TWO_SIDED|95.0|-0.2|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.44|-0.20|0.472
71658719|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.1|1.76|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.76|1.10|
71730812|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|0.3|||||TWO_SIDED|95.0|-1.1|1.9||||||Serotype 23F: Participants With IgG ≥0.35 μg/mL||1.9|-1.1|
71730813|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|94.8|||||TWO_SIDED|95.0|91.8|96.7||||||Serotype 22F: Participants With IgG ≥0.35 μg/mL||96.7|91.8|
71730814|NCT04384107|142976383|OTHER|The stratum-adjusted proportion difference using the Cochran-Mantel-Haenszel weight, and the corresponding 95% CI based on the method of Miettinen and Nurminen stratified by age category.|Difference in Percent|88.5|||||TWO_SIDED|95.0|84.5|91.6||||||Serotype 33F: Participants With IgG ≥0.35 μg/mL||91.6|84.5|
71730815|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.53|||||TWO_SIDED|95.0|0.47|0.59||||||Serotype 1: IgG GMC Ratio||0.59|0.47|
71730816|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.9||||||Serotype 3: IgG GMC Ratio||1.90|1.53|
71730817|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05||||||Serotype 4: IgG GMC Ratio||1.05|0.80|
71730818|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.75||||||Serotype 5: IgG GMC Ratio||0.75|0.59|
71730819|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.64|||||TWO_SIDED|95.0|0.56|0.73||||||Serotype 6A: IgG GMC Ratio||0.73|0.56|
71730820|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 6B: IgG GMC Ratio||0.84|0.65|
71730821|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.92||||||Serotype 7F: IgG GMC Ratio||0.92|0.71|
71730822|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94||||||Serotype 9V: IgG GMC Ratio||0.94|0.73|
71730823|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||Serotype 14: IgG GMC Ratio||0.96|0.74|
71730824|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||Serotype 18C: IgG GMC Ratio||1.14|0.87|
71730825|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92||||||Serotype 19A: IgG GMC Ratio||0.92|0.73|
71730826|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.75|0.94||||||Serotype 19F: IgG GMC Ratio||0.94|0.75|
71730827|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7||||||Serotype 23F: IgG GMC Ratio||0.70|0.52|
71730828|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|86.74|||||TWO_SIDED|95.0|77.61|96.95||||||Serotype 22F: IgG GMC Ratio||96.95|77.61|
71730829|NCT04384107|142976384|OTHER|Based on a linear model with natural log-transformed IgG concentrations as response variable, and vaccination group and age category as factors.|GMC Ratio|45.44|||||TWO_SIDED|95.0|40.07|51.54||||||Serotype 33F: IgG GMC Ratio||51.54|40.07|
71730830|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.55|0.78||||||Serotype 1: OPA GMT Ratio||0.78|0.55|
71730831|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.23|1.59||||||Serotype 3: OPA GMT Ratio||1.59|1.23|
71730832|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1||||||Serotype 4: OPA GMT Ratio||1.10|0.85|
71730833|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Serotype 5: OPA GMT Ratio||1.04|0.80|
71730834|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 6A: OPA GMT Ratio||0.89|0.65|
71730835|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.95||||||Serotype 6B: OPA GMT Ratio||0.95|0.69|
71730836|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.95||||||Serotype 7F: OPA GMT Ratio||0.95|0.70|
71730837|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 9V: OPA GMT Ratio||0.94|0.71|
71730838|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.97|1.38||||||Serotype 14: OPA GMT Ratio||1.38|0.97|
71730839|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11||||||Serotype 18C: OPA GMT Ratio||1.11|0.90|
71730840|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.61|0.77||||||Serotype 19A: OPA GMT Ratio||0.77|0.61|
71831331|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.22|-0.56|<0.0001
71658720|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.1|||||TWO_SIDED|95.0|0.91|1.34|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.34|0.91|
71730841|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.04||||||Serotype 19F: OPA GMT Ratio||1.04|0.84|
71730842|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.53|0.74||||||Serotype 23F: OPA GMT Ratio||0.74|0.53|
71730843|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|560.46|||||TWO_SIDED|95.0|474.05|662.63||||||Serotype 22F: OPA GMT Ratio||662.63|474.05|
71730844|NCT04384107|142976385|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|196.14|||||TWO_SIDED|95.0|141.85|271.21||||||Serotype 33F: OPA GMT Ratio||271.21|141.85|
71730845|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.75||||||Serotype 1: OPA GMT Ratio||0.75|0.38|
71730846|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.03||||||Serotype 3: OPA GMT Ratio||2.03|1.28|
71730847|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.93||||||Serotype 4: OPA GMT Ratio||0.93|0.57|
71730848|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.13||||||Serotype 5: OPA GMT Ratio||1.13|0.66|
71730849|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.91||||||Serotype 6A: OPA GMT Ratio||0.91|0.57|
71730850|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.66|||||TWO_SIDED|95.0|0.52|0.83||||||Serotype 6B: OPA GMT Ratio||0.83|0.52|
71730851|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 7F: OPA GMT Ratio||1.07|0.68|
71730852|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.65|||||TWO_SIDED|95.0|0.5|0.84||||||Serotype 9V: OPA GMT Ratio||0.84|0.50|
71730853|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.48|||||TWO_SIDED|95.0|1.16|1.9||||||Serotype 14: OPA GMT Ratio||1.90|1.16|
71730854|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.19|||||TWO_SIDED|95.0|0.95|1.48||||||Serotype 18C: OPA GMT Ratio||1.48|0.95|
71730855|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Serotype 19A: OPA GMT Ratio||1.01|0.60|
71730856|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|1.23|||||TWO_SIDED|95.0|1.0|1.52||||||Serotype 19F: OPA GMT Ratio||1.52|1.00|
71658721|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.3|||||TWO_SIDED|95.0|1.66|3.25|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||3.25|1.66|
71730857|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|0.37|||||TWO_SIDED|95.0|0.28|0.49||||||Serotype 23F: OPA GMT Ratio||0.49|0.28|
71730858|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|155.88|||||TWO_SIDED|95.0|101.84|238.59||||||Serotype 22F: OPA GMT Ratio||238.59|101.84|
71730859|NCT04384107|142976386|OTHER|Based on a linear model with natural log-transformed OPA titers as response variable, and vaccination group and age category as factors.|GMT Ratio|16.81|||||TWO_SIDED|95.0|11.74|24.08||||||Serotype 33F: OPA GMT Ratio||24.08|11.74|
71730860|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance between baseline and 24 month follow-up;||||0.025
71730861|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
71730862|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
71730863|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance from baseline to 24 month follow-up;||||0.025
71730864|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.747
71730865|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
71771936|NCT03101267|143043937|SUPERIORITY||Adjusted mean difference|-0.11||||0.497|TWO_SIDED|95.0|-0.43|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 127||0.21|-0.43|0.497
71771937|NCT03101267|143043937|SUPERIORITY||Adjusted mean difference|0.04||||0.821|TWO_SIDED|95.0|-0.28|0.36|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.36|-0.28|0.821
71658722|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.21|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.06|1.21|
71730866|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
71730867|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional-FDI comparison between G1G2 and G3G4 and G5G6 Arms success rate from baseline to 24 month recall. For Esthetic and Biological-FDI comparison p values were \> 0.05. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
71730868|NCT02698371|142976398|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms retention rate from baseline to 24 month recall. Adjusted P-values.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
71730869|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
71730870|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.189
71730871|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;||||0.189
71730872|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.025
71771938|NCT03101267|143043937|SUPERIORITY||Adjusted mean difference|-0.13||||0.414|TWO_SIDED|95.0|-0.45|0.19|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 155||0.19|-0.45|0.414
71730873|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.154|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;||||0.154
71730874|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;||||0.747
71730875|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;||||0.070
71730876|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;||||0.070
71730877|NCT02698371|142976399|EQUIVALENCE|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;||||0.070
71730878|NCT02698371|142976400|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Esthetic of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Esthetic outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
71771939|NCT03101267|143043937|SUPERIORITY||Adjusted mean difference|0.12||||0.414|TWO_SIDED|95.0|-0.17|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.41|-0.17|0.414
71771940|NCT03101267|143043937|SUPERIORITY||Adjusted mean difference|0.08||||0.566|TWO_SIDED|95.0|-0.2|0.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal discharge score treatment comparison at day 183||0.37|-0.20|0.566
71771941|NCT03101267|143043938|SUPERIORITY||Adjusted mean difference|-0.04||||0.822||95.0|-0.37|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.30|-0.37|0.822
71771942|NCT03101267|143043938|SUPERIORITY||Adjusted mean difference|0.09||||0.587|TWO_SIDED|95.0|-0.24|0.42|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 127||0.42|-0.24|0.587
71831332|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.0251|TWO_SIDED|95.0|-0.39|-0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.03|-0.39|0.0251
71831333|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.66|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.30|-0.66|<0.0001
71658723|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|3.8|||||TWO_SIDED|95.0|2.78|5.07|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||5.07|2.78|
71661188|NCT00945100|142835953|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.89
71730879|NCT02698371|142976400|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Functional outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||1.000
71730880|NCT02698371|142976400|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.998||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Biologic FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Biological outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.||||0.998
71730881|NCT02698371|142976401|EQUIVALENCE|alpha value of 0.05 was considered||||||0.029||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Luster Performance at 24 Month Follow-up recall.||||0.029
71771943|NCT03101267|143043938|SUPERIORITY||Adjusted mean difference|0.0||||0.975|TWO_SIDED|95.0|-0.3|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.30|0.975
71771944|NCT03101267|143043938|SUPERIORITY||Adjusted mean difference|0.0||||0.98|TWO_SIDED|95.0|-0.31|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 155||0.31|-0.31|0.980
71658724|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.8|1.67|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.67|0.80|
71658725|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.8|||||TWO_SIDED|95.0|1.18|2.62|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.62|1.18|
71658726|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.62|1.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.13|0.62|
71658727|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||TWO_SIDED|95.0|1.53|2.69|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.69|1.53|
71730882|NCT02698371|142976401|EQUIVALENCE|alpha value of 0.05 was considered||||||0.002||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall;||||0.002
71730883|NCT02698371|142976401|EQUIVALENCE|alpha value of 0.05 was considered||||||0.618||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall.||||0.618
71730884|NCT02698371|142976402|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.009||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.009
71730885|NCT02698371|142976402|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.059||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.||||0.059
71730886|NCT02698371|142976402|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.829||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Staining Margin performance at 24 month follow-up recall.||||0.829
71730887|NCT02698371|142976403|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) Colour Stability-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
71730888|NCT02698371|142976403|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||<0.001
71658728|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.37|2.1|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||2.10|1.37|
71658729|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|1.93|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||1.93|1.09|
71730889|NCT02698371|142976403|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.064||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.||||0.064
71730890|NCT02698371|142976404|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.006||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.006
71730891|NCT02698371|142976404|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.020
71730892|NCT02698371|142976404|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.054||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.||||0.054
71730893|NCT02698371|142976405|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.01||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.010
71730894|NCT02698371|142976405|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.071||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.071
71730895|NCT02698371|142976405|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.898||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.||||0.898
71730896|NCT02698371|142976406|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.317
71730897|NCT02698371|142976406|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.180
71730898|NCT02698371|142976406|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.||||0.918
71730899|NCT02698371|142976407|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.317
71771945|NCT03101267|143043938|SUPERIORITY||Adjusted mean difference|-0.07||||0.621|TWO_SIDED|95.0|-0.35|0.21|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.21|-0.35|0.621
71658730|NCT00546572|142832799|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was \> 0.5 (2-fold criterion).|ratio of geometric mean titer|7.3|||||TWO_SIDED|95.0|5.36|9.82|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.||9.82|5.36|
71661189|NCT00945100|142835953|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.49
71730900|NCT02698371|142976407|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||.317
71730901|NCT02698371|142976407|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.575||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion \& Abfraction-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.||||0.575
71730902|NCT02698371|142976408|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.020
71730903|NCT02698371|142976408|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.107||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.107
71730904|NCT02698371|142976408|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.592||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.||||0.592
71730905|NCT02698371|142976409|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
71730906|NCT02698371|142976409|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
71730907|NCT02698371|142976409|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.||||1.000
71730908|NCT02698371|142976410|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.011||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.011
71730909|NCT02698371|142976410|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.034||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.034
71730910|NCT02698371|142976410|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.885||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.||||0.885
71730911|NCT02698371|142976411|EQUIVALENCE|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||1.000
71771946|NCT03101267|143043938|SUPERIORITY||Adjusted mean difference|-0.03||||0.831|TWO_SIDED|95.0|-0.31|0.25|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Nasal congestion score treatment comparison at day 183||0.25|-0.31|0.831
71661190|NCT00945100|142835953|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANCOVA|||The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term.||||0.37
71730912|NCT02698371|142976411|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.317
71658731|NCT00546572|142832800|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|12.1|||||TWO_SIDED|95.0|8.92|16.44|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC / 13vPnC )- (23vPS)\].|"Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was \>2."||16.44|8.92|
71730913|NCT02698371|142976411|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.403||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Color Match performance at 24 month follow-up recall.||||0.403
71730914|NCT02698371|142976412|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
71730915|NCT02698371|142976412|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.020
71730916|NCT02698371|142976412|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.04||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Retention performance at 24 month follow-up recall.||||0.040
71730917|NCT02698371|142976413|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
71730918|NCT02698371|142976413|EQUIVALENCE|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||<0.001
71730919|NCT02698371|142976413|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.211||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.||||0.211
71730920|NCT02698371|142976414|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.102||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.102
71771947|NCT03101267|143043939|SUPERIORITY||Adjusted mean difference|0.03||||0.864|TWO_SIDED|95.0|-0.29|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.35|-0.29|0.864
71771948|NCT03101267|143043939|SUPERIORITY||Adjusted mean difference|0.11||||0.502|TWO_SIDED|95.0|-0.21|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 127||0.43|-0.21|0.502
71771949|NCT03101267|143043939|SUPERIORITY||Adjusted mean difference|0.07||||0.652|TWO_SIDED|95.0|-0.25|0.4|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.40|-0.25|0.652
71658732|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-11.4|||<|0.001|TWO_SIDED|95.0|-17.3|-5.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.6|-17.3|<0.001
71658733|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.129|TWO_SIDED|95.0|-9.1|1.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.1|-9.1|0.129
71658734|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-6.8||||0.002|TWO_SIDED|95.0|-11.3|-2.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.3|-11.3|0.002
71771950|NCT03101267|143043939|SUPERIORITY||Adjusted mean difference|0.08||||0.633|TWO_SIDED|95.0|-0.25|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 155||0.41|-0.25|0.633
71771951|NCT03101267|143043939|SUPERIORITY||Adjusted mean difference|0.07||||0.596|TWO_SIDED|95.0|-0.2|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.35|-0.20|0.596
71771952|NCT03101267|143043939|SUPERIORITY||Adjusted mean difference|0.07||||0.621|TWO_SIDED|95.0|-0.21|0.34|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy nose score treatment comparison at day 183||0.34|-0.21|0.621
71771953|NCT03101267|143043940|SUPERIORITY||Adjusted mean difference|0.21||||0.336|TWO_SIDED|95.0|-0.22|0.65|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.65|-0.22|0.336
71831334|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0625|TWO_SIDED|95.0|-0.39|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.01|-0.39|0.0625
71831335|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.54|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||-0.14|-0.54|0.0010
71831336|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4005|TWO_SIDED|95.0|-0.36|0.14|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.14|-0.36|0.4005
71831337|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.053|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.00|-0.50|0.0530
71831338|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4074|TWO_SIDED|95.0|-0.37|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.37|0.4074
71831339|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2629|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2629
71771954|NCT03101267|143043940|SUPERIORITY||Adjusted mean difference|0.36||||0.102|TWO_SIDED|95.0|-0.07|0.8|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 127||0.80|-0.07|0.102
71831340|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5582|TWO_SIDED|95.0|-0.34|0.18|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.18|-0.34|0.5582
71831341|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4907|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.35|0.4907
71771955|NCT03101267|143043940|SUPERIORITY||Adjusted mean difference|0.11||||0.625|TWO_SIDED|95.0|-0.34|0.56|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.56|-0.34|0.625
71771956|NCT03101267|143043940|SUPERIORITY||Adjusted mean difference|0.33||||0.145|TWO_SIDED|95.0|-0.12|0.78|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 155||0.78|-0.12|0.145
71771957|NCT03101267|143043940|SUPERIORITY||Adjusted mean difference|0.19||||0.364|TWO_SIDED|95.0|-0.22|0.59|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.59|-0.22|0.364
71771958|NCT03101267|143043940|SUPERIORITY||Adjusted mean difference|0.35||||0.082|TWO_SIDED|95.0|-0.05|0.76|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||TNNSS treatment comparison at day 183||0.76|-0.05|0.082
71771959|NCT03101267|143043941|SUPERIORITY||Adjusted mean difference|0.07||||0.623|TWO_SIDED|95.0|-0.21|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.35|-0.21|0.623
71771960|NCT03101267|143043941|SUPERIORITY||Adjusted mean difference|0.15||||0.288|TWO_SIDED|95.0|-0.13|0.43|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 127||0.43|-0.13|0.288
71658735|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-3.2||||0.028|TWO_SIDED|95.0|-6.3|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Redness: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-6.3|0.028
71730921|NCT02698371|142976414|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.18||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.180
71730922|NCT02698371|142976414|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.99||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.||||0.990
71730923|NCT02698371|142976415|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.157||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.157
71730924|NCT02698371|142976415|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.317
71730925|NCT02698371|142976415|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.334||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.||||0.334
71730926|NCT02698371|142976416|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.132||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.132
71730927|NCT02698371|142976416|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.257||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.257
71730928|NCT02698371|142976416|EQUIVALENCE|An alpha value of 0.05 was considered||||||0.918||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 - Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.||||0.918
71730929|NCT00098722|142976450|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1802|||TWO_SIDED|97.5|-1.426|-0.616||||||The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.616|-1.426|
71730930|NCT00098722|142976450|SUPERIORITY_OR_OTHER||LS mean difference|-1.042|STANDARD_ERROR_OF_MEAN|0.1786|||TWO_SIDED|97.5|-1.444|-0.64||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.640|-1.444|
71730931|NCT00098722|142976451|SUPERIORITY_OR_OTHER||LS mean difference|-0.961|STANDARD_ERROR_OF_MEAN|0.1856|||TWO_SIDED|97.5|-1.379|-0.544||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.544|-1.379|
71658736|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-12.7|||<|0.001|TWO_SIDED|95.0|-18.5|-7.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-7.0|-18.5|<0.001
71730932|NCT00098722|142976451|SUPERIORITY_OR_OTHER||LS mean difference|-1.109|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|97.5|-1.523|-0.695||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.695|-1.523|
71730933|NCT00098722|142976452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|95.0|2.56|8.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||8.23|2.56|<0.0001
71771961|NCT03101267|143043941|SUPERIORITY||Adjusted mean difference|0.03||||0.83|TWO_SIDED|95.0|-0.24|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.30|-0.24|0.830
71771962|NCT03101267|143043941|SUPERIORITY||Adjusted mean difference|0.17||||0.208|TWO_SIDED|95.0|-0.1|0.44|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 155||0.44|-0.10|0.208
71771963|NCT03101267|143043941|SUPERIORITY||Adjusted mean difference|0.06||||0.616|TWO_SIDED|95.0|-0.19|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.31|-0.19|0.616
71771964|NCT03101267|143043941|SUPERIORITY||Adjusted mean difference|0.16||||0.207|TWO_SIDED|95.0|-0.09|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Itchy eyes treatment comparison at day 183||0.41|-0.09|0.207
71771965|NCT03101267|143043942|SUPERIORITY||Adjusted mean difference|0.15||||0.157|TWO_SIDED|95.0|-0.06|0.35|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.35|-0.06|0.157
71771966|NCT03101267|143043942|SUPERIORITY||Adjusted mean difference|0.21||||0.039|TWO_SIDED|95.0|0.01|0.41|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 127||0.41|0.01|0.039
71771967|NCT03101267|143043942|SUPERIORITY||Adjusted mean difference|0.08||||0.459|TWO_SIDED|95.0|-0.14|0.3|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.30|-0.14|0.459
71771968|NCT03101267|143043942|SUPERIORITY||Adjusted mean difference|0.16||||0.153|TWO_SIDED|95.0|-0.06|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 155||0.38|-0.06|0.153
71771969|NCT03101267|143043942|SUPERIORITY||Adjusted mean difference|0.12||||0.195|TWO_SIDED|95.0|-0.06|0.31|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.31|-0.06|0.195
71831342|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4043|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.38|0.4043
71771970|NCT03101267|143043942|SUPERIORITY||Adjusted mean difference|0.2||||0.038|TWO_SIDED|95.0|0.01|0.38|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||Watery eyes treatment comparison at day 183||0.38|0.01|0.038
71771971|NCT03101267|143043943|SUPERIORITY||Adjusted mean difference|0.37||||0.433|TWO_SIDED|95.0|-0.56|1.29|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.29|-0.56|0.433
71771972|NCT03101267|143043943|SUPERIORITY||Adjusted mean difference|0.33||||0.479|TWO_SIDED|95.0|-0.59|1.24|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 127||1.24|-0.59|0.479
71831343|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7663|TWO_SIDED|95.0|-0.31|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.23|-0.31|0.7663
71831344|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7415|TWO_SIDED|95.0|-0.31|0.22|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.31|0.7415
71831345|NCT02528188|143167438|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8688|TWO_SIDED|95.0|-0.24|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.24|0.8688
71658737|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-5.1||||0.048|TWO_SIDED|95.0|-10.2|-0.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-10.2|0.048
71771973|NCT03101267|143043943|SUPERIORITY||Adjusted mean difference|0.22||||0.648|TWO_SIDED|95.0|-0.71|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.71|0.648
71771974|NCT03101267|143043943|SUPERIORITY||Adjusted mean difference|0.21||||0.654|TWO_SIDED|95.0|-0.72|1.14|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 155||1.14|-0.72|0.654
71771975|NCT03101267|143043943|SUPERIORITY||Adjusted mean difference|0.27||||0.514|TWO_SIDED|95.0|-0.55|1.09|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.09|-0.55|0.514
71771976|NCT03101267|143043943|SUPERIORITY||Adjusted mean difference|0.35||||0.4|TWO_SIDED|95.0|-0.47|1.17|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||5TSS treatment comparison at day 183||1.17|-0.47|0.400
71730934|NCT00098722|142976452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.01|||<|0.0001|TWO_SIDED|95.0|3.35|10.78|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||10.78|3.35|<0.0001
71730935|NCT00098722|142976452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.25|7.2|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.20|2.25|<0.0001
71730936|NCT00098722|142976452|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.41|||<|0.0001|TWO_SIDED|95.0|2.47|7.85|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.85|2.47|<0.0001
71730937|NCT00098722|142976453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.69|||<|0.0001|TWO_SIDED|95.0|2.72|8.1|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.10|2.72|<0.0001
71730938|NCT00098722|142976453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.91|8.62|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.62|2.91|<0.0001
71658738|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-9.6|||<|0.001|TWO_SIDED|95.0|-14.2|-5.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-5.1|-14.2|<0.001
71730939|NCT00098722|142976453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.0001|TWO_SIDED|95.0|2.13|6.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.32|2.13|<0.0001
71730940|NCT00098722|142976453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.0001|TWO_SIDED|95.0|2.69|8.02|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.02|2.69|<0.0001
71730941|NCT00098722|142976454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|2.64|7.92|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.64|<0.0001
71771977|NCT03101267|143043944|SUPERIORITY||Adjusted mean difference,|0.39||||0.505|TWO_SIDED|95.0|-0.76|1.54||The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.|MMRM|||6TSS treatment comparison at day 127||1.54|-0.76|0.505
71771978|NCT03101267|143043944|SUPERIORITY||Adjusted mean difference,|0.44||||0.451|TWO_SIDED|95.0|-0.71|1.58|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 127||1.58|-0.71|0.451
71771979|NCT03101267|143043944|SUPERIORITY||Adjusted mean difference,|0.29||||0.623|TWO_SIDED|95.0|-0.88|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.88|0.623
71771980|NCT03101267|143043944|SUPERIORITY||Adjusted mean difference,|0.29||||0.62|TWO_SIDED|95.0|-0.87|1.46|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 155||1.46|-0.87|0.620
71730942|NCT00098722|142976454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|95.0|3.13|9.39|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||9.39|3.13|<0.0001
71730943|NCT00098722|142976454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.01|||<|0.0001|TWO_SIDED|95.0|2.29|7.0|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.00|2.29|<0.0001
71771981|NCT03101267|143043944|SUPERIORITY||Adjusted mean difference,|0.35||||0.504|TWO_SIDED|95.0|-0.68|1.37|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.37|-0.68|0.504
71771982|NCT03101267|143043944|SUPERIORITY||Adjusted mean difference,|0.42||||0.414|TWO_SIDED|95.0|-0.6|1.45|||MMRM|The MMRM model included treatment group, stratification factors, analysis visit and interaction of treatment group and analysis visit.||6TSS treatment comparison at day 183||1.45|-0.60|0.414
71658739|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-4.8|||<|0.001|TWO_SIDED|95.0|-7.9|-2.7|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Swelling: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-2.7|-7.9|<0.001
71658740|NCT00546572|142832801|SUPERIORITY_OR_OTHER||Chan & Zhang|-6.8||||0.062|TWO_SIDED|95.0|-14.0|0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||0.4|-14.0|0.062
71658741|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-4.0||||0.284|TWO_SIDED|95.0|-11.3|3.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||3.3|-11.3|0.284
71730944|NCT00098722|142976454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.08|||<|0.0001|TWO_SIDED|95.0|2.91|8.89|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.89|2.91|<0.0001
71658742|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-16.1|||<|0.001|TWO_SIDED|95.0|-21.7|-10.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-10.6|-21.7|<0.001
71730945|NCT00098722|142976455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|1.95|6.48|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.48|1.95|<0.0001
71730946|NCT00098722|142976455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.0005|TWO_SIDED|95.0|1.59|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio \>1 favors maraviroc.||5.23|1.59|0.0005
71730947|NCT00098722|142976455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.26|7.92|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.92|2.26|<0.0001
71730948|NCT00098722|142976455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.2|7.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.64|2.20|<0.0001
71730949|NCT00098722|142976457|SUPERIORITY_OR_OTHER||LS mean difference|47.94|STANDARD_ERROR_OF_MEAN|13.383|||TWO_SIDED|95.0|21.64|74.25||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||74.25|21.64|
71730950|NCT00098722|142976457|SUPERIORITY_OR_OTHER||LS mean difference|38.12|STANDARD_ERROR_OF_MEAN|13.313|||TWO_SIDED|95.0|11.96|64.28||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||64.28|11.96|
71730951|NCT00098722|142976457|SUPERIORITY_OR_OTHER||LS mean difference|52.15|STANDARD_ERROR_OF_MEAN|14.803|||TWO_SIDED|95.0|23.06|81.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||81.25|23.06|
71730952|NCT00098722|142976457|SUPERIORITY_OR_OTHER||LS mean difference|58.46|STANDARD_ERROR_OF_MEAN|14.725|||TWO_SIDED|95.0|29.53|87.4||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||87.40|29.53|
71730953|NCT00098722|142976458|SUPERIORITY_OR_OTHER||LS mean difference|218.57|STANDARD_ERROR_OF_MEAN|71.225|||TWO_SIDED|95.0|78.59|358.54||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||358.54|78.59|
71658743|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-0.9||||0.539|TWO_SIDED|95.0|-3.5|1.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Pain: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||1.4|-3.5|0.539
71658744|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-17.1|||<|0.001|TWO_SIDED|95.0|-23.1|-11.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: any; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-11.1|-23.1|<0.001
71658745|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-14.9|||<|0.001|TWO_SIDED|95.0|-20.8|-9.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: mild; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-9.0|-20.8|<0.001
71730954|NCT00098722|142976458|SUPERIORITY_OR_OTHER||LS mean difference|133.22|STANDARD_ERROR_OF_MEAN|70.855|||TWO_SIDED|95.0|-6.03|272.47||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||272.47|-6.03|
71730955|NCT00098722|142976458|SUPERIORITY_OR_OTHER||LS mean difference|136.93|STANDARD_ERROR_OF_MEAN|57.85|||TWO_SIDED|95.0|23.24|250.62||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||250.62|23.24|
71730956|NCT00098722|142976458|SUPERIORITY_OR_OTHER||LS mean difference|140.25|STANDARD_ERROR_OF_MEAN|57.55|||TWO_SIDED|95.0|27.15|253.35||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||253.35|27.15|
71730957|NCT00098722|142976459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.29|0.56|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.56|0.29|<0.0001
71730958|NCT00098722|142976459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.23|0.46|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.46|0.23|<0.0001
71730959|NCT00098722|142976460|SUPERIORITY_OR_OTHER||LS mean difference|-0.876|STANDARD_ERROR_OF_MEAN|0.1534|||TWO_SIDED|95.0|-1.177|-0.575||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.575|-1.177|
71730960|NCT00098722|142976460|SUPERIORITY_OR_OTHER||LS mean difference|-0.882|STANDARD_ERROR_OF_MEAN|0.1521|||TWO_SIDED|95.0|-1.181|-0.584||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.584|-1.181|
71730961|NCT00098722|142976460|SUPERIORITY_OR_OTHER||LS mean difference|-0.855|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.189|-0.521||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.521|-1.189|
71730962|NCT00098722|142976460|SUPERIORITY_OR_OTHER||LS mean difference|-1.033|STANDARD_ERROR_OF_MEAN|0.1685|||TWO_SIDED|95.0|-1.364|-0.701||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.701|-1.364|
71771983|NCT01262352|143043965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.069||||0.0004|TWO_SIDED|95.0|-2.98|-1.15|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a mixed effect model. The model included the absolute change from the baseline in each period as the dependent variable, sequence, treatment, and period as fixed effects, study baseline LCI as the covariate, and subject nested within sequence as the random effect.||-1.15|-2.98|0.0004
71730963|NCT02351349|142976470|OTHER|paired t test pre compared to post readings||||||0.0143|||||||t-test, 2 sided|||||||0.0143
71888900|NCT02939131|143298772|SUPERIORITY||Mean Difference (Final Values)|52.48||||0.02|TWO_SIDED|95.0|10.46|94.5||This is the test of effect modification by CD4 Nadir stage at study entry.|t-test, 2 sided||A positive value reflects a larger treatment response among those with Stage 3 Nadir CD4 compared to those with less than Stage 3 Nadir CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR response, a positive treatment effect is a positive difference between groups.||94.50|10.46|0.02
71888901|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|-45.06||||0.09|TWO_SIDED|95.0|-97.84|7.72||This is the test of effect modification by sex at birth|t-test, 2 sided||A negative value indicates a greater treatment effect (higher percent with remission for COMB-R than for ESC) among females.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||7.72|-97.84|0.09
71730964|NCT02351349|142976471|OTHER|as above||||||0.1416|||||||t-test, 2 sided|||pre and post comparison of time up and go in intervention group||||0.1416
71730965|NCT02351349|142976472|OTHER|||||||0.9013|||||||t-test, 2 sided|||pre and post value comparison with paired t test was carried out||||0.9013
71730966|NCT01610596|142976478|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71730967|NCT01519674|142976482|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.24||||0.011||95.0|0.06|0.43||No corrections for multiplicity were performed.|Regression, Linear|||"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:~H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met)."||0.43|0.06|0.011
71730968|NCT01519674|142976482|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.11||||0.231||95.0|-0.3|0.07|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||0.07|-0.30|0.231
71730969|NCT01519674|142976482|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.36|||<|0.001||95.0|-0.54|-0.17|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).||-0.17|-0.54|<0.001
71771984|NCT01262352|143043966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.007||||0.0117|TWO_SIDED|95.0|1.8|12.21||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for this efficacy variable was performed in a similar way as the analysis for the primary efficacy variable.||12.21|1.80|0.0117
71771985|NCT01262352|143043967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.848|||<|0.0001|TWO_SIDED|95.0|-53.54|-38.16||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for change from baseline in average sweat chloride was similar to the analysis of the primary efficacy variable.||-38.16|-53.54|<0.0001
71771986|NCT01262352|143043968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.991||||0.3796|TWO_SIDED|95.0|-5.4|13.39||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||The raw scores in CFQ-R were summarized into different domains of health (12 domains for adolescents and adults 14 years of age and older, 8 domains for children ages 12 and 13 years, 8 domains for children ages 6 to 11 years, and 11 domains for parents/caregivers). Each domain was analyzed in a similar way as for the primary efficacy variable. The primary analytical focus was the respiratory health domain which was analyzed by combining all self-response questionnaire versions.||13.39|-5.40|0.3796
71771987|NCT00107952|143043973|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|-1.6||||||95.0|-8.6|5.5||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||5.5|-8.6|
71771988|NCT03614975|143044002|OTHER|||||||0.28||||||A/H1N1|Chi-squared|||||||0.28
71771989|NCT03614975|143044002|OTHER|||||||0.64||||||A/H3N2|Chi-squared|||||||0.64
71771990|NCT03614975|143044002|OTHER|||||||0.64||||||B/Colorado|Chi-squared|||||||0.64
71730970|NCT01519674|142976483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.022||95.0|0.39|0.93|||Regression, Logistic|||||0.93|0.39|0.022
71730971|NCT01519674|142976483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.618||95.0|0.73|1.71|||Regression, Logistic|||||1.71|0.73|0.618
71771991|NCT03614975|143044002|OTHER|||||||0.23||||||B/Phuket|Chi-squared|||||||0.23
71771992|NCT03614975|143044003|OTHER|||||||0.42||||||Vaccine Strain: A/H1N1:Day 0|Chi-squared|||||||0.42
71771993|NCT03614975|143044003|OTHER|||||||0.16||||||Vaccine Strain: A/H1N1: Day 21|Chi-squared|||||||0.16
71831346|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.3622|TWO_SIDED|95.0|-0.25|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.09|-0.25|0.3622
71831347|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.3894|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.09|0.3894
71831348|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.09||0.0137|TWO_SIDED|95.0|-0.42|-0.05|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.42|0.0137
71730972|NCT01519674|142976483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.005||95.0|1.2|2.85|||Regression, Logistic|||||2.85|1.20|0.005
71730973|NCT01519674|142976484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.02||95.0|0.38|0.92|||Regression, Logistic|||||0.92|0.38|0.020
71730974|NCT01519674|142976484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.286||95.0|0.81|2.07|||Regression, Logistic|||||2.07|0.81|0.286
71730975|NCT01519674|142976484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||<|0.001||95.0|1.39|3.47|||Regression, Logistic|||||3.47|1.39|<0.001
71730976|NCT01519674|142976485|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.13||||0.52||95.0|-0.26|0.52|||Regression, Linear|||||0.52|-0.26|0.520
71730977|NCT01519674|142976485|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.05||||0.788||95.0|-0.34|0.45|||Regression, Linear|||||0.45|-0.34|0.788
71730978|NCT01519674|142976485|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.07||||0.708||95.0|-0.46|0.31|||Regression, Linear|||||0.31|-0.46|0.708
71771994|NCT03614975|143044003|OTHER|||||||0.42||||||Vaccine Strain: A/H3N2: Day 0|Chi-squared|||||||0.42
71771995|NCT03614975|143044003|OTHER|||||||0.94||||||Vaccine Strain: A/H3N2: Day 21|Chi-squared|||||||0.94
71771996|NCT03614975|143044003|OTHER|||||||0.87||||||Vaccine Strain: B/Colorado :Day 0|Chi-squared|||||||0.87
71771997|NCT03614975|143044003|OTHER|||||||0.77||||||Vaccine Strain: B/Colorado : Day 21|Chi-squared|||||||0.77
71771998|NCT03614975|143044003|OTHER|||||||0.33||||||Vaccine Strain: B/Phuket: Day 0|Chi-squared|||||||0.33
71771999|NCT03614975|143044003|OTHER|||||||0.21||||||Vaccine Strain: B/Phuket: Day 21|Chi-squared|||||||0.21
71772000|NCT03614975|143044004|OTHER|||||||0.49||||||Vaccine Strain: A/H1N1: Day 0|Kruskal-Wallis|||||||0.49
71772001|NCT03614975|143044004|OTHER|||||||0.23||||||Vaccine Strain: A/H1N1: Day 21|Kruskal-Wallis|||||||0.23
71772002|NCT03614975|143044004|OTHER|||||||0.1||||||Vaccine Strain: A/H3N2: Day 0|Kruskal-Wallis|||||||0.10
71772003|NCT03614975|143044004|OTHER|||||||0.86||||||Vaccine Strain: A/H3N2: Day 21|Kruskal-Wallis|||||||0.86
71772004|NCT03614975|143044004|OTHER|||||||0.73||||||Vaccine Strain: B/Colorado: Day 0|Kruskal-Wallis|||||||0.73
71772005|NCT03614975|143044004|OTHER|||||||0.67||||||Vaccine Strain: B/Colorado: Day 21|Kruskal-Wallis|||||||0.67
71772006|NCT03614975|143044004|OTHER|||||||0.36||||||Vaccine Strain: B/Phuket: Day 0|Kruskal-Wallis|||||||0.36
71772007|NCT03614975|143044004|OTHER|||||||0.65||||||Vaccine Strain: B/Phuket: Day 21|Kruskal-Wallis|||||||0.65
71658746|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.02|TWO_SIDED|95.0|-4.8|-0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: moderate; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.4|-4.8|0.020
71658747|NCT00546572|142832801|SUPERIORITY_OR_OTHER||difference in proportions|-2.3||||0.042|TWO_SIDED|95.0|-4.9|-0.1|||Limitation of arm movement: any; differe||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Limitation of arm movement: severe; difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.1|-4.9|0.042
71730979|NCT01519674|142976486|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.28||||0.291||95.0|-0.24|0.81|||Regression, Linear|||||0.81|-0.24|0.291
71772008|NCT01569464|143044011|SUPERIORITY_OR_OTHER||LS Mean|-0.27|STANDARD_ERROR_OF_MEAN|1.36||0.8451|TWO_SIDED|95.0|-2.96|2.42||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||2.42|-2.96|0.8451
71658748|NCT00546572|142832806|SUPERIORITY_OR_OTHER||difference in proportions|-7.9||||0.034|TWO_SIDED|95.0|-15.2|-0.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|New generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.6|-15.2|0.034
71658749|NCT00546572|142832806|SUPERIORITY_OR_OTHER||difference in proportions|-6.9||||0.039|TWO_SIDED|95.0|-13.6|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan \& Zhang) for the difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.|Aggravated generalized muscle pain: difference in proportions, \[13vPnC\] - \[23vPS\], expressed as a percentage.||-0.3|-13.6|0.039
71730980|NCT01519674|142976486|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.88||||0.001||95.0|-1.41|-0.35|||Regression, Linear|||||-0.35|-1.41|0.001
71730981|NCT01519674|142976486|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.16|||<|0.001||95.0|-1.69|-0.64|||Regression, Linear|||||-0.64|-1.69|<0.001
71730982|NCT01519674|142976487|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.85||||0.005||95.0|0.26|1.45|||Regression, Linear|||||1.45|0.26|0.005
71730983|NCT01519674|142976487|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.52||||0.085||95.0|-0.07|1.12|||Regression, Linear|||||1.12|-0.07|0.085
71730984|NCT01519674|142976487|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.33||||0.275||95.0|-0.92|0.26|||Regression, Linear|||||0.26|-0.92|0.275
71730985|NCT01519674|142976488|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.12||||0.674||95.0|-0.7|0.45|||Regression, Linear|||||0.45|-0.70|0.674
71658750|NCT01394952|142832811|SUPERIORITY|"Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis).~Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467."|Hazard Ratio (HR)|0.88||||0.026|TWO_SIDED|95.33|0.79|0.99|||Regression, Cox|||Primary CV endpoint||0.99|0.79|0.026
71730986|NCT01519674|142976488|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.72||||0.015||95.0|0.14|1.3|||Regression, Linear|||||1.30|0.14|0.015
71730987|NCT01519674|142976488|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.84||||0.004||95.0|0.27|1.41|||Regression, Linear|||||1.41|0.27|0.004
71772009|NCT01569464|143044012|SUPERIORITY_OR_OTHER||LS Mean|0.07|STANDARD_ERROR_OF_MEAN|0.34||0.8336|TWO_SIDED|95.0|-0.61|0.75||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.||0.75|-0.61|0.8336
71772010|NCT01390220|143044033|SUPERIORITY|||||||0.0109|||||||Fisher Exact|2-sided||||||0.0109
71772011|NCT01390220|143044034|SUPERIORITY|||||||0.0043|||||||Fisher Exact|2-sided||||||0.0043
71730988|NCT01519674|142976489|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.31||||0.08||95.0|-0.04|0.65|||Regression, Linear|||||0.65|-0.04|0.080
71730989|NCT01519674|142976489|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.09||||0.613||95.0|-0.26|0.43|||Regression, Linear|||||0.43|-0.26|0.613
71730990|NCT01519674|142976489|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.22||||0.213||95.0|-0.56|0.13|||Regression, Linear|||||0.13|-0.56|0.213
71730991|NCT01519674|142976492|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.29||||0.8||95.0|-1.97|2.56|||Regression, Linear|||||2.56|-1.97|0.800
71730992|NCT01519674|142976492|SUPERIORITY_OR_OTHER||Estimated treatment difference|0.02||||0.989||95.0|-2.26|2.29|||Regression, Linear|||||2.29|-2.26|0.989
71730993|NCT01519674|142976492|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.28||||0.809||95.0|-2.52|1.97|||Regression, Linear|||||1.97|-2.52|0.809
71730994|NCT01804582|142976525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Mixed Models Analysis|||An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.||||.15
71730995|NCT01804582|142976526|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.53|TWO_SIDED||||||Mixed Models Analysis||Cohen's d was calculated to measure the estimation parameter.|||||.53
71730996|NCT01804582|142976527|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||.80
71730997|NCT01804582|142976528|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||.33
71772012|NCT01390220|143044035|SUPERIORITY|||||||0.0124|||||||Log Rank|||||||0.0124
71772013|NCT01390220|143044036|SUPERIORITY|||||||0.0124|||||||Log Rank|||Kaplan-Meier estimates.||||0.0124
71730998|NCT01804582|142976529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wald Chi-Squared|||||||.21
71730999|NCT01804582|142976530|SUPERIORITY_OR_OTHER_LEGACY||Phi|0.19||||0.005|TWO_SIDED||||||Chi-squared|Chi Squared (1, N = 229) = 7.99.||The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)||||.005
71731000|NCT02699450|142976596|SUPERIORITY||Difference in Least Squares Means|1.4||||0.37|TWO_SIDED|80.0|-0.6|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-0.6|0.37
71731001|NCT02699450|142976596|SUPERIORITY||Difference in Least Squares Means|3.6||||0.03|TWO_SIDED|80.0|1.5|5.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.6|1.5|0.03
71731002|NCT02699450|142976597|SUPERIORITY||Difference in Least Squares Means|1.3||||0.63|TWO_SIDED|80.0|-2.3|5.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.0|-2.3|0.63
71731003|NCT02699450|142976598|SUPERIORITY||Difference in Least Squares Means|2.3||||0.15|TWO_SIDED|80.0|0.2|4.3||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.3|0.2|0.15
71731004|NCT02699450|142976598|SUPERIORITY||Difference in Least Squares Means|2.9||||0.04|TWO_SIDED|80.0|1.1|4.7||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline BCVA.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.7|1.1|0.04
71739108|NCT00988091|142991038|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.89||||0.175|TWO_SIDED|95.0|-1.29|7.08||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||7.08|-1.29|0.175
71739109|NCT00988091|142991039|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.777||||0.193|TWO_SIDED|95.0|0.532|1.136||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||1.136|0.532|0.193
71739110|NCT00988091|142991040|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Cochran-Mantel-Haenszel|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||||0.887
71831349|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0106|TWO_SIDED|95.0|-0.43|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.06|-0.43|0.0106
71739111|NCT00988091|142991042|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.0||||0.116|TWO_SIDED|95.0|-0.99|8.98||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.||8.98|-0.99|0.116
71731005|NCT02699450|142976599|SUPERIORITY||Difference in Least Squares Means|0.8||||0.94|TWO_SIDED|80.0|-11.3|12.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||12.8|-11.3|0.94
71658751|NCT01394952|142832812|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.91||||0.211|TWO_SIDED|95.0|0.78|1.06|||Regression, Cox|||Death from CV causes||1.06|0.78|0.211
71772014|NCT01856023|143044110|SUPERIORITY|one -sample binomial test - 1-year estimated OS for these 28 patients was 75% (95%CI: 51%, 88%)||||||0.001||||||compared to the historical control rate of 46% one year survival|Log Rank|||OS rates of the Evaluable population in entire cohort was compared with the historical control rate of 46% (Hodi, et al NEJM 2010) using a one-sample binomial test due to early termination of enrollment without reaching target accrual; planned analysis to be the difference between treatment arms using log-rank test. One year OS along with 95% CI estimated for entire population and each treatment arm separately.||||.001
71831350|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7179|TWO_SIDED|95.0|-0.23|0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.16|-0.23|0.7179
71831351|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.44|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-0.44|0.0120
71831352|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.11||0.5372|TWO_SIDED|95.0|-0.28|0.15|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.15|-0.28|0.5372
71731006|NCT02699450|142976599|SUPERIORITY||Difference in Least Squares Means|7.3||||0.46|TWO_SIDED|80.0|-5.4|19.9||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.9|-5.4|0.46
71731007|NCT02699450|142976600|SUPERIORITY||Difference in Percentage of Participants|6.4||||0.56|TWO_SIDED|80.0|-7.7|20.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||20.5|-7.7|0.56
71731008|NCT02699450|142976601|SUPERIORITY||Difference in Least Squares Means|6.6||||0.43|TWO_SIDED|80.0|-4.0|17.2||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.2|-4.0|0.43
71731009|NCT02699450|142976601|SUPERIORITY||Difference in Least Squares Means|7.2||||0.34|TWO_SIDED|80.0|-2.6|17.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||17.0|-2.6|0.34
71731010|NCT02699450|142976602|SUPERIORITY||Difference in Least Squares Means|9.5||||0.27|TWO_SIDED|80.0|-1.6|20.6||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||20.6|-1.6|0.27
71731011|NCT02699450|142976602|SUPERIORITY||Difference in Least Squares Means|6.8||||0.45|TWO_SIDED|80.0|-4.9|18.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||18.5|-4.9|0.45
71731012|NCT02699450|142976603|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.96|TWO_SIDED|80.0|-16.8|15.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||15.5|-16.8|0.96
71731013|NCT02699450|142976604|SUPERIORITY||Difference in Least Squares Means|9.9||||0.19|TWO_SIDED|80.0|0.1|19.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||19.7|0.1|0.19
71731014|NCT02699450|142976604|SUPERIORITY||Difference in Least Squares Means|4.2||||0.57|TWO_SIDED|80.0|-5.3|13.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||13.6|-5.3|0.57
71731015|NCT02699450|142976605|SUPERIORITY||Difference in Least Squares Means|-2.8||||0.64|TWO_SIDED|80.0|-10.5|4.9||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.9|-10.5|0.64
71772015|NCT04718103|143044122|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted Forced Expiratory Volume in one second (FEV1) and offset of log (total time in the study in years).|Rate Ratio|0.52|||<|0.001|TWO_SIDED|95.0|0.36|0.73|||Negative Binomial Distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.73|0.36|<0.001
71772016|NCT04718103|143044123|SUPERIORITY||Least-square (LS) means|-2.31||||0.2|TWO_SIDED|95.0|-5.84|1.23|||Mixed Models Repeated Measures (MMRM)|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by SGRQ Total Score measured over the study intervention period of 52 weeks.||1.23|-5.84|0.200
71772017|NCT04718103|143044124|SUPERIORITY||Difference in Least-Square Mean|-0.11||||0.333|TWO_SIDED|95.0|-0.33|0.11|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.11|-0.33|0.333
71772018|NCT04718103|143044125|SUPERIORITY||Difference in Least-Square Means|0.056||||0.267|TWO_SIDED|95.0|-0.043|0.154|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.154|-0.043|0.267
71831353|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0899|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.03|-0.40|0.0899
71658752|NCT01394952|142832812|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.96||||0.652|TWO_SIDED|95.0|0.79|1.16|||Regression, Cox|||Nonfatal MI||1.16|0.79|0.652
71658753|NCT01394952|142832812|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.76||||0.017|TWO_SIDED|95.0|0.61|0.95|||Regression, Cox|||Nonfatal stroke||0.95|0.61|0.017
71731016|NCT02699450|142976605|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.78|TWO_SIDED|80.0|-9.8|6.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.2|-9.8|0.78
71731017|NCT02699450|142976606|SUPERIORITY||Difference in Least Squares Means|-2.3||||0.78|TWO_SIDED|80.0|-12.7|8.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||8.2|-12.7|0.78
71731018|NCT02699450|142976607|SUPERIORITY||Difference in Least Squares Means|-0.5||||0.93|TWO_SIDED|80.0|-7.7|6.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||6.7|-7.7|0.93
71731019|NCT02699450|142976607|SUPERIORITY||Difference in Least Squares Means|-2.0||||0.69|TWO_SIDED|80.0|-8.3|4.4||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction term.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||4.4|-8.3|0.69
71731020|NCT02699450|142976608|SUPERIORITY||Difference in Least Squares Means|-6.5||||0.69|TWO_SIDED|80.0|-27.8|14.7||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||14.7|-27.8|0.69
71731021|NCT02699450|142976608|SUPERIORITY||Difference in Least Squares Means|-22.8||||0.18|TWO_SIDED|80.0|-44.5|-1.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-1.2|-44.5|0.18
71731022|NCT02699450|142976609|SUPERIORITY||Difference in Least Squares Means|-49.2||||0.07|TWO_SIDED|80.0|-84.2|-14.2||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-14.2|-84.2|0.07
71731023|NCT02699450|142976610|SUPERIORITY||Difference in Least Squares Means|-17.3||||0.28|TWO_SIDED|80.0|-38.0|3.4||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.4|-38.0|0.28
71731024|NCT02699450|142976610|SUPERIORITY||Difference in Least Squares Means|-29.2||||0.05|TWO_SIDED|80.0|-47.8|-10.6||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline FCPT.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-10.6|-47.8|0.05
71772019|NCT04718103|143044126|SUPERIORITY||Difference in Least square means|-0.21||||0.173|TWO_SIDED|95.0|-0.52|0.09|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.09|-0.52|0.173
71731025|NCT02699450|142976611|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.36|TWO_SIDED|80.0|-29.7|5.0||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||5.0|-29.7|0.36
71731026|NCT02699450|142976611|SUPERIORITY||Difference in Least Squares Means|-21.1||||0.13|TWO_SIDED|80.0|-38.7|-3.5||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.5|-38.7|0.13
71731027|NCT02699450|142976612|SUPERIORITY||Difference in Least Squares Means|-38.6||||0.07|TWO_SIDED|80.0|-65.9|-11.3||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||-11.3|-65.9|0.07
71731028|NCT02699450|142976613|SUPERIORITY||Difference in Least Squares Means|-20.1||||0.12|TWO_SIDED|80.0|-36.4|-3.8||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-3.8|-36.4|0.12
71731029|NCT02699450|142976613|SUPERIORITY||Difference in Least Squares Means|-26.7||||0.02|TWO_SIDED|80.0|-41.3|-12.0||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Mixed Effects Model of Repeated Measures|Categorical covariates: treatment group, categorical visit, and visit by treatment group, stratification factors; continuous covariate: baseline CST.|The mean difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-12.0|-41.3|0.02
71731030|NCT02699450|142976614|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.4948|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4948
71731031|NCT02699450|142976614|SUPERIORITY||Difference in Percentage of Participants|-4.08||||0.496|TWO_SIDED|80.0|-7.7|-0.46||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||-0.46|-7.70|0.4960
71731032|NCT02699450|142976615|SUPERIORITY||Difference in Percentage of Participants|-2.8||||1|TWO_SIDED|80.0|-11.08|5.49||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||5.49|-11.08|1.0000
71731033|NCT02699450|142976616|SUPERIORITY||Difference in Percentage of Participants|-6.12||||0.5759|TWO_SIDED|80.0|-15.41|3.17||There was no formal correction for multiple comparisons. Test for Arm B vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm B minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||3.17|-15.41|0.5759
71731034|NCT02699450|142976616|SUPERIORITY||Difference in Percentage of Participants|3.15||||0.7437|TWO_SIDED|80.0|-5.02|11.33||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arms (Arms B and C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): Either of the faricimab treatment arms (Arm B or C) is different from the ranibizumab treatment arm (Arm A).||11.33|-5.02|0.7437
71731035|NCT02699450|142976617|SUPERIORITY||Difference in Percentage of Participants|2.02||||1|TWO_SIDED|80.0|-8.6|12.64||There was no formal correction for multiple comparisons. Test for Arm C vs. Arm A was carried out at one-sided 10% alpha.|Fisher Exact||The difference between arms was calculated as Arm C minus Arm A.|Null hypothesis (H0): There is no difference between either of the faricimab treatment arm (Arm C) and the active comparator ranibizumab treatment arm (Arm A). The alternative hypothesis (Ha): The faricimab treatment arms (Arm C) is different from the ranibizumab treatment arm (Arm A).||12.64|-8.60|1.0000
71731036|NCT01344629|142976642|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|100.9||||||90.0|97.7|104.2||No statistical test|ANOVA|||||104.2|97.7|
71772020|NCT04718103|143044127|SUPERIORITY||Difference in Least square means|-0.21||||0.138|TWO_SIDED|95.0|-0.48|0.07|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.07|-0.48|0.138
71772021|NCT04718103|143044128|SUPERIORITY|Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region and baseline pre-bronchodilator percent predicted FEV1.|Rate Ratio|0.42||||0.087|TWO_SIDED|95.0|0.16|1.13|||Negative binomial distribution|||||1.13|0.16|0.087
71772022|NCT00136604|143044131|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above -10%.|Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.||3.05|-1.53|
71772023|NCT00136604|143044133|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.53|3.05||||||Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.||3.05|-1.53|
71772024|NCT00591578|143044168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||<|0.001|TWO_SIDED|95.0|-5.59|-1.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-1.69|-5.59|<0.001
71772025|NCT00591578|143044168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|||<|0.001|TWO_SIDED|95.0|-6.01|-2.06||Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-2.06|-6.01|<0.001
71772026|NCT00591578|143044169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27||||0.015|TWO_SIDED|95.0|-5.9|-0.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.63|-5.90|0.015
71772027|NCT00591578|143044169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.34|||<|0.001|TWO_SIDED|95.0|-8.0|-2.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.68|-8.00|<0.001
71772028|NCT00591578|143044170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|||<|0.001|TWO_SIDED|95.0|-3.44|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.88|-3.44|<0.001
71772029|NCT00591578|143044170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||<|0.001|TWO_SIDED|95.0|-3.99|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.40|-3.99|<0.001
71772030|NCT00591578|143044171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52||||0.001|TWO_SIDED|95.0|-4.06|-0.98||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.98|-4.06|0.001
71731037|NCT01344629|142976643|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|97.2||||||90.0|87.2|108.3||No statistical test|ANOVA|||||108.3|87.2|
71731038|NCT01344629|142976644|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|101.7||||||90.0|98.3|105.2||No statistical test|ANOVA|||||105.2|98.3|
71772031|NCT00591578|143044171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|||<|0.001|TWO_SIDED|95.0|-4.32|-1.21||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.21|-4.32|<0.001
71772032|NCT00591578|143044172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||<|0.001|TWO_SIDED|95.0|-5.53|-1.44||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.44|-5.53|<0.001
71772033|NCT00591578|143044172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.96|-1.83||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.83|-5.96|<0.001
71831354|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7646|TWO_SIDED|95.0|-0.3|0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.22|-0.30|0.7646
71731039|NCT01344629|142976645|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|110.1||||||90.0|95.8|124.4||No statistical test|ANOVA|||||124.4|95.8|
71731040|NCT01344629|142976646|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|91.4||||||90.0|85.6|97.6||No statistical test|ANOVA|||||97.6|85.6|
71731041|NCT01344629|142976647|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.4||||||90.0|102.4|116.8||No statistical test|ANOVA|||||116.8|102.4|
71731042|NCT01344629|142976648|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.0||||||90.0|101.5|117.1||No statistical test|ANOVA|||||117.1|101.5|
71731043|NCT04063787|142976659|EQUIVALENCE|The null hypothesis is the difference is zero. Thus the equivalence margin equals zero.|Mean Difference (Final Values)|0.408|STANDARD_DEVIATION|1.05||0.012|TWO_SIDED||||||t-test, 2 sided|Paired t-test||Compare before and after use of Fist Assist||||0.012
71731044|NCT05545644|142976663|SUPERIORITY||Hedges g|0.48|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71731045|NCT05545644|142976664|SUPERIORITY||Hedges g|0.37|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71731046|NCT05545644|142976665|SUPERIORITY||Hedges g|0.04|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71731047|NCT05545644|142976665|SUPERIORITY|Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).|Mean Difference (Final Values)|0.19|||||TWO_SIDED||||||||||Hedges g = .04; SE = .42|||
71731048|NCT05545644|142976666|SUPERIORITY||Hedges g|0.44|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|||||Given the small sample size, we relied more heavily on effect size calculations (Hedges g adjusted for small sample bias).||||||||
71731049|NCT02469714|142976668|SUPERIORITY||Mean Difference (Final Values)|0.66||||0.04|TWO_SIDED||||||ANCOVA|||Between group comparison of total scheduled appointments from 1-13 months||||.04
71731050|NCT02469714|142976668|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.008|TWO_SIDED||||||ANCOVA|||Between group comparison of total achieved appointments from 1-13 months||||.008
71731051|NCT02469714|142976669|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.135|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.135
71731052|NCT02469714|142976670|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.077|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.077
71731053|NCT02469714|142976671|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.0005|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.0005
71731054|NCT02469714|142976672|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.06|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.060
71731055|NCT02469714|142976673|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.073|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.073
71731056|NCT02469714|142976674|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.34|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.34
71731057|NCT02469714|142976675|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.21|TWO_SIDED||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.||||.21
71731058|NCT01511809|142976691|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A lower limit of the 95% confidence interval of the difference between the two proportions of treatment failure (triple therapy-monotherapy) below the pre-specified margin of non-inferiority of -10% established inferiority. A sample size of 342 patients (171 per treatment arm) provided 80% power (one-sided, alpha 0.05) to establish non-inferiority of ATV/r monotherapy as compared to ATV/r triple therapy with an overall treatment failure (TF) rate of 15% at week 48.|difference between TF proportions|15.0|||||TWO_SIDED|||||||||"Here are reported the results of the 48-week interim analyses according to the intention-to-treat (ITT) principle. ITT=F (with re-intensification=failure) and the ITT=S (with re-intensification=success) treatment failure results are shown.~Based on the efficacy data review, in June 2013, an independent Data and Safety Monitoring Board (DSMB) recommended to stop further patients' enrolment and to follow-up the enrolled patients until 96 weeks, after having signed an updated informed consent."||||
71731059|NCT02818114|142976701|OTHER|Assessment of number of PE sessions attended, review of direction of change in PTSD Checklist scores||||||||||||||||This is a single-arm feasibility study. With N=8, formal hypothesis testing is not possible. We were assessing the extent to which veterans would be willing to engage in the intervention, and if the direction of change in symptoms is still in the expected direction when peer support services are added. Outcomes are reported more qualitatively.|As a feasibility trial, tests of statistical significance are not appropriate.|||
71731060|NCT02945553|142976737|OTHER|Mixed model analysis of variance|Mean Difference (Final Values)|1596.0|STANDARD_DEVIATION|202.0|<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71731061|NCT02945553|142976742|OTHER||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71731062|NCT03343080|142976758|SUPERIORITY|||||||0.776|||||||Wilcoxon (Mann-Whitney)|||||||0.776
71658754|NCT01394952|142832813|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.9||||0.067|TWO_SIDED|95.0|0.8|1.01|||Regression, Cox|||Time to all cause mortality||1.01|0.80|0.067
71731063|NCT03343080|142976759|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||4 hours post-extubation||||0.296
71731064|NCT01241760|142976760|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.|Difference in proportion of response, %|1.5||||||95.0|-4.9|12.0|||Regression, Logistic|The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.|Observed data|||12|-4.9|
71731065|NCT03780959|142976775|SUPERIORITY|||||||0.003|||||||Mantel Haenszel|Stratified by study center and the number of active joints at randomization||||||0.0030
71731066|NCT03780959|142976776|SUPERIORITY|||||||0.0001|||||||Log Rank|||||||0.0001
71731067|NCT01636713|142976778|SUPERIORITY_OR_OTHER||Least squares mean difference|0.151|||<|0.001|TWO_SIDED|95.0|0.11|0.191|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.191|0.110|<0.001
71731068|NCT01636713|142976778|SUPERIORITY_OR_OTHER||Least squares mean difference|0.216|||<|0.001|TWO_SIDED|95.0|0.175|0.257|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference= UMEC/VI 125/25 µg minus Placebo.|||0.257|0.175|<0.001
71731069|NCT03689244|142976803|SUPERIORITY||Ratio of Geometric LS mean|0.95||||0.412|TWO_SIDED|95.0|0.84|1.07|||ANCOVA|||Ratio of Geometric mean of Selexipag to Placebo was reported.||1.07|0.84|0.412
71731070|NCT02138240|142976809|OTHER|Pre-post comparison|||||<|0.001|||||||Wilcoxon signed rank sum|||||||<0.001
71731071|NCT02138240|142976812|OTHER|Pre-post comparison of baseline median weight to median weight at 6-month follow up||||||0.21|||||||Wilcoxon signed rank sum|||||||0.21
71731072|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.52|
71731073|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.52|
71731074|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.51|5.02||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.51|
71731075|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|4.17|||||TWO_SIDED|95.0|1.37|11.57||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||11.57|1.37|
71731076|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.46|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.||5.09|-2.46|
71731077|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.||5.09|-2.48|
71731078|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-2.48|5.02||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.||5.02|-2.48|
71731079|NCT00969436|142976813|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|2.77|||||TWO_SIDED|95.0|-1.59|10.29||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.||10.29|-1.59|
71731080|NCT02789410|142976824|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
71731081|NCT02789410|142976825|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.590
71772034|NCT00591578|143044173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.002|TWO_SIDED|95.0|-3.54|-0.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.79|-3.54|0.002
71772035|NCT00591578|143044173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67|||<|0.001|TWO_SIDED|95.0|-4.06|-1.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.28|-4.06|<0.001
71731082|NCT02789410|142976826|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
71731083|NCT03159104|142976835|SUPERIORITY||Median Difference (Final Values)|5.0||||0.0113|TWO_SIDED|95.0|1.0|9.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|The difference between final and initial total scholastic skill score was calculated for each participant. Wilcoxon test was used for comparison of these differences because data distribution differs from normal.||9|1|0.0113
71731084|NCT03159104|142976836|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0608|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||5|0|0.0608
71731085|NCT03159104|142976837|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0824|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||0|0|0.0824
71731086|NCT03159104|142976838|SUPERIORITY||Median Difference (Final Values)|0.0||||0.2391|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimator was used for the difference between median change of total scholastic skill score in each comparison group.|||1|0|0.2391
71658755|NCT01394952|142832814|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Regression, Cox|||microvascular endpoint||0.93|0.79|<0.001
71772036|NCT00591578|143044174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79|||<|0.001|TWO_SIDED|95.0|-5.96|-1.62||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.62|-5.96|<0.001
71772037|NCT00591578|143044174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||<|0.001|TWO_SIDED|95.0|-6.63|-2.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-2.24|-6.63|<0.001
71772038|NCT00591578|143044175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.008|TWO_SIDED|95.0|-3.48|-0.53||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.53|-3.48|0.008
71772039|NCT00591578|143044175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|||<|0.001|TWO_SIDED|95.0|-4.33|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.35|-4.33|<0.001
71772040|NCT00591578|143044176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.002|TWO_SIDED|95.0|-5.57|-1.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.30|-5.57|0.002
71731087|NCT03159104|142976839|SUPERIORITY|||||||0.0033|||||||Fisher Exact|||||||0.0033
71731088|NCT03159104|142976840|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||||||0.0012
71731089|NCT01999218|142976844|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares Means|0.1|||||TWO_SIDED|95.0|-0.02|0.22|||||Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.|||0.22|-0.02|
71731090|NCT01999218|142976844|NON_INFERIORITY|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||"Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.~Time was treated as a categorical variable."|||0.30|0.06|
71772041|NCT00591578|143044176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.01|||<|0.001|TWO_SIDED|95.0|-6.16|-1.85||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.85|-6.16|<0.001
71731091|NCT01999218|142976845|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|1.6|||||TWO_SIDED|95.0|-4.5|7.7||||||||7.7|-4.5|
71731092|NCT01999218|142976845|OTHER|Based on Miettinen \& Nurminen method|Difference in % vs. Glimepiride|0.5|||||TWO_SIDED|95.0|-5.6|6.5||||||||6.5|-5.6|
71731093|NCT01999218|142976846|OTHER||Difference in % vs. Glimepiride|3.0|||||TWO_SIDED|95.0|-0.3|6.4||||||||6.4|-0.3|
71731094|NCT01999218|142976846|OTHER||Difference in % vs. Glimepiride|1.5|||||TWO_SIDED|95.0|-1.7|4.7||||||||4.7|-1.7|
71772042|NCT00591578|143044177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.003|TWO_SIDED|95.0|-3.63|-0.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.72|-3.63|0.003
71772043|NCT00591578|143044177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||<|0.001|TWO_SIDED|95.0|-4.2|-1.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.25|-4.20|<0.001
71772044|NCT00591578|143044178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.38||||0.005|TWO_SIDED|95.0|-5.76|-1.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.00|-5.76|0.005
71772045|NCT00591578|143044178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.005|TWO_SIDED|95.0|-5.87|-1.06||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-1.06|-5.87|0.005
71772046|NCT00591578|143044179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.009|TWO_SIDED|95.0|-4.04|-0.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.59|-4.04|0.009
71772047|NCT00591578|143044179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.004|TWO_SIDED|95.0|-4.34|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA|||||-0.84|-4.34|0.004
71658756|NCT01394952|142832815|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.93||||0.456|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox|||Heart failure requiring hospitalization or an urgent heart failure clinic visit||1.12|0.77|0.456
71731095|NCT01999218|142976847|OTHER||Difference in % vs. Glimepiride|-14.0|||<|0.001|TWO_SIDED|95.0|-18.4|-9.8|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-9.8|-18.4|<0.001
71731096|NCT01999218|142976847|OTHER||Difference in % vs. Glimepiride|-16.1|||<|0.001|TWO_SIDED|95.0|-20.3|-12.2|||Based on Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method|-12.2|-20.3|<0.001
71731097|NCT01999218|142976848|OTHER||Difference in LSM vs. Glimepiride|-4.29|||<|0.001|TWO_SIDED|95.0|-4.77|-3.8|||Constrained Longitudinal Data analysis||LSM=Least Squares Means||Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.80|-4.77|<0.001
71731098|NCT01999218|142976848|OTHER||Difference in the LSM vs. Glimepiride|-3.87|||<|0.001|TWO_SIDED|95.0|-4.36|-3.38|||Constrained Longitudinal Data Analysis||||Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.38|-4.36|<0.001
71731099|NCT01999218|142976849|OTHER||Difference in the LSM vs. Glimepiride|-4.77|||<|0.001|TWO_SIDED|95.0|-6.29|-3.25|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-3.25|-6.29|<0.001
71731100|NCT01999218|142976849|OTHER||Difference in the LSM vs. Glimepiride|-3.2|||<|0.001|TWO_SIDED|0.001|-4.73|-1.67|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).|-1.67|-4.73|<0.001
71731101|NCT01800318|142976850|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||RM Anova of effects of treatment groups on PIPP scores: .|ANOVA|||||||0.07
71731102|NCT01800318|142976850|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and sham NESAP.||||<0.05
71731103|NCT01800318|142976850|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with NESAP and oral water.||||<0.01
71731104|NCT01800318|142976850|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and NESAp combined.||||<0.05
71731105|NCT01800318|142976850|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|Bonferroni||t test comparing baseline PIPP score with heel stick PIPP scores in standard care group (Sham NESAP with oral water).||||<0.01
71731106|NCT01800318|142976851|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
71772048|NCT00591578|143044180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.016|TWO_SIDED|95.0|1.07|2.0||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.00|1.07|0.016
71772049|NCT00591578|143044180|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.002|TWO_SIDED|95.0|1.19|2.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.23|1.19|0.002
71831355|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2547|TWO_SIDED|95.0|-0.41|0.11|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.11|-0.41|0.2547
71831356|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8806|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.29|0.8806
71831357|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8416|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8416
71658757|NCT01394952|142832816|SUPERIORITY|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|1.14||||0.413|TWO_SIDED|95.0|0.84|1.54|||Regression, Cox|||Hospitalization for unstable angina||1.54|0.84|0.413
71731107|NCT01800318|142976852|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANOVA|||||||0.9
71731108|NCT01800318|142976854|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANOVA|F4.048||||||0.008
71772050|NCT00591578|143044181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.041|TWO_SIDED|95.0|1.02|2.1||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.10|1.02|0.041
71731109|NCT03809910|142976884|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.09|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.09|<.0001
71731110|NCT03809910|142976885|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.17|-0.07||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.07|-0.17|<0.0001
71731111|NCT03809910|142976886|SUPERIORITY||Adjusted Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.16|-0.06||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.06|-0.16|<0.0001
71731112|NCT03809910|142976887|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|-0.25|-0.19||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.19|-0.25|<0.0001
71731113|NCT03809910|142976888|SUPERIORITY||Adjusted Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.43|-0.33||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.33|-0.43|<0.0001
71731114|NCT03809910|142976889|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|-0.39|-0.29||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.29|-0.39|<0.0001
71731115|NCT03809910|142976890|SUPERIORITY||Adjusted Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.13|0.18||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.18|0.13|<0.0001
71731116|NCT03809910|142976891|SUPERIORITY||Adjusted Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.21|0.31||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.31|0.21|<0.0001
71731117|NCT03809910|142976892|SUPERIORITY||Adjusted Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.18|0.28||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.28|0.18|<0.0001
71772051|NCT00591578|143044181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.015|TWO_SIDED|95.0|1.09|2.28||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.28|1.09|0.015
71772052|NCT00591578|143044182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.018|TWO_SIDED|95.0|1.07|1.99||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||1.99|1.07|0.018
71772053|NCT00591578|143044182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.24|2.33||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.||||2.33|1.24|<0.001
71831358|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.9981|TWO_SIDED|95.0|-0.28|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.28|-0.28|0.9981
71831359|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6485|TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.34|-0.21|0.6485
71831360|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8317|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.30|0.8317
71831361|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5819|TWO_SIDED|95.0|-0.19|0.35|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.35|-0.19|0.5819
71658758|NCT02500641|142832821|SUPERIORITY|||||||0.5298|||||||ANCOVA|||||||0.5298
71831362|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8538|TWO_SIDED|95.0|-0.26|0.31|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.31|-0.26|0.8538
71831363|NCT02528188|143167440|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.15||0.1981|TWO_SIDED|95.0|-0.1|0.47|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.||0.47|-0.10|0.1981
71831364|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0846|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.02|-0.33|0.0846
71888902|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.95|TWO_SIDED|95.0|-43.38|46.2||This is the test of effect modification by age group.|t-test, 2 sided||A positive value would reflect a larger treatment effect among younger participants compared to older participants.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||46.20|-43.38|0.95
71731118|NCT03809910|142976893|SUPERIORITY||Adjusted Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.09|0.15||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.15|0.09|<0.0001
71731119|NCT03809910|142976893|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.0214|TWO_SIDED|95.0|-0.06|0.0||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.00|-0.06|0.0214
71731120|NCT03809910|142976894|SUPERIORITY||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.13|0.23||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.23|0.13|<0.0001
71731121|NCT03809910|142976894|SUPERIORITY||Adjusted Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.001|TWO_SIDED|95.0|-0.14|-0.04||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||-0.04|-0.14|0.0010
71731122|NCT03809910|142976895|SUPERIORITY||Adjusted Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.15|0.25||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.25|0.15|<0.0001
71731123|NCT03809910|142976895|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.026||0.1652|TWO_SIDED|95.0|-0.09|0.01||Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline.|ANCOVA|||||0.01|-0.09|0.1652
71731124|NCT04948307|142976962|SUPERIORITY|||||||0.7326|||||||Chi-squared|||||||0.7326
71731125|NCT04948307|142976963|SUPERIORITY|||||||0.7396|||||||Kolmogorov-Smirnoff|||||||0.7396
71731126|NCT04948307|142976964|SUPERIORITY|||||||0.871|||||||Kolmogorov-Smirnoff|||||||0.8710
71731127|NCT04948307|142976965|SUPERIORITY|||||||0.8816|||||||Kolmogorov-Smirnoff|||||||0.8816
71731128|NCT04948307|142976966|SUPERIORITY|||||||0.5281|||||||Chi-squared|||||||0.5281
71731129|NCT04948307|142976967|SUPERIORITY|||||||0.2996|||||||Chi-squared|||||||0.2996
71731130|NCT04948307|142976971|SUPERIORITY|||||||0.7201|||||||Kolmogorov-Smirnoff|||||||0.7201
71731131|NCT04948307|142976973|OTHER|||||||||||||||||Summary statistics are presented.|Summary statistics are presented|||
71731132|NCT04948307|142976975|OTHER||||||||||||||||||Summary statistics are presented.|||
71731133|NCT03323736|142977002|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.80) exceeded the 68% success rate performance goal.|Credible Interval|0.86|||||TWO_SIDED|95.0|0.8|0.91||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.91|0.80|
71731134|NCT03323736|142977002|SUPERIORITY|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.82) exceeded the 68% success rate performance goal.|Credible Interval|0.89|||||TWO_SIDED|95.0|0.82|0.93||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.||0.93|0.82|
71731135|NCT03323736|142977003|SUPERIORITY|Comparison of mean tube placement FPS-R score to a performance goal of 4.2.||||||0.0072||||||Mean FPS-R score hypothesized to be less than (superior to) a performance goal of 4.2, at a significance level of 0.025 (p\<0.025).|t-test, 1 sided|||||||0.0072
71772054|NCT05038904|143044275|SUPERIORITY|We estimated that 10 subjects allowed for 80% power to detect a 3-fold increase (1.1 natural log units; i.e. 1 food dose escalation) in the threshold food dose using a paired t test with p\<0.05. For this sample size determination, the primary endpoint was assumed to be normally distributed with a standard deviation of 1.1 natural log units.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71772055|NCT05038904|143044276|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||||||0.0014
71731136|NCT03323736|142977004|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>80%, at alpha = 0.025.|mid-P method for single proportion|||Tube Patency endpoint would be successfully met if the percentage of subjects with patent tubes was greater than (superior to) 80% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
71731137|NCT03323736|142977005|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>88%, at alpha = 0.025.|mid-P method for single proportion|||Tube Retention endpoint would be successfully met if the percentage of subjects with retained tubes was greater than (superior to) 88% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
71731138|NCT03323736|142977006|SUPERIORITY||||||<|0.0001||||||Pre-specified threshold for superiority was \>85%, at alpha = 0.025.|mid-P method for single proportion|||The Anesthesia Effectiveness endpoint would be successfully met if the percentage of subjects with successful anesthesia was greater than (superior to) 85% (by subject), at a significance level of 0.025 (p\<0.025).||||<0.0001
71731139|NCT03710876|142977029|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.284|TWO_SIDED|95.0|0.43|1.59||1-sided|Log Rank|||||1.59|0.43|0.2840
71731140|NCT03710876|142977031|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-17.3|24.3||2-sided|Fisher Exact||Risk difference is proportion achieving objective response in r+C+G group minus the proportion achieving objective response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||24.3|-17.3|1.0000
71731141|NCT03710876|142977032|SUPERIORITY||Risk Difference (RD)|2.2||||1|TWO_SIDED|95.0|-25.2|29.2|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||29.2|-25.2|1.0000
71772056|NCT05038904|143044277|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71772057|NCT05038904|143044278|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Participants' ex vivo basophil activation during acalabrutinib treatment was compared to their own baseline level.||||0.002
71772058|NCT02730208|143044365|OTHER|Treatment effect outcomes are estimates.|Least Squares (LS) Mean Difference|-1.48|||||TWO_SIDED|95.0|-7.47|4.52||||||||4.52|-7.47|
71658759|NCT00643565|142832835|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.7189|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.41|0.61|0.7189
71731142|NCT03710876|142977033|SUPERIORITY||Risk Difference (RD)|-7.6||||0.7665|TWO_SIDED|95.0|-34.9|20.3|||Fisher Exact||Risk difference is proportion achieving response in r+C+G group minus the proportion achieving response in C+ G group. The confidence interval was calculated by the exact conditional method of Chan and Zhang.|||20.3|-34.9|0.7665
71731143|NCT03710876|142977034|SUPERIORITY||Risk Difference (RD)|-4.4||||0.7537|TWO_SIDED|95.0|-31.7|23.0||2-sided.|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||23.0|-31.7|0.7537
71731144|NCT03710876|142977035|SUPERIORITY||Risk Difference (RD)|18.4||||0.1855|TWO_SIDED|95.0|-8.8|45.6||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||45.6|-8.8|0.1855
71731145|NCT03710876|142977036|SUPERIORITY||Risk Difference (RD)|12.2||||0.357|TWO_SIDED|95.0|-13.8|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-13.8|0.3570
71731146|NCT03710876|142977037|SUPERIORITY||Risk Difference (RD)|13.5||||0.2856|TWO_SIDED|95.0|-11.3|38.3||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||38.3|-11.3|0.2856
71731147|NCT03710876|142977038|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
71772059|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772060|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772061|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71888903|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|5.59||||0.79|TWO_SIDED|95.0|-40.47|51.65||This is the test of effect modification by viral suppression status.|Wilcoxon (Mann-Whitney)||A positive value would reflect a greater treatment effect among those with suppressed viral load compared to those without viral suppression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.65|-40.47|0.79
71888904|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|-15.97||||0.42|TWO_SIDED|95.0|-58.88|26.94||This is the test of effect modification by QIDS-SR level at entry.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with moderate depression symptomatology at entry compared to those with severe depression.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||26.94|-58.88|0.42
71731148|NCT03710876|142977039|SUPERIORITY||Risk Difference (RD)|6.1||||0.6173|TWO_SIDED|95.0|-17.8|30.0||2-sided|Chi-squared|Variance calculated by Greenwood's method.|Risk difference is estimated probability of survival in r+C+G minus the estimated probability of survival in C+G group.|Percentage proportion calculated by Kaplan-Meier method.||30.0|-17.8|0.6173
71731149|NCT02262078|142977073|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71772062|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772063|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71658760|NCT00643565|142832836|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3211|TWO_SIDED|95.0|0.51|1.25|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.||1.25|0.51|0.3211
71658761|NCT01355159|142832855|SUPERIORITY||Risk Ratio (RR)|1.1||||0.37|TWO_SIDED|95.0|0.9|1.34|||Chi-squared|||||1.34|0.90|0.37
71731150|NCT01688739|142977076|OTHER||Ratio of Geometric Means|1.1||||0.7595|TWO_SIDED|90.0|0.8|1.4|||ANCOVA||Migraine participants / Healthy Participants|||1.4|0.8|0.7595
71731151|NCT01688739|142977078|OTHER||Ratio of Geometric Means|1.1||||0.5481|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5481
71731152|NCT01688739|142977079|OTHER||Ratio of Geometric Means|1.1||||0.5506|TWO_SIDED|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants|||1.4|0.9|0.5506
71731153|NCT00996801|142977081|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.96||||0.012|TWO_SIDED|95.0|-3.58|-0.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.35|-3.58|0.012
71731154|NCT00996801|142977081|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.81||||0.019|TWO_SIDED|95.0|-3.37|-0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.25|-3.37|0.019
71731155|NCT00996801|142977081|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.82||||0.019|TWO_SIDED|95.0|-3.23|-0.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.41|-3.23|0.019
71731156|NCT00996801|142977082|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.64|||<|0.001|TWO_SIDED|95.0|-3.9|-1.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.38|-3.90|<0.001
71731157|NCT00996801|142977082|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.62|||<|0.001|TWO_SIDED|95.0|-3.83|-1.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.40|-3.83|<0.001
71731158|NCT00996801|142977082|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.12|||<|0.001|TWO_SIDED|95.0|-3.22|-1.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.02|-3.22|<0.001
71731159|NCT00996801|142977082|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.74||||0.376|TWO_SIDED|95.0|-1.99|0.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.52|-1.99|0.376
71731160|NCT00996801|142977082|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.71||||0.376|TWO_SIDED|95.0|-1.93|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-1.93|0.376
71831365|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9749|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.18|0.9749
71831366|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0076|TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.07|-0.45|0.0076
71831367|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.54|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.16|-0.54|0.0003
71831368|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.4402|TWO_SIDED|95.0|-0.27|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.12|-0.27|0.4402
71888905|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|9.99||||0.68|TWO_SIDED|95.0|-41.24|61.22||This is the test of effect modification by mode of transmission.|t-test, 2 sided||A positive value would reflect a greater treatment effect among those with perinatal transmission compared to behavioral transmission.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||61.22|-41.24|0.68
71731161|NCT00996801|142977082|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.22||||0.699|TWO_SIDED|95.0|-1.32|0.88||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.88|-1.32|0.699
71731162|NCT00996801|142977083|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.04||||0.002|TWO_SIDED|95.0|-3.43|-0.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.64|-3.43|0.002
71731163|NCT00996801|142977083|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.29||||0.035|TWO_SIDED|95.0|-2.48|-0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.09|-2.48|0.035
71731164|NCT00996801|142977083|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.76||||0.009|TWO_SIDED|95.0|-3.14|-0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.38|-3.14|0.009
71731165|NCT00996801|142977083|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.86||||0.335|TWO_SIDED|95.0|-2.26|0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.54|-2.26|0.335
71731166|NCT00996801|142977083|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.11||||0.857|TWO_SIDED|95.0|-1.3|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-1.30|0.857
71731167|NCT00996801|142977083|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.59||||0.542|TWO_SIDED|95.0|-1.96|0.79||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.79|-1.96|0.542
71731168|NCT00996801|142977084|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.24|||<|0.001|TWO_SIDED|95.0|-4.91|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.91|<0.001
71731169|NCT00996801|142977084|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-3.18|||<|0.001|TWO_SIDED|95.0|-4.78|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.57|-4.78|<0.001
71731170|NCT00996801|142977084|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.66|-1.74||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-1.74|-4.66|<0.001
71831369|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.21|-0.61|<0.0001
71731171|NCT00996801|142977084|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.27||||0.18|TWO_SIDED|95.0|-2.93|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.93|0.180
71772064|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772065|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772066|NCT00245219|143044367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772067|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772068|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772069|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71831370|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.11||0.1543|TWO_SIDED|95.0|-0.38|0.06|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.06|-0.38|0.1543
71658762|NCT01355159|142832857|SUPERIORITY||Risk Ratio (RR)|1.29||||0.37|TWO_SIDED|95.0|0.74|2.28|||Chi-squared|||||2.28|0.74|0.37
71731172|NCT00996801|142977084|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.2||||0.18|TWO_SIDED|95.0|-2.81|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.40|-2.81|0.180
71731173|NCT00996801|142977084|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.22||||0.18|TWO_SIDED|95.0|-2.68|0.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.23|-2.68|0.180
71731174|NCT00996801|142977085|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.36||||0.001|TWO_SIDED|95.0|-2.18|-0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.54|-2.18|0.001
71731175|NCT00996801|142977085|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.51||||0.001|TWO_SIDED|95.0|-2.46|-0.55||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.55|-2.46|0.001
71731176|NCT00996801|142977085|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.93|-0.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.91|-2.93|<0.001
71731177|NCT00996801|142977085|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.383|TWO_SIDED|95.0|-1.21|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-1.21|0.383
71831371|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||-0.09|-0.53|0.0053
71888906|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|-14.21||||0.57|TWO_SIDED|95.0|-70.62|42.2||This is the test of effect modification by HIV CDC stage.|t-test, 2 sided||A positive value would reflect a greater treatment response among those with HIV CDC Stage 3 classification compared to those with less than Stage 3 classification.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||42.20|-70.62|0.57
71658763|NCT01355159|142832858|SUPERIORITY||Risk Ratio (RR)|0.64||||0.21|TWO_SIDED|95.0|0.31|1.31|||Chi-squared|||||1.31|0.31|0.21
71658764|NCT01355159|142832859|SUPERIORITY||Risk Ratio (RR)|0.97||||0.71|TWO_SIDED|95.0|0.82|1.15|||Chi-squared|||||1.15|0.82|0.71
71731178|NCT00996801|142977085|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.52||||0.383|TWO_SIDED|95.0|-1.49|0.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.45|-1.49|0.383
71731179|NCT00996801|142977085|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.94||||0.084|TWO_SIDED|95.0|-1.96|0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.09|-1.96|0.084
71731180|NCT00996801|142977086|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.68|TWO_SIDED|95.0|-1.88|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.88|0.680
71772070|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772071|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71831372|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6445|TWO_SIDED|95.0|-0.33|0.2|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.20|-0.33|0.6445
71831373|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1439|TWO_SIDED|95.0|-0.47|0.07|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.07|-0.47|0.1439
71831374|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8402|TWO_SIDED|95.0|-0.3|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.30|0.8402
71658765|NCT01355159|142832860|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.86|1.13|||Chi-squared|||||1.13|0.86|0.87
71658766|NCT01355159|142832861|SUPERIORITY||Risk Ratio (RR)|1.21||||0.75|TWO_SIDED|95.0|0.37|3.96|||Chi-squared|||||3.96|0.37|0.75
71731181|NCT00996801|142977086|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.993|TWO_SIDED|95.0|-1.3|1.28||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.28|-1.30|0.993
71731182|NCT00996801|142977086|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.23|TWO_SIDED|95.0|-2.67|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.46|-2.67|0.230
71658767|NCT01355159|142832862|SUPERIORITY||Risk Ratio (RR)|1.52||||0.19|TWO_SIDED|95.0|0.81|2.84|||Chi-squared|||||2.84|0.81|0.19
71658768|NCT01355159|142832863|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|7.0||0.61|TWO_SIDED|95.0|-0.96|1.63|||t-test, 2 sided|||||1.63|-0.96|0.61
71658769|NCT01355159|142832864|SUPERIORITY||Risk Ratio (RR)|0.6||||0.14|TWO_SIDED|95.0|0.3|1.19|||Chi-squared|||||1.19|0.30|0.14
71658770|NCT01355159|142832865|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.41|1.39|||Chi-squared|||||1.39|0.41|0.37
71658771|NCT01355159|142832866|SUPERIORITY||Risk Ratio (RR)|1.03||||0.82|TWO_SIDED|95.0|0.81|1.3|||Chi-squared|||||1.30|0.81|0.82
71658772|NCT01355159|142832867|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
71658773|NCT01355159|142832868|SUPERIORITY||Risk Ratio (RR)|0.63||||0.07|TWO_SIDED|95.0|0.37|1.05|||Chi-squared|||||1.05|0.37|0.07
71731183|NCT00996801|142977086|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.84||||0.333|TWO_SIDED|95.0|-2.29|0.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.61|-2.29|0.333
71731184|NCT00996801|142977086|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.37||||0.577|TWO_SIDED|95.0|-1.69|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.94|-1.69|0.577
71731185|NCT00996801|142977086|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.47||||0.078|TWO_SIDED|95.0|-3.07|0.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.12|-3.07|0.078
71731186|NCT00996801|142977087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.99||||0.094|TWO_SIDED|95.0|-4.22|0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.25|-4.22|0.094
71731187|NCT00996801|142977087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.66||||0.157|TWO_SIDED|95.0|-3.82|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.50|-3.82|0.157
71731188|NCT00996801|142977087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.57||||0.157|TWO_SIDED|95.0|-3.53|0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.38|-3.53|0.157
71731189|NCT00996801|142977087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.43||||0.937|TWO_SIDED|95.0|-2.61|1.76||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.76|-2.61|0.937
71731190|NCT00996801|142977087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.1||||0.992|TWO_SIDED|95.0|-2.21|2.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.01|-2.21|0.992
71731191|NCT00996801|142977087|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.01||||0.992|TWO_SIDED|95.0|-1.93|1.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.90|-1.93|0.992
71772072|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71888907|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|-44.97||||0.26|TWO_SIDED|95.0|-141.12|51.17||This is the test of effect modification by CD4 Stage.|t-test, 2 sided||A negative value would reflect a greater treatment effect among those with less than Stage 3 CD4 levels compared to those with Stage 3 CD4.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||51.17|-141.12|0.26
71658774|NCT01355159|142832869|SUPERIORITY||Risk Ratio (RR)|1.2||||0.65|TWO_SIDED|95.0|0.54|2.66|||Chi-squared|||||2.66|0.54|0.65
71731192|NCT00996801|142977088|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.47||||0.824|TWO_SIDED|95.0|-2.5|1.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.56|-2.50|0.824
71731193|NCT00996801|142977088|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.42||||0.824|TWO_SIDED|95.0|-2.28|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-2.28|0.824
71731194|NCT00996801|142977088|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.96||||0.624|TWO_SIDED|95.0|-3.23|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-3.23|0.624
71731195|NCT00996801|142977088|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.78||||0.7|TWO_SIDED|95.0|-1.25|2.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.82|-1.25|0.700
71731196|NCT00996801|142977088|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.83||||0.7|TWO_SIDED|95.0|-1.39|3.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.06|-1.39|0.700
71772073|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772074|NCT00245219|143044368|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772075|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772076|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772077|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772078|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.||||>0.05
71772079|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772080|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772081|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772082|NCT00245219|143044369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.||||>0.05
71772083|NCT01827358|143044373|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|315.2|||<|0.001|TWO_SIDED|97.5|49.6|2698.8|||Fisher Exact|||||2698.8|49.6|<0.001
71772084|NCT01827358|143044374|OTHER|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p\_((1)) (smaller p-value) and p\_((2)) (larger p-value). If p\_((1))=0.025 and p\_((2))=0.05, then the null hypotheses for both tests are rejected. If p\_((1))=0.025 and p\_((2))\>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|39.5|||<|0.001|TWO_SIDED|95.0|5.5|1666.3|||Fisher Exact|||||1666.3|5.5|<0.001
71658775|NCT01355159|142832870|SUPERIORITY||Risk Ratio (RR)|0.34||||0.1|TWO_SIDED|95.0|0.09|1.23|||Chi-squared|||||1.23|0.09|0.10
71658776|NCT01355159|142832871|SUPERIORITY||Risk Ratio (RR)|2.04||||0.33|TWO_SIDED|95.0|0.49|8.57|||Chi-squared|||||8.57|0.49|0.33
71658777|NCT01355159|142832872|SUPERIORITY||Risk Ratio (RR)|0.97||||0.94|TWO_SIDED|95.0|0.47|2.0|||Chi-squared|||||2.00|0.47|0.94
71658778|NCT01355159|142832873|SUPERIORITY||Risk Ratio (RR)|1.61||||0.06|TWO_SIDED|95.0|0.97|2.66|||Chi-squared|||||2.66|0.97|0.06
71658779|NCT01355159|142832874|SUPERIORITY||Risk Ratio (RR)|2.37||||0.21|TWO_SIDED|95.0|0.61|9.14|||Chi-squared|||||9.14|0.61|0.21
71658780|NCT01355159|142832875|SUPERIORITY||Risk Ratio (RR)|1.2||||0.38|TWO_SIDED|95.0|0.8|1.8|||Chi-squared|||||1.80|0.80|0.38
71731197|NCT00996801|142977088|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.3||||0.759|TWO_SIDED|95.0|-1.6|2.19||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.19|-1.60|0.759
71731198|NCT00996801|142977089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.22||||0.227|TWO_SIDED|95.0|-39.15|6.72||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||6.72|-39.15|0.227
71731199|NCT00996801|142977089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.85||||0.853|TWO_SIDED|95.0|-17.9|21.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.61|-17.90|0.853
71731200|NCT00996801|142977089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-13.14||||0.327|TWO_SIDED|95.0|-35.67|9.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.39|-35.67|0.327
71731201|NCT00996801|142977089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-2.74||||0.94|TWO_SIDED|95.0|-23.91|18.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||18.43|-23.91|0.940
71731202|NCT00996801|142977089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|15.33||||0.273|TWO_SIDED|95.0|-7.86|38.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||38.52|-7.86|0.273
71731203|NCT00996801|142977089|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.33||||0.973|TWO_SIDED|95.0|-19.23|19.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||19.90|-19.23|0.973
71731204|NCT00996801|142977090|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.48||||0.01|TWO_SIDED|95.0|-2.66|-0.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.29|-2.66|0.010
71731205|NCT00996801|142977090|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.14||||0.053|TWO_SIDED|95.0|-2.29|0.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.01|-2.29|0.053
71731206|NCT00996801|142977090|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.15||||0.053|TWO_SIDED|95.0|-2.19|-0.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||-0.11|-2.19|0.053
71772085|NCT01827358|143044375|OTHER||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.3|3.28|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||3.28|0.30|0.997
71772086|NCT01827358|143044376|OTHER||Hazard Ratio (HR)|1.33||||0.656|TWO_SIDED|95.0|0.37|4.76|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.||4.76|0.37|0.656
71731207|NCT00996801|142977090|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.58||||0.509|TWO_SIDED|95.0|-1.77|0.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.60|-1.77|0.509
71731208|NCT00996801|142977090|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.25||||0.843|TWO_SIDED|95.0|-1.27|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.27|0.843
71731209|NCT00996801|142977090|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-0.26||||0.843|TWO_SIDED|95.0|-1.43|0.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.92|-1.43|0.843
71772087|NCT01827358|143044378|OTHER||Hazard Ratio (HR)|0.23||||0.182|TWO_SIDED|95.0|0.03|2.01|||Cox proportional hazards models|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.01|0.03|0.182
71658781|NCT01355159|142832876|SUPERIORITY||Mean Difference (Net)|-1.6||||46|TWO_SIDED|95.0|-5.84|2.64|||t-test, 2 sided|||||2.64|-5.84|046
71731210|NCT00996801|142977091|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|86.33|||<|0.001|TWO_SIDED|95.0|64.87|108.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||108.29|64.87|<0.001
71658782|NCT01355159|142832877|SUPERIORITY||Risk Ratio (RR)|0.87||||0.79|TWO_SIDED|95.0|0.31|2.44|||Chi-squared|||||2.44|0.31|0.79
71772088|NCT01827358|143044379|OTHER||Hazard Ratio (HR)|0.24||||0.198|TWO_SIDED|95.0|0.03|2.12|||Cox proportional hazards model|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.||2.12|0.03|0.198
71772089|NCT00510952|143044384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin was 0.4%.|Mean Difference (Net)|-0.05||||0.551||95.0|-0.21|0.11||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin glargine, injected once a day, with regard to glycemic control as measured by change in HbA1c from baseline to 24 week endpoint (last observation carried forward).||0.11|-0.21|0.551
71772090|NCT00510952|143044385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
71772091|NCT00510952|143044385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.09|-0.21|0.427
71772092|NCT00510952|143044385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
71772093|NCT00510952|143044385|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|||0.07|-0.25|0.254
71772094|NCT00510952|143044386|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value for HbA1c \<7.0%.|Fisher Exact|||||||0.634
71772095|NCT00510952|143044386|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for HbA1c ≤6.5%.|Fisher Exact|||||||0.504
71831375|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.14||0.4439|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.17|-0.38|0.4439
71831376|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.9376|TWO_SIDED|95.0|-0.27|0.29|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.27|0.9376
71772096|NCT00510952|143044387|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.8 millimoles per liter (mmol/L).|Mean Difference (Net)|0.06||||0.323||95.0|-0.06|0.19|||ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatment groups (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Insulin lispro protamine suspension is noninferior to glargine at actual morning pre-meal at endpoint.||0.19|-0.06|0.323
71772097|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for Actual Morning Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.302
71772098|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Actual Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.144
71772099|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for Actual Midday Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.279
71731211|NCT00996801|142977091|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|82.14|||<|0.001|TWO_SIDED|95.0|63.0|101.66||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||101.66|63.00|<0.001
71731212|NCT00996801|142977091|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|107.26|||<|0.001|TWO_SIDED|95.0|82.03|133.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||133.23|82.03|<0.001
71731213|NCT00996801|142977091|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.87||||0.104|TWO_SIDED|95.0|-3.8|49.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||49.68|-3.80|0.104
71831377|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.7614|TWO_SIDED|95.0|-0.33|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.24|-0.33|0.7614
71831378|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8081|TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.25|-0.32|0.8081
71831379|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.8078|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.33|-0.25|0.8078
71658783|NCT01355159|142832878|SUPERIORITY||Risk Ratio (RR)|2.0||||0.42|TWO_SIDED|95.0|0.37|10.92|||Chi-squared|||||10.92|0.37|0.42
71658784|NCT04700280|142832880|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|2.69||0.617|TWO_SIDED|90.0|-6.2|3.4|||Mixed Models Analysis|||||3.4|-6.2|0.617
71658785|NCT04700280|142832882|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.62||0.3089|TWO_SIDED|90.0|-1.7|0.41|||Mixed Models Analysis|||Week 4||0.41|-1.70|0.3089
71658786|NCT04700280|142832882|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.71||0.2834|TWO_SIDED|90.0|-1.97|0.43|||Mixed Models Analysis|||Week 8||0.43|-1.97|0.2834
71658787|NCT04700280|142832882|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.95||0.7109|TWO_SIDED|90.0|-2.02|1.3|||Mixed Models Analysis|||Week 12||1.30|-2.02|0.7109
71658788|NCT04700280|142832883|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.81||0.859|TWO_SIDED|90.0|-3.6|2.9|||Mixed Models Analysis|||Week 4||2.9|-3.6|0.859
71658789|NCT04700280|142832883|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.46||0.837|TWO_SIDED|90.0|-3.8|4.8|||Mixed Models Analysis|||Week 8||4.8|-3.8|0.837
71658790|NCT00741936|142832896|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
71658791|NCT00741936|142832897|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
71658792|NCT00741936|142832898|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline||||||<0.05
71658793|NCT00741936|142832899|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.||||||<0.05
71658794|NCT00741936|142832900|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between two treatment groups in each time frame.||||||<0.05
71658795|NCT00741936|142832901|SUPERIORITY_OR_OTHER|||||||0||95.0|||||simple percentage|||||||0
71658796|NCT00741936|142832902|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<0.05
71658797|NCT00741936|142832903|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-samples t-test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71658798|NCT00741936|142832904|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71658799|NCT00741936|142832905|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71658800|NCT00741936|142832906|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71658801|NCT02450526|142832907|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|94.3|||<|0.0001|TWO_SIDED|95.0|90.8|97.7||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||97.7|90.8|<0.0001
71658802|NCT02450526|142832908|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|87.5|||<|0.0001|TWO_SIDED|95.0|82.5|92.4||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||92.4|82.5|<0.0001
71658803|NCT02450526|142832909|NON_INFERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment Difference|-2.4|||||TWO_SIDED|95.0|-6.7|1.9||||||The non-inferiority of Dysport® to Botox on the ILA at maximum frown was tested using a multivariate logistic regression model||1.9|-6.7|
71658804|NCT02450526|142832910|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|73.8|||<|0.0001|TWO_SIDED|95.0|59.1|88.4|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.4|59.1|<0.0001
71658805|NCT02450526|142832911|SUPERIORITY|The comparison between mean scores of SGA at Treatment Cycle 1, Day 29 is based on 2 separate linear mixed models, adjusting on the two stratification parameters, gender and baseline ILA severity score, and the centre.|Treatment Difference|2.603|||<|0.0001|TWO_SIDED|95.0|2.327|2.878||The test was two-sided at the significance level of 0.05|Mixed Models Analysis|||Superiority analysis of Dysport® to placebo was tested using a linear mixed model.||2.878|2.327|<0.0001
71658806|NCT02450526|142832912|SUPERIORITY|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|83.7|||<|0.0001|TWO_SIDED|95.0|78.7|88.7|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.||88.7|78.7|<0.0001
71658807|NCT01150890|142833009|SUPERIORITY|||||||0.1941|||||||Overall Trend test|||The primary null hypothesis was tested sequentially using a linear trend test at the significance level of 0.05 (two-sided) using logistic regression modeling.||||0.1941
71658808|NCT01150890|142833009|SUPERIORITY||Difference in Response Rate|0.0||||1|TWO_SIDED|95.0|-0.09|0.09|||Chi-squared|||||0.09|-0.09|1.0000
71658809|NCT01150890|142833009|SUPERIORITY||Difference in Response Rate|0.1203||||0.0966|TWO_SIDED|95.0|-0.02|0.26|||Chi-squared|||||0.26|-0.02|0.0966
71658810|NCT01150890|142833009|SUPERIORITY||Difference in Response Rate|0.0597||||0.3208|TWO_SIDED|95.0|-0.06|0.17|||Chi-squared|||||0.17|-0.06|0.3208
71658811|NCT01150890|142833010|SUPERIORITY||Difference in Response Rate|0.0363||||0.6831|TWO_SIDED|95.0|-0.14|0.21|||Chi-squared|||||0.21|-0.14|0.6831
71658812|NCT01150890|142833010|SUPERIORITY||Difference in Response Rate|0.1477||||0.1396|TWO_SIDED|95.0|-0.04|0.34|||Chi-squared|||||0.34|-0.04|0.1396
71658813|NCT01150890|142833010|SUPERIORITY||Difference in Response Rate|0.0265||||0.7588|TWO_SIDED|95.0|-0.14|0.19|||Chi-squared|||||0.19|-0.14|0.7588
71731214|NCT00996801|142977091|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|18.68||||0.123|TWO_SIDED|95.0|-5.11|42.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||42.56|-5.11|0.123
71731215|NCT00996801|142977091|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|43.8||||0.003|TWO_SIDED|95.0|12.85|75.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||75.06|12.85|0.003
71731216|NCT00996801|142977092|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|187.31|||<|0.001|TWO_SIDED|95.0|154.44|221.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||221.25|154.44|<0.001
71731217|NCT00996801|142977092|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|200.29|||<|0.001|TWO_SIDED|95.0|161.21|240.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||240.91|161.21|<0.001
71772100|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value for Actual Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.928
71772101|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-value for Actual Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.918
71772102|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value for Actual Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.875
71772103|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Actual 0300 Hours.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.316
71772104|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-value for Daily Mean 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.389
71772105|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Daily Mean Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.836
71772106|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||P-value for Daily Mean Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.394
71772107|NCT00510952|143044388|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Daily Mean Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.||||||0.609
71772108|NCT00510952|143044389|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for All Hypoglycemic Episodes.|Fisher Exact|||||||0.468
71772109|NCT00510952|143044389|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.011
71658814|NCT01150890|142833011|SUPERIORITY|||||||0.4161|||||||ANCOVA|Analysis of covariance (ANCOVA) model adjusted for baseline CDAI score.||||||0.4161
71772110|NCT00510952|143044389|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.036
71772111|NCT00510952|143044390|SUPERIORITY_OR_OTHER|||||||0.316||95.0||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.316
71772112|NCT00510952|143044390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||<0.001
71772113|NCT00510952|143044390|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.||||||0.102
71772114|NCT00510952|143044392|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|-0.01||||0.975||95.0|-0.61|0.59||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: insulin lispro protamine suspension is noninferior to glargine with regard to change in absolute body weight from baseline to endpoint.||0.59|-0.61|0.975
71772115|NCT00510952|143044393|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.031
71772116|NCT00510952|143044394|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.||||||0.015
71772117|NCT03070444|143044432|OTHER|GEE analysis|GEE analysis|0.99||||0.0002|TWO_SIDED|95.0|0.48|1.51|||GEE analysis|||||1.51|0.48|0.0002
71772118|NCT03070444|143044433|OTHER|Mann-Whitney U test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71772119|NCT01373489|143044434|SUPERIORITY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71772120|NCT02582255|143044440|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
71772121|NCT02582255|143044441|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
71772122|NCT02582255|143044442|OTHER|||||||0.025|||||||Clopper-Pearson|||||||0.025
71772123|NCT02582255|143044443|OTHER|||||||0.05|||||||Clopper-Pearson|||||||0.05
71772124|NCT02417844|143044447|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.66|STANDARD_DEVIATION|19.15|||TWO_SIDED|90.0|92.19|107.74|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||107.74|92.19|
71772125|NCT02417844|143044448|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.58|STANDARD_DEVIATION|13.51|||TWO_SIDED|90.0|94.23|105.24|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.24|94.23|
71658815|NCT01150890|142833011|SUPERIORITY|||||||0.8094|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.8094
71658816|NCT01150890|142833011|SUPERIORITY|||||||0.304|||||||ANCOVA|ANCOVA model adjusted for baseline CDAI score.||||||0.3040
71731218|NCT00996801|142977092|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|224.3|||<|0.001|TWO_SIDED|95.0|180.19|270.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||270.39|180.19|<0.001
71731219|NCT00996801|142977092|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|48.29||||0.034|TWO_SIDED|95.0|3.75|93.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||93.11|3.75|0.034
71731220|NCT00996801|142977092|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|61.27||||0.019|TWO_SIDED|95.0|8.8|114.22||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||114.22|8.80|0.019
71731221|NCT00996801|142977092|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|85.28||||0.002|TWO_SIDED|95.0|26.7|144.63||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||144.63|26.70|0.002
71731222|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03|||<|0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|<0.001
71731223|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|133.03||||0.001|TWO_SIDED|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||156.75|110.01|0.001
71731224|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|131.53|||<|0.001|TWO_SIDED|95.0|110.7|152.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||152.94|110.70|<0.001
71731225|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|169.8|||<|0.001|TWO_SIDED|95.0|141.59|199.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||199.11|141.59|<0.001
71831380|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.9705|TWO_SIDED|95.0|-0.28|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.29|-0.28|0.9705
71731226|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|58.57|||<|0.001|TWO_SIDED|95.0|29.42|88.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||88.04|29.42|<0.001
71658817|NCT01822574|142833017|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.001
71658818|NCT01822574|142833018|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||<0.001
71658819|NCT01822574|142833019|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.||||0.240
71731227|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|57.07|||<|0.001|TWO_SIDED|95.0|30.76|83.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||83.64|30.76|<0.001
71731228|NCT00996801|142977093|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|95.34|||<|0.001|TWO_SIDED|95.0|60.4|130.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||130.91|60.40|<0.001
71731229|NCT00996801|142977094|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.86|||<|0.001|TWO_SIDED|95.0|39.31|68.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||68.60|39.31|<0.001
71731230|NCT00996801|142977094|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|53.81|||<|0.001|TWO_SIDED|95.0|41.37|66.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||66.38|41.37|<0.001
71658820|NCT00759902|142833046|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|123.0||||||90.0|112.9|134.1|||ANOVA|log-transformation||||134.1|112.9|
71658821|NCT00759902|142833048|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|98.5|104.9|||ANOVA|log-transformation||||104.9|98.5|
71658822|NCT00759902|142833049|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|102.9||||||90.0|99.3|106.5|||ANOVA|log-transformation||||106.5|99.3|
71731231|NCT00996801|142977094|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|55.47|||<|0.001|TWO_SIDED|95.0|41.19|69.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||69.94|41.19|<0.001
71831381|NCT02528188|143167442|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.5785|TWO_SIDED|95.0|-0.21|0.38|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.||0.38|-0.21|0.5785
71658823|NCT05071313|142833070|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.14||||||A/Victoria||1.14|0.89|
71658824|NCT05071313|142833070|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.28||||||A/Tasmania||1.28|0.97|
71658825|NCT05071313|142833070|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.79|1.05||||||B/Washington||1.05|0.79|
71731232|NCT00996801|142977094|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|20.53||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
71731233|NCT00996801|142977094|SUPERIORITY_OR_OTHER||Difference in Least Mean Squares|20.47||||0.009|TWO_SIDED|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||35.03|5.96|0.009
71731234|NCT00996801|142977094|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|22.13||||0.009|TWO_SIDED|95.0|4.47|39.89||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis|||||39.89|4.47|0.009
71831382|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.74||0.4303|TWO_SIDED|95.0|-0.87|2.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.04|-0.87|0.4303
71731235|NCT03369431|142977109|SUPERIORITY|||||||0.784|||||||t-test, 2 sided|||"Null hypothesis is that there is no difference in the percentage change from baseline in the ATEC Total between Vivomixx and Placebo.~A sample size of 72 participants was needed to determine an effect size of 0.50 with 80% power, with a type 1 error of 5% using a two-sided test. This calculation is based on the assumed effect size of the primary outcome measure, the ATEC. The minimally clinically important difference based on the primary outcome measure with this instrument was 15 points."||||0.784
71731236|NCT03369431|142977110|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Abdominal Pain between Vivomixx and Placebo.||||0.357
71831383|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.75||0.5656|TWO_SIDED|95.0|-1.9|1.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.04|-1.90|0.5656
71658826|NCT05071313|142833070|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after vaccination with fluzone, using a non-inferiority margin of 1.5 for the GMT ratio (Group 2/Group 1).|Geometric Mean Ratio|0.97||||||95.0|0.85|1.1||||||B/Phuket||1.10|0.85|
71658827|NCT03107026|142833085|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.187||0.1187|TWO_SIDED|95.0|-0.66|0.08|||Mixed Models Analysis|||||0.08|-0.66|0.1187
71658828|NCT03107026|142833085|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.192||0.0045|TWO_SIDED|95.0|-0.93|-0.17|||Mixed Models Analysis|||||-0.17|-0.93|0.0045
71658829|NCT03107026|142833086|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.162||0.0256|TWO_SIDED|95.0|-0.68|-0.04|||Mixed Models Analysis|||||-0.04|-0.68|0.0256
71731237|NCT03369431|142977110|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Gaseousness between Vivomixx and Placebo.||||0.290
71731238|NCT03369431|142977110|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Diarrhoea between Vivomixx and Placebo.||||0.418
71658830|NCT03107026|142833086|SUPERIORITY||Median Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.166||0.0025|TWO_SIDED|95.0|-0.83|-0.18|||Mixed Models Analysis|||||-0.18|-0.83|0.0025
71658831|NCT03107026|142833087|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5342|TWO_SIDED|95.0|0.726|1.854|||Regression, Logistic|||||1.854|0.726|0.5342
71658832|NCT03107026|142833087|SUPERIORITY||Odds Ratio (OR)|1.179||||0.4905|TWO_SIDED|95.0|0.738|1.882|||Regression, Logistic|||||1.882|0.738|0.4905
71658833|NCT03107026|142833088|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.946||0.0154|TWO_SIDED|95.0|-4.16|-0.44|||Mixed Models Analysis|||||-0.44|-4.16|0.0154
71831384|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.92||0.976|TWO_SIDED|95.0|-1.78|1.83|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.83|-1.78|0.9760
71731239|NCT03369431|142977110|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Constipation between Vivomixx and Placebo.||||0.734
71731240|NCT03369431|142977110|SUPERIORITY|||||||0.362|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Pain on Stooling between Vivomixx and Placebo.||||0.362
71731241|NCT03369431|142977110|SUPERIORITY|||||||0.705|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in frequency of Difficulty Swallowing between Vivomixx and Placebo.||||0.705
71831385|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.5678|TWO_SIDED|95.0|-1.3|2.36|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.36|-1.30|0.5678
71731242|NCT03369431|142977110|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in change from baseline in frequency of vomiting between Vivomixx and placebo||||0.589
71731243|NCT03369431|142977110|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in stool between Vivomixx and placebo||||1.0
71731244|NCT03369431|142977110|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon signed rank||Null hypothesis is that there is no difference in change from baseline in frequency of blood in vomit between Vivomixx and placebo||||1.0
71831386|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|1.76||0.6974|TWO_SIDED|95.0|-2.77|4.14|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.14|-2.77|0.6974
71731245|NCT03369431|142977111|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline of ABC Irritability score between Vivomixx and Placebo||||0.635
71731246|NCT03369431|142977111|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||The null hypothesis is that there is no difference in the change from baseline of ABC Lethargy/social withdrawal score between Vivomixx and Placebo.||||0.367
71731247|NCT03369431|142977111|SUPERIORITY|||||||0.609|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||Null hypothesis is that there is no difference in the change from baseline in the ABC Stereotypic behaviour between Vivomixx and Placebo.||||0.609
71731248|NCT03369431|142977111|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|Paired samples t-test||Null hypothesis is that there is no difference in the change from baseline of the ABC Hyperactivity/Noncompliance between Vivomixx and Placebo.||||0.805
71731249|NCT03369431|142977111|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank test used.||Null hypothesis is that there is no difference in the change from baseline of the ABC Inappropriate Speech between Vivomixx and Placebo.||||0.985
71731250|NCT03369431|142977112|SUPERIORITY|||||||0.661|||||||Wilcoxon (Mann-Whitney)|Related-samples Wilcoxon Signed Rank||||||0.661
71888908|NCT02939131|143298773|SUPERIORITY||Mean Difference (Final Values)|9.53||||0.72|TWO_SIDED|95.0|-52.97|72.02||This is the test of effect modification by CD4 nadir stage.|t-test, 2 sided||A positive value would reflect a greater treatment effect by those with Stage 3 CD4 Nadir compared to those with less than Stage 3.|An interaction effect is computed based on subgroup differences within sites. The mean subgroup difference is computed for each treatment group and the interaction effect is the difference of those group mean differences. This is equivalent to taking the differences of the treatment effects between subgroups. Note: For the percent of participants with QIDS-SR remission, a positive treatment effect is a positive difference between groups.||72.02|-52.97|0.72
71888909|NCT02939131|143298774|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.26|TWO_SIDED|95.0|-8.4|28.1|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||28.1|-8.4|0.26
71888910|NCT02939131|143298774|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.66|TWO_SIDED|95.0|-37.1|24.6|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with alcohol use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||24.6|-37.1|0.66
71888911|NCT02939131|143298775|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.71|TWO_SIDED|95.0|-22.3|31.7|||t-test, 2 sided||A positive value indicates higher site-level percentages in the COMB-R group.|The percent of participants with regular frequency alcohol use at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||31.7|-22.3|0.71
71888912|NCT02939131|143298775|SUPERIORITY||Mean Difference (Final Values)|26.7||||0.1|TWO_SIDED|95.0|-6.3|59.6|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group.|The percent of participants at each site with regular alcohol use at week 48 was computed. These site-level percents were compared across treatments||59.6|-6.3|0.10
71888913|NCT02939131|143298776|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.09|TWO_SIDED|95.0|-2.6|0.2|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The average number of drinks per day reported at week 24 was computed for each site and these site-level averages were compared across treatments.||0.2|-2.6|0.09
71888914|NCT02939131|143298776|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.79|TWO_SIDED|95.0|-0.8|1.0|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group and vice versa.|The site-level average numbers of drinks per day reported at week 48 were computed and these site-level averages were compared across treatment groups.||1.0|-0.8|0.79
71658834|NCT03107026|142833088|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|0.969||0.0005|TWO_SIDED|95.0|-5.31|-1.5|||Mixed Models Analysis|||||-1.50|-5.31|0.0005
71731251|NCT00046930|142977116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Log Rank|Stratified on age (\< 70 vs. \>=70) and type of leukemia (de novo AML, secondary RAEB-t, or secondary RAEB AML)||The study was designed to have 80% power to detect a non-proportional hazards difference in OS at the one-sided 0.025 significance level of 30.2% vs 39.6%, 12.8% vs 27.1% and 7.0% vs 14.0% at 1 years, 2 years, and full information for zosuquidar and placebo, respectively.||||0.28
71731252|NCT00046930|142977117|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16||95.0|||||Log Rank|Stratified on age and type of leukemia||||||0.16
71772126|NCT02417844|143044449|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.48|STANDARD_DEVIATION|14.12|||TWO_SIDED|90.0|93.9|105.39|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."|||105.39|93.90|
71731253|NCT00046930|142977118|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.617|TWO_SIDED|95.0|0.77|1.65||Test was stratified on age and type of leukemia.|Mantel Haenszel||Zosuquidar/Placebo|Test of difference in the CR (complete remission) rate between the arms.||1.65|0.77|0.617
71772127|NCT01155219|143044453|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71888915|NCT02939131|143298777|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-0.9|0.8|||t-test, 2 sided||A positive value would indicate site level averages were higher in the COMB-R group anc vice versa|The site-level average number of days with binge drinking at week 24 were computed and these site-level averages were compared across treatments.||0.8|-0.9|0.87
71888916|NCT02939131|143298777|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided||A positive difference would indicate site level averages were higher in the COMB-R group and vice versa|The site-level average number of days with binge drinking reported at week 48 were computed and the site-level averages were compared across treatment groups.||0.8|-0.8|0.99
71731254|NCT02317809|142977125|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|114.45|||||TWO_SIDED|90.0|110.87|118.15|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||118.15|110.87|
71731255|NCT02317809|142977126|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|106.99|||||TWO_SIDED|90.0|101.42|112.86|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||112.86|101.42|
71772128|NCT05523323|143044469|OTHER||Estimate difference|29.5||||0.0002014|TWO_SIDED|95.0|14.0|43.9|||Unstratified Miettinen & Nurminen method|One-sided p-value was calculated using the unstratified Miettinen \& Nurminen method.|The exact binomial method by Clopper and Pearson was used to generate the estimate difference and the associated 95% confidence intervals (CIs).|||43.9|14.0|0.0002014
71731256|NCT02317809|142977127|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|112.67|||||TWO_SIDED|90.0|106.44|119.27|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||119.27|106.44|
71731257|NCT02317809|142977128|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|103.27|||||TWO_SIDED|90.0|93.16|114.47|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.||114.47|93.16|
71731258|NCT06504524|142977149|OTHER||Hazard Ratio (HR)|1.128|||=|0.615|TWO_SIDED|95.0|0.705|1.804|||Regression, Cox||IPTW hazard ratio (HR) were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.804|0.705|=0.615
71731259|NCT06504524|142977150|OTHER||Hazard Ratio (HR)|1.18|||=|0.4429|TWO_SIDED|95.0|0.85|1.64|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.64|0.85|=0.4429
71731260|NCT06504524|142977151|OTHER||Hazard Ratio (HR)|0.66|||=|0.12|TWO_SIDED|95.0|0.39|1.115|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.115|0.390|=0.120
71731261|NCT06504524|142977152|OTHER||Hazard Ratio (HR)|0.52|||=|0.0011|TWO_SIDED|95.0|0.38|0.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.71|0.38|=0.0011
71731262|NCT06504524|142977153|OTHER||Hazard Ratio (HR)|0.759|||=|0.503|TWO_SIDED|95.0|0.337|1.71|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.710|0.337|=0.503
71731263|NCT06504524|142977154|OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.26|0.57|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.57|0.26|<0.0001
71731264|NCT06504524|142977155|OTHER||Hazard Ratio (HR)|0.918|||=|0.706|TWO_SIDED|95.0|0.587|1.436|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||1.436|0.587|=0.706
71731265|NCT06504524|142977156|OTHER||Hazard Ratio (HR)|0.68|||=|0.0182|TWO_SIDED|95.0|0.52|0.88|||Regression, Cox||IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.|||0.88|0.52|=0.0182
71731266|NCT03458702|142977178|EQUIVALENCE|It would be expected at baseline that there were no differences between groups.|||||>|0.05|||||||t-test, 2 sided|||||||>.05
71731267|NCT03458702|142977178|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA for TIME||||<0.001
71731268|NCT03458702|142977179|EQUIVALENCE|It would be expected at baseline there would be no difference between groups.|||||>|0.05|||||||ANOVA|||||||>.05
71731269|NCT03458702|142977179|SUPERIORITY||||||<|0.001|||||||ANOVA|||ANOVA: Condition x Time Interaction||||<0.001
71731270|NCT03458702|142977179|SUPERIORITY|||||||0.005|||||||ANOVA|||ANOVA: TIME||||0.005
71731271|NCT03458702|142977180|EQUIVALENCE|It would be hypothesized that there would not be a difference at baseline.|||||>|0.05|||||||ANOVA|||||||> .05
71731272|NCT03458702|142977180|SUPERIORITY|||||||0.042|||||||ANOVA|||ANOVA: CONDITION X TIME INTERACTION||||0.042
71731273|NCT03458702|142977180|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||ANOVA: TIME||||<0.001
71772129|NCT05523323|143044470|OTHER||Hazard Ratio (HR)|0.34||||3.7e-06|TWO_SIDED|95.0|0.21|0.55|||unstratified Log-rank test.|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||0.55|0.21|0.0000037
71731274|NCT03458702|142977181|EQUIVALENCE|A difference at baseline was not expected.|||||>|0.05|||||||ANOVA|||||||>.05
71731275|NCT03458702|142977181|SUPERIORITY|||||||0.016|||||||ANOVA|||ANOVA: TIME||||0.016
71731276|NCT03458702|142977182|EQUIVALENCE|no difference is expected at baseline|||||>|0.05|||||||ANOVA|||||||>.05
71731277|NCT03458702|142977182|SUPERIORITY|||||||0.026|||||||ANOVA|||ANOVA:TIME||||0.026
71731278|NCT03458702|142977183|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<.05
71731279|NCT00168103|142977192|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.525||||0.0025|TWO_SIDED|95.0|-2.217|-0.033||1-sided P-value. The a priori threshold was 0.024 (overall Type 1 error 0.025 adjusted for alpha spending for an interim analysis).|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodges-Lehmann estimate.|||-0.033|-2.217|0.0025
71731280|NCT00168103|142977193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1088||||0.0014|TWO_SIDED|80.0|0.0392|0.3023||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Fisher Exact|1-sided|The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|Worsened intensity was evaluated between 2 and 4 hours after start of study treatment relative to baseline for at least 1 of the HAE symptoms present at baseline.||0.3023|0.0392|0.0014
71731281|NCT00168103|142977194|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.292||||0.0237|TWO_SIDED|80.0|-5.15|-1.05||1-sided, exploratory test.|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodge-Lehmann estimate.|This was an exploratory analysis.||-1.050|-5.150|0.0237
71731282|NCT00168103|142977195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1714|||||TWO_SIDED|95.0|0.0642|0.4575|||||The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|This was an exploratory analysis.||0.4575|0.0642|
71731283|NCT00168103|142977196|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED|80.0||||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Wilcoxon (Mann-Whitney)|1-sided||||||0.0329
71731284|NCT01394614|142977242|SUPERIORITY_OR_OTHER||Incidence-rate difference|0.41|||||TWO_SIDED||||||||Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years|||||
71731285|NCT01394614|142977242|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.32|||||TWO_SIDED|95.0|1.5|11.12|||||Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).|||11.12|1.5|
71731286|NCT01149486|142977243|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.45|||||TWO_SIDED|90.0|80.2|108.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.88|80.20|
71731287|NCT01149486|142977244|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.45|||||TWO_SIDED|90.0|93.15|106.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.18|93.15|
71731288|NCT01149486|142977245|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|93.1|106.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.12|93.10|
71731289|NCT01149486|142977246|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|111.62|||||TWO_SIDED|90.0|101.47|122.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||122.79|101.47|
71731290|NCT01149486|142977247|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||TWO_SIDED|90.0|99.58|112.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.41|99.58|
71731291|NCT01149486|142977248|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.55|||||TWO_SIDED|90.0|99.64|111.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.82|99.64|
71772130|NCT05523323|143044471|OTHER||Hazard Ratio (HR)|0.86||||0.30933|TWO_SIDED|95.0|0.49|1.54|||Unstratified Log-rank test|One-sided p-value was calculated using unstratified Log-rank test.|The unstratified Cox-Regression model with Efron's method of tie handling with treatment as covariate was used to generate Hazard Ratio (HR) and the associated 95%CI.|||1.54|0.49|0.30933
71772131|NCT01948310|143044481|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
71772132|NCT01948310|143044481|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||0-14 weeks||||0.03
71772133|NCT01948310|143044481|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
71772134|NCT01948310|143044481|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||14-0 weeks||||0.005
71772135|NCT01948310|143044482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
71772136|NCT01948310|143044482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
71772137|NCT01948310|143044482|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||2-0 weeks||||0.03
71772138|NCT01948310|143044482|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks||||>0.05
71772139|NCT01948310|143044483|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
71772140|NCT01948310|143044483|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||0-14 weeks||||0.13
71772141|NCT01948310|143044483|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks||||>0.05
71772142|NCT01948310|143044483|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||14-0 weeks||||0.013
71772143|NCT00920829|143044492|SUPERIORITY|||||||0.724|||||||Mixed Models Analysis|||A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.||||0.724
71772144|NCT00920829|143044492|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.||||0.023
71772145|NCT05654441|143044496|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71772146|NCT05654441|143044497|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71772147|NCT05654441|143044498|OTHER|||||||0.007|||||||ANOVA|||||||0.007
71772148|NCT05654441|143044499|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71772149|NCT05654441|143044500|OTHER|||||||0.886|||||||t-test, 2 sided|||||||0.886
71772150|NCT05654441|143044501|OTHER|||||||0.666|||||||t-test, 2 sided|||||||.666
71772151|NCT05654441|143044502|OTHER|||||||0.522|||||||t-test, 2 sided|||||||.522
71731292|NCT01149486|142977249|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.78|||||TWO_SIDED|90.0|98.96|115.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||115.23|98.96|
71888917|NCT02939131|143298778|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.77|TWO_SIDED|95.0|-19.7|26.0|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group and vice versa.|The percent of participants with tobacco use ever at week 24 were computed for each site. These site-level percentages were compared across treatment groups.||26.0|-19.7|0.77
71888918|NCT02939131|143298778|SUPERIORITY||Mean Difference (Final Values)|14.7||||0.2|TWO_SIDED|95.0|-8.9|38.4|||t-test, 2 sided||A positive value would indicate site-level percentages were higher in the COMB-R group.|The percent of participants with tobacco use ever at week 48 were computed for each site. These site-level percentages were compared across treatment groups.||38.4|-8.9|0.20
71888919|NCT02939131|143298779|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.09|TWO_SIDED|95.0|-2.8|33.3|||t-test, 2 sided||A positive difference would indicate the site level percentages were higher in the COMB-R group.|This is the analysis of regular use of tobacco at week 24. The percent of participants at each site with regular use was computed. These site-level percentages were compared across treatment groups.||33.3|-2.8|0.09
71888920|NCT02939131|143298779|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.21|TWO_SIDED|95.0|-14.0|55.3|||t-test, 2 sided||A positive difference indicates site-level percentages were higher in the COMB-R group.|This is the analysis of regular frequency use of tobacco at week 48. Site level percentages of the numbers of participants with regular tobacco use were computed and compared across treatment groups.||55.3|-14.0|0.21
71731293|NCT01149486|142977250|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.37|||||TWO_SIDED|90.0|98.75|106.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.14|98.75|
71772152|NCT05654441|143044503|OTHER|||||||0.438|||||||t-test, 2 sided|||||||.438
71888921|NCT02939131|143298780|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.41|TWO_SIDED|95.0|-12.4|28.3|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||28.3|-12.4|0.41
71888922|NCT02939131|143298780|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.26|TWO_SIDED|95.0|-10.9|36.8|||t-test, 2 sided||A positive value would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||36.8|-10.9|0.26
71888923|NCT02939131|143298780|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.69|TWO_SIDED|95.0|-20.2|29.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 24 were computed and compared across treatment groups.||29.5|-20.2|0.69
71888924|NCT02939131|143298780|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.96|TWO_SIDED|95.0|-24.8|23.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|The site-level percentages of participants ever using any illegal substance excluding marijuana (cannabis) reported at week 48 were computed and compared across treatment groups.||23.5|-24.8|0.96
71772153|NCT05654441|143044504|OTHER|||||||0.181|||||||t-test, 2 sided|||||||.181
71772154|NCT05654441|143044505|OTHER|||||||0.833|||||||t-test, 2 sided|||||||.833
71888925|NCT02939131|143298781|SUPERIORITY||Mean Difference (Final Values)|10.1||||0.53|TWO_SIDED|95.0|-23.9|44.1|||t-test, 2 sided||A positive difference indicates a higher site-level percentage of participants reporting regular use fof marijuana in the COMB-R group compared to the ESC group.|This is the analysis for regular use of marijuana (cannabis) at week 24. The percent of participants at each site reporting regular use (of those reporting any use) was computed. These site-level percentages were averaged and compared across treatments.||44.1|-23.9|0.53
71772155|NCT05654441|143044506|OTHER|||||||0.455|||||||t-test, 2 sided|||||||.455
71772156|NCT03718871|143044551|SUPERIORITY||intracluster correlation coefficient|0.086|||<|0.001|TWO_SIDED|95.0|0.015|0.363||The threshold for significance was set at p \< 0.05.|Fisher Exact|||Given that the intervention arm showed 100% uptake, a multi-level regression model could not be created with a zero in the denominator in the intervention group. We therefore used Fisher's exact test to assess for significant differences in proportion of HIV testing between study arms.||0.363|0.015|<0.001
71772157|NCT03718871|143044552|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71772158|NCT03718871|143044553|SUPERIORITY|||||||0.015|||||||Fisher Exact|||||||0.015
71888926|NCT02939131|143298781|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-35.1|34.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular use of marijuana (cannabis) in the COMB-R group compared to the ESC group.|This is the analysis of regular use of marijuana (cannabis) at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||34.9|-35.1|1.0
71658835|NCT03347422|142833115|SUPERIORITY||Odds Ratio (OR)|15.94|||<|0.001|TWO_SIDED|95.0|2.88|88.04||Threshold for significance was 0.05.|Cochran-Mantel-Haenszel||Stratified by baseline hemoglobin (\< median versus \>=median) and geographic region (Asia/Other, North America, and Europe).|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when primary outcome measure was statistically significant at two-sided 0.05 level.||88.04|2.88|<0.001
71731294|NCT01149486|142977251|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.3|||||TWO_SIDED|90.0|98.72|106.01|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||106.01|98.72|
71658836|NCT03347422|142833117|SUPERIORITY||LS mean difference|2.56|STANDARD_ERROR_OF_MEAN|0.408|<|0.001|TWO_SIDED|95.0|1.75|3.38||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||3.38|1.75|<0.001
71658837|NCT03347422|142833118|SUPERIORITY||LS mean difference|8.93|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|4.0|13.85||Threshold of significance at 0.05 level.|Mixed model for repeated measures|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05 level.||13.85|4.00|<0.001
71658838|NCT00910091|142833139|SUPERIORITY_OR_OTHER|||||||0.1895|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.1895
71658839|NCT00910091|142833140|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0203
71658840|NCT00910091|142833142|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.6980
71658841|NCT00910091|142833143|SUPERIORITY_OR_OTHER|||||||0.3078|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.3078
71658842|NCT00910091|142833144|SUPERIORITY_OR_OTHER|||||||0.0484|TWO_SIDED||||||Kaplan-Meier Analysis|||||||0.0484
71731295|NCT02266875|142977299|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
71658843|NCT01155024|142833145|NON_INFERIORITY_OR_EQUIVALENCE|10 participants required to detect one value change in rating for the SCS scale, with 80% power.|||||>|0.4||95.0||||Two-Sided|t-test, 2 sided|||Alpha level of 0.05||||>0.4
71658844|NCT02633488|142833148|EQUIVALENCE|equivalence defined as less that 2 SD in FMD between 2 treatments|||||>|0.05||||||FMD % change exceeded the threshold of our statistical significance test, i.e. the null hypothesis that there was no effect of metformin remained tenable.|t-test, 2 sided|||||||>0.05
71658845|NCT01175811|142833153|SUPERIORITY_OR_OTHER||LSmean difference|0.01|||||TWO_SIDED|95.0|-0.14|0.16||||||||0.16|-0.14|
71658846|NCT01175811|142833154|SUPERIORITY_OR_OTHER||LSmean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.16||||||||0.16|-0.15|
71658847|NCT01175811|142833155|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.344
71658848|NCT01175811|142833155|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.822
71772159|NCT03718871|143044554|OTHER|No comparison between study arm groups was made in this analysis, as it was limited to control arm only.|Odds Ratio (OR)|1.04|STANDARD_DEVIATION|0.039|<|0.01|TWO_SIDED|95.0|1.02|1.06||Significance threshold two-sided alpha = 0.05|Regression, Linear|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.06|1.02|<0.01
71658849|NCT01175811|142833155|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||P-value is for the comparison of participants achieving \<=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.417
71658850|NCT01175811|142833155|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for the comparison of participants achieving \<=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact|||||||0.392
71658851|NCT01340768|142833164|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.52||||0.028|TWO_SIDED|95.0|0.29|0.94||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.94|0.29|0.028
71658852|NCT01340768|142833165|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.006|TWO_SIDED|95.0|0.29|0.83||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel|||||0.83|0.29|0.006
71658853|NCT01297465|142833169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.947|||TWO_SIDED|95.0|-3.15|0.59|||ANOVA|ANOVA model adjusted for treatment and country|The primary efficacy variable was to be analyzed using an analysis of variance (ANOVA) model, adjusted for treatment and country.|The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®||0.59|-3.15|
71658854|NCT00140426|142833185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.55|TWO_SIDED|95.0|0.41|1.74|||Regression, Cox|Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.|The hazard ratio is for the placebo group versus the treatment group. A hazard ratio \<1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.|||1.74|0.41|0.55
71658855|NCT00140426|142833189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_DEVIATION|3.74||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
71658856|NCT00140426|142833189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.45|STANDARD_DEVIATION|20.88|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71658857|NCT00140426|142833191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.26||0.47|TWO_SIDED|95.0|-0.71|0.33|||t-test, 2 sided||The mean difference was for placebo - risperidone.|Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score||0.33|-0.71|0.47
71658858|NCT00140426|142833192|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
71658859|NCT00140426|142833193|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
71658860|NCT00140426|142833194|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
71658861|NCT00140426|142833195|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
71658862|NCT02149108|142833196|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.49|0.69||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio \<1 favors Nintedanib.|||0.69|0.49|<0.0001
71731296|NCT02266875|142977300|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71772160|NCT03718871|143044555|OTHER|No comparison was made with the intervention arm|Odds Ratio (OR)|0.56||||0.07|TWO_SIDED|95.0|0.3|1.04||Univariate analysis|Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.04|0.30|0.07
71658863|NCT02149108|142833197|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8659|TWO_SIDED|95.0|0.86|1.19||Hazard ratio, confidence interval and p-value obtained from log-rank test stratified by regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio below 1 favors Nintedanib.|||1.19|0.86|0.8659
71658864|NCT02149108|142833199|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|2.0|4.47||Odds ratio and p-value are obtained from logistic regression model adjusted for regorafenib pre-treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.|Regression, Logistic||An odds ratio \>1 indicates benefit to Nintedanib.|||4.47|2.00|<0.0001
71658865|NCT01831765|142833229|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.23|-0.07||||||Change from baseline in HbA1c analysed using a mixed effect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.07|-0.23|
71658866|NCT01831765|142833229|NON_INFERIORITY_OR_EQUIVALENCE|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.04|0.12||||||Change from baseline in HbA1c analysed using a mixedeffect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.12|-0.04|
71658867|NCT00655876|142833237|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.47|TWO_SIDED|95.0|0.7|1.16|||Log Rank|||The sample size was based on the primary hypothesis of a 29% reduction in the hazard rate of death with cetuximab, corresponding to an increase in 2-year overall survival (OS) from 41% to 53% and a hazard ratio (λ\[exp\]/λ\[cont\]) of 0.71 in favor of the cetuximab arm. Assuming an exponential distribution and constant hazards, 400 patients were required to reach 281 OS events, with 80% statistical power, a 1-sided α of 0.025, 4.5 years of accrual, 2 years of follow-up, and 4 interim analyses.||1.16|0.70|0.47
71658868|NCT00655876|142833238|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.66|1.28|||Log Rank|One-sided significance level = 0.025||||1.28|0.66|0.65
71658869|NCT00655876|142833240|SUPERIORITY|||||||0.66|||||||Fisher Exact|One-sided significance level = 0.025||||||0.66
71658870|NCT00655876|142833241|SUPERIORITY|||||||0.04|||||||Chi-squared|Two-sided significance level = 0.05||6-8 weeks post-treatment||||0.04
71731297|NCT02312765|142977342|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71831387|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|2.64|STANDARD_ERROR_OF_MEAN|1.72||0.1261|TWO_SIDED|95.0|-0.75|6.04|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.04|-0.75|0.1261
71658871|NCT00655876|142833241|SUPERIORITY|||||||0.77|||||||Chi-squared|Two-sided significance level = 0.05||1 year||||0.77
71658872|NCT00655876|142833241|SUPERIORITY|||||||0.17|||||||Chi-squared|Two-sided significance level = 0.05||2 years||||0.17
71658873|NCT04561375|142833285|SUPERIORITY||Proportional odds ratio|0.37||||0.067|TWO_SIDED|95.0|0.13|1.07|||proportional odds logistic regression|In the analysis, 100 µg and 150 µg were merged as one level since too few cases used 150 µg.||||1.07|0.13|0.067
71658874|NCT04561375|142833286|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.147|TWO_SIDED|97.5|-5.8|26.0|||Regression, Linear|||||26|-5.8|0.147
71658875|NCT04561375|142833287|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.463|TWO_SIDED|97.5|-18.0|34.0|||Regression, Linear|||||34|-18|0.463
71658876|NCT04561375|142833288|SUPERIORITY||Median Difference (Final Values)|-13.0||||0.032|TWO_SIDED|95.0|-25.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-25|0.032
71731298|NCT02481713|142977349|NON_INFERIORITY|All analyses were two-tailed with alpha set at 0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71731299|NCT02481713|142977350|SUPERIORITY||Risk Ratio (RR)|1.46||||0.0001|TWO_SIDED|95.0|1.25|1.69|||Regression, zero-inflated Poisson|||||1.69|1.25|.0001
71658877|NCT02605993|142833298|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|Mixed Model for Repeated Measures (MMRM)|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 253 for Cohorts 1 to 4, with an estimated standard deviation (SD) of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
71731300|NCT04375397|142977351|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|80.0|-9.2|20.4|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at two-sided alpha = 0.2.||20.4|-9.2|=0.599
71658878|NCT02605993|142833298|OTHER||||||<|0.0001|TWO_SIDED|95.0||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of -40% at Day 281 for Cohort 4 only, with an estimated SD of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.||||<0.0001
71658879|NCT02605993|142833299|OTHER|||||||0.0214||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0214
71658880|NCT02605993|142833299|OTHER|||||||0.0313||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.0313
71658881|NCT02605993|142833300|OTHER|||||||0.0625||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||tatistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0625
71731301|NCT04375397|142977351|SUPERIORITY||Adjusted risk difference (%)|5.8|||=|0.599|TWO_SIDED|95.0|-18.1|28.7|||Miettinen-Nurminen method||Ibrutinib 420 mg + SOC - Placebo + SOC Miettinen-Nurminen (MN) CI for the adjusted risk difference across strata|The difference in response rates between the experimental arm and the control arm were analyzed using the Miettinen-Nurminen (MN) method, adjusting for the stratification factor of prescription for remdesivir. The MN test p-value for testing the rate difference = 0 at twosided alpha = 0.2.||28.7|-18.1|=0.599
71731302|NCT04375397|142977352|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.886|TWO_SIDED|95.0|0.13|10.44|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||10.44|0.13|=0.886
71658882|NCT02605993|142833300|OTHER|MMRM||||||0.5||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.||||0.5000
71658883|NCT02605993|142833301|OTHER|||||||0.4871||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.4871
71658884|NCT02605993|142833301|OTHER|||||||0.4688||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.4688
71658885|NCT02605993|142833302|OTHER|||||||0.0023||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0023
71658886|NCT02605993|142833303|OTHER|||||||0.0029||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.||||0.0029
71658887|NCT02605993|142833303|OTHER|||||||0.125||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.||||0.1250
71658888|NCT02603393|142833305|NON_INFERIORITY|Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) -50 mL.|Mean Difference (Final Values)|-0.026||||0.0404||95.0|-0.053|0.001||1 sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0404
71658889|NCT02603393|142833306|SUPERIORITY||Ratio of rates|1.08||||0.5802||95.0|0.83|1.4||2 sided|Generalized Linear Model Analysis|||||1.40|0.83|0.5802
71658890|NCT02603393|142833307|SUPERIORITY||Ratio of rates|1.08||||0.5651|TWO_SIDED|95.0|0.82|1.43||2-sided|Generalized Linear Model Analysis|||||1.43|0.82|0.5651
71731303|NCT04375397|142977352|SUPERIORITY||Odds Ratio (OR)|0.64|||=|0.705|TWO_SIDED|95.0|0.06|6.43|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -2~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||6.43|0.06|=0.705
71772161|NCT03718871|143044556|OTHER|Comparison between study arms was not performed|Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.16|1.18|||Fisher Exact|||We considered variables that predicted the primary outcome of receiving an HIV test among control arm only, as uptake was 100% in the intervention. First we identified variables that were significant (two-sided p-value\<0.05) in univariate analysis and creating multivariate mixed-effects logistic regression model accounting for covariates and intercorrelation between participants from the same healer by including healers as random effects.||1.18|0.16|0.09
71731304|NCT04375397|142977352|SUPERIORITY||Odds Ratio (OR)|0.0|||=|0.996|TWO_SIDED|95.0|0.0||The upper limit of this 95% CI is infinite.||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = -1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"|||0.00|=0.996
71888927|NCT02939131|143298781|SUPERIORITY||Mean Difference (Final Values)|24.7||||0.18|TWO_SIDED|95.0|-16.2|65.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 24. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||65.5|-16.2|0.18
71888928|NCT02939131|143298781|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.34|TWO_SIDED|95.0|-59.5|22.9|||t-test, 2 sided||A positive difference would indicate higher site-level percentages of regular substance use in the COMB-R group compared to the ESC group.|This is the analysis of regular use of any illegal substance, excluding cannabis, at week 48. Of those reporting ever used, the percent at each site reporting regular use was computed. These site-level percentages were averaged and compared across treatment groups.||22.9|-59.5|0.34
71888929|NCT02939131|143298782|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.29|TWO_SIDED|95.0|-12.9|39.6|||t-test, 2 sided||A positive value would indicate higher site-level percents in the COMB-R group.|This is the analysis for week 24. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||39.6|-12.9|0.29
71888930|NCT02939131|143298782|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.7|TWO_SIDED|95.0|-17.0|24.5|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group|This is the analysis for week 48. The percentage of participants at a site who reported using sex as a commodity was calculated and the site-level percentages were averaged and compared across treatments.||24.5|-17.0|0.70
71888931|NCT02939131|143298783|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.71|TWO_SIDED|95.0|-13.7|19.4|||t-test, 2 sided||A positive difference indicates the site-level averages were higher for the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.4|-13.7|0.71
71888932|NCT02939131|143298783|SUPERIORITY||Mean Difference (Final Values)|-4.7||||0.44|TWO_SIDED|95.0|-17.5|8.1|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||8.1|-17.5|0.44
71888933|NCT02939131|143298784|SUPERIORITY||Mean Difference (Final Values)|7.3||||0.23|TWO_SIDED|95.0|-5.3|19.8|||t-test, 2 sided||A positive value would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 24. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||19.8|-5.3|0.23
71731305|NCT04375397|142977352|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 0~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
71772162|NCT00054717|143044587|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71888934|NCT02939131|143298784|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.73|TWO_SIDED|95.0|-17.5|12.7|||t-test, 2 sided||A positive difference would indicate site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Scores were averaged by site and the site-level averages were averaged and compared across treatment groups.||12.7|-17.5|0.73
71772163|NCT00054717|143044588|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71772164|NCT00054717|143044589|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71888935|NCT02939131|143298785|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.24|TWO_SIDED|95.0|-0.4|1.5|||t-test, 2 sided||A positive value would indicate site-level averages were higher in COMB-R group.|This is the analysis for week 24. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.5|-0.4|0.24
71658891|NCT02603393|142833308|SUPERIORITY||Ratio of rates|1.02||||0.9665|TWO_SIDED|95.0|0.44|2.34||2-sided|Generalized Linear Model Analysis|||||2.34|0.44|0.9665
71731306|NCT04375397|142977352|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 1~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
71772165|NCT00054717|143044590|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772166|NCT00054717|143044591|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772167|NCT00054717|143044592|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772168|NCT00054717|143044593|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772169|NCT00054717|143044594|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772170|NCT00054717|143044595|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772171|NCT00054717|143044596|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772172|NCT00054717|143044597|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772173|NCT00054717|143044598|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71731307|NCT04375397|142977352|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.969|TWO_SIDED|95.0|0.04|32.18|||Multinomial Logistic Regression|||"Change in ordinal score from baseline to day 14 = 3~To evaluate the odds of clinical status improvement as determined by the WHO-8 ordinal scale, a multinomial logistic regression model was used.~Pairwise Comparison in Reference to the Group with Change = -4"||32.18|0.04|=0.969
71731308|NCT04375397|142977353|SUPERIORITY||Difference in Medians|-1.5|||=|0.801|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on supplemental oxygen was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.801
71731309|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
71731310|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 7-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
71731311|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|80.0|-6.7|7.3|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||7.3|-6.7|=1.000
71731312|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|0.0|||=|1|TWO_SIDED|95.0|-14.4|15.5|||Miettinen-Nurminen|||"At Day 14-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||15.5|-14.4|=1.000
71731313|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
71731314|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 21-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
71731315|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|80.0|-1.7|14.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||14.8|-1.7|=0.267
71731316|NCT04375397|142977354|SUPERIORITY||Mortality rate difference|4.8|||=|0.267|TWO_SIDED|95.0|-9.6|22.8|||Miettinen-Nurminen|||"At Day 28-- Ibrutinib 420 mg + SOC - Placebo + SOC~The Miettinen-Nurminen (MN) test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2 and associated confidence intervals are reported."||22.8|-9.6|=0.267
71731317|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
71731318|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 7~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
71731319|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|80.0|-24.8|3.3|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||3.3|-24.8|=0.314
71772174|NCT00054717|143044599|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772175|NCT00054717|143044600|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772176|NCT00054717|143044601|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772177|NCT00054717|143044602|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772178|NCT00054717|143044603|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||||0.0001
71772179|NCT00054717|143044604|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71658892|NCT02603393|142833309|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.0573||95.0|-0.053|0.001||2-Sided|Mixed Model for Repeated Measures Analys|||||0.001|-0.053|0.0573
71658893|NCT02603393|142833310|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.0022||95.0|0.7|3.0||2-Sided|Mixed Model for Repeated Measures Analys|||||3.0|0.7|0.0022
71658894|NCT02603393|142833311|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.0221|TWO_SIDED|95.0|0.2|2.6||2-Sided|Mixed Model for Repeated measures Analys|||||2.6|0.2|0.0221
71658895|NCT02603393|142833312|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.1724||95.0|-0.587|0.105|||Mixed Model for Repeated Measures Analys|||||0.105|-0.587|0.1724
71658896|NCT02603393|142833313|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.1055||95.0|-0.638|0.061||2-Sided|Mixed Model for Repated Measures Analysi|||||0.061|-0.638|0.1055
71888936|NCT02939131|143298785|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.22|TWO_SIDED|95.0|-0.3|1.0|||t-test, 2 sided||A positive difference indicates site-level averages were higher in the COMB-R group.|This is the analysis for week 48. Numbers of partners were averaged by site and the site-level averages were averaged and compared across treatment groups.||1.0|-0.3|0.22
71658897|NCT02603393|142833314|SUPERIORITY||Mean Difference (Final Values)|0.177||||0.0641||95.0|-0.01|0.365||2-Sided|Linear Mixed Model Analysis|||||0.365|-0.010|0.0641
71658898|NCT02603393|142833315|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.4107|TWO_SIDED|95.0|-0.025|0.061||2-Sided|Mixed Model for Repeated Measures Analys|||||0.061|-0.025|0.4107
71658899|NCT00759187|142833325|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors)|ANOVA|||||||<0.05
71658900|NCT00296231|142833326|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||Paired Student's t-test was used to compare pre and post intervention pCO2 values.||||0.011
71658901|NCT01986010|142833349|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.8|2.6||||||GMT Ratio: GMT V160/GMT placebo||2.6|0.8|
71658902|NCT01986010|142833349|OTHER||GMT Ratio|1.9|||||TWO_SIDED|95.0|1.1|3.2||||||GMT Ratio: GMT V160/GMT placebo||3.2|1.1|
71658903|NCT01986010|142833349|OTHER||GMT Ratio|3.5|||||TWO_SIDED|95.0|1.6|7.4||||||GMT Ratio: GMT V160/GMT placebo||7.4|1.6|
71658904|NCT01986010|142833349|OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.4|4.6||||||GMT Ratio: GMT V160/GMT placebo||4.6|1.4|
71658905|NCT01986010|142833349|OTHER||GMT Ratio|1.6|||||TWO_SIDED|95.0|0.9|3.0||||||GMT Ratio: GMT V160/GMT placebo||3.0|0.9|
71658906|NCT01986010|142833349|OTHER||GMT Ratio|3.9|||||TWO_SIDED|95.0|2.2|7.0||||||GMT Ratio: GMT V160/GMT placebo||7.0|2.2|
71658907|NCT01986010|142833349|OTHER||GMT Ratio|16.4|||<|0.001|TWO_SIDED|95.0|9.5|28.4||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||28.4|9.5|<0.001
71658908|NCT01986010|142833349|OTHER||GMT Ratio|76.6|||<|0.001|TWO_SIDED|95.0|49.5|118.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||118.6|49.5|<0.001
71658909|NCT01986010|142833349|OTHER||GMT Ratio|68.1|||<|0.001|TWO_SIDED|95.0|40.1|115.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||115.6|40.1|<0.001
71658910|NCT01986010|142833349|OTHER||GMT Ratio|41.0|||<|0.001|TWO_SIDED|95.0|23.8|70.7||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||70.7|23.8|<0.001
71658911|NCT01986010|142833349|OTHER||GMT Ratio|128.6|||<|0.001|TWO_SIDED|95.0|87.0|190.3||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||190.3|87.0|<0.001
71658912|NCT01986010|142833349|OTHER||GMT Ratio|62.0|||<|0.001|TWO_SIDED|95.0|30.5|126.1||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||126.1|30.5|<0.001
71658913|NCT01986010|142833349|OTHER||GMT Ratio|63.0|||<|0.001|TWO_SIDED|95.0|31.9|124.6||Hypothesis is GMT Ratio \>1|Two sample t-test|||GMT Ratio: GMT V160/GMT placebo||124.6|31.9|<0.001
71661191|NCT00945100|142835953|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.||||0.50
71772180|NCT00054717|143044605|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71772181|NCT00054717|143044606|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71772182|NCT00054717|143044646|SUPERIORITY_OR_OTHER|||||||0.9894||95.0|||||Log Rank|||||||0.9894
71772183|NCT04626310|143044733|SUPERIORITY||Linear slope difference DBT-ER-IP|0.096|STANDARD_ERROR_OF_MEAN|0.08||0.8|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.8
71772184|NCT04626310|143044733|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.234|STANDARD_ERROR_OF_MEAN|0.385||0.544|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.544
71772185|NCT04626310|143044733|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|0.329|STANDARD_ERROR_OF_MEAN|0.429||0.442|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.442
71772186|NCT04626310|143044734|SUPERIORITY||Linear slope difference DBT-ER-IP|1.951|STANDARD_ERROR_OF_MEAN|1.15||0.09|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.09
71772187|NCT04626310|143044734|SUPERIORITY||Linear slope difference DBT-IE-IP|0.1|STANDARD_ERROR_OF_MEAN|1.228||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
71772188|NCT04626310|143044734|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|1.851|STANDARD_ERROR_OF_MEAN|1.103||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Linear Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
71772189|NCT04626310|143044734|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
71731320|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-10.7|||=|0.314|TWO_SIDED|95.0|-32.8|12.0|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 14~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||12.0|-32.8|=0.314
71888937|NCT02939131|143298786|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.57|TWO_SIDED|95.0|-40.4|23.9|||t-test, 2 sided||A positive value would indicate higher site-level percents of low frequency condom use in COMB-R treatment group and vice versa.|This is the analysis for week 24 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||23.9|-40.4|0.57
71888938|NCT02939131|143298786|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.15|TWO_SIDED|95.0|-53.1|9.5|||t-test, 2 sided||A positive difference would indicate higher site-level percentages in the COMB-R group and vice versa.|This is the analysis for week 48 data. We computed the percent of participants reporting low frequency of condom use in past three months by site, averaged the site-level percents and compared these averages across treatment arms.||9.5|-53.1|0.15
71888939|NCT02939131|143298787|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.65|TWO_SIDED|95.0|-40.9|27.2|||t-test, 2 sided||A positive difference would indicate site level percents were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 24, then averaged the site-level percentages by treatment group and compared these group average percents.||27.2|-40.9|0.65
71731321|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
71731322|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 21~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
71731323|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|80.0|-20.4|9.2|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||9.2|-20.4|=0.599
71731324|NCT04375397|142977355|SUPERIORITY||Adjusted risk difference (%)|-5.8|||=|0.599|TWO_SIDED|95.0|-28.7|18.1|||Miettinen-Nurminen|||"Failure/Mortality Rate Difference Compared to Placebo + SOC at Day 28~The difference in response rates between the experimental arm and the control arm was analyzed using the Miettinen-Nurminen (MN) method adjusting for the stratification factor of prescription for remdesivir. MN test p-value for testing the rate difference = 0 adjusting for the stratification factor of prescription for remdesivir using Cochran-Mantel-Haenszel weights at two-sided alpha of 0.2."||18.1|-28.7|=0.599
71731325|NCT04375397|142977356|SUPERIORITY||||||=|0.851|||||||Log Rank|||For the analysis of mechanical ventilation-free survival, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.851
71772190|NCT04626310|143044734|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
71772191|NCT04626310|143044734|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
71772192|NCT04626310|143044735|SUPERIORITY||Linear slope difference DBT-ER-IP|0.059|STANDARD_ERROR_OF_MEAN|0.083||0.475|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.475
71772193|NCT04626310|143044735|SUPERIORITY||Linear slope difference DBT-IE-IP|0.037|STANDARD_ERROR_OF_MEAN|0.082||0.654|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.654
71772194|NCT04626310|143044735|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|0.022|STANDARD_ERROR_OF_MEAN|0.085||0.791|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The slopes of the difference between neutral and negative-maintain were regressed on time (weeks, centered around the start of treatment) and calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.791
71772195|NCT04626310|143044736|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.332|STANDARD_ERROR_OF_MEAN|0.095||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.001
71731326|NCT04375397|142977357|SUPERIORITY||Difference in Medians|0.0|||=|0.745|TWO_SIDED||||||Van Elteren's test||Ibrutinib 420 mg + SOC - Placebo + SOC|Median days spent on mechanical ventilation were compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.745
71731327|NCT04375397|142977358|SUPERIORITY||Difference in Medians|-0.5|||=|0.977|TWO_SIDED||||||Van Elteren's test]||Ibrutinib 420 mg + SOC - Placebo + SOC|Median duration of hospitalization was compared between treatment groups using Van Elteren's test with the stratification factor of prescription for remdesivir.||||=0.977
71731328|NCT04375397|142977359|SUPERIORITY||||||=|0.969|||||||Log Rank|||For the analysis of time to discharge from hospital, the distribution of time to event was estimated by treatment group using Kaplan-Meier methodology and compared between the experimental arm and the control arm using the log-rank test stratified by prescription for remdesivir.||||=0.969
71888940|NCT02939131|143298787|SUPERIORITY||Mean Difference (Final Values)|-37.8||||0.02|TWO_SIDED|95.0|-69.7|-5.8|||t-test, 2 sided||A positive difference would indicate site-level percentages were higher in the COMB-R group and vice versa.|We computed the site-level percentages of participants reporting low frequency condom use at week 48, then averaged the site-level percentages by treatment group and compared these group average percents.||-5.8|-69.7|0.02
71731329|NCT00610441|142977381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6996||||0.0147|TWO_SIDED|97.5|-10.911|-0.4881||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|Mixed Model for Repeated Measurements||Mixed Model for Repeated Measurements (MMRM) with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||-0.4881|-10.911|0.0147
71731330|NCT00610441|142977381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9926||||0.591|TWO_SIDED|97.5|-3.2961|5.2814||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.2814|-3.2961|0.5910
71731331|NCT00610441|142977382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.8506|||||TWO_SIDED|95.0|1.799|26.0878|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||26.0878|1.7990|
71731332|NCT00610441|142977382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9461|||||TWO_SIDED|95.0|0.3119|2.8701|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||2.8701|0.3119|
71731333|NCT00610441|142977383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2468|||||TWO_SIDED|95.0|0.6712|58.1395|||||Since no participants in the Placebo group achieved a 50% reduction, the comparison was done using a Cochran-Mantel-Haenszel method and 0.5 was added to both groups.|||58.1395|0.6712|
71731334|NCT00610441|142977383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1453|||||TWO_SIDED|95.0|0.0152|1.388|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.|||1.3880|0.0152|
71731335|NCT00610441|142977386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2074|||||TWO_SIDED|95.0|0.5654|2.5785|||||Proportional odds model with fixed effects for treatment and period.|||2.5785|0.5654|
71731336|NCT00610441|142977386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8548|||||TWO_SIDED|95.0|0.6951|4.9494|||||Proportional odds model with fixed effects for treatment and period.|||4.9494|0.6951|
71731337|NCT00610441|142977387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3149|||||TWO_SIDED|95.0|0.5402|3.2008|||||Proportional odds model with fixed effects for treatment and period.|||3.2008|0.5402|
71731338|NCT00610441|142977387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3982|||||TWO_SIDED|95.0|0.524|3.7309|||||Proportional odds model with fixed effects for treatment and period.|||3.7309|0.5240|
71731339|NCT00610441|142977388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3163||||0.6155|TWO_SIDED|97.5|-1.8138|1.1812||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1812|-1.8138|0.6155
71731340|NCT00610441|142977388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2934||||0.133|TWO_SIDED|97.5|-0.7449|3.3317||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||3.3317|-0.7449|0.1330
71772196|NCT04626310|143044736|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.165|STANDARD_ERROR_OF_MEAN|0.094||0.078|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.078
71888941|NCT02939131|143298788|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.33|TWO_SIDED|95.0|-3.0|8.1|||t-test, 2 sided||A positive difference indicates COMB-R participants attended more sessions than ESC|We averaged the number of counseling sessions for each site and compared these site-level averages.||8.1|-3.0|0.33
71731341|NCT00610441|142977389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5501||||0.3907|TWO_SIDED|97.5|-0.9427|2.0429||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||2.0429|-0.9427|0.3907
71658914|NCT03276221|142833399|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.215
71658915|NCT03276221|142833400|SUPERIORITY||Slope|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.495|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the paired associates learning module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of picking the correct box for the abstinence group above and beyond the monitoring group (positive values indicate better memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.495
71658916|NCT03276221|142833401|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.050
71658917|NCT03276221|142833402|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.12||0.532|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial span module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of reaching a longer span for the abstinence group above and beyond the monitoring group (positive values indicate higher span lengths for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.532
71661192|NCT00945100|142835955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.04|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||||1.0|0.04|
71731342|NCT00610441|142977389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0065||||0.9872|TWO_SIDED|97.5|-0.9486|0.9357||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||0.9357|-0.9486|0.9872
71731343|NCT00610441|142977390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1543||||0.7828|TWO_SIDED|97.5|-1.4898|1.1811||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.1811|-1.4898|0.7828
71731344|NCT00610441|142977390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4222||||0.2883|TWO_SIDED|97.5|-0.5187|1.363||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||1.3630|-0.5187|0.2883
71772197|NCT04626310|143044736|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.167|STANDARD_ERROR_OF_MEAN|0.095||0.08|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. We examined the effect of Negative Decrease vs. Negative Maintain over time per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.080
71772198|NCT04626310|143044737|SUPERIORITY||Linear Slope Diff DBT-ER-IP|0.091|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.13
71772199|NCT04626310|143044737|SUPERIORITY||Linear slope difference DBT-IE-IP|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.046|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.046
71731345|NCT00610441|142977391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9685||||0.6532|TWO_SIDED|97.5|-5.9599|4.0229|||MMRM|To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||4.0229|-5.9599|0.6532
71731346|NCT00610441|142977391|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1022||||0.5247|TWO_SIDED|97.5|-2.8951|5.0996||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).||5.0996|-2.8951|0.5247
71731347|NCT01173029|142977403|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|1.7||||0.19|TWO_SIDED|95.0|0.7|4.1||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' tests Yates's corrected Chi-squared or Fisher's exact test, when appropriate Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||4.1|0.7|0.19
71731348|NCT01173029|142977404|NON_INFERIORITY_OR_EQUIVALENCE|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|2.6||||0.01|TWO_SIDED|95.0|1.01|7.3||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' test Yates' corrected Chi-squared or Fisher's exact test Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"||7.3|1.01|0.01
71731349|NCT01173029|142977404|NON_INFERIORITY_OR_EQUIVALENCE|Proportional-risk hypothesis was tested using the correlation between Schoenfeld's residuals and time (Schoenfeld's global test). The correlation rho was -0.08, Chi-squared was 0.12, and p was 0.73. Therefore, the hypothesis of proportional risk was accepted, validating the correct application model.|Hazard Ratio (HR)|2.2||||0.04|TWO_SIDED|95.0|1.1|4.8||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic groups|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for both groups.||Cox proportional hazard model for the composite endpoint (stroke + myocardial infarction) was assessed. By taking pseudo-resistant arterial hypertension as baseline reference, the hazard ratio for the composite endpoint was calculated.||4.8|1.1|0.04
71731350|NCT01173029|142977405|SUPERIORITY_OR_OTHER||C-statistic|0.66|||<|0.01|TWO_SIDED|95.0|0.56|0.76||At an optimal value of \>3, polygenic risk score yielded 90% sensitivity and 40% specificity for composite endpoint.|z test|Area under receiver operating characteristic curve.|The optimal cutoff value for polygenic risk score was set to \>3.|Receiver operating characteristic curve analysis for the polygenic score as predictor of composite endpoint (stroke + myocardial infarction)||0.76|0.56|<0.01
71731351|NCT01173029|142977405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.9||||0.04|TWO_SIDED|95.0|1.2|9.2||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic group|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for polygenic risk score\<=3 and \>3.||Cox proportional hazard model of the polygenic risk score\<=3 and \> 3 for the composite endpoint (stroke + myocardial infarction). By taking polygenic risk score\<=3, the hazard ratio for the composite endpoint was calculated for polygenic risk score\>3 .||9.2|1.2|0.04
71731352|NCT00554099|142977408|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-3.0|STANDARD_ERROR_OF_MEAN|1.69||0.3781|ONE_SIDED|90.0||-0.809|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||-0.809||0.3781
71772200|NCT04626310|143044737|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.028|STANDARD_ERROR_OF_MEAN|0.057||0.617|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. The Negative x Novel x time (weeks, centered around the start of treatment) slopes were calculated per condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.617
71772201|NCT04626310|143044738|SUPERIORITY||Linear slope difference DBT-ER-IP|-0.29|STANDARD_ERROR_OF_MEAN|0.103||0.005|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.005
71772202|NCT04626310|143044738|SUPERIORITY||Linear slope difference DBT-IE-IP|-0.111|STANDARD_ERROR_OF_MEAN|0.103||0.281|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.281
71772203|NCT04626310|143044738|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|-0.18|STANDARD_ERROR_OF_MEAN|0.098||0.066|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of change in this interaction effect were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.066
71772204|NCT04626310|143044739|SUPERIORITY||Linear slope difference DBT-ER-IP|1.049|STANDARD_ERROR_OF_MEAN|0.653||0.108|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.108
71731353|NCT00554099|142977408|SUPERIORITY_OR_OTHER||Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|1.74||0.6285|ONE_SIDED|90.0||0.815|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||0.815||0.6285
71731354|NCT00554099|142977408|SUPERIORITY_OR_OTHER||Mean Difference vs. Asacol|1.6|STANDARD_ERROR_OF_MEAN|1.58||0.4365|ONE_SIDED|90.0||3.573|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.||3.573||0.4365
71731355|NCT00554099|142977409|SUPERIORITY_OR_OTHER||Difference vs. Placebo|21.1|STANDARD_ERROR_OF_MEAN|12.53||0.0576|ONE_SIDED|90.0|5.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||5.1|0.0576
71731356|NCT00554099|142977409|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.8|STANDARD_ERROR_OF_MEAN|13.27||0.3248|ONE_SIDED|90.0|-10.2||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-10.2|0.3248
71731357|NCT00554099|142977409|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-14.4|STANDARD_ERROR_OF_MEAN|12.87||0.8596|ONE_SIDED|90.0|-30.8||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-30.8|0.8596
71731358|NCT00554099|142977410|SUPERIORITY_OR_OTHER||Difference vs. Placebo|16.7|STANDARD_ERROR_OF_MEAN|14.0||0.1266|ONE_SIDED|90.0|-1.3||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-1.3|0.1266
71731359|NCT00554099|142977410|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-20.8|STANDARD_ERROR_OF_MEAN|14.13||0.9288|ONE_SIDED|90.0|-38.9||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-38.9|0.9288
71731360|NCT00554099|142977410|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-37.5|STANDARD_ERROR_OF_MEAN|12.98||0.9962|ONE_SIDED|90.0|-54.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||||-54.1|0.9962
71731361|NCT00554099|142977411|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-1.4|STANDARD_ERROR_OF_MEAN|2.784||0.3082|ONE_SIDED|90.0||2.196|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||2.196||0.3082
71831388|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.78||0.406|TWO_SIDED|95.0|-4.96|2.01|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.01|-4.96|0.4060
71731362|NCT00554099|142977411|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.083|STANDARD_ERROR_OF_MEAN|2.903||0.5113|ONE_SIDED|90.0||3.832|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.832||0.5113
71831389|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|1.78||0.848|TWO_SIDED|95.0|-3.84|3.15|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.15|-3.84|0.8480
71831390|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|1.94||0.923|TWO_SIDED|95.0|-4.0|3.63|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.63|-4.00|0.9230
71731363|NCT00554099|142977411|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.483|STANDARD_ERROR_OF_MEAN|2.836||0.6988|ONE_SIDED|90.0||5.145|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.145||0.6988
71731364|NCT00554099|142977412|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|-0.428|STANDARD_ERROR_OF_MEAN|3.067||0.4448|ONE_SIDED|90.0||3.541|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||3.541||0.4448
71731365|NCT00554099|142977412|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Placebo|0.825|STANDARD_ERROR_OF_MEAN|3.151||0.6029|ONE_SIDED|90.0||4.903|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||4.903||0.6029
71731366|NCT00554099|142977412|SUPERIORITY_OR_OTHER||LS Mean Difference vs. Mesalamine|1.253|STANDARD_ERROR_OF_MEAN|2.996||0.6615|ONE_SIDED|90.0||5.129|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.||||5.129||0.6615
71731367|NCT00554099|142977413|SUPERIORITY_OR_OTHER||Difference vs. Placebo|2.6|STANDARD_ERROR_OF_MEAN|4.2||0.7165|ONE_SIDED|90.0||7.9|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||7.9||0.7165
71731368|NCT00554099|142977413|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.4|STANDARD_ERROR_OF_MEAN|2.41||0.1708|ONE_SIDED|90.0||0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||0.6||0.1708
71731369|NCT00554099|142977413|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-5.0|STANDARD_ERROR_OF_MEAN|3.45||0.1039|ONE_SIDED|90.0||-0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||-0.6||0.1039
71731370|NCT00554099|142977414|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-7.5|STANDARD_ERROR_OF_MEAN|8.21||0.1907|ONE_SIDED|90.0||3.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||3.0||0.1907
71731371|NCT00554099|142977414|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-8.2|STANDARD_ERROR_OF_MEAN|8.4||0.173|ONE_SIDED|90.0||2.5|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||2.5||0.1730
71731372|NCT00554099|142977414|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|-0.7|STANDARD_ERROR_OF_MEAN|7.61||0.4613|ONE_SIDED|90.0||9.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||9.0||0.4613
71731373|NCT00554099|142977415|SUPERIORITY_OR_OTHER||Difference vs. Placebo|-2.9|STANDARD_ERROR_OF_MEAN|11.7||0.3983|ONE_SIDED|90.0||12.1|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||12.1||0.3983
71772205|NCT04626310|143044739|SUPERIORITY||Linear slope difference DBT-IE-IP|-1.21|STANDARD_ERROR_OF_MEAN|0.454||0.014|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.014
71831391|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|1.96||0.4421|TWO_SIDED|95.0|-5.36|2.34|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.34|-5.36|0.4421
71888942|NCT02939131|143298793|SUPERIORITY||Mean Difference (Final Values)|18.7||||0.06|TWO_SIDED|95.0|-0.9|38.2|||t-test, 2 sided||A positive difference indicates more participants in the COMB-R group were taking medications, based on site-level percentages.|This is the analysis for the percent of participants on any psychiatric medication at week 24. Site-level percentages were compared across treatments.||38.2|-0.9|0.06
71888943|NCT02939131|143298793|SUPERIORITY||Mean Difference (Final Values)|17.4||||0.06|TWO_SIDED|95.0|-0.7|35.5|||t-test, 2 sided||A positive difference means the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on antidepressant medications. Site-level percentages were compared across treatments.||35.5|-0.7|0.06
71888944|NCT02939131|143298793|SUPERIORITY||Mean Difference (Final Values)|22.4||||0.02|TWO_SIDED|95.0|4.2|40.6|||t-test, 2 sided||A positive difference indicates the site-level percentages of those taking medications were higher in the COMB-R group.|This is the analysis of the percent of participants on SSRI antidepressant medications. Site-level percentages were compared across treatments.||40.6|4.2|0.02
71888945|NCT02939131|143298793|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.54|TWO_SIDED|95.0|-17.3|9.6|||t-test, 2 sided||A positive difference would indicate site-level percentages of those on medication were higher in the COMB-R group.|This is the analysis of the percent of participants on non-SSRI antidepressant medications. Site-level percentages were compared across treatments.||9.6|-17.3|0.54
71731374|NCT00554099|142977415|SUPERIORITY_OR_OTHER||Difference vs. Placebo|6.0|STANDARD_ERROR_OF_MEAN|12.66||0.6721|ONE_SIDED|90.0||22.2|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||22.2||0.6721
71772206|NCT04626310|143044739|SUPERIORITY||Linear slope difference DBT-ER-DBT-IE|2.17|STANDARD_ERROR_OF_MEAN|0.631||0.001|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. neutral images on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.001
71772207|NCT04626310|143044740|OTHER||Linear Slope difference DBT-ER-IP|0.17|STANDARD_ERROR_OF_MEAN|0.136||0.211|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.211
71772208|NCT04626310|143044740|SUPERIORITY||Linear Slope difference DBT-IE-IP|-0.195|STANDARD_ERROR_OF_MEAN|0.135||0.148|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.148
71772209|NCT04626310|143044740|SUPERIORITY||Linear Slope difference DBT-ER-DBT-IE|-0.025|STANDARD_ERROR_OF_MEAN|0.137||0.857|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of the effect of negative maintain vs. negative decrease on weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.857
71772210|NCT04626310|143044741|SUPERIORITY||Linear Slope Difference in DSS DBT-ER-IP|-0.313|STANDARD_ERROR_OF_MEAN|0.794||0.693|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.693
71772211|NCT04626310|143044741|SUPERIORITY||Linear Slope Difference in DSS DBT-IE-IP|0.002|STANDARD_ERROR_OF_MEAN|0.767||0.998|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.998
71731375|NCT00554099|142977415|SUPERIORITY_OR_OTHER||Difference vs. Mesalamine|8.9|STANDARD_ERROR_OF_MEAN|12.23||0.7703|ONE_SIDED|90.0||24.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.||||24.6||0.7703
71772212|NCT04626310|143044741|SUPERIORITY||Linear Slope Diff in DSS DBT-ER-DBT-IE|-0.315|STANDARD_ERROR_OF_MEAN|0.765||0.68|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DSS over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to DBT-IE.||||.680
71772213|NCT04626310|143044741|SUPERIORITY||Linear Slope Difference in DC1 DBT-ER-IP|0.098|STANDARD_ERROR_OF_MEAN|0.101||0.333|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-ER to IP.||||.333
71772214|NCT04626310|143044741|SUPERIORITY||Linear Slope Diff in DC1 DBT-IE-IP|-0.046|STANDARD_ERROR_OF_MEAN|0.097||0.632|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to IP.||||.632
71731376|NCT02639338|142977427|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|Binomial Test|||||||<0.001
71731377|NCT02639338|142977427|SUPERIORITY|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|2-sided exact 1-sample binomial test|||||||<0.001
71731378|NCT01688921|142977434|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.12|0.88|
71731379|NCT01688921|142977435|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.21|0.96|
71772215|NCT04626310|143044741|SUPERIORITY||Linear Slope Diff in DC1 DBT-ER-DBT-IE|0.144|STANDARD_ERROR_OF_MEAN|0.107||0.178|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared DBT-IE to DBT-ER.||||.178
71772216|NCT04626310|143044741|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-IP|0.045|STANDARD_ERROR_OF_MEAN|0.112||0.689|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to IP.||||.689
71772217|NCT04626310|143044741|SUPERIORITY||Linear Slope Diff in DC2 DBT-IE-IP|-0.011|STANDARD_ERROR_OF_MEAN|0.109||0.917|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-IE to IP.||||.917
71772218|NCT04626310|143044741|SUPERIORITY||Linear Slope Diff in DC2 DBT-ER-DBT-IE|0.056|STANDARD_ERROR_OF_MEAN|0.108||0.603|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC2 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the slope differences DBT-ER to DBT-IE.||||.603
71831392|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.44||0.2049|TWO_SIDED|95.0|-1.7|7.91|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||7.91|-1.70|0.2049
71831393|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|4.68|STANDARD_ERROR_OF_MEAN|2.4||0.0527|TWO_SIDED|95.0|-0.05|9.41|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||9.41|-0.05|0.0527
71831394|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.82||0.3699|TWO_SIDED|95.0|-5.21|1.94|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.94|-5.21|0.3699
71831395|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.83||0.7945|TWO_SIDED|95.0|-4.06|3.11|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.11|-4.06|0.7945
71831396|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|2.03||0.941|TWO_SIDED|95.0|-4.13|3.83|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.83|-4.13|0.9410
71772219|NCT04626310|143044742|SUPERIORITY||Other[Quad Slope difference DBT-ER-IP]|0.013|STANDARD_ERROR_OF_MEAN|0.044||0.762|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.762
71772220|NCT04626310|143044742|SUPERIORITY||Quad Slope difference DBT-IE-IP|0.034|STANDARD_ERROR_OF_MEAN|0.047||0.478|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.478
71731380|NCT01688921|142977436|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.83|1.06||||||For a sample size of 550 per group each test has an individual power of \> 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||1.06|0.83|
71731381|NCT01688921|142977437|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.|Seroconversion Rate Difference|0.8|||||TWO_SIDED|95.0|-4.8|6.5||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||6.5|-4.8|
71731382|NCT01688921|142977438|NON_INFERIORITY_OR_EQUIVALENCE|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points|Seroconversion Rate Difference|1.3|||||TWO_SIDED|95.0|-4.5|7.1||||||For a sample size of 550 per group each test has an individual power of \> 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||7.1|-4.5|
71731383|NCT01688921|142977439|NON_INFERIORITY_OR_EQUIVALENCE|"Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of \<10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.~The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively)."|Seroconversion Rate Difference|0.3|||||TWO_SIDED|95.0|-5.2|5.9||||||For a sample size of 550 per group each test has an individual power of \> 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is \> 80%, computed as product of 6 individual powers.||5.9|-5.2|
71731384|NCT01688921|142977440|NON_INFERIORITY_OR_EQUIVALENCE|Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71731385|NCT01688921|142977441|NON_INFERIORITY_OR_EQUIVALENCE|The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.|||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71731386|NCT03131596|142977455|SUPERIORITY|||||||0.012||||||The p-value is not adjusted and a p-value of \< 0.05 is considered statistically significant.|Chi-squared|||200 patients were eligible and randomised in a 1:1 fashion. 9 patients did not complete the full protocol, resulting in 94 cases in the balloon group and 97 cases in the control group included in the final analysis. Intention-to-treat analysis was conducted.The null hypothesis is the percentage of the patients with reformed uterine adhesion in balloon group will less than the percentage of the patients with reformed uterine adhesion in control group. A Chi-squared analysis was used.||||0.012
71731387|NCT03131596|142977456|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71731388|NCT03131596|142977457|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71731389|NCT03131596|142977458|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71731390|NCT00734071|142977459|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.911||0.518|TWO_SIDED|95.0|-1.2|2.38||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||2.38|-1.20|0.518
71731391|NCT00734071|142977460|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.542||0.685|TWO_SIDED|95.0|-1.29|0.85||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05).||0.85|-1.29|0.685
71731392|NCT00734071|142977461|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.984|TWO_SIDED|95.0|-0.27|0.28||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||0.28|-0.27|0.984
71731393|NCT00734071|142977462|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.866||0.703|TWO_SIDED|95.0|-1.38|2.04||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||2.04|-1.38|0.703
71772221|NCT04626310|143044742|SUPERIORITY||Quad Slope difference DBT-ER-DBT-IE|-0.089|STANDARD_ERROR_OF_MEAN|0.054||0.705|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. DBT-IE) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.705
71658918|NCT03276221|142833403|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.07||0.226|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.226
71661193|NCT00945100|142835963|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.||||>0.99
71731394|NCT00734071|142977463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.602|TWO_SIDED|95.0|0.713|1.795|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||1.795|0.713|0.602
71731395|NCT00734071|142977464|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|1.558||0.995|TWO_SIDED|95.0|-3.09|3.07||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||3.07|-3.09|0.995
71731396|NCT00734071|142977465|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|2.951||0.731|TWO_SIDED|95.0|-4.79|6.83||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P\<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements|||||6.83|-4.79|0.731
71731397|NCT00541346|142977486|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|26.3|||<|0.001|TWO_SIDED|95.0|19.6|33.1||Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||33.1|19.6|<0.001
71731398|NCT00541346|142977487|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|23.1|||<|0.001|TWO_SIDED|95.0|16.9|29.3||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||29.3|16.9|<0.001
71731399|NCT00541346|142977488|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|10.9|||<|0.001|TWO_SIDED|95.0|5.4|16.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.||Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||16.8|5.4|<0.001
71731400|NCT00541346|142977489|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.2|||<|0.001|TWO_SIDED|95.0|3.3|11.1||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||11.1|3.3|<0.001
71739112|NCT00988091|142991043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.081|TWO_SIDED|95.0|0.483|1.044||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p \<0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.\[||1.044|0.483|0.081
71831397|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.05||0.486|TWO_SIDED|95.0|-5.44|2.59|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.59|-5.44|0.4860
71661194|NCT00945100|142835965|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.||||0.12
71658919|NCT03276221|142833404|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.369|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.369
71658920|NCT03276221|142833405|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.647|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.647
71731401|NCT00541346|142977490|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|4.1|||<|0.01||95.0|1.2|6.9||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.9|1.2|<0.01
71731402|NCT00541346|142977491|SUPERIORITY_OR_OTHER||Bayesian random intercept model.|3.5|||<|0.001|TWO_SIDED|95.0|1.8|5.2||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||5.2|1.8|<0.001
71731403|NCT00541346|142977492|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-10.9|||<|0.001|TWO_SIDED|95.0|-16.8|-5.4||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-5.4|-16.8|<0.001
71731404|NCT00541346|142977493|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|1.94|||>|0.21|TWO_SIDED|95.0|-2.98|6.82||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||6.82|-2.98|>0.21
71731405|NCT00541346|142977494|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-3.4|||>|0.06|TWO_SIDED|95.0|-7.9|0.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||0.80|-7.9|>0.06
71772222|NCT04626310|143044743|SUPERIORITY||Quad slope difference DBT-ER-IP|-0.028|STANDARD_ERROR_OF_MEAN|0.15||0.93|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-ER vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.93
71772223|NCT04626310|143044743|SUPERIORITY||Quad slope difference DBT-IE-IP|-0.029|STANDARD_ERROR_OF_MEAN|0.145||0.836|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.836
71772224|NCT04626310|143044743|SUPERIORITY||Quad slope difference DBT-ER-DBT-IE|0.001|STANDARD_ERROR_OF_MEAN|0.145||0.994|TWO_SIDED||||||Mixed Models Analysis|||Comparisons of Quadratic Slopes (DBT-IE vs. IP) in latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) with quadratic effects.||||.994
71731406|NCT00541346|142977495|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|-5.26|||<|0.01|TWO_SIDED|95.0|-9.37|-1.18||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.||-1.18|-9.37|<0.01
71772225|NCT04626310|143044744|SUPERIORITY||Quad slope diff in DC1 DBT-ER-IP|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.313|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to IP.||||.313
71772226|NCT04626310|143044744|SUPERIORITY||Quad Slope in DC1 DBT-IE-IP|0.003|STANDARD_ERROR_OF_MEAN|0.01||0.747|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-IE to IP.||||.747
71772227|NCT04626310|143044744|SUPERIORITY||Quad slope diff in DC1 DBT-ER-DBT-IE|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.444|TWO_SIDED||||||Mixed Models Analysis|||Latent growth curve models (in multilevel/mixed effects framework, Mplus v8.1) were estimated with maximum likelihood. Simple slopes of DC1 over weeks were calculated for each condition. Models tested whether these slopes differed by condition. This test compared the quadratic effects differed DBT-ER to DBT-IE.||||.444
71772228|NCT02278341|143044745|NON_INFERIORITY|Non Inferiority, Margin = -0.75|LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.132|0.339||p-value for non-inferiority test based on 1-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb and baseline Hb by visit as continuous variable.||0.339|0.132|<0.001
71772229|NCT02278341|143044746|NON_INFERIORITY|Non-Inferiority, Margin = -0.75|LSM Difference|0.171|||<|0.001|TWO_SIDED|95.0|0.082|0.261||p-value for non-inferiority test based on 1-sided significance level.|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable. Statistical analysis used was ANCOVA model with multiple imputations (MI). Missing hemoglobin data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the MCMC imputation model.||0.261|0.082|<0.001
71772230|NCT02278341|143044747|NON_INFERIORITY|Non-inferiority of roxadustat versus ESA (the non-inferiority margin for the difference between groups is -15%).|Difference of Percentages|2.3|||<|0.05|TWO_SIDED|95.0|-2.9|7.6||p-value for non-inferiority test based on 1-sided significance level.|Miettinen and Nurminen|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||7.6|-2.9|<0.05
71772231|NCT02278341|143044748|SUPERIORITY||LSM Difference|-0.377|||<|0.001|TWO_SIDED|95.0|-0.451|-0.304||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline LDL, baseline Hb as continuous variables.||-0.304|-0.451|<0.001
71772232|NCT02278341|143044749|SUPERIORITY||LSM Difference|-31.9|||<|0.001|TWO_SIDED|95.0|-41.4|-22.4||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-22.4|-41.4|<0.001
71772233|NCT02278341|143044750|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.205|||<|0.05|TWO_SIDED|95.0|-0.649|1.059||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 PF, baseline Hb as continuous variables.||1.059|-0.649|<0.05
71772234|NCT02278341|143044751|NON_INFERIORITY|The margin for non-inferiority was -3.|LSM Difference|0.856|||<|0.05|TWO_SIDED|95.0|-0.115|1.828|||Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits (week 8, week 12, week 28) and visit by treatment as categorical variables, and baseline SF-36 VT, baseline Hb as continuous variables.||1.828|-0.115|<0.05
71772235|NCT02278341|143044752|NON_INFERIORITY|The margin for non-inferiority was 1.|LSM Difference|-0.849|||<|0.05|TWO_SIDED|95.0|-1.971|0.273||p-value for non-inferiority test based on 1-sided significance level|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.273|-1.971|<0.05
71772236|NCT02278341|143044753|NON_INFERIORITY|Non-inferiority (hazard ratio margin of 1.3).|Hazard Ratio (HR)|0.924|||<|0.05|TWO_SIDED|95.0|0.669|1.276||p-value for non-inferiority test based on 1-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Non-inferiority was declared if the upper bound of the 95% CI is below 1.3.||1.276|0.669|<0.05
71772237|NCT02278341|143044754|SUPERIORITY||LSM Difference|-0.579|||=|0.308|TWO_SIDED|95.0|-1.694|0.536||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables, and baseline MAP, baseline Hb as continuous variables.||0.536|-1.694|=0.308
71731407|NCT00541346|142977496|SUPERIORITY_OR_OTHER||Bayesian Mean Change Score|7.6|||>|0.11|TWO_SIDED|95.0|-5.6|20.7||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.||20.7|-5.6|>0.11
71731408|NCT04732949|142977497|OTHER||Hazard Ratio (HR)|1.06||||0.509|TWO_SIDED|95.0|0.89|1.27|||Cox proportional hazard model|||Hazard Ratio for time to hospital discharge - SNG001 vs Placebo||1.27|0.89|0.509
71731409|NCT04732949|142977498|OTHER||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.81|1.28|||Cox proportional hazard model|||Hazard Ratio for time to OSCI recovery - SNG001 vs Placebo||1.28|0.81|0.888
71731410|NCT04732949|142977499|OTHER||Odds Ratio (OR)|0.71||||0.161|TWO_SIDED|95.0|0.44|1.15|||Regression, Logistic|||Odds Ratio for progression to severe disease or death - SNG001 vs Placebo||1.15|0.44|0.161
71731411|NCT04732949|142977500|OTHER||Odds Ratio (OR)|0.85||||0.61|TWO_SIDED|95.0|0.45|1.61|||Regression, Logistic|||Odds Ratio for intubation or death - SNG001 vs Placebo||1.61|0.45|0.610
71731412|NCT04732949|142977501|OTHER||Odds Ratio (OR)|0.79||||0.544|TWO_SIDED|95.0|0.38|1.67|||Regression, Logistic|||Odds Ratio for death - SNG001 vs Placebo||1.67|0.38|0.544
71731413|NCT04732949|142977502|OTHER||Odds Ratio (OR)|1.18||||0.323|TWO_SIDED|95.0|0.85|1.64|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 7) - SNG001 vs Placebo||1.64|0.85|0.323
71661195|NCT00945100|142835969|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.28
71731414|NCT04732949|142977502|OTHER||Odds Ratio (OR)|1.17||||0.406|TWO_SIDED|95.0|0.81|1.7|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 14) - SNG001 vs Placebo||1.70|0.81|0.406
71731415|NCT04732949|142977502|OTHER||Odds Ratio (OR)|0.96||||0.828|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 21) - SNG001 vs Placebo||1.43|0.64|0.828
71731416|NCT04732949|142977502|OTHER||Odds Ratio (OR)|0.92||||0.706|TWO_SIDED|95.0|0.61|1.4|||Regression, Logistic|||Odds Ratio for hospital discharge (Day 28) - SNG001 vs Placebo||1.40|0.61|0.706
71731417|NCT04732949|142977503|OTHER||Odds Ratio (OR)|1.71||||0.101|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 7) - SNG001 vs Placebo||3.22|0.90|0.101
71731418|NCT04732949|142977503|OTHER||Odds Ratio (OR)|0.99||||0.942|TWO_SIDED|95.0|0.67|1.45|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 14) - SNG001 vs Placebo||1.45|0.67|0.942
71731419|NCT04732949|142977503|OTHER||Odds Ratio (OR)|0.96||||0.824|TWO_SIDED|95.0|0.68|1.35|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 21) - SNG001 vs Placebo||1.35|0.68|0.824
71731420|NCT04732949|142977503|OTHER||Odds Ratio (OR)|0.92||||0.613|TWO_SIDED|95.0|0.66|1.28|||Regression, Logistic|||Odds Ratio for OSCI recovery (Day 28) - SNG001 vs Placebo||1.28|0.66|0.613
71731421|NCT04732949|142977505|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||SNG001 vs Placebo||0.3|-0.1|0.410
71731422|NCT02853435|142977522|OTHER||Ratio of geometric LS means|1.0417|||||TWO_SIDED|90.0|0.9809|1.1063|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1063|0.9809|
71731423|NCT02853435|142977522|OTHER||Ratio of geometric LS means|1.1108|||||TWO_SIDED|90.0|1.0459|1.1797|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).|||1.1797|1.0459|
71731424|NCT02853435|142977523|OTHER||Ratio of geometric LS means|1.0408|||||TWO_SIDED|90.0|0.9792|1.1062|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1062|0.9792|
71731425|NCT02853435|142977523|OTHER||Ratio of geometric LS means|1.1138|||||TWO_SIDED|90.0|1.0479|1.1838|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).|||1.1838|1.0479|
71731426|NCT02853435|142977525|OTHER||Ratio of geometric LS means|0.9586|||||TWO_SIDED|90.0|0.844|1.0888|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.0888|0.8440|
71731427|NCT02853435|142977525|OTHER||Ratio of geometric LS means|1.1487|||||TWO_SIDED|90.0|1.0113|1.3047|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.|||1.3047|1.0113|
71739113|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.008
71731428|NCT02853435|142977526|OTHER||Median Difference (Final Values)|-0.233||||0.309|TWO_SIDED|90.0|-0.267|0.0||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||0.000|-0.267|0.309
71731429|NCT02853435|142977526|OTHER||Median Difference (Final Values)|-0.492|||<|0.001|TWO_SIDED|90.0|-0.5|-0.25||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.|||-0.250|-0.500|<0.001
71731430|NCT04172467|142977685|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|4.49|||<|0.001|TWO_SIDED|95.0|3.72|5.42||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||5.42|3.72|<0.001
71731431|NCT04172467|142977685|OTHER|To estimate the relevance of guideline adherent treatment (GLAD) for the susceptibility to infection, full GLAD is taken as reference category.|Hazard Ratio (HR)|2.52|||<|0.001|TWO_SIDED|95.0|1.98|3.21||For effect estimation, hazard ratios are reported with 95% confidence interval. The significance level is set to two-sided ≤ 5% (p ≤ 0.05).|Regression, Cox|The Model developed by Anderson and Gill (1982) is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis.||For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model. This model is an extension to the proportional hazard model (Cox model) for time to recurrent event analysis. The null hypothesis is that the GLAD-Score has no effect on susceptibility to infection.||3.21|1.98|<0.001
71731432|NCT04332614|142977686|SUPERIORITY||Odds Ratio (OR)|0.8791371||||0.0248|TWO_SIDED|95.0|0.7856042|0.9838058||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9838058|0.7856042|0.0248
71731433|NCT04332614|142977686|SUPERIORITY||Odds Ratio (OR)|0.5980109|||<|0.0001|TWO_SIDED|95.0|0.5159511|0.6931219||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6931219|0.5159511|<0.0001
71731434|NCT04332614|142977686|SUPERIORITY||Odds Ratio (OR)|0.8380003||||0.0133|TWO_SIDED|95.0|0.7285712|0.9638653||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9638653|0.7285712|0.0133
71731435|NCT04332614|142977687|SUPERIORITY||Odds Ratio (OR)|0.3700794|||<|0.0001|TWO_SIDED|95.0|0.2870513|0.4771231||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4771231|0.2870513|<0.0001
71731436|NCT04332614|142977687|SUPERIORITY||Odds Ratio (OR)|0.285144|||<|0.0001|TWO_SIDED|95.0|0.1881589|0.4321194||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4321194|0.1881589|<0.0001
71731437|NCT04332614|142977687|SUPERIORITY||Odds Ratio (OR)|0.5565905||||0.0003|TWO_SIDED|95.0|0.4059477|0.7631354||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.7631354|0.4059477|0.0003
71731438|NCT04332614|142977688|SUPERIORITY||Odds Ratio (OR)|0.72429741||||0.103|TWO_SIDED|95.0|0.49167734|1.0669736||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.0669736|0.49167734|0.103
71731439|NCT04332614|142977688|SUPERIORITY||Odds Ratio (OR)|0.63578603||||0.12|TWO_SIDED|95.0|0.35943749|1.1246013||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.1246013|0.35943749|0.120
71731440|NCT04332614|142977688|SUPERIORITY||Odds Ratio (OR)|1.06482385||||0.789|TWO_SIDED|95.0|0.67282661|1.6852036||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.6852036|0.67282661|0.789
71731441|NCT04332614|142977689|SUPERIORITY||Odds Ratio (OR)|0.8837908||||0.0286|TWO_SIDED|95.0|0.7912382|0.9871694||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.9871694|0.7912382|0.0286
71731442|NCT04332614|142977689|SUPERIORITY||Odds Ratio (OR)|0.6000149|||<|0.0001|TWO_SIDED|95.0|0.5193168|0.6932528||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.6932528|0.5193168|<0.0001
71731443|NCT04332614|142977689|SUPERIORITY||Odds Ratio (OR)|0.8225743||||0.0055|TWO_SIDED|95.0|0.7167043|0.9440832|||Regression, Logistic|||||0.9440832|0.7167043|0.0055
71731444|NCT04332614|142977690|SUPERIORITY||Odds Ratio (OR)|0.3948795|||<|0.0001|TWO_SIDED|95.0|0.310437|0.5022914||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.5022914|0.3104370|<0.0001
71731445|NCT04332614|142977690|SUPERIORITY||Odds Ratio (OR)|0.2790595|||<|0.0001|TWO_SIDED|95.0|0.1875017|0.4153254||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.4153254|0.1875017|<0.0001
71731446|NCT04332614|142977690|SUPERIORITY||Odds Ratio (OR)|0.6097538||||0.0011|TWO_SIDED|95.0|0.4528751|0.8209762||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||0.8209762|0.4528751|0.0011
71772238|NCT02278341|143044755|SUPERIORITY||Hazard Ratio (HR)|0.915|||=|0.582|TWO_SIDED|95.0|0.668|1.254||p-value for superiority test based on 2-sided significance level.|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI is lower than 1.||1.254|0.668|=0.582
71772239|NCT02278341|143044756|SUPERIORITY||Difference of Percentages|1.4|||=|0.609|TWO_SIDED|95.0|-3.8|6.5||p-value for superiority test based on 2-sided significance level|Miettinen and Nurminen method|||A generalized linear model was used to estimate the difference in response rates between the arms, as an approximation for the Miettinen and Nurminen method, adjusting for following covariates: region, previous ESA treatment, cardiovascular history and baseline Hb as categorical variables.||6.5|-3.8|=0.609
71658921|NCT03276221|142833406|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.511|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the verbal recognition memory module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct choice for the abstinence group above and beyond the monitoring group (positive values indicate higher memory performance for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.511
71658922|NCT03276221|142833407|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.312|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.312
71731447|NCT04332614|142977691|SUPERIORITY||Odds Ratio (OR)|1.0049587||||0.976|TWO_SIDED|95.0|0.72693253|1.3893201||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.3893201|0.72693253|0.976
71731448|NCT04332614|142977691|SUPERIORITY||Odds Ratio (OR)|0.7576895||||0.246|TWO_SIDED|95.0|0.4741259|1.2108458||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.2108458|0.47412590|0.246
71731449|NCT04332614|142977691|SUPERIORITY||Odds Ratio (OR)|1.1728665||||0.428|TWO_SIDED|95.0|0.79090107|1.7393021||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model.|Regression, Logistic|||||1.7393021|0.79090107|0.428
71731450|NCT04332614|142977692|SUPERIORITY||Odds Ratio (OR)|0.9980487||||1|TWO_SIDED|95.0|0.8680298|1.147543||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.147543|0.8680298|1
71731451|NCT04332614|142977692|SUPERIORITY||Odds Ratio (OR)|0.8953032||||0.276|TWO_SIDED|95.0|0.7771682|1.031395||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.031395|0.7771682|0.276
71731452|NCT04332614|142977692|SUPERIORITY||Odds Ratio (OR)|0.8970536||||0.289|TWO_SIDED|95.0|0.7785981|1.033531||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.033531|0.7785981|0.289
71731453|NCT04332614|142977693|SUPERIORITY||Odds Ratio (OR)|0.9313889||||0.94591|TWO_SIDED|95.0|0.6003591|1.444944||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.444944|0.6003591|0.94591
71731454|NCT04332614|142977693|SUPERIORITY||Odds Ratio (OR)|1.8998642||||0.0041|TWO_SIDED|95.0|1.2809137|2.817898||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.817898|1.2809137|0.0041
71731455|NCT04332614|142977693|SUPERIORITY||Odds Ratio (OR)|2.0398184||||0.0015|TWO_SIDED|95.0|1.3648075|3.048678||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||3.048678|1.3648075|0.0015
71731456|NCT04332614|142977694|SUPERIORITY||Odds Ratio (OR)|1.180837||||0.829|TWO_SIDED|95.0|0.6750639|2.065546||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.065546|0.6750639|0.829
71731457|NCT04332614|142977694|SUPERIORITY||Odds Ratio (OR)|1.432003||||0.404|TWO_SIDED|95.0|0.8279689|2.476702||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.476702|0.8279689|0.404
71772240|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.164|||<|0.001|TWO_SIDED|95.0|0.072|0.256||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 1- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.256|0.072|<0.001
71731458|NCT04332614|142977694|SUPERIORITY||Odds Ratio (OR)|1.212702||||0.753|TWO_SIDED|95.0|0.7161724|2.05348||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.053480|0.7161724|0.753
71731459|NCT04332614|142977695|SUPERIORITY||Odds Ratio (OR)|0.9747188||||0.9284|TWO_SIDED|95.0|0.8501783|1.1175028||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.1175028|0.8501783|0.9284
71731460|NCT04332614|142977695|SUPERIORITY||Odds Ratio (OR)|0.8518974||||0.0612|TWO_SIDED|95.0|0.741461|0.9787827||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||0.9787827|0.7414610|0.0612
71658923|NCT03276221|142833408|SUPERIORITY||Slope|1.92|STANDARD_ERROR_OF_MEAN|9.27||0.836|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate higher slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.836
71658924|NCT03276221|142833409|SUPERIORITY||Slope|-0.5|STANDARD_ERROR_OF_MEAN|3.93||0.898|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median incongruency cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for incongruent trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.898
71658925|NCT03276221|142833410|SUPERIORITY||Slope|16.54|STANDARD_ERROR_OF_MEAN|9.05||0.068|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the multitasking test module. The a priori threshold for statistical significance was 0.0125.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the multitasking cost for the abstinence group above and beyond the monitoring group (positive values indicate higher costs for multitasking trials for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.068
71661196|NCT00945100|142835972|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.||||0.45
71731461|NCT04332614|142977695|SUPERIORITY||Odds Ratio (OR)|0.873993||||0.1407|TWO_SIDED|95.0|0.7602296|1.0047804||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.0047804|0.7602296|0.1407
71731462|NCT04332614|142977696|SUPERIORITY||Odds Ratio (OR)|0.9089673||||0.8848|TWO_SIDED|95.0|0.6109603|1.352333||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.352333|0.6109603|0.8848
71731463|NCT04332614|142977696|SUPERIORITY||Odds Ratio (OR)|1.6914929||||0.0127|TWO_SIDED|95.0|1.1762411|2.43245||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.432450|1.1762411|0.0127
71731464|NCT04332614|142977696|SUPERIORITY||Odds Ratio (OR)|1.8608951||||0.0033|TWO_SIDED|95.0|1.2800275|2.705356||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||2.705356|1.2800275|0.0033
71731465|NCT04332614|142977697|SUPERIORITY||Odds Ratio (OR)|0.8619131||||0.759|TWO_SIDED|95.0|0.5709078|1.301251||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.301251|0.5709078|0.759
71661197|NCT00265395|142836028|SUPERIORITY_OR_OTHER||SVR Rate Difference|-4.9||||0.6445||95.0|-20.4|10.6|||Asymptotic Z-test|||||10.6|-20.4|0.6445
71731466|NCT04332614|142977697|SUPERIORITY||Odds Ratio (OR)|1.0950508||||0.897|TWO_SIDED|95.0|0.7331329|1.635633||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.635633|0.7331329|0.897
71731467|NCT04332614|142977697|SUPERIORITY||Odds Ratio (OR)|1.2704886||||0.498|TWO_SIDED|95.0|0.8377249|1.926816||We used an a priori threshold of p \< .05. All 3 comparisons run within same logistic regression model, correcting for the 3 pairwise comparisons using Tukey's Contrasts.|Regression, Logistic|||||1.926816|0.8377249|0.498
71731468|NCT02937766|142977718|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.25||0.093|TWO_SIDED|95.0|-0.1|0.9|||t-test, 2 sided|The t-test tested the hypothesis of no treatment difference between treatment groups.||||0.9|-0.1|0.093
71731469|NCT02937766|142977719|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.234|TWO_SIDED|95.0|-0.2|0.7||The t-test tested the hypothesis of no treatment difference between treatment groups.|t-test, 2 sided|||||0.7|-0.2|0.234
71731470|NCT04271475|142977735|SUPERIORITY||Least square mean|-16.1|STANDARD_ERROR_OF_MEAN|8.2||0.974|TWO_SIDED|95.0|-32.34|0.16|||MMRM||Least square mean and SE of the mean was estimated by mixed model repeated measurements method.|||0.16|-32.34|0.974
71731471|NCT00733135|142977744|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||GEE|||||||<0.05
71731472|NCT00159913|142977750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|3.98||0.056||95.0|-0.19|15.6||No adjustments for multiple comparisons have been made.|ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||15.60|-0.19|0.056
71731473|NCT00159913|142977750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.81|STANDARD_ERROR_OF_MEAN|5.0||||95.0|-6.11|13.73|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||13.73|-6.11|
71658926|NCT03276221|142833411|SUPERIORITY||Slope|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.15|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making a correct response for the abstinence group above and beyond the monitoring group (positive values indicate higher accuracy for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.150
71731474|NCT00159913|142977750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.33|STANDARD_ERROR_OF_MEAN|4.84||||95.0|1.72|20.94|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||20.94|1.72|
71731475|NCT00159913|142977750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.98|STANDARD_ERROR_OF_MEAN|4.85||||95.0|-1.64|17.6|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.||||17.60|-1.64|
71731476|NCT00159913|142977751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.172||95.0|-7.5|1.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.3|-7.5|0.172
71731477|NCT00159913|142977751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.1||||95.0|-4.5|7.6|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||7.6|-4.5|
71731478|NCT00159913|142977751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-8.9|1.9|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||1.9|-8.9|
71731479|NCT00159913|142977751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-12.4|-2.1|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers||||-2.1|-12.4|
71731480|NCT00159913|142977752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.0||0.041||95.0|-8.0|-0.2|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-0.2|-8.0|0.041
71731481|NCT00159913|142977752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||||95.0|-5.9|4.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||4.7|-5.9|
71731482|NCT00159913|142977752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-9.3|0.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||0.3|-9.3|
71772241|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.443|||<|0.001|TWO_SIDED|95.0|0.339|0.546||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 2- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.546|0.339|<0.001
71731483|NCT00159913|142977752|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|2.3||||95.0|-11.7|-2.7|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed||||-2.7|-11.7|
71731484|NCT00159913|142977753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|2.36||0.795||95.0|-4.07|5.3|||ANCOVA|The model included the covariates etiology and weight group||||5.30|-4.07|0.795
71731485|NCT00159913|142977753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|2.99||||95.0|-3.31|8.54|||ANCOVA|The model included the covariates etiology and weight group||||8.54|-3.31|
71731486|NCT00159913|142977753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.92||||95.0|-7.09|4.5|||ANCOVA|The model included the covariates etiology and weight group||||4.50|-7.09|
71731487|NCT00159913|142977753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.24|6.28|||ANCOVA|The model included the covariates etiology and weight group||||6.28|-5.24|
71731488|NCT00159913|142977754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.24|STANDARD_ERROR_OF_MEAN|6.2||0.139||95.0|-3.05|21.54|||ANCOVA|The model included the covariates etiology and weight group||||21.54|-3.05|0.139
71731489|NCT00159913|142977754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|7.84||||95.0|-5.21|25.9|||ANCOVA|The model included the covariates etiology and weight group||||25.90|-5.21|
71731490|NCT00159913|142977754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.43|STANDARD_ERROR_OF_MEAN|7.67||||95.0|-3.78|26.64|||ANCOVA|The model included the covariates etiology and weight group||||26.64|-3.78|
71731491|NCT00159913|142977754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|7.62||||95.0|-9.16|21.08|||ANCOVA|The model included the covariates etiology and weight group||||21.08|-9.16|
71731492|NCT00159913|142977755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.1||0.172||95.0|-7.1|1.3|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.3|-7.1|0.172
71731493|NCT00159913|142977755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.9||||95.0|-5.5|5.9|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||5.9|-5.5|
71731494|NCT00159913|142977755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-8.5|1.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.7|-8.5|
71731495|NCT00159913|142977755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-10.3|-0.7|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||-0.7|-10.3|
71731496|NCT00159913|142977756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.3||0.015||95.0|0.14|1.34|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.34|0.14|0.015
71731497|NCT00159913|142977756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.41||||95.0|-0.1|1.52|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.52|-0.10|
71661198|NCT00123474|142836029|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-6.0|11.6||||||6 Month Analysis||11.6|-6.0|
71731498|NCT00159913|142977756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.37||||95.0|-0.12|1.35|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.35|-0.12|
71731499|NCT00159913|142977756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.35||||95.0|0.21|1.58|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.58|0.21|
71731500|NCT00159913|142977757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.64||0.44||95.0|-1.77|0.77|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.77|-1.77|0.440
71731501|NCT00159913|142977757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.88||||95.0|-1.91|1.57|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.57|-1.91|
71731502|NCT00159913|142977757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.78||||95.0|-1.73|1.36|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||1.36|-1.73|
71731503|NCT00159913|142977757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.75||||95.0|-2.61|0.33|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test||||0.33|-2.61|
71731504|NCT00159913|142977758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.93||0.75||95.0|-4.45|3.21|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||3.21|-4.45|0.750
71772242|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.561|||<|0.001|TWO_SIDED|95.0|0.451|0.672||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 3 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.672|0.451|<0.001
71661199|NCT00123474|142836030|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-6.8|10.6||||||||10.6|-6.8|
71731505|NCT00159913|142977758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|2.57||||95.0|-4.21|5.95|||ANCOVA|||||5.95|-4.21|
71731506|NCT00159913|142977758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.49||||95.0|-4.68|5.15|||ANCOVA|||||5.15|-4.68|
71731507|NCT00159913|142977758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.96|STANDARD_ERROR_OF_MEAN|2.23||||95.0|-7.37|1.45|||ANCOVA|||||1.45|-7.37|
71731508|NCT00159913|142977759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|1.51||0.784||95.0|-3.41|2.58|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.||||2.58|-3.41|0.784
71731509|NCT00159913|142977759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.97||||95.0|-3.49|4.3|||ANCOVA|||||4.30|-3.49|
71731510|NCT00159913|142977759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.96||||95.0|-5.99|1.77|||ANCOVA|||||1.77|-5.99|
71772243|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.708|||<|0.001||95.0|0.588|0.828||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 4 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.828|0.588|<0.001
71731511|NCT00159913|142977759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.77||||95.0|-3.06|3.97|||ANCOVA|||||3.97|-3.06|
71731512|NCT00159913|142977760|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.83||||0.184||95.0|0.75|4.45|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||4.45|0.75|0.184
71731513|NCT00159913|142977760|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.409||95.0|0.18|2.01|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||2.01|0.18|0.409
71731514|NCT00159913|142977760|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.146||95.0|0.75|6.69|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||6.69|0.75|0.146
71731515|NCT00159913|142977760|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.52||||0.006||95.0|1.56|13.1|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.||||13.10|1.56|0.006
71731516|NCT00159913|142977761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.89|STANDARD_ERROR_OF_MEAN|4.35||0.179||95.0|-2.74|14.53|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||14.53|-2.74|0.179
71888946|NCT02939131|143298793|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.6|TWO_SIDED|95.0|-25.4|15.4|||t-test, 2 sided||A positive value would indicate the site-level percentages of those on medications were higher in the COMB-R group.|This is the analysis of the percent of participants on non-antidepressant psychiatric medications. Site-level percentages were compared across treatments.||15.4|-25.4|0.60
71888947|NCT02939131|143298794|SUPERIORITY||Mean Difference (Final Values)|-3.8||||0.77|TWO_SIDED|95.0|-32.5|24.8|||t-test, 2 sided||A positive difference would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on any psychiatric medication across treatment groups.||24.8|-32.5|0.77
71888948|NCT02939131|143298794|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.91|TWO_SIDED|95.0|-37.3|33.5|||t-test, 2 sided||A positive difference would indicate more study time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on single SSRI psychiatric medication across treatment groups.||33.5|-37.3|0.91
71888949|NCT02939131|143298794|SUPERIORITY||Mean Difference (Final Values)|-16.7||||0.4|TWO_SIDED|95.0|-60.2|26.9|||t-test, 2 sided||A positive value would indicate more time on medication in the COMB-R group.|This is the analysis comparing site-level mean percents of study time on SSRI+other psychiatric medication across treatment groups.||26.9|-60.2|0.40
71888950|NCT02939131|143298794|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.52|TWO_SIDED|95.0|-67.0|40.1|||t-test, 2 sided||A positive difference would indicate more time on medication in COMB-R group.|This is the analysis comparing site-level mean percents of study time on a single non-SSRI psychiatric medication across treatment groups.||40.1|-67.0|0.52
71888951|NCT02939131|143298794|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.96|TWO_SIDED|95.0|-778.0|785.7|||t-test, 2 sided|Because of sparseness, the confidence intervals for this site-level analysis are very large.|A positive difference indicates more time on medication in the COMB-R group. There was data from only one site in the ESC group and 2 sites in the COMB-R group. The confidence interval for the difference is quite large and the test is unreliable.|This is the analysis comparing site-level mean percents of study time on non-SSRI+other psychiatric medication across treatment groups. This analysis is unstable because of sparseness.||785.7|-778.0|0.96
71888952|NCT02939131|143298794|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.74|TWO_SIDED|95.0|-31.4|23.0|||t-test, 2 sided||A positive difference would reflect more time on medications in the COMB-R group|This is the analysis comparing site-level mean percents of study time on antidepressant medication across treatment groups.||23.0|-31.4|0.74
71731517|NCT00159913|142977761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|5.35||||95.0|-9.49|11.77|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||11.77|-9.49|
71731518|NCT00159913|142977761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|5.36||||95.0|0.66|21.96|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||21.96|0.66|
71731519|NCT00159913|142977761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.24|STANDARD_ERROR_OF_MEAN|5.16||||95.0|-5.02|15.5|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates||||15.50|-5.02|
71731520|NCT00824005|142977762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.9||0.169|TWO_SIDED|95.0|-0.42|2.34||No adjustment for multiple comparisons|t-test, 2 sided|||Compare the change in the cell group to the change in the placebo group.||2.34|-0.42|0.169
71772244|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.768|||<|0.001|TWO_SIDED|95.0|0.645|0.89||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 5 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.890|0.645|<0.001
71888953|NCT02939131|143298795|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.29|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||A positive difference would indicate the site level average interim counseling sessions was higher in the COMB-R group.|We compared the site-level average number of interim counseling sessions between treatment groups.||8.2|-2.8|0.29
71888954|NCT02939131|143298797|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.03|TWO_SIDED|95.0|0.02|0.38|||t-test, 2 sided||A positive difference indicates higher site-level averages in the COMB-R group.|The average score for all participants at each site was computed. These site-level averages were compared across treatment groups.||0.38|0.02|0.03
71658927|NCT03276221|142833412|SUPERIORITY||Slope|179.11|STANDARD_ERROR_OF_MEAN|281.76||0.525|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the one touch stockings of Cambridge module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.525
71731521|NCT00824005|142977763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|23.9||0.856|TWO_SIDED|95.0|-10.05|12.07|||t-test, 2 sided|||Change in the difference of end systolic volume over time.||12.07|-10.05|0.856
71731522|NCT00824005|142977764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|22.3||0.835|TWO_SIDED|95.0|-12.5|10.1||Is the change in percent reversible defect the same between the two groups|t-test, 2 sided|||Change in percent of the defect that is reversible||10.1|-12.5|0.835
71731523|NCT00824005|142977767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.471|TWO_SIDED|95.0|-0.3|0.14|||t-test, 2 sided|||Difference in the change between the two groups||0.14|-0.30|0.471
71731524|NCT00824005|142977768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.784||0.227|TWO_SIDED|95.0|-0.66|0.16|||t-test, 2 sided|||Change in average improvement in Canadian Class Score over time between the two groups.||0.16|-0.66|0.227
71731525|NCT00824005|142977769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.845||0.361|TWO_SIDED|95.0|-0.56|0.21|||t-test, 2 sided|||Difference in the change in NYHA score between the two groups||0.21|-0.56|0.361
71731526|NCT00824005|142977770|SUPERIORITY_OR_OTHER||Difference in the proportion of particip|0.04|STANDARD_DEVIATION|0.045||0.28|TWO_SIDED|95.0|-0.01|0.09|||Chi-squared|||Difference in the change in anti-anginal meds across groups||0.09|-0.01|0.28
71731527|NCT00824005|142977771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|104.0|STANDARD_DEVIATION|409.0||0.302|TWO_SIDED|95.0|-95.0|303.0|||t-test, 2 sided|||Change in six minute walk distance||303|-95|0.302
71731528|NCT00824005|142977772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.7|STANDARD_DEVIATION|176.0||0.55|TWO_SIDED|95.0|-150.0|80.0|||t-test, 2 sided|||Difference in the change in BNP(reg) between cell and placebo group||80|-150|0.55
71731529|NCT00824005|142977773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.5|STANDARD_DEVIATION|31.2||0.198|TWO_SIDED|95.0|-5.03|23.93|||t-test, 2 sided|||Change in the difference of end diastolic volume between the two groups over time.||23.93|-5.03|0.198
71731530|NCT00824005|142977774|SUPERIORITY_OR_OTHER||Difference in the incidence rates|-0.047|STANDARD_ERROR_OF_MEAN|0.044||0.47|TWO_SIDED|95.0|-0.133|0.039|||t-test, 2 sided|||The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)||0.039|-0.133|0.47
71731531|NCT00824005|142977775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|8.4||0.7|TWO_SIDED|95.0|-4.78|3.36|||t-test, 2 sided|||Difference in the change between the two groups||3.36|-4.78|0.7
71731532|NCT01874275|142977778|SUPERIORITY_OR_OTHER|||||||0.2413|TWO_SIDED||||||Mixed Models Analysis|||||||0.2413
71731533|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted difference|0.18|||||TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 29||0.46|-0.11|
71731534|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.34|0.17|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 57||0.17|-0.34|
71888955|NCT02939131|143298798|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.69|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided||A positive difference would indicate the site-level averages were higher in the COMB-R group compared to the ESC group and vice versa|The average of scores for all participants' clinicians at each site was computed and these site-level averages were compared across treatments.||0.29|-0.43|0.69
71888956|NCT02939131|143298799|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.004|TWO_SIDED|95.0|0.26|1.03|||t-test, 2 sided||A positive difference would indicate site-level averages were higher for the COMB-R group than the ESC group and vice versa.|The average scores for all participants' prescribing clinicians at each site were computed and these site-level averages were compared across treatment groups.||1.03|0.26|0.004
71731535|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.08|||||TWO_SIDED|95.0|-0.37|0.2|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 85||0.20|-0.37|
71731536|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.23|||||TWO_SIDED|95.0|-0.5|0.04|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 113||0.04|-0.50|
71731537|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|0.03|||||TWO_SIDED|95.0|-0.26|0.32|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 141||0.32|-0.26|
71731538|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.13|||||TWO_SIDED|95.0|-0.41|0.15|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 169||0.15|-0.41|
71731539|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.12|||||TWO_SIDED|95.0|-0.38|0.13|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 197||0.13|-0.38|
71731540|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.04|||||TWO_SIDED|95.0|-0.32|0.25|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 225||0.25|-0.32|
71731541|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|0.08|||||TWO_SIDED|95.0|-0.19|0.36|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 253||0.36|-0.19|
71731542|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|0.13|||||TWO_SIDED|95.0|-0.12|0.38|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 281||0.38|-0.12|
71731543|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.27|0.22|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 309||0.22|-0.27|
71731544|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|-0.03|||||TWO_SIDED|95.0|-0.37|0.31|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 337||0.31|-0.37|
71731545|NCT00989235|142977784|SUPERIORITY_OR_OTHER||Adjusted Difference|0.23|||||TWO_SIDED|95.0|-0.09|0.55|||ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|Change from Baseline = Post-baseline - Baseline value.|Day 365||0.55|-0.09|
71731546|NCT00989235|142977785|SUPERIORITY_OR_OTHER||estimate of difference|0.4|||||TWO_SIDED|95.0|-17.2|18.0|||normal approximation|For 95% CI: normal approximation with continuity correction.||||18.0|-17.2|
71731547|NCT00989235|142977786|SUPERIORITY_OR_OTHER||estimate of difference|-8.6|||||TWO_SIDED|95.0|-20.3|3.2|||normal approximation|For 95% CI: normal approximation with continuity correction.||||3.2|-20.3|
71731548|NCT00989235|142977788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.45|1.69|||Cox proportional hazards model||Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.|Through Month 12||1.69|0.45|
71731549|NCT00989235|142977789|SUPERIORITY_OR_OTHER||estimate of difference|-1.1|||||TWO_SIDED|95.0|-12.9|10.7|||normal approximation|For 95% CI: normal approximation with continuity correction.||||10.7|-12.9|
71731550|NCT00989235|142977790|SUPERIORITY_OR_OTHER||estimate of difference|-7.7|||||TWO_SIDED|95.0|-22.6|7.3|||normal approximation|95% CI: normal approximation with continuity correction.||||7.3|-22.6|
71731551|NCT00989235|142977791|SUPERIORITY_OR_OTHER||estimate of difference|-10.6|||||TWO_SIDED|95.0|-31.1|10.0|||normal approximation|95% CI: normal approximation with continuity correction.||||10.0|-31.1|
71731552|NCT01318070|142977807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|95.0|-0.224|-0.135||||||||-0.135|-0.224|
71731553|NCT01318070|142977807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.225|-0.135||||||||-0.135|-0.225|
71731554|NCT01318070|142977808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|||||TWO_SIDED|95.0|-0.434|-0.292||||||||-0.292|-0.434|
71731555|NCT01318070|142977808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|||||TWO_SIDED|95.0|-0.432|-0.287||||||||-0.287|-0.432|
71731556|NCT01318070|142977809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.588|||||TWO_SIDED|95.0|-0.692|-0.484||||||||-0.484|-0.692|
71731557|NCT01318070|142977809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||||TWO_SIDED|95.0|-0.743|-0.526||||||||-0.526|-0.743|
71731558|NCT01318070|142977810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||||TWO_SIDED|95.0|-13.2|-4.47||||||||-4.47|-13.20|
71731559|NCT01318070|142977810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-17.86|-8.26||||||||-8.26|-17.86|
71731560|NCT01318070|142977811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.24|||||TWO_SIDED|95.0|-16.22|-6.25||||||||-6.25|-16.22|
71731561|NCT01318070|142977811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|||||TWO_SIDED|95.0|-20.0|-9.63||||||||-9.63|-20.00|
71772245|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.604|0.855||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 6 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.855|0.604|<0.001
71772246|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.729|||<|0.001|TWO_SIDED|95.0|0.603|0.856||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 7 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.856|0.603|<0.001
71772247|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.574|0.826||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 8 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.826|0.574|<0.001
71731562|NCT01318070|142977812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.88|||||TWO_SIDED|95.0|-18.09|-7.68||||||||-7.68|-18.09|
71731563|NCT01318070|142977812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||||TWO_SIDED|95.0|-22.64|-11.53||||||||-11.53|-22.64|
71731564|NCT01318070|142977813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.46|||||TWO_SIDED|95.0|-18.51|-6.4||||||||-6.40|-18.51|
71772248|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.659|||<|0.001|TWO_SIDED|95.0|0.53|0.788||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 10 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.788|0.530|<0.001
71772249|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.593|||<|0.001|TWO_SIDED|95.0|0.459|0.727||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 12 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.727|0.459|<0.001
71772250|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.503|||<|0.001|TWO_SIDED|95.0|0.366|0.64||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 14 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.640|0.366|<0.001
71731565|NCT01318070|142977813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.49|||||TWO_SIDED|95.0|-22.78|-10.19||||||||-10.19|-22.78|
71731566|NCT01318070|142977814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.31|||||TWO_SIDED|95.0|-21.51|-3.1||||||||-3.10|-21.51|
71731567|NCT01318070|142977814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-30.43|-11.95||||||||-11.95|-30.43|
71731568|NCT01318070|142977815|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.717|||||TWO_SIDED|95.0|-0.848|-0.586||||||||-0.586|-0.848|
71731569|NCT01318070|142977815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.773|||||TWO_SIDED|95.0|-0.913|-0.634||||||||-0.634|-0.913|
71731570|NCT00353873|142977840|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|7.6|STANDARD_ERROR_OF_MEAN|3.01||0.012|TWO_SIDED|95.0|1.7|13.5|||ANCOVA|||||13.5|1.7|0.012
71731571|NCT00353873|142977841|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.08||0.003|TWO_SIDED|95.0|3.2|15.3|||ANCOVA|||||15.3|3.2|0.003
71731572|NCT00353873|142977842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.389|TWO_SIDED|95.0|0.7|2.4|||Regression, Logistic|||||2.4|0.7|0.389
71888957|NCT02939131|143298800|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|0.16||||0.98|TWO_SIDED|95.0|-14.04|14.36|||t-test, 2 sided||We subtract group mean for ESC from group mean for COMB-R. The group means are the means of the site-level percentages of participants with events.|This is the analysis of new Grade 3+ signs/symptoms through week 24. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.36|-14.04|0.98
71731573|NCT00353873|142977843|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.535|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||||1.9|0.7|0.535
71731574|NCT00870194|142977849|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority Margin of 0.4%||||||0.012||95.0|||||Mixed Model Repeated Measures|||||||.012
71731575|NCT00870194|142977849|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.4%|Least Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.012|TWO_SIDED|95.0|0.07|0.53|||Mixed Model Repeated Measures||Standard Error of the Least Square Mean|Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.||0.53|0.07|.012
71731576|NCT00870194|142977850|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Fisher's Exact Test|||||||.038
71731577|NCT00870194|142977851|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher's Exact Test|||||||.027
71731578|NCT00870194|142977852|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher's Exact Test|||||||.480
71731579|NCT00870194|142977853|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||.038
71731580|NCT00870194|142977854|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Mixed Model Repeated Measures|||||||.266
71731581|NCT00870194|142977855|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Mixed Model Repeated Measures|||||||.095
71731582|NCT00870194|142977856|SUPERIORITY_OR_OTHER|||||||0.567||95.0|||||Mixed Model Repeated Measures|||||||.567
71731583|NCT00870194|142977857|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||Mixed Model Repeated Measures|||||||.207
71731584|NCT00870194|142977858|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||||||.055
71731585|NCT00870194|142977859|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANCOVA|||||||.269
71731586|NCT00870194|142977860|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||ANCOVA|||||||.622
71731587|NCT00870194|142977861|SUPERIORITY_OR_OTHER|||||||0.888||95.0|||||ANCOVA|||||||.888
71731588|NCT00870194|142977862|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Fisher's Exact Test|||||||.287
71731589|NCT00870194|142977863|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Fisher's Exact Test|||||||.498
71731590|NCT00870194|142977864|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Fisher's Exact Test|||||||.247
71731591|NCT00870194|142977865|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher's Exact Test|||||||1.00
71739114|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||0.040
71739115|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 months||||0.033
71739116|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.500
71739117|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.750
71739118|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.156
71739119|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months||||0.938
71739120|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months||||0.250
71739121|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months||||0.999
71739122|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.057
71739123|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.031
71739124|NCT01846741|142991053|SUPERIORITY_OR_OTHER|||||||0.625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months||||0.625
71739125|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0008
71739126|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0544|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure Score||||0.0544
71739127|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0207|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0207
71888958|NCT02939131|143298800|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.|Mean Difference (Final Values)|2.57||||0.6|TWO_SIDED|95.0|-7.85|12.98|||t-test, 2 sided||We subtracted the group mean for the ESC group from that of the COMB-R group. The group mean is the mean of the site-specific percentages of participants with events.|This is the analysis of new Grade 3+ diagnoses through week 24.The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||12.98|-7.85|0.60
71888959|NCT02939131|143298800|SUPERIORITY|We tested the null hypothesis that the treatment group means were equal vs. not.The group mean is the mean of the site-specific percentages of participants with events as defined above.|Mean Difference (Final Values)|4.4||||0.17|TWO_SIDED|95.0|-2.21|11.02|||t-test, 2 sided||The ESC group mean percent of participants reporting a trigger event was subtracted from the COMB-R group mean.|This is the analysis of the triggering events (psychiatric hospitalizations or suicide attempts) through week 24. A participant is counted once if they had reported any such event prior to the upper bound of the week 24 window. The percent of participants at each site with at least one such event were computed.The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.02|-2.21|0.17
71888960|NCT02939131|143298801|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.98|TWO_SIDED|95.0|-13.85|14.13|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ signs/symptoms through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||14.13|-13.85|0.98
71888961|NCT02939131|143298801|SUPERIORITY||Mean Difference (Final Values)|5.64||||0.4|TWO_SIDED|95.0|-8.6|19.89|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new Grade 3+ diagnoses through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||19.89|-8.60|0.40
71888962|NCT02939131|143298801|SUPERIORITY||Mean Difference (Final Values)|3.01||||0.44|TWO_SIDED|95.0|-5.27|11.29|||t-test, 2 sided||A positive difference indicates more participants with events in the COMB-R group.|This is the analysis of new trigger events through week 48. The percent of participants at each site with at least one such event was computed. The average of these site-level percents was calculated for each treatment arm. These averages were compared.||11.29|-5.27|0.44
71888963|NCT00988247|143298835|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.97|||<|0.001|TWO_SIDED|95.0|-1.5|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.5|<0.001
71888964|NCT00988247|143298836|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-0.96|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.5|-1.4|<0.001
71661200|NCT00123474|142836030|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-8.9|8.5||||||||8.5|-8.9|
71731592|NCT01443130|142977891|SUPERIORITY_OR_OTHER|||||||0.2441||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2441
71731593|NCT01443130|142977891|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
71772251|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.369|||<|0.001|TWO_SIDED|95.0|0.229|0.51||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 16 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.510|0.229|<0.001
71772252|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.363|||<|0.001|TWO_SIDED|95.0|0.23|0.496||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 18 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.496|0.230|<0.001
71661201|NCT00123474|142836041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-11.7|15.3||||||6 Month Analysis||15.3|-11.7|
71772253|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.284|||<|0.001|TWO_SIDED|95.0|0.154|0.414||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 20 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.414|0.154|<0.001
71772254|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.197|||=|0.003|TWO_SIDED|95.0|0.065|0.329||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 22 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.329|0.065|=0.003
71772255|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.187|||=|0.004|TWO_SIDED|95.0|0.059|0.316||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 24 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.316|0.059|=0.004
71772256|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.243|||<|0.001|TWO_SIDED|95.0|0.113|0.373||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 26 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.373|0.113|<0.001
71772257|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.207|||=|0.002|TWO_SIDED|95.0|0.074|0.34||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 28 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.340|0.074|=0.002
71772258|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.227|||<|0.001|TWO_SIDED|95.0|0.096|0.358||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 30 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.358|0.096|<0.001
71772259|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.199|||=|0.004|TWO_SIDED|95.0|0.064|0.334|||Mixed Models Analysis|p-value for superiority test based on 2-sided significance level.||Week 32 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.334|0.064|=0.004
71772260|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.279|||<|0.001||95.0|0.15|0.409||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 34 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.409|0.150|<0.001
71772261|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.256|||<|0.001|TWO_SIDED|95.0|0.121|0.391||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 36- The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.391|0.121|<0.001
71772262|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.136|||=|0.06|TWO_SIDED|95.0|-0.006|0.277||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 40 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.277|-0.006|=0.060
71772263|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.082|||=|0.293|TWO_SIDED|95.0|-0.071|0.236||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 44 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.236|-0.071|=0.293
71772264|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.027|||=|0.723|TWO_SIDED|95.0|-0.123|0.177||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 48 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.177|-0.123|=0.723
71772265|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.199|||=|0.009|TWO_SIDED|95.0|0.049|0.348||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 52 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.348|0.049|=0.009
71831398|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|2.62||0.2448|TWO_SIDED|95.0|-2.1|8.2|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||8.20|-2.10|0.2448
71831399|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|4.96|STANDARD_ERROR_OF_MEAN|2.58||0.0551|TWO_SIDED|95.0|-0.11|10.04|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||10.04|-0.11|0.0551
71772266|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.147|||=|0.056|TWO_SIDED|95.0|-0.004|0.298||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 56 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.298|-0.004|=0.056
71772267|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.196|||=|0.01|TWO_SIDED|95.0|0.047|0.346||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 60 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.346|0.047|=0.010
71772268|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.275|||<|0.001|TWO_SIDED|95.0|0.123|0.427||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 64 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.427|0.123|<0.001
71772269|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.206|||=|0.006|TWO_SIDED|95.0|0.059|0.353||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 68 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.353|0.059|=0.006
71772270|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.118|||=|0.127|TWO_SIDED|95.0|-0.033|0.269||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 72 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.269|-0.033|=0.127
71658928|NCT03276221|142833413|SUPERIORITY||Slope|-10.86|STANDARD_ERROR_OF_MEAN|5.24||0.038|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the stop signal task module. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the inhibition latency for the abstinence group above and beyond the monitoring group (positive values indicate slower inhibition for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.038
71658929|NCT03276221|142833414|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.576|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of making an error for the abstinence group above and beyond the monitoring group (positive values indicate higher error commission for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.576
71658930|NCT03276221|142833415|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.296|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the spatial working memory module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the log probability of trials with strategic responding for the abstinence group above and beyond the monitoring group (positive values indicate higher rates of strategic responding for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.296
71661202|NCT00123474|142836041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-9.3|17.6||||||6 Month Analysis||17.6|-9.3|
71731594|NCT01443130|142977892|SUPERIORITY_OR_OTHER|||||||0.4941||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4941
71731595|NCT01443130|142977892|SUPERIORITY_OR_OTHER|||||||0.499||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4990
71731596|NCT01443130|142977893|SUPERIORITY_OR_OTHER|||||||0.3089||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3089
71731597|NCT01443130|142977893|SUPERIORITY_OR_OTHER|||||||0.6973||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.6973
71731598|NCT01443130|142977894|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||1.00
71731599|NCT01443130|142977894|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.00
71731600|NCT01443130|142977895|SUPERIORITY_OR_OTHER|||||||0.4979||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4979
71739128|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0163|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0163
71739129|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0156
71739130|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0742
71739131|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0884|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0884
71739132|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0007
71888965|NCT00988247|143298837|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.09|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
71731601|NCT01443130|142977895|SUPERIORITY_OR_OTHER|||||||0.1166||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1166
71731602|NCT01443130|142977896|SUPERIORITY_OR_OTHER|||||||0.6237||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.6237
71731603|NCT01443130|142977896|SUPERIORITY_OR_OTHER|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||1.000
71731604|NCT01443130|142977897|SUPERIORITY_OR_OTHER|||||||0.5187||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5187
71731605|NCT01443130|142977897|SUPERIORITY_OR_OTHER|||||||0.2163||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.2163
71772271|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.211|||=|0.01|TWO_SIDED|95.0|0.051|0.371||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 76 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.371|0.051|=0.010
71772272|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.102|||=|0.191|TWO_SIDED|95.0|-0.051|0.255||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 80 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.255|-0.051|=0.191
71772273|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.192|||=|0.018|TWO_SIDED|95.0|0.033|0.351||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 84 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.351|0.033|=0.018
71772274|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.044|||=|0.576|TWO_SIDED|95.0|-0.111|0.2||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 88 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.200|-0.111|=0.576
71831400|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|1.05||0.247|TWO_SIDED|95.0|-3.26|0.84|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.84|-3.26|0.2470
71831401|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-1.98|STANDARD_ERROR_OF_MEAN|1.04||0.057|TWO_SIDED|95.0|-4.01|0.06|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.06|-4.01|0.0570
71831402|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.917|TWO_SIDED|95.0|-2.36|2.12|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.12|-2.36|0.9170
71888966|NCT00988247|143298838|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo]|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.||||-0.6|-1.6|<0.001
71772275|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.203|||=|0.017|TWO_SIDED|95.0|0.037|0.369||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 92 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.369|0.037|=0.017
71888967|NCT00988247|143298839|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.3||||0.143|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-0.7|0.143
71731606|NCT01443130|142977898|SUPERIORITY_OR_OTHER|||||||0.5959||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.5959
71731607|NCT01443130|142977898|SUPERIORITY_OR_OTHER|||||||0.8127||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.8127
71731608|NCT01443130|142977899|SUPERIORITY_OR_OTHER|||||||0.2566||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2566
71731609|NCT01443130|142977899|SUPERIORITY_OR_OTHER|||||||0.7839||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.7839
71731610|NCT01443130|142977900|SUPERIORITY_OR_OTHER|||||||0.2553||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.2553
71731611|NCT01443130|142977900|SUPERIORITY_OR_OTHER|||||||0.4354||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4354
71888968|NCT00988247|143298840|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.49||||0.13|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.||||0.1|-1.1|0.130
71888969|NCT01169779|143298850|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.0004|TWO_SIDED|95.0|-0.551|-0.162||Statistical testing:2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), sulfonylurea use (Yes,No), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change in HbA1c at Week 24 between lixisenatide arm and placebo arm, 190 patients per group would provide a power of 96% assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.||-0.162|-0.551|0.0004
71888970|NCT00542620|143298860|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Median Difference (Final Values)|-0.691||||0.001||95.0|-1.049|-0.334||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated|ANCOVA|Baseline HbA1c as covariate||||-0.334|-1.049|0.001
71888971|NCT00542620|143298861|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D\>0.25% against HA: D=\<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Mean Difference (Final Values)|-0.594||||0.003||95.0|-0.97|-0.219||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.|ANCOVA|Baseline HbA1c as covariate.||||-0.219|-0.970|0.003
71888972|NCT00542620|143298862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|14.59||0.573||95.0|-38.77|22.08|||ANCOVA|With adjustment on baseline fructosamine and the change in insulin administration mode||||22.08|-38.77|0.573
71888973|NCT00542620|143298863|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANCOVA|With adjustment on baseline value||||||0.063
71888974|NCT00542620|143298864|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|With adjustment on baseline value||||||0.389
71888975|NCT00542620|143298865|SUPERIORITY_OR_OTHER|||||||0.856|||||||ANCOVA|With adjustment on baseline value||||||0.856
71888976|NCT00542620|143298866|SUPERIORITY_OR_OTHER|||||||0.917|||||||ANCOVA|With adjustment on baseline value||||||0.917
71888977|NCT00542620|143298867|SUPERIORITY_OR_OTHER|||||||0.209|||||||ANCOVA|With adjustment on baseline value||||||0.209
71888978|NCT00542620|143298868|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANCOVA|With adjustment on baseline value||||||0.220
71888979|NCT00542620|143298869|SUPERIORITY_OR_OTHER|||||||0.234|||||||ANCOVA|With adjustment for baseline value||||||0.234
71888980|NCT00542620|143298870|SUPERIORITY_OR_OTHER|||||||0.534|||||||ANCOVA|With adjustment on baseline value||||||0.534
71888981|NCT00542620|143298871|SUPERIORITY_OR_OTHER|||||||0.722|||||||ANCOVA|With adjustment on baseline value||||||0.722
71888982|NCT00542620|143298872|SUPERIORITY_OR_OTHER|||||||0.727|||||||ANCOVA|With adjustment on baseline value||||||0.727
71888983|NCT00542620|143298873|SUPERIORITY_OR_OTHER|||||||0.411|||||||ANCOVA|With adjustment on baseline value||||||0.411
71731612|NCT01443130|142977901|SUPERIORITY_OR_OTHER|||||||0.369||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.3690
71888984|NCT00542620|143298874|SUPERIORITY_OR_OTHER|||||||0.471|||||||ANCOVA|With adjustment on baseline value||||||0.471
71888985|NCT00542620|143298877|SUPERIORITY_OR_OTHER|||||||0.127|||||||ANCOVA|With adjustment on baseline value||||||0.127
71888986|NCT00542620|143298878|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|With adjustment on baseline value||||||0.1
71888987|NCT00542620|143298879|SUPERIORITY_OR_OTHER|||||||0.166|||||||ANCOVA|With adjustment on baseline value||||||0.166
71888988|NCT00542620|143298880|SUPERIORITY_OR_OTHER|||||||0.023|||||||ANCOVA|With adjustment on baseline value||||||0.023
71888989|NCT00542620|143298881|SUPERIORITY_OR_OTHER|||||||0.439|||||||ANCOVA|With adjustment on baseline value||||||0.439
71888990|NCT00542620|143298882|SUPERIORITY_OR_OTHER|||||||0.202|||||||ANCOVA|With adjustment on baseline value||||||0.202
71888991|NCT00542620|143298883|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|With adjustment on baseline value||||||0.665
71888992|NCT00956930|143298890|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.122||||0.007|TWO_SIDED|95.0|0.027|0.557|||Log Rank|||||0.557|0.027|0.007
71888993|NCT00849667|143298928|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4513|TWO_SIDED|95.0|0.81|1.21|||Log Rank|One-sided log rank test||||1.21|0.81|0.4513
71888994|NCT00849667|143298928|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0761|TWO_SIDED|95.0|0.7|1.06|||Log Rank|One-sided log rank test||||1.06|0.70|0.0761
71888995|NCT00849667|143298929|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4823|TWO_SIDED|95.0|0.78|1.27|||Log Rank|One-sided log rank test||||1.27|0.78|0.4823
71888996|NCT00849667|143298929|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1616|TWO_SIDED|95.0|0.68|1.13|||Log Rank|One-sided log rank test||||1.13|0.68|0.1616
71888997|NCT00849667|143298930|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.2938|TWO_SIDED|95.0|0.72|1.21|||Log Rank|One-sided log-rank test||||1.21|0.72|0.2938
71772276|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.184|||=|0.019|TWO_SIDED|95.0|0.031|0.338||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 96 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.338|0.031|=0.019
71658931|NCT03276221|142833416|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.65|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the discriminability measure for the abstinence group above and beyond the monitoring group (positive values indicate higher discriminability rates for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.650
71658932|NCT03276221|142833417|SUPERIORITY||Slope|-11.64|STANDARD_ERROR_OF_MEAN|9.55||0.223|TWO_SIDED|||||The p-value was adjusted for multiple comparisons by the Bonferroni correction across outcomes for the rapid visual information processing module. The a priori threshold for statistical significance was 0.025.|Mixed Models Analysis|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|The estimate is the mean difference in the median response latency for the abstinence group above and beyond the monitoring group (positive values indicate slower responses for the abstinence group).|The mean difference in scale scores between the abstinence and monitoring groups was estimated via a binomial model with a dummy-coded contrast (0 for monitoring, 1 for abstinence). The model adjusted for change at weeks 2, 3, and 4 of the study, and for a subject's scale scores at baseline.||||0.223
71658933|NCT02912650|142833418|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.08|||<|0.001|TWO_SIDED|95.0|24.14|36.02|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.||36.02|24.14|<0.001
71772277|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.164|||=|0.056||95.0|-0.004|0.333||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 100 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.333|-0.004|=0.056
71772278|NCT02278341|143044757|SUPERIORITY||LSM Difference|0.099|||=|0.267|TWO_SIDED|95.0|-0.076|0.273||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Week 104 - The model included treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline Hb as continuous covariates.||0.273|-0.076|=0.267
71658934|NCT02912650|142833418|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.008|TWO_SIDED|95.0|1.51|9.8|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||9.80|1.51|0.008
71658935|NCT02912650|142833418|SUPERIORITY_OR_OTHER||LS Mean Difference|14.76|||<|0.001|TWO_SIDED|95.0|10.55|18.97|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||18.97|10.55|<0.001
71658936|NCT02912650|142833418|SUPERIORITY_OR_OTHER||LS Mean Difference|24.42|||<|0.001|TWO_SIDED|95.0|18.5|30.35|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||30.35|18.50|<0.001
71658937|NCT02912650|142833418|SUPERIORITY_OR_OTHER||LS Mean Difference|15.32|||<|0.001|TWO_SIDED|95.0|9.35|21.29|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||21.29|9.35|<0.001
71658938|NCT02912650|142833418|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1|||<|0.001|TWO_SIDED|95.0|4.9|13.31|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||13.31|4.90|<0.001
71658939|NCT02912650|142833419|SUPERIORITY_OR_OTHER||LS Mean Difference|9.26|||<|0.001|TWO_SIDED|95.0|6.59|11.94|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.94|6.59|<0.001
71658940|NCT02912650|142833419|SUPERIORITY_OR_OTHER||LS Mean Difference|1.84||||0.053|TWO_SIDED|95.0|-0.03|3.71|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.71|-0.03|0.053
71658941|NCT02912650|142833419|SUPERIORITY_OR_OTHER||LS Mean Difference|5.59|||<|0.001|TWO_SIDED|95.0|3.69|7.49|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.49|3.69|<0.001
71658942|NCT02912650|142833419|SUPERIORITY_OR_OTHER||LS Mean Difference|7.42|||<|0.001|TWO_SIDED|95.0|4.75|10.09|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.09|4.75|<0.001
71658943|NCT02912650|142833419|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67||||0.008|TWO_SIDED|95.0|0.98|6.36|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.36|0.98|0.008
71772279|NCT02278341|143044758|SUPERIORITY||LSM Difference|0.237|||<|0.001|TWO_SIDED|95.0|0.127|0.347||p-value for superiority test based on 2-sided significance level.|Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.347|0.127|<0.001
71772280|NCT02278341|143044758|SUPERIORITY||LSM Difference|0.105|||=|0.086|TWO_SIDED|95.0|-0.015|0.225||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.225|-0.015|=0.086
71772281|NCT02278341|143044758|SUPERIORITY||LSM Difference|0.149|||=|0.031|TWO_SIDED|95.0|0.014|0.284||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.284|0.014|=0.031
71772282|NCT02278341|143044759|SUPERIORITY||LSM Difference|0.235|||<|0.001|TWO_SIDED|95.0|0.125|0.346|||Mixed Models Analysis|||Weeks 28-36 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.346|0.125|<0.001
71772283|NCT02278341|143044759|SUPERIORITY||LSM Difference|0.104|||=|0.11|TWO_SIDED|95.0|-0.024|0.232|||Mixed Models Analysis|||Weeks 44-52 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.232|-0.024|=0.110
71772284|NCT02278341|143044759|SUPERIORITY||LSM Difference|0.149|||=|0.036|TWO_SIDED|95.0|0.01|0.288|||Mixed Models Analysis|||Weeks 96-104 - The model includes treatment arm, region, CV History, previous ESA treatment, visits and visit by treatment as categorical variables and baseline Hb as continuous variable.||0.288|0.010|=0.036
71772285|NCT02278341|143044764|SUPERIORITY||Hazard Ratio (HR)|1.154|||=|0.164|TWO_SIDED|95.0|0.943|1.411||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.411|0.943|=0.164
71772286|NCT02278341|143044765|SUPERIORITY||Hazard Ratio (HR)|0.979|||=|0.917|TWO_SIDED|95.0|0.656|1.462|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.462|0.656|=0.917
71772287|NCT02278341|143044766|SUPERIORITY||Hazard Ratio (HR)|0.867|||=|0.501|TWO_SIDED|95.0|0.573|1.313||p-value for superiority test based on 2-sided significance level|Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment, and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||1.313|0.573|=0.501
71772288|NCT02278341|143044767|SUPERIORITY||LSM Difference|-0.006|||=|0.507|TWO_SIDED|95.0|-0.02|0.01||p-value for superiority test based on 2-sided significance level|ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||0.01|-0.02|=0.507
71772289|NCT02278341|143044768|SUPERIORITY||LSM Difference|0.132|||=|0.949|TWO_SIDED|95.0|-3.9|4.16|||ANCOVA|||The model included treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||4.16|-3.90|=0.949
71772290|NCT02278341|143044769|SUPERIORITY||Hazard Ratio (HR)|0.368|||<|0.001|TWO_SIDED|95.0|0.291|0.465|||Regression, Cox|||Hazard Ratio was calculated using stratified Cox Proportional Hazards regression stratifying on region, CV history, previous ESA treatment and adjusting on Hb at baseline as continuous covariate. Superiority was declared if the upper bound of the 95% CI was below 1.0.||0.465|0.291|<0.001
71772291|NCT02278341|143044770|SUPERIORITY||LSM Difference|-35.1|||<|0.001|TWO_SIDED|95.0|-51.8|-18.4|||ANCOVA|||Weeks 37-52 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-18.4|-51.8|<0.001
71831403|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.14||0.4991|TWO_SIDED|95.0|-3.0|1.46|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.46|-3.00|0.4991
71831404|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.44||0.2377|TWO_SIDED|95.0|-1.12|4.52|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.52|-1.12|0.2377
71888998|NCT00849667|143298930|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0318|TWO_SIDED|95.0|0.58|1.02|||Log Rank|One-sided log-rank test||||1.02|0.58|0.0318
71888999|NCT00849667|143298931|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5636|TWO_SIDED|95.0|0.85|1.21|||Log Rank|One-sided log-rank test||||1.21|0.85|0.5636
71772292|NCT02278341|143044770|SUPERIORITY||LSM Difference|-48.7|||<|0.001|TWO_SIDED|95.0|-70.3|-27.0|||ANCOVA|||Weeks 53-104 - Participants with no or missing medication records of IV Iron had their monthly IV Iron use set to 0 mg. The model includes treatment arm, region, CV History, previous ESA treatment as categorical variables and baseline Hb as continuous variable.||-27.0|-70.3|<0.001
71772293|NCT02278341|143044780|SUPERIORITY||LSM Difference|0.521|||=|0.161|TWO_SIDED|95.0|-0.208|1.25||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline SF-36 PCS, baseline Hb, as continuous covariates.||1.250|-0.208|=0.161
71772294|NCT02278341|143044781|SUPERIORITY||LSM Difference|0.126|||=|0.845|TWO_SIDED|95.0|-1.135|1.387||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||1.387|-1.135|=0.845
71889000|NCT00849667|143298931|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.156|TWO_SIDED|95.0|0.76|1.09|||Log Rank|One-sided log-rank test||||1.09|0.76|0.1560
71889001|NCT00849667|143298933|SUPERIORITY||Difference in percentage|1.8||||0.6864|TWO_SIDED|95.0|-5.4|9.0|||Cochran-Mantel-Haenszel|||||9.0|-5.4|0.6864
71889002|NCT00849667|143298933|SUPERIORITY||Difference in percentage|2.4||||0.4923|TWO_SIDED|95.0|-4.8|9.6|||Cochran-Mantel-Haenszel|||||9.6|-4.8|0.4923
71831405|NCT02528188|143167444|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.44||0.0238|TWO_SIDED|95.0|0.43|6.08|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||6.08|0.43|0.0238
71889003|NCT00849667|143298936|SUPERIORITY||Difference in percentage|-0.4||||0.8106|TWO_SIDED|95.0|-4.9|4.1|||Cochran-Mantel-Haenszel|||50% serological response||4.1|-4.9|0.8106
71731613|NCT01443130|142977901|SUPERIORITY_OR_OTHER|||||||0.4947||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4947
71731614|NCT01443130|142977902|SUPERIORITY_OR_OTHER|||||||0.063||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0630
71731615|NCT01443130|142977902|SUPERIORITY_OR_OTHER|||||||0.4184||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.4184
71731616|NCT01443130|142977903|SUPERIORITY_OR_OTHER|||||||0.0268||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.0268
71731617|NCT01443130|142977903|SUPERIORITY_OR_OTHER|||||||0.1646||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1646
71731618|NCT01443130|142977904|SUPERIORITY_OR_OTHER|||||||0.4501||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.||||0.4501
71731619|NCT01443130|142977904|SUPERIORITY_OR_OTHER|||||||0.1758||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.||||0.1758
71731620|NCT03461406|142977912|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Parenchymous)||1.09|0.92|< 0.001
71731621|NCT03461406|142977912|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8|Relative risk|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.16|||Cochran-Mantel-Haenszel|||Hemostasis by 4 Minutes (Soft Tissue)||1.16|0.91|< 0.001
71731622|NCT03461406|142977913|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Parenchymous)||1.09|0.92|< 0.001
71731623|NCT03461406|142977913|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% confidence interval (CI) exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 7 Minutes (Soft tissue)||1.09|0.92|< 0.001
71731624|NCT03461406|142977914|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|0.98|||<|0.001|TWO_SIDED|95.0|0.94|1.02|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Parenchymous)||1.02|0.94|< 0.001
71731625|NCT03461406|142977914|NON_INFERIORITY|The non-inferiority was deemed to have been demonstrated if the lower limit of the 95% CI exceeds 0.8.|Relative risk|1.0|||<|0.001|TWO_SIDED|95.0|0.92|1.09|||Cochran-Mantel-Haenszel|||Hemostasis by 10 Minutes (Soft tissue)||1.09|0.92|< 0.001
71731626|NCT00973102|142977922|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.47||||0.252|TWO_SIDED|95.0|1.16|5.25|||Barnard's unconditional Exact Test|||||5.25|1.16|.252
71731627|NCT00973102|142977923|SUPERIORITY_OR_OTHER_LEGACY|||||||0.895|||||||t-test, 2 sided|||||||.895
71731628|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||||90.0|-3.8|1.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.59|-3.80|
71731629|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||||90.0|-3.55|-0.31|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.31|-3.55|
71739133|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.1173
71831406|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.08||0.0142|TWO_SIDED|95.0|0.53|4.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.78|0.53|0.0142
71658944|NCT02912650|142833419|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.85|5.64|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|1.85|<0.001
71658945|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|13.05|||<|0.001|TWO_SIDED|95.0|10.39|15.71|||ANOVA|||0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.||15.71|10.39|<0.001
71658946|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|3.01||||0.002|TWO_SIDED|95.0|1.15|4.86|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.86|1.15|0.002
71731630|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||||90.0|-7.69|-2.3|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.30|-7.69|
71731631|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-4.58|-1.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.34|-4.58|
71731632|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88||||||90.0|-7.58|-2.19|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.19|-7.58|
71731633|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82||||||90.0|-5.44|-2.2|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-2.20|-5.44|
71731634|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-4.74|0.64|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.64|-4.74|
71731635|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.76||||||90.0|-3.38|-0.15|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.15|-3.38|
71731636|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||||90.0|-4.77|0.62|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.62|-4.77|
71731637|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||||90.0|-2.49|0.74|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.74|-2.49|
71739134|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0214
71739135|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0114
71739136|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0078
71739137|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0875|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0875
71739138|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.1526|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.1526
71739139|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0031
71739140|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure||||0.0828
71889004|NCT00849667|143298936|SUPERIORITY||Difference in percentage|5.1||||0.0064|TWO_SIDED|95.0|1.4|8.8|||Cochran-Mantel-Haenszel|||50% serological response||8.8|1.4|0.0064
71658947|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|6.94|||<|0.001|TWO_SIDED|95.0|5.06|8.83|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.83|5.06|<0.001
71772295|NCT02278341|143044782|SUPERIORITY||LSM Difference|-0.128|||=|0.922|TWO_SIDED|95.0|-2.703|2.447||p-value for superiority test based on 2-sided significance level|Mixed Models Analysis|||The model includes treatment, visit, visit by treatment interaction, Previous ESA Treatment, region and history of CV disease as fixed class factors and baseline FACT-An Ans, baseline Hb, as continuous covariates.||2.447|-2.703|=0.922
71658948|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|10.05|||<|0.001|TWO_SIDED|95.0|7.39|12.7|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.70|7.39|<0.001
71658949|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|6.11|||<|0.001|TWO_SIDED|95.0|3.44|8.78|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.78|3.44|<0.001
71658950|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|3.94|||<|0.001|TWO_SIDED|95.0|2.06|5.81|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.81|2.06|<0.001
71658951|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|3.84|||<|0.001|TWO_SIDED|95.0|2.63|5.05|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.05|2.63|<0.001
71658952|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.013|TWO_SIDED|95.0|0.23|1.92|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.23|0.013
71658953|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|1.83|3.55|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.55|1.83|<0.001
71658954|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.56|3.98|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.98|1.56|<0.001
71658955|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.064|TWO_SIDED|95.0|-0.07|2.37|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.37|-0.07|0.064
71658956|NCT02912650|142833420|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62|||<|0.001|TWO_SIDED|95.0|0.76|2.47|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|0.76|<0.001
71658957|NCT02912650|142833421|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658958|NCT02912650|142833421|SUPERIORITY_OR_OTHER|||||||0.069|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.069
71658959|NCT02912650|142833421|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658960|NCT02912650|142833421|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658961|NCT02912650|142833421|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658962|NCT02912650|142833421|SUPERIORITY_OR_OTHER|||||||0.005|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.005
71731638|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-4.99|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-4.99|
71731639|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||||90.0|-2.47|0.77|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.77|-2.47|
71731640|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22||||||90.0|-6.91|-1.52|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.52|-6.91|
71831407|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|2.56|6.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||6.78|2.56|<0.0001
71658963|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
71658964|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
71731641|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51||||||90.0|-4.13|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-4.13|
71731642|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||||90.0|-4.63|0.76|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.76|-4.63|
71731643|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32||||||90.0|-3.94|-0.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.70|-3.94|
71731644|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.36||||||90.0|-8.22|-0.5|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.50|-8.22|
71731645|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||||90.0|-6.29|-1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.56|-6.29|
71731646|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||||90.0|-10.77|-3.05|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.05|-10.77|
71731647|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79||||||90.0|-8.15|-3.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-3.42|-8.15|
71731648|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8||||||90.0|-9.66|-1.94|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.94|-9.66|
71731649|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.65||||||90.0|-9.01|-4.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-4.29|-9.01|
71731650|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.27||||||90.0|-8.13|-0.41|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.41|-8.13|
71731651|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||||90.0|-6.01|-1.29|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.29|-6.01|
71731652|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||||90.0|-5.91|1.81|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.81|-5.91|
71731653|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||||90.0|-3.46|1.27|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.27|-3.46|
71772296|NCT02604017|143044790|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.|Percentage of Participants|99.7|||||TWO_SIDED|95.0|99.1|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides \>90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|99.1|
71772297|NCT02604017|143044791|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||1.1|-1.1|
71772298|NCT02604017|143044792|NON_INFERIORITY|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|-0.6|||||TWO_SIDED|95.0|-1.8|0.6||||||Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides \>90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.||0.6|-1.8|
71772299|NCT02821910|143044807|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.7|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|92.89|100.66|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.66|92.89|
71772300|NCT02821910|143044807|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.8|STANDARD_DEVIATION|4.8|||TWO_SIDED|90.0|97.99|103.7|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.70|97.99|
71772301|NCT02821910|143044807|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.83|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|95.96|103.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.85|95.96|
71772302|NCT02821910|143044808|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.82|STANDARD_DEVIATION|9.7|||TWO_SIDED|90.0|90.65|103.42|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.42|90.65|
71772303|NCT02821910|143044808|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.67|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.44|104.68|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.68|87.44|
71772304|NCT02821910|143044808|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.47|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|92.12|105.25|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.25|92.12|
71831408|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.45||0.1371|TWO_SIDED|95.0|-0.69|4.99|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.99|-0.69|0.1371
71658965|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||ANOVA|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
71831409|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.46||0.8524|TWO_SIDED|95.0|-2.6|3.14|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.14|-2.60|0.8524
71831410|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|3.8||0.5253|TWO_SIDED|95.0|-9.93|5.09|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.09|-9.93|0.5253
71831411|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|3.71||0.5381|TWO_SIDED|95.0|-5.04|9.62|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||9.62|-5.04|0.5381
71831412|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|7.27|STANDARD_ERROR_OF_MEAN|6.44||0.2694|TWO_SIDED|95.0|-5.99|20.54|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||20.54|-5.99|0.2694
71731654|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||||90.0|-6.16|1.56|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||1.56|-6.16|
71889005|NCT00849667|143298936|SUPERIORITY||Difference in percentage|4.1||||0.3005|TWO_SIDED|95.0|-2.0|10.2|||Cochran-Mantel-Haenszel|||75% serological response||10.2|-2.0|0.3005
71889006|NCT00849667|143298936|SUPERIORITY||Difference in percentage|3.7||||0.2445|TWO_SIDED|95.0|-2.5|9.9|||Cochran-Mantel-Haenszel|||75% serological response||9.9|-2.5|0.2445
71731655|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||||90.0|-5.79|-1.06|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-1.06|-5.79|
71731656|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||||90.0|-7.33|0.39|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.39|-7.33|
71731657|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.26||||||90.0|-5.62|-0.9|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||-0.90|-5.62|
71731658|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||||90.0|-4.13|3.59|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||3.59|-4.13|
71739141|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0092|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery||||0.0092
71831413|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|-9.34|STANDARD_ERROR_OF_MEAN|6.05||0.1349|TWO_SIDED|95.0|-21.8|3.11|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.11|-21.80|0.1349
71831414|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.0264|TWO_SIDED|95.0|0.21|3.38|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.38|0.21|0.0264
71831415|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.8||0.0098|TWO_SIDED|95.0|0.5|3.65|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.65|0.50|0.0098
71889007|NCT00849667|143298936|SUPERIORITY||Difference in percentage|5.3||||0.2797|TWO_SIDED|95.0|-2.8|13.4|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.4|-2.8|0.2797
71889008|NCT00849667|143298936|SUPERIORITY||Difference in percentage|4.9||||0.2136|TWO_SIDED|95.0|-3.2|13.0|||Cochran-Mantel-Haenszel|||Serologic response leading to normalization||13.0|-3.2|0.2136
71889009|NCT01262625|143298947|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|the pre-defined non-inferiority margin of 1.25|Hazard Ratio (HR)|1.03||||0.19|TWO_SIDED|95.0|0.61|1.75|||Regression, Cox|||||1.75|0.61|0.19
71889010|NCT01262625|143298948|SUPERIORITY|||||||0.08|||||||DeLong|(DeLong et al 1988)||||||0.08
71889011|NCT01262625|143298948|SUPERIORITY|||||||0.02|||||||DeLong|(DeLong et al 1988)||||||0.02
71731659|NCT00853840|142977924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26||||||90.0|-4.62|0.1|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."||0.10|-4.62|
71731660|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95||||||90.0|4.18|9.72|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||9.72|4.18|
71731661|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51||||||90.0|2.73|8.28|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.28|2.73|
71731662|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.64||||||90.0|0.87|6.42|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.42|0.87|
71731663|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||||90.0|0.12|5.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||5.67|0.12|
71731664|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||||90.0|-0.71|4.83|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||4.83|-0.71|
71731665|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||||90.0|2.68|8.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||8.22|2.68|
71731666|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||||90.0|1.34|6.89|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.89|1.34|
71731667|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.45||||||90.0|0.68|6.22|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for supine pulse rate~Vardenafil minus Placebo"||6.22|0.68|
71731668|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33||||||90.0|3.7|10.95|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"1.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.95|3.70|
71731669|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|3.2|10.45|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||10.45|3.20|
71731670|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.02||||||90.0|1.4|8.65|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"2.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.65|1.40|
71731671|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.72||||||90.0|1.09|8.34|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"3 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.34|1.09|
71772305|NCT02821910|143044809|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|94.94|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|86.6|104.08|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.08|86.60|
71772306|NCT02821910|143044809|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|106.63|STANDARD_DEVIATION|9.9|||TWO_SIDED|90.0|100.65|112.96|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.96|100.65|
71772307|NCT02821910|143044809|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.41|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|94.54|106.64|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.64|94.54|
71772308|NCT02821910|143044810|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.97|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|91.46|104.94|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.94|91.46|
71731672|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05||||||90.0|0.43|7.67|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"4 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||7.67|0.43|
71731673|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||||90.0|2.73|9.98|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"6 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||9.98|2.73|
71731674|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.08||||||90.0|1.45|8.7|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"8 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||8.70|1.45|
71731675|NCT00853840|142977925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||||90.0|-1.74|5.51|||Mixed Models Analysis|Sequence, period, time, treatment, \& time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.||"12 hour post-dose for standing pulse rate~Vardenafil minus Placebo"||5.51|-1.74|
71731676|NCT02008357|142977944|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.26|TWO_SIDED|95.0|-0.816|0.22|||Natural Cubic Spline (NCS) method|||||0.220|-0.816|0.260
71731677|NCT02008357|142977946|SUPERIORITY||LS Mean difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.28||0.1|TWO_SIDED|95.0|-0.089|1.02|||Natural Cubic Spline (NCS) method|||||1.020|-0.089|0.100
71731678|NCT02008357|142977948|SUPERIORITY||LS Mean difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34||0.082|TWO_SIDED|95.0|-1.265|0.076|||Natural Cubic Spline (NCS) method|||||0.076|-1.265|0.082
71731679|NCT02008357|142977950|SUPERIORITY||LS Mean difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0073|<|0.001|TWO_SIDED|95.0|-0.057|-0.028|||ANCOVA|||||-0.028|-0.057|<0.001
71731680|NCT02008357|142977951|SUPERIORITY||LS Mean difference (Final Values)|3.239|STANDARD_ERROR_OF_MEAN|32.8719||0.922|TWO_SIDED|95.0|-62.02|68.498|||ANCOVA|||Cerebrospinal fluid Tau Protein Immunoassay||68.498|-62.020|0.922
71731681|NCT02008357|142977951|SUPERIORITY||LS Mean difference (Final Values)|-0.965|STANDARD_ERROR_OF_MEAN|2.6535||0.717|TWO_SIDED|95.0|-6.241|4.311|||ANCOVA|||Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay||4.311|-6.241|0.717
71731682|NCT02008357|142977952|SUPERIORITY||LS Mean difference (Final Values)|12738.449|STANDARD_ERROR_OF_MEAN|998.7048|<|0.001|TWO_SIDED|95.0|10757.047|14719.851|||ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST||14719.851|10757.047|<0.001
71731683|NCT02008357|142977952|SUPERIORITY||LS Mean difference (Final Values)|996.411|STANDARD_ERROR_OF_MEAN|60.7404|<|0.001|TWO_SIDED|95.0|875.873|1116.948||p-value using ANCOVA model for endpoint measures: CHG = Baseline + APOE4 + AGE + Treatment.|ANCOVA|||Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST||1116.948|875.873|<0.001
71731684|NCT02008357|142977953|SUPERIORITY||LS Mean difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.0388||0.161|TWO_SIDED|95.0|-0.131|0.022|||ANCOVA|||Total hippocampal volume||0.022|-0.131|0.161
71731685|NCT02008357|142977953|SUPERIORITY||LS Mean difference (Final Values)|0.351|STANDARD_ERROR_OF_MEAN|0.4513||0.437|TWO_SIDED|95.0|-0.535|1.236|||ANCOVA|||Total Lateral Ventricular Volume||1.236|-0.535|0.437
71731686|NCT00966719|142977961|OTHER||Risk Ratio (RR)|0.84||||0.4|TWO_SIDED|95.0|0.56|1.24|||Fisher Exact|||||1.24|0.56|0.40
71731687|NCT00966719|142977962|OTHER||Risk Ratio (RR)|1.15||||1|TWO_SIDED|95.0|0.44|3.02|||Fisher Exact|||||3.02|0.44|1
71731688|NCT00966719|142977963|OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.91|1.1|||Fisher Exact|||||1.10|0.91|1
71731689|NCT00966719|142977964|OTHER||Risk Ratio (RR)|1.03||||0.78|TWO_SIDED|95.0|0.85|1.26|||Fisher Exact|||||1.26|0.85|0.78
71731690|NCT00966719|142977965|OTHER||Risk Ratio (RR)|2.94||||0.32|TWO_SIDED|95.0|0.32|27.3|||Fisher Exact|||||27.30|0.32|0.32
71731691|NCT00966719|142977966|OTHER||Risk Ratio (RR)|1.5||||0.09|TWO_SIDED|95.0|0.95|2.38|||Fisher Exact|||||2.38|0.95|0.09
71731692|NCT00966719|142977967|OTHER||Risk Ratio (RR)|1.03||||0.77|TWO_SIDED|95.0|0.83|1.27|||Fisher Exact|||||1.27|0.83|0.77
71731693|NCT00966719|142977968|OTHER||Risk Ratio (RR)|1.36||||0.6|TWO_SIDED|95.0|0.58|3.15|||Fisher Exact|||||3.15|0.58|0.6
71731694|NCT01710527|142977974|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed Cmax fell within the acceptance range of 80 to 125%.|Ratio (%)|96.85||||0.3125|TWO_SIDED|90.0|91.86|102.11|||ANOVA||Analysis was performed on log transformed geometric least square means.|||102.11|91.86|0.3125
71731695|NCT01710527|142977975|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-t fell within the acceptance range of 80 to 125%.|Ratio (%)|102.52||||0.2701|TWO_SIDED|90.0|98.74|106.45|||ANOVA|||Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-t||106.45|98.74|0.2701
71731696|NCT01710527|142977975|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-infinity fell within the acceptance range of 80 to 125%.|Ratio (%)|102.44||||0.2702|TWO_SIDED|90.0|98.78|106.23|||ANOVA||Analysis was performed on log transformed geometric least square means.|Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-infinity.||106.23|98.78|0.2702
71731697|NCT03921554|142978066|SUPERIORITY||Estimated change (52 weeks - baseline)|0.9|||<|0.0005|TWO_SIDED|95.0|0.5|1.2||The a priori threshold for statistical significance was \< 0.05.|Wald test||We fit a GEE model with AGS score as outcome and an indicator variable for 52 weeks. An exchangeable correlation structure was used to model intra-participant association of AGS scores. The model allowed for up to 2 measurements per participant.|"We are testing the null hypothesis is that the change from baseline (52 weeks - baseline) in AGS is zero.~45 participants had 2 measurements (at baseline and 52 weeks); 6 participants had 1 measurement (at baseline). All participants were included in the analysis."||1.2|0.5|<0.0005
71739142|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity||||0.0096
71658966|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
71658967|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
71658968|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
71831416|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.1||0.0937|TWO_SIDED|95.0|-0.31|4.01|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.01|-0.31|0.0937
71831417|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.11||0.1838|TWO_SIDED|95.0|-0.7|3.67|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||3.67|-0.70|0.1838
71658969|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
71731698|NCT03921554|142978067|SUPERIORITY||Estimated change (Day 673 - Day 0)|1.09|||<|0.0005|TWO_SIDED|95.0|0.57|1.62||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of AGS on day of treatment (modeled with cubic splines with knots at days 0, 84, 168, 336, 506, 673, and 1006). Goodness of fit criteria were used to select GEE model with AR(1) correlation structure.|We estimate change from Day 0 to Day 673 of treatment (Day 673 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||1.62|0.57|<0.0005
71831418|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|1.05||0.0025|TWO_SIDED|95.0|1.12|5.25|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.25|1.12|0.0025
71831419|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|1.04||0.0007|TWO_SIDED|95.0|1.51|5.6|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||5.60|1.51|0.0007
71831420|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|1.31||0.1373|TWO_SIDED|95.0|-0.62|4.51|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||4.51|-0.62|0.1373
71831421|NCT02528188|143167452|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|1.32||0.996|TWO_SIDED|95.0|-2.59|2.6|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.||2.60|-2.59|0.9960
71831422|NCT02528188|143167454|SUPERIORITY|||||||0.0823|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0823
71831423|NCT02528188|143167454|SUPERIORITY|||||||0.0049|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0049
71831424|NCT02528188|143167454|SUPERIORITY|||||||0.0718|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0718
71831425|NCT02528188|143167454|SUPERIORITY|||||||0.1947|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1947
71772309|NCT02821910|143044810|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.04|STANDARD_DEVIATION|17.9|||TWO_SIDED|90.0|90.23|110.91|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.91|90.23|
71772310|NCT02821910|143044810|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.24|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.58|108.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||108.38|94.58|
71772311|NCT02821910|143044811|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|97.5|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.94|105.71|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.71|89.94|
71772312|NCT02821910|143044811|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|117.31|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|103.41|133.07|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||133.07|103.41|
71772313|NCT02821910|143044811|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|102.74|STANDARD_DEVIATION|6.2|||TWO_SIDED|90.0|98.56|107.1|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.10|98.56|
71772314|NCT02821910|143044812|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.34|STANDARD_DEVIATION|6.6|||TWO_SIDED|90.0|92.13|100.75|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.75|92.13|
71772315|NCT02821910|143044812|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.07|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|99.95|110.45|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.45|99.95|
71772316|NCT02821910|143044812|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.31|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|96.41|104.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.38|96.41|
71772317|NCT02821910|143044813|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.63|STANDARD_DEVIATION|5.8|||TWO_SIDED|90.0|92.86|100.54|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.54|92.86|
71772318|NCT02821910|143044813|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|100.87|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|97.96|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|97.96|
71831426|NCT02528188|143167455|SUPERIORITY|||||||0.0229|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0229
71831427|NCT02528188|143167455|SUPERIORITY|||||||0.0029|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0029
71831428|NCT02528188|143167455|SUPERIORITY|||||||0.0266|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.0266
71831429|NCT02528188|143167455|SUPERIORITY|||||||0.1835|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1835
71831430|NCT02528188|143167456|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0076|TWO_SIDED|95.0|0.45|0.88|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.88|0.45|0.0076
71831431|NCT02528188|143167456|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0187|TWO_SIDED|95.0|0.48|0.94|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||0.94|0.48|0.0187
71831432|NCT02528188|143167457|SUPERIORITY|||||||0.0074|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0074
71658970|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
71658971|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
71658972|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
71658973|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
71831433|NCT02528188|143167457|SUPERIORITY|||||||0.0162|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.0162
71831434|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.15||||0.1136|TWO_SIDED|95.0|0.97|1.38|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.38|0.97|0.1136
71831435|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.08||||0.391|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.29|0.90|0.3910
71739143|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0234|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery||||0.0234
71739144|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0284|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery||||0.0284
71831436|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.03||||0.7691|TWO_SIDED|95.0|0.86|1.22|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.86|0.7691
71831437|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.88||||0.143|TWO_SIDED|95.0|0.73|1.05|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.05|0.73|0.1430
71831438|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.04||||0.6454|TWO_SIDED|95.0|0.87|1.25|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.25|0.87|0.6454
71831439|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.84||||0.0561|TWO_SIDED|95.0|0.7|1.0|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.00|0.70|0.0561
71831440|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9056|TWO_SIDED|95.0|0.82|1.19|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.82|0.9056
71772319|NCT02821910|143044813|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|99.75|STANDARD_DEVIATION|6.0|||TWO_SIDED|90.0|95.81|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.86|95.81|
71772320|NCT02821910|143044814|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|96.57|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|90.94|102.56|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.56|90.94|
71772321|NCT02821910|143044814|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.4|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|87.5|104.01|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.01|87.50|
71772322|NCT02821910|143044814|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|98.45|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|92.44|104.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.85|92.44|
71772323|NCT02821910|143044815|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|95.08|STANDARD_DEVIATION|12.6|||TWO_SIDED|90.0|87.36|103.48|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||103.48|87.36|
71772324|NCT02821910|143044815|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|105.72|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|98.78|113.15|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||113.15|98.78|
71772325|NCT02821910|143044815|SUPERIORITY_OR_OTHER_LEGACY||ratio (%)|101.61|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|92.0|112.22|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period', and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.22|92.00|
71772326|NCT01082640|143044819|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.134||0.459|TWO_SIDED|95.0|-0.37|0.17||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.17|-0.37|0.459
71889012|NCT00464204|143298980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-331.0|STANDARD_DEVIATION|1033.0||0.0185|TWO_SIDED|95.0|-640.0|-21.0||One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.|t-test, 1 sided||Considered difference: Voluven® minus NaCl 0.9 %|"Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl.~Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl."||-21|-640|0.0185
71772327|NCT01082640|143044819|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.133||0.789|TWO_SIDED|95.0|-0.23|0.3||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.||0.30|-0.23|0.789
71772328|NCT01082640|143044820|SUPERIORITY_OR_OTHER||LS mean difference|2.38|STANDARD_ERROR_OF_MEAN|1.687||0.162|TWO_SIDED|95.0|-0.97|5.73||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||5.73|-0.97|0.162
71772329|NCT01082640|143044820|SUPERIORITY_OR_OTHER||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|1.698||0.485|TWO_SIDED|95.0|-2.18|4.57||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||||4.57|-2.18|0.485
71772330|NCT01082640|143044821|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
71772331|NCT01082640|143044821|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||<0.001
71658974|NCT02912650|142833422|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
71658975|NCT02912650|142833423|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658976|NCT02912650|142833423|SUPERIORITY_OR_OTHER|||||||0.003|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.003
71658977|NCT02912650|142833423|SUPERIORITY_OR_OTHER|||||||0.031|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.031
71658978|NCT02912650|142833423|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658979|NCT02912650|142833423|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71731699|NCT03921554|142978068|SUPERIORITY||Estimated change (52 weeks - baseline)|2.2||||0.295|TWO_SIDED|95.0|-1.9|6.4||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.4|-1.9|0.295
71731700|NCT03921554|142978068|SUPERIORITY||Estimated change (52 weeks - baseline)|7.0||||0.007|TWO_SIDED|95.0|1.9|12.0||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||12.0|1.9|0.007
71731701|NCT03921554|142978068|SUPERIORITY||Estimated change (52 weeks - baseline)|0.26||||0.932|TWO_SIDED|95.0|-5.7|6.2||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model with GMFM-88 as outcome, with indicator variables for 52 weeks (vs. baseline) and cohorts B and C (vs. A); in addition, time by cohort interaction terms are included. The model allow for up to 2 measurements per participant.|"We are testing the null hypothesis that the change from baseline (52 weeks - baseline) in GMFM-88 is zero within cohorts.~35 participants had 2 measurements (at baseline and 52 weeks); 15 participants had 1 measurement (at baseline). All participants are included in the analysis."||6.2|-5.7|0.932
71731702|NCT03921554|142978069|SUPERIORITY||Estimated change (Day 3 - Day 0)|-8.76|||<|0.0005|TWO_SIDED|95.0|-11.7|-5.81||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a QLS model of ISG on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select QLS model with exchangeable correlation structure.|We estimate change from pre to post treatment (Day 3 minus Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-5.81|-11.7|<0.0005
71731703|NCT03921554|142978070|SUPERIORITY||Estimated change (day 335 minus day 0)|-0.11||||0.002|TWO_SIDED|95.0|-0.18|-0.04||The a priori threshold for statistical significance was \<0.05.|Wald test||We fit a GEE model of diary average score on day of treatment and indicator variable for post-treatment. Goodness of fit criteria were used to select GEE model with exchangeable correlation structure.|We estimate change from Day 0 to Day 335 (Day 335 - Day 0) with 95% confidence interval (CI). All participants are included in the analysis.||-0.04|-0.18|0.002
71772332|NCT01082640|143044821|SUPERIORITY_OR_OTHER|||||||0.062|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.||||||0.062
71658980|NCT02912650|142833423|SUPERIORITY_OR_OTHER|||||||0.631|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.631
71658981|NCT02912650|142833424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658982|NCT02912650|142833424|SUPERIORITY_OR_OTHER|||||||0.088|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.088
71658983|NCT02912650|142833424|SUPERIORITY_OR_OTHER|||||||0.133|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.133
71658984|NCT02912650|142833424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658985|NCT02912650|142833424|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||<0.001
71658986|NCT02912650|142833424|SUPERIORITY_OR_OTHER|||||||0.887|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.||||0.887
71658987|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.14|<0.001
71658988|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.034|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.034
71658989|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.963|TWO_SIDED|95.0|-0.13|0.14|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.13|0.963
71658990|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.062|TWO_SIDED|95.0|-0.01|0.37|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.01|0.062
71731704|NCT01299571|142978085|SUPERIORITY_OR_OTHER||Percentage of participants|3.8||||||95.0|3.2|4.4|||||The estimated value represents the percentage of participants with adverse events.|||4.4|3.2|
71731705|NCT01842581|142978098|NON_INFERIORITY|Threshold for significance=upper bound of the 2-sided 95% confidence interval (CI) for hazard ratio less than (\<) 1.56.|Hazard Ratio (HR)|1.959||||0.0359|TWO_SIDED|95.0|1.045|3.672|||Score statistics|||Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.672|1.045|0.0359
71731706|NCT01842581|142978099|SUPERIORITY|2-sided test at a significance level of 0.05.|Hazard Ratio (HR)|1.739||||0.0985|TWO_SIDED|95.0|0.894|3.382||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by analysis region. Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.||3.382|0.894|0.0985
71731707|NCT00530920|142978142|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.43||||0.997|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.997
71731708|NCT00530920|142978142|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.55||||1|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||1
71731709|NCT00530920|142978142|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.47||||0.998|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline \>1.2 log10 copies/mL within each group||||0.998
71731710|NCT00707746|142978161|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||It was estimated that the standard deviation of the percent change in LDL-C was 20%. A sample size of 30 patients was planned for this study: 20 patients in the mipomersen group and 10 patients in the placebo group. A 2-sided t-test with an alpha level of 0.05 was expected to provide ≥90% power to detect a 30% difference in LDL-C percent reduction between the 2 groups (35% reduction for the mipomersen group and 5% reduction for the placebo group).||||<0.001
71731711|NCT00707746|142978164|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon signed rank sum|||||||<0.001
71731712|NCT00707746|142978166|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71731713|NCT00707746|142978168|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71731714|NCT00707746|142978170|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.005
71731715|NCT00707746|142978172|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
71731716|NCT00707746|142978174|SUPERIORITY_OR_OTHER|||||||0.006||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.006
71731717|NCT00707746|142978176|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||<0.001
71731718|NCT00707746|142978178|SUPERIORITY_OR_OTHER|||||||0.784||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.784
71731719|NCT00707746|142978180|SUPERIORITY_OR_OTHER|||||||0.079||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided|||||||0.079
71731720|NCT01075971|142978233|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|||<|0.0001|TWO_SIDED|95.0|1.35|2.19||Analysis of variance with repeated measurements (daily scores from day 1 to day 5) for the whole set of patients was performed adjusted on the formulation (SL vs. FDT). Other independent factors were the subject and the day.|Analysis of variance|||||2.19|1.35|<0.0001
71731721|NCT02827500|142978252|SUPERIORITY||Odds Ratio, log|5.19||||0.002|TWO_SIDED|95.0|1.88|14.33|||Regression, Logistic|||||14.33|1.88|0.002
71731722|NCT02827500|142978253|SUPERIORITY|||||||0.011|||||||Regression, Linear|||||||0.011
71731723|NCT02827500|142978254|SUPERIORITY|||||||0.011|||||||Regression, Linear|||The null hypothesis tested was that there is no difference in change in heart rate between the treatment arms.||||0.011
71731724|NCT02827500|142978255|SUPERIORITY|||||||0.054||||||The apriori threshold for statistical significance is alpha=0.05.|Chi-squared, Corrected|The p-value is obtained using the F-test (combination of Chi-Squared tests) due to multiple imputation.||The null hypothesis tested was that there is no difference between the treatment arms in the proportion of patients with heart rate \< 70 BPM.||||0.054
71731725|NCT02827500|142978256|SUPERIORITY|||||||0.717|||||||Regression, Linear|||||||0.717
71731726|NCT02827500|142978257|SUPERIORITY|||||||0.784|||||||Regression, Linear|||||||0.784
71731727|NCT02358044|142978258|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||<|0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|||"Primary Analysis Approach: Non-Inferiority~Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided."||15.3|3.6|<0.001
71658991|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.001|TWO_SIDED|95.0|0.13|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|0.13|0.001
71658992|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.04|TWO_SIDED|95.0|-0.28|-0.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.01|-0.28|0.040
71658993|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
71658994|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.095|TWO_SIDED|95.0|-0.03|0.37|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.37|-0.03|0.095
71731728|NCT02358044|142978258|SUPERIORITY_OR_OTHER||Adjusted Difference in Percentage|8.8||||0.001|TWO_SIDED|95.0|3.6|15.3|||Miettinen & Nurminen Method|The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.||"Secondary Analysis Approach: Superiority~Analyses of the percentage of participants achieving SVR12 was conducted using the M\&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided."||15.3|3.6|0.001
71731729|NCT02358044|142978259|SUPERIORITY_OR_OTHER||Difference in Percentage|-41.7|||||TWO_SIDED|95.0|-51.1|-31.9||||||The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.||-31.9|-51.1|
71731730|NCT02358044|142978261|SUPERIORITY_OR_OTHER||Difference in Percentage|-27.0|||<|0.001|TWO_SIDED|95.0|-35.5|-19.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Total Tier 1 AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-19.6|-35.5|<0.001
71731731|NCT02358044|142978261|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.4||||0.078|TWO_SIDED|95.0|-6.8|0.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Serious drug-related AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||0.6|-6.8|0.078
71731732|NCT02358044|142978261|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.312|TWO_SIDED|95.0|-4.4|2.1||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"DC due to drug-related AE:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||2.1|-4.4|0.312
71739145|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery||||0.0679
71739146|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0003
71739147|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0728|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0728
71739148|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.0005
71658995|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.414|TWO_SIDED|95.0|-0.12|0.29|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.29|-0.12|0.414
71658996|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81|||<|0.001|TWO_SIDED|95.0|0.52|1.1|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.52|<0.001
71658997|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.61|1.19|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.61|<0.001
71658998|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.29|0.406
71658999|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.4|2.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.09|1.40|<0.001
71659000|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.006|TWO_SIDED|95.0|0.1|0.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.10|0.006
71659001|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33||||0.009|TWO_SIDED|95.0|0.08|0.57|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.57|0.08|0.009
71659002|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41|||<|0.001|TWO_SIDED|95.0|1.07|1.75|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|1.07|<0.001
71831441|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2919|TWO_SIDED|95.0|0.75|1.09|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.09|0.75|0.2919
71831442|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.94||||0.4976|TWO_SIDED|95.0|0.78|1.13|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.13|0.78|0.4976
71731733|NCT02358044|142978261|SUPERIORITY_OR_OTHER||Difference in Percentage|-12.7|||<|0.001|TWO_SIDED|95.0|-19.7|-8.0||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Neutrophil count \<0.75 x 10\^9/L:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-8.0|-19.7|<0.001
71831443|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.9||||0.2425|TWO_SIDED|95.0|0.75|1.08|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.08|0.75|0.2425
71831444|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9242|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9242
71831445|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6621|TWO_SIDED|95.0|0.8|1.15|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.15|0.80|0.6621
71831446|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9977|TWO_SIDED|95.0|0.83|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.83|0.9977
71831447|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9762|TWO_SIDED|95.0|0.84|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.20|0.84|0.9762
71831448|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9718|TWO_SIDED|95.0|0.83|1.19|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.19|0.83|0.9718
71831449|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8219|TWO_SIDED|95.0|0.85|1.22|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.22|0.85|0.8219
71831450|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|0.96||||0.6936|TWO_SIDED|95.0|0.8|1.16|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.16|0.80|0.6936
71831451|NCT02528188|143167458|SUPERIORITY||Odds Ratio (OR)|1.05||||0.5769|TWO_SIDED|95.0|0.88|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.||1.26|0.88|0.5769
71831452|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.07||0.7746|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.7746
71889013|NCT02649634|143299011|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05.|Mixed Models Analysis|||Linear mixed modelling (LMM) was used||||>.05
71831453|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.07||0.8441|TWO_SIDED|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.89|0.8441
71831454|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.08||0.658|TWO_SIDED|95.0|0.83|1.13|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.83|0.6580
71889014|NCT02649634|143299012|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
71889015|NCT02649634|143299013|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.||||||0.65|||||||t-test, 2 sided|||Treatment adherence was analyzed via an independent sample t-test comparing the groups on mean number of TrymGym sessions missed.||||.65
71889016|NCT02649634|143299014|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
71889017|NCT02649634|143299015|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used||||>.05
71889018|NCT02649634|143299016|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889019|NCT02649634|143299017|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889020|NCT02649634|143299018|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889021|NCT02649634|143299019|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889022|NCT02649634|143299020|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889023|NCT02649634|143299021|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71731734|NCT02358044|142978261|SUPERIORITY_OR_OTHER||Difference in Percentage|-13.5|||<|0.001|TWO_SIDED|95.0|-20.8|-7.9||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M\&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Hemoglobin \<10 g/dL:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."||-7.9|-20.8|<0.001
71739149|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.0005
71659003|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.08|1.77|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.77|1.08|<0.001
71731735|NCT02358044|142978262|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||||TWO_SIDED|95.0|3.3|15.7||||||Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen \& Nurminen (M\&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.||15.7|3.3|
71739150|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.0078
71739151|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0078|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.0078
71659004|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.908|TWO_SIDED|95.0|-0.26|0.23|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.23|-0.26|0.908
71739152|NCT01846741|142991054|SUPERIORITY_OR_OTHER|||||||0.0273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.0273
71739153|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0192|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0192
71739154|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.8069|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.8069
71739155|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.2416
71739156|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.1111|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1111
71739157|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0014
71739158|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.3247|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3247
71739159|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0826
71739160|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1040
71739161|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0094
71739162|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.5874|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.5874
71739163|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.1508|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1508
71739164|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.0136
71739165|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0015
71739166|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.3522|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.3522
71739167|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0240
71739168|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0353
71739169|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0361
71739170|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.1921|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue||||0.1921
71889024|NCT02649634|143299022|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889025|NCT02649634|143299023|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889026|NCT02649634|143299024|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71659005|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.99|||<|0.001|TWO_SIDED|95.0|1.64|2.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.35|1.64|<0.001
71731736|NCT01739803|142978264|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||To control for experiment-wise Type I error rate in this analysis, a comparison-wise alpha of 0.01 was used.|Mixed Models Analysis|||We projected mean composite adherence rate for all participants to be approximately 80% ± 15. We anticipated at least 10% increase in intervention group adherence at end of intervention. To have 80% power to detect expected difference of 10% at the 2-tailed 5% significance level, sample size needed to be at least 36 RTRs per group. We took a conservative approach, in combination with anticipated attrition over the course of study, and increased enrollment.||||<0.05
71731737|NCT01739803|142978265|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71731738|NCT01739803|142978266|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.05||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71731739|NCT01428336|142978267|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.06|||||TWO_SIDED|95.0|-0.2|0.6||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT||0.60|-0.20|
71731740|NCT01428336|142978267|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.07|||||TWO_SIDED|95.0|-0.69|-0.01||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT||-0.01|-0.69|
71731741|NCT01428336|142978267|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.06|||||TWO_SIDED|95.0|-0.65|0.04||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT||0.04|-0.65|
71731742|NCT01428336|142978268|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.12|||||TWO_SIDED|95.0|-0.24|0.65||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol||0.65|-0.24|
71731743|NCT01428336|142978268|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.18|||||TWO_SIDED|95.0|-0.91|-0.15||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol||-0.15|-0.91|
71731744|NCT01428336|142978268|NON_INFERIORITY|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.19|||||TWO_SIDED|95.0|-0.94|-0.14||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol||-0.14|-0.94|
71731745|NCT02525094|142978279|SUPERIORITY||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.9|4.33||||||||4.33|0.90|
71739171|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being||||0.1639
71739172|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.1738|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning||||0.1738
71739173|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning||||0.0401
71739174|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.2753|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects||||0.2753
71739175|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0056
71739176|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.1173|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.1173
71739177|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.0268
71659006|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.002|TWO_SIDED|95.0|0.15|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.15|0.002
71659007|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.32|0.82|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.82|0.32|<0.001
71659008|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.25|1.95|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|1.25|<0.001
71731746|NCT01751776|142978293|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0506|STANDARD_ERROR_OF_MEAN|0.4242|||TWO_SIDED|95.0|1.1843|2.9168|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the first adminstration of BI 65564 on Day 1.||2.9168|1.1843|
71731747|NCT01751776|142978293|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4227|STANDARD_ERROR_OF_MEAN|0.1644|||TWO_SIDED|95.0|1.0869|1.7584|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for Cmax was explored after the last (fourth) adminstration of BI 65564 on Day 22.||1.7584|1.0869|
71731748|NCT01751776|142978294|SUPERIORITY_OR_OTHER_LEGACY||Slope|2.0091|STANDARD_ERROR_OF_MEAN|0.1706|||TWO_SIDED|95.0|1.6607|2.3575|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUC 0-infinity was explored after the last adminstration of BI 65564 on Day 22.||2.3575|1.6607|
71772333|NCT02011893|143044855|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.|||||<|0.001|||||||t-distribution|95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||<0.001
71772334|NCT02011893|143044856|SUPERIORITY_OR_OTHER|||||||0.083||||||Superiority analysis performed|McNemar|||||||0.083
71772335|NCT02011893|143044858|SUPERIORITY_OR_OTHER|||||||0.017||||||Superiority analysis performed|t-distribution|95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.||||||0.017
71772336|NCT01289782|143044859|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|29.3|||<|0.001|TWO_SIDED|95.0|20.1|38.6|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||38.6|20.1|<0.001
71772337|NCT01289782|143044860|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|28.9|||<|0.001|TWO_SIDED|95.0|19.6|38.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVRW72 between the treatment groups.||38.2|19.6|<0.001
71772338|NCT01289782|143044861|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|30.1|||<|0.001|TWO_SIDED|95.0|20.8|39.3|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||39.3|20.8|<0.001
71831455|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.07||0.2279|TWO_SIDED|95.0|0.78|1.06|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.06|0.78|0.2279
71659009|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|1.07|1.78|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.78|1.07|<0.001
71731749|NCT01751776|142978295|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.4225|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.0876|1.7574|||||Dose proportionality was explored using a regression model. Based on the estimate for the slope parameter, a 2-sided 95% CI was computed. Perfect dose proportionality would correspond to a slope of 1. PK endpoints on the log-transformed scale.|Dose proportionality for AUCtau was explored after the last administration of BI 65564 on Day 22.||1.7574|1.0876|
71772339|NCT01289782|143044862|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|25.8|||<|0.001|TWO_SIDED|95.0|16.8|34.8|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR4 between the treatment groups.||34.8|16.8|<0.001
71772340|NCT01289782|143044889|SUPERIORITY_OR_OTHER||Mean differences|-20.679|STANDARD_ERROR_OF_MEAN|6.0979|<|0.001|TWO_SIDED|95.0|-32.6399|-8.7181|||Piecewise-Linear Model Approach|||Fatigue Severity Score AUC60||-8.7181|-32.6399|<0.001
71772341|NCT01289782|143044889|SUPERIORITY_OR_OTHER||Mean differences|-23.8|STANDARD_ERROR_OF_MEAN|7.2358|<|0.001|TWO_SIDED|95.0|-37.9931|-9.6064|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-9.6064|-37.9931|<0.001
71772342|NCT01289782|143044890|SUPERIORITY_OR_OTHER||Mean differences|-230.464|STANDARD_ERROR_OF_MEAN|105.9203||0.03|TWO_SIDED|95.0|-438.2662|-22.6626|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-22.6626|-438.2662|0.030
71772343|NCT01289782|143044890|SUPERIORITY_OR_OTHER||Mean differences|-248.208|STANDARD_ERROR_OF_MEAN|124.6753||0.047|TWO_SIDED|95.0|-492.8253|-3.5916|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-3.5916|-492.8253|0.047
71772344|NCT01289782|143044891|SUPERIORITY_OR_OTHER||Mean Differences|-278.06|STANDARD_ERROR_OF_MEAN|105.6088||0.009|TWO_SIDED|95.0|-485.2529|-70.8668|||Piecewise linear model|||Impairment in Daily Activities AUC60||-70.8668|-485.2529|0.009
71772345|NCT01289782|143044891|SUPERIORITY_OR_OTHER||Mean differences|-307.722|STANDARD_ERROR_OF_MEAN|124.1956||0.013|TWO_SIDED|95.0|-551.4006|-64.0429|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-64.0429|-551.4006|0.013
71772346|NCT01289782|143044892|SUPERIORITY_OR_OTHER||Mean differences|46.399|STANDARD_ERROR_OF_MEAN|99.7966||0.642|TWO_SIDED|95.0|-149.6374|242.436|||Piecewise linear model|||Time Missed from Work AUC60||242.4360|-149.6374|0.642
71772347|NCT01289782|143044892|SUPERIORITY_OR_OTHER||Mean differences|57.164|STANDARD_ERROR_OF_MEAN|115.1548||0.62|TWO_SIDED|95.0|-169.1143|283.4414|||Piecewise Linear Model|||Time Missed from Work AUC72||283.4414|-169.1143|0.620
71659010|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.157|TWO_SIDED|95.0|-0.07|0.43|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.07|0.157
71731750|NCT01751776|142978297|OTHER||Mean Difference (Net)|22.7|||||||||||||Mean Difference in percentage|Observed difference of ACR20 response for BI 120mg - Placebo||||
71731751|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Mean Difference (Net)|33.0|||||||||||||Mean Difference in percentage|Expected difference of ACR20 response for BI 120mg - Placebo||||
71731752|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 0%||||
71731753|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|99.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 5%||||
71731754|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|98.7||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 10%||||
71731755|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|96.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 15%||||
71731756|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|90.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 20%||||
71731757|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|79.0||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 25%||||
71731758|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|62.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 30%||||
71731759|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|42.9||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 35%||||
71731760|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|24.5||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 40%||||
71731761|NCT01751776|142978297|OTHER|Evaluation of the difference in ACR20 response rates using a Bayesian approach. Results based on 1000000 simulations of the posterior distribution; for the treatment group a non-informative beta (0,0) prior was used; for the placebo group, an informative beta (5.5, 16.5) prior was used; prior to any imputation, assessments up to the End of Trial (EoT) visit were mapped to an on-treatment visit window (Visit 4/Week 2 - Visit 14 (EoT)/Week 12) relative to the day of the first dose.|Probability in percentage|11.1||||||||||||||Probability that difference of ACR20 response for BI 120mg - Placebo is larger than 45%||||
71772348|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0081||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to post intervention||||0.0081
71772349|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0243||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to post intervention||||0.0243
71772350|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.071||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to post intervention||||0.0710
71772351|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0008||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to post intervention||||0.0008
71772352|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1094||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from baseline to one-month follow-up||||0.1094
71772353|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2029||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from baseline to one-month follow-up||||0.2029
71772354|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8599||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from baseline to one-month follow-up||||0.8599
71831456|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.09||0.9986|TWO_SIDED|95.0|0.84|1.18|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.84|0.9986
71831457|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.07||0.0771|TWO_SIDED|95.0|0.72|1.02|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.02|0.72|0.0771
71831458|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.09||0.4485|TWO_SIDED|95.0|0.77|1.13|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.77|0.4485
71831459|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.2817|TWO_SIDED|95.0|0.74|1.09|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.09|0.74|0.2817
71831460|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5426|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5426
71659011|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.73|2.48|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.48|1.73|<0.001
71772355|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0007||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from baseline to one-month follow-up||||0.0007
71772356|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0246||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing total knowledge score change between groups from post-intervention to one-month follow-up||||0.0246
71831461|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5385|TWO_SIDED|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.13|0.79|0.5385
71831462|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.09||0.5041|TWO_SIDED|95.0|0.79|1.12|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.12|0.79|0.5041
71772357|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.078||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing zoster knowledge score change between groups from post-intervention to one-month follow-up||||0.0780
71772358|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0167||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing pneumonia knowledge score change between groups from post-intervention to one-month follow-up||||0.0167
71659012|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.005|TWO_SIDED|95.0|0.11|0.63|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|0.11|0.005
71659013|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|||<|0.001|TWO_SIDED|95.0|0.52|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.52|<0.001
71659014|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.1|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.10|1.36|<0.001
71659015|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.94|1.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.94|<0.001
71659016|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.002|TWO_SIDED|95.0|0.15|0.68|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.15|0.002
71659017|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|2.06|||<|0.001|TWO_SIDED|95.0|1.67|2.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.45|1.67|<0.001
71659018|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.004|TWO_SIDED|95.0|0.13|0.67|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.13|0.004
71659019|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.37|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.82|<0.001
71659020|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.27|2.04|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.04|1.27|<0.001
71659021|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|||<|0.001|TWO_SIDED|95.0|0.58|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.58|<0.001
71731762|NCT01751776|142978298|SUPERIORITY_OR_OTHER_LEGACY||Risk difference, unadjusted|18.2||||0.0754|TWO_SIDED|95.0|-6.6|38.6|||One-sided exact test (see description)|One-sided exact test for superiority testing|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||38.6|-6.6|0.0754
71731763|NCT01751776|142978298|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|20.0|||||TWO_SIDED|95.0|-4.6|39.0|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-Tumour Necrosis Factor (TNF)|adjusted||39.0|-4.6|
71731764|NCT01751776|142978299|SUPERIORITY_OR_OTHER_LEGACY||risk difference, unadjusted|4.5||||0.3938|TWO_SIDED|95.0|-18.4|22.3|||one-sided exact test (see description)|one-sided exact test for superiority testing.|The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||22.3|-18.4|0.3938
71659022|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.42|0.96|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.96|0.42|<0.001
71659023|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.001|TWO_SIDED|95.0|1.6|2.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.40|1.60|<0.001
71659024|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.72|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|0.16|0.002
71659025|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.88|1.44|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.88|<0.001
71659026|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.16|1.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.96|1.16|<0.001
71659027|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.44|1.24|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.44|<0.001
71659028|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.44|1.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.44|<0.001
71659029|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.5|2.31|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.50|<0.001
71659030|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.001|TWO_SIDED|95.0|0.18|0.74|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.74|0.18|0.001
71659031|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.85|1.43|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.85|<0.001
71659032|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|1.04|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.85|1.04|<0.001
71659033|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.77|||<|0.001|TWO_SIDED|95.0|0.36|1.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.17|0.36|<0.001
71659034|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.39|0.97|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|0.39|<0.001
71731765|NCT01751776|142978299|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|4.0|||||TWO_SIDED|95.0|-18.9|21.1|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||21.1|-18.9|
71731766|NCT01751776|142978302|SUPERIORITY_OR_OTHER_LEGACY||Risk difference|6.8|||||TWO_SIDED|95.0|-17.6|32.7|||||The exact 95% confidence interval was calculated by Clopper and Pearson.|unadjusted||32.7|-17.6|
71731767|NCT01751776|142978302|SUPERIORITY_OR_OTHER_LEGACY||risk difference, adjusted|8.9|||||TWO_SIDED|95.0|-15.9|34.2|||||The 95 % confidence interval was determined by root method to determine the cumulative distribution function. Adjusted for treatment, region and anti-TNF history|adjusted||34.2|-15.9|
71731768|NCT01751776|142978303|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean|-0.14|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|95.0|-0.67|0.39|||||difference calculated as BI 655064 120mg minus placebo. The ANCOVA model was used. In this model the mean was adjusted for region, anti-TNF history and baseline DAS28-CRP.|difference calculated as BI 655064 120mg minus placebo.||0.39|-0.67|
71731769|NCT01122108|142978314|SUPERIORITY_OR_OTHER||||||<|0.05||||||If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.|repeated measures analysis of variance|Sensitivity analyses were run to evaluate possible product by sequence interactions||"The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed."||||<0.05
71731770|NCT03474081|142978321|SUPERIORITY||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.0167|<|0.001|TWO_SIDED|95.0|0.062|0.128||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.128|0.062|<0.001
71731771|NCT03474081|142978322|SUPERIORITY||Mean Difference (Net)|0.122|STANDARD_ERROR_OF_MEAN|0.0144|<|0.001|TWO_SIDED|95.0|0.094|0.15||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.150|0.094|<0.001
71731772|NCT03474081|142978323|SUPERIORITY||Mean Difference (Net)|0.087|STANDARD_ERROR_OF_MEAN|0.0159|<|0.001|TWO_SIDED|95.0|0.056|0.118||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)|||||0.118|0.056|<0.001
71731773|NCT01831817|142978367|SUPERIORITY_OR_OTHER||Mean change difference|-0.1||||0.4321|TWO_SIDED|95.0|-0.35|0.15|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference was First named treatment-second named treatment that a negative difference implied the mean of the second named treatment was larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.15|-0.35|0.4321
71731774|NCT01831817|142978367|SUPERIORITY_OR_OTHER||Mean change difference|-0.48||||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.23|-0.73|0.0002
71731775|NCT01831817|142978367|SUPERIORITY_OR_OTHER||Mean change difference|-0.49||||0.0002|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.24|-0.74|0.0002
71731776|NCT01831817|142978367|SUPERIORITY_OR_OTHER||Mean change difference|0.38||||0.0028|TWO_SIDED|95.0|0.13|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.63|0.13|0.0028
71731777|NCT01831817|142978367|SUPERIORITY_OR_OTHER||Mean change difference|0.39||||0.0022|TWO_SIDED|95.0|0.14|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons||0.63|0.14|0.0022
71731778|NCT01831817|142978367|SUPERIORITY_OR_OTHER||Mean change difference|-0.01||||0.9606|TWO_SIDED|95.0|-0.25|0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.24|-0.25|0.9606
71731779|NCT01831817|142978368|SUPERIORITY_OR_OTHER||Mean change difference|0.04||||0.803|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.38|-0.30|0.8030
71739178|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.4406|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final||||0.4406
71739179|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.7926|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional Well Being Final||||0.7926
71739180|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0987|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final||||0.0987
71731780|NCT01831817|142978368|SUPERIORITY_OR_OTHER||Mean change difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.48|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.48|-1.16|<0.0001
71889027|NCT02649634|143299025|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71889028|NCT02649634|143299026|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas \& Hox, 2005). Others have suggested 30-50 participants (Scherbaum \& Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.||||>.05
71731781|NCT01831817|142978368|SUPERIORITY_OR_OTHER||Mean change difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.53|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||-0.53|-1.20|<0.0001
71731782|NCT01831817|142978368|SUPERIORITY_OR_OTHER||Mean change difference|0.86|||<|0.0001|TWO_SIDED|95.0|0.53|1.19|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.19|0.53|<0.0001
71731783|NCT01831817|142978368|SUPERIORITY_OR_OTHER||Mean change difference|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||1.23|0.58|<0.0001
71731784|NCT01831817|142978368|SUPERIORITY_OR_OTHER||Mean change difference|-0.04||||0.7872|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons||0.28|-0.37|0.7872
71731785|NCT01831817|142978369|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9642|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.9642
71731786|NCT01831817|142978369|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0016|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0016
71731787|NCT01831817|142978369|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.01|TWO_SIDED|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|0.00|0.0100
71731788|NCT01831817|142978369|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.002|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0020
71731789|NCT01831817|142978369|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.0122|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|0.00|0.0122
71731790|NCT01831817|142978369|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.7138|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.7138
71731791|NCT01831817|142978370|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.9834|TWO_SIDED|95.0|-5.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||5.00|-5.00|0.9834
71731792|NCT01831817|142978370|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|5.0||||0.0001|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0001
71731793|NCT01831817|142978370|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|2.5||||0.0003|TWO_SIDED|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||15.00|0.00|0.0003
71731794|NCT01831817|142978370|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0|||<|0.0001|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|<0.0001
71731795|NCT01831817|142978370|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|-5.0||||0.0002|TWO_SIDED|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment|||0.00|-10.00|0.0002
71731796|NCT01831817|142978370|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift|0.0||||0.2894|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment|||0.00|0.00|0.2894
71731797|NCT01831817|142978371|SUPERIORITY_OR_OTHER||Mean change difference|-0.24||||0.5555|TWO_SIDED|95.0|-1.03|0.56|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.56|-1.03|0.5555
71731798|NCT01831817|142978371|SUPERIORITY_OR_OTHER||Mean change difference|-0.06||||0.8769|TWO_SIDED|95.0|-0.86|0.73|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.73|-0.86|0.8769
71889029|NCT02649634|143299027|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
71889030|NCT02649634|143299028|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
71731799|NCT01831817|142978371|SUPERIORITY_OR_OTHER||Mean change difference|-0.76||||0.0562|TWO_SIDED|95.0|-1.55|0.02|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.02|-1.55|0.0562
71731800|NCT01831817|142978371|SUPERIORITY_OR_OTHER||Mean change difference|-0.18||||0.6562|TWO_SIDED|95.0|-0.95|0.6|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.60|-0.95|0.6562
71731801|NCT01831817|142978371|SUPERIORITY_OR_OTHER||Mean change difference|0.53||||0.1788|TWO_SIDED|95.0|-0.24|1.3|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.30|-0.24|0.1788
71731802|NCT01831817|142978371|SUPERIORITY_OR_OTHER||Mean change difference|-0.7||||0.0734|TWO_SIDED|95.0|-1.47|0.07|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.07|-1.47|0.0734
71731803|NCT01831817|142978372|SUPERIORITY_OR_OTHER||Mean change difference|0.19||||0.6727|TWO_SIDED|95.0|-0.71|1.1|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||1.10|-0.71|0.6727
71889031|NCT02649634|143299029|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.||||>.05
71731804|NCT01831817|142978372|SUPERIORITY_OR_OTHER||Mean change difference|-1.24||||0.0072|TWO_SIDED|95.0|-2.14|-0.34|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.34|-2.14|0.0072
71731805|NCT01831817|142978372|SUPERIORITY_OR_OTHER||Mean change difference|-1.27||||0.0056|TWO_SIDED|95.0|-2.16|-0.38|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||-0.38|-2.16|0.0056
71731806|NCT01831817|142978372|SUPERIORITY_OR_OTHER||Mean change diference|1.43||||0.0016|TWO_SIDED|95.0|0.56|2.31|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.31|0.56|0.0016
71731807|NCT01831817|142978372|SUPERIORITY_OR_OTHER||Mean change difference|1.46||||0.0011|TWO_SIDED|95.0|0.59|2.33|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||2.33|0.59|0.0011
71731808|NCT01831817|142978372|SUPERIORITY_OR_OTHER||Mean change difference|-0.03||||0.9413|TWO_SIDED|95.0|-0.9|0.84|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment|||0.84|-0.90|0.9413
71772359|NCT03239665|143044898|EQUIVALENCE|Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.9417||||||Two-sided Wilcoxon Rank-Sum test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Wilcoxon (Mann-Whitney)|||Testing influenza knowledge score change between groups from post-intervention to one-month follow-up||||0.9417
71772360|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0011||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||0.0011
71739181|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0361|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final||||0.0361
71739182|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0615|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final||||0.0615
71739183|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry||||0.0024
71731809|NCT01742065|142978385|SUPERIORITY|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.|Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.1|6.8||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||6.8|.1|.05
71731810|NCT01742065|142978386|OTHER|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.|Mean Difference (Final Values)|3.8||||0.02|TWO_SIDED|95.0|0.6|7.0||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.||||7|.6|.02
71731811|NCT05065190|142978398|OTHER||Adjusted difference|106.57|STANDARD_ERROR_OF_MEAN|76.84|||TWO_SIDED|95.0|-47.13|260.28|||||Adjusted difference between treatment groups was based on a random slope and intercept model with fixed effects for treatment, HRCT pattern, and baseline FVC \[mL\], and including treatment-by-time and baseline-by-time interactions.|||260.28|-47.13|
71731812|NCT03320330|142978438|OTHER|Recommended Phase 2 dose of pepinemab (VX15/2503), administered to children with recurrent or refractory solid tumors (Part A), was determined by the rolling-6 design.|Recommended Phase 2 dose|20.0|||||TWO_SIDED||||||||Recommended Phase 2 dose of pepinemab (VX15/2503) is 20 mg/kg.|||||
71731813|NCT04692077|142978470|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Reported Grade 2 and Above AEs|99.7|51.8|
71731814|NCT04692077|142978471|OTHER||Exact CI for Proportions|11.1|||||TWO_SIDED|95.0|0.3|48.3|||||||Exact 95% Confidence Interval for Proportion for Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedures|48.3|0.3|
71731815|NCT04692077|142978472|OTHER||Exact CI for Proportions|66.7|||||TWO_SIDED|95.0|22.3|95.7|||||||Exact 95% confidence interval for proportion for Participants who received at least one injection and preferred injectable PrEP at end of step 2.|95.7|22.3|
71731816|NCT04692077|142978476|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||The Exact 95% Confidence Interval for Proportion for Number of Participants with Grade 2 or above AEs during Injection Phase.|99.7|51.8|
71731817|NCT04692077|142978477|OTHER||Exact CI for Proportions|88.9|||||TWO_SIDED|95.0|51.8|99.7|||||||Exact 95% Confidence Interval for Proportion for Participants who Completed All Scheduled Injections among those who received at least one Injection|99.7|51.8|
71731818|NCT04243330|142978481|SUPERIORITY||Mean Difference (Net)|1.01||||0.18|TWO_SIDED|95.0|-0.46|2.48||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.48|-0.46|0.18
71731819|NCT04243330|142978482|SUPERIORITY||Mean Difference (Net)|3.58||||0.06|TWO_SIDED|95.0|-0.11|7.28||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.28|-0.11|.06
71731820|NCT04243330|142978483|SUPERIORITY||Median Difference (Net)|1.7||||0.6|TWO_SIDED|95.0|-4.5|7.9||the p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||7.9|-4.5|0.60
71731821|NCT04243330|142978484|SUPERIORITY||Median Difference (Net)|-4.1||||0.36|TWO_SIDED|95.0|-12.8|4.7||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||4.7|-12.8|0.36
71731822|NCT04243330|142978485|SUPERIORITY||Mean Difference (Net)|-4.5||||0.02|TWO_SIDED|95.0|-8.3|-0.67||p-values are not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||-0.67|-8.3|.02
71731823|NCT04243330|142978486|SUPERIORITY||Mean Difference (Net)|-0.56||||0.82|TWO_SIDED|95.0|-5.5|4.4|||Mixed Models Analysis|||||4.4|-5.5|0.82
71731824|NCT01657760|142978488|EQUIVALENCE|80% power to detect difference p\<0.05 two tailed|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.87|TWO_SIDED|||||ANOVA, uncorrected for MC.|ANOVA|||||||0.87
71731825|NCT01694108|142978512|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Whitney-test comparing the decisional conflict scores of participating mothers vs. declining mothers.||||||<0.001
71731826|NCT02936284|142978550|SUPERIORITY||Mean Difference (Net)|0.196||||0.016|TWO_SIDED||||||Mixed Models Analysis|mixed effect regression model including covariates: child sex, child birth weight, breastfeeding duration, percent class attendance and covid grouping|difference between music and play group change|||||0.016
71731827|NCT02936284|142978551|SUPERIORITY||Mean Difference (Net)|29.9||||0.7|TWO_SIDED||||||Mixed Models Analysis||music group vs. play group baseline to 24 months|mixed effect regression analysis, unstructured covariance, no covariates. Reporting group x time interaction||||0.70
71731828|NCT02936284|142978552|SUPERIORITY||Mean Difference (Net)|0.073||||0.54|TWO_SIDED||||||Mixed Models Analysis||increase in weight for length z-score for music group|mixed-effect regression analysis with covariates: child sex, birth weight, breastfeeding duration, percent class attendance and covid categories||||0.540
71739184|NCT01846741|142991055|SUPERIORITY_OR_OTHER|||||||0.0155|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life||||0.0155
71739185|NCT01846741|142991057|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||3 months||||0.0625
71739186|NCT01846741|142991057|SUPERIORITY_OR_OTHER|||||||0.1094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||6 months||||0.1094
71772361|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to post-intervention"||||<0.0001
71889032|NCT02649634|143299030|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.||||>.05
71731829|NCT03859739|142978563|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.79|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 2.44 %.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71731830|NCT03859739|142978563|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.97|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 7.60%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71731831|NCT03859739|142978563|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.58|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 74.99%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71731832|NCT03859739|142978563|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.78|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8558 and placebo ≤ -1.4 copies/mL was 87.41%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK-8558 and placebo is ≥ 1.4 log10 copies/mL.||||
71731833|NCT03859739|142978571|OTHER||Standard Error (SE)|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 0.25%.|The posterior probability (PP) that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71731834|NCT03859739|142978571|OTHER||SE|0.146|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 65.41%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71731835|NCT03859739|142978571|OTHER||SE|0.133|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.99%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71731836|NCT03859739|142978571|OTHER||SE|0.163|||||||||||||PP that the true C168hr in plasma MK-8558 is ≥ 9.0 μM was 99.98%.|The PP that the true GM C168hr is ≥ 9.0 μM was calculated using a non-informative (Jeffrey's) prior under an assumption of normality of log C168hr.||||
71731837|NCT01300351|142978629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.078|TWO_SIDED|95.0|0.54|1.03||With a sample size of 220 randomised patients and 150 progression events, if treatment effect is consistent between ethnicities/the study populations, there is an 89% chance the HR \<1.|Log Rank|||The results of this study would be considered to be consistent with that of the CONFIRM study if the hazard ratio (HR) point estimate for the treatment comparison was \<1 (ie, it favoured fulvestrant 500 mg), without the requirement for the benefit of fulvestrant 500 mg to be statistically significant.||1.03|0.54|0.078
71731838|NCT01300351|142978630|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.107|TWO_SIDED|95.0|0.93|2.24|||Regression, Logistic|||||2.24|0.93|0.107
71731839|NCT01300351|142978631|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.023|TWO_SIDED|95.0|1.04|1.8|||Regression, Logistic|||||1.80|1.04|0.023
71731840|NCT00673881|142978658|SUPERIORITY_OR_OTHER|||||||0.0042||95.0|||||t-test, 2 sided|||||||0.0042
71731841|NCT00673881|142978659|SUPERIORITY_OR_OTHER|||||||0.0002|||||||t-test, 2 sided|||Comparison baseline to end-of-treatment||||0.0002
71731842|NCT00673881|142978660|SUPERIORITY_OR_OTHER||||||NS|0|||||||t-test, 2 sided|||Comparison from baseline to end-of-treatment||||NS
71731843|NCT00673881|142978668|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71731844|NCT00689793|142978669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|2.5||0.69|TWO_SIDED|95.0|0.0|10.0||Significant level of treatment effect was set at p\<0.05|Regression, Linear|Level of fatigue at four weeks:dependant variable. Group allocation and level of fatigue at baseline: independant variables.||The null hypothesis was that there was no difference in fatigue VAS scores between the treatment and placebo groups at 4 weeks||10|0|0.69
71731845|NCT00689793|142978670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|6.5|<|0.05||95.0|0.0|10.0|||Regression, Linear|Hemoglobin value at four weeks : dependant variable. Group allocation and hemoglobin value at baseline : independant variables.||||10|0|<0.05
71731846|NCT00689793|142978671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|8.0|<|0.05|TWO_SIDED|95.0|0.0|30.0|||Regression, Linear|Ferritin level at 4 weeks : dependant variable. Group allocation and ferritin level at baseline: independant variables.||||30|0|<0.05
71731847|NCT00689793|142978672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|3.0||0.05|TWO_SIDED|95.0|0.0|6.0|||Regression, Linear|Aerobic capacity at 4 weeks : dependant variables. Group allocation and aerobic capacity at baseline : independant variable.||||6|0|0.05
71731848|NCT03968159|142978678|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.82||0.2956|TWO_SIDED|95.0|-2.5|0.8|||Mixed-effects model for repeated measure|||||0.8|-2.5|0.2956
71731849|NCT05260333|142978689|OTHER||correlation coefficient|0.81||||0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.0001
71731850|NCT01541917|142978708|SUPERIORITY_OR_OTHER||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.06|-0.02|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since group procedures were initiated.|Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable||-.02|-.06|<.001
71731851|NCT01541917|142978708|SUPERIORITY_OR_OTHER||Slope|-0.014|STANDARD_ERROR_OF_MEAN|0.021||0.51|TWO_SIDED|95.0|-0.055|0.027|||Multilevel growth model||The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.027|-.055|.51
71731852|NCT01541917|142978709|SUPERIORITY_OR_OTHER||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.27|0.46|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.46|.27|<.001
71731853|NCT01541917|142978709|SUPERIORITY_OR_OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.101||0.59|TWO_SIDED|95.0|-0.144|0.252|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.252|-.144|.59
71731854|NCT01541917|142978710|SUPERIORITY_OR_OTHER||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|0.1|0.14|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.14|.10|<.001
71731855|NCT01541917|142978710|SUPERIORITY_OR_OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.63|TWO_SIDED|95.0|-0.05|0.03|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.03|-.05|.63
71731856|NCT01541917|142978711|SUPERIORITY_OR_OTHER||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.02|TWO_SIDED|95.0|-0.18|-0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||-.01|-.18|.02
71731857|NCT01541917|142978711|SUPERIORITY_OR_OTHER||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.084||0.91|TWO_SIDED|95.0|-0.174|0.155|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.155|-.174|.91
71731858|NCT01541917|142978712|SUPERIORITY_OR_OTHER||Slope|0.0316|STANDARD_ERROR_OF_MEAN|0.004|<|0.001|TWO_SIDED|95.0|0.02|0.04|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable||.04|.02|<.001
71739187|NCT01846741|142991057|SUPERIORITY_OR_OTHER|||||||0.0342|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||12 months||||0.0342
71739188|NCT01846741|142991057|SUPERIORITY_OR_OTHER|||||||0.5417|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||18 Months||||0.5417
71739189|NCT01817959|142991085|SUPERIORITY||least square mean difference|0.001||||0.9863|TWO_SIDED|99.75|-0.205|0.207||Treatment p value|ANOVA|||||0.207|-0.205|0.9863
71739190|NCT01817959|142991086|SUPERIORITY||least square mean difference|0.024||||0.7115|TWO_SIDED|99.75|-0.184|0.232||Treatment p value|ANOVA|||||0.232|-0.184|0.7115
71739191|NCT01817959|142991087|SUPERIORITY||Odds Ratio, log|0.21||||0.1346|TWO_SIDED|95.0|0.03|1.63||Treatment p value|Regression, Logistic|||Analytical statistics are reported for Day 75 after transplant 2||1.63|0.03|0.1346
71739192|NCT01817959|142991088|SUPERIORITY||Odds Ratio (OR)|0.91||||0.913|TWO_SIDED|95.0|0.17|4.93||Treatment p value|Regression, Logistic|||||4.93|0.17|0.9130
71739193|NCT01817959|142991089|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5467|TWO_SIDED|95.0|0.16|2.66||Treatment p value|Regression, Logistic|||||2.66|0.16|0.5467
71739194|NCT01817959|142991090|SUPERIORITY|||||||0.1383|||||||Fisher Exact|||||||0.1383
71739195|NCT01817959|142991092|SUPERIORITY||least square mean difference|-0.021||||0.6952|TWO_SIDED|95.0|-0.13|0.088||Treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 1)||0.088|-0.130|0.6952
71739196|NCT01817959|142991092|SUPERIORITY||least square mean difference|0.028||||0.556|TWO_SIDED|95.0|-0.068|0.124||This is a treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 2)||0.124|-0.068|0.5560
71739197|NCT01817959|142991092|SUPERIORITY||least square mean difference|0.056||||0.2537|TWO_SIDED|95.0|-0.042|0.154||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.154|-0.042|0.2537
71772362|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0028||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||0.0028
71772363|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from baseline to one-month follow-up"||||<0.0001
71772364|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||1||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||1.0
71772365|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.643||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations is important to my health from post-intervention to one-month follow-up"||||0.6430
71772366|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1193||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||0.1193
71772367|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|||||<|0.0001||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to post-intervention"||||<0.0001
71831463|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.08||0.441|TWO_SIDED|95.0|0.78|1.11|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.78|0.4410
71772368|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4861||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.4861
71831464|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7426|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7426
71831465|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.09||0.7469|TWO_SIDED|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.81|0.7469
71831466|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.09||0.6784|TWO_SIDED|95.0|0.81|1.15|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.81|0.6784
71831467|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.09||0.8822|TWO_SIDED|95.0|0.85|1.21|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.21|0.85|0.8822
71831468|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.09||0.9119|TWO_SIDED|95.0|0.83|1.18|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.18|0.83|0.9119
71831469|NCT02528188|143167460|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5148|TWO_SIDED|95.0|0.89|1.26|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.26|0.89|0.5148
71831470|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.3348|TWO_SIDED|95.0|0.66|1.15|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.15|0.66|0.3348
71831471|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.88|STANDARD_ERROR_OF_MEAN|0.13||0.3595|TWO_SIDED|95.0|0.66|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.16|0.66|0.3595
71831472|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.0854|TWO_SIDED|95.0|0.54|1.04|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.04|0.54|0.0854
71831473|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.69|STANDARD_ERROR_OF_MEAN|0.12||0.0281|TWO_SIDED|95.0|0.5|0.96|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.96|0.50|0.0281
71731859|NCT01541917|142978712|SUPERIORITY_OR_OTHER||Slope|-0.004|STANDARD_ERROR_OF_MEAN|0.008||0.67|TWO_SIDED|95.0|-0.02|0.013|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.013|-.02|.67
71731860|NCT01541917|142978713|SUPERIORITY_OR_OTHER||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.58|TWO_SIDED|95.0|-0.01|0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable||.01|-.01|.58
71731861|NCT01541917|142978713|SUPERIORITY_OR_OTHER||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.007||0.49|TWO_SIDED|95.0|-0.009|0.018|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.||.018|-.009|.49
71831474|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.13||0.0595|TWO_SIDED|95.0|0.49|1.01|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.01|0.49|0.0595
71831475|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.57|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.4|0.83|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||0.83|0.40|0.0030
71831476|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.15||0.1389|TWO_SIDED|95.0|0.48|1.11|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.11|0.48|0.1389
71831477|NCT02528188|143167462|SUPERIORITY||LS Mean Ratio|0.68|STANDARD_ERROR_OF_MEAN|0.14||0.0709|TWO_SIDED|95.0|0.45|1.03|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.||1.03|0.45|0.0709
71831478|NCT02528188|143167471|SUPERIORITY|||||||0.6037|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6037
71831479|NCT02528188|143167471|SUPERIORITY|||||||0.1928|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1928
71831480|NCT02528188|143167471|SUPERIORITY|||||||0.7204|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7204
71831481|NCT02528188|143167471|SUPERIORITY|||||||0.7969|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7969
71831482|NCT02528188|143167471|SUPERIORITY|||||||0.7857|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7857
71731862|NCT01014455|142978717|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
71731863|NCT04728594|142978737|SUPERIORITY||Odds Ratio (OR)|2.11|||<|0.001|TWO_SIDED|95.0|1.65|2.69||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.69|1.65|<.001
71731864|NCT04728594|142978737|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.77|2.87||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||2.87|1.77|<.001
71731865|NCT04728594|142978737|SUPERIORITY||Odds Ratio (OR)|1.07|||<|0.001|TWO_SIDED|95.0|0.88|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with delayed contact as the reference group.||1.30|0.88|<.001
71731866|NCT01378429|142978743|NON_INFERIORITY_OR_EQUIVALENCE|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|LS Mean Difference|7.6|||||TWO_SIDED|95.0|-7.4|22.6||\<0.025 for a one-sided test.|ANCOVA||Difference is calculated as Placebo - Ciclesonide.|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.||22.6|-7.4|
71739198|NCT01817959|142991093|SUPERIORITY||least square mean difference|-7.4||||0.591|TWO_SIDED|95.0|-35.2|20.3||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||20.3|-35.2|0.5910
71731867|NCT01018095|142978760|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.191||0.045|TWO_SIDED|95.0|0.25|1.0|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||1.00|0.25|.045
71831483|NCT02528188|143167471|SUPERIORITY|||||||0.6627|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.6627
71831484|NCT02528188|143167471|SUPERIORITY|||||||0.9867|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.9867
71831485|NCT02528188|143167471|SUPERIORITY|||||||0.819|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.8190
71731868|NCT01018095|142978760|NON_INFERIORITY_OR_EQUIVALENCE|It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.|Risk Ratio (RR)|0.46|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.21|0.98||Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.|Chi-squared|||||0.98|0.21|<0.05
71731869|NCT01018095|142978761|NON_INFERIORITY_OR_EQUIVALENCE|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.46|STANDARD_ERROR_OF_MEAN|0.196|=|0.03|TWO_SIDED|95.0|0.21|0.98|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.||0.98|.21|=0.03
71731870|NCT04075409|142978821|OTHER||LS means ratio|1.426|||||TWO_SIDED|90.0|1.112|1.83|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% Confidence Intervals (CIs) were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.830|1.112|
71731871|NCT04075409|142978821|OTHER||LS means ratio|1.234|||||TWO_SIDED|90.0|0.9619|1.584|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.584|0.9619|
71731872|NCT04075409|142978821|OTHER||LS means ratio|1.156|||||TWO_SIDED|90.0|0.9008|1.483|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.483|0.9008|
71731873|NCT04075409|142978822|OTHER||LS means ratio|2.122|||||TWO_SIDED|90.0|1.706|2.638|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.638|1.706|
71731874|NCT04075409|142978822|OTHER||LS means ratio|1.289|||||TWO_SIDED|90.0|1.037|1.603|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.603|1.037|
71731875|NCT04075409|142978822|OTHER||LS means ratio|1.646|||||TWO_SIDED|90.0|1.323|2.046|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.046|1.323|
71731876|NCT04075409|142978823|OTHER||LS means ratio|2.124|||||TWO_SIDED|90.0|1.709|2.639|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.639|1.709|
71731877|NCT04075409|142978823|OTHER||LS means ratio|1.291|||||TWO_SIDED|90.0|1.039|1.604|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.604|1.039|
71739199|NCT01817959|142991093|SUPERIORITY||least square mean difference|4.2||||0.5966|TWO_SIDED|95.0|-11.8|20.2||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 75 (Transplant 2)||20.2|-11.8|0.5966
71731878|NCT04075409|142978823|OTHER||LS means ratio|1.645|||||TWO_SIDED|90.0|1.324|2.044|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||2.044|1.324|
71731879|NCT04075409|142978826|OTHER||LS means ratio|1.089|||||TWO_SIDED|90.0|0.8859|1.339|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.339|0.8859|
71731880|NCT04075409|142978826|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
71731881|NCT04075409|142978826|OTHER||LS means ratio|1.044|||||TWO_SIDED|90.0|0.8489|1.283|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.283|0.8489|
71731882|NCT04075409|142978827|OTHER||LS means ratio|1.344|||||TWO_SIDED|90.0|1.092|1.653|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.653|1.092|
71731883|NCT04075409|142978827|OTHER||LS means ratio|0.9991|||||TWO_SIDED|90.0|0.812|1.229|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.229|0.8120|
71731884|NCT04075409|142978827|OTHER||LS means ratio|1.345|||||TWO_SIDED|90.0|1.093|1.655|||ANOVA|The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed.||Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation.||1.655|1.093|
71772369|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0002||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from baseline to one-month follow-up"||||0.0002
71772370|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3247||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.3247
71831486|NCT02528188|143167471|SUPERIORITY|||||||0.7284|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.7284
71831487|NCT02528188|143167471|SUPERIORITY|||||||0.1545|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)||||0.1545
71831488|NCT00933400|143167514|EQUIVALENCE|equivalence margin = 0|Percent Difference|0.02|||||TWO_SIDED|95.0|-5.6|5.7||||||Difference in AMI rate. NULL: equal rates of AMI in both Groups.||5.7|-5.6|
71831489|NCT00933400|143167515|EQUIVALENCE|equivalence margin = 0|Difference (rates)|26.8|||||TWO_SIDED|95.0|21.4|32.2||||||Difference in Discharge rates. H0: equal rates of Discharge in both Groups.||32.2|21.4|
71831490|NCT00933400|143167515|EQUIVALENCE|equivalence margin = 0|Difference (percents)|5.6|||||TWO_SIDED|95.0|0.0|11.2|||||exact procedures were used to estimate and compare rates of detection for significant coronary disease|Difference in diagnosis rate of Significant coronary disease at index visit. H0: equal rates in both Groups.||11.2|0.0|
71831491|NCT00933400|143167517|SUPERIORITY||binomial proportion|26.8|||||TWO_SIDED|95.0|21.4|32.2|||||Exact confidence intervals for the difference in proportions|H0: no difference in Patient disposition (Discharge) rates between arms||32.2|21.4|
71831492|NCT00933400|143167519|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|-0.4|||||TWO_SIDED|95.0|-6.0|5.2|||||Exact confidence intervals for the difference in proportions|Compare all cause mortality between groups||5.2|-6.0|
71831493|NCT00933400|143167519|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.5|5.7|||||Exact confidence intervals for the difference in proportions|Compare Cardiac Death between groups||5.7|-5.5|
71831494|NCT00933400|143167519|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|0.1|||||TWO_SIDED|95.0|-5.6|5.9|||||Exact confidence intervals for the difference in proportions|Compare AMI between groups||5.9|-5.6|
71731885|NCT01595581|142978851|OTHER|Mann-Whitney U test for continuous variables and Fisher exact test for categorical variables|Mean Difference (Net)|2.9|STANDARD_DEVIATION|1.5||0.35|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 6 weeks post operative."||||0.35
71731886|NCT01595581|142978851|OTHER||Mean Difference (Net)|2.17|STANDARD_DEVIATION|2.0||0.48|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 12 weeks post operative."||||0.48
71731887|NCT01595581|142978851|OTHER||Mean Difference (Net)|1.08|STANDARD_DEVIATION|15.0||0.74|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Power was estimated for change in lean mass of 3.0 plus or minus 1.5 kg in healthy men receiving testosterone. Using a significance level of 0.05 and a power of 0.80, a sample size of 6 participants per group was calculated.~This statistical analysis applies to lean mass in participants 24 weeks post operative."||||0.74
71731888|NCT01058941|142978870|OTHER||Mean Difference (Net)|-0.42||||0.82|TWO_SIDED|95.0|-3.97|3.13||We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||3.13|-3.97|0.82
71731889|NCT01058941|142978871|OTHER||Mean Difference (Net)|-3.68||||0.001|TWO_SIDED|95.0|-5.9|-1.46||We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.||-1.46|-5.90|0.001
71731890|NCT01274611|142978872|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|0.8|||<|0.01|||||||t-test, 2 sided|||||||<0.01
71731891|NCT01274611|142978873|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|15.0|||>|0.01|||||||t-test, 2 sided|||||||>0.01
71731892|NCT03449433|142978881|SUPERIORITY||Ratio of LS Means|1.04|||||TWO_SIDED|95.0|0.985|1.1||||||||1.10|0.985|
71731893|NCT02739321|142978886|NON_INFERIORITY|Hypothesized benchmark of 30%|Risk Difference (RD)|25.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71731894|NCT02739321|142978887|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||.001
71731895|NCT02739321|142978888|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
71772371|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4627||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement Getting vaccinations can be harmful to my health from post-intervention to one-month follow-up"||||0.4627
71772372|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1244||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.1244
71772373|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0575||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0575
71659035|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|1.13|1.98|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.98|1.13|<0.001
71731896|NCT02739321|142978889|SUPERIORITY||Median Difference (Final Values)|4.09||||0.268|TWO_SIDED||||||Mixed Models Analysis|||||||.268
71731897|NCT02739321|142978890|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.058|TWO_SIDED||||||Mixed Models Analysis|||||||.058
71731898|NCT02739321|142978891|SUPERIORITY||Mean Difference (Final Values)|2.82||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
71731899|NCT02739321|142978892|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||||||.232
71731900|NCT02739321|142978893|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.100
71772374|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7489||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.7489
71772375|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0098||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0098
71831495|NCT00933400|143167519|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|3.0|||||TWO_SIDED|95.0|-5.5|6.0|||||Exact confidence intervals for the difference in proportions|Compare MACE between groups||6.0|-5.5|
71831496|NCT00933400|143167519|EQUIVALENCE|The trial was powered to test the principal hypothesis that the major adverse cardiac event (MACE, including myocardial infarction and cardiac death) rate among patients found not to have significant CAD on CCTA exceeds 1%|binomial proportion|1.3|||||TWO_SIDED|95.0|-4.4|7.0|||||Exact confidence intervals for the difference in proportions|Compare Revascularization between groups||7.0|-4.4|
71889033|NCT02649634|143299031|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
71731901|NCT02739321|142978894|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
71731902|NCT02739321|142978895|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
71731903|NCT02739321|142978896|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.040
71731904|NCT02739321|142978897|SUPERIORITY|||||||0.471|||||||Mixed Models Analysis|||||||0.471
71731905|NCT02739321|142978898|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||||||0.015
71731906|NCT02739321|142978899|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71731907|NCT02739321|142978900|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of mattress technology was 5.61 (SE = 0.25).|||
71731908|NCT02739321|142978901|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of actigraph watch was 5.51 (SE = 0.13).|||
71731909|NCT02739321|142978902|NON_INFERIORITY|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely difficult, 7 = extremely easy) that was used to rate ease of use.|||||||||||||||||The mean rating of parent reported ease of us of the mattress technology was 6.04 (SE = 0.15).|||
71731910|NCT02739321|142978903|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
71731911|NCT01345682|142978906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.792||||0.0257|TWO_SIDED|95.0|0.643|0.977||Log-rank test stratified by baseline Eastern Cooperative Oncology Group (ECOG) Performance score (PS)(0 or 1) and prior use of Epidermal Growth Factor Receptor (EGFR)-targeted antibody in the Recurrent and/or Metastatic (R/M) setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.977|0.643|0.0257
71731912|NCT01345682|142978907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.6755|TWO_SIDED|95.0|0.786|1.169||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||1.169|0.786|0.6755
71731913|NCT01345682|142978908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.101|TWO_SIDED|95.0|0.88|4.14|||Regression, Logistic||"Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||4.14|0.88|0.1010
71731914|NCT01345682|142978909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0353|TWO_SIDED|95.0|1.03|2.26|||Regression, Logistic||"Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||2.26|1.03|0.0353
71731915|NCT01345682|142978911|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.01||0.03|TWO_SIDED|95.0|-8.31|-0.42||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score (PS) and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||-0.42|-8.31|0.0300
71731916|NCT01345682|142978912|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|2.16||0.9773|TWO_SIDED|95.0|-4.3|4.18||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.18|-4.30|0.9773
71731917|NCT01345682|142978913|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7767|TWO_SIDED|95.0|-3.28|4.39||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR-targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).||4.39|-3.28|0.7767
71731918|NCT01345682|142978914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.494|TWO_SIDED|95.0|0.717|1.99|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.990|0.717|0.494
71889034|NCT02649634|143299032|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
71889035|NCT02649634|143299033|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
71889036|NCT02649634|143299034|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales||||>.05
71889037|NCT02649634|143299035|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales||||>.05
71889038|NCT02649634|143299036|NON_INFERIORITY_OR_EQUIVALENCE|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales||||>.05
71889039|NCT01486199|143299037|EQUIVALENCE|alpha=0.05||||||0.002|||||||t-test, 2 sided|||Comparing absorptive clearance in CF children vs adult controls||||0.002
71731919|NCT01345682|142978915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.584|TWO_SIDED|95.0|0.687|1.95|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.950|0.687|0.584
71889040|NCT01486199|143299038|EQUIVALENCE|alpha = 0.05||||||0.2|||||||t-test, 2 sided|||Comparison of mucociliary clearance in CF children compared to healthy adults||||0.20
71889041|NCT01486199|143299039|EQUIVALENCE|alpha=0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparing absorptive clearance at t=0 vs t=2 years in pediatric CF subjects||||0.24
71889042|NCT01486199|143299040|EQUIVALENCE|alpha=0.05||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparing mucociliary clearance at t=0 and t=2yrs in pediatric CF subjects||||0.87
71889043|NCT02211261|143299052|OTHER||Percentage of Test relative to Reference|17.66|||||TWO_SIDED|90.0|8.44|36.95|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||36.95|8.44|
71889044|NCT02211261|143299052|OTHER||Percentage of Test relative to Reference|32.73|||||TWO_SIDED|90.0|21.64|49.51|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||49.51|21.64|
71889045|NCT02211261|143299052|OTHER||Percentage of Test relative to Reference|35.02|||||TWO_SIDED|90.0|23.6|51.95|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||51.95|23.60|
71889046|NCT02211261|143299052|OTHER||Percentage of Test relative to Reference|53.18|||||TWO_SIDED|90.0|36.36|77.78|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.78|36.36|
71889047|NCT02211261|143299054|OTHER||Percentage of Test relative to Reference|7.32|||||TWO_SIDED|90.0|4.7|11.4|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||11.40|4.70|
71889048|NCT02211261|143299054|OTHER||Percentage of Test relative to Reference|32.19|||||TWO_SIDED|90.0|20.67|50.12|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||50.12|20.67|
71731920|NCT01345682|142978916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.816|TWO_SIDED|95.0|0.657|1.705|||Regression, Logistic||Odds ratio, 95% CI and p-value (two-sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate|||1.705|0.657|0.816
71731921|NCT01345682|142978917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0217|TWO_SIDED|95.0|0.55|0.96||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|||0.96|0.55|0.0217
71889049|NCT02211261|143299054|OTHER||Percentage of Test relative to Reference|34.43|||||TWO_SIDED|90.0|22.57|52.52|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||52.52|22.57|
71889050|NCT02211261|143299054|OTHER||Percentage of Test relative to Reference|51.47|||||TWO_SIDED|90.0|34.26|77.31|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.|||77.31|34.26|
71889051|NCT03094195|143299118|SUPERIORITY||least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.689|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.9|-1.3|0.689
71659036|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.017
71739200|NCT01817959|142991093|SUPERIORITY||least square mean difference|6.1||||0.5005|TWO_SIDED|95.0|-12.1|24.4||Treatment p value|ANCOVA|||This is the analytic statics for Day 365 (last Transplant)||24.4|-12.1|0.5005
71659037|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|||<|0.001|TWO_SIDED|95.0|0.77|1.37|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.37|0.77|<0.001
71889052|NCT03094195|143299118|SUPERIORITY||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.54||0.35|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689||||0.6|-1.6|0.350
71889053|NCT03094195|143299122|SUPERIORITY||Odds Ratio (OR)|0.9||||0.908|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.908
71889054|NCT03094195|143299122|SUPERIORITY||Odds Ratio (OR)|1.4||||0.609|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.609
71731922|NCT01345682|142978918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.004|TWO_SIDED|95.0|0.5|0.89||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.89|0.50|0.0040
71731923|NCT01345682|142978919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0268|TWO_SIDED|95.0|0.56|0.97||Log-rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR-targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"|||0.97|0.56|0.0268
71731924|NCT00897390|142978923|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.042|||||TWO_SIDED|90.0|1.009|1.075||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.075|1.009|
71731925|NCT00897390|142978923|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.988|||||TWO_SIDED|90.0|0.958|1.019||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.019|0.958|
71731926|NCT00897390|142978925|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.045|||||TWO_SIDED|90.0|1.013|1.077||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.077|1.013|
71731927|NCT00897390|142978925|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.992|||||TWO_SIDED|90.0|0.962|1.022||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.022|0.962|
71739201|NCT01817959|142991094|SUPERIORITY||least square mean difference|0.21||||0.3253|TWO_SIDED|95.0|-0.21|0.63||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)||0.63|-0.21|0.3253
71739202|NCT01817959|142991094|SUPERIORITY||least square mean difference|0.16||||0.6069|TWO_SIDED|95.0|-0.46|0.78||Treatment p value|least square mean difference|||This is the analytic statics for Day 75 (Transplant 2)||0.78|-0.46|0.6069
71739203|NCT01817959|142991094|SUPERIORITY||Least square mean difference|0.17||||0.6437|TWO_SIDED|95.0|-0.56|0.93||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)||0.93|-0.56|0.6437
71889055|NCT03094195|143299123|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.3|3.2|||Regression, Logistic|||||3.2|0.3|0.800
71889056|NCT03094195|143299123|SUPERIORITY||Odds Ratio (OR)|1.4||||0.653|TWO_SIDED|95.0|0.4|4.5|||Regression, Logistic|||||4.5|0.4|0.653
71889057|NCT03094195|143299125|SUPERIORITY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.49||0.225|TWO_SIDED|95.0|-0.4|1.6|||ANCOVA|||||1.6|-0.4|0.225
71889058|NCT03094195|143299125|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.53||0.914|TWO_SIDED|95.0|-1.0|1.1|||ANCOVA|||||1.1|-1.0|0.914
71889059|NCT02440581|143299135|OTHER|T-tests||||||0.443|||||||t-test, 2 sided|||||||.443
71889060|NCT02440581|143299136|OTHER|T-tests||||||0.49|||||||t-test, 2 sided|||||||.490
71889061|NCT02440581|143299137|OTHER|T-tests|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71659038|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.78|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.78|<0.001
71731928|NCT00897390|142978926|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.077|||||TWO_SIDED|90.0|0.978|1.185||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.185|0.978|
71731929|NCT00897390|142978926|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.987|||||TWO_SIDED|90.0|0.9|1.083||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.083|0.900|
71731930|NCT00897390|142978929|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974|||||TWO_SIDED|90.0|0.921|1.03||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.030|0.921|
71731931|NCT00897390|142978929|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.966||||||90.0|0.915|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.915|
71739204|NCT01817959|142991095|SUPERIORITY||least square mean difference|2.0||||0.429|TWO_SIDED|95.0|-3.0|6.9||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 1)||6.9|-3.0|0.4290
71739205|NCT01817959|142991095|SUPERIORITY||least square mean difference|1.0||||0.7853|TWO_SIDED|95.0|-6.3|8.3||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 2)||8.3|-6.3|0.7853
71739206|NCT01817959|142991095|SUPERIORITY||least square mean difference|1.9||||0.6583|TWO_SIDED|95.0|-6.6|10.4||Treatment p value|ANCOVA|||This is the analytic statistics for Day 365 (last Transplant)||10.4|-6.6|0.6583
71772376|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1797||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1797
71831497|NCT02299375|143167538|SUPERIORITY_OR_OTHER||Adjusted median|1.04|STANDARD_DEVIATION|0.28|||TWO_SIDED|95.0|0.63|1.73|||||Data presented above are for 95% equal-tailed credible intervals. The estimated posterior probability that the true ratio losmapimod/placebo is \<1 assuming noninformative priors is 0.44.The estimated posterior probability that the true ratio losmapi|||1.73|0.63|
71831498|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.371|TWO_SIDED|95.0|-0.031|0.084||Analysis performed using a Mixed-effect Model Repeated Measures (MMRM) with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 2|||0.084|-0.031|0.371
71831499|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.244|TWO_SIDED|95.0|-0.024|0.093||Analysis performed using a Mixed-effect Repeated Measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 4|||0.093|-0.024|0.244
71831500|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.05|TWO_SIDED|95.0|0.0|0.119||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 8|||0.119|-0.000|0.050
71831501|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.942|TWO_SIDED|95.0|-0.063|0.058||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 12|||0.058|-0.063|0.942
71659039|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.026|TWO_SIDED|95.0|0.06|0.91|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.06|0.026
71889062|NCT02440581|143299138|OTHER|T-Tests||||||0.083|||||||t-test, 2 sided|||||||.083
71889063|NCT02440581|143299139|OTHER|T-tests||||||0.283|||||||t-test, 2 sided|||||||.283
71889064|NCT02022826|143299140|OTHER||percentage of agreement|76.0||||0.0052|TWO_SIDED|95.0|69.0|83.0|||McNemar|||||83|69|0.0052
71889065|NCT02022826|143299141|OTHER||precentage of agreement|92.0||||1|TWO_SIDED|95.0|87.0|96.0|||McNemar|||||96|87|1.00
71889066|NCT02863068|143299142|SUPERIORITY|||||||0.2967||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS for all participants between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for all participants.||||0.2967
71731932|NCT00897390|142978930|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.962||||||90.0|0.906|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.020|0.906|
71731933|NCT00897390|142978930|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974||||||90.0|0.92|1.032||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.032|0.920|
71731934|NCT00897390|142978931|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.937|||||TWO_SIDED|90.0|0.864|1.016||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.016|0.864|
71739207|NCT01817959|142991099|SUPERIORITY||Least square mean difference|0.0||||0.9949|TWO_SIDED|95.0|-1.28|1.28||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||1.28|-1.28|0.9949
71739208|NCT01817959|142991099|SUPERIORITY||Least square mean difference|0.1||||0.8753|TWO_SIDED|95.0|-1.18|1.38||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||1.38|-1.18|0.8753
71739209|NCT01817959|142991099|SUPERIORITY||Least square mean difference|-0.59||||0.3955|TWO_SIDED|95.0|-1.97|0.8||Treatment p value|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.80|-1.97|0.3955
71739210|NCT01817959|142991100|SUPERIORITY||Least square mean difference|-0.105||||0.2444|TWO_SIDED|95.0|-0.286|0.075||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)||0.075|-0.286|0.2444
71772377|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.3613||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my doctor to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.3613
71889067|NCT02863068|143299143|SUPERIORITY|||||||0.2818||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS)||||0.2818
71889068|NCT02863068|143299143|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms||||1.0
71889069|NCT02863068|143299144|SUPERIORITY|||||||0.3754||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms using a Wilcoxon signed rank test|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS)||||0.3754
71889070|NCT02863068|143299146|SUPERIORITY|||||||0.1165||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.1165
71889071|NCT02863068|143299146|SUPERIORITY|||||||0.4583||||||A matched pairs design was employed to test for changes in methemoglobin at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in methemoglobin from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.4583
71889072|NCT02863068|143299147|SUPERIORITY|||||||0.068||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.068
71659040|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.01|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.01|0.42|<0.001
71659041|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|||<|0.001|TWO_SIDED|95.0|0.84|1.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.84|<0.001
71659042|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.017|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.017
71659043|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.6|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.60|<0.001
71659044|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.48|1.33|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.48|<0.001
71659045|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.089|TWO_SIDED|95.0|-0.06|0.8|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.80|-0.06|0.089
71659046|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.83|0.24|<0.001
71659047|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|||<|0.001|TWO_SIDED|95.0|0.6|1.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.44|0.60|<0.001
71659048|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
71659049|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|||<|0.001|TWO_SIDED|95.0|0.42|1.02|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.02|0.42|<0.001
71659050|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67||||0.002|TWO_SIDED|95.0|0.25|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.25|0.002
71659051|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.163|TWO_SIDED|95.0|-0.12|0.72|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.72|-0.12|0.163
71831502|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.127|TWO_SIDED|95.0|-0.014|0.114||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 18|||0.114|-0.014|0.127
71659052|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.016|TWO_SIDED|95.0|0.07|0.66|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.07|0.016
71659053|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68||||0.002|TWO_SIDED|95.0|0.26|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.26|0.002
71659054|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.496|TWO_SIDED|95.0|-0.19|0.4|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.19|0.496
71659055|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.003|TWO_SIDED|95.0|0.16|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.16|0.003
71659056|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.008|TWO_SIDED|95.0|0.15|1.0|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.00|0.15|0.008
71659057|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.315|TWO_SIDED|95.0|-0.21|0.64|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.21|0.315
71659058|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.019|TWO_SIDED|95.0|0.06|0.66|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|0.06|0.019
71659059|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.038|TWO_SIDED|95.0|0.02|0.87|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.87|0.02|0.038
71659060|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.918|TWO_SIDED|95.0|-0.28|0.31|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.28|0.918
71659061|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.105|TWO_SIDED|95.0|-0.05|0.55|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|-0.05|0.105
71659062|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.045|TWO_SIDED|95.0|0.01|0.85|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.01|0.045
71831503|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.024|TWO_SIDED|95.0|0.011|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 26|||0.148|0.011|0.024
71831504|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.057|TWO_SIDED|95.0|-0.003|0.174||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 39|||0.174|-0.003|0.057
71659063|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.355|TWO_SIDED|95.0|-0.22|0.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.22|0.355
71659064|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.127|TWO_SIDED|95.0|-0.07|0.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.07|0.127
71659065|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.171|TWO_SIDED|95.0|-0.12|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.12|0.171
71659066|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.79|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.25|0.790
71659067|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.235|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.47|-0.12|0.235
71659068|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.236|TWO_SIDED|95.0|-0.16|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.66|-0.16|0.236
71659069|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.599|TWO_SIDED|95.0|-0.3|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.30|0.599
71659070|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.353|TWO_SIDED|95.0|-0.15|0.43|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.15|0.353
71659071|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.293|TWO_SIDED|95.0|-0.19|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.19|0.293
71739211|NCT01817959|142991100|SUPERIORITY||Least square mean difference|-0.218||||0.0328|TWO_SIDED|95.0|-0.417|-0.019||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)||-0.019|-0.417|0.0328
71739212|NCT01817959|142991100|SUPERIORITY||Least square mean difference|-0.177||||0.1059|TWO_SIDED|95.0|-0.393|0.039||This is the analytic statistics for Day 75 (Transplant 2)|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)||0.039|-0.393|0.1059
71739213|NCT02578186|142991130|SUPERIORITY_OR_OTHER|||||||0.0312|||||||ANCOVA|||||||0.0312
71831505|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.481|TWO_SIDED|95.0|-0.09|0.191||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 52|||0.191|-0.090|0.481
71831506|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.014||||0.521|TWO_SIDED|95.0|-0.03|0.059||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 2|||0.059|-0.030|0.521
71831507|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.084|TWO_SIDED|95.0|-0.005|0.086||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 4|||0.086|-0.005|0.084
71831508|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.266|TWO_SIDED|95.0|-0.025|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 8|||0.090|-0.025|0.266
71831509|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.665|TWO_SIDED|95.0|-0.066|0.042||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 12|||0.042|-0.066|0.665
71831510|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023||||0.489|TWO_SIDED|95.0|-0.043|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 18|||0.090|-0.043|0.489
71831511|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.099||||0.007|TWO_SIDED|95.0|0.028|0.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 26|||0.170|0.028|0.007
71831512|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.248|TWO_SIDED|95.0|-0.039|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 39|||0.148|-0.039|0.248
71831513|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043||||0.506|TWO_SIDED|95.0|-0.087|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 52|||0.172|-0.087|0.506
71831514|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051||||0.223|TWO_SIDED|95.0|-0.032|0.134||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 2|||0.134|-0.032|0.223
71889073|NCT02863068|143299147|SUPERIORITY|||||||0.5||||||A matched pairs design was employed to test for changes in total ulcerated surface area at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in total ulcerated surface area from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.5
71889074|NCT02863068|143299147|SUPERIORITY|||||||1|||||||Fisher Exact|Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants on Hydroxyurea (HU).||||1.0
71731935|NCT00897390|142978931|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.964|||||TWO_SIDED|90.0|0.891|1.042||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\] and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.||1.042|0.891|
71731936|NCT01294163|142978943|NON_INFERIORITY_OR_EQUIVALENCE|Xenon was to be concluded non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the prespecified margin of 0.63 ng/mL. Assuming a margin of 0.63, a same concentration of troponin I at 24 hours in the xenon and sevoflurane groups, a common standard deviation of 1.9 ng/mL and a one-sided type I error of 0.025, 164 patients per group were deemed necessary to demonstrate non-inferiority.|Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-1.27|0.47|||ANCOVA|Treatment difference and 95%CI assessed using ANCOVA with 24h troponin I as response, treatment group and pre-induction troponin I as covariates.||||0.47|-1.27|0.02
71731937|NCT01294163|142978952|NON_INFERIORITY_OR_EQUIVALENCE|It was to be concluded that xenon was non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference \[mean troponin I level (xenon) - mean troponin I level (sevoflurane)\] was below the margin of 0.15 ng/mL.|Mean Difference (Final Values)|-0.09||||0.0186|TWO_SIDED|95.0|-0.3|0.11|||ANCOVA|||As the residuals from the primary ANCOVA model were non-normal and skewed, the non-inferiority analysis was repeated using log-transformed blood troponin levels.||0.11|-0.30|0.0186
71731938|NCT00958217|142978953|SUPERIORITY_OR_OTHER||2nd order effects of time (2 slope|33.0|||<|0.05|TWO_SIDED|95.0||||P-values based on likelihood ratio tests for the significance of the first and second order trajectory parameters. Primary tests compared curvilinear trajectories of the two treatment groups.|Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.||||<.05
71731939|NCT00958217|142978954|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|57.0|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|||||<.05
71731940|NCT00958217|142978955|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.43|||<|0.05|TWO_SIDED|95.0|||||Linear Mixed Effects Model|A logit link was used in this model.|We gauged sampling error with 95% confidence bands.|Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.||||<.05
71731941|NCT00958217|142978955|SUPERIORITY_OR_OTHER||Second order effect of time (2 slopes)|0.26|||<|0.05|TWO_SIDED||||||Linear Mixed Effects Model|A logit link was used in this model|We gauged sampling error with 95% confidence bands.|Second statistical analysis evaluates trajectories of heavy drinking (\<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.||||<.05
71731942|NCT02440789|142978976|OTHER|||||||0.56|||||||t-test, 2 sided|paired t-test||||||0.56
71731943|NCT02440789|142978978|OTHER|||||||0.11|||||||t-test, 2 sided|paired t-test||||||0.11
71731944|NCT02440789|142978980|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.||||||0.93
71731945|NCT02440789|142978982|OTHER|||||||0.041|||||||t-test, 2 sided|paired t-test||||||0.041
71731946|NCT02440789|142978985|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
71731947|NCT02440789|142978987|OTHER|||||||0.26|||||||t-test, 2 sided|paired t-test||||||0.26
71889075|NCT02863068|143299147|SUPERIORITY|||||||1|||||||Fisher Exact|Fisher's exact test was used to test for differences in frequencies between treatment arms for participants off Hydroxyurea (HU).||Difference in frequency of 25% total ulcerated surface area reduction between treatment arms for participants off Hydroxyurea (HU).||||1.0
71731948|NCT02440789|142978989|OTHER|||||||0.75|||||||t-test, 2 sided|paired t-test||||||0.75
71731949|NCT02440789|142978991|OTHER|||||||0.97|||||||t-test, 2 sided|paired t-test||||||0.97
71772378|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.5972||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.5972
71731950|NCT02440789|142978993|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
71731951|NCT02440789|142978995|OTHER|||||||0.47|||||||t-test, 2 sided|paired t-test||||||0.47
71731952|NCT02440789|142978997|OTHER|||||||0.72|||||||t-test, 2 sided|paired t-test||||||0.72
71731953|NCT02440789|142978999|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
71731954|NCT02440789|142979001|OTHER|||||||0.7|||||||t-test, 2 sided|paired t-test||||||0.7
71731955|NCT02440789|142979003|OTHER|||||||0.28|||||||t-test, 2 sided|paired t-test||||||0.28
71889076|NCT02863068|143299148|SUPERIORITY|||||||0.4298||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants on Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants on Hydroxyurea (HU).||||0.4298
71889077|NCT02863068|143299148|SUPERIORITY|||||||0.2701||||||A matched pairs design was employed to test for changes in average pain at baseline and EOS between treatment arms for participants off Hydroxyurea (HU) using a Wilcoxon signed rank test.|Wilcoxon (Mann-Whitney)|||Change in average pain from baseline to end of study (EOS) for participants off Hydroxyurea (HU).||||0.2701
71889078|NCT03990870|143299153|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71731956|NCT02440789|142979005|OTHER|||||||0.77|||||||t-test, 2 sided|paired t-test||||||0.77
71731957|NCT02440789|142979007|OTHER|||||||0.93|||||||t-test, 2 sided|paired t-test||||||0.93
71731958|NCT02440789|142979009|OTHER|||||||0.65|||||||t-test, 2 sided|paired t-test||||||0.65
71731959|NCT02440789|142979011|OTHER|||||||0.22|||||||t-test, 2 sided|paired t-test||||||0.22
71731960|NCT02440789|142979013|OTHER|||||||0.031|||||||t-test, 2 sided|paired t-test||||||0.031
71731961|NCT02440789|142979015|OTHER|||||||0.005|||||||t-test, 2 sided|paired t-test||||||0.005
71731962|NCT02440789|142979017|OTHER|||||||0.69|||||||t-test, 2 sided|paired t-test||||||0.69
71889079|NCT03990870|143299156|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
71889080|NCT03990870|143299158|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71889081|NCT01279057|143299159|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|104.085|||||TWO_SIDED|90.0|87.421|124.21||||||||124.210|87.421|
71731963|NCT02440789|142979019|OTHER|||||||0.008|||||||t-test, 2 sided|paired t-test||||||0.008
71731964|NCT02564978|142979031|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.39|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.39
71731965|NCT02564978|142979032|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.48|TWO_SIDED|95.0|-0.06|0.03||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.03|-0.06|0.48
71731966|NCT02564978|142979032|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.15|TWO_SIDED|95.0|-0.24|0.04||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.04|-0.24|0.15
71731967|NCT02564978|142979032|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.15|TWO_SIDED|95.0|-0.09|0.01||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes (Study eye + QFE) together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.01|-0.09|0.15
71731968|NCT02564978|142979033|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.61|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.61
71739214|NCT02669121|142991142|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|99.99|-13.181|0.997|||||||The vaccine efficacy was met if lower bound of confidence interval (CI) for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the Cox proportional hazard (PH) model. The 99.99% CI for the VE was obtained by taking 1 minus the 99.99% CI of the hazard ratio from the PH model.|0.997|-13.181|
71739215|NCT02669121|142991143|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.01|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95.01% CI for the VE was obtained by taking 1 minus the 95.01% CI of the hazard ratio from the PH model.|0.816|0.208|
71739216|NCT02669121|142991144|SUPERIORITY||Cox Proportional Hazard|0.618|||||TWO_SIDED|95.0|0.208|0.816|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.816|0.208|
71731969|NCT02564978|142979033|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08||0.43|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||The estimate was the difference in rates of change in mean of appropriately transformed GA area between the treatment phase and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on qualifying fellow eyes alone. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.43
71731970|NCT02564978|142979033|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.89|TWO_SIDED|||||Result of statistical analyses were considered significant if the p-value from the one-sided test was \<0.025. No adjustments for multiplicity were made.|Mixed Models Analysis||Study eye + QFE: study \& qualifying fellow eyes analyzed as separate observations. Estimate: difference in rate of change in mean of appropriately transformed GA area between treatment and run-in phase.|Analysis: linear spline regression with fixed knot @ Month 9 on study and qualifying fellow eyes together. Null hypothesis: difference in rates of change in mean of square-root transformed GA area between treatment phase \& run-in phase \>= 0. Square root transformation used to satisfy the linear trend assumption. Missing values: treated as missing completely at random. Covariance structure of random effect that provided best model fit chosen (Spatial Power). One-sided Type I error rate: 2.5%.||||0.89
71731971|NCT02564978|142979034|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.44|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.44
71731972|NCT02564978|142979034|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.21|TWO_SIDED|95.0|-0.8|0.2||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.2|-0.8|0.21
71731973|NCT02564978|142979034|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.52|TWO_SIDED|95.0|-0.4|0.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in BCVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.8|-0.4|0.52
71731974|NCT02564978|142979035|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.48|TWO_SIDED|95.0|-0.4|0.9||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.9|-0.4|0.48
71659072|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.986|TWO_SIDED|95.0|-0.28|0.28|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.28|0.986
71731975|NCT02564978|142979035|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.09|TWO_SIDED|95.0|-0.9|0.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.1|-0.9|0.09
71772379|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.024||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.0240
71772380|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2437||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.2437
71889082|NCT01279057|143299160|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71659073|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.459|TWO_SIDED|95.0|-0.18|0.39|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|-0.18|0.459
71659074|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.287|TWO_SIDED|95.0|-0.18|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.62|-0.18|0.287
71659075|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.6|TWO_SIDED|95.0|-0.3|0.51|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.30|0.600
71659076|NCT02912650|142833425|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.447|TWO_SIDED|95.0|-0.17|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.17|0.447
71731976|NCT02564978|142979035|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.54|TWO_SIDED|95.0|-0.4|0.7||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rates of change in LLVA between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||0.7|-0.4|0.54
71731977|NCT02564978|142979036|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.2|TWO_SIDED|95.0|-0.4|1.8||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on study eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||1.8|-0.4|0.20
71731978|NCT02564978|142979036|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.02|TWO_SIDED|95.0|0.4|3.1||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided|||Analysis: two-sided Student's paired t-test on qualifying fellow eyes alone. Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||3.1|0.4|0.02
71731979|NCT02564978|142979036|SUPERIORITY|Number of eyes contributing to this analysis exceeds the number of eyes contributing to the study eye only analysis since one participant had relevant data for the qualifying fellow eye but not the study eye.|Mean Difference (Final Values)|1.0||||0.06|TWO_SIDED|95.0|0.0|2.0||Result of statistical analyses were considered significant if the p-value from the two-sided Student's paired t-test was \<0.05. No adjustments for multiplicity were made.|t-test, 2 sided||No. of units analyzed = no. of study eyes + no. qualifying fellow eyes (QFE). However, the value contributing to analysis is the avg. of study eye \& QFE from a participant if both values are available, otherwise equal to eye with data available.|Analysis: two-sided Student's paired t-test on study and qualifying fellow eyes together (Study eye + QFE). Null hypothesis: difference in the mean rate of change of central retinal thickness as measured on OCT between the treatment phase and run-in phase is not equal to 0. Missing values: treated as missing completely at random. Two-sided Type I error rate: 5%.||2.0|0.0|0.06
71731980|NCT01307462|142979107|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based physical functioning score||||.81
71731981|NCT01307462|142979107|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-physical score||||.18
71731982|NCT01307462|142979107|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based bodily pain score||||.48
71731983|NCT01307462|142979107|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based general health score||||.26
71731984|NCT01307462|142979107|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based vitality score||||.23
71731985|NCT01307462|142979107|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based social functioning score||||.36
71731986|NCT01307462|142979107|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-emotional score||||.41
71731987|NCT01307462|142979107|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based mental health score||||.80
71731988|NCT01307462|142979107|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized physical component score||||.80
71731989|NCT01307462|142979107|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized mental component score||||.23
71731990|NCT01307462|142979108|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||FACT physical well-being||||0.28
71772381|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0631||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0631
71772382|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.054||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.0540
71731991|NCT01307462|142979108|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||FACT social/family well-being||||0.1
71731992|NCT01307462|142979108|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||FACT emotional well-being||||0.63
71731993|NCT01307462|142979108|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||FACT functional well-being||||0.78
71731994|NCT01307462|142979108|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||FACT BMT subscale||||.84
71731995|NCT01307462|142979108|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||FACT trial outcome index||||.37
71731996|NCT01307462|142979108|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||FACT-G||||.71
71731997|NCT01307462|142979108|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||FACT-BMT total||||.54
71731998|NCT01307462|142979109|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||HAP maximum activity score - highest item still doing||||.37
71731999|NCT01307462|142979109|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||HAP adjusted activity score - MAS minus stopped||||.39
71732000|NCT01307462|142979109|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Modified HAP adjusted activity score||||.39
71732001|NCT01307462|142979110|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Lee symptom skin scale||||.11
71889083|NCT01279057|143299160|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71889084|NCT01279057|143299161|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|106.635|||||TWO_SIDED|90.0|89.256|127.79||||||||127.790|89.256|
71659077|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.001|TWO_SIDED|95.0|0.23|0.96|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|0.23|0.001
71659078|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.297|TWO_SIDED|95.0|-0.12|0.39|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.39|-0.12|0.297
71732002|NCT01307462|142979110|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Lee symptom energy scale||||.007
71732003|NCT01307462|142979110|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Lee symptom lung scale||||.20
71732004|NCT01307462|142979110|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom eye scale||||.002
71732005|NCT01307462|142979110|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Lee symptom nutrition scale||||.52
71732006|NCT01307462|142979110|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Lee symptom psychological scale||||.22
71732007|NCT01307462|142979110|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom mouth scale||||.002
71732008|NCT01307462|142979110|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Lee symptom overall summary scale||||<0.001
71732009|NCT03875664|142979120|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71732010|NCT04253587|142979123|EQUIVALENCE|The null hypothesis was no difference between mean change scores for time-points X conditions.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03|=|0.016|TWO_SIDED|95.0|-0.06|0.06||Mixed effects ANOVA applied family wise error for post-hoc tests according to a priori hypothesis|ANOVA|||||0.06|-0.06|= 0.016
71732011|NCT04253587|142979124|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|=|0.22|TWO_SIDED|95.0|-0.03|0.03|||ANOVA|effect of condition (F1,20 = 1.616, p = 0.22), effect of time (F1,20 = 0.613, p = 0.44)||||0.03|-0.03|= 0.22
71732012|NCT01885910|142979138|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
71732013|NCT05160766|142979149|OTHER||Difference of means in percent|12.557|STANDARD_ERROR_OF_MEAN|5.661||0.03143|TWO_SIDED|95.0|1.168|23.946|||ANCOVA|||The statistical analysis reflects Part A of the study.||23.946|1.168|0.03143
71732014|NCT05160766|142979149|OTHER||Difference of means in percent|4.331|STANDARD_ERROR_OF_MEAN|1.671||0.0101|TWO_SIDED|95.0|1.04|7.621|||ANCOVA|||This statistical analysis reflects Part B of the study.||7.621|1.04|0.0101
71732015|NCT05160766|142979150|OTHER||Difference of means in percent|12.168|STANDARD_ERROR_OF_MEAN|5.88||0.04405|TWO_SIDED|95.0|0.338|23.998|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|23.998|0.338|0.04405
71732016|NCT05160766|142979150|OTHER||Difference of means in percent|14.212|STANDARD_ERROR_OF_MEAN|5.767||0.01744|TWO_SIDED|95.0|2.61|25.814|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|25.814|2.61|0.01744
71659079|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.457|TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.16|-0.35|0.457
71772383|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7298||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust my pharmacist to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7298
71831515|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046||||0.276|TWO_SIDED|95.0|-0.037|0.129||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 4|||0.129|-0.037|0.276
71732017|NCT05160766|142979150|OTHER||Difference of means in percent|14.239|STANDARD_ERROR_OF_MEAN|5.932||0.02039|TWO_SIDED|95.0|2.305|26.173|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|26.173|2.305|0.02039
71732018|NCT05160766|142979150|OTHER||Difference of means in percent|9.331|STANDARD_ERROR_OF_MEAN|4.636||0.04989|TWO_SIDED|95.0|0.005|18.656|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|18.656|0.005|0.04989
71732019|NCT05160766|142979150|OTHER||Difference of means in percent|10.312|STANDARD_ERROR_OF_MEAN|4.373||0.02259|TWO_SIDED|95.0|1.514|19.111|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|19.111|1.514|0.02259
71732020|NCT05160766|142979150|OTHER||Difference of means in percent|11.601|STANDARD_ERROR_OF_MEAN|4.634||0.01583|TWO_SIDED|95.0|2.279|20.924|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|20.924|2.279|0.01583
71732021|NCT05160766|142979150|OTHER||Difference of means in percent|11.863|STANDARD_ERROR_OF_MEAN|4.323||0.00856|TWO_SIDED|95.0|3.166|20.56|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|20.56|3.166|0.00856
71732022|NCT05160766|142979150|OTHER||Difference of means in percent|6.83|STANDARD_ERROR_OF_MEAN|2.244||0.00258|TWO_SIDED|95.0|2.41|11.249|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|11.249|2.41|0.00258
71732023|NCT05160766|142979150|OTHER||Difference of means in percent|6.048|STANDARD_ERROR_OF_MEAN|2.244||0.00748|TWO_SIDED|95.0|1.63|10.466|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|10.466|1.63|0.00748
71732024|NCT05160766|142979150|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|2.782||0.00922|TWO_SIDED|95.0|1.821|12.782|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.782|1.821|0.00922
71732025|NCT05160766|142979150|OTHER||Difference of means in percent|4.791|STANDARD_ERROR_OF_MEAN|2.646||0.07136|TWO_SIDED|95.0|-0.419|10.001|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|10.001|-0.419|0.07136
71659080|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.012|TWO_SIDED|95.0|0.1|0.82|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.82|0.10|0.012
71659081|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.33|1.06|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|0.33|<0.001
71659082|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23||||0.076|TWO_SIDED|95.0|-0.49|0.02|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.02|-0.49|0.076
71732026|NCT05160766|142979150|OTHER||Difference of means in percent|3.965|STANDARD_ERROR_OF_MEAN|2.196||0.07218|TWO_SIDED|95.0|-0.36|8.29|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|8.29|-0.36|0.07218
71732027|NCT05160766|142979150|OTHER||Difference of means in percent|4.82|STANDARD_ERROR_OF_MEAN|2.202||0.02949|TWO_SIDED|95.0|0.484|9.155|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|9.155|0.484|0.02949
71732028|NCT05160766|142979150|OTHER||Difference of means in percent|3.926|STANDARD_ERROR_OF_MEAN|2.263||0.08403|TWO_SIDED|95.0|-0.531|8.382|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|8.382|-0.531|0.08403
71732029|NCT05160766|142979153|OTHER||Difference of means in percent|8.835|STANDARD_ERROR_OF_MEAN|11.03||0.42797|TWO_SIDED|95.0|-13.475|31.145|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|31.145|-13.475|0.42797
71732030|NCT05160766|142979153|OTHER||Difference of means in percent|3.54|STANDARD_ERROR_OF_MEAN|10.575||0.73961|TWO_SIDED|95.0|-17.85|24.929|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.351 (beta)."|24.929|-17.85|0.73961
71732031|NCT05160766|142979153|OTHER||Difference of means in percent|8.086|STANDARD_ERROR_OF_MEAN|10.683||0.4537|TWO_SIDED|95.0|-13.524|29.695|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.1 (gamma)."|29.695|-13.524|0.45370
71732032|NCT05160766|142979153|OTHER||Difference of means in percent|1.636|STANDARD_ERROR_OF_MEAN|10.187||0.87323|TWO_SIDED|95.0|-18.969|22.241|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.1 (omicron)."|22.241|-18.969|0.87323
71732033|NCT05160766|142979153|OTHER||Difference of means in percent|0.81|STANDARD_ERROR_OF_MEAN|9.848||0.93489|TWO_SIDED|95.0|-19.109|20.728|||ANCOVA|||This statistical analysis relfects Part A of the study.|"The above provided values refer to the variant BA.4 (omicron)."|20.728|-19.109|0.93489
71732034|NCT05160766|142979153|OTHER||Difference of means in percent|3.511|STANDARD_ERROR_OF_MEAN|10.845||0.74784|TWO_SIDED|95.0|-18.425|25.448|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|25.448|-18.425|0.74784
71732035|NCT05160766|142979153|OTHER||Difference of means in percent|2.088|STANDARD_ERROR_OF_MEAN|10.409||0.84202|TWO_SIDED|95.0|-18.966|23.143|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.5 (omicron)."|23.143|-18.966|0.84202
71732036|NCT05160766|142979153|OTHER||Difference of means in percent|5.807|STANDARD_ERROR_OF_MEAN|4.068||0.15477|TWO_SIDED|95.0|-2.207|13.821|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.1.7 (alpha)."|13.821|-2.207|0.15477
71831516|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.075||||0.131|TWO_SIDED|95.0|-0.023|0.173||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 8|||0.173|-0.023|0.131
71659083|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.03|||<|0.001|TWO_SIDED|95.0|1.42|2.63|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.63|1.42|<0.001
71889085|NCT01279057|143299162|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71659084|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.016|TWO_SIDED|95.0|0.1|0.93|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.93|0.10|0.016
71732037|NCT05160766|142979153|OTHER||Difference of means in percent|3.52|STANDARD_ERROR_OF_MEAN|3.984||0.37773|TWO_SIDED|95.0|-4.327|11.368|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.351 (beta)."|11.368|-4.327|0.37773
71732038|NCT05160766|142979153|OTHER||Difference of means in percent|4.413|STANDARD_ERROR_OF_MEAN|4.18||0.29212|TWO_SIDED|95.0|-3.821|12.647|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.1 (gamma)."|12.647|-3.821|0.29212
71732039|NCT05160766|142979153|OTHER||Difference of means in percent|5.961|STANDARD_ERROR_OF_MEAN|4.04||0.1414|TWO_SIDED|95.0|-1.998|13.919|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.1 (omicron)."|13.919|-1.998|0.14140
71732040|NCT05160766|142979153|OTHER||Difference of means in percent|2.199|STANDARD_ERROR_OF_MEAN|3.875||0.5709|TWO_SIDED|95.0|-5.434|9.832|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4 (omicron)."|9.832|-5.434|0.57090
71732041|NCT05160766|142979153|OTHER||Difference of means in percent|6.528|STANDARD_ERROR_OF_MEAN|4.071||0.11012|TWO_SIDED|95.0|-1.491|14.548|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.4.6 (omicron)."|14.548|-1.491|0.11012
71732042|NCT05160766|142979153|OTHER||Difference of means in percent|4.239|STANDARD_ERROR_OF_MEAN|4.06||0.29755|TWO_SIDED|95.0|-3.759|12.237|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.5 (omicron)."|12.237|-3.759|0.29755
71889086|NCT01279057|143299162|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71732043|NCT05160766|142979158|OTHER||Difference of means in percent|9.64|STANDARD_ERROR_OF_MEAN|11.191||0.39426|TWO_SIDED|95.0|-12.995|32.275|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant P.2 (gamma)."|32.275|-12.995|0.39426
71732044|NCT05160766|142979158|OTHER||Difference of means in percent|8.764|STANDARD_ERROR_OF_MEAN|10.765||0.42055|TWO_SIDED|95.0|-13.011|30.539|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617."|30.539|-13.011|0.42055
71732045|NCT05160766|142979158|OTHER||Difference of means in percent|8.472|STANDARD_ERROR_OF_MEAN|10.953||0.44391|TWO_SIDED|95.0|-13.683|30.627|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|30.627|-13.683|0.44391
71732046|NCT05160766|142979158|OTHER||Difference of means in percent|8.483|STANDARD_ERROR_OF_MEAN|10.82||0.43775|TWO_SIDED|95.0|-13.402|30.368|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.3 (delta)."|30.368|-13.402|0.43775
71732047|NCT05160766|142979158|OTHER||Difference of means in percent|6.19|STANDARD_ERROR_OF_MEAN|9.892||0.53511|TWO_SIDED|95.0|-13.819|26.2|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|26.2|-13.819|0.53511
71732048|NCT05160766|142979158|OTHER||Difference of means in percent|4.552|STANDARD_ERROR_OF_MEAN|10.801||0.67576|TWO_SIDED|95.0|-17.295|26.399|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.617.3."|26.399|-17.295|0.67576
71732049|NCT05160766|142979158|OTHER||Difference of means in percent|8.438|STANDARD_ERROR_OF_MEAN|11.168||0.45443|TWO_SIDED|95.0|-14.15|31.027|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|31.027|-14.15|0.45443
71732050|NCT05160766|142979158|OTHER||Difference of means in percent|8.901|STANDARD_ERROR_OF_MEAN|10.218||0.38904|TWO_SIDED|95.0|-11.768|29.569|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|29.569|-11.768|0.38904
71732051|NCT05160766|142979158|OTHER||Difference of means in percent|7.302|STANDARD_ERROR_OF_MEAN|10.11||0.47466|TWO_SIDED|95.0|-13.147|27.751|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|27.751|-13.147|0.47466
71732052|NCT05160766|142979158|OTHER||Difference of means in percent|2.878|STANDARD_ERROR_OF_MEAN|9.824||0.7711|TWO_SIDED|95.0|-16.993|22.749|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|22.749|-16.993|0.77110
71732053|NCT05160766|142979158|OTHER||Difference of means in percent|1.753||||0.86646|TWO_SIDED|95.0|-19.195|22.701|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|22.701|-19.195|0.86646
71732054|NCT05160766|142979158|OTHER||Difference of means in percent|5.42|STANDARD_ERROR_OF_MEAN|9.705||0.57972|TWO_SIDED|95.0|-14.21|25.049|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|25.049|-14.21|0.57972
71732055|NCT05160766|142979158|OTHER||Difference of means in percent|1.17|STANDARD_ERROR_OF_MEAN|9.408||0.90166|TWO_SIDED|95.0|-17.859|20.199|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BA.3 (omicron)."|20.199|-17.859|0.90166
71732056|NCT05160766|142979158|OTHER||Difference of means in percent|1.018|STANDARD_ERROR_OF_MEAN|10.44||0.92279|TWO_SIDED|95.0|-20.099|22.136|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BF.7 (omicron)."|22.136|-20.099|0.92279
71772384|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.4218||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.4218
71889087|NCT01279057|143299163|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|115.877|||||TWO_SIDED|90.0|94.129|143.949||||||||143.949|94.129|
71732057|NCT05160766|142979158|OTHER||Difference of means in percent|3.532|STANDARD_ERROR_OF_MEAN|9.496||0.71191|TWO_SIDED|95.0|-15.675|22.74|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|22.74|-15.675|0.71191
71732058|NCT05160766|142979158|OTHER||Difference of means in percent|2.995|STANDARD_ERROR_OF_MEAN|8.755||0.73415|TWO_SIDED|95.0|-14.714|20.703|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|20.703|-14.714|0.73415
71732059|NCT05160766|142979158|OTHER||Difference of means in percent|7.157|STANDARD_ERROR_OF_MEAN|9.548||0.45798|TWO_SIDED|95.0|-12.155|26.469|||ANCOVA|||This statistical analysis reflects Part A of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|26.469|-12.155|0.45798
71732060|NCT05160766|142979158|OTHER||Difference of means in percent|4.819|STANDARD_ERROR_OF_MEAN|4.055||0.23582|TWO_SIDED|95.0|-3.169|12.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant P.2 (gamma)."|12.808|-3.169|0.23582
71732061|NCT05160766|142979158|OTHER||Difference of means in percent|5.312|STANDARD_ERROR_OF_MEAN|4.074||0.19354|TWO_SIDED|95.0|-2.713|13.337|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617."|13.337|-2.713|0.19354
71732062|NCT05160766|142979158|OTHER||Difference of means in percent|5.714|STANDARD_ERROR_OF_MEAN|4.155||0.17033|TWO_SIDED|95.0|-2.471|13.899|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.1 (kappa)."|13.899|-2.471|0.17033
71732063|NCT05160766|142979158|OTHER||Difference of means in percent|5.934|STANDARD_ERROR_OF_MEAN|3.997||0.13895|TWO_SIDED|95.0|-1.94|13.808|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.3 (delta)."|13.808|-1.94|0.13895
71772385|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.2282||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to post-intervention"||||0.2282
71889088|NCT01279057|143299164|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
71659085|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.33|TWO_SIDED|95.0|-0.21|0.64|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.64|-0.21|0.330
71732064|NCT05160766|142979158|OTHER||Difference of means in percent|4.222|STANDARD_ERROR_OF_MEAN|3.812||0.26924|TWO_SIDED|95.0|-3.288|11.732|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant AY.4.2 (delta)."|11.732|-3.288|0.26924
71732065|NCT05160766|142979158|OTHER||Difference of means in percent|5.49|STANDARD_ERROR_OF_MEAN|3.996||0.1708|TWO_SIDED|95.0|-2.382|13.362|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.617.3."|13.362|-2.382|0.17080
71732066|NCT05160766|142979158|OTHER||Difference of means in percent|5.567|STANDARD_ERROR_OF_MEAN|4.188||0.18502|TWO_SIDED|95.0|-2.683|13.818|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant B.1.526.1 (iota)."|13.818|-2.683|0.18502
71732067|NCT05160766|142979158|OTHER||Difference of means in percent|3.438|STANDARD_ERROR_OF_MEAN|3.938||0.38344|TWO_SIDED|95.0|-4.318|11.195|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452M (omicron)."|11.195|-4.318|0.38344
71732068|NCT05160766|142979158|OTHER||Difference of means in percent|3.279|STANDARD_ERROR_OF_MEAN|3.982||0.411|TWO_SIDED|95.0|-4.565|11.124|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2+L452R (omicron)."|11.124|-4.565|0.41100
71732069|NCT05160766|142979158|OTHER||Difference of means in percent|2.67|STANDARD_ERROR_OF_MEAN|4.014||0.5066|TWO_SIDED|95.0|-5.237|10.577|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.12.1 (omicron)."|10.577|-5.237|0.50660
71732070|NCT05160766|142979158|OTHER||Difference of means in percent|4.535|STANDARD_ERROR_OF_MEAN|4.242||0.28604|TWO_SIDED|95.0|-3.82|12.891|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75 (omicron)."|12.891|-3.82|0.28604
71732071|NCT05160766|142979158|OTHER||Difference of means in percent|6.259|STANDARD_ERROR_OF_MEAN|3.98||0.11715|TWO_SIDED|95.0|-1.582|14.1|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.2.75.2 (omicron)."|14.1|-1.582|0.11715
71772386|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.8711||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.8711
71772387|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.0027||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from baseline to one-month follow-up"||||0.0027
71772388|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.7579||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.7579
71772389|NCT03239665|143044899|EQUIVALENCE|Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)||||||0.1299||||||Wilcoxon Signed-Rank test with a Bonferroni-corrected significance threshold of alpha = 0.0167 (3 comparisons)|Sign test|||"Testing within-group changes in beliefs for the statement I trust a peer educator to give me information about vaccines and the diseases they prevent from post-intervention to one-month follow-up"||||0.1299
71772390|NCT03239665|143044901|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program immediately post-intervention via Fisher's Exact test||||1.0
71659086|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.91|2.11|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.11|0.91|<0.001
71732072|NCT05160766|142979158|OTHER||Difference of means in percent|3.818|STANDARD_ERROR_OF_MEAN|3.957||0.33567|TWO_SIDED|95.0|-3.978|11.613|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BA.3 (omicron)."|11.613|-3.978|0.33567
71732073|NCT05160766|142979158|OTHER||Difference of means in percent|5.775|STANDARD_ERROR_OF_MEAN|4.022||0.15232|TWO_SIDED|95.0|-2.147|13.697|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BF.7 (omicron)."|13.697|-2.147|0.15232
71659087|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.21|2.42|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|1.21|<0.001
71732074|NCT05160766|142979158|OTHER||Difference of means in percent|4.808|STANDARD_ERROR_OF_MEAN|3.845||0.21234|TWO_SIDED|95.0|-2.766|12.383|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1 (omicron)."|12.383|-2.766|0.21234
71732075|NCT05160766|142979158|OTHER||Difference of means in percent|4.58|STANDARD_ERROR_OF_MEAN|3.78||0.22687|TWO_SIDED|95.0|-2.866|12.026|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant BQ.1.1 (omicron)."|12.026|-2.866|0.22687
71772391|NCT03239665|143044901|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.6806||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous engagement in the program at the one-month follow-up via Fisher's Exact test||||0.6806
71889089|NCT01279057|143299164|SUPERIORITY|||||||0.0441|||||||ANCOVA|||||||0.0441
71732076|NCT05160766|142979158|OTHER||Difference of means in percent|3.498|STANDARD_ERROR_OF_MEAN|4.047||0.38832|TWO_SIDED|95.0|-4.475|11.47|||ANCOVA|||This statistical analysis reflects Part B of the study.|"The above provided values refer to the variant XBB.1 (omicron)."|11.47|-4.475|0.38832
71732077|NCT02753127|142979174|SUPERIORITY||Hazard Ratio (HR)|0.976||||0.3629|TWO_SIDED|95.0|0.854|1.117||1-sided|Log Rank|Based on stratified log-rank test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|"Based on Cox Proportional hazards model stratified by actual stratification factors including Time to progression on 1st line therapy, RAS mutation, and Bev as part of study treatment.~A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.117|0.854|0.3629
71732078|NCT02753127|142979174|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.3782|TWO_SIDED|95.0|0.797|1.179||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p value without multiplicity adjustment.|Hazard Ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin+ FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.179|0.797|0.3782
71732079|NCT02753127|142979175|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7307|TWO_SIDED|95.0|0.917|1.18||1-sided|Log Rank|"Based on stratified log rank test stratified by actual stratification factors~. P-value is nominal p-value without multiplicity adjustment."|"Based on Cox Proportional hazards model stratified by actual stratification~. A HR \<1 indicates a lower risk with Arm 1 compared with Arm 2."|General population||1.180|0.917|0.7307
71732080|NCT02753127|142979175|SUPERIORITY||Hazard Ratio (HR)|1.064||||0.7434|TWO_SIDED|95.0|0.883|1.283||1-sided|Log Rank|Based on unstratified log-rank test. P-value is nominal p-value without multiplicity adjustment.|Hazard ratio is for Napabucasin + FOLFIRI ± bev vs FOLFIRI ± bev. Based on unstratified Cox Proportional hazards model. A hazard ratio \<1 indicates a lower risk with Napabucasin + FOLFIRI ± bev compared with FOLFIRI ± bev.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||1.283|0.883|0.7434
71772392|NCT03239665|143044901|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||1||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content immediately post-intervention via Fisher's Exact test||||1.0
71772393|NCT03239665|143044901|EQUIVALENCE|Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.||||||0.4908||||||Fisher's Exact test was used (2 x 2) with a significance threshold of 0.05.|Fisher Exact|||Testing between-group differences in dichotomous satisfaction with the program's content at the one-month follow-up via Fisher's Exact test||||0.4908
71772394|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7728|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at baseline via Chi-squared test||||0.7728
71772395|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6871|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6871
71772396|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8259|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.8259
71659088|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.163|TWO_SIDED|95.0|-0.73|0.12|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.12|-0.73|0.163
71732081|NCT02753127|142979176|SUPERIORITY||rate difference|0.1||||0.4797|TWO_SIDED|95.0|-4.9|5.2||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment .|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||5.2|-4.9|0.4797
71772397|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8868|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at baseline via Chi-squared test||||0.8868
71772398|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8069|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.8069
71772399|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8489|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8489
71772400|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3985|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at baseline via Chi-squared test||||0.3985
71732082|NCT02753127|142979176|SUPERIORITY||rate difference|-3.1||||0.783|TWO_SIDED|95.0|-11.0|4.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||4.7|-11.0|0.783
71732083|NCT02753127|142979177|SUPERIORITY||rate difference|-0.9||||0.6776|TWO_SIDED|95.0|-4.8|3.0||1-sided|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by actual stratification factors. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on Harmonic Means method adjusting stratification factor|General population||3.0|-4.8|0.6776
71732084|NCT02753127|142979177|SUPERIORITY||rate difference|-2.0||||0.7513|TWO_SIDED|95.0|-7.7|3.7||1-sided|Z test|Based on one-sided Z test. P-value is nominal p-value without multiplicity adjustment.|Treatment difference and 95% CI is based on normal approximation method.|activated signal transducers and activators of transcription 3 (pSTAT3)-positive (pSTAT3(+)) Subpopulation patients||3.7|-7.7|0.7513
71732085|NCT03826342|142979181|SUPERIORITY|||||||0.2964|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.2964
71772401|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1722|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.1722
71659089|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.91|||<|0.001|TWO_SIDED|95.0|3.18|4.65|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.65|3.18|<0.001
71772402|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7318|||||||Chi-squared|||Testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7318
71772403|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6309|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine post-intervention via Chi-squared test||||0.6309
71732086|NCT03826342|142979181|SUPERIORITY|||||||0.3404|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.3404
71732087|NCT03826342|142979182|SUPERIORITY|||||||0.7915|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.7915
71732088|NCT03826342|142979182|SUPERIORITY|||||||0.2131|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.2131
71732089|NCT03826342|142979183|SUPERIORITY|||||||0.8357|||||||Generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||Baseline to 2-month assessment||||0.8357
71732090|NCT03826342|142979183|SUPERIORITY|||||||0.095|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||2-month assessment to 6-month assessment||||0.0950
71732091|NCT03826342|142979184|SUPERIORITY|||||||0.7496|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.7496
71732092|NCT03826342|142979185|SUPERIORITY|||||||0.4492|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.4492
71732093|NCT03826342|142979186|SUPERIORITY|||||||0.0765|||||||t-test, 2 sided|||||||0.0765
71772404|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7881|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive zoster vaccine at one-month follow-up via Chi-squared test||||0.7881
71772405|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6798|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine post-intervention via Chi-squared test||||0.6798
71772406|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8548|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive influenza vaccine at one-month follow-up via Chi-squared test||||0.8548
71772407|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3182|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine post-intervention via Chi-squared test||||0.3182
71732094|NCT03826342|142979187|SUPERIORITY|||||||0.535|||||||t-test, 2 sided|||||||0.535
71732095|NCT03826342|142979188|SUPERIORITY|||||||0.4302|||||||t-test, 2 sided|||||||0.4302
71732096|NCT03826342|142979189|SUPERIORITY|||||||0.807|||||||generalized linear mixed model analysis|generalized linear mixed model analysis under a negative binomial framework||||||0.8070
71772408|NCT03239665|143044902|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.7986|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants planning to receive pneumonia vaccine at one-month follow-up via Chi-squared test||||0.7986
71772409|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0163|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at baseline via Chi-squared test||||0.0163
71732097|NCT01114360|142979255|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||ANOVA|Two-way repeated measures mixed model ANOVA.||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.075
71732098|NCT01114360|142979255|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||||||0.75
71732099|NCT01114360|142979256|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||ANOVA|||||||0.79
71732100|NCT01114360|142979257|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
71732101|NCT01114360|142979258|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||ANOVA|||||||0.64
71732102|NCT01114360|142979259|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
71732103|NCT01114360|142979260|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||||||0.97
71732104|NCT01114360|142979261|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71732105|NCT01114360|142979262|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||ANOVA|||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.||||0.75
71732106|NCT01114360|142979263|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Friedman|||||||0.71
71732107|NCT01114360|142979264|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Friedman|||||||0.38
71732108|NCT01114360|142979265|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Friedman|||||||0.11
71732109|NCT01114360|142979266|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANOVA|||||||0.96
71732110|NCT01114360|142979267|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71732111|NCT01114360|142979268|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||ANOVA|||||||0.52
71732112|NCT03007745|142979271|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|3.08|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71732113|NCT03007745|142979271|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_DEVIATION|3.97|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71732114|NCT03007745|142979271|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.61||0.9171|TWO_SIDED|||||Adjusted mean changes and adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values|ANCOVA|||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9171
71732115|NCT03007745|142979271|NON_INFERIORITY|We hypothesized that the lower bound of the non-inferiority analysis of FOSQ-10 would be greater than the a-priori threshold of -1.0.|||||>|0.05||||||"Adjusted group difference in mean change in FOSQ-10 score from baseline to Month 3, controlling for baseline FOSQ and site, was -0.06 ± 061 (SEM) (P = 0.917).~The lower bound of the 95% noninferiority confidence interval was -1.08"|ANCOVA|||||||>0.05
71732116|NCT03007745|142979272|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_DEVIATION|4.86|<|0.0001|ONE_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71732117|NCT03007745|142979272|SUPERIORITY||Mean Difference (Net)|-3.51|STANDARD_DEVIATION|5.52|<|0.0001|TWO_SIDED|||||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71772410|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0028|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine post-intervention via Chi-squared test||||0.0028
71732118|NCT03007745|142979272|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.9251|ONE_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. ANCOVA model included main effects for type of study (home versus in-laboratory), site, and the pre-treatment baseline value of the outcome measure.||||0.9251
71732119|NCT03007745|142979273|SUPERIORITY|Paired t-test comparing change in score (3-month - baseline) within group|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||0.4116|ONE_SIDED||||||t-test, 2 sided|Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||Within arm change from baseline to 3 month follow-up||||0.4116
71732120|NCT03007745|142979273|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||0.2201|ONE_SIDED||||||t-test, 2 sided|||Paired t-test comparing change in score (3-month - baseline) within group||||0.2201
71772411|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0433|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.0433
71772412|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0592|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at baseline via Chi-squared test||||0.0592
71772413|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.1843|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine post-intervention via Chi-squared test||||0.1843
71772414|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.5933|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.5933
71772415|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3942|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at baseline via Chi-squared test||||0.3942
71772416|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9062|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine post-intervention via Chi-squared test||||0.9062
71772417|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9618|||||||Chi-squared|||Testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.9618
71772418|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.114|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of zoster vaccine at one-month follow-up via Chi-squared test||||0.1140
71772419|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0141|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of influenza vaccine at one-month follow-up via Chi-squared test||||0.0141
71772420|NCT03239665|143044903|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0457|||||||Chi-squared|||Among those without positive vaccination history at post-test, testing between-group differences in number of participants reporting positive history of pneumonia vaccine at one-month follow-up via Chi-squared test||||0.0457
71772421|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6153|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at baseline via Chi-squared test||||0.6153
71772422|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.8299|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor post-intervention via Chi-squared test||||0.8299
71889090|NCT01279057|143299165|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|117.712|||||TWO_SIDED|90.0|95.41|146.583||||||||146.583|95.410|
71889091|NCT01279057|143299166|SUPERIORITY|||||||0.0018|||||||ANCOVA|||||||0.0018
71889092|NCT01279057|143299166|SUPERIORITY|||||||0.0451|||||||ANCOVA|||||||0.0451
71889093|NCT00110994|143299182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.068|TWO_SIDED|95.0|0.428|1.034|||log rank test|||||1.034|0.428|0.068
71889094|NCT00110994|143299183|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.973|TWO_SIDED|95.0|0.627|1.57|||log rank test|||||1.570|0.627|0.973
71889095|NCT00110994|143299185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.619||||0.039|TWO_SIDED|95.0|0.391|0.98|||log rank test|||||0.980|0.391|0.039
71732121|NCT03007745|142979273|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1732|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes between groups from baseline to month 3 in participants initiated on CPAP (LOCF applied using 1-month data).||||0.1732
71732122|NCT03007745|142979274|SUPERIORITY||Mean Difference (Final Values)|-2.76|STANDARD_DEVIATION|4.73|<|0.0003|ONE_SIDED||||||t-test, 2 sided|Unadjusted||Paired t-test comparing baseline and 3-month measures within group||||<0.0003
71732123|NCT03007745|142979274|SUPERIORITY||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|5.2|<|0.0001|TWO_SIDED||||||t-test, 2 sided|Unadjusted||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) Paired t-test comparing baseline and 3-month measures within group||||<0.0001
71732124|NCT03007745|142979274|SUPERIORITY||Median Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.9||0.673|TWO_SIDED||||||ANCOVA|ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure||Adjusted differences in mean changes were estimated as site-total-sample-size weighted values controlling for treatment group differences in mean pre-treatment baseline values. Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.6730
71732125|NCT03007745|142979275|SUPERIORITY||Mean Difference (Net)|-5.94|STANDARD_DEVIATION|6.17|<|0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)||||<0.0001
71732126|NCT03007745|142979275|SUPERIORITY|Paired t-test comparing baseline and 3-month measures within group (LOCF applied using 1-month data)|Mean Difference (Final Values)|-5.6|STANDARD_DEVIATION|6.96||0.0001|TWO_SIDED|||||Unadjusted|t-test, 2 sided|||Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)||||0.0001
71732127|NCT03007745|142979275|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|1.11||0.9903|TWO_SIDED|||||ANCOVA included main effects for group, site, and the pre-treatment baseline value of the outcome measure|ANCOVA|Adjusted differences in mean changes estimated as site-total-sample-size weighted values controlling for group differences in mean baseline values||Between group comparison of change in Insomnia Severity Index (ISI) at 3 months (LOCF applied using 1-month data)||||0.9903
71732128|NCT03007745|142979279|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Between group comparison of Client Satisfaction Questionnaire (CSQ-8) at 3 months (LOCF applied using 1-month data)||||>0.05
71772423|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0405|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their doctor at one-month follow-up via Chi-squared test||||0.0405
71772424|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.3776|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at baseline via Chi-squared test||||0.3776
71772425|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.2856|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist post-intervention via Chi-squared test||||0.2856
71772426|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0016|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0016
71772427|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.9449|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at baseline via Chi-squared test||||0.9449
71772428|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.6143|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends post-intervention via Chi-squared test||||0.6143
71772429|NCT03239665|143044904|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0036|||||||Chi-squared|||Testing between-group differences in number of participants planning to discuss vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0036
71889096|NCT00110994|143299186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.427||||0.194|TWO_SIDED|95.0|0.114|1.601|||log rank test|||||1.601|0.114|0.194
71889097|NCT00110994|143299188|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||t-test, 2 sided|||||||0.908
71889098|NCT00110994|143299189|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||t-test, 2 sided|||||||0.890
71889099|NCT00110994|143299190|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||t-test, 2 sided|||||||0.201
71889100|NCT00110994|143299191|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||t-test, 2 sided|||||||0.168
71889101|NCT00531960|143299201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.806|TWO_SIDED|95.0|0.7|1.59|||Log Rank|||||1.59|0.70|0.8060
71889102|NCT00531960|143299203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.4063|TWO_SIDED|95.0|0.75|2.05|||Log Rank|||||2.05|0.75|0.4063
71889103|NCT00531960|143299204|SUPERIORITY_OR_OTHER||Difference in Response Rates|-17.28||||0.0444|TWO_SIDED|95.0|-34.8|0.3|||Chi-squared||The 95% CI for the difference of 2 rates was determined by using the Hauck-Anderson method.|||0.3|-34.8|0.0444
71889104|NCT00531960|143299205|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|-12.2||||0.0944|TWO_SIDED|95.0|-27.3|2.8|||Chi-squared||The 95% CI for the difference in disease control was determined using the Hauck-Anderson method.|||2.8|-27.3|0.0944
71732129|NCT03007745|142979280|NON_INFERIORITY|The a-priori lower bound selected for the non-inferiority analysis of average daily CPAP use over 3 months was -0.75 hours.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.37||0.308|TWO_SIDED|||||Group difference (REVAMP - In-person) in mean CPAP daily use over all days adjusted for investigative site.|ANCOVA|The lower bound of the 95% noninferiority confidence interval was -0.22.||||||0.308
71889105|NCT03183128|143299316|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.001|TWO_SIDED|95.0|0.18|0.58||P-value presented for both hypothesis tests: H0: RR≥1 and H0: RR≥0.833.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|||0.58|0.18|<0.001
71732130|NCT00385723|142979285|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED|95.0|-0.19|-0.028||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months||-0.028|-0.19|0.03
71732131|NCT00385723|142979285|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.004|TWO_SIDED|95.0|-0.22|-0.052||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.052|-0.22|0.004
71732132|NCT00385723|142979286|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.41|STANDARD_ERROR_OF_MEAN|0.1||0.0003|TWO_SIDED|95.0|-0.62|-0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months.||-0.21|-0.62|0.0003
71732133|NCT00385723|142979286|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.43|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.64|-0.22||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||-0.22|-0.64|0.0002
71732134|NCT00385723|142979287|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.8|TWO_SIDED|95.0|-0.64|0.18||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.18|-0.64|0.80
71732135|NCT00385723|142979287|SUPERIORITY_OR_OTHER||Difference in change from baseline|-0.2|STANDARD_ERROR_OF_MEAN|0.21||1|TWO_SIDED|95.0|-0.61|0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.||0.21|-0.61|1.0
71732136|NCT01533922|142979309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.191|0.298|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 once daily (QD) minus Placebo|||0.298|0.191|<0.0001
71732137|NCT01533922|142979309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.065|0.172|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg|||0.172|0.065|<0.0001
71732138|NCT01533922|142979309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.061|0.167|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.167|0.061|<0.0001
71889106|NCT03183128|143299317|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.19|0.67||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 4||0.67|0.19|<0.001
71732139|NCT01533922|142979309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.164|0.271|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.271|0.164|<0.0001
71732140|NCT01533922|142979309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.027||0.0008|TWO_SIDED|95.0|0.038|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.038|0.0008
71772430|NCT03239665|143044905|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.|||||<|0.0001|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their doctor at one-month follow-up via Chi-squared test||||<0.0001
71732141|NCT01533922|142979309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0015|TWO_SIDED|95.0|0.034|0.141|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.141|0.034|0.0015
71732142|NCT01533922|142979310|SUPERIORITY_OR_OTHER||Ratio|1.209|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|1.132|1.292|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.292|1.132|<0.0001
71732143|NCT01533922|142979310|SUPERIORITY_OR_OTHER||Ratio|1.002|STANDARD_ERROR_OF_MEAN|0.034||0.9633|TWO_SIDED|95.0|0.937|1.07|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Olodaterol 5 mcg QD|||1.070|0.937|0.9633
71732144|NCT01533922|142979310|SUPERIORITY_OR_OTHER||Ratio|0.993|STANDARD_ERROR_OF_MEAN|0.033||0.8415|TWO_SIDED|95.0|0.93|1.061|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.061|0.930|0.8415
71732145|NCT01533922|142979310|SUPERIORITY_OR_OTHER||Ratio|1.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|1.184|1.351|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.351|1.184|<0.0001
71772431|NCT03239665|143044905|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0012|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their pharmacist at one-month follow-up via Chi-squared test||||0.0012
71659090|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.001|TWO_SIDED|95.0|0.35|1.38|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.35|0.001
71772432|NCT03239665|143044905|EQUIVALENCE|Chi-squared test was used with a significance threshold of 0.05.||||||0.0034|||||||Chi-squared|||Testing between-group differences in number of participants having discussed vaccines with their family/friends at one-month follow-up via Chi-squared test||||0.0034
71659091|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.003|TWO_SIDED|95.0|0.26|1.31|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.31|0.26|0.003
71659092|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.32|3.79|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.79|2.32|<0.001
71659093|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|||<|0.001|TWO_SIDED|95.0|2.39|3.87|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.87|2.39|<0.001
71732146|NCT01533922|142979310|SUPERIORITY_OR_OTHER||Ratio|1.047|STANDARD_ERROR_OF_MEAN|0.035||0.1717|TWO_SIDED|95.0|0.98|1.119|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.119|0.980|0.1717
71732147|NCT01533922|142979310|SUPERIORITY_OR_OTHER||Ratio|1.039|STANDARD_ERROR_OF_MEAN|0.035||0.261|TWO_SIDED|95.0|0.972|1.11|||Mixed Models Analysis||Ratio calculated asTiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.110|0.972|0.2610
71732148|NCT01533922|142979311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0004|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.001|-0.004|0.0004
71732149|NCT01533922|142979311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.8291|TWO_SIDED|95.0|-0.001|0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.002|-0.001|0.8291
71732150|NCT01533922|142979311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.857|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.8570
71732151|NCT01533922|142979311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
71772433|NCT01582854|143044920|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.005|TWO_SIDED|95.0|-3.9|-0.7|||ANCOVA|||||-0.7|-3.9|0.005
71772434|NCT01582854|143044921|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74||0.122|TWO_SIDED|95.0|-2.6|0.3|||ANCOVA|||Month 3||0.3|-2.6|0.122
71772435|NCT01582854|143044921|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.5|-1.9|||ANCOVA|||Month 12||-1.9|-5.5|<0.001
71772436|NCT01582854|143044922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.111|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||End of Infusion Period||0.7|-0.1|0.111
71772437|NCT01582854|143044922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.27||0.016|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Month 3||1.2|0.1|0.016
71659094|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.769|TWO_SIDED|95.0|-0.6|0.44|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.44|-0.60|0.769
71732152|NCT01533922|142979311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.7294|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.001|-0.002|0.7294
71732153|NCT01533922|142979311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.4567|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.4567
71732154|NCT01533922|142979312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.293|0.352|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.352|0.293|<0.0001
71732155|NCT01533922|142979312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.101|0.16|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.160|0.101|<0.0001
71772438|NCT01582854|143044922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.013|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Month 6||1.3|0.2|0.013
71772439|NCT01582854|143044922|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|0.3|1.7|||ANCOVA|||Month 12||1.7|0.3|0.003
71772440|NCT01582854|143044923|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.032|TWO_SIDED|95.0|0.9|19.5|||Chi-squared|||Month 3||19.5|0.9|0.032
71772441|NCT01582854|143044923|SUPERIORITY_OR_OTHER||Percent Difference|10.2||||0.034|TWO_SIDED|95.0|0.8|19.5|||Chi-squared|||Month 6||19.5|0.8|0.034
71772442|NCT01582854|143044923|SUPERIORITY_OR_OTHER||Percent Difference|10.1||||0.035|TWO_SIDED|95.0|0.8|19.3|||Chi-squared|||Month 12||19.3|0.8|0.035
71772443|NCT01582854|143044924|SUPERIORITY_OR_OTHER||Percent Difference|-3.2||||0.251|TWO_SIDED|95.0|-8.5|2.1|||Fisher Exact|||Month 6||2.1|-8.5|0.251
71772444|NCT01582854|143044924|SUPERIORITY_OR_OTHER||Percent Difference|-4.0||||0.221|TWO_SIDED|95.0|-9.7|1.7|||Fisher Exact|||Month 12||1.7|-9.7|0.221
71772445|NCT01582854|143044925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||End of Infusion Period||0.1|-0.4|0.239
71659095|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|4.65|||<|0.001|TWO_SIDED|95.0|3.88|5.42|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.42|3.88|<0.001
71659096|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.002|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.40|0.32|0.002
71659097|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|0.83|1.93|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.93|0.83|<0.001
71732156|NCT01533922|142979312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.084|0.143|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.143|0.084|<0.0001
71732157|NCT01533922|142979312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.256|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.315|0.256|<0.0001
71732158|NCT01533922|142979312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.063|0.123|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.123|0.063|<0.0001
71732159|NCT01533922|142979312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.047|0.106|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.106|0.047|<0.0001
71732160|NCT02553538|142979317|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71732161|NCT02553538|142979318|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
71732162|NCT02553538|142979319|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Logistic|||||||<0.001
71732163|NCT02553538|142979320|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71772446|NCT01582854|143044925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.136|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Month 3||0.1|-0.5|0.136
71659098|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.79|||<|0.001|TWO_SIDED|95.0|3.02|4.56|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.56|3.02|<0.001
71659099|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.001|TWO_SIDED|95.0|2.49|4.04|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.04|2.49|<0.001
71732164|NCT03344640|142979347|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.875|TWO_SIDED|90.0|-8.84|7.3|||LS mean|LS mean change from baseline in WORC total percentage score||All Patients at day 99||7.30|-8.84|0.875
71772447|NCT01582854|143044925|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.89|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||Month 6||0.2|-0.3|0.890
71772448|NCT01582854|143044925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.455|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Month 12||0.2|-0.4|0.455
71772449|NCT06138145|143044932|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71732165|NCT03344640|142979348|SUPERIORITY||Difference and 90% CI versus placebo|3.97||||0.19|TWO_SIDED|90.0|-1.03|8.97|||LS mean|LS mean change from baseline in WORC total percentage score||All patientts at day 15||8.97|-1.03|0.190
71732166|NCT03344640|142979348|SUPERIORITY||Difference and 90% CI versus placebo|3.97|||||TWO_SIDED|90.0|-3.39|9.11|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 29||9.11|-3.39|
71732167|NCT03344640|142979348|SUPERIORITY||Difference and 90% CI versus placebo|0.761||||0.761|TWO_SIDED|90.0|-8.81|6.08|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 57||6.08|-8.81|0.761
71732168|NCT03344640|142979348|SUPERIORITY||Difference and 90% CI versus placebo|0.765||||0.765|TWO_SIDED|90.0|-6.27|9.03|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 85||9.03|-6.27|0.765
71732169|NCT03344640|142979348|SUPERIORITY||Difference and 90% CI versus placebo|0.491||||0.491|TWO_SIDED|90.0|-4.73|11.45|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at day 127||11.45|-4.73|0.491
71732170|NCT03344640|142979348|SUPERIORITY||Difference and 90% CI versus placebo|2.44||||0.639|TWO_SIDED|90.0|-6.19|11.07|||LS Mean|LS mean change from baseline in WORC total percentage score||All patients at end of study||11.07|-6.19|0.639
71732171|NCT03344640|142979349|SUPERIORITY||Difference and 90% CI versus Placebo|1.23||||0.735|TWO_SIDED|90.0|-4.81|7.28||Difference and 90% CI versus placebo|LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD Analysis Set) at day 99||7.28|-4.81|0.735
71772450|NCT06138145|143044932|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mann-Whitney U test|||||||<0.05
71772451|NCT06138145|143044932|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71772452|NCT02652767|143044933|SUPERIORITY||Mean Difference (Net)|-0.012||||0.889|TWO_SIDED|95.0|-0.182|0.158|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.158|-0.182|0.8890
71772453|NCT00322153|143044947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.001|TWO_SIDED|95.0|1.0|4.2|||ANCOVA|Least-squares mean (-0.4 in placebo and 2.2 in memantine ER) are controlled for center and adjusted for SIB baseline value.||The co-primary efficacy parameter was change from Baseline to Week 24 in SIB total score. Missing SIB total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||4.2|1.0|0.001
71889107|NCT03183128|143299317|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|95.0|0.24|0.65||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 12||0.65|0.24|<0.001
71732172|NCT03344640|142979349|SUPERIORITY||Difference and 90% CI versus Placebo|1.51||||0.689|TWO_SIDED|90.0|-4.76|7.79|||LS Mean|LS mean change from baseline in QuickDASH total score||Statistical analysis results of QuickDASH total score (PD analysis set) at End of Study||7.79|-4.76|0.689
71889108|NCT03183128|143299317|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.3|0.73||P-value presented is for the hypothesis test: H0: RR ≥1.0.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel estimate is stratified by age (\<65 years, ≥65 years) and prior antibiotic regimen (vancomycin, fidaxomicin).|RR defined as the recurrence rates of SER-109 divided by Placebo. Cochran-Mantel-Haenszel estimate of RR, stratified by age group (\<65 years, ≥65 years) and prior antibiotic regimen for the qualifying episode (vancomycin, fidaxomicin), is reported.|CDI recurrence rates at Week 24||0.73|0.30|<0.001
71659100|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.062|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.06|-0.03|0.062
71732173|NCT03344640|142979350|SUPERIORITY||Difference and 90% CI vesus placebo|3.5||||0.411|TWO_SIDED|90.0|-3.54|10.54|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at day 99||10.54|-3.54|0.411
71732174|NCT03344640|142979350|SUPERIORITY||Difference and 90% CI versus placebo|1.14||||0.804|TWO_SIDED|90.0|-6.5|8.78|||LS Mean|LS mean change from baseline in ASES total percentage score||Statistical analysis results of ASES total score (PD analysis) at End of Study set)||8.78|-6.50|0.804
71732175|NCT03344640|142979351|SUPERIORITY||Difference and 90% CI versus placebo|-1.26||||0.706|TWO_SIDED|90.0|-6.81|4.29|||LS Mean|LS Mean change from baseline in Your Health Today Score at day 99||Statistical analysis results of Your Health Today EQ-5D-5L Index score at day 99 (PD Analysis Set)||4.29|-6.81|0.706
71732176|NCT03344640|142979351|SUPERIORITY||Difference and 90% CI versus placebo|-1.9||||0.647|TWO_SIDED|90.0|-8.79|4.99|||LS Mean|LS mean change from baseline in Your Health Today score||Statistical analysis results of Your Health Today EQ-5D-5L Index score at End of Study||4.99|-8.79|0.647
71732177|NCT03344640|142979352|SUPERIORITY||Difference and 90% CI versus placebo|0.01||||0.613|TWO_SIDED|90.0|-0.03|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at day 99 (PD Analysis Set)||0.06|-0.03|0.613
71732178|NCT03344640|142979352|SUPERIORITY||Difference and 90% CI versus placebo|0.02||||0.74|TWO_SIDED|90.0|-0.04|0.06|||LS Mean|LS mean change from baseline in EQ-5D-5L Index score||Statistical analysis results of of EQ-5D-5L Index score at End of Study (PD Analysis Set)||0.06|-0.04|0.740
71732179|NCT03344640|142979353|SUPERIORITY||Difference and 90% CI versus placebo|-5.55||||0.281|TWO_SIDED|90.0|-14.07|2.97|||LS Mean|LS MMean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||2.97|-14.07|0.281
71732180|NCT03344640|142979353|SUPERIORITY||Difference and 90% CI versus placebo|-1.49||||0.78|TWO_SIDED|90.0|-10.33|7.35|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at End of Study||7.35|-10.33|0.780
71732181|NCT03344640|142979354|SUPERIORITY||Difference and 90% CI versus placebo|-3.32||||0.489|TWO_SIDED|90.0|-11.28|4.64|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale (PD Analysis Set) at day 99||4.64|-11.28|0.489
71732182|NCT03344640|142979354|SUPERIORITY||Difference and 90% CI versus placebo|-8.29||||0.087|TWO_SIDED|90.0|-16.26|-0.32|||LS Mean|LS Mean change from baseline in VAS score||Statistical analysis results of pain score using VAS scale at End of Study||-0.32|-16.26|0.087
71732183|NCT03344640|142979355|SUPERIORITY||Difference and 99% CL versus placebo|6.1||||0.21|TWO_SIDED|90.0|-1.9|13.91|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at day 99||13.91|-1.90|0.210
71732184|NCT03344640|142979355|SUPERIORITY||Difference and 90% CI versus placebo|-0.37||||0.942|TWO_SIDED|90.0|-8.86|8.11|||LS Mean|LS Mean CFB (90% CI)||Statistical analysis results of PhGA score using VAS scale at End of Study||8.11|-8.86|0.942
71732185|NCT00357656|142979359|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority by the 200% margin of non-inferiority was demonstrated if the upper confidence limit of a 95% 2-sided confidence interval for the ratio of means did not exceed 200%.|Mean ratio CI/BI|0.924||||0.001|TWO_SIDED|95.0|0.816|1.046||one-sided p-value against the null hypothesis of ration \>=200%|Hypothesis test|||The main analysis used a point estimate and a two-sided 95% confidence interval for ratio of the primary outcome measure of CI over BI combined over the three strata: stratum A: unilateral knee replacement, stratum B: hip surgery, stratum C: shoulder/elbow/ankle/knee (except knee replacement) surgery.||1.046|0.816|0.001
71739217|NCT02669121|142991145|SUPERIORITY||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|-0.711|0.977|||||||The vaccine efficacy was met if lower bound of CI for vaccine efficacy was above 0. Vaccine efficacy (VE) was defined as 1-(hazard rate for NoV vaccine arm / hazard rate for placebo arm), where the hazard ratio is from the PH model. The 95% CI for the VE was obtained by taking 1 minus the 95% CI of the hazard ratio from the PH model.|0.977|-0.711|
71739218|NCT03216746|142991146|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71739219|NCT02980133|142991178|SUPERIORITY||LS mean difference|1.9||||0.285|TWO_SIDED|95.0|-1.6|5.3||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||5.3|-1.6|0.285
71739220|NCT02980133|142991179|SUPERIORITY||Least square (LS) mean difference|6.0|||<|0.001|TWO_SIDED|95.0|3.2|8.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (inhaled corticosteroid \[ICS\] or noncorticosteroid \[NCS\]), and investigational medicinal product (IMP) treatment group.||8.8|3.2|<0.001
71732186|NCT02573246|142979366|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|-0.323|STANDARD_ERROR_OF_MEAN|0.131||0.019|TWO_SIDED|95.0|-0.59|-0.056||A priori threshold for significance was .05.|Mixed Models Analysis||The results presented are between the active right and sham conditions.|A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||-.056|-.590|0.019
71732187|NCT02573246|142979366|SUPERIORITY||Mean Difference (Net)|0.237|STANDARD_ERROR_OF_MEAN|0.133||0.08|TWO_SIDED|95.0|-0.034|0.508|||Mixed Models Analysis|||A mixed models analysis of variance (MMANOVA) examining regulation duration during each regulation period was conducted using treatment condition (active right, active left, sham), experimental condition (regulation1, regulation2, regulation3), and baseline as predictors.||.508|-.034|.08
71732188|NCT02573246|142979366|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_ERROR_OF_MEAN|0.103||0.033|TWO_SIDED|95.0|-0.434|-0.02||A priori threshold for significance was set to .05.|Mixed Models Analysis|we controlled for baseline and for the distance between the brain and the scalp||Regulation duration was transformed using a logarithmic transformation to achieve normality||-.020|-.434|.033
71732189|NCT02573246|142979367|SUPERIORITY||Mean Difference (Net)|-0.124|STANDARD_ERROR_OF_MEAN|0.184||0.51|TWO_SIDED|95.0|-0.504|0.256||A priori set threshold for statistical significance was 0.05|ANOVA|||A univariate general linear model was employed to test of regulation duration, transformed for normality.||.256|-0.504|.51
71732190|NCT02573246|142979367|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.18||0.97|TWO_SIDED|95.0|-0.364|0.378|||ANOVA|||||.378|-.364|.97
71732191|NCT02573246|142979367|SUPERIORITY||Mean Difference (Net)|0.147993|STANDARD_ERROR_OF_MEAN|0.167031||0.39|TWO_SIDED|95.0|-0.215936|0.511921||A priori set significance threshold was 0.05|t-test, 2 sided|||A t test of the variable 'time it took to return to HR baseline', transformed for normality was used to examine between condition differences at the 1 month follow up.||0.511921|-0.215936|0.39
71732192|NCT02573246|142979368|SUPERIORITY|HF-HRV was transformed using the function lg10\*(HF-HRV\*1000000) in order to be normally distributed.|Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.51||0.022|TWO_SIDED|95.0|0.044|0.267||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||In the original study (CR+active left rTMS vs CR+ active right rTMS vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation.||.267|.044|.022
71732193|NCT02573246|142979368|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.052||0.0499|TWO_SIDED|95.0|0.000037|0.213074|||Mixed Models Analysis|||MMANOVA||0.213074|0.000037|0.0499
71732194|NCT02573246|142979368|SUPERIORITY|Aimed to recruit 20 participants in each condition to align with other neurostimulation studies where 6-20 adults per condition were sufficient to demonstrate proof-of-concept for novel treatments (Bentwich et al., 2011; Cunningham et al., 2015).|Mean Difference (Net)|0.172|STANDARD_DEVIATION|0.38|<|1e-06|TWO_SIDED|95.0|0.129|0.215||Significance threshold was set at p = 0.05.|Mixed Models Analysis||The MMANOVA analysis used an unstructured covariance structure.|In the supplemental study (CR+active left rTMS with functional targeting vs CR+sham rTMS), mixed-effects hierarchical linear models (MMANOVA) with analytically determined covariance structures were used to analyze the repeated measures data. We hypothesized that active neurostimulation would increase HF-HRV during regulation when compared with sham.||.215|.129|<.000001
71732195|NCT02573246|142979369|SUPERIORITY||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.091544||0.236|TWO_SIDED|95.0|-0.078086|0.300661||A priori threshold was set to 0.05.|ANCOVA|Brain to skull difference and intake difference in dlPFC activation between regulation and feeling negative were included as confounds.|Parameter estimate is the value of the difference between active stimulation and sham stimulation.|Difference between treatment conditions in dlPFC activation change between feeling negative emotions and downregulation of negative affect a week after intervention, when controlling for baseline activation difference||0.300661|-0.078086|.236
71732196|NCT02573246|142979369|SUPERIORITY||Mean Difference (Net)|0.359024|STANDARD_ERROR_OF_MEAN|0.144067||0.020347|TWO_SIDED|95.0|0.061|0.657049||Threshold was set at 0.05 a priori|ANCOVA|Brain to skull difference and intake difference in vlpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vlPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted using FSL featquery. A univariate general linear model excluding one outlier from the active condition was conducted for this outcome measure.||0.657049|0.061000|0.020347
71732197|NCT02573246|142979369|SUPERIORITY||Mean Difference (Net)|0.221683|STANDARD_ERROR_OF_MEAN|0.461481||0.635|TWO_SIDED|95.0|-0.732963|1.17633||A priori threshold was set to .05|ANCOVA|Brain to skull difference and intake difference in vmpfc activation between regulation and feeling negative were included as confounds.||Expected significantly higher activation following active intervention in the vmPFC when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with FSL featquery.||1.176330|-0.732963|0.635
71732198|NCT02573246|142979369|SUPERIORITY||Mean Difference (Net)|0.179412|STANDARD_ERROR_OF_MEAN|0.178029||0.324|TWO_SIDED|95.0|-0.188868|0.547692||a priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in amygdala activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the amygdala when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. ROI data was extracted with featquery (FSL).||0.547692|-0.188868|.324
71732199|NCT02573246|142979369|SUPERIORITY||Mean Difference (Net)|0.021231|STANDARD_ERROR_OF_MEAN|0.071185||0.76819|TWO_SIDED|95.0|-0.126027|0.168489||A priori set threshold was 0.05|ANCOVA|Brain to skull difference and intake difference in insula activation between regulation and feeling negative were included as confounds.||Expected significantly lower activation following active intervention in the insula when compared to sham when engaging in downregulation versus passive experience of negative emotions induced with autobiographical stressors. FSL featquery tool was used to extract ROI (region of interest) data.||0.168489|-0.126027|0.768190
71889109|NCT00330187|143299327|SUPERIORITY||Odds Ratio (OR)|3.6||||0.07|TWO_SIDED|95.0|0.9|14.4|||Regression, Logistic|||||14.4|0.9|0.07
71732200|NCT02573246|142979370|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.455||0.69|TWO_SIDED|95.0|-0.553|1.293||a priori threshold for significance was 0.05|ANOVA|||Likert-type questions about acceptability were rated on a scale from 0 (not at all) to 9 (extremely) and then averaged to create a mean for acceptability. This average score was normally distributed and therefore was entered into a univariate general linear model where acceptability was entered as a dependent variable and condition as a fixed factor.||1.293|-0.553|0.69
71889110|NCT00754156|143299372|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71889111|NCT01751971|143299387|SUPERIORITY||Mean Difference (Net)|10.5||||0.4|TWO_SIDED|95.0|-16.0|37.1|||t-test, 2 sided||Positive estimated value would represent a greater reduction in AHI with oxygen (% sham) in the high vs low loop gain group.|"Primary statistical comparison was the percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %----between two phenotypic patient subgroups. Patient subgroups were defined by the loop gain (LG1) measured on the sham night as high or low (a priori cutoff LG1=0.7)."||37.1|-16|0.4
71889112|NCT01751971|143299387|SUPERIORITY||Mean Difference (Final Values)|17.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|10.7|24.1|||t-test, 2 sided||Direction of comparison: Positive estimation parameter would indicate lower AHI on oxygen versus sham.|Here we aimed to confirm that there was a difference between AHI on oxygen vs sham (overall, i.e. in unselected patients). This test, however was not part of our primary objective.||24.1|10.7|<0.001
71889113|NCT01751971|143299387|SUPERIORITY||Mean Difference (Net)|42.8||||0.001|TWO_SIDED|95.0|21.0|64.6|||t-test, 2 sided||Direction of comparison: Positive estimated value would indicate a greater percentage reduction in AHI (oxygen vs. sham) in favorable vs. unfavorable subgroups.|"The primary goal of the study was to identify a phenotypic subgroup of patients with sleep apnea that responds preferentially to oxygen (percent reduction in AHI----\[AHI(sham)-AHI(oxygen)\]/AHI(sham) %). We defined patient subgroups (favorable versus unfavorable) based on the four key phenotypic traits (loop gain, collapsibility, arousal threshold, muscle responses) measured on the sham night, with the use of multiple logistic regression and leave-one-out cross validation."||64.6|21.0|0.001
71889114|NCT00364182|143299393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|||<|0.0001|TWO_SIDED|95.0|-36.5|-24.5||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-24.5|-36.5|<0.0001
71889115|NCT00364182|143299393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5|||<|0.0001|TWO_SIDED|95.0|-38.5|-26.6||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||-26.6|-38.5|<0.0001
71732201|NCT02573246|142979370|SUPERIORITY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.43||0.53|TWO_SIDED|95.0|-0.592|1.139|||ANOVA|||||1.139|-.592|.53
71732202|NCT02573246|142979370|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.45||0.15|TWO_SIDED|95.0|-1.59|0.27||a priory threshold for significance was .05|t-test, 2 sided|||we compared differences in acceptability between conditions using an independent samples t-test (acceptability was normally distributed)||0.27|-1.59|0.15
71732203|NCT02573246|142979371|SUPERIORITY||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.304||0.551|TWO_SIDED|95.0|-0.322|0.912||a priori threshold was set to 0.05|ANOVA|||We compared differences between conditions in the perceived feasibility of the procedures. Feasibility average was normally distributed and therefore a general linear model, univariate was employed to test between condition effects.||0.912|-0.322|0.551
71732204|NCT02573246|142979371|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.281||0.995|TWO_SIDED|95.0|-0.567|0.571|||ANOVA|||||.571|-.567|.995
71732205|NCT02573246|142979371|SUPERIORITY||Mean Difference (Net)|-0.09957|STANDARD_ERROR_OF_MEAN|0.371||0.791|TWO_SIDED|95.0|-0.8672|0.6681||A priori threshold for statistical significance was set to 0.05|t-test, 2 sided|df = 23||We examined differences in feasibility between the active and sham condition in the sub-study where fMRI targeting was utilized. Average feasibility was normally distributed and therefore an independent samples t-test was used to test this outcome.||0.6681|-0.8672|0.791
71732206|NCT02573246|142979372|SUPERIORITY||Mean Difference (Net)|6.04|STANDARD_ERROR_OF_MEAN|8.048||0.61|TWO_SIDED|95.0|-9.522964|21.60462||A priori threshold was set to 0.05|Mixed Models Analysis|||To test the long-term effects of the intervention, a MMANOVA model was conducted examining between-condition differences at the 1-week and 1-month follow-up in the OQ-45. Baseline was co-varied.||21.604620|-9.522964|0.61
71732207|NCT02573246|142979372|SUPERIORITY||Mean Difference (Net)|-0.906|STANDARD_ERROR_OF_MEAN|7.37||0.9|TWO_SIDED|95.0|-15.83|14.02||a priori threshold was set to .05|Mixed Models Analysis|||||14.02|-15.83|.90
71732208|NCT02573246|142979372|SUPERIORITY||Mean Difference (Net)|10.46|STANDARD_ERROR_OF_MEAN|7.93||0.2|TWO_SIDED|95.0|-5.971581|26.892619||threshold was set to 0.05 a priori|Mixed Models Analysis||HLM models used a compound symmetry covariance structure.|||26.892619|-5.971581|.20
71732209|NCT02573246|142979373|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.258||0.034|TWO_SIDED|95.0|-1.062356|-0.043203||A priori threshold was set to .05 for significance.|Mixed Models Analysis|Subjective Units of Distress (SUDS) right before the intervention were co-varied as baseline.|Results reported are for active left vs. sham comparison.|Hypothesized that active neurostimulation would lead to lower daily distress than sham stimulation. We used a hierarchical linear model (HLM) for this analysis with an identity covariance structure (random intercept and random slope).||-0.043203|-1.062356|.034
71732210|NCT02573246|142979373|SUPERIORITY||Mean Difference (Net)|0.631|STANDARD_ERROR_OF_MEAN|0.404||0.133|TWO_SIDED|95.0|-0.208|1.47||A priori set threshold was .05|Mixed Models Analysis|||Hypothesized that active neurostimulation will lead to less daily distress than sham neurostimulation during the ambulatory data collection. An HLM analysis was conducted using an unstructured covariance structure and reported distress right before the intervention as baseline.||1.47|-.208|.133
71732211|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|-1.300772|STANDARD_ERROR_OF_MEAN|2.670936||0.629061|TWO_SIDED|95.0|-6.708548|4.107||A priori threshold was set to .05|Mixed Models Analysis|Intake values for the dependent measures were covaried. The time by condition interaction term was included.||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less functional impairment than sham neurostimulation.||4.107|-6.708548|0.629061
71732212|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|-0.977394|STANDARD_ERROR_OF_MEAN|2.605189||0.71|TWO_SIDED|95.0|-6.255223|4.300434|||Mixed Models Analysis|||We expected lower functional impairment in the active right versus the sham condition.||4.300434|-6.255223|0.71
71732213|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|-3.292137|STANDARD_ERROR_OF_MEAN|3.314194||0.331|TWO_SIDED|95.0|-10.157811|3.573537||A priori set threshold was .05|Mixed Models Analysis|Baseline WSAS was covaried|The analysis compared sham versus active stimulation.|Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology in the substudy also. We expected active neurostimulation to lead to less impairment than sham neurostimulation.||3.573537|-10.157811|0.331
71732214|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|0.284589|STANDARD_ERROR_OF_MEAN|0.276698||0.31|TWO_SIDED|95.0|-0.27603|0.845209||A priori set threshold for significance was 0.05|Mixed Models Analysis|baseline was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.845209|-0.276030|0.31
71732215|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|10.129377|STANDARD_ERROR_OF_MEAN|9.150339||0.275257|TWO_SIDED|95.0|-8.394724|28.653479|||Mixed Models Analysis|||We hypothesized that active right neurostimulation would yield lower emotional dysregulation after the intervention when compared to sham neurostimulation.||28.653479|-8.394724|0.275257
71732216|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|-13.187|STANDARD_ERROR_OF_MEAN|6.212753||0.044|TWO_SIDED|95.0|-26.002351|-0.372281||A priori set significance threshold was 0.05|Mixed Models Analysis|||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to less emotional dysregulation than sham neurostimulation.||-0.372281|-26.002351|0.044
71732217|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|0.927909|STANDARD_ERROR_OF_MEAN|9.603423||0.924|TWO_SIDED|95.0|-18.508252|20.364071||A priori set threshold for statistical significance was 0.05|Mixed Models Analysis|baseline was covaried||We expected active stimulation to lead to less emotional dysregulation than sham neurostimulation. A MMANOVA model was employed, controlling for baseline.||20.364071|-18.508252|.924
71732218|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|-0.017547|STANDARD_ERROR_OF_MEAN|0.267983||0.95|TWO_SIDED|95.0|-0.560994|0.525901|||Mixed Models Analysis|||we expected more use of cr following active right neurostimulation then after following sham neurostimulation.||0.525901|-0.560994|.95
71732219|NCT02573246|142979374|SUPERIORITY||Mean Difference (Net)|-0.096719|STANDARD_ERROR_OF_MEAN|0.389897||0.806|TWO_SIDED|95.0|-0.900919|0.707481||A priori set significance threshold was 0.05|Mixed Models Analysis|Baseline use of cognitive restructuring was covaried||Mixed model analyses of variance (MMANOVAs) were conducted to explore the difference between active and sham neurostimulation on self reported indices of regulation and psychopathology. We expected active neurostimulation to lead to more use of cognitive restructuring than sham neurostimulation.||0.707481|-0.900919|.806
71732220|NCT00316888|142979415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218|||||||one sample binomial test|||Null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.218
71732221|NCT00316888|142979415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592|||||||one sample binomial test|||The null hypothesis is that the local failure rate at 3 years is no more than 35%.||||0.592
71732222|NCT00815191|142979428|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority delta of 0.5°C|Mean Difference (Final Values)|0.091|||<|0.0001|TWO_SIDED|95.0|-0.139|0.321|||ANOVA|Repeated measures ANOVA||||0.321|-0.139|<0.0001
71772454|NCT00322153|143044948|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||The co-primary efficacy parameter was CIBIC-Plus total score at week 24. Missing CIBIC-Plus total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||||0.008
71772455|NCT00322153|143044949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.177|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|Least-squares mean (-1.7 in placebo and -1.0 in memantine ER) are controlled for center and adjusted for ADCS-ADL19 baseline value.||The secondary efficacy parameter was change from Baseline at Week 24 in the total score of the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL19). Missing scores at week 24 were imputed using the last-observation-carried-forward (LOCF) approach.||1.8|-0.3|0.177
71831517|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.003||||0.949|TWO_SIDED|95.0|-0.084|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 12|||0.090|-0.084|0.949
71732223|NCT01291836|142979429|SUPERIORITY_OR_OTHER_LEGACY||Area under Receiver-Operator Curve (ROC)|0.658|||||TWO_SIDED|95.0|0.586|0.73||||||Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.73|0.586|
71732224|NCT01291836|142979430|SUPERIORITY_OR_OTHER_LEGACY||ROC AUC|0.65|||||TWO_SIDED|95.0|0.598|0.702||||||Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|0.702|0.598|
71732225|NCT02576860|142979487|SUPERIORITY|||||||0.799|||||||ANCOVA|||||||0.799
71732226|NCT02576860|142979488|SUPERIORITY|||||||0.858|||||||Cochran-Mantel-Haenszel|||||||0.858
71831518|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.259|TWO_SIDED|95.0|-0.044|0.163||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 18|||0.163|-0.044|0.259
71889116|NCT00364182|143299393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.2167|TWO_SIDED|95.0|-1.2|5.2||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA|||||5.2|-1.2|0.2167
71889117|NCT00364182|143299394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.002|TWO_SIDED|95.0|0.1|0.6|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.6|0.1|0.002
71889118|NCT00364182|143299394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.021|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|0.1|0.021
71659101|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|4.83|||<|0.001|TWO_SIDED|95.0|4.01|5.64|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.64|4.01|<0.001
71732227|NCT00121641|142979500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.33|-0.90|<.0001
71659102|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.009|TWO_SIDED|95.0|0.19|1.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.33|0.19|0.009
71889119|NCT00364182|143299394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.004|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.9|0.2|0.004
71659103|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|1.17|2.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.33|1.17|<0.001
71732228|NCT00121641|142979500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.93|-0.36||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.36|-0.93|<.0001
71732229|NCT00121641|142979500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.02|-0.44||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-0.44|-1.02|<.0001
71732230|NCT00121641|142979501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|5.53||0.0002|TWO_SIDED|95.0|-31.47|-9.72||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-9.72|-31.47|0.0002
71732231|NCT00121641|142979501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|STANDARD_ERROR_OF_MEAN|5.48||0.0074|TWO_SIDED|95.0|-25.5|-3.97||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-3.97|-25.50|0.0074
71732232|NCT00121641|142979501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.81|STANDARD_ERROR_OF_MEAN|5.58|<|0.0001|TWO_SIDED|95.0|-33.79|-11.84||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-11.84|-33.79|<.0001
71732233|NCT00121641|142979502|SUPERIORITY_OR_OTHER||Difference in Proportions|11.1||||0.1141|TWO_SIDED|95.0|-3.1|24.9||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||24.9|-3.1|0.1141
71732234|NCT00121641|142979502|SUPERIORITY_OR_OTHER||Difference in Proportions|14.0||||0.0443|TWO_SIDED|95.0|-0.1|27.6||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||27.6|-0.1|0.0443
71732235|NCT00121641|142979502|SUPERIORITY_OR_OTHER||Difference in Proportions|17.1||||0.0133|TWO_SIDED|95.0|2.8|31.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||31.0|2.8|0.0133
71732236|NCT00121641|142979503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6221.0|STANDARD_ERROR_OF_MEAN|1701.3||0.0003|TWO_SIDED|95.0|-9570.0|-2872.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2872|-9570|0.0003
71732237|NCT00121641|142979503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6249.0|STANDARD_ERROR_OF_MEAN|1675.1||0.0002|TWO_SIDED|95.0|-9546.0|-2952.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-2952|-9546|0.0002
71889120|NCT00364182|143299394|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||0.8|-0.1|0.093
71889121|NCT00364182|143299395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.4|0.000
71732238|NCT00121641|142979503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7437.0|STANDARD_ERROR_OF_MEAN|1707.6|<|0.0001|TWO_SIDED|95.0|-10798.0|-4076.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment|||-4076|-10798|<.0001
71732239|NCT01184417|142979546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|||||TWO_SIDED|95.0|4.0|32.0||||||||32|4|
71732240|NCT01184417|142979547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|4.0|49.0||||||||49|4|
71732241|NCT01184417|142979548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.0|||||TWO_SIDED|95.0|-4.0|82.0||||||||82|-4|
71732242|NCT01184417|142979550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-11.0|23.0||||||||23|-11|
71732243|NCT01355796|142979554|SUPERIORITY||Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|95.0|-1.76|4.75|||Mixed Models Analysis|||||4.75|-1.76|<0.05
71732244|NCT00128713|142979584|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
71732245|NCT00128713|142979584|SUPERIORITY_OR_OTHER|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.83
71732246|NCT00128713|142979584|SUPERIORITY_OR_OTHER|||||||0.66||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.||||||0.66
71732247|NCT00128713|142979585|SUPERIORITY_OR_OTHER|||||||0.02||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.02
71732248|NCT00128713|142979585|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71732249|NCT00128713|142979585|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71732250|NCT00128713|142979586|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71732251|NCT00128713|142979586|SUPERIORITY_OR_OTHER||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71732252|NCT00128713|142979586|SUPERIORITY_OR_OTHER|||||||0.16||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.16
71831519|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 26|||0.172|-0.027|0.152
71659104|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|4.06|||<|0.001|TWO_SIDED|95.0|3.25|4.88|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.88|3.25|<0.001
71732253|NCT00128713|142979588|SUPERIORITY_OR_OTHER|||||||0.51||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.51
71732254|NCT00128713|142979588|SUPERIORITY_OR_OTHER|||||||0.82||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.82
71732255|NCT00128713|142979588|SUPERIORITY_OR_OTHER|||||||0.68||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons||||||0.68
71732256|NCT00424268|142979589|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
71732257|NCT00424268|142979590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.0|STANDARD_ERROR_OF_MEAN|15.0|<|0.0001|TWO_SIDED|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||110|51|<0.0001
71732258|NCT00424268|142979591|SUPERIORITY_OR_OTHER||Rate ratio|0.768|STANDARD_ERROR_OF_MEAN|0.157||0.1957|TWO_SIDED|95.0|0.515|1.146||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||1.146|0.515|0.1957
71732259|NCT00424268|142979592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0032|TWO_SIDED|95.0|0.1|0.7||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||0.7|0.1|0.0032
71732260|NCT00424268|142979593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|0.9||0.0051|TWO_SIDED|95.0|-4.5|-0.8||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).||||-0.8|-4.5|0.0051
71889122|NCT00364182|143299395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0|TWO_SIDED|95.0|-0.5|-0.2|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.2|-0.5|0.0000
71889123|NCT00364182|143299395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.002|TWO_SIDED|95.0|-0.5|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.1|-0.5|0.002
71659105|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08|||<|0.001|TWO_SIDED|95.0|2.26|3.9|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.90|2.26|<0.001
71732261|NCT05714943|142979608|SUPERIORITY|||||||0.99|||||||Regression, Linear|||||||.99
71732262|NCT05714943|142979609|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71732263|NCT05714943|142979610|SUPERIORITY|||||||0.09|||||||Regression, Linear|||||||.09
71732264|NCT05714943|142979611|SUPERIORITY|||||||0.57|||||||Regression, Linear|||||||.57
71732265|NCT05714943|142979612|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
71732266|NCT05714943|142979613|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71732267|NCT05714943|142979614|SUPERIORITY|||||||0.97|||||||Regression, Linear|||||||.97
71732268|NCT05714943|142979615|SUPERIORITY|||||||0.21|||||||Regression, Linear|||||||.21
71732269|NCT05714943|142979616|SUPERIORITY|||||||0.27|||||||Regression, Linear|||||||.27
71732270|NCT05714943|142979617|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71732271|NCT05714943|142979618|SUPERIORITY|||||||0.86|||||||Regression, Linear|||||||.86
71732272|NCT05714943|142979619|SUPERIORITY|||||||0.61|||||||Regression, Linear|||||||.61
71732273|NCT05714943|142979620|SUPERIORITY|||||||0.02|||||||Regression, Linear|||||||.02
71732274|NCT05714943|142979621|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
71732275|NCT05714943|142979622|SUPERIORITY|||||||0.08|||||||Regression, Linear|||||||.08
71732276|NCT05714943|142979623|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||.06
71732277|NCT05714943|142979624|SUPERIORITY|||||||0|||||||Regression, Linear|||||||.00
71732278|NCT05714943|142979625|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||.88
71732279|NCT05714943|142979626|SUPERIORITY|||||||0.94|||||||Regression, Linear|||||||.94
71732280|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies \<1250 gm||||0.571
71732281|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.345|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \<1250 gm while anemic||||0.345
71732282|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies \>1250 gm||||0.006
71732283|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies \>1250 gm while anemic||||0.035
71732284|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.910
71732285|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusion||||0.850
71732286|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.507|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.507
71732287|NCT00167388|142979660|SUPERIORITY_OR_OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusion||||0.286
71732288|NCT05501795|142979663|OTHER||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|5.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
71732289|NCT05601102|142979688|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.41|||||||t-test, 2 sided|||||||.41
71732290|NCT05601102|142979689|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.01|||||||t-test, 2 sided|||Anxiety subscale analysis||||.01
71732291|NCT05601102|142979689|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.42|||||||t-test, 2 sided|||Depression subscale||||.42
71732292|NCT05601102|142979690|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.04|||||||t-test, 2 sided|||||||.04
71732293|NCT05601102|142979691|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.15|||||||t-test, 2 sided|||||||.15
71732294|NCT05601102|142979692|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.02|||||||t-test, 2 sided|||||||.02
71732295|NCT05601102|142979693|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.22|||||||t-test, 2 sided|||||||.22
71732296|NCT05601102|142979694|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.29|||||||t-test, 2 sided|||||||.29
71732297|NCT05601102|142979695|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
71732298|NCT05601102|142979696|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||0.6|||||||t-test, 2 sided|||||||.60
71732299|NCT05601102|142979697|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed||||||1|||||||t-test, 2 sided|||||||1.00
71732300|NCT05601102|142979698|EQUIVALENCE|pre- to post-intervention paired t-test, two-tailed|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71732301|NCT04908280|142979702|SUPERIORITY|||||||0.0308|||||||ANOVA|||||||0.0308
71732302|NCT00413010|142979739|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.48||||95.0|-2.16|-0.26|||Mixed Models Analysis|Adjusted for treatment, pooled center baseline, HAM-A total score,time,and treatment-by time|Since an interim analysis was conducted and the sample size was larger than the targeted 173 subjects per group, a critical t-value adjustment was 1.977, yielding an adjusted 95% CI shown above.|Null hypothesis: no difference between Pregabalin (150-600 mg/day) BID and Placebo BID treatment groups. An initial sample size of 173 subjects per double-blind treatment group was calculated to provide at least 90% power to detect an effect size (ie, difference in the true means between 2 treatment groups/standard deviation) of 0.36 for the HAM-A total score change from Baseline using a 2-sided nominal significance level of 4.9%.||-0.26|-2.16|
71772456|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9538|TWO_SIDED|95.0|-0.075|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.071|-0.075|0.9538
71772457|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.8787|TWO_SIDED|95.0|-0.07|0.081||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.081|-0.070|0.8787
71775089|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-3.12||||0.14|TWO_SIDED|95.0|-5.97|-0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.44|-5.97|0.14
71831520|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.114||||0.076|TWO_SIDED|95.0|-0.012|0.241||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 39|||0.241|-0.012|0.076
71732303|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.49||||95.0|-2.3|-0.4|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 1||-0.4|-2.3|
71732304|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.59||||95.0|-2.2|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 2||0.1|-2.2|
71732305|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.62||||95.0|-2.7|-0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 3||-0.2|-2.7|
71732306|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.6|-0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 4||-0.1|-2.6|
71732307|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.68||||95.0|-2.1|0.5|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 5||0.5|-2.1|
71732308|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.67||||95.0|-2.5|0.1|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 6||0.1|-2.5|
71831521|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171||||0.107|TWO_SIDED|95.0|-0.038|0.381||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 52|||0.381|-0.038|0.107
71831522|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.484|TWO_SIDED|95.0|-0.046|0.097||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 2|||0.097|-0.046|0.484
71732309|NCT00413010|142979740|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.77||||95.0|-2.9|0.2|||Mixed Models Analysis|Treatment (tx) adjusted, pooled center baseline HAM-A total score,time,and tx-by time. Degrees of freedom adjusted using Satterthwaite approximation|Difference reflects pregabalin minus placebo.|Week 8||0.2|-2.9|
71732310|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.35||||||95.0|1.37|8.24||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at each week with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||8.24|1.37|
71732311|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||||95.0|0.9|2.87||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.87|0.90|
71659106|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.41|1.56|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.41|<0.001
71659107|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|4.67|||<|0.001|TWO_SIDED|95.0|3.82|5.52|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.52|3.82|<0.001
71659108|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.01|TWO_SIDED|95.0|0.19|1.38|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.38|0.19|0.010
71772458|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002||||0.9544|TWO_SIDED|95.0|-0.062|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.||0.066|-0.062|0.9544
71772459|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.955|TWO_SIDED|95.0|-0.106|0.112||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.112|-0.106|0.9550
71772460|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.8874|TWO_SIDED|95.0|-0.121|0.105||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.105|-0.121|0.8874
71772461|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.9595|TWO_SIDED|95.0|-0.099|0.095||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.||0.095|-0.099|0.9595
71772462|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.3826|TWO_SIDED|95.0|-0.164|0.064||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.064|-0.164|0.3826
71772463|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.3912|TWO_SIDED|95.0|-0.164|0.065||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.065|-0.164|0.3912
71831523|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.256|TWO_SIDED|95.0|-0.027|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 4|||0.100|-0.027|0.256
71831524|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.052||||0.184|TWO_SIDED|95.0|-0.025|0.128||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 8|||0.128|-0.025|0.184
71732312|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15||||||95.0|1.76|5.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||5.66|1.76|
71732313|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|1.06|3.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||3.05|1.06|
71732314|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||||95.0|0.9|2.73||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.73|0.90|
71732315|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||||95.0|0.86|2.66||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.66|0.86|
71732316|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86||||||95.0|1.08|3.22||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responsers at each each with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||3.22|1.08|
71732317|NCT00413010|142979741|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||||95.0|1.12|2.79||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (last observation carried forward, LOCF)||2.79|1.12|
71732318|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.88||||||95.0|0.94|8.8||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 1||8.80|0.94|
71732319|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||||95.0|0.72|3.06||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 2||3.06|0.72|
71732320|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.08||||||95.0|1.09|3.97||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 3||3.97|1.09|
71732321|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||||95.0|0.99|3.28||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 4||3.28|0.99|
71739221|NCT02980133|142991179|SUPERIORITY||LS mean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.1|9.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.||9.8|4.1|<0.001
71831525|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001||||0.97|TWO_SIDED|95.0|-0.077|0.074||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 12|||0.074|-0.077|0.970
71739222|NCT00825812|142991186|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|5.7||||||95.0|4.9|6.6|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|The primary analysis was the comparison of the two treatments among Chinese subjects.||6.6|4.9|
71739223|NCT00825812|142991186|SUPERIORITY_OR_OTHER||ratio of geometric mean time to recovery|4.8||||||97.5|3.7|6.0|||ANOVA|ANOVA, adjusted for center effects, on log transformed times from start of administration of IMP to recovery of the T4/T1 ratio to 0.9.|Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|A key secondary analysis was the comparison of the two treatments among Caucasian subjects.||6.0|3.7|
71659109|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.41|||<|0.001|TWO_SIDED|95.0|1.81|3.01|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.01|1.81|<0.001
71732322|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.82|2.85||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 5||2.85|0.82|
71732323|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||||95.0|0.71|2.48||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 6||2.48|0.71|
71732324|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||||95.0|0.85|2.83||P-value less that the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the HAM-A remission at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8||2.83|0.85|
71772464|NCT01227564|143044992|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.3221|TWO_SIDED|95.0|-0.149|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment\*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.||0.050|-0.149|0.3221
71772465|NCT01227564|143044993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.18||||0.9384|TWO_SIDED|95.0|-1197.07|1293.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1293.42|-1197.07|0.9384
71772466|NCT01227564|143044993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|581.98||||0.3945|TWO_SIDED|95.0|-778.17|1942.13||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1942.13|-778.17|0.3945
71772467|NCT01227564|143044993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|315.08||||0.5773|TWO_SIDED|95.0|-812.15|1442.3||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1442.30|-812.15|0.5773
71772468|NCT01227564|143044994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.16||||0.5818|TWO_SIDED|95.0|-63.31|111.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||111.62|-63.31|0.5818
71772469|NCT01227564|143044994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.42||||0.0648|TWO_SIDED|95.0|-5.37|174.21||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||174.21|-5.37|0.0648
71659110|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.89|||<|0.001|TWO_SIDED|95.0|3.04|4.74|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.74|3.04|<0.001
71732325|NCT00413010|142979742|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||||95.0|0.92|2.53|||Regression, Logistic|Based on fitting a logistic regression on the HAM-A responders at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8 Last Observation Carried Foward (LOCF)||2.53|0.92|
71732326|NCT00413010|142979743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0137||||||P-value corresponds to the 2-sided log-rank test.|Log Rank|2-sided log-rank test||Kaplan Meier product limit estimate for calculating median time in days to onset sustained HAM-A Improvement.||||0.0137
71732327|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||||95.0|0.96|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic|Based on fitting a logistic regression on the CGI-I responders at Week 8 with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1||2.47|0.96|
71889124|NCT00364182|143299395|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.031|TWO_SIDED|95.0|-0.5|0.0|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).||-0.0|-0.5|0.031
71732328|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.58||||||95.0|1.01|2.47||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2||2.47|1.01|
71732329|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||||95.0|1.09|2.82||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3||2.82|1.09|
71732330|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||||95.0|0.77|2.05||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4||2.05|0.77|
71732331|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||||95.0|0.72|2.11||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5||2.11|0.72|
71732332|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||||95.0|0.84|2.5|||Regression, Logistic|P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6||2.50|0.84|
71732333|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||||95.0|0.61|1.84||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8||1.84|0.61|
71732334|NCT00413010|142979744|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||||95.0|0.71|1.76||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Regression, Logistic||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (LOCF) Last Observation Carried Forward||1.76|0.71|
71732335|NCT00413010|142979745|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||||95.0|1.07|2.3||P-value less than the nominal 0.05 level is suggestive of a treatment difference; P-value corresponds to Wald's Chi square test.|Cumulative Logit Model|Based on fitting a logistic regression model for ordinal response of CGI-S scores at Week 8 (LOCF) with treatment and center in the model.|The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. The odds of having an increasingly better response for pregabalin relative to the odds of having an increasingly better response for placebo.|Week 8 Last Observation Carried Forward (LOCF)||2.30|1.07|
71732336|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||||95.0|-1.5|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 1||0.0|-1.5|
71732337|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||||95.0|-1.5|0.2|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 2||0.2|-1.5|
71732338|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||||95.0|-1.6|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 3||0.1|-1.6|
71772470|NCT01227564|143044994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.29||||0.1672|TWO_SIDED|95.0|-23.47|132.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||132.05|-23.47|0.1672
71772471|NCT01227564|143044995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.3106|TWO_SIDED|95.0|-9.94|3.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||3.22|-9.94|0.3106
71659111|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.11|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.11|1.40|<0.001
71732339|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||||95.0|-2.1|-0.6|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 4||-0.6|-2.1|
71732340|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-1.3|0.5|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 5||0.5|-1.3|
71772472|NCT01227564|143044995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.1876|TWO_SIDED|95.0|-11.28|2.27||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||2.27|-11.28|0.1876
71732341|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||||95.0|-1.8|0.0|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 6||0.0|-1.8|
71732342|NCT00413010|142979746|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||||95.0|-2.1|0.1|||ANCOVA|Repeated analysis of covariance heterogeneous auto-regressive w/ tx center wk \& tx by wk fixed effects; Baseline HAM-D total score covariate in model.|Difference is pregabalin minus placebo.|Week 8||0.1|-2.1|
71732343|NCT01189292|142979747|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.0||||0.001|TWO_SIDED|95.0|12.0|42.0|||Chi-squared|||null hypothesis: Incidence of PONV is the same in both treatment arms||42|12|0.001
71732344|NCT01189292|142979748|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.0||||0.006|TWO_SIDED|95.0|7.0|40.0|||Chi-squared|||per protocol analysis||40|7|0.006
71732345|NCT01189292|142979751|SUPERIORITY_OR_OTHER|||||||0.674|TWO_SIDED||||||Mixed Models Analysis|mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)||||||0.674
71732346|NCT01189292|142979752|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.835
71889125|NCT00364182|143299399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.544|TWO_SIDED|95.0|-9.2|4.9|||ANOVA|||||4.9|-9.2|0.544
71732347|NCT05432167|142979755|SUPERIORITY||Mean Difference (Final Values)|-8.08|STANDARD_ERROR_OF_MEAN|2.676||0.003|TWO_SIDED|95.0|-13.36|-2.79|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.79|-13.36|0.003
71732348|NCT05432167|142979756|SUPERIORITY||Mean Difference (Final Values)|-7.22|STANDARD_ERROR_OF_MEAN|3.051||0.019|TWO_SIDED|95.0|-13.24|-1.19|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-1.19|-13.24|0.019
71732349|NCT05432167|142979757|SUPERIORITY||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|3.098||0.004|TWO_SIDED|95.0|-15.1|-2.87|||Mixed Models Analysis|||The analysis was performed using a mixed-effect model for repeated measures including fixed effects for treatment, visit, stratification variables (SGLT2 inhibitor use and CKD category), and the treatment-by-visit interaction, along with a covariate of the baseline seated SBP value and the baseline seated SBP by visit interaction.||-2.87|-15.10|0.004
71732350|NCT00140842|142979774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.0|STANDARD_DEVIATION|16.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.||||<0.05
71732351|NCT00140842|142979775|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|23.7|STANDARD_DEVIATION|12.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no difference between the groups for visceral adipose tissue||||<0.05
71732352|NCT02690649|142979788|SUPERIORITY||estimated adherence rate for the interve|94.0||||0.28|TWO_SIDED|95.0|92.0|95.0|||Regression, Linear|||estimated adherence rate for the intervention group Generalized linear models were used to test the effect of the intervention on medication adherence. These generalized linear models used a Poisson distribution to estimate the rate of adherence with the log of total prescribed doses as an offset term in the linear predictor.||95|92|0.28
71732353|NCT02690649|142979789|SUPERIORITY||||||<|0.001||||||A negative binomial distribution because the outcome was a count variable and it was over-dispersed.|Regression, Linear|Age, previous patient portal logins, and gender were used as co-variates in the model.||||||<0.001
71732354|NCT02690649|142979790|SUPERIORITY||Slope|-0.61||||0.03|TWO_SIDED|95.0|-1.14|-0.07||baseline AF knowledge, gender, age, and educational level were all used as co-variates.|Regression, Linear|generalized linear model tested whether AF knowledge at study completion was related to baseline AF knowledge, gender, age, and educational level||||-0.07|-1.14|0.03
71732355|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3598|TWO_SIDED|95.0|0.53|1.26|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.26|0.53|0.3598
71732356|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.6544|TWO_SIDED|95.0|0.59|1.39|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.39|0.59|0.6544
71732357|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.64|1.58|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.58|0.64|0.9958
71732358|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6276|TWO_SIDED|95.0|0.59|1.37|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.37|0.59|0.6276
71732359|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8819|TWO_SIDED|95.0|0.63|1.49|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.49|0.63|0.8819
71732360|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7197|TWO_SIDED|95.0|0.6|1.42|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.42|0.60|0.7197
71732361|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6204|TWO_SIDED|95.0|0.73|1.7|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.70|0.73|0.6204
71732362|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4779|TWO_SIDED|95.0|0.75|1.84|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.84|0.75|0.4779
71732363|NCT00907296|142979792|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9952|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9952
71732364|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.1713|TWO_SIDED|95.0|0.47|1.14|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.14|0.47|0.1713
71732365|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9958|TWO_SIDED|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.53|0.65|0.9958
71732366|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.295|TWO_SIDED|95.0|0.81|1.97|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.97|0.81|0.2950
71732367|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0844|TWO_SIDED|95.0|0.44|1.05|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.05|0.44|0.0844
71732368|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3225|TWO_SIDED|95.0|0.52|1.24|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.24|0.52|0.3225
71732369|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.4754|TWO_SIDED|95.0|0.76|1.81|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.81|0.76|0.4754
71889126|NCT00364182|143299399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.592|TWO_SIDED|95.0|-7.5|4.3|||ANOVA|||||4.3|-7.5|0.592
71732370|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5578|TWO_SIDED|95.0|0.74|1.75|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.75|0.74|0.5578
71732371|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.1864|TWO_SIDED|95.0|0.87|2.07|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||2.07|0.87|0.1864
71732372|NCT00907296|142979795|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8488|TWO_SIDED|95.0|0.68|1.59|||Cox proportional hazard model||A hazard ratio \> 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.||1.59|0.68|0.8488
71732373|NCT04135859|142979806|SUPERIORITY||Mean Difference (Final Values)|10.3||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||.023
71659112|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|1.02|2.23|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.23|1.02|<0.001
71732374|NCT04135859|142979807|SUPERIORITY||Mean Difference (Final Values)|-59.0||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
71732375|NCT04135859|142979808|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.43|TWO_SIDED||||||Mixed Models Analysis|||||||.43
71732376|NCT03242018|142979809|SUPERIORITY||Difference in Least Square (LS) Means|-0.29|STANDARD_ERROR_OF_MEAN|0.173||0.0962|TWO_SIDED|95.0|-0.628|0.051|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.051|-0.628|0.0962
71732377|NCT03242018|142979810|SUPERIORITY||Difference in LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.196||0.8124|TWO_SIDED|95.0|-0.338|0.431|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.431|-0.338|0.8124
71732378|NCT03242018|142979811|SUPERIORITY||Difference in LS Means|-0.361|STANDARD_ERROR_OF_MEAN|0.6033||0.5501|TWO_SIDED|95.0|-1.5431|0.822|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.8220|-1.5431|0.5501
71732379|NCT03242018|142979811|SUPERIORITY||Difference in LS Means|-0.714|STANDARD_ERROR_OF_MEAN|0.5298||0.1779|TWO_SIDED|95.0|-1.7524|0.3246|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline FPG as a covariate.||0.3246|-1.7524|0.1779
71732380|NCT03242018|142979812|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.703||0.2432|TWO_SIDED|95.0|-2.197|0.557|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||0.557|-2.197|0.2432
71732381|NCT03242018|142979812|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.715||0.0487|TWO_SIDED|95.0|-2.81|-0.008|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.008|-2.810|0.0487
71831526|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.608|TWO_SIDED|95.0|-0.07|0.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 18|||0.120|-0.070|0.608
71831527|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084||||0.071|TWO_SIDED|95.0|-0.007|0.175||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 26|||0.175|-0.007|0.071
71831528|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.622|TWO_SIDED|95.0|-0.085|0.141||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 39|||0.141|-0.085|0.622
71831529|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.102||||0.277|TWO_SIDED|95.0|-0.086|0.291||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 52|||0.291|-0.086|0.277
71831530|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.241|TWO_SIDED|95.0|-0.038|0.15||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 2|||0.150|-0.038|0.241
71831531|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.348|TWO_SIDED|95.0|-0.049|0.14|||MMRM||FVC Pre-dose, Week 4|||0.140|-0.049|0.348
71889127|NCT00364182|143299399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.131|TWO_SIDED|95.0|-1.1|8.4|||ANOVA|||||8.4|-1.1|0.131
71889128|NCT01261559|143299402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|10.0||0.003|TWO_SIDED|95.0|4.0|25.0|||Regression, Linear|A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.||Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.||25|4|0.003
71889129|NCT02921425|143299411|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||.003
71732382|NCT03242018|142979813|SUPERIORITY||Difference in LS Means|-2.14|STANDARD_ERROR_OF_MEAN|2.515||0.3954|TWO_SIDED|95.0|-7.066|2.792|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||2.792|-7.066|0.3954
71732383|NCT03242018|142979813|SUPERIORITY||Difference in LS Means|-4.4|STANDARD_ERROR_OF_MEAN|2.442||0.0716|TWO_SIDED|95.0|-9.185|0.386|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.386|-9.185|0.0716
71732384|NCT03242018|142979814|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|2.103||0.1232|TWO_SIDED|95.0|-7.365|0.881|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.881|-7.365|0.1232
71889130|NCT02921425|143299413|OTHER|||||||0.007|||||||t-test, 2 sided|||||||.007
71732385|NCT03242018|142979814|SUPERIORITY||Difference in LS Means|-5.36|STANDARD_ERROR_OF_MEAN|2.077||0.0098|TWO_SIDED|95.0|-9.433|-1.292|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.292|-9.433|0.0098
71659113|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|4.53|||<|0.001|TWO_SIDED|95.0|3.65|5.4|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.40|3.65|<0.001
71732386|NCT03242018|142979815|SUPERIORITY||Percent Difference|-20.37||||0.222|TWO_SIDED|95.0|-44.75|14.77|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||14.77|-44.75|0.222
71732387|NCT03242018|142979815|SUPERIORITY||Percent Difference|-21.17||||0.1965|TWO_SIDED|95.0|-45.05|13.1|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and log-transformed baseline UACR as a covariate.||13.10|-45.05|0.1965
71732388|NCT03242018|142979816|SUPERIORITY||Percentage Difference|3.2||||0.242|TWO_SIDED|95.0|-2.17|8.66|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||8.66|-2.17|0.2420
71732389|NCT03242018|142979816|SUPERIORITY||Percentage Difference|6.5||||0.0513|TWO_SIDED|95.0|0.04|12.93|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||12.93|0.04|0.0513
71732390|NCT03242018|142979817|SUPERIORITY||Percentage Difference|12.0||||0.0066|TWO_SIDED|95.0|3.48|20.61|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||20.61|3.48|0.0066
71732391|NCT03242018|142979817|SUPERIORITY||Percentage Difference|13.0||||0.0043|TWO_SIDED|95.0|4.28|21.75|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at screening.||21.75|4.28|0.0043
71732392|NCT02968914|142979830|SUPERIORITY||Geometric mean ratio (%)|94.46|||||TWO_SIDED|90.0|88.16|101.21|||ANOVA|||||101.21|88.16|
71732393|NCT02968914|142979831|SUPERIORITY||Geometric mean ratio (%)|92.83|||||TWO_SIDED|90.0|87.41|98.58|||ANOVA|||||98.58|87.41|
71732394|NCT02968914|142979832|SUPERIORITY||Geometric mean ratio (%)|92.34|||||TWO_SIDED|90.0|86.34|98.75|||ANOVA|||||98.75|86.34|
71732395|NCT02636946|142979848|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0166|TWO_SIDED|95.0|-1.28|-0.13|||MMRM|||Change from Baseline at Week 4: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||-0.13|-1.28|0.0166
71732396|NCT02636946|142979849|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.29||0.0735|TWO_SIDED|95.0|-1.09|0.05|||MMRM|||Change from Baseline at Week 12: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.05|-1.09|0.0735
71732397|NCT02636946|142979850|NON_INFERIORITY|MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.|Least-squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3928|TWO_SIDED|95.0|-0.81|0.32|||MMRM|||Change from Baseline at Week 24: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).||0.32|-0.81|0.3928
71732398|NCT01792518|142979878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.78|-0.43|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change in HbA1c is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline HbA1c by visit and baseline log10 (UACR) by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||-0.43|-0.78|<0.0001
71732399|NCT01792518|142979879|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.94||||0.1954|TWO_SIDED|95.0|0.85|1.03|||ANCOVA||Ratio of relative change for Linagliptin 5 mg over placebo is presented.|Superiority of Linagliptin 5 mg vs. placebo: change in UACR is analysed using analysis of covariance model. Model includes baseline HbA1c and baseline log10 (UACR) as linear covariates and treatment as fixed effect.||1.03|0.85|0.1954
71889131|NCT02921425|143299414|OTHER|||||||0.026|||||||t-test, 2 sided|||||||.026
71659114|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.009|TWO_SIDED|95.0|0.21|1.43|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.43|0.21|0.009
71732400|NCT01792518|142979880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|2.7||0.3306|TWO_SIDED|95.0|-7.95|2.68|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Change in eGFR is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline eGFR, baseline HbA1c by visit, baseline log10 (UACR) by visit and baseline eGFR by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.||2.68|-7.95|0.3306
71659115|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.42|||<|0.001|TWO_SIDED|95.0|1.79|3.04|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.04|1.79|<0.001
71732401|NCT04468074|142979881|SUPERIORITY||Mean Difference (Net)|1.0||||0.014|TWO_SIDED||||||Mixed Models Analysis|||||||0.014
71732402|NCT04468074|142979882|SUPERIORITY||Mean Difference (Net)|2.79||||0.0159|TWO_SIDED||||||Mixed Models Analysis|||||||0.0159
71732403|NCT04468074|142979883|SUPERIORITY||Median Difference (Net)|-3.85||||0.0066|TWO_SIDED||||||Mixed Models Analysis|||||||0.0066
71732404|NCT00915148|142979906|SUPERIORITY_OR_OTHER||||||<|0.01||||||The reported p-value corresponds with each area under the ROC assessments|Chi-squared|||In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head - perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.||||<0.01
71732405|NCT00915148|142979907|SUPERIORITY_OR_OTHER||||||<|0.01||||||the reported p-value corresponds with each log rank comparison|Log Rank|||"Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~1. women with fetal head-perineum distance ≤40 mm vs. women with distance \>40 mm measured with 2D ultrasound.~2. women with angle of progression ≥110 degrees vs. women with angle \<110 degrees measured with 2D ultrasound"||||<0.01
71889132|NCT02921425|143299416|OTHER|||||||0.003||||||systolic blood pressure|t-test, 2 sided|||||||.003
71889133|NCT02921425|143299416|OTHER|||||||0.001|||||||t-test, 2 sided|||diastolic blood pressure||||.001
71889134|NCT02921425|143299418|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||.019
71889135|NCT03403400|143299422|EQUIVALENCE|Comparison of variance|Test Statistics|0.893||||0.64|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between groups in mCTSIB Ha: There is a significant difference between groups in mCTSIB||||.640
71659116|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.71|||<|0.001|TWO_SIDED|95.0|2.83|4.58|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.58|2.83|<0.001
71659117|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.23|2.99|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.99|1.23|<0.001
71659118|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.97|2.22|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.22|0.97|<0.001
71659119|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|4.27|||<|0.001|TWO_SIDED|95.0|3.37|5.17|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||5.17|3.37|<0.001
71732406|NCT00249613|142979909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.21|0.79||Odds ratio is 0.40, confidence interval is 0.21-0.79.|Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only participants are less likely than Mixed-Gender participants to engage in criminal activities.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.79|0.21|0.01
71732407|NCT00249613|142979910|SUPERIORITY_OR_OTHER||Beta coefficient|-0.7|STANDARD_ERROR_OF_MEAN|0.72||0.33|TWO_SIDED|95.0|-2.11|0.7|||Generalized estimating equations (GEE)|||Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.||0.70|-2.11|0.33
71889136|NCT03403400|143299422|EQUIVALENCE|Comparison of variance|Test Statistics|0.196||||0.18|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in mCTSIB Ha: There is a significant difference between the prescribed walking group and the control group in mCTSIB||||.18
71889137|NCT03403400|143299423|EQUIVALENCE|comparison of variance|Test Statistics|0.803||||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in TUG Ha: There is a significant difference between the groups in TUG||||.67
71889138|NCT03403400|143299423|EQUIVALENCE|comparison of variance|Test Statistics|0.14||||0.71|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in TUG between the prescribed walking and control group Ha: There is a significant difference in TUG between the prescribed walking and control group||||.71
71732408|NCT00249613|142979911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42|STANDARD_ERROR_OF_MEAN|0.34||0.01|TWO_SIDED|95.0|0.22|0.82|||Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only treatment participants are less likely than the Mixed-Gender group to use drugs or alcohol during the 30 days prior to the 12-Mo follow-up.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.||0.82|0.22|0.01
71732409|NCT01264770|142979933|SUPERIORITY_OR_OTHER||Treatment difference|0.56||||0.006|TWO_SIDED|90.0|0.23|0.9|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.90|0.23|0.006
71732410|NCT01264770|142979933|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.022|TWO_SIDED|90.0|0.14|0.84|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.84|0.14|0.022
71732411|NCT01264770|142979933|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.28|TWO_SIDED|90.0|-0.12|0.56|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||0.56|-0.12|0.280
71732412|NCT01264770|142979934|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.005|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.005
71732413|NCT01264770|142979934|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.61||||0.02|TWO_SIDED|80.0|-0.94|-0.27|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.27|-0.94|0.020
71732414|NCT01264770|142979934|NON_INFERIORITY_OR_EQUIVALENCE|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.004|TWO_SIDED|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.||-0.40|-1.04|0.004
71732415|NCT01264770|142979935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05||||0.005|TWO_SIDED|90.0|1.59|5.86|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.86|1.59|0.005
71772473|NCT01227564|143044995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.93||||0.1742|TWO_SIDED|95.0|-9.66|1.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||1.79|-9.66|0.1742
71732416|NCT01264770|142979935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.11|||<|0.001|TWO_SIDED|90.0|2.1|8.05|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.05|2.10|<0.001
71732417|NCT01264770|142979935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.335|TWO_SIDED|90.0|0.76|2.83|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.76|0.335
71772474|NCT01227564|143044996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.36||||0.4089|TWO_SIDED|95.0|-103.52|42.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||42.81|-103.52|0.4089
71831532|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.138|TWO_SIDED|95.0|-0.024|0.169||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 8|||0.169|-0.024|0.138
71772475|NCT01227564|143044996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.4||||0.0327|TWO_SIDED|95.0|-159.69|-7.11||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||-7.11|-159.69|0.0327
71772476|NCT01227564|143044996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.88||||0.0801|TWO_SIDED|95.0|-120.82|7.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.||7.06|-120.82|0.0801
71772477|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.78||||0.4892|TWO_SIDED|95.0|-37.15|76.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||76.71|-37.15|0.4892
71772478|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.06||||0.0915|TWO_SIDED|95.0|-8.51|110.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||110.63|-8.51|0.0915
71732418|NCT01264770|142979936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.007|TWO_SIDED|90.0|0.2|0.68|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.68|0.20|0.007
71732419|NCT01264770|142979936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.051|TWO_SIDED|90.0|0.26|0.89|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.89|0.26|0.051
71772479|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.42||||0.1638|TWO_SIDED|95.0|-14.88|85.72||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.||85.72|-14.88|0.1638
71772480|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.29||||0.2006|TWO_SIDED|95.0|-54.28|252.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||252.86|-54.28|0.2006
71772481|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|225.63||||0.0067|TWO_SIDED|95.0|65.18|386.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||386.09|65.18|0.0067
71772482|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|162.46||||0.0204|TWO_SIDED|95.0|26.05|298.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||298.87|26.05|0.0204
71772483|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.13||||0.0766|TWO_SIDED|95.0|-12.63|240.89||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||240.89|-12.63|0.0766
71732420|NCT01264770|142979936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.004|TWO_SIDED|90.0|0.2|0.65|||Proportional odds model||An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.65|0.20|0.004
71732421|NCT01264770|142979937|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.29|||<|0.001|TWO_SIDED|90.0|0.17|0.4||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.40|0.17|<0.001
71732422|NCT01264770|142979937|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.43||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|0.18|<0.001
71732423|NCT01264770|142979937|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.19||||0.007|TWO_SIDED|90.0|0.07|0.31||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.31|0.07|0.007
71732424|NCT01264770|142979937|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.16||||0.049|TWO_SIDED|90.0|-0.3|-0.03||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.03|-0.30|0.049
71732425|NCT01264770|142979937|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.803|TWO_SIDED|90.0|-0.16|0.12||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.16|0.803
71732426|NCT01264770|142979937|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.24||||0.003|TWO_SIDED|90.0|-0.37|-0.1||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.10|-0.37|0.003
71732427|NCT01264770|142979938|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.059|TWO_SIDED|90.0|0.01|0.18||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.01|0.059
71732428|NCT01264770|142979938|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.071|TWO_SIDED|90.0|0.01|0.17||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.01|0.071
71732429|NCT01264770|142979938|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.01||||0.758|TWO_SIDED|90.0|-0.05|0.07||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|-0.05|0.758
71732430|NCT01264770|142979938|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.12||||0.114|TWO_SIDED|90.0|-0.24|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-0.24|0.114
71732431|NCT01264770|142979938|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.14||||0.078|TWO_SIDED|90.0|-0.26|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.26|0.078
71732432|NCT01264770|142979938|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.21||||0.003|TWO_SIDED|90.0|-0.32|-0.09||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.09|-0.32|0.003
71831533|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012||||0.813|TWO_SIDED|95.0|-0.111|0.087||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 12|||0.087|-0.111|0.813
71772484|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||413.41|40.23|0.0181
71772485|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||325.63|9.03|0.0387
71831534|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.172|TWO_SIDED|95.0|-0.032|0.177||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 18|||0.177|-0.032|0.172
71772486|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.84||||0.2277|TWO_SIDED|95.0|-69.29|284.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||284.97|-69.29|0.2277
71772487|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.82||||0.0181|TWO_SIDED|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||413.41|40.23|0.0181
71772488|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.33||||0.0387|TWO_SIDED|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||325.63|9.03|0.0387
71831535|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.242|TWO_SIDED|95.0|-0.045|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 26|||0.180|-0.045|0.242
71831536|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.082||||0.267|TWO_SIDED|95.0|-0.063|0.228||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 39|||0.228|-0.063|0.267
71659120|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.012|TWO_SIDED|95.0|0.18|1.44|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.44|0.18|0.012
71831537|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.471|TWO_SIDED|95.0|-0.143|0.309||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 52|||0.309|-0.143|0.471
71831538|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.315|TWO_SIDED|95.0|-0.043|0.132||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 2|||0.132|-0.043|0.315
71732433|NCT01264770|142979939|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.02||||0.46|TWO_SIDED|90.0|-0.07|0.03||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.03|-0.07|0.460
71732434|NCT01264770|142979939|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.0||||0.903|TWO_SIDED|90.0|-0.05|0.06||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.06|-0.05|0.903
71732435|NCT01264770|142979939|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.03||||0.172|TWO_SIDED|90.0|-0.08|0.01||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.01|-0.08|0.172
71732436|NCT01264770|142979939|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.082|TWO_SIDED|90.0|-0.21|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.01|-0.21|0.082
71732437|NCT01264770|142979939|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.11||||0.092|TWO_SIDED|90.0|-0.21|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.00|-0.21|0.092
71732438|NCT01264770|142979939|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.17||||0.002|TWO_SIDED|90.0|-0.27|-0.08||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.08|-0.27|0.002
71732439|NCT01264770|142979940|SUPERIORITY_OR_OTHER||Treatment difference|23.39|||<|0.001|TWO_SIDED|90.0|9.57|40.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||40.00|9.57|<0.001
71732440|NCT01264770|142979940|SUPERIORITY_OR_OTHER||Treatment difference|22.97||||0.006|TWO_SIDED|90.0|7.84|38.34|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||38.34|7.84|0.006
71732441|NCT01264770|142979940|SUPERIORITY_OR_OTHER||Treatment difference|5.72||||0.234|TWO_SIDED|90.0|-3.2|21.68|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||21.68|-3.20|0.234
71732442|NCT01264770|142979941|SUPERIORITY_OR_OTHER||Treatment difference|-13.72||||0.03|TWO_SIDED|90.0|-25.01|0.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.00|-25.01|0.030
71732443|NCT01264770|142979941|SUPERIORITY_OR_OTHER||Treatment difference|-9.49||||0.207|TWO_SIDED|90.0|-25.0|6.96|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||6.96|-25.00|0.207
71732444|NCT01264770|142979941|SUPERIORITY_OR_OTHER||Treatment difference|-19.53||||0.002|TWO_SIDED|90.0|-30.01|-6.25|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-6.25|-30.01|0.002
71775090|NCT01920555|143050512|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.72|TWO_SIDED|95.0|-4.65|0.96||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.96|-4.65|0.72
71732445|NCT01264770|142979942|SUPERIORITY_OR_OTHER||Treatment difference|0.24||||0.007|TWO_SIDED|90.0|0.09|0.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.38|0.09|0.007
71831539|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054||||0.143|TWO_SIDED|95.0|-0.018|0.126||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 4|||0.126|-0.018|0.143
71732446|NCT01264770|142979942|SUPERIORITY_OR_OTHER||Treatment difference|0.22||||0.016|TWO_SIDED|90.0|0.07|0.37|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.37|0.07|0.016
71732447|NCT01264770|142979942|SUPERIORITY_OR_OTHER||Treatment difference|0.14||||0.094|TWO_SIDED|90.0|0.0|0.29|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.00|0.094
71732448|NCT01264770|142979943|SUPERIORITY_OR_OTHER||Treatment difference|-0.2||||0.043|TWO_SIDED|90.0|-0.36|-0.04|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.04|-0.36|0.043
71732449|NCT01264770|142979943|SUPERIORITY_OR_OTHER||Treatment difference|-0.14||||0.158|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.02|-0.31|0.158
71732450|NCT01264770|142979943|SUPERIORITY_OR_OTHER||Treatment difference|-0.32||||0.001|TWO_SIDED|90.0|-0.47|-0.16|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.16|-0.47|0.001
71772489|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.92||||0.0747|TWO_SIDED|95.0|-14.62|298.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||298.45|-14.62|0.0747
71772490|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.4||||0.0151|TWO_SIDED|95.0|41.02|367.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||367.79|41.02|0.0151
71732451|NCT01264770|142979944|SUPERIORITY_OR_OTHER||Treatment difference|-2.77||||0.05|TWO_SIDED|90.0|-5.08|-0.45|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.45|-5.08|0.050
71732452|NCT01264770|142979944|SUPERIORITY_OR_OTHER||Treatment difference|-1.33||||0.36|TWO_SIDED|90.0|-3.73|1.06|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.06|-3.73|0.360
71732453|NCT01264770|142979944|SUPERIORITY_OR_OTHER||Treatment difference|-2.99||||0.032|TWO_SIDED|90.0|-5.29|-0.7|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||-0.70|-5.29|0.032
71732454|NCT01264770|142979945|SUPERIORITY_OR_OTHER||Treatment difference|-1.02||||0.568|TWO_SIDED|90.0|-3.95|1.92|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.92|-3.95|0.568
71732455|NCT01264770|142979945|SUPERIORITY_OR_OTHER||Treatment difference|-1.66||||0.368|TWO_SIDED|90.0|-4.69|1.38|||ANCOVA|Including terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||1.38|-4.69|0.368
71831540|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072||||0.111|TWO_SIDED|95.0|-0.017|0.16||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 8|||0.160|-0.017|0.111
71831541|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.012||||0.783|TWO_SIDED|95.0|-0.075|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 12|||0.100|-0.075|0.783
71831542|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.059||||0.283|TWO_SIDED|95.0|-0.049|0.167||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 18|||0.167|-0.049|0.283
71831543|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.038|TWO_SIDED|95.0|0.008|0.267||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 26|||0.267|0.008|0.038
71831544|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.467|TWO_SIDED|95.0|-0.083|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 39|||0.180|-0.083|0.467
71889139|NCT03403400|143299424|EQUIVALENCE|Comparison of variance|Test Statistics|0.803|STANDARD_DEVIATION|1.79||0.67|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DGI Ha: There is a significant difference between the groups in DGI||||.67
71659121|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.72|3.0|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.00|1.72|<0.001
71732456|NCT01264770|142979945|SUPERIORITY_OR_OTHER||Treatment difference|-2.48||||0.16|TWO_SIDED|90.0|-5.38|0.43|||ANCOVA|Includes terms for baseline as a continuous covariate \& treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) \& pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.43|-5.38|0.160
71732457|NCT00424190|142979949|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.2|6.2|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||6.2|-4.2|
71732458|NCT00351273|142979957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.8||||0.01|TWO_SIDED||||||Fisher Exact|||Difference in the percentages of participants with response between all those who received combination therapy vs. placebo||||0.01
71732459|NCT01672866|142979965|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.2|||||TWO_SIDED|95.0|-1.3|1.0||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.0|-1.3|
71732460|NCT01672866|142979965|SUPERIORITY||Difference in LSMeans [SIM - Placebo]|-0.4|||||TWO_SIDED|95.0|-1.5|0.8||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||0.8|-1.5|
71831545|NCT02299375|143167541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042||||0.64|TWO_SIDED|95.0|-0.138|0.222||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 52|||0.222|-0.138|0.640
71831546|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.661|TWO_SIDED|95.0|-2.08|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 2|||3.27|-2.08|0.661
71889140|NCT03403400|143299424|EQUIVALENCE|comparison of variance|Test Statistics|0.66||||0.42|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the prescribed walking group and the control group in DGI Ha: There is a significant difference between the prescribed walking group and control group in DGI||||.42
71889141|NCT03403400|143299425|EQUIVALENCE|comparison of variance|Test Statistics|4.386||||0.11|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference between the groups in DHI Ha: There is a significant difference between the groups in DHI||||.11
71889142|NCT03403400|143299425|EQUIVALENCE|comparison of variance|Test Statistics|4.351||||0.04|TWO_SIDED||||||Kruskal-Wallis|||Ho: There is no significant difference in DHI between the prescribed walking group and the control group Ha: There is a significant difference in DHI between the prescribed walking group and the control group||||.04
71889143|NCT01171612|143299443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.479|TWO_SIDED|95.0|0.513|2.299|||Chi-squared|||Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery||2.299|0.513|0.479
71889144|NCT01171612|143299443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.638||||0.479|TWO_SIDED|95.0|0.733|3.662|||Chi-squared|||||3.662|0.733|0.479
71732461|NCT01672866|142979966|SUPERIORITY|||||||0.73|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.73
71732462|NCT01672866|142979966|SUPERIORITY|||||||0.85|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.||||0.85
71732463|NCT02033213|142979977|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.410
71732464|NCT02033213|142979977|SUPERIORITY_OR_OTHER|||||||0.621||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.621
71732465|NCT02033213|142979978|SUPERIORITY_OR_OTHER|||||||0.791||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.||||0.791
71732466|NCT02033213|142979978|SUPERIORITY_OR_OTHER|||||||0.41||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.410
71732467|NCT02033213|142979979|SUPERIORITY_OR_OTHER|||||||0.322||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement aws assessed at 10 minutes time point.||||0.322
71732468|NCT02033213|142979979|SUPERIORITY_OR_OTHER|||||||0.574||||||P \< 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.||||0.574
71732469|NCT02033213|142979980|SUPERIORITY_OR_OTHER|||||||0.03||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.030
71831547|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44||||0.074|TWO_SIDED|95.0|-0.24|5.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 6|||5.12|-0.24|0.074
71732470|NCT02033213|142979980|SUPERIORITY_OR_OTHER|||||||0.096||||||P \< 0.05 was considered significant.|t-test, 1 sided|||||||0.096
71732471|NCT02033213|142979981|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 1 sided|||||||0.362
71732472|NCT02033213|142979982|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.020
71732473|NCT01073930|142980028|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|9.8|||||ONE_SIDED|97.5|3.4||||||||||3.4|
71732474|NCT01073930|142980029|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|10.7|||||ONE_SIDED|97.5|4.9|||||||Ascending colon comparison|||4.9|
71732475|NCT01073930|142980029|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|6.6|||||ONE_SIDED|97.5|1.6|||||||Mid colon comparison|||1.6|
71732476|NCT01073930|142980029|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|5.2|||||ONE_SIDED|97.5|0.4|||||||Recto-sigmoid colon comparison|||0.4|
71732477|NCT01073930|142980029|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|11.4|||||ONE_SIDED|97.5|5.2|||||||Overall: Ascending, mid, and recto-sigmoid colon comparison|||5.2|
71732478|NCT01073930|142980030|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71732479|NCT01073930|142980031|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71732480|NCT01073930|142980032|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71732481|NCT01073930|142980033|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71732482|NCT01073930|142980034|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71732483|NCT01073930|142980035|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71732484|NCT01266590|142980042|SUPERIORITY_OR_OTHER|||||||0.0664||95.0|||||Wilcoxon Signed Rank|||||||0.0664
71732485|NCT02198794|142980061|OTHER||Least Square (LS) Mean Difference|-0.6||||0.121|TWO_SIDED|95.0|-1.42|0.17||Threshold for significance at 0.05 level.|ANCOVA|||The statistical model was an analysis of covariance (ANCOVA) with treatment group and dopamine receptor antagonist status at the pre-withdrawal visit as fixed effects and the pre-withdrawal visit value as a covariate.||0.17|-1.42|0.121
71732486|NCT02252965|142980089|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin of this efficacy outcome measure is -0.4%.|Least Squares (LS) Mean Difference|0.03|||||TWO_SIDED|95.0|-0.1|0.17||||||||0.17|-0.10|
71732487|NCT02252965|142980090|SUPERIORITY_OR_OTHER||Percentage difference|-1.52||||0.674|TWO_SIDED|95.0|-8.6|5.56|||Mantel Haenszel|||||5.56|-8.60|0.674
71732488|NCT05149313|142980126|SUPERIORITY||Difference in percentages|27.88|||<|0.0001|TWO_SIDED|95.0|15.63|40.14|||Cochran-Mantel-Haenszel|||||40.14|15.63|<0.0001
71732489|NCT05149313|142980127|SUPERIORITY||Difference in percentages|17.8||||0.0052|TWO_SIDED|95.0|7.03|28.57|||Cochran-Mantel-Haenszel|||||28.57|7.03|0.0052
71732490|NCT05149313|142980128|SUPERIORITY||Difference in percentages|18.15||||0.0114|TWO_SIDED|95.0|5.47|30.83|||Cochran-Mantel-Haenszel|||||30.83|5.47|0.0114
71889145|NCT04666038|143299474|SUPERIORITY||Hazard Ratio (HR)|0.536||||0.0002|TWO_SIDED|95.0|0.385|0.746||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The Hazard Ratio (HR) \& 95% confidence interval (CI) were estimated from a stratified Cox proportional hazards model.|||0.746|0.385|0.0002
71659122|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.47|||<|0.001|TWO_SIDED|95.0|2.57|4.36|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.36|2.57|<0.001
71732491|NCT04736628|142980158|OTHER||Mean Difference (Net)|-0.228||||0.0179|TWO_SIDED|95.0|-0.417|-0.04|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.040|-0.417|0.0179
71732492|NCT04736628|142980158|OTHER||Mean Difference (Net)|-0.209||||0.0307|TWO_SIDED|95.0|-0.398|-0.02|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.020|-0.398|0.0307
71732493|NCT04736628|142980158|OTHER||Mean Difference (Net)|-0.235||||0.0151|TWO_SIDED|95.0|-0.425|-0.046|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.046|-0.425|0.0151
71732494|NCT04736628|142980158|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0053|||||||MCP-Mod E-max model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0053
71732495|NCT04736628|142980158|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0102|||||||MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0102
71732496|NCT04736628|142980158|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.023|||||||MCP-Mod linear model fit|Model assumption: no assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0230
71732497|NCT04736628|142980158|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0292|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0292
71739224|NCT00825812|142991186|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds.|median difference (seconds)|7.0||||||97.5|-5.0|21.0|||||Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex).|A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects.||21|-5|
71739225|NCT00483938|142991196|SUPERIORITY_OR_OTHER|||||||0.51|||||||Fisher Exact|||SVR: Group A versus Group B||||0.510
71739226|NCT00483938|142991197|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group C versus Group D||||1.000
71659123|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.82|1.00|<0.001
71732498|NCT04736628|142980158|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||||||0.0468|||||||MCP-Mod Exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of avenciguat and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (Emax, exponential, linear, quadratic, sigmoid emax) while protecting the overall probability of type I error (one-sided alpha of 0.050).~The total daily dose was considered for MCP-Mod analysis (placebo, active avenciguat 3 mg, 6 mg, and 9 mg)."||||0.0468
71732499|NCT04736628|142980159|OTHER||Mean Difference (Net)|-0.217||||0.0327|TWO_SIDED|95.0|-0.416|-0.018|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 1 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.018|-0.416|0.0327
71732500|NCT04736628|142980159|OTHER||Mean Difference (Net)|-0.206||||0.0447|TWO_SIDED|95.0|-0.408|-0.005|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 2 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||-0.005|-0.408|0.0447
71732501|NCT04736628|142980159|OTHER||Mean Difference (Net)|-0.187||||0.0654|TWO_SIDED|95.0|-0.387|0.012|||Mixed-effect Model repeat Measurement||"Least Squares Mean of Avenciguat 3 mg TID - Least Squares Mean of Placebo."|Least Squares Mean differences and 95% confidence intervals were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient.||0.012|-0.387|0.0654
71732502|NCT04736628|142980160|OTHER||Odds Ratio (OR)|2.2||||0.0476|TWO_SIDED|95.0|1.01|4.79||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.79|1.01|0.0476
71732503|NCT04736628|142980160|OTHER||Odds Ratio (OR)|2.72||||0.0119|TWO_SIDED|95.0|1.25|5.94||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||5.94|1.25|0.0119
71732504|NCT04736628|142980160|OTHER||Odds Ratio (OR)|3.43||||0.0019|TWO_SIDED|95.0|1.58|7.45||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||7.45|1.58|0.0019
71732505|NCT04736628|142980161|OTHER||Odds Ratio (OR)|2.13||||0.0497|TWO_SIDED|95.0|1.0|4.55||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 1 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.55|1.00|0.0497
71732506|NCT04736628|142980161|OTHER||Odds Ratio (OR)|2.15||||0.0502|TWO_SIDED|95.0|1.0|4.61||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 2 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.61|1.00|0.0502
71732507|NCT04736628|142980161|OTHER||Odds Ratio (OR)|2.09||||0.0572|TWO_SIDED|95.0|0.98|4.49||Nominal p-value.|Regression, Logistic||Odds ratio (Avenciguat 3 mg TID vs. Placebo).|Treatment and sodium-glucose co-transporter-2 inhibitor (SGLT2i) use at randomization were used as covariates in the logistic regression model.||4.49|0.98|0.0572
71889146|NCT04666038|143299475|SUPERIORITY||Hazard Ratio (HR)|0.475|||<|0.0001|TWO_SIDED|95.0|0.338|0.669||The 2-sided nominal p-value was calculated based on a stratified log-rank test|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.669|0.338|<0.0001
71732508|NCT02046070|142980178|OTHER|||||||0.4859|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.4859
71732509|NCT02046070|142980178|OTHER|||||||0.6757|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.||||0.6757
71732510|NCT02046070|142980179|OTHER|||||||0.9688|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR+PR rate=60% obtained using the one-sided Chi-Square test with alpha=0.10.||||0.9688
71732511|NCT00110461|142980211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.99|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.5|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-3.5|-8.49|<0.0001
71732512|NCT00110461|142980211|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.77|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student's t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.||-5.77|-10.7|<0.0001
71732513|NCT00110461|142980212|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.89|||<|0.0001|TWO_SIDED|95.0|-8.7|-3.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.08|-8.7|<0.0001
71732514|NCT00110461|142980212|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
71732515|NCT00110461|142980213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|9.3|||<|0.0001|TWO_SIDED|95.0|5.77|12.84|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||12.84|5.77|<0.0001
71732516|NCT00110461|142980213|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|11.51|||<|0.0001|TWO_SIDED|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||15.03|7.99|<0.0001
71732517|NCT00110461|142980214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.48|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.48|-1.15|<0.0001
71732518|NCT00110461|142980214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|||<|0.0001||95.0|-1.59|-0.93|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.93|-1.59|<0.0001
71732519|NCT00110461|142980215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.0767|TWO_SIDED|95.0|-4.81|0.25|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.25|-4.81|0.0767
71732520|NCT00110461|142980215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.3515|TWO_SIDED|95.0|-3.69|1.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.32|-3.69|0.3515
71732521|NCT00110461|142980216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.73|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.73|-8.02|<0.0001
71732522|NCT00110461|142980216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.46|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.32|-7.40|<0.0001
71732523|NCT00110461|142980217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||<|0.0001|TWO_SIDED|95.0|-12.3|-5.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-5.43|-12.3|<0.0001
71732524|NCT00110461|142980217|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.0001|TWO_SIDED|95.0|-11.6|-4.83|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-4.83|-11.6|<0.0001
71732525|NCT00110461|142980218|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|||<|0.0001|TWO_SIDED|95.0|5.07|13.93|||t-test, 2 sided|||||13.93|5.07|<0.0001
71732526|NCT00110461|142980218|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|95.0|5.87|14.14|||t-test, 2 sided|||||14.14|5.87|<0.0001
71732527|NCT00110461|142980219|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.0003|TWO_SIDED|95.0|-1.08|-0.33|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.33|-1.08|0.0003
71732528|NCT00110461|142980219|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.66|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.66|-1.41|<0.0001
71732529|NCT00110461|142980220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0878|TWO_SIDED|95.0|-0.54|0.04|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.04|-0.54|0.0878
71732530|NCT00110461|142980220|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.26||||0.0752|TWO_SIDED|95.0|-0.55|0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.03|-0.55|0.0752
71732531|NCT00110461|142980221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2553|TWO_SIDED|95.0|-0.51|0.13|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.13|-0.51|0.2553
71732532|NCT00110461|142980221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0166|TWO_SIDED|95.0|-0.71|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-0.71|0.0166
71732533|NCT00110461|142980222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.51|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.51|-1.16|<0.0001
71732534|NCT00110461|142980222|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.86|-1.51|<0.0001
71732535|NCT00110461|142980223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.4|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.40|-1.13|<0.0001
71732536|NCT00110461|142980223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.6|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.60|-1.33|<0.0001
71732537|NCT00110461|142980224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.92||||0.1729|TWO_SIDED|95.0|-4.69|0.85|||t-test, 2 sided|||||0.85|-4.69|0.1729
71732538|NCT00110461|142980224|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.43||||0.75586|TWO_SIDED|95.0|-3.17|2.31|||t-test, 2 sided|||||2.31|-3.17|0.75586
71732539|NCT00110461|142980225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.61|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.61|-6.90|<0.0001
71732540|NCT00110461|142980225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.5|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.50|-6.78|<0.0001
71732541|NCT00110461|142980226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85||||0.0468|TWO_SIDED|95.0|-3.67|-0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.03|-3.67|0.0468
71732542|NCT00110461|142980226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03||||0.0296|TWO_SIDED|95.0|-3.85|-0.2|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.20|-3.85|0.0296
71732543|NCT00110461|142980227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.1309|TWO_SIDED|95.0|-3.31|0.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.43|-3.31|0.1309
71732544|NCT00110461|142980227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.0058|TWO_SIDED|95.0|-4.51|-0.77|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.77|-4.51|0.0058
71732545|NCT00110461|142980228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.043|TWO_SIDED|95.0|-4.2|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-0.07|-4.20|0.0430
71732546|NCT00110461|142980228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.7696|TWO_SIDED|95.0|-2.37|1.76|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.76|-2.37|0.7696
71732547|NCT00110461|142980229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
71732548|NCT00110461|142980229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.19|TWO_SIDED|95.0|-1.67|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.67|0.19
71739227|NCT00483938|142991197|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||SVR: Group E versus Group F||||1.000
71739228|NCT00483938|142991198|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||ETR: Group A versus Group B||||0.792
71739229|NCT00483938|142991198|SUPERIORITY_OR_OTHER|||||||0.612|||||||Fisher Exact|||ETR: Group C versus Group D||||0.612
71739230|NCT00483938|142991198|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||ETR: Group E versus Group F||||0.490
71659124|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55|||<|0.001|TWO_SIDED|95.0|0.92|2.19|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.19|0.92|<0.001
71732549|NCT00110461|142980230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.9418|TWO_SIDED|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.86|-1.73|0.9418
71732550|NCT00110461|142980230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.8377|TWO_SIDED|95.0|-1.61|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.98|-1.61|0.8377
71732551|NCT00110461|142980231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.3969|TWO_SIDED|95.0|-2.71|1.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||1.08|-2.71|0.3969
71732552|NCT00110461|142980231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.2101|TWO_SIDED|95.0|-3.09|0.68|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||0.68|-3.09|0.2101
71732553|NCT00110461|142980232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.0001|TWO_SIDED|95.0|-10.5|-3.64|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-3.64|-10.5|<0.0001
71732554|NCT00110461|142980232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0014|TWO_SIDED|95.0|-8.94|-2.16|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.||-2.16|-8.94|0.0014
71732555|NCT00110461|142980233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7||||0.0074|TWO_SIDED|95.0|5.01|32.4|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||32.40|5.01|0.0074
71659125|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.68|||<|0.001|TWO_SIDED|95.0|2.76|4.6|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.60|2.76|<0.001
71732556|NCT00110461|142980233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.55|||<|0.0001|TWO_SIDED|95.0|23.41|51.68|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||51.68|23.41|<0.0001
71732557|NCT00110461|142980234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.0009|TWO_SIDED|95.0|9.57|37.24|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||37.24|9.57|0.0009
71732558|NCT00110461|142980234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.96|||<|0.0001|TWO_SIDED|95.0|15.05|42.87|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.||42.87|15.05|<0.0001
71732559|NCT00110461|142980235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.66|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.66|-1.29|<0.0001
71732560|NCT00110461|142980235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.7|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.70|-1.39|<0.0001
71732561|NCT00110461|142980236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.002|TWO_SIDED|95.0|-1.04|-0.24|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.24|-1.04|0.0020
71732562|NCT00110461|142980236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0001|TWO_SIDED|95.0|-1.19|-0.41|||Cochran-Mantel-Haenszel|||||-0.41|-1.19|0.0001
71732563|NCT00110461|142980237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.96|-0.26|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.26|-0.96|0.0010
71732564|NCT00110461|142980237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0053|TWO_SIDED|95.0|-0.85|-0.16|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.16|-0.85|0.0053
71732565|NCT00110461|142980238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.1726|TWO_SIDED|95.0|-0.64|0.11|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||0.11|-0.64|0.1726
71739231|NCT00483938|142991198|SUPERIORITY_OR_OTHER|||||||0.363|||||||Fisher Exact|||Complete EVR: Group C versus Group D||||0.363
71739232|NCT00483938|142991198|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Complete EVR: Group E versus Group F||||1.000
71739442|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.26|||||TWO_SIDED|95.0|0.98|1.63|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.63|0.98|
71659126|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.055|TWO_SIDED|95.0|-0.01|1.27|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.27|-0.01|0.055
71659127|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.19|||<|0.001|TWO_SIDED|95.0|1.54|2.84|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.54|<0.001
71659128|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.05|||<|0.001|TWO_SIDED|95.0|2.14|3.97|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.97|2.14|<0.001
71659129|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.002|TWO_SIDED|95.0|0.57|2.42|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.42|0.57|0.002
71659130|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|0.91|2.21|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.21|0.91|<0.001
71659131|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.17|4.03|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||4.03|2.17|<0.001
71659132|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.049|TWO_SIDED|95.0|0.0|1.3|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.30|0.00|0.049
71659133|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|||<|0.001|TWO_SIDED|95.0|1.27|2.59|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.59|1.27|<0.001
71659134|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.44|||<|0.001|TWO_SIDED|95.0|1.52|3.37|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.37|1.52|<0.001
71659135|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.015|TWO_SIDED|95.0|0.23|2.1|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.10|0.23|0.015
71659136|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|0.62|1.94|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.62|<0.001
71659137|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48|||<|0.001|TWO_SIDED|95.0|1.56|3.4|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||3.40|1.56|<0.001
71659138|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.087|TWO_SIDED|95.0|-0.08|1.2|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.20|-0.08|0.087
71659139|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.47|||<|0.001|TWO_SIDED|95.0|0.82|2.12|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.82|<0.001
71659140|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.92|||<|0.001|TWO_SIDED|95.0|1.0|2.84|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.84|1.00|<0.001
71659141|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01||||0.032|TWO_SIDED|95.0|0.09|1.94|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.94|0.09|0.032
71659142|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.006|TWO_SIDED|95.0|0.26|1.56|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.56|0.26|0.006
71659143|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.75|||<|0.001|TWO_SIDED|95.0|0.85|2.66|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.66|0.85|<0.001
71732566|NCT00110461|142980238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0113|TWO_SIDED|95.0|-0.89|-0.12|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.12|-0.89|0.0113
71732567|NCT00110461|142980239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.67|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.67|-1.31|<0.0001
71732568|NCT00110461|142980239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.39|-0.72|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.72|-1.39|<0.0001
71732569|NCT00110461|142980240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.003|TWO_SIDED|95.0|-1.04|-0.22|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.22|-1.04|0.0030
71772491|NCT01227564|143044997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|173.16||||0.0161|TWO_SIDED|95.0|33.25|313.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||313.07|33.25|0.0161
71772492|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.652||||0.1807|TWO_SIDED|95.0|-6.57|1.267||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.267|-6.570|0.1807
71772493|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.497||||0.8051|TWO_SIDED|95.0|-3.515|4.508||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||4.508|-3.515|0.8051
71772494|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.078||||0.5331|TWO_SIDED|95.0|-4.519|2.364||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||2.364|-4.519|0.5331
71772495|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.9274|TWO_SIDED|95.0|-3.99|3.641||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||3.641|-3.990|0.9274
71659144|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.77|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.77|-0.49|0.669
71772496|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.549||||0.0743|TWO_SIDED|95.0|-0.36|7.458||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||7.458|-0.360|0.0743
71772497|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.687||||0.3163|TWO_SIDED|95.0|-1.656|5.031||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||5.031|-1.656|0.3163
71831548|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.21|TWO_SIDED|95.0|-1.43|6.46||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 8|||6.46|-1.43|0.210
71659145|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.89||||0.007|TWO_SIDED|95.0|0.24|1.53|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|0.24|0.007
71732570|NCT00110461|142980240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0001|TWO_SIDED|95.0|-1.18|-0.4|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.||-0.40|-1.18|0.0001
71732571|NCT00364533|142980259|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|91.4|||<|0.001||95.0|49.77|133.07|||ANCOVA|||The study was terminated and did not reach the planned sample size.||133.07|49.77|<0.001
71732572|NCT00364533|142980259|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|38.66|124.29|||ANCOVA|||The study was terminated and did not reach the planned sample size.||124.29|38.66|<0.001
71732573|NCT00364533|142980259|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|81.5|||<|0.001||95.0|39.21|123.8|||ANCOVA|||The study was terminated and did not reach the planned sample size.||123.80|39.21|<0.001
71732574|NCT00364533|142980259|SUPERIORITY_OR_OTHER||LS mean difference of SPID48|82.4|||<|0.001||95.0|38.96|125.88|||ANCOVA|||The study was terminated and did not reach the planned sample size.||125.88|38.96|<0.001
71732575|NCT01943552|142980273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|154.9|STANDARD_ERROR_OF_MEAN|32.32|<|0.0001|TWO_SIDED|95.0|91.08|218.63|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of FEV1 from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||218.63|91.08|<0.0001
71732576|NCT01943552|142980274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|51.0|STANDARD_ERROR_OF_MEAN|54.48||0.3509|TWO_SIDED|95.0|-56.55|158.46|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||158.46|-56.55|0.3509
71732577|NCT01943552|142980275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|2.18||0.2069|TWO_SIDED|95.0|-1.54|7.07|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||7.07|-1.54|0.2069
71732578|NCT01943552|142980276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1899|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for Oxygen saturation between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||0.93|-0.19|0.1899
71732579|NCT01943552|142980277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4758|TWO_SIDED|95.0|-0.72|1.55|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaCO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.||1.55|-0.72|0.4758
71732580|NCT01943552|142980278|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel Test Statistic|1.82||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||For main post-operative pulmonary complications, the Cochran-Mantel-Haenszel analysis was performed on the SCS. Mantel-Haenszel test with strata based on acute bronchodilator responsiveness at baseline and age was used to compare the number of patients with main post-operative pulmonary complications between the two arms.||||0.1779
71732581|NCT02855944|142980286|SUPERIORITY||Cox Proportional Hazard|0.639||||0.001|TWO_SIDED|95.0|0.489|0.835|||Regression, Cox|||||0.835|0.489|0.0010
71732582|NCT02855944|142980287|SUPERIORITY||Cox Proportional Hazard|0.665||||0.0017|TWO_SIDED|95.0|0.516|0.858|||Regression, Cox|||||0.858|0.516|0.0017
71732583|NCT02855944|142980290|SUPERIORITY||Cox Proportional Hazard|0.589||||0.0401|TWO_SIDED|95.0|0.356|0.976|||Regression, Cox|||||0.976|0.356|0.0401
71732584|NCT02855944|142980291|SUPERIORITY||Cox Proportional Hazard|0.564||||0.024|TWO_SIDED|95.0|0.343|0.927|||Regression, Cox|||||0.927|0.343|0.0240
71732585|NCT00576472|142980342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|-0.0452|-0.0208|||ANOVA|||||-0.0208|-0.0452|<.0001
71732586|NCT00576472|142980343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0285|STANDARD_ERROR_OF_MEAN|0.0046|<|0.0001|TWO_SIDED|95.0|0.019|0.038|||ANOVA|||||0.0380|0.0190|<.0001
71732587|NCT00576472|142980344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0144|STANDARD_ERROR_OF_MEAN|0.0064||0.025|TWO_SIDED|95.0|0.000204|0.0285|||ANOVA|||||0.0285|0.000204|0.025
71732588|NCT00576472|142980344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0442|STANDARD_ERROR_OF_MEAN|0.0093|<|0.0001|TWO_SIDED|95.0|0.0292|0.0591|||ANOVA|||||0.0591|0.0292|<.0001
71732589|NCT00576472|142980344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0491|STANDARD_ERROR_OF_MEAN|0.0064|<|0.0001|TWO_SIDED|95.0|0.0396|0.0586|||ANOVA|||||0.0586|0.0396|<.0001
71732590|NCT00576472|142980344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0298|STANDARD_ERROR_OF_MEAN|0.0083||0.0004|TWO_SIDED|95.0|0.00974|0.0499|||ANOVA|||||0.0499|0.00974|.0004
71732591|NCT00576472|142980344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0347|STANDARD_ERROR_OF_MEAN|0.0047|<|0.0001|TWO_SIDED|95.0|0.025|0.0445|||ANOVA|||||0.0445|0.0250|<.0001
71732592|NCT00576472|142980344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00494|STANDARD_ERROR_OF_MEAN|0.0083||0.552|TWO_SIDED|95.0|-0.00865|0.0185|||ANOVA|||||0.0185|-0.00865|.552
71732593|NCT00576472|142980345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.17|STANDARD_ERROR_OF_MEAN|1.93||0.0005|TWO_SIDED|95.0|-11.0|-3.3|||ANOVA|||||-3.3|-11.0|.0005
71732594|NCT00576472|142980346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34|STANDARD_ERROR_OF_MEAN|1.59||0.0413|TWO_SIDED|95.0|-6.5|-0.1|||ANOVA|||||-0.1|-6.5|0.0413
71772498|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.645||||0.519|TWO_SIDED|95.0|-6.721|3.43||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||3.430|-6.721|0.5190
71772499|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.758||||0.074|TWO_SIDED|95.0|-0.476|9.991||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||9.991|-0.476|0.0740
71772500|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.394||||0.4909|TWO_SIDED|95.0|-2.937|6.049||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||6.049|-2.937|0.4909
71772501|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.383||||0.9151|TWO_SIDED|95.0|-7.549|6.783||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||6.783|-7.549|0.9151
71831549|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.933|TWO_SIDED|95.0|-3.4|3.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 12|||3.12|-3.40|0.933
71831550|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.7||||0.091|TWO_SIDED|95.0|-0.43|5.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 18|||5.82|-0.43|0.091
71831551|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.69||||0.018|TWO_SIDED|95.0|0.82|8.56||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 26|||8.56|0.82|0.018
71831552|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.103|TWO_SIDED|95.0|-0.69|7.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 39|||7.29|-0.69|0.103
71831553|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.16||||0.448|TWO_SIDED|95.0|-3.5|7.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 52|||7.82|-3.50|0.448
71831554|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.089|TWO_SIDED|95.0|-0.27|3.77||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 2|||3.77|-0.27|0.089
71831555|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.095|TWO_SIDED|95.0|-0.31|3.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 4|||3.84|-0.31|0.095
71889147|NCT04666038|143299476|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7202|TWO_SIDED|95.0|0.679|1.749||The 2-sided p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||1.749|0.679|0.7202
71732595|NCT00576472|142980347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.74|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-11.0|-6.4|||ANOVA|||||-6.4|-11.0|<.0001
71831556|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.19||||0.073|TWO_SIDED|95.0|-0.2|4.58||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 8|||4.58|-0.20|0.073
71732596|NCT00576472|142980348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-12.0|-7.0|||ANOVA|||||-7.0|-12.0|<.0001
71732597|NCT00576472|142980349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|4.4|11.6|||ANOVA|||||11.6|4.4|<.0001
71732598|NCT00576472|142980350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.03||0.8425|TWO_SIDED|95.0|-2.3|1.9|||ANOVA|||||1.9|-2.3|.8425
71732599|NCT00576472|142980351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.73||0.0016|TWO_SIDED|95.0|-3.9|-0.9|||ANOVA|||||-0.9|-3.9|.0016
71732600|NCT00576472|142980352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|1.04||0.8329|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|||||2.3|-1.9|.8329
71732601|NCT00576472|142980354|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||t-test, 2 sided|||||||0.0077
71732602|NCT00576472|142980354|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71732603|NCT00576472|142980354|SUPERIORITY_OR_OTHER|||||||0.1408||95.0|||||t-test, 2 sided|||||||0.1408
71732604|NCT00576472|142980355|SUPERIORITY_OR_OTHER|||||||0.0428||95.0|||||t-test, 2 sided|||||||0.0428
71732605|NCT00576472|142980355|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||t-test, 2 sided|||||||0.0058
71732606|NCT00576472|142980355|SUPERIORITY_OR_OTHER|||||||0.4258||95.0|||||t-test, 2 sided|||||||0.4258
71732607|NCT00576472|142980356|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
71732608|NCT00576472|142980356|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71732609|NCT00576472|142980356|SUPERIORITY_OR_OTHER|||||||0.4086||95.0|||||t-test, 2 sided|||||||0.4086
71732610|NCT00576472|142980357|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||t-test, 2 sided|||||||0.0001
71732611|NCT00576472|142980357|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||t-test, 2 sided|||||||0.0007
71732612|NCT00576472|142980357|SUPERIORITY_OR_OTHER|||||||0.7007||95.0|||||t-test, 2 sided|||||||0.7007
71732613|NCT00576472|142980358|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71732614|NCT00576472|142980358|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||t-test, 2 sided|||||||0.0016
71732615|NCT00576472|142980358|SUPERIORITY_OR_OTHER|||||||0.6237||95.0|||||t-test, 2 sided|||||||0.6237
71732616|NCT00576472|142980359|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71732617|NCT00576472|142980359|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<.0001
71732618|NCT00576472|142980359|SUPERIORITY_OR_OTHER|||||||0.6071||95.0|||||t-test, 2 sided|||||||0.6071
71732619|NCT00576472|142980360|SUPERIORITY_OR_OTHER|||||||0.1386||95.0|||||t-test, 2 sided|||||||0.1386
71732620|NCT00576472|142980360|SUPERIORITY_OR_OTHER|||||||0.0905||95.0|||||t-test, 2 sided|||||||0.0905
71732621|NCT00576472|142980360|SUPERIORITY_OR_OTHER|||||||0.8039||95.0|||||t-test, 2 sided|||||||0.8039
71732622|NCT00576472|142980361|SUPERIORITY_OR_OTHER|||||||0.7496||95.0|||||t-test, 2 sided|||||||0.7496
71732623|NCT00576472|142980361|SUPERIORITY_OR_OTHER|||||||0.9489||95.0|||||t-test, 2 sided|||||||0.9489
71732624|NCT00576472|142980361|SUPERIORITY_OR_OTHER|||||||0.7021||95.0|||||t-test, 2 sided|||||||0.7021
71732625|NCT00576472|142980362|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|||||||0.0190
71732626|NCT00576472|142980362|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71732627|NCT00576472|142980362|SUPERIORITY_OR_OTHER|||||||0.1622||95.0|||||t-test, 2 sided|||||||0.1622
71732628|NCT00576472|142980363|SUPERIORITY_OR_OTHER|||||||0.1202||95.0|||||t-test, 2 sided|||||||0.1202
71732629|NCT00576472|142980363|SUPERIORITY_OR_OTHER|||||||0.0103||95.0|||||t-test, 2 sided|||||||0.0103
71732630|NCT00576472|142980363|SUPERIORITY_OR_OTHER|||||||0.2831||95.0|||||t-test, 2 sided|||||||0.2831
71732631|NCT00576472|142980364|SUPERIORITY_OR_OTHER|||||||0.7027||95.0|||||t-test, 2 sided|||||||0.7027
71732632|NCT00576472|142980365|SUPERIORITY_OR_OTHER|||||||0.7493||95.0|||||t-test, 2 sided|||||||0.7493
71732633|NCT00576472|142980366|SUPERIORITY_OR_OTHER|||||||0.7339||95.0|||||t-test, 2 sided|||||||0.7339
71732634|NCT00576472|142980367|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||t-test, 2 sided|||||||0.6148
71732635|NCT00576472|142980368|SUPERIORITY_OR_OTHER|||||||0.4456||95.0|||||t-test, 2 sided|||||||0.4456
71732636|NCT00576472|142980369|SUPERIORITY_OR_OTHER|||||||0.5866||95.0|||||t-test, 2 sided|||||||0.5866
71732637|NCT00576472|142980370|SUPERIORITY_OR_OTHER|||||||0.8918||95.0|||||t-test, 2 sided|||||||0.8918
71732638|NCT00576472|142980371|SUPERIORITY_OR_OTHER|||||||0.4427||95.0|||||t-test, 2 sided|||||||0.4427
71732639|NCT00576472|142980372|SUPERIORITY_OR_OTHER|||||||0.4203||95.0|||||t-test, 2 sided|||||||0.4203
71732640|NCT00576472|142980373|SUPERIORITY_OR_OTHER|||||||0.5754||95.0|||||t-test, 2 sided|||||||0.5754
71732641|NCT00576472|142980374|SUPERIORITY_OR_OTHER|||||||0.0251||95.0|||||t-test, 2 sided|||||||0.0251
71732642|NCT00576472|142980375|SUPERIORITY_OR_OTHER|||||||0.1049||95.0|||||t-test, 2 sided|||||||0.1049
71732643|NCT03263780|142980377|SUPERIORITY||Sensitivity|0.25||||0.056|TWO_SIDED|95.0|0.19|0.46||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 6+)||0.46|0.19|0.056
71732644|NCT03263780|142980377|SUPERIORITY||Sensitivity|0.56||||0.56|TWO_SIDED|95.0|0.44|0.78||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 6+)||0.78|0.44|0.56
71732645|NCT03263780|142980377|SUPERIORITY||Sensitivity|0.22||||0.06|TWO_SIDED|95.0|0.17|0.47||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 6+)||0.47|0.17|0.060
71732646|NCT03263780|142980377|SUPERIORITY||Sensitivity|0.5||||0.083|TWO_SIDED|95.0|0.39|0.74||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 6+)||0.74|0.39|0.083
71732647|NCT03263780|142980378|SUPERIORITY||Sensitivity|0.35||||0.096|TWO_SIDED|95.0|0.26|0.65||mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 3-5 \& Gleason 7+)||0.65|0.26|0.096
71732648|NCT03263780|142980378|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 3-5 \& Gleason 7+)||0.90|0.46|0.317
71659146|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.71|2.52|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.52|0.71|<0.001
71659147|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.063|TWO_SIDED|95.0|-0.05|1.78|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.78|-0.05|0.063
71659148|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.75||||0.022|TWO_SIDED|95.0|0.11|1.39|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|0.11|0.022
71659149|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.008|TWO_SIDED|95.0|0.32|2.12|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.12|0.32|0.008
71659150|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.876|TWO_SIDED|95.0|-0.58|0.68|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.68|-0.58|0.876
71732649|NCT03263780|142980378|SUPERIORITY||Sensitivity|0.3||||0.063|TWO_SIDED|95.0|0.23|0.66||mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI and PET (PIRADS 4-5 \& Gleason 7+)||0.66|0.23|0.063
71732650|NCT03263780|142980378|SUPERIORITY||Sensitivity|0.6||||0.317|TWO_SIDED|95.0|0.46|0.9||mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)|Durkalski's Chi-square test||We did not present standard deviation as the variability is already incorporated in the provided confidence interval.|mpMRI vs hrMRI or PET (PIRADS 4-5 \& Gleason 7+)||0.90|0.46|0.317
71732651|NCT00903331|142980385|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.9631|TWO_SIDED|95.0|-0.09|0.08|||Wilcoxon Rank Sum|||The null hypothesis was that there was no difference between ACT-064922 and placebo for the change in FVC from baseline to the end of Period 1. The aim was to detect a placebo-corrected change in FVC of ≥ 0.1 L (Standard Deviation = 0.2 L) at a two-sided 0.05 type 1 error level and 80% power.||0.08|-0.09|0.9631
71772502|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.394||||0.1533|TWO_SIDED|95.0|-2.069|12.857||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||12.857|-2.069|0.1533
71772503|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.4371|TWO_SIDED|95.0|-3.904|8.915||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||8.915|-3.904|0.4371
71772504|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.6167|TWO_SIDED|95.0|-10.999|6.579||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.579|-10.999|0.6167
71772505|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.11||||0.1844|TWO_SIDED|95.0|-2.993|15.212||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||15.212|-2.993|0.1844
71772506|NCT01227564|143044998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95||||0.6205|TWO_SIDED|95.0|-5.888|9.878||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.878|-5.888|0.6205
71772507|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.418||||0.1695|TWO_SIDED|95.0|-0.183|1.018||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||1.018|-0.183|0.1695
71831557|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.853|TWO_SIDED|95.0|-2.08|2.51||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 12|||2.51|-2.08|0.853
71831558|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.334|TWO_SIDED|95.0|-1.43|4.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 18|||4.17|-1.43|0.334
71659151|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49||||0.134|TWO_SIDED|95.0|-0.15|1.13|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.13|-0.15|0.134
71732652|NCT00903331|142980386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.118||||0.7056|TWO_SIDED|95.0|0.626|1.996|||Log Rank|||||1.996|0.626|0.7056
71732653|NCT00257660|142980408|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.84|||<|0.0001|TWO_SIDED|95.0|-12.94|-4.74||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.74|-12.94|<0.0001
71732654|NCT00257660|142980409|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.81|||<|0.0001||95.0|-12.91|-4.71||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-4.71|-12.91|<0.0001
71732655|NCT00257660|142980410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.12||||0.019||95.0|-7.55|-0.68||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."|||-0.68|-7.55|0.019
71732656|NCT00257660|142980411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.2|||<|0.001||95.0|-24.0|-6.4||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.4|-24.0|<0.001
71732657|NCT00257660|142980412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.2|||<|0.001||95.0|-22.3|-6.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-6.1|-22.3|<0.001
71732658|NCT00257660|142980413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.95|||<|0.001||95.0|-25.8|-8.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-8.1|-25.8|<0.001
71831559|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.33||||0.017|TWO_SIDED|95.0|0.61|6.05||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 26|||6.05|0.61|0.017
71659152|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.011|TWO_SIDED|95.0|0.27|2.07|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.07|0.27|0.011
71732659|NCT00257660|142980414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.0|||<|0.001||95.0|-24.2|-7.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-7.8|-24.2|<0.001
71732660|NCT00257660|142980415|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.05||||0.007||95.0|-19.0|-3.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-3.1|-19.0|0.007
71772508|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147||||0.6331|TWO_SIDED|95.0|-0.465|0.759||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.759|-0.465|0.6331
71732661|NCT00257660|142980416|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.05||||0.028||95.0|-13.3|-0.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||-0.8|-13.3|0.028
71732662|NCT00257660|142980417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.65||||0.061||95.0|-0.17|7.47||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.47|-0.17|0.061
71732663|NCT00257660|142980418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.66||||0.002||95.0|1.73|7.58||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)|||7.58|1.73|0.002
71732664|NCT00257660|142980419|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.206|||<|0.0001||95.0|3.01|17.26||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\<0.05 was considered significant.|odds ratio|The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country||The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.||17.26|3.01|<0.0001
71732665|NCT03907033|142980425|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Hydrocodone use||||1.000
71732666|NCT03907033|142980425|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Oxycodone use||||0.010
71732667|NCT03907033|142980426|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Ibuprofen use||||0.248
71732668|NCT03907033|142980426|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm for Tylenol use||||1.000
71732669|NCT03907033|142980428|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 24 hours post-surgery||||0.846
71732670|NCT03907033|142980428|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 48 hours post-surgery||||0.490
71732671|NCT03907033|142980428|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm 72 hours post-surgery||||0.564
71732672|NCT03907033|142980429|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 24 hours post-surgery||||0.264
71732673|NCT03907033|142980429|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 48 hours post-surgery||||0.970
71732674|NCT03907033|142980429|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine arm at 72 hours post-surgery||||0.536
71732675|NCT03907033|142980430|SUPERIORITY|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 24 hours post-surgery||||0.957
71732676|NCT03907033|142980430|SUPERIORITY|||||||0.353|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 48 hours post-surgery||||0.353
71732677|NCT03907033|142980430|SUPERIORITY|||||||0.165|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.165
71732678|NCT03907033|142980432|SUPERIORITY|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 72 hours post-surgery||||0.802
71732679|NCT03907033|142980432|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||Standard Bupivacaine study arm compared to Liposomal Bupivacaine study arm at 7-10 days post-surgery||||0.656
71732680|NCT01174173|142980434|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||A two-sided t-test was performed with p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.0013
71732681|NCT01174173|142980435|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||A two-sided t-test was performed for change in 6-minute walk test and p-value \< 0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.09
71732682|NCT01174173|142980436|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of \<0.05 was considered statistically significant a priori.|t-test, 2 sided|||||||0.37
71732683|NCT01174173|142980438|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
71732684|NCT01174173|142980439|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71732685|NCT03938324|142980446|SUPERIORITY|||||||0.0034||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.0034
71831560|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13||||0.077|TWO_SIDED|95.0|-0.34|6.59||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 39|||6.59|-0.34|0.077
71732686|NCT03938324|142980447|SUPERIORITY|||||||0.5137||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.5137
71732687|NCT03938324|142980448|SUPERIORITY|||||||0.4107||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.4107
71831561|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.34||||0.355|TWO_SIDED|95.0|-2.7|7.38||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 52|||7.38|-2.70|0.355
71831562|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.82||||0.044|TWO_SIDED|95.0|0.08|5.55||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 2|||5.55|0.08|0.044
71831563|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.87||||0.032|TWO_SIDED|95.0|0.25|5.49||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 4|||5.49|0.25|0.032
71831564|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.025|TWO_SIDED|95.0|0.49|7.01||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 8|||7.01|0.49|0.025
71831565|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.785|TWO_SIDED|95.0|-2.5|3.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 12|||3.29|-2.50|0.785
71831566|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34||||0.052|TWO_SIDED|95.0|-0.03|6.7||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 18|||6.70|-0.03|0.052
71831567|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53||||0.041|TWO_SIDED|95.0|0.14|6.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 26|||6.92|0.14|0.041
71831568|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19||||0.043|TWO_SIDED|95.0|0.13|8.25||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 39|||8.25|0.13|0.043
71831569|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.67||||0.562|TWO_SIDED|95.0|-6.58|11.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 52|||11.92|-6.58|0.562
71772509|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.2907|TWO_SIDED|95.0|-0.247|0.812||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.812|-0.247|0.2907
71772510|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007||||0.9846|TWO_SIDED|95.0|-0.675|0.688||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.688|-0.675|0.9846
71831570|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.746|TWO_SIDED|95.0|-1.09|1.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 2|||1.52|-1.09|0.746
71831571|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.878|TWO_SIDED|95.0|-1.53|1.79||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 4|||1.79|-1.53|0.878
71831572|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35||||0.644|TWO_SIDED|95.0|-1.15|1.85||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 8|||1.85|-1.15|0.644
71831573|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.715|TWO_SIDED|95.0|-1.86|1.28||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 12|||1.28|-1.86|0.715
71831574|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.803|TWO_SIDED|95.0|-1.62|2.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 18|||2.10|-1.62|0.803
71831575|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.184|TWO_SIDED|95.0|-0.63|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 26|||3.27|-0.63|0.184
71831576|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05||||0.102|TWO_SIDED|95.0|-0.42|4.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 39|||4.52|-0.42|0.102
71831577|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44||||0.383|TWO_SIDED|95.0|-1.85|4.73||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 52|||4.73|-1.85|0.383
71831578|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.607|TWO_SIDED|95.0|-1.2|2.06||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 2|||2.06|-1.20|0.607
71831579|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.348|TWO_SIDED|95.0|-0.74|2.08||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 4|||2.08|-0.74|0.348
71831580|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.826|TWO_SIDED|95.0|-1.32|1.65||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 8|||1.65|-1.32|0.826
71831581|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.588|TWO_SIDED|95.0|-2.13|1.21||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 12|||1.21|-2.13|0.588
71831582|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.585|TWO_SIDED|95.0|-1.08|1.91||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 18|||1.91|-1.08|0.585
71889148|NCT04666038|143299477|SUPERIORITY||Hazard Ratio (HR)|0.365|||<|0.0001|TWO_SIDED|95.0|0.254|0.524||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.524|0.254|<0.0001
71889149|NCT04666038|143299478|SUPERIORITY||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.28|0.534||The 2-sided nominal p-value was calculated based on a stratified log-rank test.|Log Rank||The HR and 95% CI were estimated from a stratified Cox proportional hazards model.|||0.534|0.280|<0.0001
71772511|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.304||||0.3845|TWO_SIDED|95.0|-1.0|0.392||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.392|-1.000|0.3845
71732688|NCT03938324|142980449|SUPERIORITY|||||||0.1708||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.1708
71772512|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149||||0.6204|TWO_SIDED|95.0|-0.748|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.450|-0.748|0.6204
71831583|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.82||||0.231|TWO_SIDED|95.0|-2.48|10.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 26|||10.12|-2.48|0.231
71831584|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.45||||0.24|TWO_SIDED|95.0|-0.99|3.89||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 39|||3.89|-0.99|0.240
71831585|NCT02299375|143167542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.517|TWO_SIDED|95.0|-2.49|4.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 52|||4.84|-2.49|0.517
71831586|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.706|TWO_SIDED|95.0|-4.2|2.85||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 12|||2.85|-4.20|0.706
71831587|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.694|TWO_SIDED|95.0|-3.58|5.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 26|||5.36|-3.58|0.694
71831588|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.83||||0.382|TWO_SIDED|95.0|-9.23|3.58||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 39|||3.58|-9.23|0.382
71831589|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.903|TWO_SIDED|95.0|-8.54|7.57||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 52|||7.57|-8.54|0.903
71831590|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.481|TWO_SIDED|95.0|-6.33|2.99||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 12|||2.99|-6.33|0.481
71831591|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.793|TWO_SIDED|95.0|-4.79|6.25||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 26|||6.25|-4.79|0.793
71831592|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6||||0.421|TWO_SIDED|95.0|-12.45|5.26||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 39|||5.26|-12.45|0.421
71831593|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.98||||0.162|TWO_SIDED|95.0|-19.35|3.4||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 52|||3.40|-19.35|0.162
71831594|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.592|TWO_SIDED|95.0|-3.31|5.78||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 12|||5.78|-3.31|0.592
71831595|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03||||0.704|TWO_SIDED|95.0|-4.31|6.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 26|||6.36|-4.31|0.704
71659153|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.112|TWO_SIDED|95.0|-0.17|1.64|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.64|-0.17|0.112
71772513|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014||||0.981|TWO_SIDED|95.0|-1.221|1.192||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||1.192|-1.221|0.9810
71772514|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.796||||0.2034|TWO_SIDED|95.0|-2.034|0.443||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.443|-2.034|0.2034
71772515|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.405||||0.4491|TWO_SIDED|95.0|-1.469|0.659||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.659|-1.469|0.4491
71772516|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255||||0.8074|TWO_SIDED|95.0|-1.827|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||2.337|-1.827|0.8074
71831596|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.546|TWO_SIDED|95.0|-10.32|5.5||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 39|||5.50|-10.32|0.546
71831597|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39||||0.35|TWO_SIDED|95.0|-5.06|13.84||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 52|||13.84|-5.06|0.350
71831598|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.411|TWO_SIDED|95.0|-5.75|2.37||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 12|||2.37|-5.75|0.411
71831599|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.896|TWO_SIDED|95.0|-5.67|4.97||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 26|||4.97|-5.67|0.896
71831600|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.21||||0.559|TWO_SIDED|95.0|-9.73|5.3||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 39|||5.30|-9.73|0.559
71659154|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.179|TWO_SIDED|95.0|-0.2|1.08|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.08|-0.20|0.179
71659155|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97||||0.032|TWO_SIDED|95.0|0.09|1.85|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.85|0.09|0.032
71831601|NCT02299375|143167549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.809|TWO_SIDED|95.0|-12.19|9.6||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 52|||9.60|-12.19|0.809
71831602|NCT00704184|143167561|SUPERIORITY_OR_OTHER||Adjusted difference in %|69.3|||<|0.001|TWO_SIDED|95.0|40.3|86.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||86.7|40.3|<0.001
71831603|NCT00704184|143167561|SUPERIORITY_OR_OTHER||Adjusted difference in %|73.6|||<|0.001|TWO_SIDED|95.0|46.0|88.6|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||88.6|46.0|<0.001
71659156|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.85|TWO_SIDED|95.0|-0.56|0.67|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.67|-0.56|0.850
71732689|NCT03938324|142980450|SUPERIORITY|||||||0.7982||||||The two-tailed significance set at 0.05 was not adjusted for multiple outcomes or comparisons. No adjustments for pairwise comparisons were required for the model.|Multi-level mixed effects|Fixed effects were treatment, time, treatment-by time; whereas, random effects were participant and participant-by-time.||Multi-level mixed effects model for longitudinal data to compare treatment group difference in trajectory across 12 months. Group sizes provided at least 80% power to detect a true difference in change trajectories (treatment-by-time interaction effect), assuming a medium effect size, two-tailed tests, and statistical significance set at 0.05. Null hypothesis was no treatment group difference in the trajectory from baseline to 12 months (no significant treatment-by-time effect).||||0.7982
71732690|NCT02408523|142980477|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.001|TWO_SIDED|95.0|0.377|0.774||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.774|0.377|<0.001
71772517|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.029||||0.3444|TWO_SIDED|95.0|-3.189|1.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.131|-3.189|0.3444
71772518|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387||||0.6772|TWO_SIDED|95.0|-2.239|1.464||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||1.464|-2.239|0.6772
71772519|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.652||||0.6325|TWO_SIDED|95.0|-2.063|3.367||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.367|-2.063|0.6325
71772520|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.5706|TWO_SIDED|95.0|-3.606|2.007||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.007|-3.606|0.5706
71772521|NCT01227564|143044999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.074||||0.9513|TWO_SIDED|95.0|-2.485|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.337|-2.485|0.9513
71772522|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.6054|TWO_SIDED|95.0|-0.074|0.043||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.043|-0.074|0.6054
71831604|NCT00704184|143167561|SUPERIORITY_OR_OTHER||Adjusted difference in %|63.3|||<|0.001|TWO_SIDED|95.0|32.8|82.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).|||82.7|32.8|<0.001
71831605|NCT00704184|143167561|SUPERIORITY_OR_OTHER||Adjusted difference in %|77.8|||<|0.001|TWO_SIDED|95.0|49.2|91.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).|||91.3|49.2|<0.001
71831606|NCT00704184|143167564|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
71889150|NCT03400800|143299482|SUPERIORITY||Mean Difference (Final Values)|-53.5|||<|0.0001|TWO_SIDED|95.0|-56.66|-50.35||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-50.35|-56.66|<0.0001
71831607|NCT00704184|143167564|SUPERIORITY_OR_OTHER||Adjusted difference|10.8|||||TWO_SIDED|95.0|-7.6|33.2|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.2|-7.6|
71659157|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.311|TWO_SIDED|95.0|-0.3|0.95|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.95|-0.30|0.311
71732691|NCT02408523|142980478|SUPERIORITY||KM seizure free of LCM vs Placebo|14.1|||=|0.011|TWO_SIDED|95.0|3.2|25.1||Superiority of LCM vs Placebo p-value was based on a chi-square test on 1 degree of freedom.|Mantel Haenszel||Stratified difference in proportion of subjects who are seizure-free from PGTCS on Lacosamide (FAS) vs Placebo (FAS).|The key secondary efficacy variable was evaluated using an extended Mantel-Haenszel testing procedure. Baseline PGTCS Frequency from Combined Baseline and development (age from interactive response technology (IRT)) were calculated from IRT.||25.1|3.2|=0.011
71732692|NCT02408523|142980479|SUPERIORITY||Hazard Ratio (HR)|0.683|||=|0.012|TWO_SIDED|95.0|0.507|0.921||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants' Baseline PGTCS frequency and Development from interactive response technology (IRT) (\<= 2 per 28 days in the Combined Baseline Period and Pediatric, \<= 2 per 28 days in the Combined Baseline Period and Adult, and \> 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.||0.921|0.507|=0.012
71732693|NCT05063539|142980482|SUPERIORITY||Posterior Mean Difference|1.68|||||TWO_SIDED|95.0|-0.375|3.771|||||Posterior mean difference with 95% credible interval is reported.|||3.771|-0.375|
71732694|NCT05063539|142980482|SUPERIORITY||Posterior Mean Difference|-3.2|||||TWO_SIDED|95.0|-5.354|-1.042|||||Posterior mean difference with 95% credible interval is reported.|||-1.042|-5.354|
71732695|NCT05063539|142980483|SUPERIORITY||Posterior Mean Difference|1.59|||||TWO_SIDED|95.0|-0.443|3.697|||||Posterior mean difference with 95% credible interval is reported.|||3.697|-0.443|
71732696|NCT05063539|142980483|SUPERIORITY||Posterior Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.277|-2.862||||||||-2.862|-7.277|
71732697|NCT05063539|142980484|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.32||0.665|TWO_SIDED|95.0|-0.763|0.488|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.488|-0.763|0.665
71732698|NCT05063539|142980484|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.33||0.001|TWO_SIDED|95.0|0.435|1.736|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.736|0.435|0.001
71732699|NCT05063539|142980485|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.35||0.878|TWO_SIDED|95.0|-0.641|0.749|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.749|-0.641|0.878
71732700|NCT05063539|142980485|SUPERIORITY||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.615|2.05|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.050|0.615|<0.001
71732701|NCT05063539|142980486|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.99||0.252|TWO_SIDED|95.0|-3.073|0.811|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.811|-3.073|0.252
71772523|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4087|TWO_SIDED|95.0|-0.035|0.084||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.084|-0.035|0.4087
71772524|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8518|TWO_SIDED|95.0|-0.046|0.056||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.056|-0.046|0.8518
71831608|NCT00704184|143167564|SUPERIORITY_OR_OTHER||Adjusted difference|11.2|||||TWO_SIDED|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||33.8|-9.7|
71732702|NCT05063539|142980486|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.03||0.825|TWO_SIDED|95.0|-2.252|1.797|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.797|-2.252|0.825
71732703|NCT05063539|142980487|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.09||0.733|TWO_SIDED|95.0|-2.527|1.779|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.779|-2.527|0.733
71732704|NCT05063539|142980487|SUPERIORITY||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.13||0.143|TWO_SIDED|95.0|-0.565|3.877|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||3.877|-0.565|0.143
71732705|NCT05063539|142980488|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.0||0.86|TWO_SIDED|95.0|-1.802|2.158|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||2.158|-1.802|0.860
71732706|NCT05063539|142980488|SUPERIORITY||LS Mean Difference|-2.51|STANDARD_ERROR_OF_MEAN|1.04||0.017|TWO_SIDED|95.0|-4.567|-0.456|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.456|-4.567|0.017
71732707|NCT05063539|142980489|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.1||0.479|TWO_SIDED|95.0|-2.949|1.387|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.387|-2.949|0.479
71732708|NCT05063539|142980489|SUPERIORITY||LS Mean Difference|-4.01|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-6.239|-1.788|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-1.788|-6.239|<0.001
71732709|NCT05063539|142980490|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.53||0.259|TWO_SIDED|95.0|-0.445|1.642|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.642|-0.445|0.259
71732710|NCT05063539|142980490|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.55||0.324|TWO_SIDED|95.0|-1.629|0.541|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||0.541|-1.629|0.324
71732711|NCT05063539|142980491|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.57||0.749|TWO_SIDED|95.0|-0.946|1.313|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||1.313|-0.946|0.749
71659158|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.043|TWO_SIDED|95.0|0.03|1.79|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.79|0.03|0.043
71659159|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.154||95.0|-0.24|1.53|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.53|-0.24|0.154
71659160|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.408|TWO_SIDED|95.0|-0.36|0.89|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.89|-0.36|0.408
71732712|NCT05063539|142980491|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.59||0.029|TWO_SIDED|95.0|-2.462|-0.134|||NCS2|A NCS model with 2 degrees of freedom (NCS2) was used.||||-0.134|-2.462|0.029
71772525|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025||||0.4216|TWO_SIDED|95.0|-0.085|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.036|-0.085|0.4216
71732713|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.012||0.346|TWO_SIDED|95.0|-0.01|0.03|||ANCOVA|||Frontal||0.03|-0.01|0.346
71732714|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.412|TWO_SIDED|95.0|-0.04|0.01|||ANCOVA|||Frontal||0.01|-0.04|0.412
71732715|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Parietal||0.02|-0.04|0.421
71732716|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.014||0.08|TWO_SIDED|95.0|-0.05|0.0|||ANCOVA|||Parietal||0.00|-0.05|0.080
71772526|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.273|TWO_SIDED|95.0|-0.028|0.097||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.097|-0.028|0.2730
71772527|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.8549|TWO_SIDED|95.0|-0.048|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.058|-0.048|0.8549
71772528|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.5847|TWO_SIDED|95.0|-0.12|0.068||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.068|-0.120|0.5847
71659161|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.065|TWO_SIDED|95.0|-0.05|1.68|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.68|-0.05|0.065
71732717|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.021||0.192|TWO_SIDED|95.0|-0.07|0.01|||ANCOVA|||Lateral occipital||0.01|-0.07|0.192
71659162|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.862|TWO_SIDED|95.0|-0.66|0.55|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.55|-0.66|0.862
71831609|NCT00704184|143167564|SUPERIORITY_OR_OTHER||Adjusted difference|5.4|||||TWO_SIDED|95.0|-16.5|28.4|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).|||28.4|-16.5|
71659163|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.352|TWO_SIDED|95.0|-0.32|0.9|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.90|-0.32|0.352
71732718|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.279|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||Lateral occipital||0.02|-0.07|0.279
71732719|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.016||0.693|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||Lateral temporal||0.02|-0.04|0.693
71732720|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.04|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA|||Lateral temporal||-0.00|-0.07|0.040
71732721|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.838|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.03|-0.03|0.838
71732722|NCT05063539|142980492|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.016||0.055|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.00|-0.06|0.055
71772529|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067||||0.174|TWO_SIDED|95.0|-0.03|0.163||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.163|-0.030|0.1740
71772530|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.6255|TWO_SIDED|95.0|-0.063|0.103||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.103|-0.063|0.6255
71772531|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.7658|TWO_SIDED|95.0|-0.177|0.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.131|-0.177|0.7658
71772532|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.3309|TWO_SIDED|95.0|-0.082|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.240|-0.082|0.3309
71772533|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.6872|TWO_SIDED|95.0|-0.11|0.166||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.166|-0.110|0.6872
71772534|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.9752|TWO_SIDED|95.0|-0.196|0.202||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.202|-0.196|0.9752
71772535|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143||||0.1715|TWO_SIDED|95.0|-0.064|0.349||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.349|-0.064|0.1715
71772536|NCT01227564|143045000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.4145|TWO_SIDED|95.0|-0.105|0.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.250|-0.105|0.4145
71772537|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011||||0.5134|TWO_SIDED|95.0|-0.043|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.022|-0.043|0.5134
71831610|NCT00704184|143167565|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
71831611|NCT00704184|143167565|SUPERIORITY_OR_OTHER||Adjusted difference|16.2|||||TWO_SIDED|95.0|-2.2|39.5|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||39.5|-2.2|
71831612|NCT00704184|143167565|SUPERIORITY_OR_OTHER||Adjusted difference|16.9|||||TWO_SIDED|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||40.2|-4.0|
71831613|NCT00704184|143167565|SUPERIORITY_OR_OTHER||Adjusted difference|10.7|||||TWO_SIDED|95.0|-11.4|34.6|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).|||34.6|-11.4|
71831614|NCT00704184|143167566|SUPERIORITY_OR_OTHER||Difference in Least Squares (LC) Means|-2.5|||||TWO_SIDED|95.0|-3.2|-1.8|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-1.8|-3.2|
71831615|NCT00704184|143167566|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
71831616|NCT00704184|143167566|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.4|
71889151|NCT03400800|143299483|SUPERIORITY||Mean Difference (Final Values)|-49.17|||<|0.0001|TWO_SIDED|95.0|-51.57|-46.77||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.77|-51.57|<0.0001
71889152|NCT03400800|143299484|SUPERIORITY||Median Difference (Final Values)|-51.87|||<|0.0001|TWO_SIDED|95.0|-55.01|-48.72||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-48.72|-55.01|<.0001
71732723|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.455|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Frontal||0.04|-0.02|0.455
71732724|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.745|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA|||Frontal||0.02|-0.03|0.745
71732725|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.015||0.676|TWO_SIDED|95.0|-0.02|0.04|||ANCOVA|||Parietal||0.04|-0.02|0.676
71732726|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.794|TWO_SIDED|95.0|-0.03|0.03|||ANCOVA|||Parietal||0.03|-0.03|0.794
71732727|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.643|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Lateral occipital||0.03|-0.05|0.643
71732728|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.021||0.88|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Lateral occipital||0.04|-0.05|0.880
71732729|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.844|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Lateral temporal||0.03|-0.04|0.844
71732730|NCT05063539|142980493|SUPERIORITY|Lateral temporal|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.388|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.388
71732731|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.016||0.815|TWO_SIDED|95.0|-0.03|0.04|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.04|-0.03|0.815
71732732|NCT05063539|142980493|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.017||0.562|TWO_SIDED|95.0|-0.04|0.02|||ANCOVA|||AD neocortical signature (measured using MUBADA)||0.02|-0.04|0.562
71732733|NCT05063539|142980494|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.024|<|0.001|TWO_SIDED|95.0|0.04|0.14|||Mixed Models Analysis|||Bilateral Hippocampus||0.14|0.04|<0.001
71732734|NCT05063539|142980494|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||Bilateral Hippocampus||0.18|0.08|<0.001
71732735|NCT05063539|142980494|SUPERIORITY||LS Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-3.53|-1.21|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.21|-3.53|<0.001
71732736|NCT05063539|142980494|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.611||0.008|TWO_SIDED|95.0|-2.84|-0.43|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.43|-2.84|0.008
71732737|NCT05063539|142980494|SUPERIORITY||LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|1.715|<|0.001|TWO_SIDED|95.0|4.79|11.56|||Mixed Models Analysis|||Bilateral Whole Brain||11.56|4.79|<0.001
71732738|NCT05063539|142980494|SUPERIORITY||LS Mean Difference|9.37|STANDARD_ERROR_OF_MEAN|1.804|<|0.001|TWO_SIDED|95.0|5.81|12.92|||Mixed Models Analysis|||Bilateral Whole Brain||12.92|5.81|<0.001
71732739|NCT05063539|142980495|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.04|0.13|||Mixed Models Analysis|||Bilateral Hippocampus||0.13|0.04|<0.001
71831617|NCT00704184|143167566|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7|||||TWO_SIDED|95.0|-3.3|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.|||-2.0|-3.3|
71831618|NCT03473340|143167612|SUPERIORITY|||||||0.17697507|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.17697507
71889153|NCT03400800|143299485|SUPERIORITY||Mean Difference (Final Values)|-48.94|||<|0.0001|TWO_SIDED|95.0|-51.39|-46.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-46.48|-51.39|<0.0001
71889154|NCT03400800|143299486|SUPERIORITY||Mean Difference (Final Values)|-79.27|||<|0.0001|TWO_SIDED|95.0|-81.97|-76.57||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-76.57|-81.97|<0.0001
71889155|NCT03400800|143299487|SUPERIORITY||Mean Difference (Final Values)|-29.79|||<|0.0001|TWO_SIDED|95.0|-31.78|-27.81||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-27.81|-31.78|<0.0001
71732740|NCT05063539|142980495|SUPERIORITY|Bilateral Hippocampus|LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.023|<|0.001|TWO_SIDED|95.0|0.08|0.17|||Mixed Models Analysis|||||0.17|0.08|<0.001
71732741|NCT05063539|142980495|SUPERIORITY||LS Mean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.33|-1.08|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-1.08|-3.33|<0.001
71732742|NCT05063539|142980495|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.582||0.015|TWO_SIDED|95.0|-2.57|-0.28|||Mixed Models Analysis|||Bilateral Whole Lateral Ventricles||-0.28|-2.57|0.015
71732743|NCT05063539|142980495|SUPERIORITY||LS Mean Difference|7.17|STANDARD_ERROR_OF_MEAN|1.635|<|0.001|TWO_SIDED|95.0|3.95|10.4|||Mixed Models Analysis|||Bilateral Whole Brain||10.40|3.95|<0.001
71732744|NCT05063539|142980495|SUPERIORITY||LS Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|4.85|11.47|||Mixed Models Analysis|||Bilateral Whole Brain||11.47|4.85|<0.001
71732745|NCT04428151|142980519|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.9963|TWO_SIDED|95.0|1.11|1.97||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.97|1.11|0.9963
71732746|NCT04428151|142980520|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4181|TWO_SIDED|95.0|0.74|1.28||One-sided p-value based on log-rank test stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1). The reported p-value is nominal.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||1.28|0.74|0.4181
71732747|NCT04428151|142980521|SUPERIORITY||Difference in Percentage|-6.5||||0.9266219|TWO_SIDED|95.0|-15.4|2.3|||Miettinen & Nurminen|One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0. The reported p-value is nominal.|Based on Miettinen \& Nurminen method stratified by baseline PD-L1 TPS (\<50% versus ≥50%) and baseline ECOG performance status (0 versus 1).|||2.3|-15.4|0.9266219
71732748|NCT04068610|142980553|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3173|TWO_SIDED|95.0|0.6|5.6|||Cochran-Mantel-Haenszel|P-value for comparison of treatment arms obtained from stratified Cochran-Mantel-Haenszel test stratified by the location of the primary tumor.||||5.6|0.6|0.3173
71732749|NCT00300677|142980589|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
71732750|NCT00300677|142980589|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
71732751|NCT00300677|142980590|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of the adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||467.43|192.91|
71732752|NCT00300677|142980590|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||300.00|123.81|
71739443|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.48|||||TWO_SIDED|95.0|1.18|1.85|||ANOVA|The ANOVA model on the log10 transformation of the concnetration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.85|1.18|
71889156|NCT03400800|143299488|SUPERIORITY||Mean Difference (Final Values)|-38.94|||<|0.0001|TWO_SIDED|95.0|-41.21|-36.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-36.67|-41.21|<0.0001
71732753|NCT00300677|142980591|SUPERIORITY_OR_OTHER||predose: ratio adjusted geometric means|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
71732754|NCT00300677|142980591|SUPERIORITY_OR_OTHER||postdose: ratio adjusted geometric means|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
71732755|NCT00300677|142980592|SUPERIORITY_OR_OTHER||predose: ratio adjusted mean|12.39||||||90.0|7.09|21.65|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plama (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||21.65|7.09|
71732756|NCT00300677|142980592|SUPERIORITY_OR_OTHER||postdose: ratio adjusted mean|31.57||||||90.0|18.06|55.18|||ANOVA|Mixed-effects analysis of variance model with time, compartment, and time by compartment interaction as fixed effects and subjects as random effects.|Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.||55.18|18.06|
71732757|NCT00443781|142980600|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||McNemar|Exact test was used.||Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.||||0.002
71732758|NCT02066415|142980601|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.04."|Difference in LS Means|-2.46|||<|0.001|TWO_SIDED|95.0|-3.52|-1.39|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.39|-3.52|<0.001
71732759|NCT02066415|142980601|SUPERIORITY|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.01."|Difference in LS Means|-2.45|||<|0.001|TWO_SIDED|95.0|-3.51|-1.38|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.38|-3.51|<0.001
71732760|NCT02066415|142980602|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.46|3.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.27|1.46|<0.001
71732761|NCT02066415|142980602|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.56|3.51|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).||3.51|1.56|<0.001
71732762|NCT02066415|142980603|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-1.86|||<|0.001|TWO_SIDED|95.0|-2.6|-1.13|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.13|-2.60|<0.001
71732763|NCT02066415|142980603|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-2.55|||<|0.001|TWO_SIDED|95.0|-3.28|-1.82|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.82|-3.28|<0.001
71732764|NCT02066415|142980604|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-9.54||||0.28|TWO_SIDED|95.0|-26.98|7.9|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||7.90|-26.98|0.28
71831619|NCT03473340|143167613|SUPERIORITY|||||||0.77367872|||||||Welch Two Sample t-test|||P-Value provided is for net change only.||||0.77367872
71732765|NCT02066415|142980604|SUPERIORITY|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-19.31||||0.03|TWO_SIDED|95.0|-36.71|-1.92|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.||-1.92|-36.71|0.030
71732766|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.33|0.75|
71831620|NCT03473340|143167614|SUPERIORITY|||||||0.68595748|||||||t-test, 2 sided|||P-Value provided is for net change only.||||0.68595748
71831621|NCT03473340|143167615|SUPERIORITY|||||||0.00127634|||||||Fisher Exact|||||||0.00127634
71831622|NCT03473340|143167616|SUPERIORITY|||||||0.80904544|||||||Fisher Exact|||||||0.80904544
71889157|NCT03400800|143299489|SUPERIORITY||Mean Difference (Final Values)|-43.32|||<|0.0001|TWO_SIDED|95.0|-46.04|-40.6||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares means difference from Placebo|||-40.60|-46.04|<0.0001
71732767|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.24|1.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.94|1.24|
71732768|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||TWO_SIDED|95.0|0.74|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.41|0.74|
71732769|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|1.01|2.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.00|1.01|
71732770|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.18|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.51|1.18|
71732771|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.07|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.07|
71831623|NCT03394885|143167622|OTHER||Exact Binomial Confidence Interval|83.0|||||TWO_SIDED|95.0|66.0|100.0||||||||100|66|
71831624|NCT02515305|143167635|EQUIVALENCE|provides 85% power of success|equivalence ratio|97.54|||||TWO_SIDED|90.0|94.6|104.7||No p-value calculated, just a T/R ratio and 90% confidence interval for the bioequivalence analysis|Fieller's method|||||104.7|94.6|
71889158|NCT01412957|143299513|SUPERIORITY_OR_OTHER||Normal score|-2.59||||0.0096|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.||||0.0096
71831625|NCT02515305|143167636|EQUIVALENCE|provides 85% power of success|Equivalence ratio|100.1|||||TWO_SIDED|90.0|96.0|109.3|||Fieller's method|||||109.3|96|
71831626|NCT03949335|143167637|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71831627|NCT03949335|143167638|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71831628|NCT03949335|143167639|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71831629|NCT03949335|143167640|NON_INFERIORITY|Noninferiority margin equals -0.1|Mean Difference (Final Values)|-0.031|||||TWO_SIDED|95.0|-0.053|-0.01||Success criteria was evaluated using lower confidence interval. No P-Value was calculated.||||||-0.010|-0.053|
71831630|NCT03949335|143167642|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71831631|NCT01351272|143167643|SUPERIORITY||||||=|0.09|||||||SPM two-sample t-test|||||||=0.09
71831632|NCT01351272|143167644|SUPERIORITY||||||=|0.16|||||||t-test, 1 sided|||||||= 0.16
71831633|NCT01351272|143167645|SUPERIORITY||||||=|0.09|||||||t-test, 1 sided|||||||= 0.09
71889159|NCT01412957|143299514|SUPERIORITY_OR_OTHER||Normal score|-6.08|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.||||<0.0001
71659164|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.87||||0.049|TWO_SIDED|95.0|0.0|1.73|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.73|0.00|0.049
71659165|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.239|TWO_SIDED|95.0|-0.35|1.39|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.39|-0.35|0.239
71659166|NCT02912650|142833426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.27|TWO_SIDED|95.0|-0.27|0.96|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||0.96|-0.27|0.270
71659167|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.031|TWO_SIDED|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|0.01|0.031
71659168|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.527|TWO_SIDED|95.0|-0.06|0.12|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.12|-0.06|0.527
71659169|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.386|TWO_SIDED|95.0|-0.14|0.05|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.05|-0.14|0.386
71659170|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.084|TWO_SIDED|95.0|-0.02|0.25|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.25|-0.02|0.084
71659171|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.006|TWO_SIDED|95.0|0.06|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|0.06|0.006
71659172|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.135|TWO_SIDED|95.0|-0.17|0.02|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.02|-0.17|0.135
71659173|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
71659174|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.062|TWO_SIDED|95.0|-0.01|0.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.27|-0.01|0.062
71659175|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.977|TWO_SIDED|95.0|-0.14|0.14|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.14|-0.14|0.977
71659176|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.6|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.21|<0.001
71659177|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|||<|0.001|TWO_SIDED|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.34|<0.001
71659178|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.069|TWO_SIDED|95.0|-0.27|0.01|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.01|-0.27|0.069
71659179|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.14|||<|0.001|TWO_SIDED|95.0|0.9|1.38|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.90|<0.001
71772538|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.6083|TWO_SIDED|95.0|-0.024|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.041|-0.024|0.6083
71775091|NCT01920555|143050513|SUPERIORITY||Mean Difference (Final Values)|-5.15||||0.33|TWO_SIDED|95.0|-12.44|2.14||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.14|-12.44|0.33
71659180|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|||<|0.001|TWO_SIDED|95.0|0.12|0.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.46|0.12|<0.001
71659181|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.011|TWO_SIDED|95.0|0.05|0.39|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.39|0.05|0.011
71659182|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.61|1.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.61|< 0.001
71659183|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|||<|0.001|TWO_SIDED|95.0|0.67|1.16|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.16|0.67|<0.001
71659184|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.427|TWO_SIDED|95.0|-0.24|0.1|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.10|-0.24|0.427
71659185|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|1.11|1.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.60|1.11|<0.001
71659186|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.002|TWO_SIDED|95.0|0.1|0.44|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.10|0.002
71659187|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.23|0.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.58|0.23|<0.001
71659188|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.84|1.33|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.33|0.84|<0.001
71659189|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95|||<|0.001|TWO_SIDED|95.0|0.7|1.2|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.70|<0.001
71659190|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.123|TWO_SIDED|95.0|-0.04|0.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.31|-0.04|0.123
71659191|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|1.14|1.67|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|1.14|<0.001
71659192|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.012|TWO_SIDED|95.0|0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.05|0.012
71659193|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.38|0.75|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.75|0.38|<0.001
71659194|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|||<|0.001|TWO_SIDED|95.0|0.9|1.43|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.90|<0.001
71659195|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84|||<|0.001|TWO_SIDED|95.0|0.57|1.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.11|0.57|<0.001
71659196|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.14|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|0.14|<0.001
71659197|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|||<|0.001|TWO_SIDED|95.0|1.11|1.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|1.11|<0.001
71659198|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.002|TWO_SIDED|95.0|0.11|0.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.48|0.11|0.002
71659199|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.56|0.95|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.56|<0.001
71659200|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.82|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.36|0.82|<0.001
71659201|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|||<|0.001|TWO_SIDED|95.0|0.35|0.9|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|0.35|<0.001
71732772|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.79|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|0.79|
71732773|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||TWO_SIDED|95.0|0.58|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.25|0.58|
71659202|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||<|0.001|TWO_SIDED|95.0|0.27|0.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.27|<0.001
71659203|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|1.06|1.61|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|1.06|<0.001
71659204|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.49|0.10|0.003
71659205|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|||<|0.001|TWO_SIDED|95.0|0.58|0.98|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.98|0.58|<0.001
71659206|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04|||<|0.001|TWO_SIDED|95.0|0.76|1.32|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|0.76|<0.001
71659207|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|<0.001
71659208|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.29|0.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.68|0.29|<0.001
71831634|NCT01212991|143167646|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.706|||<|0.0001|TWO_SIDED|95.0|0.596|0.837||A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p\<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \<1 favoring enzalutamide.|||0.837|0.596|<0.0001
71831635|NCT01212991|143167647|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.186|||<|0.0001|TWO_SIDED|95.0|0.149|0.231||The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.231|0.149|<0.0001
71831636|NCT01212991|143167648|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.718|||<|0.0001||95.0|0.61|0.844||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.844|0.610|<0.0001
71831637|NCT01212991|143167649|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.349|||<|0.0001||95.0|0.303|0.403||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.403|0.303|<0.0001
71889160|NCT01412957|143299515|SUPERIORITY_OR_OTHER||Normal score|-2.47||||0.0135|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.||||0.0135
71659209|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|1.00|<0.001
71659210|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.50|0.10|0.003
71659211|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.51|0.91|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.91|0.51|<0.001
71659212|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.7|1.27|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.70|<0.001
71772539|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001||||0.9401|TWO_SIDED|95.0|-0.029|0.027||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.027|-0.029|0.9401
71659213|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.29|0.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.29|<0.001
71659214|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
71772540|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018||||0.295|TWO_SIDED|95.0|-0.051|0.016||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.016|-0.051|0.2950
71772541|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003||||0.8817|TWO_SIDED|95.0|-0.031|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.037|-0.031|0.8817
71659215|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.001|TWO_SIDED|95.0|0.81|1.38|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.81|<0.001
71659216|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.014|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.014
71659217|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.45|0.86|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.45|<0.001
71659218|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.85|||<|0.001|TWO_SIDED|95.0|0.56|1.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.13|0.56|<0.001
71659219|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.003|TWO_SIDED|95.0|0.15|0.73|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|0.15|0.003
71772542|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6072|TWO_SIDED|95.0|-0.037|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.022|-0.037|0.6072
71772543|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.6259|TWO_SIDED|95.0|-0.06|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.036|-0.060|0.6259
71772544|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.2807|TWO_SIDED|95.0|-0.023|0.076||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.076|-0.023|0.2807
71772545|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.008||||0.7224|TWO_SIDED|95.0|-0.035|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.050|-0.035|0.7224
71831638|NCT01212991|143167650|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.169|||<|0.0001||95.0|0.147|0.195||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0167 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with \< 1 favoring enzalutamide.|||0.195|0.147|<0.0001
71831639|NCT01212991|143167651|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rates|74.51|||<|0.0001||95.0|71.45|77.57||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.025 for this analysis.|Cochran-Mantel-Haenszel|||||77.57|71.45|<0.0001
71831640|NCT01212991|143167652|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|53.85|||<|0.0001||95.0|48.53|59.17||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.|Cochran-Mantel-Haenszel|||||59.17|48.53|<0.0001
71659220|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.001|TWO_SIDED|95.0|0.21|0.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.21|<0.001
71659221|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|||<|0.001|TWO_SIDED|95.0|0.62|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.62|<0.001
71659222|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.041|TWO_SIDED|95.0|0.01|0.42|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|0.01|0.041
71659223|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.35|0.76|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.35|<0.001
71659224|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.41|0.99|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.99|0.41|<0.001
71659225|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.018|TWO_SIDED|95.0|0.06|0.65|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.06|0.018
71659226|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.001|TWO_SIDED|95.0|0.14|0.55|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.55|0.14|0.001
71659227|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|||<|0.001|TWO_SIDED|95.0|0.48|1.05|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.48|<0.001
71732774|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||TWO_SIDED|95.0|0.94|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.93|0.94|
71889161|NCT01412957|143299516|SUPERIORITY_OR_OTHER||Normal score|-5.98|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score \< 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.||||<0.0001
71889162|NCT01412957|143299517|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.89|||<|0.0001|TWO_SIDED|95.0|7.47|123.77|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||123.77|7.47|<0.0001
71732775|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||TWO_SIDED|95.0|0.96|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.61|0.96|
71732776|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.09|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.12|1.09|
71732777|NCT00574548|142980642|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|1.86|4.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.35|1.86|
71732778|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.43|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.57|1.43|
71732779|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.95|3.16|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.16|1.95|
71732780|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.12|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.96|1.12|
71772546|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.8532|TWO_SIDED|95.0|-0.08|0.067||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.067|-0.080|0.8532
71772547|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.3116|TWO_SIDED|95.0|-0.038|0.116||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.116|-0.038|0.3116
71659228|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.045|TWO_SIDED|95.0|0.0|0.4|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|0.00|0.045
71732781|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.4|||||TWO_SIDED|95.0|1.67|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.31|1.67|
71732782|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||TWO_SIDED|95.0|1.19|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.47|1.19|
71732783|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|4.3|||||TWO_SIDED|95.0|2.76|6.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||6.61|2.76|
71732784|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|3.3|||||TWO_SIDED|95.0|1.97|5.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||5.45|1.97|
71732785|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||TWO_SIDED|95.0|0.98|2.1|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.10|0.98|
71732786|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||TWO_SIDED|95.0|1.32|2.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.69|1.32|
71732787|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.27|2.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.07|1.27|
71732788|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.96|3.74|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.74|1.96|
71732789|NCT00574548|142980643|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||TWO_SIDED|95.0|1.05|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC / 23vPS\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.45|1.05|
71772548|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.6246|TWO_SIDED|95.0|-0.049|0.082||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.082|-0.049|0.6246
71659229|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.24|0.64|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|0.24|<0.001
71732790|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.54|
71732791|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.49|0.99|
71732792|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.68|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.68|0.43|
71732793|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.77|0.43|
71732794|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.08|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.08|0.67|
71732795|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.12|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.12|0.71|
71732796|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.24|0.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.49|0.24|
71732797|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.26|0.51|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.51|0.26|
71732798|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.02|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.02|0.60|
71732799|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.54|0.87|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.87|0.54|
71772549|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.8697|TWO_SIDED|95.0|-0.092|0.108||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.108|-0.092|0.8697
71772550|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072||||0.1707|TWO_SIDED|95.0|-0.032|0.176||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.176|-0.032|0.1707
71772551|NCT01227564|143045001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.3732|TWO_SIDED|95.0|-0.049|0.129||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.129|-0.049|0.3732
71732800|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.82|0.53|
71732801|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.69|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.69|
71732802|NCT00574548|142980644|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.15|2.13|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.13|1.15|
71831641|NCT00801983|143167658|SUPERIORITY_OR_OTHER||||||>|0.05|||||||GEE|||Subjects were compared across keyboard types - The percentage of subjects with MSD when using the alternative keyboard were compared to the % of subjects with MSD when they were using the typical keyboard||||>.05
71831642|NCT05135000|143167680|OTHER||Cox Proportional Hazard|0.7||||0.6843|TWO_SIDED|80.0|0.2|2.8|||Log Rank|||||2.8|0.2|0.6843
71831643|NCT03785782|143167686|OTHER|||||||0.2988|||||||Regression, Logistic|||||||0.2988
71831644|NCT03785782|143167687|OTHER|||||||0.36|||||||Regression, Linear|||||||0.36
71831645|NCT03785782|143167688|OTHER|||||||0.43|||||||Regression, Linear|||||||0.43
71732803|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.55|0.75|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.75|0.55|
71732804|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.52|2.01|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||2.01|1.52|
71732805|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.66|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.66|0.49|
71831646|NCT03785782|143167689|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
71831647|NCT03785782|143167690|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
71831648|NCT03785782|143167691|OTHER|||||||0.18|||||||Regression, Linear|||||||0.18
71831649|NCT03785782|143167692|OTHER|||||||0.78|||||||Regression, Linear|||||||0.78
71831650|NCT03785782|143167693|OTHER|||||||0.45|||||||Regression, Linear|||||||0.45
71831651|NCT03785782|143167694|OTHER|||||||0.34|||||||Regression, Linear|||||||0.34
71831652|NCT03785782|143167695|OTHER|||||||0.7465|||||||Regression, Logistic|||||||0.7465
71659230|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|||<|0.001|TWO_SIDED|95.0|0.28|0.84|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.84|0.28|< 0.001
71831653|NCT03785782|143167696|OTHER|||||||0.0466|||||||Regression, Logistic|||||||0.0466
71831654|NCT03785782|143167697|OTHER|||||||0.1567|||||||Regression, Logistic|||||||0.1567
71831655|NCT03785782|143167698|OTHER|||||||0.1837|||||||Regression, Logistic|||||||0.1837
71831656|NCT03785782|143167699|OTHER|||||||0.7447|||||||Regression, Logistic|||||||0.7447
71831657|NCT03785782|143167700|OTHER|||||||0.0739|||||||Regression, Logistic|||||||0.0739
71831658|NCT03785782|143167701|OTHER|||||||0.9995|||||||Regression, Logistic|||||||0.9995
71831659|NCT05777785|143167703|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|0.9789||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
71831660|NCT05777785|143167705|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.027|TWO_SIDED||||||t-test, 2 sided|||||||0.027
71831661|NCT05777785|143167706|SUPERIORITY|Power analysis determined that a sample size of 90 participants will have 80% power to detect an effect size of 0.30 (Cohen's D) using a paired t-test with a 0.05 two-sided significance level.|Mean Difference (Final Values)|2.09||||0.029|TWO_SIDED||||||t-test, 2 sided|||||||0.029
71831662|NCT02763319|143167714|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.468|TWO_SIDED|95.0|0.837|1.351|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System (IWRS). Rituximab + bendamustine was the reference treatment group.|||1.351|0.837|0.468
71831663|NCT02763319|143167715|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.568|TWO_SIDED|95.0|0.586|1.33|||Inverse normal test|The Inverse Normal method combines information (p-value) from the interim analysis and information from the final analysis.|The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per the Interactive Web Response System. Rituximab + bendamustine is the reference treatment group.|||1.330|0.586|0.568
71659231|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.027|TWO_SIDED|95.0|0.04|0.61|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.61|0.04|0.027
71659232|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|0.04|0.020
71659233|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|||<|0.001|TWO_SIDED|95.0|0.29|0.85|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.85|0.29|<0.001
71659234|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.374|TWO_SIDED|95.0|-0.11|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.11|0.374
71659235|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.14|0.54|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|0.14|<0.001
71659236|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.2|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.76|0.20|<0.001
71659237|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.106|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.106
71659238|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.013|TWO_SIDED|95.0|0.05|0.45|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|0.05|0.013
71659239|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.006|TWO_SIDED|95.0|0.11|0.67|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|0.11|0.006
71659240|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.796|TWO_SIDED|95.0|-0.17|0.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.22|-0.17|0.796
71659241|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.104|TWO_SIDED|95.0|-0.03|0.36|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.36|-0.03|0.104
71831664|NCT02763319|143167716|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.812|1.779|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.779|0.812|
71659242|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.01|TWO_SIDED|95.0|0.09|0.65|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.65|0.09|0.010
71659243|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.114|TWO_SIDED|95.0|-0.05|0.51|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.51|-0.05|0.114
71659244|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.168|TWO_SIDED|95.0|-0.06|0.34|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.34|-0.06|0.168
71732806|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|1.03|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.03|0.67|
71831665|NCT02763319|143167717|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.778|3.041|||||||A Cochran-Mantel-Haenszel (CMH) test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.041|0.778|
71659245|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.022|TWO_SIDED|95.0|0.05|0.59|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.59|0.05|0.022
71659246|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.62|TWO_SIDED|95.0|-0.14|0.24|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.24|-0.14|0.620
71659247|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.164|TWO_SIDED|95.0|-0.06|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.33|-0.06|0.164
71659248|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.052|TWO_SIDED|95.0|0.0|0.54|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.54|-0.00|0.052
71659249|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.196|TWO_SIDED|95.0|-0.09|0.45|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.45|-0.09|0.196
71659250|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.364|TWO_SIDED|95.0|-0.1|0.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.28|-0.10|0.364
71659251|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.071|TWO_SIDED|95.0|-0.02|0.52|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.02|0.071
71659252|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.865||95.0|-0.2|0.17|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.20|0.865
71659253|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.238|TWO_SIDED|95.0|-0.08|0.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.30|-0.08|0.238
71831666|NCT02763319|143167718|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.938|1.745|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.745|0.938|
71659254|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.054|TWO_SIDED|95.0|0.0|0.53|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.53|-0.00|0.054
71659255|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.335|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.40|-0.14|0.335
71659256|NCT02912650|142833427|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.176|TWO_SIDED|95.0|-0.06|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.06|0.176
71659257|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.002|TWO_SIDED|95.0|0.18|0.77|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.77|0.18|0.002
71659258|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.098|TWO_SIDED|95.0|-0.03|0.38|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.38|-0.03|0.098
71659259|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.719|TWO_SIDED|95.0|-0.25|0.17|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.17|-0.25|0.719
71659260|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.048|TWO_SIDED|95.0|0.0|0.6|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.60|0.00|0.048
71732807|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.57|0.79|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.79|0.57|
71732808|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.52|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.52|0.35|
71831667|NCT02763319|143167719|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.673|2.035|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|2.035|0.673|
71831668|NCT02763319|143167720|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.875|1.452|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.452|0.875|
71659261|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|||<|0.001|TWO_SIDED|95.0|0.21|0.81|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.81|0.21|<0.001
71659262|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.046|TWO_SIDED|95.0|-0.42|0.0|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||-0.00|-0.42|0.046
71659263|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.52|||<|0.001|TWO_SIDED|95.0|1.05|1.99|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.99|1.05|<0.001
71659264|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.069|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.63|-0.02|0.069
71659265|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.604|TWO_SIDED|95.0|-0.24|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.42|-0.24|0.604
71659266|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|||<|0.001|TWO_SIDED|95.0|0.75|1.69|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.69|0.75|<0.001
71659267|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|||<|0.001|TWO_SIDED|95.0|0.96|1.9|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.90|0.96|<0.001
71659268|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.2|TWO_SIDED|95.0|-0.54|0.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.11|-0.54|0.200
71659269|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.89|||<|0.001|TWO_SIDED|95.0|2.32|3.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.46|2.32|<0.001
71659270|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
71659271|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.008|TWO_SIDED|95.0|0.14|0.95|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.95|0.14|0.008
71659272|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.26|||<|0.001|TWO_SIDED|95.0|1.69|2.83|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.83|1.69|<0.001
71659273|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|||<|0.001|TWO_SIDED|95.0|1.77|2.91|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.91|1.77|<0.001
71831669|NCT02763319|143167721|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.682|1.626|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.626|0.682|
71831670|NCT02763319|143167722|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.829|1.985|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|1.985|0.829|
71831671|NCT02763319|143167723|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|0.755|3.457|||||||A CMH test stratified by Baseline stratification factors was performed for response variable coded as follows: 1 for response (CR or PR) and 0 for nonresponse (stable disease \[SD\] or progressive disease \[PD\] or unknown).|3.457|0.755|
71831672|NCT02763319|143167724|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.831|1.416|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.416|0.831|
71659274|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.685|TWO_SIDED|95.0|-0.49|0.32|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.32|-0.49|0.685
71659275|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|2.77|3.93|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.93|2.77|<0.001
71659276|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.001|TWO_SIDED|95.0|0.26|1.07|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.07|0.26|0.001
71659277|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.57|1.39|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.39|0.57|<0.001
71659278|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.69|||<|0.001|TWO_SIDED|95.0|2.11|3.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.27|2.11|<0.001
71659279|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.79|2.96|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.79|<0.001
71659280|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.132|TWO_SIDED|95.0|-0.1|0.73|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.73|-0.10|0.132
71659281|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|||<|0.001|TWO_SIDED|95.0|2.88|4.13|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.13|2.88|<0.001
71659282|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.007|TWO_SIDED|95.0|0.17|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|0.17|0.007
71659283|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35|||<|0.001|TWO_SIDED|95.0|0.91|1.8|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.80|0.91|<0.001
71659284|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.27|3.52|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.52|2.27|<0.001
71659285|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.001|TWO_SIDED|95.0|1.52|2.79|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.79|1.52|<0.001
71831673|NCT02763319|143167725|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.633|1.595|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.595|0.633|
71659286|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.001|TWO_SIDED|95.0|0.3|1.19|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|0.30|0.001
71659287|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|||<|0.001|TWO_SIDED|95.0|2.79|4.09|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.09|2.79|<0.001
71659288|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.003|TWO_SIDED|95.0|0.24|1.15|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.15|0.24|0.003
71659289|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.39|2.31|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.31|1.39|<0.001
71659290|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.74|||<|0.001|TWO_SIDED|95.0|2.1|3.39|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.39|2.10|<0.001
71659291|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.59|||<|0.001|TWO_SIDED|95.0|0.94|2.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|0.94|< 0.001
71659292|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15|||<|0.001|TWO_SIDED|95.0|0.69|1.61|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.69|<0.001
71659293|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|3.33|||<|0.001|TWO_SIDED|95.0|2.67|4.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|2.67|<0.001
71659294|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74||||0.002|TWO_SIDED|95.0|0.27|1.2|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.20|0.27|0.002
71659295|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|1.47|2.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.41|1.47|<0.001
71659296|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|||<|0.001|TWO_SIDED|95.0|1.93|3.26|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|1.93|<0.001
71659297|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|||<|0.001|TWO_SIDED|95.0|0.73|2.07|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.07|0.73|<0.001
71831674|NCT02763319|143167726|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.794|1.244|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.244|0.794|
71831675|NCT02763319|143167727|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.57|1.22|||||||The hazard ratio estimate for treatment was based on a stratified Cox model with stratification factors as per IWRS. Rituximab + bendamustine was the reference treatment group.|1.220|0.570|
71659298|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|||<|0.001|TWO_SIDED|95.0|0.73|1.67|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.67|0.73|<0.001
71659299|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|3.19|||<|0.001|TWO_SIDED|95.0|2.51|3.87|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.87|2.51|<0.001
71659300|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76||||0.002|TWO_SIDED|95.0|0.29|1.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.23|0.29|0.002
71659301|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.85|||<|0.001|TWO_SIDED|95.0|1.37|2.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.33|1.37|< 0.001
71659302|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.43|||<|0.001|TWO_SIDED|95.0|1.75|3.11|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.11|1.75|<0.001
71659303|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|||<|0.001|TWO_SIDED|95.0|0.66|2.03|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.03|0.66|<0.001
71659304|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.61|1.56|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.56|0.61|<0.001
71659305|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.65|||<|0.001|TWO_SIDED|95.0|1.95|3.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.35|1.95|<0.001
71659306|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
71659307|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.73|||<|0.001|TWO_SIDED|95.0|1.24|2.22|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.22|1.24|<0.001
71659308|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.05|||<|0.001|TWO_SIDED|95.0|1.35|2.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.74|1.35|<0.001
71659309|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92||||0.01|TWO_SIDED|95.0|0.22|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.62|0.22|0.010
71659310|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12|||<|0.001|TWO_SIDED|95.0|0.63|1.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.61|0.63|<0.001
71732809|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.69|0.41|
71732810|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.15|0.75|
71732811|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.85|0.58|
71732812|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.74|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.74|0.58|
71732813|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.39|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||1.39|0.89|
71732814|NCT00574548|142980645|NON_INFERIORITY_OR_EQUIVALENCE|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.73|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.||0.73|0.50|
71732815|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.03|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.03|
71732816|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.18|1.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||1.89|1.18|
71772552|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.7259|TWO_SIDED|95.0|-0.04|0.028||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.028|-0.040|0.7259
71772553|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.3517|TWO_SIDED|95.0|-0.018|0.051||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.051|-0.018|0.3517
71772554|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.7311|TWO_SIDED|95.0|-0.024|0.035||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.||0.035|-0.024|0.7311
71772555|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008||||0.6446|TWO_SIDED|95.0|-0.041|0.026||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.026|-0.041|0.6446
71831676|NCT01951170|143167760|SUPERIORITY_OR_OTHER|||||||0.83||||||Change in mTSS scores from baseline to Week 24.|Wilcoxon signed rank test|||||||0.83
71831677|NCT01305252|143167780|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71732817|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|2.07|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.55|2.07|
71732818|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.77|3.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.61|1.77|
71732819|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.7|||||TWO_SIDED|95.0|1.94|3.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.88|1.94|
71732820|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|8.5|||||TWO_SIDED|95.0|5.68|12.6|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||12.60|5.68|
71732821|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|6.7|||||TWO_SIDED|95.0|4.45|10.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||10.22|4.45|
71772556|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.064|TWO_SIDED|95.0|-0.002|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.066|-0.002|0.0640
71772557|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012||||0.4057|TWO_SIDED|95.0|-0.017|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.||0.041|-0.017|0.4057
71772558|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.5742|TWO_SIDED|95.0|-0.066|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.037|-0.066|0.5742
71772559|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1336|TWO_SIDED|95.0|-0.013|0.093||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.093|-0.013|0.1336
71831678|NCT01305252|143167780|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71831679|NCT01305252|143167783|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71831680|NCT01305252|143167783|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71732822|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|1.5|||||TWO_SIDED|95.0|1.02|2.18|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||2.18|1.02|
71831681|NCT04512482|143167786|SUPERIORITY|||||||0.044|||||||ANOVA|||A power analysis determined that a sample size of forty-five (45) subjects would possess 90% power to detect an effect size of 0.5 between the intervention and control legs of the crossover design. With 43 total subjects the study had between 85 and 90% power.||||.044
71831682|NCT02706717|143167854|SUPERIORITY||Mean Difference (Net)|-51.3||||0.6|TWO_SIDED|95.0|-246.0|143.9|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||143.9|-246|0.60
71732823|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.8|||||TWO_SIDED|95.0|2.01|3.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.89|2.01|
71732824|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.92|3.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.13|1.92|
71659311|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||<|0.001|TWO_SIDED|95.0|1.47|2.88|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.88|1.47|<0.001
71831683|NCT02706717|143167860|SUPERIORITY||Mean Difference (Net)|0.042||||0.51|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.17|-0.09|0.51
71659312|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.022|TWO_SIDED|95.0|0.08|1.06|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.06|0.08|0.022
71659313|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.95|1.95|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.95|0.95|<0.001
71659314|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|0.9|2.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.30|0.90|<0.001
71659315|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72||||0.045|TWO_SIDED|95.0|0.02|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.43|0.02|0.045
71659316|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.88|||<|0.001|TWO_SIDED|95.0|0.38|1.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.38|0.38|<0.001
71659317|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78|||<|0.001|TWO_SIDED|95.0|1.09|2.47|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.47|1.09|<0.001
71659318|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.024|TWO_SIDED|95.0|0.07|1.04|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.04|0.07|0.024
71831684|NCT02706717|143167861|SUPERIORITY||Mean Difference (Net)|28.4||||0.09|TWO_SIDED|95.0|-3.6|71.0|||t-test, 2 sided|2-sample t-test with equal variance|"The estimation parameter is the percent difference between the geometric mean fold changes.~With d-dimer data log10 transformed, this is (exp(Visbiome ES mean minus placebo mean) - 1)\*100."|||71.0|-3.6|0.09
71831685|NCT02706717|143167864|SUPERIORITY||Mean Difference (Net)|-32.7||||0.29|TWO_SIDED|95.0|-93.5|28.2|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||28.2|-93.5|0.29
71659319|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.16|||<|0.001|TWO_SIDED|95.0|0.67|1.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.65|0.67|<0.001
71659320|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23|||<|0.001|TWO_SIDED|95.0|0.54|1.92|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.92|0.54|<0.001
71659321|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62||||0.079|TWO_SIDED|95.0|-0.07|1.32|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.32|-0.07|0.079
71659322|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.015|TWO_SIDED|95.0|0.12|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.09|0.12|0.015
71659323|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|||<|0.001|TWO_SIDED|95.0|0.56|1.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.56|<0.001
71659324|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.438|TWO_SIDED|95.0|-0.29|0.67|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.67|-0.29|0.438
71659325|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.001|TWO_SIDED|95.0|0.31|1.29|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.29|0.31|0.001
71659326|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.003|TWO_SIDED|95.0|0.37|1.75|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.75|0.37|0.003
71659327|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45||||0.204|TWO_SIDED|95.0|-0.25|1.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.25|0.204
71659328|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.014|TWO_SIDED|95.0|0.12|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.10|0.12|0.014
71659329|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.018|TWO_SIDED|95.0|0.15|1.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.53|0.15|0.018
71659330|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.867|TWO_SIDED|95.0|-0.44|0.52|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.52|-0.44|0.867
71659331|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.099|TWO_SIDED|95.0|-0.08|0.9|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.08|0.099
71659332|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.024|TWO_SIDED|95.0|0.11|1.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.49|0.11|0.024
71659333|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.228|TWO_SIDED|95.0|-0.27|1.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.27|0.228
71659334|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.136|TWO_SIDED|95.0|-0.12|0.86|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|-0.12|0.136
71659335|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.078|TWO_SIDED|95.0|-0.07|1.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.28|-0.07|0.078
71659336|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.716|TWO_SIDED|95.0|-0.38|0.56|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.56|-0.38|0.716
71732825|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.5|||||TWO_SIDED|95.0|1.8|3.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||3.44|1.80|
71772560|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.013||||0.5734|TWO_SIDED|95.0|-0.033|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.||0.058|-0.033|0.5734
71772561|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.016||||0.7067|TWO_SIDED|95.0|-0.104|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.071|-0.104|0.7067
71772562|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.36|TWO_SIDED|95.0|-0.049|0.132||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.132|-0.049|0.3600
71772563|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013||||0.7454|TWO_SIDED|95.0|-0.065|0.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.||0.090|-0.065|0.7454
71772564|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.9037|TWO_SIDED|95.0|-0.113|0.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.100|-0.113|0.9037
71831686|NCT02706717|143167865|SUPERIORITY||Mean Difference (Net)|-0.02||||0.41|TWO_SIDED|95.0|-0.08|0.04|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.|||0.04|-0.08|0.41
71831687|NCT02706717|143167882|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
71831688|NCT01911169|143167884|OTHER||Cohen's d|0.68|||||TWO_SIDED|||||||||Effect size of primary outcome was calculated||||
71659337|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.197|TWO_SIDED|95.0|-0.16|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.79|-0.16|0.197
71659338|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52||||0.131|TWO_SIDED|95.0|-0.15|1.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.19|-0.15|0.131
71659339|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29||||0.399|TWO_SIDED|95.0|-0.39|0.97|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.97|-0.39|0.399
71659340|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.349|TWO_SIDED|95.0|-0.25|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.70|-0.25|0.349
71732826|NCT00574548|142980646|SUPERIORITY_OR_OTHER||ratio of geometric mean titer|2.9|||||TWO_SIDED|95.0|1.92|4.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (\[13vPnC\] - \[23vPS / 13vPnC\]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.||4.28|1.92|
71659341|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.169|TWO_SIDED|95.0|-0.2|1.12|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.12|-0.20|0.169
71659342|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.937|TWO_SIDED|95.0|-0.48|0.44|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.44|-0.48|0.937
71659343|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.351|TWO_SIDED|95.0|-0.25|0.69|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.69|-0.25|0.351
71732827|NCT02449018|142980667|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.31||0.13|TWO_SIDED|90.0|-0.24|0.79|||ANCOVA|||||0.79|-0.24|0.130
71732828|NCT03995355|142980680|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|11.3|STANDARD_ERROR_OF_MEAN|4.44|||TWO_SIDED|95.0|2.6|20.1|||Linear Mixed Model Analysis||Least square mean difference was calculated as Test minus Control|||20.1|2.6|
71732829|NCT03995355|142980681|NON_INFERIORITY|Subjective overall comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least square mean difference|2.6|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-5.3|10.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||10.4|-5.3|
71732830|NCT03995355|142980682|OTHER||Odds Ratio (OR)|0.967|||||TWO_SIDED|95.0|0.528|1.77|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|||1.770|0.528|
71732831|NCT03995355|142980682|OTHER||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.61|2.203|||Generalized linear Mixed Model Analysis||Odds ratio was calculated as Test over Control. No difference was concluded if 1 fall within the 95% confidence interval for the odds ratio.|30-Day follow-up||2.203|0.610|
71732832|NCT03995355|142980683|OTHER||Odds Ratio (OR)|1.601|||||TWO_SIDED|95.0|0.178|19.616|||Fisher Exact||Odds ratio was calculated as Test over Control|||19.616|0.178|
71732833|NCT03995355|142980684|OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|0.7|15.4|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||15.4|0.7|
71659344|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48||||0.151|TWO_SIDED|95.0|-0.18|1.14|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.14|-0.18|0.151
71732834|NCT03995355|142980685|OTHER||Mean Difference (Net)|9.3|STANDARD_ERROR_OF_MEAN|3.86|||TWO_SIDED|95.0|1.7|17.0|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Least square mean difference was calculated as Test minus Control|||17.0|1.7|
71732835|NCT03426631|142980686|SUPERIORITY||Median Difference (Final Values)|-11.7||||0.47|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.47
71732836|NCT04971941|142980705|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.17||0.001|TWO_SIDED|95.0|0.4|2.1||This P value applies to comparison of IAN with and without DentalVibe|t-test, 2 sided|df =58||Sample size estimation from Nanitsos 2010: Using the P value from the paired T test with 61 degrees of freedom the T statistic calculated at 4.365. From mean difference 9.3 SD was calculated as 16.66 for an effect size of 0.558. This generated a sample size of 44 subjects, receiving 2 injections (1 with DV3 and 1 without), is necessary to attain 95% power for a paired t-test comparing the 2 pain measures at a two-tailed alpha level of 0.05. P value for IAN||2.1|0.4|0.001
71732837|NCT04971941|142980705|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|1.75||0.02|TWO_SIDED|95.0|-1.7|-1.5|||t-test, 2 sided|df= 58||||-1.5|-1.7|0.02
71732838|NCT04971941|142980705|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.74||0.004|TWO_SIDED|95.0|0.4|2.1|||t-test, 2 sided|||||2.1|0.4|0.004
71732839|NCT04971941|142980706|SUPERIORITY||Mean Difference (Net)|4.0||||0.001|TWO_SIDED|14.0|0.4|4.8||This P value applies to comparing IAN with or with DV as measured by SSI tolerability/ability to endure|t-test, 2 sided|||||4.8|0.4|0.001
71732840|NCT04971941|142980706|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71732841|NCT04971941|142980706|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71732842|NCT04971941|142980706|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
71732843|NCT04971941|142980706|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71732844|NCT04971941|142980706|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||||||0.044
71732845|NCT04971941|142980706|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
71659345|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.476|TWO_SIDED|95.0|-0.42|0.9|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.90|-0.42|0.476
71659346|NCT02912650|142833428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.31|TWO_SIDED|95.0|-0.22|0.71|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|-0.22|0.310
71659347|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|7.35|||<|0.001|TWO_SIDED|95.0|6.09|8.61|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||8.61|6.09|<0.001
71659348|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|1.41||||0.002|TWO_SIDED|95.0|0.53|2.28|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.28|0.53|0.002
71732846|NCT04971941|142980706|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
71659349|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|1.98|||<|0.001|TWO_SIDED|95.0|1.09|2.88|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||2.88|1.09|<0.001
71659350|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|5.94|||<|0.001|TWO_SIDED|95.0|4.69|7.2|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.20|4.69|<0.001
71732847|NCT04971941|142980706|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||0.053
71732848|NCT04971941|142980707|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||The null hypothesis is that there is no relation between use of DV and numb times. There were no studies from which to perform a power calculation for this outcome measure||||0.459
71732849|NCT01325714|142980710|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.71||||0.13|TWO_SIDED|95.0|0.45|1.11||This is the p value from the discrete-time Cox regression time-to-event analyses|Regression, Cox|DF = 1|The enhanced usual care arm is the comparison group.|"Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm."||1.11|0.45|0.13
71732850|NCT01325714|142980710|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.77||||0.39|TWO_SIDED|95.0|0.43|1.39||From discrete time-cox regression time-to-event analysis.|Regression, Cox|df = 1|The enhanced usual care arm is the reference group.|Comparison of incidence of non-verbal aggression between treatment groups.||1.39|0.43|0.39
71732851|NCT01325714|142980710|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen's h = .4) between treatment groups in rate of aggression onset (the primary outcome) over a 1-year period, assuming 80% power and type I error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group (anticipated based on estimated rates from prior work) versus 19% for the treatment group|Hazard Ratio (HR)|0.84||||0.84|TWO_SIDED|95.0|0.51|1.37||From discrete-time Cox regression time-to-event analyses|Regression, Cox|df = 1|The usual care arm is the reference group.|Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.||1.37|0.51|0.84
71732852|NCT01325714|142980711|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.46|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 0.86||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.46
71732853|NCT01325714|142980712|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.43||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.||||0.23
71732854|NCT01325714|142980713|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.45||||0.23|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 1.45||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.||||0.23
71732855|NCT01325714|142980714|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.86||||0.62|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 409) = 0.59||Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.||||0.62
71732856|NCT01325714|142980715|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.94||||0.42|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 453) = 0.94.||Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.||||0.42
71772565|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2082|TWO_SIDED|95.0|-0.04|0.181||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.181|-0.040|0.2082
71772566|NCT01227564|143045002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.5044|TWO_SIDED|95.0|-0.063|0.127||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.127|-0.063|0.5044
71659351|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.1|6.63|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||6.63|4.10|<0.001
71732857|NCT01325714|142980716|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|1.1||||0.35|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 457) = 1.10||Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.||||0.35
71732858|NCT01325714|142980717|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|0.11||||0.11|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 2.00||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.||||0.11
71732859|NCT01325714|142980718|SUPERIORITY_OR_OTHER||Results of F value of growth curve model|3.84||||0.01|TWO_SIDED|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 3.84||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.||||0.01
71732860|NCT00721175|142980719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2407407|STANDARD_ERROR_OF_MEAN|0.0920078||0.011|TWO_SIDED|95.0|-0.4210726|-0.0604089|||Two-sample test of proportion|||||-.0604089|-.4210726|0.011
71732861|NCT00721175|142980720|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||Log Rank|||||||0.0021
71732862|NCT00721175|142980722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278744|STANDARD_ERROR_OF_MEAN|0.0929622||0.004|TWO_SIDED|95.0|-0.4609466|-0.0965414|||Two-sample test of proportion|||||-.0965414|-.4609466|0.004
71732863|NCT01561963|142980789|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% confidence interval (CI) limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|96.35|||||TWO_SIDED|90.0|88.56|104.82|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.82|88.56|
71732864|NCT01561963|142980789|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.88|||||TWO_SIDED|90.0|25.63|30.34|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUCt of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.34|25.63|
71831689|NCT01911169|143167884|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||This study was conducted to determine the effect size for in change in FMD at 16 weeks with 25(OH) therapy. For change in FMD at 16 weeks with 25(OH)D repletion, based on this effect size, to detect significant differences between 2 groups, assuming 1) normally distributed data, 2) the same effect size, 3) alpha= 0.05, and 4) a power of 0.8, 35 patients in each group would be required. Therefore, this was designed as a pilot to determine effect size.||||> 0.05
71831690|NCT03873337|143167896|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 25||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at one-month post target quit date (2-months after baseline assessment.||||<0.001
71732865|NCT01561963|142980790|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|95.71|||||TWO_SIDED|90.0|87.99|104.12|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||104.12|87.99|
71732866|NCT01561963|142980790|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|27.96|||||TWO_SIDED|90.0|25.7|30.41|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of AUC∞ of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||30.41|25.70|
71732867|NCT01561963|142980791|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|113.07|||||TWO_SIDED|90.0|103.18|123.91|||||Apremilast + IV Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||123.91|103.18|
71831691|NCT03873337|143167896|SUPERIORITY|||||||0.002||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in scores on the TASQ at 3-months post target quit date (4 months after baseline assessment.||||0.002
71659352|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58||||0.203|TWO_SIDED|95.0|-0.31|1.47|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||1.47|-0.31|0.203
71659353|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.001|TWO_SIDED|95.0|20.1|28.9|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||28.90|20.10|<0.001
71732868|NCT01561963|142980791|EQUIVALENCE|No statistically significant interaction between apremilast and rifampicin was confirmed if both the upper and lower 90% CI limits for the geometric least squares mean ratios of apremilast administered with rifampicin to apremilast alone fell within the no effect boundary of 80% to 125%.|Ratio of Geometric Least Squares Means|56.8|||||TWO_SIDED|90.0|51.84|62.25|||||Apremilast + Multiple Dose Oral Rifampin / Apremilast Alone|The effect of rifampicin on the PK of apremilast was evaluated using a linear mixed effect analysis of variance on the log-transformed values of Cmax of apremilast, to estimate the mean ratio of apremilast administered with and without rifampicin treatment. The model included treatment as fixed effect, and subject as a random effect.||62.25|51.84|
71732869|NCT01561963|142980792|OTHER||Median Difference|-0.25||||0.2656|TWO_SIDED|90.0|-0.75|0.0|||Wilcoxon signed rank test||Apremilast + IV Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-0.75|0.2656
71732870|NCT01561963|142980792|OTHER||Median Difference|-0.5||||0.1141|TWO_SIDED|90.0|-1.0|0.0|||Wilcoxon signed rank test||Apremilast + Multiple Dose Oral Rifampin - Apremilast Alone|Tmax was analyzed using nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||0.00|-1.00|0.1141
71732871|NCT02530996|142980833|OTHER|Power calculations were performed using G\*Power computer software version 3. Sample-size calculations were based on the number of patients needed to detect significant differences in FMD between placebo and BH4.|Mean Difference (Net)|1.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Statistics were performed using SPSS software (IBM, Chicago, IL). Paired t-tests were used to identify significant changes in measured variables between placebo and BH4. Unpaired t-tests were used to identify significant changes in measured variables between ordered groups. Based on data published in PMID: 25511849 power calculations for this study of SSc patients were made.||||<0.05
71732872|NCT04268745|142980844|SUPERIORITY||Mean Difference (Final Values)|-13.603||||0.027|TWO_SIDED|95.0|-25.634|-1.573|||Regression, Linear|||||-1.573|-25.634|0.027
71772567|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.7687|TWO_SIDED|95.0|-0.23|0.17||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.17|-0.23|0.7687
71772568|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.6804|TWO_SIDED|95.0|-0.16|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.24|-0.16|0.6804
71772569|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9452|TWO_SIDED|95.0|-0.17|0.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.18|-0.17|0.9452
71772570|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8825|TWO_SIDED|95.0|-0.27|0.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.23|-0.27|0.8825
71772571|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8791|TWO_SIDED|95.0|-0.28|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.24|-0.28|0.8791
71831692|NCT03873337|143167897|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at one-month post target quit date (2-months after baseline assessment.||||<0.001
71732873|NCT04268745|142980845|SUPERIORITY||Median Difference (Final Values)|6.405||||0.0001|TWO_SIDED|95.0|4.474|8.335|||Regression, Linear|||||8.335|4.474|0.0001
71659354|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|4.44||||0.005|TWO_SIDED|95.0|1.37|7.52|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||7.52|1.37|0.005
71659355|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|11.36|||<|0.001|TWO_SIDED|95.0|8.23|14.48|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||14.48|8.23|<0.001
71659356|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|20.06|||<|0.001|TWO_SIDED|95.0|15.66|24.45|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||24.45|15.66|<0.001
71659357|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|13.14|||<|0.001|TWO_SIDED|95.0|8.71|17.57|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.57|8.71|<0.001
71659358|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|6.92|||<|0.001|TWO_SIDED|95.0|3.8|10.04|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||10.04|3.80|<0.001
71659359|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|34.83|||<|0.001|TWO_SIDED|95.0|26.09|43.57|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||43.57|26.09|<0.001
71659360|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|5.85||||0.06|TWO_SIDED|95.0|-0.25|11.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||11.95|-0.25|0.060
71659361|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|16.75|||<|0.001|TWO_SIDED|95.0|10.54|22.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||22.95|10.54|<0.001
71659362|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|28.98|||<|0.001|TWO_SIDED|95.0|20.26|37.71|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||37.71|20.26|<0.001
71659363|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|18.08|||<|0.001||95.0|9.29|26.88|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||26.88|9.29|<0.001
71659364|NCT02912650|142833429|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9|||<|0.001|TWO_SIDED|95.0|4.7|17.1|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.||17.10|4.70|<0.001
71732874|NCT04268745|142980846|SUPERIORITY||Mean Difference (Final Values)|-18.703||||0.0002|TWO_SIDED|95.0|-28.235|-9.172|||Regression, Linear|||||-9.172|-28.235|0.0002
71659365|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|2.12|||<|0.001|TWO_SIDED|95.0|1.72|2.51|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.51|1.72|<0.001
71659366|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44||||0.002|TWO_SIDED|95.0|0.16|0.71|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.71|0.16|0.002
71659367|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|||<|0.001|TWO_SIDED|95.0|0.3|0.86|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.86|0.30|<0.001
71659368|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.08|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.08|1.29|<0.001
71659369|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.53|||<|0.001|TWO_SIDED|95.0|1.14|1.93|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.93|1.14|<0.001
71659370|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15||||0.303|TWO_SIDED|95.0|-0.13|0.43|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.43|-0.13|0.303
71659371|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|7.22|||<|0.001|TWO_SIDED|95.0|5.86|8.58|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.58|5.86|<0.001
71659372|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.58||||0.001|TWO_SIDED|95.0|0.63|2.53|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.53|0.63|0.001
71659373|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|3.48|||<|0.001|TWO_SIDED|95.0|2.52|4.45|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.45|2.52|<0.001
71659374|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|||<|0.001|TWO_SIDED|95.0|4.28|6.99|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.99|4.28|<0.001
71659375|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|3.73|||<|0.001|TWO_SIDED|95.0|2.37|5.1|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.10|2.37|<0.001
71659376|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.001|TWO_SIDED|95.0|0.95|2.86|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.86|0.95|<0.001
71732875|NCT04268745|142980847|SUPERIORITY||Mean Difference (Final Values)|8.556||||0.028|TWO_SIDED|95.0|0.938|16.174|||Regression, Linear|||||16.174|0.938|0.028
71732876|NCT04268745|142980848|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.695|TWO_SIDED|95.0|-0.443|0.665|||Regression, Linear|||||0.665|-0.443|0.695
71889163|NCT01412957|143299518|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0|||<|0.0001|TWO_SIDED|95.0|5.89|101.62|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.||101.62|5.89|<0.0001
71659377|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|8.89|||<|0.001|TWO_SIDED|95.0|7.08|10.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|7.08|<0.001
71659378|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.002|TWO_SIDED|95.0|0.73|3.26|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.26|0.73|0.002
71659379|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|4.48|||<|0.001|TWO_SIDED|95.0|3.2|5.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.77|3.20|<0.001
71659380|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9|||<|0.001|TWO_SIDED|95.0|5.08|8.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.71|5.08|<0.001
71659381|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|4.41|||<|0.001|TWO_SIDED|95.0|2.58|6.24|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.24|2.58|<0.001
71659382|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|2.49|||<|0.001|TWO_SIDED|95.0|1.21|3.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.77|1.21|<0.001
71889164|NCT04722991|143299521|OTHER|Bayesian inference with non-informative priors|Point estimate|-0.015|||||TWO_SIDED|95.0|-0.08|0.029|||||Median of posterior distribution|||0.029|-0.080|
71889165|NCT02246621|143299529|SUPERIORITY||Hazard Ratio (HR)|0.54||||2e-06|TWO_SIDED|95.0|0.418|0.698|||Log Rank|||||0.698|0.418|0.000002
71659383|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|10.42|||<|0.001|TWO_SIDED|95.0|7.76|13.08|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||13.08|7.76|<0.001
71659384|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|2.14||||0.024|TWO_SIDED|95.0|0.28|4.0|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.00|0.28|0.024
71659385|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|5.24|||<|0.001|TWO_SIDED|95.0|3.35|7.12|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.12|3.35|<0.001
71659386|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|8.28|||<|0.001|TWO_SIDED|95.0|5.62|10.93|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.93|5.62|<0.001
71659387|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|5.18|||<|0.001|TWO_SIDED|95.0|2.51|7.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.86|2.51|<0.001
71659388|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.001|TWO_SIDED|95.0|1.22|4.97|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.97|1.22|0.001
71659389|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|2.77|||<|0.001|TWO_SIDED|95.0|1.95|3.59|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.59|1.95|<0.001
71659390|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.023|TWO_SIDED|95.0|0.09|1.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.24|0.09|0.023
71659391|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|||<|0.001|TWO_SIDED|95.0|1.07|2.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.24|1.07|<0.001
71732877|NCT04268745|142980849|SUPERIORITY||Mean Difference (Final Values)|-0.514||||0.469|TWO_SIDED|95.0|-1.901|0.874|||Regression, Linear|||||0.874|-1.901|0.469
71732878|NCT03242252|142980907|SUPERIORITY||Difference in Least Squares (LS) Means|-0.1|STANDARD_ERROR_OF_MEAN|0.076||0.2095|TWO_SIDED|95.0|-0.245|0.054|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of Chronic Kidney Disease (CKD) stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.054|-0.245|0.2095
71732879|NCT03242252|142980907|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.077||0.0021|TWO_SIDED|95.0|-0.386|-0.085|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.085|-0.386|0.0021
71732880|NCT03242252|142980908|SUPERIORITY||Difference in LS Means|-0.587|STANDARD_ERROR_OF_MEAN|0.2397||0.0144|TWO_SIDED|95.0|-1.0564|-0.1169|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.1169|-1.0564|0.0144
71732881|NCT03242252|142980908|SUPERIORITY||Difference in LS Means|-0.478|STANDARD_ERROR_OF_MEAN|0.2368||0.0436|TWO_SIDED|95.0|-0.942|-0.0136|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline FPG as a covariate.||-0.0136|-0.942|0.0436
71659392|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|||<|0.001|TWO_SIDED|95.0|1.29|2.92|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.92|1.29|<0.001
71732882|NCT03242252|142980909|SUPERIORITY||Difference in LS Means|-2.28|STANDARD_ERROR_OF_MEAN|2.034||0.2627|TWO_SIDED|95.0|-6.265|1.709|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1.709|-6.265|0.2627
71732883|NCT03242252|142980909|SUPERIORITY||Difference in LS Means|-2.53|STANDARD_ERROR_OF_MEAN|1.799||0.1602|TWO_SIDED|95.0|-6.052|1.0|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization stratum of CKD stage (3A, 3B) at screening, and country as fixed effects, and baseline SBP as a covariate.||1|-6.052|0.1602
71732884|NCT03242252|142980910|SUPERIORITY||Difference in LS Means|-1.59|STANDARD_ERROR_OF_MEAN|1.301||0.2212|TWO_SIDED|95.0|-4.142|0.958|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.958|-4.142|0.2212
71732885|NCT03242252|142980910|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|1.297||0.2089|TWO_SIDED|95.0|-4.171|0.912|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline SBP as a covariate.||0.912|-4.171|0.2089
71732886|NCT03242252|142980911|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.326|<|0.0001|TWO_SIDED|95.0|-1.92|-0.644|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.644|-1.92|< 0.0001
71732887|NCT03242252|142980911|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|0.339||0.0155|TWO_SIDED|95.0|-1.487|-0.156|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and baseline body weight as a covariate.||-0.156|-1.487|0.0155
71732888|NCT03242252|142980912|SUPERIORITY||Percent Difference|-30.72||||0.0015|TWO_SIDED|95.0|-44.78|-13.07|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-13.07|-44.78|0.0015
71772572|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.8628|TWO_SIDED|95.0|-0.24|0.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.20|-0.24|0.8628
71772573|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7843|TWO_SIDED|95.0|-0.35|0.26||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.26|-0.35|0.7843
71772574|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.0857|TWO_SIDED|95.0|-0.04|0.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.60|-0.04|0.0857
71772575|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.3878|TWO_SIDED|95.0|-0.15|0.39||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.39|-0.15|0.3878
71831693|NCT03873337|143167897|SUPERIORITY||||||<|0.001||||||not adjusted for multiple comparisons|t-test, 1 sided|df = 27||One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day at 3-months post target quit date (4-months after baseline assessment.||||<0.001
71831694|NCT02512965|143167898|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.79|6.69||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factor at randomization.|||6.69|1.79|0.0002
71659393|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11||||0.008|TWO_SIDED|95.0|0.29|1.94|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.94|0.29|0.008
71889166|NCT02246621|143299531|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71889167|NCT02246621|143299533|SUPERIORITY|||||||0.501|||||||Cochran-Mantel-Haenszel|||||||0.501
71889168|NCT02246621|143299534|SUPERIORITY|||||||0.101|||||||Cochran-Mantel-Haenszel|||||||0.101
71732889|NCT03242252|142980912|SUPERIORITY||Percent Difference|-36.18||||0.0003|TWO_SIDED|95.0|-49.91|-18.68|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization stratum of CKD stage (3A, 3B) at screening, country as fixed effects, and and log-transformed baseline UACR as a covariate.||-18.68|-49.91|0.0003
71732890|NCT03242252|142980913|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.23|5.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.21|-2.23|0.4328
71889169|NCT02246621|143299538|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.688|TWO_SIDED||||||Mixed Models Analysis|||||||0.688
71659394|NCT02912650|142833430|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|||<|0.001|TWO_SIDED|95.0|0.41|1.57|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.57|0.41|<0.001
71732891|NCT03242252|142980913|SUPERIORITY||Percentage Difference|1.5||||0.4328|TWO_SIDED|95.0|-2.2|5.17|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||5.17|-2.2|0.4328
71772576|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8918|TWO_SIDED|95.0|-0.39|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.45|-0.39|0.8918
71732892|NCT03242252|142980914|SUPERIORITY||Percentage Difference|6.0||||0.0614|TWO_SIDED|95.0|-0.23|12.21|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||12.21|-0.23|0.0614
71732893|NCT03242252|142980914|SUPERIORITY||Percentage Difference|7.4||||0.023|TWO_SIDED|95.0|1.08|13.65|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening and randomization strata of CKD stage (3A, 3B) at screening.||13.65|1.08|0.023
71732894|NCT01116427|142980921|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.87
71732895|NCT01116427|142980922|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups|Wilcoxon (Mann-Whitney)|||||||0.36
71889170|NCT02246621|143299539|SUPERIORITY||Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|1.39||0.466|TWO_SIDED||||||Mixed Models Analysis|||||||0.466
71889171|NCT01583374|143299542|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.1||||0.4383|TWO_SIDED|95.0|-14.3|6.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel (CMH) weights|||6.2|-14.3|0.4383
71889172|NCT01583374|143299542|SUPERIORITY||Risk Difference (RD)|-1.7||||0.7427|TWO_SIDED|95.0|-12.0|8.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||8.5|-12.0|0.7427
71889173|NCT01583374|143299543|SUPERIORITY||LS Mean Difference|-0.05||||0.8032|TWO_SIDED|95.0|-0.41|0.32|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.32|-0.41|0.8032
71889174|NCT01583374|143299543|SUPERIORITY||LS Mean Difference|-0.17||||0.3624|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.19|-0.53|0.3624
71889175|NCT01583374|143299544|SUPERIORITY||LS Mean Difference|0.03||||0.8618|TWO_SIDED|95.0|-0.33|0.4|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.40|-0.33|0.8618
71659395|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|2.68|3.82|||ANOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.82|2.68|<0.001
71659396|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.002|TWO_SIDED|95.0|0.23|1.03|||ANOVA|||0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.03|0.23|0.002
71659397|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|||<|0.001|TWO_SIDED|95.0|0.46|1.27|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.27|0.46|<0.001
71659398|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|||<|0.001|TWO_SIDED|95.0|2.05|3.19|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.19|2.05|<0.001
71659399|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|2.39|||<|0.001|TWO_SIDED|95.0|1.81|2.96|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.96|1.81|<0.001
71659400|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.258|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||0.64|-0.17|0.258
71659401|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|10.77|||<|0.001|TWO_SIDED|95.0|8.79|12.74|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.74|8.79|<0.001
71772577|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.1233|TWO_SIDED|95.0|-0.09|0.76||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.76|-0.09|0.1233
71772578|NCT01227564|143045003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.3302|TWO_SIDED|95.0|-0.19|0.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||0.55|-0.19|0.3302
71772579|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65||||0.1597|TWO_SIDED|95.0|-0.67|3.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.97|-0.67|0.1597
71772580|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.213|TWO_SIDED|95.0|-4.01|0.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.91|-4.01|0.2130
71772581|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9616|TWO_SIDED|95.0|-2.06|2.16||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||2.16|-2.06|0.9616
71772582|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2143|TWO_SIDED|95.0|-1.06|4.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||4.62|-1.06|0.2143
71772583|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.2151|TWO_SIDED|95.0|-4.87|1.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.12|-4.87|0.2151
71831695|NCT02512965|143167899|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0036|TWO_SIDED|95.0|1.35|4.85|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate stratified by stratification factors at randomization.|||4.85|1.35|0.0036
71831696|NCT02512965|143167900|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.26|TWO_SIDED|95.0|0.46|1.24|||Log Rank|2-sided p-value adjusted for stratification factors at randomization.|Estimate adjusted for stratification factors at randopmization.|||1.24|0.46|0.26
71831697|NCT02512965|143167901|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|95.0|0.48|1.4||2-sided p-value adjusted for stratification factors at randomization.|Log Rank|||||1.40|0.48|0.47
71831698|NCT01185782|143167925|NON_INFERIORITY_OR_EQUIVALENCE|"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.)"|Delta|-3.51|||||TWO_SIDED|95.0|-13.05|6.04|||Chi-squared|||||6.04|-13.05|
71831699|NCT01185782|143167926|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Chi-squared|||||||0.214
71732896|NCT01116427|142980923|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.93
71831700|NCT01185782|143167927|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||t-test, 2 sided|||||||0.087
71831701|NCT01185782|143167928|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||t-test, 2 sided|||||||0.069
71831702|NCT01185782|143167929|SUPERIORITY_OR_OTHER|||||||0.852||95.0|||||Chi-squared|||||||0.852
71831703|NCT01185782|143167930|SUPERIORITY_OR_OTHER|||||||0.102||95.0|||||Chi-squared|||||||0.102
71831704|NCT01185782|143167931|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Chi-squared|||||||0.560
71732897|NCT01116427|142980924|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups|Wilcoxon (Mann-Whitney)|||||||0.68
71732898|NCT01116427|142980925|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED|||||Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups|Wilcoxon (Mann-Whitney)|||||||0.21
71732899|NCT01116427|142980926|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Fisher Exact|||||||0.65
71732900|NCT01116427|142980928|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.13
71732901|NCT01116427|142980929|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED|||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)|||||||0.06
71732902|NCT01116427|142980930|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)|||||||0.07
71732903|NCT01116427|142980931|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.88
71732904|NCT01116427|142980932|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Fisher Exact|||||||0.29
71831705|NCT01185782|143167932|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Chi-squared|||||||0.555
71831706|NCT01185782|143167933|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Chi-squared|||||||0.416
71831707|NCT02507752|143167937|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||< 0.001
71831708|NCT02507752|143167937|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||ANOVA|||Mental component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).||||= 0.014
71831709|NCT02507752|143167939|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.021
71732905|NCT01116427|142980934|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)|||||||0.67
71732906|NCT03973905|142980940|OTHER||Vaccine Effectiveness|65.26|||||TWO_SIDED|95.0|-64.93|92.68|||||Vaccine Effectiveness (VE) was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy (at least 14 days before delivery) at preventing pertussis in infants \<2 months||92.68|-64.93|
71732907|NCT03973905|142980941|OTHER||Vaccine Effectiveness|42.01|||||TWO_SIDED|95.0|-1071.8|97.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||97.13|-1071.80|
71831710|NCT02507752|143167939|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Mean change from Baseline in ESR at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
71831711|NCT02507752|143167940|SUPERIORITY_OR_OTHER||||||=|0.744|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.744
71831712|NCT02507752|143167940|SUPERIORITY_OR_OTHER||||||=|0.646|TWO_SIDED||||||ANOVA|||Mean change from Baseline in CRP at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.646
71831713|NCT02507752|143167941|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71831714|NCT02507752|143167941|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in SJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71831715|NCT02507752|143167942|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71732908|NCT03973905|142980941|OTHER||Vaccine Effectiveness|62.17|||||TWO_SIDED|95.0|-439.75|97.35|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during first or second trimester of pregnancy at preventing pertussis in infants \<2 months||97.35|-439.75|
71732909|NCT03973905|142980941|OTHER||Vaccine Effectiveness|-12.89|||||TWO_SIDED|95.0|-166.37|52.16|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||52.16|-166.37|
71732910|NCT03973905|142980942|OTHER||Vaccine Effectiveness|64.79|||||TWO_SIDED|95.0|-57.51|92.13|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix at any time during pregnancy at preventing pertussis in infants \<2 months||92.13|-57.51|
71732911|NCT03973905|142980943|OTHER||Vaccine Effectiveness|17.65|||||TWO_SIDED|95.0|-12529.0|99.46|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix before pregnancy at preventing pertussis in infants \<2 months||99.46|-12529.0|
71732912|NCT03973905|142980943|OTHER||Vaccine Effectiveness|85.01|||||TWO_SIDED|95.0|-13.91|98.03|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix during third trimester of pregnancy at preventing pertussis in infants \<2 months||98.03|-13.91|
71732913|NCT03973905|142980943|OTHER||Vaccine Effectiveness|37.64|||||TWO_SIDED|95.0|-87.4|79.25|||||VE was estimated as (1-odds ratio) × 100%. The Confidence Interval was calculated based on the conditional binomial distribution of cases in the exposed group and the total number of cases.|To assess the effectiveness of maternal vaccination with Boostrix after pregnancy at preventing pertussis in infants \<2 months||79.25|-87.40|
71732914|NCT02648217|142980944|SUPERIORITY_OR_OTHER||Treatment Contrast|0.02||||0.8426|TWO_SIDED|95.0|-0.2|0.24|||Mixed model for repeated measurements|||The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model.||0.24|-0.20|0.8426
71732915|NCT02411929|142981059|SUPERIORITY_OR_OTHER||Test (oral)/Reference (IV) of means|104.73|||||TWO_SIDED|90.0|101.64|107.91|||||Natural log transformed AUCinf(dn) and AUClast(dn) from Period 1 were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences were exponentiated.|Ratio - Test (oral) / Reference (IV) of means||107.91|101.64|
71732916|NCT02411929|142981069|SUPERIORITY_OR_OTHER||Ratio|110.71|||||||||||||The ratio (Test/Reference) of the geometric means of dose normalized natural log transformed Total 14\^C in Urine will be estimated. Total 14\^C\_Urine\_IV is the Reference formulation and Total 14C\_Urine\_Oral is the Test formulation (expressed as a %).|Ratio - Test (Oral) / Reference (IV) (%)||||
71831716|NCT02507752|143167942|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in TJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71732917|NCT02715726|142981072|SUPERIORITY||LS mean difference|-35.6|||<|0.0001|TWO_SIDED|95.0|-40.6|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-30.7|-40.6|<0.0001
71732918|NCT02715726|142981073|SUPERIORITY||LS mean difference|-37.3|||<|0.0001|TWO_SIDED|95.0|-42.1|-32.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-32.6|-42.1|<0.0001
71732919|NCT02715726|142981074|SUPERIORITY||LS mean difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-39.5|-30.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.2|-39.5|<0.0001
71732920|NCT02715726|142981075|SUPERIORITY||LS mean difference|-35.4|||<|0.0001|TWO_SIDED|95.0|-40.0|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.7|-40.0|<0.0001
71732921|NCT02715726|142981076|SUPERIORITY|Threshold for significance at 0.05 level.|LS mean difference|-27.4|||<|0.0001|TWO_SIDED|95.0|-30.8|-23.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.9|-30.8|<0.0001
71732922|NCT02715726|142981077|SUPERIORITY||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.4|-31.2|<0.0001
71732923|NCT02715726|142981078|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-31.8|-23.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.6|-31.8|<0.0001
71831717|NCT02507752|143167943|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71732924|NCT02715726|142981079|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-32.6|-24.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.7|-32.6|<0.0001
71732925|NCT02715726|142981080|SUPERIORITY||LS mean difference|-20.2|||<|0.0001|TWO_SIDED|95.0|-23.1|-17.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.2|-23.1|<0.0001
71732926|NCT02715726|142981081|SUPERIORITY||LS mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-29.8|-23.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.2|-29.8|<0.0001
71732927|NCT02715726|142981082|SUPERIORITY||LS mean difference|-26.7|||<|0.0001|TWO_SIDED|95.0|-30.5|-22.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.8|-30.5|<0.0001
71732928|NCT02715726|142981083|SUPERIORITY||LS mean difference|-19.3|||<|0.0001|TWO_SIDED|95.0|-22.1|-16.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-16.5|-22.1|<0.0001
71732929|NCT02715726|142981084|SUPERIORITY||Odds Ratio (OR)|11.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||17.7|7.1|<0.0001
71732930|NCT02715726|142981085|SUPERIORITY||Odds Ratio (OR)|13.6|||<|0.0001|TWO_SIDED|95.0|8.3|22.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.3|8.3|<0.0001
71732931|NCT02715726|142981086|SUPERIORITY||Adjusted Mean Difference|-34.273|||<|0.0001|TWO_SIDED|95.0|-39.262|-29.285||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.285|-39.262|<0.0001
71732932|NCT02715726|142981087|SUPERIORITY||LS mean difference|1.9||||0.228|TWO_SIDED|95.0|-1.2|4.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.9|-1.2|0.2280
71732933|NCT03945019|142981137|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
71732934|NCT03945019|142981138|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.||||||<0.0001
71732935|NCT02598128|142981173|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).||||||<0.001
71732936|NCT01064687|142981187|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.22|-0.88||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.88|-1.22|<0.001
71732937|NCT01064687|142981187|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.66|<0.0001
71732938|NCT01064687|142981187|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.84|||<|0.001|TWO_SIDED|95.0|-1.01|-0.67||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.67|-1.01|<0.001
71772584|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.9704|TWO_SIDED|95.0|-2.61|2.51||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.51|-2.61|0.9704
71831718|NCT02507752|143167943|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in DAS28 at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71831719|NCT02507752|143167944|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71732939|NCT01064687|142981187|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.66|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.66|<0.001
71732940|NCT01064687|142981187|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.18|-0.44|<0.001
71732941|NCT01064687|142981187|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.18|-0.44|<0.001
71732942|NCT01064687|142981188|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.39|-0.73|<0.001
71732943|NCT01064687|142981188|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.||-0.11|-0.44|<0.001
71732944|NCT01064687|142981188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.39|-0.73|<0.001
71732945|NCT01064687|142981188|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.||-0.11|-0.44|<0.001
71732946|NCT01064687|142981189|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.72|||<|0.001|TWO_SIDED|95.0|-3.58|-1.85|||Mixed Models Analysis|||||-1.85|-3.58|<0.001
71732947|NCT01064687|142981189|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.571|TWO_SIDED|95.0|-0.88|0.49|||Mixed Models Analysis|||||0.49|-0.88|0.571
71732948|NCT01064687|142981189|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19||||0.007|TWO_SIDED|95.0|-2.06|-0.33|||Mixed Models Analysis|||||-0.33|-2.06|0.007
71732949|NCT01064687|142981189|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|||<|0.001|TWO_SIDED|95.0|0.64|2.01|||Mixed Models Analysis|||||2.01|0.64|<0.001
71732950|NCT01064687|142981189|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.52|||<|0.001|TWO_SIDED|95.0|-3.39|-1.65|||Mixed Models Analysis|||||-1.65|-3.39|<0.001
71732951|NCT01064687|142981190|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.507|TWO_SIDED|95.0|-1.25|0.62|||Mixed Models Analysis|||||0.62|-1.25|0.507
71732952|NCT01064687|142981190|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.009|TWO_SIDED|95.0|0.32|2.19|||Mixed Models Analysis|||||2.19|0.32|0.009
71732953|NCT01064687|142981191|SUPERIORITY_OR_OTHER||LS Means Difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.27|-0.67|||Mixed Models Analysis|||||-0.67|-1.27|<0.001
71732954|NCT01064687|142981191|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.568|TWO_SIDED|95.0|-0.31|0.17|||Mixed Models Analysis|||||0.17|-0.31|0.568
71732955|NCT01064687|142981191|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42||||0.006|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Models Analysis|||||-0.12|-0.72|0.006
71732956|NCT01064687|142981191|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|||<|0.001|TWO_SIDED|95.0|0.24|0.71|||Mixed Models Analysis|||||0.71|0.24|<0.001
71732957|NCT01064687|142981191|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||||-0.60|-1.20|<0.001
71732958|NCT01064687|142981192|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.58|TWO_SIDED|95.0|-0.42|0.23|||Mixed Models Analysis|||||0.23|-0.42|0.580
71831720|NCT02507752|143167944|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71732959|NCT01064687|142981192|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46||||0.005|TWO_SIDED|95.0|0.14|0.79|||Mixed Models Analysis|||||0.79|0.14|0.005
71732960|NCT01064687|142981193|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.76|||<|0.001|TWO_SIDED|95.0|-34.5|-23.02|||Mixed Models Analysis|||||-23.02|-34.50|<0.001
71732961|NCT01064687|142981193|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.34|||<|0.001|TWO_SIDED|95.0|-13.62|-5.06|||Mixed Models Analysis|||||-5.06|-13.62|<0.001
71732962|NCT01064687|142981193|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.02|||<|0.001|TWO_SIDED|95.0|-29.8|-18.24|||Mixed Models Analysis|||||-18.24|-29.80|<0.001
71732963|NCT01064687|142981193|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61||||0.038|TWO_SIDED|95.0|-8.95|-0.27|||Mixed Models Analysis|||||-0.27|-8.95|0.038
71732964|NCT01064687|142981193|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.41|||<|0.001|TWO_SIDED|95.0|-25.18|-13.65|||Mixed Models Analysis|||||-13.65|-25.18|<0.001
71732965|NCT01064687|142981194|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.68||||0.004|TWO_SIDED|95.0|-12.84|-2.52|||Mixed Models Analysis|||||-2.52|-12.84|0.004
71732966|NCT01064687|142981194|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.092|TWO_SIDED|95.0|-9.66|0.73|||Mixed Models Analysis|||||0.73|-9.66|0.092
71732967|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.1|||<|0.001|TWO_SIDED|95.0|7.4|23.4||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||23.4|7.4|<0.001
71732968|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|3.9|10.1||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||10.1|3.9|<0.001
71732969|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.001|TWO_SIDED|95.0|2.8|8.0||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||8.0|2.8|<0.001
71659402|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|2.29||||0.001|TWO_SIDED|95.0|0.91|3.67|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.67|0.91|0.001
71772585|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.7857|TWO_SIDED|95.0|-3.0|3.95||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||3.95|-3.00|0.7857
71831721|NCT02507752|143167945|SUPERIORITY_OR_OTHER||||||=|0.011|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.011
71659403|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|5.33|||<|0.001|TWO_SIDED|95.0|3.93|6.73|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.73|3.93|<0.001
71659404|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|8.48|||<|0.001|TWO_SIDED|95.0|6.51|10.44|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.44|6.51|<0.001
71659405|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|5.44|||<|0.001|TWO_SIDED|95.0|3.46|7.42|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.42|3.46|<0.001
71659406|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|3.04|||<|0.001|TWO_SIDED|95.0|1.65|4.43|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.43|1.65|<0.001
71659407|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|14.68|||<|0.001|TWO_SIDED|95.0|10.74|18.62|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.62|10.74|<0.001
71659408|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|3.16||||0.024|TWO_SIDED|95.0|0.41|5.91|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.91|0.41|0.024
71659409|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|7.94|||<|0.001|TWO_SIDED|95.0|5.15|10.73|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.73|5.15|<0.001
71659410|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|11.52|||<|0.001|TWO_SIDED|95.0|7.59|15.45|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||15.45|7.59|<0.001
71659411|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|6.75|||<|0.001||95.0|2.79|10.71|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||10.71|2.79|<0.001
71659412|NCT02912650|142833431|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|2.0|7.56|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.56|2.0|<0.001
71659413|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37|||<|0.001|TWO_SIDED|95.0|4.42|6.32|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.32|4.42|<0.001
71659414|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.002|TWO_SIDED|95.0|0.4|1.74|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.74|0.40|0.002
71659415|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|1.45|||<|0.001|TWO_SIDED|95.0|0.77|2.13|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||2.13|0.77|<0.001
71659416|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||<|0.001|TWO_SIDED|95.0|3.35|5.25|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.25|3.35|<0.001
71659417|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|||<|0.001|TWO_SIDED|95.0|2.96|4.88|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.88|2.96|<0.001
71659418|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.268|TWO_SIDED|95.0|-0.29|1.05|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||1.05|-0.29|0.268
71659419|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|17.99|||<|0.001|TWO_SIDED|95.0|14.69|21.28|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.28|14.69|<0.001
71659420|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|||<|0.001|TWO_SIDED|95.0|1.57|6.17|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.17|1.57|<0.001
71659421|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|8.81|||<|0.001|TWO_SIDED|95.0|6.48|11.15|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||11.15|6.48|<0.001
71659422|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|14.12|||<|0.001|TWO_SIDED|95.0|10.83|17.4|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.40|10.83|<0.001
71659423|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|9.17|||<|0.001|TWO_SIDED|95.0|5.86|12.48|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|5.86|<0.001
71659424|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|4.94|||<|0.001|TWO_SIDED|95.0|2.62|7.27|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||7.27|2.62|<0.001
71889176|NCT01583374|143299544|SUPERIORITY||LS Mean Difference|-0.09||||0.6262|TWO_SIDED|95.0|-0.45|0.27|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.27|-0.45|0.6262
71889177|NCT01583374|143299545|SUPERIORITY||Risk Difference (RD)|2.0||||0.6958|TWO_SIDED|95.0|-8.1|12.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||12.2|-8.1|0.6958
71889178|NCT01583374|143299545|SUPERIORITY||Risk Difference (RD)|4.4||||0.4051|TWO_SIDED|95.0|-5.8|14.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.|||14.5|-5.8|0.4051
71889179|NCT01583374|143299546|SUPERIORITY||LS Mean Difference|0.25||||0.5126|TWO_SIDED|95.0|-0.49|0.99|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.99|-0.49|0.5126
71732970|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.5|<0.001
71732971|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.004|TWO_SIDED|95.0|1.3|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||3.5|1.3|0.004
71732972|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.8|||<|0.001|TWO_SIDED|95.0|6.7|20.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||20.8|6.7|<0.001
71732973|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||6.8|2.9|<0.001
71732974|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||<|0.001|TWO_SIDED|95.0|3.7|10.9||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||10.9|3.7|<0.001
71732975|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.6|3.5||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.5|1.6|<0.001
71732976|NCT01064687|142981195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.6|4.6||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||4.6|1.6|<0.001
71732977|NCT01064687|142981196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|2.4|5.6||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||5.6|2.4|<0.001
71732978|NCT01064687|142981196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.008|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic|||||2.5|1.1|0.008
71732979|NCT01064687|142981196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.3|5.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||5.1|2.3|<0.001
71732980|NCT01064687|142981196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.4|3.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic|||||3.1|1.4|<0.001
71732981|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|35.21|||<|0.001|TWO_SIDED|95.0|27.26|43.16||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||43.16|27.26|<0.001
71732982|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|21.12|||<|0.001|TWO_SIDED|95.0|14.97|27.28||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||27.28|14.97|<0.001
71732983|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|22.68|||<|0.001|TWO_SIDED|95.0|14.63|30.72||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||30.72|14.63|<0.001
71732984|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|8.59||||0.007|TWO_SIDED|95.0|2.31|14.87||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||14.87|2.31|0.007
71732985|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|14.09|||<|0.001|TWO_SIDED|95.0|6.06|22.11||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||22.11|6.06|<0.001
71732986|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7||||0.207|TWO_SIDED|95.0|-14.56|3.17||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.17|-14.56|0.207
71732987|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.659|TWO_SIDED|95.0|-8.41|5.32||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.32|-8.41|0.659
71732988|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.759|TWO_SIDED|95.0|-10.37|7.56||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||7.56|-10.37|0.759
71732989|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|2.75||||0.441|TWO_SIDED|95.0|-4.25|9.76||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||9.76|-4.25|0.441
71732990|NCT01064687|142981197|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.15||||0.362|TWO_SIDED|95.0|-13.1|4.79||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||4.79|-13.10|0.362
71732991|NCT01064687|142981198|SUPERIORITY_OR_OTHER||LS Mean Difference|21.64|||<|0.001|TWO_SIDED|95.0|15.2|28.08||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||28.08|15.20|<0.001
71732992|NCT01064687|142981198|SUPERIORITY_OR_OTHER||LS Mean Difference|12.12|||<|0.001|TWO_SIDED|95.0|5.56|18.68||Treatment comparison of HOMA2-B|Mixed Models Analysis|||||18.68|5.56|<0.001
71889180|NCT01583374|143299546|SUPERIORITY||LS Mean Difference|0.28||||0.4624|TWO_SIDED|95.0|-0.46|1.01|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.01|-0.46|0.4624
71889181|NCT01583374|143299547|SUPERIORITY||LS Mean Difference|0.29||||0.6997|TWO_SIDED|95.0|-1.18|1.76|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.76|-1.18|0.6997
71889182|NCT01583374|143299547|SUPERIORITY||LS Mean Difference|-0.04||||0.9587|TWO_SIDED|95.0|-1.5|1.42|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||1.42|-1.50|0.9587
71889183|NCT01583374|143299548|SUPERIORITY||LS Mean Difference|0.06||||0.3307|TWO_SIDED|95.0|-0.06|0.17|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.17|-0.06|0.3307
71732993|NCT01064687|142981198|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73||||0.307|TWO_SIDED|95.0|-10.9|3.43||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||3.43|-10.90|0.307
71889184|NCT01583374|143299548|SUPERIORITY||LS Mean Difference|0.03||||0.5938|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.||||0.14|-0.08|0.5938
71732994|NCT01064687|142981198|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75||||0.638|TWO_SIDED|95.0|-9.05|5.55||Treatment comparison of HOMA2-S|Mixed Models Analysis|||||5.55|-9.05|0.638
71732995|NCT02299076|142981243|SUPERIORITY|Welch Two Sample t-test|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71732996|NCT00162266|142981245|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||||38.4|12.8|<0.001
71732997|NCT00162266|142981245|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31|TWO_SIDED|95.0|-6.2|19.4|||Chi-squared|||||19.4|-6.2|0.31
71732998|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.9||||0.283|TWO_SIDED|95.0|-4.9|16.7|||Chi-squared|||Response on Day 15||16.7|-4.9|0.283
71732999|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-11.6||||0.015|TWO_SIDED|95.0|-20.9|-2.3|||Chi-squared|||Response on Day 15||-2.3|-20.9|0.015
71772586|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.79||||0.1323|TWO_SIDED|95.0|-6.45|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-6.45|0.1323
71733000|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.5||||0.067|TWO_SIDED|95.0|-0.8|23.8|||Chi-squared|||Response on Day 30||23.8|-0.8|0.067
71733001|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-9.3||||0.113|TWO_SIDED|95.0|-20.8|2.2|||Chi-squared|||Response on Day 30||2.2|-20.8|0.113
71831722|NCT02507752|143167945|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Change in HAQ score from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
71733002|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|22.1|||<|0.001|TWO_SIDED|95.0|9.3|34.8|||Chi-squared|||Response on Day 60||34.8|9.3|<0.001
71733003|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.1||||0.86|TWO_SIDED|95.0|-13.5|11.3|||Chi-squared|||Response on Day 60||11.3|-13.5|0.86
71733004|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|18.6||||0.004|TWO_SIDED|95.0|5.9|31.4|||Chi-squared|||Response on Day 90||31.4|5.9|0.004
71733005|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.8||||0.664|TWO_SIDED|95.0|-9.8|15.4|||Chi-squared|||Response on Day 90||15.4|-9.8|0.664
71733006|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.9|||<|0.001|TWO_SIDED|95.0|11.1|36.7|||Chi-squared|||Response on Day 120||36.7|11.1|<0.001
71733007|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.9||||0.292|TWO_SIDED|95.0|-6.0|19.9|||Chi-squared|||Response on Day 120||19.9|-6.0|0.292
71733008|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|23.0|||<|0.001|TWO_SIDED|95.0|10.2|35.8|||Chi-squared|||Response on Day 150||35.8|10.2|<0.001
71733009|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.5||||0.193|TWO_SIDED|95.0|-4.3|21.3|||Chi-squared|||Response on Day 150||21.3|-4.3|0.193
71733010|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|25.6|||<|0.001|TWO_SIDED|95.0|12.8|38.4|||Chi-squared|||Response on Day 180||38.4|12.8|<0.001
71733011|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.31||95.0|-6.2|19.4|||Chi-squared|||Response on Day 180||19.4|-6.2|0.31
71733012|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|27.3|||<|0.001|TWO_SIDED|95.0|14.5|40.1|||Chi-squared|||Response on Day 240||40.1|14.5|<0.001
71733013|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.7||||0.384|TWO_SIDED|95.0|-7.1|18.4|||Chi-squared|||Response on Day 240||18.4|-7.1|0.384
71733014|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|29.0|||<|0.001|TWO_SIDED|95.0|16.2|41.8|||Chi-squared|||Response on Day 300||41.8|16.2|<0.001
71733015|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.6||||0.476|TWO_SIDED|95.0|-8.0|17.2|||Chi-squared|||Response on Day 300||17.2|-8.0|0.476
71733016|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|26.5|||<|0.001|TWO_SIDED|95.0|13.7|39.3|||Chi-squared|||Response on Day 360||39.3|13.7|<0.001
71733017|NCT00162266|142981246|SUPERIORITY_OR_OTHER||Point Estimate of Difference|5.8||||0.377|TWO_SIDED|95.0|-7.0|18.6|||Chi-squared|||Response on Day 360||18.6|-7.0|0.377
71733018|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-0.8||||0.679|TWO_SIDED|95.0|-4.5|2.9|||Chi-squared|||Response on Day 15||2.9|-4.5|0.679
71733019|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.5||||0.101|TWO_SIDED|95.0|-5.5|0.5|||Chi-squared|||Response on Day 15||0.5|-5.5|0.101
71733020|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.039|TWO_SIDED|95.0|0.4|15.7|||Chi-squared|||Response on Day 30||15.7|0.4|0.039
71733021|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-2.1||||0.474|TWO_SIDED|95.0|-7.7|3.6|||Chi-squared|||Response on Day 30||3.6|-7.7|0.474
71831723|NCT02507752|143167946|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71831724|NCT02507752|143167946|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change in pain scale from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71733022|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.6||||0.192|TWO_SIDED|95.0|-3.3|16.5|||Chi-squared|||Response on Day 60||16.5|-3.3|0.192
71733023|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|-1.8||||0.702|TWO_SIDED|95.0|-11.0|7.4|||Chi-squared|||Response on Day 60||7.4|-11.0|0.702
71733024|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.7||||0.02|TWO_SIDED|95.0|1.8|21.7|||Chi-squared|||Response on Day 90||21.7|1.8|0.02
71733025|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.5||||0.339|TWO_SIDED|95.0|-4.8|13.8|||Chi-squared|||Response on Day 90||13.8|-4.8|0.339
71733026|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|17.9||||0.001|TWO_SIDED|95.0|7.0|28.9|||Chi-squared|||Response on Day 120||28.9|7.0|0.001
71733027|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.0||||0.682|TWO_SIDED|95.0|-7.6|11.7|||Chi-squared|||Response on Day 120||11.7|-7.6|0.682
71733028|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|20.6|||<|0.001|TWO_SIDED|95.0|9.3|31.8|||Chi-squared|||Response on Day 150||31.8|9.3|<0.001
71733029|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|1.2||||0.813|TWO_SIDED|95.0|-8.6|10.9|||Chi-squared|||Response on Day 150||10.9|-8.6|0.813
71733030|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.8|||<|0.001|TWO_SIDED|95.0|13.8|35.7|||Chi-squared|||Response on Day 180||35.7|13.8|<0.001
71772587|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.4618|TWO_SIDED|95.0|-4.29|1.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.97|-4.29|0.4618
71831725|NCT02507752|143167947|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Physical component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
71831726|NCT02507752|143167947|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||ANOVA|||Mental component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.001
71831727|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.102|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.102
71831728|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Physical functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
71831729|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||ANOVA|||Role physical domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.008
71831730|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Role physical domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71831731|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
71831732|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Bodily pain domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||< 0.001
71733031|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|11.1||||0.027|TWO_SIDED|95.0|1.2|20.9|||Chi-squared|||Response on Day 180||20.9|1.2|0.027
71733032|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|15.5||||0.008|TWO_SIDED|95.0|4.0|27.0|||Chi-squared|||Response on Day 240||27.0|4.0|0.008
71733033|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|0.8||||0.885|TWO_SIDED|95.0|-9.8|11.4|||Chi-squared|||Response on Day 240||11.4|-9.8|0.885
71733034|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|24.0|||<|0.001|TWO_SIDED|95.0|12.6|35.4|||Chi-squared|||Response on Day 300||35.4|12.6|<0.001
71733035|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|6.8||||0.19|TWO_SIDED|95.0|-3.4|16.9|||Chi-squared|||Response on Day 300||16.9|-3.4|0.19
71733036|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.6|||<|0.001|TWO_SIDED|95.0|9.7|33.4|||Chi-squared|||Response on Day 360||33.4|9.7|<0.001
71733037|NCT00162266|142981247|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.7||||0.625|TWO_SIDED|95.0|-8.1|13.5|||Chi-squared|||Response on Day 360||13.5|-8.1|0.625
71733038|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.04||95.0|0.2|6.8|||Chi-squared|||Response on Day 30||6.8|0.2|0.04
71733039|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.9||||0.063|TWO_SIDED|95.0|-0.2|5.9|||Chi-squared|||Response on Day 30||5.9|-0.2|0.063
71733040|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.7||||0.001|TWO_SIDED|95.0|3.5|13.9|||Chi-squared|||Response on Day 60||13.9|3.5|0.001
71733041|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.8||||0.032|TWO_SIDED|95.0|0.3|7.3|||Chi-squared|||Response on Day 60||7.3|0.3|0.032
71733042|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|7.9||||0.005|TWO_SIDED|95.0|2.4|13.3|||Chi-squared|||Response on Day 90||13.3|2.4|0.005
71733043|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.9||||0.07|TWO_SIDED|95.0|-0.3|8.2|||Chi-squared|||Response on Day 90||8.2|-0.3|0.07
71733044|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|9.7||||0.007|TWO_SIDED|95.0|2.7|16.7|||Chi-squared|||Response on Day 120||16.7|2.7|0.007
71733045|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395||95.0|-3.1|7.8|||Chi-squared|||||7.8|-3.1|0.395
71659425|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|21.94|||<|0.001|TWO_SIDED|95.0|17.52|26.37|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.37|17.52|<0.001
71659426|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.002|TWO_SIDED|95.0|1.91|8.09|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.09|1.91|0.002
71733046|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|10.6||||0.004|TWO_SIDED|95.0|3.4|17.7|||Chi-squared|||Response on Day 150||17.7|3.4|0.004
71733047|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|2.4||||0.395|TWO_SIDED|95.0|-3.1|7.8|||Chi-squared|||Response on Day 150||7.8|-3.1|0.395
71733048|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.2|||Chi-squared|||Response on Day 180||22.2|7.5|<0.001
71733049|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.8||||0.005|TWO_SIDED|95.0|2.7|14.9|||Chi-squared|||Response on Day 180||14.9|2.7|0.005
71733050|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||Chi-squared|||Response on Day 240||21.4|5.0|0.002
71733051|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|3.5||||0.292|TWO_SIDED|95.0|-3.0|10.1|||Chi-squared|||Response on Day 240||10.1|-3.0|0.292
71733052|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|21.0|||<|0.001|TWO_SIDED|95.0|12.4|29.5|||Chi-squared|||Response on Day 300||29.5|12.4|<0.001
71733053|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|8.0||||0.014|TWO_SIDED|95.0|1.6|14.3|||Chi-squared|||Response on Day 300||14.3|1.6|0.014
71772588|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.2622|TWO_SIDED|95.0|-1.74|6.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||6.22|-1.74|0.2622
71831733|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.077|TWO_SIDED||||||ANOVA|||General health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.077
71831734|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||ANOVA|||General health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.068
71831735|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.018|TWO_SIDED||||||ANOVA|||Vitality domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.018
71733054|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|13.3||||0.003|TWO_SIDED|95.0|4.4|22.2|||Chi-squared|||Response on Day 360||22.2|4.4|0.003
71733055|NCT00162266|142981248|SUPERIORITY_OR_OTHER||Point Estimate of Difference|4.8||||0.227|TWO_SIDED|95.0|-3.0|12.6|||Chi-squared|||Response on Day 360||12.6|-3.0|0.227
71733056|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.2676|TWO_SIDED|95.0|-1.56|5.61|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||5.61|-1.56|0.2676
71733057|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.0418|TWO_SIDED|95.0|-7.46|-0.14|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison||-0.14|-7.46|0.0418
71831736|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.053|TWO_SIDED||||||ANOVA|||Vitality domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.053
71831737|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.002
71659427|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|11.43|||<|0.001|TWO_SIDED|95.0|8.29|14.56|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.56|8.29|<0.001
71659428|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|16.94|||<|0.001|TWO_SIDED|95.0|12.53|21.36|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||21.36|12.53|<0.001
71659429|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|10.52|||<|0.001|TWO_SIDED|95.0|6.07|14.97|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||14.97|6.07|<0.001
71733058|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.25||||0.0061|TWO_SIDED|95.0|2.08|12.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||12.41|2.08|0.0061
71733059|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.6713|TWO_SIDED|95.0|-6.45|4.16||ANOVA model: AUC = treatment|ANOVA||Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison||4.16|-6.45|0.6713
71733060|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.75||||0.0002|TWO_SIDED|95.0|5.67|17.84|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||17.84|5.67|0.0002
71733061|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.8495|TWO_SIDED|95.0|-5.62|6.82|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison||6.82|-5.62|0.8495
71733062|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1||||0.0003|TWO_SIDED|95.0|5.63|18.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||18.56|5.63|0.0003
71733063|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0003|TWO_SIDED|95.0|-2.44|10.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison||10.81|-2.44|0.0003
71733064|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.54||||0.0001|TWO_SIDED|95.0|7.28|21.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||21.81|7.28|0.0001
71733065|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.3141|TWO_SIDED|95.0|-3.43|10.64|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison||10.64|-3.43|0.3141
71733066|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96||||0.0001|TWO_SIDED|95.0|8.49|25.43|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||25.43|8.49|0.0001
71733067|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.32||||0.3552|TWO_SIDED|95.0|-3.73|10.37|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison||10.37|-3.73|0.3552
71772589|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.4499|TWO_SIDED|95.0|-5.64|2.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.55|-5.64|0.4499
71772590|NCT01227564|143045004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.8454|TWO_SIDED|95.0|-3.21|3.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.91|-3.21|0.8454
71772591|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.1796|TWO_SIDED|95.0|-0.18|0.96||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.96|-0.18|0.1796
71831738|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||ANOVA|||Social functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.003
71831739|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.015
71831740|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.154|TWO_SIDED||||||ANOVA|||Role emotional domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.154
71831741|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.024|TWO_SIDED||||||ANOVA|||Mental health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.024
71831742|NCT02507752|143167948|SUPERIORITY_OR_OTHER||||||=|0.029|TWO_SIDED||||||ANOVA|||Mental health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)||||= 0.029
71831743|NCT01061151|143167952|SUPERIORITY||Risk Difference (RD)|-1.3|||||TWO_SIDED|96.5|-2.1|-0.4|||||The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan-DeMets approach with an O'Brien-Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).|Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.||-0.4|-2.1|
71831744|NCT01061151|143167953|SUPERIORITY|||||||0.008|||||||Fisher Exact|||Periods 1 and 2||||0.008
71831745|NCT01061151|143167953|SUPERIORITY|||||||0.77|||||||Fisher Exact|||Period 2||||0.77
71733068|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.36||||0.0001|TWO_SIDED|95.0|10.19|30.54|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||30.54|10.19|0.0001
71733069|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38||||0.0451|TWO_SIDED|95.0|0.16|14.6|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison||14.60|0.16|0.0451
71733070|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.63||||0.0001|TWO_SIDED|95.0|8.83|26.44|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||26.44|8.83|0.0001
71831746|NCT01061151|143167953|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Period 2||||>0.99
71831747|NCT01061151|143167954|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Periods 1 and 2||||0.30
71831748|NCT01061151|143167954|SUPERIORITY|||||||0.64|||||||Fisher Exact|||Period 2||||0.64
71831749|NCT01061151|143167954|SUPERIORITY|||||||0.06|||||||Fisher Exact|||Period 2||||0.06
71831750|NCT01061151|143167955|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Periods 1 and 2||||<0.001
71831751|NCT01061151|143167955|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Period 2||||0.04
71831752|NCT01061151|143167955|SUPERIORITY|||||||0.46|||||||Fisher Exact|||Period 2||||0.46
71659430|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|6.43|||<|0.001|TWO_SIDED|95.0|3.3|9.55|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.55|3.30|<0.001
71659431|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|||<|0.001|TWO_SIDED|95.0|18.57|31.63|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||31.63|18.57|<0.001
71659432|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.023|TWO_SIDED|95.0|0.74|9.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||9.86|0.74|0.023
71733071|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78||||0.4669|TWO_SIDED|95.0|-4.73|10.28|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison||10.28|-4.73|0.4669
71733072|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.0001|TWO_SIDED|95.0|10.51|31.48|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||31.48|10.51|0.0001
71733073|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13||||3.13|TWO_SIDED|95.0|-4.15|10.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison||10.41|-4.15|3.13
71733074|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38||||0.0001|TWO_SIDED|95.0|10.2|30.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||30.56|10.20|0.0001
71733075|NCT00162266|142981249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.06||||0.2989|TWO_SIDED|95.0|-3.61|11.72|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison||11.72|-3.61|0.2989
71733076|NCT00162266|142981250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2132.63||||0.0001|TWO_SIDED|95.0|1067.32|3197.94||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||3197.94|1067.32|0.0001
71733077|NCT00162266|142981250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|353.47||||0.4393|TWO_SIDED|95.0|-544.46|1251.41||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180||1251.41|-544.46|0.4393
71772592|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.7281|TWO_SIDED|95.0|-0.49|0.69||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.69|-0.49|0.7281
71733078|NCT00162266|142981250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5641.6||||0.0001|TWO_SIDED|95.0|2823.46|8459.74||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||8459.74|2823.46|0.0001
71733079|NCT00162266|142981250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1054.38||||0.3029|TWO_SIDED|95.0|-955.59|3064.35||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360||3064.35|-955.59|0.3029
71733080|NCT00162266|142981254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.66||||0.0003|TWO_SIDED|95.0|12.67|42.66|||ANCOVA|ANCOVA: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||42.66|12.67|0.0003
71733081|NCT00162266|142981254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.68||||0.3253|TWO_SIDED|95.0|||||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180||||0.3253
71733082|NCT00162266|142981254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.24||||0.0001|TWO_SIDED|95.0|16.14|48.33|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||48.33|16.14|0.0001
71733083|NCT00162266|142981254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48||||0.0869|TWO_SIDED|95.0|-1.82|26.78|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360||26.78|-1.82|0.0869
71831753|NCT01061151|143167956|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|96.0|0.3|3.1|||||The confidence interval was based on a repeated confidence interval.|||3.1|0.3|
71831754|NCT01061151|143167957|SUPERIORITY|||||||0.98|||||||Log Rank|||||||0.98
71659433|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|13.17|||<|0.001|TWO_SIDED|95.0|8.55|17.8|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||17.80|8.55|<0.001
71659434|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.28|26.31|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||26.31|13.28|<0.001
71659435|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|11.93|||<|0.001|TWO_SIDED|95.0|5.36|18.49|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||18.49|5.36|<0.001
71659436|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|7.87|||<|0.001|TWO_SIDED|95.0|3.27|12.48|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||12.48|3.27|<0.001
71659437|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|6.61|||<|0.001|TWO_SIDED|95.0|4.61|8.62|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||8.62|4.61|<0.001
71659438|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|1.74||||0.015|TWO_SIDED|95.0|0.34|3.14|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||3.14|0.34|0.015
71659439|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|2.92|5.76|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||5.76|2.92|<0.001
71659440|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|4.87|||<|0.001|TWO_SIDED|95.0|2.87|6.88|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||6.88|2.87|<0.001
71659441|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|2.27||||0.028|TWO_SIDED|95.0|0.25|4.28|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.28|0.25|0.028
71733084|NCT01969721|142981313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.103|0.147||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.147|0.103|<0.0001
71733085|NCT01969721|142981313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.129|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.107|0.15||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.150|0.107|<0.0001
71733086|NCT01969721|142981313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001||95.0|0.081|0.124||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.124|0.081|<0.0001
71733087|NCT01969721|142981313|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.085|0.128||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."||0.128|0.085|<0.0001
71739364|NCT00475904|142991606|NON_INFERIORITY_OR_EQUIVALENCE|To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.2311||0.8409|TWO_SIDED|90.0|-0.33|0.43||To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|ANCOVA|||the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.||0.43|-0.33|0.8409
71831755|NCT01061151|143167958|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.37|TWO_SIDED|95.0|0.14|2.08|||Log Rank||The hazard ratio compares Arm A relative to Arm B.|||2.08|0.14|0.37
71831756|NCT01061151|143167960|SUPERIORITY|||||||0.16|||||||Two-sided Z test|||Overall survival||||0.16
71831757|NCT01061151|143167960|SUPERIORITY|||||||0.0156|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0156
71831758|NCT01061151|143167960|SUPERIORITY|||||||0.31|||||||Two-sided Z test|||Overall survival, period 2 group||||0.31
71659442|NCT02912650|142833432|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|||<|0.001|TWO_SIDED|95.0|1.19|4.02|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.||4.02|1.19|<0.001
71831759|NCT01061151|143167960|SUPERIORITY|||||||0.0022|||||||Two-sided Z test|||Overall survival, period 2 group||||0.0022
71831760|NCT01061151|143167960|SUPERIORITY|||||||0.13|||||||Two-sided Z test|||HIV-free survival||||0.13
71659443|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.56|||<|0.001|TWO_SIDED|95.0|-49.41|-23.71|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.71|-49.41|<0.001
71659444|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.95||||0.086|TWO_SIDED|95.0|-8.45|0.56|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.56|-8.45|0.086
71659445|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.71||||0.112|TWO_SIDED|95.0|-8.28|0.86|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.86|-8.28|0.112
71733088|NCT01969721|142981314|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.061|0.103||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.103|0.061|<0.0001
71733089|NCT01969721|142981314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.065|0.107||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.107|0.065|<0.0001
71733090|NCT01969721|142981314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.045|0.086||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.086|0.045|<0.0001
71733091|NCT01969721|142981314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|0.048|0.09||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.090|0.048|<0.0001
71739365|NCT03422536|142991612|EQUIVALENCE|The pre-specified significance criteria were met by exclusion of the historical control PFS of 2.0 months. As confirmation, the one-sample log rank test was computed with expected survival estimated using an exponential distribution of 2.0 months.||||||0.04||||||The a priori threshold for statistical significance is \<.05|Log Rank|||||||.04
71739366|NCT03422536|142991617|SUPERIORITY|||||||0.005|||||||Regression, Cox|||c-Met positivity was compared across groups: HPV+ vs HPV-||||.005
71739367|NCT03422536|142991617|SUPERIORITY||Cox Proportional Hazard|0.3||||0.02|TWO_SIDED|95.0|0.1|0.8|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in cMet positive vs. c-Met negative patients.||0.8|0.1|.02
71772593|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.3347|TWO_SIDED|95.0|-0.26|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.75|-0.26|0.3347
71772594|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.3425|TWO_SIDED|95.0|-0.43|1.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.20|-0.43|0.3425
71831761|NCT01061151|143167960|SUPERIORITY|||||||0.44|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.44
71831762|NCT01061151|143167960|SUPERIORITY|||||||0.24|||||||Two-sided Z test|||HIV-free survival, period 2 group||||0.24
71831763|NCT01061151|143167960|SUPERIORITY|||||||0.26|||||||Two-sided Z test|||HIV-free survival, group 2||||0.26
71831764|NCT03740009|143167989|NON_INFERIORITY|For analyses the researchers used a paired T-test to compare baseline and post-treatment mean activation values across 3 regions of interest (ROIs): the caudate, putamen and nucleus accumbens.||||||0.53|||||||t-test, 2 sided|||\[Ho\]: TSEC has no meaningful effect on activity within key nodes of the frontostriate in response to reward.||||0.53
71733092|NCT01969721|142981315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.071|0.022|0.0002
71733093|NCT01969721|142981315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.082|0.034|<0.0001
71733094|NCT01969721|142981315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.018|0.067||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.067|0.018|0.0007
71733095|NCT01969721|142981315|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.029|0.078||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.078|0.029|<0.0001
71733096|NCT01969721|142981316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.012||0.0007|TWO_SIDED|95.0|0.017|0.062||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.062|0.017|0.0007
71733097|NCT01969721|142981316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.043|STANDARD_ERROR_OF_MEAN|0.011||0.0002|TWO_SIDED|95.0|0.021|0.065||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.065|0.021|0.0002
71739233|NCT02218008|142991199|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.018|TWO_SIDED|95.0|-2.7|-0.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.3|-2.7|0.018
71831765|NCT03740009|143167990|NON_INFERIORITY|Analysis included MASQ-AD scores from all visits to characterize the change in scores from baseline to post-treatment.|GLM|-5.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|||||Mixed models of 3 week TSEC administration for MASQ-AD scores assessed at each study visit from baseline to post-treatment.|GLM||F value=13.26|\[Ho\] No change in depressive symptoms from baseline throughout 3 weeks of TSEC administration||||<0.001
71831766|NCT03926039|143167991|EQUIVALENCE|Equivalence Analysis||||||0.05|||||||ANOVA|||Both group of average difference (95% CI) in intervention group and control group||||0.05
71659446|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.52|||<|0.001|TWO_SIDED|95.0|-45.86|-19.17|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.17|-45.86|<0.001
71733098|NCT01969721|142981316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028|STANDARD_ERROR_OF_MEAN|0.011||0.0146|TWO_SIDED|95.0|0.006|0.051||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.051|0.006|0.0146
71733099|NCT01969721|142981316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.011||0.0055|TWO_SIDED|95.0|0.009|0.054||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.054|0.009|0.0055
71733100|NCT01969721|142981317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.118|0.166||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.166|0.118|<0.0001
71733101|NCT01969721|142981317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.123|0.171||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.171|0.123|<0.0001
71733102|NCT01969721|142981317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.135|0.087|<0.0001
71733103|NCT01969721|142981317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.092|0.14||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0-3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.||0.140|0.092|<0.0001
71733104|NCT02117349|142981343|OTHER||Odds Ratio (OR)|42.8|||=|0.001|TWO_SIDED|95.0|4.58|401.0||Study was terminated early at 55 randomized subjects, therefore p-value is considered nominal|Regression, Logistic|||Odds Ratio (OR) and Wald-based 95% Confidence intervals (CIs) are from logistic regression model comparing the response between treatment arms.||401.0|4.58|= 0.0010
71733105|NCT02265796|142981346|SUPERIORITY||||||>|0.05||||||the reported p value is for all between group comparisons of the SAQ domains.|t-test, 2 sided|||between group comparison for all SAQ domains||||>0.05
71733106|NCT02265796|142981346|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation, angina frequency and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
71659447|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-32.88|||<|0.001|TWO_SIDED|95.0|-46.22|-19.55|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.55|-46.22|<0.001
71733107|NCT02265796|142981346|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
71733108|NCT02265796|142981346|SUPERIORITY||||||>|0.05||||||reported p value is for the physical limitation and treatment satisfaction domains|paired t test|||within group comparison of change from baseline||||>0.05
71733109|NCT02265796|142981346|SUPERIORITY||||||<|0.05||||||reported p value is for the angina stability, angina frequency and quality of life domains|paired t test|||within group comparison of change from baseline||||<0.05
71659448|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|0.11||||0.968|TWO_SIDED|95.0|-5.2|5.42|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.42|-5.20|0.968
71659449|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.88|||<|0.001|TWO_SIDED|95.0|-61.18|-34.58|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-34.58|-61.18|<0.001
71659450|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.023|TWO_SIDED|95.0|-11.61|-0.84|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.84|-11.61|0.023
71659451|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.23||||0.026|TWO_SIDED|95.0|-11.73|-0.73|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.73|-11.73|0.026
71733110|NCT02265796|142981347|SUPERIORITY|||||||0.58|||||||Fisher Exact|||"between group comparison for the excellent/good"||||0.58
71659452|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.51|||<|0.001|TWO_SIDED|95.0|-55.51|-27.52|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.52|-55.51|<0.001
71659453|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-41.77|||<|0.001|TWO_SIDED|95.0|-55.65|-27.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-27.89|-55.65|<0.001
71733111|NCT02265796|142981347|SUPERIORITY|||||||0.8|||||||Fisher Exact|||"Between group analysis for fair/poor"||||0.80
71733112|NCT02265796|142981347|SUPERIORITY|||||||0.5|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.50
71733113|NCT02265796|142981347|SUPERIORITY|||||||0.48|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.48
71733114|NCT02265796|142981347|SUPERIORITY|||||||0.19|||||||McNemar|||within group analysis of change from baseline for excellent/good||||0.19
71733115|NCT02265796|142981347|SUPERIORITY|||||||0.067|||||||McNemar|||within group comparison of change from baseline for fair/poor||||0.067
71733116|NCT02265796|142981348|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71733117|NCT02963701|142981357|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|99.16|STANDARD_DEVIATION|8.49|||TWO_SIDED|90.0|96.52|101.89|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.89|96.52|
71739368|NCT03422536|142991617|SUPERIORITY||Cox Proportional Hazard|0.1||||0.03|TWO_SIDED|95.0|0.03|0.8|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV- patients in the combination arm.||0.8|0.03|0.03
71739369|NCT03422536|142991617|SUPERIORITY||Cox Proportional Hazard|3.2||||0.2|TWO_SIDED|95.0|0.6|17.5|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at cMet positivity in HPV+ patients in the combination arm.||17.5|0.6|.20
71739370|NCT03422536|142991617|SUPERIORITY||Cox Proportional Hazard|1.4||||0.1|TWO_SIDED|95.0|0.9|2.0|||Log Rank|||Post-hoc comparison of progression free survival (PFS) in HGF positive vs. HGF negative patients.||2.0|0.9|.10
71739371|NCT03422536|142991617|SUPERIORITY||Cox Proportional Hazard|1.4||||0.6|TWO_SIDED|95.0|0.4|4.7|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P , .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV- patients in the combination arm.||4.7|0.4|.60
71739372|NCT03422536|142991617|SUPERIORITY||Cox Proportional Hazard|3.4||||0.07|TWO_SIDED|95.0|0.9|13.1|||Log Rank|||Post hoc comparison of PFS in the combination arm by HPV subgroup, adjusted for prognostic factors marginally associated with HPV status (P \< .10), was assessed using Cox proportional hazards models. Here we are looking at HGF expression in HPV+ patients in the combination arm.||13.1|0.9|.07
71739373|NCT04929249|142991624|SUPERIORITY||LS mean difference|-53.0|||<|0.001|TWO_SIDED|97.5|-60.0|-46.0|||Mixed Models Analysis|||||-46.0|-60.0|<0.001
71739374|NCT04929249|142991625|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the one-sided 98.75% confidence interval did not exceed the non-inferiority margin of 15%.|Difference in percentage|-10.6|||||TWO_SIDED|97.5|-18.3|-3.0|||Normal approx. to binomial distribution||||Upper limit of one-sided 98.75% CI (-3.0%)|-3.0|-18.3|
71739375|NCT04929249|142991626|SUPERIORITY||LS mean difference|-47.6|||<|0.001|TWO_SIDED|95.0|-52.8|-42.3|||Mixed Models Analysis|||||-42.3|-52.8|<0.001
71739376|NCT04929249|142991627|SUPERIORITY||LS mean difference|-54.4|||<|0.001|TWO_SIDED|95.0|-59.0|-49.8|||Regression, Linear|||||-49.8|-59.0|<0.001
71739377|NCT04929249|142991628|SUPERIORITY||LS mean difference|-48.9|||<|0.001|TWO_SIDED|95.0|-52.9|-44.9|||Regression, Linear|||||-44.9|-52.9|<0.001
71831767|NCT03752151|143168033|SUPERIORITY||||||<|0.001|||||||McNemar|||The null hypothesis was that the probability of meeting the endpoint (Atrioventricular synchrony \>70%) was the same in MARVEL 2 Monitor Mode and MARVEL 2 Adaptive Mode. A sample size of 35 participants with a predominant rhythm of 3rd degree atrioventricular block and normal sinus function provided \>90% power at a type I error rate of 0.05 assuming the proportion of patients meeting the endpoint in one mode, but not the other exceeded 50% and 90% of these pairs favored the Adaptive mode.||||<0.001
71831768|NCT03752151|143168034|SUPERIORITY||proportion expressed as a percentage|100.0|||<|0.001|TWO_SIDED|95.0|95.2|100.0|||Exact binomial test|||The null hypothesis is that 87% or fewer participants will achieve the endpoint. The alternative hypothesis is that more than 87% of participants will achieve the endpoint. A sample size of 70 participants provides at least 90% power to test the null hypothesis assuming the true rate of meeting the endpoint in the population is 98% at a type I error rate of 2.5%.||100|95.2|<0.001
71659454|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.16||||0.96|TWO_SIDED|95.0|-6.56|6.23|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.23|-6.56|0.960
71659455|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-55.73|||<|0.001|TWO_SIDED|95.0|-68.81|-42.65|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-42.65|-68.81|<0.001
71659456|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.16||||0.055|TWO_SIDED|95.0|-12.46|0.13|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.13|-12.46|0.055
71659457|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.7||||0.001|TWO_SIDED|95.0|-18.7|-4.7|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.70|-18.70|0.001
71659458|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-49.41|||<|0.001|TWO_SIDED|95.0|-63.21|-35.6|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-35.60|-63.21|<0.001
71659459|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-44.3|||<|0.001|TWO_SIDED|95.0|-58.04|-30.55|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-30.55|-58.04|<0.001
71659460|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.69||||0.151|TWO_SIDED|95.0|-13.46|2.08|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.08|-13.46|0.151
71659461|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-56.94|||<|0.001|TWO_SIDED|95.0|-69.96|-43.91|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-43.91|-69.96|<0.001
71659462|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-9.0||||0.01|TWO_SIDED|95.0|-15.8|-2.19|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.19|-15.80|0.010
71659463|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.11|||<|0.001|TWO_SIDED|95.0|-27.97|-12.24|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.24|-27.97|<0.001
71659464|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.73|||<|0.001|TWO_SIDED|95.0|-61.64|-33.83|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.83|-61.64|<0.001
71659465|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-37.18|||<|0.001|TWO_SIDED|95.0|-50.96|-23.4|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-23.40|-50.96|<0.001
71659466|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.19||||0.013|TWO_SIDED|95.0|-20.02|-2.36|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.36|-20.02|0.013
71659467|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-58.14|||<|0.001|TWO_SIDED|95.0|-71.03|-45.26|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-45.26|-71.03|<0.001
71739378|NCT04929249|142991629|SUPERIORITY||Odds Ratio (OR)|42.32|||<|0.001|TWO_SIDED|95.0|22.07|81.16|||Regression, Logistic|||||81.16|22.07|<0.001
71739379|NCT04929249|142991630|SUPERIORITY||Odds Ratio (OR)|17.32|||<|0.001|TWO_SIDED|95.0|6.72|44.66|||Regression, Logistic|||||44.66|6.72|<0.001
71739380|NCT04929249|142991631|SUPERIORITY||Odds Ratio (OR)|24.46|||<|0.001|TWO_SIDED|95.0|14.18|42.19|||Regression, Logistic|||||42.19|14.18|<0.001
71739381|NCT04929249|142991632|SUPERIORITY||Odds Ratio (OR)|35.12|||<|0.001|TWO_SIDED|95.0|19.51|63.24|||Regression, Logistic|||||63.24|19.51|<0.001
71739382|NCT04929249|142991633|SUPERIORITY||LS mean difference|-30.1|||<|0.001|TWO_SIDED|95.0|-33.8|-26.3|||Mixed Models Analysis|||Total Cholesterol||-26.3|-33.8|<0.001
71739383|NCT04929249|142991633|SUPERIORITY||LS mean difference|6.6|||<|0.001|TWO_SIDED|95.0|3.6|9.5|||Mixed Models Analysis|||HDL Cholesterol||9.5|3.6|<0.001
71733118|NCT02963701|142981358|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|89.16|STANDARD_DEVIATION|19.28|||TWO_SIDED|90.0|83.88|94.76|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||94.76|83.88|
71733119|NCT02963701|142981359|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.75|STANDARD_DEVIATION|12.96|||TWO_SIDED|90.0|95.73|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation \[%\].|||103.95|95.73|
71733120|NCT02963701|142981360|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|102.16|STANDARD_DEVIATION|15.37|||TWO_SIDED|90.0|97.3|107.27|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios \[%\] of Test and Reference products. The parameter dispersion type \[SD\] was actually the intra-individual geometric coefficient of variation \[%\].|||107.27|97.30|
71733121|NCT02963701|142981361|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|98.97|STANDARD_DEVIATION|8.13|||TWO_SIDED|90.0|96.44|101.57|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%)of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||101.57|96.44|
71733122|NCT02963701|142981362|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.67|STANDARD_DEVIATION|13.5|||TWO_SIDED|90.0|95.48|104.04|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.04|95.48|
71733123|NCT02963701|142981363|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|95.96|STANDARD_DEVIATION|14.27|||TWO_SIDED|90.0|91.7|100.4|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.40|91.70|
71739384|NCT04929249|142991633|SUPERIORITY||LS mean difference|-44.2|||<|0.001|TWO_SIDED|95.0|-49.1|-39.3|||Mixed Models Analysis|||Non-HDL Cholesterol||-39.3|-49.1|<0.001
71739385|NCT04929249|142991633|SUPERIORITY||LS mean difference|-16.9|||<|0.001|TWO_SIDED|95.0|-23.8|-10.0|||Mixed Models Analysis|||VLDL Cholesterol||-10.0|-23.8|<0.001
71739386|NCT04929249|142991633|SUPERIORITY||LS mean difference|-17.8|||<|0.001|TWO_SIDED|95.0|-24.7|-10.9|||Mixed Models Analysis|||Triglycerides||-10.9|-24.7|<0.001
71739387|NCT04929249|142991633|SUPERIORITY||LS mean difference|-42.6|||<|0.001|TWO_SIDED|95.0|-47.5|-37.8|||Mixed Models Analysis|||Apolipoprotein B||-37.8|-47.5|<0.001
71739388|NCT04929249|142991633|SUPERIORITY||LS mean difference|-21.9|||<|0.001|TWO_SIDED|95.0|-25.8|-18.0|||Mixed Models Analysis|||Lipoprotein(a)||-18.0|-25.8|<0.001
71739389|NCT04929249|142991634|SUPERIORITY||LS mean difference|-49.9|||<|0.001|TWO_SIDED|95.0|-56.0|-43.9|||Mixed Models Analysis|||Total Cholesterol||-43.9|-56.0|<0.001
71661203|NCT00123474|142836041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
71739390|NCT04929249|142991634|SUPERIORITY||LS mean difference|3.1|||<|0.001|TWO_SIDED|95.0|1.8|4.4|||Mixed Models Analysis|||HDL Cholesterol||4.4|1.8|<0.001
71739391|NCT04929249|142991634|SUPERIORITY||LS mean difference|-52.4|||<|0.001|TWO_SIDED|95.0|-58.1|-46.7|||Mixed Models Analysis|||Non-HDL Cholesterol||-46.7|-58.1|<0.001
71739392|NCT04929249|142991634|SUPERIORITY||LS mean difference|-4.6|||<|0.001|TWO_SIDED|95.0|-6.5|-2.8|||Mixed Models Analysis|||VLDL Cholesterol||-2.8|-6.5|<0.001
71739393|NCT04929249|142991634|SUPERIORITY||LS mean difference|-25.3|||<|0.001|TWO_SIDED|95.0|-34.8|-15.8|||Mixed Models Analysis|||Triglycerides||-15.8|-34.8|<0.001
71739394|NCT04929249|142991634|SUPERIORITY||LS mean difference|-36.3|||<|0.001|TWO_SIDED|95.0|-39.7|-32.9|||Mixed Models Analysis|||Apolipoprotein B||-32.9|-39.7|<0.001
71739395|NCT04929249|142991634|SUPERIORITY||LS mean difference|-8.7|||<|0.001|TWO_SIDED|95.0|-10.7|-6.8|||Mixed Models Analysis|||Lipoprotein(a)||-6.8|-10.7|<0.001
71739396|NCT04929249|142991635|SUPERIORITY||Odds Ratio (OR)|1.06||||0.899|TWO_SIDED|95.0|0.43|2.61|||proportional odds model|||||2.61|0.43|0.899
71739397|NCT04929249|142991636|SUPERIORITY||LS mean difference|-0.008||||0.727|TWO_SIDED|95.0|-0.055|0.039|||Regression, Linear|||||0.039|-0.055|0.727
71739398|NCT05758402|142991639|OTHER||Rate difference|1.21||||0.544|TWO_SIDED|95.0|-2.71|5.13|||Chi-squared||Rate difference = detection rate of PsA in EARP group - detection rate of PsA in routine practice group|||5.13|-2.71|0.544
71739399|NCT05758402|142991640|OTHER|||||||0.256|||||||Chi-squared|||Sensitivity||||0.256
71739400|NCT05758402|142991640|OTHER||||||<|0.001|||||||Chi-squared|||Specificity||||<0.001
71739401|NCT05758402|142991640|OTHER|||||||0.336|||||||Fisher Exact|||Positive Predictive Value (PPV)||||0.336
71659468|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.15||||0.005|TWO_SIDED|95.0|-17.24|-3.06|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.06|-17.24|0.005
71659469|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.77|||<|0.001|TWO_SIDED|95.0|-35.1|-18.44|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-18.44|-35.10|<0.001
71659470|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-47.74|||<|0.001|TWO_SIDED|95.0|-61.76|-33.72|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-33.72|-61.76|<0.001
71659471|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-31.69|||<|0.001|TWO_SIDED|95.0|-45.61|-17.76|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.76|-45.61|<0.001
71659472|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.76|||<|0.001|TWO_SIDED|95.0|-26.1|-7.42|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.42|-26.10|<0.001
71659473|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-57.58|||<|0.001|TWO_SIDED|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-44.72|-70.44|<0.001
71659474|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.28||||0.004|TWO_SIDED|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.57|-18.99|0.004
71739402|NCT05758402|142991640|OTHER|||||||0.49|||||||Chi-squared|||Negative Predictive Value (NPV)||||0.490
71739403|NCT05758402|142991641|OTHER|||||||0.101|||||||Wilcoxon (Mann-Whitney)|||Age characteristics||||0.101
71739404|NCT05758402|142991642|OTHER|||||||0.836|||||||Chi-squared|||Gender characteristics||||0.836
71739405|NCT05758402|142991643|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Body Mass Index (BMI) characteristics||||0.520
71739406|NCT05758402|142991644|OTHER|||||||0.216|||||||Chi-squared|||Drinking history characteristics||||0.216
71739407|NCT05758402|142991644|OTHER|||||||0.719|||||||Chi-squared|||Smoking history characteristics||||0.719
71739408|NCT05758402|142991645|OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||Duration of Psoriasis (PsO) characteristics||||0.831
71739409|NCT05758402|142991646|OTHER|||||||0.274|||||||Fisher Exact|||Family history of psoriasis (PsO) characteristics||||0.274
71739410|NCT05758402|142991646|OTHER|||||||0.272|||||||Fisher Exact|||Family history of psoriatic arthritis (PsA) characteristics||||0.272
71739411|NCT05758402|142991647|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||Psoriasis Area and Severity Index (PASI) score characteristics||||0.622
71739412|NCT05758402|142991648|OTHER||||||<|0.001|||||||Chi-squared|||Status of hard-to-treat area involvement characteristics||||<0.001
71739413|NCT05758402|142991648|OTHER||||||<|0.001|||||||Chi-squared|||Status of musculoskeletal symptoms characteristics||||<0.001
71739414|NCT05758402|142991649|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left hand characteristics||||<0.001
71739415|NCT05758402|142991649|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right hand characteristics||||0.010
71739416|NCT05758402|142991649|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of left foot characteristics||||0.001
71739417|NCT05758402|142991649|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||NAPSI score of right foot characteristics||||<0.001
71739418|NCT05758402|142991649|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Total NAPSI score characteristics||||0.001
71739419|NCT05758402|142991650|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66 total joint count characteristics||||<0.001
71739420|NCT05758402|142991650|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||TJC68 total joint count characteristics||||<0.001
71739421|NCT05758402|142991650|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||SJC66/TJC68 total joint count characteristics||||<0.001
71739422|NCT05758402|142991651|OTHER|||||||0.043|||||||Fisher Exact|||Heart diseases||||0.043
71739423|NCT05758402|142991651|OTHER|||||||1|||||||Fisher Exact|||Stroke||||1.000
71739424|NCT05758402|142991651|OTHER|||||||1|||||||Fisher Exact|||Diabetes||||1.000
71739425|NCT05758402|142991651|OTHER|||||||0.019|||||||Chi-squared|||Hyperlipidemia||||0.019
71739426|NCT05758402|142991651|OTHER|||||||0.073|||||||Chi-squared|||Hypertension||||0.073
71739427|NCT05758402|142991651|OTHER|||||||0.377|||||||Fisher Exact|||Fatty liver||||0.377
71739428|NCT00395850|142991661|SUPERIORITY_OR_OTHER||Slope|-1.02|||<|0.05|||||||Repeated Measures Logistic Regression|Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression||Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data||||<0.05
71739429|NCT00395850|142991662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71739430|NCT02211456|142991663|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.05|TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||The data derived from this study was complex multi-level data with errors due to patient-level and intra-patient repeat factors. Accordingly, we used generalized multi-level modelling (GLMM) with random effects.||6.3|1|<0.05
71831769|NCT03752151|143168035|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.002|TWO_SIDED|95.0|0.7|2.7|||t-test, 2 sided|Paired t-test since each participant had LVOT VTI measurements in MARVEL 2 Adaptive and Monitor modes||The null hypothesis is that the mean LVOT VTI during MARVEL 2 Adaptive mode equals the mean LVOT VTI during MARVEL 2 Monitor mode. A sample size of 35 participants with paired LVOT VTI measurements provides 89% power at a type I error rate of 5% to reject the null hypothesis assuming the true difference in LVOT VTI is 2.1 cm with a standard deviation of 3.8 cm.||2.7|0.7|0.002
71831770|NCT01546753|143168077|SUPERIORITY|The change from baseline OFC to week 38 OFC (primary outcome measure) was compared between the two groups using a Mann-Whitney U test.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71659475|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-28.06|||<|0.001|TWO_SIDED|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-19.35|-36.77|<0.001
71659476|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-46.01|||<|0.001|TWO_SIDED|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-32.04|-59.98|<0.001
71659477|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-29.7|||<|0.001|TWO_SIDED|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-15.75|-43.65|<0.001
71659478|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-16.94|||<|0.001|TWO_SIDED|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.29|-26.59|<0.001
71659479|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-52.9|||<|0.001|TWO_SIDED|95.0|-66.06|-39.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-39.75|-66.06|<0.001
71659480|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.93||||0.042|TWO_SIDED|95.0|-17.53|-0.34|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.34|-17.53|0.042
71659481|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.25|||<|0.001|TWO_SIDED|95.0|-36.65|-17.86|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.86|-36.65|<0.001
71659482|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-43.78|||<|0.001|TWO_SIDED|95.0|-57.83|-29.72|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-29.72|-57.83|<0.001
71659483|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-25.75|||<|0.001|TWO_SIDED|95.0|-39.93|-11.57|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-11.57|-39.93|<0.001
71659484|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.49|||<|0.001|TWO_SIDED|95.0|-28.39|-8.59|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-8.59|-28.39|<0.001
71659485|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-45.27|||<|0.001|TWO_SIDED|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-31.58|-58.96|<0.001
71659486|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.88||||0.064|TWO_SIDED|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.50|-18.27|0.064
71659487|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-26.98|||<|0.001|TWO_SIDED|95.0|-36.91|-17.05|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-17.05|-36.91|<0.001
71659488|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-36.26|||<|0.001|TWO_SIDED|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-22.07|-50.45|<0.001
71659489|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.58||||0.01|TWO_SIDED|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-4.52|-32.64|0.010
71659490|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-18.17|||<|0.001|TWO_SIDED|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-7.90|-28.44|<0.001
71733124|NCT02963701|142981364|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|96.12|STANDARD_DEVIATION|14.06|||TWO_SIDED|90.0|91.92|100.51|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||100.51|91.92|
71659491|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-34.21|||<|0.001|TWO_SIDED|95.0|-48.21|-20.21|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-20.21|-48.21|<0.001
71733125|NCT02963701|142981365|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|90.83|STANDARD_DEVIATION|21.49|||TWO_SIDED|90.0|84.87|97.21|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||97.21|84.87|
71733126|NCT02963701|142981366|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.86|STANDARD_DEVIATION|7.89|||TWO_SIDED|90.0|99.33|104.46|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||104.46|99.33|
71733127|NCT02963701|142981367|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.65|STANDARD_DEVIATION|7.01|||TWO_SIDED|90.0|99.4|103.95|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||103.95|99.40|
71733128|NCT02963701|142981368|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|86.53|STANDARD_DEVIATION|16.85|||TWO_SIDED|90.0|82.03|91.28|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||91.28|82.03|
71739431|NCT02910102|142991681|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.3565|TWO_SIDED|95.0|-6.04|2.23||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||2.23|-6.04|0.3565
71739432|NCT02910102|142991682|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.922|TWO_SIDED|95.0|-3.73|3.38||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.||||3.38|-3.73|0.9220
71739433|NCT00095173|142991683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0002|TWO_SIDED|95.0|0.16|0.59|||Log Rank||Abatacept over placebo|||0.59|0.16|0.0002
71739434|NCT00095173|142991684|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71739435|NCT00241904|142991700|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||Intention to treat analysis was used||||<0.001
71739436|NCT00241904|142991701|SUPERIORITY|||||||0.003|||||||General Linear Mixed Model|||||||0.003
71739437|NCT00241904|142991702|SUPERIORITY|||||||0.034|||||||General Linear Mixed Model|||||||0.034
71739438|NCT00241904|142991703|SUPERIORITY||||||<|0.001|||||||General Linear Mixed Model|||||||<0.001
71739439|NCT02038075|142991721|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.38||||0.02|TWO_SIDED|95.0|0.16|0.87|||Regression, Cox|||To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.||.87|.16|.02
71739440|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within \[0.5;2\] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.04|||||TWO_SIDED|95.0|0.81|1.34|||ANOVA|The ANOVA model on the logarithm (log)10 transformation of the concentrations. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.34|0.81|
71659492|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.97||||0.179|TWO_SIDED|95.0|-17.12|3.19|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.19|-17.12|0.179
71889185|NCT01265524|143299553|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.014|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.014
71659493|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.7|||<|0.001|TWO_SIDED|95.0|-31.04|-10.35|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-10.35|-31.04|<0.001
71831771|NCT01546753|143168078|SUPERIORITY|Differences in dichotomous outcomes for the percentage of participants who reach the 5000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test||||||0.01|||||||Fisher Exact|||||||0.01
71831772|NCT01546753|143168079|SUPERIORITY|Differences in dichotomous outcomes including the percentage of subjects who reach the 2000 mg cumulative dose to the walnut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
71659494|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-27.2|||<|0.001|TWO_SIDED|95.0|-41.44|-12.96|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-12.96|-41.44|<0.001
71733129|NCT02963701|142981369|EQUIVALENCE|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|Ratio (%)|106.17|STANDARD_DEVIATION|14.77|||TWO_SIDED|90.0|101.3|111.26|||ANOVA|Results are based on ANOVA model on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment.|The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).|||111.26|101.30|
71733130|NCT02227394|142981456|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.187||||0.727|TWO_SIDED|90.0|-1.098|0.724|||t-test, 2 sided|||||0.724|-1.098|0.727
71733131|NCT02227394|142981457|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.003||||0.366|TWO_SIDED|90.0|-0.002|0.007|||t-test, 2 sided|||||0.007|-0.002|0.366
71733132|NCT02227394|142981459|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.025||||0.486|TWO_SIDED|90.0|-0.035|0.084|||t-test, 2 sided|||||0.084|-0.035|0.486
71733133|NCT02227394|142981460|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.049||||0.413|TWO_SIDED|90.0|-0.052|0.15|||t-test, 2 sided|||||0.150|-0.052|0.413
71733134|NCT02227394|142981461|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.1||||0.375|TWO_SIDED|90.0|-0.289|0.09|||t-test, 2 sided|||||0.090|-0.289|0.375
71831773|NCT01546753|143168080|SUPERIORITY|Differences in dichotomous outcomes such as the percentage of subjects who reach the 2000 mg cumulative dose to the tree nut at the week 38 desensitization OFC was analyzed using Fisher's exact test|||||<|0.01|||||||Fisher Exact|||||||<0.01
71831774|NCT01546753|143168082|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71831775|NCT04247074|143168092|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71831776|NCT04247074|143168093|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71831777|NCT04247074|143168094|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71831778|NCT04247074|143168095|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71831779|NCT00716859|143168096|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.|Mean Difference (Net)|1.46|||||TWO_SIDED|95.0|-0.81|3.74||||||Null hypothesis: latanoprost inferior to timolol (0.5 percent \[%\] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.||3.74|-0.81|
71831780|NCT00716859|143168097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|-1.66|3.02||||||||3.02|-1.66|
71659495|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.9||||0.051|TWO_SIDED|95.0|-27.84|0.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.04|-27.84|0.051
71733135|NCT02227394|142981462|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.009||||0.879|TWO_SIDED|90.0|-0.092|0.11|||t-test, 2 sided|||||0.110|-0.092|0.879
71733136|NCT02227394|142981463|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.023||||0.819|TWO_SIDED|90.0|-0.149|0.195|||t-test, 2 sided|||||0.195|-0.149|0.819
71733137|NCT02227394|142981464|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.4||||0.643|TWO_SIDED|90.0|-1.87|1.07|||t-test, 2 sided|||||1.070|-1.870|0.643
71733138|NCT02227394|142981465|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.011||||0.866|TWO_SIDED|90.0|-0.1|0.122|||t-test, 2 sided|||||0.122|-0.100|0.866
71733139|NCT02227394|142981466|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.054||||0.346|TWO_SIDED|90.0|-0.043|0.152|||t-test, 2 sided|||||0.152|-0.043|0.346
71733140|NCT02227394|142981467|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.029||||0.093|TWO_SIDED|90.0|0.001|0.058|||t-test, 2 sided|||||0.058|0.001|0.093
71733141|NCT02227394|142981468|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.074||||0.686|TWO_SIDED|90.0|-0.386|0.238|||t-test, 2 sided|||||0.238|-0.386|0.686
71733142|NCT02227394|142981470|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-10.368||||0.312|TWO_SIDED|90.0|-27.659|6.922|||t-test, 2 sided|||||6.922|-27.659|0.312
71733143|NCT02227394|142981471|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|-0.02||||0.92|TWO_SIDED|90.0|-0.361|0.321|||t-test, 2 sided|||||0.321|-0.361|0.920
71772595|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.4501|TWO_SIDED|95.0|-1.16|0.52||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.52|-1.16|0.4501
71733144|NCT02227394|142981472|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|0.08||||0.818|TWO_SIDED|90.0|-0.513|0.673|||t-test, 2 sided|||||0.673|-0.513|0.818
71733145|NCT02227394|142981473|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|11.4||||0.034|TWO_SIDED|90.0|2.789|20.011|||t-test, 2 sided|||||20.011|2.789|0.034
71733146|NCT02227394|142981474|OTHER|The difference between the predose and postdose values of test product and the reference product was compared after applying Benjamini-Hochberg correction (BH) to control the false discovery rate and after Holm-Bonferroni correction (Holm) to control the family-wise error rate.|Mean Difference (Net)|5.6||||0.427|TWO_SIDED|90.0|-6.323|17.523|||t-test, 2 sided|||||17.523|-6.323|0.427
71733147|NCT04051827|142981475|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.739|1.42|||||The geometric mean ratio (GMR) of midazolam Cmax on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90 percent (%) confidence intervals (CIs) were calculated on the basis of the within-patient variance using a mixed-effects analysis of variance (ANOVA) model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.42|0.739|
71733148|NCT04051827|142981476|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.676|||||TWO_SIDED|90.0|0.532|0.859|||||The GMR of midazolam AUC∞ on Day 24 (with mobocertinib) versus on Day 1 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||0.859|0.532|
71733149|NCT04051827|142981477|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|1.3|||||TWO_SIDED|90.0|0.886|1.92|||||The GMR of midazolam Cmax on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam Cmax (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.92|0.886|
71772596|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.9227|TWO_SIDED|95.0|-0.68|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.75|-0.68|0.9227
71831781|NCT00716859|143168098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|-1.0|4.25||||||||4.25|-1.00|
71659496|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.76||||0.01|TWO_SIDED|95.0|-24.21|-3.31|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-3.31|-24.21|0.010
71659497|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-23.25||||0.001|TWO_SIDED|95.0|-37.31|-9.2|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-9.20|-37.31|0.001
71659498|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-2.22||||0.676|TWO_SIDED|95.0|-12.63|8.19|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.19|-12.63|0.676
71659499|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-13.15||||0.013|TWO_SIDED|95.0|-23.57|-2.74|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-2.74|-23.57|0.013
71659500|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-20.94||||0.004|TWO_SIDED|95.0|-35.18|-6.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-6.69|-35.18|0.004
71659501|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.39||||0.14|TWO_SIDED|95.0|-24.19|3.4|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.40|-24.19|0.140
71659502|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.06||||0.038|TWO_SIDED|95.0|-21.51|-0.61|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.61|-21.51|0.038
71659503|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-17.9||||0.013||95.0|-32.13|-3.79|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-3.79|-32.13|0.013
71659504|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.85||||0.467||95.0|-14.23|6.53|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||6.53|-14.23|0.467
71659505|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-10.38||||0.049||95.0|-20.73|-0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.02|-20.73|0.049
71659506|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-14.1||||0.05||95.0|-28.22|0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.02|-28.22|0.050
71659507|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.99||||0.255||95.0|-21.73|5.76|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||5.76|-21.73|0.255
71659508|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-6.57||||0.212||95.0|-16.89|3.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.75|-16.89|0.212
71659509|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-15.68||||0.027||95.0|-29.59|-1.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||-1.77|-29.59|0.027
71659510|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-4.39||||0.399|TWO_SIDED|95.0|-14.59|5.82|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||5.82|-14.59|0.399
71661204|NCT00123474|142836041|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-11.2|14.1||||||24 Month Analysis||14.1|-11.2|
71831782|NCT00716859|143168099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.4085|||||TWO_SIDED|95.0|-1.1|2.67||||||||2.67|-1.10|
71831783|NCT00716859|143168104|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3315|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).||||||0.3315
71772597|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.345|TWO_SIDED|95.0|-0.51|1.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.45|-0.51|0.3450
71831784|NCT02918071|143168125|OTHER||percentage|97.4|||||TWO_SIDED|95.0|92.63|99.46|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients successfully administered benralizumab with an AI at home (Week 12)|||99.46|92.63|
71659511|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-7.5||||0.152||95.0|-17.76|2.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.77|-17.76|0.152
71659512|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-11.32||||0.106|TWO_SIDED|95.0|-25.05|2.4|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.40|-25.05|0.106
71659513|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.59||||0.21||95.0|-22.0|4.83|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.83|-22.00|0.210
71659514|NCT02912650|142833433|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-3.13||||0.545||95.0|-13.26|7.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||7.00|-13.26|0.545
71659515|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|20.74|||<|0.001|TWO_SIDED|95.0|10.54|30.94|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||30.94|10.54|<0.001
71659516|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.52||||0.342|TWO_SIDED|95.0|-4.81|13.86|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.86|-4.81|0.342
71659517|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|3.62||||0.459|TWO_SIDED|95.0|-5.98|13.22|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.22|-5.98|0.459
71659518|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|16.2||||0.001|TWO_SIDED|95.0|6.24|26.17|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||26.17|6.24|0.001
71659519|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|17.37|||<|0.001|TWO_SIDED|95.0|7.42|27.31|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.31|7.42|<0.001
71659520|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.91||||0.849|TWO_SIDED|95.0|-10.2|8.42|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.42|-10.2|0.849
71659521|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.08|||<|0.001|TWO_SIDED|95.0|39.53|62.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||62.62|39.53|<0.001
71659522|NCT02912650|142833434|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|5.16||||0.318|TWO_SIDED|95.0|-4.97|15.3|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.30|-4.97|0.318
71659523|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.062|TWO_SIDED|95.0|-0.49|20.21|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.21|-0.49|0.062
71659524|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.6|||<|0.001|TWO_SIDED|95.0|33.45|57.76|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.76|33.45|<0.001
71659525|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|41.07|||<|0.001|TWO_SIDED|95.0|28.76|53.38|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||53.38|28.76|<0.001
71661205|NCT01059344|142836051|SUPERIORITY_OR_OTHER|||||||0.069|||||||Chi-squared|||||||0.069
71661206|NCT01059344|142836052|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71661207|NCT01059344|142836053|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71831785|NCT02918071|143168125|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.41|99.05|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)|||99.05|91.41|
71733150|NCT04051827|142981478|OTHER|Geometric Mean Ratio|Geometric Mean Ratio (GMR)|0.837|||||TWO_SIDED|90.0|0.673|1.04|||||The GMR of midazolam AUC∞ on Day 25 (with mobocertinib) versus on Day 2 (without mobocertinib) were calculated.|The ratios of geometric mean midazolam AUC∞ (in the presence vs absence of mobocertinib) and the associated 2-sided 90% CIs were calculated on the basis of the within-patient variance using a mixed-effects ANOVA model fitting terms for treatment (midazolam in the absence and presence of mobocertinib).||1.04|0.673|
71733151|NCT03344172|142981487|SUPERIORITY||Odds Ratio (OR)|0.52||||0.63|TWO_SIDED|95.0|0.3|6.71|||Fisher Exact|||||6.71|0.30|0.63
71772598|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.274|TWO_SIDED|95.0|-1.58|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.45|-1.58|0.2740
71733152|NCT03344172|142981488|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.52||0.13|TWO_SIDED|95.0|-1.0|-0.25|||t-test, 2 sided|||||-0.25|-1.00|0.13
71733153|NCT01177969|142981503|SUPERIORITY_OR_OTHER|||||||0.04||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.04
71733154|NCT01177969|142981504|SUPERIORITY_OR_OTHER|||||||0.25||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA|||||||.25
71772599|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.914|TWO_SIDED|95.0|-0.92|0.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.82|-0.92|0.9140
71772600|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.0923|TWO_SIDED|95.0|-0.18|2.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.24|-0.18|0.0923
71889186|NCT01265524|143299557|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.0002|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.0002
71831786|NCT02918071|143168125|OTHER||Percentage|93.1|||||TWO_SIDED|95.0|86.86|96.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)|||96.98|86.86|
71831787|NCT02918071|143168126|OTHER||Percentage|97.4|||||TWO_SIDED|95.0|92.69|99.47|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional AI administered at home (Week 12)|||99.47|92.69|
71733155|NCT00869401|142981583|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.222|TWO_SIDED|95.0|0.54|1.16||Using Logrank Test|Log Rank|||||1.16|0.54|.222
71733156|NCT00869401|142981585|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.806||||0.183|TWO_SIDED|95.0|0.59|1.11|||Log Rank|||||1.11|0.59|0.183
71733157|NCT04405245|142981614|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.366||0.807|TWO_SIDED|95.0|-0.63|0.81|||ANCOVA|||||0.81|-0.63|0.8070
71733158|NCT04405245|142981614|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.365||0.013|TWO_SIDED|95.0|-1.64|-0.2|||ANCOVA|||||-0.20|-1.64|0.0130
71733159|NCT02391961|142981623|SUPERIORITY|||||||0.842672|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PSR at baseline and after 3 hours on dalfampridine, and average PSR at baseline and after 3 hours on placebo.||||0.842672
71733160|NCT02391961|142981624|SUPERIORITY|||||||0.972866|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: average PTD at baseline and after 3 hours on dalfampridine, and average PTD at baseline and after 3 hours on placebo.||||0.972866
71733161|NCT02391961|142981625|SUPERIORITY|||||||0.95|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: RA at baseline and after 3 hours on dalfampridine, and RA at baseline and after 3 hours on placebo.||||0.95
71733162|NCT02391961|142981626|SUPERIORITY|||||||0.9|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: MRS at baseline and after 3 hours on dalfampridine, and MRS at baseline and after 3 hours on placebo.||||0.9
71733163|NCT02391961|142981627|SUPERIORITY|||||||0.990995|||||||ANOVA|||Statistical Analysis applies to the 4 subgroups: 25 FWT at baseline and after 3 hours on dalfampridine, and 25 FWT at baseline and after 3 hours on placebo.||||0.990995
71733164|NCT02391961|142981628|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean VFQ-25 scores on dalfampridine vs mean VFQ-25 scores on placebo||||0.71
71733165|NCT02391961|142981629|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to the 2 groups, mean 10-item NOS scores on dalfampridine vs mean 10-item NOS scores on placebo||||0.95
71831788|NCT02918071|143168126|OTHER||Percentage|96.6|||||TWO_SIDED|95.0|91.48|99.06|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional AI administered at home (Week 16)|||99.06|91.48|
71831789|NCT02918071|143168127|OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.0|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)|||3.00|0.00|
71659526|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.74||||0.374|TWO_SIDED|95.0|-5.7|15.17|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.17|-5.70|0.374
71659527|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.09|||<|0.001|TWO_SIDED|95.0|47.93|72.26|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.26|47.93|<0.001
71659528|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|4.3||||0.323|TWO_SIDED|95.0|-4.22|12.81|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.81|-4.22|0.323
71659529|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.86||||0.032|TWO_SIDED|95.0|0.86|18.86|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.86|0.86|0.032
71659530|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.66|||<|0.001|TWO_SIDED|95.0|43.11|68.2|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||68.20|43.11|<0.001
71659531|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.38|||<|0.001|TWO_SIDED|95.0|37.71|63.05|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.05|37.71|<0.001
71772601|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.8482|TWO_SIDED|95.0|-1.11|1.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.35|-1.11|0.8482
71659532|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.61||||0.232|TWO_SIDED|95.0|-3.58|14.8|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.80|-3.58|0.232
71659533|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.92|||<|0.001|TWO_SIDED|95.0|47.39|72.46|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.46|47.39|<0.001
71772602|NCT01227564|143045005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.49|1.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.64|-0.49|0.2840
71659534|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|5.51||||0.179|TWO_SIDED|95.0|-2.52|13.53|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||13.53|-2.52|0.179
71659535|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.37||||0.003|TWO_SIDED|95.0|4.65|22.1|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.10|4.65|0.003
71659536|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
71659537|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
71659538|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659539|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.51|||<|0.001|TWO_SIDED|95.0|47.99|73.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||73.03|47.99|<0.001
71659540|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.08||||0.135|TWO_SIDED|95.0|-1.89|14.05|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.89|0.135
71889187|NCT01265524|143299558|NON_INFERIORITY_OR_EQUIVALENCE|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.072|TWO_SIDED|95.0||||Corrections for multiplicity were not performed and P values \< 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.||||||0.072
71733166|NCT02219503|142981640|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|94.0|
71733167|NCT02219503|142981640|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.||100.0|94.0|
71733168|NCT00343382|142981673|SUPERIORITY_OR_OTHER|||||||0.1675|||||||Kruskal-Wallis|||||||0.1675
71733169|NCT00343382|142981673|SUPERIORITY_OR_OTHER|||||||0.5974|||||||Kruskal-Wallis|||||||0.5974
71733170|NCT00343382|142981674|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||Comparison of Rigors among arms.||||0.002
71733171|NCT00343382|142981674|SUPERIORITY_OR_OTHER|||||||0.006|||||||Kruskal-Wallis|||Comparison of Urinary Frequency among arms||||0.006
71733172|NCT00343382|142981674|SUPERIORITY_OR_OTHER|||||||0.03|||||||Kruskal-Wallis|||Comparison of nausea among arms||||0.030
71733173|NCT00343382|142981674|SUPERIORITY_OR_OTHER|||||||0.062|||||||Kruskal-Wallis|||Comparison of sweating among arms||||0.062
71733174|NCT01985360|142981678|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.79|1.29||||||||1.29|0.79|
71733175|NCT02914561|142981703|SUPERIORITY||Stratified Percentage Difference|12.7||||0.0017|TWO_SIDED|95.0|4.7|20.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||20.7|4.7|0.0017
71733176|NCT02914561|142981703|SUPERIORITY||Stratified Percentage Difference|5.2||||0.173|TWO_SIDED|95.0|-2.4|12.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.7|-2.4|0.1730
71733177|NCT02914561|142981703|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0023|TWO_SIDED|95.0|4.1|19.9|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||19.9|4.1|0.0023
71889188|NCT00008385|143299575|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.25||||0.294|TWO_SIDED|95.0|0.64|2.37||This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses|Log Rank||The 95% confidence interval was repeated confidence interval for the risk ratio|||2.37|0.64|0.294
71733178|NCT02914561|142981703|SUPERIORITY||Stratified Percentage Difference|1.8||||0.6038|TWO_SIDED|95.0|-5.2|8.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.7|-5.2|0.6038
71733179|NCT02914561|142981704|SUPERIORITY||Stratified Percentage Difference|5.5||||0.1365|TWO_SIDED|95.0|-2.0|12.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \>=1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.9|-2.0|0.1365
71733180|NCT02914561|142981704|SUPERIORITY||Stratified Percentage Difference|2.4||||0.5103|TWO_SIDED|95.0|-4.8|9.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||9.5|-4.8|0.5103
71733181|NCT02914561|142981704|SUPERIORITY||Stratified Percentage Difference|0.1||||0.9797|TWO_SIDED|95.0|-6.5|6.6|||Cochran-Mantel-Haenszel|CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\<=1, \>1) at Day 1.||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||6.6|-6.5|0.9797
71733182|NCT02914561|142981704|SUPERIORITY||Stratified Percentage Difference|2.4||||0.4264|TWO_SIDED|95.0|-3.9|8.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.8|-3.9|0.4264
71733183|NCT02914561|142981705|SUPERIORITY||Stratified Percentage Difference|13.7||||0.0839|TWO_SIDED|95.0|-1.0|28.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||28.4|-1.0|0.0839
71889189|NCT00008385|143299576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|TWO_SIDED||||||Log Rank|||||||0.069
71889190|NCT00008385|143299577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|TWO_SIDED||||||Log Rank|||||||0.154
71733184|NCT02914561|142981705|SUPERIORITY||Stratified Percentage Difference|1.5||||0.8288|TWO_SIDED|95.0|-12.1|15.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||15.0|-12.1|0.8288
71733185|NCT02914561|142981706|SUPERIORITY||Stratified Percentage Difference|20.6||||0.0038|TWO_SIDED|95.0|8.2|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||33.1|8.2|0.0038
71733186|NCT02914561|142981706|SUPERIORITY||Stratified Percentage Difference|5.8||||0.3466|TWO_SIDED|95.0|-6.6|18.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||18.3|-6.6|0.3466
71733187|NCT02914561|142981707|SUPERIORITY||Stratified Percentage Difference|6.9||||0.0963|TWO_SIDED|95.0|-1.4|15.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||15.2|-1.4|0.0963
71733188|NCT02914561|142981707|SUPERIORITY||Stratified Percentage Difference|4.2||||0.305|TWO_SIDED|95.0|-3.9|12.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \>=1).||12.2|-3.9|0.3050
71733189|NCT02914561|142981707|SUPERIORITY||Stratified Percentage Difference|11.9||||0.0039|TWO_SIDED|95.0|3.7|20.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.2|3.7|0.0039
71733190|NCT02914561|142981707|SUPERIORITY||Stratified Percentage Difference|1.1||||0.7556|TWO_SIDED|95.0|-6.2|8.5|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||8.5|-6.2|0.7556
71733191|NCT02914561|142981708|SUPERIORITY||Stratified Percentage Difference|12.0||||0.0074|TWO_SIDED|95.0|3.2|20.8|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||20.8|3.2|0.0074
71733192|NCT02914561|142981708|SUPERIORITY||Stratified Percentage Difference|5.5||||0.2159|TWO_SIDED|95.0|-3.2|14.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).||14.1|-3.2|0.2159
71733193|NCT02914561|142981708|SUPERIORITY||Stratified Percentage Difference|11.6||||0.011|TWO_SIDED|95.0|2.6|20.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||20.6|2.6|0.0110
71733194|NCT02914561|142981708|SUPERIORITY||Stratified Percentage Difference|8.2||||0.0593|TWO_SIDED|95.0|-0.4|16.7|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\<=1, \>1).||16.7|-0.4|0.0593
71733195|NCT02914561|142981709|SUPERIORITY||Stratified Percentage Difference|16.8||||0.0382|TWO_SIDED|95.0|2.0|31.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||31.6|2.0|0.0382
71733196|NCT02914561|142981709|SUPERIORITY||Stratified Percentage Difference|5.8||||0.4263|TWO_SIDED|95.0|-8.5|20.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||20.0|-8.5|0.4263
71733197|NCT02914561|142981710|SUPERIORITY||Stratified Percentage Difference|10.9||||0.1827|TWO_SIDED|95.0|-4.7|26.4|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||26.4|-4.7|0.1827
71733198|NCT02914561|142981710|SUPERIORITY||Stratified Percentage Difference|4.0||||0.5944|TWO_SIDED|95.0|-11.1|19.2|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||19.2|-11.1|0.5944
71733199|NCT02914561|142981711|SUPERIORITY||Stratified Percentage Difference|15.2||||0.0512|TWO_SIDED|95.0|1.0|29.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||29.3|1.0|0.0512
71733200|NCT02914561|142981711|SUPERIORITY||Stratified Percentage Difference|-0.2||||0.9801|TWO_SIDED|95.0|-13.3|13.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||13.0|-13.3|0.9801
71733201|NCT02914561|142981712|SUPERIORITY||Stratified Percentage Difference|14.0||||0.19|TWO_SIDED|95.0|-5.1|33.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||33.1|-5.1|0.1900
71733202|NCT02914561|142981712|SUPERIORITY||Stratified Percentage Difference|-5.5||||0.4248|TWO_SIDED|95.0|-22.6|11.6|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||11.6|-22.6|0.4248
71733203|NCT02914561|142981713|SUPERIORITY||Stratified Percentage Difference|19.9||||0.0122|TWO_SIDED|95.0|5.7|34.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||34.0|5.7|0.0122
71733204|NCT02914561|142981713|SUPERIORITY||Stratified Percentage Difference|2.0||||0.7708|TWO_SIDED|95.0|-12.0|16.1|||Cochran-Mantel-Haenszel|||CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).||16.1|-12.0|0.7708
71733205|NCT02914561|142981714|SUPERIORITY||Stratified Percentage Difference|12.0||||0.2631|TWO_SIDED|95.0|-8.3|32.3|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||32.3|-8.3|0.2631
71733206|NCT02914561|142981714|SUPERIORITY||Stratified Percentage Difference|-3.4||||0.6444|TWO_SIDED|95.0|-20.9|14.0|||Cochran-Mantel-Haenszel|||CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).||14.0|-20.9|0.6444
71733207|NCT04881747|142981739|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.875|||||TWO_SIDED|90.0|0.834|0.919||||||||0.919|0.834|
71733208|NCT04881747|142981739|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.889|||||TWO_SIDED|90.0|0.846|0.934||||||||0.934|0.846|
71733209|NCT04881747|142981740|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.914|0.976||||||||0.976|0.914|
71733210|NCT04881747|142981740|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.946|||||TWO_SIDED|90.0|0.914|0.978||||||||0.978|0.914|
71733211|NCT04881747|142981741|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.941|||||TWO_SIDED|90.0|0.91|0.972||||||||0.972|0.910|
71733212|NCT04881747|142981741|EQUIVALENCE|Model: Log(PK) = Treatment + Sequence + Period + Participant(Sequence) + Random Error, where participant within sequence is fitted as a random effect.|Ratio of Geometric least squares mean|0.944|||||TWO_SIDED|90.0|0.913|0.977||||||||0.977|0.913|
71733213|NCT04598269|142981742|SUPERIORITY||Least Square Means (LSM) % Differences|-33.01|STANDARD_ERROR_OF_MEAN|8.971|<|0.001|TWO_SIDED|90.0|-47.95|-18.08||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Model Repeated Measures (MMRM)||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Week 4: Least Square Means (LSM) % differences ATI-1777 arm minus vehicle arm"|||-18.08|-47.95|<0.001
71733214|NCT04598269|142981743|SUPERIORITY||LSM % Differences|-23.53|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.47|-8.59||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|MMRM||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 8: LSM % differences ATI-1777 arm minus vehicle arm"|Day 8 statistical analysis||-8.59|-38.47|0.005
71733215|NCT04598269|142981743|SUPERIORITY||LSM % Differences|-23.44|STANDARD_ERROR_OF_MEAN|8.971||0.005|TWO_SIDED|90.0|-38.38|-8.5||P-value is based on a 1-sided hypothesis test of the superiority of ATI-1777 relative to the vehicle. Significance level at α = 0.05.|Mixed Models Analysis||"Fixed factors for treatment, visit, visit\*treatment, baseline measurement. A compound symmetry covariance matrix was used to account for within-subject variability.~Day 15: LSM % differences ATI-1777 arm minus vehicle arm"|Day 15 statistical analysis||-8.50|-38.38|0.005
71733216|NCT04598269|142981744|SUPERIORITY||Odds Ratio, log|15.7|||<|0.001|TWO_SIDED|90.0|3.9|63.2||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|Regression, Logistic||Active/Vehicle|||63.2|3.9|<0.001
71733217|NCT04598269|142981745|SUPERIORITY||Odds Ratio, log|5.9||||0.003|TWO_SIDED|90.0|2.1|17.0||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Linear||Active/Vehicle|||17.0|2.1|0.003
71733218|NCT04598269|142981746|SUPERIORITY||Odds Ratio, log|1.7||||0.203|TWO_SIDED|90.0|0.6|5.3||1-sided p-value of responders in the treatment groups at 0.05 level of significance|Regression, Logistic||Active/Vehicle|||5.3|0.6|0.203
71733219|NCT04598269|142981747|SUPERIORITY|||||||0.148||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.148
71733220|NCT04598269|142981747|SUPERIORITY|||||||0.017||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.017
71772603|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.1767|TWO_SIDED|95.0|-4.9|0.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.92|-4.90|0.1767
71772604|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.0057|TWO_SIDED|95.0|-7.23|-1.29||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-1.29|-7.23|0.0057
71831790|NCT02918071|143168127|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)|||4.52|0.02|
71831791|NCT02918071|143168127|OTHER||Percentage|0.8|||||TWO_SIDED|95.0|0.02|4.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)|||4.59|0.02|
71733221|NCT04598269|142981747|SUPERIORITY|||||||0.002||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.002
71733222|NCT04598269|142981748|SUPERIORITY|||||||0.088||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.088
71733223|NCT04598269|142981748|SUPERIORITY|||||||0.022||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.022
71733224|NCT04598269|142981748|SUPERIORITY||||||<|0.001||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance.|MMRM|||Week 4 statistical analysis||||<0.001
71733225|NCT04598269|142981749|SUPERIORITY|||||||0.014||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 8 statistical analysis||||0.014
71733226|NCT04598269|142981749|SUPERIORITY|||||||0.069||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Day 15 statistical analysis||||0.069
71733227|NCT04598269|142981749|SUPERIORITY|||||||0.06||||||1-sided p-value of responders in the treatment groups at 0.05 level of significance|MMRM|||Week 4 statistical analysis||||0.060
71733228|NCT03869333|142981755|OTHER|||||||0.504|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.504
71733229|NCT03869333|142981755|OTHER|||||||0.01|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.010
71733230|NCT03869333|142981755|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.038
71733231|NCT03869333|142981755|OTHER|||||||0.016|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.016
71733232|NCT03869333|142981755|OTHER|||||||0.058|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.058
71733233|NCT03869333|142981755|OTHER|||||||0.038|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.038
71733234|NCT03869333|142981756|OTHER|||||||0.129|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.129
71733235|NCT03869333|142981756|OTHER|||||||0.017|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 22||||0.017
71772605|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.13||||0.0176|TWO_SIDED|95.0|-5.69|-0.57||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||-0.57|-5.69|0.0176
71772606|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.679|TWO_SIDED|95.0|-3.98|2.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.61|-3.98|0.6790
71772607|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.9028|TWO_SIDED|95.0|-3.62|3.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||3.20|-3.62|0.9028
71733236|NCT03869333|142981756|OTHER|||||||0.008|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43||||0.008
71733237|NCT03869333|142981756|OTHER|||||||0.011|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.011
71733238|NCT03869333|142981756|OTHER|||||||0.029|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57||||0.029
71733239|NCT03869333|142981756|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71||||0.042
71733240|NCT03869333|142981757|OTHER|||||||0.226|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.226
71733241|NCT03869333|142981757|OTHER|||||||0.601|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.601
71733242|NCT03869333|142981757|OTHER|||||||0.628|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.628
71733243|NCT03869333|142981757|OTHER|||||||0.878|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.878
71733244|NCT03869333|142981758|OTHER|||||||0.762|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Baseline||||0.762
71733245|NCT03869333|142981758|OTHER|||||||0.335|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 8||||0.335
71733246|NCT03869333|142981758|OTHER|||||||0.229|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29||||0.229
71733247|NCT03869333|142981758|OTHER|||||||0.102|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50||||0.102
71733248|NCT03869333|142981759|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.828
71733249|NCT03869333|142981759|OTHER|||||||0.629|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.629
71733250|NCT03869333|142981759|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||>0.999
71733251|NCT03869333|142981759|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
71733252|NCT03869333|142981759|OTHER|||||||0.825|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||0.825
71733253|NCT03869333|142981760|OTHER|||||||0.005|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 22.||||0.005
71733254|NCT03869333|142981760|OTHER|||||||0.082|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 43||||0.082
71733255|NCT03869333|142981760|OTHER|||||||0.293|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.293
71733256|NCT03869333|142981760|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 57||||>0.999
71733257|NCT03869333|142981760|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail test of the difference between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 71||||>0.999
71733258|NCT03869333|142981761|OTHER|||||||0.828|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||0.828
71733259|NCT03869333|142981761|OTHER|||||||0.913|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.913
71733260|NCT03869333|142981761|OTHER|||||||0.924|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.924
71733261|NCT03869333|142981762|OTHER||||||>|0.999|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 8||||>0.999
71733262|NCT03869333|142981762|OTHER|||||||0.412|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 29||||0.412
71733263|NCT03869333|142981762|OTHER|||||||0.847|||||||Fisher Exact|||Fisher's exact 2-tail tests of differences between the 3 Invaplex\[AR-Detox\] dose groups in seroconversion rates at Day 50||||0.847
71733264|NCT03869333|142981763|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.009
71733265|NCT03869333|142981763|OTHER|||||||0.037|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.037
71733266|NCT03869333|142981763|OTHER|||||||0.009|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.009
71733267|NCT03869333|142981763|OTHER|||||||0.036|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.036
71831792|NCT02918071|143168127|OTHER||Percentage|2.6|||||TWO_SIDED|95.0|0.53|7.31|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)|||7.31|0.53|
71733268|NCT03869333|142981763|OTHER|||||||0.042|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.042
71733269|NCT03869333|142981764|OTHER|||||||0.028|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 22||||0.028
71733270|NCT03869333|142981764|OTHER|||||||0.088|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 43||||0.088
71733271|NCT03869333|142981764|OTHER|||||||0.146|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.146
71733272|NCT03869333|142981764|OTHER|||||||0.126|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57||||0.126
71733273|NCT03869333|142981764|OTHER|||||||0.273|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71||||0.273
71733274|NCT03869333|142981766|OTHER|||||||0.348|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 8||||0.348
71733275|NCT03869333|142981766|OTHER|||||||0.179|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 29||||0.179
71733276|NCT03869333|142981766|OTHER|||||||0.089|||||||Kruskal-Wallis|||Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50||||0.089
71733277|NCT03002454|142981773|EQUIVALENCE|"Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment~Anticipated sample size of 50 participants with sample size parameters of:~Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%~Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted."|||||||||||||||||No statistical analysis - insufficient study population|||
71733278|NCT00552409|142981782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-56.0|251.0|||Regression, Linear||Mean urine ACR on treatment was 17% lower among participants assigned to cholecalciferol, compared to participants assigned to placebo, adjusted for baseline values.|||251|-56|
71733279|NCT00849108|142981807|SUPERIORITY_OR_OTHER||sensitivity|0.769||||0.02|TWO_SIDED|95.0|0.655|0.884||P-Value for sensitivity comparison of PET MPI for the same reader|McNemar|two-sided McNemar test with 1 degree of freedom.|No standard deviation can be calculated for PET sensitivity|||0.884|0.655|0.02
71733280|NCT00849108|142981807|SUPERIORITY_OR_OTHER||Sensitivity|0.596||||0.02|TWO_SIDED|95.0|0.463|0.73||p-value for sensitivity comparison for SPECT MPI for the same reader|McNemar||No standard deviation can be calculated for SPECT sensitivity|||0.730|0.463|0.02
71733281|NCT00849108|142981809|SUPERIORITY_OR_OTHER||PET specificity|0.877||||0.317|TWO_SIDED|95.0|0.801|0.952||p-value for comparison of PET specificity for same reader|McNemar||no standard deviation for PET specficity|||0.952|0.801|0.317
71733282|NCT00849108|142981809|SUPERIORITY_OR_OTHER||SPECT specificity|0.836||||0.317|TWO_SIDED|95.0|0.751|0.921||p-value for comparison of SPECT specificity for same reader|McNemar||no standard deviation for SPECT specificity|||0.921|0.751|0.317
71733283|NCT03480009|142981810|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
71733284|NCT03480009|142981810|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||.20
71733285|NCT03480009|142981811|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.81
71733286|NCT03480009|142981811|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||acetaminophen||||.24
71733287|NCT03480009|142981811|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||oxycodone||||.54
71733288|NCT03480009|142981811|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Ibuprofen||||.61
71733289|NCT03480009|142981811|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Acetaminophen||||.24
71733290|NCT03480009|142981812|OTHER|||||||0.99|||||||Wald Chi Square|Wald Chi Square from mixed effects linear regression||||||.99
71659541|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.97||||0.002|TWO_SIDED|95.0|5.3|22.64|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.64|5.30|0.002
71659542|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|54.32|||<|0.001|TWO_SIDED|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||67.29|41.36|<0.001
71831793|NCT02918071|143168127|OTHER||Percentage|3.4|||||TWO_SIDED|95.0|0.94|8.52|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)|||8.52|0.94|
71831794|NCT02918071|143168127|OTHER||Percentage|0.6|||||TWO_SIDED|95.0|0.07|1.99|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)|||1.99|0.07|
71831795|NCT02918071|143168127|OTHER||Percentage|3.0|||||TWO_SIDED|95.0|1.21|6.07|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)|||6.07|1.21|
71831796|NCT02918071|143168127|OTHER||Percentage|1.5|||||TWO_SIDED|95.0|0.69|2.85|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)|||2.85|0.69|
71831797|NCT03149991|143168148|SUPERIORITY|The unstructured covariance matrix structure was used to model nesting of observations within persons. Non-significant site interaction effects were removed one at a time. Least squares means estimates of the linear fixed effects model on SDQ change scores, adjusting for baseline covariates was used to test the primary hypothesis via contrast statements.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.15||0.46|TWO_SIDED||||||Mixed Models Analysis|Because sample sizes per site varied substantially, we used the Kenward-Roger degrees of freedom method.|degrees of freedom = 44.5; t=-0.74|SDQ total was primary outcome \& Day 14 primary endpoint. Change from baseline was calculated for each person at each follow-up. Change score was the dependent variable in a linear fixed effects model, where a (-)number = less severe depression. For group comparison, treatment was coded as 1 \& placebo as 0, thus a (-)value means treatment doing better. Fixed effects: group(brex v placebo), day(1-28), site(6 sites). All 2-\& 3-way interactions were included, as well as a priori defined covariates.||||0.46
71831798|NCT03149991|143168148|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11||0.04|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom = 41.3; t=2.07.|Secondary Aim: To evaluate the short-term effect of brexpiprazole, as measured by the Symptoms of Depression Questionnaire (SDQ), on Day 2. We used the same model as in Aim 1 to test this hypothesis.||||0.04
71831799|NCT03149991|143168148|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.92|TWO_SIDED||||||Mixed Models Analysis||Degrees of freedom=38.2; t=0.10.|To evaluate the long-term effect of brexpiprazole as measured by the Symptoms of Depression Questionnaire (SDQ) on Day 28. The same model as was used in Aim 1 was used to test this hypothesis.||||0.92
71831800|NCT03149991|143168149|SUPERIORITY||Chi-squared test|0.51||||0.47|TWO_SIDED|||||This p-value was not adjusted, however there were adjustments when using a logistic regression in Statistical Analysis #2.|Chi-squared|||We used a Chi-squared test to assess differences between treatment and control in terms of percent of participants achieving a long-term sustained response, as measured by achieving a 50% or greater reduction on the MADRS on Day 28.||||0.47
71889191|NCT00066690|143299591|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.66|1.04|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.04|0.66|0.1
71889192|NCT00066690|143299591|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.86|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.86|0.53|
71889193|NCT00066690|143299592|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.09|TWO_SIDED|95.0|0.3|1.03|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.|||1.03|0.3|0.09
71659543|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|46.74|||<|0.001|TWO_SIDED|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.99|33.50|<0.001
71661208|NCT01059344|142836054|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.010
71661209|NCT01059344|142836055|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71661210|NCT01059344|142836056|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71733291|NCT03480009|142981812|OTHER|||||||0.56|||||||Wald Chi Square|P-value from Wald chi-square from mixed effects linear regression||||||.56
71831801|NCT03149991|143168149|SUPERIORITY||Odds Ratio (OR)|1.83||||0.35|TWO_SIDED|95.0|0.52|6.44|||Regression, Logistic|Adjusted for a priori defined covariates also included in Aim 1.||Logistic regression was used to assess a difference in 50% reduction on the MADRS on Day 28 between groups.||6.44|0.52|0.35
71831802|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|1.59||0.04|TWO_SIDED|||||Because tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 41.0, t=2.13.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 2.||||0.04
71889194|NCT00066690|143299592|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.49|0.83|||||Tamoxifen was the reference group in the estimation of the hazard ratio.|||0.83|0.49|
71889195|NCT00066690|143299593|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4|TWO_SIDED|95.0|0.66|1.18|||Log Rank||T was the reference group in the estimation of the hazard ratio.|||1.18|0.66|0.40
71889196|NCT00066690|143299593|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.96|||||T was the reference group in the estimation of hazard ratio.|||0.96|0.52|
71889197|NCT00066690|143299594|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.48|0.92|||Log Rank||T was the reference group in the estimation of the hazard ratio|||0.92|0.48|0.01
71889198|NCT00066690|143299594|SUPERIORITY|\[not specified\]|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.62|1.15|||||T was the reference group in the estimation of hazard ratio|||1.15|0.62|
71733292|NCT03480009|142981813|OTHER|||||||0.07|||||||Fisher Exact|||||||.07
71889199|NCT05256888|143299596|SUPERIORITY||Slope|-1.77|STANDARD_ERROR_OF_MEAN|1.08||0.11|TWO_SIDED||||||Regression, Linear|||"In a linear model to assess group effects on fatigue at 12 weeks, adjusting for baseline levels of fatigue:~Effect of group = -1.77±1.08, p=0.11, favoring the TRE group."||||0.11
71889200|NCT03116113|143299602|SUPERIORITY||||||=|0.3181|||||||Fisher's Exact-Boschloo test|||||||=0.3181
71889201|NCT03116113|143299602|SUPERIORITY||||||=|0.5177|||||||Fisher's Exact-Boschloo test|||||||=0.5177
71889202|NCT05195528|143299659|SUPERIORITY||Difference in least square mean|17.1|||<|0.0001|TWO_SIDED|95.0|11.81|22.45||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.45|11.81|<0.0001
71889203|NCT05195528|143299659|SUPERIORITY||Least square mean difference|16.7|||<|0.0001|TWO_SIDED|95.0|11.36|22.04||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||22.04|11.36|<0.0001
71889204|NCT05195528|143299660|SUPERIORITY||Least square mean difference|15.8|||<|0.0001|TWO_SIDED|95.0|9.93|21.6||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||21.60|9.93|<0.0001
71889205|NCT05195528|143299660|SUPERIORITY||Least square mean difference|13.7|||<|0.0001|TWO_SIDED|95.0|7.84|19.54||P-values were obtained from the general linear model with treatment group as factor and severity and frequency of heartburn at baseline as covariates.|General linear model|||||19.54|7.84|<0.0001
71889206|NCT01552902|143299661|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-3.4|||=|0.0013|TWO_SIDED|95.0|-5.4|-1.3|||Mixed Models Analysis|||The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.||-1.3|-5.4|= 0.0013
71889207|NCT01552902|143299661|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.0|-6.0|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-6|-11|< 0.0001
71889208|NCT01552902|143299661|SUPERIORITY_OR_OTHER_LEGACY||Difference in LSM|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.6|-2.6|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.||-2.6|-7.6|< 0.0001
71889209|NCT06415305|143299675|SUPERIORITY||||||<|0.008|||||||Wilcoxon signed rank tests|||||||<0.008
71889210|NCT06415305|143299676|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
71889211|NCT06415305|143299677|SUPERIORITY|||||||0.008|||||||Wilcoxon signed rank tests|||||||0.008
71889212|NCT06415305|143299678|SUPERIORITY|||||||0.009|||||||Wilcoxon signed rank tests|||||||0.009
71733293|NCT03480009|142981813|OTHER|||||||0.5|||||||Fisher Exact|||||||.50
71889213|NCT02487108|143299685|OTHER||LS Mean Difference|38.9|||<|0.001|TWO_SIDED|95.0|19.931|57.855|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||57.855|19.931|<0.001
71889214|NCT02487108|143299685|OTHER||LS Mean Difference|44.0|||<|0.001|TWO_SIDED|95.0|25.122|62.881|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||62.881|25.122|<0.001
71889215|NCT02487108|143299685|OTHER||LS Mean Difference|53.4|||<|0.001|TWO_SIDED|95.0|34.589|72.282|||ANCOVA|||Analysis was performed using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate.||72.282|34.589|<0.001
71889216|NCT00600171|143299722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.208|TWO_SIDED|95.0|-0.036|0.164|||ANCOVA|||||0.164|-0.036|0.208
71889217|NCT00600171|143299722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069||||0.169|TWO_SIDED|95.0|-0.029|0.168|||ANCOVA|||||0.168|-0.029|0.169
71889218|NCT00600171|143299722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.011|TWO_SIDED|95.0|0.03|0.23|||ANCOVA|||||0.230|0.030|0.011
71661211|NCT01059344|142836057|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
71733294|NCT01563172|142981814|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|6.95||||0.0008|TWO_SIDED|95.0|2.91|10.98||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||10.98|2.91|0.0008
71889219|NCT00600171|143299722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.121||||0.016|TWO_SIDED|95.0|0.023|0.22|||ANCOVA|||||0.220|0.023|0.016
71889220|NCT00600171|143299722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.001|TWO_SIDED|95.0|0.062|0.261|||ANCOVA|||||0.261|0.062|0.001
71889221|NCT01989221|143299774|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|0.12|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean GCSI-DD scores during one week at baseline were compared to mean GCSI-DD scores during the second week of Sancuso treatment.|||||<0.01
71889222|NCT01989221|143299775|OTHER||Mean Difference (Final Values)|1.01|STANDARD_DEVIATION|0.27|<|0.01|TWO_SIDED|95.0||||Threshold for statistical significance was p \< 0.05|t-test, 2 sided||Mean nausea and vomiting symptom scores during one week at baseline were compared to mean symptom scores during the second week of Sancuso treatment.|||||<0.01
71733295|NCT01563172|142981815|SUPERIORITY_OR_OTHER||LS mean difference|5.7||||0.0049|TWO_SIDED|95.0|1.74|9.66||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||9.66|1.74|0.0049
71733296|NCT01563172|142981816|SUPERIORITY_OR_OTHER||LS mean difference|-10.86|||<|0.0001|TWO_SIDED|95.0|-14.77|-6.94||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-6.94|-14.77|<0.0001
71733297|NCT01563172|142981817|SUPERIORITY_OR_OTHER||LS mean difference|-9.61|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.54||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-5.54|-13.68|<0.0001
71733298|NCT01563172|142981818|SUPERIORITY_OR_OTHER||LS mean difference|15.38|||<|0.0001|TWO_SIDED|95.0|11.45|19.31||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||19.31|11.45|<0.0001
71733299|NCT01563172|142981819|SUPERIORITY_OR_OTHER||LS Mean Difference|514.01|||<|0.0001|TWO_SIDED|95.0|283.02|744.99||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||744.99|283.02|<0.0001
71733300|NCT01563172|142981820|SUPERIORITY_OR_OTHER||LS Mean difference|265.92||||0.0218|TWO_SIDED|95.0|39.0|492.83||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||492.83|39.00|0.0218
71733301|NCT01563172|142981821|SUPERIORITY_OR_OTHER||LS mean difference|-822.88|||<|0.0001|TWO_SIDED|95.0|-1047.34|-598.42||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-598.42|-1047.34|<0.0001
71733302|NCT01563172|142981822|SUPERIORITY_OR_OTHER||LS mean difference|-574.79|||<|0.0001|TWO_SIDED|95.0|-808.08|-341.5||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||-341.50|-808.08|<0.0001
71733303|NCT01563172|142981823|SUPERIORITY_OR_OTHER||LS mean difference|1294.34|||<|0.0001|TWO_SIDED|95.0|1069.24|1519.43||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."|||1519.43|1069.24|<0.0001
71733304|NCT02014584|142981846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.27|TWO_SIDED|95.0|-4.7|18.8|||Fisher's Exact Test|||||18.8|-4.7|0.27
71733305|NCT02014584|142981892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.5||||0.62|TWO_SIDED|95.0|-10.4|3.4|||Fisher's Exact Test||DB Week 4|||3.4|-10.4|0.62
71733306|NCT02014584|142981892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.4||||0.34|TWO_SIDED|95.0|-4.7|17.6|||Fisher's Exact Test||DB Week 12|||17.6|-4.7|0.34
71733307|NCT02014584|142981892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.31|TWO_SIDED|95.0|-4.2|16.7|||Fisher's Exact Test||DB Week 24|||16.7|-4.2|0.31
71889223|NCT00849017|143299776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.58|||ANCOVA|||||-0.58|-1.11|<0.0001
71889224|NCT00849017|143299776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.77|||ANCOVA|||||-0.77|-1.31|<0.0001
71661212|NCT01739348|142836058|SUPERIORITY||Difference in Least Squares Mean|0.2||||0.6287|TWO_SIDED|97.51|-0.9|1.3|||Longitudinal ANCOVA|||||1.3|-0.9|0.6287
71733308|NCT02014584|142981894|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.082|TWO_SIDED|95.0|-0.2|3.0|||t-test from general linear model||DB Week 4|||3.0|-0.2|0.082
71733309|NCT02014584|142981894|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.09||0.25|TWO_SIDED|95.0|-3.4|0.9|||t-test from general linear model||DB Week 12|||0.9|-3.4|0.25
71733310|NCT02014584|142981894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.04||0.99|TWO_SIDED|95.0|-2.0|2.1|||t-test from general linear model||DB Week 24|||2.1|-2.0|0.99
71733311|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.46|TWO_SIDED|95.0|-0.4|0.9|||t-test from general linear model||Erectile Function DB Week 4|||0.9|-0.4|0.46
71733312|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.52||0.14|TWO_SIDED|95.0|-1.8|0.3|||t-test from general linear model||Erectile Function DB Week 12|||0.3|-1.8|0.14
71733313|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.27|TWO_SIDED|95.0|-1.9|0.5|||t-test from general linear model||Erectile Function DB Week 24|||0.5|-1.9|0.27
71889225|NCT01111305|143299815|EQUIVALENCE|Equivalence is defined as p≥0.05||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71831803|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|2.94||0.73|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.35|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 14.||||0.73
71889226|NCT00624520|143299838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|891.0||||0.18|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.18
71889227|NCT00624520|143299839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
71733314|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.13|TWO_SIDED|95.0|-0.1|0.8|||t-test from general linear model||Intercourse satisfaction DB Week 4|||0.8|-0.1|0.13
71733315|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.73|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 12|||0.5|-0.8|0.73
71733316|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.64|TWO_SIDED|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 24|||0.5|-0.8|0.64
71733317|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|-0.1|0.5|||t-test from general linear model||Orgasmic function DB Week 4|||0.5|-0.1|0.23
71733318|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|-0.5|0.2|||t-test from general linear model||Orgasmic function DB Week 12|||0.2|-0.5|0.33
71733319|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.23||0.64|TWO_SIDED|95.0|-0.6|0.3|||t-test from general linear model||Orgasmic function DB Week 24|||0.3|-0.6|0.64
71733320|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|95.0|-0.1|0.7|||t-test from general linear model||Sexual desire DB Week 4|||0.7|-0.1|0.19
71733321|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.28|TWO_SIDED|95.0|-0.7|0.2|||t-test from general linear model||Sexual desire DB Week 12|||0.2|-0.7|0.28
71733322|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||1|TWO_SIDED|95.0|-0.5|0.5|||t-test from general linear model||Sexual desire DB Week 24|||0.5|-0.5|1.00
71733323|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.28|TWO_SIDED|95.0|-0.2|0.5|||t-test from general linear model||Overall sexual satisfaction DB Week 4|||0.5|-0.2|0.28
71733324|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.64|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 12|||0.3|-0.5|0.64
71733325|NCT02014584|142981896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.69|TWO_SIDED|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 24|||0.3|-0.5|0.69
71733326|NCT02014584|142981898|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.1|STANDARD_ERROR_OF_MEAN|1.14||0.33|TWO_SIDED|95.0|-1.1|3.4|||t-test from general linear model||DB Week 12|||3.4|-1.1|0.33
71733327|NCT02014584|142981898|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.14||0.004|TWO_SIDED|95.0|1.1|5.6|||t-test from general linear model||DB Week 24|||5.6|1.1|0.004
71733328|NCT02014584|142981900|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.22|TWO_SIDED|95.0|-1.7|0.4|||t-test from general linear model||DB Week 12|||0.4|-1.7|0.22
71733329|NCT02014584|142981900|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.76||0.5|TWO_SIDED|95.0|-2.0|1.0|||t-test from general linear model||DB Week 24|||1.0|-2.0|0.50
71733330|NCT00752726|142981910|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.263|STANDARD_ERROR_OF_MEAN|0.115||0.0244|TWO_SIDED|95.0|0.035|0.491||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.491|0.035|0.0244
71733331|NCT00752726|142981911|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.172|STANDARD_ERROR_OF_MEAN|0.0834||0.0415|TWO_SIDED|95.0|0.007|0.337||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.||0.337|0.007|0.0415
71733332|NCT00752726|142981912|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.99|STANDARD_ERROR_OF_MEAN|0.881||0.026|TWO_SIDED|95.0|0.25|3.74||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.74|0.25|0.026
71733333|NCT00752726|142981913|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.642|STANDARD_ERROR_OF_MEAN|0.7174||0.0242|TWO_SIDED|95.0|0.219|3.065||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.065|0.219|0.0242
71659544|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659545|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659546|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71733334|NCT00752726|142981914|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.704||0.039|TWO_SIDED|95.0|0.07|2.87||P-value was not adjusted for multiple comparisons|ANCOVA|Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2.87|0.07|0.039
71733335|NCT00752726|142981915|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.974||0.085|TWO_SIDED|95.0|-0.24|3.63||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||3.63|-0.24|0.085
71733336|NCT00752726|142981917|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.0232||0.3235|TWO_SIDED|95.0|-0.069|0.023||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||0.023|-0.069|0.3235
71733337|NCT00752726|142981918|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|783.8|STANDARD_ERROR_OF_MEAN|726.54||0.28|TWO_SIDED|95.0|-657.3|2224.9||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.||2224.9|-657.3|0.28
71733338|NCT00752726|142981919|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|1.542||0.2847|TWO_SIDED|95.0|-1.4|4.72||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.|Adjusted mean difference was calculated as placebo minus orlistat.|The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.||4.72|-1.40|0.2847
71733339|NCT04232215|142981928|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.64|TWO_SIDED|95.0|-10.2|6.1|||Regression, Linear|A generalized linear model adjusting by intervention group and the order of randomization was conducted.||Difference in ease of use between our standard fetal Doppler and HeraBEAT™ device, as measured by the System Usability Survey (SUS) will be the primary outcome. We aim to recruit 50 participants (50 per arm, with cross-over) for a 99.7% power to detect a 10-point difference in SUS, as this accounts for a withdraw / post-randomization exclusion as high as 10% (assuming a proportion of expectant mothers to withdraw participation after being enrolled or found to not meet criteria after the fact).||6.1|-10.2|0.64
71733340|NCT04232215|142981929|SUPERIORITY||Risk Ratio (RR)|1.2||||0.63|TWO_SIDED|95.0|0.57|2.53|||Chi-squared|||||2.53|0.57|0.63
71733341|NCT01555125|142981940|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71733342|NCT01555125|142981940|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71889228|NCT00624520|143299840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED||||||ANOVA|||||||0.003
71889229|NCT00624520|143299841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.011|TWO_SIDED||||||ANOVA|||||||0.011
71659547|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659548|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659549|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71661213|NCT01739348|142836058|SUPERIORITY||Difference in Least Squares Mean|0.4||||0.4625|TWO_SIDED|97.51|-0.8|1.5|||Longitudinal ANCOVA|||||1.5|-0.8|0.4625
71733343|NCT01555125|142981941|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71733344|NCT01555125|142981941|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71733345|NCT02651220|142981963|EQUIVALENCE|Bioequivalence was based on 90% confidence interval within 80-125%.|Bioavailability|100.28|||||TWO_SIDED|90.0|96.78|103.91||||||||103.91|96.78|
71733346|NCT02651220|142981964|EQUIVALENCE|Bioequivalence is based on 90% confidence interval within 80-125%.|Bioavailability|99.73|||||TWO_SIDED|90.0|96.04|103.56||||||||103.56|96.04|
71733347|NCT02651220|142981965|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71889230|NCT00624520|143299842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.048|TWO_SIDED||||||ANOVA|||||||0.048
71889231|NCT00624520|143299843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71889232|NCT00624520|143299844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71831804|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-2.86|STANDARD_ERROR_OF_MEAN|3.16||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.8, t=-0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the MADRS change scores, reporting here information for Day 28.||||0.37
71733348|NCT00896441|142981966|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|One sample t-test||||||<0.01
71733349|NCT00896441|142981968|OTHER||||||<|0.006|||||||t-test, 2 sided|Single group t-test||||||<.006
71733350|NCT01078168|142982010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3769||||0.0347|TWO_SIDED|95.0|0.03025|0.7235||threshold: p\<0.05|t-test, 2 sided|||||0.7235|0.03025|0.0347
71733351|NCT01280695|142982036|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.0||||0.4195|TWO_SIDED|95.0|-34.0|14.0|||Wilcoxon (Mann-Whitney)|||||14.0|-34.0|0.4195
71733352|NCT01280695|142982036|SUPERIORITY_OR_OTHER||Median Difference (Net)|-18.0||||0.0811|TWO_SIDED|95.0|-38.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-38.0|0.0811
71733353|NCT01280695|142982036|SUPERIORITY_OR_OTHER||Median Difference (Net)|-20.0||||0.0639|TWO_SIDED|95.0|-38.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-38.0|0.0639
71733354|NCT01280695|142982036|SUPERIORITY_OR_OTHER||Median Difference (Net)|-32.0||||0.0022|TWO_SIDED|95.0|-50.0|-12.0|||Wilcoxon (Mann-Whitney)|||||-12.0|-50.0|0.0022
71733355|NCT02720692|142982044|SUPERIORITY||||||<|0.05||||||P\<0.05 applies to Day 1 (0-24 Hours; p=0.0033), Days 1-2 (0-48 Hours; p=0.0077), and Days 1-3 (0-72 Hours; p=0.0152).|ANCOVA|||||||<0.05
71733356|NCT05011513|142982045|SUPERIORITY|||||||0.6027|||||||Log Rank|||||||0.6027
71733357|NCT05011513|142982047|SUPERIORITY|||||||0.1796||||||P-value reported for COVID-19 hospitalization and death due to any cause.|Normal approximation|||||||0.1796
71733358|NCT05011513|142982049|SUPERIORITY|||||||0.0971|||||||Negative binomial|||||||0.0971
71772608|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45||||0.76|TWO_SIDED|95.0|-3.36|2.47||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||2.47|-3.36|0.7600
71889233|NCT00624520|143299845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71889234|NCT00624520|143299846|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
71889235|NCT00624520|143299847|SUPERIORITY_OR_OTHER||Effect size (Cohen's d)|0.38||||0.025|TWO_SIDED|||||P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.|ANCOVA||Range of Cohen's d for small effect is 0.20 - 0.50|||||0.025
71733359|NCT05011513|142982051|SUPERIORITY||Odds Ratio (OR)|0.819||||0.1622|TWO_SIDED|95.0|0.618|1.084|||Regression, Logistic|||Main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.084|0.618|0.1622
71733360|NCT05011513|142982052|SUPERIORITY|||||||0.4298|||||||Log Rank|||||||0.4298
71733361|NCT05011513|142982055|SUPERIORITY||Odds Ratio (OR)|0.802||||0.1086|TWO_SIDED|95.0|0.613|1.05|||Regression, Logistic|||Main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status (positive/negative), vaccination status (complete/not vaccinated) and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL).||1.050|0.613|0.1086
71733362|NCT05011513|142982056|SUPERIORITY||Odds Ratio (OR)|50.333||||0.3262|TWO_SIDED|95.0|13.163|192.472|||Breslow-Day Test|||||192.472|13.163|0.3262
71733363|NCT05011513|142982056|SUPERIORITY||Odds Ratio (OR)|22.224|||||TWO_SIDED|95.0|8.36|59.08||||||Odds ratio for Day 5 vs Day 1||59.080|8.360|
71733364|NCT03878758|142982060|SUPERIORITY|The average difference in incidence of needle bending with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.39||||0.591|TWO_SIDED|95.0|-1.82|1.04|||Fisher Exact|||||1.04|-1.82|0.591
71733365|NCT03878758|142982060|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.13||||0.931|TWO_SIDED|95.0|-2.8|3.06|||Fisher Exact|||||3.06|-2.8|0.931
71733366|NCT03878758|142982060|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.42||||0.723|TWO_SIDED|95.0|-1.91|2.75|||Fisher Exact|||||2.75|-1.91|0.723
71733367|NCT03878758|142982061|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-5.7|||<|0.001|TWO_SIDED|95.0|-9.0|-3.5|||Fisher Exact|||||-3.5|-9.0|<0.001
71733368|NCT03878758|142982061|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-14.09||||0.026|TWO_SIDED|95.0|-26.49|-1.69||Although a site difference was detected - all sites combined p-value was generated,|Fisher Exact|||||-1.69|-26.49|0.026
71733369|NCT03878758|142982061|SUPERIORITY|The average difference in percentage of occurrence with BD Nano vs.Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.2||||0.644|TWO_SIDED|95.0|-1.9|0.6|||Fisher Exact|||||0.6|-1.9|0.644
71733370|NCT03878758|142982062|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.8|||||TWO_SIDED|95.0|0.62|0.98||||||||0.98|0.62|
71733371|NCT03878758|142982062|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|1.0|||||TWO_SIDED|95.0|0.8|1.16||||||||1.16|0.8|
71733372|NCT03878758|142982062|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.3|||||TWO_SIDED|95.0|0.13|0.49||||||||0.49|0.13|
71733373|NCT03878758|142982063|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.192|||<|0.001|ONE_SIDED|95.0||-0.141|||Mixed Models Analysis|||BD Nano Pro vs Artsana 34G||-0.141||<0.001
71733374|NCT03878758|142982063|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.122||||0.104|ONE_SIDED|95.0||0.016|||Mixed Models Analysis|||BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.||0.016||0.104
71733375|NCT03878758|142982063|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary. The upper bound of the confidence interval was compared to 0.|Mean Difference (Net)|-0.068||||0.003|ONE_SIDED|95.0||-0.017|||Mixed Models Analysis|||BD NANO vs Comfort EZ 33G||-0.017||0.003
71733376|NCT03878758|142982064|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
71733377|NCT03878758|142982064|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
71733378|NCT03878758|142982064|SUPERIORITY|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||||1.2|-0.4|
71733379|NCT02905006|142982088|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71733380|NCT02905006|142982088|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71733381|NCT02905006|142982088|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71772609|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.4089|TWO_SIDED|95.0|-4.51|1.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.86|-4.51|0.4089
71733382|NCT02905006|142982088|SUPERIORITY||||||<|0.0001||||||P-value evaluating dose response excludes the BKZ Dose 3 group; is based on a logistic regression model with fixed effects for region, prior biologic exposure, continuous treatment variable with values of -2, -1, 0, 1, 2 for the remaining groups.|Regression, Logistic|||||||<0.0001
71772610|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17||||0.1964|TWO_SIDED|95.0|-5.49|1.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.15|-5.49|0.1964
71733383|NCT02905006|142982089|SUPERIORITY||Odds Ratio (OR)|21.43|||=|0.0001|TWO_SIDED|95.0|4.51|101.88|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||101.88|4.51|=0.0001
71733384|NCT02905006|142982089|SUPERIORITY||Odds Ratio (OR)|63.21|||<|0.0001|TWO_SIDED|95.0|12.9|309.83|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||309.83|12.90|<0.0001
71733385|NCT02905006|142982089|SUPERIORITY||Odds Ratio (OR)|62.35|||<|0.0001|TWO_SIDED|95.0|12.61|308.29|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||308.29|12.61|<0.0001
71733386|NCT02905006|142982089|SUPERIORITY||Odds Ratio (OR)|130.35|||<|0.0001|TWO_SIDED|95.0|24.5|693.51|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||693.51|24.50|<0.0001
71733387|NCT02905006|142982089|SUPERIORITY||Odds Ratio (OR)|69.4|||<|0.0001|TWO_SIDED|95.0|14.07|342.4|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||342.40|14.07|<0.0001
71733388|NCT02905006|142982090|SUPERIORITY||Odds Ratio (OR)|18.23|||=|0.0003|TWO_SIDED|95.0|3.79|87.76|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||87.76|3.79|=0.0003
71733389|NCT02905006|142982090|SUPERIORITY||Odds Ratio (OR)|39.6|||<|0.0001|TWO_SIDED|95.0|8.19|191.59|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||191.59|8.19|<0.0001
71733390|NCT02905006|142982090|SUPERIORITY||Odds Ratio (OR)|77.27|||<|0.0001|TWO_SIDED|95.0|15.19|392.93|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||392.93|15.19|<0.0001
71733391|NCT02905006|142982090|SUPERIORITY||Odds Ratio (OR)|141.99|||<|0.0001|TWO_SIDED|95.0|26.26|767.72|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||767.72|26.26|<0.0001
71733392|NCT02905006|142982090|SUPERIORITY||Odds Ratio (OR)|58.52|||<|0.0001|TWO_SIDED|95.0|11.89|288.0|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||288.00|11.89|<0.0001
71733393|NCT02905006|142982091|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71733394|NCT02905006|142982091|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71733395|NCT02905006|142982091|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71733396|NCT02905006|142982091|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71733397|NCT02905006|142982091|SUPERIORITY||||||<|0.0001||||||The placebo treatment group contained no PASI90 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.|Fisher Exact|||||||<0.0001
71831805|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|0.85||0.06|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||degrees of freedom = 40.3, t=1.94.|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 2.||||0.06
71889236|NCT00624520|143299848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80.0||||0.81|TWO_SIDED|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."||||0.81
71733398|NCT02905006|142982092|SUPERIORITY||Odds Ratio (OR)|32.65|||<|0.0001|TWO_SIDED|95.0|6.82|156.38|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||156.38|6.82|<0.0001
71733399|NCT02905006|142982092|SUPERIORITY||Odds Ratio (OR)|94.51|||<|0.0001|TWO_SIDED|95.0|18.54|481.86|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||481.86|18.54|<0.0001
71733400|NCT02905006|142982092|SUPERIORITY||Odds Ratio (OR)|117.66|||<|0.0001|TWO_SIDED|95.0|22.08|626.89|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||626.89|22.08|<0.0001
71733401|NCT02905006|142982092|SUPERIORITY||Odds Ratio (OR)|280.76|||<|0.0001|TWO_SIDED|95.0|44.06|1789.24|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||1789.24|44.06|<0.0001
71733402|NCT02905006|142982092|SUPERIORITY||Odds Ratio (OR)|107.83|||<|0.0001|TWO_SIDED|95.0|20.82|558.57|||Regression, Logistic|Confidence intervals, odds ratios, p-values derived from a logistic regression model with fixed effects for treatment, region, prior bio-exposure.||||558.57|20.82|<0.0001
71733403|NCT02905006|142982093|SUPERIORITY||||||=|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0001
71733404|NCT02905006|142982093|SUPERIORITY||||||=|0.0002|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||=0.0002
71733405|NCT02905006|142982093|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
71733406|NCT02905006|142982093|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
71733407|NCT02905006|142982093|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The placebo treatment group contained no PASI100 responders and as such the p-values for the pairwise comparisons are based upon the Fisher's exact test.||||<0.0001
71772611|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.2234|TWO_SIDED|95.0|-4.58|1.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.09|-4.58|0.2234
71772612|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6186|TWO_SIDED|95.0|-3.52|2.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.12|-3.52|0.6186
71772613|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.5853|TWO_SIDED|95.0|-3.6|2.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.06|-3.60|0.5853
71772614|NCT01227564|143045006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.5541|TWO_SIDED|95.0|-3.23|1.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.75|-3.23|0.5541
71772615|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.937|TWO_SIDED|95.0|-2.09|1.93||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.93|-2.09|0.9370
71733408|NCT02429791|142982131|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.3|3.0|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI).|||3.0|-4.3|
71733409|NCT02429791|142982133|OTHER||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-1.9|4.0|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||4.0|-1.9|
71733410|NCT02429791|142982144|OTHER|||||||0.007||||||P-value for interaction between treatment group and baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
71889237|NCT01925209|143299850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.59|STANDARD_ERROR_OF_MEAN|14.331||0.221|TWO_SIDED|99.0|-19.63|54.8|||mixed model repeated measures|||||54.80|-19.63|0.2210
71889238|NCT01925209|143299850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.59|STANDARD_ERROR_OF_MEAN|14.176||0.1909|TWO_SIDED|99.0|-18.21|55.4|||mixed model repeated measure|||||55.40|-18.21|0.1909
71733411|NCT02429791|142982144|SUPERIORITY||Odds Ratio (OR)|0.958||||0.275|TWO_SIDED|95.0|0.888|1.034||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.034|0.888|0.275
71733412|NCT02429791|142982144|SUPERIORITY||Odds Ratio (OR)|0.902||||0.112|TWO_SIDED|95.0|0.793|1.025||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||1.025|0.793|0.112
71733413|NCT02429791|142982144|SUPERIORITY||Odds Ratio (OR)|0.847||||0.002|TWO_SIDED|95.0|0.763|0.942||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.|||0.942|0.763|0.002
71733414|NCT02429791|142982146|OTHER|||||||0.001||||||P-value for interaction between treatment group and baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
71733415|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.724|||<|0.001|TWO_SIDED|95.0|0.679|0.772||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.772|0.679|<.001
71733416|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.825|||<|0.001|TWO_SIDED|95.0|0.742|0.918||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.918|0.742|<.001
71733417|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.81|||<|0.001|TWO_SIDED|95.0|0.742|0.884||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.884|0.742|<.001
71733418|NCT02429791|142982146|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
71733419|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.817|||<|0.001|TWO_SIDED|95.0|0.774|0.863||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.863|0.774|<.001
71733420|NCT02429791|142982146|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
71733421|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.881|||<|0.001|TWO_SIDED|95.0|0.823|0.943||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.943|0.823|<.001
71733422|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.829||||0.001|TWO_SIDED|95.0|0.74|0.93||P value to assess difference between treatment groups (osteocalcin - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.930|0.740|0.001
71733423|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.691|||<|0.001|TWO_SIDED|95.0|0.628|0.759||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.759|0.628|<.001
71733424|NCT02429791|142982146|OTHER|||||||0.782||||||P-value for interaction between treatment group and baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
71733425|NCT02429791|142982146|SUPERIORITY||Odds Ratio (OR)|0.804|||<|0.001|TWO_SIDED|95.0|0.742|0.872||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.872|0.742|<.001
71733426|NCT02429791|142982159|OTHER|||||||0.317||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.317
71733427|NCT02429791|142982159|OTHER||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.7|1.5|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.5|-7.7|
71733428|NCT02429791|142982159|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-5.1|9.0|||||INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||9.0|-5.1|
71733429|NCT02429791|142982159|OTHER||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-5.3|10.8|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||10.8|-5.3|
71733430|NCT02429791|142982167|OTHER|||||||0.94||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.940
71733431|NCT02429791|142982167|SUPERIORITY||Mean Difference (Final Values)|-2.924|||<|0.001|TWO_SIDED|95.0|-4.26|-1.588||P value to assess difference between treatment groups (Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-1.588|-4.260|<.001
71733432|NCT02429791|142982167|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.001
71733433|NCT02429791|142982167|SUPERIORITY||Mean Difference (Final Values)|-1.192||||0.11|TWO_SIDED|95.0|-2.656|0.271||P value to assess difference between treatment groups (Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.271|-2.656|0.110
71733434|NCT02429791|142982167|OTHER|||||||0.048||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.048
71733435|NCT02429791|142982167|SUPERIORITY||Mean Difference (Final Values)|-1.569||||0.038|TWO_SIDED|95.0|-3.048|-0.09||P value to assess difference between treatment groups (Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.090|-3.048|0.038
71733436|NCT02429791|142982170|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.002
71733437|NCT02429791|142982170|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
71733438|NCT02429791|142982170|SUPERIORITY|||||||0.024||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.024
71733439|NCT02429791|142982170|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||<0.001
71733440|NCT02429791|142982170|SUPERIORITY||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||<0.001
71733441|NCT02429791|142982170|SUPERIORITY|||||||0.005||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.005
71733442|NCT02429791|142982170|SUPERIORITY|||||||0.063||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.063
71733443|NCT02429791|142982170|SUPERIORITY|||||||0.002||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.002
71733444|NCT02429791|142982170|SUPERIORITY|||||||0.099||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.099
71772616|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2597|TWO_SIDED|95.0|-3.19|0.88||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||0.88|-3.19|0.2597
71733445|NCT04201093|142982185|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.2|-13.8|<0.0001
71733446|NCT04201093|142982185|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-9.8|-14.4|<0.0001
71733447|NCT04201093|142982186|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.3|<0.0001
71733448|NCT04201093|142982186|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||||-1.7|-3.4|<0.0001
71733449|NCT04201093|142982187|SUPERIORITY||Odds Ratio (OR)|6.148|||<|0.0001|TWO_SIDED|95.0|3.339|11.321|||Mixed Models Analysis|||||11.321|3.339|<0.0001
71831806|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.06||0.83|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 44.2, t=-0.22|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 14.||||0.83
71889239|NCT01925209|143299850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.31|STANDARD_ERROR_OF_MEAN|14.121||0.9263|TWO_SIDED|99.0|-37.97|35.36|||mixed models repeated measures|||||35.36|-37.97|0.9263
71661214|NCT01739348|142836059|SUPERIORITY||Difference in Least Squares Means|0.5||||0.4925|TWO_SIDED|97.51|-1.1|2.1|||Longitudinal ANCOVA|||||2.1|-1.1|0.4925
71733450|NCT04201093|142982187|SUPERIORITY||Odds Ratio (OR)|5.968|||<|0.0001|TWO_SIDED|95.0|3.22|11.062|||Mixed Models Analysis|||||11.062|3.220|<0.0001
71733451|NCT04201093|142982188|SUPERIORITY||LS Mean of Difference|-11.5|STANDARD_ERROR_OF_MEAN|1.16|<|0.0001|TWO_SIDED|95.0|-13.8|-9.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.2|-13.8|<0.0001
71733452|NCT04201093|142982188|SUPERIORITY||LS Mean of Difference|-12.1|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-14.4|-9.8||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.8|-14.4|<0.0001
71733453|NCT04201093|142982189|SUPERIORITY||LS Mean of Difference|-11.7|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-14.4|-9.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.1|-14.4|<0.0001
71733454|NCT04201093|142982189|SUPERIORITY||LS Mean of Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.37|<|0.0001|TWO_SIDED|95.0|-14.7|-9.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-9.3|-14.7|<0.0001
71733455|NCT04201093|142982190|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.4822|TWO_SIDED|95.0|-1.0|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.5|-1.0|0.4822
71733456|NCT04201093|142982190|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7742|TWO_SIDED|95.0|-0.9|0.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part I: Week 26||0.6|-0.9|0.7742
71659550|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659551|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659552|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659553|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659554|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71733457|NCT04201093|142982190|SUPERIORITY||LS Mean of Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.3|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.3|<0.0001
71733458|NCT04201093|142982190|SUPERIORITY||LS Mean of Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.4|-1.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part II: Week 26||-1.7|-3.4|<0.0001
71733459|NCT04201093|142982190|SUPERIORITY||LS Mean of Difference|-9.0|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-10.8|-7.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.3|-10.8|<0.0001
71659555|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71733460|NCT04201093|142982190|SUPERIORITY||LS Mean of Difference|-9.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-11.2|-7.6||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Part III: Week 26||-7.6|-11.2|<0.0001
71733461|NCT04201093|142982191|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.3|-0.6|<0.0001
71889240|NCT01950819|143299869|NON_INFERIORITY|p vale for non inferiority margin is 10 %|Odds Ratio (OR)|3.0||||0.001|TWO_SIDED|95.0|-1.4|7.3|||Logistic Regression Model|||calculated at month 12||7.3|-1.4|0.001
71659556|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659557|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659558|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659559|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659560|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659561|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71661215|NCT01739348|142836059|SUPERIORITY||Difference in Least Squares Means|0.7||||0.3221|TWO_SIDED|97.51|-0.9|2.3|||Longitudinal ANCOVA|||||2.3|-0.9|0.3221
71733462|NCT04201093|142982191|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.5|-0.2||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.2|-0.5|<0.0001
71733463|NCT04201093|142982192|SUPERIORITY||LS Mean of Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
71733464|NCT04201093|142982192|SUPERIORITY||LS Mean of Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.7|-1.2|<0.0001
71733465|NCT04201093|142982193|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.4|<0.0001
71733466|NCT04201093|142982193|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.9|-1.5|<0.0001
71733467|NCT04201093|142982194|SUPERIORITY||LS Mean of Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.6047|TWO_SIDED|95.0|-0.8|0.5||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.5|-0.8|0.6047
71733468|NCT04201093|142982194|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.33||0.257|TWO_SIDED|95.0|-1.0|0.3||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||0.3|-1.0|0.2570
71733469|NCT04201093|142982195|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.8516|TWO_SIDED|95.0|-1.4|1.1||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.1|-1.4|0.8516
71733470|NCT04201093|142982195|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.64||0.6421|TWO_SIDED|95.0|-1.6|1.0||LS Means, SE, difference from placebo, and CI's are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, treatment by visit interaction and MAO-B inhibitor use with the baseline value as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.0|-1.6|0.6421
71733471|NCT03743064|142982279|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.284|STANDARD_ERROR_OF_MEAN|0.289|<|0.0001|TWO_SIDED|95.0|0.718|1.851|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MWp H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.851|0.718|<0.0001
71733472|NCT03743064|142982280|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.399||0.7241|TWO_SIDED|95.0|-0.641|0.923|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant. The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||0.923|-0.641|0.7241
71733473|NCT03743064|142982281|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.081|STANDARD_ERROR_OF_MEAN|0.579||0.0003|TWO_SIDED|95.0|0.946|3.216|||ANOVA|||||3.216|0.946|0.0003
71733474|NCT03743064|142982282|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.404|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|1.471|3.337|||ANOVA|||||3.337|1.471|<0.0001
71733475|NCT03743064|142982283|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.629|STANDARD_ERROR_OF_MEAN|0.431||0.1443|TWO_SIDED|95.0|-0.215|1.472|||ANOVA|||||1.472|-0.215|0.1443
71733476|NCT03743064|142982284|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.452||0.7376|TWO_SIDED|95.0|-0.734|1.036|||ANOVA|||||1.036|-0.734|0.7376
71659562|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659563|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659564|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659565|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659566|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659567|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659568|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659569|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659570|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659571|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659572|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659573|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659574|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659575|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659576|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659577|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659578|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71661216|NCT01739348|142836066|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8426|TWO_SIDED|97.51|-0.4|0.3|||Longitudinal ANCOVA|||||0.3|-0.4|0.8426
71733477|NCT01302054|142982300|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-2.63|-2.02||Statistical testing: one-sided, at alpha = 0.025.|t-test, 1 sided|||||-2.02|-2.63|<0.0001
71733478|NCT01302054|142982301|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0079|TWO_SIDED|95.0|-0.87|-0.13||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance \[ANCOVA\]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).||-0.13|-0.87|0.0079
71733479|NCT01302054|142982302|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0931|TWO_SIDED|95.0|-0.86|0.07||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||0.07|-0.86|0.0931
71772617|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.4852|TWO_SIDED|95.0|-2.38|1.14||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.14|-2.38|0.4852
71772618|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.4542|TWO_SIDED|95.0|-2.69|1.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.22|-2.69|0.4542
71772619|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.3061|TWO_SIDED|95.0|-3.04|0.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.97|-3.04|0.3061
71772620|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||0.3082|TWO_SIDED|95.0|-2.61|0.84||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.84|-2.61|0.3082
71772621|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.2672|TWO_SIDED|95.0|-3.09|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.87|-3.09|0.2672
71831807|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|1.2||0.52|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df =44.0, t=-0.64|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the HAMD6 change scores, reporting here information for Day 28.||||0.52
71889241|NCT01879410|143299891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA||Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.|||0.139|0.063|<0.001
71889242|NCT01756456|143299893|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|35.3|||<|0.001|TWO_SIDED|97.06|15.88|54.71|||Chi-squared|||Phase II||54.71|15.88|<0.001
71733480|NCT01302054|142982303|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0438|TWO_SIDED|95.0|-1.37|-0.02||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-0.02|-1.37|0.0438
71733481|NCT01302054|142982304|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||<0.0001
71733482|NCT01302054|142982305|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel|||||||0.0095
71659579|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|< 0.001
71733483|NCT01302054|142982306|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.34|STANDARD_ERROR_OF_MEAN|1.91||0.0001|TWO_SIDED|95.0|-11.1|-3.58||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||-3.58|-11.10|0.0001
71733484|NCT01302054|142982307|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|9.01|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|5.12|12.91||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||12.91|5.12|<0.0001
71733485|NCT01302054|142982307|SUPERIORITY_OR_OTHER||LS Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|3.87|11.62||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||11.62|3.87|<0.0001
71733486|NCT01302054|142982307|SUPERIORITY_OR_OTHER||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|2.0||0.0012|TWO_SIDED|95.0|2.6|10.45||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.45|2.60|0.0012
71733487|NCT01302054|142982307|SUPERIORITY_OR_OTHER||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|1.64||0.0123|TWO_SIDED|95.0|0.9|7.36||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||7.36|0.90|0.0123
71659580|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659581|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001||95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.00|45.24|< 0.001
71659582|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71733488|NCT01302054|142982307|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|1.77|<|0.0001|TWO_SIDED|95.0|3.63|10.57||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.||10.57|3.63|<0.0001
71733489|NCT01302054|142982308|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0023
71733490|NCT01302054|142982309|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0027
71733491|NCT01302054|142982310|SUPERIORITY_OR_OTHER|||||||0.0427|TWO_SIDED|||||Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.0427
71733492|NCT01302054|142982310|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED|||||Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel|||||||0.1461
71733493|NCT02809053|142982311|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate (%)|-4.2|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.8|6.35|||||Comparison: SAIT101 versus MabThera.|Adjusted Difference Rate (%) in Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 28.||6.35|-14.80|
71772622|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.11||||0.0427|TWO_SIDED|95.0|-4.15|-0.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.07|-4.15|0.0427
71772623|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0716|TWO_SIDED|95.0|-3.37|0.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||0.15|-3.37|0.0716
71772624|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.7184|TWO_SIDED|95.0|-2.09|3.0||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.00|-2.09|0.7184
71659583|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|< 0.001
71659584|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||64.09|37.39|<0.001
71659585|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659586|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||16.97|-1.15|0.087
71659587|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659588|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659589|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71733494|NCT02809053|142982312|OTHER|The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).|Adjusted Difference Rate|-10.3|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-20.92|0.61|||||Comparison: SAIT101 versus MabThera|Adjusted Difference Rate of Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 12.||0.61|-20.92|
71733495|NCT02809053|142982317|OTHER|The estimated Hazard Ratio with 95% CI was obtained from Cox regression model; however, stratification factors, ie, FLIPI-2 (low, intermediate and high risk), were only taken into account if FLIPI-2 score=all.|Hazard Ratio (HR)|1.724|||||TWO_SIDED|95.0|0.853|3.482|||||Hazard Ration of TTE SAIT101:MabThera|Time to Event (TTE) Hazard Ratio (HR) of SAIT101:MabThera. The TTE is defined as the time from the date of randomization to the date when an event occurs; an event is disease progression as assessed by Investigator, death due to any cause, or the start of new treatment, whichever comes first.||3.482|0.853|
71659590|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659591|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659592|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659593|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659594|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71659595|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71659596|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71661217|NCT01739348|142836066|SUPERIORITY||Difference in Least Squares Means|0.0||||0.8264|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA|||||0.4|-0.3|0.8264
71661218|NCT01739348|142836067|SUPERIORITY||Difference in Least Squares Means|-0.6||||0.0005|TWO_SIDED|97.51|-1.0|-0.2|||Longitudinal ANCOVA|||||-0.2|-1.0|0.0005
71761230|NCT00611026|143024045|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71659597|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659598|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659599|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.12|||<|0.001|TWO_SIDED|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.00|45.24|<0.001
71659600|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.23||||0.071|TWO_SIDED|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.10|-0.63|0.071
71733496|NCT02809053|142982318|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|101.39|||||TWO_SIDED|90.0|95.86|107.24|||||Comparison: SAIT101 versus MabThera. Equivalence was demonstrated for SAIT101 and MabThera with exposure pharmacokinetic parameter AUC0-168,w1 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) (%) of SAIT101 versus MabThera Area Under the Concentration time Curve Day 0 to Week 1 (AUC0-168,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||107.24|95.86|
71733497|NCT02809053|142982318|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Difference (%)|96.92|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter AUC0-168,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) %) of SAIT101 versus MabThera Area Under the Concentration time Cure Day 0 to Week 4 (AUC0-168,w4) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
71831808|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.19||0.11|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df = 31.0, t=1.67|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 2.||||0.11
71831809|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.98|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=41.1, t=-0.03|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 14.||||0.98
71659601|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.12|||<|0.001|TWO_SIDED|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.69|6.55|<0.001
71889243|NCT01756456|143299893|SUPERIORITY|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 \[Yes/No\]).|Difference in percentage|38.4|||=|0.001|TWO_SIDED|97.06|18.96|57.83|||Chi-squared|||||57.83|18.96|=0.001
71659602|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659603|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659604|NCT02912650|142833434|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659605|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.156|TWO_SIDED|95.0|-0.44|2.75|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.75|-0.44|0.156
71659606|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.16||||0.155|TWO_SIDED|95.0|-0.44|2.76|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||2.76|-0.44|0.155
71733498|NCT02809053|142982319|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00|GLS Mean Ratio (%)|99.35|||||TWO_SIDED|90.0|90.85|103.4|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with Cmax,w1 exposure within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 1 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.||103.40|90.85|
71733499|NCT02809053|142982319|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ration (%)|99.23|||||TWO_SIDED|90.0|92.96|105.92|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Cmax,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 4 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||105.92|92.96|
71733500|NCT02809053|142982322|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%).|GLS Mean Ratio (%)|95.45|||||TWO_SIDED|90.0|88.85|102.55|||||Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Ctrough,d29 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).|Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera trough plasma concentration at the end of the dosing period (Day 29) (Ctrough,d29) (µg/mL) . The statistical comparison of the log-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment||102.55|88.85|
71733501|NCT02809053|142982326|OTHER||Mean Difference (Final Values)|7.2|||||TWO_SIDED|90.0|-31.0|45.4|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 1 (AUEC0-168,w1), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||45.4|-31.0|
71733502|NCT02809053|142982326|OTHER||Mean Difference (Final Values)|18.0|||||TWO_SIDED|90.0|-21.6|57.6|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 2 (AUEC0-168,w2), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||57.6|-21.6|
71733503|NCT02809053|142982326|OTHER||Mean Difference (Final Values)|21.4|||||TWO_SIDED|90.0|-18.3|61.0|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 3 (AUEC0-168,w3), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||61.0|-18.3|
71733504|NCT02809053|142982326|OTHER||Mean Difference (Final Values)|20.4|||||TWO_SIDED|90.0|-19.3|60.2|||||comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 4 (AUEC0-168,w4), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||60.2|-19.3|
71733505|NCT02809053|142982326|OTHER||Mean Difference (Final Values)|15.7|||||TWO_SIDED|90.0|-23.1|54.6|||||Comparison: SAIT101 versus MabThera|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 12 (AUEC0-168,w12), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||54.6|-23.1|
71733506|NCT02809053|142982326|OTHER||Mean Difference (Final Values)|12.8|||||TWO_SIDED|90.0|-26.0|51.8|||||Comparison: SAIT101 versus MabThera.|Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 28 (AUEC0-168,w28), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||51.8|-26.0|
71733507|NCT02809053|142982330|OTHER|||||||0.587||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis: Comparison of Overall Response Rate (ORR) by Region (European Union / Other). The interaction p-value for the Region subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.587
71733508|NCT02809053|142982330|OTHER|||||||0.421||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Overall Response Rate by Age Group (18-60 years and \>60 years). The interaction p-value for the Age subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.421
71733509|NCT02809053|142982330|OTHER|||||||0.288||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Simon|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Gender (Male / Female). The interaction p-value for the Gender subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate. The p-value was calculated using Gail-Simon Test for Qualitative Interactions.||||0.288
71733510|NCT02809053|142982330|OTHER|||||||0.588||||||The p-value was calculated using Gail-Simon Test for Qualitative Interactions.|Gail-Wilson|||Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Anti-drug Antibody (ADA) status (Positive / Negative). The interaction p-value for the ADA subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.||||0.588
71733511|NCT01852383|142982338|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
71733512|NCT01852383|142982339|SUPERIORITY_OR_OTHER||||||<|0.1||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|Corrlation|||||||<0.1
71733513|NCT01852383|142982340|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA|||||||<0.001
71733514|NCT01852383|142982341|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.|Pearson correlation|||Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.||||<.001
71733515|NCT01300455|142982364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66|||||TWO_SIDED|90.0|0.22|5.09|||Difference of the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||5.09|0.22|
71733516|NCT01300455|142982367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|90.0|-0.49|0.42|||Difference in the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||0.42|-0.49|
71733517|NCT01300455|142982367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.45|0.33|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||0.33|-0.45|
71733518|NCT01300455|142982368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|90.0|-1.31|2.79|||Difference in the Least Squares Means|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||2.79|-1.31|
71733519|NCT01300455|142982368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.1|0.59|||Difference in the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.59|-0.10|
71733520|NCT01300455|142982368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.59|1.01|||Difference in the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||1.01|-0.59|
71772625|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.7004|TWO_SIDED|95.0|-2.06|3.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||3.03|-2.06|0.7004
71772626|NCT01227564|143045007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.6723|TWO_SIDED|95.0|-1.77|2.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.71|-1.77|0.6723
71889244|NCT01756456|143299894|SUPERIORITY||Difference in percentage|25.8|||=|0.016|TWO_SIDED|97.06|3.66|47.87|||Chi-squared|||||47.87|3.66|=0.016
71889245|NCT01756456|143299894|SUPERIORITY||Difference in percentage|34.7|||=|0.002|TWO_SIDED|97.06|11.91|57.41|||Chi-squared|||||57.41|11.91|=0.002
71733521|NCT01300455|142982368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.09|0.65|||Difference in the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.65|-0.09|
71733522|NCT01300455|142982369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|90.0|-0.61|0.49|||Difference of Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.49|-0.61|
71733523|NCT01300455|142982369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.41|0.5|||Difference of the Least Sqares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.41|
71733524|NCT01300455|142982369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.13|0.1|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.10|-1.13|
71733525|NCT01300455|142982369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||||TWO_SIDED|90.0|-0.24|0.5|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.24|
71733526|NCT01300455|142982369|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02|||||TWO_SIDED|90.0|-0.4|0.43|||Difference in the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.43|-0.40|
71733527|NCT01300455|142982369|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.18|||||TWO_SIDED|90.0|-0.61|0.25|||Difference in the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.25|-0.61|
71733528|NCT01300455|142982370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|90.0|-3.2|2.26|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||2.26|-3.20|
71733529|NCT02228096|142982493|OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
71733530|NCT01304589|142982617|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
71733531|NCT01304589|142982618|SUPERIORITY_OR_OTHER|||||||0.003||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|paired T-test|"Subjects completed a tampon insertion pain test once a week. The values were averaged and compared pre-treatment versus post-treatment."||||||.003
71889246|NCT01756456|143299895|SUPERIORITY||difference in percentage|2.4|||=|0.818|TWO_SIDED|97.06|-20.3|25.08|||Chi-squared|||At week 6 - reading center||25.08|-20.30|=0.818
71889247|NCT01756456|143299895|SUPERIORITY||difference in percentage|-6.3|||=|0.571|TWO_SIDED|97.06|-30.62|17.96|||Chi-squared|||at week 6 - central reading center||17.96|-30.62|=0.571
71889248|NCT01756456|143299895|SUPERIORITY||Difference in percentage|20.3|||=|0.064|TWO_SIDED|97.06|-3.11|43.79|||Chi-squared|||week 6 - investigator||43.79|-3.11|=0.064
71772627|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9535|TWO_SIDED|95.0|-1.58|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.68|-1.58|0.9535
71772628|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9914|TWO_SIDED|95.0|-1.63|1.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.65|-1.63|0.9914
71772629|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9682|TWO_SIDED|95.0|-1.39|1.44||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||1.44|-1.39|0.9682
71772630|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.2008|TWO_SIDED|95.0|-2.96|0.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.64|-2.96|0.2008
71772631|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7988|TWO_SIDED|95.0|-2.07|1.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||1.60|-2.07|0.7988
71772632|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.7||||0.3764|TWO_SIDED|95.0|-2.27|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||0.87|-2.27|0.3764
71772633|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.4177|TWO_SIDED|95.0|-2.98|1.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.25|-2.98|0.4177
71831810|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=46.0, t=-0.76|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-S change scores, reporting here information for Day 28.||||0.45
71889249|NCT01756456|143299895|SUPERIORITY||Difference in percentage|23.1|||=|0.041|TWO_SIDED|97.06|-0.89|47.04|||Chi-squared|||week 6 - investigator||47.04|-0.89|=0.041
71889250|NCT01756456|143299895|SUPERIORITY||Difference in percentage|21.9|||=|0.031|TWO_SIDED|97.06|0.07|43.64|||Chi-squared|||week 8 - central reading center||43.64|0.07|=0.031
71889251|NCT01756456|143299895|SUPERIORITY||difference in percentage|26.9|||=|0.008|TWO_SIDED|97.06|5.57|48.28|||Chi-squared|||week 8 - central reading center||48.28|5.57|=0.008
71889252|NCT01756456|143299895|SUPERIORITY||Difference in percentage|26.1|||=|0.011|TWO_SIDED|97.06|4.18|48.01|||Chi-squared|||week 8 - investigator||48.01|4.18|=0.011
71889253|NCT01756456|143299895|SUPERIORITY||Difference in percentage|25.9|||=|0.014|TWO_SIDED|97.06|3.55|48.33|||Chi-squared|||week 8 - investigator||48.33|3.55|=0.014
71889254|NCT01756456|143299896|SUPERIORITY||difference in percentage|13.7|||=|0.065|TWO_SIDED|95.0|-0.19|27.57|||Chi-squared|||week 4||27.57|-0.19|=0.065
71889255|NCT01756456|143299896|SUPERIORITY||difference in percentage|12.4|||=|0.097|TWO_SIDED|95.0|-2.05|26.78|||Chi-squared|||week 4||26.78|-2.05|=0.097
71889256|NCT01756456|143299896|SUPERIORITY||difference in percentage|16.9|||=|0.036|TWO_SIDED|95.0|1.97|31.92|||Chi-squared|||week 6||31.92|1.97|=0.036
71659607|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.68||||0.605|TWO_SIDED|95.0|-3.27|1.9|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||1.90|-3.27|0.605
71659608|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.84||||0.079|TWO_SIDED|95.0|-0.21|3.89|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||3.89|-0.21|0.079
71659609|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-1.85||||0.078|TWO_SIDED|95.0|-3.9|0.21|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||0.21|-3.90|0.078
71659610|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.47|||<|0.001|TWO_SIDED|95.0|15.33|27.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||27.62|15.33|<0.001
71659611|NCT02912650|142833435|SUPERIORITY_OR_OTHER||Cumulative Percentage of Participants wi|7.79||||0.056|TWO_SIDED|95.0|-0.19|15.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.77|-0.19|0.056
71659612|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-0.37||||0.934|TWO_SIDED|95.0|-9.18|8.43|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||8.43|-9.18|0.934
71659613|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.67|||<|0.001|TWO_SIDED|95.0|8.58|18.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.77|8.58|<0.001
71659614|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|21.96|||<|0.001|TWO_SIDED|95.0|15.64|28.28|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||28.28|15.64|<0.001
71659615|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-8.21||||0.05|TWO_SIDED|95.0|-16.4|-0.01|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||-0.01|-16.40|0.050
71659616|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|55.89|||<|0.001|TWO_SIDED|95.0|47.05|64.73|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.73|47.05|<0.001
71772634|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.6494|TWO_SIDED|95.0|-2.67|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.68|-2.67|0.6494
71772635|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.4674|TWO_SIDED|95.0|-2.54|1.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||1.18|-2.54|0.4674
71772636|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.4709|TWO_SIDED|95.0|-3.85|1.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||1.81|-3.85|0.4709
71661219|NCT01739348|142836067|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.0002|TWO_SIDED|97.51|-1.1|-0.3|||Longitudinal ANCOVA|||||-0.3|-1.1|0.0002
71772637|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.4128|TWO_SIDED|95.0|-1.7|4.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||4.07|-1.70|0.4128
71889257|NCT01756456|143299896|SUPERIORITY||difference in percentage|15.6|||=|0.054|TWO_SIDED|95.0|0.04|31.12|||Chi-squared|||week 6||31.12|0.04|=0.054
71889258|NCT01756456|143299896|SUPERIORITY||difference in percentage|17.1|||=|0.043|TWO_SIDED|95.0|1.45|32.72|||Chi-squared|||week 8||32.72|1.45|=0.043
71659617|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|12.99||||0.015|TWO_SIDED|95.0|2.5|23.49|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.49|2.50|0.015
71733532|NCT01304589|142982619|SUPERIORITY_OR_OTHER|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||.001
71733533|NCT01304589|142982620|SUPERIORITY_OR_OTHER||||||<|0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided|||||||<.001
71733534|NCT00279812|142982623|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71733535|NCT00279812|142982624|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71733536|NCT00279812|142982625|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71772638|NCT01227564|143045008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.9478|TWO_SIDED|95.0|-2.41|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||2.58|-2.41|0.9478
71772639|NCT01227564|143045009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.7146|TWO_SIDED|95.0|-3.4|2.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||2.35|-3.40|0.7146
71772640|NCT01227564|143045009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||0.2733|TWO_SIDED|95.0|-4.6|1.33||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.33|-4.60|0.2733
71889259|NCT01756456|143299896|SUPERIORITY||difference in percentage|11.4|||=|0.157|TWO_SIDED|95.0|-4.08|26.93|||Chi-squared|||week 8||26.93|-4.08|=0.157
71889260|NCT01756456|143299897|SUPERIORITY||least square mean difference|8.9|||=|0.022|TWO_SIDED|95.0|1.33|16.5|||ANCOVA|||||16.50|1.33|=0.022
71889261|NCT01756456|143299897|SUPERIORITY||least square mean difference|5.0|||=|0.213|TWO_SIDED|95.0|-2.9|12.88|||ANCOVA|||||12.88|-2.90|=0.213
71659618|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.16||||0.188|TWO_SIDED|95.0|-3.51|17.82|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.82|-3.51|0.188
71733537|NCT01439373|142982670|OTHER||Mean posterior difference|0.46|STANDARD_DEVIATION|0.119|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.905. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.22 to 0.68.|||||
71733538|NCT01439373|142982671|OTHER||Mean posterior difference|0.41|STANDARD_DEVIATION|0.122|||||||||Bayesian probability model|"P1= P(p805 \>pPLC +0.3 \| data)= 0.822. A probability of 95% (P1 \> 0.95) or greater was to be considered 'substantial evidence of superiority."|Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.17 to 0.6|||||
71733539|NCT03281304|142982689|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|0.5|25.0||||||Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.0|0.5|
71733540|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
71733541|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
71733542|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.9|25.2||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|2.9|
71733543|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
71733544|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
71733545|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
71889262|NCT01756456|143299898|SUPERIORITY||difference in percentage|5.5|||=|0.592|TWO_SIDED|95.0|-14.53|25.48|||Chi-squared|||week 4||25.48|-14.53|=0.592
71659619|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.61|||<|0.001|TWO_SIDED|95.0|33.85|51.38|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||51.38|33.85|<0.001
71733546|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|-0.7|28.5||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.5|-0.7|
71733547|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
71733548|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.3|20.4||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.4|-9.3|
71733549|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|8.6|||||TWO_SIDED|95.0|-7.0|23.6||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.6|-7.0|
71733550|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.8|18.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.3|-12.8|
71733551|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
71733552|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
71733553|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|-4.3|||||TWO_SIDED|95.0|-20.2|11.9||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||11.9|-20.2|
71733554|NCT03281304|142982691|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.7|19.9||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.9|-11.7|
71831811|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=49.2, t=2.39;|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 2.||||0.02
71889263|NCT01756456|143299898|SUPERIORITY|week 4|difference in percentage|-2.3|||=|0.835|TWO_SIDED|95.0|-24.01|19.4|||Chi-squared|||||19.40|-24.01|=0.835
71733555|NCT03281304|142982692|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-1.5|24.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||24.1|-1.5|
71733556|NCT03281304|142982692|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|3.6|35.0||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||35.0|3.6|
71733557|NCT03281304|142982692|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
71733558|NCT03281304|142982692|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-12.5|18.0||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.0|-12.5|
71889264|NCT01756456|143299898|SUPERIORITY||difference in percentage|27.7|||=|0.008|TWO_SIDED|95.0|8.1|47.22|||Chi-squared|||week 6||47.22|8.10|=0.008
71889265|NCT01756456|143299898|SUPERIORITY||difference in percentage|12.4|||=|0.282|TWO_SIDED|95.0|-9.91|34.68|||Chi-squared|||week 6||34.68|-9.91|=0.282
71889266|NCT01756456|143299898|SUPERIORITY||difference in percentage|10.2|||=|0.303|TWO_SIDED|95.0|-9.15|29.45|||Chi-squared|||||29.45|-9.15|=0.303
71659620|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|48.58|||<|0.001|TWO_SIDED|95.0|39.63|57.54|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.54|39.63|<0.001
71661220|NCT01739348|142836068|SUPERIORITY||Ratio of Fold Change from Baseline|0.95||||0.2138|TWO_SIDED|95.0|0.87|1.04|||Longitudinal ANCOVA|||||1.04|0.87|0.2138
71733559|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-7.5|13.4||||||Month 1: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.4|-7.5|
71733560|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|0.1|22.8||||||Month 3: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.8|0.1|
71733561|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|2.4|25.6||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.6|2.4|
71733562|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|20.0|||||TWO_SIDED|95.0|8.0|31.8||||||Month 9: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||31.8|8.0|
71733563|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|2.2|28.7||||||Month 12: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.7|2.2|
71733564|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|14.3|||||TWO_SIDED|95.0|0.0|27.9||||||Month 15: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||27.9|0.0|
71733565|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|0.7|29.9||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||29.9|0.7|
71733566|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|5.7|||||TWO_SIDED|95.0|-9.5|20.6||||||Month 21: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||20.6|-9.5|
71733567|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|7.1|||||TWO_SIDED|95.0|-8.0|21.9||||||Month 24: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||21.9|-8.0|
71733568|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.7|25.1||||||Month 27: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.1|-5.7|
71733569|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|4.3|||||TWO_SIDED|95.0|-11.4|19.7||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||19.7|-11.4|
71733570|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.4|17.2||||||Month 33: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||17.2|-14.4|
71733571|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 36: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
71733572|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|-2.9|||||TWO_SIDED|95.0|-18.8|13.3||||||Month 39: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||13.3|-18.8|
71733573|NCT03281304|142982693|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
71733574|NCT03281304|142982694|OTHER||Adjusted (weighted) difference|15.7|||||TWO_SIDED|95.0|-0.4|30.8||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||30.8|-0.4|
71733575|NCT03281304|142982694|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.5|28.3||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.3|-3.5|
71733576|NCT03281304|142982694|OTHER||Adjusted (weighted) difference|1.4|||||TWO_SIDED|95.0|-14.0|16.7||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.7|-14.0|
71733577|NCT03281304|142982695|OTHER||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||||0.1|-0.8|
71772641|NCT01227564|143045009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3969|TWO_SIDED|95.0|-3.62|1.46||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.||1.46|-3.62|0.3969
71772642|NCT01227564|143045009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.8566|TWO_SIDED|95.0|-2.43|2.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||2.92|-2.43|0.8566
71733578|NCT03281304|142982697|OTHER||Least Squares (LS) Mean Difference|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Month 1||0.3|-0.1|
71733579|NCT03281304|142982697|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||Month 3||0.2|-0.2|
71733580|NCT03281304|142982697|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Month 6||0.3|-0.2|
71733581|NCT03281304|142982699|OTHER||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.2|0.1||||||||0.1|-1.2|
71733582|NCT03281304|142982701|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 1||0.3|-0.3|
71889267|NCT01756456|143299898|SUPERIORITY||difference in percentage|7.9|||=|0.442|TWO_SIDED|95.0|-12.13|27.92|||Chi-squared|||week 8||27.92|-12.13|=0.442
71889268|NCT01756456|143299899|SUPERIORITY||difference in percentage|-2.6|||=|0.597|TWO_SIDED|95.0|-22.87|17.71|||Chi-squared|||week 4||17.71|-22.87|=0.597
71889269|NCT01756456|143299899|SUPERIORITY||difference in percentage|-2.3|||>|0.999|TWO_SIDED|95.0|-23.26|18.71|||Chi-squared|||week 4||18.71|-23.26|>0.999
71733583|NCT03281304|142982701|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2||||||Month 3||0.2|-0.3|
71733584|NCT03281304|142982701|OTHER||LS Mean Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Month 6||0.3|-0.3|
71733585|NCT03281304|142982703|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-0.3|23.1||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||23.1|-0.3|
71733586|NCT03281304|142982703|OTHER||Adjusted (weighted) difference|18.6|||||TWO_SIDED|95.0|3.5|32.6||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||32.6|3.5|
71733587|NCT03281304|142982703|OTHER||Adjusted (weighted) difference|12.9|||||TWO_SIDED|95.0|-3.3|28.1||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||28.1|-3.3|
71733588|NCT03281304|142982703|OTHER||Adjusted (weighted) difference|0.0|||||TWO_SIDED|95.0|-16.1|16.1||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||16.1|-16.1|
71889270|NCT01756456|143299899|SUPERIORITY||difference in percentage|-7.8|||=|0.183|TWO_SIDED|95.0|-28.7|13.76|||Chi-squared|||week 6||13.76|-28.70|=0.183
71889271|NCT01756456|143299899|SUPERIORITY||difference in percentage|-10.0|||=|0.116|TWO_SIDED|95.0|-31.41|11.88|||Chi-squared|||week 6||11.88|-31.41|=0.116
71733589|NCT03281304|142982704|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|1.3|22.0||||||Month 6: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||22.0|1.3|
71733590|NCT03281304|142982704|OTHER||Adjusted (weighted) difference|11.4|||||TWO_SIDED|95.0|-4.2|26.4||||||Month 18: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||26.4|-4.2|
71733591|NCT03281304|142982704|OTHER||Adjusted (weighted) difference|10.0|||||TWO_SIDED|95.0|-5.8|25.2||||||Month 30: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||25.2|-5.8|
71733592|NCT03281304|142982704|OTHER||Adjusted (weighted) difference|2.9|||||TWO_SIDED|95.0|-13.0|18.5||||||Month 42: Adjusted (weighted) difference and its 95% CI based on normal approximation for the difference in binomial proportions.||18.5|-13.0|
71733593|NCT02020408|142982731|SUPERIORITY||||||>|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|ANOVA|||||||> 0.05
71733594|NCT02020408|142982732|SUPERIORITY||||||<|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|General Linear Model|||A General Linear Model using log(\[11C\]raclopride BPND) after amphetamine administration as dependent variable and Diagnostic Group as independent variable was used. Baseline (before amphetamine administration) \[11C\]raclopride BPND was used as covariate.||||<0.05
71733595|NCT02100969|142982734|SUPERIORITY||"proportion of successes"|0.864||||0.0179|TWO_SIDED|95.0|0.72|1.0||No adjustment is required as we are not doing multiple comparisons for the primary outcome analyses.|One sample Z test of proportions||One sample Z test of proportions is used. Method of handling missing data (as per protocol) is Last Observation Carried Forward (LOCF). Only 2 participants had missing values and in our case the LOCF results reflect a 'best-case' scenario.|"Sample size/power calculations are mentioned in the study protocol.~The study hypotheses are as follows:~H0: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase \> 0.65"||1.000|0.720|0.0179
71733596|NCT02100969|142982735|SUPERIORITY||Median Difference (Net)|0.0||||0.113|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed rank test statistic is 44.50.|||||0.113
71733597|NCT02100969|142982736|SUPERIORITY||Median Difference (Net)|6.0||||0.612|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.612
71733598|NCT02100969|142982737|SUPERIORITY||Median Difference (Net)|2.0||||0.047|TWO_SIDED||||||Wilcoxon Signed Rank for paired data||The value of the signed-rank test statistic is 53.|||||0.047
71831812|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=56.8, t=1.85|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 14.||||0.07
71831813|NCT03149991|143168150|SUPERIORITY|We used contrast tests comparing brexpiprazole and placebo on the a priori specified days of interest. This model contains an interaction effect with site, because the SITE\*DRUG effect was significant (p=0.03).|Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.41||0.37|TWO_SIDED|||||Because these tests were conducted for secondary outcomes, p-values were not corrected for multiple testing.|Mixed Models Analysis||df=50.5, t=0.91|The same model building approach as used for the primary outcome variable was used for the secondary outcome variables. As per the primary outcome variable, the change scores (i.e., compared to baseline) were the dependent variables of interest. For each secondary outcome variable, non-significant site interaction effects were removed one at a time. This analysis is for the CGI-I change scores, reporting here information for Day 28.||||0.37
71831814|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in terms of occurrence of abnormal ECGs.|Chi-squared test|0.28||||0.6|TWO_SIDED||||||Chi-squared|||This analysis was to assess group differences (drug vs. placebo) in terms of number of abnormal ECGs out of total ECGs assessed.||||0.60
71831815|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at baseline.|Chi-squared test|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at baseline.||||0.33
71831816|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 4.|Chi-squared test|0.0||||1|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 4.||||1.00
71831817|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 5.|Chi-squared test|0.08||||0.78|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 5.||||0.78
71831818|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 6.|Chi-squared test|0.02||||0.9|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 6.||||0.90
71831819|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 7.|Chi-squared test|0.63||||0.43|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 7.||||0.43
71889272|NCT01756456|143299899|SUPERIORITY||difference in percentage|-10.8|||=|0.134|TWO_SIDED|95.0|-31.3|10.35|||Chi-squared|||week 8||10.35|-31.30|=0.134
71733599|NCT02100969|142982738|SUPERIORITY||Median Difference (Net)|5.6||||0.901|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.901
71661221|NCT01739348|142836068|SUPERIORITY||Ratio of Fold Change from Baseline|0.97||||0.433|TWO_SIDED|95.0|0.9|1.05|||Longitudinal ANCOVA|||||1.05|0.90|0.4330
71733600|NCT02100969|142982739|SUPERIORITY||Median Difference (Net)|4.2||||0.51|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.510
71733601|NCT02100969|142982740|SUPERIORITY||Median Difference (Net)|8.3||||0.289|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.289
71733602|NCT02100969|142982741|SUPERIORITY||Median Difference (Net)|715.0||||0.0028|TWO_SIDED||||||Wilcoxon Signed Rank for paired data|||||||0.0028
71733603|NCT06359080|142982745|EQUIVALENCE|The difference between post treatment CARS scores and pre treatment CARS scores will be statistically significant as measured by independent sample t-test with p\<.05|Mean Difference (Net)|6.77|STANDARD_DEVIATION|5.5|<|0.05|TWO_SIDED|95.0|5.36|8.19||It's a calculated p-value.|t-test, 2 sided|||||8.19|5.36|<0.05
71733604|NCT01364740|142982772|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71733605|NCT01364740|142982773|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71733606|NCT01364740|142982774|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71733607|NCT01364740|142982775|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data||||>0.05
71733608|NCT01023672|142982798|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||The analysis was done per protocol (n=17)||||0.003
71733609|NCT00448747|142982802|OTHER||ROC AUC|0.923|||||ONE_SIDED|99.0|0.85|||||||Summary of ROC Analyses following macimorelin administration.|||0.850|
71772643|NCT01227564|143045009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.346|TWO_SIDED|95.0|-3.98|1.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.42|-3.98|0.3460
71772644|NCT01227564|143045009|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.52||||0.6582|TWO_SIDED|95.0|-2.86|1.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.||1.82|-2.86|0.6582
71772645|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.7537|TWO_SIDED|95.0|-18.36|13.36||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||13.36|-18.36|0.7537
71772646|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.51||||0.1266|TWO_SIDED|95.0|-28.86|3.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||3.65|-28.86|0.1266
71831820|NCT03149991|143168154|EQUIVALENCE|The hypothesis was that there would be no group differences in number/percentage of people with an abnormal ECG at Visit 9.|Chi-squared test|0.09||||0.76|TWO_SIDED||||||Chi-squared|||This analysis was to assess for group differences (drug vs. placebo) in number/percentage of people with an abnormal ECG at Visit 9.||||0.76
71831821|NCT03149991|143168156|EQUIVALENCE|The hypothesis was that there would be no group differences in number of participants reporting adverse events.|Chi-squared test|0.009||||0.92|TWO_SIDED||||||Chi-squared|||This analysis assessed group differences (drug vs. placebo) in terms of number of participants reporting adverse events.||||0.92
71733610|NCT00448747|142982802|OTHER|Sensitivity|sensitivity (percent)|82.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
71831822|NCT03149991|143168157|EQUIVALENCE|The hypothesis was that there would be no difference between the groups in terms of mean number of adverse events per person, among those who reported any adverse events.|Mean Difference (Final Values)|0.24||||0.81|TWO_SIDED||||||t-test, 2 sided|||This analysis assessed group differences (drug vs. placebo) in terms of mean number of adverse events per person, among those who reported any adverse events.||||0.81
71733611|NCT00448747|142982802|OTHER|Specificity|Specificity (percent)|92.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
71733612|NCT00448747|142982802|OTHER|Misclassification|misclassification (percent)|13.0|||||TWO_SIDED|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.||||
71733613|NCT00448747|142982803|OTHER||Mean Difference (Final Values)|-5.1|STANDARD_DEVIATION|9.57|||TWO_SIDED|||||||||Summary of IGF-1 before and after AEZS-130 administration: post - pre differences||||
71733614|NCT00448747|142982803|OTHER||Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|16.25|||TWO_SIDED|||||||||||||
71733615|NCT02166463|142982830|SUPERIORITY|||||||0.0001|||||||Log Rank|Used a one-sided log-rank test between 2 arms||Assuming a 3-year EFS of 82% (5-year EFS of 78.4%, long term EFS of 76%) for standard arm, the study will have approximately 86% power for detecting an 8% improvement in 3-year EFS in the Bv-AVEPC arm (3-year EFS of 90%, 5-year EFS of 88.0%, long term EFS of 86.7%) in log rank test.||||0.0001
71733616|NCT01424566|142982860|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9173|TWO_SIDED|95.0|-0.42|0.38|||ANCOVA|||||0.38|-0.42|0.9173
71733617|NCT03445559|142982871|SUPERIORITY||Odds Ratio (OR)|0.54||||0.006|TWO_SIDED|95.0|0.3|0.98|||Chi-squared|||||0.98|0.30|0.006
71733618|NCT03445559|142982872|SUPERIORITY||Odds Ratio (OR)|1.36||||0.42|TWO_SIDED|95.0|0.7|2.66|||Chi-squared|||||2.66|0.70|0.42
71733619|NCT03445559|142982873|SUPERIORITY||Median Difference (Final Values)|2.7|||||TWO_SIDED|||||||||||||
71733620|NCT04676867|142982884|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71733621|NCT04676867|142982885|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
71733622|NCT04676867|142982886|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
71733623|NCT04676867|142982887|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71733624|NCT04676867|142982888|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71733625|NCT04676867|142982889|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71772647|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.96||||0.6724|TWO_SIDED|95.0|-28.34|18.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||18.41|-28.34|0.6724
71772648|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.017|TWO_SIDED|95.0|-53.89|-5.5||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||-5.50|-53.89|0.0170
71889273|NCT01756456|143299899|SUPERIORITY||difference in percentage|-7.9|||=|0.307|TWO_SIDED|95.0|-29.51|13.52|||Chi-squared|||week 8||13.52|-29.51|=0.307
71733626|NCT04676867|142982890|SUPERIORITY|||||||0.2|||||||Log Rank|||||||0.2
71733627|NCT04676867|142982891|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.2
71733628|NCT04676867|142982892|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71733629|NCT04676867|142982893|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
71733630|NCT04676867|142982894|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
71733631|NCT04676867|142982896|SUPERIORITY|||||||0.2|||||||ANOVA|||||||0.2
71733632|NCT04676867|142982897|SUPERIORITY|||||||0.2|||||||Regression, Logistic|||||||0.2
71733633|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||60.66|TWO_SIDED|95.0|0.85|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.85|60.66
71733634|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||95.21|TWO_SIDED|95.0|0.97|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|0.97|95.21
71733635|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||74.29|TWO_SIDED|95.0|0.88|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.88|74.29
71733636|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||99.48|TWO_SIDED|95.0|1.06|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|1.06|99.48
71733637|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||13.98|TWO_SIDED|95.0|0.66|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.66|13.98
71889274|NCT01756456|143299901|SUPERIORITY||Odds Ratio (OR)|2.18|||=|0.041|TWO_SIDED|95.0|1.03|4.62|||Chi-squared|||week 4||4.62|1.03|=0.041
71889275|NCT01756456|143299901|SUPERIORITY||Odds Ratio (OR)|1.95|||=|0.081|TWO_SIDED|95.0|0.92|4.11|||Chi-squared|||week 4||4.11|0.92|=0.081
71889276|NCT01756456|143299901|SUPERIORITY||Odds Ratio (OR)|2.47|||=|0.04|TWO_SIDED|95.0|1.04|5.88|||Chi-squared|||week 8||5.88|1.04|=0.040
71733638|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.28||||97.92|TWO_SIDED|95.0|1.01|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|1.01|97.92
71733639|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||80.24|TWO_SIDED|95.0|0.84|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.84|80.24
71733640|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.3||||97.79|TWO_SIDED|95.0|1.01|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|1.01|97.79
71733641|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.27|TWO_SIDED|95.0|0.81|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.81|51.27
71733642|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||90.66|TWO_SIDED|95.0|0.93|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.93|90.66
71733643|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.89|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|54.89
71733644|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.45|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.45
71733645|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.09|TWO_SIDED|95.0|0.98|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.98|94.09
71733646|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.95|TWO_SIDED|95.0|0.91|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.91|62.95
71733647|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||96.86|TWO_SIDED|95.0|0.99|1.26||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.26|0.99|96.86
71772649|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.94||||0.3196|TWO_SIDED|95.0|-92.67|30.78||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||30.78|-92.67|0.3196
71772650|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-64.97||||0.049|TWO_SIDED|95.0|-129.64|-0.31||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||-0.31|-129.64|0.0490
71831823|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared test|0.43||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) throughout the trial.||||0.51
71733648|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||94.16|TWO_SIDED|95.0|0.98|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.98|94.16
71733649|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.99|TWO_SIDED|95.0|0.86|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.86|48.99
71733650|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.51|TWO_SIDED|95.0|0.98|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.98|94.51
71733651|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||94.59|TWO_SIDED|95.0|0.97|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.97|94.59
71733652|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||61.27|TWO_SIDED|95.0|0.86|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.86|61.27
71733653|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||96.63|TWO_SIDED|95.0|0.99|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.99|96.63
71733654|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||94.02|TWO_SIDED|95.0|0.97|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.97|94.02
71889277|NCT01756456|143299901|SUPERIORITY||Odds Ratio (OR)|1.93|||=|0.132|TWO_SIDED|95.0|0.82|4.52|||Chi-squared|||week 8||4.52|0.82|=0.132
71733655|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.24|TWO_SIDED|95.0|0.87|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.87|53.24
71733656|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.84|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|70.84
71733657|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||74.15|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|74.15
71831824|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|2.85||||0.09|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Screening.||||0.09
71889278|NCT01756456|143299906|SUPERIORITY||difference in percentage|15.8|||=|0.097|TWO_SIDED|95.0|-2.36|33.97|||Chi-squared|||week 4||33.97|-2.36|=0.097
71889279|NCT01756456|143299906|SUPERIORITY||difference in percentage|13.2|||=|0.175|TWO_SIDED|95.0|-5.72|32.15|||Chi-squared|||week 4||32.15|-5.72|=0.175
71889280|NCT01756456|143299906|SUPERIORITY||difference in percentage|16.9|||=|0.105|TWO_SIDED|95.0|-3.11|37.0|||Chi-squared|||week 6||37.00|-3.11|=0.105
71831825|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.004||||0.95|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) at Baseline.||||0.95
71831826|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.005||||0.94|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 1.||||0.94
71831827|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|1.97||||0.16|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 2.||||0.16
71831828|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.44||||0.51|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 5.||||0.51
71831829|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.94||||0.33|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 8.||||0.33
71831830|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.003||||0.96|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 11.||||0.96
71831831|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.5||||0.48|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 14.||||0.48
71831832|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 17.||||0.41
71831833|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.17||||0.68|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 21.||||0.68
71831834|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 23.||||0.41
71831835|NCT03149991|143168158|EQUIVALENCE|The hypothesis was that there would be no group differences in occurrence of suicidal ideation.|Chi-squared|0.67||||0.41|TWO_SIDED||||||Chi-squared|||This analysis was to compare by group (drug vs. placebo) the occurrence of suicidal ideation (endorsement of item 1 on the CHRT) on Day 28.||||0.41
71831836|NCT03546608|143168159|OTHER||Ratio of Geometric Least Square Mean (%)|94.99|||||TWO_SIDED|90.0|64.75|139.35||||||||139.35|64.75|
71831837|NCT03546608|143168159|OTHER||Ratio of Geometric Least Square Mean (%)|87.92|||||TWO_SIDED|90.0|59.93|128.98||||||||128.98|59.93|
71831838|NCT03546608|143168160|OTHER||Ratio of Geometric Least Square Mean (%)|94.81|||||TWO_SIDED|90.0|64.09|140.26||||||||140.26|64.09|
71831839|NCT03546608|143168160|OTHER||Ratio of Geometric Least Square Mean (%)|87.2|||||TWO_SIDED|90.0|58.94|129.0||||||||129.00|58.94|
71831840|NCT03546608|143168161|OTHER||Ratio of Geometric Least Square Mean (%)|102.45|||||TWO_SIDED|90.0|80.9|129.73||||||||129.73|80.90|
71831841|NCT03546608|143168161|OTHER||Ratio of Geometric Least Square Mean (%)|71.02|||||TWO_SIDED|90.0|56.08|89.93||||||||89.93|56.08|
71831842|NCT03546608|143168172|OTHER||Ratio of Geometric Least Square Mean (%)|82.62|||||TWO_SIDED|90.0|45.67|149.47|||||For MSC2571109|||149.47|45.67|
71831843|NCT03546608|143168172|OTHER||Ratio of Geometric Least Square Mean (%)|136.59|||||TWO_SIDED|90.0|75.5|247.12|||||For MSC2571109|||247.12|75.50|
71831844|NCT03546608|143168172|OTHER||Ratio of Geometric Least Square Mean (%)|100.47|||||TWO_SIDED|90.0|54.53|185.1|||||For MSC2571107|||185.10|54.53|
71831845|NCT03546608|143168172|OTHER||Ratio of Geometric Least Square Mean (%)|94.48|||||TWO_SIDED|90.0|51.28|174.07|||||For MSC2571107|||174.07|51.28|
71831846|NCT03546608|143168173|OTHER||Ratio of Geometric Least Square Mean (%)|82.35|||||TWO_SIDED|90.0|45.56|148.84|||||For MSC2571109|||148.84|45.56|
71831847|NCT03546608|143168173|OTHER||Ratio of Geometric Least Square Mean (%)|137.51|||||TWO_SIDED|90.0|76.08|248.54|||||For MSC2571109|||248.54|76.08|
71831848|NCT03546608|143168173|OTHER||Ratio of Geometric Least Square Mean (%)|100.81|||||TWO_SIDED|90.0|55.16|184.23|||||For MSC2571107|||184.23|55.16|
71831849|NCT03546608|143168173|OTHER||Ratio of Geometric Least Square Mean (%)|96.18|||||TWO_SIDED|90.0|52.63|175.78|||||For MSC2571107|||175.78|52.63|
71661222|NCT01739348|142836069|SUPERIORITY||Difference in Least Squares Means|-0.03||||0.0066|TWO_SIDED|95.0|-0.05|0.0|||Longitudinal ANCOVA|||||0.00|-0.05|0.0066
71831850|NCT03546608|143168174|OTHER||Ratio of Geometric Least Square Mean (%)|92.3|||||TWO_SIDED|90.0|62.52|136.26|||||For MSC2571109|||136.26|62.52|
71831851|NCT03546608|143168174|OTHER||Ratio of Geometric Least Square Mean (%)|114.8|||||TWO_SIDED|90.0|77.76|169.48|||||For MSC2571109|||169.48|77.76|
71831852|NCT03546608|143168174|OTHER||Ratio of Geometric Least Square Mean (%)|106.51|||||TWO_SIDED|90.0|70.25|161.49|||||For MSC2571107|||161.49|70.25|
71831853|NCT03546608|143168174|OTHER||Ratio of Geometric Least Square Mean (%)|72.58|||||TWO_SIDED|90.0|47.87|110.04|||||For MSC2571107|||110.04|47.87|
71831854|NCT00130117|143168213|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
71831855|NCT00130117|143168213|SUPERIORITY|||||||0.049|||||||ANOVA|||||||0.049
71831856|NCT00130117|143168214|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.02|TWO_SIDED|||||"p value reflects treatment of leptin for on-treatment, n=4"|ANOVA|||||||0.02
71889281|NCT01756456|143299906|SUPERIORITY||difference in percentage|11.0|||=|0.3|TWO_SIDED|95.0|-9.64|31.57|||Chi-squared|||week 6||31.57|-9.64|=0.300
71889282|NCT01756456|143299906|SUPERIORITY||difference in percentage|27.5|||=|0.008|TWO_SIDED|95.0|8.33|46.67|||Chi-squared|||week 8||46.67|8.33|=0.008
71733658|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||65.43|TWO_SIDED|95.0|0.87|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.87|65.43
71733659|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||97.15|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|97.15
71733660|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||63.99|TWO_SIDED|95.0|0.81|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.34|0.81|63.99
71733661|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||91.99|TWO_SIDED|95.0|0.94|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.94|91.99
71733662|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.81|TWO_SIDED|95.0|0.94|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.94|76.81
71733663|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.01|TWO_SIDED|95.0|0.95|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.95|67.01
71733664|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||63.91|TWO_SIDED|95.0|0.85|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.85|63.91
71733665|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||96.47|TWO_SIDED|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.99|96.47
71733666|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||72.17|TWO_SIDED|95.0|0.93|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.93|72.17
71772651|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.2969|TWO_SIDED|95.0|-14.7|46.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||46.79|-14.70|0.2969
71772652|NCT01227564|143045011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2||||0.0973|TWO_SIDED|95.0|-57.42|5.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||5.03|-57.42|0.0973
71733667|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||74.38|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|74.38
71733668|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||53.85|TWO_SIDED|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.90|53.85
71733669|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||95.02|TWO_SIDED|95.0|0.98|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.98|95.02
71733670|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||92.27|TWO_SIDED|95.0|0.97|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.97|92.27
71733671|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||54.65|TWO_SIDED|95.0|0.88|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.88|54.65
71733672|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||87.93|TWO_SIDED|95.0|0.95|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.95|87.93
71733673|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||77.57|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|77.57
71772653|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.6653|TWO_SIDED|95.0|-7.94|5.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||5.10|-7.94|0.6653
71831857|NCT03779048|143168285|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.11||||0.24|TWO_SIDED||||||Regression, Linear|Controls for postprandial increases in GLP-1 and gastric emptying (acetaminophen tests)||||||.24
71831858|NCT03779048|143168286|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|-0.09||||0.34|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and gastric emptying (acetaminophen test)||||||.34
71772654|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.4613|TWO_SIDED|95.0|-4.2|9.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.||9.15|-4.20|0.4613
71889283|NCT01756456|143299906|SUPERIORITY||difference in percentage|19.0|||=|0.068|TWO_SIDED|95.0|-0.91|38.83|||Chi-squared|||week 8||38.83|-0.91|=0.068
71661223|NCT01739348|142836069|SUPERIORITY||Difference in Least Squares Means|-0.04|||<|0.0001|TWO_SIDED|95.0|-0.06|-0.02|||Longitudinal ANCOVA|||||-0.02|-0.06|<0.0001
71889284|NCT01649947|143299909|OTHER||Mean Difference (Net)|56.0||||0.01|TWO_SIDED|95.0|8.9|72.0|||t-test, 2 sided|||The analysis is comprised of evaluable patients who had measureable disease and received at least one cycle of therapy and had disease evaluated.||72|8.9|0.01
71889285|NCT01227967|143299930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.0||0.046|TWO_SIDED|95.0|-19.8|-0.2||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.||-0.2|-19.8|0.046
71889286|NCT01763164|143299945|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log-rank test.||0.80|0.47|< 0.001
71733674|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.07|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|77.07
71889287|NCT01763164|143299946|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.499|TWO_SIDED|95.0|0.75|1.33|||Log Rank|||Hazard ratio was obtained from the stratified unadjusted Cox model. P-value was obtained from the one-sided stratified log rank test.||1.33|0.75|0.499
71733675|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||78.42|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|78.42
71733676|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.15|TWO_SIDED|95.0|0.93|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.93|44.15
71733677|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.79|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.79
71733678|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||94.51|TWO_SIDED|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.24|0.98|94.51
71733679|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||93.16|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|93.16
71772655|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.771|TWO_SIDED|95.0|-4.18|5.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||5.61|-4.18|0.7710
71889288|NCT01763164|143299947|SUPERIORITY|||||||0.015|||||||Cochran-Mantel-Haenszel|||Confirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.015
71889289|NCT01763164|143299947|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||Confirmed ORR + Unconfirmed ORR: The p-value (2-sided) was computed from stratified Cochran-Mantel-Haenszel chi-square test statistic.||||0.002
71889290|NCT01763164|143299960|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.96|2.13|||Log Rank|||||2.13|0.96|
71733680|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||73.7|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.70
71733681|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.04|TWO_SIDED|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.96|81.04
71733682|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.58|TWO_SIDED|95.0|0.94|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.94|52.58
71733683|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||15.85|TWO_SIDED|95.0|0.86|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.86|15.85
71733684|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.69|TWO_SIDED|95.0|0.9|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.90|48.69
71733685|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.25|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|52.25
71733686|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||66.48|TWO_SIDED|95.0|0.91|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.91|66.48
71733687|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||9.12|TWO_SIDED|95.0|0.72|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.72|9.12
71733688|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||16.95|TWO_SIDED|95.0|0.78|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.78|16.95
71733689|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||0.89|TWO_SIDED|95.0|0.75|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.75|0.89
71733690|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.4|TWO_SIDED|95.0|0.86|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.86|50.40
71772656|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.02||||0.2328|TWO_SIDED|95.0|-1.99|8.04||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.||8.04|-1.99|0.2328
71772657|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3693|TWO_SIDED|95.0|-0.97|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.58|-0.97|0.3693
71772658|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.422|TWO_SIDED|95.0|-1.09|2.56||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.||2.56|-1.09|0.4220
71772659|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||0.3728|TWO_SIDED|95.0|-24.25|9.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||9.23|-24.25|0.3728
71772660|NCT01227564|143045012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07||||0.3452|TWO_SIDED|95.0|-25.05|8.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.||8.91|-25.05|0.3452
71772661|NCT00633867|143045034|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Log Rank|||||||<0.01
71889291|NCT01763164|143299963|SUPERIORITY||Hazard Ratio (HR)|2.2||||0.995|TWO_SIDED|95.0|1.19|4.06|||Log Rank|||Log-rank test and Cox PH model were stratified by American joint committee on cancer stage, prior line immunotherapy and ECOG performance status. P-value was one tailed and was based on the log-rank score test. Hazard ratio and 95% CI was based on a Wald test from Cox model.||4.06|1.19|0.995
71889292|NCT01512264|143299971|OTHER|||||||0.006|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.||||0.006
71772662|NCT00495131|143045042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80||||< 0.001
71889293|NCT01512264|143299971|OTHER|||||||0.015|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.||||0.015
71772663|NCT00744471|143045045|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.87|-0.69||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.69|-1.87|<0.001
71772664|NCT00744471|143045045|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.69|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.28|-1.1||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.10|-2.28|<0.001
71772665|NCT00744471|143045045|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.34|-1.16||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.16|-2.34|<0.001
71772666|NCT00744471|143045046|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.74|-0.61||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect.||-0.61|-1.74|<0.001
71772667|NCT00744471|143045046|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.06|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.06|<0.001
71772668|NCT00744471|143045046|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.17|-1.04||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.04|-2.17|<0.001
71772669|NCT00744471|143045047|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.51|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.13|-0.51|0.001
71772670|NCT00744471|143045047|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.25|-0.64|<0.001
71733691|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||7.44|TWO_SIDED|95.0|0.76|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.76|7.44
71772671|NCT00744471|143045047|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect.||-0.28|-0.66|<0.001
71772672|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
71772673|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
71772674|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
71772675|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.11|<0.001
71772676|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.57|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.57|<0.001
71733692|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||56.35|TWO_SIDED|95.0|0.87|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.87|56.35
71733693|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.87|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.87|4.03
71772677|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.5|-1.41||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.41|-2.50|<0.001
71831859|NCT03779048|143168287|OTHER|Regression using baseline scores to predict 4-week weight loss during the behavioral treatment run-in. Primary prediction analysis presented below was pre-specified to evaluate together postprandial satiety, postprandial increases in GLP-1 and gastric emptying (acetaminophen tests) and includes only the 125 participants from whom baseline blood samples could be obtained.|Standardized Beta coefficient|0.03||||0.78|TWO_SIDED||||||Regression, Linear|Controls for baseline postprandial satiety and postprandial change in GLP-1||||||.78
71772678|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.65|-0.53||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.65|<0.001
71772679|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.2|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.08|-2.20|<0.001
71772680|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.56|-1.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.45|-2.56|<0.001
71772681|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-2.10|<0.001
71772682|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.46|-1.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.25|-2.46|<0.001
71772683|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.57|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.37|-2.57|<0.001
71831860|NCT03779048|143168288|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.1|5.1|||Mixed Models Analysis|||||5.1|1.1|.003
71733694|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.79|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|24.79
71733695|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||77.08|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|77.08
71733696|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||23.07|TWO_SIDED|95.0|0.89|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.89|23.07
71733697|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||18.58|TWO_SIDED|95.0|0.88|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.88|18.58
71733698|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||44.94|TWO_SIDED|95.0|0.92|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.92|44.94
71733699|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||2.21|TWO_SIDED|95.0|0.8|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.80|2.21
71733700|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.09|TWO_SIDED|95.0|0.83|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.83|6.09
71772684|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.75|-0.56||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.75|<0.001
71772685|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.12|-0.92||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.92|-2.12|<0.001
71772686|NCT00744471|143045048|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.2|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.20|<0.001
71772687|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.93|-0.88||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.88|-1.93|<0.001
71772688|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.2||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.20|-2.26|<0.001
71772689|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.85|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.80|-1.85|<0.001
71772690|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.08|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.08|<0.001
71831861|NCT03779048|143168289|OTHER|Correlation between baseline postprandial hunger AUC and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
71831862|NCT03779048|143168290|OTHER|Correlation between baseline high energy density food reinforcer points earned and 4-week percent weight loss.|r|-0.1||||0.23|TWO_SIDED||||||Regression, Linear|||||||.23
71831863|NCT03779048|143168291|OTHER|Regression results using baseline AUC for delay discounting to predict 4-week percent weight loss, controlling for participant age.|r2 change|0.033||||0.033|TWO_SIDED||||||Regression, Linear|||||||.033
71733701|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||66.6|TWO_SIDED|95.0|0.92|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.92|66.60
71733702|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||3.23|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.23
71733703|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||20.83|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|20.83
71733704|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.6|TWO_SIDED|95.0|0.96|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.96|87.60
71733705|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||7.9|TWO_SIDED|95.0|0.84|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.84|7.90
71733706|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.39|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.39
71733707|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||76.16|TWO_SIDED|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.95|76.16
71733708|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||22.54|TWO_SIDED|95.0|0.87|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.87|22.54
71733709|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||58.17|TWO_SIDED|95.0|0.91|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.91|58.17
71772691|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.52|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.46|-2.52|<0.001
71772692|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.54|-1.48||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.48|-2.54|<0.001
71772693|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.71|-0.63||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.63|-1.71|<0.001
71772694|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.21|-1.12||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.12|-2.21|<0.001
71772695|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.6|-1.52||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.52|-2.60|<0.001
71733710|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||6.22|TWO_SIDED|95.0|0.76|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.76|6.22
71733711|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.85|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.85
71772696|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.11|-0.99||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.99|-2.11|<0.001
71772697|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.45|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.32|-2.45|<0.001
71772698|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.26|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.82|-1.7||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.70|-2.82|<0.001
71772699|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.82|-0.71||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.71|-1.82|<0.001
71772700|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.15|-1.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.03|-2.15|<0.001
71772701|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.51|-1.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.40|-2.51|<0.001
71772702|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.85|-0.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.85|<0.001
71772703|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.15|-1.01||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.01|-2.15|<0.001
71772704|NCT00744471|143045049|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.4|-1.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.27|-2.40|<0.001
71772705|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
71772706|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
71772707|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
71772708|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.12|-1.08||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.12|<0.001
71772709|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.64|-1.6||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.60|-2.64|<0.001
71772710|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.46|-1.43||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.43|-2.46|<0.001
71772711|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.72|-0.64||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.64|-1.72|<0.001
71772712|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.18|-1.09||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.09|-2.18|<0.001
71733712|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.44|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|25.44
71772713|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.43|-1.35||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.35|-2.43|<0.001
71772714|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.93|-0.77||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.77|-1.93|<0.001
71772715|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.31|-1.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.15|-2.31|<0.001
71772716|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.47|-1.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.32|-2.47|<0.001
71772717|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.52|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-1.52|<0.001
71772718|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.91|-0.78||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.78|-1.91|<0.001
71772719|NCT00744471|143045050|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.09|-0.97||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.97|-2.09|<0.001
71772720|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
71772721|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.23|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.23|<0.001
71772722|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.83|-0.8||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.80|-1.83|<0.001
71772723|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.1|-1.08|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.08|-2.10|<0.001
71772724|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.61|-1.59||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.59|-2.61|<0.001
71772725|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.51|-1.49||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.49|-2.51|<0.001
71772726|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.83|-0.76||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.76|-1.83|<0.001
71772727|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.26|-1.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.19|-2.26|<0.001
71772728|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.53|-1.46||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.46|-2.53|<0.001
71772729|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.11|-1.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.00|-2.11|<0.001
71772730|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.49|-1.37||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.37|-2.49|<0.001
71733713|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||18.15|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|18.15
71733714|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||8.12|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|8.12
71889294|NCT01512264|143299971|OTHER|||||||0.203|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.203
71733715|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.39|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.39
71733716|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||10|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|10.00
71733717|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.88|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|29.88
71772731|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.83|-1.72||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.72|-2.83|<0.001
71772732|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.87|-0.75||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.75|-1.87|<0.001
71772733|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.58|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-2.14|-1.02||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.02|-2.14|<0.001
71772734|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
71772735|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.86|-0.74||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.74|-1.86|<0.001
71772736|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.17|-1.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.05|-2.17|<0.001
71772737|NCT00744471|143045051|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.91|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.47|-1.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-1.36|-2.47|<0.001
71772738|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
71772739|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
71772740|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
71889295|NCT01512264|143299971|OTHER|||||||0.01|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.||||0.010
71661224|NCT01739348|142836071|SUPERIORITY||Difference in Least Squares Means|0.7||||0.2949|TWO_SIDED|95.0|-0.6|2.1|||Longitudinal ANCOVA|||||2.1|-0.6|0.2949
71733718|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||12.63|TWO_SIDED|95.0|0.89|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.89|12.63
71733719|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.29|TWO_SIDED|95.0|0.91|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.91|32.29
71733720|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||69.92|TWO_SIDED|95.0|0.95|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.95|69.92
71733721|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||6.1|TWO_SIDED|95.0|0.84|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.84|6.10
71733722|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||33.63|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|33.63
71733723|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||86.07|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.07
71733724|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||41.38|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|41.38
71733725|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.88|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|24.88
71733726|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||29.89|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|29.89
71733727|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||7.13|TWO_SIDED|95.0|0.87|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.87|7.13
71772741|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
71661225|NCT01739348|142836071|SUPERIORITY||Difference in Least Squares Means|1.1||||0.1372|TWO_SIDED|95.0|-0.4|2.6|||Longitudinal ANCOVA|||||2.6|-0.4|0.1372
71661226|NCT01739348|142836072|SUPERIORITY||Difference in Least Squares Means|0.2||||0.4721|TWO_SIDED|95.0|-0.3|0.7|||Longitudinal ANCOVA|||||0.7|-0.3|0.4721
71733728|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||32.91|TWO_SIDED|95.0|0.9|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.90|32.91
71733729|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||81.15|TWO_SIDED|95.0|0.96|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.96|81.15
71733730|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||21.87|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|21.87
71733731|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||24.49|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|24.49
71733732|NCT02294734|142982911|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||55.52|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|55.52
71733733|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||59.55|TWO_SIDED|95.0|0.84|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.84|59.55
71733734|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.18||||94.01|TWO_SIDED|95.0|0.96|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.96|94.01
71733735|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||82.27|TWO_SIDED|95.0|0.9|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.90|82.27
71831864|NCT03779048|143168292|OTHER|Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.|r|0.17||||0.04|TWO_SIDED|||||Correlation to Implicit wanting of High Fat Savory.|Regression, Linear|||||||.04
71831865|NCT03779048|143168292|OTHER|Correlation to Implicit wanting of Low Fat Savory.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted.||||.72
71831866|NCT03779048|143168292|OTHER|Correlation to Implicit wanting of High Fat Sweet.|r|0.01||||0.94|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.94
71831867|NCT03779048|143168292|OTHER|Correlation to Implicit wanting of Low Fat Sweet.|r|-0.15||||0.09|TWO_SIDED||||||Regression, Linear|||Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.||||.09
71889296|NCT01512264|143299972|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
71889297|NCT01512264|143299972|OTHER|||||||0.618|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.||||0.618
71889298|NCT01512264|143299972|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.||||1.000
71661227|NCT01739348|142836072|SUPERIORITY||Difference in Least Squares Means|0.5||||0.0599|TWO_SIDED|95.0|0.0|1.0|||Longitudinal ANCOVA|||||1.0|0.0|0.0599
71733736|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||99.22|TWO_SIDED|95.0|1.06|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|1.06|99.22
71733737|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||46.24|TWO_SIDED|95.0|0.75|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.75|46.24
71733738|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||98.3|TWO_SIDED|95.0|1.02|1.64||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.64|1.02|98.30
71733739|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||92.6|TWO_SIDED|95.0|0.92|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.92|92.60
71733740|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||99.01|TWO_SIDED|95.0|1.05|1.81||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.81|1.05|99.01
71733741|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||58.8|TWO_SIDED|95.0|0.82|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.82|58.80
71733742|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||86.82|TWO_SIDED|95.0|0.91|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.91|86.82
71733743|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||67.37|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|67.37
71733744|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||98.35|TWO_SIDED|95.0|1.01|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|1.01|98.35
71733745|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||96.86|TWO_SIDED|95.0|0.99|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.99|96.86
71733746|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||86.18|TWO_SIDED|95.0|0.95|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.95|86.18
71831868|NCT03779048|143168293|OTHER|Correlation between baseline fasting active ghrelin and 4-week percent weight loss.|r|0.03||||0.73|TWO_SIDED||||||Regression, Linear|||||||.73
71831869|NCT03779048|143168294|OTHER||r|-0.1||||0.25|TWO_SIDED||||||Regression, Linear|||Correlation between baseline fasting leptin and 4-week percent weight loss.||||.25
71831870|NCT03779048|143168295|OTHER|Correlation between baseline postprandial AUC for change in insulin and 4-week percent weight loss.|r|-0.03||||0.72|TWO_SIDED||||||Regression, Linear|||||||.72
71831871|NCT03779048|143168296|OTHER|Correlation between baseline postprandial incremental AUC for PYY and 4-week percent weight loss.|r|-0.02||||0.82|TWO_SIDED||||||Regression, Linear|||||||.82
71733747|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||98.89|TWO_SIDED|95.0|1.02|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|1.02|98.89
71772742|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.88|<0.001
71772743|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.36||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.36|-0.73|<0.001
71772744|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.054|TWO_SIDED|95.0|-0.39|0.0||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||0.00|-0.39|0.054
71772745|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.29||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.29|-0.68|<0.001
71733748|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||91.94|TWO_SIDED|95.0|0.97|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.97|91.94
71733749|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||55.32|TWO_SIDED|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.88|55.32
71733750|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||97.17|TWO_SIDED|95.0|1.0|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|1.00|97.17
71733751|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||96.57|TWO_SIDED|95.0|0.99|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.99|96.57
71733752|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||79.13|TWO_SIDED|95.0|0.9|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.90|79.13
71772746|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
71772747|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.15||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.15|-0.55|<0.001
71831872|NCT03779048|143168297|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.002|TWO_SIDED|95.0|1.1|5.0|||Mixed Models Analysis|||||5.0|1.1|.002
71772748|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.81|-0.4||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.40|-0.81|<0.001
71831873|NCT03779048|143168302|SUPERIORITY|Difference between placebo- and phentermine-treated participants in change in delay discounting area under the curve from randomization to week 24 was calculated using repeated measures ANCOVA, controlling for age.|F|0.17||||0.68|TWO_SIDED||||||ANCOVA|||||||.68
71831874|NCT03779048|143168303|OTHER|Regression using the three Eating Inventory subscales (Cognitive restraint, disinhibition, hunger) to predict 4-week weight loss|r2|0.01||||0.75|TWO_SIDED|||||For full model including all 3 predictors|Regression, Linear|||||||.75
71831875|NCT03779048|143168304|OTHER|Correlation between baseline past-week appetite and 4-week percent weight loss.|r|-0.09||||0.31|TWO_SIDED||||||Regression, Linear|||||||.31
71889299|NCT01512264|143299972|OTHER|||||||0.019|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.||||0.019
71831876|NCT03779048|143168306|OTHER|Regression using baseline scores for Behavioral Inhibition (BIS) and Behavioral Activation fro Reward to predict 4-week weight loss during the behavioral treatment run-in.|r2|0.05||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
71831877|NCT03779048|143168307|OTHER|Correlation between baseline BIS-15 total score and 4-week percent weight loss.|r|0.03||||0.76|TWO_SIDED||||||Regression, Linear|||||||.76
71831878|NCT04588259|143168330|NON_INFERIORITY|The upper limit of the 95% confidence interval (CI) for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment difference|-0.05||||0.5102|TWO_SIDED|95.0|-0.19|0.09||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.||0.09|-0.19|0.5102
71831879|NCT04588259|143168331|NON_INFERIORITY|The upper limit of the 95% CI for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4%, non-inferiority was considered to be established and effect demonstrated.|Treatment Difference|-0.52||||0.5102|TWO_SIDED|95.0|-2.08|1.03||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|Mixed Models Analysis|||The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.||1.03|-2.08|0.5102
71831880|NCT01164098|143168359|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Using Natural Log Transformed Data||T-test of the natural logarithmic transformed data||||0.18
71661228|NCT01447420|142836085|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Chi-squared|Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.||IL28B Genotypes (CC, CT or TT)||||0.0007
71772749|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.73|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.73|<0.001
71772750|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|-0.45|-0.07||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.07|-0.45|0.008
71772751|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
71772752|NCT00744471|143045052|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|95.0|-0.43|-0.05||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.05|-0.43|0.012
71733753|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||99.54|TWO_SIDED|95.0|1.05|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|1.05|99.54
71733754|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||97.8|TWO_SIDED|95.0|1.0|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|1.00|97.80
71733755|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||71.94|TWO_SIDED|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.91|71.94
71733756|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||85.3|TWO_SIDED|95.0|0.94|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.23|0.94|85.30
71831881|NCT01164098|143168360|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||T-test of Natural Log Transformed Data.||||0.49
71831882|NCT01164098|143168361|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test||||0.37
71889300|NCT01512264|143299974|OTHER|||||||0.118|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.||||0.118
71889301|NCT01512264|143299974|OTHER|||||||0.482|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.482
71733757|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||82.15|TWO_SIDED|95.0|0.94|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.94|82.15
71733758|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||72.55|TWO_SIDED|95.0|0.88|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.88|72.55
71831883|NCT00232180|143168362|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.535|0.741||Using an adaptation of Haybittle-Peto stopping criterion adjusting for two interim analyses, p-value for final primary analysis will be compared to alpha=0.049. No adjustment in alpha will be made on parameters/endpoints other than primary endpoint.|Cox proportional hazard model|||Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, time from electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) and atrial fibrillation as covariates.||0.741|0.535|<0.0001
71831884|NCT00232180|143168364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.552|0.757||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.757|0.552|<0.0001
71889302|NCT01512264|143299974|OTHER|||||||0.368|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.||||0.368
71889303|NCT01512264|143299974|OTHER|||||||0.147|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.||||0.147
71733759|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||98.44|TWO_SIDED|95.0|1.02|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.47|1.02|98.44
71733760|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||78.24|TWO_SIDED|95.0|0.86|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.86|78.24
71733761|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||96.8|TWO_SIDED|95.0|0.99|1.52||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.52|0.99|96.80
71772753|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.18||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
71772754|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.83|-0.45||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.45|-0.83|<0.001
71772755|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.6|-0.22||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.22|-0.60|<0.001
71772756|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.65|<0.001
71772757|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.87|-0.5||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.50|-0.87|<0.001
71772758|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
71772759|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.43|-0.03||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.03|-0.43|0.022
71772760|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.67|-0.27||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.27|-0.67|<0.001
71659621|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|-5.98||||0.266|TWO_SIDED|95.0|-16.51|4.55|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||4.55|-16.51|0.266
71733762|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||91.11|TWO_SIDED|95.0|0.97|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.97|91.11
71733763|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||89.3|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|89.30
71733764|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||74.67|TWO_SIDED|95.0|0.87|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.87|74.67
71733765|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.23||||98.25|TWO_SIDED|95.0|1.02|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|1.02|98.25
71733766|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||87.8|TWO_SIDED|95.0|0.96|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.96|87.80
71733767|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||91.54|TWO_SIDED|95.0|0.97|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.97|91.54
71733768|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||68.89|TWO_SIDED|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.92|68.89
71733769|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.19|TWO_SIDED|95.0|1.01|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|1.01|98.19
71772761|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.26||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.26|-0.65|<0.001
71772762|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.19||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.19|-0.60|<0.001
71772763|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.88|-0.47||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.47|-0.88|<0.001
71659622|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|59.77|||<|0.001|TWO_SIDED|95.0|49.63|69.9|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.90|49.63|<0.001
71889304|NCT01512264|143299975|OTHER|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.||||0.410
71889305|NCT01512264|143299975|OTHER|||||||0.695|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.||||0.695
71889306|NCT01512264|143299975|OTHER|||||||0.175|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.||||0.175
71733770|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||94.07|TWO_SIDED|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.98|94.07
71733771|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.74|TWO_SIDED|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.92|75.74
71733772|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||95.83|TWO_SIDED|95.0|0.99|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.99|95.83
71733773|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||79.8|TWO_SIDED|95.0|0.94|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.94|79.80
71733774|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||95.29|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|95.29
71733775|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.27|TWO_SIDED|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.99|96.27
71733776|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.62|TWO_SIDED|95.0|0.94|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.94|47.62
71733777|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||71.55|TWO_SIDED|95.0|0.92|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.92|71.55
71889307|NCT01512264|143299975|OTHER|||||||0.518|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.||||0.518
71889308|NCT01512264|143299977|OTHER|||||||0.109|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.||||0.109
71889309|NCT01512264|143299977|OTHER|||||||0.485|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.||||0.485
71889310|NCT01512264|143299977|OTHER|||||||0.864|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.||||0.864
71889311|NCT01512264|143299977|OTHER|||||||0.341|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.||||0.341
71733778|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||98.29|TWO_SIDED|95.0|1.01|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|1.01|98.29
71733779|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Bayesian repeated measures model|1.08||||95.09|TWO_SIDED|95.0|0.99|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.99|95.09
71761231|NCT00611026|143024045|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0008
71761232|NCT00611026|143024045|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0022
71761233|NCT00611026|143024045|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71761234|NCT00611026|143024045|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0008
71761235|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0576
71761236|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.2230
71761237|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.3555|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.3555
71761238|NCT00611026|143024046|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
71761239|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0009
71761240|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.0071|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0071
71761241|NCT00611026|143024046|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||<0.0001
71831885|NCT00232180|143168365|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.761||||0.0081|TWO_SIDED|95.0|0.622|0.932||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.932|0.622|0.0081
71831886|NCT00232180|143168366|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.757||||0.012|TWO_SIDED|95.0|0.609|0.941||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.941|0.609|0.0120
71831887|NCT00232180|143168367|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||<|0.0001|TWO_SIDED|95.0|0.673|0.876||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.876|0.673|<0.0001
71831888|NCT00232180|143168368|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.576|||<|0.0001|TWO_SIDED|95.0|0.473|0.702||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.702|0.473|<0.0001
71831889|NCT00232180|143168369|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.751|||<|0.0001|TWO_SIDED|95.0|0.664|0.849||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.849|0.664|<0.0001
71831890|NCT00232180|143168370|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|||<|0.0001|TWO_SIDED|95.0|0.475|0.701||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.701|0.475|<0.0001
71831891|NCT00232180|143168371|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.694|||<|0.0001|TWO_SIDED|95.0|0.598|0.806||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.806|0.598|<0.0001
71831892|NCT00232180|143168372|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.316||||0.2321|TWO_SIDED|95.0|0.839|2.064||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.064|0.839|0.2321
71889312|NCT01512264|143299978|OTHER|||||||0.899|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.||||0.899
71889313|NCT01512264|143299978|OTHER|||||||0.519|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.||||0.519
71889314|NCT01512264|143299978|OTHER|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.||||1.000
71889315|NCT01512264|143299978|OTHER|||||||0.14|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.||||0.140
71889316|NCT01512264|143299980|OTHER|||||||0.52|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.||||0.520
71889317|NCT01512264|143299980|OTHER|||||||0.8|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.||||0.800
71889318|NCT01512264|143299980|OTHER|||||||0.148|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.||||0.148
71733780|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||93.68|TWO_SIDED|95.0|0.98|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.98|93.68
71733781|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||96.58|TWO_SIDED|95.0|1.0|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|1.00|96.58
71733782|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||56.99|TWO_SIDED|95.0|0.95|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.95|56.99
71733783|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||13.08|TWO_SIDED|95.0|0.85|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.85|13.08
71733784|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||52.99|TWO_SIDED|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.89|52.99
71733785|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||60.75|TWO_SIDED|95.0|0.9|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.90|60.75
71733786|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||75.23|TWO_SIDED|95.0|0.92|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.92|75.23
71772764|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.79|-0.39||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.39|-0.79|<0.001
71772765|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.14||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.14|-0.53|<0.001
71772766|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.68|-0.28||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.28|-0.68|<0.001
71772767|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.32|-0.71|<0.001
71831893|NCT00232180|143168373|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.789||||0.4213|TWO_SIDED|95.0|0.443|1.406||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.406|0.443|0.4213
71889319|NCT01512264|143299980|OTHER|||||||0.787|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.||||0.787
71733787|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||28.14|TWO_SIDED|95.0|0.78|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.78|28.14
71889320|NCT01512264|143299981|OTHER|||||||0.239|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.||||0.239
71889321|NCT01512264|143299981|OTHER|||||||0.212|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.||||0.212
71889322|NCT01512264|143299981|OTHER|||||||0.12|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.||||0.120
71889323|NCT01512264|143299981|OTHER|||||||0.263|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.||||0.263
71889324|NCT00854828|143299991|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71889325|NCT02411747|143299998|NON_INFERIORITY_OR_EQUIVALENCE|Beta: 0.8, p significant if p \> 0.005||||||0.34|||||||t-test, 2 sided|||Independent samples t-test||||0.34
71889326|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.77||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 16||0.77|0.63|< 0.001
71889327|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.8||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 18||0.80|0.64|< 0.001
71772768|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.01|TWO_SIDED|95.0|-0.47|-0.06||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.06|-0.47|0.010
71772769|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.66|-0.25||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.25|-0.66|<0.001
71772770|NCT00744471|143045053|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.53|-0.13||P-value is based on ANCOVA from pairwise comparisons.|ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect.||-0.13|-0.53|0.001
71772771|NCT01876810|143045097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1|TWO_SIDED|95.0||||For all analyses, results are considered significant at p\<.05.|t-test, 2 sided|||||||0.1
71772772|NCT01876810|143045097|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.1
71772773|NCT01876810|143045098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.034||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
71772774|NCT01876810|143045098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.05||0.9|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|t-test, 2 sided|||||||0.9
71772775|NCT01876810|143045099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.3|STANDARD_ERROR_OF_MEAN|31.7||0.4|TWO_SIDED|95.0|||||ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|participants self-reportd VAS craving at the time of neutral cue presentation|||||0.4
71772776|NCT01876810|143045099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.7|STANDARD_ERROR_OF_MEAN|26.5||0.4|TWO_SIDED|95.0||||For all analyses, results were considered significant at p\< 0.05|ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used||||||0.4
71772777|NCT00749580|143045136|SUPERIORITY_OR_OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
71772778|NCT00905827|143045138|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||<0.01
71772779|NCT00905827|143045138|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores||||0.01
71772780|NCT00509392|143045140|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71772781|NCT00509392|143045141|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71772782|NCT00509392|143045142|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71772783|NCT00509392|143045143|SUPERIORITY_OR_OTHER|||||||0.2962||95.0|||||t-test, 2 sided|||||||0.2962
71772784|NCT00509392|143045144|SUPERIORITY_OR_OTHER|||||||0.0048||95.0|||||t-test, 2 sided|||||||0.0048
71772785|NCT00509392|143045145|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||t-test, 2 sided|||||||0.0036
71772786|NCT00509392|143045146|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||t-test, 2 sided|||||||0.0005
71772787|NCT00509392|143045147|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||t-test, 2 sided|||||||0.5761
71772788|NCT00509392|143045148|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71772789|NCT00509392|143045149|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71772790|NCT00509392|143045150|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71772791|NCT00509392|143045151|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Fisher Exact|||||||0.0050
71772792|NCT00509392|143045153|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||t-test, 2 sided|||||||0.0009
71772793|NCT00509392|143045154|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||t-test, 2 sided|||||||0.0002
71772794|NCT00509392|143045155|SUPERIORITY_OR_OTHER|||||||0.0035||95.0|||||t-test, 2 sided|||||||0.0035
71772795|NCT00509392|143045156|SUPERIORITY_OR_OTHER|||||||0.2825||95.0|||||t-test, 2 sided|||||||0.2825
71772796|NCT00509392|143045157|SUPERIORITY_OR_OTHER|||||||0.0854||95.0|||||t-test, 2 sided|||||||0.0854
71889328|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.66|||<|0.001|TWO_SIDED|95.0|0.6|0.74||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 31||0.74|0.60|< 0.001
71733788|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||38.43|TWO_SIDED|95.0|0.84|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.84|38.43
71733789|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||25.21|TWO_SIDED|95.0|0.8|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.12|0.80|25.21
71772797|NCT00509392|143045158|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||t-test, 2 sided|||||||0.0044
71772798|NCT00509392|143045159|SUPERIORITY_OR_OTHER|||||||0.0457||95.0|||||t-test, 2 sided|||||||0.0457
71889329|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 33||0.80|0.67|< 0.001
71772799|NCT00509392|143045160|SUPERIORITY_OR_OTHER|||||||0.9463||95.0|||||t-test, 2 sided|||||||0.9463
71772800|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-1.99|-0.5||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.50|-1.99|
71772801|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.88|-0.52||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.52|-1.88|
71772802|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.76|0.69||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.69|-0.76|
71772803|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|-0.37|1.01||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 2 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.01|-0.37|
71772804|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.59|0.91||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.91|-0.59|
71772805|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 2 vs Timolol|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.77|0.71||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 2 and timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.71|-0.77|
71889330|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.68|||<|0.001|TWO_SIDED|95.0|0.6|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 45||0.76|0.60|< 0.001
71889331|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.78||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 52||0.78|0.64|< 0.001
71889332|NCT03158220|143299999|NON_INFERIORITY|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 58||0.76|0.63|< 0.001
71733790|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||81.73|TWO_SIDED|95.0|0.91|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.27|0.91|81.73
71733791|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.87|TWO_SIDED|95.0|0.76|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.76|9.87
71733792|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||63.15|TWO_SIDED|95.0|0.87|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.87|63.15
71733793|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||4.03|TWO_SIDED|95.0|0.86|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.86|4.03
71733794|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
71733795|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||80.34|TWO_SIDED|95.0|0.95|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.95|80.34
71733796|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||25.65|TWO_SIDED|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.89|25.65
71733797|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||24.36|TWO_SIDED|95.0|0.88|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.88|24.36
71733798|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.45|TWO_SIDED|95.0|0.91|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.91|48.45
71733799|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||1.95|TWO_SIDED|95.0|0.81|0.99||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.99|0.81|1.95
71733800|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||14.15|TWO_SIDED|95.0|0.85|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.85|14.15
71733801|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||80.61|TWO_SIDED|95.0|0.95|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.95|80.61
71733802|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||3.3|TWO_SIDED|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.81|3.30
71733803|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.22|TWO_SIDED|95.0|0.88|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.88|42.22
71733804|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.09||||95.24|TWO_SIDED|95.0|0.99|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.99|95.24
71733805|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||6.38|TWO_SIDED|95.0|0.83|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.83|6.38
71733806|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||28.82|TWO_SIDED|95.0|0.86|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.86|28.82
71733807|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.05||||87.39|TWO_SIDED|95.0|0.97|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.14|0.97|87.39
71733808|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||23.27|TWO_SIDED|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.87|23.27
71733809|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||57.82|TWO_SIDED|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.90|57.82
71772806|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs. Timolol|Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.84|-0.36||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.36|-1.84|
71889333|NCT03158220|143300002|OTHER||Difference in Percentages|-2.5||||0.212|TWO_SIDED|95.0|-6.4|1.4|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||1.4|-6.4|0.212
71889334|NCT03158220|143300003|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.3|3.4|||||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||3.4|-7.3|
71889335|NCT03158220|143300004|OTHER||Difference in Percentages|-1.0||||0.3|TWO_SIDED|95.0|-3.1|0.9|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.|||0.9|-3.1|0.300
71733810|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||9.67|TWO_SIDED|95.0|0.77|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.77|9.67
71733811|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||70.73|TWO_SIDED|95.0|0.89|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.89|70.73
71733812|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.61|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|25.61
71733813|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||44.1|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|44.10
71733814|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||10.14|TWO_SIDED|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.82|10.14
71733815|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||62.87|TWO_SIDED|95.0|0.9|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.90|62.87
71733816|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||11.82|TWO_SIDED|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.93|11.82
71733817|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||51.44|TWO_SIDED|95.0|0.95|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.95|51.44
71733818|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||9.54|TWO_SIDED|95.0|0.88|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.88|9.54
71733819|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||30.03|TWO_SIDED|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.89|30.03
71772807|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.81|-0.45||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Day 10, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||-0.45|-1.81|
71889336|NCT00996203|143300009|SUPERIORITY_OR_OTHER||||||<|0.001||||||EQ-5D scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
71889337|NCT00996203|143300012|SUPERIORITY_OR_OTHER||||||<|0.001||||||General health at baseline Versus Week 24|t-test, 2 sided|||||||<0.001
71889338|NCT00996203|143300014|SUPERIORITY_OR_OTHER||||||<|0.001||||||Baseline Versus Week 24 DAS28 scores|t-test, 2 sided|||||||<0.001
71889339|NCT00996203|143300016|SUPERIORITY_OR_OTHER||||||<|0.001||||||Mean HAQ scores at Baseline Versus Week 24|t-test, 2 sided|||||||<0.001
71889340|NCT00848120|143300099|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
71659623|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.62||||0.094|TWO_SIDED|95.0|-1.46|18.69|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.69|-1.46|0.094
71733820|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||73.03|TWO_SIDED|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.95|73.03
71772808|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.33|||||TWO_SIDED|95.0|-0.39|1.06||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 8AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.06|-0.39|
71733821|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||4.64|TWO_SIDED|95.0|0.83|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.83|4.64
71733822|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||42.13|TWO_SIDED|95.0|0.89|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.89|42.13
71733823|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||93.33|TWO_SIDED|95.0|0.98|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.98|93.33
71733824|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||27.33|TWO_SIDED|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.95|27.33
71733825|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||34.15|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|34.15
71889341|NCT00848120|143300100|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Week 24 versus baseline||||<0.001
71889342|NCT00848120|143300101|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||Week 24 versus baseline||||0.001
71733826|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||58.42|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|58.42
71733827|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||5.93|TWO_SIDED|95.0|0.86|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.86|5.93
71889343|NCT01988090|143300126|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
71889344|NCT01988090|143300128|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71889345|NCT01439945|143300138|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.13
71889346|NCT01439945|143300138|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.||||||0.67
71889347|NCT01439945|143300139|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|Weekly number of hot flashes were treated as a repeated measure for each patient.||||||0.25
71659624|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|10.43||||0.047|TWO_SIDED|95.0|0.15|20.72|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||20.72|0.15|0.047
71733828|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||35.88|TWO_SIDED|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.89|35.88
71733829|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||86.41|TWO_SIDED|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.97|86.41
71733830|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||13.52|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|13.52
71733831|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||32.84|TWO_SIDED|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.95|32.84
71733832|NCT02294734|142982912|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||78.09|TWO_SIDED|95.0|0.98|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.98|78.09
71733833|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||60.07|TWO_SIDED|95.0|0.66|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.66|60.07
71733834|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||51.75|TWO_SIDED|95.0|0.65|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.65|51.75
71733835|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||65.66|TWO_SIDED|95.0|0.6|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|0.60|65.66
71733836|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||81.67|TWO_SIDED|95.0|0.59|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.59|81.67
71733837|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||89.98|TWO_SIDED|95.0|0.51|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.51|89.98
71772809|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-0.46|0.93||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Week 6, 10AM Difference between Implant Group 1 vs. Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||0.93|-0.46|
71889348|NCT01439945|143300139|SUPERIORITY_OR_OTHER|||||||0.55||||||Weekly number of hot flashes were treated as a repeated measure for each patient.|ANOVA|||||||0.55
71889349|NCT01439945|143300142|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71889350|NCT01439945|143300143|SUPERIORITY_OR_OTHER|||||||0.47|||||||Kruskal-Wallis|||||||0.47
71889351|NCT01439945|143300143|SUPERIORITY_OR_OTHER|||||||0.09|||||||Kruskal-Wallis|||||||0.09
71889352|NCT04343651|143300162|SUPERIORITY|||||||0.818|||||||ANCOVA|||||||0.818
71889353|NCT04343651|143300163|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.4138|TWO_SIDED|95.0|0.43|1.41|||Likelihood test-Cox Prop. hazards model|Stratification factors: Baseline NEWS Total score and Age.||||1.41|0.43|0.4138
71831894|NCT00232180|143168374|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.994||||0.9754|TWO_SIDED|95.0|0.694|1.424||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.424|0.694|0.9754
71831895|NCT00232180|143168375|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.2652|TWO_SIDED|95.0|0.485|1.22||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.220|0.485|0.2652
71889354|NCT02587338|143300207|SUPERIORITY|||||||0.74|||||||ANOVA|||||||0.74
71889355|NCT02587338|143300208|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
71889356|NCT01506882|143300209|SUPERIORITY_OR_OTHER||Percent|73.8|||||TWO_SIDED|95.0|60.9|84.2||||||"The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.~The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p\>0.4, if the lower confidence limit for p was greater than 0.4."||84.2|60.9|
71733838|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||43.88|TWO_SIDED|95.0|0.7|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.70|43.88
71733839|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.1||||36.1|TWO_SIDED|95.0|0.64|1.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.91|0.64|36.10
71889357|NCT01302808|143300217|OTHER||Maximum Tolerated Dose|8.0|||||TWO_SIDED|||||||||||||
71889358|NCT00821678|143300219|SUPERIORITY_OR_OTHER||Slope|-3.81||||0.002|TWO_SIDED|95.0|-6.19|-1.43|||Mixed Models Analysis|||||-1.43|-6.19|0.002
71733840|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.74|TWO_SIDED|95.0|0.47|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.47|95.74
71733841|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.74|TWO_SIDED|95.0|0.67|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.67|50.74
71733842|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||72.81|TWO_SIDED|95.0|0.51|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.51|72.81
71733843|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.73||||94.41|TWO_SIDED|95.0|0.5|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.50|94.41
71831896|NCT00232180|143168376|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.971||||0.9537|TWO_SIDED|95.0|0.366|2.578||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||2.578|0.366|0.9537
71889359|NCT00821678|143300220|SUPERIORITY_OR_OTHER||Slope|-0.25||||0.001|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.1|-0.4|0.001
71889360|NCT00821678|143300221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.7|||t-test, 2 sided|||||0.70|-0.33|0.48
71889361|NCT00821678|143300222|SUPERIORITY_OR_OTHER||Slope|2.67||||0.02|TWO_SIDED|95.0|0.45|4.91|||Mixed Models Analysis|||||4.91|0.45|0.02
71889362|NCT00821678|143300225|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.86||||0.65|TWO_SIDED|95.0|0.46|1.62|||Mixed Models Analysis|||||1.62|0.46|0.65
71733844|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||81.07|TWO_SIDED|95.0|0.55|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.55|81.07
71733845|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||69.29|TWO_SIDED|95.0|0.5|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.50|69.29
71733846|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||73.67|TWO_SIDED|95.0|0.54|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.54|73.67
71733847|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.87||||75.82|TWO_SIDED|95.0|0.59|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.59|75.82
71733848|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||54.22|TWO_SIDED|95.0|0.69|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.69|54.22
71761242|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.1764|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.1764
71761243|NCT00611026|143024046|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).||||0.0001
71889363|NCT00821678|143300226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.9|||<|0.001|TWO_SIDED|95.0|3.2|19.6|||Mixed Models Analysis|||||19.6|3.2|<0.001
71889364|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|0.993||||0.791|TWO_SIDED|95.0|0.946|1.043|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.|||1.043|0.946|0.791
71761244|NCT00611026|143024047|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71761245|NCT00611026|143024047|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0003
71761246|NCT00611026|143024047|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0302
71761247|NCT00611026|143024047|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71761248|NCT00611026|143024047|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0007
71761249|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0701|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||0.0|-0.1|0.0701
71733849|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||66.46|TWO_SIDED|95.0|0.63|1.35||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.35|0.63|66.46
71733850|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.16||||21.45|TWO_SIDED|95.0|0.79|1.71||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.71|0.79|21.45
71733851|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||69.91|TWO_SIDED|95.0|0.5|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.50|69.91
71733852|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||75.29|TWO_SIDED|95.0|0.57|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.57|75.29
71733853|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.05|TWO_SIDED|95.0|0.68|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.58|0.68|44.05
71733854|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||94.93|TWO_SIDED|95.0|0.65|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.65|94.93
71733855|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.77||||97.11|TWO_SIDED|95.0|0.59|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.59|97.11
71772810|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|-0.23|1.28||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 8AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.28|-0.23|
71772811|NCT03868124|143045165|NON_INFERIORITY|criteria for statistical and clinical non-inferiority: upper limit of the 95% CI of the difference between the implant group and the timolol group was \< 1.5 mmHg and also \< 1 mmHg for all 6 timepoints for Implant Group 1 vs Timolol|Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.19|1.29||Fixed sequence hierarchical testing procedure was used, first testing for non-inferiority of Implant Group 2 to timolol at all 6 timepoints before testing non-inferiority of Implant Group 1 to timolol||||"Month 3, 10AM Difference between Implant Group 1 and Timolol~Note: Multiple imputation techniques were used to account for missing data such that the sample size at each visit /timepoint was the same for purposes of statistical analyses"||1.29|-0.19|
71772812|NCT04902326|143045182|SUPERIORITY|||||||0.78|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.78
71772813|NCT04902326|143045183|SUPERIORITY|||||||0.64|||||||Regression, Linear|||Compare the mean decrease of HbA1c of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.64
71772814|NCT04902326|143045184|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
71772815|NCT04902326|143045185|SUPERIORITY|||||||0.87|||||||Regression, Linear|||Compare the mean decrease of weight of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||0.87
71772816|NCT04902326|143045186|SUPERIORITY||||||<|0.0001|||||||Regression, Linear|||Compare the mean months engaged (with DPP or metformin) of the Combo Arm, Financial Incentives arm, and the Tailored Messages arm each with the EUC arm.||||<0.0001
71733856|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||85.41|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.41
71733857|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||54.73|TWO_SIDED|95.0|0.62|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.53|0.62|54.73
71733858|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||72.31|TWO_SIDED|95.0|0.61|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.30|0.61|72.31
71733859|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||15.05|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|15.05
71733860|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||84.87|TWO_SIDED|95.0|0.68|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.68|84.87
71733861|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||92.24|TWO_SIDED|95.0|0.63|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.63|92.24
71733862|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||63.42|TWO_SIDED|95.0|0.75|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.75|63.42
71733863|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.17||||9.05|TWO_SIDED|95.0|0.93|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.93|9.05
71733864|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||66.4|TWO_SIDED|95.0|0.74|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.74|66.40
71772817|NCT01117051|143045187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Cochran-Mantel-Haenszel|||||||0.305
71772818|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.6|-2.5|
71772819|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-9.6|||||TWO_SIDED|95.0|-16.0|-3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-3.3|-16.0|
71889365|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.|||1.050|0.952|>0.999
71889366|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.001||||0.975|TWO_SIDED|95.0|0.953|1.051|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.|||1.051|0.953|0.975
71889367|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.|||1.050|0.952|>0.999
71889368|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.003||||0.908|TWO_SIDED|95.0|0.955|1.053|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.|||1.053|0.955|0.908
71889369|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.025||||0.312|TWO_SIDED|95.0|0.977|1.077|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.|||1.077|0.977|0.312
71889370|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.763|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.|||1.058|0.960|0.763
71889371|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.095|||<|0.001|TWO_SIDED|95.0|1.043|1.15|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.|||1.150|1.043|<0.001
71889372|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.046||||0.07|TWO_SIDED|95.0|0.996|1.098|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.|||1.098|0.996|0.070
71889373|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|0.971||||0.238|TWO_SIDED|95.0|0.925|1.02|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.|||1.020|0.925|0.238
71889374|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|0.975||||0.298|TWO_SIDED|95.0|0.928|1.023|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.|||1.023|0.928|0.298
71889375|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|0.994||||0.821|TWO_SIDED|95.0|0.947|1.044|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.|||1.044|0.947|0.821
71889376|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|0.991||||0.715|TWO_SIDED|95.0|0.944|1.04|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.|||1.040|0.944|0.715
71889377|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.008||||0.759|TWO_SIDED|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.|||1.058|0.960|0.759
71889378|NCT01475734|143300227|SUPERIORITY_OR_OTHER||Ratio|1.0|||>|0.999|TWO_SIDED|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.|||1.050|0.952|>0.999
71889379|NCT02265913|143300238|EQUIVALENCE|provides 85% of success|Equivalence ratio|98.0|||||TWO_SIDED|90.0|92.0|105.0|||Fieller's method|||||105|92|
71889380|NCT02591615|143300257|SUPERIORITY|||||||0.2176|||||||Fisher Exact|||||||0.2176
71889381|NCT02591615|143300258|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.84|TWO_SIDED|95.0|0.67|1.64|||Log Rank|||||1.64|0.67|0.84
71889382|NCT02107703|143300266|OTHER||Hazard Ratio (HR)|0.553|||<|1e-07|TWO_SIDED|95.0|0.449|0.681||This is two sided P value and it is statistically significant.|Log Rank|Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).||The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.||0.681|0.449|<0.0000001
71889383|NCT04574999|143300315|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71889384|NCT04574999|143300316|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71889385|NCT04574999|143300318|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71889386|NCT04574999|143300319|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71889387|NCT05148884|143300338|OTHER|||||||0.0016|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0016
71889388|NCT05148884|143300338|OTHER|||||||0.6886|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.6886
71889389|NCT05148884|143300339|OTHER|||||||0.0281|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.0281
71889390|NCT05148884|143300339|OTHER|||||||0.7953|||||||Mixed Models Analysis|||Linear mixed model (LMM) of change from baseline with treatment, visit and the interaction treatment\*visit as fixed categorical effects and subject within treatment as a random effect. The baseline value of the dependent variable has been included in the model as a continuous covariate. Kenward-Roger's improved approximation for degrees of freedom (2009) has been used.||||0.7953
71889391|NCT01993888|143300352|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71889392|NCT03706365|143300407|OTHER||Hazard Ratio (HR)|0.829||||0.2123|TWO_SIDED|95.0|0.619|1.111|||Log Rank|||||1.111|0.619|0.2123
71889393|NCT03706365|143300408|OTHER||Hazard Ratio (HR)|0.637||||0.0026|TWO_SIDED|95.0|0.474|0.856|||Log Rank|||||0.856|0.474|0.0026
71889394|NCT03706365|143300409|OTHER||Hazard Ratio (HR)|0.842||||0.2899|TWO_SIDED|95.0|0.611|1.16|||Log Rank|||||1.160|0.611|0.2899
71889395|NCT03706365|143300411|OTHER||Hazard Ratio (HR)|0.731||||0.3531|TWO_SIDED|95.0|0.377|1.419|||Log Rank|||||1.419|0.377|0.3531
71889396|NCT03706365|143300412|OTHER||Hazard Ratio (HR)|0.927||||0.6507|TWO_SIDED|95.0|0.669|1.285|||Log Rank|||||1.285|0.669|0.6507
71889397|NCT03706365|143300413|OTHER||Hazard Ratio (HR)|0.768||||0.1807|TWO_SIDED|95.0|0.522|1.131|||Log Rank|||||1.131|0.522|0.1807
71889398|NCT03706365|143300418|OTHER||Hazard Ratio (HR)|0.935||||0.697|TWO_SIDED|95.0|0.665|1.314|||Log Rank|||||1.314|0.665|0.6970
71889399|NCT02162862|143300419|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71889400|NCT02162862|143300419|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71889401|NCT02162862|143300419|OTHER|||||||0.102|||||||t-test, 2 sided|||||||.102
71889402|NCT02162862|143300420|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71889403|NCT02162862|143300420|OTHER|||||||0.646|||||||t-test, 2 sided|||||||.646
71889404|NCT02162862|143300420|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71889405|NCT02064764|143300421|OTHER|Log-Rank Test For Comparing Treatment and Control||||||0.28|||||||Log Rank|||||||0.28
71889406|NCT02064764|143300422|OTHER|||||||0.7348|||||||Log Rank|||||||0.7348
71733865|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.78||||97.39|TWO_SIDED|95.0|0.6|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.00|0.60|97.39
71733866|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||16.02|TWO_SIDED|95.0|0.89|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.42|0.89|16.02
71733867|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||75.69|TWO_SIDED|95.0|0.68|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.21|0.68|75.69
71733868|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||90.22|TWO_SIDED|95.0|0.69|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.69|90.22
71733869|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.21||||9.64|TWO_SIDED|95.0|0.91|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.62|0.91|9.64
71733870|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.15||||20.44|TWO_SIDED|95.0|0.82|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.82|20.44
71772820|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|2.2|||||TWO_SIDED|95.0|-0.4|5.2||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.2|-0.4|
71772821|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.5|||||TWO_SIDED|95.0|-0.9|4.1||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.1|-0.9|
71772822|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.4|||||TWO_SIDED|95.0|-4.2|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.2|
71772823|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.3|||||TWO_SIDED|95.0|-3.8|3.3||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-3.8|
71772824|NCT00366340|143045237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-6.0|4.5||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.5|-6.0|
71772825|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.84|0.63|
71772826|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.82|0.52|
71772827|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.74|
71772828|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.07||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.76|
71772829|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|2.25|||||TWO_SIDED|95.0|2.04|2.49||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||2.49|2.04|
71831897|NCT00232180|143168377|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.154||||0.8539|TWO_SIDED|95.0|0.251|5.312||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||5.312|0.251|0.8539
71733871|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.06|TWO_SIDED|95.0|0.73|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.73|55.06
71733872|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.36||||5.29|TWO_SIDED|95.0|0.94|1.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.97|0.94|5.29
71733873|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.11||||28.82|TWO_SIDED|95.0|0.77|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.77|28.82
71733874|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||93|TWO_SIDED|95.0|0.61|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.61|93.00
71733875|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||1.64|TWO_SIDED|95.0|1.03|1.95||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.95|1.03|1.64
71733876|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.71|TWO_SIDED|95.0|0.72|1.38||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.38|0.72|50.71
71733877|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.68||||99.52|TWO_SIDED|95.0|0.51|0.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.91|0.51|99.52
71733878|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.1|TWO_SIDED|95.0|0.99|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.99|3.10
71761250|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.4823|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.1|0.4823
71761251|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.1702|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.0|-0.1|0.1702
71761252|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.1|-0.3|<0.0001
71761253|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0059|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.0|-0.2|0.0059
71733879|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||75.39|TWO_SIDED|95.0|0.71|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.71|75.39
71772830|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.71||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.71|0.51|
71772831|NCT00366340|143045238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.06|0.73|
71831898|NCT00232180|143168378|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.585||||0.0175|TWO_SIDED|95.0|0.376|0.91||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||0.910|0.376|0.0175
71831899|NCT00232180|143168379|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.885||||0.6009|TWO_SIDED|95.0|0.559|1.4||Statistically significant if p-value \<0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.||1.400|0.559|0.6009
71831900|NCT04723394|143168395|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|50.38||||0.01|TWO_SIDED|95.0|14.38|71.25|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||71.25|14.38|0.010
71831901|NCT04723394|143168396|SUPERIORITY||Relative Risk Reduction (100*[1-RR])|49.24||||0.009|TWO_SIDED|95.0|14.72|69.79|||Cochran-Mantel-Haenszel|CMH was stratified by randomization factors||AZD7442 vs Placebo||69.79|14.72|0.009
71889407|NCT02348099|143300478|OTHER|"A student's paired t-test will be used to determine the difference if any in CV of Glucose between injection sites. In the third phase, area under the curve will be measured to determine differences between insulin absorption levels. Statistical analysis will be performed using SPSS version 15.0.0 and SAS version 8.2 A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|Odds Ratio (OR)|95.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||"A student's paired t-test will be used to determine the difference if any in CV of glucose between injection sited.~If the null hypothesis is true, it suggests that any changes witnessed in an experiment are because of random chance and not because of changes made to variables in the experiment. A power calculation is a statistical method used to determine the minimum sample size needed to detect a statistically significant effect of a certain size."|a P-Value is \<0.01|||<0.01
71889408|NCT01577238|143300535|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71772832|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.6|||||TWO_SIDED|95.0|-3.0|8.3||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||8.3|-3.0|
71772833|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.5|||||TWO_SIDED|95.0|-4.1|13.0||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||13.0|-4.1|
71772834|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.5||||||For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.4|
71831902|NCT00774397|143168398|SUPERIORITY_OR_OTHER|||||||0.0537||95.0||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0537
71831903|NCT00774397|143168398|SUPERIORITY_OR_OTHER|||||||0.0213||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||0.0213
71831904|NCT00774397|143168398|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
71831905|NCT00774397|143168398|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
71733880|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||93.29|TWO_SIDED|95.0|0.68|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.68|93.29
71831906|NCT00774397|143168398|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
71831907|NCT00774397|143168398|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value based on Fisher's exact test (2-sided)|Fisher Exact|||||||<0.0001
71831908|NCT00253890|143168439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.7||||0.05||95.0|||||t-test, 2 sided|||Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.||||.05
71733881|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.33||||3.79|TWO_SIDED|95.0|0.97|1.82||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.82|0.97|3.79
71733882|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||36.75|TWO_SIDED|95.0|0.76|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.48|0.76|36.75
71733883|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.72||||99.32|TWO_SIDED|95.0|0.56|0.93||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.93|0.56|99.32
71733884|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.06||||18.91|TWO_SIDED|95.0|0.93|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.93|18.91
71733885|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.35|TWO_SIDED|95.0|0.87|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.15|0.87|47.35
71733886|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.96||||78|TWO_SIDED|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.86|78.00
71733887|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.29||||2.65|TWO_SIDED|95.0|1.0|1.67||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.67|1.00|2.65
71733888|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||58.48|TWO_SIDED|95.0|0.73|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.29|0.73|58.48
71733889|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||99.64|TWO_SIDED|95.0|0.61|0.92||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.92|0.61|99.64
71733890|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||1.9|TWO_SIDED|95.0|1.01|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.40|1.01|1.90
71761254|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0014|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.0|-0.2|0.0014
71761255|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.1|-0.3|<0.0001
71889409|NCT01256177|143300540|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
71733891|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.97||||63.03|TWO_SIDED|95.0|0.81|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.16|0.81|63.03
71733892|NCT02294734|142982913|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.83||||99.19|TWO_SIDED|95.0|0.72|0.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.97|0.72|99.19
71733893|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||67.19|TWO_SIDED|95.0|0.64|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.33|0.64|67.19
71733894|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||44.8|TWO_SIDED|95.0|0.66|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.66|44.80
71733895|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||59.9|TWO_SIDED|95.0|0.61|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.46|0.61|59.90
71733896|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||70.12|TWO_SIDED|95.0|0.63|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.31|0.63|70.12
71733897|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.82||||83.98|TWO_SIDED|95.0|0.54|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.22|0.54|83.98
71761256|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.311|TWO_SIDED|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.1|0.3110
71761257|NCT00611026|143024048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.0004|TWO_SIDED|95.0|-0.2|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.1|-0.2|0.0004
71761258|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.0136|TWO_SIDED|95.0|-2.7|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.3|-2.7|0.0136
71761259|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1918|TWO_SIDED|95.0|-2.0|0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.4|-2.0|0.1918
71761260|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1505|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.3|-1.7|0.1505
71761261|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.2|-2.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-2.6|-5.2|<0.0001
71761262|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0034|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.7|-3.3|0.0034
71733898|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.08||||34.93|TWO_SIDED|95.0|0.73|1.57||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.57|0.73|34.93
71733899|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.14||||32.45|TWO_SIDED|95.0|0.65|1.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.96|0.65|32.45
71733900|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||95.35|TWO_SIDED|95.0|0.46|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.46|95.35
71733901|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||50.1|TWO_SIDED|95.0|0.66|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.54|0.66|50.10
71733902|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||59.37|TWO_SIDED|95.0|0.55|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.55|59.37
71733903|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.8||||87.99|TWO_SIDED|95.0|0.55|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.55|87.99
71733904|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||70.87|TWO_SIDED|95.0|0.59|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.59|70.87
71889410|NCT01256177|143300541|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54||||0.001|TWO_SIDED|95.0|1.56|4.13|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||4.13|1.56|0.001
71733905|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||63.71|TWO_SIDED|95.0|0.51|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.51|63.71
71733906|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||65.99|TWO_SIDED|95.0|0.57|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.57|65.99
71733907|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.89||||71.95|TWO_SIDED|95.0|0.6|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.60|71.95
71733908|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.28|TWO_SIDED|95.0|0.71|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.71|48.28
71772835|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-9.3|0.3||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||0.3|-9.3|
71733909|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.95||||61.06|TWO_SIDED|95.0|0.65|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.39|0.65|61.06
71733910|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||18.05|TWO_SIDED|95.0|0.82|1.74||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.74|0.82|18.05
71733911|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||61.12|TWO_SIDED|95.0|0.53|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.61|0.53|61.12
71733912|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.92||||64.4|TWO_SIDED|95.0|0.61|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|0.61|64.40
71733913|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||38.12|TWO_SIDED|95.0|0.69|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.66|0.69|38.12
71733914|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||91|TWO_SIDED|95.0|0.67|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.67|91.00
71733915|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.81||||94.52|TWO_SIDED|95.0|0.62|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.62|94.52
71733916|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.9||||82.11|TWO_SIDED|95.0|0.72|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.72|82.11
71761263|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0006|TWO_SIDED|95.0|-3.0|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.8|-3.0|0.0006
71761264|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.0|-2.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-2.3|-5.0|<0.0001
71761265|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.0859|TWO_SIDED|95.0|-2.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.2|-2.5|0.0859
71761266|NCT00611026|143024049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-1.4|-3.6|<0.0001
71761267|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 1.||||0.0008
71761268|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.||||0.0024
71733917|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||48.1|TWO_SIDED|95.0|0.64|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.60|0.64|48.10
71733918|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||65.66|TWO_SIDED|95.0|0.64|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.36|0.64|65.66
71733919|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.25||||11.46|TWO_SIDED|95.0|0.87|1.8||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.80|0.87|11.46
71733920|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.91||||77.2|TWO_SIDED|95.0|0.7|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.17|0.70|77.20
71733921|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||87.35|TWO_SIDED|95.0|0.66|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.66|87.35
71733922|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||56.53|TWO_SIDED|95.0|0.77|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.77|56.53
71733923|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.19||||7.29|TWO_SIDED|95.0|0.94|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.50|0.94|7.29
71733924|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||55.09|TWO_SIDED|95.0|0.75|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.28|0.75|55.09
71733925|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.79||||96.49|TWO_SIDED|95.0|0.61|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.61|96.49
71733926|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.13||||14.54|TWO_SIDED|95.0|0.9|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.44|0.90|14.54
71733927|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.94||||66.85|TWO_SIDED|95.0|0.71|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.25|0.71|66.85
71761269|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.6514|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.||||0.6514
71761270|NCT00611026|143024050|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 4.||||<0.0001
71761271|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.||||0.0063
71733928|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.88||||85.77|TWO_SIDED|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.11|0.70|85.77
71733929|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.24||||8.67|TWO_SIDED|95.0|0.91|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|0.91|8.67
71733930|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||14.8|TWO_SIDED|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.75|0.84|14.80
71733931|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||45.69|TWO_SIDED|95.0|0.75|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.37|0.75|45.69
71733932|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.42||||2.94|TWO_SIDED|95.0|0.99|2.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.06|0.99|2.94
71772836|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||1.5|-1.5|
71772837|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.0|2.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||2.3|-5.0|
71772838|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.7|||||TWO_SIDED|95.0|-0.4|4.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||4.4|-0.4|
71772839|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.4|-1.4|
71772840|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||1.4|-1.4|
71772841|NCT00366340|143045241|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8||||||95.0|-1.3|3.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated||3.3|-1.3|
71772842|NCT00366340|143045242|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.58|0.96|
71772843|NCT00366340|143045242|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39||||||For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated||1.39|0.95|
71831909|NCT00077675|143168440|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%||||||0.5318|||||||2-sided 95% confidence interval calculat|||95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Difference||||0.5318
71889411|NCT01256177|143300542|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.001|TWO_SIDED|95.0|1.46|3.86|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo|||3.86|1.46|0.001
71889412|NCT01256177|143300543|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-1.47|STANDARD_ERROR_OF_MEAN|0.67||0.029|TWO_SIDED|95.0|-2.79|-0.15|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)||-0.15|-2.79|0.029
71889413|NCT01256177|143300543|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.43|STANDARD_ERROR_OF_MEAN|0.88||0.006|TWO_SIDED|95.0|-4.16|-0.69|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)||-0.69|-4.16|0.006
71659625|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.95|||<|0.001|TWO_SIDED|95.0|40.5|61.4|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.40|40.50|<0.001
71772844|NCT00366340|143045243|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.68|||||TWO_SIDED|95.0|0.57|0.8||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
71659626|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.34|||<|0.001|TWO_SIDED|95.0|38.79|59.89|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||59.89|38.79|<0.001
71772845|NCT00366340|143045243|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87|||||TWO_SIDED|95.0|0.75|1.01||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.01|0.75|
71772846|NCT00366340|143045244|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.11||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.||1.11|0.69|
71772847|NCT00366340|143045244|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93|||||TWO_SIDED|95.0|0.71|1.22||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.71|
71772848|NCT03355664|143045249|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.38|TWO_SIDED|95.0|0.2|1.9|||Regression, Cox|||||1.9|0.2|0.38
71772849|NCT01315236|143045284|SUPERIORITY|||||||0.072||||||Conducted in the mITT population using a stratified Wilcoxon rank sum test, to compare the treatment arms at a 2-sided significance level of 0.05, adjusting for the randomization strata (presence/absence of CF and MAC versus Mycobacterium abscessus).|Wilcoxon rank sum test|||"The primary efficacy analysis tested the following hypotheses:~* H0: There is no difference at Day 84 between the LAI arm and the placebo arm~* Ha: There is a difference at Day 84 between the LAI arm and the placebo arm~Statistical analysis applies to all day 84 rows."||||0.072
71772850|NCT01315236|143045285|SUPERIORITY|||||||0.003|||||||Cochran-Mantel-Haenszel|||stratified Cochran-Mantel-Haenszel test||||0.003
71772851|NCT01315236|143045286|SUPERIORITY||Cox Proportional Hazard|5.68||||0.0129|TWO_SIDED|95.0|1.25|25.79|||Regression, Cox|||Cox proportional hazard model||25.79|1.25|0.0129
71772852|NCT01315236|143045287|SUPERIORITY|||||||0.077|||||||Regression, Logistic|||Ordinal Logistic Regressions Model||||0.077
71772853|NCT01315236|143045288|SUPERIORITY|||||||0.4545|||||||Wilcoxon (Mann-Whitney)|||Stratified Wilcoxon-rank sum||||0.4545
71772854|NCT01315236|143045290|SUPERIORITY||Cox Proportional Hazard|2.69||||0.0076|TWO_SIDED|95.0|1.28|5.64|||Regression, Cox|||Cox Proportional Hazard Model||5.64|1.28|0.0076
71772855|NCT01617148|143045295|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71772856|NCT01617148|143045296|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71772857|NCT01617148|143045297|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
71772858|NCT01617148|143045298|SUPERIORITY_OR_OTHER|||||||0.038|||||||t-test, 2 sided|||||||0.038
71772859|NCT04218123|143045319|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||<|0.001|||||||ANOVA|||||||<0.001
71772860|NCT04218123|143045319|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
71772861|NCT04218123|143045319|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||<|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||<0.05
71772862|NCT04218123|143045319|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent|||||>|0.05|||||||ANOVA|Anova Post Hoc Analysis||||||>0.05
71772863|NCT04218123|143045321|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.31|||||||ANOVA|||SF20 Physical Functioning||||=0.31
71772864|NCT04218123|143045321|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.633|||||||ANOVA|||SF20 Role Functioning||||0.633
71772865|NCT04218123|143045321|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.424|||||||ANOVA|||SF20 Mental Health||||0.424
71772866|NCT04218123|143045321|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.057|||||||ANOVA|||SF20 Social Functioning||||0.057
71772867|NCT04218123|143045321|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.296|||||||ANOVA|||SF20 Health Perceptions||||0.296
71772868|NCT04218123|143045321|EQUIVALENCE|p value of \<0.05 required for result to be considered nonequivalent||||||0.872|||||||ANOVA|||SF20 Pain||||0.872
71889414|NCT01256177|143300543|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.12|STANDARD_ERROR_OF_MEAN|0.95||0.001|TWO_SIDED|95.0|-5.0|-1.25|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)||-1.25|-5.00|0.001
71733933|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||13.92|TWO_SIDED|95.0|0.85|1.73||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.73|0.85|13.92
71733934|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.86||||86.4|TWO_SIDED|95.0|0.65|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.13|0.65|86.40
71772869|NCT04218123|143045322|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.538|||||||ANOVA|||||||=0.538
71733935|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.46||||0.88|TWO_SIDED|95.0|1.06|2.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||2.00|1.06|0.88
71733936|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||41.25|TWO_SIDED|95.0|0.75|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.43|0.75|41.25
71733937|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.7||||99.2|TWO_SIDED|95.0|0.52|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.52|99.20
71733938|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.22||||3.49|TWO_SIDED|95.0|0.98|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.51|0.98|3.49
71733939|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.93||||73.09|TWO_SIDED|95.0|0.72|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.19|0.72|73.09
71772870|NCT04218123|143045323|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.686|||||||ANOVA|||||||=0.686
71772871|NCT04218123|143045324|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.167|||||||ANOVA|||||||=0.167
71772872|NCT04218123|143045325|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.8|||||||ANOVA|||||||=0.8
71772873|NCT04218123|143045326|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent|||||=|0.425|||||||ANOVA|||||||=0.425
71772874|NCT04218123|143045327|EQUIVALENCE|p value \<0.05 required to be considered nonequivalent.|||||=|0.054|||||||ANOVA|||||||=0.054
71772875|NCT02797054|143045349|OTHER|||||||0.069|||||||Chi-squared|||||||0.069
71772876|NCT02797054|143045350|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
71772877|NCT02797054|143045351|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71772878|NCT02797054|143045352|OTHER|||||||0.895|||||||Chi-squared|||||||0.895
71772879|NCT02797054|143045353|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
71661229|NCT01447420|142836088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.69|4.14|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia after the first month of treatment vs No anemia||4.14|0.69|
71772880|NCT02797054|143045354|OTHER|||||||0.0015|||||||Chi-squared|||||||0.0015
71772881|NCT02797054|143045355|OTHER|||||||0.0056|||||||Chi-squared|||||||0.0056
71772882|NCT02797054|143045356|OTHER|||||||0.21|||||||Chi-squared|||||||0.21
71772883|NCT04644783|143045357|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
71772884|NCT04644783|143045358|SUPERIORITY||||||<|0.0001|||||||Regression, non-linear mixed effects|||||||<0.0001
71772885|NCT02378025|143045428|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||.25
71772886|NCT02378025|143045429|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||.08
71772887|NCT02378025|143045430|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
71772888|NCT02378025|143045431|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||||||.25
71772889|NCT02378025|143045432|SUPERIORITY|||||||0.22|||||||Regression, Logistic|||||||.22
71772890|NCT02378025|143045433|SUPERIORITY|||||||0.41|||||||Regression, Logistic|||||||.41
71772891|NCT01476644|143045447|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Regression, Linear|||||||<0.01
71772892|NCT04706416|143045462|SUPERIORITY||Odds Ratio (OR)|0.6||||0.297|TWO_SIDED|95.0|0.26|1.48|||Fisher Exact|||||1.48|0.26|0.297
71772893|NCT04706416|143045462|SUPERIORITY||Odds Ratio (OR)|0.68||||0.541|TWO_SIDED|95.0|0.19|2.3|||Regression, Logistic|||||2.30|0.19|0.541
71772894|NCT04706416|143045463|SUPERIORITY||Odds Ratio (OR)|0.37||||0.039|TWO_SIDED|95.0|0.15|0.91|||Fisher Exact|||||0.91|0.15|0.039
71733940|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||92.41|TWO_SIDED|95.0|0.69|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.69|92.41
71733941|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.38||||2.29|TWO_SIDED|95.0|1.01|1.89||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.89|1.01|2.29
71733942|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.12||||23.67|TWO_SIDED|95.0|0.81|1.56||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.56|0.81|23.67
71733943|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.75||||98.87|TWO_SIDED|95.0|0.59|0.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.96|0.59|98.87
71733944|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.07||||14.5|TWO_SIDED|95.0|0.95|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.20|0.95|14.50
71889415|NCT01256177|143300543|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.08|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|-4.12|-0.05|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)||-0.05|-4.12|0.045
71889416|NCT01256177|143300543|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-3.22|STANDARD_ERROR_OF_MEAN|1.1||0.004|TWO_SIDED|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)||-1.04|-5.39|0.004
71889417|NCT01256177|143300544|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.83||0.007|TWO_SIDED|95.0|-3.88|-0.61|||Mixed Model Repeated Measures (MMRM)|Baseline HAM-D total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)||-0.61|-3.88|0.007
71889418|NCT01256177|143300545|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.84|-0.17|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for overall BP illness as covariate, trt, bipolar strata, visit, trt-visit interaction as fixed effect and centre as random.||Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)||-0.17|-0.84|0.003
71889419|NCT01256177|143300545|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.47|STANDARD_ERROR_OF_MEAN|0.17||0.007|TWO_SIDED|95.0|-0.81|-0.13|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for depression as covariate, trt, Bipolar strata, visit, trt-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)||-0.13|-0.81|0.007
71733945|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||30.26|TWO_SIDED|95.0|0.91|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.91|30.26
71889420|NCT01256177|143300546|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.004|TWO_SIDED|95.0|1.26|3.36|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, baseline score and bipolar Strata.|Quetiapine XR/Placebo|||3.36|1.26|0.004
71889421|NCT01256177|143300547|SUPERIORITY_OR_OTHER||Least Square Mean difference vs Placebo|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS item 10 score as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effect and centre as random.||Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)||-0.07|-0.38|0.005
71889422|NCT01256177|143300548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.233|TWO_SIDED|95.0|0.03|2.38|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, strata and baseline score.|Quetiapine XR/Placebo|||2.38|0.03|0.233
71889423|NCT04398732|143300559|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 12.||||0.0001
71889424|NCT04398732|143300560|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 12.||||0.0001
71772895|NCT04706416|143045463|SUPERIORITY||Odds Ratio (OR)|0.34||||0.081|TWO_SIDED|95.0|0.09|1.07|||Regression, Logistic|||||1.07|0.09|0.081
71733946|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||62.84|TWO_SIDED|95.0|0.89|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.89|62.84
71733947|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.31||||2.06|TWO_SIDED|95.0|1.01|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.70|1.01|2.06
71733948|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.97|TWO_SIDED|95.0|0.76|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.32|0.76|49.97
71733949|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.76||||99.43|TWO_SIDED|95.0|0.62|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.94|0.62|99.43
71733950|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.2||||1.17|TWO_SIDED|95.0|1.02|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.41|1.02|1.17
71733951|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||49.78|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.18|0.84|49.78
71733952|NCT02294734|142982914|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.85||||98.66|TWO_SIDED|95.0|0.73|0.98||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||0.98|0.73|98.66
71733953|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|32.51
71733954|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.21|TWO_SIDED|95.0|0.99|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.08|0.99|6.21
71733955|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||15.91|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|15.91
71733956|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||6.73|TWO_SIDED|95.0|0.99|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.09|0.99|6.73
71733957|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||27.65|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|27.65
71761272|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0494|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.||||0.0494
71733958|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||12.19|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|12.19
71733959|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||11.62|TWO_SIDED|95.0|0.98|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.98|11.62
71733960|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||7.66|TWO_SIDED|95.0|0.99|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.10|0.99|7.66
71733961|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.88|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.88
71772896|NCT04706416|143045464|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.643|TWO_SIDED|95.0|-1.0|3.0|||Wilcoxon (Mann-Whitney)|||||3.0|-1.0|0.643
71772897|NCT04706416|143045464|SUPERIORITY||β-coefficient|-4.27||||0.001|TWO_SIDED|95.0|-5.67|-2.87|||Regression, Linear|||||-2.87|-5.67|0.001
71772898|NCT04706416|143045465|SUPERIORITY||Odds Ratio (OR)|0.53||||0.133|TWO_SIDED|95.0|0.25|1.19|||Fisher Exact|||||1.19|0.25|0.133
71772899|NCT04706416|143045466|SUPERIORITY||Hodges-Lehmann estimator|4.0||||0.092|TWO_SIDED|95.0|-1.0|12.0|||Wilcoxon (Mann-Whitney)|||||12.0|-1.0|0.092
71772900|NCT04706416|143045467|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.834|TWO_SIDED|95.0|-2.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|-2.0|0.834
71772901|NCT04706416|143045468|SUPERIORITY||Odds Ratio (OR)|0.001||||0.149|TWO_SIDED|95.0|0.0|1.52|||Fisher Exact|||||1.52|0|0.149
71772902|NCT04706416|143045469|SUPERIORITY||Odds Ratio (OR)|0.3||||0.015|TWO_SIDED|95.0|0.12|0.8|||Fisher Exact|||||0.80|0.12|0.015
71772903|NCT01539317|143045475|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Wilcoxon (Mann-Whitney)|||Phase II: During Blinded 4 weeks||||0.0149
71772904|NCT01539317|143045475|SUPERIORITY_OR_OTHER|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Phase III||||0.412
71889425|NCT04398732|143300561|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 12.||||0.0001
71772905|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Desire||||0.66
71772906|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Arousal (S)||||0.11
71772907|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Arousal (L)||||0.15
71772908|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Arousal (C)||||0.28
71889426|NCT04398732|143300562|OTHER|||||||0.036|||||||Student's t-test|||Baseline||||0.036
71889427|NCT04398732|143300562|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
71889428|NCT04398732|143300562|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
71733962|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.28|TWO_SIDED|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.96|28.28
71772909|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Orgasm||||0.07
71772910|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Pain||||0.004
71772911|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Enjoyment||||0.54
71772912|NCT01539317|143045476|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Partner||||0.92
71772913|NCT01539317|143045477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Each of 8 site comparisons had its own P-value and a value of \<0.001 was the difference at the most tender sites|Wilcoxon (Mann-Whitney)|||||||<0.001
71772914|NCT04616027|143045491|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|99.67|||||TWO_SIDED|90.0|70.15|141.6||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||141.60|70.15|
71772915|NCT04616027|143045491|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.34|||||TWO_SIDED|90.0|70.51|145.63||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||145.63|70.51|
71772916|NCT04616027|143045491|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|146.56|||||TWO_SIDED|90.0|103.16|208.22||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||208.22|103.16|
71772917|NCT04616027|143045491|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|71.31|143.92||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||143.92|71.31|
71889429|NCT04398732|143300563|OTHER|||||||0.42|||||||Student's t-test|||Baseline||||0.42
71889430|NCT04398732|143300563|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
71889431|NCT04398732|143300563|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
71889432|NCT04398732|143300564|OTHER|||||||0.72|||||||Student's t-test|||Baseline||||0.72
71889433|NCT04398732|143300564|OTHER|||||||0.0001|||||||Student's t-test|||Month 4||||0.0001
71889434|NCT04398732|143300564|OTHER|||||||0.0001|||||||Student's t-test|||Month 12||||0.0001
71733963|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||27.87|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|27.87
71772918|NCT04616027|143045492|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.71|||||TWO_SIDED|90.0|79.52|156.93||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||156.93|79.52|
71772919|NCT04616027|143045492|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.31|||||TWO_SIDED|90.0|83.49|173.38||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||173.38|83.49|
71831910|NCT02765100|143168442|EQUIVALENCE|Unless specified otherwise, each of the statistical tests above will use a two-tailed alpha-level of 0.05.|Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|3.4|<|0.05|TWO_SIDED||||||t-test, 2 sided|||This is a pilot proof of concept study and does not require formal sample size calculations. High and low CRP groups will be compared on demographic, clinical and biological variables using two-sample t-tests or analysis of variance (ANOVA) tests for continuous variables (for nonparametric continuous variables, either Mann-Whitney tests or Kruskal-Wallis tests will be used) and chi-square tests or Fisher's exact tests for categorical variables.||||<0.05
71889435|NCT04398732|143300565|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from Baseline in percent BSA at Month 4.||||0.0001
71733964|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||9.83|TWO_SIDED|95.0|0.99|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.99|9.83
71733965|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||21.87|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|21.87
71733966|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||18.58|TWO_SIDED|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.97|18.58
71733967|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.28|TWO_SIDED|95.0|0.98|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.98|22.28
71772920|NCT04616027|143045492|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.18|||||TWO_SIDED|90.0|94.46|190.62||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||190.62|94.46|
71889436|NCT04398732|143300566|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in DLQI at Month 4.||||0.0001
71889437|NCT04398732|143300567|OTHER|||||||0.0001|||||||Student's t-test|||Statistical analysis was performed on change from baseline in PASI at Month 4.||||0.0001
71889438|NCT01570244|143300578|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|140.96|STANDARD_DEVIATION|8.1|||TWO_SIDED|90.0|133.84|148.47|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||148.47|133.84|
71733968|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.03||||10.86|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|10.86
71733969|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.89|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.89
71772921|NCT04616027|143045492|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|100.99|||||TWO_SIDED|90.0|71.89|141.87||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.87|71.89|
71772922|NCT04616027|143045493|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|111.02|||||TWO_SIDED|90.0|79.6|154.86||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||154.86|79.60|
71772923|NCT04616027|143045493|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|116.7|||||TWO_SIDED|90.0|82.76|164.56||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||164.56|82.76|
71772924|NCT04616027|143045493|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|134.68|||||TWO_SIDED|90.0|96.56|187.85||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||187.85|96.56|
71772925|NCT04616027|143045493|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.31|||||TWO_SIDED|90.0|72.63|141.3||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||141.30|72.63|
71772926|NCT04616027|143045494|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|101.52|||||TWO_SIDED|90.0|88.89|115.94||||||"T2DM Normal Renal Function was test, Healthy and Normal Renal Function was reference."||115.94|88.89|
71772927|NCT04616027|143045494|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|110.17|||||TWO_SIDED|90.0|96.05|126.37||||||"T2DM Mild Renal Impairment was test, T2DM Normal Renal Function was reference."||126.37|96.05|
71772928|NCT04616027|143045494|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|120.63|||||TWO_SIDED|90.0|105.63|137.77||||||"T2DM Moderate Renal Impairment was test, T2DM Normal Renal Function was reference."||137.77|105.63|
71772929|NCT04616027|143045494|OTHER|ANOVA|Ratio (Test/Reference) of Adjusted Means|127.06|||||TWO_SIDED|90.0|111.26|145.12||||||"T2DM Severe Renal Impairment was test, T2DM Normal Renal Function was reference."||145.12|111.26|
71772930|NCT03737851|143045509|OTHER|a statistical test was not performed|Odds Ratio (OR)|1.202|||||TWO_SIDED|95.0|0.559|2.584||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||2.584|0.559|
71831911|NCT02652442|143168466|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the off-axis distance of 3.5 cm and 7.0 cm.||||0.97
71831912|NCT02652442|143168466|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation duration of 1 minute and 3 minutes.||||0.51
71831913|NCT02652442|143168466|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Paired samples t-test for change in SVV (measured in degrees)||Null hypothesis: The change in SVV (Post-OAR - Pre-OAR) will not be different for the centrifugation schedule of daily OAR and biweekly OAR for a total of 5 sessions.||||0.44
71831914|NCT03292913|143168508|SUPERIORITY||Risk Ratio (RR)|1.07||||0.22|TWO_SIDED|95.0|0.96|1.21|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.||Outcome measure for this analysis is viral load suppression. A priori threshold for statistical significance is p-value less than 0.05.||1.21|0.96|0.220
71831915|NCT03292913|143168509|SUPERIORITY||Risk Ratio (RR)|1.04||||0.481|TWO_SIDED|95.0|0.94|1.15|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is retention in care. A priori threshold for statistical significance is p-value less than 0.05.||1.15|0.94|0.481
71659627|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.79||||0.734|TWO_SIDED|95.0|-8.56|12.14|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||12.14|-8.56|0.734
71659628|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.46|||<|0.001|TWO_SIDED|95.0|46.88|70.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.03|46.88|<0.001
71659629|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.01||||0.152|TWO_SIDED|95.0|-2.57|16.59|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.59|-2.57|0.152
71659630|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.0||||0.073|TWO_SIDED|95.0|-0.83|19.82|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||19.82|-0.83|0.073
71661230|NCT01447420|142836088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.28|2.59|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia in the first month of treatment vs No anemia||2.59|0.28|
71772931|NCT03737851|143045509|OTHER|a statistical test was not performed|Odds Ratio (OR)|0.615|||||TWO_SIDED|95.0|0.266|1.421||||||Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||1.421|0.266|
71772932|NCT00859027|143045548|OTHER|||||||0.004|||||||One way ANOVA|||Percent change in femoral neck BMD from baseline||||0.004
71772933|NCT00859027|143045548|OTHER|||||||0.001|||||||One way ANOVA|||Percent change in total hip BMD from baseline||||0.001
71772934|NCT00859027|143045548|OTHER|||||||0.04|||||||One way ANOVA|||Percent change in lumbar spine BMD from baseline||||0.04
71772935|NCT00859027|143045548|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for the femoral neck BMD||||<0.01
71772936|NCT00859027|143045548|OTHER||||||<|0.01|||||||ANOVA|||Between group difference of percent change for total hip BMD||||<0.01
71772937|NCT00859027|143045549|OTHER|||||||0.015|||||||ANOVA|||Between group difference of percent change for NTX||||0.015
71772938|NCT00859027|143045549|OTHER|||||||0.01|||||||ANOVA|||Between group difference of percent change for CTX||||0.01
71831916|NCT03292913|143168510|SUPERIORITY||Risk Ratio (RR)|0.86||||0.093|TWO_SIDED|95.0|0.72|1.03|||Mixed Models Analysis|Risk ratio is adjusted for sex, age, race, site, and new to care.||Outcome measure for this analysis is a 6-month visit gap defined ashaving at least 189 days between two sequentially kept visits, post-randomization. A priori threshold for statistical significance is p-value less than 0.05.||1.03|0.72|0.093
71831917|NCT03950622|143168511|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-2.4||||0.175|TWO_SIDED|95.0|-5.8|1.1|||Miettinen & Nurminen|||Injection site redness/erythema||1.1|-5.8|0.175
71831918|NCT03950622|143168511|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|11.7|||<|0.001|TWO_SIDED|95.0|6.0|17.2|||Miettinen & Nurminen|||Injection site tenderness/pain||17.2|6.0|<0.001
71733970|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.78|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.78
71733971|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||69.42|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|69.42
71733972|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||62.63|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|62.63
71733973|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||72.55|TWO_SIDED|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.96|72.55
71733974|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||36.28|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|36.28
71772939|NCT02775903|143045582|SUPERIORITY|||||||0.1838|||||||Wald asymptotic two-sided test|||||||0.1838
71772940|NCT02775903|143045583|SUPERIORITY|||||||0.618|||||||Wald asymptotic two-sided test|||||||0.6180
71772941|NCT02775903|143045584|OTHER|P-values were not part of the formal testing.||||||0.7016|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)||||||0.7016
71772942|NCT02775903|143045585|OTHER|P-values were not part of the formal testing.||||||0.6076|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.6076
71831919|NCT03950622|143168511|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|1.3||||0.488|TWO_SIDED|95.0|-2.4|5.0|||Miettinen & Nurminen|||Injection site swelling||5.0|-2.4|0.488
71831920|NCT03950622|143168512|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-0.2||||0.888|TWO_SIDED|95.0|-2.8|2.4|||Miettinen & Nurminen|||Joint pain/arthralgia||2.4|-2.8|0.888
71831921|NCT03950622|143168512|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.1||||0.96|TWO_SIDED|95.0|-4.2|4.4|||Miettinen & Nurminen|||Tiredness/fatigue||4.4|-4.2|0.960
71889439|NCT01570244|143300579|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Odds Ratio (OR)|114.82|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|105.49|124.97|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||124.97|105.49|
71733975|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||47.44|TWO_SIDED|95.0|0.96|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.96|47.44
71733976|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||22.99|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|22.99
71772943|NCT02775903|143045586|OTHER|P-values were not part of the formal testing.||||||0.384|||||||Wald asymptotic two-sided test|||||||0.3840
71772944|NCT02775903|143045587|OTHER|P-values were not part of the formal testing.||||||0.8961|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8961
71772945|NCT02775903|143045588|OTHER|P-values were not part of the formal testing.||||||0.3591|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.3591
71772946|NCT02775903|143045589|OTHER|P-values were not part of the formal testing.||||||0.9031|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.9031
71772947|NCT02775903|143045591|OTHER|P-values were not part of the formal testing.||||||0.2409|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).||||||0.2409
71831922|NCT03950622|143168512|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|-1.4||||0.469|TWO_SIDED|95.0|-5.1|2.4|||Miettinen & Nurminen|||Headache||2.4|-5.1|0.469
71733977|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.98||||85.95|TWO_SIDED|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.94|85.95
71733978|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||60.2|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|60.20
71733979|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||81.34|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|81.34
71733980|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||63.04|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|63.04
71733981|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||69.67|TWO_SIDED|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.96|69.67
71831923|NCT03950622|143168512|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|3.4||||0.082|TWO_SIDED|95.0|-0.4|7.4|||Miettinen & Nurminen|||Muscle pain/myalgia||7.4|-0.4|0.082
71761273|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 12.||||0.0003
71761274|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0991|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.||||0.0991
71761275|NCT00611026|143024050|SUPERIORITY_OR_OTHER|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.||||0.0169
71761276|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0009
71761277|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.0279|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0279
71761278|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.2817|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||||0.2817
71761279|NCT00611026|143024051|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71761280|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0001
71761281|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0177
71761282|NCT00611026|143024051|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71761283|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0107
71761284|NCT00611026|143024051|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0005
71761285|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0011
71659631|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.3|||<|0.001|TWO_SIDED|95.0|39.38|63.21|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||63.21|39.38|<0.001
71659632|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|49.49|||<|0.001|TWO_SIDED|95.0|37.5|61.47|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||61.47|37.50|<0.001
71733982|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||39.81|TWO_SIDED|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.04|0.97|39.81
71733983|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||73.01|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|73.01
71733984|NCT02294734|142982915|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||48.97|TWO_SIDED|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.97|48.97
71772948|NCT02775903|143045592|OTHER|P-values were not part of the formal testing.||||||0.0688|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0688
71772949|NCT02775903|143045593|OTHER|P-values were not part of the formal testing.||||||0.4894|||||||Wald asymptotic two-sided test|||||||0.4894
71772950|NCT02775903|143045595|OTHER|P-values were not part of the formal testing.||||||0.0381|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0381
71772951|NCT02775903|143045597|OTHER|P-values were not part of the formal testing.||||||0.8973|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).||||||0.8973
71772952|NCT02775903|143045597|OTHER|P-values were not part of the formal testing.||||||0.0691|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).||||||0.0691
71772953|NCT04571515|143045615|SUPERIORITY||Mean Difference (Final Values)|28.3|STANDARD_ERROR_OF_MEAN|9.25||0.003|TWO_SIDED|95.0|9.9|46.6|||Emax|||||46.6|9.9|0.003
71659633|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|1.99||||0.694|TWO_SIDED|95.0|-7.91|11.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||11.89|-7.91|0.694
71772954|NCT04571515|143045615|SUPERIORITY||Mean Difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|7.94|<|0.001|TWO_SIDED|95.0|13.8|45.3|||Emax|||||45.3|13.8|<0.001
71831924|NCT03950622|143168513|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||Miettinen & Nurminen|||Vaccine-related SAEs||0.6|-0.6|
71831925|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96|||Constrained longitudinal data analysis|GMT ratio, 95% CI, and p-value are estimated from a constrained longitudinal data analysis (cLDA) model.||Serotype 1 (Shared)||0.96|0.66|<0.001
71659634|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.61|||<|0.001|TWO_SIDED|95.0|48.37|72.84|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.84|48.37|<0.001
71772955|NCT04571515|143045615|SUPERIORITY||Mean Difference (Final Values)|30.3|STANDARD_ERROR_OF_MEAN|8.04|<|0.001|TWO_SIDED|95.0|14.4|46.2|||Emax|||||46.2|14.4|<0.001
71772956|NCT04571515|143045615|SUPERIORITY||Mean Difference (Final Values)|31.1|STANDARD_ERROR_OF_MEAN|8.87|<|0.001|TWO_SIDED|95.0|13.5|48.6|||Emax|||||48.6|13.5|<0.001
71772957|NCT04571515|143045616|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.4|1.1||||||||1.1|-1.4|
71772958|NCT04571515|143045616|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-1.5|0.9||||||||0.9|-1.5|
71772959|NCT04571515|143045616|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.8|0.6||||||||0.6|-1.8|
71772960|NCT04571515|143045616|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.1|1.3||||||||1.3|-1.1|
71772961|NCT04571515|143045617|SUPERIORITY||Mean Difference (Final Values)|15.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|7.3|23.1|||Emax|||||23.1|7.3|<0.001
71772962|NCT04571515|143045617|SUPERIORITY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|9.3|22.9|||Emax|||||22.9|9.3|<0.001
71772963|NCT04571515|143045617|SUPERIORITY||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|9.7|23.4|||Emax|||||23.4|9.7|<0.001
71772964|NCT04571515|143045617|SUPERIORITY||Mean Difference (Final Values)|17.1|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|9.4|24.7|||Emax|||||24.7|9.4|<0.001
71772965|NCT04571515|143045618|SUPERIORITY|||||||0.208|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.208
71772966|NCT04571515|143045618|SUPERIORITY|||||||0.005|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.005
71733985|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.04||||2.89|TWO_SIDED|95.0|1.0|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|1.00|2.89
71761286|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0072
71772967|NCT04571515|143045618|SUPERIORITY|||||||0.192|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.192
71772968|NCT04571515|143045618|SUPERIORITY|||||||0.067|||||||Log Rank|||Time to Perceptible Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.067
71772969|NCT04571515|143045618|SUPERIORITY|||||||0.059|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.059
71772970|NCT04571515|143045618|SUPERIORITY||||||<|0.001|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||<0.001
71661231|NCT01447420|142836088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.45|||||TWO_SIDED|95.0|2.27|13.12|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs CT||13.12|2.27|
71761287|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.3713|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 1.||||0.3713
71761288|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0002
71761289|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.1485
71761290|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0040
71761291|NCT00611026|143024052|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71761292|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0060
71761293|NCT00611026|143024052|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0016
71761294|NCT00611026|143024053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-9.5|-4.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-4.7|-9.5|<0.0001
71761295|NCT00611026|143024053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.2||0.0458|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-4.8|0.0458
71761296|NCT00611026|143024053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-2.7|-6.6|<0.0001
71761297|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|3.4|7.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.||7.9|3.4|<0.0001
71761298|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0429|TWO_SIDED|95.0|0.1|4.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.||4.6|0.1|0.0429
71761299|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.9||0.0003|TWO_SIDED|95.0|1.5|5.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.||5.2|1.5|0.0003
71761300|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|4.0|9.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo: HRQL concern domain.||9.2|4.0|<0.0001
71733986|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||8.49|TWO_SIDED|95.0|0.99|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.99|8.49
71733987|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.02||||86.21|TWO_SIDED|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.07|0.98|86.21
71733988|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||75.2|TWO_SIDED|95.0|0.98|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.98|75.20
71772971|NCT04571515|143045618|SUPERIORITY|||||||0.017|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.017
71772972|NCT04571515|143045618|SUPERIORITY|||||||0.002|||||||Log Rank|||Time to Meaningful Pain Relief Subjects are censored at 24 hours if they do not report relief.||||0.002
71772973|NCT04571515|143045619|SUPERIORITY|||||||0.051|||||||Regression, Logistic|||||||0.051
71772974|NCT04571515|143045619|SUPERIORITY|||||||0.035|||||||Regression, Logistic|||||||0.035
71772975|NCT04571515|143045619|SUPERIORITY|||||||0.016|||||||Regression, Logistic|||||||0.016
71772976|NCT04571515|143045619|SUPERIORITY|||||||0.18|||||||Regression, Logistic|||||||0.180
71772977|NCT04571515|143045620|SUPERIORITY|||||||0.022|||||||Wilcoxon Rank Sum|||||||0.022
71831926|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
71831927|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.57|0.8|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 4 (Shared)||0.80|0.57|<0.001
71831928|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 5 (Shared)||0.98|0.64|<0.001
71831929|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6A (Shared)||1.19|0.84|<0.001
71889440|NCT01570244|143300580|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|171.37|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|160.2|183.33|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol||183.33|160.20|
71772978|NCT04571515|143045620|SUPERIORITY|||||||0.028|||||||Wilcoxon Rank Sum|||||||0.028
71772979|NCT04571515|143045620|SUPERIORITY|||||||0.007|||||||Wilcoxon Rank Sum|||||||0.007
71772980|NCT04571515|143045620|SUPERIORITY|||||||0.005|||||||Wilcoxon Rank Sum|||||||0.005
71772981|NCT01711372|143045663|OTHER||||||||||||||Chi-squared|||AUC or ROC for Groundskeeper Game|AUC of ROC is 0.78|||
71772982|NCT01711372|143045664|OTHER||||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76|||
71772983|NCT01711372|143045665|OTHER|AUC of ROC|||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62|||
71772984|NCT03954041|143045671|SUPERIORITY||LS mean difference|4.62|||=|0.3752|TWO_SIDED|95.0|-5.74|14.98||P-value was analyzed by ANCOVA model with covariates: treatment, interactive response technology (IRT) stratification factors at randomization, baseline total contusion volume based on central read, imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||14.98|-5.74|= 0.3752
71772985|NCT03954041|143045672|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.4|3.36||||||Statistical analysis of combined BIIB093 vs placebo||3.36|0.40|
71772986|NCT03954041|143045673|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.4306|TWO_SIDED|95.0|0.56|3.86||P-value was analyzed by ordinal logistic regression on mRS adjusting for covariates: treatment, IRT stratification factors at randomization, baseline mRS score, and baseline total contusion volume based on central read.|Regression, Logistic|||Statistical analysis of combined BIIB093 vs placebo||3.86|0.56|=0.4306
71772987|NCT03954041|143045675|SUPERIORITY||LS Mean difference|-1.53|||=|0.6478|TWO_SIDED|95.0|-8.19|5.13||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline total contusion volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||5.13|-8.19|= 0.6478
71772988|NCT03954041|143045676|SUPERIORITY||LS Mean Difference|-0.09|||=|0.9314|TWO_SIDED|95.0|-2.2|2.02||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline Glasgow Coma Scale (GCS) based on eCRF, and baseline absolute hematoma volume based on central read.|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||2.02|-2.20|=0.9314
71772989|NCT03954041|143045677|SUPERIORITY||LS Mean difference|2.18|||=|0.6569|TWO_SIDED|95.0|-7.61|11.98||P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline absolute edema volume based on central read, baseline GCS based on eCRF, and imaging modality at Hour 96 (MRI vs NCCT).|ANCOVA|||Statistical analysis of combined BIIB093 vs placebo||11.98|-7.61|= 0.6569
71831930|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.02|1.48|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 6B (Shared)||1.48|1.02|<0.001
71889441|NCT01570244|143300583|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric mean ratio|140.53|STANDARD_DEVIATION|4.6|||TWO_SIDED|90.0|136.4|144.78|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||144.78|136.40|
71889442|NCT01570244|143300584|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.28|STANDARD_DEVIATION|6.1|||TWO_SIDED|90.0|110.81|119.92|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||119.92|110.81|
71733989|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||84.29|TWO_SIDED|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.97|84.29
71733990|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||71.08|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|71.08
71733991|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||34.93|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|34.93
71733992|NCT02294734|142982916|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||25.05|TWO_SIDED|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.01|0.98|25.05
71733993|NCT02294734|142982917|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||28.51|TWO_SIDED|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.06|0.97|28.51
71733994|NCT02294734|142982917|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.01||||32.15|TWO_SIDED|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.05|0.97|32.15
71733995|NCT02294734|142982917|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|0.99||||66.51|TWO_SIDED|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.02|0.97|66.51
71733996|NCT02294734|142982917|SUPERIORITY_OR_OTHER_LEGACY||Posterior Median Ratio|1.0||||45.28|TWO_SIDED|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.|||1.03|0.98|45.28
71831931|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.9|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 7F (Shared)||0.90|0.68|<0.001
71889443|NCT01570244|143300585|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|153.85|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|145.99|162.14|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel||162.14|145.99|
71733997|NCT02294734|142982925|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.0||||0.487|TWO_SIDED|95.0|-118.5|115.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||115.3|-118.5|0.487
71733998|NCT02294734|142982925|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|60.6||||0.816|TWO_SIDED|95.0|-73.3|194.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||194.3|-73.3|0.816
71889444|NCT05617521|143300589|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients||||||0.008||||||The comparative analysis of the CIT was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||0.008
71733999|NCT02294734|142982928|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.144||||0.151|TWO_SIDED|95.0|-0.42|0.133|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.133|-0.420|0.151
71734000|NCT02294734|142982928|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.121||||0.712|TWO_SIDED|95.0|-0.305|0.551|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.551|-0.305|0.712
71734001|NCT02294734|142982929|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.18||||0.817|TWO_SIDED|95.0|-0.216|0.57|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28|||0.570|-0.216|0.817
71734002|NCT02294734|142982929|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.114||||0.697|TWO_SIDED|95.0|-0.324|0.549|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84|||0.549|-0.324|0.697
71734003|NCT02294734|142982932|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.171||||0.965|TWO_SIDED|95.0|0.988|1.388|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.388|0.988|0.965
71734004|NCT02294734|142982932|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.114||||0.913|TWO_SIDED|95.0|0.953|1.305|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.||||1.305|0.953|0.913
71734005|NCT00548717|142982938|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 1.||||0.77
71734006|NCT00548717|142982938|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 2.||||0.59
71734007|NCT00548717|142982938|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 3.||||0.92
71734008|NCT00548717|142982938|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 8.||||0.63
71734009|NCT00548717|142982938|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 12.||||0.79
71734010|NCT01571453|142983039|NON_INFERIORITY_OR_EQUIVALENCE|Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.93||0.199||95.0|-3.03|0.63||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.||0.63|-3.03|0.199
71734011|NCT01571453|142983040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.228|TWO_SIDED|95.0|-0.39|0.09||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.09|-0.39|0.228
71734012|NCT01571453|142983041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.174|TWO_SIDED|95.0|-0.35|0.06||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.06|-0.35|0.174
71734013|NCT01571453|142983042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.65||0.207|TWO_SIDED|95.0|-2.09|0.45||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.||0.45|-2.09|0.207
71734014|NCT01571453|142983043|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.272||95.0|0.84|1.86||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.86|0.84|0.272
71734015|NCT01571453|142983044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.731||95.0|0.73|1.58||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||1.58|0.73|0.731
71734016|NCT04033068|142983057|SUPERIORITY||||||=|0.2003|||||||Fisher-Freeman-Halton Test|||||||= 0.2003
71734017|NCT04033068|142983058|SUPERIORITY||||||=|0.1448|||||||Fisher-Freeman-Halton Test|||||||= 0.1448
71734018|NCT04033068|142983059|SUPERIORITY||||||=|0.9111|||||||Fisher-Freeman-Halton Test|||||||= 0.9111
71734019|NCT04033068|142983060|SUPERIORITY||||||=|1|||||||Fisher-Freeman-Halton Test|||||||= 1.0000
71734020|NCT04033068|142983062|SUPERIORITY||GMT Ratio|0.9|||=|0.999|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 0||5.5|0.2|= 0.9990
71734021|NCT04033068|142983062|SUPERIORITY||GMT Ratio|0.8|||=|0.9798|TWO_SIDED|95.0|0.1|5.2|||ANOVA|||Day 0||5.2|0.1|= 0.9798
71734022|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.2|||=|0.9958|TWO_SIDED|95.0|0.1|10.1|||ANOVA|||Day 0||10.1|0.1|= 0.9958
71734023|NCT04033068|142983062|SUPERIORITY||GMT Ratio|0.8|||=|0.9935|TWO_SIDED|95.0|0.1|5.5|||ANOVA|||Day 0||5.5|0.1|= 0.9935
71734024|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.3|||=|0.9852|TWO_SIDED|95.0|0.2|10.7|||ANOVA|||Day 0||10.7|0.2|= 0.9852
71734025|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.6|||=|0.944|TWO_SIDED|95.0|0.2|14.4|||ANOVA|||Day 0||14.4|0.2|= 0.9440
71772990|NCT00423670|143045696|SUPERIORITY_OR_OTHER||Percent difference in SVR|16.7||||0.0126|TWO_SIDED|95.0|3.5|30.0|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||30|3.5|0.0126
71772991|NCT00423670|143045696|SUPERIORITY_OR_OTHER||Percent difference in SVR|18.8||||0.0048|TWO_SIDED|95.0|5.5|32.2|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||32.2|5.5|0.0048
71772992|NCT00423670|143045696|SUPERIORITY_OR_OTHER||Percent difference in SVR|29.5|||<|0.0001|TWO_SIDED|95.0|16.5|42.5|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||42.5|16.5|<0.0001
71772993|NCT00423670|143045696|SUPERIORITY_OR_OTHER||Percent difference in SVR|37.3|||<|0.0001|TWO_SIDED|95.0|24.7|49.8|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.||||49.8|24.7|<0.0001
71772994|NCT00423670|143045697|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|5.1||||0.2864|TWO_SIDED|95.0|-4.2|14.3|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||14.3|-4.2|0.2864
71772995|NCT00423670|143045698|SUPERIORITY_OR_OTHER||Percent difference in SVR rates|15.6||||0.0009|TWO_SIDED|95.0|6.5|24.8|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.||||24.8|6.5|0.0009
71772996|NCT02131532|143045712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.25|STANDARD_ERROR_OF_MEAN|3.321||0.03|TWO_SIDED|95.0|1.398|17.102|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in fatigue scores between baseline and three-month assessments||17.102|1.398|0.03
71772997|NCT02131532|143045713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.625|STANDARD_ERROR_OF_MEAN|1.401||0.1|TWO_SIDED|95.0|-0.687|5.937|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in depression scores between baseline and three-month assessments||5.937|-0.687|0.10
71772998|NCT02131532|143045714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.313||0.45|TWO_SIDED|95.0|-0.991|0.491|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in independence scores between baseline and three-month assessments||0.491|-0.991|0.45
71772999|NCT02131532|143045715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.875|STANDARD_ERROR_OF_MEAN|5.03||0.03|TWO_SIDED|95.0|-25.769|-1.981|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in scores of general rating of recovery between baseline and three-month assessments||-1.981|-25.769|0.03
71773000|NCT02131532|143045716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.781|STANDARD_ERROR_OF_MEAN|5.594||0.89|TWO_SIDED|95.0|-14.01|12.448|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in physical strength scores between baseline and three-month assessments||12.448|-14.010|0.89
71773001|NCT02131532|143045717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.105|STANDARD_ERROR_OF_MEAN|2.378||0.009|TWO_SIDED|95.0|-7.729|3.519|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in memory and thinking scores between baseline and three-month assessments||3.519|-7.729|0.009
71831932|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.7|0.94|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 9V (Shared)||0.94|0.70|<0.001
71831933|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 14 (Shared)||0.89|0.64|<0.001
71831934|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.91|1.26|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 18C (Shared)||1.26|0.91|<0.001
71831935|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.7|0.93|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19A (Shared)||0.93|0.70|<0.001
71773002|NCT02131532|143045718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.403|STANDARD_ERROR_OF_MEAN|5.168||0.009|TWO_SIDED|95.0|-30.624|-6.183|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in emotion scores between baseline and three-month assessments||-6.183|-30.624|0.009
71773003|NCT02131532|143045719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.142|STANDARD_ERROR_OF_MEAN|3.696||0.1|TWO_SIDED|95.0|-15.883|1.598|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in communication scores between baseline and three-month assessments||1.598|-15.883|0.10
71773004|NCT02131532|143045720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.25||0.09|TWO_SIDED|95.0|-5.455|0.455|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in daily activities scores between baseline and three-month assessments||0.455|-5.455|0.09
71773005|NCT02131532|143045721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.821|STANDARD_ERROR_OF_MEAN|1.382||0.03|TWO_SIDED|95.0|-7.091|-0.551|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in mobility scores between baseline and three-month assessments||-0.551|-7.091|0.03
71831936|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.76|1.02|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 19F (Shared)||1.02|0.76|<0.001
71831937|NCT03950622|143168514|NON_INFERIORITY|The statistical criterion for noninferiority requires the lower bound of the 2-sided 95% confidence interval (CI) of the OPA GMT ratio (V114/ Prevnar 13™) to be greater than 0.5.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.96|1.44|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 23F (Shared)||1.44|0.96|<0.001
71831938|NCT03950622|143168514|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|31.83|||<|0.001|TWO_SIDED|95.0|25.35|39.97|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 22F (Unique to V114)||39.97|25.35|<0.001
71889445|NCT05617521|143300590|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.|||||<|0.001||||||For the comparison of abdominal pressure, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||<0.001
71889446|NCT05617521|143300591|SUPERIORITY||||||<|0.001||||||The comparative analysis of the CIL was previously subjected to normality evaluation by the Shapiro-Wilk test. According to the rejection of normal distribution, comparative data analysis has been performed with a two-way Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||||||<0.001
71889447|NCT05617521|143300592|SUPERIORITY|||||||0.321|||||||Chi-squared|||||||0.321
71889448|NCT05617521|143300593|SUPERIORITY|||||||0.75|||||||Fisher Exact|||||||0.75
71889449|NCT05617521|143300594|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.005
71889450|NCT05617521|143300595|OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
71889451|NCT05617521|143300597|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71734026|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.2|||=|0.9943|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 28||5.5|0.2|= 0.9943
71734027|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.0|||=|0.9999|TWO_SIDED|95.0|0.2|5.1|||ANOVA|||Day 28||5.1|0.2|= 0.9999
71734028|NCT04033068|142983062|SUPERIORITY||GMT Ratio|2.2|||=|0.6476|TWO_SIDED|95.0|0.4|14.3|||ANOVA|||Day 28||14.3|0.4|= 0.6476
71831939|NCT03950622|143168514|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 2.0.|GMT Ratio|7.11|||<|0.001|TWO_SIDED|95.0|6.07|8.32|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 33F (Unique to V114)||8.32|6.07|<0.001
71831940|NCT03950622|143168515|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1.|Percentage Point Difference|57.1|||<|0.001|TWO_SIDED|95.0|52.0|61.8|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 22F (Unique to V114)||61.8|52.0|<0.001
71734029|NCT04033068|142983062|SUPERIORITY||GMT Ratio|0.8|||=|0.9911|TWO_SIDED|95.0|0.2|4.3|||ANOVA|||Day 28||4.3|0.2|= 0.9911
71889452|NCT05617521|143300598|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71734030|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.9|||=|0.7647|TWO_SIDED|95.0|0.3|12.0|||ANOVA|||Day 28||12.0|0.3|= 0.7647
71889453|NCT05617521|143300599|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71889454|NCT05617521|143300600|SUPERIORITY|Sample size was assessed over the primary outcome of the study based on pre-experimental data estimation. It was calculated that 142 participants were needed to detect a 60-second difference in CIT, with 90% power and two-side alpha 0.05. It was found that 186 participants were needed to detect a 20% reduction in the use of ancillary maneuvers. As a preventive measure in case of withdrawal or exclusion, the sample was expanded by 10%, a total of 206 patients.||||||0.01||||||For the comparison of position change, Pearson chi-square test was used. The statistical significance level was accepted as p \<0.05|Chi-squared|||||||0.01
71889455|NCT05617521|143300601|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71889456|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|12.9|||<|0.001|TWO_SIDED|95.0|9.5|16.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||16.3|9.5|<0.001
71889457|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.6|||<|0.001|TWO_SIDED|95.0|4.4|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.4|<0.001
71889458|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|10.8|||<|0.001|TWO_SIDED|95.0|7.4|14.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||14.2|7.4|<0.001
71659635|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.58||||0.135|TWO_SIDED|95.0|-2.05|15.2|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||15.20|-2.05|0.135
71659636|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|14.74||||0.002|TWO_SIDED|95.0|5.5|23.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|5.50|0.002
71659637|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.82|||<|0.001|TWO_SIDED|95.0|41.31|66.32|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.32|41.31|<0.001
71659638|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|45.93|||<|0.001|TWO_SIDED|95.0|33.21|58.66|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.66|33.21|<0.001
71659639|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.18||||0.091|TWO_SIDED|95.0|-1.32|17.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.69|-1.32|0.091
71734031|NCT04033068|142983062|SUPERIORITY||GMT Ratio|2.3|||=|0.6447|TWO_SIDED|95.0|0.3|15.8|||ANOVA|||Day 28||15.8|0.3|= 0.6447
71734032|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.3|||=|0.9638|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 56||5.3|0.3|= 0.9638
71734033|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.7|||=|0.7837|TWO_SIDED|95.0|0.4|7.7|||ANOVA|||Day 56||7.7|0.4|= 0.7837
71831941|NCT03950622|143168515|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the differences \[V114 - Prevnar 13™\] between the proportions of participants with a ≥4-fold rise from prevaccination \[Day 1\] to 30 days postvaccination \[Day 30\] to be greater than 0.1)|Percentage Point Difference|50.5|||<|0.001|TWO_SIDED|95.0|45.9|54.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 33F (Unique to V114)||54.9|45.9|<0.001
71659640|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|60.0|||<|0.001|TWO_SIDED|95.0|47.59|72.42|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||72.42|47.59|<0.001
71659641|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.03||||0.159|TWO_SIDED|95.0|-2.36|14.43|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.43|-2.36|0.159
71659642|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.32|||<|0.001|TWO_SIDED|95.0|6.23|24.41|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.41|6.23|<0.001
71659643|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|53.79|||<|0.001|TWO_SIDED|95.0|41.08|66.5|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||66.50|41.08|<0.001
71659644|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.76|||<|0.001|TWO_SIDED|95.0|31.72|57.81|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.81|31.72|<0.001
71659645|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.28||||0.052|TWO_SIDED|95.0|-0.08|18.64|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.64|-0.08|0.052
71659646|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|57.57|||<|0.001|TWO_SIDED|95.0|44.75|70.39|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||70.39|44.75|<0.001
71734034|NCT04033068|142983062|SUPERIORITY||GMT Ratio|2.9|||=|0.3427|TWO_SIDED|95.0|0.5|15.3|||ANOVA|||Day 56||15.3|0.5|= 0.3427
71734035|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.3|||=|0.9578|TWO_SIDED|95.0|0.3|5.8|||ANOVA|||Day 56||5.8|0.3|= 0.9578
71734036|NCT04033068|142983062|SUPERIORITY||GMT Ratio|2.2|||=|0.5637|TWO_SIDED|95.0|0.4|11.7|||ANOVA|||Day 56||11.7|0.4|= 0.5637
71734037|NCT04033068|142983062|SUPERIORITY||GMT Ratio|1.7|||=|0.8471|TWO_SIDED|95.0|0.3|9.6|||ANOVA|||Day 56||9.6|0.3|= 0.8471
71734038|NCT02039856|142983076|SUPERIORITY|Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.|Odds Ratio (OR)|0.913|STANDARD_ERROR_OF_MEAN|0.175||0.637|TWO_SIDED|95.0|0.627|1.33|||difference-in-differences analysis||The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.|Change in the odds of achieving a higher WH-PACT element.||1.33|0.627|0.637
71761301|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.0795|TWO_SIDED|95.0|-0.3|4.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.||4.9|-0.3|0.0795
71734039|NCT02039856|142983077|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.1195||0.006|TWO_SIDED|95.0|0.1|0.57|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in gender sensitivity score between EBQI and control over time||0.57|0.10|0.006
71734040|NCT02039856|142983078|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.2253||0.055|TWO_SIDED|95.0|-0.01|0.87|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in team functioning score between EBQI and control over time.||0.87|-0.01|0.055
71734041|NCT02039856|142983079|SUPERIORITY|We adjusted our analysis using the population weights, which were the product of design weights and non-response weights|Odds Ratio (OR)|0.36|STANDARD_ERROR_OF_MEAN|0.1922||0.058|TWO_SIDED|95.0|0.13|1.04|||Regression, Logistic||The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.|||1.04|0.13|0.058
71734042|NCT02039856|142983080|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.56||0.008|TWO_SIDED|95.0|0.14|2.36|||Regression, Linear||The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient primary care visits between EBQI and control over time||2.36|0.14|0.008
71734043|NCT02039856|142983081|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.413||0|TWO_SIDED|95.0|0.88|2.51|||Regression, Linear||The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient visits to women's health care between EBQI and control over time||2.51|0.88|0.000
71734044|NCT02039856|142983082|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.068||0.794|TWO_SIDED|95.0|-0.15|0.12|||Regression, Linear||The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient hospitalization for any cause between EBQI and control over time||0.12|-0.15|0.794
71734045|NCT02039856|142983083|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.15||0.888|TWO_SIDED|95.0|-0.265|0.306|||Regression, Linear||The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of emergency room visits for any cause between EBQI and control over time||0.306|-0.265|0.888
71659647|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.06||||0.147|TWO_SIDED|95.0|-2.13|14.25|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.25|-2.13|0.147
71734046|NCT02409342|142983090|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.595||||0.0106|TWO_SIDED|95.0|0.398|0.89|||Log Rank|||TC3 or IC3-WT Population||0.890|0.398|0.0106
71734047|NCT02409342|142983091|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.868||||0.3091|TWO_SIDED|95.0|0.661|1.14|||Log Rank|||TC2/3 or IC2/3-WT Population||1.140|0.661|0.3091
71734048|NCT02409342|142983091|SUPERIORITY|Stratified analysis. OS was tested hierarchically in the efficacy analysis populations.|Hazard Ratio (HR)|0.845||||0.107|TWO_SIDED|95.0|0.688|1.037||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC/1/2/3-WT||1.037|0.688|0.1070
71734049|NCT02409342|142983092|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.63||||0.007|TWO_SIDED|95.0|0.449|0.884||P-value is descriptive as it was not formally tested.|Log Rank|||TC3 or IC3-WT Population||0.884|0.449|0.0070
71734050|NCT02409342|142983093|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.641||||0.0004|TWO_SIDED|95.0|0.501|0.82||P-value is descriptive as it was not formally tested.|Log Rank|||TC2/3 or IC2/3-WT Population||0.820|0.501|0.0004
71734051|NCT02409342|142983093|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.716||||0.0004|TWO_SIDED|95.0|0.595|0.863||P-value is descriptive as it was not formally tested.|Log Rank|||TC1/2/3 or IC1/2/3-WT Population||0.863|0.595|0.0004
71734052|NCT02409342|142983094|SUPERIORITY|Stratified Analysis|Difference in ORR|9.75|||||TWO_SIDED|95.0|-4.07|23.56||||||TC3 or IC3-WT Population||23.56|-4.07|
71734053|NCT02409342|142983095|SUPERIORITY|Stratified analysis|Difference in ORR|1.64|||||TWO_SIDED|95.0|-9.14|12.42||||||TC2/3 or IC2/3-WT Population||12.42|-9.14|
71734054|NCT02409342|142983095|SUPERIORITY|Stratified analysis|Difference in ORR|-0.72|||||TWO_SIDED|95.0|-8.84|7.39||||||TC1/2/3 or IC1/2/3-WT Population||7.39|-8.84|
71734055|NCT02409342|142983096|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.365|||||TWO_SIDED|95.0|0.166|0.8||||||TC3 or IC3-WT Population||0.800|0.166|
71734056|NCT02409342|142983097|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.235|||||TWO_SIDED|95.0|0.135|0.409||||||TC2/3 or IC2/3-WT Population||0.409|0.135|
71734057|NCT02409342|142983097|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.284|||||TWO_SIDED|95.0|0.19|0.424||||||TC1/2/3 or IC1/2/3-WT Population||0.424|0.190|
71734058|NCT02409342|142983098|SUPERIORITY||Difference in Event Free Rate|14.26|||||TWO_SIDED|95.0|-0.03|28.55||||||1-Year TC3 or IC3-WT Population||28.55|-0.03|
71734059|NCT02409342|142983099|SUPERIORITY||Difference in Event Free Rate|20.7|||||TWO_SIDED|95.0|2.94|38.47||||||2-Years TC3 or IC3-WT Population||38.47|2.94|
71734060|NCT02409342|142983100|SUPERIORITY||Difference in Event Free Rate|4.74|||||TWO_SIDED|95.0|-5.93|15.4||||||1-Year TC2/3 or IC2/3-WT Population||15.40|-5.93|
71773006|NCT02131532|143045722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.875|STANDARD_ERROR_OF_MEAN|3.264||0.58|TWO_SIDED|95.0|-9.594|5.844||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in hand function scores between baseline and three-month assessments||5.844|-9.594|0.58
71773007|NCT02131532|143045723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.576|STANDARD_ERROR_OF_MEAN|3.691||0.006|TWO_SIDED|95.0|-23.304|-5.847||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in social activity scores between baseline and three-month assessments||-5.847|-23.304|0.006
71773008|NCT00450112|143045728|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Fisher Exact|||||||>0.1
71831942|NCT03950622|143168516|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the OPA GMT ratio \[V114/ Prevnar 13™\] to be greater than 1.2.|GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.38|1.85|||cLDA|GMT ratio, 95% CI, and p-value are estimated from a cLDA model.||Serotype 3 (Shared)||1.85|1.38|<0.001
71831943|NCT03950622|143168517|SUPERIORITY|The statistical criterion for superiority requires the lower bound of the 2-sided 95% CI of the difference(V114 - Prevnar 13™) between the proportions of participants with a ≥4-fold rise from prevaccination (Day 1) to 30 days postvaccination (Day 30) to be greater than 0.|Percentage Point Difference|11.5|||<|0.001|TWO_SIDED|95.0|6.0|16.9|||Miettinen & Nurminen|Estimated difference, 95% CI, and p-value are based on the stratified Miettinen \& Nurminen method.||Serotype 3 (Shared) ≥4-Fold Rise in OPA||16.9|6.0|<0.001
71831944|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a constrained longitudinal data analysis (cLDA) model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 1 (Shared)||0.83|0.62|
71773009|NCT00450112|143045729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
71661232|NCT01447420|142836088|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||||TWO_SIDED|95.0|1.19|13.61|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs TT||13.61|1.19|
71734061|NCT02409342|142983100|SUPERIORITY||Difference in Event Free Rate|5.06|||||TWO_SIDED|95.0|-3.27|13.4||||||1-Year TC1/2/3 or IC1/2/3-WT Population||13.40|-3.27|
71734062|NCT02409342|142983101|SUPERIORITY||Difference in Event Free Rate|8.73|||||TWO_SIDED|95.0|-1.99|19.45||||||2-Years TC2/3 or IC2/3-WT Population||19.45|-1.99|
71734063|NCT02409342|142983101|SUPERIORITY||Difference in Event Free Rate|10.94|||||TWO_SIDED|95.0|2.83|19.04||||||2-Years TC1/2/3 or IC1/2/3-WT Population||19.04|2.83|
71734064|NCT02409342|142983102|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.142|||||TWO_SIDED|95.0|0.657|1.984||||||Cough in TC3 or IC3-WT Populations||1.984|0.657|
71734065|NCT02409342|142983102|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.891|||||TWO_SIDED|95.0|0.555|1.43||||||Dyspnoea in TC3 or IC3-WT Populations||1.430|0.555|
71734066|NCT02409342|142983102|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.229|||||TWO_SIDED|95.0|0.737|2.049||||||Chest pain in TC3 or IC3-WT Populations||2.049|0.737|
71734067|NCT02409342|142983104|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.477|2.03||||||Cough for TC3 or IC3-WT Populations||2.030|0.477|
71734068|NCT02409342|142983104|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|0.955|||||TWO_SIDED|95.0|0.569|1.604||||||Dyspnea for TC3 or IC3-WT Populations||1.604|0.569|
71734069|NCT02409342|142983104|SUPERIORITY|Stratified analysis|Hazard Ratio (HR)|1.024|||||TWO_SIDED|95.0|0.472|2.222||||||Chest pain for TC3 or IC3-WT Populations||2.222|0.472|
71734070|NCT02409342|142983105|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.707|||||TWO_SIDED|95.0|0.5|1.0||||||SP263 \>=50%-WT Population||1.000|0.500|
71734071|NCT02409342|142983105|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.502|0.956||||||SP263 \>=25%-WT Population||0.956|0.502|
71734072|NCT02409342|142983105|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.579|1.018||||||SP263 \>=1%-WT Population||1.018|0.579|
71734073|NCT02409342|142983106|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.674|||||TWO_SIDED|95.0|0.511|0.89||||||SP263 \>=50%-WT Population||0.890|0.511|
71734074|NCT02409342|142983106|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.698|||||TWO_SIDED|95.0|0.539|0.904||||||SP263 \>=25%-WT Population||0.904|0.539|
71734075|NCT02409342|142983106|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.725|||||TWO_SIDED|95.0|0.577|0.91||||||SP263 \>=1%-WT Population||0.910|0.577|
71734076|NCT02409342|142983107|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.867|||||TWO_SIDED|95.0|0.578|1.301||||||bTMB \>=10-WT Population||1.301|0.578|
71734077|NCT02409342|142983107|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.748|||||TWO_SIDED|95.0|0.414|1.351||||||bTMB \>=16-WT Population||1.351|0.414|
71734078|NCT02409342|142983107|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.362|1.638||||||bTMB \>=20-WT Population||1.638|0.362|
71773010|NCT00450112|143045729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
71773011|NCT00450112|143045730|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
71773012|NCT00450112|143045730|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
71831945|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.33|1.71||||||Serotype 3 (Shared)||1.71|1.33|
71831946|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 4 (Shared)||0.83|0.62|
71734079|NCT02409342|142983108|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.525|1.052||||||bTMB \>=10-WT Population||1.052|0.525|
71734080|NCT02409342|142983108|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.553|||||TWO_SIDED|95.0|0.331|0.924||||||bTMB \>=16-WT Population||0.924|0.331|
71734081|NCT02409342|142983108|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.295|1.062||||||bTMB \>=20-WT Population||1.062|0.295|
71734082|NCT04327024|142983116|OTHER||Mean Difference (Final Values)|-0.1||||0.862|TWO_SIDED|95.0|-1.28|1.08|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.08|-1.28|0.862
71734083|NCT04327024|142983117|OTHER||Mean Difference (Final Values)|0.44||||0.472|TWO_SIDED|95.0|-0.76|1.64|||ANCOVA|Model included change from baseline as the dependent variable, treatment as the independent variable and baseline peak VO2 as covariate.||||1.64|-0.76|0.472
71734084|NCT04327024|142983118|OTHER||Mean Difference (Final Values)|3.15||||0.287|TWO_SIDED|95.0|-2.65|8.94|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs placebo) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||8.94|-2.65|0.287
71734085|NCT04327024|142983119|OTHER||Mean Difference (Final Values)|-0.15||||0.96|TWO_SIDED|95.0|-5.9|5.61|||Mixed Models Analysis|Model included treatment as the independent variable and visit, visit by treatment, and baseline KCCQ-TSS as covariates.||"H0: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) = 0 Ha: Difference in mean change from baseline in KCCQ-TSS (verinurad + allopurinol vs allopurinol) ≠ 0~A hierarchical test sequence was used for the confirmatory analysis of the primary and secondary objectives in order to address the issue of multiple testing and control the Type I error rate at an overall two-sided 0.05 level."||5.61|-5.90|0.960
71734086|NCT01192568|142983123|SUPERIORITY||Mean Difference (Final Values)|14.22|STANDARD_ERROR_OF_MEAN|4.612||0.0928|TWO_SIDED|95.0|-2.45|30.9|||ANCOVA|||||30.90|-2.45|0.0928
71734087|NCT01192568|142983124|SUPERIORITY||Mean Difference (Final Values)|34.92|STANDARD_ERROR_OF_MEAN|8.089||0.0054|TWO_SIDED|95.0|11.13|58.7|||ANCOVA|||||58.70|11.13|0.0054
71734088|NCT01192568|142983125|SUPERIORITY||Mean Difference (Final Values)|32.59|STANDARD_ERROR_OF_MEAN|13.215||0.1739|TWO_SIDED|95.0|-14.89|80.07|||ANCOVA|||||80.07|-14.89|0.1739
71831947|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96||||||Serotype 5 (Shared)||0.96|0.70|
71734089|NCT01192568|142983126|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.117||0.266|TWO_SIDED|95.0|-0.53|0.15|||ANCOVA|||Results from a pre-specified test (Kolmogorov-Smirnov test p \<= 0.05) determined that the Pre-Am3 and Post-Am3 OTG data should be analyzed separately for the primary analysis.||0.15|-0.53|0.2660
71734090|NCT01192568|142983126|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.007|TWO_SIDED|95.0|-1.13|-0.21|||t-test, 2 sided|||||-0.21|-1.13|0.0070
71734091|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.|GMC ratio|0.89|||||TWO_SIDED|95.0|0.74|1.07|||ANOVA|||The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.||1.07|0.74|
71734092|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.84|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.||1.23|0.84|
71761302|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|2.1|6.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.||6.3|2.1|<0.0001
71831948|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.87|1.21||||||Serotype 6A (Shared)||1.21|0.87|
71831949|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.17|1.64||||||Serotype 6B (Shared)||1.64|1.17|
71831950|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89||||||Serotype 7F (Shared)||0.89|0.66|
71661233|NCT04420273|142836094|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||1-month survey||||<0.001
71831951|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|1.0||||||Serotype 9V (Shared)||1.00|0.75|
71831952|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 14 (Shared)||0.89|0.65|
71831953|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05||||||Serotype 18C (Shared)||1.05|0.77|
71831954|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 19A (Shared)||0.97|0.73|
71734093|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.||1.15|0.83|
71734094|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.69|1.26|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.||1.26|0.69|
71734095|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.82|1.13|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.||1.13|0.82|
71734096|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.78|1.16|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.||1.16|0.78|
71734097|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.||1.21|0.85|
71734098|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.|GMC ratio|1.61|||||TWO_SIDED|95.0|1.28|2.03|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.||2.03|1.28|
71734099|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.|GMC ratio|1.06|||||TWO_SIDED|95.0|0.82|1.36|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.||1.36|0.82|
71734100|NCT00652951|142983127|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.|GMC ratio|0.92|||||TWO_SIDED|95.0|0.7|1.23|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.||1.23|0.7|
71734101|NCT00652951|142983128|NON_INFERIORITY|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.|GMC ratio|0.91|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA|||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.||1.06|0.77|
71734102|NCT01206582|142983170|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0002
71734103|NCT01206582|142983170|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||ANCOVA|||Comparison for day 7||||0.008
71734104|NCT01206582|142983171|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Comparison for day 3||||0.0003
71734105|NCT01206582|142983178|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
71734106|NCT01206582|142983179|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Comparison for Day 7||||<0.05
71831955|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.05||||||Serotype 19F (Shared)||1.05|0.78|
71661234|NCT04420273|142836094|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||2- months||||<0.001
71734107|NCT01206582|142983180|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Comparison for Platelets on Day 4||||0.01
71734108|NCT00568126|142983191|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|2.1||||0.55|TWO_SIDED|95.0|0.18|25.2||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||25.2|0.18|0.55
71734109|NCT00568126|142983192|SUPERIORITY|Remission rates for maca vs. placebo were compared by chi-squared and by odds ratio (with 95% confidence interval).|Odds Ratio (OR)|1.71||||0.47|TWO_SIDED|95.0|0.4|7.34||P values above are calculated. No multiple comparisons. Threshold for significance set a priori as P\<0.05.|Chi-squared||Odds ratio for attaining remission while taking maca vs taking placebo|"Treatment groups were compared based on percentage reaching remission thresholds per scale: a total score of 12 (minimally diminished) or less on the MGH-SFQ scale, and a total score of 10 (very strong/very easily/very satisfying) or less on the ASEX."||7.34|0.40|0.47
71734110|NCT00151476|142983227|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|14.49||||||95.0|3.48|301.64|||||Kaplan-Meier Estimate of Time to Event (months).|"Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.~Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.~Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints"||301.64|3.48|
71734111|NCT00151476|142983227|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.06||||||95.0|3.48|11.76|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||11.76|3.48|
71889459|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|7.8|||<|0.001|TWO_SIDED|95.0|4.6|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||10.9|4.6|<0.001
71734112|NCT00151476|142983227|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.52||||||95.0|3.48|14.49|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||14.49|3.48|
71734113|NCT00151476|142983228|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|5.98||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
71734114|NCT00151476|142983228|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||33.77|0.00|
71734115|NCT00151476|142983229|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|137.34||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.||183.48|104.73|
71734116|NCT00151476|142983229|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|169.94||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||183.48|104.73|
71734117|NCT00151476|142983230|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|11.28||||||95.0|9.07|38.24|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||38.24|9.07|
71734118|NCT00151476|142983231|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.63||||||95.0|8.05|48.03|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||48.03|8.05|
71734119|NCT00151476|142983231|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|40.21||||||95.0|8.31|105.68|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||105.68|8.31|
71734120|NCT00151476|142983231|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|16.03|56.34|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||56.34|16.03|
71734121|NCT00151476|142983231|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|20.22||||||95.0|12.35|40.31|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.||40.31|12.35|
71734122|NCT00151476|142983233|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|21.22||||||95.0|4.07|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|4.07|
71773013|NCT00450112|143045731|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
71734123|NCT00151476|142983233|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|3.68|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.||64.16|3.68|
71734124|NCT02868229|142983286|SUPERIORITY||Differences of LS Means|-5.666||||0.002|TWO_SIDED|95.0|-9.082|-2.25|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-2.250|-9.082|0.002
71734125|NCT02868229|142983286|SUPERIORITY||Differences of LS Means|-6.913|||<|0.001|TWO_SIDED|95.0|-10.613|-3.214|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-3.214|-10.613|<0.001
71773014|NCT00450112|143045731|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
71889460|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|7.6|||<|0.001|TWO_SIDED|95.0|4.2|11.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||11.0|4.2|<0.001
71889461|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|10.4|||<|0.001|TWO_SIDED|95.0|7.2|13.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||13.6|7.2|<0.001
71889462|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|5.2||||0.002|TWO_SIDED|95.0|1.9|8.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.6|1.9|0.002
71889463|NCT00792298|143300603|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|4.7||||0.003|TWO_SIDED|95.0|1.6|7.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.8|1.6|0.003
71889464|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-36.8|||<|0.001|TWO_SIDED|95.0|-49.4|-24.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-24.3|-49.4|<0.001
71889465|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.9|||<|0.001|TWO_SIDED|95.0|-42.1|-15.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.7|-42.1|<0.001
71659648|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.3|||<|0.001|TWO_SIDED|95.0|6.39|24.21|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.21|6.39|<0.001
71659649|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.32|||<|0.001|TWO_SIDED|95.0|38.16|64.48|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.48|38.16|<0.001
71734126|NCT02868229|142983286|SUPERIORITY||Differences of LS Means|-9.591|||<|0.001|TWO_SIDED|95.0|-13.217|-5.965|||ANCOVA|||The P-value was obtained from rank transformed analysis of covariance (ANCOVA) model, where the rank transformed change from baseline (CFB) values as the response variable and treatments as a factor and the rank transformed baseline value as its covariate.||-5.965|-13.217|<0.001
71659650|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.28|||<|0.001|TWO_SIDED|95.0|28.74|55.82|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||55.82|28.74|<0.001
71734127|NCT02883062|142983449|SUPERIORITY|||||||0.36|||||||Generalized estimating equation (GEE)|||||||0.36
71734128|NCT02883062|142983450|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||||||0.018
71734129|NCT02888743|142983458|SUPERIORITY||Difference between proportions|0.0||||0.99|TWO_SIDED|90.0|-14.6|14.6|||Chi-squared||Arm A compared with Arm C; normal approximation for confidence interval|||14.6|-14.6|0.99
71734130|NCT02888743|142983458|SUPERIORITY||Difference between proportions|-3.8||||0.64|TWO_SIDED|90.0|-17.3|9.6|||Chi-squared||Arm B compared with Arm C; normal approximation used for confidence interval.|||9.6|-17.3|0.64
71734131|NCT02888743|142983459|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.92|TWO_SIDED|90.0|0.6|1.58|||Regression, Cox|||||1.58|0.60|0.92
71734132|NCT02888743|142983459|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.55|TWO_SIDED|90.0|0.5|1.38|||Regression, Cox|||||1.38|0.50|0.55
71734133|NCT02888743|142983460|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.24|TWO_SIDED|90.0|0.3|1.22|||Regression, Cox|||||1.22|0.30|0.24
71734134|NCT02888743|142983460|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.44|TWO_SIDED|90.0|0.36|1.45|||Regression, Cox|||||1.45|0.36|0.44
71734135|NCT02888743|142983464|SUPERIORITY|||||||0.68||||||Unadjusted p-value.|Wilcoxon (Mann-Whitney)|||||||0.68
71734136|NCT04816721|142983467|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.96||||0.1249|TWO_SIDED|95.0|-2.21|0.28|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.28|-2.21|0.1249
71734137|NCT04816721|142983467|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-1.41||||0.058|TWO_SIDED|95.0|-2.88|0.05|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.05|-2.88|0.0580
71734138|NCT04816721|142983467|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.43||||0.5877|TWO_SIDED|95.0|-2.02|1.16|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||1.16|-2.02|0.5877
71734139|NCT04816721|142983467|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.84||||0.2932|TWO_SIDED|95.0|-0.76|2.43|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||2.43|-0.76|0.2932
71734140|NCT04816721|142983468|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
71734141|NCT04816721|142983468|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.4728|TWO_SIDED|95.0|-1.23|0.58|||Mixed-effect Model of Repeated Measures|||Day 5: EDP-938 Versus Placebo||0.58|-1.23|0.4728
71831956|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 23F (Shared)||1.28|0.92|
71734142|NCT04816721|142983468|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.7||||0.2058|TWO_SIDED|95.0|-1.79|0.39|||Mixed-effect Model of Repeated Measures|||Day 9: EDP-938 Versus Placebo||0.39|-1.79|0.2058
71734143|NCT04816721|142983468|OTHER|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|0.33||||0.5391|TWO_SIDED|95.0|-0.74|1.41|||Mixed-effect Model of Repeated Measures|||Day 14: EDP-938 Versus Placebo||1.41|-0.74|0.5391
71734144|NCT04816721|142983470|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.17||||0.6574|TWO_SIDED|95.0|-0.93|0.59|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 3: EDP-938 Versus Placebo||0.59|-0.93|0.6574
71734145|NCT04816721|142983470|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-0.67||||0.5359|TWO_SIDED|95.0|-2.81|1.47|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 5: EDP-938 Versus Placebo||1.47|-2.81|0.5359
71734146|NCT04816721|142983470|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-2.73||||0.3029|TWO_SIDED|95.0|-7.95|2.5|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 9: EDP-938 Versus Placebo||2.50|-7.95|0.3029
71734147|NCT04816721|142983470|SUPERIORITY|The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation was used to estimate the denominator degrees of freedom.|Least Squares Mean Difference|-3.64||||0.3871|TWO_SIDED|95.0|-11.98|4.69|||Mixed-effect Model of Repeated Measures|||Day 1 through Day 14: EDP-938 Versus Placebo||4.69|-11.98|0.3871
71734148|NCT00026312|142983498|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6803||||0.1016|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.1016
71734149|NCT00026312|142983499|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|2.6176||||0.1057|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.1057
71734150|NCT00026312|142983502|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.0262|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The number of courses of therapy delivered or patients randomized to Regimen B - RA + Immunotherapy and non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease, were compared using the Wilcoxon rank-sum test.||||0.0262
71734151|NCT00026312|142983503|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|3.4471||||0.0634|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.||||0.0634
71831957|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.62|||||TWO_SIDED|95.0|9.37|12.03||||||Serotype 22F (Unique to V114)||12.03|9.37|
71659651|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.27||||0.049|TWO_SIDED|95.0|0.04|18.49|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.49|0.04|0.049
71734152|NCT00026312|142983503|SUPERIORITY_OR_OTHER_LEGACY||Log-Rank Test Statistic|4.1362||||0.042|TWO_SIDED|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.||||0.042
71734153|NCT01638546|142983516|OTHER||||||||||||||||||The study will be performed as a double-blind, placebo controlled, randomized Phase II in patients with relapsed sensitive or refractory SCLC. Eligible patients will be randomized 1:1 to one of two treatment arms: ABT-888 and temozolomide as the investigational arm, versus placebo and temozolomide as the control arm. The randomization will be stratified by center and by type or relapse (sensitive vs. refractory). The primary objective is to compare the two treatment regimens with respect to efficacy, expressed as Progression Free Survival (PFS) at 4 months post-randomization. PFS will be calculated as proportion of patients alive and without evidence of disease at 4 months after randomization.|||
71734154|NCT02250664|142983545|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
71734155|NCT02250664|142983545|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANOVA|||The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.|Group difference = 0.03 mg nicotine - 0.8 mg nicotine|-5.57|-9.51|<0.0001
71734156|NCT03847909|142983546|SUPERIORITY|P value is from an ANCOVA model with treatment group as the main effect, age category, baseline eGFR category, baseline Uox value as covariates for adjustment.|Difference of Least Mean Square|5171.7|STANDARD_ERROR_OF_MEAN|1144.07|<|0.0001|TWO_SIDED|95.0|2929.3|7414.2|||ANCOVA|||||7414.2|2929.3|<0.0001
71734157|NCT00117793|142983583|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb volume was analyzed using repeated measures one-way analyses of variance.||||||>0.05
71734158|NCT00117793|142983584|SUPERIORITY_OR_OTHER||||||=|0.0056||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on activity level was analyzed using repeated measures one-way analyses of variance.||||||=0.0056
71734159|NCT00117793|142983585|SUPERIORITY_OR_OTHER||||||=|0.0021||95.0||||Statistical significance was set a-priori at p \< 0.05.|Mixed Models Analysis|The effect of study limb on limb pistoning was analyzed using repeated measures one-way analyses of variance.||||||=0.0021
71734160|NCT04268173|142983589|EQUIVALENCE|A two sample t-test was conducted to test the null hypothesis that the pre-intervention mean response was equivalent to the post-intervention mean response in the Prevention Navigation group. Hypothesis: A p-value greater than 0.05 suggests the means are not statistically different from one another.||||||0.84|||||||t-test, 2 sided|||||||0.84
71734161|NCT00975143|142983601|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference \< 4.|LS Mean Difference|0.1382||||0.5077|TWO_SIDED|95.0|-0.2712|0.5475||P values are from analysis of covariance (ANCOVA) controlling for Baseline total nodular lesion count, gender and analysis site.|ANCOVA|The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was calculated using the ANCOVA model.||Change from Baseline was calculated as the post-Baseline value minus the Baseline value||0.5475|-0.2712|0.5077
71734162|NCT00975143|142983602|NON_INFERIORITY_OR_EQUIVALENCE|If the two co-primary endpoints were significant, a 95% 2 sided CI on the difference between treatments (CIP-Isotretinoin minus Isotretinoin) was calculated.|Proportion difference|-3.48|||>|0.05|TWO_SIDED|95.0|-8.4|1.4|||Normal approximation|95% CI on difference in proportions (CIP-Isotretinoin minus Isotretinoin) was estimated using normal approximation.||The analysis of the secondary efficacy endpoint was based on observed cases only, with no imputation for missing values.||1.4|-8.4|>0.05
71734163|NCT00975143|142983603|NON_INFERIORITY_OR_EQUIVALENCE|Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference \> -10.|Proportion difference|-2.1|||>|0.05|TWO_SIDED|95.0|-7.94|3.74|||Normal approximation|||||3.74|-7.94|>0.05
71734164|NCT00545103|142983605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.778||95.0|||||Cochran-Mantel-Haenszel|||||||0.778
71734165|NCT00545103|142983605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159||95.0|||||Cochran-Mantel-Haenszel|||||||0.159
71734166|NCT00545103|142983605|SUPERIORITY_OR_OTHER_LEGACY|||||||0.368||95.0|||||Cochran-Mantel-Haenszel|||||||0.368
71734167|NCT00545103|142983606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0|||||Cochran-Mantel-Haenszel|||||||0.685
71734168|NCT00545103|142983606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198||95.0|||||Cochran-Mantel-Haenszel|||||||0.198
71734169|NCT00545103|142983606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441||95.0|||||Cochran-Mantel-Haenszel|||||||0.441
71734170|NCT00082381|142983615|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and insulin glargine is less than 0.4%.)|Mean Difference (Final Values)|0.05||||0.4602||95.0|-0.09|0.2|||ANCOVA|||||0.20|-0.09|0.4602
71734171|NCT00082381|142983616|SUPERIORITY_OR_OTHER|||||||0.7839||95.0|||||Fisher Exact|||||||0.7839
71734172|NCT00082381|142983617|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71734173|NCT00082381|142983618|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71734174|NCT00082381|142983620|SUPERIORITY_OR_OTHER|||||||0.3002||95.0|||||Fisher Exact|||||||0.3002
71773015|NCT00450112|143045732|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..||||<0.0001
71734175|NCT00082381|142983621|SUPERIORITY_OR_OTHER|||||||0.3385||95.0|||||ANCOVA|||||||0.3385
71734176|NCT00884832|142983661|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.||||<0.001
71734177|NCT00884832|142983662|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
71734178|NCT00884832|142983662|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||ANCOVA|||drug\*group interactions||||0.047
71734179|NCT00884832|142983664|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||ANCOVA|||||||0.082
71734180|NCT02096263|142983665|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.1|||||TWO_SIDED|95.0|0.92|1.31|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.||1.31|0.92|
71734181|NCT02096263|142983665|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|1.14|||||TWO_SIDED|95.0|0.97|1.35|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.||1.35|0.97|
71734182|NCT02096263|142983665|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio \[Pediarix Group divided by Infanrix hexa Group\] is ≤ 1.5.|Adjusted GMC ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.||0.99|0.63|
71734183|NCT03322423|142983708|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.058|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.08|-0.035|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.035|-0.080|
71734184|NCT03322423|142983708|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.076|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.099|-0.054|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||-0.054|-0.099|
71734185|NCT03322423|142983709|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
71734186|NCT03322423|142983709|SUPERIORITY|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|STANDARD_ERROR_OF_MEAN|0.0147|||TWO_SIDED|95.0|0.112|0.17|||Linear mixed model analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||0.170|0.112|
71734187|NCT03322423|142983710|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|45.5|STANDARD_ERROR_OF_MEAN|2.19|||TWO_SIDED|95.0|41.2|49.9|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||49.9|41.2|
71734188|NCT03322423|142983710|SUPERIORITY|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|46.4|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|42.1|50.8|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||50.8|42.1|
71734189|NCT02337725|142983711|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.39|||<|0.0001|TWO_SIDED|95.0|-8.53|-4.25|||ANCOVA||Estimated Value was reported for the least squares mean difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-4.250|-8.530|<0.0001
71734190|NCT02453555|142983720|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.36|-0.91|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 24 in Empagliflozin 10 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 24 in Linagliptin 5 mg + Placebo 10 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.91|-1.36|<0.0001
71773016|NCT00450112|143045732|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
71773017|NCT00450112|143045734|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
71773018|NCT00450112|143045734|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
71734191|NCT02453555|142983722|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.99|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in All Empagliflozin group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.99|-1.45|<0.0001
71761303|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|4.3|9.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.||9.6|4.3|<0.0001
71761304|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0229|TWO_SIDED|95.0|0.4|5.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.||5.7|0.4|0.0229
71661235|NCT04420273|142836094|OTHER||||||<|0.001|||||||McNemar|McNemar's chi-square with continuity correction||3-months||||<0.001
71661236|NCT04420273|142836095|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71761305|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|1.1||0.0004|TWO_SIDED|95.0|1.7|6.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.||6.0|1.7|0.0004
71761306|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.2||0.0003|TWO_SIDED|95.0|2.0|6.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.||6.9|2.0|0.0003
71761307|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.2||0.0923|TWO_SIDED|95.0|-0.3|4.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.||4.5|-0.3|0.0923
71761308|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.0||0.018|TWO_SIDED|95.0|0.4|4.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.||4.4|0.4|0.0180
71761309|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|1.3|5.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.||5.1|1.3|0.0011
71761310|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.0||0.2208|TWO_SIDED|95.0|-0.7|3.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.||3.1|-0.7|0.2208
71761311|NCT00611026|143024054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0117|TWO_SIDED|95.0|0.4|3.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.||3.5|0.4|0.0117
71761312|NCT05019521|143024056|SUPERIORITY||Least square (LS) mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0413||0.9205|TWO_SIDED|90.0|-0.01|0.126|||Mixed Models Analysis|||||0.126|-0.010|0.9205
71761313|NCT05019521|143024056|SUPERIORITY||LS mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0425||0.9205|TWO_SIDED|90.0|-0.086|0.055|||Mixed Models Analysis|||||0.055|-0.086|0.9205
71761314|NCT05019521|143024056|SUPERIORITY||LS mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.0422||0.9205|TWO_SIDED|90.0|-0.033|0.106|||Mixed Models Analysis|||||0.106|-0.033|0.9205
71761315|NCT04674761|143024117|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.277||0.0012|TWO_SIDED|95.0|-1.44|-0.33|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline score as a covariate, and baseline age stratification, baseline direct bilirubin, treatment group, time (in months), and treatment-by-time interaction as fixed effects. One-sided p-value was reported.||-0.33|-1.44|0.0012
71761316|NCT04674761|143024118|SUPERIORITY||LS mean difference|-112.74|STANDARD_ERROR_OF_MEAN|32.864||0.0006|TWO_SIDED|95.0|-178.78|-46.69|||Mixed Models Analysis|||The analysis is based on a mixed model for repeated measures (MMRM) using a restricted maximum likelihood (REML) with baseline serum bile acid (sBA) concentration data as a covariate, and baseline age stratification, treatment group, visits (Weeks 4, 8, 12, 16, 20, 24), and treatment-by-visit interaction as fixed effects. The comparison of treatment difference in change from baseline to the average of Week 20 and Week 24 is estimated and tested using contrast. One-sided p-value was reported.||-46.69|-178.78|0.0006
71761317|NCT02039843|143024120|SUPERIORITY|||||||0.052||||||Two-sided a priori alpha level was 0.05.|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in WHO-DAS score adjusted for gender, site, baseline score, time \& timeXgroup interaction||||||0.052
71734192|NCT02453555|142983723|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in Linagliptin 5 mg + Placebo 25 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.96|-1.45|<0.0001
71734193|NCT02453555|142983724|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.34|-0.84|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease \[MDRD\] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.||-0.84|-1.34|<0.0001
71734194|NCT00500760|142983725|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.07|||||TWO_SIDED|95.0|-0.23|0.09|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|||0.09|-0.23|
71734195|NCT00500760|142983726|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 6 months||0.12|-0.18|
71734196|NCT00500760|142983726|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimate|-0.03|||||TWO_SIDED|95.0|-1.09|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 12 months||0.12|-1.09|
71734197|NCT00500760|142983727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.328||||0.3106|TWO_SIDED|95.0|0.767|2.299|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||2.299|0.767|0.3106
71734198|NCT00500760|142983728|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6069|TWO_SIDED|95.0|0.675|1.961|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||1.961|0.675|0.6069
71734199|NCT00500760|142983729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.628||||0.1223|TWO_SIDED|95.0|0.877|3.019|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.|||3.019|0.877|0.1223
71734200|NCT00500760|142983730|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.1737|TWO_SIDED|95.0|0.217|1.262|||Regression, Logistic||The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||1.262|0.217|0.1737
71734201|NCT00500760|142983730|SUPERIORITY_OR_OTHER||Difference in rate|-10.99|||||TWO_SIDED|95.0|-24.56|4.14|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||4.14|-24.56|
71734202|NCT00500760|142983731|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||1|TWO_SIDED|95.0|0.448|2.712|||Regression, Logistic||The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.|||2.712|0.448|1.0000
71734203|NCT00500760|142983731|SUPERIORITY_OR_OTHER||Difference in rate|1.33|||||TWO_SIDED|95.0|-13.23|14.71|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.|||14.71|-13.23|
71734204|NCT00129961|142983734|SUPERIORITY_OR_OTHER|||||||0.022||||||Poisson regression was used to model NMSC counts using the years in study as an offset. The generalized estimated equations (GEE) approach was used to estimate parameters and compare treatment differences.|Poisson regression|Adjusted by baseline strata; Poisson model = strata + treatment.||||||0.022
71734205|NCT00129961|142983735|SUPERIORITY_OR_OTHER|||||||0.047|||||||Regression, Cox|Stratified by baseline lesions||||||0.047
71734206|NCT00129961|142983736|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.015
71734207|NCT00129961|142983737|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||Chi-squared|||||||0.799
71734208|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Well differentiated||||0.014
71734209|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Moderately differentiated||||0.491
71734210|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.905||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Poorly differentiated||||0.905
71734211|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive||||0.018
71734212|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC In Situ||||0.012
71734213|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.463||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive with Perineural Invasion||||0.463
71734214|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive without Perineural Invasion||||0.004
71734215|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Superficial||||0.094
71734216|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Nodular||||0.720
71734217|NCT00129961|142983738|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Infiltrative||||0.227
71734218|NCT00129961|142983739|SUPERIORITY_OR_OTHER|||||||0.748||95.0|||||Poisson regression|||||||0.748
71734219|NCT00129961|142983740|SUPERIORITY_OR_OTHER|||||||0.425||95.0|||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||||||0.425
71773019|NCT00450112|143045735|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.||||<0.0001
71734220|NCT00129961|142983743|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
71734221|NCT00129961|142983744|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||ANCOVA|||||||0.672
71734222|NCT00129961|142983745|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
71734223|NCT00129961|142983746|SUPERIORITY_OR_OTHER|||||||0.588||95.0|||||Fisher Exact|||||||0.588
71734224|NCT00129961|142983747|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Fisher Exact|||||||0.999
71734225|NCT00129961|142983748|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.030
71734226|NCT03178669|142983749|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1806|TWO_SIDED|80.0|0.75|5.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||5.47|0.75|0.1806
71734227|NCT03178669|142983749|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6649|TWO_SIDED|80.0|0.2|2.24||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.24|0.20|0.6649
71773020|NCT00450112|143045735|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.||||<0.0001
71773021|NCT00417482|143045740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.94||||0.02|TWO_SIDED|95.0|1.09|3.45|||Stratified Cox analysis|||The primary hypothesis of a difference in survival functions between the initial Phase B placebo (Arm 3) and risperidone continuation (Arms 1+2) conditions was tested in the primary analysis using the stratified Cox analysis. For descriptive purposes, the overall rate of relapse was assessed as the number of follow-up or for secondary interpretative support, as a simple proportion of patients entering a 16-week period.||3.45|1.09|0.02
71773022|NCT00417482|143045741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.88||||0.02|TWO_SIDED|95.0|1.08|21.98|||stratified cox analyses|||Similar analyses were used to test the secondary hypothesis in the relapse risk in weeks 17 to 32 of Phase B between the patients who continued to receive risperidone (Arm 1) \& the patients who discontinued risperidone at week 16 \& were switched to placebo (Arm 2). Patients who died \& those in whom a relapse was considered to be imminent before they were dropped out in Phase B were classified as having relapse.||21.98|1.08|0.02
71773023|NCT00417482|143045742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.36||0.08|TWO_SIDED|95.0|-0.08|1.35|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.||1.35|-0.08|0.08
71773024|NCT00417482|143045743|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.49||0.94||95.0|-1.01|0.93|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.||0.93|-1.01|0.94
71831958|NCT03950622|143168518|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.98|||||TWO_SIDED|95.0|8.0|10.07||||||Serotype 33F (Unique to V114)||10.07|8.00|
71831959|NCT03074331|143168543|SUPERIORITY|||||||0.009|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.||||0.009
71831960|NCT01796236|143168553|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||||||0.12
71831961|NCT01796236|143168554|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||"Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index \>=2. Any Overgrowth \>=2. Pain (scar/neuropathic) \>=3. Any numbness \>=2.~Each event is counted only once"||||0.45
71831962|NCT01796236|143168555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney U test|||||||<0.0001
71831963|NCT01796236|143168556|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||Day 10||||0.020
71831964|NCT01796236|143168556|SUPERIORITY_OR_OTHER|||||||0.4|||||||Fisher Exact|||Week 3||||0.4
71831965|NCT01796236|143168556|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 6||||1.00
71831966|NCT01796236|143168556|SUPERIORITY_OR_OTHER|||||||0.97|||||||Fisher Exact|||Week 12||||0.97
71661237|NCT04420273|142836096|OTHER||||||<|0.1|||||||Chi-squared|||||||< 0.1
71734228|NCT03178669|142983749|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0247|TWO_SIDED|80.0|1.53|9.47||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||9.47|1.53|0.0247
71734229|NCT03178669|142983749|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3279|TWO_SIDED|80.0|0.52|3.88||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.88|0.52|0.3279
71734230|NCT03178669|142983750|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2115|TWO_SIDED|80.0|0.69|4.99||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||4.99|0.69|0.2115
71734231|NCT03178669|142983750|SUPERIORITY||Odds Ratio (OR)|0.3||||0.8498|TWO_SIDED|80.0|0.06|1.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.34|0.06|0.8498
71831967|NCT01796236|143168556|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Week 24||||1.00
71831968|NCT01796236|143168557|SUPERIORITY_OR_OTHER|||||||0.4|||||||Mantel Haenszel|||Maximum of Holgers at 12 Months||||0.40
71831969|NCT01796236|143168557|SUPERIORITY_OR_OTHER|||||||0.14|||||||Mantel Haenszel|||Maximum of Holgers at 36 Months||||0.14
71831970|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mantel Haenszel|||Holgers Index Day 10||||0.38
71831971|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mantel Haenszel|||Holgers Index Week 3||||0.17
71831972|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Week 6||||0.37
71831973|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Week 12||||0.73
71831974|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.47|||||||Mantel Haenszel|||Holgers Index Week 24||||0.47
71831975|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mantel Haenszel|||Holgers Index Month 12||||0.73
71831976|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mantel Haenszel|||Holgers Index Month 24||||0.37
71831977|NCT01796236|143168558|SUPERIORITY_OR_OTHER|||||||0.75|||||||Mantel Haenszel|||Holgers Index Month 36||||0.75
71773025|NCT00417482|143045744|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.48||0.26|TWO_SIDED|95.0|-1.5|0.41|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.||0.41|-1.50|0.26
71773026|NCT00417482|143045745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.13|TWO_SIDED|95.0|-0.5|0.07|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.||0.07|-0.50|0.13
71773027|NCT00417482|143045746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.43||0.149|TWO_SIDED|95.0|-1.47|0.23|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.||0.23|-1.47|0.149
71831978|NCT01796236|143168559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 12 months||||<0.0001
71831979|NCT01796236|143168559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 36 months||||<0.0001
71773028|NCT00417482|143045747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.69||0.81|TWO_SIDED|95.0|-3.77|2.95|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.||2.95|-3.77|0.81
71773029|NCT05402020|143045748|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first moderate or severe COPD exacerbations) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.15|0.87|
71773030|NCT05402020|143045749|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.53|0.85|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (triple therapy escalation) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||0.85|0.53|
71773031|NCT05402020|143045750|OTHER||Incidence difference|-37.9|||||TWO_SIDED|95.0|-60.1|-15.8|||||Incidence difference calculated as \[incidence rate of Tio/Olo\]-\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||-15.8|-60.1|
71773032|NCT05402020|143045750|OTHER||Incidence Rate Ratio|0.66|||||TWO_SIDED|95.0|0.51|0.85|||||Ratio calculated as \[incidence rate of Tio/Olo\]/\[incidence rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||0.85|0.51|
71773033|NCT05402020|143045751|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.36|1.93|||||Ratio calculated as \[Tio/Olo\]/\[ICS/LABA\]|Univariate proportional hazards regression was used to compare the time to event (first hospitalization for community-acquired pneumonia after initiation of study drug) between the two treatment groups. In the event that there were baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) were included in a multiple regression model in addition to the exposure status (Tio/Olo or ICS/LABA).||1.93|0.36|
71831980|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Day 10, Neuropathic pain||||0.74
71831981|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Day 10, Scar pain||||0.36
71831982|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Week 3, Neuropathic pain||||0.030
71831983|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Week 3, Scar pain||||0.92
71831984|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Week 6, Neuropathic pain||||0.15
71831985|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Week 6, Scar pain||||0.38
71831986|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Week 12, Neuropathic pain||||0.015
71831987|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12, Scar pain||||0.72
71831988|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Week 24, Neuropathic pain||||0.44
71831989|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24, Scar pain||||0.43
71831990|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12, Neuropathic pain||||0.21
71831991|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12, Scar pain||||0.97
71831992|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36, Neuropathic pain||||0.19
71661238|NCT04420273|142836097|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71831993|NCT01796236|143168560|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Month 36, Scar pain||||0.77
71831994|NCT01796236|143168561|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain||||0.076
71831995|NCT01796236|143168561|SUPERIORITY_OR_OTHER|||||||0.49|||||||Mantel Haenszel|||Scar Categorical Max Pain||||0.49
71831996|NCT01796236|143168562|SUPERIORITY_OR_OTHER|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain 36 months||||0.076
71831997|NCT01796236|143168562|SUPERIORITY_OR_OTHER|||||||0.71|||||||Mantel Haenszel|||Scar Categorical Max Pain 36 months||||0.71
71831998|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|||Day 10: Neuropathic pain||||0.52
71831999|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Day 10: Scar pain||||0.44
71734232|NCT03178669|142983750|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0977|TWO_SIDED|80.0|1.01|6.62||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||6.62|1.01|0.0977
71734233|NCT03178669|142983750|SUPERIORITY||Odds Ratio (OR)|1.0||||0.522|TWO_SIDED|80.0|0.32|2.84||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.84|0.32|0.5220
71734234|NCT03178669|142983751|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2335|TWO_SIDED|80.0|0.74|2.94||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.94|0.74|0.2335
71734235|NCT03178669|142983751|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2511|TWO_SIDED|80.0|0.73|2.69||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.69|0.73|0.2511
71734236|NCT03178669|142983751|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1162|TWO_SIDED|80.0|0.96|3.52||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||3.52|0.96|0.1162
71734237|NCT03178669|142983751|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3467|TWO_SIDED|80.0|0.63|2.4||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.40|0.63|0.3467
71734238|NCT03178669|142983752|SUPERIORITY||Odds Ratio (OR)|0.9||||0.6326|TWO_SIDED|80.0|0.5|1.5||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.50|0.50|0.6326
71734239|NCT03178669|142983752|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7127|TWO_SIDED|80.0|0.45|1.37||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.37|0.45|0.7127
71734240|NCT03178669|142983752|SUPERIORITY||Odds Ratio (OR)|1.3||||0.2658|TWO_SIDED|80.0|0.75|2.34||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.34|0.75|0.2658
71734241|NCT03178669|142983752|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8301|TWO_SIDED|80.0|0.36|1.16||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.16|0.36|0.8301
71734242|NCT03178669|142983753|SUPERIORITY||Odds Ratio (OR)|0.6||||0.7994|TWO_SIDED|80.0|0.32|1.27||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.27|0.32|0.7994
71734243|NCT03178669|142983753|SUPERIORITY||Odds Ratio (OR)|0.3||||0.9665|TWO_SIDED|80.0|0.16|0.72||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.72|0.16|0.9665
71734244|NCT03178669|142983753|SUPERIORITY||Odds Ratio (OR)|1.5||||0.2049|TWO_SIDED|80.0|0.8|2.82||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||2.82|0.80|0.2049
71734245|NCT03178669|142983753|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6504|TWO_SIDED|80.0|0.42|1.6||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.60|0.42|0.6504
71734246|NCT03178669|142983754|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9207|TWO_SIDED|80.0|0.18|0.93||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.93|0.18|0.9207
71734247|NCT03178669|142983754|SUPERIORITY||Odds Ratio (OR)|0.4||||0.9228|TWO_SIDED|80.0|0.19|0.92||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||0.92|0.19|0.9228
71832000|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.14|||||||Cochran-Mantel-Haenszel|||Week 3: Neuropathic pain||||0.14
71832001|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.59|||||||Cochran-Mantel-Haenszel|||Week 3: Scar pain||||0.59
71734248|NCT03178669|142983754|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6636|TWO_SIDED|80.0|0.39|1.61||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.61|0.39|0.6636
71734249|NCT03178669|142983754|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7449|TWO_SIDED|80.0|0.34|1.41||one-sided and adjusted for stratification factors, p values of less than 0.10 were regarded as statistically significant.|Cochran-Mantel-Haenszel|||||1.41|0.34|0.7449
71734250|NCT01600092|142983755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G1||1.07|0.79|
71734251|NCT01600092|142983755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G2||1.33|0.99|
71734252|NCT01600092|142983755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|3.2|||||TWO_SIDED|95.0|2.75|3.74|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G3||3.74|2.75|
71734253|NCT01600092|142983755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G4||1.20|0.94|
71734254|NCT01600092|142983755|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \>0.67|GMT Ratio (Experimental/Existing)|1.16|||||TWO_SIDED|95.0|1.0|1.35|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype P1A\[8\]||1.35|1.00|
71832002|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.17|||||||Cochran-Mantel-Haenszel|||Week 6: Neuropathic pain||||0.17
71832003|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|||Week 6: Scar pain||||0.44
71734255|NCT00079677|142983760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0003||95.0|1.67|5.46||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05||5.46|1.67|0.0003
71734256|NCT00079677|142983761|SUPERIORITY_OR_OTHER|||||||0.0069||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|Cochran-Mantel-Haenszel|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0069
71659652|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
71734257|NCT02641067|142983793|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|90.0|1.0|2.04||||||||2.04|1.00|
71734258|NCT02641067|142983794|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|0.99|1.92||||||||1.92|0.99|
71734259|NCT02641067|142983795|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.61|1.15||||||||1.15|0.61|
71734260|NCT02925728|142983803|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71832004|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.0087|||||||Cochran-Mantel-Haenszel|||Week 12: Neuropathic pain||||0.0087
71832005|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.84|||||||Cochran-Mantel-Haenszel|||Week 12: Scar pain||||0.84
71832006|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.43|||||||Cochran-Mantel-Haenszel|||Week 24: Neuropathic pain||||0.43
71832007|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.33|||||||Cochran-Mantel-Haenszel|||Week 24: Scar pain||||0.33
71832008|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.21|||||||Cochran-Mantel-Haenszel|||Month 12 Neuropathic pain||||0.21
71832009|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Month 12 Scar pain||||0.82
71832010|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|||Month 36 Neuropathic pain||||0.19
71832011|NCT01796236|143168563|SUPERIORITY_OR_OTHER|||||||0.77|||||||Cochran-Mantel-Haenszel|||Month 36 Scar pain||||0.77
71734261|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.95|||||TWO_SIDED|95.0|21.76|41.25|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||41.25|21.76|
71734262|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.86|||||TWO_SIDED|95.0|21.66|41.17|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||41.17|21.66|
71734263|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|30.91|||||TWO_SIDED|95.0|21.89|41.12|||Miettinen & Nurminen score method|||Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||41.12|21.89|
71734264|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Difference in percentages|0.09|||||TWO_SIDED|95.0|-3.15|3.36|||Miettinen & Nurminen score method|||Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||3.36|-3.15|
71734265|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.5|||||TWO_SIDED|95.0|28.54|48.9|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||48.90|28.54|
71734266|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|39.08|||||TWO_SIDED|95.0|29.16|49.46|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||49.46|29.16|
71761318|NCT02039843|143024121|SUPERIORITY|||||||0.421||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.421
71761319|NCT02039843|143024122|SUPERIORITY|||||||0.606||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in MCS score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.606
71761320|NCT02039843|143024123|SUPERIORITY|||||||0.21||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PSQI score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.210
71761321|NCT02039843|143024124|SUPERIORITY|||||||0.036||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PCL-5 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.036
71761322|NCT02039843|143024125|SUPERIORITY|||||||0.079||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in PHQ-9 score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.079
71761323|NCT02039843|143024126|SUPERIORITY|||||||0.155||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Linear mixed repeated measures analysis on group difference in DAR score adjusted for gender, site, baseline score, time, and timeXgroup||||||0.155
71761324|NCT02039843|143024127|SUPERIORITY|||||||0.157||||||2-sided a priori alpha level was 0.05|Mixed Models Analysis|Generalized linear mixed repeated measures analysis on group difference in SBI adjusted for gender, site, baseline SBI, time, and timeXgroup||||||0.157
71761325|NCT02039843|143024128|SUPERIORITY|||||||0.43||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.430
71761326|NCT02039843|143024129|SUPERIORITY|||||||0.358||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.358
71761327|NCT02039843|143024130|SUPERIORITY|||||||0.39||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.39
71761328|NCT02039843|143024140|SUPERIORITY|||||||0.383||||||p-value from random effects regression controlling for month and baseline outcome|Regression, Linear|||||||0.383
71761329|NCT02039843|143024141|SUPERIORITY|||||||0.932|||||||Regression, Linear|||||||0.932
71734267|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|38.79|||||TWO_SIDED|95.0|29.03|49.06|||Miettinen & Nurminen score method|||Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||49.06|29.03|
71734268|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|-0.59|||||TWO_SIDED|95.0|-4.12|2.92|||Miettinen & Nurminen score method|||Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||2.92|-4.12|
71773034|NCT05402020|143045752|OTHER||Annualized rate ratio|0.92|||||TWO_SIDED|95.0|0.81|1.03|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.03|0.81|
71773035|NCT05402020|143045753|OTHER||Annualized rate ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Annualized rate ratio calculated as \[annualized rate of Tio/Olo\]/\[annualized rate of ICS/LABA\].|The rate ratio of Tio+Olo - exposed group relative to LABA/ICS group, along with 95% CIs were derived using a univariate negative binomial model. In the event that there are baseline covariates with unequal distribution between the treatment groups, defined as absolute standardized difference larger than 0.1, the covariate(s) will be included in a multiple regression model in addition to the exposure status (Tio/Olo or LABA/ICS).||1.18|0.87|
71773036|NCT06400979|143045754|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
71773037|NCT06400979|143045755|SUPERIORITY|To assess the reduction of nausea following aromatherapy, pre- and post- aromatherapy scores were compared using paired t-tests||||||0.13|||||||ANCOVA|||||||0.13
71773038|NCT06400979|143045756|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71773039|NCT06400979|143045757|OTHER|Perceived effectiveness of aromatherapy for patient satisfaction were compared with respect to post-aromatherapy scores and pre-post changes in scores using two-sample t-tests||||||0.02|TWO_SIDED|73.4|||||t-test, 2 sided|||||||0.02
71773040|NCT06400979|143045758|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
71661239|NCT04420273|142836098|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71773041|NCT06400979|143045759|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
71773042|NCT03739840|143045760|SUPERIORITY||Percent reduction|-5.6|||=|0.687|TWO_SIDED|95.0|-38.1|19.2||Adjusted p-values are from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||19.2|-38.1|=0.687
71773043|NCT03739840|143045760|SUPERIORITY||Percent reduction|6.5|||=|0.687|TWO_SIDED|95.0|-22.7|28.7||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.7|-22.7|=0.687
71773044|NCT03739840|143045760|SUPERIORITY||Percent reduction|6.3|||=|0.687|TWO_SIDED|95.0|-22.9|28.6||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||28.6|-22.9|=0.687
71773045|NCT03739840|143045764|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.803|TWO_SIDED|95.0|0.39|3.38||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.38|0.39|=0.803
71773046|NCT03739840|143045764|SUPERIORITY||Odds Ratio (OR)|0.84|||=|0.772|TWO_SIDED|95.0|0.27|2.65||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||2.65|0.27|=0.772
71773047|NCT03739840|143045764|SUPERIORITY||Odds Ratio (OR)|1.01|||=|0.989|TWO_SIDED|95.0|0.33|3.08||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.08|0.33|=0.989
71773048|NCT03739840|143045765|SUPERIORITY||Odds Ratio (OR)|1.4|||=|0.425|TWO_SIDED|95.0|0.61|3.18||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate.||3.18|0.61|=0.425
71773049|NCT03739840|143045765|SUPERIORITY||Odds Ratio (OR)|1.23|||=|0.625|TWO_SIDED|95.0|0.53|2.85||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||2.85|0.53|=0.625
71832012|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mantel Haenszel|||Day 10 Soft tissue thickening/overgrowth||||0.12
71832013|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mantel Haenszel|||Week 3 Soft tissue thickening/overgrowth||||0.016
71832014|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mantel Haenszel|||Week 6 Soft tissue thickening/overgrowth||||0.84
71661240|NCT04420273|142836099|OTHER|||||||0.459|||||||Chi-squared|||||||0.459
71661241|NCT04420273|142836099|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71734269|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|59.98|||||TWO_SIDED|95.0|49.49|69.32|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||69.32|49.49|
71734270|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|57.37|||||TWO_SIDED|95.0|46.71|66.88|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||66.88|46.71|
71734271|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|58.69|||||TWO_SIDED|95.0|48.32|67.94|||Miettinen & Nurminen score method|||Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||67.94|48.32|
71734272|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.61|||||TWO_SIDED|95.0|-1.17|6.62|||Miettinen & Nurminen score method|||Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.62|-1.17|
71734273|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|45.25|||||TWO_SIDED|95.0|35.11|55.47|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)||55.47|35.11|
71773050|NCT03739840|143045765|SUPERIORITY||Odds Ratio (OR)|1.9|||=|0.125|TWO_SIDED|95.0|0.84|4.34||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), Region (Europe, non-Europe), Baseline SV2A use (Yes, No) and log-transformed Baseline seizure frequency as a continuous covariate||4.34|0.84|=0.125
71773051|NCT03739840|143045766|SUPERIORITY||Median Difference (Final Values)|3.25|||=|0.737|TWO_SIDED|95.0|-17.08|20.36||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||20.36|-17.08|=0.737
71773052|NCT03739840|143045766|SUPERIORITY||Median Difference (Net)|6.17|||=|0.458|TWO_SIDED|95.0|-10.0|21.91||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||21.91|-10.00|=0.458
71773053|NCT03739840|143045766|SUPERIORITY||Median Difference (Net)|9.31|||=|0.341|TWO_SIDED|95.0|-10.92|28.21||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value are based on the Wilcoxon-Mann-Whitney test. Hodges Lehmann nonparametric effect estimates and corresponding two-sided 95% asymptotic confidence intervals are provided for the effect difference between each PSL dose and placebo.||28.21|-10.92|=0.341
71773054|NCT01058265|143045768|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in PCS between two groups.||||0.487
71773055|NCT01058265|143045769|SUPERIORITY_OR_OTHER|||||||0.817||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in MCS between two groups.||||0.817
71773056|NCT02343081|143045776|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the ratio of the mean for Cmax for Temozolomide reference and test to fall within the 80-125% confidence range.|Cmax|94.37|||<|0.05|TWO_SIDED|90.0|82.69|107.69|||ANOVA|Primary parameters were analyzed using ANOVA. A linear, mixed model for crossover designs (two-period, two-sequence, two-treatment) was used.|Cmax Test/Reference Ratio|Bioequivalence assessment was made for the 90% CI for the ratio of log transformed pharmacokinetic parameters μT / μR and with the two one-sided Schuirmann T-test procedure under the null hypothesis||107.69|82.69|<0.05
71773057|NCT02343081|143045780|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-t for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-t|100.99|||<|0.05|TWO_SIDED|90.0|97.81|104.28|||ANOVA||AUC0-t Test/Reference Ratio|||104.28|97.81|<0.05
71773058|NCT02343081|143045781|NON_INFERIORITY_OR_EQUIVALENCE|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-inf for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-inf|101.53|||<|0.05|TWO_SIDED|90.0|98.6|104.54|||ANOVA||AUC0-inf Test/Reference Ratio|||104.54|98.60|<0.05
71775092|NCT01920555|143050513|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.53|TWO_SIDED|95.0|-9.03|4.72||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||4.72|-9.03|0.53
71661242|NCT04420273|142836100|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71734274|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|42.67|||||TWO_SIDED|95.0|32.34|53.04|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)||53.04|32.34|
71734275|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|43.98|||||TWO_SIDED|95.0|33.92|54.14|||Miettinen & Nurminen score method|||Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||54.14|33.92|
71734276|NCT02986854|142983828|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Difference in percentages|2.58|||||TWO_SIDED|95.0|-0.86|6.3|||Miettinen & Nurminen score method|||Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)||6.3|-0.86|
71773059|NCT02675231|143045825|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.0506|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.0506
71773060|NCT02675231|143045825|SUPERIORITY|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.7695|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) \>3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.||||0.7695
71659653|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
71773061|NCT02675231|143045826|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.241|TWO_SIDED|95.0|0.36|1.3|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.30|0.36|0.241
71773062|NCT02675231|143045826|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.313|TWO_SIDED|95.0|0.38|1.36|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.36|0.38|0.313
71773063|NCT02675231|143045827|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104|TWO_SIDED|95.0|0.42|1.08|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.08|0.42|0.104
71773064|NCT02675231|143045827|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.12|TWO_SIDED|95.0|0.43|1.1|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.10|0.43|0.120
71773065|NCT02675231|143045828|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.049|TWO_SIDED|95.0|0.42|1.0|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.00|0.42|0.049
71773066|NCT02675231|143045828|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.153|TWO_SIDED|95.0|0.48|1.12|||Log Rank||Stratified by the number of previous regimens (excluding single-agent endocrine therapy) for advanced breast cancer and the status of disease (measurable vs. non-measurable).|||1.12|0.48|0.153
71773067|NCT02675231|143045833|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.232|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.232
71773068|NCT02675231|143045834|SUPERIORITY||Least Square (LS) Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|2.4||0.689|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Global health status||||0.689
71773069|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.3||0.141|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scales: Physical functioning||||0.141
71773070|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.3||0.095|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Role functioning||||0.095
71773071|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.5||0.591|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Emotional functioning||||0.591
71773072|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|2.1||0.935|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Cognitive functioning||||0.935
71773073|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.7||0.578|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Functional scale: Social functioning||||0.578
71773074|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.8||0.308|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Fatigue||||0.308
71773075|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|2.0||0.043|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Nausea and vomiting||||0.043
71832015|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.53|||||||Mantel Haenszel|||Week 12 Soft tissue thickening/overgrowth||||0.53
71832016|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mantel Haenszel|||Week 24 Soft tissue thickening/overgrowth||||0.18
71832017|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mantel Haenszel|||Month 12 Soft tissue thickening/overgrowth||||0.63
71661243|NCT02994940|142836112|SUPERIORITY||Hodges Lehman estimator|21.3||||0.127|TWO_SIDED|95.0|-2.5|44.2|||Wilcoxon (Mann-Whitney)|||||44.2|-2.5|0.127
71661244|NCT02994940|142836113|SUPERIORITY|||||||0.851|||||||Chi-squared|||||||0.851
71773076|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|3.0||0.026|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Pain||||0.026
71773077|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.8||0.276|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Dyspnoea||||0.276
71659654|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
71659655|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71659656|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
71659657|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
71659658|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001|TWO_SIDED|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
71659659|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
71773078|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.1||0.041|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Insomnia||||0.041
71773079|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|3.4||0.262|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Appetite loss||||0.262
71773080|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.7||0.285|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Constipation||||0.285
71773081|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Diarrhoea||||< 0.001
71773082|NCT02675231|143045834|SUPERIORITY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|3.0||0.18|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||Symptom scale: Financial difficulties||||0.180
71773083|NCT02675231|143045835|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.033|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.033
71773084|NCT02675231|143045835|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.275|TWO_SIDED|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment\*Visit + Baseline.|MMRM Model|||||||0.275
71773085|NCT02675231|143045836|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.02||0.546|TWO_SIDED||||||MMRM Model|||||||0.546
71773086|NCT02675231|143045836|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|2.1||0.62|TWO_SIDED||||||MMRM Model|||||||0.620
71773087|NCT05014490|143045838|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|102.15|||||TWO_SIDED|90.0|94.54|110.37|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||110.37|94.54|
71832018|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mantel Haenszel|||Month 24 Soft tissue thickening/overgrowth||||0.81
71832019|NCT01796236|143168564|SUPERIORITY_OR_OTHER|||||||1|||||||Mantel Haenszel|||Month 36 Soft tissue thickening/overgrowth||||1.00
71832020|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Day 10||||0.0009
71832021|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 3||||0.0080
71832022|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 6||||0.46
71832023|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 12||||0.45
71832024|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 24||||0.18
71832025|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 12||||0.017
71832026|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 24||||0.15
71734277|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.16|||||TWO_SIDED|95.0|1.23|13.41|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||13.41|1.23|
71734278|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|10.59|||||TWO_SIDED|95.0|3.54|16.14|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||16.14|3.54|
71734279|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|9.36|||||TWO_SIDED|95.0|2.72|13.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)||13.58|2.72|
71734280|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method.|Between group differences in percentage|-2.44|||||TWO_SIDED|95.0|-8.17|3.24|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.24|-8.17|
71832027|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 36||||0.32
71832028|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.74|||||||Sign test|||Change in Visible Test Abutment - Week 3 change from day 10||||0.74
71832029|NCT01796236|143168565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Test Abutment - Week 6 change from day 10||||<0.0001
71832030|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.041|||||||Sign test|||Change in Visible Test Abutment - Week 12 change from day 10||||0.041
71832031|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Sign test|||Change in Visible Test Abutment - Week 24 change from day 10||||0.0065
71832032|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Sign test|||Change in Visible Test Abutment - Month 12 change from day 10||||0.0003
71832033|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.028|||||||Sign test|||Change in Visible Test Abutment - Month 24 change from day 10||||0.028
71832034|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.037|||||||Sign test|||Change in Visible Test Abutment - Month 36 change from day 10||||0.037
71832035|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.072|||||||Sign test|||Change in Visible Control Abutment - Week 3 change from day 10||||0.072
71832036|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.034|||||||Sign test|||Change in Visible Control Abutment - Week 6 change from day 10||||0.034
71832037|NCT01796236|143168565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Visible Control Abutment - Week 12 change from day 10||||<0.0001
71832038|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.01|||||||Sign test|||Change in Visible Control Abutment - Week 24 change from day 10||||0.010
71832039|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.0086|||||||Sign test|||Change in Visible Control Abutment - Month 12 change from day 10||||0.0086
71659660|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.86|||<|0.001|TWO_SIDED|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||24.63|7.08|<0.001
71661245|NCT02994940|142836114|SUPERIORITY||Hodges Lehman estimator|2.0||||0.109|TWO_SIDED|95.0|-1.0|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-1.0|0.109
71734281|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.94|||||TWO_SIDED|95.0|-3.57|14.15|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||14.15|-3.57|
71734282|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.88|||||TWO_SIDED|95.0|-1.77|16.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||16.52|-1.77|
71832040|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Sign test|||Change in Visible Control Abutment - Month 24 change from day 10||||0.0021
71832041|NCT01796236|143168565|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Sign test|||Change in Visible Control Abutment - Month 36 change from day 10||||0.0005
71832042|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||Week 12: Vascularity (observer)||||0.026
71832043|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vascularity (observer)||||0.33
71832044|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vascularity (observer)||||0.094
71832045|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pigmentation (observer)||||0.30
71832046|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pigmentation (observer)||||0.23
71832047|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pigmentation (observer)||||0.48
71832048|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (observer)||||0.0003
71832049|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (observer)||||0.062
71832050|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (observer)||||0.11
71832051|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Relief (observer)||||0.0003
71832052|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 12: Relief (observer)||||0.079
71832053|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Month 36: Relief (observer)||||0.025
71832054|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pliability (observer)||||0.0020
71734283|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.89|||||TWO_SIDED|95.0|-2.34|13.48|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||13.48|-2.34|
71734284|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.93|||||TWO_SIDED|95.0|-9.84|5.82|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||5.82|-9.84|
71734285|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.33|||||TWO_SIDED|95.0|30.25|54.6|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.60|30.25|
71734286|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|38.05|||||TWO_SIDED|95.0|23.93|48.58|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||48.58|23.93|
71734287|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.26|||||TWO_SIDED|95.0|28.15|49.72|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||49.72|28.15|
71734288|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.28|||||TWO_SIDED|95.0|-5.31|17.71|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||17.71|-5.31|
71734289|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.65|||||TWO_SIDED|95.0|19.25|37.65|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||37.65|19.25|
71734290|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.97|||||TWO_SIDED|95.0|19.6|37.95|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||37.95|19.60|
71734291|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.81|||||TWO_SIDED|95.0|19.5|37.76|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||37.76|19.50|
71773088|NCT05014490|143045839|EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. The level of significance was set to the standard value of 5% (0.05) for all statistical tests.|Ratio of the T/R geometric mean x 100|99.23|||||TWO_SIDED|90.0|96.97|101.54|||||The ratio of geometric LSmeans with corresponding 90% CI calculated from the exponential of the difference between the test and reference products for the ln-transformed parameters should be within the acceptance interval of 80.00 - 125.00%.|||101.54|96.97|
71773089|NCT03880461|143045854|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71773090|NCT03880461|143045855|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71734292|NCT02986854|142983834|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.32|||||TWO_SIDED|95.0|-2.56|1.86|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.86|-2.56|
71734293|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.78|||||TWO_SIDED|95.0|16.23|38.27|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.27|16.23|
71734294|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.4|||||TWO_SIDED|95.0|8.78|31.03|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||31.03|8.78|
71734295|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|24.14|||||TWO_SIDED|95.0|13.28|33.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.86|13.28|
71734296|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.37|||||TWO_SIDED|95.0|-0.76|15.42|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.42|-0.76|
71773091|NCT03880461|143045856|SUPERIORITY|||||||0.108|||||||ANOVA|||||||0.108
71773092|NCT04025710|143045882|OTHER|single arm design|SADE-free rate|0.97||||0.05|TWO_SIDED|95.0|0.9|1.0|||t-test, 2 sided|||The primary hypothesis evaluates the SADE free rate (pSADE\_free) at 3 months. Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%||1|0.9|0.05
71773093|NCT02431247|143045887|NON_INFERIORITY|One-sided p-value for non-inferiority of Test versus Control arm. The non-|Difference in percentage|2.7|||<|0.001|TWO_SIDED|95.0|-1.6|7.1||inferiority margin is 10%.|Mantel Haenszel|||||7.1|-1.6|< 0.001
71773094|NCT02431247|143045890|OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.063|=|0.437|TWO_SIDED|95.0|-0.171|0.074|||ANCOVA|||||0.074|-0.171|= 0.437
71832055|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pliability (observer)||||0.14
71832056|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pliability (observer)||||0.0014
71832057|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 12: Surface Area (observer)||||0.0001
71832058|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Month 12: Surface Area (observer)||||0.023
71734297|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|27.08|||||TWO_SIDED|95.0|11.04|42.14|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||42.14|11.04|
71734298|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|16.39|||||TWO_SIDED|95.0|0.04|31.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.90|0.04|
71773095|NCT02431247|143045891|OTHER||LS mean difference|18.48|STANDARD_ERROR_OF_MEAN|14.808|=|0.213|TWO_SIDED|95.0|-10.595|47.55|||ANCOVA|||||47.550|-10.595|= 0.213
71773096|NCT02431247|143045892|OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.008|<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||ANCOVA|||||-0.02|-0.05|< 0.001
71773097|NCT02431247|143045893|OTHER||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.786|<|0.001|TWO_SIDED|95.0|1.57|4.66|||ANCOVA|||||4.66|1.57|< 0.001
71773098|NCT02431247|143045894|OTHER||LS mean difference|6.04|STANDARD_ERROR_OF_MEAN|1.126|<|0.001|TWO_SIDED|95.0|3.83|8.25|||ANCOVA|||||8.25|3.83|< 0.001
71773099|NCT02431247|143045895|OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.747|=|0.001|TWO_SIDED|95.0|0.93|3.87|||ANCOVA|||||3.87|0.93|= 0.001
71773100|NCT02431247|143045897|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
71773101|NCT02431247|143045898|OTHER||||||=|0.033|||||||Wilcoxon rank sum test|||||||= 0.033
71773102|NCT02431247|143045899|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
71773103|NCT02431247|143045900|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||< 0.001
71773104|NCT02431247|143045901|OTHER||||||=|0.147|||||||Wilcoxon rank sum test|||||||= 0.147
71773105|NCT02431247|143045906|OTHER||LS mean difference|1.95|STANDARD_ERROR_OF_MEAN|0.368|<|0.001|TWO_SIDED|95.0|1.227|2.678|||ANCOVA|||Hip region BMD (Week 24)||2.678|1.227|< 0.001
71773106|NCT02431247|143045906|OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|1.934|3.791|||ANCOVA|||Hip region BMD (Week 48)||3.791|1.934|< 0.001
71773107|NCT02431247|143045906|OTHER||LS mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|1.259|2.919|||ANCOVA|||Spine region BMD (Week 24)||2.919|1.259|< 0.001
71773108|NCT02431247|143045906|OTHER||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.588|=|0.004|TWO_SIDED|95.0|0.539|2.858|||ANCOVA|||Spine region BMD (Week 48)||2.858|0.539|= 0.004
71773109|NCT01369485|143045946|SUPERIORITY_OR_OTHER|||||||0.3636|||||||Chi-squared|||The sample size calculation was determined using the 2-sided Chi-square test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥50% in mean urgency urinary incontinence episodes (leaks) between baseline and Week 12 of the study; (3) 20 % dropout rate.||||0.3636
71773110|NCT01369485|143045946|SUPERIORITY_OR_OTHER|||||||0.4849|||||||Chi-squared|||||||0.4849
71773111|NCT01369485|143045947|SUPERIORITY_OR_OTHER|||||||0.2893|||||||Wilcoxon (Mann-Whitney)|||||||0.2893
71773112|NCT01369485|143045947|SUPERIORITY_OR_OTHER|||||||0.3223|||||||Wilcoxon (Mann-Whitney)|||||||0.3223
71661246|NCT02994940|142836115|SUPERIORITY||Hodges Lehman estimator|7.0||||0.0001|TWO_SIDED|95.0|4.0|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|4.0|0.0001
71661247|NCT03233230|142836116|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1746|TWO_SIDED|95.0|0.84|2.61|||Regression, Logistic|||||2.61|0.84|0.1746
71773113|NCT01369485|143045948|SUPERIORITY_OR_OTHER|||||||0.3387|||||||Wilcoxon (Mann-Whitney)|||||||0.3387
71773114|NCT01369485|143045949|SUPERIORITY_OR_OTHER|||||||0.6557|||||||Wilcoxon (Mann-Whitney)|||||||0.6557
71773115|NCT01369485|143045950|SUPERIORITY_OR_OTHER|||||||0.4354|||||||Wilcoxon (Mann-Whitney)|||||||0.4354
71773116|NCT01369485|143045951|SUPERIORITY_OR_OTHER|||||||0.9918|||||||Wilcoxon (Mann-Whitney)|||||||0.9918
71773117|NCT01369485|143045951|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||||||0.3770
71773118|NCT01369485|143045952|SUPERIORITY_OR_OTHER|||||||0.4147|||||||Fisher Exact|||||||0.4147
71773119|NCT01369485|143045952|SUPERIORITY_OR_OTHER|||||||0.0877|||||||Fisher Exact|||||||0.0877
71773120|NCT01369485|143045953|SUPERIORITY_OR_OTHER|||||||0.2032|||||||Fisher Exact|||||||0.2032
71773121|NCT01369485|143045954|SUPERIORITY_OR_OTHER|||||||0.4151||||||Calculated for only those patients who had prior OAB treatment only.|Wilcoxon (Mann-Whitney)|||||||0.4151
71773122|NCT01369485|143045955|SUPERIORITY_OR_OTHER|||||||0.9814|||||||Fisher Exact|||"Endpoint defined as percentage of patients that much improved or very much improved following treatment."||||0.9814
71773123|NCT01369485|143045955|SUPERIORITY_OR_OTHER|||||||0.7305|||||||Fisher Exact|||||||0.7305
71773124|NCT01369485|143045956|SUPERIORITY_OR_OTHER|||||||0.2191|||||||Wilcoxon (Mann-Whitney)|||||||0.2191
71773125|NCT01369485|143045956|SUPERIORITY_OR_OTHER|||||||0.5357|||||||Wilcoxon (Mann-Whitney)|||||||0.5357
71773126|NCT01858636|143045958|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% upper confidence bound of 5.5%||Ho: Pt ≥ 8% Ha: Pt \< 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.||||0.0029
71773127|NCT01858636|143045959|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|A one-sided Fisher's exact test was performed with a 95% lower confidence bound of 96.4%||Ho: St ≤ 90% Ha: St \> 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.||||<0.0001
71832059|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||Month 36: Surface Area (observer)||||0.045
71832060|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (observer)||||0.0005
71832061|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (observer)||||0.085
71832062|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (observer)||||0.030
71832063|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (observer)||||0.0015
71832064|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Month 12: Overall Opinion (observer)||||0.076
71734299|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.85|||||TWO_SIDED|95.0|6.73|36.11|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||36.11|6.73|
71734300|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|10.69|||||TWO_SIDED|95.0|-0.42|21.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||21.60|-0.42|
71734301|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|44.4|||||TWO_SIDED|95.0|28.65|58.93|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||58.93|28.65|
71734302|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.9|||||TWO_SIDED|95.0|33.45|63.13|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.13|33.45|
71734303|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|46.61|||||TWO_SIDED|95.0|31.52|60.59|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||60.59|31.52|
71734304|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.5|||||TWO_SIDED|95.0|-11.84|2.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||2.69|-11.84|
71773128|NCT01436162|143046040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.92||0.583|TWO_SIDED|95.0|-2.3|1.3|||Mixed-effects Model for Repeat Measures|||||1.3|-2.3|0.583
71773129|NCT01436162|143046041|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.354|TWO_SIDED|95.0|-1.9|0.7|||Mixed-effects Model for Repeat Measures|||||0.7|-1.9|0.354
71773130|NCT05032859|143046054|SUPERIORITY||Risk Ratio, log|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|3.32|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||3.32|1.54|<0.0001
71773131|NCT05032859|143046055|SUPERIORITY||Risk Ratio, log|2.14|||<|0.0001|TWO_SIDED|95.0|1.53|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.53|<0.0001
71773132|NCT05032859|143046056|SUPERIORITY||Least squares mean difference|-6.6|STANDARD_ERROR_OF_MEAN|0.803|<|0.0001|TWO_SIDED|95.0|-8.17|-5.02|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-5.02|-8.17|<0.0001
71773133|NCT05032859|143046057|SUPERIORITY||Risk Ratio, log|2.34||||0.0013|TWO_SIDED|95.0|1.39|3.94|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.||Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|3.94|1.39|0.0013
71734305|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.9|||||TWO_SIDED|95.0|7.53|21.22|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||21.22|7.53|
71734306|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.55|||||TWO_SIDED|95.0|7.1|20.89|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||20.89|7.10|
71734307|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|12.73|||||TWO_SIDED|95.0|7.34|21.05|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||21.05|7.34|
71773134|NCT05032859|143046058|SUPERIORITY||Risk Ratio, log|2.17||||0.0015|TWO_SIDED|95.0|1.34|3.5|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.50|1.34|0.0015
71832065|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (observer)||||0.15
71832066|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12: Painful (patient)||||0.72
71832067|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12: Painful (patient)||||0.97
71832068|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 36: Painful (patient)||||0.82
71832069|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Week 12: Itching (patient)||||0.86
71832070|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 12: Itching (patient)||||0.84
71832071|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Itching (patient)||||0.76
71734308|NCT02986854|142983835|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
71734309|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.14|||||TWO_SIDED|95.0|3.46|25.39|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||25.39|3.46|
71734310|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.66|||||TWO_SIDED|95.0|5.0|26.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.89|5.00|
71734311|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.89|||||TWO_SIDED|95.0|4.91|25.62|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||25.62|4.91|
71734312|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.52|||||TWO_SIDED|95.0|-8.51|5.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||5.50|-8.51|
71734313|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.44|||||TWO_SIDED|95.0|5.25|34.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||34.83|5.25|
71734314|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.11|||||TWO_SIDED|95.0|5.88|35.5|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||35.50|5.88|
71734315|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|6.53|34.58|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||34.58|6.53|
71773135|NCT01535664|143046059|SUPERIORITY_OR_OTHER||Difference in least square means|4.04|STANDARD_ERROR_OF_MEAN|1.51||0.015|TWO_SIDED|95.0|0.87|7.2||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment.||The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall gait was the average of WA, TW, and SQT; a higher score is indicative of better performance.||7.20|0.87|0.015
71773136|NCT01535664|143046060|SUPERIORITY_OR_OTHER||Difference in least square means|1.7|STANDARD_ERROR_OF_MEAN|0.5||0.003|TWO_SIDED|95.0|0.7|2.8|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||2.8|0.7|0.003
71773137|NCT01535664|143046061|SUPERIORITY_OR_OTHER||Difference in least square means|7.729|STANDARD_ERROR_OF_MEAN|2.495||0.006|TWO_SIDED|95.0|2.507|12.95|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||12.950|2.507|0.006
71773138|NCT01535664|143046062|SUPERIORITY_OR_OTHER||Difference in least square means|0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.19|0.54|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||||0.54|0.19|<.001
71734316|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.66|||||TWO_SIDED|95.0|-9.67|8.4|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||8.40|-9.67|
71734317|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.2|||||TWO_SIDED|95.0|16.78|45.45|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||45.45|16.78|
71734318|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.22|||||TWO_SIDED|95.0|21.29|49.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||49.20|21.29|
71734319|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|32.17|||||TWO_SIDED|95.0|19.3|47.13|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||47.13|19.30|
71734320|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-4.02|||||TWO_SIDED|95.0|-9.45|0.74|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||0.74|-9.45|
71773139|NCT01535664|143046063|SUPERIORITY_OR_OTHER||Difference in least square means|-2.38|STANDARD_ERROR_OF_MEAN|2.97||0.434|TWO_SIDED|95.0|-8.6|3.84||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance was a weighted average of SOT, LOS, and ADT.||3.84|-8.60|0.434
71661248|NCT03233230|142836116|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8283|TWO_SIDED|95.0|0.61|1.87|||Regression, Logistic|||||1.87|0.61|0.8283
71773140|NCT00395538|143046086|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the year 1 biopsy.||||||0.015||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, 2 \& 4 combined as the dependent variable; biopsy year as the independent variable, covariate for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate was included because it would over-parameterize the model.||||0.015
71773141|NCT00395538|143046086|OTHER|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate included because it would over-parameterize the model.||||0.002
71734321|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||23.95|9.28|
71773142|NCT00395538|143046086|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.649||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Cn.BV/TV change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Cn.BV/TV, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.649
71773143|NCT00395538|143046087|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.N values for both their baseline and year 1 biopsies.||||||0.371||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.371
71773144|NCT00395538|143046087|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.129||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Po.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Po.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.129
71832072|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 12: Color (patient)||||0.41
71734322|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.95|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||23.95|9.28|
71734323|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.22|||||TWO_SIDED|95.0|9.28|23.94|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||23.94|9.28|
71734324|NCT02986854|142983836|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
71734325|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.75|||||TWO_SIDED|95.0|10.19|32.25|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||32.25|10.19|
71832073|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Month 12: Color (patient)||||0.98
71734326|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.72|||||TWO_SIDED|95.0|3.15|25.29|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||25.29|3.15|
71734327|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.27|||||TWO_SIDED|95.0|7.44|27.92|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.92|7.44|
71734328|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.03|||||TWO_SIDED|95.0|-1.2|15.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||15.17|-1.20|
71734329|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.91|||||TWO_SIDED|95.0|5.57|36.37|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||36.37|5.57|
71734330|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.46|||||TWO_SIDED|95.0|6.05|37.0|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||37.00|6.05|
71734331|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.18|||||TWO_SIDED|95.0|6.89|35.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||35.38|6.89|
71832074|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Color (patient)||||0.76
71659661|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71734332|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.55|||||TWO_SIDED|95.0|-12.11|11.03|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.03|-12.11|
71734333|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.06|||||TWO_SIDED|95.0|24.26|54.95|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.95|24.26|
71734334|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.4|||||TWO_SIDED|95.0|26.71|57.17|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||57.17|26.71|
71734335|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.21|||||TWO_SIDED|95.0|26.12|55.55|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.55|26.12|
71734336|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-2.34|||||TWO_SIDED|95.0|-10.41|5.73|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||5.73|-10.41|
71734337|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.58|||||TWO_SIDED|95.0|15.26|32.08|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||32.08|15.26|
71734338|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.22|||||TWO_SIDED|95.0|14.86|31.74|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||31.74|14.86|
71734339|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.41|||||TWO_SIDED|95.0|15.08|31.9|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||31.90|15.08|
71734340|NCT02986854|142983837|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.36|||||TWO_SIDED|95.0|-0.96|1.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.99|-0.96|
71734341|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.23|||||TWO_SIDED|95.0|2.08|11.23|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||11.23|2.08|
71832075|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 12: Stiffness (patient)||||0.43
71832076|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 12: Stiffness (patient)||||0.25
71832077|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Month 36: Stiffness (patient)||||0.017
71832078|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (patient)||||0.13
71661249|NCT03233230|142836116|SUPERIORITY||Odds Ratio (OR)|1.55||||0.1298|TWO_SIDED|95.0|0.88|2.74|||Regression, Logistic|||||2.74|0.88|0.1298
71832079|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (patient)||||0.33
71832080|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (patient)||||0.65
71832081|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Week 12: Irregularity (patient)||||0.18
71832082|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Irregularity (patient)||||0.38
71832083|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Month 36: Irregularity (patient)||||0.080
71734342|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|8.5|||||TWO_SIDED|95.0|3.28|12.74|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||12.74|3.28|
71734343|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|7.86|||||TWO_SIDED|95.0|2.87|10.78|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.78|2.87|
71734344|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-1.27|||||TWO_SIDED|95.0|-6.1|3.49|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||3.49|-6.10|
71734345|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.25|||||TWO_SIDED|95.0|-3.04|12.44|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||12.44|-3.04|
71734346|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.61|||||TWO_SIDED|95.0|-2.71|13.01|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||13.01|-2.71|
71773145|NCT00395538|143046087|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.538||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.538
71661250|NCT03233230|142836117|SUPERIORITY||Response rate difference|0.13||||0.0077|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0077
71734347|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|6.43|||||TWO_SIDED|95.0|-2.66|10.9|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||10.90|-2.66|
71734348|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.36|||||TWO_SIDED|95.0|-7.27|6.43|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||6.43|-7.27|
71773146|NCT00395538|143046088|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the year 1 biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|A baseline covariate not added to model since it would over-parameterize the model.||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
71832084|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (patient)||||0.28
71832085|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (patient)||||0.44
71832086|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (patient)||||0.19
71832087|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.16
71832088|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)||||0.23
71832089|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (patient)||||0.079
71734349|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|41.34|||||TWO_SIDED|95.0|28.85|50.63|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||50.63|28.85|
71734350|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|36.88|||||TWO_SIDED|95.0|24.39|46.34|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||46.34|24.39|
71734351|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.16|||||TWO_SIDED|95.0|27.61|46.33|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||46.33|27.61|
71832090|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pain not within Scar (patient)||||0.0018
71832091|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain not within Scar (patient)||||0.053
71832092|NCT01796236|143168566|SUPERIORITY_OR_OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain not within Scar (patient)||||0.068
71734352|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.46|||||TWO_SIDED|95.0|-7.04|15.83|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||15.83|-7.04|
71734353|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.61|||||TWO_SIDED|95.0|22.68|41.79|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||41.79|22.68|
71734354|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.85|||||TWO_SIDED|95.0|21.85|41.08|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||41.08|21.85|
71734355|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|31.24|||||TWO_SIDED|95.0|22.39|41.38|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||41.38|22.39|
71734356|NCT02986854|142983838|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.76|||||TWO_SIDED|95.0|-1.81|3.52|||Miettinen & Nurminen score method|||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.52|-1.81|
71734357|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|30.02|||||TWO_SIDED|95.0|19.55|38.83|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||38.83|19.55|
71734358|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.87|||||TWO_SIDED|95.0|10.48|29.69|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.69|10.48|
71734359|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.5|||||TWO_SIDED|95.0|15.79|33.21|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.21|15.79|
71734360|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.14|||||TWO_SIDED|95.0|1.01|17.16|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||17.16|1.01|
71734361|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|25.0|||||TWO_SIDED|95.0|8.82|38.9|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||38.90|8.82|
71734362|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|15.76|||||TWO_SIDED|95.0|-0.44|29.86|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||29.86|-0.44|
71734363|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|20.48|||||TWO_SIDED|95.0|5.32|33.08|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.08|5.32|
71734364|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|9.24|||||TWO_SIDED|95.0|-2.45|20.68|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||20.68|-2.45|
71734365|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|50.25|||||TWO_SIDED|95.0|34.09|63.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||63.67|34.09|
71734366|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.48|||||TWO_SIDED|95.0|33.21|63.01|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||63.01|33.21|
71734367|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|49.87|||||TWO_SIDED|95.0|34.42|62.6|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||62.60|34.42|
71734368|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.77|||||TWO_SIDED|95.0|-8.3|9.92|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||9.92|-8.30|
71734369|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.34|39.75|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||39.75|21.34|
71661251|NCT03233230|142836117|SUPERIORITY||Response rate difference|0.17||||0.0013|TWO_SIDED|95.0|0.07|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.07|0.0013
71734370|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.75|||||TWO_SIDED|95.0|21.32|39.74|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||39.74|21.32|
71734371|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|29.76|||||TWO_SIDED|95.0|21.35|39.73|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||39.73|21.35|
71734372|NCT02986854|142983839|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.01|||||TWO_SIDED|95.0|-1.6|1.67|||Miettinen & Nurminen score method|||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.67|-1.60|
71734373|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.36|||||TWO_SIDED|95.0|5.85|28.67|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||28.67|5.85|
71734374|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.92|||||TWO_SIDED|95.0|6.39|29.25|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||29.25|6.39|
71734375|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.64|||||TWO_SIDED|95.0|6.85|28.28|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.28|6.85|
71734376|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-0.57|||||TWO_SIDED|95.0|-8.32|7.2|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||7.20|-8.32|
71734377|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|14.58|||||TWO_SIDED|95.0|-0.98|30.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.38|-0.98|
71734378|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|22.64|||||TWO_SIDED|95.0|7.3|38.16|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||38.16|7.30|
71773147|NCT00395538|143046088|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71832093|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI3)||||0.90
71661252|NCT03233230|142836117|SUPERIORITY||Response rate difference|0.13||||0.008|TWO_SIDED|95.0|0.04|0.23|||Cochran-Mantel-Haenszel|||||0.23|0.04|0.0080
71734379|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.53|||||TWO_SIDED|95.0|4.14|33.37|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||33.37|4.14|
71734380|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-8.06|||||TWO_SIDED|95.0|-18.34|2.38|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||2.38|-18.34|
71734381|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|39.04|||||TWO_SIDED|95.0|23.76|54.07|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||54.07|23.76|
71734382|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|42.14|||||TWO_SIDED|95.0|27.08|56.98|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||56.98|27.08|
71734383|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|40.56|||||TWO_SIDED|95.0|25.91|55.15|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||55.15|25.91|
71734384|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|-3.1|||||TWO_SIDED|95.0|-10.2|3.89|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||3.89|-10.20|
71734385|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||28.83|12.74|
71773148|NCT00395538|143046088|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.374||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.374
71773149|NCT00395538|143046089|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
71773150|NCT00395538|143046089|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71773151|NCT00395538|143046089|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.168||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.168
71773152|NCT00395538|143046090|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.BFR/BS values for both their baseline and year 1 biopsies.||||||0.083||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.083
71773153|NCT00395538|143046090|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71832094|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI3)||||0.43
71661253|NCT03233230|142836118|SUPERIORITY||Response rate difference|0.09||||0.0056|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0056
71832095|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI3)||||0.23
71832096|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI3)||||0.019
71832097|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Baseline: Vision (HUI3)||||0.079
71832098|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Vision (HUI3)||||0.96
71832099|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vision (HUI3)||||0.55
71832100|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vision (HUI3)||||0.64
71832101|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Baseline: Hearing (HUI3)||||0.76
71661254|NCT03233230|142836118|SUPERIORITY||Response rate difference|0.09||||0.005|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0050
71832102|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||Week 24: Hearing (HUI3)||||0.059
71832103|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Hearing (HUI3)||||0.38
71734386|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.74|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||28.83|12.74|
71734387|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.57|||||TWO_SIDED|95.0|12.75|28.83|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||28.83|12.75|
71734388|NCT02986854|142983840|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.0|||||TWO_SIDED|95.0|-1.31|1.35|||Miettinen & Nurminen score method|||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||1.35|-1.31|
71734389|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|21.82|||||TWO_SIDED|95.0|11.44|30.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)||30.60|11.44|
71734390|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|17.67|||||TWO_SIDED|95.0|7.34|26.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)||26.43|7.34|
71734391|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|19.77|||||TWO_SIDED|95.0|10.09|27.43|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||27.43|10.09|
71734392|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|4.15|||||TWO_SIDED|95.0|-3.8|12.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)||12.04|-3.80|
71734393|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.33|||||TWO_SIDED|95.0|2.92|30.99|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)||30.99|2.92|
71734394|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.3|||||TWO_SIDED|95.0|2.83|31.06|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)||31.06|2.83|
71734395|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|18.31|||||TWO_SIDED|95.0|3.83|29.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||29.39|3.83|
71734396|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.03|||||TWO_SIDED|95.0|-11.35|11.39|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)||11.39|-11.35|
71734397|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.87|||||TWO_SIDED|95.0|32.64|62.38|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)||62.38|32.64|
71734398|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.18|||||TWO_SIDED|95.0|31.87|61.79|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)||61.79|31.87|
71734399|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|48.53|||||TWO_SIDED|95.0|33.04|61.31|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||61.31|33.04|
71734400|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|0.69|||||TWO_SIDED|95.0|-8.6|10.04|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)||10.04|-8.60|
71734401|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|35.48|||||TWO_SIDED|95.0|26.5|45.62|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)||45.62|26.50|
71734402|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.06|||||TWO_SIDED|95.0|24.94|44.28|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)||44.28|24.94|
71734403|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|34.78|||||TWO_SIDED|95.0|25.78|44.93|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||44.93|25.78|
71734404|NCT02986854|142983841|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Between groups differences in percentage|1.42|||||TWO_SIDED|95.0|0.1|3.6|||Miettinen & Nurminen score method|||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)||3.60|0.10|
71832104|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Hearing (HUI3)||||0.14
71734405|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.39|||||TWO_SIDED|95.0|-6.08|4.94|||Miettinen & Nurminen score method|||Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)||4.94|-6.08|
71734406|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.17|||||TWO_SIDED|95.0|-5.32|6.21|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||6.21|-5.32|
71734407|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.77|||||TWO_SIDED|95.0|-5.68|4.09|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.09|-5.68|
71734408|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.79|||||TWO_SIDED|95.0|-4.98|3.01|||Miettinen & Nurminen score method|||Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.01|-4.98|
71734409|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|34.76|||||TWO_SIDED|95.0|22.38|44.07|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||44.07|22.38|
71734410|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|26.88|||||TWO_SIDED|95.0|14.67|36.13|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||36.13|14.67|
71734411|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|30.89|||||TWO_SIDED|95.0|19.42|37.97|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||37.97|19.42|
71734412|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.88|||||TWO_SIDED|95.0|-3.25|18.81|||Miettinen & Nurminen score method|||Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||18.81|-3.25|
71734413|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.45|||||TWO_SIDED|95.0|-14.26|2.35|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.35|-14.26|
71734414|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|2.51|||||TWO_SIDED|95.0|-8.7|9.98|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.98|-8.70|
71734415|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-0.54|||||TWO_SIDED|95.0|-11.35|4.9|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.90|-11.35|
71734416|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-5.96|||||TWO_SIDED|95.0|-12.25|-0.57|||Miettinen & Nurminen score method|||Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-0.57|-12.25|
71734417|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|40.03|||||TWO_SIDED|95.0|25.37|50.92|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.92|25.37|
71832105|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Baseline: Speech (HUI3)||||0.73
71734418|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|36.84|||||TWO_SIDED|95.0|22.14|47.9|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||47.90|22.14|
71734419|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.79|47.57|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.57|24.79|
71734420|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.19|||||TWO_SIDED|95.0|-8.44|14.73|||Miettinen & Nurminen score method|||Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||14.73|-8.44|
71734421|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-3.47|||||TWO_SIDED|95.0|-14.28|2.31|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||2.31|-14.28|
71734422|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.89|||||TWO_SIDED|95.0|-7.4|11.6|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||11.60|-7.40|
71734423|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|0.13|||||TWO_SIDED|95.0|-10.7|5.66|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||5.66|-10.70|
71734424|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-7.37|||||TWO_SIDED|95.0|-13.89|-1.8|||Miettinen & Nurminen score method|||Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||-1.80|-13.89|
71832106|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Week 24: Speech (HUI3)||||0.65
71832107|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Month 12: Speech (HUI3)||||1.00
71734425|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.98|||||TWO_SIDED|95.0|24.35|49.88|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||49.88|24.35|
71734426|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|37.92|||||TWO_SIDED|95.0|23.23|48.95|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||48.95|23.23|
71734427|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|38.46|||||TWO_SIDED|95.0|24.8|47.56|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||47.56|24.80|
71734428|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|1.06|||||TWO_SIDED|95.0|-10.51|12.6|||Miettinen & Nurminen score method|||Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||12.60|-10.51|
71734429|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|7.75|||||TWO_SIDED|95.0|0.15|13.36|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)||13.36|0.15|
71734430|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|4.38|||||TWO_SIDED|95.0|-3.15|9.24|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)||9.24|-3.15|
71734431|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|6.09|||||TWO_SIDED|95.0|-1.41|9.55|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.55|-1.41|
71734432|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|3.37|||||TWO_SIDED|95.0|-2.48|9.54|||Miettinen & Nurminen score method|||Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||9.54|-2.48|
71773154|NCT00395538|143046090|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.164||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.164
71773155|NCT00395538|143046091|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MS/BS values for both their baseline and year 1 biopsies.||||||0.031||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.031
71773156|NCT00395538|143046091|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71773157|NCT00395538|143046091|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.178||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.178
71832108|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Month 36: Speech (HUI3)||||0.35
71832109|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ambulation (HUI3)||||0.50
71832110|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ambulation (HUI3)||||0.40
71832111|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ambulation (HUI3)||||0.21
71832112|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ambulation (HUI3)||||0.0010
71832113|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI3)||||0.13
71832114|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI3)||||0.96
71734433|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|39.86|||||TWO_SIDED|95.0|25.76|50.29|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)||50.29|25.76|
71773158|NCT00395538|143046092|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.BFR/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71773159|NCT00395538|143046092|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
71773160|NCT00395538|143046092|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.172||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.172
71773161|NCT00395538|143046093|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71773162|NCT00395538|143046093|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.018||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.018
71773163|NCT00395538|143046093|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.155||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.155
71734434|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|48.05|||||TWO_SIDED|95.0|33.89|58.34|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)||58.34|33.89|
71734435|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|43.91|||||TWO_SIDED|95.0|30.79|52.37|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||52.37|30.79|
71773164|NCT00395538|143046094|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the year 1 biopsy.||||||0.72||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.720
71734436|NCT02986854|142983842|OTHER|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen \& Nurminen score method|Differences in percentage|-8.19|||||TWO_SIDED|95.0|-19.61|3.45|||Miettinen & Nurminen score method|||Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)||3.45|-19.61|
71734437|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.26|||||TWO_SIDED|95.0|0.93|1.7||||||Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)||1.70|0.93|
71734438|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.34|||||TWO_SIDED|95.0|0.98|1.82||||||Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)||1.82|0.98|
71734439|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.29|||||TWO_SIDED|95.0|0.97|1.72||||||Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)||1.72|0.97|
71734440|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.17|0.76|
71734441|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|5.19|||||TWO_SIDED|95.0|2.84|9.47||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||9.47|2.84|
71734442|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.1|||||TWO_SIDED|95.0|2.24|7.5||||||Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||7.50|2.24|
71734443|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.62|||||TWO_SIDED|95.0|2.62|8.15||||||Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||8.15|2.62|
71734444|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.27|||||TWO_SIDED|95.0|0.84|1.91||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.91|0.84|
71773165|NCT00395538|143046094|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.944||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.944
71832115|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI3)||||0.75
71832116|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI3)||||0.20
71734445|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.54|||||TWO_SIDED|95.0|4.84|8.85||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||8.85|4.84|
71889466|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-33.9|||<|0.001|TWO_SIDED|95.0|-46.4|-21.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-21.5|-46.4|<0.001
71734446|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.37|||||TWO_SIDED|95.0|5.44|9.98||||||Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||9.98|5.44|
71734447|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.94|||||TWO_SIDED|95.0|5.23|9.21||||||Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||9.21|5.23|
71832117|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI3)||||0.95
71832118|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI3)||||0.31
71832119|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI3)||||0.15
71832120|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI3)||||0.19
71832121|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI3)||||0.41
71734448|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.72|
71734449|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|between group GMT ratios|3.43|||||TWO_SIDED|95.0|1.95|6.04||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||6.04|1.95|
71734450|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.21|3.77||||||Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||3.77|1.21|
71734451|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.72|||||TWO_SIDED|95.0|1.6|4.64||||||Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.64|1.60|
71734452|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.61|||||TWO_SIDED|95.0|1.07|2.4||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||2.40|1.07|
71734453|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.75|||||TWO_SIDED|95.0|7.51|25.19||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||25.19|7.51|
71734454|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.42|||||TWO_SIDED|95.0|7.31|24.66||||||Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||24.66|7.31|
71734455|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.59|||||TWO_SIDED|95.0|7.7|24.0||||||Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||24.00|7.70|
71734456|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.02|||||TWO_SIDED|95.0|0.67|1.56||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.56|0.67|
71734457|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|19.43|||||TWO_SIDED|95.0|13.73|27.51||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||27.51|13.73|
71659662|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|42.94|||<|0.001|TWO_SIDED|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.44|29.44|<0.001
71734458|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|17.72|||||TWO_SIDED|95.0|12.5|25.12||||||Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||25.12|12.50|
71734459|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|18.57|||||TWO_SIDED|95.0|13.4|25.73||||||Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||25.73|13.40|
71734460|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.1|||||TWO_SIDED|95.0|0.86|1.4||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.40|0.86|
71832122|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI3)||||0.30
71832123|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI3)||||0.42
71832124|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI3)||||0.040
71832125|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI2)||||0.99
71832126|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI2)||||0.88
71832127|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI2)||||0.32
71832128|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.0084|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI2)||||0.0084
71832129|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Baseline: Sensation (HUI2)||||0.77
71832130|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Week 24: Sensation (HUI2)||||0.95
71832131|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Month 12: Sensation (HUI2)||||0.60
71773166|NCT00395538|143046094|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.73||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.730
71773167|NCT00395538|143046095|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the year 1 biopsy.||||||0.019||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.019
71773168|NCT00395538|143046095|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.017||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.017
71773169|NCT00395538|143046095|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.843||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.843
71773170|NCT00395538|143046096|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the year 1 biopsy.||||||0.013||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.013
71773171|NCT00395538|143046096|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the years 2 and 4 (combined) biopsy.||||||0.025||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.025
71775093|NCT01920555|143050513|SUPERIORITY||Mean Difference (Final Values)|-9.85||||0.02|TWO_SIDED|95.0|-16.56|-3.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-3.15|-16.56|0.02
71832132|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Sensation (HUI2)||||0.48
71832133|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Baseline: Mobility (HUI2)||||0.51
71832134|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Week 24: Mobility (HUI2)||||0.42
71832135|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Month 12: Mobility (HUI2)||||0.22
71832136|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Month 36: Mobility (HUI2)||||0.0018
71832137|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI2)||||0.30
71889467|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-33.2|||<|0.001|TWO_SIDED|95.0|-46.3|-20.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-20.2|-46.3|<0.001
71773172|NCT00395538|143046096|OTHER|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.608||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.608
71773173|NCT00395538|143046097|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Th values for both their baseline and year 1 biopsies.||||||0.043||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.043
71773174|NCT00395538|143046097|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.334||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.334
71773175|NCT00395538|143046097|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.269||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Th change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Th, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).||||0.269
71773176|NCT00395538|143046098|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Ar values for both their baseline and year 1 biopsies.||||||0.358||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.358
71773177|NCT00395538|143046098|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.76||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.760
71775094|NCT01920555|143050513|SUPERIORITY||Mean Difference (Final Values)|-7.72||||0.08|TWO_SIDED|95.0|-14.52|-0.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.93|-14.52|0.08
71775095|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.08|TWO_SIDED|95.0|-1.83|-0.22|||Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.22|-1.83|0.08
71832138|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI2)||||0.52
71832139|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI2)||||0.47
71832140|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI2)||||0.18
71832141|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI2)||||0.82
71832142|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI2)||||0.41
71773178|NCT00395538|143046098|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.57||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.570
71773179|NCT00395538|143046099|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.Ar values for both their baseline and year 1 biopsies.||||||0.166||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.166
71773180|NCT00395538|143046099|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.895||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.895
71773181|NCT00395538|143046099|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.282||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.282
71773182|NCT00395538|143046100|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
71832143|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI2)||||0.14
71734461|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.88|||||TWO_SIDED|95.0|1.13|3.11||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||3.11|1.13|
71734462|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.46|||||TWO_SIDED|95.0|1.48|4.08||||||Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.08|1.48|
71832144|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI2)||||0.25
71832145|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline: Self Care (HUI2)||||0.59
71832146|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Week 24: Self Care (HUI2)||||1.00
71734463|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||TWO_SIDED|95.0|1.33|3.44||||||Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||3.44|1.33|
71832147|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Self Care (HUI2)||||0.55
71832148|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Self Care (HUI2)||||0.14
71832149|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI2)||||0.75
71832150|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI2)||||0.63
71832151|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI2)||||0.57
71734464|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.10|0.53|
71734465|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.04|||||TWO_SIDED|95.0|4.05|12.22||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||12.22|4.05|
71734466|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|8.99|||||TWO_SIDED|95.0|5.16|15.66||||||Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||15.66|5.16|
71734467|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.94|||||TWO_SIDED|95.0|4.72|13.35||||||Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||13.35|4.72|
71734468|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.78|||||TWO_SIDED|95.0|0.54|1.14||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.14|0.54|
71734469|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|25.21|||||TWO_SIDED|95.0|17.83|35.65||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||35.65|17.83|
71734470|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|34.06|||||TWO_SIDED|95.0|24.06|48.23||||||Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||48.23|24.06|
71734471|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|29.24|||||TWO_SIDED|95.0|21.09|40.52||||||Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||40.52|21.09|
71734472|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.74|||||TWO_SIDED|95.0|0.58|0.94||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||0.94|0.58|
71734473|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.35|||||TWO_SIDED|95.0|1.36|4.07||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)||4.07|1.36|
71734474|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.62|||||TWO_SIDED|95.0|1.51|4.54||||||Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)||4.54|1.51|
71734475|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.48|||||TWO_SIDED|95.0|1.48|4.14||||||Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||4.14|1.48|
71734476|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.9|||||TWO_SIDED|95.0|0.61|1.33||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)||1.33|0.61|
71734477|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.82|||||TWO_SIDED|95.0|5.47|17.64||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)||17.64|5.47|
71734478|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.55|||||TWO_SIDED|95.0|5.31|17.19||||||Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)||17.19|5.31|
71734479|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.69|||||TWO_SIDED|95.0|5.59|16.79||||||Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||16.79|5.59|
71832152|NCT01796236|143168567|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI2)||||0.019
71832153|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Aided)||||0.047
71832154|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Aided)||||0.23
71832155|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Aided)||||0.015
71734480|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.03|||||TWO_SIDED|95.0|0.69|1.54||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)||1.54|0.69|
71734481|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|28.52|||||TWO_SIDED|95.0|20.23|40.2||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)||40.20|20.23|
71734482|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|26.94|||||TWO_SIDED|95.0|19.09|38.02||||||Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)||38.02|19.09|
71734483|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|27.73|||||TWO_SIDED|95.0|20.1|38.26||||||Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)||38.26|20.10|
71734484|NCT02986854|142983843|OTHER|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.06|||||TWO_SIDED|95.0|0.83|1.35||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)||1.35|0.83|
71734485|NCT00324233|142983845|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||equivalence testing|||||||0.56
71734486|NCT01707381|142983864|OTHER||Treatment difference|-1.773|||<|0.001|TWO_SIDED|95.0|-2.38|-1.166|||ANCOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-1.166|-2.380|<0.001
71734487|NCT01707381|142983865|OTHER||Bonferroni t-test used for paired compar|0.01|||<|0.05|TWO_SIDED||||||ANOVA||the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group|Statistical analysis of nocturnal (supine) OPP was performed among baseline, the BOL-303259-X treatment and timolol treatment using ANOVA. the criteria for statistical significance was P\<0.05. Post hoc Bonferroni T-tests were then utilized to compare BOL and timolol groups.||||<0.05
71734488|NCT01707381|142983866|OTHER||Mean Difference (Final Values)|-1.77||||0.004|TWO_SIDED|95.0|-2.915|-0.625|||ANOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.|||-0.625|-2.915|0.004
71734489|NCT00086411|142983868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.2734|<|0.017|TWO_SIDED|95.0|0.77|2.25||The p-value was adjusted for multiple comparisons.|GEE model for repeated binary outcomes|Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race|The above was for the main effect of BUP versus NTX on cessation.|Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.||2.25|0.77|<0.017
71773183|NCT00395538|143046100|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71773184|NCT00395538|143046100|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.68||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.680
71734490|NCT03495102|142983916|SUPERIORITY||Mean Difference (Net)|-0.17||||0.003|TWO_SIDED|95.0|-0.29|-0.06|||Mixed Models Analysis|||||-0.06|-0.29|0.003
71734491|NCT03495102|142983916|SUPERIORITY||Mean Difference (Net)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.45|-0.22|||Mixed Models Analysis|||||-0.22|-0.45|<0.001
71734492|NCT03495102|142983917|SUPERIORITY||Mean Difference (Net)|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||||-0.4|-1.4|0.001
71734493|NCT03495102|142983917|SUPERIORITY||Mean Difference (Net)|-1.6|||<|0.001|TWO_SIDED|95.0|-2.1|-1.1|||Mixed Models Analysis|||||-1.1|-2.1|<0.001
71734494|NCT03495102|142983918|SUPERIORITY||Odds Ratio (OR)|1.49||||0.006|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||||1.98|1.12|0.006
71734495|NCT03495102|142983918|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.001|TWO_SIDED|95.0|1.65|3.01|||Regression, Logistic|||||3.01|1.65|<0.001
71734496|NCT03495102|142983919|SUPERIORITY||Mean Difference (Net)|-3.7||||0.084|TWO_SIDED|95.0|-7.8|0.5|||Mixed Models Analysis|||||0.5|-7.8|0.084
71734497|NCT03495102|142983919|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-12.3|-3.9|||Mixed Models Analysis|||||-3.9|-12.3|<0.001
71734498|NCT00321464|142983936|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82|||<|0.0001||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|<0.0001
71734499|NCT00321464|142983937|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.01||95.0|0.71|0.95||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.95|0.71|0.010
71734500|NCT00321464|142983938|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.77||||0.001||95.0|0.66|0.89||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Anderson-Gill model||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).|||0.89|0.66|0.001
71734501|NCT02593825|142983939|SUPERIORITY|Significance was based on α = .05. Hedges' g, corrected for small sample bias, was calculated as a measure of effect size using the model-predicted group differences in rate of change in the numerator and the pooled standard deviation estimated from the 3 or 12 month assessment (for short- and long-term effects, respectively) in the denominator.|Slope|1.14|||<|0.05|TWO_SIDED|||||Piecewise linear mixed modeling (LMM) was performed to address the study questions. LMM was necessary to account for repeated measures nested within children.|Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months) and post-intervention (3 to 12 months) phases, and accounted for variation in the time between assessments across children. All models controlled for intercept-level differences by site, as well as intercept- and slope-level differences by baseline-adjusted age and motor severity. Intervention effects were derived via intervention by slope interaction terms. Three-way interaction terms were subsequently added to the models to obtain intervention effects stratified by severity.|||<0.05
71734502|NCT02593825|142983940|SUPERIORITY||Mean Difference (Final Values)|0.192||||0.05|TWO_SIDED||||||Linear piecewise modeling|||||||.05
71734503|NCT02593825|142983941|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED||||||Mixed Models Analysis||data shown is for the 12 month time point for the severely delayed group comparison|Also examined these groups in sub-groups of mildly delayed (\<2.5 Standard Deviations below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5 Standard Deviations below the mean on motor Bayley score at baseline)||||<0.05
71734504|NCT02593825|142983943|SUPERIORITY||Slope|1.02|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|LMM was necessary to account for repeated measures nested within children. Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months).|||<0.05
71734505|NCT02593825|142983944|SUPERIORITY||Slope|8.7|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Also examined these groups in sub-groups of mildly delayed (\<2.5SD below the mean on motor Bayley score at baseline) and significantly motor delayed (\>2.5SD below the mean on motor Bayley score at baseline)|Piecewise modeling, using individually-varying timepoints, allowed separate slopes to be estimated across the intervention (baseline to 3 months)|||<0.05
71734506|NCT02593825|142983945|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.417|TWO_SIDED||||||Mixed Models Analysis|||||||0.417
71734507|NCT01209078|142983973|SUPERIORITY_OR_OTHER||Difference|-22.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.||||
71734508|NCT01209078|142983973|SUPERIORITY_OR_OTHER||Difference|-24.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.||||
71734509|NCT01209078|142983974|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
71734510|NCT01209078|142983975|SUPERIORITY_OR_OTHER||Difference|-35.0|||||TWO_SIDED|95.0|-60.6|-9.4|||Regression, Logistic|||||-9.4|-60.6|
71734511|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.41|0.74|||Mixed Models Analysis|||GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.||0.74|-0.41|
71734512|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.7|0.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.||0.45|-0.70|
71734513|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.74|0.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.||0.43|-0.74|
71734514|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|||||TWO_SIDED|95.0|-0.25|0.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.||0.95|-0.25|
71734515|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.49|0.72|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.||0.72|-0.49|
71734516|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.53|0.66|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.||0.66|-0.53|
71734517|NCT01209078|142983978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.65|0.58|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.||0.58|-0.65|
71832156|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Aided)||||0.13
71832157|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Aided)||||0.041
71832158|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Unaided)||||0.071
71734518|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
71734519|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
71734520|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
71734521|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
71734522|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
71734523|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
71734524|NCT01209078|142983979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
71734525|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|||||TWO_SIDED|95.0|-3.04|1.33|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.||1.33|-3.04|
71734526|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-2.94|1.41|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.||1.41|-2.94|
71734527|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54|||||TWO_SIDED|95.0|-1.68|2.75|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.||2.75|-1.68|
71734528|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79|||||TWO_SIDED|95.0|-0.46|4.05|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.||4.05|-0.46|
71734529|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|-1.09|3.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.||3.47|-1.09|
71734530|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-1.49|2.98|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.||2.98|-1.49|
71734531|NCT01209078|142983980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-2.09|2.52|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.||2.52|-2.09|
71734532|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.85|||||TWO_SIDED|95.0|-132.8|-4.95|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.||-4.95|-132.8|
71832159|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Unaided)||||0.75
71832160|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Unaided)||||0.32
71832161|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Unaided)||||0.24
71832162|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Unaided)||||0.24
71832163|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Benefit)||||0.12
71832164|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Benefit)||||0.19
71832165|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Benefit)||||0.055
71832166|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Benefit)||||0.24
71832167|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Benefit)||||0.042
71832168|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Aided)||||0.19
71832169|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Aided)||||0.99
71659663|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|9.23||||0.048|TWO_SIDED|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||18.40|0.06|0.048
71734533|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06|||||TWO_SIDED|95.0|-66.54|60.43|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.||60.43|-66.54|
71734534|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Median Difference (Net)|31.47|||||TWO_SIDED|95.0|-33.53|96.47|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.||96.47|-33.53|
71734535|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.94|||||TWO_SIDED|95.0|-22.43|110.31|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.||110.31|-22.43|
71734536|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.21|||||TWO_SIDED|95.0|-33.03|101.45|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.||101.45|-33.03|
71734537|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.57|||||TWO_SIDED|95.0|-28.25|103.4|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.||103.40|-28.25|
71734538|NCT01209078|142983981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.4|||||TWO_SIDED|95.0|-30.77|105.56|||Mixed Models Analysis||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.||105.56|-30.77|
71734539|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|-35.4|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).||||
71734540|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.||||
71773185|NCT00395538|143046101|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the year 1 biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
71659664|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||71.49|45.93|<0.001
71734541|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|-28.6|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.||||
71734542|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|-66.7|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.||||
71661255|NCT03233230|142836118|SUPERIORITY||Response rate difference|0.09||||0.0053|TWO_SIDED|95.0|0.03|0.17|||Cochran-Mantel-Haenszel|||||0.17|0.03|0.0053
71734543|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|-25.0|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.||||
71734544|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|-37.5|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.||||
71734545|NCT01209078|142983982|SUPERIORITY_OR_OTHER||Difference|2.2|||||||||||Regression, Logistic|||GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.||||
71832170|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Aided)||||0.24
71832171|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Aided)||||0.73
71661256|NCT03233230|142836119|SUPERIORITY||Response rate difference|0.09||||0.1419|TWO_SIDED|95.0|-0.03|0.21|||Cochran-Mantel-Haenszel|||||0.21|-0.03|0.1419
71734546|NCT00924508|142983984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
71734547|NCT00924508|142983984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
71734548|NCT00924508|142983984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Baseline and post-treatment comparison||||<0.001
71734549|NCT01755455|142983986|SUPERIORITY_OR_OTHER|||||||0.81|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||0.81
71734550|NCT01755455|142983987|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||||||<0.05
71734551|NCT01755455|142983988|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).||||<0.05
71734552|NCT01755455|142983989|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fixed-effect model|||||||0.16
71734553|NCT01754493|142984007|SUPERIORITY_OR_OTHER_LEGACY||Slope|-18.24|||<|0.05|TWO_SIDED|95.0|-23.44|-12.63|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-12.63|-23.44|<.05
71832172|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Aided)||||0.39
71832173|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Unaided)||||0.24
71832174|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Unaided)||||0.81
71832175|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Unaided)||||0.34
71889468|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-24.7|||<|0.001|TWO_SIDED|95.0|-37.1|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-37.1|<0.001
71734554|NCT01754493|142984008|SUPERIORITY_OR_OTHER_LEGACY||Slope|-20.71|||<|0.05|TWO_SIDED|95.0|-27.44|-13.97|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-13.97|-27.44|<0.05
71734555|NCT01754493|142984009|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.59|||<|0.05|TWO_SIDED|95.0|-2.16|-1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.03|-2.16|<0.05
71734556|NCT01754493|142984009|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.55|||<|0.05|TWO_SIDED|95.0|-1.99|-1.11|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.11|-1.99|<0.05
71734557|NCT01754493|142984010|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.03|||<|0.05|TWO_SIDED|95.0|-1.16|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-1.16|<0.05
71734558|NCT01754493|142984010|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.47|||<|0.05|TWO_SIDED|95.0|-1.07|2.01|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis||2.01|-1.07|<0.05
71734559|NCT01754493|142984010|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.59|||<|0.05|TWO_SIDED|95.0|-2.28|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.10|-2.28|<0.05
71734560|NCT01754493|142984010|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.35|||<|0.05|TWO_SIDED|95.0|-1.56|0.87|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||.87|-1.56|<0.05
71761330|NCT01500720|143024142|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.169|||<|0.0001|TWO_SIDED|95.0|1.563|3.01||P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.|Stratified Two-Sided Log-Rank Test||Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.|||3.01|1.563|<0.0001
71832176|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Unaided)||||0.038
71832177|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Unaided)||||0.53
71832178|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Benefit)||||0.63
71832179|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Benefit)||||0.83
71832180|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Benefit)||||0.71
71832181|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Benefit)||||0.16
71832182|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Benefit)||||0.81
71832183|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Aided)||||0.51
71832184|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Aided)||||0.47
71773186|NCT00395538|143046101|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
71773187|NCT00395538|143046101|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.904||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.904
71773188|NCT00395538|143046102|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
71773189|NCT00395538|143046102|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71773190|NCT00395538|143046102|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.01||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.010
71773191|NCT00395538|143046103|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the year 1 biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71832185|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Aided)||||0.93
71832186|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Aided)||||0.62
71832187|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Aided)||||0.63
71832188|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Unaided)||||0.18
71832189|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Unaided)||||0.76
71832190|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Unaided)||||0.17
71832191|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Unaided)||||0.29
71832192|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Unaided)||||0.40
71832193|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Benefit)||||0.29
71832194|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Benefit)||||0.90
71832195|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Benefit)||||0.24
71832196|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Benefit)||||0.45
71832197|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Benefit)||||0.37
71832198|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Aided)||||0.84
71661257|NCT03233230|142836119|SUPERIORITY||Response rate difference|0.07||||0.2202|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2202
71773192|NCT00395538|143046103|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71773193|NCT00395538|143046103|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
71773194|NCT00395538|143046104|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
71773195|NCT00395538|143046104|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.022
71734561|NCT01754493|142984010|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.48|||<|0.05|TWO_SIDED|95.0|-2.0|1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||1.03|-2.00|<0.05
71734562|NCT01754493|142984011|SUPERIORITY_OR_OTHER_LEGACY||Slope|-4.38|||<|0.05|TWO_SIDED|95.0|-7.39|-1.36|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.||-1.36|-7.39|<0.05
71734563|NCT03464019|142984012|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.1212|TWO_SIDED|95.0|0.726|1.623|||Peto-Peto test|||In Part 1, participants who converted following medical assistance were censored at the time of conversion after medical assistance. Participants who presented missing data from time t to the end were censored at the time of last available data. Participants who did not convert or were not censored before 5 hours were censored at 5 hours.||1.623|0.726|0.1212
71734564|NCT03464019|142984012|SUPERIORITY||Hazard Ratio (HR)|2.857|||<|0.001|TWO_SIDED|95.0|1.868|4.371||The threshold for statistical significance was p \< 0.05.|Wilcoxon|||In Parts 2 and 3, participants converting after additional medication interventions were censored after the end of the observation period.||4.371|1.868|<0.001
71773196|NCT00395538|143046104|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.228||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.228
71832199|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Aided)||||0.57
71832200|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Aided)||||0.71
71832201|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Aided)||||0.99
71832202|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Aided)||||0.78
71661258|NCT03233230|142836119|SUPERIORITY||Response rate difference|0.07||||0.2328|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel|||||0.19|-0.05|0.2328
71734565|NCT00511134|142984013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Descriptive data|||It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.||||<0.05
71659665|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores||14.67|-1.38|0.105
71659666|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|15.23|||<|0.001|TWO_SIDED|95.0|6.48|23.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||23.97|6.48|<0.001
71734566|NCT00511134|142984014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Fisher Exact|Degrees of freedom=1||It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.||||<0.05
71734567|NCT01543776|142984052|NON_INFERIORITY|The above criteria for non-inferiority corresponds to a response rate in the low dose arm that is no more than 15% lower than the response rate in the high dose arm (i.e., non-inferiority margin of 15%), under the assumption that the log ratios are approximately normally distributed.|Mean Difference (Final Values)|0.3976|||<|0.1|ONE_SIDED|90.0|-0.1111|||Calculated p-value.|t-test, 1 sided||||||-0.1111|<0.10
71734568|NCT01543776|142984053|SUPERIORITY|||||||0.38|||||||Log Rank|||||||0.38
71734569|NCT01543776|142984054|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71773197|NCT00395538|143046105|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
71773198|NCT00395538|143046105|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.006
71773199|NCT00395538|143046105|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.67||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.670
71832203|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Unaided)||||0.50
71659667|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001||95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71659668|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.61|||<|0.001|TWO_SIDED|95.0|30.15|57.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||57.07|30.15|<0.001
71734570|NCT01543776|142984055|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
71734571|NCT01543776|142984056|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71734572|NCT03055013|142984063|SUPERIORITY||Cox Proportional Hazard|0.95||||0.34|TWO_SIDED|95.0|0.74|1.22|||Log Rank|stratified logrank test (one-sided)|hazard ratio : arm A vs. arm B|||1.22|0.74|0.34
71734573|NCT00528801|142984075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.07||0.008||95.0|||||Mixed Models Analysis|Adjusted for gender, age, and education.|Cases are lower than controls.|Null hypothesis is no difference between cases and controls in the WAIS-III Perormance IQ (PIQ) Index. A linear model controlling for gender, age, and education was used to compare controls versus cases using an F statistic. Based on sample-size calculations, 120 patients and 36 controls were needed to have 80% power to detect an 8-point difference on the WAIS-III PIQ Index.||||0.008
71734574|NCT00528801|142984076|SUPERIORITY_OR_OTHER||Difference in proportions|0.11||||0.048||95.0|0.026|0.199|||Fisher Exact|||Null hypothesis is no difference between cases and controls in the proportion of subjects with lacunae. This was tested using a Fisher's Exact Test.||.199|.026|0.048
71734575|NCT00344500|142984078|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Predicted trajectory of mean weight change between matched UC and LB subjects over 12 months (treatment\*time interaction: F(1,1275)=68.75, p\<.01).||General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.||||<0.01
71832204|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Unaided)||||0.48
71832205|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Unaided)||||0.64
71734576|NCT02207491|142984081|NON_INFERIORITY|Clinical noninferiority was to be concluded if the upper limit of the 95% CIs around the difference (AR-13324 - timolol) was within 1.5 mmHg at all time points and was within 1.0 mmHg at a majority of the time points.|||||<|0.0001||||||Calculated p-value|ANCOVA|Statistical analysis applies at all 3 timepoints on Day 15, Day 43, and Day 90||Assuming zero difference between AR-13324 and timolol, a 2-tailed alpha of 0.05 at each of 9 time points, a common SD of 3.0 mmHg, and a correlation between time points of 0.60 or less, 170 PP subjects per arm were necessary to have 90% power to show clinical noninferiority of AR-13324 to timolol in mean IOP.||||<0.0001
71734577|NCT00126776|142984088|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mean cumulative frequency|||primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P\<0.001)||||< 0.001
71773200|NCT00395538|143046106|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MAR values for both their baseline and year 1 biopsies.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
71773201|NCT00395538|143046106|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71773202|NCT00395538|143046106|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.712||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.712
71832206|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Unaided)||||0.041
71832207|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Unaided)||||0.89
71832208|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Benefit)||||0.14
71832209|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Benefit)||||0.48
71832210|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Benefit)||||0.23
71832211|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Benefit)||||0.57
71832212|NCT01796236|143168568|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Benefit)||||0.21
71832213|NCT01796236|143168569|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Sound Processor Usage: Week 6||||0.46
71889469|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-28.1|||<|0.001|TWO_SIDED|95.0|-41.0|-15.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.1|-41.0|<0.001
71832214|NCT01796236|143168569|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 12||||0.75
71832215|NCT01796236|143168569|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 24||||0.83
71734578|NCT00599755|142984089|SUPERIORITY_OR_OTHER||Proportion|0.4|||||TWO_SIDED|80.0|0.27|0.55||||||||0.55|0.27|
71734579|NCT00599755|142984090|SUPERIORITY_OR_OTHER||Concordance correlation coefficient|0.88|||||TWO_SIDED|80.0|0.85|0.92||||||||0.92|0.85|
71832216|NCT01796236|143168569|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 12||||0.52
71734580|NCT00599755|142984094|SUPERIORITY_OR_OTHER||Proportion|0.125|||||TWO_SIDED|80.0|0.06|0.23||||||||0.23|0.06|
71734581|NCT02893917|142984099|SUPERIORITY||Hazard Ratio (HR)|0.617||||0.0359|TWO_SIDED|95.0|0.392|0.969|||Regression, Cox|||||0.969|0.392|0.0359
71734582|NCT02893917|142984100|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.705|2.399||no p value provided|Regression, Cox|||||2.399|0.705|
71734583|NCT02893917|142984103|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.272|1.504|||Regression, Cox|||HRD positive ONLY||1.504|0.272|
71832217|NCT01796236|143168569|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 24||||0.67
71832218|NCT01796236|143168569|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 36||||0.71
71832219|NCT01796236|143168571|SUPERIORITY_OR_OTHER|||||||0.91|||||||Mantel Haenszel|||Baseline: Smoking and Wet Snuff habits||||0.91
71734584|NCT02893917|142984103|OTHER||Hazard Ratio (HR)|0.777|||||TWO_SIDED|95.0|0.448|1.348|||Regression, Cox|||HRD negative ONLY||1.348|0.448|
71734585|NCT03626545|142984109|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.633|TWO_SIDED|95.0|0.76|1.48|||Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards regression model stratified by line of therapy and histology|||1.48|0.76|0.633
71734586|NCT01939366|142984134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.37||0.0621|TWO_SIDED|95.0|-1.43|0.04||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.04|-1.43|0.0621
71734587|NCT01939366|142984134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.39||0.0564|TWO_SIDED|95.0|-1.5|0.02||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||0.02|-1.50|0.0564
71734588|NCT01939366|142984134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.41||0.0153|TWO_SIDED|95.0|-1.83|-0.2||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.||-0.20|-1.83|0.0153
71734589|NCT00680797|142984135|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED|||||Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.023
71734590|NCT00680797|142984135|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Comparison in the change in insulin levels between the groups receiving E with or without T.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.||||0.042
71734591|NCT02596230|142984149|OTHER||Hazard Ratio (HR)|0.634||||0.188|TWO_SIDED|95.0|0.322|1.249||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.249|0.322|0.188
71734592|NCT02596230|142984150|OTHER||Hazard Ratio (HR)|0.778||||0.606|TWO_SIDED|95.0|0.3|2.017||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||2.017|0.300|0.606
71734593|NCT02596230|142984151|OTHER||Hazard Ratio (HR)|0.751||||0.542|TWO_SIDED|95.0|0.299|1.885||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.885|0.299|0.542
71832220|NCT01796236|143168571|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mantel Haenszel|||Week 3: Smoking and Wet Snuff habits||||0.70
71832221|NCT01796236|143168571|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mantel Haenszel|||Week 12: Smoking and Wet Snuff habits||||0.95
71734594|NCT02596230|142984152|OTHER||Hazard Ratio (HR)|0.0||||0.996|TWO_SIDED|95.0||||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|"Hazard Ratio \< 1 favors Dabigatran etexilate.~Hazard Ratio is actually \<0.01~95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events."|||||0.996
71734595|NCT02596230|142984153|OTHER||Hazard Ratio (HR)|0.857||||0.69|TWO_SIDED|95.0|0.402|1.828||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio \< 1 favors Dabigatran etexilate.|||1.828|0.402|0.690
71761331|NCT00806819|143024148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0435|TWO_SIDED|95.0|0.7|0.99|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||0.99|0.70|0.0435
71832222|NCT01796236|143168571|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mantel Haenszel|||Month 12: Smoking and Wet Snuff habits||||0.22
71832223|NCT01796236|143168571|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mantel Haenszel|||Month 24: Smoking and Wet Snuff habits||||0.19
71832224|NCT01796236|143168571|SUPERIORITY_OR_OTHER|||||||0.45|||||||Mantel Haenszel|||Month 36: Smoking and Wet Snuff habits||||0.45
71832225|NCT01796236|143168572|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.989|TWO_SIDED|95.0|||||Log Rank|||Loss of Implant (safety population)||||0.989
71832226|NCT00546754|143168574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.153||95.0|||||ANOVA|||||||0.153
71832227|NCT00546754|143168575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343||95.0|||||ANOVA|||||||0.343
71832228|NCT00546754|143168576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
71832229|NCT00546754|143168577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395||95.0|||||ANOVA|||||||0.395
71832230|NCT00546754|143168578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.662||95.0|||||Fisher Exact|||||||0.662
71734596|NCT03446456|142984170|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in changes of BOLD signal in the brain.|Mean Difference (Final Values)|0.00264||||0.982|TWO_SIDED|||||Bonferroni corrected|t-test, 2 sided|||Percentage of BOLD signal change was calculated as the BOLD signal in the right supplementary motor area (SMA, a typical brain area responding to pain stimulation), divided by the BOLD signal of the whole-brain average during the 24 trials of 20-second painful stimulations. The percentage of BOLD signal changes in SMA during the 20-second painful stimulations were compared between the Saline group and the Vasopressin group using an equivalence test.||||0.982
71734597|NCT03446456|142984171|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in heating temperature that was used for the testing phase.|Mean Difference (Final Values)|-0.282||||0.269|TWO_SIDED|||||Bonferroni corrected|ANCOVA|The drug group (Vasopressin vs. Saline) was set as a between-subject factor. Age and race were treated as covariates.||||||0.269
71734598|NCT03446456|142984172|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in implicit racial biases.|Mean Difference (Final Values)|-0.04||||0.378|TWO_SIDED||||||ANCOVA|Drug group (Vasopressin vs. Saline) was set as between-subject factor. Age and race were treated as covariates.||"Response latencies were recorded to calculate the IAT difference score (D). A difference score (D) was calculated based on the following steps: 1) Compute the standard deviation (SD) of response latencies from overall trials; 2) M1 is the mean of the response latencies in the condition where White people and good share the same response key. M2 is the mean of the latencies in the condition where African-American/Asian people and good share the same response key; 3) D = (M2-M1)/SD."||||0.378
71734599|NCT03446456|142984173|EQUIVALENCE|An equivalence test was conducted to compare if the vasopressin group differed from the saline group in self-reported pain intensity ratings.|Mean Difference (Final Values)|-2.35||||0.014|TWO_SIDED|||||Bonferroni corrected|Mixed Models Analysis|Age, race, and heating temperature used during the testing phase were treated as covariates.||||||0.014
71734600|NCT04099511|142984180|SUPERIORITY|||||||0.693|||||||Wilcoxon (Mann-Whitney)|||||||.693
71734601|NCT04099511|142984181|SUPERIORITY|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||.536
71734602|NCT04099511|142984182|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||.260
71734603|NCT04099511|142984183|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||||||.387
71734604|NCT04099511|142984184|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
71734605|NCT04099511|142984185|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
71734606|NCT04099511|142984186|SUPERIORITY|||||||0.388|||||||Wilcoxon (Mann-Whitney)|||||||0.388
71734607|NCT04099511|142984187|SUPERIORITY|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
71773203|NCT00395538|143046107|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.OS/BS values for both their baseline and year 1 biopsies.||||||0.029||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.029
71773204|NCT00395538|143046107|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71773205|NCT00395538|143046107|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.104||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.104
71832231|NCT00546754|143168579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Log Rank|||||||0.020
71832232|NCT00546754|143168580|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71832233|NCT00546754|143168581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||ANOVA|||||||0.935
71832234|NCT00546754|143168582|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71832235|NCT00546754|143168583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.899||95.0|||||ANOVA|||||||0.899
71832236|NCT00546754|143168584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||ANOVA|||||||0.218
71832237|NCT00546754|143168585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0|||||ANOVA|||||||0.386
71832238|NCT00546754|143168586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725||95.0|||||ANOVA|||||||0.725
71832239|NCT03830866|143168594|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.174|TWO_SIDED|95.0|0.65|1.08|||Log Rank|||||1.08|0.65|0.174
71832240|NCT03830866|143168595|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.203|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||||1.10|0.64|0.203
71832241|NCT03830866|143168597|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.091|TWO_SIDED|95.0|0.6|1.04|||Log Rank|||||1.04|0.60|0.091
71832242|NCT03830866|143168598|SUPERIORITY||Odds Ratio (OR)|1.15||||0.465|TWO_SIDED|95.0|0.794|1.657|||Regression, Logistic|||||1.657|0.794|0.465
71734608|NCT03002311|142984207|SUPERIORITY|We conducted a conditional power analysis 120 days after 6 months of enrollment. We determined the effect size based on the difference of proportions of follow-up attendance in the intervention and control arms. We used the effect size of 20% to estimate the sample size needed for a two-sided alpha of 0.05 at 90% power and a 1:1 ratio to require 266 participants. Loss to follow-up was estimated to be 20%, increasing target enrollment to 334 total participants.|||||<|0.001|||||||Gray's test|We compared the cumulative incidence function.||||||<0.001
71734609|NCT03002311|142984208|SUPERIORITY|This was a secondary analysis so no power analysis was done.||||||0.8||||||We used a two-sided alpha of 0.05 to determine significance.|Gray's test|We compared the cumulative incidence functions.||||||0.8
71734610|NCT06225466|142984224|SUPERIORITY||least squares mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.123|TWO_SIDED|95.0|-0.005|0.047|||ANOVA|||||0.047|-0.005|0.123
71734611|NCT06225466|142984225|SUPERIORITY||Odds Ratio (OR)|0.55||||0.102|TWO_SIDED|95.0|0.26|1.12|||Mixed Models Analysis|||||1.12|0.26|0.102
71734612|NCT06225466|142984226|SUPERIORITY||Incidence rate ratio|2.37||||0.008|TWO_SIDED|95.0|1.25|4.52|||Negative Binomial Regression|||||4.52|1.25|0.008
71734613|NCT00997620|142984385|OTHER||Mean Difference (Net)|0.5|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.||||< .05
71734614|NCT00300365|142984403|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71734615|NCT01818492|142984410|SUPERIORITY|||||||0.0134|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0134
71734616|NCT01818492|142984411|SUPERIORITY|||||||0.0031|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0031
71734617|NCT01818492|142984412|SUPERIORITY|||||||0.0205|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%||||0.0205
71734618|NCT01818492|142984413|SUPERIORITY|||||||0.0053|||||||Exact binomial test|This test was undertaken at the one-sided 0.025 significance level.||Pre-specified null hypothesis that ORR is at most 40%.||||0.0053
71734619|NCT01972789|142984443|NON_INFERIORITY|This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group|Odds Ratio (OR)|0.4||||0.787|TWO_SIDED|95.0|-2.51|3.32|||Mixed Models Analysis|||||3.32|-2.51|0.787
71734620|NCT01972789|142984444|OTHER||Odds Ratio (OR)|-0.31||||0.833|TWO_SIDED|95.0|-3.2|2.58|||Mixed Models Analysis|||||2.58|-3.20|0.833
71734621|NCT01972789|142984445|OTHER||Odds Ratio (OR)|-21.39||||0.054|TWO_SIDED|95.0|-43.17|0.39|||Mixed Models Analysis|||||0.39|-43.17|0.054
71775096|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.82|TWO_SIDED|95.0|-1.02|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-1.02|0.82
71734622|NCT01972789|142984446|OTHER||Negative Binomial Regression|1.11||||0.001|TWO_SIDED|95.0|1.04|1.18|||Mixed Model|||||1.18|1.04|0.001
71734623|NCT01972789|142984447|OTHER||Odds Ratio (OR)|0.26||||0.338|TWO_SIDED|95.0|-0.28|0.8|||Mixed Models Analysis|||||0.80|-0.28|0.338
71734624|NCT01972789|142984448|OTHER||Odds Ratio (OR)|1.44||||0.284|TWO_SIDED|95.0|0.74|2.8|||Regression, Logistic|||Month 12||2.80|0.74|0.284
71734625|NCT01972789|142984448|OTHER||Odds Ratio (OR)|1.29||||0.407|TWO_SIDED|95.0|0.71|2.33|||Regression, Logistic|||Month 24||2.33|0.71|0.407
71734626|NCT01972789|142984449|OTHER||Odds Ratio (OR)|0.35||||0.217|TWO_SIDED|95.0|0.12|1.04|||Regression, Logistic|||||1.04|0.12|0.217
71734627|NCT01972789|142984450|OTHER||Odds Ratio (OR)|0.84||||0.615|TWO_SIDED|95.0|0.42|1.66|||Regression, Logistic|||||1.66|0.42|0.615
71734628|NCT01972789|142984451|OTHER||Odds Ratio (OR)|1.08||||0.819|TWO_SIDED|95.0|0.54|2.18|||Regression, Logistic|||||2.18|0.54|0.819
71734629|NCT01972789|142984453|OTHER||Odds Ratio (OR)|4.32||||0.565|TWO_SIDED|95.0|0.03|630.5|||Regression, Logistic|||||630.5|0.03|0.565
71734630|NCT01972789|142984454|OTHER||Odds Ratio (OR)|1.39||||0.034|TWO_SIDED|95.0|1.03|1.9|||Regression, Logistic|||||1.90|1.03|0.034
71734631|NCT04407234|142984459|SUPERIORITY||Ratio of geometric least squares mean|0.881|||||TWO_SIDED|90.0|0.803|0.967|||Wilcoxon signed rank test|||||0.967|0.803|
71734632|NCT04407234|142984459|SUPERIORITY||Ratio of geometric least squares mean|1.16|||||TWO_SIDED|90.0|1.05|1.28|||Wilcoxon signed rank test|||||1.28|1.05|
71734633|NCT04407234|142984460|SUPERIORITY||Ratio of geometric least squares mean|0.446|||||TWO_SIDED|90.0|0.39|0.509|||Wilcoxon signed rank test|||||0.509|0.390|
71734634|NCT04407234|142984460|SUPERIORITY||Ratio of geometric least squares mean|0.679|||||TWO_SIDED|90.0|0.589|0.783|||Wilcoxon signed rank test|||||0.783|0.589|
71734635|NCT04407234|142984462|SUPERIORITY||Ratio of geometricleast squares mean|0.888|||||TWO_SIDED|90.0|0.778|1.01||||||||1.01|0.778|
71734636|NCT04407234|142984462|SUPERIORITY||Ratio of geometricleast squares mean|1.23|||||TWO_SIDED|90.0|1.07|1.42||||||||1.42|1.07|
71734637|NCT04407234|142984463|SUPERIORITY||Ratio of geometricleast squares mean|0.875|||||TWO_SIDED|90.0|0.766|0.999||||||||0.999|0.766|
71734638|NCT04407234|142984463|SUPERIORITY||Ratio of geometricleast squares mean|1.08|||||TWO_SIDED|90.0|0.938|1.25||||||||1.25|0.938|
71734639|NCT04407234|142984464|SUPERIORITY||Ratio of geometricleast squares mean|0.453|||||TWO_SIDED|90.0|0.376|0.545||||||||0.545|0.376|
71734640|NCT04407234|142984464|SUPERIORITY||Ratio of geometricleast squares mean|0.804|||||TWO_SIDED|90.0|0.66|0.979||||||||0.979|0.660|
71734641|NCT04407234|142984465|SUPERIORITY||Ratio of geometricleast squares mean|0.438|||||TWO_SIDED|90.0|0.364|0.527||||||||0.527|0.364|
71734642|NCT04407234|142984465|SUPERIORITY||Ratio of geometricleast squares mean|0.574|||||TWO_SIDED|90.0|0.471|0.698||||||||0.698|0.471|
71659669|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|8.61||||0.065|TWO_SIDED|95.0|-0.55|17.76|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||17.76|-0.55|0.065
71734643|NCT00727558|142984468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.554|STANDARD_ERROR_OF_MEAN|0.1943||||97.47|0.1721|0.554|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.554|0.1721|
71734644|NCT00727558|142984469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1734|STANDARD_ERROR_OF_MEAN|0.03555||||97.47|-0.1734|-0.1037|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||-0.1037|-0.1734|
71734645|NCT00727558|142984470|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3968|STANDARD_ERROR_OF_MEAN|0.1548||||98.7|0.04983|0.3968|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.3968|0.04983|
71734646|NCT00727558|142984471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3875|STANDARD_ERROR_OF_MEAN|0.2054||||98.7|0.03714|0.3875|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A.||0.3875|0.03714|
71734647|NCT00727558|142984472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6735|STANDARD_ERROR_OF_MEAN|0.1563||||98.7|0.213|0.6735|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.6735|0.213|
71734648|NCT00727558|142984473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.1648||||98.7|-0.2375|0.132|||Mixed Models Analysis||Mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A||0.132|-0.2375|
71734649|NCT00727558|142984474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2469|STANDARD_ERROR_OF_MEAN|0.04448||||97.47|-0.2469|-0.1599|||Mixed Models Analysis||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining||-0.1599|-0.2469|
71734650|NCT03268941|142984489|OTHER||Least Square (LS) Mean Difference|7.38|||<|0.001|TWO_SIDED|95.0|4.03|13.52||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||13.52|4.03|<0.001
71773206|NCT00395538|143046108|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.ES/BS values for both their baseline and year 1 biopsies.||||||0.088||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.088
71661259|NCT03233230|142836120|SUPERIORITY||Response rate difference|0.06||||0.1232|TWO_SIDED|95.0|-0.02|0.15|||Cochran-Mantel-Haenszel|||||0.15|-0.02|0.1232
71734651|NCT03268941|142984489|OTHER||LS Mean Difference|11.24|||<|0.001|TWO_SIDED|95.0|5.91|21.41||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||21.41|5.91|<0.001
71734652|NCT03268941|142984489|OTHER||LS Mean Difference|12.8|||<|0.001|TWO_SIDED|95.0|6.94|23.59||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.||23.59|6.94|<0.001
71734653|NCT03268941|142984490|OTHER||LS Mean Difference|7.76|STANDARD_ERROR_OF_MEAN|14.648||0.599|TWO_SIDED|95.0|-21.89|37.41||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.41|-21.89|0.599
71734654|NCT03268941|142984490|OTHER||LS Mean Difference|6.28|STANDARD_ERROR_OF_MEAN|15.469||0.687|TWO_SIDED|95.0|-25.04|37.59||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||37.59|-25.04|0.687
71734655|NCT03268941|142984490|OTHER||LS Mean Difference|8.05|STANDARD_ERROR_OF_MEAN|15.45||0.605|TWO_SIDED|95.0|-23.22|39.33||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.||39.33|-23.22|0.605
71773207|NCT00395538|143046108|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.009
71832243|NCT03830866|143168599|SUPERIORITY||Odds Ratio (OR)|1.11||||0.469|TWO_SIDED|95.0|0.833|1.487|||Regression, Logistic|||||1.487|0.833|0.469
71734656|NCT03268941|142984491|OTHER||LS Mean Difference|7.56|STANDARD_ERROR_OF_MEAN|11.708||0.522|TWO_SIDED|95.0|-16.06|31.19||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||31.19|-16.06|0.522
71734657|NCT03268941|142984491|OTHER||LS Mean Difference|12.92|STANDARD_ERROR_OF_MEAN|12.143||0.293|TWO_SIDED|95.0|-11.58|37.43||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||37.43|-11.58|0.293
71773208|NCT00395538|143046108|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.325||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.325
71773209|NCT00395538|143046109|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 3 participants with non-missing Ec.AjAR values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71773210|NCT00395538|143046109|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71832244|NCT00311363|143168601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.353||||0.0158||95.0|0.2|0.8||Model included terms for treatment group, randomization IRLS score (Week 24), and pooled study site|Regression, Logistic|||||0.8|0.2|0.0158
71832245|NCT05113771|143168652|SUPERIORITY||LS Mean Difference|-4.4||||0.0056|TWO_SIDED|95.0|-7.6|-1.3|||MMRM|mixed model for repeated measures (MMRM) with imputation based on the missing at random (MAR) assumption was used.||||-1.3|-7.6|0.0056
71832246|NCT05113771|143168653|SUPERIORITY|||||||0.0189|||||||MMRM|||||||0.0189
71832247|NCT05113771|143168654|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||||||0.0026
71832248|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-4.98|2.54||||||SBP||2.54|-4.98|
71832249|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-4.7|2.53||||||SBP||2.53|-4.70|
71832250|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-1.54|||||TWO_SIDED|90.0|-5.3|2.22||||||SBP||2.22|-5.30|
71832251|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-1.53|||||TWO_SIDED|90.0|-5.16|2.1||||||SBP||2.10|-5.16|
71832252|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-3.84|||||TWO_SIDED|90.0|-7.74|0.07||||||SBP||0.07|-7.74|
71832253|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-0.38|||||TWO_SIDED|90.0|-2.95|2.18||||||DBP||2.18|-2.95|
71832254|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-3.69|1.48||||||DBP||1.48|-3.69|
71832255|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|90.0|-3.75|1.85||||||DBP||1.85|-3.75|
71832256|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|90.0|-4.09|1.1||||||DBP||1.10|-4.09|
71832257|NCT01849055|143168696|SUPERIORITY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|90.0|-5.23|0.2||||||DBP||0.20|-5.23|
71832258|NCT03122886|143168788|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.9|TWO_SIDED|95.0|0.12|6.37|||Log Rank|||||6.37|0.12|0.90
71832259|NCT03422276|143168789|SUPERIORITY||Mean Difference (Net)|-0.78||||0.44|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|t-test for independent samples, two-tailed, allocation ratio=1|Intervention mean minus control mean|It was calculated that 500 to 900 participants randomized in a 1:1 fashion between the two arms would have practically 100% power to detect an effect size of 0.5, and even a small sample size of 300 would have 80% power to detect a small effect size of 0.3 (800 to 900 would be 100% power).||||0.44
71832260|NCT03422276|143168790|SUPERIORITY||Mean Difference (Net)|1.63||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||0.10
71832261|NCT05938413|143168854|NON_INFERIORITY|Non-inferiority test to compare viral suppression rate between month 3 and baseline.|Odds Ratio (OR)|3.01|||||TWO_SIDED|||||||||||||
71832262|NCT03312907|143168874|OTHER||Odds Ratio (OR)|1.27||||0.5342|TWO_SIDED|95.0|0.6|2.71|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose. Belimumab + Standard therapy arm was excluded from model.|||2.71|0.60|0.5342
71734658|NCT03268941|142984491|OTHER||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|11.654||0.551|TWO_SIDED|95.0|-16.52|30.52||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.||30.52|-16.52|0.551
71773211|NCT00395538|143046109|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.974||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.974
71773212|NCT00395538|143046110|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.004
71773213|NCT00395538|143046110|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.023||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.023
71734659|NCT03268941|142984492|OTHER||Hodges-Lehmann Estimate of Median Diff|-18.14||||0.274|TWO_SIDED|95.0|-307.58|13.56||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||13.56|-307.58|0.274
71734660|NCT03268941|142984492|OTHER||Hodges-Lehmann Estimate of Median Diff|-26.95||||0.481|TWO_SIDED|95.0|-229.73|530.49||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.||530.49|-229.73|0.481
71734661|NCT03268941|142984492|OTHER||Hodges-Lehmann Estimate of Median Diff|-24.49||||0.382|TWO_SIDED|95.0|-225.87|98.91||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.||98.91|-225.87|0.382
71832263|NCT03312907|143168874|OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.32|1.54|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, and Baseline prednisone equivalent dose. Belimumab + Placebo arm excluded from model.|||1.54|0.32|
71832264|NCT03312907|143168875|OTHER||Odds Ratio (OR)|1.12||||0.8582|TWO_SIDED|95.0|0.33|3.78|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||3.78|0.33|0.8582
71832265|NCT03312907|143168875|OTHER||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.17|1.7|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from model.|||1.70|0.17|
71832266|NCT03312907|143168876|OTHER||Odds Ratio (OR)|1.64||||0.3613|TWO_SIDED|95.0|0.57|4.72|||Regression, Logistic||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||4.72|0.57|0.3613
71734662|NCT01216683|142984497|SUPERIORITY|||||||0.02||||||one-sided p-value|Cochran-Mantel-Haenszel|||The study was designed to detect a 16% difference in CR rate from 50% in the Bendamustine + Rituximab arms to 66% in the Bendamustine + Rituximab + Bortezomib arm, with 90% power at the one-sided alpha 0.15 level.||||0.02
71734663|NCT01216683|142984498|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified on Groupe d'Etude des Lymphomes Folliculaires status and Follicular Lymphoma International Prognostic Index||||||0.02
71734664|NCT02702180|142984566|SUPERIORITY||Least Square Means (LSmean)|-4.6||||0.1688|TWO_SIDED|95.0|-11.1|2.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|Primary endpoint was evaluated using analysis of covariance with treatment, whole lung lavage within 2 months before baseline, and geographic region as factors, and baseline values as covariates. To control type I error, key secondary endpoints were analyzed using a testing hierarchy wherein once daily molgramostim and placebo was compared and if statistical significance was reached, evaluation of intermittent molgramostim and placebo would proceed.||2.0|-11.1|0.1688
71734665|NCT02702180|142984566|SUPERIORITY||Least Square Means (LSmean)|-2.8||||0.3968|TWO_SIDED|95.0|-9.3|3.7|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||3.7|-9.3|0.3968
71734666|NCT02702180|142984567|SUPERIORITY||Least Square Means (LSmean)|20.6||||0.3159|TWO_SIDED|95.0|-19.8|61.0|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||61.0|-19.8|0.3159
71734667|NCT02702180|142984567|SUPERIORITY||Least Square Means (LSmean)|5.6||||0.7809|TWO_SIDED|95.0|-34.1|45.2|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24.|||45.2|-34.1|0.7809
71832267|NCT03312907|143168876|OTHER||Odds Ratio (OR)|0.45|||||TWO_SIDED|95.0|0.19|1.09|||||Odds ratio was calculated using logistic regression model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.09|0.19|
71832268|NCT03312907|143168882|OTHER||Hazard Ratio (HR)|0.81||||0.215|TWO_SIDED|95.0|0.57|1.13|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.13|0.57|0.2150
71661260|NCT03233230|142836120|SUPERIORITY||Response rate difference|0.05||||0.1725|TWO_SIDED|95.0|-0.03|0.14|||Cochran-Mantel-Haenszel|||||0.14|-0.03|0.1725
71734668|NCT02702180|142984568|SUPERIORITY||Least Square Means (LSmean)|-7.6||||0.0103|TWO_SIDED|95.0|-13.4|-1.8|||ANCOVA||The estimated value represents the estimated difference between once daily molgramostim and placebo groups in LSmean change from baseline to week 24.|||-1.8|-13.4|0.0103
71734669|NCT02702180|142984568|SUPERIORITY||Least Square Means (LSmean)|-7.0||||0.0173|TWO_SIDED|95.0|-12.7|-1.3|||ANCOVA||The estimated value represents the estimated difference between intermittent molgramostim and placebo groups in LSmean change from baseline to week 24..|||-1.3|-12.7|0.0173
71734670|NCT02702180|142984569|SUPERIORITY||Risk Ratio (RR)|0.284||||0.1918|TWO_SIDED|95.0|0.043|1.881|||Negative binomial regression||The estimated value represents the RR between once daily molgramostim and placebo groups.|||1.881|0.043|0.1918
71734671|NCT02702180|142984569|SUPERIORITY||Risk Ratio (RR)|0.367||||0.2421|TWO_SIDED|95.0|0.068|1.968|||Negative binomial regression||The estimated value represents the RR between intermittent molgramostim and placebo groups.|||1.968|0.068|0.2421
71734672|NCT03270891|142984597|SUPERIORITY|Null hypothesis of equality.||||||0.0115|||||||t-test, 2 sided|||Baseline and 6 month values||||0.0115
71734673|NCT03270891|142984597|SUPERIORITY|Null hypothesis of equality.||||||0.027|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.027
71734674|NCT03270891|142984598|SUPERIORITY|Null hypothesis of equality.||||||0.0327|||||||t-test, 2 sided|||Baseline p value to six month||||0.0327
71734675|NCT03270891|142984598|SUPERIORITY|Null hypothesis of equality.||||||0.2088|||||||t-test, 2 sided|||baseline to 6 month comparison p value||||0.2088
71734676|NCT03270891|142984599|SUPERIORITY|Null hypothesis of equality.||||||0.947|||||||t-test, 2 sided|||baseline to 6 month comparison||||0.947
71734677|NCT01716104|142984622|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71734678|NCT01716104|142984623|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71734679|NCT01716104|142984624|SUPERIORITY|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
71734680|NCT01716104|142984625|SUPERIORITY|||||||0.0011|||||||Mixed Models Analysis|||||||0.0011
71734681|NCT01716104|142984626|SUPERIORITY|||||||0.0054|||||||Mixed Models Analysis|||||||0.0054
71734682|NCT01716104|142984627|SUPERIORITY|||||||0.0437|||||||Mixed Models Analysis|||||||0.0437
71734683|NCT01716104|142984628|SUPERIORITY|||||||0.0862|||||||Mixed Models Analysis|||||||0.0862
71734684|NCT01716104|142984629|SUPERIORITY|||||||0.0621|||||||Mixed Models Analysis|||||||0.0621
71734685|NCT01716104|142984630|SUPERIORITY|||||||0.0142|||||||Mixed Models Analysis|||||||0.0142
71734686|NCT02522442|142984632|OTHER|Pilot study, not powered for any endpoint.||||||0.377|||||||Chi-squared|||Pilot study, not powered for any endpoint.||||0.377
71734687|NCT02522442|142984633|OTHER|Pilot study, not powered for any endpoint.||||||0.624|||||||Chi-squared|||||||.624
71734688|NCT03836677|142984686|OTHER||Geometric Mean ratio to baseline|1.72|||<|0.0001|TWO_SIDED|95.0|1.38|2.13||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||2.13|1.38|<0.0001
71734689|NCT03836677|142984686|OTHER||Geometric mean ratio to baseline|1.53|||<|0.0001|TWO_SIDED|95.0|1.28|1.83||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test.||||1.83|1.28|<0.0001
71734690|NCT03836677|142984687|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.63||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.39|<0.0001
71734691|NCT03836677|142984687|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment.|t-test, 2 sided|Within-group comparison to baseline using paired test||||0.67|0.40|<0.0001
71734692|NCT03836677|142984688|OTHER||Geometric mean ratio to baseline|1.7|||<|0.0001||95.0|1.37|2.11|||t-test, 2 sided|Within-group comparison to baseline using paired test||||2.11|1.37|<0.0001
71734693|NCT03836677|142984688|OTHER||Geometric mean ratio to baseline|1.51||||0.0001|TWO_SIDED|95.0|1.26|1.8|||t-test, 2 sided|Within-group comparison to baseline using paired test||||1.80|1.26|0.0001
71734694|NCT03836677|142984689|OTHER||Geometric mean ratio to baseline|0.5|||<|0.0001|TWO_SIDED|95.0|0.4|0.63|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.63|0.40|<0.0001
71734695|NCT03836677|142984689|OTHER||Geometric mean ratio to baseline|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||t-test, 2 sided|Within-group comparison to baseline using paired test||||0.68|0.40|<0.0001
71734696|NCT03836677|142984690|OTHER||Mean Change from Baseline|0.346||||0.0003|TWO_SIDED|95.0|0.182|0.509|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.509|0.182|0.0003
71734697|NCT03836677|142984690|OTHER||Mean Change from Baseline|0.273||||0.0004|TWO_SIDED|95.0|0.14|0.405|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.405|0.140|0.0004
71661261|NCT03233230|142836120|SUPERIORITY||Response rate difference|0.05||||0.1795|TWO_SIDED|95.0|-0.03|0.13|||Cochran-Mantel-Haenszel|||||0.13|-0.03|0.1795
71734698|NCT03836677|142984691|OTHER||Mean ratio to baseline|-0.28||||0.2515|TWO_SIDED|95.0|-0.77|0.21|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||0.21|-0.77|0.2515
71734699|NCT03836677|142984691|OTHER||Mean ratio to baseline|-0.5||||0.004|TWO_SIDED|95.0|-0.81|-0.18|||t-test, 2 sided|Within-group comparison to baseline using paired test.||||-0.18|-0.81|0.0040
71832269|NCT03312907|143168882|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|1.03|2.63|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.63|1.03|
71832270|NCT03312907|143168883|OTHER||Hazard Ratio (HR)|0.87||||0.3757|TWO_SIDED|95.0|0.64|1.19|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||1.19|0.64|0.3757
71832271|NCT03312907|143168883|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.71|1.49|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||1.49|0.71|
71734700|NCT00462748|142984719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
71734701|NCT00462748|142984719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Hochberg's FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C \< 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.||||<0.001
71734702|NCT03233438|142984720|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|2.5||0.003|TWO_SIDED|95.0|0.6|2.6|||t-test, 2 sided|||||2.6|0.6|0.003
71734703|NCT03233438|142984721|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|2.56||0.003|TWO_SIDED|95.0|0.6|2.8|||t-test, 2 sided|||||2.8|0.6|0.003
71761332|NCT00806819|143024149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.894|TWO_SIDED|95.0|0.85|1.21|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.21|0.85|0.8940
71761333|NCT00806819|143024150|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0506|TWO_SIDED|95.0|0.7|1.0|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.00|0.70|0.0506
71761334|NCT00806819|143024151|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0865|TWO_SIDED|95.0|0.73|1.02|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.02|0.73|0.0865
71761335|NCT00806819|143024152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.7279|TWO_SIDED|95.0|0.65|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|0.65|0.7279
71761336|NCT00806819|143024152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.518|TWO_SIDED|95.0|0.75|1.76||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||1.76|0.75|0.5180
71761337|NCT00806819|143024155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.0387|TWO_SIDED|95.0|1.02|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||1.85|1.02|0.0387
71761338|NCT00806819|143024155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.1071|TWO_SIDED|95.0|0.95|1.75||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||1.75|0.95|0.1071
71761339|NCT00806819|143024157|SUPERIORITY_OR_OTHER|||||||0.1558|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||0.1558
71761340|NCT00806819|143024157|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||0.0565
71761341|NCT00806819|143024158|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5068|TWO_SIDED|95.0|0.74|1.16|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.16|0.74|0.5068
71761342|NCT00806819|143024159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1181|TWO_SIDED|95.0|0.66|1.05|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||1.05|0.66|0.1181
71832272|NCT03312907|143168884|OTHER||Hazard Ratio (HR)|1.55||||0.5127|TWO_SIDED|95.0|0.42|5.78|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.78|0.42|0.5127
71832273|NCT03312907|143168884|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.23|2.1|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||2.10|0.23|
71832274|NCT03312907|143168885|OTHER||Hazard Ratio (HR)|0.83||||0.8436|TWO_SIDED|95.0|0.14|5.05|||Cox proportional hazards model||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from model.|||5.05|0.14|0.8436
71734704|NCT03429543|142984751|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.33||0.2935|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.30|-0.99|0.2935
71734705|NCT03429543|142984751|OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.33||0.0116|TWO_SIDED|95.0|-1.5|-0.19|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 1 (TG1) consisting of Placebo, Linagliptin 5 mg and Empagliflozin pooled Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.19|-1.50|0.0116
71734706|NCT03429543|142984751|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.4||0.1943|TWO_SIDED|95.0|-1.31|0.27|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 2 (TG2) consisting of Placebo, Empagliflozin 25mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||0.27|-1.31|0.1943
71734707|NCT03429543|142984751|OTHER|Only after having obtained statistically significant results for both hypotheses of the primary family of hypotheses (TG1), the secondary hypotheses were to compare the individual empagliflozin doses versus placebo based on TG2 and TG3.The ANCOVA utilised a weight of zero for patients who were not in the hypothesis test of interest, a value of 2 for re-randomised patients who were in the hypothesis test of interest and a value of 1 otherwise.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.37||0.0015|TWO_SIDED|95.0|-1.9|-0.45|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Treatment group 3 (TG3) consisting of Placebo, Empagliflozin 10mg Patients: Analysis of covariance (ANCOVA) model with a continuous covariate (baseline HbA1c) and categorical covariates (treatment and age). The effect of linagliptin and of empagliflozin (including responders and non-responders) was compared with placebo at an overall α of 0.05 (2-sided) using the Hochberg method to account for multiple testing.||-0.45|-1.90|0.0015
71734708|NCT03429543|142984752|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
71734709|NCT03429543|142984752|OTHER||Risk Difference (RD)|-10.0||||1|TWO_SIDED|90.0|-58.7|43.7|||Fisher Exact||Risk difference calculated as \[treatment\]-\[placebo\].|Risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 90% confidence interval based on the method of Chan and Zhang. Patients were assigned to the treatment they were randomised to at the initial randomisation.||43.7|-58.7|1.0000
71734710|NCT03429543|142984753|OTHER||Adjusted mean difference|-0.68||||0.4828|TWO_SIDED|95.0|-2.86|1.49|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.49|-2.86|0.4828
71761343|NCT00806819|143024159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4264|TWO_SIDED|95.0|0.77|1.12|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.12|0.77|0.4264
71761344|NCT00806819|143024159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.8929|TWO_SIDED|95.0|0.84|1.23|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).||1.23|0.84|0.8929
71761345|NCT04901715|143024194|OTHER|||||||0.002|||||||ANOVA|||||||0.002
71761346|NCT04901715|143024194|OTHER|||||||0.054|||||||ANOVA|||||||0.054
71761347|NCT04901715|143024194|OTHER|||||||0.27|||||||ANOVA|||||||0.27
71761348|NCT04901715|143024195|OTHER|||||||0.014|||||||ANOVA|||||||0.014
71773214|NCT00395538|143046110|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.288||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.288
71773215|NCT00395538|143046111|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MAR values for both their baseline and year 1 biopsies.||||||0.202||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.202
71773216|NCT00395538|143046111|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.486||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.486
71773217|NCT00395538|143046111|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.535||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.535
71889470|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-21.2|||<|0.001|TWO_SIDED|95.0|-33.5|-8.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.8|-33.5|<0.001
71889471|NCT00792298|143300604|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-21.4||||0.001|TWO_SIDED|95.0|-34.2|-8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.7|-34.2|0.001
71661262|NCT03233230|142836128|SUPERIORITY||Response rate difference|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
71773218|NCT00395538|143046112|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.OS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.001
71773219|NCT00395538|143046112|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
71734711|NCT03429543|142984753|OTHER||Adjusted mean difference|-0.38||||0.7047|TWO_SIDED|95.0|-2.64|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Restricted maximum likelihood (REML) approach with mixed model for repeated measures (MMRM). Fixed categorical effects of treatment, visit, and treatment-by-visit interaction and categorical covariate age (baseline) and continuous, fixed covariates of baseline of response variable and baseline of response variable-by-visit interaction. Covariate visit was treated as repeated measure with an unstructured covariance structure used to model within-patient measurements.||1.88|-2.64|0.7047
71734712|NCT03429543|142984754|OTHER|||||||0.8626|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.8626
71734713|NCT03429543|142984754|OTHER|||||||0.2827|||||||Log Rank|||Time to treatment failure was analysed by Kaplan-Meier estimates up to the end of the study. A log-rank test compared linagliptin and empagliflozin pooled versus placebo up to Week 26.||||0.2827
71734714|NCT03429543|142984755|OTHER||Mean Difference (Final Values)|-5.41||||0.6438|TWO_SIDED|95.0|-28.49|17.67|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||17.67|-28.49|0.6438
71734715|NCT03429543|142984755|OTHER||Mean Difference (Final Values)|-35.18||||0.0035|TWO_SIDED|95.0|-58.61|-11.74|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||-11.74|-58.61|0.0035
71734716|NCT03429543|142984755|OTHER||Mean Difference (Final Values)|38.62||||0.031|TWO_SIDED|95.0|4.54|72.7|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||72.70|4.54|0.0310
71734717|NCT03429543|142984755|OTHER||Mean Difference (Final Values)|20.05||||0.1994|TWO_SIDED|95.0|-13.01|53.11|||ANCOVA||Mean difference calculated as \[Treatment\] - Placebo.|Analysis of covariance (ANCOVA) model with treatment as a fixed classification effect, baseline FPG as linear covariate and age at randomisation as categorical covariate. The random error was assumed to be normally distributed.||53.11|-13.01|0.1994
71734718|NCT03429543|142984756|OTHER||Mean Difference (Final Values)|1.46||||0.1394|TWO_SIDED|95.0|-0.48|3.41|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.41|-0.48|0.1394
71734719|NCT03429543|142984756|OTHER||Mean Difference (Final Values)|-0.75||||0.4476|TWO_SIDED|95.0|-2.68|1.19|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.19|-2.68|0.4476
71734720|NCT03429543|142984756|OTHER||Mean Difference (Final Values)|0.05||||0.9789|TWO_SIDED|95.0|-3.8|3.9|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||3.90|-3.80|0.9789
71761349|NCT04901715|143024195|OTHER|||||||0.066|||||||ANOVA|||||||0.066
71761350|NCT04901715|143024195|OTHER|||||||0.58|||||||ANOVA|||||||0.58
71761351|NCT03843541|143024198|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_DEVIATION|0.763|<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||<0.001
71832275|NCT03312907|143168885|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.09|3.14|||||Hazard ratio was calculated using Cox proportional hazards model with covariates: Baseline SLEDAI-2K, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm excluded from model.|||3.14|0.09|
71832276|NCT03312907|143168892|OTHER||Odds Ratio (OR)|1.55||||0.7102|TWO_SIDED|95.0|0.15|15.7|||Regression, Logistic|Week 52|Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab+ Standard therapy arm was excluded from the model.|||15.70|0.15|0.7102
71832277|NCT03312907|143168892|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.1|10.71|||||Odds ratio at Week 52 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant, Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||10.71|0.10|
71832278|NCT03312907|143168892|OTHER||Odds Ratio (OR)|0.9||||0.8641|TWO_SIDED|95.0|0.26|3.15|||Regression, Logistic|Week 104|Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Standard therapy arm was excluded from the model.|||3.15|0.26|0.8641
71832279|NCT03312907|143168892|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.26|5.64|||||Odds ratio at Week 104 was calculated using Logistic regression model with covariates:Baseline SLEDAI-2K,Baseline immunosuppressant,Baseline prednisone equivalent dose and treatment group. Belimumab + Placebo arm was excluded from the model.|||5.64|0.26|
71832280|NCT02576574|143168902|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.007|TWO_SIDED|95.0|0.54|0.93|||Log Rank|||||0.93|0.54|0.0070
71832281|NCT02576574|143168903|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0196|TWO_SIDED|95.0|0.52|0.98|||Log Rank|||||0.98|0.52|0.0196
71832282|NCT02576574|143168904|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1032|TWO_SIDED|95.0|0.67|1.09|||Log Rank|||||1.09|0.67|0.1032
71734721|NCT03429543|142984756|OTHER||Mean Difference (Final Values)|-1.35||||0.5092|TWO_SIDED|95.0|-5.68|2.99|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.99|-5.68|0.5092
71734722|NCT03429543|142984757|OTHER||Mean Difference (Final Values)|0.91||||0.587|TWO_SIDED|95.0|-2.4|4.22|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.22|-2.40|0.5870
71734723|NCT03429543|142984757|OTHER||Mean Difference (Final Values)|-1.42||||0.3967|TWO_SIDED|95.0|-4.72|1.88|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||1.88|-4.72|0.3967
71734724|NCT03429543|142984757|OTHER||Mean Difference (Final Values)|2.53||||0.5414|TWO_SIDED|95.0|-6.42|11.47|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||11.47|-6.42|0.5414
71734725|NCT03429543|142984757|OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-10.13|10.13|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||10.13|-10.13|0.9995
71761352|NCT03843541|143024199|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_DEVIATION|0.783||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.002
71832283|NCT02576574|143168905|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.063|TWO_SIDED|95.0|0.59|1.07|||Log Rank|||||1.07|0.59|0.0630
71832284|NCT02576574|143168906|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0147|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||||0.98|0.62|0.0147
71832285|NCT02576574|143168907|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1753|TWO_SIDED|95.0|0.67|1.15|||Log Rank|||||1.15|0.67|0.1753
71832286|NCT02576574|143168908|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0257|TWO_SIDED|95.0|0.66|1.0|||Log Rank|||||1.00|0.66|0.0257
71832287|NCT02576574|143168909|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0809|TWO_SIDED|95.0|0.66|1.07|||Log Rank|||||1.07|0.66|0.0809
71832288|NCT02576574|143168910|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1294|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||||1.07|0.78|0.1294
71832289|NCT02576574|143168911|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2618|TWO_SIDED|95.0|0.79|1.13|||Log Rank|||||1.13|0.79|0.2618
71761353|NCT03843541|143024200|SUPERIORITY|||||||0.239|||||||Stratified Mann-Whitney U Statistic|||||||0.239
71761354|NCT03843541|143024201|SUPERIORITY|||||||0.037|||||||Stratified Mann-Whitney U Statistic|||For the superiority comparisons of NAC vs. placebo, the Bonferroni correction was used.||||0.037
71761355|NCT03843541|143024202|SUPERIORITY|||||||0.093|||||||Stratified Mann Whitney U Statistic|||||||0.093
71761356|NCT03843541|143024202|SUPERIORITY|||||||0.118|||||||Stratified Mann Whitney U Statistic|||||||0.118
71761357|NCT03843541|143024203|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
71761358|NCT03843541|143024203|SUPERIORITY|||||||0.11|||||||Stratified Mann Whitney U Statistic|||||||0.110
71761359|NCT03843541|143024204|SUPERIORITY|||||||0.022|||||||Stratified Mann Whitney U Statistic|||||||0.022
71761360|NCT03843541|143024204|SUPERIORITY|||||||0.402|||||||Stratified Mann Whitney U Statistic|||||||0.402
71761361|NCT03843541|143024205|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5||||0.002|TWO_SIDED|97.5|0.43|1.0|||Modified Mann-Whitney U Statistic||The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.|||1.00|0.43|0.002
71761362|NCT03843541|143024206|NON_INFERIORITY|Non-inferiority was declared if the one-sided confidence interval was within the interval.|Probability scale treatment difference|0.5|||<|0.001|TWO_SIDED|98.75|0.45|1.0|||Modified Mann-Whitney U Statistic||"The point estimates of treatment differences in probability scale together with associated one-side confidence interval (97.5% or 98.75%) were computed according to Hochberg if both superiority contrasts were found statistically significant.~."|||1.00|0.45|<0.001
71761363|NCT03843541|143024207|SUPERIORITY|||||||0.356|||||||Modified Mann-Whitney U Statistic|||||||0.356
71761364|NCT03843541|143024207|SUPERIORITY|||||||0.007|||||||Modified Mann-Whitney U Statistic|||||||0.007
71761365|NCT03843541|143024208|SUPERIORITY|||||||0.38|||||||Modified Mann-Whitney U Statistic|||||||0.380
71761366|NCT03843541|143024208|SUPERIORITY|||||||0.018|||||||Modified Mann-Whitney U Statistic|||||||0.018
71761367|NCT03843541|143024209|SUPERIORITY|||||||0.366|||||||Modified Mann-Whitney U Statistic|||||||0.366
71761368|NCT03843541|143024209|SUPERIORITY|||||||0.027|||||||Modified Mann-Whitney U Statistic|||||||0.027
71761369|NCT03843541|143024210|SUPERIORITY|||||||0.052|||||||Modified Mann-Whitney U Statistic|||||||0.052
71761370|NCT03843541|143024210|SUPERIORITY|||||||0.058|||||||Modified Mann-Whitney U Statistic|||||||0.058
71734726|NCT03429543|142984758|OTHER||Mean Difference (Final Values)|1.5||||0.2433|TWO_SIDED|95.0|-1.03|4.02|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.02|-1.03|0.2433
71734727|NCT03429543|142984758|OTHER||Mean Difference (Final Values)|0.02||||0.9878|TWO_SIDED|95.0|-2.52|2.56|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||2.56|-2.52|0.9878
71734728|NCT03429543|142984758|OTHER||Mean Difference (Final Values)|3.33||||0.567|TWO_SIDED|95.0|-9.0|15.65|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||15.65|-9.00|0.5670
71734729|NCT03429543|142984758|OTHER||Mean Difference (Final Values)|-6.62||||0.2348|TWO_SIDED|95.0|-18.19|4.95|||Mixed Models Analysis||Mean difference calculated as \[Treatment\] - Placebo.|Mixed model for repeated measures (MMRM) with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the categorical covariate age at randomisation and the continuous, fixed covariates of baseline of the response variable and baseline of the response variable-by-visit interaction. The covariate visit was treated as repeated measure with an unstructured covariance structure used to model the within-patient measurements.||4.95|-18.19|0.2348
71734730|NCT03429543|142984759|OTHER||Rate difference (percentage)|6.0||||0.3536|TWO_SIDED|95.0|-7.7|19.9|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.9|-7.7|0.3536
71734731|NCT03429543|142984759|OTHER||Rate difference (percentage)|11.7||||0.0914|TWO_SIDED|95.0|-2.4|26.3|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||26.3|-2.4|0.0914
71734732|NCT03429543|142984759|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
71734733|NCT03429543|142984759|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
71734734|NCT03429543|142984760|OTHER||Rate difference (percentage)|2.4||||0.7789|TWO_SIDED|95.0|-15.2|19.5|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||19.5|-15.2|0.7789
71734735|NCT03429543|142984760|OTHER||Rate difference (percentage)|10.1||||0.2548|TWO_SIDED|95.0|-7.7|28.1|||Wald test||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and two-sided Wald test.||28.1|-7.7|0.2548
71734736|NCT03429543|142984760|OTHER||Rate difference (percentage)|-23.3||||0.5455|TWO_SIDED|90.0|-67.9|27.1|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||27.1|-67.9|0.5455
71761371|NCT03843541|143024211|SUPERIORITY|||||||0.309|||||||Modified Mann-Whitney U Statistic|||||||0.309
71761372|NCT03843541|143024211|SUPERIORITY|||||||0.006|||||||Modified Mann-Whitney U Statistic|||||||0.006
71761373|NCT05767749|143024229|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.93|TWO_SIDED|95.0|-12.8|14.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Lidocaine + epinephrine vs Bupivacaine)|||14.0|-12.8|0.93
71761374|NCT05767749|143024229|SUPERIORITY||Mean Difference (Final Values)|3.73||||0.54|TWO_SIDED|95.0|-8.3|15.8|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Ropivacaine) minus (Ropivacaine vs Bupivacaine)|||15.8|-8.3|0.54
71761375|NCT05767749|143024229|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.6|TWO_SIDED|95.0|-8.7|15.0|||t-test, 2 sided||Direction = (Lidocaine + epinephrine vs Bupivacaine) minus (Ropivacaine vs Bupivacaine)|||15.0|-8.7|0.60
71775097|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.0072|TWO_SIDED|95.0|-2.02|-0.54||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.54|-2.02|0.00720
71832290|NCT02576574|143168912|SUPERIORITY||Odds Ratio (OR)|1.41||||0.064|TWO_SIDED|95.0|0.91|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.91|0.0640
71832291|NCT02576574|143168913|SUPERIORITY||Odds Ratio (OR)|1.23||||0.2217|TWO_SIDED|95.0|0.73|2.07|||Cochran-Mantel-Haenszel|||||2.07|0.73|0.2217
71661263|NCT03233230|142836128|SUPERIORITY||Response rate difference|0.01|||||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
71734737|NCT03429543|142984760|OTHER||Rate difference (percentage)|26.7||||0.5671|TWO_SIDED|90.0|-30.8|70.8|||Fisher Exact||Difference calculated as \[Treatment\] - Placebo.|The risk difference of active treatments versus placebo was determined and assessed by an exact 2-sided 95% confidence interval. Exact 95% CI by Chan and Zhang. Asymptotic and Fisher's exact test.||70.8|-30.8|0.5671
71734738|NCT03249103|142984774|OTHER|||||||0.032|||||||t-test, 2 sided|||placebo - NYX-2925 20 mg||||0.032
71734739|NCT03249103|142984775|OTHER|||||||0.039|||||||t-test, 2 sided|||placebo - NYX-2925 200 mg||||0.039
71734740|NCT03249103|142984776|OTHER|||||||0.0072|||||||t-test, 2 sided|comparing Week 2 (Placebo) to Week 6 (NYX-2925 200 mg)||||||0.0072
71734741|NCT02428413|142984777|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
71734742|NCT02428413|142984778|SUPERIORITY_OR_OTHER|||||||0.26|||||||t-test, 2 sided|||||||0.26
71734743|NCT02025439|142984781|OTHER||Mean Difference (Final Values)|0.071|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71734744|NCT01786252|142984782|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.||||<0.05
71734745|NCT01786252|142984782|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.||||>0.05
71734746|NCT01786252|142984782|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare stromal staging between hCG and IVF media group.||||<0.01
71832292|NCT02576574|143168914|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1912|TWO_SIDED|95.0|0.81|1.72|||Cochran-Mantel-Haenszel|||||1.72|0.81|0.1912
71832293|NCT02576574|143168915|SUPERIORITY||Odds Ratio (OR)|1.0||||0.4951|TWO_SIDED|95.0|0.64|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.64|0.4951
71734747|NCT01786252|142984782|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.||||>0.05
71734748|NCT01786252|142984783|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71734749|NCT01786252|142984784|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71832294|NCT00914589|143168953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0482||||0.8648||95.0|0.6095|1.8029||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.8029|0.6095|0.8648
71832295|NCT00914589|143168953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9871||||0.9634||95.0|0.5673|1.7176||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic|||||1.7176|0.5673|0.9634
71832296|NCT01290341|143168958|SUPERIORITY_OR_OTHER||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification by site was used to compare subjects with complete cure between NAFT-600 and Placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1\<=p0 versus Ha (alternate): p1\>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."||||<0.025
71661264|NCT03233230|142836128|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71734750|NCT01786252|142984785|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71734751|NCT03688100|142984790|SUPERIORITY||ratio of means|0.62||||0.005|TWO_SIDED|95.0|0.45|0.86||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 3 MONTHS||0.86|0.45|0.005
71734752|NCT03688100|142984790|SUPERIORITY||ratio of means|0.7||||0.008|TWO_SIDED|95.0|0.6|0.86||The a priori threshold for statistical significance is p\<0.05|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits, BA is the numerator and MEDS is the denominator.|Emergency Department visits AT 6 MONTHS||0.86|0.60|0.008
71734753|NCT03688100|142984790|SUPERIORITY||ratio of means|0.73||||0.0001|TWO_SIDED|95.0|0.62|0.85||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means for ED visits , BA is numerator and MEDS is the denominator.|Emergency Department visits AT 12 MONTHS||0.85|0.62|0.0001
71734754|NCT03688100|142984791|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model|||Differences in the number of hospital readmissions between BA and MEDS at 3, 6, and 12 months||||>0.05
71734755|NCT03688100|142984792|SUPERIORITY||ratio of means|0.83||||0.002|TWO_SIDED|95.0|0.75|0.92||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital at 3 months||0.92|0.75|0.002
71734756|NCT03688100|142984792|SUPERIORITY||ratio of means|0.81||||0.005|TWO_SIDED|95.0|0.75|0.87||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is numerator and MEDS is the denominator.|Days in the Hospital at 6 MONTHS||0.87|0.75|0.005
71734757|NCT03688100|142984792|SUPERIORITY||ratio of means|0.64|||<|0.0001|TWO_SIDED|95.0|0.6|0.68||The a priori threshold for statistical significance is p\<0.05.|Zero Inflated Poisson (ZIP) Model||For the ratio of means, BA is the numerator and MEDS is the denominator.|Days in the Hospital AT 12 MONTHS||0.68|0.60|<0.0001
71734758|NCT03688100|142984793|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is p\<0.05.|Kaplan Meier survival plots|||||||>0.05
71734759|NCT02437084|142984852|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|SSPG concentration was log-transformed for statistical analysis; degrees of freedom = 69||Null hypothesis: There will be no change in steady-state plasma glucose (SSPG) concentration after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||0.01
71734760|NCT02437084|142984853|OTHER||||||<|0.001|||||||Paired samples t test, 2 sided|Insulin secretion rate AUC was log-transformed for statistical analysis; degrees of freedom = 63.||Null hypothesis: There will be no change in insulin secretion rate AUC after treatment with atorvastatin 40 mg daily for 9 - 10 weeks.||||<0.001
71734761|NCT02437084|142984854|OTHER|||||||0.1|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in fasting plasma glucose concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.10
71734762|NCT02437084|142984855|OTHER|||||||0.01|||||||Paired samples t test, 2 sided|Fasting plasma insulin concentration was log-transformed for statistical analysis; degrees of freedom = 68||Null hypothesis: There will be no change in fasting plasma insulin concentration after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.01
71734763|NCT02437084|142984856|OTHER|||||||0.03|||||||Paired samples t test, 2 sided|Degrees of freedom = 70||Null hypothesis: There will be no change in OGTT glucose AUC after treatment with atorvastatin 40 mg daily for 8 - 10 weeks.||||0.03
71734764|NCT02437084|142984857|OTHER|||||||0.27|||||||Paired samples t test, 2 sided|OGTT insulin AUC was log-transformed for statistical analysis; degrees of freedom = 63||Null hypothesis: There will be no change in OGTT insulin AUC after treatment with atorvastatin 40 mg daily for 8 weeks.||||0.27
71734765|NCT04566692|142984917|NON_INFERIORITY|The bi-weekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|1.035|||||TWO_SIDED|90.0|1.003|1.0685||||||Geometric least-squares means (GLSMs), GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participant as a random effect.||1.0685|1.0030|
71773220|NCT00395538|143046112|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.328||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.328
71773221|NCT00395538|143046113|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.ES/BS values for both their baseline and year 1 biopsies.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
71773222|NCT00395538|143046113|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||<0.001
71775098|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.04884|TWO_SIDED|95.0|-1.81|-0.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.29|-1.81|0.04884
71832297|NCT01102231|143168970|OTHER||Proportion difference|0.905|||||TWO_SIDED|95.0|0.846|0.964||||||||0.964|0.846|
71832298|NCT03903822|143168973|SUPERIORITY||Least square (LS) mean difference|-13.9|STANDARD_ERROR_OF_MEAN|11.04||0.104|TWO_SIDED|90.0|-32.1|4.3|||ANCOVA|||Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.||4.3|-32.1|0.1040
71832299|NCT03903822|143168973|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|11.0||0.0334|TWO_SIDED|90.0|-38.3|-2.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-2.1|-38.3|0.0334
71832300|NCT03903822|143168973|SUPERIORITY||LS Mean Difference|-25.6|STANDARD_ERROR_OF_MEAN|10.75||0.0086|TWO_SIDED|90.0|-43.3|-8.0|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-8.0|-43.3|0.0086
71832301|NCT03903822|143168973|SUPERIORITY||LS Mean Difference|-23.5|STANDARD_ERROR_OF_MEAN|10.93||0.0158|TWO_SIDED|90.0|-41.5|-5.5|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-5.5|-41.5|0.0158
71734766|NCT04566692|142984920|NON_INFERIORITY|The biweekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \> 0.8.|GLSM Ratio|0.97|||||TWO_SIDED|90.0|0.9447|0.9957||||||GLSMs, GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participants as a random effect.||0.9957|0.9447|
71734767|NCT01300260|142984981|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.41|3.64||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.64|2.41|<0.001
71832302|NCT03903822|143168973|SUPERIORITY||LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|8.11||0.0879|TWO_SIDED|90.0|-24.3|2.4|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||2.4|-24.3|0.0879
71734768|NCT01300260|142984981|SUPERIORITY_OR_OTHER||Geometric least squares (LS) means ratio|5.4|||<|0.001|TWO_SIDED|95.0|4.09|7.13||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||7.13|4.09|<0.001
71734769|NCT01300260|142984982|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.09|||<|0.001|TWO_SIDED|95.0|2.66|3.59||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.59|2.66|<0.001
71734770|NCT01300260|142984982|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|7.92|||<|0.001|TWO_SIDED|95.0|4.82|13.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||13.0|4.82|<0.001
71734771|NCT01300260|142984983|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|4.15|||<|0.001|TWO_SIDED|95.0|3.45|5.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||5.00|3.45|<0.001
71734772|NCT01300260|142984983|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|3.78|||<|0.001|TWO_SIDED|95.0|2.99|4.78||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||4.78|2.99|<0.001
71734773|NCT01300260|142984984|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.04||||0.011|TWO_SIDED|95.0|1.26|3.31||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.31|1.26|0.011
71734774|NCT01300260|142984984|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|2.44|||<|0.001|TWO_SIDED|95.0|1.71|3.47||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||3.47|1.71|<0.001
71734775|NCT01300260|142984985|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.22||||0.021|TWO_SIDED|95.0|1.04|1.43||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.43|1.04|0.021
71734776|NCT01300260|142984985|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.27|1.53||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.53|1.27|<0.001
71734777|NCT01300260|142984986|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.43||||0.009|TWO_SIDED|95.0|1.14|1.8||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.80|1.14|0.009
71832303|NCT03903822|143168973|SUPERIORITY||LS Mean Difference|-27.4|STANDARD_ERROR_OF_MEAN|8.11||0.0004|TWO_SIDED|90.0|-40.7|-14.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-14.1|-40.7|0.0004
71734778|NCT01300260|142984986|SUPERIORITY_OR_OTHER||Geometric least squares (LS) mean ratio|1.75|||<|0.001|TWO_SIDED|95.0|1.59|1.94||P-value is 2-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.||||1.94|1.59|<0.001
71734779|NCT00377364|142984988|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline RAVLT scores used as covariate.||||<0.05
71734780|NCT00377364|142984991|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ISS scores used as a covariate. ANCOVA results were not significant.||||||<0.05
71734781|NCT00377364|142984992|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Baseline HRSD scores used as a covariate.||||<0.05
71734782|NCT00377364|142984994|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Baseline YMRS scores used as a covariate.||||||0.05
71734783|NCT00377364|142984996|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|Baseline ACQ scores used as a covariate.||||||<0.05
71734784|NCT00439374|142985003|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.79|1.35||||||All deliveries less than 37 weeks||1.35|0.79|
71734785|NCT00439374|142985003|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.7|1.4||||||Spontaneous deliveries||1.40|0.70|
71734786|NCT00439374|142985003|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.65|1.84||||||Medically-indicated deliveries||1.84|0.65|
71734787|NCT00439374|142985004|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||||||0.93
71734788|NCT00439374|142985005|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.61|1.8||||||||1.80|0.61|
71734789|NCT00439374|142985006|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.58|1.21||||||||1.21|0.58|
71734790|NCT00439374|142985007|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.43||||||||1.43|0.54|
71734791|NCT00439374|142985008|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3||||||||1.30|0.36|
71734792|NCT00439374|142985009|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.82|1.15||||||||1.15|0.82|
71734793|NCT00439374|142985010|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.55|1.29||||||||1.29|0.55|
71734794|NCT00439374|142985011|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.77|1.55||||||||1.55|0.77|
71734795|NCT00439374|142985012|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.43|5.33||||||||5.33|0.43|
71734796|NCT00439374|142985013|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.78|1.72||||||||1.72|0.78|
71734797|NCT00439374|142985014|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.56|2.41||||||||2.41|0.56|
71734798|NCT00439374|142985016|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.34|1.58||||||||1.58|0.34|
71734799|NCT00439374|142985017|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.84|2.52||||||||2.52|0.84|
71734800|NCT00439374|142985018|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.79|1.46||||||||1.46|0.79|
71734801|NCT00439374|142985019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||Any side effect||1.13|0.92|
71734802|NCT00439374|142985019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.93|1.17||||||Injection site||1.17|0.93|
71734803|NCT00439374|142985019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.03|||||TWO_SIDED|95.0|1.11|22.78||||||Urticaria||22.78|1.11|
71734804|NCT00439374|142985019|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.27|1.83||||||Nausea||1.83|0.27|
71734805|NCT00439374|142985020|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.46|1.3||||||Analysis is for the total composite||1.30|0.46|
71661265|NCT03233230|142836129|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.02|0.09||||||||0.09|-0.02|
71661266|NCT03233230|142836129|SUPERIORITY||Response rate difference|0.05|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|-0.00|
71734806|NCT00439374|142985021|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
71734807|NCT00439374|142985029|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71734808|NCT02540265|142985032|OTHER||Effect Size|1.01|||||TWO_SIDED|||||||||||||
71734809|NCT02540265|142985032|OTHER||Effect Size|0.87|||||TWO_SIDED|||||||||||||
71734810|NCT02540265|142985033|SUPERIORITY|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
71734811|NCT02540265|142985033|SUPERIORITY|||||||0.0076|||||||t-test, 2 sided|||||||0.0076
71734812|NCT02540265|142985034|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
71734813|NCT02540265|142985034|SUPERIORITY||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided|||||||<0.05
71734814|NCT02102399|142985055|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.001
71734815|NCT02102399|142985056|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.345
71734816|NCT02102399|142985057|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
71734817|NCT02102399|142985058|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.171
71734818|NCT02102399|142985059|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.022
71734819|NCT02102399|142985060|SUPERIORITY_OR_OTHER|||||||0.451|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.451
71734820|NCT02102399|142985061|SUPERIORITY_OR_OTHER|||||||0.477|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.477
71734821|NCT02102399|142985062|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.007
71734822|NCT02102399|142985063|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.049
71734823|NCT02102399|142985064|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.323
71734824|NCT02102399|142985065|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.296
71734825|NCT02102399|142985066|SUPERIORITY_OR_OTHER|||||||0.776|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.776
71734826|NCT02102399|142985067|SUPERIORITY_OR_OTHER|||||||0.959|TWO_SIDED||||||Wilcoxon's signed-rank test|||||||0.959
71734827|NCT02102399|142985068|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.76
71734828|NCT02102399|142985069|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
71734829|NCT02102399|142985070|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
71734830|NCT02102399|142985071|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.77
71734831|NCT02102399|142985072|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.49
71734832|NCT02102399|142985073|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.74
71734833|NCT02102399|142985074|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Fisher Exact|||||||0.120
71734834|NCT02102399|142985075|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.030
71734835|NCT02102399|142985076|SUPERIORITY_OR_OTHER|||||||0.107|TWO_SIDED||||||Fisher Exact|||||||0.107
71734836|NCT03101085|142985077|OTHER|We performed a paired T-test analysis to ascertain whether the COX/CS activity while on S-equol was comparable or different than the COX/CS while on placebo. For each participant, the COX/CS value while on S-equol was subtracted from their COX/CS value while on placebo.|||||>|0.05|||||||Paired T-test|||As the order of the intervention does not matter, all 39 participants who contributed data to the final analysis are included together.||||>0.05
71734837|NCT04583956|142985102|SUPERIORITY||Odds Ratio (OR)|0.98||||0.927|TWO_SIDED|95.0|0.59|1.61|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while participants lost to follow-up after discharge to home are assigned a score of 2.||1.61|0.59|0.927
71832304|NCT03903822|143168974|SUPERIORITY||Risk Difference (RD)|18.9||||0.0244|TWO_SIDED|90.0|2.4|34.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||34.7|2.4|0.0244
71832305|NCT03903822|143168974|SUPERIORITY||Risk Difference (RD)|22.5||||0.0113|TWO_SIDED|90.0|4.8|38.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||38.6|4.8|0.0113
71832306|NCT03903822|143168974|SUPERIORITY||Risk Difference (RD)|29.7||||0.0018|TWO_SIDED|90.0|11.0|45.7|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||45.7|11.0|0.0018
71832307|NCT03903822|143168974|SUPERIORITY||Risk Difference (RD)|33.6||||0.0007|TWO_SIDED|90.0|13.7|49.9|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||49.9|13.7|0.0007
71832308|NCT03903822|143168974|SUPERIORITY||Risk Difference (RD)|19.4||||0.0289|TWO_SIDED|90.0|1.8|36.5|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||36.5|1.8|0.0289
71832309|NCT03903822|143168974|SUPERIORITY||Risk Difference (RD)|13.1||||0.1145|TWO_SIDED|90.0|-2.9|29.6|||Chan and Zhang Exact Method|||Risk difference = difference in percentage of participants.||29.6|-2.9|0.1145
71832310|NCT03903822|143168975|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.79||0.0488|TWO_SIDED|90.0|-2.61|-0.01|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.01|-2.61|0.0488
71832311|NCT03903822|143168975|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.788||0.0413|TWO_SIDED|90.0|-2.66|-0.07|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.07|-2.66|0.0413
71832312|NCT03903822|143168975|SUPERIORITY||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|0.773||0.02|TWO_SIDED|90.0|-2.86|-0.32|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.32|-2.86|0.0200
71832313|NCT03903822|143168975|SUPERIORITY||LS Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.758||0.0011|TWO_SIDED|90.0|-3.58|-1.08|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-1.08|-3.58|0.0011
71659670|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||71.49|45.93|<0.001
71659671|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.64||||0.105|TWO_SIDED|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.67|-1.38|0.105
71659672|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71659673|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|51.9|||<|0.001|TWO_SIDED|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||65.04|38.76|<0.001
71659674|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|44.89|||<|0.001||95.0|31.51|58.26|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||58.26|31.51|<0.001
71659675|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.36||||0.113|TWO_SIDED|95.0|-1.73|16.45|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.45|-1.73|0.113
71734838|NCT04583956|142985103|SUPERIORITY||Odds Ratio (OR)|0.9||||0.829|TWO_SIDED|95.0|0.36|2.25|||Regression, Logistic||Odds ratio greater than 1 favors Remdesivir plus Risankizumab.|Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).||2.25|0.36|0.829
71734839|NCT04583956|142985104|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.399|TWO_SIDED|95.0|0.84|1.56|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.56|0.84|0.399
71734840|NCT04583956|142985105|SUPERIORITY||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.62|1.71|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.71|0.62|0.910
71659676|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
71659677|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
71659678|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71659679|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659680|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659681|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659682|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
71659683|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
71661267|NCT03233230|142836129|SUPERIORITY||Response rate difference|0.02|||||TWO_SIDED|95.0|-0.03|0.08||||||||0.08|-0.03|
71832314|NCT03903822|143168975|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.535||0.0727|TWO_SIDED|90.0|-1.66|0.1|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||0.10|-1.66|0.0727
71832315|NCT03903822|143168975|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.534||0.001|TWO_SIDED|90.0|-2.52|-0.77|||ANCOVA|||ANCOVA contained fixed factors of treatment and baseline value.||-0.77|-2.52|0.0010
71661268|NCT03233230|142836130|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71832316|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|0.5||||0.5246|TWO_SIDED|90.0|-14.7|16.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||16.4|-14.7|0.5246
71734841|NCT04583956|142985106|SUPERIORITY||Odds Ratio (OR)|1.14||||0.617|TWO_SIDED|95.0|0.68|1.93|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Risankizumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for those lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.93|0.68|0.617
71734842|NCT04583956|142985139|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.46|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.46|0.82|0.550
71734843|NCT04583956|142985140|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.523|TWO_SIDED|95.0|0.82|1.48|||Regression, Cox||HR greater than 1 favors Remdesivir plus Risankizumab.|Hazard ratio (HR), confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||1.48|0.82|0.523
71734844|NCT04016077|142985143|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|118.5|||||TWO_SIDED|90.0|87.96|159.64|||ANOVA|||||159.64|87.96|
71734845|NCT04016077|142985144|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Geometric Means|104.0|||||TWO_SIDED|90.0|74.48|145.23|||ANOVA|||||145.23|74.48|
71734846|NCT02100475|142985161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.427|TWO_SIDED|95.0|-1.05|0.46|||ANCOVA|||The response and change from baseline in the response after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) method with treatment and baseline IDegLira dose strata as fixed factors and baseline response as a covariate. Missing data were imputed using LOCF.||0.46|-1.05|0.427
71734847|NCT00757822|142985180|SUPERIORITY_OR_OTHER||Difference in Percentages|4.6|||>|0.76|TWO_SIDED|90.0|-9.5|18.6|||Fisher Exact|||The incidence of PON per arm will be determined and expressed as a percentage of the total patients per arm. Treatment efficacy will be measured as the percentage-point decrease in PON in the treatment arm (Marinol) compared to the standard therapy arm (ondansetron). Null hypothesis: Marinol treatment is not superior to ondansetron treatment. We will test the statistical significance with Fisher's Exact test at a significance level of 0.05||18.6|-9.5|>0.76
71734848|NCT00757822|142985181|SUPERIORITY_OR_OTHER||||||>|0.92|||||||Fisher Exact|One-sided Fisher's Exact test was performed comparing the percentage of subjects with at least one VAS score \> 0. (Marinol\>Ondansetron).||||||>0.92
71734849|NCT00757822|142985182|SUPERIORITY_OR_OTHER||Difference in Percentages|7.7|||>|0.55|TWO_SIDED|90.0|-12.1|13.3|||Fisher Exact|||||13.3|-12.1|>0.55
71734850|NCT00757822|142985183|SUPERIORITY_OR_OTHER||||||=|0.981|TWO_SIDED||||||Wilcoxon Rank-Sum test|||||||=0.981
71734851|NCT00757822|142985184|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Fisher Exact|||||||>0.90
71734852|NCT00757822|142985185|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Fisher Exact|||||||>0.37
71734853|NCT00757822|142985186|SUPERIORITY_OR_OTHER||||||>|0.75|TWO_SIDED||||||FREQ Procedure|||Comparisons at 24-48 hr post-surgery. Null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction.||||>0.75
71734854|NCT00757822|142985186|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||FREQ procedure|||Comparisons of both arms at 2-6 weeks; null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction||||>0.10
71734855|NCT00757822|142985187|SUPERIORITY_OR_OTHER||||||>|0.29|TWO_SIDED||||||FREQ procedure|||Comparison of both group responses at 24-48 hours.||||>0.29
71734856|NCT00757822|142985187|SUPERIORITY_OR_OTHER||||||>|0.55|TWO_SIDED||||||FREQ Procedure|||Comparisons of both arms at 2-6 weeks.||||>0.55
71734857|NCT02814175|142985191|OTHER|Between group difference|point estimate difference|28.3|||<|0.001|TWO_SIDED|95.0|17.8|38.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor which is the duration of prior MTX 15 mg ew use of ≤ 3 months or \> 3 months.||||38.9|17.8|< 0.001
71832317|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|3.8||||0.3906|TWO_SIDED|90.0|-12.5|19.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||19.9|-12.5|0.3906
71832318|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|13.5||||0.1193|TWO_SIDED|90.0|-3.2|30.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||30.6|-3.2|0.1193
71832319|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|28.2||||0.0048|TWO_SIDED|90.0|8.8|45.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||45.5|8.8|0.0048
71832320|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|14.7||||0.0777|TWO_SIDED|90.0|-2.0|31.1|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.1|-2.0|0.0777
71734858|NCT03416127|142985206|OTHER|||||||0.031|||||||Kruskal-Wallis|||||||0.031
71734859|NCT03416127|142985207|OTHER|||||||0.963|||||||Kruskal-Wallis|||||||0.963
71734860|NCT03416127|142985208|OTHER|||||||0.236|||||||Kruskal-Wallis|||||||0.236
71734861|NCT03416127|142985209|OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71734862|NCT03416127|142985210|OTHER|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71734863|NCT03416127|142985211|OTHER|||||||0.162|||||||Kruskal-Wallis|||||||0.162
71734864|NCT03416127|142985212|OTHER|||||||0.686|||||||Kruskal-Wallis|||||||0.686
71734865|NCT03416127|142985213|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71734866|NCT03416127|142985214|OTHER|||||||0.945|||||||Kruskal-Wallis|||||||0.945
71734867|NCT03416127|142985215|OTHER|||||||0.332|||||||Kruskal-Wallis|||||||0.332
71734868|NCT03416127|142985216|OTHER|||||||0.075|||||||Kruskal-Wallis|||||||0.075
71734869|NCT03416127|142985217|OTHER|||||||0.903|||||||Kruskal-Wallis|||||||0.903
71734870|NCT03416127|142985218|OTHER|||||||0.697|||||||Kruskal-Wallis|||||||0.697
71734871|NCT03416127|142985219|OTHER|||||||0.668|||||||Kruskal-Wallis|||||||0.668
71734872|NCT03416127|142985220|OTHER|||||||0.308|||||||Kruskal-Wallis|||||||0.308
71734873|NCT03416127|142985221|OTHER|||||||0.318|||||||Kruskal-Wallis|||||||0.318
71734874|NCT03416127|142985222|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
71734875|NCT03416127|142985223|OTHER|||||||0.376|||||||Kruskal-Wallis|||||||0.376
71734876|NCT03416127|142985224|OTHER|||||||0.21|||||||Kruskal-Wallis|||||||0.210
71734877|NCT03416127|142985225|OTHER|||||||0.88|||||||Kruskal-Wallis|||||||0.880
71734878|NCT03416127|142985226|OTHER|||||||0.059|||||||Kruskal-Wallis|||||||0.059
71773223|NCT00395538|143046113|EQUIVALENCE|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.789||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.789
71773224|NCT00395538|143046114|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.AjAR values for both their baseline and year 1 biopsies.||||||0.651||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.651
71773225|NCT00395538|143046114|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.58||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.580
71773226|NCT00395538|143046114|OTHER|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.338||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.338
71773227|NCT00395538|143046115|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the year 1 biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.020
71773228|NCT00395538|143046115|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the years 2 and 4 (combined) biopsy.||||||0.11||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.110
71773229|NCT00395538|143046115|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.764||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.764
71832321|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|11.8||||0.1245|TWO_SIDED|90.0|-4.3|28.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.0|-4.3|0.1245
71832322|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|6.2||||0.3322|TWO_SIDED|90.0|-12.2|24.4|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||24.4|-12.2|0.3322
71734879|NCT03416127|142985227|OTHER|||||||0.978|||||||Kruskal-Wallis|||||||0.978
71734880|NCT03416127|142985228|OTHER|||||||0.122|||||||Kruskal-Wallis|||||||0.122
71734881|NCT03416127|142985229|OTHER|||||||0.551|||||||Kruskal-Wallis|||||||0.551
71734882|NCT02397057|142985231|OTHER|Observed cases, logistic regression analysis. Subjects with missing data on Day 42 were excluded from the statistical testing.|Odds Ratio (OR)|1.35||||0.369|TWO_SIDED|95.0|0.7|2.63||p-value was estimated by logistic regression with treatment, region (US, EUR), and baseline RLS medication-related augmentation as fixed factors, and baseline IRLS as a covariate.|Regression, Logistic|||||2.63|0.70|0.3690
71659684|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71659685|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659686|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659687|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659688|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|56.94|||<|0.001|TWO_SIDED|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||69.94|43.95|<0.001
71659689|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|6.07||||0.136|TWO_SIDED|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||14.05|-1.91|0.136
71659690|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|13.98||||0.002|TWO_SIDED|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||22.67|5.30|0.002
71659691|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|50.74|||<|0.001|TWO_SIDED|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||64.09|37.39|<0.001
71659692|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|43.16|||<|0.001|TWO_SIDED|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||56.75|29.56|<0.001
71659693|NCT02912650|142833435|SUPERIORITY_OR_OTHER||CMH adjusted proportions|7.91||||0.087|TWO_SIDED|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.||16.97|-1.15|0.087
71659694|NCT02912650|142833436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71659695|NCT02912650|142833436|SUPERIORITY_OR_OTHER|||||||0.004|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.004
71659696|NCT02912650|142833436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71659697|NCT02912650|142833436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71659698|NCT02912650|142833436|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||<0.001
71659699|NCT02912650|142833436|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.||||0.003
71734883|NCT02397057|142985235|OTHER||Least square(LS) mean difference|-4.071|STANDARD_ERROR_OF_MEAN|2.542||0.1108|TWO_SIDED|95.0|-9.083|0.941|||ANCOVA|||LOCF, ANCOVA Analysis||0.941|-9.083|0.1108
71734884|NCT02397057|142985236|OTHER|||||||0.0002||||||p-value was estimated using continuity-corrected chi-square test.|Chi-squared, Corrected|||||||0.0002
71734885|NCT04473664|142985237|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|95.1|||||TWO_SIDED|90.0|77.1|117.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||117|77.1|
71661269|NCT03233230|142836130|SUPERIORITY||Response rate difference|0.04|||||TWO_SIDED|95.0|0.0|0.1||||||||0.10|0.00|
71661270|NCT03233230|142836130|SUPERIORITY||Response rate difference|0.03|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71661271|NCT03233230|142836131|SUPERIORITY||Response rate difference|0.11|||||TWO_SIDED|95.0|-0.03|0.24||||||||0.24|-0.03|
71661272|NCT03233230|142836131|SUPERIORITY||Response rate difference|0.12|||||TWO_SIDED|95.0|-0.02|0.25||||||||0.25|-0.02|
71659700|NCT02980874|142833459|SUPERIORITY||Difference in percentages|-6.1||||0.187|TWO_SIDED|95.0|-15.2|3.0||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.0|-15.2|0.187
71734886|NCT04473664|142985239|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|59.5|201.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||201|59.5|
71889472|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-25.4|||<|0.001|TWO_SIDED|95.0|-37.7|-13.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-13.1|-37.7|<0.001
71889473|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-9.5||||0.068|TWO_SIDED|95.0|-19.7|0.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.7|-19.7|0.068
71889474|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-23.1|||<|0.001|TWO_SIDED|95.0|-35.3|-10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-10.9|-35.3|<0.001
71889475|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-3.8||||0.459|TWO_SIDED|95.0|-13.8|6.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||6.3|-13.8|0.459
71889476|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-9.4||||0.13|TWO_SIDED|95.0|-21.5|2.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||2.8|-21.5|0.130
71659701|NCT00922987|142833489|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||||||<0.0001
71659702|NCT00446199|142833497|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659703|NCT00446199|142833497|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659704|NCT00446199|142833497|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
71661273|NCT03233230|142836131|SUPERIORITY||Response rate difference|0.18|||||TWO_SIDED|95.0|0.05|0.31||||||||0.31|0.05|
71661274|NCT00392236|142836216|SUPERIORITY_OR_OTHER|||||||0.083|||||||ANOVA|||||||0.083
71661275|NCT03275064|142836245|SUPERIORITY||Mean Difference (Net)|0.48|||||TWO_SIDED|90.0|-30.73|31.69|||Mixed Models Analysis|||Week 16||31.69|-30.73|
71659705|NCT00446199|142833498|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/ van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659706|NCT00446199|142833498|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659707|NCT00446199|142833498|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659708|NCT00446199|142833499|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659709|NCT00446199|142833499|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659710|NCT00446199|142833499|SUPERIORITY_OR_OTHER|||||||0.0096||95.0||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0096
71659711|NCT00446199|142833500|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659712|NCT00446199|142833500|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659713|NCT00446199|142833500|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.||||0.0005
71659714|NCT00446199|142833501|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659715|NCT00446199|142833501|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659716|NCT00446199|142833501|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3 mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659717|NCT00446199|142833502|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659718|NCT00446199|142833502|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71661276|NCT03275064|142836245|SUPERIORITY||Mean Difference (Net)|3.68|||||TWO_SIDED|90.0|-27.04|34.4|||Mixed Models Analysis|||Week 28||34.40|-27.04|
71661277|NCT03275064|142836246|SUPERIORITY||Mean Difference (Final Values)|1.69|||||TWO_SIDED|90.0|-27.7|31.08|||Mixed Models Analysis|||Week 16||31.08|-27.70|
71832323|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|18.5||||0.0535|TWO_SIDED|90.0|-0.3|36.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||36.5|-0.3|0.0535
71659719|NCT00446199|142833502|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.||||<0.0001
71659720|NCT00446199|142833503|SUPERIORITY_OR_OTHER|||||||0.0314||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0314
71734887|NCT04473664|142985239|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean]|109.0|||||TWO_SIDED|90.0|57.9|207.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||207|57.9|
71773230|NCT00395538|143046116|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the year 1 biopsy.||||||0.227||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.227
71773231|NCT00395538|143046116|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the years 2 and 4 (combined) biopsy.||||||0.194||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.194
71659721|NCT00446199|142833503|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8780
71659722|NCT00446199|142833503|SUPERIORITY_OR_OTHER|||||||0.5908||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.5908
71659723|NCT00446199|142833504|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0027
71659724|NCT00446199|142833504|SUPERIORITY_OR_OTHER|||||||0.4463||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4463
71659725|NCT00446199|142833504|SUPERIORITY_OR_OTHER|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0303
71659726|NCT00446199|142833505|SUPERIORITY_OR_OTHER|||||||0.4397||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4397
71659727|NCT00446199|142833505|SUPERIORITY_OR_OTHER|||||||0.0132||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.0132
71659728|NCT00446199|142833505|SUPERIORITY_OR_OTHER|||||||0.325||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.3250
71734888|NCT04473664|142985243|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|74.4|||||TWO_SIDED|90.0|32.0|173.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||173|32.0|
71832324|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|24.3||||0.0159|TWO_SIDED|90.0|4.5|41.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.9|4.5|0.0159
71659729|NCT00446199|142833506|SUPERIORITY_OR_OTHER|||||||0.9555||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.9555
71659730|NCT00446199|142833506|SUPERIORITY_OR_OTHER|||||||0.1743||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.1743
71659731|NCT00446199|142833506|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.4395
71659732|NCT00446199|142833507|SUPERIORITY_OR_OTHER|||||||0.8966||95.0||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8966
71659733|NCT00446199|142833507|SUPERIORITY_OR_OTHER|||||||0.7512||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.7512
71659734|NCT00446199|142833507|SUPERIORITY_OR_OTHER|||||||0.8751||95.0|||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2\*4 table||||0.8751
71659735|NCT00446199|142833508|SUPERIORITY_OR_OTHER|||||||0.1067||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.1067
71659736|NCT00446199|142833508|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.6011
71659737|NCT00446199|142833508|SUPERIORITY_OR_OTHER|||||||0.4408||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.4408
71659738|NCT00446199|142833509|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.0144
71659739|NCT00446199|142833509|SUPERIORITY_OR_OTHER|||||||0.5589||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5589
71659740|NCT00446199|142833509|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.5500
71659741|NCT00446199|142833510|SUPERIORITY_OR_OTHER|||||||0.2179||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.2179
71734889|NCT04473664|142985245|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|62.5|||||TWO_SIDED|90.0|35.3|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for AC886.||111|35.3|
71659742|NCT00446199|142833510|SUPERIORITY_OR_OTHER|||||||0.7749||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.7749
71659743|NCT00446199|142833510|SUPERIORITY_OR_OTHER|||||||0.8307||95.0|||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo||||0.8307
71659744|NCT00446199|142833511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|||<|0.0001||95.0|-33.2|-22.0||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-22.0|-33.2|<0.0001
71659745|NCT00446199|142833511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||<|0.0001||95.0|-27.8|-16.6||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-16.6|-27.8|<0.0001
71661278|NCT03275064|142836246|SUPERIORITY||Mean Difference (Net)|5.97|||||TWO_SIDED|90.0|-23.03|34.97|||Mixed Models Analysis|||Week 28||34.97|-23.03|
71661279|NCT03275064|142836247|SUPERIORITY||Mean Difference (Net)|0.88|||||TWO_SIDED|90.0|-47.27|49.04|||Mixed Models Analysis|||Week 16||49.04|-47.27|
71659746|NCT00446199|142833511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8||||0.0007||95.0|-15.4|-4.2||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline||-4.2|-15.4|0.0007
71889477|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-22.3|||<|0.001|TWO_SIDED|95.0|-32.3|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-12.3|-32.3|<0.001
71889478|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-3.4||||0.577|TWO_SIDED|95.0|-15.6|8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||8.7|-15.6|0.577
71889479|NCT00792298|143300605|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-2.3||||0.644|TWO_SIDED|95.0|-12.2|7.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||7.5|-12.2|0.644
71659747|NCT00446199|142833512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||<|0.0001||95.0|-29.9|17.8||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||17.8|-29.9|<0.0001
71889480|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-22.3||||0.007|TWO_SIDED|95.0|-38.3|-6.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-6.2|-38.3|0.007
71889481|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-19.6||||0.024|TWO_SIDED|95.0|-36.6|-2.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-2.6|-36.6|0.024
71889482|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-31.0|||<|0.001|TWO_SIDED|95.0|-46.9|-15.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-15.2|-46.9|<0.001
71889483|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-15.7||||0.063|TWO_SIDED|95.0|-32.3|0.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||0.8|-32.3|0.063
71773232|NCT00395538|143046116|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.434||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.434
71773233|NCT00395538|143046117|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.003
71659748|NCT00446199|142833512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.0001||95.0|-20.2|-8.1||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-8.1|-20.2|<0.0001
71659749|NCT00446199|142833512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0054||95.0|-14.6|-2.5||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-2.5|-14.6|0.0054
71659750|NCT00446199|142833513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|||<|0.0001||95.0|-1.28|-0.859||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.859|-1.280|<0.0001
71659751|NCT00446199|142833513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803|||<|0.0001||95.0|-1.013|-0.593||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.593|-1.013|<0.0001
71659752|NCT00446199|142833513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.361||||0.0007||95.0|-0.57|-0.152||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.152|-0.570|0.0007
71832325|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|36.8||||0.0008|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||54.0|15.4|0.0008
71659753|NCT00446199|142833514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.635|||<|0.0001||95.0|-0.813|-0.458||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.458|-0.813|<0.0001
71659754|NCT00446199|142833514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|||<|0.0001||95.0|-0.56|-0.205||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.205|-0.560|<0.0001
71659755|NCT00446199|142833514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.204||||0.0233||95.0|-0.381|-0.028||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between E2 (0.3) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.||-0.028|-0.381|0.0233
71659756|NCT03982199|142833520|SUPERIORITY||Event Rate|80.0||||4e-05|TWO_SIDED|94.211|52.2|92.9|||Poisson regression|||Case Definition 1||92.9|52.2|0.00004
71659757|NCT03982199|142833520|SUPERIORITY||Event Rate|75.0||||1e-05|TWO_SIDED|94.211|50.1|88.5|||Poisson regression|||Case Definition 2||88.5|50.1|0.00001
71659758|NCT03982199|142833520|SUPERIORITY||Event Rate|69.8||||4e-05|TWO_SIDED|94.211|43.7|84.7|||Poisson regression|||Case Definition 3||84.7|43.7|0.00004
71659759|NCT04709835|142833622|SUPERIORITY||Difference in Adjusted Means|-0.11|STANDARD_ERROR_OF_MEAN|0.292||0.7144|TWO_SIDED|80.0|-0.49|0.27|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.27|-0.49|0.7144
71659760|NCT04709835|142833622|SUPERIORITY||Difference in Adjusted Means|0.32|STANDARD_ERROR_OF_MEAN|0.327||0.3373|TWO_SIDED|80.0|-0.11|0.74|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.74|-0.11|0.3373
71659761|NCT04709835|142833622|SUPERIORITY||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.315||0.426|TWO_SIDED|80.0|-0.66|0.16|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.16|-0.66|0.4260
71659762|NCT04709835|142833623|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|80.0|0.53|1.74|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.74|0.53|
71661280|NCT03275064|142836247|SUPERIORITY||Mean Difference (Net)|2.27|||||TWO_SIDED|90.0|-43.11|47.65|||Mixed Models Analysis|||Week 28||47.65|-43.11|
71734890|NCT04473664|142985245|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|69.9|||||TWO_SIDED|90.0|46.8|104.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for AC886.||104|46.8|
71832326|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|20.7||||0.0386|TWO_SIDED|90.0|1.5|38.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||38.8|1.5|0.0386
71734891|NCT04473664|142985248|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|44.7|||||TWO_SIDED|90.0|18.0|111.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||111|18.0|
71734892|NCT04473664|142985249|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|16.0|165.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUClast statistical comparison was analyzed for Quizartinib.||165|16.0|
71734893|NCT04473664|142985249|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|51.5|||||TWO_SIDED|90.0|15.8|168.0|||||For the comparison, the Moderate Hepatic Impairment treatment group represents the numerator and Normal Hepatic Function treatment group represents the denominator.|AUCinf statistical comparison was analyzed for Quizartinib.||168|15.8|
71734894|NCT03392649|142985253|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
71734895|NCT03392649|142985254|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
71734896|NCT03392649|142985255|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71734897|NCT03392649|142985256|SUPERIORITY|||||||0.09|||||||Fisher Exact|||||||0.09
71734898|NCT03392649|142985257|SUPERIORITY|||||||0.16|||||||Fisher Exact|||||||0.16
71734899|NCT03392649|142985258|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
71734900|NCT03392649|142985259|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71773234|NCT00395538|143046117|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.002
71889484|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-17.4||||0.03|TWO_SIDED|95.0|-33.1|-1.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-1.7|-33.1|0.030
71661281|NCT03275064|142836248|SUPERIORITY|Week 29|Mean Difference (Net)|200.18||||0.0131|TWO_SIDED|90.0|54.53|345.83|||Mixed Models Analysis|||||345.83|54.53|0.0131
71734901|NCT03392649|142985260|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71734902|NCT03927144|142985287|SUPERIORITY||Odds Ratio (OR)|6.48|||<|0.0001|TWO_SIDED|95.0|4.28|9.82|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (no. of prior prophylactic migraine treatment failures=1 vs 2) after missing data were imputed as non-response.||||9.82|4.28|<0.0001
71734903|NCT03927144|142985288|SUPERIORITY||Odds Ratio (OR)|11.27|||<|0.0001|TWO_SIDED|95.0|7.53|16.87|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||16.87|7.53|<0.0001
71889485|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-24.6||||0.003|TWO_SIDED|95.0|-41.0|-8.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-8.3|-41.0|0.003
71734904|NCT03927144|142985289|SUPERIORITY||Treatment difference|-2.13|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.74|-1.52|||Linear mixed effects model||AMG334 70 mg/140 mg vs Oral Prophylactic|Comparison of mean change from baseline in monthly migraine days at Week 52||-1.52|-2.74|<0.001
71734905|NCT03927144|142985290|SUPERIORITY||Odds Ratio (OR)|13.75|||<|0.001|TWO_SIDED|95.0|9.08|20.83|||Cochran-Mantel-Haenszel|Adjusted for number of prior prophylactic migraine treatment failures=1 vs 2 after missing data were imputed as non-response.||||20.83|9.08|<0.001
71734906|NCT01452919|142985298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.73|STANDARD_ERROR_OF_MEAN|1.25||0.17||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.170
71734907|NCT01452919|142985299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.5||0.109||95.0||||Two-sided p-value. P-value is for Week 0.5.|Type 3 sums of squares|||||||0.109
71889486|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Night 1|-19.1||||0.02|TWO_SIDED|95.0|-35.1|-3.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.0|-35.1|0.020
71659763|NCT04709835|142833623|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|80.0|0.76|2.32|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.32|0.76|
71659764|NCT04709835|142833624|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|80.0|0.44|1.7|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||1.70|0.44|
71659765|NCT04709835|142833624|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|80.0|0.56|2.03|||||Hazard ratio (80% CI) was estimated with a Cox proportional hazards model (unadjusted).|||2.03|0.56|
71659766|NCT04709835|142833625|SUPERIORITY||Difference in Percentage of Positivity|5.0|||||TWO_SIDED|80.0|-0.16|10.16|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||10.16|-0.16|
71659767|NCT04709835|142833625|SUPERIORITY||Difference in Percentage of Positivity|-1.9|||||TWO_SIDED|80.0|-9.2|5.41|||||Confidence interval estimated with the Farrington-Manning method.|Day 3||5.41|-9.20|
71659768|NCT04709835|142833625|SUPERIORITY||Difference in Percentage of Positivity|5.79|||||TWO_SIDED|80.0|-4.82|16.4|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||16.40|-4.82|
71659769|NCT04709835|142833625|SUPERIORITY||Difference in Percentage of Positivity|-0.88|||||TWO_SIDED|80.0|-12.4|10.65|||||Confidence interval estimated with the Farrington-Manning method.|Day 5||10.65|-12.40|
71659770|NCT04709835|142833625|SUPERIORITY||Difference in Percentage of Positivity|2.39|||||TWO_SIDED|80.0|-10.64|15.42|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||15.42|-10.64|
71734908|NCT01452919|142985299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.372||95.0||||Two-sided p-value. P-value is for Week 1.|Type 3 sums of squares|||||||0.372
71659771|NCT04709835|142833625|SUPERIORITY||Difference in Percentage of Positivity|-0.26|||||TWO_SIDED|80.0|-13.39|12.88|||||Confidence interval estimated with the Farrington-Manning method.|Day 7||12.88|-13.39|
71659772|NCT04709835|142833637|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.294||0.7351|TWO_SIDED|80.0|-0.48|0.28|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 3||0.28|-0.48|0.7351
71659773|NCT04709835|142833637|SUPERIORITY||Difference in Adjusted Means|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7524|TWO_SIDED|80.0|-0.5|0.3|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 5||0.30|-0.50|0.7524
71659774|NCT04709835|142833637|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.314||0.8083|TWO_SIDED|80.0|-0.48|0.33|||ANCOVA||A difference in adjusted means of \<0 favors RO7496998 (AT-527).|Day 7||0.33|-0.48|0.8083
71659775|NCT04711902|142833654|OTHER|estimation and confidence interval|Marginal difference|39.91|||||TWO_SIDED|95.0|10.87|68.95|||Regression, Logistic|||||68.95|10.87|
71659776|NCT04711902|142833655|OTHER|estimation and confidence interval|Marginal difference|11.86|||||TWO_SIDED|95.0|-7.18|30.91|||Regression, Logistic|||||30.91|-7.18|
71659777|NCT04711902|142833656|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.1|||||TWO_SIDED|95.0|-1.68|-0.52|||Mixed Models Analysis|||||-0.52|-1.68|
71659778|NCT04711902|142833657|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-1.65|||||TWO_SIDED|95.0|-2.35|-0.94|||Mixed Models Analysis|||||-0.94|-2.35|
71659779|NCT04711902|142833658|OTHER|estimation and confidence interval|Mixed model repeated scores (MMRM)|4.2|||||TWO_SIDED|95.0|0.94|7.46|||Mixed Models Analysis|||||7.46|0.94|
71659780|NCT04711902|142833659|OTHER|estimation and confidence interval|Mixed model repeated measures (MMRM)|-0.4|||||TWO_SIDED|95.0|-0.58|-0.21|||Mixed Models Analysis|||||-0.21|-0.58|
71659781|NCT04796779|142833685|SUPERIORITY||||||<|0.001|||||||Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
71659782|NCT04796779|142833686|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||<0.001
71659783|NCT04796779|142833687|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
71659784|NCT04796779|142833688|SUPERIORITY||||||<|0.001||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Direct likelihood model|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a random effect.||||||<0.001
71659785|NCT04796779|142833689|SUPERIORITY|||||||0.57||||||To preserve the overall type I error for the multiple secondary outcomes, a hierarchical gatekeeping approach was used.|Robust regression using M-estimation|The model was adjusted for the baseline value of the metric, age, prior CGM and pump use, and site as a fixed effect.||||||0.57
71659786|NCT00894738|142833838|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The null hypothesis is that mean DEXA total percent fat is similar between the two groups of interest. The primary statistical model consisted of treatment group as a 2-level factor (AP-Treated Vs Non-AP Treated) and DEXA total percent fat as a covariate. Carotid intima-media thickness (CIMT) was the dependent variable.||||0.49
71659787|NCT00894738|142833839|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The statistical analysis consisted of treatment group as a 2-level factor variable and DEXA total percent fat as a covariate. An interaction term between treatment group and DEXA total percent fat was also generated. Hepatic triglyceride content was the dependent variable. DEXA total percent fat was found to be significant while treatment group and the interaction between treatment group and DEXA total percent fat were not significant.||||<0.0001
71659788|NCT00415194|142833840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.082|TWO_SIDED|95.0|0.75|1.02|||Stratified Log Rank|||||1.02|0.75|0.082
71734909|NCT01452919|142985299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.555||95.0||||Two-sided p-value. P-value is for Week 1.5.|Type 3 sums of squares|||||||0.555
71659789|NCT00415194|142833841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.166|TWO_SIDED|95.0|0.76|1.03|||Stratified Log Rank|||||1.03|0.76|0.166
71734910|NCT01452919|142985299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.806||95.0||||Two-sided p-value. P-value is for Week 2.|Type 3 sums of squares|||||||0.806
71734911|NCT01452919|142985300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.762||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.762
71734912|NCT01452919|142985301|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.506||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.506
71734913|NCT01452919|142985302|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.515||95.0||||Two-sided p-value.|Type 3 sums of squares|||||||0.515
71734914|NCT01452919|142985305|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.966||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.966
71734915|NCT01452919|142985306|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.92|STANDARD_ERROR_OF_MEAN|0.73||0.895||95.0||||One-sided p-value.|Type 3 sums of squares|||||||0.895
71734916|NCT01192412|142985307|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.77|1.35||||||We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan-DeMets spending function with O'Brien-Fleming-type boundaries for early stopping.||1.35|0.77|
71734917|NCT01192412|142985308|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||||TWO_SIDED|95.0|0.79|3.84||||||||3.84|0.79|
71773235|NCT00395538|143046117|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.787||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.787
71832327|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|12.1||||0.1485|TWO_SIDED|90.0|-6.4|30.3|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||30.3|-6.4|0.1485
71832328|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|17.3||||0.062|TWO_SIDED|90.0|-0.8|34.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||34.8|-0.8|0.0620
71659790|NCT00415194|142833842|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Unadjusted normal distribution|p-value is based on an unadjusted, normal distribution approximation for differences in rates.||||||0.061
71734918|NCT02421588|142985309|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.6294|TWO_SIDED|95.0|0.854|1.309|||Log Rank|||PFS between treatments||1.309|0.854|0.6294
71734919|NCT02421588|142985309|SUPERIORITY||PFS at 6 months|24.3|||||TWO_SIDED|95.0|18.4|30.7|||||Percent of Participants|PFS (%) at 6 months||30.7|18.4|
71734920|NCT02421588|142985309|SUPERIORITY||PFS at 6 months|27.5|||||TWO_SIDED|95.0|20.9|34.4|||||Percent of Participants|PFS (%) at 6 months||34.4|20.9|
71832329|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|26.9||||0.0089|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||44.4|6.5|0.0089
71832330|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|37.8||||0.0005|TWO_SIDED|90.0|17.5|54.7|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.7|17.5|0.0005
71832331|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|36.7||||0.0007|TWO_SIDED|90.0|15.4|54.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||54.0|15.4|0.0007
71659791|NCT00415194|142833843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.811|TWO_SIDED|95.0|0.56|1.53|||Stratified Log Rank|||||1.53|0.56|0.811
71659792|NCT00415194|142833844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.2|TWO_SIDED|95.0|0.69|1.07|||Stratified Log Rank|||||1.07|0.69|0.20
71659793|NCT02397408|142833866|OTHER||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||||||<.008
71734921|NCT02421588|142985309|SUPERIORITY|||||||0.5032|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.5032
71734922|NCT02421588|142985309|SUPERIORITY||PFS at 12 months|8.3|||||TWO_SIDED|95.0|4.7|13.3|||||Percent of Participants|PFS (%) at 12 months||13.3|4.7|
71734923|NCT02421588|142985309|SUPERIORITY||PFS at 12 months|7.0|||||TWO_SIDED|95.0|3.3|12.5|||||Percent of Participants|PFS (%) at 12 months||12.5|3.3|
71734924|NCT02421588|142985309|SUPERIORITY|||||||0.6742|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.6742
71734925|NCT02421588|142985310|SUPERIORITY||Hazard Ratio (HR)|0.987||||0.7673|TWO_SIDED|95.0|0.805|1.209|||Log Rank|||PFS between treatments||1.209|0.805|0.7673
71734926|NCT02421588|142985310|SUPERIORITY||PFS at 6 months|29.0|||||TWO_SIDED|95.0|22.8|35.4|||||Percent of Participants|PFS (%) at 6 months||35.4|22.8|
71734927|NCT02421588|142985310|SUPERIORITY||PFS at 6 months|27.4|||||TWO_SIDED|95.0|21.3|33.9|||||Percent of Participants|PFS (%) at 6 months||33.9|21.3|
71734928|NCT02421588|142985310|SUPERIORITY|||||||0.7385|||||||Normal approximation|||PFS (%) at 6 months between treatments||||0.7385
71734929|NCT02421588|142985310|SUPERIORITY||PFS (%) at 12 months|8.2|||||TWO_SIDED|95.0|4.8|12.7|||||Percent of Participants|PFS (%) at 12 months||12.7|4.8|
71734930|NCT02421588|142985310|SUPERIORITY||PFS (%) at 12 months|7.5|||||TWO_SIDED|95.0|4.2|12.2|||||Percent of Participants|PFS (%) at 12 months||12.2|4.2|
71832332|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|18.1||||0.0711|TWO_SIDED|90.0|-2.0|37.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||37.5|-2.0|0.0711
71832333|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|23.8||||0.0266|TWO_SIDED|90.0|2.7|42.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||42.5|2.7|0.0266
71659794|NCT01524679|142833902|SUPERIORITY|The Fisher Test with asymptotic test statistic provided by the analysis software was used.|||||<|0.0001||||||This was the only a priori defined primary endpoint. There was no adjustment for multiple comparisons.|Fisher Exact|There was no adjustment for other variables intended for the primary analysis. Confounding variables were analysed in subsequent analyses.||Nullhypothesis was the equality of response rates of the treatment group and the control group. Treatments were compared by a two-sided Fisher test on a level of significance of 0.05. The study was appropriately powered (80%) for this analysis.||||<0.0001
71659795|NCT01524679|142833903|SUPERIORITY||Mean Difference (Final Values)|0.7525||||0.0957|TWO_SIDED|95.0|0.5382|1.0521|||ANCOVA|||||1.0521|0.5382|0.0957
71659796|NCT01524679|142833904|SUPERIORITY||Mean Difference (Final Values)|0.4621||||0.0005|TWO_SIDED|95.0|0.4621|0.7106|||ANCOVA|||||0.7106|0.4621|0.0005
71659797|NCT03397771|142833919|OTHER||Odds Ratio (OR)|1.0||||0.963|TWO_SIDED||||||Regression, Logistic|||||||0.963
71659798|NCT03397771|142833920|NON_INFERIORITY|The analysis was conducted according to the nul hypothesis, assuming no difference between treatment arms||||||0.022|||||||ANCOVA|||||||0.022
71659799|NCT03801265|142833921|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||.770
71659800|NCT03801265|142833922|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||.826
71659801|NCT03801265|142833923|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||.859
71734931|NCT02421588|142985310|SUPERIORITY|||||||0.8245|||||||Normal approximation|||PFS (%) at 12 months between treatments||||0.8245
71832334|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|3.8||||0.4173|TWO_SIDED|90.0|-15.3|23.1|||Chan and Zhang Exact Method|||At week 4: Risk difference = difference in percentage of participants.||23.1|-15.3|0.4173
71832335|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|16.3||||0.1096|TWO_SIDED|90.0|-4.3|35.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||35.6|-4.3|0.1096
71832336|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|27.0||||0.0133|TWO_SIDED|90.0|6.1|45.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.7|6.1|0.0133
71832337|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|23.2||||0.0304|TWO_SIDED|90.0|2.6|41.7|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||41.7|2.6|0.0304
71889487|NCT00792298|143300606|SUPERIORITY_OR_OTHER||LS Mean Difference: Week 4|-20.2||||0.019|TWO_SIDED|95.0|-37.0|-3.4|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.||-3.4|-37.0|0.019
71889488|NCT04258579|143300608|OTHER|Estimation only.|Mean value at 6 weeks|19.13|||||TWO_SIDED|95.0|15.59|22.67||||||||22.67|15.59|
71889489|NCT04258579|143300608|OTHER|Estimation only.|Mean value at 9 weeks|16.87|||||TWO_SIDED|95.0|12.5|21.24||||||||21.24|12.50|
71659802|NCT03801265|142833924|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||.904
71659803|NCT03801265|142833925|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||.122
71659804|NCT03801265|142833926|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.379|||||||Wilcoxon (Mann-Whitney)|||||||.379
71659805|NCT03801265|142833927|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.881|||||||Wilcoxon (Mann-Whitney)|||||||.881
71661282|NCT03275064|142836248|SUPERIORITY||Mean Difference (Net)|141.87||||0.0544|TWO_SIDED|90.0|-3.83|287.56|||Mixed Models Analysis|||Week 29||287.56|-3.83|0.0544
71661283|NCT03275064|142836248|SUPERIORITY||Mean Difference (Net)|228.27||||0.0067|TWO_SIDED|90.0|80.87|375.67|||Mixed Models Analysis|||Week 53||375.67|80.87|0.0067
71734932|NCT02421588|142985311|SUPERIORITY||Hazard Ratio (HR)|0.956||||0.8021|TWO_SIDED|95.0|0.772|1.183|||Log Rank|||OS between treatments||1.183|0.772|0.8021
71832338|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
71832339|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
71832340|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|1.1||||0.4966|TWO_SIDED|90.0|-18.4|20.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||20.4|-18.4|0.4966
71659806|NCT03801265|142833928|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.818|||||||Wilcoxon (Mann-Whitney)|||||||.818
71659807|NCT03801265|142833929|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.678|||||||Wilcoxon (Mann-Whitney)|||||||.678
71659808|NCT03801265|142833930|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||.002
71659809|NCT03801265|142833931|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.007|||||||Chi-squared|||||||.007
71659810|NCT03801265|142833932|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||.271
71659811|NCT03801265|142833933|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||.810
71659812|NCT03801265|142833934|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||.676
71659813|NCT03801265|142833935|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.908|||||||Wilcoxon (Mann-Whitney)|||||||.908
71773236|NCT00395538|143046118|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the year 1 biopsy.||||||0.082||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.082
71832341|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|10.9||||0.2753|TWO_SIDED|90.0|-9.3|30.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.1|-9.3|0.2753
71659814|NCT03801265|142833936|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||.270
71734933|NCT02421588|142985311|SUPERIORITY||OS at 12 months|48.2|||||TWO_SIDED|95.0|41.3|54.8|||||Percent of Participants|OS (%) at 12 months||54.8|41.3|
71734934|NCT02421588|142985311|SUPERIORITY||OS (%) at 12 months|45.3|||||TWO_SIDED|95.0|38.4|52.0|||||Percent of Participants|OS (%) at 12 months||52.0|38.4|
71734935|NCT02421588|142985311|SUPERIORITY|||||||0.5515|||||||Normal approximation|||OS (%) at 12 months between treatments||||0.5515
71734936|NCT02421588|142985311|SUPERIORITY||OS (%) at 24 months|22.3|||||TWO_SIDED|95.0|16.8|28.2|||||Percent of Participants|OS (%) at 24 months||28.2|16.8|
71832342|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|16.2||||0.1036|TWO_SIDED|90.0|-4.2|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-4.2|0.1036
71659815|NCT03801265|142833937|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
71659816|NCT03801265|142833938|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||.203
71734937|NCT02421588|142985311|SUPERIORITY||OS (%) at 24 months|22.7|||||TWO_SIDED|95.0|17.1|28.7|||||Percent of Participants|OS (%) at 24 months||28.7|17.1|
71734938|NCT02421588|142985311|SUPERIORITY|||||||0.9253|||||||Normal approximation|||OS (%) at 24 months between treatments||||0.9253
71734939|NCT02421588|142985312|SUPERIORITY||ORR|14.5|||||TWO_SIDED|95.0|10.1|19.8|||||Percent of Participants|Overall response rate||19.8|10.1|
71734940|NCT02421588|142985312|SUPERIORITY||ORR|12.7|||||TWO_SIDED|95.0|8.6|17.8|||||Percent of Participants|Overall response rate||17.8|8.6|
71734941|NCT02421588|142985312|SUPERIORITY|||||||0.6772|||||||Fisher Exact|||Overall response rate between treatments||||0.6772
71734942|NCT02421588|142985313|SUPERIORITY||ORR|15.8|||||TWO_SIDED|95.0|11.3|21.3|||||Percent of Participants|Overall response rate (ORR)||21.3|11.3|
71659817|NCT03801265|142833939|NON_INFERIORITY|The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||.672
71659818|NCT04078126|142833940|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0179||0.345|TWO_SIDED|95.0|-0.054|0.02|||ANCOVA|||||0.020|-0.054|0.3450
71659819|NCT04078126|142833941|OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.0183||0.3675|TWO_SIDED|95.0|-0.054|0.021|||ANCOVA|||||0.021|-0.054|0.3675
71659820|NCT04078126|142833942|OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0199||0.7563|TWO_SIDED|95.0|-0.047|0.034|||ANCOVA|||||0.034|-0.047|0.7563
71659821|NCT04078126|142833943|OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.0521||0.5419|TWO_SIDED|95.0|-0.139|0.075|||ANCOVA|||||0.075|-0.139|0.5419
71659822|NCT04078126|142833944|OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|2.334||0.1337|TWO_SIDED|95.0|-8.39|1.18|||ANCOVA|||||1.18|-8.39|0.1337
71659823|NCT04078126|142833945|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.269||0.0431|TWO_SIDED|95.0|-5.29|-0.09|||ANCOVA|||||-0.09|-5.29|0.0431
71659824|NCT04078126|142833946|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.667||0.3625|TWO_SIDED|95.0|-4.87|1.81|||ANCOVA|||||1.81|-4.87|0.3625
71659825|NCT04078126|142833947|OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.0198||0.0375|TWO_SIDED|95.0|0.003|0.084|||ANCOVA|||||0.084|0.003|0.0375
71659826|NCT04078126|142833948|OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.0443||0.9089|TWO_SIDED|95.0|-0.086|0.096|||ANCOVA|||||0.096|-0.086|0.9089
71659827|NCT00886288|142833998|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71659828|NCT01675661|142834018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.985|TWO_SIDED|95.0|0.63|1.59|||Regression, Logistic|OR=1.00||For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.||1.59|0.63|0.985
71659829|NCT02393248|142834031|SUPERIORITY|||||||0.2841|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2841
71659830|NCT02393248|142834031|SUPERIORITY|||||||0.3042|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.3042
71889490|NCT04258579|143300608|OTHER|Estimation only.|Mean value at 12 weeks|15.0|||||TWO_SIDED|95.0|11.24|18.76||||||||18.76|11.24|
71659831|NCT02393248|142834031|SUPERIORITY|||||||0.1259|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.1259
71659832|NCT02393248|142834031|SUPERIORITY|||||||0.8214|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8214
71659833|NCT02393248|142834031|SUPERIORITY|||||||0.4315|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.4315
71659834|NCT02393248|142834031|SUPERIORITY|||||||0.2595|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.2595
71659835|NCT02393248|142834035|SUPERIORITY|||||||0.8577|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.8577
71659836|NCT02393248|142834035|SUPERIORITY|||||||0.7238|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7238
71659837|NCT02393248|142834035|SUPERIORITY|||||||0.5923|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5923
71659838|NCT02393248|142834035|SUPERIORITY|||||||0.7634|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.7634
71659839|NCT02393248|142834035|SUPERIORITY|||||||0.5749|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.5749
71659840|NCT02393248|142834035|SUPERIORITY|||||||0.6877|||||||ANOVA|1-factor ANOVA of log-transformed, dose-normalized data (factor = dose)||||||0.6877
71659841|NCT02393248|142834039|SUPERIORITY|||||||0.143|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.143
71659842|NCT02393248|142834040|SUPERIORITY|||||||0.0013|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.0013
71659843|NCT02393248|142834041|SUPERIORITY|||||||0.319|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.319
71659844|NCT02393248|142834042|SUPERIORITY|||||||0.128|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.128
71659845|NCT02393248|142834043|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
71659846|NCT02393248|142834044|SUPERIORITY|||||||0.305|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.305
71659847|NCT02393248|142834045|SUPERIORITY|||||||0.772|||||||ANOVA|crossover ANOVA of log-transformed data||||||0.772
71659848|NCT01971970|142834087|EQUIVALENCE|The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.|||||<|0.05|||||||Paired t-test,FDR 1.5fold,FDRvalue≤ 0.05|||The number of genes with a 1.5 fold change (FDR value ≤ 0.05; paired t-test) from week 0 to week 8 were assessed for pediatric IBD or adult IBD patients.||||< 0.05
71659849|NCT01971970|142834088|OTHER|||||||0.2616||||||Kaplan-Meier curve comparing the percentage of children and adults on continued anti-TNF therapy over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding continued anti-TNF therapy, reflecting maintenance of response at 12 and 18 months.||||0.2616
71659850|NCT01971970|142834089|OTHER|||||||0.0177||||||Kaplan-Meier curve comparing the percentage of children and adults with therapy intensification over the course of study duration|gehan-breslow-wilcoxon test|||Kaplan-Meier curves were produced by dividing the population in the following groups i) paediatric versus adult patients.These groups were used to statistically compare the proportions of patients over time regarding the escalation of anti-TNF therapy (dose increase above 5 mg/kg and/or interval shortening to less than 8 weeks)||||0.0177
71661284|NCT03275064|142836248|SUPERIORITY||Mean Difference (Net)|116.21||||0.0931|TWO_SIDED|90.0|-29.52|261.94|||Mixed Models Analysis|||Week 53||261.94|-29.52|0.0931
71889491|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.1|||||TWO_SIDED|95.0|19.7|24.5||||||||24.50|19.70|
71659851|NCT01783548|142834124|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.66||||0.002|TWO_SIDED|95.0|-1.08|-0.24||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.24|-1.08|0.002
71659852|NCT01783548|142834125|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.58||||0.004|TWO_SIDED|95.0|-0.99|-0.18||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.18|-0.99|0.004
71659853|NCT01783548|142834126|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.62||||0.002|TWO_SIDED|95.0|-1.0|-0.23||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.23|-1.00|0.002
71659854|NCT01783548|142834127|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.54||||0.004|TWO_SIDED|95.0|-0.91|-0.17||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.17|-0.91|0.004
71659855|NCT00988442|142834128|SUPERIORITY_OR_OTHER|||||||1||||||Two-sided 5% significance level.|Fisher Exact|||A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.||||1.000
71659856|NCT00117325|142834171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.335||||0.05|TWO_SIDED|95.0|-0.67|0.0|||ANCOVA|Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.67|0.050
71659857|NCT00117325|142834172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.027|TWO_SIDED|95.0|-0.74|-0.05||Week 1-4|ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.05|-0.74|0.027
71659858|NCT00117325|142834173|SUPERIORITY_OR_OTHER|||||||0.184|||||||Regression, Logistic|logistic regression adjusting for age, gender, investigator, and treatment.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.|Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.|||0.184
71659859|NCT00117325|142834174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.051|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.00|-0.70|0.051
71659860|NCT00117325|142834175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.304||||0.076|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis||0.03|-0.64|0.076
71659861|NCT00117325|142834176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.51||||0.093|TWO_SIDED|95.0|-9.77|0.75|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||0.75|-9.77|0.093
71659862|NCT00117325|142834177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.372||||0.023|TWO_SIDED|95.0|-11.8|-0.9|||ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.||-0.90|-11.8|0.023
71659863|NCT00117325|142834178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.118||||0.061|TWO_SIDED|95.0|-0.24|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.01|-0.24|0.061
71659864|NCT00117325|142834178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.061|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion||0.01|-0.25|0.061
71832343|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|20.6||||0.0457|TWO_SIDED|90.0|0.4|39.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||39.6|0.4|0.0457
71659865|NCT00117325|142834178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.095||||0.138|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.03|-0.22|0.138
71659866|NCT00117325|142834179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.113||||0.087|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.02|-0.24|0.087
71659867|NCT00117325|142834179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||-0.03|-0.30|0.015
71659868|NCT00117325|142834179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.112||||0.106|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.25|0.106
71659869|NCT00117325|142834180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.132||||0.048|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea||-0.00|-0.26|0.048
71659870|NCT00117325|142834180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.076|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion||0.01|-0.26|0.076
71661285|NCT03275064|142836249|SUPERIORITY||Mean Difference (Net)|0.05||||0.0574|TWO_SIDED|90.0|0.0|0.1|||Mixed Models Analysis|||Week 29||0.10|-0.00|0.0574
71889492|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|19.9|||||TWO_SIDED|95.0|18.0|21.8||||||||21.80|18.00|
71659871|NCT00117325|142834180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.164|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip||0.04|-0.22|0.164
71659872|NCT00117325|142834181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.136|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea||0.03|-0.22|0.136
71659873|NCT00117325|142834181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1||95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion||0.02|-0.24|0.100
71659874|NCT00117325|142834181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.1|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip||0.02|-0.24|0.100
71659875|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.011|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1||-0.10|-0.80|0.011
71659876|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.325||||0.089|TWO_SIDED|95.0|-0.7|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2||0.05|-0.70|0.089
71659877|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.393||||0.052|TWO_SIDED|95.0|-0.79|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3||0.00|-0.79|0.052
71659878|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.187|TWO_SIDED|95.0|-0.65|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4||0.13|-0.65|0.187
71659879|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.298||||0.164|TWO_SIDED|95.0|-0.72|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5||0.12|-0.72|0.164
71659880|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.573||||0.008|TWO_SIDED|95.0|-1.0|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6||-0.15|-1.00|0.008
71659881|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.376||||0.082|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7||0.05|-0.80|0.082
71659882|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.296|TWO_SIDED|95.0|-0.67|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8||0.20|-0.67|0.296
71659883|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.191||||0.383|TWO_SIDED|95.0|-0.62|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9||0.24|-0.62|0.383
71659884|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.048|TWO_SIDED|95.0|-0.92|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10||-0.00|-0.92|0.048
71734943|NCT02421588|142985313|SUPERIORITY||Overall response rate (ORR)|16.7|||||TWO_SIDED|95.0|12.1|22.3|||||Percent of Participants|Overall response rate (ORR)||22.3|12.1|
71734944|NCT02421588|142985313|SUPERIORITY|||||||0.8976|||||||Fisher Exact|||Overall response rate (ORR) between treatments||||0.8976
71889493|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|8.93|||||TWO_SIDED|95.0|7.68|10.18||||||||10.18|7.68|
71659885|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.172||||0.469|TWO_SIDED|95.0|-0.64|0.29|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11||0.29|-0.64|0.469
71659886|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.151|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12||0.12|-0.80|0.151
71659887|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.344||||0.145|TWO_SIDED|95.0|-0.81|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13||0.12|-0.81|0.145
71659888|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.297|TWO_SIDED|95.0|-0.68|0.21|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14||0.21|-0.68|0.297
71659889|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.094|TWO_SIDED|95.0|-0.82|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15||0.07|-0.82|0.094
71659890|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.064|TWO_SIDED|95.0|-0.89|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16||0.03|-0.89|0.064
71661286|NCT03275064|142836249|SUPERIORITY||Mean Difference (Net)|0.06||||0.0248|TWO_SIDED|90.0|0.01|0.11|||Mixed Models Analysis|||Week 29||0.11|0.01|0.0248
71734945|NCT02421588|142985314|SUPERIORITY||Hazard Ratio (HR)|1.406||||0.2631|TWO_SIDED|95.0|0.769|2.569|||Log Rank|||Duration of response between treatments||2.569|0.769|0.2631
71734946|NCT02421588|142985315|SUPERIORITY|Duration of response between treatments|Hazard Ratio (HR)|1.056||||0.8276|TWO_SIDED|95.0|0.64|1.743|||Log Rank|||||1.743|0.64|0.8276
71659891|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.563||||0.019|TWO_SIDED|95.0|-1.03|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17||-0.09|-1.03|0.019
71659892|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.457||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18||-0.01|-0.90|0.044
71734947|NCT02421588|142985316|SUPERIORITY||ORR (%)|26.6|||||TWO_SIDED|95.0|20.2|33.8|||||Percent of Participants|ORR (%) by CA-125||33.8|20.2|
71734948|NCT02421588|142985316|SUPERIORITY||ORR (%)|19.4|||||TWO_SIDED|95.0|13.7|26.3|||||Percent of Participants|ORR (%) by CA-125||26.3|13.7|
71734949|NCT02421588|142985316|SUPERIORITY|||||||0.1231|||||||Fisher Exact|||ORR (%) by CA-125 between treatments||||0.1231
71734950|NCT03194646|142985344|OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-2.44|-1.26||||||||-1.26|-2.44|
71773237|NCT00395538|143046118|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the years 2 and 4 (combined) biopsy.||||||0.057||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.057
71773238|NCT00395538|143046118|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.547||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.547
71773239|NCT00395538|143046119|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the baseline and the year 1 biopsy.||||||0.922||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.922
71773240|NCT00395538|143046119|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 and the years 2 and 4 (combined) biopsy.||||||0.342||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.342
71773241|NCT00395538|143046119|OTHER|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.449||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.||||0.449
71832344|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
71832345|NCT03903822|143168976|SUPERIORITY||Risk Difference (RD)|29.4||||0.0078|TWO_SIDED|90.0|7.2|47.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||47.6|7.2|0.0078
71832346|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|3.3||||0.245|TWO_SIDED|90.0|-5.4|14.9|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.9|-5.4|0.2450
71832347|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|3.1||||0.2575|TWO_SIDED|90.0|-5.3|14.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||14.0|-5.3|0.2575
71659893|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.633||||0.007|TWO_SIDED|95.0|-1.09|-0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19||-0.17|-1.09|0.007
71659894|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.348|TWO_SIDED|95.0|-0.69|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20||0.24|-0.69|0.348
71734951|NCT03194646|142985344|OTHER||Mean Difference (Final Values)|-2.34|||||TWO_SIDED|95.0|-2.87|-1.8||||||||-1.80|-2.87|
71734952|NCT03194646|142985344|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-2.51|-1.1||||||||-1.10|-2.51|
71734953|NCT04071158|142985375|SUPERIORITY||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.4|2.8||||||Difference in percentage||2.8|-1.4|
71734954|NCT04071158|142985376|SUPERIORITY||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-4.6|1.7||||||Difference in percentage||1.7|-4.6|
71734955|NCT04071158|142985377|SUPERIORITY||Ratio of Geometric Mean|0.8|||||TWO_SIDED|95.0|0.64|1.0||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||1.00|0.64|
71659895|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.281||||0.243|TWO_SIDED|95.0|-0.76|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21||0.19|-0.76|0.243
71734956|NCT04071158|142985377|SUPERIORITY||Ratio of Geometric Mean|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.70|0.50|
71832348|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|16.1||||0.0087|TWO_SIDED|90.0|5.7|31.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||31.0|5.7|0.0087
71832349|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|10.7||||0.0392|TWO_SIDED|90.0|0.8|25.4|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.4|0.8|0.0392
71889494|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|26.63|||||TWO_SIDED|95.0|24.32|28.94||||||||28.94|24.32|
71734957|NCT04071158|142985377|SUPERIORITY||Ratio of Geometric Mean|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Anti-PT: Ratio of geometric mean was calculated by dividing the GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm.||0.76|0.48|
71734958|NCT04071158|142985378|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% confidence interval (CI) from the ratio of titers with 50 percent cut off from two treatment groups greater than (\>) 0.5.||1.13|0.84|
71734959|NCT04071158|142985379|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|2.0-fold margin (related to primary objective): primary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.5.||1.14|0.81|
71734960|NCT04071158|142985384|SUPERIORITY||Ratio of Geometric Mean|0.97|||||TWO_SIDED|95.0|0.84|1.13|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.13|0.84|
71734961|NCT04071158|142985385|SUPERIORITY||Ratio of Geometric Mean|0.96|||||TWO_SIDED|95.0|0.81|1.14|||||Ratio of geometric mean was calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm.|1.5-fold margin (related to secondary objective): secondary objective was demonstrated if the lower limit of 95% CI from the ratio of titers with 50 percent cut off from two treatment groups \> 0.67.||1.14|0.81|
71734962|NCT01178099|142985390|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.05|||||TWO_SIDED|90.0|0.829|1.33|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.33|0.829|
71734963|NCT01178099|142985390|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.895|||||TWO_SIDED|90.0|0.718|1.12|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||1.12|0.718|
71734964|NCT01178099|142985390|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.905|||||TWO_SIDED|90.0|0.656|1.25|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD.|||1.25|0.656|
71734965|NCT01178099|142985391|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.953|||||TWO_SIDED|90.0|0.664|1.37|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall).|||1.37|0.664|
71734966|NCT01178099|142985391|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.612|||||TWO_SIDED|90.0|0.436|0.86|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD.|||0.860|0.436|
71832350|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-11.2|11.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||11.2|-11.2|1.0000
71889495|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 9 weeks, Domain 1|22.53|||||TWO_SIDED|95.0|19.87|25.23||||||||25.23|19.87|
71889496|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 9 weeks, Domain 2|21.0|||||TWO_SIDED|95.0|18.87|23.13||||||||23.13|18.87|
71889497|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 9 weeks, Domain 3|8.69|||||TWO_SIDED|95.0|7.39|9.99||||||||9.99|7.39|
71889498|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 9 weeks, Domain 4|27.38|||||TWO_SIDED|95.0|25.07|29.69||||||||29.69|25.07|
71659896|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595||||0.014|TWO_SIDED|95.0|-1.07|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22||-0.12|-1.07|0.014
71659897|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.474||||0.055|TWO_SIDED|95.0|-0.96|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23||0.01|-0.96|0.055
71659898|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.464||||0.062|TWO_SIDED|95.0|-0.95|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24||0.02|-0.95|0.062
71659899|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43||||0.079|TWO_SIDED|95.0|-0.91|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25||0.05|-0.91|0.079
71659900|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.576||||0.019|TWO_SIDED|95.0|-1.06|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26||-0.10|-1.06|0.019
71659901|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.056|TWO_SIDED|95.0|-0.97|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27||0.01|-0.97|0.056
71659902|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.659||||0.018|TWO_SIDED|95.0|-1.2|-0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28||-0.11|-1.20|0.018
71659903|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222||||0.194|TWO_SIDED|95.0|-0.56|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1||0.1|-0.56|0.194
71659904|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.263||||0.134|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2||0.08|-0.61|0.134
71734967|NCT01178099|142985391|SUPERIORITY_OR_OTHER||Geometric LS Means, SCD:Healthy|1.03|||||TWO_SIDED|90.0|0.625|1.68|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD.|||1.68|0.625|
71734968|NCT01178099|142985392|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.070
71734969|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.52|||||TWO_SIDED|90.0|1.1|2.1|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.10|1.10|
71734970|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.44|||||TWO_SIDED|90.0|1.06|1.94|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.94|1.06|
71734971|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.43|||||TWO_SIDED|90.0|0.918|2.21|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||2.21|0.918|
71889499|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 12 weeks, Domain 1|22.62|||||TWO_SIDED|95.0|20.18|25.06||||||||25.06|20.18|
71889500|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 12 weeks, Domain 2|21.58|||||TWO_SIDED|95.0|19.84|23.32||||||||23.32|19.84|
71889501|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 12 weeks, Domain 3|9.19|||||TWO_SIDED|95.0|7.92|10.46||||||||10.46|7.92|
71659905|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.091|TWO_SIDED|95.0|-0.67|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3||0.05|-0.67|0.091
71659906|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278||||0.131|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4||0.08|-0.64|0.131
71659907|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.483|TWO_SIDED|95.0|-0.49|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5||0.23|-0.49|0.483
71659908|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.137|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6||0.10|-0.70|0.137
71659909|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.142|TWO_SIDED|95.0|-0.69|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7||0.10|-0.69|0.142
71659910|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.22|TWO_SIDED|95.0|-0.64|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8||0.15|-0.64|0.220
71661287|NCT03275064|142836249|SUPERIORITY||Mean Difference (Net)|0.01||||0.3864|TWO_SIDED|90.0|-0.05|0.07|||Mixed Models Analysis|||Week 53||0.07|-0.05|0.3864
71734972|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.971|||||TWO_SIDED|90.0|0.742|1.27|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite.|||1.27|0.742|
71889502|NCT04258579|143300609|OTHER|Estimation only.|Mean value at 12 weeks, Domain 4|27.81|||||TWO_SIDED|95.0|25.53|30.09||||||||30.09|25.53|
71889503|NCT04258579|143300610|OTHER|Estimation only.|Mean value at baseline|22.45|||||TWO_SIDED|95.0|19.56|25.34||||||||25.34|19.56|
71832351|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|7.8||||0.1528|TWO_SIDED|90.0|-4.9|22.5|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||22.5|-4.9|0.1528
71832352|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|0.9||||0.4989|TWO_SIDED|90.0|-12.7|15.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||15.2|-12.7|0.4989
71832353|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|0.3||||0.5419|TWO_SIDED|90.0|-13.6|14.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||14.2|-13.6|0.5419
71832354|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
71832355|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|15.9||||0.0541|TWO_SIDED|90.0|-0.4|33.9|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||33.9|-0.4|0.0541
71832356|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|3.3||||0.3945|TWO_SIDED|90.0|-12.0|19.5|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||19.5|-12.0|0.3945
71832357|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|23.3||||0.0201|TWO_SIDED|90.0|3.9|41.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||41.8|3.9|0.0201
71832358|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|11.2||||0.1372|TWO_SIDED|90.0|-5.4|28.2|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||28.2|-5.4|0.1372
71832359|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|3.5||||0.3924|TWO_SIDED|90.0|-11.6|19.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||19.1|-11.6|0.3924
71832360|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|20.1||||0.0311|TWO_SIDED|90.0|2.4|38.3|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.3|2.4|0.0311
71832361|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|20.0||||0.0392|TWO_SIDED|90.0|0.8|38.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||38.1|0.8|0.0392
71889504|NCT04258579|143300610|OTHER|Estimation only.|Mean value at 6 weeks|20.53|||||TWO_SIDED|95.0|17.65|23.41||||||||23.41|17.65|
71889505|NCT04258579|143300611|OTHER|Estimation only.|Mean value at baseline, Domain 1|19.89|||||TWO_SIDED|95.0|17.24|22.54||||||||22.54|17.24|
71889506|NCT04258579|143300611|OTHER|Estimation only.|Mean value at baseline, Domain 2|22.46|||||TWO_SIDED|95.0|19.72|25.2||||||||25.20|19.72|
71889507|NCT04258579|143300611|OTHER|Estimation only.|Mean value at baseline, Domain 3|16.0|||||TWO_SIDED|95.0|13.72|18.28||||||||18.28|13.72|
71889508|NCT04258579|143300611|OTHER|Estimation only.|Mean value at baseline, Domain 4|17.79|||||TWO_SIDED|95.0|15.34|20.24||||||||20.24|15.34|
71889509|NCT04258579|143300611|OTHER|Estimation only.|Mean value at 6 weeks, Domain 1|22.79|||||TWO_SIDED|95.0|19.05|26.53||||||||26.53|19.05|
71889510|NCT04258579|143300611|OTHER|Estimation only.|Mean value at 6 weeks, Domain 2|26.7|||||TWO_SIDED|95.0|22.96|30.44||||||||30.44|22.96|
71889511|NCT04258579|143300611|OTHER|Estimation only.|Mean value at 6 weeks, Domain 3|17.45|||||TWO_SIDED|95.0|14.57|20.33||||||||20.33|14.57|
71889512|NCT04258579|143300611|OTHER|Estimation only.|Mean value at 6 weeks, Domain 4|20.69|||||TWO_SIDED|95.0|18.23|23.15||||||||23.15|18.23|
71889513|NCT02388295|143300612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.24||0.13|ONE_SIDED|||||Not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline within treatment arm||||0.13
71889514|NCT02388295|143300612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.25||0.91|ONE_SIDED|||||not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline||||0.91
71889515|NCT02388295|143300612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.68|ONE_SIDED||||||ANOVA|no adjustments|larger negagtive values (powereed to detect -0.50)|Change from baseline||||0.68
71889516|NCT02388295|143300612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.34||0.32|TWO_SIDED|||||no adjustment|ANOVA||Looking for negative direction to indicate treatment better than placebo|Secondary objective - comparison to placebo||||0.32
71889517|NCT02388295|143300612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.36||0.45|TWO_SIDED|||||no adjustment|ANOVA||lookin for negative difference compared to placebo|Secondary objective||||0.45
71889518|NCT02076165|143300615|SUPERIORITY||||||=|0.12|||||||Fisher Exact|||Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.||||=.120
71889519|NCT02076165|143300616|SUPERIORITY||Mean Difference (Final Values)|-0.711|STANDARD_ERROR_OF_MEAN|3.59|=|0.843|TWO_SIDED|95.0|-7.75|6.32|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual bed time. Negative values indicate the number of minutes earlier than the recommended bed time that the participant went to bed, indicating greater non-adherence.|||6.32|-7.75|=.843
71889520|NCT02076165|143300617|SUPERIORITY||Mean Difference (Final Values)|-2.78|STANDARD_ERROR_OF_MEAN|5.17|=|0.59|TWO_SIDED|95.0|-12.91|7.35|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual rise time. Positive values indicate the number of minutes later than the recommended rise time that the participant got out of bed, indicating greater non-adherence.|||7.35|-12.91|=0.590
71889521|NCT02076165|143300618|SUPERIORITY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.048|=|0.979|TWO_SIDED|95.0|-0.093|0.096|||Mixed Models Analysis||The proportion of nights participants who did not follow the recommendation to get out of bed if awake more than 20 minutes. Higher numbers indicate greater non-adherence.|||0.096|-0.093|=0.979
71889522|NCT02076165|143300619|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.409|STANDARD_ERROR_OF_MEAN|2.02|=|0.004|TWO_SIDED|90.0|-2.92|3.74|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||3.74|-2.92|=0.004
71659911|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.081|TWO_SIDED|95.0|-0.79|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9||0.05|-0.79|0.081
71659912|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.453||||0.034|TWO_SIDED|95.0|-0.87|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10||-0.04|-0.87|0.034
71734973|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.815|||||TWO_SIDED|90.0|0.633|1.05|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 7.5 mg MD for the R-106583 metabolite.|||1.05|0.633|
71734974|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.952|||||TWO_SIDED|90.0|0.658|1.38|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for the 5 mg MD for the R-106583 metabolite.|||1.38|0.658|
71734975|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.17|||||TWO_SIDED|90.0|0.833|1.65|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.65|0.833|
71773242|NCT01074047|143046152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0829|TWO_SIDED|95.0|0.69|1.02|||Log Rank|The p-value is two-sided from an unstratified log-rank test|The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.02|0.69|0.0829
71773243|NCT01074047|143046152|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1009|TWO_SIDED|95.0|0.69|1.03|||Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.|||1.03|0.69|0.1009
71734976|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.07|||||TWO_SIDED|90.0|0.779|1.48|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.48|0.779|
71734977|NCT01178099|142985393|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.813|||||TWO_SIDED|95.0|0.51|1.3|||Mixed Models Analysis|Log(AUC) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.30|0.510|
71734978|NCT01178099|142985394|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.018
71734979|NCT01178099|142985395|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
71734980|NCT01178099|142985396|SUPERIORITY_OR_OTHER|||||||0.219||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.219
71734981|NCT01178099|142985397|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.177
71773244|NCT01074047|143046153|SUPERIORITY_OR_OTHER||Difference|12.26|||||TWO_SIDED|95.0|3.5|21.0|||||Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.|||21.0|3.5|
71773245|NCT01074047|143046154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1495|TWO_SIDED|95.0|0.72|1.05|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of EFS||1.05|0.72|0.1495
71773246|NCT01074047|143046155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.5832|TWO_SIDED|95.0|0.75|1.66|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of RFS||1.66|0.75|0.5832
71832362|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|10.0||||0.1541|TWO_SIDED|90.0|-6.2|26.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||26.4|-6.2|0.1541
71773247|NCT01074047|143046156|SUPERIORITY_OR_OTHER|||||||0.5384|||||||Fisher Exact|P-value is from Fishers exact test||||||0.5384
71659913|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.314||||0.15|TWO_SIDED|95.0|-0.74|0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11||0.11|-0.74|0.150
71661288|NCT03275064|142836249|SUPERIORITY||Mean Difference (Net)|0.02||||0.329|TWO_SIDED|90.0|-0.05|0.08|||Mixed Models Analysis|||Week 53||0.08|-0.05|0.3290
71734982|NCT01178099|142985398|SUPERIORITY_OR_OTHER|||||||0.168||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.168
71734983|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.5|||||TWO_SIDED|90.0|1.01|2.22|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.|||2.22|1.01|
71773248|NCT01074047|143046158|SUPERIORITY_OR_OTHER|||||||0.0376|||||||Fisher Exact|P-value is from Fishers exact test||||||0.0376
71773249|NCT01074047|143046182|SUPERIORITY_OR_OTHER||Relative Ratio|0.79||||0.0721|TWO_SIDED|95.0|0.62|1.02|||negative binomial regression analysis|||||1.02|0.62|0.0721
71773250|NCT03052764|143046192|SUPERIORITY||Least Squares Mean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.561|<|0.0001|TWO_SIDED|95.0|-3.68|-1.46|||ANCOVA|||||-1.46|-3.68|<.0001
71773251|NCT03052764|143046193|SUPERIORITY||Odds Ratio (OR)|6.15|||||TWO_SIDED|95.0|0.75|50.37|||||Values obtained were from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes)at each scheduled visit.|||50.37|0.75|
71773252|NCT03052764|143046194|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.534|<|0.0001|TWO_SIDED|95.0|-3.3|-1.18|||ANCOVA|||||-1.18|-3.30|<.0001
71832363|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
71832364|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|8.5||||0.2835|TWO_SIDED|90.0|-9.5|27.0|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.0|-9.5|0.2835
71659914|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.333||||0.111|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12||0.08|-0.74|0.111
71659915|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.261|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13||0.19|-0.69|0.261
71659916|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.123|TWO_SIDED|95.0|-0.78|0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14||0.09|-0.78|0.123
71659917|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.415||||0.056|TWO_SIDED|95.0|-0.84|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15||0.01|-0.84|0.056
71659918|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.566||||0.011|TWO_SIDED|95.0|-1.0|-0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16||-0.13|-1.00|0.011
71659919|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.009|TWO_SIDED|95.0|-1.03|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17||-0.15|-1.03|0.009
71659920|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.301||||0.175|TWO_SIDED|95.0|-0.74|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18||0.13|-0.74|0.175
71659921|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.449||||0.039|TWO_SIDED|95.0|-0.87|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19||-0.02|-0.87|0.039
71659922|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.315||||0.152|TWO_SIDED|95.0|-0.75|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20||0.12|-0.75|0.152
71659923|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.424||||0.063|TWO_SIDED|95.0|-0.87|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21||0.02|-0.87|0.063
71659924|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.454||||0.044|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22||-0.01|-0.90|0.044
71659925|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.312||||0.179|TWO_SIDED|95.0|-0.77|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23||0.14|-0.77|0.179
71734984|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.09|||||TWO_SIDED|90.0|0.751|1.58|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-95913 metabolite.|||1.58|0.751|
71734985|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.87|||||TWO_SIDED|90.0|1.09|3.2|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-95913 metabolite.|||3.20|1.09|
71734986|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.873|||||TWO_SIDED|90.0|0.66|1.15|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite.|||1.15|0.660|
71659926|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.479||||0.034|TWO_SIDED|95.0|-0.92|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24||-0.04|-0.92|0.034
71659927|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.157||||0.505|TWO_SIDED|95.0|-0.62|0.31|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25||0.31|-0.62|0.505
71659928|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.317||||0.186|TWO_SIDED|95.0|-0.79|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26||0.15|-0.79|0.186
71659929|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.283||||0.234|TWO_SIDED|95.0|-0.75|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27||0.18|-0.75|0.234
71659930|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.645||||0.017|TWO_SIDED|95.0|-1.17|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28||-0.12|-1.17|0.017
71659931|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.095|TWO_SIDED|95.0|-0.7|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1||0.06|-0.70|0.095
71659932|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.236|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2||0.15|-0.61|0.236
71659933|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.255||||0.205|TWO_SIDED|95.0|-0.65|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3||0.14|-0.65|0.205
71773253|NCT03052764|143046195|SUPERIORITY||Least Squares Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-3.73|-1.39|||ANCOVA|||||-1.39|-3.73|<.0001
71773254|NCT03052764|143046196|SUPERIORITY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.192||0.0004|TWO_SIDED|95.0|-1.09|-0.32|||ANCOVA|||||-0.32|-1.09|0.0004
71773255|NCT03052764|143046197|SUPERIORITY||Odds Ratio (OR)|13.03|||||TWO_SIDED|95.0|3.23|52.57|||||Values were obtained from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) at each scheduled visit.|||52.57|3.23|
71889523|NCT02076165|143300620|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.757|STANDARD_ERROR_OF_MEAN|2.12||0.003|TWO_SIDED|90.0|-2.72|4.23|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||4.23|-2.72|.003
71889524|NCT02076165|143300621|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|90.0|-1.21|2.57|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||2.57|-1.21|<0.001
71889525|NCT02076165|143300622|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|90.0|-1.14|3.36|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||3.36|-1.14|<.001
71889526|NCT02076165|143300623|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|0.501|STANDARD_ERROR_OF_MEAN|0.9|=|0.048|TWO_SIDED|90.0|-0.98|1.98|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.|||1.98|-0.98|=0.048
71889527|NCT02076165|143300624|NON_INFERIORITY|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|1.06|=|0.008|TWO_SIDED|90.0|-2.32|1.17|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.|||1.17|-2.32|=0.008
71889528|NCT01850615|143300651|SUPERIORITY_OR_OTHER||Treatment difference|-0.94|||||TWO_SIDED|95.0|-1.17|-0.72|||||Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (faster aspart+basal minus basal only), which was calculated using the FAS, was below 0%.|Change from baseline in HbA1c after 18 weeks of treatment was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits 16, 22 and 28 were included in the analysis. This model included treatment, region and strata as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||-0.72|-1.17|
71889529|NCT01375764|143300677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.94|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-44.08|-27.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-27.80|-44.08|<0.001
71889530|NCT01375764|143300677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.82|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.97|-19.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-19.67|-35.97|<0.001
71889531|NCT01375764|143300677|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Tretament Difference|-26.01|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-34.08|-17.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-17.93|-34.08|<0.001
71773256|NCT03332771|143046231|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% confidence interval (CI) for the adjusted mean difference is \<0.3.|Difference in Least Squares (LS) Mean|0.12|STANDARD_ERROR_OF_MEAN|0.122||0.3306|TWO_SIDED|95.0|-0.12|0.357|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.357|-0.120|0.3306
71773257|NCT03332771|143046231|NON_INFERIORITY|The non-inferiority hypothesis was declared significant if the upper bound of the 2-sided 95% CI for the adjusted mean difference is \<0.3.|Difference in LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7112|TWO_SIDED|95.0|-0.265|0.181|||ANCOVA|||The change from baseline to Week 52 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.181|-0.265|0.7112
71661289|NCT03275064|142836250|SUPERIORITY||Mean Difference (Net)|4.75||||0.6184|TWO_SIDED|90.0|-21.36|30.85|||Mixed Models Analysis|||Week 16||30.85|-21.36|0.6184
71659934|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.084|TWO_SIDED|95.0|-0.73|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4||0.05|-0.73|0.084
71659935|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.146||||0.475|TWO_SIDED|95.0|-0.55|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5||0.26|-0.55|0.475
71659936|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296||||0.178|TWO_SIDED|95.0|-0.73|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6||0.14|-0.73|0.178
71659937|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.406||||0.071|TWO_SIDED|95.0|-0.85|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7||0.04|-0.85|0.071
71659938|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.111||||0.621|TWO_SIDED|95.0|-0.55|0.33|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8||0.33|-0.55|0.621
71734987|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.681|||||TWO_SIDED|90.0|0.524|0.886|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-106583 metabolite.|||0.886|0.524|
71773258|NCT03332771|143046232|SUPERIORITY||Difference in LS Mean|-0.21|STANDARD_ERROR_OF_MEAN|0.119||0.0827|TWO_SIDED|95.0|-0.44|0.027|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||0.027|-0.440|0.0827
71659939|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.372|TWO_SIDED|95.0|-0.66|0.25|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9||0.25|-0.66|0.372
71659940|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.452||||0.046|TWO_SIDED|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10||-0.01|-0.90|0.046
71659941|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.302||||0.183|TWO_SIDED|95.0|-0.75|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11||0.14|-0.75|0.183
71734988|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.898|||||TWO_SIDED|90.0|0.612|1.32|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-106583 metabolite.|||1.32|0.612|
71734989|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.06|||||TWO_SIDED|90.0|0.773|1.46|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.|||1.46|0.773|
71734990|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|0.785|||||TWO_SIDED|90.0|0.582|1.06|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 7.5 mg MD for the R-119251 metabolite.|||1.06|0.582|
71773259|NCT03332771|143046232|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.103||0.0003|TWO_SIDED|95.0|-0.571|-0.167|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.167|-0.571|0.0003
71773260|NCT03332771|143046233|SUPERIORITY||Difference in LS Mean|-1.49|STANDARD_ERROR_OF_MEAN|0.349|<|0.0001|TWO_SIDED|95.0|-2.173|-0.803|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups (placebo, sotagliflozin 200 mg, sotagliflozin 400 mg, glimepiride), randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of SBP (\<130,≥ 130 mmHg) at screening, and country as fixed effects, and baseline body weight as a covariate.||-0.803|-2.173|<0.0001
71832365|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|9.9||||0.27|TWO_SIDED|90.0|-8.7|27.8|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||27.8|-8.7|0.2700
71659942|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.226||||0.32|TWO_SIDED|95.0|-0.67|0.22|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12||0.22|-0.67|0.320
71659943|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.188||||0.431|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13||0.28|-0.66|0.431
71659944|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.191|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14||0.15|-0.75|0.191
71659945|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.475||||0.043|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15||-0.02|-0.94|0.043
71661290|NCT03275064|142836250|OTHER||Mean Difference (Net)|-7.32||||0.3194|TWO_SIDED|90.0|-33.16|18.53|||Mixed Models Analysis|||Week 28||18.53|-33.16|0.3194
71734991|NCT01178099|142985399|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means, SCD:Healthy|1.0|||||TWO_SIDED|90.0|0.648|1.55|||Mixed Models Analysis|Log(Cmax) = Participant + Population + Dose + Population\*Dose + Random Error|This is the estimated value for 5 mg MD for the R-119251 metabolite.|||1.55|0.648|
71832366|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|17.3||||0.0662|TWO_SIDED|90.0|-1.4|36.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.2|-1.4|0.0662
71832367|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
71889532|NCT01375764|143300678|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.29|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED|95.0|-53.73|-40.84||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab + ezetimibe and ezetimibe alone, and the alternative hypothesis was that a mean difference did exist.||-40.84|-53.73|<0.001
71659946|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.619||||0.009|TWO_SIDED|95.0|-1.08|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16||-0.16|-1.08|0.009
71659947|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.495||||0.04|TWO_SIDED|95.0|-0.97|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17||-0.02|-0.97|0.040
71659948|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262||||0.249|TWO_SIDED|95.0|-0.71|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18||0.18|-0.71|0.249
71659949|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.536||||0.023|TWO_SIDED|95.0|-1.0|-0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19||-0.07|-1.00|0.023
71659950|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.321|TWO_SIDED|95.0|-0.71|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20||0.23|-0.71|0.321
71659951|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.568||||0.019|TWO_SIDED|95.0|-1.04|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21||-0.09|-1.04|0.019
71659952|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.419||||0.092|TWO_SIDED|95.0|-0.91|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22||0.07|-0.91|0.092
71659953|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.206||||0.404|TWO_SIDED|95.0|-0.69|0.28|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23||0.28|-0.69|0.404
71734992|NCT01178099|142985400|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.060
71734993|NCT01178099|142985401|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for PRI by flow cytometry. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.086
71734994|NCT01178099|142985401|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error|ANCOVA|||||||0.679
71734995|NCT01178099|142985402|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||This is the p-value for AU\*min to 6.5 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.396
71734996|NCT01178099|142985402|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||This is the p-value for AU\*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.288
71889533|NCT01375764|143300679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-94.9|-58.3||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-58.3|-94.9|<0.001
71659954|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.546||||0.027|TWO_SIDED|95.0|-1.03|-0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24||-0.06|-1.03|0.027
71659955|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.227||||0.357|TWO_SIDED|95.0|-0.71|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25||0.26|-0.71|0.357
71659956|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.403||||0.114|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26||0.10|-0.90|0.114
71659957|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.307||||0.228|TWO_SIDED|95.0|-0.81|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27||0.19|-0.81|0.228
71734997|NCT01178099|142985402|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||This is the p-value for AU\*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.095
71734998|NCT01178099|142985402|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||This is the p-value for AU\*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.086
71889534|NCT01375764|143300679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.5|STANDARD_ERROR_OF_MEAN|9.3|<|0.001|TWO_SIDED|95.0|-74.0|-37.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-37.1|-74.0|<0.001
71659958|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.725||||0.012|TWO_SIDED|95.0|-1.29|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28||-0.16|-1.29|0.012
71889535|NCT01375764|143300679|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.6|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-70.8|-34.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-34.5|-70.8|<0.001
71889536|NCT01375764|143300680|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-91.9|STANDARD_ERROR_OF_MEAN|8.4|<|1|TWO_SIDED|95.0|-108.7|-75.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-75.0|-108.7|<0001
71889537|NCT01375764|143300681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.6|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-40.93|-26.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-26.28|-40.93|<0.001
71889538|NCT01375764|143300681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.66|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-33.99|-19.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-19.32|-33.99|<0.001
71889539|NCT01375764|143300681|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-24.86|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-32.13|-17.59||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.59|-32.13|<0.001
71889540|NCT01375764|143300682|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-50.81|-39.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-39.18|-50.81|<0.001
71832368|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|20.0||||0.0302|TWO_SIDED|90.0|2.2|38.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||38.3|2.2|0.0302
71832369|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|27.0||||0.0091|TWO_SIDED|90.0|6.8|45.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||45.4|6.8|0.0091
71832370|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|11.8||||0.1561|TWO_SIDED|90.0|-6.5|30.2|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||30.2|-6.5|0.1561
71832371|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|16.2||||0.0753|TWO_SIDED|90.0|-2.7|34.8|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||34.8|-2.7|0.0753
71832372|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|27.0||||0.0108|TWO_SIDED|90.0|5.7|46.0|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||46.0|5.7|0.0108
71832373|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|31.8||||0.005|TWO_SIDED|90.0|9.2|50.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||50.4|9.2|0.0050
71889541|NCT01375764|143300683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Teatment Difference|-29.88|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-36.84|-22.92||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-22.92|-36.84|<0.001
71889542|NCT01375764|143300683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.13|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-29.1|-15.16||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.16|-29.10|<0.001
71889543|NCT01375764|143300683|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.38|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|-28.29|-14.48||Testing based on a signficance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-14.48|-28.29|<0.001
71734999|NCT01178099|142985403|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.083
71735000|NCT01178099|142985404|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment\*Population + Random Error.|ANCOVA|||||||0.124
71832374|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|16.7||||0.0775|TWO_SIDED|90.0|-2.9|35.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||35.7|-2.9|0.0775
71832375|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|24.1||||0.0243|TWO_SIDED|90.0|3.4|43.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||43.4|3.4|0.0243
71832376|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|20.9||||0.0234|TWO_SIDED|90.0|3.5|38.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||38.8|3.5|0.0234
71832377|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|12.8||||0.1134|TWO_SIDED|90.0|-2.8|29.3|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.3|-2.8|0.1134
71889544|NCT01375764|143300684|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.23|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.81|-32.64||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.64|-43.81|<0.001
71832378|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|10.3||||0.1362|TWO_SIDED|90.0|-5.0|26.2|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||26.2|-5.0|0.1362
71832379|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|12.3||||0.1029|TWO_SIDED|90.0|-3.4|29.8|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||29.8|-3.4|0.1029
71832380|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-17.9|17.9|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||17.9|-17.9|1.0000
71832381|NCT03903822|143168977|SUPERIORITY||Risk Difference (RD)|-12.6||||0.8972|TWO_SIDED|90.0|-28.8|3.5|||Chan and Zhang Exact Method|||At follow-up visit: Risk difference = difference in percentage of participants.||3.5|-28.8|0.8972
71889545|NCT01375764|143300685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.95|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-37.56|-24.34||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-24.34|-37.56|<0.001
71889546|NCT01375764|143300685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.91|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-30.53|-17.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-17.29|-30.53|<0.001
71889547|NCT01375764|143300685|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.36|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-28.92|-15.8||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-15.80|-28.92|<0.001
71889548|NCT01375764|143300686|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|-43.77|-32.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-32.07|-43.77|<0.001
71889549|NCT01375764|143300687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.05|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-40.57|-27.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-27.52|-40.57|<0.001
71832382|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|8.33||0.4781|TWO_SIDED|90.0|-14.2|13.3|||Mixed Model Repeated Measure|||At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||13.3|-14.2|0.4781
71832383|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-13.8|STANDARD_ERROR_OF_MEAN|8.47||0.0522|TWO_SIDED|90.0|-27.8|0.2|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.2|-27.8|0.0522
71832384|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-17.5|STANDARD_ERROR_OF_MEAN|8.37||0.0187|TWO_SIDED|90.0|-31.4|-3.7|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-3.7|-31.4|0.0187
71832385|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-20.6|STANDARD_ERROR_OF_MEAN|8.45||0.008|TWO_SIDED|90.0|-34.5|-6.6|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-6.6|-34.5|0.0080
71832386|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-25.0|STANDARD_ERROR_OF_MEAN|14.17||0.0401|TWO_SIDED|90.0|-48.6|-1.5|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.5|-48.6|0.0401
71832387|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-25.5|STANDARD_ERROR_OF_MEAN|14.25||0.0379|TWO_SIDED|90.0|-49.2|-1.9|||Mixed Model Repeated Measure|||At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-1.9|-49.2|0.0379
71832388|NCT03903822|143168978|SUPERIORITY||LS Mean difference|8.1|STANDARD_ERROR_OF_MEAN|11.01||0.7678|TWO_SIDED|90.0|-10.1|26.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||26.3|-10.1|0.7678
71832389|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-22.8|STANDARD_ERROR_OF_MEAN|10.94||0.0193|TWO_SIDED|90.0|-40.9|-4.7|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-4.7|-40.9|0.0193
71832390|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-28.3|STANDARD_ERROR_OF_MEAN|10.95||0.0052|TWO_SIDED|90.0|-46.5|-10.2|||Mixed Model Repeated Measure|||At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.2|-46.5|0.0052
71832391|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-23.7|STANDARD_ERROR_OF_MEAN|11.03||0.0164|TWO_SIDED|90.0|-42.0|-5.5|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-5.5|-42.0|0.0164
71832392|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-31.7|STANDARD_ERROR_OF_MEAN|9.72||0.0008|TWO_SIDED|90.0|-47.8|-15.6|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-47.8|0.0008
71832393|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-40.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.0001|TWO_SIDED|90.0|-57.0|-24.3|||Mixed Model Repeated Measure|||At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-24.3|-57.0|<0.0001
71832394|NCT03903822|143168978|SUPERIORITY||LS Mean difference|3.9|STANDARD_ERROR_OF_MEAN|12.09||0.6269|TWO_SIDED|90.0|-16.1|23.9|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||23.9|-16.1|0.6269
71832395|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.87||0.0027|TWO_SIDED|90.0|-53.1|-13.8|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-13.8|-53.1|0.0027
71832396|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-38.8|STANDARD_ERROR_OF_MEAN|11.89||0.0007|TWO_SIDED|90.0|-58.5|-19.2|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.2|-58.5|0.0007
71832397|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-32.1|STANDARD_ERROR_OF_MEAN|12.0||0.0041|TWO_SIDED|90.0|-51.9|-12.3|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.9|0.0041
71832398|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-14.6|STANDARD_ERROR_OF_MEAN|11.61||0.1054|TWO_SIDED|90.0|-33.9|4.6|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||4.6|-33.9|0.1054
71832399|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-18.8|STANDARD_ERROR_OF_MEAN|11.62||0.0542|TWO_SIDED|90.0|-38.1|0.5|||Mixed Model Repeated Measure|||At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||0.5|-38.1|0.0542
71832400|NCT03903822|143168978|SUPERIORITY||LS Mean difference|5.8|STANDARD_ERROR_OF_MEAN|12.12||0.6847|TWO_SIDED|90.0|-14.2|25.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||25.9|-14.2|0.6847
71832401|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-29.9|STANDARD_ERROR_OF_MEAN|11.82||0.0062|TWO_SIDED|90.0|-49.4|-10.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-10.3|-49.4|0.0062
71832402|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-32.0|STANDARD_ERROR_OF_MEAN|11.89||0.004|TWO_SIDED|90.0|-51.6|-12.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-12.3|-51.6|0.0040
71832403|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-30.8|STANDARD_ERROR_OF_MEAN|11.97||0.0054|TWO_SIDED|90.0|-50.6|-11.0|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-11.0|-50.6|0.0054
71832404|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.35||0.1076|TWO_SIDED|90.0|-27.2|3.9|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.9|-27.2|0.1076
71889550|NCT01375764|143300687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-33.35|-20.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-20.27|-33.35|<0.001
71832405|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-23.0|STANDARD_ERROR_OF_MEAN|9.42||0.0082|TWO_SIDED|90.0|-38.6|-7.3|||Mixed Model Repeated Measure|||At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-7.3|-38.6|0.0082
71832406|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-17.8|STANDARD_ERROR_OF_MEAN|14.14||0.1051|TWO_SIDED|90.0|-41.2|5.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||5.6|-41.2|0.1051
71832407|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-37.8|STANDARD_ERROR_OF_MEAN|13.8||0.0034|TWO_SIDED|90.0|-60.6|-15.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.0|-60.6|0.0034
71832408|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-41.9|STANDARD_ERROR_OF_MEAN|13.83||0.0014|TWO_SIDED|90.0|-64.8|-19.0|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-19.0|-64.8|0.0014
71832409|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-38.6|STANDARD_ERROR_OF_MEAN|13.9||0.003|TWO_SIDED|90.0|-61.6|-15.6|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-15.6|-61.6|0.0030
71832410|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-17.7|STANDARD_ERROR_OF_MEAN|9.22||0.0289|TWO_SIDED|90.0|-33.0|-2.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.||-2.4|-33.0|0.0289
71659959|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.093||||0.643|TWO_SIDED|95.0|-0.49|0.3|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1||0.30|-0.49|0.643
71659960|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279||||0.15|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2||0.10|-0.66|0.150
71832411|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-33.8|STANDARD_ERROR_OF_MEAN|9.27||0.0002|TWO_SIDED|90.0|-49.2|-18.4|||Mixed Model Repeated Measure|||At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-18.4|-49.2|0.0002
71889551|NCT01375764|143300687|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.1|STANDARD_ERROR_OF_MEAN|3.27|<|0.001|TWO_SIDED|95.0|-31.57|-18.62||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|||-18.62|-31.57|<0.001
71889552|NCT01375764|143300688|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.25|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.99|-35.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|||-35.50|-46.99|<0.001
71889553|NCT01194440|143300696|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Bonferonni|Adjusting for multiple comparisons in the analyses, a Bonferonni-corrected p-value of 0.05/5 = 0.01 to represent statistical significance was used.||The primary hypothesis of the study is that administration of zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS compared to letrozole treatment alone (historical control).||||<0.001
71889554|NCT00896532|143300703|SUPERIORITY||LS Mean Difference from Placebo|8.7|||<|0.0001|TWO_SIDED|95.0|7.5|9.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.9|7.5|< 0.0001
71832412|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|13.88||0.4739|TWO_SIDED|90.0|-23.9|22.0|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||22.0|-23.9|0.4739
71832413|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-19.1|STANDARD_ERROR_OF_MEAN|13.43||0.0789|TWO_SIDED|90.0|-41.3|3.2|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||3.2|-41.3|0.0789
71832414|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-13.4|STANDARD_ERROR_OF_MEAN|13.5||0.1611|TWO_SIDED|90.0|-35.7|8.9|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||8.9|-35.7|0.1611
71832415|NCT03903822|143168978|SUPERIORITY||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|13.94||0.0124|TWO_SIDED|90.0|-54.7|-8.5|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||-8.5|-54.7|0.0124
71832416|NCT03903822|143168978|SUPERIORITY||LS Mean difference|-5.3|STANDARD_ERROR_OF_MEAN|17.68||0.3828|TWO_SIDED|90.0|-34.7|24.1|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||24.1|-34.7|0.3828
71832417|NCT03903822|143168978|SUPERIORITY||LS Mean difference|1.7|STANDARD_ERROR_OF_MEAN|17.8||0.5383|TWO_SIDED|90.0|-27.9|31.3|||Mixed Model Repeated Measure|||At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.||31.3|-27.9|0.5383
71832418|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|-5.4||||0.8964|TWO_SIDED|90.0|-16.1|2.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||2.0|-16.1|0.8964
71659961|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291||||0.162|TWO_SIDED|95.0|-0.7|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3||0.12|-0.70|0.162
71659962|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.244||||0.242|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4||0.17|-0.65|0.242
71735001|NCT02516592|142985405|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.028|TWO_SIDED|95.0|0.005|0.084|||Mixed Models Analysis|||||0.084|0.005|0.028
71735002|NCT02516592|142985406|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.063|TWO_SIDED|95.0|-0.03|0.94|||Mixed Models Analysis|||||0.94|-0.03|0.063
71735003|NCT02516592|142985407|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.002|TWO_SIDED|95.0|0.037|0.167|||Mixed Models Analysis|||||0.167|0.037|0.002
71735004|NCT02516592|142985408|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.319|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||||0.4|-1.3|0.319
71735005|NCT02516592|142985409|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.662|TWO_SIDED|95.0|-0.2|0.13|||Mixed Models Analysis|||||0.13|-0.20|0.662
71735006|NCT00510744|142985423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|24.0|<|0.05|TWO_SIDED||||||t-test, 2 sided|||paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)||||<0.05
71735007|NCT00651625|142985452|SUPERIORITY_OR_OTHER||non-applicable|||||0.05|TWO_SIDED||||||t-test, 2 sided|||group comparisons using t-test and confidence intervals.||||0.05
71735008|NCT04018313|142985460|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|105.62|||||TWO_SIDED|90.0|95.91|116.31||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||116.31|95.91|
71735009|NCT04018313|142985460|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax|Ratio of geometric least square means|98.72|||||TWO_SIDED|90.0|89.76|108.58||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.58|89.76|
71773261|NCT03332771|143046233|SUPERIORITY||Difference in LS Mean|-3.58|STANDARD_ERROR_OF_MEAN|0.544|<|0.0001|TWO_SIDED|95.0|-4.651|-2.517|||ANCOVA|||The change from baseline to Week 52 is analyzed using analysis of ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects and baseline body weight as a covariate.||-2.517|-4.651|< 0.0001
71773262|NCT03332771|143046234|SUPERIORITY||Difference in LS Mean|-4.18|STANDARD_ERROR_OF_MEAN|1.288||0.0012|TWO_SIDED|95.0|-6.701|-1.65|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-1.650|-6.701|0.0012
71773263|NCT03332771|143046234|SUPERIORITY||Difference in LS Mean|-2.7|STANDARD_ERROR_OF_MEAN|0.0973||0.0973|TWO_SIDED|95.0|-5.89|0.491|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.491|-5.890|0.0973
71832419|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|14.0||||0.0391|TWO_SIDED|90.0|1.0|28.2|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||28.2|1.0|0.0391
71832420|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-10.8|10.8|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||10.8|-10.8|1.0000
71735010|NCT04018313|142985460|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|93.47|||||TWO_SIDED|90.0|85.09|102.68||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||102.68|85.09|
71735011|NCT04018313|142985461|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|104.0|||||TWO_SIDED|90.0|94.96|113.89||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.89|94.96|
71832421|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|11.3||||0.0708|TWO_SIDED|90.0|-1.4|25.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||25.0|-1.4|0.0708
71832422|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|13.9||||0.0122|TWO_SIDED|90.0|4.7|27.0|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||27.0|4.7|0.0122
71661291|NCT03275064|142836251|SUPERIORITY||Mean Difference (Net)|3.38|||||TWO_SIDED|90.0|-1.72|8.47|||Mixed Models Analysis|||Week 29||8.47|-1.72|
71832423|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|21.6||||0.0016|TWO_SIDED|90.0|11.0|35.6|||Chan and Zhang Exact Method|||At Week 1: Risk difference = difference in percentage of participants.||35.6|11.0|0.0016
71832424|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|2.7||||0.395|TWO_SIDED|90.0|-9.8|16.1|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||16.1|-9.8|0.3950
71832425|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|19.7||||0.0173|TWO_SIDED|90.0|4.2|35.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||35.6|4.2|0.0173
71832426|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|16.2||||0.0327|TWO_SIDED|90.0|1.4|31.0|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||31.0|1.4|0.0327
71659963|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.223||||0.278|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5||0.18|-0.63|0.278
71659964|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.282||||0.2|TWO_SIDED|95.0|-0.71|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6||0.15|-0.71|0.200
71659965|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.164||||0.456|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7||0.27|-0.60|0.456
71659966|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.076|TWO_SIDED|95.0|-0.81|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8||0.04|-0.81|0.076
71659967|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.396||||0.084|TWO_SIDED|95.0|-0.85|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9||0.05|-0.85|0.084
71659968|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.481||||0.04|TWO_SIDED|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10||-0.02|-0.94|0.040
71659969|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.405||||0.09|TWO_SIDED|95.0|-0.87|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11||0.06|-0.87|0.090
71659970|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.432||||0.06|TWO_SIDED|95.0|-0.88|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12||0.02|-0.88|0.060
71659971|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.277||||0.252|TWO_SIDED|95.0|-0.75|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13||0.20|-0.75|0.252
71659972|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.229|TWO_SIDED|95.0|-0.79|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14||0.19|-0.79|0.229
71659973|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.373||||0.109|TWO_SIDED|95.0|-0.83|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15||0.08|-0.83|0.109
71659974|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.484|||||TWO_SIDED|95.0|-0.96|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16||-0.01|-0.96|
71735012|NCT04018313|142985461|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|99.3|||||TWO_SIDED|90.0|90.79|108.61||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||108.61|90.79|
71773264|NCT03332771|143046235|SUPERIORITY||Difference in LS Mean|-4.02|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-5.73|-2.319|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, and country as fixed effects, and baseline SBP as a covariate.||-2.319|-5.730|<0.0001
71773265|NCT03332771|143046236|SUPERIORITY||Percentage difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.67|-11.12|||Cochran-Mantel-Haenszel|||Weighted average of percentage difference between treatment groups from each stratum \[randomization strata of HbA1c \[≤8.5%, \>8.5%\] at screening, randomization strata of mean SBP \[\<130, ≥130 mmHg\] at screening using Cochran-Mantel-Haenszel weights.||-11.12|-19.67|<0.0001
71659975|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.003|TWO_SIDED|95.0|-1.17|-0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17||-0.23|-1.17|0.003
71659976|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.326||||0.182|TWO_SIDED|95.0|-0.81|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18||0.15|-0.81|0.182
71659977|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.299||||0.194|TWO_SIDED|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19||0.15|-0.75|0.194
71659978|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.348||||0.129|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20||0.10|-0.80|0.129
71659979|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.292||||0.232|TWO_SIDED|95.0|-0.77|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21||0.19|-0.77|0.232
71659980|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.499||||0.042|TWO_SIDED|95.0|-0.98|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22||-0.02|-0.98|0.042
71659981|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.356||||0.15|TWO_SIDED|95.0|-0.84|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23||0.13|-0.84|0.150
71659982|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.398||||0.09|TWO_SIDED|95.0|-0.86|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24||0.06|-0.86|0.090
71659983|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.909|TWO_SIDED|95.0|-0.52|0.46|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25||0.46|-0.52|0.909
71659984|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.233||||0.354|TWO_SIDED|95.0|-0.73|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26||0.26|-0.73|0.354
71832427|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|30.8||||0.0011|TWO_SIDED|90.0|13.2|46.6|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||46.6|13.2|0.0011
71832428|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|11.1||||0.1348|TWO_SIDED|90.0|-5.0|27.2|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||27.2|-5.0|0.1348
71832429|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|18.5||||0.0328|TWO_SIDED|90.0|1.5|34.8|||Chan and Zhang Exact Method|||At Week 2: Risk difference = difference in percentage of participants.||34.8|1.5|0.0328
71832430|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|10.8||||0.0769|TWO_SIDED|90.0|-1.8|24.4|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||24.4|-1.8|0.0769
71832431|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|30.7||||0.0005|TWO_SIDED|90.0|13.2|46.0|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||46.0|13.2|0.0005
71889555|NCT00896532|143300703|SUPERIORITY||LS Mean Difference from placebo|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||6.9|4.3|< 0.0001
71773266|NCT01557894|143046299|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
71832432|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|37.8|||<|0.0001|TWO_SIDED|90.0|22.1|53.1|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||53.1|22.1|<0.0001
71659985|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.245|TWO_SIDED|95.0|-0.78|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27||0.20|-0.78|0.245
71659986|NCT00117325|142834182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.601||||0.038|TWO_SIDED|95.0|-1.17|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28||-0.03|-1.17|0.038
71659987|NCT01974440|142834183|SUPERIORITY||Hazard Ratio (HR)|0.806||||0.0922|TWO_SIDED|95.0|0.626|1.037|||Log Rank|||||1.037|0.626|0.0922
71659988|NCT01974440|142834184|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.4505|TWO_SIDED|95.0|0.312|1.682|||Log Rank|||||1.682|0.312|0.4505
71659989|NCT06354998|142834213|OTHER||Geometric Mean Ratio (GMR)|0.908|||||TWO_SIDED|95.0|0.662|1.245|||||GMR was a secondary endpoint.|GMR (mRNA-1273.815 versus licensed Spikevax) at Day 15 and its 95% CI was calculated based on the t-distribution for the mean difference of log-transformed antibody values and then back transformed to the original scale for presentation.||1.245|0.662|
71659990|NCT01948986|142834216|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.07|||||TWO_SIDED|90.0|80.32|132.27|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.27|80.32|
71661292|NCT03275064|142836251|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|90.0|-5.22|5.01|||Mixed Models Analysis|||Week 29||5.01|-5.22|
71773267|NCT01557894|143046300|SUPERIORITY_OR_OTHER||||||<|0.01|ONE_SIDED|95.0||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor||||||<0.01
71773268|NCT01557894|143046301|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.||||||<0.01
71773269|NCT01557894|143046302|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
71773270|NCT01557894|143046303|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
71832433|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|36.3||||0.0001|TWO_SIDED|90.0|19.7|51.8|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||51.8|19.7|0.0001
71832434|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-16.5|16.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||16.5|-16.5|1.0000
71832435|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|23.8||||0.0173|TWO_SIDED|90.0|4.5|41.5|||Chan and Zhang Exact Method|||At Week 3: Risk difference = difference in percentage of participants.||41.5|4.5|0.0173
71889556|NCT00896532|143300703|SUPERIORITY||LS Mean Difference from Placebo|7.4|||<|0.0001|TWO_SIDED|95.0|6.1|8.7||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||8.7|6.1|< 0.0001
71889557|NCT00896532|143300703|SUPERIORITY||LS Mean Difference from Placebo|8.5|||<|0.0001|TWO_SIDED|95.0|7.3|9.8||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.||9.8|7.3|< 0.0001
71659991|NCT01948986|142834216|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|156.34|||||TWO_SIDED|90.0|127.83|191.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||191.23|127.83|
71659992|NCT01948986|142834216|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|170.04|||||TWO_SIDED|90.0|139.02|207.98|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||207.98|139.02|
71659993|NCT01948986|142834216|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|155.26|||||TWO_SIDED|90.0|124.38|193.8|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||193.80|124.38|
71659994|NCT01948986|142834217|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|103.42|||||TWO_SIDED|90.0|80.66|132.61|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||132.61|80.66|
71773271|NCT04123665|143046304|SUPERIORITY||Mean Difference (Net)|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.04|||ANCOVA|Analysis of Covariance (ANCOVA) with factors for treatment group and gender, and the baseline whole mouth mean BI and whole mouth MGI as covariates.|Difference is first named treatment (experimental) minus second named treatment (control).|||-0.04|-0.11|<0.0001
71659995|NCT01948986|142834217|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|151.63|||||TWO_SIDED|90.0|124.05|185.34|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||185.34|124.05|
71659996|NCT01948986|142834217|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|168.11|||||TWO_SIDED|90.0|137.53|205.49|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||205.49|137.53|
71659997|NCT01948986|142834217|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|151.8|||||TWO_SIDED|90.0|121.69|189.36|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||189.36|121.69|
71659998|NCT01948986|142834219|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|101.57|||||TWO_SIDED|90.0|78.83|130.87|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||130.87|78.83|
71659999|NCT01948986|142834219|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|143.74|||||TWO_SIDED|90.0|117.15|176.37|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||176.37|117.15|
71660000|NCT01948986|142834219|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|140.37|||||TWO_SIDED|90.0|114.4|172.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||172.23|114.40|
71660001|NCT01948986|142834219|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|90.18|||||TWO_SIDED|90.0|71.99|112.96|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||112.96|71.99|
71660002|NCT01948986|142834226|SUPERIORITY_OR_OTHER||Ratio (Heathy Normal/T2DM Normal)|80.39|||||TWO_SIDED|90.0|59.41|108.76|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||108.76|59.41|
71660003|NCT01948986|142834226|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./Pooled Norm.)|53.46|||||TWO_SIDED|90.0|41.64|68.63|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||68.63|41.64|
71660004|NCT01948986|142834226|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./Pooled Norm.)|43.45|||||TWO_SIDED|90.0|33.85|55.78|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||55.78|33.85|
71660005|NCT01948986|142834226|SUPERIORITY_OR_OTHER||Ratio (Severe Renal Impair./Pooled Norm.|29.02|||||TWO_SIDED|90.0|22.04|38.21|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.|||38.21|22.04|
71660006|NCT01948986|142834243|SUPERIORITY_OR_OTHER||Ratio: Mild Ren. Impa./T2DM Norm. Renal|76.73|||||TWO_SIDED|95.0|48.58|121.19|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||121.19|48.58|
71660007|NCT01948986|142834243|SUPERIORITY_OR_OTHER||Ratio: Mod. Ren. Impa./T2DM Norm. Renal|86.52|||||TWO_SIDED|95.0|54.78|136.65|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||136.65|54.78|
71660008|NCT01948986|142834243|SUPERIORITY_OR_OTHER||Ratio: Sev. Ren. Impa./T2DM Norm. Renal|72.74|||||TWO_SIDED|95.0|44.63|118.58|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.|||118.58|44.63|
71660009|NCT01948986|142834245|SUPERIORITY_OR_OTHER||Ratio (Mild Renal Impair./T2DM Norm. Ren|49.75|||||TWO_SIDED|90.0|27.22|90.93|||||The model was an ANOVA model with renal function group as a fixed effect.|||90.93|27.22|
71660010|NCT01948986|142834245|SUPERIORITY_OR_OTHER||Ratio (Mod. Renal Impair./T2DM Norm. Ren|38.1|||||TWO_SIDED|90.0|20.85|69.64|||||The model was an ANOVA model with renal function group as a fixed effect.|||69.64|20.85|
71660011|NCT01948986|142834245|SUPERIORITY_OR_OTHER||Ratio (Sev. Renal Impair./T2DM Norm. Ren|13.95|||||TWO_SIDED|90.0|7.32|26.58|||||The model was an ANOVA model with renal function group as a fixed effect.|||26.58|7.32|
71660012|NCT02283983|142834298|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71660013|NCT01791153|142834318|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|42.0|||<|0.0001|TWO_SIDED|99.5|18.0|66.0|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to \[\</=\] 30 mg/day, greater than \[\>\] 30 mg/day).||66.00|18.00|<0.0001
71735013|NCT04018313|142985461|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|95.48|||||TWO_SIDED|90.0|87.36|104.37||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||104.37|87.36|
71773272|NCT02237911|143046313|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.071|TWO_SIDED|98.3|-4.9|0.7|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.7|-4.9|0.071
71832436|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5663|TWO_SIDED|90.0|-19.9|14.2|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||14.2|-19.9|0.5663
71660014|NCT01791153|142834318|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|39.06|||<|0.0001|TWO_SIDED|99.5|12.46|65.66|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||65.66|12.46|< 0.0001
71660015|NCT01791153|142834319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||< 0.0001
71661293|NCT03275064|142836251|SUPERIORITY||Mean Difference (Net)|-1.14|||||TWO_SIDED|90.0|-6.42|4.15|||Mixed Models Analysis|||Week 53||4.15|-6.42|
71661294|NCT03275064|142836251|SUPERIORITY||Mean Difference (Net)|-7.44|||||TWO_SIDED|90.0|-12.68|-2.2|||Mixed Models Analysis|||Week 53||-2.20|-12.68|
71832437|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|14.6||||0.1243|TWO_SIDED|90.0|-3.8|32.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||32.6|-3.8|0.1243
71832438|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|18.9||||0.046|TWO_SIDED|90.0|-0.5|36.6|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||36.6|-0.5|0.0460
71832439|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|25.7||||0.013|TWO_SIDED|90.0|4.8|43.3|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||43.3|4.8|0.0130
71832440|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|13.9||||0.1194|TWO_SIDED|90.0|-4.2|31.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||31.4|-4.2|0.1194
71832441|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|26.4||||0.0097|TWO_SIDED|90.0|6.5|44.4|||Chan and Zhang Exact Method|||At Week 4: Risk difference = difference in percentage of participants.||44.4|6.5|0.0097
71832442|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5556|TWO_SIDED|90.0|-21.0|16.1|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||16.1|-21.0|0.5556
71832443|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|17.6||||0.0761|TWO_SIDED|90.0|-2.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|-2.5|0.0761
71832444|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|18.9||||0.0583|TWO_SIDED|90.0|-0.8|37.6|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||37.6|-0.8|0.0583
71832445|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|14.9||||0.1245|TWO_SIDED|90.0|-5.0|33.7|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||33.7|-5.0|0.1245
71832446|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|19.4||||0.0382|TWO_SIDED|90.0|1.5|36.5|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||36.5|1.5|0.0382
71832447|NCT03903822|143168979|SUPERIORITY||Risk Difference (RD)|34.7||||0.0011|TWO_SIDED|90.0|13.2|51.4|||Chan and Zhang Exact Method|||At Week 6: Risk difference = difference in percentage of participants.||51.4|13.2|0.0011
71832448|NCT00895531|143169005|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71832449|NCT01195883|143169006|SUPERIORITY||Risk Ratio (RR)|0.9||||0.51|TWO_SIDED|95.0|0.65|1.23|||GEE model|||||1.23|0.65|0.51
71832450|NCT01195883|143169007|SUPERIORITY||Risk Ratio (RR)|0.95||||0.42|TWO_SIDED|95.0|0.81|1.11|||Chi-squared|||||1.11|0.81|0.42
71832451|NCT01195883|143169008|SUPERIORITY||Risk Ratio (RR)|0.89||||0.26|TWO_SIDED|95.0|0.72|1.09|||Chi-squared|||||1.09|0.72|0.26
71832452|NCT01195883|143169009|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4|TWO_SIDED|95.0|0.69|2.58|||Chi-squared|||||2.58|0.69|0.40
71832453|NCT02253537|143169027|EQUIVALENCE|2 x 2 contingency table with 95% CI.|2 x 2 contingency table|86.7|||||TWO_SIDED|95.0|62.1|96.3||||||||96.3|62.1|
71832454|NCT04470375|143169031|OTHER|Paired samples pre-post t-test||||||0.137|||||||t-test, 2 sided|||||||.137
71832455|NCT04470375|143169032|OTHER|Paired samples t-test (pre - post measure of group)||||||0.01|||||||t-test, 2 sided|||||||.010
71832456|NCT04470375|143169033|OTHER|Paired samples t-test (pre post measure of group)||||||0.591|||||||t-test, 2 sided|||||||.591
71832457|NCT03337399|143169039|NON_INFERIORITY|Non-inferiority of stepped PC was established if the lower one-sided 95% confidence limit for the estimated difference in means was greater than the pre-specified margin of -4.5 points, which corresponds to the one-sided 5% significance level test against this margin.|Mean Difference (Final Values)|2.9|||<|0.05|ONE_SIDED|95.0|-0.01||||Regression, Linear|||The difference in week 24 means between groups was estimated using a linear regression model adjusted for baseline FACT-L score.|||-.01|<0.05
71661295|NCT03275064|142836252|SUPERIORITY||Mean Difference (Net)|2.09|||||TWO_SIDED|90.0|-3.49|7.66|||Mixed Models Analysis|||Week 29||7.66|-3.49|
71661296|NCT03275064|142836252|SUPERIORITY||Mean Difference (Net)|0.82|||||TWO_SIDED|90.0|-4.82|6.45|||Mixed Models Analysis|||Week 29||6.45|-4.82|
71832458|NCT03337399|143169040|NON_INFERIORITY|Pre-specified margin of -10%.|Estimated Proportions|-2.6|||<|0.15|ONE_SIDED|95.0|-10.4|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Non-inferiority of stepped PC in the proportion reporting patient-clinician communication about end-of-life care at each patient's final follow-up assessment was evaluated using a binomial generalized linear model with identity link and a one-sided test against the pre-specified margin of -10%.|||-10.4|<0.15
71832459|NCT03337399|143169041|NON_INFERIORITY|Pre-specified margin of -7 days|Median Difference (Final Values)|-15.2||||0.15|ONE_SIDED|95.0|-25.1|||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15.|Regression, Linear|||Among patients who died, non-inferiority of stepped PC in the mean length of stay in hospice was assessed using linear regression and a one-sided test against the pre-specified margin of -7 days, based upon published quality metrics.|||-25.1|0.15
71832460|NCT03337399|143169042|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.15|TWO_SIDED|95.0|-2.7|-1.8||We used a false discovery rate (FDR) control approach to interpret the results of significance tests of the three secondary outcomes with an FDR of 0.15|Regression, Linear|||The difference between groups in the mean number of outpatient PC visits per patient by week 24 was assessed using linear regression and a two-sided superiority test.||-1.8|-2.7|0.15
71889558|NCT02149810|143300714|SUPERIORITY||Mean Difference (Net)|0.109||||0.28|TWO_SIDED|95.0|-0.09|0.31||The a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on SDNN.||The primary focus of this study was the interaction effect of treatment on heart rate variability at Weeks 0 and 12. On the assumption that this effect size is medium (Cohen's f = .25), calculations (using G\*Power) 23 indicate that a sample size of 80 yield power estimates of .99 for both the interaction and the main effect of time. The study enrolled 95 participants to account for participant attrition.||0.31|-0.09|0.28
71889559|NCT02149810|143300715|SUPERIORITY||Mean Difference (Net)|0.034||||0.89|TWO_SIDED|95.0|-0.44|0.51||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|Linear mixed models, controlling for baseline score, were used to compare the SSM and TAU groups' change score from baseline to 12-week on LF HRV.||||0.51|-0.44|0.89
71889560|NCT02149810|143300716|SUPERIORITY||Mean Difference (Net)|-2.66||||0.03|TWO_SIDED|95.0|-5.05|-0.26||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.26|-5.05|0.030
71889561|NCT02149810|143300717|SUPERIORITY||Mean Difference (Net)|-2.37||||0.021|TWO_SIDED|95.0|-4.37|-0.36||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.36|-4.37|0.021
71889562|NCT02149810|143300718|SUPERIORITY||Mean Difference (Net)|11.0||||0.22|TWO_SIDED|95.0|-7.01|29.01||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||29.01|-7.01|0.22
71889563|NCT02149810|143300719|SUPERIORITY||Mean Difference (Net)|1.91||||0.72|TWO_SIDED|95.0|-8.54|12.37||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||12.37|-8.54|0.72
71889564|NCT02149810|143300720|SUPERIORITY||Mean Difference (Net)|-0.8||||0.018|TWO_SIDED|95.0|-1.46|-0.15||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||-0.15|-1.46|0.018
71889565|NCT02149810|143300721|SUPERIORITY||Mean Difference (Net)|-0.14||||0.99|TWO_SIDED|95.0|-21.94|21.66||The a priori threshold for statistical significance was set at p = 0.05.|Mixed Models Analysis|||||21.66|-21.94|0.99
71889566|NCT02149810|143300722|SUPERIORITY||Odds Ratio (OR)|3.26||||0.049|TWO_SIDED|95.0|1.01|10.53||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of participants who responded to the intervention (≥50% decrease from baseline on the HRSD, defined a priori) at the end of intervention (week 12).||10.53|1.01|0.049
71889567|NCT02149810|143300723|SUPERIORITY||Odds Ratio (OR)|3.36||||0.04|TWO_SIDED|95.0|1.06|10.64||The a priori threshold for statistical significance was set at p = 0.05.|Regression, Linear|||Generalised linear models were used to compare the proportion of the proportion of participants who achieved remission (scores ≤7 on the HRSD, defined a priori) at the end of intervention (week 12).||10.64|1.06|0.040
71889568|NCT01015833|143300734|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.24|TWO_SIDED|95.0|0.8|1.4|||t-test, 1 sided|||||1.4|0.8|0.24
71889569|NCT01015833|143300736|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.98|TWO_SIDED|95.0|0.72|1.2|||t-test, 1 sided|||||1.2|0.72|0.98
71889570|NCT02730260|143300750|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.||||0.41
71735014|NCT04018313|142985462|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|113.14|||||TWO_SIDED|90.0|103.15|124.11||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||124.11|103.15|
71735015|NCT04018313|142985462|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|103.88|||||TWO_SIDED|90.0|94.83|113.8||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||113.80|94.83|
71735016|NCT04018313|142985462|EQUIVALENCE|The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax.|Ratio of geometric least square means|91.82|||||TWO_SIDED|90.0|83.87|100.52||||||The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates.||100.52|83.87|
71773273|NCT02237911|143046313|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.074|TWO_SIDED|98.3|-5.0|0.7|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||0.7|-5.0|0.074
71660016|NCT01791153|142834319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|38.35|||||TWO_SIDED|99.5|17.89|58.81||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||58.81|17.89|
71735017|NCT03927404|142985505|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).|||||<|0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||<0.05
71773274|NCT02237911|143046313|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|98.3|-2.7|2.9|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.||2.9|-2.7|0.930
71889571|NCT02730260|143300750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.||||<0.03
71661297|NCT03275064|142836252|SUPERIORITY||Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-3.54|8.11|||Mixed Models Analysis|||Week 53||8.11|-3.54|
71773275|NCT02237911|143046313|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.491|TWO_SIDED|98.3|-3.7|2.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||2.0|-3.7|0.491
71773276|NCT02237911|143046313|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.021|TWO_SIDED|98.3|-4.5|0.1|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.1|-4.5|0.021
71889572|NCT02730260|143300750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.03|TWO_SIDED||||||Regression, Logistic|||Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.||||<0.03
71660017|NCT01791153|142834319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||||0.0002
71660018|NCT01791153|142834319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was \>/= -22.5%.|Difference in Response Rates|35.41|||||TWO_SIDED|99.5|10.41|60.41||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||60.41|10.41|
71660019|NCT01791153|142834320|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|99.0|0.11|0.46|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.46|0.11|<0.0001
71660020|NCT01791153|142834320|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39||||0.0011|TWO_SIDED|99.0|0.18|0.82|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.82|0.18|0.0011
71660021|NCT01791153|142834320|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.0001|TWO_SIDED|99.0|0.12|0.66|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||0.66|0.12|0.0001
71660022|NCT01791153|142834320|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.0316|TWO_SIDED|99.0|0.2|1.16|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (\</=30 mg/day, \>30 mg/day).||1.16|0.20|0.0316
71660023|NCT01791153|142834321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
71660024|NCT01791153|142834321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
71660025|NCT01791153|142834321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30mg/day, \>30mg/day).||||0.0003
71660026|NCT01791153|142834321|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (\<=30 mg/day, \> 30 mg/day).||||<0.0001
71660027|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|0.61||||0.8067|TWO_SIDED|99.0|-5.86|7.07|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||7.07|-5.86|0.8067
71660028|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.44||||0.0252|TWO_SIDED|99.0|-0.69|9.56|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.56|-0.69|0.0252
71660029|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-0.56||||0.8374|TWO_SIDED|99.0|-7.64|6.53|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||6.53|-7.64|0.8374
71660030|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.27||||0.1468|TWO_SIDED|99.0|-2.59|9.14|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.14|-2.59|0.1468
71735018|NCT03927404|142985507|OTHER|We used median (Inter-quartile range) to describe the continuous measures of limb health such as TEWL, Hydration, and Oxygenation levels at each visit and each location of the measurements in the sound (SL) and residual limbs (RL).||||||0.05||||||In a bivariate analysis, we used two-sided equality of the median test for the matched pairs of observations|bivariate analysis|||||||0.05
71660031|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.38||||0.057|TWO_SIDED|99.0|-1.58|10.34|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.34|-1.58|0.0570
71660032|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|5.59||||0.0024|TWO_SIDED|99.0|0.86|10.32|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||10.32|0.86|0.0024
71660033|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|3.04||||0.2218|TWO_SIDED|99.0|-3.43|9.51|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.51|-3.43|0.2218
71735019|NCT02533726|142985509|SUPERIORITY||Odds Ratio (OR)|0.27||||0.012|TWO_SIDED|95.0|0.1|0.75|||Fisher Exact|||Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).||.75|.1|.012
71735020|NCT02533726|142985509|OTHER||Odds Ratio (OR)|0.2||||0.015|TWO_SIDED|95.0|0.06|0.74|||Fisher Exact|||Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.||0.74|0.06|0.015
71735021|NCT01147848|142985512|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.037||||0.162|TWO_SIDED|95.0|-0.088|0.015|||ANCOVA||Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.|||0.015|-0.088|0.162
71832461|NCT02214550|143169062|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.69||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.02
71832462|NCT02214550|143169062|SUPERIORITY||Slope|-1.4597|STANDARD_ERROR_OF_MEAN|0.8245||0.08|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.08
71832463|NCT02214550|143169062|SUPERIORITY||Slope|1.9186|STANDARD_ERROR_OF_MEAN|0.8121||0.023|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates a time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated predicting bladder pain at first urge ratings (0-100 visual analog scale) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||.023
71832464|NCT02214550|143169063|SUPERIORITY||Slope|0.3716|STANDARD_ERROR_OF_MEAN|0.3056||0.2315|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time\*group interaction (OCP vs. No OCP). PBS participants are included in the OCP group|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.2315
71832465|NCT02214550|143169063|SUPERIORITY||Slope|0.2703|STANDARD_ERROR_OF_MEAN|0.3244||0.4097|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.4097
71832466|NCT02214550|143169063|SUPERIORITY||Slope|-0.1574|STANDARD_ERROR_OF_MEAN|0.3283||0.6341|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter estimated indicates the time x group (continuous microgestin: D+COS-vs. PBS) interaction.|A linear mixed-effects model was estimated predicting pressure pain thresholds (in Newtons of force transvaginally measured anteriorly against the bladder) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The following three orthogonal contrasts were estimated: 1) OCP vs. No OCP, 2) cyclic vs. continuous microgestin, and 3) PBS-continuous microgestin vs. D+COS-continuous microgestin.||||0.6341
71832467|NCT02214550|143169064|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.1||0.393|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (OCP vs. No OCP). PBS participants are included in the OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The OCP vs No OCP contrast was estimated here:||||.393
71832468|NCT02214550|143169064|SUPERIORITY||Slope|0.007|STANDARD_ERROR_OF_MEAN|0.09||0.941|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameters reported indicates time x group (Continuous vs. Cyclic OCP) interaction. PBS participants are included in the continuous OCP group.|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The cyclic vs. continuous microgestin contrast was run here||||0.941
71735022|NCT03596450|142985536|SUPERIORITY||Treatment effect|1.36||||0.033|TWO_SIDED|95.0|1.03|1.79|||Regression, Logistic|||Estimate and p-value are based on logistic regression model with logit link function, treatment as categorical effect, and baseline HbA1c as covariate.||1.79|1.03|0.033
71660034|NCT01791153|142834322|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|4.25||||0.0412|TWO_SIDED|99.0|-1.14|9.64|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||9.64|-1.14|0.0412
71660035|NCT01791153|142834323|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-15.6||||0.0312|TWO_SIDED|99.0|-34.3|3.1|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.1|-34.3|0.0312
71660036|NCT01791153|142834323|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-11.8||||0.0476|TWO_SIDED|99.0|-27.2|3.6|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||3.6|-27.2|0.0476
71735023|NCT02332291|142985605|SUPERIORITY||Odds Ratio, log|0.8642|STANDARD_ERROR_OF_MEAN|0.475||0.0689|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|||Statistical analyses utilized a logistic regression model with remission status (defined as final MADRS \<= 7) as the dependent variable. The independent variable of interest was treatment arm assignment, and the model included age, sex, and baseline depression severity by MADRS as covariates.||||0.0689
71773277|NCT02237911|143046313|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.179|TWO_SIDED|98.3|-3.6|1.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||1.0|-3.6|0.179
71660037|NCT01791153|142834323|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-21.9||||0.0059|TWO_SIDED|99.0|-42.4|-1.4|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-1.4|-42.4|0.0059
71773278|NCT02237911|143046314|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.0001|TWO_SIDED|98.3|0.1|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.1|<0.0001
71661298|NCT03275064|142836252|SUPERIORITY||Mean Difference (Net)|-5.96|||||TWO_SIDED|90.0|-11.81|-0.1|||Mixed Models Analysis|||Week 53||-0.10|-11.81|
71735024|NCT02332291|142985606|SUPERIORITY||Slope, fixed effect|-1.066|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|344 degrees of freedom||Statistical analyses utilized mixed model. MADRS score was the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest for this analysis was an interaction term between time and treatment assignment. A statistically significant interaction term would indicate that one treatment arm experienced a greater change in MADRS score over time than the other treatment arm.||||0.0001
71773279|NCT02237911|143046314|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.012|TWO_SIDED|98.3|0.01|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.4|0.01|0.012
71773280|NCT02237911|143046314|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.005|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.005
71773281|NCT02237911|143046314|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.052|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.052
71773282|NCT02237911|143046314|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.015|TWO_SIDED|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|0.02|0.015
71773283|NCT02237911|143046314|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.489|TWO_SIDED|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||0.3|-0.003|0.489
71773284|NCT02237911|143046315|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.943|TWO_SIDED|95.0|-106.0|114.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||114|-106|0.943
71773285|NCT02237911|143046315|SUPERIORITY||Mean Difference (Final Values)|15.0||||0.814|TWO_SIDED|95.0|-112.0|142.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||142|-112|0.814
71661299|NCT03275064|142836253|SUPERIORITY||Mean Difference (Net)|3.47|||||TWO_SIDED|90.0|-2.21|9.15|||Mixed Models Analysis|||Week 29||9.15|-2.21|
71773286|NCT02237911|143046315|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.787|TWO_SIDED|95.0|-125.0|95.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||95|-125|0.787
71773287|NCT02237911|143046315|SUPERIORITY||Mean Difference (Final Values)|-36.0||||0.581|TWO_SIDED|95.0|-164.0|92.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||92|-164|0.581
71773288|NCT02237911|143046315|SUPERIORITY||Mean Difference (Final Values)|19.0||||0.676|TWO_SIDED|95.0|-71.0|109.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||109|-71|0.676
71889573|NCT05032950|143300771|OTHER||Reference/Test Ratio|368.33|||||TWO_SIDED|90.0|318.91|425.41|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||425.41|318.91|
71889574|NCT05032950|143300772|OTHER||Reference/Test Ratio|1430.02|||||TWO_SIDED|90.0|1204.54|1697.71|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1697.71|1204.54|
71889575|NCT05032950|143300773|OTHER||Test/Reference Ratio|1451.78|||||TWO_SIDED|90.0|1224.42|1721.35|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD) (Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1721.35|1224.42|
71889576|NCT05032950|143300778|OTHER||Test/Reference Ratio|387.2|||||TWO_SIDED|90.0|335.25|447.21|||Mixed Models Analysis|||Natural log-transformed Cmax of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||447.21|335.25|
71889577|NCT05032950|143300779|OTHER||Test/Reference Ratio|1645.15|||||TWO_SIDED|90.0|1385.75|1953.11|||Mixed Models Analysis|||Natural log-transformed AUCinf of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios||1953.11|1385.75|
71889578|NCT05032950|143300780|OTHER||Test/Reference Ratio|1677.25|||||TWO_SIDED|90.0|1414.59|1988.69|||Mixed Models Analysis|||Natural log-transformed AUClast of midazolam was analyzed using mixed effect model with treatment, period and sequence as fixed effects and participant in sequence as random effect. Estimates of the adjusted mean differences (AMD)(Test-Reference) and 90%CIs were obtained from the model. The AMD and 90%CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90%CI for the ratios.||1988.69|1414.59|
71889579|NCT03136107|143300829|EQUIVALENCE|Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF||||||||||||||||CI % values (which is the percentage that half the 95 % CI represents of the mean values).|Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.|||
71889580|NCT02300129|143300837|SUPERIORITY_OR_OTHER|||||||0.742|TWO_SIDED|||||P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5% (two-sided).|ANOVA|Analysis of variance including sequence, subject (sequence), period and treatment as factors in the model||||||0.7420
71889581|NCT00522392|143300866|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Log Rank|||Stratified log rank test was used to compare progression-free survival between the two arms.||||0.092
71889582|NCT00522392|143300867|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Fisher's exact test was used to compare the response rates between the two arms.||||0.029
71889583|NCT00522392|143300868|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Log Rank|||Stratified log-rank test was used to compare overall survival between the two arms.||||0.48
71889584|NCT00432237|143300893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889585|NCT00432237|143300893|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889586|NCT00432237|143300894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889587|NCT00432237|143300894|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889588|NCT00432237|143300895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889589|NCT00432237|143300895|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889590|NCT00432237|143300896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889591|NCT00432237|143300896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889592|NCT00432237|143300897|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889593|NCT00432237|143300897|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889594|NCT00432237|143300898|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71660038|NCT01791153|142834323|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Square Means|-18.2||||0.0081|TWO_SIDED|99.0|-35.8|-0.5|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (\<=30mg/day, \>30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.||-0.5|-35.8|0.0081
71660039|NCT00975286|142834333|SUPERIORITY_OR_OTHER||[Least squares (LS) mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.463|-0.171||Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (\<8.0,\>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.171|-0.463|<0.0001
71660040|NCT01674647|142834349|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.15|1.73|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.73|0.15|
71660041|NCT01674647|142834350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.21|2.67|||no test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.26% - 1.27%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.80% (0.27% - 2.00%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.67|0.21|
71660042|NCT01674647|142834351|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.06|2.0|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.20% (0.04% - 0.71%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||2.00|0.06|
71660043|NCT01674647|142834352|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.16|1.55|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.27% - 1.29%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.22% (0.53% - 2.51%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||1.55|0.16|
71660044|NCT01674647|142834357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.18|5.47|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.41% (0.14% - 1.02%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.41% (0.07% - 1.41%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||5.47|0.18|
71660045|NCT01674647|142834358|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.2|3.49|||no statistical test performed||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals||3.49|0.20|
71773289|NCT02237911|143046315|SUPERIORITY||Mean Difference (Final Values)|51.0||||0.33|TWO_SIDED|95.0|-52.0|154.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).||||154|-52|0.330
71773290|NCT00958789|143046331|NON_INFERIORITY|"For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority.~H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta."|Mean Difference (Final Values)|70.7|||||ONE_SIDED|95.0|64.43||||||||||64.43|
71832469|NCT02214550|143169064|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05 and p-values were not adjusted for multiple comparisons given a priori orthogonal contrasts.|Mixed Models Analysis||Parameter reported indicates time x group interaction (D+COS-continuous microgestin vs. PBS-continuous microgestin).|A linear mixed-effects model was estimated for parieto-occipital peak alpha (Hz) as a function of time (0, 6, 12 month visits), group, and their interaction. Random intercepts were estimated for each participant. The PBS-continuous microgestin vs. D+COS-continuous microgestin contrast was evaluated here||||0.005
71660046|NCT01104779|142834365|SUPERIORITY||Mean Difference (Final Values)|-6.8||||0.0029|TWO_SIDED|95.0|-11.3|-2.4|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-2.4|-11.3|0.0029
71660047|NCT01104779|142834365|SUPERIORITY||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.5|-5.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-5.3|-14.5|<0.0001
71660048|NCT01104779|142834366|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0115|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo|||-0.1|-0.6|0.0115
71660049|NCT01104779|142834366|SUPERIORITY||Mean Difference (Final Values)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo|||-0.3|-0.8|<0.0001
71660050|NCT05011123|142834384|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-3.4|1.8|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||1.8|-3.4|
71773291|NCT01885871|143046342|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71832470|NCT00390299|143169093|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
71832471|NCT00390299|143169093|OTHER||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||TWO_SIDED|||||||||||||
71832472|NCT00390299|143169097|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.28|TWO_SIDED|95.0|0.67|4.11|||Log Rank|||||4.11|0.67|0.28
71832473|NCT01061671|143169133|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||negative binomial regression|Adjustments of confidence intervals for between-participant variation (overdispersion).||||||0.54
71832474|NCT01061671|143169134|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Log Rank|||||||0.34
71735025|NCT02332291|142985607|SUPERIORITY||Slope, fixed effects|-0.3117|STANDARD_ERROR_OF_MEAN|0.1566||0.0483|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|150 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, sex, and treatment assignment. The primary variable of interest was an interaction term between time and treatment assignment.||||0.0483
71735026|NCT02332291|142985608|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effect|-1.186|STANDARD_ERROR_OF_MEAN|0.181|<|0.0001|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|128 degrees of freedom||Statistical analyses utilized mixed models, with MADRS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||<0.0001
71735027|NCT02332291|142985609|OTHER|Analyses tested for effects of time in this one-arm, open-label study phase.|Slope, fixed effects|-0.2342|STANDARD_ERROR_OF_MEAN|0.0908||0.0123|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|61 degrees of freedom||Statistical analyses utilized mixed models, with QIDS score being the repeated measures dependent variable. Independent variables included time, age, and sex. The primary variable of interest was time, to indicate a change in depression severity over time with open-label treatment.||||0.0123
71773292|NCT00090051|143046364|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0218|TWO_SIDED|95.0|0.6|0.96|||Log Rank|non-stratified|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.||0.96|0.60|0.0218
71773293|NCT00090051|143046365|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Log Rank|non-stratified||||||0.2874
71773294|NCT00090051|143046367|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Log Rank|non-stratified||||||0.0002
71773295|NCT00090051|143046370|SUPERIORITY_OR_OTHER|||||||0.8842||95.0|||||Log Rank|non-stratified||||||0.8842
71773296|NCT00090051|143046372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Log Rank|||||0.80|0.54|<.0001
71773297|NCT00090051|143046373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5976|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||||1.19|0.74|0.5976
71773298|NCT00090051|143046374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.54|0.79|||Log Rank|||||0.79|0.54|<.0001
71773299|NCT00090051|143046375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.0005|TWO_SIDED|95.0|1.39|3.35|||Chi-squared|||||3.35|1.39|0.0005
71773300|NCT00090051|143046376|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3085|TWO_SIDED|95.0|0.46|1.28|||Log Rank|||||1.28|0.46|0.3085
71773301|NCT00090051|143046377|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0007|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||||0.84|0.51|0.0007
71773302|NCT00090051|143046378|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0002|TWO_SIDED|95.0|0.55|0.84|||Log Rank|||||0.84|0.55|0.0002
71735028|NCT02332291|142985610|SUPERIORITY||Slope|-0.636|STANDARD_ERROR_OF_MEAN|1.924||0.742|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear model. Final AES score at week 8 was the dependent variable. Independent variables included age, sex, baseline AES score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.742
71773303|NCT01896479|143046419|NON_INFERIORITY|The non-inferiority margin used was 1.58.|Cox Proportional Hazard|1.24||||0.1916|TWO_SIDED|95.0|0.9|1.7||Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).|Log Rank|||||1.70|0.90|0.1916
71661300|NCT03275064|142836253|SUPERIORITY||Mean Difference (Net)|-0.63|||||TWO_SIDED|90.0|-6.31|5.04|||Mixed Models Analysis|||Week 29||5.04|-6.31|
71773304|NCT01896479|143046420|OTHER|Descriptive statistical analysis.|Odds Ratio (OR)|1.0195||||0.9437|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|Stratification factors comprised RET M918T mutational status (positive, negative, and unknown).||||1.7|0.6|0.9437
71773305|NCT00433511|143046421|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|The primary objective of this trial was to determine whether the addition of bevacizumab improved IDFS. A two-step hierarchical approach was used. In the 1st step, Arm C was to be compared to Arm A. If Arm C significantly improved IDFS relative to Arm A, then in the 2nd step, a comparison of Arm B to Arm A was to be performed. If the treatment in both Arm C and Arm B significantly improved IDFS relative to Arm A, then a comparison of Arm C to Arm B was to be performed with respect to IDFS.||1.06|0.71|0.17
71773306|NCT00433511|143046422|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.41|TWO_SIDED|95.0|0.68|1.17||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|||1.17|0.68|0.41
71773307|NCT00433511|143046422|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.77|1.33||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm B/Arm A|||1.33|0.77|0.92
71773308|NCT00433511|143046422|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.36|TWO_SIDED|95.0|0.72|1.13||Two-sided; based on stratified test using stratification factors at randomization|Regression, Cox||Hazard ratio: Arm C/Arm B|||1.13|0.72|0.36
71773309|NCT03139604|143046424|OTHER||Odds Ratio (OR)|1.45||||0.0782|TWO_SIDED|95.0|0.959|2.204||Not adjusted for multiplicity with interim and final analyses|Cochran-Mantel-Haenszel|||binomial distribution||2.204|0.959|0.0782
71773310|NCT05007717|143046459|SUPERIORITY||Risk Ratio (RR)|1.04||||0.631|TWO_SIDED|95.0|0.89|1.2|||Mixed Models Analysis|Adjusted for ever missing a visit during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.20|0.89|0.631
71773311|NCT05007717|143046460|SUPERIORITY||Risk Ratio (RR)|0.79||||0.237|TWO_SIDED|95.0|0.54|1.16|||Mixed Models Analysis|Adjusted for ever being virally unsuppressed during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.16|0.54|0.237
71773312|NCT05007717|143046461|SUPERIORITY||Risk Ratio (RR)|0.98||||0.386|TWO_SIDED|95.0|0.94|1.02|||Mixed Models Analysis|Adjusted for always having \>80% coverage during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.02|0.94|0.386
71735029|NCT02332291|142985611|SUPERIORITY||Slope|-5.4705|STANDARD_ERROR_OF_MEAN|2.352||0.0232|TWO_SIDED|||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was p \< 0.05.|Regression, Linear|||Statistical analyses used a linear regression model. Final RRS score at week 8 was the dependent variable. Independent variables included age, sex, baseline RRS score, baseline MADRS score, and treatment assignment. Treatment assignment was the independent variable of interest.||||0.0232
71735030|NCT03624127|142985613|SUPERIORITY||Odds Ratio (OR)|18.71|||<|0.0001|TWO_SIDED|95.0|9.51|36.81|||Cochran-Mantel-Haenszel|||||36.81|9.51|<0.0001
71735031|NCT03624127|142985614|SUPERIORITY||Odds Ratio (OR)|11.09|||<|0.0001|TWO_SIDED|95.0|6.49|18.95|||Cochran-Mantel-Haenszel|||||18.95|6.49|<0.0001
71735032|NCT03624127|142985615|SUPERIORITY||Odds Ratio (OR)|16.15|||<|0.0001|TWO_SIDED|95.0|6.91|37.72|||Cochran-Mantel-Haenszel|||||37.72|6.91|<0.0001
71735033|NCT03624127|142985615|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0002|TWO_SIDED|95.0|1.51|3.6|||Cochran-Mantel-Haenszel|||||3.60|1.51|0.0002
71735034|NCT03624127|142985616|SUPERIORITY||Odds Ratio (OR)|31.3|||<|0.0001|TWO_SIDED|95.0|4.09|239.36|||Cochran-Mantel-Haenszel|||||239.36|4.09|<0.0001
71735035|NCT03624127|142985617|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|2.07|9.84|||Cochran-Mantel-Haenszel|||||9.84|2.07|<0.0001
71735036|NCT03624127|142985617|SUPERIORITY||Odds Ratio (OR)|39.54|||<|0.0001|TWO_SIDED|95.0|5.29|295.75|||Cochran-Mantel-Haenszel|||||295.75|5.29|<0.0001
71735037|NCT03624127|142985618|SUPERIORITY||Adjusted Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|-12.8|-4.9|||ANCOVA|||||-4.9|-12.8|<0.0001
71735038|NCT03624127|142985619|SUPERIORITY||Odds Ratio (OR)|13.67||||0.0013|TWO_SIDED|95.0|1.77|105.5|||Cochran-Mantel-Haenszel|||||105.50|1.77|0.0013
71735039|NCT03624127|142985619|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1702|TWO_SIDED|95.0|0.76|4.42|||Cochran-Mantel-Haenszel|||||4.42|0.76|0.1702
71735040|NCT03624127|142985620|SUPERIORITY||Odds Ratio (OR)|6.04|||<|0.0001|TWO_SIDED|95.0|3.46|10.53|||Cochran-Mantel-Haenszel|||||10.53|3.46|<0.0001
71832475|NCT01061671|143169135|SUPERIORITY_OR_OTHER|||||||0.1461|TWO_SIDED||||||t-test, 2 sided|||||||.1461
71735041|NCT03624127|142985621|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1049|TWO_SIDED|95.0|0.73|10.96|||Cochran-Mantel-Haenszel|||||10.96|0.73|0.1049
71735042|NCT03624127|142985622|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.78|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.78|<0.0001
71735043|NCT03624127|142985623|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.7|3.78|||Cochran-Mantel-Haenszel|||||3.78|1.70|<0.0001
71735044|NCT03624127|142985624|SUPERIORITY||Odds Ratio (OR)|11.92|||<|0.0001|TWO_SIDED|95.0|6.69|21.25|||Cochran-Mantel-Haenszel|||||21.25|6.69|<0.0001
71832476|NCT01551355|143169140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED|95.0|1.64|6.16|||t-test, 2 sided|The intervention was evaluated using generalized estimating equation models, controlling for cluster effect, sex, age, weight, and education level.||||6.16|1.64|<.001
71661301|NCT03275064|142836253|SUPERIORITY||Mean Difference (Net)|-2.63|||||TWO_SIDED|90.0|-8.07|2.82|||Mixed Models Analysis|||Week 53||2.82|-8.07|
71735045|NCT03624127|142985624|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.04|||Cochran-Mantel-Haenszel|||||6.04|2.21|<0.0001
71735046|NCT03624127|142985625|SUPERIORITY||Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|95.0|2.16|4.83|||Cochran-Mantel-Haenszel|||||4.83|2.16|<0.0001
71735047|NCT03624127|142985626|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.53|5.6|||Cochran-Mantel-Haenszel|||||5.60|2.53|<0.0001
71735048|NCT03624127|142985627|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.71|4.05|||Cochran-Mantel-Haenszel|||||4.05|1.71|<0.0001
71735049|NCT03624127|142985628|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.96|4.69|||Cochran-Mantel-Haenszel|||||4.69|1.96|<0.0001
71735050|NCT03624127|142985629|SUPERIORITY||Odds Ratio (OR)|3.11|||<|0.0001|TWO_SIDED|95.0|2.06|4.69|||Cochran-Mantel-Haenszel|||||4.69|2.06|<0.0001
71735051|NCT03624127|142985630|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0002|TWO_SIDED|95.0|1.55|4.19|||Cochran-Mantel-Haenszel|||||4.19|1.55|0.0002
71735052|NCT02262754|142985651|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|0.16|||||TWO_SIDED|90.0|-0.28|0.6||||||An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.||0.60|-0.28|
71735053|NCT02262754|142985651|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.42|||||TWO_SIDED|90.0|-0.02|0.87||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.87|-0.02|
71735054|NCT02262754|142985651|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-0.26|||||TWO_SIDED|90.0|-0.7|0.18||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.||0.18|-0.70|
71735055|NCT02262754|142985657|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.23|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.76|0.3||||||The ANCOVA model included treatment as fixed effects.||0.30|-0.76|
71735056|NCT02262754|142985657|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.41|0.65||||||The ANCOVA model included treatment as fixed effects.||0.65|-0.41|
71735057|NCT02262754|142985657|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.35|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|-0.87|0.17||||||The ANCOVA model included treatment as fixed effects.||0.17|-0.87|
71832477|NCT01551355|143169141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001|TWO_SIDED|95.0|2.03|6.12|||t-test, 2 sided|||||6.12|2.03|<.001
71832478|NCT01551355|143169142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36|||=|0.06|TWO_SIDED|95.0|-0.29|11.01|||t-test, 2 sided|||||11.01|-0.29|=.06
71889595|NCT00432237|143300898|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71735058|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.08|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.2|0.36||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.36|-0.20|
71735059|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.2|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.48|0.07||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.07|-0.48|
71735060|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.28|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.01|0.56||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.56|0.01|
71735061|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.43|0.34||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.34|-0.43|
71735062|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.24|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.62|0.15||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.15|-0.62|
71735063|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.19|0.58||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.58|-0.19|
71735064|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.39|0.45||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.45|-0.39|
71735065|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.27|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.69|0.16||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.16|-0.69|
71735066|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.3|STANDARD_ERROR_OF_MEAN|0.25||||90.0|-0.12|0.71||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.71|-0.12|
71735067|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.07|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.55||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.55|-0.40|
71735068|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.84|0.11||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.11|-0.84|
71735069|NCT02262754|142985658|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.91|-0.03|
71735070|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.03|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.03|0.08||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.08|-0.03|
71735071|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|-0.09|0.02||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.02|-0.09|
71735072|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|90.0|0.01|0.12||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|0.01|
71735073|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.09|0.1||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.10|-0.09|
71773313|NCT05007717|143046462|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.991|TWO_SIDED|95.0|0.71|1.41|||Regression, Cox|Adjusted for always coming to clinic by yourself.||||1.41|0.71|0.991
71660051|NCT05011123|142834385|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-5%|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.0|3.0|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.0|-4.0|
71660052|NCT04221789|142834397|OTHER|differences in proportions|Risk Ratio (RR)|1.12||||0.049|TWO_SIDED|95.0|1.02|1.2||Statistical significance threshold p \<0.05|Chi-squared|||Ho no difference in treatment success between groups. The study was originally powered to detect a 15% difference between groups||1.20|1.02|0.049
71660053|NCT04221789|142834398|OTHER|comparison of proportions and relative risk with 95% CI|Risk Ratio (RR)|0.7|||<|0.043|TWO_SIDED|95.0|0.5|0.97||statistical significance if p value \<0.05|Chi-squared||intervention / control|Ho No difference between arms. 80% power to detect a 10% difference||0.97|0.50|<0.043
71660054|NCT05091307|142834399|NON_INFERIORITY|The criterion for non-inferiority (NI) was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.53|||ANOVA|||A/Victoria (H1N1): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.53|1.09|
71660055|NCT05091307|142834399|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.23|||||TWO_SIDED|95.0|1.05|1.45|||ANOVA|||A/Cambodia (H3N2): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.45|1.05|
71660056|NCT05091307|142834399|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.84|1.19|||ANOVA|||B/Victoria (B/Victoria): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.19|0.84|
71660057|NCT05091307|142834399|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.88|1.21|||ANOVA|||B/Phuket (B/Yamagata): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.21|0.88|
71660058|NCT05091307|142834400|NON_INFERIORITY|The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5.|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||ANOVA|||Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 \[control group\] minus Group 1 \[CoAd group\]) was calculated and back-transformed (by exponentiation: 2\^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd).||1.26|0.97|
71735074|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.15|0.05||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.15|
71735075|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.06|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|90.0|-0.04|0.15||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.15|-0.04|
71773314|NCT05007717|143046463|SUPERIORITY||Risk Ratio (RR)|1.21||||0.037|TWO_SIDED|95.0|1.01|1.46|||Mixed Models Analysis|Adjusted for having been given fast track visits during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.46|1.01|0.037
71773315|NCT05007717|143046464|SUPERIORITY||Risk Ratio (RR)|1.04||||0.276|TWO_SIDED|95.0|0.97|1.12|||Mixed Models Analysis|Adjusted for having been given long intervals during a 6 months pre-enrollment period and always coming to clinic by yourself.||||1.12|0.97|0.276
71660059|NCT04732221|142834413|SUPERIORITY||Treatment difference|-9.2||||0.068|TWO_SIDED|95.0|-21.3|2.9||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||2.9|-21.3|0.068
71660060|NCT04732221|142834413|SUPERIORITY||Treatment difference|-22.0|||<|0.001|TWO_SIDED|95.0|-33.7|-10.3||based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-10.3|-33.7|<0.001
71660061|NCT04732221|142834413|SUPERIORITY||Treatment difference|-19.9||||0.002|TWO_SIDED|95.0|-33.4|-6.4||A 1-sided p-value was obtained from fitting a Robust regression estimate based on a Huber-type M estimator including terms for treatment and WHO-FC (Class II and Class III/IV) at baseline|Robust Regression|Missing data at week 12 due to death were imputed using the worst observed value and other missingness were imputed using J2R method|Least Square Mean of the overall treatment difference with 95% confidence interval (CI) was reported|||-6.4|-33.4|0.002
71735076|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.12|0.12||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.12|-0.12|
71773316|NCT02840240|143046476|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Mean Difference (Final Values)|-0.19||||0.003|TWO_SIDED|95.0|-1.07|0.69|||Regression, Linear|||||0.69|-1.07|0.003
71735077|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.16|0.07||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.07|-0.16|
71735078|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.05|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|-0.07|0.16||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.16|-0.07|
71735079|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.01|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.16|0.14||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.14|-0.16|
71773317|NCT02840240|143046477|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|2.12||||0.77|TWO_SIDED|95.0|0.21|18.54|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic main campus.||18.54|0.21|0.77
71735080|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.24|0.05||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.05|-0.24|
71773318|NCT02840240|143046477|NON_INFERIORITY|Noninferiority deltas were defined a priori as 1.1 for the ratio in geometric means of opioid consumption converted to IV morphine equivalents (ie, no more than 10% difference between group's median doses) and 1 point for pain score (ie, no more than 1 point worse).|Ratio of geometric means|0.32||||0.09|TWO_SIDED|95.0|0.03|3.16|||Regression, Linear|||Comparisons of opioid consumption were conducted independently for each study site. This analysis is for patients at the Cleveland Clinic Fairview hospital.||3.16|0.03|0.09
71773319|NCT02840240|143046478|SUPERIORITY||Odds Ratio (OR)|3.5||||0.11|TWO_SIDED|98.75|0.5|24.3|||Regression, Logistic|||||24.3|0.5|0.11
71773320|NCT02840240|143046479|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|98.75|0.2|3.1|||Regression, Logistic|||||3.1|0.2|0.60
71773321|NCT02007512|143046488|OTHER||Hazard Ratio (HR)|0.82||||0.3631|TWO_SIDED|95.0|0.535|1.257|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.257|0.535|0.3631
71660062|NCT02752906|142834472|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non- inferiority assumption was rejected.|Percentage Difference|5.0|||||TWO_SIDED|95.0|0.735|9.38||||||Serogroup A||9.38|0.735|
71773322|NCT02007512|143046488|OTHER||Hazard Ratio (HR)|1.022||||0.9212|TWO_SIDED|95.0|0.659|1.586|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.586|0.659|0.9212
71735081|NCT02262754|142985659|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|90.0|-0.05|0.23||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week\*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.||0.23|-0.05|
71889596|NCT00432237|143300899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71660063|NCT02752906|142834472|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|5.4|||||TWO_SIDED|95.0|2.16|8.76||||||Serogroup C||8.76|2.16|
71661302|NCT03275064|142836253|SUPERIORITY||Mean Difference (Net)|-8.16|||||TWO_SIDED|90.0|-13.61|-2.72|||Mixed Models Analysis|||Week 53||-2.72|-13.61|
71735082|NCT02262754|142985660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|90.0|0.54|1.73||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.73|0.54|
71889597|NCT00432237|143300899|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889598|NCT00432237|143300900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889599|NCT00432237|143300900|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).||||||<0.001
71889600|NCT00603239|143300901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made (alpha = 0.05).|ANCOVA|No adjustments for multiplicity were made.||Null hypothesis = Change from baseline in HbA1c is equal between the two treatment groups. Greater than 99% power to detect a difference between treatment groups of 0.88% in change in HbA1c from baseline using a 2-sided t-test at a significance level of 0.05.||||<0.001
71889601|NCT00603239|143300902|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects with HbA1c \<= 7% is equal between the two treatment groups.||||0.113
71889602|NCT00603239|143300903|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects achieving HbA1c \<= 6.5% is equal between the two treatment groups.||||0.004
71889603|NCT00603239|143300904|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.||||0.009
71889604|NCT00603239|143300905|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.||||0.176
71889605|NCT00603239|143300907|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.||||0.009
71889606|NCT00603239|143300908|SUPERIORITY_OR_OTHER|||||||0.794||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.||||0.794
71889607|NCT00603239|143300909|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments (alpha = 0.05).|Fisher Exact|No adjustment for multiplicity.||Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.||||1.00
71889608|NCT00603239|143300910|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.||||0.342
71889609|NCT00603239|143300911|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||No adjustments (alpha = 0.05)|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.||||0.186
71889610|NCT01354132|143300912|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
71889611|NCT01354132|143300913|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
71889612|NCT01354132|143300914|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71889613|NCT01354132|143300915|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71889614|NCT01354132|143300916|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||Speed of Processing||||0.022
71889615|NCT01354132|143300917|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||||||0.270
71889616|NCT01354132|143300918|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
71889617|NCT01354132|143300919|SUPERIORITY|||||||0.876|||||||t-test, 2 sided|||||||0.876
71889618|NCT01354132|143300920|SUPERIORITY|||||||0.464|||||||t-test, 2 sided|||||||0.464
71889619|NCT01354132|143300921|SUPERIORITY|||||||0.741|||||||t-test, 2 sided|||||||0.741
71889620|NCT01354132|143300922|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71889621|NCT01354132|143300923|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71889622|NCT01354132|143300924|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
71889623|NCT01354132|143300925|SUPERIORITY|||||||0.6732|||||||t-test, 1 sided|||||||0.6732
71889624|NCT01354132|143300926|SUPERIORITY|||||||0.8786|||||||t-test, 2 sided|||||||0.8786
71889625|NCT01354132|143300927|SUPERIORITY|||||||0.5622|||||||t-test, 2 sided|||||||0.5622
71889626|NCT01354132|143300928|SUPERIORITY|||||||0.9574|||||||t-test, 2 sided|||||||0.9574
71889627|NCT01354132|143300929|SUPERIORITY|||||||0.0043|||||||t-test, 2 sided|||||||0.0043
71889628|NCT01354132|143300930|SUPERIORITY|||||||0.3804|||||||t-test, 2 sided|||||||0.3804
71889629|NCT01354132|143300931|SUPERIORITY|||||||0.9403|||||||t-test, 2 sided|||||||0.9403
71889630|NCT01354132|143300932|SUPERIORITY|||||||0.9215|||||||t-test, 2 sided|||||||0.9215
71889631|NCT02357420|143300933|SUPERIORITY|||||||0.36|||||||Measures mixed effects model (MMRM)|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.36
71660064|NCT02752906|142834472|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.907|4.55||||||Serogroup Y||4.55|-0.907|
71660065|NCT02752906|142834472|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was \> -10%, the non-inferiority assumption was rejected.|Percentage Difference|7.4|||||TWO_SIDED|95.0|4.3|10.9||||||Serogroup W||10.9|4.30|
71735083|NCT02262754|142985660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|90.0|0.81|2.51||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.51|0.81|
71773323|NCT02007512|143046489|OTHER||Hazard Ratio (HR)|0.442||||0.0335|TWO_SIDED|95.0|0.205|0.955|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.955|0.205|0.0335
71773324|NCT02007512|143046489|OTHER||Hazard Ratio (HR)|0.554||||0.1936|TWO_SIDED|95.0|0.225|1.363|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.363|0.225|0.1936
71773325|NCT02007512|143046506|OTHER||Hazard Ratio (HR)|0.928||||0.7378|TWO_SIDED|95.0|0.599|1.438|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.438|0.599|0.7378
71889632|NCT02357420|143300933|SUPERIORITY|||||||0.25|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.25
71661303|NCT04159935|142836265|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71661304|NCT04159935|142836266|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||||||0.057
71661305|NCT04159935|142836267|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71661306|NCT04159935|142836269|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71661307|NCT04159935|142836270|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71735084|NCT02262754|142985660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68|||||TWO_SIDED|90.0|0.39|1.2||||||\>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.20|0.39|
71661308|NCT04159935|142836271|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
71661309|NCT04159935|142836272|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71735085|NCT02262754|142985660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|90.0|0.37|1.81||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.81|0.37|
71735086|NCT02262754|142985660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|90.0|0.53|2.35||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||2.35|0.53|
71735087|NCT02262754|142985660|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|90.0|0.33|1.6||||||\>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.||1.60|0.33|
71735088|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.18|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.06|0.7||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.70|-1.06|
71735089|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.91|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-1.8|-0.03||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.03|-1.80|
71735090|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.73|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.15|1.61||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.61|-0.15|
71735091|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.7|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.69|0.29||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.29|-1.69|
71735092|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.11|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.11|-2.11|
71735093|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.41|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.57|1.39||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.39|-0.57|
71773326|NCT02007512|143046506|OTHER||Hazard Ratio (HR)|0.968||||0.8817|TWO_SIDED|95.0|0.632|1.483|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.483|0.632|0.8817
71773327|NCT02007512|143046507|OTHER||Hazard Ratio (HR)|0.522||||0.127|TWO_SIDED|95.0|0.224|1.217|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||1.217|0.224|0.1270
71773328|NCT02007512|143046507|OTHER||Hazard Ratio (HR)|0.37||||0.0359|TWO_SIDED|95.0|0.143|0.961|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.||0.961|0.143|0.0359
71889633|NCT02357420|143300933|SUPERIORITY|||||||0.59|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.||||||0.59
71661310|NCT04159935|142836273|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.400
71661311|NCT04159935|142836275|OTHER|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||||||0.343
71660066|NCT02906930|142834482|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.3|<0.0001
71660067|NCT02906930|142834482|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.1|<0.0001
71660068|NCT02906930|142834482|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.8|<0.0001
71660069|NCT02906930|142834482|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 3 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.9|<0.0001
71661312|NCT04159935|142836276|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.700
71735094|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.41|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-1.42|0.6||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||0.60|-1.42|
71735095|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.27|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-2.28|-0.27||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||-0.27|-2.28|
71735096|NCT02262754|142985666|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.86|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-0.12|1.85||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.||1.85|-0.12|
71773329|NCT01466595|143046525|SUPERIORITY_OR_OTHER|||||||0.028||||||not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|no other adjustments||"Null hypothesis:~There is no difference between the two arms in the change in T-cell activation from baseline to week 4"||||0.028
71735097|NCT02262754|142985667|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Placebo)|-0.64|||||TWO_SIDED|90.0|-1.63|0.35||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||0.35|-1.63|
71735098|NCT02262754|142985667|SUPERIORITY_OR_OTHER||Mean Difference (Naproxen-Placebo)|-1.43|||||TWO_SIDED|90.0|-2.4|-0.45||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||-0.45|-2.40|
71832479|NCT01827787|143169144|SUPERIORITY|||||||0.42|||||||Fisher Exact|||"Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.~Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done."||||0.42
71661313|NCT04159935|142836277|OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
71832480|NCT03482635|143169153|OTHER||Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.105|0.202|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.202|-0.105|
71832481|NCT03482635|143169153|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
71735099|NCT02262754|142985667|SUPERIORITY_OR_OTHER||Mean Difference (PF-06372865-Naproxen)|0.79|||||TWO_SIDED|90.0|-0.22|1.8||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19\^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.||1.80|-0.22|
71735100|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-1.52|0.78||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.78|-1.52|
71773330|NCT02117414|143046575|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|95.0|97.75|||A priori threshold for statistical significance was 0.025.|one-proportion binomial exact test|||The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.|||97.75|<0.0001
71773331|NCT02117414|143046576|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.2|||<|0.0001|ONE_SIDED|95.0|-3.8|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-3.8|<0.0001
71773332|NCT02117414|143046577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 8%.|Difference in percentages|0.6||||0.0001|ONE_SIDED|95.0|-4.1|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group - 8% HA: % successes MRI group \> % successes Control group - 8%"|||-4.1|0.0001
71832482|NCT03482635|143169153|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
71832483|NCT03482635|143169154|OTHER||Risk Difference (RD)|-0.051|||||TWO_SIDED|95.0|-0.276|0.176|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.176|-0.276|
71661314|NCT00724048|142836288|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.078|TWO_SIDED|95.0|-2.47|0.13|||ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.13|-2.47|0.078
71735101|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.95|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|-2.1|0.2||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.20|-2.10|
71735102|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.58|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-0.56|1.71||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.71|-0.56|
71735103|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-1.02|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.06|0.02||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-2.06|
71735104|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-1.21|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|90.0|-2.25|-0.17||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.17|-2.25|
71735105|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.19|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|90.0|-0.82|1.19||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||1.19|-0.82|
71735106|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-1.39|-0.15||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.15|-1.39|
71735107|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-0.8|0.45||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.45|-0.80|
71735108|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.6|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-1.21|0.02||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.02|-1.21|
71735109|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.85|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.42|-0.28||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.28|-1.42|
71735110|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.67|0.46||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||0.46|-0.67|
71773333|NCT02117414|143046578|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis will be rejected if the one-sided 95% log-log transformed lower confidence bound at 120 days post-implant calculated using Kaplan-Meier (K-M) method is greater than 80%.|Complication-free rate|95.9|||<|0.0001|ONE_SIDED|95.0|93.0|||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||"The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p \> 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit)."|||93.0|<0.0001
71773334|NCT02117414|143046579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|1.2|||<|1e-05|ONE_SIDED|90.0|-3.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|||-3.1|<0.00001
71773335|NCT02117414|143046580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%|Difference in percentages|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.05. Because the success rate was 100% in each group, a p-value could not be calculated.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."||||
71773336|NCT02117414|143046581|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|-1.3||||0.006|ONE_SIDED|90.0|-7.0||||Farrington-Manning non-inferiority test|||"The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-7.0|0.006
71773337|NCT02117414|143046582|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 10%.|Difference in percentages|0.3||||0.005|ONE_SIDED|90.0|-6.2|||A priori threshold for statistical significance was 0.05|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group - 10% HA: % successes MRI group \> % successes Control group - 10%"|||-6.2|0.005
71773338|NCT02169284|143046604|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in benign tissue between erlotinib and placebo||||0.208
71773339|NCT02169284|143046604|OTHER|||||||0.208|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in benign tissue between erlotinib and placebo||||0.208
71773340|NCT02169284|143046604|OTHER|||||||0.272|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in benign tissue between erlotinib and placebo||||0.272
71773341|NCT02169284|143046604|OTHER|||||||0.22|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in benign tissue between erlotinib and placebo||||0.220
71889634|NCT00928070|143300938|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.21||0.0018|TWO_SIDED|95.0|-1.05|-0.24||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.24|-1.05|0.0018
71661315|NCT00724048|142836288|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.084|TWO_SIDED|95.0|-2.53|0.16||Hypothesis testing was completed only if ACR16 45 mg BID (90 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||0.16|-2.53|0.084
71773342|NCT02169284|143046605|OTHER|||||||0.361|||||||Wilcoxon rank-sum test|||Nucleus P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.361
71773343|NCT02169284|143046605|OTHER|||||||0.383|||||||Wilcoxon rank-sum test|||Cytoplasm P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.383
71773344|NCT02169284|143046605|OTHER|||||||0.427|||||||Wilcoxon rank-sum test|||Membrane P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.427
71773345|NCT02169284|143046605|OTHER|||||||0.416|||||||Wilcoxon rank-sum test|||Entire Cell P-EGFR in Tumor Tissue, p-value between placebo and Erlotinib||||0.416
71773346|NCT02169284|143046606|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
71773347|NCT02169284|143046606|OTHER|||||||0.199|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.199
71773348|NCT02169284|143046606|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
71735111|NCT02262754|142985668|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|-0.74|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-1.29|-0.2||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.||-0.20|-1.29|
71735112|NCT02262754|142985669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|90.0|0.61|1.58||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||1.58|0.61|
71735113|NCT02262754|142985669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|90.0|1.33|3.14||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||3.14|1.33|
71735114|NCT02262754|142985669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||||TWO_SIDED|90.0|0.31|0.74||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.||0.74|0.31|
71735115|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.01|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.19|0.2||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.20|-0.19|
71735116|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.34|0.05||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.34|
71773349|NCT02169284|143046607|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Baseline visit - p-value between erlotinib and placebo arms||||1.000
71773350|NCT02169284|143046607|OTHER|||||||0.288|||||||Wilcoxon rank-sum test|||Day 8 - p-value between erlotinib and placebo arms||||0.288
71661316|NCT00724048|142836288|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.982|TWO_SIDED|95.0|-1.35|1.32||Hypothesis testing was completed only if ACR16 22.5 mg BID (45 mg) vs. placebo was significant.|ANCOVA|||The ANCOVA model included a term for treatment, as well as covariates for baseline mMS, and age at entry to the study.||1.32|-1.35|0.982
71735117|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.15|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-0.05|0.35||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.35|-0.05|
71773351|NCT02169284|143046607|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Surgery visit - p-value between erlotinib and placebo arms||||<0.001
71773352|NCT02169284|143046608|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||P-value between groups at Baseline||||0.792
71773353|NCT02169284|143046608|OTHER|||||||0.261|||||||Wilcoxon rank-sum test|||P-value between groups at surgery visit||||0.261
71735118|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.18|-0.26|
71735119|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.15|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.37|0.07||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.07|-0.37|
71735120|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.33||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.33|-0.10|
71773354|NCT02169284|143046609|OTHER|||||||0.721|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Benign Tissue, P-Value between arms||||0.721
71773355|NCT02169284|143046609|OTHER|||||||0.108|||||||Wilcoxon rank-sum test|||Expression of e-cadherin in Tumor Tissue, P-Value between arms||||0.108
71773356|NCT02169284|143046610|OTHER|||||||0.444|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Benign Tissue, P-Value between arms||||0.444
71773357|NCT02169284|143046610|OTHER|||||||0.663|||||||Wilcoxon rank-sum test|||Expression of KI-67 in Tumor Tissue, P-Value between arms||||0.663
71773358|NCT02169284|143046611|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in p-ERK between Normal and Tumor Tissue, P-Value between arms||||1.000
71773359|NCT02169284|143046611|OTHER|||||||0.792|||||||Wilcoxon rank-sum test|||Difference in Cytoplasm p-ERK between Normal and Tumor Tissue, P-Value between arms||||0.792
71735121|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.09|0.38||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.09|
71735122|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|0.02|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.21|0.25||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.25|-0.21|
71735123|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|90.0|-0.1|0.36||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.36|-0.10|
71773360|NCT02169284|143046611|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Difference in Entire Cell p-ERK between Normal and Tumor Tissue, p-value between arms||||1.000
71889635|NCT00928070|143300939|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.27|-0.38||Statistical testing, two-sided, was done at 5% significance level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.||-0.38|-1.27|0.0003
71889636|NCT00928070|143300940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
71661317|NCT03923530|142836295|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.12
71661318|NCT03923530|142836296|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.49
71773361|NCT02169284|143046612|OTHER|||||||0.772|||||||Wilcoxon rank-sum test|||||||0.772
71773362|NCT03583073|143046614|SUPERIORITY|||||||0.053|||||||Chi-squared, Corrected|DF = 1||||||.053
71773363|NCT03583073|143046615|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.072|TWO_SIDED|95.0|-0.18|4.06|||Chi-squared, Corrected|||||4.06|-0.18|.072
71773364|NCT01367119|143046616|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.171
71773365|NCT01367119|143046617|SUPERIORITY_OR_OTHER|||||||0.258||95.0|||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.||||0.258
71773366|NCT01367119|143046618|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||Comparison between groups for nausea||||0.091
71773367|NCT01367119|143046618|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|||Comparison between groups for headache||||0.763
71773368|NCT01367119|143046618|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||t-test, 2 sided|||Comparison between groups for myalgia||||0.356
71661319|NCT03923530|142836297|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.03
71661320|NCT03923530|142836298|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.27
71661321|NCT03923530|142836299|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.18
71773369|NCT01367119|143046618|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Comparison between groups for visual disturbance||||0.093
71773370|NCT01367119|143046618|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||Comparison between groups for confusion||||0.003
71735124|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|0.12|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.13|0.38||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.38|-0.13|
71735125|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.21|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.46|0.05||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.05|-0.46|
71735126|NCT02262754|142985670|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.08|0.58||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.||0.58|0.08|
71735127|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.17|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.42|0.08||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.08|-0.42|
71735128|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.37|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.62|-0.12||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.62|
71735129|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.05|0.45||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.45|-0.05|
71735130|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.21||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.38|
71773371|NCT01367119|143046618|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||Comparison between groups for recovery room agitation||||0.860
71773372|NCT03180684|143046619|SUPERIORITY|||||||0.0071|||||||Clopper Pearson|A 1-sided p-value was calculated to prove superiority over historical control of 2%. Superiority of VGX-3100 alone was declared if p-value is \<0.025.||||||0.0071
71832484|NCT03482635|143169154|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.199|0.28|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.280|-0.199|
71735131|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.29|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.58|0.01||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.01|-0.58|
71735132|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.2|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.09|0.49||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.49|-0.09|
71735133|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.07|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.36|0.21||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.36|
71735134|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.38|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.67|-0.1||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.10|-0.67|
71773373|NCT03180684|143046619|SUPERIORITY|||||||0.0004|||||||Clopper Pearson|1-sided p-value was calculated to prove superiority over historical control of 2%.Superiority of VGX-3100+imiquimod was declared if p-value is \<0.025.||||||0.0004
71773374|NCT00586196|143046641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.3|||GEE|||||2.3|0.4|
71661322|NCT03923530|142836300|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.8
71735135|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.31|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.03|0.59||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.59|0.03|
71773375|NCT00586196|143046642|SUPERIORITY_OR_OTHER||Effect Size|-0.2|||||TWO_SIDED|95.0|-1.5|1.2|||GEE|||||1.2|-1.5|
71773376|NCT01484054|143046648|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-3.2|5.2|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.||5.20|-3.20|
71832485|NCT03482635|143169154|OTHER||Risk Difference (RD)|0.033|||||TWO_SIDED|95.0|-0.204|0.252|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.252|-0.204|
71832486|NCT03482635|143169155|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.258|-0.072|
71735136|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (PF-06372865-Placebo)|-0.11|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.42|0.21||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.21|-0.42|
71735137|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference (Naproxen-Placebo)|-0.43|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.75|-0.12||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||-0.12|-0.75|
71735138|NCT02262754|142985671|SUPERIORITY_OR_OTHER||LS Mean Difference(PF-06372865-Naproxen)|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.02|0.63||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week \* treatment interaction, and the baseline \* week interaction as fixed effects and week repeated within each participant as a repeated effect.||0.63|0.02|
71735139|NCT02262754|142985672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|||||TWO_SIDED|90.0|0.46|1.56||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||1.56|0.46|
71735140|NCT02262754|142985672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||||TWO_SIDED|90.0|0.23|0.81||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||0.81|0.23|
71735141|NCT02262754|142985672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|90.0|1.06|3.65||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.||3.65|1.06|
71735142|NCT02577016|142985675|SUPERIORITY||Difference in least squares means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.05|-0.62|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.62|-1.05|<0.001
71735143|NCT02577016|142985678|SUPERIORITY||Difference in least squares means|-42.5|||<|0.001|TWO_SIDED|95.0|-53.7|-31.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-31.2|-53.7|<0.001
71735144|NCT02577016|142985679|SUPERIORITY||Difference in least squares means|-67.0|||<|0.001|TWO_SIDED|95.0|-84.0|-50.0|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-50.0|-84.0|<0.001
71735145|NCT02577016|142985680|SUPERIORITY||Difference in least squares means|-11.2|||<|0.001|TWO_SIDED|95.0|-17.2|-5.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-5.2|-17.2|<0.001
71735146|NCT02126839|142985681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.02|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|16.1|33.94|||mixed model repeated measures analysis|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||33.94|16.10|<0.0001
71735147|NCT02126839|142985682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.33|STANDARD_ERROR_OF_MEAN|14.47|<|0.0001|TWO_SIDED|95.0|47.76|104.91|||mixed model repeated measures|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.||||104.91|47.76|<0.0001
71735148|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||1|TWO_SIDED|95.0|0.083|0.359|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.359|0.083|1.000
71832487|NCT03482635|143169155|OTHER||Risk Difference (RD)|0.087|||||TWO_SIDED|95.0|-0.069|0.268|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.268|-0.069|
71661323|NCT03923530|142836301|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Change from baseline to 8 weeks||||0.76
71735149|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.23||||0.9999|TWO_SIDED|95.0|0.111|0.492|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.492|0.111|0.9999
71735150|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9997|TWO_SIDED|95.0|0.121|0.568|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.568|0.121|0.9997
71735151|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9997|TWO_SIDED|95.0|0.136|0.66|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.660|0.136|0.9997
71735152|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.133|0.632|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.632|0.133|0.9991
71735153|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.46||||0.9631|TWO_SIDED|95.0|0.213|1.081|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.081|0.213|0.9631
71735154|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9941||95.0|0.157|0.789|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.789|0.157|0.9941
71735155|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9875|TWO_SIDED|95.0|0.179|0.891|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.891|0.179|0.9875
71735156|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.33||||0.9956|TWO_SIDED|95.0|0.151|0.759|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.759|0.151|0.9956
71735157|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9964|TWO_SIDED|95.0|0.157|0.747|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.747|0.157|0.9964
71735158|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9999|TWO_SIDED|95.0|0.114|0.532|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.532|0.114|0.9999
71735159|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.647|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.647|0.130|0.9991
71735160|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.36||||0.9852|TWO_SIDED|0.9852|0.137|0.906|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.906|0.137|0.9852
71832488|NCT03482635|143169155|OTHER||Risk Difference (RD)|0.071|||||TWO_SIDED|95.0|-0.081|0.226|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\]. 95% CI for risk difference were calculated using the method of Newcombe.|||0.226|-0.081|
71773377|NCT01484054|143046649|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|4.7|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-0.79|10.19|||Mixed Models Analysis|||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.||10.19|-0.79|
71773378|NCT01484054|143046650|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|9.44|STANDARD_ERROR_OF_MEAN|1.829|||TWO_SIDED|95.0|5.81|13.07|||Mixed Models Analysis|||Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.||13.07|5.81|
71773379|NCT01610271|143046651|SUPERIORITY|ABS was expected to be superior to Control.|Odds Ratio (OR)|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.067|TWO_SIDED|95.0|0.01|2.05||a priori threshold was 0.05|Regression, Logistic|penalized maximum likelihood (Firth) logistic regression, because infection rate was very low (\<3%), as expected|The dispersion is the SE of the OR. ABS was the numerator group, Control was the denominator.|A sample size of 150 per group provided a power of 80% to detect a statistically significant (α≤0.05) 3% difference in SSI rate based on a historical infection rate of 6% in the facility where operations were performed.||2.05|0.01|0.067
71773380|NCT00364130|143046655|SUPERIORITY_OR_OTHER|||||||0.38||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.38
71773381|NCT00364130|143046656|SUPERIORITY_OR_OTHER|||||||0.8||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.80
71773382|NCT00364130|143046657|SUPERIORITY_OR_OTHER|||||||0.02||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.02
71773383|NCT00364130|143046658|SUPERIORITY_OR_OTHER|||||||0.27||||||The outcome was not adjusted for multiple comparisons|Regression, Linear|||||||0.27
71773384|NCT00364130|143046659|SUPERIORITY_OR_OTHER|||||||0.84||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.84
71773385|NCT00364130|143046660|SUPERIORITY_OR_OTHER|||||||0.66||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.66
71773386|NCT00364130|143046661|SUPERIORITY_OR_OTHER|||||||0.7||||||The outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.70
71773387|NCT00364130|143046662|SUPERIORITY_OR_OTHER|||||||0.98||||||Outcome is not adjusted for multiple comparisons|Regression, Linear|||||||0.98
71773388|NCT00410202|143046663|SUPERIORITY_OR_OTHER||Difference Estimate|8.9||||0.1336|TWO_SIDED|95.0|-2.0|19.9|||Hochberg procedure|||||19.9|-2.0|0.1336
71773389|NCT00410202|143046663|SUPERIORITY_OR_OTHER||Difference Estimate|5.7||||0.2619|TWO_SIDED|95.0|-4.2|15.5|||Hochberg procedure|||||15.5|-4.2|0.2619
71773390|NCT00410202|143046664|SUPERIORITY_OR_OTHER||Difference estimate|15.0||||0.0095|TWO_SIDED|95.0|3.7|26.4|||Hochberg procedure|||||26.4|3.7|0.0095
71773391|NCT00410202|143046665|SUPERIORITY_OR_OTHER||Difference Estimate|11.8|||||TWO_SIDED|95.0|2.5|21.1||||||||21.1|2.5|
71773392|NCT00410202|143046665|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-1.1|18.2||||||||18.2|-1.1|
71773393|NCT00410202|143046666|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|1.8|23.9||||||||23.9|1.8|
71832489|NCT03482635|143169156|OTHER||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.072|0.258|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.258|-0.072|
71832490|NCT03482635|143169156|OTHER||Risk Difference (RD)|0.043|||||TWO_SIDED|95.0|-0.104|0.21|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.210|-0.104|
71832491|NCT03482635|143169156|OTHER||Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|-0.11|0.177|||||Unadjusted absolute risk difference to placebo, \[Treatment - Placebo\].|||0.177|-0.110|
71832492|NCT03482635|143169157|OTHER||Difference of adjusted means|-0.3|STANDARD_ERROR_OF_MEAN|10.7||0.9776|TWO_SIDED|95.0|-21.6|21.0|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||21.0|-21.6|0.9776
71773394|NCT00410202|143046667|SUPERIORITY_OR_OTHER||Difference Estimate|8.9|||||TWO_SIDED|95.0|0.3|17.4||||||||17.4|0.3|
71773395|NCT00410202|143046667|SUPERIORITY_OR_OTHER||Difference Estimate|8.6|||||TWO_SIDED|95.0|-0.1|17.3||||||||17.3|-0.1|
71773396|NCT00410202|143046668|SUPERIORITY_OR_OTHER||Difference estimate|12.9|||||TWO_SIDED|95.0|2.4|23.4||||||||23.4|2.4|
71773397|NCT00410202|143046671|SUPERIORITY_OR_OTHER||Difference Estimate|-1.26|||||TWO_SIDED|95.0|-1.534|-0.994|||Regression, Linear|||||-0.994|-1.534|
71773398|NCT00410202|143046671|SUPERIORITY_OR_OTHER||Difference Estimate|-0.55|||||TWO_SIDED|95.0|-0.824|-0.281|||Regression, Linear|||||-0.281|-0.824|
71773399|NCT00410202|143046673|SUPERIORITY_OR_OTHER||Difference Estimate|-2.4|||||TWO_SIDED|95.0|-15.5|10.7||||||||10.7|-15.5|
71773400|NCT00410202|143046673|SUPERIORITY_OR_OTHER||Difference Estimate|-1.2|||||TWO_SIDED|95.0|-15.0|12.6||||||||12.6|-15.0|
71773401|NCT00410202|143046674|SUPERIORITY_OR_OTHER||Difference Estimate|-2.8|||||TWO_SIDED|95.0|-16.2|10.6||||||||10.6|-16.2|
71773402|NCT00410202|143046675|SUPERIORITY_OR_OTHER||Difference Estimate|0.8|||||TWO_SIDED|95.0|-5.2|6.7||||||||6.7|-5.2|
71773403|NCT00410202|143046675|SUPERIORITY_OR_OTHER||Difference Estimate|1.3|||||TWO_SIDED|95.0|-4.6|7.2||||||||7.2|-4.6|
71773404|NCT00410202|143046676|SUPERIORITY_OR_OTHER||Difference Estimate|-1.5|||||TWO_SIDED|95.0|-9.5|6.4||||||||6.4|-9.5|
71773405|NCT00410202|143046677|SUPERIORITY_OR_OTHER||Difference Estimate|2.2|||||TWO_SIDED|95.0|-2.4|6.8||||||||6.8|-2.4|
71773406|NCT00410202|143046677|SUPERIORITY_OR_OTHER||Difference Estimate|1.4|||||TWO_SIDED|95.0|-3.5|6.2||||||||6.2|-3.5|
71773407|NCT00410202|143046678|SUPERIORITY_OR_OTHER||Difference Estimate|2.1|||||TWO_SIDED|95.0|-3.6|7.8||||||||7.8|-3.6|
71773408|NCT00410202|143046679|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
71773409|NCT00410202|143046679|SUPERIORITY_OR_OTHER||Difference Estimate|0.0|||||TWO_SIDED|95.0|-2.0|2.0||||||||2.0|-2.0|
71773410|NCT00410202|143046681|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
71773411|NCT00410202|143046681|SUPERIORITY_OR_OTHER||Difference Estimate|0.7|||||TWO_SIDED|95.0|-0.7|2.1||||||||2.1|-0.7|
71735161|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9719|TWO_SIDED|95.0|0.23|1.014|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.014|0.230|0.9719
71735162|NCT01597635|142985738|SUPERIORITY||Ratio of Active/Placebo|3.98||||1|TWO_SIDED|95.0|2.263|6.919|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||6.919|2.263|1.0000
71735163|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.46||||1|TWO_SIDED|95.0|1.976|6.052|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||6.052|1.976|1.000
71735164|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.59||||1|TWO_SIDED|95.0|2.06|6.345|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||6.345|2.060|1.0000
71735165|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.82||||0.9806|TWO_SIDED|95.0|1.031|3.17|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||3.170|1.031|0.9806
71735166|NCT01597635|142985738|SUPERIORITY||Ratio of Active/Placebo|1.5||||0.9129|TWO_SIDED|95.0|0.828|2.636|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||2.636|0.828|0.9129
71735167|NCT01597635|142985738|SUPERIORITY||Ratio of Active/Placebo|1.92||||0.9891|TWO_SIDED|95.0|1.098|3.349|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.349|1.098|0.9891
71735168|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.29||||0.9983|TWO_SIDED|95.0|1.316|3.974|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||3.974|1.316|0.9983
71735169|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.94||||0.99|TWO_SIDED|95.0|1.112|3.359|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||3.359|1.112|0.9900
71735170|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.7996|TWO_SIDED|95.0|0.729|2.163|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||2.163|0.729|0.7996
71735171|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7778|TWO_SIDED|95.0|0.718|2.087|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||2.087|0.718|0.7778
71735172|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.24||||0.773|TWO_SIDED|95.0|0.705|2.113|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.113|0.705|0.7730
71773412|NCT00144027|143046698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.57||||0.03|TWO_SIDED|95.0|1.21|47.53|||Regression, Logistic|logistic regression predicting 6-month adherence, controling for baseline depression, extrapyramidal side effects, and baseline adherence.||||47.53|1.21|0.03
71773413|NCT04824365|143046772|SUPERIORITY||Mean Difference (Final Values)|-0.3379|STANDARD_ERROR_OF_MEAN|0.1438||0.0197|TWO_SIDED|95.0|-0.6213|-0.0545|||ANOVA|two-way ANOVA||||-0.0545|-0.6213|0.0197
71889637|NCT00928070|143300940|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
71735173|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.45||||0.8951|TWO_SIDED|95.0|0.814|2.604|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.604|0.814|0.8951
71735174|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.57||||0.9324|TWO_SIDED|95.0|0.276|1.183|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||1.183|0.276|0.9324
71735175|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.63||||0.8982|TWO_SIDED|95.0|0.351|1.257|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.257|0.351|0.8982
71735176|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|4.22||||0.9998|TWO_SIDED|95.0|1.91|8.905|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||8.905|1.910|0.9998
71735177|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|3.67||||0.9993|TWO_SIDED|95.0|1.689|7.97|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||7.970|1.689|0.9993
71735178|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|5.26||||1|TWO_SIDED|95.0|2.392|11.754|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||11.754|2.392|1.0000
71773414|NCT04824365|143046773|SUPERIORITY||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.1129||0.736|TWO_SIDED|95.0|-0.1843|0.2605|||ANOVA|Two-way ANOVA||||0.2605|-0.1843|0.736
71773415|NCT04824365|143046774|SUPERIORITY||Mean Difference (Final Values)|0.3131|STANDARD_ERROR_OF_MEAN|0.1049||0.003|TWO_SIDED|95.0|0.1069|0.5193|||ANOVA|Two-way ANOVA||||0.5193|0.1069|0.0030
71735179|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.25||||0.9713|TWO_SIDED|95.0|0.972|5.136|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||5.136|0.972|0.9713
71735180|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|2.19||||0.9649|TWO_SIDED|95.0|0.94|4.975|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||4.975|0.940|0.9649
71735181|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.59||||0.8749|TWO_SIDED|95.0|0.711|3.473|||Mixed Models Analysis|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||3.473|0.711|0.8749
71735182|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.99||||0.9566|TWO_SIDED|95.0|0.899|4.342|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||4.342|0.899|0.9566
71735183|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.91||||0.9549|TWO_SIDED|95.0|0.862|4.173|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||4.173|0.862|0.9549
71735184|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.81||||0.9275|TWO_SIDED|95.0|0.816|4.005|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||4.005|0.816|0.9275
71889638|NCT00928070|143300942|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24||0.0003|TWO_SIDED|95.0|-1.35|-0.4||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.40|-1.35|0.0003
71889639|NCT00928070|143300942|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.29|-0.39||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.||-0.39|-1.29|0.0003
71735185|NCT01597635|142985738|SUPERIORITY||Ratio of Active/Placebo|1.32||||0.7483|TWO_SIDED|95.0|0.584|3.007|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||3.007|0.584|0.7483
71735186|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.648|TWO_SIDED|95.0|0.516|2.675|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||2.675|0.516|0.6480
71735187|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.76||||0.9038|TWO_SIDED|95.0|0.741|4.17|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||4.170|0.741|0.9038
71735188|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7339|TWO_SIDED|95.0|0.49|3.915|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||3.915|0.490|0.7339
71735189|NCT01597635|142985738|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.38||||0.7714|TWO_SIDED|95.0|0.651|3.321|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.321|0.651|0.7714
71735190|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.07||||1|TWO_SIDED|95.0|0.032|0.14|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.032|1.0000
71735191|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.048|0.209|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.209|0.048|1.0000
71735192|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.11||||1|TWO_SIDED|95.0|0.054|0.243|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.243|0.054|1.0000
71735193|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9996|TWO_SIDED|95.0|0.113|0.547|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.547|0.113|0.9996
71773416|NCT04824365|143046775|SUPERIORITY||Mean Difference (Final Values)|1.704|STANDARD_ERROR_OF_MEAN|0.3035|<|0.0001|TWO_SIDED|95.0|1.105|2.302|||ANOVA|Two-way ANOVA||||2.302|1.105|<0.0001
71773417|NCT04824365|143046776|SUPERIORITY||Mean Difference (Final Values)|1.633|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|0.9672|2.298|||ANOVA|Two-way ANOVA||||2.298|0.9672|<0.0001
71773418|NCT04824365|143046777|SUPERIORITY||Mean Difference (Final Values)|1.964|STANDARD_ERROR_OF_MEAN|0.2473|<|0.0001|TWO_SIDED|95.0|1.477|2.452|||ANOVA|Two-way ANOVA||||2.452|1.477|<0.0001
71773419|NCT04824365|143046778|SUPERIORITY||Mean Difference (Final Values)|-0.4831|STANDARD_ERROR_OF_MEAN|0.2382||0.0435|TWO_SIDED|95.0|-0.9521|-0.01413|||ANOVA|Two-way ANOVA||||-0.01413|-0.9521|0.0435
71773420|NCT04824365|143046779|SUPERIORITY||Mean Difference (Final Values)|-0.05102|STANDARD_ERROR_OF_MEAN|0.2711||0.8509|TWO_SIDED|95.0|-0.5862|0.4841|||ANOVA|Two-way ANOVA||||0.4841|-0.5862|0.8509
71773421|NCT04824365|143046780|SUPERIORITY||Mean Difference (Final Values)|0.1339|STANDARD_ERROR_OF_MEAN|0.3177||0.6738|TWO_SIDED|95.0|-0.4921|0.76|||ANOVA|Two-way ANOVA||||0.7600|-0.4921|0.6738
71773422|NCT04824365|143046781|SUPERIORITY||Mean Difference (Final Values)|0.3095|STANDARD_ERROR_OF_MEAN|0.2832||0.2753|TWO_SIDED|95.0|-0.2478|0.8669|||ANOVA|Two-way ANOVA||||0.8669|-0.2478|0.2753
71773423|NCT04824365|143046782|SUPERIORITY||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.2636|<|0.0001|TWO_SIDED|95.0|-1.948|-0.9043|||ANOVA|Two-way ANOVA||||-0.9043|-1.948|<0.0001
71773424|NCT01052844|143046809|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).||||0.04
71773425|NCT01052844|143046810|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||We evaluated associations between categorical variables using the Chi-Square test||||0.06
71773426|NCT03463031|143046811|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
71773427|NCT03463031|143046812|SUPERIORITY||Least Square Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Models Analysis|||||-0.3|-1.0|<0.001
71773428|NCT03463031|143046813|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|< 0.001
71773429|NCT03463031|143046814|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.233|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.1|-0.6|0.233
71773430|NCT01068652|143046869|NON_INFERIORITY_OR_EQUIVALENCE|The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 \<0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens.|Mean Difference (Final Values)|0.11||||0.3406||95.0|-0.12|0.34|||ANCOVA|||To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated.||0.34|-0.12|0.3406
71773431|NCT00701376|143046902|SUPERIORITY||Mean Difference (Net)|-6.32||||0.03|TWO_SIDED|99.8|-15.6|2.94|||paired t-test|||||2.94|-15.6|0.03
71735194|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.29||||0.9991|TWO_SIDED|95.0|0.13|0.634|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.634|0.130|0.9991
71773432|NCT00701376|143046903|SUPERIORITY||Mean Difference (Net)|-7.56||||0.08|TWO_SIDED|99.8|-22.0|6.83|||Wilcoxon (Mann-Whitney)|||||6.83|-22.0|0.08
71773433|NCT00701376|143046904|SUPERIORITY||Mean Difference (Net)|5.84||||0.14|TWO_SIDED|99.8|-7.55|19.2|||paired t-test|||||19.2|-7.55|0.14
71773434|NCT00701376|143046906|SUPERIORITY||Mean Difference (Net)|-0.2|||<|0.001|TWO_SIDED|99.8|-0.38|-0.02|||paired t-test|||||-0.02|-0.38|<0.001
71773435|NCT00701376|143046907|SUPERIORITY||Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|99.8|-0.68|0.23|||paired t-test|||||0.23|-0.68|0.10
71773436|NCT00701376|143046908|SUPERIORITY||Mean Difference (Net)|-1.72||||0.21|TWO_SIDED|99.8|-8.68|5.25|||paired t-test|||||5.25|-8.68|0.21
71773437|NCT00701376|143046910|SUPERIORITY|||||||0.002|||||||Wilcoxon signed-rank test|||||||0.002
71773438|NCT00701376|143046911|SUPERIORITY|||||||0.04|||||||Wilcoxon signed-rank test|||||||0.04
71773439|NCT00701376|143046912|SUPERIORITY|||||||0.005|||||||Wilcoxon signed-rank test|||||||0.005
71832493|NCT03482635|143169157|OTHER||Difference of adjusted means|1.4|STANDARD_ERROR_OF_MEAN|10.6||0.894|TWO_SIDED|95.0|-19.6|22.4|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements.||22.4|-19.6|0.8940
71832494|NCT03482635|143169157|OTHER||Difference of adjusted means|1.0|STANDARD_ERROR_OF_MEAN|10.6||0.9241|TWO_SIDED|95.0|-20.0|22.1|||Mixed Models Analysis|||Restricted maximum likelihood (REML)-based repeated measures approach. The model included fixed, categorical effects of treatment, visit, and treatment by visit interaction, and stratification factors (prior biologic treatment failure and concomitant corticosteroid therapy at Visit 2/randomisation), as well as the continuous fixed covariates of baseline and baseline-by-visit interaction. An unstructured covariance structure was used to model the within-patient measurements||22.1|-20.0|0.9241
71832495|NCT05165485|143169167|SUPERIORITY||Mean Difference (Net)|-23.0||||0.22|TWO_SIDED|95.0|-61.0|14.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence, stopping after the first failure to reject the null hypothesis.|Mixed Models Analysis|Denominator degrees of freedom were approximated by the Kenward and Roger (1997) method.|Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|14|-61|0.22
71889640|NCT00928070|143300943|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
71735195|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.32||||0.9979|TWO_SIDED|95.0|0.149|0.682|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.682|0.149|0.9979
71735196|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.19||||1||95.0|0.091|0.417|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.417|0.091|1.0000
71735197|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9998|TWO_SIDED|95.0|0.119|0.539|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.539|0.119|0.9998
71735198|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9985|TWO_SIDED|95.0|0.141|0.666|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.666|0.141|0.9985
71773440|NCT00701376|143046913|SUPERIORITY|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
71773441|NCT02537574|143046923|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.264||0.94|TWO_SIDED|95.0|0.61|1.7|||Regression, Logistic|||||1.70|0.61|0.940
71773442|NCT02537574|143046923|SUPERIORITY||Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.207||0.383|TWO_SIDED|95.0|0.48|1.33|||Regression, Logistic|||||1.33|0.48|0.383
71773443|NCT03595774|143046941|SUPERIORITY|||||||0.0833||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0833
71773444|NCT03595774|143046942|SUPERIORITY|||||||0.0131||||||a priori threshold for statistical significance of P\<0.05|ANOVA|One-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.0131
71773445|NCT03595774|143046943|SUPERIORITY|||||||0.012728||||||a prior threshold for significant of P\<0.05|ANOVA|Two-way ANOVA for repeated measured followed by Holm-Šídák's multiple comparisons test||||||0.012728
71773446|NCT03595774|143046944|SUPERIORITY|||||||2e-08||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.00000002
71773447|NCT03595774|143046945|SUPERIORITY|||||||0.017215||||||a priori threshold for statistical significance of P\<0.05|ANOVA|Two-way ANOVA for repeated measures followed by Holm-Šídák's multiple comparisons test||||||0.017215
71773448|NCT01593722|143046949|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.68
71889641|NCT00928070|143300943|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
71735199|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9977|TWO_SIDED|95.0|0.162|0.73|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.730|0.162|0.9977
71735200|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.22||||0.9999|TWO_SIDED|95.0|0.105|0.468|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.468|0.105|0.9999
71735201|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.26||||0.9996|TWO_SIDED|95.0|0.119|0.57|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.570|0.119|0.9996
71735202|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.82||||0.6621|TWO_SIDED|95.0|0.319|2.136|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||2.136|0.319|0.6621
71735203|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.79||||0.7085|TWO_SIDED|95.0|0.324|1.847|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.847|0.324|0.7085
71735204|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.06||||1|TWO_SIDED|95.0|0.028|0.14|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||0.140|0.028|1.0000
71735205|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.1||||1|TWO_SIDED|95.0|0.043|0.216|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||0.216|0.043|1.0000
71735206|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.08||||1|TWO_SIDED|95.0|0.034|0.177|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||0.177|0.034|1.0000
71735207|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.2||||0.9998|TWO_SIDED|95.0|0.086|0.453|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||0.453|0.086|0.9998
71735208|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.17||||0.9999|TWO_SIDED|95.0|0.075|0.4|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||0.400|0.075|0.9999
71735209|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.4||||0.9863|TWO_SIDED|95.0|0.173|0.901|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||0.901|0.173|0.9863
71735210|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9998|TWO_SIDED|95.0|0.103|0.529|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||0.529|0.103|0.9998
71735211|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.28||||0.9992|TWO_SIDED|95.0|0.119|0.626|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||0.626|0.119|0.9992
71735212|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9995|TWO_SIDED|95.0|0.102|0.561|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||0.561|0.102|0.9995
71735213|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.31||||0.9964|TWO_SIDED|95.0|0.131|0.729|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||0.729|0.131|0.9964
71735214|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.25||||0.9995|TWO_SIDED|95.0|0.107|0.584|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||0.584|0.107|0.9995
71735215|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.24||||0.9993|TWO_SIDED|95.0|0.098|0.578|||Ratio of Active/Placebo|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||0.578|0.098|0.9993
71735216|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.34||||0.9781|TWO_SIDED|95.0|0.119|0.969|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours||0.969|0.119|0.9781
71735217|NCT01597635|142985739|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.38||||0.9375|TWO_SIDED|95.0|0.154|1.341|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.341|0.154|0.9375
71735218|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2598|TWO_SIDED|95.0|0.752|1.215|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.215|0.752|0.2598
71735219|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3949|TWO_SIDED|95.0|0.783|1.273|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.273|0.783|0.3949
71735220|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4175|TWO_SIDED|95.0|0.791|1.294|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.294|0.791|0.4175
71735221|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.442|TWO_SIDED|95.0|0.806|1.292|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.292|0.806|0.4420
71735222|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4432|TWO_SIDED|95.0|0.811|1.262|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.262|0.811|0.4432
71735223|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4578|TWO_SIDED|95.0|0.818|1.229|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.229|0.818|0.4578
71735224|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3365|TWO_SIDED|95.0|0.79|1.167|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.167|0.790|0.3365
71735225|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.163|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.163|0.770|0.3339
71735226|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3608|TWO_SIDED|95.0|0.786|1.166|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.166|0.786|0.3608
71735227|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3584|TWO_SIDED|95.0|0.788|1.168|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.168|0.788|0.3584
71735228|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1219|TWO_SIDED|95.0|0.725|1.073|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.073|0.725|0.1219
71735229|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4662|TWO_SIDED|95.0|0.814|1.21|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.210|0.814|0.4662
71773449|NCT02788474|143047008|OTHER||Adjusted mean difference|-0.00066|STANDARD_ERROR_OF_MEAN|0.00282||0.8146|TWO_SIDED|95.0|-0.00621|0.00488||random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)|random coefficient regression|The Kenward-Roger approximation was used to estimate denominators degrees of freedom.|Difference calculated as Nintedanib minus Placebo|"The rate of change (slope) in blood CRPM was assumed to be linear in each subject over the 12 weeks of treatment. The intercepts and slopes were assumed to be normally distributed with arbitrary covariance matrix.~Since the distribution of the data was not normal, a log10 transformation was performed before conducting the statistical analyses.~Significance tests were based on least-square means using 2-sided 95% confidence intervals (2-sided α=0.05)."||0.00488|-0.00621|0.8146
71773450|NCT02788474|143047009|OTHER||slope estimate|22.001||||0.2084|TWO_SIDED|95.0|-11.83|57.58|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in the Extracellular matrix (ECM) biomarker CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM and the monthly rate of change (slope) in blood CRPM in the first 12 weeks as covariates was applied for placebo-treated patients only to evaluate the potential of CRPM as a prognostic biomarker.||57.58|-11.83|0.2084
71773451|NCT02788474|143047009|OTHER||slope estimate|-45.566||||0.1537|TWO_SIDED|95.0|-109.55|16.37|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess how nintedanib treatment affected the association between disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death) and the change in CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM, the monthly rate of change (slope) in blood CRPM up to Week 12, treatment and treatment-CRPM slope interaction as covariates was applied.||16.37|-109.55|0.1537
71773452|NCT02788474|143047009|OTHER||Odds Ratio (OR)|0.769||||0.3116|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the overall treatment regimen affected disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM and randomised treatment as covariates was applied.||1.27|0.46|0.3116
71773453|NCT02788474|143047009|OTHER||Odds Ratio (OR)|0.772||||0.3175|TWO_SIDED|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the monthly rate of change (slope) in blood CRPM in the first 12 weeks could explain the effect of treatment on disease progression (as defined by absolute forced vital capacity (FVC) decline \>=10% or death), a logistic regression analysis including baseline blood CRPM, the rate of change (slope) in blood CRPM in the first 12 weeks and randomised treatment as covariates was applied.||1.27|0.46|0.3175
71773454|NCT02788474|143047010|OTHER||Adjusted mean difference|0.00121|STANDARD_ERROR_OF_MEAN|0.002||0.5469|TWO_SIDED|95.0|-0.00273|0.00515||random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C1M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00515|-0.00273|0.5469
71773455|NCT02788474|143047011|OTHER||Adjusted mean difference|-0.00307|STANDARD_ERROR_OF_MEAN|0.00262||0.2429|TWO_SIDED|95.0|-0.00823|0.00209||random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter-individual variability is modelled by a Variance-Components variance-covariance matrix.|"The rate of change (slope) in blood C3M was assumed to be linear in each subject over the 12 weeks of treatment.~Within-patient errors are modelled by an Unstructured variance-covariance matrix."||0.00209|-0.00823|0.2429
71773456|NCT01272284|143047012|SUPERIORITY_OR_OTHER_LEGACY||Proportion successful|85.4|||<|0.0001|ONE_SIDED|95.81|78.1||||Fisher Exact|||The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.|||78.1|<0.0001
71773457|NCT00048061|143047025|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.615||||0.045|TWO_SIDED|95.0|0.013|1.216|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.|||1.216|0.013|0.045
71889642|NCT00928070|143300945|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.34||0.0014|TWO_SIDED|95.0|-1.77|-0.43||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.43|-1.77|0.0014
71889643|NCT00928070|143300945|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.70|-2.10|<0.0001
71735230|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5748|TWO_SIDED|95.0|0.828|1.247|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.247|0.828|0.5748
71735231|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.4104|TWO_SIDED|95.0|0.786|1.204|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.204|0.786|0.4104
71735232|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5114|TWO_SIDED|95.0|0.817|1.246|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.246|0.817|0.5114
71660070|NCT02906930|142834482|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.5|<0.0001
71660071|NCT02906930|142834482|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
71660072|NCT02906930|142834483|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.5|-3.1|<0.0001
71660073|NCT02906930|142834483|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0866|TWO_SIDED|95.0|-1.9|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-1.9|0.0866
71660074|NCT02906930|142834483|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.8692|TWO_SIDED|95.0|-0.9|0.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.8|-0.9|0.8692
71660075|NCT02906930|142834483|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.2||||0.7075|TWO_SIDED|95.0|-1.0|0.6|||MMRM||Oral Semaglutide 3 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-1.0|0.7075
71735233|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4213|TWO_SIDED|95.0|0.783|1.2|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.200|0.783|0.4213
71735234|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2663|TWO_SIDED|95.0|0.731|1.132|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.132|0.731|0.2663
71735235|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2373|TWO_SIDED|95.0|0.72|1.142|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.142|0.720|0.2373
71735236|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2575|TWO_SIDED|95.0|0.721|1.149|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.149|0.721|0.2575
71735237|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2173|TWO_SIDED|95.0|0.708|1.127|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.127|0.708|0.2173
71735238|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2406|TWO_SIDED|95.0|0.717|1.143|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.143|0.717|0.2406
71735239|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2471|TWO_SIDED|95.0|0.721|1.151|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.151|0.721|0.2471
71889644|NCT00928070|143300946|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0002
71889645|NCT00928070|143300946|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
71889646|NCT00928070|143300948|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2511|TWO_SIDED|95.0|-0.39|0.1||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||0.10|-0.39|0.2511
71735240|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2585|TWO_SIDED|95.0|0.727|1.157|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.157|0.727|0.2585
71735241|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.3101|TWO_SIDED|95.0|0.737|1.17|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.170|0.737|0.3101
71735242|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2476|TWO_SIDED|95.0|0.727|1.16|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.160|0.727|0.2476
71773458|NCT00048061|143047025|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|0.297||||0.338|TWO_SIDED|95.0|-0.312|0.906|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control|||0.906|-0.312|0.338
71773459|NCT00048061|143047025|NON_INFERIORITY_OR_EQUIVALENCE|The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to -1 percentage point.|Mean Difference (Final Values)|1.0||||0.001|TWO_SIDED|95.0|0.395|1.605|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.|||1.605|0.395|0.001
71773460|NCT02869438|143047099|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0707|TWO_SIDED|95.0|-0.007|0.161|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||0.161|-0.007|0.0707
71773461|NCT02869438|143047099|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.7747|TWO_SIDED|95.0|-0.077|0.104|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||0.104|-0.077|0.7747
71773462|NCT02869438|143047099|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.0969|TWO_SIDED|95.0|-0.014|0.173|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||0.173|-0.014|0.0969
71773463|NCT02869438|143047099|SUPERIORITY||Mean Difference (Final Values)|0.057||||0.1558|TWO_SIDED|95.0|-0.022|0.135|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For average over Day 28, 56, and 84|||0.135|-0.022|0.1558
71773464|NCT02869438|143047100|SUPERIORITY||Mean Difference (Final Values)|-0.176||||0.2847|TWO_SIDED|95.0|-0.505|0.153|||Mixed Models Analysis|Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.||||0.153|-0.505|0.2847
71773465|NCT02869438|143047101|SUPERIORITY||Mean Difference (Final Values)|-101.0|||<|0.0001|TWO_SIDED|95.0|-118.9|-83.06|||Mixed Models Analysis|Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.||||-83.06|-118.9|<0.0001
71773466|NCT02869438|143047102|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.6384|TWO_SIDED|95.0|-0.049|0.08|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||0.08|-0.049|0.6384
71773467|NCT02869438|143047102|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.148|TWO_SIDED|95.0|-0.016|0.109|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||0.109|-0.016|0.148
71773468|NCT02869438|143047102|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.4959|TWO_SIDED|95.0|-0.049|0.101|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||0.101|-0.049|0.4959
71773469|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.8667|TWO_SIDED|95.0|-0.062|0.073|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 3|||0.073|-0.062|0.8667
71773470|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.2734|TWO_SIDED|95.0|-0.033|0.115|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 7|||0.115|-0.033|0.2734
71773471|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.7252|TWO_SIDED|95.0|-0.068|0.098|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 14|||0.098|-0.068|0.7252
71735243|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3887|TWO_SIDED|95.0|0.767|1.222|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.222|0.767|0.3887
71735244|NCT01597635|142985740|SUPERIORITY||Ratio of Active/Placebo|0.92||||0.2294|TWO_SIDED|95.0|0.749|1.146|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.146|0.749|0.2294
71735245|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8522|TWO_SIDED|95.0|0.916|1.234|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.234|0.916|0.8522
71735246|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5885|TWO_SIDED|95.0|0.89|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.164|0.890|0.5885
71735247|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8558|TWO_SIDED|95.0|0.94|1.23|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.230|0.940|0.8558
71735248|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.8374|TWO_SIDED|95.0|0.932|1.224|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hour||1.224|0.932|0.8374
71773472|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.0976|TWO_SIDED|95.0|-0.014|0.164|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 28|||0.164|-0.014|0.0976
71773473|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.6536|TWO_SIDED|95.0|-0.077|0.122|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 56|||0.122|-0.077|0.6536
71773474|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.0595|TWO_SIDED|95.0|-0.004|0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 84|||0.188|-0.004|0.0595
71773475|NCT02869438|143047103|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.1377|TWO_SIDED|95.0|-0.02|0.147|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||0.147|-0.02|0.1377
71773476|NCT02869438|143047104|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1604|TWO_SIDED|95.0|0.85|2.58|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3|||2.58|0.85|0.1604
71773477|NCT02869438|143047104|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.76|2.19|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7|||2.19|0.76|0.3400
71773478|NCT02869438|143047104|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0924|TWO_SIDED|95.0|0.93|2.7|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14|||2.70|0.93|0.0924
71773479|NCT02869438|143047104|SUPERIORITY||Odds Ratio (OR)|1.57||||0.1052|TWO_SIDED|95.0|0.91|2.71|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28|||2.71|0.91|0.1052
71773480|NCT02869438|143047104|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3271|TWO_SIDED|95.0|0.77|2.21|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56|||2.21|0.77|0.3271
71773481|NCT02869438|143047104|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3017|TWO_SIDED|95.0|0.77|2.29|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84|||2.29|0.77|0.3017
71889647|NCT00928070|143300948|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.0189|TWO_SIDED|95.0|-0.53|-0.05||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.||-0.05|-0.53|0.0189
71889648|NCT00928070|143300949|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% significance level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0010
71773482|NCT02869438|143047105|SUPERIORITY||Mean Difference (Final Values)|-0.293||||0.0024|TWO_SIDED|95.0|-0.481|-0.105|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 14|||-0.105|-0.481|0.0024
71773483|NCT02869438|143047105|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.0002|TWO_SIDED|95.0|-0.609|-0.195|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 28|||-0.195|-0.609|0.0002
71773484|NCT02869438|143047105|SUPERIORITY||Mean Difference (Final Values)|-0.312||||0.0117|TWO_SIDED|95.0|-0.554|-0.07|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 56|||-0.07|-0.554|0.0117
71773485|NCT02869438|143047105|SUPERIORITY||Mean Difference (Final Values)|-0.472||||0.0004|TWO_SIDED|95.0|-0.731|-0.213|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 84|||-0.213|-0.731|0.0004
71735249|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5886|TWO_SIDED|95.0|0.887|1.152|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.152|0.887|0.5886
71735250|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.7532|TWO_SIDED|95.0|0.918|1.18|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.180|0.918|0.7532
71735251|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7108|TWO_SIDED|95.0|0.906|1.179|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.179|0.906|0.7108
71735252|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7445|TWO_SIDED|95.0|0.918|1.19|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.190|0.918|0.7445
71735253|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3759|TWO_SIDED|95.0|0.863|1.115|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.115|0.863|0.3759
71735254|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.398|TWO_SIDED|95.0|0.859|1.118|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.118|0.859|0.3980
71735255|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3231|TWO_SIDED|95.0|0.849|1.103|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.103|0.849|0.3231
71735256|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.1245|TWO_SIDED|95.0|0.812|1.056|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.056|0.812|0.1245
71735257|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4631|TWO_SIDED|95.0|0.87|1.134|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.134|0.870|0.4631
71735258|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.1026|TWO_SIDED|95.0|0.801|1.047|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.047|0.801|0.1026
71735259|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.97||||0.3152|TWO_SIDED|95.0|0.85|1.101|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.101|0.850|0.3152
71735260|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.0762|TWO_SIDED|95.0|0.803|1.035|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.035|0.803|0.0762
71735261|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.0274||95.0|0.763|1.003|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.003|0.763|0.0274
71773486|NCT02869438|143047105|SUPERIORITY||Mean Difference (Final Values)|-0.395||||0.0002|TWO_SIDED|95.0|-0.603|-0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-0.188|-0.603|0.0002
71773487|NCT02869438|143047106|SUPERIORITY||Mean Difference (Final Values)|-7.229||||0.0001|TWO_SIDED|95.0|-10.832|-3.626|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 28|||-3.626|-10.832|0.0001
71773488|NCT02869438|143047106|SUPERIORITY||Mean Difference (Final Values)|-5.942||||0.0115|TWO_SIDED|95.0|-10.538|-1.346|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 56|||-1.346|-10.538|0.0115
71773489|NCT02869438|143047106|SUPERIORITY||Mean Difference (Final Values)|-8.599||||0.0004|TWO_SIDED|95.0|-13.3|-3.898|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 84|||-3.898|-13.3|0.0004
71773490|NCT02869438|143047106|SUPERIORITY||Mean Difference (Final Values)|-7.257||||0.0003|TWO_SIDED|95.0|-11.133|-3.38|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.|||-3.38|-11.133|0.0003
71773491|NCT02869438|143047107|SUPERIORITY||Mean Difference (Final Values)|5.414||||0.2825|TWO_SIDED|95.0|-4.492|15.321|||Mixed Models Analysis|Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.||||15.321|-4.492|0.2825
71889649|NCT00928070|143300951|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|STANDARD_ERROR_OF_MEAN|1.21||0.0001|TWO_SIDED|95.0|-7.04|-2.3||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.30|-7.04|0.0001
71735262|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.3594|TWO_SIDED|95.0|0.853|1.112|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.112|0.853|0.3594
71735263|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.7027|TWO_SIDED|95.0|0.906|1.197|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.197|0.906|0.7027
71735264|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8661|TWO_SIDED|95.0|0.941|1.246|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.246|0.941|0.8661
71735265|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.8084|TWO_SIDED|95.0|0.924|1.228|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.228|0.924|0.8084
71735266|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.9504|TWO_SIDED|95.0|0.976|1.3|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.300|0.976|0.9504
71735267|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.53|TWO_SIDED|95.0|0.871|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.164|0.871|0.5300
71735268|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8595|TWO_SIDED|95.0|0.942|1.243|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.243|0.942|0.8595
71735269|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.8802|TWO_SIDED|95.0|0.943|1.261|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.261|0.943|0.8802
71735270|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.11||||0.9232|TWO_SIDED|95.0|0.958|1.278|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.278|0.958|0.9232
71735271|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.07||||0.7911|TWO_SIDED|95.0|0.902|1.256|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.256|0.902|0.7911
71735272|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.28||||0.9946|TWO_SIDED|95.0|1.059|1.514|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.514|1.059|0.9946
71735273|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.983|TWO_SIDED|95.0|1.019|1.444|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.444|1.019|0.9830
71735274|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.8024|TWO_SIDED|95.0|0.91|1.261|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.261|0.910|0.8024
71773492|NCT02869438|143047117|SUPERIORITY||Mean Difference (Final Values)|-0.365||||0.012|TWO_SIDED|95.0|-0.649|-0.081|||Mixed Models Analysis|Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.|For Day 84|||-0.081|-0.649|0.0120
71735275|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4806|TWO_SIDED|95.0|0.843|1.166|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.166|0.843|0.4806
71735276|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6658|TWO_SIDED|95.0|0.869|1.223|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.223|0.869|0.6658
71735277|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.6131|TWO_SIDED|95.0|0.856|1.212|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.212|0.856|0.6131
71735278|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5795|TWO_SIDED|95.0|0.856|1.197|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.197|0.856|0.5795
71735279|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0209|TWO_SIDED|95.0|0.716|0.993|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||0.993|0.716|0.0209
71735280|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4823|TWO_SIDED|95.0|0.83|1.187|||Mixed Models Analysis|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.187|0.830|0.4823
71735281|NCT01597635|142985740|SUPERIORITY_OR_OTHER||0.0406|0.85||||0.0406|TWO_SIDED|95.0|0.703|1.021|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.021|0.703|0.0406
71735282|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5186|TWO_SIDED|95.0|0.844|1.169|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.169|0.844|0.5186
71773493|NCT02869438|143047118|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0018|TWO_SIDED|95.0|1.5|5.88|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.88|1.50|0.0018
71773494|NCT02869438|143047119|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0107|TWO_SIDED|95.0|1.24|5.09|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.||5.09|1.24|0.0107
71773495|NCT01013649|143047122|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.62|TWO_SIDED|95.0|0.79|1.38||One-sided significance level = 0.15|Log Rank||Reference level = Arm I|A total of 200 deaths between the arms will provide 80% power to detect a signal for an increase in median overall survival from 22 to 28.8 months and 90% power to detect a signal for an increase in median overall survival from 22 to 30.6 months (HRs of 0.76 and 0.72, respectively, in favor of the erlotinib arm) with the addition of erlotinib and a 1-sided alpha of 0.15||1.38|0.79|0.62
71773496|NCT01013649|143047123|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|90.0|0.79|1.18||One-sided significance level = 0.05.|Log Rank||Reference level = Arm III|316 deaths from step 2 randomized patients provides 80% power, with 0.05 1-sided alpha, to detect an OS increase (HR=0.76 in favor of arm IV), corresponding to increasing median OS from 17 to 22.5 months with the addition of RT. For analysis triggered by patients having 5 years potential follow-up from step 2 randomization, it is projected that at least 265 events will be observed, providing at least 72% power. The trigger used for the primary analysis was 5-years of follow-up (270 deaths).||1.18|0.79|0.38
71773497|NCT01013649|143047124|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.8|1.31|||||Reference level = Arm I|||1.31|0.80|
71773498|NCT01013649|143047125|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|90.0|0.68|0.99|||||Reference level = Arm III|||0.99|0.68|
71889650|NCT00928070|143300951|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.97|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-7.27|-2.66||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-2.66|-7.27|<0.0001
71735283|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.387|TWO_SIDED|95.0|0.824|1.132|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.132|0.824|0.3870
71735284|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.1281|TWO_SIDED|95.0|0.77|1.065|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.065|0.770|0.1281
71735285|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4754|TWO_SIDED|95.0|0.837|1.181|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.181|0.837|0.4754
71735286|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5627|TWO_SIDED|95.0|0.856|1.217|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.217|0.856|0.5627
71735287|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5552|TWO_SIDED|95.0|0.848|1.22|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.220|0.848|0.5552
71735288|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.503|TWO_SIDED|95.0|0.843|1.201|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.201|0.843|0.5030
71735289|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5558|TWO_SIDED|95.0|0.84|1.218|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.218|0.840|0.5558
71735290|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.2709|TWO_SIDED|95.0|0.769|1.135|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.135|0.769|0.2709
71735291|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4143|TWO_SIDED|95.0|0.795|1.208|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.208|0.795|0.4143
71773499|NCT03475875|143047144|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-7.7|-0.9|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||-0.9|-7.7|
71773500|NCT03475875|143047145|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|-4.7|1.0|||Linear Mixed Model|Kenward and Roger Method was used for the Degrees of Freedom|Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||1.0|-4.7|
71773501|NCT02017171|143047146|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.999|TWO_SIDED|95.0|-1.9|1.9||p value is not adjusted for multiple comparisons, a priori threshold for statistical significance: p\<0.05|linear model for correlated errors||Treatment difference = Allopurinol-Placebo|||1.9|-1.9|0.999
71773502|NCT02017171|143047147|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.6|2.2||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.2|-1.6|
71773503|NCT02017171|143047148|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||For secondary outcomes, 95% confidence intervals are reported, without P values. The confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||Treatment difference = Allopurinol - Placebo|||2.3|-1.7|
71773504|NCT02017171|143047149|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.5|0.4||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.4|-1.5|
71773505|NCT02017171|143047150|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.0|0.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Treatment difference = Allopurinol - Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||0.5|-1.0|
71660076|NCT02906930|142834483|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.0||||0.0138|TWO_SIDED|95.0|-1.8|-0.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.8|0.0138
71660077|NCT02906930|142834483|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.4|<0.0001
71660078|NCT02906930|142834506|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.45||||0.0043|TWO_SIDED|95.0|0.26|0.78||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.78|0.26|0.0043
71660079|NCT02906930|142834506|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.18|0.59||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.59|0.18|0.0002
71660080|NCT02906930|142834506|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|TWO_SIDED|95.0|0.19|0.6||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.60|0.19|0.0002
71660081|NCT02906930|142834507|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.03|TWO_SIDED|95.0|0.25|0.93||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.93|0.25|0.0300
71735292|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.7886|TWO_SIDED|95.0|0.891|1.348|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.348|0.891|0.7886
71735293|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.08||||0.7607|TWO_SIDED|95.0|0.885|1.353|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.353|0.885|0.7607
71735294|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.8677|TWO_SIDED|95.0|0.922|1.4|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.400|0.922|0.8677
71735295|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.7012|TWO_SIDED|95.0|0.847|1.302|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.302|0.847|0.7012
71735296|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5156|TWO_SIDED|95.0|0.805|1.23|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.230|0.805|0.5156
71735297|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3524|TWO_SIDED|95.0|0.783|1.178|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.178|0.783|0.3524
71735298|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.638|TWO_SIDED|95.0|0.845|1.292|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.292|0.845|0.6380
71735299|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.4003|TWO_SIDED|95.0|0.743|1.241|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.241|0.743|0.4003
71735300|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.16||||0.8817|TWO_SIDED|95.0|0.907|1.502|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.502|0.907|0.8817
71735301|NCT01597635|142985740|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.14||||0.8145|TWO_SIDED|95.0|0.804|1.505|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.505|0.804|0.8145
71735302|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6468|TWO_SIDED|95.0|0.765|1.321|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.321|0.765|0.6468
71735303|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1965|TWO_SIDED|95.0|0.658|1.136|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||1.136|0.658|0.1965
71735304|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.1681|TWO_SIDED|95.0|0.694|1.129|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.129|0.694|0.1681
71735305|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.0877|TWO_SIDED|95.0|0.669|1.075|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.075|0.669|0.0877
71735306|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2011|TWO_SIDED|95.0|0.715|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.159|0.715|0.2011
71735307|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6855|TWO_SIDED|95.0|0.842|1.345|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.345|0.842|0.6855
71735308|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.04||||0.6093|TWO_SIDED|95.0|0.8|1.325|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.325|0.800|0.6093
71735309|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.435|TWO_SIDED|95.0|0.765|1.253|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||1.253|0.765|0.4350
71889651|NCT00928070|143300952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.0035|TWO_SIDED|95.0|-0.56|-0.11||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: =\<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.11|-0.56|0.0035
71889652|NCT00928070|143300952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.21||0.7089|TWO_SIDED|95.0|-2.01|2.92||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: \>3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<3.5/day and \>3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||2.92|-2.01|0.7089
71889653|NCT00928070|143300952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: =\<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||-0.21|-0.61|<0.0001
71889654|NCT00928070|143300952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.47||0.7437|TWO_SIDED|95.0|-0.78|1.09||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: \>2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=\<2.5/day and \>2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.||1.09|-0.78|0.7437
71889655|NCT00928070|143300953|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0009
71889656|NCT00928070|143300953|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.||||0.0021
71889657|NCT00928070|143300955|SUPERIORITY_OR_OTHER||Least squares mean difference|-9.15|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-12.85|-5.45||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-5.45|-12.85|<0.0001
71889658|NCT00928070|143300955|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.03||0.0002|TWO_SIDED|95.0|-11.6|-3.61||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-3.61|-11.60|0.0002
71889659|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|8.17|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|4.09|12.25||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||12.25|4.09|<0.0001
71889660|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|6.96|STANDARD_ERROR_OF_MEAN|2.13||0.0012|TWO_SIDED|95.0|2.77|11.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||11.15|2.77|0.0012
71889661|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|4.0|STANDARD_ERROR_OF_MEAN|2.01||0.0472|TWO_SIDED|95.0|0.05|7.95||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.95|0.05|0.0472
71889662|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|2.46|STANDARD_ERROR_OF_MEAN|1.53||0.1087|TWO_SIDED|95.0|-0.55|5.46||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.46|-0.55|0.1087
71735310|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.2232|TWO_SIDED|95.0|0.722|1.195|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.195|0.722|0.2232
71735311|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2716|TWO_SIDED|95.0|0.733|1.2|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.200|0.733|0.2716
71735312|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.93||||0.2866|TWO_SIDED|95.0|0.726|1.19|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.190|0.726|0.2866
71735313|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.5033|TWO_SIDED|95.0|0.78|1.27|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.270|0.780|0.5033
71735314|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.1493|TWO_SIDED|95.0|0.684|1.12|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.120|0.684|0.1493
71735315|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4947|TWO_SIDED|95.0|0.759|1.301|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.301|0.759|0.4947
71735316|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.89||||0.1951|TWO_SIDED|95.0|0.678|1.161|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.161|0.678|0.1951
71735317|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.8||||0.0512|TWO_SIDED|95.0|0.612|1.05|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.050|0.612|0.0512
71660082|NCT02906930|142834507|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.13||||0.0001|TWO_SIDED|95.0|0.04|0.36||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.36|0.04|0.0001
71660083|NCT02906930|142834507|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.06||||0.0001|TWO_SIDED|95.0|0.01|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg /Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.01|0.0001
71660084|NCT01659866|142834534|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71660085|NCT01383135|142834539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||GraphPad (GraphPad Software, San Diego, Calif) was used for the paired two-sample t test and was performed to compare SUVmax values. P \< .05 was considered to indicate a significant difference|t-test, 2 sided|||Comparison made between baseline tumor values and tumor values 6-weeks post-bevacizumab therapy||||.034
71660086|NCT05084716|142834597|SUPERIORITY||Odds Ratio (OR)|5.03|||<|0.0001|TWO_SIDED|95.0|2.08|12.13|||Regression, Logistic|||||12.13|2.08|<.0001
71735318|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.47|TWO_SIDED|95.0|0.775|1.279|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.279|0.775|0.4700
71889663|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|5.79|STANDARD_ERROR_OF_MEAN|1.77||0.0012|TWO_SIDED|95.0|2.31|9.28||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.28|2.31|0.0012
71889664|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|9.04|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|4.75|13.33||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||13.33|4.75|<0.0001
71889665|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|5.32|STANDARD_ERROR_OF_MEAN|2.22||0.0169|TWO_SIDED|95.0|0.96|9.67||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.67|0.96|0.0169
71889666|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.1||0.0546|TWO_SIDED|95.0|-0.08|8.17||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||8.17|-0.08|0.0546
71889667|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|2.35|STANDARD_ERROR_OF_MEAN|1.63||0.1497|TWO_SIDED|95.0|-0.85|5.55||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.55|-0.85|0.1497
71889668|NCT00928070|143300957|SUPERIORITY_OR_OTHER||Least squares mean difference|5.53|STANDARD_ERROR_OF_MEAN|1.88||0.0034|TWO_SIDED|95.0|1.84|9.23||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||9.23|1.84|0.0034
71889669|NCT00928070|143300958|SUPERIORITY_OR_OTHER||Least squares mean difference|16.25|STANDARD_ERROR_OF_MEAN|2.96|<|0.0001|TWO_SIDED|95.0|10.43|22.08||Statistical testing, two-sided, was done at 5% significance level.|ANOVA|||ANOVA model with treatment and center as factors was used to calculate p-value.||22.08|10.43|<0.0001
71889670|NCT00928070|143300959|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.||||<0.0001
71889671|NCT00928070|143300961|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2788|TWO_SIDED|95.0|-0.51|0.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.||0.15|-0.51|0.2788
71889672|NCT00928070|143300962|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0||||0.0021|TWO_SIDED|95.0|0.0|8.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||8.00|0.00|0.0021
71889673|NCT00928070|143300962|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.0|||<|0.0001|TWO_SIDED|95.0|3.0|11.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.||11.00|3.00|<0.0001
71889674|NCT02411448|143300978|OTHER||Hazard Ratio (HR)|0.591|||<|0.0001|TWO_SIDED|95.0|0.461|0.76|||Log Rank|||||0.760|0.461|<0.0001
71889675|NCT02411448|143300980|OTHER||Hazard Ratio (HR)|0.832||||0.4209|TWO_SIDED|95.0|0.532|1.303|||Log Rank|||||1.303|0.532|0.4209
71889676|NCT02411448|143300981|OTHER|||||||0.7413|||||||Cochran-Mantel-Haenszel|||||||0.7413
71889677|NCT02411448|143300982|OTHER|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
71889678|NCT02411448|143300983|OTHER||Hazard Ratio (HR)|0.619||||0.0003|TWO_SIDED|95.0|0.477|0.805|||Log Rank|||||0.805|0.477|0.0003
71889679|NCT01110395|143301000|OTHER|Bland and Altman|Mean + SD|0.05|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|||||Bland Altman|mean + SD|Bland Altman|We have provided all the information that is available to us. The PI has left the institution and we are unable to contact him. We have no further data to correct the errors.|We are unable to provide any further data that has been requested. We have supplied all the data that we can possibly provide because the PI has left the institution and we are unable to contact him. We have no other data.|There are no other statistical analysis. We have provided all the information that is available to us. We have no other data available to us because the PI has left the institution and we are unable to contact him.|||
71660087|NCT05084716|142834597|SUPERIORITY||Odds Ratio (OR)|7.6|||<|0.0001|TWO_SIDED|95.0|3.48|16.59|||Regression, Logistic|||||16.59|3.48|<.0001
71660088|NCT05084716|142834598|SUPERIORITY||Odds Ratio (OR)|12.88|||<|0.0001|TWO_SIDED|95.0|5.96|27.85|||Regression, Logistic|||||27.85|5.96|<.0001
71660089|NCT05084716|142834598|SUPERIORITY||Odds Ratio (OR)|1.78||||0.001|TWO_SIDED|95.0|1.26|2.52|||Regression, Logistic|||||2.52|1.26|.001
71660090|NCT05084716|142834599|SUPERIORITY||Cohen's d for difference in proportions|1.28|||<|0.0001|TWO_SIDED|||||Odds Ratio is undefined and p-value from Fisher's Exact test is reported because 0% of PrEP users had ≥80% medication coverage pre-intervention.|Fisher Exact|||||||<.0001
71660091|NCT05084716|142834599|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.34|||Regression, Logistic|||||0.34|0.16|<.0001
71660092|NCT04380090|142834651|SUPERIORITY||Odds Ratio (OR)|1.37||||0.41|TWO_SIDED|95.0|0.65|2.86|||Regression, Logistic||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.86|0.65|0.41
71735319|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.634|TWO_SIDED|95.0|0.811|1.368|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.368|0.811|0.6340
71735320|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2129|TWO_SIDED|95.0|0.689|1.183|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.183|0.689|0.2129
71735321|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6418|TWO_SIDED|95.0|0.798|1.411|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.411|0.798|0.6418
71735322|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4797|TWO_SIDED|95.0|0.754|1.315|||Ratio of Active/Placebo|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.315|0.754|0.4797
71735323|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.2659|TWO_SIDED|95.0|0.703|1.199|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.199|0.703|0.2659
71735324|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.2102|TWO_SIDED|95.0|0.687|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.159|0.687|0.2102
71735325|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.3623|TWO_SIDED|95.0|0.74|1.24|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.240|0.740|0.3623
71735326|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.3499|TWO_SIDED|95.0|0.73|1.225|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.225|0.730|0.3499
71773506|NCT02017171|143047151|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.5|2.9||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||2.9|0.5|
71735327|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.6494|TWO_SIDED|95.0|0.787|1.377|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.377|0.787|0.6494
71735328|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5567|TWO_SIDED|95.0|0.766|1.358|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.358|0.766|0.5567
71735329|NCT01597635|142985741|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.85||||0.1095|TWO_SIDED|95.0|0.615|1.073|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.073|0.615|0.1095
71660093|NCT04380090|142834652|SUPERIORITY||Odds Ratio (OR)|0.79||||0.66|TWO_SIDED|95.0|0.28|2.24|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||2.24|0.28|0.66
71660094|NCT04380090|142834653|SUPERIORITY||Odds Ratio (OR)|1.28||||0.65|TWO_SIDED|95.0|0.45|3.63|||ordinal regression model||OR for Propylene Glycol use (vs Docusate Sodium), adjusted for operative time and sex (female vs. male)|||3.63|0.45|0.65
71660095|NCT04380090|142834654|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.47|||||||Chi-squared|||||||0.47
71660096|NCT04380090|142834655|EQUIVALENCE|Equivalence is defined as a p-value greater or equal to 0.05 (no difference between groups)||||||0.99|||||||Fisher Exact|||||||0.99
71660097|NCT04795908|142834659|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.1997|||||||ANOVA|||||||0.1997
71660098|NCT04795908|142834660|NON_INFERIORITY|looking for statistical significant differences between groups||||||0.076|||||||ANOVA|||||||0.076
71660099|NCT04795908|142834661|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.6228|||||||ANOVA|||||||0.6228
71660100|NCT04795908|142834662|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8984|||||||ANOVA|||||||0.8984
71660101|NCT04795908|142834663|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.8188|||||||ANOVA|||||||0.8188
71660102|NCT04795908|142834664|NON_INFERIORITY|Looking for statistically significant differences between groups||||||0.0288|||||||ANOVA|||||||0.0288
71660103|NCT04795908|142834665|NON_INFERIORITY|looking for statistically significant differences between groups||||||0.0524|||||||ANOVA|||||||0.0524
71660104|NCT02800213|142834675|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.280
71660105|NCT00536263|142834682|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.008||||0.86|TWO_SIDED|95.0|-0.063|0.079||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.079|-0.063|0.860
71735330|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6098|TWO_SIDED|95.0|0.721|1.644|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours||1.644|0.721|0.6098
71773507|NCT02017171|143047152|SUPERIORITY||Ratio (Final Values)|1.4|||||TWO_SIDED|95.0|1.0|1.8||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||1.8|1.0|
71660106|NCT00536263|142834682|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.061|0.217||P-values are unadjusted; Hochberg's adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."||0.217|0.061|<0.001
71735331|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.35||||0.9441|TWO_SIDED|95.0|0.931|2.068|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour||2.068|0.931|0.9441
71660107|NCT00536263|142834682|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority of PEG 1.5 mcg/kg\*24 weeks with respect to PEG 1.5 mcg/kg\*48 weeks was to be concluded if the lower bound of the one-sided 95% confidence interval of the difference of the rates (PEG 1.5 mcg/kg\*24 weeks minus PEG 1.5 mcg/kg\*48 weeks) was greater than the noninferiority margin of -10%.|Pairwise rate difference|-0.132|||||TWO_SIDED|90.0|-0.198|-0.065||||||||-0.065|-0.198|
71735332|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.7173|TWO_SIDED|95.0|0.749|1.621|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours||1.621|0.749|0.7173
71735333|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.8292|TWO_SIDED|95.0|0.81|1.949|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours||1.949|0.810|0.8292
71735334|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.8008|TWO_SIDED|95.0|0.775|1.832|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours||1.832|0.775|0.8008
71735335|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.2||||0.7905|TWO_SIDED|95.0|0.776|1.799|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours||1.799|0.776|0.7905
71889680|NCT01110395|143301000|OTHER||||||<|0.05|||||||Mean + SD|||||||<0.05
71660108|NCT00536263|142834683|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.011||||0.7|TWO_SIDED|95.0|-0.074|0.052|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.052|-0.074|0.700
71889681|NCT00862251|143301001|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least-square means|-14.76|||<|0.001|TWO_SIDED|95.0|-19.61|-9.91|||Longitudinal data analysis (LDA)|||||-9.91|-19.61|<0.001
71889682|NCT00862251|143301002|SUPERIORITY_OR_OTHER_LEGACY||Percent change in Least Square Means|-13.62|||<|0.001|TWO_SIDED|95.0|-20.44|-6.79|||Longitudinal data analysis (LDA)|||||-6.79|-20.44|<0.001
71889683|NCT00862251|143301003|SUPERIORITY_OR_OTHER_LEGACY||Percent change in least squares mean|-15.73|||<|0.001|TWO_SIDED|95.0|-22.65|-8.81|||Longitudinal Data Analysis (LDA)|||||-8.81|-22.65|<0.001
71889684|NCT00862251|143301004|SUPERIORITY_OR_OTHER_LEGACY||Percent Change in Least Squares Means|-3.81||||0.06|TWO_SIDED|95.0|-7.78|0.17|||Longitudinal Data Analysis|||||0.17|-7.78|0.060
71889685|NCT00862251|143301005|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.5|6.2|||Regression, Logistic|||||6.2|2.5|<0.001
71889686|NCT00862251|143301005|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.6|||Regression, Logistic|||||2.6|1.3|<0.001
71889687|NCT00862251|143301006|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.3|8.5|||Regression, Logistic|||||8.5|2.3|<0.001
71889688|NCT00862251|143301007|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|1.9|6.6|||Regression, Logistic|||||6.6|1.9|<0.001
71889689|NCT00862251|143301008|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.33|||<|0.001|TWO_SIDED|95.0|-11.38|-5.28|||Longitudinal data analysis (LDA)|||||-5.28|-11.38|<0.001
71889690|NCT00862251|143301008|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.63||||0.039|TWO_SIDED|95.0|-5.13|-0.13|||Longitudinal data analysis (LDA)|||||-0.13|-5.13|0.039
71889691|NCT00862251|143301009|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.88||||0.316|TWO_SIDED|95.0|-8.53|2.77|||Longitudinal data analysis (LDA)|||||2.77|-8.53|0.316
71889692|NCT00862251|143301009|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.16||||0.356|TWO_SIDED|95.0|-6.75|2.43|||Longitudinal data analysis (LDA)|||||2.43|-6.75|0.356
71889693|NCT00862251|143301010|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.47||||0.756|TWO_SIDED|95.0|-2.5|3.45|||Longitudinal data analysis (LDA)|||||3.45|-2.50|0.756
71889694|NCT00862251|143301010|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-0.52||||0.675|TWO_SIDED|95.0|-2.96|1.92|||Longitudinal data analysis (LDA)|||||1.92|-2.96|0.675
71889695|NCT00862251|143301011|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-15.93|-7.31|||Longitudinal data analysis (LDA)|||||-7.31|-15.93|<0.001
71889696|NCT00862251|143301011|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.18||||0.078|TWO_SIDED|95.0|-6.71|0.35|||Longitudinal data analysis (LDA)|||||0.35|-6.71|0.078
71889697|NCT00862251|143301012|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-14.16|||<|0.001|TWO_SIDED|95.0|-20.23|-8.1|||Longitudinal data analysis (LDA)|||||-8.10|-20.23|<0.001
71889698|NCT00862251|143301012|SUPERIORITY_OR_OTHER_LEGACY||Least Sqares Mean Difference|-2.56||||0.313|TWO_SIDED|95.0|-7.53|2.41|||Longitudinal data analysis (LDA)|||||2.41|-7.53|0.313
71889699|NCT00862251|143301013|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.17|||<|0.001|TWO_SIDED|95.0|-12.1|-4.23|||Longitudinal data analysis (LDA)|||||-4.23|-12.10|<0.001
71889700|NCT00862251|143301013|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.83||||0.266|TWO_SIDED|95.0|-5.05|1.4|||Longitudinal data analysis (LDA)|||||1.40|-5.05|0.266
71889701|NCT00862251|143301014|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.45|||<|0.001|TWO_SIDED|95.0|-17.16|-5.75|||Longitudinal data analysis (LDA)|||||-5.75|-17.16|<0.001
71889702|NCT00862251|143301014|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.13||||0.371|TWO_SIDED|95.0|-6.81|2.54|||Longitudinal data analysis (LDA)|||||2.54|-6.81|0.371
71889703|NCT00862251|143301015|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.01|||<|0.001|TWO_SIDED|95.0|-11.46|-4.56|||Longitudinal data analysis (LDA)|||||-4.56|-11.46|<0.001
71889704|NCT00862251|143301015|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.95||||0.041|TWO_SIDED|95.0|-5.78|-0.12|||Longitudinal data analysis (LDA)|||||-0.12|-5.78|0.041
71773508|NCT02017171|143047153|SUPERIORITY||Ratio (Final Values)|1.3|||||TWO_SIDED|95.0|1.0|1.6||For secondary outcomes, 95% confidence intervals are reported, without P values.|||||Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|1.6|1.0|
71773509|NCT02017171|143047154|SUPERIORITY||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|4.5||For secondary outcomes, 95% confidence intervals are reported, without P values.|||Hazard Ratio = Allopurinol / Placebo. Confidence intervals are not adjusted for multiplicity and should not be used to infer treatment effects.|||4.5|0.8|
71773510|NCT03091777|143047167|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71773511|NCT03091777|143047167|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71773512|NCT02220998|143047182|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.|Difference in proportions|5.2|||||TWO_SIDED|95.0|0.2|10.3|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||10.3|0.2|
71773513|NCT02220998|143047182|SUPERIORITY_OR_OTHER|||||||0.018||||||P-value was stratified by cirrhosis status and prior treatment experience.|Cochran-Mantel-Haenszel|||The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of -10%).||||0.018
71773514|NCT02314143|143047190|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.224|4.459|||Cochran-Mantel-Haenszel||The odds ratio for dabrafenib followed by combination therapy versus combination therapy has been presented.|||4.459|0.224|1.0000
71773515|NCT02314143|143047190|OTHER||Odds Ratio (OR)|1.97||||0.4216|TWO_SIDED|95.0|0.382|10.166|||Cochran-Mantel-Haenszel||The odds ratio for trametinib followed by combination therapy versus combination therapy has been presented.|||10.166|0.382|0.4216
71773516|NCT00873860|143047202|SUPERIORITY_OR_OTHER|||||||0.573||||||Change at Day 92: p-value was based on analysis of variance (ANOVA).|ANOVA|||||||0.573
71773517|NCT00873860|143047202|SUPERIORITY_OR_OTHER|||||||0.64||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.640
71773518|NCT00873860|143047202|SUPERIORITY_OR_OTHER|||||||0.224||||||Change at Day 92: p-value was based on ANOVA.|ANOVA|||||||0.224
71773519|NCT00873860|143047203|SUPERIORITY_OR_OTHER|||||||0.4686||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.4686
71773520|NCT00873860|143047203|SUPERIORITY_OR_OTHER|||||||0.317||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3170
71889705|NCT00862251|143301016|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.57||||0.218|TWO_SIDED|95.0|-0.93|4.06|||Longitudinal data analysis (LDA)|||||4.06|-0.93|0.218
71889706|NCT00862251|143301016|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.22||||0.832|TWO_SIDED|95.0|-2.27|1.83|||Longitudinal data analysis (LDA)|||||1.83|-2.27|0.832
71889707|NCT00862251|143301017|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.91|||<|0.001|TWO_SIDED|95.0|-13.36|-4.47|||Longitudinal data analysis (LDA)|||||-4.47|-13.36|<0.001
71889708|NCT00862251|143301017|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.52||||0.175|TWO_SIDED|95.0|-6.17|1.13|||Longitudinal data analysis (LDA)|||||1.13|-6.17|0.175
71889709|NCT00862251|143301018|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.78||||0.749|TWO_SIDED|95.0|-19.88|14.32|||Longitudinal data analysis (LDA)|||||14.32|-19.88|0.749
71889710|NCT00862251|143301018|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|4.69||||0.494|TWO_SIDED|95.0|-8.73|18.1|||Longitudinal data analysis (LDA)|||||18.10|-8.73|0.494
71889711|NCT00891995|143301025|SUPERIORITY_OR_OTHER|||||||0.49||||||One-sided p-value.|ANCOVA|Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.||||||0.49
71889712|NCT00891995|143301028|SUPERIORITY_OR_OTHER|||||||0.4||||||One-sided p-value|ANCOVA|Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis||||||0.40
71889713|NCT02054702|143301034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.||||<0.0001
71889714|NCT02054702|143301034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.||||<0.0001
71889715|NCT02054702|143301035|SUPERIORITY_OR_OTHER|||||||0.4244|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.||||0.4244
71889716|NCT02054702|143301035|SUPERIORITY_OR_OTHER|||||||0.7623|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.||||0.7623
71660109|NCT00536263|142834683|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.125|TWO_SIDED|95.0|-0.014|0.123|||Cochran-Mantel-Haenszel|Stratified by genotype||||0.123|-0.014|0.125
71735336|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7566|TWO_SIDED|95.0|0.737|1.958|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.958|0.737|0.7566
71735337|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.8349|TWO_SIDED|95.0|0.812|2.05|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours||2.050|0.812|0.8349
71735338|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.4739|TWO_SIDED|95.0|0.713|1.527|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.527|0.713|0.4739
71735339|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6291|TWO_SIDED|95.0|0.763|1.647|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours||1.647|0.763|0.6291
71735340|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.18||||0.8032|TWO_SIDED|95.0|0.83|1.814|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours||1.814|0.830|0.8032
71735341|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.325|TWO_SIDED|95.0|0.626|1.416|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours||1.416|0.626|0.3250
71735342|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5828|TWO_SIDED|95.0|0.687|1.63|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours||1.630|0.687|0.5828
71735343|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.4546|TWO_SIDED|95.0|0.661|1.512|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours||1.512|0.661|0.4546
71735344|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.06||||0.6158|TWO_SIDED|95.0|0.719|1.639|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours||1.639|0.719|0.6158
71735345|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.7748|TWO_SIDED|95.0|0.752|1.77|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours||1.770|0.752|0.7748
71660110|NCT00536263|142834683|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.065|||||TWO_SIDED|90.0|-0.122|-0.008||||||||-0.008|-0.122|
71660111|NCT00536263|142834684|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.016||||0.598|TWO_SIDED|95.0|-0.078|0.047|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.047|-0.078|0.598
71660112|NCT00536263|142834684|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.041||||0.24|TWO_SIDED|95.0|-0.027|0.108|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.108|-0.027|0.24
71660113|NCT00536263|142834684|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.056|||||TWO_SIDED|90.0|-0.112|-0.001||||||End of treatment||-0.001|-0.112|
71660114|NCT00536263|142834684|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.006||||0.83|TWO_SIDED|95.0|-0.075|0.063|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.063|-0.075|0.830
71735346|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.6565|TWO_SIDED|95.0|0.686|1.714|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours||1.714|0.686|0.6565
71735347|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.87||||0.2773|TWO_SIDED|95.0|0.566|1.38|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.380|0.566|0.2773
71735348|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.3606|TWO_SIDED|95.0|0.61|1.467|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours||1.467|0.610|0.3606
71735349|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.2211|TWO_SIDED|95.0|0.555|1.317|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours||1.317|0.555|0.2211
71773521|NCT00873860|143047203|SUPERIORITY_OR_OTHER|||||||0.1664||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.1664
71773522|NCT00873860|143047203|SUPERIORITY_OR_OTHER|||||||0.3234||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3234
71889717|NCT02054702|143301036|SUPERIORITY_OR_OTHER|||||||0.8759|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.8759
71889718|NCT02054702|143301036|SUPERIORITY_OR_OTHER|||||||0.2176|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.||||0.2176
71889719|NCT02054702|143301037|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.||||0.8420
71889720|NCT02054702|143301037|SUPERIORITY_OR_OTHER|||||||0.3781|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.||||0.3781
71889721|NCT02054702|143301038|SUPERIORITY_OR_OTHER|||||||0.1807|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.||||0.1807
71889722|NCT02054702|143301038|SUPERIORITY_OR_OTHER|||||||0.2802|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.||||0.2802
71889723|NCT02054702|143301039|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.||||0.8622
71889724|NCT02054702|143301039|SUPERIORITY_OR_OTHER|||||||0.4848|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.||||0.4848
71889725|NCT02054702|143301040|SUPERIORITY_OR_OTHER|||||||0.8588|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.||||0.8588
71889726|NCT02054702|143301040|SUPERIORITY_OR_OTHER|||||||0.9928|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.||||0.9928
71889727|NCT02054702|143301041|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.||||<0.0001
71889728|NCT02054702|143301041|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.||||<0.0001
71735350|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.286|TWO_SIDED|95.0|0.587|1.348|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours||1.348|0.587|0.2860
71832496|NCT05165485|143169168|SUPERIORITY||Mean Difference (Net)|-9.0|||||TWO_SIDED|95.0|-38.0|20.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The OTE is defined as the average of the Day 30, Day 60, and Day 85 Revefenacin - Tiotropium Least Squares Mean differences. The null hypothesis was that the OTE Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|20|-38|
71832497|NCT05165485|143169169|SUPERIORITY||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|-29.0|32.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|32|-29|
71832498|NCT05165485|143169170|SUPERIORITY||Mean Difference (Net)|-6.0|||||TWO_SIDED|95.0|-40.0|29.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|29|-40|
71832499|NCT05165485|143169171|SUPERIORITY||Mean Difference (Net)|-41.0|||||TWO_SIDED|95.0|-118.0|35.0||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Mixed Models Analysis||Revefenacin - Tiotropium Least Squares Mean Difference.|The null hypothesis was that the Revefenacin - Tiotropium Least Squares Mean Difference was zero and the alternative hypothesis was that it was nonzero.|The Revefenacin - Tiotropium Least Squares Mean Difference was estimated by fitting a repeated measures mixed model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FVC, screening FVC, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|35|-118|
71735351|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.4079|TWO_SIDED|95.0|0.609|1.51|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours||1.510|0.609|0.4079
71735352|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.02||||0.5284|TWO_SIDED|95.0|0.614|1.663|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours||1.663|0.614|0.5284
71735353|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.3586|TWO_SIDED|95.0|0.568|1.458|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours||1.458|0.568|0.3586
71832500|NCT05165485|143169172|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.39|0.92||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Logistic||The profile likelihood method was used to estimate the Revefenacin / Tiotropium responder OR.|The null hypothesis was that the Revefenacin / Tiotropium responder Odds Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium responder OR was estimated by fitting a logistic regression model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|0.92|0.39|
71889729|NCT02054702|143301044|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.||||<0.0001
71660115|NCT00536263|142834684|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.13||||0.001|TWO_SIDED|95.0|0.053|0.208|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.208|0.053|0.001
71773523|NCT00873860|143047203|SUPERIORITY_OR_OTHER|||||||0.3133||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.3133
71773524|NCT00873860|143047203|SUPERIORITY_OR_OTHER|||||||0.2108||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.||||0.2108
71773525|NCT00873860|143047210|SUPERIORITY_OR_OTHER|||||||0.934||||||ACQ score \<=0.75, Day 92: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.934
71773526|NCT00873860|143047210|SUPERIORITY_OR_OTHER|||||||0.592||||||ACQ score \<=0.75, Day 169: Fisher exact test was used to compare all arms.|Fisher Exact|||||||0.592
71773527|NCT00873860|143047215|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
71889730|NCT02054702|143301044|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.||||<0.0001
71773528|NCT00873860|143047215|SUPERIORITY_OR_OTHER|||||||0.6022||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||0.6022
71773529|NCT00873860|143047215|SUPERIORITY_OR_OTHER|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
71773530|NCT00873860|143047215|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
71889731|NCT02054702|143301045|SUPERIORITY_OR_OTHER|||||||0.0392|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.||||0.0392
71889732|NCT02054702|143301045|SUPERIORITY_OR_OTHER|||||||0.9716|TWO_SIDED||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.||||0.9716
71889733|NCT02304926|143301060|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889734|NCT02304926|143301061|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889735|NCT02304926|143301062|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889736|NCT02304926|143301063|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71889737|NCT02304926|143301064|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71889738|NCT02304926|143301065|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889739|NCT02304926|143301066|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889740|NCT02304926|143301067|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889741|NCT02304926|143301068|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889742|NCT02304926|143301069|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889743|NCT02304926|143301070|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889744|NCT02304926|143301071|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889745|NCT02304926|143301072|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889746|NCT02304926|143301073|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889747|NCT02304926|143301074|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889748|NCT02304926|143301075|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889749|NCT02304926|143301076|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889750|NCT02304926|143301077|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71889751|NCT02304926|143301078|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889752|NCT02304926|143301079|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71889753|NCT00109473|143301102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.02
71889754|NCT02706938|143301125|OTHER|One tail paired t test.|Mean Difference (Final Values)|1.3267|STANDARD_DEVIATION|2.1604||0.0002|TWO_SIDED|95.0|0.6263|2.027||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||2.0270|0.6263|0.0002
71889755|NCT02706938|143301125|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.359||||0.0082|TWO_SIDED|95.0|-0.6255|-0.0924||A priori threshold for statistical significance was 0.05|McNemar|||||-0.0924|-0.6255|0.0082
71889756|NCT02706938|143301126|OTHER|One tail paired t test.|Mean Difference (Final Values)|-6.9131|STANDARD_DEVIATION|32.5093||0.099|TWO_SIDED|95.0|-17.5987|3.7724||A priori threshold for statistical significance was 0.05|t-test, 1 sided|||||3.7724|-17.5987|0.099
71889757|NCT02706938|143301126|OTHER|McNemar's chi squared statistic|Risk Difference (RD)|-0.0263||||0.8084|TWO_SIDED|95.0|-0.2651|0.2125||A priori threshold for statistical significance was 0.05|McNemar|||||0.2125|-0.2651|0.8084
71889758|NCT01838044|143301128|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.287||0.6012|TWO_SIDED|95.0|-0.72|0.42|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between two study arms.||0.42|-0.72|0.6012
71889759|NCT01838044|143301129|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|||<|0.0001|TWO_SIDED|95.0|1.02|1.83|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.||1.83|1.02|<0.0001
71889760|NCT01838044|143301130|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.361||0.5128|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.||0.95|-0.48|0.5128
71773531|NCT00873860|143047215|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
71773532|NCT00873860|143047215|SUPERIORITY_OR_OTHER|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact|||||||1.0000
71773533|NCT00873860|143047216|SUPERIORITY_OR_OTHER|||||||0.551||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.551
71773534|NCT00873860|143047216|SUPERIORITY_OR_OTHER|||||||0.492||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.492
71773535|NCT00873860|143047216|SUPERIORITY_OR_OTHER|||||||0.983||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.983
71773536|NCT00873860|143047216|SUPERIORITY_OR_OTHER|||||||0.991||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.991
71773537|NCT00873860|143047216|SUPERIORITY_OR_OTHER|||||||0.9||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.900
71773538|NCT00873860|143047216|SUPERIORITY_OR_OTHER|||||||0.673||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test|||||||0.673
71773539|NCT00873860|143047217|SUPERIORITY_OR_OTHER|||||||0.546||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.546
71773540|NCT00873860|143047217|SUPERIORITY_OR_OTHER|||||||0.534||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.534
71773541|NCT00873860|143047217|SUPERIORITY_OR_OTHER|||||||0.847||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.847
71773542|NCT00873860|143047217|SUPERIORITY_OR_OTHER|||||||0.987||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.987
71773543|NCT00873860|143047217|SUPERIORITY_OR_OTHER|||||||0.992||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.992
71773544|NCT00873860|143047217|SUPERIORITY_OR_OTHER|||||||0.688||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||||||0.688
71832501|NCT05165485|143169173|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.69|1.45||The familywise type 1 error rate is controlled at 0.05 by testing the primary and secondary endpoint hypotheses in sequence and stopping after the first failure to reject the null hypothesis. Accordingly, the p-value is not shown.|Regression, Cox||The profile likelihood method was used to estimate the Revefenacin / Tiotropium HR.|The null hypothesis was that the Revefenacin / Tiotropium CompEx Event Hazard Ratio was equal to 1 and the alternative hypothesis was that it was not equal to 1.|The Revefenacin / Tiotropium HR was estimated by fitting a Cox proportional hazards model which included terms for participant, treatment, 6 categorical covariates, and 3 continuous covariates: baseline FEV1, screening FEV1, and baseline PIFR. The 6 categorical covariates were reversibility to ipratropium status (reversible/not reversible), smoking status (current/former), concomitant LABA or LABA/ICS use (Yes/No), GOLD airflow category (3/4, i.e., postipratropium FEV1 % predicted \< 30%/≥ 30%), sex (woman/man), and age group (\< 65/≥ 65).|1.45|0.69|
71832502|NCT01780298|143169183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.278|||<|0.0001|TWO_SIDED|95.0|-42.203|-30.352|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-30.352|-42.203|<0.0001
71832503|NCT01780298|143169183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.739|||<|0.0001|TWO_SIDED|95.0|-38.418|-27.06|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-27.060|-38.418|<0.0001
71832504|NCT01780298|143169183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.265|||<|0.0001|TWO_SIDED|95.0|-31.081|-19.449|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-19.449|-31.081|<0.0001
71832505|NCT01780298|143169183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.538||||0.1504|TWO_SIDED|95.0|-8.398|1.321|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1.321|-8.398|0.1504
71832506|NCT01780298|143169183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.474||||0.0002|TWO_SIDED|95.0|-11.207|-3.741|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-3.741|-11.207|0.0002
71832507|NCT01780298|143169183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.013|||<|0.0001|TWO_SIDED|95.0|-15.979|-6.046|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-6.046|-15.979|<0.0001
71832508|NCT01780298|143169184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.611|||<|0.0001|TWO_SIDED|95.0|-32.249|-22.973|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||-22.973|-32.249|<0.0001
71832509|NCT01780298|143169184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.553|||<|0.0001|TWO_SIDED|95.0|-29.501|-19.604|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||-19.604|-29.501|<0.0001
71832510|NCT01780298|143169184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.107|||<|0.0001|TWO_SIDED|95.0|-19.043|-9.17|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||-9.170|-19.043|<0.0001
71832511|NCT01780298|143169184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.058||||0.0983|TWO_SIDED|95.0|-6.702|0.585|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.585|-6.702|0.0983
71832512|NCT01780298|143169184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.446|||<|0.0001|TWO_SIDED|95.0|-13.845|-7.047|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||-7.047|-13.845|<0.0001
71832513|NCT01780298|143169184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.504|||<|0.0001|TWO_SIDED|95.0|-17.302|-9.707|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||-9.707|-17.302|<0.0001
71832514|NCT01780298|143169185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.448|||<|0.0001|TWO_SIDED|95.0|28.374|52.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||52.521|28.374|<0.0001
71832515|NCT01780298|143169185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.538|||<|0.0001|TWO_SIDED|95.0|14.89|38.185|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||38.185|14.890|<0.0001
71832516|NCT01780298|143169185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.661||||0.0018|TWO_SIDED|95.0|7.997|33.324|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||33.324|7.997|0.0018
71773545|NCT00708071|143047220|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25||||0.143||95.0|-0.04|0.49|||McNemar||Difference in Proportions = SoC - FS VH S/D 4|||0.49|-0.04|0.143
71773546|NCT00708071|143047221|SUPERIORITY_OR_OTHER||Difference in proportions|0.31|||||TWO_SIDED|90.0|0.12|0.48|||||Difference in proportions = SoC - FS VH S/D 4|||0.48|0.12|
71773547|NCT00708071|143047222|SUPERIORITY_OR_OTHER||Difference in proportions|0.111|||||TWO_SIDED|90.0|-0.11|0.32|||||Difference in proportions = SoC - FS VH S/D 4|||0.32|-0.11|
71773548|NCT00708071|143047223|SUPERIORITY_OR_OTHER||Difference in proportions|-0.032|||||TWO_SIDED|90.0|-0.24|0.18|||||Difference in proportions = SoC - FS VH S/D 4|||0.18|-0.24|
71773549|NCT00708071|143047224|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|90.0|-0.21|0.21|||||Difference in proportions = SoC - FS VH S/D 4|||0.21|-0.21|
71773550|NCT00708071|143047225|SUPERIORITY_OR_OTHER||Difference in proportions|0.038|||||TWO_SIDED|90.0|-0.17|0.24|||||Difference in proportions = SoC - FS VH S/D 4|||0.24|-0.17|
71773551|NCT00708071|143047226|SUPERIORITY_OR_OTHER|||||||0.645|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.645
71832517|NCT01780298|143169185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.91||||0.0015|TWO_SIDED|95.0|5.534|22.286|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||22.286|5.534|0.0015
71660116|NCT00536263|142834684|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.136||||||90.0|-0.201|-0.071||||||24 weeks after EOT||-0.071|-0.201|
71832518|NCT01780298|143169185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.877||||0.1847|TWO_SIDED|95.0|-2.886|14.639|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||14.639|-2.886|0.1847
71832519|NCT01780298|143169185|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.787||||0.0003|TWO_SIDED|95.0|9.536|30.038|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||30.038|9.536|0.0003
71773552|NCT00708071|143047227|SUPERIORITY_OR_OTHER|||||||0.103||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.103
71773553|NCT00708071|143047228|SUPERIORITY_OR_OTHER|||||||0.833||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.833
71832520|NCT01780298|143169186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2979.725||||0.1981|TWO_SIDED|95.0|-7560.258|1600.808|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1600.808|-7560.258|0.1981
71832521|NCT01780298|143169186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2317.131||||0.1956|TWO_SIDED|95.0|-1224.786|5859.048|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||5859.048|-1224.786|0.1956
71832522|NCT01780298|143169186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2396.589||||0.2077|TWO_SIDED|95.0|-1367.692|6160.87|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||6160.870|-1367.692|0.2077
71889761|NCT01838044|143301132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7251|TWO_SIDED|95.0|-0.22|0.32|||Mixed Models Analysis|||Statistical analysis at Week 5 based on comparison between treatment groups.||0.32|-0.22|0.7251
71889762|NCT01838044|143301132|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1255|TWO_SIDED|95.0|-0.06|0.46|||Mixed Models Analysis|||Statistical analysis at Week 10 based on comparison between treatment groups.||0.46|-0.06|0.1255
71889763|NCT01838044|143301134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.317||0.2856|TWO_SIDED|95.0|-0.97|0.29|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between treatment groups.||0.29|-0.97|0.2856
71889764|NCT01838044|143301134|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.363||0.3987|TWO_SIDED|95.0|-1.02|0.41|||Mixed Models Analysis|||Statistical analysis at Week 10 compared between treatment groups.||0.41|-1.02|0.3987
71773554|NCT00708071|143047229|SUPERIORITY_OR_OTHER|||||||0.501||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.501
71773555|NCT00708071|143047230|SUPERIORITY_OR_OTHER|||||||0.247||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.247
71773556|NCT00708071|143047231|SUPERIORITY_OR_OTHER|||||||0.715||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.715
71773557|NCT00708071|143047233|SUPERIORITY_OR_OTHER|||||||0.754||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.754
71773558|NCT00708071|143047234|SUPERIORITY_OR_OTHER|||||||0.388||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.388
71773559|NCT00708071|143047235|SUPERIORITY_OR_OTHER|||||||0.234||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.234
71773560|NCT00708071|143047236|SUPERIORITY_OR_OTHER|||||||0.688||90.0||||Two-sided Wilcoxon paired sample tests|Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
71773561|NCT00708071|143047237|SUPERIORITY_OR_OTHER|||||||0.625||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.625
71773562|NCT00708071|143047238|SUPERIORITY_OR_OTHER|||||||0.688||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.688
71773563|NCT00708071|143047239|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
71773564|NCT00708071|143047240|SUPERIORITY_OR_OTHER|||||||0.521||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.521
71773565|NCT00708071|143047241|SUPERIORITY_OR_OTHER|||||||0.324||90.0||||alpha = 10%|Two-sided Wilcoxon paired sample tests|||||||0.324
71773566|NCT00708071|143047242|SUPERIORITY_OR_OTHER|||||||0.661||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.661
71773567|NCT00708071|143047243|SUPERIORITY_OR_OTHER|||||||1||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||1.000
71773568|NCT00708071|143047244|SUPERIORITY_OR_OTHER|||||||0.699||90.0|||||Two-sided Wilcoxon paired sample tests|alpha = 10%||||||0.699
71773569|NCT00708071|143047247|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||two-sided paired t-test|alpha = 5%||||||0.0010
71660117|NCT00536263|142834685|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.072||||0.076|TWO_SIDED|95.0|-0.007|0.151|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.151|-0.007|0.076
71660118|NCT00536263|142834685|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.135||||0.001|TWO_SIDED|95.0|0.053|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.053|0.001
71889765|NCT00860470|143301151|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.95||||0.36|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.06|0.86|0.36
71889766|NCT00860470|143301152|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.78|TWO_SIDED|95.0|0.88|1.2|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.20|0.88|0.78
71889767|NCT00860470|143301153|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.04|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.04|0.63|0.11
71889768|NCT00860470|143301154|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.89||||0.02|TWO_SIDED|95.0|0.81|0.99|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.99|0.81|0.02
71889769|NCT00860470|143301155|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.80|<0.001
71832523|NCT01780298|143169186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5296.856||||0.1154|TWO_SIDED|95.0|-11930.19|1336.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||1336.478|-11930.190|0.1154
71660119|NCT00536263|142834685|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.063|||||TWO_SIDED|90.0|-0.135|0.009||||||End of treatment||0.009|-0.135|
71832524|NCT01780298|143169186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-79.458||||0.8095|TWO_SIDED|95.0|-736.151|577.234|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||577.234|-736.151|0.8095
71889770|NCT00860470|143301156|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.75||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.97|0.57|0.03
71889771|NCT00860470|143301157|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||<|0.001|TWO_SIDED|95.0|0.62|0.86|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.86|0.62|<0.001
71889772|NCT00860470|143301158|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.87||||0.87|TWO_SIDED|95.0|0.81|0.93|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.93|0.81|0.87
71889773|NCT00860470|143301159|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88|||<|0.001|TWO_SIDED|95.0|0.85|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||0.91|0.85|<0.001
71889774|NCT00860470|143301160|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.98||||0.13|TWO_SIDED|95.0|0.96|1.01|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.|||1.01|0.96|0.13
71889775|NCT02928952|143301165|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.153|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.153
71889776|NCT02928952|143301165|SUPERIORITY|Assessed group by time differences from week 12 to week 24. Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.026|||||||Mixed Models Analysis|Adjusted for age and duration of diabetes.||||||0.026
71889777|NCT02928952|143301165|SUPERIORITY|Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.012|||||||Mixed Models Analysis|Models adjusted for age and duration of diabetes.||Within group analysis of intervention effect on Diabetes Distress (Problem Areas in Diabetes, PAID scale) over time stratified by hemoglobin A1c\<8.5% and =/\>8.5.||||0.012
71889778|NCT02928952|143301166|SUPERIORITY|The statistical analysis was applied to both groups.||||||0.604|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||.604
71889779|NCT02928952|143301167|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.911|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.911
71889780|NCT02928952|143301168|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.94|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||||||0.940
71889781|NCT02928952|143301169|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.305|||||||Mixed Models Analysis|All models adjusted for Age and Duration of Diabetes||The statistical analysis was applied to both groups.||||0.305
71889782|NCT02928952|143301170|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.228|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||||||0.228
71889783|NCT02928952|143301171|SUPERIORITY|Statistical Test of hypothesis. Differing sample sizes are due to attrition and missed research visits. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.671|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.671
71889784|NCT02928952|143301172|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.571|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.571
71889785|NCT02928952|143301173|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.003|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.003
71889786|NCT02928952|143301174|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.632|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.632
71889787|NCT02928952|143301175|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.219|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.219
71889788|NCT02928952|143301176|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.931|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.931
71660120|NCT00536263|142834685|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.017||||0.662|TWO_SIDED|95.0|-0.058|0.092|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.092|-0.058|0.662
71832525|NCT01780298|143169186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5376.314||||0.1113|TWO_SIDED|95.0|-12030.714|1278.085|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||1278.085|-12030.714|0.1113
71832526|NCT01780298|143169187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.015|||<|0.0001|TWO_SIDED|95.0|4.51|7.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||7.521|4.510|<0.0001
71832527|NCT01780298|143169187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.845|||<|0.0001|TWO_SIDED|95.0|3.379|6.31|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||6.310|3.379|<0.0001
71832528|NCT01780298|143169187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.454|||<|0.0001|TWO_SIDED|95.0|1.923|4.984|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||4.984|1.923|<0.0001
71832529|NCT01780298|143169187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.171||||0.0418|TWO_SIDED|95.0|0.045|2.296|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||2.296|0.045|0.0418
71735354|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.13||||0.6768|TWO_SIDED|95.0|0.672|1.853|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours||1.853|0.672|0.6768
71735355|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.77||||0.1574|TWO_SIDED|95.0|0.488|1.39|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours||1.390|0.488|0.1574
71735356|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.39|TWO_SIDED|95.0|0.521|1.584|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.584|0.521|0.3900
71735357|NCT01597635|142985742|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.05||||0.5915|TWO_SIDED|95.0|0.748|1.516|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours||1.516|0.748|0.5915
71735358|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.06828|TWO_SIDED|95.0|0.528|1.501|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.501|0.528|0.06828
71735359|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.96||||0.5674|TWO_SIDED|95.0|0.57|1.609|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.609|0.570|0.5674
71735360|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.66||||0.8855|TWO_SIDED|95.0|0.321|1.316|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.316|0.321|0.8855
71735361|NCT01597635|142985745|SUPERIORITY||Ratio of Active/Placebo|0.97||||0.5358|TWO_SIDED|95.0|0.531|1.76|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.760|0.531|0.5358
71735362|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.17||||0.699|TWO_SIDED|95.0|0.622|2.155|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.155|0.622|0.6990
71735363|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.513|TWO_SIDED|95.0|0.549|1.721|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.721|0.549|0.5130
71660121|NCT00536263|142834685|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.139|||<|0.001|TWO_SIDED|95.0|0.059|0.22|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.220|0.059|<0.001
71660122|NCT00536263|142834685|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.122|||||TWO_SIDED|90.0|-0.191|-0.053||||||24 weeks after EOT||-0.053|-0.191|
71660123|NCT00536263|142834686|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.019||||0.373|TWO_SIDED|95.0|-0.023|0.061|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.061|-0.023|0.373
71660124|NCT00536263|142834686|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.049||||0.04|TWO_SIDED|95.0|0.003|0.096|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.096|0.003|0.040
71660125|NCT00536263|142834686|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.03|||||TWO_SIDED|90.0|-0.072|0.011||||||End of treatment||0.011|-0.072|
71660126|NCT00536263|142834686|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.969|TWO_SIDED|95.0|-0.041|0.043|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.043|-0.041|0.969
71660127|NCT00536263|142834686|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.045||||0.074|TWO_SIDED|95.0|-0.004|0.094|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.094|-0.004|0.074
71660128|NCT00536263|142834686|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.044|||||TWO_SIDED|90.0|-0.085|-0.003||||||24 weeks after EOT||-0.003|-0.085|
71660129|NCT00536263|142834687|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.019|-0.027|0.724
71660130|NCT00536263|142834687|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.243|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.048|-0.012|0.243
71660131|NCT00536263|142834687|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||End of treatment||0.002|-0.046|
71660132|NCT00536263|142834687|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004||||0.724|TWO_SIDED|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.019|-0.027|0.724
71660133|NCT00536263|142834687|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.018||||0.232|TWO_SIDED|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.048|-0.012|0.232
71660134|NCT00536263|142834687|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.022|||||TWO_SIDED|90.0|-0.046|0.002||||||24 weeks after EOT||0.002|-0.046|
71735364|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.73||||0.7696|TWO_SIDED|95.0|0.3|1.731|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.731|0.300|0.7696
71660135|NCT00536263|142834688|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.056||||0.219|TWO_SIDED|95.0|-0.033|0.145|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.145|-0.033|0.219
71660136|NCT00536263|142834688|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.126||||0.006|TWO_SIDED|95.0|0.037|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.216|0.037|0.006
71660137|NCT00536263|142834688|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.071|||||TWO_SIDED|90.0|-0.148|0.006||||||End of treatment||0.006|-0.148|
71660138|NCT00536263|142834688|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.082||||0.067|TWO_SIDED|95.0|-0.004|0.168|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.168|-0.004|0.067
71660139|NCT00536263|142834688|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.18|||<|0.001|TWO_SIDED|95.0|0.092|0.268|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.268|0.092|<0.001
71660140|NCT00536263|142834688|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.098|||||TWO_SIDED|90.0|-0.174|-0.021||||||24 weeks after EOT||-0.021|-0.174|
71660141|NCT00536263|142834689|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.001||||0.995|TWO_SIDED|95.0|-0.039|0.041|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.041|-0.039|0.995
71660142|NCT00536263|142834689|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.054||||0.031|TWO_SIDED|95.0|0.005|0.103|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.103|0.005|0.031
71660143|NCT00536263|142834689|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.053|||||TWO_SIDED|90.0|-0.094|-0.012||||||End of treatment||-0.012|-0.094|
71660144|NCT00536263|142834689|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.024||||0.389|TWO_SIDED|95.0|-0.03|0.078|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.078|-0.030|0.389
71660145|NCT00536263|142834689|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.121|||<|0.001|TWO_SIDED|95.0|0.058|0.184|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.184|0.058|<0.001
71660146|NCT00536263|142834689|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.097|||||TWO_SIDED|90.0|-0.152|-0.041||||||24 weeks after EOT||-0.041|-0.152|
71660147|NCT00536263|142834690|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.991|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.012|-0.012|0.991
71660148|NCT00536263|142834690|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.181|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.033|-0.006|0.181
71660149|NCT00536263|142834690|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||End of treatment||0.003|-0.030|
71660150|NCT00536263|142834690|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0||||0.971|TWO_SIDED|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.012|-0.012|0.971
71660151|NCT00536263|142834690|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.013||||0.179|TWO_SIDED|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.033|-0.006|0.179
71660152|NCT00536263|142834690|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.013|||||TWO_SIDED|90.0|-0.03|0.003||||||24 weeks after EOT||0.003|-0.030|
71660153|NCT00536263|142834691|SUPERIORITY_OR_OTHER|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||End of treatment||||0.991
71660154|NCT00536263|142834691|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.004||||0.322|TWO_SIDED|95.0|-0.004|0.013|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment||0.013|-0.004|0.322
71660155|NCT00536263|142834691|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.004|||||TWO_SIDED|90.0|-0.012|0.003||||||End of treatment||0.003|-0.012|
71660156|NCT00536263|142834691|SUPERIORITY_OR_OTHER|||||||0.991||95.0|||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference \& corresponding 95% confidence interval were not applicable."||24 weeks after EOT||||0.991
71889789|NCT02928952|143301177|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.627|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.627
71660157|NCT00536263|142834691|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.009||||0.157|TWO_SIDED|95.0|-0.003|0.021|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT||0.021|-0.003|0.157
71660158|NCT00536263|142834691|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.009|||||TWO_SIDED|90.0|-0.019|0.001||||||24 weeks after EOT||0.001|-0.019|
71735365|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.51||||0.9254|TWO_SIDED|95.0|0.203|1.289|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.289|0.203|0.9254
71735366|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.72||||0.7088|TWO_SIDED|95.0|0.216|2.419|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.419|0.216|0.7088
71735367|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.47||||0.8787|TWO_SIDED|95.0|0.112|1.69|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.690|0.112|0.8787
71735368|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7338|TWO_SIDED|95.0|0.714|1.197|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.197|0.714|0.7338
71735369|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.0||||0.4955|TWO_SIDED|95.0|0.703|1.415|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.415|0.703|0.4955
71889790|NCT02928952|143301178|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.6|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.60
71889791|NCT02928952|143301179|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.461|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.461
71889792|NCT02928952|143301180|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.906|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.906
71660159|NCT00536263|142834692|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.014
71889793|NCT02928952|143301181|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.856|||||||Mixed Models Analysis|All models were adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.856
71889794|NCT02928952|143301182|SUPERIORITY|Statistical Test of hypothesis. Analyzed as intention to treat in mixed models with imputation as last value moved forward.||||||0.89|||||||Mixed Models Analysis|All models adjusted for age and duration of diabetes.||The statistical analysis was applied to both groups.||||0.89
71889795|NCT00723957|143301183|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04|||||ONE_SIDED|90.0||1.41|||Regression, Cox|||||1.41||
71889796|NCT00723957|143301183|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5735|||||||Log Rank|||P-value is 1-sided||||0.5735
71889797|NCT00723957|143301184|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||ONE_SIDED|90.0||1.1|||Regression, Cox|||||1.10||
71889798|NCT00723957|143301184|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Log Rank|||P-value is 1-sided||||0.1750
71889799|NCT00723957|143301185|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||ONE_SIDED|90.0||1.15|||Regression, Cox|||||1.15||
71889800|NCT00723957|143301185|SUPERIORITY_OR_OTHER_LEGACY|||||||0.316|ONE_SIDED||||||Log Rank|||P-value is 1-sided||||0.316
71889801|NCT00723957|143301191|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||ONE_SIDED|90.0||2.1|||Regression, Cox||β3T+ subgroup|||2.10||
71889802|NCT00723957|143301191|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||0.9|||Regression, Cox||β3T- subgroup|||0.90||
71889803|NCT00723957|143301191|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.1|||||ONE_SIDED|90.0||1.4|||Regression, Cox||Overall population|||1.40||
71889804|NCT00706628|143301192|SUPERIORITY_OR_OTHER|||||||0.0577|||||||Fisher Exact|||||||0.0577
71889805|NCT00706628|143301192|SUPERIORITY_OR_OTHER|||||||0.0863|||||||Fisher Exact|||||||0.0863
71889806|NCT00706628|143301194|SUPERIORITY_OR_OTHER||Slope|1.4823|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|1.1754|1.7892||||||||1.7892|1.1754|
71889807|NCT01264939|143301206|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.52|||<|0.0001|TWO_SIDED|95.0|-5.97|-3.08||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.08|-5.97|<0.0001
71889808|NCT01264939|143301207|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.02|||<|0.0001|TWO_SIDED|95.0|-13.17|-6.86||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-6.86|-13.17|<0.0001
71889809|NCT01264939|143301208|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.72|-4.07||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.07|-7.72|<0.0001
71660160|NCT00536263|142834692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||<0.001
71660161|NCT00536263|142834692|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|comparison of post-treatment versus baseline values||||||0.010
71773570|NCT00708071|143047249|SUPERIORITY_OR_OTHER||Difference in proportions|0.182||||0.014|TWO_SIDED|95.0|0.04|0.34|||McNemar's test of paired proportions|Alpha = 5%|Difference in Proportions = (Number of SoC Participants with Hematoma/Seroma) - (Number of FS VH S/D 4 Participants with Hematoma/Seroma)|||0.34|0.04|0.014
71773571|NCT02140775|143047255|SUPERIORITY|||||||0.602|||||||Chi-squared|degrees of freedom = 1||A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.||||.602
71773572|NCT02140775|143047256|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-7.75|0.26|||t-test, 2 sided|||||0.26|-7.75|.066
71773573|NCT02140775|143047257|SUPERIORITY||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|7.68||0.674|TWO_SIDED|95.0|-18.59|12.09|||t-test, 2 sided|||||12.09|-18.59|.674
71660162|NCT00536263|142834692|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.2|0.631
71773574|NCT00945854|143047258|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
71773575|NCT01231230|143047276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||< 0.001
71773576|NCT01231230|143047276|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||<0.001
71773577|NCT01231230|143047276|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||mean difference from baseline relative to placebo||||>0.05
71773578|NCT05063318|143047358|SUPERIORITY||Least-squares geometric mean ratio|272.73|||||TWO_SIDED|90.0|213.22|348.86|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||348.86|213.22|
71832530|NCT01780298|143169187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.391||||0.0357|TWO_SIDED|95.0|0.096|2.686|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||2.686|0.096|0.0357
71832531|NCT01780298|143169187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.562||||0.0001|TWO_SIDED|95.0|1.303|3.82|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||3.820|1.303|0.0001
71832532|NCT01780298|143169188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|39.633|||<|0.0001|TWO_SIDED|95.0|33.964|45.302|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||45.302|33.964|<0.0001
71735370|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5264|TWO_SIDED|95.0|0.541|1.788|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.788|0.541|0.5264
71735371|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.91||||0.6183|TWO_SIDED|95.0|0.454|1.742|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.742|0.454|0.6183
71735372|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.03||||0.5291|TWO_SIDED|95.0|0.483|2.118|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.118|0.483|0.5291
71735373|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.09||||0.74|TWO_SIDED|95.0|0.828|1.448|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.448|0.828|0.7400
71735374|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.25||||0.9375|TWO_SIDED|95.0|0.937|1.683|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.683|0.937|0.9375
71735375|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9118|TWO_SIDED|95.0|0.896|1.771|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.771|0.896|0.9118
71735376|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.43||||0.9217|TWO_SIDED|95.0|0.866|2.382|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.382|0.866|0.9217
71735377|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.48||||0.8676|TWO_SIDED|95.0|0.73|3.064|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||3.064|0.730|0.8676
71735378|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.83||||0.8835|TWO_SIDED|95.0|0.609|1.135|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.135|0.609|0.8835
71735379|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.98||||0.5446|TWO_SIDED|95.0|0.723|1.33|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.330|0.723|0.5446
71735380|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.95||||0.6267|TWO_SIDED|95.0|0.679|1.333|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.333|0.679|0.6267
71735381|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.88||||0.7668|TWO_SIDED|95.0|0.612|1.26|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.260|0.612|0.7668
71735382|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.94||||0.61|TWO_SIDED|95.0|0.588|1.509|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.509|0.588|0.6100
71735383|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.68||||0.8159|TWO_SIDED|95.0|0.291|1.623|||Bayesian repeated measures model|||Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.623|0.291|0.8159
71735384|NCT01597635|142985745|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.53||||0.7988|TWO_SIDED|95.0|0.106|2.657|||Bayesian repeated measures model|||Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.657|0.106|0.7988
71735385|NCT01597635|142985746|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6536|TWO_SIDED|95.0|0.626|2.024|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||2.024|0.626|0.6536
71735386|NCT01597635|142985746|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.3||||0.9066|TWO_SIDED|95.0|0.876|1.955|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.955|0.876|0.9066
71735387|NCT01597635|142985746|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.23||||0.7859|TWO_SIDED|95.0|0.723|2.066|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.066|0.723|0.7859
71735388|NCT01597635|142985746|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.9||||0.6058|TWO_SIDED|95.0|0.413|1.963|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.963|0.413|0.6058
71735389|NCT01597635|142985746|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.29||||0.6921|TWO_SIDED|95.0|0.456|3.632|||Ratio of Active/Placebo|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||3.632|0.456|0.6921
71735390|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.92||||0.7934|TWO_SIDED|95.0|0.737|1.14|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.140|0.737|0.7934
71735391|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.01||||0.5205|TWO_SIDED|95.0|0.782|1.317|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.317|0.782|0.5205
71735392|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.12||||0.6682|TWO_SIDED|95.0|0.673|1.865|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||1.865|0.673|0.6682
71735393|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.99||||0.5304|TWO_SIDED|95.0|0.744|1.315|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||1.315|0.744|0.5304
71735394|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|0.81||||0.9078|TWO_SIDED|95.0|0.582|1.112|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||1.112|0.582|0.9078
71660163|NCT00536263|142834692|SUPERIORITY_OR_OTHER||Pairwise rate difference|-0.3||||0.617|TWO_SIDED|95.0|-1.4|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.||||0.8|-1.4|0.617
71660164|NCT00536263|142834692|SUPERIORITY_OR_OTHER||Pairwise rate difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1||||||||1.1|-1.1|
71660165|NCT03055650|142834716|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Week 1||||<0.0001
71660166|NCT03055650|142834716|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change from Baseline in Meibomian Gland Secretion Total Score at Month 1||||<0.0001
71660167|NCT03055650|142834717|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Week 1||||<0.0001
71660168|NCT03055650|142834717|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.05.||Change From Baseline in Tear Break-Up Time (TBUT) at Month 1||||<0.0001
71832533|NCT01780298|143169188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.792|||<|0.0001|TWO_SIDED|95.0|29.761|41.822|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||41.822|29.761|<0.0001
71832534|NCT01780298|143169188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.167|||<|0.0001|TWO_SIDED|95.0|23.445|34.888|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||34.888|23.445|<0.0001
71832535|NCT01780298|143169188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.842||||0.0418|TWO_SIDED|95.0|0.147|7.536|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||7.536|0.147|0.0418
71832536|NCT01780298|143169188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.625||||0.0084|TWO_SIDED|95.0|1.763|11.487|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||11.487|1.763|0.0084
71832537|NCT01780298|143169188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.467|||<|0.0001|TWO_SIDED|95.0|5.888|15.045|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||15.045|5.888|<0.0001
71889810|NCT01264939|143301209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99|||<|0.0001|TWO_SIDED|95.0|1.47|2.68||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||2.68|1.47|<0.0001
71889811|NCT01264939|143301210|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71889812|NCT01264939|143301211|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71889813|NCT01264939|143301212|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.25|-3.96||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.96|-7.25|<0.0001
71832538|NCT01780298|143169189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.929|||<|0.0001|TWO_SIDED|95.0|0.654|1.203|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.203|0.654|<0.0001
71660169|NCT03055650|142834718|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Week 1||||<0.0001
71660170|NCT03055650|142834718|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||Change From Baseline in Standard Patient Evaluation of Eye Dryness (SPEED) Total Score at Month 1||||<0.0001
71660171|NCT03055650|142834719|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Statistical significance is set at α = 0.025.||||||<0.0001
71660172|NCT01898650|142834732|SUPERIORITY|||||||0.004||||||no adjustments for multiple comparisons were made. the threshold for significance was set a priori at 0.05.|t-test, 1 sided|||Null hypothesis was that blood flow would be equivalent on the unaffected and affected sides.||||0.004
71660173|NCT04156620|142834750|SUPERIORITY||Marginal difference|17.91|||<|0.0001|TWO_SIDED|95.0|10.12|25.71|||Regression, Logistic|||Week 16||25.71|10.12|<0.0001
71660174|NCT04156620|142834751|SUPERIORITY||Marginal difference|20.45|||<|0.0001|TWO_SIDED|95.0|14.45|26.44|||Regression, Logistic|||||26.44|14.45|<0.0001
71660175|NCT04156620|142834752|SUPERIORITY||LS mean change|-1.01|STANDARD_ERROR_OF_MEAN|0.189|<|0.0001|TWO_SIDED|95.0|-1.38|-0.64|||Mixed Models Analysis|||Week 16||-0.64|-1.38|<0.0001
71660176|NCT04156620|142834753|SUPERIORITY||Marginal difference|22.15|||<|0.0001|TWO_SIDED|95.0|14.36|29.95|||Regression, Logistic|||||29.95|14.36|<0.0001
71660177|NCT04156620|142834754|SUPERIORITY||LS mean change|-0.94|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|-1.33|-0.56|||Mixed Models Analysis|||Week 16||-0.56|-1.33|<0.0001
71660178|NCT04156620|142834755|SUPERIORITY||LS mean change|3.01|STANDARD_ERROR_OF_MEAN|0.615|<|0.0001|TWO_SIDED|95.0|1.8|4.22|||Mixed Models Analysis|||Week 16||4.22|1.80|<0.0001
71773579|NCT05063318|143047359|SUPERIORITY||Least-squares geometric mean ratio|236.73|||||TWO_SIDED|90.0|177.35|316.0|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||316.00|177.35|
71773580|NCT05063318|143047360|SUPERIORITY||least-squares geometric mean ratio.|115.51|||||TWO_SIDED|90.0|100.07|133.33|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||133.33|100.07|
71773581|NCT05063318|143047361|SUPERIORITY||Least-squares geometric mean ratio.|217.57|||||TWO_SIDED|90.0|151.81|311.82|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence (TR or RT) as fixed effects, and patient (sequence) as a random effect.||||311.82|151.81|
71773582|NCT05063318|143047362|SUPERIORITY||Least-squares geometric mean ratio|36.67|||||TWO_SIDED|90.0|28.66|46.9|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||46.9|28.66|
71660179|NCT04156620|142834756|SUPERIORITY||LS mean change|-1.77|STANDARD_ERROR_OF_MEAN|0.373|<|0.0001|TWO_SIDED|95.0|-2.51|-1.04|||Mixed Models Analysis|||Week 16||-1.04|-2.51|<0.0001
71660180|NCT04156620|142834757|SUPERIORITY||Relative LS mean change|0.44|||<|0.0001|TWO_SIDED|95.0|0.37|0.51|||Mixed Models Analysis|||Week 16||0.51|0.37|<0.0001
71660181|NCT04156620|142834758|SUPERIORITY||Marginal difference|23.41|||<|0.0001|TWO_SIDED|95.0|15.61|31.66|||Regression, Logistic|||||31.66|15.61|<0.0001
71660182|NCT04156620|142834759|SUPERIORITY||Marginal difference|12.58|||<|0.0001|TWO_SIDED|95.0|7.96|17.19|||Regression, Logistic|||Week 16||17.19|7.96|<0.0001
71660183|NCT04156620|142834760|SUPERIORITY||Marginal difference|10.56|||<|0.0001|TWO_SIDED|95.0|5.64|15.47|||Regression, Logistic|||||15.47|5.64|<0.0001
71773583|NCT05063318|143047363|SUPERIORITY||Least-squares geometric mean ratio|99.89|||||TWO_SIDED|90.0|65.76|151.74|||ANOVA|ANOVA mixed-effects model included treatment, period and sequence as fixed effects, and patient (sequence) as a random effect||||151.74|65.76|
71773584|NCT00729924|143047366|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The hypothesis was that the ratio of the 4-hour CSF concentration value to the partial plasma area-under-the-curve 0-4h value would differ between participants with ABCB1 C/C and T/T genotypes.||||0.43
71773585|NCT00729924|143047367|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||We explored post-hoc whether the ratio of the 4-hour CSF concentration value to the 2-hour plasma concentration differs between participants with ABCB1 C/C and T/T genotypes.||||0.43
71773586|NCT01659658|143047377|SUPERIORITY||Odds Ratio (OR)|1.1|||=|0.7623|TWO_SIDED|95.0|0.6|2.01||P-value was calculated from the unstratified Cochran-Mantel-Haenszel (CMH) test to compare hematologic response rate between the treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% confidence interval (CI) for the odds ratio was based on the Wald approximation.|Statistical analysis was planned to be collected and analyzed in a combined manner for the non-ixazomib arm groups versus ixazomib group in this outcome measure.||2.01|0.60|=0.7623
71773587|NCT01659658|143047378|SUPERIORITY||Odds Ratio (OR)|0.75|||=|0.351|TWO_SIDED|95.0|0.41|1.38||P-value was calculated from the unstratified CMH test to make comparisons between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was derived from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||1.38|0.41|=0.3510
71773588|NCT01659658|143047380|SUPERIORITY||Hazard Ratio (HR)|0.82|||=|0.389|TWO_SIDED|95.0|0.52|1.29||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.29|0.52|=0.389
71773589|NCT01659658|143047381|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.135|TWO_SIDED|95.0|0.52|1.09||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.09|0.52|=0.135
71773590|NCT01659658|143047382|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2421|TWO_SIDED|95.0|0.48|1.21||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|1.21|0.48|0.2421
71773591|NCT01659658|143047383|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.036|TWO_SIDED|95.0|0.39|0.97||P-value was calculated using log-rank test stratified by the stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.97|0.39|=0.036
71735395|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.26||||0.9907|TWO_SIDED|95.0|1.042|1.526|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours||1.526|1.042|0.9907
71735396|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.27||||0.9973|TWO_SIDED|95.0|1.005|1.606|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours||1.606|1.005|0.9973
71832539|NCT01780298|143169189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.875|||<|0.0001|TWO_SIDED|95.0|0.609|1.141|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.141|0.609|<0.0001
71735397|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.61||||0.9954|TWO_SIDED|95.0|1.13|2.331|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours||2.331|1.130|0.9954
71735398|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.65||||0.983|TWO_SIDED|95.0|1.045|2.588|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours||2.588|1.045|0.9830
71660184|NCT04156620|142834761|SUPERIORITY||LS mean change|-0.66|STANDARD_ERROR_OF_MEAN|0.292||0.0234|TWO_SIDED|95.0|-1.24|-0.09|||Regression, Logistic|||||-0.09|-1.24|0.0234
71832540|NCT01780298|143169189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.649|||<|0.0001|TWO_SIDED|95.0|0.386|0.912|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.912|0.386|<0.0001
71735399|NCT01597635|142985747|SUPERIORITY_OR_OTHER||Ratio of Active/Placebo|1.52||||0.9312|TWO_SIDED|95.0|0.867|2.737|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours||2.737|0.867|0.9312
71832541|NCT01780298|143169189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.069||||0.3985|TWO_SIDED|95.0|-0.093|0.231|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.231|-0.093|0.3985
71832542|NCT01780298|143169189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.0267|TWO_SIDED|95.0|0.026|0.414|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.414|0.026|0.0267
71832543|NCT01780298|143169189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.305||||0.0036|TWO_SIDED|95.0|0.104|0.506|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.506|0.104|0.0036
71832544|NCT01780298|143169190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.564|||<|0.0001|TWO_SIDED|95.0|1.179|1.949|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||1.949|1.179|<0.0001
71735400|NCT01963845|142985779|SUPERIORITY_OR_OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
71735401|NCT01963845|142985780|SUPERIORITY_OR_OTHER|||||||0.7583|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in AST values from baseline to 24 weeks between the two groups.||||0.7583
71735402|NCT01963845|142985781|SUPERIORITY_OR_OTHER|||||||0.8569|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in ALT values from baseline to 24 weeks between the two groups.||||0.8569
71735403|NCT01963845|142985782|SUPERIORITY_OR_OTHER|||||||0.7984|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in LDL values from baseline to 24 weeks between the two groups.||||0.7984
71735404|NCT01963845|142985783|SUPERIORITY_OR_OTHER|||||||0.556|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.||||0.5560
71735405|NCT00767806|142985784|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.||||0.001
71735406|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.002|TWO_SIDED|95.0|-1.12|-0.25||P-value is for BPI severity of worst pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.||-0.25|-1.12|0.002
71735407|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.006|TWO_SIDED|95.0|-0.85|-0.14||P-value is for BPI severity of least pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.||-0.14|-0.85|0.006
71773592|NCT01659658|143047384|SUPERIORITY||Odds Ratio (OR)|1.69|||=|0.226|TWO_SIDED|95.0|0.72|3.99||P-value was calculated from the unstratified CMH test to compare vital organ response rate between the 2 treatment arms.|Cochran-Mantel-Haenszel||Odds ratio was calculated from a logistic regression model with treatment and 95% CI for the odds ratio was based on the Wald approximation.|||3.99|0.72|=0.2260
71773593|NCT01659658|143047385|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.163|TWO_SIDED|95.0|0.52|1.12||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|||1.12|0.52|=0.163
71773594|NCT01659658|143047388|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.025|TWO_SIDED|95.0|0.49|0.96||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.96|0.49|=0.025
71773595|NCT01659658|143047389|SUPERIORITY||Hazard Ratio (HR)|0.58|||=|0.01|TWO_SIDED|95.0|0.38|0.88||P-value was calculated using stratified log-rank test with stratification factors.|Log Rank||||Unadjusted stratified Cox regression model was used to estimate the hazard ratio and its 95% CIs for the treatment effect using the stratification factors.|0.88|0.38|=0.010
71773596|NCT01083485|143047423|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||A P value was not part of the analysis plan. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin was -1.0 meaning that OXN PR can be one unit inferior to OXY PR and still be considered non-inferior.|ANCOVA|The primary efficacy endpoint was analysed on the PP data using a mixed-model repeat measure analysis of covariance RMANCOVA.||The sample size was calculated for a significance level of 2.5% (1 sided) with 90% power. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin of 1.0 were assumed.||0.3|-0.5|
71735408|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||<|0.001|TWO_SIDED|95.0|-1.25|-0.46||P-value is for BPI severity of pain right now - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.||-0.46|-1.25|<0.001
71735409|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|||<|0.001|TWO_SIDED|95.0|-1.16|-0.35||P-value is for BPI interference with general activity - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.||-0.35|-1.16|<0.001
71735410|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.09|-0.34||P-value is for BPI interference with mood score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.||-0.34|-1.09|<0.001
71735411|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.02|TWO_SIDED|95.0|-0.84|-0.07||P-value is for BPI interference with walking ability - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.||-0.07|-0.84|0.020
71735412|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.012|TWO_SIDED|95.0|-0.9|-0.11||P-value is for BPI interference with normal work - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.||-0.11|-0.90|0.012
71735413|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.001|TWO_SIDED|95.0|-0.92|-0.22||P-value is for BPI interference with relations to others - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.||-0.22|-0.92|0.001
71735414|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.002|TWO_SIDED|95.0|-1.13|-0.27||P-value is for BPI interference with sleep score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.||-0.27|-1.13|0.002
71735415|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.005|TWO_SIDED|95.0|-0.96|-0.18||P-value is for BPI interference with enjoyment of life score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.||-0.18|-0.96|0.005
71735416|NCT00767806|142985785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.92|-0.25||P-value is for BPI average interference score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.||-0.25|-0.92|<0.001
71735417|NCT00767806|142985786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.05|-0.35||p-value is for weekly 24-hour average pain rating score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.||-0.35|-1.05|<0.001
71832545|NCT01780298|143169190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.291|||<|0.0001|TWO_SIDED|95.0|0.924|1.658|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||1.658|0.924|<0.0001
71773597|NCT04233034|143047425|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.89|TWO_SIDED|95.0|-0.11|0.1|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.10|-0.11|0.89
71832546|NCT01780298|143169190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.073|||<|0.0001|TWO_SIDED|95.0|0.724|1.421|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||1.421|0.724|<0.0001
71773598|NCT04233034|143047425|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.04|TWO_SIDED|95.0|0.01|0.27|||Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.27|0.01|0.04
71773599|NCT04233034|143047426|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8|TWO_SIDED|95.0|-0.1|0.08||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.08|-0.10|0.80
71773600|NCT04233034|143047426|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.8|TWO_SIDED|95.0|-0.08|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.13|-0.08|0.80
71773601|NCT04233034|143047426|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8|TWO_SIDED|95.0|-0.13|0.09||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.|Mean difference (HCL - Non-HCL) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.09|-0.13|0.80
71773602|NCT04233034|143047426|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|95.0|-0.09|0.13||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 13 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.13|-0.09|0.69
71832547|NCT01780298|143169190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.276||||0.0282|TWO_SIDED|95.0|0.031|0.521|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.521|0.031|0.0282
71735418|NCT00767806|142985786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||p-value is for weekly 24-hour worst pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.||-0.33|-1.08|<0.001
71735419|NCT00767806|142985786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.004|TWO_SIDED|95.0|-0.87|-0.17||p-value is for weekly 24-hour night pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.||-0.17|-0.87|0.004
71832548|NCT01780298|143169190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.207||||0.1223|TWO_SIDED|95.0|-0.057|0.471|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.471|-0.057|0.1223
71735420|NCT00767806|142985787|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||p-value is for number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.108
71735421|NCT00767806|142985788|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.||||0.006
71773603|NCT04233034|143047426|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.08|TWO_SIDED|95.0|-0.02|0.25||P-value was adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 26 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.25|-0.02|0.08
71832549|NCT01780298|143169190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.492|||<|0.0001|TWO_SIDED|95.0|0.273|0.71|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.710|0.273|<0.0001
71832550|NCT01780298|143169191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.372|||<|0.0001|TWO_SIDED|95.0|0.269|0.478|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 4 (Never smokers)|||0.478|0.269|<0.0001
71832551|NCT01780298|143169191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.256|||<|0.0001|TWO_SIDED|95.0|0.158|0.354|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 3 (Ex-smokers)|||0.354|0.158|<0.0001
71735422|NCT00767806|142985789|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is difference between duloxetine and placebo in number of patients who achieve criteria described in null hypothesis|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a \>=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a \>=20% reduction of BPI average pain rating from baseline at every visit.||||0.082
71735423|NCT00767806|142985790|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo groups in the empirical overall cumulated distribution of the percentage pain reduction|Kolnogorov-Smirnov test|||Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.||||0.013
71735424|NCT00767806|142985791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.077|TWO_SIDED|95.0|-0.33|0.02||p-value is for difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.||0.02|-0.33|0.077
71735425|NCT00767806|142985792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.011|TWO_SIDED|95.0|-0.56|-0.07||p-value is for difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value|ANCOVA|Main Effect Model: PGI-I=Treatment+Investigator+Baseline(Type III sums of squares). PGI-Severity score from baseline visit was used as the baseline.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.||-0.07|-0.56|0.011
71735426|NCT00767806|142985793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.255|TWO_SIDED|95.0|-1.28|0.34||p-value is for difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.||0.34|-1.28|0.255
71735427|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.||-0.37|-1.38|<0.001
71735428|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.133|TWO_SIDED|95.0|-0.9|0.12||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.||0.12|-0.90|0.133
71735429|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|||<|0.001|TWO_SIDED|95.0|-1.46|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.||-0.37|-1.46|<0.001
71773604|NCT04233034|143047426|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.08|TWO_SIDED|95.0|-0.01|0.28||P-value adjusted for multiplicity using the Benjamini-Hochberg procedure.|Mixed Models Analysis|The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.|Mean difference (Verapamil - Placebo) at 39 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.28|-0.01|0.08
71773605|NCT04233034|143047429|SUPERIORITY||Mean Difference (Final Values)|-25.0|||<|0.001|TWO_SIDED|95.0|-37.0|-14.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-14|-37|<0.001
71773606|NCT04233034|143047429|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.74|TWO_SIDED|95.0|-25.0|16.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||16|-25|0.74
71773607|NCT04233034|143047430|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
71773608|NCT04233034|143047430|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.74|TWO_SIDED|95.0|-9.0|13.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||13|-9|0.74
71773609|NCT04233034|143047431|SUPERIORITY||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|10.0|22.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||22|10|<0.001
71832552|NCT01780298|143169191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136||||0.0199|TWO_SIDED|95.0|0.022|0.249|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 1 (COPD) - Group 2 (Current cigarette smokers)|||0.249|0.022|0.0199
71832553|NCT01780298|143169191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.117||||0.0247|TWO_SIDED|95.0|0.015|0.218|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 3 (Ex-smokers) - Group 4 (Never smokers)|||0.218|0.015|0.0247
71832554|NCT01780298|143169191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.0204|TWO_SIDED|95.0|0.019|0.221|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 3 (Ex-smokers)|||0.221|0.019|0.0204
71832555|NCT01780298|143169191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.237|||<|0.0001|TWO_SIDED|95.0|0.127|0.347|||t-test, 2 sided|Pairwise comparisons obtained by 2-sided paired t-test (COPD subjects are paired to the non-COPD subjects by gender, age and ethnicity).|Difference Group 2 (Current cigarette smokers) - Group 4 (Never smokers)|||0.347|0.127|<0.0001
71832556|NCT01534494|143169227|OTHER|Paired t-test||||||0.008|||||||t-test, 2 sided|Paired t-test for significance of change. t(8) = 3.477. P(2-sided) = 0.008||Single-group pre-post contrast||||0.008
71832557|NCT05489484|143169254|OTHER|Paired-sample t-test was used to assess the change in Constant-Murley Score from baseline to 3 months.|Mean Difference (Net)|10.03|STANDARD_ERROR_OF_MEAN|2.124||0.001|TWO_SIDED|95.0|3.63|16.0|||t-test, 2 sided||Mean change from baseline in CMS at 3 months. Higher scores represent better shoulder function. Positive difference indicates clinical improvement.|Statistical analysis was performed on 23 participants with valid Constant-Murley Score (CMS) data at both baseline and 3-month follow-up.||16.00|3.63|0.001
71832558|NCT00444600|143169266|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-55.0|||<|0.001|TWO_SIDED|95.0|-78.0|-32.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in central subfield thickness mean change from sham+prompt laser||-32|-78|<0.001
71832559|NCT00444600|143169266|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-49.0|||<|0.001|TWO_SIDED|95.0|-72.0|-26.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-26|-72|<0.001
71832560|NCT00444600|143169266|SUPERIORITY_OR_OTHER_LEGACY||Difference in mean change|-52.0|||<|0.001|TWO_SIDED|95.0|-75.0|-29.0||Confidence interval is adjusted for multiple comparisons|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser||-29|-75|<0.001
71832561|NCT00444600|143169268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.2|8.5||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.5|3.2|<0.001
71832562|NCT00444600|143169268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|3.4|8.6||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||8.6|3.4|<0.001
71832563|NCT00444600|143169268|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.31|TWO_SIDED|95.0|-1.5|3.7||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.||||3.7|-1.5|0.31
71832564|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|23.0|||||TWO_SIDED|95.0|13.0|34.0||Confidence intervals are adjusted for multiple comparisons.|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year||34|13|
71832565|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|19.0|||||TWO_SIDED|95.0|9.0|29.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||29|9|
71832566|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-4.0|16.0||Confidence intervals adjusted for multiple comparisons|Binomial regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year||16|-4|
71773610|NCT04233034|143047431|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.95|TWO_SIDED|95.0|-8.0|14.0|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||14|-8|0.95
71773611|NCT04233034|143047432|SUPERIORITY||Risk Difference (RD)|0.38|||<|0.001|TWO_SIDED|95.0|0.21|0.53|||Regression, Logistic|||||0.53|0.21|<0.001
71773612|NCT04233034|143047432|SUPERIORITY||Risk Difference (RD)|0.03||||0.79|TWO_SIDED|95.0|-0.26|0.32|||Regression, Logistic|||||0.32|-0.26|0.79
71773613|NCT04233034|143047434|SUPERIORITY||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-22.0|-9.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-9|-22|<0.001
71773614|NCT04233034|143047434|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.74|TWO_SIDED|95.0|-13.0|9.0|||Mixed Models Analysis||Mean difference at 52 weeks (verapamil - placebo) adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||9|-13|0.74
71773615|NCT04233034|143047435|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.003|TWO_SIDED|95.0|-7.0|-1.0|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-1|-7|0.003
71773616|NCT04233034|143047435|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.74|TWO_SIDED|95.0|-6.0|4.0|||Mixed Models Analysis||Mean difference (verapamil - placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||4|-6|0.74
71773617|NCT04233034|143047436|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.17|-0.04|0.23
71773618|NCT04233034|143047436|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.79|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.79
71773619|NCT04233034|143047437|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.39|TWO_SIDED|95.0|-0.3|0.7|||Regression, Linear||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.7|-0.3|0.39
71832567|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.84|||<|0.001|TWO_SIDED|95.0|1.4|2.42||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.42|1.40|<0.001
71832568|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.68|||<|0.001|TWO_SIDED|95.0|1.27|2.21||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||2.21|1.27|<0.001
71773620|NCT04233034|143047437|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.74|TWO_SIDED|95.0|-1.0|0.6|||Regression, Linear||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.6|-1.0|0.74
71773621|NCT04233034|143047439|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||-0.3|-1.1|<0.001
71773622|NCT04233034|143047439|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.65|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.4|-1.0|0.65
71773623|NCT04233034|143047442|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.07|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis||Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.|||0.20|-0.01|0.07
71832569|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.21||||0.16|TWO_SIDED|95.0|0.88|1.66||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.|Eyes were analyzed.|Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year||1.66|0.88|0.16
71832570|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-5.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-5|-16|
71773624|NCT04233034|143047442|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.52|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis||Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.|||0.05|-0.30|0.52
71773625|NCT02791399|143047453|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.12|||<|0.05|TWO_SIDED|95.0|-2.45|0.2|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.20|-2.45|<0.05
71773626|NCT02791399|143047454|EQUIVALENCE|Our analysis examined the estimated probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-0.04|||<|0.05|TWO_SIDED|95.0|-0.15|0.06|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||0.06|-0.15|<0.05
71773627|NCT02791399|143047455|NON_INFERIORITY|Pain intensity and pain-related function were tested in non-inferiority analyses, as we hypothesized that the ISOT intervention would not negatively impact pain or function. One-half SD difference in change was considered the appropriate non-inferiority limit.|Non-inferiority analysis|1.6|||||TWO_SIDED|||||||||||||
71773628|NCT02791399|143047456|EQUIVALENCE|This analysis is comparing estimated averages and probabilities for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|-1.99|||<|0.05|TWO_SIDED|95.0|-5.83|1.85|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||1.85|-5.83|<0.05
71773629|NCT02791399|143047457|EQUIVALENCE|Our analysis examined the estimated averages for each group at each time point after accounting for covariates.|Mean Difference (Final Values)|1.03|||<|0.05|TWO_SIDED|95.0|-6.73|8.8|||Mixed Models Analysis|Models controlled for age, gender, depression severity, pain intensity, clinician type, and proportion of clinician panel prescribed opioids.||||8.80|-6.73|<0.05
71773630|NCT01865084|143047484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.307||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.307
71773631|NCT01865084|143047484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.538||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis|||||||0.538
71773632|NCT03607422|143047492|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|59.6|||<|0.001|TWO_SIDED|95.0|53.1|66.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||66.2|53.1|<0.001
71773633|NCT03607422|143047492|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|46.9|||<|0.001|TWO_SIDED|95.0|39.9|53.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.9|39.9|<0.001
71773634|NCT03607422|143047493|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.4|||<|0.001|TWO_SIDED|95.0|41.0|53.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||53.7|41.0|<0.001
71773635|NCT03607422|143047493|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|34.0|||<|0.001|TWO_SIDED|95.0|27.8|40.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||40.2|27.8|<0.001
71773636|NCT03607422|143047494|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.4|||<|0.001|TWO_SIDED|95.0|43.8|57.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.1|43.8|<0.001
71832571|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-10.0|||||TWO_SIDED|95.0|-16.0|-4.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||-4|-16|
71660185|NCT04135196|142834762|OTHER|||||||0.119|||||||Regression, Linear|||"The power analysis for the overall study was based on 12-month change in UD iBMC. The power calculation, based on pilot data, determined that 20 participants per group would have 80% power to detect a 1.0±1.1% change.~The null hypothesis was that change in UD iBMC was not proportional to strain magnitude. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group."|"Overall model fit: R\^2=0.101, F=2.244, df1=2, df2=40, p=0.119~Contrast between the low strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.007, Beta=0.374, t=2.114, p=0.041, 95% CI of B: \[0.001, 0.030\]~Contrast between the high strain magnitude group and the control group: B=0.009, Std. Error of estimate of B=0.007, Beta=0.221, t=1.247, p=0.220, 95% CI of B: \[-0.005, 0.022\]"|||0.119
71735430|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||0.003|TWO_SIDED|95.0|0.38|1.88||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.||1.88|0.38|0.003
71832572|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|1.0|||||TWO_SIDED|95.0|-7.0|9.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year||9|-7|
71735431|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.469|TWO_SIDED|95.0|-0.93|0.43||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.||0.43|-0.93|0.469
71735432|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.006|TWO_SIDED|95.0|-0.98|-0.17||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.||-0.17|-0.98|0.006
71832573|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24|||<|0.001|TWO_SIDED|95.0|0.09|0.65||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.65|0.09|<0.001
71832574|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.24||||0.001|TWO_SIDED|95.0|0.08|0.68||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||0.68|0.08|0.001
71832575|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.08||||0.75|TWO_SIDED|95.0|0.62|1.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year||1.87|0.62|0.75
71832576|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|16.0|||||TWO_SIDED|95.0|6.0|26.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between to study eyes.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||26|6|
71832577|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|13.0|||||TWO_SIDED|95.0|4.0|22.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||22|4|
71889814|NCT01264939|143301213|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.67|||<|0.0001|TWO_SIDED|95.0|-6.28|-3.06||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.06|-6.28|<0.0001
71889815|NCT01264939|143301214|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||0.0006
71889816|NCT01264939|143301215|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71889817|NCT00584870|143301311|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.39||0.001|TWO_SIDED|80.0|-1.67|-0.67||p-value was based on repeated measures model from pairwise comparisons, and statistical test was 1-sided with 0.1 significance level.|Repeated Measures Model|||LS mean difference was estimated from the repeated measures model with baseline, center, treatment, week and treatment-by-week interaction as fixed main effects and participant as random effect.||-0.67|-1.67|0.001
71735433|NCT00767806|142985794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.001|TWO_SIDED|95.0|-6.41|-1.6||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.||-1.60|-6.41|0.001
71832578|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|6.0|||||TWO_SIDED|95.0|-2.0|15.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year||15|-2|
71832579|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.09|||<|0.001|TWO_SIDED|95.0|1.35|3.22|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||3.22|1.35|<0.001
71889818|NCT01957137|143301419|SUPERIORITY_OR_OTHER|||||||0.3773|||||||Mixed Models Analysis|The final model included cycling, period and the interaction between cycling and period.||||||0.3773
71889819|NCT01957137|143301420|SUPERIORITY_OR_OTHER|||||||0.2396|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.2396
71889820|NCT01957137|143301421|SUPERIORITY_OR_OTHER|||||||0.8874|||||||Mixed Models Analysis|The final model included cycling and period.||||||0.8874
71889821|NCT02116621|143301455|SUPERIORITY||Adjusted difference in differences|-1.36|||||TWO_SIDED|95.0|-2.91|0.19|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.19|-2.91|
71889822|NCT02116621|143301456|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)|||0.21
71889823|NCT02116621|143301457|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)|||0.06
71889824|NCT02116621|143301458|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)|||0.35
71889825|NCT02116621|143301459|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)|||0.86
71889826|NCT02116621|143301460|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).|||0.70
71889827|NCT02116621|143301461|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).|||0.20
71889828|NCT02116621|143301462|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).|||0.66
71889829|NCT02116621|143301463|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).|||0.44
71889830|NCT02116621|143301464|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).|||0.58
71889831|NCT02116621|143301465|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).|||0.73
71889832|NCT02116621|143301466|SUPERIORITY||Adjusted difference in differences|-1.41|||||TWO_SIDED|95.0|-2.87|0.06|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|||0.06|-2.87|
71889833|NCT02116621|143301467|SUPERIORITY||Adjusted difference in differences|0.93|||||TWO_SIDED|95.0|-0.92|2.79|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|2.79|-0.92|
71889834|NCT02116621|143301468|SUPERIORITY||Adjusted difference in differences|-0.17|||||TWO_SIDED|95.0|-1.45|1.12|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|1.12|-1.45|
71889835|NCT02116621|143301469|SUPERIORITY||Adjusted difference in differences|1.9|||||TWO_SIDED|95.0|-1.66|5.47|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|5.47|-1.66|
71889836|NCT02116621|143301470|SUPERIORITY||Adjusted difference in differences|4.64|||||TWO_SIDED|95.0|-2.25|11.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|11.54|-2.25|
71889837|NCT02116621|143301471|SUPERIORITY||Adjusted difference in differences|2.55|||||TWO_SIDED|95.0|-1.5|6.6|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|6.60|-1.50|
71889838|NCT02116621|143301472|SUPERIORITY||Adjusted difference in differences|7.29|||||TWO_SIDED|95.0|-3.16|17.75|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|17.75|-3.16|
71889839|NCT02116621|143301473|SUPERIORITY||Adjusted difference in differences|3.31|||||TWO_SIDED|95.0|-1.57|8.19|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|8.19|-1.57|
71889840|NCT02116621|143301474|SUPERIORITY||Adjusted difference in differences|-1.57|||||TWO_SIDED|95.0|-7.68|4.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.|4.54|-7.68|
71773637|NCT03607422|143047494|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|32.6|||<|0.001|TWO_SIDED|95.0|25.8|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.4|25.8|<0.001
71773638|NCT03607422|143047495|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|46.7|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.4|46.7|<0.001
71889841|NCT02116621|143301475|SUPERIORITY||Mean Difference (Final Values)|11.9||||0.01|TWO_SIDED|95.0|2.59|21.24|||Regression, Linear|||||21.24|2.59|0.01
71889842|NCT02116621|143301476|SUPERIORITY||Adjusted difference in differences|-0.79|||||TWO_SIDED|95.0|-2.37|0.8|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||0.80|-2.37|
71889843|NCT02116621|143301477|SUPERIORITY||Adjusted difference in differences|0.31|||||TWO_SIDED|95.0|-1.18|1.81|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.81|-1.18|
71889844|NCT02116621|143301478|SUPERIORITY||Adjusted difference in differences|0.3|||||TWO_SIDED|95.0|-1.01|1.61|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.61|-1.01|
71889845|NCT02116621|143301479|SUPERIORITY||Adjusted difference in differences|-0.66|||||TWO_SIDED|95.0|-2.55|1.24|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||1.24|-2.55|
71889846|NCT02116621|143301480|SUPERIORITY||Adjusted difference in differences|1.05|||||TWO_SIDED|95.0|-2.54|4.64|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||4.64|-2.54|
71889847|NCT02116621|143301481|SUPERIORITY||Adjusted difference in differences|4.24|||||TWO_SIDED|95.0|-2.73|11.2|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||11.20|-2.73|
71889848|NCT02116621|143301482|SUPERIORITY||Adjusted difference in differences|1.76|||||TWO_SIDED|95.0|-2.37|5.89|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||5.89|-2.37|
71889849|NCT02116621|143301483|SUPERIORITY||Adjusted difference in differences|7.77|||||TWO_SIDED|95.0|-2.87|18.42|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||18.42|-2.87|
71889850|NCT02116621|143301484|SUPERIORITY||Adjusted difference in differences|2.15|||||TWO_SIDED|95.0|-2.84|7.13|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||7.13|-2.84|
71889851|NCT02116621|143301485|SUPERIORITY||Adjusted difference in differences|1.81|||||TWO_SIDED|95.0|-4.41|8.02|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.|||8.02|-4.41|
71889852|NCT02116621|143301486|SUPERIORITY||Adjusted difference in differences|0.16|||||TWO_SIDED|95.0|-1.47|1.79|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.79|-1.47|
71889853|NCT02116621|143301487|SUPERIORITY||Adjusted difference in differences|-1.24|||||TWO_SIDED|95.0|-2.77|0.3|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||0.30|-2.77|
71889854|NCT02116621|143301488|SUPERIORITY||Adjusted difference in differences|-0.26|||||TWO_SIDED|95.0|-1.61|1.09|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||1.09|-1.61|
71889855|NCT02116621|143301489|SUPERIORITY||Adjusted difference in differences|0.76|||||TWO_SIDED|95.0|-1.19|2.7|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||2.70|-1.19|
71889856|NCT02116621|143301490|SUPERIORITY||Adjusted difference in differences|0.08|||||TWO_SIDED|95.0|-3.61|3.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||3.77|-3.61|
71889857|NCT02116621|143301491|SUPERIORITY||Adjusted difference in differences|-1.91|||||TWO_SIDED|95.0|-9.07|5.26|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.26|-9.07|
71889858|NCT02116621|143301492|SUPERIORITY||Adjusted difference in differences|1.53|||||TWO_SIDED|95.0|-2.7|5.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||5.77|-2.70|
71889859|NCT02116621|143301493|SUPERIORITY||Adjusted difference in differences|4.13|||||TWO_SIDED|95.0|-6.81|15.07|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||15.07|-6.81|
71889860|NCT02116621|143301494|SUPERIORITY||Adjusted difference in differences|1.0|||||TWO_SIDED|95.0|-4.11|6.11|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||6.11|-4.11|
71889861|NCT02116621|143301495|SUPERIORITY||Adjusted difference in differences|1.11|||||TWO_SIDED|95.0|-5.27|7.48|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.|||7.48|-5.27|
71889862|NCT02116621|143301496|SUPERIORITY||Mean Difference (Final Values)|9.41||||0.054|TWO_SIDED|95.0|-0.15|18.96|||Regression, Linear|||||18.96|-0.15|0.054
71889863|NCT02764541|143301517|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive ductal carcinoma||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||||||0.0045
71660186|NCT04135196|142834762|OTHER||||||<|0.01|||||||Regression, Linear|||The null hypothesis was that change in UD iBMC was not proportional to strain rate. Raw change in iBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.438, F=12.836, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.009, Beta=0.599, t=4.050, p=\<0.001, 95% CI of B: \[0.018, 0.055\]~Contrast between the high strain rate group and the control group: B=0.041, Std. Error of estimate of B=0.009, Beta=0.678, t=4.589, p=\<0.001, 95% CI of B: \[0.023, 0.060\]"|||<0.01
71735434|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.168|TWO_SIDED|95.0|-0.53|3.02||p-value is for difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.||3.02|-0.53|0.168
71735435|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.01|TWO_SIDED|95.0|0.53|3.96||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.||3.96|0.53|0.010
71735436|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.58||||0.016|TWO_SIDED|95.0|0.86|8.3||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.||8.30|0.86|0.016
71735437|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.88|||<|0.001|TWO_SIDED|95.0|2.15|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.||7.61|2.15|<0.001
71735438|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.58||||0.101|TWO_SIDED|95.0|-0.5|5.67||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.||5.67|-0.50|0.101
71735439|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.058|TWO_SIDED|95.0|-0.12|7.12||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.||7.12|-0.12|0.058
71735440|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43||||0.227|TWO_SIDED|95.0|-1.52|6.37||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.||6.37|-1.52|0.227
71735441|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91||||0.383|TWO_SIDED|95.0|-2.39|6.21||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.||6.21|-2.39|0.383
71735442|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.03|TWO_SIDED|95.0|0.38|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.||7.61|0.38|0.030
71735443|NCT00767806|142985795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.022|TWO_SIDED|95.0|0.59|7.6||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.||7.60|0.59|0.022
71735444|NCT00767806|142985796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.12||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.||0.12|0.03|<0.001
71832580|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.89|||<|0.001|TWO_SIDED|95.0|1.25|2.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.87|1.25|<0.001
71735445|NCT00767806|142985796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.002|TWO_SIDED|95.0|0.02|0.08||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.||0.08|0.02|0.002
71773639|NCT03607422|143047495|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.9|||<|0.001|TWO_SIDED|95.0|30.6|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|30.6|<0.001
71773640|NCT03607422|143047496|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.0|||<|0.001|TWO_SIDED|95.0|50.9|63.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.0|50.9|<0.001
71773641|NCT03607422|143047496|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|38.9|51.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||51.4|38.9|<0.001
71773642|NCT03607422|143047497|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.4|||<|0.001|TWO_SIDED|95.0|34.2|46.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.5|34.2|<0.001
71773643|NCT03607422|143047497|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.4|||<|0.001|TWO_SIDED|95.0|23.5|35.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||35.3|23.5|<0.001
71773644|NCT03607422|143047498|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|10.6|19.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||19.3|10.6|<0.001
71773645|NCT03607422|143047498|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|6.7|||<|0.001|TWO_SIDED|95.0|3.4|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.0|3.4|<0.001
71773646|NCT03607422|143047499|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|7.2|||<|0.001|TWO_SIDED|95.0|3.8|10.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||10.5|3.8|<0.001
71773647|NCT03607422|143047500|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|8.6|||<|0.001|TWO_SIDED|95.0|4.3|12.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||12.9|4.3|<0.001
71773648|NCT03607422|143047501|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-23.1|||<|0.001|TWO_SIDED|95.0|-28.4|-17.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-17.8|-28.4|<0.001
71773649|NCT03607422|143047501|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|-22.4|||<|0.001|TWO_SIDED|95.0|-27.8|-16.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||-16.9|-27.8|<0.001
71889864|NCT02764541|143301517|EQUIVALENCE|The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive lobular carcinoma||||||0.0161|||||||Wilcoxon (Mann-Whitney)|||||||0.0161
71735446|NCT00767806|142985797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.461|TWO_SIDED|95.0|-0.03|0.06||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.||0.06|-0.03|0.461
71735447|NCT00767806|142985797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.374|TWO_SIDED|95.0|-0.09|0.03||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.||0.03|-0.09|0.374
71735448|NCT00767806|142985797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.557|TWO_SIDED|95.0|-0.09|0.05||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.||0.05|-0.09|0.557
71773650|NCT03607422|143047502|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.8|||<|0.001|TWO_SIDED|95.0|42.2|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|42.2|<0.001
71832581|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.43||||0.07|TWO_SIDED|95.0|0.9|2.29||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year||2.29|0.90|0.07
71735449|NCT00767806|142985797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.007|TWO_SIDED|95.0|-0.1|-0.02||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.||-0.02|-0.10|0.007
71735450|NCT00767806|142985799|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for difference between placebo and duloxetine groups in uric acid - change|ANOVA|Change Variable = Treatment + Investigator (Type III sums of squares). Rank-transformed change was used as change variable in the ANOVA model.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.||||0.010
71660187|NCT04135196|142834763|OTHER|||||||0.809|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain magnitude. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.011, F=0.213, df1=2, df2=40, p=0.809~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.006, Beta=0.039, t=0.209, p=0.836, 95% CI of B: \[-0.012, 0.014\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.006, Beta=-0.077, t=-0.412, p=0.682, 95% CI of B: \[-0.015, 0.010\]"|||0.809
71773651|NCT03607422|143047502|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|30.1|45.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.8|30.1|<0.001
71889865|NCT02764541|143301518|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D||||||0.9288|||||||Wilcoxon (Mann-Whitney)|||||||0.9288
71735451|NCT00767806|142985800|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value is for difference between duloxetine and placebo in albumin - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.||||0.031
71889866|NCT02764541|143301520|EQUIVALENCE|The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D|Mean Difference (Final Values)|0.02||||0.92|TWO_SIDED|95.0|-0.29|0.32|||Regression, Linear|||||0.32|-0.29|0.920
71889867|NCT02764541|143301521|EQUIVALENCE|The hypothesis is that there is no difference of RCB response rate between Arm C and Arm D||||||0.758|||||||Fisher Exact|||||||0.758
71889868|NCT00749190|143301523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.1||0.0226|TWO_SIDED|95.0|-0.44|-0.03||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 1 mg minus placebo|||-0.03|-0.44|0.0226
71889869|NCT00749190|143301523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.59|-0.18||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 5 mg minus placebo|||-0.18|-0.59|0.0002
71889870|NCT00749190|143301523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.51||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 10 mg minus placebo|||-0.51|-0.91|<0.0001
71889871|NCT00749190|143301523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.5||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 25 mg minus placebo|||-0.50|-0.91|<0.0001
71889872|NCT00749190|143301523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.84|-0.43||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 50 mg minus placebo|||-0.43|-0.84|<0.0001
71889873|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|83.8|||<|0.001|ONE_SIDED|97.5|61.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||61.0|<0.001
71889874|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|88.2|||<|0.001|ONE_SIDED|97.5|67.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||67.4|<0.001
71773652|NCT03607422|143047503|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|51.8|||<|0.001|TWO_SIDED|95.0|44.4|59.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||59.1|44.4|<0.001
71773653|NCT03607422|143047503|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|35.9|||<|0.001|TWO_SIDED|95.0|28.2|43.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.5|28.2|<0.001
71773654|NCT03607422|143047504|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|53.3|||<|0.001|TWO_SIDED|95.0|46.0|60.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||60.6|46.0|<0.001
71773655|NCT03607422|143047504|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.7|48.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.0|32.7|<0.001
71773656|NCT03607422|143047505|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|54.8|||<|0.001|TWO_SIDED|95.0|47.2|62.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||62.3|47.2|<0.001
71773657|NCT03607422|143047505|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|40.3|||<|0.001|TWO_SIDED|95.0|32.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||48.3|32.3|<0.001
71773658|NCT03607422|143047506|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|42.8|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||58.5|42.8|<0.001
71773659|NCT03607422|143047506|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.9|||<|0.001|TWO_SIDED|95.0|29.5|46.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||46.3|29.5|<0.001
71773660|NCT03607422|143047507|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|18.1|||<|0.0001|TWO_SIDED|95.0|13.5|22.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||22.7|13.5|<0.0001
71773661|NCT03607422|143047507|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|13.4|||<|0.001|TWO_SIDED|95.0|9.2|17.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||17.6|9.2|<0.001
71773662|NCT03607422|143047508|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-49.45|STANDARD_ERROR_OF_MEAN|3.364|<|0.001|TWO_SIDED|95.0|-56.05|-42.84|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-42.84|-56.05|<0.001
71773663|NCT03607422|143047508|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-34.16|STANDARD_ERROR_OF_MEAN|3.386|<|0.001|TWO_SIDED|95.0|-40.81|-27.51|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-27.51|-40.81|<0.001
71773664|NCT03607422|143047509|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-50.14|STANDARD_ERROR_OF_MEAN|3.127|<|0.001|TWO_SIDED|95.0|-56.28|-44.0|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-44.00|-56.28|<0.001
71773665|NCT03607422|143047509|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-39.62|STANDARD_ERROR_OF_MEAN|3.139|<|0.001|TWO_SIDED|95.0|-45.79|-33.46|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.46|-45.79|<0.001
71773666|NCT03607422|143047510|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|54.7|||<|0.001|TWO_SIDED|95.0|47.7|61.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||61.7|47.7|<0.001
71832582|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-11.0|-2.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-2|-11|
71832583|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|-6.0|||||TWO_SIDED|95.0|-10.0|-1.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||-1|-10|
71832584|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.0|||||TWO_SIDED|95.0|-6.0|6.0||Confidence intervals are adjusted for multiple comparisons.|Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year||6|-6|
71773667|NCT03607422|143047510|SUPERIORITY||Adjusted Response Rate Difference|42.1|||<|0.001|TWO_SIDED|95.0|34.5|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||49.8|34.5|<0.001
71773668|NCT03607422|143047511|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|49.0|||<|0.001|TWO_SIDED|95.0|41.4|56.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.5|41.4|<0.001
71773669|NCT03607422|143047511|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|42.8||||0.002|TWO_SIDED|95.0|35.0|50.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.6|35.0|0.002
71773670|NCT03607422|143047512|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.949|<|0.001|TWO_SIDED|95.0|-45.8|-34.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-34.22|-45.80|<0.001
71773671|NCT03607422|143047512|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-29.47|STANDARD_ERROR_OF_MEAN|2.941|<|0.001|TWO_SIDED|95.0|-35.24|-23.69|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.||||-23.69|-35.24|<0.001
71773672|NCT03607422|143047513|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|44.5|||<|0.001|TWO_SIDED|95.0|35.0|54.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||54.1|35.0|<0.001
71773673|NCT03607422|143047513|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|34.4|||<|0.001|TWO_SIDED|95.0|24.7|44.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.2|24.7|<0.001
71832585|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.21||||0.009|TWO_SIDED|95.0|0.05|0.87|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.87|0.05|0.009
71735452|NCT00767806|142985801|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo in alkaline phosphatase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.||||0.004
71735453|NCT00767806|142985802|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for difference between duloxetine and placebo in alanine aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.||||0.013
71735454|NCT00767806|142985803|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||p-value for difference between duloxetine and placebo in aspartate aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.||||0.039
71735455|NCT00767806|142985804|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for difference between duloxetine and placebo in creatinine - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.||||0.024
71735456|NCT00767806|142985805|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for difference between duloxetine and placebo in total protein - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.||||0.019
71832586|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.28||||0.01|TWO_SIDED|95.0|0.08|0.97|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||0.97|0.08|0.01
71660188|NCT04135196|142834763|OTHER|||||||0.155|||||||Regression, Linear|||The null hypothesis was that change in UD cBMC was not proportional to strain rate. Raw change in cBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.107, F=1.971, df1=2, df2=33, p=0.155~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.008, Beta=0.284, t=1.526, p=0.137, 95% CI of B: \[-0.004, 0.027\]~Contrast between the high strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.008, Beta=0.342, t=1.837, p=0.075, 95% CI of B: \[-0.002, 0.030\]"|||0.155
71660189|NCT04135196|142834764|OTHER|||||||0.991|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain magnitude. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=\<0.001, F=0.009, df1=2, df2=40, p=0.991~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.009, Beta=0.025, t=0.133, p=0.894, 95% CI of B: \[-0.016, 0.018\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.008, Beta=0.012, t=0.063, p=0.950, 95% CI of B: \[-0.016, 0.017\]"|||0.991
71660190|NCT04135196|142834764|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMC was not proportional to strain rate. Raw change in ecBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.216, F=4.548, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.455, t=2.607, p=0.014, 95% CI of B: \[0.006, 0.052\]~Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.011, Beta=0.447, t=2.563, p=0.015, 95% CI of B: \[0.006, 0.052\]"|||0.018
71660191|NCT04135196|142834765|OTHER|||||||0.153|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain magnitude. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.090, F=1.968, df1=2, df2=40, p=0.153~Contrast between the low strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.003, Beta=0.352, t=1.973, p=0.055, 95% CI of B: \[0.000, 0.013\]~Contrast between the high strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.003, Beta=0.156, t=0.874, p=0.387, 95% CI of B: \[-0.004, 0.009\]"|||0.153
71660192|NCT04135196|142834765|OTHER|||||||0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMC was not proportional to strain rate. Raw change in tBMC was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.331, F=8.152, df1=2, df2=33, p=0.001~Contrast between the low strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.004, Beta=0.473, t=2.930, p=0.006, 95% CI of B: \[0.004, 0.020\]~Contrast between the high strain rate group and the control group: B=0.016, Std. Error of estimate of B=0.004, Beta=0.617, t=3.828, p=0.001, 95% CI of B: \[0.008, 0.025\]"|||0.001
71735457|NCT00767806|142985806|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||p-value is for difference between placebo and duloxetine groups in change of systolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.||||0.329
71735458|NCT00767806|142985806|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||p-value is for difference between placebo and duloxetine groups in change of diastolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.||||0.562
71735459|NCT00767806|142985808|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||p-value is for difference between duloxetine and placebo in pulse rate - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.||||0.680
71735460|NCT00858208|142985813|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED||||||paired t-test|||||||0.0072
71735461|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED||||||paired t-test|||Change from baseline at Week 6||||0.0433
71735462|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.0133|TWO_SIDED||||||paired t-test|||Change from baseline at Week 12||||0.0133
71832587|NCT00444600|143169269|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.02||||0.95|TWO_SIDED|95.0|0.47|2.2|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year||2.20|0.47|0.95
71832588|NCT00444600|143169270|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.0|||<|0.001|TWO_SIDED|95.0|1.52|2.64||Confidence intervals are adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.64|1.52|<0.001
71832589|NCT00444600|143169270|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.001|TWO_SIDED|95.0|1.13|2.13||Confidence intervals adjusted for multiple comparisons|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.13|1.13|0.001
71735463|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 18||||0.0278
71735464|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||paired t-test|||Change from baseline at Week 24||||0.0160
71735465|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||paired t-test|||Change from baseline at Week 30||||0.0264
71735466|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||paired t-test|||Change from baseline at Week 36||||0.0278
71735467|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.1854|TWO_SIDED||||||paired t-test|||Change from baseline at Week 42||||0.1854
71832590|NCT00444600|143169270|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.76|||<|0.001||95.0|1.31|2.36||Confidence intervals adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser||2.36|1.31|<0.001
71832591|NCT00444600|143169280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.08
71832592|NCT00444600|143169280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
71832593|NCT00444600|143169281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.03
71832594|NCT00444600|143169281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||GEE repeated measures|||P value for comparison with sham||||0.17
71832595|NCT00444600|143169285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.01|-0.44||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.44|-1.01|<0.001
71832596|NCT00444600|143169285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.68|||<|0.001|TWO_SIDED|95.0|-0.96|-0.41||Confidence intervals adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.41|-0.96|<0.001
71832597|NCT00444600|143169285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.91|-0.34||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser||-0.34|-0.91|<0.001
71832598|NCT05132478|143169287|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||||||0.720
71832599|NCT05132478|143169288|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
71832600|NCT05132478|143169289|SUPERIORITY|||||||0.228|||||||t-test, 2 sided|||baseline||||0.228
71889875|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.999
71735468|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.1684|TWO_SIDED||||||paired t-test|||Change from baseline at Week 48||||0.1684
71735469|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.4718|TWO_SIDED||||||paired t-test|||Change from baseline at Week 54||||0.4718
71735470|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||paired t-test|||Change from baseline at Week 60||||0.4340
71832601|NCT05132478|143169289|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||Post-Intervention||||0.176
71832602|NCT05132478|143169290|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||baseline||||0.410
71832603|NCT05132478|143169290|SUPERIORITY|||||||0.351|||||||ANOVA|||Post-Intervention||||0.351
71832604|NCT05132478|143169291|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
71735471|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.7765|TWO_SIDED||||||paired t-test|||Change from baseline at Week 66||||0.7765
71735472|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.7544|TWO_SIDED||||||paired t-test|||Change from baseline at Week 72||||0.7544
71735473|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.7201|TWO_SIDED||||||paired t-test|||Change from baseline at Week 84||||0.7201
71735474|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.5692|TWO_SIDED||||||paired t-test|||Change from baseline at Week 90||||0.5692
71832605|NCT05132478|143169292|SUPERIORITY||||||<|0.001||||||calculated p-value|t-test, 2 sided|||||||<0.001
71832606|NCT00106080|143169293|SUPERIORITY_OR_OTHER_LEGACY||Difference between groups after adjust|5.7||||0.03||||||No multiple comparisons, a priori threshold \< 0.05|GEE regression|Generalized estimating equations (GEE) regression, clustering for provider.||Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.||||0.03
71832607|NCT01852071|143169295|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
71832608|NCT01852071|143169295|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||||
71832609|NCT01852071|143169295|SUPERIORITY||Difference in percentages|7.69|||||TWO_SIDED|95.0|-10.08|25.13||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||25.13|-10.08|
71832610|NCT01852071|143169296|SUPERIORITY||Difference in percentages|35.71|||||TWO_SIDED|95.0|11.21|64.86||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||64.86|11.21|
71832611|NCT01852071|143169296|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||||
71832612|NCT01852071|143169296|SUPERIORITY||Difference in percentages|19.23|||||TWO_SIDED|95.0|0.71|39.35||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||39.35|0.71|
71660193|NCT04135196|142834766|OTHER|||||||0.84|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain magnitude. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.009, F=0.176, df1=2, df2=40, p=0.840~Contrast between the low strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.091, t=0.489, p=0.628, 95% CI of B: \[-0.002, 0.003\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.001, Beta=0.101, t=0.544, p=0.589, 95% CI of B: \[-0.002, 0.003\]"|||0.840
71735475|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 96||||0.2749
71735476|NCT00858208|142985814|SUPERIORITY_OR_OTHER|||||||0.2749|TWO_SIDED||||||paired t-test|||Change from baseline at Week 102||||0.2749
71735477|NCT00858208|142985816|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED||||||paired t-test|||Change at Month 6||||0.2970
71735478|NCT00858208|142985816|SUPERIORITY_OR_OTHER|||||||0.1392|TWO_SIDED||||||paired t-test|||Change at Month 12||||0.1392
71735479|NCT00858208|142985816|SUPERIORITY_OR_OTHER|||||||0.0573|TWO_SIDED||||||paired t-test|||Change at Month 18||||0.0573
71735480|NCT00858208|142985816|SUPERIORITY_OR_OTHER|||||||0.7625|TWO_SIDED||||||paired t-test|||Change at Month 24||||0.7625
71735481|NCT00858208|142985817|SUPERIORITY_OR_OTHER|||||||0.2759|TWO_SIDED||||||paired t-test|||||||0.2759
71735482|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||||TWO_SIDED|60.0|5.0|15.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||15|5|
71735483|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.0|||||TWO_SIDED|60.0|18.0|31.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||31|18|
71735484|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0|||||TWO_SIDED|60.0|25.0|39.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||39|25|
71735485|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|36.0|||||TWO_SIDED|60.0|29.0|43.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||43|29|
71735486|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||||TWO_SIDED|60.0|6.0|22.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||22|6|
71735487|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.0|||||TWO_SIDED|60.0|27.0|42.0|||||Superiority criterion versus placebo: Lower bound of 60% credible interval \>20%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||42|27|
71735488|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.0|||||TWO_SIDED|60.0|-32.0|-17.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-17|-32|
71735489|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|||||TWO_SIDED|60.0|-16.0|-4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||-4|-16|
71735490|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|60.0|-9.0|4.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||4|-9|
71735491|NCT01393639|142985827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|60.0|-5.0|8.0|||||Non inferiority criterion versus prednisone 10 mg: Lower bound of 60% credible interval \>-5%. Non-responder imputation was used to handle dropouts at Week 8.|Bayesian 4 Parameter Emax Model Based Estimates are provided.||8|-5|
71735492|NCT01393639|142985828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.64|||||TWO_SIDED|95.0|-13.75|17.03|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||17.03|-13.75|
71735493|NCT01393639|142985828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.71|||||TWO_SIDED|90.0|-22.16|8.75|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||8.75|-22.16|
71735494|NCT01393639|142985828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|90.0|-20.45|10.3|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||10.30|-20.45|
71832613|NCT01852071|143169297|SUPERIORITY||Difference in percentages|14.29|||||TWO_SIDED|95.0|-5.4|42.81||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||42.81|-5.40|
71735495|NCT01393639|142985828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.74|||||TWO_SIDED|90.0|-27.19|3.72|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||3.72|-27.19|
71735496|NCT01393639|142985829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-12.92|19.61|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||19.61|-12.92|
71735497|NCT01393639|142985829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.52|||||TWO_SIDED|90.0|-22.86|9.81|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||9.81|-22.86|
71735498|NCT01393639|142985829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|90.0|-12.11|20.55|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||20.55|-12.11|
71735499|NCT01393639|142985829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.83|||||TWO_SIDED|90.0|-3.49|29.15|||||Statistical analysis was performed using a repeated measures mixed model with fixed effects for treatment and visit, treatment by visit interaction and baseline value; unstructured covariance matrix was used.|||29.15|-3.49|
71735500|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|11.36|||||TWO_SIDED|95.0|-6.84|29.56|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||29.56|-6.84|
71773674|NCT03607422|143047514|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 30 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|33.3|||<|0.001|TWO_SIDED|95.0|26.9|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||39.8|26.9|<0.001
71773675|NCT03607422|143047514|SUPERIORITY|The overall type I error rate of the primary and secondary endpoints for upadacitinib 15 mg was strongly controlled using a graphical multiple testing procedure at the two-sided 0.05 level following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|Adjusted Response Rate Difference|19.1|||<|0.001|TWO_SIDED|95.0|13.3|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||24.9|13.3|<0.001
71773676|NCT03607422|143047515|SUPERIORITY||Adjusted Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|45.9|73.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||73.8|45.9|<0.001
71773677|NCT03607422|143047515|SUPERIORITY||Adjusted Response Rate Difference|55.8|||<|0.001|TWO_SIDED|95.0|41.1|70.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.4|41.1|<0.001
71773678|NCT03607422|143047516|SUPERIORITY||Adjusted Response Rate Difference|53.9|||<|0.001|TWO_SIDED|95.0|40.6|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.3|40.6|<0.001
71773679|NCT03607422|143047516|SUPERIORITY||Adjusted Response Rate Difference|39.4|||<|0.001|TWO_SIDED|95.0|25.7|53.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.1|25.7|<0.001
71773680|NCT03607422|143047517|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|40.0|66.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.1|40.0|<0.001
71773681|NCT03607422|143047517|SUPERIORITY||Adjusted Response Rate Difference|35.0|||<|0.001|TWO_SIDED|95.0|21.8|48.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.2|21.8|<0.001
71773682|NCT03607422|143047518|SUPERIORITY||Adjusted Response Rate Difference|60.2|||<|0.001|TWO_SIDED|95.0|47.5|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|47.5|<0.001
71889876|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.394|ONE_SIDED|97.5|-410.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-410|0.394
71773683|NCT03607422|143047518|SUPERIORITY||Adjusted Response Rate Difference|46.7|||<|0.001|TWO_SIDED|95.0|33.4|59.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.9|33.4|<0.001
71773684|NCT03607422|143047519|SUPERIORITY||Adjusted Response Rate Difference|46.4|||<|0.001|TWO_SIDED|95.0|33.2|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.6|33.2|<0.001
71773685|NCT03607422|143047519|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|21.4|48.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.4|21.4|<0.001
71735501|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.15|||||TWO_SIDED|95.0|-5.88|30.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||30.19|-5.88|
71735502|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.54|||||TWO_SIDED|95.0|0.91|38.17|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||38.17|0.91|
71773686|NCT03607422|143047520|SUPERIORITY||Adjusted Response Rate Difference|46.2|||<|0.001|TWO_SIDED|95.0|32.4|60.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||60.0|32.4|<0.001
71889877|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|78.4||||0.004|ONE_SIDED|97.5|52.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||52.1|0.004
71735503|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.09|||||TWO_SIDED|95.0|3.6|40.58|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||40.58|3.60|
71735504|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.43|||||TWO_SIDED|95.0|-9.38|26.25|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.25|-9.38|
71735505|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.5|||||TWO_SIDED|95.0|-1.84|34.84|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||34.84|-1.84|
71735506|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.88|||||TWO_SIDED|95.0|-28.58|10.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.80|-28.58|
71773687|NCT03607422|143047520|SUPERIORITY||Adjusted Response Rate Difference|31.3|||<|0.001|TWO_SIDED|95.0|17.3|45.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.3|17.3|<0.001
71889878|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|80.3||||0.002|ONE_SIDED|97.5|54.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||54.7|0.002
71889879|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||97.5||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.||||0.992
71889880|NCT00630331|143301577|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.4|ONE_SIDED|97.5|-429.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-429.4|0.400
71889881|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.7||||0.078|ONE_SIDED|97.5|33.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.5|0.078
71889882|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|87.3||||0.104|ONE_SIDED|97.5|4.6|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||4.6|0.104
71889883|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.03|ONE_SIDED|97.5|36.3|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||36.3|0.030
71889884|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|50.0||||0.376|ONE_SIDED|97.5|17.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||17.5|0.376
71735507|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.31|||||TWO_SIDED|95.0|-4.85|35.49|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.49|-4.85|
71735508|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.66|||||TWO_SIDED|95.0|6.8|46.53|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||46.53|6.80|
71735509|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.19|||||TWO_SIDED|95.0|-7.01|33.4|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||33.40|-7.01|
71735510|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-11.56|29.33|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||29.33|-11.56|
71773688|NCT03607422|143047521|SUPERIORITY||Adjusted Response Rate Difference|5.0||||0.075|TWO_SIDED|95.0|-0.5|10.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||10.6|-0.5|0.075
71773689|NCT03607422|143047521|SUPERIORITY||Adjusted Response Rate Difference|12.7||||0.005|TWO_SIDED|95.0|3.9|21.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||21.5|3.9|0.005
71773690|NCT03607422|143047522|SUPERIORITY||Adjusted Response Rate Difference|3.2||||0.151|TWO_SIDED|95.0|-1.2|7.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||7.6|-1.2|0.151
71832614|NCT01852071|143169297|SUPERIORITY||Difference in percentages|9.09|||||TWO_SIDED|95.0|-9.55|41.28||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||41.28|-9.55|
71660194|NCT04135196|142834766|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD iBMD was not proportional to strain rate. Raw change in iBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.563, F=21.225, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.009, Std. Error of estimate of B=0.002, Beta=0.739, t=5.669, p=\<0.001, 95% CI of B: \[0.005, 0.012\]~Contrast between the high strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.716, t=5.495, p=\<0.001, 95% CI of B: \[0.005, 0.012\]"|||<0.001
71773691|NCT03607422|143047523|SUPERIORITY||Adjusted Response Rate Difference|12.9||||0.008|TWO_SIDED|95.0|3.4|22.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||22.3|3.4|0.008
71773692|NCT03607422|143047524|SUPERIORITY||Adjusted Response Rate Difference|-18.0|||<|0.001|TWO_SIDED|95.0|-28.0|-8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-8.0|-28.0|<0.001
71773693|NCT03607422|143047524|SUPERIORITY||Adjusted Response Rate Difference|-17.9||||0.001|TWO_SIDED|95.0|-28.1|-7.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||-7.7|-28.1|0.001
71773694|NCT03607422|143047525|SUPERIORITY||Adjusted Response Rate Difference|51.5|||<|0.001|TWO_SIDED|95.0|34.8|68.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.3|34.8|<0.001
71773695|NCT03607422|143047525|SUPERIORITY||Adjusted Response Rate Difference|29.2||||0.001|TWO_SIDED|95.0|11.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.6|11.8|0.001
71773696|NCT03607422|143047526|SUPERIORITY||Adjusted Response Rate Difference|53.2|||<|0.001|TWO_SIDED|95.0|38.4|68.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.0|38.4|<0.001
71832615|NCT01852071|143169297|SUPERIORITY||Difference in percentages|12.0|||||TWO_SIDED|95.0|-5.62|31.22||||||Percentage of patients alive at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients alive at 2-years post-treatment with OTL-101. Results are reported as percentage difference in OS of historical control group from OTL-101 on-study subjects.||31.22|-5.62|
71773697|NCT03607422|143047526|SUPERIORITY||Adjusted Response Rate Difference|31.8|||<|0.001|TWO_SIDED|95.0|16.5|47.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||47.1|16.5|<0.001
71773698|NCT03607422|143047527|SUPERIORITY||Adjusted Response Rate Difference|48.9|||<|0.001|TWO_SIDED|95.0|33.8|64.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.1|33.8|<0.001
71773699|NCT03607422|143047527|SUPERIORITY||Adjusted Response Rate Difference|37.3|||<|0.001|TWO_SIDED|95.0|21.1|53.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||53.6|21.1|<0.001
71773700|NCT03607422|143047528|SUPERIORITY||Adjusted Response Rate Difference|53.8|||<|0.001|TWO_SIDED|95.0|37.4|70.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||70.2|37.4|<0.001
71773701|NCT03607422|143047528|SUPERIORITY||Adjusted Response Rate Difference|42.0|||<|0.001|TWO_SIDED|95.0|24.3|59.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.7|24.3|<0.001
71832616|NCT01852071|143169298|SUPERIORITY||Difference in percentages|50.0|||||TWO_SIDED|95.0|22.71|76.96||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||76.96|22.71|
71889885|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|58.6||||0.085|ONE_SIDED|97.5|32.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||32.9|0.085
71889886|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|100.0||||0.033|ONE_SIDED|97.5|33.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||33.9|0.033
71889887|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|73.6||||0.265|ONE_SIDED|97.5|-30.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-30.0|0.265
71889888|NCT00630331|143301578|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|51.7||||0.319|ONE_SIDED|97.5|19.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||19.4|0.319
71889889|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|69.5|||<|0.001|ONE_SIDED|97.5|55.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||55.0|<0.001
71889890|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|89.3|||<|0.001|ONE_SIDED|97.5|73.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||73.0|<0.001
71889891|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|75.6||||0.04|ONE_SIDED|97.5|35.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||35.1|0.040
71735511|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.21|||||TWO_SIDED|95.0|5.35|45.07|||||Non-responder imputation was used to handle dropouts.|Week 4 comparisons presented in this section for comparison to placebo.||45.07|5.35|
71735512|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-17.4|21.85|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||21.85|-17.40|
71735513|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.6|||||TWO_SIDED|95.0|-4.24|35.45|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.45|-4.24|
71735514|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|22.22|||||TWO_SIDED|95.0|2.2|42.23|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||42.23|2.20|
71735515|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.96|||||TWO_SIDED|95.0|-14.6|24.53|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||24.53|-14.60|
71735516|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-4.51|35.63|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||35.63|-4.51|
71735517|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|23.18|||||TWO_SIDED|95.0|3.31|43.06|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||43.06|3.31|
71735518|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-5.13|||||TWO_SIDED|95.0|-24.73|14.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||14.45|-24.73|
71735519|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-23.79|15.09|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||15.09|-23.79|
71735520|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
71735521|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
71735522|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-34.1|||||TWO_SIDED|95.0|-53.4|-14.8|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-14.80|-53.40|
71735523|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.89|||||TWO_SIDED|95.0|-29.68|9.88|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||9.88|-29.68|
71735524|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.44|||||TWO_SIDED|95.0|-18.02|20.92|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||20.92|-18.02|
71735525|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.02|||||TWO_SIDED|95.0|-31.84|7.79|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||7.79|-31.84|
71735526|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-20.96|||||TWO_SIDED|95.0|-40.98|-0.94|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||-0.94|-40.98|
71735527|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.58|||||TWO_SIDED|95.0|-27.82|12.65|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||12.65|-27.82|
71773702|NCT03607422|143047529|SUPERIORITY||Adjusted Response Rate Difference|45.3|||<|0.001|TWO_SIDED|95.0|28.0|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||62.7|28.0|<0.001
71773703|NCT03607422|143047529|SUPERIORITY||Adjusted Response Rate Difference|29.8||||0.002|TWO_SIDED|95.0|10.7|48.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||48.8|10.7|0.002
71735528|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.96|||||TWO_SIDED|95.0|-21.36|19.43|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||19.43|-21.36|
71735529|NCT01393639|142985830|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-18.22|||||TWO_SIDED|95.0|-38.18|1.73|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||1.73|-38.18|
71735530|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.27|||||TWO_SIDED|95.0|-11.93|7.38|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||7.38|-11.93|
71735531|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.87|||||TWO_SIDED|95.0|-9.15|12.91|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||12.91|-9.15|
71735532|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.07|||||TWO_SIDED|95.0|-9.09|13.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.23|-9.09|
71735533|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.71|||||TWO_SIDED|95.0|4.19|33.23|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||33.23|4.19|
71735534|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.59|||||TWO_SIDED|95.0|-13.19|4.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||4.00|-13.19|
71773704|NCT03607422|143047530|SUPERIORITY||Adjusted Response Rate Difference|17.1|||<|0.001|TWO_SIDED|95.0|7.5|26.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||26.7|7.5|<0.001
71773705|NCT03607422|143047530|SUPERIORITY||Adjusted Response Rate Difference|13.7||||0.006|TWO_SIDED|95.0|3.9|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.5|3.9|0.006
71660195|NCT04135196|142834767|OTHER|||||||0.202|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain magnitude. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.077, F=1.665, df1=2, df2=40, p=0.202~Contrast between the low strain magnitude group and the control group: B=-0.005, Std. Error of estimate of B=0.003, Beta=-0.303, t=-1.689, p=0.099, 95% CI of B: \[-0.012, 0.001\]~Contrast between the high strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.003, Beta=-0.266, t=-1.484, p=0.146, 95% CI of B: \[-0.010, 0.002\]"|||0.202
71660196|NCT04135196|142834767|OTHER|||||||0.381|||||||Regression, Linear|||The null hypothesis was that change in UD cBMD was not proportional to strain rate. Raw change in cBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.057, F=0.995, df1=2, df2=33, p=0.381~Contrast between the low strain rate group and the control group: B=0.004, Std. Error of estimate of B=0.003, Beta=0.254, t=1.327, p=0.194, 95% CI of B: \[-0.002, 0.011\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.003, Beta=0.038, t=0.200, p=0.843, 95% CI of B: \[-0.006, 0.008\]"|||0.381
71660197|NCT04135196|142834768|OTHER|||||||0.697|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain magnitude. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.018, F=0.365, df1=2, df2=40, p=0.697~Contrast between the low strain magnitude group and the control group: B=-0.004, Std. Error of estimate of B=0.004, Beta=-0.158, t=-0.854, p=0.398, 95% CI of B: \[-0.012, 0.005\]~Contrast between the high strain magnitude group and the control group: B=-0.002, Std. Error of estimate of B=0.004, Beta=-0.078, t=-0.423, p=0.675, 95% CI of B: \[-0.010, 0.006\]"|||0.697
71660198|NCT04135196|142834768|OTHER|||||||0.018|||||||Regression, Linear|||The null hypothesis was that change in UD ecBMD was not proportional to strain rate. Raw change in ecBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.215, F=4.516, df1=2, df2=33, p=0.018~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.005, Beta=0.484, t=2.773, p=0.009, 95% CI of B: \[0.004, 0.0524\]~Contrast between the high strain rate group and the control group: B=0.012, Std. Error of estimate of B=0.005, Beta=0.406, t=2.325, p=0.026, 95% CI of B: \[0.001, 0.022\]"|||0.018
71735535|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.74|||||TWO_SIDED|95.0|-0.92|26.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||26.41|-0.92|
71735536|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.16|-14.60|
71735537|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.29|||||TWO_SIDED|95.0|-2.9|27.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.48|-2.90|
71735538|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|7.71|41.17|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||41.17|7.71|
71735539|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|16.54|||||TWO_SIDED|95.0|0.8|32.29|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||32.29|0.80|
71735540|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.98|12.98|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||12.98|-12.98|
71735541|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.32|||||TWO_SIDED|95.0|3.16|35.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||35.48|3.16|
71735542|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-18.46|9.57|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||9.57|-18.46|
71735543|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.1|||||TWO_SIDED|95.0|-4.49|28.7|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||28.70|-4.49|
71735544|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|24.44|||||TWO_SIDED|95.0|6.63|42.24|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||42.24|6.63|
71735545|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|26.99|||||TWO_SIDED|95.0|9.33|44.65|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||44.65|9.33|
71735546|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-7.53|25.31|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||25.31|-7.53|
71735547|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.4|||||TWO_SIDED|95.0|3.88|38.91|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||38.91|3.88|
71735548|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-6.8|24.57|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||24.57|-6.80|
71735549|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|18.58|||||TWO_SIDED|95.0|1.96|35.2|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||35.20|1.96|
71735550|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|35.55|||||TWO_SIDED|95.0|17.89|53.21|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||53.21|17.89|
71735551|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|29.21|||||TWO_SIDED|95.0|11.94|46.49|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||46.49|11.94|
71735552|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|13.33|||||TWO_SIDED|95.0|-2.96|29.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||29.63|-2.96|
71735553|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|32.31|||||TWO_SIDED|95.0|14.83|49.8|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||49.80|14.83|
71735554|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-15.79|15.79|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.79|-15.79|
71773706|NCT03607422|143047531|SUPERIORITY||LS Mean Difference|-55.93|STANDARD_ERROR_OF_MEAN|7.284|<|0.001|TWO_SIDED|95.0|-70.32|-41.55|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-41.55|-70.32|<0.001
71773707|NCT03607422|143047531|SUPERIORITY||LS Mean Difference|-36.54|STANDARD_ERROR_OF_MEAN|7.384|<|0.001|TWO_SIDED|95.0|-51.12|-21.96|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-21.96|-51.12|<0.001
71735555|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.49|||||TWO_SIDED|95.0|-12.67|19.67|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||19.67|-12.67|
71773708|NCT03607422|143047532|SUPERIORITY||LS Mean Difference|-42.62|STANDARD_ERROR_OF_MEAN|6.432|<|0.001|TWO_SIDED|95.0|-55.34|-29.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-29.90|-55.34|<0.001
71735556|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.66|||||TWO_SIDED|95.0|-10.13|23.47|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||23.47|-10.13|
71735557|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.75|||||TWO_SIDED|95.0|-16.25|14.74|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||14.74|-16.25|
71735558|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-8.19|25.96|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||25.96|-8.19|
71735559|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.13|||||TWO_SIDED|95.0|-10.5|22.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||22.77|-10.50|
71735560|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.01|||||TWO_SIDED|95.0|-28.03|-2.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-2.00|-28.03|
71735561|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.86|||||TWO_SIDED|95.0|-24.93|3.19|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.19|-24.93|
71735562|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-10.67|||||TWO_SIDED|95.0|-24.83|3.48|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||3.48|-24.83|
71735563|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.96|||||TWO_SIDED|95.0|-10.96|22.9|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||22.90|-10.96|
71735564|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-21.54|||||TWO_SIDED|95.0|-37.22|-5.86|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-5.86|-37.22|
71735565|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-7.03|||||TWO_SIDED|95.0|-25.01|10.95|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||10.95|-25.01|
71735566|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.12|||||TWO_SIDED|95.0|-14.17|24.41|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||24.41|-14.17|
71735567|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-21.22|15.67|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.67|-21.22|
71735568|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-25.84|||||TWO_SIDED|95.0|-42.54|-9.14|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-9.14|-42.54|
71735569|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.29|||||TWO_SIDED|95.0|-28.22|9.62|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||9.62|-28.22|
71735570|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.04|||||TWO_SIDED|95.0|-16.94|23.02|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||23.02|-16.94|
71735571|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.59|||||TWO_SIDED|95.0|-14.26|25.45|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||25.45|-14.26|
71735572|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-23.42|||||TWO_SIDED|95.0|-42.26|-4.59|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-4.59|-42.26|
71735573|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-13.73|||||TWO_SIDED|95.0|-33.35|5.87|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||5.87|-33.35|
71773709|NCT03607422|143047532|SUPERIORITY||LS Mean Difference|-35.66|STANDARD_ERROR_OF_MEAN|6.447|<|0.001|TWO_SIDED|95.0|-48.41|-22.9|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-22.90|-48.41|<0.001
71660199|NCT04135196|142834769|OTHER|||||||0.073|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain magnitude. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.123, F=2.799, df1=2, df2=40, p=0.073~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.413, t=2.361, p=0.023, 95% CI of B: \[0.000, 0.006\]~Contrast between the high strain magnitude group and the control group: B=0.002, Std. Error of estimate of B=0.001, Beta=0.198, t=1.129, p=0.265, 95% CI of B: \[-0.001, 0.004\]"|||0.073
71660200|NCT04135196|142834769|OTHER||||||<|0.001|||||||Regression, Linear|||The null hypothesis was that change in UD tBMD was not proportional to strain rate. Raw change in tBMD was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.480, F=15.256, df1=2, df2=33, p=\<0.001~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.002, Beta=0.590, t=4.153, p=\<0.001, 95% CI of B: \[0.004, 0.012\]~Contrast between the high strain rate group and the control group: B=0.001, Std. Error of estimate of B=0.002, Beta=0.734, t=5.164, p=\<0.001, 95% CI of B: \[0.006, 0.014\]"|||<0.001
71660201|NCT04135196|142834770|OTHER|||||||0.101|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain magnitude. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.108, F=2.428, df1=2, df2=40, p=0.101~Contrast between the low strain magnitude group and the control group: B=0.053, Std. Error of estimate of B=0.024, Beta=0.388, t=2.200, p=0.034, 95% CI of B: \[0.004, 0.101\]~Contrast between the high strain magnitude group and the control group: B=0.029, Std. Error of estimate of B=0.022, Beta=0.226, t=1.280, p=0.208, 95% CI of B: \[-0.017, 0.074\]"|||0.101
71660202|NCT04135196|142834770|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD iBV was not proportional to strain rate. Raw change in iBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=01.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.015, Std. Error of estimate of B=0.025, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
71735574|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|3.23|||||TWO_SIDED|95.0|-17.26|23.74|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||23.74|-17.26|
71735575|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-3.09|||||TWO_SIDED|95.0|-23.27|17.07|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||17.07|-23.27|
71735576|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.13|||||TWO_SIDED|95.0|-22.77|10.5|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||10.50|-22.77|
71735577|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.63|||||TWO_SIDED|95.0|-19.63|14.35|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||14.35|-19.63|
71735578|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.53|||||TWO_SIDED|95.0|-17.06|18.12|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||18.12|-17.06|
71773710|NCT03607422|143047533|SUPERIORITY||Adjusted Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|36.9|68.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||68.1|36.9|<0.001
71773711|NCT03607422|143047533|SUPERIORITY||Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|21.2|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||54.9|21.2|<0.001
71773712|NCT03607422|143047534|SUPERIORITY||Adjusted Response Rate Difference|55.9|||<|0.001|TWO_SIDED|95.0|35.5|76.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||76.3|35.5|<0.001
71773713|NCT03607422|143047534|SUPERIORITY||Adjusted Response Rate Difference|49.6|||<|0.001|TWO_SIDED|95.0|26.3|72.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||72.9|26.3|<0.001
71735579|NCT01393639|142985831|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.89|||||TWO_SIDED|95.0|-23.24|9.46|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.46|-23.24|
71735580|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||0.00|0.00|
71735581|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.34|||||TWO_SIDED|95.0|-1.54|10.24|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||10.24|-1.54|
71735582|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
71773714|NCT03607422|143047535|SUPERIORITY||LS Mean Difference|-44.9|STANDARD_ERROR_OF_MEAN|6.492|<|0.001|TWO_SIDED|95.0|-57.74|-32.06|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-32.06|-57.74|<0.001
71773715|NCT03607422|143047535|SUPERIORITY||LS Mean Difference|-29.98|STANDARD_ERROR_OF_MEAN|6.383|<|0.001|TWO_SIDED|95.0|-42.6|-17.36|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category|Difference = Upadacitinib - Placebo|||-17.36|-42.60|<0.001
71735583|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.38|||||TWO_SIDED|95.0|-0.6|13.37|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||13.37|-0.60|
71735584|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-2.08|6.52|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||6.52|-2.08|
71735585|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.69|||||TWO_SIDED|95.0|0.55|16.83|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to placebo.||16.83|0.55|
71735586|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||0.00|0.00|
71773716|NCT03607422|143047536|SUPERIORITY||Adjusted Response Rate Difference|27.8||||0.016|TWO_SIDED|95.0|5.2|50.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||50.4|5.2|0.016
71773717|NCT03607422|143047536|SUPERIORITY||Adjusted Response Rate Difference|22.3||||0.062|TWO_SIDED|95.0|-1.1|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||45.7|-1.1|0.062
71773718|NCT03607422|143047537|SUPERIORITY||Adjusted Response Rate Difference|38.9|||<|0.001|TWO_SIDED|95.0|18.4|59.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||59.4|18.4|<0.001
71773719|NCT03607422|143047537|SUPERIORITY||Adjusted Response Rate Difference|5.9||||0.51|TWO_SIDED|95.0|-11.7|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||23.6|-11.7|0.510
71773720|NCT03693170|143047538|OTHER|||||||||||||||||"The null hypothesis that the true response rate is 30% will be tested against a one-sided alternative.~The cORR will be provided with a corresponding Clopper-Pearson (exact) binomial 95% CI for the Efficacy Set.~This design yields a 1-sided type I error rate equal to 1.6% and power of 80% when the true response rate is 45%."|If 37 or more confirmed responses were observed in the 90 treated subjects with a centrally confirmed BRAFV600E mutation, corresponding to a lower limit of Clopper-Pearson (exact) binomial 95% CI exceeding 30%, the study was considered to have met its primary endpoint. If more than 90 subjects were enrolled, the lower limit of Clopper-Pearson was to be used for decision.|||
71773721|NCT03402659|143047555|OTHER||Mean Difference (Final Values)|-0.06098|STANDARD_ERROR_OF_MEAN|0.105548||0.564|TWO_SIDED|95.0|-0.26973|0.14777|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.14777|-0.26973|0.564
71773722|NCT03402659|143047556|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.72||0.823|TWO_SIDED|95.0|-6.0|4.8|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||4.8|-6.0|0.823
71773723|NCT03402659|143047557|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.806|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Mean change from baseline neflamapimod vs placebo||0.6|-0.4|0.806
71832617|NCT01852071|143169298|SUPERIORITY||Difference in percentages|36.36|||||TWO_SIDED|95.0|9.8|69.21||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||69.21|9.80|
71889892|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.9||||0.37|ONE_SIDED|97.5|18.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||18.2|0.37
71735587|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.51|||||TWO_SIDED|95.0|0.53|16.48|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||16.48|0.53|
71735588|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|4.96|26.14|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||26.14|4.96|
71735589|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.02|||||TWO_SIDED|95.0|6.27|27.76|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||27.76|6.27|
71735590|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-1.57|10.46|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||10.46|-1.57|
71735591|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.21|||||TWO_SIDED|95.0|4.83|25.59|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to placebo.||25.59|4.83|
71773724|NCT03402659|143047558|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.39||0.489|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.5|-1.0|0.489
71773725|NCT03402659|143047559|OTHER||Mean Difference (Final Values)|-18.8|STANDARD_ERROR_OF_MEAN|8.6||0.031|TWO_SIDED|95.0|-35.8|-1.8|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-1.8|-35.8|0.031
71773726|NCT03402659|143047560|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.79||0.012|TWO_SIDED|95.0|-3.6|-0.5|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||-0.5|-3.6|0.012
71773727|NCT03402659|143047561|OTHER||Mean Difference (Final Values)|-117.4|STANDARD_ERROR_OF_MEAN|314.0||0.709|TWO_SIDED|95.0|-738.9|504.2|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||504.2|-738.9|0.709
71773728|NCT03402659|143047562|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|16.03||0.192|TWO_SIDED|95.0|-52.7|10.7|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||10.7|-52.7|0.192
71773729|NCT03402659|143047563|OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|11.43||0.068|TWO_SIDED|95.0|-43.6|1.6|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||1.6|-43.6|0.068
71832618|NCT01852071|143169298|SUPERIORITY||Difference in percentages|44.0|||||TWO_SIDED|95.0|22.78|65.23||||||Percentage of patients with EvFS at 2-years post-treatment in the historical control groups (all control patients) were compared to the percentage of study patients with EvFS at 2-years post-treatment with OTL-101. Results are reported as percentage difference in EvFS of historical control group from OTL-101 on-study subjects.||65.23|22.78|
71832619|NCT01839331|143169324|SUPERIORITY|||||||0.004||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.004
71832620|NCT01839331|143169324|SUPERIORITY|||||||0.017||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.017
71832621|NCT01839331|143169324|SUPERIORITY|||||||0.093||||||Adjusted for injection volume and baseline WOMAC score.|ANOVA|||||||0.093
71832622|NCT01839331|143169325|SUPERIORITY|Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.||||||0.0442|||||||ANOVA|||||||0.0442
71832623|NCT01839331|143169326|SUPERIORITY|||||||0.4133||||||Adjusted for injection volume (4 mL or 10 mL) and baseline WOMAC score.|ANOVA|||||||0.4133
71832624|NCT01839331|143169327|SUPERIORITY|||||||0.0122||||||Adjusted for injection volume (4 mL or 10 mL) and baseline PGA|ANOVA|||||||0.0122
71735592|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-9.62|5.18|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||5.18|-9.62|
71735593|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.32|||||TWO_SIDED|95.0|-2.96|19.6|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||19.60|-2.96|
71735594|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|8.88|||||TWO_SIDED|95.0|-2.72|20.5|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||20.50|-2.72|
71735595|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|12.57|||||TWO_SIDED|95.0|0.26|24.89|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||24.89|0.26|
71832625|NCT00703820|143169328|SUPERIORITY||Odds Ratio (OR)|1.87||||0.035|TWO_SIDED|95.0|1.03|3.41||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using an exact, risk-group stratified, two-sided test.|The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.|The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.||3.41|1.03|0.035
71832626|NCT01985334|143169373|SUPERIORITY_OR_OTHER|||||||0.018|||||||linear mixed model|||||||0.0180
71832627|NCT01985334|143169374|NON_INFERIORITY_OR_EQUIVALENCE|"H0: Glycopyrronium (50 μg o.d.) \[randomized group B2\] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~H0: μFEV1, NVA237 - μFEV1, LABA and/or LAMA \< -40 mL Ha: Glycopyrronium (50 μg o.d.) \[randomized group B2\] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~Ha: μFEV1, NVA237 - μFEV1, LABA and/or LAMA ≥ -40 mL"|||||<|0.0001|||||||linear mixed model|||||||<0.0001
71832628|NCT01985334|143169375|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
71832629|NCT01985334|143169376|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
71735596|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22|||||TWO_SIDED|95.0|-7.23|11.67|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||11.67|-7.23|
71735597|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.29|||||TWO_SIDED|95.0|3.94|30.64|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to placebo.||30.64|3.94|
71735598|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.22|||||TWO_SIDED|95.0|-14.6|10.16|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||10.16|-14.60|
71735599|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.91|||||TWO_SIDED|95.0|-8.22|20.04|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||20.04|-8.22|
71735600|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|15.55|||||TWO_SIDED|95.0|-0.29|31.4|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||31.40|-0.29|
71735601|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.16|||||TWO_SIDED|95.0|-4.7|25.03|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||25.03|-4.70|
71735602|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.44|||||TWO_SIDED|95.0|-16.16|7.27|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||7.27|-16.16|
71735603|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.97|||||TWO_SIDED|95.0|-0.68|30.63|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to placebo.||30.63|-0.68|
71735604|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
71832630|NCT01985334|143169377|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
71832631|NCT01985334|143169378|NON_INFERIORITY_OR_EQUIVALENCE|A difference of 0.6 points in TDI was adopted as boundary for non-inferiority|||||<|0.0001|||||||linear mixed model|||||||<0.0001
71832632|NCT01985334|143169379|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
71832633|NCT01985334|143169380|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||linear mixed model|||||||<0.0001
71832634|NCT03988023|143169389|SUPERIORITY|||||||0.32|||||||MMRM|||||||0.32
71832635|NCT03988023|143169390|SUPERIORITY|||||||0.3|||||||MMRM|||||||0.30
71832636|NCT00475501|143169406|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.9|STANDARD_DEVIATION|2.57|<|0.001|TWO_SIDED|95.0|7.86|18.0||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis||mean difference is for subjects reveiving testosterone (groups T and T/F) vs. subjects not receiving testosterone (F and Placebo)|The studies was powered for 1-RM strength based on a 1.18-alpha increase reported in the literature||18.0|7.86|<0.001
71832637|NCT00475501|143169407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|STANDARD_DEVIATION|0.311||0.015|TWO_SIDED|95.0|0.16|1.31||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on grip strength. We employed 2x2 analysis to determine effects of testosterone, finasteride and interaction.||1.31|0.16|0.015
71832638|NCT00475501|143169408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.19|STANDARD_DEVIATION|1.142|<|0.001|TWO_SIDED|95.0|1.95|6.43||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered on lumbar spine bone mineral density. We employed a 2x2 analysis for effects ot testosterone, finasteride and interaction||6.43|1.95|<0.001
71832639|NCT00475501|143169409|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737|STANDARD_ERROR_OF_MEAN|0.343||0.037|TWO_SIDED|95.0|-1.41|-0.064||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study is was not powered for score on Geriatric Depression Scale||-0.064|-1.41|0.037
71832640|NCT00475501|143169410|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.871|STANDARD_ERROR_OF_MEAN|1.108||0.012|TWO_SIDED|95.0|0.699|5.04||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for 30-minute recall on Rey figure test||5.04|0.699|0.012
71832641|NCT00475501|143169411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.642|STANDARD_ERROR_OF_MEAN|2.272||0.779|TWO_SIDED|95.0|-5.095|3.811||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Trials A test||3.811|-5.095|0.779
71832642|NCT00475501|143169412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.587|STANDARD_ERROR_OF_MEAN|0.743||0.433|TWO_SIDED|95.0|-0.869|2.043||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Benton test||2.043|-0.869|0.433
71832643|NCT00475501|143169413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|0.54|<|0.001|TWO_SIDED|95.0|3.07|5.18||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||This study was powered for hematocrit based on literature report that testosterone \> 2 alpha increase in hematocrit||5.18|3.07|<0.001
71832644|NCT00475501|143169414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1419|STANDARD_ERROR_OF_MEAN|0.2529||0.6219|TWO_SIDED|95.0|-0.353|6.37||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for dietary protein intake||6.37|-0.353|0.6219
71735605|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.09|||||TWO_SIDED|95.0|-5.9|18.1|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||18.10|-5.90|
71832645|NCT00475501|143169415|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.33|STANDARD_DEVIATION|1.83||0.0051|TWO_SIDED|95.0|1.73|8.94||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was powered for prostate volume based on a literature report that testosterone increases prostate volume 1.85 alpha per year. We employed a 2x2 analysis for effects of testosterone, finasteride and interaction.||8.94|1.73|0.0051
71832646|NCT00475501|143169416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.868|STANDARD_ERROR_OF_MEAN|0.668||0.196|TWO_SIDED|95.0|-3.434|1.698||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone (\[T-placebo plus T-finasteride\] vs. \[vehicle-placebo plus vehicle-finasteride\]).|Mixed Models Analysis|||The study was not powered for score on Lif Satisfaction A test||1.698|-3.434|0.196
71832647|NCT01803555|143169443|NON_INFERIORITY|The noninferiority of BF Spiromax to Symbicort Turbohaler was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -15 L/min.|Least Square (LS) mean difference|-2.957||||0.3387|TWO_SIDED|95.0|-9.02|3.11|||Mixed Models Analysis|Analysis included effects due to baseline weekly average of daily trough AM PEF, gender, age, treatment, time, and treatment-by-time interaction.||||3.11|-9.02|0.3387
71832648|NCT00212134|143169448|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71832649|NCT00212134|143169449|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71832650|NCT00212134|143169450|OTHER|||||||0.82|||||||Chi-squared|||||||0.82
71660203|NCT04135196|142834771|OTHER|||||||0.676|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain magnitude. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.019, F=0.395, df1=2, df2=40, p=0.676~Contrast between the low strain magnitude group and the control group: B=0.012, Std. Error of estimate of B=0.015, Beta=0.146, t=0.787, p=0.436, 95% CI of B: \[-0.019, 0.042\]~Contrast between the high strain magnitude group and the control group: B=0.001, Std. Error of estimate of B=0.014, Beta=0.013, t=0.070, p=0.945, 95% CI of B: \[-0.028, 0.029\]"|||0.676
71832651|NCT00212134|143169451|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71660204|NCT04135196|142834771|OTHER|||||||0.289|||||||Regression, Linear|||The null hypothesis was that change in UD cBV was not proportional to strain rate. Raw change in cBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|Overall model fit: R\^2=0.072, F=1.288, df1=2, df2=33, p=0.289 Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.018, Beta=0.154, t=0.814, p=0.422, 95% CI of B: \[-0.022, 0.051\] Contrast between the high strain rate group and the control group: B=0.029, Std. Error of estimate of B=0.018, Beta=0.304, t=1.604, p=0.118, 95% CI of B: \[-0.008, 0.066\]|||0.289
71660205|NCT04135196|142834772|OTHER|||||||0.096|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain magnitude. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.111, F=2.491, df1=2, df2=40, p=0.096~Contrast between the low strain magnitude group and the control group: B=0.026, Std. Error of estimate of B=0.012, Beta=0.391, t=2.222, p=0.032, 95% CI of B: \[0.032, 0.049\]~Contrast between the high strain magnitude group and the control group: B=0.015, Std. Error of estimate of B=0.011, Beta=0.240, t=1.362, p=0.181, 95% CI of B: \[-0.007, 0.037\]"|||0.096
71660206|NCT04135196|142834772|OTHER|||||||0.344|||||||Regression, Linear|||The null hypothesis was that change in UD ecBV was not proportional to strain rate. Raw change in ecBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.063, F=1.103, df1=2, df2=33, p=0.344~Contrast between the low strain rate group and the control group: B=0.014, Std. Error of estimate of B=0.015, Beta=0.113, t=0.595, p=0.556, 95% CI of B: \[-0.036, 0.065\]~Contrast between the high strain rate group and the control group: B=0.038, Std. Error of estimate of B=0.025, Beta=0.283, t=1.481, p=0.148, 95% CI of B: \[-0.014, 0.089\]"|||0.344
71660207|NCT04135196|142834773|OTHER|||||||0.332|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain magnitude. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=1.132, df1=2, df2=40, p=0.332~Contrast between the low strain magnitude group and the control group: B=0.016, Std. Error of estimate of B=0.011, Beta=0.271, t=1.493, p=0.143, 95% CI of B: \[-0.006, 0.039\]~Contrast between the high strain magnitude group and the control group: B=0.007, Std. Error of estimate of B=0.010, Beta=0.115, t=635, p=0.529, 95% CI of B: \[-0.014, 0.028\]"|||0.332
71660208|NCT04135196|142834773|OTHER|||||||0.399|||||||Regression, Linear|||The null hypothesis was that change in UD tBV was not proportional to strain rate. Raw change in tBV was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"Overall model fit: R\^2=0.054, F=0.946, df1=2, df2=33, p=0.399~Contrast between the low strain rate group and the control group: B=0.008, Std. Error of estimate of B=0.012, Beta=0.119, t=0.619, p=0.540, 95% CI of B: \[-0.017, 0.032\]~Contrast between the high strain rate group and the control group: B=0.017, Std. Error of estimate of B=0.012, Beta=0.264, t=1.375, p=0.178, 95% CI of B: \[-0.008, 0.042\]"|||0.399
71660209|NCT04135196|142834774|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~There were no significant relationships found between change in cortical thickness and strain magnitude group at any time point (p\>0.05)."|||
71660210|NCT04135196|142834774|OTHER|||||||||||||||||The null hypothesis was that change in cortical thickness was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 3 months, there was a significant overall linear relationship between change in cortical thickness and strain rate group. Additionally, the coefficient representing the contrast between the control group and the high strain rate group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 3 months:~Overall model fit: R\^2=0.258, F=4.519, df1=2, df2=26, p=0.021~Contrast between the high strain rate group and the control group: B=0.036, Std. Error of estimate of B=0.012, Beta=0.574, t=2.967, p=0.006, 95% CI of B: \[0.011, 0.061\]"|||
71773730|NCT03402659|143047564|OTHER||Mean Difference (Final Values)|-110.1|STANDARD_ERROR_OF_MEAN|77.11||0.156|TWO_SIDED|95.0|-262.7|42.4|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||42.4|-262.7|0.156
71773731|NCT03402659|143047565|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.59|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|||Mean change from baseline neflamapimod vs placebo||0.0|-0.0|0.590
71832652|NCT00212134|143169452|SUPERIORITY|||||||0.008|||||||Fisher Exact|||||||0.008
71832653|NCT00212134|143169453|SUPERIORITY||Mean Difference (Final Values)|15.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.||||<0.05
71832654|NCT00212134|143169455|SUPERIORITY||Mean Difference (Final Values)|7.295|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||ITT comparison of mean PSI scores||||>0.05
71735606|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-10.3|10.3|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||10.30|-10.30|
71735607|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.84|||||TWO_SIDED|95.0|-8.96|12.64|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||12.64|-8.96|
71735608|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.44|||||TWO_SIDED|95.0|-7.27|16.16|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||16.16|-7.27|
71735609|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.2|||||TWO_SIDED|95.0|-7.37|15.77|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to placebo.||15.77|-7.37|
71735610|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.69|||||TWO_SIDED|95.0|-16.83|-0.55|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||-0.55|-16.83|
71735611|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.34|||||TWO_SIDED|95.0|-14.39|5.7|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||5.70|-14.39|
71735612|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.47|||||TWO_SIDED|95.0|-15.68|2.73|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||2.73|-15.68|
71735613|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.31|||||TWO_SIDED|95.0|-13.04|8.41|||||Non-responder imputation was used to handle dropouts.|Week 2 analysis presented in this section for comparison to prednisone 10 mg.||8.41|-13.04|
71735614|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-15.21|||||TWO_SIDED|95.0|-25.59|-4.83|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||-4.83|-25.59|
71735615|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-6.7|||||TWO_SIDED|95.0|-19.79|6.38|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||6.38|-19.79|
71773732|NCT01442038|143047566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.948||||0.48|TWO_SIDED|95.0|0.818|1.099||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.099|0.818|0.48
71735616|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.33|||||TWO_SIDED|95.0|-14.49|15.16|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||15.16|-14.49|
71735617|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.8|||||TWO_SIDED|95.0|-13.13|16.74|||||Non-responder imputation was used to handle dropouts.|Week 4 analysis presented in this section for comparison to prednisone 10 mg.||16.74|-13.13|
71735618|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-19.51|||||TWO_SIDED|95.0|-32.19|-6.84|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||-6.84|-32.19|
71735619|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.97|||||TWO_SIDED|95.0|-24.24|6.29|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||6.29|-24.24|
71735620|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-8.4|||||TWO_SIDED|95.0|-23.92|7.1|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||7.10|-23.92|
71735621|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.71|||||TWO_SIDED|95.0|-20.76|11.32|||||Non-responder imputation was used to handle dropouts.|Week 6 analysis presented in this section for comparison to prednisone 10 mg.||11.32|-20.76|
71735622|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-17.19|||||TWO_SIDED|95.0|-32.36|-2.02|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||-2.02|-32.36|
71735623|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-9.06|||||TWO_SIDED|95.0|-25.69|7.56|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||7.56|-25.69|
71735624|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|0.57|||||TWO_SIDED|95.0|-17.53|18.68|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||18.68|-17.53|
71735625|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.81|||||TWO_SIDED|95.0|-22.07|12.45|||||Non-responder imputation was used to handle dropouts.|Week 8 analysis presented in this section for comparison to prednisone 10 mg.||12.45|-22.07|
71735626|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
71735627|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.89|||||TWO_SIDED|95.0|-11.21|15.0|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||15.00|-11.21|
71773733|NCT01442038|143047567|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.4|TWO_SIDED|95.0|0.244|1.691||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.691|0.244|0.40
71773734|NCT01442038|143047568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.82|TWO_SIDED|95.0|0.579|1.994||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.994|0.579|0.82
71773735|NCT01442038|143047569|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.968||||0.81|TWO_SIDED|95.0|0.745|1.256||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model|||||1.256|0.745|0.81
71773736|NCT02128828|143047587|SUPERIORITY|||||||0.0079|||||||Wilcoxon (Mann-Whitney)|||||||0.0079
71832655|NCT02409667|143169456|NON_INFERIORITY|The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.|Odds Ratio (OR)|1.91||||0.1499|TWO_SIDED|95.0|1.44|2.55|||Regression, Logistic|||||2.55|1.44|0.1499
71832656|NCT02409667|143169457|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1013|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|||||1.10|0.35|0.1013
71832657|NCT02409667|143169460|SUPERIORITY||Least square mean (LSM) estimate|-0.09||||0.0489|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA|||Week 28||-0.00|-0.18|0.0489
71832658|NCT02409667|143169460|SUPERIORITY||LSM estimate|-0.09||||0.1073|TWO_SIDED|95.0|-0.19|0.02|||ANCOVA|||Week 32||0.02|-0.19|0.1073
71832659|NCT02409667|143169460|SUPERIORITY||LSM estimate|-0.24||||0.0001|TWO_SIDED|95.0|-0.37|-0.12|||ANCOVA|||Week 36||-0.12|-0.37|0.0001
71832660|NCT02409667|143169460|SUPERIORITY||LSM estimate|-0.25||||0.0005|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Week 40||-0.11|-0.38|0.0005
71832661|NCT02409667|143169460|SUPERIORITY||LSM estimate|-0.3||||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||ANCOVA|||Week 44||-0.15|-0.45|0.0001
71832662|NCT02409667|143169460|SUPERIORITY||LSM estimate|-0.49||||0|TWO_SIDED|95.0|-0.7|-0.27|||ANCOVA|||Week 48||-0.27|-0.70|0.0000
71832663|NCT02409667|143169460|SUPERIORITY||LSM mean|-0.59||||0|TWO_SIDED|95.0|-0.81|-0.36|||ANCOVA|||||-0.36|-0.81|0.0000
71832664|NCT02409667|143169461|SUPERIORITY||LSM estimate|0.4||||0.174|TWO_SIDED|95.0|-0.18|0.99|||ANCOVA|||Week 28||0.99|-0.18|0.1740
71832665|NCT02409667|143169461|SUPERIORITY||LSM estimate|0.79||||0.0287|TWO_SIDED|95.0|0.08|1.5|||ANCOVA|||Week 32||1.50|0.08|0.0287
71889893|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|63.0||||0.003|ONE_SIDED|97.5|46.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||46.7|0.003
71889894|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|81.5|||<|0.001|ONE_SIDED|97.5|60.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||60.9|<0.001
71889895|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|49.3||||0.53|ONE_SIDED|97.5|-9.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||-9.0|0.53
71832666|NCT02409667|143169461|SUPERIORITY||LSM estimate|0.62||||0.1202|TWO_SIDED|95.0|-0.16|1.41|||ANCOVA|||Week 36||1.41|-0.16|0.1202
71832667|NCT02409667|143169461|SUPERIORITY||LSM estimate|0.75||||0.1157|TWO_SIDED|95.0|-0.19|1.68|||ANCOVA|||Week 40||1.68|-0.19|0.1157
71832668|NCT02409667|143169461|SUPERIORITY||LSM estimate|0.54||||0.3189|TWO_SIDED|95.0|-0.52|1.59|||ANCOVA|||Week 44||1.59|-0.52|0.3189
71832669|NCT02409667|143169461|SUPERIORITY||LSM estimate|1.17||||0.024|TWO_SIDED|95.0|0.16|2.18|||ANCOVA|||Week 48||2.18|0.16|0.0240
71735628|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-15.77|7.37|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||7.37|-15.77|
71832670|NCT02409667|143169461|SUPERIORITY||LSM estimate|1.47||||0.009|TWO_SIDED|95.0|0.37|2.57|||ANCOVA|||Week 52||2.57|0.37|0.0090
71832671|NCT02409667|143169462|SUPERIORITY||LSM estimate|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||ANCOVA|||||-0.31|-0.93|0.0001
71832672|NCT02409667|143169463|SUPERIORITY||LSM estimate|1.17||||0.0675|TWO_SIDED|95.0|-0.09|2.42|||ANCOVA|||||2.42|-0.09|0.0675
71832673|NCT02409667|143169464|SUPERIORITY||LSM estimate|-0.97||||0.2101|TWO_SIDED|95.0|-2.48|0.55|||ANCOVA|||Absenteeism||0.55|-2.48|0.2101
71832674|NCT02409667|143169464|SUPERIORITY||LSM estimate|-0.67||||0.2971|TWO_SIDED|95.0|-1.93|0.59|||ANCOVA|||Presenteeism||0.59|-1.93|0.2971
71832675|NCT02409667|143169464|SUPERIORITY||LSM estimate|-0.61||||0.5499|TWO_SIDED|95.0|-2.59|1.38|||ANCOVA|||Total activity impairment||1.38|-2.59|0.5499
71832676|NCT02409667|143169464|SUPERIORITY||LSM estimate|-1.08||||0.0758|TWO_SIDED|95.0|-2.28|0.11|||ANCOVA|||||0.11|-2.28|0.0758
71832677|NCT02409667|143169465|SUPERIORITY||LSM estimate|1.2||||0.4156|TWO_SIDED|95.0|-1.71|4.11|||ANCOVA|||Absenteeism||4.11|-1.71|0.4156
71832678|NCT02409667|143169465|SUPERIORITY||LSM estimate|0.63||||0.8619|TWO_SIDED|95.0|-6.59|7.85|||ANCOVA|||Presenteeism||7.85|-6.59|0.8619
71832679|NCT02409667|143169465|SUPERIORITY||LSM estimate|-0.61||||0.6139|TWO_SIDED|95.0|-6.31|10.61|||ANCOVA|||Total activity impairment||10.61|-6.31|0.6139
71832680|NCT02409667|143169465|SUPERIORITY||LSM estimate|1.7||||0.5674|TWO_SIDED|95.0|-4.16|7.56|||ANCOVA|||Work productivity loss||7.56|-4.16|0.5674
71832681|NCT02409667|143169466|SUPERIORITY||LSM estimate|-0.13||||0.1219|TWO_SIDED|95.0|-0.3|0.04|||ANCOVA|||Pain||0.04|-0.30|0.1219
71832682|NCT02409667|143169466|SUPERIORITY||LSM estimate|-0.38||||0.0001|TWO_SIDED|95.0|-0.57|-0.18|||ANCOVA|||Itching||-0.18|-0.57|0.0001
71832683|NCT02409667|143169466|SUPERIORITY||LSM estimate|-0.31||||0.0003|TWO_SIDED|95.0|-0.48|-0.14|||ANCOVA|||Scaling||-0.14|-0.48|0.0003
71832684|NCT02409667|143169467|SUPERIORITY||LSM estimate|0.17||||0.6457|TWO_SIDED|95.0|-0.57|0.92|||ANCOVA|||Pain||0.92|-0.57|0.6457
71832685|NCT02409667|143169467|SUPERIORITY||LSM estimate|0.19||||0.6136|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Itching||0.94|-0.56|0.6136
71832686|NCT02409667|143169467|SUPERIORITY||LSM estimate|0.75||||0.0203|TWO_SIDED|95.0|0.12|1.39|||ANCOVA|||Scaling||1.39|0.12|0.0203
71832687|NCT02409667|143169468|SUPERIORITY||LSM estimate|2.22||||0.0027|TWO_SIDED|95.0|0.77|3.68|||ANCOVA|||||3.68|0.77|0.0027
71735629|NCT01393639|142985832|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-2.35|||||TWO_SIDED|95.0|-14.38|9.66|||||Non-responder imputation was used to handle dropouts.|Week 12 analysis presented in this section for comparison to prednisone 10 mg.||9.66|-14.38|
71832688|NCT02409667|143169469|SUPERIORITY||LSM estimate|-2.31||||0.2823|TWO_SIDED|95.0|-6.55|1.92|||ANCOVA|||||1.92|-6.55|0.2823
71832689|NCT02409667|143169470|SUPERIORITY||LSM estimate|0.01||||0.0861|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|||Germany||0.02|-0.00|0.0861
71735630|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.13|||||TWO_SIDED|95.0|-4.19|-0.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.07|-4.19|
71735631|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.6|||||TWO_SIDED|95.0|-5.63|-1.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.57|-5.63|
71735632|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-5.06|-0.97||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.97|-5.06|
71735633|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-5.73|-1.68||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-5.73|
71735634|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.93|||||TWO_SIDED|95.0|-3.97|0.12||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.12|-3.97|
71735635|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.43|||||TWO_SIDED|95.0|-5.46|-1.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.39|-5.46|
71735636|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-4.03|0.42||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-4.03|
71735637|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-5.04|-0.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-5.04|
71832690|NCT02409667|143169470|SUPERIORITY||LSM estimate|0.02||||0.0117|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|||UK||0.04|0.00|0.0117
71735638|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85|||||TWO_SIDED|95.0|-5.07|-0.64||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.64|-5.07|
71735639|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.77|||||TWO_SIDED|95.0|-4.98|-0.56||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.56|-4.98|
71735640|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.63|||||TWO_SIDED|95.0|-3.85|0.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.59|-3.85|
71735641|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.27|||||TWO_SIDED|95.0|-5.48|-1.06||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.06|-5.48|
71773737|NCT03228420|143047588|SUPERIORITY||||||<|0.001||||||2-sided alpha level of 0.05|Fisher Exact|||||||<0.001
71773738|NCT01841736|143047599|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0005|TWO_SIDED|80.0|0.42|0.69|||Log Rank|Stratified log rank||||0.69|0.42|0.0005
71773739|NCT01841736|143047601|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7|TWO_SIDED|80.0|0.84|1.51|||Log Rank|Stratified Log-Rank||||1.51|0.84|0.7
71773740|NCT03646643|143047607|SUPERIORITY||Hazard Ratio (HR)|0.12||||0.047|TWO_SIDED|95.0|0.02|0.97||A priori threshold \<0.05. Multiple comparisons adjustments: not needed.|Log Rank||The distal CS to LA connection elimination group had fewer recurrences (6.7%) compared with the standard group (46.7%), which translated to an 88% lower hazard of recurrence compared with the standard group.|Power calculation: assuming alpha 0.05, power 0.8, 1:1 randomization, and estimated relative risk of 14.4 for AF susceptibility with rate-dependent CS-LA conduction block, we anticipated a minimum sample size of 6 patients per group would be necessary to detect a difference using the log-rank test. Additional patients were recruited to account for potential losses to follow-up and a smaller detectable difference.||0.97|0.02|0.047
71832691|NCT02409667|143169471|SUPERIORITY||LSM estimate|-0.02||||0.1852|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Germany||0.01|-0.05|0.1852
71832692|NCT02409667|143169471|SUPERIORITY||LSM estimate|-0.03||||0.2203|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||UK||0.02|-0.07|0.2203
71832693|NCT00774852|143169493|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.85
71832694|NCT00774852|143169494|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.99
71832695|NCT00774852|143169495|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
71660211|NCT04135196|142834775|OTHER|||||||||||||||||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain magnitude. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|"At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.~At 9 months, there was a significant overall linear relationship between change in BV/TV and strain magnitude group. Additionally, the coefficient representing the contrast between the control group and the low strain magnitude group was also significant. All other comparisons were not statistically significant (p\>0.05).~Stats for 9 months:~Overall model fit: R\^2=0.240, F=5.057, df1=2, df2=32, p=0.012~Contrast between the low strain magnitude group and the control group: B=0.003, Std. Error of estimate of B=0.001, Beta=0.562, t=3.180, p=0.003, 95% CI of B: \[0.001, 0.006\]"|||
71660212|NCT04135196|142834775|OTHER||||||>|0.05|||||||Regression, Linear|||The null hypothesis was that change in bone volume fraction (BV/TV) was not proportional to strain rate. At each time point, raw change relative to baseline was analyzed as the dependent variable in a linear regression model with coefficients representing contrasts between the two experimental groups and the control group.|At each time point, the overall fit of the linear regression model was assessed with an F-test of overall significance. Additionally, the significance of each coefficient representing contrasts between each experimental group and the control group was assessed using t-tests.|||>0.05
71660213|NCT01753336|142834778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|STANDARD_DEVIATION|8.94|||TWO_SIDED|95.0|-9.79|-6.28||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.||-6.28|-9.79|
71660214|NCT01753336|142834778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|11.68|||TWO_SIDED|95.0|-7.36|-2.68||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.||-2.68|-7.36|
71660215|NCT01753336|142834778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|STANDARD_DEVIATION|7.29|||TWO_SIDED|95.0|-7.42|-4.47||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.||-4.47|-7.42|
71660216|NCT01753336|142834778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|7.49|||TWO_SIDED|95.0|-3.37|-0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.||-0.27|-3.37|
71660217|NCT01753336|142834778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_DEVIATION|9.03|||TWO_SIDED|95.0|-5.99|-2.2||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-2.20|-5.99|
71660218|NCT01753336|142834778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_DEVIATION|9.42|||TWO_SIDED|95.0|-3.11|0.81||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.81|-3.11|
71660219|NCT01753336|142834779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|9.74|||TWO_SIDED|95.0|-13.38|-9.56||||||Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.||-9.56|-13.38|
71735642|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.23|||||TWO_SIDED|95.0|-4.66|0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.20|-4.66|
71660220|NCT01753336|142834779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|STANDARD_DEVIATION|10.89|||TWO_SIDED|95.0|-11.08|-6.71||||||Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.||-6.71|-11.08|
71735643|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-6.62|-1.77||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.77|-6.62|
71735644|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.73|||||TWO_SIDED|95.0|-6.15|-1.31||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.31|-6.15|
71735645|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.09|-1.26||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.26|-6.09|
71832696|NCT00774852|143169495|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.72
71832697|NCT00774852|143169496|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-square test||||||0.54
71832698|NCT00774852|143169501|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
71832699|NCT00774852|143169502|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Two-sided Pearson's chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.||||>0.99
71832700|NCT00774852|143169504|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.23
71735646|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-4.69|0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-4.69|
71735647|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.11|||||TWO_SIDED|95.0|-6.52|-1.7||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.70|-6.52|
71735648|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.34|-0.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-5.34|
71773741|NCT04131556|143047608|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least square means|67.76|||||TWO_SIDED|90.0|59.5|77.16|||ANOVA|||||77.16|59.50|
71773742|NCT04131556|143047608|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|62.29|||||TWO_SIDED|90.0|54.73|70.9|||ANOVA|||||70.90|54.73|
71735649|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-6.93|-1.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.83|-6.93|
71832701|NCT00774852|143169504|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with renal flare||||0.61
71735650|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|||||TWO_SIDED|95.0|-7.74|-2.66||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.66|-7.74|
71735651|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|||||TWO_SIDED|95.0|-7.43|-2.36||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.36|-7.43|
71735652|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74|||||TWO_SIDED|95.0|-5.28|-0.2||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-5.28|
71735653|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.57|||||TWO_SIDED|95.0|-7.1|-2.05||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.05|-7.10|
71735654|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.73|3.33||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.33|-0.73|
71735655|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-2.18|1.84||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.84|-2.18|
71735656|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|-1.61|2.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.44|-1.61|
71735657|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-2.27|1.73||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.73|-2.27|
71735658|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.47|||||TWO_SIDED|95.0|-0.74|3.68||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.68|-0.74|
71735659|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.76|2.65||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.65|-1.76|
71735660|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-1.79|2.63||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.63|-1.79|
71735661|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|-1.69|2.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.70|-1.69|
71735662|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.53|4.29||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-0.53|
71735663|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-2.5|2.33||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.33|-2.50|
71773743|NCT04131556|143047609|OTHER||Median Difference (Final Values)|1.25|||<|0.001|TWO_SIDED|90.0|0.75|1.75|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.75|0.75|<.001
71735664|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-2.03|2.79||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.79|-2.03|
71773744|NCT04131556|143047609|OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|90.0|0.75|1.25|||Wilcoxon signed rank test|||Statistical analysis of tmax was performed using a nonparametric test. The median difference of tmax between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||1.25|0.75|<.001
71832702|NCT00774852|143169504|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
71832703|NCT00774852|143169504|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups with at least one non-renal flare||||>0.99
71735665|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.97|2.84||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.84|-1.97|
71735666|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.78|||||TWO_SIDED|95.0|-0.75|4.3||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.75|
71735667|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-2.34|2.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.73|-2.34|
71735668|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|95.0|-3.14|1.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.89|-3.14|
71735669|NCT01393639|142985833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|||||TWO_SIDED|95.0|-2.84|2.19||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.19|-2.84|
71735670|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.91|0.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-2.91|
71735671|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.45|||||TWO_SIDED|95.0|-4.17|-0.73||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-4.17|
71735672|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-3.76|-0.29||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.29|-3.76|
71735673|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.11|||||TWO_SIDED|95.0|-4.82|-1.4||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.40|-4.82|
71660221|NCT01753336|142834779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.4|STANDARD_DEVIATION|11.43|||TWO_SIDED|95.0|-16.74|-12.11||||||Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.||-12.11|-16.74|
71773745|NCT04131556|143047610|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|81.27|||||TWO_SIDED|90.0|73.88|89.4|||ANOVA|||||89.40|73.88|
71735674|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-3.13|0.33||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-3.13|
71735675|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-4.52|-1.07||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.07|-4.52|
71735676|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.67|||||TWO_SIDED|95.0|-3.63|0.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.29|-3.63|
71735677|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|||||TWO_SIDED|95.0|-3.94|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-3.94|
71735678|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07|||||TWO_SIDED|95.0|-4.03|-0.11||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-4.03|
71735679|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-5.09|-1.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.09|
71832704|NCT00774852|143169509|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.79
71660222|NCT01753336|142834779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|STANDARD_DEVIATION|11.33|||TWO_SIDED|95.0|-12.92|-8.22||||||Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.||-8.22|-12.92|
71735680|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-3.85|0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-3.85|
71735681|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.84|||||TWO_SIDED|95.0|-4.79|-0.88||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.88|-4.79|
71735682|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.32|||||TWO_SIDED|95.0|-3.25|0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-3.25|
71735683|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97|||||TWO_SIDED|95.0|-3.9|-0.04||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-3.90|
71735684|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-4.35|-0.5||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.50|-4.35|
71735685|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.75|||||TWO_SIDED|95.0|-4.66|-0.83||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.83|-4.66|
71735686|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.88|-0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-3.88|
71735687|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.08|||||TWO_SIDED|95.0|-5.0|-1.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.17|-5.00|
71735688|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.99|||||TWO_SIDED|95.0|-4.2|0.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-4.20|
71773746|NCT04131556|143047610|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|78.0|||||TWO_SIDED|90.0|70.92|85.79|||ANOVA|||||85.79|70.92|
71832705|NCT00774852|143169509|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA|||||||0.74
71735689|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.95|||||TWO_SIDED|95.0|-5.17|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-5.17|
71735690|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.44|||||TWO_SIDED|95.0|-5.65|-1.23||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.23|-5.65|
71735691|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.32|||||TWO_SIDED|95.0|-5.52|-1.12||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.12|-5.52|
71832706|NCT00774852|143169510|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Pneumococcal vaccines||||0.43
71773747|NCT04131556|143047611|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|83.52|||||TWO_SIDED|90.0|76.12|91.64|||ANOVA|||||91.64|76.12|
71832707|NCT00774852|143169510|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|Pearson's||Comparison of groups for Tetanus Toxoid vaccines||||0.99
71832708|NCT04870645|143169526|OTHER||||||<|0.05|||||||Statistical Significance|||||||< 0.05
71660223|NCT01753336|142834779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|STANDARD_DEVIATION|12.19|||TWO_SIDED|95.0|-17.18|-12.1||||||Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.||-12.10|-17.18|
71735692|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-4.6|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-4.60|
71735693|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.87|||||TWO_SIDED|95.0|-6.07|-1.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-6.07|
71735694|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.62|||||TWO_SIDED|95.0|-0.1|3.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.34|-0.10|
71735695|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.36|2.05||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-1.36|
71735696|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|||||TWO_SIDED|95.0|-0.94|2.48||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.48|-0.94|
71735697|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-2.01|1.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.38|-2.01|
71735698|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.17|||||TWO_SIDED|95.0|-0.79|3.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.12|-0.79|
71773748|NCT04131556|143047611|EQUIVALENCE|Equivalence analysis based on confidence intervals (CIs). If the 90% CIs of the geometric mean ratios were within (0.8, 1.25), bioequivalence between the two formulations (test powder for oral suspension versus reference tablet) was to be claimed. A linear mixed effect ANOVA model with treatment, period, sequence as fixed effects and participant within sequence as a random effect was used to fit to ln-transformed PK parameters.|% Ratio of Geometric least squares means|80.36|||||TWO_SIDED|90.0|73.26|88.16|||ANOVA|||||88.16|73.26|
71773749|NCT04131556|143047614|OTHER||Median Difference (Final Values)|0.13||||0.006|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.006
71832709|NCT03237481|143169546|SUPERIORITY||Least Squares Mean Difference (LSMD)|-81.43|STANDARD_ERROR_OF_MEAN|22.592|=|0.0004|TWO_SIDED|95.0|-125.83|-37.02|||ANOVA|||||-37.02|-125.83|= 0.0004
71832710|NCT03237481|143169547|SUPERIORITY||Least Squares Mean Difference (LSMD)|-72.49|STANDARD_ERROR_OF_MEAN|18.23|<|0.0001|TWO_SIDED|95.0|-108.32|-36.65|||ANOVA|||||-36.65|-108.32|< 0.0001
71832711|NCT03237481|143169548|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0001
71832712|NCT03237481|143169549|SUPERIORITY||Risk Difference (RD)|0.111|||=|0.0486|TWO_SIDED|95.0|0.003|0.218|||Fisher Exact|||||0.218|0.003|= 0.0486
71735699|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-1.1|2.82||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.82|-1.10|
71832713|NCT03237481|143169550|SUPERIORITY||||||=|0.024|||||||Wilcoxon (Mann-Whitney)|||||||= 0.024
71735700|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-1.19|2.72||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.72|-1.19|
71735701|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.24|1.66||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.66|-2.24|
71735702|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.76|||||TWO_SIDED|95.0|-0.16|3.67||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.67|-0.16|
71735703|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12|||||TWO_SIDED|95.0|-0.81|3.04||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.04|-0.81|
71735704|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.26|2.57||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.57|-1.26|
71735705|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.57|2.25||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.25|-1.57|
71735706|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.88|||||TWO_SIDED|95.0|-0.31|4.07||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.07|-0.31|
71735707|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|||||TWO_SIDED|95.0|-1.28|3.13||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.13|-1.28|
71735708|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|||||TWO_SIDED|95.0|-1.76|2.62||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-1.76|
71735709|NCT01393639|142985835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-1.63|2.74||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.74|-1.63|
71735710|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.49|||||TWO_SIDED|95.0|-12.52|3.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.55|-12.52|
71735711|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.15|||||TWO_SIDED|95.0|-18.1|-2.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.20|-18.10|
71735712|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.93|||||TWO_SIDED|95.0|-18.94|-2.92||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.92|-18.94|
71735713|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.12|||||TWO_SIDED|95.0|-24.01|-8.24||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.24|-24.01|
71773750|NCT04131556|143047614|OTHER||Median Difference (Final Values)|0.13||||0.011|TWO_SIDED|90.0|0.13|0.25|||Wilcoxon signed rank test|||Statistical analysis of Tlag was performed using a nonparametric test. The median difference of Tlag between treatments and 90% CIs of the median differences were calculated from Hodges-Lehman estimate, and p-value was produced from Wilcoxon signed rank test.||0.25|0.13|0.011
71773751|NCT00559754|143047680|SUPERIORITY_OR_OTHER|||||||0.4915|||||||Fisher Exact|||||||0.4915
71773752|NCT00559754|143047681|SUPERIORITY_OR_OTHER|||||||0.4864|||||||Chi-squared|||||||0.4864
71735714|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-13.45|2.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.56|-13.45|
71735715|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.09|-6.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.11|-22.09|
71735716|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.42|||||TWO_SIDED|95.0|-11.13|4.29||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.29|-11.13|
71735717|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.98|||||TWO_SIDED|95.0|-15.7|-0.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.26|-15.70|
71735718|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.17|||||TWO_SIDED|95.0|-12.93|2.59||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.59|-12.93|
71735719|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.22|||||TWO_SIDED|95.0|-17.9|-2.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.54|-17.90|
71773753|NCT00559754|143047682|SUPERIORITY_OR_OTHER|||||||0.3613|||||||Fisher Exact|||||||0.3613
71773754|NCT00559754|143047683|SUPERIORITY_OR_OTHER|||||||0.6605|||||||Fisher Exact|||||||0.6605
71773755|NCT00559754|143047684|SUPERIORITY_OR_OTHER|||||||0.8311|||||||Fisher Exact|||||||0.8311
71773756|NCT00559754|143047685|SUPERIORITY_OR_OTHER|||||||0.223|||||||Fisher Exact|||||||0.2230
71773757|NCT00559754|143047686|SUPERIORITY_OR_OTHER|||||||0.8696|||||||Fisher Exact|||||||0.8696
71660224|NCT01753336|142834779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.7|STANDARD_DEVIATION|11.17|||TWO_SIDED|95.0|-14.02|-9.39||||||Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.||-9.39|-14.02|
71660225|NCT01753336|142834781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.95|||TWO_SIDED|95.0|-4.46|-2.52||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.52|-4.46|
71660226|NCT01753336|142834781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|5.24|||TWO_SIDED|95.0|-2.81|-0.7||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.70|-2.81|
71660227|NCT01753336|142834781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.77|||TWO_SIDED|95.0|-3.75|-2.23||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-2.23|-3.75|
71660228|NCT01753336|142834781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-1.33|0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.27|-1.33|
71660229|NCT01753336|142834781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_DEVIATION|4.32|||TWO_SIDED|95.0|-3.64|-1.83||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||-1.83|-3.64|
71660230|NCT01753336|142834781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|4.77|||TWO_SIDED|95.0|-2.0|-0.02||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||-0.02|-2.00|
71660231|NCT01753336|142834782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_DEVIATION|3.86|||TWO_SIDED|95.0|-3.64|-2.12||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-2.12|-3.64|
71660232|NCT01753336|142834782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|4.82|||TWO_SIDED|95.0|-2.79|-0.86||||||Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.86|-2.79|
71660233|NCT01753336|142834782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.47|||TWO_SIDED|95.0|-2.44|-1.04||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-1.04|-2.44|
71660234|NCT01753336|142834782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.46|||TWO_SIDED|95.0|-1.55|-0.12||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||-0.12|-1.55|
71660235|NCT01753336|142834782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|3.75|||TWO_SIDED|95.0|-1.45|0.12||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.12|-1.45|
71773758|NCT00559754|143047687|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Fisher Exact|||||||0.0074
71660236|NCT01753336|142834782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.73|||TWO_SIDED|95.0|-0.85|0.7||||||Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.70|-0.85|
71660237|NCT01753336|142834783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|3.74|||TWO_SIDED|95.0|-2.39|-0.92||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.||-0.92|-2.39|
71660238|NCT01753336|142834783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_DEVIATION|3.88|||TWO_SIDED|95.0|-2.22|-0.66||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.||-0.66|-2.22|
71660239|NCT01753336|142834783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|3.12|||TWO_SIDED|95.0|-1.84|-0.58||||||Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.||-0.58|-1.84|
71773759|NCT00559754|143047688|SUPERIORITY_OR_OTHER|||||||0.3235|||||||Fisher Exact|||||||0.3235
71773760|NCT00559754|143047689|SUPERIORITY_OR_OTHER|||||||0.0693|||||||Fisher Exact|||||||0.0693
71773761|NCT00559754|143047691|SUPERIORITY_OR_OTHER|||||||0.4254|||||||Fisher Exact|||||||0.4254
71773762|NCT00559754|143047693|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71773763|NCT00559754|143047694|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71773764|NCT00559754|143047696|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71773765|NCT00573248|143047749|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
71773766|NCT00573248|143047750|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED||||||ANOVA|||2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA||||<0.025
71773767|NCT00573248|143047751|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
71773768|NCT00573248|143047752|SUPERIORITY_OR_OTHER||||||<|0.025|ONE_SIDED|||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item||||<0.025
71660240|NCT01753336|142834783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|3.04|||TWO_SIDED|95.0|-1.08|0.18||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.||0.18|-1.08|
71735720|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.43|||||TWO_SIDED|95.0|-5.32|10.19||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.19|-5.32|
71735721|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.14|||||TWO_SIDED|95.0|-18.83|-3.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.45|-18.83|
71773769|NCT05323656|143047804|SUPERIORITY||LS Mean Difference|5.05|STANDARD_ERROR_OF_MEAN|13.077||0.7008|TWO_SIDED|80.0|-11.98|22.0|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group|Null hypothesis: the mean best percentage change in the tumour size between the treatment groups are the same. With 25 patients per treatment group, using a 2-sided t-test, there will be 85% power to detect a 20% mean difference between the treatment groups in best percentage change in tumour size, with an estimated standard deviation of 30% and a 2 sided alpha of 20%.||22.0|-11.98|0.7008
71773770|NCT05323656|143047805|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.1023|TWO_SIDED|80.0|0.38|0.89|||Regression, Cox|||Null hypothesis: The risk for progression, as defined by RECIST v1.1, is the same between treatment groups. If the true hazard ratio is 0.5, approximately 38 progression events as defined by RECIST v1.1 will be required to have \> 80% power to demonstrate a statistically significant difference in PFS with 2-sided p\<0.2||0.89|0.38|.1023
71773771|NCT05323656|143047806|SUPERIORITY||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|8.89||0.2986|TWO_SIDED|80.0|-2.3|21.3||a priori threshold for significance (0.2) not met.|ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CAF levels does not differ between treatment groups. ANCOVA model is on postbaseline CAFs level with a fixed factor for treatment and a covariate for baseline.||21.3|-2.3|0.2986
71773772|NCT05323656|143047807|SUPERIORITY||LS Mean Difference|6.83|STANDARD_ERROR_OF_MEAN|12.48||0.5918|TWO_SIDED|80.0|-9.86|23.52|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline CD8+ TILs does not differ between treatment groups. ANCOVA model is on postbaseline CD8+ TILs level with a fixed factor for treatment and a covariate for baseline.||23.52|-9.86|0.5918
71773773|NCT05323656|143047808|SUPERIORITY||LS Mean Difference|10.84|STANDARD_ERROR_OF_MEAN|8.37||0.2135|TWO_SIDED|80.0|-0.34|22.02|||ANCOVA||The LS Mean difference is for the Setanaxib Group minus the Placebo Group.|Null Hypothesis: Mean difference in postbaseline number of regulatory T-cells in tumour tissue does not differ between treatment groups. ANCOVA model is on postbaseline number of regulatory T-cells in tumour tissue level with a fixed factor for treatment and a covariate for baseline.||22.02|-0.34|0.2135
71773774|NCT05323656|143047812|SUPERIORITY||Hazard Ratio (HR)|0.448|||||TWO_SIDED|80.0|0.24|0.85||||||No formal test of significance undertaken.||0.85|0.24|
71660241|NCT01753336|142834783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-1.57|0.19||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.||0.19|-1.57|
71735722|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.42|||||TWO_SIDED|95.0|-12.44|1.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.59|-12.44|
71735723|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.24|||||TWO_SIDED|95.0|-19.27|-5.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.20|-19.27|
71773775|NCT05323656|143047815|SUPERIORITY||Mean Difference (Final Values)|17.76|STANDARD_ERROR_OF_MEAN|9.4||0.0782|TWO_SIDED|80.0|5.17|30.36|||ANCOVA|The LS Mean difference is for the Setanaxib Group minus the Placebo Group.||Null Hypothesis: Mean difference in postbaseline PD-L1 combined positive score (CPS) does not differ between treatment groups. ANCOVA model is on postbaseline PD-L1 CPS with a fixed factor for treatment and a covariate for baseline. Threshold for statistical significance = 0.2.||30.36|5.17|0.0782
71773776|NCT05323656|143047816|OTHER||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.578||0.22|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.22
71773777|NCT05323656|143047816|OTHER||Mean Difference (Net)|-0.18|STANDARD_DEVIATION|0.395||0.2|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.20
71773778|NCT05323656|143047817|OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.069||0.037|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.037
71773779|NCT05323656|143047817|OTHER||Mean Difference (Net)|-0.02|STANDARD_DEVIATION|0.039||0.123|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.123
71773780|NCT05323656|143047818|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.017||0.41|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.41
71735724|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.13|||||TWO_SIDED|95.0|-16.11|-2.14||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.14|-16.11|
71735725|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.88|||||TWO_SIDED|95.0|-16.89|-2.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.88|-16.89|
71735726|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.61|||||TWO_SIDED|95.0|-9.63|4.4||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.40|-9.63|
71735727|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.93|||||TWO_SIDED|95.0|-19.88|-5.98||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.98|-19.88|
71735728|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-10.03|3.83||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.83|-10.03|
71735729|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-17.06|-3.13||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.13|-17.06|
71735730|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.67|||||TWO_SIDED|95.0|-17.57|-3.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.77|-17.57|
71735731|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.79|||||TWO_SIDED|95.0|-14.72|-0.86||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.86|-14.72|
71735732|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.05|||||TWO_SIDED|95.0|-9.98|3.89||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-9.98|
71832714|NCT02980276|143169567|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.9||||0.13|TWO_SIDED|95.0|-15.1|1.4||The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.|Risk difference||Units are %|The primary analysis, as per sample size calculation, was a two-sample comparison of reduction in the proportion of women needing insulin between treatment and control arms using an exact test for a binomial response.||1.4|-15.1|0.13
71832715|NCT02980276|143169568|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-12.7||||0.004|TWO_SIDED|95.0|-21.2|-4.3|||Risk difference||Units are %|||-4.3|-21.2|0.004
71735733|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.27|-6.54||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.54|-20.27|
71735734|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.61|||||TWO_SIDED|95.0|1.62|17.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.61|1.62|
71735735|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-3.96|11.85||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.85|-3.96|
71735736|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.17|||||TWO_SIDED|95.0|-4.8|11.13||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.13|-4.80|
71735737|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.03|||||TWO_SIDED|95.0|-9.86|5.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.81|-9.86|
71735738|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.72|||||TWO_SIDED|95.0|0.03|15.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.42|0.03|
71735739|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.16|||||TWO_SIDED|95.0|-4.54|10.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.87|-4.54|
71660242|NCT01753336|142834783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|3.78|||TWO_SIDED|95.0|-0.85|0.73||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.||0.73|-0.85|
71735740|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.97|||||TWO_SIDED|95.0|-1.77|13.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.71|-1.77|
71735741|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-6.75|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-6.75|
71735742|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.57|14.43||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.43|0.57|
71735743|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|||||TWO_SIDED|95.0|-6.26|7.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.64|-6.26|
71735744|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-3.09|10.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.70|-3.09|
71735745|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|||||TWO_SIDED|95.0|-3.87|9.96||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.96|-3.87|
71735746|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.31|||||TWO_SIDED|95.0|3.43|17.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.18|3.43|
71735747|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.31|||||TWO_SIDED|95.0|-3.59|10.22||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.22|-3.59|
71735748|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.73|||||TWO_SIDED|95.0|-4.1|9.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.57|-4.10|
71832716|NCT02980276|143169569|SUPERIORITY|||||||0.001|||||||Log Rank|Median survival times could not be calculated; time to insulin initiation would be censored at delivery in \>50% of participants in treatment group.||||||0.001
71735749|NCT01393639|142985837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.62|||||TWO_SIDED|95.0|-1.25|12.48||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.48|-1.25|
71832717|NCT02980276|143169570|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio, log|0.61||||0.005|TWO_SIDED|95.0|0.43|0.86|||Regression, Logistic|Unadjusted|Unadjusted|||0.86|0.43|0.005
71832718|NCT02980276|143169570|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.56||||0.003|TWO_SIDED|95.0|0.38|0.82|||Regression, Logistic|Adjusted|Adjusted|||0.82|0.38|0.003
71735750|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-7.56|8.31||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.31|-7.56|
71735751|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.15|||||TWO_SIDED|95.0|-16.01|-0.3||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.30|-16.01|
71735752|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-22.01|-6.2||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.20|-22.01|
71735753|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-19.7|-4.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.06|-19.70|
71735754|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-7.33|8.48||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.48|-7.33|
71735755|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.89|||||TWO_SIDED|95.0|-20.8|-4.98||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.98|-20.80|
71735756|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-9.31|8.58||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.58|-9.31|
71735757|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.48|||||TWO_SIDED|95.0|-18.43|-0.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.53|-18.43|
71735758|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42|||||TWO_SIDED|95.0|-22.39|-4.44||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-22.39|
71735759|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.58|||||TWO_SIDED|95.0|-17.48|0.33||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.33|-17.48|
71773781|NCT05323656|143047818|OTHER||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.023||0.11|TWO_SIDED||||||Wilcoxon signed rank test|||Within group test of hypothesis that screening and week 9 values are equal.||||0.11
71773782|NCT02536833|143047825|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.575|TWO_SIDED|95.0|-6.57|3.65|||ANCOVA|||||3.65|-6.57|0.575
71773783|NCT02536833|143047825|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.643|TWO_SIDED|95.0|-6.63|4.09|||ANCOVA|||||4.09|-6.63|0.643
71773784|NCT02536833|143047825|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.901|TWO_SIDED|95.0|-5.07|5.75|||ANCOVA|||||5.75|-5.07|0.901
71773785|NCT02536833|143047826|SUPERIORITY||Mean Difference (Final Values)|-2.99||||0.271|TWO_SIDED|95.0|-8.31|2.33|||ANCOVA|||||2.33|-8.31|0.271
71773786|NCT02536833|143047826|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.898|TWO_SIDED|95.0|-6.06|5.32|||ANCOVA|||||5.32|-6.06|0.898
71773787|NCT02536833|143047826|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.795|TWO_SIDED|95.0|-4.74|6.18|||ANCOVA|||||6.18|-4.74|0.795
71773788|NCT02536833|143047827|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.283|TWO_SIDED|95.0|-7.74|2.26|||ANCOVA|||||2.26|-7.74|0.283
71773789|NCT02536833|143047827|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.588|TWO_SIDED|95.0|-6.82|3.86|||ANCOVA|||||3.86|-6.82|0.588
71773790|NCT02536833|143047827|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.853|TWO_SIDED|95.0|-5.76|4.76|||ANCOVA|||||4.76|-5.76|0.853
71773791|NCT02536833|143047828|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.292|TWO_SIDED|95.0|-8.26|2.49|||ANCOVA|||||2.49|-8.26|0.292
71660243|NCT01629966|142834820|SUPERIORITY||Least Squares Mean Difference|-1.27||||0.083|TWO_SIDED|95.0|-2.71|0.17|||MMRM|||||0.17|-2.71|0.0830
71773792|NCT02536833|143047828|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.931|TWO_SIDED|95.0|-5.34|5.83|||ANCOVA|||||5.83|-5.34|0.931
71773793|NCT02536833|143047828|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.878|TWO_SIDED|95.0|-4.92|5.76|||ANCOVA|||||5.76|-4.92|0.878
71773794|NCT02536833|143047829|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.648|TWO_SIDED|95.0|-3.83|6.16|||ANCOVA|||||6.16|-3.83|0.648
71773795|NCT02536833|143047829|SUPERIORITY||Mean Difference (Final Values)|-3.14||||0.209|TWO_SIDED|95.0|-8.02|1.75|||ANCOVA|||||1.75|-8.02|0.209
71773796|NCT02536833|143047829|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.915|TWO_SIDED|95.0|-4.78|5.33|||ANCOVA|||||5.33|-4.78|0.915
71773797|NCT02536833|143047830|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.969|TWO_SIDED|95.0|-5.16|5.36|||ANCOVA|||||5.36|-5.16|0.969
71773798|NCT02536833|143047830|SUPERIORITY||Mean Difference (Final Values)|-3.64||||0.174|TWO_SIDED|95.0|-8.89|1.61|||ANCOVA|||||1.61|-8.89|0.174
71773799|NCT02536833|143047830|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.908|TWO_SIDED|95.0|-4.97|5.59|||ANCOVA|||||5.59|-4.97|0.908
71773800|NCT02536833|143047831|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.334|TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||||0.29|-0.10|0.334
71773801|NCT02536833|143047831|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.124|TWO_SIDED|95.0|-0.04|0.3|||ANCOVA|||||0.30|-0.04|0.124
71773802|NCT02536833|143047831|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.032|TWO_SIDED|95.0|0.02|0.36|||ANCOVA|||||0.36|0.02|0.032
71773803|NCT02536833|143047832|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.405|TWO_SIDED|95.0|-8.0|3.24|||ANCOVA|||||3.24|-8.00|0.405
71773804|NCT02536833|143047832|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.552|TWO_SIDED|95.0|-4.37|8.16|||ANCOVA|||||8.16|-4.37|0.552
71773805|NCT02536833|143047832|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.763|TWO_SIDED|95.0|-4.91|6.68|||ANCOVA|||||6.68|-4.91|0.763
71773806|NCT02536833|143047833|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.173|TWO_SIDED|95.0|-9.5|1.71|||ANCOVA|||||1.71|-9.50|0.173
71773807|NCT02536833|143047833|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.724|TWO_SIDED|95.0|-5.12|7.36|||ANCOVA|||||7.36|-5.12|0.724
71773808|NCT02536833|143047833|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.914|TWO_SIDED|95.0|-6.17|5.53|||ANCOVA|||||5.53|-6.17|0.914
71735760|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-11.57|6.38||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.38|-11.57|
71735761|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.75|||||TWO_SIDED|95.0|-22.73|-4.78||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.78|-22.73|
71735762|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-9.32|8.88||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.88|-9.32|
71735763|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.28|||||TWO_SIDED|95.0|-21.39|-3.17||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.17|-21.39|
71735764|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.44|||||TWO_SIDED|95.0|-25.53|-7.36||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.36|-25.53|
71735765|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.42|-0.34||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.34|-18.42|
71735766|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.52|||||TWO_SIDED|95.0|-13.61|4.57||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.57|-13.61|
71735767|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.78|||||TWO_SIDED|95.0|-22.87|-4.69||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.69|-22.87|
71735768|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85|||||TWO_SIDED|95.0|-7.9|11.6||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.60|-7.90|
71735769|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|||||TWO_SIDED|95.0|-20.51|-0.93||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.93|-20.51|
71773809|NCT02536833|143047834|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.12|0.24|||ANCOVA|||||0.24|-0.12|0.529
71773810|NCT02536833|143047834|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.259|TWO_SIDED|95.0|-0.08|0.28|||ANCOVA|||||0.28|-0.08|0.259
71773811|NCT02536833|143047834|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.807|TWO_SIDED|95.0|-0.21|0.16|||ANCOVA|||||0.16|-0.21|0.807
71773812|NCT02536833|143047835|SUPERIORITY||Mean Difference (Final Values)|-8.73||||0.049|TWO_SIDED|95.0|-17.44|-0.03|||ANCOVA|||||-0.03|-17.44|0.049
71773813|NCT02536833|143047835|SUPERIORITY||Mean Difference (Final Values)|-6.03||||0.211|TWO_SIDED|95.0|-15.49|3.43|||ANCOVA|||||3.43|-15.49|0.211
71660244|NCT01629966|142834820|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.0156|TWO_SIDED|95.0|-3.26|-0.34|||MMRM|||||-0.34|-3.26|0.0156
71773814|NCT02536833|143047835|SUPERIORITY||Mean Difference (Final Values)|-5.23||||0.254|TWO_SIDED|95.0|-14.24|3.78|||ANCOVA|||||3.78|-14.24|0.254
71773815|NCT02536833|143047836|SUPERIORITY||Mean Difference (Final Values)|-10.26||||0.036|TWO_SIDED|95.0|-19.82|-0.69|||ANCOVA|||||-0.69|-19.82|0.036
71773816|NCT02536833|143047836|SUPERIORITY||Mean Difference (Final Values)|-7.07||||0.17|TWO_SIDED|95.0|-17.18|3.05|||ANCOVA|||||3.05|-17.18|0.170
71773817|NCT02536833|143047836|SUPERIORITY||Mean Difference (Final Values)|-6.29||||0.171|TWO_SIDED|95.0|-15.33|2.74|||ANCOVA|||||2.74|-15.33|0.171
71773818|NCT02536833|143047837|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.021|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||||0.72|0.06|0.021
71832719|NCT02980276|143169571|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.78||||0.178|TWO_SIDED|95.0|0.55|1.12|||Regression, Logistic||Unadjusted|||1.12|0.55|0.178
71832720|NCT02980276|143169571|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.72||||0.105|TWO_SIDED|95.0|0.48|1.07||Two-sided test comparing observed odds ratio to 1.|Regression, Logistic||Adjusted|||1.07|0.48|0.105
71832721|NCT02980276|143169572|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-3.7||||0.17|TWO_SIDED|95.0|-9.3|1.7|||t-test, 2 sided|||||1.7|-9.3|0.17
71832722|NCT02980276|143169573|EQUIVALENCE|Two-sided test comparing observed mean difference ratio to zero.|Mean Difference (Final Values)|-1.2||||0.003|TWO_SIDED|95.0|-1.99|-0.42|||t-test, 2 sided|||||-0.42|-1.99|0.003
71735770|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-28.28|-8.77||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.77|-28.28|
71735771|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-22.67|-3.25||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.25|-22.67|
71735772|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.46|||||TWO_SIDED|95.0|-17.21|2.3||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.30|-17.21|
71735773|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.24|||||TWO_SIDED|95.0|-26.0|-6.48||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.48|-26.00|
71735774|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.27|||||TWO_SIDED|95.0|5.34|21.2||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||21.20|5.34|
71773819|NCT02536833|143047837|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.131|TWO_SIDED|95.0|-0.07|0.55|||ANCOVA|||||0.55|-0.07|0.131
71773820|NCT02536833|143047837|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.789|TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||||0.26|-0.35|0.789
71773821|NCT05308290|143047901|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
71735775|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.74|||||TWO_SIDED|95.0|-3.12|12.59||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.59|-3.12|
71735776|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-9.1|6.68||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.68|-9.10|
71735777|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-6.79|8.81||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.81|-6.79|
71735778|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.39|||||TWO_SIDED|95.0|4.39|22.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.38|4.39|
71735779|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|||||TWO_SIDED|95.0|-4.73|13.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.27|-4.73|
71735780|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-8.68|9.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.35|-8.68|
71773822|NCT05308290|143047902|OTHER|||||||0.6||||||the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.60
71773823|NCT05308290|143047903|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
71773824|NCT05308290|143047904|OTHER|||||||1||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||1.0
71773825|NCT05308290|143047905|OTHER|||||||0.28||||||the a priori threshold for statistical significance was \<0.05|Fisher Exact|||||||0.28
71773826|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.291|STANDARD_ERROR_OF_MEAN|0.2838|||TWO_SIDED|90.0|-0.195|0.777|||mixed model repeated measures|||Week 12||0.777|-0.195|
71773827|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.282|STANDARD_ERROR_OF_MEAN|0.2843|||TWO_SIDED|90.0|-0.206|0.769|||mixed model repeated measures|||Week 12||0.769|-0.206|
71773828|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.658|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|90.0|0.017|1.299|||mixed model repeated measures|||Week 24||1.299|0.017|
71773829|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.3791|||TWO_SIDED|90.0|0.189|1.49|||mixed model repeated measures|||Week 24||1.490|0.189|
71773830|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.668|STANDARD_ERROR_OF_MEAN|0.4954|||TWO_SIDED|90.0|-0.177|1.512|||mixed model repeated measures|||Week 36||1.512|-0.177|
71773831|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.912|STANDARD_ERROR_OF_MEAN|0.4887|||TWO_SIDED|90.0|0.078|1.746|||mixed model repeated measures|||Week 36||1.746|0.078|
71773832|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|0.976|STANDARD_ERROR_OF_MEAN|0.4813|||TWO_SIDED|90.0|0.15|1.803|||mixed model repeated measures|||Week 48||1.803|0.150|
71773833|NCT04437368|143047912|SUPERIORITY||LS Mean Difference|1.233|STANDARD_ERROR_OF_MEAN|0.4573|||TWO_SIDED|90.0|0.445|2.022|||mixed model repeated measures|||Week 48||2.022|0.445|
71832723|NCT02980276|143169574|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.99|TWO_SIDED|95.0|0.65|1.55|||Regression, Logistic|||||1.55|0.65|0.99
71832724|NCT02980276|143169575|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.96||||0.911|TWO_SIDED|95.0|0.46|2.0|||Regression, Logistic|||||2|0.46|0.911
71832725|NCT02980276|143169576|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.82||||0.519|TWO_SIDED|95.0|0.44|1.51|||Regression, Logistic|||||1.51|0.44|0.519
71832726|NCT02980276|143169577|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.66|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||||0.2|-0.3|0.66
71735781|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.18|||||TWO_SIDED|95.0|-3.77|14.12||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.12|-3.77|
71735782|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.56|||||TWO_SIDED|95.0|4.44|22.68||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.68|4.44|
71735783|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-7.64|10.64||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||10.64|-7.64|
71735784|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.66|||||TWO_SIDED|95.0|-11.76|6.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.44|-11.76|
71735785|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.41|||||TWO_SIDED|95.0|-4.65|13.46||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.46|-4.65|
71735786|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.09|||||TWO_SIDED|95.0|8.34|27.84||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||27.84|8.34|
71735787|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.52|||||TWO_SIDED|95.0|-4.27|15.32||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.32|-4.27|
71735788|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.28|||||TWO_SIDED|95.0|-12.03|7.46||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.46|-12.03|
71735789|NCT01393639|142985839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.28|||||TWO_SIDED|95.0|-6.42|12.98||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.98|-6.42|
71735790|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.06|||||TWO_SIDED|95.0|-14.07|-0.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-14.07|
71735791|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.45|||||TWO_SIDED|95.0|-19.34|-5.56||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.56|-19.34|
71735792|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.85|||||TWO_SIDED|95.0|-19.79|-5.91||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.91|-19.79|
71735793|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.92|||||TWO_SIDED|95.0|-22.79|-9.06||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.06|-22.79|
71735794|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.95|||||TWO_SIDED|95.0|-10.89|2.99||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.99|-10.89|
71773834|NCT04437368|143047913|SUPERIORITY||LS Mean Difference|1.769|STANDARD_ERROR_OF_MEAN|1.2808|||TWO_SIDED|90.0|-0.441|3.979|||mixed model repeated measures|||Week 72||3.979|-0.441|
71773835|NCT04437368|143047913|SUPERIORITY||LS Mean Difference|1.274|STANDARD_ERROR_OF_MEAN|1.2349|||TWO_SIDED|90.0|-0.863|3.412|||mixed model repeated measures|||Week 72||3.412|-0.863|
71773836|NCT04437368|143047913|SUPERIORITY||LS Mean Difference|2.041|STANDARD_ERROR_OF_MEAN|1.4177|||TWO_SIDED|90.0|-0.386|4.468|||mixed model repeated measures|||Week 96||4.468|-0.386|
71735795|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-20.44|-6.57||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.57|-20.44|
71735796|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.25|||||TWO_SIDED|95.0|-14.65|0.16||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-14.65|
71735797|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.03|||||TWO_SIDED|95.0|-19.38|-4.68||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.68|-19.38|
71735798|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.72|||||TWO_SIDED|95.0|-23.1|-8.35||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.35|-23.10|
71735799|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-21.27|-6.63||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.63|-21.27|
71735800|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.94|||||TWO_SIDED|95.0|-13.31|1.43||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.43|-13.31|
71735801|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.16|||||TWO_SIDED|95.0|-23.54|-8.79||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.79|-23.54|
71735802|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.09|||||TWO_SIDED|95.0|-13.5|1.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.32|-13.50|
71735803|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.06|||||TWO_SIDED|95.0|-20.46|-5.65||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.65|-20.46|
71735804|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.31|||||TWO_SIDED|95.0|-22.69|-7.93||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.93|-22.69|
71735805|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.31|||||TWO_SIDED|95.0|-20.66|-5.96||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-5.96|-20.66|
71735806|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.06|||||TWO_SIDED|95.0|-16.44|-1.68||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.68|-16.44|
71735807|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44|||||TWO_SIDED|95.0|-21.82|-7.06||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-7.06|-21.82|
71735808|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.72|||||TWO_SIDED|95.0|-12.53|3.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.09|-12.53|
71735809|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-20.21|-4.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.59|-20.21|
71735810|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.48|||||TWO_SIDED|95.0|-24.25|-8.71||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-8.71|-24.25|
71773837|NCT04437368|143047913|SUPERIORITY||LS Mean|1.278|STANDARD_ERROR_OF_MEAN|1.3857|||TWO_SIDED|90.0|-1.099|3.655|||mixed model repeated measures|||Week 96||3.655|-1.099|
71773838|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|90.0|-10.3|8.1|||mixed model repeated measures|||Week 12||8.1|-10.3|
71773839|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-16.3|3.7|||mixed model repeated measures|||Week 12||3.7|-16.3|
71773840|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|90.0|-14.5|4.1|||mixed model repeated measures|||Week 24||4.1|-14.5|
71735811|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.19|||||TWO_SIDED|95.0|-19.94|-4.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.44|-19.94|
71735812|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.73|||||TWO_SIDED|95.0|-15.5|0.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.04|-15.50|
71735813|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.98|||||TWO_SIDED|95.0|-21.75|-6.21||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.21|-21.75|
71735814|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.45|||||TWO_SIDED|95.0|-0.53|13.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.42|-0.53|
71735815|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-5.81|7.92||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.92|-5.81|
71735816|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-6.25|7.57||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.57|-6.25|
71735817|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.42|||||TWO_SIDED|95.0|-9.26|4.42||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.42|-9.26|
71735818|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91|||||TWO_SIDED|95.0|1.48|16.35||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.35|1.48|
71735819|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.13|||||TWO_SIDED|95.0|-3.24|11.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||11.51|-3.24|
71735820|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-6.96|7.84||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.84|-6.96|
71735821|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-5.14|9.56||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.56|-5.14|
71735822|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35|||||TWO_SIDED|95.0|0.92|15.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.77|0.92|
71735823|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|-6.03|8.8||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.80|-6.03|
71735824|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-8.26|6.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.52|-8.26|
71735825|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|||||TWO_SIDED|95.0|-6.23|8.49||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.49|-6.23|
71735826|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.26|||||TWO_SIDED|95.0|1.46|17.06||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||17.06|1.46|
71735827|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.58|||||TWO_SIDED|95.0|-6.23|9.38||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.38|-6.23|
71735828|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.27|5.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.27|-10.27|
71735829|NCT01393639|142985841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-5.95|9.53||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.53|-5.95|
71773841|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-11.7|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|-21.7|-1.6|||mixed model repeated measures|||Week 24||-1.6|-21.7|
71773842|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-18.4|0.5|||mixed model repeated measures|||Week 36||0.5|-18.4|
71735830|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.87|||||TWO_SIDED|95.0|-10.89|5.14||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.14|-10.89|
71735831|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.86|||||TWO_SIDED|95.0|-14.8|1.08||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.08|-14.80|
71735832|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-22.34|-6.38||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.38|-22.34|
71735833|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.32|||||TWO_SIDED|95.0|-20.22|-4.41||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-4.41|-20.22|
71735834|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.14|||||TWO_SIDED|95.0|-10.12|5.85||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.85|-10.12|
71773843|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|90.0|-22.1|-1.7|||mixed model repeated measures|||Week 36||-1.7|-22.1|
71735835|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.05|||||TWO_SIDED|95.0|-22.05|-6.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.04|-22.05|
71735836|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||||TWO_SIDED|95.0|-9.83|7.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.30|-9.83|
71735837|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.67|-1.53||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.53|-18.67|
71735838|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.41|||||TWO_SIDED|95.0|-24.01|-6.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.82|-24.01|
71735839|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.79|||||TWO_SIDED|95.0|-20.33|-3.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.26|-20.33|
71735840|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-14.57|2.62||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.62|-14.57|
71735841|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.37|||||TWO_SIDED|95.0|-23.98|-6.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.76|-23.98|
71735842|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-9.49|9.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.03|-9.49|
71735843|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.36|||||TWO_SIDED|95.0|-19.64|-1.08||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.08|-19.64|
71735844|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.57|||||TWO_SIDED|95.0|-24.83|-6.32||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.32|-24.83|
71735845|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.34|||||TWO_SIDED|95.0|-20.56|-2.13||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.13|-20.56|
71735846|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-14.61|3.89||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.89|-14.61|
71735847|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.88|||||TWO_SIDED|95.0|-25.15|-6.61||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-6.61|-25.15|
71735848|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-10.32|8.94||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.94|-10.32|
71773844|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.88|||TWO_SIDED|90.0|-12.7|6.9|||mixed model repeated measures|||Week 48||6.9|-12.7|
71773845|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|90.0|-17.9|2.7|||mixed model repeated measures|||Week 48||2.7|-17.9|
71773846|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.96|||TWO_SIDED|90.0|-7.4|12.5|||mixed model repeated measures|||Week 72||12.5|-7.4|
71735849|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.27|||||TWO_SIDED|95.0|-19.95|-0.59||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-19.95|
71735850|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-29.34|-10.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-10.06|-29.34|
71735851|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.65|||||TWO_SIDED|95.0|-22.25|-3.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-3.04|-22.25|
71735852|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.6|||||TWO_SIDED|95.0|-17.24|2.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.04|-17.24|
71735853|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-28.99|-9.68||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-9.68|-28.99|
71735854|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.17|||||TWO_SIDED|95.0|3.18|19.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||19.16|3.18|
71735855|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.19|||||TWO_SIDED|95.0|-0.78|15.15||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||15.15|-0.78|
71735856|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-8.28|7.65||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.65|-8.28|
71735857|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-6.14|9.61||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.61|-6.14|
71735858|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.11|||||TWO_SIDED|95.0|5.51|22.71||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||22.71|5.51|
71735859|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.27|||||TWO_SIDED|95.0|-3.38|13.92||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.92|-3.38|
71735860|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-8.68|8.59||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.59|-8.68|
71735861|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.58|||||TWO_SIDED|95.0|-4.99|12.15||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||12.15|-4.99|
71773847|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.18|||TWO_SIDED|90.0|-11.1|9.6|||mixed model repeated measures|||Week 72||9.6|-11.1|
71773848|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|90.0|-8.7|11.5|||mixed model repeated measures|||Week 96||11.5|-8.7|
71660245|NCT01629966|142834821|SUPERIORITY||Least Squares Mean Difference|-1.37||||0.0536|TWO_SIDED|95.0|-2.75|0.02|||MMRM|||||0.02|-2.75|0.0536
71773849|NCT04437368|143047919|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-13.8|7.8|||mixed model repeated measures|||Week 96||7.8|-13.8|
71660246|NCT01629966|142834821|SUPERIORITY||Least Squares Mean Difference|-1.52||||0.0349|TWO_SIDED|95.0|-2.94|-0.11|||MMRM|||||-0.11|-2.94|0.0349
71735862|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.65|||||TWO_SIDED|95.0|6.38|24.93||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||24.93|6.38|
71773850|NCT04105543|143047953|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.22||||0.173|TWO_SIDED|95.0|-12.64|4.24|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for MDADI Composite Baseline to 3 months (n=9)||4.24|-12.64|0.173
71773851|NCT04105543|143047953|OTHER|nonparametric rank test|Median Difference (Final Values)|-9.998||||0.225|TWO_SIDED|95.0|-28.43|7.39|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for MDADI Composite Baseline to 6 months (n=5)||7.39|-28.43|0.225
71773852|NCT04105543|143047954|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.037||||0.779|TWO_SIDED|95.0|-0.246|0.09|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for Stimulated Saliva Flow Baseline to 3 months (n=8)||0.09|-0.246|0.779
71773853|NCT04105543|143047954|OTHER|nonparametric rank test|Median Difference (Final Values)|-0.049||||0.465|TWO_SIDED|95.0|-0.218|0.12|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Stimulated Saliva Flow Baseline to 6 months (n=4)||0.12|-0.218|0.465
71832727|NCT02980276|143169578|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.21||||0.367|TWO_SIDED|95.0|0.8|1.85|||Regression, Logistic|Unadjusted|Unadjusted|||1.85|0.8|0.367
71735863|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.53|||||TWO_SIDED|95.0|-3.81|14.86||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||14.86|-3.81|
71660247|NCT03801382|142834837|EQUIVALENCE|Validity and test-retest reliability were explored|Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED||||||t-test, 2 sided||||Validity and test-retest reliability were explored|||>.05
71735864|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-8.97|9.59||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.59|-8.97|
71735865|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.54|||||TWO_SIDED|95.0|-4.69|13.77||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||13.77|-4.69|
71735866|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.65|||||TWO_SIDED|95.0|9.03|28.27||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||28.27|9.03|
71735867|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.07|||||TWO_SIDED|95.0|-0.64|18.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||18.78|-0.64|
71735868|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-10.0|9.28||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.28|-10.00|
71735869|NCT01393639|142985843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.69|||||TWO_SIDED|95.0|-2.91|16.29||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||16.29|-2.91|
71735870|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.37|-0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.02|-0.37|
71735871|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.46|-0.11||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.11|-0.46|
71735872|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.45|-0.1||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.10|-0.45|
71735873|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.52|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.52|
71735874|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|||||TWO_SIDED|95.0|-0.35|0.0||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.00|-0.35|
71735875|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.53|-0.18||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.53|
71735876|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.31|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.31|
71735877|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.17|-0.54|
71773854|NCT04105543|143047955|OTHER|nonparametric rank test|Median Difference (Final Values)|-4.444||||0.213|TWO_SIDED|95.0|-14.4|4.4|||Wilcoxon Signed Rank Tests|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Functional Score Baseline to 3 months (n=9)||4.4|-14.4|0.213
71773855|NCT04105543|143047955|OTHER|nonparametric rank test|Median Difference (Final Values)|-6.667||||0.686|TWO_SIDED|95.0|-17.8|20.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Functional Scores Baseline to 6 months (n=5)||20|-17.8|0.686
71773856|NCT04105543|143047955|OTHER|nonparametric rank test|Median Difference (Final Values)|3.846||||0.498|TWO_SIDED|95.0|-0.769|12.82|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Symptom Score Baseline to 3 months (n=9)||12.82|-0.769|0.498
71773857|NCT04105543|143047955|OTHER|nonparametric rank test|Median Difference (Final Values)|10.256||||0.416|TWO_SIDED|95.0|-15.39|35.89|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Symptom Scores Baseline to 6 months (n=5)||35.89|-15.39|0.416
71832728|NCT02980276|143169578|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.22||||0.359|TWO_SIDED|95.0|0.8|1.87|||Regression, Logistic|Adjusted|Adjusted|||1.87|0.8|0.359
71832729|NCT02980276|143169579|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-6.5||||1|TWO_SIDED|95.0|-13.9|12.9|||Risk difference||Units are %|||12.9|-13.9|1.0
71735878|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.47|-0.09||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.47|
71735879|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.56|-0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.56|
71735880|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.39|-0.01||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.39|
71735881|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.63|-0.25||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.25|-0.63|
71735882|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.34|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.34|
71735883|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.59|-0.2||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.20|-0.59|
71735884|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.51|-0.12||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.12|-0.51|
71735885|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.55|-0.16||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.16|-0.55|
71735886|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.38|0.01||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.01|-0.38|
71773858|NCT04105543|143047955|OTHER|nonparametric rank test|Median Difference (Final Values)|-8.33||||0.778|TWO_SIDED|95.0|-20.84|16.67|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for EORTC QLQ-C30 Global Health Status Score Baseline to 3 months (n=9)||16.67|-20.84|0.778
71773859|NCT04105543|143047955|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.89|TWO_SIDED|95.0|-25.0|25.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for EORTC QLQ-C30 Global Health Status Scores Baseline to 6 months (n=5)||25|-25|0.89
71773860|NCT04105543|143047956|OTHER|nonparametric rank test|Median Difference (Final Values)|3.5||||0.138|TWO_SIDED|95.0|-2.0|9.5|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for XeQOL Baseline to 3 months (n=9)||9.5|-2|0.138
71832730|NCT02980276|143169580|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.603|TWO_SIDED|95.0|0.56|1.39|||Regression, Logistic|Unadjusted|Unadjusted|||1.39|0.56|0.603
71735887|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.67|-0.27||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.27|-0.67|
71735888|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.3|0.15||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.15|-0.30|
71735889|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.63|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.63|
71832731|NCT02980276|143169580|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.621|TWO_SIDED|95.0|0.57|1.4|||Regression, Logistic|Adjusted|Adjusted|||1.4|0.57|0.621
71832732|NCT02980276|143169581|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.89||||0.739|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|Unadjusted|Unadjusted|||1.76|0.45|0.739
71773861|NCT04105543|143047956|OTHER|nonparametric rank test|Median Difference (Final Values)|6.0||||0.225|TWO_SIDED|95.0|-10.0|16.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for XeQOL Baseline to 6 months (n=5)||16|-10|0.225
71773862|NCT04105543|143047957|OTHER|nonparametric rank test|Median Difference (Final Values)|0.5||||0.674|TWO_SIDED|95.0|-3.0|5.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Tests for Xerostomia Inventory Baseline to 3 months (n=9)||5|-3|0.674
71773863|NCT04105543|143047957|OTHER|nonparametric rank test|Median Difference (Final Values)|0.0||||0.892|TWO_SIDED|95.0|-6.0|6.0|||Wilcoxon Signed Rank Test|||Wilcoxon Signed Rank Test for Xerostomia Inventory Baseline to 6 months (n=5)||6|-6|0.892
71773864|NCT02393690|143047958|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
71773865|NCT02393690|143047959|SUPERIORITY|||||||0.0787|||||||Fisher Exact|||||||0.0787
71773866|NCT02393690|143047960|SUPERIORITY|||||||0.1764|||||||Log Rank|||||||0.1764
71773867|NCT02393690|143047961|SUPERIORITY|||||||0.0756|||||||Wilcoxon (Mann-Whitney)|||||||0.0756
71735890|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.64|-0.18||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.18|-0.64|
71735891|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.59|-0.14||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.14|-0.59|
71735892|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|||||TWO_SIDED|95.0|-0.54|-0.09||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.09|-0.54|
71735893|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-0.81|-0.35||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.35|-0.81|
71735894|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.01|0.34||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.01|
71735895|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.24|-0.10|
71735896|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.1|0.25||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.10|
71735897|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.18||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.17|
71735898|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.51||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.51|0.13|
71735899|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.11|0.27||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.11|
71735900|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.04|0.34||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.34|-0.04|
71773868|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.48|0.94|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 4||0.94|0.48|
71773869|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 6B||1.04|0.64|
71773870|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 9V||1.23|0.74|
71832733|NCT02980276|143169581|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.92||||0.812|TWO_SIDED|95.0|0.46|1.84|||Regression, Logistic|Adjusted|Adjusted|||1.84|0.46|0.812
71773871|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.45|1.01|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 14||1.01|0.45|
71773872|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.96|||||TWO_SIDED|95.0|0.7|1.31|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 18C||1.31|0.70|
71735901|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.13|0.25||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.25|-0.13|
71773873|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.56|||||TWO_SIDED|95.0|0.4|0.77|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 19F||0.77|0.40|
71773874|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 23F||1.05|0.64|
71773875|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.97|||||TWO_SIDED|95.0|1.39|2.8|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 4||2.80|1.39|
71773876|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|3.04|||||TWO_SIDED|95.0|2.41|3.84|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 6B||3.84|2.41|
71773877|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|1.26|||||TWO_SIDED|95.0|0.98|1.62|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 9V||1.62|0.98|
71773878|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|6.66|||||TWO_SIDED|95.0|4.53|9.79|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 14||9.79|4.53|
71773879|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.34|||||TWO_SIDED|95.0|1.68|3.24|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 18C||3.24|1.68|
71773880|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|4.47|||||TWO_SIDED|95.0|3.29|6.07|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 19F||6.07|3.29|
71773881|NCT01298544|143047994|SUPERIORITY_OR_OTHER||Ratio of GMCs|2.08|||||TWO_SIDED|95.0|1.65|2.63|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 23F||2.63|1.65|
71773882|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|-18.5|||||TWO_SIDED|95.0|-29.4|-7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 4||-7.3|-29.4|
71735902|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.13|0.52||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.52|0.13|
71735903|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.12|0.27||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.27|-0.12|
71773883|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.1|3.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 6B||3.0|-3.1|
71735904|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.05|0.35||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.35|-0.05|
71735905|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.08|0.31||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.31|-0.08|
71735906|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|||||TWO_SIDED|95.0|0.28|0.73||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.73|0.28|
71773884|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-5.9|7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 9V||7.3|-5.9|
71773885|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-10.3|3.1|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 14||3.1|-10.3|
71832734|NCT02980276|143169582|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|1.84||||0.282|TWO_SIDED|95.0|0.63|6.04|||Regression, Logistic|Unadjusted|Unadjusted|Unadjusted||6.04|0.63|0.282
71832735|NCT02980276|143169582|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|2.14||||0.196|TWO_SIDED|95.0|0.7|7.38|||Regression, Logistic||Adjusted|||7.38|0.7|0.196
71832736|NCT02980276|143169583|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.058|TWO_SIDED|95.0|0.27|1.01|||Regression, Logistic|Unadjusted||||1.01|0.27|0.058
71832737|NCT02980276|143169583|EQUIVALENCE|Two-sided test comparing observed odds ratio to 1.|Odds Ratio (OR)|0.53||||0.061|TWO_SIDED|95.0|0.27|1.02|||Regression, Logistic|Adjusted||||1.02|0.27|0.061
71832738|NCT02980276|143169584|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-4.5||||0.24|TWO_SIDED|95.0|-11.6|2.5|||Risk difference||Units are %|||2.5|-11.6|0.24
71832739|NCT02980276|143169584|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.81||||0.24|TWO_SIDED|95.0|0.59|1.12|||Regression, Logistic||Units are %|||1.12|0.59|0.24
71832740|NCT02980276|143169585|EQUIVALENCE|Regression model that adjusts for the infant's sex and maternal height and weight at randomization.|Median Difference (Final Values)|-113.0||||0.005|TWO_SIDED|95.0|-201.0|-24.0|||Regression, Linear|P value was derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization.||||-24|-201|0.005
71832741|NCT02980276|143169586|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.82|TWO_SIDED|95.0|-0.3|0.3|||t-test, 2 sided|||||0.3|-0.3|0.82
71832742|NCT02980276|143169587|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|-0.7||||0.02|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||||-0.2|-1.3|0.02
71832743|NCT02980276|143169588|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||||0.7|-0.5|0.72
71832744|NCT02980276|143169589|EQUIVALENCE|Two-sided test comparing observed mean difference to zero.|Mean Difference (Final Values)|0.0||||0.68|TWO_SIDED|95.0|-0.1|0.1|||t-test, 2 sided|||||0.1|-0.1|0.68
71773886|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|-11.9|||||TWO_SIDED|95.0|-22.7|-1.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 18C||-1.0|-22.7|
71773887|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-7.1|0.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 19F||0.6|-7.1|
71832745|NCT02980276|143169590|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-7.2||||0.02|TWO_SIDED|95.0|-12.6|-1.8|||Regression, Logistic|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|P value derived from a statistical model that adjusts for the infant's sex, gestational age at birth, and maternal height and weight at randomization.|||-1.8|-12.6|0.02
71832746|NCT02980276|143169591|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|-8.4||||0.003|TWO_SIDED|95.0|-13.7|-3.2|||Risk difference|P value derived from a statistical model that adjusts for the infant's sex and maternal height and weight at randomization|Units are %|||-3.2|-13.7|0.003
71832747|NCT02980276|143169592|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.7||||0.012|TWO_SIDED|95.0|-1.0|6.3|||Risk difference|Units are %. P value derived from model adjusting for the gestational age at birth, sex and maternal height and weight at randomization.|Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.3|-1|.012
71660248|NCT04188301|142834846|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
71735907|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.05|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.05|
71735908|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.06|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.06|
71735909|NCT01393639|142985845|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|||||TWO_SIDED|95.0|-0.01|0.44||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.01|
71735910|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.78|-0.04||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.04|-0.78|
71735911|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||||TWO_SIDED|95.0|-1.12|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.12|
71735912|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|95.0|-1.18|-0.44||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.18|
71735913|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|95.0|-1.48|-0.74||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.74|-1.48|
71735914|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-0.72|0.02||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.72|
71735915|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|||||TWO_SIDED|95.0|-1.19|-0.46||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.46|-1.19|
71773888|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.5|2.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2-Group 1), expressed as a percentage.|Serotype 23F||2.3|-4.5|
71773889|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|25.0|||||TWO_SIDED|95.0|12.7|37.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 4||37.0|12.7|
71773890|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-0.011|7.715|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 6B||7.715|-0.011|
71773891|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|10.3|||||TWO_SIDED|95.0|1.9|19.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 9V||19.6|1.9|
71773892|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|29.7|||||TWO_SIDED|95.0|19.4|40.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 14||40.5|19.4|
71735916|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.85|0.0||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.00|-0.85|
71773893|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|30.0|||||TWO_SIDED|95.0|17.9|41.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 18C||41.5|17.9|
71773894|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|6.5|||||TWO_SIDED|95.0|1.2|13.9|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 19F||13.9|1.2|
71773895|NCT01298544|143047995|SUPERIORITY_OR_OTHER||Difference in proportions|6.2|||||TWO_SIDED|95.0|1.8|13.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined-Group 3), expressed as a percentage.|Serotype 23F||13.0|1.8|
71773896|NCT02718300|143048002|SUPERIORITY|||||||0.4046|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.4046
71773897|NCT02718300|143048004|SUPERIORITY|||||||0.7802|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.7802
71773898|NCT02718300|143048006|SUPERIORITY|||||||0.6856|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.6856
71735917|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|95.0|-1.15|-0.31||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.31|-1.15|
71773899|NCT02718300|143048008|SUPERIORITY|||||||0.3385|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3385
71735918|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.37|-0.52||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.52|-1.37|
71735919|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.39|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.39|
71735920|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.67|0.18||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.18|-0.67|
71735921|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.33|-0.49||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.49|-1.33|
71735922|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.9|0.02||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.02|-0.90|
71735923|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|||||TWO_SIDED|95.0|-1.32|-0.41||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.41|-1.32|
71735924|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-1.53|-0.62||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.62|-1.53|
71735925|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|||||TWO_SIDED|95.0|-1.51|-0.6||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.60|-1.51|
71773900|NCT02718300|143048010|SUPERIORITY|||||||0.4005|||||||Van Elteren test|stratified by Easter Cooperative Oncology Group (ECOG) Performance Status at Screening (0 or 1 versus 2)||||||0.4005
71773901|NCT02718300|143048012|SUPERIORITY|||||||0.3138|||||||Van Elteren test|stratified by ECOG Performance Status at Screening (0 or 1 versus 2)||||||0.3138
71832748|NCT02980276|143169593|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.13|TWO_SIDED|95.0|-0.4|6.5||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|Regression, Logistic||Units are %. P value was derived from a statistical model that adjusts for the infant's gestational age at birth, sex and maternal height and weight at randomization.|||6.5|-0.4|0.13
71735926|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|||||TWO_SIDED|95.0|-0.89|0.03||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.89|
71735927|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-1.5|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.50|
71773902|NCT02718300|143048018|SUPERIORITY|||||||0.3577|||||||ANOVA|||Week 2||||0.3577
71773903|NCT02718300|143048018|SUPERIORITY||Geometric Mean Ratio (GMR)|1.048|||||TWO_SIDED|95.0|0.791|1.388|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.388|0.791|
71773904|NCT02718300|143048018|SUPERIORITY||GMR|1.159|||||TWO_SIDED|95.0|0.936|1.435|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.435|0.936|
71773905|NCT02718300|143048018|SUPERIORITY|||||||0.1709|||||||ANOVA|||Week 4||||0.1709
71773906|NCT02718300|143048018|SUPERIORITY||GMR|1.0|||||TWO_SIDED|95.0|0.78|1.281|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.281|0.780|
71773907|NCT02718300|143048018|SUPERIORITY||GMR|1.176|||||TWO_SIDED|95.0|0.955|1.448|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.448|0.955|
71773908|NCT02718300|143048019|SUPERIORITY|||||||0.6693|||||||Kruskal-Wallis|||Week 2||||0.6693
71773909|NCT02718300|143048019|SUPERIORITY|||||||0.1521|||||||Kruskal-Wallis|||Week 4||||0.1521
71735928|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-1.0|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.00|
71773910|NCT02718300|143048020|SUPERIORITY|||||||0.0809|||||||ANOVA|||Week 2||||0.0809
71889896|NCT00630331|143301579|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|53.2||||0.26|ONE_SIDED|97.5|22.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|||22.2|0.26
71735929|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|95.0|-1.4|-0.43||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.43|-1.40|
71773911|NCT02718300|143048020|SUPERIORITY||GMR|0.583|||||TWO_SIDED|95.0|0.342|0.994|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||0.994|0.342|
71773912|NCT02718300|143048020|SUPERIORITY||GMR|0.986|||||TWO_SIDED|95.0|0.658|1.477|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.477|0.658|
71889897|NCT01565980|143301600|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen's d: difference between LS means divided by the standard deviation.|Mixed Models Analysis|||The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.||||<.05
71889898|NCT01565980|143301601|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
71889899|NCT01565980|143301602|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<.05
71889900|NCT01565980|143301603|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
71889901|NCT01565980|143301604|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
71889902|NCT01565980|143301605|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis|||||||<0.05
71889903|NCT01565980|143301606|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values above 0.05 are considered statistically insignificant in this study.|Descriptive statistics for outcomes|||||||<0.05
71889904|NCT02078219|143301611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.28|||<|0.0001|TWO_SIDED|95.0|-36.99|-21.57|||ANCOVA, LOCF|||||-21.57|-36.99|<0.0001
71889905|NCT02078219|143301611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.25|||<|0.0001|TWO_SIDED|95.0|-56.97|-41.52|||ANCOVA, LOCF|||||-41.52|-56.97|<0.0001
71889906|NCT02078219|143301611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.33|||<|0.0001|TWO_SIDED|95.0|-61.0|-45.67|||ANCOVA, LOCF|||||-45.67|-61.00|<0.0001
71889907|NCT02761967|143301615|EQUIVALENCE|The statistical power of the study for the temporal variables was 82%. Multiple linear regression models were obtained for the first and second stages and for the total duration of delivery.||||||0.776|||||||Chi-squared|||||||0.776
71889908|NCT02292771|143301633|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.3797|TWO_SIDED|95.0|-8.879|6.479|||Finite mixture model|||||6.479|-8.879|0.3797
71889909|NCT02292771|143301634|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.44|2.18|||Regression, Logistic|||||2.18|0.44|0.9520
71889910|NCT02292771|143301635|SUPERIORITY||Odds Ratio (OR)|1.0||||0.952|TWO_SIDED|95.0|0.46|2.29|||Regression, Logistic|||||2.29|0.46|0.9520
71889911|NCT02292771|143301636|SUPERIORITY||Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.222||0.5672|TWO_SIDED|95.0|0.73|1.76|||ANCOVA|||||1.76|0.73|0.5672
71889912|NCT02292771|143301637|SUPERIORITY||Odds Ratio (OR)|1.9||||0.5066|TWO_SIDED|95.0|0.3|11.71|||Regression, Logistic|||||11.71|0.30|0.5066
71889913|NCT02292771|143301643|SUPERIORITY||Odds Ratio (OR)|0.8||||0.779|TWO_SIDED|95.0|0.12|4.84|||Regression, Logistic|||||4.84|0.12|0.7790
71889914|NCT02292771|143301644|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6646|TWO_SIDED|95.0|0.51|2.9|||Regression, Logistic|||||2.90|0.51|0.6646
71889915|NCT02292771|143301645|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1432|TWO_SIDED|95.0|0.75|7.24|||Regression, Logistic|||||7.24|0.75|0.1432
71889916|NCT02292771|143301646|SUPERIORITY||Odds Ratio (OR)|1.5||||0.525|TWO_SIDED|95.0|0.43|5.15|||Regression, Logistic|||||5.15|0.43|0.5250
71889917|NCT02292771|143301647|SUPERIORITY||Odds Ratio (OR)|0.6||||0.4682|TWO_SIDED|95.0|0.13|2.58|||Regression, Logistic|||||2.58|0.13|0.4682
71889918|NCT04025632|143301681|SUPERIORITY||Wilcoxon-Mann-Whitney odds|0.55||||0.464|TWO_SIDED|95.0|0.19|1.57||Conducted using a 2-sided Van Elteren test, which represents an extension of the Wilcoxon rank sum test for comparing 2 treatments in a stratified experiment using within-stratum ranks assigning greater weight to rank sums from smaller strata.|2-sided Van Elteren test||The magnitude of association between treatment groups was expressed as in Wilcoxon-Mann-Whitney odds followed by the 95% confidence intervals.|||1.57|0.19|0.464
71889919|NCT04025632|143301683|SUPERIORITY||Odds Ratio (OR)|1.088||||0.919|TWO_SIDED|95.0|0.214|5.535||P-value for the comparison of treatment groups was calculated using logistic regression with investigational medicinal product and strata as fixed factors.|Regression, Logistic|||||5.535|0.214|0.919
71889920|NCT04025632|143301684|SUPERIORITY||Least squares (LS) mean difference|-0.688||||0.496|TWO_SIDED|95.0|-2.781|1.404||Based on a linear model with treatment and strata (anti-3-hydroxy-3-methyl-glutaryl-coenzyme A reductase \[HMGCR\]+/anti-signal recognition particle \[SRP\]+) as fixed factors with Baseline 3TUG as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.404|-2.781|0.496
71735930|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|||||TWO_SIDED|95.0|-1.77|-0.8||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.80|-1.77|
71735931|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.69|-0.72||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.72|-1.69|
71735932|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.98|-0.01||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.01|-0.98|
71735933|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.69|-0.73||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.73|-1.69|
71735934|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|95.0|0.04|0.78||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|0.04|
71735935|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.29|0.44||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.29|
71735936|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.35|0.38||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.35|
71735937|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.65|0.08||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.65|
71735938|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|||||TWO_SIDED|95.0|0.06|0.91||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.91|0.06|
71735939|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.24|0.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.60|-0.24|
71735940|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.46|0.38||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.38|-0.46|
71735941|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.48|0.37||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.37|-0.48|
71735942|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|||||TWO_SIDED|95.0|0.15|1.06||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.06|0.15|
71735943|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|95.0|-0.28|0.63||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.63|-0.28|
71735944|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.49|0.42||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.49|
71735945|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.47|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.47|
71735946|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|0.22|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|0.22|
71735947|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.18|0.78||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.78|-0.18|
71773913|NCT02718300|143048020|SUPERIORITY|||||||0.1525|||||||ANOVA|||Week 4||||0.1525
71735948|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.55|0.4||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.40|-0.55|
71735949|NCT01393639|142985847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.47|0.49||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.49|-0.47|
71735950|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.76|0.03||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.03|-0.76|
71773914|NCT02718300|143048020|SUPERIORITY||GMR|1.062|||||TWO_SIDED|95.0|0.604|1.867|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.867|0.604|
71773915|NCT02718300|143048020|SUPERIORITY||GMR|1.504|||||TWO_SIDED|95.0|0.937|2.414|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||2.414|0.937|
71735951|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.39|-1.17|
71735952|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-1.32|-0.54||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.32|
71735953|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.17|||||TWO_SIDED|95.0|-1.56|-0.78||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.78|-1.56|
71735954|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.09||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.09|-0.70|
71735955|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-1.34|-0.55||||||Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.55|-1.34|
71735956|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.84|0.07||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.07|-0.84|
71735957|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||||TWO_SIDED|95.0|-1.23|-0.32||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.32|-1.23|
71735958|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.06|||||TWO_SIDED|95.0|-1.52|-0.61||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.61|-1.52|
71773916|NCT02718300|143048021|SUPERIORITY|||||||0.2873|||||||ANOVA|||Week 2||||0.2873
71773917|NCT02718300|143048021|SUPERIORITY||GMR|1.016|||||TWO_SIDED|95.0|0.773|1.336|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.336|0.773|
71889921|NCT04025632|143301685|SUPERIORITY||LS mean difference|3.89||||0.431|TWO_SIDED|95.0|-6.18|13.95||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline proximal MMT as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||13.95|-6.18|0.431
71735959|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.45|-0.54||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.54|-1.45|
71773918|NCT02718300|143048021|SUPERIORITY||GMR|1.161|||||TWO_SIDED|95.0|0.943|1.429|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 2||1.429|0.943|
71773919|NCT02718300|143048021|SUPERIORITY|||||||0.1601|||||||ANOVA|||Week 4||||0.1601
71773920|NCT02718300|143048021|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.773|1.274|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.274|0.773|
71773921|NCT02718300|143048021|SUPERIORITY||GMR|1.177|||||TWO_SIDED|95.0|0.955|1.452|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.452|0.955|
71773922|NCT02718300|143048025|SUPERIORITY|||||||0.083|||||||ANOVA|||Day 1||||0.0830
71773923|NCT02718300|143048025|SUPERIORITY||GMR|1.218|||||TWO_SIDED|95.0|0.846|1.753|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.753|0.846|
71773924|NCT02718300|143048025|SUPERIORITY||GMR|0.957|||||TWO_SIDED|95.0|0.654|1.399|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.399|0.654|
71773925|NCT02718300|143048025|SUPERIORITY||GMR|0.943|||||TWO_SIDED|95.0|0.656|1.354|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.354|0.656|
71735960|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.71|0.21||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.21|-0.71|
71735961|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02|||||TWO_SIDED|95.0|-1.48|-0.57||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.57|-1.48|
71735962|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.89|0.11||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.11|-0.89|
71735963|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|95.0|-1.44|-0.45||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.45|-1.44|
71735964|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|95.0|-1.71|-0.71||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.71|-1.71|
71735965|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-1.59|-0.59||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.59|-1.59|
71735966|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-0.95|0.05||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-0.95|
71773926|NCT02718300|143048025|SUPERIORITY||GMR|0.867|||||TWO_SIDED|95.0|0.579|1.298|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.298|0.579|
71735967|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-1.65|-0.66||||||Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.66|-1.65|
71735968|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|||||TWO_SIDED|95.0|-0.96|0.08||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.08|-0.96|
71735969|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.48|-0.44||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.44|-1.48|
71735970|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|95.0|-1.94|-0.91||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.91|-1.94|
71773927|NCT02718300|143048025|SUPERIORITY|||||||0.2402|||||||ANOVA|||Week 4||||0.2402
71773928|NCT02718300|143048025|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.461|1.069|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.069|0.461|
71773929|NCT02718300|143048025|SUPERIORITY||GMR|0.7|||||TWO_SIDED|95.0|0.456|1.073|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.073|0.456|
71773930|NCT02718300|143048025|SUPERIORITY||GMR|0.638|||||TWO_SIDED|95.0|0.428|0.951|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.951|0.428|
71889922|NCT04025632|143301686|SUPERIORITY||LS mean difference|-0.204||||0.8|TWO_SIDED|95.0|-1.855|1.448||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Physician Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||1.448|-1.855|0.800
71773931|NCT02718300|143048025|SUPERIORITY||GMR|0.627|||||TWO_SIDED|95.0|0.397|0.99|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||0.990|0.397|
71773932|NCT02718300|143048026|SUPERIORITY|||||||0.0756|||||||Kruskal-Wallis|||Day 1||||0.0756
71773933|NCT02718300|143048026|SUPERIORITY|||||||0.0866|||||||Kruskal-Wallis|||Week 4||||0.0866
71773934|NCT02718300|143048027|SUPERIORITY|||||||0.4287|||||||ANOVA|||Day 1||||0.4287
71773935|NCT02718300|143048027|SUPERIORITY||GMR|1.272|||||TWO_SIDED|95.0|0.329|4.914|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.914|0.329|
71773936|NCT02718300|143048027|SUPERIORITY||GMR|1.036|||||TWO_SIDED|95.0|0.252|4.251|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||4.251|0.252|
71773937|NCT02718300|143048027|SUPERIORITY||GMR|0.702|||||TWO_SIDED|95.0|0.18|2.731|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.731|0.180|
71773938|NCT02718300|143048027|SUPERIORITY||GMR|0.525|||||TWO_SIDED|95.0|0.118|2.348|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||2.348|0.118|
71773939|NCT02718300|143048027|SUPERIORITY|||||||0.9788|||||||ANOVA|||Week 4||||0.9788
71773940|NCT02718300|143048027|SUPERIORITY||GMR|0.879|||||TWO_SIDED|95.0|0.198|3.896|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.896|0.198|
71773941|NCT02718300|143048027|SUPERIORITY||GMR|1.225|||||TWO_SIDED|95.0|0.27|5.56|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||5.560|0.270|
71773942|NCT02718300|143048027|SUPERIORITY||GMR|0.918|||||TWO_SIDED|95.0|0.221|3.821|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||3.821|0.221|
71773943|NCT02718300|143048027|SUPERIORITY||GMR|0.853|||||TWO_SIDED|95.0|0.169|4.299|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||4.299|0.169|
71773944|NCT02718300|143048028|SUPERIORITY|||||||0.1208|||||||ANOVA|||Day 1||||0.1208
71832749|NCT02980276|143169594|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|3.0||||0.38|TWO_SIDED|95.0|-2.9|9.0|||Risk difference||Units are %.|||9|-2.9|0.38
71735971|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-1.8|-0.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.76|-1.80|
71735972|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||||TWO_SIDED|95.0|-1.06|-0.03||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.03|-1.06|
71735973|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|||||TWO_SIDED|95.0|-1.85|-0.81||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.81|-1.85|
71735974|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59|||||TWO_SIDED|95.0|0.19|0.98||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.98|0.19|
71735975|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.22|0.56||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.22|
71735976|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.38|0.41||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.41|-0.38|
71735977|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.62|0.16||||||Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.16|-0.62|
71735978|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.18|1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.09|0.18|
71735979|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.21|0.7||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.21|
71773945|NCT02718300|143048028|SUPERIORITY||GMR|1.251|||||TWO_SIDED|95.0|0.832|1.879|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.879|0.832|
71773946|NCT02718300|143048028|SUPERIORITY||GMR|0.992|||||TWO_SIDED|95.0|0.649|1.518|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.518|0.649|
71773947|NCT02718300|143048028|SUPERIORITY||GMR|0.967|||||TWO_SIDED|95.0|0.645|1.45|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.450|0.645|
71773948|NCT02718300|143048028|SUPERIORITY||GMR|0.86|||||TWO_SIDED|95.0|0.548|1.35|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Day 1||1.350|0.548|
71773949|NCT02718300|143048028|SUPERIORITY|||||||0.3218|||||||ANOVA|||Week 4||||0.3218
71773950|NCT02718300|143048028|SUPERIORITY||GMR|0.761|||||TWO_SIDED|95.0|0.482|1.2|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.200|0.482|
71773951|NCT02718300|143048028|SUPERIORITY||GMR|0.803|||||TWO_SIDED|95.0|0.506|1.277|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.277|0.506|
71773952|NCT02718300|143048028|SUPERIORITY||GMR|0.667|||||TWO_SIDED|95.0|0.432|1.028|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.028|0.432|
71773953|NCT02718300|143048028|SUPERIORITY||GMR|0.64|||||TWO_SIDED|95.0|0.39|1.051|||||ANOVA was performed on dose-normalized PK parameters per dose level. The reference group was 5 mg QD.|Week 4||1.051|0.390|
71773954|NCT02247531|143048039|SUPERIORITY||Difference in Adjusted Means|0.157||||0.0479|TWO_SIDED|95.0|0.001|0.313|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.313|0.001|0.0479
71832750|NCT02980276|143169595|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.8||||0.33|TWO_SIDED|95.0|-2.0|7.3|||Risk difference||Units are %|||7.3|-2.0|0.33
71832751|NCT02980276|143169596|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|2.3||||0.42|TWO_SIDED|95.0|-2.4|6.9|||Risk difference||Units are %|||6.9|-2.4|0.42
71832752|NCT02980276|143169597|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.4|||>|0.99|TWO_SIDED|95.0|-0.4|1.1|||Risk difference||Units are %.|||1.1|-0.4|>0.99
71773955|NCT02247531|143048039|SUPERIORITY||Difference in Adjusted Means|0.087||||0.2739|TWO_SIDED|95.0|-0.069|0.243|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.243|-0.069|0.2739
71773956|NCT02247531|143048040|SUPERIORITY||Difference in Adjusted Means|-0.4||||0.84|TWO_SIDED|95.0|-4.8|3.9|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||3.9|-4.8|0.8400
71773957|NCT02247531|143048040|SUPERIORITY||Difference in Adjusted Means|1.3||||0.5587|TWO_SIDED|95.0|-3.1|5.7|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.7|-3.1|0.5587
71773958|NCT02247531|143048041|SUPERIORITY||Difference in Adjusted Means|0.1||||0.8358|TWO_SIDED|95.0|-0.88|1.09|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.09|-0.88|0.8358
71773959|NCT02247531|143048041|SUPERIORITY||Difference in Adjusted Means|-0.26||||0.6117|TWO_SIDED|95.0|-1.25|0.74|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.74|-1.25|0.6117
71773960|NCT02247531|143048042|SUPERIORITY||Difference in Adjusted Means|0.7||||0.4651|TWO_SIDED|95.0|-1.2|2.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.5|-1.2|0.4651
71773961|NCT02247531|143048042|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7885|TWO_SIDED|95.0|-1.6|2.1|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.1|-1.6|0.7885
71773962|NCT02247531|143048043|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6892|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||||1.8|0.7|0.6892
71773963|NCT02247531|143048043|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9104|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9104
71773964|NCT02247531|143048044|SUPERIORITY||Difference in Adjusted Means|-0.1||||0.8931|TWO_SIDED|95.0|-1.8|1.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.5|-1.8|0.8931
71773965|NCT02247531|143048044|SUPERIORITY||Difference in Adjusted Means|-1.1||||0.1754|TWO_SIDED|95.0|-2.8|0.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||0.5|-2.8|0.1754
71832753|NCT02980276|143169598|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|1.1||||0.62|TWO_SIDED|95.0|-1.9|4.2|||Risk difference||Units are %|||4.2|-1.9|0.62
71832754|NCT02980276|143169599|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.0|||>|0.99|TWO_SIDED|95.0|-1.0|1.0|||Risk difference||Units are %|||1|-1|>0.99
71773966|NCT02247531|143048045|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3707|TWO_SIDED|95.0|0.7|2.2|||Regression, Logistic|||||2.2|0.7|0.3707
71773967|NCT02247531|143048045|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8382|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.8382
71773968|NCT02247531|143048046|SUPERIORITY||Difference in Adjusted Means|1.35||||0.6841|TWO_SIDED|95.0|-5.16|7.85|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.85|-5.16|0.6841
71773969|NCT02247531|143048046|SUPERIORITY||Difference in Adjusted Means|1.07||||0.7443|TWO_SIDED|95.0|-5.37|7.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||7.52|-5.37|0.7443
71773970|NCT02247531|143048047|SUPERIORITY||Difference in Adjusted Means|0.12||||0.9713|TWO_SIDED|95.0|-6.28|6.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||6.52|-6.28|0.9713
71773971|NCT02247531|143048047|SUPERIORITY||Difference in Adjusted Means|-1.72||||0.5945|TWO_SIDED|95.0|-8.08|4.63|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.||4.63|-8.08|0.5945
71773972|NCT02247531|143048048|SUPERIORITY||Difference in Adjusted Means|1.22||||0.2438|TWO_SIDED|95.0|-0.83|3.27|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.27|-0.83|0.2438
71832755|NCT02980276|143169600|EQUIVALENCE|Two-sided test comparing observed risk difference to zero.|Risk Difference (RD)|0.7||||0.9|TWO_SIDED|95.0|-5.1|6.6|||Risk difference||Units are %|||6.6|-5.1|0.9
71832756|NCT05286385|143169601|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.59|||TWO_SIDED|95.0|-6.29|0.29||||||||0.29|-6.29|
71832757|NCT05286385|143169602|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|-2.3|STANDARD_DEVIATION|8.03|||TWO_SIDED|95.0|-8.04|3.44||||||||3.44|-8.04|
71832758|NCT05286385|143169603|NON_INFERIORITY|Non-inferiority margin -10%|Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|4.55|||TWO_SIDED|95.0|-2.95|3.55||||||||3.55|-2.95|
71735980|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.5|0.42||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.50|
71735981|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.43|0.48||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.48|-0.43|
71735982|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|0.26|1.26||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.26|0.26|
71735983|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|-0.29|0.7||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.70|-0.29|
71735984|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.55|0.44||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.44|-0.55|
71735985|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.43|0.56||||||Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.56|-0.43|
71735986|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||||TWO_SIDED|95.0|0.37|1.41||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.41|0.37|
71773973|NCT02247531|143048048|SUPERIORITY||Difference in Adjusted Means|1.03||||0.3202|TWO_SIDED|95.0|-1.01|3.07|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.07|-1.01|0.3202
71735987|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-0.15|0.89||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.89|-0.15|
71735988|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.61|0.42||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.42|-0.61|
71735989|NCT01393639|142985849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-0.46|0.57||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.57|-0.46|
71735990|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|||||TWO_SIDED|95.0|-4.94|2.17||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.17|-4.94|
71735991|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||||TWO_SIDED|95.0|-3.98|3.08||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.08|-3.98|
71735992|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-3.34|3.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.82|-3.34|
71889923|NCT04025632|143301687|SUPERIORITY||LS mean difference|-1.281||||0.221|TWO_SIDED|95.0|-3.39|0.829||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline Patient Global Activity VAS as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.829|-3.390|0.221
71735993|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.75|4.28||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.28|-2.75|
71735994|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.31|||||TWO_SIDED|95.0|-4.88|2.27||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.27|-4.88|
71735995|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.25|||||TWO_SIDED|95.0|-1.32|5.82||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.82|-1.32|
71773974|NCT02247531|143048049|SUPERIORITY||Difference in Adjusted Means|2.64||||0.0388|TWO_SIDED|95.0|0.14|5.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||5.14|0.14|0.0388
71832759|NCT04188379|143169657|SUPERIORITY||Odds Ratio (OR)|4.884||||0.0316|TWO_SIDED|95.0|1.007|43.591|||Cochran-Mantel-Haenszel|||||43.591|1.007|0.0316
71832760|NCT04188379|143169658|SUPERIORITY||Median Difference (Net)|1.0||||0.0009|TWO_SIDED|95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4.000|0.000|0.0009
71832761|NCT04188379|143169659|SUPERIORITY||Odds Ratio (OR)|5.224||||0.0108|TWO_SIDED|95.0|1.268|26.268|||Cochran-Mantel-Haenszel|||||26.268|1.268|0.0108
71832762|NCT04188379|143169660|SUPERIORITY||Rate Ratio|0.958||||0.8287|TWO_SIDED|95.0|0.651|1.41|||Wald Test|||||1.41|0.651|0.8287
71832763|NCT04188379|143169661|SUPERIORITY||Odds Ratio (OR)|4.354||||0.0265|TWO_SIDED|95.0|1.048|22.865|||Cochran-Mantel-Haenszel|||||22.865|1.0480|0.0265
71832764|NCT03112174|143169674|SUPERIORITY||Hazard Ratio (HR)|0.629||||0.0024|TWO_SIDED|95.0|0.465|0.85||P value is from stratified log-rank test.|Log Rank|||||0.850|0.465|0.0024
71832765|NCT03112174|143169680|SUPERIORITY||Rate Ratio|1.658||||0.0004|TWO_SIDED|95.0|1.24|2.218||Estimate and p-value for rate ratio are based on Cochran-Mantel-Haenszel (CMH) test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||2.218|1.240|0.0004
71832766|NCT03112174|143169681|SUPERIORITY||Rate Ratio|1.101||||0.1279|TWO_SIDED|95.0|0.973|1.247||Estimate and p-value for rate ratio are based on CMH test adjusted for two randomization stratification factors: number of prior lines of therapy (1-2 vs \>=3) and TLS category (low risk vs increased risk) at randomization.|Cochran-Mantel-Haenszel||For rate ratio, numerator is Ibrutinib + Venetoclax arm and denominator is Ibrutinib + Placebo arm.|||1.247|0.973|0.1279
71889924|NCT04025632|143301688|SUPERIORITY||LS mean difference|-0.147||||0.508|TWO_SIDED|95.0|-0.601|0.307||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline HAQ as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.307|-0.601|0.508
71832767|NCT03112174|143169682|SUPERIORITY|||||||0.2028|||||||Fisher Exact|||Bone marrow aspirate||||0.2028
71832768|NCT03112174|143169682|SUPERIORITY|||||||0.0014|||||||Fisher Exact|||Peripheral blood||||0.0014
71832769|NCT03112174|143169683|SUPERIORITY||Hazard Ratio (HR)|0.832||||0.2669|TWO_SIDED|95.0|0.602|1.151||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||1.151|0.602|0.2669
71832770|NCT03112174|143169685|SUPERIORITY||Hazard Ratio (HR)|0.541||||0.0013|TWO_SIDED|95.0|0.369|0.792||P value is from stratified log-rank test.|Log Rank||Hazard ratio is estimated using stratified Cox regression model with treatment as the only covariate.|||0.792|0.369|0.0013
71889925|NCT04025632|143301689|SUPERIORITY||LS mean difference|-0.143||||0.765|TWO_SIDED|95.0|-1.123|0.837|||Linear Mixed Effect Model|Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline MDAAT as a covariate.|The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||0.837|-1.123|0.765
71832771|NCT03112174|143169700|SUPERIORITY||Hazard Ratio (HR)|1.169||||0.2861|TWO_SIDED|95.0|0.879|1.554||P value is from stratified log-rank test.|Log Rank|||||1.554|0.879|0.2861
71832772|NCT05773313|143169705|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Food Insecurity||||>0.999
71832773|NCT05773313|143169705|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Financial Insecurity||||0.250
71832774|NCT05773313|143169705|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Social Isolation||||>0.999
71832775|NCT05773313|143169705|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Physical Inactivity||||>0.999
71832776|NCT05773313|143169705|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Disability||||>0.999
71832777|NCT05773313|143169706|SUPERIORITY|||||||0.461|||||||Wilcoxon (Mann-Whitney)|||||||0.461
71832778|NCT05773313|143169707|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||||||>0.999
71832779|NCT05773313|143169708|SUPERIORITY|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
71832780|NCT05773313|143169709|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
71832781|NCT02748317|143169710|OTHER|1 group t-test no comparison group|||||=|0.219||||||P-value is not adjusted|t-test, 2 sided|||||||=0.219
71832782|NCT00802464|143169724|OTHER||Fold increase|5.21|||||TWO_SIDED|95.0|3.89|6.98||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||6.98|3.89|
71832783|NCT00802464|143169724|OTHER||Fold increase|4.02|||||TWO_SIDED|95.0|3.0|5.4||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||5.4|3|
71832784|NCT00802464|143169724|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.07|1.58||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.58|1.07|
71832785|NCT00802464|143169725|OTHER||Fold increase|2.12|||||TWO_SIDED|95.0|1.67|2.69||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.||2.69|1.67|
71832786|NCT00802464|143169725|OTHER||Fold increase|1.63|||||TWO_SIDED|95.0|1.28|2.07||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.||2.07|1.28|
71773975|NCT02247531|143048049|SUPERIORITY||Difference in Adjusted Means|2.2||||0.0833|TWO_SIDED|95.0|-0.29|4.68|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||4.68|-0.29|0.0833
71773976|NCT02247531|143048050|SUPERIORITY||Difference in Adjusted Means|1.04||||0.4795|TWO_SIDED|95.0|-1.84|3.91|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.91|-1.84|0.4795
71773977|NCT02247531|143048050|SUPERIORITY||Difference in Adjusted Means|0.6||||0.6822|TWO_SIDED|95.0|-2.26|3.45|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.45|-2.26|0.6822
71773978|NCT02247531|143048051|SUPERIORITY||Difference in Adjusted Means|0.04||||0.5227|TWO_SIDED|95.0|-0.07|0.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.14|-0.07|0.5227
71773979|NCT02247531|143048051|SUPERIORITY||Difference in Adjusted Means|0.02||||0.7475|TWO_SIDED|95.0|-0.09|0.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.13|-0.09|0.7475
71735996|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.89|1.87||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-5.89|
71735997|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.49|||||TWO_SIDED|95.0|-2.41|5.4||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.40|-2.41|
71735998|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.45|||||TWO_SIDED|95.0|-2.44|5.34||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.34|-2.44|
71773980|NCT02247531|143048052|SUPERIORITY||Difference in Adjusted Means|0.049||||0.6333|TWO_SIDED|95.0|-0.153|0.252|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.252|-0.153|0.6333
71832787|NCT00802464|143169725|OTHER||Fold increase|1.3|||||TWO_SIDED|95.0|1.09|1.56||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.||1.56|1.09|
71735999|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||||TWO_SIDED|95.0|-1.98|5.76||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.76|-1.98|
71736000|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|-3.16|4.61||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.61|-3.16|
71736001|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.18|||||TWO_SIDED|95.0|0.29|8.06||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.06|0.29|
71773981|NCT02247531|143048052|SUPERIORITY||Difference in Adjusted Means|0.025||||0.8105|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.230|-0.180|0.8105
71773982|NCT02247531|143048052|SUPERIORITY||Difference in Adjusted Means|0.34||||0.0063|TWO_SIDED|95.0|0.097|0.584|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.584|0.097|0.0063
71832788|NCT00802464|143169726|OTHER||Fold increase|4.72|||||TWO_SIDED|95.0|3.81|5.85||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||5.85|3.81|
71773983|NCT02247531|143048052|SUPERIORITY||Difference in Adjusted Means|0.182||||0.1359|TWO_SIDED|95.0|-0.058|0.422|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.422|-0.058|0.1359
71773984|NCT01298531|143048055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.27||||0.0019|TWO_SIDED|95.0|-44.17|-10.38|||ANCOVA|Not specifed.||The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.||-10.38|-44.17|0.0019
71832789|NCT00802464|143169726|OTHER||Fold increase|3.36|||||TWO_SIDED|95.0|2.72|4.17||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||4.17|2.72|
71736002|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-7.21|-0.06||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-0.06|-7.21|
71736003|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-6.25|0.85||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.85|-6.25|
71736004|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.01|||||TWO_SIDED|95.0|-5.63|1.6||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.60|-5.63|
71736005|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|||||TWO_SIDED|95.0|-5.02|2.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.05|-5.02|
71736006|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.19|||||TWO_SIDED|95.0|-10.07|-2.31||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-2.31|-10.07|
71736007|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-6.6|1.23||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.23|-6.60|
71736008|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-6.64|1.18||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.18|-6.64|
71736009|NCT01393639|142985851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|||||TWO_SIDED|95.0|-6.16|1.58||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.58|-6.16|
71736010|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.73|||||TWO_SIDED|95.0|-0.83|4.3||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.30|-0.83|
71736011|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.35|5.45||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||5.45|0.35|
71736012|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.12|||||TWO_SIDED|95.0|3.54|8.7||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||8.70|3.54|
71736013|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.73|||||TWO_SIDED|95.0|2.19|7.26||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.26|2.19|
71736014|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.18|||||TWO_SIDED|95.0|-0.39|4.76||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.76|-0.39|
71736015|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.41|||||TWO_SIDED|95.0|2.83|7.99||||||Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.99|2.83|
71773985|NCT01298531|143048056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.78||||0.0115|TWO_SIDED|95.0|-34.99|-4.57|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.||-4.57|-34.99|0.0115
71736016|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.79|||||TWO_SIDED|95.0|-1.08|4.65||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||4.65|-1.08|
71736017|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|||||TWO_SIDED|95.0|1.52|7.28||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||7.28|1.52|
71832790|NCT00802464|143169726|OTHER||Fold increase|1.4|||||TWO_SIDED|95.0|1.17|1.68||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.68|1.17|
71736018|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.2|||||TWO_SIDED|95.0|3.33|9.07||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.07|3.33|
71736019|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|0.85|6.55||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.55|0.85|
71736020|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.61|||||TWO_SIDED|95.0|0.74|6.47||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||6.47|0.74|
71736021|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|||||TWO_SIDED|95.0|3.29|9.04||||||Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||9.04|3.29|
71832791|NCT00802464|143169727|OTHER||Fold increase|3.21|||||TWO_SIDED|36.0|2.64|3.9||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.||3.9|2.64|
71832792|NCT00802464|143169727|OTHER||Fold increase|2.44|||||TWO_SIDED|95.0|2.02|2.97||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.||2.97|2.02|
71832793|NCT00802464|143169727|OTHER||Fold increase|1.31|||||TWO_SIDED|95.0|1.12|1.54||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.||1.54|1.12|
71736022|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68|||||TWO_SIDED|95.0|-6.27|-1.09||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.09|-6.27|
71736023|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.51|||||TWO_SIDED|95.0|-5.07|0.05||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.05|-5.07|
71736024|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|||||TWO_SIDED|95.0|-1.88|3.3||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||3.30|-1.88|
71736025|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-3.23|1.87||||||Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.87|-3.23|
71736026|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.38|||||TWO_SIDED|95.0|-7.26|-1.5||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||-1.50|-7.26|
71736027|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-4.65|1.12||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||1.12|-4.65|
71736028|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-2.84|2.91||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||2.91|-2.84|
71736029|NCT01393639|142985853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-5.33|0.39||||||Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.||0.39|-5.33|
71736030|NCT00793325|142985870|SUPERIORITY_OR_OTHER||||||=|0.575|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<15 years and \>=15 years in the frequency of treatment related adverse events."||||=0.575
71736031|NCT00793325|142985871|SUPERIORITY_OR_OTHER||||||=|0.206|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.206
71736032|NCT00793325|142985872|SUPERIORITY_OR_OTHER||||||=|0.033|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity. The null hypothesis is that there is no association between mild, moderate and severe in the frequency of treatment related adverse events."||||=0.033
71736033|NCT00793325|142985872|SUPERIORITY_OR_OTHER||||||=|0.207|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Severity. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity."||||=0.207
71832794|NCT00402246|143169744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|17.4|||<|0.001||95.0||||The a priori threshold for significance was an alpha level of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||||<0.001
71889926|NCT04025632|143301690|SUPERIORITY||LS mean difference|5.53||||0.265|TWO_SIDED|95.0|-4.49|15.55||Based on a linear model with treatment and strata (anti-HMGCR+/anti-SRP+) as fixed factors with Baseline FACIT-Fatigue Scale as a covariate.|Linear Mixed Effect Model||The difference presented is zilucoplan 0.3 mg/kg minus placebo.|||15.55|-4.49|0.265
71736034|NCT00793325|142985873|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Past history of any disease. The null hypothesis is that there is no difference between With past history of any disease and Without past history any disease in the frequency of treatment related adverse events."||||=0.013
71736035|NCT00793325|142985874|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Complication(s). The null hypothesis is that there is no difference between With complication(s) and Without complication(s)in the frequency of treatment related adverse events."||||=0.009
71736036|NCT00793325|142985875|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Hepatic Function Disorder. The null hypothesis is that there is no difference between with Hepatic Function Disorder and without Hepatic Function Disorder in the frequency of treatment related adverse events."||||<0.001
71736037|NCT00793325|142985876|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Renal Impairment. The null hypothesis is that there is no difference between With Renal Impairment and Without Renal Impairment in the frequency of treatment related adverse events."||||<0.001
71736038|NCT00793325|142985877|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Concomitant Drug(s). The null hypothesis is that there is no difference between With Concomitant Drug(s) and Without Concomitant Drug(s) in the frequency of treatment related adverse events."||||=0.003
71736039|NCT00793325|142985878|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
71773986|NCT01298531|143048057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0153|TWO_SIDED|95.0|-1.68|-0.18|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.||-0.18|-1.68|0.0153
71773987|NCT01298531|143048058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.051|TWO_SIDED|95.0|-1.76|0.0|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.||0.00|-1.76|0.0510
71832795|NCT00402246|143169745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.524|ONE_SIDED|95.0||1.21||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.21||0.524
71889927|NCT02274688|143301706|SUPERIORITY||||||=|0.01|||||||Wald Chi-Square=11.29, df=3, P=0.01|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.01
71736040|NCT00793325|142985878|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
71736041|NCT00793325|142985878|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
71736042|NCT00793325|142985879|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at one year and SGA at baseline.||||<0.001
71736043|NCT00793325|142985879|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline.||||<0.001
71773988|NCT01298531|143048060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.209||||0.0066|TWO_SIDED|95.0|0.07|0.65|||Regression, Logistic|||Logistic regression with baseline score and treatment group included as covariates.||0.65|0.07|0.0066
71889928|NCT02274688|143301707|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=3.01, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
71736044|NCT00793325|142985879|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline.||||<0.001
71736045|NCT01815840|142985880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-22.2|5.7|||||Asymptotic confidence intervals are presented for the difference between treatment arms.|The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.||5.7|-22.2|
71736046|NCT00434642|142985926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.388|0.605||A P-value \< 0.05 was required for significance.|Log Rank|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.||0.605|0.388|<0.0001
71736047|NCT00434642|142985927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.1|||<|0.0001|TWO_SIDED|95.0|13.0|29.2||A P-value \< 0.05 was required for significance.|Cochran-Mantel-Haenszel|The analysis was stratified for time since the last platinum therapy (6-12, \> 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.|The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.||29.2|13.0|<0.0001
71736048|NCT00434642|142985929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.6479|TWO_SIDED|95.0|0.771|1.176||Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.|Log Rank|The analysis was stratified for time since the last platinum therapy (≤12, \>12 months) and cytoreductive surgery for recurrent disease (Yes, No).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|||1.176|0.771|0.6479
71736049|NCT00789672|142985964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_DEVIATION|4.7|||TWO_SIDED|95.0|-6.0|1.0||||||Given this was pilot study, no formal sample size estimates were calculated.||1|-6|
71736050|NCT01463072|142985990|OTHER||Percent|35.0|||||TWO_SIDED|95.0|21.0|52.0|||||35% of participants were responders (CR+PR).|||52|21|
71736051|NCT01463072|142985992|SUPERIORITY||Odds Ratio (OR)|5.8||||0.01|TWO_SIDED|95.0|1.3|33.1|||Fisher Exact||Ratio is intermediate/high toxicity risk over low toxicity risk|CARG chemotherapy toxicity risk predictive of chemotherapy toxicity (grade 3)||33.1|1.3|0.01
71736052|NCT01463072|142985992|SUPERIORITY||Ratio of group means|1.38||||0.02|TWO_SIDED|95.0|1.04|1.8|||t-test, 2 sided||Ratio is dose reduction over no dose reduction.|CARG chemotherapy toxicity risk predictive of dose reduction due to chemotherapy toxicity||1.80|1.04|0.02
71736053|NCT02473367|142986087|SUPERIORITY_OR_OTHER||Geom. least-squares mean ratio (GLSMR)|0.28|||||TWO_SIDED|90.0|0.24|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.24|
71736054|NCT02473367|142986087|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.73|1.03|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.03|0.73|
71736055|NCT02473367|142986087|SUPERIORITY_OR_OTHER||GLSMR|0.9|||||TWO_SIDED|90.0|0.8|1.03|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.03|0.80|
71736056|NCT02473367|142986088|SUPERIORITY_OR_OTHER||GLSMR|0.26|||||TWO_SIDED|90.0|0.21|0.32|||||Raltegravir+TUMS/Raltegravir only|||0.32|0.21|
71773989|NCT01298531|143048061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.7||||0.0053|TWO_SIDED|95.0|-91.01|-16.38|||ANCOVA|||The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.||-16.38|-91.01|0.0053
71773990|NCT01298531|143048062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.963||||0.0324|TWO_SIDED|95.0|1.1|8.01|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.01|1.10|0.0324
71773991|NCT01298531|143048065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0501|TWO_SIDED|95.0|1.0|7.27|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||7.27|1.00|0.0501
71773992|NCT01298531|143048067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.103||||0.0284|TWO_SIDED|95.0|1.13|8.54|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||8.54|1.13|0.0284
71736057|NCT02473367|142986088|SUPERIORITY_OR_OTHER||GLSMR|0.86|||||TWO_SIDED|90.0|0.65|1.15|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||1.15|0.65|
71736058|NCT02473367|142986088|SUPERIORITY_OR_OTHER||GLSMR|0.98|||||TWO_SIDED|90.0|0.81|1.17|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||1.17|0.81|
71736059|NCT02473367|142986089|SUPERIORITY_OR_OTHER||GLSMR|0.52|||||TWO_SIDED|90.0|0.45|0.61|||||Raltegravir+TUMS/Raltegravir only|||0.61|0.45|
71736060|NCT02473367|142986089|SUPERIORITY_OR_OTHER||GLSMR|0.42|||||TWO_SIDED|90.0|0.34|0.52|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only|||0.52|0.34|
71736061|NCT02473367|142986089|SUPERIORITY_OR_OTHER||GLSMR|0.43|||||TWO_SIDED|90.0|0.36|0.51|||||Raltegravir+12 Hrs TUMS/Raltegravir only|||0.51|0.36|
71736062|NCT02678923|142986090|SUPERIORITY||LS mean difference|0.73||||0.0738|TWO_SIDED|95.0|-0.07|1.52||Baseline parameter value as a covariate and treatment group as factor, adjusting for country and prior statin use.|ANCOVA|||||1.52|-0.07|0.0738
71773993|NCT01298531|143048069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.3291|TWO_SIDED|95.0|0.47|9.72|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.||9.72|0.47|0.3291
71660249|NCT04188301|142834846|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
71736063|NCT01641822|142986123|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.743||||0.25|TWO_SIDED|95.0|0.446|1.238|||Negative binomial regression|||Ratio between rates||1.238|0.446|0.25
71736064|NCT01641822|142986124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.16|TWO_SIDED|95.0|-0.55|3.2||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in FEV1 % predicted||3.2|-0.55|0.16
71773994|NCT01298531|143048070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.44|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.44|-1.11|<0.0001
71773995|NCT01298531|143048071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0011|TWO_SIDED|95.0|-1.09|-0.28|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.||-0.28|-1.09|0.0011
71736065|NCT01641822|142986125|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||Comparison of percentages||||0.67
71736066|NCT01641822|142986126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.71|TWO_SIDED|95.0|0.5|1.59|||Log Rank|||Comparison of time to exacerbation||1.59|0.50|0.71
71736067|NCT01641822|142986127|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.642||||0.14|TWO_SIDED|95.0|0.355|1.164|||Negative binomial regression|||Comparison of hospitalization rate||1.164|0.355|0.14
71736068|NCT01641822|142986128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06||||0.21|TWO_SIDED|95.0|-1.71|7.82||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in CFQ-R RSS||7.82|-1.71|0.21
71736069|NCT00454584|142986129|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
71736070|NCT00454584|142986129|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.|Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05. Sample Size: Assuming the PASI 75 response rates of ustekinumab 90 mg, 45 mg, etanercept are 65%, 64%, and 50% , respectively, with 325 participants each in the ustekinumab 90 mg and etanercept groups, the power to detect a treatment difference is 97%. With 200 participants in the ustekinumab 45 mg group, the complete power to further detect a treatment difference was 87%.||||0.012
71736071|NCT00454584|142986130|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
71736072|NCT00454584|142986130|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
71773996|NCT01298531|143048073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0011|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.24|-0.90|0.0011
71773997|NCT01298531|143048074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0037|TWO_SIDED|95.0|-1.11|-0.22|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.||-0.22|-1.11|0.0037
71736073|NCT00454584|142986131|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||||||<0.001
71736074|NCT00454584|142986131|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight \[\<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.||||<0.001
71736075|NCT00599638|142986137|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.306||0.391|TWO_SIDED|80.0|-0.31|0.48|||Mixed Models Analysis|||||0.48|-0.31|0.3910
71660250|NCT04188301|142834846|SUPERIORITY|IA vs IDA treatment groups for living female O. volvulus worms in nodules after treatment.|Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||||2.15|0.97|0.068
71736076|NCT00599638|142986137|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.357||0.0002|TWO_SIDED|80.0|-1.78|-0.86|||Mixed Models Analysis|||||-0.86|-1.78|0.0002
71736077|NCT00599638|142986138|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0055||||0.4959|TWO_SIDED|80.0|0.3|1.71|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||1.71|0.30|0.4959
71736078|NCT00599638|142986138|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.0763||||0.0011|TWO_SIDED|80.0|1.69|8.46|||Regression, Logistic|||The statistical analysis was performed compositely for all categories.||8.46|1.69|0.0011
71736079|NCT00599638|142986140|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|1.18|STANDARD_ERROR_OF_MEAN|2.819||0.338|TWO_SIDED|80.0|-2.47|4.84|||Mixed Models Analysis|||||4.84|-2.47|0.3380
71773998|NCT01298531|143048078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.40|-2.20|0.0050
71773999|NCT01298531|143048079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0256|TWO_SIDED|95.0|-2.33|-0.16|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.||-0.16|-2.33|0.0256
71736080|NCT00599638|142986140|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.65|STANDARD_ERROR_OF_MEAN|3.268||0.0022|TWO_SIDED|80.0|-13.89|-5.42|||Mixed Models Analysis|||||-5.42|-13.89|0.0022
71736081|NCT01532869|142986152|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) mean|-2.7||||0.0915|TWO_SIDED|95.0|-5.85|0.45|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.45|-5.85|0.0915
71736082|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.43||||0.9336|TWO_SIDED|95.0|-10.78|9.91|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.91|-10.78|0.9336
71736083|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.12||||0.4609|TWO_SIDED|95.0|-15.21|6.96|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.96|-15.21|0.4609
71736084|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.28||||0.8493|TWO_SIDED|95.0|-14.7|12.13|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.13|-14.70|0.8493
71736085|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|4.89||||0.4717|TWO_SIDED|95.0|-8.59|18.37|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||18.37|-8.59|0.4717
71736086|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.08||||0.9876|TWO_SIDED|95.0|-9.93|9.78|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.78|-9.93|0.9876
71736087|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-6.8||||0.2407|TWO_SIDED|95.0|-18.3|4.71|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||4.71|-18.30|0.2407
71774000|NCT01298531|143048081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0474|TWO_SIDED|95.0|-2.0|-0.01|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.||-0.01|-2.00|0.0474
71774001|NCT01298531|143048082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0212|TWO_SIDED|95.0|-2.36|-0.2|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor||-0.20|-2.36|0.0212
71774002|NCT01298531|143048084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0198|TWO_SIDED|95.0|-2.4|-0.21|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.21|-2.40|0.0198
71774003|NCT01298531|143048085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0132|TWO_SIDED|95.0|-2.69|-0.32|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor||-0.32|-2.69|0.0132
71774004|NCT01298531|143048087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0237|TWO_SIDED|95.0|-1.5|-0.11|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.11|-1.50|0.0237
71889929|NCT02274688|143301708|SUPERIORITY||||||=|0.23|||||||Wald Chi-Square=4.25, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.23
71736088|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|1.54||||0.7742|TWO_SIDED|95.0|-9.18|12.26|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||12.26|-9.18|0.7742
71736089|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-4.48||||0.5182|TWO_SIDED|95.0|-18.28|9.31|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||9.31|-18.28|0.5182
71774005|NCT01298531|143048088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.0297|TWO_SIDED|95.0|-1.74|-0.09|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.||-0.09|-1.74|0.0297
71774006|NCT01298531|143048089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16||||0.0152|TWO_SIDED|95.0|-2.09|-0.23|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.23|-2.09|0.0152
71774007|NCT01298531|143048090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.0344|TWO_SIDED|95.0|-2.22|-0.09|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.||-0.09|-2.22|0.0344
71736090|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-5.8||||0.3106|TWO_SIDED|95.0|-17.2|5.59|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.59|-17.20|0.3106
71736091|NCT01532869|142986154|SUPERIORITY_OR_OTHER||Difference in LS mean|-7.82||||0.1717|TWO_SIDED|95.0|-19.11|3.48|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||3.48|-19.11|0.1717
71736092|NCT01532869|142986155|SUPERIORITY_OR_OTHER||Difference in LS mean|0.02||||0.8503|TWO_SIDED|95.0|-0.186|0.225|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction||0.225|-0.186|0.8503
71736093|NCT01532869|142986155|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.207||||0.1212|TWO_SIDED|95.0|-0.471|0.056|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.056|-0.471|0.1212
71736094|NCT01532869|142986156|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.99||||0.8118|TWO_SIDED|95.0|-9.2|7.23|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 24.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||7.23|-9.20|0.8118
71736095|NCT01532869|142986156|SUPERIORITY_OR_OTHER||Difference in LS mean|-9.02||||0.0768|TWO_SIDED|95.0|-19.04|1.0|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 48.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||1.00|-19.04|0.0768
71736096|NCT01532869|142986157|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.85||||0.4063|TWO_SIDED|95.0|-13.04|5.34|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.34|-13.04|0.4063
71736097|NCT01532869|142986157|SUPERIORITY_OR_OTHER||Difference in LS mean|-8.3||||0.1371|TWO_SIDED|95.0|-19.31|2.71|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.71|-19.31|0.1371
71736098|NCT01532869|142986158|SUPERIORITY_OR_OTHER||Difference in LS mean|1.43||||0.5197|TWO_SIDED|95.0|-2.97|5.82|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||5.82|-2.97|0.5197
71736099|NCT01532869|142986158|SUPERIORITY_OR_OTHER||Difference in LS mean|2.75||||0.1886|TWO_SIDED|95.0|-1.38|6.88|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||6.88|-1.38|0.1886
71736100|NCT01532869|142986159|SUPERIORITY_OR_OTHER||Difference in LS mean|0.79||||0.3651|TWO_SIDED|95.0|-0.94|2.51|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||2.51|-0.94|0.3651
71736101|NCT01532869|142986159|SUPERIORITY_OR_OTHER||Difference in LS mean|-1.11||||0.2841|TWO_SIDED|95.0|-3.16|0.94|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.94|-3.16|0.2841
71736102|NCT01532869|142986160|SUPERIORITY_OR_OTHER||Difference in LS mean|-3.55||||0.0579|TWO_SIDED|95.0|-7.23|0.12|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.||0.12|-7.23|0.0579
71774008|NCT01298531|143048092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0017|TWO_SIDED|95.0|-2.16|-0.52|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor||-0.52|-2.16|0.0017
71774009|NCT01298531|143048093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0233|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.||-0.16|-2.07|0.0233
71736103|NCT01532869|142986161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|STANDARD_ERROR_OF_MEAN|0.704||0.2159|TWO_SIDED|95.0|0.6|9.5|||Regression, Logistic|||The logistic regression model included the fixed categorical effects of treatment and the stratification factor of joint involvement at the baseline visit. The continuous covariate of baseline mRSS score was also included in the model.||9.50|0.60|0.2159
71774010|NCT01298531|143048102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.126|TWO_SIDED|95.0|0.822|4.901|||Regression, Logistic|||Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.||4.901|0.822|0.1260
71736104|NCT01424228|142986174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367|||||||Cochran-Mantel-Haenszel|||||||0.367
71832796|NCT00402246|143169745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.325|ONE_SIDED|95.0||1.43||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple ED visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.43||0.325
71736105|NCT04484207|142986197|SUPERIORITY|||||||0.031|||||||GEE|||||||0.031
71736106|NCT03037983|142986199|SUPERIORITY||Mean Difference (Net)|1.38||||0.849|TWO_SIDED||||||t-test, 2 sided|||||||.849
71660251|NCT04188301|142834846|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
71736107|NCT03037983|142986201|SUPERIORITY||Mean Difference (Net)|0.5||||0.782|TWO_SIDED|||||t = 0.287|t-test, 2 sided|||||||.782
71736108|NCT04118595|142986239|SUPERIORITY|||||||0.13|||||||ANCOVA|||||||0.13
71736109|NCT04118595|142986240|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
71736110|NCT04118595|142986241|SUPERIORITY|||||||0.08|||||||ANCOVA|||||||0.08
71736111|NCT04118595|142986242|SUPERIORITY|||||||0.64|||||||ANCOVA|||||||0.64
71736112|NCT04118595|142986243|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
71736113|NCT04118595|142986244|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
71736114|NCT04118595|142986245|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.19
71736115|NCT04118595|142986246|SUPERIORITY|||||||0.15|||||||ANCOVA|||||||0.15
71736116|NCT04118595|142986247|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71736117|NCT04118595|142986248|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
71736118|NCT00788710|142986278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71736119|NCT00788710|142986278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71736120|NCT00788710|142986279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71736121|NCT00788710|142986279|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71736122|NCT00788710|142986280|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71736123|NCT00788710|142986280|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71736124|NCT00006400|142986293|SUPERIORITY|The primary analysis was done using an intention-to-treat principle.||||||0.21||||||The spleen endpoint was to be tested at an overall alpha = 0.04. Originally there was a second primary outcome to be tested at alpha = 0.01, but this outcome was dropped.|Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or decreased to absent) and not worsening (from decreased to decreased, normal to normal, or decreased to normal) as measured by splenic uptake on a technetium-99m (99mTc) sulfur colloid liver-spleen scan. Children with missing data or absent spleen function at baseline were excluded from the analysis (26 subjects from hydroxyurea and 23 subjects from placebo group were excluded).||||0.21
71736125|NCT00006400|142986294|SUPERIORITY|||||||0.93||||||This was originally a second primary outcome to be tested at alpha = 0.01, but was later dropped from the protocol. We analyzed the available data.|ANOVA|||The change from baseline to exit as measured by DTPA GFR were compared between treatment groups.||||0.93
71736126|NCT00006400|142986295|SUPERIORITY|||||||0.43||||||All secondary outcomes were tested at alpha=0.01|ANOVA|||The change from baseline to exit as measured by GFR (calculated using Shwartz formula) were compared between treatment groups.||||0.43
71736127|NCT00006400|142986296|SUPERIORITY|||||||0.48||||||All secondary outcomes were to be tested at alpha = 0.01|ANOVA|||The change in GFR from baseline to exit were compared between treatment groups. GFR was calculated using new Schwartz formula.||||0.48
71736128|NCT00605345|142986310|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was met if the lower limit of the confidence interval for the response rate of the CERA group was greater than the observed response rate of the darbepoetin group minus 15%. The calculated lower limit of an acceptable difference in response rates thus, was based on the actual percentage of responders in the darbepoetin group and this percentage minus 15% had to be excluded."||||||0.5947|||||||Fisher Exact|||||||0.5947
71736129|NCT00422383|142986325|SUPERIORITY_OR_OTHER||Weighted Difference|-0.01||||0.8156|TWO_SIDED|95.0|-0.13|0.1|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.|||0.10|-0.13|0.8156
71736130|NCT00422383|142986325|SUPERIORITY_OR_OTHER||Weighted Difference|0.07||||0.2419|TWO_SIDED|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, RF status, and treatment.|||0.19|-0.05|0.2419
71736131|NCT00422383|142986328|SUPERIORITY_OR_OTHER|||||||0.7127|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.7127
71736132|NCT00422383|142986328|SUPERIORITY_OR_OTHER|||||||0.1018|TWO_SIDED|||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA|||||||0.1018
71736133|NCT00422383|142986329|SUPERIORITY_OR_OTHER|||||||0.5029|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.5029
71736134|NCT00422383|142986329|SUPERIORITY_OR_OTHER|||||||0.0495|TWO_SIDED|||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel|||||||0.0495
71736135|NCT03738618|142986373|OTHER||Treatment difference|43.3|||<|0.001|TWO_SIDED|95.0|36.5|47.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||47.6|36.5|<0.001
71736136|NCT03738618|142986374|OTHER||Treatment difference|22.0|||<|0.001|TWO_SIDED|95.0|14.9|25.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||25.7|14.9|<0.001
71660252|NCT04188301|142834849|SUPERIORITY||Odds Ratio (OR)|1.41||||0.192|TWO_SIDED|95.0|0.84|2.38||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA for living female O. volvulus worms in nodules after treatment.||2.38|0.84|0.192
71736137|NCT03738618|142986378|OTHER||Treatment difference|26.8|||<|0.001|TWO_SIDED|95.0|19.8|30.8|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||30.8|19.8|<0.001
71736138|NCT03738618|142986378|OTHER||Treatment difference|52.0|||<|0.001|TWO_SIDED|95.0|44.9|56.3|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||56.3|44.9|<0.001
71736139|NCT03738618|142986379|OTHER||Treatment difference|23.5|||<|0.001|TWO_SIDED|95.0|16.7|27.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||27.2|16.7|<0.001
71736140|NCT03738618|142986379|OTHER||Treatment difference|45.6|||<|0.001|TWO_SIDED|95.0|38.5|49.9|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||49.9|38.5|<0.001
71736141|NCT03738618|142986381|OTHER||Treatment difference|32.1|||<|0.001|TWO_SIDED|95.0|24.9|36.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||36.2|24.9|<0.001
71736142|NCT03738618|142986381|OTHER||Treatment difference|58.9|||<|0.001|TWO_SIDED|95.0|51.9|63.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||63.0|51.9|<0.001
71736143|NCT03738618|142986393|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71736144|NCT03738618|142986394|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71736145|NCT03738618|142986395|OTHER|||||||0.19|||||||Fisher Exact|||||||0.190
71736146|NCT03738618|142986396|OTHER|||||||0.396|||||||Fisher Exact|||||||0.396
71736147|NCT00649428|142986442|SUPERIORITY_OR_OTHER|||||||1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||.00001
71736148|NCT00649428|142986445|SUPERIORITY_OR_OTHER||||||<|1e-05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.||||<.00001
71736149|NCT04566601|142986462|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.7||||0.4994|TWO_SIDED|95.0|-1.31|2.69||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||2.69|-1.31|0.4994
71736150|NCT04566601|142986462|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.6||||0.6014|TWO_SIDED|95.0|-2.6|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.51|-2.60|0.6014
71736151|NCT04566601|142986462|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.2||||0.8166|TWO_SIDED|95.0|-2.17|1.72||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.72|-2.17|0.8166
71736152|NCT04566601|142986462|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.4||||0.6588|TWO_SIDED|95.0|-1.96|1.24||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95 % confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS means differences (95 % confidence intervals) for Week 10 are reported.||1.24|-1.96|0.6588
71774011|NCT01298531|143048105|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.0498|TWO_SIDED|95.0|1.0|6.08|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.||6.08|1.00|0.0498
71774012|NCT01298531|143048107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1601|TWO_SIDED|95.0|-0.87|0.15|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.15|-0.87|0.1601
71774013|NCT01298531|143048108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2967|TWO_SIDED|95.0|-0.86|0.27|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor||0.27|-0.86|0.2967
71736153|NCT04566601|142986462|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.3914|||||||MCP-Mod sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg, and 90% of the maximum effect is achieved at 75 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.3914
71736154|NCT04566601|142986462|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10 and 12) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4104|||||||MCP-Mod Emax1 model fit|Model assumption: 50% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4104
71736155|NCT04566601|142986462|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.456|||||||MCP-Mod linear model fit|Model assumption: No parameter assumptions required.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4560
71736156|NCT04566601|142986462|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4908|||||||MCP-Mod exponential model fit|Model assumption: 5% of the maximum effect is achieved at 25 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4908
71736157|NCT04566601|142986462|OTHER|MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction.||||||0.4974|||||||MCP-Mod Emax2 model fit|Model assumption: 70% of the maximum effect is achieved at 5 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).||||0.4974
71736158|NCT04566601|142986463|OTHER||Odds Ratio (OR)|0.486|||||TWO_SIDED|95.0|0.207|1.14|||||Odds Ratio of BI 1358894 5mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||1.140|0.207|
71736159|NCT04566601|142986463|OTHER||Odds Ratio (OR)|2.294|||||TWO_SIDED|95.0|0.829|7.48|||||Odds Ratio of BI 1358894 25mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||7.480|0.829|
71736160|NCT04566601|142986463|OTHER||Odds Ratio (OR)|1.753|||||TWO_SIDED|95.0|0.698|4.861|||||Odds Ratio of BI 1358894 75mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||4.861|0.698|
71736161|NCT04566601|142986463|OTHER||Odds Ratio (OR)|1.352|||||TWO_SIDED|95.0|0.642|2.913|||||Odds Ratio of BI 1358894 125mg vs. Placebo.|The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.||2.913|0.642|
71889930|NCT02274688|143301709|SUPERIORITY||||||=|0.55|||||||Wald Chi-Square=2.12, df=3, p=0.55|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.55
71660253|NCT04188301|142834849|SUPERIORITY||Odds Ratio (OR)|1.45||||0.107|TWO_SIDED|95.0|0.92|2.29||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for living female O. volvulus worms in nodules after treatment.||2.29|0.92|0.107
71736162|NCT04566601|142986464|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.1||||0.9675|TWO_SIDED|95.0|-5.11|4.9||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.90|-5.11|0.9675
71736163|NCT04566601|142986464|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.01||||0.9969|TWO_SIDED|95.0|-5.08|5.1||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.10|-5.08|0.9969
71736164|NCT04566601|142986464|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.79||||0.7542|TWO_SIDED|95.0|-5.73|4.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.15|-5.73|0.7542
71736165|NCT04566601|142986464|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.17||||0.5683|TWO_SIDED|95.0|-2.86|5.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.19|-2.86|0.5683
71736166|NCT04566601|142986465|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-2.07||||0.3568|TWO_SIDED|95.0|-6.49|2.35||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.35|-6.49|0.3568
71736167|NCT04566601|142986465|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.21||||0.6009|TWO_SIDED|95.0|-3.33|5.75||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||5.75|-3.33|0.6009
71736168|NCT04566601|142986465|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.36||||0.8705|TWO_SIDED|95.0|-4.7|3.98||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||3.98|-4.70|0.8705
71736169|NCT04566601|142986465|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|1.15||||0.5262|TWO_SIDED|95.0|-2.41|4.71||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||4.71|-2.41|0.5262
71736170|NCT04566601|142986466|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-1.83||||0.0782|TWO_SIDED|95.0|-3.87|0.21||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.21|-3.87|0.0782
71832797|NCT00402246|143169745|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.099|ONE_SIDED|95.0||1.31||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.||1.31||0.099
71736171|NCT04566601|142986466|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|0.23||||0.8266|TWO_SIDED|95.0|-1.86|2.32||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||2.32|-1.86|0.8266
71832798|NCT00402246|143169746|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.29|ONE_SIDED|95.0||2.56||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|||An Andersen-Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.||2.56||0.29
71832799|NCT00402246|143169749|SUPERIORITY_OR_OTHER||probability|0.23||||||95.0|||||Regression, Logistic|A GEE model was utilized to account for multiple events within same patient in estimating the probability of an AT/AF alert event being symptomatic.||||||
71736172|NCT04566601|142986466|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.27||||0.791|TWO_SIDED|95.0|-2.28|1.74||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.74|-2.28|0.7910
71774014|NCT01298531|143048114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.41||||0.2735|TWO_SIDED|95.0|-1.94|6.75|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||6.75|-1.94|0.2735
71774015|NCT01298531|143048115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.0422|TWO_SIDED|95.0|0.02|1.34|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.||1.34|0.02|0.0422
71774016|NCT00760214|143048140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-11.04|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-5.78|-11.04|<.001
71774017|NCT00760214|143048140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.03|||<|0.001|TWO_SIDED|95.0|-11.66|-6.39||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-6.39|-11.66|<.001
71774018|NCT00760214|143048141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31|||<|0.001|TWO_SIDED|95.0|-6.85|-3.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.78|-6.85|<.001
71774019|NCT00760214|143048141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.66|||<|0.001|TWO_SIDED|95.0|-7.21|-4.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.12|-7.21|<.001
71774020|NCT00760214|143048142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.82|||<|0.001|TWO_SIDED|95.0|-7.64|-2.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.01|-7.64|<.001
71774021|NCT00760214|143048142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.47||||0.002|TWO_SIDED|95.0|-7.27|-1.66||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.66|-7.27|0.002
71774022|NCT00760214|143048143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.77||||0.003|TWO_SIDED|95.0|-4.61|-0.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.94|-4.61|0.003
71774023|NCT00760214|143048143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06||||0.001|TWO_SIDED|95.0|-4.89|-1.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.24|-4.89|0.001
71774024|NCT00760214|143048144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.017|TWO_SIDED|95.0|-6.87|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-6.87|0.017
71774025|NCT00760214|143048144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.43||||0.029|TWO_SIDED|95.0|-6.5|-0.36||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.36|-6.50|0.029
71774026|NCT00760214|143048145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.052|TWO_SIDED|95.0|-4.15|0.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||0.02|-4.15|0.052
71774027|NCT00760214|143048145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42||||0.022|TWO_SIDED|95.0|-4.49|-0.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.35|-4.49|0.022
71774028|NCT00760214|143048146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.003|TWO_SIDED|95.0|-7.46|-1.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.59|-7.46|0.003
71774029|NCT00760214|143048146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.26||||0.004|TWO_SIDED|95.0|-7.18|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.35|-7.18|0.004
71889931|NCT02274688|143301710|SUPERIORITY||||||=|0.32|||||||Wald Chi-Square=3.52, df=3; p=0.32|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.32
71889932|NCT02274688|143301711|SUPERIORITY||||||=|0.26|||||||Wald Chi-Square=4.02, df=3, p=0.26|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.26
71736173|NCT04566601|142986466|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.8743|TWO_SIDED|95.0|-1.77|1.51||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||1.51|-1.77|0.8743
71736174|NCT04566601|142986467|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.05||||0.8016|TWO_SIDED|95.0|-0.47|0.37||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.37|-0.47|0.8016
71736175|NCT04566601|142986467|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.23||||0.2929|TWO_SIDED|95.0|-0.67|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.67|0.2929
71736176|NCT04566601|142986467|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.01||||0.9666|TWO_SIDED|95.0|-0.42|0.4||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.40|-0.42|0.9666
71736177|NCT04566601|142986467|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.18||||0.2833|TWO_SIDED|95.0|-0.52|0.15||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.15|-0.52|0.2833
71736178|NCT04566601|142986468|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4552|TWO_SIDED|95.0|-0.45|0.2||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 5mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.20|-0.45|0.4552
71774030|NCT00760214|143048147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.64||||0.008|TWO_SIDED|95.0|-4.6|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.68|-4.60|0.008
71774031|NCT00760214|143048147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.98||||0.003|TWO_SIDED|95.0|-4.93|-1.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.04|-4.93|0.003
71774032|NCT00760214|143048148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|||<|0.001|TWO_SIDED|95.0|-9.12|-2.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.77|-9.12|<.001
71774033|NCT00760214|143048148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||<|0.001|TWO_SIDED|95.0|-8.96|-2.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.67|-8.96|<.001
71774034|NCT00760214|143048149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.01||||0.006|TWO_SIDED|95.0|-5.15|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-0.88|-5.15|0.006
71889933|NCT02274688|143301712|SUPERIORITY||||||=|0.22|||||||Wald Chi-Square=4.44, df=3, p=0.22|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.22
71736179|NCT04566601|142986468|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.13||||0.4734|TWO_SIDED|95.0|-0.47|0.22||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 25mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.22|-0.47|0.4734
71736180|NCT04566601|142986468|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.03||||0.8388|TWO_SIDED|95.0|-0.36|0.29||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 75mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.29|-0.36|0.8388
71736181|NCT04566601|142986468|OTHER|No formal hypotheses were tested.|Mean Difference (Net)|-0.08||||0.554|TWO_SIDED|95.0|-0.35|0.19||P-value is considered nominal.|Mixed effects model repeated measures||"Least Squares Mean of BI 1358894 125mg - Least Squares Mean of Placebo."|Least Squares (LS) mean difference and 95% confidence interval were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.||0.19|-0.35|0.5540
71736182|NCT02277925|142986472|SUPERIORITY||Risk Ratio (RR)|1.74||||0.3|TWO_SIDED|95.0|0.59|5.14|||Chi-squared|||||5.14|0.59|0.30
71736183|NCT02277925|142986473|SUPERIORITY||Risk Ratio (RR)|1.03||||0.43|TWO_SIDED|95.0|0.96|1.11|||Chi-squared|||||1.11|0.96|0.43
71736184|NCT02277925|142986474|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.39|TWO_SIDED|95.0|-14.7|5.7|||t-test, 2 sided|||||5.7|-14.7|0.39
71736185|NCT01272635|142986475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.98|||Discrete time survival analysis||Hazard ratio: Numerator is Azithromycin and Denominator is Placebo|||0.98|0.41|0.04
71736186|NCT00183625|142986511|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
71736187|NCT00183625|142986512|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||The p-value listed is for the medication by time interaction.|Mixed Models Analysis|||Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.||||.0176
71736188|NCT04856904|142986573|SUPERIORITY||Bilateral difference|-3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-4.4|-2.0|||Student's t-test for paired samples|||||-2|-4.4|< 0.0001
71736189|NCT04856904|142986574|SUPERIORITY||Bilateral difference|0.0|STANDARD_ERROR_OF_MEAN|0.14|=|0.9476|TWO_SIDED|95.0|-0.3|0.3|||Student's t-test for paired samples|||Week 1: Trifarotene 50 mcg/g, vehicle cream||0.3|-0.3|= 0.9476
71736190|NCT04856904|142986574|SUPERIORITY||Bilateral difference|-0.6|STANDARD_ERROR_OF_MEAN|0.25|=|0.0248|TWO_SIDED|95.0|-1.1|-0.1|||Student's t-test for paired samples|||Week 2: Trifarotene 50 mcg/g, vehicle cream||-0.1|-1.1|= 0.0248
71736191|NCT04856904|142986574|SUPERIORITY||Bilateral difference|-0.8|STANDARD_ERROR_OF_MEAN|0.29|=|0.0072|TWO_SIDED|95.0|-1.4|-0.2|||Student's t-test for paired samples|||Week 4: Trifarotene 50 mcg/g, vehicle cream||-0.2|-1.4|= 0.0072
71774035|NCT00760214|143048149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||<|0.001|TWO_SIDED|95.0|-5.89|-1.65||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-1.65|-5.89|<.001
71736192|NCT04856904|142986574|SUPERIORITY||Bilateral difference|-1.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.1|-0.7|||Student's t-test for paired samples|||Week 8: Trifarotene 50 mcg/g, vehicle cream||-0.7|-2.1|< 0.0001
71736193|NCT04856904|142986574|SUPERIORITY||Bilateral difference|-2.1|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.9|-1.3|||Student's t-test for paired samples|||Week 12: Trifarotene 50 mcg/g, vehicle cream||-1.3|-2.9|< 0.0001
71736194|NCT04856904|142986574|SUPERIORITY||Bilateral difference|-2.7|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED|95.0|-3.8|-1.6|||Student's t-test for paired samples|||Week 16: Trifarotene 50 mcg/g, vehicle cream||-1.6|-3.8|< 0.0001
71736195|NCT04856904|142986574|SUPERIORITY||Bilateral difference|-2.5|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Student's t-test for paired samples|||Week 20: Trifarotene 50 mcg/g, vehicle cream||-1.5|-3.5|< 0.0001
71736196|NCT00454181|142986620|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.||||0.30
71736197|NCT00454181|142986621|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response||||0.26
71736198|NCT00454181|142986622|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as better."||||0.50
71736199|NCT00454181|142986623|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as better."||||0.29
71736200|NCT00454181|142986624|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with respect to changes in oral warts from baseline to week 24 by the attending investigator."||||0.74
71736201|NCT00454181|142986625|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with resepect to changes from baseline to week 24 in global oral health by the attending investigator."||||.71
71774036|NCT00760214|143048150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.87|||<|0.001|TWO_SIDED|95.0|-12.15|-5.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-5.60|-12.15|<.001
71889934|NCT02274688|143301713|SUPERIORITY||||||=|0.08||||||F(3,507)=2.24, P=0.08|Regression Poisson|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||=0.08
71736202|NCT04783077|142986630|SUPERIORITY||Odds Ratio (OR)|2.28||||0.23|TWO_SIDED|95.0|0.61|8.5|||Regression, Logistic||The estimated odds ratio of return donation attempt represents WhatsApp compared to control.|The primary analysis applies only to the RCT participants (N=130). Docudrama participants were not assessed for return blood donation. Analysis used fitted logistic regression with outcome donation attempted (Y/N) on the modiﬁed intention-to-treat (mITT) population, adjusted for type of donor (FRD, VNRBD).|Missing data on the primary outcome from the mITT analysis was handled using multiple imputation via chained equations with 50 imputations, and included stratum, group assignment (WhatsApp, Control) and ethnicity. Ethnicity was the only baseline variable with a minimum Kendall's tau of 0.2 with donation attempt.|8.50|0.61|0.23
71736203|NCT03045341|142986631|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
71736204|NCT03045341|142986631|SUPERIORITY|Analyses used all available data.||||||0.58|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.58
71889935|NCT02274688|143301714|SUPERIORITY|||||||0.36|||||||Wald Chi-Square=3.24, df=3, p=0.36|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."||||0.36
71736205|NCT03045341|142986632|SUPERIORITY|Analyses used all available data.||||||0.0001|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||BWL versus no BWL||||0.0001
71736206|NCT03045341|142986632|SUPERIORITY|Analyses used all available data.||||||0.63|||||||Mixed Models Analysis|Analyses to compare treatments were all intent-to-treat. Analyses were performed for all randomized patients who attended the first treatment session.||NB versus placebo||||0.63
71736207|NCT03045341|142986633|SUPERIORITY|||||||0.004|||||||Chi-squared|||Analyses used all available data.||||.004
71736208|NCT00849862|142986654|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.0|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||100|85.0|
71736209|NCT00849862|142986655|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.0||||||90.0|96.3|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|96.3|
71736210|NCT00849862|142986656|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.6||||||90.0|96.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||103|96.2|
71736211|NCT01727336|142986657|OTHER||recommended dose for Part 2|0.9|||||TWO_SIDED||||||||The recommended dose level for Part 2 was determined to be 0.9 mg/kg|||||
71736212|NCT02772978|142986688|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale, non-planning subscale.||||0.04
71736213|NCT02772978|142986689|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|||||||< 0.05
71736214|NCT02540993|142986731|SUPERIORITY||Hazard Ratio (HR)|0.825|||=|0.0014|TWO_SIDED|95.0|0.732|0.928||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.03282695.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.928|0.732|= 0.0014
71736215|NCT02540993|142986732|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.0339|TWO_SIDED|95.0|0.747|0.989||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.989|0.747|= 0.0339
71774037|NCT00760214|143048150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.46|-4.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-4.95|-11.46|<.001
71774038|NCT00760214|143048151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.68|||<|0.001|TWO_SIDED|95.0|-8.19|-3.17||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-3.17|-8.19|<.001
71774039|NCT00760214|143048151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.32|||<|0.001|TWO_SIDED|95.0|-7.81|-2.82||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA|||||-2.82|-7.81|<.001
71774040|NCT02545075|143048162|SUPERIORITY|||||||0.5059|||||||Chi-squared|One-sided p-value based on unstratified chi-square test||||||0.5059
71774041|NCT02545075|143048163|SUPERIORITY|||||||0.6202|||||||Chi-squared|One-sided unstratified chi-square||||||0.6202
71774042|NCT02545075|143048164|SUPERIORITY||Stratified cox proportional hazard model|1.13||||0.7267|TWO_SIDED|80.0|0.87|1.45|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)||||1.45|0.87|0.7267
71774043|NCT02545075|143048165|SUPERIORITY||Stratified Cox proportional hazard|0.9||||0.2503|TWO_SIDED|80.0|0.71|1.15|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS||||1.15|0.71|0.2503
71774044|NCT02545075|143048166|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|80.0|0.64|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.64|0.9932
71736216|NCT02540993|142986733|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.895|||=|0.2348|TWO_SIDED|95.0|0.746|1.075||P-value from stratified log-rank test. Significance was considered to be achieved if p-value ≤ 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.075|0.746|= 0.2348
71736217|NCT02540993|142986734|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.946|||=|0.1623|TWO_SIDED|95.0|0.876|1.022||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.022|0.876|= 0.1623
71736218|NCT02540993|142986735|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Ratio of least squares means|0.688|||<|0.0001|TWO_SIDED|95.0|0.662|0.715||P-value from F-test of equal means between the treatment groups.|ANCOVA|||||0.715|0.662|< 0.0001
71736219|NCT02540993|142986736|SUPERIORITY|If treatment effect on both primary and key secondary endpoint is significant, other secondary efficacy endpoints (i.e. all-cause mortality, all-cause hospitalization, change in UACR from baseline to Month 4, and secondary renal composite endpoint) will be tested hierarchically, starting with all-cause mortality. If treatment effect on all-cause mortality was not significant, all other endpoints would be tested in an exploratory manner.|Hazard Ratio (HR)|0.763|||=|0.0012|TWO_SIDED|95.0|0.648|0.9||P-value from stratified log-rank test.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.900|0.648|= 0.0012
71736220|NCT01009086|142986745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736221|NCT01009086|142986745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736222|NCT01009086|142986745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736223|NCT01009086|142986746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736224|NCT01009086|142986746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736225|NCT01009086|142986746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736226|NCT01009086|142986747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736227|NCT01009086|142986747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736228|NCT01009086|142986747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736229|NCT01009086|142986748|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736230|NCT01009086|142986748|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736231|NCT01009086|142986748|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736232|NCT01009086|142986749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736233|NCT01009086|142986749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736234|NCT01009086|142986749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736235|NCT01009086|142986750|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
71736236|NCT01009086|142986750|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736237|NCT01009086|142986750|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71736238|NCT01192828|142986756|OTHER|Descriptive analysis||||||0.235|||||||t-test, 2 sided|paired||Null hypothesis applied.||||0.235
71736239|NCT01192828|142986757|OTHER|Descriptive analysis.||||||0.701|||||||t-test, 2 sided|paired||Null hypothesis assumed.||||0.701
71736240|NCT01192828|142986758|OTHER|Descriptive analysis.||||||0.19|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.190
71736241|NCT01192828|142986759|OTHER|Descriptive analysis.||||||0.052|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.052
71736242|NCT01192828|142986760|OTHER|Descriptive analysis.||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed.||||0.014
71736243|NCT01192828|142986762|OTHER|Descriptive analysis||||||0.541|||||||Spearman's rank correlation|||Null hypothesis assumed|Spearman's rank correlation rho is 0.179, with p value 0.541, N is 14|||.541
71736244|NCT01192828|142986764|OTHER|Descriptive analysis||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.014
71736245|NCT01192828|142986765|OTHER|Descriptive analysis||||||0.012|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed||||0.012
71736246|NCT01192828|142986766|OTHER|Descriptive analysis.||||||0.16|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.||||0.160
71736247|NCT01192828|142986767|OTHER|Descriptive analysis||||||0.1|||||||t-test, 2 sided|||||||0.10
71736248|NCT00590577|142986768|SUPERIORITY_OR_OTHER||Difference in least-squares means|-9.8|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-13.71|-5.85||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-5.85|-13.71|<0.001
71889936|NCT00951821|143301719|SUPERIORITY_OR_OTHER||Slope|-3.3||||0.46|TWO_SIDED|95.0|-12.1|5.5||Effect sizes were also calculated due to small sample size|Mixed Models Analysis||The reported statistic (-3.3) is the difference in the change from baseline to follow-up between the two treatment arms, estimated in a mixed effect regression model.|||5.5|-12.1|.46
71889937|NCT00951821|143301720|SUPERIORITY_OR_OTHER||Slope|0.4||||0.75|TWO_SIDED|95.0|-2.36|3.06|||Mixed Models Analysis||The statistic provided (0.4) is the difference in the change in BDI score from baseline to follow-up by treatment group.|||3.06|-2.36|.75
71889938|NCT00391599|143301732|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Chi-squared|||||||0.15
71889939|NCT00391599|143301734|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71889940|NCT03124459|143301752|SUPERIORITY||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|5.2||0.01|TWO_SIDED|90.0|4.9|22.1|||ANCOVA|||||22.1|4.9|0.01
71889941|NCT03124459|143301753|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|2.2||0.16|TWO_SIDED|90.0|-6.8|0.6|||ANCOVA|||||0.6|-6.8|0.16
71889942|NCT03124459|143301754|SUPERIORITY||Mean Difference (Final Values)|35.4|STANDARD_ERROR_OF_MEAN|23.5||0.13|TWO_SIDED|90.0|-3.2|74.0|||ANCOVA|||||74|-3.2|0.13
71736249|NCT00590577|142986768|SUPERIORITY_OR_OTHER||Difference in least-squares means|-8.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.001||95.0|-12.62|-4.78||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-4.78|-12.62|<0.001
71774045|NCT02545075|143048167|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9738|TWO_SIDED|80.0|0.48|2.03|||Cochran-Mantel-Haenszel|||||2.03|0.48|0.9738
71889943|NCT03124459|143301755|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.5||0.73|TWO_SIDED|90.0|-7.1|10.9|||ANCOVA|||||10.9|-7.1|0.73
71889944|NCT03124459|143301756|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.7||0.51|TWO_SIDED|90.0|-4.6|10.9|||ANCOVA|||||10.9|-4.6|0.51
71774046|NCT00736879|143048170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1672|<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||Tested at alpha=0.019 applying Dunnett's adjustment|ANCOVA|||||-0.37|-1.02|<0.0001
71774047|NCT00736879|143048170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.1679|<|0.0001|TWO_SIDED|95.0|-1.07|-0.41|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.41|-1.07|<0.0001
71889945|NCT03124459|143301761|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|3.9||0.63|TWO_SIDED|90.0|-8.4|4.6|||ANCOVA|||||4.6|-8.4|0.63
71889946|NCT03051633|143301795|SUPERIORITY|Event: Dichotimized self-reported first-time alcohol use in known participant history prior to data-collection, where substance use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If substance use was reported, censoring indicator indicates the risk period|Hazard Ratio (HR)|-0.42||||0.004|TWO_SIDED|95.0|-0.714|-0.126|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol use during a given measurement period, given that students did not use alchohol in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake by the end of their eighth-grade year, relative to students attending control schools.||-0.126|-0.714|.004
71889947|NCT03051633|143301796|SUPERIORITY|Event: dichotimized self-reported first-time alcohol intoxication in known participant history prior to data collection, where intoxication was not reported in prior measurement occasions. Episodes: Represent the period of time between measurement occasions, thus, each episode represents the measured period of time between each assessment wave. Censoring: Indicates the risk period during which particpants experienced intoxication uptake.|Hazard Ratio, log|-0.39||||0.037|TWO_SIDED|95.0|-0.762|-0.018|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ration rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time alcohol initiation during a given measurement period, given that students did not become intoxicated in a previous measurement period. Thus, for each model, we tested the following hypothesis: controlling for age at first assessment, students attending BUYOI-assigned schools will have a lower risk of substance use uptake at the end of their eight grade year||-0.018|-0.762|.037
71889948|NCT03051633|143301797|SUPERIORITY|Event: Dichotimized self-reported first-time marijuana use in known participant history prior to data-collection, where marijuana use was not previously reported in prior measurement occasions of this four-wave longitudinal study. Episodes: Episodes represent the period of time between measurement occasions, as such, each episode represents the measured period of time between each wave of assessments. Censoring: If marijuana use was reported, censoring indicator indicates the risk period.|Hazard Ratio, log|0.17||||0.228|TWO_SIDED|95.0|-0.104|0.444|||Regression, Logistic|Discrete time hazard model represents a survival analysis, with the outcome parameters reflecting a hazard ratio rather than odds.||Discrete time hazard represents the conditional probability that a student will experience first time marijuana use during a given measurement period, given that students did not use marijuana in a previous measurement period. Thus for each model, we tested the following hypothesis: Controlling for age at first-assessment, students attending BUYOI-assigned schools will have a lower risk of marijuana use uptake by the end of their eighth-grade year, relative to students attending control schools.||0.444|-0.104|0.228
71889949|NCT03575104|143301809|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-11.62||||0.0001|TWO_SIDED|95.0|-17.604|-5.633||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).||-5.633|-17.604|0.0001
71736250|NCT00590577|142986768|SUPERIORITY_OR_OTHER||Difference in least-squares means|-5.1|STANDARD_ERROR_OF_MEAN|2.01||0.034||95.0|-9.01|-1.1||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett's method in each family of hypotheses and using Bonferroni's inequality between different families.||-1.10|-9.01|0.034
71736251|NCT00590577|142986769|SUPERIORITY_OR_OTHER||Difference in least-squares means|6.2|STANDARD_ERROR_OF_MEAN|1.49|<|0.001||95.0|3.26|9.12||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||9.12|3.26|<0.001
71736252|NCT00590577|142986769|SUPERIORITY_OR_OTHER||Difference in least-squares means|4.4|STANDARD_ERROR_OF_MEAN|1.5||0.007||95.0|1.43|7.31||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||7.31|1.43|0.007
71736253|NCT00590577|142986769|SUPERIORITY_OR_OTHER||Difference in least-squares means|1.0|STANDARD_ERROR_OF_MEAN|1.5||0.509||95.0|-1.96|3.95||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.||3.95|-1.96|0.509
71736254|NCT00590577|142986770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
71736255|NCT00590577|142986770|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.005
71736256|NCT00590577|142986770|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.140
71736257|NCT01229449|142986777|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71736258|NCT01229449|142986777|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71736259|NCT01229449|142986777|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
71736260|NCT01229449|142986777|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
71736261|NCT01229449|142986777|SUPERIORITY|||||||0.72|||||||ANOVA|||||||0.72
71736262|NCT01229449|142986777|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71736263|NCT01229449|142986777|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71736264|NCT01229449|142986777|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71736265|NCT01229449|142986777|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71736266|NCT01229449|142986777|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71736267|NCT03274518|142986851|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.4534|||||||t-test, 2 sided|||||||0.4534
71736268|NCT03274518|142986852|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.1179|||||||t-test, 2 sided|||||||0.1179
71736269|NCT03274518|142986853|NON_INFERIORITY|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.3054|||||||t-test, 2 sided|||||||0.3054
71736270|NCT03274518|142986854|NON_INFERIORITY|The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)||||||0.045|||||||t-test, 2 sided|||||||0.045
71736271|NCT03916484|142986864|OTHER|||||||0.33||||||No a priori threshold for statistical significance was specified.|Kruskal-Wallis|||||||0.33
71736272|NCT03916484|142986865|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71736273|NCT03916484|142986865|OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71736274|NCT03916484|142986865|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71736275|NCT03916484|142986865|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71736276|NCT03916484|142986865|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71736277|NCT03916484|142986866|OTHER|||||||0.45||||||No a priori threshold for statistical significance was specified.|Fisher Exact|||||||0.45
71736278|NCT03916484|142986867|OTHER||||||<|0.001|||||||McNemar|||||||<0.001
71736279|NCT03916484|142986867|OTHER|||||||0.07|||||||McNemar|||||||0.07
71736280|NCT03916484|142986867|OTHER|||||||0.003|||||||McNemar|||||||0.003
71736281|NCT03916484|142986868|OTHER|||||||0.25|||||||McNemar|||||||0.25
71736282|NCT03916484|142986868|OTHER|||||||0.002|||||||McNemar|||||||0.002
71736283|NCT03916484|142986868|OTHER|||||||0.453|||||||McNemar|||||||0.453
71736284|NCT03916484|142986868|OTHER|||||||0.5|||||||McNemar|||||||0.500
71736285|NCT03916484|142986868|OTHER|||||||0.003|||||||McNemar|||||||0.003
71736286|NCT01769196|142986869|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.13||||0.329|TWO_SIDED|95.0|0.88|1.45|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||1.45|0.88|0.329
71660254|NCT04188301|142834849|SUPERIORITY||Odds Ratio (OR)|1.44||||0.068|TWO_SIDED|95.0|0.97|2.15||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA groups for living female O. volvulus worms in nodules after treatment.||2.15|0.97|0.068
71736287|NCT01769196|142986870|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.03||||0.851|TWO_SIDED|95.0|0.74|1.43|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||1.43|0.74|0.851
71736288|NCT01769196|142986871|SUPERIORITY|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.2||||0.475|TWO_SIDED|95.0|0.72|2.0|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.00|0.72|0.475
71736289|NCT01769196|142986872|OTHER||Hazard Ratio (HR)|1.2||||0.602|TWO_SIDED|95.0|0.61|2.37|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.|||2.37|0.61|0.602
71736290|NCT01769196|142986873|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.99||||0.988|TWO_SIDED|95.0|0.43|2.28|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.28|0.43|0.988
71736291|NCT01769196|142986874|OTHER|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.95||||0.925|TWO_SIDED|95.0|0.3|2.99|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.|||2.99|0.30|0.925
71736292|NCT00655629|142986884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.92|||<|0.0001||95.0|-8.45|-5.38|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.38|-8.45|<0.0001
71736293|NCT00655629|142986885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.972|||<|0.0001||95.0|-32.688|-19.256|||ANCOVA|||Statistical analysis applies to the total population.||-19.256|-32.688|<0.0001
71736294|NCT00655629|142986886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.432|||<|0.0001||95.0|-40.439|-26.425|||ANCOVA|||Statistical analysis applies to the total population.||-26.425|-40.439|<0.0001
71736295|NCT00655629|142986887|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|53.8693|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
71736296|NCT00655629|142986888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.078|||<|0.0001||95.0|-22.41|-9.746|||ANCOVA|||Statistical analysis applies to the total population.||-9.746|-22.41|<0.0001
71736297|NCT00655629|142986889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.134|||<|0.0001||95.0|-40.281|-25.987|||ANCOVA|||Statistical analysis applies to the total population.||-25.987|-40.281|<0.0001
71736298|NCT00655629|142986890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.934|||<|0.0001||95.0|-41.119|-26.749|||ANCOVA|||Statistical analysis applies to the total population.||-26.749|-41.119|<0.0001
71736299|NCT00655629|142986891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.902|||<|0.0001||95.0|-27.724|-14.081|||ANCOVA|||Statistical analysis applies to the total population.||-14.081|-27.724|<0.0001
71736300|NCT00655629|142986893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.866|||<|0.0001||95.0|-22.599|-11.133|||ANCOVA|||Statistical analysis applies to the total population.||-11.133|-22.599|<0.0001
71736301|NCT00655629|142986894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.04|||<|0.0001||95.0|-31.547|-20.533|||ANCOVA|||Statistical analysis applies to the total population.||-20.533|-31.547|<0.0001
71736302|NCT00655629|142986895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.496|||<|0.0001||95.0|-24.676|-14.315|||ANCOVA|||Statistical analysis applies to the total population.||-14.315|-24.676|<0.0001
71832800|NCT00402246|143169751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|4.3||0.779|TWO_SIDED|95.0|-0.8|1.0||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||1.0|-0.8|0.779
71832801|NCT00402246|143169752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_DEVIATION|19.1|<|0.001|TWO_SIDED|95.0|-13.1|-6.9||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.||-6.9|-13.1|<0.001
71832802|NCT00402246|143169753|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82||||0.002|TWO_SIDED|95.0|0.7|0.9||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.|negative binomial model|||The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.||0.9|0.7|0.002
71832803|NCT00402246|143169754|SUPERIORITY_OR_OTHER||compliance rate|0.761|||||ONE_SIDED|95.0|0.737||||Binomial Exact Test|||3-month compliance rate|||0.737|
71832804|NCT00402246|143169754|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.793||||Binomial Exact Test|||6-month compliance rate|||0.793|
71832805|NCT00402246|143169754|SUPERIORITY_OR_OTHER||compliance rate|0.815|||||ONE_SIDED|95.0|0.792||||Binomial Exact Test|||9-month compliance rate|||0.792|
71832806|NCT00402246|143169754|SUPERIORITY_OR_OTHER||compliance rate|0.814|||||ONE_SIDED|95.0|0.79||||Binomial Exact Test|||12-month compliance rate|||0.79|
71832807|NCT00402246|143169756|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.217
71832808|NCT00402246|143169757|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||The a priori threshold for statistical significance for was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.||||0.154
71832809|NCT02374463|143169818|SUPERIORITY||||||<|0.05||||||P value not adjusted for multiple comparisons|t-test, 2 sided|||within group change was assessed||||<0.05
71889950|NCT03575104|143301809|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.74||||0.3669|TWO_SIDED|95.0|-8.693|3.215||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00977; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.215|-8.693|0.3669
71736303|NCT00655629|142986896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.418|||<|0.0001||95.0|-24.439|-12.396|||ANCOVA|||Statistical analysis applies to the total population.||-12.396|-24.439|<0.0001
71736304|NCT00655629|142986897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.379|||<|0.0001||95.0|-28.006|-16.753|||ANCOVA|||Statistical analysis applies to the total population.||-16.753|-28.006|<0.0001
71736305|NCT00655629|142986898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.758|||<|0.0001||95.0|-36.736|-24.779|||ANOVA|||Statistical analysis applies to the total population.||-24.779|-36.736|<0.0001
71736306|NCT00655629|142986899|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|60.2391|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.||||<0.0001
71736307|NCT00820222|142986923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.36|TWO_SIDED|95.0|0.26|1.63|||Odds Ratio||The Odds Ratio is based on a logistic regression model. The P-value for the test of Odds Ratio is 1.|||1.63|0.26|0.360
71832810|NCT02374463|143169819|SUPERIORITY||||||=|0.08||||||p value not adjusted for multiple comparisons|ANOVA|||||||=0.08
71832811|NCT02374463|143169820|SUPERIORITY||||||=|0.6|||||||ANOVA|not adjusted for multiple comparisons||||||=0.6
71832812|NCT02374463|143169821|SUPERIORITY|||||||0.84||||||Not adjusted for multiple comparisons|Chi-squared|exploratory aim prespecified.||||||0.84
71832813|NCT02374463|143169821|SUPERIORITY||||||=|0.4|||||||Chi-squared|||||||=0.4
71832814|NCT02374463|143169822|SUPERIORITY||||||=|0.3||||||not adjusted for multiple comparisons|ANOVA|||||||=0.3
71832815|NCT02374463|143169823|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71832816|NCT01808339|143169833|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.077|||||TWO_SIDED|90.0|0.001|0.152|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and Placebo (FF 100 µg AM minus Placebo).|||0.152|0.001|
71832817|NCT01808339|143169833|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.105|||||TWO_SIDED|90.0|0.029|0.18|||||The estimated value represents the difference in Least Squares Means between FF 100 µg PM and Placebo (FF 100 µg PM minus Placebo).|||0.180|0.029|
71774048|NCT00736879|143048170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|Tested at alpha=0.019 applying Dunnett's adjustment.||||-0.50|-1.17|<0.0001
71774049|NCT00736879|143048171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5481||0.0018|TWO_SIDED|95.0|-2.81|-0.65||Test was performed at alpha=0.05.|ANCOVA|||By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.||-0.65|-2.81|0.0018
71832818|NCT01808339|143169833|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.028|||||TWO_SIDED|90.0|-0.102|0.045|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and FF 100 µg PM (FF 100 µg AM minus FF 100 µg PM).|||0.045|-0.102|
71736308|NCT00820222|142986924|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.64|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.64|1.04|0.021
71736309|NCT00820222|142986926|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.095|TWO_SIDED|95.0|0.95|1.9|||Log Rank||A HR \> 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.|||1.90|0.95|0.095
71736310|NCT00820222|142986927|SUPERIORITY||Odds Ratio (OR)|0.7984||||0.2731|TWO_SIDED|95.0|0.5407|1.1771|||Fisher Exact|||Comparison for Overall Response (CR+PR)||1.1771|0.5407|0.2731
71736311|NCT00820222|142986928|SUPERIORITY||Odds Ratio (OR)|0.9016||||0.6106|TWO_SIDED|95.0|0.6315|1.2866|||Fisher Exact|||Comparison for Clinical Benefit||1.2866|0.6315|0.6106
71736312|NCT00418574|142986936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099||||0.301|TWO_SIDED|95.0|0.919|1.315|||Regression, Cox|||||1.315|0.919|0.301
71736313|NCT04836247|142986941|SUPERIORITY||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
71736314|NCT04836247|142986942|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
71774050|NCT00736879|143048171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.5474||0.0024|TWO_SIDED|95.0|-2.76|-0.6||Test was performed at alpha=0.05.|ANCOVA|||||-0.60|-2.76|0.0024
71774051|NCT00736879|143048171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.5598||0.0022|TWO_SIDED|95.0|-2.83|-0.63||Test was performed at alpha=0.05.|ANCOVA|||||-0.63|-2.83|0.0022
71889951|NCT03575104|143301810|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-10.25||||0.0028|TWO_SIDED|95.0|-16.95|-3.548||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.01563; statistically significant = YES||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).||-3.548|-16.95|0.0028
71736315|NCT04836247|142986943|SUPERIORITY||Mean Difference (Final Values)|2.61|||<|0.001|TWO_SIDED|||||\<.001 is calculated p-value in SPSS.|t-test, 2 sided|||||||<.001
71736316|NCT04836247|142986944|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
71736317|NCT04836247|142986945|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
71736318|NCT04836247|142986946|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
71736319|NCT02726022|142986979|SUPERIORITY_OR_OTHER|||||||0.647|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.647
71832819|NCT01643616|143169849|SUPERIORITY_OR_OTHER||Percentage Difference|33.0|||<|0.05|||||||Fisher Exact||For success rate without supplementation the difference between group US (94.9%) and group NS (61.9%) is 33%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||< 0.05
71832820|NCT01643616|143169850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.9|||<|0.05|TWO_SIDED|95.0|13.6|31.1|||Log Rank|||We used the log-rank test to compare the onset times. The significance level was defined with p\<0.05.||31.1|13.6|< 0.05
71736320|NCT02726022|142986979|SUPERIORITY_OR_OTHER|||||||0.373|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.373
71736321|NCT02726022|142986980|SUPERIORITY_OR_OTHER|||||||0.049|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.049
71736322|NCT02726022|142986980|SUPERIORITY_OR_OTHER|||||||0.86|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.860
71736323|NCT02726022|142986981|SUPERIORITY_OR_OTHER|||||||0.921|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.921
71736324|NCT02726022|142986981|SUPERIORITY_OR_OTHER|||||||0.962|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.962
71736325|NCT02726022|142986982|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.052
71774052|NCT00736879|143048172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|STANDARD_ERROR_OF_MEAN|5.859||0.0103|TWO_SIDED|95.0|-26.7|-3.6||Test was performed at alpha=0.05.|ANCOVA|||||-3.6|-26.7|0.0103
71774053|NCT00736879|143048172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.816|<|0.0001|TWO_SIDED|95.0|-37.2|-14.3||Test was performed at alpha=0.05.|ANCOVA|||||-14.3|-37.2|<0.0001
71736326|NCT02726022|142986982|SUPERIORITY_OR_OTHER|||||||0.677|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.677
71736327|NCT02726022|142986983|SUPERIORITY_OR_OTHER|||||||0.72|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.720
71736328|NCT02726022|142986983|SUPERIORITY_OR_OTHER|||||||0.237|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.237
71736329|NCT02726022|142986984|SUPERIORITY_OR_OTHER|||||||0.184|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher's exact test.||||0.184
71736330|NCT02726022|142986984|SUPERIORITY_OR_OTHER|||||||0.889|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher's exact test.||||0.889
71736331|NCT03262441|142986992|OTHER||Slope|-0.00033|||||TWO_SIDED|95.0|-0.002|0.0014||||||||0.0014|-0.0020|
71774054|NCT00736879|143048172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.6|STANDARD_ERROR_OF_MEAN|5.962|<|0.0001|TWO_SIDED|95.0|-44.3|-20.8||Test was performed at alpha=0.05.|ANCOVA|||||-20.8|-44.3|<0.0001
71774055|NCT00736879|143048173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.1|STANDARD_ERROR_OF_MEAN|8.8681|<|0.0001|TWO_SIDED|95.0|-59.56|-24.61||Test was performed at alpha=0.05.|ANCOVA|||||-24.61|-59.56|<0.0001
71774056|NCT00736879|143048173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|9.1963|<|0.0001|TWO_SIDED|95.0|-66.27|-30.03||Test was performed at alpha=0.05.|ANCOVA|||||-30.03|-66.27|<0.0001
71774057|NCT00736879|143048173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.6|STANDARD_ERROR_OF_MEAN|9.1796|<|0.0001|TWO_SIDED|95.0|-78.67|-42.5||Test was performed at alpha=0.05.|ANCOVA|||||-42.50|-78.67|<0.0001
71774058|NCT00736879|143048174|SUPERIORITY_OR_OTHER||percent difference|18.9|STANDARD_ERROR_OF_MEAN|7.38||0.0157|TWO_SIDED|95.0|3.6|34.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||34.3|3.6|0.0157
71774059|NCT00736879|143048174|SUPERIORITY_OR_OTHER||Percent Difference|8.8|STANDARD_ERROR_OF_MEAN|7.65||0.2512|TWO_SIDED|95.0|-6.2|23.8||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.8|-6.2|0.2512
71774060|NCT00736879|143048174|SUPERIORITY_OR_OTHER||Percent Difference|14.5|STANDARD_ERROR_OF_MEAN|8.069||0.0726|TWO_SIDED|95.0|-1.3|30.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||30.3|-1.3|0.0726
71774061|NCT00736879|143048175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.7954||0.3163|TWO_SIDED|95.0|-2.37|0.77||Test was performed at alpha=0.05.|ANCOVA|||||0.77|-2.37|0.3163
71736332|NCT03262441|142986993|OTHER||Slope|0.001|||||TWO_SIDED|95.0|-0.0036|0.0056||||||||0.0056|-0.0036|
71736333|NCT03262441|142986994|OTHER||Slope|0.0024|||||TWO_SIDED|95.0|-0.003|0.0078||||||||0.0078|-0.003|
71736334|NCT00559988|142987006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.064||||0.732|TWO_SIDED|95.0|0.75|1.51|||Regression, Cox|||||1.51|0.75|0.732
71736335|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|105.2|||||TWO_SIDED|90.0|90.61|122.13||||||AUCtau of GS-331007 for the 12 to \< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||122.13|90.61|
71736336|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|65.76|||||TWO_SIDED|90.0|56.62|76.37||||||AUCtau of GS-331007 for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||76.37|56.62|
71736337|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|94.08|||||TWO_SIDED|90.0|82.51|107.27||||||AUCtau of GS-331007 for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||107.27|82.51|
71736338|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|127.18|||||TWO_SIDED|90.0|94.89|170.45||||||AUCtau of LDV for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||170.45|94.89|
71736339|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|82.25|||||TWO_SIDED|90.0|61.34|110.3||||||AUCtau of LDV for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||110.30|61.34|
71736340|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|120.46|||||TWO_SIDED|90.0|93.18|155.73||||||AUCtau of LDV for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||155.73|93.18|
71660255|NCT04188301|142834849|SUPERIORITY||Odds Ratio (OR)|1.03||||0.918|TWO_SIDED|95.0|0.59|1.79||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA vs IDA3 for living female O. volvulus worms in nodules after treatment.||1.79|0.59|0.918
71660256|NCT04188301|142834852|SUPERIORITY||Odds Ratio (OR)|1.66||||0.134|TWO_SIDED|95.0|0.85|3.21||Adjusted p values were model-adjusted for repeated measurements per person. Participant level random effects were included in the model to adjust for multiple worms/person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA in fertile female O. volvulus worms in nodules after treatment.||3.21|0.85|0.134
71736341|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|159.88|||||TWO_SIDED|90.0|137.89|185.37||||||AUCtau of SOF for the 12 to \< 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||185.37|137.89|
71736342|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||TWO_SIDED|90.0|110.79|151.32||||||AUCtau of SOF for the 6 to \< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||151.32|110.79|
71736343|NCT02249182|142987015|EQUIVALENCE|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|187.76|||||TWO_SIDED|90.0|143.41|245.82||||||AUCtau of SOF for the 3 to \< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.||245.82|143.41|
71736344|NCT01455194|142987036|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.122|STANDARD_ERROR_OF_MEAN|0.1175||0.2988|TWO_SIDED|95.0|-0.353|0.109|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.109|-0.353|0.2988
71736345|NCT01455194|142987036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.118||0.7741|TWO_SIDED|95.0|-0.198|0.266|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.266|-0.198|0.7741
71736346|NCT01455194|142987036|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.1172||0.1835|TWO_SIDED|95.0|-0.387|0.074|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.||0.074|-0.387|0.1835
71736347|NCT01455194|142987038|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|0.0||||0.8465|TWO_SIDED|95.0|-3.0|4.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||4.000|-3.000|0.8465
71736348|NCT01455194|142987038|SUPERIORITY_OR_OTHER||Hodges-Lehmann point estimate|1.0||||0.4175|TWO_SIDED|95.0|-2.0|5.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.|||5.000|-2.000|0.4175
71736349|NCT01455194|142987039|SUPERIORITY_OR_OTHER|||||||0.4186|||||||Fisher Exact|||Well-controlled Asthma||||0.4186
71736350|NCT01455194|142987039|SUPERIORITY_OR_OTHER|||||||0.146|||||||Fisher Exact|||Well-controlled Asthma||||0.1460
71736351|NCT01455194|142987039|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Fisher Exact|||Well-controlled Asthma||||0.6017
71774062|NCT00736879|143048175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.8154|||TWO_SIDED|95.0|-2.22|0.99|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.99|-2.22|
71774063|NCT00736879|143048175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|0.8238|||TWO_SIDED|95.0|-3.09|0.16|||ANCOVA|||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.||0.16|-3.09|
71774064|NCT02398409|143048211|SUPERIORITY||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.117||0.8407|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||12 weeks compared to Baseline (BL)||||.8407
71736352|NCT01455194|142987039|SUPERIORITY_OR_OTHER|||||||0.3305|||||||Fisher Exact|||ACQ Improvement||||0.3305
71736353|NCT01455194|142987039|SUPERIORITY_OR_OTHER|||||||0.486|||||||Fisher Exact|||ACQ Improvement||||0.4860
71736354|NCT01455194|142987039|SUPERIORITY_OR_OTHER|||||||0.8922|||||||Fisher Exact|||ACQ Improvement||||0.8922
71736355|NCT01455194|142987040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.042|STANDARD_ERROR_OF_MEAN|0.0806||0.6062|TWO_SIDED|95.0|0.89|1.221|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.221|0.890|0.6062
71736356|NCT01455194|142987040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0669||0.4674|TWO_SIDED|95.0|0.921|1.197|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.197|0.921|0.4674
71736357|NCT01455194|142987040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.201|STANDARD_ERROR_OF_MEAN|0.1597||0.2523|TWO_SIDED|95.0|0.878|1.642|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.642|0.878|0.2523
71736358|NCT01455194|142987040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913|STANDARD_ERROR_OF_MEAN|0.1354||0.5026|TWO_SIDED|95.0|0.7|1.191|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.191|0.700|0.5026
71736359|NCT01455194|142987040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898|STANDARD_ERROR_OF_MEAN|0.156||0.4893|TWO_SIDED|95.0|0.661|1.219|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|Well-controlled Asthma||1.219|0.661|0.4893
71774065|NCT02398409|143048211|SUPERIORITY||Median Difference (Net)|0.201|STANDARD_ERROR_OF_MEAN|0.12||0.015|TWO_SIDED|||||Adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression.|Mixed Models Analysis|||At 6 months compared to BL||||.0150
71774066|NCT02398409|143048211|SUPERIORITY||Median Difference (Net)|0.114|STANDARD_ERROR_OF_MEAN|0.188||0.8373|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared BL||||.8373
71736360|NCT01455194|142987040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.181|STANDARD_ERROR_OF_MEAN|0.1351||0.2193|TWO_SIDED|95.0|0.906|1.538|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ Improvement||1.538|0.906|0.2193
71736361|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.058|STANDARD_ERROR_OF_MEAN|0.0917||0.5397|TWO_SIDED|95.0|0.884|1.266|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.266|0.884|0.5397
71736362|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005|STANDARD_ERROR_OF_MEAN|0.0738||0.9458|TWO_SIDED|95.0|0.87|1.161|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.161|0.870|0.9458
71736363|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026|STANDARD_ERROR_OF_MEAN|0.0708||0.7213|TWO_SIDED|95.0|0.893|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.178|0.893|0.7213
71736364|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.0692||0.4807|TWO_SIDED|95.0|0.917|1.202|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.202|0.917|0.4807
71736365|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326|STANDARD_ERROR_OF_MEAN|0.1791||0.115|TWO_SIDED|95.0|0.934|1.884|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.884|0.934|0.1150
71736366|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.074|STANDARD_ERROR_OF_MEAN|0.1467||0.6281|TWO_SIDED|95.0|0.805|1.431|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.431|0.805|0.6281
71736367|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.059|STANDARD_ERROR_OF_MEAN|0.1415||0.6853|TWO_SIDED|95.0|0.803|1.397|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.397|0.803|0.6853
71736368|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055|STANDARD_ERROR_OF_MEAN|0.1388||0.6995|TWO_SIDED|95.0|0.804|1.385|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.385|0.804|0.6995
71736369|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.837|STANDARD_ERROR_OF_MEAN|0.1744||0.308|TWO_SIDED|95.0|0.595|1.178|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 0.5||1.178|0.595|0.3080
71736370|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939|STANDARD_ERROR_OF_MEAN|0.1461||0.6645|TWO_SIDED|95.0|0.705|1.25|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.0||1.250|0.705|0.6645
71736371|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992|STANDARD_ERROR_OF_MEAN|0.1408||0.9564|TWO_SIDED|95.0|0.753|1.308|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.25||1.308|0.753|0.9564
71736372|NCT01455194|142987041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047|STANDARD_ERROR_OF_MEAN|0.1375||0.7367|TWO_SIDED|95.0|0.8|1.371|||Log Rank||A hazard ratio of \>1 represented a benefit for the test treatment.|ACQ cut-off at 1.5||1.371|0.800|0.7367
71736373|NCT01455194|142987042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.367|STANDARD_ERROR_OF_MEAN|0.2583||0.2264|TWO_SIDED|95.0|0.824|2.267|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.267|0.824|0.2264
71736374|NCT01455194|142987042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.102|STANDARD_ERROR_OF_MEAN|0.5001||0.1373|TWO_SIDED|95.0|0.789|5.602|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||5.602|0.789|0.1373
71736375|NCT01455194|142987042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882|STANDARD_ERROR_OF_MEAN|0.4365||0.7732|TWO_SIDED|95.0|0.375|2.074|||Log Rank||A hazard ratio of \<1 represented a benefit for the test treatment.|||2.074|0.375|0.7732
71736376|NCT01455194|142987043|SUPERIORITY_OR_OTHER|||||||0.288|||||||Fisher Exact|||||||0.2880
71736377|NCT01455194|142987043|SUPERIORITY_OR_OTHER|||||||0.2864|||||||Fisher Exact|||||||0.2864
71736378|NCT01092663|142987067|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736379|NCT01092663|142987068|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736380|NCT01092663|142987069|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effects between the 2 groups||||>0.05
71736381|NCT01092663|142987070|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736382|NCT01092663|142987071|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736383|NCT01092663|142987072|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
71736384|NCT01092663|142987073|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Treament difference in fasting EGP between the 2 groups were compared.||||>0.05
71736385|NCT01092663|142987074|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between groups was evaluated||||>0.05
71736386|NCT01092663|142987075|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired ttest||Difference in treatment effect between groups was evaluated||||>0.05
71736387|NCT01092663|142987076|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736388|NCT01092663|142987077|SUPERIORITY_OR_OTHER||||||=|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||=0.01
71736389|NCT01092663|142987078|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||differerences in treatment effect between the 2 groups||||>0.05
71736390|NCT01092663|142987079|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71774067|NCT02398409|143048212|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.173||0.6445|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.6445
71774068|NCT02398409|143048212|SUPERIORITY||Median Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.158||0.5247|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.5247
71832821|NCT01643616|143169851|SUPERIORITY_OR_OTHER||Percentage Difference|26.2||||0.05|||||||Fisher Exact||For success rate with supplementation the difference between group US (98.2%) and group NS (72%) is 26.2%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.||||0.05
71832822|NCT02622568|143169852|NON_INFERIORITY|Veregen alone has efficacy compared to Veregen + cryotherapy|Mean Difference (Final Values)|1.556||||0.383|TWO_SIDED|||||Comparison at week 12|t-test, 2 sided|||||||0.383
71832823|NCT02622568|143169852|NON_INFERIORITY|Comparison at week 0|Mean Difference (Final Values)|-0.222||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
71736391|NCT01092663|142987080|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736392|NCT01092663|142987081|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71832824|NCT04425863|143169866|OTHER|||||||0.0246|||||||Chi-squared|||A chi-squared test is used to find out whether there is a statistically significant decrease in mortality rate when the IDEA treatment protocol is used in hospitalized patients in comparison with other treatments in the same hospital in the same period of time (3 out of 12 inpatients died)||||0.0246
71832825|NCT04425863|143169866|OTHER|||||||0.0475|||||||Chi-squared|||Overall mortality rate of patients treated according to IDEA protocol is compared by a chi-squared test against overall mortality rate in Argentina (the same region where the hospital is located). Data used for overall mortality in Argentina correspond to June 30th according to the website of the Ministry of Health of Argentina||||0.0475
71736393|NCT01092663|142987082|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736394|NCT01092663|142987083|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
71736395|NCT01092663|142987084|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.05
71736396|NCT01092663|142987085|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
71736397|NCT01092663|142987086|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||<0.01
71736398|NCT01092663|142987087|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups||||>0.05
71736399|NCT00781859|142987262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56||||0.003|TWO_SIDED|95.0|1.32|5.24||comparing placebo and ocriplasmin|Fisher Exact|||||5.24|1.32|0.003
71736400|NCT05546229|142987266|OTHER|||||||0.0049|||||||t-test, 2 sided|8 degrees of freedom||patient plasma versus isf value for methadone||||.0049
71736401|NCT05546229|142987267|OTHER|||||||0.0025|||||||t-test, 2 sided|8 degrees of freedom||||||.0025
71736402|NCT01220180|142987286|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736403|NCT01220180|142987287|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736404|NCT01220180|142987288|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736405|NCT01220180|142987289|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736406|NCT01220180|142987290|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736407|NCT01220180|142987291|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736408|NCT01220180|142987292|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71736409|NCT01220180|142987293|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71774069|NCT02398409|143048212|SUPERIORITY||Median Difference (Net)|0.1224|STANDARD_ERROR_OF_MEAN|0.187||0.9974|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.9974
71774070|NCT02398409|143048213|SUPERIORITY||Median Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.087||0.1918|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||12 weeks compared to BL||||.1918
71774071|NCT02398409|143048213|SUPERIORITY||Median Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.078||0.9212|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||6 months compared to BL||||.9212
71774072|NCT02398409|143048213|SUPERIORITY||Median Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.083||0.2358|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.2358
71774073|NCT02398409|143048214|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|0.168||0.1107|TWO_SIDED||||||Mixed Models Analysis|||12 weeks compared to BL||||.1107
71774074|NCT02398409|143048214|SUPERIORITY|adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Median Difference (Net)|0.251|STANDARD_ERROR_OF_MEAN|0.211||0.0562|TWO_SIDED||||||Mixed Models Analysis|||6 months compared to BL||||.0562
71832826|NCT04425863|143169866|OTHER|||||||0.0025|||||||Chi-squared|||A chi-square test was applied to compare the mortality rate of patients treated with IDEA protocol as compared with data published (26.84 %) in Bertsimas D, Lukin G, Mingardi L, Nohadani O, Orfanoudaki A, Stellato B et al. (2020), COVID-19 Mortality Risk Assessment: An International Multi-Center Study doi: 10.1101/2020.07.07.20148304||||0.0025
71832827|NCT01854385|143169872|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||.079
71660257|NCT04188301|142834852|SUPERIORITY||Odds Ratio (OR)|2.23||||0.023|TWO_SIDED|95.0|1.12|4.44||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||4.44|1.12|0.023
71660258|NCT04188301|142834852|SUPERIORITY||Odds Ratio (OR)|1.32||||0.43|TWO_SIDED|95.0|0.64|2.85||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IDA1 vs IDA3 for fertile female O. volvulus worms in nodules after treatment.||2.85|.64|0.430
71660259|NCT04188301|142834852|SUPERIORITY||Odds Ratio (OR)|1.91||||0.023|TWO_SIDED|95.0|1.09|3.34||Participant level random effects were included in the model to adjust for multiple worms/person. Adjusted P values were model-adjusted for repeated measurements per person.|Regression, Logistic|Mixed-effects logistic regression model where study participant was included as a random effect to adjust for multiple worms per person.||IA vs IDA treatment groups for fertile female O. volvulus worms in nodules after treatment.||3.34|1.09|0.023
71736410|NCT02713659|142987308|EQUIVALENCE|0.05||||||0.85|||||||t-test, 2 sided|||Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.85
71736411|NCT02713659|142987308|EQUIVALENCE|0.05||||||0.53|||||||t-test, 2 sided|||Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.53
71736412|NCT02713659|142987308|EQUIVALENCE|0.05||||||0.49|||||||t-test, 2 sided|||Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm||||0.49
71736413|NCT02713659|142987309|EQUIVALENCE|0.05||||||0.57|||||||t-test, 2 sided|||Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy arm||||0.57
71736414|NCT02713659|142987310|EQUIVALENCE|0.05||||||0.23|||||||Chi-squared|||Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of age||||0.23
71736415|NCT02713659|142987310|EQUIVALENCE|0.05||||||0.71|||||||Chi-squared|||Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of age||||0.71
71736416|NCT04943432|142987318|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||T2 - T1||||0.06
71736417|NCT04943432|142987318|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||T3 - T1||||0.68
71736418|NCT04943432|142987320|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
71736419|NCT04943432|142987320|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||T3-T1||||.32
71890234|NCT01813890|143302104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|105.61||||0.006|TWO_SIDED|95.0|32.0|179.2||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||179.2|32.0|0.006
71736420|NCT04943432|142987321|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||T2-T1||||.44
71736421|NCT04943432|142987321|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||T3-T1||||.007
71736422|NCT04943432|142987325|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||T2-T1||||.01
71660260|NCT00786994|142834864|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Mantel Haenszel|||A vs C/D||||0.60
71660261|NCT00786994|142834864|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Mantel Haenszel|||B vs. C/D||||0.83
71736423|NCT04943432|142987325|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||T3-T1||||.11
71736424|NCT04943432|142987326|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||T2-T1||||.82
71736425|NCT04943432|142987326|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||T3-T1||||.36
71736426|NCT04943432|142987327|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||T2-T1||||.34
71736427|NCT04943432|142987327|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||T3-T1||||.02
71736428|NCT04943432|142987329|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||T2-T1||||.14
71736429|NCT04943432|142987329|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||T3-T1||||.29
71736430|NCT04943432|142987331|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||T2-T1||||<.001
71736431|NCT04943432|142987331|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||T3-T1||||.23
71736432|NCT01727414|142987359|SUPERIORITY|General linear mixed models were used to evaluate the subtype\*dose interaction to determine if the subtypes have unique MPH dose-response curves, with the outcome being Attention Deficit Hyperactivity Disorder total symptom scores (minimum=0, maximum=54, higher=worse)|Slope|0.29|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71736433|NCT02684188|142987400|SUPERIORITY|||||||0.03||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.030
71736434|NCT02684188|142987400|SUPERIORITY|||||||0.025||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 7 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.025
71736435|NCT02684188|142987400|SUPERIORITY|||||||0.037||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 14 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.037
71774075|NCT02398409|143048214|SUPERIORITY||Median Difference (Net)|0.226|STANDARD_ERROR_OF_MEAN|0.218||0.8579|TWO_SIDED|||||adjusting for the covariates of diagnosis and baseline mean value in caregivers' depression|Mixed Models Analysis|||1 year compared to BL||||.8579
71774076|NCT03963401|143048218|SUPERIORITY||Mean Difference (Final Values)|21.23|STANDARD_ERROR_OF_MEAN|10.51||0.1172|TWO_SIDED|90.0|3.94|38.52|||Normal approximation, Dunnett's method|||||38.52|3.94|0.1172
71774077|NCT03963401|143048218|SUPERIORITY||Median Difference (Final Values)|23.38|STANDARD_ERROR_OF_MEAN|8.58||0.0197|TWO_SIDED|90.0|9.26|37.5|||Normal approximation, Dunnett's Method|||||37.50|9.26|0.0197
71774078|NCT03963401|143048218|SUPERIORITY||Median Difference (Final Values)|31.29|STANDARD_ERROR_OF_MEAN|8.29||0.0006|TWO_SIDED|90.0|17.65|44.93|||Normal approximation, Dunnett's Method|||||44.93|17.65|0.0006
71774079|NCT03963401|143048219|SUPERIORITY||Mean Difference (Final Values)|20.95|STANDARD_ERROR_OF_MEAN|11.09||0.0588|TWO_SIDED|90.0|2.72|39.19|||Normal approximation method|||||39.19|2.72|0.0588
71774080|NCT03963401|143048219|SUPERIORITY||Median Difference (Final Values)|26.31|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|90.0|11.72|40.9|||Normal approximation method|||||40.90|11.72|0.0030
71774081|NCT03963401|143048219|SUPERIORITY||Median Difference (Final Values)|31.21|STANDARD_ERROR_OF_MEAN|8.68||0.0003|TWO_SIDED|90.0|16.93|45.5|||Normal approximation method|||||45.50|16.93|0.0003
71774082|NCT04231318|143048248|SUPERIORITY|||||||0.0406|||||||ANOVA|||||||0.0406
71774083|NCT04231318|143048248|SUPERIORITY|||||||0.0795|||||||ANOVA|||||||0.0795
71736436|NCT02684188|142987400|SUPERIORITY|||||||0.011||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 21 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.011
71736437|NCT02684188|142987400|SUPERIORITY|||||||0.05||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 30 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.050
71736438|NCT02684188|142987400|SUPERIORITY|||||||0.055|||||||Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 60 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.055
71774084|NCT04231318|143048248|SUPERIORITY|||||||0.7601|||||||ANOVA|||||||0.7601
71774085|NCT04231318|143048249|SUPERIORITY|||||||0.1942|||||||ANOVA|||||||0.1942
71736439|NCT02684188|142987400|SUPERIORITY|||||||0.137||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 90 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.137
71736440|NCT02684188|142987401|SUPERIORITY|||||||0.279||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.|||0.279
71774086|NCT04231318|143048249|SUPERIORITY|||||||0.0957|||||||ANOVA|||||||0.0957
71660262|NCT03564444|142834865|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
71774087|NCT04231318|143048249|SUPERIORITY|||||||0.4526|||||||ANOVA|||||||0.4526
71774088|NCT04231318|143048250|SUPERIORITY|||||||0.1309|||||||ANOVA|||||||0.1309
71774089|NCT04231318|143048250|SUPERIORITY|||||||0.17|||||||ANOVA|||||||0.1700
71774090|NCT04231318|143048250|SUPERIORITY|||||||0.7609|||||||ANOVA|||||||0.7609
71774091|NCT04231318|143048251|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.1000
71774092|NCT04231318|143048251|SUPERIORITY|||||||0.0423|||||||ANOVA|||||||0.0423
71774093|NCT04231318|143048251|SUPERIORITY|||||||0.383|||||||ANOVA|||||||0.3830
71774094|NCT04231318|143048252|SUPERIORITY|||||||0.0298|||||||ANOVA|||||||0.0298
71774095|NCT04231318|143048252|SUPERIORITY|||||||0.0217|||||||ANOVA|||||||0.0217
71774096|NCT04231318|143048252|SUPERIORITY|||||||0.4451|||||||ANOVA|||||||0.4451
71774097|NCT04231318|143048253|SUPERIORITY|||||||0.1197|||||||ANOVA|||||||0.1197
71774098|NCT04231318|143048253|SUPERIORITY|||||||0.0008|||||||ANOVA|||||||0.0008
71774099|NCT04231318|143048253|SUPERIORITY|||||||0.0223|||||||ANOVA|||||||0.0223
71774100|NCT04231318|143048254|SUPERIORITY|||||||0.1067|||||||ANOVA|||||||0.1067
71774101|NCT04231318|143048255|SUPERIORITY|||||||0.1715|||||||ANOVA|||||||0.1715
71774102|NCT04231318|143048255|SUPERIORITY|||||||0.0736|||||||ANOVA|||||||0.0736
71774103|NCT04231318|143048255|SUPERIORITY|||||||0.4098|||||||ANOVA|||||||0.4098
71774104|NCT04231318|143048256|SUPERIORITY|||||||0.2718|||||||ANOVA|||||||0.2718
71774105|NCT04231318|143048256|SUPERIORITY|||||||0.0182|||||||ANOVA|||||||0.0182
71774106|NCT04231318|143048256|SUPERIORITY|||||||0.1131|||||||ANOVA|||||||0.1131
71774107|NCT04231318|143048257|SUPERIORITY|||||||0.2143|||||||ANOVA|||||||0.2143
71774108|NCT04231318|143048257|SUPERIORITY|||||||0.1628|||||||ANOVA|||||||0.1628
71774109|NCT04231318|143048257|SUPERIORITY|||||||0.6036|||||||ANOVA|||||||0.6036
71774110|NCT04231318|143048258|SUPERIORITY|||||||0.222|||||||ANOVA|||||||0.2220
71774111|NCT04231318|143048258|SUPERIORITY|||||||0.141|||||||ANOVA|||||||0.1410
71774112|NCT04231318|143048258|SUPERIORITY|||||||0.5418|||||||ANOVA|||||||0.5418
71774113|NCT04231318|143048259|SUPERIORITY|||||||0.1619|||||||ANOVA|||||||0.1619
71774114|NCT04231318|143048259|SUPERIORITY|||||||0.1683|||||||ANOVA|||||||0.1683
71774115|NCT04231318|143048259|SUPERIORITY|||||||0.6969|||||||ANOVA|||||||0.6969
71774116|NCT04231318|143048260|SUPERIORITY|||||||0.0701|||||||ANOVA|||||||0.0701
71774117|NCT04231318|143048260|SUPERIORITY|||||||0.0925|||||||ANOVA|||||||0.0925
71774118|NCT04231318|143048260|SUPERIORITY|||||||0.6981|||||||ANOVA|||||||0.6981
71832828|NCT02597920|143169905|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 2.||||<0.0001
71832829|NCT02597920|143169905|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 3.||||<0.0001
71832830|NCT02597920|143169905|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 2.||||<0.0001
71832831|NCT02597920|143169905|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 3.||||<0.0001
71660263|NCT00006721|142834871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.11|TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||1.05|0.6|0.11
71660264|NCT00006721|142834875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55||||0.08|TWO_SIDED|95.0|0.95|2.54|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab|||2.54|0.95|0.08
71736441|NCT02684188|142987401|SUPERIORITY|||||||0.211||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.|||0.211
71736442|NCT02684188|142987401|SUPERIORITY|||||||0.424||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.|||0.424
71736443|NCT02684188|142987401|SUPERIORITY|||||||0.191||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.|||0.191
71774119|NCT04231318|143048261|SUPERIORITY|||||||0.0275|||||||ANOVA|||||||0.0275
71774120|NCT04231318|143048261|SUPERIORITY|||||||0.1738|||||||ANOVA|||||||0.1738
71736444|NCT02684188|142987401|SUPERIORITY|||||||0.478||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.|||0.478
71736445|NCT02684188|142987401|SUPERIORITY|||||||0.452||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.|||0.452
71736446|NCT02684188|142987401|SUPERIORITY|H0: There is no difference in the proportion of patients with at least one ED visits by day 90 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.||||||0.381||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic||||For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.|||0.381
71736447|NCT02684188|142987402|SUPERIORITY|||||||0.502||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.502
71736448|NCT02684188|142987402|SUPERIORITY|||||||0.286||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 7 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.286
71774121|NCT04231318|143048261|SUPERIORITY|||||||0.8364|||||||ANOVA|||||||0.8364
71774122|NCT04231318|143048262|SUPERIORITY|||||||0.2227|||||||ANOVA|||||||0.2227
71774123|NCT04231318|143048262|SUPERIORITY|||||||0.1114|||||||ANOVA|||||||0.1114
71774124|NCT04231318|143048262|SUPERIORITY|||||||0.4635|||||||ANOVA|||||||0.4635
71774125|NCT02961218|143048263|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.57||0.55|TWO_SIDED|90.0|-1.03|0.85||probability reduction of average pain score in ACZ885 \> Placebo|Bayesian model for repeated measures||Lower limit and upper limit represents the credibility interval from the Bayesian analysis.|||0.85|-1.03|0.55
71774126|NCT02961218|143048265|SUPERIORITY||Ratio|0.408||||0.002|TWO_SIDED|90.0|0.253|0.658|||Mixed-effect Model for Repeated Measures|||||0.658|0.253|0.002
71774127|NCT02961218|143048266|SUPERIORITY||Ratio|0.752|||<|0.001|TWO_SIDED|90.0|0.657|0.862|||Mixed-effect Model for Repeated Measures|||||0.862|0.657|<.001
71832832|NCT02597920|143169906|OTHER|||||||0.0005|||||||Propensity score matching method|||Between group comparison of Visit 2 CDS||||0.0005
71832833|NCT02597920|143169906|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 3 CDS||||0.0002
71832834|NCT02597920|143169906|OTHER|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 2 SDS||||0.0002
71832835|NCT02597920|143169906|OTHER|||||||0.0004|||||||Propensity score matching method|||Between group comparison of Visit 3 SDS||||0.0004
71832836|NCT02597920|143169911|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 CDS with that of Visit 3.||||<0.0001
71832837|NCT02597920|143169911|OTHER||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 SDS with that of Visit 3.||||<0.0001
71832838|NCT04040296|143169920|SUPERIORITY||Difference in percentage|1.4||||0.28|TWO_SIDED|95.0|-1.1|3.8|||Cochran-Mantel-Haenszel||Difference between arms in the percentage of subjects with the primary outcome within 14 days of randomization.|||3.8|-1.1|0.28
71660265|NCT06378749|142834877|OTHER|||||||0.029|||||||t-test, 2 sided|||||||.029
71660266|NCT06378749|142834878|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71660267|NCT06378749|142834879|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71660268|NCT06378749|142834880|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71660269|NCT06378749|142834881|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71736449|NCT02684188|142987402|SUPERIORITY|||||||0.347||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 14 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.347
71736450|NCT02684188|142987402|SUPERIORITY|||||||0.25||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 21 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.250
71736451|NCT02684188|142987402|SUPERIORITY|||||||0.22||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 30 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.220
71736452|NCT02684188|142987402|SUPERIORITY|||||||0.116||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 60 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.116
71736453|NCT02684188|142987402|SUPERIORITY|||||||0.126||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 90 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.126
71736454|NCT02684188|142987403|SUPERIORITY|||||||0.597||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.|||0.597
71736455|NCT02684188|142987403|SUPERIORITY|||||||0.504||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.|||0.504
71736456|NCT02684188|142987403|SUPERIORITY|||||||0.558||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.|||0.558
71736457|NCT02684188|142987403|SUPERIORITY|||||||0.472||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.|||0.472
71736458|NCT02684188|142987403|SUPERIORITY|||||||0.462||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.462
71774128|NCT02961218|143048267|SUPERIORITY||Ratio|0.682||||0.004|TWO_SIDED|90.0|0.547|0.849|||Mixed-effect Model for Repeated Measures|||||0.849|0.547|0.004
71774129|NCT02961218|143048268|SUPERIORITY||Ratio|0.718||||0.032|TWO_SIDED|90.0|0.556|0.925|||Mixed-effect Model for Repeated Measures|||||0.925|0.556|0.032
71774130|NCT02961218|143048275|SUPERIORITY||Ratio|1.4|STANDARD_ERROR_OF_MEAN|0.45||0.455|TWO_SIDED|90.0|0.58|3.4|||Generalized Linear Model (GLM)|||||3.40|0.58|0.455
71774131|NCT00591266|143048278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.19|||<|0.001|TWO_SIDED|95.0|-13.29|-9.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.09|-13.29|<0.001
71774132|NCT00591266|143048278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91|||<|0.001|TWO_SIDED|95.0|-13.0|-8.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.81|-13.00|<0.001
71774133|NCT00591266|143048279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-13.93|-8.1||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-8.10|-13.93|<0.001
71774134|NCT00591266|143048279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.56|||<|0.001|TWO_SIDED|95.0|-12.48|-6.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-6.63|-12.48|<0.001
71660270|NCT05538065|142834882|SUPERIORITY||Risk Ratio (RR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.78||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.78|1.10|0.002
71774135|NCT00591266|143048280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.48|||<|0.001|TWO_SIDED|95.0|-8.84|-6.11||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.11|-8.84|<0.001
71774136|NCT00591266|143048280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.65|||<|0.001|TWO_SIDED|95.0|-9.01|-6.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-9.01|<0.001
71774137|NCT00591266|143048281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.93|||<|0.001|TWO_SIDED|95.0|-6.62|-3.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.23|-6.62|<0.001
71774138|NCT00591266|143048281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.58|||<|0.001|TWO_SIDED|95.0|-7.28|-3.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.88|-7.28|<0.001
71774139|NCT00591266|143048282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.64|||<|0.001|TWO_SIDED|95.0|-13.86|-9.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.41|-13.86|<0.001
71774140|NCT00591266|143048282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.17|||<|0.001|TWO_SIDED|95.0|-13.39|-8.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.95|-13.39|<0.001
71774141|NCT00591266|143048283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-9.47|-6.5||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.50|-9.47|<0.001
71774142|NCT00591266|143048283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.04|||<|0.001|TWO_SIDED|95.0|-9.52|-6.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.55|-9.52|<0.001
71774143|NCT00591266|143048284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.001|TWO_SIDED|95.0|-12.07|-7.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.34|-12.07|<0.001
71774144|NCT00591266|143048284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|||<|0.001|TWO_SIDED|95.0|-12.03|-7.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.31|-12.03|<0.001
71774145|NCT00591266|143048285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26|||<|0.001|TWO_SIDED|95.0|-7.94|-4.57||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.57|-7.94|<0.001
71774146|NCT00591266|143048285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28|||<|0.001|TWO_SIDED|95.0|-7.96|-4.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.60|-7.96|<0.001
71774147|NCT00591266|143048286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.27|||<|0.001|TWO_SIDED|95.0|-14.63|-9.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.92|-14.63|<0.001
71774148|NCT00591266|143048286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||<|0.001|TWO_SIDED|95.0|-13.93|-9.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.23|-13.93|<0.001
71774149|NCT00591266|143048287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.39|||<|0.001|TWO_SIDED|95.0|-9.98|-6.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-9.98|<0.001
71774150|NCT00591266|143048287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.23|||<|0.001|TWO_SIDED|95.0|-9.82|-6.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-9.82|<0.001
71774151|NCT00591266|143048288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83|||<|0.001|TWO_SIDED|95.0|-11.45|-6.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-11.45|<0.001
71774152|NCT00591266|143048288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.001|TWO_SIDED|95.0|-11.51|-6.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.30|-11.51|<0.001
71774153|NCT00591266|143048289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|||<|0.001|TWO_SIDED|95.0|-7.88|-4.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.00|-7.88|<0.001
71774154|NCT00591266|143048289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-8.47|-4.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.61|-8.47|<0.001
71774155|NCT00591266|143048290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.15|5.26||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.26|2.15|<0.001
71774156|NCT00591266|143048290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.05|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|2.05|<0.001
71889952|NCT03575104|143301810|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS Mean difference to placebo|-1.95||||0.5686|TWO_SIDED|95.0|-8.666|4.764||Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 10 mg vs placebo).||4.764|-8.666|0.5686
71736459|NCT02684188|142987403|SUPERIORITY|||||||0.394||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.|||0.394
71774157|NCT00591266|143048291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.54|||<|0.001|TWO_SIDED|95.0|2.08|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.08|<0.001
71774158|NCT00591266|143048291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.25|6.75||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.75|2.25|<0.001
71774159|NCT00591266|143048292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.71|4.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.02|1.71|<0.001
71774160|NCT00591266|143048292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.12|||<|0.001|TWO_SIDED|95.0|2.01|4.82||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.82|2.01|<0.001
71774161|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.25||||0.5196|TWO_SIDED|95.0|-1.02|0.52||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.25 hours||0.52|-1.02|0.5196
71774162|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.32||||0.3983|TWO_SIDED|95.0|-1.09|0.44||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change in VAS score from baseline at 0.5 hours||0.44|-1.09|0.3983
71774163|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.26||||0.489|TWO_SIDED|95.0|-1.03|0.5||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 0.75 hours||0.5|-1.03|0.4890
71774164|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.21||||0.5903|TWO_SIDED|95.0|-0.97|0.56||No adjustment for multiple comparisons was made due to the exploratory nature of the study|Mixed Models Analysis||Difference is LAT8881 minus placebo|Change from baseline VAS score at 1 hour||0.56|-0.97|0.5903
71774165|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.13||||0.7352|TWO_SIDED|95.0|-0.9|0.64||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 1.5 hours||0.64|-0.90|0.7352
71774166|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2 hours||0.61|-0.92|0.6892
71736460|NCT02684188|142987403|SUPERIORITY|||||||0.368||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 90; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.|||0.368
71832839|NCT04040296|143169921|SUPERIORITY||Difference in percentage|9.5|||<|0.001|TWO_SIDED|95.0|8.1|11.0|||Van Elteren test||Difference between arms in the percentage of implemented recommendations with 24 hours of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||11|8.1|<.001
71736461|NCT02684188|142987404|SUPERIORITY|||||||0.946||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||The following hypotheses were tested: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.946
71736462|NCT02684188|142987404|SUPERIORITY|||||||0.613|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.613
71736463|NCT02684188|142987404|SUPERIORITY|||||||0.541||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.541
71736464|NCT02684188|142987404|SUPERIORITY|||||||0.765||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|For day 21, 98 (58 baseline and 40 intervention) patients were used in this analysis.|||0.765
71832840|NCT04040296|143169922|SUPERIORITY||Difference in percentage|0.5||||0.65|TWO_SIDED|95.0|-1.6|2.6|||Van Elteren test||Difference between arms in the percentage of subjects with AKI progression within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.6|-1.6|.65
71832841|NCT04040296|143169923|SUPERIORITY||Difference in percentage|0.1||||0.89|TWO_SIDED|95.0|-0.7|0.8|||Van Elteren test||Difference between arms in the percentage of subjects who received inpatient dialysis within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.8|-.7|.89
71736465|NCT02684188|142987404|SUPERIORITY|||||||0.919||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.919
71736466|NCT02684188|142987404|SUPERIORITY|||||||0.999||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.999
71736467|NCT02684188|142987404|SUPERIORITY|||||||0.995|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.995
71736468|NCT02684188|142987405|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF12 Physical Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, and the number of people in a household. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.371||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.371, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF12 Physical Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF12 Physical Health scores differ between the standard and enhanced discharge groups.||||0.371
71736469|NCT02684188|142987406|EQUIVALENCE|A repeated measures ANOVA model was used to model the SF-12 Mental Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and county. All hypotheses were 2-sided and p-values \< 0.05 were considered statistically significant.||||||0.232||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.232, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF-12 Mental Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF-12 Mental Health scores differ between the standard and enhanced discharge groups.||||0.232
71832842|NCT04040296|143169924|SUPERIORITY||Difference in percentage|0.4||||0.72|TWO_SIDED|95.0|-1.5|2.1|||Van Elteren test||Difference between arms in the percentage of subjects with inpatient mortality within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||2.1|-1.5|.72
71774167|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.01||||0.9767|TWO_SIDED|95.0|-0.78|0.76||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 2.5 hours||0.76|-0.78|0.9767
71774168|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Median Difference (Net)|0.32||||0.3964|TWO_SIDED|95.0|-0.44|1.09||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3 hours||1.09|-0.44|0.3964
71774169|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|0.22||||0.5669|TWO_SIDED|95.0|-0.55|0.98||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 3.5 hours||0.98|-0.55|0.5669
71774170|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.7006|TWO_SIDED|95.0|-0.91|0.62||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 4 hours||0.62|-0.91|0.7006
71774171|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.1||||0.794|TWO_SIDED|95.0|-0.87|0.67||No adjustment for multiple comparisons was made due to the exploratory nature of the study.|Mixed Models Analysis||Difference is LAT8881 minus placebo.|Change from baseline VAS score at 5 hours||0.67|-0.87|0.7940
71774172|NCT05298306|143048307|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Analysis was based a mixed model repeated measures model, with fixed-effects including treatment, time point and period factors. Baseline was included as a covariate. Random effects for participants and participant by period were also included.|Mean Difference (Net)|-0.15||||0.6892|TWO_SIDED|95.0|-0.92|0.61|||Mixed Models Analysis|No adjustment for multiple comparisons was made due to the exploratory nature of the study.||Change from baseline VAS score at 6 hours|Difference is LAT8881 minus placebo.|0.61|-0.92|0.6892
71774173|NCT01352468|143048343|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|Controlling for baseline scores||||||.35
71774174|NCT01352468|143048344|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|Controlling for baseline scores||||||.68
71774175|NCT01352468|143048345|SUPERIORITY_OR_OTHER|||||||0.57|||||||ANCOVA|Controlling for baseline scores||||||.57
71774176|NCT01178073|143048346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.502||||0.0002|TWO_SIDED|95.0|0.348|0.724|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.724|0.348|0.0002
71774177|NCT01178073|143048346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.477||||0.0004|TWO_SIDED|95.0|0.314|0.723|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||0.723|0.314|0.0004
71774178|NCT01178073|143048346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.528||||0.0045|TWO_SIDED|95.0|0.338|0.827|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||0.827|0.338|0.0045
71832843|NCT04040296|143169925|SUPERIORITY||Difference in percentage|1.9||||0.31|TWO_SIDED|95.0|-0.3|4.1|||Van Elteren test||Difference between arms in the percentage of subjects who received a kidney consult within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||4.1|-.3|.31
71832844|NCT04040296|143169926|SUPERIORITY||Difference in percentage|-0.9||||0.17|TWO_SIDED|95.0|-2.3|0.4|||Van Elteren test||Difference between arms in the percentage of subjects discharged to hospice care within 14 days of randomization.|Proportions were compared using Cochrane-Mantel Haenszel χ2 test, accounting for stratification by hospital site.||.4|-2.3|.17
71832845|NCT02549170|143169927|SUPERIORITY||Newcombe confidence interval|-21.8|||=|0.0045|TWO_SIDED|95.0|-34.45|-7.94|||Chi-squared|||||-7.94|-34.45|=0.0045
71832846|NCT02549170|143169929|SUPERIORITY||Newcombe confidence interval|-16.9|||=|0.0896|TWO_SIDED|95.0|-33.02|0.69||The treatment groups were compared using a continuity-corrected chi-square test.|Chi-squared, Corrected|||||0.69|-33.02|=0.0896
71832847|NCT02549170|143169930|SUPERIORITY||||||=|0.002|||||||Wilcoxon Survival Test|||||||=0.002
71832848|NCT02549170|143169931|SUPERIORITY||Least Square Mean|5.2|||=|0.03|TWO_SIDED|95.0|0.5|9.9|||ANCOVA|||||9.9|0.5|=0.030
71832849|NCT01266122|143169976|SUPERIORITY_OR_OTHER||log(Incident Risk Ratio)|-0.95|||<|0.001|TWO_SIDED|95.0|-1.47|-0.44|||Mixed Models Analysis|Mixed effects Poisson regression||Intent to treat analysis||-.44|-1.47|<.001
71832850|NCT01266122|143169977|SUPERIORITY_OR_OTHER||Chi-square statistic|1.39|||=|0.239|TWO_SIDED||||||Chi-squared|||Intent to treat analysis.||||=.239
71660271|NCT05538065|142834882|SUPERIORITY||Risk Ratio (RR)|1.26||||0.039|TWO_SIDED|95.0|1.01|1.57||Adjusted for multiple comparisons|Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and binary errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||1.57|1.01|0.039
71736470|NCT02684188|142987407|SUPERIORITY|||||||0.806|||||||ANCOVA|||The following hypotheses were tested: H0: There is no difference in the mean CTM3 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean CTM3 rating than patients in the standard discharge group.|An analysis of covariance was used to model the CTM3 discharge planning score as a function of treatment group. An ANOVA F-test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of patient age and income. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, County, Number in Household, LACE+ score, and PAM10 score did not differ in their mean CTM3 scores so were not retained in the model.|||0.806
71736471|NCT02684188|142987408|SUPERIORITY|||||||0.742|||||||ANOVA|||The following hypotheses were tested: H0: There is no difference in the mean RTM14 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean RTM14 rating than patients in the standard discharge group.|A repeated measures ANOVA model (over the 6 time measurement periods) was used to model the RTM14 score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and whether or not a patient had visited a hospital or ED prior to that day. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values \< 0.05 were considered statistically significant. The covariates Sex, Number in household, LACE+ score, and PAM10 score were not significant in explaining SF-12 scores so were not retained in the model.|||0.742
71736472|NCT02684188|142987409|SUPERIORITY|||||||0.717||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.|||0.717
71736473|NCT02684188|142987409|SUPERIORITY|||||||0.479||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.|||0.479
71736474|NCT02684188|142987409|SUPERIORITY|||||||0.329|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.|||0.329
71736475|NCT02684188|142987409|SUPERIORITY|||||||0.78|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|This Hypothesis was tested with no adjustments for covariates since none were significant.|||0.780
71660272|NCT05538065|142834883|SUPERIORITY||Mean Difference (Final Values)|29.0||||0.386|TWO_SIDED|95.0|-36.6|94.6||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||94.6|-36.6|0.386
71660273|NCT05538065|142834883|SUPERIORITY||Mean Difference (Final Values)|38.1||||272|TWO_SIDED|95.0|-29.9|106.1||Adjusted for multiple comparisons|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||106.1|-29.9|272
71736476|NCT02684188|142987409|SUPERIORITY|||||||0.779||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.|||0.779
71736477|NCT02684188|142987409|SUPERIORITY|||||||0.848||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.|||0.848
71736478|NCT02684188|142987409|SUPERIORITY|||||||0.857||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.|||0.857
71736479|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|1097.0||||||90.0|793.6|1461.0||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||1461|793.6|
71774179|NCT01178073|143048347|SUPERIORITY_OR_OTHER||Mean Percent Difference|-33.81|||<|0.0001|TWO_SIDED|95.0|-44.78|-20.66|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||-20.66|-44.78|<0.0001
71774180|NCT01178073|143048347|SUPERIORITY_OR_OTHER||Mean Percent Difference|-25.09||||0.0111|TWO_SIDED|95.0|-40.04|-6.4|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||-6.40|-40.04|0.0111
71832851|NCT03756571|143169979|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71736480|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|54.6||||||90.0|35.36|85.49||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||85.49|35.36|
71736481|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|79.81|142.0||P-Values were not calculated.|||This analysis is for Serotype 9V|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||142.0|79.81|
71774181|NCT01178073|143048347|SUPERIORITY_OR_OTHER||Mean Percent Difference|-41.51|||<|0.0001|TWO_SIDED|95.0|-53.16|-26.97|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||-26.97|-53.16|<0.0001
71774182|NCT01178073|143048348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0264|TWO_SIDED|95.0|1.054|2.319|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.|||2.319|1.054|0.0264
71774183|NCT01178073|143048348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.424||||0.1518|TWO_SIDED|95.0|0.878|2.308|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.|||2.308|0.878|0.1518
71774184|NCT01178073|143048348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.723||||0.0321|TWO_SIDED|95.0|1.047|2.833|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.|||2.833|1.047|0.0321
71774185|NCT01178073|143048349|SUPERIORITY_OR_OTHER||Median Difference|22.75|||<|0.0001|TWO_SIDED|95.0|12.0|33.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||33.50|12.00|<0.0001
71774186|NCT01178073|143048349|SUPERIORITY_OR_OTHER||Median Difference|24.75||||0.0005|TWO_SIDED|95.0|11.0|38.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||38.50|11.00|0.0005
71774187|NCT01178073|143048349|SUPERIORITY_OR_OTHER||Median Difference|20.85||||0.003|TWO_SIDED|95.0|8.0|33.7|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||33.70|8.00|0.0030
71774188|NCT01178073|143048350|SUPERIORITY_OR_OTHER||Median Difference|0.0||||0.2287|TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.0|0.0|0.2287
71774189|NCT01178073|143048350|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.0|0.0|
71774190|NCT01178073|143048350|SUPERIORITY_OR_OTHER||Median Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test|This comparison was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.0|0.0|
71774191|NCT01178073|143048351|SUPERIORITY_OR_OTHER||Median Difference|-0.38|||||TWO_SIDED|95.0|-0.75|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.|||0.00|-0.75|
71774192|NCT01178073|143048351|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.|||0.00|-1.00|
71774193|NCT01178073|143048351|SUPERIORITY_OR_OTHER||Median Difference|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||Stratified Wilcoxon Rank Sum Test|This endpoint was not formally tested according to the pre-defined hierarchical testing procedure.|Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.|||0.00|-1.00|
71774194|NCT03496571|143048397|SUPERIORITY||LSM Difference from Placebo|-95.0|||<|0.001|TWO_SIDED|95.0|-122.0|-68.0|||ANCOVA|||||-68|-122|<0.001
71774195|NCT03496571|143048397|SUPERIORITY||LSM Difference from Placebo|-102.0|||<|0.001|TWO_SIDED|95.0|-128.0|-76.0|||ANCOVA|||||-76|-128|<0.001
71774196|NCT03496571|143048397|SUPERIORITY||LSM Difference from Placebo|-98.0|||<|0.001|TWO_SIDED|95.0|-121.0|-76.0|||ANCOVA|||||-76|-121|<0.001
71774197|NCT03496571|143048398|SUPERIORITY||Percent Difference from Placebo|55.0|||<|0.001|TWO_SIDED|95.0|27.0|76.0|||Fisher Exact|||||76|27|<0.001
71774198|NCT03496571|143048398|SUPERIORITY||Percent Difference from Placebo|62.0|||<|0.001|TWO_SIDED|95.0|34.0|82.0|||Fisher Exact|||||82|34|<0.001
71774199|NCT03496571|143048398|SUPERIORITY||Percent Difference from Placebo|58.0|||<|0.001|TWO_SIDED|95.0|36.0|74.0|||Fisher Exact|||||74|36|<0.001
71774200|NCT03496571|143048399|SUPERIORITY||LSM Difference from Placebo|-20.0||||0.05|TWO_SIDED|95.0|-40.0|0.0|||ANCOVA|||||0|-40|0.05
71774201|NCT03496571|143048399|SUPERIORITY||LSM Difference from Placebo|-33.0||||0.002|TWO_SIDED|95.0|-53.0|-13.0|||ANCOVA|||||-13|-53|0.002
71774202|NCT03496571|143048399|SUPERIORITY||LSM Difference from Placebo|-26.0||||0.004|TWO_SIDED|95.0|-44.0|-9.0|||ANCOVA|||||-9|-44|0.004
71832852|NCT03756571|143169980|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
71832853|NCT03756571|143169981|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71736482|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|134.3||||||90.0|80.83|197.1||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||197.1|80.83|
71736483|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|200.3||||||90.0|151.9|302.4||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||302.4|151.9|
71736484|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|181.3||||||90.0|119.8|253.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||253.1|119.8|
71736485|NCT00488826|142987410|SUPERIORITY_OR_OTHER||Geometric mean ratio|90.02||||||90.0|57.93|150.5||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||150.5|57.93|
71736486|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|665.1||||||90.0|473.3|851.2||P-Values were not calculated.|||This analysis is for Serotype 4.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||851.2|473.3|
71736487|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|22.2||||||90.0|13.99|31.77||P-Values were not calculated.|||This analysis is for Serotype 6B.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||31.77|13.99|
71736488|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|73.7||||||90.0|56.41|103.6||P-Values were not calculated.|||This analysis is for Serotype 9V.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||103.6|56.41|
71774203|NCT01226043|143048414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|2.15|2.44|||ANOVA|The last observation carried forward (LOCF) method was applied to impute missing Week 4 overall patient preference values for ANOVA analysis.||The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.||2.44|2.15|<0.0001
71774204|NCT00910988|143048426|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This p-value corresponds to the two way interaction between time and order and is not adjusted for multiple comparisons. The a priori threshold for statistical significance is alpha equal to 0.05. There was no 3 way interaction.|ANCOVA|Repeated measures ANCOVA with time as the repeated measure, drug assignment as a fixed factor, and order as a fixed factor.||The hypothesis being tested is whether there is a significant effect of one or both antipsychotics on whole body insulin sensitivity. Sample size was calculated using power calculations to detect significant effects of treatment on insulin sensitivity. Drug assignment is a 2-level fixed factor (olanzapine vs ziprasidone) as is order (drug first vs placebo first). Baseline of the dependent variable as well as baseline DEXA total fat were entered into the model as covariates.||||0.001
71774205|NCT00910988|143048429|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||This p-value corresponds to the 3 way interaction between time, drug (olanzapine vs ziprasidone), and order (drug first vs placebo first) and is not adjusted for multiple comparisons.|ANCOVA|||The null hypothesis is that olanzapine and ziprasidone would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue, which was measured by evaluating the rate of appearance of labeled glycerol. The alternative hypothesis is that olanzapine, but not ziprasidone, would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue.||||0.57
71774206|NCT00191646|143048487|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||Log Rank|||Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.||||0.199
71774207|NCT00191646|143048488|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||||||0.771
71774208|NCT00191646|143048488|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||Fisher Exact|||||||0.784
71774209|NCT00191646|143048489|SUPERIORITY_OR_OTHER|||||||0.621||95.0|||||Log Rank|||||||0.621
71774210|NCT00191646|143048490|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Log Rank|||||||0.013
71832854|NCT03756571|143169982|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71832855|NCT03756571|143169983|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71832856|NCT03756571|143169984|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71736489|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|99.48||||||90.0|61.09|147.5||P-Values were not calculated.|||This analysis is for Serotype 14.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||147.5|61.09|
71736490|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|164.0||||||90.0|114.9|232.9||P-Values were not calculated.|||This analysis is for Serotype 18C.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||232.9|114.9|
71774211|NCT03911843|143048523|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0||||the p-value of significance was calculated using the analysis system|Wilcoxon (Mann-Whitney)|||||||<0.05
71736491|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.45||||||90.0|57.98|119.1||P-Values were not calculated.|||This analysis is for Serotype 19F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||119.1|57.98|
71736492|NCT00488826|142987411|SUPERIORITY_OR_OTHER||Geometric mean ratio|44.7||||||90.0|29.48|68.71||P-Values were not calculated.|||This analysis is for Serotype 23F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."||68.71|29.48|
71736493|NCT01854281|142987491|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||0.02
71736494|NCT01854281|142987491|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.||||<0.01
71774212|NCT03911843|143048523|SUPERIORITY||Mean Difference (Net)|-0.14|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71832857|NCT03756571|143169985|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
71832858|NCT03756571|143169986|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
71832859|NCT03756571|143169987|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71832860|NCT03756571|143169988|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
71832861|NCT03756571|143169989|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71832862|NCT03756571|143169990|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71832863|NCT03224390|143170005|SUPERIORITY||Instrumental variables estimate|0.41|||||TWO_SIDED|95.0|-0.03|0.85||||||||.85|-.03|
71832864|NCT00396084|143170010|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 4 treatment groups over the 7 days of study drug administration||||<0.001
71774213|NCT03911843|143048524|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71774214|NCT03911843|143048525|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71774215|NCT01907100|143048526|OTHER||Hazard Ratio (HR)|0.555||||0.0174|TWO_SIDED|95.0|0.34|0.907|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II Part||0.907|0.340|0.0174
71832865|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.041
71736495|NCT03208088|142987492|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|95.0|0.1|11.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 1 - Control.|||11.6|0.1|
71736496|NCT03208088|142987492|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-4.0|8.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 2 - Control.|||8.1|-4.0|
71736497|NCT03208088|142987493|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-7.5|4.6|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 3 - Control.|||4.6|-7.5|
71736498|NCT03208088|142987493|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least Square Mean|-3.4|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-9.0|2.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test 4 - Control.|||2.3|-9.0|
71774216|NCT01907100|143048526|OTHER||Hazard Ratio (HR)|1.01||||0.543|TWO_SIDED|95.0|0.79|1.3||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III part:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.30|0.79|0.5430
71832866|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.008
71832867|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.012
71832868|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.01
71736499|NCT00238238|142987498|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher Exact|||||||0.29
71736500|NCT00238238|142987499|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
71736501|NCT01345669|142987500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.126||||0.4806|TWO_SIDED|95.0|0.809|1.569|||Log Rank||Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.||1.569|0.809|0.4806
71774217|NCT01907100|143048527|OTHER||Hazard Ratio (HR)|0.782||||0.4132|TWO_SIDED|95.0|0.433|1.412|||Proportional hazards mode||Hazard ratio, confidence interval and p-value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II||1.412|0.433|0.4132
71774218|NCT01907100|143048527|OTHER||Hazard Ratio (HR)|1.12||||0.7306|TWO_SIDED|95.0|0.79|1.58||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p-value obtained from a non-stratified proportional hazards model.|"Phase III:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."||1.58|0.79|0.7306
71736502|NCT01345669|142987501|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier estimates|-6.27||||0.161|TWO_SIDED|95.0|-15.04|2.5|||Log Rank||Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.|Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated||2.50|-15.04|0.1610
71736503|NCT01345669|142987502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.444||||0.1301|TWO_SIDED|95.0|0.895|2.332||p-value (two-sided) from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.332|0.895|0.1301
71736504|NCT01345669|142987503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.431||||0.0561|TWO_SIDED|95.0|0.991|2.068|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Swallowing (Q5-Q8 from QLQ-HN35).||2.068|0.991|0.0561
71832869|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.03
71832870|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.091
71832871|NCT00396084|143170010|SUPERIORITY_OR_OTHER|||||||0.354||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.||||0.354
71660274|NCT05538065|142834884|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.657|TWO_SIDED|95.0|-74.5|47.0||Adjusted for multiple testing|Regression, Linear|||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||47.0|-74.5|0.657
71660275|NCT05538065|142834884|SUPERIORITY||Mean Difference (Final Values)|15.1||||0.696|TWO_SIDED|95.0|-60.7|91.0|||Regression, Linear|Adjusted for multiple testing||Outcomes were evaluated using generalized estimating equations with an identity link and normally-distributed errors, adjusting for provider-level clustering and Holm-Bonferroni multiple comparisons.||91.0|-60.7|0.696
71736505|NCT01345669|142987503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.446||||0.0523|TWO_SIDED|95.0|0.996|2.098|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Pain HN35 (Q1-Q4 from QLQ-HN35).||2.098|0.996|0.0523
71774219|NCT01907100|143048528|OTHER||Odds Ratio (OR)|1.09||||0.3189|TWO_SIDED|95.0|0.76|1.58||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||Exact 95% CI by Clopper and Pearson.|1.58|0.76|0.3189
71736506|NCT01345669|142987503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.257|TWO_SIDED|95.0|0.577|1.158|||Regression, Logistic|||Odds ratio and p-value from logistic regression analysis of 'improved vs. not improved' stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3) for Global health status/QoL(Q29-Q30 from QLQ-C30).||1.158|0.577|0.2570
71736507|NCT01345669|142987504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.295||||0.0591|TWO_SIDED|95.0|0.986|1.7||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.700|0.986|0.0591
71736508|NCT01345669|142987504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.456||||0.0049|TWO_SIDED|95.0|1.113|1.905||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||1.905|1.113|0.0049
71660276|NCT02213510|142834899|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71660277|NCT02213510|142834900|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||t-test, 2 sided|||||||0.655
71660278|NCT02213510|142834901|SUPERIORITY_OR_OTHER|||||||0.811|TWO_SIDED||||||t-test, 2 sided|||||||0.811
71660279|NCT02213510|142834902|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
71660280|NCT02213510|142834903|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||t-test, 2 sided|||||||0.462
71660281|NCT02213510|142834904|SUPERIORITY_OR_OTHER|||||||0.646|TWO_SIDED||||||t-test, 2 sided|||||||0.646
71660282|NCT02213510|142834905|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.510
71660283|NCT02213510|142834906|SUPERIORITY_OR_OTHER|||||||0.651|TWO_SIDED||||||t-test, 2 sided|||||||0.651
71660284|NCT02213510|142834907|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.588
71736509|NCT01345669|142987504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.604||||0.0002|TWO_SIDED|95.0|1.238|2.079||P-value from log-rank test stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Log Rank|||For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).||2.079|1.238|0.0002
71736510|NCT01345669|142987505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.2232|TWO_SIDED|95.0|-0.81|3.45|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||3.45|-0.81|0.2232
71736511|NCT01345669|142987505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.08||0.0028|TWO_SIDED|95.0|1.12|5.36|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||5.36|1.12|0.0028
71774220|NCT01907100|143048529|OTHER||Odds Ratio (OR)|0.79||||0.7512|TWO_SIDED|95.0|0.4|1.55||one-sided p-value|Regression, Logistic|Odds ratio and one-sided p-value are obtained from an un-adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.|||1.55|0.40|0.7512
71736512|NCT01345669|142987505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.98||0.0005|TWO_SIDED|95.0|-5.33|-1.49|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0-N2a or N2b-N3).|Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.||-1.49|-5.33|0.0005
71736513|NCT01793883|142987506|SUPERIORITY|||||||0.251|||||||Log Rank|||||||0.251
71736514|NCT01793883|142987506|SUPERIORITY|||||||0.818|||||||Log Rank|||||||0.818
71736515|NCT02478255|142987507|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71736516|NCT00516165|142987512|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kaplan Meier|||||||0.05
71736517|NCT00516165|142987513|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
71736518|NCT00516165|142987514|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||||||<0.05
71736519|NCT00516165|142987515|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71736520|NCT00516165|142987516|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71736521|NCT00516165|142987517|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Kaplan-Meier|||||||0.05
71832872|NCT00396084|143170014|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 4 treatment groups were compared.||||0.05
71660285|NCT02213510|142834908|SUPERIORITY_OR_OTHER|||||||0.858|TWO_SIDED||||||t-test, 2 sided|||||||0.858
71660286|NCT02213510|142834909|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||||||1.00
71660287|NCT05958888|142834917|SUPERIORITY||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<0.001
71736522|NCT00061633|142987524|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.||||||0.5289|||||||2-sided 95% confidence interval|||95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference||||0.5289
71736523|NCT01431963|142987525|SUPERIORITY_OR_OTHER||percentage of participants|43.1|||||TWO_SIDED|95.0|30.85|55.96|||||The estimated value reflects the percentage of participants who were seizure free for all seizures.|||55.96|30.85|
71736524|NCT01431963|142987525|SUPERIORITY_OR_OTHER||percentage of participants|40.0|||||TWO_SIDED|95.0|27.02|54.09|||||The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.|||54.09|27.02|
71736525|NCT01431963|142987525|SUPERIORITY_OR_OTHER||percentage of participants|40.5|||||TWO_SIDED|95.0|25.63|56.72|||||The estimated value reflects the percentage of participants who were seizure free for A+B seizures.|||56.72|25.63|
71660288|NCT05958888|142834917|SUPERIORITY||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome.The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<0.001
71660289|NCT05958888|142834917|SUPERIORITY||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71660290|NCT05958888|142834917|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.10
71660291|NCT05958888|142834917|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
71736526|NCT01431963|142987525|SUPERIORITY_OR_OTHER||percentage of participants|69.7|||||TWO_SIDED|95.0|51.29|84.41|||||The estimated value reflects the percentage of participants who were seizure free for C seizures.|||84.41|51.29|
71736527|NCT01431963|142987525|SUPERIORITY_OR_OTHER||percentage of participants|80.0|||||TWO_SIDED|95.0|44.39|97.48|||||The estimated value reflects the percentage of participants who were seizure free for D5 seizures.|||97.48|44.39|
71736528|NCT02921087|142987532|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.07
71736529|NCT02921087|142987534|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.01
71736530|NCT02921087|142987535|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.77
71736531|NCT02921087|142987536|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.69
71736532|NCT02921087|142987537|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.||||0.87
71736533|NCT03109184|142987602|SUPERIORITY||Odds Ratio (OR)|1.21|||||TWO_SIDED||||||||3-Month follow-up between groups odds ratio of DV perpetration|||||
71736534|NCT03109184|142987602|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED||||||||9-month follow-up between group odds ratio of DV perpetration|||||
71736535|NCT03109184|142987602|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED||||||||3-month follow-up between groups odds ratio of DV victimization|||||
71736536|NCT03109184|142987602|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED||||||||9-month follow-up between groups odds ratio of DV victimization|||||
71736537|NCT03109184|142987603|SUPERIORITY||Effect Size (d)|-0.07|||||TWO_SIDED||||||||3-month follow-up between groups effect size of general aggression|||||
71736538|NCT03109184|142987603|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of general aggression|||||
71736539|NCT03109184|142987604|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent attitudes support aggression|||||
71736540|NCT03109184|142987604|SUPERIORITY||Effect Size (d)|-0.17|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent attitudes support aggression|||||
71736541|NCT03109184|142987604|SUPERIORITY||Effect Size (d)|0.19|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent attitudes support aggression|||||
71736542|NCT03109184|142987604|SUPERIORITY||Effect Size (d)|0.2|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent attitudes support aggression|||||
71736543|NCT03109184|142987605|SUPERIORITY||Effect Size (d)|0.09|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent short-term self-regulation|||||
71736544|NCT03109184|142987605|SUPERIORITY||Effect Size (d)|0.36|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent short-term self-regulation|||||
71736545|NCT03109184|142987605|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent long-term self-regulation|||||
71736546|NCT03109184|142987605|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent long-term self-regulation|||||
71736547|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported open family communication|||||
71774221|NCT02103218|143048530|SUPERIORITY|||||||0.62|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.62
71774222|NCT02103218|143048531|SUPERIORITY|||||||0.15|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.15
71774223|NCT02103218|143048532|SUPERIORITY|||||||0.47|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.47
71774224|NCT02103218|143048533|SUPERIORITY|||||||0.29|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
71774225|NCT02103218|143048534|SUPERIORITY||||||<|0.001|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||<0.001
71774226|NCT02103218|143048535|SUPERIORITY|||||||0.02||||||Omnibus overall test for any group x time interaction was p = 0.77.|linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.02
71890235|NCT01813890|143302104|SUPERIORITY_OR_OTHER||Median Difference (Net)|126.58||||0.004|TWO_SIDED|95.0|49.5|203.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.||203.7|49.5|0.004
71890236|NCT03952559|143302112|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7261|TWO_SIDED|95.0|0.58|2.21|||Regression, Logistic|||||2.21|0.58|0.7261
71736548|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported open family communication|||||
71736549|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported problems in family communication|||||
71736550|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.06|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported problems in family communication|||||
71736551|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.62|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
71736552|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.13|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed|||||
71736553|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported open family communication|||||
71736554|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.01|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported open family communication|||||
71736555|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|-0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported problems in family communication|||||
71736556|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.25|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported problems in family communication|||||
71736557|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|0.66|||||TWO_SIDED||||||||3-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
71736558|NCT03109184|142987606|SUPERIORITY||Effect Size (d)|-0.1|||||TWO_SIDED||||||||9-month follow-up between groups effect size of parent reported number of relationship topics discussed|||||
71736559|NCT03109184|142987607|SUPERIORITY||Effect Size (d)|0.15|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent emotion-regulation|||||
71736560|NCT03109184|142987607|SUPERIORITY||Effect Size (d)|0.32|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent emotion-regulation|||||
71736561|NCT03109184|142987608|SUPERIORITY||Effect Size (d)|-0.11|||||TWO_SIDED||||||||3-month follow-up between groups effect size of adolescent distress tolerance|||||
71736562|NCT03109184|142987608|SUPERIORITY||Effect Size (d)|0.23|||||TWO_SIDED||||||||9-month follow-up between groups effect size of adolescent distress tolerance|||||
71736563|NCT00602420|142987609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67||||0.037|TWO_SIDED|95.0|0.1|3.24|||t-test, 2 sided|||Tested at the two-sided 0.05 significance level.||3.24|0.10|0.037
71736564|NCT00602420|142987609|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Tested at the two-sided 0.05 significance level.||||0.007
71736565|NCT02008227|142987724|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0003|TWO_SIDED|95.0|0.62|0.87|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.87|0.62|0.0003
71736566|NCT02008227|142987724|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||Unstratified Analysis||0.86|0.62|0.0002
71736567|NCT02008227|142987725|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0102|TWO_SIDED|95.0|0.58|0.93|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.58|0.0102
71774227|NCT02103218|143048536|SUPERIORITY|||||||0.67|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.67
71774228|NCT02103218|143048537|SUPERIORITY|||||||0.45|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.45
71774229|NCT02103218|143048538|SUPERIORITY|||||||0.7|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
71774230|NCT02103218|143048539|SUPERIORITY|||||||0.42|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.42
71890237|NCT03952559|143302112|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0718|TWO_SIDED|95.0|0.95|3.41|||Regression, Logistic|||||3.41|0.95|0.0718
71660292|NCT05958888|142834917|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.25|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.25
71736568|NCT02008227|142987725|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0052|TWO_SIDED|95.0|0.58|0.91|||Log Rank|||Unstratified Analysis||0.91|0.58|0.0052
71736569|NCT02008227|142987728|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.4928|TWO_SIDED|95.0|0.82|1.1|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.10|0.82|0.4928
71736570|NCT02008227|142987728|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.3596|TWO_SIDED|95.0|0.81|1.08|||Log Rank|||Unstratified Analysis||1.08|0.81|0.3596
71736571|NCT02008227|142987729|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3806|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||1.12|0.74|0.3806
71736572|NCT02008227|142987729|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3249|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||Unstratified Analysis||1.10|0.74|0.3249
71736573|NCT02008227|142987732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.55|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.55|0.18|<0.0001
71736574|NCT02008227|142987732|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.55|||Log Rank|||Unstratified Analysis||0.55|0.21|<0.0001
71736575|NCT02008227|142987733|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31||||0.0006|TWO_SIDED|95.0|0.15|0.62|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.62|0.15|0.0006
71736576|NCT02008227|142987733|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.38||||0.0003|TWO_SIDED|95.0|0.22|0.65|||Log Rank|||Unstratified Analysis||0.65|0.22|0.0003
71736577|NCT02008227|142987737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.0111|TWO_SIDED|95.0|0.55|0.93|||Log Rank|||Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.||0.93|0.55|0.0111
71736578|NCT02008227|142987737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.6305|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Cough: Unstratified Analysis||1.33|0.84|0.6305
71736579|NCT02008227|142987737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7406|TWO_SIDED|95.0|0.81|1.16|||Log Rank|||Dyspnea: Unstratified Analysis||1.16|0.81|0.7406
71736580|NCT02008227|142987737|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.5221|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||Arm/Shoulder Pain||1.17|0.73|0.5221
71736581|NCT02008227|142987752|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0012|TWO_SIDED|95.0|0.7|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.70|0.0012
71736582|NCT02008227|142987753|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0045|TWO_SIDED|95.0|0.64|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.92|0.64|0.0045
71660293|NCT05958888|142834918|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71889953|NCT03575104|143301811|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-6.45||||0.0303|TWO_SIDED|95.0|-12.282|-0.614||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.025; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||-0.614|-12.282|0.0303
71890238|NCT03952559|143302112|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.0001|TWO_SIDED|95.0|2.02|6.89|||Regression, Logistic|||||6.89|2.02|<0.0001
71660294|NCT05958888|142834918|SUPERIORITY||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71736583|NCT02008227|142987754|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.0012|TWO_SIDED|95.0|0.49|0.84|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.84|0.49|0.0012
71736584|NCT02008227|142987755|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.68|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).||0.68|0.30|<0.0001
71774231|NCT02103218|143048540|SUPERIORITY|||||||0.63|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.63
71832873|NCT00396084|143170014|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against gatifloxacin using a simultaneous non-parametric procedure.||||0.01
71832874|NCT00396084|143170014|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against moxifloxacin using a simultaneous non-parametric procedure.||||0.02
71832875|NCT00396084|143170014|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against levofloxacin using a simultaneous non-parametric procedure.||||0.14
71832876|NCT00396084|143170015|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Mean values of EBA Days 2 to 7 for the 4 treatment groups were compared.||||0.51
71832877|NCT00396084|143170015|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||The rate of fall in sputum cfu for the 4 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.16
71660295|NCT05958888|142834918|SUPERIORITY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71736585|NCT02008227|142987756|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard Ratio|0.96||||0.4981|TWO_SIDED|95.0|0.85|1.08|||Log Rank|||||1.08|0.85|0.4981
71832878|NCT00396084|143170015|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for patients in the 3 fluoroquinolone groups were pooled and compared to bactericidal activity of patients in the INH arm.||||0.036
71832879|NCT00396084|143170016|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 3 treatment groups over the 7 days of study drug administration||||<0.001
71890239|NCT03952559|143302115|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9615|TWO_SIDED|95.0|0.59|1.74|||Regression, Logistic|||||1.74|0.59|0.9615
71736586|NCT02008227|142987758|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Hazard Ratio|0.32|||||TWO_SIDED|95.0|0.21|0.48||||||||0.48|0.21|
71736587|NCT03354273|142987770|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Sensitivity||||<0.0001
71736588|NCT03354273|142987770|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0182|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 1: Specificity||||0.0182
71736589|NCT03354273|142987770|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Sensitivity||||<0.0001
71736590|NCT03354273|142987770|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0002|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 2: Specificity||||0.0002
71736591|NCT03354273|142987770|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Sensitivity||||<0.0001
71832880|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.023
71832881|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.018
71832882|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.03
71736592|NCT03354273|142987770|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.997|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Reader 3: Specificity||||0.9970
71736593|NCT03354273|142987770|OTHER|Sensitivity was compared to a pre-specified threshold of 60%.|||||<|0.0001|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Sensitivity||||<0.0001
71832883|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.012
71736594|NCT03354273|142987770|OTHER|Specificity was compared to a pre-specified threshold of 60%.||||||0.0781|||||||One-sided z-tests|The hypothesis tests were one-sided z-tests with a significance level of 0.025.||Majority Rule: Specificity||||0.0781
71736595|NCT03354273|142987771|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|14.5|||<|0.0001|TWO_SIDED|95.0|6.5|22.4|||McNemar|The hypothesis tests were 1-sided McNemar's tests with a significance level of 0.025 for sensitivity.||Reader 1: Sensitivity||22.4|6.5|<0.0001
71736596|NCT03354273|142987771|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.4||||0.0004|TWO_SIDED|95.0|-4.9|9.7|||Nam's RMLE|||Reader 1: Specificity||9.7|-4.9|0.0004
71832884|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
71832885|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.003
71832886|NCT00396084|143170016|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.||||0.004
71832887|NCT00396084|143170017|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 3 treatments groups were compared.||||<0.01
71660296|NCT05958888|142834918|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.85||0.12|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.12
71736597|NCT03354273|142987771|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.9||||0.0002|TWO_SIDED|95.0|4.7|21.0|||McNemar|||Reader 2: Sensitivity||21.0|4.7|0.0002
71736598|NCT03354273|142987771|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|4.9|||<|0.0001|TWO_SIDED|95.0|-2.1|11.8|||Nam's RMLE|||Reader 2: Specificity||11.8|-2.1|<0.0001
71736599|NCT03354273|142987771|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.3|||<|0.0001|TWO_SIDED|95.0|6.6|19.9|||McNemar|||Reader 3: Sensitivity||19.9|6.6|<0.0001
71736600|NCT03354273|142987771|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|1.2||||0.0011|TWO_SIDED|95.0|-6.0|8.4|||Nam's RMLE|||Reader 3: Specificity||8.4|-6.0|0.0011
71736601|NCT03354273|142987771|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.6||||0.0003|TWO_SIDED|95.0|4.1|19.2|||McNemar|||Majority Rule: Sensitivity||19.2|4.1|0.0003
71736602|NCT03354273|142987771|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.1||||0.0004|TWO_SIDED|95.0|-5.0|9.3|||Nam's RMLE|||Majority Rule: Specificity||9.3|-5.0|0.0004
71736603|NCT03354273|142987772|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|24.4||||0.0127|TWO_SIDED|95.0|5.4|43.4|||McNemar|||Reader 1: Sensitivity||43.4|5.4|0.0127
71736604|NCT03354273|142987772|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.5||||0.0001|TWO_SIDED|95.0|-1.2|20.2|||Nam's RMLE|||Reader 1: Specificity||20.2|-1.2|0.0001
71832888|NCT00396084|143170017|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against Linezolid once daily using a simultaneous non-parametric procedure.||||<0.01
71832889|NCT00396084|143170017|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Mean EBA 0-2 of INH was compared to pooled Linezolid once daily and Linezolid twice daily results.||||<0.01
71832890|NCT00396084|143170020|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANOVA|||Mean values EBA Days 2-7 for the 3 treatment groups were compared.||||0.25
71832891|NCT00396084|143170020|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||The rate of fall in sputum cfu for the 3 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.||||0.42
71832892|NCT00396084|143170020|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for INH was compared to that of the pooled linezolid arms.||||0.14
71774232|NCT02103218|143048541|SUPERIORITY|||||||0.05||||||Omnibus overall test for any group x time interaction was p = 0.78.|count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.05
71774233|NCT02103218|143048542|SUPERIORITY|||||||0.5|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.50
71774234|NCT02103218|143048544|SUPERIORITY|||||||0.86|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.86
71774235|NCT02103218|143048545|SUPERIORITY|||||||0.46|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.46
71774236|NCT02103218|143048546|SUPERIORITY|||||||0.7|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.70
71774237|NCT02103218|143048547|SUPERIORITY|||||||0.29|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.29
71774238|NCT02103218|143048548|SUPERIORITY|||||||0.43|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.||||0.43
71774239|NCT00644228|143048557|SUPERIORITY||Hazard Ratio (HR)|0.712||||0.0018|TWO_SIDED|96.0|0.56|0.906||The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.||0.906|0.560|0.0018
71774240|NCT00644228|143048558|SUPERIORITY||Hazard Ratio (HR)|0.709||||0.025|TWO_SIDED|95.0|0.524|0.959||The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|Overall survival will be compared between the two treatment arms using a stratified log-rank test.||0.959|0.524|0.0250
71774241|NCT00644228|143048559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Cochran-Mantel-Haenszel|||||||0.20
71774242|NCT02567552|143048568|OTHER|||||||0.3395|||||||Chi-squared|||||||0.3395
71774243|NCT02567552|143048569|OTHER|||||||0.1523|||||||Chi-squared|||||||0.1523
71774244|NCT02567552|143048570|OTHER|||||||0.1189|||||||t-test, 2 sided|||comparison between groups||||0.1189
71774245|NCT02567552|143048572|OTHER|||||||0.2042|||||||t-test, 2 sided|||||||0.2042
71774246|NCT02567552|143048573|OTHER|||||||0.6262|||||||t-test, 2 sided|||||||0.6262
71774247|NCT02567552|143048574|OTHER|||||||0.2301|||||||t-test, 2 sided|||||||0.2301
71774248|NCT02567552|143048575|OTHER|||||||0.5118|||||||t-test, 2 sided|||||||0.5118
71774249|NCT02567552|143048576|OTHER|||||||0.8371|||||||t-test, 2 sided|||||||0.8371
71774250|NCT02567552|143048577|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71774251|NCT02567552|143048578|OTHER|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
71774252|NCT02567552|143048579|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
71832893|NCT02708108|143170032|OTHER|Multivariable analysis|Odds Ratio (OR)|0.3||||0.02|TWO_SIDED|95.0|0.09|0.92||Reported as 1-sided p-value.|Regression, Logistic||Multivariable model includes age, BMI category, cytogenetic risk, ethnicity, sex|||0.92|0.09|0.02
71832894|NCT01736215|143170040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.343||||0.266|TWO_SIDED|95.0|0.052|2.261||The binary logistic regression analysis was performed using a crude model between predictor variable endogenous EPO (EPO less than or equal to 45.2 and EPO greater than 45.3)|Regression, Logistic|||||2.261|0.052|0.266
71832895|NCT01736215|143170041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.125||||0.05|TWO_SIDED|95.0|0.016|0.999||The binary logistic regression analysis was performed using a crude model between predictor variable CRP (CRP less than or equal to 10.3 and CRP greater than 10.4)|Regression, Logistic|||||0.999|0.016|0.05
71832896|NCT00440011|143170088|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.024
71889954|NCT03575104|143301811|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-2.61||||0.3782|TWO_SIDED|95.0|-8.41|3.197||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00195; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||3.197|-8.41|0.3782
71774253|NCT03635788|143048581|SUPERIORITY|The study had approximately 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of regimen failure|Cumulative probability difference|-18.4|||||TWO_SIDED|98.4|-32.4|-4.3|||||Treatment difference was calculated as LA-ART minus SOC. 98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of regimen failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-4.3|-32.4|
71774254|NCT03635788|143048582|SUPERIORITY|The study had at least 80% power to show superiority of the LA ART compared to daily SOC with respect to the Step 2, week 48, cumulative probability of virologic failure|cumulative probability difference|-21.4|||||TWO_SIDED|98.4|-33.5|-9.3|||||Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of virologic failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||-9.3|-33.5|
71774255|NCT03635788|143048583|SUPERIORITY||cumulative probability diffeence|-19.2|||||TWO_SIDED|98.4|-31.6|-6.9||||||Treatment comparison was conducted by cumulative probability of treatment-related failure in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.|Treatment difference was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|-6.9|-31.6|
71774256|NCT03635788|143048584|SUPERIORITY|The proportions of participants with HIV-1 RNA ≥ 50 copies/ml was compared by Fisher's Exact Test.|Mean Difference (Final Values)|-21.8|||<|0.001|TWO_SIDED|95.0|-35.6|-8.1|||Fisher Exact||||Treatment difference in the proportions of participants with HIV-1 RNA ≥ 50 copies/ml was calculated as LA-ART minus SOC.|-8.1|-35.6|<0.001
71774257|NCT03635788|143048585|SUPERIORITY||Mean Difference (Final Values)|-24.5|||<|0.001|TWO_SIDED|95.0|-36.1|-12.8|||Fisher Exact||Difference in the proportions of participants with HIV-1 RNA ≥ 200 copies was calculated as LA-ART minus SOC.|The proportions of participants with HIV-1 RNA ≥ 200 copies/ml was compared by Fisher's Exact Test.||-12.8|-36.1|<0.001
71774258|NCT03635788|143048590|SUPERIORITY||Cumulative probability difference|-8.4|||||TWO_SIDED|98.4|-21.3|4.5|||||Treatment difference in cumulative of permanent treatment discontinuation was calculated as LA-ART minus SOC.98.4% is nominal confidence interval.|Treatment comparison was conducted by cumulative probability of permanent treatment discontinuation in Step 2 up to Step 2 Week 48 visit by treatment arm. The treatment difference was assessed using the 95% repeated confidence interval adjusted for interim efficacy analyses, i.e., a nominal 98.4% confidence interval.||4.5|-21.3|
71774259|NCT03811002|143048632|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.5819|TWO_SIDED|95.0|0.82|1.34|||Log Rank|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). 1-sided significance level 0.025.|Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|Assuming exponentially distributed survival times, 480 eligible patients accrued uniformly over 48 months months) with 26 months additional follow-up after the last accrued patient would provide at least 85% power to detect a hazard ratio of 0.71 (median survival times of 38 months \[Arm I\] vs. 27 months \[Arm II\]) at a one-sided significance level of 0.025, after adjusting for type 1 error using group sequential methods for two interim analyses.||1.34|0.82|0.5819
71774260|NCT03811002|143048633|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||Log Rank||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.21|0.80|
71774261|NCT03811002|143048636|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.52|1.41|||||Cause-specific hazard ratio stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm 1.|||1.41|0.52|
71774262|NCT03811002|143048637|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Stratified by radiation schedule (BID vs daily), chemotherapy (cisplatin vs carboplatin), and sex (male vs female). Reference level = Arm I.|||1.20|0.76|
71774263|NCT04191187|143048647|SUPERIORITY||PFS at 18 Months|70.8||||0.002|ONE_SIDED|90.0|59.2|||One sided log rank test|Log Rank||||||59.2|0.002
71775099|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.48|TWO_SIDED|95.0|-1.7|0.28||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.28|-1.70|0.48
71890240|NCT03952559|143302115|SUPERIORITY||Odds Ratio (OR)|1.42||||0.201|TWO_SIDED|95.0|0.83|2.41|||Regression, Logistic|||||2.41|0.83|0.2010
71890241|NCT03952559|143302115|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0017|TWO_SIDED|95.0|1.38|3.95|||Regression, Logistic|||||3.95|1.38|0.0017
71890242|NCT03952559|143302116|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8544|TWO_SIDED|95.0|0.43|2.01|||Regression, Logistic|||||2.01|0.43|0.8544
71890243|NCT03952559|143302116|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0561|TWO_SIDED|95.0|0.98|3.91|||Regression, Logistic|||||3.91|0.98|0.0561
71890244|NCT03952559|143302116|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0012|TWO_SIDED|95.0|1.54|5.82|||Regression, Logistic|||||5.82|1.54|0.0012
71774264|NCT02160782|143048653|EQUIVALENCE|The P-value for testing if the treatment group least squares (LS) means were equal was calculated to determine if the change in sBA levels between the treatment groups was statistically significant.|Mean Difference (Net)|-117.28|STANDARD_ERROR_OF_MEAN|52.828||0.0464|TWO_SIDED|95.0|-232.38|-2.18|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in fasting sBA levels was evaluated using an analysis of covariance (ANCOVA) model with treatment group as a factor, and Week 18 sBA as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the MITT population, which included all participants who were enrolled, received study drug through Week 18, and had a reduction from baseline in sBA of ≥50% at the Week 12 or Week 18 measurement.||-2.18|-232.38|0.0464
71774265|NCT02160782|143048654|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in sBA levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-87.73|STANDARD_DEVIATION|119.979||0.0005|TWO_SIDED|95.0|-133.37|-42.09||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in sBA levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||-42.09|-133.37|0.0005
71774266|NCT02160782|143048655|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Obs) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.704|STANDARD_DEVIATION|0.9114|<|0.0001|TWO_SIDED|95.0|-2.051|-1.357|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Obs) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.357|-2.051|< 0.0001
71774267|NCT02160782|143048656|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ItchRO(Pt) scores between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-2.072|STANDARD_DEVIATION|0.9931|<|0.0001|TWO_SIDED|95.0|-2.645|-1.498|||Student's t-test|||This analysis investigated whether a statistically significant change in ItchRO(Pt) score was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity.||-1.498|-2.645|< 0.0001
71774268|NCT02160782|143048657|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Obs) between the treatment groups was statistically significant.|Mean Difference (Net)|-1.483|STANDARD_ERROR_OF_MEAN|0.3103|<|0.0001|TWO_SIDED|95.0|-2.122|-0.844|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO(Obs) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Obs) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.844|-2.122|< 0.0001
71774269|NCT02160782|143048658|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ItchRO(Pt) between the treatment groups was statistically significant. While the number of participants included in analysis for the end point indicates 28, there were only 14; n = 5 for ItchRO(Pt): MRX and n = 9 for ItchRO(Pt): placebo.|Mean Difference (Net)|-1.988|STANDARD_ERROR_OF_MEAN|0.4641||0.0013|TWO_SIDED|95.0|-3.009|-0.967|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ItchRO (Pt) was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ItchRO(Pt) as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||-0.967|-3.009|0.0013
71774270|NCT02160782|143048659|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALP levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-27.8|STANDARD_DEVIATION|118.33||0.2163|TWO_SIDED|95.0|-72.8|17.2||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALP levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||17.2|-72.8|0.2163
71774271|NCT02160782|143048660|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALP levels between the treatment groups was statistically significant.|Mean Difference (Net)|10.0|STANDARD_ERROR_OF_MEAN|30.44||0.7455|TWO_SIDED|95.0|-52.6|72.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALP levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALP as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||72.6|-52.6|0.7455
71832897|NCT00419341|143170091|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of SCIG:IVIG treatment was concluded if the lower GMR confidence limit was 0.8 or more. With 18 evaluable subjects, the power to show this non-inferiority was calculated to be 85% based on the assumptions of an intra-individual variability with a coefficient of variation (CV) = 25% and a GMR equal to or greater than 1.|Geometric mean ratio (GMR)|1.002|||||TWO_SIDED|90.0|0.951|1.055||No P-value is provided as non-inferiority was assessed by the CI of the GMR.|t-test, 2 sided|Based on log-transformed individual differences.|Geometric mean ratio SCIG:IVIG non-inferiority was concluded if the lower GMR confidence limit was 0.8 or more|Individual sAUC values (standardized to a 7-day period) of the IV and adjusted SC sampling periods in each individual subject were log transformed and a parametric 2-sided 90% confidence interval (CI) for the mean of the individual differences was obtained. Back-transformation of the mean and its CI produced the geometric mean ratio (GMR) and its respective 90% CI.||1.055|0.951|
71832898|NCT02020252|143170109|SUPERIORITY|||||||0.307||||||This is for the receptivity sub-scale, and the comparison between pre and post-test scores.|t-test, 2 sided|This was a paired t-test.||||||.307
71774272|NCT02160782|143048661|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in ALT levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-1.3|STANDARD_DEVIATION|84.54||0.9358|TWO_SIDED|95.0|-33.4|30.9||Data for this analysis were obtained from 31 participants at baseline; 29 of those participants contributed Week 18 data.|Student's t-test|||This analysis investigated whether a statistically significant change in ALT levels was observed when comparing baseline to Week 18 (the open-label period, during which all participants received MRX). The analysis was based on the ITT population.||30.9|-33.4|0.9358
71660297|NCT05958888|142834918|SUPERIORITY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
71660298|NCT05958888|142834918|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.85||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
71774273|NCT02160782|143048662|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in ALT levels between the treatment groups was statistically significant.|Mean Difference (Net)|15.1|STANDARD_ERROR_OF_MEAN|19.53||0.4472|TWO_SIDED|95.0|-25.1|55.2|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||55.2|-25.1|0.4472
71774274|NCT02160782|143048663|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in total bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|1.424||0.0893|TWO_SIDED|95.0|-1.01|0.08|||Student's t-test|||||0.08|-1.01|0.0893
71736605|NCT03354273|142987772|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|22.0||||0.0195|TWO_SIDED|95.0|2.2|41.7|||McNemar|||Reader 2: Sensitivity||41.7|2.2|0.0195
71736606|NCT03354273|142987772|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.2|16.8|||Nam's RMLE|||Reader 2: Specificity||16.8|-3.2|0.0004
71832899|NCT02020252|143170109|SUPERIORITY|||||||0.009||||||This is for the willingness sub-scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.009
71774275|NCT02160782|143048664|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in total bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.361||0.7|TWO_SIDED|95.0|-0.88|0.6|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in total bilirubin was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 total bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.6|-0.88|0.7
71774276|NCT02160782|143048665|EQUIVALENCE|The null hypothesis that the mean change was equal to zero was tested using the Student's t-test to determine if the mean change in direct bilirubin levels between baseline and Week 18 (the open-label period) was statistically significant.|Mean Difference (Net)|-0.5|STANDARD_DEVIATION|1.012||0.0139|TWO_SIDED|95.0|-0.9|-0.11|||Student's t-test|||||-0.11|-0.9|0.0139
71774277|NCT02160782|143048666|EQUIVALENCE|The P-value for testing if the treatment group LS means were equal was calculated to determine if the change in direct bilirubin between the treatment groups was statistically significant.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.265||0.9517|TWO_SIDED|95.0|-0.56|0.53|||ANCOVA|||The difference between treatment groups in change from Week 18 to Week 22 in direct bilirubin levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 direct bilirubin as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.||0.53|-0.56|0.9517
71774278|NCT00674973|143048669|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1909|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).||1.10|0.63|0.1909
71774279|NCT00763048|143048674|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
71774280|NCT00763048|143048675|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
71774281|NCT00763048|143048676|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||<0.05
71774282|NCT00763048|143048677|SUPERIORITY_OR_OTHER|||||||0.05|ONE_SIDED|95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71774283|NCT00763048|143048678|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71774284|NCT00763048|143048679|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71774285|NCT00763048|143048680|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71774286|NCT00763048|143048681|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71889955|NCT03575104|143301812|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-9.01||||0.0053|TWO_SIDED|95.0|-15.339|-2.684||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00313; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||-2.684|-15.339|0.0053
71774287|NCT00763048|143048682|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.||||0.05
71774288|NCT00085709|143048703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Cox|The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.||Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.||||<0.001
71774289|NCT00085709|143048704|SUPERIORITY_OR_OTHER||||||<|0.0025||95.0|||||Test of difference of proportions|||Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.||||<0.0025
71774290|NCT02325791|143048753|SUPERIORITY||percentage treatment difference|1.15||||0.5773|TWO_SIDED|95.0|-2.898|5.201|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||5.201|-2.898|0.5773
71774291|NCT02325791|143048753|SUPERIORITY||percentage treatment difference|-0.44|||||TWO_SIDED|95.0|-4.318|3.438||Analysis performed using CMH statistics with randomization stratum adjusted using Mantel-Haenzel (MH) method to assess pairwise treatment difference (i.e. absolute risk reduction of each suptavumab arm compared to placebo.|Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each Suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.438|-4.318|
71774292|NCT02325791|143048757|SUPERIORITY||percentage treatment difference|-0.67|||||TWO_SIDED|95.0|-5.291|3.959|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||3.959|-5.291|
71660299|NCT05958888|142834919|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||.01
71660300|NCT05958888|142834919|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.23|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||.23
71736607|NCT03354273|142987772|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|17.1||||0.0174|TWO_SIDED|95.0|1.7|32.4|||McNemar|||Reader 3: Sensitivity||32.4|1.7|0.0174
71736608|NCT03354273|142987772|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|0.7||||0.024|TWO_SIDED|95.0|-9.9|11.3|||Nam's RMLE|||||11.3|-9.9|0.0240
71736609|NCT03354273|142987772|SUPERIORITY||Difference between PET MPI and SPECT MPI|17.1||||0.0448|TWO_SIDED|95.0|-1.5|35.6|||McNemar|||Majority Rule: Sensitivity||35.6|-1.5|0.0448
71736610|NCT03354273|142987772|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.8||||0.0004|TWO_SIDED|95.0|-3.4|17.0|||Nam's RMLE|||Majority Rule: Specificity||17.0|-3.4|0.0004
71736611|NCT03354273|142987773|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|12.0||||0.0116|TWO_SIDED|95.0|0.0|23.9|||McNemar|||Reader 1: Sensitivity||23.9|0.0|0.0116
71774293|NCT02325791|143048757|SUPERIORITY||percentage treatment difference|2.02|||||TWO_SIDED|95.0|-2.836|6.867|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) \& gestational age category (\<= 31 weeks 6 days GA vs \>= 32 weeks 0 days and \<= 35 weeks 6 days GA). Threshold for significance at 0.05 level.||6.867|-2.836|
71774294|NCT04010539|143048795|NON_INFERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.|Adjusted Difference in Percent|-0.1|||||TWO_SIDED|95.0|-5.6|5.5||||||||5.5|-5.6|
71832900|NCT02020252|143170109|SUPERIORITY||||||<|0.001||||||This is for knowledge sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|A paired t-test.||||||<.001
71660301|NCT05958888|142834919|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.01
71736612|NCT03354273|142987773|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|6.6||||0.0003|TWO_SIDED|95.0|-2.9|16.2|||Nam's RMLE|||Reader 1: Specificity||16.2|-2.9|0.0003
71736613|NCT03354273|142987773|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.8||||0.1085|TWO_SIDED|95.0|-5.2|18.9|||McNemar|||Reader 2: Sensitivity||18.9|-5.2|0.1085
71736614|NCT03354273|142987773|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.6|||<|0.0001|TWO_SIDED|95.0|2.1|21.1|||Nam's RMLE|||Reader 2: Specificity||21.1|2.1|<0.0001
71736615|NCT03354273|142987773|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|13.7||||0.0017|TWO_SIDED|95.0|3.8|23.5|||McNemar|||Reader 3: Sensitivity||23.5|3.8|0.0017
71736616|NCT03354273|142987773|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|2.8||||0.0034|TWO_SIDED|95.0|-6.6|12.1|||Nam's RMLE|||Reader 3: Specificity||12.1|-6.6|0.0034
71736617|NCT03354273|142987773|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|7.7||||0.0641|TWO_SIDED|95.0|-3.6|19.0|||McNemar|||Majority Rule: Sensitivity||19.0|-3.6|0.0641
71736618|NCT03354273|142987773|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|5.0||||0.001|TWO_SIDED|95.0|-4.6|14.6|||Nam's RMLE|||Majority Rule: Specificity||14.6|-4.6|0.0010
71736619|NCT03354273|142987774|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|11.0||||0.0294|TWO_SIDED|95.0|-2.6|24.6|||McNemar|||Reader 1: Sensitivity||24.6|-2.6|0.0294
71832901|NCT02020252|143170109|SUPERIORITY|||||||0.004||||||This is for the positive attitudes sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||.004
71660302|NCT05958888|142834919|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.58
71660303|NCT05958888|142834919|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.85|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.85
71774295|NCT04010539|143048795|SUPERIORITY|The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Superiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above 0.0%.|Adjusted Difference in Percent|-0.1||||0.5072|TWO_SIDED|95.0|-5.6|5.5|||1-sided p-value for Test of Superiority|||||5.5|-5.6|0.5072
71774296|NCT04795622|143048851|SUPERIORITY||Odds Ratio (OR)|1.3545|||||TWO_SIDED|95.0|0.753|2.4365||||||||2.4365|0.7530|
71890245|NCT03952559|143302117|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.349||0.2627|TWO_SIDED|95.0|-4.16|1.14|||Mixed Models Analysis|||||1.14|-4.16|0.2627
71660304|NCT05958888|142834919|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.58|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.58
71736620|NCT03354273|142987774|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|3.9||||0.0117|TWO_SIDED|95.0|-8.3|16.1|||Nam's RMLE|||Reader 1: Specificity||16.1|-8.3|0.0117
71736621|NCT03354273|142987774|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|6.6||||0.1444|TWO_SIDED|95.0|-7.1|20.3|||McNemar|||Reader 2: Sensitivity||20.3|-7.1|0.1444
71736622|NCT03354273|142987774|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|11.7||||0.0001|TWO_SIDED|95.0|-0.4|23.7|||Nam's RMLE|||Reader 2: Specificity||23.7|-0.4|0.0001
71736623|NCT03354273|142987774|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|8.8||||0.044|TWO_SIDED|95.0|-1.3|18.9|||McNemar|||Reader 3: Sensitivity||18.9|-1.3|0.0440
71736624|NCT03354273|142987774|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|7.8||||0.0022|TWO_SIDED|95.0|-4.8|20.3|||Nam's RMLE|||Reader 3: Specificity||20.3|-4.8|0.0022
71736625|NCT03354273|142987774|SUPERIORITY|The test of sensitivity comparison between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a 1-sided McNemar's test at a significance level of 0.025 using 1-sided McNemar's tests.|Difference between PET MPI and SPECT MPI|4.4||||0.2164|TWO_SIDED|95.0|-8.4|17.2|||McNemar|||Majority Rule: Sensitivity||17.2|-8.4|0.2164
71736626|NCT03354273|142987774|NON_INFERIORITY|The test of specificity noninferiority between Flurpiridaz (18F) Injection PET MPI and SPECT MPI was performed with a paired test for noninferiority at a 1-sided significance level of 0.025 using Nam's RMLE method (margin=0.1).|Difference between PET MPI and SPECT MPI|9.7||||0.0006|TWO_SIDED|95.0|-2.6|22.0|||Nam's RMLE|||Majority Rule: Specificity||22.0|-2.6|0.0006
71736627|NCT00741013|142987796|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Only a single statistical analysis was performed upon completion of the study.|ANOVA|||One-way analysis of variance was performed to determine whether lovastatin or rhAPC effectively reduced endotoxin-induced lung inflammation.||||<0.05
71736628|NCT00921843|142987808|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71736629|NCT02870101|142987809|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|94.7|||||TWO_SIDED|95.0|90.7|97.0|||||PPA estimated with two-sided 95% score confidence interval.|||97.0|90.7|
71736630|NCT02870101|142987809|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
71736631|NCT02870101|142987810|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|91.2|||||TWO_SIDED|95.0|86.5|94.4|||||PPA estimated with two-sided 95% score confidence interval.|||94.4|86.5|
71736632|NCT02870101|142987810|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.3|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.3|
71736633|NCT02870101|142987811|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|95.1|||||TWO_SIDED|95.0|91.3|97.3|||||PPA estimated with two-sided 95% score confidence interval.|||97.3|91.3|
71774297|NCT04795622|143048852|SUPERIORITY||Point Estimate|-0.0856|||||TWO_SIDED|95.0|-0.2395|0.0683||||||X-axis||0.0683|-0.2395|
71774298|NCT04795622|143048852|SUPERIORITY||Point Estimate|-0.033|||||TWO_SIDED|95.0|-0.2268|0.1608||||||Y-axis||0.1608|-0.2268|
71774299|NCT04795622|143048852|SUPERIORITY||Point Estimate|0.1791|||||TWO_SIDED|95.0|-0.1551|0.5133||||||Z-axis||0.5133|-0.1551|
71660305|NCT05958888|142834920|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||>.99
71660306|NCT05958888|142834920|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||>.99
71660307|NCT05958888|142834920|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.47|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||.47
71660308|NCT05958888|142834920|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1|>|0.99|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||>.99
71660309|NCT05958888|142834920|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.45|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.45
71660310|NCT05958888|142834920|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.7|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.70
71660311|NCT05958888|142834921|SUPERIORITY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71660312|NCT05958888|142834921|SUPERIORITY||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71660313|NCT05958888|142834921|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71774300|NCT00089674|143048857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.0001||95.0|6.2|7.1|||ANCOVA|||||7.1|6.2|<0.0001
71890246|NCT03952559|143302117|SUPERIORITY||LS Mean difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|1.342||0.2135|TWO_SIDED|95.0|-4.31|0.97|||Mixed Models Analysis|||||0.97|-4.31|0.2135
71890247|NCT03952559|143302117|SUPERIORITY||LS Mean difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.347||0.0443|TWO_SIDED|95.0|-5.36|-0.07|||Mixed Models Analysis|||||-0.07|-5.36|0.0443
71660314|NCT05958888|142834921|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
71660315|NCT05958888|142834921|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||<.001
71660316|NCT05958888|142834921|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.72|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.72
71660317|NCT05958888|142834922|SUPERIORITY||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71660318|NCT05958888|142834922|SUPERIORITY||Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71660319|NCT05958888|142834922|SUPERIORITY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71774301|NCT00089674|143048858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||<|0.0001||95.0|3.5|4.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||4.4|3.5|<0.0001
71774302|NCT00089674|143048859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|||<|0.0001||95.0|4.4|5.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.1|4.4|<0.0001
71774303|NCT00089674|143048860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|7.4|8.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||8.4|7.4|<0.0001
71774304|NCT00089674|143048861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|||<|0.0001||95.0|4.4|5.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||5.4|4.4|<0.0001
71774305|NCT00089674|143048862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|||<|0.0001||95.0|5.4|6.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA|||||6.1|5.4|<0.0001
71889956|NCT03575104|143301812|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-3.19||||0.3233|TWO_SIDED|95.0|-9.528|3.146||Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||3.146|-9.528|0.3233
71889957|NCT03575104|143301813|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|16.13|||<|0.0001|TWO_SIDED|95.0|8.224|24.035||Hypothesis testing result: threshold for significance p = 0.0125; statistically significant = YES|Mixed Models Analysis|||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).||24.035|8.224|<.0001
71889958|NCT03575104|143301813|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.37|||=|0.0009|TWO_SIDED|95.0|5.507|21.226||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 10 mg vs placebo).||21.226|5.507|= 0.0009
71736634|NCT02870101|142987811|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||TWO_SIDED|95.0|98.3|99.2|||||NPA estimated with two-sided 95% score confidence interval.|||99.2|98.3|
71774306|NCT00089674|143048863|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.1048||95.0|0.46|1.08||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.08|0.46|0.1048
71660320|NCT05958888|142834922|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||<.001
71736635|NCT02870101|142987812|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|96.5|||||TWO_SIDED|95.0|92.9|98.3|||||PPA estimated with two-sided 95% score confidence interval.|||98.3|92.9|
71736636|NCT02870101|142987812|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.2|||||TWO_SIDED|95.0|98.8|99.5|||||NPA estimated with two-sided 95% score confidence interval.|||99.5|98.8|
71774307|NCT00089674|143048864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0125||95.0|0.18|0.78||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||0.78|0.18|0.0125
71736637|NCT02870101|142987813|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|84.8|||||TWO_SIDED|95.0|79.4|89.0|||||PPA estimated with two-sided 95% score confidence interval.|||89.0|79.4|
71736638|NCT02870101|142987813|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.5|||||TWO_SIDED|95.0|99.2|99.7|||||NPA estimated with two-sided 95% score confidence interval.|||99.7|99.2|
71736639|NCT02870101|142987814|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|88.3|||||TWO_SIDED|95.0|83.2|92.0|||||PPA estimated with two-sided 95% score confidence interval.|||92.0|83.2|
71736640|NCT02870101|142987814|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||TWO_SIDED|95.0|99.2|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.2|
71736641|NCT02870101|142987815|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|95.9|||||TWO_SIDED|95.0|86.3|98.9|||||PPA estimated with two-sided 95% score confidence interval.|||98.9|86.3|
71736642|NCT02870101|142987815|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
71774308|NCT00089674|143048865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.7961||95.0|0.57|1.55||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Cox|||||1.55|0.57|0.7961
71774309|NCT00089674|143048866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.7961||95.0|0.44|1.11||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic|||||1.11|0.44|0.7961
71774310|NCT00667602|143048876|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage Difference|-8.0|||||TWO_SIDED|95.0|-15.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .||-1|-15|
71890248|NCT03952559|143302118|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4943|TWO_SIDED|95.0|0.3|1.78|||Regression, Logistic|||||1.78|0.30|0.4943
71736643|NCT02870101|142987816|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|86.0|||||TWO_SIDED|95.0|80.9|89.9|||||PPA estimated with two-sided 95% score confidence interval.|||89.9|80.9|
71736644|NCT02870101|142987816|OTHER|Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.3|||||TWO_SIDED|95.0|98.9|99.6|||||NPA estimated with two-sided 95% score confidence interval.|||99.6|98.9|
71736645|NCT02870101|142987817|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.2|||||TWO_SIDED|95.0|76.6|94.5|||||PPA estimated with two-sided 95% score confidence interval.|||94.5|76.6|
71736646|NCT02870101|142987817|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||TWO_SIDED|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.|||99.8|99.4|
71736647|NCT02870101|142987818|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.7|||||TWO_SIDED|95.0|83.9|92.3|||||PPA estimated with two-sided 95% score confidence interval.|||92.3|83.9|
71736648|NCT02870101|142987818|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.7|||||TWO_SIDED|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.|||99.1|98.2|
71736649|NCT02870101|142987819|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|84.0|||||TWO_SIDED|95.0|71.5|91.7|||||PPA estimated with two-sided 95% score confidence interval.|||91.7|71.5|
71736650|NCT02870101|142987819|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.8|||||TWO_SIDED|95.0|99.5|99.9|||||NPA estimated with two-sided 95% score confidence interval.|||99.9|99.5|
71736651|NCT02870101|142987820|OTHER|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|83.0|||||TWO_SIDED|95.0|77.6|87.3|||||PPA estimated with two-sided 95% score confidence interval.|||87.3|77.6|
71736652|NCT02870101|142987820|OTHER|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.1|||||TWO_SIDED|95.0|98.6|99.4|||||NPA estimated with two-sided 95% score confidence interval.|||99.4|98.6|
71890249|NCT03952559|143302118|SUPERIORITY||Odds Ratio (OR)|1.72||||0.1677|TWO_SIDED|95.0|0.8|3.7|||Regression, Logistic|||||3.70|0.80|0.1677
71660321|NCT05958888|142834922|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.14||0.01|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.01
71660322|NCT05958888|142834922|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.04
71660323|NCT05958888|142834923|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Text vs. Control||||<.001
71660324|NCT05958888|142834923|SUPERIORITY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Control||||<.001
71736653|NCT00774800|142987829|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.54||||0.0011||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0011
71736654|NCT00774800|142987829|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|3.06|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
71736655|NCT00774800|142987830|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.35||||0.0057||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0057
71736656|NCT00774800|142987830|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|1.66|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
71660325|NCT05958888|142834923|SUPERIORITY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Control||||<.001
71660326|NCT05958888|142834923|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.15||0.43|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Icon vs. Text||||.43
71660327|NCT05958888|142834923|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Text||||.81
71660328|NCT05958888|142834923|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.81|TWO_SIDED|||||p-values were adjusted for multiple comparisons using the Bonferroni-Holm method, correcting for six tests within each outcome. The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|||Graphic vs. Icon||||.81
71736657|NCT00774800|142987831|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-18.33|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||<0.0001
71736658|NCT00774800|142987831|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-62.46||||0.0018|||||||ANOVA|Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.||||0.0018
71736659|NCT01059994|142987833|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71736660|NCT01059994|142987834|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||||||0.004
71736661|NCT00479856|142987842|SUPERIORITY_OR_OTHER||percentage of participants|33.3||||||95.0|7.5|70.1||||||||70.1|7.5|
71736662|NCT00098306|142987867|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|STANDARD_ERROR_OF_MEAN|0.1571|||TWO_SIDED|97.5|-1.141|-0.435||||||The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.435|-1.141|
71736663|NCT00098306|142987867|SUPERIORITY_OR_OTHER||LS mean difference|-0.922|STANDARD_ERROR_OF_MEAN|0.1568|||TWO_SIDED|97.5|-1.275|-0.57||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.570|-1.275|
71736664|NCT00098306|142987868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88|||<|0.0001|TWO_SIDED|95.0|1.78|4.67|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \[\<\] 100,000 or greater than or equal to \[\>=\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\>) 1 favors maraviroc.||4.67|1.78|<0.0001
71832902|NCT02020252|143170109|SUPERIORITY||||||<|0.001||||||This was for the self-efficacy sub scale, and the comparison between pre and posttest scores.|t-test, 2 sided|This was a paired t-test.||||||<.001
71832903|NCT06336629|143170238|SUPERIORITY||two-sided|100.0|||||TWO_SIDED|95.0||||||||||||
71832904|NCT06336629|143170239|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71832905|NCT06336629|143170240|SUPERIORITY|||||||0.007|||||||Wilcoxon rank-sum test|||||||0.007
71832906|NCT06336629|143170241|SUPERIORITY|||||||0.009|||||||Wilcoxon rank sum test|||||||0.009
71660329|NCT03244644|142834929|SUPERIORITY||Treatment Difference|13.1|||||TWO_SIDED|95.0|2.3|24.0|||||The Bayesian posterior probability of superiority was 0.99136. This value exceeded the pre-specified threshold of 0.9750338 (nominal 0.025 one-sided level).|A hierarchical, closed-testing procedure (Bayesian hierarchical model) was utilized for the primary endpoint. The Bayesian hierarchical model formally incorporated data from the previous Phase 2B study (NCT02299570) of RBX2660. This analysis tested the hypothesis that the response rate of RBX2660 was superior to Placebo and was performed at the nominal 0.00125 and 0.025 one-sided levels.||24.0|2.3|
71660330|NCT03244644|142834930|SUPERIORITY|||||||0.156||||||P-value for secondary outcome evaluated from baseline through 6 months|Chi-squared|||||||0.156
71660331|NCT00642694|142834962|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71660332|NCT03688282|142834971|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71660333|NCT01007942|142834990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0067|TWO_SIDED|95.0|0.65|0.95|||Log Rank|||||0.95|0.65|0.0067
71736665|NCT00098306|142987868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.66|||<|0.0001|TWO_SIDED|95.0|2.26|5.95|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.95|2.26|<0.0001
71736666|NCT00098306|142987868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.96|||<|0.0001|TWO_SIDED|95.0|2.36|6.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.64|2.36|<0.0001
71736667|NCT00098306|142987868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.11|||<|0.0001|TWO_SIDED|95.0|3.04|8.59|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.59|3.04|<0.0001
71660334|NCT04040322|142835041|SUPERIORITY||Least squares mean difference in change|-1.26||||0.421|TWO_SIDED|95.0|-4.34|1.82||Threshold for statistical significance was p \< 0.05|ANCOVA|||||1.82|-4.34|0.4210
71660335|NCT03056157|142835045|SUPERIORITY||Slope|-0.236||||0.03|TWO_SIDED|95.0|-3.34|-0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1519 )= -2.19, d = 0.15.||-0.18|-3.34|0.03
71660336|NCT03056157|142835045|SUPERIORITY||Slope|-8.97|||<|0.001|TWO_SIDED|95.0|-10.12|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to- treat data for SDS scores, t(160)= -15.74, d = 2.97.||-6.11|-10.12|<.001
71736668|NCT00098306|142987869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.63|4.13|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.13|1.63|<0.0001
71660337|NCT03056157|142835045|SUPERIORITY||Slope|-6.62|||<|0.001|TWO_SIDED|95.0|-8.35|-6.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(160) = -12.72, d = 1.86.||-6.11|-8.35|<0.001
71774311|NCT00667602|143048877|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage difference|-7.0|||||TWO_SIDED|95.0|-13.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.||-2|-13|
71660338|NCT03056157|142835045|SUPERIORITY||Slope|-0.65||||0.49|TWO_SIDED|95.0|-2.13|0.86|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = -0.90, d = 0.05.||0.86|-2.13|0.49
71832907|NCT06336629|143170242|SUPERIORITY|||||||0.037||||||P-value from Baseline at Week 16|Wilcoxon signed rank|P-value from Baseline at Week 16||||||0.037
71660339|NCT03056157|142835045|SUPERIORITY||Slope|1.1|||<|0.001|TWO_SIDED|95.0|0.06|2.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 2.11, d = 0.11.||2.17|0.06|<0.001
71660340|NCT03056157|142835045|SUPERIORITY||Slope|1.75|||<|0.001|TWO_SIDED|95.0|0.75|2.81|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores, t(1510) = 3.45, d = 0.18||2.81|0.75|<0.001
71736669|NCT00098306|142987869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|1.79|4.54|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.54|1.79|<0.0001
71736670|NCT00098306|142987869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001|TWO_SIDED|95.0|1.83|4.67|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.67|1.83|<0.0001
71736671|NCT00098306|142987869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.08|5.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.32|2.08|<0.0001
71736672|NCT00098306|142987870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|1.92|4.88|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.88|1.92|<0.0001
71774312|NCT00667602|143048878|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|72.0|||||TWO_SIDED|95.0|64.0|79.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||79|64|
71774313|NCT00667602|143048878|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Net)|7.0|||||TWO_SIDED|95.0|3.0|13.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||13|3|
71774314|NCT00667602|143048878|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|80.0|||||TWO_SIDED|95.0|73.0|86.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||86|73|
71774315|NCT00667602|143048878|NON_INFERIORITY_OR_EQUIVALENCE|(PMenACWY - PMenC \> -10%).|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.0|5.0|||Percentage difference|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than -10%.||5|-2|
71774316|NCT00667602|143048880|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.12|0.76|
71774317|NCT00667602|143048880|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenC \> 0.5).|Ratio|0.73|||||TWO_SIDED|95.0|0.57|0.93|||ANOVA|||For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||0.93|0.57|
71774318|NCT00667602|143048882|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|10.0|||||TWO_SIDED|95.0|8.43|13.0|||ANOVA|||For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .||13|8.43|
71774319|NCT00667602|143048882|NON_INFERIORITY_OR_EQUIVALENCE|(GMTMenACWY/GMTMenjugate \> 0.5).|Ratio|8.1|||||TWO_SIDED|95.0|6.35|10.0|||ANOVA|||For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.||10|6.35|
71774320|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71890250|NCT03952559|143302118|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0336|TWO_SIDED|95.0|1.06|4.7|||Regression, Logistic|||||4.70|1.06|0.0336
71774321|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71774322|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||5|-3|
71774323|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-3|
71832908|NCT06336629|143170244|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
71832909|NCT06336629|143170245|SUPERIORITY|||||||1||||||P-value from Baseline at Week 16|Wilcoxon signed rank|||||||1
71774324|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71774325|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71774326|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-2.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
71774327|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-6|
71774328|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
71774329|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
71774330|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
71774331|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-3|
71774332|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
71832910|NCT04043455|143170254|SUPERIORITY||Least square mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.407|=|0.65|TWO_SIDED|95.0|-0.99|0.62|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% confidence interval (CI) has been presented.||0.62|-0.99|=0.650
71736673|NCT00098306|142987870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.22|5.68|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.68|2.22|<0.0001
71736674|NCT00098306|142987870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.05|5.31|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.31|2.05|<0.0001
71736675|NCT00098306|142987870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.03|||<|0.0001|TWO_SIDED|95.0|2.5|6.51|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||6.51|2.50|<0.0001
71736676|NCT00098306|142987871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.0006|TWO_SIDED|95.0|1.46|4.04|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||4.04|1.46|0.0006
71736677|NCT00098306|142987871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.15|||<|0.0001|TWO_SIDED|95.0|1.9|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||5.23|1.90|<0.0001
71774333|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|3.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-2|
71774334|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71774335|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-2|
71832911|NCT04043455|143170254|SUPERIORITY||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.409|=|0.439|TWO_SIDED|95.0|-1.12|0.49|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.49|-1.12|=0.439
71890251|NCT03952559|143302119|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8866|TWO_SIDED|95.0|0.42|2.77|||Regression, Logistic|||||2.77|0.42|0.8866
71736678|NCT00098306|142987871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|95.0|2.32|7.25|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||7.25|2.32|<0.0001
71736679|NCT00098306|142987871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.0001|TWO_SIDED|95.0|2.82|8.77|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\<100,000 or \>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \>1 favors maraviroc.||8.77|2.82|<0.0001
71736680|NCT00098306|142987873|SUPERIORITY_OR_OTHER||LS mean difference|54.49|STANDARD_ERROR_OF_MEAN|12.435|||TWO_SIDED|95.0|30.07|78.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||78.92|30.07|
71736681|NCT00098306|142987873|SUPERIORITY_OR_OTHER||LS mean difference|58.94|STANDARD_ERROR_OF_MEAN|12.378|||TWO_SIDED|95.0|34.63|83.26||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.26|34.63|
71736682|NCT00098306|142987873|SUPERIORITY_OR_OTHER||LS mean difference|58.56|STANDARD_ERROR_OF_MEAN|12.677|||TWO_SIDED|95.0|33.66|83.46||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||83.46|33.66|
71736683|NCT00098306|142987873|SUPERIORITY_OR_OTHER||LS mean difference|68.47|STANDARD_ERROR_OF_MEAN|12.617|||TWO_SIDED|95.0|43.69|93.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||93.25|43.69|
71890252|NCT03952559|143302119|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2316|TWO_SIDED|95.0|0.7|4.26|||Regression, Logistic|||||4.26|0.70|0.2316
71890253|NCT03952559|143302119|SUPERIORITY||Odds Ratio, log|2.59||||0.0328|TWO_SIDED|95.0|1.08|6.22|||Regression, Logistic|||||6.22|1.08|0.0328
71736684|NCT00098306|142987874|SUPERIORITY_OR_OTHER||LS mean difference|284.21|STANDARD_ERROR_OF_MEAN|51.779|||TWO_SIDED|95.0|182.51|385.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||385.92|182.51|
71736685|NCT00098306|142987874|SUPERIORITY_OR_OTHER||LS mean difference|303.07|STANDARD_ERROR_OF_MEAN|51.507|||TWO_SIDED|95.0|201.9|404.23||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||404.23|201.90|
71736686|NCT00098306|142987874|SUPERIORITY_OR_OTHER||LS mean difference|213.34|STANDARD_ERROR_OF_MEAN|49.679|||TWO_SIDED|95.0|115.77|310.92||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||310.92|115.77|
71736687|NCT00098306|142987874|SUPERIORITY_OR_OTHER||LS mean difference|235.74|STANDARD_ERROR_OF_MEAN|49.416|||TWO_SIDED|95.0|138.68|332.8||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.||332.80|138.68|
71832912|NCT04043455|143170254|SUPERIORITY||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.401|=|0.172|TWO_SIDED|95.0|-1.34|0.24|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.24|-1.34|=0.172
71890254|NCT03952559|143302120|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5361|TWO_SIDED|95.0|0.7|1.98|||Regression, Logistic|||||1.98|0.70|0.5361
71890255|NCT03952559|143302120|SUPERIORITY||Odds Ratio (OR)|1.23||||0.4417|TWO_SIDED|95.0|0.73|2.06|||Regression, Logistic|||||2.06|0.73|0.4417
71890256|NCT03952559|143302120|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0121|TWO_SIDED|95.0|1.16|3.43|||Regression, Logistic|||||3.43|1.16|0.0121
71890257|NCT03952559|143302121|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7706|TWO_SIDED|95.0|0.37|3.78|||Regression, Logistic|||||3.78|0.37|0.7706
71736688|NCT00098306|142987875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.34|0.6|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.60|0.34|<0.0001
71736689|NCT00098306|142987875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.28|0.5|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \<1 favors maraviroc.||0.50|0.28|<0.0001
71736690|NCT00098306|142987876|SUPERIORITY_OR_OTHER||LS mean difference|-0.697|STANDARD_ERROR_OF_MEAN|0.1347|||TWO_SIDED|95.0|-0.961|-0.432||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.432|-0.961|
71736691|NCT00098306|142987876|SUPERIORITY_OR_OTHER||LS mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|95.0|-1.065|-0.538||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.538|-1.065|
71736692|NCT00098306|142987876|SUPERIORITY_OR_OTHER||LS mean difference|-0.767|STANDARD_ERROR_OF_MEAN|0.1497|||TWO_SIDED|95.0|-1.061|-0.474||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.474|-1.061|
71736693|NCT00098306|142987876|SUPERIORITY_OR_OTHER||LS mean difference|-0.931|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-1.225|-0.638||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.||-0.638|-1.225|
71736694|NCT00098306|142987877|SUPERIORITY_OR_OTHER||LS mean difference|-0.853|STANDARD_ERROR_OF_MEAN|0.1621|||TWO_SIDED|97.5|-1.217|-0.489||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.489|-1.217|
71832913|NCT04043455|143170261|SUPERIORITY||Odds Ratio (OR)|1.156||||0.659|TWO_SIDED|95.0|-0.019|2.331|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odds ratio and 95% CI has been presented.||2.331|-0.019|0.659
71832914|NCT04043455|143170261|SUPERIORITY||Odds Ratio (OR)|1.248||||0.557|TWO_SIDED|95.0|-0.04|2.535|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odds ratio and 95% CI has been presented.||2.535|-0.040|0.557
71832915|NCT04043455|143170261|SUPERIORITY||Odds Ratio (OR)|1.245||||0.541|TWO_SIDED|95.0|0.027|2.462|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odds ratio and 95% CI has been presented.||2.462|0.027|0.541
71832916|NCT04043455|143170262|SUPERIORITY||Odds Ratio (OR)|1.234||||0.529|TWO_SIDED|95.0|-0.001|2.468|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 10 mg and placebo using Odd's ratio and 95% CI has been presented.||2.468|-0.001|0.529
71832917|NCT04043455|143170262|SUPERIORITY||Odds Ratio (OR)|1.123||||0.73|TWO_SIDED|95.0|0.015|2.232|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 25 mg and placebo using Odd's ratio and 95% CI has been presented.||2.232|0.015|0.730
71832918|NCT04043455|143170262|SUPERIORITY||Odds Ratio (OR)|1.226||||0.548|TWO_SIDED|95.0|0.025|2.428|||Cochran-Mantel-Haenszel|||Treatment comparison between Olorinab 50 mg and placebo using Odd's ratio and 95% CI has been presented.||2.428|0.025|0.548
71832919|NCT04043455|143170263|SUPERIORITY||Least square mean difference|-2.42|STANDARD_ERROR_OF_MEAN|6.189||0.696|TWO_SIDED|95.0|-14.61|9.76|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||9.76|-14.61|0.696
71832920|NCT04043455|143170263|SUPERIORITY||Least square mean difference|-3.25|STANDARD_ERROR_OF_MEAN|6.222||0.602|TWO_SIDED|95.0|-15.51|9.0|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||9.00|-15.51|0.602
71890258|NCT03952559|143302121|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7409|TWO_SIDED|95.0|0.38|3.86|||Regression, Logistic|||||3.86|0.38|0.7409
71832921|NCT04043455|143170263|SUPERIORITY||Least square mean difference|-3.96|STANDARD_ERROR_OF_MEAN|6.088||0.516|TWO_SIDED|95.0|-15.95|8.03|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||8.03|-15.95|0.516
71736695|NCT00098306|142987877|SUPERIORITY_OR_OTHER||LS mean difference|-1.021|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|97.5|-1.385|-0.658||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.||-0.658|-1.385|
71736696|NCT01336023|142987896|NON_INFERIORITY|"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.~IDegLira minus IDeg"|Treatment Contrast|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36|||ANCOVA||IDegLira minus IDeg|||-0.36|-0.58|
71890259|NCT03952559|143302121|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0253|TWO_SIDED|95.0|1.15|8.63|||Regression, Logistic|||||8.63|1.15|0.0253
71890260|NCT03952559|143302122|SUPERIORITY||LS Mean difference (Final Values)|-3.89|STANDARD_ERROR_OF_MEAN|2.576||0.1317|TWO_SIDED|95.0|-8.95|1.17|||Mixed Models Analysis|||||1.17|-8.95|0.1317
71736697|NCT01336023|142987896|SUPERIORITY|"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.~IDegLira minus Liraglutide"|Treatment contrast|-0.64|||||TWO_SIDED|95.0|-0.75|-0.53|||ANCOVA||IDegLira minus Liraglutide|||-0.53|-0.75|
71890261|NCT03952559|143302122|SUPERIORITY||LS Mean difference (Final Values)|-5.15|STANDARD_ERROR_OF_MEAN|2.564||0.0451|TWO_SIDED|95.0|-10.19|-0.11|||Mixed Models Analysis|||||-0.11|-10.19|0.0451
71890262|NCT03952559|143302122|SUPERIORITY||LS Mean difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.566||0.0031|TWO_SIDED|95.0|-12.66|-2.58|||Mixed Models Analysis|||||-2.58|-12.66|0.0031
71890263|NCT03952559|143302123|SUPERIORITY||Odds Ratio (OR)|0.53||||0.4238|TWO_SIDED|95.0|0.11|2.49|||Regression, Logistic|||||2.49|0.11|0.4238
71736698|NCT01122849|142987905|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|-0.12||||0.5456|TWO_SIDED|95.0|-0.52|0.28||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.28|-0.52|0.5456
71736699|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS mean difference|-0.34||||0.1029|TWO_SIDED|95.0|-0.75|0.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.07|-0.75|0.1029
71736700|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS mean difference|0.22||||0.2879|TWO_SIDED|95.0|-0.19|0.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7||0.62|-0.19|0.2879
71736701|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8213|TWO_SIDED|95.0|-0.45|0.56||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.56|-0.45|0.8213
71736702|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24||||0.3457||95.0|-0.74|0.27||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7||0.27|-0.74|0.3457
71736703|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2364|TWO_SIDED|95.0|-0.2|0.79|||ANCOVA|||Comparison for Q3 at Day 7||0.79|-0.20|0.2364
71736704|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.3553|TWO_SIDED|95.0|-0.21|0.57||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.57|-0.21|0.3553
71736705|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.3369|TWO_SIDED|95.0|-0.58|0.2||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.20|-0.58|0.3369
71736706|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.0591|TWO_SIDED|95.0|-0.01|0.76||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7||0.76|-0.01|0.0591
71832922|NCT04043455|143170264|SUPERIORITY||Least square mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.305||0.804|TWO_SIDED|95.0|-0.53|0.68|||Mixed Models Analysis|||Treatment comparison between Olorinab 10 mg and placebo using least square mean difference and 95% CI has been presented.||0.68|-0.53|0.804
71832923|NCT04043455|143170264|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.308||0.618|TWO_SIDED|95.0|-0.76|0.45|||Mixed Models Analysis|||Treatment comparison between Olorinab 25 mg and placebo using least square mean difference and 95% CI has been presented.||0.45|-0.76|0.618
71832924|NCT04043455|143170264|SUPERIORITY||Least square mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.301||0.687|TWO_SIDED|95.0|-0.47|0.71|||Mixed Models Analysis|||Treatment comparison between Olorinab 50 mg and placebo using least square mean difference and 95% CI has been presented.||0.71|-0.47|0.687
71736707|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.7686|TWO_SIDED|95.0|-0.42|0.31||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q18 at Day 7||0.31|-0.42|0.7686
71736708|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46||||0.0151|TWO_SIDED|95.0|-0.83|-0.09|||ANCOVA|||Comparison of Q18 at Day 7||-0.09|-0.83|0.0151
71736709|NCT01122849|142987905|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0256|TWO_SIDED|95.0|0.05|0.77||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 7||0.77|0.05|0.0256
71736710|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.5958|TWO_SIDED|95.0|-0.52|0.3||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1at Day 14||0.30|-0.52|0.5958
71736711|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1429|TWO_SIDED|95.0|-0.73|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 14||0.11|-0.73|0.1429
71774336|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0||Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.|Miettinen and Nurminen|||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-2|
71774337|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||2|-4|
71774338|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
71890264|NCT03952559|143302123|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5118|TWO_SIDED|95.0|0.44|5.08|||Regression, Logistic|||||5.08|0.44|0.5118
71890265|NCT03952559|143302123|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0129|TWO_SIDED|95.0|1.34|11.52|||Regression, Logistic|||||11.52|1.34|0.0129
71736712|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.3348|TWO_SIDED|95.0|-0.21|0.62|||ANCOVA|||Comparison of Q1 at Day 14||0.62|-0.21|0.3348
71736713|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.4425||95.0|-0.32|0.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.72|-0.32|0.4425
71736714|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.4795|TWO_SIDED|95.0|-0.71|0.34|||ANCOVA|||Comparison of Q3 at Day 14||0.34|-0.71|0.4795
71736715|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39||||0.1375|TWO_SIDED|95.0|-0.13|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14||0.90|-0.13|0.1375
71736716|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.575|TWO_SIDED|95.0|-0.56|0.31||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.31|-0.56|0.5750
71736717|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.0337|TWO_SIDED|95.0|-0.92|-0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||-0.04|-0.92|0.0337
71736718|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1061|TWO_SIDED|95.0|-0.08|0.79||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14||0.79|-0.08|0.1061
71736719|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.7092|TWO_SIDED|95.0|-0.5|0.34||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 14||0.34|-0.50|0.7092
71736720|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49||||0.025|TWO_SIDED|95.0|-0.91|-0.06||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day14||-0.06|-0.91|0.0250
71736721|NCT01122849|142987906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.0503|TWO_SIDED|95.0|0.0|0.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q18 at Day 14||0.82|0.00|0.0503
71736722|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.5462|TWO_SIDED|95.0|-1.92|3.59||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 7||3.59|-1.92|0.5462
71736723|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.37||||0.0942|TWO_SIDED|95.0|-5.16|0.42||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for sleep problems at Day 7||0.42|-5.16|0.0942
71736724|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.0221|TWO_SIDED|95.0|0.48|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep problems at Day 7||5.93|0.48|0.0221
71736725|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean difference|-0.72||||0.6731|TWO_SIDED|95.0|-4.11|2.68||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Sleep Time problems at Day 7||2.68|-4.11|0.6731
71736726|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.57||||0.1354|TWO_SIDED|95.0|-5.98|0.83||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Sleep time problems at Day 7||0.83|-5.98|0.1354
71736727|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean difference|1.86||||0.2722|TWO_SIDED|95.0|-1.5|5.21||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep time problems at Day 7||5.21|-1.50|0.2722
71736728|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean difference|-0.71||||0.6195|TWO_SIDED|95.0|-3.55|2.14||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on walking in the morning at Day 7||2.14|-3.55|0.6195
71736729|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.83||||0.0099|TWO_SIDED|95.0|-6.7|-0.96||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at day 7 for symptoms for walking in the morning||-0.96|-6.70|0.0099
71736730|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean Difference|3.12||||0.0298|TWO_SIDED|95.0|0.32|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 7||5.93|0.32|0.0298
71736731|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3||||0.7211|TWO_SIDED|95.0|-2.01|1.4||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||1.40|-2.01|0.7211
71736732|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean difference|-0.8||||0.35|TWO_SIDED|95.0|-2.51|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||0.90|-2.51|0.3500
71736733|NCT01122849|142987907|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.5564|TWO_SIDED|95.0|-1.19|2.18||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7||2.18|-1.19|0.5564
71736734|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.6804|TWO_SIDED|95.0|-2.2|3.35||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Sleep Problems at Day 14||3.35|-2.20|0.6804
71736735|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.31||||0.3524|TWO_SIDED|95.0|-4.12|1.49||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||1.49|-4.12|0.3524
71890266|NCT03952559|143302124|SUPERIORITY||LS Mean difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|2.168||0.4852|TWO_SIDED|95.0|-5.77|2.75|||Mixed Models Analysis|||||2.75|-5.77|0.4852
71660341|NCT03056157|142835046|SUPERIORITY||Odds Ratio (OR)|2.35||||0.03|TWO_SIDED|95.0|1.01|5.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.56|1.01|0.03
71736736|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean Difference|1.89||||0.1739|TWO_SIDED|95.0|-0.86|4.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14||4.63|-0.86|0.1739
71736737|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean difference|1.98||||0.2463|TWO_SIDED|95.0|-1.41|5.36||Between treatment p-values and confidence intervals|ANCOVA|Between treatment p-values and confidence intervals||Comparison for Sleep time problems at Day 14||5.36|-1.41|0.2463
71736738|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean difference|0.28||||0.8677|TWO_SIDED|95.0|-3.11|3.68|||ANCOVA|||Comparison for sleep time problems at Day 14||3.68|-3.11|0.8677
71736739|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.3136|TWO_SIDED|95.0|-1.65|5.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep time problems at Day 14||5.04|-1.65|0.3136
71736740|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.9183|TWO_SIDED|95.0|-2.93|2.65||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||2.65|-2.93|0.9183
71736741|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean difference|-2.68||||0.0614|TWO_SIDED|95.0|-5.5|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||0.13|-5.50|0.0614
71736742|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean Difference|2.54||||0.0695|TWO_SIDED|95.0|-0.21|5.29||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14||5.29|-0.21|0.0695
71736743|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.4947|TWO_SIDED|95.0|-1.03|2.1||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day14||2.10|-1.03|0.4947
71736744|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean difference|0.15||||0.8454|TWO_SIDED|95.0|-1.42|1.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.72|-1.42|0.8454
71736745|NCT01122849|142987908|SUPERIORITY_OR_OTHER||LS Mean difference|0.38||||0.6223|TWO_SIDED|95.0|-1.17|1.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14||1.93|-1.17|0.6223
71736746|NCT01122849|142987909|SUPERIORITY_OR_OTHER||LS Mean difference|-1.34||||0.4258|TWO_SIDED|95.0|-4.68|2.01||Between treatment p-values and confidence intervals|LS Mean Difference|||Comparison at Day 7||2.01|-4.68|0.4258
71736747|NCT01122849|142987909|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05||||0.0764|TWO_SIDED|95.0|-6.43|0.33||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||0.33|-6.43|0.0764
71736748|NCT01122849|142987909|SUPERIORITY_OR_OTHER||LS Mean Difference|1.71||||0.2986|TWO_SIDED|95.0|-1.56|4.97||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7||4.97|-1.56|0.2986
71736749|NCT01122849|142987910|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.482|TWO_SIDED|95.0|-2.05|4.29||Between treatment p-values and confidence intervals|ANCOVA|||||4.29|-2.05|0.4820
71736750|NCT01122849|142987910|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.81||||0.2607|TWO_SIDED|95.0|-5.02|1.39||Between treatment p-values and confidence intervals|ANCOVA|||||1.39|-5.02|0.2607
71736751|NCT01122849|142987910|SUPERIORITY_OR_OTHER||LS Mean Difference|2.93||||0.0623|TWO_SIDED|95.0|-0.16|6.02||Between treatment p-values and confidence intervals|ANCOVA|||||6.02|-0.16|0.0623
71736752|NCT01122849|142987911|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.36||||0.5278|TWO_SIDED|95.0|-18.1|9.39||Between treatment p-values and confidence intervals|ANCOVA|||||9.39|-18.1|0.5278
71736753|NCT01122849|142987911|SUPERIORITY_OR_OTHER||LS Mean Difference|10.14||||0.1458|TWO_SIDED|95.0|-3.64|23.93||Between treatment p-values and confidence intervals|ANCOVA|||||23.93|-3.64|0.1458
71736754|NCT01122849|142987911|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.5||||0.037|TWO_SIDED|95.0|-28.1|-0.91||Between treatment p-values and confidence intervals.|ANCOVA|||||-0.91|-28.1|0.0370
71736755|NCT01122849|142987912|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1||||0.4483|TWO_SIDED|95.0|-18.5|8.29|||ANCOVA|Between treatment p-values and confidence intervals||||8.29|-18.5|0.4483
71736756|NCT01122849|142987912|SUPERIORITY_OR_OTHER||LS Mean Difference|14.28||||0.0385|TWO_SIDED|95.0|0.79|27.77|||ANCOVA|Between treatment p-values and confidence intervals||||27.77|0.79|0.0385
71736757|NCT01122849|142987912|SUPERIORITY_OR_OTHER||LS Mean difference|-19.37||||0.0046|TWO_SIDED|95.0|-32.5|-6.23|||ANCOVA|Between treatment p-values and confidence intervals||||-6.23|-32.5|0.0046
71736758|NCT01122849|142987913|SUPERIORITY_OR_OTHER||LS Mean Difference|15.24||||0.0029|TWO_SIDED|95.0|5.45|25.02||Between treatment p-values and confidence intervals|ANCOVA|||||25.02|5.45|0.0029
71736759|NCT01122849|142987913|SUPERIORITY_OR_OTHER||LS Mean Difference|3.74||||0.4683|TWO_SIDED|95.0|-6.53|14.01||Between treatment p-values and confidence intervals|ANCOVA|||||14.01|-6.53|0.4683
71736760|NCT01122849|142987913|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0259|TWO_SIDED|95.0|1.44|21.55||Between treatment p-values and confidence intervals|ANCOVA|||||21.55|1.44|0.0259
71736761|NCT01122849|142987914|SUPERIORITY_OR_OTHER||LS Mean Difference|7.79||||0.1764|TWO_SIDED|95.0|-3.62|19.19||Between treatment p-values and confidence intervals|ANCOVA|||||19.19|-3.62|0.1764
71736762|NCT01122849|142987914|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63||||0.9183|TWO_SIDED|95.0|-11.7|12.94||Between treatment p-values and confidence intervals|ANCOVA|||||12.94|-11.7|0.9183
71736763|NCT01122849|142987914|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.2313||95.0|-4.7|19.01||Between treatment p-values and confidence intervals|ANCOVA|||||19.01|-4.70|0.2313
71736764|NCT01122849|142987915|SUPERIORITY_OR_OTHER||LS Mean difference|0.27||||0.1345|TWO_SIDED|95.0|-0.09|0.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.63|-0.09|0.1345
71890267|NCT03952559|143302124|SUPERIORITY||LS Mean difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.16||0.4205|TWO_SIDED|95.0|-5.98|2.5|||Mixed Models Analysis|||||2.50|-5.98|0.4205
71736765|NCT01122849|142987915|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.0815|TWO_SIDED|95.0|-0.68|0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.04|-0.68|0.0815
71736766|NCT01122849|142987915|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.0015|TWO_SIDED|95.0|0.24|0.94||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.94|0.24|0.0015
71736767|NCT01122849|142987915|SUPERIORITY_OR_OTHER||LS mean differnence|-1.03||||0.0292||95.0|-1.96|-0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.11|-1.96|0.0292
71736768|NCT01122849|142987915|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.2497|TWO_SIDED|95.0|-0.39|1.47||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.47|-0.39|0.2497
71736769|NCT01122849|142987915|SUPERIORITY_OR_OTHER||LS Mean difference|-1.57||||0.0011|TWO_SIDED|95.0|-2.48|-0.66||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||-0.66|-2.48|0.0011
71736770|NCT01122849|142987916|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.8063|TWO_SIDED|95.0|-0.4|0.51||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.51|-0.40|0.8063
71736771|NCT01122849|142987916|SUPERIORITY_OR_OTHER||LS Mean Differnence|-0.35||||0.1356|TWO_SIDED|95.0|-0.82|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.11|-0.82|0.1356
71736772|NCT01122849|142987916|SUPERIORITY_OR_OTHER||LS mean Difference|0.41||||0.0786|TWO_SIDED|95.0|-0.05|0.87|||ANCOVA|||Comparison for Q2 at Day 14||0.87|-0.05|0.0786
71736773|NCT01122849|142987916|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.72||||0.1693|TWO_SIDED|95.0|-1.75|0.32||Between treatment p-values and confidence intervals|ANCOVA|||Comparisons for Q4 at Day 14||0.32|-1.75|0.1693
71736774|NCT01122849|142987916|SUPERIORITY_OR_OTHER||LS Mean difference|1.08||||0.0438|TWO_SIDED|95.0|0.03|2.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.13|0.03|0.0438
71736775|NCT01122849|142987916|SUPERIORITY_OR_OTHER||LS Mean difference|-1.8||||0.0009|TWO_SIDED|95.0|-2.82|-0.78||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||-0.78|-2.82|0.0009
71736776|NCT01122849|142987917|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.1991|TWO_SIDED|95.0|-0.62|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7||0.13|-0.62|0.1991
71736777|NCT01122849|142987917|SUPERIORITY_OR_OTHER||LS Mean difference|-0.21||||0.2964|TWO_SIDED|95.0|-0.6|0.19||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.19|-0.60|0.2964
71736778|NCT01122849|142987917|SUPERIORITY_OR_OTHER||LS mean difference|-0.04||||0.8495|TWO_SIDED|95.0|-0.42|0.35||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7||0.35|-0.42|0.8495
71736779|NCT01122849|142987917|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.0381|TWO_SIDED|95.0|0.08|2.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7||2.62|0.08|0.0381
71736780|NCT01122849|142987917|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.4005|TWO_SIDED|95.0|-0.74|1.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||1.82|-0.74|0.4005
71736781|NCT01122849|142987917|SUPERIORITY_OR_OTHER||LS mean difference|0.81||||0.202|TWO_SIDED|95.0|-0.45|2.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7||2.07|-0.45|0.2020
71736782|NCT01122849|142987918|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.5741|TWO_SIDED|95.0|-0.41|0.23||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.23|-0.41|0.5741
71736783|NCT01122849|142987918|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.6935|TWO_SIDED|95.0|-0.26|0.39||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14||0.39|-0.26|0.6935
71736784|NCT01122849|142987918|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.333|TWO_SIDED|95.0|-0.47|0.16||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q2 at Day 14||0.16|-0.47|0.3330
71736785|NCT01122849|142987918|SUPERIORITY_OR_OTHER||LS Mean difference|1.39||||0.0434|TWO_SIDED|95.0|0.04|2.73||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||2.73|0.04|0.0434
71736786|NCT01122849|142987918|SUPERIORITY_OR_OTHER||LS Mean difference|0.32||||0.6333|TWO_SIDED|95.0|-1.02|1.67||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14||1.67|-1.02|0.6333
71736787|NCT01122849|142987918|SUPERIORITY_OR_OTHER||LS mean difference|1.06||||0.1091|TWO_SIDED|95.0|-0.25|2.37||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Q4 at Day 14||2.37|-0.25|0.1091
71736788|NCT03997825|142987937|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71736789|NCT03997825|142987938|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71736790|NCT00383162|142987943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.001||95.0|2.17|9.36|||Generalized Estimating Equations|||||9.36|2.17|<0.001
71890268|NCT03952559|143302124|SUPERIORITY||LS Mean difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.161||0.0138|TWO_SIDED|95.0|-9.59|-1.1|||Mixed Models Analysis|||||-1.10|-9.59|0.0138
71736791|NCT00767819|142987962|SUPERIORITY|The lower limit of the confidence interval was used to support the decision in favor of p0 or p1: if the lower limit of the confidence interval overlapped p0, the hypothesis that p is greater than or equal to p1 could be rejected; on the other side, if the lower limit of the confidence interval excluded p0, the hypothesis that p is greater than or equal to p1 could be accepted.|percentage of participants|40.5||||0.1|TWO_SIDED|80.0|29.5|52.4|||Clopper-Person confidence interval|||||52.4|29.5|0.1
71736792|NCT00915551|142987996|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71736793|NCT00915551|142987997|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71736794|NCT00235716|142987998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.15||||0.03|TWO_SIDED|95.0|0.92|5.39||p-value adjusted for 6 treatment group comparisons.|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||5.39|0.92|0.03
71736795|NCT00235716|142987998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.98||||0.4|TWO_SIDED|95.0|-0.24|4.2||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.20|-0.24|0.40
71736796|NCT00235716|142987998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.76||||0.49|TWO_SIDED|95.0|-0.48|4.0||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||4.00|-0.48|0.49
71736797|NCT00235716|142987998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.6|TWO_SIDED|95.0|-3.63|0.85||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.85|-3.63|0.60
71774339|NCT00667602|143048883|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
71890269|NCT03952559|143302125|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71736798|NCT00235716|142987998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.85|TWO_SIDED|95.0|-2.44|2.01||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||2.01|-2.44|0.85
71736799|NCT00235716|142987998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.6|TWO_SIDED|95.0|-1.04|3.39||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.39|-1.04|0.60
71736800|NCT00235716|142987999|SUPERIORITY_OR_OTHER|||||||0.69||||||p- value is unadjusted for multiple comparisons because its a 3 degrees of freedom test for any treatment group differences|Log Rank|3 degrees of freedom test||||||0.69
71736801|NCT00235716|142988000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.84|TWO_SIDED|95.0|-0.54|0.92||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.92|-0.54|0.84
71736802|NCT00235716|142988000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.84|TWO_SIDED|95.0|-0.61|0.84||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.84|-0.61|0.84
71736803|NCT00235716|142988000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.84|TWO_SIDED|95.0|-0.36|1.1||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.10|-0.36|0.84
71890270|NCT03952559|143302125|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.540
71890271|NCT03952559|143302125|SUPERIORITY|||||||0.302|||||||Fisher Exact|||||||0.302
71736804|NCT00235716|142988000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.84||95.0|-0.56|0.9||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.90|-0.56|0.84
71736805|NCT00235716|142988000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.84|TWO_SIDED|95.0|-0.47|0.98||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.98|-0.47|0.84
71774340|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-13.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-13|
71774341|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-12.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-12|
71774342|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.||2|-11|
71774343|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-3|
71774344|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-19.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-19|
71774345|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||TWO_SIDED|95.0|-17.0|-2.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-2|-17|
71774346|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||1|-12|
71890272|NCT03952559|143302126|SUPERIORITY||LS Mean difference (Final Values)|4.47|STANDARD_ERROR_OF_MEAN|5.03||0.375|TWO_SIDED|95.0|-5.41|14.35|||ANOVA|||||14.35|-5.41|0.375
71890273|NCT03952559|143302126|SUPERIORITY||LS Mean difference (Final Values)|3.12|STANDARD_ERROR_OF_MEAN|5.03||0.536|TWO_SIDED|95.0|-6.76|13.0|||ANOVA|||||13.00|-6.76|0.536
71890274|NCT03952559|143302126|SUPERIORITY||LS Mean difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|5.03||0.016|TWO_SIDED|95.0|2.29|22.05|||ANOVA|||||22.05|2.29|0.016
71890275|NCT03952559|143302127|SUPERIORITY||LS Mean difference (Final Values)|-49.19|STANDARD_ERROR_OF_MEAN|27.28||0.073|TWO_SIDED|95.0|-102.81|4.42|||ANOVA|||||4.42|-102.81|0.073
71890276|NCT03952559|143302127|SUPERIORITY||LS Mean difference (Final Values)|-37.38|STANDARD_ERROR_OF_MEAN|27.29||0.172|TWO_SIDED|95.0|-91.0|16.23|||ANOVA|||||16.23|-91.00|0.172
71736806|NCT00235716|142988000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.84|TWO_SIDED|95.0|-0.65|0.8||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.80|-0.65|0.84
71736807|NCT00235716|142988001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.1|TWO_SIDED|95.0|-3.28|-0.33||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.33|-3.28|0.10
71736808|NCT00235716|142988001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39||||0.25|TWO_SIDED|95.0|-2.85|0.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.07|-2.85|0.25
71736809|NCT00235716|142988001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.65||||0.14|TWO_SIDED|95.0|-3.12|-0.17||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.17|-3.12|0.14
71736810|NCT00235716|142988001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.84|TWO_SIDED|95.0|-1.32|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-1.32|0.84
71774347|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-12.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||4|-12|
71774348|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-11|
71774349|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-10|
71889959|NCT03575104|143301814|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|19.06|||<|0.0001|TWO_SIDED|95.0|10.125|27.994||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00781; statistically significant = YES||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).||27.994|10.125|<.0001
71736811|NCT00235716|142988001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.84|TWO_SIDED|95.0|-1.72|1.21||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.21|-1.72|0.84
71736812|NCT00235716|142988001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.84|TWO_SIDED|95.0|-1.88|1.06||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.06|-1.88|0.84
71774350|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||3|-4|
71832925|NCT04922021|143170302|SUPERIORITY|Two-sided hypotheses were tested based on the pre-specified primary analysis for the primary estimand. The primary estimand used a hypothetical strategy evaluating the treatment difference as if all subjects adhered to the treatment regimen, i.e. they did not discontinue IMP permanently, did not initiate rescue treatment, or did not have more than one missed treatment dose related to COVID-19.|Mean Difference (Net)|-11.8||||0.003|TWO_SIDED|95.0|-19.6|-4.1||The type I error rate of the two-sided hypothesis test was controlled at the 5% significance level.|ANCOVA|ANCOVA model: Change in EASI = Treatment + Region + Baseline EASI. Missing values and data 'treated as missing' were imputed using MI assuming MAR.|Estimates of difference in LS-means and associated standard errors from the analyses were combined using Rubin's rule to provide the overall pooled estimate and associated standard error. LS-means was estimated using the observed margins for the FAS.|||-4.1|-19.6|0.003
71832926|NCT01285999|143170320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29||||0.05|TWO_SIDED|95.0|-0.37|-0.21||p-value has not been adjusted.|t-test, 2 sided|No adjustment.||H0: μt - μc = 0 H1: μt - μc ≠ 0 where μt and μc are the mean 9-month in-stent late loss values for the subjects in the PROMUS Element test and TAXUS Liberté control treatment groups, respectively.||-0.21|-0.37|0.05
71890277|NCT03952559|143302127|SUPERIORITY||LS Mean difference (Final Values)|-80.37|STANDARD_ERROR_OF_MEAN|27.28||0.004|TWO_SIDED|95.0|-133.98|-26.75|||ANOVA|||||-26.75|-133.98|0.004
71736813|NCT00235716|142988002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.46||||0.94|TWO_SIDED|95.0|-3.55|0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.63|-3.55|0.94
71736814|NCT00235716|142988002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.94|TWO_SIDED|95.0|-2.47|1.7||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.70|-2.47|0.94
71736815|NCT00235716|142988002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.94|TWO_SIDED|95.0|-2.57|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.63|-2.57|0.94
71736816|NCT00235716|142988002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.94|TWO_SIDED|95.0|-1.09|3.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.07|-1.09|0.94
71736817|NCT00235716|142988002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.94|TWO_SIDED|95.0|-2.16|1.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.99|-2.16|0.94
71890278|NCT03952559|143302128|SUPERIORITY||LS Mean difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.372||0.0829|TWO_SIDED|95.0|-1.38|0.08|||Mixed Models Analysis|||||0.08|-1.38|0.0829
71736818|NCT00235716|142988002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.08||||0.94|TWO_SIDED|95.0|-3.14|0.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||0.99|-3.14|0.94
71736819|NCT00235716|142988003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.79||||0.12|TWO_SIDED|95.0|-3.35|-0.23||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.23|-3.35|0.12
71736820|NCT00235716|142988003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.86|TWO_SIDED|95.0|-1.18|1.94||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.94|-1.18|0.86
71832927|NCT02566902|143170475|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71832928|NCT02566902|143170476|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71832929|NCT02566902|143170477|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71890279|NCT03952559|143302128|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.368||0.1752|TWO_SIDED|95.0|-1.22|0.22|||Mixed Models Analysis|||||0.22|-1.22|0.1752
71890280|NCT03952559|143302128|SUPERIORITY||LS Mean difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.366||0.0029|TWO_SIDED|95.0|-1.82|-0.38|||Mixed Models Analysis|||||-0.38|-1.82|0.0029
71736821|NCT00235716|142988003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.86|TWO_SIDED|95.0|-1.7|1.42||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.42|-1.70|0.86
71736822|NCT00235716|142988003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||0.14|TWO_SIDED|95.0|0.11|3.19||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||3.19|0.11|0.14
71736823|NCT00235716|142988003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.86|TWO_SIDED|95.0|-2.07|1.02||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||1.02|-2.07|0.86
71832930|NCT02566902|143170478|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
71736824|NCT00235716|142988003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.17||||0.03|TWO_SIDED|95.0|-3.71|-0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.||-0.63|-3.71|0.03
71736825|NCT00235716|142988004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.13||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for vitamin E group relative to the placebo group.|||1.13|0.67|0.31
71736826|NCT00235716|142988004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.47|TWO_SIDED|95.0|0.91|1.24||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the memantine group relative to the placebo group.|||1.24|0.91|0.47
71889960|NCT03575104|143301814|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|13.58|||=|0.0028|TWO_SIDED|95.0|4.691|22.475||Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 10 mg vs placebo).||22.475|4.691|= 0.0028
71890281|NCT03952559|143302129|SUPERIORITY||LS Mean difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.193||0.2688|TWO_SIDED|95.0|-0.6|0.17|||Mixed Models Analysis|||||0.17|-0.60|0.2688
71890282|NCT03952559|143302129|SUPERIORITY||LS Mean difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.193||0.0166|TWO_SIDED|95.0|-0.85|-0.09|||Mixed Models Analysis|||||-0.09|-0.85|0.0166
71736827|NCT00235716|142988004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.57|1.54||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the vitamin E + memantine group relative to the placebo group.|||1.54|0.57|0.80
71736828|NCT03036189|142988009|SUPERIORITY||Slope|-0.15||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
71736829|NCT03036189|142988010|SUPERIORITY||Slope|0.42||||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
71736830|NCT03036189|142988011|SUPERIORITY||Slope|0.12||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71736831|NCT03036189|142988012|SUPERIORITY||Slope|0.37||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
71736832|NCT03036189|142988013|SUPERIORITY||Slope|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
71736833|NCT03036189|142988014|SUPERIORITY||Slope|0.49||||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
71736834|NCT03036189|142988015|SUPERIORITY||Slope|-0.03||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
71736835|NCT03036189|142988016|SUPERIORITY||Slope|0.45||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
71736836|NCT03036189|142988017|SUPERIORITY||Slope|0.25||||0.77|TWO_SIDED||||||Mixed Models Analysis|||||||0.77
71736837|NCT03036189|142988018|SUPERIORITY||Slope|0.54|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71736838|NCT03036189|142988019|SUPERIORITY||Slope|1.99||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
71736839|NCT03036189|142988020|SUPERIORITY||Slope|1.05||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71736840|NCT03036189|142988021|SUPERIORITY||Slope|2.0||||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
71736841|NCT03036189|142988022|SUPERIORITY||Slope|-23.01||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
71832931|NCT02566902|143170479|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
71832932|NCT02566902|143170480|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71832933|NCT00520546|143170487|SUPERIORITY_OR_OTHER||sensitivity|97.0||||0.0526|TWO_SIDED|95.0|86.0|100.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|86|0.0526
71832934|NCT00520546|143170487|SUPERIORITY_OR_OTHER||specificity|0.0||||0.0526|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|0.0526
71890283|NCT03952559|143302129|SUPERIORITY||LS Mean difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0908|TWO_SIDED|95.0|-0.75|0.06|||Mixed Models Analysis|||||0.06|-0.75|0.0908
71832935|NCT00520546|143170487|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0526|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0526
71736842|NCT00148941|142988088|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.97|||||TWO_SIDED|95.0|0.871|1.08|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.080|0.871|
71832936|NCT00520546|143170487|SUPERIORITY_OR_OTHER||sensitivity|70.0|||<|0.0001|TWO_SIDED|95.0|53.0|84.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||84|53|<0.0001
71832937|NCT00520546|143170487|SUPERIORITY_OR_OTHER||specificity|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|98.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||98|0|<0.0001
71832938|NCT00520546|143170487|SUPERIORITY_OR_OTHER||accuracy|68.0|||<|0.0001|TWO_SIDED|95.0|51.0|83.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||83|51|<0.0001
71736843|NCT00148941|142988088|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.961|||||TWO_SIDED|95.0|0.863|1.07|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.070|0.863|
71889961|NCT03575104|143301815|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.75|||=|0.0733|TWO_SIDED|95.0|-1.581|0.071||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00625; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).||0.071|-1.581|= 0.0733
71890284|NCT03952559|143302130|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.956||0.3409|TWO_SIDED|95.0|-2.79|0.97|||Mixed Models Analysis|||||0.97|-2.79|0.3409
71660342|NCT03056157|142835046|SUPERIORITY||Odds Ratio (OR)|0.0||||0.01|TWO_SIDED|95.0|0.0|0.71|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced improvement from baseline to post-treatment in SDS in AD-MIL versus PCT.||0.71|0|0.01
71736844|NCT00148941|142988088|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.991|||||TWO_SIDED|95.0|0.89|1.103|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.103|0.890|
71660343|NCT03056157|142835046|SUPERIORITY||Odds Ratio (OR)|0.82||||0.69|TWO_SIDED|95.0|0.35|1.87|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced no change in SDS from baseline to post-treatment in AD-MIL versus PCT.||1.87|0.35|.69
71736845|NCT00148941|142988088|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.975|||||TWO_SIDED|95.0|0.866|1.097|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.097|0.866|
71832939|NCT00520546|143170487|SUPERIORITY_OR_OTHER||sensitivity|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
71832940|NCT00520546|143170487|SUPERIORITY_OR_OTHER||specificity|100.0||||0.0043|TWO_SIDED|95.0|3.0|100.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||100|3|0.0043
71832941|NCT00520546|143170487|SUPERIORITY_OR_OTHER||accuracy|95.0||||0.0043|TWO_SIDED|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."||99|82|0.0043
71832942|NCT00520546|143170488|SUPERIORITY_OR_OTHER||positive prediction|69.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
71832943|NCT00520546|143170488|SUPERIORITY_OR_OTHER||negative prediction|44.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
71736846|NCT00148941|142988088|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.878|||||TWO_SIDED|95.0|0.78|0.988|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.988|0.780|
71736847|NCT00148941|142988088|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.901|||||TWO_SIDED|95.0|0.8|1.014|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.014|0.800|
71736848|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.938|||||TWO_SIDED|95.0|0.828|1.063|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.063|0.828|
71736849|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.963|||||TWO_SIDED|95.0|0.85|1.091|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.091|0.850|
71736850|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.026|||||TWO_SIDED|95.0|0.906|1.162|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.162|0.906|
71736851|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.874|||||TWO_SIDED|95.0|0.783|0.976|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||0.976|0.783|
71832944|NCT00520546|143170488|SUPERIORITY_OR_OTHER||sensitivity|71.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
71889962|NCT03575104|143301815|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.43|||=|0.3048|TWO_SIDED|95.0|-1.251|0.392||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 10 mg vs placebo).||0.392|-1.251|= 0.3048
71736852|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.947|||||TWO_SIDED|95.0|0.849|1.057|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.057|0.849|
71736853|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.084|||||TWO_SIDED|95.0|0.971|1.209|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.209|0.971|
71832945|NCT00520546|143170488|SUPERIORITY_OR_OTHER||specificity|42.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
71736854|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|0.998|||||TWO_SIDED|95.0|0.867|1.148|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.148|0.867|
71832946|NCT00520546|143170488|SUPERIORITY_OR_OTHER||accuracy|61.0||||0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.09
71832947|NCT00520546|143170488|SUPERIORITY_OR_OTHER||positive prediction|60.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71832948|NCT00520546|143170488|SUPERIORITY_OR_OTHER||negative prediction|30.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71832949|NCT00520546|143170488|SUPERIORITY_OR_OTHER||sensitivity|48.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71832950|NCT00520546|143170488|SUPERIORITY_OR_OTHER||specificity|40.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71832951|NCT00520546|143170488|SUPERIORITY_OR_OTHER||accuracy|45.0||||0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.27
71832952|NCT00520546|143170488|SUPERIORITY_OR_OTHER||positive prediction|87.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832953|NCT00520546|143170488|SUPERIORITY_OR_OTHER||negative prediction|57.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71889963|NCT03575104|143301816|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-1.25|||=|0.012|TWO_SIDED|95.0|-2.23|-0.276||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0.00391; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).||-0.276|-2.230|= 0.0120
71890285|NCT03952559|143302130|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.952||0.1022|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1022
71832954|NCT00520546|143170488|SUPERIORITY_OR_OTHER||sensitivity|66.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832955|NCT00520546|143170488|SUPERIORITY_OR_OTHER||specificity|82.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832956|NCT00520546|143170488|SUPERIORITY_OR_OTHER||accuracy|72.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832957|NCT00520546|143170489|SUPERIORITY_OR_OTHER||positive prediction|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832958|NCT00520546|143170489|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832959|NCT00520546|143170489|SUPERIORITY_OR_OTHER||sensitivity|90.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832960|NCT00520546|143170489|SUPERIORITY_OR_OTHER||specificity|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832961|NCT00520546|143170489|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71736855|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.043|||||TWO_SIDED|95.0|0.907|1.2|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.200|0.907|
71736856|NCT00148941|142988089|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMC ratio|1.045|||||TWO_SIDED|95.0|0.909|1.202|||ANCOVA|Ancova model: adjustment for baseline concentration - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.202|0.909|
71736857|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.994|||||TWO_SIDED|95.0|0.836|1.181|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.181|0.836|
71736858|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.987|||||TWO_SIDED|95.0|0.831|1.172|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.172|0.831|
71736859|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.993|||||TWO_SIDED|95.0|0.836|1.18|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.180|0.836|
71774351|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-15.0|||||TWO_SIDED|95.0|-24.0|-6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-6|-24|
71832962|NCT00520546|143170489|SUPERIORITY_OR_OTHER||positive prediction|71.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
71832963|NCT00520546|143170489|SUPERIORITY_OR_OTHER||negative prediction|33.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
71890286|NCT03952559|143302130|SUPERIORITY||LS Mean difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.953||0.1024|TWO_SIDED|95.0|-3.43|0.31|||Mixed Models Analysis|||||0.31|-3.43|0.1024
71890287|NCT03952559|143302131|SUPERIORITY||LS Mean difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.157||0.1436|TWO_SIDED|95.0|-0.54|0.08|||Mixed Models Analysis|||||0.08|-0.54|0.1436
71736860|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.118|||||TWO_SIDED|95.0|0.951|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.951|
71774352|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-9.0|||||TWO_SIDED|95.0|-17.0|-1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||-1|-17|
71832964|NCT00520546|143170489|SUPERIORITY_OR_OTHER||sensitivity|73.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
71890288|NCT03952559|143302131|SUPERIORITY||LS Mean difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.154||0.0483|TWO_SIDED|95.0|-0.61|0.0|||Mixed Models Analysis|||||-0.00|-0.61|0.0483
71736861|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.006|||||TWO_SIDED|95.0|0.856|1.183|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.183|0.856|
71832965|NCT00520546|143170489|SUPERIORITY_OR_OTHER||specificity|31.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
71832966|NCT00520546|143170489|SUPERIORITY_OR_OTHER||accuracy|60.0||||0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.53
71832967|NCT00520546|143170489|SUPERIORITY_OR_OTHER||positive prediction|96.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832968|NCT00520546|143170489|SUPERIORITY_OR_OTHER||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832969|NCT00520546|143170489|SUPERIORITY_OR_OTHER||sensitivity|87.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832970|NCT00520546|143170489|SUPERIORITY_OR_OTHER||specificity|92.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832971|NCT00520546|143170489|SUPERIORITY_OR_OTHER||accuracy|88.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score \>6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71890289|NCT03952559|143302131|SUPERIORITY||LS Mean difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.154||0.0012|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||||-0.20|-0.80|0.0012
71736862|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\] for Anti-poliovirus type 2.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.765|1.06|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.060|0.765|
71890290|NCT03952559|143302132|SUPERIORITY||LS Mean difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|1.755||0.9183|TWO_SIDED|95.0|-3.27|3.63|||Mixed Models Analysis|||for 8 to \<18 years old||3.63|-3.27|0.9183
71890291|NCT03952559|143302132|SUPERIORITY||LS Mean difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.529||0.4805|TWO_SIDED|95.0|-4.09|1.93|||Mixed Models Analysis|||for 8 to \<18 years old||1.93|-4.09|0.4805
71890292|NCT03952559|143302132|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.812||0.3488|TWO_SIDED|95.0|-5.26|1.86|||Mixed Models Analysis|||for 8 to \<18 years old||1.86|-5.26|0.3488
71832972|NCT00520546|143170490|SUPERIORITY_OR_OTHER||positive prediction|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
71832973|NCT00520546|143170490|SUPERIORITY_OR_OTHER||negative prediction|69.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
71832974|NCT00520546|143170490|SUPERIORITY_OR_OTHER||sensitivity|86.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
71832975|NCT00520546|143170490|SUPERIORITY_OR_OTHER||specificity|43.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
71832976|NCT00520546|143170490|SUPERIORITY_OR_OTHER||accuracy|67.0||||0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.002
71832977|NCT00520546|143170490|SUPERIORITY_OR_OTHER||positive prediction|59.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
71774353|NCT00667602|143048884|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.||0|-13|
71774354|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|71.0|||||TWO_SIDED|95.0|63.0|78.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||78|63|
71774355|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||6|-3|
71774356|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||7|-2|
71774357|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
71774358|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|31.0|||||TWO_SIDED|95.0|24.0|39.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||39|24|
71736863|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.112|||||TWO_SIDED|95.0|0.941|1.314|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.314|0.941|
71736864|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|1.034|||||TWO_SIDED|95.0|0.876|1.22|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.220|0.876|
71774359|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||4|-2|
71832978|NCT00520546|143170490|SUPERIORITY_OR_OTHER||negative prediction|46.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
71890293|NCT03952559|143302132|SUPERIORITY||LS Mean difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|3.12||0.2388|TWO_SIDED|95.0|-4.85|7.66|||Mixed Models Analysis|||for 5 to \<8 years old||7.66|-4.85|0.2388
71736865|NCT00148941|142988090|EQUIVALENCE|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of \[0.67; 1.5\].|GMT ratio|0.93|||||TWO_SIDED|95.0|0.787|1.099|||ANCOVA|Ancova model: adjustment for baseline titer - pooled variance with more than 2 groups.||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.||1.099|0.787|
71832979|NCT00520546|143170490|SUPERIORITY_OR_OTHER||sensitivity|66.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
71832980|NCT00520546|143170490|SUPERIORITY_OR_OTHER||specificity|38.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
71774360|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||11|-3|
71774361|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-13.0|||||TWO_SIDED|95.0|-22.0|-5.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-5|-22|
71774362|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-10.0|||||TWO_SIDED|95.0|-17.0|-4.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||-4|-17|
71774363|NCT00667602|143048889|NON_INFERIORITY_OR_EQUIVALENCE|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||Miettinen and Nurminen|Difference between the two groups and the associated 95% CIs were computed using the Miettinen and Nurminen method.||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.||1|-11|
71774364|NCT00667602|143048891|NON_INFERIORITY_OR_EQUIVALENCE|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Ratio|1.33|||||TWO_SIDED|95.0|0.96|1.83|||ANOVA|||For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.||1.83|0.96|
71774365|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.265|||||TWO_SIDED|95.0|0.998|1.603|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.603|0.998|
71774366|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.999|||||TWO_SIDED|95.0|0.791|1.262|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.262|0.791|
71774367|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.558|0.897|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.897|0.558|
71774368|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.861|||||TWO_SIDED|95.0|0.681|1.089|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.089|0.681|
71832981|NCT00520546|143170490|SUPERIORITY_OR_OTHER||accuracy|54.0||||0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||0.41
71889964|NCT03575104|143301816|OTHER|The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).|LS mean difference to placebo|-0.73|||=|0.1393|TWO_SIDED|95.0|-1.706|0.239||Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.|Mixed Models Analysis|Hypothesis testing result: threshold for significance p = 0; statistically significant = NO||Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 10 mg vs placebo).||0.239|-1.706|= 0.1393
71832982|NCT00520546|143170490|SUPERIORITY_OR_OTHER||positive prediction|86.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71890294|NCT03952559|143302132|SUPERIORITY||LS Mean difference (Final Values)|-3.13|STANDARD_ERROR_OF_MEAN|3.542||0.0098|TWO_SIDED|95.0|-10.23|3.98|||Mixed Models Analysis|||for 5 to \<8 years old||3.98|-10.23|0.0098
71736866|NCT00148941|142988090|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ration|0.792|||||TWO_SIDED|95.0|0.68|0.922|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.922|0.680|
71832983|NCT00520546|143170490|SUPERIORITY_OR_OTHER||negative prediction|76.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832984|NCT00520546|143170490|SUPERIORITY_OR_OTHER||sensitivity|83.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832985|NCT00520546|143170490|SUPERIORITY_OR_OTHER||specificity|80.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71832986|NCT00520546|143170490|SUPERIORITY_OR_OTHER||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions \>5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."||||<0.001
71660344|NCT03056157|142835046|SUPERIORITY||Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|0.0|0.0|5.83|||Fisher Exact|||Odds ratio comparison of the proportion of participants who experienced deterioration in SDS from baseline to post-treatment in AD-MIL versus PCT.||5.83|0|0.50
71736867|NCT00148941|142988090|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.802|||||TWO_SIDED|95.0|0.696|0.925|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.925|0.696|
71736868|NCT00148941|142988090|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.938|||||TWO_SIDED|95.0|0.811|1.085|||ANCOVA|ANCOVA model: adjustment for baseline titer - pooled variance||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.085|0.811|
71736869|NCT00148941|142988091|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.47|||||TWO_SIDED|95.0|-0.98|1.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.21|-0.98|
71736870|NCT00148941|142988091|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-2.81|||||TWO_SIDED|95.0|-6.55|-0.09||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|-0.09|-6.55|
71832987|NCT00595790|143170491|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of non-inferiority of IC51 1x12 mcg vs. IC51 2x6 mcg at Day 56 based on the difference (IC51 1x12 mcg - IC51 2x6 mcg) in SCRs in the PP population. Non-inferiority of IC51 1 x 12 mcg compared to IC51 2 x 6 mcg was accepted if the lower limit of the 95% CI of the adjusted for center SCR difference (IC51 1 x 12 mcg - IC51 2 x 6 mcg) was higher than the noninferiority margin at -10%.|||||>|0.99|||||||Mantel Haenszel|||||||>0.99
71832988|NCT04452318|143170513|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.09|0.332|||Regression, Logistic|||||0.332|0.090|< 0.0001
71660345|NCT03056157|142835047|SUPERIORITY||Slope|-3.39||||0.35|TWO_SIDED|95.0|-10.57|3.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.93, d = 0.10.||3.79|-10.57|0.35
71889965|NCT03575104|143301817|OTHER||LS mean difference to placebo|0.93||||0.2506|TWO_SIDED|95.0|0.82|1.05||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).||1.05|0.82|0.2506
71660346|NCT03056157|142835047|SUPERIORITY||Slope|-8.64||||0.001|TWO_SIDED|95.0|-13.83|-3.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for BIPF scores, t(116) = -3.27, d = 0.61.||-3.44|-13.83|0.001
71660347|NCT03056157|142835047|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
71736871|NCT00148941|142988092|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.36|||||TWO_SIDED|95.0|-3.83|3.71||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.71|-3.83|
71736872|NCT00148941|142988092|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.79|||||TWO_SIDED|95.0|-2.5|3.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|3.21|-2.50|
71736873|NCT00148941|142988092|NON_INFERIORITY|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-0.82|||||TWO_SIDED|95.0|-3.79|1.14||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|1.14|-3.79|
71736874|NCT00148941|142988093|NON_INFERIORITY|Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 \& 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.|Difference in percentage|-0.41|||||TWO_SIDED|95.0|-1.26|0.16||||||Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves \> 50% of the length of the upper arm that also is associated with a \> 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.|0.16|-1.26|
71774369|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.596|0.956|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.956|0.596|
71889966|NCT03575104|143301817|OTHER||LS mean difference to placebo|0.8||||0.0004|TWO_SIDED|95.0|0.71|0.91||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).||0.91|0.71|0.0004
71890295|NCT03952559|143302132|SUPERIORITY||LS Mean difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.14||0.1698|TWO_SIDED|95.0|-5.18|7.42|||Mixed Models Analysis|||for 5 to \<8 years old||7.42|-5.18|0.1698
71660348|NCT03056157|142835047|SUPERIORITY||Slope|-5.17||||0.08|TWO_SIDED|95.0|-10.86|0.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -1.79, d = 0.20.||0.52|-10.86|0.08
71660349|NCT03056157|142835047|SUPERIORITY||Slope|-5.64||||0.007|TWO_SIDED|95.0|-9.72|-1.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -2.72, d = 0.30.||-1.57|-9.72|0.007
71660350|NCT03056157|142835047|SUPERIORITY||Slope|-0.47||||0.82|TWO_SIDED|95.0|-4.44|3.5|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B-IPF scores, t(326) = -0.23, d = 0.03.||3.50|-4.44|0.82
71660351|NCT03056157|142835048|SUPERIORITY||Slope|-0.6||||0.75|TWO_SIDED|95.0|-4.68|3.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.32, d = 0.03.||3.36|-4.68|0.75
71660352|NCT03056157|142835048|SUPERIORITY||Slope|-9.12|||<|0.001|TWO_SIDED|95.0|-12.12|-6.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.01, d = 1.97.||-6.12|-12.12|<0.001
71736875|NCT03368235|142988116|OTHER||LS mean difference|0.472|STANDARD_ERROR_OF_MEAN|0.4569||0.315|TWO_SIDED|95.0|-0.487|1.431||Based on MMRM model with the baseline DAS28-CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||MMRM = mixed model repeated measures.||1.431|-0.487|0.315
71774370|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.548|||||TWO_SIDED|95.0|0.434|0.693|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.693|0.434|
71774371|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.51|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.817|0.510|
71774372|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.79|||||TWO_SIDED|95.0|0.625|1.0|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.000|0.625|
71774373|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.56|||||TWO_SIDED|95.0|0.441|0.71|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.710|0.441|
71774374|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.681|||||TWO_SIDED|95.0|0.538|0.862|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.862|0.538|
71832989|NCT04452318|143170514|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.038|TWO_SIDED|95.0|0.298|0.966|||Regression, Logistic|||||0.966|0.298|= 0.0380
71660353|NCT03056157|142835048|SUPERIORITY||Slope|-8.72|||<|0.001|TWO_SIDED|95.0|-11.16|-5.76|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(37) = -6.11, d = 2.01.||-5.76|-11.16|<0.001
71736876|NCT03368235|142988117|OTHER||Odds Ratio (OR)|0.807||||0.807|TWO_SIDED|95.0|0.12|5.34||Logistic regression model with the treatment group, country and baseline DAS28-CRP as covariate.|Regression, Logistic|||Treatment comparison ACR20: AZD9567 Vs prednisolone||5.34|0.12|0.807
71736877|NCT03368235|142988117|OTHER|||||||0.198|||||||Fisher Exact|||Treatment comparison ACR50: AZD9567 Vs prednisolone||||0.198
71774375|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.597|||||TWO_SIDED|95.0|0.47|0.757|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.757|0.470|
71736878|NCT03368235|142988117|OTHER|||||||0.183|||||||Fisher Exact|||Treatment comparison ACR70: AZD9567 Vs prednisolone||||0.183
71736879|NCT03368235|142988118|OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.136||0.717|TWO_SIDED|95.0|-1.98|2.81||The MMRM with the baseline SJC66 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.81|-1.98|0.717
71736880|NCT03368235|142988119|OTHER||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|3.115||0.724|TWO_SIDED|95.0|-7.69|5.46||The MMRM with the baseline TJC68 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||5.46|-7.69|0.724
71774376|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.434|||||TWO_SIDED|95.0|0.342|0.549|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.549|0.342|
71774377|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.511|||||TWO_SIDED|95.0|0.403|0.647|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.647|0.403|
71832990|NCT04452318|143170516|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.069|0.236|||Regression, Logistic|||||0.236|0.069|< 0.0001
71736881|NCT03368235|142988120|OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.6||0.973|TWO_SIDED|95.0|-3.43|3.32||The MMRM with the baseline TJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||3.32|-3.43|0.973
71736882|NCT03368235|142988121|OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.837||0.757|TWO_SIDED|95.0|-1.5|2.03||The MMRM with the baseline SJC28 score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||2.03|-1.50|0.757
71736883|NCT03368235|142988122|OTHER||LS mean difference|9.8|STANDARD_ERROR_OF_MEAN|9.67||0.325|TWO_SIDED|95.0|-10.5|30.1||The MMRM with the baseline GH score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||30.1|-10.5|0.325
71660354|NCT03056157|142835048|SUPERIORITY||Slope|-2.28||||0.56|TWO_SIDED|95.0|-10.08|5.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = -0.59, d = 0.06.||5.52|-10.08|0.56
71736884|NCT03368235|142988123|OTHER||LS mean difference|4.756|STANDARD_ERROR_OF_MEAN|3.4725||0.187|TWO_SIDED|95.0|-2.514|12.025||The MMRM with the baseline CRP score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||12.025|-2.514|0.187
71736885|NCT03368235|142988124|OTHER||LS mean difference|16.0|STANDARD_ERROR_OF_MEAN|10.49||0.144|TWO_SIDED|95.0|-6.0|38.1||The MMRM with the baseline participant's assessment of pain score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||38.1|-6.0|0.144
71736886|NCT03368235|142988125|OTHER||LS mean difference|3.8|STANDARD_ERROR_OF_MEAN|5.73||0.512|TWO_SIDED|95.0|-8.3|16.0||The MMRM with the baseline disease activity score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||16.0|-8.3|0.512
71736887|NCT03368235|142988126|OTHER||LS mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.2381||0.589|TWO_SIDED|95.0|-0.37|0.631||The MMRM with the baseline physical function score as a continuous covariate and country, visit and treatment group as categorical fixed effects, as well as visit interaction with treatment group, using unstructured covariance matrix.|MMRM|||||0.631|-0.370|0.589
71736888|NCT02160145|142988202|OTHER||Treatment difference|1.271|||<|0.0001|TWO_SIDED|95.0|0.859|1.684||A 2-sided alpha of 0.05 was applied to the primary analysis of the primary endpoint.|ANCOVA|Weighted Analysis of Covariance (ANCOVA) with effects of treatment and randomization stratification factors and covariate baseline.||Tolvaptan versus placebo. Treatment difference in the change of eGFR assessed the efficacy of tolvaptan treatment as compared with placebo in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period.||1.684|0.859|<0.0001
71736889|NCT02160145|142988203|OTHER||Treatment difference|1.011|||<|0.0001|TWO_SIDED|95.0|0.618|1.403||A two-sided alpha of 0.05 was applied when the primary endpoint reached a two-sided alpha of 0.05.|Mixed Models Analysis|||Difference in treatment effect was derived from a linear mixed model with effects of treatment, time, treatment ime interaction, acute haemodynamic effect, pretreatment baseline, and randomization stratification factors. An unstructured variance matrix was assumed for the random intercept and time.||1.403|0.618|<0.0001
71774378|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||TWO_SIDED|95.0|0.56|0.896|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.896|0.560|
71660355|NCT03056157|142835048|SUPERIORITY||Slope|4.2||||0.22|TWO_SIDED|95.0|-0.24|10.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 1.25, d = 0.13.||10.92|-0.24|0.22
71660356|NCT03056157|142835048|SUPERIORITY||Slope|6.6||||0.002|TWO_SIDED|95.0|2.52|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SDS scores for the COVID-19 cohort, t(373) = 3.18, d = 0.33.||10.69|2.52|0.002
71736890|NCT02964767|142988236|OTHER||||||<|0.049|||||||t-test, 2 sided|||||||<0.049
71736891|NCT01031979|142988268|SUPERIORITY_OR_OTHER||Beta|-1.44|||<|0.001|TWO_SIDED|95.0|-2.29|-0.59|||mixed effects/hierarchical linear model|||||-0.59|-2.29|<0.001
71774379|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.862|||||TWO_SIDED|95.0|0.683|1.088|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.088|0.683|
71774380|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.755|||||TWO_SIDED|95.0|0.597|0.954|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.954|0.597|
71736892|NCT01031979|142988269|SUPERIORITY_OR_OTHER||Slope|-0.87||||0.39|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.39
71736893|NCT01031979|142988270|SUPERIORITY_OR_OTHER||Slope|-0.55||||0.58|TWO_SIDED||||||Hierarchical Linear Modeling|||||||.58
71736894|NCT01031979|142988271|SUPERIORITY_OR_OTHER||Beta|-1.6||||0.03|TWO_SIDED|95.0|-2.71|-0.49|||Hierarchical Linear Modeling|||||-0.49|-2.71|.03
71736895|NCT03592368|142988275|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71736896|NCT03592368|142988277|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71736897|NCT03592368|142988278|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||||||0.12
71736898|NCT03831100|142988279|SUPERIORITY||Mean Difference (Net)|-2.1||||0.25|TWO_SIDED|90.0|-5.0|0.9||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.9|-5.0|0.25
71736899|NCT03831100|142988280|SUPERIORITY||Mean Difference (Net)|-5.8||||0.006|TWO_SIDED|90.0|-9.1|-2.5||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||-2.5|-9.1|.006
71736900|NCT03831100|142988281|SUPERIORITY||Mean Difference (Net)|-7.9||||0.1|TWO_SIDED|90.0|-15.9|0.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear||The mean for each study arm represents the mean difference in the score at the post-treatment timepoint relative to the score at baseline. The mean difference (net) represents the mean model-based difference between study arms.|||0.0|-15.9|.10
71736901|NCT03831100|142988282|SUPERIORITY||Mean Difference (Net)|-17.1||||0.002|TWO_SIDED|90.0|-25.6|-8.6||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|Regression, Linear|||||-8.6|-25.6|.002
71774381|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.549|||||TWO_SIDED|95.0|0.435|0.692|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.692|0.435|
71774382|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||TWO_SIDED|95.0|0.511|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.817|0.511|
71832991|NCT04452318|143170516|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0024|TWO_SIDED|95.0|0.228|0.728|||Regression, Logistic|||||0.728|0.228|= 0.0024
71832992|NCT04452318|143170517|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
71832993|NCT04452318|143170518|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
71832994|NCT04452318|143170518|SUPERIORITY||||||=|0.001|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0010
71832995|NCT04452318|143170519|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
71832996|NCT04452318|143170520|SUPERIORITY||Odds Ratio (OR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.208|0.456|||Multiple Imputation, Logistic Regression|||||0.456|0.208|< 0.0001
71832997|NCT04452318|143170522|SUPERIORITY||Odds Ratio (OR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.051|0.286|||Regression, Logistic|||||0.286|0.051|< 0.0001
71832998|NCT04452318|143170523|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
71889967|NCT03575104|143301818|OTHER||LS mean difference to placebo|0.96||||0.5037|TWO_SIDED|95.0|0.84|1.09||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).||1.09|0.84|0.5037
71832999|NCT04452318|143170524|SUPERIORITY||Odds Ratio (OR)|0.09|||=|0.001|TWO_SIDED|95.0|0.02|0.37|||Regression, Logistic|||||0.370|0.020|= 0.0010
71833000|NCT04452318|143170525|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
71774383|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.217|||||TWO_SIDED|95.0|0.961|1.541|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.541|0.961|
71774384|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.066|||||TWO_SIDED|95.0|0.841|1.352|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.352|0.841|
71774385|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.775|||||TWO_SIDED|95.0|0.612|0.981|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.981|0.612|
71833001|NCT04452318|143170528|SUPERIORITY||Difference of LS Means|-2.123|STANDARD_ERROR_OF_MEAN|0.295|<|0.0001|TWO_SIDED|95.0|-2.707|-1.539|||ANOVA|||||-1.539|-2.707|< 0.0001
71833002|NCT04452318|143170529|SUPERIORITY||Difference of LS Means|-2.483|STANDARD_ERROR_OF_MEAN|0.342|<|0.0001|TWO_SIDED|95.0|-3.161|-1.806|||ANOVA|||||-1.806|-3.161|< 0.0001
71833003|NCT04452318|143170530|SUPERIORITY||Difference of LS Mean|-2.428|STANDARD_ERROR_OF_MEAN|0.389|<|0.0001|TWO_SIDED|95.0|-3.196|-1.659|||ANOVA|||||-1.659|-3.196|< 0.0001
71833004|NCT04452318|143170531|SUPERIORITY||Difference of LS Mean|-2.441|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.194|-1.688|||ANOVA|||||-1.688|-3.194|< 0.0001
71833005|NCT04452318|143170534|OTHER||||||=|0.0621|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0621
71833006|NCT04452318|143170535|OTHER||||||=|0.0038|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received'||||= 0.0038
71833007|NCT04452318|143170538|SUPERIORITY||||||<|0.0001|||||||Stratified Wilcoxon Rank Sum Test|||||||< 0.0001
71833008|NCT04452318|143170546|SUPERIORITY||||||=|0.0273|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0273
71833009|NCT04452318|143170547|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.046|TWO_SIDED|95.0|0.299|0.989|||Regression, Logistic|||||0.989|0.299|= 0.0460
71833010|NCT04452318|143170548|SUPERIORITY||Odds Ratio (OR)|0.47|||=|0.0721|TWO_SIDED|95.0|0.207|1.07|||Regression, Logistic|||||1.070|0.207|= 0.0721
71833011|NCT04452318|143170549|SUPERIORITY||||||=|0.026|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0260
71889968|NCT03575104|143301818|OTHER||LS mean difference to placebo|0.81||||0.0021|TWO_SIDED|95.0|0.71|0.93||Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.|Mixed Models Analysis|||Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).||0.93|0.71|0.0021
71833012|NCT04452318|143170550|SUPERIORITY||||||=|0.0614|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0614
71833013|NCT04452318|143170551|SUPERIORITY||LS mean difference|-1.461|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-2.127|-0.795|||ANCOVA|||||-0.795|-2.127|< 0.0001
71833014|NCT04452318|143170552|SUPERIORITY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.279|=|0.0026|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||||-0.300|-1.400|= 0.0026
71833015|NCT04452318|143170553|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|-1.321|-0.559|||ANCOVA|||||-0.559|-1.321|< 0.0001
71833016|NCT04452318|143170554|SUPERIORITY||Difference of LS Mean|-26.045|STANDARD_ERROR_OF_MEAN|6.041|<|0.0001|TWO_SIDED|95.0|-37.973|-14.117|||ANCOVA|||||-14.117|-37.973|< 0.0001
71833017|NCT04452318|143170555|SUPERIORITY||Difference of LS Mean|-1.395|STANDARD_ERROR_OF_MEAN|0.338|<|0.0001|TWO_SIDED|95.0|-2.063|-0.727|||ANCOVA|||||-0.727|-2.063|< 0.0001
71833018|NCT04452318|143170556|SUPERIORITY||||||=|0.0138|||||||Stratified Wilcoxon Rank Sum Test|||||||= 0.0138
71833019|NCT04452318|143170557|OTHER||||||=|0.0292|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.0292
71660357|NCT03056157|142835049|SUPERIORITY||Slope|0.48||||0.92|TWO_SIDED|95.0|-9.6|10.69|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = 0.10, d = 0.01.||10.69|-9.60|0.92
71660358|NCT03056157|142835049|SUPERIORITY||Slope|-16.08|||<|0.001|TWO_SIDED|95.0|-23.64|-8.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.23, d = 1.39.||-8.52|-23.64|<0.001
71660359|NCT03056157|142835049|SUPERIORITY||Slope|-16.56|||<|0.001|TWO_SIDED|95.0|-23.4|-9.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -4.77, d = 1.57.||-9.72|-23.40|<0.001
71660360|NCT03056157|142835049|SUPERIORITY||Slope|-26.28||||0.002|TWO_SIDED|95.0|-42.6|-9.84|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(367) = -3.15, d = 0.33.||-9.84|-42.60|0.002
71660361|NCT03056157|142835049|SUPERIORITY||Slope|-18.72||||0.01|TWO_SIDED|95.0|-32.4|-4.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores for the COVID-19 cohort, t(37) = -2.67, d = 0.28.||-4.92|-32.40|0.01
71660362|NCT03056157|142835049|SUPERIORITY||Slope|-5.25||||0.04|TWO_SIDED|95.0|-10.21|-0.29|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for B- IPF scores, the Pre-Post PCT Time slope was -5.25 \[95% CI = -10.21, -0.29\], p-value = 0.04, t(116) = -2.08, d = 0.39.||-0.29|-10.21|0.04
71660363|NCT03056157|142835050|SUPERIORITY||Slope|-6.38||||0.1|TWO_SIDED|95.0|-13.97|1.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = -1.69, d = 0.48.||1.22|-13.97|0.10
71660364|NCT03056157|142835050|SUPERIORITY||Slope|-13.29|||<|0.001|TWO_SIDED|95.0|-18.96|-7.62|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -4.71, d = 1.67.||-7.62|-18.96|<0.001
71660365|NCT03056157|142835050|SUPERIORITY||Slope|-6.92||||0.001|TWO_SIDED|95.0|-11.96|-1.87|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(32) = -2.75, d = 0.97.||-1.87|-11.96|0.001
71774386|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.912|||||TWO_SIDED|95.0|0.719|1.157|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.157|0.719|
71660366|NCT03056157|142835050|SUPERIORITY||Slope|5.22||||0.34|TWO_SIDED|95.0|-5.6|16.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.97, d = 0.28.||16.05|-5.60|0.34
71660367|NCT03056157|142835050|SUPERIORITY||Slope|5.93||||0.17|TWO_SIDED|95.0|-2.55|14.41|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 1.40, d = 0.40.||14.41|-2.55|0.17
71660368|NCT03056157|142835050|SUPERIORITY||Slope|0.7||||0.83|TWO_SIDED|95.0|-6.04|7.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores for the COVID-19 cohort, t(49) = 0.21, d = 0.06.||7.44|-6.04|0.83
71660369|NCT03056157|142835051|SUPERIORITY||Slope|0.6||||0.76|TWO_SIDED|95.0|-3.12|4.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 0.30, d = 0.03.||4.20|-3.12|0.76
71660370|NCT03056157|142835051|SUPERIORITY||Slope|-3.12||||0.002|TWO_SIDED|95.0|-6.96|-1.56|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.14, d = 1.03.||-1.56|-6.96|0.002
71660371|NCT03056157|142835051|SUPERIORITY||Slope|-4.92|||<|0.001|TWO_SIDED|95.0|-7.32|-2.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(37) = -3.88, d = 1.27.||-2.40|-7.32|<0.001
71660372|NCT03056157|142835051|SUPERIORITY||Slope|-4.8||||0.13|TWO_SIDED|95.0|-11.16|1.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -1.50, d = 0.16.||1.44|-11.16|0.13
71660373|NCT03056157|142835051|SUPERIORITY||Slope|-2.4||||0.38|TWO_SIDED|95.0|-7.68|3.0|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = -0.87, d = 0.09.||3.00|-7.68|0.38
71660374|NCT03056157|142835051|SUPERIORITY||Slope|2.4||||0.26|TWO_SIDED|95.0|-0.96|5.88|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores for the COVID-19 cohort, t(373) = 1.42, d = 0.15.||5.88|-0.96|0.26
71660375|NCT03056157|142835052|SUPERIORITY||Slope|-6.65|||<|0.001|TWO_SIDED|95.0|-10.23|-3.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -3.65, d = 0.39.||-3.07|-10.23|<0.001
71660376|NCT03056157|142835052|SUPERIORITY||Slope|-11.88|||<|0.001|TWO_SIDED|95.0|-14.43|-9.32|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -9.14, d = 1.60.||-9.32|-14.43|<0.001
71660377|NCT03056157|142835052|SUPERIORITY||Slope|-5.23|||<|0.001|TWO_SIDED|95.0|-7.74|-2.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(131) = -4.10, d = 0.72.||-2.72|-7.74|<0.001
71660378|NCT03056157|142835052|SUPERIORITY||Slope|1.36||||0.39|TWO_SIDED|95.0|-1.73|4.45|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.87, d = 0.09.||4.45|-1.73|0.39
71660379|NCT03056157|142835052|SUPERIORITY||Slope|0.08||||0.94|TWO_SIDED|95.0|-2.1|2.26|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = 0.07, d = 0.001.||2.26|-2.10|0.94
71660380|NCT03056157|142835052|SUPERIORITY||Slope|-1.28||||0.25|TWO_SIDED|95.0|-3.48|0.91|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CAPS-5 scores, t(348) = -1.15, d = 0.12.||0.91|-3.48|0.25
71660381|NCT03056157|142835053|SUPERIORITY||Odds Ratio (OR)|6.44||||0.01|TWO_SIDED|95.0|1.29|63.18|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced probable recovery in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||63.18|1.29|0.01
71660382|NCT03056157|142835053|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4|TWO_SIDED|95.0|0.61|3.75|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced improvement in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||3.75|0.61|0.40
71774387|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.876|||||TWO_SIDED|95.0|0.692|1.109|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.109|0.692|
71736902|NCT03831100|142988283|SUPERIORITY||Mean Difference (Net)|-3.4||||0.3|TWO_SIDED|90.0|-8.8|2.0||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores|||2.0|-8.8|0.30
71736903|NCT03831100|142988284|SUPERIORITY||Median Difference (Net)|-9.7||||0.005|TWO_SIDED|90.0|-15.2|-4.2||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-4.2|-15.2|0.005
71736904|NCT03831100|142988285|SUPERIORITY||Mean Difference (Net)|-3.4||||0.064|TWO_SIDED|90.0|-6.4|0.4||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.4|-6.4|0.064
71736905|NCT03831100|142988286|SUPERIORITY||Mean Difference (Net)|-4.3||||0.046|TWO_SIDED|90.0|-7.8|-0.8||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.8|-7.8|0.046
71736906|NCT03831100|142988287|SUPERIORITY||Mean Difference (Net)|-1.5||||0.49|TWO_SIDED|90.0|-5.2|2.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||2.1|-5.2|0.49
71736907|NCT03831100|142988288|SUPERIORITY||Mean Difference (Net)|-3.1||||0.14|TWO_SIDED|90.0|-6.5|0.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||0.3|-6.5|0.14
71774388|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.637|||||TWO_SIDED|95.0|0.504|0.804|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.804|0.504|
71833020|NCT04452318|143170558|OTHER||||||=|0.2466|||||||Fisher Exact|||Testing if there is an association between the observed results and treatment received||||= 0.2466
71660383|NCT03056157|142835053|SUPERIORITY||Odds Ratio (OR)|0.78||||0.58|TWO_SIDED|95.0|0.36|1.7|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced no change in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.70|0.36|0.58
71736908|NCT03831100|142988289|SUPERIORITY||Mean Difference (Net)|3.2||||0.082|TWO_SIDED|90.0|0.2|6.3||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||6.3|0.2|0.082
71736909|NCT03831100|142988290|SUPERIORITY||Mean Difference (Net)|2.7||||0.15|TWO_SIDED|90.0|-0.4|5.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||5.7|-0.4|0.15
71736910|NCT03831100|142988291|SUPERIORITY||Mean Difference (Net)|-2.2||||0.22|TWO_SIDED|90.0|-5.2|-0.7||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.7|-5.2|0.22
71774389|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.75|||||TWO_SIDED|95.0|0.593|0.949|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||0.949|0.593|
71774390|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.727|||||TWO_SIDED|95.0|0.574|0.919|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||0.919|0.574|
71833021|NCT04452318|143170559|SUPERIORITY||||||=|0.7861|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.7861
71736911|NCT03831100|142988292|SUPERIORITY||Mean Difference (Net)|-2.9||||0.093|TWO_SIDED|90.0|-5.8|-0.1||A two-sided P \< .10 indicates the a priori threshold for statistical significance. P-values are not adjusted for multiple comparisons.|ANCOVA||Model-based treatment effect estimated using ANCOVA with change score modeled as a function of treatment group (AC, BRIGHT/Therapist A, BRIGHT/Therapist B), with adjustment for baseline scores.|||-0.1|-5.8|0.093
71736912|NCT01107665|142988312|OTHER||Log Rank HR|0.784||||0.49|TWO_SIDED|95.0|0.41|1.54|||Log Rank|||||1.54|.41|0.49
71736913|NCT01618695|142988325|SUPERIORITY||Median Difference (Final Values)|-5.09||||0.233|TWO_SIDED|95.0|-14.112|4.519|||ANCOVA||Median Difference to placebo and the 95 percent (%) confidence interval are based on the Hodges-Lehmann method.|||4.519|-14.112|0.2330
71736914|NCT01618695|142988325|SUPERIORITY||Median Difference (Final Values)|-16.45||||0.0003|TWO_SIDED|95.0|-25.683|-7.251|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-7.251|-25.683|0.0003
71736915|NCT01618695|142988325|SUPERIORITY||Median Difference (Final Values)|-24.95|||<|0.0001|TWO_SIDED|95.0|-33.878|-16.235|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-16.235|-33.878|<0.0001
71736916|NCT01618695|142988326|SUPERIORITY|||||||0.3954|||||||Cochran-Mantel-Haenszel|||||||0.3954
71736917|NCT01618695|142988326|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
71833022|NCT04452318|143170560|SUPERIORITY||||||=|0.0842|||||||Stratified Wilcoxon Rank Sum test|||||||= 0.0842
71833023|NCT01828554|143170569|OTHER|||||||0.4882||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||The null hypothesis that the AUC from cycle 1 day 1 (based on ideal body weight) is equal to the AUC from cycle 1 day 9 (based on actual body weight) was tested against the alternative hypothesis that the AUCs are not equal. A linear mixed effect model with patient specific random effects was conducted||||0.4882
71833024|NCT01828554|143170570|OTHER|||||||0.7497||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||||||0.7497
71889969|NCT04355013|143301819|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Bland-Altman for repeated measures|-0.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|95.0|-1.1|0.77||||||Arterial outlet-nasopharyngeal temperatures||0.77|-1.10|
71889970|NCT04355013|143301819|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|-0.63|0.95|||Bland-Altman|||Arterial-venous inflow temperatures||0.95|-0.63|
71736918|NCT01618695|142988326|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71736919|NCT01618695|142988327|SUPERIORITY||Median Difference (Final Values)|-8.27||||0.0552|TWO_SIDED|95.0|-18.067|1.671|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||1.671|-18.067|0.0552
71736920|NCT01618695|142988327|SUPERIORITY||Median Difference (Final Values)|-21.21|||<|0.0001|TWO_SIDED|95.0|-30.941|-11.368|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-11.368|-30.941|<0.0001
71736921|NCT01618695|142988327|SUPERIORITY||Median Difference (Final Values)|-28.65|||<|0.0001|TWO_SIDED|95.0|-37.698|-19.794|||ANCOVA||Median Difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|||-19.794|-37.698|<0.0001
71736922|NCT01128192|142988341|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||Two sided P value|ANOVA|||Change in fasting plasma glucose level||||0.240
71736923|NCT01128192|142988341|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma glucose level||||0.339
71736924|NCT01128192|142988342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71736925|NCT01128192|142988342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71736926|NCT01128192|142988342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P Value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71736927|NCT01128192|142988342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71736928|NCT01128192|142988342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71736929|NCT01128192|142988342|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71736930|NCT01128192|142988343|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||0.019
71736931|NCT01128192|142988343|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level||||<0.001
71736932|NCT01128192|142988344|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71736933|NCT01128192|142988344|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71736934|NCT01128192|142988344|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71736935|NCT01128192|142988344|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes||||<0.001
71736936|NCT01128192|142988344|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes||||<0.001
71736937|NCT01128192|142988344|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71736938|NCT01128192|142988345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Baseline Insulin Level||||<0.001
71736939|NCT01128192|142988345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Change in Baseline Insulin Level||||<0.001
71736940|NCT01128192|142988346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
71736941|NCT01128192|142988346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
71736942|NCT01128192|142988346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71736943|NCT01128192|142988346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes||||<0.001
71736944|NCT01128192|142988346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes||||<0.001
71736945|NCT01128192|142988346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes||||<0.001
71736946|NCT01128192|142988347|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.608
71736947|NCT01128192|142988347|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Basal EGP||||0.132
71736948|NCT01128192|142988348|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.178
71736949|NCT01128192|142988348|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition||||0.111
71736950|NCT01128192|142988349|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in high-dose % EGP Inhibition||||0.573
71736951|NCT01128192|142988350|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.956
71736952|NCT01128192|142988350|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)||||0.125
71736953|NCT01128192|142988351|SUPERIORITY_OR_OTHER|||||||0.993|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.993
71736954|NCT01128192|142988351|SUPERIORITY_OR_OTHER|||||||0.956|TWO_SIDED|||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)||||0.956
71736955|NCT03121365|142988362|EQUIVALENCE|0.05||||||0.7635|TWO_SIDED|95.0|||||t-test, 2 sided|||Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.7635
71774391|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.856|||||TWO_SIDED|95.0|0.675|1.084|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint||1.084|0.675|
71774392|NCT00973349|143048906|NON_INFERIORITY_OR_EQUIVALENCE|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.178|||||TWO_SIDED|95.0|0.931|1.489|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.||1.489|0.931|
71833025|NCT03951805|143170573|OTHER||Treatment difference|0.76||||0.7675|TWO_SIDED|95.0|-4.28|5.8|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||5.80|-4.28|0.7675
71736956|NCT03121365|142988362|EQUIVALENCE|0.05||||||0.0996|||||||t-test, 2 sided|||Language Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.0996
71736957|NCT03121365|142988362|EQUIVALENCE|0.05||||||0.2291|||||||t-test, 2 sided|||Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Arms||||.2291
71736958|NCT03121365|142988363|EQUIVALENCE|0.05||||||0.018|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book arm||||.0180
71736959|NCT03121365|142988363|EQUIVALENCE|0.05||||||0.4144|||||||t-test, 2 sided|||StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book arm||||.4144
71736960|NCT03121365|142988363|EQUIVALENCE|0.05||||||0.4251|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm||||.4251
71736961|NCT03121365|142988364|SUPERIORITY|||||||0.235||||||Difference in Board Book Reading|Chi-squared|||||||0.235
71736962|NCT03121365|142988365|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71736963|NCT03121365|142988366|SUPERIORITY|||||||0.601|||||||Chi-squared|||||||0.601
71736964|NCT03121365|142988367|SUPERIORITY|||||||0.219|||||||Chi-squared|||||||0.219
71736965|NCT03121365|142988368|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71736966|NCT03121365|142988369|SUPERIORITY|||||||0.574|||||||Chi-squared|||||||0.574
71736967|NCT03121365|142988370|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.430
71736968|NCT03121365|142988371|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71736969|NCT03121365|142988372|SUPERIORITY|||||||0.861|||||||Chi-squared|||||||0.861
71736970|NCT00746863|142988374|SUPERIORITY_OR_OTHER|||||||0.0251||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0251
71736971|NCT00746863|142988375|SUPERIORITY_OR_OTHER|||||||0.0923||95.0||||Adjusted for multiple comparisions|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.||||0.0923
71736972|NCT00746863|142988376|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Chi-squared|||Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge||||0.4756
71736973|NCT00746863|142988377|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.258
71736974|NCT00746863|142988378|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.||||0.435
71736975|NCT04207749|142988380|NON_INFERIORITY|Noninferiority in CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least Squares Mean Difference|0.01|||||TWO_SIDED|95.0|0.0|0.02||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures||Least squares mean difference (LID015385 minus Biofinity).|||0.02|-0.00|
71833026|NCT03951805|143170573|OTHER||Treatment difference|7.08||||0.0051|TWO_SIDED|95.0|2.12|12.04|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||12.04|2.12|0.0051
71736976|NCT04207749|142988381|NON_INFERIORITY|Proportion of subjects is presented. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||Since noninferiority hypotheses are being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Farrington-Manning||Lens difference (LID015385 minus Biofinity)|||0.04|-0.06|
71736977|NCT01504841|142988390|OTHER||%|36.4|||||TWO_SIDED|95.0|10.9|69.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.|||69.2|10.9|
71736978|NCT01504841|142988390|OTHER||%|100.0|||||TWO_SIDED|95.0|39.8|100.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.|||100|39.8|
71736979|NCT01504841|142988393|OTHER||%|18.2|||||TWO_SIDED|95.0|2.5|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.|||51.8|2.5|
71736980|NCT01504841|142988393|OTHER||%|0.0|||||TWO_SIDED|95.0|0.0|60.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.|||60.2|0|
71736981|NCT01504841|142988394|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||51.8|2.3|
71736982|NCT01504841|142988394|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.||80.6|0.6|
71736983|NCT01504841|142988394|OTHER||%|27.3|||||TWO_SIDED|95.0|6.0|61.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||61|6|
71736984|NCT01504841|142988394|OTHER||%|75.0|||||TWO_SIDED|95.0|19.4|99.4|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.||99.4|19.4|
71736985|NCT01504841|142988398|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||41.3|0.2|
71736986|NCT01504841|142988398|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a \>5% decline in absolute CD4 %.|Week 12 time point.||93.2|6.8|
71736987|NCT01504841|142988398|OTHER||%|9.1|||||TWO_SIDED|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||41.3|0.2|
71736988|NCT01504841|142988398|OTHER||%|25.0|||||TWO_SIDED|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a \>5% decline in absolute CD4 %.|Week 24 time point.||80.6|0.6|
71736989|NCT01504841|142988398|OTHER||%|18.2|||||TWO_SIDED|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||51.8|2.3|
71736990|NCT01504841|142988398|OTHER||%|50.0|||||TWO_SIDED|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a \>5% decline in absolute CD4 %.|Week 48 time point.||93.2|6.8|
71736991|NCT01496469|142988428|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3||||0.882|TWO_SIDED|95.0|-3.9|3.4||Analysis of covariance (ANCOVA) model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|ANCOVA|||A total of 120 enrolled participants (60 participants per treatment group) was sufficient to achieve 80 percent (%) power to detect a difference of 6.0 mmHg between the placebo and febuxostat 80 mg treatment groups by a 2 sample t-test of the mean change from Baseline at Week 6 in 24-hour mean ambulatory SBP with a 2-sided significance level of 5%.||3.4|-3.9|0.882
71736992|NCT01496469|142988429|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6||||0.613|TWO_SIDED|95.0|-1.9|3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||3.2|-1.9|0.613
71736993|NCT01496469|142988430|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-3.9|-2.9||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.||-2.9|-3.9|<0.001
71833027|NCT03951805|143170573|OTHER||Treatment difference|5.01||||0.0519|TWO_SIDED|95.0|-0.04|10.05|||ANCOVA|||The response and change from baseline in response during the last two weeks of treatment (week 15 and 16) are analysed using an analysis of covariance (ANCOVA) model with treatment and SGLT2i use as fixed factors, and baseline response as covariate. Missing endpoint values are imputed using multiple imputation based on own treatment arm with baseline response as a covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.||10.05|-0.04|0.0519
71833028|NCT03684044|143170693|SUPERIORITY||Median Difference (Net)|-2.7||||0.4666|TWO_SIDED|95.0|-53.4|25.9|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||25.9|-53.4|0.4666
71774393|NCT02301988|143048915|SUPERIORITY||Difference in Response Rates|3.77||||0.519||95.0|-8.99|16.54|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||16.54|-8.99|0.519
71774394|NCT02301988|143048916|SUPERIORITY||Difference in response rates|3.29||||0.7817|TWO_SIDED|95.0|-25.52|32.1|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||32.10|-25.52|0.7817
71774395|NCT02301988|143048917|SUPERIORITY||Difference in Response Rates|7.7||||0.2234|TWO_SIDED|95.0|-5.95|21.35|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||21.35|-5.95|0.2234
71736994|NCT01357551|142988448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|0.78||0.04|TWO_SIDED|95.0|0.07|3.13||A priori threshold was p\<.05|Mixed Models Analysis|Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point||The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.||3.13|.07|.04
71736995|NCT01357551|142988449|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.49|STANDARD_ERROR_OF_MEAN|78.64||0.11|TWO_SIDED|95.0|-280.71|29.72|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction||The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.||29.72|-280.71|.11
71736996|NCT01357551|142988450|SUPERIORITY_OR_OTHER||incidence rate ratio|1.03|STANDARD_ERROR_OF_MEAN|0.26||0.91|TWO_SIDED|95.0|0.63|1.68|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.||1.68|0.63|.91
71736997|NCT01357551|142988451|SUPERIORITY_OR_OTHER||incidence rate ratio|1.07|STANDARD_ERROR_OF_MEAN|0.35||0.83|TWO_SIDED|95.0|0.57|2.03|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 \& 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.||2.03|0.57|.83
71736998|NCT02524158|142988487|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.340
71736999|NCT02524158|142988488|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71737000|NCT02524158|142988489|SUPERIORITY|||||||0.005||||||The a priori specified threshold is p \< 0.05|Mixed Models Analysis|||||||0.005
71889971|NCT04355013|143301819|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.62|STANDARD_DEVIATION|0.69|||TWO_SIDED|95.0|-1.98|0.74|||Bland-Altman|||Arterial outlet-bladder||0.74|-1.98|
71889972|NCT04355013|143301819|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.08|STANDARD_DEVIATION|0.74|||TWO_SIDED|95.0|-1.38|1.54|||Bland-Altman|||Arterial outlet- Tcore||1.54|-1.38|
71889973|NCT04355013|143301819|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|0.53|||TWO_SIDED|95.0|-0.73|1.38||||||Nasopharyngeal-venous inflow temperatures||1.38|-0.73|
71737001|NCT02524158|142988490|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71737002|NCT02524158|142988491|SUPERIORITY|||||||0.044||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.044
71737003|NCT02524158|142988492|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
71774396|NCT02301988|143048918|SUPERIORITY||Difference in response rates|-2.96||||0.8169|TWO_SIDED|95.0|-33.91|27.99|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.99|-33.91|0.8169
71774397|NCT02301988|143048919|SUPERIORITY||Difference in response rate|11.11||||0.1607||95.0|-5.64|27.85|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis||27.85|-5.64|0.1607
71774398|NCT02301988|143048920|SUPERIORITY||Difference in Response Rates|23.68||||0.1486|TWO_SIDED|95.0|-13.57|60.94|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis||60.94|-13.57|0.1486
71774399|NCT02301988|143048921|SUPERIORITY||Difference in Response Rates|6.09||||0.498|TWO_SIDED|95.0|-15.01|27.2|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||27.20|-15.01|0.4980
71774400|NCT02301988|143048922|SUPERIORITY||Difference in Response Rates|9.66||||0.3032||95.0|-12.25|31.58|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||31.58|-12.25|0.3032
71774401|NCT02301988|143048924|SUPERIORITY||Difference in Response Rates|4.2||||0.628|TWO_SIDED|95.0|-14.37|22.76|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||22.76|-14.37|0.6280
71774402|NCT02301988|143048925|SUPERIORITY||Difference in Response Rates|8.33||||0.6291|TWO_SIDED|95.0|-33.04|49.71|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.|||49.71|-33.04|0.6291
71774403|NCT02750943|143048929|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-25.34|||<|0.0001|TWO_SIDED|95.0|-30.682|-19.998||From ANCOVA analysis with treatment group, gender and baseline MGI stratification as factors baseline as covariates.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-19.998|-30.682|<0.0001
71774404|NCT02452697|143048963|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.40
71774405|NCT03552965|143048977|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.14, SD=0.378, Range=1, 25th percentile=1, Median=1, 75th percentile=1, n=7 Robust: Mean=1.17, SD=0.577, Range=2, 25th percentile=1, Median=1, 75th percentile=1, n=12"|||
71737004|NCT02524158|142988493|SUPERIORITY|||||||0.01||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.010
71833029|NCT03684044|143170694|SUPERIORITY|||||||0.6326|||||||Cochran-Mantel-Haenszel|Statistic was stratified by region, NEWS2 at baseline (≤7, \>7), and time from symptom onset to study treatment (≤48 hours, \>48 hours)||||||0.6326
71737005|NCT02524158|142988494|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
71737006|NCT02524158|142988495|SUPERIORITY||||||<|0.1|||||||Mixed Models Analysis|||||||<0.10
71737007|NCT02524158|142988496|SUPERIORITY|||||||0.202|||||||ANCOVA|||||||0.202
71737008|NCT02524158|142988497|SUPERIORITY|||||||0.369|||||||ANCOVA|||||||0.369
71737009|NCT02524158|142988498|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
71737010|NCT02524158|142988499|SUPERIORITY|||||||0.067|||||||ANCOVA|||||||0.067
71737011|NCT02524158|142988501|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
71833030|NCT03684044|143170695|SUPERIORITY||Mean Difference (Net)|-6.8||||0.3272|TWO_SIDED|95.0|-50.9|17.7|||Gehan Wilcoxon|The Gehan Wilcoxon test was used to analyze the TTCI data because the proportional hazards assumption was violated||||17.7|-50.9|0.3272
71833031|NCT03703336|143170722|NON_INFERIORITY|If the lower limit of the 95% confidence interval (CI) of the ratio of GMCs between the ROTAVIN and ROTAVIN-M1 groups were to be larger than 1/2, ROTAVIN was considered to be non-inferior to the licensed frozen formulation of the vaccine (ROTAVIN-M1).|GMC Ratio|1.38|||||TWO_SIDED|95.0|1.02|1.86|||||Log10-transformed IgA concentrations were used to construct a 2-sided 95% CI for the mean difference between the arms using t-distribution. The mean difference and 95% CI were exponentiated to obtain the GMC ratio and corresponding 95% CI.|||1.86|1.02|
71833032|NCT03703336|143170724|OTHER||Percentage Difference|6.0|||||TWO_SIDED|95.0|-3.57|15.87||||||||15.87|-3.57|
71737012|NCT02524158|142988502|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
71737013|NCT02524158|142988503|SUPERIORITY|||||||0.036||||||The a priori specified threshold is p \< 0.05|ANCOVA|||||||0.036
71737014|NCT02524158|142988504|SUPERIORITY|||||||0.071|||||||ANCOVA|||||||0.071
71737015|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-1.73|||<|0.0001|TWO_SIDED|95.0|-3.17|-0.29|||ANCOVA|||||-0.29|-3.17|<0.0001
71737016|NCT03100058|142988505|OTHER|Dose finding study|Median Difference (Net)|-1.93|||<|0.0001|TWO_SIDED|95.0|-3.36|-0.5|||ANCOVA|||||-0.50|-3.36|<0.0001
71737017|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.86|-1.75|||ANCOVA|||||-1.75|-4.86|<0.0001
71737018|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-4.42|||<|0.0001|TWO_SIDED|95.0|-5.39|-3.44|||ANCOVA|||||-3.44|-5.39|<0.0001
71737019|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-2.53|-0.25|||ANCOVA|||||-0.25|-2.53|<0.0001
71737020|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-2.74|||<|0.0001|TWO_SIDED|95.0|-4.11|-1.36|||ANCOVA|||||-1.36|-4.11|<0.0001
71737021|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.54|-2.68|||ANCOVA|||||-2.68|-5.54|<0.0001
71737022|NCT03100058|142988505|OTHER|Dose finding study|Mean Difference (Net)|-4.48|||<|0.0001|TWO_SIDED|95.0|-5.54|-3.43|||ANCOVA|||||-3.43|-5.54|<0.0001
71737023|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|2.38||||0.099|TWO_SIDED|95.0|0.85|6.67|||ANCOVA|||\>=5%||6.67|0.85|0.099
71737024|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio, log|1.18||||0.779|TWO_SIDED|95.0|0.36|3.84|||ANCOVA|||\>=5%||3.84|0.36|0.779
71737025|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|3.69||||0.011|TWO_SIDED|95.0|1.35|10.11|||ANCOVA|||\>=5%||10.11|1.35|0.011
71737026|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|5.57|||<|0.001|TWO_SIDED|95.0|2.41|12.88|||ANCOVA|||\>=5%||12.88|2.41|<.001
71737027|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|1.15||||0.812|TWO_SIDED|95.0|0.36|3.74|||ANCOVA|||\>=5%||3.74|0.36|0.812
71737028|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|1.94||||0.229|TWO_SIDED|95.0|0.66|5.69|||ANCOVA|||\>=5%||5.69|0.66|0.229
71737029|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|4.29||||0.004|TWO_SIDED|95.0|1.61|11.46|||ANCOVA|||\>=5%||11.46|1.61|0.004
71737030|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|6.37|||<|0.001|TWO_SIDED|95.0|2.72|14.93|||ANCOVA|||\>=5%||14.93|2.72|<.001
71737031|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|1.09||||0.943|TWO_SIDED|95.0|0.1|12.41|||ANCOVA|||\>=10%||12.41|0.10|0.943
71737032|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|2.11||||0.465|TWO_SIDED|95.0|0.28|15.77|||ANCOVA|||\>=10%||15.77|0.28|0.465
71737033|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|1.6||||0.696|TWO_SIDED|95.0|0.15|17.15|||ANCOVA|||\>=10%||17.15|0.15|0.696
71737034|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|2.14||||0.389|TWO_SIDED|95.0|0.38|12.1|||ANCOVA|||\>=10%||12.10|0.38|0.389
71737035|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|1.04||||0.976|TWO_SIDED|95.0|0.09|11.87|||ANCOVA|||\>=10%||11.87|0.09|0.976
71737036|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|1.02||||0.986|TWO_SIDED|95.0|0.09|11.7|||ANCOVA|||\>=10%||11.70|0.09|0.986
71737037|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|3.51||||0.181|TWO_SIDED|95.0|0.56|22.18|||ANCOVA|||\>=10%||22.18|0.56|0.181
71737038|NCT03100058|142988506|OTHER|Dose finding study|Odds Ratio (OR)|3.97||||0.1|TWO_SIDED|95.0|0.77|20.54|||ANCOVA|||\>=10%||20.54|0.77|0.100
71833033|NCT03703336|143170725|OTHER||Percentage Difference|0.4|||||TWO_SIDED|95.0|-2.4|2.09||||||Percentage Difference on Day 1||2.09|-2.40|
71833034|NCT03703336|143170725|OTHER||Percentage Difference|6.3|||||TWO_SIDED|95.0|-3.19|16.23||||||Percentage Difference on Day 85||16.23|-3.19|
71833035|NCT04629950|143170746|SUPERIORITY|||||||0.395||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||||||0.395
71737039|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|6.29||||0.048|TWO_SIDED|95.0|1.02|38.76|||ANCOVA|||\>=5% (Dysglycemic)||38.76|1.02|0.048
71737040|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio, log|3.94||||0.171|TWO_SIDED|95.0|0.55|28.03|||ANCOVA|||\>=5% (Dsyglycemic)||28.03|0.55|0.171
71737041|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|7.17||||0.041|TWO_SIDED|95.0|1.09|47.27|||ANCOVA|||\>=5% (Dysglycemic)||47.27|1.09|0.041
71737042|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|11.89||||0.003|TWO_SIDED|95.0|2.32|60.93|||ANCOVA|||\>=5% (Dysglycemic)||60.93|2.32|0.003
71737043|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|0.96||||0.976|TWO_SIDED|95.0|0.08|11.72|||ANCOVA|||\>=5% (Dysglycemic)||11.72|0.08|0.976
71737044|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|8.78||||0.022|TWO_SIDED|95.0|1.37|56.44|||ANCOVA|||\>=5% (Dysglycemic)||56.44|1.37|0.022
71737045|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|7.5||||0.032|TWO_SIDED|95.0|1.2|46.99|||ANCOVA|||\>=5% (Dysglycemic)||46.99|1.20|0.032
71737046|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|11.28||||0.005|TWO_SIDED|95.0|2.11|60.46|||ANCOVA|||\>=5% (Dysglycemic)||60.46|2.11|0.005
71737047|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|3.21||||0.227|TWO_SIDED|95.0|0.48|21.28|||ANCOVA|||\>=5% (Normoglycemic)||21.28|0.48|0.227
71737048|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|0.69||||0.763|TWO_SIDED|95.0|0.06|7.85|||ANCOVA|||\>=5% (Normoglycemic)||7.85|0.06|0.763
71737049|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|4.68||||0.095|TWO_SIDED|95.0|0.76|28.7|||ANCOVA|||\>=5% (Normoglycemic)||28.70|0.76|0.095
71774406|NCT03552965|143048978|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.894, Range=2, 25th percentile=1, Median=2, 75th percentile=3, n=6 Robust: Mean=2.91, SD=1.136, Range=3, 25th percentile=2, Median=3, 75th percentile=4, n=11"|||
71774407|NCT03552965|143048979|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2.5, SD=0.577, Range=1, 25th percentile=2, Median=2.5, 75th percentile=3, n=4 Robust: Mean=2.33, SD=1.225, Range=3, 25th percentile=1, Median=2, 75th percentile=3.5, n=9"|||
71774408|NCT03552965|143048980|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=1.83, SD=0.753, Range=2, 25th percentile=1, Median=2, 75th percentile=2.25, n=6 Robust: Mean=2.33, SD=1, Range=3, 25th percentile=1.5, Median=2, 75th percentile=3, n=9"|||
71774409|NCT03552965|143048981|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=2, SD=0.707, Range=2, 25th percentile=1.5, Median=2, 75th percentile=2.5, n=5 Robust: Mean=2.38, SD=1.188, Range=3, 25th percentile=1.25, Median=2, 75th percentile=3.75, n=8"|||
71774410|NCT03552965|143048982|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=15.5, SD=23.76242, Range=75, 25th percentile=0, Median=5, 75th percentile=21.25, n=10 Robust: Mean=14.1346, SD=17.87095, Range=52.5, 25th percentile=0, Median=6.25, 75th percentile=27.5, n=13"|||
71774411|NCT03552965|143048983|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=45.625, SD=30.68744, Range=71.25, 25th percentile=11.25, Median=58.125, 75th percentile=71.25, n=6 Robust: Mean=64.3182, SD=15.0142, Range=48.75, 25th percentile=66.25, Median=70, 75th percentile=71.25, n=11"|||
71774412|NCT03552965|143048984|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=60, SD=23.68412, Range=60, 25th percentile=38.125, Median=68.75, 75th percentile=77.5, n=5 Robust: Mean=54.8611, SD=29.91815, Range=80, 25th percentile=24.375, Median=66.25, 75th percentile=80, n=9"|||
71774413|NCT03552965|143048985|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=31.67, SD=31.38139, Range=85, 25th percentile=5.625, Median=25, 75th percentile=56.875, n=6 Robust: Mean=54.0278, SD=24.57274, Range=67.5, 25th percentile=33.75, Median=62.5, 75th percentile=72.5, n=9"|||
71774414|NCT03552965|143048986|OTHER||||||||||||||||||"Descriptive statistics were used to evaluate the prevalence and grade of xerostomia over time.~Margin-based: Mean=50.75, SD=30.29284, Range=72.5, 25th percentile=21.875, Median=48.75, 75th percentile=80.625, n=5 Robust: Mean=38.4375, SD=26.69897, Range=66.25, 25th percentile=15, Median=29.375, 75th percentile=68.75, n=8"|||
71774415|NCT02477696|143048987|NON_INFERIORITY|Non-inferiority of acalabrutinib was demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) of the hazard ratio was below 1.429.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.79|1.27|||||Cox Proportional Hazards model stratified by 17p deletion status (yes versus no) and number of prior therapies (1-3 versus \>=4).|||1.27|0.79|
71774416|NCT05419908|143048999|SUPERIORITY||LSMean Difference|-12.34|||<|0.001|TWO_SIDED|95.0|-16.89|-7.79||Least square (LS) mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|Analysis of Covariance (ANCOVA)||||-7.79|-16.89|<0.001
71774417|NCT05419908|143049000|SUPERIORITY||LSMean Difference|-1.134|||<|0.001|TWO_SIDED|95.0|-1.466|-0.802||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-0.802|-1.466|<0.001
71774418|NCT05419908|143049000|SUPERIORITY||LSMean Difference|-0.948|||<|0.001||95.0|-1.362|-0.535||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-0.535|-1.362|<0.001
71833036|NCT04629950|143170746|SUPERIORITY|||||||0.41||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.410
71833037|NCT04629950|143170747|SUPERIORITY|||||||0.691|||||||Fisher Exact|||||||0.691
71833038|NCT04629950|143170747|SUPERIORITY|||||||1||||||P values not adjusted for multiple comparisons.|Fisher Exact|||||||1
71833039|NCT04629950|143170748|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|P value not adjusted for multiple comparisons,||||||0.758
71833040|NCT04629950|143170748|SUPERIORITY|||||||0.247||||||P values not adjusted for multiple comparisons.|Fisher Exact|||Data represent change values.||||0.247
71833041|NCT04629950|143170749|SUPERIORITY|||||||0.316||||||P values were not adjusted for multiple comparisons.|t-test, 2 sided|||||||0.316
71833042|NCT04629950|143170749|SUPERIORITY|||||||0.605||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Data represent change values.||||0.605
71833043|NCT04629950|143170750|SUPERIORITY|||||||0.192||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch||||0.192
71737050|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|5.33||||0.033|TWO_SIDED|95.0|1.14|24.83|||ANCOVA|||\>=5% (Normoglycemic)||24.83|1.14|0.033
71737051|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|0.72||||0.788|TWO_SIDED|95.0|0.06|8.1|||ANCOVA|||\>=5% (Normoglycemic)||8.10|0.06|0.788
71737052|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|0.68||||0.751|TWO_SIDED|95.0|0.06|7.62|||ANCOVA|||\>=5% (Normoglycemic)||7.62|0.06|0.751
71737053|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|8.05||||0.027|TWO_SIDED|95.0|1.27|51.09|||ANCOVA|||\>=5% (Normoglycemic)||51.09|1.27|0.027
71737054|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|6.64||||0.023|TWO_SIDED|95.0|1.3|34.0|||ANCOVA|||\>=5% (Normoglycemic)||34.00|1.30|0.023
71737055|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|0.48||||0.528|TWO_SIDED|95.0|0.05|4.78|||ANCOVA|||\>=5% (T2DM)||4.78|0.05|0.528
71737056|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|1.05||||0.958|TWO_SIDED|95.0|0.17|6.68|||ANCOVA|||\>=5% (T2DM)||6.68|0.17|0.958
71737057|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|1.7||||0.546|TWO_SIDED|95.0|0.3|9.49|||ANCOVA|||\>=5% (T2DM)||9.49|0.30|0.546
71737058|NCT03100058|142988507|OTHER|Dose finding test|Odds Ratio (OR)|3.09||||0.098|TWO_SIDED|95.0|0.81|11.75|||ANCOVA|||\>=5% (T2DM)||11.75|0.81|0.098
71737059|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|1.64||||0.563|TWO_SIDED|95.0|0.31|8.7|||ANCOVA|||\>=5% (T2DM)||8.70|0.31|0.563
71737060|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|0.55||||0.61|TWO_SIDED|95.0|0.06|5.38|||ANCOVA|||\>=5% (T2DM)||5.38|0.06|0.610
71737061|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|1.71||||0.528|TWO_SIDED|95.0|0.32|9.16|||ANCOVA|||\>=5% (T2DM)||9.16|0.32|0.528
71737062|NCT03100058|142988507|OTHER|Dose finding study|Odds Ratio (OR)|4.55||||0.023|TWO_SIDED|95.0|1.23|16.9|||ANCOVA|||\>=5% (T2DM)||16.90|1.23|0.023
71737063|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-0.8||||0.47|TWO_SIDED|95.0|-2.96|1.37|||ANCOVA|||||1.37|-2.96|0.470
71737064|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-1.4||||0.199|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|0.199
71737065|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-1.4|||<|0.001|TWO_SIDED|95.0|-3.64|0.76|||ANCOVA|||||0.76|-3.64|<0.001
71737066|NCT03100058|142988508|OTHER|Dose finding study|Mean Difference (Net)|-1.4||||0.206|TWO_SIDED|95.0|-3.56|0.77|||ANCOVA|||||0.77|-3.56|0.206
71737067|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-3.0||||0.006|TWO_SIDED|95.0|-5.18|-0.88|||ANCOVA|||||-0.88|-5.18|0.006
71737068|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-3.5||||0.002|TWO_SIDED|95.0|-5.7|-1.3|||ANCOVA|||||-1.30|-5.70|0.002
71737069|NCT03100058|142988508|OTHER|Dose finding study|Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-5.1|-1.51|||ANCOVA|||||-1.51|-5.10|<0.001
71737070|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-0.9||||0.391|TWO_SIDED|95.0|-2.82|1.1|||ANCOVA|||||1.10|-2.82|0.391
71737071|NCT03100058|142988508|OTHER|Dose finding study|Median Difference (Net)|-2.5||||0.259|TWO_SIDED|95.0|-3.1|0.84|||ANCOVA|||||0.84|-3.10|0.259
71737072|NCT03100058|142988508|OTHER|Dose finding study|Mean Difference (Net)|-2.5||||0.048|TWO_SIDED|95.0|-4.91|-0.02|||ANCOVA|||||-0.02|-4.91|0.048
71737073|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|1.0||||0.225|TWO_SIDED|95.0|-0.62|2.61|||ANCOVA|||||2.61|-0.62|0.225
71737074|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|-1.0||||0.247|TWO_SIDED|95.0|-2.62|0.68|||ANCOVA|||||0.68|-2.62|0.247
71737075|NCT03100058|142988509|OTHER|Dose finding study|Median Difference (Net)|-2.0||||0.019|TWO_SIDED|95.0|-3.75|-0.34|||ANCOVA|||||-0.34|-3.75|0.019
71737076|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.015|TWO_SIDED|95.0|-2.96|-0.33|||ANCOVA|||||-0.33|-2.96|0.015
71737077|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|-1.3||||0.106|TWO_SIDED|95.0|-2.97|0.29|||ANCOVA|||||0.29|-2.97|0.106
71737078|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.02|TWO_SIDED|95.0|-3.54|-0.31|||ANCOVA|||||-0.31|-3.54|0.020
71737079|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.035|TWO_SIDED|95.0|-3.44|-0.12|||ANCOVA|||||-0.12|-3.44|0.035
71737080|NCT03100058|142988509|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.004|TWO_SIDED|95.0|-3.22|-0.61|||ANCOVA|||||-0.61|-3.22|0.004
71737081|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.082|TWO_SIDED|95.0|-0.05|0.79|||ANCOVA|||||0.79|-0.05|0.082
71737082|NCT03100058|142988510|OTHER|Dose finding study|Median Difference (Net)|-0.2||||0.319|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|0.319
71737083|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.008|TWO_SIDED|95.0|-1.05|-0.16|||ANCOVA|||||-0.16|-1.05|0.008
71737084|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.015|TWO_SIDED|95.0|-0.76|-0.08|||ANCOVA|||||-0.08|-0.76|0.015
71737085|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|-0.1||||0.707|TWO_SIDED|95.0|-0.5|0.34|||ANCOVA|||||0.34|-0.50|0.707
71737086|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.28|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||||0.19|-0.65|0.280
71737087|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.086|TWO_SIDED|95.0|-0.8|0.05|||ANCOVA|||||0.05|-0.80|0.086
71833044|NCT04629950|143170750|SUPERIORITY|||||||0.392||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Average Itch. Data represent change values.||||0.392
71833045|NCT04629950|143170750|SUPERIORITY|||||||0.347||||||P values not adjusted for multiple comparisons.|t-test, 2 sided|||Mean Reduction in Maximum Itch||||0.347
71833046|NCT04629950|143170750|SUPERIORITY|||||||0.572||||||P value not adjusted for multiple comparisons,|t-test, 2 sided|||Mean Reduction in Maximum Itch. Data represent change values.||||0.572
71737088|NCT03100058|142988510|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.03|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||||-0.04|-0.72|0.030
71737089|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.156|TWO_SIDED|95.0|-6.64|1.07|||ANCOVA|||SBP||1.07|-6.64|0.156
71737090|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-3.1||||0.127|TWO_SIDED|95.0|-7.11|0.89|||ANCOVA|||SBP||0.89|-7.11|0.127
71737091|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-6.5||||0.002|TWO_SIDED|95.0|-10.52|-2.42|||ANCOVA|||SBP||-2.42|-10.52|0.002
71737092|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.089|TWO_SIDED|95.0|-5.86|0.42|||ANCOVA|||SBP||0.42|-5.86|0.089
71737093|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.245|TWO_SIDED|95.0|-6.12|1.57|||ANCOVA|||SBP||1.57|-6.12|0.245
71737094|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-0.8||||0.678|TWO_SIDED|95.0|-4.65|3.02|||ANCOVA|||SBP||3.02|-4.65|0.678
71737095|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-4.1||||0.04|TWO_SIDED|95.0|-8.07|-0.19|||ANCOVA|||SBP||-0.19|-8.07|0.040
71737096|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-3.4||||0.038|TWO_SIDED|95.0|-6.61|-0.19|||ANCOVA|||SBP||-0.19|-6.61|0.038
71737097|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-0.7||||0.601|TWO_SIDED|95.0|-3.38|1.96|||ANCOVA|||DBP||1.96|-3.38|0.601
71737098|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-0.4||||0.76|TWO_SIDED|95.0|-3.2|2.34|||ANCOVA|||DBP||2.34|-3.20|0.760
71737099|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-2.8||||0.051|TWO_SIDED|95.0|-5.6|0.01|||ANCOVA|||DBP||0.01|-5.60|0.051
71737100|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-1.8||||0.105|TWO_SIDED|95.0|-3.98|0.38|||ANCOVA|||DBP||0.38|-3.98|0.105
71737101|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|0.3||||0.82|TWO_SIDED|95.0|-2.36|2.98|||ANCOVA|||DBP||2.98|-2.36|0.820
71737102|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-1.9||||0.157|TWO_SIDED|95.0|-4.58|0.74|||ANCOVA|||DBP||0.74|-4.58|0.157
71737103|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-0.2||||0.859|TWO_SIDED|95.0|-2.99|2.49|||ANCOVA|||DBP||2.49|-2.99|0.859
71737104|NCT03100058|142988511|OTHER|Dose finding study|Mean Difference (Net)|-2.2||||0.054|TWO_SIDED|95.0|-4.41|0.04|||ANCOVA|||DBP||0.04|-4.41|0.054
71737105|NCT03100058|142988513|OTHER|Dose finding study|Median Difference (Net)|-0.6||||0.355|TWO_SIDED|95.0|-1.84|0.66|||ANCOVA|||||0.66|-1.84|0.355
71737106|NCT03100058|142988513|OTHER|Dose finding study|Mean Difference (Net)|-0.6||||0.373|TWO_SIDED|95.0|-1.83|0.69|||ANCOVA|||||0.69|-1.83|0.373
71737107|NCT03100058|142988513|OTHER|Dose finding study|Mean Difference (Net)|-2.8|||<|0.001|TWO_SIDED|95.0|-4.36|-1.24|||ANCOVA|||||-1.24|-4.36|<0.001
71737108|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.632|TWO_SIDED|95.0|0.81|1.42|||ANCOVA|||||1.42|0.81|0.632
71737109|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.15||||0.352|TWO_SIDED|95.0|0.86|1.55|||ANCOVA|||||1.55|0.86|0.352
71737110|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.41||||0.027|TWO_SIDED|95.0|1.04|1.92|||ANCOVA|||||1.92|1.04|0.027
71737111|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.07||||0.587|TWO_SIDED|95.0|0.85|1.35|||ANCOVA|||||1.35|0.85|0.587
71737112|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.1||||0.508|TWO_SIDED|95.0|0.82|1.47|||ANCOVA|||||1.47|0.82|0.508
71737113|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.01||||0.945|TWO_SIDED|95.0|0.76|1.34|||ANCOVA|||||1.34|0.76|0.945
71737114|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.08||||0.602|TWO_SIDED|95.0|0.81|1.45|||ANCOVA|||||1.45|0.81|0.602
71737115|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|1.06||||0.612|TWO_SIDED|95.0|0.84|1.35|||ANCOVA|||||1.35|0.84|0.612
71737116|NCT03100058|142988519|OTHER|Dose finding study|Median Difference (Net)|0.89||||0.382|TWO_SIDED|95.0|0.68|1.16|||ANCOVA|||||1.16|0.68|0.382
71737117|NCT03100058|142988519|OTHER|Dose finding study|Median Difference (Net)|0.87||||0.31|TWO_SIDED|95.0|0.67|1.14|||ANCOVA|||||1.14|0.67|0.310
71737118|NCT03100058|142988519|OTHER|Dose finding study|Mean Difference (Net)|0.9||||0.525|TWO_SIDED|95.0|0.65|1.25|||ANCOVA|||||1.25|0.65|0.525
71737119|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-7.9||||0.254|TWO_SIDED|95.0|-21.37|5.65|||ANCOVA|||Triglycerides (TG)||5.65|-21.37|0.254
71737120|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-2.7||||0.716|TWO_SIDED|95.0|-17.44|11.99|||ANCOVA|||Triglycerides (TG)||11.99|-17.44|0.716
71737121|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-15.6||||0.038|TWO_SIDED|95.0|-30.3|-0.86|||ANCOVA|||Triglycerides (TG)||-0.86|-30.30|0.038
71737122|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-7.0||||0.213|TWO_SIDED|95.0|-18.15|4.06|||ANCOVA|||Triglycerides (TG)||4.06|-18.15|0.213
71737123|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-1.7||||0.806|TWO_SIDED|95.0|-15.38|11.96|||ANCOVA|||Triglycerides (TG)||11.96|-15.38|0.806
71737124|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-2.3||||0.739|TWO_SIDED|95.0|-15.8|11.21|||ANCOVA|||Triglycerides (TG)||11.21|-15.80|0.739
71737125|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|1.4||||0.837|TWO_SIDED|95.0|-12.36|15.26|||ANCOVA|||Triglycerides (TG)||15.26|-12.36|0.837
71737126|NCT03100058|142988520|OTHER||Mean Difference (Net)|-11.4||||0.049|TWO_SIDED|95.0|-22.71|-0.07|||ANCOVA|||Triglycerides (TG)||-0.07|-22.71|0.049
71737127|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|1.3||||0.764|TWO_SIDED|95.0|-7.22|9.82|||ANCOVA|||Total Cholesterol (TC)||9.82|-7.22|0.764
71737128|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|2.6||||0.571|TWO_SIDED|95.0|-6.43|11.63|||ANCOVA|||Total Cholesterol (TC)||11.63|-6.43|0.571
71737129|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|0.1||||0.987|TWO_SIDED|95.0|-9.3|9.46|||ANCOVA|||Total Cholesterol (TC)||9.46|-9.30|0.987
71833047|NCT04629950|143170751|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
71737130|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|9.9||||0.006|TWO_SIDED|95.0|2.85|16.87|||ANCOVA|||Total Cholesterol (TC)||16.87|2.85|0.006
71737131|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-3.3||||0.463|TWO_SIDED|95.0|-12.03|5.48|||ANCOVA|||Total Cholesterol (TC)||5.48|-12.03|0.463
71737132|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|0.4||||0.925|TWO_SIDED|95.0|-8.18|9.01|||ANOVA|||Total Cholesterol (TC)||9.01|-8.18|0.925
71737133|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.711|TWO_SIDED|95.0|-7.19|10.53|||ANCOVA|||Total Cholesterol (TC)||10.53|-7.19|0.711
71737134|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.265|TWO_SIDED|95.0|-3.1|11.26|||ANCOVA|||Total Cholesterol (TC)||11.26|-3.10|0.265
71833048|NCT04629950|143170752|OTHER|||||||0.141|||||||Wilcoxon (Mann-Whitney)|||||||0.141
71889974|NCT04355013|143301819|OTHER|Agreement between different methods of temperature measurement (Bland-Altman plot with multiple measurements per individual).|Mean Difference (Final Values)|-0.46|STANDARD_DEVIATION|0.52|||TWO_SIDED|95.0|-1.5|0.59||||||Nasopharyngeal-bladder temperatures||0.59|-1.50|
71889975|NCT04355013|143301819|OTHER|Bland-Altman for repeated measures|Bland-Altman for repeated measures|0.24|STANDARD_DEVIATION|0.58|||TWO_SIDED|95.0|-0.9|1.39||||||Nasopharyngeal-Tcore temperatures||1.39|-0.90|
71737135|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|0.0||||0.995|TWO_SIDED|95.0|-7.31|7.36|||ANCOVA|||HDL Cholesterol||7.36|-7.31|0.995
71737136|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|4.1||||0.288|TWO_SIDED|95.0|-3.52|11.81|||ANCOVA|||HDL Cholesterol||11.81|-3.52|0.288
71737137|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|4.5||||0.269|TWO_SIDED|95.0|-3.5|12.5|||ANCOVA|||HDL Cholesterol||12.50|-3.50|0.269
71737138|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|7.3||||0.018|TWO_SIDED|95.0|1.23|13.27|||ANCOVA|||HDL Cholesterol||13.27|1.23|0.018
71737139|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|2.2||||0.565|TWO_SIDED|95.0|-5.32|9.73|||ANCOVA|||HDL Cholesterol||9.73|-5.32|0.565
71737140|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|1.7||||0.649|TWO_SIDED|95.0|-5.67|9.09|||ANCOVA|||HDL Cholesterol||9.09|-5.67|0.649
71737141|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|0.7||||0.847|TWO_SIDED|95.0|-6.87|8.36|||ANCOVA|||HDL Cholesterol||8.36|-6.87|0.847
71737142|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|7.3||||0.02|TWO_SIDED|95.0|1.14|13.43|||ANCOVA|||HDL Cholesterol||13.43|1.14|0.020
71737143|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.579|TWO_SIDED|95.0|-17.09|9.57|||ANCOVA|||LDL Cholesterol||9.57|-17.09|0.579
71737144|NCT03100058|142988520|OTHER||Mean Difference (Net)|5.0||||0.487|TWO_SIDED|95.0|-9.08|19.02|||ANCOVA|||LDL Cholesterol||19.02|-9.08|0.487
71737145|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-4.3||||0.561|TWO_SIDED|95.0|-18.96|10.3|||ANCOVA|||LDL Cholesterol||10.30|-18.96|0.561
71737146|NCT03100058|142988520|OTHER||Mean Difference (Net)|9.3||||0.097|TWO_SIDED|95.0|-1.68|20.25|||ANCOVA|||LDL Cholesterol||20.25|-1.68|0.097
71737147|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-8.4||||0.227|TWO_SIDED|95.0|-22.1|5.26|||ANCOVA|||LDL Cholesterol||5.26|-22.10|0.227
71737148|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-3.8||||0.58|TWO_SIDED|95.0|-17.22|9.64|||ANCOVA|||LDL Cholesterol||9.64|-17.22|0.580
71737149|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-4.8||||0.494|TWO_SIDED|95.0|-18.67|9.03|||ANCOVA|||LDL Cholesterol||9.03|-18.67|0.494
71737150|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|-1.6||||0.782|TWO_SIDED|95.0|-12.81|9.65|||ANCOVA|||LDL Cholesterol||9.65|-12.81|0.782
71737151|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|1.9||||0.816|TWO_SIDED|95.0|-13.82|17.54|||ANCOVA|||Triglycerides (TG)||17.54|-13.82|0.816
71737152|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|8.02||||0.341|TWO_SIDED|95.0|-8.13|23.42|||ANCOVA|||Triglycerides (TG)||23.42|-8.13|0.341
71889976|NCT00331006|143301823|SUPERIORITY_OR_OTHER||Proportion|0.1875||||0.043|ONE_SIDED|95.0|0.053|||the a priori p-value was 0.05 for statistical significance|Exact Binomial|||The null hypothesis is that the proportion of participants in which the inhibitor level falls to less than 5 BU/mL between weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with factor VIII is no more than 0.05|||.053|0.043
71889977|NCT00331006|143301824|SUPERIORITY_OR_OTHER||Proportion|0.25|||||TWO_SIDED|95.0|0.073|0.524|||Exact Binomial|||No hypothesis about the value of this proportion was specified in the study design||0.524|0.073|
71889978|NCT01147926|143301847|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71737153|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|9.99||||0.566|TWO_SIDED|95.0|-25.39|13.91|||ANCOVA|||Triglycerides (TG)||13.91|-25.39|0.566
71737154|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|2.98||||0.405|TWO_SIDED|95.0|-3.38|8.36|||ANCOVA|||Total Cholesterol (TC)||8.36|-3.38|0.405
71737155|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|2.0||||0.511|TWO_SIDED|95.0|-3.92|7.87|||ANCOVA|||Total Cholesterol (TC)||7.87|-3.92|0.511
71737156|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|2.5||||0.506|TWO_SIDED|95.0|-4.83|9.79|||ANCOVA|||Total Cholesterol (TC)||9.79|-4.83|0.506
71737157|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|3.3||||0.392|TWO_SIDED|95.0|-4.2|10.7|||ANCOVA|||HDL Cholesterol||10.70|-4.20|0.392
71833049|NCT04629950|143170753|OTHER|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||||||0.582
71833050|NCT04629950|143170754|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
71833051|NCT04629950|143170755|OTHER|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
71833052|NCT04629950|143170756|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
71833053|NCT04629950|143170757|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||0.221
71737158|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|3.0||||0.426|TWO_SIDED|95.0|-4.45|10.53|||ANOVA|||HDL Cholesterol||10.53|-4.45|0.426
71737159|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|8.5||||0.071|TWO_SIDED|95.0|-0.72|17.8|||ANCOVA|||HDL Cholesterol||17.80|-0.72|0.071
71737160|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|2.9||||0.498|TWO_SIDED|95.0|-5.56|11.42|||ANCOVA|||LDL Cholesterol||11.42|-5.56|0.498
71737161|NCT03100058|142988520|OTHER|Dose finding study|Median Difference (Net)|2.4||||0.586|TWO_SIDED|95.0|-6.17|10.9|||ANCOVA|||LDL Cholesterol||10.90|-6.17|0.586
71737162|NCT03100058|142988520|OTHER|Dose finding study|Mean Difference (Net)|2.1||||0.696|TWO_SIDED|95.0|-8.47|12.67|||ANCOVA|||LDL Cholesterol||12.67|-8.47|0.696
71737163|NCT04569357|142988578|SUPERIORITY|||||||0.0199|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 25%.||||0.0199
71737164|NCT04569357|142988579|SUPERIORITY|||||||0.0096|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores after 8 weeks of treatment were compared.||||0.0096
71737165|NCT04569357|142988580|SUPERIORITY|||||||0.0063|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (attention deficit subscale) after 8 weeks of treatment were compared.||||0.0063
71737166|NCT04569357|142988581|SUPERIORITY|||||||0.0525|||||||Wilcoxon (Mann-Whitney)|||Mean changes of ADHD-RS-V scores (hyperactivity/impulsivity subscale) after 8 weeks of treatment were compared.||||0.0525
71737167|NCT04569357|142988582|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect analysis.||||0.0024
71737168|NCT04569357|142988582|SUPERIORITY|||||||0.1722|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.1722
71833054|NCT04629950|143170757|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||0.286
71737169|NCT04569357|142988582|SUPERIORITY|||||||0.0012|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.0012
71833055|NCT04629950|143170758|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis for Average Itch Over the Preceding 3 Days||||1
71737170|NCT04569357|142988583|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
71737171|NCT04569357|142988584|SUPERIORITY|||||||0.81||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Systolic pressure data.||||0.81
71737172|NCT04569357|142988584|SUPERIORITY|||||||0.22||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to Diastolic pressure data.||||0.22
71737173|NCT04569357|142988585|SUPERIORITY|||||||0.13||||||"The p-value associated with treatment\*visit interaction of changes from baseline visit 1 to visit 2 and 3 endpoint between Prospekta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.13
71737174|NCT04569357|142988586|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.2
71737175|NCT04569357|142988587|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71737176|NCT04569357|142988588|SUPERIORITY|||||||0.5|||||||Fisher Exact|||||||0.5
71737177|NCT04569357|142988589|SUPERIORITY|||||||0.0254|||||||Fisher Exact|||||||0.0254
71737178|NCT01853878|142988600|EQUIVALENCE|P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)|Hazard Ratio (HR)|4.592||||0.1422|TWO_SIDED|95.0|0.6|35.167|||Regression, Cox|||Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment \[Chemotherapy (CT) vs. no-CT\] and disease stage.||35.167|0.600|0.1422
71737179|NCT02161757|142988610|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.93||||0.5859|TWO_SIDED|95.0|0.72|1.21|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.||1.21|0.72|0.5859
71737180|NCT02161757|142988610|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.9||||0.4406|TWO_SIDED|95.0|0.7|1.17|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.||1.17|0.70|0.4406
71737181|NCT02161757|142988610|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|7.01||||0.5859|TWO_SIDED|95.0|-20.76|28.39|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.||28.39|-20.76|0.5859
71833056|NCT04629950|143170758|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Analysis is for the Maximum Itch of the Preceding 7 Days||||1
71833057|NCT02088853|143170765|SUPERIORITY|Wilcoxon test|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71833058|NCT02088853|143170766|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71833059|NCT02088853|143170767|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71833060|NCT01198145|143170771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71833061|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Chi-squared|||Comparing Tenesmus During RT||||0.23
71737182|NCT02161757|142988610|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|9.76||||0.4406|TWO_SIDED|95.0|-17.16|30.5|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.||30.50|-17.16|0.4406
71833062|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Chi-squared|||Comparing Tenesmus after RT||||0.64
71737183|NCT02161757|142988611|SUPERIORITY||Least square (LS) Mean difference|6.03|||||TWO_SIDED|95.0|2.34|9.73|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||9.73|2.34|
71737184|NCT02161757|142988611|SUPERIORITY||LS Mean difference|2.1|||||TWO_SIDED|95.0|-1.58|5.77|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."||5.77|-1.58|
71737185|NCT02161757|142988612|SUPERIORITY||LS Mean difference|-0.09|||||TWO_SIDED|95.0|-0.23|0.04|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.04|-0.23|
71737186|NCT02161757|142988612|SUPERIORITY||LS Mean difference|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.12|-0.15|
71737187|NCT02161757|142988613|SUPERIORITY||LS Mean difference|0.15|||||TWO_SIDED|95.0|-0.01|0.31|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||0.31|-0.01|
71737188|NCT02161757|142988613|SUPERIORITY||LS Mean difference|0.12|||||TWO_SIDED|95.0|-0.03|0.28|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.28|-0.03|
71737189|NCT02161757|142988614|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.29|-0.02|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||-0.02|-0.29|
71737190|NCT02161757|142988614|SUPERIORITY||LS Mean difference|-0.12|||||TWO_SIDED|95.0|-0.26|0.01|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||0.01|-0.26|
71737191|NCT02161757|142988615|SUPERIORITY||Rate ratio|0.54||||0.0369|TWO_SIDED|95.0|0.3|0.96|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.||0.96|0.30|0.0369
71833063|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Chi-squared|||Comparing abdominal pain during RT.||||0.30
71833064|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||Comparing abdominal pain after RT||||0.02
71889979|NCT03417440|143301866|SUPERIORITY||Estimated mean change|-898.0||||0.37|TWO_SIDED|95.0|-2884.82|1088.82||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||1088.82|-2884.82|.37
71737192|NCT02161757|142988615|SUPERIORITY||Rate ratio|0.78||||0.3603|TWO_SIDED|95.0|0.46|1.33|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.||1.33|0.46|0.3603
71833065|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||Comparing constipation during RT||||0.70
71833066|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Chi-squared|||Comparing constipation after RT||||0.63
71833067|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Chi-squared|||Comparing diarrhea during RT||||0.44
71833068|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|||||||Chi-squared|||Comparing diarrhea after RT||||0.48
71833069|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||Chi-squared|||Comparing rectal bleeding during RT||||0.38
71833070|NCT01198145|143170772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Chi-squared|||||||0.15
71890296|NCT03952559|143302133|SUPERIORITY||LS Mean difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|1.813||0.8611|TWO_SIDED|95.0|-3.24|3.88|||Mixed Models Analysis|||for 8 to \<18 years old||3.88|-3.24|0.8611
71737193|NCT02161757|142988617|SUPERIORITY||LS Mean difference|-0.11|||||TWO_SIDED|95.0|-0.51|0.29|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.51|
71737194|NCT02161757|142988617|SUPERIORITY||LS Mean difference|-0.16|||||TWO_SIDED|95.0|-0.56|0.24|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.||0.24|-0.56|
71737195|NCT02161757|142988618|SUPERIORITY||LS Mean difference|6.25|||||TWO_SIDED|95.0|-3.53|16.03|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.03|-3.53|
71737196|NCT02161757|142988618|SUPERIORITY||LS Mean difference|1.77|||||TWO_SIDED|95.0|-7.99|11.53|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||11.53|-7.99|
71774419|NCT05419908|143049000|SUPERIORITY||LSMean Difference|-1.122|||<|0.001|TWO_SIDED|95.0|-1.504|-0.741||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-0.741|-1.504|<0.001
71737197|NCT02161757|142988618|SUPERIORITY||LS Mean difference|7.14|||||TWO_SIDED|95.0|-2.6|16.87|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||16.87|-2.60|
71737198|NCT02161757|142988618|SUPERIORITY||LS Mean difference|0.61|||||TWO_SIDED|95.0|-9.13|10.35|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||10.35|-9.13|
71737199|NCT02161757|142988619|SUPERIORITY||LS Mean difference|-1.8|||||TWO_SIDED|95.0|-5.29|1.69|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."||1.69|-5.29|
71737200|NCT02161757|142988619|SUPERIORITY||LS Mean difference|-2.36|||||TWO_SIDED|95.0|-5.84|1.12|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."||1.12|-5.84|
71737201|NCT02161757|142988620|SUPERIORITY||Odds Ratio (OR)|0.95||||0.732|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.||1.28|0.71|0.732
71774420|NCT05419908|143049001|SUPERIORITY||LSMean Difference|-13.28|||<|0.001||95.0|-17.02|-9.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-9.54|-17.02|<0.001
71833071|NCT01198145|143170773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II during RT.||||0.56
71833072|NCT01198145|143170773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II after RT.||||0.74
71889980|NCT03417440|143301866|SUPERIORITY||Estimated mean change|-2602.1||||0.02|TWO_SIDED|95.0|-4687.44|-516.69||A single model was run including variables indicating Proof Positive (yes/no), Coach Me (yes/no), and On Your Feet (yes/no) and their interaction terms.|Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||-516.69|-4687.44|.02
71660384|NCT03056157|142835053|SUPERIORITY||Odds Ratio (OR)|0.15||||0.06|TWO_SIDED|95.0|0.003|1.2|||Fisher Exact|||Odds ratio comparison of the proportions of participants who experienced deterioration in CAPS-5 from baseline to post-treatment in AD-MIL versus PCT.||1.20|0.003|0.06
71774421|NCT05419908|143049001|SUPERIORITY||LSMean Difference|-11.78|||<|0.001|TWO_SIDED|95.0|-16.3|-7.27||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-7.27|-16.30|<0.001
71833073|NCT00891436|143170780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||paired t-test was used for the data analysis||||>0.1
71833074|NCT00891436|143170780|NON_INFERIORITY_OR_EQUIVALENCE|t-test showed no different between the 2 groups.|Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.5|>|0.1||95.0|||||t-test, 2 sided|||||||>0.1
71833075|NCT01381406|143170788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.772||||0.007|TWO_SIDED|95.0|0.641|0.93||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Any COPD Exacerbation|Regression, Logistic|||||0.930|0.641|0.007
71660385|NCT03056157|142835054|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.22|1.06|||Fisher Exact|||Odds ratio comparison of the proportions of participants with a PTSD Diagnosis in CAPS-5 at post-treatment in AD-MIL versus PCT.||1.06|0.22|0.07
71660386|NCT03056157|142835054|SUPERIORITY||Odds Ratio (OR)|0.66||||0.33|TWO_SIDED|95.0|0.28|1.56|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 3MFU in AD-MIL versus PCT.||1.56|0.28|0.33
71737202|NCT02161757|142988620|SUPERIORITY||Odds Ratio (OR)|0.88||||0.421|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.||1.19|0.65|0.421
71737203|NCT01399866|142988629|SUPERIORITY|||||||0.574|||||||ANOVA|||||||0.574
71737204|NCT01399866|142988629|SUPERIORITY|||||||0.747|||||||ANOVA|||||||0.747
71737205|NCT01399866|142988630|SUPERIORITY|||||||0.94|||||||ANOVA|||||||0.94
71737206|NCT01399866|142988631|SUPERIORITY|||||||0.818|||||||ANOVA|||||||0.818
71737207|NCT01399866|142988632|SUPERIORITY|||||||0.123|||||||ANOVA|||||||0.123
71737208|NCT01399866|142988633|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||||||0.473
71737209|NCT03916081|142988641|SUPERIORITY||LS Mean Difference vs Vehicle|-1.18||||0.356|TWO_SIDED|95.0|-2.983|0.619||MMRM = mixed effects model for repeated measures vIGA-AD = validated Investigator Global Assessment scale for Atopic Dermatitis|MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.619|-2.983|0.356
71737210|NCT03916081|142988641|SUPERIORITY||LS Mean Difference vs Vehicle|-1.6||||0.097|TWO_SIDED|95.0|-3.382|0.178|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.178|-3.382|0.097
71737211|NCT03916081|142988642|SUPERIORITY||LS Mean Difference|-11.37||||0.248|TWO_SIDED|95.0|-26.789|4.044|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||4.044|-26.789|0.248
71737212|NCT03916081|142988642|SUPERIORITY||LS Mean Difference|-10.28||||0.349|TWO_SIDED|95.0|-25.666|5.114|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||5.114|-25.666|0.349
71737213|NCT03916081|142988642|SUPERIORITY||LS Mean Difference|-5.82||||0.912|TWO_SIDED|-22.52|-22.52|10.88|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||10.880|-22.520|0.912
71737214|NCT03916081|142988642|SUPERIORITY||LS Mean Difference|-9.17||||0.548|TWO_SIDED|95.0|-25.686|7.341|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 2 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||7.341|-25.686|0.548
71774422|NCT05419908|143049001|SUPERIORITY||LSMean Difference|-12.42|||<|0.001||95.0|-17.0|-7.83||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hot flash score as covariate. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-7.83|-17.00|<0.001
71774423|NCT05419908|143049002|SUPERIORITY||LSMean Difference|-39.8|||<|0.001|TWO_SIDED|95.0|-50.5|-29.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 4||-29.1|-50.5|<0.001
71889981|NCT03417440|143301866|SUPERIORITY||Estimated mean change|-1244.9||||0.23|TWO_SIDED|95.0|-3287.6|797.85|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||797.85|-3287.60|.23
71660387|NCT03056157|142835054|SUPERIORITY||Odds Ratio (OR)|0.42||||0.05|TWO_SIDED|95.0|0.15|1.08|||Fisher Exact|||Odds ratio comparison of the proportions of participants with PTSD Diagnosis in CAPS-5 at 6MFU in AD-MIL versus PCT.||1.08|0.15|0.05
71660388|NCT03056157|142835055|SUPERIORITY||Slope|-4.63||||0.003|TWO_SIDED|95.0|-7.16|-2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -3.01, d = 0.13.||-2.10|-7.16|.003
71774424|NCT05419908|143049002|SUPERIORITY||LSMean Difference|-35.5|||<|0.001|TWO_SIDED|95.0|-47.9|-23.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 8||-23.0|-47.9|<0.001
71660389|NCT03056157|142835055|SUPERIORITY||Slope|-12.62|||<|0.001|TWO_SIDED|95.0|-14.43|-10.8|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -11.50, d = 1.81.||-10.80|-14.43|<0.001
71660390|NCT03056157|142835055|SUPERIORITY||Slope|-7.89|||<|0.001|TWO_SIDED|95.0|-9.77|-6.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(161) = -7.40, d = 1.16.||-6.20|-9.77|<0.001
71660391|NCT03056157|142835055|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-4.01|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = -0.45, d = 0.02.||2.52|-4.01|0.65
71774425|NCT05419908|143049002|SUPERIORITY||LSMean Difference|-35.0|||<|0.001||95.0|-47.9|-22.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as factor. P-value of the t-statistic testing whether there is a treatment difference.|ANCOVA|||Week 12||-22.1|-47.9|<0.001
71774426|NCT05419908|143049003|SUPERIORITY||Percentage Difference|65.1|||<|0.001|TWO_SIDED|95.0|49.15|81.0||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||81.00|49.15|<0.001
71774427|NCT05419908|143049003|SUPERIORITY||Percentage Difference|48.5|||<|0.001||95.0|30.37|66.59||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||66.59|30.37|<0.001
71774428|NCT05419908|143049003|SUPERIORITY||Percentage Difference|52.5|||<|0.001|TWO_SIDED|95.0|35.76|69.24||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||69.24|35.76|<0.001
71774429|NCT05419908|143049004|SUPERIORITY||Percentage Difference|69.0|||<|0.001|TWO_SIDED|95.0|53.7|84.21||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||84.21|53.70|<0.001
71833076|NCT01381406|143170788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.622||||0.146|TWO_SIDED|95.0|0.328|1.18||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Severe COPD Exacerbations|Regression, Logistic|||||1.180|0.328|0.146
71833077|NCT01381406|143170788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.013|TWO_SIDED|95.0|0.646|0.949||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Moderate COPD Exacerbations|Regression, Logistic|||||0.949|0.646|0.013
71833078|NCT03447249|143170791|SUPERIORITY||Least Squares (LS) Mean Difference|14.0|||<|0.0001|TWO_SIDED|95.0|12.4|15.7|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.7|12.4|<0.0001
71774430|NCT05419908|143049004|SUPERIORITY||Percentage Difference|50.7|||<|0.001||95.0|31.93|69.42||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 8||69.42|31.93|<0.001
71774431|NCT05419908|143049004|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|39.99|75.01||Likelihood-ratio test based 95% confidence interval of the percentage difference|Likelihood-Ratio Chi-Square Test|||Week 12||75.01|39.99|<0.001
71774432|NCT05419908|143049005|SUPERIORITY||Percentage Difference|54.2|||<|0.001|TWO_SIDED|95.0|37.47|70.84||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||70.84|37.47|<0.001
71774433|NCT05419908|143049005|SUPERIORITY||Percentage Difference|47.8|||<|0.001||95.0|29.62|65.99||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||65.99|29.62|<0.001
71774434|NCT05419908|143049005|SUPERIORITY||Percentage Difference|47.5|||<|0.001||95.0|28.86|66.14||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||66.14|28.86|<0.001
71774435|NCT05419908|143049006|SUPERIORITY||Percentage Difference|49.7|||<|0.001||95.0|33.54|65.79||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||65.79|33.54|<0.001
71774436|NCT05419908|143049006|SUPERIORITY||Percentage Difference|43.8|||<|0.001|TWO_SIDED|95.0|27.83|59.85||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||59.85|27.83|<0.001
71774437|NCT05419908|143049006|SUPERIORITY||Percentage Difference|42.5|||<|0.001||95.0|26.34|58.66||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||58.66|26.34|<0.001
71774438|NCT05419908|143049007|SUPERIORITY||Percentage Difference|62.8|||<|0.001|TWO_SIDED|95.0|46.56|79.05||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||79.05|46.56|<0.001
71774439|NCT05419908|143049007|SUPERIORITY||Percentage Difference|46.2|||<|0.001|TWO_SIDED|95.0|28.85|63.47||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||63.47|28.85|<0.001
71774440|NCT05419908|143049007|SUPERIORITY||Percentage Difference|57.5|||<|0.001|TWO_SIDED|95.0|41.57|73.43||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||73.43|41.57|<0.001
71774441|NCT05419908|143049008|SUPERIORITY||Percentage Difference|61.5|||<|0.001||95.0|45.4|77.55||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 4||77.55|45.40|<0.001
71774442|NCT05419908|143049008|SUPERIORITY||Percentage Difference|43.1|||<|0.001|TWO_SIDED|95.0|23.53|62.69||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 8||62.69|23.53|<0.001
71833079|NCT03447249|143170792|SUPERIORITY||LS Mean Difference|14.2|||<|0.0001|TWO_SIDED|95.0|12.6|15.7|||Mixed-effects model for repeated measure|||||15.7|12.6|<0.0001
71833080|NCT03447249|143170793|SUPERIORITY||Rate ratio|0.14|||<|0.0001|TWO_SIDED|95.0|0.09|0.24|||Negative binomial regression model|||||0.24|0.09|<0.0001
71833081|NCT03447249|143170794|SUPERIORITY||LS Mean Difference|-44.6|||<|0.0001|TWO_SIDED|95.0|-47.2|-41.9|||Mixed-effects model for repeated measure|||||-41.9|-47.2|<0.0001
71833082|NCT03447249|143170795|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|17.2|23.0|||Mixed-effects model for repeated measure|||||23.0|17.2|<0.0001
71833083|NCT03447249|143170796|SUPERIORITY||LS Mean Difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.91|1.31|||Mixed-effects model for repeated measure|||||1.31|0.91|<0.0001
71737215|NCT03916081|142988642|SUPERIORITY||LS Mean Difference|-13.53||||0.164|TWO_SIDED|95.0|-30.157|3.097|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||3.097|-30.157|0.164
71737216|NCT03916081|142988642|SUPERIORITY||LS Mean Difference|-16.48||||0.049|TWO_SIDED|95.0|-32.921|-0.048|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Percent Change from Baseline in Week 4 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||-0.048|-32.921|0.049
71737217|NCT03916081|142988643|SUPERIORITY||LS Mean Difference|-0.92||||0.44|TWO_SIDED|95.0|-2.412|0.568|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.05% vs. Vehicle Cream||0.568|-2.412|0.440
71737218|NCT03916081|142988643|SUPERIORITY||LS Mean Difference|-0.57||||0.875|TWO_SIDED|95.0|-2.061|0.914|||MMRM|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline EASI as a covariate.|Change from Baseline in Week 1 EASI Total Score: Roflumilast Cream 0.15% vs. Vehicle Cream||0.914|-2.061|0.875
71737219|NCT03916081|142988644|SUPERIORITY|||||||0.352|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.352
71737220|NCT03916081|142988644|SUPERIORITY|||||||0.803|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.803
71737221|NCT03916081|142988644|SUPERIORITY|||||||0.25|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.250
71737222|NCT03916081|142988644|SUPERIORITY|||||||0.756|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.756
71737223|NCT03916081|142988644|SUPERIORITY|||||||0.097|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.097
71660392|NCT03056157|142835055|SUPERIORITY||Slope|2.3||||0.05|TWO_SIDED|95.0|-0.03|4.63|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 1.94, d = 0.10.||4.63|-0.03|0.05
71737224|NCT03916081|142988644|SUPERIORITY|||||||0.054|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-50 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.054
71737225|NCT03916081|142988645|SUPERIORITY|||||||0.178|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.178
71737226|NCT03916081|142988645|SUPERIORITY|||||||0.046|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.046
71737227|NCT03916081|142988645|SUPERIORITY|||||||0.469|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.469
71737228|NCT03916081|142988645|SUPERIORITY|||||||0.446|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.446
71737229|NCT03916081|142988645|SUPERIORITY|||||||0.009|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.009
71737230|NCT03916081|142988645|SUPERIORITY|||||||0.045|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-75 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.045
71737231|NCT03916081|142988646|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.317
71737232|NCT03916081|142988646|SUPERIORITY|||||||0.182|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.182
71774443|NCT05419908|143049008|SUPERIORITY||Percentage Difference|52.5|||<|0.001||95.0|33.92|71.08||Likelihood-ratio test based 95% confidence interval of the percentage difference.|Likelihood-Ratio Chi-Square Test|||Week 12||71.08|33.92|<0.001
71774444|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.45|-1.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Work||-1.60|-3.45|<0.001
71774445|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.29|||<|0.001|TWO_SIDED|95.0|-3.15|-1.42||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Work||-1.42|-3.15|<0.001
71774446|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.03|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Work||-1.20|-3.03|<0.001
71774447|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.19|-1.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Social Activities||-1.46|-3.19|<0.001
71833084|NCT03447249|143170797|SUPERIORITY||LS Mean Difference|-43.4|||<|0.0001|TWO_SIDED|95.0|-46.3|-40.5|||Mixed-effects model for repeated measure|||||-40.5|-46.3|<0.0001
71833085|NCT03447249|143170798|SUPERIORITY||LS Mean Difference|17.9|||<|0.0001|TWO_SIDED|95.0|14.5|21.3|||Mixed-effects model for repeated measure|||||21.3|14.5|<0.0001
71737233|NCT03916081|142988646|SUPERIORITY|||||||0.485|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.485
71737234|NCT03916081|142988646|SUPERIORITY|||||||0.913|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.913
71737235|NCT03916081|142988646|SUPERIORITY|||||||0.288|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-90 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.288
71737236|NCT03916081|142988647|SUPERIORITY|||||||0.34|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.340
71737237|NCT03916081|142988647|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.146
71833086|NCT03447249|143170800|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|95.0|0.24|0.54||||||||0.54|0.24|
71833087|NCT03447249|143170801|SUPERIORITY||LS Mean Difference|3.2|||||TWO_SIDED|95.0|2.7|3.8||||||||3.8|2.7|
71833088|NCT03631550|143170817|SUPERIORITY|||||||0.018|||||||Chi-squared|||||||0.018
71833089|NCT03631550|143170818|SUPERIORITY|||||||0.0466|||||||Chi-squared|||||||0.0466
71833090|NCT03631550|143170819|SUPERIORITY|||||||0.0677|||||||Chi-squared|||||||0.0677
71833091|NCT03631550|143170820|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<.0001
71833092|NCT03631550|143170821|OTHER|||||||0.0968|||||||Fisher Exact|||||||0.0968
71833093|NCT03631550|143170822|SUPERIORITY|||||||0.0121|||||||ANCOVA|||||||0.0121
71833094|NCT00879060|143170847|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||1.0
71833095|NCT00879060|143170847|OTHER||Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable PIIINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.8
71833096|NCT00879060|143170847|OTHER||Mean Difference (Final Values)|0.3||||0.3|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.aseline.|t-test, 2 sided|||A two-sample T-test was used to compare continuous variable ICTP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups at baseline.||||0.3
71833097|NCT00879060|143170847|OTHER||Absolute difference|0.0||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable PINP (serum marker of collagen formation/degradation) between spironolactone treated and placebo groups.||||1.0
71833098|NCT00879060|143170848|OTHER||Absolute difference|1.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable peak oxygen consumption with exercise (peak VO2) between spironolactone treated and placebo groups.||||0.7
71833099|NCT00879060|143170849|OTHER||Absolute difference|0.0||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable New York Heart Association (NYHA) Functional Class between spironolactone treated and placebo groups.||||0.8
71833100|NCT00879060|143170850|OTHER||Absolute difference|1.4||||1|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable Septal E/e' between spironolactone treated and placebo groups.||||1.0
71833101|NCT00879060|143170851|OTHER||Absolute difference|0.2||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable percentage of left ventricular mass (%LV) between spironolactone treated and placebo groups.||||0.7
71833102|NCT00879060|143170852|OTHER||Absolute difference|0.9||||0.4|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable maximum left ventricular wall thickness (Max LV) between spironolactone treated and placebo groups.||||0.4
71833103|NCT00879060|143170853|OTHER||Absolute difference|5.7||||0.7|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left ventricular end-diastolic (LVED) cavity size between spironolactone treated and placebo groups.||||0.7
71833104|NCT00879060|143170854|OTHER||Absolute difference|0.1||||0.8|TWO_SIDED|||||An a priori threshold for statistical significance was determined at an alpha level of 0.05.|t-test, 2 sided|||A two-sample T-test was used to compare the absolute differences in change from baseline to 12 months in continuous variable left atrial dimension between spironolactone treated and placebo groups.||||0.8
71833105|NCT02539225|143170855|SUPERIORITY|||||||0.698|||||||Stratified Log Rank|||||||0.698
71833106|NCT02539225|143170856|SUPERIORITY|||||||0.549|||||||Log Rank Stratified|||||||0.549
71833107|NCT02539225|143170857|SUPERIORITY|||||||0.548|||||||Log Rank Stratified|||||||0.548
71833108|NCT02539225|143170858|SUPERIORITY||Odds Ratio (OR)|1.374||||0.402|TWO_SIDED|80.0|0.844|2.236|||Cochran-Mantel-Haenszel|||||2.236|0.844|0.402
71833109|NCT02539225|143170859|SUPERIORITY||Odds Ratio (OR)|1.527||||0.501|TWO_SIDED|80.0|0.68|3.433|||Cochran-Mantel-Haenszel|||||3.433|0.680|0.501
71833110|NCT01976312|143170880|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71833111|NCT04928001|143170921|SUPERIORITY||Mean Difference (Final Values)|31.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||t-test, 1 sided|||||60|0|.01
71737238|NCT03916081|142988647|SUPERIORITY|||||||0.967|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.967
71774448|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.21|-1.47||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Social Activties||-1.47|-3.21|<0.001
71774449|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.19|||<|0.001|TWO_SIDED|95.0|-3.09|-1.29||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Social Activties||-1.29|-3.09|<0.001
71774450|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.99|-1.31||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Leisure Activities||-1.31|-2.99|<0.001
71737239|NCT03916081|142988647|SUPERIORITY|||||||0.088|||||||Cochran-Mantel-Haenszel|Baseline vIGA-AD was included as stratification factor.||Number Achieving EASI-100 at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.088
71737240|NCT03916081|142988648|SUPERIORITY||LS Mean Difference|0.38||||0.989|TWO_SIDED|95.0|-1.098|1.852|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||1.852|-1.098|0.989
71737241|NCT03916081|142988648|SUPERIORITY||LS Mean Difference|-0.1|||>|0.999|TWO_SIDED|95.0|-1.566|1.367|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||1.367|-1.566|>0.999
71737242|NCT03916081|142988648|SUPERIORITY||LS Mean Difference|0.6||||0.966|TWO_SIDED|95.0|-1.51|2.702|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||2.702|-1.510|0.966
71774451|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.37|||<|0.001|TWO_SIDED|95.0|-3.19|-1.55||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Leisure Activties||-1.55|-3.19|<0.001
71737243|NCT03916081|142988648|SUPERIORITY||LS Mean Difference|-0.34||||0.999|TWO_SIDED|95.0|-2.415|1.744|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||1.744|-2.415|0.999
71737244|NCT03916081|142988648|SUPERIORITY||LS Mean Difference|-0.25|||>|0.999|TWO_SIDED|95.0|-2.624|2.119|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||2.119|-2.624|>0.999
71737245|NCT03916081|142988648|SUPERIORITY||LS Mean Difference|-0.94||||0.798|TWO_SIDED|95.0|-3.285|1.398|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline BSA as a covariate.|Change from Baseline in BSA Affected at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.398|-3.285|0.798
71737246|NCT03916081|142988649|SUPERIORITY||LS Mean Difference|-0.78||||0.466|TWO_SIDED|95.0|-2.075|0.506|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||0.506|-2.075|0.466
71774452|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.64||||0.002|TWO_SIDED|95.0|-2.66|-0.62||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Leisure Activties||-0.62|-2.66|0.002
71833112|NCT03990649|143170942|SUPERIORITY|||||||0.54||||||The p-values were estimated using a two-sample t-test.|t-test, 2 sided|||||||0.540
71833113|NCT01443845|143170947|SUPERIORITY_OR_OTHER||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.063||0.1634|TWO_SIDED|95.0|0.81|1.04|||negative binomial regression||p-values are based on a negative binomial regression with factors Treatment and LAMA use.|Rate ratio (Roflumilast/Placebo). A rate ratio \< 1 represents a favorable outcome for the test treatment.||1.04|0.81|0.1634
71833114|NCT01443845|143170947|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.08||0.0195|TWO_SIDED|95.0|0.71|0.97|||negative binomial regression|||Subgroup Analysis - By Sex - Male||0.97|0.71|0.0195
71833115|NCT01443845|143170947|SUPERIORITY_OR_OTHER||Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.101||0.3164|TWO_SIDED|95.0|0.91|1.35|||negative binomial regression|||Subgroup Analysis - By Sex - Female||1.35|0.91|0.3164
71889982|NCT03417440|143301866|SUPERIORITY||Estimated mean change|1468.5||||0.31|TWO_SIDED|95.0|-1368.93|4306.02|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4306.02|-1368.93|0.31
71889983|NCT03417440|143301866|SUPERIORITY||Estimated mean change|388.1||||0.78|TWO_SIDED|95.0|-2397.51|3173.62|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3173.62|-2397.51|0.78
71889984|NCT03417440|143301866|SUPERIORITY||Estimated mean change|1991.2||||0.17|TWO_SIDED|95.0|-865.52|4847.86|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||4847.86|-865.52|0.17
71774453|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.93|||<|0.001|TWO_SIDED|95.0|-4.08|-1.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sleep||-1.78|-4.08|<0.001
71833116|NCT01443845|143170947|SUPERIORITY_OR_OTHER||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.076||0.0385|TWO_SIDED|95.0|0.74|0.99|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||0.99|0.74|0.0385
71833117|NCT01443845|143170947|SUPERIORITY_OR_OTHER||Rate Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.114||0.6475|TWO_SIDED|95.0|0.84|1.32|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.||1.32|0.84|0.6475
71833118|NCT01443845|143170948|SUPERIORITY_OR_OTHER||Rate Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.118||0.6354|TWO_SIDED|95.0|0.75|1.19|||negative binomial regression|||||1.19|0.75|0.6354
71833119|NCT01443845|143170949|SUPERIORITY_OR_OTHER||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.0884|TWO_SIDED|95.0|0.8|1.02|||negative binomial regression|||||1.02|0.8|0.0884
71889985|NCT03417440|143301866|SUPERIORITY||Estimated mean change|-590.7||||0.77|TWO_SIDED|95.0|-4591.17|3409.75|||Mixed Models Analysis|||The original mixed effects regression model effects consisted of three treatment main effects, three two-way treatment interactions, and one three-way treatment interaction. Values are unadjusted.||3409.75|-4591.17|0.77
71889986|NCT03417440|143301867|SUPERIORITY||Mean Difference (Net)|-23.0|STANDARD_DEVIATION|118.7||0.17|ONE_SIDED|90.0||8.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||8.3||0.17
71774454|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.86|-1.57||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sleep||-1.57|-3.86|<0.001
71833120|NCT01443845|143170950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0532|STANDARD_ERROR_OF_MEAN|0.0067|<|0.0001|TWO_SIDED|95.0|0.04|0.0664||The MMRM analysis is based on all postbaseline observed data using a mixed model with terms for treatment, baseline, visit, LAMA use, treatment-by-visit and baseline-by-visit interactions.|Mixed Model for Repeated Measures (MMRM)|||||0.0664|0.04|< 0.0001
71833121|NCT00174382|143170954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.33||0.182||95.0|-0.21|1.09||Baseline value, center, and week as fixed effects; subject was included as a random effect.|Mixed Models Analysis|||Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.09|-0.21|0.182
71889987|NCT03417440|143301867|SUPERIORITY||Mean Difference (Net)|37.7|STANDARD_DEVIATION|117.8||0.94|ONE_SIDED|90.0||68.8||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||68.8||0.94
71889988|NCT03417440|143301867|SUPERIORITY||Mean Difference (Net)|52.0|STANDARD_DEVIATION|116.4||0.99|ONE_SIDED|90.0||82.7||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||82.7||0.99
71889989|NCT03417440|143301868|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_DEVIATION|51.0||0.47|ONE_SIDED|90.0|-12.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-12.5|0.47
71889990|NCT03417440|143301868|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|51.0||0.315|ONE_SIDED|90.0|-8.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-8.3|0.315
71889991|NCT03417440|143301868|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_DEVIATION|51.0||0.355|ONE_SIDED|90.0|-9.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-9.4|0.355
71889992|NCT03417440|143301869|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|1.0||0.86|ONE_SIDED|90.0|-1.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.3|0.86
71889993|NCT03417440|143301869|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.0||0.38|ONE_SIDED|90.0|-0.6|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.6|0.38
71737247|NCT03916081|142988649|SUPERIORITY||LS Mean Difference|-1.03||||0.18|TWO_SIDED|95.0|-2.322|0.255|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 1: Roflumilast Cream 0.15% vs. Vehicle Cream||0.255|-2.322|0.180
71737248|NCT03916081|142988649|SUPERIORITY||LS Mean Difference|-0.43||||0.967|TWO_SIDED|95.0|-1.921|1.069|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||1.069|-1.921|0.967
71737249|NCT03916081|142988649|SUPERIORITY||LS Mean Difference|-0.72||||0.684|TWO_SIDED|95.0|-2.205|0.762|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 2: Roflumilast Cream 0.15% vs. Vehicle Cream||0.762|-2.205|0.684
71833122|NCT00174382|143170954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.067||95.0|-0.05|1.36|||Mixed Models Analysis|||Week 24 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||1.36|-0.05|0.067
71737250|NCT03916081|142988649|SUPERIORITY||LS Mean Difference|-0.61||||0.856|TWO_SIDED|95.0|-2.221|1.003|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||1.003|-2.221|0.856
71737251|NCT03916081|142988649|SUPERIORITY||LS Mean Difference|-0.51||||0.932|TWO_SIDED|95.0|-2.105|1.089|||MMRM|Dunnett's method was used to control for multiple comparisons|Change from BL MMRM model includes treatment, visit, vIGA-AD strata, treatment-by-visit interaction as fixed effects and baseline WI-NRS as a covariate.|Change from Baseline in WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||1.089|-2.105|0.932
71737252|NCT03916081|142988650|SUPERIORITY|||||||0.637|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.637
71833123|NCT00174382|143170954|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Mixed Models Analysis|||Week 24 LOCF Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.||||0.085
71833124|NCT00174382|143170955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.16||0.218||95.0|-1.2|5.19|||Mixed Models Analysis|||||5.19|-1.20|0.218
71833125|NCT00174382|143170955|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.12||0.385||95.0|-6.03|2.34|||Mixed Models Analysis|||||2.34|-6.03|0.385
71833126|NCT00174382|143170955|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||Mixed Models Analysis|||||||0.228
71737253|NCT03916081|142988650|SUPERIORITY|||||||0.124|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 1: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.124
71737254|NCT03916081|142988650|SUPERIORITY|||||||0.196|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.196
71737255|NCT03916081|142988650|SUPERIORITY|||||||0.985|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 2: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.985
71737256|NCT03916081|142988650|SUPERIORITY|||||||0.401|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.05% vs. Vehicle Cream||||0.401
71737257|NCT03916081|142988650|SUPERIORITY|||||||0.996|||||||Cochran-Mantel-Haenszel|v-IGA-AD included as a stratification factor.||Number of Participants Achieving a ≥4-Point Improvement from Baseline WI-NRS at Week 4: Roflumilast Cream 0.15% vs. Vehicle Cream||||0.996
71737258|NCT01124955|142988661|SUPERIORITY_OR_OTHER||||||,|0|||||||ANOVA|||||||0,05
71833127|NCT00174382|143170956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.84|STANDARD_ERROR_OF_MEAN|2.19||0.404||95.0|-2.51|6.18|||Mixed Models Analysis|||||6.18|-2.51|0.404
71833128|NCT00174382|143170956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|2.56||0.826||95.0|-4.51|5.64|||Mixed Models Analysis|||||5.64|-4.51|0.826
71833129|NCT00174382|143170956|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||Mixed Models Analysis|||||||0.494
71833130|NCT00174382|143170957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78|STANDARD_ERROR_OF_MEAN|1.61||0.272||95.0|-1.42|4.99|||Mixed Models Analysis|||||4.99|-1.42|0.272
71833131|NCT00174382|143170957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|2.0||0.894||95.0|-4.21|3.68|||Mixed Models Analysis|||||3.68|-4.21|0.894
71833132|NCT00174382|143170957|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Mixed Models Analysis|||||||0.906
71833133|NCT00174382|143170958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.35||0.719||95.0|-0.56|0.82|||Mixed Models Analysis|||||0.82|-0.56|0.719
71833134|NCT00174382|143170958|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.36||0.006||95.0|0.29|1.71|||Mixed Models Analysis|||||1.71|0.29|0.006
71833135|NCT00174382|143170958|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Mixed Models Analysis|||||||0.007
71833136|NCT00174382|143170959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.368||95.0|-0.38|1.01|||Mixed Models Analysis|||||1.01|-0.38|0.368
71660393|NCT03056157|142835055|SUPERIORITY||Slope|3.04||||0.001|TWO_SIDED|95.0|0.75|5.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PCL-5 scores, t(1542) = 2.61, d = 0.13.||5.34|0.75|0.001
71737259|NCT02828020|142988665|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0023|TWO_SIDED|95.0|1.25|2.66||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.66|1.25|0.0023
71737260|NCT02828020|142988665|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0003|TWO_SIDED|95.0|1.41|2.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.95|1.41|0.0003
71737261|NCT02828020|142988666|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0023|TWO_SIDED|95.0|1.27|2.28||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.28|1.27|0.0023
71737262|NCT02828020|142988666|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0023|TWO_SIDED|95.0|1.22|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.17|1.22|0.0023
71774455|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.61|||<|0.001|TWO_SIDED|95.0|-3.67|-1.54||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sleep||-1.54|-3.67|<0.001
71774456|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.74|||<|0.001|TWO_SIDED|95.0|-2.67|-0.81||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Mood||-0.81|-2.67|<0.001
71774457|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.12|||<|0.001|TWO_SIDED|95.0|-3.09|-1.16||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Mood||-1.16|-3.09|<0.001
71833137|NCT00174382|143170959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.33||0.03||95.0|0.07|1.37|||Mixed Models Analysis|||||1.37|0.07|0.030
71833138|NCT00174382|143170959|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Mixed Models Analysis|||||||0.060
71833139|NCT00174382|143170960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.516||95.0|-0.44|0.86|||Mixed Models Analysis|||||0.86|-0.44|0.516
71833140|NCT00174382|143170960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.32||0.297||95.0|-0.97|0.3|||Mixed Models Analysis|||||0.30|-0.97|0.297
71660394|NCT03056157|142835056|SUPERIORITY||Odds Ratio (OR)|2.39||||0.04|TWO_SIDED|95.0|1.01|5.84|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing probable recovery in PCL-5 at post-treatment in AD-MIL versus PCT.||5.84|1.01|0.04
71660395|NCT03056157|142835056|SUPERIORITY||Odds Ratio (OR)|0.7||||0.49|TWO_SIDED|95.0|0.25|1.95|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing improvement in PCL-5 at post-treatment in AD-MIL versus PCT.||1.95|0.25|0.49
71737263|NCT02828020|142988667|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.23||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.23|1.28|0.0023
71737264|NCT02828020|142988667|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0023|TWO_SIDED|95.0|1.28|2.21||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.21|1.28|0.0023
71737265|NCT02828020|142988668|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0023|TWO_SIDED|95.0|1.65|3.07||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.07|1.65|0.0023
71833141|NCT00174382|143170960|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||Mixed Models Analysis|||||||0.133
71833142|NCT00174382|143170961|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.79|STANDARD_ERROR_OF_MEAN|0.33||0.02||95.0|0.13|1.45|||Mixed Models Analysis|||||1.45|0.13|0.020
71833143|NCT00174382|143170961|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|0.36||0.018||95.0|0.16|1.59|||Mixed Models Analysis|||||1.59|0.16|0.018
71833144|NCT00174382|143170961|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||0.004
71833145|NCT00174382|143170962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.01||95.0|-1.93|-0.27|||Mixed Models Analysis|||||-0.27|-1.93|0.010
71833146|NCT00174382|143170962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.47||0.018||95.0|-2.05|-0.19|||Mixed Models Analysis|||||-0.19|-2.05|0.018
71833147|NCT00174382|143170962|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
71833148|NCT00174382|143170963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.62||0.182||95.0|-2.06|0.39|||Mixed Models Analysis|||||0.39|-2.06|0.182
71833149|NCT00174382|143170963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|0.68||0.114||95.0|-2.44|0.26|||Mixed Models Analysis|||||0.26|-2.44|0.114
71833150|NCT00174382|143170963|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Mixed Models Analysis|||||||0.038
71833151|NCT00296036|143170968|SUPERIORITY_OR_OTHER|||||||0.768|||||||Fisher Exact|||||||0.768
71737266|NCT02828020|142988668|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0023|TWO_SIDED|95.0|1.77|3.24||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||3.24|1.77|0.0023
71737267|NCT02828020|142988669|SUPERIORITY||Odds Ratio (OR)|1.57||||0.0577|TWO_SIDED|95.0|1.01|2.44||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.44|1.01|0.0577
71737268|NCT02828020|142988669|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0037|TWO_SIDED|95.0|1.28|2.97||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.97|1.28|0.0037
71737269|NCT02828020|142988670|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0577|TWO_SIDED|95.0|1.22|2.19||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.19|1.22|0.0577
71737270|NCT02828020|142988670|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0037|TWO_SIDED|95.0|1.36|2.42||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.42|1.36|0.0037
71833152|NCT04583423|143170983|OTHER||Difference in Percentages|10.4||||0.3504|TWO_SIDED|95.0|-13.4|35.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50-mg MK-3655 minus % placebo|||35.1|-13.4|0.3504
71737271|NCT02828020|142988671|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0577|TWO_SIDED|95.0|1.16|2.09||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||2.09|1.16|0.0577
71737272|NCT02828020|142988671|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0577|TWO_SIDED|95.0|1.1|1.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.95|1.10|0.0577
71737273|NCT02828020|142988672|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0962|TWO_SIDED|95.0|0.96|1.79||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.79|0.96|0.0962
71737274|NCT02828020|142988672|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0962|TWO_SIDED|95.0|1.0|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.83|1.00|0.0962
71737275|NCT00847197|142988681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.1||0.926|TWO_SIDED|95.0|-3.9|4.3||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||4.3|-3.9|0.926
71737276|NCT00847197|142988682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|1.8||0.013|TWO_SIDED|95.0|1.0|8.1||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.||8.1|1.0|0.013
71737277|NCT00847197|142988683|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|8.6||0.02|TWO_SIDED|95.0|-18.9|-1.9|||Wilcoxon's Rank Sum Test|The significance test was 2-tailed with α=0.05.||Triglycerides was analyzed by non-parametric methods with terms for treatment, gender and region. Specifically, the analysis of variance (ANOVA) model was applied to the Tukey's normal scores of the percent change from baseline. The estimate of the difference in medians between MK1903 and the placebo groups utilizing the Hodges-Lehmann estimate and a distribution-free 95% CI for the difference based on Wilcoxon's rank sum test was provided.||-1.9|-18.9|0.02
71737278|NCT00622388|142988684|SUPERIORITY_OR_OTHER||Response rate|11.0|||||TWO_SIDED|95.0|5.0|20.0|||||Response rate is calculated as the number of responses divided by the number of participants treated, expressed as a percentage.|||20|5|
71737279|NCT00348309|142988699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.049|TWO_SIDED|95.0|-2.7|0.0||APOE4 negatives|Mixed Models Analysis|||||-0.0|-2.7|0.049
71737280|NCT00348309|142988699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.808|TWO_SIDED|95.0|-1.7|1.3||APOE4 negatives|Mixed Models Analysis|||||1.3|-1.7|0.808
71833153|NCT04583423|143170983|OTHER||Difference in Percentages|9.2||||0.373|TWO_SIDED|95.0|-15.6|32.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100-mg MK-3655 minus % placebo|||32.1|-15.6|0.3730
71833154|NCT04583423|143170983|OTHER||Difference in Percentages|15.4||||0.1428|TWO_SIDED|95.0|-8.5|42.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300-mg MK-3655 minus % placebo|||42.3|-8.5|0.1428
71737281|NCT00348309|142988699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.035|TWO_SIDED|95.0|-1.9|-0.1||All except E4/E4s|Mixed Models Analysis|||||-0.1|-1.9|0.035
71737282|NCT00348309|142988699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.999|TWO_SIDED|95.0|-1.0|1.0||All except E4/E4s|Mixed Models Analysis|||||1.0|-1.0|0.999
71737283|NCT00348309|142988699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-1.9|0.020
71737284|NCT00348309|142988699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.661|TWO_SIDED|95.0|-1.2|0.7||Full population|Mixed Models Analysis|||||0.7|-1.2|0.661
71737285|NCT00348309|142988700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.056|TWO_SIDED|95.0|-1.0|0.0||APOE4 negatives|Mixed Models Analysis|||||0.0|-1.0|=0.056
71737286|NCT00348309|142988700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.587|TWO_SIDED|95.0|-0.4|0.7||APOE4 negatives|Mixed Models Analysis|||||0.7|-0.4|=0.587
71737287|NCT00348309|142988700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.004|TWO_SIDED|95.0|-0.9|-0.2||All except E4/E4s|Mixed Models Analysis|||||-0.2|-0.9|=0.004
71737288|NCT00348309|142988700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.402|TWO_SIDED|95.0|-0.2|0.6||All except E4/E4s|Mixed Models Analysis|||||0.6|-0.2|=0.402
71737289|NCT00348309|142988700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||=|0.002|TWO_SIDED|95.0|-0.9|-0.2||Full population|Mixed Models Analysis|||||-0.2|-0.9|=0.002
71737290|NCT00348309|142988700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||=|0.478|TWO_SIDED|95.0|-0.2|0.5||Full population|Mixed Models Analysis|||||0.5|-0.2|=0.478
71737291|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||=|0.34|TWO_SIDED|95.0|-2.0|0.7||Week 8|Mixed Models Analysis|||||0.7|-2.0|=0.340
71737292|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.079|TWO_SIDED|95.0|-2.5|0.1||Week 8|Mixed Models Analysis|||||0.1|-2.5|=0.079
71737293|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.91|TWO_SIDED|95.0|-1.7|1.5||Week 16|Mixed Models Analysis|||||1.5|-1.7|=0.910
71737294|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.521|TWO_SIDED|95.0|-2.1|1.0||Week 16|Mixed Models Analysis|||||1.0|-2.1|0.521
71774458|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.79|||<|0.001|TWO_SIDED|95.0|-2.69|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Mood||-0.88|-2.69|<0.001
71774459|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Concentration||-0.97|-2.86|<0.001
71774460|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.23|||<|0.001|TWO_SIDED|94.0|-3.21|-1.25||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Concentration||-1.25|-3.21|<0.001
71774461|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.91|-0.88||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Concentration||-0.88|-2.91|<0.001
71774462|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.33||||0.003|TWO_SIDED|95.0|-2.2|-0.46||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Relations With Others||-0.46|-2.20|0.003
71774463|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Relations With others||-0.90|-2.80|<0.001
71774464|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.72|||<|0.001|TWO_SIDED|95.0|-2.66|-0.77||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Relations With Others||-0.77|-2.66|<0.001
71737295|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||=|0.154|TWO_SIDED|95.0|-0.5|3.0||Week 24|Mixed Models Analysis|||||3.0|-0.5|=0.154
71737296|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.836|TWO_SIDED|95.0|-1.6|2.0||Week 24|Mixed Models Analysis|||||2.0|-1.6|=0.836
71737297|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.061|TWO_SIDED|95.0|-0.1|4.2||Week 48|Mixed Models Analysis|||||4.2|-0.1|0.061
71737298|NCT00348309|142988701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||=|0.566|TWO_SIDED|95.0|-2.9|1.6||Week 48|Mixed Models Analysis|||||1.6|-2.9|=0.566
71737299|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||=|0.414|TWO_SIDED|95.0|-1.3|0.5||Week 8|Mixed Models Analysis|||||0.5|-1.3|=0.414
71737300|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.931|TWO_SIDED|95.0|-1.0|1.1||Week 8|Mixed Models Analysis|||||1.1|-1.0|0.931
71737301|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.485|TWO_SIDED|95.0|-1.4|0.7||Week 16|Mixed Models Analysis|||||0.7|-1.4|0.485
71737302|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5||Week 16|Mixed Models Analysis|||||1.5|-0.8|0.550
71737303|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.264|TWO_SIDED|95.0|-1.8|0.5||Week 24|Mixed Models Analysis|||||0.5|-1.8|0.264
71737304|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.732|TWO_SIDED|95.0|-1.5|1.0||Week 24|Mixed Models Analysis|||||1.0|-1.5|0.732
71737305|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.043|TWO_SIDED|95.0|-2.9|0.0||Week 48|Mixed Models Analysis|||||-0.0|-2.9|0.043
71737306|NCT00348309|142988702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.814|TWO_SIDED|95.0|-1.4|1.8||Week 48|Mixed Models Analysis|||||1.8|-1.4|0.814
71737307|NCT00348309|142988703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.87|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.870
71737308|NCT00348309|142988703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.617|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.617
71737309|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.789|TWO_SIDED|95.0|-5.2|6.9|||Mixed Models Analysis|||Week 12 Q1||6.9|-5.2|0.789
71737310|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.643|TWO_SIDED|95.0|-9.0|5.6||Week 12Q1|Mixed Models Analysis|||||5.6|-9.0|0.643
71737311|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.052|TWO_SIDED|95.0|-14.7|0.1||Week 24 Q1|Mixed Models Analysis|||||0.1|-14.7|0.052
71737312|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.481|TWO_SIDED|95.0|-14.0|6.6||Week 24 Q1|Mixed Models Analysis|||||6.6|-14.0|0.481
71737313|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.195|TWO_SIDED|95.0|-15.6|3.2||Week 36 Q1|Mixed Models Analysis|||||3.2|-15.6|0.195
71774465|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.06||||0.081|TWO_SIDED|95.0|-2.25|0.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Sexuality||0.13|-2.25|0.081
71774466|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.4||||0.05|TWO_SIDED|95.0|-2.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Sexuality||0.00|-2.80|0.050
71774467|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.51||||0.026|TWO_SIDED|95.0|-2.84|-0.19||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Sexuality||-0.19|-2.84|0.026
71833155|NCT04583423|143170986|OTHER||Difference in Least Square (LS) Means|19.1|||||TWO_SIDED|95.0|1.7|36.4|||||Difference=LS Mean 50 mg minus LS Mean Placebo|||36.4|1.7|
71660396|NCT03056157|142835056|SUPERIORITY||Odds Ratio (OR)|0.58||||0.18|TWO_SIDED|95.0|0.25|1.32|||Fisher Exact|||Odds ratio comparison of the proportions of participants experiencing no change in PCL-5 at post-treatment in AD-MIL versus PCT.||1.32|0.25|0.18
71737314|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.857|TWO_SIDED|95.0|-12.9|10.7||Week 36 Q1|Mixed Models Analysis|||||10.7|-12.9|0.857
71737315|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.422|TWO_SIDED|95.0|-15.9|6.7||Week 48 Q1|Mixed Models Analysis|||||6.7|-15.9|0.422
71737316|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.562|TWO_SIDED|95.0|-15.7|8.6||Week 48 Q1|Mixed Models Analysis|||||8.6|-15.7|0.562
71737317|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.129|TWO_SIDED|95.0|-2.6|20.2||Week 12 Q2|Mixed Models Analysis|||||20.2|-2.6|0.129
71737318|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.194|TWO_SIDED|95.0|-4.0|19.9||Week 12 Q2|Mixed Models Analysis|||||19.9|-4.0|0.194
71737319|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.832|TWO_SIDED|95.0|-10.5|13.1||Week 24 Q2|Mixed Models Analysis|||||13.1|-10.5|0.832
71737320|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.351|TWO_SIDED|95.0|-6.8|19.1||Week 24 Q2|Mixed Models Analysis|||||19.1|-6.8|0.351
71737321|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.949|TWO_SIDED|95.0|-13.3|12.5||Week 36 Q2|Mixed Models Analysis|||||12.5|-13.3|0.949
71737322|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.253|TWO_SIDED|95.0|-6.0|22.6||Week 36 Q2|Mixed Models Analysis|||||22.6|-6.0|0.253
71737323|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.735|TWO_SIDED|95.0|-16.2|11.4||Week 48 Q2|Mixed Models Analysis|||||11.4|-16.2|0.735
71833156|NCT04583423|143170986|OTHER||Difference in LS Means|19.0|||||TWO_SIDED|95.0|2.2|35.8|||||Difference=LS Mean 100 mg minus LS Mean Placebo|||35.8|2.2|
71833157|NCT04583423|143170986|OTHER||Difference in LS Means|26.1|||||TWO_SIDED|95.0|9.5|42.8|||||Difference=LS Mean 300 mg minus LS Mean Placebo|||42.8|9.5|
71833158|NCT04583423|143170987|OTHER||Difference in Percentages|1.6||||0.8978|TWO_SIDED|95.0|-26.5|30.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||30.3|-26.5|0.8978
71833159|NCT04583423|143170987|OTHER||Difference in Parentages|20.0||||0.1869|TWO_SIDED|95.0|-10.6|46.4|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||46.4|-10.6|0.1869
71833160|NCT04583423|143170987|OTHER||Difference in Percentages|8.5||||0.5636|TWO_SIDED|95.0|-22.1|38.5|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 300 mg minus % Placebo|||38.5|-22.1|0.5636
71833161|NCT04583423|143170988|OTHER||Difference in Percentages|1.6||||0.9174|TWO_SIDED|95.0|-28.6|32.6|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 50 mg minus % Placebo|||32.6|-28.6|0.9174
71833162|NCT04583423|143170988|OTHER||Difference in Percentages|18.5||||0.272|TWO_SIDED|95.0|-14.5|47.1|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference=% 100 mg minus % Placebo|||47.1|-14.5|0.2720
71833163|NCT04583423|143170988|OTHER||Difference in Percentages|5.3||||0.7586|TWO_SIDED|95.0|-26.7|37.3|||Miettinen and Nurminen's method|Stratified by concurrent diagnosis of T2DM at the time of randomization and fibrosis score and using Cochran-Mantel-Haenszel weighting scheme|Difference= % 300 mg minus % Placebo|||37.3|-26.7|0.7586
71833164|NCT00603954|143171009|SUPERIORITY|||||||0.508|||||||Multivariate Cox models|||||||0.508
71833165|NCT00603954|143171009|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||At day 180||||0.02
71833166|NCT00603954|143171009|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||At Day 365||||0.002
71833167|NCT00603954|143171010|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||At day 100||||0.09
71833168|NCT00603954|143171010|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||At Day 40||||0.03
71833169|NCT00603954|143171010|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||At Day 180||||0.01
71833170|NCT00603954|143171011|SUPERIORITY|||||||0.0165|||||||Multivariate Cox models|||||||0.0165
71660397|NCT03056157|142835057|SUPERIORITY||Slope|-0.99||||0.14|TWO_SIDED|95.0|-2.29|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = -1.46, d = 0.07||0.34|-2.29|0.14
71660398|NCT03056157|142835057|SUPERIORITY||Slope|-5.87|||<|0.001|TWO_SIDED|95.0|-6.8|-4.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -12.41, d = 1.96.||-4.90|-6.80|<0.001
71737324|NCT00348309|142988704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2||||0.046|TWO_SIDED|95.0|0.3|32.0||Week 48 Q2|Mixed Models Analysis|||||32.0|0.3|0.046
71737325|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.914|TWO_SIDED|95.0|-2.3|2.0||Week 12 Thermometer|Mixed Models Analysis|||||2.0|-2.3|0.914
71737326|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.415|TWO_SIDED|95.0|-3.3|1.4||Week 12 Thermometer|Mixed Models Analysis|||||1.4|-3.3|0.415
71737327|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.063|TWO_SIDED|95.0|-4.9|0.1||Week 36 Thermometer|Mixed Models Analysis|||||0.1|-4.9|0.063
71737328|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.03|TWO_SIDED|95.0|-5.6|-0.3||Week 36 Thermometer|Mixed Models Analysis|||||-0.3|-5.6|0.030
71774468|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.51|-0.79||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Enjoyment of Life||-0.79|-2.51|<0.001
71774469|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.97|-1.18||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Enjoyment of Life||-1.18|-2.97|<0.001
71774470|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.88|-0.78||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Enjoyment of Life||-0.78|-2.88|<0.001
71774471|NCT05419908|143049009|SUPERIORITY||LSMean difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.86|-0.97||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week4: Overall Quality of Life||-0.97|-2.86|<0.001
71774472|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.51|||<|0.001|TWO_SIDED|95.0|-3.41|-1.61||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Quality of Life||-1.61|-3.41|<0.001
71833171|NCT00603954|143171011|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|||||Mutivariate|||||||0.010
71833172|NCT00603954|143171011|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0495|TWO_SIDED|95.0|||||Multivariate|||||||0.0495
71660399|NCT03056157|142835057|SUPERIORITY||Slope|-4.89|||<|0.001|TWO_SIDED|95.0|-5.82|-3.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(161) = -10.29, d = 1.62.||-3.94|-5.82|<0.001
71660400|NCT03056157|142835057|SUPERIORITY||Slope|0.02||||0.68|TWO_SIDED|95.0|-0.99|1.53|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 0.42, d = 0.02.||1.53|-0.99|0.68
71660401|NCT03056157|142835057|SUPERIORITY||Slope|1.36||||0.003|TWO_SIDED|95.0|0.48|2.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 3.02, d = 0.15.||2.24|0.48|0.003
71660402|NCT03056157|142835057|SUPERIORITY||Slope|1.09||||0.02|TWO_SIDED|95.0|0.19|1.99|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for PHQ-9 scores, t(1550) = 2.37, d = 0.12.||1.99|0.19|0.02
71660403|NCT03056157|142835058|SUPERIORITY||Slope|-0.2||||0.18|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = -1.35, d = 0.15.||0.09|-0.49|0.18
71660404|NCT03056157|142835058|SUPERIORITY||Slope|-0.26||||0.02|TWO_SIDED|95.0|-0.47|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -2.44, d = 0.46.||-0.05|-0.47|0.02
71737329|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.392|TWO_SIDED|95.0|-1.5|3.8||Week 48 Thermometer|Mixed Models Analysis|||||3.8|-1.5|0.392
71737330|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.557|TWO_SIDED|95.0|-3.7|2.0||Week 48 Thermometer|Mixed Models Analysis|||||2.0|-3.7|0.557
71737331|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.03||Week 12 Utility|Mixed Models Analysis|||||0.03|-0.01|0.320
71737332|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.18|TWO_SIDED|95.0|-0.04|0.01||Week 12 Utility|Mixed Models Analysis|||||0.01|-0.04|0.180
71737333|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.498|TWO_SIDED|95.0|-0.02|0.04||Week 36 Utility|Mixed Models Analysis|||||0.04|-0.02|0.498
71737334|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.081|TWO_SIDED|95.0|-0.06|0.0||Week 36 Utility|Mixed Models Analysis|||||0.00|-0.06|0.081
71737335|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.077|TWO_SIDED|95.0|0.0|0.06||Week 48 Utility|Mixed Models Analysis|||||0.06|-0.00|0.077
71737336|NCT00348309|142988705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.64|TWO_SIDED|95.0|-0.04|0.03||Week 48 Utility|Mixed Models Analysis|||||0.03|-0.04|0.640
71737337|NCT00348309|142988706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.105|TWO_SIDED|95.0|-1.6|0.2|||ANCOVA|||||0.2|-1.6|0.105
71737338|NCT00348309|142988706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.483|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.483
71737339|NCT00348309|142988707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||||-0.2|-0.9|0.004
71737340|NCT00348309|142988707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.554|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||||0.5|-0.3|0.554
71737341|NCT00348309|142988708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.292|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.292
71833173|NCT00603954|143171011|SUPERIORITY||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|||||Multivariate|||||||0.001
71833174|NCT00603954|143171012|SUPERIORITY|||||||0.15|||||||Fisher Exact|||19 of 49 Flu-TBI patients (39%) versus 25 of 45 TLI ATG patients (56%) had a least one episode of bacterial infection the first 100 days after transplantation (P = 0.15).||||0.15
71737342|NCT00348309|142988708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.297|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||||1.1|-0.3|0.297
71737343|NCT00348309|142988709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.598|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.598
71737344|NCT00348309|142988709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.073|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.073
71737345|NCT00348309|142988710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.006|TWO_SIDED|95.0|0.02|0.12|||ANCOVA|||||0.12|0.02|0.006
71737346|NCT00348309|142988710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.14|TWO_SIDED|95.0|-0.01|0.09|||ANCOVA|||||0.09|-0.01|0.140
71737347|NCT00348309|142988720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.027|TWO_SIDED|95.0|-1.2|-0.1||Week 12|Mixed Models Analysis|||||-0.1|-1.2|0.027
71737348|NCT00348309|142988720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.091|TWO_SIDED|95.0|-1.1|0.1||Week 12|Mixed Models Analysis|||||0.1|-1.1|0.091
71737349|NCT00348309|142988720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.268|TWO_SIDED|95.0|-1.1|0.3||Week 36|Mixed Models Analysis|||||0.3|-1.1|0.268
71737350|NCT00348309|142988720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.318|TWO_SIDED|95.0|-1.1|0.4||Week 36|Mixed Models Analysis|||||0.4|-1.1|0.318
71737351|NCT00348309|142988720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.03|TWO_SIDED|95.0|-1.6|-0.1||Week 48|Mixed Models Analysis|||||-0.1|-1.6|0.030
71660405|NCT03056157|142835058|SUPERIORITY||Slope|-0.06||||0.62|TWO_SIDED|95.0|-0.26|0.14|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.69, d = 0.12.||0.14|-0.26|0.62
71774473|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.36|||<|0.001|TWO_SIDED|95.0|-3.31|-1.41||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Quality of Life||-1.41|-3.31|<0.001
71737352|NCT00348309|142988720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.797|TWO_SIDED|95.0|-0.9|0.7||Week 48|Mixed Models Analysis|||||0.7|-0.9|0.797
71737353|NCT00223704|142988732|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||This P-value is for the main comparison of receiving any transfusion.|Chi-squared|||||||0.72
71737354|NCT00223704|142988733|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.88
71737355|NCT00223704|142988734|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.43
71737356|NCT00223704|142988735|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||The P-value reflects the difference in Interleukin-6 concentrations among the 3 treatment groups over the course of the study (baseline, post-bypass, postoperative day 1 and 2)|Mixed Models Analysis|||The time course for Interleukin-6 concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||0.92
71774474|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.73|-1.23||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 4: Overall Mean Score||-1.23|-2.73|<0.001
71774475|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-2.21|||<|0.001|TWO_SIDED|95.0|-3.02|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 8: Overall Mean Score||-1.40|-3.02|<0.001
71737357|NCT00223704|142988736|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The P-value reflects the difference in D-dimer concentrations among the 3 treatment groups over the course of the study (baseline, 30min, 60min, post-bypass, and postoperative day 1)|Mixed Models Analysis|||The time course for D-dimer concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model||||<0.001
71737358|NCT04978818|142988739|NON_INFERIORITY|The anti-PRP IgG GMC for children receiving dose 1 of Vaxelis® was defined a priori as non-inferior if it was within a 1.5-fold margin of the GMC for children receiving dose 1 of PedvaxHIB®, corresponding to the lower bound of the 95% confidence interval (CI) of the IgG GMC ratio (Vaxelis® to PedvaxHIB®) being greater than 0.67.|Ratio of Geometric Mean Concentration|1.03||||0.85|TWO_SIDED|95.0|0.75|1.41|||Constrained Longitudinal Analysis||The lower bound of the 95% confidence interval was greater than the pre-specified non-inferiority margin of 0.67. Thus, Vaxelis® post-dose 1 anti-PRP IgG immunogenicity met the non-inferiority criterion compared to PedvaxHIB®.|||1.41|0.75|0.85
71737359|NCT04978818|142988740|OTHER|||||||0.39|||||||Chi-squared|||||||0.39
71774476|NCT05419908|143049009|SUPERIORITY||LSMean Difference|-1.98|||<|0.001|TWO_SIDED|95.0|-2.83|-1.13||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline weekly hfrdis as covariate.|ANCOVA|||Week 12: Overall Mean Score||-1.13|-2.83|<0.001
71737360|NCT04978818|142988741|OTHER|||||||0.64|||||||Chi-squared|||||||0.64
71737361|NCT04978818|142988742|OTHER|||||||0.87|||||||Chi-squared|||||||0.87
71737362|NCT04978818|142988743|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
71737363|NCT04978818|142988744|OTHER|||||||0.15|||||||Chi-squared|||||||0.15
71737364|NCT04978818|142988745|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71737365|NCT01211340|142988746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.18
71737366|NCT01211340|142988746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Regression, Linear|No significant difference found between groups||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.18
71737367|NCT01211340|142988746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED|95.0|||||Spearmans rank|No differences found||To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficient||||.18
71737368|NCT01211340|142988747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|95.0|||||Wilcxon Rank Sum Test|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.15
71737369|NCT01211340|142988747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.15
71737370|NCT01211340|142988748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.||||.89
71737371|NCT01211340|142988748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.||||.89
71737372|NCT03755661|142988749|OTHER|pilot data to estimate effect size f-squared as the parameter as primary outcome||||||0.048||||||provide inferential statistics for data completion. Study is not designed to detect significant differences between groups|Regression, Linear|R-square change = .12; F-change (1, 20) = 4.44||pilot study to calculate effect size, study is not powered to detect significant group differences|"Computed f-squared as effect size estimate where baseline value of heavy drinking episodes entered in step 1 and condition in step 2~f- squared = .22"|||.048
71737373|NCT03755661|142988750|SUPERIORITY|"The main outcome variable is f-squared as an estimate of differences between conditions controlling for baseline value.~A statistical test is provided only for completeness as this study is not powered to detect significant effects"||||||0.34||||||F-change (1, 20) = 0.97|Regression, Linear|||pilot trial to compute effect size estimate|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.34
71737374|NCT03755661|142988751|SUPERIORITY|This is a pilot trial to estimate effect sizes and not powered to detect significant differences||||||0.2||||||data provided for completeness, not powered to test differences|Regression, Linear|F-change (1, 20) = 1.80|||Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .058|||.20
71737375|NCT03755661|142988752|SUPERIORITY|Pilot trial not powered to detect significant group differences. Data from analyses presented for completeness. Primary outcome is effect size estimates||||||0.19|||||||Regression, Linear|F-change (1, 20) = 1.83||Pilot trial not powered to detect significant group differences|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .09, r-squared change = .048|||.19
71737376|NCT03755661|142988753|SUPERIORITY|||||||0.26||||||F-change (1, 19) = 1.34|Regression, Linear|||Not powered to test significant differences. provide data on effect size estimate below|Computed f-squared as effect size estimate where baseline value of CAI entered in step 1 and condition in step 2 f- squared = .05, r-squared change = .04|||.26
71737377|NCT05399290|142988758|OTHER|Chi square analysis was conducted to detect any significant between group differences (100 mg vs 20 mg) in perceived acne severity.||||||0.677|||||||Chi-squared|||||||0.677
71737378|NCT05399290|142988758|OTHER|Friedman's test was conducted for the 100 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.002|||||||Friedman's test|||||||0.002
71737379|NCT05399290|142988758|OTHER|Friedman's test was conducted for the 20 mg treatment arm to detect any significant within group differences in perceived acne severity.||||||0.018|||||||Fried|||||||0.018
71737380|NCT01115673|142988836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|469.37|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
71737381|NCT01115673|142988836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.09||||0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||0.001
71833175|NCT00603954|143171012|SUPERIORITY|||||||0.19|||||||Fisher Exact|||For fungal infections, the figures were 3 of 45 (6%) and 7 of 45 (16%), respectively (P = 0.19)||||0.19
71833176|NCT00603954|143171012|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Among CMV-seropositive patients and/or donors, the 100-day cumulative incidence of CMV reactivation was 31% in Flu-TBI patients versus 47% in TLI-ATG patient||||0.12
71833177|NCT00603954|143171013|SUPERIORITY||Multivariate Cox models|2.3|STANDARD_DEVIATION|0.02||0.017|TWO_SIDED|95.0|1.1|4.7|||Cumulative incidence curves|||Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively||4.7|1.1|0.017
71737382|NCT01115673|142988836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|367.28|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.||||<0.001
71737383|NCT01115673|142988837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|226.7|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737384|NCT01115673|142988837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.14||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71737385|NCT01115673|142988837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|178.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737386|NCT01115673|142988838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|242.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737387|NCT01115673|142988838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.95||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737388|NCT01115673|142988838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|188.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737389|NCT01115673|142988839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.037||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.037
71737390|NCT01115673|142988839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.294||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.294
71833178|NCT00603954|143171014|SUPERIORITY||Median Difference (Final Values)|4.0|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 0||||
71737391|NCT01115673|142988839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.006||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
71737392|NCT01115673|142988840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.85|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737393|NCT01115673|142988840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.946||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.946
71833179|NCT00603954|143171014|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 3||||
71833180|NCT00603954|143171014|SUPERIORITY||Mean Difference (Final Values)|0.95|||||TWO_SIDED|||||||||This statistical analysis applies to median ATG serum levels at day 10||||
71833181|NCT00603954|143171015|SUPERIORITY|||||||0.5|||||||Cumulative incidence curve|||||||0.5
71833182|NCT00603954|143171016|SUPERIORITY||multivariate analyses|2.0|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|1.0|4.1|||Kaplan-Meier method|||||4.1|1|0.14
71737394|NCT01115673|142988840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737395|NCT01115673|142988841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737396|NCT01115673|142988841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.661||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.661
71833183|NCT00603954|143171018|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.9|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.9
71833184|NCT00603954|143171019|SUPERIORITY||multivariate analyses|1.2|STANDARD_DEVIATION|0.02||0.96|TWO_SIDED|95.0|1.0|1.4|||Kaplan-Meier method|||||1.4|1|0.96
71833185|NCT01066026|143171020|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|pilot study.|descritive variables|50.0|||<|0.0001|TWO_SIDED|95.0|5.0|95.0|||McNemar||50 was the percentage of hematomas expected for standard needle group.|||95|5|<0.0001
71833186|NCT02238483|143171035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.2371|TWO_SIDED|95.0|0.81|2.4|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.||2.40|0.81|0.2371
71890297|NCT03952559|143302133|SUPERIORITY||LS Mean difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|1.571||0.5098|TWO_SIDED|95.0|-4.12|2.05|||Mixed Models Analysis|||for 8 to \<18 years old||2.05|-4.12|0.5098
71737397|NCT01115673|142988841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.62|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737398|NCT01115673|142988842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737399|NCT01115673|142988842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.13||95.0||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.13
71737400|NCT01115673|142988842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737401|NCT01115673|142988843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737402|NCT01115673|142988843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.041||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.041
71737403|NCT01115673|142988843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737404|NCT01115673|142988844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737405|NCT01115673|142988844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.34||||0.02||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.02
71737406|NCT01115673|142988844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.63|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71889994|NCT03417440|143301869|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_DEVIATION|1.0||0.66|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.66
71737407|NCT01115673|142988845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.46|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737408|NCT01115673|142988845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.08||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71889995|NCT03417440|143301870|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|19.2||0.69|ONE_SIDED|90.0|-6.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.9|0.69
71737409|NCT01115673|142988845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.38|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737410|NCT01115673|142988846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737411|NCT01115673|142988846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.83||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737412|NCT01115673|142988846|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.59|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737413|NCT01115673|142988847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71660406|NCT03056157|142835058|SUPERIORITY||Slope|0.16||||0.18|TWO_SIDED|95.0|-0.07|0.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(314) = 1.34, d = 0.15.||0.39|-0.07|0.18
71737414|NCT01115673|142988847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737415|NCT01115673|142988847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737416|NCT01115673|142988848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737417|NCT01115673|142988848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737418|NCT01115673|142988848|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737419|NCT01115673|142988849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737420|NCT01115673|142988849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737421|NCT01115673|142988849|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71774477|NCT05419908|143049010|SUPERIORITY||LSMean Difference|1.375|||<|0.001|TWO_SIDED|95.0|0.651|2.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Getting to Sleep||2.100|0.651|<0.001
71774478|NCT05419908|143049010|SUPERIORITY||LSMean Difference|1.166|||<|0.001|TWO_SIDED|95.0|0.505|1.827||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Getting to Sleep||1.827|0.505|<0.001
71774479|NCT05419908|143049010|SUPERIORITY||LSMean Difference|0.895||||0.014|TWO_SIDED|95.0|0.19|1.599||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Getting to Sleep||1.599|0.190|0.014
71774480|NCT05419908|143049010|SUPERIORITY||LSMean Difference|2.423|||<|0.001|TWO_SIDED|95.0|1.308|3.539||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Quality of Sleep||3.539|1.308|<0.001
71774481|NCT05419908|143049010|SUPERIORITY||LSMean Difference|2.291|||<|0.001|TWO_SIDED|95.0|1.31|3.251||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Quality of Sleep||3.251|1.31|<0.001
71774482|NCT05419908|143049010|SUPERIORITY||LSMean Difference|2.433|||<|0.001|TWO_SIDED|95.0|1.334|3.532||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Quality of Sleep||3.532|1.334|<0.001
71774483|NCT05419908|143049010|SUPERIORITY||LSMean Difference|0.877||||0.059|TWO_SIDED|95.0|-0.034|1.789||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Awake Following Sleep||1.789|-0.034|0.059
71774484|NCT05419908|143049010|SUPERIORITY||LSMean Difference|1.457||||0.001|TWO_SIDED|95.0|0.579|2.335||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Awake Following Sleep||2.335|0.579|0.001
71774485|NCT05419908|143049010|SUPERIORITY||LSMean Difference|1.113||||0.031|TWO_SIDED|95.0|0.107|2.12||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Awake Following Sleep||2.120|0.107|0.031
71774486|NCT05419908|143049010|SUPERIORITY||LSMean Difference|1.203||||0.008|TWO_SIDED|95.0|0.317|2.088||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 4: Behaviour Following Wakening||2.088|0.317|0.008
71774487|NCT05419908|143049010|SUPERIORITY||LSMean Difference|1.597||||0.001|TWO_SIDED|95.0|0.639|2.556||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 8: Behaviour Following Wakening||2.556|0.639|0.001
71737422|NCT01115673|142988850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35||||0.028||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.028
71737423|NCT01115673|142988850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.462||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.462
71737424|NCT01115673|142988850|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.008||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.008
71774488|NCT05419908|143049010|SUPERIORITY||LSMean Difference|0.842||||0.084|TWO_SIDED|95.0|-0.116|1.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline LSEQ as covariate.|ANCOVA|||Week 12: Behaviour Following Sleep||1.800|-0.116|0.084
71737425|NCT01115673|142988851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.81|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737426|NCT01115673|142988851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.907||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.907
71737427|NCT01115673|142988851|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737428|NCT01115673|142988852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.19|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737429|NCT01115673|142988852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.655||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.655
71737430|NCT01115673|142988852|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737431|NCT01115673|142988853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.15|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737432|NCT01115673|142988853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.155||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.155
71737433|NCT01115673|142988853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737434|NCT01115673|142988854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.69|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737435|NCT01115673|142988854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.04||||0.05||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.05
71737436|NCT01115673|142988854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71774489|NCT05419908|143049011|SUPERIORITY||LSMean Difference|0.0||||0.881|TWO_SIDED|95.0|-0.3|0.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Loss of Interest in Sex||0.3|-0.3|0.881
71774490|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-0.2||||0.383|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Loss of Interest in Sex||0.2|-0.6|0.383
71774491|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-0.2||||0.301|TWO_SIDED|95.0|-0.6|0.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Loss of Interest in Sex||0.2|-0.6|0.301
71774492|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-2.5||||0.02|TWO_SIDED|95.0|-4.5|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Psychological||-0.4|-4.5|0.020
71737437|NCT01115673|142988855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.83|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737438|NCT01115673|142988855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.74||||0.032||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.032
71737439|NCT01115673|142988855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737440|NCT01115673|142988856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.36|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737441|NCT01115673|142988856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.52||||0.003||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.003
71660407|NCT03056157|142835058|SUPERIORITY||Slope|0.13||||0.14|TWO_SIDED|95.0|-0.04|0.3|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = 1.49, d = 0.28.||0.30|-0.04|0.14
71660408|NCT03056157|142835058|SUPERIORITY||Slope|-0.03||||0.71|TWO_SIDED|95.0|-0.19|0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Justification scores, t(113) = -0.38, d = 0.07.||0.13|-0.19|0.71
71660409|NCT03056157|142835059|SUPERIORITY||Slope|-0.47|||<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = -3.41, d = 0.39.||-0.20|-0.74|<0.001
71660410|NCT03056157|142835059|SUPERIORITY||Slope|-0.64|||<|0.001|TWO_SIDED|95.0|-0.83|-0.44|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -6.41, d = 1.20.||-0.44|-0.83|<0.001
71660411|NCT03056157|142835059|SUPERIORITY||Slope|-0.17||||0.07|TWO_SIDED|95.0|-0.36|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -1.83, d = 0.34.||0.02|-0.36|0.07
71660412|NCT03056157|142835059|SUPERIORITY||Slope|0.35||||0.002|TWO_SIDED|95.0|0.13|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(314) = 3.13, d = 0.06.||0.57|0.13|0.002
71660413|NCT03056157|142835059|SUPERIORITY||Slope|0.18||||0.03|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = 2.21, d = 0.42.||0.34|0.02|0.03
71660414|NCT03056157|142835059|SUPERIORITY||Slope|-0.17||||0.03|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Hindsight-Bias scores, t(113) = -2.22, d = 0.42.||-0.02|-0.32|0.03
71660415|NCT03056157|142835060|SUPERIORITY||Slope|0.32||||0.01|TWO_SIDED|95.0|0.06|0.57|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = 2.46, d = 0.28.||0.57|0.06|0.01
71833187|NCT02238483|143171036|SUPERIORITY_OR_OTHER||Rate Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.33||0.249|TWO_SIDED|95.0|0.82|2.16|||regression, negative binomial||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.16|0.82|0.249
71660416|NCT03056157|142835060|SUPERIORITY||Slope|0.001||||0.95|TWO_SIDED|95.0|-0.17|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.06, d = 0.01.||0.18|-0.17|0.95
71660417|NCT03056157|142835060|SUPERIORITY||Slope|-0.31||||0.01|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = -3.32, d = 0.62.||-0.13|-0.50|0.01
71660418|NCT03056157|142835060|SUPERIORITY||Slope|-0.21||||0.04|TWO_SIDED|95.0|-0.41|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(314) = -2.02, d = 0.23.||-0.01|-0.41|0.04
71660419|NCT03056157|142835060|SUPERIORITY||Slope|-0.16||||0.03|TWO_SIDED|95.0|-0.3|-0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRGI Wrongdoing scores, t(113) = -2.18, d = 0.03.||-0.02|-0.30|0.03
71660420|NCT03056157|142835060|SUPERIORITY||Slope|0.05||||0.48|TWO_SIDED|95.0|-0.09|0.2|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for RGI Wrongdoing scores, t(113) = 0.70, d = 0.13.||0.20|-0.09|0.48
71660421|NCT03056157|142835061|SUPERIORITY||Slope|0.7||||0.45|TWO_SIDED|95.0|-1.12|2.52|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = 0.76, d = 0.09.||2.52|-1.12|0.45
71660422|NCT03056157|142835061|SUPERIORITY||Slope|-1.2||||0.08|TWO_SIDED|95.0|-2.52|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -1.79, d = 0.34.||0.12|-2.52|0.08
71660423|NCT03056157|142835061|SUPERIORITY||Slope|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.66|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(113) = -3.00, d = 0.56.||-0.66|-3.15|0.003
71660424|NCT03056157|142835061|SUPERIORITY||standardized effect size of the slope|-0.29||||0.7|TWO_SIDED|95.0|-1.75|1.17|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.39, d = 0.04.||1.17|-1.75|0.70
71660425|NCT03056157|142835061|SUPERIORITY||Slope|-0.59||||0.27|TWO_SIDED|95.0|-1.64|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -1.11, d = 0.12.||0.46|-1.64|0.27
71660426|NCT03056157|142835061|SUPERIORITY||Slope|-0.29||||0.57|TWO_SIDED|95.0|-1.32|0.72|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for TRSI scores, t(317) = -0.57, d = 0.06.||0.72|-1.32|0.57
71660427|NCT03056157|142835062|SUPERIORITY||Slope|3.41||||0.02|TWO_SIDED|95.0|0.56|6.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 2.35, d = 0.26.||6.25|0.56|0.02
71833188|NCT02238483|143171037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.1261|TWO_SIDED|95.0|0.89|2.5|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.50|0.89|0.1261
71833189|NCT02238483|143171038|SUPERIORITY_OR_OTHER||Rate ratio|1.4|STANDARD_ERROR_OF_MEAN|0.33||0.157|TWO_SIDED|95.0|0.88|2.21|||regression, negative binomial|||||2.21|0.88|0.157
71660428|NCT03056157|142835062|SUPERIORITY||Slope|6.84|||<|0.001|TWO_SIDED|95.0|4.78|8.9|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = -6.53, d = 1.21.||8.90|4.78|<0.001
71660429|NCT03056157|142835062|SUPERIORITY||Slope|3.43||||0.001|TWO_SIDED|95.0|1.47|5.4|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(116) = 3.44, d = 0.64.||5.40|1.47|0.001
71660430|NCT03056157|142835062|SUPERIORITY||Slope|0.76||||0.51|TWO_SIDED|95.0|-1.5|3.03|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = 0.66, d = 0.07.||3.03|-1.50|0.51
71660431|NCT03056157|142835062|SUPERIORITY||Slope|-0.27||||0.75|TWO_SIDED|95.0|-1.89|1.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -0.32, d = 0.04.||1.35|-1.89|0.75
71660432|NCT03056157|142835062|SUPERIORITY||Slope|-1.03||||0.2|TWO_SIDED|95.0|-2.61|0.55|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SOS-10 scores, t(326) = -1.28, d = 0.14.||0.55|-2.61|0.20
71660433|NCT03056157|142835063|SUPERIORITY||Slope|0.26||||0.004|TWO_SIDED|95.0|0.08|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 2.93, d = 0.33.||0.43|0.08|0.004
71833190|NCT02238483|143171039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.1529|TWO_SIDED|95.0|0.85|2.76|||Regression, Cox|||||2.76|0.85|0.1529
71737442|NCT01115673|142988856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737443|NCT01115673|142988857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737444|NCT01115673|142988857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.04||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737445|NCT01115673|142988857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.75|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737446|NCT01115673|142988858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737447|NCT01115673|142988858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737448|NCT01115673|142988858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.02|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737449|NCT01115673|142988859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737450|NCT01115673|142988859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737451|NCT01115673|142988859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71774493|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-3.3||||0.003|TWO_SIDED|95.0|-5.4|-1.2||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Psychological||-1.2|-5.4|0.003
71737452|NCT01115673|142988860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71774494|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-3.1||||0.005|TWO_SIDED|95.0|-5.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Psychological||-1.0|-5.2|0.005
71774495|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-0.2||||0.732|TWO_SIDED|95.0|-1.2|0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Physical||0.9|-1.2|0.732
71737453|NCT01115673|142988860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71737454|NCT01115673|142988860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737455|NCT01115673|142988861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65||||0.027||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.027
71737456|NCT01115673|142988861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49||||0.365||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.365
71737457|NCT01115673|142988861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14||||0.005||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.005
71833191|NCT02238483|143171040|SUPERIORITY_OR_OTHER||rate ratio|1.5|STANDARD_ERROR_OF_MEAN|0.4||0.129|TWO_SIDED|95.0|0.89|2.52|||regression, negative binomial|||||2.52|0.89|0.129
71833192|NCT02238483|143171041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.8543|TWO_SIDED|95.0|0.43|2.01|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||2.01|0.43|0.8543
71833193|NCT02238483|143171042|SUPERIORITY_OR_OTHER||rate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.41||0.751|TWO_SIDED|95.0|0.55|2.29|||regression, negative binomial|||||2.29|0.55|0.751
71833194|NCT02238483|143171043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.5381|TWO_SIDED|95.0|0.54|1.38|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|||1.38|0.54|0.5381
71660434|NCT03056157|142835063|SUPERIORITY||Slope|0.35|||<|0.001|TWO_SIDED|95.0|0.23|0.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 5.56, d = 1.04.||0.48|0.23|<0.001
71660435|NCT03056157|142835063|SUPERIORITY||Slope|0.1||||0.11|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 1.61, d = 0.30.||0.22|-0.02|0.11
71737458|NCT01115673|142988862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737459|NCT01115673|142988862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.923||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.923
71737460|NCT01115673|142988862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737461|NCT01115673|142988863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737462|NCT01115673|142988863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.653||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.653
71737463|NCT01115673|142988863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737464|NCT01115673|142988864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.71|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737465|NCT01115673|142988864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.21||||0.138||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.138
71774496|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-0.7||||0.282|TWO_SIDED|95.0|-1.9|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Physical||0.6|-1.9|0.282
71774497|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-0.6||||0.254|TWO_SIDED|95.0|-1.7|0.5||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Physical||0.5|-1.7|0.254
71660436|NCT03056157|142835063|SUPERIORITY||Slope|0.007||||0.92|TWO_SIDED|95.0|-0.13|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.10, d = 0.10.||0.15|-0.13|0.92
71774498|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.7|-1.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Vasomotor||-1.4|-2.7|<0.001
71774499|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.4|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Vasomotor||-1.1|-2.4|<0.001
71833195|NCT02238483|143171044|SUPERIORITY_OR_OTHER||rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|0.55|1.3|||regression, negative binomial|||||1.30|0.55|0.440
71890298|NCT03952559|143302133|SUPERIORITY||LS Mean difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.87||0.1997|TWO_SIDED|95.0|-6.08|1.27|||Mixed Models Analysis|||for 8 to \<18 years old||1.27|-6.08|0.1997
71660437|NCT03056157|142835063|SUPERIORITY||Slope|0.02||||0.75|TWO_SIDED|95.0|-0.08|0.12|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.31, d = 0.03.||0.12|-0.08|0.75
71660438|NCT03056157|142835063|SUPERIORITY||Slope|0.01||||0.86|TWO_SIDED|95.0|-0.09|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(319) = 0.18, d = 0.02.||0.11|-0.09|0.86
71660439|NCT03056157|142835064|SUPERIORITY||Slope|-2.56||||0.15|TWO_SIDED|95.0|-6.1|0.97|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.43, d = 0.16.||0.97|-6.10|0.15
71737466|NCT01115673|142988864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737467|NCT01115673|142988865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.66|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737468|NCT01115673|142988865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.043||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.043
71737469|NCT01115673|142988865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|82.2|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71833196|NCT02238483|143171045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.5474|TWO_SIDED|95.0|-1.6|0.85|||Mixed Models Analysis||LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.85|-1.60|0.5474
71833197|NCT02238483|143171046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.6352|TWO_SIDED|95.0|-2.62|4.29|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||4.29|-2.62|0.6352
71660440|NCT03056157|142835064|SUPERIORITY||Slope|-5.28|||<|0.001|TWO_SIDED|95.0|-7.83|-2.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -4.07, d = 0.76||-2.73|-7.83|<0.001
71737470|NCT01115673|142988866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737471|NCT01115673|142988866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.08||||0.024||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.024
71737472|NCT01115673|142988866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737473|NCT01115673|142988867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737474|NCT01115673|142988867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737475|NCT01115673|142988867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.23|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71774500|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.6|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Vasomotor||-1.3|-2.6|<0.001
71774501|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-4.6||||0.013|TWO_SIDED|95.0|-8.2|-1.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 4: Total Symptom Score||-1.0|-8.2|0.013
71774502|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-6.9|||<|0.001|TWO_SIDED|95.0|-10.7|-3.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 8: Total Symptom Score||-3.1|-10.7|<0.001
71774503|NCT05419908|143049011|SUPERIORITY||LSMean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.9|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline GCS as covariate.|ANCOVA|||Week 12: Total Symptom Score||-2.8|-9.9|<0.001
71660441|NCT03056157|142835064|SUPERIORITY||Slope|-2.71||||0.03|TWO_SIDED|95.0|-5.16|-0.28|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(116) = -2.19, d = 0.41.||-0.28|-5.16|0.03
71737476|NCT01115673|142988868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737477|NCT01115673|142988868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737478|NCT01115673|142988868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737479|NCT01115673|142988869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737480|NCT01115673|142988869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737481|NCT01115673|142988869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737482|NCT01115673|142988870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737483|NCT01115673|142988870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737484|NCT01115673|142988870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71890299|NCT03952559|143302133|SUPERIORITY||LS Mean difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|3.351||0.1957|TWO_SIDED|95.0|-5.11|8.35|||Mixed Models Analysis|||for 5 to \<8 years old||8.35|-5.11|0.1957
71833198|NCT02238483|143171047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2694|TWO_SIDED|95.0|-0.34|0.1|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.10|-0.34|0.2694
71833199|NCT02238483|143171048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.5144|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.07|-0.03|0.5144
71774504|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.7|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Work/School||-0.8|-2.7|<0.001
71774505|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.8|-1.3||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Work/School||-1.3|-2.8|<0.001
71774506|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Work/School||-0.8|-2.5|<0.001
71889996|NCT03417440|143301870|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|19.2||0.6|ONE_SIDED|90.0|-6.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-6.0|0.60
71889997|NCT03417440|143301870|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_DEVIATION|19.0||0.11|ONE_SIDED|90.0|-0.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.2|0.11
71889998|NCT03417440|143301871|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.0||0.94|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.94
71889999|NCT03417440|143301871|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|1.1||0.73|ONE_SIDED|90.0|-0.4|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.4|0.73
71774507|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Social Life||-0.6|-2.2|<0.001
71774508|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Social Life||-1.1|-2.7|<0.001
71774509|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Social Life||-0.7|-2.4|<0.001
71774510|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.2|-0.4||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Family Life/Home Responsibilities||-0.4|-2.2|0.005
71774511|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.9||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Family Life/Home Responsibilities||-0.9|-2.5|<0.001
71774512|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-1.6|||<|0.001|TWO_SIDED|95.0|-2.4|-0.7||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Family Life/Home Responsibilities||-0.7|-2.4|<0.001
71774513|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-6.9|-2.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Global Functional Impairment||-2.0|-6.9|<0.001
71833200|NCT02238483|143171049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.5416|TWO_SIDED|95.0|-0.1|0.05|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.05|-0.10|0.5416
71890000|NCT03417440|143301871|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.22|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.22
71890001|NCT03417440|143301872|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.46|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.46
71890300|NCT03952559|143302133|SUPERIORITY||LS Mean difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|3.864||0.0881|TWO_SIDED|95.0|-8.19|7.32|||Mixed Models Analysis|||for 5 to \<8 years old||7.32|-8.19|0.0881
71737485|NCT01115673|142988871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737486|NCT01115673|142988871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.98||||0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71737487|NCT01115673|142988871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.41|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71660442|NCT03056157|142835064|SUPERIORITY||Slope|-1.38||||0.33|TWO_SIDED|95.0|-4.17|1.42|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.97, d = 0.11.||1.42|-4.17|0.33
71737488|NCT01115673|142988872|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737489|NCT01115673|142988872|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.26
71737490|NCT01115673|142988872|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737491|NCT01115673|142988873|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737492|NCT01115673|142988873|SUPERIORITY_OR_OTHER|||||||0.934||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.934
71737493|NCT01115673|142988873|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71833201|NCT02238483|143171050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.1965|TWO_SIDED|95.0|0.0|0.02|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo|||0.02|0.00|0.1965
71737494|NCT01115673|142988874|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
71737495|NCT01115673|142988874|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
71737496|NCT01115673|142988874|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.||||<0.001
71737497|NCT01115673|142988875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71660443|NCT03056157|142835064|SUPERIORITY||Slope|-1.54||||0.13|TWO_SIDED|95.0|-3.54|0.46|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -1.51, d = 0.17.||0.46|-3.54|0.13
71737498|NCT01115673|142988875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.002||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.002
71833202|NCT02574455|143171054|OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.305|0.492||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.492|0.305|<0.0001
71833203|NCT02574455|143171055|OTHER||Hazard Ratio (HR)|0.413|||<|0.0001|TWO_SIDED|95.0|0.33|0.517||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, presence of known brain metastases at study entry, and region.|Log Rank|||||0.517|0.330|<0.0001
71833204|NCT02574455|143171056|OTHER||Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.39|0.592||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.592|0.390|<0.0001
71833205|NCT02574455|143171057|OTHER||Hazard Ratio (HR)|0.514|||<|0.0001|TWO_SIDED|95.0|0.422|0.625||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||||0.625|0.422|<0.0001
71833206|NCT02574455|143171058|OTHER||Odds Ratio (OR)|10.859|||<|0.0001|TWO_SIDED|95.0|5.59|21.095|||Cochran-Mantel-Haenszel|||ORR by IRC Assessment||21.095|5.590|<0.0001
71833207|NCT02574455|143171058|OTHER||Odds Ratio (OR)|7.363|||<|0.0001|TWO_SIDED|95.0|4.063|13.341|||Cochran-Mantel-Haenszel|||ORR by Investigator Assessment||13.341|4.063|<0.0001
71833208|NCT02574455|143171061|OTHER||Hazard Ratio (HR)|0.407||||0.0683|TWO_SIDED|95.0|0.15|1.107||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by IRC Assessment||1.107|0.150|0.0683
71660444|NCT03056157|142835064|SUPERIORITY||Slope|-0.17||||0.87|TWO_SIDED|95.0|-2.12|1.79|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DAR scores, t(325) = -0.17, d = 0.02.||1.79|-2.12|0.87
71660445|NCT03056157|142835065|SUPERIORITY||Slope|-0.37||||0.04|TWO_SIDED|95.0|-0.72|-0.01|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -2.03, d = 0.23.||-0.01|-0.72|0.04
71833209|NCT02574455|143171061|OTHER||Hazard Ratio (HR)|0.212|||<|0.0001|TWO_SIDED|95.0|0.103|0.435||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.|Log Rank|||DOR by Investigator Assessment||0.435|0.103|<0.0001
71833210|NCT02574455|143171062|OTHER||Hazard Ratio (HR)|0.317|||<|0.0001|TWO_SIDED|95.0|0.248|0.404||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by Investigator Assessment||0.404|0.248|<0.0001
71737499|NCT01115673|142988875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.12|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737500|NCT01115673|142988876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71833211|NCT02574455|143171063|OTHER||Hazard Ratio (HR)|0.406|||<|0.0001|TWO_SIDED|95.0|0.315|0.525||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.|Log Rank|||TTP by IRC Assessment||0.525|0.315|<0.0001
71833212|NCT02574455|143171064|OTHER||Odds Ratio (OR)|8.543|||<|0.0001|TWO_SIDED|95.0|5.055|14.437|||Cochran-Mantel-Haenszel|||CBR by IRC Assessment||14.437|5.055|<0.0001
71833213|NCT02574455|143171064|OTHER||Odds Ratio (OR)|7.492|||<|0.0001|TWO_SIDED|95.0|4.54|12.364|||Cochran-Mantel-Haenszel|||CBR by Investigator Assessment||12.364|4.540|<0.0001
71833214|NCT02677896|143171070|SUPERIORITY||Cox hazard ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|rPFS Treatment Comparison||0.50|0.30|<0.0001
71833215|NCT02677896|143171071|SUPERIORITY||Cox proportional hazards model|0.39|||<|0.0001|TWO_SIDED|95.0|0.3|0.5|||Log Rank|||rPFS Treatment Comparision||0.50|0.30|<0.0001
71833216|NCT02677896|143171072|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Log Rank|P-value from stratified log-rank test.|Significance level is 0.04. Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.81|0.53|<0.0001
71890002|NCT03417440|143301872|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.2||0.96|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.96
71660446|NCT03056157|142835065|SUPERIORITY||Slope|-0.83|||<|0.001|TWO_SIDED|95.0|-1.09|-0.58|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116)= -6.40, d = 1.19.||-0.58|-1.09|<0.001
71660447|NCT03056157|142835065|SUPERIORITY||Slope|-0.47||||0.002|TWO_SIDED|95.0|-0.71|-0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(116) = -3.78, d = 0.70.||-0.22|-0.71|0.002
71660448|NCT03056157|142835065|SUPERIORITY||Slope|-0.08||||0.58|TWO_SIDED|95.0|-0.37|0.21|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.56, d = 0.06.||0.21|-0.37|0.58
71660449|NCT03056157|142835065|SUPERIORITY||Slope|-0.1||||0.34|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.96, d = 0.11.||0.11|-0.31|0.34
71737501|NCT01115673|142988876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71833217|NCT02677896|143171073|SUPERIORITY||Cox hazard ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.26||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to PSA Progression Treatment Comparison||0.26|0.13|<0.0001
71833218|NCT02677896|143171074|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.31|0.48|||||Hazard ratio and 95 % CI are estimated by cox proportional hazards model.|||0.48|0.31|
71660450|NCT03056157|142835065|SUPERIORITY||Slope|-0.02||||0.85|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Psychological Aggression scores, t(319) = -0.19, d = 0.02.||0.18|-0.22|0.85
71660451|NCT03056157|142835066|SUPERIORITY|We log-transformed CTS2 scores because they were heavily positively skewed in conjunction with zero-inflation.|Slope|-0.23||||0.07|TWO_SIDED|95.0|-0.48|0.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319)= -1.82, d = 0.20.||0.02|-0.48|0.07
71660452|NCT03056157|142835066|SUPERIORITY||Slope|-0.13||||0.17|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = -1.39, d = 0.16.||-0.05|-0.31|0.17
71660453|NCT03056157|142835066|SUPERIORITY||Slope|0.1||||0.24|TWO_SIDED|95.0|-0.07|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(116) = 1.18, d = 0.13.||0.27|-0.07|0.24
71660454|NCT03056157|142835066|SUPERIORITY||Slope|0.11||||0.71|TWO_SIDED|95.0|-0.23|0.15|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.37, d = 0.04.||0.15|-0.23|0.71
71660455|NCT03056157|142835066|SUPERIORITY||Slope|-0.07||||0.32|TWO_SIDED|95.0|-0.21|0.07|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -1.00, d = 0.11.||0.07|-0.21|0.32
71737502|NCT01115673|142988876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737503|NCT01115673|142988877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737504|NCT01115673|142988877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.006||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.006
71737505|NCT01115673|142988877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.16|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737506|NCT01115673|142988878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737507|NCT01115673|142988878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71737508|NCT01115673|142988878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71737509|NCT01593592|142988887|SUPERIORITY_OR_OTHER||percentage|0.0|||||TWO_SIDED|95.0||||||||A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).||||
71660456|NCT03056157|142835066|SUPERIORITY||Slope|-0.04||||0.61|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for CTS2 Physical Assault scores, t(319) = -0.51, d = 0.06.||0.10|-0.17|0.61
71660457|NCT03056157|142835067|SUPERIORITY||Slope|-0.07||||0.74|TWO_SIDED|95.0|-0.5|0.36|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(318) = -0.33, d = 0.04||0.36|-0.50|0.74
71660458|NCT03056157|142835067|SUPERIORITY||Slope|-0.12||||0.44|TWO_SIDED|95.0|-0.43|0.19|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.77, d = 0.14.||0.19|-0.43|0.44
71774514|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-5.8|||<|0.001|TWO_SIDED|95.0|-8.0|-3.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Global Functional Impairment||-3.6|-8.0|<0.001
71774515|NCT05419908|143049012|SUPERIORITY||LSMean Difference|-5.3|||<|0.001|TWO_SIDED|95.0|-7.8|-2.8||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Global Functional Impairment||-2.8|-7.8|<0.001
71774516|NCT05419908|143049013|SUPERIORITY||LSMean difference|0.0||||0.936|TWO_SIDED|95.0|-0.5|0.6||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Lost||0.6|-0.5|0.936
71660459|NCT03056157|142835067|SUPERIORITY||Slope|-0.06||||0.74|TWO_SIDED|95.0|-0.35|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.34, d = 0.06.||0.24|-0.35|0.74
71660460|NCT03056157|142835067|SUPERIORITY||Slope|-0.1||||0.57|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.57, d = 0.11.||0.25|-0.45|0.57
71660461|NCT03056157|142835067|SUPERIORITY||Slope|-0.03||||0.82|TWO_SIDED|95.0|-0.28|0.22|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = -0.23, d = 0.04.||0.22|-0.28|0.82
71660462|NCT03056157|142835067|SUPERIORITY||Slope|0.07||||0.57|TWO_SIDED|95.0|-0.17|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for DSI-SS scores, t(114) = 0.58, d = 0.11.||0.31|-0.17|0.57
71660463|NCT03056157|142835068|SUPERIORITY||Slope|-1.1||||0.16|TWO_SIDED|95.0|-2.63|0.43|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -1.42, d = 0.16.||0.43|-2.63|0.16
71660464|NCT03056157|142835068|SUPERIORITY||Slope|-0.76||||0.18|TWO_SIDED|95.0|-1.87|0.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114)= -1.35, d = 0.25.||0.35|-1.87|0.18
71737510|NCT01732770|142988894|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% confidence interval (CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.46% for assessing non-inferiority.|Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||2.6|1.6|<0.0001
71737511|NCT01732770|142988895|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The lower bound of the 2-sided 95% CI) of (denosumab - zoledronic acid) was compared with the non-inferiority margin of -0.51% for assessing non-inferiority.|Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.||1.7|1.0|<0.0001
71737512|NCT01732770|142988896|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.1|||<|0.0001|TWO_SIDED|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||2.6|1.6|<0.0001
71737513|NCT01732770|142988897|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab - zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.||1.7|1.0|<0.0001
71737514|NCT03335774|142988910|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8918|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8918
71737515|NCT03335774|142988911|SUPERIORITY|To determine if the 'hydrocortisone' arm was indeed superior than 'placebo' to reduce swelling and itching associated with internal hemorrhoids||||||0.8323|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analyses were conducted using SAS software Version 9.4.All statistical tests were two-sided at a significance level of α = 0.05. Continuous data were presented using descriptive statistics (i.e. number of subjects, mean, SD, median, minimum, and maximum).Baseline value of each assessment was defined as the latest available assessment obtained prior to the first administration of the study drug.||||0.8323
71833219|NCT02677896|143171075|SUPERIORITY||Difference in rate|50.5|||<|0.0001|TWO_SIDED|95.0|45.3|55.7||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||PSA Undetectable Rate Treatment Comparison||55.7|45.3|<0.0001
71833220|NCT02677896|143171076|SUPERIORITY||Difference in rate|19.3|||<|0.0001|TWO_SIDED|95.0|10.4|28.2||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||ORR Treatment Comparison||28.2|10.4|<0.0001
71833221|NCT02677896|143171077|SUPERIORITY||Cox hazard ratio|0.88||||0.2162|TWO_SIDED|95.0|0.72|1.08||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Deterioration of Urinary Symptoms Treatment Comparison||1.08|0.72|0.2162
71833222|NCT02677896|143171078|SUPERIORITY||Cox hazard ratio|0.52||||0.0026|TWO_SIDED|95.0|0.33|0.8|||Log Rank|||Time to SSE Treatment Comparison||0.80|0.33|0.0026
71833223|NCT02677896|143171079|SUPERIORITY||Cox hazard ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.22|0.36|||Log Rank|||Time to Castration Resistance Treatment Comparison||0.36|0.22|<0.0001
71833224|NCT02677896|143171080|SUPERIORITY||Cox hazard ratio|0.96||||0.6548|TWO_SIDED|95.0|0.81|1.14|||Log Rank|||Time to Deterioration of QoL in FACT-P Treatment Comparison||1.14|0.81|0.6548
71833225|NCT02677896|143171081|SUPERIORITY||Cox hazard ratio|0.92||||0.2715|TWO_SIDED|95.0|0.78|1.07|||Log Rank|||Time to Pain Progression Based on BPI-SF Treatment Comparison||1.07|0.78|0.2715
71890003|NCT03417440|143301872|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.3||0.495|ONE_SIDED|90.0|-0.3|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.3|0.495
71890004|NCT03417440|143301873|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.5||0.445|ONE_SIDED|90.0|-1.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.1|0.445
71890005|NCT03417440|143301873|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|4.4||0.92|ONE_SIDED|90.0|-2.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-2.5|0.92
71890006|NCT03417440|143301873|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_DEVIATION|4.5||0.23|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.23
71890301|NCT03952559|143302133|SUPERIORITY||LS Mean difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.379||0.1604|TWO_SIDED|95.0|-5.27|8.28|||Mixed Models Analysis|||for 5 to \<8 years old||8.28|-5.27|0.1604
71737516|NCT00244101|142988925|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.59|1.03||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX or NCPAP.||1.03|0.59|
71737517|NCT00244101|142988925|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.25|1.27||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.27|0.25|
71737518|NCT00244101|142988926|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.94||||||PS group used as standard of care. Relative risk and 95 % CI calculated for PS (reference) versus ISX.||1.94|0.49|
71737519|NCT00244101|142988926|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.64|1.09||||||PS group used as standard of care. Relative risk and 95% CI calculated for PS (reference) versus NCPAP.||1.09|0.64|
71737520|NCT01959139|142988928|SUPERIORITY||Hazard Ratio (HR)|2.07|||<|0.01|TWO_SIDED|95.0|1.28|3.34|||Regression, Cox|||||3.34|1.28|<0.01
71737521|NCT01959139|142988929|SUPERIORITY||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66|||Regression, Cox|||||2.66|1.14|0.01
71737522|NCT04756804|142988935|OTHER|This was a descriptive study, no hypothesis testing was performed.|||||||||||||||||This was a descriptive study, no hypothesis testing was performed.|||
71737523|NCT05362058|142988939|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.09|||||TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|
71737524|NCT05362058|142988940|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.26|0.13|||ANCOVA|||||0.13|-0.26|
71737525|NCT05362058|142988941|NON_INFERIORITY|0.4% noninferiority margin (NIM)|LS Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.28|0.07|||ANCOVA|||||0.07|-0.28|
71737526|NCT05362058|142988942|SUPERIORITY||LS Mean Difference|-0.09||||0.188|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||||0.04|-0.22|0.188
71737527|NCT05362058|142988943|SUPERIORITY||LS Mean Difference|3.09||||0.043|TWO_SIDED|95.0|0.09|6.08|||ANCOVA|||||6.08|0.09|0.043
71737528|NCT05362058|142988944|SUPERIORITY||LS Mean Difference|-0.06||||0.26|TWO_SIDED|95.0|-0.17|0.05|||ANCOVA|||||0.05|-0.17|0.260
71737529|NCT05362058|142988945|SUPERIORITY||LS Mean Difference|0.27||||0.848|TWO_SIDED|95.0|-2.48|3.02|||ANCOVA|||||3.02|-2.48|0.848
71737530|NCT05362058|142988946|SUPERIORITY||LS Mean Difference|5.18||||0.014|TWO_SIDED|95.0|1.06|9.3|||ANCOVA|||Week 26 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 26 were imputed by return-to-baseline multiple imputations approach.||9.30|1.06|0.014
71737531|NCT05362058|142988946|SUPERIORITY||LS Mean Difference|0.2||||0.918|TWO_SIDED|95.0|-3.65|4.06|||ANCOVA|||Week 52 (Statistical Analysis) - LS mean was determined using ANCOVA model with Baseline + Country + HbA1c Stratum at Baseline + GLP-1 RA Use at Randomization + SU Use at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at week 52 were imputed by return-to-baseline multiple imputations approach.||4.06|-3.65|0.918
71737532|NCT05362058|142988947|SUPERIORITY||LS Mean Difference|-0.36||||0.31|TWO_SIDED|95.0|-1.06|0.34|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.34|-1.06|0.310
71737533|NCT05362058|142988947|SUPERIORITY||LS Mean Difference|-0.51||||0.138|TWO_SIDED|95.0|-1.19|0.17|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.17|-1.19|0.138
71737534|NCT05362058|142988948|SUPERIORITY||LS Mean Difference|-13.2||||0.136|TWO_SIDED|95.0|-30.5|4.1|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||4.1|-30.5|0.136
71737535|NCT05362058|142988948|SUPERIORITY||LS Mean Difference|-19.7||||0.026|TWO_SIDED|95.0|-37.0|-2.4|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||-2.4|-37.0|0.026
71737536|NCT05362058|142988949|SUPERIORITY||Relative Rate|1.3||||0.111|TWO_SIDED|95.0|0.94|1.78|||Negative binomial model|||||1.78|0.94|0.111
71737537|NCT05362058|142988950|SUPERIORITY||Relative Rate|1.01||||0.983|TWO_SIDED|95.0|0.53|1.89|||Negative binomial model|||||1.89|0.53|0.983
71737538|NCT05362058|142988951|SUPERIORITY||LS Mean Difference|0.5||||0.025|TWO_SIDED|95.0|0.064|0.94|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||0.94|0.064|0.025
71737539|NCT05362058|142988951|SUPERIORITY||LS Mean Difference|0.056||||0.801|TWO_SIDED|95.0|-0.38|0.5|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||0.50|-0.38|0.801
71737540|NCT05362058|142988952|SUPERIORITY||LS Mean Difference|0.13||||0.374|TWO_SIDED|95.0|-0.15|0.41|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.41|-0.15|0.374
71737541|NCT05362058|142988952|SUPERIORITY||LS Mean Difference|0.29||||0.13|TWO_SIDED|95.0|-0.09|0.67|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.67|-0.09|0.130
71737542|NCT05362058|142988952|SUPERIORITY||LS Mean Difference|0.3||||0.162|TWO_SIDED|95.0|-0.12|0.72|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.72|-0.12|0.162
71737543|NCT05362058|142988953|SUPERIORITY||LS Mean Difference|-0.03||||0.594|TWO_SIDED|95.0|-0.15|0.08|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||0.08|-0.15|0.594
71737544|NCT05362058|142988953|SUPERIORITY||LS Mean Difference|0.06||||0.266|TWO_SIDED|95.0|-0.04|0.16|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||0.16|-0.04|0.266
71737545|NCT05362058|142988953|SUPERIORITY||LS Mean Difference|0.02||||0.791|TWO_SIDED|95.0|-0.1|0.14|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||0.14|-0.10|0.791
71737546|NCT05362058|142988954|SUPERIORITY||LS Mean Difference|-0.41||||0.757|TWO_SIDED|95.0|-3.0|2.18|||Mixed Models Analysis|||Week 8 to Week 12 (Statistical Analysis)||2.18|-3.00|0.757
71737547|NCT05362058|142988954|SUPERIORITY||LS Mean Difference|-0.93||||0.511|TWO_SIDED|95.0|-3.72|1.85|||Mixed Models Analysis|||Week 22 to Week 26 (Statistical Analysis)||1.85|-3.72|0.511
71737548|NCT05362058|142988954|SUPERIORITY||LS Mean Difference|-3.39||||0.027|TWO_SIDED|95.0|-6.39|-0.39|||Mixed Models Analysis|||Week 48 to Week 52 (Statistical Analysis)||-0.39|-6.39|0.027
71737549|NCT05362058|142988955|SUPERIORITY||LS Mean Difference|1.66||||0.021|TWO_SIDED|95.0|0.26|3.07|||Mixed Models Analysis|||Week 26 (Statistical Analysis)||3.07|0.26|0.021
71737550|NCT05362058|142988955|SUPERIORITY||LS Mean Difference|2.0||||0.006|TWO_SIDED|95.0|0.57|3.44|||Mixed Models Analysis|||Week 52 (Statistical Analysis)||3.44|0.57|0.006
71833226|NCT00567489|143171082|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
71660465|NCT03056157|142835068|SUPERIORITY||Slope|0.34||||0.53|TWO_SIDED|95.0|-0.71|1.39|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 0.63, d = 0.12.||1.39|-0.71|0.53
71660466|NCT03056157|142835068|SUPERIORITY||Slope|-0.6||||0.37|TWO_SIDED|95.0|-1.93|0.73|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(316) = -0.89, d = 0.12.||0.73|-1.93|.37
71737551|NCT05362058|142988956|SUPERIORITY||LS Mean Difference|-0.2||||0.638|TWO_SIDED|95.0|-1.03|0.63|||Mixed Models Analysis|||Physical Component Score at Week 26 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.63|-1.03|0.638
71737552|NCT05362058|142988956|SUPERIORITY||LS Mean Difference|-0.32||||0.499|TWO_SIDED|95.0|-1.24|0.6|||Mixed Models Analysis|||Mental Component Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-1.24|0.499
71737553|NCT05362058|142988956|SUPERIORITY||LS Mean Difference|0.17||||0.695|TWO_SIDED|95.0|-0.68|1.01|||Mixed Models Analysis|||Physical Component Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.01|-0.68|0.695
71737554|NCT05362058|142988956|SUPERIORITY||LS Mean Difference|-0.23||||0.626|TWO_SIDED|95.0|-1.17|0.71|||Mixed Models Analysis|||Mental Component Score at Week 52 (Statistical Analysis) -LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use at Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.71|-1.17|0.626
71737555|NCT05362058|142988957|SUPERIORITY||LS Mean Difference|-0.015||||0.128|TWO_SIDED|95.0|-0.034|0.004|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.004|-0.034|0.128
71737556|NCT05362058|142988957|SUPERIORITY||LS Mean Difference|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.58|||Mixed Models Analysis|||EQ VAS Score at Week 26 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.58|-2.80|0.196
71737557|NCT05362058|142988957|SUPERIORITY||LS Mean Difference|-0.01||||0.285|TWO_SIDED|95.0|-0.029|0.008|||Mixed Models Analysis|||EQ-5D-5L Health State Index Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.008|-0.029|0.285
71737558|NCT05362058|142988957|SUPERIORITY||LS Mean Difference|-0.35||||0.701|TWO_SIDED|95.0|-2.15|1.44|||Mixed Models Analysis|||EQ VAS Score at Week 52 (Statistical Analysis) - LS mean was determined using MMRM model with Baseline + HbA1c Stratum at Baseline + Country + GLP-1 RA Use Randomization Flag + SU Use at Randomization Flag + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||1.44|-2.15|0.701
71737559|NCT00930553|142988974|SUPERIORITY_OR_OTHER||Percentage with SAD|22.33|||||TWO_SIDED|95.0|18.33|27.06|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||27.06|18.33|
71737560|NCT00930553|142988974|SUPERIORITY_OR_OTHER||Percentage with SAD|29.69|||||TWO_SIDED|95.0|25.42|34.49|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||34.49|25.42|
71737561|NCT00930553|142988975|SUPERIORITY_OR_OTHER||Percentage with SAD|9.35|||||TWO_SIDED|95.0|5.54|15.56|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||15.56|5.54|
71737562|NCT00930553|142988975|SUPERIORITY_OR_OTHER||Percentage with SAD|7.95|||||TWO_SIDED|95.0|4.48|13.9|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||13.90|4.48|
71737563|NCT00930553|142988975|SUPERIORITY_OR_OTHER||Percentage with SAD|20.42|||||TWO_SIDED|95.0|14.67|28.03|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||28.03|14.67|
71737564|NCT00930553|142988975|SUPERIORITY_OR_OTHER||Percentage with SAD|11.99|||||TWO_SIDED|95.0|7.63|18.58|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.|||18.58|7.63|
71737565|NCT00930553|142988976|SUPERIORITY_OR_OTHER||Percentage with SRD|32.69|||||TWO_SIDED|95.0|26.96|39.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||39.28|26.96|
71737566|NCT00930553|142988976|SUPERIORITY_OR_OTHER||Percentage with SRD|42.46|||||TWO_SIDED|95.0|37.08|48.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||48.28|37.08|
71737567|NCT00930553|142988977|SUPERIORITY_OR_OTHER||Percentage with SRD|16.92|||||TWO_SIDED|95.0|9.75|28.47|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||28.47|9.75|
71737568|NCT00930553|142988977|SUPERIORITY_OR_OTHER||Percentage with SRD|13.89|||||TWO_SIDED|95.0|8.47|22.33|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.|||22.33|8.47|
71737569|NCT04042909|142989019|SUPERIORITY||beta coefficient|-0.309|STANDARD_ERROR_OF_MEAN|0.69||0.646|TWO_SIDED|95.0|-1.632|1.013||This is the p-value of the CAA vs AO factor in the model.|Regression, Linear|We used linear regression, controlling for baseline value of outcome and sex, to determine change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol consumption (drinks per week) from baseline to 6-months.||1.013|-1.632|.646
71660467|NCT03056157|142835068|SUPERIORITY||Slope|-0.04||||0.94|TWO_SIDED|95.0|-1.0|0.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = -0.08, d = 0.02.||0.92|-1.00|0.94
71660468|NCT03056157|142835068|SUPERIORITY||Slope|0.57||||0.23|TWO_SIDED|95.0|-0.35|1.48|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for QDS scores, t(114) = 1.21, d = 0.23.||1.48|-0.35|0.23
71660469|NCT03056157|142835069|SUPERIORITY||Slope|3.98||||0.01|TWO_SIDED|95.0|0.83|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 2.49, d = 0.28.||7.13|0.83|0.01
71660470|NCT03056157|142835069|SUPERIORITY||Slope|4.84|||<|0.001|TWO_SIDED|95.0|2.55|7.13|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 4.16, d = 0.78.||7.13|2.55|<0.001
71660471|NCT03056157|142835069|SUPERIORITY||Slope|0.85||||0.44|TWO_SIDED|95.0|-1.31|3.02|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(114) = 0.78, d = 0.15.||3.02|-1.31|0.44
71737570|NCT04042909|142989020|SUPERIORITY||beta coefficient|-1.9|STANDARD_ERROR_OF_MEAN|0.77||0.014|TWO_SIDED|95.0|-3.41|-0.39|||Regression, Linear|We used regression, controlling for baseline value of outcome and sex, to determine pre-post change in the outcome as a function of condition.||Our main hypothesis is that, relative to Assessment-Only control, the Counter Attitudinal Advocacy intervention will decrease alcohol problems from baseline to 6-months.||-0.39|-3.41|.014
71833227|NCT00567489|143171082|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
71833228|NCT00567489|143171083|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
71833229|NCT00567489|143171083|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
71833230|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
71833231|NCT00567489|143171085|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
71833232|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
71737571|NCT00286494|142989021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.28||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.28|-0.67|<0.001
71739234|NCT02218008|142991200|SUPERIORITY|Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Least Squares Mean Difference|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2||ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Mixed Models Analysis||Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.||-0.2|-3.6|0.026
71833233|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
71833234|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
71660472|NCT03056157|142835069|SUPERIORITY||Slope|0.21||||0.88|TWO_SIDED|95.0|-2.32|2.75|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.17, d = 0.02.||2.75|-2.32|0.88
71833235|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
71833236|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
71833237|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
71833238|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
71660473|NCT03056157|142835069|SUPERIORITY||Slope|0.55||||0.55|TWO_SIDED|95.0|-1.27|2.37|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.60, d = 0.07.||2.37|-1.27|0.55
71660474|NCT03056157|142835069|SUPERIORITY||Slope|0.38||||0.7|TWO_SIDED|95.0|-1.42|2.1|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCS scores, t(316) = 0.38, d = 0.04.||2.10|-1.42|0.70
71660475|NCT03056157|142835070|SUPERIORITY||Slope|-0.04||||0.8|TWO_SIDED|95.0|-0.32|0.25|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(318) = -0.25, d = 0.03.||0.25|-0.32|0.80
71660476|NCT03056157|142835070|SUPERIORITY||Slope|0.04||||0.57|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = 0.57, d = 0.11.||0.16|-0.09|0.57
71737572|NCT00286494|142989021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.8|-0.41||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per protocol criteria.||-0.41|-0.80|<0.001
71737573|NCT00286494|142989022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.36|-0.16||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.36|<0.001
71737574|NCT00286494|142989022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.21|-0.41|<0.001
71737575|NCT00286494|142989023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.56|-0.27||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.27|-0.56|<0.001
71737576|NCT00286494|142989023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.69|<0.001
71737577|NCT00286494|142989024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.30|-0.63|<0.001
71737578|NCT00286494|142989024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.75|-0.43||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.43|-0.75|<0.001
71737579|NCT00286494|142989025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||<|0.001|TWO_SIDED|95.0|-0.63|-0.26||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.63|<0.001
71737580|NCT00286494|142989025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.40|-0.76|<0.001
71737581|NCT00286494|142989026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.6|-0.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.22|-0.60|<0.001
71833239|NCT00567489|143171085|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
71833240|NCT00567489|143171086|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
71660477|NCT03056157|142835070|SUPERIORITY||Slope|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(115) = -0.23, d = 0.04.||0.11|-0.14|0.82
71737582|NCT00286494|142989026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.74|-0.36||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.74|<0.001
71737583|NCT00286494|142989027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.4||||0.003|TWO_SIDED|95.0|-18.9|-3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.9|-18.9|0.003
71833241|NCT00567489|143171086|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
71660478|NCT03056157|142835070|SUPERIORITY||Slope|0.05||||0.57|TWO_SIDED|95.0|-0.13|0.23|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for SCBSC scores, t(320) = 0.57, d = 0.06.||0.23|-0.13|0.57
71660479|NCT03056157|142835071|SUPERIORITY||Slope|3.91||||0.002|TWO_SIDED|95.0|1.48|6.35|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 3.16, d = 0.32.||6.35|1.48|0.002
71660480|NCT03056157|142835071|SUPERIORITY||Slope|4.16|||<|0.001|TWO_SIDED|95.0|2.41|5.92|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 4.66, d = 0.85.||5.92|2.41|<0.001
71737584|NCT00286494|142989027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-23.0|-8.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.0|-23.0|<0.001
71737585|NCT00286494|142989028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|||<|0.001|TWO_SIDED|95.0|-26.4|-11.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.9|-26.4|<0.001
71737586|NCT00286494|142989028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|||<|0.001|TWO_SIDED|95.0|-26.6|-12.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.3|-26.6|<0.001
71737587|NCT00286494|142989029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.6|||<|0.001|TWO_SIDED|95.0|-27.5|-13.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.6|-27.5|<0.001
71737588|NCT00286494|142989029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|||<|0.001|TWO_SIDED|95.0|-29.9|-16.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-16.0|-29.9|<0.001
71737589|NCT00286494|142989030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.5|||<|0.001|TWO_SIDED|95.0|-24.4|-8.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.7|-24.4|<0.001
71737590|NCT00286494|142989030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.1|||<|0.001|TWO_SIDED|95.0|-28.9|-13.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-13.3|-28.9|<0.001
71737591|NCT00286494|142989031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.011|TWO_SIDED|95.0|-18.5|-2.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.4|-18.5|0.011
71833242|NCT00567489|143171086|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
71833243|NCT00567489|143171086|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
71833244|NCT00567489|143171086|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
71833245|NCT00567489|143171086|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
71833246|NCT00567489|143171087|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
71890007|NCT03417440|143301874|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|1.1||0.78|ONE_SIDED|90.0|-0.5|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.5|0.78
71890008|NCT03417440|143301874|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_DEVIATION|1.1||0.98|ONE_SIDED|90.0|-0.7|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.7|0.98
71660481|NCT03056157|142835071|SUPERIORITY||Slope|0.25||||0.78|TWO_SIDED|95.0|-1.44|1.94|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(121) = 0.63, d = 0.11.||1.94|-1.44|0.78
71660482|NCT03056157|142835071|SUPERIORITY||Slope|-0.05||||0.73|TWO_SIDED|95.0|-0.34|0.24|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = -0.34, d = 0.01.||0.24|-0.34|0.73
71660483|NCT03056157|142835071|SUPERIORITY||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.15|0.27|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 0.56, d = 0.06.||0.27|-0.15|0.58
71660484|NCT03056157|142835071|SUPERIORITY||Slope|0.11||||0.28|TWO_SIDED|95.0|-0.1|0.31|||Mixed Models Analysis|||In a mixed model analysis of intent-to-treat data for VLQ scores, t(408) = 1.07, d = 0.11.||0.31|-0.10|0.28
71660485|NCT00806286|142835072|SUPERIORITY||Mean Difference (Final Values)|-23.2|||<|0.0001|TWO_SIDED|||||Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
71660486|NCT00806286|142835072|SUPERIORITY||Cox Proportional Hazard|1.579||||0.0499|TWO_SIDED|95.0|1.0|2.5|||Regression, Cox|||||2.5|1.0|0.0499
71660487|NCT00806286|142835073|SUPERIORITY|Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Mean Difference (Final Values)|-25.5|||<|0.0001|TWO_SIDED||||||Z-test||The estimated value represents the difference in treatments (%).|||||<0.0001
71660488|NCT03469336|142835082|OTHER|Ratio|Mean Ratio (Test/Reference)|1.0109|STANDARD_ERROR_OF_MEAN|0.732||0.9883|TWO_SIDED|95.0|0.2364|4.3226|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.3226|0.2364|0.9883
71737592|NCT00286494|142989031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|||<|0.001|TWO_SIDED|95.0|-24.3|-8.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-24.3|<0.001
71737593|NCT00286494|142989032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||0.029|TWO_SIDED|95.0|-18.9|-1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-18.9|0.029
71737594|NCT00286494|142989032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4||||0.002|TWO_SIDED|95.0|-23.3|-5.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.5|-23.3|0.002
71660489|NCT03469336|142835082|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.732||0.9977|TWO_SIDED|95.0|0.2334|4.2671|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.2671|0.2334|0.9977
71737595|NCT00286494|142989033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||<|0.001|TWO_SIDED|95.0|-24.2|-6.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-24.2|<0.001
71737596|NCT00286494|142989033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.7|-23.8|<0.001
71737597|NCT00286494|142989034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.003|TWO_SIDED|95.0|-23.1|-4.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-4.8|-23.1|0.003
71737598|NCT00286494|142989034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.1||||0.003|TWO_SIDED|95.0|-23.3|-5.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-5.0|-23.3|0.003
71660490|NCT03469336|142835082|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1382|STANDARD_ERROR_OF_MEAN|0.732||0.86|TWO_SIDED|95.0|0.2662|4.867|||Mixed Models Analysis|||The efficacy assessment of PF-06763809 was performed for the change from baseline in log of the psoriatic skin infiltrate thickness/EPB on Day 19 using a longitudinal analysis of covariance model, with treatment, visit, treatment by visit interaction as main effects and the log of the psoriatic skin infiltrate thickness/EPB at baseline as covariate.||4.8670|0.2662|0.8600
71660491|NCT03469336|142835087|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9979|STANDARD_ERROR_OF_MEAN|0.071||0.9763|TWO_SIDED|95.0|0.8588|1.1594|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.1594|0.8588|0.9763
71660492|NCT03469336|142835087|OTHER|Ratio|Mean Ratio (Test/Reference)|0.9664|STANDARD_ERROR_OF_MEAN|0.051||0.5081|TWO_SIDED|95.0|0.8686|1.0752|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.0752|0.8686|0.5081
71660493|NCT03469336|142835087|OTHER|Ratio|Mean Ratio (Test/Reference)|1.1155|STANDARD_ERROR_OF_MEAN|0.044||0.0249|TWO_SIDED|95.0|1.0157|1.2252|||Mixed Models Analysis|||To evaluate the AUC of psoriatic skin infiltrate thickness/EPB for PF-06763809 compared to vehicle.||1.2252|1.0157|0.0249
71660494|NCT03469336|142835088|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7946|STANDARD_ERROR_OF_MEAN|0.732||0.754|TWO_SIDED|95.0|0.1858|3.3977|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3977|0.1858|0.7540
71660495|NCT03469336|142835088|OTHER|Ratio|Mean Ratio (Test/Reference)|0.7844|STANDARD_ERROR_OF_MEAN|0.732||0.7407|TWO_SIDED|95.0|0.1834|3.354|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.3540|0.1834|0.7407
71737599|NCT00286494|142989035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.271|||<|0.001|TWO_SIDED|95.0|0.147|0.499||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.499|0.147|<0.001
71737600|NCT00286494|142989035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.235|||<|0.001|TWO_SIDED|95.0|0.126|0.438||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.438|0.126|<0.001
71737601|NCT00286494|142989036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.628||||0.266|TWO_SIDED|95.0|0.277|1.425||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.425|0.277|0.266
71737602|NCT00286494|142989036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.658||||0.315|TWO_SIDED|95.0|0.292|1.487|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.487|0.292|0.315
71737603|NCT00286494|142989037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4||||0.003|TWO_SIDED|95.0|-10.6|-2.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.1|-10.6|0.003
71737604|NCT00286494|142989037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.023|TWO_SIDED|95.0|-9.1|-0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.7|-9.1|0.023
71737605|NCT00286494|142989038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.043|TWO_SIDED|95.0|-8.3|-0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-8.3|0.043
71737606|NCT00286494|142989038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.489|TWO_SIDED|95.0|-5.5|2.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.6|-5.5|0.489
71737607|NCT00286494|142989039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.068|TWO_SIDED|95.0|-8.8|0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.3|-8.8|0.068
71737608|NCT00286494|142989039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.056|TWO_SIDED|95.0|-8.9|0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.1|-8.9|0.056
71737609|NCT00286494|142989040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-4.9|4.2||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.2|-4.9|0.884
71737610|NCT00286494|142989040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-4.5|4.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-4.5|0.993
71737611|NCT00286494|142989041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.009|TWO_SIDED|95.0|-9.4|-1.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.3|-9.4|0.009
71737612|NCT00286494|142989041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.143|TWO_SIDED|95.0|-7.0|1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.0|-7.0|0.143
71774517|NCT05419908|143049013|SUPERIORITY||LSMean difference|0.0||||0.884|TWO_SIDED|95.0|-0.1|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Lost||0.1|-0.1|0.884
71774518|NCT05419908|143049013|SUPERIORITY||LSMean difference|-0.2||||0.124|TWO_SIDED|95.0|-0.4|0.1||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Lost||0.1|-0.4|0.124
71774519|NCT05419908|143049013|SUPERIORITY||LSMean difference|-0.9||||0.052|TWO_SIDED|95.0|-1.8|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 4: Days Unproductive||0.0|-1.8|0.052
71737613|NCT00286494|142989042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.08|TWO_SIDED|95.0|-8.6|0.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.5|-8.6|0.080
71737614|NCT00286494|142989042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.782|TWO_SIDED|95.0|-5.2|3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.9|-5.2|0.782
71737615|NCT00286494|142989043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.249|TWO_SIDED|95.0|-2.68|0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.70|-2.68|0.249
71737616|NCT00286494|142989043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.303|TWO_SIDED|95.0|-2.56|0.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.80|-2.56|0.303
71737617|NCT00286494|142989044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.478|TWO_SIDED|95.0|-2.46|1.15||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.15|-2.46|0.478
71660496|NCT03469336|142835088|OTHER|Ratio|Mean Ratio (Test/Reference)|0.8946|STANDARD_ERROR_OF_MEAN|0.732||0.8793|TWO_SIDED|95.0|0.2092|3.8256|||Mixed Models Analysis|||The effect of PF-06763809 compared to calcipotriene/calcipotriol solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||3.8256|0.2092|0.8793
71737618|NCT00286494|142989044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.674|TWO_SIDED|95.0|-1.41|2.17||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.17|-1.41|0.674
71737619|NCT00286494|142989045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.743|TWO_SIDED|95.0|-2.18|3.06||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.06|-2.18|0.743
71737620|NCT00286494|142989045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.662|TWO_SIDED|95.0|-3.18|2.02||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.02|-3.18|0.662
71737621|NCT00286494|142989046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75||||0.39|TWO_SIDED|95.0|-0.96|2.45||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.45|-0.96|0.390
71737622|NCT00286494|142989046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.423|TWO_SIDED|95.0|-1.0|2.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.38|-1.00|0.423
71737623|NCT00286494|142989047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.807|TWO_SIDED|95.0|-1.87|1.46||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|-1.87|0.807
71737624|NCT00286494|142989047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.867|TWO_SIDED|95.0|-1.79|1.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.51|-1.79|0.867
71774520|NCT05419908|143049013|SUPERIORITY||LSMean difference|-0.9||||0.06||95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 8: Days Unproductive||0.0|-1.7|0.060
71660497|NCT03469336|142835089|OTHER|Ratio|Mean Ratio (Test/Reference)|1.081321|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.25287|4.623941|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.623941|0.25287|<0.0001
71660498|NCT03469336|142835089|OTHER|Ratio|Mean Ratio (Test/Reference)|1.067453|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.249631|4.564555|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||4.564555|0.249631|<0.0001
71660499|NCT03469336|142835089|OTHER|Ratio|Mean Ratio (Test/Reference)|1.217483|STANDARD_ERROR_OF_MEAN|0.732|<|0.0001|TWO_SIDED|95.0|0.284708|5.206258|||Mixed Models Analysis|||The effect of PF-06763809 compared to betamethasone solution in the change of psoriatic skin infiltrate thickness/EPB on Day 19.||5.206258|0.284708|<0.0001
71660500|NCT02109419|142835090|OTHER||Pearson Test-retest reliability coeff.|0.8|||<|0.0001|TWO_SIDED||||||Pearson Test-retest reliability coeff.|||HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
71660501|NCT02109419|142835090|OTHER||Pearson test-retest reliability coeff|0.87|||<|0.0001|TWO_SIDED||||||Pearson test-retest reliability coeff|||HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.||||<0.0001
71660502|NCT02109419|142835090|OTHER||Pearson correlation coefficient|0.6|||<|0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.||||<.0001
71660503|NCT02109419|142835090|OTHER||Pearson correlation coefficient|0.71||||0.0001|TWO_SIDED||||||Pearson correlation coefficient|||Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.||||0.0001
71660504|NCT02109419|142835090|OTHER||Chronbach's alpha|0.73|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
71660505|NCT02109419|142835090|OTHER||Chronbach's alpha|0.7|||||TWO_SIDED|||||||||Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.||||
71660506|NCT03560986|142835126|SUPERIORITY||Mean Difference (Net)|0.43|STANDARD_ERROR_OF_MEAN|0.372||0.2522|TWO_SIDED|95.0|-0.31|1.17||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||1.17|-0.31|0.2522
71660507|NCT00593736|142835140|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.||||0.646
71660508|NCT00593736|142835140|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.084
71660509|NCT00593736|142835140|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.929
71660510|NCT00593736|142835141|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.854
71660511|NCT00593736|142835141|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.383
71660512|NCT00593736|142835141|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.883
71660513|NCT00593736|142835142|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
71660514|NCT00593736|142835142|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
71660515|NCT00593736|142835142|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.269
71737625|NCT00286494|142989048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.483|TWO_SIDED|95.0|-1.1|2.33||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.33|-1.10|0.483
71737626|NCT00286494|142989048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.352|TWO_SIDED|95.0|-0.89|2.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.51|-0.89|0.352
71737627|NCT00286494|142989049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.001|TWO_SIDED|95.0|-0.092|-0.022||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.022|-0.092|0.001
71737628|NCT00286494|142989049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.001|TWO_SIDED|95.0|-0.093|-0.024||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.093|0.001
71737629|NCT00286494|142989050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049||||0.006|TWO_SIDED|95.0|-0.084|-0.014||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.014|-0.084|0.006
71737630|NCT00286494|142989050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.004|TWO_SIDED|95.0|-0.086|-0.016||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.016|-0.086|0.004
71737631|NCT00286494|142989051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.05|TWO_SIDED|95.0|-0.092|0.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.000|-0.092|0.050
71737632|NCT00286494|142989051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057||||0.014|TWO_SIDED|95.0|-0.102|-0.012||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.102|0.014
71737633|NCT00286494|142989052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027||||0.144|TWO_SIDED|95.0|-0.064|0.009||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.064|0.144
71737634|NCT00286494|142989052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.105|TWO_SIDED|95.0|-0.067|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.067|0.105
71737635|NCT00286494|142989053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059||||0.004|TWO_SIDED|95.0|-0.1|-0.019||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.100|0.004
71737636|NCT00286494|142989053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.012|TWO_SIDED|95.0|-0.092|-0.011||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.011|-0.092|0.012
71737637|NCT00286494|142989054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.028|TWO_SIDED|95.0|-0.095|-0.005||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.005|-0.095|0.028
71737638|NCT00286494|142989054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.093|TWO_SIDED|95.0|-0.082|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.006|-0.082|0.093
71737639|NCT00286494|142989055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.928|TWO_SIDED|95.0|-0.28|0.255||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.255|-0.280|0.928
71833247|NCT00567489|143171087|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
71660516|NCT00593736|142835143|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.920
71737640|NCT00286494|142989055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056||||0.683|TWO_SIDED|95.0|-0.212|0.324||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.324|-0.212|0.683
71737641|NCT00286494|142989056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.967|TWO_SIDED|95.0|-0.277|0.265||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.265|-0.277|0.967
71737642|NCT00286494|142989056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135||||0.327|TWO_SIDED|95.0|-0.135|0.405||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.405|-0.135|0.327
71737643|NCT00286494|142989057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068||||0.649|TWO_SIDED|95.0|-0.363|0.226||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.226|-0.363|0.649
71737644|NCT00286494|142989057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051||||0.735|TWO_SIDED|95.0|-0.344|0.243||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.243|-0.344|0.735
71737645|NCT00286494|142989058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.114|TWO_SIDED|95.0|-0.053|0.492||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.492|-0.053|0.114
71660517|NCT00593736|142835143|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.382
71660518|NCT00593736|142835143|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.439
71737646|NCT00286494|142989058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.086|TWO_SIDED|95.0|-0.033|0.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.510|-0.033|0.086
71737647|NCT00286494|142989059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.835|TWO_SIDED|95.0|-0.221|0.273||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.273|-0.221|0.835
71737648|NCT00286494|142989059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131||||0.296|TWO_SIDED|95.0|-0.115|0.378||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.378|-0.115|0.296
71737649|NCT00286494|142989060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123||||0.349|TWO_SIDED|95.0|-0.134|0.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.380|-0.134|0.349
71737650|NCT00286494|142989060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223||||0.089|TWO_SIDED|95.0|-0.034|0.479||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.479|-0.034|0.089
71737651|NCT00286494|142989061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.815||||0.003|TWO_SIDED|95.0|1.736|13.358|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||13.358|1.736|0.003
71774521|NCT05419908|143049013|SUPERIORITY||LSMean difference|-0.8||||0.049|TWO_SIDED|95.0|-1.7|0.0||Least square mean difference versus placebo, obtained from an ANCOVA model with treatment group as fixed effect and baseline SDS as covariate.|ANCOVA|||Week 12: Days Unproductive||0.0|-1.7|0.049
71660519|NCT00593736|142835144|SUPERIORITY_OR_OTHER|||||||0.973||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.973
71833248|NCT00567489|143171087|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
71833249|NCT00567489|143171087|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
71833250|NCT00567489|143171088|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
71833251|NCT00567489|143171088|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
71833252|NCT00567489|143171089|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
71833253|NCT00567489|143171090|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
71890009|NCT03417440|143301874|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.1||0.13|ONE_SIDED|90.0|-0.1|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.1|0.13
71890010|NCT03417440|143301875|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|4.3||0.285|ONE_SIDED|90.0||0.6||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||0.6||0.285
71660520|NCT00593736|142835144|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
71660521|NCT00593736|142835144|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.816
71737652|NCT00286494|142989061|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533|||<|0.001|TWO_SIDED|95.0|2.017|15.176|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||15.176|2.017|<0.001
71833254|NCT00567489|143171090|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
71833255|NCT00567489|143171090|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
71833256|NCT00567489|143171090|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
71833257|NCT00567489|143171091|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
71890011|NCT03417440|143301875|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|4.3||0.5|ONE_SIDED|90.0||1.1||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||1.1||0.50
71890012|NCT03417440|143301875|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|4.3||0.92|ONE_SIDED|90.0||2.3||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided|||||2.3||0.92
71660522|NCT00593736|142835145|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.661
71774522|NCT05098938|143049034|SUPERIORITY|||||||0.716|||||||Log Rank|||||||0.716
71774523|NCT05098938|143049035|SUPERIORITY|||||||0.102|||||||Chi-squared|||||||0.102
71774524|NCT05098938|143049036|SUPERIORITY|||||||0.712|||||||Chi-squared|||||||0.712
71774525|NCT05098938|143049037|SUPERIORITY|||||||0.575|||||||Log Rank|||||||0.575
71833258|NCT00567489|143171091|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
71833259|NCT00567489|143171091|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
71833260|NCT00567489|143171091|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
71833261|NCT00567489|143171092|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
71833262|NCT00567489|143171092|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
71833263|NCT00567489|143171093|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
71833264|NCT00567489|143171093|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
71737653|NCT00286494|142989062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.029|TWO_SIDED|95.0|1.067|3.393|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.393|1.067|0.029
71737654|NCT00286494|142989062|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.301||||0.005|TWO_SIDED|95.0|1.291|4.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regiment \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.100|1.291|0.005
71737655|NCT00286494|142989063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.783|||<|0.001|TWO_SIDED|95.0|1.547|5.005|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.005|1.547|<0.001
71737656|NCT00286494|142989063|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.917|||<|0.001|TWO_SIDED|95.0|2.147|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.147|<0.001
71737657|NCT00286494|142989064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.134|||<|0.001|TWO_SIDED|95.0|2.392|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.146|2.392|<0.001
71737658|NCT00286494|142989064|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.247|||<|0.001|TWO_SIDED|95.0|3.027|9.094|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.094|3.027|<0.001
71737659|NCT00286494|142989065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|1.789|7.532|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||7.532|1.789|<0.001
71737660|NCT00286494|142989065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.693|||<|0.001|TWO_SIDED|95.0|2.303|9.56|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||9.560|2.303|<0.001
71737661|NCT00286494|142989066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.8||||0.015|TWO_SIDED|95.0|1.3|11.107|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.107|1.300|0.015
71737662|NCT00286494|142989066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.196||||0.002|TWO_SIDED|95.0|1.806|14.95|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||14.950|1.806|0.002
71737663|NCT00286494|142989067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.959||||0.364|TWO_SIDED|95.0|0.459|8.362|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||8.362|0.459|0.364
71737664|NCT00286494|142989067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.849||||0.146|TWO_SIDED|95.0|0.696|11.672|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen \& baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||11.672|0.696|0.146
71737665|NCT00286494|142989068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.718|TWO_SIDED|95.0|-0.45|0.65||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.65|-0.45|0.718
71774526|NCT03437512|143049052|SUPERIORITY||||||<|0.001||||||familywise error rate (FWE) corrected to .05 with cluster threshold of 80 voxels.|t-test, 2 sided|||||||<.001
71774527|NCT03437512|143049053|SUPERIORITY|||||||0.936||||||Interaction between visit and group.|ANOVA|||Analyses conduced with a mixed ANOVA, with between-subjects factor of group (active, sham) and two within-subjects factors: time (post, follow up) and speech task (reading, conversation).||||.936
71737666|NCT00286494|142989068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.906|TWO_SIDED|95.0|-0.52|0.58||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.58|-0.52|0.906
71737667|NCT00286494|142989069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.672|TWO_SIDED|95.0|-0.5|0.78||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.78|-0.50|0.672
71774528|NCT03437512|143049054|SUPERIORITY|||||||0.619||||||Interaction between visit and group.|ANOVA|||||||.619
71774529|NCT02360995|143049128|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.652
71774530|NCT02360995|143049129|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71660523|NCT00593736|142835145|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.341
71660524|NCT00593736|142835145|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
71660525|NCT00593736|142835146|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.365
71660526|NCT00593736|142835146|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.121
71833265|NCT00567489|143171094|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
71833266|NCT00567489|143171094|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
71660527|NCT00593736|142835146|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.268
71660528|NCT00593736|142835147|SUPERIORITY_OR_OTHER|||||||0.9||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.900
71660529|NCT00593736|142835147|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.525
71660530|NCT00593736|142835147|SUPERIORITY_OR_OTHER|||||||0.418||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.418
71660531|NCT00593736|142835148|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.051
71774531|NCT02360995|143049130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71774532|NCT02360995|143049131|SUPERIORITY_OR_OTHER|||||||0.533|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.533
71774533|NCT02360995|143049132|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71774534|NCT02360995|143049133|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71774535|NCT02611960|143049134|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2262|TWO_SIDED|95.0|0.67|1.19||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.19|0.67|0.2262
71833267|NCT00567489|143171095|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
71833268|NCT00567489|143171096|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
71833269|NCT00567489|143171096|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
71833270|NCT00567489|143171096|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
71833271|NCT00567489|143171096|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
71833272|NCT00567489|143171097|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
71737668|NCT00286494|142989069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.922|TWO_SIDED|95.0|-0.61|0.67||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.67|-0.61|0.922
71737669|NCT00286494|142989070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.607|TWO_SIDED|95.0|-0.56|0.96||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.96|-0.56|0.607
71737670|NCT00286494|142989070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.985|TWO_SIDED|95.0|-0.77|0.76||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.76|-0.77|0.985
71737671|NCT00286494|142989071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.294|TWO_SIDED|95.0|-0.37|1.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.22|-0.37|0.294
71737672|NCT00286494|142989071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.9|TWO_SIDED|95.0|-0.74|0.84||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.84|-0.74|0.900
71737673|NCT01457846|142989214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.57||||0.9581|TWO_SIDED|80.0|1.12|2.21||1-sided|Regression, Cox|||||2.21|1.12|0.9581
71737674|NCT01457846|142989215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.8156|TWO_SIDED|80.0|0.89|1.95||1-sided|Regression, Cox|||||1.95|0.89|0.8156
71737675|NCT01457846|142989216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.997|TWO_SIDED|80.0|0.02|0.35||1-sided|Regression, Logistic|||||0.35|0.02|0.9970
71737676|NCT03202134|142989240|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71737677|NCT03202134|142989241|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71737678|NCT03202134|142989242|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71737679|NCT03202134|142989243|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71737680|NCT03202134|142989244|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
71737681|NCT00966550|142989246|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
71737682|NCT01128946|142989255|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.06|||<|0.0001|TWO_SIDED|95.0|19.63|26.48||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||26.48|19.63|<0.0001
71737683|NCT01128946|142989256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.75|||<|0.0001|TWO_SIDED|95.0|7.33|14.17||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.17|7.33|<0.0001
71737684|NCT01128946|142989256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|8.74|15.67||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.67|8.74|<0.0001
71774536|NCT02611960|143049135|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.9419|TWO_SIDED|95.0|0.94|1.75||One-sided p-value based on log-rank test stratified by presence of liver metastasis.|Stratified Log-Rank Test|||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis.||1.75|0.94|0.9419
71774537|NCT02611960|143049136|SUPERIORITY||Difference in Percentage|-1.9||||0.63479|TWO_SIDED|95.0|-12.7|8.9||One-sided p-value for testing. H0: difference in percentage = 0 versus H1: difference in percentage \> 0.|Stratified Miettinen and Nurminen Method|||Comparison based on Miettinen \& Nurminen method stratified by presence of liver metastasis.||8.9|-12.7|0.63479
71774538|NCT04622735|143049178|SUPERIORITY|||||||0.0031|||||||Mixed Models Analysis|||||||0.0031
71774539|NCT04622735|143049178|SUPERIORITY|||||||0.6787|||||||Mixed Models Analysis|||||||0.6787
71774540|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.375
71774541|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.156
71774542|NCT01325623|143049223|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months||||>0.999
71774543|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.906
71660532|NCT00593736|142835148|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.926
71737685|NCT01128946|142989256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.31|||<|0.0001|TWO_SIDED|95.0|8.9|15.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.72|8.90|<0.0001
71737686|NCT01128946|142989256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.46||||0.407|TWO_SIDED|95.0|-2.0|4.91||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||4.91|-2.00|0.4070
71737687|NCT01128946|142989256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.85|||<|0.0001|TWO_SIDED|95.0|-14.3|-7.4||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-7.40|-14.30|<0.0001
71737688|NCT01128946|142989257|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.21|||<|0.0001|TWO_SIDED|95.0|11.46|14.96||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||14.96|11.46|<0.0001
71737689|NCT01128946|142989257|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.79|||<|0.0001|TWO_SIDED|95.0|7.04|10.55||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||10.55|7.04|<0.0001
71737690|NCT01128946|142989257|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.03|||<|0.0001|TWO_SIDED|95.0|6.25|9.8||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||9.80|6.25|<0.0001
71737691|NCT01128946|142989257|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.41|||<|0.0001|TWO_SIDED|95.0|2.66|6.16||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||6.16|2.66|<0.0001
71737692|NCT01128946|142989257|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.3942|TWO_SIDED|95.0|-2.54|1.0||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||1.00|-2.54|0.3942
71737693|NCT01128946|142989257|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.18|||<|0.0001|TWO_SIDED|95.0|-6.95|-3.41||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.||-3.41|-6.95|<0.0001
71737694|NCT01371734|142989258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.587|TWO_SIDED|95.0|-2.23|3.94|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||3.94|-2.23|0.587
71774544|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
71660533|NCT00593736|142835148|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.166
71737695|NCT01371734|142989258|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52||||0.333|TWO_SIDED|95.0|-1.56|4.61|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||4.61|-1.56|0.333
71737696|NCT01371734|142989259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.923|TWO_SIDED|95.0|-0.29|0.32|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose||0.32|-0.29|0.923
71737697|NCT01371734|142989259|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.161||||0.302|TWO_SIDED|95.0|-0.14|0.47|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose||0.47|-0.14|0.302
71737698|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.729|||||||Cochran-Mantel-Haenszel|||Week 1||||0.729
71737699|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.756|||||||Cochran-Mantel-Haenszel|||Week 1||||0.756
71737700|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.765|||||||Cochran-Mantel-Haenszel|||Week 2||||0.765
71737701|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 2||||0.475
71774545|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.906
71774546|NCT01325623|143049223|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||<0.001
71833273|NCT00567489|143171097|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
71737702|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.31|||||||Cochran-Mantel-Haenszel|||Week 3||||0.310
71737703|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.105|||||||Chi-squared, Corrected|||Week 3||||0.105
71737704|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.254|||||||Cochran-Mantel-Haenszel|||Week 4||||0.254
71774547|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||0.106
71774548|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.012
71774549|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.008
71774550|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.009
71890302|NCT03952559|143302134|SUPERIORITY||LS Mean difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.647||0.2987|TWO_SIDED|95.0|-1.93|0.59|||Mixed Models Analysis|||||0.59|-1.93|0.2987
71737705|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.887|||||||Cochran-Mantel-Haenszel|||Week 4||||0.887
71737706|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 6||||0.475
71737707|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 6||||0.407
71737708|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.696|||||||Cochran-Mantel-Haenszel|||Week 8||||0.696
71737709|NCT01371734|142989260|SUPERIORITY_OR_OTHER|||||||0.462|||||||Cochran-Mantel-Haenszel|||Week 8||||0.462
71737710|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.806||||0.633|TWO_SIDED|95.0|0.333|1.951|||Regression, Logistic|||Week 1||1.951|0.333|0.633
71737711|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.172|TWO_SIDED|95.0|0.245|1.285|||Regression, Logistic|||Week 1||1.285|0.245|0.172
71737712|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.939||||0.826|TWO_SIDED|95.0|0.536|1.644|||Regression, Logistic|||Week 2||1.644|0.536|0.826
71737713|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.599|TWO_SIDED|95.0|0.489|1.511|||Regression, Logistic|||Week 2||1.511|0.489|0.599
71737714|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.713||||0.248|TWO_SIDED|95.0|0.402|1.265|||Regression, Logistic|||Week 3||1.265|0.402|0.248
71737715|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.564||||0.048|TWO_SIDED|95.0|0.32|0.995|||Regression, Logistic|||Week 3||0.995|0.320|0.048
71737716|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.21|TWO_SIDED|95.0|0.412|1.216|||Regression, Logistic|||Week 4||1.216|0.412|0.210
71737717|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.964||||0.893|TWO_SIDED|95.0|0.564|1.646|||Regression, Logistic|||Week 4||1.646|0.564|0.893
71737718|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.714||||0.228|TWO_SIDED|95.0|0.413|1.235|||Regression, Logistic|||Week 6||1.235|0.413|0.228
71737719|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.751|TWO_SIDED|95.0|0.531|1.579|||Regression, Logistic|||Week 6||1.579|0.531|0.751
71737720|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.974||||0.925|TWO_SIDED|95.0|0.561|1.689|||Regression, Logistic|||Week 8||1.689|0.561|0.925
71774551|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.029
71833274|NCT00567489|143171098|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
71833275|NCT00567489|143171098|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
71833276|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
71833277|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
71833278|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
71833279|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
71833280|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
71890013|NCT03417440|143301876|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|4.2||0.42|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.42
71890014|NCT03417440|143301876|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|4.2||0.82|ONE_SIDED|90.0|-1.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.9|0.82
71890015|NCT03417440|143301876|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_DEVIATION|4.2||0.58|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.58
71737721|NCT01371734|142989261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.764||||0.342|TWO_SIDED|95.0|0.438|1.331|||Regression, Logistic|||Week 8||1.331|0.438|0.342
71737722|NCT00621140|142989262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.85|-0.53|||ANCOVA|||Linagliptin vs. Placebo||-0.53|-0.85|<0.0001
71737723|NCT00621140|142989263|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.58|-0.34|||ANCOVA|||Linagliptin vs. Placebo||-0.34|-0.58|<0.0001
71890016|NCT03417440|143301877|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|4.0||0.45|ONE_SIDED|90.0|-0.9|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-0.9|0.45
71890017|NCT03417440|143301877|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|3.9||0.49|ONE_SIDED|90.0|-1.0|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.0|0.49
71737724|NCT00621140|142989264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.76|-0.47|||ANCOVA|||Linagliptin vs. Placebo||-0.47|-0.76|<0.0001
71737725|NCT00621140|142989265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.82|-0.49|||ANCOVA|||Linagliptin vs. Placebo||-0.49|-0.82|<0.0001
71737726|NCT00621140|142989266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.31|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001||95.0|-30.37|-16.26|||ANCOVA|||Linagliptin vs. Placebo||-16.26|-30.37|<0.0001
71737727|NCT00621140|142989267|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|2.81|<|0.0001||95.0|-23.11|-12.08|||ANCOVA|||Linagliptin vs. Placebo||-12.08|-23.11|<0.0001
71833281|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
71833282|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
71833283|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
71833284|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
71833285|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
71890018|NCT03417440|143301877|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.9||0.61|ONE_SIDED|90.0|-1.2|||a priori threshold for statistical significance=0.1 for 1-sided t-test; no adjustments for multiple comparisons made; if the outcome is not in the hypothesized direction, values that meet or exceed the 0.1 threshold will not be considered significant|t-test, 1 sided||||||-1.2|0.61
71890019|NCT03417440|143301878|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||.84
71890020|NCT03417440|143301878|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
71890021|NCT03417440|143301878|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||.41
71660534|NCT00593736|142835149|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.511
71660535|NCT00593736|142835149|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
71660536|NCT00593736|142835149|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.188
71660537|NCT00593736|142835150|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.691
71660538|NCT00593736|142835150|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.323
71660539|NCT00593736|142835150|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.324
71660540|NCT00593736|142835151|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.197
71660541|NCT00593736|142835151|SUPERIORITY_OR_OTHER|||||||0.871||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.871
71660542|NCT00593736|142835151|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.737
71774552|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
71774553|NCT01325623|143049223|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
71774554|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||0.500
71774555|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.500
71774556|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.188
71774557|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
71774558|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge||||0.500
71774559|NCT01325623|143049223|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months||||>0.999
71660543|NCT00593736|142835152|SUPERIORITY_OR_OTHER|||||||0.972||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.972
71660544|NCT00593736|142835152|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.117
71660545|NCT00593736|142835152|SUPERIORITY_OR_OTHER|||||||0.811||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.811
71660546|NCT00593736|142835153|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.659
71660547|NCT00593736|142835153|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.337
71774560|NCT01325623|143049223|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months||||>0.999
71890022|NCT03417440|143301879|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
71660548|NCT00593736|142835153|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.853
71660549|NCT00593736|142835154|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
71660550|NCT00593736|142835154|SUPERIORITY_OR_OTHER|||||||0.495||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.495
71737728|NCT00621140|142989268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.98|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001||95.0|-27.21|-14.75|||ANCOVA|||Linagliptin vs. Placebo||-14.75|-27.21|<0.0001
71737729|NCT00621140|142989269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.36|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.05|-13.68|||ANCOVA|||Linagliptin vs. Placebo||-13.68|-27.05|<0.0001
71737730|NCT00621140|142989270|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.869||||0.0006||95.0|1.575|5.225|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.225|1.575|0.0006
71737731|NCT00621140|142989272|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.436||||0.0323||95.0|1.078|5.507|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.507|1.078|0.0323
71737732|NCT00621140|142989274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.243|||<|0.0001||95.0|2.665|6.755|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||6.755|2.665|<0.0001
71737733|NCT00621140|142989275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.38|STANDARD_DEVIATION|12.05|<|0.0001||95.0|-82.33|-34.43|||ANCOVA|||Linagliptin vs. Placebo||-34.43|-82.33|<0.0001
71737734|NCT00360568|142989290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71737735|NCT00360568|142989291|SUPERIORITY_OR_OTHER|||||||0.394|||||||t-test, 2 sided|||||||0.394
71833286|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
71660551|NCT00593736|142835154|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.800
71737736|NCT00360568|142989292|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71660552|NCT00593736|142835155|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
71660553|NCT00593736|142835155|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.134
71737737|NCT00360568|142989293|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71737738|NCT00360568|142989294|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||||||0.055
71737739|NCT00360568|142989295|SUPERIORITY_OR_OTHER|||||||0.766|||||||t-test, 2 sided|||||||0.766
71737740|NCT00360568|142989296|SUPERIORITY_OR_OTHER|||||||0.571|||||||t-test, 2 sided|||||||0.571
71737741|NCT00360568|142989297|SUPERIORITY_OR_OTHER|||||||0.583|||||||t-test, 2 sided|||||||0.583
71737742|NCT00360568|142989298|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71737743|NCT00360568|142989299|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
71737744|NCT00360568|142989300|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||||||0.341
71737745|NCT00360568|142989301|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.220
71737746|NCT00360568|142989302|SUPERIORITY_OR_OTHER|||||||0.174|||||||t-test, 2 sided|||||||0.174
71737747|NCT00360568|142989303|SUPERIORITY_OR_OTHER|||||||0.259|||||||t-test, 2 sided|||||||0.259
71737748|NCT00360568|142989304|SUPERIORITY_OR_OTHER|||||||0.922|||||||t-test, 2 sided|||||||0.922
71737749|NCT00360568|142989305|SUPERIORITY_OR_OTHER|||||||0.258|||||||t-test, 2 sided|||||||0.258
71737750|NCT00360568|142989306|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||||||0.104
71737751|NCT00360568|142989307|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.650
71737752|NCT00360568|142989308|SUPERIORITY_OR_OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
71737753|NCT00360568|142989309|SUPERIORITY_OR_OTHER|||||||0.459|||||||t-test, 2 sided|||||||0.459
71737754|NCT00360568|142989310|SUPERIORITY_OR_OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
71737755|NCT02467842|142989329|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|1.02|||||TWO_SIDED|95.0|0.94|1.1||||||GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)||1.10|0.94|
71737756|NCT02467842|142989329|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|0.94|||||TWO_SIDED|95.0|0.87|1.01||||||GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)||1.01|0.87|
71737757|NCT02467842|142989329|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.88|||||TWO_SIDED|95.0|0.82|0.95||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.95|0.82|
71833287|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
71890023|NCT03417440|143301879|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
71890024|NCT03417440|143301879|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.39
71737758|NCT02467842|142989329|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.9|||||TWO_SIDED|95.0|0.83|0.97||||||GMR of A/H1N1 strain (GMTs of TIV/QIV)||0.97|0.83|
71737759|NCT02467842|142989330|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-6.07|4.06||||||Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)||4.06|-6.07|
71737760|NCT02467842|142989330|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-5.02|||||TWO_SIDED|95.0|-10.08|0.04||||||Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)||0.04|-10.08|
71737761|NCT02467842|142989330|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-7.06|||||TWO_SIDED|95.0|-13.12|-1.0||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-1.00|-13.12|
71737762|NCT02467842|142989330|NON_INFERIORITY|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-3.09|||||TWO_SIDED|95.0|-9.26|3.09||||||Diff. SCR of B/Victoria (SCR of TIV minus QIV)||3.09|-9.26|
71737763|NCT02467842|142989334|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.7|0.81||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)||0.81|0.70|
71737764|NCT02467842|142989334|SUPERIORITY|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||GMR of B/Victoria (GMTs of TIV/QIV)||0.81|0.69|
71737765|NCT02467842|142989335|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-18.98|||||TWO_SIDED|95.0|-24.61|-13.36||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)||-13.36|-24.61|
71737766|NCT02467842|142989335|SUPERIORITY|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-12.62|||||TWO_SIDED|95.0|-18.79|-6.45||||||Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)||-6.45|-18.79|
71737767|NCT01743040|142989355|NON_INFERIORITY|15% equivalency margin against performance of SPECT nuclear stress test OPC. Both sensitivity and specificity were measured and the equivalency margin was set the same for both parameters.The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||||0.012|||||||Exact binomial test|||The goal was to test the Sensitivity and specificity of CADence as compared to SPECT nuclear stress test OPC. Both were measured and reported in this study. The Sensitivity of CADence was 78% (95% CI 76.1-90.8%) while the specificity was 36% (95% CI 32-39%).||||0.012
71833288|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
71833289|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
71737768|NCT01990612|142989377|SUPERIORITY||Risk Ratio (RR)|0.8||||0.049|TWO_SIDED|95.0|0.64|1.0|||Chi-squared|Group sequential method to control type I error w/ Lan-DeMets characterization of O'Brien-Fleming boundary. 2-tailed p-value \<0.46 considered stat sig|One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.|||1.00|0.64|0.049
71737769|NCT01990612|142989378|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.12|3.33|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.33|0.12|
71737770|NCT01990612|142989379|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.55|0.93||||||||0.93|0.55|
71737771|NCT01990612|142989380|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.32|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.32|
71737772|NCT01990612|142989381|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.35|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.37|0.35|
71737773|NCT01990612|142989382|SUPERIORITY||Risk Ratio (RR)|2.74|||||TWO_SIDED|95.0|0.91|8.12|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||8.12|0.91|
71737774|NCT01990612|142989383|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.31|1.76|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.76|0.31|
71737775|NCT01990612|142989384|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.35|1.19|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.19|0.35|
71833290|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
71833291|NCT00567489|143171099|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
71833292|NCT00567489|143171100|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
71737776|NCT01990612|142989385|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.38|1.55|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.55|0.38|
71833293|NCT00567489|143171100|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
71833294|NCT00567489|143171101|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
71833295|NCT00567489|143171101|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
71833296|NCT00567489|143171102|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
71737777|NCT01990612|142989386|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.48|3.42|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||3.42|0.48|
71737778|NCT01990612|142989387|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.06|1.79|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.|||1.79|0.06|
71737779|NCT01990612|142989388|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.001|TWO_SIDED|95.0|0.76|0.93||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.93|0.76|<0.001
71737780|NCT01990612|142989389|SUPERIORITY||Risk Ratio (RR)|0.58||||0.02|TWO_SIDED|95.0|0.36|0.92||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.92|0.36|0.02
71737781|NCT01990612|142989390|SUPERIORITY||Risk Ratio (RR)|0.85||||0.07|TWO_SIDED|95.0|0.72|1.01|||Chi-squared|||||1.01|0.72|0.07
71737782|NCT01990612|142989391|SUPERIORITY||Risk Ratio (RR)|0.94||||0.35|TWO_SIDED|95.0|0.83|1.07|||Chi-squared|||||1.07|0.83|0.35
71737783|NCT01990612|142989392|SUPERIORITY||Risk Ratio (RR)|1.15||||0.33|TWO_SIDED|95.0|0.87|1.52|||Chi-squared|||||1.52|0.87|0.33
71737784|NCT01990612|142989394|SUPERIORITY||Risk Ratio (RR)|0.5||||0.26|TWO_SIDED|95.0|0.13|1.55|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||1.55|0.13|0.26
71737785|NCT01990612|142989395|SUPERIORITY||Risk Ratio (RR)|0.64|||<|0.001|TWO_SIDED|95.0|0.56|0.74||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||||0.74|0.56|<0.001
71737786|NCT01990612|142989396|SUPERIORITY||Risk Ratio (RR)|1.03||||0.81|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||||1.29|0.82|0.81
71737787|NCT01990612|142989397|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 6-96 hours after delivery||||<0.001
71737788|NCT01990612|142989397|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 4-8 weeks after delivery||||0.01
71737789|NCT01990612|142989398|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Worst labor pain score||||<0.001
71737790|NCT01990612|142989398|SUPERIORITY||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Overall labor pain score||||<0.001
71737791|NCT01990612|142989399|SUPERIORITY||Risk Ratio (RR)|0.76||||0.15|TWO_SIDED|95.0|0.53|1.1|||Chi-squared|||||1.10|0.53|0.15
71737792|NCT01990612|142989400|SUPERIORITY||Risk Ratio (RR)|1.99||||1|TWO_SIDED|95.0|0.26|26.8|||Chi-squared|The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.|Exact confidence intervals are provided for rare outcomes.|||26.8|0.26|1.00
71737793|NCT01990612|142989402|SUPERIORITY|||||||0.01|||||||Cochran-Armitage trend test|||||||0.01
71737794|NCT01990612|142989403|SUPERIORITY||Risk Ratio (RR)|0.92||||0.56|TWO_SIDED|95.0|0.68|1.23|||Chi-squared|||||1.23|0.68|0.56
71737795|NCT01990612|142989404|SUPERIORITY||Risk Ratio (RR)|0.9||||0.56|TWO_SIDED|95.0|0.64|1.28|||Chi-squared|||||1.28|0.64|0.56
71737796|NCT01990612|142989405|SUPERIORITY||Risk Ratio (RR)|0.79||||0.75|TWO_SIDED|95.0|0.2|2.74|||Chi-squared||Exact confidence intervals are provided for rare outcomes.|||2.74|0.20|0.75
71737797|NCT01990612|142989406|SUPERIORITY||Risk Ratio (RR)|1.01||||0.91|TWO_SIDED|95.0|0.81|1.27|||Chi-squared|||||1.27|0.81|0.91
71737798|NCT01990612|142989407|SUPERIORITY||Risk Ratio (RR)|1.05||||0.84|TWO_SIDED|95.0|0.66|1.66|||Chi-squared|||||1.66|0.66|0.84
71737799|NCT01990612|142989408|SUPERIORITY||Risk Ratio (RR)|0.9||||0.13|TWO_SIDED|95.0|0.79|1.03|||Chi-squared|||||1.03|0.79|0.13
71737800|NCT01990612|142989409|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank-Sum|||||||<0.001
71833297|NCT00567489|143171102|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
71833298|NCT00567489|143171103|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
71833299|NCT00539734|143171122|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.||||<0.05
71833300|NCT02570022|143171125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||t-test, 2 sided||This analysis corresponds to the visual analog scale and morphine equivalent data.|Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtained||||<0.05
71737801|NCT01990612|142989410|SUPERIORITY|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.01
71737802|NCT01990612|142989411|SUPERIORITY|||||||0.002||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test|||||||0.002
71737803|NCT01990612|142989413|OTHER||Odds Ratio, log|1.01||||0.88|TWO_SIDED|95.0|0.89|1.15||Odds ratios from multinomial logistic regression.|Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.||1.15|0.89|0.88
71737804|NCT01990612|142989413|OTHER||Odds Ratio, log|0.98||||0.78|TWO_SIDED|95.0|0.86|1.12|||Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.||1.12|0.86|0.78
71737805|NCT00360724|142989424|SUPERIORITY_OR_OTHER||F statistics|9.43||||0.003|||||||Repeated Measures ANOVA|df 1,55|time X Drug group, f=9.43,df 1,55, p=.003|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||.003
71737806|NCT00360724|142989426|SUPERIORITY_OR_OTHER||F statistics|8.72||||0.05|||||||Repeated Measures ANOVA|d.f. 1,55|Time x Treatment: F=8.72, d.f=1,55, p=0.05|Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.05
71737807|NCT00360724|142989427|SUPERIORITY_OR_OTHER||F statistics|5.33||||0.025|||||||Repeated measures ANOVA|d.f. 1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.025
71737808|NCT00360724|142989428|SUPERIORITY_OR_OTHER||F statistics|0.26||||0.6|||||||Repeated measures ANOVA|d.f.=1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.||||0.6
71737809|NCT00360724|142989433|OTHER||Mean Difference (Final Values)|4.0||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71737810|NCT00360724|142989434|OTHER||Mean Difference (Final Values)|0.4||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.9
71774561|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months||||0.125
71833301|NCT00041938|143171127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.4|TWO_SIDED|95.0|0.79|1.1||The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.||1.10|0.79|0.40
71737811|NCT06037408|142989459|SUPERIORITY||Mean Difference (Final Values)|-57.13|STANDARD_ERROR_OF_MEAN|2.759||0.0001|TWO_SIDED|95.0|-63.99|-50.27||Sidak's test was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom, 42.19||||-50.27|-63.99|0.0001
71737812|NCT06037408|142989460|SUPERIORITY||Mean Difference (Final Values)|25.12|STANDARD_ERROR_OF_MEAN|4.459|<|0.0001|TWO_SIDED|95.0|13.26|36.99|||ANOVA|Degrees of freedom, 28.16.||||36.99|13.26|<0.0001
71737813|NCT00659230|142989516|SUPERIORITY_OR_OTHER||Effect Size|-0.18||||0.723|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|The analysis was conducted using a repeated-measures analysis of variance (ANOVA) model. The model consisted of two factors - treatment at two levels and time (5 time points including baseline) and group by time interaction.||0.27|-0.64|0.723
71774562|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months||||0.500
71774563|NCT01325623|143049223|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months||||0.500
71833302|NCT00041938|143171128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.23||Secondary null hypothesis was tested at two-tailed alpha = 0.05.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.||1.23|0.93|0.33
71774564|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1529|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.1529
71833303|NCT00041938|143171129|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.005|TWO_SIDED|95.0|0.33|0.82|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.||0.82|0.33|0.005
71890025|NCT03417440|143301880|OTHER||Spearman Correlation|-0.10435||||0.3116|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Self-efficacy for Physical Activity change and Daily Steps change across 4 months.||||0.3116
71890026|NCT03417440|143301880|OTHER||Spearman Correlation|0.17742||||0.0838|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Correlation between Self-regulation of Physical Activity change and Daily Steps change across 4 months.||||0.0838
71774565|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.0942|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0942
71774566|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.2831|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2831
71890027|NCT03417440|143301880|OTHER||Spearman Correlation|-0.09834||||0.351|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Family Social Support for Physical Activity change and Daily Steps change across 4 months.||||0.3510
71890028|NCT03417440|143301880|OTHER||Spearman Correlation|-0.04562||||0.6659|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Outcome Expectation for Physical Activity change and Daily Steps change across 4 months.||||0.6659
71737814|NCT00659230|142989517|SUPERIORITY||Effect Size|-0.07||||0.54|TWO_SIDED|90.0|-0.52|0.39|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.39|-.52|0.540
71737815|NCT00659230|142989518|SUPERIORITY||Effect size|-0.18||||0.951|TWO_SIDED|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.27|-0.64|0.951
71737816|NCT00659230|142989519|SUPERIORITY||Effect Size|0.11||||0.396|TWO_SIDED|90.0|-0.35|0.56|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|||0.56|-0.35|0.396
71737817|NCT00118430|142989520|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||<0.001
71737818|NCT00118430|142989521|SUPERIORITY_OR_OTHER||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis|||||||< 0.001
71737819|NCT00118430|142989522|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71737820|NCT00118430|142989523|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Poisson|||||||<0.001
71774567|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.3639|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.3639
71774568|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.447|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.4470
71774569|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1311|TWO_SIDED||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1311
71774570|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.3898|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.3898
71774571|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0511
71774572|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0019
71774573|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1106|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.1106
71774574|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1273|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1273
71774575|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1305|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.1305
71774576|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.1123
71774577|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.2309|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.2309
71774578|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.3191|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3191
71774579|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.0679|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0679
71774580|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.2082|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.2082
71774581|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.1790
71774582|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.6869|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.6869
71774583|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.6094|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.6094
71890029|NCT03417440|143301880|OTHER||Spearman Correlation|-0.04831||||0.6402|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Aging Self-perceptions (Attitude Toward Own Aging) change and Daily Steps change across 4 months.||||0.6402
71890303|NCT03952559|143302134|SUPERIORITY||LS Mean difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.632||0.3096|TWO_SIDED|95.0|-1.88|0.6|||Mixed Models Analysis|||||0.60|-1.88|0.3096
71660554|NCT00593736|142835155|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.130
71660555|NCT00593736|142835156|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.063
71660556|NCT00593736|142835156|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
71774584|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.1530
71774585|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.3339|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.3339
71774586|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.1473|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.1473
71774587|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.5035|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5035
71774588|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.6653|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.6653
71774589|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.8622
71774590|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.4456|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.4456
71774591|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.6876|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.6876
71774592|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.0328|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score||||0.0328
71833304|NCT00041938|143171130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.22||||0.35||95.0|0.43|11.66|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.||11.66|0.43|0.35
71660557|NCT00593736|142835156|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.521
71774593|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score||||0.0067
71774594|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.5928|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score||||0.5928
71660558|NCT00593736|142835157|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.675
71660559|NCT00593736|142835157|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
71774595|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.7179|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score||||0.7179
71774596|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.5014|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score||||0.5014
71774597|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score||||0.9640
71774598|NCT01325623|143049224|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score||||0.8537
71774599|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.2079|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total||||0.2079
71774600|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.6562|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.6562
71890030|NCT03417440|143301880|OTHER||Spearman Correlation|0.13128||||0.2048|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychosocial Loss change and Daily Steps change across 4 months.||||0.2048
71737821|NCT04412707|142989537|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.946|||||TWO_SIDED|90.0|0.849|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.849|
71737822|NCT04412707|142989538|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.952|||||TWO_SIDED|90.0|0.861|1.053|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.053|0.861|
71774601|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.9376|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.9376
71774602|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0100
71774603|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.8532|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.8532
71774604|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.4954|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.4954
71774605|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.1877|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.1877
71774606|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.4189
71774607|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.2365|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.2365
71774608|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.4138|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4138
71774609|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.8701|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.8701
71774610|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0527|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0527
71774611|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.1353|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1353
71890304|NCT03952559|143302134|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.635||0.6341|TWO_SIDED|95.0|-1.55|0.95|||Mixed Models Analysis|||||0.95|-1.55|0.6341
71890305|NCT03952559|143302135|SUPERIORITY||LS Mean difference (Final Values)|5.27|STANDARD_ERROR_OF_MEAN|4.323||0.2871|TWO_SIDED|95.0|-6.54|17.09|||Mixed Models Analysis|||||17.09|-6.54|0.2871
71890306|NCT03952559|143302135|SUPERIORITY||LS Mean difference (Final Values)|4.73|STANDARD_ERROR_OF_MEAN|3.835||0.3093|TWO_SIDED|95.0|-7.83|17.29|||Mixed Models Analysis|||||17.29|-7.83|0.3093
71890307|NCT03952559|143302135|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.788||0.2912|TWO_SIDED|95.0|-18.22|8.21|||Mixed Models Analysis|||||8.21|-18.22|0.2912
71890308|NCT03952559|143302136|SUPERIORITY|Absenteeism Change from Baseline|LS Mean difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|3.119||0.6079|TWO_SIDED|95.0|-7.74|4.54|||Mixed Models Analysis|||||4.54|-7.74|0.6079
71890309|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|3.092||0.5492|TWO_SIDED|95.0|-7.94|4.24|||Mixed Models Analysis|||Absenteeism Change from Baseline||4.24|-7.94|0.5492
71890310|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|3.281||0.1338|TWO_SIDED|95.0|-11.39|1.53|||Mixed Models Analysis|||Absenteeism Change from Baseline||1.53|-11.39|0.1338
71890311|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|3.566||0.7928|TWO_SIDED|95.0|-7.96|6.08|||Mixed Models Analysis|||Presenteeism Change from Baseline||6.08|-7.96|0.7928
71890312|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.553||0.1366|TWO_SIDED|95.0|-12.3|1.69|||Mixed Models Analysis|||Presenteeism Change from Baseline||1.69|-12.30|0.1366
71890313|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.792||0.076|TWO_SIDED|95.0|-14.21|0.71|||Mixed Models Analysis|||Presenteeism Change from Baseline||0.71|-14.21|0.0760
71890314|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|4.561||0.3602|TWO_SIDED|95.0|-13.16|4.8|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||4.80|-13.16|0.3602
71890315|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|4.516||0.1678|TWO_SIDED|95.0|-15.14|2.65|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||2.65|-15.14|0.1678
71833305|NCT00041938|143171131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.91|TWO_SIDED|95.0|0.85|1.2|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|||1.20|0.85|0.91
71737823|NCT04412707|142989539|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|Adjusted geometric mean ratio (GMR)|0.955|||||TWO_SIDED|90.0|0.863|1.058|||||CVC vs. PVC, where CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs. central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.058|0.863|
71737824|NCT04412707|142989541|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.948|||||TWO_SIDED|90.0|0.736|1.222|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.222|0.736|
71737825|NCT04412707|142989541|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|[adjusted geometric mean ratio (GMR)]|0.846|||||TWO_SIDED|90.0|0.748|0.957|||||CVC vs PVC CVC is numerator and PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|For desmethyl-melflufen: Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.957|0.748|
71737826|NCT04412707|142989542|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.126|||||Data above refer to meflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.126|0.684|
71774612|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.6927|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.6927
71774613|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.4964|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.4964
71774614|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0238|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0238
71774615|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0139
71774616|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.2822|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2822
71774617|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.1363|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.1363
71774618|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0019
71774619|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.1293|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score||||0.1293
71774620|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.5252|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.5252
71774621|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0642|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0642
71737827|NCT04412707|142989542|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.897|||||TWO_SIDED|90.0|0.819|0.982|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence and administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.982|0.819|
71737828|NCT04412707|142989543|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.877|||||TWO_SIDED|90.0|0.684|1.124|||||Data above refer to melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route (PVC or CVC) as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||1.124|0.684|
71737829|NCT04412707|142989543|EQUIVALENCE|The condition for similarity was if the 90% CI for the GMR was within the bioequivalence limits of 0.8 and 1.25.|adjusted geometric mean ratio (GMR)|0.908|||||TWO_SIDED|90.0|0.833|0.989|||||Data above refer to desethyl-melflufen. CVC vs PVC CVC is numerator, PVC is denominator. Linear Mixed Effect Model included terms for period, sequence \& administration route as fixed effects and subject nested within sequence as a random effect.|Based on a geometric mean ratio (GMR) peripheral vs central of 0.95, a 90% confidence interval (CI) for the ratio of geometric means within bioequivalence limits of 0.8 and 1.25, and 80% power, a sample size of 20 patients (10 per sequence) was required assuming a within-patient variability for period differences (in log scale) of 0.29. Approximately 25 patients were to be enrolled to achieve 20 PK- and local tolerance-evaluable patients.||0.989|0.833|
71737830|NCT02467582|142989568|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
71737831|NCT02467582|142989568|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.27|1.22|||||Unstratified|||1.22|0.27|
71737832|NCT02467582|142989568|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|90.0|0.22|1.46|||||Stratified|||1.46|0.22|
71737833|NCT02467582|142989569|SUPERIORITY|||||||0.089|||||||Log Rank|||||||0.089
71737834|NCT02467582|142989569|SUPERIORITY||Hazard Ratio (HR)|0.49|||||TWO_SIDED|90.0|0.21|1.19|||||Unstratified|||1.19|0.21|
71737835|NCT02467582|142989569|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|90.0|0.2|1.55|||||Stratified|||1.55|0.20|
71737836|NCT02467582|142989570|SUPERIORITY|||||||0.3|||||||Log Rank|||||||0.3
71737837|NCT02467582|142989570|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|90.0|0.23|2.13|||||Unstratified|||2.13|0.23|
71774622|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0025
71774623|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0024
71774624|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.4464|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.4464
71774625|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0511
71774626|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.0002
71774627|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0296|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.0296
71737838|NCT02467582|142989570|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.15|2.43|||||Stratified|||2.43|0.15|
71737839|NCT01370265|142989573|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.||||0.14
71737840|NCT01370265|142989575|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05||||0.21
71737841|NCT01370265|142989576|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.||||0.57
71737842|NCT01370265|142989576|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.||||0.13
71737843|NCT01370265|142989576|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.||||0.44
71737844|NCT01370265|142989576|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.||||0.74
71737845|NCT01370265|142989577|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.||||0.78
71737846|NCT01370265|142989577|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05||||0.42
71890031|NCT03417440|143301880|OTHER||Spearman Correlation|0.10022||||0.3445|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Physical Change change and Daily Steps change across 4 months.||||0.3445
71833306|NCT00041938|143171132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.58|1.64|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.||1.64|0.58|0.93
71833307|NCT00041938|143171133|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.053|TWO_SIDED|95.0|0.998|1.47|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.||1.47|0.998|0.053
71833308|NCT00041938|143171134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.03|TWO_SIDED|95.0|0.32|0.96|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.||0.96|0.32|0.03
71833309|NCT00041938|143171135|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.77||||0.51|TWO_SIDED|95.0|0.32|9.88|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.||9.88|0.32|0.51
71833310|NCT00041938|143171136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.83||95.0|0.81|1.3|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||||1.30|0.81|0.83
71833311|NCT00041938|143171137|SUPERIORITY_OR_OTHER||Rate ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.36|3.12|||Regression, Poisson||The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.|||3.12|1.36|<0.001
71833312|NCT00041938|143171138|SUPERIORITY_OR_OTHER||Rate ratio|1.56|||<|0.001||95.0|1.34|1.81|||Regression, Poisson||Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.|||1.81|1.34|<0.001
71890032|NCT03417440|143301880|OTHER||Spearman Correlation|-0.00866||||0.934|TWO_SIDED||||||t distribution with n-2 degrees of freed|||Correlation between Views of Aging--Psychological Growth change and Daily Steps change across 4 months.||||0.9340
71890033|NCT00670709|143301881|SUPERIORITY_OR_OTHER_LEGACY||||||<|1e-07||95.0|||||t-test, 2 sided|||||||<0.0000001
71890034|NCT00670709|143301882|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005||95.0|||||t-test, 2 sided|||HD subjects vs control subjects||||<0.005
71890035|NCT03304522|143301883|SUPERIORITY||Least Squares (LS) Mean Difference|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.876|-0.293|||Mixed-effects Model for Repeated Measure|||||-0.293|-1.876|<0.0001
71737847|NCT01370265|142989577|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05||||0.96
71737848|NCT01370265|142989577|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.||||0.13
71737849|NCT01370265|142989578|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.||||0.28
71737850|NCT01370265|142989578|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.||||0.51
71737851|NCT01370265|142989579|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.||||0.31
71737852|NCT01370265|142989579|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.||||0.08
71833313|NCT02692417|143171160|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
71833314|NCT02692417|143171160|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.225
71833315|NCT02692417|143171161|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
71833316|NCT02692417|143171161|OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.046
71833317|NCT02692417|143171162|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.||||0.109
71833318|NCT02692417|143171162|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71890036|NCT03304522|143301886|SUPERIORITY||LS Mean Difference|-1.111|||<|0.0001|TWO_SIDED|95.0|-1.911|-0.312|||Mixed-effects Model for Repeated Measure|||||-0.312|-1.911|<0.0001
71890037|NCT03304522|143301888|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-1.5|0.3|||Mixed-effects Model for Repeated Measure|||||0.3|-1.5|<0.0001
71890038|NCT00885365|143301923|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is above the non-inferiority margin set at -4.5%.|difference of least square means|-0.5||||0.64|TWO_SIDED|95.0|-2.58|1.59|||ANCOVA|||Based on previous studies, the difference between reference and placebo after 4-week treatment is assumed to be about 12% and the non-inferiority margin safely placed at 4.5%. With a between-patient SD of 13.5% and estimated difference between treatments of zero, sample size of 143 per group allows a 80% power to show the non-inferiority of Bramitob® versus TOBI®. Accounting for an expected dropout rate of 11%, a minimum of 160 participants per group is required.||1.59|-2.58|0.640
71890039|NCT00885365|143301925|SUPERIORITY_OR_OTHER||difference of least square means|-0.01||||0.634|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Analysis for Week 4||0.05|-0.08|0.634
71890040|NCT00885365|143301926|SUPERIORITY_OR_OTHER||difference of least square means|-0.55||||0.63|TWO_SIDED|95.0|-2.78|1.69|||ANCOVA|||Analysis for Week 4||1.69|-2.78|0.630
71737853|NCT01959841|142989580|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(400mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||2.41e-06|||||||Modified Farrington-Manning test|||The non-inferiority of each ASP2151 dose level versus valaciclovir was assessed stepwise using a closed testing procedure.First step analysis was performed in the ASP2151(400mg) once daily.||||0.00000241
71737854|NCT01959841|142989580|NON_INFERIORITY|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(200mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||0.0688|||||||Modified Farrington-Manning test|||The analysis was performed in the ASP2151(200 mg) once daily only when non-inferiority of the ASP2151(400 mg) 0nce daily to valaciclovir 1000 mg three times daily was assumed.||||0.0688
71737855|NCT00666224|142989590|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.55||||0.0005|TWO_SIDED|95.0|0.4|0.77||Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.|Regression, Cox|||||0.77|0.40|0.0005
71737856|NCT00666224|142989591|SUPERIORITY_OR_OTHER||Rate ratio|0.42|||<|0.0001|TWO_SIDED|95.0|0.29|0.61|||Quasi-Likelihood NB* Regression|"\*NB = Negative Binomial~Center and baseline number of enhancing lesions as covariates."||||0.61|0.29|<0.0001
71737857|NCT00666224|142989592|SUPERIORITY_OR_OTHER||Geometric means ratio|0.87||||0.0013|TWO_SIDED|95.0|0.79|0.95|||ANCOVA|Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.||||0.95|0.79|0.0013
71737858|NCT00666224|142989595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.27|0.61||Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.|Regression, Logistic|||||0.61|0.27|<0.0001
71737859|NCT00265317|142989646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.3206|TWO_SIDED|80.0|0.575|1.404||Primary analysis was based on an unstratified 1-sided log rank test with alpha=0.1|Log Rank|||Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.||1.404|0.575|0.3206
71737860|NCT00265317|142989647|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.546||||0.6251|TWO_SIDED|95.0|0.267|8.954|||Cochran-Mantel-Haenszel|||95% confidence interval (CI) calculated based on f-distribution||8.954|0.267|0.6251
71737861|NCT00265317|142989648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.3732|TWO_SIDED|95.0|0.572|1.485||1-sided unstratified log-rank test|Log Rank|||||1.485|0.572|0.3732
71737862|NCT00265317|142989650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.066||||0.6171|TWO_SIDED|95.0|0.705|1.612||p-value from 1-sided unstratified log-rank test|Log Rank|||||1.612|0.705|0.6171
71737863|NCT00265317|142989651|SUPERIORITY_OR_OTHER||Percentage|32.0|||||TWO_SIDED|95.0|19.7|44.3||||||Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method||44.3|19.7|
71737864|NCT00265317|142989651|SUPERIORITY_OR_OTHER||Percentage|42.0|||||TWO_SIDED|95.0|30.1|54.2||||||Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method||54.2|30.1|
71737865|NCT00265317|142989679|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.748||||0.2247|TWO_SIDED|95.0|0.351|1.591|||Log Rank|||Positive EGFR Expression||1.591|0.351|0.2247
71890041|NCT00885365|143301927|SUPERIORITY_OR_OTHER||difference of least square means|-0.02||||0.693|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|||Analysis for Week 4||0.06|-0.09|0.693
71890042|NCT00885365|143301928|SUPERIORITY_OR_OTHER||difference of least square means|0.51||||0.777|TWO_SIDED|95.0|-3.06|4.09|||ANCOVA|||Analysis for Week 4||4.09|-3.06|0.777
71737866|NCT00265317|142989679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.184||||0.6797|TWO_SIDED|95.0|0.581|2.414|||Log Rank|||Negative EGFR Expression||2.414|0.581|0.6797
71737867|NCT00265317|142989679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
71737868|NCT00265317|142989681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3223|TWO_SIDED|95.0|0.458|1.628|||Log Rank|||Positive EGFR Expression||1.628|0.458|0.3223
71737869|NCT00265317|142989681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.4608|TWO_SIDED|95.0|0.362|2.474|||Log Rank|||Negative EGFR Expression||2.474|0.362|0.4608
71737870|NCT00265317|142989681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.632||||0.1693|TWO_SIDED|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression||1.627|0.245|0.1693
71737871|NCT00265317|142989683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.5526|TWO_SIDED|95.0|0.542|2.031|||Log Rank|||No EGFR Gene Copy Number Increase||2.031|0.542|0.5526
71737872|NCT00265317|142989683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Copy Number Increase||1.344|0.380|0.1529
71737873|NCT00265317|142989685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.5839|TWO_SIDED|95.0|0.557|2.085|||Log Rank|||No EGFR Gene Amplification||2.085|0.557|0.5839
71737874|NCT00265317|142989685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.1529|TWO_SIDED|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Amplification||1.344|0.380|0.1529
71737875|NCT00265317|142989687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.6324|TWO_SIDED|95.0|0.516|2.608|||Log Rank|||Wild Type EGFR Gene Mutation||2.608|0.516|0.6324
71737876|NCT00265317|142989687|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2413|TWO_SIDED|95.0|0.464|1.424|||Log Rank|||Indeterminate EGFR Gene Mutation||1.424|0.464|0.2413
71737877|NCT00265317|142989689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481||||0.2077|TWO_SIDED|95.0|0.079|2.91|||Log Rank|||Mutated KRAS Gene Mutation||2.910|0.079|0.2077
71890043|NCT00885365|143301929|SUPERIORITY_OR_OTHER||difference of least square means|0.04||||0.505|TWO_SIDED|95.0|-0.08|0.15|||ANCOVA|||Analysis for Week 4||0.15|-0.08|0.505
71890044|NCT00885365|143301930|SUPERIORITY_OR_OTHER||difference of least square means|0.04|STANDARD_ERROR_OF_MEAN|0.18||0.82|TWO_SIDED|95.0|-0.31|0.39||A priori threshold for statistical significance is \<= 0.050.|ANCOVA|treatment and country are fixed effects and baseline log10 bacterial load (CFU/g) value is a covariate||Analysis of Week 4 data||0.39|-0.31|0.820
71833319|NCT00780234|143171197|OTHER||Regression model parameter (α1)|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.53|TWO_SIDED|95.0|-1.68|0.89|||Regression, Linear|The estimates of treatment effect were adjusted for baseline histology values.||"The hypotheses tested were:~H0: α1 = 0 vs H1: α1 \~= 0"|The hypothesis test was a 2-sided t-test of the effect of group (i.e. the difference between the pioglitazone and placebo groups). The general form of the model is Y = α0 + α1GROUP + α2BASELINE. Y represents the 6-month value of the dependent variable (summary of the histology), GROUP represents a classification variable for the treatment group (1=pioglitazone, 2=placebo), BASELINE represents the value of the outcome measure at baseline, and α0, α1 and α2 represent the parameter estimates from the general linear model. The test of the difference between groups will be the formal test of significance of the α1 parameter.|0.89|-1.68|0.53
71833320|NCT00957242|143171198|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.32||||0.27|TWO_SIDED|95.0|0.7|2.47|||Regression, Cox|Prespecified covariates in the model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.|Warfarin vs. Placebo|The study was designed to have 90% power to detect a difference in 48-week event free rates of 70% for the warfarin group versus 50% for the placebo group. A total of at least 95 adjudicated primary endpoints were required to achieve 90% power with 2-sided, type I error rate of 0.05 and a 1:1 randomization ratio. These calculations yielded a requisite total sample size of 256.||2.47|0.70|0.27
71737878|NCT00265317|142989689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.6439|TWO_SIDED|95.0|0.534|2.531|||Log Rank|||Wild Type KRAS Gene Mutation||2.531|0.534|0.6439
71833321|NCT00957242|143171199|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|5.03||||0.005|TWO_SIDED|95.0|1.44|17.54|||Cox Proportional|||||17.54|1.44|0.005
71833322|NCT00957242|143171200|SUPERIORITY_OR_OTHER||t-value|0.08||||0.083||95.0|-0.01|0.17|||Mixed Models Analysis|||||0.17|-0.01|0.083
71833323|NCT00957242|143171201|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.054|TWO_SIDED|95.0|0.99|4.31|||Cox Proportional|||||4.31|0.99|0.054
71833324|NCT00957242|143171202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.47||||0.19|TWO_SIDED|95.0|0.64|9.56|||Cox Proportional|||||9.56|0.64|0.19
71833325|NCT00957242|143171203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.25||||0.35|TWO_SIDED|95.0|0.41|12.34|||Cox Proportional|||||12.34|0.41|0.35
71833326|NCT00957242|143171204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.24||||0.15|TWO_SIDED|95.0|0.65|16.1|||Cox Proportional|||||16.10|0.65|0.15
71833327|NCT00957242|143171205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.88|TWO_SIDED|95.0|0.24|3.39|||Cox Proportional|||||3.39|0.24|0.88
71833328|NCT00957242|143171206|SUPERIORITY_OR_OTHER||t-value|10.88||||0.7222|TWO_SIDED|95.0|-49.57|71.34|||Mixed Models Analysis|||||71.34|-49.57|0.7222
71833329|NCT00957242|143171207|SUPERIORITY_OR_OTHER||t-value|-1.78||||0.27|TWO_SIDED|95.0|-7.04|3048.0|||Mixed Models Analysis|||||3048|-7.04|0.27
71833330|NCT00957242|143171208|SUPERIORITY_OR_OTHER||t-value|0.05||||0.957|TWO_SIDED|95.0|-1.67|1076.0|||Mixed Models Analysis|||||1076|-1.67|0.957
71833331|NCT00957242|143171209|SUPERIORITY_OR_OTHER||t-value|-0.48||||0.009|TWO_SIDED|95.0|-0.84|-0.12|||Mixed Models Analysis|||||-0.12|-0.84|0.009
71737879|NCT00265317|142989689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.2664|TWO_SIDED|95.0|0.457|1.489|||Log Rank|||Indeterminate KRAS Gene Mutation||1.489|0.457|0.2664
71833332|NCT03010631|143171212|SUPERIORITY||Ratio of Geometric LS Means|1.441|||||TWO_SIDED|90.0|1.166|1.782||||||||1.782|1.166|
71833333|NCT03010631|143171213|SUPERIORITY||Ratio of Geometric LS Means|2.045|||||TWO_SIDED|90.0|1.615|2.589||||||||2.589|1.615|
71833334|NCT03010631|143171214|OTHER||Ratio of Geometric LS Means|0.888|||||TWO_SIDED|90.0|0.675|1.168||||||||1.168|0.675|
71833335|NCT03010631|143171215|OTHER||Ratio of Geometric LS Means|0.413|||||TWO_SIDED|90.0|0.339|0.502||||||||0.502|0.339|
71833336|NCT04048382|143171217|SUPERIORITY||Odds Ratio (OR)|1.1||||0.88|TWO_SIDED||||||Regression, Logistic|||||||.88
71833337|NCT04048382|143171218|SUPERIORITY||Odds Ratio (OR)|1.7||||0.49|TWO_SIDED||||||Regression, Logistic|||||||.49
71833338|NCT04048382|143171219|SUPERIORITY||Odds Ratio (OR)|1.1||||0.91|TWO_SIDED||||||Regression, Logistic|||||||.91
71833339|NCT04048382|143171220|SUPERIORITY||Odds Ratio (OR)|1.4||||0.65|TWO_SIDED||||||Regression, Logistic|||||||.65
71833340|NCT04048382|143171221|SUPERIORITY||Odds Ratio (OR)|0.29||||0.17|TWO_SIDED||||||Regression, Logistic|||||||.17
71833341|NCT04048382|143171222|SUPERIORITY||Odds Ratio (OR)|0.29||||0.19|TWO_SIDED||||||Regression, Logistic|||||||.19
71833342|NCT01255670|143171244|OTHER|Mann-Whitney U-test and Fisher's exact test||||||0.05|||||||Fisher Exact|||||||0.05
71833343|NCT01255670|143171245|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U-test and Fisher's exact test||||0.05
71833344|NCT01037985|143171246|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.168|TWO_SIDED|95.0|-10.4|1.9|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||1.9|-10.4|0.168
71833345|NCT01037985|143171247|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.858|TWO_SIDED|95.0|-3.5|4.2|||t-test, 2 sided|||Within participant treatment difference was assessed between the treatment regimens each participant received (EXC 001 minus placebo).||4.2|-3.5|0.858
71833346|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.003|TWO_SIDED|95.0|-1.6|-0.4|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.6|0.003
71833347|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.067|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||0.0|-1.1|0.067
71833348|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-1.4|||<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.7|-2.1|<0.001
71833349|NCT01037985|143171248|SUPERIORITY||Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-1.4|-0.4|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.4|0.002
71833350|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.3|-0.2|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.2|-1.3|0.007
71833351|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.214|TWO_SIDED|95.0|-1.1|0.3|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.3|-1.1|0.214
71737880|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7423|TWO_SIDED|95.0|0.541|2.36||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.360|0.541|0.7423
71737881|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.598||||0.157|TWO_SIDED|95.0|0.29|1.236||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.236|0.290|0.1570
71737882|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.7954|TWO_SIDED|95.0|0.131|4.819||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||4.819|0.131|0.7954
71737883|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.833||||0.621|TWO_SIDED|95.0|0.401|1.732||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/G||1.732|0.401|0.6210
71737884|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794||||0.5268|TWO_SIDED|95.0|0.385|1.64||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/T||1.640|0.385|0.5268
71737885|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.011||||0.9753|TWO_SIDED|95.0|0.504|2.027||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/T||2.027|0.504|0.9753
71737886|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.378||||0.0141|TWO_SIDED|95.0|0.168|0.85||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||0.850|0.168|0.0141
71737887|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
71737888|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.2788|TWO_SIDED|95.0|0.422|1.288||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.288|0.422|0.2788
71774628|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.3115|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score||||0.3115
71774629|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0270
71774630|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0008
71737889|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8971|TWO_SIDED|95.0|0.352|3.286||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||3.286|0.352|0.8971
71737890|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.6559|TWO_SIDED|95.0|0.251|2.388||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||2.388|0.251|0.6559
71833352|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.003|TWO_SIDED|95.0|-1.5|-0.3|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.5|0.003
71737891|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.939||||0.8563|TWO_SIDED|95.0|0.466|1.889||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||1.889|0.466|0.8563
71774631|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0683|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score||||0.0683
71833353|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.8|-2.2|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-2.2|-7.8|<0.001
71833354|NCT01037985|143171248|SUPERIORITY||Mean Difference (Net)|0.1||||0.673|TWO_SIDED|95.0|-0.5|0.7|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||0.7|-0.5|0.673
71737892|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.382||||0.668|TWO_SIDED|95.0|0.13|1.12||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||1.120|0.130|0.668
71737893|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs35636987 Genotype: C/C||1.309|0.488|0.3681
71737894|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.752|TWO_SIDED|95.0|0.331|2.237||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||2.237|0.331|0.7520
71737895|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.551||||0.0833|TWO_SIDED|95.0|0.276|1.098||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.098|0.276|0.0833
71737896|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.4772|TWO_SIDED|95.0|0.444|5.506||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||5.506|0.444|0.4772
71774632|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.2226|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score||||0.2226
71737897|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.034||||0.9235|TWO_SIDED|95.0|0.522|2.048||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.048|0.522|0.9235
71737898|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501||||0.0845|TWO_SIDED|95.0|0.223|1.126||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.126|0.223|0.0845
71774633|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score||||0.0823
71833355|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.276|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||1.1|-0.3|0.276
71833356|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.7|0.5|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.5|-0.7|0.670
71833357|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.5|0.5|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||0.5|-0.5|1.000
71660560|NCT00593736|142835157|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.205
71660561|NCT00593736|142835158|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.643
71660562|NCT00593736|142835158|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.032
71737899|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.724||||0.5493|TWO_SIDED|95.0|0.284|10.47||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||10.47|0.284|0.5493
71737900|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.521|TWO_SIDED|95.0|0.492|3.987||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.987|0.492|0.5210
71737901|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538||||0.0854|TWO_SIDED|95.0|0.261|1.108||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.108|0.261|0.0854
71737902|NCT00265317|142989691|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.9198|TWO_SIDED|95.0|0.365|2.489||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||2.489|0.365|0.9198
71737903|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.9486|TWO_SIDED|95.0|0.473|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C||2.014|0.473|0.9486
71737904|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.961||||0.9084|TWO_SIDED|95.0|0.487|1.897||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T||1.897|0.487|0.9084
71737905|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.876||||0.2009|TWO_SIDED|95.0|0.534|15.48||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T||15.48|0.534|0.2009
71737906|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.098||||0.7863|TWO_SIDED|95.0|0.554|2.175||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305845 Genotype: G/G||2.175|0.554|0.7863
71737907|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.5267|TWO_SIDED|95.0|0.633|2.442||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR2/rs2305945 Genotype: G/T||2.442|0.633|0.5267
71737908|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.624|TWO_SIDED|95.0|0.049|6.208||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: T/T||6.208|0.049|0.6240
71737909|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.254||||0.4882|TWO_SIDED|95.0|0.66|2.384||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR/rs1870377 Genotype: T/T||2.384|0.660|0.4882
71737910|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.587||||0.1307|TWO_SIDED|95.0|0.29|1.189||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A||1.189|0.290|0.1307
71737911|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.236||||0.5596|TWO_SIDED|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A||35.90|0.139|0.5596
71774634|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.1459|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score||||0.1459
71774635|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score||||0.2610
71774636|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.9119|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||||||0.9119
71774637|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0826|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score||||0.0826
71833358|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.909|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.909
71833359|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.852|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||0.8|-0.6|0.852
71890045|NCT00885365|143301933|SUPERIORITY_OR_OTHER|||||||0.692||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 4||||0.692
71660563|NCT00593736|142835158|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.875
71660564|NCT00593736|142835159|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.286
71774638|NCT01325623|143049228|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score||||0.0036
71833360|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.6|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.6|-0.5|0.906
71833361|NCT01037985|143171248|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.768|TWO_SIDED|95.0|-2.8|3.8|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.8|-2.8|0.768
71890046|NCT00885365|143301933|SUPERIORITY_OR_OTHER|||||||0.128||||||A priori threshold for statistical significance is \<= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 8||||0.128
71737912|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.7966|TWO_SIDED|95.0|0.628|1.833||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C||1.833|0.628|0.7966
71737913|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.954||||0.9224|TWO_SIDED|95.0|0.366|2.484||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T||2.484|0.366|0.9224
71737914|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.047||||0.9317|TWO_SIDED|95.0|0.363|3.025||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C||3.025|0.363|0.9317
71737915|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.8696|TWO_SIDED|95.0|0.546|2.044||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T||2.044|0.546|0.8696
71737916|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.8694|TWO_SIDED|95.0|0.453|2.554||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T||2.554|0.453|0.8694
71737917|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs3563987 Genotype: C/C||1.652|0.654|0.8708
71737918|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.157||||0.7667|TWO_SIDED|95.0|0.442|3.026||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C||3.026|0.442|0.7667
71737919|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755||||0.3822|TWO_SIDED|95.0|0.401|1.422||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T||1.422|0.401|0.3822
71737920|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.419||||0.5089|TWO_SIDED|95.0|0.498|4.04||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T||4.040|0.498|0.5089
71737921|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.326||||0.3944|TWO_SIDED|95.0|0.691|2.544||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G||2.544|0.691|0.3944
71737922|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.3103|TWO_SIDED|95.0|0.339|1.416||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A||1.416|0.339|0.3103
71737923|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.857||||0.8942|TWO_SIDED|95.0|0.089|8.294||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A||8.294|0.089|0.8942
71737924|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.665|TWO_SIDED|95.0|0.466|3.304||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G||3.304|0.466|0.6650
71774639|NCT02476422|143049242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2||||0.211|TWO_SIDED|95.0|-1.8|8.3|||ANCOVA|||||8.3|-1.8|0.211
71774640|NCT01288027|143049255|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||one sample t-test|||Statistical significance for change from Baseline was measured using one sample t-test||||0.1860
71833362|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.773|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.5|-0.4|0.773
71737925|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779||||0.4415|TWO_SIDED|95.0|0.412|1.475||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A||1.475|0.412|0.4415
71737926|NCT00265317|142989692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.458||||0.4682|TWO_SIDED|95.0|0.523|4.06||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A||4.060|0.523|0.4682
71737927|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.289||||0.7301|TWO_SIDED|95.0|0.304|5.47||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||5.470|0.304|0.7301
71737928|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.788||||0.5013|TWO_SIDED|95.0|0.39|1.592||2-sided unstratified log-rank test|Log Rank|||PDGFRB/rs2304060 C/A||1.592|0.390|0.5013
71737929|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.368|TWO_SIDED|95.0|0.298|1.578||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: A/A||1.578|0.298|0.3680
71737930|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738||||0.3804|TWO_SIDED|95.0|0.371|1.467||2-sided, unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.467|0.371|0.3804
71737931|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.1507|TWO_SIDED|95.0|0.261|1.247||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||1.247|0.261|0.1507
71737932|NCT00265317|142989694|SUPERIORITY_OR_OTHER|||||||0.0772||||||2-sided unstratified log-rank test|Log Rank|||Locus PDGFRB/rs17656204 Genotype: T/T||||0.0772
71737933|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.2149|TWO_SIDED|95.0|0.339|1.284||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.284|0.339|0.2149
71737934|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.9491|TWO_SIDED|95.0|0.466|2.26||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/RS2304061 Genotype: G/A||2.260|0.466|0.9491
71737935|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917||||0.8114|TWO_SIDED|95.0|0.447|1.881||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.881|0.447|0.8114
71833363|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.4|-0.4|1.000
71833364|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.072|TWO_SIDED|95.0|-1.4|0.1|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.1|-1.4|0.072
71833365|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.851|TWO_SIDED|95.0|-0.7|0.6|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.6|-0.7|0.851
71833366|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.184|TWO_SIDED|95.0|-1.2|0.2|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.2|0.184
71833367|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.059|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.059
71833368|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.04|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-1.5|0.040
71890047|NCT00888238|143301944|SUPERIORITY_OR_OTHER||Least Squares Mean|1.7|||<|0.001||90.0|1.47|1.93|||ANOVA|||||1.93|1.47|<0.001
71737936|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.577||||0.1379|TWO_SIDED|95.0|0.273|1.221||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.221|0.273|0.1379
71774641|NCT00994318|143049262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.026|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||0.95|0.44|0.026
71774642|NCT00994318|143049262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.082|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~1. FCM (high ferritin target) compared with oral iron.~2. FCM (high ferritin target) compared with FCM (low ferritin target).~3. FCM (low ferritin target) compared with oral iron."||1.05|0.45|0.082
71833369|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.12|TWO_SIDED|95.0|-4.1|0.5|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.5|-4.1|0.120
71737937|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.859||||0.5341|TWO_SIDED|95.0|0.256|13.51||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.51|0.256|0.5341
71737938|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.8564|TWO_SIDED|95.0|0.431|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||2.014|0.431|0.8564
71737939|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.5766|TWO_SIDED|95.0|0.355|1.788||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||1.788|0.355|0.5766
71737940|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.2043|TWO_SIDED|95.0|0.14|1.557||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||1.557|0.140|0.2043
71737941|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.1626|TWO_SIDED|95.0|0.214|1.317||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||1.317|0.214|0.1626
71737942|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.968|TWO_SIDED|95.0|0.484|2.006||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.006|0.484|0.9680
71737943|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.3587|TWO_SIDED|95.0|0.171|1.92||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||1.920|0.171|0.3587
71737944|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.742||||0.4635|TWO_SIDED|95.0|0.331|1.662||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||1.662|0.331|0.4635
71833370|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.094|TWO_SIDED|95.0|-4.0|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-4.0|0.094
71833371|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.243|TWO_SIDED|95.0|-0.2|0.6|||t-test, 1 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.243
71737945|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.9834|TWO_SIDED|95.0|0.476|2.069||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.069|0.476|0.9834
71737946|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||1.725|0.072|0.1764
71737947|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.2018|TWO_SIDED|95.0|0.422|1.209||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||1.209|0.422|0.2018
71737948|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.4592|TWO_SIDED|95.0|0.354|9.673||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||9.673|0.354|0.4592
71737949|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665||||0.1593|TWO_SIDED|95.0|0.373|1.184||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.184|0.373|0.1593
71737950|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.327||||0.5897|TWO_SIDED|95.0|0.469|3.755||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||3.755|0.469|0.5897
71737951|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.3681|TWO_SIDED|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.309|0.488|0.3681
71833372|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.339|TWO_SIDED|95.0|-0.2|0.6|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.6|-0.2|0.339
71833373|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.25|TWO_SIDED|95.0|-0.3|1.2|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||1.2|-0.3|0.250
71833374|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.164|TWO_SIDED|95.0|-1.3|0.2|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-1.3|0.164
71833375|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.8|0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||0.8|-0.8|1.000
71833376|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.928
71833377|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.865|TWO_SIDED|95.0|-0.8|0.7|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||0.7|-0.8|0.865
71833378|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.804|TWO_SIDED|95.0|-2.3|3.0|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||3.0|-2.3|0.804
71890048|NCT00888238|143301945|SUPERIORITY_OR_OTHER||Least Squares Mean|1.3|||<|0.001||90.0|1.08|1.52|||ANOVA|||||1.52|1.08|<0.001
71660565|NCT00593736|142835159|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.318
71660566|NCT00593736|142835159|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.483
71660567|NCT00593736|142835160|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.040
71660568|NCT00593736|142835160|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.610
71660569|NCT00593736|142835160|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.368
71660570|NCT00593736|142835161|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.352
71660571|NCT00593736|142835161|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
71660572|NCT00593736|142835161|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.297
71660573|NCT00593736|142835162|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.053
71660574|NCT00593736|142835162|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
71660575|NCT00593736|142835162|SUPERIORITY_OR_OTHER|||||||0.783||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.783
71833379|NCT01037985|143171249|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.937|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||2.4|-2.6|0.937
71833380|NCT02269475|143171256|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|100.0|||||TWO_SIDED|95.0|-1875.3|100.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||100.0|-1875.3|
71890049|NCT01748799|143301948|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||<0.01
71890050|NCT01748799|143301948|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The level for statistical significance was p\< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p\< 0.05.||||0.01
71890051|NCT03371355|143301949|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0343|TWO_SIDED|95.0|-41.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-41|0.0343
71660576|NCT00593736|142835163|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.566
71660577|NCT00593736|142835163|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.543
71833381|NCT02269475|143171257|SUPERIORITY_OR_OTHER||Vaccine efficacy (%)|27.5|||||TWO_SIDED|95.0|7.4|43.0||"No statistical tests were used, instead the confidence interval was used for showing superiority.~If lower bound of the 95% CI is greater than 0%, the efficacy of MEDI3250 is demonstrated."|Exact conditional method|Estimated by an exact conditional method in total number of cases which follows a Poisson assumption.|Vaccine efficacy (%) = (1-RR)\*100 where RR = Risk Reduction.|||43.0|7.4|
71890052|NCT03371355|143301949|SUPERIORITY||Mean Difference in % CFB|-44.0|||<|0.0001|TWO_SIDED|95.0|-56.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-28|-56|<0.0001
71833382|NCT02730871|143171259|SUPERIORITY||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
71737952|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.3235|TWO_SIDED|95.0|0.423|1.336||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.336|0.423|0.3235
71833383|NCT02730871|143171260|OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.342|<|0.001|TWO_SIDED|95.0|-2.8|-1.5|||ANCOVA|||||-1.5|-2.8|<0.001
71737953|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.7463|TWO_SIDED|95.0|0.303|2.355||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.355|0.303|0.7463
71737954|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.4179|TWO_SIDED|95.0|0.33|1.593||2-sided unstratified log-rank test|Log Rank|||Locus: rs740751 Genotype: C/C||1.593|0.330|0.4179
71737955|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9423|TWO_SIDED|95.0|0.462|2.05||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.050|0.462|0.9423
71737956|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.353||||0.1764|TWO_SIDED|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs7407451 Genotype: T/T||1.725|0.072|0.1764
71737957|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.549||||0.2352|TWO_SIDED|95.0|0.201|1.501||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.501|0.201|0.2352
71737958|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.986||||0.9674|TWO_SIDED|95.0|0.485|2.003||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.003|0.485|0.9674
71737959|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.629||||0.3524|TWO_SIDED|95.0|0.235|1.686||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||1.686|0.235|0.3524
71737960|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.809||||0.6652|TWO_SIDED|95.0|0.308|2.124||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||2.124|0.308|0.6652
71737961|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.839||||0.5931|TWO_SIDED|95.0|0.436|1.618||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||1.618|0.436|0.5931
71737962|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.475||||0.2625|TWO_SIDED|95.0|0.125|1.813||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.813|0.125|0.2625
71737963|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.2168|TWO_SIDED|95.0|0.4|1.239||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.239|0.400|0.2168
71737964|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.987||||0.9802|TWO_SIDED|95.0|0.353|2.759||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||2.759|0.353|0.9802
71737965|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.652||||0.1145|TWO_SIDED|95.0|0.378|1.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||1.122|0.378|0.1145
71833384|NCT02730871|143171261|OTHER||Mean Difference (Final Values)|-9.98|STANDARD_ERROR_OF_MEAN|1.572|<|0.001|TWO_SIDED|95.0|-13.1|-6.9|||ANCOVA|||||-6.9|-13.1|<0.001
71833385|NCT02730871|143171262|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.576||0.022|TWO_SIDED|95.0|-2.5|-0.2|||Repeated measures model|||Change from Baseline in IOP at 9:00||-0.2|-2.5|0.022
71833386|NCT02730871|143171262|OTHER||Mean Difference (Final Values)|-2.85|STANDARD_ERROR_OF_MEAN|0.506|<|0.001|TWO_SIDED|95.0|-3.9|-1.9|||Repeated measures model|||Change from Baseline in IOP at 11:00||-1.9|-3.9|<0.001
71833387|NCT02730871|143171263|OTHER||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|2.567||0.018|TWO_SIDED|95.0|-11.2|-1.1|||Repeated measures model|||Percentage Change from Baseline in IOP at 09:00||-1.1|-11.2|0.018
71833388|NCT02730871|143171263|OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-17.8|-8.6|||Repeated measures model|||Percentage Change from Baseline in IOP at 11:00||-8.6|-17.8|<0.001
71737966|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.7725|TWO_SIDED|95.0|0.36|3.946||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||3.946|0.360|0.7725
71833389|NCT01996605|143171270|SUPERIORITY||||||<|0.05||||||T|ANOVA|A one-way ANOVA was performed on the single primary outcome datapoint comparing the three groups.||The null hypothesis was that there would be no difference in area of hyperalgesia 105 minutes after study drug injection among the three groups.||||<0.05
71737967|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.687||||0.3286|TWO_SIDED|95.0|0.321|1.473||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||1.473|0.321|0.3286
71737968|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.948|TWO_SIDED|95.0|0.47|2.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||2.028|0.470|0.9480
71737969|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.531||||0.3844|TWO_SIDED|95.0|0.125|2.282||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||2.282|0.125|0.3844
71737970|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.662||||0.1373|TWO_SIDED|95.0|0.381|1.153||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.153|0.381|0.1373
71737971|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.114||||0.8586|TWO_SIDED|95.0|0.339|3.667||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||3.667|0.339|0.8586
71737972|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.935||||0.8478|TWO_SIDED|95.0|0.47|1.861||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||1.861|0.470|0.8478
71737973|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.634||||0.2445|TWO_SIDED|95.0|0.287|1.401||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.401|0.287|0.2445
71737974|NCT00265317|142989694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.9191|TWO_SIDED|95.0|0.072|18.59||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||18.59|0.072|0.9191
71833390|NCT02769858|143171296|OTHER|||||||0.001|||||||t-test, 2 sided|||||||.001
71833391|NCT02769858|143171297|OTHER|||||||0.019|||||||t-test, 2 sided|||||||.019
71833392|NCT02769858|143171298|OTHER|||||||0.502|||||||t-test, 2 sided|||||||.502
71833393|NCT02807779|143171299|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||"Power calculations were performed based on an expected reproducibility variance of 8% and an effect size of 7% was assumed based on data from pilot studies. It was estimated that 22 subjects/treatment assignment were needed to detect a 7% difference in PWV at a power level of 80%. Assigning a 20% attrition rate due to loss to follow up or index lesion revascularization, the goal enrollment was 27 subjects per arm.~No subjects in the plain balloon angioplasty group had MRI data for analysis."||||0.22
71737975|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.121||||0.8563|TWO_SIDED|95.0|0.326|3.847||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C||3.847|0.326|0.8563
71737976|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.7375|TWO_SIDED|95.0|0.599|2.064||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/A||2.064|0.599|0.7375
71737977|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.8066|TWO_SIDED|95.0|0.375|2.147||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs234060 Genotype: A/A||2.147|0.375|0.8066
71737978|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.6945|TWO_SIDED|95.0|0.449|1.708||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C||1.708|0.449|0.6945
71737979|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.8536|TWO_SIDED|95.0|0.536|2.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T||2.122|0.536|0.8536
71737980|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.732||||0.3657|TWO_SIDED|95.0|0.283|26.42||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: T/T||26.42|0.283|0.3657
71737981|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.4657|TWO_SIDED|95.0|0.424|1.483||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G||1.483|0.424|0.4657
71737982|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.364||||0.4168|TWO_SIDED|95.0|0.641|2.9||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/A||2.900|0.641|0.4168
71833394|NCT02807779|143171300|SUPERIORITY|||||||0.64||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||0.64
71833395|NCT02807779|143171301|SUPERIORITY|||||||0.95||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete MCP-1 data for analysis.||||0.95
71833396|NCT02807779|143171302|SUPERIORITY|||||||0.88||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had complete CRP data for analysis.||||0.88
71833397|NCT02807779|143171304|SUPERIORITY|||||||0.055||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.055
71833398|NCT02807779|143171305|SUPERIORITY|||||||0.22||||||Threshold for statistical significance was p=0.05.|t-test, 2 sided|||No subjects in the plain balloon angioplasty group had MRI data for analysis.||||.22
71833399|NCT02807779|143171306|SUPERIORITY|||||||0.81||||||Threshold for statistical significance was p=0.05.|Fisher Exact|||||||0.81
71833400|NCT01853748|143171322|SUPERIORITY|||||||0.0012|||||||Mantel Haenszel|||||||0.0012
71833401|NCT01853748|143171327|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
71833402|NCT01853748|143171330|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71833403|NCT04524390|143171466|SUPERIORITY||Least-Square mean|-0.39|STANDARD_ERROR_OF_MEAN|1.182||0.7419|TWO_SIDED|95.0|-2.76|1.97|||MMRM|||||1.97|-2.76|0.7419
71737983|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.908||||0.7836|TWO_SIDED|95.0|0.456|1.809||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A||1.809|0.456|0.7836
71737984|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.938||||0.8531|TWO_SIDED|95.0|0.472|1.863||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T||1.863|0.472|0.8531
71737985|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.32||||0.3272|TWO_SIDED|95.0|0.412|13.07||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T||13.07|0.412|0.3272
71737986|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.963|TWO_SIDED|95.0|0.491|1.972||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A||1.972|0.491|0.9630
71737987|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.227||||0.6003|TWO_SIDED|95.0|0.567|2.656||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G||2.656|0.567|0.6003
71737988|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.6703|TWO_SIDED|95.0|0.229|2.58||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G||2.580|0.229|0.6703
71737989|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.106||||0.81|TWO_SIDED|95.0|0.485|2.525||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G||2.525|0.485|0.8100
71833404|NCT04524390|143171467|SUPERIORITY||Least-Square mean|-45.9|STANDARD_ERROR_OF_MEAN|35.398||0.2002|TWO_SIDED|95.0|-116.86|25.05|||MMRM|||||25.05|-116.86|0.2002
71833405|NCT04524390|143171468|SUPERIORITY|||||||0.8412|||||||Barnard's exact test|||||||0.8412
71737990|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.076||||0.8335|TWO_SIDED|95.0|0.541|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C||2.141|0.541|0.8335
71737991|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.598|TWO_SIDED|95.0|0.268|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C||2.141|0.268|0.5980
71737992|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.9287|TWO_SIDED|95.0|0.487|2.199||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G||2.199|0.487|0.9287
71737993|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.053||||0.8842|TWO_SIDED|95.0|0.526|2.106||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A||2.106|0.526|0.8842
71737994|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A||4.028|0.316|0.8501
71737995|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.229||||0.4118|TWO_SIDED|95.0|0.749|2.017||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G||2.017|0.749|0.4118
71737996|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.286||||0.1299|TWO_SIDED|95.0|0.051|1.596||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A||1.596|0.051|0.1299
71737997|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.1859|TWO_SIDED|95.0|0.399|1.2||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T||1.200|0.399|0.1859
71737998|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.672||||0.0091|TWO_SIDED|95.0|1.291|10.44||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C||10.44|1.291|0.0091
71737999|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8708|TWO_SIDED|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C||1.652|0.654|0.8708
71738000|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9888|TWO_SIDED|95.0|0.59|1.681||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T||1.681|0.590|0.9888
71738001|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9702|TWO_SIDED|95.0|0.36|2.891||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G||2.891|0.360|0.9702
71738002|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973||||0.9419|TWO_SIDED|95.0|0.466|2.032||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/C||2.032|0.466|0.9419
71738003|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.7677|TWO_SIDED|95.0|0.549|2.252||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T||2.252|0.549|0.7677
71738004|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.129||||0.8501|TWO_SIDED|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: T/T||4.028|0.316|0.8501
71738005|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5233|TWO_SIDED|95.0|0.322|1.782||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G||1.782|0.322|0.5233
71738006|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.123||||0.75|TWO_SIDED|95.0|0.549|2.297||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A||2.297|0.549|0.7500
71738007|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.6614|TWO_SIDED|95.0|0.483|3.142||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A||3.142|0.483|0.6614
71738008|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.779||||0.2552|TWO_SIDED|95.0|0.652|4.855||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T||4.855|0.652|0.2552
71738009|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.088||||0.7931|TWO_SIDED|95.0|0.577|2.052||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G||2.052|0.577|0.7931
71738010|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.449||||0.1365|TWO_SIDED|95.0|0.152|1.331||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G||1.331|0.152|0.1365
71738011|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.5544|TWO_SIDED|95.0|0.504|1.447||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G||1.447|0.504|0.5544
71738012|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.721||||0.3132|TWO_SIDED|95.0|0.59|5.021||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A||5.021|0.590|0.3132
71774643|NCT00994318|143049262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.39|0.93|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.93|0.39|0.020
71738013|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.263||||0.3698|TWO_SIDED|95.0|0.755|2.113||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T||2.113|0.755|0.3698
71738014|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.411||||0.1495|TWO_SIDED|95.0|0.119|1.423||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A||1.423|0.119|0.1495
71738015|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.1911|TWO_SIDED|95.0|0.781|3.332||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A||3.332|0.781|0.1911
71738016|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.5259|TWO_SIDED|95.0|0.384|1.636||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G||1.636|0.384|0.5259
71738017|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.331||||0.0996|TWO_SIDED|95.0|0.082|1.339||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G||1.339|0.082|0.0996
71738018|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.752||||0.2755|TWO_SIDED|95.0|0.45|1.259||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G||1.259|0.450|0.2755
71738019|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.85||||0.012|TWO_SIDED|95.0|1.253|18.78||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A||18.78|1.253|0.0120
71738020|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.274||||0.4663|TWO_SIDED|95.0|0.661|2.457||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G||2.457|0.661|0.4663
71738021|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.867||||0.7097|TWO_SIDED|95.0|0.406|1.848||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A||1.848|0.406|0.7097
71738022|NCT00265317|142989695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.607||||0.534|TWO_SIDED|95.0|0.117|3.158||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A||3.158|0.117|0.5340
71738023|NCT00265317|142989698|SUPERIORITY_OR_OTHER|||||||0.2702|||||||Wilcoxon Rank Sum Test|||VEGF-C Ratio to Baseline for Cycle 2, Day 1||||0.2702
71738024|NCT00265317|142989698|SUPERIORITY_OR_OTHER|||||||0.7354||95.0|||||Wilcoxon Rank Sum Test|||VEGF-C ratio to Baseline for Cycle 3, Day 1||||0.7354
71738025|NCT00265317|142989700|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
71738026|NCT00265317|142989700|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
71660578|NCT00593736|142835163|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.847
71660579|NCT00593736|142835164|SUPERIORITY_OR_OTHER|||||||0.356||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.356
71660580|NCT00593736|142835164|SUPERIORITY_OR_OTHER|||||||0.964||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.964
71660581|NCT00593736|142835164|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.799
71660582|NCT00593736|142835165|SUPERIORITY_OR_OTHER|||||||0.698||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.698
71660583|NCT00593736|142835165|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.385
71660584|NCT00593736|142835165|SUPERIORITY_OR_OTHER|||||||0.641||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.641
71660585|NCT00593736|142835166|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.979
71660586|NCT00593736|142835166|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.194
71660587|NCT00593736|142835166|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
71738027|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.553||||0.1667|TWO_SIDED|95.0|0.159|1.921||1-sided unstratified log-rank test|Log Rank|||High CSF-1R expression||1.921|0.159|0.1667
71660588|NCT00593736|142835167|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.975
71660589|NCT00593736|142835167|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.639
71660590|NCT00593736|142835167|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.109
71660591|NCT00593736|142835168|SUPERIORITY_OR_OTHER|||||||0.823||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.823
71738028|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.451||||0.7688|TWO_SIDED|95.0|0.534|3.944||1-sided unstratified log-rank test|Log Rank|||Low CSF-1R expression||3.944|0.534|0.7688
71738029|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3498|TWO_SIDED|95.0|0.503|1.574||1-sided unstratified log-rank test|Log Rank|||Indeterminate CSF-1R expression||1.574|0.503|0.3498
71738030|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.687||||0.9497|TWO_SIDED|95.0|0.79|9.143||1-sided unstratified log-rank test|Log Rank|||High PDGFRalpha expression||9.143|0.790|0.9497
71738031|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.386||||0.0401|TWO_SIDED|95.0|0.127|1.173||1-sided unstratified log-rank test|Log Rank|||Low PDGFRalpha expression||1.173|0.127|0.0401
71738032|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.862||||0.3128|TWO_SIDED|95.0|0.487|1.524||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRalpha expression||1.524|0.487|0.3128
71738033|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.823||||0.365|TWO_SIDED|95.0|0.273|2.488||1-sided unstratified log-rank test|Log Rank|||High PDGFRbeta expression||2.488|0.273|0.3650
71738034|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.192||||0.6105|TWO_SIDED|95.0|0.408|3.48||1-sided unstratified log-rank test|Log Rank|||Low PDGFRbeta expression||3.480|0.408|0.6105
71738035|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.3027|TWO_SIDED|95.0|0.488|1.502||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRbeta expression||1.502|0.488|0.3027
71738036|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.914||||0.4436|TWO_SIDED|95.0|0.262|3.184||1-sided unstratified log-rank test|Log Rank|||High VEGF expression||3.184|0.262|0.4436
71738037|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.4582|TWO_SIDED|95.0|0.296|3.062||1-sided unstratified log-rank test|Log Rank|||Low VEGF expression||3.062|0.296|0.4582
71774644|NCT00994318|143049262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.008|TWO_SIDED|95.0|0.43|0.88|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."||0.88|0.43|0.008
71774645|NCT00994318|143049262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.1|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)"||1.10|0.45|0.12
71774646|NCT02694523|143049271|OTHER||difference in percentage of participants|24.9|||<|0.001|TWO_SIDED|95.0|17.5|32.4|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).||32.4|17.5|<0.001
71774647|NCT02694523|143049272|OTHER||difference in percentage of participants|23.3|||<|0.001|TWO_SIDED|95.0|16.6|30.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||30.1|16.6|<0.001
71774648|NCT02694523|143049273|OTHER||difference in percentage of participants|45.0|||<|0.001|TWO_SIDED|95.0|28.9|61.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||61.1|28.9|<0.001
71774649|NCT02694523|143049274|OTHER||difference in percentage of participants|18.9|||<|0.001|TWO_SIDED|95.0|13.0|24.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||24.9|13.0|<0.001
71774650|NCT02694523|143049275|OTHER||difference in percentage of participants|16.7|||<|0.001|TWO_SIDED|95.0|9.5|23.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||23.9|9.5|<0.001
71774651|NCT02694523|143049276|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
71774652|NCT02694523|143049277|OTHER||difference in percentage of participants|32.8|||<|0.001|TWO_SIDED|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||46.9|18.8|<0.001
71774653|NCT02694523|143049278|OTHER||difference in percentage of participants|38.9|||<|0.001|TWO_SIDED|95.0|22.0|55.8|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||55.8|22.0|<0.001
71774654|NCT05896748|143049295|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.901|0.998|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.998|0.901|
71774655|NCT05896748|143049295|OTHER||Ratio of geometric least square mean|0.935|||||TWO_SIDED|90.0|0.877|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||0.995|0.877|
71833406|NCT04524390|143171469|SUPERIORITY||||||>|0.9999|||||||Barnard's exact test|||||||> 0.9999
71833407|NCT04524390|143171470|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
71774656|NCT05896748|143049295|OTHER||Ratio of geometric least square mean|0.934|||||TWO_SIDED|90.0|0.872|1.0|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB||1.000|0.872|
71774657|NCT05896748|143049295|OTHER||Ratio of geometric least square mean|0.999|||||TWO_SIDED|90.0|0.943|1.059|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within CAB||1.059|0.943|
71774658|NCT05896748|143049296|OTHER||Ratio of geometric least square mean|1.002|||||TWO_SIDED|90.0|0.952|1.056|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.056|0.952|
71774659|NCT05896748|143049296|OTHER||Ratio of geometric least square mean|0.961|||||TWO_SIDED|90.0|0.921|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||1.002|0.921|
71774660|NCT05896748|143049296|OTHER||Ratio of geometric least square mean|0.928|||||TWO_SIDED|90.0|0.885|0.973|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV||0.973|0.885|
71774661|NCT05896748|143049296|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.955|1.053|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Ctau within RPV||1.053|0.955|
71774662|NCT05896748|143049297|OTHER||Ratio of geometric least square mean|0.942|||||TWO_SIDED|90.0|0.897|0.99|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.990|0.897|
71774663|NCT05896748|143049297|OTHER||Ratio of geometric least square mean|0.911|||||TWO_SIDED|90.0|0.86|0.965|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.965|0.860|
71833408|NCT04524390|143171471|SUPERIORITY|||||||0.6236|||||||Barnard's exact test|||||||0.6236
71833409|NCT04524390|143171472|SUPERIORITY|||||||0.6658|||||||Barnard's exact test|||||||0.6658
71833410|NCT04524390|143171473|SUPERIORITY|||||||0.6659|||||||Barnard's exact test|||||||0.6659
71833411|NCT02217904|143171478|SUPERIORITY||Posterior mean difference|-1.64|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
71660592|NCT00593736|142835168|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.004
71660593|NCT00593736|142835168|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.296
71738038|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.911||||0.372|TWO_SIDED|95.0|0.536|1.548||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF expression||1.548|0.536|0.3720
71738039|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5586|TWO_SIDED|95.0|0.35|3.397||1-sided unstratified log-rank test|Log Rank|||High VEGF-C expression||3.397|0.350|0.5586
71738040|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.842||||0.3652|TWO_SIDED|95.0|0.313|2.266||1-sided unstratified log-rank test|Log Rank|||Low VEGF-C expression||2.266|0.313|0.3652
71738041|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.875||||0.3301|TWO_SIDED|95.0|0.493|1.554||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF-C expression||1.554|0.493|0.3301
71738042|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.097||||0.5605|TWO_SIDED|95.0|0.331|3.636||1-sided unstratified log-rank test|Log Rank|||High VEGFR1 expression||3.636|0.331|0.5605
71738043|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.599||||0.2132|TWO_SIDED|95.0|0.16|2.236||1-sided unstratified log-rank test|Log Rank|||Low VEGFR1 expression||2.236|0.160|0.2132
71774664|NCT05896748|143049297|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.857|0.966|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB||0.966|0.857|
71774665|NCT05896748|143049297|OTHER||Ratio of geometric least square mean|1.003|||||TWO_SIDED|90.0|0.938|1.074|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within CAB||1.074|0.938|
71774666|NCT05896748|143049298|OTHER||Ratio of geometric least square mean|0.938|||||TWO_SIDED|90.0|0.895|0.982|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.982|0.895|
71660594|NCT00593736|142835169|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.092
71660595|NCT00593736|142835169|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.025
71660596|NCT00593736|142835169|SUPERIORITY_OR_OTHER|||||||0.732||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.732
71660597|NCT00593736|142835170|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.298
71738044|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.902||||0.3605|TWO_SIDED|95.0|0.53|1.537||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR1 expression||1.537|0.530|0.3605
71738045|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921||||0.4438|TWO_SIDED|95.0|0.304|2.784||1-sided unstratified log-rank test|Log Rank|||High VEGFR2 expression||2.784|0.304|0.4438
71738046|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.122||||0.5699|TWO_SIDED|95.0|0.403|3.125||1-sided unstratified log-rank test|Log Rank|||Low VEGFR2 expression||3.125|0.403|0.5699
71738047|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.3147|TWO_SIDED|95.0|0.489|1.528||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR2 expression||1.528|0.489|0.3147
71738048|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002||||0.5015|TWO_SIDED|95.0|0.281|3.581||1-sided unstratified log-rank test|Log Rank|||High VEGFR3 expression||3.581|0.281|0.5015
71738049|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.005||||0.4887|TWO_SIDED|95.0|0.334|3.025||1-sided unstratified log-rank test|Log Rank|||Low VEGFR3 expression||3.025|0.334|0.4887
71738050|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.818||||0.2432|TWO_SIDED|95.0|0.473|1.414||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR3 expression||1.414|0.473|0.2432
71738051|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446||||0.2321|TWO_SIDED|95.0|0.048|4.101||1-sided unstratified log-rank test|Log Rank|||Detected FGF expression||4.101|0.048|0.2321
71738052|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.316||||0.7143|TWO_SIDED|95.0|0.526|3.292||1-sided unstratified log-rank test|Log Rank|||No detected FGF expression||3.292|0.526|0.7143
71738053|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.844||||0.2812|TWO_SIDED|95.0|0.486|1.465||1-sided unstratified log-rank test|Log Rank|||Indeterminate FGF expression||1.465|0.486|0.2812
71738054|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.406||||0.6504|TWO_SIDED|95.0|0.248|7.96||1-sided unstratified log-rank test|Log Rank|||Detected FLT3 expression||7.960|0.248|0.6504
71738055|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838||||0.3266|TWO_SIDED|95.0|0.375|1.876||1-sided unstratified log-rank test|Log Rank|||No detected FLT3 expression||1.876|0.375|0.3266
71738056|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate FLT3 expression||1.598|0.502|0.3597
71774667|NCT05896748|143049298|OTHER||Ratio of geometric least square mean|0.918|||||TWO_SIDED|90.0|0.876|0.963|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.963|0.876|
71774668|NCT05896748|143049298|OTHER||Ratio of geometric least square mean|0.905|||||TWO_SIDED|90.0|0.861|0.952|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV||0.952|0.861|
71774669|NCT05896748|143049298|OTHER||Ratio of geometric least square mean|0.937|||||TWO_SIDED|90.0|0.891|0.986|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for Cmax within RPV||0.986|0.891|
71774670|NCT05896748|143049299|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.906|0.983|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.983|0.906|
71774671|NCT05896748|143049299|OTHER||Ratio of geometric least square mean|0.944|||||TWO_SIDED|90.0|0.895|0.995|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.995|0.895|
71774672|NCT05896748|143049299|OTHER||Ratio of geometric least square mean|0.933|||||TWO_SIDED|90.0|0.876|0.994|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB||0.994|0.876|
71774673|NCT05896748|143049299|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.979|1.105|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within CAB||1.105|0.979|
71774674|NCT05896748|143049300|OTHER||Ratio of geometric least square mean|0.966|||||TWO_SIDED|90.0|0.932|1.002|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||1.002|0.932|
71833412|NCT02217904|143171478|SUPERIORITY||Posterior mean difference|-1.32|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
71833413|NCT02217904|143171478|SUPERIORITY||Posterior mean difference|-1.57|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
71774675|NCT05896748|143049300|OTHER||Ratio of geometric least square mean|0.955|||||TWO_SIDED|90.0|0.922|0.989|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.989|0.922|
71774676|NCT05896748|143049300|OTHER||Ratio of geometric least square mean|0.948|||||TWO_SIDED|90.0|0.907|0.991|||Mixed effect analysisofcovariance(ANCOVA|||To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV||0.991|0.907|
71774677|NCT05896748|143049300|OTHER||Ratio of geometric least square mean|1.014|||||TWO_SIDED|90.0|0.972|1.058|||Mixed effect analysisofcovariance(ANCOVA|||To compare the IM gluteal injections for AUC\[0-tau\] within RPV||1.058|0.972|
71890053|NCT03371355|143301949|SUPERIORITY||Mean Difference in % CFB|-37.0||||0.0009|TWO_SIDED|95.0|-52.0|-17.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-17|-52|0.0009
71890054|NCT03371355|143301950|SUPERIORITY||Least Squares Mean Difference|-49.87|||<|0.0001|TWO_SIDED|95.0|-62.68|-37.06|||ANCOVA|||||-37.06|-62.68|<0.0001
71774678|NCT00620464|143049396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||90.0||||Applies to all parameters.|Bioequivalence Testing|||||||0.05
71774679|NCT00620464|143049397|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.05||95.0|||||Bioequivalence Testing|||||||<=0.05
71774680|NCT01209923|143049438|OTHER|||||||0.001|||||||t-test, 2 sided|Independent t-test||Children BIA was compared to hydrostatic weighing; adults were compared to DEXA.||||0.001
71774681|NCT02001181|143049439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.8|STANDARD_ERROR_OF_MEAN|8.48|<|0.0001|TWO_SIDED|80.0|-62.8|-40.8|||Mixed Models Analysis|The mixed model for repeated measures analysis included all the participants in FAS.||||-40.8|-62.8|<0.0001
71774682|NCT01842815|143049444|SUPERIORITY|||||||0.0077||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0077
71774683|NCT01842815|143049445|SUPERIORITY|||||||0.00012||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.00012
71774684|NCT01842815|143049446|SUPERIORITY|||||||0.0034||||||The value looked at for statistical significance is if p\<.05.|t-test, 2 sided|t-tailed, paired t-test||This t-test is to test the statistical significance of the right side of the tattoo clearance vs. the left side of the tattoo clearance. It tests if there is a difference between the tattoo being treated twice per visit (right side) vs. being treated once per visit (left side).||||.0034
71774685|NCT00252629|143049467|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||t-test, 2 sided|||The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0002
71774686|NCT00252629|143049468|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||t-test, 2 sided|||The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.0008
71774687|NCT00252629|143049469|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.||||0.004
71738057|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.342||||0.6907|TWO_SIDED|95.0|0.419|4.297||1-sided unstratified log-rank test|Log Rank|||Detected KIT expression||4.297|0.419|0.6907
71738058|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.199|TWO_SIDED|95.0|0.265|1.731||1-sided unstratified log-rank test|Log Rank|||Participants with no detected KIT expression||1.731|0.265|0.1990
71738059|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.896||||0.3597|TWO_SIDED|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate KIT expression||1.598|0.502|0.3597
71738060|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.693||||0.3757|TWO_SIDED|95.0|0.071|6.765||1-sided unstratified log-rank test|Log Rank|||Detected RET expression||6.765|0.071|0.3757
71738061|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3723|TWO_SIDED|95.0|0.358|2.13||1-sided unstratified log-rank test|Log Rank|||No detected RET expression||2.130|0.358|0.3723
71738062|NCT00265317|142989701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.3263|TWO_SIDED|95.0|0.501|1.523||1-sided unstratified log-rank test|Log Rank|||Indeterminate RET expression||1.523|0.501|0.3263
71738063|NCT00265317|142989702|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 2, Day 1||||<0.0001
71738064|NCT00265317|142989702|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 3, Day 1||||<0.0001
71738065|NCT00265317|142989704|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 2, Day 1||||<0.0001
71774688|NCT00252629|143049470|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|||The p value was based on t-test||||0.0001
71774689|NCT01278160|143049471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-0.24|0.22|||ANCOVA|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate.||The null hypothesis is H0: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) = 0 against the alternative hypothesis HA: μBIAsp 30 (2:1) - μBIAsp 30 (1:1) ≠ 0. This trial is an extension to BIAsp-3756 (NCT01123980), hence no particular sample size calculation was made.||0.22|-0.24|
71890055|NCT03371355|143301950|SUPERIORITY||Least Squares Mean Difference|-71.66|||<|0.0001|TWO_SIDED|95.0|-84.47|-58.85|||ANCOVA|||||-58.85|-84.47|<0.0001
71738066|NCT00265317|142989704|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 3, Day 1||||<0.0001
71738067|NCT00265317|142989709|SUPERIORITY_OR_OTHER|||||||0.3681||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3681
71738068|NCT00265317|142989710|SUPERIORITY_OR_OTHER|||||||0.5982||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.5982
71738069|NCT00265317|142989711|SUPERIORITY_OR_OTHER|||||||0.9807||95.0||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.9807
71738070|NCT00265317|142989712|SUPERIORITY_OR_OTHER|||||||0.3945||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test|||||||0.3945
71738071|NCT00711971|142989719|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Significance for the BDI test at 26-28 weeks||||.29
71738072|NCT00711971|142989719|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||Significance for BDI at 34-36 weeks gestation||||.51
71738073|NCT00711971|142989719|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||BDI score at 6-8 weeks postpartum||||.56
71738074|NCT00711971|142989720|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Gestational diabetes mellitus||||.06
71738075|NCT00711971|142989720|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||Hypertension or preeclampsia||||.12
71738076|NCT00711971|142989720|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Induced labor||||.20
71738077|NCT00711971|142989720|SUPERIORITY_OR_OTHER|||||||0.08|||||||Fisher Exact|||Cesarean section||||.08
71738078|NCT00711971|142989720|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||Spontaneous vaginal delivery||||.88
71738079|NCT00711971|142989720|SUPERIORITY_OR_OTHER|||||||0.32|||||||Fisher Exact|||Operative vaginal delivery||||.32
71738080|NCT00711971|142989721|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
71738081|NCT00711971|142989722|SUPERIORITY_OR_OTHER|||||||0.81|||||||ANOVA|||||||.81
71738082|NCT00711971|142989723|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.||||||<.001
71738083|NCT00711971|142989724|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANOVA|||||||.39
71738084|NCT00711971|142989725|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|||||||.19
71738085|NCT00711971|142989726|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71738086|NCT00711971|142989727|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||||||0.54
71738087|NCT02967510|142989728|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.304|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.304
71738088|NCT02967510|142989728|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.109|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.109
71738089|NCT02967510|142989728|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.119|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.119
71738090|NCT02967510|142989729|SUPERIORITY||LS Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.031|-0.444|||ANCOVA|||||-0.444|-1.031|<0.001
71738091|NCT02967510|142989729|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.051|-0.458|||ANCOVA|||||-0.458|-1.051|<0.001
71890056|NCT03371355|143301950|SUPERIORITY||Least Squares Mean Difference|-59.74|||<|0.0001|TWO_SIDED|95.0|-74.04|-45.44|||ANCOVA|||||-45.44|-74.04|<0.0001
71890057|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-16.5||||0.0327|TWO_SIDED|95.0|-31.59|-1.39|||ANCOVA|||TC||-1.39|-31.59|0.0327
71774690|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed models analysis|0.2||||0.2569||95.0|-0.15|0.56||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.56|-0.15|0.2569
71774691|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed models analysis|0.09||||0.812||95.0|-0.63|0.8||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.80|-0.63|0.8120
71774692|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|0.35||||0.2843||95.0|-0.29|0.99||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.99|-0.29|0.2843
71774693|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.4614||95.0|-0.5|1.11||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.11|-0.50|0.4614
71890058|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-37.0|||<|0.0001|TWO_SIDED|95.0|-52.15|-21.94|||ANCOVA|||TC||-21.94|-52.15|<0.0001
71890059|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-31.6||||0.0003|TWO_SIDED|95.0|-48.23|-15.05|||ANCOVA|||TC||-15.05|-48.23|0.0003
71738092|NCT02967510|142989729|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.951|-0.369|||ANCOVA|||||-0.369|-0.951|<0.001
71738093|NCT02967510|142989730|SUPERIORITY||LS Mean Difference|0.21|||<|0.001|TWO_SIDED|95.0|0.147|0.278|||ANCOVA|||||0.278|0.147|<0.001
71774694|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|0.44||||0.1591||95.0|-0.17|1.04||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||1.04|-0.17|0.1591
71774695|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|0.03||||0.9327||95.0|-0.63|0.69||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.69|-0.63|0.9327
71774696|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.25||||0.4063||95.0|-0.84|0.34||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is bedtime profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.34|-0.84|0.4063
71774697|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|0.3||||0.2198||95.0|-0.18|0.79||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is 2.00 - 4.00 a.m. profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.79|-0.18|0.2198
71890060|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|7.5||||0.256|TWO_SIDED|95.0|-5.55|20.54|||ANCOVA|||LDL-C||20.54|-5.55|0.2560
71890061|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-8.6||||0.1795|TWO_SIDED|95.0|-21.26|4.05|||ANCOVA|||LDL-C||4.05|-21.26|0.1795
71890062|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-8.8||||0.2065|TWO_SIDED|95.0|-22.48|4.95|||ANCOVA|||LDL-C||4.95|-22.48|0.2065
71890063|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-2.7||||0.1515|TWO_SIDED|95.0|-6.43|1.01|||ANCOVA|||HDL-C||1.01|-6.43|0.1515
71738094|NCT02967510|142989730|SUPERIORITY||LS Mean Difference|0.15|||<|0.001|TWO_SIDED|95.0|0.078|0.213|||ANCOVA|||||0.213|0.078|<0.001
71738095|NCT02967510|142989730|SUPERIORITY||LS Mean Difference|0.16|||<|0.001|TWO_SIDED|95.0|0.097|0.226|||ANCOVA|||||0.226|0.097|<0.001
71738096|NCT02967510|142989731|SUPERIORITY||LS Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.603|-0.4|||ANCOVA|||||-0.4|-0.603|<0.001
71738097|NCT02967510|142989731|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.572|-0.365|||ANCOVA|||||-0.365|-0.572|<0.001
71738098|NCT02967510|142989731|SUPERIORITY||LS Mean Difference|-0.43|||<|0.001|TWO_SIDED|95.0|-0.531|-0.331|||ANCOVA|||||-0.331|-0.531|<0.001
71738099|NCT02967510|142989732|SUPERIORITY||Mean Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.47
71738100|NCT02967510|142989732|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.448|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|0|-1|=0.448
71738101|NCT02967510|142989732|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.451|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.451
71738102|NCT02967510|142989733|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.329|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.329
71738103|NCT02967510|142989733|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.348|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.348
71738104|NCT02967510|142989733|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
71738105|NCT02967510|142989734|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.122|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.122
71738106|NCT02967510|142989734|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.188|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.188
71738107|NCT02967510|142989734|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.222|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.222
71774698|NCT01278160|143049472|SUPERIORITY_OR_OTHER||Mixed model analysis|-0.04||||0.8424||95.0|-0.47|0.38|||Mixed Models Analysis||Confidence interval is before breakfast the following day profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.||0.38|-0.47|0.8424
71890064|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.29|-4.91|||ANCOVA|||HDL-C||-4.91|-12.29|<0.0001
71890065|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-4.1||||0.0436|TWO_SIDED|95.0|-8.18|-0.12|||ANCOVA|||HDL-C||-0.12|-8.18|0.0436
71890066|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-9.1||||0.0224|TWO_SIDED|95.0|-16.94|-1.33|||ANCOVA|||VLDL-C||-1.33|-16.94|0.0224
71890067|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-15.4||||0.0001|TWO_SIDED|95.0|-22.94|-7.84|||ANCOVA|||VLDL-C||-7.84|-22.94|0.0001
71738108|NCT02967510|142989735|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.393|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.393
71738109|NCT02967510|142989735|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.221|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.221
71738110|NCT02967510|142989735|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.432|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.432
71738111|NCT02967510|142989736|SUPERIORITY||LS Mean Difference|0.24|||=|0.65|TWO_SIDED|95.0|-1.0|1.487|||ANCOVA|||||1.487|-1|=0.65
71738112|NCT02967510|142989736|SUPERIORITY||LS Mean Difference|-0.24|||=|0.361|TWO_SIDED|95.0|-1.568|1.09|||ANCOVA|||||1.09|-1.568|=0.361
71738113|NCT02967510|142989736|SUPERIORITY||LS Mean Difference|0.03|||=|0.522|TWO_SIDED|95.0|-1.188|1.257|||ANCOVA|||||1.257|-1.188|=0.522
71774699|NCT01278160|143049473|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7312||95.0|0.36|2.06|||Regression, Logistic||The odds ratio and 95% confidence interval for the HbA1c below 7% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||2.06|0.36|0.7312
71774700|NCT01278160|143049474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.1257||95.0|0.05|1.44|||Regression, Logistic|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate|The odds ratio and 95% confidence interval for the HbA1c below or equal to 6.5% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.||1.44|0.05|0.1257
71774701|NCT01278160|143049475|SUPERIORITY_OR_OTHER||Rate ratio|0.72||||0.1911||95.0|0.43|1.18|||Negative binomial regression model||For all episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.18|0.43|0.1911
71774702|NCT01278160|143049475|SUPERIORITY_OR_OTHER||Rate ratio|1.61||||0.2949||95.0|0.66|3.92|||Negative binomial regression model||For nocturnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||3.92|0.66|0.2949
71774703|NCT01278160|143049475|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077||95.0|0.38|1.05|||Negative binomial regression model||For diurnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.05|0.38|0.0770
71774704|NCT01278160|143049475|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.1687||95.0|0.25|1.27|||Negative binomial regression model||For minor episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.||1.27|0.25|0.1687
71774705|NCT01483807|143049478|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.254|ONE_SIDED||||||t-test, 1 sided|||Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.||||.254
71774706|NCT01483807|143049479|SUPERIORITY||Mean Difference (Final Values)|8.25||||0.043|ONE_SIDED||||||t-test, 1 sided|||On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.||||.043
71774707|NCT01483807|143049480|SUPERIORITY|||||||0.396|||||||t-test, 1 sided|||Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.||||.396
71738114|NCT02967510|142989737|SUPERIORITY||LS Mean Difference|-0.56|||=|0.043|TWO_SIDED|95.0|-1.204|0.079|||ANCOVA|||||0.079|-1.204|=0.043
71738115|NCT02967510|142989737|SUPERIORITY||LS Mean Difference|-0.51|||=|0.061|TWO_SIDED|95.0|-1.158|0.137|||ANCOVA|||||0.137|-1.158|=0.061
71738116|NCT02967510|142989737|SUPERIORITY||LS Mean Difference|-0.48|||=|0.071|TWO_SIDED|95.0|-1.111|0.16|||ANCOVA|||||0.16|-1.111|=0.071
71738117|NCT02967510|142989738|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.012|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.012
71774708|NCT01483807|143049481|SUPERIORITY|||||||0.212|||||||t-test, 1 sided|||Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.||||.212
71774709|NCT02819518|143049484|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.012|TWO_SIDED|95.0|0.7|0.98||One-sided p-value based on log-rank test stratified by chemotherapy (taxane versus \[vs\] gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs. no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.98|0.70|0.0120
71890068|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-10.8||||0.0091|TWO_SIDED|95.0|-18.86|-2.78|||ANCOVA|||VLDL-C||-2.78|-18.86|0.0091
71890069|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-13.9||||0.0748|TWO_SIDED|95.0|-29.12|1.42|||ANCOVA|||Non-HDL-C||1.42|-29.12|0.0748
71890070|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-28.4||||0.0004|TWO_SIDED|95.0|-43.68|-13.18|||ANCOVA|||Non-HDL-C||-13.18|-43.68|0.0004
71890071|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-27.4||||0.0016|TWO_SIDED|95.0|-44.08|-10.64|||ANCOVA|||Non-HDL-C||-10.64|-44.08|0.0016
71738118|NCT02967510|142989738|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.007|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.007
71738119|NCT02967510|142989738|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71738120|NCT02967510|142989739|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.438|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.438
71738121|NCT02967510|142989739|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.388|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.388
71738122|NCT02967510|142989739|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
71738123|NCT02967510|142989740|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
71738124|NCT02967510|142989740|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.02|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.02
71738125|NCT02967510|142989740|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.003|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.003
71738126|NCT02967510|142989741|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.002|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.002
71738127|NCT02967510|142989741|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.331|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.331
71774710|NCT02819518|143049485|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0016|TWO_SIDED|95.0|0.62|0.91||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.91|0.62|0.0016
71774711|NCT02819518|143049486|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0018|TWO_SIDED|95.0|0.5|0.88||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.88|0.50|0.0018
71890072|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-2.44||||0.6005|TWO_SIDED|95.0|-11.68|6.8|||ANCOVA|||ApoB||6.80|-11.68|0.6005
71890073|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-9.83||||0.0374|TWO_SIDED|95.0|-19.07|-0.59|||ANCOVA|||ApoB||-0.59|-19.07|0.0374
71890074|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-5.28||||0.31|TWO_SIDED|95.0|-15.55|5.0|||ANCOVA|||ApoB||5.00|-15.55|0.3100
71890075|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-1.002||||0.0728|TWO_SIDED|95.0|-2.1|0.09|||ANCOVA|||ApoB-48||0.09|-2.10|0.0728
71890076|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-1.803||||0.0018|TWO_SIDED|95.0|-2.91|-0.69|||ANCOVA|||ApoB-48||-0.69|-2.91|0.0018
71890077|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-1.091||||0.0759|TWO_SIDED|95.0|-2.3|0.12|||ANCOVA|||ApoB-48||0.12|-2.30|0.0759
71890078|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-0.887||||0.8451|TWO_SIDED|95.0|-9.89|8.11|||ANCOVA|||ApoB-100||8.11|-9.89|0.8451
71738128|NCT02967510|142989741|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.043|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.043
71738129|NCT02967510|142989742|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.022|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.022
71738130|NCT02967510|142989742|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.032|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.032
71660598|NCT00593736|142835170|SUPERIORITY_OR_OTHER|||||||0.276||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.276
71738131|NCT02967510|142989742|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
71738132|NCT02967510|142989743|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.176|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.176
71738133|NCT02967510|142989743|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.358|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.358
71738134|NCT02967510|142989743|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.21|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.21
71774712|NCT02819518|143049487|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0797|TWO_SIDED|95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, tumor PD-L1 status, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.05|0.76|0.0797
71774713|NCT02819518|143049488|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0563|TWO_SIDED|95.0|0.72|1.04||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||1.04|0.72|0.0563
71774714|NCT02819518|143049489|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0093|TWO_SIDED|95.0|0.55|0.95||One-sided p-value based on log-rank test stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|Log Rank||Based on Cox regression model with treatment as a covariate stratified by chemotherapy on study, and prior treatment with same class of chemotherapy in the (neo)adjuvant setting.|||0.95|0.55|0.0093
71774715|NCT02819518|143049490|SUPERIORITY||Difference in ORR (%) vs. Control|3.8||||0.1413|TWO_SIDED|95.0|-3.2|10.6|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||10.6|-3.2|0.1413
71774716|NCT02819518|143049491|SUPERIORITY||Difference in ORR (%) vs. Control|6.1||||0.0725|TWO_SIDED|95.0|-2.1|14.0|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||14.0|-2.1|0.0725
71774717|NCT02819518|143049492|SUPERIORITY||Difference in ORR(%) vs. Control|12.1||||0.0213|TWO_SIDED|95.0|0.4|23.4|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo)adjuvant setting (yes vs no).|||23.4|0.4|0.0213
71774718|NCT02819518|143049496|SUPERIORITY||Difference in DCR (%) vs. control|4.7||||0.0966|TWO_SIDED|95.0|-2.4|11.8|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin), tumor PD-L1 status (CPS ≥1 vs CPS \<1) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||11.8|-2.4|0.0966
71774719|NCT02819518|143049497|SUPERIORITY||Difference in DCR (%) vs. Control|5.0||||0.1164|TWO_SIDED|95.0|-3.2|13.1|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||13.1|-3.2|0.1164
71890079|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-7.59||||0.0973|TWO_SIDED|95.0|-16.59|1.41|||ANCOVA|||ApoB-100||1.41|-16.59|0.0973
71738135|NCT02967510|142989744|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.106|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.106
71890080|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-3.418||||0.5|TWO_SIDED|95.0|-13.45|6.61|||ANCOVA|||ApoB-100||6.61|-13.45|0.5000
71890081|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-4.753||||0.0008|TWO_SIDED|95.0|-7.47|-2.03|||ANCOVA|||ApoCIII||-2.03|-7.47|0.0008
71890082|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-8.499|||<|0.0001|TWO_SIDED|95.0|-11.18|-5.82|||ANCOVA|||ApoCIII||-5.82|-11.18|<0.0001
71738136|NCT02967510|142989744|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.229|TWO_SIDED|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||1|0|=0.229
71660599|NCT00593736|142835170|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.430
71660600|NCT00593736|142835171|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.349
71660601|NCT00593736|142835171|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.203
71660602|NCT00593736|142835171|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.444
71660603|NCT00593736|142835172|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.581
71660604|NCT00593736|142835172|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.257
71660605|NCT00593736|142835172|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.688
71660606|NCT00593736|142835173|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.561
71660607|NCT00593736|142835173|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.595
71738137|NCT02967510|142989744|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.345|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.345
71660608|NCT00593736|142835173|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.795
71660609|NCT00593736|142835174|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
71774720|NCT02819518|143049498|SUPERIORITY||Difference in DCR (%) vs. Control|10.8||||0.0327|TWO_SIDED|95.0|-0.7|22.3|||Cochran-Mantel-Haenszel||Based on Miettinen \& Nurminen method stratified by chemotherapy on study (taxane vs gemcitabine/carboplatin) and prior treatment with same class of chemotherapy in the (neo) adjuvant setting (yes vs no).|||22.3|-0.7|0.0327
71890083|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-6.86|||<|0.0001|TWO_SIDED|95.0|-9.78|-3.93|||ANCOVA|||ApoCIII||-3.93|-9.78|<0.0001
71660610|NCT00593736|142835174|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.177
71660611|NCT00593736|142835174|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.044
71660612|NCT00593736|142835175|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.475
71660613|NCT00593736|142835175|SUPERIORITY_OR_OTHER|||||||0.635||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.635
71660614|NCT00593736|142835175|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.782
71660615|NCT00593736|142835176|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.192
71890084|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-16.8||||0.0003|TWO_SIDED|95.0|-25.8|-7.85|||ANCOVA|||ApoA1||-7.85|-25.80|0.0003
71890085|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-44.07|-26.24|||ANCOVA|||ApoA1||-26.24|-44.07|<0.0001
71774721|NCT01505647|143049507|NON_INFERIORITY_OR_EQUIVALENCE|The GMT induced by ZOSTAVAX™ (AMP) vaccine is statistically non-inferior to that induced by the current process vaccine if the lower bound of the 95% confidence interval of the GMT ratio is \>0.67.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.98|1.2||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||The hypothesis tested is that the GMT at Week 6 postvaccination with ZOSTAVAX™ (AMP) vaccine is non-inferior to that with the current process vaccine||1.20|0.98|<0.001
71774722|NCT01505647|143049508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|t-test, 1 sided|||The hypothesis tested was that ZOSTAVAX™ (AMP) induces an acceptable GMFR in VZV antibody titer from prevaccination to 6 weeks postvaccination||||<0.001
71774723|NCT04755283|143049512|SUPERIORITY||Hazard Ratio (HR)|0.314|||<|0.001|TWO_SIDED|95.0|0.192|0.513|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.513|0.192|<0.001
71738138|NCT02967510|142989745|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.026|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.026
71774724|NCT04755283|143049512|SUPERIORITY||Hazard Ratio (HR)|0.382|||<|0.001|TWO_SIDED|95.0|0.243|0.602|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.602|0.243|<0.001
71774725|NCT04755283|143049513|SUPERIORITY||Hazard Ratio (HR)|0.263|||<|0.001|TWO_SIDED|95.0|0.121|0.572|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.572|0.121|<0.001
71774726|NCT04755283|143049513|SUPERIORITY||Hazard Ratio (HR)|0.325||||0.001|TWO_SIDED|95.0|0.159|0.663|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.663|0.159|0.001
71774727|NCT04755283|143049514|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.332|0.638|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.638|0.332|<0.001
71774728|NCT04755283|143049514|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.01|TWO_SIDED|95.0|0.512|0.912|||Stratified Log Rank Test|Stratified for stratification factors|Cox Proportional Hazards Model Adjusted for Stratification Factors|||0.912|0.512|0.010
71774729|NCT01828320|143049515|SUPERIORITY||d (effect size)|-0.08||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.34
71774730|NCT01828320|143049516|SUPERIORITY||d (effect size)|-0.06||||0.93|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.93
71774731|NCT01828320|143049517|SUPERIORITY||d (effect size)|-0.5||||0.01|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.01
71774732|NCT01828320|143049518|SUPERIORITY||d (effect size)|0.18||||0.17|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.17
71833414|NCT02217904|143171478|SUPERIORITY||Posterior mean difference|-1.28|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
71774733|NCT01828320|143049519|SUPERIORITY||d (effect size)|0.07||||0.31|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.31
71774734|NCT01828320|143049520|SUPERIORITY||d (effect size)|0.001||||0.8|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.80
71774735|NCT01828320|143049521|SUPERIORITY||d (effect size)|0.04||||0.96|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.96
71774736|NCT01828320|143049522|SUPERIORITY||d (effect size)|-0.05||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
71774737|NCT01828320|143049523|SUPERIORITY||d (effect size)|0.35||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
71774738|NCT01828320|143049524|SUPERIORITY||d (effect size)|0.28||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
71833415|NCT02217904|143171478|SUPERIORITY||Posterior mean difference|-1.18|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was \>99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.||||
71660616|NCT00593736|142835176|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.618
71660617|NCT00593736|142835176|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.152
71774739|NCT01828320|143049525|SUPERIORITY||d (effect size)|0.29||||0.04|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.04
71660618|NCT00593736|142835177|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.379
71774740|NCT01828320|143049526|SUPERIORITY||d (effect size)|-0.44||||0.03|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.03
71833416|NCT05930782|143171489|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of Cmax falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|73.9|||||TWO_SIDED|90.0|48.32|113.02||||||||113.02|48.32|
71833417|NCT05930782|143171490|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratio (GMR)|75.41|||||TWO_SIDED|90.0|56.46|100.71||||||||100.71|56.46|
71660619|NCT00593736|142835177|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.057
71660620|NCT00593736|142835177|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.808
71660621|NCT00593736|142835178|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.284
71660622|NCT00593736|142835178|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.344
71660623|NCT00593736|142835178|SUPERIORITY_OR_OTHER|||||||0.558||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.558
71774741|NCT01828320|143049527|SUPERIORITY||d (effect size)|0.07||||0.71|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.71
71774742|NCT01828320|143049528|SUPERIORITY||d (effect size)|0.02||||0.83|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.83
71774743|NCT01828320|143049529|SUPERIORITY||d (effect size)|-0.11||||0.85|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.85
71774744|NCT01828320|143049530|SUPERIORITY||d (effect size)|-0.55||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
71833418|NCT05930782|143171491|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|86.45|||||TWO_SIDED|90.0|68.16|109.63||||||||109.63|68.16|
71660624|NCT00593736|142835179|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.867
71660625|NCT00593736|142835179|SUPERIORITY_OR_OTHER|||||||0.244||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.244
71660626|NCT00593736|142835179|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.620
71660627|NCT00593736|142835180|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.206
71660628|NCT00593736|142835180|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.559
71660629|NCT00593736|142835180|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.074
71660630|NCT00593736|142835181|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.796
71660631|NCT00593736|142835181|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.546
71660632|NCT00593736|142835181|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.479
71660633|NCT00593736|142835182|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.766
71660634|NCT00593736|142835182|SUPERIORITY_OR_OTHER|||||||0.912||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.912
71660635|NCT00593736|142835182|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.952
71660636|NCT00593736|142835183|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.722
71660637|NCT00593736|142835183|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.262
71660638|NCT00593736|142835183|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.717
71660639|NCT00593736|142835184|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.498
71660640|NCT00593736|142835184|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.664
71660641|NCT00593736|142835184|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.428
71660642|NCT00593736|142835185|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.519
71660643|NCT00593736|142835185|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.179
71660644|NCT00593736|142835185|SUPERIORITY_OR_OTHER|||||||0.935||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.935
71660645|NCT00593736|142835186|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.425
71660646|NCT00593736|142835186|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.406
71738139|NCT02967510|142989745|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.424|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.424
71738140|NCT02967510|142989745|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.414|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.414
71660647|NCT00593736|142835186|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.720
71660648|NCT00593736|142835187|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.294
71660649|NCT00593736|142835187|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.474
71660650|NCT00593736|142835187|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.999
71660651|NCT00593736|142835188|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.655
71660652|NCT00593736|142835188|SUPERIORITY_OR_OTHER|||||||0.331||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.331
71660653|NCT00593736|142835188|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.362
71660654|NCT00593736|142835189|SUPERIORITY_OR_OTHER|||||||0.684||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.684
71660655|NCT00593736|142835189|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.399
71738141|NCT02967510|142989746|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.36|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.36
71738142|NCT02967510|142989746|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.12|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.12
71738143|NCT02967510|142989746|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.266|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.266
71660656|NCT00593736|142835189|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.611
71660657|NCT00593736|142835190|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.157
71660658|NCT00593736|142835190|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.463
71660659|NCT00593736|142835190|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.774
71660660|NCT00593736|142835191|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.413
71660661|NCT00593736|142835191|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.093
71738144|NCT02967510|142989747|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.47|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.47
71890086|NCT03371355|143301951|SUPERIORITY||Least Squares Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-30.89|-11.39|||ANCOVA|||ApoA1||-11.39|-30.89|<0.0001
71833419|NCT05930782|143171492|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|77.67|||||TWO_SIDED|90.0|59.49|101.39||||||||101.39|59.49|
71660662|NCT00593736|142835191|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.982
71660663|NCT00593736|142835192|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.441
71660664|NCT00593736|142835192|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.082
71660665|NCT00593736|142835192|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.549
71660666|NCT00593736|142835193|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.860
71660667|NCT00593736|142835193|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.997
71660668|NCT00593736|142835193|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.834
71660669|NCT00593736|142835194|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.837
71660670|NCT00593736|142835194|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.321
71660671|NCT00593736|142835194|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.978
71660672|NCT00593736|142835195|SUPERIORITY_OR_OTHER|||||||0.513||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.513
71660673|NCT00593736|142835195|SUPERIORITY_OR_OTHER|||||||0.751||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.751
71660674|NCT00593736|142835195|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.242
71660675|NCT00593736|142835196|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.307
71660676|NCT00593736|142835196|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.765
71660677|NCT00593736|142835196|SUPERIORITY_OR_OTHER|||||||0.727||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.727
71890087|NCT03371355|143301952|SUPERIORITY||Least Squares Mean Difference|0.0128||||0.8299|TWO_SIDED|95.0|-0.1|0.13|||ANCOVA|||||0.13|-0.10|0.8299
71890088|NCT03371355|143301952|SUPERIORITY||Least Squares Mean Difference|-0.0144||||0.8102|TWO_SIDED|95.0|-0.13|0.1|||ANCOVA|||||0.10|-0.13|0.8102
71660678|NCT00593736|142835197|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.902
71660679|NCT00593736|142835197|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.590
71660680|NCT00593736|142835197|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.290
71890089|NCT03371355|143301952|SUPERIORITY||Least Squares Mean Difference|-0.0146||||0.8223|TWO_SIDED|95.0|-0.14|0.11|||ANCOVA|||||0.11|-0.14|0.8223
71738145|NCT02967510|142989747|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.137|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.137
71738146|NCT02967510|142989747|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.133|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.133
71738147|NCT02967510|142989748|SUPERIORITY||LS Mean Difference|0.74|||=|0.85|TWO_SIDED|95.0|-0.669|2.153|||ANCOVA|||||2.153|-0.669|=0.85
71738148|NCT02967510|142989748|SUPERIORITY||LS Mean Difference|0.87|||=|0.877|TWO_SIDED|95.0|-0.611|2.361|||ANCOVA|||||2.361|-0.611|=0.877
71738149|NCT02967510|142989748|SUPERIORITY||LS Mean Difference|-0.64|||=|0.178|TWO_SIDED|95.0|-2.009|0.728|||ANCOVA|||||0.728|-2.009|=0.178
71738150|NCT02967510|142989749|SUPERIORITY||LS Mean Difference|-0.16|||=|0.323|TWO_SIDED|95.0|-0.854|0.531|||ANCOVA|||||0.531|-0.854|=0.323
71738151|NCT02967510|142989749|SUPERIORITY||LS Mean Difference|-0.22|||=|0.272|TWO_SIDED|95.0|-0.917|0.484|||ANCOVA|||||0.484|-0.917|=0.272
71738152|NCT02967510|142989749|SUPERIORITY||LS Mean Difference|-0.6|||=|0.043|TWO_SIDED|95.0|-1.29|0.084|||ANCOVA|||||0.084|-1.29|=0.043
71738153|NCT02967510|142989750|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.009|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.009
71890090|NCT03371355|143301953|SUPERIORITY||Least Squares Mean Difference|7.8||||0.0604|TWO_SIDED|95.0|-0.35|16.02|||ANCOVA|||Lp(a)||16.02|-0.35|0.0604
71890091|NCT03371355|143301953|SUPERIORITY||Least Squares Mean Difference|1.6||||0.7048|TWO_SIDED|95.0|-6.61|9.74|||ANCOVA|||Lp(a)||9.74|-6.61|0.7048
71890092|NCT03371355|143301953|SUPERIORITY||Least Squares Mean Difference|-1.7||||0.7024|TWO_SIDED|95.0|-10.65|7.2|||ANCOVA|||Lp(a)||7.20|-10.65|0.7024
71890093|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-45.0|||<|0.0001|TWO_SIDED|95.0|-54.0|-33.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-33|-54|<0.0001
71890094|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-54|-69|<0.0001
71738154|NCT02967510|142989750|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.025|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.025
71738155|NCT02967510|142989750|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71738156|NCT02967510|142989751|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.04|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.04
71738157|NCT02967510|142989751|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.259|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.259
71738158|NCT02967510|142989751|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.104|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.104
71738159|NCT02967510|142989752|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71738160|NCT02967510|142989752|SUPERIORITY||Median Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71738161|NCT02967510|142989752|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71738162|NCT02967510|142989753|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|<0.001
71738163|NCT02967510|142989753|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.054|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|=0.054
71738164|NCT02967510|142989753|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|0|<0.001
71738165|NCT02967510|142989754|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.008|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.008
71738166|NCT02967510|142989754|SUPERIORITY||Median Difference (Final Values)|-1.0|||=|0.01|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.01
71738167|NCT02967510|142989754|SUPERIORITY||Median Difference (Final Values)|0.0|||=|0.001|TWO_SIDED|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval|||0|-1|=0.001
71738168|NCT02967510|142989755|SUPERIORITY||LS Mean Difference|-0.81|||<|0.001|TWO_SIDED|95.0|-1.071|-0.548|||ANCOVA|||||-0.548|-1.071|<0.001
71738169|NCT02967510|142989755|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.013|-0.484|||ANCOVA|||||-0.484|-1.013|<0.001
71738170|NCT02967510|142989755|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.916|-0.397|||ANCOVA|||||-0.397|-0.916|<0.001
71774745|NCT01828320|143049531|SUPERIORITY||d (effect size)|-0.33||||0.05|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.05
71774746|NCT01828320|143049532|SUPERIORITY||d (effect size)|0.04||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.88
71774747|NCT01828320|143049533|SUPERIORITY||d (effect size)|0.04||||0.97|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.97
71774748|NCT01828320|143049534|SUPERIORITY||d (effect size)|0.01||||0.88|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: Alone"||||0.88
71774749|NCT01828320|143049534|SUPERIORITY||d (effect size)|-0.18||||0.43|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a family member"||||0.43
71738171|NCT02967510|142989756|SUPERIORITY||LS Mean Difference|0.44|||<|0.001|TWO_SIDED|95.0|0.337|0.535|||ANCOVA|||||0.535|0.337|<0.001
71738172|NCT02967510|142989756|SUPERIORITY||LS Mean Difference|0.39|||<|0.001|TWO_SIDED|95.0|0.291|0.494|||ANCOVA|||||0.494|0.291|<0.001
71738173|NCT02967510|142989756|SUPERIORITY||LS Mean Difference|0.34|||<|0.001|TWO_SIDED|95.0|0.245|0.439|||ANCOVA|||||0.439|0.245|<0.001
71738174|NCT02967510|142989757|SUPERIORITY||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.575|-0.371|||ANCOVA|||||-0.371|-0.575|<0.001
71738175|NCT02967510|142989757|SUPERIORITY||LS Mean Difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.592|-0.383|||ANCOVA|||||-0.383|-0.592|<0.001
71738176|NCT02967510|142989757|SUPERIORITY||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA|||||-0.3|-0.5|<0.001
71738177|NCT00536471|142989767|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||0.051
71738178|NCT00536471|142989767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit||||||<0.001
71738179|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.013
71738180|NCT00536471|142989768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71738181|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.026
71660681|NCT00593736|142835198|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.685
71660682|NCT00593736|142835198|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.214
71660683|NCT00593736|142835198|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.055
71660684|NCT00593736|142835199|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.589
71660685|NCT00593736|142835199|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.156
71738182|NCT00536471|142989768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71738183|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.202
71738184|NCT00536471|142989768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71738185|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.027
71774750|NCT01828320|143049534|SUPERIORITY||d (effect size)|0.21||||0.37|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||"Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a peer"||||0.37
71774751|NCT01828320|143049535|SUPERIORITY||d (effect size)|0.29||||0.02|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.02
71774752|NCT01828320|143049536|SUPERIORITY||d (effect size)|0.07||||0.49|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|intent-to-treat, multilevel modeling|||||||0.49
71660686|NCT00593736|142835199|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.||||0.041
71774753|NCT01828320|143049537|SUPERIORITY||d (effect size)|0.11||||0.6|TWO_SIDED||||||intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.60
71774754|NCT01828320|143049538|SUPERIORITY||d (effect size)|0.08||||0.42|TWO_SIDED|||||Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random was used to examine continuous outcomes.|Intent-to-treat, multilevel modeling|||||||0.42
71660687|NCT03493386|142835201|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC (0-t)|||1.07|0.97|
71660688|NCT03493386|142835201|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||AUC(0-inf)|||1.07|0.97|
71738186|NCT00536471|142989768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71738187|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.076
71738188|NCT00536471|142989768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||<0.001
71738189|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.149
71774755|NCT01828320|143049539|SUPERIORITY||d (effect size)|0.4||||0.01|TWO_SIDED||||||Intent-to-treat, multilevel modeling|Using intent-to-treat, multilevel modeling with maximum likelihood estimation with the assumption of missing at random, to examine continuous outcomes||||||0.01
71738190|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.062
71738191|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.629||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.629
71660689|NCT03493386|142835202|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Cmax|||1.12|0.97|
71738192|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.194
71738193|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.525||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.525
71738194|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.595
71738195|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.736
71738196|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.368
71738197|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.660
71833420|NCT05930782|143171493|EQUIVALENCE|The treatment was considered as bioequivalent if the 90% confidence interval (CI) for geometric least square mean ratios (GMR) of ln-transformed parameters falls within the acceptance range of 80.00 % to 125.00 %.|geometric least square mean ratios (GMR)|55.24|||||TWO_SIDED|90.0|6.03|113.02|||||For AUC0-inf, the GMR and 90% CI values were unreliable as there was only 1 calculable value for the Test (Group 2) and 2 values for the Reference (Group 1) products.|||113.02|6.03|
71833421|NCT01693120|143171501|SUPERIORITY||rate|1.6||||0.175|ONE_SIDED|95.0||4.9|||exact binomial test|||The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05||4.9||0.175
71833422|NCT01693120|143171502|OTHER|The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.|rate|52.6|||||TWO_SIDED|95.0|43.1|62.1||||||||62.1|43.1|
71833423|NCT01693120|143171503|OTHER|There was no prespecified hypothesis tested.|rate|90.7|||||TWO_SIDED|95.0|84.3|95.1||||||There was no prespecified hypothesis tested.||95.1|84.3|
71660690|NCT03493386|142835209|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-t)|||1.01|0.82|
71833424|NCT01693120|143171504|OTHER|There was no pre-specified hypothesis to test|rate|0.0|||||TWO_SIDED|95.0|0.0|6.1||||||There was no pre-specified hypothesis to test||6.1|0|
71833425|NCT03050814|143171513|OTHER||Hazard Ratio (HR)|1.061||||0.91|TWO_SIDED|95.0|0.38|2.966|||Kaplan Meier|Kaplan-Meier curves and a two-tailed log-rank test||||2.966|0.380|0.91
71890095|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-47.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ANGPTL3||-47|-66|<0.0001
71660691|NCT03493386|142835209|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||TWO_SIDED|90.0|0.82|1.01|||||AUC (0-inf)|||1.01|0.82|
71738198|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.334
71738199|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.568
71738200|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.216
71738201|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.646
71738202|NCT00536471|142989768|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit|Mixed Models Analysis|||||||0.275
71738203|NCT00536471|142989769|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
71738204|NCT00536471|142989769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline)|Mixed Models Analysis|||||||<0.001
71738205|NCT00536471|142989769|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.449
71738206|NCT00536471|142989769|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.167
71890096|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0309|TWO_SIDED|95.0|-16.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-1|-16|0.0309
71738207|NCT00536471|142989770|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.016
71738208|NCT00536471|142989770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
71738209|NCT00536471|142989770|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.653
71738210|NCT00536471|142989770|SUPERIORITY_OR_OTHER|||||||0.417||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.417
71738211|NCT00536471|142989771|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.204
71738212|NCT00536471|142989771|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
71738213|NCT00536471|142989771|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
71833426|NCT00324350|143171546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.678|TWO_SIDED|95.0|0.86|1.27||Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.|Regression, Cox|||The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.||1.27|0.86|0.678
71738214|NCT00536471|142989771|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
71738215|NCT00536471|142989772|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.023
71660692|NCT03493386|142835210|EQUIVALENCE|If the 90% CI of the ratio of geometric mean doesn't fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geomtric mean|0.89||||||90.0|0.73|1.08||||||||1.08|0.73|
71738216|NCT00536471|142989772|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.100
71738217|NCT00536471|142989772|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
71738218|NCT00536471|142989772|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.133
71738219|NCT00536471|142989773|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.332
71738220|NCT00536471|142989773|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.041
71738221|NCT00536471|142989773|SUPERIORITY_OR_OTHER|||||||0.775||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.775
71738222|NCT00536471|142989773|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
71738223|NCT00536471|142989774|SUPERIORITY_OR_OTHER|||||||0.624||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.624
71738224|NCT00536471|142989774|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
71738225|NCT00536471|142989774|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.787
71738226|NCT00536471|142989774|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.086
71738227|NCT00536471|142989775|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.099
71738228|NCT00536471|142989775|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.223
71833427|NCT00324350|143171547|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.49|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset||1.43|0.84|0.490
71833428|NCT00324350|143171548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.854|TWO_SIDED|95.0|0.88|1.11|||Mixed Models Analysis||The rate of height loss did not differ between groups (p = 0.573). Height loss of \>2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).|Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing \>2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403-410)||1.11|0.88|0.854
71833429|NCT02015520|143171551|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||||||0.38
71738229|NCT00536471|142989775|SUPERIORITY_OR_OTHER|||||||0.473||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.473
71738230|NCT00536471|142989775|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.233
71738231|NCT00536471|142989776|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.577
71738232|NCT00536471|142989776|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
71738233|NCT00536471|142989777|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.670
71738234|NCT00536471|142989777|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.059
71833430|NCT02015520|143171551|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71833431|NCT02015520|143171551|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71833432|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-concomitant Group. GMT Ratio is reported for Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 6||1.61|0.92|
71833433|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.33|||||TWO_SIDED|95.0|1.01|1.75|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 11||1.75|1.01|
71833434|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 16||1.82|1.02|
71738235|NCT00536471|142989777|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.930
71738236|NCT00536471|142989777|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.567
71738237|NCT00536471|142989778|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.896
71738238|NCT00536471|142989778|SUPERIORITY_OR_OTHER|||||||0.796||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.796
71738239|NCT00536471|142989778|SUPERIORITY_OR_OTHER|||||||0.571||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.571
71738240|NCT00536471|142989778|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.381
71738241|NCT00536471|142989779|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.038
71738242|NCT00536471|142989779|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
71738243|NCT00536471|142989779|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.665
71774756|NCT05108922|143049573|SUPERIORITY||Odds Ratio (OR)|29.26|||<|0.001|TWO_SIDED|95.0|5.3|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, Apolipoprotein (ApoE) ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|5.30|<0.001
71774757|NCT05108922|143049574|SUPERIORITY||Odds Ratio (OR)|15.18||||0.008|TWO_SIDED|95.0|2.04|100.0|||Regression, Logistic|||Analysis was based on logistic regression model with treatment, ApoE ε4 Carrier Status, baseline amyloid Level, baseline age as factors.||100.0|2.04|0.008
71774758|NCT05108922|143049575|SUPERIORITY||LS Mean difference (Final Values)|-45.691|STANDARD_ERROR_OF_MEAN|4.6132|<|0.001|TWO_SIDED|95.0|-54.84|-36.54||Analysis between treatment group comparison p-value using analysis of covariance (ANCOVA) model for endpoint measures: Change (CHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-36.54|-54.84|<0.001
71774759|NCT05108922|143049576|SUPERIORITY||LS Mean difference (Final Values)|-48.213|STANDARD_ERROR_OF_MEAN|4.9276|<|0.001|TWO_SIDED|95.0|-57.99|-38.44||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: Percent change (PCHG) = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-38.44|-57.99|<0.001
71774760|NCT05108922|143049577|SUPERIORITY||LS Mean difference (Final Values)|-40.252|STANDARD_ERROR_OF_MEAN|10.551|<|0.001|TWO_SIDED|95.0|-61.87|-18.64||Analysis between treatment group comparison p-value using ANCOVA model for endpoint measures: CHG = Baseline + ApoE ε4 Carrier Status + Baseline Age + Treatment|ANCOVA|||||-18.64|-61.87|<0.001
71774761|NCT05108922|143049578|SUPERIORITY||LS Mean difference (Final Values)|-23.97|STANDARD_ERROR_OF_MEAN|4.231|<|0.001|TWO_SIDED|95.0|-32.35|-15.6||Analysis between treatment group comparison p-value using mixed model for repeated measures (MMRM) model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-15.60|-32.35|<0.001
71774762|NCT05108922|143049579|SUPERIORITY||LS Mean difference (Final Values)|-25.82|STANDARD_ERROR_OF_MEAN|4.381|<|0.001|TWO_SIDED|95.0|-34.49|-17.15||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-17.15|-34.49|<0.001
71774763|NCT05108922|143049580|SUPERIORITY||Odds Ratio (OR)|8.38|||<|0.001|TWO_SIDED|95.0|3.37|20.81||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured|Regression, Logistic|||||20.81|3.37|<0.001
71774764|NCT05108922|143049581|SUPERIORITY||Odds Ratio (OR)|37.73|||<|0.001|TWO_SIDED|95.0|5.71|99.99||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Regression, Logistic|||||99.99|5.71|<.001
71774765|NCT05108922|143049582|SUPERIORITY||LS Mean difference (Final Values)|-26.75|STANDARD_ERROR_OF_MEAN|6.479|<|0.001|TWO_SIDED|95.0|-39.78|-13.73||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-13.73|-39.78|<0.001
71774766|NCT05108922|143049583|SUPERIORITY||LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187||0.0558|TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|0.0558
71774767|NCT05108922|143049584|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids|LS Mean difference (Final Values)|-7.931|STANDARD_ERROR_OF_MEAN|4.1187|||TWO_SIDED|95.0|-16.06|0.199||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||0.199|-16.060|
71890097|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-19.0|||<|0.0001|TWO_SIDED|95.0|-26.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-12|-26|<0.0001
71774768|NCT05108922|143049585|SUPERIORITY||LS Mean difference (Final Values)|-12.04|STANDARD_ERROR_OF_MEAN|4.12||0.004|TWO_SIDED|95.0|-20.19|-3.88||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-3.88|-20.19|0.004
71774769|NCT05108922|143049586|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71774770|NCT05108922|143049587|SUPERIORITY||LS Mean difference (Final Values)|-13.45|STANDARD_ERROR_OF_MEAN|4.3||0.002|TWO_SIDED|95.0|-21.96|-4.93||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-4.93|-21.96|0.002
71774771|NCT05108922|143049588|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.001|TWO_SIDED|95.0|1.93|11.34||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||11.34|1.93|<0.001
71774772|NCT05108922|143049589|SUPERIORITY||Odds Ratio (OR)|6.34||||0.022|TWO_SIDED|95.0|1.32|30.54||Analysis was based on logistic regression model with 1 (Screening) value, ApoE4 Status, Age, Treatment, Time, and Treatment-by-time interaction as factors. Variance-Covariance structure = Unstructured.|Regression, Logistic|||||30.54|1.32|0.022
71774773|NCT05108922|143049590|SUPERIORITY||LS Mean difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|6.333||0.028|TWO_SIDED|95.0|-27.07|-1.59||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||-1.59|-27.07|0.028
71774774|NCT05108922|143049591|NON_INFERIORITY|Non-inferiority margin of interest: 5 Centiloids.|LS Mean difference (Final Values)|7.831|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-0.226|15.889||Analysis between treatment group comparison p-value using MMRM model for Treatment + Visit + Treatment\*Visit + ApoE4 Carrier Status + Baseline Brain Amyloid Level + Baseline Age.|Mixed Models Analysis|||||15.889|-0.226|
71890098|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-25.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-9|-25|<0.0001
71738244|NCT00536471|142989779|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.253
71738245|NCT00536471|142989780|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
71738246|NCT00536471|142989780|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.312
71738247|NCT00536471|142989780|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
71738248|NCT00536471|142989780|SUPERIORITY_OR_OTHER|||||||0.913||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.913
71738249|NCT00536471|142989781|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
71738250|NCT00536471|142989781|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.216
71738251|NCT00536471|142989781|SUPERIORITY_OR_OTHER|||||||0.853||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.853
71738252|NCT00536471|142989781|SUPERIORITY_OR_OTHER|||||||0.908||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.908
71738253|NCT00536471|142989782|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
71890099|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|6.0||||0.4016|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||21|-7|0.4016
71738254|NCT00536471|142989782|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
71738255|NCT00536471|142989782|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.414
71738256|NCT00536471|142989782|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.717
71738257|NCT00536471|142989783|SUPERIORITY_OR_OTHER|||||||0.78||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.780
71738258|NCT00536471|142989783|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.152
71738259|NCT00536471|142989783|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.637
71738260|NCT00536471|142989783|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.024
71738261|NCT00536471|142989784|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.517
71738262|NCT00536471|142989784|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.256
71738263|NCT00536471|142989784|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71738264|NCT00536471|142989784|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
71738265|NCT00536471|142989785|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.741
71738266|NCT00536471|142989785|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.722
71738267|NCT00536471|142989785|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71890100|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2589|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||6|-18|0.2589
71738268|NCT00536471|142989785|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
71890101|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.0616|TWO_SIDED|95.0|-24.0|1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||1|-24|0.0616
71660693|NCT00289536|142835287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1662|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log initial recovery will be the same in each dose group.||||0.1662
71660694|NCT00289536|142835288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0965||||||No adjustments were made for multiple comparisons.|ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log AUC/dose will be the same in each dose group.||||0.0965
71660695|NCT00289536|142835289|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean terminal half-life will be the same in each dose group.||||0.5057
71738269|NCT00536471|142989786|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
71738270|NCT00536471|142989786|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.949
71738271|NCT00536471|142989786|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71738272|NCT00536471|142989786|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.268
71738273|NCT00536471|142989787|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.682
71738274|NCT00536471|142989787|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
71890102|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.1918|TWO_SIDED|95.0|-18.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||4|-18|0.1918
71660696|NCT00289536|142835297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7048||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: Relationship of initial recovery to pre-infusion level of VWF:Rco with dose groups combined.||||0.7048
71660697|NCT00289536|142835297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0322||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Rco with dose groups combined.||||.0322
71660698|NCT00289536|142835297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Rco with dose groups combined.||||0.0056
71738275|NCT00536471|142989787|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.200
71738276|NCT00536471|142989787|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.813
71738277|NCT00536471|142989788|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.438
71738278|NCT00536471|142989788|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.018
71738279|NCT00536471|142989788|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71738280|NCT00536471|142989788|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71738281|NCT00536471|142989789|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.588
71738282|NCT00536471|142989789|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.758
71738283|NCT00536471|142989789|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71738284|NCT00536471|142989789|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71890103|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-32.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||-14|-32|<0.0001
71660699|NCT00289536|142835298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3696||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of initial recovery to pre-infusion level of VWF:Ag with dose groups combined.||||0.3696
71833435|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.25|||||TWO_SIDED|95.0|0.92|1.7|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 18||1.70|0.92|
71833436|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.21|||||TWO_SIDED|95.0|0.91|1.61|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 31||1.61|0.91|
71890104|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.1132|TWO_SIDED|95.0|-21.0|3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||3|-21|0.1132
71660700|NCT00289536|142835298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Ag with dose groups combined.||||0.0001
71660701|NCT00289536|142835298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Ag with dose groups combined.||||<0.0001
71660702|NCT00271154|142835310|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.||||<0.0001
71660703|NCT00271154|142835311|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group||||0.10
71660704|NCT02338193|142835317|SUPERIORITY||||||<|0.032|||||||ANOVA|||One Way ANOVA with Bonferroni contrast if p\>0.05||||<0.032
71660705|NCT02338193|142835318|SUPERIORITY||||||<|0.05|||||||ANOVA|One Way ANOVA with Bonferoni contrast test||||||<0.05
71660706|NCT02338193|142835319|SUPERIORITY||||||<|0.01|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.01
71660707|NCT02338193|142835320|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
71660708|NCT02338193|142835321|SUPERIORITY|||||||0.007|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.007
71660709|NCT02338193|142835322|SUPERIORITY|||||||0.023|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||0.023
71660710|NCT02338193|142835323|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
71660711|NCT02338193|142835324|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||>0.05
71660712|NCT02338193|142835325|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast||||<0.001
71660713|NCT02338193|142835326|SUPERIORITY||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.001
71660714|NCT02338193|142835327|SUPERIORITY||||||<|0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.004
71660715|NCT02338193|142835328|SUPERIORITY||||||<|0.02|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.02
71660716|NCT02338193|142835329|SUPERIORITY||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.012
71660717|NCT02338193|142835330|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||>0.05
71660718|NCT02338193|142835331|SUPERIORITY||||||<|0.028|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<0.028
71660719|NCT02338193|142835332|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||<.03
71660720|NCT03118570|142835382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed analysis of covariance (ANCOVA) model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.644
71660721|NCT03118570|142835382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.485
71660722|NCT03118570|142835382|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.404
71660723|NCT03118570|142835383|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.006
71660724|NCT03118570|142835383|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.190
71660725|NCT03118570|142835383|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.704
71890105|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-24.0||||0.0177|TWO_SIDED|95.0|-40.0|-5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-5|-40|0.0177
71833437|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.32|||||TWO_SIDED|95.0|0.98|1.77|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 33||1.77|0.98|
71833438|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.93|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 45||1.93|1.01|
71890106|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-38.0|||<|0.0001|TWO_SIDED|95.0|-51.0|-23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-23|-51|<0.0001
71890107|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0033|TWO_SIDED|95.0|-45.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-12|-45|0.0033
71890108|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0523|TWO_SIDED|95.0|-18.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||0|-18|0.0523
71890109|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-18.0||||0.0002|TWO_SIDED|95.0|-26.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-26|0.0002
71890110|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-19.0||||0.0004|TWO_SIDED|95.0|-28.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-28|0.0004
71738285|NCT00536471|142989790|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.507
71738286|NCT00536471|142989790|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.466
71738287|NCT00536471|142989790|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71738288|NCT00536471|142989790|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71738289|NCT00536471|142989791|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.487
71738290|NCT00536471|142989791|SUPERIORITY_OR_OTHER|||||||0.678||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.678
71738291|NCT00536471|142989791|SUPERIORITY_OR_OTHER|||||||0.692||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.692
71738292|NCT00536471|142989791|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.668
71738293|NCT00536471|142989792|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
71738294|NCT00536471|142989792|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.135
71738295|NCT00536471|142989792|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
71738296|NCT00536471|142989792|SUPERIORITY_OR_OTHER|||||||1||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||1.000
71738297|NCT00536471|142989793|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.175
71738298|NCT00536471|142989793|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
71738299|NCT00536471|142989793|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
71833439|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.45|||||TWO_SIDED|95.0|1.13|1.87|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 52||1.87|1.13|
71738300|NCT00536471|142989793|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
71738301|NCT00536471|142989794|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.675
71774775|NCT00739999|143049623|SUPERIORITY_OR_OTHER_LEGACY||Atorvastatin CL/F based on 70 kg BW|699.0|||||TWO_SIDED|95.0|570.0|881.0|||non-linear mixed-effects model|Measures of parameter estimation uncertainty (95% CI) were determined by non-parametric bootstrap analysis.||Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.||881|570|
71774776|NCT03875768|143049661|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.72||0.89|TWO_SIDED|95.0|-0.44|0.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size is 0.5. The investigators hypothesize that the intervention will lead to an increase in average DASH score of 2 units. The investigators used a standard deviation for 2 units for both intervention and attention control groups since higher variability may be observed with a bigger sample size than the pilot study.||0.50|-0.44|0.89
71774777|NCT03875768|143049662|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|13.0||0.26|TWO_SIDED|95.0|-5.3|1.4||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in systolic blood pressure (SBP) between intervention and control group is 0.6 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.4|-5.3|0.26
71738302|NCT00536471|142989794|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.139
71738303|NCT00536471|142989794|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.576
71774778|NCT03875768|143049663|SUPERIORITY||Mean Difference (Net)|-0.9|STANDARD_DEVIATION|8.3||0.39|TWO_SIDED|95.0|-3.1|1.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Results presented are unadjusted.||The expected effect size for change in diastolic blood pressure (DBP) between intervention and control group is 0.75 based on the pilot study. With a 90% power and a type I error rate (alpha) of .01, the investigators can detect the expected effect size with the proposed sample size of 121 per study arm.||1.2|-3.1|0.39
71833440|NCT05119855|143171559|OTHER|Geometric Mean Titer (GMT) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-HPV titers and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMT Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Titer (GMT) Ratio|1.2|||||TWO_SIDED|95.0|0.91|1.58|||||GMT Ratio is between Concomitant Group/Non-concomitant Group.|Anti-HPV 58||1.58|0.91|
71833441|NCT05119855|143171560|OTHER|Geometric Mean Concentration (GMC) Ratio with corresponding 2-sided 95% confidence interval (CI) was calculated using an analysis of variance model (ANOVA) with a response of log individual anti-SARS-CoV-2 concentrations and a fixed effect for the vaccination groups, Concomitant Group versus Non-Concomitant Group. GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.4|||||GMC Ratio is between Concomitant Group/Non-concomitant Group.|Geometric Mean Concentration (GMC) Ratio||1.40|0.99|
71833442|NCT02932579|143171567|SUPERIORITY||Mean Difference (Final Values)|13.0||||0.098|TWO_SIDED||||||t-test, 2 sided|||||||0.098
71890111|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4204|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-12|0.4204
71738304|NCT00536471|142989794|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.676
71738305|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.007
71738306|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.031
71738307|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.020
71738308|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.324
71833443|NCT02932579|143171568|SUPERIORITY||Risk Ratio (RR)|1.38||||0.74|TWO_SIDED|95.0|0.45|4.21|||Fisher Exact|||||4.21|0.45|0.740
71833444|NCT01000480|143171600|SUPERIORITY_OR_OTHER|||||||0.0645||95.0||||P-value for H0 which compared the investigational regimen to historical data.|maximum likelihood estimate|||Null hypothesis (H0): 1-year PFS ≤45% and the alternative hypothesis (H1): 1-year PFS ≥60%, at a 2-sided alpha level of 5%, assuming that PFS time followed an exponential distribution.||||0.0645
71833445|NCT05052996|143171606|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-6.8|11.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||11.6|-6.8|
71833446|NCT05052996|143171607|OTHER||Difference in percentage|-1.9|||||TWO_SIDED|95.0|-12.4|8.6|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||8.6|-12.4|
71738309|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
71738310|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
71738311|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.010
71738312|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.019
71738313|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.201
71738314|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.069
71738315|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.368
71738316|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.435
71738317|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.090
71774779|NCT00857415|143049679|SUPERIORITY_OR_OTHER||Correlation coefficient|0.78|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.58|0.89||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Correlation test||Asymptotic standard error and 95 percent CI used Fisher z-transformation.|Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.89|0.58|<0.0001
71890112|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0441|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||0|-16|0.0441
71890113|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1324|TWO_SIDED|95.0|-16.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||2|-16|0.1324
71738318|NCT00536471|142989795|SUPERIORITY_OR_OTHER|||||||0.313||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.313
71738319|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.639
71738320|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.584||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.584
71738321|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.251||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.251
71738322|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.265||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.265
71738323|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
71738324|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.257
71738325|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.426
71738326|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.234
71738327|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.765||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.765
71774780|NCT00857415|143049680|SUPERIORITY_OR_OTHER||Specificity|100.0|||||TWO_SIDED|95.0|91.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 3 blinded readers||100|91|
71774781|NCT01130103|143049683|SUPERIORITY_OR_OTHER||incident rate ratio|0.5||||0.01|TWO_SIDED|95.0|0.3|0.85|||Mixed Models Analysis|||caps total score at weeks 5 and 10||.85|.30|.01
71774782|NCT01130103|143049683|SUPERIORITY_OR_OTHER||incident rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.43|0.74|||Mixed Models Analysis|||rate of change in CAPS total from week 5 to week 10||.74|.43|<.001
71738328|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.522
71738329|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.986
71738330|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.602
71738331|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.110
71738332|NCT00536471|142989796|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.505
71738333|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.366||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.366
71833447|NCT05052996|143171608|OTHER||Difference in percentage|1.9|||||TWO_SIDED|95.0|-8.6|12.4|||||The difference in percentages between treatment groups and their 95% CI were calculated based on unconditional exact method using 2 inverted 1-sided tests.|||12.4|-8.6|
71774783|NCT01130103|143049687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.6||||0.03|TWO_SIDED|95.0|1.23|129.0|||Mixed Models Analysis|||treatment group effect: remission rate at weeks 5 and 10||129|1.23|.03
71890114|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-29.0||||0.1009|TWO_SIDED|95.0|-53.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||7|-53|0.1009
71738334|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.065
71738335|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.229||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.229
71738336|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.044
71738337|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.092
71738338|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.002
71738339|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score(Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.142
71738340|NCT00536471|142989797|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.005
71738341|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.921
71738342|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.895
71738343|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.789
71738344|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.761||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.761
71738345|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.519
71738346|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.755||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.755
71774784|NCT01130103|143049687|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.8||||0.007|TWO_SIDED|95.0|2.44|176.0|||Mixed Models Analysis|||rate of change over time in remission rate from week 5 to 10||176|2.44|0.007
71774785|NCT00943124|143049714|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.14||||||90.0|1.09|1.2||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.20|1.09|
71833448|NCT05052996|143171609|OTHER||difference in least squares means|-68.0||||0.3859|TWO_SIDED|95.0|-226.0|91.0|||ANOVA||P-value, difference in least squares means (Diff in LSM), and its 95% confidence interval (CI) were from ANOVA model with treatment group as a fixed effect in the model.|||91|-226|0.3859
71660726|NCT03118570|142835384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.011
71890115|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-52.0||||0.0005|TWO_SIDED|95.0|-68.0|-28.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||-28|-68|0.0005
71890116|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.3004|TWO_SIDED|95.0|-50.0|24.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-48||24|-50|0.3004
71890117|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.6135|TWO_SIDED|95.0|-10.0|7.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||7|-10|0.6135
71738347|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.829||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.829
71738348|NCT00536471|142989798|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.723
71738349|NCT00536471|142989799|SUPERIORITY_OR_OTHER|||||||0.753||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.753
71738350|NCT00536471|142989799|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.036
71890118|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.1127|TWO_SIDED|95.0|-15.0|2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||2|-15|0.1127
71890119|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.2576|TWO_SIDED|95.0|-14.0|4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB-100||4|-14|0.2576
71660727|NCT03118570|142835384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.047
71738351|NCT00536471|142989801|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.342
71890120|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0017|TWO_SIDED|95.0|-52.0|-16.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-16|-52|0.0017
71738352|NCT00536471|142989801|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-value for Direct Treatment Effect|Regression, Linear|||||||0.111
71738353|NCT00536471|142989803|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.302
71738354|NCT00536471|142989803|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.029
71738355|NCT00536471|142989803|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.325
71738356|NCT00536471|142989803|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.423
71738357|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.731
71738358|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
71738359|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.948||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.948
71738360|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.022
71738361|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.950
71738362|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.442
71660728|NCT03118570|142835384|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||||||0.756
71660729|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.329||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.329
71660730|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.953||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.953
71660731|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
71660732|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.644||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.644
71660733|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.485||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.485
71660734|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.404||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.404
71660735|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.827||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.827
71660736|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.459||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.459
71660737|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.022||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.022
71660738|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.821||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.821
71660739|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.911||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.911
71660740|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.152||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.152
71660741|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.668||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.668
71660742|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.109||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.109
71660743|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.358||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.358
71890121|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-68.0|-45.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-45|-68|<0.0001
71660744|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.742||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.742
71660745|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.567||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.567
71660746|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.43||||||Analysis is based on a log transformed ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.430
71660747|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.634||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.634
71660748|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.146||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.146
71660749|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.521||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.521
71660750|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.991||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.991
71660751|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.069||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.069
71660752|NCT03118570|142835385|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.625||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.625
71660753|NCT03118570|142835386|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.615||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.615
71738363|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.218
71738364|NCT00536471|142989804|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.648
71833449|NCT05052996|143171609|OTHER||difference in least squares means|13.0||||0.7085|TWO_SIDED|95.0|-56.0|82.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||82|-56|0.7085
71833450|NCT05052996|143171610|OTHER||difference in least squares means|33.0||||0.3477|TWO_SIDED|95.0|-37.0|103.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||103|-37|0.3477
71660754|NCT03118570|142835386|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.376||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.376
71660755|NCT03118570|142835386|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.259||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.259
71738365|NCT00536471|142989805|SUPERIORITY_OR_OTHER|||||||0.653||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.653
71738366|NCT00536471|142989805|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.016
71738367|NCT00536471|142989805|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.665
71738368|NCT00536471|142989805|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment\*Visit.|Mixed Models Analysis|||||||0.127
71738369|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.475
71738370|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.561||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.561
71738371|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.213||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.213
71833451|NCT05052996|143171611|OTHER||difference in least squares means|-5.0||||0.8849|TWO_SIDED|95.0|-76.0|66.0|||ANCOVA||P-value, difference in least squares means (Diff in LSM), and its 95% CI were from ANCOVA model with baseline value as a covariate and treatment as a fixed effect in the model.|||66|-76|0.8849
71833452|NCT03351699|143171623|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.53|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 78%.|||||
71660756|NCT03118570|142835386|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.253||||||Analysis is based on a log transformed ANCOVA model with change from baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.253
71660757|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.064||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.064
71660758|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.019||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.019
71660759|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.845||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.845
71660760|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.006
71738372|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.536||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.536
71738373|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.158
71833453|NCT03351699|143171623|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.73|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 95%.|||||
71890122|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-47.0|||<|0.0001|TWO_SIDED|95.0|-61.0|-29.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoCIII||-29|-61|<0.0001
71890123|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-11.0||||0.0193|TWO_SIDED|95.0|-20.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-2|-20|0.0193
71890124|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-26.0|||<|0.0001|TWO_SIDED|95.0|-33.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-19|-33|<0.0001
71890125|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0063|TWO_SIDED|95.0|-23.0|-4.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|ApoAI||-4|-23|0.0063
71738374|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.759
71890126|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-2.0||||0.8873|TWO_SIDED|95.0|-21.0|23.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||23|-21|0.8873
71660761|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.19||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.190
71660762|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.704||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.704
71660763|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.002||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.002
71660764|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.021||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.021
71738375|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.190
71660765|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.504||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.504
71660766|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.462||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.462
71660767|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.134||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.134
71660768|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.086
71660769|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.199||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.199
71738376|NCT00536471|142989806|SUPERIORITY_OR_OTHER|||||||0.852||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.852
71738377|NCT00536471|142989807|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.032
71738378|NCT00536471|142989807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||<0.001
71833454|NCT03351699|143171623|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.52|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 75%.|||||
71660770|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.219||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.219
71660771|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.112||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.112
71660772|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.086||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.086
71660773|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.245||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.245
71660774|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.232||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.232
71738379|NCT00536471|142989807|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.705
71738380|NCT00536471|142989807|SUPERIORITY_OR_OTHER|||||||0.388||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.388
71738381|NCT00536471|142989808|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.161
71738382|NCT00536471|142989808|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.198
71738383|NCT00536471|142989808|SUPERIORITY_OR_OTHER|||||||0.982||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.982
71738384|NCT00536471|142989808|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.407
71738385|NCT00536471|142989809|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.001
71833455|NCT03351699|143171623|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.75|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 96%.|||||
71774786|NCT00943124|143049715|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.11||||||90.0|1.05|1.16||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.16|1.05|
71833456|NCT04515641|143171647|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.96|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.96|0.58|
71833457|NCT04515641|143171648|OTHER||GMR|0.75|||||TWO_SIDED|90.0|0.58|0.98|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|0.98|0.58|
71833458|NCT04515641|143171649|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.38|1.14|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.14|0.38|
71833459|NCT04515641|143171656|OTHER||GMR|0.76|||||TWO_SIDED|90.0|0.57|1.0|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.00|0.57|
71833460|NCT04515641|143171657|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.58|1.03|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.03|0.58|
71833461|NCT04515641|143171658|OTHER||GMR|0.96|||||TWO_SIDED|90.0|0.63|1.46|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.46|0.63|
71833462|NCT04515641|143171659|OTHER||GMR|1.05|||||TWO_SIDED|90.0|0.65|1.71|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.71|0.65|
71833463|NCT04515641|143171660|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.59|1.26|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.26|0.59|
71833464|NCT04515641|143171661|OTHER||GMR|0.65|||||TWO_SIDED|90.0|0.42|1.01|||||Participants with Moderate Hepatic Impairment / Healthy Matched Control Participants|Geometric least-squares mean ratio (GMR)|GMR calculated using the mean square error referencing a t-distribution. Confidence limits exponentiated to obtain the 90% confidence interval.|1.01|0.42|
71833465|NCT03201562|143171673|SUPERIORITY||Odds Ratio (OR)|38.436||||0.0009|TWO_SIDED|90.0|6.262|235.936|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||235.936|6.262|0.0009
71833466|NCT03201562|143171673|SUPERIORITY||Odds Ratio (OR)|36.893||||0.0012|TWO_SIDED|90.0|5.936|229.31|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect.||||229.310|5.936|0.0012
71833467|NCT03201562|143171673|SUPERIORITY||Odds Ratio (OR)|1.042||||0.9298|TWO_SIDED|90.0|0.485|2.239|||Generalized Estimating Equation (GEE)|GEE model includes 3-line improvement as response variable with sequence, period, treatment as fixed effect, subject within sequence as random effect||||2.239|0.485|0.9298
71890127|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.4404|TWO_SIDED|95.0|-27.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||15|-27|0.4404
71890128|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB]|-1.0||||0.9665|TWO_SIDED|95.0|-22.0|27.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|FFA||27|-22|0.9665
71890129|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB]|-7.0||||0.4133|TWO_SIDED|95.0|-21.0|10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||10|-21|0.4133
71890130|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB]|-6.0||||0.475|TWO_SIDED|95.0|-20.0|11.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||11|-20|0.4750
71890316|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-11.54|STANDARD_ERROR_OF_MEAN|4.808||0.017|TWO_SIDED|95.0|-21.0|-2.08|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-2.08|-21.00|0.0170
71774787|NCT00943124|143049716|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.97||||||90.0|0.93|1.0||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.00|0.93|
71738386|NCT00536471|142989809|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.006
71738387|NCT00536471|142989809|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.231
71738388|NCT00536471|142989809|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.040
71738389|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.914
71738390|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.011
71738391|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.296
71738392|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.034
71738393|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
71738394|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.614||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.614
71738395|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.146
71738396|NCT00536471|142989810|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.877
71738397|NCT00536471|142989811|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.012
71738398|NCT00536471|142989811|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.045
71833468|NCT00393484|143171674|NON_INFERIORITY_OR_EQUIVALENCE|The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero.|Difference in proportion|25.67||||0.0006|TWO_SIDED|90.0|14.48|36.86||There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established.|Chi-squared|||A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir.||36.86|14.48|0.0006
71890131|NCT03371355|143301954|SUPERIORITY||Mean Difference in % CFB]|-4.0||||0.6354|TWO_SIDED|95.0|-20.0|15.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|Lp\[a\]||15|-20|0.6354
71890132|NCT03371355|143301955|SUPERIORITY||Least Squares Mean Difference|-17.2||||0.1799|TWO_SIDED|95.0|-42.53|8.1|||ANCOVA|||||8.10|-42.53|0.1799
71738399|NCT00536471|142989811|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.701
71738400|NCT00536471|142989811|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.081
71738401|NCT00536471|142989812|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.013
71738402|NCT00536471|142989812|SUPERIORITY_OR_OTHER|||||||0.672||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.672
71738403|NCT00536471|142989812|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.874
71738404|NCT00536471|142989812|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment\*Visit and Baseline\*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis|||||||0.390
71738405|NCT00536471|142989817|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Bilirubin - 12 Week Change.|ANOVA|||||||0.046
71738406|NCT00536471|142989817|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value for Creatinine - 12 Week Change.|ANOVA|||||||0.031
71738407|NCT00536471|142989817|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Uric Acid - 12 Week Change.|ANOVA|||||||0.003
71738408|NCT00536471|142989817|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value for Bilirubin - 9 Month Change.|ANOVA|||||||0.033
71833469|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|24.55||||0.0003|TWO_SIDED|90.0|14.45|34.66||Treatment comparisons were assessed using the same method used in the primary endpoint.|Chi-squared|||HBV DNA \<10\^3 copies/mL at 24 Weeks||34.66|14.45|0.0003
71833470|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|13.62||||0.0167|TWO_SIDED|90.0|4.85|22.38||Treatment comparisons were assessed using the same method as the primary endpoint.|Chi-squared|||HBV DNA \<10\^4 copies/mL at 24 Weeks||22.38|4.85|0.0167
71738409|NCT00536471|142989817|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Uric Acid - 9 Month Change.|ANOVA|||||||0.013
71738410|NCT00536471|142989818|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Hematocrit - 12 Week Change.|ANOVA|||||||0.037
71738411|NCT00536471|142989818|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Hematocrit - 9 Month Change.|ANOVA|||||||0.029
71738412|NCT00536471|142989819|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for MCV - 12 Week Change.|ANOVA|||||||0.013
71738413|NCT00536471|142989819|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for MCV - 9 Month Change.|ANOVA|||||||0.014
71738414|NCT00536471|142989820|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Chloride - 12 Week Change.|ANOVA|||||||0.022
71738415|NCT00536471|142989820|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for Urea Nitrogen - 12 Week Change.|ANOVA|||||||0.044
71738416|NCT00536471|142989820|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Chloride - 9 Month Change.|ANOVA|||||||0.004
71738417|NCT00536471|142989820|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for Cholesterol - 9 Month Change.|ANOVA|||||||0.045
71738418|NCT00536471|142989820|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Sodium - 9 Month Change.|ANOVA|||||||0.043
71738419|NCT00536471|142989821|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for 12 Week Change.|ANOVA|||||||0.017
71738420|NCT00536471|142989821|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for 9 Month Change.|ANOVA|||||||0.003
71833471|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24||||0.4467|TWO_SIDED|90.0|-2.62|11.1|||Chi-squared|||HBV DNA \<10\^5 at 24 Weeks||11.10|-2.62|0.4467
71833472|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|26.12||||0.0002|TWO_SIDED|90.0|15.87|36.36|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 48 Weeks||36.36|15.87|0.0002
71833473|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|20.09||||0.0009|TWO_SIDED|90.0|11.1|29.07|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 48 Weeks||29.07|11.10|0.0009
71833474|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|16.96||||0.0029|TWO_SIDED|90.0|8.43|25.5|||Chi-squared|||HBV DNA \<10\^5 at 48 Weeks||25.50|8.43|0.0029
71738421|NCT00536471|142989822|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
71738422|NCT00536471|142989823|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||ANOVA|||||||0.045
71738423|NCT00536471|142989824|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.041
71738424|NCT00536471|142989824|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.048
71738425|NCT00536471|142989825|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
71738426|NCT00536471|142989825|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Potassium - Low.|Fisher Exact|||||||0.049
71738427|NCT00536471|142989826|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Lymphocytes - High.|Fisher Exact|||||||0.012
71738428|NCT00536471|142989826|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Hemoglobin - Low.|Fisher Exact|||||||0.038
71738429|NCT00856544|142989851|SUPERIORITY_OR_OTHER||Percent difference|27.04|||<|0.0001|TWO_SIDED|95.0|17.94|36.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||36.13|17.94|<0.0001
71738430|NCT00856544|142989851|SUPERIORITY_OR_OTHER||Percent Difference|21.52|||<|0.0001|TWO_SIDED|95.0|12.39|30.65||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||30.65|12.39|<0.0001
71738431|NCT00856544|142989852|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.26||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.26|-0.44|<0.0001
71738432|NCT00856544|142989852|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.35|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.||-0.16|-0.35|<0.0001
71833475|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|35.27|||<|0.0001|TWO_SIDED|90.0|24.02|46.51|||Chi-squared|||HBV DNA \<10\^3 copies/mL at 96 Weeks||46.51|24.02|<0.0001
71833476|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|29.02|||<|0.0001|TWO_SIDED|90.0|18.07|39.97|||Chi-squared|||HBV DNA \<10\^4 copies/mL at 96 Weeks||39.97|18.07|<0.0001
71833477|NCT00393484|143171675|SUPERIORITY_OR_OTHER||Difference|24.33||||0.0006|TWO_SIDED|90.0|13.71|34.95|||Chi-squared|||HBV DNA \<10\^5 copies/mL at 96 Weeks||34.95|13.71|0.0006
71833478|NCT00393484|143171676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariates of treatment and baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from baseline were based on patients with measurements at both Baseline and Week 24.||||<0.0001
71833479|NCT00393484|143171676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 48.||||<0.0001
71833480|NCT00393484|143171676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at 96 Weeks.||||<0.0001
71833481|NCT00393484|143171676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 144.||||<0.0001
71833482|NCT00393484|143171676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 192.||||<0.0001
71833483|NCT00393484|143171676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 240.||||<0.0001
71833484|NCT00393484|143171678|SUPERIORITY_OR_OTHER||Difference|18.97||||0.0278|TWO_SIDED|90.0|5.22|32.73|||Chi-squared||At 24 Weeks|||32.73|5.22|0.0278
71833485|NCT00393484|143171678|SUPERIORITY_OR_OTHER||Difference|26.34||||0.0014|TWO_SIDED|90.0|13.65|39.03|||Chi-squared||At 48 Weeks|||39.03|13.65|0.0014
71833486|NCT00393484|143171678|SUPERIORITY_OR_OTHER||Difference|35.94|||<|0.0001|TWO_SIDED|90.0|23.35|48.52|||Chi-squared||At 96 Weeks|||48.52|23.35|<0.0001
71833487|NCT00393484|143171684|SUPERIORITY_OR_OTHER||Difference|33.71|||<|0.0001|TWO_SIDED|90.0|22.52|44.89|||Chi-squared||At 48 Weeks|||44.89|22.52|<0.0001
71833488|NCT00393484|143171684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.21|||<|0.0001|TWO_SIDED|90.0|34.8|57.61|||Chi-squared||At 96 Weeks|||57.61|34.80|<0.0001
71833489|NCT00393484|143171684|SUPERIORITY_OR_OTHER||Difference|33.48||||0.0003|TWO_SIDED|90.0|19.31|47.65|||Chi-squared||At 144 Weeks|||47.65|19.31|0.0003
71833490|NCT00393484|143171684|SUPERIORITY_OR_OTHER||Difference|44.64|||<|0.0001|TWO_SIDED|90.0|31.17|58.11|||Chi-squared||At 192 Weeks|||58.11|31.17|<0.0001
71833491|NCT00393484|143171684|SUPERIORITY_OR_OTHER||Difference|52.23|||<|0.0001|TWO_SIDED|90.0|39.54|64.93|||Chi-squared||At 240 Weeks|||64.93|39.54|<0.0001
71833492|NCT00393484|143171685|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Viral rebound at 96 weeks||||<0.0001
71833493|NCT02178098|143171691|SUPERIORITY||Least squares mean difference|-24.24|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-30.33|-18.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-18.15|-30.33|<0.0001
71833494|NCT02178098|143171692|SUPERIORITY||Least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.511||0.2808|TWO_SIDED|95.0|-4.62|1.35|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.35|-4.62|0.2808
71833495|NCT02178098|143171693|SUPERIORITY||Least squares mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.111||0.3461|TWO_SIDED|95.0|-3.25|1.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.15|-3.25|0.3461
71833496|NCT02178098|143171694|SUPERIORITY||Least squares mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.734||0.1852|TWO_SIDED|95.0|-5.74|1.12|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.12|-5.74|0.1852
71833497|NCT02178098|143171695|SUPERIORITY||Least squares mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.253||0.2481|TWO_SIDED|95.0|-3.93|1.03|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||1.03|-3.93|0.2481
71833498|NCT02178098|143171696|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.684||0.8181|TWO_SIDED|95.0|-3.72|2.94|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.94|-3.72|0.8181
71833499|NCT02178098|143171697|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.274||0.8817|TWO_SIDED|95.0|-2.33|2.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||2.71|-2.33|0.8817
71833500|NCT02178098|143171698|SUPERIORITY||Least squares mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.829||0.404|TWO_SIDED|95.0|-2.09|5.15|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||5.15|-2.09|0.4040
71833501|NCT02178098|143171699|SUPERIORITY||Least squares mean difference|0.79|STANDARD_ERROR_OF_MEAN|1.178||0.5061|TWO_SIDED|95.0|-1.54|3.11|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||3.11|-1.54|0.5061
71833502|NCT02178098|143171700|SUPERIORITY||Median Difference (Final Values)|-43.64|||<|0.0001|TWO_SIDED|95.0|-62.8|-25.21|||Wilcoxon Rank-Sum Test||The 95% confidence interval (CI) was calculated using Hodges-Lehmann analysis.|||-25.21|-62.80|<0.0001
71833503|NCT02178098|143171701|SUPERIORITY||Least squares mean difference|-16.67|STANDARD_ERROR_OF_MEAN|2.006|<|0.0001|TWO_SIDED|95.0|-20.63|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-12.70|-20.63|<0.0001
71833504|NCT02178098|143171702|SUPERIORITY||Least squares mean difference|-18.9|STANDARD_ERROR_OF_MEAN|2.624|<|0.0001|TWO_SIDED|95.0|-24.09|-13.71|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.71|-24.09|<0.0001
71833505|NCT02178098|143171703|SUPERIORITY||Least squares mean difference|-18.69|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED|95.0|-23.62|-13.77|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-13.77|-23.62|<0.0001
71833506|NCT02178098|143171704|SUPERIORITY||Median Difference (Final Values)|5.25||||0.3689|TWO_SIDED|95.0|-6.78|16.42|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||16.42|-6.78|0.3689
71890133|NCT03371355|143301955|SUPERIORITY||Least Squares Mean Difference|13.8||||0.2867|TWO_SIDED|95.0|-11.83|39.49|||ANCOVA|||||39.49|-11.83|0.2867
71890134|NCT03371355|143301955|SUPERIORITY||Least Squares Mean Difference|2.2||||0.8812|TWO_SIDED|95.0|-26.78|31.14|||ANCOVA|||||31.14|-26.78|0.8812
71738433|NCT00856544|142989853|SUPERIORITY_OR_OTHER||Percent difference|10.63|||<|0.0001|TWO_SIDED|95.0|5.8|15.45||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.45|5.80|<0.0001
71738434|NCT00856544|142989853|SUPERIORITY_OR_OTHER||Percent difference|6.42||||0.0038|TWO_SIDED|95.0|2.07|10.77||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.77|2.07|0.0038
71738435|NCT02920749|142989941|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
71738436|NCT02920749|142989942|SUPERIORITY_OR_OTHER||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.||||<0.05
71738437|NCT00596830|142989985|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.179||||0.064|TWO_SIDED|95.0|0.99|1.404||The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.|Log Rank|||||1.404|0.990|0.064
71738438|NCT00596830|142989986|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.103||||0.27|TWO_SIDED|95.0|0.925|1.315||2-sided p-value is from the unstratified log-rank test|Log Rank||HR was based on the Cox proportional hazards model|||1.315|0.925|0.270
71738439|NCT00596830|142989987|SUPERIORITY_OR_OTHER||Risk difference|-1.472||||0.685|TWO_SIDED|95.0|-8.6|5.6|||Chi-squared||Risk difference confidence interval was calculated based on a normal distribution.|||5.6|-8.6|0.685
71738440|NCT00880191|142990003|SUPERIORITY_OR_OTHER|||||||0.2344|TWO_SIDED||||||Fisher Exact|||Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher's exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.||||0.2344
71738441|NCT00880191|142990004|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||Fisher Exact|||The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents.||||0.3694
71738442|NCT01919801|142990029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||||||Test was performed using a weighted log-rank test called the Peto-Prentice test with a global 2-sided significance level of 5% after adjusting for stratification factors (race, and severity) in the ITT population.|Adjusted Peto-Prentice|||A total of 121 participants were analysed, however 3 participants did not receive the study medication and were censored at time 0.||||0.633
71738443|NCT01843062|142990039|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||The primary endpoint was to be considered statistically significant if the 2-sided p-value was less than 0.05. P-value and confidence intervals (CIs) were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
71738444|NCT01843062|142990040|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
71833507|NCT02178098|143171705|SUPERIORITY||Least squares mean difference|-8.18|STANDARD_ERROR_OF_MEAN|2.319||0.0006|TWO_SIDED|95.0|-12.76|-3.59|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-3.59|-12.76|0.0006
71833508|NCT02178098|143171706|SUPERIORITY||Median Difference (Final Values)|7.6||||0.3093|TWO_SIDED|95.0|-8.21|24.02|||Wilcoxon Rank-Sum Test||The 95% CI was calculated using Hodges-Lehmann analysis.|||24.02|-8.21|0.3093
71833509|NCT01553058|143171741|OTHER|Difference of Differences||||||0.795|||||||Regression, Linear|||||||0.795
71833510|NCT01553058|143171741|OTHER|Difference of differences||||||0.647|||||||Regression, Linear|||||||0.647
71833511|NCT01553058|143171742|OTHER|Difference of differences||||||0.386|||||||Regression, Linear|||||||0.386
71833512|NCT01553058|143171742|OTHER|Difference of Differences||||||0.28|||||||Regression, Linear|||||||0.280
71833513|NCT01553058|143171749|OTHER|Difference of Differences||||||0.357|||||||Regression, Linear|||||||0.357
71890135|NCT03371355|143301956|SUPERIORITY||Least Squares Mean Difference|-0.28||||0.3995|TWO_SIDED|95.0|-0.94|0.38|||ANCOVA|||||0.38|-0.94|0.3995
71890136|NCT03371355|143301956|SUPERIORITY||Least Squares Mean Difference|0.08||||0.8155|TWO_SIDED|95.0|-0.59|0.75|||ANCOVA|||||0.75|-0.59|0.8155
71890137|NCT03371355|143301956|SUPERIORITY||Least Squares Mean Difference|0.16||||0.6466|TWO_SIDED|95.0|-0.54|0.86|||ANCOVA|||||0.86|-0.54|0.6466
71890138|NCT03371355|143301957|SUPERIORITY||Least Squares Mean Difference|1.39||||0.7393|TWO_SIDED|95.0|-9.66|6.89|||ANCOVA|||||6.89|-9.66|0.7393
71660775|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.237||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.237
71660776|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.088
71660777|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.302||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.302
71660778|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.626||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.626
71660779|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.517||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 8||||0.517
71660780|NCT03118570|142835387|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.262||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.262
71738445|NCT01843062|142990041|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8205|TWO_SIDED|95.0|0.61|1.87||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.87|0.61|0.8205
71738446|NCT01843062|142990042|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6549|TWO_SIDED|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio \>1 favours selumetinib in combination with RAI.||1.73|0.42|0.6549
71738447|NCT01677858|142990043|OTHER||Maximum Tolerated Dose (mg/m²)|70.0|||||TWO_SIDED|||||||||||||
71738448|NCT00773747|142990059|SUPERIORITY||Cox Proportional Hazard|0.774|||=|0.01|TWO_SIDED|95.0|0.636|0.941|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||0.941|0.636|= 0.0100
71738449|NCT00773747|142990061|SUPERIORITY||Cox Proportional Hazard|0.858||||0.3496|TWO_SIDED|95.0|0.622|1.184|||Regression, Cox|||Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.||1.184|0.622|0.3496
71738450|NCT04260347|142990064|OTHER||Risk Ratio (RR)|1.064||||1|TWO_SIDED|95.0|0.345|1.784|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.784|0.345|1.000
71890139|NCT03371355|143301957|SUPERIORITY||Least Squares Mean Difference|-0.13||||0.9744|TWO_SIDED|95.0|-8.45|8.18|||ANCOVA|||||8.18|-8.45|0.9744
71890140|NCT03371355|143301957|SUPERIORITY||Least Squares Mean Difference|3.58||||0.4477|TWO_SIDED|95.0|-5.75|12.91|||ANCOVA|||||12.91|-5.75|0.4477
71660781|NCT03118570|142835388|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
71660782|NCT03118570|142835388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.004
71660783|NCT03118570|142835388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.080
71660784|NCT03118570|142835388|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
71660785|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.06||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.060
71660786|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.015||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.015
71738451|NCT04260347|142990065|OTHER||Risk Ratio (RR)|0.889||||0.254|TWO_SIDED|95.0|0.699|1.08|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.08|0.699|0.254
71738452|NCT04260347|142990066|OTHER||Risk Ratio (RR)|1.089||||0.28|TWO_SIDED|95.0|0.942|1.237|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.237|0.942|0.280
71738453|NCT04260347|142990067|OTHER||Standardized Mean Difference (SMD)|0.016||||0.916|TWO_SIDED|95.0|-0.096|0.128|||Wilcoxon (Mann-Whitney)||SMD = Difference in the mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.128|-0.096|0.916
71738454|NCT04260347|142990068|OTHER||Risk Ratio (RR)|1.066||||0.561|TWO_SIDED|95.0|0.872|1.261|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.261|0.872|0.561
71890141|NCT03371355|143301958|SUPERIORITY||Least Squares Mean Difference|-1.794||||0.471|TWO_SIDED|95.0|-6.72|3.14|||ANCOVA|||||3.14|-6.72|0.4710
71890142|NCT03371355|143301958|SUPERIORITY||Least Squares Mean Difference|0.26||||0.9169|TWO_SIDED|95.0|-4.68|5.2|||ANCOVA|||||5.20|-4.68|0.9169
71890143|NCT03371355|143301958|SUPERIORITY||Least Squares Mean Difference|2.133||||0.4484|TWO_SIDED|95.0|-3.44|7.7|||ANCOVA|||||7.70|-3.44|0.4484
71890144|NCT03371355|143301959|SUPERIORITY||Least Squares Mean Difference|-23.2||||0.0916|TWO_SIDED|95.0|-50.17|3.83|||ANCOVA|||||3.83|-50.17|0.0916
71890145|NCT03371355|143301959|SUPERIORITY||Least Squares Mean Difference|-11.4||||0.4032|TWO_SIDED|95.0|-38.51|15.63|||ANCOVA|||||15.63|-38.51|0.4032
71890146|NCT03371355|143301959|SUPERIORITY||Least Squares Mean Difference|1.9||||0.8959|TWO_SIDED|95.0|-27.56|31.45|||ANCOVA|||||31.45|-27.56|0.8959
71738455|NCT04260347|142990069|OTHER||Risk Ratio (RR)|1.231||||0.522|TWO_SIDED|95.0|0.707|1.756|||Chi-squared||Actilyse® (alteplase) pre-approval participants were used as reference group.|||1.756|0.707|0.522
71738456|NCT04260347|142990070|OTHER||Standardized Mean Difference (SMD)|-0.021||||0.81|TWO_SIDED|95.0|-0.133|0.091|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.091|-0.133|0.810
71738457|NCT04260347|142990071|OTHER||Standardized Mean Difference (SMD)|-0.085||||0.179|TWO_SIDED|95.0|-0.199|0.03|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.03|-0.199|0.179
71738458|NCT04260347|142990072|OTHER||Standardized Mean Difference (SMD)|0.042||||0.275|TWO_SIDED|95.0|-0.072|0.156|||Wilcoxon (Mann-Whitney)||SMD = Difference in mean between groups / Standard deviation Actilyse® (alteplase) pre-approval participants were used as reference group.|||0.156|-0.072|0.275
71738459|NCT03549104|142990086|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
71738460|NCT03549104|142990087|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
71738461|NCT03549104|142990088|OTHER||||||||||||||||||We will evaluate the effects of within-group and between-group differences from baseline (Week 0) to program completion (Week 8) to calculate effect sizes for sample size estimation for a future larger study.|||
71738462|NCT04164732|142990094|SUPERIORITY||Median Difference (Net)|0.61||||0.5506|TWO_SIDED|80.0|-0.71|1.94|||longitudinal mixed effects (MMRM) model|||||1.94|-0.71|0.5506
71738463|NCT01868334|142990112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between Baseline and Year 1 for RCCT study period||||||0.05
71738464|NCT01868334|142990112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for percentage point difference between Baseline and Year 1 for RCCT study period|Cochran-Armitage trend test|||||||0.05
71738465|NCT01868334|142990113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between pre and post intervention for Pre-post study period||||||0.05
71738466|NCT01868334|142990113|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||||||Cochran-Armitage trend tests for difference between pre and post changes in vaccination rates for Pre-Post study period|Cochran-Armitage trend test|||||||0.05
71738467|NCT02951429|142990114|SUPERIORITY||Difference of percentage of participants|3.06||||0.6527|TWO_SIDED|95.0|-11.3|17.97|||Chi-squared|||||17.97|-11.30|0.6527
71738468|NCT02951429|142990115|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.7568|TWO_SIDED|95.0|0.67|1.34|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.34|0.67|0.7568
71738469|NCT02951429|142990116|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.15|||Log Rank|Log-rank test based on the time to the first event to compare the two treatment arms.||||1.15|0.68|0.3760
71738470|NCT02951429|142990117|SUPERIORITY||Difference (95% CI)|2.85||||0.7046|TWO_SIDED|95.0|-12.13|17.84|||Chi-squared|||||17.84|-12.13|0.7046
71738471|NCT02951429|142990118|SUPERIORITY||Difference (95% CI)|0.94||||0.755|TWO_SIDED|95.0|0.62|1.41|||Log Rank|||||1.41|0.62|0.7550
71738472|NCT02951429|142990119|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9174|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.9174
71738473|NCT02951429|142990120|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7748|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||||1.62|0.70|0.7748
71738474|NCT02951429|142990121|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4258|TWO_SIDED|95.0|0.38|1.5|||Log Rank|||||1.50|0.38|0.4258
71738475|NCT02951429|142990123|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.3161|TWO_SIDED|95.0|0.31|1.47|||Log Rank|||||1.47|0.31|0.3161
71738476|NCT02951429|142990133|SUPERIORITY||Difference in mean change from baseline|-206.59||||0.5646|TWO_SIDED|95.0|-920.03|506.85|||Linear Mixed Effects Model|||||506.85|-920.03|0.5646
71738477|NCT02951429|142990134|SUPERIORITY||Median Difference (Final Values)|-3.33||||0.5255|TWO_SIDED|95.0|-9.98|2.36|||ANCOVA|Difference in mean change in total score: -4.22||||2.36|-9.98|0.5255
71738478|NCT02951429|142990135|SUPERIORITY||Median Difference (Final Values)|-6.0||||0.4263|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA|Difference in mean change in total score: -5.07||||6.00|-18.00|0.4263
71738479|NCT01620528|142990141|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738480|NCT01620528|142990141|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738481|NCT01620528|142990142|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738482|NCT01620528|142990142|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738483|NCT01620528|142990143|SUPERIORITY||Difference in LS Mean Change|-0.65|STANDARD_ERROR_OF_MEAN|0.155|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
71738484|NCT01620528|142990143|SUPERIORITY||Difference in LS Mean Change|-1.3|STANDARD_ERROR_OF_MEAN|0.156|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.||||< 0.001
71738485|NCT01620528|142990144|SUPERIORITY||Difference in LS Mean Change|-0.45|STANDARD_ERROR_OF_MEAN|0.074|<|0.001|TWO_SIDED|95.0|||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
71890147|NCT03371355|143301960|SUPERIORITY||Least Squares Mean Difference|-0.052||||0.3202|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||||0.05|-0.16|0.3202
71890148|NCT03371355|143301960|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.8485|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||||0.09|-0.11|0.8485
71890149|NCT03371355|143301960|SUPERIORITY||Least Squares Mean Difference|0.0314||||0.5812|TWO_SIDED|95.0|-0.08|0.14|||ANCOVA|||||0.14|-0.08|0.5812
71774788|NCT00943124|143049717|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.87|0.97||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.97|0.87|
71833514|NCT01553058|143171749|OTHER|Difference of Differences||||||0.496|||||||Regression, Linear|||||||0.496
71738486|NCT01620528|142990144|SUPERIORITY||Difference in Least Squares Mean|-1.32|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.||||< 0.001
71738487|NCT01620528|142990145|SUPERIORITY||Difference in LS Mean Change|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||0.004
71738488|NCT01620528|142990145|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.||||< 0.001
71738489|NCT01620528|142990146|SUPERIORITY||Difference in LS Mean Change|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.91|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||0.910
71738490|NCT01620528|142990146|SUPERIORITY||Difference in LS Mean Change|-0.26|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.||||< 0.001
71738491|NCT01620528|142990147|SUPERIORITY||Difference in LS Mean Change|-0.07|STANDARD_ERROR_OF_MEAN|0.056||0.185|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||0.185
71738492|NCT01620528|142990147|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.057|<|0.001|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.||||< 0.001
71738493|NCT01620528|142990148|SUPERIORITY||Difference in LS Mean Change|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.144|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.144
71738494|NCT01620528|142990148|SUPERIORITY||Difference in LS Mean Change|-0.2|STANDARD_ERROR_OF_MEAN|0.067||0.003|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.||||0.003
71738495|NCT01620528|142990149|SUPERIORITY||Difference in LS Mean Change|0.03|STANDARD_ERROR_OF_MEAN|0.037||0.424|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.424
71738496|NCT01620528|142990149|SUPERIORITY||Difference in LS Mean Change|-0.12|STANDARD_ERROR_OF_MEAN|0.038||0.002|TWO_SIDED||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.||||0.002
71738497|NCT01620528|142990150|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738498|NCT01620528|142990150|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738499|NCT01620528|142990151|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738500|NCT01620528|142990151|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738501|NCT01620528|142990152|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738502|NCT01620528|142990152|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738503|NCT01620528|142990153|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738504|NCT01620528|142990153|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738505|NCT01620528|142990154|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738506|NCT01620528|142990154|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738507|NCT01620528|142990155|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
71738508|NCT01620528|142990155|SUPERIORITY|||||||0.023|||||||Regression, Logistic|||||||0.023
71738509|NCT01620528|142990156|SUPERIORITY|||||||0.031|||||||Regression, Logistic|||||||0.031
71738510|NCT01620528|142990156|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738511|NCT01620528|142990157|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738512|NCT01620528|142990157|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738513|NCT01620528|142990158|SUPERIORITY|||||||0.005|||||||Regression, Logistic|||||||0.005
71738514|NCT01620528|142990158|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738515|NCT01620528|142990159|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
71738516|NCT01620528|142990159|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738517|NCT01620528|142990160|SUPERIORITY|||||||0.306|||||||Regression, Logistic|||||||0.306
71738518|NCT01620528|142990160|SUPERIORITY|||||||0.239|||||||Regression, Logistic|||||||0.239
71738519|NCT01620528|142990161|SUPERIORITY|||||||0.855|||||||Regression, Logistic|||||||0.855
71738520|NCT01620528|142990161|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
71738521|NCT01620528|142990162|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.010
71738522|NCT01620528|142990162|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738523|NCT01620528|142990163|SUPERIORITY|||||||0.061|||||||Regression, Logistic|||||||0.061
71738524|NCT01620528|142990163|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738525|NCT01620528|142990164|SUPERIORITY|||||||0.126|||||||Regression, Logistic|||||||0.126
71738526|NCT01620528|142990164|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||< 0.001
71738527|NCT01620528|142990165|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.65|-0.34|||mixed-effects model|||||-0.34|-0.65|< 0.001
71738528|NCT01620528|142990165|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
71738529|NCT01620528|142990166|SUPERIORITY||LS Mean of Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|97.5|-0.79|-0.49|||mixed-effects model|||||-0.49|-0.79|< 0.001
71738530|NCT01620528|142990166|SUPERIORITY||LS Mean of Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-1.51|-1.2|||mixed-effects model|||||-1.20|-1.51|< 0.001
71738531|NCT01620528|142990167|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|97.5|-0.83|-0.53|||mixed-effects model|||||-0.53|-0.83|< 0.001
71833515|NCT01553058|143171750|OTHER|Difference of Differences||||||0.897|||||||Regression, Linear|||||||0.897
71833516|NCT01553058|143171750|OTHER|Difference of differences||||||0.467|||||||Regression, Linear|||||||0.467
71833517|NCT01553058|143171751|OTHER|Difference of differences||||||0.089|||||||Regression, Linear|||||||0.089
71890150|NCT03371355|143301961|SUPERIORITY||Least Squares Mean Difference|0.43||||0.6157|TWO_SIDED|95.0|-1.28|2.15|||ANCOVA|||||2.15|-1.28|0.6157
71660787|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.795||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||0.795
71890151|NCT03371355|143301961|SUPERIORITY||Least Squares Mean Difference|0.01||||0.9869|TWO_SIDED|95.0|-1.66|1.69|||ANCOVA|||||1.69|-1.66|0.9869
71890152|NCT03371355|143301961|SUPERIORITY||Least Squares Mean Difference|-0.33||||0.7084|TWO_SIDED|95.0|-2.07|1.42|||ANCOVA|||||1.42|-2.07|0.7084
71890153|NCT03371355|143301962|SUPERIORITY||Least Squares Mean Difference|2.79||||0.4431|TWO_SIDED|95.0|-4.41|10.0|||ANCOVA|||SBP||10.00|-4.41|0.4431
71890154|NCT03371355|143301962|SUPERIORITY||Least Squares Mean Difference|2.08||||0.563|TWO_SIDED|95.0|-5.05|9.22|||ANCOVA|||SBP||9.22|-5.05|0.5630
71890155|NCT03371355|143301962|SUPERIORITY||Least Squares Mean Difference|-1.63||||0.6634|TWO_SIDED|95.0|-9.06|5.79|||ANCOVA|||SBP||5.79|-9.06|0.6634
71660788|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.011||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.011
71660789|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.047||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.047
71738532|NCT01620528|142990167|SUPERIORITY||LS Mean of Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|97.5|-1.54|-1.23|||mixed-effects model|||||-1.23|-1.54|< 0.001
71738533|NCT01620528|142990168|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.81|-0.49|||mixed-effects model|||||-0.49|-0.81|< 0.001
71738534|NCT01620528|142990168|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.49|-1.16|||mixed-effects model|||||-1.16|-1.49|< 0.001
71738535|NCT01620528|142990169|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.75|-0.43|||mixed-effects model|||||-0.43|-0.75|< 0.001
71738536|NCT01620528|142990169|SUPERIORITY||LS Mean of Difference|-1.41|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|97.5|-1.58|-1.25|||mixed-effects model|||||-1.25|-1.58|< 0.001
71738537|NCT01620528|142990170|SUPERIORITY||LS Mean of Difference|-24.07|STANDARD_ERROR_OF_MEAN|3.288|<|0.001|TWO_SIDED|97.5|-31.45|-16.69|||mixed-effects model|||||-16.69|-31.45|< 0.001
71738538|NCT01620528|142990170|SUPERIORITY||LS Mean of Difference|-31.01|STANDARD_ERROR_OF_MEAN|3.299|<|0.001|TWO_SIDED|97.5|-38.41|-23.6|||mixed-effects model|||||-23.60|-38.41|< 0.001
71738539|NCT01620528|142990171|SUPERIORITY||LS Mean of Difference|-30.79|STANDARD_ERROR_OF_MEAN|3.107||-30.79|TWO_SIDED|97.5|-37.77|-23.82|||mixed-effects model|||||-23.82|-37.77|-30.79
71738540|NCT01620528|142990171|SUPERIORITY||LS Mean of Difference|-63.78|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|97.5|-70.85|-56.71|||mixed-effects model|||||-56.71|-70.85|< 0.001
71738541|NCT01620528|142990172|SUPERIORITY||LS Mean of Difference|-32.21|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|97.5|-39.35|-25.08|||mixed-effects model|||||-25.08|-39.35|< 0.001
71738542|NCT01620528|142990172|SUPERIORITY||LS Mean of Difference|-64.94|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|97.5|-72.19|-57.68|||mixed-effects model|||||-57.68|-72.19|< 0.001
71660790|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.756||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||0.756
71660791|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.006||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.006
71660792|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.137||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.137
71738543|NCT01620528|142990173|SUPERIORITY||LS Mean of Difference|-29.94|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|97.5|-37.28|-22.59|||mixed-effects model|||||-22.59|-37.28|< 0.001
71738544|NCT01620528|142990173|SUPERIORITY||LS Mean of Difference|-61.9|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|97.5|-69.44|-54.36|||mixed-effects model|||||-54.36|-69.44|< 0.001
71738545|NCT01620528|142990174|SUPERIORITY||LS Mean of Difference|-28.63|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|97.5|-35.96|-21.31|||mixed-effects model|||||-21.31|-35.96|< 0.001
71738546|NCT01620528|142990174|SUPERIORITY||LS Mean of Difference|-66.5|STANDARD_ERROR_OF_MEAN|3.321|<|0.001|TWO_SIDED|97.5|-73.95|-59.04|||mixed-effects model|||||-59.04|-73.95|< 0.001
71738547|NCT01620528|142990175|SUPERIORITY||LS Mean of Difference|-21.39|STANDARD_ERROR_OF_MEAN|3.479|<|0.001|TWO_SIDED|97.5|-29.2|-13.57|||mixed-effects model|||||-13.57|-29.20|< 0.001
71738548|NCT01620528|142990175|SUPERIORITY||LS Mean of Difference|-60.78|STANDARD_ERROR_OF_MEAN|3.557|<|0.001|TWO_SIDED|97.5|-68.77|-52.79|||mixed-effects model|||||-52.79|-68.77|< 0.001
71738549|NCT01620528|142990176|SUPERIORITY||LS Mean of Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.036||0.111|TWO_SIDED|97.5|-0.14|0.02|||mixed-effects model|||||0.02|-0.14|0.111
71738550|NCT01620528|142990176|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.036||0.008|TWO_SIDED|97.5|-0.18|-0.01|||mixed-effects model|||||-0.01|-0.18|0.008
71890156|NCT03371355|143301962|SUPERIORITY||Least Squares Mean Difference|4.11||||0.0937|TWO_SIDED|95.0|-0.71|8.92|||ANCOVA|||DBP||8.92|-0.71|0.0937
71890157|NCT03371355|143301962|SUPERIORITY||Least Squares Mean Difference|3.49||||0.1522|TWO_SIDED|95.0|-1.31|8.28|||ANCOVA|||DBP||8.28|-1.31|0.1522
71890158|NCT03371355|143301962|SUPERIORITY||Least Squares Mean Difference|1.62||||0.5188|TWO_SIDED|95.0|-3.35|6.59|||ANCOVA|||DBP||6.59|-3.35|0.5188
71890159|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|0.57||||0.5299|TWO_SIDED|95.0|-1.24|2.39|||ANCOVA|||Weight||2.39|-1.24|0.5299
71738551|NCT01620528|142990177|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|97.5|-0.18|0.02|||mixed-effects model|||||0.02|-0.18|0.092
71738552|NCT01620528|142990177|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|97.5|-0.28|-0.08|||mixed-effects model|||||-0.08|-0.28|< 0.001
71738553|NCT01620528|142990178|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.017|TWO_SIDED|97.5|-0.23|-0.01|||mixed-effects model|||||-0.01|-0.23|0.017
71738554|NCT01620528|142990178|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|97.5|-0.41|-0.18|||mixed-effects model|||||-0.18|-0.41|< 0.001
71738555|NCT01620528|142990179|SUPERIORITY||LS Mean of Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.31|-0.07|||mixed-effects model|||||-0.07|-0.31|< 0.001
71738556|NCT01620528|142990179|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.51|-0.27|||mixed-effects model|||||-0.27|-0.51|< 0.001
71738557|NCT01620528|142990180|SUPERIORITY||LS Mean of Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.053||0.004|TWO_SIDED|97.5|-0.27|-0.03|||mixed-effects model|||||-0.03|-0.27|0.004
71738558|NCT01620528|142990180|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.52|-0.27|||mixed-effects model|||||-0.27|-0.52|< 0.001
71738559|NCT01620528|142990181|SUPERIORITY||LS Mean of Difference|-6.23|STANDARD_ERROR_OF_MEAN|2.748||0.024|TWO_SIDED|97.5|-12.4|-0.06|||mixed-effects model|||||-0.06|-12.40|0.024
71738560|NCT01620528|142990181|SUPERIORITY||LS Mean of Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.756||0.005|TWO_SIDED|97.5|-13.9|-1.53|||mixed-effects model|||||-1.53|-13.90|0.005
71738561|NCT01620528|142990182|SUPERIORITY||LS Mean of Difference|-5.69|STANDARD_ERROR_OF_MEAN|3.226||0.078|TWO_SIDED|97.5|-12.93|1.56|||mixed-effects model|||||1.56|-12.93|0.078
71738562|NCT01620528|142990182|SUPERIORITY||LS Mean of Difference|-13.72|STANDARD_ERROR_OF_MEAN|3.249|<|0.001|TWO_SIDED|97.5|-21.01|-6.42|||mixed-effects model|||||-6.42|-21.01|< 0.001
71738563|NCT01620528|142990183|SUPERIORITY||LS Mean of Difference|-8.47|STANDARD_ERROR_OF_MEAN|3.475||0.015|TWO_SIDED|97.5|-16.27|-0.66|||mixed-effects model|||||-0.66|-16.27|0.015
71738564|NCT01620528|142990183|SUPERIORITY||LS Mean of Difference|-22.49|STANDARD_ERROR_OF_MEAN|3.514|<|0.001|TWO_SIDED|97.5|-30.38|-14.6|||mixed-effects model|||||-14.60|-30.38|< 0.001
71738565|NCT01620528|142990184|SUPERIORITY||LS Mean of Difference|-14.11|STANDARD_ERROR_OF_MEAN|3.673|<|0.001|TWO_SIDED|97.5|-22.36|-5.87|||mixed-effects model|||||-5.87|-22.36|< 0.001
71738566|NCT01620528|142990184|SUPERIORITY||LS Mean of Difference|-30.41|STANDARD_ERROR_OF_MEAN|3.729|<|0.001|TWO_SIDED|97.5|-38.78|-22.04|||mixed-effects model|||||-22.04|-38.78|< 0.001
71738567|NCT01620528|142990185|SUPERIORITY||LS Mean of Difference|-11.55|STANDARD_ERROR_OF_MEAN|3.736||0.002|TWO_SIDED|97.5|-19.94|-3.16|||mixed-effects model|||||-3.16|-19.94|0.002
71774789|NCT00943124|143049718|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.02||||||90.0|0.99|1.04||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.04|0.99|
71738568|NCT01620528|142990185|SUPERIORITY||LS Mean of Difference|-29.68|STANDARD_ERROR_OF_MEAN|3.788|<|0.001|TWO_SIDED|97.5|-38.19|-21.18|||mixed-effects model|||||-21.18|-38.19|< 0.001
71738569|NCT01620528|142990186|SUPERIORITY||LS Mean of Difference|-12.37|STANDARD_ERROR_OF_MEAN|3.805||0.001|TWO_SIDED|97.5|-20.92|-3.83|||mixed-effects model|||||-3.83|-20.92|0.001
71738570|NCT01620528|142990186|SUPERIORITY||LS Mean of Difference|-29.97|STANDARD_ERROR_OF_MEAN|3.868|<|0.001|TWO_SIDED|97.5|-38.66|-21.28|||mixed-effects model|||||-21.28|-38.66|< 0.001
71738571|NCT01620528|142990187|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.052||0.038|TWO_SIDED|97.5|-0.22|0.01|||mixed-effects model|||||0.01|-0.22|0.038
71738572|NCT01620528|142990187|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.053||0.488|TWO_SIDED|97.5|-0.16|0.08|||mixed-effects model|||||0.08|-0.16|0.488
71738573|NCT01620528|142990188|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.252|TWO_SIDED|97.5|-0.2|0.07|||mixed-effects model|||||0.07|-0.20|0.252
71738574|NCT01620528|142990188|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.061||0.058|TWO_SIDED|97.5|-0.25|0.02|||mixed-effects model|||||0.02|-0.25|0.058
71738575|NCT01620528|142990189|SUPERIORITY||LS Mean of Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.069||0.009|TWO_SIDED|97.5|-0.34|-0.03|||mixed-effects model|||||-0.03|-0.34|0.009
71738576|NCT01620528|142990189|SUPERIORITY||LS Mean of Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|97.5|-0.5|-0.18|||mixed-effects model|||||-0.18|-0.50|< 0.001
71738577|NCT01620528|142990190|SUPERIORITY||LS Mean of Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.073||0.06|TWO_SIDED|97.5|-0.3|0.03|||mixed-effects model|||||0.03|-0.30|0.060
71738578|NCT01620528|142990190|SUPERIORITY||LS Mean of Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|97.5|-0.44|-0.1|||mixed-effects model|||||-0.10|-0.44|< 0.001
71738579|NCT01620528|142990191|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.074||0.118|TWO_SIDED|97.5|-0.28|0.05|||mixed-effects model|||||0.05|-0.28|0.118
71738580|NCT01620528|142990191|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|97.5|-0.48|-0.13|||mixed-effects model|||||-0.13|-0.48|< 0.001
71738581|NCT01620528|142990192|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.313|TWO_SIDED|97.5|-0.14|0.05|||mixed-effects model|||||0.05|-0.14|0.313
71738582|NCT01620528|142990192|SUPERIORITY||LS Mean of Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.044||0.006|TWO_SIDED|97.5|-0.22|-0.02|||mixed-effects model|||||-0.02|-0.22|0.006
71738583|NCT01620528|142990193|SUPERIORITY||LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.047||0.519|TWO_SIDED|97.5|-0.13|0.07|||mixed-effects model|||||0.07|-0.13|0.519
71738584|NCT01620528|142990193|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|97.5|-0.32|-0.11|||mixed-effects model|||||-0.11|-0.32|< 0.001
71738585|NCT01620528|142990194|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.053||0.037|TWO_SIDED|97.5|-0.23|0.01|||mixed-effects model|||||0.01|-0.23|0.037
71738586|NCT01620528|142990194|SUPERIORITY||LS Mean of Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|97.5|-0.41|-0.17|||mixed-effects model|||||-0.17|-0.41|< 0.001
71738587|NCT01620528|142990195|SUPERIORITY||LS Mean of Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.053||0.2|TWO_SIDED|97.5|-0.19|0.05|||mixed-effects model|||||0.05|-0.19|0.200
71774790|NCT00943124|143049719|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.08||||||90.0|1.02|1.14||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||1.14|1.02|
71774791|NCT00943124|143049720|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.77||||||90.0|0.72|0.82||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.82|0.72|
71774792|NCT00943124|143049721|NON_INFERIORITY_OR_EQUIVALENCE|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within \[0.80, 1.25\], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.89|0.94||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)||0.94|0.89|
71774793|NCT02992132|143049722|SUPERIORITY||Difference in LSM|5.1|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-4.8|15.0||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||15.0|-4.8|
71738588|NCT01620528|142990195|SUPERIORITY||LS Mean of Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.054|<|0.001|TWO_SIDED|97.5|-0.42|-0.18|||mixed-effects model|||||-0.18|-0.42|< 0.001
71738589|NCT01620528|142990196|SUPERIORITY||LS Mean of Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-0.72|-0.34|||ANOVA|||||-0.34|-0.72|< 0.001
71738590|NCT01620528|142990196|SUPERIORITY||LS Mean of Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.93|-0.56|||ANOVA|||||-0.56|-0.93|< 0.001
71738591|NCT01620528|142990197|SUPERIORITY||LS Mean of Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.58|-0.19|||ANOVA|||||-0.19|-0.58|< 0.001
71774794|NCT02992132|143049722|SUPERIORITY||Difference in LSM|1.0|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-8.5|10.5||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.||10.5|-8.5|
71774795|NCT03194503|143049731|SUPERIORITY||Odds Ratio (OR)|0.65||||0.015|TWO_SIDED|95.0|0.47|0.92|||t-test, 2 sided|||This statistical analysis applies to all three rows in the post-intervention column. ITT analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||0.92|0.47|0.015
71774796|NCT03194503|143049732|SUPERIORITY||Odds Ratio (OR)|0.77||||0.25|TWO_SIDED|95.0|0.5|1.2|||t-test, 2 sided|||This statistical analysis applies to all three rows and is a per-protocol analysis: Multivariable analysis for Any TIAEs, Severe TIAEs, and Severe desaturation(\>20%)||1.20|0.50|0.250
71774797|NCT01916967|143049737|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.17|||<|0.001|TWO_SIDED|95.0|-1.69|-0.65|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in least squares (LS) means of Desloratadine 5 mg and Placebo||-0.65|-1.69|<0.001
71774798|NCT01916967|143049737|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-1.13|||<|0.001|TWO_SIDED|95.0|-1.66|-0.61|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in LS means of Desloratadine 10 mg and Placebo||-0.61|-1.66|<0.001
71774799|NCT00337350|143049748|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANCOVA|||||||0.08
71774800|NCT00337350|143049749|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||||||.05
71774801|NCT00337350|143049750|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||||||0.21
71774802|NCT03911154|143049777|OTHER|We used linear mixed effect models (in SAS version 9.4, SAS Institute, Cary, NC) with random subject intercept to account for the clustered nature of the data. The model included factors for stimulus modality (4 levels), sleep restriction night (4 levels), and their interaction.|Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.353||0.36|TWO_SIDED|95.0|-0.403|1.06|||Mixed Models Analysis|||Number of lapses of attention were averaged across assessments within each day and the statistical analysis adjusted for baseline.||1.060|-0.403|0.36
71774803|NCT03911154|143049777|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.307|STANDARD_ERROR_OF_MEAN|0.441||0.49|TWO_SIDED|95.0|-1.222|0.608|||Mixed Models Analysis|||Number of lapses of attention upon emergent awakening||0.608|-1.222|0.49
71774804|NCT03911154|143049778|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.455|STANDARD_ERROR_OF_MEAN|2.797||0.87|TWO_SIDED|95.0|-5.4|6.31|||Mixed Models Analysis|||||6.310|-5.400|0.87
71774805|NCT03911154|143049779|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.112|STANDARD_ERROR_OF_MEAN|0.798||0.89|TWO_SIDED|95.0|-1.767|1.543|||Mixed Models Analysis|||Number correct on the DSST was averaged across DSST administrations within each day and was adjusted for baseline performance.||1.543|-1.767|0.89
71774806|NCT03911154|143049780|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.381||0.76|TWO_SIDED|95.0|-0.919|0.678|||Mixed Models Analysis|||Number correct on the DST was averaged across DST administrations within each day and adjusted for baseline.||0.678|-0.919|0.76
71774807|NCT03911154|143049781|OTHER|Linear mixed effects model with a random subject intercept.|Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.179||0.64|TWO_SIDED|95.0|-0.286|0.456|||Mixed Models Analysis|||The mean weighted score on the ROBoT was adjusted for baseline.||0.456|-0.286|0.64
71774808|NCT02035475|143049782|SUPERIORITY_OR_OTHER|||||||0.412|||||||McNemar|||The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.||||0.412
71774809|NCT02047227|143049816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.235||||0.054|TWO_SIDED|95.0|-0.4741|0.003|||Poisson Regression Model|||||0.003|-0.4741|0.054
71833518|NCT01553058|143171751|OTHER|Difference of differences||||||0.03|||||||Regression, Linear|||||||0.030
71738592|NCT01620528|142990197|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-1.21|-0.82|||ANOVA|||||-0.82|-1.21|< 0.001
71890160|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|-0.12||||0.8919|TWO_SIDED|95.0|-1.89|1.65|||ANCOVA|||Weight||1.65|-1.89|0.8919
71890161|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6653|TWO_SIDED|95.0|-2.25|1.44|||ANCOVA|||Weight||1.44|-2.25|0.6653
71738593|NCT01620528|142990198|SUPERIORITY||LS Mean of Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANOVA|||||-0.41|-0.81|< 0.001
71738594|NCT01620528|142990198|SUPERIORITY||LS Mean of Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.32|-0.92|||ANOVA|||||-0.92|-1.32|< 0.001
71738595|NCT01620528|142990199|SUPERIORITY||LS Mean of Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.83|-0.42|||ANOVA|||||-0.42|-0.83|< 0.001
71738596|NCT01620528|142990199|SUPERIORITY||LS Mean of Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|-1.47|-1.05|||ANOVA|||||-1.05|-1.47|< 0.001
71738597|NCT01620528|142990200|SUPERIORITY||LS Mean of Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.111|<|0.001|TWO_SIDED|95.0|-0.91|-0.48|||ANOVA|||||-0.48|-0.91|< 0.001
71738598|NCT01620528|142990200|SUPERIORITY||LS Mean of Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|-1.54|-1.1|||ANOVA|||||-1.10|-1.54|< 0.001
71738599|NCT01620528|142990201|SUPERIORITY||LS Mean of Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.96|-0.48|||ANOVA|||||-0.48|-0.96|< 0.001
71738600|NCT01620528|142990201|SUPERIORITY||LS Mean of Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.123|<|0.001|TWO_SIDED|95.0|-1.59|-1.11|||ANOVA|||||-1.11|-1.59|< 0.001
71738601|NCT01620528|142990202|SUPERIORITY||LS Mean of Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.109||0.011|TWO_SIDED|95.0|-0.52|-0.03|||mixed-effects model|||||-0.03|-0.52|0.011
71738602|NCT01620528|142990202|SUPERIORITY||LS Mean of Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|97.5|-0.65|-0.16|||mixed-effects model|||||-0.16|-0.65|< 0.001
71738603|NCT01620528|142990203|SUPERIORITY||LS Mean of Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.137|<|0.001|TWO_SIDED|97.5|-0.77|-0.16|||mixed-effects model|||||-0.16|-0.77|<0.001
71738604|NCT01620528|142990203|SUPERIORITY||LS Mean of Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.138||-0.96|TWO_SIDED|97.5|-1.27|-0.65|||mixed-effects model|||||-0.65|-1.27|-0.96
71738605|NCT01620528|142990204|SUPERIORITY||LS Mean of Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|97.5|-1.17|-0.44|||mixed-effects model|||||-0.44|-1.17|< 0.001
71738606|NCT01620528|142990204|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.165|<|0.001|TWO_SIDED|97.5|-1.98|-1.24|||mixed-effects model|||||-1.24|-1.98|< 0.001
71738607|NCT01620528|142990205|SUPERIORITY||LS Mean of Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.167|<|0.001|TWO_SIDED|97.5|-1.05|-0.3|||mixed-effects model|||||-0.30|-1.05|< 0.001
71738608|NCT01620528|142990205|SUPERIORITY||LS Mean of Difference|-1.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|97.5|-1.99|-1.23|||mixed-effects model|||||-1.23|-1.99|< 0.001
71738609|NCT01620528|142990206|SUPERIORITY||LS Mean of Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.176|<|0.001|TWO_SIDED|97.5|-1.04|-0.25|||mixed-effects model|||||-0.25|-1.04|< 0.001
71738610|NCT01620528|142990206|SUPERIORITY||LS Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|97.5|-2.0|-1.2|||mixed-effects model|||||-1.20|-2.00|< 0.001
71738611|NCT01620528|142990207|SUPERIORITY||Difference in LS Means|-6.29|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|-9.37|-3.21|||ANCOVA|||||-3.21|-9.37|< 0.001
71738612|NCT01620528|142990207|SUPERIORITY||Difference in LS Means|-9.76|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-12.91|-6.61|||ANCOVA|||||-6.61|-12.91|< 0.001
71738613|NCT01620528|142990208|SUPERIORITY||Difference in LS Means|-9.28|STANDARD_ERROR_OF_MEAN|1.72|<|0.001|TWO_SIDED|95.0|-12.66|-5.91|||ANCOVA|||||-5.91|-12.66|< 0.001
71738614|NCT01620528|142990208|SUPERIORITY||Difference in LS Means|-18.75|STANDARD_ERROR_OF_MEAN|1.77|<|0.001|TWO_SIDED|95.0|-22.22|-15.27|||ANCOVA|||||-15.27|-22.22|< 0.001
71738615|NCT01620528|142990209|SUPERIORITY||Difference in LS Means|-12.57|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-16.48|-8.66|||ANCOVA|||||-8.66|-16.48|< 0.001
71738616|NCT01620528|142990209|SUPERIORITY||Difference in LS Means|-25.1|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-29.12|-21.09|||ANCOVA|||||-21.09|-29.12|< 0.001
71738617|NCT01620528|142990210|SUPERIORITY||LS Mean of Difference|-0.78|STANDARD_ERROR_OF_MEAN|1.94||0.685|TWO_SIDED|95.0|-4.59|3.02|||ANCOVA|||||3.02|-4.59|0.685
71738618|NCT01620528|142990210|SUPERIORITY||Difference in LS Means|-5.04|STANDARD_ERROR_OF_MEAN|2.03||0.013|TWO_SIDED|95.0|-9.04|-1.05|||ANCOVA|||||-1.05|-9.04|0.013
71738619|NCT01620528|142990211|SUPERIORITY||Difference in LS Means|-4.74|STANDARD_ERROR_OF_MEAN|2.39||0.047|TWO_SIDED|95.0|-9.43|-0.05|||ANCOVA|||||-0.05|-9.43|0.047
71738620|NCT01620528|142990211|SUPERIORITY||Difference in LS Means|-13.86|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-18.89|-8.84|||ANCOVA|||||-8.84|-18.89|< 0.001
71738621|NCT01620528|142990212|SUPERIORITY||Difference in LS Means|-4.71|STANDARD_ERROR_OF_MEAN|2.91||0.107|TWO_SIDED|95.0|-10.43|1.02|||ANCOVA|||||1.02|-10.43|0.107
71738622|NCT01620528|142990212|SUPERIORITY||Difference in LS Means|-17.51|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-23.52|-11.5|||ANCOVA|||||-11.50|-23.52|< 0.001
71738623|NCT01620528|142990213|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.741|TWO_SIDED|95.0|-0.61|0.85|||ANCOVA|||||0.85|-0.61|0.741
71738624|NCT01620528|142990213|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.38||0.002|TWO_SIDED|95.0|-1.9|-0.42|||ANCOVA|||||-0.42|-1.90|0.002
71738625|NCT01620528|142990214|SUPERIORITY||Difference in LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.172|TWO_SIDED|95.0|-1.16|0.21|||ANCOVA|||||0.21|-1.16|0.172
71738626|NCT01620528|142990214|SUPERIORITY||Difference in LS Means|-1.27|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-1.97|-0.57|||ANCOVA|||||-0.57|-1.97|< 0.001
71738627|NCT01620528|142990215|SUPERIORITY||LS Mean of Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.43||0.016|TWO_SIDED|95.0|-1.9|-0.19|||ANCOVA|||||-0.19|-1.90|0.016
71738628|NCT01620528|142990215|SUPERIORITY||Difference in LS Means|-1.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-2.65|-0.91|||ANCOVA|||||-0.91|-2.65|< 0.001
71890162|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|2.35||||0.4213|TWO_SIDED|95.0|-3.43|8.14|||ANCOVA|||SBP||8.14|-3.43|0.4213
71890163|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|1.23||||0.6696|TWO_SIDED|95.0|-4.49|6.96|||ANCOVA|||SBP||6.96|-4.49|0.6696
71738629|NCT01620528|142990216|SUPERIORITY||Difference in LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.44||0.08|TWO_SIDED|95.0|-1.63|0.09|||ANCOVA|||||0.09|-1.63|0.080
71738630|NCT01620528|142990216|SUPERIORITY||Difference in LS Means|-1.37|STANDARD_ERROR_OF_MEAN|0.45||0.003|TWO_SIDED|95.0|-2.25|-0.48|||ANCOVA|||||-0.48|-2.25|0.003
71738631|NCT01620528|142990217|SUPERIORITY||Difference in LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.4||0.106|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||||0.14|-1.44|0.106
71774810|NCT01977937|143049823|OTHER|Differences in average pre-operative \& total post-operative average VAS scores were compared between groups using an unpaired Mann-Whitney rank sum test. Hospitalization outcomes including number of days to transition off PCA, number of days with Foley catheter, \& episodes of nausea, emesis, or POSS \> 3 were compared between groups using an unpaired two-tailed Student's t-test. Statistical significance was defined as p\<0.05 for all unpaired parametric and non-parametric comparisons.||||||0.07|||||||t-test, 2 sided|||D'Agostino \& Pearson normality test was used to assess for normal distribution. Experimental \& control groups were assessed for significant differences in age, hospital days, \& spinal levels fused using unpaired two-tailed Student's t-test. Differences in weight \& BMI were assessed using unpaired Mann-Whitney rank sum test. Differences in average VAS scores on the operative day, each post-operative day, and average total daily opioid were compared using an unpaired two-tailed Student's t-test.||||0.07
71774811|NCT01977937|143049824|OTHER|||||||0.02|||||||t-test, 2 sided|||Differences in the average total daily opioid were compared between groups using an unpaired two-tailed Student's t-test||||0.02
71774812|NCT05597020|143049835|SUPERIORITY||Least Square mean difference vs placebo|20.9||||0.002|TWO_SIDED|95.0|8.0|33.7|||Mixed Models Analysis|Treatment, period, week within period, and interaction of treatment and week were factors; baseline sTST assessment was covariate.||||33.7|8.0|0.002
71774813|NCT05169567|143049837|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.57|0.95|||Log Rank|||||0.95|0.57|0.02
71774814|NCT01015131|143049841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1521|||<|0.01|TWO_SIDED|90.0|0.0932|0.2111|||paired t-test|||||0.2111|0.0932|<0.01
71774815|NCT03029702|143049853|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
71738632|NCT01620528|142990217|SUPERIORITY||Difference in LS Means|-1.85|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.67|-1.02|||ANCOVA|||||-1.02|-2.67|< 0.001
71738633|NCT01620528|142990218|SUPERIORITY||Difference in LS Means|-0.75|STANDARD_ERROR_OF_MEAN|0.62||0.232|TWO_SIDED|95.0|-1.97|0.48|||ANCOVA|||||0.48|-1.97|0.232
71774816|NCT03029702|143049854|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
71774817|NCT03029702|143049855|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
71774818|NCT03029702|143049856|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
71738634|NCT01620528|142990218|SUPERIORITY||Difference in LS Means|-2.21|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-3.48|-0.93|||ANCOVA|||||-0.93|-3.48|< 0.001
71738635|NCT01620528|142990219|SUPERIORITY||Difference in LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.37||0.013|TWO_SIDED|95.0|-1.65|-0.2|||ANCOVA|||||-0.20|-1.65|0.013
71774819|NCT03029702|143049857|SUPERIORITY|||||||0.8|||||||Fisher Exact|||||||0.8
71774820|NCT03029702|143049858|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
71774821|NCT03029702|143049859|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
71774822|NCT03029702|143049860|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71738636|NCT01620528|142990219|SUPERIORITY||Difference in LS Means|-1.62|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.9|||ANCOVA|||||-0.90|-2.35|< 0.001
71774823|NCT05595382|143049888|SUPERIORITY|Repeated measures of likelihood to enroll (on a 1 to 7 scale with higher numbers indicating a greater likelihood) pre/post intervention||||||0.001|||||||ANOVA|Degrees of freedom (1, 359)||||||.001
71774824|NCT05595382|143049889|SUPERIORITY|||||||0.357|||||||ANOVA|Degrees of freedom (1, 358)||Repeated measures ANOVA comparing mood (rated on a 1-10 scale with higher scores indicating better mood) given to participants before and after the study manipulation by group||||.357
71774825|NCT05595382|143049890|SUPERIORITY|||||||0.102|||||||ANOVA|||||||.102
71774826|NCT02445391|143049899|NON_INFERIORITY|The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.62|1.81|||||The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.|||1.81|0.62|
71774827|NCT03722173|143049905|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|141.62|STANDARD_ERROR_OF_MEAN|13.3|||TWO_SIDED|90.0|129.64|154.71|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the geometric means (gMeans) (T/R) for AUC0-tz and their 2-sided 90% confidence intervals (CIs) were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||154.71|129.64|
71833519|NCT01553058|143171752|OTHER|Difference of differences||||||0.934|||||||Regression, Linear|||||||0.934
71833520|NCT01553058|143171752|OTHER|Difference of differences||||||0.679|||||||Regression, Linear|||||||0.679
71833521|NCT01553058|143171753|OTHER|Difference of differences||||||0.672|||||||Regression, Linear|||||||0.672
71833522|NCT01553058|143171753|OTHER|Difference of differences||||||0.655|||||||Regression, Linear|||||||0.655
71833523|NCT01553058|143171754|OTHER|Difference of differences||||||0.504|||||||Regression, Linear|||||||0.504
71738637|NCT01620528|142990220|SUPERIORITY||Difference in LS Means|-1.33|STANDARD_ERROR_OF_MEAN|0.47||0.005|TWO_SIDED|95.0|-2.24|-0.41|||ANCOVA|||||-0.41|-2.24|0.005
71738638|NCT01620528|142990220|SUPERIORITY||Difference in LS Means|-1.64|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-2.56|-0.71|||ANCOVA|||||-0.71|-2.56|< 0.001
71738639|NCT01620528|142990221|SUPERIORITY||Difference in LS Means|-1.63|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-2.53|-0.72|||ANCOVA|||||-0.72|-2.53|< 0.001
71738640|NCT01620528|142990221|SUPERIORITY||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.02|-1.19|||ANCOVA|||||-1.19|-3.02|< 0.001
71738641|NCT01620528|142990222|SUPERIORITY||Difference in LS Means|-1.21|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|-2.05|-0.38|||ANCOVA|||||-0.38|-2.05|0.004
71738642|NCT01620528|142990222|SUPERIORITY||Difference in LS Means|-2.23|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.06|-1.4|||ANCOVA|||||-1.40|-3.06|< 0.001
71890164|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|-1.23||||0.6819|TWO_SIDED|95.0|-7.2|4.73|||ANCOVA|||SBP||4.73|-7.20|0.6819
71890165|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|5.01||||0.1171|TWO_SIDED|95.0|-1.28|11.31|||ANCOVA|||DBP||11.31|-1.28|0.1171
71890166|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|3.94||||0.2155|TWO_SIDED|95.0|-2.33|10.21|||ANCOVA|||DBP||10.21|-2.33|0.2155
71890167|NCT03371355|143301963|SUPERIORITY||Least Squares Mean Difference|1.7||||0.6034|TWO_SIDED|95.0|-4.79|8.2|||ANCOVA|||DBP||8.20|-4.79|0.6034
71890168|NCT03371355|143301964|SUPERIORITY||Least Squares Mean Difference|0.98||||0.5752|TWO_SIDED|95.0|-2.48|4.44|||ANCOVA|||||4.44|-2.48|0.5752
71890169|NCT03371355|143301964|SUPERIORITY||Least Squares Mean Difference|4.09||||0.023|TWO_SIDED|95.0|0.58|7.59|||ANCOVA|||||7.59|0.58|0.0230
71890170|NCT03371355|143301964|SUPERIORITY||Least Squares Mean Difference|1.57||||0.3965|TWO_SIDED|95.0|-2.1|5.25|||ANCOVA|||||5.25|-2.10|0.3965
71890171|NCT03371355|143301965|SUPERIORITY||Least Squares Mean Difference|12.44||||0.3023|TWO_SIDED|95.0|-11.39|36.26|||ANCOVA|||||36.26|-11.39|0.3023
71890172|NCT03371355|143301965|SUPERIORITY||Least Squares Mean Difference|26.03||||0.035|TWO_SIDED|95.0|1.87|50.19|||ANCOVA|||||50.19|1.87|0.0350
71738643|NCT01620528|142990223|SUPERIORITY||Difference in LS Means|-0.97|STANDARD_ERROR_OF_MEAN|0.39||0.013|TWO_SIDED|95.0|-1.74|-0.2|||ANCOVA|||||-0.20|-1.74|0.013
71738644|NCT01620528|142990223|SUPERIORITY||Difference in LS Means|-1.81|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.58|-1.04|||ANCOVA|||||-1.04|-2.58|< 0.001
71738645|NCT01620528|142990224|SUPERIORITY||Difference in LS Means|-1.28|STANDARD_ERROR_OF_MEAN|0.48||0.007|TWO_SIDED|95.0|-2.22|-0.34|||ANCOVA|||||-0.34|-2.22|0.007
71738646|NCT01620528|142990224|SUPERIORITY||Difference in LS Means|-2.49|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.44|-1.54|||ANCOVA|||||-1.54|-3.44|< 0.001
71738647|NCT01620528|142990225|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.87||0.326|TWO_SIDED|95.0|-2.57|0.85|||ANCOVA|||||0.85|-2.57|0.326
71738648|NCT01620528|142990225|SUPERIORITY||Difference in LS Means|-1.93|STANDARD_ERROR_OF_MEAN|0.89||0.031|TWO_SIDED|95.0|-3.67|-0.18|||ANCOVA|||||-0.18|-3.67|0.031
71738649|NCT01620528|142990226|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.107|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||||0.31|-3.13|0.107
71738650|NCT01620528|142990226|SUPERIORITY||Difference in LS Means|-3.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.28|-1.75|||ANCOVA|||||-1.75|-5.28|< 0.001
71738651|NCT01620528|142990227|SUPERIORITY||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.82||0.219|TWO_SIDED|95.0|-2.63|0.6|||ANCOVA|||||0.60|-2.63|0.219
71738652|NCT01620528|142990227|SUPERIORITY||Difference in LS Means|-2.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-4.59|-1.28|||ANCOVA|||||-1.28|-4.59|< 0.001
71738653|NCT01620528|142990228|SUPERIORITY||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.72||0.026|TWO_SIDED|95.0|-3.01|-0.19|||ANCOVA|||||-0.19|-3.01|0.026
71738654|NCT01620528|142990228|SUPERIORITY||Difference in LS Means|-3.89|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-5.34|-2.43|||ANCOVA|||||-2.43|-5.34|< 0.001
71738655|NCT01620528|142990229|SUPERIORITY||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.76||0.502|TWO_SIDED|95.0|-2.0|0.98|||ANCOVA|||||0.98|-2.00|0.502
71774828|NCT03722173|143049906|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|113.32|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|102.47|125.32|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for Cmax and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||125.32|102.47|
71775100|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.82|TWO_SIDED|95.0|-1.32|0.55||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.55|-1.32|0.82
71890173|NCT03371355|143301965|SUPERIORITY||Least Squares Mean Difference|12.27||||0.3374|TWO_SIDED|95.0|-13.02|37.55|||ANCOVA|||||37.55|-13.02|0.3374
71890174|NCT03371355|143301967|SUPERIORITY||Least Squares Mean Difference|-2.59||||0.4583|TWO_SIDED|95.0|-9.49|4.31|||ANCOVA|||||4.31|-9.49|0.4583
71890175|NCT03371355|143301967|SUPERIORITY||Least Squares Mean Difference|-5.71||||0.0943|TWO_SIDED|95.0|-12.43|1.0|||ANCOVA|||||1.00|-12.43|0.0943
71890176|NCT03371355|143301967|SUPERIORITY||Least Squares Mean Difference|-4.57||||0.1909|TWO_SIDED|95.0|-11.45|2.32|||ANCOVA|||||2.32|-11.45|0.1909
71738656|NCT01620528|142990229|SUPERIORITY||Difference in LS Means|-3.13|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-4.7|-1.56|||ANCOVA|||||-1.56|-4.70|< 0.001
71738657|NCT01620528|142990230|SUPERIORITY||Difference in LS Means|-1.36|STANDARD_ERROR_OF_MEAN|0.85||0.108|TWO_SIDED|95.0|-3.02|0.3|||ANCOVA|||||0.30|-3.02|0.108
71738658|NCT01620528|142990230|SUPERIORITY||Difference in LS Means|-4.47|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.19|-2.74|||ANCOVA|||||-2.74|-6.19|< 0.001
71738659|NCT01620528|142990231|SUPERIORITY||Difference in LS Means|-1.19|STANDARD_ERROR_OF_MEAN|0.36||0.001|TWO_SIDED|95.0|-1.9|-0.48|||ANCOVA|||||-0.48|-1.90|0.001
71890177|NCT03371355|143301968|SUPERIORITY||Least Squares Mean Difference|7.1||||0.1294|TWO_SIDED|95.0|-2.1|16.22|||ANCOVA|||ALT||16.22|-2.10|0.1294
71890178|NCT03371355|143301968|SUPERIORITY||Least Squares Mean Difference|14.8||||0.0012|TWO_SIDED|95.0|5.98|23.59|||ANCOVA|||ALT||23.59|5.98|0.0012
71738660|NCT01620528|142990231|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.004|TWO_SIDED|95.0|-1.76|-0.34|||ANCOVA|||||-0.34|-1.76|0.004
71738661|NCT01620528|142990232|SUPERIORITY||Difference in LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.045|TWO_SIDED|95.0|-1.49|-0.02|||mixed-effects model|||||-0.02|-1.49|0.045
71738662|NCT01620528|142990232|SUPERIORITY||Difference in LS Means|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|-1.81|-0.31|||ANCOVA|||||-0.31|-1.81|0.006
71738663|NCT01620528|142990233|SUPERIORITY||Difference in LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.33||0.103|TWO_SIDED|95.0|-1.19|0.11|||ANCOVA|||||0.11|-1.19|0.103
71738664|NCT01620528|142990233|SUPERIORITY||Difference in LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.34||0.003|TWO_SIDED|95.0|-1.64|-0.32|||ANCOVA|||||-0.32|-1.64|0.003
71774829|NCT03722173|143049907|OTHER|Since the main focus was on estimation and not testing, a formal hypothesis test and associated acceptance range was not specified; no hypothesis was tested.|gMeans ratio (T/R) %|142.54|STANDARD_ERROR_OF_MEAN|13.5|||TWO_SIDED|90.0|130.3|155.93|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects for 'subjects' and 'treatment' was used.|Standard error of the mean is actually an intra-individual coefficient variation (CV). Confidence intervals (CIs) were calculated based on the residual error from the ANOVA and quantiles from the t distribution.|Point estimates for the ratios of the gMeans (T/R) for AUC0-∞ and their 2-sided 90% CIs were provided. The difference between the expected means for log(T) - log(R) were estimated by the difference in the corresponding adjusted means (Least Squares Means).||155.93|130.30|
71774830|NCT06624449|143049908|SUPERIORITY||Mean Difference (Final Values)|0.09|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
71774831|NCT00518687|143049994|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|18.5||||0.584|TWO_SIDED|95.0|-48.6|55.8||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significantly greater than 20%|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||55.8|-48.6|0.584
71774832|NCT00518687|143049995|SUPERIORITY_OR_OTHER||Estimated rate difference|0.0||||0.997|TWO_SIDED|95.0|-0.1|0.1|||Miettinen and Nurminen|||||0.1|-0.1|0.997
71774833|NCT00518687|143049996|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|12.9||||0.347|TWO_SIDED|95.0|-50.8|50.0||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||50.0|-50.8|0.347
71833524|NCT01553058|143171754|OTHER|Difference of differences||||||0.695|||||||Regression, Linear|||||||0.695
71833525|NCT01553058|143171755|OTHER|Difference of differences||||||0.002|||||||Regression, Linear|||||||0.002
71890179|NCT03371355|143301968|SUPERIORITY||Least Squares Mean Difference|8.9||||0.0594|TWO_SIDED|95.0|-0.36|18.11|||ANCOVA|||ALT||18.11|-0.36|0.0594
71890180|NCT03371355|143301968|SUPERIORITY||[Least Squares Mean Difference|5.0||||0.073|TWO_SIDED|95.0|-0.47|10.45|||ANCOVA|||AST||10.45|-0.47|0.0730
71738665|NCT01620528|142990234|SUPERIORITY||Difference in LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.36||0.39|TWO_SIDED|95.0|-1.01|0.4|||ANCOVA|||||0.40|-1.01|0.390
71738666|NCT01620528|142990234|SUPERIORITY||Difference in LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.36||0.003|TWO_SIDED|95.0|-1.75|-0.35|||ANCOVA|||||-0.35|-1.75|0.003
71774834|NCT00518687|143049997|SUPERIORITY_OR_OTHER||Vaccine Efficacy (VE)|29.3||||0.032|TWO_SIDED|95.0|-1.8|51.2||A 1-sided p-value \<0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo|||51.2|-1.8|0.032
71774835|NCT00704912|143050000|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.5||||0.06|TWO_SIDED|95.0|1.0|6.6|||Log-binomial model|||||6.6|1.0|0.06
71774836|NCT00704912|143050000|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3||||0.08|TWO_SIDED|95.0|0.9|6.1|||Log-binomial model|||||6.1|0.9|0.08
71774837|NCT00704912|143050000|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.82|TWO_SIDED|95.0|0.5|2.1|||Log-binomial model|||||2.1|0.5|0.82
71774838|NCT00704912|143050001|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.06|TWO_SIDED|95.0|1.0|1.7|||Log-binomial model|||||1.7|1.0|0.06
71833526|NCT01553058|143171755|OTHER|Difference of differences||||||0.009|||||||Regression, Linear|||||||0.009
71833527|NCT01553058|143171756|OTHER|Difference of Differences|||||<|0.001|||||||Regression, Linear|||||||<0.001
71833528|NCT01553058|143171756|OTHER|Difference of differences||||||0.065|||||||Regression, Linear|||||||0.065
71833529|NCT01553058|143171757|OTHER|Difference of differences||||||0.007|||||||Regression, Linear|||||||0.007
71833530|NCT01553058|143171757|OTHER|Difference of differences||||||0.019|||||||Regression, Linear|||||||0.019
71833531|NCT01553058|143171758|OTHER|Difference of differences||||||0.006|||||||Regression, Linear|||||||0.006
71833532|NCT01553058|143171758|OTHER|Difference of differences||||||0.628|||||||Regression, Linear|||||||0.628
71833533|NCT04992390|143171798|SUPERIORITY|Poisson regression was performed with baseline measure and binary arm status included as fixed effect covariates. Various regression models for count data were compared to find the best fitting model. Visual exploratory data and model evaluation showed that the Zero Inflated Negative Binomial (ZINB) regression model provided the best fit and was used as the model for the ITT analysis of the primary outcome.|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.2|0.48||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|||For more information on analysis models see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|See also Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.48|0.20|<= 0.001
71890181|NCT03371355|143301968|SUPERIORITY||Least Squares Mean Difference|8.4||||0.002|TWO_SIDED|95.0|3.17|13.7|||ANCOVA|||AST||13.70|3.17|0.0020
71738667|NCT01620528|142990235|SUPERIORITY||Difference in LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.46|TWO_SIDED|95.0|-0.72|0.32|||ANCOVA|||||0.32|-0.72|0.460
71738668|NCT01620528|142990235|SUPERIORITY||Difference in LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.52|||ANCOVA|||||-0.52|-1.57|< 0.001
71738669|NCT01620528|142990236|SUPERIORITY||LS Mean of Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.35||0.095|TWO_SIDED|95.0|-1.28|0.1|||ANCOVA|||||0.10|-1.28|0.095
71738670|NCT01620528|142990236|SUPERIORITY||Difference in LS Means|-1.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.01|-0.59|||ANCOVA|||||-0.59|-2.01|< 0.001
71738671|NCT01620528|142990237|SUPERIORITY||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.97||0.462|TWO_SIDED|95.0|-2.61|1.19|||ANCOVA|||||1.19|-2.61|0.462
71833534|NCT04992390|143171799|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the delayed intervention arm, comparing pre-intervention (week 4) to post-intervention (week 8).|Incidence Rate Ratio|0.31|||<=|0.001|TWO_SIDED|95.0|0.21|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the comparator arm, where participants had delayed access to the intervention (i.e., delayed arm crossover), the number of intrusive memories in week 8 was compared to week 4. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|For full results see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|0.45|0.21|<= 0.001
71833535|NCT04992390|143171799|SUPERIORITY|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories in the immediate intervention arm, comparing pre-intervention (run-in/screening week) to post-intervention (week 4).|Incidence Rate Ratio|0.22|||<|0.001|TWO_SIDED|95.0|0.1|0.45||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Poisson|Single level general Poisson regression was used to quantify within arm changes of number of intrusive memories pre- to post-intervention.||Within the immediate intervention arm, where participants had immediate access to the intervention, the number of intrusive memories in Week 4 was compared to the run-in/screening week. For full information about statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0||0.45|0.10|<0.001
71890182|NCT03371355|143301968|SUPERIORITY||Least Squares Mean Difference|6.5||||0.02|TWO_SIDED|95.0|1.05|12.0|||ANCOVA|||AST||12.00|1.05|0.0200
71890183|NCT03371355|143301969|SUPERIORITY||Least Squares Mean Difference|-1.19||||0.4812|TWO_SIDED|95.0|-4.55|2.16|||ANCOVA|||||2.16|-4.55|0.4812
71890184|NCT03371355|143301969|SUPERIORITY||Least Squares Mean Difference|-1.53||||0.3679|TWO_SIDED|95.0|-4.88|1.83|||ANCOVA|||||1.83|-4.88|0.3679
71890185|NCT03371355|143301969|SUPERIORITY||Least Squares Mean Difference|-4.18||||0.021|TWO_SIDED|95.0|-7.72|-0.65|||ANCOVA|||||-0.65|-7.72|0.0210
71890186|NCT03371355|143301970|SUPERIORITY||Least Squares Mean Difference|-0.15||||0.6227|TWO_SIDED|95.0|-0.73|0.44|||ANCOVA|||||0.44|-0.73|0.6227
71890187|NCT03371355|143301970|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.195|TWO_SIDED|95.0|-0.97|0.2|||ANCOVA|||||0.20|-0.97|0.1950
71890188|NCT03371355|143301970|SUPERIORITY||Least Squares Mean Difference|-0.38||||0.2271|TWO_SIDED|95.0|-1.0|0.24|||ANCOVA|||||0.24|-1.00|0.2271
71890189|NCT03371355|143301971|SUPERIORITY||Least Squares Mean Difference|17.06||||0.8591|TWO_SIDED|95.0|-173.57|207.69|||ANCOVA|||SAT||207.69|-173.57|0.8591
71890190|NCT03371355|143301971|SUPERIORITY||Least Squares Mean Difference|32.92||||0.7404|TWO_SIDED|95.0|-164.11|229.95|||ANCOVA|||SAT||229.95|-164.11|0.7404
71890191|NCT03371355|143301971|SUPERIORITY||Least Squares Mean Difference|-16.3||||0.8711|TWO_SIDED|95.0|-215.5|182.9|||ANCOVA|||SAT||182.90|-215.50|0.8711
71890192|NCT03371355|143301971|SUPERIORITY||Least Squares Mean Difference|4.95||||0.9569|TWO_SIDED|95.0|-176.64|186.53|||ANCOVA|||VAT||186.53|-176.64|0.9569
71738672|NCT01620528|142990237|SUPERIORITY||Difference in LS Means|-3.23|STANDARD_ERROR_OF_MEAN|0.98||0.001|TWO_SIDED|95.0|-5.16|-1.3|||ANCOVA|||||-1.30|-5.16|0.001
71738673|NCT01620528|142990238|SUPERIORITY||Difference in LS Means|-2.02|STANDARD_ERROR_OF_MEAN|0.97||0.039|TWO_SIDED|95.0|-3.93|-0.11|||ANCOVA|||||-0.11|-3.93|0.039
71738674|NCT01620528|142990238|SUPERIORITY||Difference in LS Means|-4.86|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-6.82|-2.9|||ANCOVA|||||-2.90|-6.82|< 0.001
71738675|NCT01620528|142990239|SUPERIORITY||Difference in LS Means|-2.2|STANDARD_ERROR_OF_MEAN|1.03||0.032|TWO_SIDED|95.0|-4.21|-0.18|||ANCOVA|||||-0.18|-4.21|0.032
71738676|NCT01620528|142990239|SUPERIORITY||Difference in LS Means|-4.91|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-6.95|-2.86|||ANCOVA|||||-2.86|-6.95|< 0.001
71890193|NCT03371355|143301971|SUPERIORITY||Least Squares Mean Difference|-24.26||||0.8025|TWO_SIDED|95.0|-216.53|168.02|||ANCOVA|||VAT||168.02|-216.53|0.8025
71738677|NCT01620528|142990240|SUPERIORITY||Difference in LS Means|-2.42|STANDARD_ERROR_OF_MEAN|0.94||0.01|TWO_SIDED|95.0|-4.26|-0.58|||ANCOVA|||||-0.58|-4.26|0.010
71738678|NCT01620528|142990240|SUPERIORITY||Difference in LS Means|-5.25|STANDARD_ERROR_OF_MEAN|0.96|<|0.001|TWO_SIDED|95.0|-7.14|-3.36|||ANCOVA|||||-3.36|-7.14|< 0.001
71738679|NCT01620528|142990241|SUPERIORITY||Difference in LS Means|-1.17|STANDARD_ERROR_OF_MEAN|0.94||0.215|TWO_SIDED|95.0|-3.02|0.68|||ANCOVA|||||0.68|-3.02|0.215
71738680|NCT01620528|142990241|SUPERIORITY||Difference in LS Means|-5.13|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-7.06|-3.2|||ANCOVA|||||-3.20|-7.06|< 0.001
71738681|NCT01620528|142990242|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|1.16||0.053|TWO_SIDED|95.0|-4.53|0.03|||ANCOVA|||||0.03|-4.53|0.053
71738682|NCT01620528|142990242|SUPERIORITY||Difference in LS Means|-6.79|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.17|-4.41|||ANCOVA|||||-4.41|-9.17|< 0.001
71738683|NCT01620528|142990243|SUPERIORITY||Difference in LS Means|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.24|-1.01|||ANCOVA|||||-1.01|-3.24|< 0.001
71738684|NCT01620528|142990243|SUPERIORITY||Difference in LS Means|-2.6|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.71|-1.49|||ANCOVA|||||-1.49|-3.71|< 0.001
71738685|NCT01620528|142990244|SUPERIORITY||Difference in LS Means|-2.09|STANDARD_ERROR_OF_MEAN|0.67||0.002|TWO_SIDED|95.0|-3.4|-0.78|||ANCOVA|||||-0.78|-3.40|0.002
71738686|NCT01620528|142990244|SUPERIORITY||Difference in LS Means|-2.65|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|-3.98|-1.32|||ANCOVA|||||-1.32|-3.98|< 0.001
71738687|NCT01620528|142990245|SUPERIORITY||Difference in LS Means|-2.17|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|-3.39|-0.95|||ANCOVA|||||-0.95|-3.39|< 0.001
71738688|NCT01620528|142990245|SUPERIORITY||Difference in LS Means|-3.0|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.23|-1.76|||ANCOVA|||||-1.76|-4.23|< 0.001
71890194|NCT03371355|143301971|SUPERIORITY||Least Squares Mean Difference|22.02||||0.8202|TWO_SIDED|95.0|-170.09|214.12|||ANCOVA|||VAT||214.12|-170.09|0.8202
71890195|NCT03371355|143301972|SUPERIORITY||Least Squares Mean Difference|0.11||||0.9734|TWO_SIDED|95.0|-6.47|6.69|||ANCOVA|||||6.69|-6.47|0.9734
71890196|NCT03371355|143301972|SUPERIORITY||Least Squares Mean Difference|-0.7||||0.8333|TWO_SIDED|95.0|-7.25|5.86|||ANCOVA|||||5.86|-7.25|0.8333
71774839|NCT00704912|143050001|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.002|TWO_SIDED|95.0|1.1|1.9|||Log-binomial model|||||1.9|1.1|0.002
71660793|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.639||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 18||||0.639
71890197|NCT03371355|143301972|SUPERIORITY||Least Squares Mean Difference|1.66||||0.6207|TWO_SIDED|95.0|-4.99|8.31|||ANCOVA|||||8.31|-4.99|0.6207
71660794|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.325||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.325
71660795|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.108||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.108
71660796|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.078||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 24||||0.078
71660797|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.106||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.106
71660798|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.236||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.236
71660799|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.164||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||0.164
71660800|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.031||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.031
71738689|NCT01620528|142990246|SUPERIORITY||Difference in LS Means|-1.54|STANDARD_ERROR_OF_MEAN|0.64||0.017|TWO_SIDED|95.0|-2.8|-0.27|||ANCOVA|||||-0.27|-2.80|0.017
71738690|NCT01620528|142990246|SUPERIORITY||Difference in LS Means|-3.24|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.5|-1.98|||ANCOVA|||||-1.98|-4.50|< 0.001
71738691|NCT01620528|142990247|SUPERIORITY||Difference in LS Means|-1.14|STANDARD_ERROR_OF_MEAN|0.55||0.038|TWO_SIDED|95.0|-2.22|-0.07|||ANCOVA|||||-0.07|-2.22|0.038
71738692|NCT01620528|142990247|SUPERIORITY||Difference in LS Means|-2.83|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.91|-1.74|||ANCOVA|||||-1.74|-3.91|< 0.001
71738693|NCT01620528|142990248|SUPERIORITY||Difference in LS Means|-1.83|STANDARD_ERROR_OF_MEAN|0.66||0.006|TWO_SIDED|95.0|-3.13|-0.54|||ANCOVA|||||-0.54|-3.13|0.006
71660801|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.224||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.224
71660802|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.291||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||0.291
71660803|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.324||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.324
71660804|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.188||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.188
71660805|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.503||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 18||||0.503
71660806|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.385||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.385
71660807|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.727||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.727
71660808|NCT03118570|142835389|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.338||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 24||||0.338
71738694|NCT01620528|142990248|SUPERIORITY||Difference in LS Means|-3.75|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-5.06|-2.44|||ANCOVA|||||-2.44|-5.06|< 0.001
71738695|NCT03824587|142990253|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|99.0|-1.13|-0.18|||Mixed Models Analysis|||||-0.18|-1.13|0.0004
71738696|NCT03824587|142990254|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0097|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0097
71738697|NCT03824587|142990255|SUPERIORITY|||||||0.0027|||||||ANOVA|||||||0.0027
71738698|NCT03824587|142990256|SUPERIORITY|||||||0.0011|||||||ANOVA|||||||0.0011
71660809|NCT03118570|142835390|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 6||||< 0.001
71660810|NCT03118570|142835390|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Radial, Month 12||||< 0.001
71660811|NCT03118570|142835390|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 6||||< 0.001
71660812|NCT03118570|142835390|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Tibial, Month 12||||< 0.001
71660813|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71738699|NCT00986362|142990257|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.613||||0.679|TWO_SIDED|95.0|0.07|4.509|||Fisher Exact|||||4.509|0.070|0.679
71738700|NCT01007838|142990278|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was accepted if p \< 0.05.|ANCOVA|||Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controls||||0.30
71738701|NCT01007838|142990278|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Statistical significance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.0017
71738702|NCT01007838|142990278|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||Statistical sigficance was accepted if p \< 0.05.|ANOVA|||Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.||||0.024
71738703|NCT04167137|142990280|OTHER|||||||||||||||||Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|Because only 1 participant experienced a DLT (Grade 3 cytokine release syndrome in Arm 1 Cohort 6), no MTD could be reached.|||
71738704|NCT00997594|142990287|NON_INFERIORITY_OR_EQUIVALENCE|Just a comparison of the percentage of hypertension between the 2 patient groups.|||||<|0.05||95.0|||||Chi-squared, Corrected|||||||<0.05
71738705|NCT02611817|142990288|SUPERIORITY||Clopper-Pearson method|13.7||||0.008|TWO_SIDED|95.0|3.8|23.7|||Cochran-Mantel-Haenszel|||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by electronic data capture (EDC) stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||23.7|3.8|0.008
71738706|NCT02611817|142990289|SUPERIORITY||Clopper-Pearson method|7.3||||0.167|TWO_SIDED|95.0|-3.0|17.5|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||17.5|-3.0|0.167
71738707|NCT02611817|142990290|SUPERIORITY||Clopper-Pearson method|27.1||||0.002|TWO_SIDED|95.0|11.9|42.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||42.3|11.9|0.002
71738708|NCT02611817|142990291|SUPERIORITY||Clopper-Pearson method|4.3||||0.591|TWO_SIDED|95.0|-11.6|20.3|||Cochran-Mantel-Haenszel|||P-value was calculated by CMH test stratified by EDC stratum according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-alpha antagonist failure/exposed or concomitant immunomodulator use.||20.3|-11.6|0.591
71738709|NCT02170870|142990292|SUPERIORITY|||||||0.06|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs diabetics adjusted for treatment status (ie, exendin or placebo)||||0.06
71738710|NCT02170870|142990292|SUPERIORITY|||||||0.0001|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs functional dyspepsia adjusted for treatment status (ie, exendin or placebo)||||0.0001
71774840|NCT00704912|143050001|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.28|TWO_SIDED|95.0|0.7|1.1|||Log-binomial model|||||1.1|0.7|0.28
71774841|NCT00704912|143050002|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.3|-3.8|||Mixed Models Analysis||Lifestyle vs. OCP|||-3.8|-6.3|<.0001
71660814|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71660815|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.08||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.080
71660816|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
71660817|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.238||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.238
71660818|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.035||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.035
71890198|NCT03371355|143301973|SUPERIORITY||Least Squares Mean Difference|0.01||||0.8026|TWO_SIDED|95.0|-0.04|0.06|||ANCOVA|||||0.06|-0.04|0.8026
71890199|NCT03371355|143301973|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.4917|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA|||||0.03|-0.07|0.4917
71890200|NCT03371355|143301973|SUPERIORITY||Least Squares Mean Difference|0.0||||0.8916|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||||0.05|-0.05|0.8916
71660819|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.687||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.687
71660820|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.107||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.107
71660821|NCT03118570|142835392|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.128||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.128
71660822|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71660823|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71660824|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.088||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.088
71660825|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.184||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.184
71660826|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.144||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.144
71660827|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.028||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.028
71774842|NCT00704912|143050002|SUPERIORITY_OR_OTHER||Difference in Mean Change|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.7|||Mixed Models Analysis||Combined vs. OCP|||-3.7|-6.2|<.0001
71890201|NCT03371355|143301974|SUPERIORITY||Least Squares Mean Difference|0.11||||0.728|TWO_SIDED|95.0|-0.5|0.71|||ANCOVA|||||0.71|-0.50|0.7280
71890202|NCT03371355|143301974|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.7354|TWO_SIDED|95.0|-0.69|0.49|||ANCOVA|||||0.49|-0.69|0.7354
71890203|NCT03371355|143301974|SUPERIORITY||Least Squares Mean Difference|-0.23||||0.4682|TWO_SIDED|95.0|-0.84|0.39|||ANCOVA|||||0.39|-0.84|0.4682
71890317|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|3.174||0.1645|TWO_SIDED|95.0|-10.66|1.82|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.82|-10.66|0.1645
71660828|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.694||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.694
71660829|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.143||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.143
71660830|NCT03118570|142835393|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.111||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.111
71660831|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71660832|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline|||||<|0.001||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||< 0.001
71660833|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.026||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Lumbar||||0.026
71660834|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.007||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.007
71660835|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.004||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.004
71774843|NCT00704912|143050002|SUPERIORITY_OR_OTHER||Difference in Mean Change|-0.1||||0.92|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis||Lifestyle vs. Combined|||1.2|-1.3|0.92
71890318|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.158||0.124|TWO_SIDED|95.0|-11.07|1.34|||Mixed Models Analysis|||Activity Impairment Change from Baseline||1.34|-11.07|0.1240
71833536|NCT04992390|143171800|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.63|||<=|0.001|TWO_SIDED|95.0|-3.72|-1.54||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How distressing were your intrusive memories?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.54|-3.72|<= 0.001
71833537|NCT04992390|143171800|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-3.21|||<=|0.001|TWO_SIDED|95.0|-4.28|-2.15||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they disrupt your concentration?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-2.15|-4.28|<= 0.001
71890204|NCT00125034|143301995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.516||||0.064|TWO_SIDED|95.0|0.975|2.335|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 \& 50% under FOLFOX-4 alone for the stratum with ECOG PS0-1 \& 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%||2.335|0.975|0.064
71890205|NCT00125034|143301996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.551||||0.0027|TWO_SIDED|95.0|1.38|4.717|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||4.717|1.380|0.0027
71738711|NCT02391363|142990299|SUPERIORITY|||||||0.77||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05."||||0.77
71774844|NCT00704912|143050003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.6|TWO_SIDED|95.0|0.6|2.2|||GEE||End of intervention compared to baseline.|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||2.2|0.6|0.60
71833538|NCT04992390|143171800|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.92|||<=|0.001|TWO_SIDED|95.0|-3.9|-1.95||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did they interfere with what you were doing?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.95|-3.90|<= 0.001
71890206|NCT00125034|143301997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.459||||0.029|TWO_SIDED|95.0|0.228|0.924|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||||0.924|0.228|0.0290
71774845|NCT00704912|143050003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.001|TWO_SIDED|95.0|1.4|4.3|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||4.3|1.4|0.001
71890207|NCT00125034|143301998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.931||||0.617|TWO_SIDED|95.0|0.705|1.23|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.230|0.705|0.6170
71890208|NCT00125034|143301999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.567||||0.0064|TWO_SIDED|95.0|0.375|0.856|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.856|0.375|0.0064
71774846|NCT00704912|143050003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.18|TWO_SIDED|95.0|0.4|1.2|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.||1.2|0.4|0.18
71774847|NCT00704912|143050003|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||GEE|||||||0.08
71774848|NCT00704912|143050003|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE|||||||0.001
71774849|NCT00704912|143050003|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||GEE|||||||0.22
71738712|NCT02391363|142990300|SUPERIORITY|||||||0.07||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.07
71738713|NCT02391363|142990301|SUPERIORITY|||||||0.34||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.34
71738714|NCT02391363|142990302|SUPERIORITY|||||||0.08||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.08
71738715|NCT02391363|142990303|SUPERIORITY|||||||0.45||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.45
71738716|NCT02391363|142990304|SUPERIORITY|||||||0.13||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.13
71738717|NCT02391363|142990305|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
71738718|NCT02391363|142990306|SUPERIORITY|||||||0.29||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.29
71738719|NCT02391363|142990307|SUPERIORITY|||||||0.14||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.14
71774850|NCT02349061|143050015|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0057|TWO_SIDED|95.0|1.41|7.63|||Regression, Logistic|||||7.63|1.41|0.0057
71774851|NCT02349061|143050016|SUPERIORITY||Least Squares (LS) Mean Difference|-1.36||||0.0929|TWO_SIDED|95.0|-2.94|0.23|||Mixed model repeated measures model|||||0.23|-2.94|0.0929
71774852|NCT02349061|143050017|SUPERIORITY||LS Means Difference|-0.383||||0.3944|TWO_SIDED|95.0|-1.271|0.506|||Mixed model repeated measures model|||||0.506|-1.271|0.3944
71774853|NCT02349061|143050018|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9939|TWO_SIDED|95.0|0.43|2.34|||Regression, Logistic|||||2.34|0.43|0.9939
71774854|NCT02349061|143050019|SUPERIORITY||LS Means Difference|-2.17||||0.1032|TWO_SIDED|95.0|-4.78|0.45|||Mixed model repeated measures model|||||0.45|-4.78|0.1032
71774855|NCT02339285|143050037|OTHER|F-test; Treatment effect|||||>|0.1|||||||ANOVA|F(2, 29)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||>0.10
71774856|NCT02339285|143050037|OTHER|F-test; Session effect|||||<|0.001|||||||ANOVA|F(1, 31)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."||||<0.001
71774857|NCT02339285|143050037|OTHER|F-test; Interaction effect (session x treatment)|||||>|0.1|||||||ANOVA|F(2,29)||||||>0.10
71890209|NCT00125034|143302000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.72||||0.0153|TWO_SIDED|95.0|1.104|2.679|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||2.679|1.104|0.0153
71774858|NCT02339285|143050038|OTHER|F-test; Condition effect|||||<|0.05|||||||ANOVA|F(2,21.595)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.05
71890319|NCT03952559|143302136|SUPERIORITY||LS Mean difference (Final Values)|-7.02|STANDARD_ERROR_OF_MEAN|3.163||0.027|TWO_SIDED|95.0|-13.23|-0.8|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-0.80|-13.23|0.0270
71660836|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.085||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Total body||||0.085
71660837|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.04||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.040
71738720|NCT02391363|142990308|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
71738721|NCT02391363|142990309|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
71738722|NCT02391363|142990310|SUPERIORITY|||||||0.35||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.35
71738723|NCT02391363|142990311|SUPERIORITY|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.52
71738724|NCT02391363|142990312|SUPERIORITY|||||||0.92||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.92
71738725|NCT02391363|142990313|SUPERIORITY|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.59
71738726|NCT02391363|142990314|SUPERIORITY|||||||0.89||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.89
71738727|NCT02391363|142990315|SUPERIORITY|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.64
71738728|NCT02391363|142990316|SUPERIORITY|||||||0.94||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.94
71774859|NCT02339285|143050038|OTHER|F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal)|||||<|0.001|||||||ANOVA|F(3, 79.358)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||<0.001
71738729|NCT02391363|142990317|SUPERIORITY|||||||0.98||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.98
71738730|NCT02391363|142990318|SUPERIORITY|||||||0.88||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.88
71738731|NCT02391363|142990319|SUPERIORITY|||||||0.31||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.31
71738732|NCT02391363|142990320|SUPERIORITY|||||||0.96||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.96
71774860|NCT02339285|143050038|OTHER|F-test; Interaction effect (region x condition)|||||>|0.1|||||||ANOVA|F(6, 68.284)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."||||>0.10
71774861|NCT02339285|143050039|OTHER||||||>|0.1|||||||ANOVA|||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups."||||>0.10
71774862|NCT00537238|143050056|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the difference in proportion (Pregabalin - Levetiracetam) was greater than -0.12.|Difference in Proportion|0.0|||||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
71774863|NCT00537238|143050057|SUPERIORITY_OR_OTHER_LEGACY||Median difference|4.1||||0.3571|TWO_SIDED|95.0|-2.6|10.9|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||10.9|-2.6|0.3571
71774864|NCT00537238|143050059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|TWO_SIDED||||||Fisher Exact|||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0822
71774865|NCT00537238|143050059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9175|TWO_SIDED||||||Fisher Exact|||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.9175
71774866|NCT00537238|143050059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0483|TWO_SIDED||||||Fisher Exact|||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.0483
71774867|NCT00537238|143050059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7139|TWO_SIDED||||||Fisher Exact|||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.||||0.7139
71774868|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.78||0.1334|TWO_SIDED|95.0|-0.36|2.69|||ANCOVA|||Baseline, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||2.69|-0.36|0.1334
71774869|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3551|TWO_SIDED|95.0|-0.19|0.52|||ANCOVA|||Baseline, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.52|-0.19|0.3551
71774870|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.46|STANDARD_ERROR_OF_MEAN|0.5||0.3638|TWO_SIDED|95.0|-1.45|0.53|||ANCOVA|||Change at Week 7, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.53|-1.45|0.3638
71774871|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.2457|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||Change at Week 7, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.34|0.2457
71890320|NCT03952559|143302137|SUPERIORITY||LS Mean difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|2.778||0.4778|TWO_SIDED|95.0|-3.49|7.43|||Mixed Models Analysis|||||7.43|-3.49|0.4778
71660838|NCT03118570|142835394|SUPERIORITY|Comparison is between the Visit and Baseline||||||0.061||||||Analysis is based on an ANCOVA model with Change from Baseline as outcome parameter; including categorical effects of treatment and randomization stratum as well as the associated baseline value as a covariate.|ANCOVA|||Femoral neck||||0.061
71738733|NCT02391363|142990321|SUPERIORITY|"We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||||0.52||||||Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||||||0.52
71738734|NCT02391363|142990322|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
71738735|NCT02391363|142990323|SUPERIORITY|||||||0.04||||||Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.04
71738736|NCT02391363|142990324|SUPERIORITY|||||||0.001||||||Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.001
71738737|NCT02391363|142990325|SUPERIORITY|||||||0.42||||||Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.42
71738738|NCT02391363|142990326|SUPERIORITY|||||||0.85||||||Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.85
71738739|NCT02391363|142990327|SUPERIORITY|||||||0.55||||||Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.55
71774872|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.23|STANDARD_ERROR_OF_MEAN|0.53||0.664|TWO_SIDED|95.0|-1.26|0.81|||ANCOVA|||Change at Week 10, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.81|-1.26|0.6640
71738740|NCT02391363|142990328|SUPERIORITY|||||||0.54||||||Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||0.54
71738741|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.14|||||TWO_SIDED|95.0|0.95|1.37||||||Serotype 1: Geometric mean ratios (GMRs) (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% confidence intervals (CIs).||1.37|0.95|
71738742|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.88|1.16||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.88|
71738743|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.78|
71738744|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.77|
71738745|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|1.03|1.5||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.50|1.03|
71738746|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.21||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.85|
71738747|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.82|1.17||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.17|0.82|
71774873|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.595|TWO_SIDED|95.0|-0.3|0.17|||ANCOVA|||Change at Week 10, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.17|-0.30|0.5950
71774874|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.31|STANDARD_ERROR_OF_MEAN|0.55||0.5701|TWO_SIDED|95.0|-1.38|0.76|||ANCOVA|||Change at Week 13, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.76|-1.38|0.5701
71774875|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2452|TWO_SIDED|95.0|-0.33|0.08|||ANCOVA|||Change at Week 13, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.08|-0.33|0.2452
71774876|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.77|STANDARD_ERROR_OF_MEAN|0.56||0.1697|TWO_SIDED|95.0|-1.88|0.33|||ANCOVA|||Change at Week 16, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.33|-1.88|0.1697
71774877|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.2283|TWO_SIDED|95.0|-0.36|0.09|||ANCOVA|||Change at Week 16, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.09|-0.36|0.2283
71774878|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-1.35|STANDARD_ERROR_OF_MEAN|0.61||0.0262|TWO_SIDED|95.0|-2.54|-0.16|||ANCOVA|||Change at Follow-up, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||-0.16|-2.54|0.0262
71774879|NCT00537238|143050060|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.26|STANDARD_ERROR_OF_MEAN|0.13||0.0495|TWO_SIDED|95.0|-0.52|0.0|||ANCOVA|||Change at Follow-up, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.00|-0.52|0.0495
71738748|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.93|
71738749|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.9|1.27||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.27|0.90|
71774880|NCT00537238|143050061|SUPERIORITY_OR_OTHER_LEGACY||LS mean differences|-0.09|STANDARD_ERROR_OF_MEAN|0.37||0.8084|TWO_SIDED|95.0|-0.82|0.64|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.64|-0.82|0.8084
71890321|NCT03952559|143302137|SUPERIORITY||LS Mean difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.743||0.4649|TWO_SIDED|95.0|-3.38|7.39|||Mixed Models Analysis|||||7.39|-3.38|0.4649
71890210|NCT00125034|143302001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015||||0.905|TWO_SIDED|95.0|0.791|1.303|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.303|0.791|0.9050
71890211|NCT00125034|143302002|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3854|TWO_SIDED|95.0|0.599|1.219|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.219|0.599|0.3854
71738750|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.07|0.72|
71738751|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.12|0.81|
71738752|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.21|0.81|
71738753|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.72|1.16||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.16|0.72|
71738754|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.19|||||TWO_SIDED|95.0|1.0|1.4||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.40|1.00|
71738755|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.36|0.91|
71738756|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.29|||||TWO_SIDED|95.0|1.03|1.6||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.60|1.03|
71738757|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.33||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.33|0.88|
71738758|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.91|1.46||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.46|0.91|
71738759|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.87|1.43||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.43|0.87|
71738760|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.83|1.3||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 2) and 2-sided 95% CIs.||1.30|0.83|
71738761|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.21|||||TWO_SIDED|95.0|1.01|1.46||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.46|1.01|
71738762|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.96|
71738763|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.22||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.22|0.82|
71738764|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.31|0.89|
71738765|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.69|1.16|
71738766|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.94|1.35||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.35|0.94|
71890212|NCT00125034|143302003|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2004|TWO_SIDED|95.0|0.873|1.906|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.906|0.873|0.2004
71890213|NCT03529409|143302016|SUPERIORITY||Mean Difference (Net)|-0.287||||0.01|TWO_SIDED|95.0|-0.507|-0.066|||Mixed Models Analysis|||||-.066|-.507|.01
71890214|NCT03529409|143302017|SUPERIORITY||Mean Difference (Net)|1.95||||0.28|TWO_SIDED|95.0|-1.61|5.5||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||5.50|-1.61|.28
71738767|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.97|||||TWO_SIDED|95.0|0.81|1.16||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.81|
71738768|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.87|
71738769|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.94|
71738770|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.13||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.13|0.75|
71738771|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.20|0.86|
71738772|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
71738773|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.25|0.78|
71738774|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.16|0.83|
71890215|NCT03529409|143302018|SUPERIORITY||Mean Difference (Net)|157.0||||0.16|TWO_SIDED|95.0|-67.0|382.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||382|-67|.16
71738775|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.87|1.3||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.30|0.87|
71738776|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.24|0.80|
71738777|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.94|1.42||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.42|0.94|
71738778|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.33||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.33|0.82|
71738779|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.98|||||TWO_SIDED|95.0|0.77|1.26||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.26|0.77|
71738780|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.82|1.29||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 1 to Lot 3) and 2-sided 95% CIs.||1.29|0.82|
71738781|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.28||||||Serotype 1: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.28|0.89|
71738782|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.24||||||Serotype 3: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.95|
71738783|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.85|1.27||||||Serotype 4: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.27|0.85|
71738784|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.16|||||TWO_SIDED|95.0|0.96|1.41||||||Serotype 5: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.41|0.96|
71738785|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.93|1.36||||||Serotype 6A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.36|0.93|
71738786|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33||||||Serotype 6B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.33|0.93|
71738787|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.83|1.19||||||Serotype 7F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.19|0.83|
71890322|NCT03952559|143302137|SUPERIORITY||LS Mean difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.755||0.1013|TWO_SIDED|95.0|-0.89|9.94|||Mixed Models Analysis|||||9.94|-0.89|0.1013
71738788|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.12||||||Serotype 9V: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.78|
71890216|NCT03529409|143302019|SUPERIORITY||Mean Difference (Net)|0.25||||0.77|TWO_SIDED|95.0|-1.51|2.0||The overall omnibus test of the time by treatment interaction was p=.90. The estimate below is for post-treatment, comparing TAU to Khanya.|Mixed Models Analysis|||||2.00|-1.51|.77
71738789|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.24||||||Serotype 14: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.88|
71738790|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||Serotype 18C: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.29|0.86|
71738791|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||Serotype 19A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.25|0.91|
71738792|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.79|1.17||||||Serotype 19F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.79|
71738793|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.85|1.37||||||Serotype 23F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.37|0.85|
71738794|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 8: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.98|0.70|
71738795|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.17||||||Serotype 10A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.17|0.78|
71738796|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.96||||||Serotype 11A: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||0.96|0.62|
71738797|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.87|1.31||||||Serotype 12F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.31|0.87|
71738798|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 15B: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.15|0.71|
71738799|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.88|||||TWO_SIDED|95.0|0.69|1.12||||||Serotype 22F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.12|0.69|
71738800|NCT03828617|142990334|EQUIVALENCE|Lots were considered equivalent if each of the pairwise 2-sided 95% CIs for the GMRs of OPA titers was contained in the interval (0.5, 2.0).|Geometric Mean Ratio|0.99|||||TWO_SIDED|95.0|0.79|1.24||||||Serotype 33F: GMRs (ratio of GMTs for 20vPnC Lot 2 to Lot 3) and 2-sided 95% CIs.||1.24|0.79|
71738801|NCT02510001|142990338|OTHER||||||||||||||||||"The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with PD-0325901 at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or PD-0325901.~The MTD for the PD 0325901/PF-02341066 combination was 8mg BD(days1-21) and 200mg BD continuously in a 28 day cycle (Dose Level 4)."|||
71738802|NCT02510001|142990340|OTHER|||||||||||||||||The primary dose escalation analysis was to find the MTD, which was defined as the dose of PF-02341066 in combination with Binimetinib at which no more than one out of six patients experience a DLT (dose limiting toxicity). The DLT was based on observed toxicity in cycle 1, and was defined as an almost certainly or probably drug-related adverse event to PF-02341066 and/or Binimetinib.|"Binimetinib 30mg BD on days 1 - 21 every 28 days with Crizotinib 250 mg OD continuously is the MTD, the recommended dose and schedule for further evaluation in our and other trials.~This was as only one DLT was experienced in 6 evaluable patients at this final dose escalation level."|||
71738803|NCT00303485|142990370|SUPERIORITY_OR_OTHER||Difference in median|-64.2|||<|0.0001|TWO_SIDED|95.0|-80.28|-46.21|||Wilcoxon rank sum test|||||-46.21|-80.28|< 0.0001
71738804|NCT04120402|142990400|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
71738805|NCT04120402|142990401|SUPERIORITY|||||||0.014|||||||ANCOVA|||||||0.014
71738806|NCT04120402|142990402|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71738807|NCT04120402|142990403|SUPERIORITY|||||||0.518|||||||ANCOVA|||||||0.518
71738808|NCT04120402|142990404|SUPERIORITY|||||||0.028|||||||Fisher Exact|||||||0.028
71890217|NCT03529409|143302020|SUPERIORITY||Mean Difference (Net)|0.71||||0.63|TWO_SIDED|95.0|-2.24|3.67||The overall omnibus test of the time by treatment interaction was p=.55. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||3.67|-2.24|.63
71890218|NCT03529409|143302021|SUPERIORITY||Mean Difference (Net)|84.0||||0.44|TWO_SIDED|95.0|-136.0|304.0||The overall omnibus test of the time by treatment interaction was p=.38. The estimate below is for follow-up, comparing TAU to Khanya.|Mixed Models Analysis|||||304|-136|.44
71676995|NCT01608087|142872261|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.85|||||TWO_SIDED|90.0|83.91|100.54|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least square estimates of log-transformed PK endpoint for R1 and R2 were back transformed to original scale to get adjusted point estimator and interval estimates for the inter-subject ratio of the geometric means for treatments.|100.54|83.91|
71739444|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-16 antibodies.|GMT ratio for anti-HPV-16 antibody|1.21|||||TWO_SIDED|95.0|0.94|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|0.94|
71739445|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within \[0.5;2\] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.24|||||TWO_SIDED|95.0|1.0|1.55|||ANOVA|The ANOVA model on the log10 transformation of the concentration. The ANOVA model included the vaccine group as fixed effect.||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.||1.55|1.00|
71739446|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.63|1.02|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).||1.02|-3.63|
71739447|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||TWO_SIDED|95.0|-3.18|0.94|||Proc StatXact 5.0|||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.94|-3.18|
71739448|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.|GMC ratio for anti-HPV-16 antibody|0.87|||||TWO_SIDED|95.0|0.7|1.08|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||1.08|0.70|
71739449|NCT00250276|142991753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.|GMC ratio for anti-HPV-18 antibody|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|The ANOVA model on the log10 transformation of the concentration, included the vaccine groups as fixed effect (pooled 600L lot versus 80L lot).||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).||0.97|0.66|
71739450|NCT03334812|142991793|SUPERIORITY||Mean Difference (Net)|0.18||||0.1219|TWO_SIDED|95.0|-0.15|0.51|||Mixed Effect Model Repeat Measurement|||SCD/HNWB||0.51|-0.15|0.1219
71739451|NCT03334812|142991793|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5438|TWO_SIDED|95.0|-0.28|0.25|||Mixed Effect Model Repeat Measurement|||DTBT/HWB||0.25|-0.28|0.5438
71739452|NCT03334812|142991794|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.3067|TWO_SIDED|95.0|-0.19|0.31|||Mixed Effect Model Repeat Measurement|||||0.31|-0.19|0.3067
71739453|NCT03334812|142991796|SUPERIORITY||Mean Difference (Net)|26.23||||0.0404|TWO_SIDED|95.0|-3.86|56.32|||Mixed Effect Model Repeat Measurement|||Week 4||56.32|-3.86|0.0404
71739454|NCT03334812|142991796|SUPERIORITY||Mean Difference (Net)|27.82||||0.1381|TWO_SIDED|95.0|-26.5|82.1|||Mixed Effect Model Repeat Measurement|||Week 12||82.10|-26.5|0.1381
71739455|NCT03334812|142991796|SUPERIORITY||Mean Difference (Net)|23.8||||0.1168|TWO_SIDED|96.0|-19.3|66.89|||Mixed Models Analysis|||Week 28 (EOS)||66.89|-19.3|0.1168
71739456|NCT03334812|142991797|SUPERIORITY||Mean Difference (Net)|-0.01||||0.5175|TWO_SIDED|95.0|-0.26|0.25|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 12||0.25|-0.26|0.5175
71739457|NCT03334812|142991797|SUPERIORITY||Mean Difference (Net)|0.19||||0.1476|TWO_SIDED|95.0|-0.22|0.6|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 28||0.60|-0.22|0.1476
71739458|NCT01865448|142991809|SUPERIORITY_OR_OTHER|||||||0.278|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2780
71739459|NCT01865448|142991809|SUPERIORITY_OR_OTHER|||||||0.8689|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8689
71739460|NCT01865448|142991809|SUPERIORITY_OR_OTHER|||||||0.4533|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4533
71739461|NCT01865448|142991810|SUPERIORITY_OR_OTHER|||||||0.71833|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.71833
71739462|NCT01865448|142991810|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739463|NCT01865448|142991810|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739464|NCT01865448|142991811|SUPERIORITY_OR_OTHER|||||||0.519|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.51900
71739465|NCT01865448|142991811|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739466|NCT01865448|142991811|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739467|NCT01865448|142991812|SUPERIORITY_OR_OTHER|||||||0.24567|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24567
71739468|NCT01865448|142991812|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739469|NCT01865448|142991812|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739470|NCT01865448|142991813|SUPERIORITY_OR_OTHER|||||||0.9573|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9573
71739471|NCT01865448|142991813|SUPERIORITY_OR_OTHER|||||||0.5257|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5257
71739472|NCT01865448|142991813|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0657
71739473|NCT01865448|142991814|SUPERIORITY_OR_OTHER|||||||0.7474|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7474
71739474|NCT01865448|142991814|SUPERIORITY_OR_OTHER|||||||0.3745|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3745
71739475|NCT01865448|142991814|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0476
71739476|NCT01865448|142991815|SUPERIORITY_OR_OTHER|||||||0.27444|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.27444
71775101|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.16|TWO_SIDED|95.0|-1.91|-0.09||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.09|-1.91|0.16
71775102|NCT01920555|143050514|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.27|TWO_SIDED|95.0|-1.78|0.07||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.07|-1.78|0.27
71896171|NCT02495077|143314333|SUPERIORITY|||||||0.135|||||||Cochran-Mantel-Haenszel|||||||0.135
71739477|NCT01865448|142991815|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739478|NCT01865448|142991815|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739479|NCT01865448|142991816|SUPERIORITY_OR_OTHER|||||||0.28489|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28489
71739480|NCT01865448|142991816|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739481|NCT01865448|142991816|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
71739482|NCT01865448|142991817|SUPERIORITY_OR_OTHER|||||||0.04491|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.04491
71739483|NCT01865448|142991817|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739484|NCT01865448|142991817|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739485|NCT01865448|142991818|SUPERIORITY_OR_OTHER|||||||0.24396|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.24396
71739486|NCT01865448|142991818|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
71739487|NCT01865448|142991818|SUPERIORITY_OR_OTHER|||||||0.00162|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.00162
71896172|NCT02495077|143314334|SUPERIORITY|||||||0.157|||||||Chi-squared|||||||0.157
71896173|NCT02495077|143314335|SUPERIORITY|||||||0.071|||||||Chi-squared|||||||0.071
71739488|NCT01865448|142991819|SUPERIORITY_OR_OTHER|||||||0.82322|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.82322
71739489|NCT01865448|142991819|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
71739490|NCT01865448|142991819|SUPERIORITY_OR_OTHER|||||||0.25908|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.25908
71739491|NCT01865448|142991820|SUPERIORITY_OR_OTHER|||||||0.76435|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.76435
71739492|NCT01865448|142991820|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
71739493|NCT01865448|142991820|SUPERIORITY_OR_OTHER|||||||0.18876|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.18876
71739494|NCT01865448|142991821|SUPERIORITY_OR_OTHER|||||||0.40485|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.40485
71739495|NCT01865448|142991821|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739496|NCT01865448|142991821|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739497|NCT01865448|142991822|SUPERIORITY_OR_OTHER|||||||0.13911|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.13911
71739498|NCT01865448|142991822|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
71739499|NCT01865448|142991822|SUPERIORITY_OR_OTHER|||||||0.05726|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.05726
71739500|NCT01865448|142991823|SUPERIORITY_OR_OTHER|||||||0.60214|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.60214
71739501|NCT01865448|142991823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739502|NCT01865448|142991823|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739503|NCT01865448|142991824|SUPERIORITY_OR_OTHER|||||||0.66053|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.66053
71739504|NCT01865448|142991824|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739505|NCT01865448|142991824|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.05
71739506|NCT01865448|142991825|SUPERIORITY_OR_OTHER|||||||0.28743|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.28743
71739507|NCT01865448|142991825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739508|NCT01865448|142991825|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.001
71739509|NCT01865448|142991826|SUPERIORITY_OR_OTHER|||||||0.58561|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.58561
71739510|NCT01865448|142991826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||<0.001
71739511|NCT01865448|142991826|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
71739512|NCT01865448|142991827|SUPERIORITY_OR_OTHER|||||||0.1953|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1953
71739513|NCT01865448|142991827|SUPERIORITY_OR_OTHER|||||||0.0351|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0351
71739514|NCT01865448|142991827|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0795
71739515|NCT01865448|142991828|SUPERIORITY_OR_OTHER|||||||0.6664|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6664
71739516|NCT01865448|142991828|SUPERIORITY_OR_OTHER|||||||0.431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.4310
71739517|NCT01865448|142991828|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
71739518|NCT01865448|142991829|SUPERIORITY_OR_OTHER|||||||0.247|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2470
71739519|NCT01865448|142991829|SUPERIORITY_OR_OTHER|||||||0.2755|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2755
71739520|NCT01865448|142991829|SUPERIORITY_OR_OTHER|||||||0.8226|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.8226
71739521|NCT01865448|142991830|SUPERIORITY_OR_OTHER|||||||0.6779|||||||ANCOVA|||Between-Group Comparison||||0.6779
71739522|NCT01865448|142991830|SUPERIORITY_OR_OTHER|||||||0.3761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3761
71739523|NCT01865448|142991830|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0281
71739524|NCT01865448|142991831|SUPERIORITY_OR_OTHER|||||||0.8591|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8591
71739525|NCT01865448|142991831|SUPERIORITY_OR_OTHER|||||||0.0404|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0404
71739526|NCT01865448|142991831|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0474
71739527|NCT01865448|142991832|SUPERIORITY_OR_OTHER|||||||0.3187|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3187
71739528|NCT01865448|142991832|SUPERIORITY_OR_OTHER|||||||0.0482|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0482
71739529|NCT01865448|142991832|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0394
71739530|NCT01865448|142991833|SUPERIORITY_OR_OTHER|||||||0.2813|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2813
71739531|NCT01865448|142991833|SUPERIORITY_OR_OTHER|||||||0.4421|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4421
71739532|NCT01865448|142991833|SUPERIORITY_OR_OTHER|||||||0.3198|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3198
71739533|NCT01865448|142991834|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2792
71739534|NCT01865448|142991834|SUPERIORITY_OR_OTHER|||||||0.1034|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1034
71739535|NCT01865448|142991834|SUPERIORITY_OR_OTHER|||||||0.9898|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.9898
71739536|NCT01865448|142991835|SUPERIORITY_OR_OTHER|||||||0.7047|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7047
71739537|NCT01865448|142991835|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4749
71739538|NCT01865448|142991835|SUPERIORITY_OR_OTHER|||||||0.6014|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.6014
71739539|NCT01865448|142991836|SUPERIORITY_OR_OTHER|||||||0.5932|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5932
71739540|NCT01865448|142991836|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.7140
71739541|NCT01865448|142991836|SUPERIORITY_OR_OTHER|||||||0.5827|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5827
71739542|NCT01865448|142991837|SUPERIORITY_OR_OTHER|||||||0.2894|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2894
71739543|NCT01865448|142991837|SUPERIORITY_OR_OTHER|||||||0.2128|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2128
71739544|NCT01865448|142991837|SUPERIORITY_OR_OTHER|||||||0.0823|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0823
71739545|NCT01865448|142991838|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|||Between-Group Comparison||||0.3450
71739546|NCT01865448|142991838|SUPERIORITY_OR_OTHER|||||||0.1365|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1365
71739547|NCT01865448|142991838|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0073
71739548|NCT01865448|142991839|SUPERIORITY_OR_OTHER|||||||0.2333|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2333
71739549|NCT01865448|142991839|SUPERIORITY_OR_OTHER|||||||0.4292|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4292
71739550|NCT01865448|142991839|SUPERIORITY_OR_OTHER|||||||0.3356|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3356
71739551|NCT01865448|142991840|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6830
71739552|NCT01865448|142991840|SUPERIORITY_OR_OTHER|||||||0.8625|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.8625
71739553|NCT01865448|142991840|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0068
71739554|NCT01865448|142991841|SUPERIORITY_OR_OTHER|||||||0.3694|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.3694
71739555|NCT01865448|142991841|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0291
71739556|NCT01865448|142991841|SUPERIORITY_OR_OTHER|||||||0.0402|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0402
71739557|NCT01865448|142991842|SUPERIORITY_OR_OTHER|||||||0.1226|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1226
71739558|NCT01865448|142991842|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0472
71739559|NCT01865448|142991842|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0197
71739560|NCT01865448|142991843|SUPERIORITY_OR_OTHER|||||||0.8969|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8969
71775103|NCT01920555|143050515|SUPERIORITY||Mean Difference (Net)|-0.54||||0.54|TWO_SIDED|95.0|-1.25|0.17||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.17|-1.25|0.54
71739561|NCT01865448|142991843|SUPERIORITY_OR_OTHER|||||||0.7218|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7218
71739562|NCT01865448|142991843|SUPERIORITY_OR_OTHER|||||||0.4536|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4536
71739563|NCT01865448|142991844|SUPERIORITY_OR_OTHER|||||||0.8765|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.8765
71739564|NCT01865448|142991844|SUPERIORITY_OR_OTHER|||||||0.5114|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.5114
71739565|NCT01865448|142991844|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0237
71739566|NCT01865448|142991845|SUPERIORITY_OR_OTHER|||||||0.2914|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2914
71739567|NCT01865448|142991845|SUPERIORITY_OR_OTHER|||||||0.5594|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5594
71739568|NCT01865448|142991845|SUPERIORITY_OR_OTHER|||||||0.2532|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2532
71739569|NCT01865448|142991846|SUPERIORITY_OR_OTHER|||||||0.0528|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0528
71739570|NCT01865448|142991846|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1920
71739571|NCT01865448|142991846|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0011
71739572|NCT01865448|142991847|SUPERIORITY_OR_OTHER|||||||0.2999|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2999
71739573|NCT01865448|142991847|SUPERIORITY_OR_OTHER|||||||0.5184|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5184
71739574|NCT01865448|142991847|SUPERIORITY_OR_OTHER|||||||0.0564|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0564
71739575|NCT01865448|142991848|SUPERIORITY_OR_OTHER|||||||0.0783|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0783
71739576|NCT01865448|142991848|SUPERIORITY_OR_OTHER|||||||0.1263|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1263
71739577|NCT01865448|142991848|SUPERIORITY_OR_OTHER|||||||0.6484|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.6484
71739578|NCT01865448|142991849|SUPERIORITY_OR_OTHER|||||||0.6896|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.6896
71739579|NCT01865448|142991849|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0980
71739580|NCT01865448|142991849|SUPERIORITY_OR_OTHER|||||||0.3526|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.3526
71739581|NCT01865448|142991850|SUPERIORITY_OR_OTHER|||||||0.9662|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9662
71739582|NCT01865448|142991850|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.1450
71739583|NCT01865448|142991850|SUPERIORITY_OR_OTHER|||||||0.3811|TWO_SIDED||||||Paired t-test|||||||0.3811
71739584|NCT01865448|142991851|SUPERIORITY_OR_OTHER|||||||0.2643|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.2643
71739585|NCT01865448|142991851|SUPERIORITY_OR_OTHER|||||||0.0761|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0761
71739586|NCT01865448|142991851|SUPERIORITY_OR_OTHER|||||||0.1342|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.1342
71739587|NCT01865448|142991852|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1410
71739588|NCT01865448|142991852|SUPERIORITY_OR_OTHER|||||||0.3774|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.3774
71739589|NCT01865448|142991852|SUPERIORITY_OR_OTHER|||||||0.1811|TWO_SIDED||||||Paired t-test|||||||0.1811
71739590|NCT01865448|142991853|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
71739591|NCT01865448|142991853|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71739592|NCT01865448|142991853|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71739593|NCT01865448|142991854|SUPERIORITY_OR_OTHER|||||||0.5893|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.5893
71739594|NCT01865448|142991854|SUPERIORITY_OR_OTHER|||||||0.0431|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0431
71739595|NCT01865448|142991854|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0066
71739596|NCT01865448|142991855|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||<0.0001
71739597|NCT01865448|142991855|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71775104|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.78|0.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.58|-0.78|1.00
71739598|NCT01865448|142991855|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||<0.0001
71739599|NCT01865448|142991856|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.9850
71896174|NCT02495077|143314336|SUPERIORITY|||||||0.543|||||||t-test, 2 sided|||||||0.543
71896175|NCT02495077|143314337|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
71739600|NCT01865448|142991856|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data||||0.0049
71739601|NCT01865448|142991856|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Paired t-test|||||||0.0062
71739602|NCT01865448|142991857|SUPERIORITY_OR_OTHER|||||||0.1946|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.1946
71739603|NCT01865448|142991857|SUPERIORITY_OR_OTHER|||||||0.2337|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.2337
71739604|NCT01865448|142991857|SUPERIORITY_OR_OTHER|||||||0.9188|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.9188
71739605|NCT01865448|142991858|SUPERIORITY_OR_OTHER|||||||0.7964|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.7964
71739606|NCT01865448|142991858|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.7680
71739607|NCT01865448|142991858|SUPERIORITY_OR_OTHER|||||||0.5669|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.5669
71739608|NCT01865448|142991859|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Between-Group Comparison||||0.0320
71896176|NCT02495077|143314338|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||0.275
71896177|NCT02495077|143314339|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.300
71896178|NCT02495077|143314340|SUPERIORITY|||||||0.152|||||||t-test, 2 sided|||||||0.152
71739609|NCT01865448|142991859|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.0220
71739610|NCT01865448|142991859|SUPERIORITY_OR_OTHER|||||||0.4563|TWO_SIDED||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data||||0.4563
71739611|NCT01865448|142991860|SUPERIORITY_OR_OTHER|||||||0.72828|TWO_SIDED||||||Fisher Exact|||Between-Group Comparison||||0.72828
71739612|NCT03004911|142991889|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.740
71739613|NCT03004911|142991890|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.890
71739614|NCT03004911|142991891|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||||||0.747
71739615|NCT03004911|142991892|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71739616|NCT03004911|142991893|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
71739617|NCT02451917|142991930|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.||||||0.00045||||||The intention-to-treat population consisted of all randomized participants.|ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.||||0.00045
71813037|NCT00514683|143128436|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.1944|TWO_SIDED|95.0|0.167|1.438|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.438|0.167|0.1944
71813038|NCT00514683|143128436|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.0324|TWO_SIDED|95.0|0.056|0.882|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||0.882|0.056|0.0324
71813039|NCT00514683|143128437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.5206|TWO_SIDED|95.0|0.326|1.765|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.765|0.326|0.5206
71813040|NCT00514683|143128437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841||||0.6862|TWO_SIDED|95.0|0.362|1.952|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.952|0.362|0.6862
71739618|NCT02451917|142991931|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov-Smirnov statistics) was performed at baseline for each sequence of the therapy.|number of total events per patient|0.0||||0.35|TWO_SIDED|||||Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks||||0.35
71739619|NCT02451917|142991931|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|number of nocturnal events per patient|0.0||||0.047|TWO_SIDED|||||Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.047
71739620|NCT02451917|142991932|NON_INFERIORITY_OR_EQUIVALENCE|t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.|||||<|0.05|||||||t-test, 1 sided|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||<0.05
71739621|NCT02451917|142991933|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.668|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.668
71739622|NCT02451917|142991934|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
71739623|NCT02451917|142991935|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.999
71739624|NCT02451917|142991936|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.994|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||0.994
71739625|NCT04737278|142991947|OTHER|test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71775105|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.03|TWO_SIDED|95.0|-1.64|-0.31||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.31|-1.64|0.03
71775106|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.54|TWO_SIDED|95.0|-1.24|0.11||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.11|-1.24|0.54
71739626|NCT04737278|142991947|OTHER|||||||0.01|||||||t-test, 2 sided|||test of the hypothesis that the score on day 28 is different than the baseline score||||0.01
71739627|NCT04737278|142991948|OTHER|||||||0.15|||||||t-test, 2 sided|||Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p\<0.05. Within group comparisons were made using the paired Student's t test.||||0.15
71739628|NCT04737278|142991949|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71739629|NCT04737278|142991949|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||comparison made between placebo and Cunermuspir at baseline||||0.03
71739630|NCT04737278|142991949|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||comparison made at day 28||||0.01
71739631|NCT04737278|142991949|OTHER|||||||0.07|||||||t-test, 2 sided|||comparison between baseline and day 28||||0.07
71739632|NCT04737278|142991950|OTHER|||||||0.54|||||||Fisher Exact|||base line between group comparisons||||0.54
71739633|NCT04737278|142991950|OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
71739634|NCT04737278|142991951|OTHER|||||||0.54|||||||ANCOVA|||||||0.54
71739635|NCT04737278|142991952|OTHER||||||<|0.01|||||||ANCOVA|||The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28||||<0.01
71739636|NCT04737278|142991953|OTHER|||||||0.31|||||||ANCOVA|||||||0.31
71739637|NCT04737278|142991954|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
71739638|NCT04737278|142991955|OTHER|||||||0.84|||||||ANCOVA|||||||0.84
71739639|NCT04737278|142991956|OTHER|||||||0.63|||||||ANCOVA|||||||0.63
71739640|NCT04737278|142991957|OTHER|||||||0.05|||||||ANCOVA|||||||0.05
71739641|NCT04737278|142991958|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71739642|NCT04737278|142991959|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71739643|NCT04737278|142991960|OTHER|||||||0.48|||||||ANCOVA|||||||0.48
71661324|NCT00911807|142836328|SUPERIORITY_OR_OTHER||Mean Square (Factor Treatment)|19.59||||0.6348||||||ANCOVA F-test. The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|ANCOVA|ANCOVA with the week 28 ADAS-cog+ change score as dependent variable and the ADAS-cog+ baseline score as a covariate.||The null-hypothesis stated no differences between the three treatment groups regarding the mean change from baseline in ADAS-cog+ at week 28. A sample size of approximately 60 evaluable patients per treatment arm was estimated to allow for the detection of a significant group difference of two points in ADAS-cog+ week 28 change score (standard deviation \[SD\] 3.3) between the three groups with a power of \> 80% and a probability level of alpha = 0.05 (two-sided).||||0.6348
71739644|NCT04737278|142991961|OTHER|||||||0.06|||||||ANCOVA|||||||0.06
71739645|NCT04737278|142991962|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71739646|NCT04737278|142991963|OTHER|||||||0.03|||||||ANCOVA|||||||0.03
71739647|NCT04737278|142991963|OTHER|||||||0.05|||||||t-test, 2 sided|||comparison of neutrophils from baseline to day 28||||0.05
71739648|NCT04737278|142991964|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71739649|NCT04737278|142991965|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||comparison of baseline values||||0.47
71739650|NCT04737278|142991965|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||comparison performed on data from day 28||||0.24
71739651|NCT04737278|142991966|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||comparison of eosinophil counts at day 28||||0.11
71896179|NCT02495077|143314341|SUPERIORITY|||||||0.181|||||||t-test, 2 sided|||||||0.181
71676996|NCT01011465|142872277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.03||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.03
71676997|NCT01011465|142872277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.89||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.89
71739652|NCT04737278|142991967|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The day 28 basophil counts on day 28 were compared between the two arms of this study.||||0.98
71739653|NCT04737278|142991968|OTHER|||||||0.025||||||This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.|ANOVA|||"All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php~Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:~http://vassarstats.net/anova2u.html"||||0.025
71739654|NCT04737278|142991969|OTHER|||||||0.06|||||||t-test, 2 sided|||Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.||||0.06
71739655|NCT04737278|142991969|OTHER|||||||0.04|||||||t-test, 2 sided|||Comparison of enrollment baseline blood glucose and day 28 in the placebo arm||||0.04
71739656|NCT04737278|142991969|OTHER|||||||0.92|||||||ANCOVA|||||||0.92
71739657|NCT04737278|142991970|OTHER|||||||0.51|||||||ANCOVA|||||||0.51
71739658|NCT04737278|142991971|OTHER|||||||0.38|||||||ANCOVA|||||||0.38
71739659|NCT04737278|142991972|OTHER|||||||0.01|||||||ANCOVA|||||||0.01
71739660|NCT04737278|142991973|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
71739661|NCT04737278|142991973|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71739662|NCT04737278|142991973|OTHER|||||||0.01|||||||t-test, 2 sided|||Blood sodium concentration between baseline and day 28 in the Placebo group.||||0.01
71739663|NCT04737278|142991974|OTHER|||||||0.58|||||||ANCOVA|||||||0.58
71739664|NCT04737278|142991974|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants||||<0.001
71739665|NCT04737278|142991974|OTHER||||||<|0.001|||||||t-test, 2 sided|||comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.||||<0.001
71739666|NCT04737278|142991975|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
71739667|NCT04737278|142991975|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison between baseline and day 28 chloride concentrations in the Cunermuspir group||||0.003
71739668|NCT04737278|142991975|OTHER|||||||0.003|||||||t-test, 2 sided|||comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants||||0.003
71739669|NCT04737278|142991976|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Bilirubin concentrations between Placebo and Cunermuspir compared at day 28||||0.36
71739670|NCT04737278|142991976|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-Rank||comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm||||0.72
71739671|NCT04737278|142991976|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm||||0.35
71739672|NCT04737278|142991977|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71739673|NCT04737278|142991977|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values in Cunermuspir group||||0.4
71739674|NCT04737278|142991977|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||comparison between baseline and day 28 values for the Placebo Arm||||0.8
71739675|NCT04737278|142991978|OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo||||0.62
71739676|NCT04737278|142991978|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison||||0.24
71739677|NCT04737278|142991978|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||baseline to day 28 comparison of AST activity in Placebo group||||0.11
71739678|NCT04737278|142991979|OTHER|||||||0.11||||||Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28|Wilcoxon (Mann-Whitney)|||comparison between placebo and Cunermuspir at day 28||||0.11
71739679|NCT04737278|142991979|OTHER|||||||0.01|||||||Wilcoxon Signed Rank|||Comparison of GGT activities in participants' blood at baseline and on day 28||||0.01
71739680|NCT04737278|142991979|OTHER|||||||0.97|||||||Wilcoxon Signed-Rank|||Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28||||0.97
71739681|NCT04737278|142991980|OTHER|||||||0.03|||||||ANCOVA|||Between group comparisons were made using ANCOVA||||0.03
71739682|NCT04737278|142991980|OTHER|||||||0.1|||||||t-test, 2 sided|||comparison of baseline with day 28||||0.10
71739683|NCT04737278|142991980|OTHER|||||||0.89|||||||t-test, 2 sided|||comparison between baseline and day 28 serum copper concentrations in the Placebo Arm||||0.89
71739684|NCT02255461|142991997|OTHER|Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
71739685|NCT02255461|142991998|OTHER|Ordinal logistic regression model was built for outcome lymphopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.97|1.15||||||||1.15|0.97|
71775107|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.19||||1|TWO_SIDED|95.0|-0.96|0.57||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.57|-0.96|1.00
71775108|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.21||||1|TWO_SIDED|95.0|-0.93|0.51||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.51|-0.93|1.00
71739686|NCT02255461|142991999|OTHER|Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.01|1.2||||||||1.20|1.01|
71775109|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.52|TWO_SIDED|95.0|-1.35|0.06||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.06|-1.35|0.52
71775110|NCT01920555|143050515|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.54|TWO_SIDED|95.0|-1.33|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-1.33|0.54
71775111|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.74|TWO_SIDED|95.0|-0.79|0.08||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.08|-0.79|0.74
71739687|NCT01504412|142992008|SUPERIORITY||Hazard Ratio (HR)|-0.42||||0.1995|TWO_SIDED|95.0|-0.99|0.15||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.15|-0.99|0.1995
71739688|NCT01504412|142992008|SUPERIORITY||Hazard Ratio (HR)|-0.37||||0.2886|TWO_SIDED|95.0|-0.93|0.2||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.20|-0.93|0.2886
71739689|NCT01504412|142992008|SUPERIORITY||Hazard Ratio (HR)|-0.3||||0.4704|TWO_SIDED|95.0|-0.87|0.27||Dunnett method was used for adjustment of multiple testing.|ANCOVA|||||0.27|-0.87|0.4704
71739690|NCT01504412|142992009|SUPERIORITY||Least squares mean difference|-5.2||||0.0691|TWO_SIDED|95.0|-10.8|0.4|||ANCOVA|||This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.||0.4|-10.8|0.0691
71739691|NCT01504412|142992009|SUPERIORITY||Least squares mean difference|-5.4||||0.0577|TWO_SIDED|95.0|-10.9|0.2|||ANCOVA|||This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.||0.2|-10.9|0.0577
71739692|NCT01504412|142992009|SUPERIORITY||Least squares mean difference|-7.4||||0.0093|TWO_SIDED|95.0|-13.0|-1.8|||ANCOVA|||This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.||-1.8|-13.0|0.0093
71739693|NCT01449006|142992010|SUPERIORITY_OR_OTHER|||||||0.05||||||This pilot study was conducted to generate effect sizes for a potential larger investigation. The study design and small sample size had limited power to detect a statistically significant effect at p\<0.05, so no p-value threshold was strictly set.|Mixed Models Analysis|41 data points included (control n=14; maraviroc: n=27); n=1 control did not attend 12-month visit.||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm\*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.||||0.05
71739694|NCT01449006|142992010|SUPERIORITY_OR_OTHER||Cohen's d|0.77|||||TWO_SIDED|90.0|-0.19|1.71|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 6-months was assessed by generating Cohen's d statistic and 90% confidence interval (CI) around the estimate.||1.71|-0.19|
71661325|NCT00911807|142836328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.583||95.0|-2.891|1.63||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'||1.630|-2.891|0.5830
71739695|NCT01449006|142992010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|90.0|-0.47|1.55|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 12-months was assessed by generating Cohen's d statistic and 90%CI around the estimate.||1.55|-0.47|
71739696|NCT01449006|142992011|SUPERIORITY_OR_OTHER|||||||0.82|||||||ANOVA|||Change in CSF neopterin levels was analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.82
71739697|NCT01449006|142992012|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.49
71739698|NCT01449006|142992012|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.94
71739699|NCT01449006|142992012|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.80
71739700|NCT01449006|142992012|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.72
71739701|NCT01449006|142992013|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
71739702|NCT01449006|142992013|SUPERIORITY_OR_OTHER|||||||0.66|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.66
71739703|NCT01449006|142992013|SUPERIORITY_OR_OTHER|||||||0.56|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.56
71739704|NCT01449006|142992013|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.29
71739705|NCT01449006|142992013|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm\*time interaction as fixed effects.||||0.95
71739706|NCT03350815|142992014|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.25||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of ASDAS inactive disease response by visit - in Treatment Period 2 (nonresponder imputation)||2.25|0.28|
71739707|NCT03350815|142992015|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|2.08|||||TWO_SIDED|95.0|0.5|8.66||No P value as no hypothesis was tested|Regression, Logistic|||Statistical analysis (logistic regression) of reduction in ASDAS \>= 1.1 response by visit - in Treatment Period 2 (nonresponder imputation)||8.66|0.50|
71739708|NCT03350815|142992016|OTHER|Statistical hypothesis tests were not performed for this study|Least Square Mean of Treatment Differenc|0.23|STANDARD_ERROR_OF_MEAN|0.263|||TWO_SIDED|95.0|-0.29|0.75||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Mixed Models Analysis|||Statistical analysis of total BASDAI change from Week 16 using MMRM - in Treatment Period 2 (FAS)||0.75|-0.29|
71739709|NCT03350815|142992017|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.5|3.24||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI50 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.24|0.50|
71739710|NCT03350815|142992018|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.43|1.73||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables|Regression, Logistic|||Statistical analysis (logistic regression) of BASDAI20 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||1.73|0.43|
71739711|NCT03350815|142992019|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.49|3.46||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status (naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS40 response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||3.46|0.49|
71739712|NCT03350815|142992020|OTHER|Statistical hypothesis tests were not performed for this study|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.44|2.41||Odds ratio and 95% confidence interval for odds ratio are from a logistic regression model with treatment (2 treatment groups), TNF-alpha inhibitor status(naive, inadequate responder) and Week 16 body weight (kg) as explanatory variables.|Regression, Logistic|||Statistical analysis (logistic regression) of ASAS partial remission response by visit - in Treatment Period 2 (nonresponder imputation) (FAS)||2.41|0.44|
71813041|NCT00514683|143128437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.517||||0.1891|TWO_SIDED|95.0|0.193|1.384|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.384|0.193|0.1891
71813042|NCT00514683|143128437|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.158||||0.0161|TWO_SIDED|95.0|0.035|0.711|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.711|0.035|0.0161
71813043|NCT00514683|143128438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.173||||0.7449|TWO_SIDED|95.0|0.448|3.072|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.072|0.448|0.7449
71739713|NCT03350815|142992021|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.74|1.01||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||Statistical analysis of change from Week 16 in ASAS-Health Index using MMRM by visit - in Treatment Period 2 (FAS)||1.01|-0.74|
71739714|NCT03350815|142992022|OTHER|Statistical hypothesis tests were not performed for this study|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.62|1.61||Least squares means (LSMs) of the treatment groups, LSM treatment difference and 95% confidence interval for treatment difference are from mixed-effects model repeated measures (MMRM) with treatment, visit and TNF-alpha inhibitor status as factors|Regression, Logistic|||||1.61|-3.62|
71739715|NCT02936843|142992035|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided||TTEST, two sided||||0.41
71739716|NCT00555672|142992075|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.3|||||TWO_SIDED|95.0|13.3|45.5|||Fisher Exact|Exact Method based on the F Distribution.||||45.5|13.3|
71739717|NCT04759157|142992079|SUPERIORITY|||||||0.3|||||||mixed model|||||||.30
71739718|NCT04759157|142992080|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.05||0.206|TWO_SIDED|95.0|-6.63|1.43|||Mixed Models Analysis||This estimate is comparing intervention to control from baseline to 3 month for both patients and partners|We conducted multilevel models evaluating sleep disturbance score by assessment, group and patient versus partner status.||1.43|-6.63|.206
71739719|NCT00939562|142992087|SUPERIORITY_OR_OTHER||Ratio|102.95||||||90.0|94.74|111.86|||||The adjusted mean differences and 90% confidence intervals (CIs) were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||111.86|94.74|
71739720|NCT00939562|142992088|SUPERIORITY_OR_OTHER||Ratio|104.67||||||90.0|98.95|110.73|||||The adjusted mean differences and 90% CIs were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).||110.73|98.95|
71739721|NCT04531241|142992107|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-6.8|1.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||1.1|-6.8|
71739722|NCT04531241|142992108|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.0199|0.0|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Low Luminance High Contrast||0.0|-0.0199|
71739723|NCT04531241|142992108|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 0.05 logMAR unit difference in logMAR visual acuity at LLHC and HLLC lighting conditions at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 0.05 logMAR units was used.|Least-Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.0066|||TWO_SIDED|95.0|-0.0173|0.0087|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|High Luminance Low Contrast||0.0087|-0.0173|
71739724|NCT04531241|142992109|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have a 1 hour difference in average daily wear time at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of 1 hour was used.|Least-Square Mean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.0731|||TWO_SIDED|95.0|-0.1968|0.0933|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.0933|-0.1968|
71739725|NCT04531241|142992110|NON_INFERIORITY|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort and vision at the 1-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05). A non-inferiority margin of -5 points was used.|Least-Square Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|95.0|-5.5|0.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||0.3|-5.5|
71739726|NCT02708355|142992127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.028||||0.0442|TWO_SIDED|95.0|1.001|1.055|||Regression, Logistic|||Association between percentage of time with intragastric pH\>4 and relief of 24 -hour heartburn was assessed using logistic regression model with relief of 24- hour heartburn at Day 14 as dependent variable and change in percentage of time with intragastric pH\>4 as the independent variable, controlling for age, sex, and body mass index (BMI).||1.055|1.001|0.0442
71739727|NCT01320202|142992128|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.4||0.011|TWO_SIDED|||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
71739728|NCT00635882|142992143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
71739729|NCT00635882|142992143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.003
71739730|NCT00635882|142992143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.018
71739731|NCT00635882|142992144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||<0.001
71739732|NCT00635882|142992144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
71739733|NCT00635882|142992144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."||||0.002
71739734|NCT00635882|142992145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.024
71739735|NCT00635882|142992145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.051
71661326|NCT00911807|142836328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.3434||95.0|-3.324|1.163||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.163|-3.324|0.3434
71739736|NCT00635882|142992145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.336|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."||||0.336
71739737|NCT00635882|142992146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.120
71739738|NCT00635882|142992146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.103
71676998|NCT01011465|142872277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.52||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.||||0.52
71739739|NCT00635882|142992146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."||||0.048
71739740|NCT00635882|142992147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way analysis of variance (ANOVA) model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.018
71739741|NCT00635882|142992147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.261
71739742|NCT00635882|142992147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.334
71739743|NCT00635882|142992148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.037
71739744|NCT00635882|142992148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.643
71739745|NCT00635882|142992148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.963
71739746|NCT00635882|142992149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
71739747|NCT00635882|142992149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.002
71739748|NCT00635882|142992149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
71739749|NCT00635882|142992150|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||<0.001
71739750|NCT00635882|142992150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.057
71739751|NCT00635882|142992150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."||||0.005
71739752|NCT01153724|142992237|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|113.29|STANDARD_DEVIATION|13.6||0.0101|TWO_SIDED|90.0|105.893|121.197||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||121.197|105.893|0.0101
71739753|NCT01153724|142992238|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|108.78|STANDARD_DEVIATION|15.5||0.0009|TWO_SIDED|90.0|101.59|116.487||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||116.487|101.590|0.0009
71739754|NCT01153724|142992238|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean|85.98|STANDARD_DEVIATION|19.4||0.0711|TWO_SIDED|90.0|79.277|93.253||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||93.253|79.277|0.0711
71739755|NCT01153724|142992241|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|114.83|STANDARD_DEVIATION|33.5||0.1539|TWO_SIDED|90.0|99.94|131.932||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol||131.932|99.940|0.1539
71739756|NCT01153724|142992241|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.48|STANDARD_DEVIATION|1.068||0.8574|TWO_SIDED|90.0|66.619|83.266||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide||83.266|66.619|0.8574
71775112|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-0.37|0.45||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.45|-0.37|1.00
71775113|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.02|TWO_SIDED|95.0|-1.01|-0.21||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.21|-1.01|0.02
71775114|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.8|TWO_SIDED|95.0|-0.72|0.1||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.10|-0.72|0.80
71739757|NCT01153724|142992242|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Adjusted geometric mean ratio|74.08|STANDARD_DEVIATION|14.6||0.9646|TWO_SIDED|90.0|69.105|79.418||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol||79.418|69.105|0.9646
71739758|NCT00870545|142992295|SUPERIORITY_OR_OTHER|||||||0.003||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||.003
71739759|NCT00870545|142992296|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 and 12 months)||||.20
71739760|NCT00870545|142992297|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)||||<.001
71739761|NCT00870545|142992298|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, 12 months)||||.26
71813044|NCT00514683|143128438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.316||||0.0925|TWO_SIDED|95.0|0.083|1.209|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.209|0.083|0.0925
71661327|NCT00911807|142836328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.6962||95.0|-2.719|1.819||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.||1.819|-2.719|0.6962
71661328|NCT03316378|142836363|SUPERIORITY||Mean Difference (Final Values)|73.8||||0.44|TWO_SIDED|||||Adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||0.44
71661329|NCT03316378|142836363|SUPERIORITY||Mean Difference (Final Values)|31.7||||0.08|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.08
71661330|NCT03316378|142836364|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||<0.001
71661331|NCT03316378|142836364|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.012|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||0.012
71739762|NCT00870545|142992299|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in scores over time (baseline, 6 months, and 12 months)||||.04
71661332|NCT03316378|142836365|SUPERIORITY||Mean Difference (Final Values)|0.15||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups||||1.0
71661333|NCT03316378|142836365|SUPERIORITY||Mean Difference (Final Values)|0.05||||1|TWO_SIDED|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time||||1.0
71661334|NCT01672970|142836381|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical analysis at Month 3||||0.000
71661335|NCT01672970|142836381|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71661336|NCT01672970|142836382|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.001
71661337|NCT01672970|142836382|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.005
71661338|NCT01672970|142836383|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71661339|NCT01672970|142836383|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71661340|NCT01672970|142836384|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71661341|NCT01672970|142836384|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon Signed Rank Test|||||||0.001
71661342|NCT01672970|142836387|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71661343|NCT01672970|142836387|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71661344|NCT01672970|142836388|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71661345|NCT01672970|142836388|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71661346|NCT01672970|142836393|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71661347|NCT01672970|142836393|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71661348|NCT01672970|142836394|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71661349|NCT01672970|142836394|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71661350|NCT01672970|142836395|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3||||0.000
71661351|NCT01672970|142836395|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6||||0.000
71661352|NCT01672970|142836396|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71661353|NCT01672970|142836396|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71661354|NCT01672970|142836397|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71739763|NCT00870545|142992300|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, and 12 months)||||.10
71739764|NCT04230213|142992301|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (percentage)|102.56|||||TWO_SIDED|90.0|89.78|117.17|||||Analysis was performed using analysis of variance (ANOVA) model.|||117.17|89.78|
71739765|NCT04230213|142992302|EQUIVALENCE|Equivalence was to be determined if the 90% confidence interval of the geometric mean ratio falls within the 80% to 125% range.|Geometric mean ratio (Percentage)|105.31|||||TWO_SIDED|90.0|89.16|124.39|||||Analysis was performed using ANOVA model.|||124.39|89.16|
71739766|NCT00524472|142992332|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.0043|TWO_SIDED|95.0|0.39|0.97||"P-values for combined sites: significant if P \< 0.0085 for efficacy. Adjusted for interim analysis.~Confidence intervals adjusted for interim analysis."|Cochran-Mantel-Haenszel||Hyperinsulinemic-normoglycemic clamp|||0.97|0.39|0.0043
71739767|NCT00524472|142992333|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.29|TWO_SIDED|95.0|0.75|1.13|||Cochran-Mantel-Haenszel||HN vs. standard|||1.13|0.75|0.29
71739768|NCT00524472|142992334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.99|TWO_SIDED|95.0|0.91|1.21|||Regression, Cox|||||1.21|0.91|0.99
71739769|NCT00524472|142992335|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.025|TWO_SIDED|95.0|0.98|1.31|||Regression, Cox||HN vs. Standard|||1.31|0.98|0.025
71739770|NCT00524472|142992336|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.52||||0.12|TWO_SIDED|95.0|0.74|3.11|||Cochran-Mantel-Haenszel||HN vs. standard|||3.11|0.74|0.12
71890513|NCT00484315|143302478|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.|Median Difference (Final Values)|-0.57|STANDARD_DEVIATION|0.0155||0.9996|ONE_SIDED|95.0||1.85||The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was \< 4.1%, given the data observed.|Bayesian modeling||Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.|Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.||1.85||0.9996
71890514|NCT00484315|143302479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.|Mean Difference (Final Values)|-0.0294|STANDARD_DEVIATION|0.08253||0.997|ONE_SIDED|95.0||0.1078||P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was \< 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.|Bayesian modeling||Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.|Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.||0.1078||0.9970
71890515|NCT01955707|143302524|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.08|||||TWO_SIDED|90.0|-0.09|0.26||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tissue plasminogen activator (tPA) use.||0.26|-0.09|
71890516|NCT01955707|143302524|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.779|TWO_SIDED|90.0|0.91|1.3||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.30|0.91|0.779
71890517|NCT01955707|143302525|SUPERIORITY_OR_OTHER||adjusted mean difference (log-scale)|0.09|||||TWO_SIDED|90.0|-0.09|0.27||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.27|-0.09|
71890518|NCT01955707|143302525|SUPERIORITY_OR_OTHER||ratio of relative growth|1.09||||0.797|TWO_SIDED|90.0|0.92|1.31||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.31|0.92|0.797
71890519|NCT01955707|143302526|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.05|||||TWO_SIDED|90.0|-0.13|0.24||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.24|-0.13|
71661355|NCT01672970|142836397|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71890520|NCT01955707|143302526|SUPERIORITY_OR_OTHER||ratio of relative growth|1.05||||0.684|TWO_SIDED|90.0|0.88|1.27||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.27|0.88|0.684
71890521|NCT01955707|143302527|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|0.0|||||TWO_SIDED|90.0|-0.12|0.11||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.11|-0.12|
71890522|NCT01955707|143302527|SUPERIORITY_OR_OTHER||ratio of relative growth|1.0||||0.487|TWO_SIDED|90.0|0.89|1.12||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.12|0.89|0.487
71661356|NCT01672970|142836398|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3||||0.000
71661357|NCT01672970|142836398|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6||||0.000
71661358|NCT01997229|142836399|SUPERIORITY||Mean Difference (Net)|-11.7||||0.0698|TWO_SIDED|95.0|-24.33|0.96|||ANCOVA|||||0.96|-24.33|0.0698
71661359|NCT02304991|142836400|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.002
71661360|NCT02304991|142836401|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Intent to treat; participants not completing the DBPCFC considered to have challenge score of zero||||0.0005
71833539|NCT04992390|143171800|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.15|||<=|0.001|TWO_SIDED|95.0|-3.22|-1.08||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your work functioning?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.08|-3.22|<= 0.001
71833540|NCT04992390|143171800|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.59|||<=|0.001|TWO_SIDED|95.0|-3.67|-1.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intrusive memory ratings, 'How much did your intrusive memories affect your functioning in other areas of your life?' (treatment effects for between-arm comparisons) at week 4. For full information on statistical analysis see Iyadurai et al 2023, https://doi.org/10.1038/s41398-023-02578-0|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.51|-3.67|<= 0.001
71833541|NCT04992390|143171803|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.8|||<=|0.001|TWO_SIDED|95.0|-1.08|-0.53||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Total Score (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.53|-1.08|<= 0.001
71833542|NCT04992390|143171803|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.95|||<=|0.001|TWO_SIDED|95.0|-1.27|-0.62||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Intrusion Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.62|-1.27|<= 0.001
71833543|NCT04992390|143171803|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.75|||<=|0.001|TWO_SIDED|95.0|-1.09|-0.42||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Avoidance Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.42|-1.09|<= 0.001
71833544|NCT04992390|143171803|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.7|||<=|0.001|TWO_SIDED|95.0|-0.97|-0.44||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Impact of Event Scale-Revised Hyperarousal Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.44|-0.97|<= 0.001
71890523|NCT01955707|143302528|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.14|0.1||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.||0.10|-0.14|
71890524|NCT01955707|143302528|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.402|TWO_SIDED|90.0|0.87|1.11||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.11|0.87|0.402
71661361|NCT02304991|142836402|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71890525|NCT01955707|143302529|SUPERIORITY_OR_OTHER||Adjusted mean difference (log-scale)|-0.02|||||TWO_SIDED|90.0|-0.18|0.13||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to Day 5 using an autoregressive variance-covariance matrix structure. The model adjusts for for treatment, log baseline DWI volume, treatment time window, and tPA use.||0.13|-0.18|
71833545|NCT04992390|143171804|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-2.29|||<=|0.001|TWO_SIDED|95.0|-3.52|-1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for PTSD Checklist for DSM-5 (PCL-5) 4-item version (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-1.07|-3.52|<= 0.001
71833546|NCT04992390|143171805|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|5.38|||<=|0.001|TWO_SIDED|95.0|2.56|8.2||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Sleep Condition Indicator (SCI) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|8.20|2.56|<= 0.001
71833547|NCT04992390|143171806|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.93|||<=|0.05|TWO_SIDED|95.0|-1.68|-0.17||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Generalised Anxiety Disorder 2-item scale (GAD-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.17|-1.68|<=0.05
71833548|NCT04992390|143171807|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.52|||>|0.05|TWO_SIDED|95.0|-1.23|0.19||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Patient Health Questionnaire 2-item version (PHQ-2) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons.(Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.19|-1.23|> .05
71833549|NCT04992390|143171808|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-6.49|||<=|0.001|TWO_SIDED|95.0|-8.48|-4.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Psychological Outcome Profiles (PSYCHLOPS) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.51|-8.48|<= 0.001
71833550|NCT04992390|143171809|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-9.78|||<=|0.001|TWO_SIDED|95.0|-15.06|-4.5||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for World Health Organization Disability Assessment Schedule 12-item version (WHODAS 2.0) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-4.50|-15.06|<= 0.001
71890526|NCT01955707|143302529|SUPERIORITY_OR_OTHER||ratio of relative growth|0.98||||0.394|TWO_SIDED|90.0|0.84|1.14||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.|||1.14|0.84|0.394
71661362|NCT02304991|142836403|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||0.01
71833551|NCT04992390|143171810|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|12.32|||<=|0.01|TWO_SIDED|95.0|4.61|20.04||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for 5-level European Quality of Life 5 Dimension (EQ-5D-5L) (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 for EQ-5D-5L subscale comparisons and Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|20.04|4.61|<= 0.01
71833552|NCT04992390|143171811|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|0.46|||<=|0.001|TWO_SIDED|95.0|0.2|0.71||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.71|0.20|<= 0.001
71833553|NCT04992390|143171811|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.61|||<=|0.001|TWO_SIDED|95.0|-0.87|-0.34||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Subscale (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|-0.34|-0.87|<= 0.001
71833554|NCT04992390|143171812|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.5|||>|0.05|TWO_SIDED|95.0|0.64|3.51||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for Sickness absence (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|3.51|0.64|> .05
71833555|NCT04992390|143171813|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Mean Difference (Final Values)|-0.86|||>|0.05|TWO_SIDED|95.0|-2.2|0.49||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Linear|||ITT analysis for Intention to leave job (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Tables for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|0.49|-2.20|> .05
71845271|NCT05886777|143204384|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.13|||||TWO_SIDED|97.5|0.909|1.402|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.402|0.909|
71890527|NCT01955707|143302530|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|-0.25||||0.427|TWO_SIDED|90.0|-2.48|1.98||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at 24 hours. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||1.98|-2.48|0.427
71890528|NCT01955707|143302530|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.71||||0.896|TWO_SIDED|90.0|-0.52|3.94||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 5. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||3.94|-0.52|0.896
71661363|NCT02304991|142836404|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Per protocol analysis of patients with available samples.||||<0.0001
71739771|NCT00524472|142992337|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.085|TWO_SIDED|95.0|0.72|1.07|||Cochran-Mantel-Haenszel||HN vs. Standard|||1.07|0.72|0.085
71739772|NCT02508428|142992338|EQUIVALENCE|Differences in survivorship among the Marathon and Enduron liners were evaluated with a Log Rank test.|||||<|0.001||||||A p-value of 0.05 was used as the threshold for statistical significance.|Log Rank|||Survivorship was evaluated using liner revision for wear/osteolysis as an endpoint using a Kaplan-Meier analysis.||||<0.001
71739773|NCT02508428|142992339|EQUIVALENCE|"Since the null hypothesis assumed that the wear rates were not different, Equivalence has been specified for the Type of Statistical Test"|Mean Difference (Net)|0.22|||<|0.001|TWO_SIDED|95.0|0.17|0.27||A p-value of 0.05 was used as the threshold for statistical significance.|t-test, 2 sided|||||0.27|0.17|<0.001
71739774|NCT02508428|142992340|EQUIVALENCE|"Since the null hypothesis assumed that the incidences of clinically important osteolysis were not different, Equivalence has been specified for the Type of Statistical Test"|Risk Ratio (RR)|0.04|||<|0.001|TWO_SIDED|95.0|0.006|0.3||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||||0.30|0.006|<0.001
71739775|NCT02508428|142992341|EQUIVALENCE|"Since the null hypothesis assumed that the rate of satisfaction among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.48||||||A p-value of 0.05 was used as the threshold for statistical significance.|Fisher Exact|||Since there were no patients with Marathon liners who were unsatisfied with the outcome of their hip replacement, a relative risk and the associated confidence interval could not be calculated.||||0.48
71739776|NCT02508428|142992342|EQUIVALENCE|"Since the null hypothesis assumed that the Harris Hip Scores among the groups were not different, Equivalence has been specified for the Type of Statistical Test"||||||0.4||||||A p-value of 0.05 was used as the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||.40
71739777|NCT02178696|142992343|OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.31|<|0.001|TWO_SIDED|95.0|0.016|0.23||A p\<0.001 was established for regions a priori hypothesized (e.g. nucleus accumbens).|t-test, 2 sided|||||0.23|0.016|<0.001
71739778|NCT02748070|142992350|OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.819
71739779|NCT02748070|142992350|OTHER|||||||0.665|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.665
71739780|NCT02748070|142992350|OTHER|||||||0.071|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.071
71775115|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.88|TWO_SIDED|95.0|-0.83|0.18||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.18|-0.83|0.88
71775116|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.05||||1|TWO_SIDED|95.0|-0.53|0.44||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.44|-0.53|1.00
71845272|NCT05886777|143204385|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.05|||||TWO_SIDED|97.5|0.773|1.434|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.434|0.773|
71739781|NCT02748070|142992350|OTHER|||||||0.097|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.097
71739782|NCT02748070|142992351|OTHER|||||||0.376|||||||t-test, 2 sided|||Comparison of baseline and 1 week||||0.376
71661364|NCT02304991|142836405|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71739783|NCT02748070|142992351|OTHER|||||||0.685|||||||t-test, 2 sided|||Comparison of baseline and 1 month||||0.685
71739784|NCT02748070|142992351|OTHER|||||||0.388|||||||t-test, 2 sided|||Comparison of baseline and 3 months||||0.388
71739785|NCT02748070|142992351|OTHER|||||||0.233|||||||t-test, 2 sided|||Comparison of baseline and 6 months||||0.233
71739786|NCT00928694|142992372|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true geometric mean ratios (GMRs) \[U.S./UK\] for the AUC(0 to infinity) and maximum plasma concentration (Cmax) of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.96||||||90.0|0.9|1.02||||||||1.02|0.90|
71739787|NCT00928694|142992373|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true GMRs \[U.S./UK\] for the AUC(0 to infinity) and Cmax of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval \[0.80, 1.25\]).|Geometric Mean Ratio|0.98||||||90.0|0.9|1.06||||||||1.06|0.90|
71739788|NCT00534976|142992374|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.65||||0.02||95.0|||||ANOVA||Montelukast minus placebo|||||0.020
71739789|NCT00534976|142992375|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-4.33||||0.005||95.0|||||ANOVA||Montelukast minus placebo|||||0.005
71739790|NCT00534976|142992376|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-120.86||||0.022||95.0|||||ANOVA||Montelukast minus placebo|||||0.022
71739791|NCT00534976|142992377|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-122.82||||0.013||95.0|||||ANOVA||Montelukast minus placebo|||||0.013
71890529|NCT01955707|143302530|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|3.15||||0.989|TWO_SIDED|90.0|0.89|5.4||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 30. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||5.40|0.89|0.989
71739792|NCT00534976|142992378|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-8.27||||0.064||95.0|||||ANOVA||Montelukast minus placebo|||||0.064
71739793|NCT00534976|142992379|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-7.06||||0.054||95.0|||||ANOVA||Montelukast minus Placebo|||||0.054
71739794|NCT00534976|142992380|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-1.6||||1||95.0||||P-value provided is for comparison between the two proportions: Montelukast versus placebo.|McNemar||Montelukast minus placebo|||||1.000
71739795|NCT00534976|142992381|SUPERIORITY_OR_OTHER_LEGACY||Difference in Proportions|-3.2||||||95.0|||||||Montelukast minus placebo|||||
71739796|NCT02610777|142992400|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.464|TWO_SIDED|95.0|0.577|1.286||P-value is from an unstratified log-rank test.|Log Rank||Hazard Ratio (HR) was based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.286|0.577|0.464
71739797|NCT02610777|142992401|SUPERIORITY||Hazard Ratio (HR)|0.706|||=|0.092|TWO_SIDED|95.0|0.469|1.061||P-value comparing EFS between treatment groups was based on the unstratified log-rank test.|Log Rank||HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.|Event-Free Survival (EFS)||1.061|0.469|=0.092
71739798|NCT02610777|142992404|SUPERIORITY||Hazard Ratio (HR)|0.562|||=|0.267|TWO_SIDED|95.0|0.2|1.579||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.|||1.579|0.200|=0.267
71739799|NCT02610777|142992405|SUPERIORITY||Absolute Rate Difference|9.61|||=|0.312|TWO_SIDED|95.0|-8.83|28.04||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.04|-8.83|=0.312
71739800|NCT02610777|142992406|SUPERIORITY||Absolute Rate Difference|5.63||||0.56|TWO_SIDED|95.0|-13.19|24.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||24.44|-13.19|0.560
71739801|NCT02610777|142992407|SUPERIORITY||Absolute Rate Difference|8.64|||=|0.343|TWO_SIDED|95.0|-9.09|26.38||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||26.38|-9.09|=0.343
71739802|NCT02610777|142992408|SUPERIORITY||Absolute Rate Difference|-18.82|||=|0.296|TWO_SIDED|95.0|-52.91|15.26||P-value is from an unstratified Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||15.26|-52.91|=0.296
71739803|NCT02610777|142992409|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.152|TWO_SIDED|95.0|-4.49|30.81||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.81|-4.49|=0.152
71739804|NCT02610777|142992410|SUPERIORITY||Absolute Rate Difference|10.53|||=|0.301|TWO_SIDED|95.0|-9.13|30.18||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||30.18|-9.13|=0.301
71739805|NCT02610777|142992411|SUPERIORITY||Absolute Rate Difference|13.16|||=|0.254|TWO_SIDED|95.0|-9.12|35.44||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||35.44|-9.12|=0.254
71739806|NCT02610777|142992412|SUPERIORITY||Absolute Rate Difference|-4.71|||=|0.787|TWO_SIDED|95.0|-38.33|28.92||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel||Absolute difference \>0 represent better response achieved on pevonedistat combination compared to azacitidine treatment alone.|||28.92|-38.33|=0.787
71739807|NCT02610777|142992413|SUPERIORITY||Hazard Ratio (HR)|0.789|||=|0.62|TWO_SIDED|95.0|0.308|2.02||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||2.020|0.308|=0.620
71739808|NCT02610777|142992414|SUPERIORITY||Hazard Ratio (HR)|0.719|||=|0.436|TWO_SIDED|95.0|0.313|1.653||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.653|0.313|=0.436
71739809|NCT02610777|142992415|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.565|TWO_SIDED|95.0|0.395|1.662||P-value is from an unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||1.662|0.395|=0.565
71739810|NCT02610777|142992416|SUPERIORITY||Hazard Ratio (HR)|0.42|||=|0.383|TWO_SIDED|95.0|0.057|3.109||P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.|Log Rank||Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.|||3.109|0.057|=0.383
71739811|NCT02610777|142992417|SUPERIORITY||Hazard Ratio (HR)|1.206|||=|0.498|TWO_SIDED|95.0|0.699|2.081||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\>1 for the treatment indicates a shorter time to first CR, CRi or PR in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||2.081|0.699|=0.498
71739812|NCT02610777|142992418|SUPERIORITY||Hazard Ratio (HR)|0.905|||=|0.888|TWO_SIDED|95.0|0.226|3.62||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||3.620|0.226|=0.888
71775117|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.88|TWO_SIDED|95.0|-0.79|0.15||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.15|-0.79|0.88
71775118|NCT01920555|143050516|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.88|TWO_SIDED|95.0|-0.76|0.19||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||0.19|-0.76|0.88
71775119|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|11.18||||0.49|TWO_SIDED|95.0|-0.94|23.29||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||23.29|-0.94|0.49
71775120|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|1.37||||1|TWO_SIDED|95.0|-10.19|12.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||12.93|-10.19|1.00
71775121|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|16.54||||0.03|TWO_SIDED|95.0|5.31|27.77||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||27.77|5.31|0.03
71775122|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|8.68||||0.82|TWO_SIDED|95.0|-2.81|20.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.16|-2.81|0.82
71775123|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|5.11||||1|TWO_SIDED|95.0|-8.83|19.05||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||19.05|-8.83|1.00
71775124|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|-6.64||||1|TWO_SIDED|95.0|-19.87|6.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||6.59|-19.87|1.00
71775125|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|7.64||||1|TWO_SIDED|95.0|-5.26|20.53||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||20.53|-5.26|1.00
71775126|NCT01920555|143050517|SUPERIORITY||Mean Difference (Final Values)|4.8||||1|TWO_SIDED|95.0|-8.31|17.91||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||17.91|-8.31|1.00
71739813|NCT02610777|142992419|SUPERIORITY||Absolute Rate Difference|19.231|||=|0.162|TWO_SIDED|95.0|-6.925|45.386||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With RBCs-transfusion Independence||45.386|-6.925|=0.162
71739814|NCT02610777|142992419|SUPERIORITY||Absolute Rate Difference|20.0|||=|0.454|TWO_SIDED|95.0|-26.381|66.381||P-value is from an unstratified Cochran-Mantel Haenszel chi-square test.|Cochran-Mantel-Haenszel|||Percentage of Participants With Platelet-transfusion Independence||66.381|-26.381|=0.454
71833556|NCT04992390|143171814|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|0.8|||>|0.05|TWO_SIDED|95.0|0.6|1.07||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of days worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|1.07|0.60|>.05
71833557|NCT04992390|143171815|SUPERIORITY|Multilevel modelling (MLM) was performed with baseline measure, binary arm status, follow-up time and arm-by-time interaction included as fixed-effect covariates. Individual participant was also included as a level-two analytical unit, to quantify: (a) between-group treatment effect estimates and (b) within-group changes between each follow-up time for secondary outcome measures.|Incidence Rate Ratio|1.09|||<|0.05|TWO_SIDED|95.0|0.57|2.09||No multiplicity adjustments were applied as there was only one primary outcome, and secondary outcomes aimed to support the primary analyses. The a priori threshold for statistical significance was 0.05.|Regression, Multilevel Poisson|||ITT analysis for number of nights worked (treatment effects for between-arm comparisons) at week 4.|Please see Iyadurai et al., 2023 Supplementary Materials for within-subjects comparisons. (Iyadurai, et al. Transl Psychiatry 13, 290 (2023). https://doi.org/10.1038/s41398-023-02578-0)|2.09|0.57|<.05
71833558|NCT01303445|143171822|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.03||||||90.0|86.95|97.4||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||97.40|86.95|
71833559|NCT01303445|143171822|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.3||||||90.0|87.76|97.08||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||97.08|87.76|
71833560|NCT01303445|143171823|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|96.38||||||90.0|90.96|102.13||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||102.13|90.96|
71833561|NCT01303445|143171823|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|97.03||||||95.0|93.26|100.95||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||100.95|93.26|
71833562|NCT01303445|143171824|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.32|99.72||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.72|98.32|
71890530|NCT01955707|143302530|SUPERIORITY_OR_OTHER||adjusted mean change from baseline|1.93||||0.915|TWO_SIDED|90.0|-0.38|4.25||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 90. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.||4.25|-0.38|0.915
71676999|NCT01011465|142872278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.43||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.43
71739815|NCT02610777|142992421|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.266|TWO_SIDED|95.0|0.521|1.198||P-value is from an unstratified log-rank test.|Log Rank||HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to PD, Relapse, or Death in the Pevonedistat Combination arm compared to the Azacitidine only arm.|||1.198|0.521|=0.266
71739816|NCT00660179|142992462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.0108|TWO_SIDED|97.5|0.516|0.96|||Log Rank|||||0.960|0.516|0.0108
71833563|NCT01303445|143171824|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|98.42||||||90.0|97.66|99.18||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.18|97.66|
71833564|NCT01303445|143171825|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|105.55||||||90.0|97.09|114.74||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||114.74|97.09|
71833565|NCT01303445|143171825|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|106.09||||||90.0|98.64|114.09||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||114.09|98.64|
71833566|NCT01303445|143171826|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.38||||||90.0|98.8|99.95||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone||99.95|98.80|
71833567|NCT01303445|143171826|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.46|99.59||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone||99.59|98.46|
71890531|NCT01955707|143302531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.564|TWO_SIDED|90.0|0.55|1.45||One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 5. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.45|0.55|0.564
71890532|NCT01955707|143302531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.077|TWO_SIDED|90.0|0.8|2.1||One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 30. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||2.10|0.80|0.077
71661365|NCT01770392|142836448|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|50.12|STANDARD_DEVIATION|12.7||1|TWO_SIDED|90.0|47.155|53.275||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)"|||53.275|47.155|1.0000
71661366|NCT01770392|142836449|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|59.76|STANDARD_DEVIATION|21.9||1|TWO_SIDED|90.0|53.829|66.348||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||66.348|53.829|1.0000
71661367|NCT01770392|142836450|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|49.98|STANDARD_DEVIATION|13.3||1|TWO_SIDED|90.0|46.886|53.286||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."|||53.286|46.886|1.0000
71739817|NCT00660179|142992462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.547|||<|0.0001|TWO_SIDED|97.5|0.392|0.762|||Log Rank|||||0.762|0.392|<0.0001
71833568|NCT04994509|143171835|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||Confidence Interval (CI) for rate ratio vs bHIV is from a likelihood-based method.|Null Hypothesis 01: LEN/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly lower than bHIV.||0.042|0.000|<0.0001
71833569|NCT04994509|143171835|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.042||p-value for rate ratio vs bHIV is from likelihood ratio test.|Likelihood ratio test||CI for rate ratio vs bHIV is based on a likelihood-based method.|Null Hypothesis 02: LEN/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in LEN was significantly and at least 20% lower than bHIV.||0.042|0.000|<0.0001
71661368|NCT00390221|142836465|SUPERIORITY_OR_OTHER||Rate Ratio|0.461|||<|0.0001|TWO_SIDED|95.0|0.318|0.668||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.668|0.318|<0.0001
71661369|NCT00390221|142836465|SUPERIORITY_OR_OTHER||Rate Ratio|0.503||||0.0002|TWO_SIDED|95.0|0.352|0.721||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (\<=2.5 vs \> 2.5), and age (\<=35 vs \>35)|Negative Binomial Regression|||||0.721|0.352|0.0002
71661370|NCT00390221|142836466|SUPERIORITY_OR_OTHER||Percent Reduction|78.44|||<|0.0001|TWO_SIDED|95.0|65.97|86.35|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||86.35|65.97|<0.0001
71661371|NCT00390221|142836466|SUPERIORITY_OR_OTHER||Percent Reduction|69.47|||<|0.0001|TWO_SIDED|95.0|52.4|80.41|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||80.41|52.40|<0.0001
71677000|NCT01011465|142872278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.08||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.08
71739818|NCT00660179|142992463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.669||||0.0146|TWO_SIDED|97.5|0.462|0.97|||Log Rank|||||0.970|0.462|0.0146
71739819|NCT00660179|142992463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|97.5|0.335|0.747|||Log Rank|||||0.747|0.335|<0.0001
71739820|NCT00660179|142992464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.9249|TWO_SIDED|97.5|0.477|1.976|||Log Rank|||||1.976|0.477|0.9249
71739821|NCT00660179|142992464|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.638||||0.2037|TWO_SIDED|97.5|0.287|1.418|||Log Rank|||||1.418|0.287|0.2037
71739822|NCT00660179|142992465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.8312|TWO_SIDED|97.5|0.653|1.673|||Log Rank|||||1.673|0.653|0.8312
71833570|NCT04994509|143171835|SUPERIORITY||Rate Ratio|0.839||||0.20697|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 03: F/TAF/bHIV\>= 1; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly lower than bHIV.||1.279|0.550|0.20697
71661372|NCT00390221|142836467|SUPERIORITY_OR_OTHER||Percent Reduction|78.73|||<|0.0001|TWO_SIDED|95.0|71.33|84.22|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||84.22|71.33|<0.0001
71661373|NCT00390221|142836467|SUPERIORITY_OR_OTHER||Percent Reduction|70.23|||<|0.0001|TWO_SIDED|95.0|59.94|77.88|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||77.88|59.94|<0.0001
71661374|NCT00390221|142836468|SUPERIORITY_OR_OTHER||Hazard Ratio|0.49||||0.0003|TWO_SIDED|95.0|0.33|0.72||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.72|0.33|0.0003
71739823|NCT00660179|142992465|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.771||||0.2509|TWO_SIDED|97.5|0.464|1.282|||Log Rank|||||1.282|0.464|0.2509
71739824|NCT04808141|142992481|EQUIVALENCE|For a power of 80% and a two-sided 0.05 significance level, we calculated that 102 individuals would be necessary to detect a 10-point difference between the two groups. To guarantee that the study was adequately powered to detect equivalence, a posteriori analysis was conducted using the Two One-Sided Test (TOST) methodology (simulation-based power analysis).|Median Difference (Net)|-0.55||||0.412|TWO_SIDED|95.0|-2.42|5.81||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||5.81|-2.42|0.412
71739825|NCT04808141|142992481|EQUIVALENCE||Odds Ratio (OR)|0.926||||0.849|TWO_SIDED|95.0|0.42|2.05||The threshold for statistical analysis was set at 0.05.|Regression, Logistic|||||2.05|0.42|0.849
71739826|NCT04808141|142992482|EQUIVALENCE||Median Difference (Net)|0.3||||0.666|TWO_SIDED|95.0|-0.71|1.1||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|robust method on the medians||||1.10|-0.71|0.666
71739827|NCT04808141|142992483|EQUIVALENCE||Median Difference (Net)|-2.62||||0.122|TWO_SIDED|95.0|-14.87|4.8||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust test on the medians||||4.80|-14.87|0.122
71739828|NCT04808141|142992484|EQUIVALENCE||Median Difference (Net)|3.32||||0.788|TWO_SIDED|95.0|-3.11|5.9||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||5.90|-3.11|0.788
71739829|NCT04808141|142992485|EQUIVALENCE||Odds Ratio (OR)|0.92||||0.081|TWO_SIDED|95.0|0.0|1.23||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming analgesics at 8 weeks using the CG as a reference.||||1.23|0.00|0.081
71739830|NCT04808141|142992485|EQUIVALENCE||Odds Ratio (OR)|0.26||||0.985|TWO_SIDED|95.0|0.0|1.71||The threshold for statistical significance was set at 0.05.|Regression, Logistic|LR to assess the odds between groups for consuming opioids at 8 weeks using the CG as a reference.||||1.71|0.00|0.985
71739831|NCT04808141|142992486|EQUIVALENCE||Median Difference (Net)|-0.42||||0.871|TWO_SIDED|95.0|-2.1|1.78||the threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.78|-2.10|0.871
71739832|NCT04808141|142992487|EQUIVALENCE||Median Difference (Final Values)|0.43||||0.36|TWO_SIDED|95.0|-0.59|1.59||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||1.59|-0.59|0.360
71739833|NCT04808141|142992488|EQUIVALENCE||Mean Difference (Final Values)|0.09||||0.837|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||0.837
71739834|NCT04808141|142992489|EQUIVALENCE||Z-score|-1.28||||0.886|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Ordinal Regression|||||||0.886
71739835|NCT04808141|142992490|EQUIVALENCE||Median Difference (Net)|1.33||||0.095|TWO_SIDED|95.0|-2.2|2.46||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||2.46|-2.20|0.095
71739836|NCT04808141|142992492|EQUIVALENCE||Mean Difference (Final Values)|65.8||||0.662|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.662
71739837|NCT04808141|142992493|EQUIVALENCE||Median Difference (Net)|-1.97||||0.246|TWO_SIDED|95.0|-12.69|3.33|||Quantile mixed-effects model|Robust method on the medians||||3.33|-12.69|0.246
71739838|NCT04808141|142992494|EQUIVALENCE||Median Difference (Net)|-0.73||||0.408|TWO_SIDED|95.0|-6.5|2.69||the threshold for statistical significance was set at 0.05|Quantile mixed-effects model|Robust method on the medians.||||2.69|-6.50|0.408
71739839|NCT04808141|142992495|EQUIVALENCE||Median Difference (Net)|0.35||||0.65|TWO_SIDED|95.0|-6.22|9.87||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|Robust method on the medians||||9.87|-6.22|0.650
71739840|NCT04808141|142992496|EQUIVALENCE||Difference in proportions|18.6||||0.019|TWO_SIDED||||||Chi-squared|||||||0.019
71739841|NCT05292131|142992587|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC.|Geometric Mean Ratio (percentage [%])|97.5|||||TWO_SIDED|90.0|90.2|105.4||||||||105.40|90.20|
71739842|NCT05292131|142992588|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for AUC0-t.|Geometric Mean Ratio (%)|97.05|||||TWO_SIDED|90.0|90.1|104.55||||||||104.55|90.10|
71739843|NCT05292131|142992589|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for Cmax.|Geometric Mean Ratio (%)|96.21|||||TWO_SIDED|90.0|88.6|104.47||||||||104.47|88.60|
71739844|NCT05292131|142992592|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 0.8 to 1.25 for t½.|Geometric Mean Ratio (%)|101.13|||||TWO_SIDED|90.0|94.18|108.59||||||||108.59|94.18|
71739845|NCT05292131|142992593|EQUIVALENCE|The point estimate and the 90% CI for the median treatment differences for tmax was computed according to the Hodges-Lehmann's method.|Hodges-Lehman Estimate|0.4897|||||TWO_SIDED|90.0|-0.0073|0.9567||||||||0.9567|-0.0073|
71739846|NCT01979952|142992624|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.176|STANDARD_ERROR_OF_MEAN|6.237|||TWO_SIDED|95.0|-9.227|15.579|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.579|-9.227|
71739847|NCT01979952|142992625|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.519|STANDARD_ERROR_OF_MEAN|6.3829|||TWO_SIDED|95.0|-10.258|15.296|||ANCOVA|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate||15.296|-10.258|
71739848|NCT01979952|142992626|SUPERIORITY_OR_OTHER||Adjusted mean difference|69.0|STANDARD_ERROR_OF_MEAN|39.182|||TWO_SIDED|95.0|-8.74|146.75|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||146.75|-8.74|
71739849|NCT01979952|142992627|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.36|||||TWO_SIDED|95.0|-0.29|5.0|||Mixed Models Analysis|As per the Clinical Trial Protocol, this is an exploratory trial hence p-values were not calculated.||MMRM model with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix.||5.00|-0.29|
71739850|NCT01979952|142992629|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.05|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|95.0|-4.89|4.79|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||4.79|-4.89|
71739851|NCT01979952|142992630|SUPERIORITY_OR_OTHER||Adjusted mean difference|17.94|STANDARD_ERROR_OF_MEAN|16.19|||TWO_SIDED|95.0|-14.21|50.09|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||50.09|-14.21|
71739852|NCT01979952|142992631|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.89|||||TWO_SIDED|95.0|-1.47|11.25|||Mixed Models Analysis|||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation||11.25|-1.47|
71739853|NCT05438576|142992636|SUPERIORITY||Odds Ratio (OR)|2.12||||0.032|TWO_SIDED|95.0|1.05|4.27|||Regression, Logistic|||||4.27|1.05|0.032
71739854|NCT05438576|142992641|SUPERIORITY||Odds Ratio (OR)|1.1||||0.621|TWO_SIDED|95.0|0.74|1.64|||Regression, Logistic|||||1.64|0.74|0.621
71775127|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|-1.21||||1|TWO_SIDED|95.0|-3.99|1.56||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.56|-3.99|1.00
71677001|NCT01011465|142872278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.25||95.0|||||ANOVA|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.||||0.25
71677002|NCT01011465|142872279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.83||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.83
71739855|NCT00465088|142992655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05|Mixed Models Analysis|||An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide \> 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%||||<0.001
71739856|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.053||||0.04|TWO_SIDED|95.0|0.003|0.104||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.104|0.003|0.040
71739857|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.103|||<|0.001|TWO_SIDED|95.0|0.052|0.153|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.153|0.052|<0.001
71775128|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.17|TWO_SIDED|95.0|-1.9|3.43||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||3.43|-1.90|0.17
71739858|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.192|||<|0.001|TWO_SIDED|95.0|0.141|0.243||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.243|0.141|<0.001
71739859|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.173|||<|0.001|TWO_SIDED|95.0|0.123|0.224|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.224|0.123|<0.001
71775129|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|-2.74||||0.3|TWO_SIDED|95.0|-5.32|-0.16||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||-0.16|-5.32|0.30
71775130|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|-0.71||||1|TWO_SIDED|95.0|-3.35|1.93||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.93|-3.35|1.00
71775131|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|-0.29||||1|TWO_SIDED|95.0|-3.25|2.66||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.66|-3.25|1.00
71775132|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|2.76||||0.39|TWO_SIDED|95.0|-0.06|5.59||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||5.59|-0.06|0.39
71775133|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|-1.17||||1|TWO_SIDED|95.0|-3.91|1.58||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||1.58|-3.91|1.00
71775134|NCT01920555|143050518|SUPERIORITY||Mean Difference (Final Values)|-0.43||||1|TWO_SIDED|95.0|-3.22|2.35||Holm's method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY\*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm's method to protect family-wise error rate in the presence of multiple testing."||2.35|-3.22|1.00
71775135|NCT01193660|143050544|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.59|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71775136|NCT01193660|143050545|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|3.94|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71775137|NCT01193660|143050546|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|2.7|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71775138|NCT01193660|143050548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||The baseline and post-therapy data of each group were compared using paired t-test statistics.|t-test, 2 sided|Voxels with an uncorrected p-value of \<0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.||In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.||||0.05
71833571|NCT04994509|143171835|SUPERIORITY||Rate Ratio|0.839||||0.58674|TWO_SIDED|95.0|0.55|1.279||p-value for rate ratio vs bHIV is from Wald test.|Wald test||CI for rate ratio vs bHIV is based on the delta method.|Null Hypothesis 04: F/TAF/bHIV\>= 0.8; Null hypothesis was to be rejected if HIV-1 incidence in F/TAF was significantly and at least 20% lower than bHIV.||1.279|0.550|0.58674
71890533|NCT01955707|143302531|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.243|TWO_SIDED|90.0|0.71|1.86||One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of the distribution of mRS scores at Day 90. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (\< median vs \>= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).||1.86|0.71|0.243
71890534|NCT01955707|143302532|SUPERIORITY_OR_OTHER||Adjusted mean|0.68||||0.455|TWO_SIDED|90.0|-9.19|10.56||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 5. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||10.56|-9.19|0.455
71890535|NCT01955707|143302532|SUPERIORITY_OR_OTHER||Adjusted mean|1.21||||0.42|TWO_SIDED|90.0|-8.76|11.19||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 30. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||11.19|-8.76|0.420
71890536|NCT01955707|143302532|SUPERIORITY_OR_OTHER||Adjusted mean|3.56||||0.283|TWO_SIDED|90.0|-6.64|13.75|||repeated measures mixed effects model|||Analysis of Barthel Index at Day 90/Final Visit. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.||13.75|-6.64|0.283
71890537|NCT01817790|143302543|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.36||||0.0024|TWO_SIDED|95.0|-0.59|-0.13||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.13|-0.59|0.0024
71890538|NCT01817790|143302544|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.33||||0.0057|TWO_SIDED|95.0|-0.56|-0.1||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.10|-0.56|0.0057
71890539|NCT01817790|143302545|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.41||||0.0009||95.0|-0.65|-0.17||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.17|-0.65|0.0009
71890540|NCT01817790|143302546|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0117|TWO_SIDED|95.0|-0.19|-0.02||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.02|-0.19|0.0117
71890541|NCT01817790|143302547|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.15||||0.0005||95.0|-0.23|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.23|0.0005
71890542|NCT01817790|143302548|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.13||||0.0023||95.0|-0.22|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.22|0.0023
71813045|NCT00514683|143128438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19||||0.0379|TWO_SIDED|95.0|0.04|0.911|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||0.911|0.040|0.0379
71890543|NCT01817790|143302549|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.18|||<|0.0001||95.0|-0.26|-0.09||p-value was nor adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.||-0.09|-0.26|<0.0001
71890544|NCT01817790|143302550|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0304||95.0|-0.18|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.18|0.0304
71890545|NCT01817790|143302551|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.0361||95.0|-0.19|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.||-0.01|-0.19|0.0361
71890546|NCT01817790|143302552|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.28||||0.0129|TWO_SIDED|95.0|-0.5|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.06|-0.50|0.0129
71677003|NCT01011465|142872279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.56||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.56
71677004|NCT01011465|142872279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.95||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.||||0.95
71833572|NCT04994509|143171836|SUPERIORITY||Rate Ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.101||p-value for rate ratio vs F/TDF is from an exact conditional Poisson model.|Poisson model||CI is from an exact conditional Poisson model.|||0.101|0.000|< 0.0001
71833573|NCT04994509|143171836|SUPERIORITY||Rate Ratio|1.198||||0.7282|TWO_SIDED|95.0|0.669|2.143||p-value for rate ratio vs F/TDF is from a Poisson model.|Poisson model||CI is from a Poisson model.|||2.143|0.669|0.72820
71833574|NCT04994509|143171836|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the LEN group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|-1.685|||<|0.0001|TWO_SIDED|95.0|-2.737|-0.939||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||-0.939|-2.737|<0.0001
71833575|NCT04994509|143171836|OTHER|Comparability to F/TDF is defined as the HIV-1 incidence in the F/TAF group at most 0.8/100 PY higher than in the F/TDF group.|Rate Difference|0.333||||0.209|TWO_SIDED|95.0|-0.869|1.367||p-value for rate difference vs F/TDF is based on a hybrid approach.|Hybrid approach||Exact CI is based on a hybrid approach.|||1.367|-0.869|0.20900
71833576|NCT04994509|143171838|SUPERIORITY||Exact Odds Ratio|9.0||||0.0006|TWO_SIDED|95.0|2.06|83.36||p-value is from exact conditional logistic regression model.|ExactConditionalLogisticRegressionModel||Exact odds ratio and and CI are from exact conditional logistic regression model.|||83.36|2.06|0.0006
71890547|NCT01817790|143302553|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.14||||0.0002|TWO_SIDED|95.0|-0.22|-0.07||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.||-0.07|-0.22|0.0002
71890548|NCT01817790|143302554|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||p-value was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Using this test controlling for investigative site. The response variable lied on ordinal scale of measurement.||Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.||||0.0118
71890549|NCT01817790|143302555|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.01||||0.8586|TWO_SIDED|95.0|-0.12|0.1|||ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.||0.10|-0.12|0.8586
71890550|NCT01817790|143302556|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.29||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.||-0.29|-0.65|<0.0001
71890551|NCT01817790|143302557|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.3||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray||-0.30|-0.68|<0.0001
71890552|NCT01817790|143302558|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.24||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.24|-0.64|<0.0001
71890553|NCT01817790|143302559|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.33||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.33|-0.73|<0.0001
71890554|NCT01817790|143302560|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.44|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.23||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.23|-0.65|<0.0001
71833577|NCT02576509|143171844|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0752|TWO_SIDED|95.0|0.71|1.02||A priori threshold for statistical significance is 0.0419|Log Rank|Log-rank Test stratified by the stratification factors as entered into the IVRS|Nivolumab over Sorafenib; Stratified Cox proportional hazard model||95.81% CI ADJUSTED FOR MULTIPLICITY: (0.72 to 1.02)|1.02|0.71|0.0752
71833578|NCT02576509|143171845|OTHER|no test was performed due to OS p-value result above the prior threshold|Difference of ORRs|8.3|||||TWO_SIDED|95.0|3.9|12.7|||||Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors|||12.7|3.9|
71833579|NCT02576509|143171845|OTHER|no test was performed due to OS p-value result above the prior threshold|Odds Ratio (OR)|2.41|||||TWO_SIDED|95.0|1.48|3.92|||||Nivolumab over Sorafenib; Mantel-Haenszel estimator|||3.92|1.48|
71833580|NCT02576509|143171846|OTHER|no test was performed due to OS p-value result above the prior threshold|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1|||||Nivolumab over Sorafenib; Stratified Cox proportional hazard model|||1.10|0.79|
71833581|NCT02576509|143171847|OTHER|PD-L1 \>= 1%, OS; no test was performed|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Nivolumab over Sorafenib|||1.19|0.54|
71833582|NCT02576509|143171847|OTHER|PD-L1 \>=1%, PFS; no test was performed|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||||Nivolumab over Sorafenib|||1.03|0.48|
71833583|NCT02576509|143171847|OTHER|PD-L1 \<1%, OS; no test was performed|Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.02|||||Nivolumab over Sorafenib|||1.02|0.69|
71833584|NCT02576509|143171847|OTHER|PD-L1 \<1%, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.81|1.17|||||Nivolumab over Sorafenib|||1.17|0.81|
71833585|NCT02576509|143171847|OTHER|without PD-L1 quantifiable, OS; no test was performed|Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.34|4.74|||||Nivolumab over Sorafenib|||4.74|0.34|
71833586|NCT02576509|143171847|OTHER|without PD-L1 quantifiable, PFS; no test was performed|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.27|3.52|||||Nivolumab over Sorafenib|||3.52|0.27|
71890555|NCT01817790|143302561|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.64|-0.21||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.||-0.21|-0.64|<0.0001
71775139|NCT01193660|143050550|SUPERIORITY_OR_OTHER_LEGACY||interaction of group and visit|0.9|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71677371|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.78|||||TWO_SIDED|95.0|0.588|1.003||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.003|0.588|
71775140|NCT01193660|143050551|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|1.279|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71890556|NCT04533711|143302671|SUPERIORITY||Mean Difference (Final Values)|8.35||||0.3086|TWO_SIDED|95.0|-7.68|24.38|||Mixed Models Analysis|||||24.38|-7.68|0.3086
71890557|NCT04533711|143302672|SUPERIORITY||Mean Difference (Final Values)|10.93||||0.182|TWO_SIDED|95.0|-5.06|26.92|||Mixed Models Analysis|||||26.92|-5.06|0.1820
71739860|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.17|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.170|0.070|<0.001
71739861|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.09|||<|0.001|TWO_SIDED|95.0|0.039|0.14||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.140|0.039|<0.001
71739862|NCT01053988|142992680|SUPERIORITY_OR_OTHER||Least squares mean difference|0.071||||0.006|TWO_SIDED|95.0|0.021|0.121||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.021|0.006
71739863|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.033||||0.241|TWO_SIDED|95.0|-0.022|0.088|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.088|-0.022|0.241
71739864|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.067||||0.017|TWO_SIDED|95.0|0.012|0.121|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.121|0.012|0.017
71739865|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.129|||<|0.001|TWO_SIDED|95.0|0.074|0.184||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.184|0.074|<0.001
71739866|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.06|0.169|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.169|0.060|<0.001
71739867|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.003|TWO_SIDED|95.0|0.028|0.136||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.136|0.028|0.003
71775141|NCT01193660|143050552|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.996|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71890558|NCT04533711|143302673|SUPERIORITY||Mean Difference (Final Values)|308.4||||0.094|TWO_SIDED|95.0|-50.2|667.1|||Mixed Models Analysis|||||667.1|-50.2|0.094
71739868|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.062||||0.025|TWO_SIDED|95.0|0.008|0.117||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.117|0.008|0.025
71890559|NCT04533711|143302674|SUPERIORITY||Mean Difference (Final Values)|352.0||||0.0691|TWO_SIDED|95.0|-25.2|729.2|||Mixed Models Analysis|||||729.2|-25.2|0.0691
71739869|NCT01053988|142992681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.102|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.102|-0.006|0.082
71739870|NCT05723263|142992722|OTHER||Proportional difference|91.0|||<|0.01|TWO_SIDED|95.0|90.2|91.8||The threshold for statistical significance was p\<0.05.|Generalized Estimating Equations|||It was calculated that 12 clinic sites with 1200 participants randomized in a 1:1:1 ratio between the three arms, would have at least 90% power to detect a 10% difference in the proportion of test uptake between the pay-it-forward and control group participants, using a two-sided, two-sample t-test (α=0.05), assuming a 0.25\~0.31 cluster coefficient of variation, \<5% lost-to-follow-up rate, and an intra-class correlation of 0.016.||91.8|90.2|<0.01
71739871|NCT05723263|142992723|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71739872|NCT05723263|142992724|OTHER|||||||0.0059|||||||Chi-squared|||||||0.0059
71739873|NCT05723263|142992725|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71739874|NCT05723263|142992727|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71739875|NCT05723263|142992728|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
71739876|NCT05723263|142992729|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71739877|NCT05723263|142992730|OTHER|||||||0.727|||||||t-test, 2 sided|||||||0.727
71890560|NCT04533711|143302675|SUPERIORITY||Mean Difference (Final Values)|-5.85||||0.4953|TWO_SIDED|95.0|-22.6|10.94|||Mixed Models Analysis|||||10.94|-22.6|0.4953
71833587|NCT02576509|143171848|OTHER|PD-L1 \>=1%, ORR; no test was performed|Odds Ratio (OR)|3.79|||||TWO_SIDED|95.0|1.41|10.17|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.|||10.17|1.41|
71833588|NCT02576509|143171848|OTHER|PD-L1 \<1%, ORR; no test was performed|Odds Ratio (OR)|1.95|||||TWO_SIDED|95.0|1.1|3.45|||||Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI|||3.45|1.10|
71833589|NCT06546657|143171856|OTHER||Mean Difference (Final Values)|1.74||||0.14|TWO_SIDED|95.0|-0.6|4.0||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||Medium GI vs low GI breakfast meals||4.0|-0.6|0.14
71833590|NCT06546657|143171856|OTHER||Mean Difference (Final Values)|4.4||||0.01|TWO_SIDED|95.0|1.2|7.5|||Linear Mixed Model|||Medium vs high GI breakfast meals||7.5|1.2|0.01
71833591|NCT06546657|143171856|OTHER||Mean Difference (Final Values)|-2.63||||0.12|TWO_SIDED|95.0|-6.0|0.7||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||High GI vs low GI breakfast meals||0.7|-6.0|0.12
71833592|NCT06546657|143171857|OTHER||Mean Difference (Final Values)|0.1815||||0.65|TWO_SIDED||||||Linear Mixed Model|||High GI breakfast meals vs low and medium GI breakfast meals||||0.65
71833593|NCT06546657|143171858|OTHER||Mean Difference (Final Values)|0.431||||0.25|TWO_SIDED|95.0|-0.3|1.2|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||1.2|-0.3|0.25
71833594|NCT06546657|143171859|OTHER||Mean Difference (Final Values)|22.0||||0.04|TWO_SIDED|95.0|0.6|44.0|||Linear Mixed Model|||High glycaemic load breakfast meals vs low and medium glycaemic load meals||44|0.6|0.04
71833595|NCT06546657|143171860|OTHER||Mean Difference (Final Values)|1.3||||0.01|TWO_SIDED|95.0|0.4|2.1|||Linear Mixed Model|||Breakfast cereals meals vs added protein meals||2.1|0.4|0.01
71739878|NCT04765202|142992738|SUPERIORITY||Percentage Difference|14.3||||1|TWO_SIDED|95.0|-11.64|40.21|||Fisher Exact||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 1.||40.21|-11.64|1.0000
71833596|NCT06546657|143171862|OTHER|Comparison of diurnal and nocturnal glucose variability (CV%)|Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71833597|NCT05505045|143171868|OTHER||Cohen's d effect size|0.44|||||TWO_SIDED|95.0|-0.16|1.05||||||||1.05|-.16|
71833598|NCT05505045|143171869|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.19|1.03||||||||1.03|-.19|
71833599|NCT05505045|143171870|OTHER||Cohen's d effect size|0.31|||||TWO_SIDED|95.0|-0.3|0.93||||||||0.93|-.30|
71833600|NCT05505045|143171871|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|96.0|-1.04|0.21||||||||0.21|-1.04|
71833601|NCT05505045|143171876|OTHER||Cohen's d effect size|0.01|||||TWO_SIDED|95.0|-0.61|0.64||||||||.64|-.61|
71833602|NCT01643070|143171877|SUPERIORITY||Odds Ratio (OR)|1.5||||0.719|TWO_SIDED|95.0|0.346|6.501|||t-test, 1 sided|||||6.501|0.346|0.719
71833603|NCT05540535|143171888|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
71833604|NCT05540535|143171889|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71833605|NCT05540535|143171890|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|The Wilcoxon signed-rank test was used for a within-group comparison.||||||<0.05
71833606|NCT05540535|143171891|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71833607|NCT05540535|143171892|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
71833608|NCT05540535|143171893|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
71833609|NCT05540535|143171894|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
71833610|NCT03089125|143171895|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.038|TWO_SIDED|95.0|-0.61|-0.05||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||-0.05|-0.61|0.038
71833611|NCT03089125|143171896|SUPERIORITY||Mean Difference (Final Values)|-0.55|||>|0.99|TWO_SIDED|95.0|-2.2|1.1||Bonferroni-adjusted P-value|ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||1.10|-2.20|>0.99
71833612|NCT03089125|143171897|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.38|TWO_SIDED|95.0|-1.98|5.18|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||5.18|-1.98|0.380
71833613|NCT03089125|143171898|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.99|TWO_SIDED|95.0|-0.83|0.82|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||0.82|-0.83|0.990
71833614|NCT03089125|143171899|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.251|TWO_SIDED|95.0|-1.34|0.35|||ANCOVA|||||0.35|-1.34|0.251
71833615|NCT03089125|143171900|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.647|TWO_SIDED|95.0|-7.9|4.92|||ANCOVA|ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.||||4.92|-7.90|0.647
71833616|NCT03089125|143171901|SUPERIORITY||Mean Difference (Final Values)|1.63||||0.431|TWO_SIDED|95.0|-2.45|5.71||ANCOVA models control for cancer type, study site, and baseline scores of outcome variable.|ANCOVA|||||5.71|-2.45|0.431
71833617|NCT03089125|143171902|SUPERIORITY||Between-group diff in change per 8 weeks|-0.06||||0.71|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.26|-0.38|0.710
71833618|NCT03089125|143171903|SUPERIORITY||Between-group diff in change per 8 weeks|0.38||||0.677|TWO_SIDED|95.0|-1.4|2.16|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||2.16|-1.40|0.677
71833619|NCT03089125|143171904|SUPERIORITY||Between-group diff in change per 8 weeks|-1.95||||0.33|TWO_SIDED|95.0|-5.87|1.97|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.97|-5.87|0.330
71833620|NCT03089125|143171905|SUPERIORITY||Between-group diff in change per 8 weeks|0.73||||0.098|TWO_SIDED|95.0|-0.13|1.59|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||1.59|-0.13|0.098
71890561|NCT04533711|143302676|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.8041|TWO_SIDED|95.0|-20.0|15.49|||Mixed Models Analysis|||||15.49|-20.0|0.8041
71890562|NCT04533711|143302677|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.9645|TWO_SIDED|95.0|-2.86|2.99|||Mixed Models Analysis|||||2.99|-2.86|0.9645
71890563|NCT04533711|143302678|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0989|TWO_SIDED|95.0|-5.85|0.49|||Mixed Models Analysis|||||0.49|-5.85|0.0989
71890564|NCT04533711|143302679|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7667|TWO_SIDED|95.0|-0.77|1.05|||Mixed Models Analysis|||||1.05|-0.77|0.7667
71890565|NCT04533711|143302680|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0894|TWO_SIDED|95.0|-1.87|0.13|||Mixed Models Analysis|||||0.13|-1.87|0.0894
71890566|NCT03783195|143302690|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.59||0.4|TWO_SIDED|95.0|-1.77|0.76||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||0.76|-1.77|0.40
71890567|NCT03783195|143302691|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.93||0.71|TWO_SIDED|95.0|-3.33|2.57||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in liver fat as compared to high GRS group.||2.57|-3.33|0.71
71890568|NCT03783195|143302692|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.02|STANDARD_ERROR_OF_MEAN|4.8||0.0006|TWO_SIDED|95.0|-31.33|-10.72||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in VLDL-TG as compared to high GRS group.||-10.72|-31.33|0.0006
71890569|NCT03783195|143302693|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Median Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.17||0.59|TWO_SIDED|95.0|-0.27|0.46|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements at different time points between the two GRS groups.||0.46|-0.27|0.59
71890570|NCT03783195|143302694|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.06|STANDARD_ERROR_OF_MEAN|7.77||0.017|TWO_SIDED|95.0|-37.75|-4.38||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum triglycerides as compared to high GRS group.||-4.38|-37.75|0.017
71890571|NCT03783195|143302695|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.16||0.89|TWO_SIDED|95.0|-0.37|0.33|||t-test, 2 sided|||This analysis focuses on the changes in the area under the curve (AUC) for measurements baseline and 3hr timepoints at week 0 and week 3 between the two GRS groups.||0.33|-0.37|0.89
71890572|NCT03783195|143302696|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|4.62||0.36|TWO_SIDED|95.0|-14.28|5.55||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have less increase in HDL cholesterol as compared to high GRS group.||5.55|-14.28|0.36
71890573|NCT03783195|143302697|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.16||0.67|TWO_SIDED|95.0|-0.27|0.4|||t-test, 2 sided|||||0.40|-0.27|0.67
71661375|NCT00390221|142836468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.3|0.67||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (\<=2.5 versus \>2.5, p=0.449), and age (\<=35 versus \>35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.67|0.30|<0.0001
71890574|NCT03783195|143302698|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-21.03|STANDARD_ERROR_OF_MEAN|11.53||0.09|TWO_SIDED|95.0|-45.76|3.69||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in LDL cholesterol as compared to high GRS group.||3.69|-45.76|0.09
71890575|NCT03783195|143302699|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.13||0.69|TWO_SIDED|95.0|-0.24|0.34|||t-test, 2 sided|||||0.34|-0.24|0.69
71890576|NCT03783195|143302700|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-29.61|STANDARD_ERROR_OF_MEAN|15.28||0.07|TWO_SIDED|95.0|-62.39|3.17||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in total cholesterol as compared to high GRS group.||3.17|-62.39|0.07
71890577|NCT03783195|143302701|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.80
71890578|NCT03783195|143302702|OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.25||0.17|TWO_SIDED|95.0|-0.18|0.91||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum uric acid as compared to high GRS group.||0.91|-0.18|0.17
71890579|NCT03783195|143302703|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.217|STANDARD_ERROR_OF_MEAN|0.17||0.22|TWO_SIDED|95.0|-0.58|0.15|||t-test, 2 sided|||||0.15|-0.58|0.22
71890580|NCT03783195|143302704|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.007||0.04|TWO_SIDED|95.0|-0.03|-0.0009||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALT as compared to high GRS group.||-0.0009|-0.03|0.04
71890581|NCT03783195|143302705|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.19||0.53|TWO_SIDED|95.0|-0.52|0.28|||t-test, 2 sided|||||0.28|-0.52|0.53
71661376|NCT00390221|142836469|SUPERIORITY_OR_OTHER||Relative Mean Change|-1.93||||0.1284|TWO_SIDED|95.0|-4.42|0.56||Analysis of variance for difference between treatment groups, controlling for baseline score.|Analysis of Variance|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||0.56|-4.42|0.1284
71661377|NCT00390221|142836469|SUPERIORITY_OR_OTHER||Relative Mean Change|-4.27||||0.0008|TWO_SIDED|95.0|-6.76|-1.78|||Analysis of Variance|Analysis of variance for difference between treatment groups, controlling for baseline score.||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.||-1.78|-6.76|0.0008
71739879|NCT04765202|142992738|SUPERIORITY||Percentage Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Difference was calculated as (percent area of wound closure in SOMA Tx site) - ((percent area of wound closure in AG Tx site). 95% CI was derived using the normal approximation to binomial distribution.|Comparison of complete wound closure without additional autografting at Month 2 in AG TX site and SOMA TX site in Cohort 1 Group 2.||0|0|
71833621|NCT03089125|143171906|SUPERIORITY||Between-group diff in change per 8 weeks|0.08||||0.845|TWO_SIDED|95.0|-0.76|0.93|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||0.93|-0.76|0.845
71739880|NCT03375489|142992746|EQUIVALENCE|Equivalence was established for patient-reported quality of life if the 90% confidence interval for the estimated difference in means was within the margin of ±4 points on the Functional Assessment of Cancer Therapy - Lung Questionnaire.|Mean Difference (Final Values)|2.0||||0.04|TWO_SIDED|90.0|0.1|3.9||The a priori threshold for statistical significance was p\<0.05.|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment and controlling for baseline Functional Assessment of Cancer Therapy - Lung Questionnaire scores.||3.9|0.1|0.04
71739881|NCT03375489|142992747|EQUIVALENCE|Equivalence was established for patient-reported communication with their clinicians about their end-of-life care preferences if the 90% confidence interval for the estimated difference in proportions was within the margin of ±8%.|Estimated Difference in Proportions|3.1||||0.26|TWO_SIDED|90.0|-1.8|8.1||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The difference between groups in the proportions of patients reporting that they communicated with their clinicians about their end-of-life care preferences was estimated using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||8.1|-1.8|0.26
71739882|NCT03375489|142992748|EQUIVALENCE|Equivalence was established for patient length of stay in hospice if the 90% confidence interval for the estimated difference in mean days was within the margin of ±6 days.|Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|90.0|-7.0|7.4||Bonferroni-adjusted p-value|Regression, Linear|||The difference in mean length of stay in hospice between groups was estimated using a linear regression model with a main effect for group assignment.||7.4|-7.0|0.46
71739883|NCT03375489|142992749|SUPERIORITY||Difference in estimated proportions|-13.0|||<|0.001|TWO_SIDED|95.0|-17.6|-8.6||Bonferroni-adjusted p-value|binomial generalized estimating equation|||The proportion of palliative care visits with caregiver participation was compared using a binomial generalized estimating equation model with robust standard errors, the identity link function, and a main effect for group assignment.||-8.6|-17.6|<0.001
71739884|NCT03375489|142992750|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.99|TWO_SIDED|95.0|-1.0|1.7||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||1.7|-1.0|>0.99
71739885|NCT03375489|142992751|SUPERIORITY||Mean Difference (Final Values)|0.4|||>|0.99|TWO_SIDED|95.0|-1.5|2.3||Bonferroni-adjusted p-value|Regression, Linear|||The difference in week-24 means between groups was estimated using a linear regression model with a main effect for group assignment.||2.3|-1.5|>0.99
71739886|NCT00145574|142992773|SUPERIORITY_OR_OTHER|||||||0.1122|||||||ANCOVA|||The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%.||||0.1122
71739887|NCT00145574|142992773|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71739888|NCT00145574|142992774|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||ANCOVA|||||||0.5260
71739889|NCT00145574|142992774|SUPERIORITY_OR_OTHER|||||||0.0085||95.0|||||ANCOVA|||||||0.0085
71739890|NCT00145574|142992775|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71739891|NCT00145574|142992775|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
71739892|NCT00145574|142992776|SUPERIORITY_OR_OTHER|||||||0.0155||95.0|||||ANCOVA|||||||0.0155
71739893|NCT00145574|142992776|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71739894|NCT00145574|142992777|SUPERIORITY_OR_OTHER|||||||0.3482||95.0|||||ANCOVA|||||||0.3482
71739895|NCT00145574|142992777|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71739896|NCT00145574|142992778|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|||||||0.0002
71739897|NCT00145574|142992778|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71739898|NCT00145574|142992779|SUPERIORITY_OR_OTHER|||||||0.7433||95.0|||||ANCOVA|||||||0.7433
71739899|NCT00145574|142992779|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|||||||0.0003
71833622|NCT03089125|143171907|SUPERIORITY||Between-group diff in change per 8 weeks|0.74||||0.837|TWO_SIDED|95.0|-6.33|7.77|||Mixed Models Analysis|Estimated between-group difference in change in scores per every 8 weeks from baseline through week 24, controlling for cancer type and study site.||||7.77|-6.33|0.837
71661378|NCT01193127|142836531|SUPERIORITY_OR_OTHER||least-squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.6|1.1||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates|repeated measures model|All data time points collected used in the analysis.|OMS302 - Vehicle (BSS)|||1.1|0.6|0.0000
71833623|NCT04605198|143171911|SUPERIORITY|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.|Mean Difference (Net)|-0.58||||0.846|TWO_SIDED|95.0|-6.46|5.29|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|||5.29|-6.46|.846
71833624|NCT04605198|143171912|SUPERIORITY||Mean Difference (Net)|-1.88||||0.139|TWO_SIDED|95.0|-4.36|0.6|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.60|-4.36|.139
71833625|NCT04605198|143171913|SUPERIORITY||Mean Difference (Net)|-0.12||||0.222|TWO_SIDED|95.0|-1.21|0.97|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||0.97|-1.21|.222
71833626|NCT04605198|143171914|SUPERIORITY||Odds Ratio, log|-1.76||||0.166|TWO_SIDED|95.0|-4.26|0.73|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed using a logit distribution. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was included as a fixed-effect. An independent covariance pattern was specified. Final models were random-intercept only.||0.73|-4.26|0.166
71833627|NCT04605198|143171915|SUPERIORITY||Mean Difference (Net)|-0.52||||0.737|TWO_SIDED|95.0|-3.57|2.53|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||2.53|-3.57|.737
71890582|NCT03783195|143302706|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|20.57|STANDARD_ERROR_OF_MEAN|17.5||0.25|TWO_SIDED|95.0|-16.9|58.08||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum AST as compared to high GRS group.||58.08|-16.9|0.25
71661379|NCT01193127|142836531|SUPERIORITY_OR_OTHER||least-squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.1||0||95.0|0.5|0.9||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.|repeated measures model|OMS302 - ketorolac tromethamine||||0.9|0.5|0.0000
71661380|NCT01193127|142836532|SUPERIORITY_OR_OTHER||least-squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.2||0.0421||95.0|-8.9|-0.2||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates|repeated measures model||OMS302 - Vehicle (BSS)|||-0.2|-8.9|0.0421
71890583|NCT03783195|143302707|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED|95.0|-0.59|0.13|||t-test, 2 sided|||||0.13|-0.59|0.20
71661381|NCT01193127|142836532|SUPERIORITY_OR_OTHER||least-squares mean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.2||0.0093||95.0|-10.3|-1.5||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.|repeated measures model||OMS302 - PE|||-1.5|-10.3|0.0093
71661382|NCT01193127|142836533|SUPERIORITY_OR_OTHER|||||||0.63||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.630
71661383|NCT01193127|142836533|SUPERIORITY_OR_OTHER|||||||0.769||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.769
71739900|NCT02305238|142992796|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) mean difference|-0.4|||||TWO_SIDED|95.0|-3.8|3.0||||||||3.0|-3.8|
71890584|NCT03783195|143302708|OTHER||Mean Difference (Net)|28.95|STANDARD_ERROR_OF_MEAN|21.78||0.21|TWO_SIDED|95.0|-17.76|75.67||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum ALP as compared to high GRS group.||75.67|-17.76|0.21
71890585|NCT03783195|143302709|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.12||0.67|TWO_SIDED|95.0|-0.214|0.321|||t-test, 2 sided|||||0.321|-0.214|0.67
71890586|NCT03783195|143302710|OTHER|Both groups received the same intervention; however, their genetic make-up was different.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.12|0.28||All tests were individual tests.|Paired t-test|||The null hypothesis is that people with low GRS will have greater increase in serum GGT as compared to high GRS group.||0.28|-0.12|0.41
71833628|NCT04605198|143171916|SUPERIORITY||Mean Difference (Net)|-2391.98||||0.024|TWO_SIDED|95.0|-4471.46|-312.49|||Mixed Models Analysis||The estimate represents the interaction term for group by time interaction for the immediate follow-up, with the control group coded 0 and the intervention group coded as 1.|A multilevel model was constructed. Participants were entered as random effects to nest observations within participants. Group assignment (i.e., MBSR vs. Health Promotion Control), time (i.e., Time 1 \[baseline\], Time 2 \[immediate post-intervention, primary endpoint\], and Time 3 \[6-month follow-up\]), and group-by-time interactions were entered as fixed effects. Site was also included as a fixed-effect. An independent covariance pattern was specified as final models were random-intercept only.||-312.49|-4471.46|.024
71833629|NCT04038957|143171917|SUPERIORITY|||||||0.0072||||||A p-value of p\<0.05 will be considered as significant.|Repeated Measures ANOVA|||To examine the primary outcome, the effects of SEP-363856 on the striatum, a repeated measures ANOVA model will be build using the baseline and on-treatment kicer values of each striatal subregion.||||0.0072
71833630|NCT01998984|143171922|SUPERIORITY||Relative risk|2.97||||0.18|TWO_SIDED|95.0|0.6|14.74||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group."||14.74|0.60|0.18
71833631|NCT01998984|143171922|SUPERIORITY||Relative risk|3.51||||0.051|TWO_SIDED|95.0|1.0|12.41||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.~Type I error not controlled."||12.41|1.00|0.051
71833632|NCT01998984|143171922|SUPERIORITY||Relative risk|0.47||||0.25|TWO_SIDED|95.0|0.13|1.68||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Mantel Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Type I error not controlled. Mantel-Haenszel estimators were used."||1.68|0.13|0.25
71833633|NCT01998984|143171923|SUPERIORITY||Ratio of adjusted mean|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.51||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.51|0.32|<0.001
71833634|NCT01998984|143171923|SUPERIORITY||Ratio of adjusted mean|0.36|||<|0.001|TWO_SIDED|95.0|0.29|0.45||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||0.45|0.29|<0.001
71890587|NCT03783195|143302711|OTHER|Both groups received the same intervention; however, their genetic make-up was different|Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.15||0.49|TWO_SIDED|95.0|-0.44|0.22|||t-test, 2 sided|||||0.22|-0.44|0.49
71739901|NCT02305238|142992797|SUPERIORITY_OR_OTHER_LEGACY||Mantel-Haenszel (MH) adjusted difference|-0.9|||||TWO_SIDED|95.0|-5.7|4.0||||||||4.0|-5.7|
71739902|NCT02305238|142992798|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|-1.4|||||TWO_SIDED|95.0|-12.7|9.8||||||||9.8|-12.7|
71739903|NCT02305238|142992799|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.8|||||TWO_SIDED|95.0|-24.3|12.7||||||||12.7|-24.3|
71739904|NCT02305238|142992800|SUPERIORITY_OR_OTHER_LEGACY||MH adjusted difference|1.0|||||TWO_SIDED|95.0|-10.6|12.7||||||||12.7|-10.6|
71833635|NCT01998984|143171923|SUPERIORITY||Ratio of adjusted mean|0.89||||0.36|TWO_SIDED|95.0|0.7|1.14||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|||1.14|0.70|0.36
71890588|NCT03804671|143302742|OTHER|Absolute bioavailability. The statistical model was an ANOVA on the logarithmic scale including the fixed effect for 'formulation' and 'subject' as a random effect.|Ratio of the geometric means (T/R) %|70.32|||||TWO_SIDED|90.0|56.69|87.23|||||The geometric coefficient of variation (gCV) = 18.7. Ratio was calculated as (AUC0-∞/dose) oral /(AUC0-∞/dose) intravenous multiplied by 100.|||87.23|56.69|
71890589|NCT03902080|143302743|SUPERIORITY||Least square mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|-1.02|-0.46|||Mixed Models Analysis|||||-0.46|-1.02|<0.0001
71890590|NCT03902080|143302744|SUPERIORITY||Least Squares Means Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.211|<|0.0001|TWO_SIDED|95.0|-1.37|-0.54|||Mixed Models Analysis|||||-0.54|-1.37|<0.0001
71890591|NCT03902080|143302745|SUPERIORITY||Least Squares Means Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07|=|0.0015|TWO_SIDED|95.0|-0.36|-0.09|||Mixed Models Analysis|||||-0.09|-0.36|=0.0015
71775142|NCT01193660|143050553|SUPERIORITY_OR_OTHER_LEGACY||Wilks' Lambda (group*visit effect)|0.56|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.||||<0.05
71775143|NCT01193660|143050554|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Fisher Exact|We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.||||||<0.05
71775144|NCT03347188|143050555|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1876|TWO_SIDED|95.0|-0.73|3.67||Threshold for significance at 0.05 level.|ANCOVA|||||3.67|-0.73|0.1876
71775145|NCT02186873|143050573|SUPERIORITY_OR_OTHER||Difference in Percentage|47.1|||<|0.001|TWO_SIDED|95.0|35.18|58.99|||Cochran-Mantel-Haenszel|||||58.99|35.18|<0.001
71833636|NCT01998984|143171924|SUPERIORITY||Relative risk|32.26|||<|0.001|TWO_SIDED|95.0|4.39|236.8||P value adjusted for analysis site.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||236.8|4.39|<0.001
71890592|NCT03902080|143302746|SUPERIORITY||Least Squares Means Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.269|=|0.0034|TWO_SIDED|95.0|-1.33|-0.27|||Mixed Models Analysis|||||-0.27|-1.33|=0.0034
71890593|NCT03902080|143302747|SUPERIORITY||Least Squares Means Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Models Analysis|||||-0.5|-1.2|<0.0001
71890594|NCT03902080|143302748|SUPERIORITY||Least Squares Means Difference|15.07|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|9.13|21.02|||Mixed Models Analysis|||||21.02|9.13|<0.0001
71661384|NCT01193127|142836533|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.025
71661385|NCT01193127|142836534|SUPERIORITY_OR_OTHER|||||||0.229||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.229
71661386|NCT01193127|142836534|SUPERIORITY_OR_OTHER|||||||0.162||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.162
71775146|NCT00195273|143050579|SUPERIORITY_OR_OTHER|||||||0.6081||||||Calculated for 12 month analysis|ANOVA|Analysis of variance with treatment group and center as factors||||||0.6081
71775147|NCT00195273|143050582|SUPERIORITY_OR_OTHER|||||||0.4662|||||||ANOVA|Calculated for 3 month analysis||||||0.4662
71775148|NCT02595970|143050589|SUPERIORITY|adjusted for multiplicity using the Hochberg procedure.|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-24.52|20.59|||t-test, 2 sided|||||20.59|-24.52|<0.0001
71775149|NCT02595970|143050599|SUPERIORITY|adjusted|Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-23.52|19.58|||t-test, 2 sided|||||19.58|-23.52|<0.0001
71813046|NCT00514683|143128438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.225||||0.06|TWO_SIDED|95.0|0.048|1.065|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.065|0.048|0.0600
71813047|NCT00514683|143128439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.055||||0.7883|TWO_SIDED|95.0|0.713|1.563|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.563|0.713|0.7883
71813048|NCT00514683|143128439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958||||0.8293|TWO_SIDED|95.0|0.646|1.419|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.419|0.646|0.8293
71813049|NCT00514683|143128439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.805||||0.303|TWO_SIDED|95.0|0.534|1.216|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.216|0.534|0.3030
71813050|NCT00514683|143128439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.6505|TWO_SIDED|95.0|0.605|1.369|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.369|0.605|0.6505
71813051|NCT01564368|143128442|SUPERIORITY||area under the curve (AUC)|0.53||||0.484|ONE_SIDED|95.0||0.61||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC1 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.61||0.484
71813052|NCT01564368|143128442|SUPERIORITY||area under the curve|0.6||||0.017|ONE_SIDED|95.0||0.68||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC2 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.68||0.017
71833637|NCT01998984|143171924|SUPERIORITY||Relative risk|25.2||||0.002|TWO_SIDED|95.0|3.39|187.4||Adjusted for analysis site. Relative risk of partial clearance relative to vehicle group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||187.4|3.39|0.002
71833638|NCT01998984|143171924|SUPERIORITY||Relative risk|1.2||||0.28|TWO_SIDED|95.0|0.86|1.65||Adjusted for analysis site. Relative risk of partial clearance relative to 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.||1.65|0.86|0.28
71833639|NCT01843374|143171927|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.4081|TWO_SIDED|95.0|0.76|1.12||P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.|Log Rank|The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.|Tremelimumab represents the numerator and Placebo the denominator|H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo||1.12|0.76|0.4081
71833640|NCT01843374|143171928|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.011||||0.926|TWO_SIDED|95.0|0.793|1.289||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank||Tremelimumab is the numerator and Placebo the denominator|||1.289|0.793|0.926
71833641|NCT01843374|143171929|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81||||0.0325|TWO_SIDED|95.0|0.68|0.98||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank|Stratification factors were EORTC status and Line of therapy|Tremelimumab is the numerator and placebo, the denominator|||0.98|0.68|0.0325
71833642|NCT03397108|143171937|SUPERIORITY|||||||0.89||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk TNF levels at EARLY LACTATION PERIOD were compared between non-IBD control and women with IBD. Our hypothesis was that women with IBD have higher TNF in milk due to the underlying inflammatory condition (IBD).||||0.89
71833643|NCT03397108|143171937|SUPERIORITY|||||||0.024|||||||Kruskal-Wallis|||"Milk TNF at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.024
71833644|NCT03397108|143171937|SUPERIORITY|||||||0.7||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 levels (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.70
71833645|NCT03397108|143171937|SUPERIORITY|||||||0.93||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk levels of MIP-1 beta (TNF dependent chemokine) at the EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.93
71833646|NCT03397108|143171937|SUPERIORITY|||||||0.12||||||The a priori threshold of significance was set at 0.05. Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 levels (one of the TNF dependent chemokines) at EARLY LACTATION PERIOD were compared between non-IBD control and IBD group to see if there is a difference.||||0.12
71833647|NCT03397108|143171937|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||Milk levels of TNF-dependent chemokine, MCP1, at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control and the 2 IBD subgroups. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MCP1. Nonparametric comparison of the 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test.||||0.12
71833648|NCT03397108|143171937|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||"Milk MIP-1beta at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including MIP-1beta. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.051
71833649|NCT03397108|143171937|SUPERIORITY|||||||0.0046|||||||Kruskal-Wallis|||"Milk IP10 at the EARLY LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. We hypothesized that the use of TNFmAb decreases milk TNF and TNF-dependent chemokine including IP10. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.0046
71833650|NCT03397108|143171937|SUPERIORITY|||||||0.35||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Comparison of milk TNF level at the MID LACTATION POINT between non-IBD control and IBD group. The same analytical framework as the early lactation, but this is based on data at the mid-lactation point (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.35
71833651|NCT03397108|143171937|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||"Milk TNF at MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. Hypothesis is the same as for the early lactation point. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.11
71833652|NCT03397108|143171937|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MCP1 level comparison between non-IBD control and IBD group at the MID LACTATION POINT(13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.26
71833653|NCT03397108|143171937|SUPERIORITY|||||||0.15||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk MIP-1beta level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.15
71833654|NCT03397108|143171937|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||Milk IP10 level comparison between non-IBD control and IBD group at the MID LACTATION POINT (13-14 postpartum weeks). Our hypothesis is the same as for the early-lactation point.||||0.31
71833655|NCT03397108|143171937|SUPERIORITY|||||||0.21|||||||Kruskal-Wallis|||"Milk MCP-1 at the MID LACTATION PERIOD was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.21
71833656|NCT03397108|143171937|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||"Milk MIP-1beta at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The hypothesis is the same as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.12
71833657|NCT03397108|143171937|SUPERIORITY|||||||0.29|||||||Kruskal-Wallis|||"Milk IP10 at the MID LACTATION POINT was compared among the 3 groups: non-IBD control, IBD subgroup On TNFmAb and IBD subgroup Off TNFmAb. The same hypothesis as that for the early-lactation period. Nonparametric comparison of 3 groups was done with one-way ANOVA on ranks (Kruskal-Wallis test), followed by multiplicity-adjusted pairwise comparisons with Dunn's test."||||0.29
71833658|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.7232|||<|0.0001|TWO_SIDED|95.0|0.5647|0.8303||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MCP1 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MCP1.||0.8303|0.5647|<0.0001
71833659|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.6835|||<|0.0001|TWO_SIDED|95.0|0.5088|0.8042||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine MIP-1beta to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine MIP-1beta.||0.8042|0.5088|<0.0001
71833660|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.6316|||<|0.0001|TWO_SIDED|95.0|0.4377|0.7693||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the EARLY LACTATION, we analyzed correlation between milk TNF and chemokine IP10 to see if they are positively correlated. This is to show supportive evidence for TNF dependency of chemokine IP10.||0.7693|0.4377|<0.0001
71833661|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.572|||<|0.0001|TWO_SIDED|95.0|0.3445|0.736||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MCP1 to see of they are positively correlated.||0.7360|0.3445|<0.0001
71833662|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.7564|||<|0.0001|TWO_SIDED|95.0|0.6022|0.8562||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and MIP-1beta to see of they are positively correlated.||0.8562|0.6022|<0.0001
71890595|NCT00004054|143302790|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.76|1.43|||Log Rank|||The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.||1.43|0.76|0.81
71833663|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.32||||0.0227|TWO_SIDED|95.0|0.03869|0.552||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants at the MID LACTATION POINT, we analyzed correlation between milk TNF and IP10 to see of they are positively correlated.||0.5520|0.03869|0.0227
71833664|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.52||||0.0001|TWO_SIDED|95.0|0.2727|0.6975||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk TNF between early and mid-lactation points.||0.6975|0.2727|0.0001
71833665|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.4722||||0.0005|TWO_SIDED|95.0|0.2181|0.6664||Not adjusted for multiple comparison.|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MCP1 between early and mid-lactation points.||0.6664|0.2181|0.0005
71833666|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.36||||0.01|TWO_SIDED|95.0|0.0802|0.5803||Not adjusted for multiple comparison|Spearman rank correlation|||Using the pooled data of all participants, we assessed temporal tracking of milk MIP-1beta between early and mid-lactation points.||0.5803|0.0802|0.01
71833667|NCT03397108|143171937|OTHER|Correlation analysis|Spearman rank correlation|0.66|||<|0.0001|TWO_SIDED|95.0|0.467|0.7964||Not adjusted for multiple comparison|Spearman rank correlation|Spearman r = 0.66 (95%CI: 0.4670 - 0.7964). Number of XY pairs: 51||Using the pooled data of all participants, we assessed temporal tracking of milk IP10 between early and mid-lactation points.||0.7964|0.4670|<0.0001
71833668|NCT03397108|143171938|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Cognitive development at 12 months of age. Animal data suggested that pups receiving milk with lower TNF and TNF-dependent chemokines showed enhanced cognitive development. Because there was no guiding information in humans regarding milk TNF level differences between women with and without IBD, our main goal was to measure milk TNF levels. The infant cognitive/language assessment, therefore, had to be designed as a pilot and exploratory in nature.||||0.12
71833669|NCT03397108|143171938|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||Language development at 12 months of age.||||0.56
71833670|NCT03397108|143171938|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Cognitive development at 18 months of age.||||0.16
71833671|NCT03397108|143171938|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Language development at 18 months of age||||0.75
71890596|NCT00004054|143302791|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.82|TWO_SIDED|95.0|0.74|1.27|||Gray's test|2-sided significance level of 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.27|0.74|0.82
71833672|NCT03397108|143171938|OTHER|Correlation analysis|Spearman rank correlation|0.2655||||0.0853|TWO_SIDED|95.0|-0.047|0.5307|||Spearman rank correlation|||Using pooled data of all participants at the early-lactation sample point, correlation between milk TNF levels and 12 month cognitive development was examined to investigate if they were inversely correlated.||0.5307|-0.047|0.0853
71833673|NCT03397108|143171938|OTHER|Correlation analysis|Spearman rank correlation|0.3705||||0.09|TWO_SIDED|95.0|-0.07385|0.6921|||Spearman rank correlation|||Using the pooled data of all participants, correlation analysis between milk TNF at early lactation and 12 month language score was done to see if they were inversely correlated.||0.6921|-0.07385|0.090
71833674|NCT03397108|143171940|SUPERIORITY|||||||0.97||||||Not adjusted for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that the 2 groups are not different for their sampling time points in the early lactation period.||||0.97
71833675|NCT03397108|143171940|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||0.96
71833676|NCT03397108|143171941|SUPERIORITY|||||||0.56||||||No adjustment for multiple comparison.|Wilcoxon (Mann-Whitney)|||This is to confirm that there is no difference in the second sampling time points in the mid-lactation period between the groups.||||0.56
71833677|NCT03397108|143171941|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
71833678|NCT05057897|143171952|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.18|3.01|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.01|0.18|
71661387|NCT01193127|142836534|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
71661388|NCT01193127|142836535|SUPERIORITY_OR_OTHER|||||||0.177||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.177
71739905|NCT01100775|142992821|SUPERIORITY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Galantamine and Placebo Arms||||0.898
71739906|NCT01100775|142992821|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Galantamine and Placebo Arms||||0.701
71739907|NCT01100775|142992821|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Galantamine and Placebo Arms||||0.16
71739908|NCT01100775|142992821|SUPERIORITY|||||||0.701|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms between Galantamine and Placebo Arms||||0.701
71739909|NCT01100775|142992822|SUPERIORITY|||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Galantamine and Placebo Arms||||0.161
71739910|NCT01100775|142992822|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarm Reaction Time between Galantamine and Placebo Arms||||0.028
71739911|NCT01100775|142992822|SUPERIORITY|||||||0.899|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Galantamine and Placebo Arms||||0.899
71739912|NCT01100775|142992822|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Galantamine and Placebo Arms||||0.521
71739913|NCT01100775|142992823|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean total amount offered during the trust game between the galantamine and placebo groups||||0.67
71739914|NCT01100775|142992824|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Comparison of the mean correct responses between galantamine and placebo||||0.32
71739915|NCT01100775|142992825|SUPERIORITY|||||||0.659|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 1 between galantamine and placebo||||0.659
71739916|NCT01100775|142992825|SUPERIORITY|||||||0.541|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 2 between galantamine and placebo||||0.541
71739917|NCT01100775|142992825|SUPERIORITY|||||||0.838|||||||Wilcoxon (Mann-Whitney)|||Comparison of the number of correct response on Trial 3 between galantamine and placebo||||0.838
71739918|NCT01100775|142992826|SUPERIORITY|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||A comparison the mean correct responses between galantamine and placebo||||0.548
71739919|NCT01100775|142992827|SUPERIORITY|||||||0.871|||||||Wilcoxon (Mann-Whitney)|||||||0.871
71739920|NCT01100775|142992828|SUPERIORITY|||||||0.626|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect between galantamine and placebo||||0.626
71739921|NCT01100775|142992828|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill between galantamine and placebo||||0.234
71739922|NCT01100775|142992829|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Responses between galantamine and placebo||||0.797
71739923|NCT01100775|142992829|SUPERIORITY|||||||0.669|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total Hits between galantamine and placebo||||0.669
71739924|NCT01100775|142992829|SUPERIORITY|||||||0.668|||||||Wilcoxon (Mann-Whitney)|||Comparison of Facial Affect Total False Alarms between galantamine and placebo||||0.668
71739925|NCT04677504|142992836|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.14|||Regression, Cox|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.14|0.51|
71739926|NCT04677504|142992837|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8857|TWO_SIDED|95.0|0.64|1.47|||Log Rank|||"Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs.~eCCA vs. GBC), Geographic region (Asia vs. Rest of the World)."||1.47|0.64|0.8857
71739927|NCT04677504|142992841|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|0.93|2.63|||Regression, Cox|||Quality of Life||2.63|0.93|
71739928|NCT04677504|142992841|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.48|1.36|||Regression, Cox|||Physical Function Scale||1.36|0.48|
71739929|NCT04677504|142992841|SUPERIORITY|Stratified analysis. Stratification factors are: Location of primary tumor (iCCA vs. eCCA vs. GBC), Geographic region (Asia vs. Rest of the World).|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.68|1.85|||Regression, Cox|||Role Function Scale||1.85|0.68|
71739930|NCT00112125|142992856|NON_INFERIORITY|The primary safety analysis was a test of the non-inferiority of CCM therapy compared to OMT with respect to the proportion of subjects experiencing death or hospitalization within 50 weeks using the Blackwelder non-inferiority test12 with a prespecified non-inferiority margin of 0.125.||||||0.31|||||||Fisher Exact|||||||0.31
71739931|NCT00112125|142992857|NON_INFERIORITY|The noninferiority margin was selected to be 12.5% and α was set at .05, which resulted in a sample size of 198 subjects per group. A percentage of subjects (∼7%) were expected to be lost to followup, so that a total sample size of 428 subjects (214 per group) was selected.||||||0.125|||||||Blackwelder|||||||0.125
71739932|NCT03543137|142992872|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.88|1.02|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.02|0.88|
71739933|NCT03543137|142992873|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-inf fell completely within the range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.01|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.01|0.88|
71739934|NCT03543137|142992878|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the range.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.04|0.90|
71739935|NCT04072887|142992879|SUPERIORITY||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0235||0.628|TWO_SIDED|90.0|-0.027|0.05|||ANCOVA|||||0.050|-0.027|0.628
71739936|NCT04072887|142992879|SUPERIORITY||Least Squares Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.0144||0.425|TWO_SIDED|90.0|-0.012|0.035|||ANCOVA|||||0.035|-0.012|0.425
71739937|NCT04072887|142992879|SUPERIORITY||Least Squares Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.0174||0.463|TWO_SIDED|90.0|-0.016|0.041|||ANCOVA|||||0.041|-0.016|0.463
71739938|NCT04072887|142992879|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.0173||0.244|TWO_SIDED|90.0|-0.008|0.049|||ANCOVA|||||0.049|-0.008|0.244
71739939|NCT04072887|142992879|SUPERIORITY||Least Squares Mean Difference|0.005|STANDARD_ERROR_OF_MEAN|0.0176||0.793|TWO_SIDED|90.0|-0.024|0.034|||ANCOVA|||||0.034|-0.024|0.793
71739940|NCT02697435|142992895|SUPERIORITY||||||<|0.05||||||P-value is calculated.|Mixed Models Analysis|||||||<0.05
71739941|NCT04371666|142992900|OTHER||Least square (LS) Mean Difference|0.083|STANDARD_ERROR_OF_MEAN|0.5494||0.8802|TWO_SIDED|95.0|-1.01|1.176||Threshold for significance at 0.05 level.|Random coefficient model|||||1.176|-1.010|0.8802
71739942|NCT00445770|142992923|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Based on rank transformed data: rank of change = rank baseline+treatment +pooled study center+prior methotrexate use. If overall treatment effect statistically significant, 3 pairwise comparisons conducted, otherwise no further testing was made.|ANCOVA|||It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.||||<0.0001
71775150|NCT01886716|143050606|SUPERIORITY_OR_OTHER||Slope|-0.8|STANDARD_ERROR_OF_MEAN|0.95|=|0.4|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .71|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training."||||=.40
71775151|NCT01886716|143050606|SUPERIORITY_OR_OTHER||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.95|=|0.78|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .08|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training."||||=.78
71661389|NCT01193127|142836535|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.051
71739943|NCT00445770|142992923|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
71739944|NCT00445770|142992923|NON_INFERIORITY_OR_EQUIVALENCE|An outcome showing that etanercept 10 mg was superior to methotrexate and the presence of numerical difference ≤0.5 mTSS units between etanercept 25 mg and etanercept 10 mg would support non-inferiority for the 2 etanercept treatments.||||||0.2634|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2634
71739945|NCT00445770|142992924|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
71739946|NCT00445770|142992924|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||<0.0001
71739947|NCT00445770|142992924|SUPERIORITY_OR_OTHER|||||||0.2248|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||||||0.2248
71739948|NCT00445770|142992925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
71739949|NCT00445770|142992925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
71739950|NCT00445770|142992925|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.7260
71739951|NCT00445770|142992925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
71833679|NCT05057897|143171953|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-30.36|||||TWO_SIDED|95.0|-62.82|3.69||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||3.69|-62.82|
71661390|NCT01193127|142836535|SUPERIORITY_OR_OTHER|||||||0.497||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.497
71661391|NCT01193127|142836536|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
71661392|NCT01193127|142836536|SUPERIORITY_OR_OTHER|||||||0.09||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.090
71661393|NCT01193127|142836536|SUPERIORITY_OR_OTHER|||||||0.439||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.439
71661394|NCT01193127|142836537|SUPERIORITY_OR_OTHER|||||||0.812||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.812
71661395|NCT01193127|142836537|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.480
71661396|NCT01193127|142836537|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
71661397|NCT01193127|142836538|SUPERIORITY_OR_OTHER|||||||0.085||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.085
71661398|NCT01193127|142836538|SUPERIORITY_OR_OTHER|||||||0.742||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.742
71661399|NCT01193127|142836538|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.021
71661400|NCT01193127|142836539|SUPERIORITY_OR_OTHER|||||||0.081||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.081
71661401|NCT01193127|142836539|SUPERIORITY_OR_OTHER|||||||0.202||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.202
71661402|NCT01193127|142836539|SUPERIORITY_OR_OTHER|||||||0.606||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.606
71661403|NCT01193127|142836540|SUPERIORITY_OR_OTHER|||||||0.893||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.893
71661404|NCT01193127|142836540|SUPERIORITY_OR_OTHER|||||||0.553||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.553
71661405|NCT01193127|142836540|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.412
71661406|NCT01193127|142836541|SUPERIORITY_OR_OTHER|||||||0.186||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.186
71661407|NCT01193127|142836541|SUPERIORITY_OR_OTHER|||||||0.191||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.191
71661408|NCT01193127|142836541|SUPERIORITY_OR_OTHER|||||||0.167||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.167
71661409|NCT01193127|142836542|SUPERIORITY_OR_OTHER|||||||0.663||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.663
71661410|NCT01193127|142836542|SUPERIORITY_OR_OTHER|||||||0.326||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.326
71661411|NCT01193127|142836542|SUPERIORITY_OR_OTHER|||||||0.045||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.045
71661412|NCT01193127|142836543|SUPERIORITY_OR_OTHER|||||||0.106||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.106
71661413|NCT01193127|142836543|SUPERIORITY_OR_OTHER|||||||0.519||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.519
71661414|NCT01193127|142836543|SUPERIORITY_OR_OTHER|||||||0.039||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.039
71833680|NCT05057897|143171954|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.47|||||TWO_SIDED|95.0|0.06|3.86|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 57 (28 days post Dose 2)||3.86|0.06|
71775152|NCT01886716|143050607|SUPERIORITY_OR_OTHER||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.07|=|0.67|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = .18|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training"||||=.67
71775153|NCT01886716|143050607|SUPERIORITY_OR_OTHER||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.07|=|0.32|TWO_SIDED||||||Mixed Models Analysis||F(1,517) = 1.01|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training"||||=.32
71775154|NCT00810108|143050634|NON_INFERIORITY_OR_EQUIVALENCE|The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.|Ratio of Crushed/Whole Tablet AUC|0.55|||<|0.05|TWO_SIDED|90.0|0.45|0.69|||t-test, 2 sided|||Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.||0.69|0.45|<0.05
71775155|NCT00137631|143050666|SUPERIORITY_OR_OTHER||Rate Ratio|0.58|||<|0.05||95.0|0.33|1.01|||negative binomial regression|||||1.01|0.33|< 0.05
71661415|NCT01193127|142836544|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.100
71775156|NCT00137631|143050667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||<|0.05||95.0|1.05|1.68|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.68|1.05|< 0.05
71775157|NCT00137631|143050668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17|||<|0.05||95.0|0.69|1.98|||Mixed Models Analysis|||||1.98|0.69|< 0.05
71775158|NCT00137631|143050669|SUPERIORITY_OR_OTHER||Rate Ratio|0.49|||<|0.05||95.0|0.28|0.87|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||0.87|0.28|< 0.05
71775159|NCT00137631|143050670|SUPERIORITY_OR_OTHER||Rate Ratio|0.8|||<|0.05||95.0|0.42|1.53|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)||||1.53|0.42|< 0.05
71775160|NCT00351000|143050678|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||t-test, 2 sided|||||||0.956
71775161|NCT00351000|143050679|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
71775162|NCT05015530|143050775|SUPERIORITY|||||||0.908|||||||Kruskal-Wallis|||α-diversity assessed using the Kruskal-Wallis test||||0.908
71775163|NCT01539642|143050781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.02|STANDARD_ERROR_OF_MEAN|15.25||0.001|TWO_SIDED|95.0|19.89|80.14|||ANCOVA|||||80.14|19.89|0.001
71775164|NCT01859143|143050798|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence criterion for fever within 7 days of vaccination mentioned that the upper limit of 95 percent (%) confidence interval (CI) for difference in percentage of participants with fever \>=101 degrees F should be less than 5 percentage points.|Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||A two-sided 95% CI was constructed using the exact method based on the score statistic proposed by Chan and Zhang.|||2.6|-5.3|
71775165|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|11.9|||||TWO_SIDED|95.0|-1.9|23.9|||||Any symptom within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||23.9|-1.9|
71775166|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>100 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
71775167|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
71775168|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
71775169|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|8.9|||||TWO_SIDED|95.0|-2.6|17.7|||||Runny nose within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||17.7|-2.6|
71775170|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|6.2|||||TWO_SIDED|95.0|-2.2|11.6|||||Sore throat within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.6|-2.2|
71775171|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|-0.5|||||TWO_SIDED|95.0|-9.3|4.7|||||Cough within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.7|-9.3|
71775172|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Vomiting within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
71775173|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|-0.1|||||TWO_SIDED|95.0|-8.0|4.3|||||Muscle aches within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.3|-8.0|
71775174|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|1.7|||||TWO_SIDED|95.0|-4.1|4.4|||||Chills within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.4|-4.1|
71775175|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|3.2|||||TWO_SIDED|95.0|-6.5|9.8|||||Decreased activity (tiredness) within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||9.8|-6.5|
71775176|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|3.5|||||TWO_SIDED|95.0|-7.8|11.9|||||Headache within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.9|-7.8|
71775177|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|12.3|||||TWO_SIDED|95.0|-1.6|24.4|||||Any symptom within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||24.4|-1.6|
71775178|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|1.2|||||TWO_SIDED|95.0|-4.5|3.9|||||Fever \>100 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.9|-4.5|
71775179|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.8|||||TWO_SIDED|95.0|-4.9|3.3|||||Fever \>=101 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||3.3|-4.9|
71775180|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>102 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
71775181|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-6.1|1.8|||||Fever \>103 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||1.8|-6.1|
71775182|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|9.7|||||TWO_SIDED|95.0|-1.8|18.6|||||Runny nose within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||18.6|-1.8|
71775183|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Sore throat within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
71775184|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-8.6|5.7|||||Cough within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.7|-8.6|
71775185|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.4|||||TWO_SIDED|95.0|-5.3|2.6|||||Vomiting within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||2.6|-5.3|
71775186|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|0.3|||||TWO_SIDED|95.0|-7.8|4.8|||||Muscle aches within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||4.8|-7.8|
71775187|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|2.5|||||TWO_SIDED|95.0|-3.3|5.5|||||Chills within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||5.5|-3.3|
71775188|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|4.4|||||TWO_SIDED|95.0|-5.3|11.2|||||Decreased activity (tiredness) within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||11.2|-5.3|
71775189|NCT01859143|143050799|SUPERIORITY_OR_OTHER||Percent difference|3.0|||||TWO_SIDED|95.0|-8.7|12.0|||||Headache within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang's method.|||12.0|-8.7|
71775190|NCT00438451|143050803|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||Fisher Exact|||||||0.0201
71775191|NCT00438451|143050803|SUPERIORITY_OR_OTHER|||||||0.1536||95.0|||||Fisher Exact|||||||0.1536
71775192|NCT00438451|143050803|SUPERIORITY_OR_OTHER|||||||0.3615||95.0|||||Fisher Exact|||||||0.3615
71775193|NCT00438451|143050803|SUPERIORITY_OR_OTHER|||||||0.0478||95.0|||||Fisher Exact|||||||0.0478
71661416|NCT01193127|142836544|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.029
71775194|NCT00438451|143050803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.838||||0.0578|TWO_SIDED|95.0|1.092|3.093|||Regression, Logistic|adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)|"Odds ratio given here is for comparison LEV vs CBZ: OR=1.838 KI=(1.092-3.093) LEV vs LTG: OR=1.169 KI=(0.689-1.984) CBZ vs LTG: OR=0.636 KI=(0.377-1.073) Number of concurrent diseases: OR=0.921 KI=(0.859-0.987)"|||3.093|1.092|0.0578
71661417|NCT01193127|142836544|SUPERIORITY_OR_OTHER|||||||0.525||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.525
71775195|NCT00438451|143050804|SUPERIORITY_OR_OTHER|||||||0.0596||95.0|||||Log Rank|||||||0.0596
71775196|NCT00438451|143050805|SUPERIORITY_OR_OTHER|||||||0.2517||95.0|||||Fisher Exact|||||||0.2517
71775197|NCT00438451|143050806|SUPERIORITY_OR_OTHER|||||||0.3303||95.0|||||Fisher Exact|||||||0.3303
71775198|NCT00438451|143050807|SUPERIORITY_OR_OTHER|||||||0.5022||95.0|||||Log Rank|||||||0.5022
71775199|NCT02413372|143050815|SUPERIORITY||Mean Difference (Final Values)|-7.17|||||TWO_SIDED|90.0|-9.09|-5.26|||||mean difference in adjusted change from baseline vs placebo|Day 57||-5.26|-9.09|
71775200|NCT02413372|143050815|SUPERIORITY||Mean Difference (Final Values)|-5.19|||||TWO_SIDED|90.0|-7.14|-3.25|||||mean difference in adjusted change from baseline vs placebo|Day 57||-3.25|-7.14|
71775201|NCT02413372|143050815|SUPERIORITY||Mean Difference (Final Values)|-5.43||||0.0004|TWO_SIDED|90.0|-8.01|-2.84|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-2.84|-8.01|0.0004
71775202|NCT02413372|143050815|SUPERIORITY||Mean Difference (Final Values)|-3.85||||0.0084|TWO_SIDED|90.0|-6.47|-1.23|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112||-1.23|-6.47|0.0084
71775203|NCT02617888|143050870|SUPERIORITY||Slope|0.08|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71775204|NCT00568685|143050896|SUPERIORITY_OR_OTHER|||||||0.0048||95.0||||This is the p value for CGI-ADHD-S score change at endpoint|Mixed Models Analysis|||||||0.0048
71775205|NCT00568685|143050897|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||This is the p value for CGI-ADHD-I score change at endpoint|Mixed Models Analysis|||||||0.0153
71775206|NCT00568685|143050898|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P-value relates to the sum of adverse events leading to discontinuation.|Fisher Exact|||||||.4500
71775207|NCT00568685|143050899|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|||||||0.0240
71775208|NCT00568685|143050901|SUPERIORITY_OR_OTHER|||||||0.8005||95.0||||This is the p value for heart rate change at endpoint|ANOVA|||||||0.8005
71775209|NCT00568685|143050902|SUPERIORITY_OR_OTHER|||||||0.4128||95.0||||This is the p value for temperature change at endpoint|ANOVA|||||||0.4128
71775210|NCT00568685|143050903|SUPERIORITY_OR_OTHER|||||||0.9761||95.0||||This is the p value for systolic change at endpoint|ANOVA|||||||0.9761
71775211|NCT00568685|143050903|SUPERIORITY_OR_OTHER|||||||0.6419||95.0||||This is the p value for diastolic change at endpoint|ANOVA|||||||0.6419
71890597|NCT00004054|143302792|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.09|TWO_SIDED|95.0|0.28|1.1|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.10|0.28|0.09
71890598|NCT00004054|143302793|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.42|TWO_SIDED|95.0|0.48|1.36|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.36|0.48|0.42
71890599|NCT00004054|143302794|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.61|TWO_SIDED|95.0|0.75|1.19|||Log Rank|2-sided significance level = 0.05|Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.|||1.19|0.75|0.61
71890600|NCT01053312|143302819|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.688||||0.098|TWO_SIDED||||||Regression, Linear|||Contralateral to the biopsy Site||||0.098
71890601|NCT01053312|143302819|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.482||||0.268|||||||Regression, Linear|||Ipsilateral to the biopsy Site||||0.268
71775212|NCT00568685|143050904|SUPERIORITY_OR_OTHER|||||||0.2213||95.0||||This is the p value for weight change at endpoint|ANOVA|||||||0.2213
71775213|NCT02787551|143050913|SUPERIORITY||Least square (LS) mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.77|-0.508||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.||-0.508|-0.770|<0.0001
71775214|NCT02787551|143050915|SUPERIORITY||Difference in percentage|36.05|||<|0.0001|TWO_SIDED|95.0|28.11|43.99||Threshold for significance \<=0.05|Cochran-Mantel-Haenszel|||HbA1c \<7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c \< 7% was part of testing).||43.99|28.11|<.0001
71775215|NCT02787551|143050917|SUPERIORITY||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.168|<|0.0001|TWO_SIDED|95.0|-2.001|-1.341||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-1.341|-2.001|<0.0001
71775216|NCT02787551|143050919|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.157|<|0.0001|TWO_SIDED|95.0|-1.325|-0.708||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).||-0.708|-1.325|<0.0001
71775217|NCT02787551|143050921|SUPERIORITY||LS Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-3.42|-2.279||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-2.279|-3.420|<0.0001
71775218|NCT02787551|143050923|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.468|-0.508||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (\<8.0%, \>=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).||-0.508|-1.468|<0.0001
71775219|NCT01532973|143050949|SUPERIORITY_OR_OTHER||Difference in LS Means|4.26|||||TWO_SIDED|90.0|3.77|4.74||||||||4.74|3.77|
71775220|NCT01532973|143050949|SUPERIORITY_OR_OTHER||Difference in LS Means|4.41|||||TWO_SIDED|90.0|3.92|4.9||||||||4.90|3.92|
71775221|NCT01532973|143050949|SUPERIORITY_OR_OTHER||Difference in LS Means|3.56|||||TWO_SIDED|90.0|3.08|4.05||||||||4.05|3.08|
71775222|NCT01532973|143050950|SUPERIORITY_OR_OTHER||Difference in LS Means|1.02|||||TWO_SIDED|90.0|0.34|1.69||||||||1.69|0.34|
71775223|NCT01532973|143050950|SUPERIORITY_OR_OTHER||Difference in LS Means|2.07|||||TWO_SIDED|90.0|1.39|2.74||||||||2.74|1.39|
71775224|NCT01532973|143050950|SUPERIORITY_OR_OTHER||Difference in LS Means|2.72|||||TWO_SIDED|90.0|2.05|3.39||||||||3.39|2.05|
71775225|NCT01532973|143050951|SUPERIORITY_OR_OTHER||Difference in LS Means|3.2|||||TWO_SIDED|90.0|2.68|3.72||||||||3.72|2.68|
71775226|NCT01532973|143050951|SUPERIORITY_OR_OTHER||Difference in LS Means|3.95|||||TWO_SIDED|90.0|3.44|4.47||||||||4.47|3.44|
71775227|NCT01532973|143050952|SUPERIORITY_OR_OTHER||Difference in LS Means|3.89|||||TWO_SIDED|90.0|3.2|4.58||||||||4.58|3.20|
71775228|NCT01532973|143050952|SUPERIORITY_OR_OTHER||Difference in LS Means|4.67|||||TWO_SIDED|90.0|3.98|5.36||||||||5.36|3.98|
71775229|NCT01532973|143050952|SUPERIORITY_OR_OTHER||Difference in LS Means|3.61|||||TWO_SIDED|90.0|2.92|4.3||||||||4.30|2.92|
71775230|NCT01532973|143050953|SUPERIORITY_OR_OTHER||Difference in LS Means|0.72|||||TWO_SIDED|90.0|-0.09|1.54||||||||1.54|-0.09|
71775231|NCT01532973|143050953|SUPERIORITY_OR_OTHER||Difference in LS Means|2.57|||||TWO_SIDED|90.0|1.75|3.39||||||||3.39|1.75|
71775232|NCT01532973|143050953|SUPERIORITY_OR_OTHER||Difference in LS Means|2.84|||||TWO_SIDED|90.0|2.02|3.66||||||||3.66|2.02|
71739952|NCT00445770|142992925|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
71739953|NCT00445770|142992925|SUPERIORITY_OR_OTHER|||||||0.5717|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.5717
71739954|NCT00445770|142992926|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||<0.0001
71739955|NCT00445770|142992926|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0013
71739956|NCT00445770|142992926|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24||||0.0186
71739957|NCT00445770|142992926|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||<0.0001
71775233|NCT01532973|143050954|SUPERIORITY_OR_OTHER||Difference in LS Means|3.17|||||TWO_SIDED|90.0|2.55|3.8||||||||3.80|2.55|
71775234|NCT01532973|143050954|SUPERIORITY_OR_OTHER||Difference in LS Means|3.63|||||TWO_SIDED|90.0|3.0|4.26||||||||4.26|3.00|
71775235|NCT00567593|143051053|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test||||||.01
71739958|NCT00445770|142992926|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.0006
71739959|NCT00445770|142992926|SUPERIORITY_OR_OTHER|||||||0.1123|TWO_SIDED|||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52||||0.1123
71739960|NCT00445770|142992927|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||<0.0001
71775236|NCT01675427|143051072|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0018
71775237|NCT01675427|143051072|SUPERIORITY_OR_OTHER|||||||0.2289|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.2289
71775238|NCT01675427|143051072|SUPERIORITY_OR_OTHER|||||||0.1112|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1112
71775239|NCT01675427|143051072|SUPERIORITY_OR_OTHER|||||||0.4681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.4681
71775240|NCT01675427|143051072|SUPERIORITY_OR_OTHER|||||||0.4828|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4828
71775241|NCT01675427|143051072|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.2702
71775242|NCT01675427|143051073|SUPERIORITY_OR_OTHER|||||||0.4133|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.4133
71775243|NCT01675427|143051073|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.4400
71739961|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.0002
71739962|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.3022|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=0.5||||0.3022
71739963|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0001
71739964|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.0002
71739965|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=3.0||||0.3120
71739966|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use.|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0010
71739967|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.0285|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0285
71739968|NCT00445770|142992927|SUPERIORITY_OR_OTHER|||||||0.0433|TWO_SIDED|||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression \<=SDD||||0.0433
71739969|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.0032|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0032
71739970|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71739971|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.1224|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.1224
71775244|NCT01675427|143051073|SUPERIORITY_OR_OTHER|||||||0.8597|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.8597
71775245|NCT01675427|143051073|SUPERIORITY_OR_OTHER|||||||0.3975|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.3975
71833681|NCT05057897|143171955|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|-25.0|||||TWO_SIDED|95.0|-59.07|2.97||||The 2-sided 95% CI was calculated using the Newcombe score without continuity correction.|The difference in seroresponse 28 days post Dose 2 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 57 (28 days post Dose 2)||2.97|-59.07|
71833682|NCT05057897|143171956|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.32|||||TWO_SIDED|95.0|0.12|0.8|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||0.80|0.12|
71833683|NCT05057897|143171957|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
71833684|NCT05057897|143171958|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.25|1.25|||||The GMT ratio was calculated as the ratio of the titer levels in the immunocompromised cohort to the immunocompetent cohort.|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||1.25|0.25|
71833685|NCT05057897|143171959|OTHER|Descriptive only. Analysis conducted at request of clinicaltrials.gov.|Difference in Seroresponse|0.0||||||||||||Due to everyone in both cohorts being a seroresponder, the confidence interval (CI) around the difference is not estimable.|The difference in seroresponse 28 days post Dose 3 of AZD1222 was calculated as (seroresponse rate of immunocompromised cohort) - (seroresponse rate of immunocompetent cohort).|Day 85 Immunocompromised / Day 211 Immunocompetent (28 days post Dose 3)||||
71833686|NCT04714320|143171960|SUPERIORITY||||||=|0.135||||||The stratification factor (screening estimated glomerular filtration rate (eGFR) status \[\<60 vs. ≥60 mL/min/1.73 m\^2\]), treatment received, and baseline measure were included in the analysis of covariate (ANCOVA) model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.135
71833687|NCT04714320|143171960|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in Seated Automated Office SBP to Day 85||||=0.867
71833688|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
71890602|NCT01053312|143302819|NON_INFERIORITY_OR_EQUIVALENCE|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.685||||0.099|||||||Regression, Linear|||Composite Region||||0.099
71661418|NCT01193127|142836545|SUPERIORITY_OR_OTHER|||||||0.642||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.642
71661419|NCT01193127|142836545|SUPERIORITY_OR_OTHER|||||||0.442||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.442
71661420|NCT01193127|142836545|SUPERIORITY_OR_OTHER|||||||0.467||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.467
71833689|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline at Day 15||||<0.001
71833690|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
71833691|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||<0.001
71833692|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
71833693|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||<0.001
71833694|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
71833695|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||<0.001
71833696|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
71833697|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 71||||<0.001
71833698|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
71739972|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71739973|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71739974|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.8037|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.8037
71739975|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71739976|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71739977|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.5495|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5495
71739978|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71739979|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71739980|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.4948|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4948
71775246|NCT01675427|143051073|SUPERIORITY_OR_OTHER|||||||0.1781|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1781
71739981|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71739982|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71739983|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.4663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4663
71775247|NCT01675427|143051073|SUPERIORITY_OR_OTHER|||||||0.3159|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3159
71775248|NCT01675427|143051074|SUPERIORITY_OR_OTHER|||||||0.0126|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.0126
71775249|NCT01675427|143051074|SUPERIORITY_OR_OTHER|||||||0.7174|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.7174
71775250|NCT01675427|143051074|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.1380
71739984|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71739985|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71739986|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.9357|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9357
71739987|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71739988|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71739989|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.7439|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.7439
71739990|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71739991|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71739992|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.8611|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8611
71739993|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71739994|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71739995|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.6731|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.6731
71739996|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71739997|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71739998|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.2616|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.2616
71775251|NCT01675427|143051074|SUPERIORITY_OR_OTHER|||||||0.6258|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.6258
71775252|NCT01675427|143051074|SUPERIORITY_OR_OTHER|||||||0.5751|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.5751
71833699|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 85||||<0.001
71833700|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
71833701|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||<0.001
71833702|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
71833703|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||<0.001
71833704|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
71833705|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 120||||<0.001
71833706|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||<0.001
71661421|NCT01193127|142836546|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.695
71890603|NCT00619957|143302860|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|4.53|||<|0.0001|TWO_SIDED|95.0|3.46|5.6|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.60|3.46|<0.0001
71661422|NCT01193127|142836546|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
71661423|NCT01193127|142836546|SUPERIORITY_OR_OTHER|||||||0.369||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.369
71833707|NCT04714320|143171962|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 148||||=0.002
71833708|NCT04714320|143171962|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||<0.001
71833709|NCT04714320|143171962|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 169||||=0.002
71833710|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
71833711|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 15||||<0.001
71833712|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
71833713|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day at 29||||<0.001
71833714|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
71833715|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 43||||<0.001
71833716|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
71833717|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 57||||<0.001
71833718|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
71661424|NCT01193127|142836547|SUPERIORITY_OR_OTHER|||||||0.124||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.124
71833719|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 71||||<0.001
71833720|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
71833721|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 85||||<0.001
71833722|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
71833723|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables|Van Elteren|||Percent Change from Baseline at Day 92||||<0.001
71833724|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
71833725|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 106||||<0.001
71833726|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
71890604|NCT00619957|143302861|SUPERIORITY_OR_OTHER||LS Mean Difference|2.56|||<|0.0001|TWO_SIDED|95.0|1.66|3.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.47|1.66|<0.0001
71890605|NCT00619957|143302862|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|||<|0.0001|TWO_SIDED|95.0|2.19|4.16|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||4.16|2.19|<0.0001
71833727|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 120||||<0.001
71833728|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||<0.001
71833729|NCT04714320|143171963|SUPERIORITY||||||=|0.005||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Percent Change from Baseline at Day 148||||=0.005
71833730|NCT04714320|143171963|SUPERIORITY||||||<|0.001||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||<0.001
71833731|NCT04714320|143171963|SUPERIORITY||||||=|0.002||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received were included in the Van Elteren model as independent variables.|Van Elteren|||Percent Change from Baseline at Day 169||||=0.002
71833732|NCT04714320|143171964|SUPERIORITY||||||=|0.094||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.094
71833733|NCT04714320|143171964|SUPERIORITY||||||=|0.842||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline in 24-hour Mean SBP at Day 85||||=0.842
71833734|NCT04714320|143171964|SUPERIORITY||||||=|0.066||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.066
71833735|NCT04714320|143171964|SUPERIORITY||||||=|0.442||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change From Baseline in 24-hour Mean DBP at Day 85||||=0.442
71833736|NCT04714320|143171965|SUPERIORITY||||||=|0.834||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.834
71833737|NCT04714320|143171965|SUPERIORITY||||||=|0.945||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 8||||=0.945
71739999|NCT00445770|142992928|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740000|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
71740001|NCT00445770|142992928|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1158
71740002|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740003|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740004|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.4237
71740005|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740006|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0002
71740007|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.5738|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5738
71833738|NCT04714320|143171965|SUPERIORITY||||||=|0.208||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.208
71740008|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740009|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740010|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.1606|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1606
71740011|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740012|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0016
71740013|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.2412
71740014|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740015|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740016|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.5882|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5882
71740017|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740018|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0001
71740019|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.2257|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2257
71740020|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740021|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0003
71740022|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.2075|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2075
71740023|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740024|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0050
71740025|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0461|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0461
71833739|NCT04714320|143171965|SUPERIORITY||||||=|0.74||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 15||||=0.740
71661425|NCT01193127|142836547|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
71661426|NCT01193127|142836547|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
71661427|NCT01193127|142836548|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.825
71775253|NCT01675427|143051074|SUPERIORITY_OR_OTHER|||||||0.1681|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.1681
71661428|NCT01193127|142836548|SUPERIORITY_OR_OTHER|||||||0.211||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.211
71661429|NCT01193127|142836548|SUPERIORITY_OR_OTHER|||||||0.589||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.589
71740026|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0002
71740027|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0101
71740028|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.2351|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.2351
71740029|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
71740030|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.1179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1179
71740031|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0214|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0214
71775254|NCT01675427|143051075|SUPERIORITY_OR_OTHER|||||||0.2693|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||0.2693
71775255|NCT01675427|143051075|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.3240
71775256|NCT01675427|143051075|SUPERIORITY_OR_OTHER|||||||0.7006|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7006
71775257|NCT01675427|143051075|SUPERIORITY_OR_OTHER|||||||0.0403|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.0403
71775258|NCT01675427|143051075|SUPERIORITY_OR_OTHER|||||||0.1075|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.1075
71775259|NCT01675427|143051075|SUPERIORITY_OR_OTHER|||||||0.3295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.3295
71775260|NCT01675427|143051076|SUPERIORITY_OR_OTHER|||||||0.9859|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9859
71661430|NCT01193127|142836549|SUPERIORITY_OR_OTHER|||||||0.401||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.401
71661431|NCT01193127|142836549|SUPERIORITY_OR_OTHER|||||||0.2||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Chi-squared, Corrected|||||||0.200
71661432|NCT01193127|142836549|SUPERIORITY_OR_OTHER|||||||0.478||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.478
71740032|NCT00445770|142992929|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740033|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0790
71740034|NCT00445770|142992929|SUPERIORITY_OR_OTHER|||||||0.0168|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0168
71740035|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740036|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740037|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.6337|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6337
71740038|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740039|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740040|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.7407|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.7407
71775261|NCT01675427|143051076|SUPERIORITY_OR_OTHER|||||||0.7055|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.7055
71890606|NCT00619957|143302863|SUPERIORITY_OR_OTHER||LS Mean Difference|4.57|||<|0.0001|TWO_SIDED|95.0|3.49|5.66|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||5.66|3.49|<0.0001
71890607|NCT00619957|143302864|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1856|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||0.99|-0.19|0.1856
71890608|NCT00619957|143302865|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.0346|TWO_SIDED|95.0|0.05|1.25|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.25|0.05|0.0346
71890609|NCT00619957|143302866|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|0.98|2.41|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.41|0.98|<0.0001
71890610|NCT00619957|143302867|SUPERIORITY_OR_OTHER||LS Mean Difference|1.46|||<|0.0001|TWO_SIDED|95.0|0.76|2.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.17|0.76|<0.0001
71890611|NCT00619957|143302868|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.2538|TWO_SIDED|95.0|-0.36|1.36|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.36|-0.36|0.2538
71890612|NCT00619957|143302869|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86||||0.0537|TWO_SIDED|95.0|-0.01|1.74|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.74|-0.01|0.0537
71890613|NCT00619957|143302870|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.0081|TWO_SIDED|95.0|0.32|2.15|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||2.15|0.32|0.0081
71890614|NCT00619957|143302871|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06||||0.0187|TWO_SIDED|95.0|0.18|1.94|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.94|0.18|0.0187
71661433|NCT01193127|142836550|SUPERIORITY_OR_OTHER|||||||0.758||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.758
71661434|NCT01193127|142836550|SUPERIORITY_OR_OTHER|||||||0.521||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.521
71740041|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740042|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740043|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.3473|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.3473
71740044|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740045|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71833740|NCT04714320|143171965|SUPERIORITY||||||=|0.019||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.019
71661435|NCT01193127|142836550|SUPERIORITY_OR_OTHER|||||||0.432||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.432
71833741|NCT04714320|143171965|SUPERIORITY||||||=|0.56||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in the Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 22||||=0.560
71833742|NCT04714320|143171965|SUPERIORITY||||||=|0.903||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.903
71833743|NCT04714320|143171965|SUPERIORITY||||||=|0.268||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure are included in Logistic Regression model, firth correction will be applied if quasi-complete separation of data points is detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 29||||=0.268
71833744|NCT04714320|143171965|SUPERIORITY||||||=|0.702||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.702
71833745|NCT04714320|143171965|SUPERIORITY||||||=|0.885||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 36||||=0.885
71833746|NCT04714320|143171965|SUPERIORITY||||||=|0.066||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.066
71833747|NCT04714320|143171965|SUPERIORITY||||||=|0.783||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 43||||=0.783
71833748|NCT04714320|143171965|SUPERIORITY||||||=|0.456||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.456
71890615|NCT00619957|143302872|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.1408|TWO_SIDED|95.0|-0.19|1.34|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.34|-0.19|0.1408
71661436|NCT01193127|142836551|SUPERIORITY_OR_OTHER|||||||0.148||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.148
71740046|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.7529|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7529
71740047|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740048|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740049|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.5216
71740050|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740051|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740052|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.1078|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1078
71740053|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740054|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740055|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.1280
71740056|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71661437|NCT01193127|142836551|SUPERIORITY_OR_OTHER|||||||0.156||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.156
71833749|NCT04714320|143171965|SUPERIORITY||||||=|0.102||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 50||||=0.102
71833750|NCT04714320|143171965|SUPERIORITY||||||=|0.668||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.668
71833751|NCT04714320|143171965|SUPERIORITY||||||=|0.454||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 57||||=0.454
71833752|NCT04714320|143171965|SUPERIORITY||||||=|0.044||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.044
71833753|NCT04714320|143171965|SUPERIORITY||||||=|0.704||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 64||||=0.704
71833754|NCT04714320|143171965|SUPERIORITY||||||=|0.878||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.878
71661438|NCT01193127|142836551|SUPERIORITY_OR_OTHER|||||||0.381||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.381
71833755|NCT04714320|143171965|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 71||||=0.681
71833756|NCT04714320|143171965|SUPERIORITY||||||=|0.199||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.199
71661439|NCT01193127|142836552|SUPERIORITY_OR_OTHER|||||||0.646||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.646
71661440|NCT01193127|142836552|SUPERIORITY_OR_OTHER|||||||0.95||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.950
71833757|NCT04714320|143171965|SUPERIORITY||||||=|0.602||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 78||||=0.602
71833758|NCT04714320|143171965|SUPERIORITY||||||=|0.135||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.135
71833759|NCT04714320|143171965|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 85||||=0.407
71833760|NCT04714320|143171965|SUPERIORITY||||||=|0.795||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.795
71833761|NCT04714320|143171965|SUPERIORITY||||||=|0.036||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 92||||=0.036
71833762|NCT04714320|143171965|SUPERIORITY||||||=|0.915||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.915
71833763|NCT04714320|143171965|SUPERIORITY||||||=|0.957||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 106||||=0.957
71833764|NCT04714320|143171965|SUPERIORITY||||||=|0.804||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.804
71775262|NCT01675427|143051076|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0920
71775263|NCT01675427|143051076|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0781
71775264|NCT01675427|143051076|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4795
71775265|NCT01675427|143051076|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3069
71775266|NCT01675427|143051077|SUPERIORITY_OR_OTHER|||||||0.5216|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5216
71775267|NCT01675427|143051077|SUPERIORITY_OR_OTHER|||||||0.3419|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3419
71775268|NCT01675427|143051077|SUPERIORITY_OR_OTHER|||||||0.7586|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.7586
71775269|NCT01675427|143051077|SUPERIORITY_OR_OTHER|||||||0.1351|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1351
71775270|NCT01675427|143051077|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
71775271|NCT01675427|143051077|SUPERIORITY_OR_OTHER|||||||0.3921|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.3921
71775272|NCT01675427|143051078|SUPERIORITY_OR_OTHER|||||||0.8537|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8537
71775273|NCT01675427|143051078|SUPERIORITY_OR_OTHER|||||||0.0763|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0763
71833765|NCT04714320|143171965|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 120||||=0.775
71896342|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|5.268||||0.006|TWO_SIDED|95.0|1.615|17.187||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.187|1.615|0.006
71775274|NCT01675427|143051078|SUPERIORITY_OR_OTHER|||||||0.2432|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2432
71775275|NCT01675427|143051078|SUPERIORITY_OR_OTHER|||||||0.4247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4247
71775276|NCT01675427|143051078|SUPERIORITY_OR_OTHER|||||||0.4884|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4884
71775277|NCT01675427|143051078|SUPERIORITY_OR_OTHER|||||||0.6119|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6119
71775278|NCT01675427|143051079|SUPERIORITY_OR_OTHER|||||||0.2416|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2416
71775279|NCT01675427|143051079|SUPERIORITY_OR_OTHER|||||||0.2671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2671
71775280|NCT01675427|143051079|SUPERIORITY_OR_OTHER|||||||0.4619|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.4619
71775281|NCT01675427|143051079|SUPERIORITY_OR_OTHER|||||||0.8364|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.8364
71775282|NCT01675427|143051079|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2386
71775283|NCT01675427|143051079|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2887
71775284|NCT01675427|143051080|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0049
71775285|NCT01675427|143051081|SUPERIORITY_OR_OTHER|||||||0.5651|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.5651
71775286|NCT01675427|143051082|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.0420
71775287|NCT01675427|143051083|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||||||0.4545
71775288|NCT01675427|143051084|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71833766|NCT04714320|143171965|SUPERIORITY||||||=|0.801||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.801
71775289|NCT01675427|143051085|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775290|NCT01675427|143051086|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775291|NCT01675427|143051087|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775292|NCT01675427|143051088|SUPERIORITY_OR_OTHER|||||||0.5468|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.5468
71775293|NCT01675427|143051089|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0020
71775294|NCT01675427|143051090|SUPERIORITY_OR_OTHER|||||||0.1623|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.1623
71775295|NCT01675427|143051091|SUPERIORITY_OR_OTHER|||||||0.0663|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0663
71775296|NCT01675427|143051092|SUPERIORITY_OR_OTHER|||||||0.2617|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.2617
71775297|NCT01675427|143051093|SUPERIORITY_OR_OTHER|||||||0.0526|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0526
71775298|NCT01675427|143051094|SUPERIORITY_OR_OTHER|||||||0.7918|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.7918
71775299|NCT01675427|143051095|SUPERIORITY_OR_OTHER|||||||0.0842|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||||||0.0842
71775300|NCT01675427|143051096|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775301|NCT01675427|143051097|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775302|NCT01675427|143051098|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775303|NCT01675427|143051099|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775304|NCT01675427|143051100|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71775305|NCT01675427|143051100|SUPERIORITY_OR_OTHER|||||||0.2887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2887
71775306|NCT01675427|143051100|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
71775307|NCT01675427|143051100|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1634
71775308|NCT01675427|143051100|SUPERIORITY_OR_OTHER|||||||0.8956|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8956
71775309|NCT01675427|143051100|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775310|NCT01675427|143051101|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71775311|NCT01675427|143051101|SUPERIORITY_OR_OTHER|||||||0.0145|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0145
71775312|NCT01675427|143051101|SUPERIORITY_OR_OTHER|||||||0.1027|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1027
71775313|NCT01675427|143051101|SUPERIORITY_OR_OTHER|||||||0.5998|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5998
71775314|NCT01675427|143051101|SUPERIORITY_OR_OTHER|||||||0.2935|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2935
71775315|NCT01675427|143051101|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0039
71775316|NCT01675427|143051102|SUPERIORITY_OR_OTHER|||||||0.1981|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1981
71775317|NCT01675427|143051102|SUPERIORITY_OR_OTHER|||||||0.1616|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1616
71775318|NCT01675427|143051102|SUPERIORITY_OR_OTHER|||||||0.1192|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1192
71775319|NCT01675427|143051102|SUPERIORITY_OR_OTHER|||||||0.4485|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4485
71775320|NCT01675427|143051102|SUPERIORITY_OR_OTHER|||||||0.1525|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1525
71775321|NCT01675427|143051102|SUPERIORITY_OR_OTHER|||||||0.7262|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7262
71775322|NCT01675427|143051103|SUPERIORITY_OR_OTHER|||||||0.0911|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0911
71740057|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71775323|NCT01675427|143051103|SUPERIORITY_OR_OTHER|||||||0.4674|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4674
71775324|NCT01675427|143051103|SUPERIORITY_OR_OTHER|||||||0.1604|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1604
71890616|NCT00619957|143302873|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07||||0.0129|TWO_SIDED|95.0|0.23|1.92|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.92|0.23|0.0129
71740058|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0291
71740059|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740060|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740061|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.0729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0729
71740062|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740063|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740064|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.0271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0271
71740065|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740066|NCT00445770|142992930|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71775325|NCT01675427|143051103|SUPERIORITY_OR_OTHER|||||||0.5937|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5937
71775326|NCT01675427|143051103|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3830
71775327|NCT01675427|143051103|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0507
71775328|NCT01675427|143051104|SUPERIORITY_OR_OTHER|||||||0.8686|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8686
71740067|NCT00445770|142992930|SUPERIORITY_OR_OTHER|||||||0.0453|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0453
71740068|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740069|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740070|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.7488|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.7488
71740071|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740072|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740073|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.5680
71740074|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740075|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740076|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.9241|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9241
71740077|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740078|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740079|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.7146|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.7146
71740080|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740081|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
71661441|NCT01193127|142836552|SUPERIORITY_OR_OTHER|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.160
71661442|NCT01193127|142836553|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71661443|NCT01193127|142836553|SUPERIORITY_OR_OTHER|||||||0.667||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.667
71661444|NCT01193127|142836553|SUPERIORITY_OR_OTHER|||||||0.303||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.303
71661445|NCT01193127|142836554|SUPERIORITY_OR_OTHER|||||||0.789||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.789
71661446|NCT01193127|142836554|SUPERIORITY_OR_OTHER|||||||0.977||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.977
71740082|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.6574
71661447|NCT01193127|142836554|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
71740083|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740084|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0004
71740085|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.2936|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.2936
71740086|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740087|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0005
71740088|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2179
71661448|NCT01193127|142836555|SUPERIORITY_OR_OTHER|||||||0.632||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.632
71661449|NCT01193127|142836555|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
71661450|NCT01193127|142836555|SUPERIORITY_OR_OTHER|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.336
71661451|NCT01193127|142836556|SUPERIORITY_OR_OTHER|||||||0.528||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.528
71661452|NCT01193127|142836556|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
71661453|NCT01193127|142836556|SUPERIORITY_OR_OTHER|||||||0.353||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.353
71740089|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740090|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740091|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.3704|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.3704
71740092|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740093|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740094|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.8047|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.8047
71740095|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740096|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740097|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.5277|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5277
71740098|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71661454|NCT01193127|142836557|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.463
71740099|NCT00445770|142992931|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740100|NCT00445770|142992931|SUPERIORITY_OR_OTHER|||||||0.9371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9371
71740101|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0027
71740102|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.0015
71740103|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.8875|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8875
71740104|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0015
71740105|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0011
71740106|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.9694|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.9694
71740107|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0020
71740108|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.0005
71740109|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.7271|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.7271
71740110|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0235|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0235
71740111|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0061
71661455|NCT01193127|142836557|SUPERIORITY_OR_OTHER|||||||0.406||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.406
71740112|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.6427|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.6427
71740113|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0036
71740114|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0029
71740115|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.9713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.9713
71740116|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
71740117|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0060
71740118|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.9762|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.9762
71740119|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0554|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0554
71740120|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0181|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0181
71740121|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.6642|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6642
71740122|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0073
71740123|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0290
71740124|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.5919|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.5919
71740125|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0371|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0371
71740126|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0346
71740127|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.9955|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.9955
71740128|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0187|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0187
71740129|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0645|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0645
71740130|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5920
71661456|NCT01193127|142836557|SUPERIORITY_OR_OTHER|||||||0.245||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.245
71833767|NCT04714320|143171965|SUPERIORITY||||||=|0.329||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 148||||=0.329
71833768|NCT04714320|143171965|SUPERIORITY||||||=|0.882||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.882
71833769|NCT04714320|143171965|SUPERIORITY||||||=|0.235||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg at Day 169||||=0.235
71833770|NCT04714320|143171965|SUPERIORITY||||||=|0.505||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.505
71833771|NCT04714320|143171965|SUPERIORITY||||||=|0.436||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 8||||=0.436
71661457|NCT01193127|142836558|SUPERIORITY_OR_OTHER|||||||0.945||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.945
71833772|NCT04714320|143171965|SUPERIORITY||||||=|0.637||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.637
71833773|NCT04714320|143171965|SUPERIORITY||||||=|0.254||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 15||||=0.254
71833774|NCT04714320|143171965|SUPERIORITY||||||=|0.848||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.848
71661458|NCT01193127|142836558|SUPERIORITY_OR_OTHER|||||||0.438||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.438
71661459|NCT01193127|142836558|SUPERIORITY_OR_OTHER|||||||0.596||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.596
71833775|NCT04714320|143171965|SUPERIORITY||||||=|0.24||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 22||||=0.240
71833776|NCT04714320|143171965|SUPERIORITY||||||=|0.382||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.382
71833777|NCT04714320|143171965|SUPERIORITY||||||=|0.935||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 29||||=0.935
71833778|NCT04714320|143171965|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.278
71833779|NCT04714320|143171965|SUPERIORITY||||||=|0.211||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 36||||=0.211
71833780|NCT04714320|143171965|SUPERIORITY||||||=|0.562||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.562
71833781|NCT04714320|143171965|SUPERIORITY||||||=|0.25||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 43||||=0.250
71833782|NCT04714320|143171965|SUPERIORITY||||||=|0.114||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.114
71890617|NCT00619957|143302874|SUPERIORITY_OR_OTHER||LS Mean Difference|2.31|||<|0.0001|TWO_SIDED|95.0|1.35|3.26|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.26|1.35|<0.0001
71890618|NCT00619957|143302875|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|||<|0.0001|TWO_SIDED|95.0|1.22|3.08|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.08|1.22|<0.0001
71740131|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.0095|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0095
71775329|NCT01675427|143051104|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.3135
71740132|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.2112|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.2112
71740133|NCT00445770|142992932|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1649
71740134|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740135|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740136|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.8972|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8972
71740137|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740138|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740139|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.3736|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.3736
71775330|NCT01675427|143051104|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0578
71775331|NCT01675427|143051104|SUPERIORITY_OR_OTHER|||||||0.5833|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5833
71740140|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71775332|NCT01675427|143051104|SUPERIORITY_OR_OTHER|||||||0.161|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1610
71775333|NCT01675427|143051104|SUPERIORITY_OR_OTHER|||||||0.2925|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2925
71775334|NCT01675427|143051105|SUPERIORITY_OR_OTHER|||||||0.3709|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3709
71740141|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740142|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.9324|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.9324
71740143|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740144|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740145|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.8982|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.8982
71740146|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740147|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0007
71740148|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.3180
71740149|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740150|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0011
71740151|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.3302|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.3302
71740152|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740153|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.0002
71740154|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.6563|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.6563
71740155|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740156|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71833783|NCT04714320|143171965|SUPERIORITY||||||=|0.55||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 50||||=0.550
71833784|NCT04714320|143171965|SUPERIORITY||||||=|0.423||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.423
71833785|NCT04714320|143171965|SUPERIORITY||||||=|0.422||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 57||||=0.422
71833786|NCT04714320|143171965|SUPERIORITY||||||=|0.073||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.073
71833787|NCT04714320|143171965|SUPERIORITY||||||=|0.278||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 64||||=0.278
71833788|NCT04714320|143171965|SUPERIORITY||||||=|0.338||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.338
71890619|NCT00619957|143302876|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.6|||<|0.0001|TWO_SIDED|95.0|-51.52|-35.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-35.67|-51.52|<0.0001
71740157|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.8894|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.8894
71740158|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740159|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71833789|NCT04714320|143171965|SUPERIORITY||||||=|0.969||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 71||||=0.969
71833790|NCT04714320|143171965|SUPERIORITY||||||=|0.489||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.489
71833791|NCT04714320|143171965|SUPERIORITY||||||=|0.156||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 78||||=0.156
71833792|NCT04714320|143171965|SUPERIORITY||||||=|0.389||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.389
71833793|NCT04714320|143171965|SUPERIORITY||||||=|0.775||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 85||||=0.775
71833794|NCT04714320|143171965|SUPERIORITY||||||=|0.437||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.437
71775335|NCT01675427|143051105|SUPERIORITY_OR_OTHER|||||||0.2054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2054
71775336|NCT01675427|143051105|SUPERIORITY_OR_OTHER|||||||0.8457|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.8457
71775337|NCT01675427|143051105|SUPERIORITY_OR_OTHER|||||||0.3492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3492
71740160|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.7826|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7826
71740161|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740162|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0003
71740163|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.5343|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.5343
71740164|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71775338|NCT01675427|143051105|SUPERIORITY_OR_OTHER|||||||0.2846|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2846
71775339|NCT01675427|143051105|SUPERIORITY_OR_OTHER|||||||0.2646|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.2646
71740165|NCT00445770|142992933|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740166|NCT00445770|142992933|SUPERIORITY_OR_OTHER|||||||0.9313|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.9313
71775340|NCT01675427|143051106|SUPERIORITY_OR_OTHER|||||||0.5348|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.5348
71775341|NCT01675427|143051106|SUPERIORITY_OR_OTHER|||||||0.5469|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5469
71775342|NCT01675427|143051106|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0463
71775343|NCT01675427|143051106|SUPERIORITY_OR_OTHER|||||||0.9393|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.9393
71661460|NCT01193127|142836559|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.811
71775344|NCT01675427|143051106|SUPERIORITY_OR_OTHER|||||||0.3404|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3404
71775345|NCT01675427|143051106|SUPERIORITY_OR_OTHER|||||||0.4237|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4237
71775346|NCT01675427|143051107|SUPERIORITY_OR_OTHER|||||||0.251|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.2510
71775347|NCT01675427|143051107|SUPERIORITY_OR_OTHER|||||||0.2943|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2943
71775348|NCT01675427|143051107|SUPERIORITY_OR_OTHER|||||||0.0478|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0478
71775349|NCT01675427|143051107|SUPERIORITY_OR_OTHER|||||||0.5387|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5387
71775350|NCT01675427|143051107|SUPERIORITY_OR_OTHER|||||||0.3878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3878
71775351|NCT01675427|143051107|SUPERIORITY_OR_OTHER|||||||0.0748|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0748
71661461|NCT01193127|142836559|SUPERIORITY_OR_OTHER|||||||0.552||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.552
71740167|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740168|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740169|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.8044|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.8044
71740170|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740171|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.0003
71740172|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4652
71740173|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71661462|NCT01193127|142836559|SUPERIORITY_OR_OTHER|||||||0.549||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.549
71661463|NCT01193127|142836560|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.173
71661464|NCT01193127|142836560|SUPERIORITY_OR_OTHER|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.362
71661465|NCT01193127|142836560|SUPERIORITY_OR_OTHER|||||||0.559|||||||Cochran-Mantel-Haenszel|||||||0.559
71661466|NCT01193127|142836561|SUPERIORITY_OR_OTHER|||||||0.681||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.681
71661467|NCT01193127|142836561|SUPERIORITY_OR_OTHER|||||||0.429||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.429
71661468|NCT01193127|142836561|SUPERIORITY_OR_OTHER|||||||0.306||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.306
71661469|NCT01193127|142836562|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
71661470|NCT01193127|142836562|SUPERIORITY_OR_OTHER|||||||0.602||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.602
71661471|NCT01193127|142836562|SUPERIORITY_OR_OTHER|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||0.290
71661472|NCT01193127|142836563|SUPERIORITY_OR_OTHER|||||||0.244||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.244
71661473|NCT01193127|142836563|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.122
71661474|NCT01193127|142836563|SUPERIORITY_OR_OTHER|||||||0.79||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.790
71661475|NCT01193127|142836564|SUPERIORITY_OR_OTHER|||||||0.752||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.752
71661476|NCT01193127|142836564|SUPERIORITY_OR_OTHER|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.355
71661477|NCT01193127|142836564|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
71661478|NCT01193127|142836565|SUPERIORITY_OR_OTHER|||||||0.228||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.228
71661479|NCT01193127|142836565|SUPERIORITY_OR_OTHER|||||||0.564||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.564
71661480|NCT01193127|142836565|SUPERIORITY_OR_OTHER|||||||0.755||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.755
71833795|NCT04714320|143171965|SUPERIORITY||||||=|0.618|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 92||||=0.618
71833796|NCT04714320|143171965|SUPERIORITY||||||=|0.079||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.079
71833797|NCT04714320|143171965|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 106||||=0.349
71833798|NCT04714320|143171965|SUPERIORITY||||||=|0.58||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.580
71833799|NCT04714320|143171965|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 120||||=0.106
71833800|NCT04714320|143171965|SUPERIORITY||||||=|0.955||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.955
71833801|NCT04714320|143171965|SUPERIORITY||||||=|0.134||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 148||||=0.134
71775352|NCT01675427|143051108|SUPERIORITY_OR_OTHER|||||||0.9887|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.9887
71775353|NCT01675427|143051108|SUPERIORITY_OR_OTHER|||||||0.5507|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.5507
71661481|NCT01193127|142836566|SUPERIORITY_OR_OTHER|||||||0.018||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.018
71775354|NCT01675427|143051108|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0175
71775355|NCT01675427|143051108|SUPERIORITY_OR_OTHER|||||||0.2246|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2246
71775356|NCT01675427|143051108|SUPERIORITY_OR_OTHER|||||||0.3519|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3519
71775357|NCT01675427|143051108|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.7140
71775358|NCT01675427|143051109|SUPERIORITY_OR_OTHER|||||||0.8622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.8622
71775359|NCT01675427|143051109|SUPERIORITY_OR_OTHER|||||||0.1622|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1622
71775360|NCT01675427|143051109|SUPERIORITY_OR_OTHER|||||||0.2566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2566
71775361|NCT01675427|143051109|SUPERIORITY_OR_OTHER|||||||0.1574|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1574
71775362|NCT01675427|143051109|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5784
71661482|NCT01193127|142836566|SUPERIORITY_OR_OTHER|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.292
71661483|NCT01193127|142836566|SUPERIORITY_OR_OTHER|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.298
71661484|NCT01193127|142836567|SUPERIORITY_OR_OTHER|||||||0.271||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.271
71661485|NCT01193127|142836567|SUPERIORITY_OR_OTHER|||||||0.345||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.345
71661486|NCT01193127|142836567|SUPERIORITY_OR_OTHER|||||||0.096||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.096
71775363|NCT01675427|143051109|SUPERIORITY_OR_OTHER|||||||0.6603|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.6603
71775364|NCT01675427|143051110|SUPERIORITY_OR_OTHER|||||||0.0605|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0605
71775365|NCT01675427|143051110|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0899
71775366|NCT01675427|143051110|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0634
71775367|NCT01675427|143051110|SUPERIORITY_OR_OTHER|||||||0.6165|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.6165
71775368|NCT01675427|143051110|SUPERIORITY_OR_OTHER|||||||0.1649|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.1649
71775369|NCT01675427|143051110|SUPERIORITY_OR_OTHER|||||||0.9159|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9159
71775370|NCT01675427|143051111|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.7454
71775371|NCT01675427|143051111|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0016
71775372|NCT01675427|143051111|SUPERIORITY_OR_OTHER|||||||0.5261|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5261
71775373|NCT01675427|143051111|SUPERIORITY_OR_OTHER|||||||0.3422|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3422
71775374|NCT01675427|143051111|SUPERIORITY_OR_OTHER|||||||0.9026|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.9026
71775375|NCT01675427|143051112|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0017
71775376|NCT01675427|143051112|SUPERIORITY_OR_OTHER|||||||0.8864|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.8864
71775377|NCT01675427|143051112|SUPERIORITY_OR_OTHER|||||||0.0291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0291
71890620|NCT00619957|143302877|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.72|||<|0.0001|TWO_SIDED|95.0|-58.01|-31.43|||ANOVA|Fixed effects for treatment and pooled center||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-31.43|-58.01|<0.0001
71890621|NCT00619957|143302878|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.33|||<|0.0001|TWO_SIDED|95.0|-55.99|-28.67|||ANOVA|Fixed effects for treatment and pooled centers.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-28.67|-55.99|<0.0001
71890622|NCT00619957|143302879|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.55|||<|0.0001|TWO_SIDED|95.0|-59.38|-33.72|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.72|-59.38|<0.0001
71890623|NCT00619957|143302880|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.15|||<|0.0001|TWO_SIDED|95.0|-57.01|-33.29|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-33.29|-57.01|<0.0001
71890624|NCT00619957|143302881|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.88|||<|0.0001|TWO_SIDED|95.0|-23.43|-8.32|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-8.32|-23.43|<0.0001
71890625|NCT00619957|143302882|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-31.08|-12.91|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-12.91|-31.08|<0.0001
71661487|NCT01193127|142836568|SUPERIORITY_OR_OTHER|||||||0.32||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.320
71661488|NCT01193127|142836568|SUPERIORITY_OR_OTHER|||||||0.39||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.390
71661489|NCT01193127|142836568|SUPERIORITY_OR_OTHER|||||||0.23||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.230
71661490|NCT01193127|142836569|SUPERIORITY_OR_OTHER|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.778
71661491|NCT01193127|142836569|SUPERIORITY_OR_OTHER|||||||0.348||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.348
71661492|NCT01193127|142836569|SUPERIORITY_OR_OTHER|||||||0.477||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.477
71890626|NCT00619957|143302883|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.96|||<|0.0001|TWO_SIDED|95.0|-30.75|-13.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-13.17|-30.75|<0.0001
71890627|NCT00619957|143302884|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.11||||0.0012|TWO_SIDED|95.0|-24.2|-6.02|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-6.02|-24.20|0.0012
71661493|NCT01193127|142836570|SUPERIORITY_OR_OTHER|||||||0.374||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.374
71661494|NCT01193127|142836570|SUPERIORITY_OR_OTHER|||||||0.265||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.265
71661495|NCT01193127|142836570|SUPERIORITY_OR_OTHER|||||||0.555||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.555
71833802|NCT04714320|143171965|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.933
71740174|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740175|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.5612|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.5612
71740176|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
71740177|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.0002
71740178|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.9749|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.9749
71775378|NCT01675427|143051112|SUPERIORITY_OR_OTHER|||||||0.5472|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5472
71775379|NCT01675427|143051112|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||1.000
71775380|NCT01675427|143051112|SUPERIORITY_OR_OTHER|||||||0.1148|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.1148
71775381|NCT01675427|143051113|SUPERIORITY_OR_OTHER|||||||0.4207|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.4207
71775382|NCT01675427|143051113|SUPERIORITY_OR_OTHER|||||||0.0566|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0566
71775383|NCT01675427|143051113|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1211
71775384|NCT01675427|143051113|SUPERIORITY_OR_OTHER|||||||0.3772|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3772
71890628|NCT00619957|143302885|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.37||||0.0003|TWO_SIDED|95.0|-25.24|-7.49|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-7.49|-25.24|0.0003
71740179|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0001
71775385|NCT01675427|143051113|SUPERIORITY_OR_OTHER|||||||0.4023|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.4023
71775386|NCT01675427|143051114|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71775387|NCT01675427|143051114|SUPERIORITY_OR_OTHER|||||||0.2132|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2132
71775388|NCT01675427|143051114|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
71775389|NCT01675427|143051114|SUPERIORITY_OR_OTHER|||||||0.3031|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3031
71740180|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.0004
71740181|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.729|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.7290
71740182|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740183|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.0003
71775390|NCT01675427|143051114|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9550
71775391|NCT01675427|143051114|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775392|NCT01675427|143051115|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71775393|NCT01675427|143051115|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1890
71775394|NCT01675427|143051115|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5793
71833803|NCT04714320|143171965|SUPERIORITY||||||=|0.502||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 90 mmHg at Day 169||||=0.502
71890629|NCT00619957|143302886|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.64|||<|0.0001|TWO_SIDED|95.0|-19.29|-11.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-11.99|-19.29|<0.0001
71661496|NCT01193127|142836571|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.031
71661497|NCT01193127|142836571|SUPERIORITY_OR_OTHER|||||||0.059||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.059
71740184|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.5004|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.5004
71740185|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740186|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740187|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.5727|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.5727
71740188|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740189|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740190|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.6713|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.6713
71740191|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740192|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.0001
71740193|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.7663|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.7663
71740194|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740195|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.0002
71740196|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.7073|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.7073
71661498|NCT01193127|142836571|SUPERIORITY_OR_OTHER|||||||0.472||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.472
71740197|NCT00445770|142992934|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740198|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.0001
71740199|NCT00445770|142992934|SUPERIORITY_OR_OTHER|||||||0.7973|TWO_SIDED|||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.7973
71740200|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71740201|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71740202|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.1053|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.1053
71740203|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71740204|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71740205|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0144|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0144
71740206|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71740207|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71740208|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.1851|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.1851
71740209|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71740210|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0001
71740211|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.2883|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.2883
71740212|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71740213|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.0007
71740214|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.2221|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.2221
71740215|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71775395|NCT01675427|143051115|SUPERIORITY_OR_OTHER|||||||0.0847|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0847
71775396|NCT01675427|143051115|SUPERIORITY_OR_OTHER|||||||0.5506|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5506
71775397|NCT01675427|143051115|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0020
71775398|NCT01675427|143051116|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
71775399|NCT01675427|143051116|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0061
71833804|NCT04714320|143171965|SUPERIORITY||||||=|0.653||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.653
71661499|NCT01193127|142836572|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
71740216|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0147
71740217|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0201|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0201
71740218|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71775400|NCT01675427|143051116|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
71740219|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0036
71740220|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0789
71740221|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71740222|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0008
71740223|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.1903|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1903
71740224|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71740225|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0048
71740226|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.1059|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1059
71775401|NCT01675427|143051116|SUPERIORITY_OR_OTHER|||||||0.3885|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3885
71775402|NCT01675427|143051116|SUPERIORITY_OR_OTHER|||||||0.3597|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3597
71775403|NCT01675427|143051116|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775404|NCT01675427|143051117|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71775405|NCT01675427|143051117|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0005
71775406|NCT01675427|143051117|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0110
71775407|NCT01675427|143051117|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0980
71833805|NCT04714320|143171965|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 8||||=0.816
71661500|NCT01193127|142836572|SUPERIORITY_OR_OTHER|||||||0.169||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.169
71775408|NCT01675427|143051117|SUPERIORITY_OR_OTHER|||||||0.2264|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2264
71775409|NCT01675427|143051117|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775410|NCT01675427|143051118|SUPERIORITY_OR_OTHER|||||||0.0098|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0098
71775411|NCT01675427|143051118|SUPERIORITY_OR_OTHER|||||||0.6291|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.6291
71775412|NCT01675427|143051118|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
71775413|NCT01675427|143051118|SUPERIORITY_OR_OTHER|||||||0.5588|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5588
71775414|NCT01675427|143051118|SUPERIORITY_OR_OTHER|||||||0.9932|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9932
71775415|NCT01675427|143051118|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775416|NCT01675427|143051119|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0007
71775417|NCT01675427|143051119|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0020
71775418|NCT01675427|143051119|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0013
71775419|NCT01675427|143051119|SUPERIORITY_OR_OTHER|||||||0.7166|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7166
71775420|NCT01675427|143051119|SUPERIORITY_OR_OTHER|||||||0.3217|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3217
71775421|NCT01675427|143051119|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775422|NCT01675427|143051120|SUPERIORITY_OR_OTHER|||||||0.1894|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.1894
71775423|NCT01675427|143051120|SUPERIORITY_OR_OTHER|||||||0.0054|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0054
71775424|NCT01675427|143051120|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
71775425|NCT01675427|143051120|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.5360
71775426|NCT01675427|143051120|SUPERIORITY_OR_OTHER|||||||0.2185|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2185
71775427|NCT01675427|143051120|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775428|NCT01675427|143051121|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
71775429|NCT01675427|143051121|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0003
71775430|NCT01675427|143051121|SUPERIORITY_OR_OTHER|||||||0.0106|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0106
71775431|NCT01675427|143051121|SUPERIORITY_OR_OTHER|||||||0.7821|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7821
71775432|NCT01675427|143051121|SUPERIORITY_OR_OTHER|||||||0.2372|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2372
71775433|NCT01675427|143051121|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775434|NCT01675427|143051122|SUPERIORITY_OR_OTHER|||||||0.0688|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0688
71775435|NCT01675427|143051122|SUPERIORITY_OR_OTHER|||||||0.4367|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.4367
71775436|NCT01675427|143051122|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||< 0.0001
71775437|NCT01675427|143051122|SUPERIORITY_OR_OTHER|||||||0.1951|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1951
71775438|NCT01675427|143051122|SUPERIORITY_OR_OTHER|||||||0.2927|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.2927
71661501|NCT01193127|142836572|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.310
71661502|NCT01193127|142836573|SUPERIORITY_OR_OTHER|||||||0.075||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.075
71661503|NCT01193127|142836573|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.005
71740227|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71775439|NCT01675427|143051122|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0013
71775440|NCT01675427|143051123|SUPERIORITY_OR_OTHER|||||||0.0247|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0247
71775441|NCT01675427|143051123|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0034
71775442|NCT01675427|143051123|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0017
71775443|NCT01675427|143051123|SUPERIORITY_OR_OTHER|||||||0.3346|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.3346
71775444|NCT01675427|143051123|SUPERIORITY_OR_OTHER|||||||0.3215|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.3215
71775445|NCT01675427|143051123|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0003
71775446|NCT01675427|143051124|SUPERIORITY_OR_OTHER|||||||0.3609|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.3609
71775447|NCT01675427|143051124|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0018
71661504|NCT01193127|142836573|SUPERIORITY_OR_OTHER|||||||0.078||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.078
71661505|NCT01193127|142836574|SUPERIORITY_OR_OTHER|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.226
71661506|NCT01193127|142836574|SUPERIORITY_OR_OTHER|||||||0.357||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.357
71661507|NCT01193127|142836574|SUPERIORITY_OR_OTHER|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.291
71740228|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0018
71740229|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.2589
71740230|NCT00445770|142992935|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71775448|NCT01675427|143051124|SUPERIORITY_OR_OTHER|||||||0.0356|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0356
71775449|NCT01675427|143051124|SUPERIORITY_OR_OTHER|||||||0.7044|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.7044
71775450|NCT01675427|143051124|SUPERIORITY_OR_OTHER|||||||0.8578|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.8578
71775451|NCT01675427|143051124|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0076
71775452|NCT01675427|143051125|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0002
71775453|NCT01675427|143051125|SUPERIORITY_OR_OTHER|||||||0.2017|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2017
71775454|NCT01675427|143051125|SUPERIORITY_OR_OTHER|||||||0.5878|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.5878
71775455|NCT01675427|143051125|SUPERIORITY_OR_OTHER|||||||0.4144|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4144
71775456|NCT01675427|143051125|SUPERIORITY_OR_OTHER|||||||0.4492|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.4492
71775457|NCT01675427|143051125|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||< 0.0001
71775458|NCT01675427|143051126|SUPERIORITY_OR_OTHER|||||||0.0671|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0671
71775459|NCT01675427|143051126|SUPERIORITY_OR_OTHER|||||||0.1009|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.1009
71775460|NCT01675427|143051126|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0635
71661508|NCT01193127|142836575|SUPERIORITY_OR_OTHER|||||||0.172||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.172
71661509|NCT01193127|142836575|SUPERIORITY_OR_OTHER|||||||0.547||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.547
71775461|NCT01675427|143051126|SUPERIORITY_OR_OTHER|||||||0.4162|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.4162
71775462|NCT01675427|143051126|SUPERIORITY_OR_OTHER|||||||0.9305|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.9305
71775463|NCT01675427|143051126|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0041
71775464|NCT01675427|143051127|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||0.0059
71775465|NCT01675427|143051127|SUPERIORITY_OR_OTHER|||||||0.2808|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.2808
71775466|NCT01675427|143051127|SUPERIORITY_OR_OTHER|||||||0.2401|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.2401
71775467|NCT01675427|143051127|SUPERIORITY_OR_OTHER|||||||0.2993|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.2993
71775468|NCT01675427|143051127|SUPERIORITY_OR_OTHER|||||||0.5529|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes||||0.5529
71775469|NCT01675427|143051127|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes||||0.0005
71890630|NCT00619957|143302887|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-25.61|-16.59|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.59|-25.61|<0.0001
71661510|NCT01193127|142836575|SUPERIORITY_OR_OTHER|||||||0.921||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.921
71775470|NCT01675427|143051128|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71661511|NCT01193127|142836576|SUPERIORITY_OR_OTHER|||||||0.701||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.701
71661512|NCT01193127|142836576|SUPERIORITY_OR_OTHER|||||||0.089||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.089
71775471|NCT01675427|143051128|SUPERIORITY_OR_OTHER|||||||0.3572|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3572
71775472|NCT01675427|143051128|SUPERIORITY_OR_OTHER|||||||0.2041|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2041
71775473|NCT01675427|143051128|SUPERIORITY_OR_OTHER|||||||0.0467|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0467
71775474|NCT01675427|143051128|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0525
71775475|NCT01675427|143051128|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775476|NCT01675427|143051129|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71775477|NCT01675427|143051129|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
71775478|NCT01675427|143051129|SUPERIORITY_OR_OTHER|||||||0.5275|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5275
71775479|NCT01675427|143051129|SUPERIORITY_OR_OTHER|||||||0.6593|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.6593
71775480|NCT01675427|143051129|SUPERIORITY_OR_OTHER|||||||0.0372|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0372
71775481|NCT01675427|143051129|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775482|NCT01675427|143051130|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71775483|NCT01675427|143051130|SUPERIORITY_OR_OTHER|||||||0.3857|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.3857
71775484|NCT01675427|143051130|SUPERIORITY_OR_OTHER|||||||0.2356|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.2356
71833806|NCT04714320|143171965|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.184
71833807|NCT04714320|143171965|SUPERIORITY||||||=|0.765||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 15||||=0.765
71833808|NCT04714320|143171965|SUPERIORITY||||||=|0.009||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.009
71833809|NCT04714320|143171965|SUPERIORITY||||||=|0.578||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 22||||=0.578
71833810|NCT04714320|143171965|SUPERIORITY||||||=|0.725||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.725
71833811|NCT04714320|143171965|SUPERIORITY||||||=|0.287||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 29||||=0.287
71833812|NCT04714320|143171965|SUPERIORITY||||||=|0.705||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.705
71661513|NCT01193127|142836576|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.095
71833813|NCT04714320|143171965|SUPERIORITY||||||=|0.975||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 36||||=0.975
71890631|NCT00619957|143302888|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.39|||<|0.0001|TWO_SIDED|95.0|-27.8|-16.98|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.98|-27.80|<0.0001
71661514|NCT01193127|142836577|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.086
71661515|NCT01193127|142836577|SUPERIORITY_OR_OTHER|||||||0.092||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test|||||||0.092
71661516|NCT01193127|142836577|SUPERIORITY_OR_OTHER|||||||0.12||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.120
71833814|NCT04714320|143171965|SUPERIORITY||||||=|0.118||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.118
71833815|NCT04714320|143171965|SUPERIORITY||||||=|0.959||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 43||||=0.959
71833816|NCT04714320|143171965|SUPERIORITY||||||=|0.413||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.413
71833817|NCT04714320|143171965|SUPERIORITY||||||=|0.043||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 50||||=0.043
71833818|NCT04714320|143171965|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.849
71833819|NCT04714320|143171965|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 57||||=0.662
71775485|NCT01675427|143051130|SUPERIORITY_OR_OTHER|||||||0.7993|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.7993
71890632|NCT00619957|143302889|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.15|||<|0.0001|TWO_SIDED|95.0|-39.84|-16.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.47|-39.84|<0.0001
71661517|NCT01193127|142836578|SUPERIORITY_OR_OTHER|||||||0.626||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.626
71661518|NCT01193127|142836578|SUPERIORITY_OR_OTHER|||||||0.736||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.736
71661519|NCT01193127|142836578|SUPERIORITY_OR_OTHER|||||||0.725||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.725
71661520|NCT01193127|142836579|SUPERIORITY_OR_OTHER|||||||0.22||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.220
71661521|NCT01193127|142836579|SUPERIORITY_OR_OTHER|||||||0.903||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.903
71661522|NCT01193127|142836579|SUPERIORITY_OR_OTHER|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.463
71661523|NCT01193127|142836580|SUPERIORITY_OR_OTHER|||||||0.675||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.675
71661524|NCT01193127|142836580|SUPERIORITY_OR_OTHER|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|WIlcoxon rank-sum test|||||||0.825
71661525|NCT01193127|142836580|SUPERIORITY_OR_OTHER|||||||0.668||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||||||0.668
71661526|NCT01193127|142836581|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
71661527|NCT01193127|142836581|SUPERIORITY_OR_OTHER|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2066
71661528|NCT01193127|142836581|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5263
71661529|NCT01193127|142836582|SUPERIORITY_OR_OTHER|||||||0.4222||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4222
71661530|NCT01193127|142836582|SUPERIORITY_OR_OTHER|||||||0.2712||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.2712
71661531|NCT01193127|142836582|SUPERIORITY_OR_OTHER|||||||0.8819||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8819
71661532|NCT01193127|142836583|SUPERIORITY_OR_OTHER|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0510
71661533|NCT01193127|142836583|SUPERIORITY_OR_OTHER|||||||0.8084||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.8084
71661534|NCT01193127|142836583|SUPERIORITY_OR_OTHER|||||||0.1495||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1495
71661535|NCT01193127|142836584|SUPERIORITY_OR_OTHER|||||||0.4099||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.4099
71661536|NCT01193127|142836584|SUPERIORITY_OR_OTHER|||||||0.6499||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6499
71661537|NCT01193127|142836584|SUPERIORITY_OR_OTHER|||||||0.0765||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0765
71661538|NCT01193127|142836585|SUPERIORITY_OR_OTHER|||||||0.0688||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0688
71661539|NCT01193127|142836585|SUPERIORITY_OR_OTHER|||||||0.0314||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0314
71661540|NCT01193127|142836585|SUPERIORITY_OR_OTHER|||||||0.0775||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.0775
71661541|NCT01193127|142836586|SUPERIORITY_OR_OTHER|||||||0.5369||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.5369
71661542|NCT01193127|142836586|SUPERIORITY_OR_OTHER|||||||0.3763||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.3763
71661543|NCT01193127|142836586|SUPERIORITY_OR_OTHER|||||||0.6144||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.6144
71775486|NCT01675427|143051130|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2164
71890633|NCT00619957|143302890|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.25|||<|0.0001|TWO_SIDED|95.0|-37.63|-16.87|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||-16.87|-37.63|<0.0001
71890634|NCT00619957|143302891|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14||||0.8794|TWO_SIDED|95.0|-1.99|1.71|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.71|-1.99|0.8794
71890635|NCT00619957|143302892|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47||||0.6658|TWO_SIDED|95.0|-2.62|1.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.67|-2.62|0.6658
71661544|NCT01193127|142836587|SUPERIORITY_OR_OTHER|||||||0.1374||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.1374
71661545|NCT01193127|142836587|SUPERIORITY_OR_OTHER|||||||0.9146||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.9146
71661546|NCT01193127|142836587|SUPERIORITY_OR_OTHER|||||||0.7599||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA|||||||0.7599
71661547|NCT01193127|142836588|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71661548|NCT01193127|142836588|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71661549|NCT01193127|142836588|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71661550|NCT01193127|142836589|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
71661551|NCT01193127|142836589|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.647
71661552|NCT01193127|142836589|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
71775487|NCT01675427|143051130|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71661553|NCT01193127|142836590|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71661554|NCT01193127|142836590|SUPERIORITY_OR_OTHER|||||||0.335||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.335
71661555|NCT01193127|142836590|SUPERIORITY_OR_OTHER|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.317
71661556|NCT01193127|142836591|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71661557|NCT01193127|142836591|SUPERIORITY_OR_OTHER|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.559
71661558|NCT01193127|142836591|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||1.000
71661559|NCT01193127|142836592|SUPERIORITY_OR_OTHER|||||||0.824||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.824
71661560|NCT01193127|142836592|SUPERIORITY_OR_OTHER|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.476
71661561|NCT01193127|142836592|SUPERIORITY_OR_OTHER|||||||0.281||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.281
71775488|NCT01675427|143051131|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71890636|NCT00619957|143302893|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.784|TWO_SIDED|95.0|-2.39|1.81|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.81|-2.39|0.7840
71661562|NCT01193127|142836593|SUPERIORITY_OR_OTHER|||||||0.842||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.842
71661563|NCT01193127|142836593|SUPERIORITY_OR_OTHER|||||||0.619||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.619
71661564|NCT01193127|142836593|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
71661565|NCT01193127|142836594|SUPERIORITY_OR_OTHER|||||||0.773||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.773
71661566|NCT01193127|142836594|SUPERIORITY_OR_OTHER|||||||0.592||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.592
71661567|NCT01193127|142836594|SUPERIORITY_OR_OTHER|||||||0.787||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.787
71661568|NCT01193127|142836595|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
71661569|NCT01193127|142836595|SUPERIORITY_OR_OTHER|||||||0.166||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.166
71661570|NCT01193127|142836595|SUPERIORITY_OR_OTHER|||||||0.987||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.987
71661571|NCT01193127|142836596|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.134
71661572|NCT01193127|142836596|SUPERIORITY_OR_OTHER|||||||0.71||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.710
71661573|NCT01193127|142836596|SUPERIORITY_OR_OTHER|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.310
71661574|NCT01193127|142836597|SUPERIORITY_OR_OTHER|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.086
71661575|NCT01193127|142836597|SUPERIORITY_OR_OTHER|||||||0.183||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.183
71661576|NCT01193127|142836597|SUPERIORITY_OR_OTHER|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.029
71661577|NCT01193127|142836598|SUPERIORITY_OR_OTHER|||||||0.206||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.206
71661578|NCT01193127|142836598|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.021
71661579|NCT01193127|142836598|SUPERIORITY_OR_OTHER|||||||0.026||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.026
71661580|NCT01193127|142836599|SUPERIORITY_OR_OTHER|||||||0.822||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.822
71661581|NCT01193127|142836599|SUPERIORITY_OR_OTHER|||||||0.424||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.424
71661582|NCT01193127|142836599|SUPERIORITY_OR_OTHER|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.695
71740231|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0040
71661583|NCT01193127|142836600|SUPERIORITY_OR_OTHER|||||||0.489||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.489
71661584|NCT01193127|142836600|SUPERIORITY_OR_OTHER|||||||0.459||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.459
71661585|NCT01193127|142836600|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count \> 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test|||||||0.990
71661586|NCT01193127|142836602|SUPERIORITY_OR_OTHER|||||||0.4575||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.4575
71661587|NCT01193127|142836602|SUPERIORITY_OR_OTHER|||||||0.8318||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8318
71661588|NCT01193127|142836602|SUPERIORITY_OR_OTHER|||||||0.8946||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.8946
71661589|NCT01193127|142836603|SUPERIORITY_OR_OTHER|||||||0.157||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.1570
71661590|NCT01193127|142836603|SUPERIORITY_OR_OTHER|||||||0.0839||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0839
71661591|NCT01193127|142836603|SUPERIORITY_OR_OTHER|||||||0.092||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel|||||||0.0920
71661592|NCT01193127|142836604|SUPERIORITY_OR_OTHER|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.711
71661593|NCT01193127|142836604|SUPERIORITY_OR_OTHER|||||||0.253||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.253
71661594|NCT01193127|142836604|SUPERIORITY_OR_OTHER|||||||0.104||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel|||||||0.104
71661595|NCT03246646|142836607|SUPERIORITY||Z test of proportions|0.66|||>|0.05|ONE_SIDED||||||Z test of independent proportions|||||||>.05
71661596|NCT02569112|142836608|SUPERIORITY|A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Used Wilcoxon Matched-Pairs Signed-Ranks test||The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.||||<0.01
71661597|NCT02352779|142836609|OTHER||Mean Difference (Final Values)|0.6763|STANDARD_ERROR_OF_MEAN|0.4843||0.1666|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1666
71661598|NCT02352779|142836609|OTHER||Mean Difference (Final Values)|0.6936|STANDARD_ERROR_OF_MEAN|0.4567||0.1329|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF||||0.1329
71661599|NCT02352779|142836609|OTHER||Mean Difference (Final Values)|0.0831|STANDARD_ERROR_OF_MEAN|3.8065||0.9826|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.9826
71661600|NCT02352779|142836609|OTHER||Mean Difference (Final Values)|2.9898|STANDARD_ERROR_OF_MEAN|3.5448||0.4016|TWO_SIDED||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF||||0.4016
71661601|NCT01398943|142836615|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71661602|NCT01398943|142836615|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71661603|NCT01398943|142836616|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71661604|NCT01398943|142836616|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71661605|NCT01565850|142836617|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 150 HIV-1 infected participants, randomized in a 2:1 ratio to 2 groups, would achieve 56% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 0.88 for both arms, a noninferiority margin of 0.12, and the significance level of the test at a one-sided 0.025 level were assumed.|Difference in proportions|3.3||||0.64|TWO_SIDED|95.0|-11.4|18.1||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 24; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.||18.1|-11.4|0.64
71661606|NCT01565850|142836618|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|Difference in proportions|-6.2||||0.35|TWO_SIDED|95.0|-19.9|7.4||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|||7.4|-19.9|0.35
71890637|NCT00619957|143302894|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Controlled for pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||||<0.0001
71890638|NCT00619957|143302895|SUPERIORITY_OR_OTHER||Relative Risk|0.771||||0.7284||95.0|0.184|3.226|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||3.226|0.184|0.7284
71890639|NCT00619957|143302896|SUPERIORITY_OR_OTHER||Relative Risk|0.688||||0.5293|TWO_SIDED|95.0|0.245|1.932|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.||1.932|0.245|0.5293
71890640|NCT00868790|143302903|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|-17.2||||0.013|TWO_SIDED|90.0|-28.3|-6.1|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-6.1|-28.3|0.013
71890641|NCT00868790|143302903|SUPERIORITY_OR_OTHER||LSM Difference|-23.4|||<|0.001|TWO_SIDED|90.0|-34.5|-12.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-12.4|-34.5|<0.001
71890642|NCT00868790|143302903|SUPERIORITY_OR_OTHER||LSM Difference|-34.9|||<|0.001|TWO_SIDED|95.0|-44.8|-25.0|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-25.0|-44.8|<0.001
71890643|NCT00868790|143302904|SUPERIORITY_OR_OTHER||LSM Difference|-11.5||||0.002|TWO_SIDED|90.0|-17.5|-5.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-5.4|-17.5|0.002
71890644|NCT00868790|143302904|SUPERIORITY_OR_OTHER||LSM Difference|-21.8|||<|0.001|TWO_SIDED|90.0|-27.8|-15.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-15.8|-27.8|<0.001
71890645|NCT00868790|143302904|SUPERIORITY_OR_OTHER||LSM Difference|-36.0|||<|0.001|TWO_SIDED|90.0|-42.0|-30.0|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-30.0|-42.0|<0.001
71890646|NCT00868790|143302904|SUPERIORITY_OR_OTHER||LSM Difference|-20.0||||0.001|TWO_SIDED|90.0|-30.0|-10.1|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-10.1|-30.0|0.001
71661607|NCT01565850|142836619|SUPERIORITY_OR_OTHER||Difference in LSM|0.04||||0.67|TWO_SIDED|95.0|-0.14|0.21||The p-value, difference in least squares mean (LSM), and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.21|-0.14|0.67
71661608|NCT01565850|142836620|SUPERIORITY_OR_OTHER||Difference in LSM|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||0.23|-0.11|0.50
71661609|NCT01565850|142836621|SUPERIORITY_OR_OTHER||Difference in LSM|45.0||||0.11|TWO_SIDED|95.0|-10.0|101.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||101|-10|0.11
71661610|NCT01565850|142836622|SUPERIORITY_OR_OTHER||Difference in LSM|18.0||||0.5|TWO_SIDED|95.0|-35.0|72.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or \> 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA|||||72|-35|0.50
71890647|NCT00868790|143302905|SUPERIORITY_OR_OTHER||LSM Difference|-14.9||||0.174|TWO_SIDED|90.0|-33.0|3.2|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||3.2|-33.0|0.174
71890648|NCT00868790|143302905|SUPERIORITY_OR_OTHER||LSM Difference|-20.4||||0.063|TWO_SIDED|90.0|-38.4|-2.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-2.4|-38.4|0.063
71775489|NCT01675427|143051131|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0001
71775490|NCT01675427|143051131|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.4820
71775491|NCT01675427|143051131|SUPERIORITY_OR_OTHER|||||||0.8668|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.8668
71775492|NCT01675427|143051131|SUPERIORITY_OR_OTHER|||||||0.2032|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.2032
71775493|NCT01675427|143051131|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775494|NCT01675427|143051132|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0103
71775495|NCT01675427|143051132|SUPERIORITY_OR_OTHER|||||||0.8373|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.8373
71775496|NCT01675427|143051132|SUPERIORITY_OR_OTHER|||||||0.3672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.3672
71775497|NCT01675427|143051133|SUPERIORITY_OR_OTHER|||||||0.0637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.0637
71775498|NCT01675427|143051133|SUPERIORITY_OR_OTHER|||||||0.0474|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.0474
71775499|NCT01675427|143051133|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775500|NCT01675427|143051134|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71775501|NCT01675427|143051134|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
71775502|NCT01675427|143051134|SUPERIORITY_OR_OTHER|||||||0.5522|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5522
71775503|NCT01675427|143051135|SUPERIORITY_OR_OTHER|||||||0.5117|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.5117
71775504|NCT01675427|143051135|SUPERIORITY_OR_OTHER|||||||0.3437|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3437
71775505|NCT01675427|143051135|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775506|NCT01675427|143051136|SUPERIORITY_OR_OTHER|||||||0.0381|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||0.0381
71775507|NCT01675427|143051136|SUPERIORITY_OR_OTHER|||||||0.6852|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.6852
71775508|NCT01675427|143051136|SUPERIORITY_OR_OTHER|||||||0.1185|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.1185
71775509|NCT01675427|143051137|SUPERIORITY_OR_OTHER|||||||0.2611|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.2611
71775510|NCT01675427|143051137|SUPERIORITY_OR_OTHER|||||||0.6059|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.6059
71775511|NCT01675427|143051137|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0001
71775512|NCT01675427|143051138|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71775513|NCT01675427|143051138|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2||||0.0048
71775514|NCT01675427|143051138|SUPERIORITY_OR_OTHER|||||||0.5127|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3||||0.5127
71775515|NCT01675427|143051139|SUPERIORITY_OR_OTHER|||||||0.3465|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4||||0.3465
71661611|NCT03611543|142836623|SUPERIORITY||||||<|0.0001||||||Information related to the INVESTIGATIONAL group.|Wilcoxon Rank-Sum test|||||||<0.0001
71661612|NCT00792935|142836706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|4.4||0.847|TWO_SIDED|95.0|-7.9|9.6|||Constrained longitudinal analysis|||Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.||9.6|-7.9|0.847
71661613|NCT00792935|142836707|SUPERIORITY_OR_OTHER||Proportions|-7.7||||0.361|TWO_SIDED|95.0|-23.6|8.7|||Miettinen & Nurminen method.||The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.|||8.7|-23.6|0.361
71661614|NCT04663295|142836708|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.3|7.9||One-sided test at significant level of 0.025.|Wilcoxon (Mann-Whitney)|Wilcoxon Signed rank test comparing baseline and study period.||||7.9|3.3|<0.001
71661615|NCT03954834|142836718|SUPERIORITY||LS Mean Difference|-1.91|||<|0.001|TWO_SIDED|95.0|-2.18|-1.63|||Mixed Models Analysis|||||-1.63|-2.18|<0.001
71661616|NCT03954834|142836718|SUPERIORITY||LS Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.21|-1.65|||Mixed Models Analysis|||||-1.65|-2.21|<0.001
71661617|NCT03954834|142836718|SUPERIORITY||LS Mean Difference|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||Mixed Models Analysis|||||-1.83|-2.39|<0.001
71661618|NCT03954834|142836719|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-7.8|-4.7|||Mixed Models Analysis|||||-4.7|-7.8|<0.001
71661619|NCT03954834|142836719|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.6|-5.5|||Mixed Models Analysis|||||-5.5|-8.6|<0.001
71661620|NCT03954834|142836719|SUPERIORITY||LS Mean Difference|-8.8|||<|0.001|TWO_SIDED|95.0|-10.3|-7.2|||Mixed Models Analysis|||||-7.2|-10.3|<0.001
71661621|NCT03954834|142836720|SUPERIORITY||Odds Ratio (OR)|49.0|||<|0.001|TWO_SIDED|95.0|21.12|113.67|||Regression, Logistic|||||113.67|21.12|<0.001
71661622|NCT03954834|142836720|SUPERIORITY||Odds Ratio (OR)|80.39|||<|0.001|TWO_SIDED|95.0|31.8|203.19|||Regression, Logistic|||||203.19|31.80|<0.001
71661623|NCT03954834|142836720|SUPERIORITY||Odds Ratio (OR)|52.95|||<|0.001|TWO_SIDED|95.0|22.3|125.73|||Regression, Logistic|||||125.73|22.30|<0.001
71661624|NCT03954834|142836721|SUPERIORITY||LS Mean Difference|-1.5||||0.776|TWO_SIDED|95.0|-11.9|8.9|||Mixed Models Analysis|||||8.9|-11.9|0.776
71661625|NCT03954834|142836721|SUPERIORITY||LS Mean Difference|-2.6||||0.622|TWO_SIDED|95.0|-13.0|7.8|||Mixed Models Analysis|||||7.8|-13.0|0.622
71661626|NCT03954834|142836721|SUPERIORITY||LS Mean Difference|-0.6||||0.908|TWO_SIDED|95.0|-11.1|9.8|||Mixed Models Analysis|||||9.8|-11.1|0.908
71661627|NCT03954834|142836722|SUPERIORITY||Odds Ratio (OR)|40.28|||<|0.001|TWO_SIDED|95.0|7.74|209.71|||Regression, Logistic|||||209.71|7.74|<0.001
71661628|NCT03954834|142836722|SUPERIORITY||Odds Ratio (OR)|34.12|||<|0.001|TWO_SIDED|95.0|6.53|178.19|||Regression, Logistic|||||178.19|6.53|<0.001
71661629|NCT03954834|142836722|SUPERIORITY||Odds Ratio (OR)|85.13|||<|0.001|TWO_SIDED|95.0|16.36|443.13|||Regression, Logistic|||||443.13|16.36|<0.001
71661630|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.1|-31.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-31.2|-44.1|<0.001
71661631|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-38.6|||<|0.001|TWO_SIDED|95.0|-45.1|-32.2|||Mixed Models Analysis|||Morning Premeal - Fasting||-32.2|-45.1|<0.001
71661632|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-36.5|||<|0.001|TWO_SIDED|95.0|-43.1|-29.8|||Mixed Models Analysis|||Morning Premeal - Fasting||-29.8|-43.1|<0.001
71775516|NCT01675427|143051139|SUPERIORITY_OR_OTHER|||||||0.7358|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7358
71661633|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-57.9|||<|0.001|TWO_SIDED|95.0|-68.4|-47.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-47.4|-68.4|<0.001
71661634|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-49.7|||<|0.001|TWO_SIDED|95.0|-60.3|-39.2|||Mixed Models Analysis|||Morning 2-hour Postmeal||-39.2|-60.3|<0.001
71661635|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-57.3|||<|0.001|TWO_SIDED|95.0|-68.1|-46.4|||Mixed Models Analysis|||Morning 2-hour Postmeal||-46.4|-68.1|<0.001
71661636|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-40.9|||<|0.001|TWO_SIDED|95.0|-49.6|-32.2|||Mixed Models Analysis|||Midday Premeal||-32.2|-49.6|<0.001
71661637|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-39.9|||<|0.001|TWO_SIDED|95.0|-48.6|-31.2|||Mixed Models Analysis|||Midday Premeal||-31.2|-48.6|<0.001
71661638|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-40.0|||<|0.001|TWO_SIDED|95.0|-49.0|-31.1|||Mixed Models Analysis|||Midday Premeal||-31.1|-49.0|<0.001
71661639|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-51.4|||<|0.001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||Midday 2-hour Postmeal||-40.4|-62.5|<0.001
71661640|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-47.3|||<|0.001|TWO_SIDED|95.0|-58.4|-36.2|||Mixed Models Analysis|||Midday 2-hour Postmeal||-36.2|-58.4|<0.001
71661641|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-62.1|-39.3|||Mixed Models Analysis|||Midday 2-hour Postmeal||-39.3|-62.1|<0.001
71661642|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-39.0|||<|0.001|TWO_SIDED|95.0|-47.6|-30.4|||Mixed Models Analysis|||Evening Premeal||-30.4|-47.6|<0.001
71661643|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-39.2|||<|0.001|TWO_SIDED|95.0|-47.9|-30.6|||Mixed Models Analysis|||Evening Premeal||-30.6|-47.9|<0.001
71661644|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-36.4|||<|0.001|TWO_SIDED|95.0|-45.3|-27.5|||Mixed Models Analysis|||Evening Premeal||-27.5|-45.3|<0.001
71661645|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-63.2|-40.1|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.1|-63.2|<0.001
71661646|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-52.5|||<|0.001|TWO_SIDED|95.0|-64.1|-40.9|||Mixed Models Analysis|||Evening 2-hour Postmeal||-40.9|-64.1|<0.001
71661647|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-53.2|||<|0.001|TWO_SIDED|95.0|-65.1|-41.3|||Mixed Models Analysis|||Evening 2-hour Postmeal||-41.3|-65.1|<0.001
71661648|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-48.0|||<|0.001|TWO_SIDED|95.0|-58.6|-37.4|||Mixed Models Analysis|||Bedtime||-37.4|-58.6|<0.001
71661649|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-50.7|||<|0.001|TWO_SIDED|95.0|-61.3|-40.1|||Mixed Models Analysis|||Bedtime||-40.1|-61.3|<0.001
71661650|NCT03954834|142836723|SUPERIORITY||LS Mean Difference|-51.7|||<|0.001|TWO_SIDED|95.0|-62.6|-40.9|||Mixed Models Analysis|||||-40.9|-62.6|<0.001
71661651|NCT03954834|142836724|SUPERIORITY||Odds Ratio (OR)|12.4|||<|0.001|TWO_SIDED|95.0|6.43|23.94|||Regression, Logistic|||||23.94|6.43|<0.001
71661652|NCT03954834|142836724|SUPERIORITY||Odds Ratio (OR)|21.13|||<|0.001|TWO_SIDED|95.0|10.59|42.18|||Regression, Logistic|||||42.18|10.59|<0.001
71661653|NCT03954834|142836724|SUPERIORITY||Odds Ratio (OR)|20.1|||<|0.001|TWO_SIDED|95.0|10.09|40.04|||Regression, Logistic|||||40.04|10.09|<0.001
71661654|NCT01404923|142836749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
71661655|NCT01781481|142836751|SUPERIORITY_OR_OTHER||Inter-rater reliability|0.87|||||TWO_SIDED||||||||Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.|||||
71661656|NCT01781481|142836751|SUPERIORITY_OR_OTHER||Cronbach's Alpha|0.91|||||TWO_SIDED||||||||Overall internal consistency of the overall Pediatric INTERMED scale (34 items).|||||
71661657|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.05||||||Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p\< .05.|Pearson Correlation Coefficients|||||||<0.05
71661658|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Social domain scores on the Pediatric INTERMED.||||<0.01
71661659|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
71661660|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Biological and Health Service Pediatric INTERMED domain scores.||||<0.01
71661661|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Psychology and Social Pediatric INTERMED domain scores.||||<0.01
71661662|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||||||<0.01
71775517|NCT01675427|143051139|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71661663|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.||||<0.01
71661664|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.||||<0.01
71661665|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Social and Health Service Pediatric INTERMED domain scores.||||<0.01
71775518|NCT01675427|143051140|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71775519|NCT01675427|143051141|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71661666|NCT01781481|142836752|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.||||<0.01
71661667|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis||||>0.05
71661668|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).||||<0.01
71661669|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).||||<0.01
71661670|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).||||<0.01
71661671|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.||||<0.01
71661672|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.||||>0.05
71661673|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.||||>0.05
71661674|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.||||>0.05
71661675|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.||||>0.05
71661676|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.||||>0.05
71661677|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).||||>0.05
71661678|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)||||>0.05
71661679|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)||||<0.01
71661680|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.||||>0.05
71661681|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.||||>0.05
71661682|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.||||>0.05
71661683|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\< 0.05.|Spearman Correlation Coefficent|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)||||<0.05
71661684|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.||||>0.05
71661685|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis."||||>0.05
71661686|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.01
71661687|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating)."||||<0.01
71661688|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||<0.01
71661689|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scale"||||<0.01
71740232|NCT00445770|142992935|SUPERIORITY_OR_OTHER|||||||0.2326|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.2326
71896343|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|4.655||||0.009|TWO_SIDED|95.0|1.478|14.666||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||14.666|1.478|0.009
71661690|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeries"||||>0.05
71661691|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone."||||>0.05
71661692|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators."||||>0.05
71661693|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications."||||>0.05
71661694|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05. The P-Value indicated above was found for all the correlations which were examined.|Spearman Correlation Coefficient|||"Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications."||||>0.05
71661695|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis."||||>0.05
71661696|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation."||||<0.05
71661697|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)"||||<0.05
71661698|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating)."||||>0.05
71661699|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale"||||<0.01
71740233|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
71740234|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
71661700|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries."||||>0.05
71661701|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone."||||>0.05
71661702|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. ."||||>0.05
71661703|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medications"||||>0.05
71661704|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis."||||>0.05
71740235|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.4751|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4751
71740236|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71740237|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71740238|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.4653|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.4653
71740239|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71740240|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71740241|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.7953|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7953
71740242|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
71740243|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
71740244|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.0848|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0848
71661705|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview)."||||>0.05
71740245|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
71661706|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating)."||||>0.05
71661707|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)"||||>0.05
71740246|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
71740247|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.6112|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.6112
71740248|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
71740249|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0002
71740250|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.3671
71740251|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71740252|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71740253|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.7618|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7618
71740254|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71740255|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71740256|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.4358|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4358
71740257|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0008
71740258|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71740259|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.6267|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.6267
71740260|NCT00445770|142992936|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
71740261|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0004
71740262|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.3564|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.3564
71740263|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0007
71740264|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.0035
71740265|NCT00445770|142992936|SUPERIORITY_OR_OTHER|||||||0.4749|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.4749
71740266|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||<0.0001
71740267|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0001
71740268|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.4376|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.4376
71740269|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71740270|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||<0.0001
71740271|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.3947|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.3947
71740272|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71740273|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71740274|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.7378|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.7378
71740275|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0001
71740276|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||<0.0001
71740277|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.568|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.5680
71740278|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0003
71740279|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||<0.0001
71740280|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.3978|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.3978
71740281|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||<0.0001
71740282|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0001
71740283|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.7229|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.7229
71740284|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71740285|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||<0.0001
71740286|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.7236|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.7236
71740287|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71740288|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71740289|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.9719|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.9719
71740290|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71740291|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71740292|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.9349|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.9349
71740293|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
71740294|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0002
71740295|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.7226|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.7226
71740296|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71740297|NCT00445770|142992937|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71740298|NCT00445770|142992937|SUPERIORITY_OR_OTHER|||||||0.5512|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.5512
71740299|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0162
71740300|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.0035
71740301|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.8928|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2||||0.8928
71890649|NCT00868790|143302905|SUPERIORITY_OR_OTHER||LSM Difference|-78.1|||<|0.001|TWO_SIDED|90.0|-96.4|-59.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-59.8|-96.4|<0.001
71890650|NCT00868790|143302905|SUPERIORITY_OR_OTHER||LSM Difference|-49.4|||<|0.001|TWO_SIDED|90.0|-66.9|-31.8|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). The LDA-model test was conducted at alpha level=0.10 (two sided).||-31.8|-66.9|<0.001
71890651|NCT00868790|143302906|SUPERIORITY_OR_OTHER||LSM Difference|-0.8||||0.742|TWO_SIDED|90.0|-4.6|3.1|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||3.1|-4.6|0.742
71890652|NCT00868790|143302906|SUPERIORITY_OR_OTHER||LSM Difference|4.5||||0.06|TWO_SIDED|90.0|0.6|8.4|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||8.4|0.6|0.060
71890653|NCT00868790|143302906|SUPERIORITY_OR_OTHER||LSM Difference|7.8||||0.002|TWO_SIDED|90.0|3.8|11.7|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||11.7|3.8|0.002
71890654|NCT00868790|143302906|SUPERIORITY_OR_OTHER||LSM Difference|-3.9||||0.248|TWO_SIDED|90.0|-10.2|2.3|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits \[yes/no\]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).||2.3|-10.2|0.248
71890655|NCT03377634|143302915|OTHER|Analysis of covariance on change in PROMIS Pain intensity, with group as fixed effect and controlling for baseline pain intensity||||||0.11|||||||ANCOVA|||||||0.11
71890656|NCT03377634|143302916|OTHER|Analysis of covariance on change in PROMIS pain interference, with group as fixed effect and controlling for baseline pain interference||||||0.99|||||||ANCOVA|||||||.99
71661708|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Being"||||>0.05
71890657|NCT03377634|143302917|OTHER|Analysis of covariance on change in SPPB, with group as fixed effect and controlling for baseline SPPB||||||0.14|||||||ANCOVA|||||||.14
71890658|NCT03377634|143302918|OTHER|Analysis of covariance on change in weight, with group as fixed effect and controlling for baseline weight||||||0.11|||||||ANCOVA|||||||.11
71661709|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries."||||>0.05
71661710|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis."||||<0.05
71661711|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significiance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.01
71661712|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The Threshold for significance is p\<0.05)|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab)."||||<0.01
71890659|NCT03377634|143302919|OTHER|Analysis of covariance on change in activity time, with group as fixed effect and controlling for baseline stepping time||||||0.65|||||||ANCOVA|||||||.65
71890660|NCT03377634|143302920|OTHER|Analysis of covariance on change in sitting time, with group as fixed effect and controlling for baseline sitting time||||||0.41|||||||ANCOVA|||||||.41
71661713|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis."||||>0.05
71661714|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation."||||<0.05
71661715|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating)."||||<0.01
71661716|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating)."||||<0.01
71661717|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale."||||<0.05
71661718|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries."||||>0.05
71661719|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone."||||>0.05
71775520|NCT01675427|143051142|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||< 0.0001
71661720|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate)."||||<0.05
71775521|NCT01675427|143051143|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED|||||Pearson Chi-Square Tests for association between the two variables|Chi-squared|||||||0.0066
71775522|NCT01675427|143051144|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0018
71775523|NCT01675427|143051144|SUPERIORITY_OR_OTHER|||||||0.0425|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0425
71775524|NCT01675427|143051144|SUPERIORITY_OR_OTHER|||||||0.9829|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9829
71775525|NCT01675427|143051144|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6700
71890661|NCT03377634|143302921|OTHER|Analysis of covariance on change in sit to stand transitions, with group as fixed effect and controlling for baseline transitions||||||0.28|||||||ANCOVA|||||||.28
71661721|NCT01781481|142836766|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications."||||>0.05
71661722|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
71661723|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
71661724|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score||||<0.01
71775526|NCT01675427|143051144|SUPERIORITY_OR_OTHER|||||||0.7672|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7672
71775527|NCT01675427|143051144|SUPERIORITY_OR_OTHER|||||||0.0067|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0067
71775528|NCT01675427|143051145|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0003
71775529|NCT01675427|143051145|SUPERIORITY_OR_OTHER|||||||0.1637|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1637
71775530|NCT01675427|143051145|SUPERIORITY_OR_OTHER|||||||0.8579|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.8579
71775531|NCT01675427|143051145|SUPERIORITY_OR_OTHER|||||||0.6935|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.6935
71775532|NCT01675427|143051145|SUPERIORITY_OR_OTHER|||||||0.8124|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8124
71775533|NCT01675427|143051145|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775534|NCT01675427|143051146|SUPERIORITY_OR_OTHER|||||||0.1834|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1834
71775535|NCT01675427|143051146|SUPERIORITY_OR_OTHER|||||||0.8543|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.8543
71775536|NCT01675427|143051146|SUPERIORITY_OR_OTHER|||||||0.1485|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.1485
71775537|NCT01675427|143051146|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0260
71775538|NCT01675427|143051146|SUPERIORITY_OR_OTHER|||||||0.5317|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5317
71775539|NCT01675427|143051146|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0005
71775540|NCT01675427|143051147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71740302|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0009
71740303|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.0007
71740304|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.6348|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4||||0.6348
71740305|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.0026
71740306|NCT00445770|142992938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||<0.0001
71740307|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.4629|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8||||0.4629
71740308|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0841
71740309|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.0007
71740310|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.1957|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12||||0.1957
71740311|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0093
71740312|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0326|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.0326
71740313|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.7426|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16||||0.7426
71740314|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0013
71740315|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.0015
71740316|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.6552|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20||||0.6552
71775541|NCT01675427|143051147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
71740317|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0005
71775542|NCT01675427|143051147|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.4423
71775543|NCT01675427|143051147|SUPERIORITY_OR_OTHER|||||||0.3824|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.3824
71775544|NCT01675427|143051147|SUPERIORITY_OR_OTHER|||||||0.5246|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.5246
71775545|NCT01675427|143051147|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71740318|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.0004
71740319|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.6294|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24||||0.6294
71740320|NCT00445770|142992938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||<0.0001
71740321|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.0001
71740322|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.4652|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32||||0.4652
71740323|NCT00445770|142992938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||<0.0001
71740324|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.0002
71740325|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.2233|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40||||0.2233
71740326|NCT00445770|142992938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||<0.0001
71740327|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.0003
71740328|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.6772|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48||||0.6772
71740329|NCT00445770|142992938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71740330|NCT00445770|142992938|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||<0.0001
71740331|NCT00445770|142992938|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52||||0.6160
71740332|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71740333|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||<0.0001
71775546|NCT01675427|143051148|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||< 0.0001
71890662|NCT01818297|143302947|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|10.5||0.14|ONE_SIDED|95.0|-5.8|||Due to early termination, the study was insufficiently powered to test the primary objective. This analysis is exploratory and descriptive in nature and cannot be considered conclusive.|Z-test|The Z-test (using an unpooled standard deviation, without continuity correction) was used to test the difference in responder rates between groups.|The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group.|The original sample size estimate for the primary objective was based on the following assumptions: 109 subjects in each arm with a responder rate of 22% in the Control group and 40% in the Treatment group, and a one-sided α= 0.05 using a Z test with unpooled variance, would result in 90% power. Because the study terminated early, the actual sample size (32 in Treatment, 30 in Control) resulted in 47% power under the same assumptions.|||-5.8|0.14
71890663|NCT01651780|143302953|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.77||||0.2692|TWO_SIDED|95.0|0.48|1.23|||Chi-squared|||||1.23|0.48|0.2692
71890664|NCT01651780|143302954|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.89||||0.4967|TWO_SIDED|95.0|0.64|1.24|||Chi-squared|||||1.24|0.64|0.4967
71890665|NCT02930174|143302967|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.26|TWO_SIDED||||||ANOVA|||||||0.26
71890666|NCT02930174|143302968|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.342|TWO_SIDED||||||ANOVA|||||||0.342
71890667|NCT02930174|143302969|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.184|TWO_SIDED||||||ANOVA|||||||0.184
71890668|NCT02930174|143302970|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.283|TWO_SIDED||||||ANOVA|||||||0.283
71890669|NCT02930174|143302971|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.204|TWO_SIDED||||||ANOVA|||||||0.204
71740334|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.4929|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2||||0.4929
71890670|NCT02930174|143302972|EQUIVALENCE|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|2.0||0.136|TWO_SIDED||||||ANOVA|||||||0.136
71775547|NCT01675427|143051148|SUPERIORITY_OR_OTHER|||||||0.1947|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.1947
71740335|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71740336|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71740337|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.9693|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.9693
71740338|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71740339|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71740340|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.4139|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.4139
71740341|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71740342|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71740343|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.8905|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.8905
71740344|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71775548|NCT01675427|143051148|SUPERIORITY_OR_OTHER|||||||0.0226|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.0226
71775549|NCT01675427|143051149|SUPERIORITY_OR_OTHER|||||||0.1158|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.1158
71775550|NCT01675427|143051149|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.3675
71775551|NCT01675427|143051149|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0948
71890671|NCT02901431|143302973|SUPERIORITY||Difference in Adjusted LSMeans|-0.16||||0.911|TWO_SIDED|90.0|-2.56|2.23|||Mixed Models Analysis|||||2.23|-2.56|0.911
71740345|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71740346|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.6877|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.6877
71740347|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71740348|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71740349|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.4511|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.4511
71740350|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71740351|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71740352|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.2786
71740353|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71740354|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71740355|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.1230
71740356|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71740357|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71740358|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.5061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.5061
71740359|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71740360|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71740361|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.1354|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.1354
71740362|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71775552|NCT01675427|143051150|SUPERIORITY_OR_OTHER|||||||0.1236|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.1236
71775553|NCT01675427|143051150|SUPERIORITY_OR_OTHER|||||||0.0119|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.0119
71775554|NCT01675427|143051150|SUPERIORITY_OR_OTHER|||||||0.7472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.7472
71775555|NCT01675427|143051151|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.9734
71775556|NCT01675427|143051151|SUPERIORITY_OR_OTHER|||||||0.8303|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.8303
71775557|NCT01675427|143051151|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0006
71740363|NCT00445770|142992939|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71740364|NCT00445770|142992939|SUPERIORITY_OR_OTHER|||||||0.1734|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1734
71740365|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740366|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||<0.0001
71740367|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.6417|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2||||0.6417
71740368|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740369|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||<0.0001
71740370|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.4698|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4||||0.4698
71890672|NCT02901431|143302974|SUPERIORITY||Difference in adjused LSMean|0.29|||||TWO_SIDED|90.0|-1.85|2.43||||||Week 12||2.43|-1.85|
71890673|NCT02901431|143302974|SUPERIORITY||Difference in adjusted LSMean|-0.23|||||TWO_SIDED|90.0|-2.67|2.22||||||Week 24||2.22|-2.67|
71890674|NCT02901431|143302975|SUPERIORITY||Difference in adjusted LSMean|-0.22|||||TWO_SIDED|90.0|-2.36|1.92||||||Communication Domain Standard Score, Week 12||1.92|-2.36|
71890675|NCT02901431|143302975|SUPERIORITY||Difference in adjusted LSMean|0.71|||||TWO_SIDED|90.0|-1.6|3.02||||||Communication Domain Standard Score, Week 24||3.02|-1.60|
71890676|NCT02901431|143302975|SUPERIORITY||Difference in adjusted LSMean|0.51|||||TWO_SIDED|90.0|-2.1|3.12||||||Socialization Domain Standard Score, Week 12||3.12|-2.10|
71890677|NCT02901431|143302975|SUPERIORITY|Socialization Domain Standard Score, Week 24|Difference in adjusted LSMean|-0.61|||||TWO_SIDED|90.0|-3.74|2.51||||||||2.51|-3.74|
71890678|NCT02901431|143302975|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 12|Difference in adjusted LSMean|2.14|||||TWO_SIDED|90.0|-0.63|4.9||||||||4.90|-0.63|
71661725|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
71775558|NCT01675427|143051152|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0065
71775559|NCT01675427|143051152|SUPERIORITY_OR_OTHER|||||||0.9999|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||0.9999
71775560|NCT01675427|143051152|SUPERIORITY_OR_OTHER|||||||0.3472|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.3472
71775561|NCT01675427|143051153|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.2564
71890679|NCT02901431|143302975|SUPERIORITY|Daily Living Skills Domain Standard Score, Week 24|Differences in adjusted LSMean|0.18|||||TWO_SIDED|90.0|-2.87|3.22||||||||3.22|-2.87|
71890680|NCT02901431|143302981|SUPERIORITY||Difference of Adjusted LS Means|3.74|||||TWO_SIDED|90.0|0.78|6.7|||Mixed Models Analysis|||Week 12||6.70|0.78|
71775562|NCT01675427|143051153|SUPERIORITY_OR_OTHER|||||||0.7361|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.7361
71890681|NCT02901431|143302981|SUPERIORITY||Difference of Adjusted LS means|2.28|||||TWO_SIDED|90.0|-0.73|5.29||||||Week 24||5.29|-0.73|
71775563|NCT01675427|143051153|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||< 0.0001
71775564|NCT01675427|143051154|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1||||0.0097
71775565|NCT01675427|143051154|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2||||< 0.0001
71890682|NCT02901431|143302983|SUPERIORITY||Difference in Adjusted LS Means|0.01||||0.992|TWO_SIDED|90.0|-1.99|2.01|||Mixed Models Analysis|||||2.01|-1.99|0.992
71890683|NCT01272583|143302985|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||1.0
71890684|NCT01272583|143302986|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||GLP-1 intact|ANOVA|The Friedman Test was used for ANOVA||||||<0.001
71890685|NCT01272583|143302986|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||GLP-1 Total|ANOVA|The Friedman Test was used for ANOVA.||||||0.98
71661726|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
71775566|NCT01675427|143051154|SUPERIORITY_OR_OTHER|||||||0.9778|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3||||0.9778
71775567|NCT01675427|143051155|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4||||0.0151
71775568|NCT01675427|143051155|SUPERIORITY_OR_OTHER|||||||0.1052|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes||||0.1052
71890686|NCT01272583|143302986|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||GIP intact|ANOVA|The Friedman Test was used for ANOVA.||||||0.049
71890687|NCT01272583|143302986|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||GIP total|ANOVA|The Friedman Test was used for ANOVA||||||0.44
71890688|NCT01272583|143302987|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.14
71890689|NCT01272583|143302988|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.98
71890690|NCT01272583|143302989|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.22
71890691|NCT01272583|143302990|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.01
71890692|NCT01272583|143302990|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Dunn's Multiple Comparison Test|Post Hoc testing||||||<0.05
71890693|NCT01272583|143302991|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|The Friedman Test was used for ANOVA.||||||0.76
71890694|NCT04672083|143303025|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
71890695|NCT04672083|143303026|OTHER||||||<|0.05|||||||ANOVA|||"CPT31 dose proportionality will be examined across dose groups using a power model approach or ANOVA model, as appropriate.PK parameters will be analyzed using a power model that will have the following form: parameter = intercept × dose\^slope + random error.~Using the natural log (ln) transformation, a power model can be expressed as a linear regression equation: ln(parameter) = intercept + slope × ln(dose) + random error. For dose proportionality, the slope = 1; for dose independence, = 0."||||<0.05
71740371|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740372|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||<0.0001
71740373|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.1214|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8||||0.1214
71740374|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740375|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||<0.0001
71740376|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.4654|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12||||0.4654
71740377|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740378|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||<0.0001
71740379|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.4006|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16||||0.4006
71740380|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740381|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||<0.0001
71740382|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.1636|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20||||0.1636
71740383|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740384|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||<0.0001
71740385|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.2635|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24||||0.2635
71740386|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71740387|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||<0.0001
71775569|NCT01675427|143051155|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes||||0.0007
71775570|NCT01675427|143051156|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71740388|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32||||0.0965
71740389|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740390|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||<0.0001
71740391|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.4437|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40||||0.4437
71740392|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740393|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||<0.0001
71740394|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.1663|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48||||0.1663
71740395|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740396|NCT00445770|142992940|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||<0.0001
71740397|NCT00445770|142992940|SUPERIORITY_OR_OTHER|||||||0.1049|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52||||0.1049
71740398|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
71740399|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||<0.0001
71740400|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2||||0.0442
71740401|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71740402|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||<0.0001
71661727|NCT01781481|142836767|SUPERIORITY_OR_OTHER|||||||0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).||||0.01
71661728|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.05
71661729|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
71661730|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale||||<0.01
71661731|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.05
71661732|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
71661733|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
71661734|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
71661735|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
71661736|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score||||<0.01
71661737|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.||||<0.05
71661738|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale||||<0.01
71661739|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
71661740|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
71661741|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
71661742|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale||||<0.01
71661743|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
71661744|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).||||<0.01
71661745|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
71661746|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).||||<0.01
71661747|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).||||<0.01
71661748|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score||||<0.01
71661749|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.||||>0.05
71661750|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale||||<0.01
71740403|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0681|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4||||0.0681
71740404|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71890696|NCT04672083|143303027|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% confidence interval for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71890697|NCT04672083|143303028|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71890698|NCT04672083|143303029|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71890699|NCT04672083|143303030|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71890700|NCT04672083|143303031|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71890701|NCT04672083|143303032|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantification.||||<0.05
71890702|NCT04672083|143303033|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
71890703|NCT04672083|143303034|OTHER||||||<|0.05|||||||Regression, Linear|||Concentrations for all subjects in Cohorts 1-3 were below the limit of quantitation||||<0.05
71740405|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||<0.0001
71890704|NCT04672083|143303035|OTHER||||||<|0.05|||||||Regression, Linear|||The lack of fit test will be conducted for the statistical assessment of linearity assumption (AOL), and thus appropriateness of a power model. PK parameter is dose proportional if AOL is ruled acceptable and the 95% CI for the slope spans 1. If the AOL is ruled unacceptable for any PK parameter, its corresponding PK parameter normalized by dose administered will be ln-transformed and analyzed using an analysis of variance (ANOVA) model. The model will include dose as a factor.||||<0.05
71890705|NCT01552343|143303061|SUPERIORITY_OR_OTHER|||||||0.0187||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Correlation - no adjustments||||0.0187
71661751|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).||||<0.01
71740406|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0966|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8||||0.0966
71740407|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||<0.0001
71890706|NCT01552343|143303061|SUPERIORITY_OR_OTHER|||||||0.0094||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline # of voids||||0.0094
71890707|NCT01552343|143303061|SUPERIORITY_OR_OTHER|||||||0.0383||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline NI total score||||0.0383
71890708|NCT01552343|143303061|SUPERIORITY_OR_OTHER|||||||0.0133||95.0||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - age category||||0.0133
71890709|NCT01552343|143303061|SUPERIORITY_OR_OTHER|||||||0.0128||95.0|||||t-test, 2 sided|The a priori threshold for statistical significance was 0.05.||Partial correlation - gender||||0.0128
71890710|NCT01552343|143303062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7|||||TWO_SIDED|95.0|2.7|18.8|||||Non-Responders - Responders|Nocturia Impact (NI) Total Score (Q1-Q11)||18.8|2.7|
71890711|NCT01552343|143303062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-9.6|9.6|||||Non-Responders - Responders|Overall Impact Question (Q12)||9.6|-9.6|
71775571|NCT01675427|143051156|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0012
71890712|NCT01552343|143303065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6||||0.1471|TWO_SIDED|95.0|-20.3|3.1||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Screening||3.1|-20.3|0.1471
71740408|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.0006
71740409|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.1242|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12||||0.1242
71740410|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.0001
71890713|NCT01552343|143303065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.0318|TWO_SIDED|95.0|-26.0|-1.2||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Baseline||-1.2|-26.0|0.0318
71890714|NCT01552343|143303065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.8||||0.0463|TWO_SIDED|95.0|-31.2|-0.3||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Screening||-0.3|-31.2|0.0463
71890715|NCT01552343|143303065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.7||||0.0413|TWO_SIDED|95.0|-34.6|-0.7||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Baseline||-0.7|-34.6|0.0413
71890716|NCT01552343|143303066|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-6.6|6.3|||ANCOVA|Covariates baseline score, treatment and age stratum (\<65, \>=65).||Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.||6.3|-6.6|0.9647
71890717|NCT00288574|143303109|SUPERIORITY|||||||0.57|||||||Chi-squared|||The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.||||0.57
71890718|NCT00288574|143303110|SUPERIORITY|||||||0.75||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.||||0.75
71890719|NCT00288574|143303111|SUPERIORITY|||||||0.007||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups||||0.007
71890720|NCT00288574|143303112|SUPERIORITY|||||||0.79||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.||||0.79
71890721|NCT00288574|143303113|SUPERIORITY|||||||0.69||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.||||0.69
71890722|NCT00288574|143303114|SUPERIORITY|||||||0.78||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.||||0.78
71890723|NCT00288574|143303115|SUPERIORITY|||||||0.19||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.||||0.19
71890724|NCT00288574|143303116|SUPERIORITY|||||||0.46||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.||||0.46
71890725|NCT00288574|143303117|SUPERIORITY|||||||0.86||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.||||0.86
71890726|NCT00288574|143303118|SUPERIORITY|||||||0.25||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.||||0.25
71890727|NCT00288574|143303119|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is \<0.005.||Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.||||0.26
71890728|NCT00046228|143303120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.551||95.0|0.67|1.23||The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.|Log Rank|Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death \& resuscitated v fib assessed by the investigator)||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.||1.23|0.67|0.551
71890729|NCT00046228|143303120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.858||95.0|0.72|1.31|||Log Rank|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%||1.31|0.72|0.858
71890730|NCT00046228|143303120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.676||95.0|0.69|1.27|||Log Rank|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.||1.27|0.69|0.676
71890731|NCT00046228|143303121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.247||95.0|0.57|1.16|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.16|0.57|0.247
71890732|NCT00046228|143303121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.278||95.0|0.58|1.17|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.||1.17|0.58|0.278
71890733|NCT00046228|143303121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.944||95.0|0.68|1.43|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.||1.43|0.68|0.944
71740411|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||<0.001
71740412|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16||||0.1521
71740413|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||<0.0001
71740414|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0070
71740415|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20||||0.0140
71740416|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71740417|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||<0.0001
71740418|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0815|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24||||0.0815
71740419|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||<0.0001
71740420|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0002
71740421|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0886|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32||||0.0886
71740422|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||<0.0001
71740423|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.0003
71740424|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.1488|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40||||0.1488
71740425|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||<0.0001
71740426|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0006
71740427|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0979|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48||||0.0979
71740428|NCT00445770|142992941|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||<0.0001
71740429|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.0001
71740430|NCT00445770|142992941|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52||||0.1740
71775572|NCT01675427|143051156|SUPERIORITY_OR_OTHER|||||||0.1717|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1717
71775573|NCT01675427|143051156|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0253
71740431|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.||Week 2||||<0.0001
71740432|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 2||||<0.0001
71740433|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED|||||p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.|ANCOVA|||Week 2||||0.0274
71740434|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
71740435|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||<0.0001
71740436|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0344|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4||||0.0344
71740437|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
71740438|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||<0.0001
71740439|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0293|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8||||0.0293
71740440|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
71740441|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||<0.0001
71740442|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0452|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12||||0.0452
71740443|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
71890734|NCT00046228|143303122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.494||95.0|0.74|1.84|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.84|0.74|0.494
71740444|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||<0.0001
71740445|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16||||0.0313
71740446|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||<0.0001
71740447|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0019
71740448|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0781|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20||||0.0781
71740449|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||<0.0001
71740450|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.0001
71740451|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.1279|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24||||0.1279
71740452|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||<0.0001
71740453|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0004
71740454|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32||||0.0807
71740455|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||<0.0001
71775574|NCT01675427|143051157|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71740456|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.0002
71890735|NCT00046228|143303122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.338||95.0|0.79|1.95|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.||1.95|0.79|0.338
71740457|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.418|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40||||0.4180
71740458|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||<0.0001
71740459|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0061|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.0061
71775575|NCT01675427|143051157|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0330
71890736|NCT00046228|143303122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.781||95.0|0.61|1.45|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.||1.45|0.61|0.781
71740460|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.1615|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48||||0.1615
71740461|NCT00445770|142992942|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||<0.0001
71740462|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0130
71740463|NCT00445770|142992942|SUPERIORITY_OR_OTHER|||||||0.0948|TWO_SIDED||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52||||0.0948
71740464|NCT03857542|142992944|SUPERIORITY||Percentage Difference|15.2|||<|0.0001|TWO_SIDED|95.0|7.7|22.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||22.7|7.7|<.0001
71740465|NCT03857542|142992945|SUPERIORITY||Percentage Difference|6.5||||0.0548|TWO_SIDED|95.0|-0.1|13.1||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||13.1|-0.1|0.0548
71740466|NCT03857542|142992946|SUPERIORITY||Percentage Difference|5.9||||0.0693|TWO_SIDED|95.0|-0.5|12.2||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. The 95% confidence intervals for the proportion difference was calculated based on the normal approximation based on pooled variance without continuity correction.|||12.2|-0.5|0.0693
71740467|NCT03857542|142992947|SUPERIORITY||Least Squares (LS) Mean Difference|4.1|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|2.9|5.2||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value; Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||5.2|2.9|<.0001
71740468|NCT03857542|142992948|SUPERIORITY||Percentage Difference|9.9||||0.0141|TWO_SIDED|95.0|3.5|16.3||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||16.3|3.5|0.0141
71775576|NCT01675427|143051157|SUPERIORITY_OR_OTHER|||||||0.1595|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.1595
71775577|NCT01675427|143051157|SUPERIORITY_OR_OTHER|||||||0.0412|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0412
71833820|NCT04714320|143171965|SUPERIORITY||||||=|0.047||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.047
71833821|NCT04714320|143171965|SUPERIORITY||||||=|0.95||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 64||||=0.950
71833822|NCT04714320|143171965|SUPERIORITY||||||=|0.656||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.656
71833823|NCT04714320|143171965|SUPERIORITY||||||=|0.922||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 71||||=0.922
71833824|NCT04714320|143171965|SUPERIORITY||||||=|0.143||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.143
71833825|NCT04714320|143171965|SUPERIORITY||||||=|0.452||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 78||||=0.452
71833826|NCT04714320|143171965|SUPERIORITY||||||=|0.231||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.231
71833827|NCT04714320|143171965|SUPERIORITY||||||=|0.405||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 85||||=0.405
71833828|NCT04714320|143171965|SUPERIORITY||||||=|0.718||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.718
71890737|NCT00046228|143303123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.016||95.0|1.08|2.1|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||2.10|1.08|0.016
71661752|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).||||<0.01
71775578|NCT01675427|143051158|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
71775579|NCT01675427|143051158|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0421
71775580|NCT01675427|143051158|SUPERIORITY_OR_OTHER|||||||0.7658|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7658
71775581|NCT01675427|143051158|SUPERIORITY_OR_OTHER|||||||0.295|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.2950
71775582|NCT01675427|143051159|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1||||< 0.0001
71833829|NCT04714320|143171965|SUPERIORITY||||||=|0.053||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 92||||=0.053
71833830|NCT04714320|143171965|SUPERIORITY||||||=|0.893||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.893
71833831|NCT04714320|143171965|SUPERIORITY||||||=|0.662||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 106||||=0.662
71890738|NCT00046228|143303123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.67||95.0|0.76|1.52|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution \>70% from baseline.||1.52|0.76|0.670
71775583|NCT01675427|143051159|SUPERIORITY_OR_OTHER|||||||0.0827|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2||||0.0827
71775584|NCT01675427|143051159|SUPERIORITY_OR_OTHER|||||||0.7817|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3||||0.7817
71775585|NCT01675427|143051159|SUPERIORITY_OR_OTHER|||||||0.1986|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4||||0.1986
71775586|NCT01675427|143051160|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71775587|NCT01675427|143051160|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0002
71775588|NCT01675427|143051160|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.0394
71775589|NCT01675427|143051160|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.0493
71775590|NCT01675427|143051161|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1||||< 0.0001
71890739|NCT00046228|143303123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.042||95.0|1.01|1.93|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution \>70% from baseline.||1.93|1.01|0.042
71890740|NCT00046228|143303124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.603||95.0|0.62|1.32|||Log Rank|||||1.32|0.62|0.603
71890741|NCT00046228|143303124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.765||95.0|0.73|1.52|||Log Rank|||||1.52|0.73|0.765
71775591|NCT01675427|143051161|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2||||0.0196
71775592|NCT01675427|143051161|SUPERIORITY_OR_OTHER|||||||0.3268|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3||||0.3268
71775593|NCT01675427|143051161|SUPERIORITY_OR_OTHER|||||||0.1667|TWO_SIDED|||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4||||0.1667
71775594|NCT01675427|143051162|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0021
71775595|NCT01675427|143051162|SUPERIORITY_OR_OTHER|||||||0.5319|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.5319
71775596|NCT01675427|143051162|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.0114
71775597|NCT01675427|143051162|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2293
71775598|NCT01675427|143051162|SUPERIORITY_OR_OTHER|||||||0.2857|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2857
71775599|NCT01675427|143051162|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0001
71890742|NCT00046228|143303124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.415||95.0|0.59|1.24|||Log Rank|||||1.24|0.59|0.415
71890743|NCT00046228|143303125|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.218
71775600|NCT01675427|143051163|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0081
71775601|NCT01675427|143051163|SUPERIORITY_OR_OTHER|||||||0.0563|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.0563
71775602|NCT01675427|143051163|SUPERIORITY_OR_OTHER|||||||0.3516|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3516
71775603|NCT01675427|143051163|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.0064
71775604|NCT01675427|143051163|SUPERIORITY_OR_OTHER|||||||0.2707|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.2707
71775605|NCT01675427|143051163|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||< 0.0001
71775606|NCT01675427|143051164|SUPERIORITY_OR_OTHER|||||||0.0634|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.0634
71890744|NCT00046228|143303125|SUPERIORITY_OR_OTHER|||||||0.497||95.0|||||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.||||0.497
71890745|NCT00046228|143303125|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.||||0.062
71890746|NCT00046228|143303126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.001||95.0|1.63|3.19|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||3.19|1.63|<0.001
71890747|NCT00046228|143303126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.025||95.0|1.05|2.15|||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.||2.15|1.05|0.025
71890748|NCT00046228|143303126|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.008||95.0|1.12|2.05|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.||2.05|1.12|0.008
71890749|NCT00046228|143303127|SUPERIORITY_OR_OTHER|||||||0.439||95.0|||||Fisher Exact|||||||0.439
71775607|NCT01675427|143051164|SUPERIORITY_OR_OTHER|||||||0.7176|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.7176
71661753|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).||||<0.01
71661754|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale||||<0.01
71661755|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).||||<0.01
71661756|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).||||<0.01
71661757|NCT01781481|142836767|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).||||<0.01
71661758|NCT01781481|142836768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.33|||||TWO_SIDED|95.0|2.02|34.47||||||||34.47|2.02|
71661759|NCT01781481|142836769|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.52|||||TWO_SIDED|95.0|1.7|43.02||||||||43.02|1.70|
71661760|NCT01781481|142836770|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.27|||||TWO_SIDED|95.0|2.17|24.36||||||||24.36|2.17|
71661761|NCT01781481|142836771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.79|||||TWO_SIDED|95.0|5.0|122.84||||||||122.84|5.00|
71661762|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.||||<0.01
71661763|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.||||<0.01
71661764|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.||||<0.01
71661765|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being||||<0.01
71775608|NCT01675427|143051164|SUPERIORITY_OR_OTHER|||||||0.3944|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.3944
71775609|NCT01675427|143051164|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.8610
71775610|NCT01675427|143051164|SUPERIORITY_OR_OTHER|||||||0.4543|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.4543
71890750|NCT00046228|143303127|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Fisher Exact|||||||0.438
71890751|NCT00046228|143303127|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
71890752|NCT00046228|143303128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71890753|NCT00046228|143303128|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||||||0.020
71890754|NCT00046228|143303128|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71890755|NCT00046228|143303129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.434||95.0|0.69|1.18|||Chi-squared|||||1.18|0.69|0.434
71890756|NCT00046228|143303129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.589||95.0|0.71|1.22|||Chi-squared|||||1.22|0.71|0.589
71890757|NCT00046228|143303129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.809||95.0|0.74|1.27|||Chi-squared|||||1.27|0.74|0.809
71661766|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
71661767|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||<0.01
71661768|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis."||||<0.01
71661769|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being."||||<0.01
71661770|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
71661771|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
71890758|NCT04068103|143303130|SUPERIORITY|||||||0.98||||||P value \<= 0.35 moves trial to phase III, \>0.35 stops trial for futility. Decision rule calls for early stopping due to futility.|Fisher Exact|||One-sided Fisher's Exact Test of ctDNA clearance by treatment arm.||||0.98
71890759|NCT02732951|143303138|OTHER||Adjusted Mean|16.45|STANDARD_ERROR_OF_MEAN|16.45||0.3199|TWO_SIDED|95.0|-16.23|49.13|||Mixed model for repeated measurements|Kenward-Roger approximation was used for denominator degrees of freedom.|Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.|Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups||49.13|-16.23|0.3199
71890760|NCT00371267|143303144|SUPERIORITY_OR_OTHER||||||<|0.27|TWO_SIDED||||||Mixed Models Analysis|||||||<0.27
71890761|NCT00371267|143303145|SUPERIORITY_OR_OTHER||||||<|0.35|TWO_SIDED||||||Mixed Models Analysis|||||||<0.35
71740469|NCT03857542|142992949|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.5|1.0||Analysis of covariance (ANCOVA) with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control||||1.0|0.5|<.0001
71740470|NCT03857542|142992950|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001|TWO_SIDED|95.0|2.4|4.4||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||4.4|2.4|<.0001
71740471|NCT03857542|142992951|SUPERIORITY||Percentage Difference|3.8||||0.22|TWO_SIDED|95.0|-2.3|10.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals for the proportion differences were calculated based on the normal approximation based on pooled variance without continuity correction.|||10.0|-2.3|0.2200
71740472|NCT03857542|142992952|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|1.5|3.7||MMRM with study intervention group, visit, visit by study intervention group interaction, age group, Baseline binocular DCNVA severity, iris color, emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction as fixed effects.|MMRM|P-value was adjusted for multiplicity control.||||3.7|1.5|<.0001
71740473|NCT03857542|142992953|SUPERIORITY||Percentage Difference|12.4||||0.0141|TWO_SIDED|95.0|5.2|19.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using chi-square test. The 95% confidence intervals was calculated based on normal approximation based on pooled variance without continuity correction.|||19.5|5.2|0.0141
71740474|NCT03857542|142992954|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|0.5|1.0||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.0|0.5|<.0001
71775611|NCT01675427|143051164|SUPERIORITY_OR_OTHER|||||||0.0406|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.0406
71775612|NCT01675427|143051165|SUPERIORITY_OR_OTHER|||||||0.8234|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1||||0.8234
71775613|NCT01675427|143051165|SUPERIORITY_OR_OTHER|||||||0.2427|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2||||0.2427
71890762|NCT00371267|143303146|SUPERIORITY_OR_OTHER||||||<|0.74|TWO_SIDED||||||Mixed Models Analysis|||||||<0.74
71890763|NCT00371267|143303147|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
71890764|NCT00371267|143303148|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71890765|NCT01575912|143303216|OTHER|||||||0.121||||||using Mann Whitney test|Wilcoxon (Mann-Whitney)|||||||0.121
71890766|NCT01542307|143303218|SUPERIORITY_OR_OTHER|||||||0.674|||||||Wilcoxon (Mann-Whitney)|||||||0.674
71890767|NCT01542307|143303219|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71890768|NCT01542307|143303220|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71890769|NCT01542307|143303221|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71890770|NCT01542307|143303222|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71890771|NCT01542307|143303223|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
71890772|NCT01542307|143303224|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71775614|NCT01675427|143051165|SUPERIORITY_OR_OTHER|||||||0.4805|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3||||0.4805
71890773|NCT01542307|143303225|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
71890774|NCT00961532|143303229|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.||||0.014
71890775|NCT02216695|143303289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.3|1.4|||Regression, Logistic||This is OR for 65 to 74 years age group with \< 65 years as the reference group|||1.40|1.30|
71890776|NCT02216695|143303289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.66|1.79|||Regression, Logistic||This is OR for age group 75 to 84 years age group with \< 65 years as reference|||1.79|1.66|
71890777|NCT02216695|143303289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|1.89|2.19|||Regression, Logistic||This is OR for age group equal to greater than 85 years age group with \< 65 years as reference|||2.19|1.89|
71890778|NCT02216695|143303290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.1|1.3|||Regression, Logistic||This is the OR for 1998-2003 discharge period with 2003-08 as the reference group|||1.30|1.10|
71890779|NCT02216695|143303290|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|1.07|1.18|||Regression, Logistic||This is the OR for 2008-13 discharge period with 2003-08 as the reference group|||1.18|1.07|
71890780|NCT01903876|143303307|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.044|||||||ANCOVA|||||||.044
71890781|NCT01903876|143303308|NON_INFERIORITY_OR_EQUIVALENCE|equivalence||||||0.042|||||||ANCOVA|||||||.042
71775615|NCT01675427|143051165|SUPERIORITY_OR_OTHER|||||||0.2901|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4||||0.2901
71775616|NCT01675427|143051165|SUPERIORITY_OR_OTHER|||||||0.3927|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes||||0.3927
71775617|NCT01675427|143051165|SUPERIORITY_OR_OTHER|||||||0.5769|TWO_SIDED|||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes||||0.5769
71775618|NCT00700570|143051168|SUPERIORITY_OR_OTHER|||||||0.1341|TWO_SIDED||||||Log Rank|||||||0.1341
71775619|NCT00700570|143051170|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.0010
71775620|NCT01461980|143051209|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03||||||Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).||1.03|0.86|
71775621|NCT01461980|143051209|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.85|0.99||||||Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).||0.99|0.85|
71775622|NCT01461980|143051210|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.02||||||Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).||1.02|0.85|
71775623|NCT01461980|143051210|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98||||||Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).||0.98|0.84|
71661772|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis."||||>0.05
71661773|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being."||||>0.05
71833832|NCT04714320|143171965|SUPERIORITY||||||=|0.688||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.688
71833833|NCT04714320|143171965|SUPERIORITY||||||=|0.611||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 120||||=0.611
71775624|NCT01461980|143051210|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.98||||||Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).||0.98|0.80|
71775625|NCT01461980|143051210|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.08||||||Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).||1.08|0.74|
71775626|NCT01461980|143051211|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.82|1.01||||||Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).||1.01|0.82|
71833834|NCT04714320|143171965|SUPERIORITY||||||=|0.907||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.907
71833835|NCT04714320|143171965|SUPERIORITY||||||=|0.699||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 148||||=0.699
71890782|NCT02811744|143303309|EQUIVALENCE|Equivalence was defined as no significant difference between study groups on a T-test.||||||0.5||||||No adjustments on the comparison. There was no multiple comparison adjustment for the p value, as this was the primary outcome. This is the experimental p value; the threshold for significance was 0.05.|t-test, 2 sided|||No power calculation. This is an exploratory study.||||0.5
71890783|NCT00450580|143303365|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -12%.|Risk Difference (RD)|-0.9||||||95.0|-11.4|9.5||||||||9.5|-11.4|
71890784|NCT00393718|143303373|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.|Least Squares Mean|-0.5|||<|0.0001||95.0|-0.7|-0.3||p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.~Hypothesis for non-inferiority:~H0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG \< 0.4,~Hypothesis for superiority:~H0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG \< 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure."||-0.30|-0.70|<0.0001
71890785|NCT00393718|143303374|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.49||||||95.0|-0.71|-0.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.27|-0.71|
71890786|NCT00393718|143303375|SUPERIORITY_OR_OTHER||Least Squares Mean|-12.9|||<|0.0001||95.0|-18.2|-7.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-7.5|-18.2|<0.0001
71890787|NCT00393718|143303376|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||||95.0|-18.6|-4.9|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.9|-18.6|
71890788|NCT00393718|143303377|SUPERIORITY_OR_OTHER||Least Squares Mean|-93.05|||<|0.0001||95.0|-119.61|-66.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-66.50|-119.61|<0.0001
71890789|NCT00393718|143303378|SUPERIORITY_OR_OTHER||Least Squares Mean|-74.51||||||95.0|-105.75|-43.27|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-43.27|-105.75|
71890790|NCT00393718|143303379|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.63|||<|0.0001||95.0|-25.0|-10.27||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-10.27|-25.00|<0.0001
71890791|NCT00393718|143303380|SUPERIORITY_OR_OTHER||Least Squares Mean|-17.21||||||95.0|-26.32|-8.09|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-8.09|-26.32|
71890792|NCT00393718|143303381|SUPERIORITY_OR_OTHER||Least Squares Mean|-19.97|||<|0.0001||95.0|-27.99|-11.94||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-11.94|-27.99|<0.0001
71890793|NCT00393718|143303382|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.03||||||95.0|-21.46|-4.6|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-4.60|-21.46|
71890794|NCT00393718|143303383|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.91|||<|0.0001||95.0|-2.34|-1.48||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.||-1.48|-2.34|<0.0001
71890795|NCT00393718|143303384|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.71||||||95.0|-2.25|-1.18|||ANOVA|||95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.18|-2.25|
71890796|NCT00393718|143303385|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.12|0.35|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.35|0.12|
71740475|NCT03857542|142992955|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08||0.0002|TWO_SIDED|95.0|-0.5|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.5|0.0002
71740476|NCT03857542|142992956|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.2||ANCOVA with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.2|-0.4|0.0002
71740477|NCT04255862|142992986|EQUIVALENCE|Bioequivalence (BE) was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|103.4|||||TWO_SIDED|90.0|86.4|123.8||||||||123.8|86.4|
71740478|NCT04255862|142992986|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC.|Geometric Mean Ratio|115.0|||||TWO_SIDED|90.0|97.9|135.0||||||||135.0|97.9|
71740479|NCT04255862|142992987|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|102.8|||||TWO_SIDED|90.0|87.0|121.5||||||||121.5|87.0|
71740480|NCT04255862|142992987|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for AUC0-t.|Geometric Mean Ratio|113.4|||||TWO_SIDED|90.0|97.4|131.9||||||||131.9|97.4|
71740481|NCT04255862|142992988|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|104.0|||||TWO_SIDED|90.0|90.3|119.7||||||||119.7|90.3|
71890797|NCT00393718|143303385|SUPERIORITY_OR_OTHER||Rate ratio|0.18||||||95.0|0.09|0.36|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.36|0.09|
71740482|NCT04255862|142992988|EQUIVALENCE|BE was concluded if the 90% CIs for the ratio of the respective comparison are fully included in the acceptance range from 80 to 125 for Cmax.|Geometric Mean Ratio|114.3|||||TWO_SIDED|90.0|99.5|131.4||||||||131.4|99.5|
71661774|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
71740483|NCT01724866|142993016|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.72||||0.296|TWO_SIDED|95.0|0.19|1.27|||Bootstrap method|||A 2-sided 95% confidence interval (CI) for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||1.27|0.19|0.296
71740484|NCT01724866|142993016|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.14||||0.002|TWO_SIDED|95.0|-0.28|0.64|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.64|-0.28|0.002
71740485|NCT01724866|142993016|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.56|-0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-values was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||-0.06|-0.56|<0.001
71740486|NCT01724866|142993017|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.38||||0.001|TWO_SIDED|95.0|0.06|0.74|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.74|0.06|0.001
71740487|NCT01724866|142993017|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.04|||<|0.001|TWO_SIDED|95.0|-0.16|0.24|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.24|-0.16|<0.001
71740488|NCT01724866|142993017|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.19|0.06|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.06|-0.19|<0.001
71740489|NCT01724866|142993018|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.31||||0.002|TWO_SIDED|95.0|-0.07|0.72|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.72|-0.07|0.002
71740490|NCT01724866|142993018|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.02|||<|0.001|TWO_SIDED|95.0|-0.27|0.3|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.30|-0.27|<0.001
71740491|NCT01724866|142993018|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.27|0.28|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.28|-0.27|<0.001
71740492|NCT01724866|142993019|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.94||||0.781|TWO_SIDED|95.0|-0.01|2.47|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||2.47|-0.01|0.781
71890798|NCT00393718|143303385|SUPERIORITY_OR_OTHER||Rate ratio|0.2||||||95.0|0.11|0.34|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||0.34|0.11|
71661775|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis."||||>0.05
71661776|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
71661777|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being."||||<0.01
71661778|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."||||<0.01
71661779|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis."||||>0.05
71661780|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis."||||>0.05
71661781|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being."||||>0.05
71661782|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care."||||>0.05
71661783|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care."||||<0.01
71661784|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis."||||>0.05
71661785|NCT01781481|142836772|SUPERIORITY_OR_OTHER||||||<|0.01||||||The threshold for significance is p\<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being."||||<0.01
71661786|NCT01781481|142836773|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.08|||<|0.01|TWO_SIDED|||||p\<0.05 Threshold for statistical significance|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
71661787|NCT01781481|142836774|SUPERIORITY_OR_OTHER||R2Change|0.05|||<|0.01|TWO_SIDED|||||Threshold for statistical significance is p\<0.01|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
71661788|NCT01781481|142836775|SUPERIORITY_OR_OTHER||Rsquare change statistic|0.05|||<|0.01|TWO_SIDED|||||p\<.05 threshold for statistical significance|Regression, Linear|Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).||||<0.01
71661789|NCT01781481|142836776|SUPERIORITY_OR_OTHER||R2Change|0.03|||<|0.05|TWO_SIDED|||||Threshold for statistical significance is p \<0.05.|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.05
71890799|NCT03293654|143303400|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.28|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.18|1.39|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.39|1.18|
71661790|NCT01781481|142836777|SUPERIORITY_OR_OTHER||R2Change|0.07|||<|0.01|TWO_SIDED||||||Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||||<0.01
71775627|NCT01461980|143051211|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).||1.15|0.90|
71775628|NCT01461980|143051211|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.89|1.09||||||Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).||1.09|0.89|
71775629|NCT01461980|143051211|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).||1.04|0.83|
71775630|NCT01461980|143051212|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02||||||PMB80 \[A22\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.02|0.84|
71775631|NCT01461980|143051212|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.82|1.0||||||PMB2948 \[B24\]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).||1.00|0.82|
71775632|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.28|-0.57|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.28|<0.001
71833836|NCT04714320|143171965|SUPERIORITY||||||=|0.802||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.802
71833837|NCT04714320|143171965|SUPERIORITY||||||=|0.206||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 140 mmHg and DBP ≤ 90 mmHg at Day 169||||=0.206
71775633|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
71775634|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.94|-0.23|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.94|0.001
71775635|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.015|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.015
71775636|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.453|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.453
71775637|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.177|TWO_SIDED|95.0|-0.61|0.11|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.61|0.177
71775638|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.7|0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.70|0.062
71775639|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.212|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.59|0.212
71775640|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.34|-0.54|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.54|-1.34|<0.001
71775641|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.35|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.35|-1.15|<0.001
71775642|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.2||0.004|TWO_SIDED|95.0|-0.98|-0.18|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.98|0.004
71775643|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.95|-0.15|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.95|0.007
71661791|NCT04086407|142836778|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
71661792|NCT04086407|142836779|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
71661793|NCT04086407|142836780|OTHER||||||||||||||||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||
71661794|NCT04086407|142836781|OTHER||||||<|0.05|||||||t-test, 2 sided||||All statistical tests were completed with a significance of p \< 0.05 and 95% confidence intervals. Sample sets were statistically compared and analyzed by using two-tailed, unpaired Student t test analyses of means.|||<.05
71661795|NCT02684630|142836782|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
71661796|NCT02684630|142836783|OTHER|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|||0.951|
71661797|NCT01284361|142836796|SUPERIORITY_OR_OTHER||Proportion|91.5|||||TWO_SIDED|95.0|84.5|97.5|||||Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.|The sample size of 81 subjects provides a 10.8% margin of error.||97.5|84.5|
71661798|NCT00325195|142836831|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71661799|NCT00325195|142836831|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71661800|NCT00325195|142836832|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||Fisher Exact|||||||<0.002
71661801|NCT00325195|142836832|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.200
71661802|NCT00325195|142836833|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Fisher Exact|||% of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.007
71661803|NCT00325195|142836833|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Fisher Exact|||% of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period||||0.321
71661804|NCT00325195|142836834|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||t-test, 2 sided|||||||0.166
71661805|NCT00325195|142836834|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||||||0.170
71661806|NCT00325195|142836835|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
71661807|NCT00325195|142836835|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
71661808|NCT04715932|142836857|SUPERIORITY||Odds Ratio (OR)|1.49||||0.3849|TWO_SIDED|95.0|0.6|3.69|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression).||||3.69|0.60|0.3849
71661809|NCT04715932|142836858|SUPERIORITY||Odds Ratio (OR)|1.43||||0.3139|TWO_SIDED|95.0|0.71|2.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.88|0.71|0.3139
71661810|NCT04715932|142836859|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5886|TWO_SIDED|95.0|0.65|2.14|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.14|0.65|0.5886
71661811|NCT04715932|142836860|SUPERIORITY||Odds Ratio (OR)|0.69||||0.2328|TWO_SIDED|95.0|0.38|1.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.27|0.38|0.2328
71661812|NCT04715932|142836861|SUPERIORITY||Rate Ratio|1.14||||0.156|TWO_SIDED|95.0|0.95|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression).||||1.37|0.95|0.1560
71661813|NCT04715932|142836862|SUPERIORITY||Rate Ratio|1.06||||0.6233|TWO_SIDED|95.0|0.84|1.33|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.33|0.84|0.6233
71661814|NCT04715932|142836863|SUPERIORITY||Rate Ratio|1.03||||0.829|TWO_SIDED|95.0|0.78|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.37|0.78|0.8290
71661815|NCT04715932|142836864|SUPERIORITY||Rate Ratio|0.98||||0.9222|TWO_SIDED|95.0|0.69|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated poisson regression)||||1.40|0.69|0.9222
71661816|NCT04715932|142836865|SUPERIORITY|||||||0.8834|||||||Log Rank|||||||0.8834
71661817|NCT04715932|142836866|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9416|TWO_SIDED|95.0|0.59|1.77|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.77|0.59|0.9416
71661818|NCT04715932|142836867|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6296|TWO_SIDED|95.0|0.49|1.55|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.55|0.49|0.6296
71661819|NCT04715932|142836868|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3711|TWO_SIDED|95.0|0.41|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.41|0.3711
71661820|NCT04715932|142836869|SUPERIORITY||Odds Ratio (OR)|0.82||||0.5696|TWO_SIDED|95.0|0.42|1.61|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.61|0.42|0.5696
71661821|NCT04715932|142836870|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7583|TWO_SIDED|95.0|0.26|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.26|0.7583
71775644|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.879|TWO_SIDED|95.0|-0.43|0.37|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.37|-0.43|0.879
71775645|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.60|0.330
71775646|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.083|TWO_SIDED|95.0|-0.75|0.05|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.75|0.083
71775647|NCT00809354|143051250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.36|TWO_SIDED|95.0|-0.59|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.59|0.360
71775648|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.23|-0.53|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.23|<0.001
71775649|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.13|-0.43|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.13|<0.001
71775650|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.87|0.003
71775651|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.83|-0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.83|0.007
71775652|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.824|TWO_SIDED|95.0|-0.39|0.31|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.39|0.824
71775653|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.18||0.1|TWO_SIDED|95.0|-0.64|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.64|0.100
71775654|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.044|TWO_SIDED|95.0|-0.7|-0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.70|0.044
71833838|NCT04714320|143171966|SUPERIORITY||||||=|0.28||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.280
71833839|NCT04714320|143171966|SUPERIORITY||||||=|0.648||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 8||||=0.648
71775655|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.565|TWO_SIDED|95.0|-0.45|0.25|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.45|0.565
71775656|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.4|-0.62|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.40|<0.001
71775657|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
71775658|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
71775659|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.02|-0.24|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-1.02|0.002
71775660|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.98|TWO_SIDED|95.0|-0.39|0.4|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.40|-0.39|0.980
71775661|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.383|TWO_SIDED|95.0|-0.56|0.22|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.56|0.383
71775662|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.057|TWO_SIDED|95.0|-0.77|0.01|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.77|0.057
71775663|NCT00809354|143051251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.312|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.59|0.312
71775664|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.008|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.008
71775665|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
71775666|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.251|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.22|0.251
71775667|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.961|TWO_SIDED|95.0|-0.14|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.14|0.961
71661822|NCT04715932|142836871|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8091|TWO_SIDED|95.0|0.2|3.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.58|0.20|0.8091
71833840|NCT04714320|143171966|SUPERIORITY||||||=|0.416||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.416
71833841|NCT04714320|143171966|SUPERIORITY||||||=|0.9||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 15||||=0.900
71833842|NCT04714320|143171966|SUPERIORITY||||||=|0.627||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.627
71833843|NCT04714320|143171966|SUPERIORITY||||||=|0.921||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 22||||=0.921
71833844|NCT04714320|143171966|SUPERIORITY||||||=|0.464||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.464
71833845|NCT04714320|143171966|SUPERIORITY||||||=|0.458||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 29||||=0.458
71833846|NCT04714320|143171966|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.779
71833847|NCT04714320|143171966|SUPERIORITY||||||=|0.629||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 36||||=0.629
71833848|NCT04714320|143171966|SUPERIORITY||||||=|0.242||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.242
71833849|NCT04714320|143171966|SUPERIORITY||||||=|0.29||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 43||||=0.290
71833850|NCT04714320|143171966|SUPERIORITY||||||=|0.349||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.349
71833851|NCT04714320|143171966|SUPERIORITY||||||=|0.532||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 50||||=0.532
71833852|NCT04714320|143171966|SUPERIORITY||||||=|0.205||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.205
71833853|NCT04714320|143171966|SUPERIORITY||||||=|0.368||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 57||||=0.368
71661823|NCT04715932|142836872|SUPERIORITY||Odds Ratio (OR)|1.67||||0.5591|TWO_SIDED|95.0|0.3|9.42|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||9.42|0.30|0.5591
71775668|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.272|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.272
71775669|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.271|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.271
71775670|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.128
71775671|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.133|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.133
71740493|NCT01724866|142993019|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|0.07|||<|0.001|TWO_SIDED|95.0|-0.17|0.38|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.38|-0.17|<0.001
71740494|NCT01724866|142993019|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI was \< 1 day.|Mean Difference (Final Values)|-0.02|||<|0.001|TWO_SIDED|95.0|-0.23|0.22|||Bootstrap method|||A 2-sided 95% CI for the difference in mean DSN between any 2 arms was calculated. Non-inferiority p-value was calculated as two times the proportion of treatment difference greater than 1 in the resampling.||0.22|-0.23|<0.001
71740495|NCT01724866|142993020|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.002|TWO_SIDED|95.0|1.1|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|1.1|0.002
71775672|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.002
71775673|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.34|-0.06|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.34|0.004
71775674|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.414|TWO_SIDED|95.0|-0.2|0.08|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.20|0.414
71775675|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.057|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.057
71775676|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.277|TWO_SIDED|95.0|-0.06|0.21|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.06|0.277
71775677|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.328|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.328
71890800|NCT03293654|143303400|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.03|1.22|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.22|1.03|
71740496|NCT01724866|142993020|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.711|TWO_SIDED|95.0|0.6|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.6|0.711
71740497|NCT01724866|142993020|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.028|TWO_SIDED|95.0|0.1|0.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||0.9|0.1|0.028
71740498|NCT01724866|142993021|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.672|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.672
71740499|NCT01724866|142993021|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.348|TWO_SIDED|95.0|0.5|1.3|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.3|0.5|0.348
71740500|NCT01724866|142993021|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.973|TWO_SIDED|95.0|0.4|2.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.9|0.4|0.973
71775678|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.30|0.026
71775679|NCT00809354|143051252|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.864|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.864
71775680|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
71775681|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
71775682|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
71775683|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
71775684|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
71775685|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
71661824|NCT04715932|142836873|SUPERIORITY|||||||0.9983|||||||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||||0.9983
71833854|NCT04714320|143171966|SUPERIORITY||||||=|0.084||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.084
71833855|NCT04714320|143171966|SUPERIORITY||||||=|0.179||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 64||||=0.179
71833856|NCT04714320|143171966|SUPERIORITY||||||=|0.584||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.584
71833857|NCT04714320|143171966|SUPERIORITY||||||=|0.762||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 71||||=0.762
71833858|NCT04714320|143171966|SUPERIORITY||||||=|0.675||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.675
71833859|NCT04714320|143171966|SUPERIORITY||||||=|0.166||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 78||||=0.166
71833860|NCT04714320|143171966|SUPERIORITY||||||=|0.09||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.090
71661825|NCT04715932|142836874|SUPERIORITY||Odds Ratio (OR)|1.6||||0.1068|TWO_SIDED|95.0|0.9|2.82|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.82|0.90|0.1068
71833861|NCT04714320|143171966|SUPERIORITY||||||=|0.488||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 85||||=0.488
71833862|NCT04714320|143171966|SUPERIORITY||||||=|0.218||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.218
71833863|NCT04714320|143171966|SUPERIORITY||||||=|0.232||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 92||||=0.232
71890801|NCT03293654|143303400|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.14|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.05|1.24|||||Ratio of GLSM, EU is the numerator and US Avastin acts as the denominator|||1.24|1.05|
71740501|NCT01724866|142993022|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.618|TWO_SIDED|95.0|0.8|1.4|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.4|0.8|0.618
71833864|NCT04714320|143171966|SUPERIORITY||||||=|0.421||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.421
71833865|NCT04714320|143171966|SUPERIORITY||||||=|0.815||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 106||||=0.815
71833866|NCT04714320|143171966|SUPERIORITY||||||=|0.711||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.711
71890802|NCT03293654|143303401|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator|1.22|1.09|
71661826|NCT04715932|142836875|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8382|TWO_SIDED|95.0|0.57|1.98|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.98|0.57|0.8382
71661827|NCT04715932|142836876|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5912|TWO_SIDED|95.0|0.59|2.51|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.51|0.59|0.5912
71661828|NCT04715932|142836878|SUPERIORITY||Odds Ratio (OR)|0.78||||0.3686|TWO_SIDED|95.0|0.45|1.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.35|0.45|0.3686
71740502|NCT01724866|142993022|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.661|TWO_SIDED|95.0|0.5|1.6|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.6|0.5|0.661
71740503|NCT01724866|142993022|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.754|TWO_SIDED|95.0|0.3|2.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||2.8|0.3|0.754
71740504|NCT01724866|142993023|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.7|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.7|1.1|0.009
71740505|NCT01724866|142993023|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.527|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||1.8|0.7|0.527
71740506|NCT01724866|142993023|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.815|TWO_SIDED|95.0|0.4|3.9|||Log Rank|||A Cox proportional hazards model was used to estimate the hazard ratio and its two-sided 95% CI.||3.9|0.4|0.815
71775686|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
71775687|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
71775688|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
71775689|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
71661829|NCT04715932|142836879|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8711|TWO_SIDED|95.0|0.59|1.86|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.86|0.59|0.8711
71661830|NCT04715932|142836880|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9124|TWO_SIDED|95.0|0.57|1.87|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.87|0.57|0.9124
71740507|NCT01724866|142993024|SUPERIORITY|||||||0.008|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.008
71740508|NCT01724866|142993024|SUPERIORITY|||||||0.911|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.911
71740509|NCT01724866|142993024|SUPERIORITY|||||||0.002|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.002
71740510|NCT01724866|142993025|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
71740511|NCT01724866|142993025|SUPERIORITY|||||||0.633|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.633
71740512|NCT01724866|142993025|SUPERIORITY|||||||0.027|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.027
71740513|NCT01724866|142993026|SUPERIORITY|||||||0.015|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.015
71740514|NCT01724866|142993026|SUPERIORITY|||||||0.571|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.571
71740515|NCT01724866|142993026|SUPERIORITY|||||||0.066|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.066
71740516|NCT01724866|142993027|SUPERIORITY|||||||0.106|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.106
71740517|NCT01724866|142993027|SUPERIORITY|||||||0.156|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.156
71740518|NCT01724866|142993027|SUPERIORITY|||||||0.005|||||||Asymptotic Normality Assumption|P-values was obtained based upon asymptotic normality assumption on the log10 transformed data.||||||0.005
71740519|NCT01724866|142993028|SUPERIORITY||Ratio|0.4|||||TWO_SIDED|95.0|0.25|0.8||||||||0.80|0.25|
71740520|NCT01724866|142993028|SUPERIORITY||Ratio|1.0|||||TWO_SIDED|95.0|0.53|2.04||||||||2.04|0.53|
71740521|NCT01724866|142993028|SUPERIORITY||Ratio|2.5|||||TWO_SIDED|95.0|1.4|4.54||||||||4.54|1.40|
71740522|NCT01724866|142993029|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.3|0.8||||||||0.80|0.30|
71740523|NCT01724866|142993029|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.7|1.79||||||||1.79|0.70|
71740524|NCT01724866|142993029|SUPERIORITY||Ratio|1.7|||||TWO_SIDED|95.0|1.07|2.79||||||||2.79|1.07|
71740525|NCT01724866|142993030|SUPERIORITY||Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.89||||||||0.89|0.34|
71740526|NCT01724866|142993030|SUPERIORITY||Ratio|1.1|||||TWO_SIDED|95.0|0.71|1.85||||||||1.85|0.71|
71775690|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
71775691|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
71775692|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
71775693|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
71661831|NCT04715932|142836881|SUPERIORITY||Odds Ratio (OR)|0.7||||0.2952|TWO_SIDED|95.0|0.36|1.37|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.37|0.36|0.2952
71661832|NCT04715932|142836882|SUPERIORITY||Odds Ratio (OR)|1.2||||0.5894|TWO_SIDED|95.0|0.62|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.62|0.5894
71661833|NCT04715932|142836883|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7887|TWO_SIDED|95.0|0.45|2.89|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.89|0.45|0.7887
71661834|NCT04715932|142836884|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6348|TWO_SIDED|95.0|0.2|2.7|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.70|0.20|0.6348
71661835|NCT04715932|142836885|SUPERIORITY||Odds Ratio (OR)|0.39||||0.4257|TWO_SIDED|95.0|0.04|3.92|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.92|0.04|0.4257
71661836|NCT04715932|142836886|SUPERIORITY||Odds Ratio (OR)|1.66||||0.1113|TWO_SIDED|95.0|0.89|3.11|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.11|0.89|0.1113
71661837|NCT04715932|142836887|SUPERIORITY||Odds Ratio (OR)|1.57||||0.2613|TWO_SIDED|95.0|0.71|3.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.47|0.71|0.2613
71661838|NCT04715932|142836888|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7273|TWO_SIDED|95.0|0.27|2.49|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.49|0.27|0.7273
71661839|NCT04715932|142836889|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8909|TWO_SIDED|95.0|0.19|4.19|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.19|0.19|0.8909
71661840|NCT04715932|142836890|SUPERIORITY||Odds Ratio (OR)|1.52||||0.1438|TWO_SIDED|95.0|0.87|2.67|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.67|0.87|0.1438
71661841|NCT04715932|142836891|SUPERIORITY||Odds Ratio (OR)|1.38||||0.344|TWO_SIDED|95.0|0.71|2.68|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.68|0.71|0.3440
71661842|NCT04715932|142836892|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5968|TWO_SIDED|95.0|0.58|2.56|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.56|0.58|0.5968
71661843|NCT04715932|142836893|SUPERIORITY||Odds Ratio (OR)|1.52||||0.362|TWO_SIDED|95.0|0.62|3.76|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.76|0.62|0.3620
71661844|NCT04715932|142836894|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0875|TWO_SIDED|95.0|0.91|4.27|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.27|0.91|0.0875
71661845|NCT04715932|142836895|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8397|TWO_SIDED|95.0|0.36|2.32|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.32|0.36|0.8397
71661846|NCT04715932|142836896|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6265|TWO_SIDED|95.0|0.4|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.40|0.6265
71661847|NCT04715932|142836897|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8528|TWO_SIDED|95.0|0.16|8.91|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||8.91|0.16|0.8528
71661848|NCT04715932|142836898|SUPERIORITY||Odds Ratio (OR)|1.34||||0.2983|TWO_SIDED|95.0|0.77|2.35|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.35|0.77|0.2983
71661849|NCT04715932|142836899|SUPERIORITY||Odds Ratio (OR)|1.19||||0.5611|TWO_SIDED|95.0|0.66|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.66|0.5611
71661850|NCT04715932|142836900|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4643|TWO_SIDED|95.0|0.65|2.58|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.58|0.65|0.4643
71661851|NCT04715932|142836901|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5063|TWO_SIDED|95.0|0.53|3.62|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.62|0.53|0.5063
71661852|NCT04715932|142836902|SUPERIORITY||Odds Ratio (OR)|1.41||||0.2292|TWO_SIDED|95.0|0.8|2.47|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.47|0.80|0.2292
71661853|NCT04715932|142836903|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6097|TWO_SIDED|95.0|0.65|2.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.07|0.65|0.6097
71661854|NCT04715932|142836904|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8389|TWO_SIDED|95.0|0.54|2.16|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.16|0.54|0.8389
71661855|NCT04715932|142836905|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9764|TWO_SIDED|95.0|0.45|2.17|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.17|0.45|0.9764
71661856|NCT04715932|142836906|SUPERIORITY||Odds Ratio (OR)|0.8||||0.4403|TWO_SIDED|95.0|0.46|1.4|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.40|0.46|0.4403
71661857|NCT04715932|142836907|SUPERIORITY||Odds Ratio (OR)|0.79||||0.5112|TWO_SIDED|95.0|0.39|1.6|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.60|0.39|0.5112
71661858|NCT04715932|142836908|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9306|TWO_SIDED|95.0|0.46|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.46|0.9306
71740527|NCT01724866|142993030|SUPERIORITY||Ratio|1.6|||||TWO_SIDED|95.0|0.97|2.49||||||||2.49|0.97|
71740528|NCT01724866|142993031|SUPERIORITY||Ratio|0.7|||||TWO_SIDED|95.0|0.4|1.1||||||||1.10|0.40|
71740529|NCT01724866|142993031|SUPERIORITY||Ratio|1.4|||||TWO_SIDED|95.0|0.87|2.38||||||||2.38|0.87|
71740530|NCT01724866|142993031|SUPERIORITY||Ratio|1.9|||||TWO_SIDED|95.0|1.23|2.96||||||||2.96|1.23|
71740531|NCT01724866|142993036|SUPERIORITY||Percent Difference|2.1||||1|TWO_SIDED|95.0|-20.2|24.9|||Fisher Exact|||||24.9|-20.2|1.000
71740532|NCT01724866|142993036|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
71740533|NCT01724866|142993036|SUPERIORITY||Percent Difference|-2.8||||1|TWO_SIDED|95.0|-26.7|21.4|||Fisher Exact|||||21.4|-26.7|1.000
71740534|NCT01724866|142993038|SUPERIORITY||Percent Difference|-6.2||||0.469|TWO_SIDED|95.0|-28.5|16.9|||Fisher Exact|||||16.9|-28.5|0.469
71740535|NCT01724866|142993038|SUPERIORITY||Percent Difference|-5.6||||0.71|TWO_SIDED|95.0|-29.3|18.7|||Fisher Exact|||||18.7|-29.3|0.710
71740536|NCT01724866|142993038|SUPERIORITY||Percent Difference|-11.1||||0.199|TWO_SIDED|95.0|-34.6|13.3|||Fisher Exact|||||13.3|-34.6|0.199
71775694|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
71775695|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
71661859|NCT04715932|142836909|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6046|TWO_SIDED|95.0|0.23|2.36|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.36|0.23|0.6046
71740537|NCT01980095|142993070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||One-sample Z-test, RHB-105 subjects only|||||||0.001
71740538|NCT02974257|142993080|OTHER|Linear mixed-effects model with an independent variance-covariance matrix to account for the correlation of within-patient repeated measures was used and linear contrasts were used to estimate the mean difference between treatment arms at 48 hours.|Mean Difference (Final Values)|1.5||||0.9|TWO_SIDED|95.0|-3.1|6.1||Global p-value from the mixed model.|Mixed Models Analysis|If patients died before 48 hours lactate levels were imputed by carrying forward the last known value before the event with a 20% increase||||6.1|-3.1|0.9
71740539|NCT02974257|142993081|OTHER||Mean Difference (Final Values)|-0.36||||0.42|TWO_SIDED|95.0|-1.29|0.56|||Regression, Linear|||AUC-VO2 normally distributed, used a linear regression model to compare mean AUC-VO2 between treatment groups controlling for average temperature.||0.56|-1.29|0.42
71740540|NCT02974257|142993082|OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.9|0.3||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between thiamine and placebo groups at 48 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||0.3|-0.9|0.07
71740541|NCT04273893|142993125|OTHER|||||||0.05||||||Changes from baseline ALC were conducted using repeated measures models with an unstructured covariance matrix and model terms for tumor location, follow-up time. Adjustments for stratification factors were made using least squares means.|t-test, 2 sided|||||||0.05
71661860|NCT04715932|142836910|SUPERIORITY||Odds Ratio (OR)|1.15||||0.6963|TWO_SIDED|95.0|0.57|2.34|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||2.34|0.57|0.6963
71740542|NCT03906071|142993127|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.144|TWO_SIDED|95.0|0.7|1.05||The p-value is based on a unstratified log-rank test. (2-Sided)|Log Rank||Based on the unstratified cox proportional hazards model.|||1.05|0.70|0.144
71740543|NCT01957202|142993171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.255|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.616|||Mixed Model ANOVA|||||-1.616|-2.895|<0.0001
71740544|NCT01957202|142993171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.566|||<|0.0001|TWO_SIDED|95.0|-3.208|-1.925|||Mixed Model ANOVA|||||-1.925|-3.208|<0.0001
71740545|NCT01957202|142993171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.531||||0.0003|TWO_SIDED|95.0|-2.342|-0.719|||Mixed Model ANOVA|||||-0.719|-2.342|0.0003
71740546|NCT01957202|142993171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.842|||<|0.0001|TWO_SIDED|95.0|-2.654|-1.029|||Mixed Model ANOVA|||||-1.029|-2.654|<0.0001
71740547|NCT01957202|142993171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.097|||<|0.0001|TWO_SIDED|95.0|-4.857|-3.337|||Mixed Model ANOVA|||||-3.337|-4.857|<0.0001
71740548|NCT01957202|142993171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.3699|TWO_SIDED|95.0|-0.994|0.372|||Mixed Model ANOVA|||||0.372|-0.994|0.3699
71740549|NCT01957202|142993172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.364|||<|0.0001|TWO_SIDED|95.0|-1.853|-0.874|||Mixed Model ANOVA|||||-0.874|-1.853|<0.0001
71740550|NCT01957202|142993172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.1975|TWO_SIDED|95.0|-0.169|0.809|||Mixed Model ANOVA|||||0.809|-0.169|0.1975
71740551|NCT01957202|142993172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.252|||<|0.0001|TWO_SIDED|95.0|-1.87|-0.635|||Mixed Model ANOVA|||||-0.635|-1.870|<0.0001
71740552|NCT01957202|142993172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432||||0.1648|TWO_SIDED|95.0|-0.179|1.042|||Mixed Model ANOVA|||||1.042|-0.179|0.1648
71740553|NCT01957202|142993172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.932||||0.0016|TWO_SIDED|95.0|-1.506|-0.358|||Mixed Model ANOVA|||||-0.358|-1.506|0.0016
71740554|NCT01957202|142993172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|||<|0.0001|TWO_SIDED|95.0|1.16|2.208|||Mixed Model ANOVA|||||2.208|1.160|<0.0001
71740555|NCT01957202|142993173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.3052|TWO_SIDED|95.0|-0.508|0.16|||Mixed Model ANOVA|||||0.160|-0.508|0.3052
71775696|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.17|-0.5|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.50|-1.17|<0.001
71775697|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.22|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.22|<0.001
71740556|NCT01957202|142993173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.2725|TWO_SIDED|95.0|-0.149|0.523|||Mixed Model ANOVA|||||0.523|-0.149|0.2725
71740557|NCT01957202|142993173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.536||||0.0118|TWO_SIDED|95.0|-0.952|-0.12|||Mixed Model ANOVA|||||-0.120|-0.952|0.0118
71740558|NCT01957202|142993173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.175||||0.4049|TWO_SIDED|95.0|-0.588|0.239|||Mixed Model ANOVA|||||0.239|-0.588|0.4049
71740559|NCT01957202|142993173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.349||||0.0793|TWO_SIDED|95.0|-0.739|0.041|||Mixed Model ANOVA|||||0.041|-0.739|0.0793
71775698|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.01|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.01|<0.001
71775699|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.85|0.003
71661861|NCT04715932|142836911|SUPERIORITY||Odds Ratio (OR)|0.65||||0.425|TWO_SIDED|95.0|0.22|1.88|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||1.88|0.22|0.4250
71740560|NCT01957202|142993173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.361||||0.0478|TWO_SIDED|95.0|0.004|0.719|||Mixed Model ANOVA|||||0.719|0.004|0.0478
71740561|NCT01957202|142993174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.215||||0.1502|TWO_SIDED|95.0|-0.509|0.079|||Mixed Model ANOVA|||||0.079|-0.509|0.1502
71740562|NCT01957202|142993174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075||||0.6177|TWO_SIDED|95.0|-0.37|0.221|||Mixed Model ANOVA|||||0.221|-0.370|0.6177
71740563|NCT01957202|142993174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.701||||0.0004|TWO_SIDED|95.0|-1.08|-0.322|||Mixed Model ANOVA|||||-0.322|-1.080|0.0004
71740564|NCT01957202|142993174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0035|TWO_SIDED|95.0|-0.934|-0.187|||Mixed Model ANOVA|||||-0.187|-0.934|0.0035
71740565|NCT01957202|142993174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.775|||<|0.0001|TWO_SIDED|95.0|-1.123|-0.428|||Mixed Model ANOVA|||||-0.428|-1.123|<0.0001
71740566|NCT01957202|142993174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.3807|TWO_SIDED|95.0|-0.175|0.456|||Mixed Model ANOVA|||||0.456|-0.175|0.3807
71740567|NCT00394706|142993193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||0.59|TWO_SIDED|95.0|-1.1|0.7||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|Mixed Models Analysis||Estimate of the rate of MRS \<= 3 in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of MRS \<=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.||0.7|-1.1|0.59
71740568|NCT00394706|142993193|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.71|TWO_SIDED|95.0|-1.1|0.8||To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)|t-test, 2 sided||Estimate of the rate of MRS \<= 3 in the active ITD arm minus the rate in the Sham ITD arm.|Comparison of the rates of MRS \<=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.||0.8|-1.1|0.71
71740569|NCT00394706|142993194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1||||0.92|TWO_SIDED|95.0|-1.2|1.1||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|GEE||Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.||1.1|-1.2|0.92
71740570|NCT00394706|142993194|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.99|TWO_SIDED|95.0|-1.2|1.1|||t-test, 2 sided||Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.|Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.||1.1|-1.2|0.99
71740571|NCT00394706|142993195|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.2|0.34|||||Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.34|-0.20|
71740572|NCT00394706|142993195|SUPERIORITY||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.17|0.44|||||Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.44|-0.17|
71740573|NCT00394706|142993196|SUPERIORITY||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.71|0.83|||||Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.83|-0.71|
71740574|NCT00394706|142993196|SUPERIORITY||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-1.61|0.28|||||Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.28|-1.61|
71740575|NCT00394706|142993197|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.05|||||Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.06|
71740576|NCT00394706|142993197|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.08|0.05|||||Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.||0.05|-0.08|
71740577|NCT03369249|142993198|SUPERIORITY||log ratio of rate ratios|0.15|STANDARD_ERROR_OF_MEAN|0.31||0.635|TWO_SIDED|95.0|-0.46|0.75||A priori threshold for statistical significance was \<0.05|generalized estimating equations||Standard error of the Beta regression coefficient.|||0.75|-0.46|0.635
71661862|NCT04715932|142836912|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8797|TWO_SIDED|95.0|0.27|4.65|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.65|0.27|0.8797
71661863|NCT04715932|142836913|SUPERIORITY||Odds Ratio (OR)|3.71||||0.2634|TWO_SIDED|95.0|0.37|37.03|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||37.03|0.37|0.2634
71661864|NCT04715932|142836914|SUPERIORITY||Odds Ratio (OR)|1.5||||0.271|TWO_SIDED|95.0|0.73|3.06|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.06|0.73|0.2710
71661865|NCT04715932|142836915|SUPERIORITY||Odds Ratio (OR)|1.82||||0.1748|TWO_SIDED|95.0|0.77|4.3|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||4.30|0.77|0.1748
71661866|NCT04715932|142836916|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8513|TWO_SIDED|95.0|0.34|3.63|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||3.63|0.34|0.8513
71661867|NCT04715932|142836917|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7906|TWO_SIDED|95.0|0.29|5.07|||Mixed Models Analysis|Generalized linear mixed model (repeated binary logistic regression)||||5.07|0.29|0.7906
71661868|NCT02740699|142836967|SUPERIORITY|||||||0.0256|||||||Wilcoxon Signed Rank Tests|||||||0.0256
71661869|NCT02740699|142836968|SUPERIORITY|||||||0.0254|||||||Wilcoxon Signed Rank Tests|||||||0.0254
71661870|NCT02740699|142836969|SUPERIORITY|||||||0.58|||||||Regression, Linear|||||||0.58
71661871|NCT02740699|142836970|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71661872|NCT02740699|142836971|SUPERIORITY|||||||0.69|||||||Regression, Linear|||||||0.69
71661873|NCT02740699|142836972|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
71661874|NCT03783039|142836975|NON_INFERIORITY|10% margin|Risk Difference (RD)|0.0605|||<|0.0001|ONE_SIDED|97.5|-0.0189|||Testing whether the group difference in proportion of successes is \>-0.1 (Test Group - Control Group)|Farrington-Manning method||||||-0.0189|<0.0001
71661875|NCT03783039|142836976|OTHER||Difference in proportion of successes|0.0992|||||TWO_SIDED|95.0|0.0078|0.1906|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.1906|0.0078|
71661876|NCT03783039|142836977|OTHER||Difference in proportion of successes|0.0275|||||TWO_SIDED|95.0|-0.0312|0.0863|||Farrington-Manning Method|Difference in proportion of successes (Test Group - Control Group)||||0.0863|-0.0312|
71661877|NCT00918138|142836989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|7.01||0.1278|TWO_SIDED|95.0|-24.8|3.2||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|With at least 36 participants per treatment group (72 total), there is 90% power to detect a difference of 18 mg/dL between the two treatment groups. Assuming approximately 20% of participants will discontinue without any valid post-randomization assessment at Week 4, a total of 90 participants (45 participants per treatment group) needed to be randomized.||3.2|-24.8|0.1278
71661878|NCT00918138|142836990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|STANDARD_ERROR_OF_MEAN|11.8|||TWO_SIDED|95.0|-54.6|-7.7||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg.|||-7.7|-54.6|
71740578|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.86||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Arm A vs Arm B shift test on Angiopoietin -- 2 prior to cycle 2. Wilcoxon rank-sum test p-value.||||0.86
71740579|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.76||||||Angiopoietin -- 2 prior to cycle 3.|Wilcoxon (Mann-Whitney)|||Angiopoietin -- 2 prior to cycle 3||||0.76
71740580|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.14||||||No adjustment for multiple comparison. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie--2 Prior to cycle 2||||0.14
71740581|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||No adjustment for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Tie -- 2 prior to cycle 3||||0.069
71740582|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.19||||||P-value is not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF -- A prior to cycle 2||||0.19
71740583|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||P-value is not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||VEGF--A prior to cycle 3||||0.046
71740584|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.029||||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF Prior to Cycle 2||||0.029
71740585|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.2||||||P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||PIGF prior to cycle 3||||0.20
71661879|NCT00918138|142836991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|7.18|||TWO_SIDED|95.0|-20.0|8.5||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure.|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model.|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|||8.5|-20.0|
71661880|NCT01955837|142836996|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.035|TWO_SIDED|95.0|0.62|0.99|||Log Rank|||||0.99|0.62|0.035
71740586|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance is 0.05|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 2||||0.11
71661881|NCT01955837|142836997|SUPERIORITY||Hazard Ratio (HR)|0.43|||<|0.001|TWO_SIDED|95.0|0.34|0.54|||Log Rank|||||0.54|0.34|<0.001
71740587|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.068||||||P-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VEGFR--3 prior to cycle 3||||0.068
71740588|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 2||||0.61
71740589|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.27||||||Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.|Wilcoxon (Mann-Whitney)|||VEGF--C prior to cycle 3||||0.27
71740590|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.61||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 2||||0.61
71775700|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.341|TWO_SIDED|95.0|-0.5|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.50|0.341
71661882|NCT01955837|142836998|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.37|0.58|||Log Rank|||||0.58|0.37|<0.001
71740591|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.49||||||The p-value was not adjusted for multiple comparisons, and the a-priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||IL--8 prior to cycle 3||||0.49
71740592|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.82||||||The p-value was not adjusted for multiple comparisons. The a-priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 2||||0.82
71740593|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.069||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||ICAM--1 prior to cycle 3||||0.069
71740594|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.34||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 2||||0.34
71740595|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.046||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||VCAM--1 prior to cycle 3||||0.046
71740596|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.11||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 2||||0.11
71740597|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.23||||||The p-value was adjusted for multiple comparisons. The a prior threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||FGF2 prior to cycle 3||||0.23
71740598|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.37||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 2||||0.37
71740599|NCT01664182|142993227|OTHER|Two sided hypothesis. Wilcoxon rank-sum test comparing the two arms in terms of the ratio of the post-treatment levels divided by the baseline.||||||0.35||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was set to 0.05.|Wilcoxon (Mann-Whitney)|||PDGF--AA prior to cycle 3||||0.35
71775701|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.031|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.71|0.031
71661883|NCT01955837|142836999|SUPERIORITY||Difference in ORR|1.1||||0.554|TWO_SIDED|95.0|-0.1|2.4|||Fisher Exact|||||2.4|-0.1|0.554
71661884|NCT01955837|142837000|SUPERIORITY||Difference in DCR|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
71661885|NCT01955837|142837001|SUPERIORITY||Odds Ratio (OR)|29.4|||<|0.001|TWO_SIDED|95.0|20.9|38.0|||Fisher Exact|||||38.0|20.9|<0.001
71661886|NCT01955837|142837004|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.083|TWO_SIDED|95.0|0.57|1.04|||Log Rank|||||1.04|0.57|0.083
71661887|NCT01955837|142837005|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.228|TWO_SIDED|95.0|0.57|1.2|||Log Rank|||||1.20|0.57|0.228
71661888|NCT01955837|142837006|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.32|0.59||||||||0.59|0.32|
71775702|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.17||0.349|TWO_SIDED|95.0|-0.49|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.49|0.349
71775703|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.17||0.78|TWO_SIDED|95.0|-0.29|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.29|0.780
71775704|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.31|<0.001
71775705|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.29|<0.001
71661889|NCT01955837|142837007|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.31|0.65||||||||0.65|0.31|
71661890|NCT00552578|142837008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17||||0.523||95.0|0.0098|2.8215|||Fisher Exact|||Intent to treat||2.8215|0.0098|0.523
71661891|NCT00552578|142837010|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||No adjustment|Fisher Exact|||Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.||||0.015
71661892|NCT02885181|142837019|SUPERIORITY||Least Squares (LS) Means of Differences|0.01||||0.978|TWO_SIDED|95.0||0.76|||Cochran-Mantel-Haenszel|||||0.76|- 0.74|0.978
71740600|NCT02881762|142993239|OTHER|Comparison of mean change analyzed with unpaired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).||||||0.13|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in change in HCV viral load between Maraviroc and No Maraviroc||||0.13
71740601|NCT02881762|142993240|OTHER|Comparison of difference in mean analyzed with paired t-test for parametric data. The test was performed with a significance level of 0.05 (two-sided).|||||>|0.5|||||||t-test, 2 sided|||Null hypothesis is that there is no difference in HCV viral load between baseline and 7 days of maraviroc.||||>0.5
71740602|NCT00632619|142993251|SUPERIORITY_OR_OTHER|||||||0.106|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.106
71740603|NCT00632619|142993252|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline which was week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.015
71740604|NCT00632619|142993253|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was conducted to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.38
71740605|NCT00632619|142993254|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.016
71740606|NCT00632619|142993255|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.||||0.095
71775706|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-0.99|-0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.99|<0.001
71775707|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.88|0.005
71775708|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|95.0|-0.47|0.26|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.26|-0.47|0.562
71775709|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.028|TWO_SIDED|95.0|-0.77|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.77|0.028
71775710|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.19||0.084|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.68|0.084
71775711|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.91|TWO_SIDED|95.0|-0.38|0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.38|0.910
71775712|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.69|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.40|<0.001
71775713|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.27|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.27|<0.001
71775714|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.25|-0.55|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.25|<0.001
71775715|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.003|TWO_SIDED|95.0|-0.88|-0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.88|0.003
71775716|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.039|TWO_SIDED|95.0|-0.72|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.72|0.039
71775717|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.032|TWO_SIDED|95.0|-0.74|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.74|0.032
71775718|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.409|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.50|0.409
71775719|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.461|TWO_SIDED|95.0|-0.49|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.49|0.461
71890803|NCT03293654|143303401|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.16|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.09|1.22|||||MB02 represents the numerator and EU Avastin represents the denominator|||1.22|1.09|
71890804|NCT03293654|143303401|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.07|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.0|1.13|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||1.13|1|
71775720|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.59|<0.001
71775721|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.4|-0.65|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.40|<0.001
71775722|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.17|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.17|<0.001
71775723|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.97|0.002
71775724|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.281|TWO_SIDED|95.0|-0.58|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.58|0.281
71775725|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.023|TWO_SIDED|95.0|-0.81|-0.06|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.81|0.023
71775726|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.19||0.031|TWO_SIDED|95.0|-0.79|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.79|0.031
71775727|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.331|TWO_SIDED|95.0|-0.56|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.56|0.331
71775728|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.47|<0.001
71775729|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.6|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.33|<0.001
71775730|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.03|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.03|<0.001
71890805|NCT03293654|143303408|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.962|1.07|||||MB02 in numerator and EU Avastin in denominator|||1.07|0.962|
71661893|NCT02885181|142837019|SUPERIORITY||LS Means of Differences|0.4||||0.3|TWO_SIDED|95.0||1.16|||Cochran-Mantel-Haenszel|||||1.16|- 0.36|0.300
71661894|NCT02885181|142837019|SUPERIORITY||LS Means of Differences|0.0||||0.002|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||- 0.43|- 1.92|0.002
71661895|NCT02885181|142837020|SUPERIORITY||Difference in Response Rates|-5.9||||0.66|TWO_SIDED|95.0|-36.0|24.0|||Cochran-Mantel-Haenszel|||||24.0|-36.0|0.660
71661896|NCT02885181|142837020|SUPERIORITY||Difference in Response Rates|-15.9||||0.277|TWO_SIDED|95.0|-44.7|13.8|||Cochran-Mantel-Haenszel|||||13.8|-44.7|0.277
71661897|NCT02885181|142837020|SUPERIORITY||Difference in Response Rates|40.0||||0.009|TWO_SIDED|95.0|10.7|65.6|||Cochran-Mantel-Haenszel|||||65.6|10.7|0.009
71661898|NCT02885181|142837021|SUPERIORITY||Difference in Response Rates|-2.7||||0.853|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.853
71661899|NCT02885181|142837021|SUPERIORITY||Difference in Response Rates|-2.7||||0.852|TWO_SIDED|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel|||||27.5|-32.0|0.852
71775731|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.98|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-0.98|<0.001
71775732|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.18||0.781|TWO_SIDED|95.0|-0.41|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.41|0.781
71775733|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.71|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.71|0.057
71775734|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.016|TWO_SIDED|95.0|-0.8|-0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.80|0.016
71775735|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.18||0.45|TWO_SIDED|95.0|-0.5|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.50|0.450
71775736|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.47|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.47|<0.001
71890806|NCT03293654|143303408|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.996|1.13|||||MB02 is numerator and US Avastin is denominator|||1.13|0.996|
71661900|NCT02885181|142837021|SUPERIORITY||Difference in Response Rates|24.9||||0.092|TWO_SIDED|95.0|-6.6|51.5|||Cochran-Mantel-Haenszel|||||51.5|-6.6|0.092
71661901|NCT02885181|142837022|SUPERIORITY||Difference in Response Rates|-8.6||||0.36|TWO_SIDED|95.0|-37.9|22.5|||Cochran-Mantel-Haenszel|||||22.5|-37.9|0.360
71661902|NCT02885181|142837022|SUPERIORITY||Difference in Response Rates|1.4||||0.896|TWO_SIDED|95.0|-28.0|31.7|||Cochran-Mantel-Haenszel|||||31.7|-28.0|0.896
71661903|NCT02885181|142837022|SUPERIORITY||Difference in Response Rates|24.5||||0.072|TWO_SIDED|95.0|-6.6|50.1|||Cochran-Mantel-Haenszel|||||50.1|-6.6|0.072
71661904|NCT02885181|142837023|SUPERIORITY||LS Means of Differences|-0.12||||0.528|TWO_SIDED|95.0|-0.49|0.25|||Cochran-Mantel-Haenszel|||||0.25|-0.49|0.528
71661905|NCT02885181|142837023|SUPERIORITY||LS Means of Differences|0.2||||0.293|TWO_SIDED|95.0|-0.17|0.57|||Cochran-Mantel-Haenszel|||||0.57|-0.17|0.293
71661906|NCT02885181|142837023|SUPERIORITY||LS Means of Differences|-0.33||||0.072|TWO_SIDED|95.0|-0.7|0.03|||Cochran-Mantel-Haenszel|||||0.03|-0.70|0.072
71661907|NCT04228783|142837032|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
71661908|NCT04228783|142837032|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.8|1.1||||||||1.1|0.8|
71775737|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.2|-0.42|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.20|<0.001
71775738|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.12|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.12|<0.001
71775739|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.04|-0.26|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.26|-1.04|0.001
71775740|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.699|TWO_SIDED|95.0|-0.47|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.47|0.699
71775741|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.408|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.408
71775742|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.74|0.077
71661909|NCT04228783|142837032|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.9|1.2||||||||1.2|0.9|
71661910|NCT04228783|142837033|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.2||||||||1.2|0.8|
71661911|NCT04228783|142837033|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
71775743|NCT00809354|143051253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.182|TWO_SIDED|95.0|-0.65|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.65|0.182
71775744|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.16||0.798|TWO_SIDED|95.0|-0.36|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.36|0.798
71775745|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.779|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.37|0.779
71661912|NCT04228783|142837033|EQUIVALENCE|An equivalence margin of 0.5 to 2.0 was considered relevant to demonstrate the equivalence of the two products.|Ratio of GMCs|1.0|||||TWO_SIDED|95.0|0.8|1.3||||||||1.3|0.8|
71661913|NCT00626392|142837038|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Cochran-Mantel-Haenszel|||||||0.010
71661914|NCT03151811|142837048|SUPERIORITY|||||||0.0311|||||||Log Rank|||||||0.0311
71775746|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.057|TWO_SIDED|95.0|-0.64|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.64|0.057
71775747|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.16||0.927|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.31|0.927
71775748|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.98|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.980
71775749|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.16||0.098|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.60|0.098
71775750|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.709|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.26|0.709
71775751|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.045|TWO_SIDED|95.0|0.01|0.65|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.65|0.01|0.045
71775752|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.919|TWO_SIDED|95.0|-0.36|0.33|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.36|0.919
71775753|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.183|TWO_SIDED|95.0|-0.11|0.58|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.58|-0.11|0.183
71775754|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.504|TWO_SIDED|95.0|-0.46|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.46|0.504
71775755|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.71|TWO_SIDED|95.0|-0.28|0.41|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.41|-0.28|0.710
71775756|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|95.0|-0.09|0.59|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.59|-0.09|0.152
71775757|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.572|TWO_SIDED|95.0|-0.44|0.24|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.24|-0.44|0.572
71775758|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.337|TWO_SIDED|95.0|-0.51|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.51|0.337
71775759|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.17||0.299|TWO_SIDED|95.0|-0.16|0.52|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.52|-0.16|0.299
71775760|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.17||0.005|TWO_SIDED|95.0|-0.82|-0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.82|0.005
71775761|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.05|<0.001
71775762|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.25|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.25|<0.001
71661915|NCT01158573|142837136|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Hypothesis that leptin levels in OA is not different from the other 3 groups.|ANOVA|||||||<0.0001
71833867|NCT04714320|143171966|SUPERIORITY||||||=|0.514||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 120||||=0.514
71833868|NCT04714320|143171966|SUPERIORITY||||||=|0.479||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.479
71833869|NCT04714320|143171966|SUPERIORITY||||||=|0.292||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 148||||=0.292
71833870|NCT04714320|143171966|SUPERIORITY||||||=|0.528||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.528
71833871|NCT04714320|143171966|SUPERIORITY||||||=|0.946||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg at Day 169||||=0.946
71833872|NCT04714320|143171966|SUPERIORITY||||||=|0.552||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.552
71833873|NCT04714320|143171966|SUPERIORITY||||||=|0.598||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 8||||=0.598
71890807|NCT03293654|143303408|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.983|1.11|||||EU Avastin in the numerator and US Avastin in the denominator|||1.11|0.983|
71833874|NCT04714320|143171966|SUPERIORITY||||||=|0.184||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.184
71833875|NCT04714320|143171966|SUPERIORITY||||||=|0.614||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 15||||=0.614
71833876|NCT04714320|143171966|SUPERIORITY||||||=|0.933||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.933
71833877|NCT04714320|143171966|SUPERIORITY||||||=|0.803||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 22||||=0.803
71890808|NCT03293654|143303409|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.02|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.969|1.07|||||MB02: EU Avastin|||1.07|0.969|
71661916|NCT01158573|142837137|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.002
71890809|NCT03293654|143303409|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.06|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.998|1.12|||||MB02: US Avastin|||1.12|0.998|
71833878|NCT04714320|143171966|SUPERIORITY||||||=|0.686||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.686
71833879|NCT04714320|143171966|SUPERIORITY||||||=|0.752||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 29||||=0.752
71833880|NCT04714320|143171966|SUPERIORITY||||||=|0.106||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.106
71661917|NCT01158573|142837138|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANOVA|||||||0.725
71661918|NCT01158573|142837139|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANOVA|||||||0.16
71740607|NCT01635855|142993271|SUPERIORITY_OR_OTHER||One-sided binomial|8.5|||<|0.025|TWO_SIDED|95.0|3.5|13.6||Ho (null): Ps \>= 22% versus Ha (alternate): Ps \< 22% where Ps is the proportion of subjects with common severe adverse events in the post-approval study. Ho is rejected if upper limit of the 95% CI of Ps \< 22% and the one-sided p-value \<= 0.025.|One sided binomial distribution|The upper limit of the 95% two-sided CI for a proportion is equivalent to the 97.5% one-sided CI for that proportion for normal approximations.||The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.||13.6|3.5|< 0.025
71740608|NCT03828019|142993272|SUPERIORITY||Odds Ratio (OR)|1.86||||0.029|TWO_SIDED|95.0|1.06|3.25|||Regression, Logistic|Adjusted for the 2 stratification variables (initial prednisone dose and immunosuppression use at baseline).|Estimated parameter is the Odds Ratios (ADA/CID). Result greater than 1 indicates ADA is superior in achieving successful corticosteroid sparing|The sample size estimation: Adalimumab was estimated to be successful in 75% of patients. The overall success rate with conventional immunosuppression was estimated to be 51%. A sample size of 222 (111 per treatment group) provided 90% power to detect a difference in cumulative percent of 75% versus 51%||3.25|1.06|0.029
71740609|NCT03828019|142993273|SUPERIORITY||Odds Ratio (OR)|1.91||||0.072|TWO_SIDED|95.0|0.94|3.86|||Regression, Logistic||Odds ADA/ Odds CID|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.86|0.94|0.072
71740610|NCT03828019|142993274|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3|TWO_SIDED|95.0|0.67|3.46|||Regression, Logistic||Odds ratio is ADA/CID where value greater than 1 indicates ADA is superior for corticosteroid (prednisone) discontinuation|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.46|0.67|0.30
71740611|NCT03828019|142993275|SUPERIORITY||Odds Ratio (OR)|1.85||||0.028|TWO_SIDED|95.0|1.06|3.19|||Regression, Logistic||Odds ADA/ Odds CID where value greater than 1 indicate greater corticosteroid sparing success in the ADA group|Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. 2 stratification variables (initial prednisone dose and immunosuppression use at baseline) were included||3.19|1.06|0.028
71740612|NCT03828019|142993276|SUPERIORITY||Ratio of rate of steroid (mg/day ADA/CID|0.86||||0.061|TWO_SIDED|95.0|0.73|1.01|||negative binomial model||Number greater than 1 would indicate rate of steroid use is higher in participants assigned to ADA|||1.01|0.73|0.061
71890810|NCT03293654|143303409|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.981|1.1|||||EU Avastin: US Avastin|||1.1|0.981|
71890811|NCT03293654|143303410|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|0.986|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|0.903|1.08|||||MB02: EU Avastin|||1.08|0.903|
71740613|NCT03828019|142993277|SUPERIORITY||Difference in mean change from BL|0.4||||0.77|TWO_SIDED|95.0|-2.3|3.1|||Mixed Models Analysis|||Mixed effects models were used with a linear link. The fixed effects included initial steroid dose and immunosuppression use at baseline. Additional visit indicators (months 1-12) and corresponding treatment by visit interaction terms. An unstructured correlation was used to model repeated measurements by eye . A person-level random intercept was added to account for between-eye correlations.||3.1|-2.3|0.77
71740614|NCT03828019|142993278|SUPERIORITY||Ratio of odds ratios|0.55||||0.028|TWO_SIDED|95.0|0.31|0.94|||Regression, Logistic||estimate is the ratio of odds ratios - OR ADA / OR CID. Value less than 1 indicates ADA is better at reducing macular edema.|Mixed effects models with a log link were used to assess treatment differences . The outcome measure was the odds ratio of having macular edema (OCT central subfield thickness \> 300 um) at 12 months compared to baseline (BL). The treatment effect was the ratio of Odds ratios (ADA/CID) at 12 months. Values less than one indicate improvement in macular edema for the ADA treatment group relative to the CID group. Decrease in subfield thickness is good||0.94|0.31|0.028
71740615|NCT03828019|142993279|SUPERIORITY||Risk Ratio (RR)|1.1||||0.76|TWO_SIDED|95.0|0.61|1.98|||negative binomial model|||||1.98|0.61|0.76
71740616|NCT03828019|142993280|SUPERIORITY||Cox Proportional Hazard|0.16||||0.014|TWO_SIDED|95.0|0.04|0.7|||Regression, Cox|||. Kaplan Meier techniques and Cox proportional hazards models were used to evaluate time to event outcomes||0.70|0.04|0.014
71740617|NCT03828019|142993281|SUPERIORITY||Cox Proportional Hazard|0.89||||0.74|TWO_SIDED|95.0|0.43|1.82|||Regression, Cox|||||1.82|0.43|0.74
71740618|NCT03828019|142993282|SUPERIORITY||Odds Ratio (OR)|0.76||||0.35|TWO_SIDED|95.0|0.43|1.34|||Ratio of odds ratios||Treatment comparison is the ratio of the odds ratios for each treatment group (ADA/CID) at 12 months. Values greater than one indicate greater improvement in health for the ADA treatment group relative to the CID group.|||1.34|0.43|0.35
71740619|NCT03828019|142993283|SUPERIORITY||Mean Difference (Net)|1.39||||0.24|TWO_SIDED|95.0|-0.95|3.73|||Mixed Models Analysis|||||3.73|-0.95|0.24
71740620|NCT03828019|142993284|SUPERIORITY||Mean Difference (Net)|0.59||||0.7|TWO_SIDED|95.0|-2.43|3.61|||Mixed Models Analysis|||||3.61|-2.43|0.70
71740621|NCT03828019|142993285|SUPERIORITY||Mean Difference (Net)|1.6||||0.28|TWO_SIDED|95.0|-1.4|4.6|||Mixed Models Analysis|||||4.6|-1.4|0.28
71740622|NCT03828019|142993286|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.009|TWO_SIDED|95.0|0.07|0.67|||Regression, Cox|||||0.67|0.07|0.009
71775763|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.23|-0.56|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.23|<0.001
71775764|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.177|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.177
71775765|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.76|0.014
71775766|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.286|TWO_SIDED|95.0|-0.52|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.52|0.286
71775767|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.952|TWO_SIDED|95.0|-0.33|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.33|0.952
71775768|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.21|-0.95|0.002
71775769|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-0.94|-0.2|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.94|0.003
71775770|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.26|-0.52|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.52|-1.26|<0.001
71775771|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.55|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.55|-1.29|<0.001
71775772|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.972|TWO_SIDED|95.0|-0.36|0.38|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.38|-0.36|0.972
71775773|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.096|TWO_SIDED|95.0|-0.69|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.69|0.096
71775774|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.19||0.069|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.72|0.069
71775775|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.19||0.902|TWO_SIDED|95.0|-0.39|0.35|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.39|0.902
71775776|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.93|-0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.22|-0.93|0.002
71775777|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.33|-0.61|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.61|-1.33|<0.001
71775778|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.38|-0.66|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.66|-1.38|<0.001
71775779|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.84|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.84|-1.55|<0.001
71775780|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.028|TWO_SIDED|95.0|-0.75|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.75|0.028
71775781|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.013|TWO_SIDED|95.0|-0.81|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.81|0.013
71775782|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.217|TWO_SIDED|95.0|-0.58|0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.58|0.217
71775783|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.18||0.351|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.53|0.351
71775784|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.28|-1.05|<0.001
71775785|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.22|-0.45|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.45|-1.22|<0.001
71775786|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.38|-0.62|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.62|-1.38|<0.001
71740623|NCT03401671|142993315|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.0229|||||TWO_SIDED|90.0|0.8473|1.2349||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.2349|0.8473|
71740624|NCT03401671|142993317|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9324|||||TWO_SIDED|90.0|0.8016|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8016|
71740625|NCT03401671|142993318|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9318|||||TWO_SIDED|90.0|0.8005|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.||1.0846|0.8005|
71740626|NCT04090242|142993335|OTHER||Mean Difference (Final Values)|-0.16||||0.392|TWO_SIDED|95.0|-0.53|0.21||The p value is for the comparison between interventional and control group on change of DES score between baseline and end of study.|Mixed Models Analysis|||With assumptions made in statistical analysis plan, a sample size of 43 subjects per arm had \>80% power to detect a significant difference between the two arms (based on a 2-sided t-test, 95% CI for DES difference between groups). Adding a 10% buffer, planned enrollment was 96 subjects. However, enrollment ended early with about 25 subjects in each arm (56 subjects total). Thus, power decreased to 56%. The study was not sufficiently powered under these conditions.||0.21|-0.53|0.392
71740627|NCT01898013|142993352|SUPERIORITY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.25||0.02|TWO_SIDED|||||a priori threshold set at 0.05|Mixed Models Analysis|||||||0.02
71740628|NCT01898013|142993353|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.14||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
71740629|NCT01898013|142993354|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.12||0.79|TWO_SIDED||||||Mixed Models Analysis|||||||0.79
71775787|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.57|-0.8|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.80|-1.57|<0.001
71775788|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.389|TWO_SIDED|95.0|-0.55|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.55|0.389
71775789|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.087|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.72|0.087
71775790|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.072|TWO_SIDED|95.0|-0.74|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.74|0.072
71775791|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.34|TWO_SIDED|95.0|-0.57|0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.20|-0.57|0.340
71775792|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
71775793|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.11|-0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.39|-1.11|<0.001
71775794|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.42|-0.69|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.69|-1.42|<0.001
71775795|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.87|-1.59|<0.001
71775796|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.762|TWO_SIDED|95.0|-0.42|0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.42|0.762
71775797|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.19||0.056|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.056
71775798|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.01|TWO_SIDED|95.0|-0.84|-0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.84|0.010
71740630|NCT01898013|142993355|SUPERIORITY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
71740631|NCT01898013|142993356|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||Mixed Models Analysis|||||||0.63
71740632|NCT01898013|142993357|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.13||0.62|TWO_SIDED||||||Mixed Models Analysis|||||||0.62
71740633|NCT03182907|142993362|OTHER|The AUC0-inf of bezlotoxumab in Cohort 1 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|Geometric Mean Ratio (GMR)|1.06|||||TWO_SIDED|90.0|0.95|1.18|||||GMR was calculated as the Cohort 1 geometric mean (GM) AUC0-inf / Adult GM AUC0-inf.|||1.18|0.95|
71775799|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.19||0.335|TWO_SIDED|95.0|-0.54|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.54|0.335
71740634|NCT03182907|142993362|OTHER|The AUC0-inf of bezlotoxumab in Cohort 2 was compared to the AUC0-inf of bezlotoxumab in adults using an analysis of variance (ANOVA) model. The comparison adult PK dataset used was based on participants from 2 adult trials (NCT01241552 and NCT01513239) as a historical control.|GMR|0.82|||||TWO_SIDED|90.0|0.75|0.89|||||GMR was calculated as the Cohort 2 GM AUC0-inf / Adult GM AUC0-inf.|||0.89|0.75|
71740635|NCT03182907|142993363|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% confidence intervals (CIs) in bezlotoxumab versus placebo arms.|Difference in percentage|-5.7|||||TWO_SIDED|95.0|-14.5|7.7||||||||7.7|-14.5|
71740636|NCT03182907|142993364|OTHER|Miettinen \& Nurminen method was used to generate the estimated difference in percentage and associated 95% CIs in bezlotoxumab versus placebo arms.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.7|3.5||||||||3.5|-9.7|
71740637|NCT03182907|142993365|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|-3.7|||=|0.5701|TWO_SIDED|95.0|-20.0|8.0|||Stratified Miettinen and Nurminen method|||||8.0|-20.0|= 0.5701
71740638|NCT03182907|142993366|OTHER|Miettinen and Nurminen method stratified by age cohort (12 to \<18 years of age, 1 to \<12 years of age) with a Cochran-Mantel-Haenszel weight was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.8|||=|0.9165|TWO_SIDED|95.0|-11.8|17.6|||Stratified Miettinen and Nurminen method|||||17.6|-11.8|= 0.9165
71740639|NCT03182907|142993367|OTHER|Unstratified Miettinen and Nurminen method was used to generate the treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted Difference|-3.1|||=|0.6542|TWO_SIDED|95.0|-19.9|9.0|||Unstratified Miettinen & Nurminen method|||||9.0|-19.9|= 0.6542
71740640|NCT03182907|142993368|OTHER|Unstratified Miettinen and Nurminen method was used to generate treatment difference, associated 95% CIs and a 2-sided p-value.|Adjusted difference|0.1|||=|0.9873|TWO_SIDED|95.0|-13.0|17.4|||Unstratified Miettinen & Nurminen method|||||17.4|-13.0|= 0.9873
71740641|NCT00429169|142993372|SUPERIORITY_OR_OTHER||regression coefficient|-0.29||||0.03|TWO_SIDED|95.0|-0.57|-0.023||The p-value applies to the interaction term of Treatment X Baseline Suicidal Ideation severity.|Mixed Models Analysis|||Generalized least squares model of Scale for Suicidal Ideation score during 8-week acute treatment of major depressive disorder.||-0.023|-0.57|0.03
71740642|NCT02815644|142993393|SUPERIORITY_OR_OTHER||T/R ratio|55.69|STANDARD_ERROR_OF_MEAN|1.087|||TWO_SIDED|90.0|48.22|64.33|||||Standard Error of the mean is actually geometric Standard Error of the mean.|"Relative bioavailability of linagliptin after food intake compared to while in the fasting state was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||64.33|48.22|
71740643|NCT02815644|142993394|SUPERIORITY_OR_OTHER||T/R ratio|74.89|STANDARD_ERROR_OF_MEAN|1.073|||TWO_SIDED|90.0|66.27|84.64|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||84.64|66.27|
71740644|NCT02815644|142993395|SUPERIORITY_OR_OTHER||T/R ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
71740645|NCT02815644|142993396|SUPERIORITY_OR_OTHER||T/R ratio|85.99|STANDARD_ERROR_OF_MEAN|1.018|||TWO_SIDED|90.0|83.38|88.68|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||88.68|83.38|
71775800|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.38|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.38|-1.18|<0.001
71775801|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.24|-0.44|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.24|<0.001
71740646|NCT02815644|142993397|SUPERIORITY_OR_OTHER||T/R ratio|88.13|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|90.0|80.89|96.03|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||96.03|80.89|
71740647|NCT02815644|142993398|SUPERIORITY_OR_OTHER||T/R ratio|86.33|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|83.61|89.13|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||89.13|83.61|
71775802|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.25|-0.46|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.46|-1.25|<0.001
71740648|NCT02815644|142993399|SUPERIORITY_OR_OTHER||T/R Ratio|82.19|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|"Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: sequence, subjects within sequences, period, and treatment (i.e., feeding status). The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed."||86.18|78.38|
71775803|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.52|-0.73|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.52|<0.001
71740649|NCT03364309|142993405|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.0001|TWO_SIDED|95.0|33.57|99.99|||Regression, Logistic|||||99.99|33.57|<0.0001
71740650|NCT03364309|142993405|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|52.49|99.99|||Regression, Logistic|||||99.99|52.49|<0.001
71740651|NCT03364309|142993406|SUPERIORITY||Odds Ratio (OR)|79.95|||<|0.001|TWO_SIDED|95.0|32.76|99.99|||Regression, Logistic|||||99.99|32.76|<0.001
71740652|NCT03364309|142993406|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|64.87|99.99|||Regression, Logistic|||||99.99|64.87|<0.001
71740653|NCT03364309|142993408|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|31.88|99.99|||Regression, Logistic|||||99.99|31.88|<0.001
71775804|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.782|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.34|-0.46|0.782
71775805|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.719|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.47|0.719
71775806|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.158|TWO_SIDED|95.0|-0.69|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.69|0.158
71775807|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.67|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.67|0.183
71775808|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.004|TWO_SIDED|95.0|-0.9|-0.18|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.90|0.004
71775809|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.33|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.05|<0.001
71740654|NCT03364309|142993408|SUPERIORITY||Odds Ratio (OR)|99.99|||<|0.001|TWO_SIDED|95.0|46.96|99.99|||Regression, Logistic|||||99.99|46.96|<0.001
71890812|NCT03293654|143303410|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.1|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.01|1.19|||||MB02: US Avastin|||1.19|1.01|
71740655|NCT03364309|142993410|SUPERIORITY||Odds Ratio (OR)|37.24|||<|0.001|TWO_SIDED|95.0|13.68|99.99|||Regression, Logistic|||||99.99|13.68|<0.001
71740656|NCT03364309|142993410|SUPERIORITY||Odds Ratio (OR)|41.38|||<|0.001|TWO_SIDED|95.0|15.09|99.99|||Regression, Logistic|||||99.99|15.09|<0.001
71740657|NCT03364309|142993411|SUPERIORITY||LSMean Difference|-9.52|STANDARD_ERROR_OF_MEAN|0.604|<|0.001|TWO_SIDED|95.0|-10.71|-8.33|||Mixed Models Analysis|||||-8.33|-10.71|<0.001
71740658|NCT03364309|142993411|SUPERIORITY||LSMean Difference|-9.78|STANDARD_ERROR_OF_MEAN|0.603|<|0.001|TWO_SIDED|95.0|-10.96|-8.59|||Mixed Models Analysis|||||-8.59|-10.96|<0.001
71740659|NCT03364309|142993412|SUPERIORITY||LSMean Difference|-10.09|STANDARD_ERROR_OF_MEAN|1.673|<|0.001|TWO_SIDED|95.0|-13.38|-6.79|||Mixed Models Analysis|||||-6.79|-13.38|<0.001
71775810|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.2|0.48|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.48|-1.20|<0.001
71740660|NCT03364309|142993412|SUPERIORITY||LSMean Difference|-8.81|STANDARD_ERROR_OF_MEAN|1.677|<|0.001|TWO_SIDED|95.0|-12.11|-5.51|||Mixed Models Analysis|||||-5.51|-12.11|<0.001
71740661|NCT03364309|142993413|SUPERIORITY||LSMean Difference|-34.96|STANDARD_ERROR_OF_MEAN|2.023|<|0.001|TWO_SIDED|95.0|-38.94|-30.98|||Mixed Models Analysis|||||-30.98|-38.94|<0.001
71740662|NCT03364309|142993413|SUPERIORITY||LSMean Difference|-36.34|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-40.3|-32.37|||Mixed Models Analysis|||||-32.37|-40.30|<0.001
71740663|NCT03364309|142993414|SUPERIORITY||LSMean Difference|-16.74|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-18.62|-14.86|||Mixed Models Analysis|||||-14.86|-18.62|<0.001
71740664|NCT03364309|142993414|SUPERIORITY||LSMean Difference|-17.93|STANDARD_ERROR_OF_MEAN|0.954|<|0.001|TWO_SIDED|95.0|-19.8|-16.05|||Mixed Models Analysis|||||-16.05|-19.80|<0.001
71740665|NCT03364309|142993415|SUPERIORITY||LSMean Difference|6.228|STANDARD_ERROR_OF_MEAN|0.6681|<|0.001|TWO_SIDED|95.0|4.915|7.541|||Mixed Models Analysis|||||7.541|4.915|<0.001
71740666|NCT03364309|142993415|SUPERIORITY||LSMean Difference|6.536|STANDARD_ERROR_OF_MEAN|0.6668|<|0.001|TWO_SIDED|95.0|5.225|7.847|||Mixed Models Analysis|||||7.847|5.225|<0.001
71740667|NCT03364309|142993416|SUPERIORITY||LSMean Difference|5.193|STANDARD_ERROR_OF_MEAN|0.9489|<|0.001|TWO_SIDED|95.0|3.328|7.058|||Mixed Models Analysis|||||7.058|3.328|<0.001
71740668|NCT03364309|142993416|SUPERIORITY||LSMean Difference|5.362|STANDARD_ERROR_OF_MEAN|0.946|<|0.001|TWO_SIDED|95.0|3.503|7.222|||Mixed Models Analysis|||||7.222|3.503|<0.001
71775811|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.48|-0.76|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.76|-1.48|<0.001
71775812|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.408|TWO_SIDED|95.0|-0.51|0.21|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.21|-0.51|0.408
71775813|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.097|TWO_SIDED|95.0|-0.67|0.06|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.67|0.097
71661919|NCT00073021|142837186|SUPERIORITY_OR_OTHER||Difference in Success Rates|12.543||||0.0357|TWO_SIDED|95.0|0.96|24.12|||Chi-squared|||It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.||24.12|0.96|0.0357
71740669|NCT03364309|142993417|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.4|||Mixed Models Analysis|||||-2.4|-2.9|<0.001
71740670|NCT03364309|142993417|SUPERIORITY||LSMean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-2.9|-2.3|||Mixed Models Analysis|||||-2.3|-2.9|<0.001
71740671|NCT03364309|142993418|SUPERIORITY||LSMean Difference|-3.35|STANDARD_ERROR_OF_MEAN|1.11||0.003|TWO_SIDED|95.0|-5.56|-1.15|||Mixed Models Analysis|||||-1.15|-5.56|0.003
71740672|NCT03364309|142993418|SUPERIORITY||LSMean Difference|-4.79|STANDARD_ERROR_OF_MEAN|1.064|<|0.001|TWO_SIDED|95.0|-6.9|-2.67|||Mixed Models Analysis|||||-2.67|-6.90|<0.001
71740673|NCT03364309|142993419|SUPERIORITY||LSMean Difference|-27.4|STANDARD_ERROR_OF_MEAN|11.07||0.022|TWO_SIDED|95.0|-50.5|-4.3|||Mixed Models Analysis|||||-4.3|-50.5|0.022
71775814|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.018|TWO_SIDED|95.0|-0.79|-0.07|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.79|0.018
71775815|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.132|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.64|0.132
71661920|NCT00073021|142837187|SUPERIORITY_OR_OTHER||Difference Between Means|-0.5||||0.1594|TWO_SIDED|95.0|-1.28|0.21|||ANOVA|||||0.21|-1.28|0.1594
71740674|NCT03364309|142993419|SUPERIORITY||LSMean Difference|-25.2|STANDARD_ERROR_OF_MEAN|10.87||0.031|TWO_SIDED|95.0|-47.8|-2.5|||Mixed Models Analysis|||||-2.5|-47.8|0.031
71740675|NCT03304873|142993421|SUPERIORITY|||||||0.0004|||||||t-test, 1 sided|||||||0.0004
71661921|NCT00073021|142837187|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|The 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
71740676|NCT03304873|142993422|SUPERIORITY|||||||0.99|||||||t-test, 1 sided|||||||0.99
71740677|NCT01052077|142993433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and study center as main effects and Week 8 value as convariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
71740678|NCT01052077|142993434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.3778|TWO_SIDED|95.0|-0.69|0.26||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.26|-0.69|0.3778
71740679|NCT01052077|142993435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31||||0.0162|TWO_SIDED|95.0|-2.38|-0.24||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||-0.24|-2.38|0.0162
71740680|NCT01052077|142993435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0031|TWO_SIDED|95.0|-3.15|-0.65||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||-0.65|-3.15|0.0031
71740681|NCT01052077|142993435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||0.0061|TWO_SIDED|95.0|-3.44|-0.58||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.58|-3.44|0.0061
71775816|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.08|-0.26|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.26|-1.08|0.001
71775817|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.21||0.002|TWO_SIDED|95.0|-1.07|-0.25|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.25|-1.07|0.002
71775818|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.37|-1.19|<0.001
71740682|NCT01052077|142993435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.0038|TWO_SIDED|95.0|-3.69|-0.72||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.72|-3.69|0.0038
71740683|NCT01052077|142993435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.0174|TWO_SIDED|95.0|-3.32|-0.32||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||-0.32|-3.32|0.0174
71740684|NCT01052077|142993435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18||||0.1416|TWO_SIDED|95.0|-2.75|0.39||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.39|-2.75|0.1416
71740685|NCT01052077|142993436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1481|TWO_SIDED|95.0|-0.21|0.03||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||0.03|-0.21|0.1481
71661922|NCT00073021|142837187|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|Teh 2-sample t-test will be used to examine the treatment effect.||||||<0.0001
71740686|NCT01052077|142993436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0691|TWO_SIDED|95.0|-0.28|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||0.01|-0.28|0.0691
71740687|NCT01052077|142993436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.0457|TWO_SIDED|95.0|-0.35|0.0||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||-0.00|-0.35|0.0457
71740688|NCT01052077|142993436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0061|TWO_SIDED|95.0|-0.45|-0.08||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||-0.08|-0.45|0.0061
71775819|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.37|-0.55|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||-0.55|-1.37|<0.001
71775820|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.959|TWO_SIDED|95.0|-0.4|0.42|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.42|-0.40|0.959
71775821|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.618|TWO_SIDED|95.0|-0.51|0.31|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.31|-0.51|0.618
71661923|NCT00073021|142837188|SUPERIORITY_OR_OTHER||Difference in Success Rates|3.75||||0.5774|TWO_SIDED|95.0|-9.43|16.93|||Chi-squared|||||16.93|-9.43|0.5774
71740689|NCT01052077|142993436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0572|TWO_SIDED|95.0|-0.38|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||0.01|-0.38|0.0572
71740690|NCT01052077|142993436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3318|TWO_SIDED|95.0|-0.29|0.1||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.10|-0.29|0.3318
71740691|NCT01052077|142993437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.6272|TWO_SIDED|95.0|-1.02|1.69||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 9||1.69|-1.02|0.6272
71775822|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.149|TWO_SIDED|95.0|-0.71|0.11|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.11|-0.71|0.149
71775823|NCT00809354|143051254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.37|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates||0.22|-0.60|0.370
71775824|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
71775825|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
71661924|NCT00073021|142837189|SUPERIORITY_OR_OTHER||Difference in Success Rates|6.19||||0.2991|TWO_SIDED|95.0|-5.47|17.86|||Chi-squared|||||17.86|-5.47|0.2991
71740692|NCT01052077|142993437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9697|TWO_SIDED|95.0|-1.48|1.54||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo||Week 10||1.54|-1.48|0.9697
71740693|NCT01052077|142993437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.749|TWO_SIDED|95.0|-2.0|1.44||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||1.44|-2.00|0.7490
71740694|NCT01052077|142993437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9459|TWO_SIDED|95.0|-1.94|1.81||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||1.81|-1.94|0.9459
71740695|NCT01052077|142993437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9893|TWO_SIDED|95.0|-1.91|1.88||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||1.88|-1.91|0.9893
71661925|NCT00073021|142837190|SUPERIORITY_OR_OTHER||Difference in Success Rates|2.74||||0.6543|TWO_SIDED|95.0|-9.25|14.73|||Chi-squared|||||14.73|-9.25|0.6543
71661926|NCT00073021|142837191|SUPERIORITY_OR_OTHER||Difference in Success Rates|1.05||||0.8542|TWO_SIDED|95.0|-10.19|12.29|||Chi-squared|||||12.29|-10.19|0.8542
71661927|NCT00073021|142837192|SUPERIORITY_OR_OTHER||Difference in Success Rates|-0.96||||0.8859|TWO_SIDED|95.0|-14.09|12.17|||Chi-squared|||||12.17|-14.09|0.8859
71661928|NCT00073021|142837193|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.73||||0.0758|TWO_SIDED|95.0|-0.94|20.4|||Chi-squared|||||20.40|-0.94|0.0758
71661929|NCT00073021|142837194|SUPERIORITY_OR_OTHER|||||||0.8308||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8308
71661930|NCT00073021|142837194|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
71661931|NCT00073021|142837194|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline.|t-test, 2 sided|||||||<0.0001
71661932|NCT00073021|142837195|SUPERIORITY_OR_OTHER|||||||0.534||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5340
71661933|NCT00073021|142837195|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
71661934|NCT00073021|142837195|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Compared to baseline|t-test, 2 sided|||||||<0.0001
71661935|NCT00073021|142837196|SUPERIORITY_OR_OTHER||Difference in Success Rates|11.1||||0.0966|TWO_SIDED|95.0|-1.87|24.14|||Chi-squared|||||24.14|-1.87|0.0966
71661936|NCT00073021|142837197|SUPERIORITY_OR_OTHER||Difference in Success Rates|9.75||||0.1173|TWO_SIDED|95.0|-2.39|21.89|||Chi-squared|||||21.89|-2.39|0.1173
71661937|NCT00372411|142837252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.08|TWO_SIDED|95.0|-0.23|4.58||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||4.58|-0.23|0.08
71661938|NCT00372411|142837252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.02|TWO_SIDED|95.0|0.57|5.18||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||5.18|0.57|0.02
71661939|NCT00372411|142837252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.92|TWO_SIDED|95.0|-2.94|2.65||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||2.65|-2.94|0.92
71775826|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
71775827|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
71775828|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
71775829|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
71775830|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
71775831|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.17||0.371|TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.49|-0.18|0.371
71775832|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.647|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.40|0.647
71661940|NCT00372411|142837252|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.58||||0.63|TWO_SIDED|95.0|-2.97|1.81||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||1.81|-2.97|0.63
71661941|NCT00372411|142837253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64||||0.009|TWO_SIDED|95.0|2.03|13.24||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||13.24|2.03|0.009
71661942|NCT00372411|142837253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.95||||0.04|TWO_SIDED|95.0|0.34|11.56||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||11.56|0.34|0.04
71775833|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.073|TWO_SIDED|95.0|-0.62|0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.62|0.073
71661943|NCT00372411|142837253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.81|TWO_SIDED|95.0|-3.87|4.94||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.94|-3.87|0.81
71661944|NCT00372411|142837253|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19||||0.55|TWO_SIDED|95.0|-2.74|5.12||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||5.12|-2.74|0.55
71661945|NCT00372411|142837254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41||||0.22|TWO_SIDED|95.0|-11.52|2.7||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||2.70|-11.52|0.22
71661946|NCT00372411|142837254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1||||0.005|TWO_SIDED|95.0|-13.61|-2.6||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||-2.60|-13.61|0.005
71661947|NCT00372411|142837254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.93||||0.82|TWO_SIDED|95.0|-7.03|8.89||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||8.89|-7.03|0.82
71661948|NCT00372411|142837254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.13||||0.55|TWO_SIDED|95.0|-9.2|4.93||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||4.93|-9.20|0.55
71661949|NCT00372411|142837255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.08|TWO_SIDED|95.0|-1.73|0.11||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.11|-1.73|0.08
71661950|NCT00372411|142837255|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.03|TWO_SIDED|95.0|-1.62|-0.06||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||-0.06|-1.62|0.03
71661951|NCT00372411|142837256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.25|0.26||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.||0.26|-0.25|0.95
71775834|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.55|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.55|0.161
71775835|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.961|TWO_SIDED|95.0|-0.33|0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.33|0.961
71740696|NCT01052077|142993437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.8918|TWO_SIDED|95.0|-1.89|2.17||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.17|-1.89|0.8918
71740697|NCT01052077|142993438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.3247|TWO_SIDED|95.0|-1.71|0.57||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||0.57|-1.71|0.3247
71740698|NCT01052077|142993439|SUPERIORITY_OR_OTHER|||||||0.5616||||||Cohran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean: brexpiprazole - placebo.||Week 9||||0.5616
71740699|NCT01052077|142993439|SUPERIORITY_OR_OTHER|||||||0.19||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 10||||0.1900
71740700|NCT01052077|142993439|SUPERIORITY_OR_OTHER|||||||0.0501||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 11||||0.0501
71661952|NCT00372411|142837256|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.1|TWO_SIDED|95.0|-0.42|0.04||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.||0.04|-0.42|0.10
71661953|NCT00631657|142837257|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|48.7|||<|0.0001|TWO_SIDED|95.0|35.0|62.5|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.|||62.5|35.0|<0.0001
71740701|NCT01052077|142993439|SUPERIORITY_OR_OTHER|||||||0.0137||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 12||||0.0137
71740702|NCT01052077|142993439|SUPERIORITY_OR_OTHER|||||||0.0711||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 13||||0.0711
71740703|NCT01052077|142993439|SUPERIORITY_OR_OTHER|||||||0.3438||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||||0.3438
71740704|NCT01052077|142993440|SUPERIORITY_OR_OTHER||Ratio of Response rate|2.79||||0.0679|TWO_SIDED|95.0|0.88|8.81|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||8.81|0.88|0.0679
71740705|NCT01052077|142993440|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.78||||0.036|TWO_SIDED|95.0|1.01|3.14|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||3.14|1.01|0.0360
71740706|NCT01052077|142993440|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.53||||0.0521|TWO_SIDED|95.0|0.99|2.35|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.35|0.99|0.0521
71740707|NCT01052077|142993440|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.93||||0.0008|TWO_SIDED|95.0|1.31|2.86|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||2.86|1.31|0.0008
71740708|NCT01052077|142993440|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.64||||0.0074|TWO_SIDED|95.0|1.14|2.38|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.38|1.14|0.0074
71740709|NCT01052077|142993440|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.47||||0.0339|TWO_SIDED|95.0|1.03|2.08|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 14||2.08|1.03|0.0339
71740710|NCT01052077|142993441|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.27||||0.2404|TWO_SIDED|95.0|0.55|9.3|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9||9.30|0.55|0.2404
71740711|NCT01052077|142993441|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.04||||0.0983|TWO_SIDED|95.0|0.83|4.98|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10||4.98|0.83|0.0983
71740712|NCT01052077|142993441|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.67||||0.0496|TWO_SIDED|95.0|0.99|2.82|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11||2.82|0.99|0.0496
71740713|NCT01052077|142993441|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|2.12||||0.0019|TWO_SIDED|95.0|1.31|3.46|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12||3.46|1.31|0.0019
71740714|NCT01052077|142993441|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.77||||0.0068|TWO_SIDED|95.0|1.17|2.67|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13||2.67|1.17|0.0068
71740715|NCT01052077|142993441|SUPERIORITY_OR_OTHER||Ratio of Remission Rate|1.71||||0.0089|TWO_SIDED|95.0|1.14|2.57||The CMH general association test controlling for trial center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||2.57|1.14|0.0089
71661954|NCT00631657|142837260|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.9||||0.2145|TWO_SIDED|95.0|-12.6|2.8|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.|||2.8|-12.6|0.2145
71740716|NCT01052077|142993442|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.23||||0.4605|TWO_SIDED|95.0|0.7|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 9||2.18|0.70|0.4605
71775836|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.18||0.697|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.42|0.697
71775837|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.139|TWO_SIDED|95.0|-0.62|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.62|0.139
71740717|NCT01052077|142993442|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.2||||0.3267|TWO_SIDED|95.0|0.83|1.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 10||1.72|0.83|0.3267
71740718|NCT01052077|142993442|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.37||||0.023|TWO_SIDED|95.0|1.05|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 11||1.80|1.05|0.0230
71740719|NCT01052077|142993442|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.36||||0.0105|TWO_SIDED|95.0|1.08|1.71|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 12||1.71|1.08|0.0105
71740720|NCT01052077|142993442|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.26||||0.0417|TWO_SIDED|95.0|1.01|1.58|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 13||1.58|1.01|0.0417
71740721|NCT01052077|142993442|SUPERIORITY_OR_OTHER||Ratio of Response Rate|1.15||||0.2345|TWO_SIDED|95.0|0.91|1.44||CMH general association test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole - placebo.||Week 14||1.44|0.91|0.2345
71775838|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.12|TWO_SIDED|95.0|-0.64|0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.64|0.120
71775839|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.637|TWO_SIDED|95.0|-0.44|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.44|0.637
71775840|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.17||0.028|TWO_SIDED|95.0|-0.72|-0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.72|0.028
71775841|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.17||0.024|TWO_SIDED|95.0|-0.74|-0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.74|0.024
71833881|NCT04714320|143171966|SUPERIORITY||||||=|0.779||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 36||||=0.779
71740722|NCT00042991|142993451|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71740723|NCT00042991|142993452|SUPERIORITY_OR_OTHER|||||||0.0546||95.0|||||Wilcoxon (Mann-Whitney)|||19 patients had Enhancing tumor at both Baseline and Post-RT time points. Thus, the following test was based on these 19 patients.||||0.0546
71740724|NCT00042991|142993453|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71740725|NCT00042991|142993454|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
71740726|NCT03058692|142993463|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71740727|NCT03058692|142993463|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
71775842|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.339|TWO_SIDED|95.0|-0.51|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.51|0.339
71775843|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.381|TWO_SIDED|95.0|-0.5|0.19|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.50|0.381
71775844|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.19||0.438|TWO_SIDED|95.0|-0.51|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.51|0.438
71833882|NCT04714320|143171966|SUPERIORITY||||||=|0.323||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.323
71740728|NCT03058692|142993464|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
71661955|NCT00631657|142837261|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.0|||<|0.0001|TWO_SIDED|95.0|-34.5|-15.4|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.|||-15.4|-34.5|<0.0001
71661956|NCT00699374|142837274|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.9993|TWO_SIDED|95.0|1.14|1.5||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.|Log Rank|||||1.50|1.14|0.9993
71740729|NCT03058692|142993464|OTHER|||||||0.73||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.73
71740730|NCT03058692|142993465|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
71740731|NCT03058692|142993465|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
71740732|NCT03058692|142993466|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
71740733|NCT03058692|142993466|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
71740734|NCT03058692|142993467|OTHER|||||||0.0078||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0078
71775845|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.111|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.66|0.111
71775846|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.059|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.72|0.059
71775847|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.282|TWO_SIDED|95.0|-0.57|0.17|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.57|0.282
71775848|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.18||0.927|TWO_SIDED|95.0|-0.37|0.33|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.33|-0.37|0.927
71775849|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.65|0.094
71775850|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.012|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.80|0.012
71775851|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.51|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.51|0.363
71775852|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.742|TWO_SIDED|95.0|-0.32|0.45|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.45|-0.32|0.742
71775853|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.19||0.436|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.53|0.436
71740735|NCT03058692|142993467|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
71740736|NCT03058692|142993468|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71740737|NCT03058692|142993468|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
71775854|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.038|TWO_SIDED|95.0|-0.79|-0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.79|0.038
71740738|NCT03058692|142993469|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71740739|NCT03058692|142993469|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71740740|NCT03058692|142993470|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71740741|NCT03058692|142993471|OTHER|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71740742|NCT03058692|142993471|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.5
71775855|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.332|TWO_SIDED|95.0|-0.57|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.57|0.332
71775856|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
71890813|NCT03293654|143303410|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.12|STANDARD_DEVIATION|0.05|||TWO_SIDED|90.0|1.02|1.22|||||EU Avastin: US Avastin|||1.22|1.02|
71896180|NCT02495077|143314342|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.639|TWO_SIDED|95.0|-5.37|3.3|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.30|-5.37|0.639
71661957|NCT00699374|142837275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8857|TWO_SIDED|95.0|0.99|1.3||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition|Log Rank|||||1.30|0.99|0.8857
71775857|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
71775858|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
71775859|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
71775860|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
71775861|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
71775862|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
71775863|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
71775864|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-0.99|<0.001
71775865|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.06|-0.42|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.42|-1.06|<0.001
71775866|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.29|<0.001
71775867|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.29|-0.65|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.29|<0.001
71833883|NCT04714320|143171966|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 43||||=0.991
71661958|NCT00699374|142837276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8459|TWO_SIDED|95.0|0.98|1.31||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition|Log Rank|||||1.31|0.98|0.8459
71775868|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.95|-0.25|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.25|-0.95|<0.001
71775869|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.32|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.32|-1.02|<0.001
71775870|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.22|-0.51|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.22|<0.001
71775871|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.6|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.60|-1.31|<0.001
71775872|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.86|-0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.86|0.003
71775873|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.24|-0.56|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.24|<0.001
71775874|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.26|-0.57|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.26|<0.001
71775875|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.41|-0.73|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.73|-1.41|<0.001
71775876|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.06|-0.33|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.33|-1.06|<0.001
71833884|NCT04714320|143171966|SUPERIORITY||||||=|0.973||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.973
71661959|NCT03839823|142837280|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.003|TWO_SIDED|95.0|0.429|0.87|||one-sided stratified logrank test|||||0.870|0.429|0.003
71661960|NCT03839823|142837281|SUPERIORITY||Hazard Ratio (HR)|0.497||||||95.0|0.363|0.68||||||||0.680|0.363|
71775877|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.47|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.47|-1.21|<0.001
71775878|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.36|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.36|<0.001
71890814|NCT03093402|143303418|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-0.9||||0.419|TWO_SIDED|95.0|-2.5|0.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for High JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.6|-2.5|0.4190
71890815|NCT03093402|143303418|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Median Difference (Final Values)|-1.2||||0.419|TWO_SIDED|95.0|-2.7|0.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Medium JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.3|-2.7|0.4190
71890816|NCT03093402|143303418|SUPERIORITY|The fixed effects included treatment, time, time² , time- and time² by treatment interactions. The Screening FSS score and the Screening 7-day average maximum daily pain NRS were included as covariates. Within-subject random effects for intercept and slopes for time and time² were fit using an unstructured covariance matrix, assuming a different structure for placebo and pooled active treatment groups.|Mean Difference (Final Values)|-0.7||||0.419|TWO_SIDED|95.0|-2.2|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active treatment arms versus placebo.|Mixed Models Analysis||Mean difference in the change from Day 1 to Day 84 for Low JBT-101 - Placebo. The estimated mean change (95% confidence interval) from Day 1 to Day 84 for Placebo was -0.3 (-1.5, 0.9).|The null hypothesis is that linear trends from Day 1 to Day 84 are equivalent for each active JBT-101 cohort and placebo. The overall test is a 3 degree of freedom F test that simultaneously compares the estimated mean change from Day 1 to Day 84 for each of the 3 active JBT-101 cohorts versus placebo.||0.8|-2.2|0.4190
71890817|NCT03093402|143303428|SUPERIORITY|||||||0.594|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 29.||||0.594
71890818|NCT03093402|143303428|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 57.||||0.487
71890819|NCT03093402|143303428|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 85.||||0.760
71890820|NCT03093402|143303428|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each active treatment vs. placebo at Day 113.||||0.676
71661961|NCT03839823|142837282|SUPERIORITY|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
71661962|NCT03839823|142837283|SUPERIORITY|||||||0.255|||||||Cochran-Mantel-Haenszel|||||||0.255
71890821|NCT03093402|143303429|SUPERIORITY|||||||0.796||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.796
71890822|NCT03093402|143303429|SUPERIORITY|||||||0.955||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.955
71661963|NCT03839823|142837284|SUPERIORITY|||||||0.116|||||||Cochran-Mantel-Haenszel|||||||0.116
71661964|NCT03839823|142837285|SUPERIORITY||Hazard Ratio (HR)|0.762|||||TWO_SIDED|95.0|0.546|1.064||||||||1.064|0.546|
71661965|NCT01517373|142837291|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.145||0.4468|TWO_SIDED|80.0|-0.21|0.17||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.17|-0.21|0.4468
71661966|NCT01517373|142837291|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.0218|TWO_SIDED|80.0|-0.48|-0.11||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.11|-0.48|0.0218
71661967|NCT01517373|142837291|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.144||0.0006|TWO_SIDED|80.0|-0.65|-0.28||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.28|-0.65|0.0006
71661968|NCT01517373|142837291|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.144|<|0.0001|TWO_SIDED|80.0|-1.02|-0.65||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.65|-1.02|<0.0001
71661969|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.087||0.6112|TWO_SIDED|80.0|-0.09|0.14||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.14|-0.09|0.6112
71775879|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.83|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.83|-1.56|<0.001
71775880|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|-0.93|-0.23|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.93|0.001
71775881|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
71775882|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.24|-0.53|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.24|<0.001
71775883|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.05|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.40|<0.001
71775884|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.40|-1.17|<0.001
71775885|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.34|-1.11|<0.001
71775886|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.32|-0.56|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.56|-1.32|<0.001
71775887|NCT00809354|143051255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.51|-0.75|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.75|-1.51|<0.001
71661970|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.088||0.055|TWO_SIDED|80.0|-0.25|-0.03||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.03|-0.25|0.0550
71661971|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.086||0.0032|TWO_SIDED|80.0|-0.35|-0.13||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.13|-0.35|0.0032
71775888|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.887|TWO_SIDED|95.0|-0.33|0.28|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.33|0.887
71775889|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.046|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.62|0.046
71775890|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.16||0.771|TWO_SIDED|95.0|-0.26|0.35|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.35|-0.26|0.771
71775891|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.16||0.032|TWO_SIDED|95.0|0.03|0.64|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.64|0.03|0.032
71775892|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.17||0.223|TWO_SIDED|95.0|-0.13|0.54|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.54|-0.13|0.223
71740743|NCT03058692|142993472|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
71740744|NCT03058692|142993472|OTHER|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.74
71740745|NCT03058692|142993473|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
71740746|NCT03058692|142993473|OTHER|||||||0.9||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.90
71740747|NCT03058692|142993474|OTHER|||||||0.87||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.87
71740748|NCT03058692|142993474|OTHER|||||||0.57||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.57
71775893|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.17||0.718|TWO_SIDED|95.0|-0.39|0.27|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.39|0.718
71775894|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.17||0.495|TWO_SIDED|95.0|-0.45|0.22|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.45|0.495
71775895|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.389|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.47|0.389
71775896|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.035|TWO_SIDED|95.0|-0.68|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.68|0.035
71775897|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.155|TWO_SIDED|95.0|-0.56|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.56|0.155
71775898|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.876|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.30|-0.35|0.876
71775899|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.864|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.33|0.864
71661972|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.086|<|0.0001|TWO_SIDED|80.0|-0.55|-0.33||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.33|-0.55|<0.0001
71775900|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.18||0.338|TWO_SIDED|95.0|-0.54|0.18|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.54|0.338
71775901|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.101|TWO_SIDED|95.0|-0.66|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.66|0.101
71775902|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.605|TWO_SIDED|95.0|-0.46|0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.27|-0.46|0.605
71661973|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.101||0.6146|TWO_SIDED|80.0|-0.1|0.16||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.16|-0.10|0.6146
71661974|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.101||0.2606|TWO_SIDED|80.0|-0.19|0.06||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.19|0.2606
71661975|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.099||0.0006|TWO_SIDED|80.0|-0.45|-0.2||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0006
71661976|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|80.0|-0.7|-0.44||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.44|-0.70|<0.0001
71661977|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.118||0.6618|TWO_SIDED|80.0|-0.1|0.2||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.20|-0.10|0.6618
71661978|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.119||0.0878|TWO_SIDED|80.0|-0.31|-0.01||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-0.31|0.0878
71661979|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.117||0.0022|TWO_SIDED|80.0|-0.49|-0.19||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.19|-0.49|0.0022
71661980|NCT01517373|142837292|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.117|<|0.0001|TWO_SIDED|80.0|-0.81|-0.51||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.51|-0.81|<0.0001
71661981|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|5.222||0.3446|TWO_SIDED|80.0|-8.8|4.62||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.62|-8.80|0.3446
71661982|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.12|STANDARD_ERROR_OF_MEAN|5.21||0.1204|TWO_SIDED|80.0|-12.81|0.57||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-12.81|0.1204
71661983|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.74|STANDARD_ERROR_OF_MEAN|5.166||0.0041|TWO_SIDED|80.0|-20.37|-7.1||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.10|-20.37|0.0041
71661984|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.34|STANDARD_ERROR_OF_MEAN|5.192|<|0.0001|TWO_SIDED|80.0|-28.01|-14.67||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-14.67|-28.01|<0.0001
71661985|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.14|STANDARD_ERROR_OF_MEAN|5.191||0.1616|TWO_SIDED|80.0|-11.8|1.53||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.53|-11.80|0.1616
71661986|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|STANDARD_ERROR_OF_MEAN|5.219||0.1974|TWO_SIDED|80.0|-11.15|2.26||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.26|-11.15|0.1974
71661987|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|5.14||0.0122|TWO_SIDED|80.0|-18.22|-5.02||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.02|-18.22|0.0122
71661988|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.79|STANDARD_ERROR_OF_MEAN|5.129|<|0.0001|TWO_SIDED|80.0|-31.37|-18.2||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-18.20|-31.37|<0.0001
71775903|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.013|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.78|0.013
71661989|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|5.674||0.3645|TWO_SIDED|80.0|-9.26|5.32||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.32|-9.26|0.3645
71661990|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|5.676||0.3672|TWO_SIDED|80.0|-9.22|5.36||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.22|0.3672
71661991|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|5.598||0.0906|TWO_SIDED|80.0|-14.69|-0.31||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.31|-14.69|0.0906
71661992|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.69|STANDARD_ERROR_OF_MEAN|5.624||0.0003|TWO_SIDED|80.0|-26.91|-12.46||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.46|-26.91|0.0003
71661993|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.18|STANDARD_ERROR_OF_MEAN|5.534||0.1748|TWO_SIDED|80.0|-12.29|1.93||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.93|-12.29|0.1748
71661994|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.54|STANDARD_ERROR_OF_MEAN|5.566||0.0297|TWO_SIDED|80.0|-17.69|-3.38||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.38|-17.69|0.0297
71661995|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.44|STANDARD_ERROR_OF_MEAN|5.469||0.0118|TWO_SIDED|80.0|-19.47|-5.41||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.41|-19.47|0.0118
71661996|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.0|STANDARD_ERROR_OF_MEAN|5.48|<|0.0001|TWO_SIDED|80.0|-34.04|-19.96||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-19.96|-34.04|<0.0001
71661997|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.03|STANDARD_ERROR_OF_MEAN|6.281||0.1012|TWO_SIDED|80.0|-16.1|0.04||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.04|-16.10|0.1012
71661998|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.99|STANDARD_ERROR_OF_MEAN|6.287||0.0409|TWO_SIDED|80.0|-19.07|-2.91|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.91|-19.07|0.0409
71661999|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.87|STANDARD_ERROR_OF_MEAN|6.232||0.0089|TWO_SIDED|80.0|-22.88|-6.86|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-6.86|-22.88|0.0089
71662000|NCT01517373|142837293|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.93|STANDARD_ERROR_OF_MEAN|6.233|<|0.0001|TWO_SIDED|80.0|-33.93|-17.92||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-17.92|-33.93|<0.0001
71662001|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.196||0.0898|TWO_SIDED|80.0|0.08|0.59||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|0.08|0.0898
71662002|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.195||0.0555|TWO_SIDED|80.0|0.12|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|0.12|0.0555
71662003|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0585|TWO_SIDED|80.0|0.12|0.61||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.61|0.12|0.0585
71662004|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.194||0.0454|TWO_SIDED|80.0|0.14|0.64||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.64|0.14|0.0454
71775904|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.84|0.005
71662005|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.235||0.2819|TWO_SIDED|80.0|-0.05|0.55||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-0.05|0.2819
71662006|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.235||0.0319|TWO_SIDED|80.0|0.2|0.81||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.81|0.20|0.0319
71662007|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.231||0.1835|TWO_SIDED|80.0|0.01|0.6||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.60|0.01|0.1835
71662008|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|0.231||0.0001|TWO_SIDED|80.0|0.63|1.22||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.22|0.63|0.0001
71662009|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.9689|TWO_SIDED|80.0|-0.35|0.33||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.33|-0.35|0.9689
71662010|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.265||0.2221|TWO_SIDED|80.0|-0.02|0.67||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.02|0.2221
71662011|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.261||0.2774|TWO_SIDED|80.0|-0.05|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.05|0.2774
71662012|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|80.0|0.76|1.43||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.43|0.76|<0.0001
71662013|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.314||0.0667|TWO_SIDED|80.0|0.17|0.98||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.98|0.17|0.0667
71662014|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.314||0.0133|TWO_SIDED|80.0|0.38|1.19||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.19|0.38|0.0133
71662015|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.308||0.026|TWO_SIDED|80.0|0.29|1.08||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|0.29|0.0260
71662016|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|80.0|1.23|2.02||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.02|1.23|<0.0001
71662017|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.374||0.0335|TWO_SIDED|80.0|0.32|1.28||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.28|0.32|0.0335
71662018|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.373||0.1557|TWO_SIDED|80.0|0.05|1.01||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.01|0.05|0.1557
71775905|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.199|TWO_SIDED|95.0|-0.57|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.57|0.199
71775906|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.363|TWO_SIDED|95.0|-0.5|0.18|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.50|0.363
71775907|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.613|TWO_SIDED|95.0|-0.47|0.28|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.28|-0.47|0.613
71775908|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.19||0.416|TWO_SIDED|95.0|-0.53|0.22|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.22|-0.53|0.416
71662019|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|0.368||0.0132|TWO_SIDED|80.0|0.45|1.39||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.39|0.45|0.0132
71662020|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|80.0|2.2|3.15||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.15|2.20|<0.0001
71662021|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.394||0.0158|TWO_SIDED|80.0|0.45|1.46||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.46|0.45|0.0158
71662022|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.392||0.2132|TWO_SIDED|80.0|-0.01|0.99||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.99|-0.01|0.2132
71662023|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.387||0.0263|TWO_SIDED|80.0|0.37|1.36||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.36|0.37|0.0263
71662024|NCT01517373|142837301|SUPERIORITY_OR_OTHER||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|80.0|2.12|3.12||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|2.12|<0.0001
71662025|NCT01243112|142837303|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||ANOVA|||Null Hypothesis is that no difference would be measured between treatment arms.||||0.359
71662026|NCT01243112|142837304|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANOVA|||||||0.490
71662027|NCT04562155|142837305|SUPERIORITY||||||=|0.0345||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=30) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0345
71662028|NCT04562155|142837305|SUPERIORITY||||||=|0.0376||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: Emax model (ED50=50) Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0376
71775909|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.143|TWO_SIDED|95.0|-0.66|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.66|0.143
71890823|NCT03093402|143303429|SUPERIORITY|||||||0.211||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.211
71890824|NCT03093402|143303429|SUPERIORITY|||||||0.481||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 50% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.481
71775910|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.245|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.60|0.245
71662029|NCT04562155|142837305|SUPERIORITY||||||=|0.0319||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=30, h=3) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0319
71662030|NCT04562155|142837305|SUPERIORITY||||||=|0.0603||||||Adjusted p-value|MCP-Mod method|||Detection of dose-response: sigm. Emax model (ED50=60, h=5) sigm = sigmoidal h = hill parameter Dose response relationship was assessed using the MCP-Mod method combining multiple comparison procedures (MCP) principles with modeling techniques. A generalized MCP approach (with adjustment for baseline cough count and geographic region) was applied to calculate the adjusted one-sided p-values of the contrast test. Pre-specified overall Type one error at alpha level of 0.1 (one-sided).||||= 0.0603
71890825|NCT03093402|143303430|SUPERIORITY|||||||0.79||||||This p-value is from an exact likelihood ratio test at Day 29 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.790
71890826|NCT03093402|143303430|SUPERIORITY|||||||0.843||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.843
71890827|NCT03093402|143303430|SUPERIORITY|||||||0.637||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.637
71740749|NCT03058692|142993475|OTHER|||||||0.82||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.82
71740750|NCT03058692|142993475|OTHER|||||||0.076||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.076
71740751|NCT03058692|142993476|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>0.99
71740752|NCT03058692|142993476|OTHER|||||||0.75||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.75
71740753|NCT03058692|142993477|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
71740754|NCT03058692|142993477|OTHER|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.50
71740755|NCT03058692|142993478|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
71740756|NCT03058692|142993478|OTHER||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||>.99
71662031|NCT00790335|142837314|SUPERIORITY||Risk Ratio (RR)|0.96||||0.56|TWO_SIDED|95.0|0.82|1.11|||Cochran-Mantel-Haenszel|Adjusted for extent of DVT and for clinical center|Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.|||1.11|0.82|0.56
71662032|NCT00790335|142837315|SUPERIORITY||Risk Ratio (RR)|0.58||||0.38|TWO_SIDED|95.0|0.17|1.98|||Cochran-Mantel-Haenszel|Adjusted by extent of thrombus and clinical center|Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.|||1.98|0.17|0.38
71662033|NCT00790335|142837316|SUPERIORITY||Risk Ratio (RR)|0.94||||0.39|TWO_SIDED|95.0|0.8|1.09|||Cochran-Mantel-Haenszel|Adjusted for thrombus extent and clinical center|No statistically significant difference was seen.|||1.09|0.80|0.39
71662034|NCT00790335|142837317|SUPERIORITY||Risk Ratio (RR)|0.73||||0.04|TWO_SIDED|95.0|0.54|0.98|||Cochran-Mantel-Haenszel|Adjusted by extent of DVT and clinical center|Numerator: PCDT Arm; Denominator: Control Arm|||0.98|0.54|0.04
71775911|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.745|TWO_SIDED|95.0|-0.41|0.29|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|-0.41|0.745
71662035|NCT00790335|142837318|SUPERIORITY||Risk Ratio (RR)|6.18||||0.049|TWO_SIDED|95.0|0.78|49.2|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.|||49.2|0.78|0.049
71662036|NCT00790335|142837319|SUPERIORITY||Risk Ratio (RR)|1.52||||0.23|TWO_SIDED|95.0|0.76|3.01|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||3.01|0.76|0.23
71890828|NCT03093402|143303430|SUPERIORITY|||||||0.243||||||This p-value is from an exact likelihood ratio test at Day 113 testing that the proportion of subjects with \>= 75% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||||||0.243
71662037|NCT00790335|142837320|SUPERIORITY||Risk Ratio (RR)|2.64||||0.03|TWO_SIDED|95.0|1.04|6.68|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.|||6.68|1.04|0.03
71662038|NCT00790335|142837321|SUPERIORITY||Risk Ratio (RR)|1.26||||0.25|TWO_SIDED|95.0|0.85|1.89|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||1.89|0.85|0.25
71662039|NCT00790335|142837322|SUPERIORITY||Risk Ratio (RR)|1.53||||0.5|TWO_SIDED|95.0|0.44|5.28|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm|||5.28|0.44|0.50
71662040|NCT00790335|142837323|SUPERIORITY||Risk Ratio (RR)|1.47||||0.09|TWO_SIDED|95.0|0.94|2.29|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm|||2.29|0.94|0.09
71662041|NCT00790335|142837325|SUPERIORITY||Risk Ratio (RR)|0.89||||0.83|TWO_SIDED|95.0|0.33|2.44|||Cochran-Mantel-Haenszel|||||2.44|0.33|0.83
71775912|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.062|TWO_SIDED|95.0|-0.69|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.69|0.062
71890829|NCT03093402|143303431|SUPERIORITY||||||>|0.999||||||This p-value is from an exact likelihood ratio test at Day 57 testing that the proportion of subjects with \>=100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||>0.999
71890830|NCT03093402|143303431|SUPERIORITY|||||||0.861||||||This p-value is from an exact likelihood ratio test at Day 85 testing that the proportion of subjects with \>= 100% improvement is equal among the 4 treatment groups.|Exact Likelihood Ratio Test|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.861
71890831|NCT03093402|143303432|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.39|TWO_SIDED|95.0|-4.8|8.7||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for High JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.7|-4.8|0.390
71890832|NCT03093402|143303432|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.39|TWO_SIDED|95.0|-4.9|8.2||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Medium JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||8.2|-4.9|0.390
71890833|NCT03093402|143303432|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.39|TWO_SIDED|95.0|-8.6|4.6||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline tender joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline tender joint count for Low JBT-101 - Placebo. The estimated tender joint count mean change from baseline (95% confidence interval) for Placebo was -6.3 (-12.0, -0.7).|Each active JBT-101 cohort is compared to placebo.||4.6|-8.6|0.390
71890834|NCT03093402|143303433|SUPERIORITY||Median Difference (Final Values)|0.7||||0.556|TWO_SIDED|95.0|-1.6|3.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||3.0|-1.6|0.556
71662042|NCT00790335|142837326|SUPERIORITY||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71662043|NCT00790335|142837327|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71890835|NCT03093402|143303433|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.556|TWO_SIDED|95.0|-2.5|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each JBT-101 cohort versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for Medium JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||2.0|-2.5|0.556
71890836|NCT03093402|143303433|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.556|TWO_SIDED|95.0|-3.1|1.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline swollen joint count at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline swollen joint count for High JBT-101 - Placebo. The estimated swollen joint count mean change from baseline (95% confidence interval) for Placebo was -4.0 (-5.7, -2.4).|Each active JBT-101 cohort is compared to placebo.||1.4|-3.1|0.556
71890837|NCT03093402|143303434|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||0.669
71662044|NCT00790335|142837328|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71775913|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.8|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.80|0.014
71662045|NCT00790335|142837329|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.38||0.005|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.005
71740757|NCT03058692|142993479|OTHER|||||||0.81||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.81
71740758|NCT03058692|142993479|OTHER|||||||0.47||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.47
71740759|NCT03058692|142993480|OTHER|||||||0.0061||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0061
71775914|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.367|TWO_SIDED|95.0|-0.52|0.19|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.52|0.367
71775915|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.995|TWO_SIDED|95.0|-0.39|0.39|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.39|-0.39|0.995
71775916|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.735|TWO_SIDED|95.0|-0.46|0.32|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.32|-0.46|0.735
71775917|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.169|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.67|0.169
71775918|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.295|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.18|-0.60|0.295
71775919|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.284|TWO_SIDED|95.0|-0.47|0.14|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.47|0.284
71775920|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.224|TWO_SIDED|95.0|-0.5|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.50|0.224
71775921|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.16||0.002|TWO_SIDED|95.0|-0.79|-0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.17|-0.79|0.002
71775922|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.355|TWO_SIDED|95.0|-0.45|0.16|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.16|-0.45|0.355
71775923|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.172|TWO_SIDED|95.0|-0.57|0.1|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.57|0.172
71775924|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.882|TWO_SIDED|95.0|-0.36|0.31|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.31|-0.36|0.882
71775925|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.63|0.04|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.63|0.084
71775926|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.405|TWO_SIDED|95.0|-0.47|0.19|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.47|0.405
71775927|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-0.94|<0.001
71775928|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.09|-0.44|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.44|-1.09|<0.001
71775929|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.3|-0.64|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.64|-1.30|<0.001
71775930|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.32|-0.67|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.67|-1.32|<0.001
71662046|NCT00790335|142837330|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71662047|NCT00790335|142837331|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.23||0.01|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.01
71662048|NCT00790335|142837332|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||< 0.001
71662049|NCT00790335|142837333|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm|||||0.03
71662050|NCT00790335|142837334|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.26||0.37|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.|||||0.37
71662051|NCT00790335|142837335|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.16||0.99|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.|||||0.99
71662052|NCT00790335|142837336|SUPERIORITY||Mean Difference (Net)|4.2|STANDARD_ERROR_OF_MEAN|2.39||0.08|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference in the change from baseline to 24 months between the two treatment arms.|||||0.08
71662053|NCT00790335|142837337|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
71662054|NCT00790335|142837338|SUPERIORITY||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.03|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.03
71662055|NCT00790335|142837339|SUPERIORITY||Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.23||0.02|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.02
71740760|NCT03058692|142993480|OTHER|||||||0.28||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.28
71740761|NCT03058692|142993481|OTHER|||||||0.36||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.36
71740762|NCT03058692|142993481|OTHER|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.32
71662056|NCT00790335|142837340|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED||||||Regression, Linear|Adjusted by extent of thrombus and clinical center||||||0.05
71662057|NCT02699060|142837344|SUPERIORITY||Median Difference (Net)|-1.76|STANDARD_DEVIATION|0.8||0.002|TWO_SIDED||||||Mixed Models Analysis|||||||0.002
71662058|NCT04516759|142837345|SUPERIORITY||Risk Ratio (RR)|1.09||||0.1854|TWO_SIDED|95.0|0.9|1.32|||Chi-squared|Chi-squared test on the one-sided significance level of 2.5%||||1.32|0.9|0.1854
71662059|NCT04516759|142837346|OTHER|||||||0.0286||||||Baseline p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0286
71662060|NCT04516759|142837346|OTHER|||||||0.0786||||||Day 7 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.0786
71662061|NCT04516759|142837346|OTHER|||||||0.2169||||||Day 14 p-value|Wilcoxon (Mann-Whitney)|one-side significance level of 2.5%||||||0.2169
71662062|NCT04516759|142837346|OTHER|||||||0.186||||||Day 21 p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.1860
71662063|NCT04516759|142837346|OTHER|||||||0.2256||||||Study Drug Discontinuation (SDD) p-value|Wilcoxon (Mann-Whitney)|one-sided significance level of 2.5%||||||0.2256
71662064|NCT04516759|142837347|OTHER|||||||0.4006||||||Increase in Diabetic Medication needed equal or more than 3 days|Fisher Exact|||||||0.4006
71662065|NCT04516759|142837347|OTHER|||||||0.7482||||||Diabetic Medication is stable/reduced equal or more than 3 days|Fisher Exact|||||||0.7482
71662066|NCT04516759|142837347|OTHER|||||||0.6949||||||Increase in Diabetic Medication needed at any time during the study|Fisher Exact|||||||0.6949
71662067|NCT04516759|142837347|OTHER|||||||0.5521||||||Diabetic Medication is stable/reduced at any time during the study|Fisher Exact|||||||0.5521
71662068|NCT04516759|142837348|OTHER|||||||0.5875|||||||Fisher Exact|||||||0.5875
71662069|NCT04516759|142837349|OTHER|||||||0.1129|||||||Fisher Exact|||||||0.1129
71740763|NCT03058692|142993482|OTHER|||||||0.42||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.42
71740764|NCT03058692|142993482|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
71740765|NCT03058692|142993483|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71740766|NCT03058692|142993483|OTHER|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.56
71833885|NCT04714320|143171966|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 50||||=0.230
71740767|NCT03058692|142993484|OTHER|||||||0.97||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.97
71740768|NCT03058692|142993484|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
71775931|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.30|-1.02|<0.001
71775932|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-0.99|-0.27|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.99|<0.001
71775933|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.48|-1.19|<0.001
71775934|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.29|-0.57|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.57|-1.29|<0.001
71775935|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.89|-0.2|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.20|-0.89|0.002
71775936|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.32|-0.63|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.63|-1.32|<0.001
71775937|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.7|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.70|-1.39|<0.001
71775938|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.55|-0.86|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.86|-1.55|<0.001
71775939|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.18|-0.43|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.43|-1.18|<0.001
71662070|NCT04516759|142837350|SUPERIORITY|||||||0.1556|||||||Log Rank|||||||0.1556
71662071|NCT04516759|142837351|OTHER||Risk Ratio (RR)|0.41||||0.0903|TWO_SIDED|95.0|0.13|1.26|||Fisher Exact|The p-value is assessed by means of an Fisher's exact test on the one-sided significance level of 2.5%||||1.26|0.13|0.0903
71662072|NCT04516759|142837352|OTHER|||||||0.6144|||||||Fisher Exact|One-sided significance level of 2.5%||||||0.6144
71662073|NCT04516759|142837353|OTHER|||||||0.0105|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.0105
71662074|NCT04516759|142837354|OTHER|||||||0.062|||||||Fisher Exact|one-sided significance level of 2.5%||||||0.062
71662075|NCT04916444|142837355|SUPERIORITY|||||||0.691|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the TWSTRS scores.||||0.691
71662076|NCT04916444|142837356|SUPERIORITY|||||||0.816|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the BDI scores.||||0.816
71662077|NCT04916444|142837357|SUPERIORITY|||||||0.167|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.167
71740769|NCT03058692|142993485|OTHER|||||||0.15||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.15
71740770|NCT03058692|142993485|OTHER|||||||0.18||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.18
71662078|NCT04916444|142837358|SUPERIORITY|||||||0.507|||||||ANOVA|Two-way repeated measures ANOVA||Null hypothesis is that there was no interaction between the intervention and time factors on the time to complete the TMT-A task.||||0.507
71775940|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.28|-0.53|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.53|-1.28|<0.001
71775941|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.33|<0.001
71775942|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.56|-0.81|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.56|<0.001
71775943|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.02|-0.31|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.31|-1.02|<0.001
71775944|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.08|-0.37|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.37|-1.08|<0.001
71662079|NCT04916444|142837359|SUPERIORITY|||||||0.056|||||||ANOVA|Two-way repeated measures ANOVA||||||0.056
71662080|NCT04916444|142837360|SUPERIORITY|||||||0.646|||||||ANOVA|Two-way repeated measures ANOVA||||||0.646
71662081|NCT02695537|142837397|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
71662082|NCT02695537|142837398|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
71662083|NCT02737748|142837416|OTHER|||||||0.2217|||||||Cochran-Mantel-Haenszel|||||||0.2217
71662084|NCT02737748|142837417|OTHER|||||||0.0324|||||||Cochran-Mantel-Haenszel|||||||0.0324
71662085|NCT02737748|142837418|OTHER|||||||0.3975|||||||Log Rank|||||||0.3975
71662086|NCT00423319|142837469|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.22|0.54||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.54|0.22|<0.0001
71662087|NCT00423319|142837469|SUPERIORITY_OR_OTHER||Risk Difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.54|1.5||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||1.50|-3.54|<0.0001
71662088|NCT00423319|142837470|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.15|0.8||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin|||0.80|0.15|<0.0001
71662089|NCT00423319|142837470|SUPERIORITY_OR_OTHER||Risk difference|-0.68||||0.0054|TWO_SIDED|95.0|-1.27|-0.17||Statistically significant at the 1-sided 0.025 level|Chi-squared||Apixaban-enoxaparin|||-0.17|-1.27|0.0054
71662090|NCT00423319|142837472|SUPERIORITY_OR_OTHER||Difference in event rates|0.15||||0.54|TWO_SIDED|95.0|-0.33|0.64||2-sided P-Value|Chi-squared||Major bleeding. Apixaban-enoxaparin|||0.64|-0.33|0.54
71662091|NCT00423319|142837472|SUPERIORITY_OR_OTHER||Difference in event rates|-0.44||||0.43|TWO_SIDED|95.0|-1.53|0.66||2-sided P-Value|Chi-squared||CRNM. Apixaban-enoxaparin|||0.66|-1.53|0.43
71775945|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.36|-0.65|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.65|-1.36|<0.001
71775946|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.52|-0.81|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.81|-1.52|<0.001
71775947|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.29|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.29|<0.001
71775948|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.3|-0.51|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.51|-1.30|<0.001
71833886|NCT04714320|143171966|SUPERIORITY||||||=|0.792||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.792
71833887|NCT04714320|143171966|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 57||||=0.744
71833888|NCT04714320|143171966|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.925|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.925
71833889|NCT04714320|143171966|SUPERIORITY||||||=|0.991||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 64||||=0.991
71833890|NCT04714320|143171966|SUPERIORITY|Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|||||=|0.53|||||||Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.530
71833891|NCT04714320|143171966|SUPERIORITY||||||=|0.849||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 71||||=0.849
71662092|NCT00423319|142837472|SUPERIORITY_OR_OTHER||Difference in event rates|-0.21||||0.72|TWO_SIDED|95.0|-1.38|0.95||2-sided P-Value|Chi-squared||Major or CRNM. Apixaban-enoxaparin|||0.95|-1.38|0.72
71662093|NCT00423319|142837472|SUPERIORITY_OR_OTHER||Difference in event rate|-0.85||||0.34|TWO_SIDED|95.0|-2.61|0.9||2-sided P-Value|Chi-squared||Any bleeding. Apixaban-enoxaparin|||0.90|-2.61|0.34
71775949|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.36|-0.58|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.58|-1.36|<0.001
71662094|NCT00423319|142837482|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||Apixaban-enoxaparin. MI/stroke|||0.26|-0.34|
71662095|NCT00423319|142837482|SUPERIORITY_OR_OTHER||Difference in event rates|0.07|||||TWO_SIDED|95.0|-0.17|0.34|||||Apixaban-enoxaparin. MI|||0.34|-0.17|
71662096|NCT00423319|142837482|SUPERIORITY_OR_OTHER||Difference in event rates|-0.11|||||TWO_SIDED|95.0|-0.35|0.07|||||Apixaban-enoxaparin. Stroke|||0.07|-0.35|
71662097|NCT00423319|142837482|SUPERIORITY_OR_OTHER||Difference in event rates|-0.04|||||TWO_SIDED|95.0|-0.26|0.17|||||Apixaban-enoxaparin. Thrombocytopenia|||0.17|-0.26|
71662098|NCT01584843|142837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83||||0.091|TWO_SIDED|95.0|-21.81|2.14||LSD=Least Significant Difference|Fisher LSD method|||||2.14|-21.81|0.091
71662099|NCT01584843|142837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.08||||0.338|TWO_SIDED|95.0|-20.39|8.23|||Fisher LSD method|||||8.23|-20.39|0.338
71662100|NCT01584843|142837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.524|TWO_SIDED|95.0|-9.83|17.33|||Fisher LSD method|||||17.33|-9.83|0.524
71662101|NCT01584843|142837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.85||||0.031|TWO_SIDED|95.0|-24.46|-1.24|||Fisher LSD method|||||-1.24|-24.46|0.031
71662102|NCT01584843|142837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.72||||0.005|TWO_SIDED|95.0|-28.06|-5.38|||Fisher LSD method|||||-5.38|-28.06|0.005
71662103|NCT01584843|142837483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.87||||0.49|TWO_SIDED|95.0|-15.21|7.47|||Fisher LSD method|||||7.47|-15.21|0.490
71890838|NCT03093402|143303434|SUPERIORITY|||||||0.432|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||0.432
71890839|NCT03093402|143303434|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||0.780
71890840|NCT03093402|143303434|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||0.285
71890841|NCT03093402|143303436|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 29.||||||0.872|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.872
71890842|NCT03093402|143303436|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 57.||||||0.895|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.895
71662104|NCT00311402|142837500|NON_INFERIORITY_OR_EQUIVALENCE|The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.|Cox Proportional Hazard|1.47||||0.097||95.0|0.93|2.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.31|0.93|0.097
71662105|NCT00311402|142837501|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.79||||0.223||95.0|0.7|4.54|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||4.54|0.70|0.223
71662106|NCT00311402|142837502|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.0||||0.998|ONE_SIDED|95.0|0.0||||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|||0|0.998
71662107|NCT00311402|142837503|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.977||95.0|0.21|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.21|0.977
71890843|NCT03093402|143303436|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 85.||||||0.669|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.669
71662108|NCT00311402|142837504|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58||||0.192||95.0|0.26|1.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.31|0.26|0.192
71662109|NCT00311402|142837505|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.88||||0.215||95.0|0.69|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||5.07|0.69|0.215
71833892|NCT04714320|143171966|SUPERIORITY||||||=|0.953||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.953
71833893|NCT04714320|143171966|SUPERIORITY||||||=|0.884||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 78||||=0.884
71833894|NCT04714320|143171966|SUPERIORITY||||||=|0.23||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.230
71662110|NCT00311402|142837506|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.16||||0.443||95.0|0.79|1.69|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.69|0.79|0.443
71662111|NCT00311402|142837507|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.52||||0.043||95.0|1.01|2.29|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.29|1.01|0.043
71890844|NCT03093402|143303436|SUPERIORITY|The dichotomous outcome is modeled using the generalized estimating equations approach under the binomial distribution with a logit link. The model includes fixed effects for visit, treatment and visit\*treatment interaction with an unstructured within-subject correlation structure across visits. The overall test p-value is a 3 degree-of-freedom test comparing each of the 3 active treatments vs. placebo at Day 113.||||||0.668|||||||Mixed Models Analysis|||JBT-101 High, JBT-101 Medium, JBT-101 Low, Placebo||||0.668
71890845|NCT03093402|143303437|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.82|TWO_SIDED|95.0|-2.3|1.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for High JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.5|-2.3|.820
71890846|NCT03093402|143303437|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.82|TWO_SIDED|95.0|-2.0|1.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Medium JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.8|-2.0|.820
71890847|NCT03093402|143303437|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.82|TWO_SIDED|95.0|-2.6|1.1||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline SELENA-SLEDAI Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline SLEDAI score for Low JBT-101 - Placebo. The estimated Day 85 SLEDAI mean change from baseline (95% confidence interval) for Placebo was -2.2 (-3.6, -0.8).|Each active JBT-101 cohort is compared to placebo.||1.1|-2.6|.820
71890848|NCT03093402|143303438|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.244|TWO_SIDED|95.0|-3.0|4.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||4.4|-3.0|.244
71890849|NCT03093402|143303438|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.244|TWO_SIDED|95.0|-5.2|2.0||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Medium JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||2.0|-5.2|.244
71662112|NCT00311402|142837508|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.919||95.0|0.48|2.25|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||2.25|0.48|0.919
71662113|NCT00311402|142837509|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.34||||0.101||95.0|0.94|1.91|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.||1.91|0.94|0.101
71662114|NCT02640053|142837510|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71775950|NCT00809354|143051256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.2|<|0.01|TWO_SIDED|95.0|-1.57|-0.79|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.79|-1.57|<0.01
71775951|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
71662115|NCT02640053|142837511|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71662116|NCT02640053|142837512|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71662117|NCT02640053|142837513|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71662118|NCT02640053|142837514|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71662119|NCT02640053|142837515|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71775952|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
71775953|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
71775954|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
71775955|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
71775956|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
71662120|NCT02640053|142837516|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71662121|NCT02640053|142837517|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
71775957|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
71662122|NCT02036775|142837525|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|110.68|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|99.84|122.69|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||122.69|99.84|
71662123|NCT02036775|142837525|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
71662124|NCT02036775|142837525|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|106.93|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|100.29|114.02|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||114.02|100.29|
71662125|NCT02036775|142837526|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|84.72|STANDARD_DEVIATION|19.01|||TWO_SIDED|90.0|76.96|93.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||93.25|76.96|
71662126|NCT02036775|142837526|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|103.87|STANDARD_DEVIATION|17.19|||TWO_SIDED|90.0|95.22|113.31|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||113.31|95.22|
71662127|NCT02036775|142837526|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|80.94|STANDARD_DEVIATION|17.95|||TWO_SIDED|90.0|73.92|88.62|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||88.62|73.92|
71662128|NCT02036775|142837527|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|88.54|STANDARD_DEVIATION|20.42|||TWO_SIDED|90.0|79.87|98.15|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||98.15|79.87|
71662129|NCT02036775|142837527|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|STANDARD_DEVIATION|13.52|||TWO_SIDED|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||110.74|96.54|
71662130|NCT02036775|142837527|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|85.55|STANDARD_DEVIATION|12.65|||TWO_SIDED|90.0|80.23|91.22|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||91.22|80.23|
71833895|NCT04714320|143171966|SUPERIORITY||||||=|0.589||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 85||||=0.589
71833896|NCT04714320|143171966|SUPERIORITY||||||=|0.919||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.919
71662131|NCT02036775|142837528|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|76.55|STANDARD_DEVIATION|14.55|||TWO_SIDED|90.0|71.1|82.4|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||82.40|71.10|
71662132|NCT02036775|142837528|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|100.46|STANDARD_DEVIATION|11.65|||TWO_SIDED|90.0|94.69|106.58|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||106.58|94.69|
71662133|NCT02036775|142837528|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|75.69|STANDARD_DEVIATION|15.64|||TWO_SIDED|90.0|69.92|81.93|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))|||81.93|69.92|
71775958|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
71775959|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.207|TWO_SIDED|95.0|-0.2|0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.20|0.207
71775960|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.02|TWO_SIDED|95.0|-0.27|-0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.27|0.020
71775961|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.941|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.13|0.941
71775962|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.494|TWO_SIDED|95.0|-0.18|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.18|0.494
71775963|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
71775964|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.467|TWO_SIDED|95.0|-0.18|0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.18|0.467
71775965|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.774|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.774
71775966|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.315|TWO_SIDED|95.0|-0.06|0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.19|-0.06|0.315
71775967|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.088|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.088
71833897|NCT04714320|143171966|SUPERIORITY||||||=|0.753||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 92||||=0.753
71775968|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.084|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.084
71833898|NCT04714320|143171966|SUPERIORITY||||||=|0.747||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.747
71662134|NCT00678886|142837537|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.813|TWO_SIDED|95.0|-0.06|0.08|||Mixed effects repeated measures model|||Mixed meal-stimulated C-peptide AUC, Placebo Vs Otelixizumab at Month 12||0.08|-0.06|0.813
71775969|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.066|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.066
71775970|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.073|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.073
71775971|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.682|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.682
71775972|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.014|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.014
71775973|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|-0.28|-0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.02|-0.28|0.027
71775974|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.871|TWO_SIDED|95.0|-0.14|0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.14|0.871
71775975|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.301
71775976|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.181|TWO_SIDED|95.0|-0.23|0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.23|0.181
71775977|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.3|-0.04|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.30|0.013
71775978|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.031|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.031
71662135|NCT00678886|142837538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.737|TWO_SIDED|95.0|0.47|1.7|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Week 12||1.70|0.47|0.737
71662136|NCT00678886|142837538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.737|TWO_SIDED|95.0|0.42|1.39|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 6||1.39|0.42|0.737
71662137|NCT00678886|142837538|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.481|TWO_SIDED|95.0|0.45|1.46|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 12||1.46|0.45|0.481
71662138|NCT00678886|142837539|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.281|TWO_SIDED|95.0|-0.07|0.01|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Week 12||0.01|-0.07|0.281
71662139|NCT00678886|142837539|SUPERIORITY||Mean Difference (Net)|0.0||||0.969|TWO_SIDED|95.0|-0.05|0.05|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 6||0.05|-0.05|0.969
71662140|NCT00678886|142837539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.272|TWO_SIDED|95.0|-0.08|0.02|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 12||0.02|-0.08|0.272
71740771|NCT03058692|142993486|OTHER|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.94
71740772|NCT03058692|142993486|OTHER|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.|||
71890850|NCT03093402|143303438|SUPERIORITY||Median Difference (Final Values)|-2.6||||0.244|TWO_SIDED|95.0|-6.2|0.9||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline BILAG total score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline BILAG score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.3 (-7.0, -1.5).|Each active JBT-101 cohort is compared to placebo.||0.9|-6.2|.244
71890851|NCT03093402|143303439|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.408|TWO_SIDED|95.0|-0.27|0.4||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.40|-0.27|0.408
71662141|NCT00678886|142837540|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18||||0.289|TWO_SIDED|95.0|-0.16|0.52|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 12||0.52|-0.16|0.289
71740773|NCT03058692|142993487|OTHER|||||||0.14||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.14
71775979|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.874|TWO_SIDED|95.0|-0.15|0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.15|0.874
71662142|NCT00678886|142837540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.538|TWO_SIDED|95.0|-0.15|0.49|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 6||0.49|-0.15|0.538
71662143|NCT00678886|142837540|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.538|TWO_SIDED|95.0|-0.19|0.36|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Week 12||0.36|-0.19|0.538
71662144|NCT00678886|142837549|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.12||||0.54|TWO_SIDED|95.0|-0.88|3.11|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Week 12||3.11|-0.88|0.540
71662145|NCT00678886|142837549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.83||||0.546|TWO_SIDED|95.0|-1.89|3.56|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 6||3.56|-1.89|0.546
71662146|NCT00678886|142837549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.462|TWO_SIDED|95.0|-1.56|3.42|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 12||3.42|-1.56|0.462
71662147|NCT00678886|142837550|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.957
71662148|NCT00678886|142837550|SUPERIORITY_OR_OTHER|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.957
71662149|NCT00678886|142837551|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6||||0.653
71662150|NCT00678886|142837551|SUPERIORITY_OR_OTHER|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12||||0.653
71662151|NCT00206323|142837557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0259|||||||t-test, 2 sided|||"Primary variable change of TTS/YGTSS at the BSL to Day 70. Changes of YGTSS compared using analysis of covariance with score at day 1 as a covariate. Groups compared for incidence of AE's and of AESI based on Fisher's Exact Test. All tests were two-sided at the 5% level of significance.~The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)"||||0.0259
71662152|NCT01943994|142837572|SUPERIORITY||Odds Ratio (OR)|6.12||||0.003|TWO_SIDED|95.0|1.99|23.26|||Regression, Logistic|||||23.26|1.99|0.003
71662153|NCT02304458|142837622|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|3.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is 3 mg/kg Nivolumab|||||
71662154|NCT02288182|142837636|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.||||0.001
71662155|NCT02823652|142837646|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71890852|NCT03093402|143303439|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.408|TWO_SIDED|95.0|-0.4|0.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.26|-0.40|0.408
71896181|NCT02495077|143314343|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.51|TWO_SIDED|95.0|-6.22|3.1|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.10|-6.22|0.510
71740774|NCT03058692|142993487|OTHER|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.26
71740775|NCT03058692|142993488|OTHER|||||||0.72||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.72
71740776|NCT03058692|142993488|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
71740777|NCT03058692|142993489|OTHER|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.31
71740778|NCT03058692|142993489|OTHER|||||||0.22||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.22
71775980|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.447|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.447
71662156|NCT02823652|142837647|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71662157|NCT02823652|142837648|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|||||||0.312
71662158|NCT02823652|142837649|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71662159|NCT00620659|142837672|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.615
71662160|NCT00620659|142837673|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-4.11|||||TWO_SIDED|90.0|-5.92|-2.3||||||||-2.30|-5.92|
71662161|NCT00620659|142837674|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-3.8|||||TWO_SIDED|90.0|-5.23|-2.38||||||||-2.38|-5.23|
71662162|NCT00620659|142837675|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.079
71662163|NCT00620659|142837676|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|The mixed model included terms for period and treatment.||||||0.003
71662164|NCT02056392|142837687|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
71662165|NCT02056392|142837687|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|6.1|||||TWO_SIDED|90.0|4.4|7.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||7.7|4.4|
71662166|NCT02056392|142837688|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|90.0|-2.0|1.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.3|-2.0|
71662167|NCT02056392|142837688|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.2|||||TWO_SIDED|90.0|7.6|10.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.8|7.6|
71662168|NCT02056392|142837689|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|90.0|-0.7|2.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.5|-0.7|
71662169|NCT02056392|142837689|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.9|||||TWO_SIDED|90.0|8.3|11.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.5|8.3|
71662170|NCT02056392|142837690|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|90.0|-1.2|2.0|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||2.0|-1.2|
71775981|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.27|0.059
71775982|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.196|TWO_SIDED|95.0|-0.23|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.23|0.196
71775983|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
71775984|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.845|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.845
71775985|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
71775986|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
71775987|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
71775988|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
71662171|NCT02056392|142837690|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.1|||||TWO_SIDED|90.0|8.5|11.8|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||11.8|8.5|
71775989|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
71775990|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
71662172|NCT02056392|142837691|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|90.0|-1.8|1.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||1.5|-1.8|
71662173|NCT02056392|142837691|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|11.9||||||90.0|10.3|13.6|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||13.6|10.3|
71662174|NCT02056392|142837692|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.5|||||TWO_SIDED|90.0|-3.1|0.2|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.2|-3.1|
71662175|NCT02056392|142837692|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.8|||||TWO_SIDED|90.0|9.2|12.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||12.5|9.2|
71662176|NCT02056392|142837693|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-3.4|-0.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.1|-3.4|
71662177|NCT02056392|142837693|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.8|||||TWO_SIDED|90.0|7.1|10.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.4|7.1|
71662178|NCT02056392|142837694|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-2.9|0.4|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||0.4|-2.9|
71662179|NCT02056392|142837694|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.9|||||TWO_SIDED|90.0|7.2|10.5|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||10.5|7.2|
71740779|NCT03058692|142993490|OTHER|||||||0.16||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.16
71740780|NCT03058692|142993490|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
71740781|NCT03058692|142993491|OTHER|||||||0.67||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.67
71775991|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.011|TWO_SIDED|95.0|-0.28|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.28|0.011
71775992|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.36|<0.001
71775993|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.43|-0.18|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.18|-0.43|<0.001
71775994|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.36|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.36|<0.001
71662180|NCT02056392|142837695|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-4.7|||||TWO_SIDED|90.0|-6.4|-3.1|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-3.1|-6.4|
71662181|NCT02056392|142837695|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|7.6|||||TWO_SIDED|90.0|6.0|9.3|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||9.3|6.0|
71775995|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.043|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.043
71775996|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.31|0.007
71775997|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.12|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.38|<0.001
71775998|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.36|<0.001
71775999|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.074|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.074
71776000|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
71776001|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.10|-0.37|<0.001
71776002|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.49|-0.23|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.23|-0.49|<0.001
71662182|NCT02056392|142837696|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|90.0|-4.1|-0.9|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||-0.9|-4.1|
71776003|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.236|TWO_SIDED|95.0|-0.21|0.05|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.21|0.236
71776004|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.112|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.112
71776005|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.38|<0.001
71776006|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.12|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.12|-0.39|<0.001
71776007|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.059|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.059
71776008|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.33|0.003
71776009|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.001|TWO_SIDED|95.0|-0.36|-0.09|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.09|-0.36|0.001
71776010|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.51|-0.24|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.51|<0.001
71776011|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
71776012|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.28|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.28|0.038
71776013|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.33|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.33|0.007
71662183|NCT02056392|142837696|NON_INFERIORITY_OR_EQUIVALENCE|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|4.0|||||TWO_SIDED|90.0|2.4|5.7|||Mixed Models Analysis|||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.||5.7|2.4|
71833899|NCT04714320|143171966|SUPERIORITY||||||=|0.764||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 106||||=0.764
71833900|NCT04714320|143171966|SUPERIORITY||||||=|0.527||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.527
71833901|NCT04714320|143171966|SUPERIORITY||||||=|0.639||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 120||||=0.639
71833902|NCT04714320|143171966|SUPERIORITY||||||=|0.744||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.744
71833903|NCT04714320|143171966|SUPERIORITY||||||=|0.539||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 148||||=0.539
71833904|NCT04714320|143171966|SUPERIORITY||||||=|0.417||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.417
71833905|NCT04714320|143171966|SUPERIORITY||||||=|0.466||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office DBP ≤ 80 mmHg at Day 169||||=0.466
71833906|NCT04714320|143171966|SUPERIORITY||||||=|0.38||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.380
71833907|NCT04714320|143171966|SUPERIORITY||||||=|0.73||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 8||||=0.730
71833908|NCT04714320|143171966|SUPERIORITY||||||=|0.595||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.595
71833909|NCT04714320|143171966|SUPERIORITY||||||=|0.279||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 15||||=0.279
71833910|NCT04714320|143171966|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.196
71833911|NCT04714320|143171966|SUPERIORITY||||||=|0.728||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 22||||=0.728
71833912|NCT04714320|143171966|SUPERIORITY||||||=|0.453||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.453
71833913|NCT04714320|143171966|SUPERIORITY||||||=|0.681||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 29||||=0.681
71833914|NCT04714320|143171966|SUPERIORITY||||||=|0.863||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.863
71662184|NCT03867097|142837730|SUPERIORITY||LS mean difference in change|-0.77|STANDARD_ERROR_OF_MEAN|4.047||0.8498|TWO_SIDED|95.0|-9.04|7.49|||ANCOVA||The Shapiro-Wilk normality test of residuals indicated that the data did not have a normal distribution (p-value 0.0108).|"Treatment comparison of change versus placebo. LS mean difference in change. When a subject had no RP attacks in the past 24 hours, the frequency was considered as zero for that day.~The LS means, SEs, CIs, and p-values came from an ANCOVA model with randomized treatment group and use of phosphodiesterase inhibitors at screening (yes, no) as factors and baseline as a covariate."||7.49|-9.04|0.8498
71662185|NCT03867097|142837730|SUPERIORITY||Median Difference (Final Values)|-0.24||||0.9729|TWO_SIDED|95.0|-9.97|9.32|||Wilcoxon (Mann-Whitney)|||"Change in the Weekly Frequency of Symptomatic Raynaud's Phenomenon Attacks From Baseline to the Double-Blind Endpoint Using Nonparametric Analysis - Modified Intent-to-Treat Population.~Treatment comparison of change versus placebo."||9.32|-9.97|0.9729
71662186|NCT01372774|142837731|SUPERIORITY||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.63|0.35|<0.0001
71662187|NCT01372774|142837732|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7|TWO_SIDED|95.0|0.76|1.5|||Log Rank|||||1.50|0.76|0.70
71662188|NCT01372774|142837733|SUPERIORITY|||||||0.00068||||||Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Gray's K-sample|||||||0.00068
71662189|NCT01372774|142837735|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71662190|NCT02022748|142837737|OTHER||Ratio of Geometric Least Square Means|151.13|||||TWO_SIDED|90.0|112.03|203.86|||||Treatment H is the reference treatment.|||203.86|112.03|
71662191|NCT02022748|142837737|OTHER||Ratio of Geometric Least Square Means|161.38|||||TWO_SIDED|90.0|122.52|212.58|||||Treatment H is the reference treatment.|||212.58|122.52|
71662192|NCT02022748|142837737|OTHER||Ratio of Geometric Least Square Means|90.1|||||TWO_SIDED|90.0|78.07|103.98|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||103.98|78.07|
71662193|NCT02022748|142837738|OTHER||Ratio of Geometric Least Square Means|117.09|||||TWO_SIDED|90.0|84.51|162.22|||||Treatment H is the reference treatment.|||162.22|84.51|
71662194|NCT02022748|142837738|OTHER||Ratio of Geometric Least Square Means|136.27|||||TWO_SIDED|90.0|95.38|194.7|||||Treatment H is the reference treatment.|||194.70|95.38|
71662195|NCT02022748|142837738|OTHER||Ratio of Geometric Least Square Means|82.29|||||TWO_SIDED|90.0|68.43|98.96|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||98.96|68.43|
71662196|NCT02022748|142837739|OTHER||Ratio of Geometric Least Square Means|137.75|||||TWO_SIDED|90.0|105.7|179.52|||||Treatment H is the reference treatment.|||179.52|105.70|
71662197|NCT02022748|142837739|OTHER||Ratio of Geometric Least Square Means|148.76|||||TWO_SIDED|90.0|115.07|192.32|||||Treatment H is the reference treatment.|||192.32|115.07|
71776014|NCT00809354|143051257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.42|<0.001
71662198|NCT02022748|142837739|OTHER||Ratio of Geometric Least Square Means|90.35|||||TWO_SIDED|90.0|77.55|105.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||105.27|77.55|
71662199|NCT02022748|142837740|OTHER||Ratio of Geometric Least Square Means|112.73|||||TWO_SIDED|90.0|88.61|143.42|||||Treatment H is the reference treatment.|||143.42|88.61|
71662200|NCT02022748|142837740|OTHER||Ratio of Geometric Least Square Means|114.37|||||TWO_SIDED|90.0|91.19|143.45|||||Treatment H is the reference treatment.|||143.45|91.19|
71662201|NCT02022748|142837740|OTHER||Ratio of Geometric Least Square Means|93.13|||||TWO_SIDED|90.0|80.31|108.0|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.|||108.00|80.31|
71662202|NCT02022748|142837741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|90.0|-0.97|0.75|||||Treatment A - Treatment H.|||0.75|-0.97|
71662203|NCT02022748|142837741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|90.0|-0.96|1.52|||||Treatment B - Treatment H.|||1.52|-0.96|
71662204|NCT02022748|142837741|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.36|||||TWO_SIDED|90.0|-1.73|1.02|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||1.02|-1.73|
71662205|NCT02022748|142837742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||||TWO_SIDED|90.0|-2.62|0.48|||||Treatment A - Treatment H.|||0.48|-2.62|
71662206|NCT02022748|142837742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|||||TWO_SIDED|90.0|-2.46|0.37|||||Treatment B - Treatment H.|||0.37|-2.46|
71662207|NCT02022748|142837742|SUPERIORITY_OR_OTHER||Difference of Least Square Means|-0.5|||||TWO_SIDED|90.0|-1.27|0.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.|||0.27|-1.27|
71662208|NCT01555671|142837761|OTHER||Mean Difference (Net)|30.0||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.029
71662209|NCT00000378|142837768|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||actual calculation|Regression, Logistic|||logistic regression and mixed effects model||||<0.05
71662210|NCT00324649|142837782|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0014
71662211|NCT00324649|142837783|SUPERIORITY_OR_OTHER|||||||0.9713||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9713
71662212|NCT00324649|142837784|SUPERIORITY_OR_OTHER|||||||0.9725||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9725
71662213|NCT00324649|142837785|SUPERIORITY_OR_OTHER|||||||0.0078||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0078
71662214|NCT00324649|142837786|SUPERIORITY_OR_OTHER|||||||0.6984||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).||||0.6984
71662215|NCT00324649|142837787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.1165||95.0|-0.9|29.4||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.|The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.|"Null Hypothesis: treatment is not associated with the observed virologic response.~Alternative Hypothesis: treatment is associated with the observed virologic response."||29.4|-0.9|0.1165
71662216|NCT00324649|142837790|SUPERIORITY_OR_OTHER|||||||0.0789||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0789
71662217|NCT00324649|142837791|SUPERIORITY_OR_OTHER|||||||0.9633||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9633
71662218|NCT00324649|142837792|SUPERIORITY_OR_OTHER|||||||0.9686||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.9686
71662219|NCT00324649|142837793|SUPERIORITY_OR_OTHER|||||||0.6638||95.0||||No adjustments for multiple comparisons were performed.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.6638
71662220|NCT00324649|142837794|SUPERIORITY_OR_OTHER|||||||0.2907||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.2907
71662221|NCT00324649|142837795|SUPERIORITY_OR_OTHER|||||||0.0072||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0072
71662222|NCT00324649|142837796|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.0006
71662223|NCT00324649|142837797|SUPERIORITY_OR_OTHER|||||||0.1785||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.1785
71662224|NCT01988129|142837800|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'sick' days||||0.66
71740782|NCT03058692|142993491|OTHER|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.48
71740783|NCT03058692|142993492|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
71740784|NCT03058692|142993492|OTHER|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.62
71662225|NCT01988129|142837800|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||t-test, 2 sided|||Analysis for 'disability/injury' days||||0.033
71662226|NCT01988129|142837800|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)||Mixed model analysis was conducted for 'disability/injury' days||||0.003
71662227|NCT01988129|142837801|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||t-test, 2 sided|||||||0.87
71662228|NCT01988129|142837802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.31|TWO_SIDED|95.0|0.6|0.98|||t-test, 2 sided||The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).|||0.98|0.60|0.31
71662229|NCT01988129|142837803|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time points||||0.22
71662230|NCT01988129|142837804|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||paired t-test|||||||0.65
71662231|NCT01988129|142837805|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||paired t-test|||||||0.71
71740785|NCT03058692|142993493|OTHER|||||||0.0093||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.0093
71740786|NCT03058692|142993493|OTHER|||||||0.51||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.51
71740787|NCT03058692|142993494|OTHER|||||||0.54||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.54
71740788|NCT03058692|142993494|OTHER|||||||0.43||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.43
71740789|NCT03058692|142993495|OTHER|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.44
71740790|NCT03058692|142993495|OTHER|||||||0.014||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.014
71740791|NCT03058692|142993496|OTHER||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||<0.001
71776015|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.469|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.469
71776016|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.06||0.387|TWO_SIDED|95.0|-0.18|0.07|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.18|0.387
71776017|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.887|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.13|-0.11|0.887
71662232|NCT01988129|142837807|SUPERIORITY_OR_OTHER||Percentage of firefighters screened|41.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group||||
71662233|NCT01988129|142837807|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|31.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group||||
71662234|NCT01988129|142837807|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|7.7|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of insomnia; there is no comparison group||||
71662235|NCT01988129|142837807|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|3.5|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group||||
71662236|NCT01988129|142837807|SUPERIORITY_OR_OTHER||Percentage of firefighters screene|9.3|||||TWO_SIDED|||||||||This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group||||
71662237|NCT01988129|142837808|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||paired t-test|||||||0.31
71662238|NCT01988129|142837809|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Paired t-test, 2-sided|||Sleeping while stopped in traffic||||0.16
71662239|NCT01988129|142837810|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Paired t-test, 2-sided|||||||0.46
71662240|NCT04713553|142837812|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% confidence interval (CI) for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|1.01|||||TWO_SIDED|95.0|0.91|1.13|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.13|0.91|
71662241|NCT04713553|142837812|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.04|0.83|
71662242|NCT04713553|142837812|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.92|||||TWO_SIDED|95.0|0.82|1.03|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.03|0.82|
71662243|NCT04713553|142837813|EQUIVALENCE|Equivalence was to be achieved if the 2-sided 95% CI for GMR falls within the interval (0.67, 1.5).|Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.84|1.07|||||GMRs and corresponding 2-sided 95% CIs were calculated by exponentiating difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group.|||1.07|0.84|
71662244|NCT04713553|142837814|NON_INFERIORITY|Noninferiority of the 20 mcg dose to the corresponding 30 mcg dose was said to be achieved if the lower limit of the 2-sided 95% CI for the GMR is \>0.67.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||GMRs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model with terms of age and vaccine group|||1.02|0.84|
71662245|NCT01853930|142837866|SUPERIORITY|The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option.||||||0.876|||||||t-test, 2 sided|t= -0.157 df= 30||||||0.876
71662246|NCT04540406|142837872|OTHER|We employed covariate-adjusted Principal Coordinates Analysis and a subject-stratified PERMANOVA test to assess the overall gut microbiota structural change. These tests are generally neither superiority, non-inferiority, nor equivalence tests. Instead, they are used to detect and evaluate overall differences in the microbial community structure between groups or conditions.||||||||||||||||PCoA (Principal Coordinates Analysis) + PERMANOVA (Permutational Multivariate Analysis of Variance) are exploratory multivariate techniques commonly used in microbiome research to assess and visualize differences in community composition. The null hypothesis for PERMANOVA is that there are no differences in the centroids (multivariate means) of the groups being compared. The microbial communities in different groups or conditions are not significantly different from each other.|To assess the overall structural changes in gut microbiota, we employed covariate-adjusted Principal Coordinates Analysis (PCoA) and a subject-stratified PERMANOVA test. PCoA, an exploratory multivariate technique, helps visualize and interpret patterns in complex microbiome data by reducing dimensionality, with the first principal coordinate (PC1) capturing the largest variation among samples. PERMANOVA, which does not rely on standard parametric assumptions, was used to determine if there are statistically significant differences in the overall composition of microbial communities between groups based on a chosen distance metric. Our analysis aimed to explore whether microbial community compositions differed significantly between Day 0 and Day 28 within the Treatment group, accounting for inter-individual variability. Similarly, we investigated if such differences existed over the same time points in the Control group. The unit of measure was distance metrics.|||
71662247|NCT04091659|142837889|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|-0.18||||0.65|TWO_SIDED|95.0|-0.85|0.49|||SEM||||The control group, standard education was the reference for this model.|0.49|-0.85|0.65
71662248|NCT04091659|142837890|EQUIVALENCE|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|0.26||||0.02|TWO_SIDED|95.0|0.02|0.5|||SEM||The control group, standard education, was the reference|||0.50|0.02|0.02
71662249|NCT01081834|142837896|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.088|-0.729|||ANCOVA|||||-0.729|-1.088|<0.001
71662250|NCT01081834|142837896|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.091|<|0.001|TWO_SIDED|95.0|-1.342|-0.985|||ANCOVA|||||-0.985|-1.342|<0.001
71662251|NCT01081834|142837898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|3.1|9.23|||Regression, Logistic|||||9.23|3.10|<0.001
71662252|NCT01081834|142837898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.61|||<|0.001|TWO_SIDED|95.0|8.14|26.25|||Regression, Logistic|||||26.25|8.14|<0.001
71662253|NCT01081834|142837899|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.5|STANDARD_ERROR_OF_MEAN|3.42|<|0.001|TWO_SIDED|95.0|-42.22|-28.78|||ANCOVA|||||-28.78|-42.22|<0.001
71662254|NCT01081834|142837899|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-43.4|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-50.06|-36.69|||ANCOVA|||||-36.69|-50.06|<0.001
71662255|NCT01081834|142837900|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|5.629|<|0.001|TWO_SIDED|95.0|-59.12|-36.99|||ANCOVA|||||-36.99|-59.12|<0.001
71662256|NCT01081834|142837900|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-64.0|STANDARD_ERROR_OF_MEAN|5.616|<|0.001|TWO_SIDED|95.0|-75.02|-52.94|||ANCOVA|||||-52.94|-75.02|<0.001
71662257|NCT01081834|142837901|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.6|||ANCOVA|||||-1.6|-2.9|<0.001
71890853|NCT03093402|143303439|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.408|TWO_SIDED|95.0|-0.5|0.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physician's Global Assessment (PGA) Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline PGA score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -0.43 (-0.70, -0.15).|Each active JBT-101 cohort is compared to placebo.||0.16|-0.50|0.408
71896182|NCT02495077|143314343|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.43|TWO_SIDED|95.0|-6.45|2.76|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||2.76|-6.45|0.430
71662258|NCT01081834|142837901|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-4.0|-2.6|||ANCOVA|||||-2.6|-4.0|<0.001
71662259|NCT01081834|142837902|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|1.093|<|0.001|TWO_SIDED|95.0|-5.86|-1.568|||ANCOVA|||||-1.568|-5.860|<0.001
71662260|NCT01081834|142837902|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.088|<|0.001|TWO_SIDED|95.0|-7.556|-3.28|||ANCOVA|||||-3.280|-7.556|<0.001
71662261|NCT01081834|142837903|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|4.8||0.267|TWO_SIDED|95.0|-14.8|4.1|||ANCOVA|||||4.1|-14.8|0.267
71662262|NCT01081834|142837903|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.8||0.034|TWO_SIDED|95.0|-19.6|-0.8|||ANCOVA|||||-0.8|-19.6|0.034
71662263|NCT01081834|142837904|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.9|10.6|||ANCOVA|||||10.6|2.9|<0.001
71776018|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.06||0.084|TWO_SIDED|95.0|-0.01|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.01|0.084
71776019|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.018
71776020|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.783|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.783
71776021|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.762|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.15|-0.11|0.762
71776022|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|0.03|0.29|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.29|0.03|0.017
71776023|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.091|TWO_SIDED|95.0|-0.23|0.02|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.23|0.091
71662264|NCT01081834|142837904|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.9||0.002|TWO_SIDED|95.0|2.2|9.9|||ANCOVA|||||9.9|2.2|0.002
71662265|NCT03149445|142837941|SUPERIORITY||LS Mean Difference|-5.4||||0.1045|TWO_SIDED|95.0|-12.3|1.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||1.5|-12.3|0.1045
71662266|NCT03149445|142837941|SUPERIORITY||LS Mean Difference|0.7||||0.7422|TWO_SIDED|95.0|-4.0|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-4.0|0.7422
71662267|NCT03149445|142837941|SUPERIORITY||LS Mean Difference|5.6||||0.046|TWO_SIDED|95.0|0.1|11.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.0|0.1|0.0460
71662268|NCT03149445|142837941|SUPERIORITY||LS Mean Difference|4.3||||0.3847|TWO_SIDED|95.0|-9.2|17.8||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||17.8|-9.2|0.3847
71662269|NCT03149445|142837942|SUPERIORITY||LS Mean Difference|-6.2||||0.1326|TWO_SIDED|95.0|-14.9|2.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||2.5|-14.9|0.1326
71662270|NCT03149445|142837942|SUPERIORITY||LS Mean Difference|1.2||||0.5148|TWO_SIDED|95.0|-2.9|5.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||5.3|-2.9|0.5148
71662271|NCT03149445|142837942|SUPERIORITY||LS Mean Difference|4.5||||0.0605|TWO_SIDED|95.0|-0.3|9.4||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.4|-0.3|0.0605
71662272|NCT03149445|142837942|SUPERIORITY||LS Mean Difference|2.6||||0.5198|TWO_SIDED|95.0|-8.8|14.0||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||14.0|-8.8|0.5198
71662273|NCT03149445|142837943|SUPERIORITY||LS Mean Difference|-8.1||||0.0058|TWO_SIDED|95.0|-12.5|-3.6||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||-3.6|-12.5|0.0058
71662274|NCT03149445|142837943|SUPERIORITY||LS Mean Difference|2.1||||0.5142|TWO_SIDED|95.0|-5.3|9.5||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||9.5|-5.3|0.5142
71662275|NCT03149445|142837943|SUPERIORITY||LS Mean Difference|3.1||||0.3794|TWO_SIDED|95.0|-5.1|11.3||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||11.3|-5.1|0.3794
71776024|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.009|TWO_SIDED|95.0|-0.29|-0.04|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.04|-0.29|0.009
71662276|NCT03149445|142837943|SUPERIORITY||LS Mean Difference|1.0||||0.685|TWO_SIDED|95.0|-6.1|8.1||P-value from an ANCOVA with treatment as factor and baseline as covariate|ANCOVA|||||8.1|-6.1|0.6850
71662277|NCT06017479|142837965|OTHER|"Chi-square test as the study used chi-square analysis to compare the incidence of UTIs between the groups (p = 0.660) For this non-inferiority analysis, the study demonstrated that the odds ratio (OR) between the two groups was 0.8 (95% CI: 0.4-1.95), indicating no significant difference. Further details are provided in the study's discussion section."|Odds Ratio (OR)|0.8|STANDARD_DEVIATION|18.125||0.66|TWO_SIDED|95.0|0.4|1.95||The p-value was not adjusted for multiple comparisons as there were no multiple outcome measures being compared in this analysis. The significance threshold (alpha) was set at 0.05.|Chi-squared||"The standard deviations (SD) for the groups are as follows:~For the group receiving 3g fosfomycin: 19.08 For the group receiving 500mg levofloxacin: 17.17"|This randomized controlled trial compared the incidence of UTI between two groups: patients receiving a single dose of 500 mg levofloxacin and patients receiving a single dose of 3 g fosfomycin one hour before a urodynamic study. The null hypothesis is that there is no significant difference in UTI incidence between the two groups. The power calculation was based on a sample size of 126 patients.|A chi-square test was performed to compare the incidence of UTIs between the two groups: patients receiving a single dose of 500 mg levofloxacin and those receiving a single dose of 3 g fosfomycin, both administered one hour before the urodynamic study (UDS). The result showed no statistically significant difference between the two groups (p = 0.660). An odds ratio was also calculated (OR = 0.8, 95% CI: 0.4-1.95), indicating a slightly lower likelihood of UTI in the fosfomycin group, but the difference was not significant.|1.95|0.4|0.660
71662278|NCT04058067|142837966|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.013|TWO_SIDED|95.0|-3.7|1.1|||ANOVA|||||1.1|-3.7|0.013
71662279|NCT04058067|142837967|SUPERIORITY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.15||0.035|TWO_SIDED|95.0|-4.2|0.4|||ANOVA|||||0.4|-4.2|0.035
71662280|NCT04058067|142837969|SUPERIORITY||Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-3.0|0.8|||ANOVA|||||0.8|-3.0|
71662281|NCT04058067|142837970|SUPERIORITY||Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-4.0|0.2|||ANOVA|||||0.2|-4.0|
71662282|NCT04058067|142837971|SUPERIORITY||Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|95.0|-4.3|0.2|||ANOVA|||||0.2|-4.3|
71662283|NCT04058067|142837974|SUPERIORITY||DIfference|-3.0|||||TWO_SIDED|95.0|-13.7|6.7|||Regression, Logistic|||Proportion of subjects with ≥5 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.7|-13.7|
71662284|NCT04058067|142837974|SUPERIORITY||Difference|-2.6|||||TWO_SIDED|95.0|-14.7|9.4|||Regression, Logistic|||Proportion of subjects with ≥10 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||9.4|-14.7|
71662285|NCT04058067|142837974|SUPERIORITY||Difference|-3.8|||||TWO_SIDED|95.0|-15.5|6.9|||Regression, Logistic|||Proportion of subjects with ≥15 letters gain from baseline or reached BCVA of ≥84 letters at Week 52||6.9|-15.5|
71776025|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.835|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.835
71776026|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.06||0.463|TWO_SIDED|95.0|-0.08|0.17|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.17|-0.08|0.463
71662286|NCT04058067|142837978|SUPERIORITY||DIfference|0.1|||||TWO_SIDED|95.0|-4.2|4.4|||Regression, Logistic|||Proportion of subjects with ≥5 letters loss from baseline at Week 52||4.4|-4.2|
71662287|NCT04058067|142837978|SUPERIORITY||Difference|0.8|||||TWO_SIDED|95.0|-1.6|3.8|||Regression, Logistic|||Proportion of subjects with ≥10 letters loss from baseline at Week 52||3.8|-1.6|
71662288|NCT04058067|142837978|SUPERIORITY||Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.3|||Regression, Logistic|||Proportion of subjects with ≥15 letters loss from baseline at Week 52||2.3|-2.2|
71662289|NCT04058067|142837979|OTHER|Descriptive, Week 4|Difference - %|0.4|||||TWO_SIDED|95.0|-7.9|8.6|||Clopper-Pearson exact method|||Week 4||8.6|-7.9|
71662290|NCT04058067|142837979|OTHER|Descriptive, Week 6|Difference - %|-5.1|||||TWO_SIDED|95.0|-14.3|2.9|||Clopper-Pearson exact method|||Week 6||2.9|-14.3|
71662291|NCT04058067|142837979|OTHER|Descriptive, Week 8|Difference - %|-4.0||||||95.0|-13.3|4.4|||Clopper-Pearson exact method|||Week 8||4.4|-13.3|
71662292|NCT04058067|142837979|OTHER|Descriptive, Week 12|Difference - %|-7.0|||||TWO_SIDED|95.0|-16.4|2.3|||Clopper-Pearson exact method|||Week 12||2.3|-16.4|
71662293|NCT04058067|142837979|OTHER|Descriptive, Week 16|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.2|0.0|||Clopper-Pearson exact method|||Week 16||-0.0|-19.2|
71662294|NCT04058067|142837979|OTHER|Descriptive, Week 18|Difference - %|-9.8|||||TWO_SIDED|95.0|-19.0|0.0|||Clopper-Pearson exact method|||Week 18||-0.0|-19.0|
71776027|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.713|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.16|0.713
71776028|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.267|TWO_SIDED|95.0|-0.21|0.06|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.21|0.267
71662295|NCT04058067|142837979|OTHER|Descriptive, Week 20|Difference - %|-5.7|||||TWO_SIDED|95.0|-15.8|3.9|||Clopper-Pearson exact method|||Week 20||3.9|-15.8|
71662296|NCT04058067|142837979|OTHER|Descriptive, Week 24|Difference - %|-13.4|||||TWO_SIDED|95.0|-23.9|-3.1|||Clopper-Pearson exact method|||Week 24||-3.1|-23.9|
71662297|NCT04058067|142837979|OTHER|Descriptive, Week 28|Difference - %|-12.4|||||TWO_SIDED|95.0|-22.0|-2.1|||Clopper-Pearson exact method|||Week 28||-2.1|-22.0|
71662298|NCT04058067|142837979|OTHER|Descriptive, Week 32|Difference - %|-15.4|||||TWO_SIDED|95.0|-26.0|-4.8|||Clopper-Pearson exact method|||Week 32||-4.8|-26.0|
71662299|NCT04058067|142837979|OTHER|Descriptive, Week 36|Difference - %|-18.8|||||TWO_SIDED|95.0|-29.5|-8.9|||Clopper-Pearson exact method.|||Week 36||-8.9|-29.5|
71662300|NCT04058067|142837979|OTHER|Descriptive, Week 40|Difference - %|-18.4|||||TWO_SIDED|95.0|-28.7|-8.6|||Clopper-Pearson exact method|||Week 40||-8.6|-28.7|
71776029|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.552|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.552
71662301|NCT04058067|142837979|OTHER|Descriptive, Week 44|Difference - %|-14.9|||||TWO_SIDED|95.0|-25.6|-4.4|||Clopper-Pearson exact method|||Week 44||-4.4|-25.6|
71776030|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.885|TWO_SIDED|95.0|-0.12|0.14|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.14|-0.12|0.885
71833915|NCT04714320|143171966|SUPERIORITY||||||=|0.837||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 36||||=0.837
71662302|NCT04058067|142837979|OTHER|Descriptive, Week 48|Difference - %|-13.3|||||TWO_SIDED|95.0|-23.6|-3.4|||Clopper-Pearson exact method|||Week 48||-3.4|-23.6|
71662303|NCT04058067|142837979|OTHER|Descriptive, Week 52|Difference - %|-12.6|||||TWO_SIDED|95.0|-23.5|-2.9|||Clopper-Pearson exact method|||Week 52||-2.9|-23.5|
71662304|NCT04058067|142837980|SUPERIORITY||Difference|-1.3|||||TWO_SIDED|95.0|-13.6|11.2|||Clopper-Pearson exact method|||||11.2|-13.6|
71662305|NCT04058067|142837982|SUPERIORITY||Difference|-10.2|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-37.3|17.0|||ANOVA|||||17.0|-37.3|
71662306|NCT04058067|142837983|SUPERIORITY||Difference|-2.5|STANDARD_ERROR_OF_MEAN|12.34|||TWO_SIDED|95.0|-26.8|21.9|||ANOVA|||||21.9|-26.8|
71662307|NCT04058067|142837984|SUPERIORITY||Difference|-8.5|STANDARD_ERROR_OF_MEAN|11.03|||TWO_SIDED|95.0|-30.3|13.2|||ANOVA|||||13.2|-30.3|
71662308|NCT04058067|142837985|SUPERIORITY||Difference - %|5.3|||||TWO_SIDED|95.0|-3.3|13.5|||Clopper-Pearson exact method|||Week 4||13.5|-3.3|
71662309|NCT04058067|142837985|SUPERIORITY||Difference - %|10.8|||||TWO_SIDED|95.0|1.4|20.6|||Clopper-Pearson exact method|||Week 6||20.6|1.4|
71662310|NCT04058067|142837985|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|3.9|25.3|||Clopper-Pearson exact method|||Week 8||25.3|3.9|
71662311|NCT04058067|142837985|SUPERIORITY||Difference - %|14.1|||||TWO_SIDED|95.0|2.8|24.9|||Clopper-Pearson exact method||Proportion estimates (%) = 39.3|Week 12||24.9|2.8|
71662312|NCT04058067|142837985|SUPERIORITY||Difference - %|16.8||||||95.0|5.1|28.6|||Clopper-Pearson exact method|||Week 16||28.6|5.1|
71662313|NCT04058067|142837985|SUPERIORITY||Difference - %|15.4|||||TWO_SIDED|95.0|3.1|26.6|||Clopper-Pearson exact method|||Week 18||26.6|3.1|
71662314|NCT04058067|142837985|SUPERIORITY||Difference - %|15.7|||||TWO_SIDED|95.0|3.5|27.1|||Clopper-Pearson exact method|||Week 20||27.1|3.5|
71662315|NCT04058067|142837985|SUPERIORITY||Difference - %|19.1|||||TWO_SIDED|95.0|7.2|30.2|||Clopper-Pearson exact method|||Week 24||30.2|7.2|
71662316|NCT04058067|142837985|SUPERIORITY||Difference - %|16.4|||||TWO_SIDED|95.0|4.9|27.9|||Clopper-Pearson exact method|||Week 28||27.9|4.9|
71662317|NCT04058067|142837985|SUPERIORITY||Difference - %|12.1|||||TWO_SIDED|95.0|0.4|24.4|||Clopper-Pearson exact method|||Week 32||24.4|0.4|
71662318|NCT04058067|142837985|SUPERIORITY||Difference - %|6.0|||||TWO_SIDED|95.0|-5.9|18.0|||Clopper-Pearson exact method|||Week 36||18.0|-5.9|
71662319|NCT04058067|142837985|SUPERIORITY||Difference - %|15.2|||||TWO_SIDED|95.0|3.3|26.1|||Clopper-Pearson exact method|||Week 40||26.1|3.3|
71662320|NCT04058067|142837985|SUPERIORITY||Difference - %|13.2|||||TWO_SIDED|95.0|1.9|25.7|||Clopper-Pearson exact method|||Week 44||25.7|1.9|
71662321|NCT04058067|142837985|SUPERIORITY||Difference - %|11.9|||||TWO_SIDED|95.0|-0.8|23.6|||Clopper-Pearson exact method|||Week 48||23.6|-0.8|
71662322|NCT04058067|142837985|SUPERIORITY||Difference - %|17.9|||||TWO_SIDED|95.0|5.8|30.5|||Clopper-Pearson exact method|||Week 52||30.5|5.8|
71662323|NCT04058067|142837986|SUPERIORITY||Difference|0.9|||||TWO_SIDED|95.0|0.8|3.6|||Clopper-Pearson exact method|||||3.6|0.8|
71662324|NCT04058067|142837987|SUPERIORITY||Difference|-4.3|||||TWO_SIDED|95.0|-13.2|4.6|||Clopper-Pearson exact method|||||4.6|-13.2|
71662325|NCT04058067|142837988|SUPERIORITY||Difference|1.0|||||TWO_SIDED|95.0|-10.5|12.4|||Clopper-Pearson exact method|||||12.4|-10.5|
71776031|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.47|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.26|0.47
71776032|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.056|TWO_SIDED|95.0|-0.26|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.26|0.056
71662326|NCT04058067|142837993|OTHER|Descriptive, Week 28|Difference - %|-2.4|||||TWO_SIDED|95.0|-13.9|8.8|||Clopper-Pearson exact method|||Week 28||8.8|-13.9|
71662327|NCT04058067|142837993|OTHER|Descriptive, Week 52|Difference - %|-2.8|||||TWO_SIDED|95.0|-14.1|9.0|||Clopper-Pearson exact method|||Week 52||9.0|-14.1|
71662328|NCT04058067|142837995|OTHER|Descriptive, Week 28|Difference - %|4.2|||||TWO_SIDED|95.0|-4.1|12.6|||Clopper-Pearson exact method|||Week 28||12.6|-4.1|
71662329|NCT04058067|142837995|OTHER|Descriptive, Week 52|Difference - %|-0.5|||||TWO_SIDED|95.0|-10.5|9.3|||Clopper-Pearson exact method|||Week 52||9.3|-10.5|
71662330|NCT04058067|142837997|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
71662331|NCT04058067|142837999|OTHER|Descriptive, Week 28|Difference - %|0.8|||||TWO_SIDED|95.0|0.7|2.9|||Clopper-Pearson exact method|||Week 28||2.9|0.7|
71662332|NCT04058067|142838000|SUPERIORITY||LS mean difference|-0.9||||||95.0|-4.1|2.3|||ANCOVA|||Week 28||2.3|-4.1|
71662333|NCT04058067|142838000|SUPERIORITY||LS mean difference|0.1|||||TWO_SIDED|95.0|-3.1|3.3|||ANCOVA|||Week 52||3.3|-3.1|
71662334|NCT05005312|142838017|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|101.96|||||TWO_SIDED|90.0|74.2|140.11|||ANOVA|||||140.11|74.20|
71662335|NCT05005312|142838018|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|99.29|||||TWO_SIDED|90.0|70.81|139.21|||ANOVA|||||139.21|70.81|
71662336|NCT05005312|142838019|OTHER|The ratio and 90% CI were expressed as percentages|Ratio of Adjusted Geometric Means|98.78|||||TWO_SIDED|90.0|70.65|138.12|||ANOVA|||||138.12|70.65|
71662337|NCT02704403|142838035|SUPERIORITY||Mean Difference (Net)|0.043||||0.0659|TWO_SIDED|95.0|-0.003|0.09|||Regression, Logistic|test is 2-sided, alpha=0.01||The null hypothesis was that there was no difference in response rates between the elafibranor and placebo treatment groups. The alternative hypothesis was that there was a difference in the response rates between the elafibranor and placebo treatment groups.||0.090|-0.003|0.0659
71662338|NCT02704403|142838036|SUPERIORITY||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.619|1.457|||||No formal test due to the early termination of the study.|||1.457|0.619|
71662339|NCT01442688|142838055|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.995|1.04|||ANOVA|||||1.04|0.995|
71662340|NCT01442688|142838056|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.94|1.04|||ANOVA|||||1.04|0.940|
71662341|NCT05502081|142838057|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662342|NCT05502081|142838057|SUPERIORITY|||||||0.176|||||||Kruskal-Wallis|||||||0.176
71833916|NCT04714320|143171966|SUPERIORITY||||||=|0.504||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.504
71833917|NCT04714320|143171966|SUPERIORITY||||||=|0.531||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 43||||=0.531
71833918|NCT04714320|143171966|SUPERIORITY||||||=|0.6||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.600
71833919|NCT04714320|143171966|SUPERIORITY||||||=|0.83||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 50||||=0.830
71833920|NCT04714320|143171966|SUPERIORITY||||||=|0.209||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.209
71833921|NCT04714320|143171966|SUPERIORITY||||||=|0.809||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 57||||=0.809
71662343|NCT05502081|142838057|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662344|NCT05502081|142838057|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71833922|NCT04714320|143171966|SUPERIORITY||||||=|0.045||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.045
71833923|NCT04714320|143171966|SUPERIORITY||||||=|0.104||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 64||||=0.104
71833924|NCT04714320|143171966|SUPERIORITY||||||=|0.69||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.690
71662345|NCT05502081|142838058|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
71662346|NCT05502081|142838058|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|||||||0.021
71662347|NCT05502081|142838058|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||0.42
71662348|NCT05502081|142838058|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71662349|NCT05502081|142838059|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71662350|NCT05502081|142838060|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
71662351|NCT05502081|142838060|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71662352|NCT05502081|142838060|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71662353|NCT05502081|142838060|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71662354|NCT05502081|142838061|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662355|NCT05502081|142838061|SUPERIORITY|||||||0.119|||||||Kruskal-Wallis|||||||0.119
71662356|NCT05502081|142838061|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662357|NCT05502081|142838061|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662358|NCT05502081|142838062|SUPERIORITY|||||||0.933|||||||Kruskal-Wallis|||||||0.933
71662359|NCT05502081|142838063|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
71662360|NCT05502081|142838063|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
71662361|NCT05502081|142838063|SUPERIORITY|||||||0.185|||||||Kruskal-Wallis|||||||0.185
71662362|NCT05502081|142838063|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71662363|NCT05502081|142838064|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662364|NCT05502081|142838064|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71662365|NCT05502081|142838064|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662366|NCT05502081|142838064|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662367|NCT05502081|142838065|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662368|NCT05502081|142838065|SUPERIORITY|||||||0.758|||||||Kruskal-Wallis|||||||0.758
71662369|NCT05502081|142838065|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662370|NCT05502081|142838065|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662371|NCT05502081|142838066|SUPERIORITY|||||||0.412|||||||Kruskal-Wallis|||||||0.412
71662372|NCT05502081|142838067|SUPERIORITY|||||||0.106|||||||Kruskal-Wallis|||||||0.106
71662373|NCT05502081|142838068|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71662374|NCT05502081|142838068|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
71662375|NCT05502081|142838068|SUPERIORITY|||||||0.156|||||||Kruskal-Wallis|||||||0.156
71662376|NCT05502081|142838068|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71662377|NCT05502081|142838069|SUPERIORITY|||||||0.219|||||||Kruskal-Wallis|||||||0.219
71662378|NCT05502081|142838070|SUPERIORITY|||||||0.298|||||||Kruskal-Wallis|||||||0.298
71662379|NCT05502081|142838071|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71662380|NCT05502081|142838071|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
71662381|NCT05502081|142838071|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71833925|NCT04714320|143171966|SUPERIORITY||||||=|0.59||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 71||||=0.590
71662382|NCT05502081|142838071|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
71833926|NCT04714320|143171966|SUPERIORITY||||||=|0.538||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.538
71662383|NCT05502081|142838072|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
71662384|NCT05502081|142838072|SUPERIORITY|||||||0.232|||||||Kruskal-Wallis|||||||0.232
71662385|NCT05502081|142838072|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71662386|NCT05502081|142838072|SUPERIORITY|||||||0.054|||||||Kruskal-Wallis|||||||0.054
71662387|NCT05502081|142838073|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71662388|NCT05502081|142838073|SUPERIORITY|||||||0.557|||||||Kruskal-Wallis|||||||0.557
71662389|NCT05502081|142838073|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71662390|NCT05502081|142838073|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71662391|NCT05502081|142838074|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662392|NCT05502081|142838074|SUPERIORITY|||||||0.51|||||||Kruskal-Wallis|||||||0.51
71662393|NCT05502081|142838074|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662394|NCT05502081|142838074|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662395|NCT05502081|142838075|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662396|NCT05502081|142838075|SUPERIORITY|||||||0.891|||||||Kruskal-Wallis|||||||0.891
71662397|NCT05502081|142838075|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662398|NCT05502081|142838075|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662399|NCT05502081|142838076|SUPERIORITY|||||||0.516|||||||Kruskal-Wallis|||||||0.516
71662400|NCT05502081|142838077|SUPERIORITY|||||||0.264|||||||Wilcoxon (Mann-Whitney)|||||||0.264
71662401|NCT05502081|142838078|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662402|NCT05502081|142838078|SUPERIORITY|||||||0.256|||||||Kruskal-Wallis|||||||0.256
71662403|NCT05502081|142838078|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662404|NCT05502081|142838078|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662405|NCT05502081|142838079|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
71662406|NCT05502081|142838079|SUPERIORITY|||||||0.797|||||||Kruskal-Wallis|||||||0.797
71662407|NCT05502081|142838079|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71662408|NCT05502081|142838079|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71662409|NCT05502081|142838080|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71662410|NCT05502081|142838081|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662411|NCT05502081|142838081|SUPERIORITY|||||||0.982|||||||Kruskal-Wallis|||||||0.982
71662412|NCT05502081|142838081|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662413|NCT05502081|142838081|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662414|NCT05502081|142838082|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71662415|NCT05502081|142838082|SUPERIORITY|||||||0.136|||||||Kruskal-Wallis|||||||0.136
71662416|NCT05502081|142838082|SUPERIORITY|||||||0.062|||||||Kruskal-Wallis|||||||0.062
71662417|NCT05502081|142838082|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
71662418|NCT05502081|142838083|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
71662419|NCT05502081|142838084|SUPERIORITY|||||||0.687|||||||Kruskal-Wallis|||||||0.687
71662420|NCT05502081|142838085|SUPERIORITY|||||||0.278|||||||Kruskal-Wallis|||||||0.278
71662421|NCT05502081|142838086|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71662422|NCT05502081|142838087|SUPERIORITY|||||||0.574|||||||Kruskal-Wallis|||||||0.574
71662423|NCT05502081|142838088|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71662424|NCT05502081|142838088|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71662425|NCT05502081|142838088|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||||||0.041
71662426|NCT05502081|142838088|SUPERIORITY|||||||0.616|||||||Kruskal-Wallis|||||||0.616
71662427|NCT05502081|142838089|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71662428|NCT05502081|142838090|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662429|NCT05502081|142838090|SUPERIORITY|||||||0.208|||||||Kruskal-Wallis|||||||0.208
71662430|NCT05502081|142838090|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662431|NCT05502081|142838090|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71662432|NCT05502081|142838091|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||0.088
71662433|NCT05502081|142838092|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71662434|NCT05502081|142838093|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
71662435|NCT05502081|142838093|SUPERIORITY|||||||0.151|||||||Kruskal-Wallis|||||||0.151
71662436|NCT05502081|142838093|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71662437|NCT05502081|142838093|SUPERIORITY|||||||0.035|||||||Kruskal-Wallis|||||||0.035
71662438|NCT05502081|142838094|SUPERIORITY|||||||0.037|||||||Kruskal-Wallis|||||||0.037
71662439|NCT05502081|142838094|SUPERIORITY|||||||0.997|||||||Kruskal-Wallis|||||||0.997
71662440|NCT05502081|142838094|SUPERIORITY|||||||0.016|||||||Kruskal-Wallis|||||||0.016
71662441|NCT05502081|142838094|SUPERIORITY|||||||0.014|||||||Kruskal-Wallis|||||||0.014
71662442|NCT05502081|142838095|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71662443|NCT05502081|142838096|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||||||0.047
71662444|NCT05502081|142838096|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||||||0.04
71662445|NCT05502081|142838096|SUPERIORITY|||||||0.036|||||||Kruskal-Wallis|||||||0.036
71662446|NCT05502081|142838096|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
71662447|NCT05502081|142838097|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71833927|NCT04714320|143171966|SUPERIORITY||||||=|0.407||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 78||||=0.407
71833928|NCT04714320|143171966|SUPERIORITY||||||=|0.398||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.398
71662448|NCT05502081|142838097|SUPERIORITY|||||||0.027|||||||Kruskal-Wallis|||||||0.027
71662449|NCT05502081|142838097|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
71662450|NCT05502081|142838097|SUPERIORITY|||||||0.38|||||||Kruskal-Wallis|||||||0.38
71662451|NCT05502081|142838098|SUPERIORITY|||||||0.814|||||||Kruskal-Wallis|||||||0.814
71662452|NCT05502081|142838099|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71662453|NCT05502081|142838100|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662454|NCT05502081|142838100|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662455|NCT05502081|142838100|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662456|NCT05502081|142838100|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||||||0.971
71662457|NCT05502081|142838101|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71662458|NCT05502081|142838101|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662459|NCT05502081|142838102|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71662460|NCT05502081|142838102|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71662461|NCT05502081|142838102|SUPERIORITY|||||||0.452|||||||Kruskal-Wallis|||||||0.452
71662462|NCT05502081|142838102|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
71662463|NCT05502081|142838103|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71662464|NCT05502081|142838104|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71662465|NCT05502081|142838104|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
71662466|NCT05502081|142838104|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71662467|NCT05502081|142838104|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|||||||0.05
71662468|NCT05502081|142838105|SUPERIORITY|||||||0.423|||||||Kruskal-Wallis|||||||0.423
71662469|NCT05502081|142838106|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||||||0.429
71662470|NCT05502081|142838107|SUPERIORITY|||||||0.089|||||||Kruskal-Wallis|||||||0.089
71662471|NCT05502081|142838108|SUPERIORITY|||||||0.222|||||||Kruskal-Wallis|||||||0.222
71662472|NCT05502081|142838109|SUPERIORITY|||||||0.252|||||||Kruskal-Wallis|||||||0.252
71662473|NCT05502081|142838110|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71662474|NCT05502081|142838111|SUPERIORITY|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71662475|NCT05502081|142838111|SUPERIORITY|||||||0.382|||||||Kruskal-Wallis|||||||0.382
71662476|NCT05502081|142838111|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||||||0.017
71662477|NCT05502081|142838111|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71662478|NCT05502081|142838112|SUPERIORITY|||||||0.457|||||||Kruskal-Wallis|||||||0.457
71662479|NCT05502081|142838113|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71662480|NCT05502081|142838114|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71662481|NCT05502081|142838114|SUPERIORITY|||||||0.605|||||||Kruskal-Wallis|||||||0.605
71662482|NCT05502081|142838114|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71662483|NCT05502081|142838114|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71662484|NCT05502081|142838115|SUPERIORITY|||||||0.293|||||||Kruskal-Wallis|||||||0.293
71662485|NCT05502081|142838116|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71662486|NCT05502081|142838117|SUPERIORITY|||||||0.36|||||||Kruskal-Wallis|||||||0.36
71662487|NCT05502081|142838118|SUPERIORITY|||||||0.404|||||||Kruskal-Wallis|||||||0.404
71662488|NCT05502081|142838119|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662489|NCT05502081|142838119|SUPERIORITY|||||||0.234|||||||Kruskal-Wallis|||||||0.234
71662490|NCT05502081|142838119|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662491|NCT05502081|142838119|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662492|NCT05502081|142838120|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662493|NCT05502081|142838120|SUPERIORITY|||||||0.223|||||||Kruskal-Wallis|||||||0.223
71662494|NCT05502081|142838120|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662495|NCT05502081|142838120|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662496|NCT05502081|142838121|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662497|NCT05502081|142838121|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||||||0.002
71662498|NCT05502081|142838121|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662499|NCT05502081|142838121|SUPERIORITY|||||||0.213|||||||Kruskal-Wallis|||||||0.213
71662500|NCT05502081|142838122|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662501|NCT05502081|142838122|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||0.478
71662502|NCT05502081|142838122|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662503|NCT05502081|142838122|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662504|NCT05502081|142838123|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662505|NCT05502081|142838123|SUPERIORITY|||||||0.413|||||||Kruskal-Wallis|||||||0.413
71662506|NCT05502081|142838123|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71833929|NCT04714320|143171966|SUPERIORITY||||||=|0.93||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 85||||=0.930
71833930|NCT04714320|143171966|SUPERIORITY||||||=|0.111||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.111
71662507|NCT05502081|142838123|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662508|NCT05502081|142838124|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||||||0.005
71662509|NCT05502081|142838124|SUPERIORITY|||||||0.155|||||||Kruskal-Wallis|||||||0.155
71662510|NCT05502081|142838124|SUPERIORITY|||||||0.022|||||||Kruskal-Wallis|||||||0.022
71662511|NCT05502081|142838124|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71662512|NCT05502081|142838125|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71833931|NCT04714320|143171966|SUPERIORITY||||||=|0.196||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 92||||=0.196
71833932|NCT04714320|143171966|SUPERIORITY||||||=|0.816||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.816
71662513|NCT05502081|142838126|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662514|NCT05502081|142838126|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71662515|NCT05502081|142838126|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71662516|NCT05502081|142838126|SUPERIORITY|||||||0.011|||||||Kruskal-Wallis|||||||0.011
71662517|NCT05502081|142838127|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
71662518|NCT05502081|142838128|SUPERIORITY|||||||0.414|||||||Wilcoxon (Mann-Whitney)|||||||0.414
71662519|NCT00176423|142838129|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71662520|NCT00176423|142838130|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71662521|NCT00176423|142838131|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71662522|NCT00176423|142838132|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71662523|NCT01755767|142838143|SUPERIORITY|||||||0.8006|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.8006
71662524|NCT01755767|142838143|SUPERIORITY||Hazard Ratio (HR)|0.9682||||0.8061|TWO_SIDED|95.0|0.7483|1.2529|||Regression, Cox|Stratified Cox Regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2529|0.7483|0.8061
71662525|NCT01755767|142838145|SUPERIORITY|||||||0.7509|||||||Log Rank|Stratified log rank between treatment arms adjusted for stratification factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||||0.7509
71662526|NCT01755767|142838145|SUPERIORITY||Hazard Ratio (HR)|0.9557||||0.716|TWO_SIDED|95.0|0.7487|1.22|||Regression, Cox|Stratified Cox regression between treatment arms adjusted for factors: vascular invasion, extra-hepatic spread, and alpha fetoprotein level.||||1.2200|0.7487|0.7160
71662527|NCT00191165|142838148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.34||95.0|-0.5|1.4|||ANOVA||Mean Difference = High Dose - Label Dose|||1.40|-0.50|0.340
71662528|NCT00191165|142838149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.388||95.0|-0.21|0.53||P-value for 12-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.53|-0.21|0.388
71662529|NCT00191165|142838149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.061||95.0|-0.02|0.99||P-value for 24-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose|||0.99|-0.02|0.061
71662530|NCT00191165|142838150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.088||95.0|-0.18|2.44|||ANOVA||Mean Difference = High Dose - Label Dose|||2.44|-0.18|0.088
71662531|NCT00998309|142838157|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders."||||=0.001
71662532|NCT00998309|142838158|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years  in the participatns of responders."||||=1.000
71662533|NCT00998309|142838159|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders."||||<0.001
71662534|NCT00998309|142838160|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders."||||=0.556
71662535|NCT00998309|142838161|SUPERIORITY_OR_OTHER||||||=|0.074|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders."||||=0.074
71662536|NCT00998309|142838162|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders."||||=1.000
71662537|NCT00998309|142838163|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders."||||=1.000
71662538|NCT00998309|142838164|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications  in the participatns of responders."||||=1.000
71662539|NCT00998309|142838165|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders."||||=1.000
71662540|NCT00998309|142838166|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders."||||=0.470
71662541|NCT00998309|142838167|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders."||||=1.000
71662542|NCT00998309|142838170|SUPERIORITY_OR_OTHER||||||=|0.657|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.657
71662543|NCT00998309|142838171|SUPERIORITY_OR_OTHER||||||=|0.145|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years or \>=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.145
71662544|NCT00998309|142838172|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.005
71662545|NCT00998309|142838173|SUPERIORITY_OR_OTHER||||||=|0.213|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.213
71662546|NCT00998309|142838174|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=1.000
71662547|NCT00998309|142838175|SUPERIORITY_OR_OTHER||||||=|0.116|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.116
71662548|NCT00998309|142838176|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||<0.001
71662549|NCT00998309|142838177|SUPERIORITY_OR_OTHER||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.645
71662550|NCT00998309|142838178|SUPERIORITY_OR_OTHER||||||=|0.679|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.679
71662551|NCT00998309|142838179|SUPERIORITY_OR_OTHER||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.234
71662552|NCT00998309|142838180|SUPERIORITY_OR_OTHER||||||=|0.039|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."||||=0.039
71662553|NCT00998309|142838181|SUPERIORITY_OR_OTHER||||||=|0.605|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female."||||=0.605
71662554|NCT00555152|142838216|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
71662555|NCT04558918|142838219|SUPERIORITY||Odds Ratio (OR)|338.25|||<|0.0001|TWO_SIDED|95.0|25.07|4564.14||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||4564.14|25.07|<0.0001
71662556|NCT04558918|142838219|SUPERIORITY||Difference in marginal proportion|80.2|||||TWO_SIDED|95.0|71.2|87.6||||||||87.6|71.2|
71662557|NCT04558918|142838220|SUPERIORITY||Odds Ratio (OR)|495.74|||<|0.0001|TWO_SIDED|95.0|24.41|10066.53||two sided unadjusted p-value|Regression, Logistic|Logistic regression model using Firth||||10066.53|24.41|<0.0001
71662558|NCT04558918|142838220|SUPERIORITY||Diff. in marginal proportion|67.0|||||TWO_SIDED|95.0|56.4|76.9||||||||76.9|56.4|
71662559|NCT04558918|142838223|OTHER||Adjusted mean difference|-0.01|||||TWO_SIDED|95.0|-0.53|0.51||||||||0.51|-0.53|
71662560|NCT04558918|142838224|OTHER||Adjusted mean difference|-1.17|||||TWO_SIDED|95.0|-4.01|1.68||||||||1.68|-4.01|
71662561|NCT04558918|142838225|SUPERIORITY||Odds Ratio (OR)|108.41|||<|0.0001|TWO_SIDED|95.0|17.25|681.24||two sided unadjusted p-value|Conditional logistic regression|||||681.24|17.25|<0.0001
71662562|NCT04558918|142838225|SUPERIORITY||Diff. in marginal proportion|68.9|||||TWO_SIDED|95.0|51.4|83.9||||||logistic regression model||83.9|51.4|
71662563|NCT04558918|142838226|SUPERIORITY||Adjusted mean diff.|3.66|||<|0.0001|TWO_SIDED|95.0|3.2|4.12||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||4.12|3.20|<0.0001
71662564|NCT04558918|142838227|SUPERIORITY||Mean Difference (Net)|8.29|||<|0.0001|TWO_SIDED|95.0|5.28|11.29||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||11.29|5.28|<0.0001
71662565|NCT04558918|142838228|SUPERIORITY||Mean Difference (Net)|-116.15|||<|0.0001|TWO_SIDED|95.0|-132.04|-100.26||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||-100.26|-132.04|<0.0001
71662566|NCT04558918|142838229|SUPERIORITY||Geometric mean ratio|0.99||||0.8361|TWO_SIDED|95.0|0.89|1.1||two sided unadjusted p-value|Mixed Model of Repeated Measures (MMRM)|||||1.10|0.89|0.8361
71740792|NCT03058692|142993496|OTHER|||||||0.96||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.96
71662567|NCT04558918|142838230|SUPERIORITY||Rate ratio|0.1||||0.01183|TWO_SIDED|95.0|0.02|0.61||two sided unadjusted p-value|Negative binomial model|||||0.61|0.02|0.01183
71662568|NCT04558918|142838230|SUPERIORITY||Rate difference|-0.6|||||TWO_SIDED|95.0|-1.24|0.04||||||||0.04|-1.24|
71662569|NCT04558918|142838231|SUPERIORITY||rate difference|0.03||||0.31731|TWO_SIDED|95.0|-0.03|0.1||two sided unadjusted p-value|Poisson model|||||0.10|-0.03|0.31731
71662570|NCT04558918|142838232|OTHER||Adjusted mean difference|1.69|||||TWO_SIDED|95.0|-16.86|20.23||||||||20.23|-16.86|
71662571|NCT04558918|142838233|OTHER||Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.97|1.3||||||||1.30|0.97|
71662572|NCT01292226|142838271|SUPERIORITY_OR_OTHER|||||||0.4505||||||Free MPA, time 0 \[trough\]|ANOVA|Analysis of variance (ANOVA)||||||0.4505
71662573|NCT01292226|142838271|SUPERIORITY_OR_OTHER|||||||0.7322||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7322
71662574|NCT01292226|142838271|SUPERIORITY_OR_OTHER|||||||0.6798||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6798
71740793|NCT03058692|142993497|OTHER|||||||0.65||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.65
71662575|NCT01292226|142838271|SUPERIORITY_OR_OTHER|||||||0.541||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.5410
71662576|NCT01292226|142838272|SUPERIORITY_OR_OTHER|||||||0.3892||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.3892
71776033|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.117|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.117
71776034|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.106|TWO_SIDED|95.0|-0.24|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.24|0.106
71776035|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.673|TWO_SIDED|95.0|-0.16|0.1|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.16|0.673
71776036|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.089|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.089
71776037|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.065|TWO_SIDED|95.0|-0.26|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.26|0.065
71662577|NCT01292226|142838272|SUPERIORITY_OR_OTHER|||||||0.6564||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.6564
71662578|NCT01292226|142838272|SUPERIORITY_OR_OTHER|||||||0.7772||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.7772
71662579|NCT01292226|142838272|SUPERIORITY_OR_OTHER|||||||0.0958||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.0958
71662580|NCT01292226|142838273|SUPERIORITY_OR_OTHER|||||||0.5796||||||Time 0 \[trough\]|ANOVA|||||||0.5796
71662581|NCT01292226|142838273|SUPERIORITY_OR_OTHER|||||||0.3428||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3428
71662582|NCT01292226|142838274|SUPERIORITY_OR_OTHER|||||||0.9372||||||Free MPA, time 0 \[trough\]|ANOVA|||||||0.9372
71662583|NCT01292226|142838274|SUPERIORITY_OR_OTHER|||||||0.9904||||||Total MPA, time 0 \[trough\]|ANOVA|||||||0.9904
71662584|NCT01292226|142838274|SUPERIORITY_OR_OTHER|||||||0.3658||||||Free MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3658
71662585|NCT01292226|142838274|SUPERIORITY_OR_OTHER|||||||0.2987||||||Total MPA, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.2987
71662586|NCT01292226|142838275|SUPERIORITY_OR_OTHER|||||||0.7455||||||time 0 \[trough\]|ANOVA|||||||0.7455
71662587|NCT01292226|142838275|SUPERIORITY_OR_OTHER|||||||0.8504||||||Time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.8504
71662588|NCT01292226|142838276|SUPERIORITY_OR_OTHER|||||||0.6847||||||IMPDH I, time 0 \[trough\]|ANOVA|||||||0.6847
71662589|NCT01292226|142838276|SUPERIORITY_OR_OTHER|||||||0.3184||||||IMPDH I, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.3184
71662590|NCT01292226|142838276|SUPERIORITY_OR_OTHER|||||||0.3862||||||IMPDH II, time 0 \[trough\]|ANOVA|||||||0.3862
71662591|NCT01292226|142838276|SUPERIORITY_OR_OTHER|||||||0.904||||||IMPDH II, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9040
71662592|NCT01292226|142838276|SUPERIORITY_OR_OTHER|||||||0.0907||||||IMPDH activity, time 0 \[trough\]|ANOVA|||||||0.0907
71662593|NCT01292226|142838276|SUPERIORITY_OR_OTHER|||||||0.963||||||IMPDH activity, time 120 \[2 hours after administration at Week 12\]|ANOVA|||||||0.9630
71662594|NCT01292226|142838277|SUPERIORITY_OR_OTHER|||||||0.413||||||IMPDH I|ANOVA|||||||0.4130
71662595|NCT01292226|142838277|SUPERIORITY_OR_OTHER|||||||0.3823||||||IMPDH II|ANOVA|||||||0.3823
71662596|NCT01292226|142838278|SUPERIORITY_OR_OTHER|||||||0.0316||||||IMPDH I|ANOVA|||||||0.0316
71662597|NCT01292226|142838278|SUPERIORITY_OR_OTHER|||||||0.944||||||IMPDH II|ANOVA|||||||0.9440
71662598|NCT01292226|142838279|SUPERIORITY_OR_OTHER|||||||0.1328||||||IMPDH I|ANOVA|||||||0.1328
71662599|NCT01292226|142838279|SUPERIORITY_OR_OTHER|||||||0.576||||||IMPDH II|ANOVA|||||||0.5760
71662600|NCT01292226|142838280|SUPERIORITY_OR_OTHER|||||||0.7332||||||Free MPA|ANOVA|||||||0.7332
71662601|NCT01292226|142838280|SUPERIORITY_OR_OTHER|||||||0.2681||||||Total MPA|ANOVA|||||||0.2681
71662602|NCT01292226|142838280|SUPERIORITY_OR_OTHER|||||||0.7087||||||AUC MPA|ANOVA|||||||0.7087
71662603|NCT01292226|142838281|SUPERIORITY_OR_OTHER|||||||0.9432||||||Free MPA|ANOVA|||||||0.9432
71662604|NCT01292226|142838281|SUPERIORITY_OR_OTHER|||||||0.5177||||||Total MPA|ANOVA|||||||0.5177
71662605|NCT01292226|142838281|SUPERIORITY_OR_OTHER|||||||0.6398||||||AUC MPA|ANOVA|||||||0.6398
71662606|NCT01292226|142838282|SUPERIORITY_OR_OTHER|||||||0.0656||||||Free MPA|ANOVA|||||||0.0656
71662607|NCT01292226|142838282|SUPERIORITY_OR_OTHER|||||||0.0131||||||Total MPA|ANOVA|||||||0.0131
71662608|NCT01292226|142838282|SUPERIORITY_OR_OTHER|||||||0.0515||||||AUC MPA|ANOVA|||||||0.0515
71662609|NCT01844505|142838283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|99.5|0.43|0.76|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.|||0.76|0.43|<0.0001
71776038|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.567|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.567
71662610|NCT01844505|142838283|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|99.5|0.31|0.57|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.57|0.31|<0.0001
71662611|NCT01844505|142838284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|98.0|0.5|0.78|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).|Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab|||0.78|0.50|<0.0001
71662612|NCT01844505|142838284|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|98.0|0.42|0.72|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.|Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.|||0.72|0.42|<0.0001
71662613|NCT01844505|142838287|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.65|0.96|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||0.96|0.65|
71662614|NCT01844505|142838288|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.05|0.69|
71662615|NCT01844505|142838289|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.49|5.16|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.|||5.16|2.49|<0.0001
71662616|NCT01844505|142838289|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.35|||<|0.0001|TWO_SIDED|95.0|4.38|9.22|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.|||9.22|4.38|<0.0001
71776039|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.135|TWO_SIDED|95.0|-0.24|0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.03|-0.24|0.135
71662617|NCT01844505|142838289|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|26.0|||||TWO_SIDED|95.0|19.1|32.8|||||Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.|||32.8|19.1|
71662618|NCT01844505|142838289|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|39.0|||||TWO_SIDED|95.0|32.2|45.9|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.|||45.9|32.2|
71662619|NCT01844505|142838289|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.26|2.42|||||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab|||2.42|1.26|
71662620|NCT01844505|142838289|SUPERIORITY_OR_OTHER_LEGACY||Difference of Objective Response Rates|13.2|||||TWO_SIDED|95.0|5.7|20.7|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.|||20.7|5.7|
71662621|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.46|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.85|0.46|
71662622|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.28|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.54|0.28|
71662623|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.45|0.87|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||0.87|0.45|
71662624|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.34|0.59|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.59|0.34|
71662625|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.3|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.53|0.30|
71662626|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.66|1.21|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.21|0.66|
71662627|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.45|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.71|0.45|
71662628|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.33|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.53|0.33|
71662629|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.57|0.94|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||0.94|0.57|
71662630|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.27|0.6|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.60|0.27|
71662631|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.22|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.54|0.22|
71662632|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.54|1.38|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.38|0.54|
71662633|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.67|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.67|0.43|
71662634|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.54|0.34|
71740794|NCT03058692|142993497|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71740795|NCT03058692|142993498|OTHER|||||||0.35||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.35
71740796|NCT03058692|142993498|OTHER|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.66
71740797|NCT03058692|142993499|OTHER|||||||0.86||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.86
71776040|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.094|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.094
71776041|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.055|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.00|-0.27|0.055
71662635|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.63|1.01|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.01|0.63|
71740798|NCT03058692|142993499|OTHER|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.||||0.53
71776042|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.087|TWO_SIDED|95.0|-0.25|0.02|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.02|-0.25|0.087
71776043|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.542|TWO_SIDED|95.0|-0.18|0.1|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.10|-0.18|0.542
71662636|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.28|0.73|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.73|0.28|
71662637|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.16|0.49|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.49|0.16|
71662638|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.34|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.09|0.34|
71662639|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.49|1.52|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.52|0.49|
71662640|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.3|0.89|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.89|0.30|
71662641|NCT01844505|142838290|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.33|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.09|0.33|
71662642|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.57|1.05|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||1.05|0.57|
71662643|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.43|0.81|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 1%|||0.81|0.43|
71662644|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||||95.0|0.55|1.04|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 1%|||1.04|0.55|
71662645|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.39|0.68|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.68|0.39|
71662646|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.38|0.67|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 1%|||0.67|0.38|
71662647|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.72|1.31|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 1%|||1.31|0.72|
71662648|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.49|0.78|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.78|0.49|
71662649|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.41|0.66|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 5%|||0.66|0.41|
71662650|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.66|1.08|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 5%|||1.08|0.66|
71662651|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.41|0.91|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.41|
71662652|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.38|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 5%|||0.91|0.38|
71833933|NCT04714320|143171966|SUPERIORITY||||||=|0.473||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 106||||=0.473
71833934|NCT04714320|143171966|SUPERIORITY||||||=|0.615||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.615
71833935|NCT04714320|143171966|SUPERIORITY||||||=|0.214||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 120||||=0.214
71740799|NCT00571974|142993523|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||One-sided exact binomial test to compare the observed response rate to the 20% rate envisioned under the original null hypothesis.|One-sided exact binomial test|Because all but one subject responded to treatment, the Fisher's exact test was addedd.||The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall. This design's early termination rule was ≤3/9 responses in the first stage, and its success criterion was ≥7/17 responses overall. This design had 80% power at 5% alpha to distinguish an efficacious 50% response rate from a null-hypothesis 20% response rate.||||0.0001
71662653|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.62|1.53|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 5%|||1.53|0.62|
71740800|NCT00799266|142993531|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.414||||0.0392|TWO_SIDED|95.0|0.022|0.806|||ANCOVA|||Lumbar Spine BMD Z-score at Month 12||0.806|0.022|0.0392
71740801|NCT00799266|142993532|SUPERIORITY|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|0.29||||0.1322|TWO_SIDED|95.0|-0.094|0.673|||ANCOVA|||Lumbar Spine BMD Z-score at Month 6||0.673|-0.094|0.1322
71833936|NCT04714320|143171966|SUPERIORITY||||||=|0.575||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.575
71662654|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.48|0.75|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.75|0.48|
71662655|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.43|0.68|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \< 10%|||0.68|0.43|
71662656|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.71|1.14|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \< 10%|||1.14|0.71|
71662657|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.44|1.1|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||1.10|0.44|
71662658|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.32|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression \>= 10%|||0.91|0.32|
71662659|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.45|1.32|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression \>= 10%|||1.32|0.45|
71662660|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.37|1.34|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||1.34|0.37|
71662661|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.26|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline|||0.91|0.26|
71662662|NCT01844505|142838291|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.34|1.39|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline|||1.39|0.34|
71662663|NCT03395405|142838320|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.459|TWO_SIDED|95.0|0.33|1.64||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|Likelihood Ratio Test|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.|HR estimated from a Cox model|The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||1.64|0.33|0.459
71662664|NCT03395405|142838322|SUPERIORITY|||||||0.735||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significant is 0.05.|ANCOVA|Titer values were log-transformed||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until clinical resolution between study arms, with a two-sided alternative.||||0.735
71740802|NCT00799266|142993533|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|1.979||||0.0409|TWO_SIDED|95.0|0.089|3.869|||ANCOVA|||Lumbar Spine BMC at Month 6||3.869|0.089|0.0409
71740803|NCT00799266|142993533|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|2.155||||0.234|TWO_SIDED|95.0|-1.488|5.798|||ANCOVA|||Lumbar Spine BMC at Month 12||5.798|-1.488|0.2340
71740804|NCT00799266|142993534|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|34.058||||0.3827|TWO_SIDED|95.0|-45.385|113.502|||ANCOVA|||Total Body BMC at Month 6||113.502|-45.385|0.3827
71740805|NCT00799266|142993534|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|80.741||||0.2634|TWO_SIDED|95.0|-65.602|227.084|||ANCOVA|||Total Body BMC at Month 12||227.084|-65.602|0.2634
71740806|NCT00799266|142993535|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-211.782||||0.0631|TWO_SIDED|95.0|-363.765|-59.8|||ANCOVA|||Serum P1NP at Month 6||-59.800|-363.765|0.0631
71740807|NCT00799266|142993535|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-381.132||||0.0049|TWO_SIDED|95.0|-565.416|-196.848|||ANCOVA|||Serum P1NP at Month 12||-196.848|-565.416|0.0049
71833937|NCT04714320|143171966|SUPERIORITY||||||=|0.276||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 148||||=0.276
71662665|NCT03395405|142838326|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.873|TWO_SIDED|95.0|0.19|4.06||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Likelihood Ratio Test|||Includes participants in the Norovirus GII subgroup. The null hypothesis is that there is no difference in time until first negative viral load between study arms, with a two-sided alternative.||4.06|0.19|0.873
71740808|NCT00799266|142993536|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-11.223||||0.2129|TWO_SIDED|95.0|-22.595|0.149|||ANCOVA|||Serum BSAP at Month 6||0.149|-22.595|0.2129
71740809|NCT00799266|142993536|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.435||||0.0215|TWO_SIDED|95.0|-33.96|-6.909|||ANCOVA|||Serum BSAP at Month 12||-6.909|-33.960|0.0215
71740810|NCT00799266|142993537|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-20.938||||0.0254|TWO_SIDED|95.0|-33.766|-8.11|||ANCOVA|||Serum NTX at Month 6||-8.110|-33.766|0.0254
71740811|NCT00799266|142993537|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-27.574||||0.0002|TWO_SIDED|95.0|-39.037|-16.111|||ANCOVA|||Serum NTX at Month 12||-16.111|-39.037|0.0002
71740812|NCT00799266|142993538|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.874||||0.2178|TWO_SIDED|95.0|-3.931|0.182|||ANCOVA|||Serum TRAP-5b at Month 6||0.182|-3.931|0.2178
71740813|NCT00799266|142993538|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-1.837||||0.184|TWO_SIDED|95.0|-4.103|0.429|||ANCOVA|||Serum TRAP-5b at Month 12||0.429|-4.103|0.1840
71740814|NCT00799266|142993539|OTHER|The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher's exact test.||||||0.2258|||||||Fisher Exact|||New vertebral fractures at Month 12||||0.2258
71740815|NCT00799266|142993540|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.018||||0.318|TWO_SIDED|95.0|-0.055|0.019|||ANCOVA|||Vertebral morphometry at Month 12||0.019|-0.055|0.3180
71740816|NCT00799266|142993541|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.5226|TWO_SIDED|95.0|0.04|5.2|||Regression, Logistic|||Reduction in Pain at Month 3||5.20|0.04|0.5226
71740817|NCT00799266|142993541|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|999.99||||0.522|TWO_SIDED|95.0|0.01|999.99||\>999.99 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 6||999.99|0.01|0.5220
71740818|NCT00799266|142993541|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.52||||0.6019|TWO_SIDED|95.0|0.04|6.22|||Regression, Logistic|||Reduction in Pain at Month 9||6.22|0.04|0.6019
71740819|NCT00799266|142993541|OTHER|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.9652|TWO_SIDED|0.9652|0.01|999.99||0.45 (\<0.01, \>999.99)|Regression, Logistic|||Reduction in Pain at Month 12||999.99|0.01|0.9652
71740820|NCT00799266|142993542|OTHER|Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.|Difference in LS mean|-0.04||||0.5165|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||2nd metacarpal cortical width at Month 12||0.09|-0.17|0.5165
71662666|NCT00461253|142838327|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.12|0.88|
71662667|NCT00461253|142838327|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.93|1.17|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.17|0.93|
71662668|NCT00461253|142838327|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.52|1.39|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.39|0.52|
71662669|NCT00461253|142838327|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.58|1.41|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.||1.41|0.58|
71662670|NCT04240392|142838328|SUPERIORITY||Odds Ratio (OR)|1.369||||0.534|TWO_SIDED|95.0|0.462|4.055|||Mixed Models Analysis|Generalized Linear Mixed Model||||4.055|0.462|0.5340
71662671|NCT04240392|142838329|SUPERIORITY||Odds Ratio (OR)|0.803||||0.6|TWO_SIDED|95.0|0.326|1.979|||Mixed Models Analysis|Generalized Linear Mixed Model||At delivery||1.979|0.326|0.600
71662672|NCT04240392|142838329|SUPERIORITY||Odds Ratio (OR)|0.709||||0.471|TWO_SIDED|95.0|0.254|1.975|||Mixed Models Analysis|Generalized Linear Mixed Model||At 3 months post partum||1.975|0.254|0.471
71662673|NCT04240392|142838330|SUPERIORITY||Beta-coefficient|1.53||||0.518|TWO_SIDED|95.0|-3.13|6.19|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At week 36||6.19|-3.13|0.518
71662674|NCT04240392|142838330|SUPERIORITY||Beta-coefficient|0.32||||0.893|TWO_SIDED|95.0|-4.41|5.06|||Mixed Models Analysis|Repeated Measures Linear Mixed Model|Beta-coefficient for treatment for time interaction term|At 3 months post partum||5.06|-4.41|0.893
71662675|NCT03047330|142838343|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
71662676|NCT03047330|142838343|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71662677|NCT03047330|142838344|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
71662678|NCT03047330|142838344|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
71740821|NCT01013194|142993612|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||Fisher Exact|||||||0.4340
71740822|NCT01013194|142993613|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0076
71740823|NCT01013194|142993614|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||t-test, 2 sided|||Comparison at 1 year Follow-up||||0.0437
71740824|NCT03329092|142993631|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-6.6|12.4|||||The confidence interval (CI) for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.4|-6.6|
71740825|NCT03329092|142993632|OTHER||Difference in clinical cure rate|2.7|||||TWO_SIDED|95.0|-7.0|13.2|||||The CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||13.2|-7.0|
71740826|NCT03329092|142993633|OTHER||Difference in clinical cure rate|0.5|||||TWO_SIDED|95.0|-10.2|12.1|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.1|-10.2|
71740827|NCT03329092|142993634|OTHER||Difference in clinical cure rate|2.6|||||TWO_SIDED|95.0|-8.4|14.7|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||14.7|-8.4|
71740828|NCT03329092|142993635|OTHER||Difference in clinical cure rate|2.4|||||TWO_SIDED|95.0|-7.4|13.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.0|-7.4|
71740829|NCT03329092|142993635|OTHER||Difference in clinical cure rate|4.3|||||TWO_SIDED|95.0|-15.5|23.1|||Difference||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.1|-15.5|
71662679|NCT04684238|142838382|OTHER|Least square means of the difference between the treatment groups, including a 2-sided 95% confidence interval was reported in the statistical analysis. The noninferiority criterion was a relative difference of less than 15% between treatment groups.|Least square means|6.57|||||TWO_SIDED|95.0|-8.99|22.13||Noninferiority was defined as the entire 95% CI for the difference being above the noninferiority margin for the relative difference of -15%. Testing the hypothesis of no difference between isoflurane and midazolam.|Mixed Models Analysis|||||22.13|-8.99|
71662680|NCT04684238|142838383|NON_INFERIORITY|The non-inferiority margin was set to a relative difference of -15%.|Least square means|5.34|||||TWO_SIDED|95.0|-10.48|21.17||Testing the hypothesis of no difference between isoflurane and midazolam.||||||21.17|-10.48|
71662681|NCT04684238|142838384|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0004|TWO_SIDED|95.0|-3.8|-1.1|||ANCOVA|||||-1.1|-3.8|0.0004
71740830|NCT03329092|142993636|OTHER||Difference in clinical cure rate|5.6|||||TWO_SIDED|95.0|-4.0|16.6|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||16.6|-4.0|
71740831|NCT03329092|142993636|OTHER||Difference in clinical cure rate|-7.9|||||TWO_SIDED|95.0|-31.9|17.3|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||17.3|-31.9|
71740832|NCT03329092|142993663|OTHER||Difference in clinical cure rate|2.3|||||TWO_SIDED|95.0|-6.2|11.5|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||11.5|-6.2|
71740833|NCT03329092|142993664|OTHER||Difference in clinical cure|-1.2|||||TWO_SIDED|95.0|-10.7|9.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.4|-10.7|
71740834|NCT03329092|142993665|OTHER||Difference in clinical cure|0.3|||||TWO_SIDED|95.0|-8.3|9.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||9.9|-8.3|
71662682|NCT04684238|142838385|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on an analysis of variance model with treatment group as fixed effect and baseline opioid dose as covariate.|Mean Difference (Final Values)|-0.77||||0.096|TWO_SIDED|95.0|-1.69|0.14|||ANCOVA|||||0.14|-1.69|0.096
71662683|NCT04684238|142838386|SUPERIORITY||Hazard Ratio (HR)|3.3||||0.0021|TWO_SIDED|95.0|1.54|7.07|||Regression, Cox|||Time to extubation||7.07|1.54|0.0021
71662684|NCT04684238|142838387|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.636|TWO_SIDED|95.0|-0.15|0.25|||ANOVA|||Spontaneous breathing efforts. Results display a comparison between isoflurane and midazolam and are based on a mixed effects analysis of variance model with treatment group as fixed effect.||0.25|-0.15|0.636
71662685|NCT04684238|142838388|SUPERIORITY|Results display comparison between isoflurane and midazolam and are based on a Wilcoxon ranksum test.||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at ≤24 hours.||||0.55
71662686|NCT04684238|142838388|SUPERIORITY|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||Need for inotropic/vasopressor agent at \>24 hours.||||0.637
71662687|NCT02585934|142838396|SUPERIORITY||least square mean difference|-0.36||||0.2249|TWO_SIDED|95.0|-0.95|0.22||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.22|-0.95|0.2249
71662688|NCT02585934|142838397|SUPERIORITY||least square mean difference|-0.09||||0.826|TWO_SIDED|95.0|-0.9|0.72||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.72|-0.90|0.8260
71662689|NCT02585934|142838398|SUPERIORITY||least square mean difference|-0.12||||0.0234|TWO_SIDED|95.0|-0.22|-0.02||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||-0.02|-0.22|0.0234
71662690|NCT02585934|142838399|SUPERIORITY||least square mean difference|0.12||||0.2096|TWO_SIDED|95.0|-0.07|0.32||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.32|-0.07|0.2096
71662691|NCT02585934|142838400|SUPERIORITY||least square mean difference|-0.14||||0.765|TWO_SIDED|95.0|-1.09|0.8||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.80|-1.09|0.7650
71662692|NCT02585934|142838401|SUPERIORITY||least square mean difference|-0.38||||0.2472|TWO_SIDED|95.0|-1.03|0.27||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||0.27|-1.03|0.2472
71740835|NCT03329092|142993666|OTHER||Difference in clinical cure rate|1.0|||||TWO_SIDED|95.0|-8.5|12.0|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|||12.0|-8.5|
71740836|NCT03329092|142993667|OTHER||Difference in clinical cure rate|1.9|||||TWO_SIDED|95.0|-6.9|11.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||11.9|-6.9|
71740837|NCT03329092|142993667|OTHER||Difference in clinical cure rate|3.9|||||TWO_SIDED|95.0|-15.2|23.4|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||23.4|-15.2|
71740838|NCT03329092|142993668|OTHER||Difference in clinical cure rate|3.1|||||TWO_SIDED|95.0|-5.2|13.2|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|cIAI||13.2|-5.2|
71740839|NCT03329092|142993668|OTHER||Difference in clinical cure rate|-10.4|||||TWO_SIDED|95.0|-32.6|14.9|||||CI for the difference was calculated using the unstratified Miettinen and Nurminen method.|HAP/VAP||14.9|-32.6|
71740840|NCT01456169|142993716|SUPERIORITY_OR_OTHER||LS mean difference|-14.7|||<|0.001|TWO_SIDED|95.0|-17.6|-11.8|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate.||The type I error was controlled using a 2-step hierarchical testing procedure. In the first step, the high dose (40/25 mg) of Azilsartan medoxomil + chlorthalidone was compared to Azilsartan medoxomil alone. If the comparison in step 1 was statistically significant at a significance level of 5%, then step 2 was performed by comparing the low dose (40/12.5 mg) and monotherapy at the 5% significance level.||-11.8|-17.6|<0.001
71740841|NCT01456169|142993716|SUPERIORITY_OR_OTHER||LS mean difference|-9.5|||<|0.001|TWO_SIDED|95.0|-12.4|-6.5|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate||||-6.5|-12.4|<0.001
71740842|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (\>) -0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).||2.1|-2.2|
71662693|NCT00110136|142838425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_DEVIATION|2.02||0.2629|TWO_SIDED|95.0|-2.36|0.74||Paired t-test; no adjustments for multiple comparisons|paired t-test||The difference is post minus pre so negative values represents fewer hot flashes after treatment.|Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.||0.74|-2.36|0.2629
71662694|NCT00110136|142838426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.37|STANDARD_DEVIATION|7.91||0.1365|TWO_SIDED|95.0|-10.45|1.72||Paired t-test; unadjusted for multiple comparisons.|paired t-test||Difference in hot flash score is post minus pre so a negative value represents a decrease in the frequency and/or severity of the hot flashes.|Assessment of the change in the hot flash score over time||1.72|-10.45|0.1365
71740843|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-1.7|||||TWO_SIDED|95.0|-5.2|1.1||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||1.1|-5.2|
71740844|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
71776044|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.643|TWO_SIDED|95.0|-0.17|0.11|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.17|0.643
71740845|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
71740846|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.1|-2.1|
71740847|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.3|||||TWO_SIDED|95.0|-1.1|6.3||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||6.3|-1.1|
71740848|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.9|-4.2|
71740849|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
71740850|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
71740851|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|2.9|||||TWO_SIDED|95.0|-0.2|6.7||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||6.7|-0.2|
71740852|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|1.7|||||TWO_SIDED|95.0|-1.9|5.8||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||5.8|-1.9|
71740853|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|0.9|7.3||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|0.9|
71776045|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.301|TWO_SIDED|95.0|-0.21|0.07|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.07|-0.21|0.301
71776046|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.237|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.05|-0.22|0.237
71740854|NCT01200368|142993770|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|3.4|||||TWO_SIDED|95.0|1.0|7.3||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||7.3|1.0|
71740855|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.94|0.71|
71740856|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.97|0.64|
71740857|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.74|||||TWO_SIDED|95.0|0.64|0.86||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.86|0.64|
71740858|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.70|
71740859|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.85|0.63|
71740860|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.08|0.72|
71740861|NCT01200368|142993771|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.66|
71776047|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.36|TWO_SIDED|95.0|-0.18|0.06|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.06|-0.18|0.360
71740862|NCT01200368|142993772|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
71740863|NCT01200368|142993772|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.2|-2.1|
71740864|NCT01200368|142993772|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
71740865|NCT01200368|142993772|SUPERIORITY_OR_OTHER||Percent difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.6|-3.1|
71740866|NCT01200368|142993773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.8|||||TWO_SIDED|95.0|1.5|2.15||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.15|1.50|
71740867|NCT01200368|142993773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.92|1.28||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.28|0.92|
71740868|NCT01200368|142993773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.86|1.22||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.22|0.86|
71740869|NCT01200368|142993773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.87|1.25||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.25|0.87|
71740870|NCT01200368|142993773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.83|||||TWO_SIDED|95.0|1.54|2.16||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.16|1.54|
71740871|NCT01200368|142993773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.89|||||TWO_SIDED|95.0|1.59|2.25||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.25|1.59|
71740872|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 4: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71776048|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.854|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.11|-0.13|0.854
71776049|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.076|TWO_SIDED|95.0|-0.23|0.01|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.23|0.076
71662695|NCT00110136|142838428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|7.0||0.832|TWO_SIDED|95.0|-4.84|5.92||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in MCS from baseline to four weeks (post minus pre) so values greater than zero reflect improvement in QOL.|Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.||5.92|-4.84|0.8320
71662696|NCT00110136|142838429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.43||0.9995|TWO_SIDED|95.0|-5.71|5.71||Paired t-test on the change in PCS from baseline to four weeks; unadjusted for multiple comparisons.|paired t-test||This is the change in PCS from baseline to four weeks (post minus pre), so positive numbers represent improvement in QOL.|Assess the change in PCS from baseline to four weeks; null hypothesis is no change.||5.71|-5.71|0.9995
71662697|NCT00110136|142838430|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.35|STANDARD_DEVIATION|7.12||0.1042|TWO_SIDED|95.0|-1.12|9.822||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in mood from baseline to four weeks (post minus pre). Mood is scored so that higher numbers represent better mood so positive changes represent an improvement in mood.|Assess the change in mood from baseline to four weeks. Null hypothesis is no change.||9.822|-1.12|0.1042
71662698|NCT03400943|142838434|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.0001|TWO_SIDED|95.0|0.33|0.78|||Cochran-Mantel-Haenszel||Number of subjects per treatment: 41 (Vilaprisan) / 20 (Placebo).|Vilaprisan (A1) and Vilaprisan+Placebo (B2) combined vs. Placebo+Vilaprisan (B1) in treatment period 1||0.78|0.33|<.0001
71662699|NCT02563106|142838441|OTHER|The analysis of the primary endpoint was based on the mITT analysis set. Per-protocol and worse case analyses were performed as sensitivity analyses.The P-value was based on a one-sided z-test for the comparison of the treatment difference between the SYN-004 group and the Placebo group.|Relative Risk Reduction (%)|71.4||||0.045|TWO_SIDED|95.0|-35.9|94.0||Study was designed to provide 80% power to detect treatment effect with one-sided alpha = 0.05 on the primary endpoint. Based on the pre-specified z-test the one-sided P=0.045.|z-test|1-sided P=0.045.|Relative Risk Reduction in SYN-004 group compared to Placebo group.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1 dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.||94.0|-35.9|0.045
71662700|NCT00537303|142838465|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set|Mean Difference (Final Values)|0.06||||0.606||95.0|-0.17|0.29||P-value for test of difference between treatments.|ANCOVA|Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.29|-0.17|0.606
71662701|NCT00537303|142838466|NON_INFERIORITY_OR_EQUIVALENCE|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.|Mean Difference (Final Values)|0.03||||0.816||95.0|-0.21|0.26||P-value for test of difference between treatments.|ANCOVA|||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.||0.26|-0.21|0.816
71662702|NCT04005352|142838515|SUPERIORITY||||||<|0.0001|ONE_SIDED|||||with significance level of 0.025|Wilcoxon (Mann-Whitney)|||||||<0.0001
71662703|NCT04005352|142838516|NON_INFERIORITY|4 letter margin (1-sided)|Difference|0.1|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-1.3|1.5|||ANOVA|||||1.5|-1.3|<0.0001
71740873|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 6B: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71662704|NCT04005352|142838517|SUPERIORITY||||||<|0.0001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71662705|NCT04005352|142838518|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71662706|NCT04005352|142838519|SUPERIORITY|Week 14|Odds Ratio (OR)|1.6||||0.051|TWO_SIDED|95.0|0.9|2.7|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||2.7|0.9|0.0510
71662707|NCT04005352|142838519|SUPERIORITY|Week 16|Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||likelihood ratio test|Assessed at one-sided 0.025 significance level||||3.9|1.7|<0.0001
71662708|NCT04005352|142838522|SUPERIORITY||Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.84||0.8137|TWO_SIDED|95.0|-1.9|1.5||p-value for treatment difference|ANOVA|||||1.5|-1.9|0.8137
71662709|NCT04005352|142838523|SUPERIORITY|Week 32|Odds Ratio (OR)|1.0||||0.4106|TWO_SIDED|95.0|0.7|1.3|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.3|0.7|0.4106
71740874|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 9V: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71662710|NCT04005352|142838523|SUPERIORITY|Week 64|Odds Ratio (OR)|1.0||||0.4667|TWO_SIDED|95.0|0.7|1.4|||likelihood ratio test|adjusting for baseline BCVA categories (\<55, 55-\<73, ≥73 letters).||||1.4|0.7|0.4667
71740875|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 14: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71662711|NCT04005352|142838524|SUPERIORITY|Week 32|Odds Ratio (OR)|1.1||||0.2397|TWO_SIDED|95.0|0.8|1.7|||likelihood ratio test|assessed at the 0.025 significance level||||1.7|0.8|0.2397
71662712|NCT04005352|142838524|SUPERIORITY|Week 64|Odds Ratio (OR)|1.2||||0.115|TWO_SIDED|95.0|0.9|1.8|||likelihood ratio test|assessed at the 0.025 significance level||||1.8|0.9|0.1150
71662713|NCT04005352|142838525|SUPERIORITY|Weeks 28 and 32|Difference|-26.9|STANDARD_ERROR_OF_MEAN|9.87||0.0066|TWO_SIDED|95.0|-46.3|-7.5|||ANOVA|||||-7.5|-46.3|0.0066
71662714|NCT04005352|142838525|SUPERIORITY|Weeks 60 and 64|Difference|-15.4|STANDARD_ERROR_OF_MEAN|11.26||0.1714|TWO_SIDED|95.0|-37.6|6.7|||ANOVA|||||6.7|-37.6|0.1714
71662715|NCT04005352|142838528|SUPERIORITY|Week 32|LS Mean Difference|0.37||||0.193|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.193
71662716|NCT04005352|142838528|SUPERIORITY|Week 64|LS Mean Difference|-2.0||||0.052|TWO_SIDED|95.0|-3.9|0.0|||ANCOVA|||||0.0|-3.9|0.052
71662717|NCT04005352|142838529|SUPERIORITY|Week 32|LS Mean Difference|2.16||||0.081|TWO_SIDED|95.0|-0.3|4.6|||ANCOVA|||||4.6|-0.3|0.081
71662718|NCT04005352|142838529|SUPERIORITY|Week 64|LS Mean Difference|-0.7||||0.59|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.590
71662719|NCT04005352|142838530|SUPERIORITY|Week 32|LS Mean Difference|0.77||||0.558|TWO_SIDED|95.0|-1.8|3.4|||ANCOVA|||||3.4|-1.8|0.558
71662720|NCT04005352|142838530|SUPERIORITY|Week 64|LS Mean Difference|-1.9||||0.138|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|||||0.6|-4.5|0.138
71662721|NCT04005352|142838531|SUPERIORITY|Week 32|LS Mean Difference|1.6||||0.287|TWO_SIDED|95.0|-1.4|4.6|||ANCOVA|||||4.6|-1.4|0.287
71740876|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 18C: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71662722|NCT04005352|142838531|SUPERIORITY|Week 64|LS Mean Difference|-3.0||||0.07|TWO_SIDED|95.0|-6.2|0.2|||ANCOVA|||||0.2|-6.2|0.070
71662723|NCT04005352|142838532|SUPERIORITY|Week 32|LS Mean Difference|-0.71||||0.602|TWO_SIDED|95.0|-3.4|2.0|||ANCOVA|||||2.0|-3.4|0.602
71662724|NCT04005352|142838532|SUPERIORITY|Week 64|LS Mean Difference|-2.5||||0.086|TWO_SIDED|95.0|-5.3|0.4|||ANCOVA|||||0.4|-5.3|0.086
71662725|NCT04005352|142838533|SUPERIORITY|Week 32|LS Mean Difference|1.55||||0.174|TWO_SIDED|95.0|-0.7|3.8|||ANCOVA|||||3.8|-0.7|0.174
71662726|NCT04005352|142838533|SUPERIORITY|Week 64|LS Mean Difference|-1.5||||0.21|TWO_SIDED|95.0|-3.8|0.8|||ANCOVA|||||0.8|-3.8|0.210
71662727|NCT04005352|142838534|SUPERIORITY|Week 32|LS Mean Difference|-0.96||||0.499|TWO_SIDED|95.0|-3.8|1.8|||ANCOVA|||||1.8|-3.8|0.499
71740877|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|-0.6|||||TWO_SIDED|95.0|-3.9|2.4||||||Serotype 19F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-3.9|
71662728|NCT04005352|142838534|SUPERIORITY|Week 64|LS Mean Difference|-2.3||||0.147|TWO_SIDED|95.0|-5.4|0.8|||ANCOVA|||||0.8|-5.4|0.147
71662729|NCT04005352|142838535|SUPERIORITY|Week 32|LS Mean Difference|0.88||||0.643|TWO_SIDED|95.0|-2.8|4.6|||ANCOVA|||||4.6|-2.8|0.643
71662730|NCT04005352|142838535|SUPERIORITY|Week 64|LS Mean Difference|-1.3||||0.507|TWO_SIDED|95.0|-5.0|2.5|||ANCOVA|||||2.5|-5.0|0.507
71662731|NCT04005352|142838536|SUPERIORITY|Week 32|LS Mean Difference|0.49||||0.7|TWO_SIDED|95.0|-2.0|3.0|||ANCOVA|||||3.0|-2.0|0.700
71662732|NCT04005352|142838536|SUPERIORITY|Week 64|LS Mean Difference|-2.9||||0.07|TWO_SIDED|95.0|-6.0|0.2|||ANCOVA|||||0.2|-6.0|0.070
71662733|NCT04005352|142838537|SUPERIORITY|Week 32|LS Mean Difference|0.73||||0.741|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||||5.1|-3.6|0.741
71662734|NCT04005352|142838537|SUPERIORITY|Week 64|LS Mean Difference|-1.7||||0.494|TWO_SIDED|95.0|-6.6|3.2|||ANCOVA|||||3.2|-6.6|0.494
71662735|NCT04005352|142838538|SUPERIORITY|Week 32|LS Mean Difference|1.76||||0.054|TWO_SIDED|95.0|0.0|3.5|||ANCOVA|||||3.5|-0.0|0.054
71776050|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.957|TWO_SIDED|95.0|-0.12|0.12|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.12|-0.12|0.957
71662736|NCT04005352|142838538|SUPERIORITY|Week 64|LS Mean Difference|-1.1||||0.331|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.331
71662737|NCT04005352|142838539|SUPERIORITY|Week 32|LS Mean Difference|1.24||||0.394|TWO_SIDED|95.0|-1.6|4.1|||ANCOVA|||||4.1|-1.6|0.394
71662738|NCT04005352|142838539|SUPERIORITY|Week 64|LS Mean Difference|-0.5||||0.728|TWO_SIDED|95.0|-3.6|2.5|||ANCOVA|||||2.5|-3.6|0.728
71662739|NCT00936897|142838542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.0|1.8|||ANCOVA||Denosumab - Ibandronate|||1.8|1.0|<0.0001
71662740|NCT00936897|142838543|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71662741|NCT00936897|142838544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||<|0.0001|TWO_SIDED|95.0|0.7|1.7|||ANCOVA||Denosumab - Ibandronate|||1.7|0.7|<0.0001
71662742|NCT00936897|142838545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.5|||ANCOVA||Denosumab - Ibandronate|||2.5|1.5|<0.0001
71662743|NCT02792699|142838551|OTHER||Geometric LS Mean|152371.4|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662744|NCT02792699|142838551|OTHER||LS Geometric Mean|159236.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662745|NCT02792699|142838551|OTHER||LS Geometric Mean|172213.2|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662746|NCT02792699|142838551|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9569|||||TWO_SIDED|90.0|0.887|1.0323||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0323|0.8870|
71662747|NCT02792699|142838551|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8848|||||TWO_SIDED|90.0|0.8204|0.9542||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9542|0.8204|
71662748|NCT02792699|142838551|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9246|||||TWO_SIDED|90.0|0.8575|0.997||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9970|0.8575|
71662749|NCT02792699|142838552|OTHER||Geometric LS Mean|368.43|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662750|NCT02792699|142838552|OTHER||LS Geometric Mean|374.44|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662751|NCT02792699|142838552|OTHER||LS Geometric Mean|393.29|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662752|NCT02792699|142838552|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.984|||||TWO_SIDED|90.0|0.9356|1.0348||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0348|0.9356|
71662753|NCT02792699|142838552|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9368|||||TWO_SIDED|90.0|0.8912|0.9848||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9848|0.8912|
71662754|NCT02792699|142838552|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9521|||||TWO_SIDED|90.0|0.9055|1.001||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0010|0.9055|
71662755|NCT02792699|142838553|OTHER||Geometric LS Mean|42203.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71776051|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.404|TWO_SIDED|95.0|-0.19|0.08|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.08|-0.19|0.404
71662756|NCT02792699|142838553|OTHER||LS Geometric Mean|43378.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662757|NCT02792699|142838553|OTHER||LS Geometric Mean|44925.3|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662758|NCT02792699|142838553|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9729|||||TWO_SIDED|90.0|0.9174|1.0318||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0318|0.9174|
71662759|NCT02792699|142838553|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9394|||||TWO_SIDED|90.0|0.8863|0.9958||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9958|0.8863|
71662760|NCT02792699|142838553|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9656|||||TWO_SIDED|90.0|0.9104|1.024||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0240|0.9104|
71662761|NCT02792699|142838554|OTHER||Geometric LS Mean|149590.5|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662762|NCT02792699|142838554|OTHER||LS Geometric Mean|155778.7|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662763|NCT02792699|142838554|OTHER||LS Geometric Mean|166811.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71740878|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.4||||||Serotype 23F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.||2.4|-2.4|
71740879|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 1: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
71662764|NCT02792699|142838554|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.895|1.0303||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0303|0.8950|
71662765|NCT02792699|142838554|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8968|||||TWO_SIDED|90.0|0.8363|0.9616||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9616|0.8363|
71662766|NCT02792699|142838554|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9339|||||TWO_SIDED|90.0|0.8707|1.0016||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0016|0.8707|
71662767|NCT02792699|142838555|OTHER||Geometric LS Mean|304.04|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662768|NCT02792699|142838555|OTHER||LS Geometric Mean|305.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662769|NCT02792699|142838555|OTHER||LS Geometric Mean|320.87|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.|||||
71662770|NCT02792699|142838555|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[US\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9942|||||TWO_SIDED|90.0|0.9461|1.0448||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0448|0.9461|
71662771|NCT02792699|142838555|EQUIVALENCE|PK similarity between the test (ABP 798) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9475|||||TWO_SIDED|90.0|0.9021|0.9953||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||0.9953|0.9021|
71662772|NCT02792699|142838555|EQUIVALENCE|PK similarity between the test (rituximab \[US\]) and reference (rituximab \[EU\]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9531|||||TWO_SIDED|90.0|0.907|1.0015||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.||1.0015|0.9070|
71662773|NCT02792699|142838564|EQUIVALENCE|Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).|LS Mean Difference|0.02|||||TWO_SIDED|90.0|-0.225|0.264||||||If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.||0.264|-0.225|
71662774|NCT02792699|142838564|OTHER||LS Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.353|0.213||||||||0.213|-0.353|
71662775|NCT02792699|142838564|OTHER||LS Mean Difference|0.11|||||TWO_SIDED|90.0|-0.171|0.392||||||||0.392|-0.171|
71662776|NCT02792699|142838565|OTHER||LS Mean Difference|0.064|||||TWO_SIDED|90.0|-0.203|0.33||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.330|-0.203|
71662777|NCT02792699|142838565|OTHER||LS Mean Difference|-0.147|||||TWO_SIDED|90.0|-0.411|0.117||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.117|-0.411|
71662778|NCT02792699|142838565|OTHER||LS Mean Difference|0.502|||||TWO_SIDED|90.0|0.233|0.772||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.772|0.233|
71662779|NCT02792699|142838565|OTHER||LS Mean Difference|0.27|||||TWO_SIDED|90.0|0.0|0.539||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.539|0.000|
71662780|NCT02792699|142838565|OTHER||LS Mean Difference|0.255|||||TWO_SIDED|90.0|-0.04|0.55||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.550|-0.040|
71662781|NCT02792699|142838565|OTHER||LS Mean Difference|0.16|||||TWO_SIDED|90.0|-0.135|0.455||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.455|-0.135|
71662782|NCT02792699|142838565|OTHER||LS Mean Difference|0.262|||||TWO_SIDED|90.0|-0.04|0.564||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.564|-0.040|
71662783|NCT02792699|142838565|OTHER||LS Mean Difference|0.08|||||TWO_SIDED|90.0|-0.216|0.376||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.376|-0.216|
71662784|NCT02792699|142838566|OTHER||Risk Ratio (RR)|0.9339|||||TWO_SIDED|90.0|0.7696|1.1332||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1332|0.7696|
71662785|NCT02792699|142838566|OTHER||Risk Difference (RD)|-0.036|||||TWO_SIDED|90.0|-0.1495|0.0775||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0775|-0.1495|
71662786|NCT02792699|142838566|OTHER||Risk Ratio (RR)|1.0392|||||TWO_SIDED|90.0|0.8436|1.2801||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2801|0.8436|
71662787|NCT02792699|142838566|OTHER||Risk Difference (RD)|0.0246|||||TWO_SIDED|90.0|-0.091|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0910|
71662788|NCT02792699|142838566|OTHER||Risk Ratio (RR)|0.878|||||TWO_SIDED|90.0|0.7573|1.0179||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0179|0.7573|
71662789|NCT02792699|142838566|OTHER||Risk Difference (RD)|-0.0794|||||TWO_SIDED|90.0|-0.1834|0.0247||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0247|-0.1834|
71662790|NCT02792699|142838566|OTHER||Risk Ratio (RR)|1.0426|||||TWO_SIDED|90.0|0.877|1.2394||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2394|0.8770|
71662791|NCT02792699|142838566|OTHER||Risk Difference (RD)|0.0348|||||TWO_SIDED|90.0|-0.0758|0.1454||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1454|-0.0758|
71662792|NCT02792699|142838566|OTHER||Risk Ratio (RR)|1.0102|||||TWO_SIDED|90.0|0.8743|1.1671||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1671|0.8743|
71662793|NCT02792699|142838566|OTHER||Risk Difference (RD)|0.0199|||||TWO_SIDED|90.0|-0.0835|0.1234||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1234|-0.0835|
71662794|NCT02792699|142838566|OTHER||Risk Ratio (RR)|1.0793|||||TWO_SIDED|90.0|0.9244|1.2601||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2601|0.9244|
71662795|NCT02792699|142838566|OTHER||Risk Difference (RD)|0.0561|||||TWO_SIDED|90.0|-0.0493|0.1615||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1615|-0.0493|
71662796|NCT02792699|142838566|OTHER||Risk Ratio (RR)|0.8848|||||TWO_SIDED|90.0|0.7759|1.0091||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0091|0.7759|
71662797|NCT02792699|142838566|OTHER||Risk Difference (RD)|-0.0776|||||TWO_SIDED|90.0|-0.1789|0.0237||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0237|-0.1789|
71662798|NCT02792699|142838566|OTHER||Risk Ratio (RR)|0.9982|||||TWO_SIDED|90.0|0.8585|1.1605||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.1605|0.8585|
71662799|NCT02792699|142838566|OTHER||Risk Difference (RD)|0.0008|||||TWO_SIDED|90.0|-0.1038|0.1054||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1054|-0.1038|
71662800|NCT02792699|142838566|OTHER||Risk Ratio (RR)|0.7862|||||TWO_SIDED|90.0|0.6722|0.9196||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9196|0.6722|
71662801|NCT02792699|142838566|OTHER||Risk Difference (RD)|-0.2004|||||TWO_SIDED|90.0|-0.3066|-0.0941||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0941|-0.3066|
71662802|NCT02792699|142838566|OTHER||Risk Ratio (RR)|0.8804|||||TWO_SIDED|90.0|0.7587|1.0215||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0215|0.7587|
71662803|NCT02792699|142838566|OTHER||Risk Difference (RD)|-0.1037|||||TWO_SIDED|90.0|-0.2066|-0.0007||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||-0.0007|-0.2066|
71662804|NCT02792699|142838567|OTHER||Risk Ratio (RR)|0.9256|||||TWO_SIDED|90.0|0.64|1.3388||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3388|0.6400|
71662805|NCT02792699|142838567|OTHER||Risk Difference (RD)|-0.0181|||||TWO_SIDED|90.0|-0.1209|0.0847||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0847|-0.1209|
71662806|NCT02792699|142838567|OTHER||Risk Ratio (RR)|1.0868|||||TWO_SIDED|90.0|0.7328|1.6119||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6119|0.7328|
71662807|NCT02792699|142838567|OTHER||Risk Difference (RD)|0.0201|||||TWO_SIDED|90.0|-0.0803|0.1205||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1205|-0.0803|
71662808|NCT02792699|142838567|OTHER||Risk Ratio (RR)|0.7095|||||TWO_SIDED|90.0|0.5387|0.9346||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.9346|0.5387|
71662809|NCT02792699|142838567|OTHER||Risk Difference (RD)|-0.1109|||||TWO_SIDED|90.0|-0.2231|0.0013||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0013|-0.2231|
71662810|NCT02792699|142838567|OTHER||Risk Ratio (RR)|1.0882|||||TWO_SIDED|90.0|0.7829|1.5127||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.5127|0.7829|
71662811|NCT02792699|142838567|OTHER||Risk Difference (RD)|0.0441|||||TWO_SIDED|90.0|-0.0626|0.1508||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1508|-0.0626|
71662812|NCT02792699|142838567|OTHER||Risk Ratio (RR)|0.9612|||||TWO_SIDED|90.0|0.7273|1.2705||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2705|0.7273|
71662813|NCT02792699|142838567|OTHER||Risk Difference (RD)|0.002|||||TWO_SIDED|90.0|-0.1081|0.1122||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1122|-0.1081|
71662814|NCT02792699|142838567|OTHER||Risk Ratio (RR)|1.0029|||||TWO_SIDED|90.0|0.756|1.3305||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3305|0.7560|
71776052|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.128|TWO_SIDED|95.0|-0.03|0.23|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.23|-0.03|0.128
71662815|NCT02792699|142838567|OTHER||Risk Difference (RD)|0.0039|||||TWO_SIDED|90.0|-0.1056|0.1135||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1135|-0.1056|
71662816|NCT02792699|142838567|OTHER||Risk Ratio (RR)|0.8373|||||TWO_SIDED|90.0|0.6797|1.0316||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0316|0.6797|
71662817|NCT02792699|142838567|OTHER||Risk Difference (RD)|-0.0863|||||TWO_SIDED|90.0|-0.2029|0.0302||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0302|-0.2029|
71776053|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.07||0.577|TWO_SIDED|95.0|-0.17|0.09|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.09|-0.17|0.577
71662818|NCT02792699|142838567|OTHER||Risk Ratio (RR)|1.1191|||||TWO_SIDED|90.0|0.878|1.4264||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4264|0.8780|
71662819|NCT02792699|142838567|OTHER||Risk Difference (RD)|0.0288|||||TWO_SIDED|90.0|-0.0827|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1402|-0.0827|
71776054|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.07||0.068|TWO_SIDED|95.0|-0.01|0.25|||ANCOVA|||Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.25|-0.01|0.068
71662820|NCT02792699|142838567|OTHER||Risk Ratio (RR)|0.8376|||||TWO_SIDED|90.0|0.6807|1.0307||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0307|0.6807|
71662821|NCT02792699|142838567|OTHER||Risk Difference (RD)|-0.0781|||||TWO_SIDED|90.0|-0.2014|0.0452||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0452|-0.2014|
71662822|NCT02792699|142838567|OTHER||Risk Ratio (RR)|1.0548|||||TWO_SIDED|90.0|0.8351|1.3321||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3321|0.8351|
71662823|NCT02792699|142838567|OTHER||Risk Difference (RD)|0.0141|||||TWO_SIDED|90.0|-0.1021|0.1303||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1303|-0.1021|
71662824|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.5926|||||TWO_SIDED|90.0|0.2818|1.2462||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.2462|0.2818|
71662825|NCT02792699|142838568|OTHER||Risk Difference (RD)|-0.0574|||||TWO_SIDED|90.0|-0.1285|0.0136||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0136|-0.1285|
71662826|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.7476|||||TWO_SIDED|90.0|0.3383|1.6519||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.6519|0.3383|
71662827|NCT02792699|142838568|OTHER||Risk Difference (RD)|-0.0327|||||TWO_SIDED|90.0|-0.0962|0.0308||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0308|-0.0962|
71662828|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.6346|||||TWO_SIDED|90.0|0.3704|1.0872||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0872|0.3704|
71662829|NCT02792699|142838568|OTHER||Risk Difference (RD)|-0.0569|||||TWO_SIDED|90.0|-0.1448|0.031||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0310|-0.1448|
71662830|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.7857|||||TWO_SIDED|90.0|0.445|1.3874||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.3874|0.4450|
71662831|NCT02792699|142838568|OTHER||Risk Difference (RD)|-0.0417|||||TWO_SIDED|90.0|-1237.0|0.0403||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0403|-1237|
71662832|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.9254|||||TWO_SIDED|90.0|0.5772|1.4838||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4838|0.5772|
71662833|NCT02792699|142838568|OTHER||Risk Difference (RD)|0.0156|||||TWO_SIDED|90.0|-0.078|0.1092||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1092|-0.0780|
71662834|NCT02792699|142838568|OTHER||Risk Ratio (RR)|1.112|||||TWO_SIDED|90.0|0.6722|1.8398||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.8398|0.6722|
71662835|NCT02792699|142838568|OTHER||Risk Difference (RD)|0.0244|||||TWO_SIDED|90.0|-0.063|0.1119||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1119|-0.0630|
71662836|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.9798|||||TWO_SIDED|90.0|0.6675|1.4384||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.4384|0.6675|
71662837|NCT02792699|142838568|OTHER||Risk Difference (RD)|0.0375|||||TWO_SIDED|90.0|-0.0707|0.1456||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1456|-0.0707|
71662838|NCT02792699|142838568|OTHER||Risk Ratio (RR)|1.1831|||||TWO_SIDED|90.0|0.7833|1.787||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7870|0.7833|
71662839|NCT02792699|142838568|OTHER||Risk Difference (RD)|0.0752|||||TWO_SIDED|90.0|-0.0297|0.1802||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1802|-0.0297|
71776055|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.016|TWO_SIDED|95.0|-0.27|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.27|0.016
71662840|NCT02792699|142838568|OTHER||Risk Ratio (RR)|0.7027|||||TWO_SIDED|90.0|0.493|1.0017||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.0017|0.4930|
71662841|NCT02792699|142838568|OTHER||Risk Difference (RD)|-0.0908|||||TWO_SIDED|90.0|-0.211|0.0294||||||Risk difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.0294|-0.2110|
71662842|NCT02792699|142838568|OTHER||Risk Ratio (RR)|1.1449|||||TWO_SIDED|90.0|0.7601|1.7246||||||Risk ratio (ABP 798/ABP 798 versus Rituximab \[US\]/ABP 798\]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||1.7246|0.7601|
71776056|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.38|<0.001
71776057|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.44|-0.19|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.19|-0.44|<0.001
71776058|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.39|-0.15|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.39|<0.001
71776059|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.037|TWO_SIDED|95.0|-0.27|-0.01|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.27|0.037
71776060|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.015|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.015
71776061|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||0.07|-0.22||||0.001|TWO_SIDED|95.0|-0.35|-0.08|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.08|-0.35|0.001
71662843|NCT02792699|142838568|OTHER||Risk Difference (RD)|0.0277|||||TWO_SIDED|90.0|-0.0804|0.1357||||||Risk difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.||0.1357|-0.0804|
71776062|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
71776063|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.07||0.042|TWO_SIDED|95.0|-0.27|0.0|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.00|-0.27|0.042
71776064|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.14|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.14|-0.40|<0.001
71776065|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
71776066|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.24|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.24|-0.50|<0.001
71776067|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.182|TWO_SIDED|95.0|-0.22|0.04|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.04|-0.22|0.182
71662844|NCT02792699|142838569|OTHER||LS Mean Difference|-1.999|||||TWO_SIDED|90.0|-7.673|3.675||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.675|-7.673|
71662845|NCT02792699|142838569|OTHER||LS Mean Difference|0.544|||||TWO_SIDED|90.0|-5.185|6.274||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.274|-5.185|
71662846|NCT02792699|142838569|OTHER||LS Mean Difference|-8.224|||||TWO_SIDED|90.0|-14.102|-2.346||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||-2.346|-14.102|
71776068|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.08|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||0.01|-0.25|0.080
71776069|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.34|-0.07|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.07|-0.34|0.002
71833938|NCT04714320|143171966|SUPERIORITY||||||=|0.573||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.573
71833939|NCT04714320|143171966|SUPERIORITY||||||=|0.706||||||Stratification factor (screening eGFR status (\<60 vs ≤ 60 mL/min/1.73 m2)), treatment received and baseline measure were included in Logistic Regression model, firth correction was applied if quasi-complete separation of data points was detected.|Regression, Logistic|||Seated Automated Office SBP ≤ 130 mmHg and DBP ≤ 80 mmHg at Day 169||||=0.706
71662847|NCT02792699|142838569|OTHER||LS Mean Difference|-2.06|||||TWO_SIDED|90.0|-8.052|3.933||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.933|-8.052|
71662848|NCT02792699|142838569|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|90.0|-7.62|4.979||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||4.979|-7.620|
71662849|NCT02792699|142838569|OTHER||LS Mean Difference|0.73|||||TWO_SIDED|90.0|-5.691|7.15||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||7.150|-5.691|
71662850|NCT02792699|142838569|OTHER||LS Mean Difference|-2.207|||||TWO_SIDED|90.0|-8.562|1.417||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||1.417|-8.562|
71740880|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.9|3.0||||||Serotype 3: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.0|-2.9|
71740881|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 5: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71740882|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 6A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71740883|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 7F: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71740884|NCT01200368|142993774|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower confidence interval for the percent difference was \>-0.10.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.7|3.6||||||Serotype 19A: Difference (\[13vPnC + DTaP\] - \[7vPnC + DTaP\]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.||3.6|-1.7|
71740885|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.77|1.15||||||Serotype 4: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.15|0.77|
71662851|NCT02792699|142838569|OTHER||LS Mean Difference|-0.036|||||TWO_SIDED|90.0|-6.497|6.424||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||6.424|-6.497|
71662852|NCT02792699|142838569|OTHER||LS Mean Difference|-6.629|||||TWO_SIDED|90.0|-13.455|0.197||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[EU\]/Rituximab \[EU\]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||0.197|-13.455|
71662853|NCT02792699|142838569|OTHER||LS Mean Difference|-3.096|||||TWO_SIDED|90.0|-9.883|3.691||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab \[US\]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.||3.691|-9.883|
71662854|NCT02792699|142838570|OTHER||Risk Difference (RD)|-0.0245|||||TWO_SIDED|90.0|-0.1083|0.0593|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0593|-0.1083|
71662855|NCT02792699|142838570|OTHER||Risk Difference (RD)|0.0187|||||TWO_SIDED|90.0|-0.061|0.0984|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.|||0.0984|-0.0610|
71662856|NCT03464630|142838575|SUPERIORITY|||||||0.503||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.503
71776070|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|||Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.11|-0.37|<0.001
71776071|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.016|TWO_SIDED|95.0|-0.3|-0.03|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.03|-0.30|0.016
71662857|NCT03464630|142838576|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
71662858|NCT03464630|142838577|SUPERIORITY|||||||0.059||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.059
71662859|NCT03464630|142838578|SUPERIORITY|||||||0.702||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.702
71890854|NCT03093402|143303440|SUPERIORITY||Mean Difference (Final Values)|-21.48||||0.07|TWO_SIDED|95.0|-37.24|-5.72||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||-5.72|-37.24|0.070
71662860|NCT03464630|142838579|SUPERIORITY|||||||0.08||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.08
71776072|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.40|<0.001
71776073|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.42|-0.15|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.15|-0.42|<0.001
71776074|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.27|-0.53|<0.001
71776075|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.29|-0.01|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.01|-0.29|0.032
71776076|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|-0.33|-0.06|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.06|-0.33|0.006
71776077|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.009|TWO_SIDED|95.0|-0.32|-0.05|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.05|-0.32|0.009
71776078|NCT00809354|143051258|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.13|||ANCOVA|||Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.||-0.13|-0.41|<0.001
71776079|NCT00100178|143051302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.47
71776080|NCT02477839|143051309|OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.83|1.14|||ANCOVA|||Difference ratio in LS Mean was calculated as the exp \[LSMLCM-LSMplacebo\].||1.14|0.83|
71776081|NCT02477839|143051309|OTHER||Percent reduction|3.19|||=|0.6895|TWO_SIDED|95.0|-13.59|17.5|||ANCOVA|||Percent reduction over placebo was estimated as 100 x (1-exp \[LSMLCM-LSMPBO\]).||17.50|-13.59|=0.6895
71776082|NCT01439568|143051333|SUPERIORITY||Hazard Ratio (HR)|1.0608||||0.8072|TWO_SIDED|95.0|0.6598|1.7055|||Logrank Test|||||1.7055|0.6598|0.8072
71776083|NCT03198078|143051356|SUPERIORITY||LS mean difference|-5.33||||0.0136|TWO_SIDED|95.0|-9.55|-1.1||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-1.10|-9.55|0.0136
71776084|NCT03198078|143051356|SUPERIORITY||LS mean difference|-6.53||||0.0032|TWO_SIDED|95.0|-10.8|-2.21||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||-2.21|-10.8|0.0032
71833940|NCT04714320|143171967|SUPERIORITY||||||=|0.853||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables|ANCOVA|||Change from Baseline at Day 8||||=0.853
71776085|NCT03198078|143051357|SUPERIORITY||LS mean difference|-1.44||||0.0205|TWO_SIDED|95.0|-2.65|-0.22||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.22|-2.65|0.0205
71833941|NCT04714320|143171967|SUPERIORITY||||||=|0.542||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.542
71662861|NCT03464630|142838580|SUPERIORITY|||||||0.09||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.09
71662862|NCT03464630|142838581|SUPERIORITY|||||||0.898||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.898
71776086|NCT03198078|143051357|SUPERIORITY||LS mean difference|-2.15||||0.0008|TWO_SIDED|95.0|-3.4|-0.91||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Positive Sub-scale Score||-0.91|-3.40|0.0008
71833942|NCT04714320|143171967|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.430
71662863|NCT03464630|142838582|SUPERIORITY|||||||0.349||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||0.349
71662864|NCT03464630|142838583|SUPERIORITY||||||<|0.001||||||P-value is Bonferroni correction adjusted at 0.05|GLM Repeated Measures|||||||<0.001
71662865|NCT01338870|142838606|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.145||0.7606|TWO_SIDED|80.0|-0.08|0.29|||Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.08|0.7606
71662866|NCT01338870|142838606|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0266|TWO_SIDED|80.0|-0.46|-0.09|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.46|0.0266
71662867|NCT01338870|142838606|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.044|TWO_SIDED|80.0|-0.42|-0.06|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.06|-0.42|0.0440
71662868|NCT01338870|142838606|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.137||0.0001|TWO_SIDED|80.0|-0.71|-0.36|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.71|0.0001
71662869|NCT01338870|142838606|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.0013|TWO_SIDED|80.0|-0.6|-0.25|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.25|-0.60|0.0013
71662870|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-5.21|STANDARD_ERROR_OF_MEAN|5.7||0.3611|TWO_SIDED|95.0|-16.4|5.98|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.98|-16.40|0.3611
71662871|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-9.45|STANDARD_ERROR_OF_MEAN|5.686||0.0969|TWO_SIDED|95.0|-20.61|1.71|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.71|-20.61|0.0969
71662872|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|5.71||0.1566|TWO_SIDED|95.0|-19.3|3.11|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.11|-19.30|0.1566
71662873|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-15.92|STANDARD_ERROR_OF_MEAN|5.678||0.0052|TWO_SIDED|95.0|-27.06|-4.77|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.77|-27.06|0.0052
71662874|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-21.09|STANDARD_ERROR_OF_MEAN|5.712||0.0002|TWO_SIDED|95.0|-32.3|-9.88|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-9.88|-32.30|0.0002
71662875|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|5.852||0.9893|TWO_SIDED|95.0|-11.41|11.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.56|-11.41|0.9893
71662876|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.814||0.4767|TWO_SIDED|95.0|-15.55|7.27|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.27|-15.55|0.4767
71662877|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-2.87|STANDARD_ERROR_OF_MEAN|5.816||0.6222|TWO_SIDED|95.0|-14.28|8.55|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.55|-14.28|0.6222
71662878|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-13.88|STANDARD_ERROR_OF_MEAN|5.744||0.0159|TWO_SIDED|95.0|-25.16|-2.61|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.61|-25.16|0.0159
71662879|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-18.69|STANDARD_ERROR_OF_MEAN|5.735||0.0012|TWO_SIDED|95.0|-29.95|-7.44|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.44|-29.95|0.0012
71662880|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|3.86|STANDARD_ERROR_OF_MEAN|5.895||0.5125|TWO_SIDED|95.0|-7.71|15.43|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||15.43|-7.71|0.5125
71662881|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|5.815||0.1455|TWO_SIDED|95.0|-19.89|2.94|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.94|-19.89|0.1455
71662882|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|5.794||0.8712|TWO_SIDED|95.0|-10.43|12.31|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.31|-10.43|0.8712
71662883|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-19.57|STANDARD_ERROR_OF_MEAN|5.707||0.0006|TWO_SIDED|95.0|-30.77|-8.36|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.36|-30.77|0.0006
71662884|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-19.08|STANDARD_ERROR_OF_MEAN|5.696||0.0008|TWO_SIDED|95.0|-30.26|-7.9|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.90|-30.26|0.0008
71662885|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|6.99|STANDARD_ERROR_OF_MEAN|6.055||0.2488|TWO_SIDED|95.0|-4.9|18.87|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.87|-4.90|0.2488
71662886|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-7.56|STANDARD_ERROR_OF_MEAN|6.004||0.2084|TWO_SIDED|95.0|-19.34|4.23|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.23|-19.34|0.2084
71662887|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|5.971||0.9053|TWO_SIDED|95.0|-11.01|12.43|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.43|-11.01|0.9053
71662888|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.853||0.0091|TWO_SIDED|95.0|-26.79|-3.81|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.81|-26.79|0.0091
71662889|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-18.62|STANDARD_ERROR_OF_MEAN|5.875||0.0016|TWO_SIDED|95.0|-30.15|-7.09|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.09|-30.15|0.0016
71662890|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.217||0.2963|TWO_SIDED|95.0|-5.71|18.7|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||18.70|-5.71|0.2963
71662891|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-9.71|STANDARD_ERROR_OF_MEAN|6.17||0.1159|TWO_SIDED|95.0|-21.82|2.4|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.40|-21.82|0.1159
71740886|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.23|||||TWO_SIDED|95.0|0.98|1.53||||||Serotype 6B: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.53|0.98|
71740887|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.81|||||TWO_SIDED|95.0|0.67|0.98||||||Serotype 9V: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||0.98|0.67|
71740888|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.81|1.12||||||Serotype 14: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.12|0.81|
71740889|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.82|||||TWO_SIDED|95.0|0.67|1.01||||||Serotype 18C: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.01|0.67|
71776087|NCT03198078|143051357|SUPERIORITY||LS mean difference|-0.88||||0.136|TWO_SIDED|95.0|-2.04|0.28||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.28|-2.04|0.1360
71776088|NCT03198078|143051357|SUPERIORITY||LS mean difference|-0.95||||0.1158|TWO_SIDED|95.0|-2.14|0.24||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||Change From Baseline to Week 6 in PANSS Negative Sub-scale Score||0.24|-2.14|0.1158
71776089|NCT03198078|143051358|SUPERIORITY||Ratio of Response Rate|1.55||||0.0111|TWO_SIDED|95.0|1.09|2.2|||Cochran-Mantel-Haenszel|P-value was analyzed by Cochran-Mantel-Haenszel (CMH) general association test controlling for (pooled) centers.||||2.20|1.09|0.0111
71776090|NCT03198078|143051358|SUPERIORITY||Ratio of Response Rate|1.51||||0.0224|TWO_SIDED|95.0|1.06|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.06|0.0224
71776091|NCT03198078|143051359|SUPERIORITY||Ratio of Remission Rate|1.18||||0.4415|TWO_SIDED|95.0|0.77|1.81|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||1.81|0.77|0.4415
71662892|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|6.103||0.4413|TWO_SIDED|95.0|-7.28|16.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||16.68|-7.28|0.4413
71662893|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|5.918||0.0099|TWO_SIDED|95.0|-26.91|-3.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.68|-26.91|0.0099
71662894|NCT01338870|142838607|SUPERIORITY_OR_OTHER||LS mean difference|-14.95|STANDARD_ERROR_OF_MEAN|5.981||0.0126|TWO_SIDED|95.0|-26.69|-3.21|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-3.21|-26.69|0.0126
71662895|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.058||0.1797|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1797
71662896|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.058||0.0234|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.04|-0.19|0.0234
71662897|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.058||0.04|TWO_SIDED|80.0|-0.18|-0.03|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.18|0.0400
71662898|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.057||0.1568|TWO_SIDED|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.13|0.1568
71662899|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.058||0.001|TWO_SIDED|80.0|-0.25|-0.11|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.11|-0.25|0.0010
71662900|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0695|TWO_SIDED|80.0|-0.19|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.01|-0.19|0.0695
71662901|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0636|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0636
71662902|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.069||0.0512|TWO_SIDED|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.20|0.0512
71662903|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.068||0.0051|TWO_SIDED|80.0|-0.26|-0.09|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.26|0.0051
71662904|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.069||0.0009|TWO_SIDED|80.0|-0.3|-0.13|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.30|0.0009
71662905|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.2392|TWO_SIDED|80.0|-0.19|0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.05|-0.19|0.2392
71776092|NCT03198078|143051359|SUPERIORITY||Ratio of Remission Rate|1.48||||0.0472|TWO_SIDED|95.0|1.01|2.16|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH general association test controlling for (pooled) centers.||||2.16|1.01|0.0472
71776093|NCT03198078|143051360|SUPERIORITY||LS mean difference|2.48||||0.0854|TWO_SIDED|95.0|-0.35|5.31||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||5.31|-0.35|0.0854
71662906|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.091||0.0308|TWO_SIDED|80.0|-0.29|-0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.05|-0.29|0.0308
71662907|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.091||0.0019|TWO_SIDED|80.0|-0.38|-0.15|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.38|0.0019
71662908|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.089||0.0034|TWO_SIDED|80.0|-0.36|-0.13|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.13|-0.36|0.0034
71662909|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0002|TWO_SIDED|80.0|-0.44|-0.21|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.44|0.0002
71662910|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.126||0.7854|TWO_SIDED|80.0|-0.06|0.26|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||0.26|-0.06|0.7854
71662911|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.123||0.0778|TWO_SIDED|80.0|-0.33|-0.02|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.02|-0.33|0.0778
71662912|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.122||0.0065|TWO_SIDED|80.0|-0.46|-0.15|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.15|-0.46|0.0065
71662913|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.119||0.0011|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0011
71662914|NCT01338870|142838608|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.121||0.0013|TWO_SIDED|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.||-0.21|-0.52|0.0013
71662915|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.272||0.5636|TWO_SIDED|95.0|-0.69|0.38|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.69|0.5636
71662916|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.271||0.4889|TWO_SIDED|95.0|-0.35|0.72|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.72|-0.35|0.4889
71662917|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.272||0.5849|TWO_SIDED|95.0|-0.68|0.39|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.39|-0.68|0.5849
71662918|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.268||0.5104|TWO_SIDED|95.0|-0.7|0.35|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.70|0.5104
71662919|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.269||0.264|TWO_SIDED|95.0|-0.83|0.23|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-0.83|0.2640
71662920|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.357||0.0464|TWO_SIDED|95.0|-1.42|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.01|-1.42|0.0464
71740890|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.75|||||TWO_SIDED|95.0|1.39|2.21||||||Serotype 19F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||2.21|1.39|
71662921|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.353||0.7107|TWO_SIDED|95.0|-0.83|0.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.56|-0.83|0.7107
71662922|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.352||0.1564|TWO_SIDED|95.0|-1.19|0.19|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-1.19|0.1564
71662923|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.345||0.3834|TWO_SIDED|95.0|-0.98|0.38|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.38|-0.98|0.3834
71662924|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.346||0.1279|TWO_SIDED|95.0|-1.21|0.15|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.15|-1.21|0.1279
71662925|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.339||0.252|TWO_SIDED|95.0|-1.06|0.28|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.28|-1.06|0.2520
71662926|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.336||0.2772|TWO_SIDED|95.0|-0.3|1.03|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.03|-0.30|0.2772
71662927|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.335||0.7038|TWO_SIDED|95.0|-0.79|0.53|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.53|-0.79|0.7038
71662928|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.329||0.2031|TWO_SIDED|95.0|-1.07|0.23|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.23|-1.07|0.2031
71662929|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.33||0.6948|TWO_SIDED|95.0|-0.78|0.52|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.78|0.6948
71740891|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||Serotype 23F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI.||1.07|0.70|
71740892|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.62|||||TWO_SIDED|95.0|1.31|1.99||||||Serotype 1: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.99|1.31|
71740893|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|0.29|||||TWO_SIDED|95.0|0.24|0.35||||||Serotype 3: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||0.35|0.24|
71776094|NCT03198078|143051360|SUPERIORITY||LS mean difference|3.99||||0.0072|TWO_SIDED|95.0|1.09|6.88||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||6.88|1.09|0.0072
71776095|NCT03198078|143051361|SUPERIORITY||LS mean difference|-0.11||||0.3589|TWO_SIDED|95.0|-0.36|0.13||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.13|-0.36|0.3589
71662930|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.421||0.5691|TWO_SIDED|95.0|-1.07|0.59|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.07|0.5691
71662931|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.415||0.3447|TWO_SIDED|95.0|-0.42|1.21|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.21|-0.42|0.3447
71662932|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.5769|TWO_SIDED|95.0|-1.04|0.58|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.58|-1.04|0.5769
71740894|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.28|||||TWO_SIDED|95.0|1.07|1.54||||||Serotype 5: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.54|1.07|
71662933|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.402||0.3599|TWO_SIDED|95.0|-1.16|0.42|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-1.16|0.3599
71662934|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.407||0.46|TWO_SIDED|95.0|-1.1|0.5|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.50|-1.10|0.4600
71662935|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.504||0.4253|TWO_SIDED|95.0|-1.39|0.59|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.59|-1.39|0.4253
71662936|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.497||0.4349|TWO_SIDED|95.0|-0.59|1.37|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.37|-0.59|0.4349
71662937|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.492||0.6697|TWO_SIDED|95.0|-1.18|0.76|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.76|-1.18|0.6697
71662938|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.476||0.5501|TWO_SIDED|95.0|-1.22|0.65|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.65|-1.22|0.5501
71740895|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.76|||||TWO_SIDED|95.0|1.46|2.12||||||Serotype 6A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.12|1.46|
71662939|NCT01338870|142838610|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.484||0.4081|TWO_SIDED|95.0|-1.35|0.55|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.55|-1.35|0.4081
71662940|NCT02871492|142838615|SUPERIORITY|||||||0.4294|||||||Cochran-Mantel-Haenszel|||||||0.4294
71776096|NCT03198078|143051361|SUPERIORITY||LS mean difference|-0.2||||0.1118|TWO_SIDED|95.0|-0.45|0.05||P-value was analyzed by MMRM method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value, and baseline visit interaction as a covariate, and with an unstructured covariance.|MMRM|||||0.05|-0.45|0.1118
71776097|NCT03198078|143051362|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.0287|TWO_SIDED|95.0|-0.56|-0.03|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.03|-0.56|0.0287
71662941|NCT02256436|142838631|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.41648|TWO_SIDED|95.0|0.81|1.19||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - All Participants||1.19|0.81|0.41648
71662942|NCT02256436|142838632|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.00224|TWO_SIDED|95.0|0.59|0.91||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)||0.91|0.59|0.00224
71662943|NCT02256436|142838633|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.26443|TWO_SIDED|95.0|0.68|1.24||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - PD-L1 positive participants||1.24|0.68|0.26443
71662944|NCT02256436|142838634|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.61||||0.00239|TWO_SIDED|95.0|0.43|0.86||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - PD-L1 positive participants||0.86|0.43|0.00239
71662945|NCT02256436|142838635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.23958|TWO_SIDED|95.0|0.61|1.28||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - Strongly PD-L1 positive participants||1.28|0.61|0.23958
71662946|NCT02256436|142838636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.00483|TWO_SIDED|95.0|0.37|0.88||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - Strongly PD-L1 positive participants||0.88|0.37|0.00483
71662947|NCT02256436|142838639|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|17.2||||0.00061|TWO_SIDED|95.0|6.8|29.4||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - Strongly PD-L1 Positive Participants||29.4|6.8|0.00061
71740896|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.26|||||TWO_SIDED|95.0|1.04|1.52||||||Serotype 7F: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||1.52|1.04|
71662948|NCT02256436|142838640|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|15.6||||0.00049|TWO_SIDED|95.0|6.5|25.7||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - PD-L1 Positive Participants||25.7|6.5|0.00049
71662949|NCT02256436|142838641|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|10.0||||0.00068|TWO_SIDED|95.0|3.9|16.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - All Participants||16.2|3.9|0.00068
71662950|NCT02256436|142838642|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.07066|TWO_SIDED|95.0|0.53|1.11||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - Strongly PD-L1 Positive Participants||1.11|0.53|0.07066
71662951|NCT02256436|142838643|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.08745|TWO_SIDED|95.0|0.6|1.1||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - PD-L1 Positive Participants||1.10|0.60|0.08745
71662952|NCT02256436|142838644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.05328|TWO_SIDED|95.0|0.71|1.04||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per mRECIST - All Participants||1.04|0.71|0.05328
71740897|NCT01200368|142993775|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was \>0.5.|GMC ratio|1.85|||||TWO_SIDED|95.0|1.54|2.24||||||Serotype 19A: Ratio of IgG GMCs (\[13vPnC + DTaP\]/\[7vPnC + DTaP\]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.||2.24|1.54|
71740898|NCT01200368|142993776|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71662953|NCT02256436|142838645|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.5||||9e-05|TWO_SIDED|95.0|10.1|34.2||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - Strongly PD-L1 Positive Participants||34.2|10.1|0.00009
71662954|NCT02256436|142838646|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|21.0||||2e-05|TWO_SIDED|95.0|11.1|31.5||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - PD-L1 Positive Participants||31.5|11.1|0.00002
71662955|NCT02256436|142838647|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|13.8||||1e-05|TWO_SIDED|95.0|7.4|20.3||One-sided p-value for testing H0: difference in %=0; H1: difference in %\>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per mRECIST - All Participants||20.3|7.4|0.00001
71662956|NCT00468650|142838662|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.96|STANDARD_DEVIATION|5.19|<|0.001||95.0|10.0|11.93||"Statistical significance will be declared if the p-value is \<0.05.~Change from Baseline: Week 6 (LOCF) minus Baseline"|t-test, 2 sided|single sample t-test||Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.||11.93|10.00|<0.001
71662957|NCT00468650|142838663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.14|STANDARD_DEVIATION|5.21|<|0.001||95.0|6.17|8.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||8.11|6.17|<0.001
71662958|NCT00468650|142838663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.57|STANDARD_DEVIATION|5.43|<|0.001||95.0|9.56|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||11.59|9.56|<0.001
71662959|NCT00468650|142838663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.93|STANDARD_DEVIATION|5.26|<|0.001||95.0|9.93|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||11.92|9.93|<0.001
71662960|NCT00468650|142838663|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.95|STANDARD_DEVIATION|5.21|<|0.001||95.0|9.97|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 endpoint minus baseline||11.92|9.97|<0.001
71662961|NCT00468650|142838664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.48|STANDARD_DEVIATION|3.97|<|0.001||95.0|2.74|4.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.23|2.74|<0.001
71740899|NCT01200368|142993776|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71740900|NCT01200368|142993776|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71740901|NCT01200368|142993776|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||2.3|-2.4|
71740902|NCT01200368|142993777|SUPERIORITY_OR_OTHER||GMC ratio|1.1|||||TWO_SIDED|95.0|0.97|1.24||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.24|0.97|
71662962|NCT00468650|142838664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.88|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.05|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.71|3.05|<0.001
71662963|NCT00468650|142838664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
71662964|NCT00468650|142838664|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.86|STANDARD_DEVIATION|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05||4.67|3.04|<0.001
71662965|NCT00468650|142838665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.89|STANDARD_DEVIATION|2.4|<|0.001||95.0|1.45|2.34||p-value not adjusted for multiple comparisons. Threshold for significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||2.34|1.45|<0.001
71662966|NCT00468650|142838665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.46|STANDARD_DEVIATION|2.32|<|0.001||95.0|2.02|2.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.89|2.02|<0.001
71662967|NCT00468650|142838665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.13|3.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||3.05|2.13|<0.001
71662968|NCT00468650|142838665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.63|STANDARD_DEVIATION|2.45|<|0.001||95.0|2.17|3.08||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||3.08|2.17|<0.001
71662969|NCT00468650|142838665|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.59|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.14|3.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||3.04|2.14|<0.001
71662970|NCT00468650|142838666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.61|STANDARD_DEVIATION|1.51|<|0.001||95.0|0.32|0.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.89|0.32|<0.001
71662971|NCT00468650|142838666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.75|STANDARD_DEVIATION|1.46|<|0.001||95.0|0.47|1.02||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.02|0.47|<0.001
71662972|NCT00468650|142838666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.01|0.47|<0.001
71662973|NCT00468650|142838666|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.74|STANDARD_DEVIATION|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.01|0.47|<0.001
71662974|NCT00468650|142838667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.43|STANDARD_DEVIATION|1.87|<|0.001||95.0|1.09|1.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||1.78|1.09|<0.001
71776098|NCT03198078|143051362|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0184|TWO_SIDED|95.0|-0.62|-0.06|||Cochran-Mantel-Haenszel|P-value was analyzed by CMH row mean scores differ test controlling for study center.||||-0.06|-0.62|0.0184
71662975|NCT00468650|142838667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.86|<|0.001||95.0|1.65|2.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||2.35|1.65|<0.001
71662976|NCT00468650|142838667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.89|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||2.62|1.89|<0.001
71776099|NCT03198078|143051373|SUPERIORITY||LS mean difference|0.07|||||TWO_SIDED|95.0|-0.24|0.39|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.39|-0.24|
71662977|NCT00468650|142838667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.26|STANDARD_DEVIATION|1.94|<|0.001||95.0|1.9|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||2.62|1.90|<0.001
71662978|NCT00468650|142838667|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.28|STANDARD_DEVIATION|1.93|<|0.001||95.0|1.91|2.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||2.64|1.91|<0.001
71776100|NCT03198078|143051373|SUPERIORITY||LS mean difference|0.18|||||TWO_SIDED|95.0|-0.14|0.51|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.51|-0.14|
71776101|NCT03198078|143051374|SUPERIORITY||LS mean difference|-0.06|||||TWO_SIDED|95.0|-0.3|0.18|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.18|-0.30|
71662979|NCT00468650|142838668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.55|STANDARD_DEVIATION|1.41|<|0.001||95.0|0.29|0.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||0.82|0.29|<0.001
71662980|NCT00468650|142838668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.81|STANDARD_DEVIATION|1.47|<|0.001||95.0|0.53|1.09||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.09|0.53|<0.001
71740903|NCT01200368|142993777|SUPERIORITY_OR_OTHER||GMC ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.06|0.77|
71740904|NCT01200368|142993778|SUPERIORITY_OR_OTHER||GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.10|0.87|
71740905|NCT01200368|142993778|SUPERIORITY_OR_OTHER||GMC ratio|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||1.05|0.81|
71740906|NCT01200368|142993779|SUPERIORITY_OR_OTHER||GMC ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.||1.15|0.88|
71740907|NCT01200368|142993779|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.85|1.19||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.||1.19|0.85|
71740908|NCT01200368|142993780|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.84|1.11||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.||1.11|0.84|
71740909|NCT01200368|142993780|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.||0.91|0.70|
71740910|NCT00570310|142993789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.003||90.0|-2.25|-0.6||1-sided, alpha = 0.05|ANOVA||Primary Hypothesis: In 'primary responder population', pregabalin is superior to placebo in maintaining pain control measured by change (3-day average: end of the randomization period versus end of maintenance period) in evening pain intensity.|||-0.60|-2.25|0.003
71740911|NCT00570310|142993790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.67|||<|0.001||95.0|5.26|10.08||1-sided, alpha = 0.05|ANOVA|||||10.08|5.26|<0.001
71662981|NCT00468650|142838668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.11|0.55|<0.001
71662982|NCT00468650|142838668|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83|STANDARD_DEVIATION|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.11|0.55|<0.001
71662983|NCT00468650|142838669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.18|STANDARD_DEVIATION|2.42|<|0.001||95.0|2.73|3.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.63|2.73|<0.001
71662984|NCT00468650|142838669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.38|STANDARD_DEVIATION|2.39|<|0.001||95.0|3.94|4.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.83|3.94|<0.001
71740912|NCT00108862|142993791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|3.0||0.45|TWO_SIDED|95.08|-2.0|8.0||The analysis was stratified by screening CD4 (\<50 cells/mm3 vs =\>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided|A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.|The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.||8|-2|0.45
71740913|NCT00108862|142993792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.0||0.02|TWO_SIDED|95.08|2.0|21.0||Interim reviews employed group sequential monitoring using an\> O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||21|2|0.02
71740914|NCT00108862|142993793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.0||0.67|TWO_SIDED|95.08|-7.0|4.0||Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.||4|-7|0.67
71740915|NCT00577824|142993805|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as the covariate.||||||<0.001
71776102|NCT03198078|143051374|SUPERIORITY||LS mean difference|0.11|||||TWO_SIDED|95.0|-0.13|0.36|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.36|-0.13|
71740916|NCT00577824|142993806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
71740917|NCT00577824|142993807|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage|||||||<0.001
71740918|NCT00577824|142993808|SUPERIORITY_OR_OTHER||||||<|0.002||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||<0.002
71740919|NCT00577824|142993809|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA|||||||0.026
71740920|NCT00577824|142993810|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||t-test, 2 sided|||||||0.672
71740921|NCT00577824|142993811|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||t-test, 2 sided|||||||0.580
71662985|NCT00468650|142838669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.73|STANDARD_DEVIATION|2.53|<|0.001||95.0|4.25|5.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.21|4.25|<0.001
71662986|NCT00468650|142838669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.7|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.23|5.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.17|4.23|<0.001
71662987|NCT00468650|142838669|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.72|STANDARD_DEVIATION|2.52|<|0.001||95.0|4.25|5.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.19|4.25|<0.001
71662988|NCT00468650|142838670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.1|<|0.001||95.0|0.8|1.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.59|0.80|<0.001
71662989|NCT00468650|142838670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.2|<|0.001||95.0|1.12|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.95|1.12|<0.001
71662990|NCT00468650|142838670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.95|1.13|<0.001
71662991|NCT00468650|142838670|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.54|STANDARD_DEVIATION|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.95|1.13|<0.001
71662992|NCT00468650|142838671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.73|STANDARD_DEVIATION|2.38|<|0.001||95.0|2.28|3.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.17|2.28|<0.001
71662993|NCT00468650|142838671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.67|STANDARD_DEVIATION|2.49|<|0.001||95.0|3.2|4.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.14|3.20|<0.001
71662994|NCT00468650|142838671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.92|STANDARD_DEVIATION|2.52|<|0.001||95.0|3.44|4.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||4.40|3.44|<0.001
71662995|NCT00468650|142838671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.44|4.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||4.38|3.44|<0.001
71662996|NCT00468650|142838671|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.89|STANDARD_DEVIATION|2.53|<|0.001||95.0|3.42|4.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||4.37|3.42|<0.001
71662997|NCT00468650|142838672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.97|STANDARD_DEVIATION|1.88|<|0.001||95.0|0.62|1.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.32|0.62|<0.001
71662998|NCT00468650|142838672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.21|STANDARD_DEVIATION|1.92|<|0.001||95.0|0.85|1.57||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||1.57|0.85|<0.001
71662999|NCT00468650|142838672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.55|0.84|<0.001
71776103|NCT03198078|143051375|SUPERIORITY||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.09|-0.08|
71663000|NCT00468650|142838672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.55|0.84|<0.001
71663001|NCT00468650|142838673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.71|STANDARD_DEVIATION|25.36|<|0.001||95.0|27.98|37.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||37.43|27.98|<0.001
71663002|NCT00468650|142838673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|46.21|STANDARD_DEVIATION|26.27|<|0.001||95.0|41.29|51.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||51.12|41.29|<0.001
71663003|NCT00468650|142838673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.53|STANDARD_DEVIATION|26.96|<|0.001||95.0|40.44|50.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||50.63|40.44|<0.001
71663004|NCT00468650|142838673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.28|STANDARD_DEVIATION|27.01|<|0.001||95.0|40.25|50.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||50.31|40.25|<0.001
71663005|NCT00468650|142838673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|45.05|STANDARD_DEVIATION|27.02|<|0.001||95.0|39.99|50.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||50.11|39.99|<0.001
71663006|NCT00468650|142838674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.84|STANDARD_DEVIATION|21.1|<|0.001||95.0|9.89|17.79||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||17.79|9.89|<0.001
71663007|NCT00468650|142838674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.07|STANDARD_DEVIATION|24.25|<|0.001||95.0|8.49|17.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||17.65|8.49|<0.001
71663008|NCT00468650|142838674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||17.23|8.14|<0.001
71663009|NCT00468650|142838674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.69|STANDARD_DEVIATION|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||17.23|8.14|<0.001
71663010|NCT00468650|142838675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.41|STANDARD_DEVIATION|4.4|<|0.001||95.0|4.59|6.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||6.23|4.59|<0.001
71663011|NCT00468650|142838675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.85|STANDARD_DEVIATION|4.96|<|0.001||95.0|7.92|9.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||9.78|7.92|<0.001
71663012|NCT00468650|142838675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.21|STANDARD_DEVIATION|5.19|<|0.001||95.0|8.23|10.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||10.19|8.23|<0.001
71663013|NCT00468650|142838675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.28|STANDARD_DEVIATION|5.14|<|0.001||95.0|8.32|10.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||10.24|8.32|<0.001
71663014|NCT00468650|142838675|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.25|STANDARD_DEVIATION|5.15|<|0.001||95.0|8.28|10.22||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||10.22|8.28|<0.001
71776104|NCT03198078|143051375|SUPERIORITY||LS mean difference|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||LS mean difference was analyzed by ANCOVA model, with treatment and study center as main effects and baseline value as covariate.|||0.14|-0.04|
71776105|NCT02607930|143051378|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-0.6|||||TWO_SIDED|95.002|-4.8|3.6|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.6|-4.8|
71776106|NCT02607930|143051378|SUPERIORITY|||||||0.78|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.78
71833943|NCT04714320|143171967|SUPERIORITY||||||=|0.587||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.587
71663015|NCT00468650|142838676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.51|STANDARD_DEVIATION|3.89|<|0.001||95.0|2.78|4.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.24|2.78|<0.001
71663016|NCT00468650|142838676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.41|<|0.001||95.0|3.08|4.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||4.74|3.08|<0.001
71663017|NCT00468650|142838676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.73|3.09|<0.001
71663018|NCT00468650|142838676|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.91|STANDARD_DEVIATION|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.73|3.09|<0.001
71663019|NCT00468650|142838677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.68|STANDARD_DEVIATION|4.86|<|0.001||95.0|5.77|7.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||7.59|5.77|<0.001
71740922|NCT00577824|142993812|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
71740923|NCT00577824|142993813|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.490
71740924|NCT00577824|142993814|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71740925|NCT00577824|142993815|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||t-test, 2 sided|||||||0.208
71740926|NCT00577824|142993817|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||t-test, 2 sided|||||||0.708
71740927|NCT00577824|142993818|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||t-test, 2 sided|||||||0.974
71740928|NCT00577824|142993820|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.200
71740929|NCT00577824|142993821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71740930|NCT00362648|142993829|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|39.3|||<|0.001||95.0|19.1|54.7||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||54.7|19.1|<0.001
71663020|NCT00468650|142838677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.94|STANDARD_DEVIATION|5.21|<|0.001||95.0|8.96|10.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||10.91|8.96|<0.001
71663021|NCT00468650|142838677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.59|STANDARD_DEVIATION|5.08|<|0.001||95.0|9.62|11.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||11.56|9.62|<0.001
71663022|NCT00468650|142838677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.63|STANDARD_DEVIATION|5.03|<|0.001||95.0|9.68|11.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||11.58|9.68|<0.001
71663023|NCT00468650|142838677|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.64|STANDARD_DEVIATION|5.06|<|0.001||95.0|9.68|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||11.59|9.68|<0.001
71663024|NCT00468650|142838678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.29|STANDARD_DEVIATION|4.1|<|0.001||95.0|2.52|4.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.05|2.52|<0.001
71663025|NCT00468650|142838678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.03|STANDARD_DEVIATION|5.09|<|0.001||95.0|3.06|5.0||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.00|3.06|<0.001
71663026|NCT00468650|142838678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||4.96|3.06|<0.001
71663027|NCT00468650|142838678|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||4.96|3.06|<0.001
71663028|NCT00468650|142838679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.79|STANDARD_DEVIATION|2.44|<|0.001||95.0|2.33|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||3.24|2.33|<0.001
71663029|NCT00468650|142838679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.23|STANDARD_DEVIATION|2.56|<|0.001||95.0|3.74|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline||4.71|3.74|<0.001
71663030|NCT00468650|142838679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.74|STANDARD_DEVIATION|2.84|<|0.001||95.0|4.2|5.28||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline||5.28|4.20|<0.001
71663031|NCT00468650|142838679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.78|STANDARD_DEVIATION|2.81|<|0.001||95.0|4.25|5.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline||5.31|4.25|<0.001
71663032|NCT00468650|142838679|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.76|STANDARD_DEVIATION|2.82|<|0.001||95.0|4.23|5.3||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline||5.30|4.23|<0.001
71663033|NCT00468650|142838680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.49|STANDARD_DEVIATION|1.91|<|0.001||95.0|1.13|1.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.85|1.13|<0.001
71663034|NCT00468650|142838680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.96|STANDARD_DEVIATION|2.08|<|0.001||95.0|1.57|2.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.36|1.57|<0.001
71833944|NCT04714320|143171967|SUPERIORITY||||||=|0.91||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.910
71833945|NCT04714320|143171967|SUPERIORITY||||||=|0.846||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.846
71833946|NCT04714320|143171967|SUPERIORITY|||||||0.634||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||0.634
71663035|NCT00468650|142838680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||2.37|1.59|<0.001
71663036|NCT00468650|142838680|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.98|STANDARD_DEVIATION|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||2.37|1.59|<0.001
71663037|NCT00468650|142838681|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|8.84|STANDARD_DEVIATION|28.7||0.0016||95.0|3.42|14.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||14.26|3.42|0.0016
71663038|NCT00468650|142838681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.18|STANDARD_DEVIATION|27.51|<|0.001||95.0|4.93|15.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||15.43|4.93|<0.001
71663039|NCT00468650|142838681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|12.29|STANDARD_DEVIATION|28.88|<|0.001||95.0|6.7|17.88||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||17.88|6.70|<0.001
71663040|NCT00468650|142838681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.96|STANDARD_DEVIATION|28.33|<|0.001||95.0|6.61|17.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||17.32|6.61|<0.001
71663041|NCT00468650|142838681|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|11.95|STANDARD_DEVIATION|28.55|<|0.001||95.0|6.51|17.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||17.40|6.51|<0.001
71663042|NCT00468650|142838682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.37|STANDARD_DEVIATION|14.85||0.3324||95.0|-1.42|4.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||4.17|-1.42|0.3324
71663043|NCT00468650|142838682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.12|STANDARD_DEVIATION|14.26||0.0249||95.0|0.4|5.84||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||5.84|0.40|0.0249
71663044|NCT00468650|142838682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.98|STANDARD_DEVIATION|13.95||0.0249||95.0|0.37|5.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||5.58|0.37|0.0249
71663045|NCT00468650|142838682|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.04|STANDARD_DEVIATION|14.07||0.0249||95.0|0.39|5.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||5.68|0.39|0.0249
71663046|NCT00468650|142838683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.37|STANDARD_DEVIATION|30.51|<|0.001||95.0|9.38|21.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||21.36|9.38|<0.001
71663047|NCT00468650|142838683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.15|STANDARD_DEVIATION|32.22|<|0.001||95.0|10.76|23.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||23.55|10.76|<0.001
71663048|NCT00468650|142838683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.22|STANDARD_DEVIATION|32.44|<|0.001||95.0|11.68|24.76||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||24.76|11.68|<0.001
71663049|NCT00468650|142838683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.33|STANDARD_DEVIATION|31.87|<|0.001||95.0|11.07|23.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||23.59|11.07|<0.001
71663050|NCT00468650|142838683|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.68|STANDARD_DEVIATION|32.1|<|0.001||95.0|11.31|24.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||24.04|11.31|<0.001
71663051|NCT00468650|142838684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.46|STANDARD_DEVIATION|9.41||0.1061||95.0|-0.32|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||3.24|-0.32|0.1061
71776107|NCT02607930|143051379|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-6.9|3.1|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.1|-6.9|
71776108|NCT02607930|143051379|OTHER|||||||0.45|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.45
71663052|NCT00468650|142838684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.18|STANDARD_DEVIATION|12.33||0.3237||95.0|-1.18|3.54||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||3.54|-1.18|0.3237
71663053|NCT00468650|142838684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.13|STANDARD_DEVIATION|12.05||0.3236||95.0|-1.13|3.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||3.38|-1.13|0.3236
71663054|NCT00468650|142838684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.15|STANDARD_DEVIATION|12.16||0.3236||95.0|-1.15|3.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||3.45|-1.15|0.3236
71663055|NCT00468650|142838685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||64.60|49.31|<0.001
71663056|NCT00468650|142838685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
71663057|NCT00468650|142838685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
71663058|NCT00468650|142838685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
71663059|NCT00468650|142838685|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
71663060|NCT00468650|142838686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
71663061|NCT00468650|142838686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
71663062|NCT00468650|142838686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
71663063|NCT00468650|142838686|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
71663064|NCT00468650|142838687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.58|STANDARD_DEVIATION|41.24|<|0.001||95.0|50.48|66.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||66.68|50.48|<0.001
71663065|NCT00468650|142838687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|76.29|STANDARD_DEVIATION|37.21|<|0.001||95.0|68.9|83.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||83.67|68.90|<0.001
71663066|NCT00468650|142838687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|77.69|STANDARD_DEVIATION|37.26|<|0.001||95.0|70.18|85.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||85.21|70.18|<0.001
71663067|NCT00468650|142838687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.79|STANDARD_DEVIATION|36.65|<|0.001||95.0|71.59|85.99||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||85.99|71.59|<0.001
71663068|NCT00468650|142838687|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|78.36|STANDARD_DEVIATION|36.89|<|0.001||95.0|71.04|85.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||85.68|71.04|<0.001
71663069|NCT00468650|142838688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.9|STANDARD_DEVIATION|36.63|<|0.001||95.0|10.98|24.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||24.83|10.98|<0.001
71663070|NCT00468650|142838688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.5|STANDARD_DEVIATION|36.84|<|0.001||95.0|12.44|26.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||26.56|12.44|<0.001
71663071|NCT00468650|142838688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.52|STANDARD_DEVIATION|36.99|<|0.001||95.0|12.59|26.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||26.45|12.59|<0.001
71663072|NCT00468650|142838688|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.88|STANDARD_DEVIATION|37.23|<|0.001||95.0|12.84|26.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||26.91|12.84|<0.001
71663073|NCT00468650|142838689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|57.34|STANDARD_DEVIATION|42.6|<|0.001||95.0|48.93|65.75||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||65.75|48.93|<0.001
71663074|NCT00468650|142838689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.72|STANDARD_DEVIATION|40.3|<|0.001||95.0|62.72|78.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||78.71|62.72|<0.001
71663075|NCT00468650|142838689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.63|STANDARD_DEVIATION|40.78|<|0.001||95.0|62.41|78.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.85|62.41|<0.001
71663076|NCT00468650|142838689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.07|STANDARD_DEVIATION|40.27|<|0.001||95.0|64.16|79.98||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.98|64.16|<0.001
71663077|NCT00468650|142838689|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.51|STANDARD_DEVIATION|40.48|<|0.001||95.0|63.48|79.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||79.55|63.48|<0.001
71663078|NCT00468650|142838690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.1|STANDARD_DEVIATION|29.11|<|0.001||95.0|7.58|18.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||18.63|7.58|<0.001
71663079|NCT00468650|142838690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.11|STANDARD_DEVIATION|32.53|<|0.001||95.0|7.84|20.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.37|7.84|<0.001
71663080|NCT00468650|142838690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.47|STANDARD_DEVIATION|31.92|<|0.001||95.0|7.47|19.47||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||19.47|7.47|<0.001
71663081|NCT00468650|142838690|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.72|STANDARD_DEVIATION|32.16|<|0.001||95.0|7.61|19.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||19.82|7.61|<0.001
71663082|NCT00468650|142838691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|56.96|STANDARD_DEVIATION|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline||64.60|49.31|<0.001
71663083|NCT00468650|142838691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|70.78|STANDARD_DEVIATION|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||77.81|63.74|<0.001
71663084|NCT00468650|142838691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.23|STANDARD_DEVIATION|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||78.45|64.02|<0.001
71663085|NCT00468650|142838691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|72.15|STANDARD_DEVIATION|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||79.11|65.20|<0.001
71663086|NCT00468650|142838691|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|71.6|STANDARD_DEVIATION|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||78.65|64.54|<0.001
71663087|NCT00468650|142838692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.56|STANDARD_DEVIATION|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||19.40|7.72|<0.001
71833947|NCT04714320|143171967|SUPERIORITY||||||=|0.767||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.767
71663088|NCT00468650|142838692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.25|STANDARD_DEVIATION|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||20.25|8.25|<0.001
71663089|NCT00468650|142838692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.51|STANDARD_DEVIATION|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||20.46|8.56|<0.001
71663090|NCT00468650|142838692|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.77|STANDARD_DEVIATION|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||20.82|8.72|<0.001
71663091|NCT00468650|142838693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.58|STANDARD_DEVIATION|37.77||0.001||95.0|-19.96|-5.2||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-5.20|-19.96|0.0010
71663092|NCT00468650|142838693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.55|STANDARD_DEVIATION|35.04|<|0.001||95.0|-27.47|-13.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-13.64|-27.47|<0.001
71663093|NCT00468650|142838693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.53|STANDARD_DEVIATION|36.64|<|0.001||95.0|-29.88|-15.18||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-15.18|-29.88|<0.001
71663094|NCT00468650|142838693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.44|STANDARD_DEVIATION|36.06|<|0.001||95.0|-28.49|-14.39||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-14.39|-28.49|<0.001
71663095|NCT00468650|142838693|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.86|STANDARD_DEVIATION|36.29|<|0.001||95.0|-29.03|-14.7||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-14.70|-29.03|<0.001
71663096|NCT00468650|142838694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.79|STANDARD_DEVIATION|22.58||0.0021||95.0|-11.06|-2.52||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-2.52|-11.06|0.0021
71663097|NCT00468650|142838694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|STANDARD_DEVIATION|23.02||0.0027||95.0|-11.26|-2.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-2.43|-11.26|0.0027
71663098|NCT00468650|142838694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.43|STANDARD_DEVIATION|24.2||0.0015||95.0|-11.97|-2.9||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-2.90|-11.97|0.0015
71663099|NCT00468650|142838694|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.57|STANDARD_DEVIATION|24.4||0.0015||95.0|-12.18|-2.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-2.96|-12.18|0.0015
71663100|NCT00468650|142838695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.87|STANDARD_DEVIATION|34.44||0.0045||95.0|-16.6|-3.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||-3.14|-16.60|0.0045
71663101|NCT00468650|142838695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.74|STANDARD_DEVIATION|32.8|<|0.001||95.0|-18.22|-5.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-5.27|-18.22|<0.001
71663102|NCT00468650|142838695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.78|STANDARD_DEVIATION|33.56|<|0.001||95.0|-19.51|-6.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-6.05|-19.51|<0.001
71663103|NCT00468650|142838695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.13|STANDARD_DEVIATION|33.94|<|0.001||95.0|-19.76|-6.5||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-6.50|-19.76|<0.001
71833948|NCT04714320|143171967|SUPERIORITY||||||=|0.399||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.399
71833949|NCT04714320|143171967|SUPERIORITY||||||=|0.323||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.323
71740931|NCT00362648|142993829|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|48.3|||<|0.001||95.0|22.3|66.1||Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.||66.1|22.3|<0.001
71740932|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|78.3||||||95.0|71.7|84.0||||||Anti-rotavirus IgA||84.0|71.7|
71740933|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|18.5||||||95.0|13.3|24.8||||||Serotype G1||24.8|13.3|
71663104|NCT00468650|142838695|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.4|STANDARD_DEVIATION|33.13|<|0.001||95.0|-18.94|-5.86||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-5.86|-18.94|<0.001
71740934|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|9.0||||||95.0|5.3|14.0||||||Serotype G2||14.0|5.3|
71663105|NCT00468650|142838696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|STANDARD_DEVIATION|22.0||0.2567||95.0|-6.55|1.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||1.77|-6.55|0.2567
71663106|NCT00468650|142838696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.91|STANDARD_DEVIATION|20.73||0.3435||95.0|-5.88|2.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||2.07|-5.88|0.3435
71663107|NCT00468650|142838696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.71|STANDARD_DEVIATION|22.28||0.2||95.0|-6.89|1.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||1.46|-6.89|0.2000
71663108|NCT00468650|142838696|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.76|STANDARD_DEVIATION|22.48||0.2||95.0|-7.01|1.48||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||1.48|-7.01|0.2000
71740935|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|6.3||||||95.0|3.3|10.8||||||Serotype G3||10.8|3.3|
71663109|NCT00468650|142838697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.82|STANDARD_DEVIATION|56.75||0.0558||95.0|-21.91|0.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||0.27|-21.91|0.0558
71740936|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|26.5||||||95.0|20.3|33.3||||||Serotype G4||33.3|20.3|
71740937|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|14.4||||||95.0|9.7|20.2||||||Serotype P1A\[8\]||20.2|9.7|
71740938|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|20.1||||||95.0|14.4|27.0||||||Anti-rotavirus IgA||27.0|14.4|
71663110|NCT00468650|142838697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-29.16|STANDARD_DEVIATION|59.81|<|0.001||95.0|-40.96|-17.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||-17.35|-40.96|<0.001
71663111|NCT00468650|142838697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.79|STANDARD_DEVIATION|60.9|<|0.001||95.0|-43.0|-18.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||-18.58|-43.00|<0.001
71663112|NCT00468650|142838697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.27|STANDARD_DEVIATION|61.7|<|0.001||95.0|-42.33|-18.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||-18.21|-42.33|<0.001
71740939|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.2||||||Serotype G1||2.2|0.0|
71740940|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|1.0|6.8||||||Serotype G2||6.8|1.0|
71740941|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G3||5.9|0.6|
71740942|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G4||5.9|0.6|
71740943|NCT00362648|142993830|SUPERIORITY_OR_OTHER||Percentage|4.7||||||95.0|2.1|9.1||||||Serotype P1A\[8\]||9.1|2.1|
71740944|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|87.8||||||95.0|80.9|92.9||||||Anti-rotavirus IgA||92.9|80.9|
71740945|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|32.1||||||95.0|24.2|40.8||||||Serotype G1||40.8|24.2|
71740946|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|9.9||||||95.0|5.4|16.4||||||Serotype G2||16.4|5.4|
71740947|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|28.2||||||95.0|20.7|36.8||||||Serotype G3||36.8|20.7|
71740948|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|18.3||||||95.0|12.1|26.0||||||Serotype G4||26.0|12.1|
71740949|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|27.5||||||95.0|20.0|36.0||||||Serotype P1A\[8\]||36.0|20.0|
71740950|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|18.2||||||95.0|12.0|25.8||||||Anti-rotavirus IgA||25.8|12.0|
71740951|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|2.3||||||95.0|0.5|6.5||||||Serotype G1||6.5|0.5|
71740952|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|0.8||||||95.0|0.0|4.1||||||Serotype G2||4.1|0.0|
71740953|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|3.0||||||95.0|0.8|7.6||||||Serotype G3||7.6|0.8|
71740954|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|0.0||||||95.0|0.0|2.8||||||Serotype G4||2.8|0.0|
71740955|NCT00362648|142993831|SUPERIORITY_OR_OTHER||Percentage|5.3||||||95.0|2.2|10.6||||||Serotype P1A\[8\]||10.6|2.2|
71740956|NCT01702246|142993861|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||Wilcoxon matched pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.005
71740957|NCT01702246|142993862|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71740958|NCT01702246|142993863|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71833950|NCT04714320|143171967|SUPERIORITY||||||=|0.115||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.115
71663113|NCT00468650|142838697|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-30.87|STANDARD_DEVIATION|60.54|<|0.001||95.0|-42.82|-18.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||-18.92|-42.82|<0.001
71663114|NCT00468650|142838698|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-18.36|STANDARD_DEVIATION|46.03|<|0.001||95.0|-27.05|-9.66||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||-9.66|-27.05|<0.001
71663115|NCT00468650|142838698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.16|STANDARD_DEVIATION|45.24|<|0.001||95.0|-30.84|-13.49||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||-13.49|-30.84|<0.001
71663116|NCT00468650|142838698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.28|STANDARD_DEVIATION|45.86|<|0.001||95.0|-28.87|-11.69||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||-11.69|-28.87|<0.001
71663117|NCT00468650|142838698|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-20.65|STANDARD_DEVIATION|46.2|<|0.001||95.0|-29.38|-11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||-11.92|-29.38|<0.001
71663118|NCT00468650|142838699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|33.27|STANDARD_DEVIATION|41.43|<|0.001||95.0|25.17|41.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||41.36|25.17|<0.001
71663119|NCT00468650|142838699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|61.45|STANDARD_DEVIATION|44.77|<|0.001||95.0|52.61|70.29||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||70.29|52.61|<0.001
71663120|NCT00468650|142838699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|66.1|STANDARD_DEVIATION|45.15|<|0.001||95.0|57.05|75.16||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||75.16|57.05|<0.001
71663121|NCT00468650|142838699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|64.84|STANDARD_DEVIATION|45.7|<|0.001||95.0|55.91|73.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||73.77|55.91|<0.001
71663122|NCT00468650|142838699|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.13|STANDARD_DEVIATION|45.56|<|0.001||95.0|56.14|74.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||74.12|56.14|<0.001
71663123|NCT00468650|142838700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.53|STANDARD_DEVIATION|40.19|<|0.001||95.0|19.94|35.13||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||35.13|19.94|<0.001
71663124|NCT00468650|142838700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.92|STANDARD_DEVIATION|41.9|<|0.001||95.0|22.89|38.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||38.95|22.89|<0.001
71663125|NCT00468650|142838700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.43|STANDARD_DEVIATION|41.88|<|0.001||95.0|22.59|38.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||38.27|22.59|<0.001
71663126|NCT00468650|142838700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|30.98|STANDARD_DEVIATION|42.06|<|0.001||95.0|23.04|38.93||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||38.93|23.04|<0.001
71663127|NCT00468650|142838701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|22.45|STANDARD_DEVIATION|46.1|<|0.001||95.0|13.44|31.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline||31.46|13.44|<0.001
71663128|NCT00468650|142838701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|32.3|STANDARD_DEVIATION|42.15|<|0.001||95.0|23.97|40.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline||40.62|23.97|<0.001
71663129|NCT00468650|142838701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|35.31|STANDARD_DEVIATION|43.52|<|0.001||95.0|26.59|44.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline||44.04|26.59|<0.001
71663130|NCT00468650|142838701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.57|STANDARD_DEVIATION|43.48|<|0.001||95.0|26.07|43.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline||43.07|26.07|<0.001
71663131|NCT00468650|142838701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|34.26|STANDARD_DEVIATION|43.29|<|0.001||95.0|25.72|42.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline||42.81|25.72|<0.001
71663132|NCT00468650|142838702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|9.18|STANDARD_DEVIATION|29.45||0.0014||95.0|3.61|14.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2||14.74|3.61|0.0014
71663133|NCT00468650|142838702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.75|STANDARD_DEVIATION|29.26||0.0025||95.0|3.15|14.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2||14.36|3.15|0.0025
71833951|NCT04714320|143171967|SUPERIORITY||||||=|0.982||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.982
71663134|NCT00468650|142838702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.15|STANDARD_DEVIATION|31.11|<|0.001||95.0|4.32|15.97||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2||15.97|4.32|<0.001
71663135|NCT00468650|142838702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.33|STANDARD_DEVIATION|31.36|<|0.001||95.0|4.41|16.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p\<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2||16.26|4.41|<0.001
71663136|NCT02348723|142838706|SUPERIORITY_OR_OTHER||Risk Difference (RD) %|-5.3||||0.0009|TWO_SIDED|95.0|-8.4|-2.2|||Chi-squared|||The risk difference between dabigatran etexilate vs. warfarin, its 2-sided 95% CI, and corresponding p-value are presented.||-2.2|-8.4|0.0009
71663137|NCT03201965|142838736|SUPERIORITY||Odds Ratio (OR)|5.13|||<|0.0001|TWO_SIDED|95.0|3.22|8.16|||Cochran-Mantel-Haenszel|||||8.16|3.22|<0.0001
71663138|NCT03322930|142838751|OTHER||||||<|0.05||||||calculated from data|t-test, 2 sided||||mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient|||<0.05
71663139|NCT01687244|142838752|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|33.3|||||TWO_SIDED|90.0|16.8|53.6||Not applicable: the primary analysis was a calculation of a confidence interval||||The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion||53.6|16.8|
71663140|NCT01687244|142838752|SUPERIORITY_OR_OTHER||HGRF survival at 12 months|36.8|||||TWO_SIDED|90.0|18.8|58.2|||||The proportion of subjects achieving high-grade recurrence-free survival at 12 months|The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.||58.2|18.8|
71663141|NCT01330420|142838765|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
71663142|NCT01330420|142838766|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.001
71663143|NCT01330420|142838767|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
71663144|NCT01330420|142838769|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention||||<.01
71663145|NCT02373189|142838770|SUPERIORITY|||||||0.05||||||The P-value indicated above is calculated.|paired t-test|means at pre and post treatment were compared within subject.||||||0.05
71663146|NCT02373189|142838771|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71663147|NCT01197755|142838783|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.17||||0.004|TWO_SIDED|95.0|0.05|0.28||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.28|0.05|0.004
71663148|NCT01197755|142838783|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.07||||0.168|TWO_SIDED|95.0|-0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|-0.03|0.168
71663149|NCT01197755|142838784|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.22|||<|0.001|TWO_SIDED|95.0|0.16|0.29|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.29|0.16|<0.001
71663150|NCT01197755|142838785|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.1||||0.014|TWO_SIDED|95.0|0.02|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.02|0.014
71740959|NCT04607837|142993978|SUPERIORITY||Risk Difference (RD)|7.35||||0.2524|TWO_SIDED|95.0|-5.24|19.94|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common risk difference using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the risk difference being 0.||19.94|-5.24|0.2524
71740960|NCT04607837|142993979|SUPERIORITY||Risk Difference (RD)|15.61||||0.0068|TWO_SIDED|95.0|4.31|26.91|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.91|4.31|0.0068
71740961|NCT04607837|142993980|SUPERIORITY||Risk Difference (RD)|8.24||||0.2302|TWO_SIDED|95.0|-5.22|21.71|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.71|-5.22|0.2302
71740962|NCT04607837|142993981|SUPERIORITY||Risk Difference (RD)|7.12||||0.3339|TWO_SIDED|95.0|-7.32|21.55|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||21.55|-7.32|0.3339
71833952|NCT04714320|143171967|SUPERIORITY||||||=|0.859||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.859
71663151|NCT01197755|142838785|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.05||||0.18|TWO_SIDED|95.0|-0.02|0.12||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|-0.02|0.180
71663152|NCT01197755|142838786|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.12|||<|0.001|TWO_SIDED|95.0|0.06|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.19|0.06|<0.001
71663153|NCT01197755|142838786|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.0||||0.891|TWO_SIDED|95.0|-0.04|0.04||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.04|-0.04|0.891
71663154|NCT01197755|142838787|SUPERIORITY_OR_OTHER||Treatment difference|||||0.01||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.010
71663155|NCT01197755|142838787|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.019
71663156|NCT01197755|142838788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.023|TWO_SIDED|95.0|1.21|13.91|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||13.91|1.21|0.023
71663157|NCT01197755|142838788|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.197|TWO_SIDED|95.0|0.65|8.23||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.23|0.65|0.197
71663158|NCT01197755|142838789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.005|TWO_SIDED|95.0|1.54|10.92|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||10.92|1.54|0.005
71833953|NCT04714320|143171967|SUPERIORITY||||||=|0.344||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.344
71663159|NCT01197755|142838789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.002|TWO_SIDED|95.0|1.79|12.3||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||12.30|1.79|0.002
71740963|NCT04607837|142993982|SUPERIORITY||Risk Difference (RD)|0.68||||0.9141|TWO_SIDED|95.0|-11.76|13.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||13.13|-11.76|0.9141
71833954|NCT04714320|143171967|SUPERIORITY||||||=|0.633||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.633
71833955|NCT04714320|143171967|SUPERIORITY||||||=|0.889||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.889
71663160|NCT01197755|142838790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.86|5.76||Nominal p value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||5.76|1.86|<0.001
71663161|NCT01197755|142838790|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.028|TWO_SIDED|95.0|1.07|3.31||Nominal p-value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data||3.31|1.07|0.028
71663162|NCT01197755|142838791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.33|4.45|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.45|1.33|0.004
71663163|NCT01197755|142838791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.186|TWO_SIDED|95.0|0.82|2.79||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.79|0.82|0.186
71663164|NCT01197755|142838792|SUPERIORITY_OR_OTHER|||||||0.729||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.729
71663165|NCT01197755|142838792|SUPERIORITY_OR_OTHER|||||||0.019||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.||||||0.019
71663166|NCT01197755|142838793|SUPERIORITY_OR_OTHER||Treatment difference|2.6||||0.009||95.0|0.65|4.56|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||4.56|0.65|0.009
71663167|NCT01197755|142838793|SUPERIORITY_OR_OTHER||Treatment difference|1.53||||0.118|TWO_SIDED|95.0|-0.39|3.44|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.44|-0.39|0.118
71663168|NCT01197755|142838794|SUPERIORITY_OR_OTHER||Treatment difference|0.67||||0.487||95.0|-1.23|2.58|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.58|-1.23|0.487
71663169|NCT01197755|142838794|SUPERIORITY_OR_OTHER||Treatment difference|0.62||||0.516|TWO_SIDED|95.0|-1.26|2.51|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.51|-1.26|0.516
71663170|NCT00758680|142838796|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|37.63||||0.015|TWO_SIDED|95.0|12.58|62.68|||Mixed Effect Model|||||62.68|12.58|0.015
71663171|NCT00758680|142838796|SUPERIORITY_OR_OTHER||LS Mean Difference on Last Dosing Day|92.3|||<|0.001|TWO_SIDED|95.0|67.56|117.04|||Mixed Effect Model|||||117.04|67.56|<0.001
71663172|NCT01282723|142838800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0093|TWO_SIDED|95.0|1.1|1.95|||Mixed Models Analysis|||"Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®."||1.95|1.10|0.0093
71663173|NCT01282723|142838800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.3204|TWO_SIDED|95.0|0.61|1.17|||Mixed Models Analysis|||"Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®."||1.17|0.61|0.3204
71663174|NCT00371397|142838844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75||||0.009||95.0|||||Regression, Logistic|||hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay's detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.||||.009
71663175|NCT01284621|142838864|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|96.55|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|93.05|100.18|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||100.18|93.05|
71663176|NCT01284621|142838865|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|104.47|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|97.65|111.77|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||111.77|97.65|
71663177|NCT01284621|142838866|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|108.14|STANDARD_DEVIATION|14.0|||TWO_SIDED|90.0|100.51|116.35|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||116.35|100.51|
71663178|NCT01284621|142838867|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|103.61|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|89.73|119.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||119.64|89.73|
71663179|NCT01284621|142838868|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|98.67|STANDARD_DEVIATION|5.2|||TWO_SIDED|90.0|96.0|101.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||101.42|96.00|
71663180|NCT01284621|142838869|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|98.29|STANDARD_DEVIATION|11.3|||TWO_SIDED|90.0|92.67|104.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV|||104.25|92.67|
71663181|NCT02968849|142838913|OTHER||Hazard Ratio (HR)|1.02||||0.84|TWO_SIDED|95.0|0.81|1.3|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.30|0.81|0.84
71833956|NCT04714320|143171967|SUPERIORITY||||||=|0.241||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.241
71663182|NCT02968849|142838913|OTHER||Hazard Ratio (HR)|1.03||||0.83|TWO_SIDED|95.0|0.81|1.31|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.31|0.81|0.83
71663183|NCT02968849|142838924|OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.85|1.28|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.28|0.85|0.66
71663184|NCT02968849|142838924|OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.81|1.23|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.23|0.81|0.98
71663185|NCT02968849|142838926|OTHER||Hazard Ratio (HR)|1.15||||0.39|TWO_SIDED|95.0|0.84|1.58|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.58|0.84|0.39
71663186|NCT02968849|142838926|OTHER||Hazard Ratio (HR)|1.12||||0.5|TWO_SIDED|95.0|0.81|1.54|||Wald||The hazard ratio was estimated using Nelson-Aalen cumulative hazard estimates. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator..|||1.54|0.81|0.50
71663187|NCT02968849|142838937|OTHER||Hazard Ratio (HR)|1.03||||0.82|TWO_SIDED|95.0|0.8|1.33|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.33|0.80|0.82
71663188|NCT02968849|142838938|OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.98|0.50|0.98
71663189|NCT02968849|142838939|OTHER||Hazard Ratio (HR)|1.08||||0.6|TWO_SIDED|95.0|0.8|1.47|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.47|0.80|0.60
71663190|NCT02968849|142838940|OTHER||Hazard Ratio (HR)|0.92||||0.71|TWO_SIDED|95.0|0.58|1.46|||Log Rank|The hazard ratio was tested using a sex-stratified log rank test.|The hazard ratio was estimated using a sex-stratified Cox proportional hazards model. The vaccine group (ALVAC-HIV + subtype C gp120/MF59) represents the numerator and the placebo group represents the denominator.|||1.46|0.58|0.71
71663191|NCT04036799|142838969|OTHER|Categorical variables were summarized using frequencies and proportions.|Cumulative proportion of events at 5 yrs|9.1|||||TWO_SIDED|95.0||||||||||||
71833957|NCT04714320|143171967|SUPERIORITY||||||=|0.367||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.367
71833958|NCT04714320|143171967|SUPERIORITY||||||=|0.716||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.716
71663192|NCT05307510|142838970|SUPERIORITY|Statistical analysis is under powered. N is too low.||||||0.135||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at rest||||0.135
71776109|NCT02607930|143051380|OTHER||Difference in Percentages|-2.6|||||TWO_SIDED|95.0|-8.5|3.4|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.4|-8.5|
71776110|NCT02607930|143051380|OTHER|||||||0.39|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.39
71776111|NCT02607930|143051381|OTHER||Difference in Percentages|0.4|||||TWO_SIDED|95.0|-4.8|5.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.6|-4.8|
71776112|NCT02607930|143051381|OTHER|||||||0.87|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.87
71776113|NCT02607930|143051382|OTHER||Difference in Percentages|-1.2|||||TWO_SIDED|95.0|-6.9|4.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||4.6|-6.9|
71776114|NCT02607930|143051382|OTHER|||||||0.69|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.69
71776115|NCT02607930|143051383|OTHER||Difference in Percentages|-4.2|||||TWO_SIDED|95.0|-10.5|2.1|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||2.1|-10.5|
71776116|NCT02607930|143051383|OTHER|||||||0.19|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.19
71776117|NCT02607930|143051384|OTHER||Difference in LSM|-0.03||||0.48|TWO_SIDED|95.0|-0.12|0.06|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.06|-0.12|0.48
71776118|NCT02607930|143051385|OTHER||Difference in LSM|0.0||||0.99|TWO_SIDED|95.0|-0.09|0.09|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.09|-0.09|0.99
71776119|NCT02607930|143051386|OTHER||Difference in LSM|0.01||||0.88|TWO_SIDED|95.0|-0.08|0.1|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.10|-0.08|0.88
71776120|NCT02607930|143051387|OTHER||Difference in LSM|6.0||||0.69|TWO_SIDED|95.0|-24.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-24|0.69
71776121|NCT02607930|143051388|OTHER||Difference in LSM|-1.0||||0.94|TWO_SIDED|95.0|-39.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||36|-39|0.94
71776122|NCT02607930|143051389|OTHER||Difference in LSM|-20.0||||0.3|TWO_SIDED|95.0|-59.0|18.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||18|-59|0.30
71663193|NCT05307510|142838970|SUPERIORITY|Statistical analysis is underpowered. N is too low||||||0.716||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain at Night||||.716
71776123|NCT02607930|143051390|OTHER||Difference in LSM|0.346||||0.092|TWO_SIDED|95.0|-0.057|0.748|||ANOVA|||||0.748|-0.057|0.092
71776124|NCT02607930|143051391|OTHER||Difference in LSM|0.135||||0.59|TWO_SIDED|95.0|-0.356|0.625|||ANOVA|||||0.625|-0.356|0.59
71776125|NCT02607930|143051392|OTHER||Difference in LSM|0.271||||0.39|TWO_SIDED|95.0|-0.351|0.893|||ANOVA|||||0.893|-0.351|0.39
71776126|NCT02607930|143051393|OTHER||Difference in LSM|-0.221||||0.41|TWO_SIDED|95.0|-0.741|0.3|||ANOVA|||||0.300|-0.741|0.41
71776127|NCT02607930|143051394|OTHER||Difference in LSM|-0.485||||0.14|TWO_SIDED|95.0|-1.126|0.155|||ANOVA|||||0.155|-1.126|0.14
71776128|NCT02607930|143051395|OTHER||Difference in LSM|-0.406||||0.26|TWO_SIDED|95.0|-1.119|0.307|||ANOVA|||||0.307|-1.119|0.26
71663194|NCT05307510|142838970|SUPERIORITY|Statistical Analysis underpowered. N is too small.||||||0.509||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Pain in use||||.509
71663195|NCT05307510|142838971|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71776129|NCT00057876|143051414|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|ONE_SIDED|95.0|||||Log Rank|||Log rank test is conducted for OS to see whether the two treatment arms are different in their overall survival probabilities.||||0.017
71776130|NCT00057876|143051415|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|ONE_SIDED|95.0|||||Log Rank|||||||0.25
71776131|NCT00057876|143051416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Fisher Exact|||Compare objective response rate (CR+PR) between two treatment groups||||0.99
71776132|NCT02083081|143051473|SUPERIORITY|||||||0.38|||||||generalized estimating equations (GEE)|||||||0.38
71776133|NCT02083081|143051474|SUPERIORITY|||||||0.45|||||||generalized estimating equations (GEE)|||||||0.45
71776134|NCT02083081|143051475|SUPERIORITY|||||||0.96|||||||generalized estimating equations (GEE)|||||||0.96
71663196|NCT05307510|142838972|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.635||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Palmar abduction of surgical hand||||.635
71663197|NCT05307510|142838972|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|-3.1||||0.521|TWO_SIDED|95.0|-13.6|7.4|||t-test, 2 sided|||Radial Abduction Surgical Hand||7.4|-13.6|.521
71663198|NCT05307510|142838973|SUPERIORITY|Statistical analysis is underpowered. N is too low.|Mean Difference (Net)|7.42||||0.495|TWO_SIDED|95.0|-16.16|32.0|||t-test, 2 sided|||||32.0|-16.16|.495
71663199|NCT05307510|142838974|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.953||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Buttoning Buttons||||.953
71663200|NCT05307510|142838974|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.947||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Lacing and tying a shoe||||.947
71663201|NCT05307510|142838974|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.828||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Opening and closing safety pins||||.828
71663202|NCT05307510|142838974|SUPERIORITY|Statistical analysis is underpowered. N is too low.||||||0.169||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||Managing coins||||.169
71663203|NCT05307510|142838975|SUPERIORITY|Statistical analysis underpowered. N too small.||||||0.917||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.917
71663204|NCT05307510|142838975|SUPERIORITY|Statistical analysis is underpowered. N is too small||||||0.837||||||The threshold for statistical significance was p \< 0.6|t-test, 2 sided|||||||.837
71740964|NCT04607837|142993983|SUPERIORITY||Risk Difference (RD)|9.56||||0.1089|TWO_SIDED|95.0|-2.13|21.25|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.25|-2.13|0.1089
71740965|NCT04607837|142993984|SUPERIORITY||Risk Difference (RD)|11.19||||0.0104|TWO_SIDED|95.0|2.63|19.75|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.75|2.63|0.0104
71663205|NCT02784444|142838982|SUPERIORITY||Odds Ratio (OR)|0.89||||0.747|TWO_SIDED|95.0|0.44|1.81||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||1.81|0.44|0.747
71663206|NCT02784444|142838982|SUPERIORITY||Odds Ratio (OR)|1.22||||0.575|TWO_SIDED|95.0|0.6|2.48||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.48|0.60|0.575
71663207|NCT02784444|142838982|SUPERIORITY||Odds Ratio (OR)|1.64||||0.158|TWO_SIDED|95.0|0.83|3.27||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.27|0.83|0.158
71663208|NCT02784444|142838983|SUPERIORITY||Odds Ratio (OR)|1.09||||0.828|TWO_SIDED|95.0|0.49|2.42||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.42|0.49|0.828
71663209|NCT02784444|142838983|SUPERIORITY||Odds Ratio (OR)|1.5||||0.299|TWO_SIDED|95.0|0.7|3.21||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.21|0.70|0.299
71663210|NCT02784444|142838983|SUPERIORITY||Odds Ratio (OR)|1.82||||0.116|TWO_SIDED|95.0|0.86|3.82||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.82|0.86|0.116
71663211|NCT02784444|142838984|SUPERIORITY||Odds Ratio (OR)|1.19||||0.657|TWO_SIDED|95.0|0.55|2.55||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||2.55|0.55|0.657
71663212|NCT02784444|142838984|SUPERIORITY||Odds Ratio (OR)|1.45||||0.332|TWO_SIDED|95.0|0.69|3.06||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.06|0.69|0.332
71663213|NCT02784444|142838984|SUPERIORITY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.16||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|Regression, Logistic|Models are adjusted for presence of diabetes mellitus, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in response rates between the MSDC-0602K dose and placebo.||3.16|0.72|0.270
71740966|NCT04607837|142993985|SUPERIORITY||Risk Difference (RD)|-1.07||||0.9203|TWO_SIDED|95.0|-22.06|19.92|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||19.92|-22.06|0.9203
71740967|NCT04607837|142993986|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
71663214|NCT02784444|142838985|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.392|TWO_SIDED|95.0|-0.7|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.7|0.392
71663215|NCT02784444|142838985|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.023|TWO_SIDED|95.0|-1.1|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.1|0.023
71663216|NCT02784444|142838985|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.028|TWO_SIDED|95.0|-1.0|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline NAS (0-8).||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-1.0|0.028
71663217|NCT02784444|142838986|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.224|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.224
71663218|NCT02784444|142838986|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.096|TWO_SIDED|95.0|-0.4|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.4|0.096
71663219|NCT02784444|142838986|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.007|TWO_SIDED|95.0|-0.6|-0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline steatosis.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||-0.1|-0.6|0.007
71663220|NCT02784444|142838987|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.488|TWO_SIDED|95.0|-0.1|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.1|0.488
71663221|NCT02784444|142838987|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.291|TWO_SIDED|95.0|-0.3|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.3|0.291
71663222|NCT02784444|142838987|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.595|TWO_SIDED|95.0|-0.2|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline inflammation.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.2|0.595
71663223|NCT02784444|142838988|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.416|TWO_SIDED|95.0|-0.4|0.2||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.2|-0.4|0.416
71663224|NCT02784444|142838988|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.056|TWO_SIDED|95.0|-0.5|0.0||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.0|-0.5|0.056
71663225|NCT02784444|142838988|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.22|TWO_SIDED|95.0|-0.4|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, presence of diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 versus F2/F3, and baseline ballooning.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.4|0.220
71663226|NCT02784444|142838989|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.928|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.3|-0.3|0.928
71740968|NCT04607837|142993987|SUPERIORITY||Risk Difference (RD)|-1.71||||0.9272|TWO_SIDED|95.0|-38.31|34.9|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||34.90|-38.31|0.9272
71740969|NCT04607837|142993988|SUPERIORITY||Risk Difference (RD)|8.49||||0.1726|TWO_SIDED|95.0|-3.71|20.68|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||20.68|-3.71|0.1726
71740970|NCT04607837|142993989|SUPERIORITY||Risk Difference (RD)|18.64||||0.0151|TWO_SIDED|95.0|3.61|33.67|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||33.67|3.61|0.0151
71663227|NCT02784444|142838989|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.244|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.244
71663228|NCT02784444|142838989|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.228|TWO_SIDED|95.0|-0.5|0.1||Statistical testing was two-sided using a significance (alpha) level of 0.05. No adjustment for multiple comparisons.|ANCOVA|Model adjusted by age, sex, diabetes mellitus, Vitamin E ≥ 400 IU, baseline fibrosis F1 vs. F2/F3, and baseline CRN fibrosis staging score.||The null hypothesis is that there is no difference in changes between the MSDC-0602K dose and placebo.||0.1|-0.5|0.228
71663229|NCT04314648|142839016|SUPERIORITY||Odds Ratio (OR)|6.26|||<|0.001|TWO_SIDED|95.0|2.38|16.48|||Regression, Logistic|||||16.48|2.38|<.001
71663230|NCT04314648|142839017|SUPERIORITY||Odds Ratio, log|5.76|||<|0.01|TWO_SIDED|95.0|1.86|17.86|||Regression, Logistic|||||17.86|1.86|<.01
71663231|NCT04314648|142839018|SUPERIORITY||Odds Ratio (OR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||2.64|.21|.64
71663232|NCT04314648|142839019|SUPERIORITY||Odds Ratio (OR)|2.67||||0.35|TWO_SIDED|95.0|0.35|20.51|||Regression, Logistic||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a logistic regression model, adjusted for baseline use.|||20.51|.35|.35
71663233|NCT04314648|142839020|SUPERIORITY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|2.32||0.43|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a linear regression model, adjusted for baseline use.|||||.43
71663234|NCT04314648|142839021|SUPERIORITY||Mean Difference (Net)|2.35|STANDARD_ERROR_OF_MEAN|3.0||0.44|TWO_SIDED||||||Regression, Linear||Main effects of the intervention on this outcome were compared between arms by fitting follow-up values to a liner regression model, adjusted for baseline use.|||||.44
71663235|NCT04314648|142839022|SUPERIORITY||Odds Ratio (OR)|1.19||||0.77|TWO_SIDED|95.0|0.39|3.62|||Regression, Logistic|||||3.62|.39|.77
71776135|NCT02448810|143051476|OTHER||Hazard Ratio (HR)|0.8||||0.246|TWO_SIDED|70.0|0.5|1.1||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.1|0.5|0.246
71776136|NCT02448810|143051476|OTHER||Hazard Ratio (HR)|0.8||||0.354|TWO_SIDED|70.0|0.5|1.4||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).|1.4|0.5|0.354
71776137|NCT02907268|143051488|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71776138|NCT02907268|143051489|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71776139|NCT02907268|143051490|EQUIVALENCE|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71776140|NCT00457366|143051516|OTHER|We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.|||||>|0.05|||||||ANCOVA|||||||>0.05
71663236|NCT00492024|142839032|SUPERIORITY_OR_OTHER|||||||0.189||95.0||||P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|Adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.189
71663237|NCT00492024|142839037|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo||||0.075
71663238|NCT03257865|142839073|SUPERIORITY||Treatment difference|-1.62|||=|0.1011|TWO_SIDED|95.0|-3.56|0.32|||mixed-effect model repeated measure||"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||0.32|-3.56|=0.1011
71663239|NCT04040192|142839088|OTHER|||||||0.0034||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.0034
71663240|NCT04040192|142839090|OTHER|Analysis of covariance (ANCOVA) model included fixed effects of treatment group, age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Least square mean difference|34.59|STANDARD_ERROR_OF_MEAN|16.274||0.0346|TWO_SIDED|95.0|2.53|66.64|||ANCOVA|||||66.64|2.53|0.0346
71663241|NCT04040192|142839091|OTHER||Median Difference (Final Values)|-0.5||||0.0042|TWO_SIDED|95.0|-1.0|0.0||p-value was estimated by Wilcoxon rank sum test stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Wilcoxon (Mann-Whitney)||Median difference and 95%CI were estimated using Hodges-Lehmann method.|||0.00|-1.00|0.0042
71663242|NCT04040192|142839092|OTHER|||||||0.6815||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=3 and \>=3 point reduction in PP NRS||||0.6815
71663243|NCT04040192|142839092|OTHER|||||||0.1518||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Baseline PP NRS \>=4 and \>=4 point reduction in PP NRS||||0.1518
71663244|NCT04040192|142839093|OTHER|||||||0.1933||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization|Log Rank|||||||0.1933
71776141|NCT04856891|143051517|SUPERIORITY||Percent Difference from Placebo|78.4|||<|0.0001|TWO_SIDED|95.0|62.2|89.1|||Fisher Exact|||||89.1|62.2|<0.0001
71776142|NCT04856891|143051518|SUPERIORITY||LSM Difference from Placebo|0.3||||0.8822|TWO_SIDED|95.0|-4.0|4.7|||Mixed Models Analysis|||||4.7|-4.0|0.8822
71776143|NCT04856891|143051519|SUPERIORITY||LSM Difference from Placebo|-74.9|||<|0.0001|TWO_SIDED|95.0|-85.2|-64.7|||ANCOVA|||||-64.7|-85.2|<0.0001
71663245|NCT04040192|142839094|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.3778|||||||Log Rank|||Baseline ORIS Scale \>=3 and \>=3 point reduction||||0.3778
71663246|NCT04040192|142839094|OTHER|p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization||||||0.487|||||||Log Rank|||Baseline ORIS Scale \>=4 and \>=4 point reduction||||0.4870
71663247|NCT04040192|142839095|OTHER|||||||0.1159||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||||||0.1159
71663248|NCT04040192|142839096|OTHER|||||||0.6973||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||DLQI for participants \>=16 years of age||||0.6973
71663249|NCT04040192|142839096|OTHER|||||||0.7456||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Children's DLQI: participants 4-\<16 yrs of age||||0.7456
71663250|NCT04040192|142839097|OTHER|||||||0.0513||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||POEM||||0.0513
71663251|NCT04040192|142839097|OTHER|||||||0.0217||||||p-value was estimated by the log-rank test, stratified by age group, duration of the BID treatment in OL period, and ISGA score at randomization.|Log Rank|||Proxy POEM||||0.0217
71663252|NCT00875797|142839206|NON_INFERIORITY_OR_EQUIVALENCE|t-test||||||0.05|TWO_SIDED|95.0||||p\<0.05|t-test, 2 sided|||||||0.05
71663253|NCT00875797|142839207|NON_INFERIORITY_OR_EQUIVALENCE|χ2 test|percentage of infection|20.0|STANDARD_DEVIATION|10.0||0.05|TWO_SIDED|95.0||||p\<0.05|Chi-squared|2 degrees of freedom||||||0.05
71663254|NCT00875797|142839208|SUPERIORITY_OR_OTHER||percentage of survivers|80.0|||<|0.05||95.0||||p\<0.05|Chi-squared, Corrected|2-degrees of freedom||Chi-square||||<0.05
71663255|NCT01955083|142839213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|16.0|<|0.05|TWO_SIDED|95.0|-14.4|48.4|||Wilcoxon (Mann-Whitney)|||We hypothesized that pillar implant provide a better efficacy in the treatment of snoring than radiofrequency surgery. The sample size was estimated using the primary outcome effects (VAS) in two previously published studies (Friedman 2008; Fang 2004). Using a two-tailed Wilcoxon signed-rank test (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate, we needed at least 14 participants.||48.4|-14.4|<0.05
71776144|NCT04856891|143051520|SUPERIORITY||Percent Difference from Placebo|80.4|||<|0.0001|TWO_SIDED|95.0|64.8|90.6|||Fisher Exact|||||90.6|64.8|<0.0001
71663256|NCT01955083|142839214|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663257|NCT01955083|142839215|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663258|NCT01955083|142839216|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663259|NCT01955083|142839217|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663260|NCT01955083|142839218|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663261|NCT01955083|142839219|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663262|NCT01955083|142839220|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663263|NCT01955083|142839221|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663264|NCT01955083|142839222|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663265|NCT01955083|142839223|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663266|NCT01955083|142839224|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71663267|NCT01955083|142839225|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
71663268|NCT02472223|142839249|SUPERIORITY||Median Difference (Final Values)|90.0||||0.02|TWO_SIDED|||||p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
71663269|NCT03344861|142839262|OTHER|No comparator arm.|Clopper-Pearson (binomial proportion)|0.05|||<|0.05|TWO_SIDED||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion|Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.||||<0.05
71663270|NCT03344861|142839287|OTHER||||||<|0.05|||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.||"All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as reasonable possibility on the CRF (Case Report Form)."||||<0.05
71663271|NCT02151877|142839288|OTHER||||||>|0.05||||||This test applies to the first marker, cardiac troponin I.|t-test, 2 sided|||Null: mean cardiac troponin I changes in the NO group = mean cardiac troponin I changes in the control||||>0.05
71663272|NCT02151877|142839289|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null: NO group fluid balances are the same as the control||||>0.05
71663273|NCT03185013|142839294|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in percentage|11.4||||0.029|TWO_SIDED|95.0|-0.4|21.2|||Miettinen and Nurminen method|||||21.2|-0.4|0.029
71663274|NCT03185013|142839296|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|12.8|||||TWO_SIDED|95.0|-0.6|24.5||||||||24.5|-0.6|
71663275|NCT03185013|142839297|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|18.2|||||TWO_SIDED|95.0|5.1|29.4||||||||29.4|5.1|
71776145|NCT04856891|143051521|SUPERIORITY||Percent Difference from Placebo|43.5|||<|0.0001|TWO_SIDED|95.0|23.5|59.9|||Fisher Exact|||||59.9|23.5|<0.0001
71776146|NCT04856891|143051522|SUPERIORITY||Percent Difference from Placebo|-1.5||||1|TWO_SIDED|95.0|-22.2|18.0|||Fisher Exact|||||18.0|-22.2|1.0000
71776147|NCT04856891|143051523|SUPERIORITY||Percent Difference from Placebo|6.9||||0.4502|TWO_SIDED|95.0|-13.8|26.3|||Fisher Exact|||||26.3|-13.8|0.4502
71663276|NCT03185013|142839298|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|13.5|||||TWO_SIDED|95.0|1.7|23.5||||||||23.5|1.7|
71663277|NCT03185013|142839299|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|11.8|||||TWO_SIDED|95.0|1.5|20.3||||||||20.3|1.5|
71663278|NCT03185013|142839300|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|-1.7|||||TWO_SIDED|95.0|-11.5|10.3||||||||10.3|-11.5|
71663279|NCT03185013|142839301|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in percentage|10.8|||||TWO_SIDED|95.0|-0.5|20.1||||||||20.1|-0.5|
71663280|NCT03185013|142839302|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|224.0|||||TWO_SIDED|95.0|24.0|224.0||||||Week 15: HPV-16 E7||224.0|24.0|
71663281|NCT03185013|142839302|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 36: HPV-16 E7||0.0|0.0|
71663282|NCT03185013|142839302|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|2024.0|||||TWO_SIDED|95.0|2000.0|6050.0||||||Week 15: HPV-18 E7||6050.0|2000.0|
71663283|NCT03185013|142839302|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location Shift|224.0|||||TWO_SIDED|95.0|74.0|674.0||||||Week 36: HPV-18 E7||674.0|74.0|
71663284|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Location shift|11.67|||||TWO_SIDED|95.0|8.33|20.0||||||HPV-16 E6: Week 15||20.00|8.33|
71776148|NCT04856891|143051524|SUPERIORITY||LSM Difference from Placebo|-3.1||||0.6805|TWO_SIDED|95.0|-18.1|11.8|||Mixed Models Analysis|||Weeks 24 Percent Change from Baseline||11.8|-18.1|0.6805
71663285|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
71663286|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.83|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-16 E7: Week 15||15.00|5.00|
71663287|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|7.5|||||TWO_SIDED|95.0|1.67|10.0||||||HPV-16 E7: Week 36||10.00|1.67|
71663288|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|50.83|||||TWO_SIDED|95.0|31.67|66.67||||||HPV-18 E6: Week 15||66.67|31.67|
71663289|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|38.33|||||TWO_SIDED|95.0|18.33|51.67||||||HPV-18 E6: Week 36||51.67|18.33|
71663290|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|14.17|||||TWO_SIDED|95.0|6.67|18.33||||||HPV-18 E7: Week 15||18.33|6.67|
71663291|NCT03185013|142839303|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|10.0|||||TWO_SIDED|95.0|5.0|15.0||||||HPV-18 E7: Week 36||15.00|5.00|
71663292|NCT03185013|142839304|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.025|||||TWO_SIDED|95.0|0.002|0.046||||||Parameter: CD8+CD137+Perforin+||0.046|0.002|
71663293|NCT03185013|142839304|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.011|||||TWO_SIDED|95.0|0.0|0.014||||||Parameter: CD8+CD38+Perforin+||0.014|0.000|
71663294|NCT03185013|142839304|SUPERIORITY|Superiority was concluded if the lower bound of the 95% CI exceeded 0.|Difference in median|0.044|||||TWO_SIDED|95.0|0.017|0.058||||||Parameter: CD8+CD69+Perforin+||0.058|0.017|
71663295|NCT00673387|142839341|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||<0.0001
71663296|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.0002||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0002
71663297|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.0004||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.0004
71663298|NCT00673387|142839341|SUPERIORITY_OR_OTHER||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||<0.0001
71663299|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||||||0.0001
71740971|NCT04607837|142993990|SUPERIORITY||Risk Difference (RD)|5.96||||0.4419|TWO_SIDED|95.0|-9.22|21.13|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||21.13|-9.22|0.4419
71740972|NCT04607837|142993991|SUPERIORITY||Risk Difference (RD)|23.33||||0.0007|TWO_SIDED|95.0|9.78|36.89|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||36.89|9.78|0.0007
71833959|NCT04714320|143171967|SUPERIORITY||||||=|0.21||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.210
71833960|NCT04714320|143171967|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.363
71833961|NCT04714320|143171967|SUPERIORITY||||||=|0.193||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.193
71833962|NCT04714320|143171967|SUPERIORITY||||||=|0.135||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.135
71833963|NCT04714320|143171967|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.867
71833964|NCT04714320|143171967|SUPERIORITY||||||=|0.761||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.761
71833965|NCT04714320|143171967|SUPERIORITY||||||=|0.618||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.618
71833966|NCT04714320|143171967|SUPERIORITY||||||=|0.363||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.363
71663300|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.251||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2510
71663301|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.3433||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3433
71663302|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.4503||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4503
71833967|NCT04714320|143171967|SUPERIORITY||||||=|0.125||||||The stratification factor (screening eGFR status (\<60 vs ≥60 mL/min/1.73 m2)) and treatment received are included in the Van Elteren model as independent variables.|Van Elteren|||Change from Baseline at Day 106||||=0.125
71833968|NCT04714320|143171967|SUPERIORITY||||||=|0.435||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.435
71833969|NCT04714320|143171967|SUPERIORITY||||||=|0.413||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.413
71833970|NCT04714320|143171967|SUPERIORITY||||||=|0.658||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.658
71833971|NCT04714320|143171967|SUPERIORITY||||||=|0.275||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.275
71833972|NCT04714320|143171967|SUPERIORITY||||||=|0.578||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.578
71833973|NCT04714320|143171967|SUPERIORITY||||||=|0.114||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.114
71833974|NCT04714320|143171968|SUPERIORITY||||||=|0.378||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.378
71833975|NCT04714320|143171968|SUPERIORITY||||||=|0.648||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 8||||=0.648
71833976|NCT04714320|143171968|SUPERIORITY||||||=|0.961||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.961
71833977|NCT04714320|143171968|SUPERIORITY||||||=|0.817||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 15||||=0.817
71833978|NCT04714320|143171968|SUPERIORITY||||||=|0.823||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.823
71833979|NCT04714320|143171968|SUPERIORITY||||||=|0.362||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 22||||=0.362
71833980|NCT04714320|143171968|SUPERIORITY||||||=|0.66||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.660
71833981|NCT04714320|143171968|SUPERIORITY||||||=|0.539||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 29||||=0.539
71833982|NCT04714320|143171968|SUPERIORITY||||||=|0.43||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.430
71833983|NCT04714320|143171968|SUPERIORITY||||||=|0.594||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 36||||=0.594
71833984|NCT04714320|143171968|SUPERIORITY||||||=|0.783||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.783
71833985|NCT04714320|143171968|SUPERIORITY||||||=|0.599||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 43||||=0.599
71833986|NCT04714320|143171968|SUPERIORITY||||||=|0.454||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.454
71663303|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.2122||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2122
71833987|NCT04714320|143171968|SUPERIORITY||||||=|0.394||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 50||||=0.394
71833988|NCT04714320|143171968|SUPERIORITY||||||=|0.93||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.930
71833989|NCT04714320|143171968|SUPERIORITY||||||=|0.313||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 57||||=0.313
71833990|NCT04714320|143171968|SUPERIORITY||||||=|0.276||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.276
71833991|NCT04714320|143171968|SUPERIORITY||||||=|0.168||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 64||||=0.168
71833992|NCT04714320|143171968|SUPERIORITY||||||=|0.199||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.199
71833993|NCT04714320|143171968|SUPERIORITY||||||=|0.506||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 71||||=0.506
71833994|NCT04714320|143171968|SUPERIORITY||||||=|0.32||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.320
71833995|NCT04714320|143171968|SUPERIORITY||||||=|0.25||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 78||||=0.250
71833996|NCT04714320|143171968|SUPERIORITY||||||=|0.373||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.373
71833997|NCT04714320|143171968|SUPERIORITY||||||=|0.597||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 85||||=0.597
71833998|NCT04714320|143171968|SUPERIORITY||||||=|0.867||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.867
71833999|NCT04714320|143171968|SUPERIORITY||||||=|0.5||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 92||||=0.500
71663304|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.2232||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.2232
71663305|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.4207||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.4207
71663306|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.5375||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.5375
71663307|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.6633||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%||||0.6633
71663308|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.3667||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3667
71663309|NCT00673387|142839341|SUPERIORITY_OR_OTHER|||||||0.372||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.||||0.3720
71663310|NCT00673387|142839345|SUPERIORITY_OR_OTHER|||||||0.0404|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate||||0.0404
71663311|NCT00673387|142839345|SUPERIORITY_OR_OTHER|||||||0.0265|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0265
71663312|NCT00673387|142839345|SUPERIORITY_OR_OTHER|||||||0.1357|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.1357
71663313|NCT00673387|142839345|SUPERIORITY_OR_OTHER|||||||0.0409|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0409
71663314|NCT00673387|142839345|SUPERIORITY_OR_OTHER|||||||0.0082|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.||||0.0082
71663315|NCT00673387|142839349|SUPERIORITY_OR_OTHER|||||||0.0464|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0464
71663316|NCT00673387|142839349|SUPERIORITY_OR_OTHER|||||||0.0647|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0647
71663317|NCT00673387|142839349|SUPERIORITY_OR_OTHER|||||||0.069|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0690
71740973|NCT04607837|142993992|SUPERIORITY||Risk Difference (RD)|14.99||||0.0128|TWO_SIDED|95.0|3.19|26.79|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights. The 2-sided p-value was used to test the hypothesis of the RD being 0.||26.79|3.19|0.0128
71776149|NCT02038452|143051530|SUPERIORITY||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.48|-0.16|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.16|-0.48|<0.001
71663318|NCT00673387|142839349|SUPERIORITY_OR_OTHER|||||||0.3717|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.3717
71663319|NCT00673387|142839349|SUPERIORITY_OR_OTHER|||||||0.0327|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0327
71663320|NCT00673387|142839350|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0049
71663321|NCT00673387|142839350|SUPERIORITY_OR_OTHER|||||||0.0047|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0047
71663322|NCT00673387|142839350|SUPERIORITY_OR_OTHER|||||||0.0046|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0046
71663323|NCT00673387|142839350|SUPERIORITY_OR_OTHER|||||||0.0257|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0257
71663324|NCT00673387|142839350|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0014
71663325|NCT00673387|142839351|SUPERIORITY_OR_OTHER|||||||0.0222|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0222
71663326|NCT00673387|142839351|SUPERIORITY_OR_OTHER|||||||0.0128|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0128
71663327|NCT00673387|142839351|SUPERIORITY_OR_OTHER|||||||0.0122|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0122
71834000|NCT04714320|143171968|SUPERIORITY||||||=|0.863||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.863
71834001|NCT04714320|143171968|SUPERIORITY||||||=|0.681||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 106||||=0.681
71663328|NCT00673387|142839351|SUPERIORITY_OR_OTHER|||||||0.0073|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0073
71663329|NCT00673387|142839351|SUPERIORITY_OR_OTHER|||||||0.0034|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (\<35 kg/m2, 35 to \<40 kg/m2, ≥40 kg/m2).||||0.0034
71663330|NCT00960115|142839368|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.828|TWO_SIDED|95.0|0.614|1.479||This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05.|Log Rank||Cox proportional hazards regression model|||1.479|0.614|0.828
71663331|NCT01094886|142839372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.5||0.008|TWO_SIDED|95.0|-0.05|0.34|||t-test, 2 sided|||||0.34|-0.05|.008
71663332|NCT01094886|142839373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_DEVIATION|-1.1||0.111|TWO_SIDED|95.0|-2.048|0.219|||t-test, 2 sided|||||0.219|-2.048|0.111
71663333|NCT01094886|142839374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|6.977||0.87|TWO_SIDED|95.0|-2.77|2.35|||t-test, 2 sided|||||2.35|-2.77|0.87
71663334|NCT01094886|142839375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.13|STANDARD_DEVIATION|36.316|<|0.001|TWO_SIDED|95.0|-48.01|-22.26|||t-test, 2 sided|||||-22.26|-48.01|<0.001
71663335|NCT00574912|142839376|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71663336|NCT02629354|142839408|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|113.77|||||TWO_SIDED|90.0|98.99|130.75|||ANOVA||Analysis of variance (ANOVA) with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% confidence interval (CI) was provided.||130.75|98.99|
71663337|NCT02629354|142839409|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|110.16|||||TWO_SIDED|90.0|96.32|125.97|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||125.97|96.32|
71663338|NCT02629354|142839410|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|112.69|||||TWO_SIDED|90.0|98.49|128.94|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||128.94|98.49|
71663339|NCT02629354|142839411|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.36|||||TWO_SIDED|90.0|94.61|100.19|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.19|94.61|
71663340|NCT02629354|142839412|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.47|||||TWO_SIDED|90.0|93.74|99.28|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||99.28|93.74|
71834002|NCT04714320|143171968|SUPERIORITY||||||=|0.262||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.262
71834003|NCT04714320|143171968|SUPERIORITY||||||=|0.645||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 120||||=0.645
71663341|NCT02629354|142839413|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.55|||||TWO_SIDED|90.0|92.57|102.8|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.80|92.57|
71663342|NCT02629354|142839414|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.57|||||TWO_SIDED|90.0|94.5|100.73|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.73|94.50|
71663343|NCT02629354|142839415|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|97.21|||||TWO_SIDED|90.0|92.22|102.46|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||102.46|92.22|
71663344|NCT02629354|142839416|SUPERIORITY_OR_OTHER||Percent Ratio Test/Ref|96.83|||||TWO_SIDED|90.0|93.75|100.01|||ANOVA||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability \[%\] was estimated by the ratios of the geometric means (100\*test/reference \[T/R\]). Additionally, it's two-sided 90% CI was provided.||100.01|93.75|
71663345|NCT02105974|142839473|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034||||0.001|TWO_SIDED|95.0|0.014|0.055|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.055|0.014|0.001
71663346|NCT02105974|142839474|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62||||0.084|TWO_SIDED|95.0|-0.35|5.59|||ANCOVA|||||5.59|-0.35|0.084
71663347|NCT02105974|142839475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.43|0.78||Nominal p-value|Regression, Cox|||||0.78|0.43|<0.001
71663348|NCT02203331|142839522|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.1483|STANDARD_ERROR_OF_MEAN|0.2925||0.3875|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3875
71663349|NCT02203331|142839522|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.2484|STANDARD_ERROR_OF_MEAN|0.2975||0.2676|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.2676
71663350|NCT02203331|142839522|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.1995|STANDARD_ERROR_OF_MEAN|0.2922||0.3211|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3211
71663351|NCT02203331|142839522|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3467|STANDARD_ERROR_OF_MEAN|0.2994||0.1721|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1721
71890855|NCT03093402|143303440|SUPERIORITY||Mean Difference (Final Values)|-10.4||||0.07|TWO_SIDED|95.0|-25.33|4.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for High JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.54|-25.33|0.070
71896344|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|1.274||||0.679|TWO_SIDED|95.0|0.405|4.005||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.005|0.405|0.679
71663352|NCT02203331|142839523|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.2736|STANDARD_ERROR_OF_MEAN|0.2878||0.231|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.231
71663353|NCT02203331|142839523|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.3234|STANDARD_ERROR_OF_MEAN|0.2927||0.1865|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1865
71663354|NCT02203331|142839523|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.3081|STANDARD_ERROR_OF_MEAN|0.2875||0.1955|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1955
71663355|NCT02203331|142839523|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.3781|STANDARD_ERROR_OF_MEAN|0.2944||0.1416|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.1416
71663356|NCT02203331|142839524|SUPERIORITY_OR_OTHER_LEGACY||Emax|0.0081|STANDARD_ERROR_OF_MEAN|0.2832||0.5794|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5794
71663357|NCT02203331|142839524|SUPERIORITY_OR_OTHER_LEGACY||Linear|0.1148|STANDARD_ERROR_OF_MEAN|0.288||0.4301|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.4301
71663358|NCT02203331|142839524|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 1|0.0401|STANDARD_ERROR_OF_MEAN|0.2829||0.5337|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.5337
71663359|NCT02203331|142839524|SUPERIORITY_OR_OTHER_LEGACY||Sigmoidal Emax 2|0.1835|STANDARD_ERROR_OF_MEAN|0.2899||0.3396|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.||||0.3396
71663360|NCT02091466|142839529|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p \< 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.||||<0.05
71663361|NCT03610516|142839543|OTHER|A repeated measures mixed model was fitted with factors for treatment group (CFZ533 or placebo) and visit.|Ratio of geometric means CFZ533/placebo|0.579||||0.0788|TWO_SIDED|95.0|0.267|1.256||one-sided p-value|Repeated measures Mixed Model|||||1.256|0.267|0.0788
71663362|NCT01328379|142839554|SUPERIORITY_OR_OTHER||least squares mean|0.054|STANDARD_ERROR_OF_MEAN|0.0724||0.457|TWO_SIDED|95.0|-0.088|0.196||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.196|-0.088|0.457
71663363|NCT01328379|142839554|SUPERIORITY_OR_OTHER||least squares mean|0.118|STANDARD_ERROR_OF_MEAN|0.0732||0.107|TWO_SIDED|95.0|-0.026|0.262|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.262|-0.026|0.107
71663364|NCT01328379|142839554|SUPERIORITY_OR_OTHER||least squares mean|0.064|STANDARD_ERROR_OF_MEAN|0.0724||0.375|TWO_SIDED|95.0|-0.078|0.207|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3||0.207|-0.078|0.375
71663365|NCT01328379|142839555|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0666||0.832|TWO_SIDED|95.0|-0.145|0.117||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.117|-0.145|0.832
71663366|NCT01328379|142839555|SUPERIORITY_OR_OTHER||Least Squares Mean|0.093|STANDARD_ERROR_OF_MEAN|0.0674||0.167|TWO_SIDED|95.0|-0.039|0.226|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.226|-0.039|0.167
71663367|NCT01328379|142839555|SUPERIORITY_OR_OTHER||Least Squares Mean|0.107|STANDARD_ERROR_OF_MEAN|0.0666||0.108|TWO_SIDED|95.0|-0.024|0.238|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3||0.238|-0.024|0.108
71663368|NCT01328379|142839556|SUPERIORITY_OR_OTHER||Lease Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|2.367||0.866|TWO_SIDED|95.0|-5.05|4.25|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||4.25|-5.05|0.866
71663369|NCT01328379|142839556|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.56|STANDARD_ERROR_OF_MEAN|2.393||0.286|TWO_SIDED|95.0|-7.26|2.15|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3||2.15|-7.26|0.286
71663370|NCT01328379|142839556|SUPERIORITY_OR_OTHER||Least Squares Mean|-2.16|STANDARD_ERROR_OF_MEAN|2.366||0.362|TWO_SIDED|95.0|-6.81|2.49|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 3||2.49|-6.81|0.362
71663371|NCT01328379|142839557|SUPERIORITY_OR_OTHER||Least Squares Mean|0.84|STANDARD_ERROR_OF_MEAN|2.237||0.708|TWO_SIDED|95.0|-3.56|5.24|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||5.24|-3.56|0.708
71663372|NCT01328379|142839557|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.38|STANDARD_ERROR_OF_MEAN|2.258||0.868|TWO_SIDED|95.0|-4.81|4.06|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2||4.06|-4.81|0.868
71663373|NCT01328379|142839557|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.21|STANDARD_ERROR_OF_MEAN|2.236||0.588|TWO_SIDED|95.0|-5.61|3.18|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 2||3.18|-5.61|0.588
71663374|NCT01328379|142839558|SUPERIORITY_OR_OTHER||Least Squares Mean|35.4|STANDARD_ERROR_OF_MEAN|34.57||0.308|TWO_SIDED|95.0|-33.0|103.7|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||103.7|-33.0|0.308
71776150|NCT02038452|143051531|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.53|-0.17|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.17|-0.53|<0.001
71663375|NCT01328379|142839558|SUPERIORITY_OR_OTHER||Least Squares Mean|87.1|STANDARD_ERROR_OF_MEAN|34.9||0.014|TWO_SIDED|95.0|18.2|156.1|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||156.1|18.2|0.014
71776151|NCT02038452|143051532|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.43|-0.09|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.09|-0.43|0.003
71663376|NCT01328379|142839558|SUPERIORITY_OR_OTHER||Least Squares Mean|51.7|STANDARD_ERROR_OF_MEAN|34.21||0.133|TWO_SIDED|95.0|-15.9|119.3|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Six-Minute Walk Distance at visit 2||119.3|-15.9|0.133
71663377|NCT01328379|142839559|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.32|TWO_SIDED|95.0|0.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.1|-0.0|0.320
71663378|NCT01328379|142839559|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.734|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.734
71663379|NCT01328379|142839559|SUPERIORITY_OR_OTHER||Least Squares Mean|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.185|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Average EQ-5D score at Visit 3||0.0|-0.1|0.185
71663380|NCT01328379|142839560|SUPERIORITY_OR_OTHER||Least Squares Mean|-3.4|STANDARD_ERROR_OF_MEAN|1.79||0.055|TWO_SIDED|95.0|-7.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||0.1|-7.0|0.055
71663381|NCT01328379|142839560|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.83||0.53|TWO_SIDED|95.0|-4.7|2.4|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3||2.4|-4.7|0.530
71663382|NCT01328379|142839560|SUPERIORITY_OR_OTHER||Least Squares Mean|2.3|STANDARD_ERROR_OF_MEAN|1.8||0.203|TWO_SIDED|95.0|-1.2|5.8|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in EQ-5D VAS score at Visit 3||5.8|-1.2|0.203
71663383|NCT00660907|142839561|NON_INFERIORITY_OR_EQUIVALENCE|non-inferior margin delta = 0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0569|<|0.0001|TWO_SIDED|95.0|-0.11|0.11||Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||The null hypothesis is given as H0: mean(treat) minus mean(reference) \>= delta versus the alternative HA: mean(treat) minus mean(reference) \< delta (with alpha = 0.025, one-sided)||0.11|-0.11|<0.0001
71663384|NCT00660907|142839562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.65|STANDARD_ERROR_OF_MEAN|0.2483|<|0.0001|TWO_SIDED|95.0|-5.14|-4.17||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0||-4.17|-5.14|<0.0001
71663385|NCT00660907|142839563|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-37.2|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|-42.3|-32.2||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||-32.2|-42.3|<0.0001
71663386|NCT00660907|142839564|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.8|STANDARD_ERROR_OF_MEAN|2.48|<|0.0001|TWO_SIDED|95.0|26.0|35.7||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0||35.7|26.0|<0.0001
71663387|NCT05773794|142839578|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
71776152|NCT02038452|143051533|SUPERIORITY||Mean Difference (Final Values)|-0.97||||0.005|TWO_SIDED|95.0|-1.64|-0.3|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||-0.30|-1.64|0.005
71776153|NCT02038452|143051534|SUPERIORITY||Odds Ratio (OR)|0.44||||0.018|TWO_SIDED|95.0|0.22|0.87|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.87|0.22|0.018
71776154|NCT02038452|143051537|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.5|TWO_SIDED|95.0|-0.11|0.23|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.23|-0.11|0.500
71776155|NCT02038452|143051538|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.21|TWO_SIDED|95.0|-0.07|0.33|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms||The main treatment analyses were based on intention to treat approach||0.33|-0.07|0.21
71663388|NCT05773794|142839578|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|||||||0.366
71663389|NCT05773794|142839578|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71663390|NCT05773794|142839579|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||||||0.016
71663391|NCT05773794|142839579|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71663392|NCT05773794|142839579|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71663393|NCT05773794|142839580|SUPERIORITY|||||||0.0196|||||||t-test, 2 sided|||||||0.0196
71663394|NCT05773794|142839580|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71663395|NCT05773794|142839580|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71663396|NCT02932306|142839603|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
71663397|NCT02932306|142839604|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.||||<0.001
71663398|NCT02932306|142839605|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth's Penalized Likelihood) with factors of treatment group and analysis center.||||<0.001
71663399|NCT04746794|142839656|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
71663400|NCT04746794|142839657|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71663401|NCT03207243|142839663|OTHER||Median Rate Ratio|0.82|||||TWO_SIDED|95.0|0.66|0.99|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||0.99|0.66|
71663402|NCT03207243|142839668|OTHER||Median Rate Ratio|0.71|||||TWO_SIDED|95.0|0.44|1.01|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented|||1.01|0.44|
71663403|NCT03207243|142839669|OTHER|||||||0.044|||||||Log Rank|||||||0.044
71663404|NCT03207243|142839713|OTHER||Percent change|-93.4|||<|0.001|TWO_SIDED|95.0|-94.9|-91.7||Week 4|mixed model repeated measures analysis|||||-91.7|-94.9|<0.001
71663405|NCT03207243|142839713|OTHER||Percent change|-92.9|||<|0.001|TWO_SIDED|95.0|-94.8|-90.3||Week 8|mixed model repeated measures analysis|||||-90.3|-94.8|<0.001
71663406|NCT03207243|142839713|OTHER||Percent change|-93.2|||<|0.001|TWO_SIDED|95.0|-95.4|-90.0||Week 12|mixed model repeated measures analysis|||||-90.0|-95.4|<0.001
71890856|NCT03093402|143303440|SUPERIORITY||Mean Difference (Final Values)|-10.81||||0.07|TWO_SIDED|95.0|-25.78|4.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Patient Global Assessment Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Mean difference in the change from baseline Patient Global Assessment score for Low JBT-101 - Placebo. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -5.27 (-16.11, 5.56).|Each active JBT-101 cohort is compared to placebo.||4.16|-25.78|0.070
71663407|NCT03207243|142839713|OTHER||Percent change|-93.3|||<|0.001|TWO_SIDED|95.0|-95.3|-90.4||Week 16|mixed model repeated measures analysis|||||-90.4|-95.3|<0.001
71663408|NCT03207243|142839714|OTHER||Percent change|2300.4|||<|0.001|TWO_SIDED|95.0|1833.9|2879.3||Week 4|mixed model repeated measures analysis|||||2879.3|1833.9|<0.001
71663409|NCT03207243|142839714|OTHER||Percent change|2507.7|||<|0.001|TWO_SIDED|95.0|1924.2|3259.4||Week 8|mixed model repeated measures analysis|||||3259.4|1924.2|<0.001
71663410|NCT03207243|142839714|OTHER||Percent change|2162.2|||<|0.001|TWO_SIDED|95.0|1489.1|3120.3||Week 12|mixed model repeated measures analysis|||||3120.3|1489.1|<0.001
71663411|NCT03207243|142839714|OTHER||Percent change|2663.0|||<|0.001|TWO_SIDED|95.0|1994.6|3544.8||Week 16|mixed model repeated measures analysis|||||3544.8|1994.6|<0.001
71663412|NCT04623086|142839726|OTHER|Comparison of two groups|Mean Difference (Net)|8.1||||0.14|TWO_SIDED||||||t-test, 2 sided|||For our power calculations, we assumed the true change in TIR to be 0% for the bridging group and 15% for the direct-conversion group, and we assumed a common standard deviation of 15% (meaning the distributions of change in TIR are separated by 1 standard-deviation unit), and thereby obtained that 20 patients in each group would provide 87% power to observe a statistically significant (at the two-sided level of .05) difference in mean change of TIR.||||0.14
71663413|NCT04623086|142839727|OTHER|Comparison of two groups|Mean Difference (Net)|4.1||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71663414|NCT04623086|142839728|OTHER|Comparison of two groups|Mean Difference (Net)|12.1||||0.29|TWO_SIDED||||||t-test, 2 sided|||||||0.29
71663415|NCT04623086|142839729|OTHER|Comparison of two groups|Mean Difference (Net)|-11.9||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||0.015
71663416|NCT04623086|142839730|OTHER||Mean Difference (Net)|0.3||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71663417|NCT04623086|142839731|OTHER|Comparison of two groups|Mean Difference (Net)|2.6||||0.031|TWO_SIDED||||||t-test, 2 sided|||||||0.031
71663418|NCT04623086|142839732|OTHER|Comparison of two groups|Mean Difference (Net)|1.1||||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
71663419|NCT04623086|142839733|OTHER|Comparison of two groups|Mean Difference (Net)|0.0|||>|0.99|TWO_SIDED||||||t-test, 2 sided|||||||>0.99
71663420|NCT00715624|142839734|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.096||0.0002|TWO_SIDED|95.0|-0.55|-0.174||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.174|-0.550|0.0002
71663421|NCT03200912|142839746|EQUIVALENCE|Primary Efficacy Endpoint - AK Complete Clearance Rates at Day 57 (PP and mITT Populations)|Mean Difference (Net)|2.29|||||TWO_SIDED|90.0|-7.55|12.14||||||||12.14|-7.55|
71663422|NCT03421730|142839784|OTHER||Geometric mean ratio (%)|8.69|||||TWO_SIDED||||||||A: n=6; D: n=5||The intra-subject coefficient of variation was 25.33%.|||
71663423|NCT03421730|142839784|OTHER||Geometric mean ratio (%)|28.18|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
71663424|NCT03421730|142839784|OTHER||Geometric mean ratio (%)|59.51|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.|||
71663425|NCT03421730|142839785|OTHER||Geometric mean ratio (%)|13.35|||||TWO_SIDED||||||||A: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%.|||
71663426|NCT03421730|142839785|OTHER||Geometric mean ratio (%)|35.97|||||TWO_SIDED||||||||B: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
71663427|NCT03421730|142839785|OTHER||Geometric mean ratio (%)|76.98|||||TWO_SIDED||||||||C: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%|||
71663428|NCT03421730|142839786|OTHER||Geometric mean ratio (%)|9.55|||||TWO_SIDED||||||||A: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
71663429|NCT03421730|142839786|OTHER||Geometric mean ratio (%)|32.42|||||TWO_SIDED||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
71663430|NCT03421730|142839786|OTHER||Geometric mean ratio (%)|59.75|||||TWO_SIDED||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.|||
71663431|NCT00118534|142839800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.007|TWO_SIDED|95.0|1.22|3.59|||Regression, Logistic|||The target sample size (n=1400)was designed to have 90% power to detect the difference between 6% and 11% prolonged abstinence rates in SCC and IC, respectively, using a 2-sided .05 level Chi-square test. Final enrollment was 943. The recruitment period was not extended because the achieved sample size provided 78% power to detect the hypothesized prolonged abstinence rates, and the study continued to the end of planned follow-up.||3.59|1.22|0.007
71663432|NCT00118534|142839801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.58|3.74|||Regression, Logistic|||||3.74|1.58|<0.001
71663433|NCT01559389|142839842|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_DEVIATION|2.5||0.16|TWO_SIDED|95.0|-1.23|0.21||P-values less than 0.05 were considered statistically significant.|t-test, 2 sided|The method was a paired t-test||The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners||0.21|-1.23|.16
71663434|NCT01559389|142839843|SUPERIORITY||z-score|2.97||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Exact test|The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment|The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.||||.003
71663435|NCT01559389|142839844|SUPERIORITY||z-score|0.89||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups|The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin||||.37
71663436|NCT01346293|142839865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were \> -10%.|Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.7|10.2||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||10.2|0.7|
71663437|NCT01346293|142839865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were \> -10%.|Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|2.5|21.5||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||21.5|2.5|
71663438|NCT01346293|142839865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were \> -10%.|Mean Difference (Final Values)|3.7|||||TWO_SIDED|3.7|-0.2|7.9||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||7.9|-0.2|
71663439|NCT01346293|142839865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were \> -10%.|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|0.9|9.1||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.||9.1|0.9|
71740974|NCT04607837|142993993|SUPERIORITY||Risk Difference (RD)|10.24||||0.1492|TWO_SIDED|95.0|-3.67|24.14|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.14|-3.67|0.1492
71776156|NCT02038452|143051539|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.96|TWO_SIDED|95.0|-0.175|0.166|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||0.166|-0.175|0.96
71663440|NCT01346293|142839866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.68|2.31||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.||2.31|1.68|
71663441|NCT01346293|142839866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.56|||||TWO_SIDED|95.0|1.3|1.88||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.88|1.30|
71663442|NCT01346293|142839866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.51|||||TWO_SIDED|95.0|1.27|1.79||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.79|1.27|
71834004|NCT04714320|143171968|SUPERIORITY||||||=|0.947||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.947
71663443|NCT01346293|142839866|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were \> 2/3.|Mean Difference (Final Values)|1.33|||||TWO_SIDED|95.0|1.12|1.6||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.||1.60|1.12|
71663444|NCT02687217|142839884|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71663445|NCT02687217|142839885|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
71663446|NCT02687217|142839886|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.5
71663447|NCT03898908|142839899|SUPERIORITY|||||||0.015||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and Week 8||||0.015
71663448|NCT03898908|142839900|SUPERIORITY|||||||0.754||||||pValues below 0.05 are considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison between baseline and W24||||0.754
71663449|NCT02639052|142839902|SUPERIORITY_OR_OTHER|||||||0.9704||||||Significance defined a priori as p\<0.05. P-values not adjusted for multiple comparisons.|ANOVA with Repeated Measures|||Baseline assessment of itch VAS after itch induction but prior to Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.9704
71663450|NCT02639052|142839903|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 week (Visit 2) was the first assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
71663451|NCT02639052|142839904|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Statistically significant difference in mean itch VAS between the two treatments (Botox mean=2.45 versus saline mean=3.20, p\<0.0001). Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 month (Visit 3) was the second assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||<0.0001
71663452|NCT02639052|142839905|SUPERIORITY_OR_OTHER|||||||0.0004||||||Statistical significance defined a priori as p\<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|Analyzed using ANOVA with repeated measures to compare treatment (Botox vs saline), time, and interaction effect between treatment \& time||3 months (Visit 4) was the third assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.||||0.0004
71663453|NCT02639052|142839906|SUPERIORITY_OR_OTHER|||||||0.1306||||||Statistical significance defined a priori as p\<0.05.|ANOVA with Repeated Measures|||Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and visit, and interaction effect between treatment and visit.||||0.1306
71663454|NCT02730351|142839907|OTHER||Mean Difference (Final Values)|-1.69||||0.109|TWO_SIDED|95.0|-3.76|0.39||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.39|-3.76|0.109
71663455|NCT02730351|142839908|OTHER||Mean Difference (Final Values)|-2.15||||0.051|TWO_SIDED|95.0|-4.31|0.01||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis|||||0.01|-4.31|0.051
71663456|NCT02730351|142839909|OTHER||Odds Ratio (OR)|1.34||||0.266|TWO_SIDED|95.0|0.8|2.26||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method. Covariates of treatment, sex, age, treatment period, and period baseline FEV1 were included.|Regression, Logistic||12 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.26|0.80|0.266
71663457|NCT02730351|142839909|OTHER||Odds Ratio (OR)|1.37||||0.322|TWO_SIDED|95.0|0.73|2.58||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method|Regression, Logistic||23 hrs: modeling the odds of having FEV1 \>/=95% of pre exercise FEV1 at each of the two time points.|||2.58|0.73|0.322
71663458|NCT02730351|142839910|OTHER||Mean Difference (Final Values)|-0.65||||0.342|TWO_SIDED|95.0|-2.01|0.71||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||12 hrs post-dose|||0.71|-2.01|0.342
71834005|NCT04714320|143171968|SUPERIORITY||||||=|0.665||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 148||||=0.665
71663459|NCT02730351|142839910|OTHER||Mean Difference (Final Values)|-1.75||||0.041|TWO_SIDED|95.0|-3.42|-0.07||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values.|Mixed Models Analysis||23 hrs post-dose|||-0.07|-3.42|0.041
71776157|NCT02038452|143051540|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.055|TWO_SIDED|95.0|-0.02|1.59|||Regression, Linear|Multiple imputation for missing data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||1.59|-0.02|0.055
71834006|NCT04714320|143171968|SUPERIORITY||||||=|0.498||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.498
71834007|NCT04714320|143171968|SUPERIORITY||||||=|0.173||||||The stratification factor (screening eGFR status \[\<60 vs. ≥60 mL/min/1.73 m2\]), treatment received, and baseline measure were included in the ANCOVA model as independent variables.|ANCOVA|||Change from Baseline at Day 169||||=0.173
71834008|NCT03456076|143172059|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.45|||Log Rank|||||0.45|0.13|.0001
71663460|NCT00838435|142839911|OTHER|Coefficient estimates from a random coefficient model and associated p-values.|Slope|-0.5768|||||TWO_SIDED|95.0|-1.6004|0.4468|||||The slope shown above is based on a 2-year window.|A random coefficient model was used to calculate the slope (per year) of FSIQ over the entire study period. Factors in the model included visit and testing sequence, with change in FSIQ score as the dependent variable. Random terms include both intercept and visit. The treatment was considered successful if the lower 95% confidence limit of the mean change excluded a decline of greater than 5 points over a 2-year window.||0.4468|-1.6004|
71663461|NCT04693416|142839980|OTHER|||||||0.252|||||||t-test, 2 sided|||Pre/post scores within arm||||0.252
71663462|NCT04693416|142839981|OTHER|||||||0.546|||||||t-test, 2 sided|||Pre/post score within arm||||0.546
71663463|NCT04693416|142839982|OTHER|||||||0.005|||||||t-test, 2 sided|||Pre/post scores within arm||||0.005
71663464|NCT04693416|142839983|OTHER|||||||0.188|||||||t-test, 2 sided|||Pre/post scores within arm||||0.188
71663465|NCT04693416|142839984|OTHER|||||||0.049|||||||t-test, 2 sided|||Pre/post score within arm||||0.049
71663466|NCT04693416|142839985|OTHER|||||||0.036|||||||t-test, 2 sided|||Pre/post scores within arm||||0.036
71663467|NCT00474266|142839987|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|2.2|||||TWO_SIDED|95.0|0.29|6.78||||||||6.78|0.29|
71663468|NCT00474266|142839987|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.78|1.58||||||||1.58|-0.78|
71663469|NCT00474266|142839987|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.28|||||TWO_SIDED|95.0|-0.79|1.58||||||||1.58|-0.79|
71663470|NCT00474266|142839987|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|1.07||||||||1.07|-1.06|
71663471|NCT00474266|142839988|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.17||||||||3.17|-1.06|
71663472|NCT00474266|142839989|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|4.06|||||TWO_SIDED|95.0|-2.82|12.46||||||||12.46|-2.82|
71663473|NCT00474266|142839990|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥ -10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.06|3.18||||||||3.18|-1.06|
71663474|NCT00474266|142839991|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|3.36|||||TWO_SIDED|95.0|-0.28|9.5||||||||9.5|-0.28|
71663475|NCT01758588|142840035|OTHER||||||||||||||||||A statistical comparison and analysis of the clinical improvement (CI) proportions cannot be made because the sample size (n=5 in treatment arm, n=3 in observation arm) is too small|||
71663476|NCT04428333|142840073|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and Human Papilloma Virus (HPV) status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
71663477|NCT04428333|142840074|SUPERIORITY|Other|Hazard Ratio (HR)|2.16||||0.74|TWO_SIDED|95.0|0.2|23.87||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥ 20 vs 1≤ CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||23.87|0.20|0.740
71663478|NCT04428333|142840075|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
71663479|NCT04428333|142840076|SUPERIORITY|Other|Hazard Ratio (HR)|0.7||||0.284|TWO_SIDED|95.0|0.2|2.43||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.43|0.20|0.284
71663480|NCT04428333|142840079|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-20.8|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-20.8|
71834009|NCT03456076|143172059|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0001|TWO_SIDED|95.0|0.13|0.43|||Log Rank|||||0.43|0.13|.0001
71663481|NCT04428333|142840080|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-21.4|11.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||11.3|-21.4|
71663482|NCT04428333|142840081|OTHER||Difference in Percentage|-4.8|||||TWO_SIDED|95.0|-22.2|13.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.1|-22.2|
71663483|NCT04428333|142840082|OTHER||Difference in Percentage|-5.1|||||TWO_SIDED|95.0|-22.8|13.3||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||13.3|-22.8|
71663484|NCT04428333|142840099|SUPERIORITY|Other|Hazard Ratio (HR)|0.85||||0.329|TWO_SIDED|95.0|0.42|1.71||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.71|0.42|0.329
71663485|NCT04428333|142840100|SUPERIORITY|Other|Hazard Ratio (HR)|0.82||||0.302|TWO_SIDED|95.0|0.4|1.69||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.69|0.40|0.302
71663486|NCT04428333|142840101|SUPERIORITY|Other|Hazard Ratio (HR)|0.96||||0.472|TWO_SIDED|95.0|0.44|2.11||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20 vs. CPS \<1) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||2.11|0.44|0.472
71663487|NCT04428333|142840102|SUPERIORITY|Other|Hazard Ratio (HR)|0.83||||0.335|TWO_SIDED|95.0|0.36|1.9||Nominal p-value was calculated based on the one sided log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and corresponding 2-sided 95% confidence interval was calculated from the cox regression model with Efron's method of tie handling with treatment as a covariate and stratified by PD-L1 expression (CPS≥20 vs 1≤CPS\<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.90|0.36|0.335
71663488|NCT04853992|142840106|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.5||0.277|TWO_SIDED|95.0|-1.69|0.53|||Mixed Models Analysis|||The primary endpoint, change from baseline in post-provocation Urticaria Activity Score (UASprovo) to the end of the treatment period, was compared between treatments with the null hypothesis that they are equal against the alternative that they are different. The primary efficacy endpoint was analysed using a linear mixed model, containing treatment, period and carryover effects, the factor site and additionally the value of UASprovo at baseline as a covariate.||0.53|-1.69|0.277
71890857|NCT03093402|143303441|SUPERIORITY||Median Difference (Final Values)|0.3||||0.979|TWO_SIDED|95.0|-3.38|3.99||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.99|-3.38|0.979
71663489|NCT03582826|142840111|SUPERIORITY|Paired Wilcoxon Signed-Rank Tests|Median Difference (Final Values)|79.0||||0.02|TWO_SIDED|95.0|26.0|163.0||Original p-value for dermatological bacteria was 6e-05. It was adjusted first by applying centered log-ratio (CLR) transformation approach then by false discovery rate (FDR) correction for multiple comparisons by using Benjamini-Hochberg Procedure.|Wilcoxon (Mann-Whitney)|||||163|26|0.02
71740975|NCT04607837|142993994|SUPERIORITY||Risk Difference (RD)|0.18||||0.9774|TWO_SIDED|95.0|-12.18|12.53|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||12.53|-12.18|0.9774
71776158|NCT02038452|143051541|SUPERIORITY||Odds Ratio (OR)|1.12||||0.76|TWO_SIDED|95.0|0.55|2.2|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||2.20|0.55|0.76
71776159|NCT02038452|143051542|SUPERIORITY||Odds Ratio (OR)|1.66||||0.23|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.77|0.73|0.23
71663490|NCT00319982|142840113|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in E' Velocity comparing baseline and final study visits||||0.75
71663491|NCT00319982|142840114|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Fisher Exact|||Adverse Events||||0.99
71663492|NCT00319982|142840115|SUPERIORITY_OR_OTHER||||||>|0.06|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value. p\<0.05 considered statistically significant.|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||>0.06
71663493|NCT00319982|142840116|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in LV End-Diastolic Diameter z-score from baseline to final visit||||<0.001
71663494|NCT00319982|142840118|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Percentage adherent to study medication||||0.08
71663495|NCT00319982|142840119|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||||||0.15
71663496|NCT03480386|142840131|SUPERIORITY|||||||0.0788|||||||t-test, 2 sided|||Daily Light Physical Activity||||0.0788
71663497|NCT03480386|142840131|SUPERIORITY|||||||0.0742|||||||t-test, 2 sided|||Daily Moderate Physical Activity||||0.0742
71663498|NCT03480386|142840132|SUPERIORITY|||||||0.0113|||||||t-test, 2 sided|||||||0.0113
71663499|NCT03480386|142840133|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
71663500|NCT03480386|142840134|SUPERIORITY|||||||0.2216|||||||t-test, 2 sided|||||||0.2216
71663501|NCT03480386|142840135|SUPERIORITY|||||||0.4762|||||||t-test, 2 sided|||||||0.4762
71663502|NCT03480386|142840136|SUPERIORITY|||||||0.0068|||||||t-test, 2 sided|||||||0.0068
71663503|NCT03480386|142840137|SUPERIORITY|||||||0.1548|||||||t-test, 2 sided|||||||0.1548
71663504|NCT04308226|142840156|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71663505|NCT04308226|142840158|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71663506|NCT00618332|142840172|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||t-test, 2 sided|||||||0.372
71663507|NCT00618332|142840173|SUPERIORITY_OR_OTHER|||||||0.775||95.0|||||t-test, 2 sided|||||||0.775
71663508|NCT00618332|142840174|SUPERIORITY_OR_OTHER|||||||0.737||95.0|||||t-test, 2 sided|||||||0.737
71663509|NCT00618332|142840175|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||t-test, 2 sided|||||||0.117
71663510|NCT00618332|142840176|SUPERIORITY_OR_OTHER|||||||0.676||95.0|||||t-test, 2 sided|||||||0.676
71663511|NCT00618332|142840177|SUPERIORITY_OR_OTHER|||||||0.795||95.0|||||t-test, 2 sided|||||||0.795
71663512|NCT00618332|142840178|SUPERIORITY_OR_OTHER|||||||0.638||95.0|||||t-test, 2 sided|||||||0.638
71663513|NCT00618332|142840179|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.800
71663514|NCT00618332|142840180|SUPERIORITY_OR_OTHER|||||||0.968||95.0|||||t-test, 2 sided|||||||0.968
71663515|NCT01056289|142840193|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|1.16|||||TWO_SIDED|95.0|-0.51|2.83|||ANCOVA|||Difference: Placebo versus DVS SR 50 mg||2.83|-0.51|
71663516|NCT01056289|142840193|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|-1.03|2.35|||ANCOVA|||Difference: DVS SR 25 mg versus DVS SR 50 mg||2.35|-1.03|
71663517|NCT01056289|142840193|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was \>2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.88|1.89|||ANCOVA|||Difference: Placebo versus DVS SR 25 mg||1.89|-0.88|
71663518|NCT03323437|142840219|OTHER|two way anova|||||<|0.01|||||||ANOVA|||||||<0.01
71663519|NCT03323437|142840220|OTHER|two way anova||||||0.68|||||||ANOVA|||||||.68
71663520|NCT03323437|142840221|OTHER|two way anova||||||0.03|||||||ANOVA|||||||.03
71663521|NCT03323437|142840222|OTHER|two way anova||||||0.01|||||||ANOVA|||||||.01
71663522|NCT03323437|142840223|OTHER|two sided t test||||||0.59|||||||t-test, 2 sided|||||||.59
71663523|NCT03323437|142840224|OTHER|two sided t test||||||0.45|||||||t-test, 2 sided|||||||.45
71663524|NCT03323437|142840225|OTHER|two way anova||||||0.32|||||||ANOVA|||||||.32
71663525|NCT03323437|142840226|OTHER|two way anova||||||0.6|||||||ANOVA|||||||.60
71663526|NCT03323437|142840227|OTHER|two way anova||||||0.34|||||||ANOVA|||||||.34
71663527|NCT03323437|142840228|OTHER|two way anova||||||0.35|||||||ANOVA|||||||.35
71663528|NCT03323437|142840229|OTHER|fisher's exact||||||0.66|||||||Fisher Exact|||||||.66
71663529|NCT03323437|142840230|OTHER|two sided t test||||||0.04|||||||t-test, 2 sided|||||||.04
71663530|NCT03323437|142840231|OTHER|fisher's exact test||||||1|||||||Fisher Exact|||||||1
71663531|NCT00843479|142840232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71663532|NCT00843479|142840233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
71663533|NCT00843479|142840234|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
71663534|NCT00843479|142840235|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
71663535|NCT00843479|142840236|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
71663536|NCT00843479|142840237|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||>0.05
71663537|NCT01386983|142840242|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.406||||0.0128|TWO_SIDED|95.0|1.297|8.941|||Regression, Cox|||||8.941|1.297|0.0128
71663538|NCT01386983|142840243|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Generalized linear model|Gamma distribution with log-link function was used.||||||0.0002
71663539|NCT00049530|142840244|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||bionomial proportion test|||It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.||||<0.001
71663540|NCT02383810|142840248|SUPERIORITY|The overall hypothesis system was represented by the following pool of partial hypothesis systems: Hok: πGi = πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j HAk: πGi ≠πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j where πG is the probability of absence of Grade ≥2 CID for the Group. Each Ho involved 2 groups.|||||<|0.1||||||Overall alpha level 0.10 was maintained by correction for multiplicity according to Hommel's procedure.|Chi-squared|||Overall null hypothesis: All elsiglutide dose groups had equal proportion of subjects with max Grade≥2 diarrhea and this was equal to the one in the placebo group. This includes 6 individual hypotheses (i.e., 3 to compare each dose group vs. placebo and 3 to compare dose groups vs. each other). Raw p-values from Chi square tests were corrected for multiplicity according to the Hommel's procedure. Each of 6 hypotheses was then evaluated based on corrected p-value at alpha 0.10 (two-sided).||||<0.1
71890858|NCT03093402|143303441|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.979|TWO_SIDED|95.0|-3.13|3.93||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline Physical Function T-score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||3.93|-3.13|0.979
71890859|NCT03093402|143303441|SUPERIORITY||Median Difference (Final Values)|0.77||||0.979|TWO_SIDED|95.0|-2.77|4.31||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Physical Function Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was 1.8 (-0.8, 4.3).|||4.31|-2.77|0.979
71663541|NCT01696058|142840297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.135|||Mixed Model Repeated Measure|||Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).||0.135|0.078|<.0001
71663542|NCT01696058|142840298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.014|0.065|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).||0.065|0.014|0.0029
71663543|NCT01696058|142840299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.854|STANDARD_ERROR_OF_MEAN|0.461|<|0.0001|TWO_SIDED|95.0|-2.757|-0.951|||ANCOVA|||"Results are from ANCOVA model. Fixed effects include study, treatment and baseline.~Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039)."||-0.951|-2.757|<.0001
71663544|NCT01696058|142840300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.071|0.129|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.129|0.071|<.0001
71663545|NCT01696058|142840301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.072|0.164|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.164|0.072|<.0001
71663546|NCT01696058|142840302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.057|0.152|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."||0.152|0.057|<.0001
71740976|NCT04607837|142993995|SUPERIORITY||Risk Difference (RD)|22.83||||0.0011|TWO_SIDED|95.0|9.17|36.49|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||36.49|9.17|0.0011
71663547|NCT01696058|142840303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.022||0.1156|TWO_SIDED|95.0|-0.008|0.076|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550)."||0.076|-0.008|0.1156
71776160|NCT02038452|143051543|SUPERIORITY||Odds Ratio (OR)|1.28||||0.66|TWO_SIDED|95.0|0.41|3.98|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.98|0.41|0.66
71776161|NCT02038452|143051544|SUPERIORITY||Odds Ratio (OR)|1.43||||0.66|TWO_SIDED|95.0|0.28|7.34|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||7.34|0.28|0.66
71663548|NCT01696058|142840304|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|7.237|STANDARD_ERROR_OF_MEAN|2.145||0.0008|TWO_SIDED|95.0|3.028|11.446|||ANCOVA|||"Week 12: Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)."||11.446|3.028|0.0008
71663549|NCT01696058|142840305|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.568|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.8|-0.336|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.336|-0.800|<.0001
71663550|NCT01696058|142840306|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 1|-0.09|STANDARD_ERROR_OF_MEAN|0.045||0.0467|TWO_SIDED|95.0|-0.178|-0.001|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.001|-0.178|0.0467
71663551|NCT01696058|142840307|SUPERIORITY_OR_OTHER||Mean difference from Tio+Placebo Week 12|-0.483|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.668|-0.298|||ANCOVA|||"Week 12 - Results are from non-MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."||-0.298|-0.668|<.0001
71663552|NCT01934335|142840311|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71663553|NCT01934335|142840312|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
71663554|NCT01934335|142840313|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71776162|NCT02038452|143051545|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.18|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||3.18|0.63|0.40
71663555|NCT05384171|142840317|SUPERIORITY||Partial Eta Squared (effect size)|0.02||||0.617|TWO_SIDED||||||ANCOVA|||||||.617
71663556|NCT05384171|142840319|SUPERIORITY||Partial Eta Squared (effect size)|0.089||||0.214|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group intention follow-up means are equal when controlling for covariates (i.e., baseline intention scores and age)||||.214
71663557|NCT05384171|142840319|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.894|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group attitude follow-up means are equal when controlling for covariates (i.e., baseline attitude scores and age)||||.894
71663558|NCT05384171|142840319|SUPERIORITY||Partial Eta Squared (Effect Size)|0.053||||0.359|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group social norms follow-up means are equal when controlling for covariates (i.e., baseline social norms scores and age)||||.359
71663559|NCT05384171|142840319|SUPERIORITY||Partial Eta Squared (Effect Size)|0.058||||0.322|TWO_SIDED||||||ANCOVA|||Null hypothesis: Intervention and active control group perceived behavioral control follow-up means are equal when controlling for covariates (i.e., baseline perceived behavioral control scores and age)||||.322
71663560|NCT05384171|142840320|SUPERIORITY||Partial Eta Squared (effect size)|0.001||||0.891|TWO_SIDED||||||ANCOVA|||||||.891
71663561|NCT00106964|142840322|SUPERIORITY_OR_OTHER|||||||0.044|||||||Chi-squared|||||||0.0440
71663562|NCT00106964|142840322|SUPERIORITY_OR_OTHER|||||||0.0157|||||||Chi-squared|||||||0.0157
71663563|NCT00106964|142840326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.5822||95.0|||||Regression, Cox|||||||0.5822
71663564|NCT00106964|142840326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.8698||95.0|||||Regression, Cox|||||||0.8698
71663565|NCT00106964|142840327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.29||||0.0853|TWO_SIDED|95.0|0.07|1.19|||Regression, Logistic||Adjusted odds ratio (OR) Odds ratio depends on CD4 count resulting from interaction. For example, OR=0.29 for CD4 count = 0; OR= 2.91 for CD4 count = 460 (median CD4 count for the evaluable study population).|||1.19|0.07|0.0853
71663566|NCT00106964|142840327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.0244|TWO_SIDED|95.0|1.09|3.63|||Regression, Logistic||Adjusted odds ratio|||3.63|1.09|0.0244
71663567|NCT00168818|142840331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-0.7||||0.5648||95.0|-2.9|1.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.6|-2.9|0.5648
71776163|NCT02038452|143051546|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2|TWO_SIDED|95.0|0.7|5.66|||Regression, Logistic|Multiple imputation for missing data was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||The main treatment analyses were based on intention to treat approach||5.66|0.70|0.20
71776164|NCT02038452|143051547|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.001|TWO_SIDED|95.0|-0.53|-0.14||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.14|-0.53|0.001
71776165|NCT02038452|143051548|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.74|TWO_SIDED|95.0|-0.17|0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.24|-0.17|0.74
71776166|NCT02038452|143051549|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.12|-0.30|0.41
71776167|NCT02038452|143051550|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.28|-0.16|0.58
71663568|NCT00168818|142840331|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|1.9||||0.1339||95.0|-0.6|4.4||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.4|-0.6|0.1339
71663569|NCT00168818|142840332|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.3256||95.0|-2.5|0.8|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.8|-2.5|0.3256
71663570|NCT00168818|142840332|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.4||||0.7052||95.0|-1.5|2.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.2|-1.5|0.7052
71663571|NCT00168818|142840333|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.1863||95.0|-2.7|0.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||0.5|-2.7|0.1863
71663572|NCT00168818|142840333|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.702||95.0|-1.4|2.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.1|-1.4|0.7020
71663573|NCT00168818|142840334|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.1||||0.3173||95.0|-3.3|1.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.1|-3.3|0.3173
71834010|NCT00431834|143172067|SUPERIORITY_OR_OTHER||binomial proportions|37.7|||<|0.0041|ONE_SIDED|97.5|25.6|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||25.6|<0.0041
71663574|NCT00168818|142840334|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.9||||0.1274||95.0|-0.5|4.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.3|-0.5|0.1274
71663575|NCT00168818|142840335|SUPERIORITY_OR_OTHER|||||||0.0694||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0694
71663576|NCT00168818|142840335|SUPERIORITY_OR_OTHER|||||||0.0212||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0212
71890860|NCT03093402|143303442|SUPERIORITY||Mean Difference (Final Values)|-1.44||||0.788|TWO_SIDED|95.0|-6.14|3.26||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||3.26|-6.14|0.788
71663577|NCT00168818|142840336|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5062
71663578|NCT00168818|142840336|SUPERIORITY_OR_OTHER|||||||0.3717||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.3717
71663579|NCT00168818|142840337|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1240
71663580|NCT00168818|142840337|SUPERIORITY_OR_OTHER|||||||0.2497||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.2497
71663581|NCT00168818|142840339|SUPERIORITY_OR_OTHER|||||||0.4352||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4352
71663582|NCT00168818|142840339|SUPERIORITY_OR_OTHER|||||||0.6037||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.6037
71663583|NCT01994291|142840343|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.32|STANDARD_ERROR_OF_MEAN|1.52||0.1271|TWO_SIDED|80.0|-4.27|-0.37|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.37|-4.27|0.1271
71663584|NCT01994291|142840343|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.48|STANDARD_ERROR_OF_MEAN|1.36||0.0699|TWO_SIDED|80.0|-4.24|-0.73|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.73|-4.24|0.0699
71663585|NCT01994291|142840343|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.41|STANDARD_ERROR_OF_MEAN|1.17||0.0399|TWO_SIDED|80.0|-3.91|-0.91|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||-0.91|-3.91|0.0399
71663586|NCT01994291|142840344|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1416||||0.0218|TWO_SIDED|80.0|-0.2483|-0.0467|||Barnard test|||||-0.0467|-0.2483|0.0218
71663587|NCT01994291|142840344|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0442||||0.4209|TWO_SIDED|80.0|-0.1217|0.0261|||Barnard test.|||baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.||0.0261|-0.1217|0.4209
71663588|NCT01994291|142840344|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0849||||0.0778|TWO_SIDED|80.0|-0.1516|-0.0168|||Barnard test.|||||-0.0168|-0.1516|0.0778
71663589|NCT01994291|142840345|SUPERIORITY_OR_OTHER||Difference in LS means|114.07|STANDARD_ERROR_OF_MEAN|19.84|<|0.0001|TWO_SIDED|80.0|88.56|139.59|||Mixed Models Analysis|||||139.59|88.56|<0.0001
71663590|NCT01994291|142840345|SUPERIORITY_OR_OTHER||Difference in LS means|65.81|STANDARD_ERROR_OF_MEAN|18.36||0.0004|TWO_SIDED|80.0|42.2|89.43|||Mixed Models Analysis|||||89.43|42.20|0.0004
71663591|NCT01994291|142840345|SUPERIORITY_OR_OTHER||Difference in LS means|87.32|STANDARD_ERROR_OF_MEAN|15.44|<|0.0001|TWO_SIDED|80.0|67.45|107.19|||Mixed Models Analysis|||||107.19|67.45|<0.0001
71663592|NCT01994291|142840346|SUPERIORITY_OR_OTHER||Difference in LS means|7.98|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|80.0|6.13|9.83|||ANCOVA|||||9.83|6.13|<0.0001
71663593|NCT01994291|142840346|SUPERIORITY_OR_OTHER||Difference in LS means|6.34|STANDARD_ERROR_OF_MEAN|1.28|<|0.0001|TWO_SIDED|80.0|4.7|7.98|||ANCOVA|||||7.98|4.70|<0.0001
71663594|NCT01994291|142840346|SUPERIORITY_OR_OTHER||Difference in LS means|7.07|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|80.0|5.66|8.48|||ANCOVA|||||8.48|5.66|<0.0001
71890861|NCT03093402|143303442|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.788|TWO_SIDED|95.0|-6.07|2.96||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||2.96|-6.07|0.788
71663595|NCT01994291|142840347|SUPERIORITY_OR_OTHER||Difference in LS means|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.0423|TWO_SIDED|80.0|0.13|0.55|||ANCOVA|||||0.55|0.13|0.0423
71663596|NCT01994291|142840347|SUPERIORITY_OR_OTHER||Difference in LS means|0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|80.0|0.36|0.75|||ANCOVA|||||0.75|0.36|0.0004
71663597|NCT01994291|142840347|SUPERIORITY_OR_OTHER||Difference in LS means|0.46|STANDARD_ERROR_OF_MEAN|0.13||0.0004|TWO_SIDED|80.0|0.3|0.63|||ANCOVA|||||0.63|0.30|0.0004
71740977|NCT04607837|142993996|SUPERIORITY||Risk Difference (RD)|10.8||||0.1513|TWO_SIDED|95.0|-3.95|25.56|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||25.56|-3.95|0.1513
71663598|NCT02309138|142840366|SUPERIORITY||Risk Ratio (RR)|0.903||||0.668|TWO_SIDED|97.5|0.538|1.516||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.|A relative risk \< 1 represents a benefit in the direction of the IADPSG group, while a value \> 1 represents a benefit towards the CC group.|Co-primary hypotheses #1: women diagnosed using the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those diagnosed using the Carpenter-Coustan criteria.||1.516|0.538|0.668
71663599|NCT02309138|142840366|SUPERIORITY||Risk Ratio (RR)|0.853||||0.853|TWO_SIDED|97.5|0.493|1.475||Each co-primary hypothesis was tested at the 2.5% significance level.|Regression, Logistic|In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.||"Co-primary hypothesis #2: women classified as no gestational diabetes by the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those classified in the Carpenter-Coustan criteria."||1.475|0.493|0.853
71740978|NCT04607837|142993997|SUPERIORITY||Risk Difference (RD)|10.07||||0.1823|TWO_SIDED|95.0|-4.73|24.87|||Mantel Haenszel|||Difference (%) for etrasimod minus placebo was based on estimated common RD using the Mantel- Haenszel weights, where only participants with an assessment at Baseline and the corresponding visit are included. The 2-sided Nominal p-value was used to test the hypothesis of the RD being 0.||24.87|-4.73|0.1823
71776168|NCT02038452|143051551|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.009|TWO_SIDED|95.0|-1.72|-0.24||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||-0.24|-1.72|0.009
71663600|NCT02309138|142840367|SUPERIORITY||Risk Ratio (RR)|1.046||||0.6669|TWO_SIDED|95.0|0.847|1.291|||Regression, Logistic|||||1.291|0.847|0.6669
71663601|NCT02309138|142840367|SUPERIORITY||Risk Ratio (RR)|1.033||||0.8394|TWO_SIDED|95.0|0.816|1.307|||Regression, Logistic|||||1.307|0.816|0.8394
71776169|NCT02038452|143051552|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.058|TWO_SIDED|95.0|-0.02|1.54||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.54|-0.02|0.058
71776170|NCT02038452|143051553|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.95|TWO_SIDED|95.0|-0.79|0.85||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||0.85|-0.79|0.95
71776171|NCT02038452|143051554|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.35|TWO_SIDED|95.0|-0.45|1.26||Participants with relevant outcomes reported on at least one follow-up time point were included in the analyses. Adjustment was made for baseline score, age, duration of symptoms, interaction term between treatment and follow-up.|Mixed Models Analysis|||||1.26|-0.45|0.35
71663602|NCT02309138|142840368|SUPERIORITY||Risk Ratio (RR)|0.987||||0.9335|TWO_SIDED|95.0|0.74|1.318|||Regression, Logistic|||||1.318|0.740|0.9335
71663603|NCT02309138|142840368|SUPERIORITY||Risk Ratio (RR)|1.022||||0.926|TWO_SIDED|95.0|0.742|1.407|||Regression, Logistic|||||1.407|0.742|0.9260
71663604|NCT02309138|142840369|SUPERIORITY||Risk Ratio (RR)|1.4||||0.0322|TWO_SIDED|95.0|1.027|1.909|||Regression, Logistic|||||1.909|1.027|0.0322
71663605|NCT02309138|142840369|SUPERIORITY||Risk Ratio (RR)|1.233||||0.2643|TWO_SIDED|95.0|0.864|1.76|||Regression, Logistic|||||1.760|0.864|0.2643
71663606|NCT01590797|142840413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.5|-0.19|||Robust Regression|Robust regression using M-estimation with terms for treatment and the metformin stratum and type of insulin, and baseline A1C (%) as a covariate.||||-0.19|-0.50|<0.001
71663607|NCT01590797|142840414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Robust Regression|Robust regression using M-estimation with terms for treatment and type of insulin, and baseline A1C (%) as a covariate.||||-0.14|-0.61|0.002
71663608|NCT01590797|142840415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|||<|0.001|TWO_SIDED|95.0|-38.4|-14.7|||ANCOVA|ANCOVA model with terms for treatment and the metformin stratum and type of insulin, and baseline 2-hr Post- Meal Glucose (mg/dL) as a covariate.||||-14.7|-38.4|<0.001
71663609|NCT01798316|142840468|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71663610|NCT01695863|142840505|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.0001|TWO_SIDED|95.0|0.269|0.816|||t-test, 2 sided|||Right Colon||0.816|0.269|<0.0001
71663611|NCT01695863|142840505|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.005|TWO_SIDED|95.0|0.122|0.655|||t-test, 2 sided|||Transverse Colon||0.655|0.122|0.005
71663612|NCT01695863|142840505|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.08|TWO_SIDED|95.0|-0.029|0.484|||t-test, 2 sided|||Left Colon||0.484|-0.029|0.08
71663613|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.093|TWO_SIDED||||||t-test, 2 sided|||Calcium||||0.093
71663614|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|2.03||||0.801|TWO_SIDED||||||t-test, 2 sided|||Glucose||||0.801
71663615|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.599|TWO_SIDED||||||t-test, 2 sided|||Blood Urea Nitrogen||||0.599
71663616|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.696|TWO_SIDED||||||t-test, 2 sided|||Creatinine||||0.696
71663617|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.042|TWO_SIDED||||||t-test, 2 sided|||Sodium||||.042
71663618|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.596|TWO_SIDED||||||t-test, 2 sided|||Potassium||||0.596
71663619|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.107|TWO_SIDED||||||t-test, 2 sided|||Chloride||||0.107
71663620|NCT01695863|142840506|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.351|TWO_SIDED||||||t-test, 2 sided|||Bicarbonate||||0.351
71663621|NCT01695863|142840507|SUPERIORITY||Mean Difference (Final Values)|-0.0438||||0.772|TWO_SIDED||||||t-test, 2 sided|||Nausea||||0.772
71663622|NCT01695863|142840507|SUPERIORITY||Mean Difference (Final Values)|-0.2821||||0.028|TWO_SIDED||||||t-test, 2 sided|||Vomiting||||0.028
71663623|NCT01695863|142840507|SUPERIORITY||Mean Difference (Final Values)|-0.2102||||0.235|TWO_SIDED||||||t-test, 2 sided|||Bloating||||0.235
71663624|NCT01695863|142840507|SUPERIORITY||Mean Difference (Final Values)|-0.0547||||0.707|TWO_SIDED||||||t-test, 2 sided|||Abdominal pain or cramping||||0.707
71663625|NCT01695863|142840507|SUPERIORITY||Mean Difference (Final Values)|-0.0269||||0.773|TWO_SIDED||||||t-test, 2 sided|||Ability to complete entire prep||||0.773
71663626|NCT01695863|142840507|SUPERIORITY||Mean Difference (Final Values)|0.0498||||0.766|TWO_SIDED||||||t-test, 2 sided|||Difficulty/Inconvenience in completing prep||||0.766
71663627|NCT02552212|142840518|OTHER||Odds Ratio (OR)|15.231|||<|0.001|TWO_SIDED|95.0|7.336|31.623|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and Magnetic Resonance Imaging/C- Reactive Protein (MRI/CRP) classification.||31.623|7.336|<0.001
71663628|NCT02552212|142840519|OTHER||Odds Ratio (OR)|7.436|||<|0.001|TWO_SIDED|95.0|4.127|13.401|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||13.401|4.127|<0.001
71663629|NCT02552212|142840529|OTHER||Odds Ratio (OR)|7.359|||<|0.001|TWO_SIDED|95.0|4.286|12.636|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region MRI/CRP classification.||12.636|4.286|<0.001
71663630|NCT02552212|142840530|OTHER||Difference|-1.696|||<|0.001|TWO_SIDED|95.0|-2.11|-1.282|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.282|-2.110|<0.001
71663631|NCT02552212|142840531|OTHER||Difference|-1.585|||<|0.0001|TWO_SIDED|95.0|-2.132|-1.038|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.038|-2.132|<0.0001
71663632|NCT02552212|142840532|OTHER||Difference|-1.819|||<|0.001|TWO_SIDED|95.0|-2.25|-1.388|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.388|-2.250|<0.001
71663633|NCT02552212|142840533|OTHER||Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.909|-0.672|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.672|-1.909|<0.001
71663634|NCT02552212|142840534|OTHER||Difference|-4.8687|||<|0.001|TWO_SIDED|95.0|-6.4014|-3.336|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-3.3360|-6.4014|<0.001
71663635|NCT02552212|142840535|OTHER||Odds Ratio (OR)|6.223|||<|0.001|TWO_SIDED|95.0|3.8|10.191|||Regression, Logistic|||Odds ratio: CZP/Placebo and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||10.191|3.800|<0.001
71663636|NCT02552212|142840536|OTHER||Difference|-0.183|||<|0.001|TWO_SIDED|95.0|-0.25|-0.117|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-0.117|-0.250|<0.001
71663637|NCT02552212|142840544|OTHER||Difference|-1.9|||<|0.001|TWO_SIDED|95.0|-2.62|-1.18|||ANCOVA|||From an ANCOVA model including scores at Baseline, treatment group, region and MRI/CRP classification.||-1.18|-2.62|<0.001
71663638|NCT02552212|142840545|OTHER||Odds Ratio (OR)|0.484|||=|0.247|TWO_SIDED|95.0|0.142|1.653|||Regression, Logistic|||Odds ratio: CZP/PBO and p-value were calculated using logistic regression with factors for treatment, region and MRI/CRP classification.||1.653|0.142|=0.247
71663639|NCT04080544|142840586|OTHER|Null-hypothesis significance testing|Slope|-1.42|STANDARD_ERROR_OF_MEAN|0.81||0.081|TWO_SIDED|95.0|-3.03|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to episodic memory.||0.18|-3.03|.081
71663640|NCT04080544|142840586|OTHER|Null-hypothesis significance test|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.13||0.604|TWO_SIDED|95.0|-0.32|0.19||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of episodic memory.||0.19|-0.32|.604
71663641|NCT04080544|142840587|OTHER|Null-hypothesis significance test|Slope|1.77|STANDARD_ERROR_OF_MEAN|0.81||0.033|TWO_SIDED|95.0|0.15|3.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for baseline age, sex, and years of education.||Regression testing the relationship between amyloid accumulation (annualized change score for amyloid SUVR) to temporal tau SUVR.||3.39|0.15|.033
71663642|NCT04080544|142840588|OTHER|Null-hypothesis significance testing|Slope|0.272|STANDARD_ERROR_OF_MEAN|0.7||0.699|TWO_SIDED|95.0|-1.12|1.66||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to speed of processing.||1.66|-1.12|.699
71663643|NCT04080544|142840588|OTHER|Null-hypothesis significance test|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.154|TWO_SIDED|95.0|-0.06|0.38||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in the prediction of speed of processing.||0.38|-0.06|.154
71663644|NCT04080544|142840589|OTHER|Null-hypothesis significance testing|Slope|-1.11|STANDARD_ERROR_OF_MEAN|0.74||0.137|TWO_SIDED|95.0|-2.58|0.36||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to reasoning function.||0.36|-2.58|.137
71663645|NCT04080544|142840589|OTHER|Null-hypothesis significance test|Slope|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.428|TWO_SIDED|95.0|-0.16|0.37||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of reasoning.||0.37|-0.16|.428
71663646|NCT04080544|142840590|OTHER|Null-hypothesis significance test|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.78||0.376|TWO_SIDED|95.0|-2.25|0.86||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to working memory.||0.86|-2.25|.376
71663647|NCT04080544|142840590|OTHER|Null-hypothesis significance test|Slope|0.27|STANDARD_ERROR_OF_MEAN|0.13||0.039|TWO_SIDED|95.0|0.01|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the interaction of temporal tau SUVR and amyloid SUVR in prediction of working memory.||0.53|0.01|.039
71663648|NCT04080544|142840590|OTHER|Null-hypothesis significance test|Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.27||0.091|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD below the mean for amyloid||||.091
71663649|NCT04080544|142840590|OTHER|Null-hypothesis significance test|Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.296|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at the mean for amyloid SUVR||||.296
71663650|NCT04080544|142840590|OTHER|Null-hypothesis significance test|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.695|TWO_SIDED|||||A priori threshold was two-sided 0.017 after Bonferroni correction for multiple comparisons (3 post hoc tests).|sim_slopes (R interactions package)|||Post hoc simple slopes test of the amyloid x tau interaction (Statistical Analysis #2) at 1SD above the mean for amyloid SUVR||||.695
71663651|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.012|TWO_SIDED|95.0|0.0004|0.004||A prior threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to inferior temporal SUVR.||0.004|0.0004|.012
71663652|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|-0.000005|STANDARD_ERROR_OF_MEAN|0.00004||0.905|TWO_SIDED|95.0|-0.000009|0.00008||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to inferior temporal SUVR.||0.00008|-0.000009|.905
71663653|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.006|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to inferior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.006
71663654|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|0.0003|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to middle temporal gyrus SUVR.||0.003|0.0003|.018
71663655|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00004||0.579|TWO_SIDED|95.0|-0.0001|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustment for multiple comparisons.||Regression testing the relationship of age(quadratic) to middle temporal SUVR.||0.00006|-0.0001|.579
71663656|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.008|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to middle temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.008
71834011|NCT00431834|143172070|SUPERIORITY_OR_OTHER||binomial proportions|5.3|||<|0.0001|ONE_SIDED|97.5||13.1||The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.|Fisher Exact|||"The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p \< 23.6%"||13.1||<0.0001
71663657|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.00006|STANDARD_ERROR_OF_MEAN|0.0004||0.897|TWO_SIDED|95.0|-0.001|0.001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age to superior temporal SUVR.||0.001|-0.001|.897
71663658|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|-0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.539|TWO_SIDED|95.0|-0.00007|0.00003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to superior temporal SUVR.||0.00003|-0.00007|.539
71834012|NCT03628885|143172075|SUPERIORITY||||||<|0.02||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||<.02
71834013|NCT03628885|143172075|SUPERIORITY||||||=|0.07||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||||||=.07
71663659|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|-0.00001|STANDARD_ERROR_OF_MEAN|0.0004||0.973|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to superior temporal SUVR. Growth modeling was performed using SPSS curve estimation.||||.973
71663660|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2|TWO_SIDED|95.0|-0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to entorhinal SUVR.||0.003|-0.001|.200
71663661|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.00005|STANDARD_ERROR_OF_MEAN|0.00005||0.346|TWO_SIDED|95.0|-0.00005|0.0001||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to entorhinal SUVR.||0.0001|-0.00005|.346
71663662|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.283|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing relationship of age(growth model) to entorhinal SUVR. Growth modeling was performed using SPSS curve estimation.||||.283
71663663|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.001||0.011|TWO_SIDED|95.0|0.0004|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to parahippocampal SUVR.||0.003|0.0004|.011
71663664|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.00002|STANDARD_ERROR_OF_MEAN|0.00003||0.536|TWO_SIDED|95.0|-0.00004|0.00009||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to parahippocampal SUVR.||0.00009|-0.00004|.536
71663665|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.001||0.013|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to parahippocampal SUVR. Growth modeling was performed using SPSS curve estimation.||||.013
71740979|NCT02123823|142994176|OTHER||Hazard Ratio, log|0.97||||0.9057|TWO_SIDED|95.0|0.57|1.65|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.65|0.57|0.9057
71663666|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.002|STANDARD_ERROR_OF_MEAN|0.0005|<|0.001|TWO_SIDED|95.0|0.001|0.003||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(linear) to fusiform SUVR.||0.003|0.001|<.001
71663667|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.00001|STANDARD_ERROR_OF_MEAN|0.00003||0.692|TWO_SIDED|95.0|-0.00004|0.00006||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(quadratic) to fusiform SUVR.||0.00006|-0.00004|.692
71740980|NCT02123823|142994179|OTHER||Odds Ratio, log|0.7||||0.5598|TWO_SIDED|95.0|0.2|2.32|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement at screening.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.32|0.20|0.5598
71740981|NCT02123823|142994180|OTHER||Hazard Ratio, log|1.03||||0.9146|TWO_SIDED|95.0|0.59|1.8|||Log Rank|Two-sided log-rank test stratified for visceral involvement.|Cox proportional hazards model stratified for visceral involvement.|||1.80|0.59|0.9146
71663668|NCT04080544|142840591|OTHER|Null-hypothesis significance test|Slope|0.001|STANDARD_ERROR_OF_MEAN|0.0004|<|0.001|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|No adjustments were made.||Regression testing the relationship of age(growth model) to fusiform SUVR. Growth modeling was performed using SPSS curve estimation.||||<.001
71663669|NCT04080544|142840592|OTHER|Null-hypothesis significance testing|Slope|0.18|STANDARD_ERROR_OF_MEAN|0.18||0.331|TWO_SIDED|95.0|-0.18|0.53||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to inferior temporal gyrus cortical thickness.||0.53|-0.18|.331
71663670|NCT04080544|142840592|OTHER|Null-hypothesis significance testing|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.636|TWO_SIDED|95.0|-0.24|0.39||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education||Regression testing the relationship between temporal tau SUVR to middle temporal gyrus cortical thickness.||0.39|-0.24|.636
71776172|NCT02038452|143051555|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.54|<0.001
71776173|NCT02038452|143051556|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.59|-0.21|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.21|-0.59|<0.001
71740982|NCT02123823|142994181|OTHER||Odds Ratio, log|0.7||||0.4008|TWO_SIDED|95.0|0.31|1.59|||Regression, Logistic|Odds ratio and p-value are obtained from logistic regression model adjusted for visceral involvement.|An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||1.59|0.31|0.4008
71740983|NCT03453489|142994186|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
71740984|NCT04346654|142994189|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
71740985|NCT04346654|142994190|SUPERIORITY|||||||0.5133|||||||Regression, Logistic|||||||0.5133
71740986|NCT02915978|142994214|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.0505|TWO_SIDED|95.0|-3.61|0.0|||ANCOVA|||NRS PID at 1 hour||0.00|-3.61|0.0505
71776174|NCT02038452|143051557|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.005|TWO_SIDED|95.0|-0.44|-0.08|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.08|-0.44|0.005
71663671|NCT04080544|142840592|OTHER|Null-hypothesis significance testing|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.16||0.024|TWO_SIDED|95.0|0.05|0.7||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to superior temporal gyrus cortical thickness.||0.70|0.05|.024
71663672|NCT04080544|142840592|OTHER|Null-hypothesis significance testing|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.235|TWO_SIDED|95.0|-0.73|0.18||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to parahippocampal gyrus cortical thickness.||0.18|-0.73|.235
71663673|NCT04080544|142840592|OTHER|Null-hypothesis significance testing|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.639|TWO_SIDED|95.0|-0.63|1.01||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship between temporal tau SUVR to entorhinal gyrus cortical thickness.||1.01|-0.63|.639
71663674|NCT04080544|142840592|OTHER|Null-hypothesis significance test|Slope|0.19|STANDARD_ERROR_OF_MEAN|0.16||0.252|TWO_SIDED|95.0|-0.13|0.5||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to fusiform gyrus cortical thickness.||0.50|-0.13|.252
71663675|NCT04080544|142840593|OTHER|Null-hypothesis significance test|Slope|-233.74|STANDARD_ERROR_OF_MEAN|469.31||0.619|TWO_SIDED|95.0|-1163.28|695.79||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to hippocampal volume.||695.79|-1163.28|.619
71663676|NCT04080544|142840594|OTHER|Null-hypothesis significance test|Slope|9260.01|STANDARD_ERROR_OF_MEAN|3836.92||0.017|TWO_SIDED|95.0|1660.52|16859.51||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to volume of white matter hypointensities.||16859.51|1660.52|.017
71663677|NCT04080544|142840595|OTHER|Null-hypothesis significance test|Slope|0.29|STANDARD_ERROR_OF_MEAN|0.35||0.411|TWO_SIDED|95.0|-0.41|0.99||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to activation of inferior frontal gyrus (beta) on the semantic judgment fMRI task.||0.99|-0.41|.411
71740987|NCT02915978|142994214|OTHER||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.9||0.2493|TWO_SIDED|95.0|-2.89|0.77|||ANCOVA|||NRS PID at 1 hour||0.77|-2.89|0.2493
71740988|NCT02915978|142994214|OTHER||LS Mean Difference|-2.94|STANDARD_ERROR_OF_MEAN|0.99||0.0052|TWO_SIDED|95.0|-4.95|-0.94|||ANCOVA|||NRS PID at 16 hours||-0.94|-4.95|0.0052
71663678|NCT04080544|142840595|OTHER|Null-hypothesis significance test|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.34|0.81||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to middle temporal gyrus activation (beta) on the semantic judgment fMRI task.||0.81|-0.34|.412
71663679|NCT04080544|142840595|OTHER|Null-hypothesis significance test|Slope|0.31|STANDARD_ERROR_OF_MEAN|0.4||0.438|TWO_SIDED|95.0|-0.48|1.09||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to precuneus gyrus activation (beta) on the semantic judgment fMRI task.||1.09|-0.48|.438
71663680|NCT04080544|142840596|OTHER|Null-hypothesis significance test|Slope|-1.13|STANDARD_ERROR_OF_MEAN|0.5||0.026|TWO_SIDED|95.0|-2.12|-0.14||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Regression, Linear|Adjusted for age, sex, and years of education.||Regression testing the relationship of temporal tau SUVR to resting-state system segregation.||-0.14|-2.12|.026
71663681|NCT00197496|142840603|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.3|||<|0.05|TWO_SIDED|95.0|-72.1|19.6|||Regression, Linear|||||19.6|-72.1|<0.05
71740989|NCT02915978|142994214|OTHER||LS Mean Difference|-1.67|STANDARD_ERROR_OF_MEAN|0.97||0.0926|TWO_SIDED|95.0|-3.62|0.29|||ANCOVA|||NRS PID at 16 hours||0.29|-3.62|0.0926
71776175|NCT02038452|143051558|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.002|TWO_SIDED|95.0|-1.72|-0.38|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.38|-1.72|0.002
71663682|NCT00197496|142840606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.4|TWO_SIDED|95.0|-3.6|9.2|||Regression, Linear|||||9.2|-3.6|0.40
71663683|NCT00469911|142840687|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71663684|NCT00213135|142840691|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.35|0.54|||Wald Chi-square test|||||0.54|0.35|<0.001
71663685|NCT00213135|142840691|SUPERIORITY_OR_OTHER||Relative Risk|0.43|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.34|0.54|||Wald Chi-square test|||||0.54|0.34|<0.001
71740990|NCT02915978|142994214|OTHER||LS Means Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.0951|TWO_SIDED|95.0|-3.06|0.26|||ANCOVA|||NRS PID at 24 hours||0.26|-3.06|0.0951
71740991|NCT02915978|142994214|OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.8||0.9866|TWO_SIDED|95.0|-1.6|1.63|||ANCOVA|||NRS PID at 24 hours||1.63|-1.60|0.9866
71776176|NCT02038452|143051559|SUPERIORITY||Odds Ratio (OR)|0.35||||0.006|TWO_SIDED|95.0|0.17|0.74|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.17|0.006
71740992|NCT02343406|142994242|OTHER||Cox Proportional Hazard|0.71|||=|0.062|TWO_SIDED|95.0|0.5|1.02||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.02|0.5|= 0.062
71776177|NCT02038452|143051560|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.58|TWO_SIDED|95.0|-0.13|0.24|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.24|-0.13|0.58
71776178|NCT02038452|143051561|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.25|TWO_SIDED|95.0|-0.09|0.35|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.09|0.25
71663686|NCT01917916|142840703|OTHER||Slope|2.4386|STANDARD_ERROR_OF_MEAN|0.3417|||TWO_SIDED|95.0|1.7504|3.1267|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter Cmax, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1267|1.7504|
71663687|NCT01917916|142840704|OTHER||Slope|2.6033|STANDARD_ERROR_OF_MEAN|0.2499|||TWO_SIDED|95.0|2.0993|3.1073|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-∞, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.1073|2.0993|
71663688|NCT01917916|142840705|OTHER||Slope|3.1291|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|2.3395|3.9187|||||Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is actually standard error of slope.|Dose proportionality was explored using the power model. Dose proportionality of BI 655064 was to be assessed based on the exposure parameter AUC0-tz, determined for the 4 subcutaneous dose levels. This analysis is for the overall population.||3.9187|2.3395|
71663689|NCT02618759|142840706|SUPERIORITY|||||||0.0745|||||||Cochran-Mantel-Haenszel|||||||0.0745
71663690|NCT02618759|142840707|SUPERIORITY|||||||0.231|||||||Cochran-Mantel-Haenszel|||||||0.2310
71663691|NCT02618759|142840708|SUPERIORITY|||||||0.1059|||||||Cochran-Mantel-Haenszel|||||||0.1059
71663692|NCT02618759|142840709|SUPERIORITY|||||||0.6962|||||||Cochran-Mantel-Haenszel|||||||0.6962
71663693|NCT02618759|142840710|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
71776179|NCT02038452|143051562|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.93|TWO_SIDED|95.0|-0.17|0.18|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.18|-0.17|0.93
71663694|NCT02618759|142840711|SUPERIORITY|||||||0.1044|||||||Cochran-Mantel-Haenszel|||||||0.1044
71776180|NCT02038452|143051563|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.052|TWO_SIDED|95.0|-0.01|1.61|||Regression, Linear|Complete case analysis as a sensitivity analysis was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.61|-0.01|0.052
71663695|NCT00605540|142840732|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.||||0.09
71663696|NCT01235195|142840737|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|104.86|||||TWO_SIDED|90.0|100.12|109.83|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||109.83|100.12|
71663697|NCT01235195|142840738|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|105.34|||||TWO_SIDED|90.0|98.46|112.69|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.69|98.46|
71663698|NCT01235195|142840740|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of adjusted means|106.1|||||TWO_SIDED|90.0|100.16|112.39|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.||112.39|100.16|
71776181|NCT02038452|143051564|SUPERIORITY||Odds Ratio (OR)|1.29||||0.53|TWO_SIDED|95.0|0.58|2.88|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.88|0.58|0.53
71663699|NCT01473524|142840743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
71663700|NCT01473524|142840745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.||||<0.0001
71663701|NCT01473524|142840746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
71776182|NCT02038452|143051565|SUPERIORITY||Odds Ratio (OR)|1.43||||0.41|TWO_SIDED|95.0|0.61|3.34|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.34|0.61|0.41
71776183|NCT02038452|143051567|SUPERIORITY||Odds Ratio (OR)|1.32||||0.52|TWO_SIDED|95.0|0.57|3.06|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.06|0.57|0.52
71776184|NCT02038452|143051568|SUPERIORITY||Odds Ratio (OR)|2.05||||0.18|TWO_SIDED|95.0|0.72|5.78|||Regression, Logistic|Complete case analysis as a sensitivity analysis was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||5.78|0.72|0.18
71776185|NCT02038452|143051569|SUPERIORITY||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.18|-0.55|<0.001
71776186|NCT02038452|143051570|SUPERIORITY||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.19|-0.59|<0.001
71776187|NCT02038452|143051571|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.003|TWO_SIDED|95.0|-0.46|-0.09|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.09|-0.46|0.003
71776188|NCT02038452|143051572|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.001|TWO_SIDED|95.0|-1.85|-0.48|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.48|-1.85|0.001
71776189|NCT02038452|143051573|SUPERIORITY||Odds Ratio (OR)|0.34||||0.007|TWO_SIDED|95.0|0.16|0.74|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.74|0.16|0.007
71776190|NCT02038452|143051574|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.63|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.25|-0.15|0.63
71776191|NCT02038452|143051575|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.28|TWO_SIDED|95.0|-0.1|0.35|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.35|-0.10|0.28
71663702|NCT01473524|142840747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.||||<0.0001
71663703|NCT01473524|142840748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71663704|NCT01473524|142840748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71890862|NCT03093402|143303442|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.788|TWO_SIDED|95.0|-4.0|4.94||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Anxiety T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.8 (-4.8, 1.2).|||4.94|-4.00|0.788
71663705|NCT01473524|142840749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0004
71776192|NCT02038452|143051576|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9|TWO_SIDED|95.0|-0.18|0.2|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.20|-0.18|0.900
71776193|NCT02038452|143051577|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.09|TWO_SIDED|95.0|-0.11|1.59|||Regression, Linear|Per protocol analysis on complete date was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||1.59|-0.11|0.09
71776194|NCT02038452|143051578|SUPERIORITY||Odds Ratio (OR)|1.26||||0.58|TWO_SIDED|95.0|0.56|2.85|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for baseline score, sex, age, and duration of symptoms.||||2.85|0.56|0.58
71663706|NCT01473524|142840749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71776195|NCT02038452|143051579|SUPERIORITY||Odds Ratio (OR)|1.31||||0.52|TWO_SIDED|95.0|0.57|3.01|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||3.01|0.57|0.52
71776196|NCT02038452|143051581|SUPERIORITY||Odds Ratio (OR)|1.25||||0.61|TWO_SIDED|95.0|0.53|2.95|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||2.95|0.53|0.61
71663707|NCT01473524|142840750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71663708|NCT01473524|142840750|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71663709|NCT01473524|142840751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71663710|NCT01473524|142840751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71663711|NCT01473524|142840752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||0.0003
71776197|NCT02038452|143051582|SUPERIORITY||Odds Ratio (OR)|2.24||||0.14|TWO_SIDED|95.0|0.77|6.58|||Regression, Logistic|Per protocol analysis on complete date was performed. Logistic regression adjusted for sex, age, and duration of symptoms.||||6.58|0.77|0.14
71776198|NCT02038452|143051583|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.014|TWO_SIDED|95.0|-0.93|-0.12|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.12|-0.93|0.014
71663712|NCT01473524|142840752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor||||||<0.0001
71663713|NCT01473524|142840753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71776199|NCT02038452|143051584|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.53|TWO_SIDED|95.0|-0.5|0.26|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.26|-0.50|0.53
71776200|NCT02038452|143051585|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.015|TWO_SIDED|95.0|-0.44|-0.05|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.05|-0.44|0.015
71776201|NCT02038452|143051586|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-0.97|-0.23|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||-0.23|-0.97|0.002
71776202|NCT02038452|143051587|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.25|TWO_SIDED|95.0|-0.6|0.16|||Regression, Linear|Sub group analysis on complete data was performed. Linear regression adjusted for baseline score, sex, age, and duration of symptoms.||||0.16|-0.60|0.25
71776203|NCT02038452|143051588|SUPERIORITY||Mean Difference (Final Values)|33.54|||||TWO_SIDED|95.0|-94.57|145.59|||Regression, Linear|Comparison of outcome between treatment groups performed on multiply imputed data||||145.59|-94.57|
71834014|NCT03628885|143172075|SUPERIORITY||||||<|0.01||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05|ANOVA|||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P\<.05||||<.01
71834015|NCT02590432|143172101|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.5|||Fisher's Exact Test|||LINZESS® 145 μg versus (vs) LINZESS® 290 μg||5.5|0.3|1.0000
71663714|NCT01473524|142840753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.||||||<0.0001
71776204|NCT02038452|143051589|SUPERIORITY||Mean Difference (Final Values)|47.06|||||TWO_SIDED|95.0|-104.84|187.31|||Regression, Linear|Comparison of outcome between treatment groups on complete data.||||187.31|-104.84|
71776205|NCT02038452|143051590|SUPERIORITY||Mean Difference (Final Values)|113.15|||||TWO_SIDED|95.0|-37.09|279.21|||Regression, Linear|Comparison of outcome between treatment groups||||279.21|-37.09|
71776206|NCT02038452|143051591|SUPERIORITY||Mean Difference (Final Values)|71.1|||||TWO_SIDED|95.0|-120.84|291.24|||Regression, Linear|Comparison of outcome between treatment groups||||291.24|-120.84|
71776207|NCT02038452|143051592|SUPERIORITY||Mean Difference (Final Values)|0.008|||||TWO_SIDED|95.0|-0.01|0.02|||Regression, Linear|||||0.02|-0.01|
71663715|NCT01544179|142840756|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.273|TWO_SIDED|95.0|0.65|1.13|||Cox Proportional Hazards|||||1.13|0.65|0.273
71663716|NCT01544179|142840759|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.62||||0.029|TWO_SIDED|95.0|1.05|2.52|||Cox Proportional Hazards|||||2.52|1.05|0.029
71663717|NCT01544179|142840760|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.76|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||||1.55|0.55|0.760
71663718|NCT01544179|142840761|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.308|TWO_SIDED|95.0|0.74|2.62|||Regression, Logistic|||||2.62|0.74|0.308
71663719|NCT01544179|142840762|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.77|TWO_SIDED|95.0|0.53|1.59|||Regression, Logistic|||||1.59|0.53|0.770
71776208|NCT02038452|143051593|SUPERIORITY||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.034|0.027|||Regression, Linear|||||0.027|-0.034|
71776209|NCT02038452|143051594|SUPERIORITY||Mean Difference (Final Values)|-0.022|||||TWO_SIDED|95.0|-0.093|0.045|||Regression, Linear|||||0.045|-0.093|
71776210|NCT03438383|143051688|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.88||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.88
71776211|NCT03438383|143051688|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.23||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.23
71834016|NCT02590432|143172101|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0844|TWO_SIDED|95.0|0.1|1.1|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.1|0.1|0.0844
71834017|NCT02590432|143172101|SUPERIORITY||Odds Ratio (OR)|0.9||||1|TWO_SIDED|95.0|0.3|2.5|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.5|0.3|1.0000
71834018|NCT02590432|143172102|SUPERIORITY||Odds Ratio (OR)|1.3||||1|TWO_SIDED|95.0|0.3|5.1|||Fisher's Exact Test|||LINZESS® 145 μg vs LINZESS® 290 μg||5.1|0.3|1.0000
71834019|NCT02590432|143172102|SUPERIORITY||Odds Ratio (OR)|0.2||||0.0799|TWO_SIDED|95.0|0.1|1.0|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg||1.0|0.1|0.0799
71834020|NCT02590432|143172102|SUPERIORITY||Odds Ratio (OR)|0.7||||0.7871|TWO_SIDED|95.0|0.3|2.2|||Fisher's Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg||2.2|0.3|0.7871
71834021|NCT02590432|143172104|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.993|TWO_SIDED|95.0|0.42|2.19|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.19|0.42|0.9930
71834022|NCT02590432|143172104|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.0247|TWO_SIDED|95.0|0.11|0.89|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.89|0.11|0.0247
71663720|NCT01544179|142840763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.507|TWO_SIDED|95.0|0.68|1.21|||Cox Proportional Hazards|||||1.21|0.68|0.507
71663721|NCT01544179|142840764|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.725|TWO_SIDED|95.0|0.54|1.53|||Regression, Logistic|||||1.53|0.54|0.725
71663722|NCT01544179|142840765|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.575|TWO_SIDED|95.0|0.69|1.23|||Cox Proportional Hazards|||||1.23|0.69|0.575
71776212|NCT03438383|143051688|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 hours post-operatively||||0.008
71776213|NCT03438383|143051688|SUPERIORITY|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.001||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.001
71776214|NCT03438383|143051689|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.75||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.75
71776215|NCT03438383|143051689|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.09||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.09
71776216|NCT03438383|143051689|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.008
71776217|NCT03438383|143051689|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.013||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.013
71834023|NCT02590432|143172104|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.5149|TWO_SIDED|95.0|0.41|1.5|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.50|0.41|0.5149
71834024|NCT02590432|143172105|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.9519|TWO_SIDED|95.0|0.39|2.18|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg||2.18|0.39|0.9519
71834025|NCT02590432|143172105|SUPERIORITY||Hazard Ratio (HR)|0.27||||0.0234|TWO_SIDED|95.0|0.08|0.87|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg||0.87|0.08|0.0234
71890863|NCT03093402|143303443|SUPERIORITY||Mean Difference (Final Values)|-1.49||||0.766|TWO_SIDED|95.0|-6.14|3.16||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.16|-6.14|0.766
71663723|NCT01544179|142840766|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.959|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||||1.68|0.61|0.959
71663724|NCT01544179|142840767|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.437|TWO_SIDED|95.0|0.66|1.2|||Cox Proportional Hazards|||||1.20|0.66|0.437
71663725|NCT03857750|142840824|OTHER||Mean Difference (Final Values)|82.0|||<|0.001|TWO_SIDED|95.0|40.0|124.0|||t-test, 2 sided|||Comparing onset time of rocuronium||124|40|<0.001
71663726|NCT03857750|142840824|OTHER||Odds|19.48|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Mann-Whitney odd||95 % confidence interval is 7.63 to infinity|82||||<0.001
71834026|NCT02590432|143172105|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.4518|TWO_SIDED|95.0|0.39|1.47|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg||1.47|0.39|0.4518
71834027|NCT04788641|143172106|OTHER||Geometric LS Mean Ratio (%)|71.1|||||TWO_SIDED|90.0|65.44|77.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||77.24|65.44|
71663727|NCT03857750|142840826|OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|14.0|48.0|||t-test, 2 sided|||Comparing duration of action of rocuronium||48|14|<0.001
71663728|NCT03857750|142840826|OTHER||Odds|6.35||||0.001|TWO_SIDED||||||Wilcoxon Mann-Whitney odd||95% Confidence interval is 2.59 to infinity.|Comparing duration of action of rocuronium||||0.001
71663729|NCT03201445|142840834|OTHER||Difference in Percentage|-7.8|||||TWO_SIDED|95.0|-16.3|0.7|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||0.7|-16.3|
71663730|NCT03201445|142840836|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1.8|-2.1|
71663731|NCT03201445|142840838|OTHER||Median Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-13.4|24.7|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||24.7|-13.4|
71663732|NCT03201445|142840840|OTHER||Median Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4.9|-2.8|
71663733|NCT03201445|142840842|OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.3|-0.1|
71663734|NCT03201445|142840844|OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|0.0|4.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||4|0|
71663735|NCT03203564|142840849|OTHER||Mean Difference (Final Values)|7.4|||||TWO_SIDED|90.0|0.68|14.12|||||Parameter estimate is done for Placebo-corrected change-from baseline QTcF (ΔΔQTcF) for Modufolin 500 mg/m2 at end of infusion.|"The primary analysis of QTcF was based on a linear mixed-effects model with change-from-baseline QTcF as the dependent variable, time (categorical), treatment, and time-by-treatment interaction as fixed effects, and baseline QTcF as a covariate. The least-squares (LS) mean and 2-sided 90 % CIs have been calculated for the contrast Modufolin® versus placebo at each dose of Modufolin® and each post-dose time point."||14.12|0.68|
71663736|NCT04630158|142840880|SUPERIORITY||Least Square (LS) mean difference|1.6|STANDARD_ERROR_OF_MEAN|5.1||0.93|TWO_SIDED|95.0|-8.5|11.7||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||11.7|-8.5|0.930
71663737|NCT04630158|142840880|SUPERIORITY||Least Square (LS) mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.11||0.699|TWO_SIDED|95.0|-6.4|13.8||Reporting the adjusted p-value derived based on Dunett procedure.|Mixed Models Analysis|mixed-model repeated measures (MMRM) analysis||||13.8|-6.4|0.699
71663738|NCT05162014|142840897|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|Cox proportional hazards regression models based on time-to-first acute pancreatitis used to estimate the hazard ratios.||||1.02|0.76|
71663739|NCT03496610|142840910|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed given non-normal distribution of data by Shapiro Wilks Test. Null hypothesis is that there is no difference in oral morphine equivalent consumption between the two groups in the first 24hrs after surgery. Original sample size calculation based on α=0.05, β=0.8, difference in means=2, and effect size of 1.0.||||0.81
71663740|NCT03496610|142840911|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference between the two groups in pain on postoperative day 7.||||0.40
71663741|NCT03496610|142840912|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test performed with α=0.05. The null hypothesis is that there is no difference in bloating severity between the two groups.||||0.74
71663742|NCT03496610|142840913|OTHER|||||||0.38|||||||Chi-squared|Degrees of freedom = 1||Compared using the Likelihood ratio test with α=0.05. The null hypothesis was that there is no difference between the groups.||||0.38
71663743|NCT02714426|142840929|OTHER|||||||0.024||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,33) = 5.57, p = .024, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).||||.024
71663744|NCT02714426|142840930|OTHER|||||||0.333||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.96, p = .333, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.333
71663745|NCT02714426|142840932|OTHER|||||||0.001||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-8) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31.069) = 15.046, p = .001, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.001
71663746|NCT02714426|142840933|OTHER|||||||0.448||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.589, p = .0.448, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.448
71740993|NCT02343406|142994242|OTHER||Cox Proportional Hazard|1.04|||=|0.835|TWO_SIDED|95.0|0.73|1.48||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||1.48|0.73|= 0.835
71740994|NCT02343406|142994243|OTHER||Cox Proportional Hazard|0.77|||=|0.123|TWO_SIDED|95.0|0.55|1.07||2-sided|Log Rank|||||1.07|0.55|= 0.123
71663747|NCT02714426|142840934|OTHER|||||||0.439||||||A priori threshold for statistical significance was set at p \< .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31) = 0.616, p = 0.439, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).||||0.439
71663748|NCT01727726|142840935|OTHER||Mean Difference (Final Values)|-1.48||||0.0078|TWO_SIDED|95.0|-2.56|-0.39|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||-0.39|-2.56|0.0078
71776218|NCT03438383|143051690|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.05
71776219|NCT03438383|143051690|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.55||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.55
71776220|NCT03438383|143051690|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.13||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48h post-operatively||||0.13
71776221|NCT03438383|143051690|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.011||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.011
71776222|NCT03438383|143051691|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.83||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)||||0.83
71776223|NCT03438383|143051691|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.37||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||24 h post-operatively||||0.37
71776224|NCT03438383|143051691|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||0.0035||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||48 h post-operatively||||0.0035
71663749|NCT01727726|142840935|OTHER||Mean Difference (Final Values)|-0.3||||0.6642|TWO_SIDED|95.0|-1.63|1.04|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)||||1.04|-1.63|0.6642
71776225|NCT03438383|143051691|SUPERIORITY|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (\> 80%) for each of the examined variables.||||||1.5e-05||||||The a priori threshold for statistical significance was set at \<0.05|ANOVA|||72 h post-operatively||||0.000015
71663750|NCT01727726|142840936|OTHER||Mean Difference (Final Values)|-0.23||||0.1334|TWO_SIDED|95.0|-0.52|0.07|||MMRM|Mixed-model repeated measures (MMRM)||||0.07|-0.52|0.1334
71663751|NCT01727726|142840936|OTHER||Mean Difference (Final Values)|0.42||||0.0237|TWO_SIDED|95.0|0.06|0.78|||MMRM|Mixed-model repeated measures (MMRM)||||0.78|0.06|0.0237
71663752|NCT01727726|142840937|OTHER||Mean Difference (Final Values)|-1.53||||0.0001|TWO_SIDED|95.0|-2.29|-0.76|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 2||-0.76|-2.29|0.0001
71663753|NCT01727726|142840937|OTHER||Mean Difference (Final Values)|-1.22||||0.0103|TWO_SIDED|95.0|-2.15|-0.29|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 2||-0.29|-2.15|0.0103
71776226|NCT02766465|143051697|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the first year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||<0.001
71834028|NCT04788641|143172106|OTHER||Geometric LS Mean Ratio (%)|102.9|||||TWO_SIDED|90.0|96.11|110.1|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||110.1|96.11|
71890864|NCT03093402|143303443|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.766|TWO_SIDED|95.0|-3.6|5.11||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||5.11|-3.60|0.766
71663754|NCT01727726|142840937|OTHER||Mean Difference (Final Values)|-1.17||||0.0185|TWO_SIDED|95.0|-2.15|-0.2|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 4||-0.20|-2.15|0.0185
71663755|NCT01727726|142840937|OTHER||Mean Difference (Final Values)|-0.08||||0.8949|TWO_SIDED|95.0|-1.27|1.11|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 4||1.11|-1.27|0.8949
71740995|NCT02343406|142994243|OTHER||Cox Proportional Hazard|1.31|||=|0.117|TWO_SIDED|95.0|0.93|1.84||2-sided|Log Rank|||||1.84|0.93|= 0.117
71740996|NCT02343406|142994251|OTHER||Odds Ratio (OR)|3.1|||=|0.06|TWO_SIDED|95.0|0.6|16.16||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||16.16|0.6|= 0.06
71740997|NCT02343406|142994251|OTHER||Odds Ratio (OR)|1.21|||=|0.767|TWO_SIDED|95.0|0.12|12.49||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, \> 0), timing of relapse (\< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).||12.49|0.12|= 0.767
71740998|NCT02343406|142994252|OTHER||Cox Proportional Hazard|0.67|||=|0.127|TWO_SIDED|95.0|0.4|1.13||2-sided|Log Rank|||||1.13|0.4|= 0.127
71740999|NCT02343406|142994252|OTHER||Cox Proportional Hazard|0.88|||=|0.64|TWO_SIDED|95.0|0.52|1.49||2-sided|Log Rank|||||1.49|0.52|= 0.64
71776227|NCT02766465|143051697|SUPERIORITY|||||||0.027||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing significant cerebrovascular event between two biologically assigned arms during the first year after biologic assignment. Significant cerebrovascular event includes stroke, transient ischemic attack, and seizure. The null hypothesis is that there is no difference in biologically assigned arms during the first year after assignment.||||0.027
71776228|NCT02766465|143051697|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing severe Vaso-occlusive pain (VOC) with hospitalization or parenteral opioid drugs in outpatient setting between two biologically assigned arms during the second year after biologic assignment. The null hypothesis is that there is no difference in biologically assigned arms during the second year after assignment.||||< 0.001
71776229|NCT02766465|143051698|SUPERIORITY|||||||0.869||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 6MWD from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.869
71776230|NCT02766465|143051699|SUPERIORITY|||||||0.636||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TRJV from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.636
71663756|NCT01727726|142840938|OTHER||Mean Difference (Final Values)|-0.15||||0.035|TWO_SIDED|95.0|-0.29|-0.01|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||-0.01|-0.29|0.0350
71776231|NCT02766465|143051701|SUPERIORITY|||||||0.242||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Physical Function changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.242
71776232|NCT02766465|143051702|SUPERIORITY|||||||0.343||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Anxiety changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.343
71663757|NCT01727726|142840938|OTHER||Mean Difference (Final Values)|-0.05||||0.5601|TWO_SIDED|95.0|-0.22|0.12|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score||0.12|-0.22|0.5601
71663758|NCT01727726|142840938|OTHER||Mean Difference (Final Values)|-0.19||||0.0146|TWO_SIDED|95.0|-0.35|-0.04|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||-0.04|-0.35|0.0146
71663759|NCT01727726|142840938|OTHER||Mean Difference (Final Values)|-0.04||||0.7127|TWO_SIDED|95.0|-0.23|0.15|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score||0.15|-0.23|0.7127
71741000|NCT00766051|142994266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|1.76|<|0.005|TWO_SIDED|95.0|5.0|11.0||The P value is not adjusted for multiple comparisons or for statistical significance|t-test, 2 sided|||The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.||11|5|<0.005
71741001|NCT00766051|142994267|SUPERIORITY_OR_OTHER||Slope|0.275|||<|0.01|||||||Mixed Models Analysis|This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.||Pearson Correlation, 2-tailed||||< 0.01
71776233|NCT02766465|143051703|SUPERIORITY|||||||0.491||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Depression changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.491
71741002|NCT00766051|142994268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_DEVIATION|5.2|<|0.02|ONE_SIDED|95.0||6.7|||t-test, 1 sided||An increase in this test scale score means more parent confidence.|"Parent pre-post one sided t test of parents' global confidence, measured parental confidence in feeding, handling, and interacting with their infant."||6.7||< .02
71663760|NCT01727726|142840939|OTHER||Ratio of response rate|1.49||||0.2242|TWO_SIDED|95.0|0.78|2.84|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.84|0.78|0.2242
71663761|NCT01727726|142840939|OTHER||Ratio of Response Rate|1.26||||0.5998|TWO_SIDED|95.0|0.53|2.98|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.98|0.53|0.5998
71663762|NCT01727726|142840940|OTHER||Ratio of Response Rate|1.52||||0.3321|TWO_SIDED|95.0|0.66|3.49|||Cochran-Mantel-Haenszel|||Phase B Week 6||3.49|0.66|0.3321
71741003|NCT00766051|142994269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8|STANDARD_DEVIATION|4.3|<|0.03|ONE_SIDED|95.0||4.54|||t-test, 1 sided||An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.|Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .||4.54||< .03
71741004|NCT01340586|142994303|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.787|||||TWO_SIDED|90.0|0.616|1.006||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.006|0.616|
71741005|NCT01340586|142994303|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.904|||||TWO_SIDED|90.0|0.697|1.173||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.173|0.697|
71741006|NCT01340586|142994303|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.871|||||TWO_SIDED|90.0|0.723|1.049||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.049|0.723|
71741007|NCT01340586|142994305|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.187|||||TWO_SIDED|90.0|0.907|1.553||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.553|0.907|
71741008|NCT01340586|142994305|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.389|||||TWO_SIDED|90.0|1.097|1.758||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.758|1.097|
71776234|NCT02766465|143051704|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing fatigue score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
71776235|NCT02766465|143051705|SUPERIORITY|||||||0.594||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Sleep Disturbance changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.594
71663763|NCT01727726|142840940|OTHER||Ratio of Response Rate|0.51||||0.3917|TWO_SIDED|95.0|0.11|2.46|||Cochran-Mantel-Haenszel|||Phase B Week 6||2.46|0.11|0.3917
71663764|NCT01727726|142840941|OTHER||Ratio of Response Rate|1.35||||0.0032|TWO_SIDED|95.0|1.1|1.66|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.66|1.10|0.0032
71741009|NCT01340586|142994305|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.855|||||TWO_SIDED|90.0|0.707|1.033||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.033|0.707|
71741010|NCT01340586|142994307|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.165|||||TWO_SIDED|90.0|0.88|1.543||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function||1.543|0.880|
71741011|NCT01340586|142994307|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.357|||||TWO_SIDED|90.0|1.066|1.728||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function||1.728|1.066|
71741012|NCT01340586|142994307|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.858|||||TWO_SIDED|90.0|0.707|1.042||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis||1.042|0.707|
71776236|NCT02766465|143051706|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing social roles score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.003
71663765|NCT01727726|142840941|OTHER||Ratio of Response Rate|1.24||||0.0898|TWO_SIDED|95.0|0.98|1.59|||Cochran-Mantel-Haenszel|||Phase B Week 6||1.59|0.98|0.0898
71663766|NCT01727726|142840943|OTHER||Mean Difference (Final Values)|0.16||||0.448|TWO_SIDED|95.0|-0.25|0.56|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||0.56|-0.25|0.4480
71663767|NCT01727726|142840943|OTHER||Mean Difference (Final Values)|0.52||||0.038|TWO_SIDED|95.0|0.03|1.02|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score||1.02|0.03|0.0380
71663768|NCT01727726|142840943|OTHER||Mean Difference (Final Values)|-0.34||||0.0436|TWO_SIDED|95.0|-0.66|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||-0.01|-0.66|0.0436
71663769|NCT01727726|142840943|OTHER||Mean Difference (Final Values)|0.43||||0.035|TWO_SIDED|95.0|0.03|0.84|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score||0.84|0.03|0.0350
71663770|NCT01727726|142840943|OTHER||Mean Difference (Final Values)|-0.35||||0.0424|TWO_SIDED|95.0|-0.69|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||-0.01|-0.69|0.0424
71741013|NCT03671213|142994329|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Non-inferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \> 0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
71741014|NCT03223337|142994339|OTHER||Ratio of Geometric Least Square(LS) Mean|1.9973|||||TWO_SIDED|90.0|1.1063|3.6057|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6057|1.1063|
71741015|NCT03223337|142994339|OTHER||Ratio of Geometric LS Mean|1.6471|||||TWO_SIDED|90.0|1.1267|2.4079|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4079|1.1267|
71741016|NCT03223337|142994339|OTHER||Ratio of Geometric LS Mean|1.6404|||||TWO_SIDED|90.0|1.0744|2.5048|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5048|1.0744|
71663771|NCT01727726|142840943|OTHER||Mean Difference (Final Values)|0.33||||0.123|TWO_SIDED|95.0|-0.09|0.75|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score||0.75|-0.09|0.1230
71741017|NCT03223337|142994339|OTHER||Ratio of Geometric LS Mean|1.4931|||||TWO_SIDED|90.0|1.0876|2.0498|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0498|1.0876|
71741018|NCT03223337|142994339|OTHER||Ratio of Geometric LS Mean|1.6222|||||TWO_SIDED|90.0|1.1594|2.2696|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2696|1.1594|
71741019|NCT03223337|142994339|OTHER||Ratio of Geometric LS Mean|1.3145|||||TWO_SIDED|90.0|0.9896|1.7462|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7462|0.9896|
71741020|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|1.4574|||||TWO_SIDED|90.0|1.035|2.0523|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0523|1.0350|
71741021|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|1.9375|||||TWO_SIDED|90.0|1.3919|2.6968|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.6968|1.3919|
71741022|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|1.8312|||||TWO_SIDED|90.0|1.3342|2.5133|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5133|1.3342|
71741023|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|2.003|||||TWO_SIDED|90.0|1.4654|2.7378|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7378|1.4654|
71741024|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|1.7113|||||TWO_SIDED|90.0|1.2818|2.2847|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2847|1.2818|
71741025|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|1.974|||||TWO_SIDED|90.0|1.5365|2.536|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5360|1.5365|
71741026|NCT03223337|142994340|OTHER||Ratio of Geometric LS Mean|1.4603|||||TWO_SIDED|90.0|0.9081|2.3484|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3484|0.9081|
71741027|NCT03223337|142994343|OTHER||Ratio of Geometric LS Mean|1.9973|||||TWO_SIDED|90.0|1.1061|3.6066|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.6066|1.1061|
71663772|NCT04762277|142840948|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-31.7|23.4|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||23.4|-31.7|
71663773|NCT04762277|142840949|OTHER||Mean Difference (Net)|-96.6|||||TWO_SIDED|95.0|-154.5|-38.8|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-38.8|-154.5|
71741028|NCT03223337|142994343|OTHER||Ratio of Geometric LS Mean|1.6509|||||TWO_SIDED|90.0|1.1285|2.415|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.4150|1.1285|
71741029|NCT03223337|142994343|OTHER||Ratio of Geometric LS Mean|1.6421|||||TWO_SIDED|90.0|1.0732|2.5125|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.5125|1.0732|
71741030|NCT03223337|142994343|OTHER||Ratio of Geometric LS Mean|1.5169|||||TWO_SIDED|90.0|1.0994|2.093|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.0930|1.0994|
71741031|NCT03223337|142994343|OTHER||Ratio of Geometric LS Mean|1.624|||||TWO_SIDED|90.0|1.1599|2.2736|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.2736|1.1599|
71741032|NCT03223337|142994343|OTHER||Ratio of Geometric LS Mean|1.3143|||||TWO_SIDED|90.0|0.9887|1.747|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7470|0.9887|
71741033|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|1.4566|||||TWO_SIDED|90.0|1.0344|2.0513|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.0513|1.0344|
71741034|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|1.9478|||||TWO_SIDED|90.0|1.3935|2.7224|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7224|1.3935|
71741035|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|1.8392|||||TWO_SIDED|90.0|1.335|2.534|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5340|1.3350|
71741036|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|2.0161|||||TWO_SIDED|90.0|1.4711|2.763|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.7630|1.4711|
71741037|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|1.7303|||||TWO_SIDED|90.0|1.2932|2.3151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3151|1.2932|
71741038|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|1.987|||||TWO_SIDED|90.0|1.5426|2.5594|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5594|1.5426|
71663774|NCT04762277|142840950|OTHER||Risk Difference (RD)|0.138|||||TWO_SIDED|95.0|-0.129|0.339|||||Risk difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.339|-0.129|
71663775|NCT04762277|142840951|OTHER||Mean Difference (Net)|-13.9|||||TWO_SIDED|95.0|-25.6|-2.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.3|-25.6|
71663776|NCT04762277|142840952|OTHER||Mean Difference (Net)|-19.8|||||TWO_SIDED|95.0|-36.9|-2.7|||||Difference of Least Squares Means was calculated as : Spesolimab- Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||-2.7|-36.9|
71663777|NCT04762277|142840953|OTHER||Risk Difference (RD)|0.057|||||TWO_SIDED|95.0|-0.132|0.186|||||Risk difference was calculated as: Spesolimab-Placebo. 95% Confidence Interval (CI) for treatment difference is calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.186|-0.132|
71663778|NCT04762277|142840954|OTHER||Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.067|0.338|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.338|-0.067|
71663779|NCT04762277|142840955|OTHER||Risk Difference (RD)|0.183|||||TWO_SIDED|95.0|-0.079|0.375|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.375|-0.079|
71663780|NCT04762277|142840956|OTHER||Risk Difference (RD)|-0.091|||||TWO_SIDED|95.0|-0.331|0.089|||||Risk Difference was calculated as: Spesolimab - Placebo. 95% Confidence Interval (CI) for treatment difference was calculated by Chan and Zhang method.|The difference in the proportion of patients with a response between Spesolimab and placebo was analysed using a logistic regression model. The model included treatment and stratification factor (tumor necrosis factor inhibitor (TNFi)-naive population versus TNFi-failure population) as two categorical variables.||0.089|-0.331|
71741039|NCT03223337|142994344|OTHER||Ratio of Geometric LS Mean|1.4646|||||TWO_SIDED|90.0|0.9086|2.3609|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3609|0.9086|
71741040|NCT03223337|142994345|OTHER||Ratio of Geometric LS Mean|1.9786|||||TWO_SIDED|90.0|1.0557|3.7084|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||3.7084|1.0557|
71741041|NCT03223337|142994345|OTHER||Ratio of Geometric LS Mean|1.2791|||||TWO_SIDED|90.0|0.9241|1.7705|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7705|0.9241|
71741042|NCT03223337|142994345|OTHER||Ratio of Geometric LS Mean|1.2487|||||TWO_SIDED|90.0|0.8675|1.7974|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7974|0.8675|
71741043|NCT03223337|142994345|OTHER||Ratio of Geometric LS Mean|1.1802|||||TWO_SIDED|90.0|0.9165|1.5197|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5197|0.9165|
71741044|NCT03223337|142994345|OTHER||Ratio of Geometric LS Mean|1.2726|||||TWO_SIDED|90.0|0.952|1.7012|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.7012|0.9520|
71741045|NCT03223337|142994345|OTHER||Ratio of Geometric LS Mean|1.0409|||||TWO_SIDED|90.0|0.7927|1.3668|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3668|0.7927|
71741046|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.0097|||||TWO_SIDED|90.0|0.7122|1.4316|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4316|0.7122|
71741047|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.7852|||||TWO_SIDED|90.0|1.2498|2.5498|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.5498|1.2498|
71741048|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.7337|||||TWO_SIDED|90.0|1.2343|2.4353|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4353|1.2343|
71741049|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.7628|||||TWO_SIDED|90.0|1.2898|2.4092|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.4092|1.2898|
71741050|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.6413|||||TWO_SIDED|90.0|1.2055|2.2347|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.2347|1.2055|
71741051|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.8289|||||TWO_SIDED|90.0|1.3992|2.3904|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3904|1.3992|
71663781|NCT04762277|142840957|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-4.4|4.3|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||4.3|-4.4|
71663782|NCT04762277|142840958|OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-9.5|6.9|||||Difference of Least Squares Means was calculated as: Spesolimab-Placebo.|MMRM accounting for the following sources of variation: fixed, categorical effects of treatment at each visit, the effect of stratum (stratification according to TNFi-naive population vs. TNFi-failure population) and the fixed continuous effects of baseline at each visit. The unstructured covariance structure was used to model the within patient measurements. To estimate denominator degrees of freedom the Kenward-Roger approximation was used.||6.9|-9.5|
71663783|NCT00642278|142840960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.747|-0.148||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.148|-0.747|<0.001
71663784|NCT00642278|142840960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.804|-0.207||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.207|-0.804|<0.001
71663785|NCT00642278|142840960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.841|-0.244||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.244|-0.841|<0.001
71663786|NCT00642278|142840960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-1.006|-0.405||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.405|-1.006|<0.001
71776237|NCT02766465|143051707|SUPERIORITY|||||||0.071||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing pain interference score changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.071
71663787|NCT00642278|142840960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-1.029|-0.432||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.432|-1.029|<0.001
71663788|NCT00642278|142840960|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|-0.862|-0.265||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.265|-0.862|<0.001
71663789|NCT00642278|142840961|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.34|-1.39|0.001
71663790|NCT00642278|142840961|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.98|-0.92|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.92|-1.98|<0.001
71663791|NCT00642278|142840961|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.33|-1.27|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.27|-2.33|<0.001
71663792|NCT00642278|142840961|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.32|-1.26|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.26|-2.32|<0.001
71663793|NCT00642278|142840961|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.25|-1.19|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.19|-2.25|<0.001
71663794|NCT00642278|142840961|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.46|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.46|-1.51|<0.001
71663795|NCT00642278|142840963|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|36.1|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|26.07|46.13|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||46.13|26.07|<0.001
71663796|NCT00642278|142840963|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|49.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|39.17|59.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.34|39.17|<0.001
71663797|NCT00642278|142840963|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|48.2|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|37.98|58.42|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||58.42|37.98|<0.001
71663798|NCT00642278|142840963|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|49.0|STANDARD_ERROR_OF_MEAN|5.11|<|0.001|TWO_SIDED|95.0|38.91|59.01|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||59.01|38.91|<0.001
71663799|NCT00642278|142840963|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|60.3|STANDARD_ERROR_OF_MEAN|5.13|<|0.001|TWO_SIDED|95.0|50.17|70.35|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||70.35|50.17|<0.001
71663800|NCT00642278|142840963|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|5.09||0.513|TWO_SIDED|95.0|-13.33|6.67|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||6.67|-13.33|0.513
71663801|NCT00642278|142840965|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.5||0.009|TWO_SIDED|95.0|-2.2|-0.3|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.3|-2.2|0.009
71663802|NCT00642278|142840965|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.002|TWO_SIDED|95.0|-2.5|-0.6|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-0.6|-2.5|0.002
71663803|NCT00642278|142840965|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.||||-0.7|-2.6|<0.001
71663804|NCT00642278|142840965|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
71663805|NCT00642278|142840965|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||-1.4|-3.3|<0.001
71776238|NCT02766465|143051708|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.146
71663806|NCT00642278|142840965|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.371|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).||||1.4|-0.5|0.371
71663807|NCT03713619|142840971|SUPERIORITY||Odds Ratio, log|1.75||||0.007|TWO_SIDED|95.0|1.12|2.73|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.73|1.12|0.0070
71663808|NCT03713619|142840971|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0418|TWO_SIDED|95.0|0.95|2.32|||Regression, Logistic|||Logistic regression analysis of HiSCR50 response at Week 16 (multiple imputation)||2.32|0.95|0.0418
71890865|NCT03093402|143303443|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.766|TWO_SIDED|95.0|-5.55|3.07||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Depression T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.7(-4.6, 1.3).|||3.07|-5.55|0.766
71663809|NCT03713619|142840972|SUPERIORITY||Least square Mean Difference|-23.05|||<|0.0001|TWO_SIDED|95.0|-33.9|-12.21|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-12.21|-33.90|<0.0001
71663810|NCT03713619|142840972|SUPERIORITY||Least Square Mean difference|-18.46||||0.0004|TWO_SIDED|95.0|-29.32|-7.6|||ANCOVA|||Analysis of covariance of percentage change from baseline in AN count at Week 16 (multiple imputation)||-7.60|-29.32|0.0004
71663811|NCT03713619|142840973|SUPERIORITY||Odds Ratio, log|0.42||||0.001|TWO_SIDED|95.0|0.25|0.73|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||0.73|0.25|0.0010
71663812|NCT03713619|142840973|SUPERIORITY||Odds Ratio (OR)|0.71||||0.0926|TWO_SIDED|95.0|0.43|1.17|||Regression, Logistic|||Logistic regression analysis of Flare over 16 weeks (multiple imputation)||1.17|0.43|0.0926
71663813|NCT03713619|142840974|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0248|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||3.40|1.00|0.0248
71663814|NCT03713619|142840974|SUPERIORITY||Odds Ratio, log|1.77||||0.0044|TWO_SIDED|95.0|1.15|2.0|||Regression, Logistic|||Logistic regression analysis of skin pain/NRS30 response at Week 16 (pooled data, multiple imputation)||2.0|1.15|0.0044
71663815|NCT03095638|142840975|OTHER||Ratio|1.0084|||||TWO_SIDED|90.0|0.8626|1.1789||||||||1.1789|0.8626|
71663816|NCT03095638|142840976|OTHER||Ratio|1.0121|||||TWO_SIDED|90.0|0.8648|1.1845||||||||1.1845|0.8648|
71663817|NCT03095638|142840977|OTHER||Ration|1.0329|||||TWO_SIDED|90.0|0.8623|1.2373||||||||1.2373|0.8623|
71663818|NCT03095638|142840978|OTHER||Ratio|1.6242|||||TWO_SIDED|90.0|1.4986|1.7604||||||||1.7604|1.4986|
71663819|NCT03095638|142840978|OTHER||Ratio|1.5448|||||TWO_SIDED|90.0|1.4253|1.6743||||||||1.6743|1.4253|
71663820|NCT03095638|142840979|OTHER||Ratio|1.6292|||||TWO_SIDED|90.0|1.503|1.7661||||||||1.7661|1.5030|
71663821|NCT03095638|142840979|OTHER||Ratio|1.5519|||||TWO_SIDED|90.0|1.4317|1.6822||||||||1.6822|1.4317|
71663822|NCT03095638|142840980|OTHER||Ratio|1.7933|||||TWO_SIDED|90.0|1.6226|1.9819||||||||1.9819|1.6226|
71663823|NCT03095638|142840980|OTHER||Ratio|1.7974|||||TWO_SIDED|90.0|1.6263|1.9865||||||||1.9865|1.6263|
71663824|NCT06281171|142841031|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||||||<.001
71663825|NCT06281171|142841032|SUPERIORITY|||||||0.996|||||||t-test, 2 sided|||||||.996
71663826|NCT06281171|142841033|SUPERIORITY|||||||0.782|||||||t-test, 2 sided|||||||.782
71663827|NCT06281171|142841034|SUPERIORITY|||||||0.54|||||||Regression, Linear|||||||0.54
71663828|NCT06281171|142841035|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
71663829|NCT06281171|142841036|SUPERIORITY|||||||0.3|||||||Regression, Linear|||||||0.30
71663830|NCT06281171|142841037|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71663831|NCT03020589|142841039|SUPERIORITY||Risk Ratio (RR)|1.27||||0.58|TWO_SIDED|95.0|0.67|2.05|||Fisher Exact|||||2.05|0.67|0.58
71663832|NCT03020589|142841040|SUPERIORITY||Risk Ratio (RR)|1.26||||0.46|TWO_SIDED|95.0|0.72|2.02|||Fisher Exact|||||2.02|0.72|0.46
71776239|NCT02766465|143051709|SUPERIORITY|||||||0.649||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing 28-Day Pain Diary Average Pain Intensity changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.649
71776240|NCT02766465|143051710|SUPERIORITY|||||||0.207||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ASCQ-Me Stiffness changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.207
71741052|NCT03223337|142994346|OTHER||Ratio of Geometric LS Mean|1.3367|||||TWO_SIDED|90.0|0.8288|2.1557|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.1557|0.8288|
71741053|NCT03223337|142994347|OTHER||Ratio of Geometric LS Mean|0.905|||||TWO_SIDED|90.0|0.69|1.1869|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.1869|0.6900|
71741054|NCT03223337|142994347|OTHER||Ratio of Geometric LS Mean|0.7415|||||TWO_SIDED|90.0|0.5617|0.9787|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.9787|0.5617|
71741055|NCT03223337|142994347|OTHER||Ratio of Geometric LS Mean|0.7299|||||TWO_SIDED|90.0|0.4387|1.2145|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2145|0.4387|
71741056|NCT03223337|142994347|OTHER||Ratio of Geometric LS Mean|1.1703|||||TWO_SIDED|90.0|0.9|1.5219|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.5219|0.9000|
71741057|NCT03223337|142994347|OTHER||Ratio of Geometric LS Mean|0.9585|||||TWO_SIDED|90.0|0.6664|1.3786|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.3786|0.6664|
71741058|NCT03223337|142994347|OTHER||Ratio of Geometric LS Mean|1.0004|||||TWO_SIDED|90.0|0.7833|1.2778|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.2778|0.7833|
71741059|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.0574|||||TWO_SIDED|90.0|0.7876|1.4197|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4197|0.7876|
71741060|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.0143|||||TWO_SIDED|90.0|0.7332|1.4032|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4032|0.7332|
71776241|NCT02766465|143051711|SUPERIORITY|||||||0.596||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1 changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.596
71776242|NCT02766465|143051712|SUPERIORITY|||||||0.684||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.684
71741061|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.038|||||TWO_SIDED|90.0|0.7695|1.4002|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.4002|0.7695|
71776243|NCT02766465|143051713|SUPERIORITY|||||||0.863||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FEV1/FVC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.863
71741062|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.3427|||||TWO_SIDED|90.0|0.7635|2.3615|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||2.3615|0.7635|
71741063|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.0296|||||TWO_SIDED|90.0|0.6996|1.5151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5151|0.6996|
71776244|NCT02766465|143051714|SUPERIORITY|||||||0.455||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing VC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.455
71741064|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.2721|||||TWO_SIDED|90.0|0.8409|1.9245|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.9245|0.8409|
71741065|NCT03223337|142994348|OTHER||Ratio of Geometric LS Mean|1.2072|||||TWO_SIDED|90.0|0.9398|1.5508|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.5508|0.9398|
71741066|NCT03223337|142994349|OTHER||Median Difference (Final Values)|0.0||||0.6822|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6822
71741067|NCT03223337|142994349|OTHER||Median Difference (Final Values)|0.0||||0.5767|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5767
71741068|NCT03223337|142994349|OTHER||Median Difference (Final Values)|0.0||||0.588|TWO_SIDED|90.0|-1.0|1.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.50|-1.00|0.5880
71741069|NCT03223337|142994349|OTHER||Median Difference (Final Values)|0.0||||0.7716|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5)(Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.7716
71834029|NCT04788641|143172107|OTHER||Geometric LS Mean Ratio (%)|62.91|||||TWO_SIDED|90.0|55.64|71.13|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||71.13|55.64|
71890866|NCT03093402|143303444|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.982|TWO_SIDED|95.0|-6.04|5.17||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||5.17|-6.04|0.982
71741070|NCT03223337|142994349|OTHER||Median Difference (Final Values)|0.5||||0.4093|TWO_SIDED|90.0|-1.0|2.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||2.00|-1.00|0.4093
71741071|NCT03223337|142994349|OTHER||Median Difference (Final Values)|0.0||||0.9837|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.9837
71741072|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||0.6224|TWO_SIDED|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.50|-1.00|0.6224
71741073|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|-1.0|0.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||0.00|-1.00|0.8042
71741074|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
71741075|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||0.5207|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.5207
71741076|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||0.8423|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|0.8423
71741077|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|-1.00|1.0000
71741078|NCT03223337|142994350|OTHER||Median Difference (Final Values)|0.0||||0.8042|TWO_SIDED|90.0|0.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.|||1.00|0.00|0.8042
71776245|NCT02766465|143051715|SUPERIORITY|||||||0.767||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing TLC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.767
71776246|NCT02766465|143051716|SUPERIORITY|||||||0.241||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing RV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.241
71776247|NCT02766465|143051717|SUPERIORITY|||||||0.268||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing ERV changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.268
71663833|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|-2.26|||||TWO_SIDED|95.0|-8.08|2.33||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.33|-8.08|
71834030|NCT04788641|143172107|OTHER||Geometric LS Mean Ratio (%)|97.23|||||TWO_SIDED|90.0|92.93|101.7|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.7|92.93|
71741079|NCT01362608|142994372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.0001|TWO_SIDED|95.0|-28.2|-11.2|||ANCOVA|||||-11.2|-28.2|<0.0001
71741080|NCT01362608|142994373|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.0043|TWO_SIDED|95.0|0.1|0.71|||Regression, Cox|||||0.71|0.10|0.0043
71741081|NCT01336140|142994388|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Chi-squared|||"We calculated that a minimum of 248 subjects are needed to attain 80% power to detect 70% reduction in the incidence of the primary endpoint (diarrhea), assuming an event rate of 15% in the control group (2-tailed α = 0.05). We targeted enrolling 300 patients to allow some room for error in our assumptions.~null hypothesis: incidence of diarrhea is no different between the aminophylline arm and the placebo arm."||||0.002
71741082|NCT01336140|142994389|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71741083|NCT01336140|142994390|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71741084|NCT01336140|142994391|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Chi-squared|||||||1
71741085|NCT03526146|142994394|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
71741086|NCT03526146|142994395|SUPERIORITY|||||||0.047|||||||paired t-test|||||||0.047
71741087|NCT03526146|142994396|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
71741088|NCT03526146|142994397|SUPERIORITY|||||||0.05|||||||paired t-test|||||||0.05
71741089|NCT03526146|142994398|SUPERIORITY|||||||0.009|||||||paired t-test|||||||0.009
71663834|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|-0.49|||||TWO_SIDED|95.0|-9.93|8.65||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||8.65|-9.93|
71663835|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|-2.27|||||TWO_SIDED|95.0|-8.07|2.26||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.26|-8.07|
71663836|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|0.68||||||95.0|-4.96|6.16||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.16|-4.96|
71663837|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|-2.25||||||95.0|-8.18|2.36||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.36|-8.18|
71663838|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-4.84|6.32||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.32|-4.84|
71741090|NCT02214290|142994399|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
71741091|NCT02214290|142994400|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
71741092|NCT02214290|142994401|OTHER||||||<|0.001|||||||ANOVA|post-hoc comparisons were used to determine within-group and between-group differences.||||||<0.001
71741093|NCT00699608|142994403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.267||95.0|-2.74|0.76|||ANCOVA|ANCOVA used (fixed effects: adjusted period baseline, participant baseline, age, gender, period and treatment group; random effect: participant).||||0.76|-2.74|0.267
71741094|NCT01510158|142994418|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.17|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.17|<0.0001
71663839|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|-0.69||||||95.0|-7.75|5.86||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||5.86|-7.75|
71663840|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|72.87||||||95.0|63.32|81.07||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||81.07|63.32|
71663841|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|84.92||||||95.0|76.73|91.05||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||91.05|76.73|
71663842|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|57.94||||||95.0|48.01|67.42||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||67.42|48.01|
71663843|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|62.81||||||95.0|52.33|72.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||72.20|52.33|
71663844|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|92.27||||||95.0|85.26|96.54||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||96.54|85.26|
71663845|NCT00205803|142841049|SUPERIORITY_OR_OTHER||Difference|5.61||||||95.0|1.23|11.86||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||11.86|1.23|
71663846|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|-1.5||||||95.0|-7.9|3.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.6|-7.9|
71663847|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71663848|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|-1.3||||||95.0|-6.9|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-6.9|
71663849|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71663850|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.7|3.9||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.9|-4.7|
71663851|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71663852|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-2.6|7.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.7|-2.6|
71741095|NCT01510158|142994418|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.22|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.22|<0.0001
71741096|NCT01510158|142994419|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.9796|TWO_SIDED|95.0|0.61|1.61|||Negative Binomial Regression|||||1.61|0.61|0.9796
71741097|NCT01510158|142994419|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.6125|TWO_SIDED|95.0|0.54|1.43|||Negative Binomial Regression|||||1.43|0.54|0.6125
71741098|NCT01510158|142994420|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.29||||0.0183|TWO_SIDED|95.0|-0.51|-0.08|||Cochran-Mantel-Haenszel|||||-0.08|-0.51|0.0183
71741099|NCT01510158|142994420|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.5974|TWO_SIDED|95.0|-0.37|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.37|0.5974
71741100|NCT02588261|142994448|SUPERIORITY||Hazard Ratio (HR)|1.611||||0.992|TWO_SIDED|95.0|1.086|2.391|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.391|1.086|0.992
71741101|NCT02588261|142994450|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||1.000
71741102|NCT02588261|142994451|SUPERIORITY||Hazard Ratio (HR)|1.674||||0.998|TWO_SIDED|95.0|1.165|2.406|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.406|1.165|0.998
71741103|NCT02588261|142994452|SUPERIORITY|||||||0.839|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.||||0.839
71663853|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|97.8||||||95.0|92.3|99.7||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||99.7|92.3|
71663854|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|83.6||||||95.0|73.2|90.8||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||90.8|73.2|
71663855|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|29.5||||||95.0|19.7|40.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||40.9|19.7|
71663856|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|12.0||||||95.0|5.9|20.4||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||20.4|5.9|
71663857|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|94.1||||||95.0|86.8|98.1||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||98.1|86.8|
71663858|NCT00205803|142841050|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.0|-4.6|
71663859|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|0.76||||||95.0|0.59|0.96||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.59|
71663860|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.62|1.48||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.48|0.62|
71741104|NCT02588261|142994453|SUPERIORITY||Hazard Ratio (HR)|1.298||||0.78|TWO_SIDED|95.0|0.661|2.548|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR \< 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.||2.548|0.661|0.780
71663861|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Difference|0.85||||||95.0|0.69|1.05||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.05|0.69|
71663862|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.6|1.11||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.11|0.60|
71663863|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|0.62||||||95.0|0.49|0.79||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.79|0.49|
71663864|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.67|1.09||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.09|0.67|
71663865|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|0.77||||||95.0|0.59|1.0||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.59|
71663866|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|39.78||||||95.0|27.47|57.63||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||57.63|27.47|
71663867|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|15.56||||||95.0|11.63|20.81||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||20.81|11.63|
71663868|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|8.67||||||95.0|6.65|11.29||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||11.29|6.65|
71663869|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|9.6||||||95.0|7.07|13.04||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||13.04|7.07|
71663870|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|26.78||||||95.0|20.97|34.22||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||34.22|20.97|
71663871|NCT00205803|142841051|SUPERIORITY_OR_OTHER||Ratio|1.71||||||95.0|1.36|2.16||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||2.16|1.36|
71663872|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|3.08||||||95.0|-7.22|13.73||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||13.73|-7.22|
71663873|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|7.02||||||95.0|-7.28|21.14||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||21.14|-7.28|
71663874|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
71663875|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated||7.73|-9.38|
71663876|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-5.97|5.68||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||5.68|-5.97|
71663877|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.24||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.24|-8.80|
71663878|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|-1.64||||||95.0|-8.8|4.21||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||4.21|-8.80|
71663879|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-9.38|7.73||||||For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated||7.73|-9.38|
71663880|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|-1.74||||||95.0|-11.0|6.99||||||For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated||6.99|-11.00|
71663881|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|-6.36||||||95.0|-17.03|3.16||||||For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated||3.16|-17.03|
71663882|NCT00205803|142841053|SUPERIORITY_OR_OTHER||Difference|1.33||||||95.0|-6.79|9.68||||||For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated||9.68|-6.79|
71663883|NCT00205803|142841054|SUPERIORITY_OR_OTHER||Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.14||||||||2.14|0.69|
71663884|NCT00205803|142841055|SUPERIORITY_OR_OTHER||Ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48||||||||1.48|0.63|
71663885|NCT00205803|142841056|SUPERIORITY_OR_OTHER||Ratio|0.83|||||TWO_SIDED|95.0|0.57|1.21||||||||1.21|0.57|
71663886|NCT00205803|142841057|SUPERIORITY_OR_OTHER||Ratio|1.01|||||TWO_SIDED|95.0|0.66|1.53||||||Polio Type 1||1.53|0.66|
71663887|NCT00205803|142841057|SUPERIORITY_OR_OTHER||Ratio|0.91|||||TWO_SIDED|95.0|0.56|1.49||||||Polio Type 2||1.49|0.56|
71663888|NCT00205803|142841057|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|95.0|0.69|1.84||||||Polio Type 3||1.84|0.69|
71663889|NCT00205803|142841058|SUPERIORITY_OR_OTHER||Ratio|0.92|||||TWO_SIDED|95.0|0.74|1.15||||||Pertussis - FHA||1.15|0.74|
71663890|NCT00205803|142841058|SUPERIORITY_OR_OTHER||Ratio|1.02|||||TWO_SIDED|95.0|0.83|1.25||||||Pertussis - PT||1.25|0.83|
71663891|NCT00205803|142841058|SUPERIORITY_OR_OTHER||Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44||||||Pertussis - Pertactin||1.44|0.76|
71663892|NCT00658021|142841122|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.363||0.444|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline HbA1c, background diabetes therapy strata, week of visit, baseline HbA1c-by-visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix.||0.45|-1.01|0.444
71663893|NCT00658021|142841124|SUPERIORITY|||||||0.562|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 7% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.562
71663894|NCT00658021|142841124|SUPERIORITY|||||||0.621|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \<= 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.621
71663895|NCT00658021|142841124|SUPERIORITY|||||||0.229|||||||Cochran-Mantel-Haenszel|||"Treatment difference in HbA1c \< 6.5% at Week 28:~Treatment group comparison is based on CMH test stratified by screening HbA1c and background diabetes therapy strata. P-value is from the general association statistics."||||0.229
71663896|NCT00658021|142841125|SUPERIORITY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.327||0.005|TWO_SIDED|95.0|-1.58|-0.28|||Mixed Models Analysis|||"Treatment difference in body weight at Week 4:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||-0.28|-1.58|0.005
71663897|NCT00658021|142841125|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.669||0.314|TWO_SIDED|95.0|-2.0|0.65|||Mixed Models Analysis|||"Treatment difference in body weight at Week 12:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||0.65|-2.00|0.314
71663898|NCT00658021|142841125|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.94||0.692|TWO_SIDED|95.0|-2.24|1.5|||Mixed Models Analysis|||"Treatment difference in body weight at Week 20:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.50|-2.24|0.692
71663899|NCT00658021|142841125|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.065||0.679|TWO_SIDED|95.0|-2.56|1.68|||Mixed Models Analysis|||"Treatment difference in body weight at Week 28:~Adjusted LS mean and treatment group difference in the change from baseline values at visit are obtained from a MMRM including treatment, baseline body weight, screening HbA1c strata, background diabetes therapy strata, week of visit, baseline body weight-by visit interaction and treatment-by-visit interaction as fixed effects using an unstructured covariance matrix."||1.68|-2.56|0.679
71663900|NCT00658021|142841126|SUPERIORITY||LS Mean Difference|-0.281|STANDARD_ERROR_OF_MEAN|0.68||0.679|TWO_SIDED|95.0|-1.614|1.052|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum glucose, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.052|-1.614|0.679
71663901|NCT00658021|142841127|SUPERIORITY||LS Mean Difference|0.189|STANDARD_ERROR_OF_MEAN|0.5151||0.714|TWO_SIDED|95.0|-0.821|1.199|||ANCOVA|||Treatment difference for pre-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.199|-0.821|0.714
71663902|NCT00658021|142841127|SUPERIORITY||LS Mean Difference|0.513|STANDARD_ERROR_OF_MEAN|0.5245||0.329|TWO_SIDED|95.0|-0.516|1.541|||ANCOVA|||Treatment difference for post-meal SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.541|-0.516|0.329
71663903|NCT00658021|142841127|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.4015||0.601|TWO_SIDED|95.0|-0.577|0.997|||ANCOVA|||Treatment difference for post-prandial excursion SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||0.997|-0.577|0.601
71663904|NCT00658021|142841127|SUPERIORITY||LS Mean Difference|0.316|STANDARD_ERROR_OF_MEAN|0.4749||0.505|TWO_SIDED|95.0|-0.615|1.248|||ANCOVA|||Treatment difference for overall SMBG: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline SMBG measure, screening HbA1c strata and background diabetes therapy strata as fixed effects.||1.248|-0.615|0.505
71663905|NCT00658021|142841128|SUPERIORITY||LS Mean Difference|-10.82|STANDARD_ERROR_OF_MEAN|43.187||0.802|TWO_SIDED|95.0|-95.48|73.84|||ANCOVA|||Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline fasting serum insulin, screening HbA1c strata and background diabetes therapy strata as fixed effects.||73.84|-95.48|0.802
71741105|NCT02287467|142994466|SUPERIORITY||Odds Ratio (OR)|1.25||||0.33|TWO_SIDED|95.0|0.79|1.97|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.|Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.||1.97|0.79|.33
71741106|NCT02287467|142994467|SUPERIORITY||Odds Ratio (OR)|0.95||||0.84|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.|Odds ratio for being in a better category, from a proportional odds model||1.48|0.61|.84
71741107|NCT02287467|142994468|SUPERIORITY||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Regression, Cox|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs. placebo. An odds ratio \> 1 favors the hIVIG group.|Odds ratio for being in a better group, from a proportional odds model.||1.33|0.57|.52
71741108|NCT02287467|142994469|SUPERIORITY||Odds Ratio (OR)|1.49||||0.2|TWO_SIDED|95.0|0.81|2.74|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio for hIVIG vs placebo. An odds ratio \> 1.0 favors the hIVIG group.|||2.74|0.81|.20
71741109|NCT02287467|142994470|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.44|TWO_SIDED|95.0|0.85|1.45|||Regression, Cox|Stratified by baseline clinical status, region, and participation in the pilot study.|hazard ratio is hIVIG vs placebo; a hazard ratio \>1 favors the hIVIG group.|Deaths during hospitalization are censored after day 7.||1.45|.85|.44
71741110|NCT02287467|142994471|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.4|TWO_SIDED|95.0|0.48|6.15|||Regression, Cox|stratified by baseline clinical status, region, and participation in pilot study|hazard ratio is for hIVIG vs placebo; a hazard ratio \< 1.0 favors the hIVIG group.|||6.15|.48|.40
71741111|NCT02287467|142994472|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.38|1.98|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo; an odds ratio \> 1.0 favors hIVIG|||1.98|.38|.74
71741112|NCT02287467|142994473|SUPERIORITY||Mean Difference (Net)|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.54|||Regression, Linear|Adjusted for baseline RNA, geographic region, and influenza subtype|Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.|||.54|-.26|.49
71741113|NCT02287467|142994474|SUPERIORITY||Odds Ratio (OR)|0.97||||0.93|TWO_SIDED|95.0|0.5|1.97|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study.|Odds ratio is for hIVIG vs placebo.|||1.97|0.5|.93
71741114|NCT02287467|142994475|SUPERIORITY||Odds Ratio (OR)|0.92||||0.81|TWO_SIDED|95.0|0.5|1.82|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG group vs placebo|||1.82|0.5|.81
71741115|NCT02287467|142994476|SUPERIORITY||Odds Ratio (OR)|1.17||||0.55|TWO_SIDED|95.0|0.7|1.95|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study|Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio \> 1 favors the hIVIG group.|Proportional odds for being in a better category||1.95|0.70|.55
71741116|NCT02287467|142994477|SUPERIORITY||Odds Ratio (OR)|1.12||||0.77|TWO_SIDED|95.0|0.5|2.31|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo|||2.31|.5|.77
71834031|NCT04788641|143172108|OTHER||Geometric LS Mean Ratio (%)|65.57|||||TWO_SIDED|90.0|58.69|73.24|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||73.24|58.69|
71896183|NCT02495077|143314343|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.328|TWO_SIDED|95.0|-6.86|2.31|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.31|-6.86|0.328
71741117|NCT02287467|142994478|SUPERIORITY||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.7|2.34|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is expressed as hIVIG vs placebo|||2.34|0.7|.34
71741118|NCT02287467|142994479|SUPERIORITY||Odds Ratio (OR)|0.9||||0.73|TWO_SIDED|95.0|0.5|1.62||adjusted for baseline clinical status, region, and participation in pilot study|Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio \>1 favors the hIVIG group.|||1.62|.50|.73
71741119|NCT02287467|142994480|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.55|1.59|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio (hIVIG vs placebo) is for being in a better category.|Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.||1.59|0.55|.82
71741120|NCT02287467|142994481|SUPERIORITY||Odds Ratio (OR)|3.19||||0.02|TWO_SIDED|95.0|1.21|8.42|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio \> 1 favors the hIVIG group.|Multiple imputation was used to estimate the outcome for one participant.||8.42|1.21|.02
71834032|NCT04788641|143172108|OTHER||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|92.7|101.6|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||101.6|92.70|
71834033|NCT04788641|143172109|OTHER||Geometric LS Mean Ratio (%)|83.86|||||TWO_SIDED|90.0|73.38|95.84|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||95.84|73.38|
71663906|NCT00658021|142841129|SUPERIORITY||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|18.542||0.836|TWO_SIDED|95.0|-40.19|32.51|||ANCOVA|||Treatment difference for HOMA-B: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-B, screening HbA1c strata and background diabetes therapy strata as fixed effects.||32.51|-40.19|0.836
71741121|NCT02287467|142994482|SUPERIORITY||ratio of geometric means|1.5||||0.18|TWO_SIDED|95.0|0.84|2.7|||Mixed Models Analysis|longitudinal regression with adjustment for baseline titer|Ratio of hIVIG group to placebo group. A ratio \> 1.0 indicates higher titers for the hIVIG group.|HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.||2.7|0.84|.18
71741122|NCT02287467|142994483|SUPERIORITY||ratio of geometric means|1.31||||0.13|TWO_SIDED|95.0|0.93|1.8|||Mixed Models Analysis|longitudinal analysis of log-transformed titers adjust for baseline titer.|Ratio of geometric means of hIVIG vs placebo. A ratio \>1.0 indicates higher titers in the hIVIG group on day 7.|||1.8|0.93|.13
71741123|NCT02287467|142994484|SUPERIORITY||ratio of geometric means|0.94||||0.78|TWO_SIDED|95.0|0.58|1.5|||Mixed Models Analysis|log-transformed titers adjusted for baseline titer|ratio of geometric mean for hIVIG vs placebo. A ratio \> 1.0 indicates higher titers at day 7 for the hIVIG group.|||1.5|0.58|.78
71741124|NCT00900666|142994485|NON_INFERIORITY_OR_EQUIVALENCE|a priori power calculation suggested N=26 for each group.||||||0.761|TWO_SIDED|95.0||||p\<0.05 threshold|ANOVA|Correlations with walking speed and time since injury were initially performed to determine whether ANCOVA would be be more appropriate.||ANOVA||||0.761
71776248|NCT02766465|143051718|SUPERIORITY||||||>|0.999||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing IC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||>0.999
71776249|NCT02766465|143051719|SUPERIORITY|||||||0.832||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing FRC changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.832
71776250|NCT02766465|143051720|SUPERIORITY|||||||0.37||||||Statistical significance was determined using a pre-specified threshold of 0.05|Wilcoxon (Mann-Whitney)|||This is the result comparing DLCO changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.370
71776251|NCT02766465|143051721|SUPERIORITY|||||||0.094||||||Statistical significance was determined using a pre-specified threshold of 0.05;|Wilcoxon (Mann-Whitney)|||This is the result comparing oxygen saturation changes from 2 years after biologic assignment to baseline between two biologically assigned arms. The null hypothesis is that there is no difference between biologically assigned arms||||0.094
71776252|NCT02766465|143051723|SUPERIORITY|||||||0.313||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD in patients who received different donor type at transplant||||0.313
71776253|NCT02766465|143051724|SUPERIORITY|||||||0.233||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD in patients who received different donor type at transplant||||0.233
71776254|NCT02435069|143051727|SUPERIORITY|||||||0.069751||||||significance level set at \<0.05 a priori|two-sample pooled variance t-test|Two-tailed||"Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.~Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%)."||||0.069751
71776255|NCT02435069|143051728|SUPERIORITY|||||||0.172|||||||two-sample pooled variance t-test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.172
71776256|NCT02435069|143051731|SUPERIORITY|||||||0.8028|||||||two-sample pooled variance t-test|two-sided||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush in the dosing phase of the study.||||0.8028
71741125|NCT00900666|142994486|SUPERIORITY_OR_OTHER|||||||0.896||95.0|||||ANOVA|||||||.896
71741126|NCT00684775|142994506|SUPERIORITY||Odds Ratio (OR)|6.0|||=|0.002|TWO_SIDED|95.0|1.44|25.0|||General Estimating Equation (GEE)|||||25.0|1.44|=0.002
71741127|NCT00684775|142994507|SUPERIORITY|||||||0.0081|||||||t-test, 2 sided|||||||0.0081
71741128|NCT00684775|142994508|SUPERIORITY||Odds Ratio (OR)|1.34||||0.56|TWO_SIDED|95.0|0.5|3.6|||General Estimating Equation (GEE)|||||3.6|.5|0.56
71741129|NCT00684775|142994509|SUPERIORITY||Odds Ratio (OR)|1.45|||=|0.41|TWO_SIDED|95.0|0.6|3.53|||General Estimating Equation (GEE)|||||3.53|.6|=0.41
71741130|NCT00684775|142994510|SUPERIORITY||Odds Ratio (OR)|1.19||||0.75|TWO_SIDED|95.0|0.42|3.36|||General Estimating Equation (GEE)|||||3.36|.42|0.75
71776257|NCT02435069|143051732|SUPERIORITY|||||||0.346594|||||||two-sample pooled variance t test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.||||0.346594
71776258|NCT02520661|143051737|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.62|1.22||||||treatment relevant change in number of ED visits by 14 days||1.22|0.62|
71776259|NCT02520661|143051737|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.3||||||treatment relevant change in number of ED visits by 30 days||1.30|0.72|
71834034|NCT04788641|143172109|OTHER||Geometric LS Mean Ratio (%)|97.55|||||TWO_SIDED|90.0|87.16|109.2|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||109.2|87.16|
71834035|NCT04788641|143172110|OTHER||Geometric LS Mean Ratio (%)|98.42|||||TWO_SIDED|90.0|94.62|102.4|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Tacrolimus||102.4|94.62|
71741131|NCT00684775|142994511|SUPERIORITY|||||||0.1543|||||||t-test, 2 sided|||||||0.1543
71834036|NCT04788641|143172110|OTHER||Geometric LS Mean Ratio (%)|94.12|||||TWO_SIDED|90.0|85.74|103.3|||||Result based on a mixed effect following a natural logarithmic transformation of the individual PK parameters, with period, treatment, and sequence as fixed effects, and participant nested within sequence as random effects.|Cyclosporin||103.3|85.74|
71834037|NCT03283371|143172112|SUPERIORITY||LS Mean logarithmic difference|-0.16||||0.5053|TWO_SIDED|95.0|-0.62|0.31|||Mixed Model for Repeated Measures (MMRM)|||Analysis is based on MMRM and adjusted for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures), structural etiology category (yes and no), visit, treatment and treatment by visit interaction. An unstructured variance-covariance matrix is used in the model.||0.31|-0.62|0.5053
71834038|NCT03283371|143172113|SUPERIORITY||Odds Ratio (OR)|2.09||||0.2231|TWO_SIDED|95.0|0.64|6.85|||Regression, Logistic|||Based on logistic regression with a term for treatment group and with adjustment for natural log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no).||6.85|0.64|0.2231
71834039|NCT03283371|143172116|SUPERIORITY||Odds Ratio (OR)|0.67||||0.6854|TWO_SIDED|95.0|0.1|4.57|||Regression, Logistic|||Based on the logistic regression model with a term for treatment group and with adjustment for log-transformed baseline seizure frequency, high seizure frequency category (\>=24 seizures and \<24 seizures) and structural etiology category (yes and no) are considered as covariates.||4.57|0.10|0.6854
71834040|NCT02740231|143172141|SUPERIORITY||Adjusted mean difference|-9.49|STANDARD_DEVIATION|6.38||0.141|TWO_SIDED|95.0|-22.21|3.23||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference - adjusted mean change|The primary endpoint is the WOMAC® VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.||3.23|-22.21|0.141
71741132|NCT00684775|142994512|SUPERIORITY||Odds Ratio (OR)|1.82||||0.15|TWO_SIDED|95.0|0.81|4.1|||General Estimating Equation (GEE)|||||4.1|.81|0.15
71741133|NCT00666406|142994513|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.173|||||TWO_SIDED|90.0|1.089|1.262||||||||1.262|1.089|
71741134|NCT00666406|142994514|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.139|||||TWO_SIDED|90.0|1.043|1.243||||||||1.243|1.043|
71741135|NCT00666406|142994515|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.06|||||TWO_SIDED|90.0|0.866|1.297||||||||1.297|0.866|
71741136|NCT00666406|142994516|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.071|||||TWO_SIDED|90.0|0.972|1.179||||||||1.179|0.972|
71741137|NCT00666406|142994517|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.171|||||TWO_SIDED|90.0|1.099|1.247||||||||1.247|1.099|
71741138|NCT00666406|142994518|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.135|||||TWO_SIDED|90.0|1.092|1.18||||||||1.180|1.092|
71834041|NCT02740231|143172142|SUPERIORITY||Adjusted mean difference|-11.63|STANDARD_DEVIATION|5.5||0.038|TWO_SIDED|95.0|-22.6|-0.66||The threshold for statistical significance was p=0.05|ANCOVA||Difference between groups JTA-004 100 (2mL) minus Reference|||-0.66|-22.60|0.038
71834042|NCT02740231|143172143|SUPERIORITY||Adjusted mean difference|-1.48|STANDARD_DEVIATION|4.35||0.997|TWO_SIDED|95.0|-12.7|9.74||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||9.74|-12.70|0.997
71834043|NCT02740231|143172144|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_DEVIATION|5.3||0.972|TWO_SIDED|95.0|-16.52|10.65||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||10.65|-16.52|0.972
71834044|NCT02740231|143172145|SUPERIORITY||Adjusted mean difference|-7.17|STANDARD_DEVIATION|5.96||0.599|TWO_SIDED|95.0|-22.28|7.94||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||||7.94|-22.28|0.599
71834045|NCT02740231|143172146|SUPERIORITY||Adjusted mean difference|-6.62|STANDARD_DEVIATION|4.3||0.126|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.126
71834046|NCT02740231|143172147|SUPERIORITY||Adjusted mean difference|-8.88|STANDARD_DEVIATION|4.76||0.064|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.064
71834047|NCT02740231|143172148|SUPERIORITY||Adjusted mean difference|-10.79|STANDARD_DEVIATION|4.35||0.014|TWO_SIDED|95.0|||||ANCOVA|||||||0.014
71834048|NCT02740231|143172149|SUPERIORITY||Adjusted mean difference|-10.57|STANDARD_DEVIATION|4.81||0.03|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|ANCOVA|||||||0.030
71834049|NCT00999167|143172197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0354|TWO_SIDED|95.0|||||Poisson regression adjusting for country|||||||0.0354
71834050|NCT00999167|143172198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0214||95.0|||||Cochran-Mantel-Haenszel|||||||0.0214
71834051|NCT00999167|143172199|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.047||95.0|||||Regression, Cox|||||||0.047
71834052|NCT00999167|143172200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0713|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and Day 56.||||0.0713
71834053|NCT00999167|143172200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.252|TWO_SIDED|95.0|||||ANCOVA|||Changes in the Total Index Score from Baseline and the Final Visit.||||0.2520
71834054|NCT02554786|143172201|SUPERIORITY||Least Square mean (LS Mean)|0.132|STANDARD_ERROR_OF_MEAN|0.0223|<|0.001|TWO_SIDED|95.0|0.088|0.176|||Mixed Model for Repeated Measures (MMRM)|||||0.176|0.088|<0.001
71834055|NCT02554786|143172201|SUPERIORITY||LS Mean|0.211|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.167|0.255|||MMRM|||||0.255|0.167|<0.001
71834056|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.172|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|-0.254|-0.091|||MMRM|||Week 4||-0.091|-0.254|<0.001
71834057|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.196|STANDARD_ERROR_OF_MEAN|0.0416|<|0.001|TWO_SIDED|95.0|-0.278|-0.115|||MMRM|||Week 4||-0.115|-0.278|<0.001
71663907|NCT00658021|142841129|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|3.846||0.941|TWO_SIDED|95.0|-7.82|7.26|||ANCOVA|||Treatment difference for HOMA-S: Adjusted LS Mean and treatment group difference in the change from baseline values at Week 28 are obtained from multiple imputation ANCOVA including treatment, baseline %HOMA-S, screening HbA1c strata and background diabetes therapy strata as fixed effects.||7.26|-7.82|0.941
71663908|NCT02092467|142841131|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.04|2.09|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||2.09|1.04|
71663909|NCT02092467|142841131|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.43|||||Secondary comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \< 2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.43|0.70|
71663910|NCT02092467|142841131|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|1.0|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||2.18|1.00|
71663911|NCT02092467|142841131|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.48|||||TWO_SIDED|95.0|1.0|2.19|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.19|1.00|
71663912|NCT02092467|142841132|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate Cox proportional hazard model with treatment \[All Tofacitinib (ie, tofacitinib 5 mg BID and tofacitinib 10 mg BID combined) and TNFi\] as covariate.|Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.91|1.94|||||Primary comparison. Non-inferiority was to be claimed between All Tofacitinib and TNFi if the upper limit of the 95% CI for HR was \< 1.8 (non-inferiority criterion).|All Tofacitinib versus TNFi||1.94|0.91|
71663913|NCT02092467|142841132|NON_INFERIORITY|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.77|1.71|||||Secondary Comparison. Non-inferiority was to be claimed between tofacitinib 10 mg BID and tofacitinib 5 mg BID if the upper limit of the 95% CI for HR was \<2.0 (non-inferiority criterion).|Tofacitinib 10 mg BID versus Tofacitinib 5 mg BID||1.71|0.77|
71663914|NCT02092467|142841132|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.81|1.91|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 5 mg BID versus TNFi||1.91|0.81|
71741139|NCT00666406|142994519|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.036|||||TWO_SIDED|90.0|0.857|1.253||||||||1.253|0.857|
71663915|NCT02092467|142841132|OTHER|Hazard ratio (95% CI) was based on a univariate cox proportional hazard model with treatment (tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi) as covariate.|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.94|2.18|||||Supportive analysis to the primary comparison between All Tofacitinib vs TNFi.|Tofacitinib 10 mg BID versus TNFi||2.18|0.94|
71663916|NCT02952898|142841156|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
71663917|NCT02952898|142841156|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.||||<0.0001
71663918|NCT01908907|142841168|SUPERIORITY_OR_OTHER||Median Difference (Net)|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.07|TWO_SIDED|95.0|0.2|28.7|||Regression, Linear|Outcome was transformed using a natural logarithm transformation. Models included gestational age group since the randomization was blocked.|Since analyzed on the log scale, estimates provide are % change rather than absolute change between group.|All analyses used the intent-to-treat study population. A linear mixed model was used to assess differences in time to full feeds, days on study drug, and gestational age at discharge. These models included a random effect for multiples, which was maintained in the model after testing. Fixed effects included treatment and GA group for time to full feeds and days on study drug and treatment effect for gestational age at discharge.||28.7|0.2|0.07
71663919|NCT01908907|142841169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.008||0.048|TWO_SIDED||||||Regression, Linear|This is a complex regression model including linear and quadratic growth and interactions as specified above.||Linear mixed models were used to explore growth over time (weight, length and head circumference). These models included a random effect for intercepts and slopes to account for subject specific growth over time as well as a random effect for possible correlation between twins and triplets present in the data set. Fixed effects included both a linear and quadratic time effect, GA at birth, treatment group, full feeds (yes/no), and interactions. Non-significant interactions were eliminated.||||0.048
71663920|NCT00761657|142841177|OTHER|||||||0.2073||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.2073
71741140|NCT00666406|142994520|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.093|||||TWO_SIDED|90.0|1.007|1.186||||||||1.186|1.007|
71741141|NCT00666406|142994521|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.854|||||TWO_SIDED|90.0|0.798|0.913||||||||0.913|0.798|
71741142|NCT00666406|142994522|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.881|||||TWO_SIDED|90.0|0.847|0.916||||||||0.916|0.847|
71741143|NCT00666406|142994523|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.799|1.164||||||||1.164|0.799|
71741144|NCT00666406|142994524|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.915|||||TWO_SIDED|90.0|0.841|0.995||||||||0.995|0.841|
71741145|NCT00666406|142994525|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.177|||||TWO_SIDED|90.0|1.104|1.256||||||||1.256|1.104|
71776260|NCT04399837|143051753|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.041||||0.002|||||||MCP-Mod linear model fit|Model assumption: Dose effect is linear with the increase of dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
71776261|NCT04399837|143051753|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.033||||0.002|||||||MCP-Mod Emax2 model fit|Model assumption: 95% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
71663921|NCT00761657|142841177|OTHER|||||||0.0046||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0046
71663922|NCT00761657|142841177|OTHER|||||||0.086||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0860
71741146|NCT00666406|142994526|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.039|1.277||||||||1.277|1.039|
71741147|NCT00666406|142994527|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.182|||||TWO_SIDED|90.0|1.029|1.359||||||||1.359|1.029|
71741148|NCT00666406|142994528|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.01|1.27||||||||1.270|1.010|
71741149|NCT00666406|142994529|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.008|||||TWO_SIDED|90.0|0.969|1.05||||||||1.050|0.969|
71741150|NCT00666406|142994530|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.964|||||TWO_SIDED|90.0|0.843|1.102||||||||1.102|0.843|
71741151|NCT00666406|142994531|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.038|||||TWO_SIDED|90.0|0.926|1.163||||||||1.163|0.926|
71741152|NCT00666406|142994532|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.015|||||TWO_SIDED|90.0|0.901|1.144||||||||1.144|0.901|
71741153|NCT00666406|142994533|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.178|||||TWO_SIDED|90.0|1.106|1.254||||||||1.254|1.106|
71741154|NCT00666406|142994534|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.152|||||TWO_SIDED|90.0|1.038|1.279||||||||1.279|1.038|
71776262|NCT04399837|143051753|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|3.088||||0.002|||||||MCP-Mod Emax1 model fit|Model assumption: 70% of the maximum effect is achieved at low dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.002
71834058|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.055|STANDARD_ERROR_OF_MEAN|0.0414||0.186|TWO_SIDED|95.0|-0.136|0.026|||MMRM|||Week 4||0.026|-0.136|0.186
71834059|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.184|STANDARD_ERROR_OF_MEAN|0.0294|<|0.001|TWO_SIDED|95.0|-0.242|-0.127|||MMRM|||Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.127|-0.242|<0.001
71663923|NCT00761657|142841177|OTHER|||||||0.4005||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4005
71663924|NCT00761657|142841177|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is presented for Day 26-29 timepoint. P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71741155|NCT00666406|142994535|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.183|||||TWO_SIDED|90.0|1.027|1.362||||||||1.362|1.027|
71741156|NCT00666406|142994536|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.133|||||TWO_SIDED|90.0|1.012|1.27||||||||1.270|1.012|
71741157|NCT00666406|142994537|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.009|||||TWO_SIDED|90.0|0.964|1.056||||||||1.056|0.964|
71741158|NCT00666406|142994538|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.971|||||TWO_SIDED|90.0|0.849|1.112||||||||1.112|0.849|
71741159|NCT00666406|142994539|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.02|||||TWO_SIDED|90.0|0.938|1.109||||||||1.109|0.938|
71741160|NCT00666406|142994540|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.996|||||TWO_SIDED|90.0|0.894|1.111||||||||1.111|0.894|
71741161|NCT00666406|142994541|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.0|||||TWO_SIDED|90.0|1.0|1.0||||||||1.000|1.000|
71741162|NCT00666406|142994542|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.303|||||TWO_SIDED|90.0|0.841|2.02||||||||2.020|0.841|
71741163|NCT00666406|142994543|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.724|||||TWO_SIDED|90.0|0.304|1.728||||||||1.728|0.304|
71741164|NCT00666406|142994544|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|1.059|||||TWO_SIDED|90.0|0.442|2.539||||||||2.539|0.442|
71741165|NCT00666406|142994545|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.862|||||TWO_SIDED|90.0|0.807|0.92||||||||0.920|0.807|
71741166|NCT00666406|142994546|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.855|||||TWO_SIDED|90.0|0.73|1.002||||||||1.002|0.730|
71741167|NCT00666406|142994547|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.984|||||TWO_SIDED|90.0|0.788|1.228||||||||1.228|0.788|
71741168|NCT00666406|142994548|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the geometric means|0.911|||||TWO_SIDED|90.0|0.8|1.039||||||||1.039|0.800|
71741169|NCT06964165|142994549|OTHER||Difference in pre-IDS ORR|-39.0|||||TWO_SIDED|80.0|-56.8|-17.7|||||||Confidence interval was calculated using the unstratified Miettinen-Nurminen method.|-17.7|-56.8|
71663925|NCT00761657|142841177|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71663926|NCT00761657|142841177|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71663927|NCT00761657|142841177|OTHER||||||<|0.0001|||||||t-test, 2 sided|Threshold for significance at 0.05 level.||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71663928|NCT00761657|142841178|OTHER|||||||0.0507||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0507
71663929|NCT00761657|142841178|OTHER|||||||0.4502||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.4502
71741170|NCT01514201|142994578|OTHER|This was descriptive in nature. Two of the first 5 patients who were escalated to 175 mg/m2 of temozolomide during the maintenance intra-patient dose escalation had dose-modifying toxicities (DMTs). Since the ad hoc stopping rule was met, intra-patient dose escalation was halted and all subsequent patients were to receive 135 mg/m2 of temozolomide during maintenance.|Percentage of patients with DMTs|40.0|||||TWO_SIDED|||||||||Intra-patient dose escalation of temozolomide during maintenance was assessed based on similar rules employed in traditional 3+3 designs. For example intra-patient dose escalation would be halted if at any time 2 out of first 2-6 patients experienced dose-modifying toxicities at a given dose level or if 4 out of first 12 patients experienced dose-modifying toxicities at a given dose level.||||
71663930|NCT00761657|142841178|OTHER|Threshold for significance at 0.05 level.||||||0.1603|||||||t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.1603
71663931|NCT00761657|142841178|OTHER|||||||0.9816||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.9816
71663932|NCT00761657|142841178|OTHER|||||||0.0139||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0139
71663933|NCT00761657|142841178|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71741171|NCT02534909|142994623|OTHER|Bayesian analysis of response rate in serum LDH (period 1 completers only)|Median response rate|99.0|||||TWO_SIDED|95.0|81.9|100.0|||||95% Credibility Interval for Response Rate|Up to Week 4||100.0|81.9|
71776263|NCT04399837|143051753|OTHER|The generalized MCP-Mod procedure for time to event endpoints is based on the log hazard ratio of the active doses vs. placebo obtained via a Cox regression model on the time to first GPP flare.|Multiple contrast test|2.977||||0.003|||||||MCP-Mod exponential model fit|Model assumption: 35% of the maximum effect is achieved at medium dose.||A flat vs. non-flat dose-response relationship across the 3 doses of spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 4 different plausible dose-response patterns (linear, Emax 1, Emax 2 and exponential) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.003
71834060|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0431||0.003|TWO_SIDED|95.0|-0.214|-0.044|||MMRM|||Week 12||-0.044|-0.214|0.003
71663934|NCT00761657|142841178|OTHER|||||||0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||0.0001
71741172|NCT02534909|142994624|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 1 Day 29 serum LDH levels||0.23|0.15|<0.001
71741173|NCT02534909|142994624|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.23|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 2 Day 365 serum LDH levels||0.23|0.15|<0.001
71834061|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0435|<|0.001|TWO_SIDED|95.0|-0.333|-0.162|||MMRM|||Week 12||-0.162|-0.333|<0.001
71834062|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.052|STANDARD_ERROR_OF_MEAN|0.0431||0.232|TWO_SIDED|95.0|-0.136|0.033|||MMRM|||Week 12||0.033|-0.136|0.232
71741174|NCT02534909|142994624|OTHER||Geometric LS mean Ratio to Baseline|0.17|||<|0.001|TWO_SIDED|95.0|0.14|0.2|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 3 Day 1429 serum LDH levels||0.20|0.14|<0.001
71741175|NCT02534909|142994624|OTHER||Geometric LS mean Ratio to Baseline|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed Models Analysis||The longitudinal mixed effects model included timepoint, log baseline as a covariate and the log baseline by timepoint interaction. C5 variant status was included as a categorical covariate.|Period 4 Day 141 serum LDH levels||0.24|0.15|<0.001
71834063|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.188|STANDARD_ERROR_OF_MEAN|0.0307|<|0.001|TWO_SIDED|95.0|-0.248|-0.128|||MMRM|||Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.128|-0.248|<0.001
71834064|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.171|STANDARD_ERROR_OF_MEAN|0.0437|<|0.001|TWO_SIDED|95.0|-0.257|-0.086|||MMRM|||Week 26||-0.086|-0.257|<0.001
71834065|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.248|STANDARD_ERROR_OF_MEAN|0.0439|<|0.001|TWO_SIDED|95.0|-0.334|-0.162|||MMRM|||Week 26||-0.162|-0.334|<0.001
71741176|NCT00566852|142994634|SUPERIORITY_OR_OTHER|||||||0.059||||||Significance level was 0.025.|Wilcoxon (Mann-Whitney)|||Null hypothesis: patients on memantine will experience less decline than patients receiving placebo. Based on a one-sided Wilcoxon rank sum test with alpha=0.025, 221 patients per arm would be required to have 80% statistical power to detect a mean difference of 0.87 in the HVLT-R change scores between the two treatment arms. Assuming that 20% of patients may be ineligible, or die prior to the 24 week assessment, the target sample size for randomization was set to 536.||||0.059
71741177|NCT00566852|142994635|SUPERIORITY|||||||0.0692||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||8 weeks||||0.0692
71741178|NCT00566852|142994635|SUPERIORITY|||||||0.4541||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||16 weeks||||0.4541
71741179|NCT00566852|142994635|SUPERIORITY|||||||0.397||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||52 weeks||||0.3970
71741180|NCT00566852|142994636|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.01|TWO_SIDED|95.0|0.62|0.99|||Gray's test|||A one-sided log-rank test with alpha 0.025 accruing 221 patients/arm with 12 months of follow-up would ensure 98% statistical power to detect a 33% relative reduction in the monthly hazard rate with the use of memantine. Gray's test was used to test for a statistically significant difference in the distribution of neurocognitive failure times and Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||0.99|0.62|0.01
71741181|NCT00566852|142994637|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Assuming normally distributions, the two sample t-test assuming equal variances would be used to compare the arms at the 0.025 significance level. If normality assumptions were not met, the Wilcoxon rank sum would be used.||||0.77
71741182|NCT00566852|142994638|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.27|TWO_SIDED|95.0|0.87|1.3|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.3|0.87|0.27
71741183|NCT00566852|142994639|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.025|TWO_SIDED|95.0|0.86|1.31|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.||1.31|0.86|0.025
71741184|NCT05870865|142994646|SUPERIORITY||Mean Difference (Final Values)|4.28||||0.5483|TWO_SIDED||||||Mixed Models Analysis|||||||0.5483
71741185|NCT05870865|142994646|SUPERIORITY||Mean Difference (Final Values)|-5.89||||0.4123|TWO_SIDED||||||Mixed Models Analysis|||||||0.4123
71741186|NCT05870865|142994646|SUPERIORITY||Mean Difference (Final Values)|1.66||||0.8177|TWO_SIDED||||||Mixed Models Analysis|||||||0.8177
71741187|NCT05870865|142994647|SUPERIORITY||Odds Ratio (OR)|0.66||||0.4601|TWO_SIDED||||||Fisher Exact|||||||0.4601
71741188|NCT05870865|142994647|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0804|TWO_SIDED||||||Fisher Exact|||||||0.0804
71741189|NCT05870865|142994647|SUPERIORITY||Odds Ratio (OR)|1.06|||>|0.9999|TWO_SIDED||||||Fisher Exact|||||||>0.9999
71741190|NCT05870865|142994648|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.2146|TWO_SIDED||||||Mixed Models Analysis|||||||0.2146
71741191|NCT05870865|142994648|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8851|TWO_SIDED||||||Mixed Models Analysis|||||||0.8851
71741192|NCT05870865|142994648|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.1835|TWO_SIDED||||||Mixed Models Analysis|||||||0.1835
71741193|NCT05870865|142994649|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.7982|TWO_SIDED||||||Mixed Models Analysis|||||||0.7982
71741194|NCT05870865|142994649|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.564|TWO_SIDED||||||Mixed Models Analysis|||||||0.5640
71741195|NCT05870865|142994649|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2939|TWO_SIDED||||||Mixed Models Analysis|||||||0.2939
71741196|NCT05870865|142994650|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.3579|TWO_SIDED||||||Mixed Models Analysis|||||||0.3579
71741197|NCT05870865|142994650|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.3466|TWO_SIDED||||||Mixed Models Analysis|||||||0.3466
71741198|NCT05870865|142994650|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9527|TWO_SIDED||||||Mixed Models Analysis|||||||0.9527
71741199|NCT00195663|142994665|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment, the second primary analysis of the modified Total Sharp Score was to be performed.|Chi-squared, Corrected|||The study was powered to demonstrate the superiority of adalimumab + MTX combination therapy vs. MTX monotherapy in the proportion of subjects who achieved an ACR50 response at 52 weeks. Power calculations were based on 250 subjects in each group using a chi-squared test with a continuity correction and an alpha = 0.05 significance level. With 250 subjects in each group, a difference of 0.13 in response rates could be detected with 80% power.||||<0.001
71741200|NCT00195663|142994666|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment on the ACR50 response, the second primary analysis of modified TSS would be performed.||||<0.001
71741201|NCT00195663|142994667|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71741202|NCT00195663|142994668|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71741203|NCT00195663|142994669|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71741204|NCT00195663|142994670|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71741205|NCT00195663|142994671|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71741206|NCT00195663|142994672|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71741207|NCT00195663|142994673|SUPERIORITY_OR_OTHER|||||||0.5402||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5402
71776264|NCT04399837|143051753|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 12 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.468||||0.0269|TWO_SIDED|95.0|0.206|1.064||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: one-sided p-value ≤ 0.01875."|Log Rank||Hazard ratio and its 95% Confidence Interval are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||1.064|0.206|0.0269
71776265|NCT04399837|143051753|SUPERIORITY|Null hypothesis: Effect of spesolimab 300 mg every 4 weeks on prolonging the time to the first GPP flare up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.157||||0.0005|TWO_SIDED|95.0|0.046|0.541||"One-sided p-value is computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~Threshold for statistical significance: One-sided p-value ≤0.0125."|Log Rank||Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.|||0.541|0.046|0.0005
71741208|NCT02058563|142994720|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.91|
71776266|NCT04399837|143051754|SUPERIORITY|Null hypothesis: The proportion of patients who do not experience a GPP flare up to week 48 on BI 655130 300 mg every 4 weeks ≤ Placebo.|Risk Difference (RD)|-0.39||||0.0013|TWO_SIDED|95.0|-0.621|-0.159||"One-sided p-value was computed from the Cochran-Mantel-Haenszel test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Cochran-Mantel-Haenszel||Risk difference=Spesolimab high dose-Placebo.|||-0.159|-0.621|0.0013
71776267|NCT04399837|143051755|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to first worsening of PSS up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.424||||0.0134|TWO_SIDED|95.0|0.197|0.914||"One-sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"|Log Rank||spesolimab high dose vs. Placebo|Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.||0.914|0.197|0.0134
71741209|NCT02058563|142994721|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.||1.16|0.96|
71741210|NCT02058563|142994722|NON_INFERIORITY_OR_EQUIVALENCE|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV\_MMR over COM\_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.|Non-inferiority of INV\_MMR vaccine to COM\_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed||1.11|0.93|
71741211|NCT04522141|142994748|OTHER|||||||0.038||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.038
71776268|NCT04399837|143051756|SUPERIORITY|Null hypothesis: Effect of BI 655130 300 mg every 4 weeks on prolonging the time to the first worsening of DLQI up to week 48 ≤ Placebo.|Hazard Ratio (HR)|0.259||||0.001|TWO_SIDED|95.0|0.109|0.62||One sided p-value was computed from the log-rank test stratified by use of systemic GPP medication at randomisation.|Log Rank||spesolimab high dose vs. Placebo|"Hazard ratio and its 95% CI (confidence interval) are from Cox regression model stratified by use of systemic GPP medication at randomisation.~one-sided alpha= 0.00625"||0.620|0.109|0.0010
71776269|NCT02203071|143051838|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
71776270|NCT02203071|143051839|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
71776271|NCT02203071|143051840|SUPERIORITY||||||>|0.11|||||||t-test, 2 sided|||||||>0.11
71776272|NCT02203071|143051841|SUPERIORITY||||||<|0.007|||||||ANOVA|||||||<0.007
71776273|NCT02203071|143051842|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71776274|NCT02203071|143051843|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71776275|NCT03894046|143051844|NON_INFERIORITY|"Non-inferiority was concluded if the upper limit of the 2-sided 95% CI was less than +20%.~Superiority was concluded if the upper limit of the 2-sided 95% CI was less than 0."|Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-30.0|3.5||||||The non-inferiority assessment was based on the 2-sided 95% CIs computed using a continuity-corrected Z-statistic for the difference (\[sulbactam-durlobactam + imipenem/cilastatin\] - \[colistin + imipenem/cilastatin\]) in 28-day all-cause mortality rates between the treatment groups.||3.5|-30|
71776276|NCT03894046|143051845|OTHER|||||||0.0002||||||p-value was obtained based on a Chi-Square test for treatment group differences.|Chi-squared|||Analysis of patients with nephrotoxicity as measured by RIFLE criteria at any post-baseline visit based on the Investigator's opinion for the Safety Population for Part A, excluding patients with chronic hemodialysis at baseline baseline.||||0.0002
71834066|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0437||0.214|TWO_SIDED|95.0|-0.14|0.031|||MMRM|||Week 26||0.031|-0.140|0.214
71741212|NCT04522141|142994748|SUPERIORITY|||||||0.941||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.941
71663935|NCT00761657|142841178|OTHER||||||<|0.0001||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||P-value is from inter-group 2-sample t-tests comparing roxadustat change from baseline with placebo change from baseline.||||<0.0001
71741213|NCT04522141|142994749|OTHER|||||||0.003||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.003
71741214|NCT04522141|142994749|SUPERIORITY|||||||0.027||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.027
71741215|NCT04522141|142994750|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||< .001
71741216|NCT04522141|142994750|SUPERIORITY|||||||0.411||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.411
71741217|NCT04522141|142994751|OTHER||||||<|0.001||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Main effect weekly self-control||||< .001
71741218|NCT04522141|142994751|SUPERIORITY|||||||0.176||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status|Mixed Models Analysis|||Time by condition interaction weekly self-control||||0.176
71741219|NCT04522141|142994752|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
71741220|NCT04522141|142994752|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
71741221|NCT04522141|142994753|OTHER|||||||0.031||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.031
71741222|NCT04522141|142994753|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.||Time by condition interaction||||0.260
71741223|NCT04522141|142994754|OTHER|||||||0.016||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.016
71741224|NCT04522141|142994754|SUPERIORITY|||||||0.363||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.363
71741225|NCT04522141|142994755|OTHER||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||> .05
71741226|NCT04522141|142994755|SUPERIORITY||||||>|0.05||||||Analyses are controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||> .05
71741227|NCT04522141|142994756|OTHER|||||||0.389||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.389
71741228|NCT04522141|142994756|SUPERIORITY|||||||0.516||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.516
71741229|NCT04522141|142994757|OTHER|||||||0.005||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.005
71741230|NCT04522141|142994757|SUPERIORITY|||||||0.555||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.555
71741231|NCT04522141|142994758|OTHER|||||||0.206||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Main effect||||0.206
71741232|NCT04522141|142994758|SUPERIORITY|||||||0.026||||||Controlled for age, sex, education, race, self-reported functional health, and self-reported health status.|Mixed Models Analysis|||Time by condition interaction||||0.026
71741233|NCT01868477|142994759|OTHER|difference|Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-24.0|48.16||||||||48.16|-24.0|
71741234|NCT01938040|142994787|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
71741235|NCT00806988|142994817|OTHER|An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.||||0.61
71663936|NCT00270855|142841205|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)||||>0.05
71741236|NCT00806988|142994818|OTHER|||||||0.83|||||||Chi-squared|||||||0.83
71741237|NCT01717872|142994819|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||MAC blade lifting the tongue versus Miller blade lifting the epiglottis||||>0.05
71741238|NCT01717872|142994820|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71741239|NCT01717872|142994821|SUPERIORITY_OR_OTHER||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<0.0004
71741240|NCT03078556|142994822|OTHER||Ratio|1.271|||||TWO_SIDED|90.0|1.1894|1.3582|||||Ratio (B/A) of plasma DTG has been presented.|||1.3582|1.1894|
71741241|NCT03078556|142994822|OTHER||Ratio|1.0341|||||TWO_SIDED|90.0|1.0097|1.0591|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0591|1.0097|
71741242|NCT03078556|142994823|OTHER||Ratio|1.155|||||TWO_SIDED|90.0|1.0699|1.2468|||||Ratio (C/A) of plasma DTG has been presented.|||1.2468|1.0699|
71741243|NCT03078556|142994823|OTHER||Ratio|1.0635|||||TWO_SIDED|90.0|1.0413|1.0861|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0861|1.0413|
71741244|NCT03078556|142994824|OTHER||Ratio|1.2756|||||TWO_SIDED|90.0|1.1919|1.3651|||||Ratio (B/A) of plasma DTG has been presented.|||1.3651|1.1919|
71663937|NCT00270855|142841205|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)||||>0.05
71663938|NCT00270855|142841206|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71663939|NCT00270855|142841206|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663940|NCT00270855|142841207|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.519|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.||||0.519
71776277|NCT01973569|143051849|SUPERIORITY|||||||0.0235||||||The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.|van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0235
71663941|NCT00270855|142841207|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71741245|NCT03078556|142994824|OTHER||Ratio|1.0372|||||TWO_SIDED|90.0|1.0116|1.0634|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0634|1.0116|
71741246|NCT03078556|142994825|OTHER||Ratio|1.1578|||||TWO_SIDED|90.0|1.0718|1.2507|||||Ratio (C/A) of plasma DTG has been presented.|||1.2507|1.0718|
71741247|NCT03078556|142994825|OTHER||Ratio|1.0702|||||TWO_SIDED|90.0|1.0464|1.0946|||||Ratio (C/A) of plasma 3TC has been presented.|||1.0946|1.0464|
71741248|NCT03078556|142994826|OTHER||Ratio|1.2805|||||TWO_SIDED|90.0|1.189|1.379|||||Ratio (B/A) of plasma DTG has been presented.|||1.3790|1.1890|
71741249|NCT03078556|142994826|OTHER||Ratio|1.1956|||||TWO_SIDED|90.0|1.1437|1.2498|||||Ratio (B/A) of plasma 3TC has been presented.|||1.2498|1.1437|
71741250|NCT03078556|142994827|OTHER||Ratio|1.141|||||TWO_SIDED|90.0|1.0533|1.2361|||||Ratio (C/A) of plasma DTG has been presented.|||1.2361|1.0533|
71741251|NCT03078556|142994827|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.2616|1.376|||||Ratio (C/A) of plasma 3TC has been presented.|||1.3760|1.2616|
71776278|NCT01973569|143051850|SUPERIORITY|||||||0.036|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0360
71834067|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.209|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.27|-0.149|||MMRM|||Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.149|-0.270|<0.001
71741252|NCT03078556|142994828|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|0.000|
71741253|NCT03078556|142994828|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
71741254|NCT03078556|142994829|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.004|0.0|||||Median Difference of plasma DTG has been presented.|||0.000|-0.004|
71741255|NCT03078556|142994829|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.|||0.000|0.000|
71741256|NCT03078556|142994830|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.5|0.248|||||Median Difference of plasma DTG has been presented.|||0.248|-0.500|
71741257|NCT03078556|142994830|OTHER||Median Difference (Final Values)|-0.126|||||TWO_SIDED|90.0|-0.253|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.253|
71741258|NCT03078556|142994831|OTHER||Median Difference (Final Values)|-0.127|||||TWO_SIDED|90.0|-0.497|0.132|||||Median Difference of plasma DTG has been presented.|||0.132|-0.497|
71741259|NCT03078556|142994831|OTHER||Median Difference (Final Values)|-0.248|||||TWO_SIDED|90.0|-0.376|-0.001|||||Median Difference of plasma 3TC has been presented.|||-0.001|-0.376|
71776279|NCT01973569|143051851|SUPERIORITY|||||||0.1323|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.1323
71776280|NCT01973569|143051852|SUPERIORITY|||||||0.0448|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0448
71776281|NCT01973569|143051853|SUPERIORITY|||||||0.0104|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.0104
71776282|NCT01973569|143051854|SUPERIORITY|||||||0.257|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.||||||0.2570
71834068|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.141|STANDARD_ERROR_OF_MEAN|0.0449||0.002|TWO_SIDED|95.0|-0.229|-0.053|||MMRM|||Week 52||-0.053|-0.229|0.002
71741260|NCT03078556|142994840|OTHER||Ratio|1.2774|||||TWO_SIDED|90.0|1.1931|1.3676|||||Ratio (B/A) of plasma DTG has been presented.|||1.3676|1.1931|
71741261|NCT03078556|142994840|OTHER||Ratio|1.0475|||||TWO_SIDED|90.0|1.0185|1.0773|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0773|1.0185|
71741262|NCT03078556|142994841|OTHER||Ratio|1.1599|||||TWO_SIDED|90.0|1.0711|1.256|||||Ratio (C/A) of plasma DTG has been presented.|||1.2560|1.0711|
71741263|NCT03078556|142994841|OTHER||Ratio|1.0807|||||TWO_SIDED|90.0|1.0539|1.1081|||||Ratio (C/A) of plasma 3TC has been presented.|||1.1081|1.0539|
71741264|NCT03078556|142994842|OTHER||Ratio|0.7868|||||TWO_SIDED|90.0|0.7363|0.8408|||||Ratio (B/A) of plasma DTG has been presented.|||0.8408|0.7363|
71741265|NCT03078556|142994842|OTHER||Ratio|0.967|||||TWO_SIDED|90.0|0.9442|0.9904|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9904|0.9442|
71834069|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.266|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.354|-0.177|||MMRM|||Week 52||-0.177|-0.354|<0.001
71834070|NCT02554786|143172202|SUPERIORITY||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0447||0.824|TWO_SIDED|95.0|-0.078|0.098|||MMRM|||Week 52||0.098|-0.078|0.824
71663942|NCT00270855|142841208|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.||||||0.615|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||0.615
71776283|NCT01973569|143051855|SUPERIORITY||Mean Difference (Net)|5.02|||<|0.0001|TWO_SIDED|95.0|4.41|5.63|||Regression, Cox|ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.||||5.63|4.41|<0.0001
71776284|NCT03711266|143051867|OTHER||Mean Difference (Final Values)|31.4|||<|0.001|TWO_SIDED|95.0|18.5|44.3|||t-test, 2 sided|||Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).||44.3|18.5|<.001
71663943|NCT00270855|142841208|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71741266|NCT03078556|142994843|OTHER||Ratio|0.8658|||||TWO_SIDED|90.0|0.8021|0.9347|||||Ratio (C/A) of plasma DTG has been presented.|||0.9347|0.8021|
71741267|NCT03078556|142994843|OTHER||Ratio|0.9403|||||TWO_SIDED|90.0|0.9207|0.9604|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9604|0.9207|
71741268|NCT03078556|142994844|OTHER||Ratio|0.7859|||||TWO_SIDED|90.0|0.7318|0.844|||||Ratio (B/A) of plasma DTG has been presented.|||0.8440|0.7318|
71741269|NCT03078556|142994844|OTHER||Ratio|0.9704|||||TWO_SIDED|90.0|0.9157|1.0284|||||Ratio (B/A) of plasma 3TC has been presented.|||1.0284|0.9157|
71741270|NCT03078556|142994845|OTHER||Ratio|0.8571|||||TWO_SIDED|90.0|0.7914|0.9282|||||Ratio (C/A) of plasma DTG has been presented.|||0.9282|0.7914|
71741271|NCT03078556|142994845|OTHER||Ratio|0.9153|||||TWO_SIDED|90.0|0.8613|0.9728|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9728|0.8613|
71741272|NCT03078556|142994846|OTHER||Ratio|1.2632|||||TWO_SIDED|90.0|1.1811|1.3511|||||Ratio (B/A) of plasma DTG has been presented.|||1.3511|1.1811|
71741273|NCT03078556|142994846|OTHER||Ratio|0.9598|||||TWO_SIDED|90.0|0.9268|0.9941|||||Ratio (B/A) of plasma 3TC has been presented.|||0.9941|0.9268|
71741274|NCT03078556|142994847|OTHER||Ratio|1.1425|||||TWO_SIDED|90.0|1.0597|1.2317|||||Ratio (C/A) of plasma DTG has been presented.|||1.2317|1.0597|
71741275|NCT03078556|142994847|OTHER||Ratio|0.9548|||||TWO_SIDED|90.0|0.9299|0.9804|||||Ratio (C/A) of plasma 3TC has been presented.|||0.9804|0.9299|
71741276|NCT03078556|142994848|OTHER||Ratio|1.1839|||||TWO_SIDED|90.0|1.0921|1.2834|||||Ratio (B/A) of plasma DTG has been presented|||1.2834|1.0921|
71741277|NCT03078556|142994848|OTHER||Ratio|0.8874|||||TWO_SIDED|90.0|0.834|0.9443|||||Ratio (B/A) of plasma 3TC has been presented|||0.9443|0.8340|
71741278|NCT03078556|142994849|OTHER||Ratio|1.078|||||TWO_SIDED|90.0|0.9958|1.167|||||Ratio (B/A) of plasma DTG has been presented|||1.1670|0.9958|
71741279|NCT03078556|142994849|OTHER||Ratio|0.9049|||||TWO_SIDED|90.0|0.8474|0.9663|||||Ratio (B/A) of plasma 3TC has been presented|||0.9663|0.8474|
71741280|NCT03078556|142994850|OTHER||Ratio|1.1545|||||TWO_SIDED|90.0|1.0208|1.3058|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.3058|1.0208|
71741281|NCT03078556|142994850|OTHER||Ratio|0.9577|||||TWO_SIDED|90.0|0.9126|1.0049|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0049|0.9126|
71741282|NCT03078556|142994851|OTHER||Ratio|1.3256|||||TWO_SIDED|90.0|1.1837|1.4845|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4845|1.1837|
71741283|NCT03078556|142994851|OTHER||Ratio|0.9114|||||TWO_SIDED|90.0|0.8658|0.9593|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9593|0.8658|
71741284|NCT03078556|142994852|OTHER||Ratio|1.1481|||||TWO_SIDED|90.0|1.0154|1.2982|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2982|1.0154|
71741285|NCT03078556|142994852|OTHER||Ratio|0.9524|||||TWO_SIDED|90.0|0.9086|0.9983|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9983|0.9086|
71741286|NCT03078556|142994853|OTHER||Ratio|1.3176|||||TWO_SIDED|90.0|1.175|1.4775|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.4775|1.1750|
71741287|NCT03078556|142994853|OTHER||Ratio|0.9048|||||TWO_SIDED|90.0|0.8592|0.9528|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.9528|0.8592|
71741288|NCT03078556|142994854|OTHER||Ratio|1.0808|||||TWO_SIDED|90.0|0.9527|1.2261|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2261|0.9527|
71741289|NCT03078556|142994854|OTHER||Ratio|0.7097|||||TWO_SIDED|90.0|0.6474|0.7779|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.7779|0.6474|
71741290|NCT03078556|142994855|OTHER||Ratio|1.2096|||||TWO_SIDED|90.0|1.0521|1.3908|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.3908|1.0521|
71741291|NCT03078556|142994855|OTHER||Ratio|0.6826|||||TWO_SIDED|90.0|0.5861|0.795|||||Ratio (Cfed/C) of plasma 3TC has been presented|||0.7950|0.5861|
71741292|NCT03078556|142994856|OTHER||Median Difference (Final Values)|0.254|||||TWO_SIDED|90.0|0.25|0.378|||||Median Difference of plasma DTG has been presented|||0.378|0.250|
71741293|NCT03078556|142994856|OTHER||Median Difference (Final Values)|0.125|||||TWO_SIDED|90.0|0.0|0.127|||||Median Difference of plasma 3TC has been presented|||0.127|0.000|
71741294|NCT03078556|142994857|OTHER||Median Difference (Final Values)|0.126|||||TWO_SIDED|90.0|0.0|0.25|||||Median Difference of plasma DTG has been presented|||0.250|0.000|
71741295|NCT03078556|142994857|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.125|||||Median Difference of plasma 3TC has been presented|||0.125|0.000|
71741296|NCT03078556|142994858|OTHER||Median Difference (Final Values)|3.017|||||TWO_SIDED|90.0|1.872|4.496|||||Median Difference of plasma DTG has been presented|||4.496|1.872|
71741297|NCT03078556|142994858|OTHER||Median Difference (Final Values)|2.113|||||TWO_SIDED|90.0|1.5|2.751|||||Median Difference of plasma 3TC has been presented|||2.751|1.500|
71741298|NCT03078556|142994859|OTHER||Median Difference (Final Values)|2.5|||||TWO_SIDED|90.0|1.748|3.751|||||Median Difference of plasma DTG has been presented|||3.751|1.748|
71741299|NCT03078556|142994859|OTHER||Median Difference (Final Values)|1.503|||||TWO_SIDED|90.0|0.998|2.252|||||Median Difference of plasma 3TC has been presented|||2.252|0.998|
71741300|NCT03078556|142994868|OTHER||Ratio|1.0849|||||TWO_SIDED|90.0|0.9613|1.2245|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.2245|0.9613|
71741301|NCT03078556|142994868|OTHER||Ratio|0.9363|||||TWO_SIDED|90.0|0.8913|0.9836|||||Ratio (Bfed/B) of plasma 3TC has been presented|||0.9836|0.8913|
71741302|NCT03078556|142994869|OTHER||Median Difference (Final Values)|1.2477|||||TWO_SIDED|90.0|1.1013|1.4136|||||Median Difference of plasma DTG has been presented|||1.4136|1.1013|
71776285|NCT02927262|143051979|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.163|TWO_SIDED|95.0|0.407|1.336|||Log Rank||HR \& 95% CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors:age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.336|0.407|0.163
71776286|NCT02927262|143051980|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.627||95.0|0.54|2.364|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||2.364|0.540|0.627
71776287|NCT02927262|143051981|SUPERIORITY||Hazard Ratio (HR)|0.862||||0.296|TWO_SIDED|95.0|0.51|1.455|||Log Rank||HR \& 95%CI are based on CHM. Assuming proportional hazards, HR \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm. Stratification factors: age, geographic region, presence of MRD at screening, use of FLT3 inhibiting agents per IRT.|||1.455|0.510|0.296
71776288|NCT02927262|143051982|SUPERIORITY|||||||0.97||||||2-sided P-value from analysis of covariance (ANCOVA) including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 3||||0.970
71776289|NCT02927262|143051982|SUPERIORITY|||||||0.415||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 6||||0.415
71776290|NCT02927262|143051982|SUPERIORITY|||||||0.271||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 12||||0.271
71776291|NCT02927262|143051982|SUPERIORITY|||||||0.179||||||2-sided P-value from ANCOVA including treatment, age group, geographic region and use of FLT3-inhibiting agents per IRT as fixed factors and baseline score as covariate.|ANCOVA|||Month 24/EoT||||0.179
71776292|NCT01697358|143051990|SUPERIORITY|||||||0.036|||||||Z-test using unpooled standard deviation|||||||0.036
71776293|NCT01697358|143051991|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
71776294|NCT01697358|143051992|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.||||||< 0.001
71776295|NCT01697358|143051993|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.||||||< 0.001
71776296|NCT01697358|143051994|SUPERIORITY||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.||||||< 0.001
71776297|NCT01697358|143051995|SUPERIORITY||||||<|0.001|||||||Z-test using unpooled standard deviation|||||||< 0.001
71776298|NCT01460368|143051996|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|||||TWO_SIDED|90.0|-1.38|2.63|||||Treatment comparison at 2 hours.|||2.63|-1.38|
71776299|NCT01460368|143051996|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.69|||||TWO_SIDED|90.0|1.67|5.71|||||Treatment comparison at 4 hours.|||5.71|1.67|
71776300|NCT01460368|143051996|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.14|||||TWO_SIDED|90.0|7.12|11.16|||||Treatment comparison at 6 hours.|||11.16|7.12|
71776301|NCT01460368|143051996|SUPERIORITY_OR_OTHER||Least Squares Means Difference|9.08|||||TWO_SIDED|90.0|7.1|11.07|||||Treatment comparison at 8 hours.|||11.07|7.10|
71834071|NCT02554786|143172202|SUPERIORITY||LS Mean|-0.203|STANDARD_ERROR_OF_MEAN|0.0318|<|0.001|TWO_SIDED|95.0|-0.266|-0.141|||MMRM|||Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 \& 150/320 μg and MF 400 \& 800 μg derived by weighting treatment groups equally.||-0.141|-0.266|<0.001
71776302|NCT01460368|143051996|SUPERIORITY_OR_OTHER||Least Squares Means Difference|-0.15|||||TWO_SIDED|90.0|-2.14|1.85|||||Treatment comparison at 12 hours.|||1.85|-2.14|
71776303|NCT01460368|143051996|SUPERIORITY_OR_OTHER||Least Squares Means Difference|3.63|||||TWO_SIDED|90.0|1.63|5.63|||||Treatment comparison at 24 hours.|||5.63|1.63|
71776304|NCT01460368|143051997|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|8.07|||||TWO_SIDED|90.0|5.21|10.94|||||Treatment comparison at 2 hours.|||10.94|5.21|
71776305|NCT01460368|143051997|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|7.69|13.43|||||Treatment comparison at 4 hours.|||13.43|7.69|
71776306|NCT05055453|143052000|OTHER|A Shapiro Wilks test was used to test for normal distribution of the data.|||||<|0.001||||||"Result for comparison between automatic only and preferred app settings."|Durbin-Conover Pairwise Comparison|||||||<0.001
71776307|NCT05055453|143052000|OTHER||||||<|0.001||||||"Result of comparison between preferred app setting and extreme app setting"|Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||< 0.001
71776308|NCT05055453|143052000|OTHER|"Result of comparison between automatic only and extreme app setting."||||||0.002|||||||Durbin-Conover Pairwise Comparison|||A Shapiro Wilks test was used to test for normal distribution of the data.||||0.002
71776309|NCT05055453|143052001|OTHER|Analysis of first home trial|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71776310|NCT05055453|143052001|OTHER||||||<|0.001|||||||t-test, 2 sided|||Analysis of second home trial||||<.001
71776311|NCT01224665|143052002|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.86|1.4||Using an intention-to-treat analysis, we specified a stratified log-rank test with a one-sided alpha of 0.025.|Log Rank|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|3-year DFS estimates of 55% among participants undergoing SLND and 65% undergoing ELND were used to estimate the target HR. Assuming exponential DFS distribution, 5 years of enrollment, 3 years of follow-up, and 564 eligible participants, the trial would have 85% power to detect a 28% lower risk of recurrence or death with ELND than SLND.||1.40|0.86|0.45
71776312|NCT01224665|143052003|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.88|1.45|||||Adjustments were made for the following stratification factors: neoadjuvant chemotherapy, clinical T stage, and Zubrod performance score.|We assumed that the standard lymphadenectomy arm has 5-year survival of 55%, so we had 83% statistical power to detect a hazard ratio of 0.72 (55% vs. 65% survival at 5 years).||1.45|0.88|
71834072|NCT02554786|143172203|SUPERIORITY||LS Mean|0.136|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.09|0.183|||MMRM|||||0.183|0.090|<0.001
71834073|NCT02554786|143172203|SUPERIORITY||LS Mean|0.209|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.163|0.255|||MMRM|||||0.255|0.163|<0.001
71834074|NCT02554786|143172203|SUPERIORITY||LS Mean|0.048|STANDARD_ERROR_OF_MEAN|0.0234||0.04|TWO_SIDED|95.0|0.002|0.094|||MMRM|||||0.094|0.002|0.04
71834075|NCT02554786|143172204|SUPERIORITY||LS Mean|0.132|STANDARD_ERROR_OF_MEAN|0.0193|<|0.001|TWO_SIDED|95.0|0.094|0.17|||MMRM|||Day 30||0.170|0.094|<0.001
71776313|NCT02080637|143052021|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.5||0.01|TWO_SIDED||||||Paired t-test|||Baseline versus 2 hours post-ambrisentan||||0.01
71776314|NCT02080637|143052022|OTHER||Slope|-27.0||||0.94|TWO_SIDED|95.0|-775.0|723.0|||Regression, Linear|||||723|-775|0.94
71776315|NCT02080637|143052023|OTHER||Slope|1.2||||0.61|TWO_SIDED|95.0|-3.9|6.3|||Regression, Linear|||||6.3|-3.9|0.61
71776316|NCT02770170|143052024|OTHER|||||||0.7271||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod quadratic model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7271
71776317|NCT02770170|143052024|OTHER|||||||0.6415||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod sigmoidal Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6415
71776318|NCT02770170|143052024|OTHER|||||||0.7367||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod Emax model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.7367
71776319|NCT02770170|143052024|OTHER|||||||0.6624||||||An alpha of 0.20 was used for one-sided test. The MCPMod procedure adjusts for multiplicity.|MCPMod exponential model fit|||Multiple comparison procedures and modelling (MCPmod) techniques for logistic regression was used.||||0.6624
71776320|NCT02770170|143052024|OTHER||Risk Difference (RD)|-10.0||||0.4645|TWO_SIDED|80.0|-27.292|7.288|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||7.288|-27.292|0.4645
71776321|NCT02770170|143052024|OTHER||Risk Difference (RD)|-3.38||||0.8084|TWO_SIDED|80.0|-21.204|14.451|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||14.451|-21.204|0.8084
71776322|NCT02770170|143052024|OTHER||Risk Difference (RD)|-3.77||||0.7398|TWO_SIDED|80.0|-18.364|10.832|||Regression, Logistic|include treatment and covariates, race (Asian or non-Asian), proteinuria at screening (\<3g/day or \>= 3g/day)|Confidence intervals calculated using delta method|||10.832|-18.364|0.7398
71776323|NCT02770170|143052025|OTHER||Risk Difference (RD)|-8.93||||0.5773|TWO_SIDED|80.0|-23.66|7.64|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.64|-23.66|0.5773
71776324|NCT02770170|143052025|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.59|29.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||29.03|-4.59|0.4013
71776325|NCT02770170|143052025|OTHER||Risk Difference (RD)|-2.5||||0.8965|TWO_SIDED|80.0|-15.98|11.1|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||11.10|-15.98|0.8965
71776326|NCT02770170|143052026|OTHER||Risk Difference (RD)|-19.64||||0.1476|TWO_SIDED|80.0|-35.38|-2.48|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-2.48|-35.38|0.1476
71776327|NCT02770170|143052026|OTHER||Risk Difference (RD)|12.5||||0.4013|TWO_SIDED|80.0|-4.2|26.86|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||26.86|-4.20|0.4013
71776328|NCT02770170|143052026|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-13.63|13.63|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||13.63|-13.63|
71776329|NCT02770170|143052027|OTHER||Risk Difference (RD)|-26.67||||0.0512|TWO_SIDED|80.0|-41.52|-9.42|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-9.42|-41.52|0.0512
71776330|NCT02770170|143052027|OTHER||Risk Difference (RD)|5.0||||0.7597|TWO_SIDED|80.0|-12.1|20.74|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||20.74|-12.10|0.7597
71776331|NCT02770170|143052027|OTHER||Risk Difference (RD)|-5.0||||0.7505|TWO_SIDED|80.0|-18.74|9.02|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||9.02|-18.74|0.7505
71776332|NCT02770170|143052028|OTHER||Risk Difference (RD)|-21.43||||0.1269|TWO_SIDED|80.0|-36.03|-4.41|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||-4.41|-36.03|0.1269
71776333|NCT02770170|143052028|OTHER||Risk Difference (RD)|5.0||||0.7889|TWO_SIDED|80.0|-12.24|21.62|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||21.62|-12.24|0.7889
71776334|NCT02770170|143052028|OTHER||Risk Difference (RD)|-12.5||||0.2906|TWO_SIDED|80.0|-25.99|1.68|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||1.68|-25.99|0.2906
71776335|NCT02770170|143052029|OTHER||Risk Difference (RD)|-9.64||||0.5687|TWO_SIDED|80.0|-25.79|7.45|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||7.45|-25.79|0.5687
71776336|NCT02770170|143052029|OTHER||Risk Difference (RD)|2.5||||0.9217|TWO_SIDED|80.0|-14.67|19.17|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||19.17|-14.67|0.9217
71776337|NCT02770170|143052029|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|80.0|-14.03|14.03|||Barnard test of association||Unadjusted absolute risk difference; Confidence intervals calculated using Newcombe method|||14.03|-14.03|
71776338|NCT02979197|143052050|NON_INFERIORITY|A two-sample t-test was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib (arm 1) was non-inferior to half of the effect achieved with Amlodipine+Placebo (arm 2). The primary efficacy endpoint was considered met if the lower limits of the 97.5% one-side confidence interval (CI) for the difference in SBPday change in arm 1 and 50% of the mean change in arm 2 was less than 0.||||||0.024|||||||t-test, 2 sided|||LOCF method was used. Primary efficacy analysis was based on the difference between the Amlodipine+Celecoxib and Amlodipine+Placebo (arms 1 and 2, respectively) in the mean change in SBPday from Baseline to final (Day 13), where a subject completed the 14-day treatment plan, or to Day 6, where a subject was withdrawn from treatment before the Day 13 dose but after the Day 6 dose, or to baseline, where a subject was withdrawn before the Day 6 dose.||||0.024
71834076|NCT02554786|143172204|SUPERIORITY||LS Mean|0.196|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.158|0.234|||MMRM|||Day 30||0.234|0.158|<0.001
71834077|NCT02554786|143172204|SUPERIORITY||LS Mean|0.035|STANDARD_ERROR_OF_MEAN|0.0192||0.064|TWO_SIDED|95.0|-0.002|0.073|||MMRM|||Day 30||0.073|-0.002|0.064
71776339|NCT02979197|143052051|OTHER|ANOVA F-test was used to compare the mean changes in body weight from baseline to end of treatment among the three treatment arms. The omni-bus test was to conclude if any differences existed.||||||0.006|||||||ANOVA|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in body weight was the 1st of the four secondary efficacy endpoints.||||0.006
71663944|NCT00270855|142841209|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71741303|NCT03078556|142994869|OTHER||Median Difference (Final Values)|0.8836|||||TWO_SIDED|90.0|0.8351|0.935|||||Median Difference of plasma 3TC has been presented|||0.9350|0.8351|
71741304|NCT03078556|142994870|OTHER||Ratio|0.8661|||||TWO_SIDED|90.0|0.7658|0.9796|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9796|0.7658|
71834078|NCT02554786|143172204|SUPERIORITY||LS Mean|0.122|STANDARD_ERROR_OF_MEAN|0.0201|<|0.001|TWO_SIDED|95.0|0.083|0.162|||MMRM|||Day 86||0.162|0.083|<0.001
71663945|NCT00270855|142841209|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71741305|NCT03078556|142994870|OTHER||Ratio|1.0442|||||TWO_SIDED|90.0|0.9951|1.0957|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.0957|0.9951|
71741306|NCT03078556|142994871|OTHER||Ratio|0.7544|||||TWO_SIDED|90.0|0.6736|0.8448|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8448|0.6736|
71741307|NCT03078556|142994871|OTHER||Ratio|1.0972|||||TWO_SIDED|90.0|1.0424|1.155|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.1550|1.0424|
71741308|NCT03078556|142994874|OTHER||Ratio|0.8654|||||TWO_SIDED|90.0|0.7629|0.9816|||||Ratio (Bfed/B) of plasma DTG has been presented|||0.9816|0.7629|
71741309|NCT03078556|142994874|OTHER||Ratio|1.0841|||||TWO_SIDED|90.0|0.9139|1.286|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.2860|0.9139|
71741310|NCT03078556|142994875|OTHER||Ratio|0.7657|||||TWO_SIDED|90.0|0.6702|0.8749|||||Ratio (Cfed/C) of plasma DTG has been presented|||0.8749|0.6702|
71741311|NCT03078556|142994875|OTHER||Ratio|1.197|||||TWO_SIDED|90.0|1.0869|1.3182|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.3182|1.0869|
71741312|NCT03078556|142994876|OTHER||Ratio|1.2929|||||TWO_SIDED|90.0|1.1281|1.4819|||||Ratio (Bfed/B) of plasma DTG has been presented|||1.4819|1.1281|
71741313|NCT03078556|142994876|OTHER||Ratio|1.2015|||||TWO_SIDED|90.0|1.1074|1.3036|||||Ratio (Bfed/B) of plasma 3TC has been presented|||1.3036|1.1074|
71741314|NCT03078556|142994877|OTHER||Ratio|1.469|||||TWO_SIDED|90.0|1.3009|1.6588|||||Ratio (Cfed/C) of plasma DTG has been presented|||1.6588|1.3009|
71741315|NCT03078556|142994877|OTHER||Ratio|1.1935|||||TWO_SIDED|90.0|1.1142|1.2785|||||Ratio (Cfed/C) of plasma 3TC has been presented|||1.2785|1.1142|
71741316|NCT01915173|142994910|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.01
71741317|NCT01915173|142994910|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Regression, Logistic|||All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.||||0.33
71741318|NCT02152761|142994912|SUPERIORITY||Treatment Group Ratio (BYM - Placebo)|1.057|||<|0.0001|TWO_SIDED|95.0|1.037|1.076|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.076|1.037|<.0001
71834079|NCT02554786|143172204|SUPERIORITY||LS Mean|0.184|STANDARD_ERROR_OF_MEAN|0.0202|<|0.001|TWO_SIDED|95.0|0.144|0.224|||MMRM|||Day 86||0.224|0.144|<0.001
71834080|NCT02554786|143172204|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.002|0.076|||MMRM|||Day 86||0.076|-0.002|0.063
71663946|NCT00270855|142841210|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663947|NCT00270855|142841211|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71741319|NCT02152761|142994912|SUPERIORITY||Treatment group rratio (BYM - Placebo)|1.043|||<|0.0001|TWO_SIDED|95.0|1.024|1.064|||Mixed Models Analysis||Holm-Bonferroni method: Used to adjust the Type I error for two comparisons (BYM338 700 mg/Placebo) at Week 24. No control for multiplicity was made at Week 12.|week 12||1.064|1.024|<.0001
71741320|NCT02152761|142994913|SUPERIORITY||LS Mean of Treatment Difference|-0.071||||0.1829|TWO_SIDED|95.0|-0.175|0.034||Treatment Difference (BYM-Placebo)|Mixed Models Analysis|||week 24||0.034|-0.175|0.1829
71741321|NCT02152761|142994913|SUPERIORITY||LS Mean of Treatment Difference|0.011||||0.8365|TWO_SIDED|95.0|-0.096|0.119|||Mixed Models Analysis|||week 24||0.119|-0.096|0.8365
71741322|NCT02152761|142994914|SUPERIORITY||LS Mean of Treatment Difference|-0.371||||0.5802|TWO_SIDED|95.0|-1.311|1.053|||Mixed Models Analysis|||week 24||1.053|-1.311|0.5802
71741323|NCT02152761|142994914|SUPERIORITY||LS Mean of the Treatment Difference|0.833||||0.0913|TWO_SIDED|95.0|-0.135|1.801|||Mixed Models Analysis|||week 24||1.801|-0.135|0.0913
71741324|NCT02152761|142994915|SUPERIORITY||Falls Rate Ratio|1.08||||0.8353|TWO_SIDED|95.0|0.53|2.21|||Negative binomial regression|||||2.21|0.53|0.8353
71741325|NCT02152761|142994915|SUPERIORITY||Falls Rate Ratio|1.58||||0.2015|TWO_SIDED|95.0|0.78|3.18|||Negative binomial regression|||||3.18|0.78|0.2015
71741326|NCT02152761|142994915|SUPERIORITY||Falls Rate Ratio|1.25||||0.3999|TWO_SIDED|95.0|0.52|3.0|||Negative binomial regression|||week 24||3.00|0.52|0.3999
71741327|NCT00887549|142994925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.015|||<|0.0001|TWO_SIDED|95.0|1.008|1.021|||Regression, Cox|The Cox model, based upon participant level data, included PFS as dependent variable and TS score in the nucleus as independent variable.||||1.021|1.008|<0.0001
71834081|NCT02554786|143172205|SUPERIORITY||LS Mean|0.142|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.119|0.164|||MMRM|||Day 1: 5 minutes||0.164|0.119|<0.001
71663948|NCT00270855|142841212|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71741328|NCT00759161|142994937|SUPERIORITY_OR_OTHER||||||<|0.001|||||||2-sided sign test|||||||< 0.001
71741329|NCT00479336|142994944|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.3167|TWO_SIDED|95.0|-0.061|0.02|||Regression, Linear|||A linear regression model using change in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset. The null hypothesis of whether the regression coefficient is zero (analysis using t-statistics) was tested at a two-tailed significance level of 0.05, and estimated values for the slope and 95% confidence interval were calculated.||0.020|-0.061|0.3167
71741330|NCT02631551|142994956|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.||||<0.0001
71741331|NCT02631551|142994956|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.||||0.0029
71741332|NCT02631551|142994956|SUPERIORITY|||||||0.0587|||||||Mixed Models Analysis|||GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.||||0.0587
71741333|NCT02631551|142994956|SUPERIORITY|||||||0.0755|||||||Mixed Models Analysis|||Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0755
71741334|NCT02631551|142994956|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.||||0.0043
71741335|NCT04112303|142994957|SUPERIORITY||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified efficacy threshold of 78% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.||||<0.001
71741336|NCT01318408|142994967|NON_INFERIORITY_OR_EQUIVALENCE|Assessing effects on cognition over time.||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants' scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.||||.01
71741337|NCT01318408|142994968|NON_INFERIORITY_OR_EQUIVALENCE|Assessing cognitive effects over time.||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Lower scores (negative change) indicate improvements on the ADAS-cog.||||||.02
71741338|NCT00377858|142994970|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.|Mean Difference (Net)|0.17||||0.097||95.0|-0.03|0.37|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).|Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.||0.37|-0.03|0.097
71741339|NCT00377858|142994971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.047||95.0|0.0|0.33||P-value for 12 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.33|0.00|0.047
71741340|NCT00377858|142994971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.043||95.0|0.01|0.35||P-value for 24 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|0.01|0.043
71741341|NCT00377858|142994971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.343||95.0|-0.1|0.29||P-value for 36 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.10|0.343
71741342|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.432||95.0||||P-value for Week 12: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.432
71741343|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value for 12 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.602
71741344|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value for 12 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.370
71741345|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value for 24 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.198
71741346|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value for 24 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.636
71741347|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value for 24 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.185
71834082|NCT02554786|143172205|SUPERIORITY||LS Mean|0.152|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.129|0.175|||MMRM|||Day 1: 5 minutes||0.175|0.129|<0.001
71834083|NCT02554786|143172205|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0116|<|0.001|TWO_SIDED|95.0|0.032|0.078|||MMRM|||Day 1: 5 minutes||0.078|0.032|<0.001
71834084|NCT02554786|143172205|SUPERIORITY||LS Mean|0.162|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.138|0.186|||MMRM|||Day 1: 15 minutes||0.186|0.138|<0.001
71834085|NCT02554786|143172205|SUPERIORITY||LS mean|0.174|STANDARD_ERROR_OF_MEAN|0.0123|<|0.001|TWO_SIDED|95.0|0.15|0.198|||MMRM|||Day 1: 15 minutes||0.198|0.150|<.001
71663949|NCT00270855|142841213|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663950|NCT00270855|142841214|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663951|NCT00270855|142841215|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71741348|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value for 36 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.393
71741349|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value for 36 Week: HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.739
71741350|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||P-value for 36 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.396
71741351|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.227||95.0||||P-value for Endpoint (LOCF): HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.227
71741352|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||P-value for Endpoint (LOCF): HbA1c \<7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.482
71741353|NCT00377858|142994972|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for Endpoint (LOCF): HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.||||||0.108
71741354|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.014||95.0|0.12|1.04||P-value for Baseline: Morning Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.04|0.12|0.014
71834086|NCT02554786|143172205|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0122|<|0.001|TWO_SIDED|95.0|0.02|0.068|||MMRM|||Day1: 15 minutes||0.068|0.02|<0.001
71834087|NCT02554786|143172205|SUPERIORITY||LS Mean|0.175|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.149|0.201|||MMRM|||Day 1: 30 minutes||0.201|0.149|<0.001
71663952|NCT00270855|142841215|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663953|NCT00270855|142841216|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71741355|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.735||95.0|-0.51|0.72||P-value for Baseline: Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.72|-0.51|0.735
71741356|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.051||95.0|0.0|1.08||P-value for Baseline: Midday Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.08|-0.00|0.051
71741357|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.536||95.0|-0.39|0.75||P-value for Baseline: Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.75|-0.39|0.536
71741358|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.793||95.0|-0.48|0.62||P-value for Baseline: Evening Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.48|0.793
71663954|NCT00270855|142841216|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663955|NCT00270855|142841217|NON_INFERIORITY_OR_EQUIVALENCE|Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71663956|NCT00270855|142841217|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663957|NCT00270855|142841218|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71663958|NCT00270855|142841218|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663959|NCT00270855|142841219|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71741359|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.693||95.0|-0.43|0.64||P-value for Baseline: Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.64|-0.43|0.693
71834088|NCT02554786|143172205|SUPERIORITY||LS Mean|0.185|STANDARD_ERROR_OF_MEAN|0.0132|<|0.001|TWO_SIDED|95.0|0.159|0.211|||MMRM|||Day 1: 30 minutes||0.211|0.159|<0.001
71834089|NCT02554786|143172205|SUPERIORITY||LS Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0132||0.038|TWO_SIDED|95.0|0.001|0.053|||MMRM|||Day 1: 30 minutes||0.053|0.001|0.038
71663960|NCT00270855|142841219|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71896184|NCT02495077|143314344|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.725|TWO_SIDED|95.0|-5.58|3.89|||Mixed Models Analysis|||Day 7. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 7 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from day 7 and months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 7. Random effects for the intercept and eGFR collection day were utilized in the model.||3.89|-5.58|0.725
71663961|NCT00270855|142841220|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71741360|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.499||95.0|-0.38|0.77||P-value for Baseline: 0300 Hours.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.77|-0.38|0.499
71741361|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|||<|0.001||95.0|0.26|0.92||P-value for 12 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.92|0.26|<0.001
71741362|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.278||95.0|-0.22|0.78||P-value for 12 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.78|-0.22|0.278
71741363|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.53||||0.009||95.0|0.14|0.93||P-value for 12 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.93|0.14|0.009
71741364|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.049||95.0|0.0|0.97||P-value for 12 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.97|0.00|0.049
71741365|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77|||<|0.001||95.0|0.35|1.18||P-value for 12 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.18|0.35|<0.001
71741366|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.17|||<|0.001||95.0|-1.63|-0.7||P-value for 12 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.70|-1.63|<0.001
71741367|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.506||95.0|-0.59|0.29||P-value for 12 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.59|0.506
71741368|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65|||<|0.001||95.0|0.31|0.99||P-value for 24 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.99|0.31|<0.001
71741369|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.094||95.0|-0.07|0.91||P-value for 24 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.91|-0.07|0.094
71741370|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.408||95.0|-0.24|0.59||P-value for 24 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.59|-0.24|0.408
71741371|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.351||95.0|-0.25|0.71||P-value for 24 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.71|-0.25|0.351
71741372|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.01||95.0|0.13|0.98||P-value for 24 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.98|0.13|0.010
71741373|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.029||95.0|-0.92|-0.05||P-value for 24 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.92|0.029
71741374|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.816||95.0|-0.45|0.35||P-value for 24 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.35|-0.45|0.816
71776340|NCT02979197|143052052|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered SBP24h to a greater degree than Amlodipine+Placebo.||||||0.826|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in SBP24h was the 2nd of the four secondary efficacy endpoints.||||0.826
71776341|NCT02979197|143052053|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered DBP24h to a greater degree than Amlodipine+Placebo.||||||0.5|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in DBP24h was the 3rd of the 4 secondary efficacy endpoints.||||0.500
71776342|NCT02979197|143052054|SUPERIORITY|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib improved creatinine clearance to a greater degree than Amlodipine+Placebo.||||||0.668|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in creatinine clearance was the 4th of 4 secondary efficacy endpoints.||||0.668
71776343|NCT02979197|143052055|SUPERIORITY|Differences in the occurrence of TEAEs between treatment arms were evaluated using Chi-square test.||||||0.675|||||||Chi-squared|Computed on the number of subjects who had at least one TEAE.||||||0.675
71776344|NCT02979197|143052055|SUPERIORITY|||||||0.555|||||||Regression, Logistic|TEAE (1=at least one TEAE occurred for the subject; 0=otherwise) as dependent variable and treatment as fixed effect.||||||0.555
71776345|NCT02979197|143052056|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification were treated as 0.||||0.226
71776346|NCT02979197|143052057|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification (BLQ) were treated as 0.04 ng/mL. Assignment of BLQ values to a nonzero number allowed computation of the log transformation. The selection of 0.04 ng/mL was based on the lower limit of quantification of the validated bioanalytical method (0.05 ng/mL) and selecting the next lowest number at the hundredth decimal place.||||0.215
71776347|NCT02979197|143052058|SUPERIORITY|||||||0.0005|||||||ANCOVA|Adjusted mean = -3.48 μmol/L; 95% confidence interval = -5.4 to -1.6||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Celecoxib arm from baseline to Day 14.||||0.0005
71776348|NCT02979197|143052058|SUPERIORITY|||||||0.075|||||||ANCOVA|Adjusted mean = -1.72 μmol/L; 95% confidence interval = -3.6 to 0.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Placebo arm from baseline to Day 14.||||0.0750
71776349|NCT02979197|143052058|SUPERIORITY|||||||0.4184|||||||ANCOVA|Adjusted mean = -1.92 μmol/L; 95% confidence interval = -6.6 to 2.8||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Placebo+Placebo arm from baseline to Day 14.||||0.4184
71776350|NCT02979197|143052058|SUPERIORITY|||||||0.2022|||||||ANCOVA|Adjusted mean = -1.76 μmol/L; 95% confidence interval = -4.5 to 1.0||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Amlodipine+Placebo arms.||||0.2022
71776351|NCT02979197|143052058|SUPERIORITY|||||||0.541|||||||ANCOVA|Adjusted mean = -1.56 μmol/L; 95% confidence interval = -6.6 to 3.5||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Placebo+Placebo arms.||||0.5410
71776352|NCT02979197|143052058|SUPERIORITY|||||||0.9397|||||||ANCOVA|Adjusted mean = 0.19 μmol/L; 95% confidence interval = -4.9 to 5.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Placebo and Placebo+Placebo arms.||||0.9397
71776353|NCT03467048|143052059|NON_INFERIORITY|Null hypothesis: McGrath Video Laryngoscopy is non-inferior to Macintosh direct laryngoscopy.|Odds Ratio (OR)|4.65|||<|0.01|TWO_SIDED|95.0|2.22|9.75|||t-test, 1 sided|||||9.75|2.22|<0.01
71776354|NCT03467048|143052060|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.3||||0.08|TWO_SIDED|0.975|0.04|2.28|||t-test, 1 sided|||||2.28|0.04|0.08
71776355|NCT03467048|143052061|NON_INFERIORITY|Null hypothesis: McGrath videolaryngoscopy is non-inferior to Direct laryngoscopy|Odds Ratio (OR)|0.87||||0.41|TWO_SIDED|97.5|0.1|7.77|||t-test, 1 sided|||||7.77|0.1|0.41
71776356|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Kruskal-Wallis|||For Vancomycin, all patients||||0.92
71776357|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, organisms not requiring vancomycin.||||0.032
71776358|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin-susceptible enterococci||||0.037
71776359|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Kruskal-Wallis|||For vancomycin, methicillin-susceptible Staphylococcus aureus.||||0.2
71776360|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||For nafcillin, oxacillin, or cefazolin.||||0.035
71776361|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||For piperacillin-tazobactam.||||0.012
71776362|NCT01898208|143052062|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Kruskal-Wallis|||For cefepime.||||0.56
71776363|NCT01898208|143052063|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the 3 groups.||||0.55
71663962|NCT00270855|142841220|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663963|NCT00270855|142841221|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71663964|NCT00270855|142841221|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663965|NCT00270855|142841222|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663966|NCT00270855|142841223|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663967|NCT00270855|142841224|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663968|NCT00270855|142841225|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663969|NCT00270855|142841226|OTHER|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663970|NCT00270855|142841227|NON_INFERIORITY_OR_EQUIVALENCE|We used a Mann-Whitney U test.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71741375|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49||||0.008||95.0|0.13|0.85||P-value for 36 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.85|0.13|0.008
71741376|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.438||95.0|-0.71|0.31||P-value for 36 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.31|-0.71|0.438
71741377|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.548||95.0|-0.54|0.29||P-value for 36 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.29|-0.54|0.548
71741378|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.964||95.0|-0.5|0.52||P-value for 36 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.52|-0.50|0.964
71663971|NCT00270855|142841228|NON_INFERIORITY_OR_EQUIVALENCE|A mann-whitney u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663972|NCT00270855|142841229|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group||||>0.05
71663973|NCT00270855|142841229|NON_INFERIORITY_OR_EQUIVALENCE|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group||||>0.05
71663974|NCT00270855|142841230|NON_INFERIORITY_OR_EQUIVALENCE|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention||||>0.05
71663975|NCT02152605|142841243|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.03|||<|0.001|TWO_SIDED|95.0|-6.28|-1.79|||Mixed Models Analysis|||||-1.79|-6.28|<0.001
71663976|NCT02152605|142841244|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.122|||<|0.001|TWO_SIDED|95.0|0.071|0.172|||Mixed Models Analysis|||||0.172|0.071|<0.001
71663977|NCT02152605|142841245|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
71663978|NCT02500043|142841246|OTHER||Hazard Ratio (HR)|0.6917||||0.0003|TWO_SIDED|95.0|0.5597|0.8548||One-sided P-Value.|Log Rank|||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified Cox's proportional hazard (CPH) model and survival was summarized using Kaplan Meier estimates.||0.8548|0.5597|0.0003
71741379|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.453||95.0|-0.27|0.6||P-value for 36 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.60|-0.27|0.453
71741380|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.096||95.0|-0.84|0.07||P-value for 36 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.84|0.096
71776364|NCT01898208|143052064|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate de-escalation comparing the 3 groups.||||<0.0001
71776365|NCT01898208|143052064|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||For time to first appropriate escalation comparing the 3 groups.||||0.04
71776366|NCT01898208|143052065|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Chi-squared|||This analysis compares the 3 groups.||||0.015
71776367|NCT01898208|143052066|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the FilmArray test to control arm.||||<0.0001
71776368|NCT01898208|143052066|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares FilmArray plus antimicrobial stewardship to the control arm.||||<0.0001
71776369|NCT01898208|143052067|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Kruskal-Wallis|||This analysis is to compare the three groups.||||0.79
71776370|NCT01898208|143052068|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Kruskal-Wallis|||||||0.90
71776371|NCT01898208|143052069|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||This analysis is a comparison of the 3 groups.||||0.62
71776372|NCT01898208|143052070|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Kruskal-Wallis|||This analysis compares the three groups.||||0.60
71776373|NCT01898208|143052071|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for all-cause mortality.||||0.74
71776374|NCT01898208|143052071|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Fisher Exact|||Comparison of the 3 groups for attributable mortality.||||0.42
71776375|NCT01898208|143052072|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Fisher Exact|||This analysis is a comparison across all three groups.||||0.82
71776376|NCT01898208|143052074|SUPERIORITY_OR_OTHER|||||||0.7789|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for total hospitalization costs.||||0.7789
71776377|NCT01898208|143052074|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for laboratory test cost.||||0.0006
71776378|NCT01898208|143052074|SUPERIORITY_OR_OTHER|||||||0.654|TWO_SIDED||||||Kruskal-Wallis|||Comparison between the 3 arms for antimicrobials costs.||||0.6540
71776379|NCT02436681|143052083|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71776380|NCT02436681|143052085|SUPERIORITY||||||=|0.0468|||||||t-test, 1 sided|||||||= 0.0468
71776381|NCT02436681|143052087|SUPERIORITY||||||=|0.014|||||||t-test, 1 sided|||||||=0.014
71776382|NCT02436681|143052088|SUPERIORITY||||||=|0.018|||||||t-test, 1 sided|||||||= 0.018
71776383|NCT01599832|143052100|OTHER|||||||0.083||||||P-value was from test of significance of log-transformed baseline K\^trans.|Regression, Cox|Multivariate model with adjustment for prior treatment, and clinical prognostic index (good/intermediate/poor) (n=16 had complete data)||||||0.083
71776384|NCT01739361|143052119|SUPERIORITY_OR_OTHER|||||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
71776385|NCT02443519|143052127|SUPERIORITY||Slope|1.6||||0.027|TWO_SIDED|95.0|-0.7|3.9||Significance threshold set a priori at .025 to adjust for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates greater reduction in the proportino of people with Severe MIDAS scores (Score \>=21) in the MBCT-M group vs. the WL/TAU group.|||3.9|-0.7|.027
71776386|NCT02443519|143052128|SUPERIORITY||Slope|14.1|||<|0.004|TWO_SIDED|95.0|0.8|21.8||Significance threshold set a priori at .025 to account for two co-primary outcomes.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|Positive slope indicated larger reductions in HDI in the MBCT-M group compared to the WL/TAU group.|||21.8|0.8|<.004
71776387|NCT02443519|143052129|SUPERIORITY||Slope|-0.05||||0.773|TWO_SIDED|95.0|-3.7|2.8||Threshold for statistical significance set a priori at .05.|Mixed Models Analysis|Key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with Treatment and Time in the model|A positive slope indicates greater reduction in headache days in the MBCT-M group vs. the WL/TAU group.|||2.8|-3.7|.773
71776388|NCT02443519|143052130|SUPERIORITY||Slope|0.01||||0.888|TWO_SIDED|95.0|-0.14|0.16||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in headache attack pain intensity in the MBCT-M group vs. WL/TAU.|||0.16|-0.14|.888
71776389|NCT02443519|143052131|SUPERIORITY||Slope|7.45||||0.035|TWO_SIDED|95.0|2.48|12.42|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Pain Catastrophizing Scale in the MBCT-M group vs. WL/TAU.|||12.42|2.48|.035
71776390|NCT02443519|143052132|SUPERIORITY||Slope|-3.05||||0.572|TWO_SIDED|95.0|-10.83|4.74|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Chronic Pain Acceptance in the MBCT-M group vs. WL/TAU.|||4.74|-10.83|.572
71776391|NCT02443519|143052133|SUPERIORITY||Slope|-2.65||||0.609|TWO_SIDED|95.0|-11.76|6.46||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a smaller decrease in the Five Factor Mindfulness Questionnaire in the MBCT-M group vs. WL/TAU.|||6.46|-11.76|.609
71776392|NCT02443519|143052134|SUPERIORITY||Slope|8.45||||0.022|TWO_SIDED|95.0|2.99|13.91||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in Headache Specific Locus of Control Scale score in the MBCT-M group vs. WL/TAU.|||13.91|2.99|.022
71834090|NCT02554786|143172205|SUPERIORITY||LS Mean|0.178|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.15|0.205|||MMRM|||Day 1: 1 hour||0.205|0.150|<0.001
71834091|NCT02554786|143172205|SUPERIORITY||LS Mean|0.205|STANDARD_ERROR_OF_MEAN|0.0139|<|0.001|TWO_SIDED|95.0|0.177|0.232|||MMRM|||Day 1: 1hour||0.232|0.177|<0.001
71834092|NCT02554786|143172205|SUPERIORITY||LS Mean|0.007|STANDARD_ERROR_OF_MEAN|0.0139||0.632|TWO_SIDED|95.0|-0.021|0.034|||MMRM|||Day 1: 1hour||0.034|-0.021|0.632
71834093|NCT02554786|143172205|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0192|<|0.001|TWO_SIDED|95.0|0.151|0.226|||MMRM|||Day 30: 5 minutes||0.226|0.151|<0.001
71834094|NCT02554786|143172205|SUPERIORITY||LS Mean|0.232|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.194|0.27|||MMRM|||Day 30: 5 minutes||0.270|0.194|<0.001
71776393|NCT02443519|143052135|SUPERIORITY||Slope|-2.01||||0.124|TWO_SIDED|95.0|-7.56|3.53||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A negative slope indicates a greater improvement in Headache Management Self-Efficacy Scale score in the MBCT-M group vs. WL/TAU.|||3.53|-7.56|.124
71776394|NCT02443519|143052136|SUPERIORITY||Slope|3.48||||0.017|TWO_SIDED|95.0|0.63|6.33||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Depression score in the MBCT-M group vs. WL/TAU.|||6.33|0.63|.017
71776395|NCT02443519|143052137|SUPERIORITY||Slope|2.82||||0.259|TWO_SIDED|95.0|-0.03|5.68||Threshold for significance set a priori at .05.|Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL.TAU) X Time (Month 1 vs 4) interaction with both Treatment and Time in the model.|A positive slope indicates a greater reduction in PROMIS-Anxiety score in the MBCT-M group vs. WL/TAU.|||5.68|-0.03|.259
71776396|NCT02443519|143052138|SUPERIORITY||Slope|-1.0||||0.007|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|The key test was the Treatment (MBCT-M vs. WL/TAU) X Time (Month 1 vs. 4) interaction with both Treatment and Time in the model.|A negative slope indicated a larger decrease in MIDI scores in the MBCT-M group vs. WL/TAU|||-0.3|-1.6|.007
71776397|NCT00932737|143052139|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0156|TWO_SIDED|95.0|-1.3|-0.1|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||-0.1|-1.3|0.0156
71776398|NCT00932737|143052140|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0512|TWO_SIDED|95.0|-1.2|0.0|||Mixed effect model||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|A model included fixed, categorical effects of treatment group, episode, interval and center, as well as the treatment-by-episode interaction, with the covariate of baseline intensity of Abdominal pain associated with cramping . An unstructured covariance structure was used to model the within-patient errors.||0.0|-1.2|0.0512
71776399|NCT00932737|143052141|OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0351|TWO_SIDED|95.0|-1.3|0.0|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide minus Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.0|-1.3|0.0351
71776400|NCT00932737|143052142|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3557|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA||The adjusted mean difference between Hyoscine butylbromide and Placebo was calculated.|The analysis of covariance (ANCOVA) was performed on the change from baseline to the last recorded rating of intensity for each treated episode of Abdominal pain associated with cramping (APC). The statistical model included the main effects of treatment, episode, and center as well as terms for the treatment-by-episode interaction, with baseline intensity of APC for the respective episode as a covariate.||0.4|-1.0|0.3557
71776401|NCT00932737|143052143|OTHER||Odds Ratio (OR)|1.071||||0.831|TWO_SIDED|95.0|0.572|2.004|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.004|0.572|0.831
71776402|NCT00932737|143052144|OTHER||Odds Ratio (OR)|1.222||||0.557|TWO_SIDED|95.0|0.626|2.387|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.387|0.626|0.557
71776403|NCT00932737|143052145|OTHER||Odds Ratio (OR)|0.737||||0.396|TWO_SIDED|95.0|0.365|1.49|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||1.490|0.365|0.396
71776404|NCT00932737|143052146|OTHER||Odds Ratio (OR)|1.336||||0.448|TWO_SIDED|95.0|0.632|2.827|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||2.827|0.632|0.448
71776405|NCT00932737|143052147|OTHER||Odds Ratio (OR)|2.474||||0.03|TWO_SIDED|95.0|1.093|5.604|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||5.604|1.093|0.030
71776406|NCT00932737|143052148|OTHER||Odds Ratio (OR)|1.654||||0.167|TWO_SIDED|95.0|0.81|3.378|||Regression, Logistic|Logistic regression included the main effects of treatment group, episode, and center.||||3.378|0.810|0.167
71776407|NCT00932737|143052149|OTHER|||||||0.256|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.2560
71776408|NCT00932737|143052150|OTHER|||||||0.5179|||||||Log Rank|Log rank test was used for comparison of Hyoscine butylbromide (Buscopan®) 20 mg group versus Placebo group.||||||0.5179
71776409|NCT03950791|143052160|SUPERIORITY||Mann-Whitney U|3864.0|STANDARD_ERROR_OF_MEAN|302.0||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons, p \< .05 used as threshold for statistical significance|Independent-samples Mann-Whitney U|No adjustments for multiple comparisons|Standardized Test Statistic = .139|Morphine equivalent dosage outcome variables were not normally distributed (skewness values between 4.5 and 4.8, kurtosis values between 25.7 and 30.0), which necessitated non-parametric analysis using independent-samples Mann-Whitney U Test||||.89
71776410|NCT02719327|143052163|SUPERIORITY||Slope|-2.18||||0.17|TWO_SIDED|95.0|-5.36|0.99||ASL values at 18 months were regressed on treatment group (IPE vs placebo) statistically controlling for age at baseline visit and ASL measured at baseline visit.|Regression, Linear|||The proposed study aims to investigate the effects of 18 months of IPE vs. placebo on regional cerebral blood flow in the bilateral posterior cingulate gyrus as measured by arterial spin-labeling MRI . IPE was hypothesized to improve regional cerebral blood flow over placebo after 18 months.||0.99|-5.36|0.17
71776411|NCT02719327|143052164|SUPERIORITY||Slope|0.11||||0.12|TWO_SIDED|95.0|-0.04|0.25|||Regression, Linear|18 month Beta-amyloid(1-42) was regressed on group (IPE vs placebo) and covariates age at baseline visit and Beta-amyloid(1-42) at baseline visit.|Placebo group is the reference group.|Beta-amyloid(1-42) concentration in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.25|-0.04|.12
71834095|NCT02554786|143172205|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0191||0.005|TWO_SIDED|95.0|0.016|0.091|||MMRM|||Day 30: 5 minutes||0.091|0.016|0.005
71741381|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.77||95.0|-0.51|0.37||P-value for 36 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.37|-0.51|0.770
71741382|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45||||0.01||95.0|0.11|0.8||P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.80|0.11|0.010
71776412|NCT02719327|143052164|SUPERIORITY||Slope|0.045||||0.05|TWO_SIDED|95.0|0.004|0.061|||Regression, Linear|log-transformed 18 month pTau181 was regressed on group (IPE vs placebo) and covariates age at baseline and log-transformed ptau181at baseline visit.|Placebo group is the reference group.|Phosphorylated tau (pTau181) measured in CSF was log-transformed prior to analysis to approximate a normal distribution.||0.061|0.004|0.05
71776413|NCT02719327|143052164|SUPERIORITY||Slope|0.046||||0.07|TWO_SIDED|95.0|-0.0008|0.106||18 months total Tau was regressed on Group (IPE vs placebo) and covariates age at baseline and total Tau at baseline.|Regression, Linear||Placebo group was the reference group.|Total tau was log-transformed prior to analysis to better approximate a normal distribution.||0.106|-0.0008|.07
71741383|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.201||95.0|-0.8|0.17||P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.17|-0.80|0.201
71741384|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.43||95.0|-0.57|0.24||P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.24|-0.57|0.430
71741385|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.814||95.0|-0.52|0.41||P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.41|-0.52|0.814
71741386|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.427||95.0|-0.24|0.57||P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.57|-0.24|0.427
71741387|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.009||95.0|-1.0|-0.14||P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.14|-1.00|0.009
71776414|NCT02719327|143052165|SUPERIORITY||Slope|0.006||||0.48|TWO_SIDED|95.0|-0.009|0.023|||Linear Mixed Effects model|Covariates included education level, gender, and age at baseline visit.|Placebo group was the reference group.|Four cognitive tests were standardized (baseline mean and standard deviation) prior to averaging to create the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) score. The final composite score was standardized again using baseline mean and standard deviation (range -3.15 to 3.10). Higher scores indicate better cognitive performance. A linear mixed effects model was used to determine if change in ADCS-PACC composite scores was modified by treatment group.||0.023|-0.009|.48
71776415|NCT01470859|143052168|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.||||||0.84
71776416|NCT01470859|143052168|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1||||||0.93
71741388|NCT00377858|142994973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.569||95.0|-0.51|0.28||P-value for Endpoint: 0300 Hours. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.28|-0.51|0.569
71741389|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.776||95.0|-0.14|0.19||P-value for Baseline MODD.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.19|-0.14|0.776
71741390|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.27||||0.737||95.0|-6.14|8.68||P-value for Baseline M-Value.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.68|-6.14|0.737
71741391|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.701||95.0|-0.19|0.13||P-value for 12 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.13|-0.19|0.701
71741392|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58||||0.4||95.0|-2.11|5.27||P-value for 12 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||5.27|-2.11|0.400
71776417|NCT01470859|143052168|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5||||||0.31
71663979|NCT02500043|142841247|OTHER||Hazard Ratio (HR)|0.5723|||||TWO_SIDED|95.0|0.4674|0.7008||||||TAS-102+BSC and Placebo+BSC were compared using the stratified log-rank test using the 3 randomization stratification factors (region, ECOG performance status, and prior treatment with ramucirumab). The hazard ratio was estimated using a stratified CPH model and survival was summarized using Kaplan Meier estimates.||0.7008|0.4674|
71741393|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.321||95.0|-0.26|0.09||P-value for 24 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.09|-0.26|0.321
71741394|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.52||||0.179||95.0|-1.16|6.21||P-value for 24 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||6.21|-1.16|0.179
71776418|NCT01470859|143052169|SUPERIORITY_OR_OTHER|||||||0.691|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups||||||0.691
71776419|NCT01470859|143052169|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups||||||0.706
71776420|NCT01470859|143052169|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups||||||0.635
71776421|NCT01470859|143052169|SUPERIORITY_OR_OTHER|||||||0.341|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups||||||0.341
71776422|NCT01470859|143052169|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups||||||0.049
71776423|NCT01470859|143052169|SUPERIORITY_OR_OTHER|||||||0.874|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups||||||0.874
71776424|NCT01470859|143052170|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1||||||0.720
71776425|NCT01470859|143052170|SUPERIORITY_OR_OTHER|||||||0.867|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5||||||0.867
71776426|NCT01470859|143052171|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|indenpendent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole group at V1||||||0.793
71776427|NCT01470859|143052171|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the H\&Y stages between levodopa and pramipexole groups at V5||||||0.430
71776428|NCT01470859|143052172|SUPERIORITY_OR_OTHER|||||||0.345|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2||||||0.345
71776429|NCT01470859|143052172|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||"p\<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5||||||0.410
71776430|NCT05268055|143052181|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||Group comparison of all participants.||||0.525
71663980|NCT03151408|142841254|SUPERIORITY|||||||0.8275||||||P-value stratified by cytogenetic risk factor and ECOG performance status|Log Rank|||||||0.8275
71663981|NCT03151408|142841255|OTHER|||||||0.1244|||||||Cochran-Mantel-Haenszel|||||||0.1244
71663982|NCT03151408|142841256|OTHER|||||||0.143|||||||Cochran-Mantel-Haenszel|||||||0.1430
71663983|NCT03151408|142841257|SUPERIORITY|||||||0.9977|||||||Cochran-Mantel-Haenszel|||||||0.9977
71663984|NCT03151408|142841258|OTHER|||||||0.9959|||||||Cochran-Mantel-Haenszel|||||||0.9959
71663985|NCT03151408|142841259|OTHER|||||||0.3502|||||||Cochran-Mantel-Haenszel|||||||0.3502
71663986|NCT03151408|142841260|OTHER|||||||0.0502|||||||Log Rank|||||||0.0502
71741395|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.573||95.0|-0.22|0.12||P-value for 36 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|-0.22|0.573
71776431|NCT05268055|143052181|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.045
71776432|NCT05268055|143052181|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.046
71776433|NCT05268055|143052182|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Group comparison of all participants.||||0.200
71776434|NCT05268055|143052182|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.075
71776435|NCT05268055|143052182|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.015
71663987|NCT03151408|142841262|OTHER|||||||0.4656|||||||Log Rank|||||||0.4656
71741396|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.95||||0.629||95.0|-4.79|2.9||P-value for 36 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||2.90|-4.79|0.629
71741397|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.25||95.0|-0.26|0.07||P-value for Endpoint MODD. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.07|-0.26|0.250
71741398|NCT00377858|142994974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.72||||0.362||95.0|-5.44|1.99||P-value for Endpoint M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||1.99|-5.44|0.362
71741399|NCT00377858|142994975|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Endpoint Hypoglycemic Episodes.|Fisher Exact|||||||0.094
71741400|NCT00377858|142994975|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Hypoglycemic Episodes.|Fisher Exact|||||||1.00
71741401|NCT00377858|142994975|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.430
71741402|NCT00377858|142994975|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Overall Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||1.00
71741403|NCT00377858|142994975|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.013
71776436|NCT05268055|143052183|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Group comparison of all participants.||||0.246
71776437|NCT05268055|143052183|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.151
71776438|NCT05268055|143052183|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.033
71663988|NCT03151408|142841263|OTHER|||||||0.7063|||||||Log Rank|||||||0.7063
71663989|NCT03151408|142841264|OTHER|||||||0.0592|||||||Log Rank|||||||0.0592
71776439|NCT05268055|143052184|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Group comparison of all participants.||||0.212
71776440|NCT05268055|143052184|SUPERIORITY|||||||0.893|||||||t-test, 2 sided|||Group comparison of participants less than age 33.||||0.893
71663990|NCT03151408|142841265|OTHER|||||||0.3835|||||||Log Rank|||||||0.3835
71663991|NCT03151408|142841266|OTHER|||||||0.7099|||||||Cochran-Mantel-Haenszel|||||||0.7099
71663992|NCT00926783|142841277|SUPERIORITY_OR_OTHER|||||||0.048||||||The p-value was based on Fisher's exact test. There were no adjustments for multiple comparisons.|Fisher Exact|||The null hypothesis is that rates of free from atrial arrhythmia for the two arms, Targeted and Generalized, are the same. The alternative hypothesis is that the rates are not the same. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.048
71741404|NCT00377858|142994975|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact|||||||0.756
71741405|NCT00377858|142994976|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Endpoint Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.022
71741406|NCT00377858|142994976|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Overall Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.218
71741407|NCT00377858|142994976|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.311
71741408|NCT00377858|142994976|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.615
71741409|NCT00377858|142994976|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.018
71741410|NCT00377858|142994976|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.||||||0.255
71741411|NCT00377858|142994977|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Overall Severe Hypoglycemic Episodes.|Fisher Exact|||||||0.416
71741412|NCT00377858|142994978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|||<|0.001||95.0|-0.12|-0.05||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-0.05|-0.12|<0.001
71776441|NCT05268055|143052184|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Group comparison of participants age 33 and greater.||||0.160
71776442|NCT05268055|143052185|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Healthcare Provider Cultural Competence measure.||||0.752
71776443|NCT05268055|143052185|SUPERIORITY|||||||0.493|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Ask, Understand, Remember Assessment.||||0.493
71776444|NCT05268055|143052185|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||Group comparison of self-rating scores on the Wake Forest Physician Trust Scale.||||0.085
71776445|NCT02053051|143052196|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71776446|NCT01854658|143052204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
71776447|NCT01854658|143052204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71663993|NCT00926783|142841278|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the total RF delivery times for both arms are equal. The alternative hypothesis is that the total RF delivery times are not equal. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.||||0.002
71663994|NCT02549027|142841285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.24|||||TWO_SIDED|90.0|0.12|0.47|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.47|0.12|
71663995|NCT02549027|142841285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.21|||||TWO_SIDED|90.0|0.1|0.41|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.41|0.10|
71663996|NCT02549027|142841285|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.15|||||TWO_SIDED|90.0|0.08|0.3|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.||0.30|0.08|
71663997|NCT02549027|142841286|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.05|||||TWO_SIDED|90.0|0.02|0.11|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.||0.11|0.02|
71663998|NCT02549027|142841289|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.67|1.07|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||1.07|0.67|
71741413|NCT00377858|142994978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||<|0.001||95.0|0.04|0.11||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.11|0.04|<0.001
71776448|NCT01854658|143052204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
71663999|NCT02549027|142841289|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.68|||||TWO_SIDED|90.0|0.54|0.86|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.86|0.54|
71664000|NCT02549027|142841289|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.95|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.||0.95|0.60|
71664001|NCT02549027|142841290|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.5|0.79|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.||0.79|0.50|
71664002|NCT02549027|142841291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|90.0|-12.01|17.2|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||17.20|-12.01|
71664003|NCT02549027|142841291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.28|||||TWO_SIDED|90.0|-9.33|19.88|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||19.88|-9.33|
71741414|NCT00377858|142994978|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.017||95.0|0.01|0.12||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.12|0.01|0.017
71776449|NCT01854658|143052204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71776450|NCT01854658|143052204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
71776451|NCT01854658|143052204|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71741415|NCT00377858|142994979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.96|||<|0.001||95.0|-9.65|-4.26||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||-4.26|-9.65|<0.001
71741416|NCT00377858|142994979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.05|||<|0.001||95.0|3.39|8.71||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||8.71|3.39|<0.001
71741417|NCT00377858|142994979|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2||||0.017||95.0|0.93|9.46||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||9.46|0.93|0.017
71741418|NCT00377858|142994980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|||<|0.001||95.0|0.24|0.42||P-value for Week 12.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.42|0.24|<0.001
71741419|NCT00377858|142994980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.003||95.0|0.07|0.36||P-value for Week 24.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.36|0.07|0.003
71741420|NCT00377858|142994980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.002||95.0|0.09|0.4||P-value for Week 30.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.40|0.09|0.002
71776452|NCT02160990|143052300|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
71776453|NCT02160990|143052301|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
71776454|NCT02160990|143052302|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANCOVA|||||||0.23
71776455|NCT03793556|143052310|OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|9.27||0.276|TWO_SIDED|95.0|-7.03|2.04|||Unpaired t test|||||2.04|-7.03|0.276
71776456|NCT03793556|143052311|OTHER|||||||0.0157|||||||ANOVA|The ANOVA model examined the entire curve profile.||||||0.0157
71776457|NCT03793556|143052321|OTHER|||||||0.0496|||||||Chi-squared|||||||0.0496
71741421|NCT00377858|142994980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.005||95.0|0.07|0.38||P-value for Week 36.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.38|0.07|0.005
71741422|NCT00377858|142994980|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.011||95.0|0.04|0.34||P-value for Endpoint. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.34|0.04|0.011
71741423|NCT00377858|142994981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.803||95.0|-0.8|0.62||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.|||0.62|-0.80|0.803
71741424|NCT04034004|142994998|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Pain ratings were collected while lying in the supine and after each straight leg rasise test (SLR 1; SLR 2). A 2 (group) X 2 (SLR 1-rest vs. SLR 2-meditation) X 2 (supine vs. SLR) X 3 (session) repeated measure mixed model ANOVA was conducted to determine if mindfulness and non-mindfulness meditation attenuate SLR induced pain through endogenous opioids. Simple effects tests tested significant main effects and interactions to test primary study hypotheses and between-group differences.||||.05
71741425|NCT01345188|142995004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|||||||Paired t test|||||||0.058
71741426|NCT01345188|142995005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048|||||||Paired t test|||||||0.048
71741427|NCT01345188|142995006|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Wilcoxon Signed rank|||||||>0.05
71741428|NCT01397461|142995007|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison"||||0.003
71776458|NCT03793556|143052323|OTHER|||||||0.0065|||||||ANOVA|||||||0.0065
71776459|NCT04612790|143052331|OTHER||Difference in percentage of responders|6.7||||0.509|TWO_SIDED|95.0|-10.9|24.29|||Logistic regression model with Firth adj|||Estimates were from a logistic regression model using the Firth adjustment (adj) that included treatment group, baseline disease severity (moderate, severe) and time of BP diagnosis (participants with newly diagnosed BP, participants with a previous diagnosis of BP who have relapsed) as categorical covariates.||24.29|-10.90|0.509
71776460|NCT00785928|143052337|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is p-value for the fitted ACR50 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.059
71834096|NCT02554786|143172205|SUPERIORITY||LS Mean|0.194|STANDARD_ERROR_OF_MEAN|0.0194|<|0.001|TWO_SIDED|95.0|0.156|0.232|||MMRM|||Day 30: 30 minutes||0.232|0.156|<0.001
71741429|NCT05729568|142995013|SUPERIORITY||Difference in least-squares means|-56.0||||0.1436|TWO_SIDED|95.0|-132.0|20.0|||ANCOVA||Difference in least-squares means (Diff in LSM), and its 95% CI were from ANCOVA model of change from baseline CD4 cell count with treatment as fixed effect and baseline CD4 cell count as a covariate.|||20|-132|0.1436
71741430|NCT04181762|142995026|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.0662|TWO_SIDED|95.0|-26.3|0.9|||Regression, Logistic||Difference from placebo and 95% CI are from a logistic regression model with treatment group, stratification factor (SoC) and race as factors and baseline UPCR as a covariate using marginal standardization method.|Complete Renal Response (CRR) at Week 52||0.9|-26.3|0.0662
71741431|NCT04181762|142995028|OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-23.7|8.4|||||95% Confidence Intervals (CIs) are constructed using the exact binomial test.|Partial Renal Response (PRR) at Week 52||8.4|-23.7|
71741432|NCT05919888|142995082|SUPERIORITY|||||||0.275|||||||Chi-squared|||||||0.275
71741433|NCT05919888|142995083|SUPERIORITY|||||||0.0056|||||||Chi-squared|||||||0.0056
71741434|NCT05919888|142995084|SUPERIORITY|||||||0.286|||||||Chi-squared|||||||0.286
71741435|NCT00555217|142995108|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.3|TWO_SIDED|95.0|0.7|1.12|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.12|0.70|0.30
71741436|NCT00555217|142995109|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.1|TWO_SIDED|95.0|0.58|1.05|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB|||1.05|0.58|0.10
71741437|NCT00367835|142995111|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71741438|NCT00367835|142995112|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71741439|NCT00367835|142995113|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71741440|NCT00367835|142995114|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71741441|NCT00367835|142995115|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71741442|NCT00367835|142995116|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||ANCOVA|||||||0.002
71741443|NCT00367835|142995117|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71741444|NCT01025830|142995124|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.87|1.38||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.38|0.87|
71741445|NCT01025830|142995124|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.31||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||1.31|0.95|
71776461|NCT00785928|143052337|SUPERIORITY_OR_OTHER||ED95|119.0||||0.042||95.0||||This is the p-value for the estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is ED95 in mg.||||||0.042
71741446|NCT01025830|142995124|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|0.8||||||90.0|0.65|0.99||p value not required for this analysis. What counts is the 90% confidence interval of the geometric mean ratio between the two formulation parameters.|Non-compartmental model|Mixed random effects model was used to assess difference between treatments and intra- and inter-subject variances.|the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.||0.99|0.65|
71741447|NCT01025830|142995125|NON_INFERIORITY_OR_EQUIVALENCE|same as for AUC|Geometric Mean Ratio|1.3||||||90.0|0.99|1.71||same as for AUC|Non-compartmental model|same as for AUC|same as AUC|Same as for AUC||1.71|0.99|
71741448|NCT01025830|142995125|NON_INFERIORITY_OR_EQUIVALENCE|same for all three drugs.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.23||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||1.23|0.95|
71741449|NCT01025830|142995125|NON_INFERIORITY_OR_EQUIVALENCE|Same for all three drugs.|Geometric Mean Ratio|0.8||||||90.0|0.63|0.98||Same for all three drugs.|Non-compartmental model|Same for all three drugs.|Same for all three drugs.|Same for all three drugs.||0.98|0.63|
71776462|NCT00785928|143052338|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||This is the p-value for the fitted ACR20 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose\^2) from the likelihood ratio test.|Linear-quadratic regression model|||||||0.044
71834097|NCT02554786|143172205|SUPERIORITY||LS Mean|0.253|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.214|0.291|||MMRM|||Day 30: 30 minutes||0.291|0.214|<0.001
71741450|NCT00264537|142995178|SUPERIORITY_OR_OTHER|||||||0.053||||||A positive test is concluded if there is a significant difference between golimumab+MTX and placebo+MTX and at least one of the pair-wise comparisons at a 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Group 1 vs combined Groups 3 and 4. The sample size of 150 patients per treatment group will provide \>98% power to detect a difference in ACR 50 response between treatment groups at alpha=0.05, assuming 50% of patients with screening C-reactive protein (CRP)\<1.5mg/dL, and the difference in ACR 50 response of 15-20% in patients with screening CRP\<1.5mg/dL and 20-25% in subjects with screening CRP\>=1.5mg/dL, between Groups 1 vs 3 or 4||||0.053
71741451|NCT00264537|142995178|SUPERIORITY_OR_OTHER|||||||0.042|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 3.||||0.042
71741452|NCT00264537|142995178|SUPERIORITY_OR_OTHER|||||||0.177|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 4.||||0.177
71741453|NCT00264537|142995178|NON_INFERIORITY_OR_EQUIVALENCE|This sample size (150 patients per treatment group) will provide approximately 85% power to claim non-inferiority of golimumab alone (Group 2) compared with MTX alone (Group 1) at alpha= 0.05 using a one-sided equivalence test assuming the proportion of golimumab alone (Group 2) treated patients with ACR 50 response is not less than 10% compared with proportion of patients with ACR 50 response in MTX alone (Group 1) treated group.|Difference in ACR 50 Response Rate(%)|3.3||||0.521||95.0|-6.8||The upper bound of 95% CI was not produced because it was not relevant to the pre-specified analysis||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)|The positive difference indicates in favor of golimumab+placebo compared to placebo+MTX; The upper bound of CI is not applicable.|"Null hypothesis: Group 2 is inferior to Group 1. Noninferiority of golimumab will be demonstrated if the lower bound of the 2-sided 95% CI is above -10%. The 10% non-inferiority margin was chosen because this difference is not clinically admissible. Under the above noted assumed response rates, this corresponds to preservation of at least 70% \[(33% - 10%)/33%\*100\] of the expected MTX benefit."|||-6.8|0.521
71741454|NCT00264537|142995179|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.011
71741455|NCT00264537|142995179|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
71741456|NCT00264537|142995179|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.028
71741457|NCT00264537|142995179|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.677
71776463|NCT00785928|143052338|SUPERIORITY_OR_OTHER||ED95|118.5||||0.005||95.0||||This p-value is for estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) of the ACR20 and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is the ED95 in mg.||||||0.005
71776464|NCT00785928|143052339|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.623
71776465|NCT00785928|143052339|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.160
71776466|NCT00785928|143052339|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.568
71776467|NCT00785928|143052339|SUPERIORITY_OR_OTHER|||||||0.633||95.0||||Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.633
71741458|NCT00264537|142995180|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.178
71741459|NCT00264537|142995180|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.250
71776468|NCT00785928|143052339|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.754
71776469|NCT00785928|143052339|SUPERIORITY_OR_OTHER|||||||0.289||95.0||||Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.289
71776470|NCT00785928|143052340|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.671
71834098|NCT02554786|143172205|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0192||0.026|TWO_SIDED|95.0|0.005|0.08|||MMRM|||Day 30: 30 minutes||0.08|0.005|0.026
71834099|NCT02554786|143172205|SUPERIORITY||LS Mean|0.19|STANDARD_ERROR_OF_MEAN|0.0196|<|0.001|TWO_SIDED|95.0|0.152|0.229|||MMRM|||Day 30: 1 hour||0.229|0.152|<0.001
71834100|NCT02554786|143172205|SUPERIORITY||LS Mean|0.258|STANDARD_ERROR_OF_MEAN|0.0198|<|0.001|TWO_SIDED|95.0|0.219|0.296|||MMRM|||Day 30: 1 hour||0.296|0.219|<0.001
71834101|NCT02554786|143172205|SUPERIORITY||LS Mean|0.037|STANDARD_ERROR_OF_MEAN|0.0194||0.059|TWO_SIDED|95.0|-0.001|0.075|||MMRM|||Day 30: 1 hour||0.075|-0.001|0.059
71834102|NCT02554786|143172205|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0204|<|0.001|TWO_SIDED|95.0|0.123|0.203|||MMRM|||Day 86: 5 minutes||0.203|0.123|<0.001
71834103|NCT02554786|143172205|SUPERIORITY||LS Mean|0.231|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|0.191|0.271|||MMRM|||Day 86: 5 minutes||0.271|0.191|<0.001
71664004|NCT02549027|142841291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.38|||||TWO_SIDED|90.0|-8.23|20.98|||||Difference is MK-1064 - placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.||20.98|-8.23|
71741460|NCT00264537|142995180|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.240
71741461|NCT00264537|142995180|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (\< 1.5 mg/dL; \>= 1.5 mg/dL)||||||0.339
71741462|NCT00264537|142995181|SUPERIORITY_OR_OTHER|||||||0.006||||||If this test is significant, a pairwise comparison between Group 3 and Group 1, and between Group 4 and Group 1 will be performed|ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; ≥ 1.5 mg/dL)||Null Hypothesis: No difference in vdH-S score comparing Groups 1 vs Groups 3 and 4 combined. The sample size of 150 subjects in each treatment group (Group 1, Group 3, Group 4) will provide \> 95% power to detect a difference in the vdH-S score between treatment groups using a 2-sided t-test on van der Waerden normal scores of change from baseline in vdH-S score at α = 0.05, assuming a mean change from baseline in vdH-S score of 3.5 for the placebo group and 1 for Groups 3 and 4.||||0.006
71741463|NCT00264537|142995181|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 3.||||0.015
71741464|NCT00264537|142995181|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (\< 1.5 mg/dL; \>= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 4.||||0.025
71741465|NCT00264537|142995182|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.003
71741466|NCT00264537|142995182|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.010
71741467|NCT00264537|142995182|SUPERIORITY_OR_OTHER|||||||0.014|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.014
71741468|NCT00264537|142995182|SUPERIORITY_OR_OTHER|||||||0.545|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores||||||0.545
71776471|NCT00785928|143052340|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.696
71776472|NCT00785928|143052340|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.367
71776473|NCT00785928|143052340|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.645
71776474|NCT00785928|143052340|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.944
71776475|NCT00785928|143052340|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.133
71664005|NCT02549027|142841292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|||||TWO_SIDED|90.0|-7.1|25.7|||||Difference is MK-6096 - placebo|Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed.||25.70|-7.10|
71741469|NCT03228212|142995185|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|2.0|||TWO_SIDED|95.0|1.16|9.09|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||9.09|1.16|
71741470|NCT03228212|142995186|NON_INFERIORITY|A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.00621|||TWO_SIDED|95.0|0.01|0.03|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.||0.03|0.01|
71741471|NCT03228212|142995187|NON_INFERIORITY|A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|proportion|0.992|||||TWO_SIDED|95.0|0.96|1.0|||Bayesian Methods|Bayesian Methods-Jefferys prior for binomial proportion was used to calculate 95% credible interval.||It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.||1|0.96|
71776476|NCT00785928|143052341|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||Pairwise comparison (1-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.457
71776477|NCT00785928|143052341|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||Pairwise comparison (1-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.874
71776478|NCT00785928|143052341|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Pairwise comparison (1-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.278
71776479|NCT00785928|143052341|SUPERIORITY_OR_OTHER|||||||0.357||95.0||||Pairwise comparison (1-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.357
71776480|NCT00785928|143052341|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||Pairwise comparison (1-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.271
71776481|NCT00785928|143052341|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Pairwise comparison (1-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.048
71776482|NCT00785928|143052342|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||This p-value is from 2-sided comparison of 1 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||0.875
71776483|NCT00785928|143052342|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 3 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
71776484|NCT00785928|143052342|SUPERIORITY_OR_OTHER|||||||1||95.0||||This p-value is from 2-sided comparison of 10 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact|||||||1.000
71776485|NCT00785928|143052342|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||This p-value is from a 2-sided comparison of 30 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.304
71776486|NCT00785928|143052342|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This p-value is from a 2-sided comparison of 60 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.489
71776487|NCT00785928|143052342|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||This p-value is from a 2-sided comparison of 120 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared|||||||0.091
71776488|NCT00785928|143052343|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.746
71776489|NCT00785928|143052343|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.393
71776490|NCT00785928|143052343|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.549
71776491|NCT00785928|143052343|SUPERIORITY_OR_OTHER|||||||0.619||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.619
71776492|NCT00785928|143052343|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.893
71776493|NCT00785928|143052343|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.066
71776494|NCT00785928|143052344|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.583
71776495|NCT00785928|143052344|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.311
71776496|NCT00785928|143052344|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.752
71776497|NCT00785928|143052344|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.737
71776498|NCT00785928|143052344|SUPERIORITY_OR_OTHER|||||||0.522||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.522
71776499|NCT00785928|143052344|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.073
71776500|NCT00785928|143052345|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.969
71776501|NCT00785928|143052345|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.352
71776502|NCT00785928|143052345|SUPERIORITY_OR_OTHER|||||||0.406||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.406
71776503|NCT00785928|143052345|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.266
71664006|NCT01421511|142841301|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-3.0|8.2|||||Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.|||8.2|-3.0|
71776504|NCT00785928|143052345|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.708
71776505|NCT00785928|143052345|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.012
71776506|NCT00785928|143052346|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.880
71776507|NCT00785928|143052346|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.575
71776508|NCT00785928|143052346|SUPERIORITY_OR_OTHER|||||||0.992||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.992
71776509|NCT00785928|143052346|SUPERIORITY_OR_OTHER|||||||0.646||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.646
71776510|NCT00785928|143052346|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.054
71776511|NCT00785928|143052346|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA|||||||0.472
71776512|NCT00785928|143052347|SUPERIORITY_OR_OTHER|||||||0.952||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.952
71776513|NCT00785928|143052347|SUPERIORITY_OR_OTHER|||||||0.085||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.085
71776514|NCT00785928|143052347|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.143
71776515|NCT00785928|143052347|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.242
71776516|NCT00785928|143052347|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.317
71776517|NCT00785928|143052347|SUPERIORITY_OR_OTHER|||||||0.456||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.456
71776518|NCT00785928|143052348|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.833
71776519|NCT00785928|143052348|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.826
71776520|NCT00785928|143052348|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.091
71776521|NCT00785928|143052348|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.127
71776522|NCT00785928|143052348|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.243
71776523|NCT00785928|143052348|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA|||||||0.037
71776524|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.562||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.562
71664007|NCT01421511|142841302|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-6.1|4.1||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.1|-6.1|
71776525|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.539
71776526|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.304
71776527|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.832
71776528|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.010
71776529|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P-value for physical health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.980
71776530|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.569
71664008|NCT01421511|142841303|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-8.8|0.3|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||0.3|-8.8|
71664009|NCT01421511|142841304|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-4.8|5.3|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||5.3|-4.8|
71776531|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.953
71776532|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.647||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.647
71776533|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.507||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.507
71776534|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.821
71776535|NCT00785928|143052349|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P-value for mental health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA|||||||0.045
71776536|NCT00785928|143052352|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||Pairwise (2-sided) comparisons of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.236
71776537|NCT00785928|143052352|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Pairwise (2-sided) comparisons of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.038
71776538|NCT00785928|143052352|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||Pairwise (2-sided) comparisons of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
71776539|NCT00785928|143052352|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Pairwise (2-sided) comparisons of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.005
71776540|NCT00785928|143052352|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||Pairwise (2-sided) comparisons of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.734
71776541|NCT00785928|143052352|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||Pairwise (2-sided) comparisons of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA|||||||0.035
71776542|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.901||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.901
71776543|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.840
71776544|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.882
71776545|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.225
71776546|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.340
71776547|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-value for IgG. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.850
71776548|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.447
71776549|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.909||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.909
71776550|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.152
71776551|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.023
71776552|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.004
71776553|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for IgM. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.017
71776554|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.944
71776555|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.677
71776556|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.053
71776557|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.061
71776558|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.025
71776559|NCT00785928|143052353|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for IgA. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA|||||||0.030
71834104|NCT02554786|143172205|SUPERIORITY||LS Mean|0.055|STANDARD_ERROR_OF_MEAN|0.0203||0.007|TWO_SIDED|95.0|0.015|0.095|||MMRM|||Day 86: 5minutes||0.095|0.015|0.007
71834105|NCT02554786|143172205|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0203|<|0.001|TWO_SIDED|95.0|0.14|0.219|||MMRM|||Day 86: 30 minutes||0.219|0.140|<0.001
71834106|NCT02554786|143172205|SUPERIORITY||LS Mean|0.252|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.211|0.292|||MMRM|||Day 86: 30 minutes||0.292|0.211|<0.001
71664010|NCT01421511|142841305|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.7|0.2|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||0.2|-7.7|
71664011|NCT01421511|142841306|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.2|||||TWO_SIDED|95.0|-3.3|5.6|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.||5.6|-3.3|
71664012|NCT01421511|142841307|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-3.2|4.9|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.||4.9|-3.2|
71664013|NCT02814890|142841352|OTHER|difference test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Sample size: Based on our previous data, pain score at rest 48 hours postoperatively when using ropivacaine only was of 2.8 with a standard deviation of 1.4. Assuming a decrease of pain score by 1.1 being clinically significant, twenty six patents in each group would be required for a study power of 80% (α=0.05,β=0.2). Considering possible dropouts, we aimed at recruiting 30 patients in each group with a total of 60 patients.||||0.001
71776560|NCT00408629|143052361|SUPERIORITY_OR_OTHER|||||||0.019||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.019
71776561|NCT00408629|143052362|SUPERIORITY_OR_OTHER|||||||0.004||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.||||0.004
71776562|NCT00408629|143052363|SUPERIORITY_OR_OTHER|||||||0.047||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.047
71776563|NCT00408629|143052364|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
71834107|NCT02554786|143172205|SUPERIORITY||LS Mean|0.038|STANDARD_ERROR_OF_MEAN|0.0202||0.057|TWO_SIDED|95.0|-0.001|0.078|||MMRM|||Day 86: 30 minutes||0.078|-0.001|0.057
71834108|NCT02554786|143172205|SUPERIORITY||LS Mean|0.187|STANDARD_ERROR_OF_MEAN|0.0205|<|0.001|TWO_SIDED|95.0|0.147|0.227|||MMRM|||Day 86: 1 hour||0.227|0.147|<0.001
71664014|NCT02814890|142841353|OTHER|difference test|Kendall's tau-b correlation coefficient|0.47|||||TWO_SIDED|||||||||||||
71664015|NCT02814890|142841355|SUPERIORITY||Risk Ratio (RR)|0.64|||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71664016|NCT00469144|142841379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants in CR||||0.9
71664017|NCT00469144|142841379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||100 Days, Between Arms: Participants not in CR||||0.4
71664018|NCT00469144|142841379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants in CR||||0.7
71664019|NCT00469144|142841379|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1 Year, Between Arms: Participants not in CR||||0.05
71664020|NCT01775189|142841385|SUPERIORITY_OR_OTHER||Least Squares (LS) mean Difference|9.5||||0.0001|TWO_SIDED|95.0|4.8|14.2||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.2|4.8|0.0001
71664021|NCT01775189|142841385|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|95.0|-37.0|-27.6||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-27.6|-37.0|<0.0001
71834109|NCT02554786|143172205|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0208|<|0.001|TWO_SIDED|95.0|0.208|0.289|||MMRM|||Day 86: 1 hour||0.289|0.208|<0.001
71834110|NCT02554786|143172205|SUPERIORITY||LS Mean|0.043|STANDARD_ERROR_OF_MEAN|0.0205||0.037|TWO_SIDED|95.0|0.003|0.083|||MMRM|||Day 86: 1hour||0.083|0.003|0.037
71834111|NCT02554786|143172205|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.121|0.206|||MMRM|||Day 183: 5 minutes||0.206|0.121|<0.001
71834112|NCT02554786|143172205|SUPERIORITY||LS Mean|0.243|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.2|0.286|||MMRM|||Day 183: 5 minutes||0.286|0.200|<0.001
71776564|NCT00408629|143052365|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
71664022|NCT01775189|142841385|SUPERIORITY_OR_OTHER||LS Mean Difference|9.1||||0.0002|TWO_SIDED|95.0|4.5|13.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.8|4.5|0.0002
71664023|NCT01775189|142841385|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.8806|TWO_SIDED|95.0|-5.0|4.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|-5.0|0.8806
71664024|NCT01775189|142841385|SUPERIORITY_OR_OTHER||LS Mean Difference|41.4|||<|0.0001|TWO_SIDED|95.0|36.8|46.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.1|36.8|<0.0001
71776565|NCT00408629|143052366|SUPERIORITY_OR_OTHER||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||<0.001
71664025|NCT01775189|142841385|SUPERIORITY_OR_OTHER||LS Mean Difference|41.8|||<|0.0001|TWO_SIDED|95.0|37.1|46.4||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|37.1|<0.0001
71834113|NCT02554786|143172205|SUPERIORITY||LS Mean|0.044|STANDARD_ERROR_OF_MEAN|0.0216||0.041|TWO_SIDED|95.0|0.002|0.087|||MMRM|||Day 183: 5 minutes||0.087|0.002|0.041
71834114|NCT02554786|143172205|SUPERIORITY||LS Mean|0.176|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.133|0.22|||MMRM|||Day 183: 30 minutes||0.220|0.133|<0.001
71664026|NCT01775189|142841386|SUPERIORITY_OR_OTHER||LS Mean Difference|6.6||||0.2176|TWO_SIDED|95.0|-4.0|17.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-4.0|0.2176
71664027|NCT01775189|142841386|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-65.1|-44.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-44.1|-65.1|<0.0001
71664028|NCT01775189|142841386|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0||||0.3502|TWO_SIDED|95.0|-5.6|15.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.5|-5.6|0.3502
71664029|NCT01775189|142841386|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.7624|TWO_SIDED|95.0|-12.1|8.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.9|-12.1|0.7624
71664030|NCT01775189|142841386|SUPERIORITY_OR_OTHER||LS Mean Difference|59.6|||<|0.0001|TWO_SIDED|95.0|49.0|70.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|49.0|<0.0001
71664031|NCT01775189|142841386|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|50.6|71.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.7|50.6|<0.0001
71664032|NCT01775189|142841387|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|13.8|35.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.3|13.8|<0.0001
71664033|NCT01775189|142841387|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.7|||<|0.0001|TWO_SIDED|95.0|-72.6|-50.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-50.9|-72.6|<0.0001
71664034|NCT01775189|142841387|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0012|TWO_SIDED|95.0|7.4|29.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.1|7.4|0.0012
71834115|NCT02554786|143172205|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.215|0.303|||MMRM|||Day 183: 30 minutes||0.303|0.215|<0.001
71834116|NCT02554786|143172205|SUPERIORITY||LS Mean|0.04|STANDARD_ERROR_OF_MEAN|0.0221||0.071|TWO_SIDED|95.0|-0.003|0.083|||MMRM|||Day 183: 30 minutes||0.083|-0.003|0.071
71834117|NCT02554786|143172205|SUPERIORITY||LS Mean|0.18|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.137|0.223|||MMRM|||Day 183: 1 hour||0.223|0.137|<0.001
71834118|NCT02554786|143172205|SUPERIORITY||LS Mean|0.259|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.215|0.302|||MMRM|||Day 183: 1 hour||0.302|0.215|<0.001
71776566|NCT00408629|143052367|SUPERIORITY_OR_OTHER|||||||0.032||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure were needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.032
71776567|NCT00408629|143052368|SUPERIORITY_OR_OTHER|||||||0.009||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.009
71776568|NCT00408629|143052369|SUPERIORITY_OR_OTHER|||||||0.013||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.013
71776569|NCT00408629|143052370|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
71834119|NCT02554786|143172205|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.0218||0.071|TWO_SIDED|95.0|-0.003|0.082|||MMRM|||Day 183: 1 hour||0.082|-0.003|0.071
71664035|NCT01775189|142841387|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.2507|TWO_SIDED|95.0|-17.2|4.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.5|-17.2|0.2507
71664036|NCT01775189|142841387|SUPERIORITY_OR_OTHER||LS Mean Difference|79.9|||<|0.0001|TWO_SIDED|95.0|69.2|90.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.7|69.2|<0.0001
71664037|NCT01775189|142841387|SUPERIORITY_OR_OTHER||LS Mean Difference|86.3|||<|0.0001|TWO_SIDED|95.0|75.4|97.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.1|75.4|<0.0001
71664038|NCT01775189|142841388|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.0015|TWO_SIDED|95.0|10.6|43.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.1|10.6|0.0015
71664039|NCT01775189|142841388|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-125.7|-93.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-93.0|-125.7|<0.0001
71664040|NCT01775189|142841388|SUPERIORITY_OR_OTHER||LS Mean Difference|21.4||||0.0109|TWO_SIDED|95.0|5.1|37.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|5.1|0.0109
71664041|NCT01775189|142841388|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.4||||0.5117|TWO_SIDED|95.0|-21.8|10.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-21.8|0.5117
71664042|NCT01775189|142841388|SUPERIORITY_OR_OTHER||LS Mean Difference|130.8|||<|0.0001|TWO_SIDED|95.0|114.5|147.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.0|114.5|<0.0001
71664043|NCT01775189|142841388|SUPERIORITY_OR_OTHER||LS Mean Difference|136.2|||<|0.0001|TWO_SIDED|95.0|119.8|152.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||152.5|119.8|<0.0001
71664044|NCT00856375|142841449|OTHER|Hazard Ratio and 95% CI from univariate Cox regression model|Hazard Ratio (HR)|0.645|||=|0.07|TWO_SIDED|95.0|0.4|1.041|||Log Rank|||||1.041|0.4|= 0.07
71664045|NCT00856375|142841450|OTHER|Hazard ratio and 95% CI from univariate Cox regression model.|Hazard Ratio (HR)|0.91|||=|0.706|TWO_SIDED|95.0|0.557|1.486|||Log Rank|||||1.486|0.557|= 0.706
71664046|NCT00856375|142841451|OTHER|ORR 95% CI based on Exact (Clopper-Pearson) confidence limits. Odds ratio 95% CI based on asymptotic confidence limits.|Odds Ratio (OR)|2.054|||=|0.676|TWO_SIDED|95.0|0.355|11.9|||Fisher Exact|||||11.9|0.355|= 0.676
71664047|NCT00856375|142841452|SUPERIORITY||||||=|0.018|||||||Log Rank|||||||= 0.018
71664048|NCT00741286|142841465|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||A linear mixed model for a repeated measures covariance pattern model with unstructured covariances within subjects was used. Two fixed effects were included: 1 between-subjects treatment effect (group: cilostazol, control) and 1 within-subject time effect (time: baseline, 14 days, 90 days). A possible difference in treatment across 14- and 90-day follow-up was analyzed by time x treatment interactions.||||<0.05
71664049|NCT00741286|142841465|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||To determine between-group differences of changes in the PIs at 14 and 90 days from the baseline study.||||<0.05
71664050|NCT00741286|142841466|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71664051|NCT02597127|142841479|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
71664052|NCT02597127|142841479|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
71664053|NCT02597127|142841479|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 500 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided|||||||<0.0001
71776570|NCT00408629|143052371|SUPERIORITY_OR_OTHER|||||||0.058||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.058
71776571|NCT00408629|143052372|SUPERIORITY_OR_OTHER|||||||0.028||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.028
71776572|NCT00408629|143052373|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
71776573|NCT00408629|143052374|SUPERIORITY_OR_OTHER|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.035
71776574|NCT00408629|143052375|SUPERIORITY_OR_OTHER|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.002
71776575|NCT00408629|143052376|SUPERIORITY_OR_OTHER|||||||0.007||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.007
71664054|NCT02597127|142841479|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 100 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
71664055|NCT02597127|142841479|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
71664056|NCT02597127|142841479|SUPERIORITY|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided|||||||<0.0001
71664057|NCT02922738|142841489|SUPERIORITY||Cox Proportional Hazard|0.92||||0.54|TWO_SIDED|95.0|0.7|1.21|||Regression, Cox|||||1.21|0.70|0.54
71664058|NCT02922738|142841490|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71664059|NCT00811928|142841502|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the 95% Confidence Interval for the difference in incidence defined as (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100% (posaconazole minus fluconazole) had to be \< 4 in order to be considered non-inferior. IFI occurred: proven+probable|Difference for the incidence|-5.88|||||TWO_SIDED|95.0|-12.21|0.25|||||Posaconazole minus fluconazole|||0.25|-12.21|
71664060|NCT00811928|142841503|SUPERIORITY_OR_OTHER||Percentage of Participants|4.27|||||TWO_SIDED|95.0|1.4|9.7|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||9.7|1.4|
71776576|NCT00408629|143052377|SUPERIORITY_OR_OTHER|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.||||0.006
71776577|NCT00191906|143052378|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.504
71664061|NCT00811928|142841503|SUPERIORITY_OR_OTHER||Percentage of Participants|13.68|||||TWO_SIDED|95.0|8.0|21.3|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||21.3|8.0|
71664062|NCT00811928|142841506|SUPERIORITY_OR_OTHER||Percentage of Participants|31.62|||||TWO_SIDED|95.0|23.3|40.9|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%.|||40.9|23.3|
71664063|NCT00811928|142841506|SUPERIORITY_OR_OTHER||Percentage of Participants|41.88|||||TWO_SIDED|95.0|32.8|51.4|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)\*100%|||51.4|32.8|
71664064|NCT00811928|142841507|SUPERIORITY_OR_OTHER||Percentage of Participants|2.56|||||TWO_SIDED|95.0|0.5|7.3|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||7.3|0.5|
71664065|NCT00811928|142841507|SUPERIORITY_OR_OTHER||Percentage of Participants|5.98|||||TWO_SIDED|95.0|2.4|11.9|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.|||11.9|2.4|
71664066|NCT04181723|142841529|SUPERIORITY||LSM difference|-3.1|STANDARD_ERROR_OF_MEAN|1.3||0.0175|TWO_SIDED|95.0|-5.7|-0.6|||Mixed-effects model for repeated measure|||||-0.6|-5.7|0.0175
71664067|NCT04181723|142841530|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.003|TWO_SIDED|95.0|-0.5|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-0.5|0.0030
71664068|NCT04181723|142841531|SUPERIORITY||LSM difference|1.0|STANDARD_ERROR_OF_MEAN|0.37||0.0064|TWO_SIDED|95.0|0.3|1.7|||Mixed-effects model for repeated measure|||||1.7|0.3|0.0064
71664069|NCT04181723|142841532|SUPERIORITY||LSM difference|-4.5|STANDARD_ERROR_OF_MEAN|4.67||0.3376|TWO_SIDED|95.0|-13.8|4.8|||ANCOVA|||||4.8|-13.8|0.3376
71664070|NCT04181723|142841533|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3649|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.3649
71664071|NCT04181723|142841534|SUPERIORITY||LSM difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2114|TWO_SIDED|95.0|-0.3|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.3|0.2114
71664072|NCT04181723|142841535|SUPERIORITY||LSM difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0257|TWO_SIDED|95.0|-0.6|0.0|||Mixed-effects model for repeated measure|||||0.0|-0.6|0.0257
71664073|NCT04181723|142841536|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9799|TWO_SIDED|95.0|-0.2|0.2|||Mixed-effects model for repeated measure|||||0.2|-0.2|0.9799
71664074|NCT04181723|142841537|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.5304|TWO_SIDED|95.0|-0.1|0.1|||Mixed-effects model for repeated measure|||||0.1|-0.1|0.5304
71664075|NCT04181723|142841538|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|1.4||0.5855|TWO_SIDED|95.0|-3.5|2.0|||ANCOVA|||||2.0|-3.5|0.5855
71664076|NCT04181723|142841539|SUPERIORITY||LSM difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2507|TWO_SIDED|95.0|-0.1|0.4|||Mixed-effects model for repeated measure|||||0.4|-0.1|0.2507
71664077|NCT03485365|142841555|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.18|STANDARD_DEVIATION|0.494|||TWO_SIDED|95.0|-2.15|-0.2|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||-0.20|-2.15|
71664078|NCT03485365|142841556|OTHER|Bayesian Repeated Measures Model|Median Difference (Net)|-1.09|STANDARD_DEVIATION|0.612|||TWO_SIDED|95.0|-2.29|0.12|||||Posterior median difference (GSK3858279 - Placebo) and 95% credible interval is presented.|||0.12|-2.29|
71664079|NCT03332979|142841597|OTHER|Multivariable regression analysis will be used to enable us to explore the impact of modifiable factors reflecting preparation for end of life on the MMCGI-SF.|||||<|0.05|||||||Regression, Linear||||Multivariable regression will be used to explore preparation for end of life on the MMCGI-SF. The analyses will use the MMCGI-SF as the dependent variable with five predictor variables (dementia knowledge \[DKAS\], Social support \[HLQ1\], Communication with healthcare professionals \[HLW4\], advance decisions and knowledge of end of life wishes of person with dementia. There will also be 10 confounders included in the model (gender of caregiver, living arrangement of person with dementia \[at home of a care home\], aged of person with dementia, dementia severity \[CDR\], change in closeness, religiosity \[DURAL\], deprivation and relationship of the carer to the person with dementia).|||<0.05
71664080|NCT05147324|142841605|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71664081|NCT05147324|142841606|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71664082|NCT05147324|142841614|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71664083|NCT01175031|142841695|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||signed-rank tests|||||||0.003
71664084|NCT00555360|142841699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.0||0.975|TWO_SIDED|95.0|-4.62|4.77|||Regression, Logistic|||||4.77|-4.62|.975
71664085|NCT00555360|142841700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.7||0.349|TWO_SIDED|95.0|-5.78|2.05|||Regression, Logistic|||||2.05|-5.78|.349
71664086|NCT00555360|142841701|SUPERIORITY_OR_OTHER||Difference in Percent|14.0|STANDARD_DEVIATION|6.0||0.007|TWO_SIDED|95.0|3.9|24.2|||Regression, Logistic|||||24.2|3.9|.007
71776578|NCT00191906|143052379|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.||||0.970
71664087|NCT03301623|142841711|SUPERIORITY||Mean Difference (Net)|-0.69||||0.541|TWO_SIDED|95.0|-2.9|1.52|||Mixed Models Analysis|Test is on interaction term between time (pre/post intervention) and treatment group (CDSvsPEAT) dummy variables in the regression model.|The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing pain interference over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.52|-2.9|.541
71776579|NCT00191906|143052380|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.579
71776580|NCT00191906|143052380|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.||||0.144
71776581|NCT00191906|143052381|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.005
71776582|NCT00191906|143052382|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.097
71776583|NCT00191906|143052383|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||0.003
71776584|NCT00191906|143052384|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
71776585|NCT00191906|143052385|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
71776586|NCT00191906|143052386|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
71776587|NCT00191906|143052387|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.||||<0.001
71776588|NCT00191906|143052388|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||||||0.094
71776589|NCT00191906|143052389|SUPERIORITY_OR_OTHER|||||||0.312||95.0||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction||||||0.312
71776590|NCT00191906|143052390|SUPERIORITY_OR_OTHER|||||||0.508||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.||||0.508
71776591|NCT00191906|143052391|SUPERIORITY_OR_OTHER|||||||0.769||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls||||0.769
71776592|NCT00191906|143052392|SUPERIORITY_OR_OTHER|||||||0.302||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.||||0.302
71776593|NCT00191906|143052392|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.663
71776594|NCT00191906|143052393|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.||||0.070
71664088|NCT03301623|142841712|SUPERIORITY||Odds Ratio (OR)|2.96||||0.019|TWO_SIDED|95.0|1.2|7.31|||Regression, Logistic|There were 69 providers with at least one CG-CAHPS response.|The interaction term describes the change in the PEAT group's scores in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving how satisfied patients feel over time after communicating with their physician about chronic pain treatment risks and benefits?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||7.31|1.20|.019
71741472|NCT03228212|142995188|NON_INFERIORITY|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|-0.0043|STANDARD_DEVIATION|0.0089|||TWO_SIDED|95.0|-0.0237|0.0129|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data|Mean difference calculated as Test - Control|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.||0.0129|-0.0237|
71741473|NCT03228212|142995189|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|3.69|10.74|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||10.74|3.69|
71741474|NCT03228212|142995190|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|3.3|STANDARD_DEVIATION|1.5|||TWO_SIDED|95.0|0.36|6.29|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.||6.29|0.36|
71741475|NCT01807299|142995191|OTHER||Mean Difference (Final Values)|5.0||||0.05|ONE_SIDED|5.0|||||Chi-squared, Corrected|||||||0.05
71741476|NCT00999544|142995196|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Area-under-the-curve (AUC) scores were derived from time course data and analyzed using two-factor ANOVA \[aprepitant dose (3 levels)x oxycodone dose (3 levels)\].~All analyses were conducted using SAS 9.1 for Windows (SAS Institute Inc., Cary, NC, USA) and were considered significant when P 0.05."||||<.05
71741477|NCT02309944|142995212|SUPERIORITY|||||||0.27|TWO_SIDED|95.0|||||Chi-squared|||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.27
71741478|NCT02309944|142995212|SUPERIORITY|||||||0.24|||||||Regression, Logistic|Multivariate Model (adjusted for ascites and previous laparotomy)||Negative Pressure Wound Therapy vs. Standard Wound Closure||||0.24
71741479|NCT01525615|142995235|SUPERIORITY_OR_OTHER||Treatment ratio|1.138|STANDARD_ERROR_OF_MEAN|0.063||0.0209|TWO_SIDED|95.0|1.02|1.269||Mixed effects Model for Repeated Measures (MMRM) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time), log10 (baseline endurance time) by test day interaction, and patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.269|1.020|0.0209
71741480|NCT01525615|142995235|SUPERIORITY_OR_OTHER||Treatment ratio|1.086|STANDARD_ERROR_OF_MEAN|0.061||0.1419|TWO_SIDED|95.0|0.973|1.213||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. This treatment comparison is the second one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.213|0.973|0.1419
71776595|NCT00191906|143052393|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.||||0.179
71776596|NCT00333801|143052396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71776597|NCT00333801|143052397|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71776598|NCT00333801|143052398|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d|0.93|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71776599|NCT03633617|143052407|SUPERIORITY||Difference in proportion|55.3|||<|0.0001|TWO_SIDED|95.0|39.58|71.04|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||71.04|39.58|<0.0001
71776600|NCT03633617|143052407|SUPERIORITY||Difference in proportion|56.0|||<|0.0001|TWO_SIDED|95.0|43.44|68.54|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||68.54|43.44|<0.0001
71776601|NCT03633617|143052407|SUPERIORITY||Difference in proportion|53.5|||<|0.0001|TWO_SIDED|95.0|41.2|65.79|||Cochran-Mantel-Haenszel||Difference is dupilumab minus placebo|||65.79|41.20|<0.0001
71776602|NCT03633617|143052408|SUPERIORITY||LS Mean Difference|-12.32||||0.0004|TWO_SIDED|95.0|-19.107|-5.537|||ANCOVA||Dupilumab group vs. Placebo|||-5.537|-19.107|0.0004
71776603|NCT03633617|143052408|SUPERIORITY||LS Mean Difference|-0.51||||0.8393|TWO_SIDED|95.0|-5.423|4.406|||ANCOVA||Dupilumab group vs. Placebo|||4.406|-5.423|0.8393
71776604|NCT03633617|143052408|SUPERIORITY||LS Mean Difference|-9.92|||<|0.0001|TWO_SIDED|95.0|-14.811|-5.022|||ANCOVA||Dupilumab group vs. Placebo|||-5.022|-14.811|<0.0001
71776605|NCT03633617|143052409|SUPERIORITY||LS Mean Difference|-68.26|||<|0.0001|TWO_SIDED|95.0|-86.896|-49.615|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-49.615|-86.896|<0.0001
71776606|NCT03633617|143052409|SUPERIORITY||LS Mean Difference|-79.22|||<|0.0001|TWO_SIDED|95.0|-103.098|-55.338|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-55.338|-103.098|<0.0001
71776607|NCT03633617|143052409|SUPERIORITY||LS Mean Difference|-88.62|||<|0.0001|TWO_SIDED|95.0|-112.194|-65.046|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-65.046|-112.194|<0.0001
71741481|NCT01525615|142995235|SUPERIORITY_OR_OTHER||Treatment ratio|1.047|STANDARD_ERROR_OF_MEAN|0.057||0.397|TWO_SIDED|95.0|0.941|1.166||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.166|0.941|0.3970
71741482|NCT01525615|142995236|SUPERIORITY_OR_OTHER||Tretament ratio|1.209|STANDARD_ERROR_OF_MEAN|0.119||0.0552|TWO_SIDED|95.0|0.996|1.467||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Since the hierarchical testing chain has been broken, even though this treatment comparison is included as the 3rd one in the alpha-protected hierarchical testing chain, this hypothesis test is descriptive only.||1.467|0.996|0.0552
71741483|NCT01525615|142995236|SUPERIORITY_OR_OTHER||Treatment ratio|1.211|STANDARD_ERROR_OF_MEAN|0.121||0.0562|TWO_SIDED|95.0|0.995|1.475||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean, 95% confidence limits transformed from log10 to original scale. SE was calculated using the delta method. This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.475|0.995|0.0562
71741484|NCT01525615|142995236|SUPERIORITY_OR_OTHER||Treatment ratio|0.998|STANDARD_ERROR_OF_MEAN|0.095||0.9822|TWO_SIDED|95.0|0.826|1.205||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.||1.205|0.826|0.9822
71776608|NCT03633617|143052410|SUPERIORITY||LS Mean Difference|-37.48||||0.0002|TWO_SIDED|95.0|-57.222|-17.745|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-17.745|-57.222|0.0002
71776609|NCT03633617|143052410|SUPERIORITY||LS Mean Difference|-4.35||||0.5243|TWO_SIDED|95.0|-17.734|9.038|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||9.038|-17.734|0.5243
71776610|NCT03633617|143052410|SUPERIORITY||LS Mean Difference|-22.89||||0.0008|TWO_SIDED|95.0|-36.272|-9.513|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-9.513|-36.272|0.0008
71776611|NCT03633617|143052411|SUPERIORITY||LS Mean Difference|-0.759|||<|0.0001|TWO_SIDED|95.0|-0.9061|-0.6127|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.6127|-0.9061|<0.0001
71776612|NCT03633617|143052411|SUPERIORITY||LS Mean Difference|-0.666|||<|0.0001|TWO_SIDED|95.0|-0.7773|-0.5538|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5538|-0.7773|<0.0001
71776613|NCT03633617|143052411|SUPERIORITY||LS Mean Difference|-0.682|||<|0.0001|TWO_SIDED|95.0|-0.7929|-0.5707|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5707|-0.7929|<0.0001
71776614|NCT03633617|143052412|SUPERIORITY||LS Mean Difference|-0.741|||<|0.0001|TWO_SIDED|95.0|-0.8842|-0.5978|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5978|-0.8842|<0.0001
71776615|NCT03633617|143052412|SUPERIORITY||LS Mean Difference|-0.661|||<|0.0001|TWO_SIDED|95.0|-0.7674|-0.554|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-0.5540|-0.7674|<0.0001
71776616|NCT03633617|143052412|SUPERIORITY||LS Mean Difference|-0.672|||<|0.0001|TWO_SIDED|95.0|-0.7778|-0.5655|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-0.5655|-0.7778|<0.0001
71776617|NCT03633617|143052413|SUPERIORITY||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-1.84|-3.91|<0.0001
71776618|NCT03633617|143052413|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-4.86|-3.02|||ANCOVA||Dupilumab 300 mg Q2W vs Placebo|||-3.02|-4.86|<0.0001
71776619|NCT03633617|143052413|SUPERIORITY||LS Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.77|-2.93|||ANCOVA||Dupilumab 300 mg QW vs Placebo|||-2.93|-4.77|<0.0001
71776620|NCT03633617|143052414|SUPERIORITY||Difference in proportion|57.5|||<|0.0001|TWO_SIDED|95.0|41.69|73.33|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||73.33|41.69|<0.0001
71776621|NCT03633617|143052414|SUPERIORITY||Difference in proportion|72.4|||<|0.0001|TWO_SIDED|95.0|61.05|83.7|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||83.70|61.05|<0.0001
71776622|NCT03633617|143052414|SUPERIORITY||Difference in proportion|74.9|||<|0.0001|TWO_SIDED|95.0|64.25|85.5|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||85.50|64.25|<0.0001
71776623|NCT03633617|143052415|SUPERIORITY||Hodges-Lehmann estimator|-2.25|||<|0.0001|TWO_SIDED|95.0|-2.72|-1.73|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.7300|-2.7200|<0.0001
71776624|NCT03633617|143052415|SUPERIORITY||Hodges-Lehmann estimator|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.42|-1.11|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1100|-2.4200|<0.0001
71776625|NCT03633617|143052415|SUPERIORITY||Hodges-Lehmann estimator|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.15|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.1500|-2.4400|<0.0001
71776626|NCT03633617|143052416|SUPERIORITY||Hodges-Lehmann estimator|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.27|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.2700|-1.7400|<0.0001
71776627|NCT03633617|143052416|SUPERIORITY||Hodges-Lehmann estimator|-1.255|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.05|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0500|-1.7300|<0.0001
71776628|NCT03633617|143052416|SUPERIORITY||Hodges-Lehmann estimator|-1.275|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.07|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|||-1.0700|-1.8200|<0.0001
71776629|NCT03633617|143052417|SUPERIORITY||Difference in proportion|21.9||||0.0017|TWO_SIDED|95.0|9.42|34.38|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||34.38|9.42|0.0017
71776630|NCT03633617|143052417|SUPERIORITY||Difference in proportion|27.6|||<|0.0001|TWO_SIDED|95.0|17.2|38.09|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||38.09|17.20|<0.0001
71834120|NCT02554786|143172205|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|95.0|0.094|0.184|||MMRM|||Day 364: 5 minutes||0.184|0.094|<0.001
71834121|NCT02554786|143172205|SUPERIORITY||LS Mean|0.249|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.205|0.294|||MMRM|||Day 364: 5 minutes||0.294|0.205|<0.001
71834122|NCT02554786|143172205|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0227||0.244|TWO_SIDED|95.0|-0.018|0.071|||MMRM|||Day 364: 5 minutes||0.071|-0.018|0.244
71834123|NCT02554786|143172205|SUPERIORITY||LS Mean|0.155|STANDARD_ERROR_OF_MEAN|0.0228|<|0.001|TWO_SIDED|95.0|0.11|0.2|||MMRM|||Day 364: 30 minutes||0.200|0.110|<0.001
71834124|NCT02554786|143172205|SUPERIORITY||LS Mean|0.264|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|95.0|0.219|0.308|||MMRM|||Day 364: 30 minutes||0.308|0.219|<0.001
71834125|NCT02554786|143172205|SUPERIORITY||LS Mean|0.032|STANDARD_ERROR_OF_MEAN|0.0226||0.162|TWO_SIDED|95.0|-0.013|0.076|||MMRM|||Day 364: 30 minutes||0.076|-0.013|0.162
71834126|NCT02554786|143172205|SUPERIORITY||LS Mean|0.163|STANDARD_ERROR_OF_MEAN|0.0234|<|0.001|TWO_SIDED|95.0|0.117|0.209|||MMRM|||Day 364: 1 hour||0.209|0.117|<0.001
71834127|NCT02554786|143172205|SUPERIORITY||LS Mean|0.262|STANDARD_ERROR_OF_MEAN|0.0232|<|0.001|TWO_SIDED|95.0|0.216|0.308|||MMRM|||Day 364: 1 hour||0.308|0.216|<0.001
71834128|NCT02554786|143172205|SUPERIORITY||LS Mean|0.031|STANDARD_ERROR_OF_MEAN|0.0231||0.182|TWO_SIDED|95.0|-0.014|0.076|||MMRM|||Day 364: 1 hour||0.076|-0.014|0.182
71834129|NCT02554786|143172206|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0237|<|0.001|TWO_SIDED|95.0|0.04|0.133|||MMRM|||Day 2||0.133|0.040|<0.001
71834130|NCT02554786|143172206|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0235|<|0.001|TWO_SIDED|95.0|0.093|0.185|||MMRM|||Day 2||0.185|0.093|<0.001
71834131|NCT02554786|143172206|SUPERIORITY||LS Mean|-0.002|STANDARD_ERROR_OF_MEAN|0.0237||0.927|TWO_SIDED|95.0|-0.049|0.044|||MMRM|||Day 2||0.044|-0.049|0.927
71834132|NCT02554786|143172206|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0246||0.044|TWO_SIDED|95.0|0.001|0.098|||MMRM|||Day 184||0.098|0.001|0.044
71834133|NCT02554786|143172206|SUPERIORITY||LS Mean|0.141|STANDARD_ERROR_OF_MEAN|0.0246|<|0.001|TWO_SIDED|95.0|0.093|0.19|||MMRM|||Day 184||0.190|0.093|<0.001
71834134|NCT02554786|143172206|SUPERIORITY||LS Mean|0.017|STANDARD_ERROR_OF_MEAN|0.0244||0.49|TWO_SIDED|95.0|-0.031|0.065|||MMRM|||Day 184||0.065|-0.031|0.490
71834135|NCT02554786|143172206|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0249||0.002|TWO_SIDED|95.0|0.027|0.125|||MMRM|||Day 365||0.125|0.027|0.002
71834136|NCT02554786|143172206|SUPERIORITY||LS Mean|0.146|STANDARD_ERROR_OF_MEAN|0.0248|<|0.001|TWO_SIDED|95.0|0.098|0.195|||MMRM|||Day 365||0.195|0.098|<0.001
71834137|NCT02554786|143172206|SUPERIORITY||LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0248||0.143|TWO_SIDED|95.0|-0.012|0.085|||MMRM|||Day 365||0.085|-0.012|0.143
71834138|NCT02554786|143172207|SUPERIORITY||LS Mean|0.189|STANDARD_ERROR_OF_MEAN|0.0253|<|0.001|TWO_SIDED|95.0|0.139|0.238|||MMRM|||Day 2||0.238|0.139|<0.001
71834139|NCT02554786|143172207|SUPERIORITY||LS Mean|0.21|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.161|0.259|||MMRM|||Day 2||0.259|0.161|<0.001
71834140|NCT02554786|143172207|SUPERIORITY||LS Mean|-0.018|STANDARD_ERROR_OF_MEAN|0.0252||0.475|TWO_SIDED|95.0|-0.067|0.031|||MMRM|||Day 2||0.031|-0.067|0.475
71834141|NCT02554786|143172207|SUPERIORITY||LS Mean|0.228|STANDARD_ERROR_OF_MEAN|0.0345|<|0.001|TWO_SIDED|95.0|0.161|0.296|||MMRM|||Day 184||0.296|0.161|<0.001
71834142|NCT02554786|143172207|SUPERIORITY||LS Mean|0.265|STANDARD_ERROR_OF_MEAN|0.0346|<|0.001|TWO_SIDED|95.0|0.197|0.333|||MMRM|||Day 184||0.333|0.197|<0.001
71834143|NCT02554786|143172207|SUPERIORITY||LS Mean|0.083|STANDARD_ERROR_OF_MEAN|0.0343||0.015|TWO_SIDED|95.0|0.016|0.151|||MMRM|||Day 184||0.151|0.016|0.015
71834144|NCT02554786|143172207|SUPERIORITY||LS Mean|0.215|STANDARD_ERROR_OF_MEAN|0.0358|<|0.001|TWO_SIDED|95.0|0.145|0.285|||MMRM|||Day 365||0.285|0.145|<0.001
71834145|NCT02554786|143172207|SUPERIORITY||LS Mean|0.246|STANDARD_ERROR_OF_MEAN|0.0357|<|0.001|TWO_SIDED|95.0|0.176|0.316|||MMRM|||Day 365||0.316|0.176|<0.001
71834146|NCT02554786|143172207|SUPERIORITY||LS Mean|0.053|STANDARD_ERROR_OF_MEAN|0.0356||0.139|TWO_SIDED|95.0|-0.017|0.122|||MMRM|||Day 365||0.122|-0.017|0.139
71834147|NCT02554786|143172208|SUPERIORITY||LS Mean|29.6|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|23.8|35.4|||Linear Mixed Model (LMM)|||Week 26: Mean morning PEF||35.4|23.8|<0.001
71834148|NCT02554786|143172208|SUPERIORITY||LS Mean|32.2|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|26.4|38.1|||LMM|||Week 26: Mean morning PEF||38.1|26.4|<0.001
71834149|NCT02554786|143172208|SUPERIORITY||LS Mean|13.3|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|7.5|19.1|||LMM|||Week 26: Mean morning PEF||19.1|7.5|<0.001
71834150|NCT02554786|143172208|SUPERIORITY||LS Mean|24.8|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|19.3|30.3|||LMM|||Week 26: Mean evening PEF||30.3|19.3|<0.001
71834151|NCT02554786|143172208|SUPERIORITY||LS Mean|30.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|24.8|35.9|||LMM|||Week 26: Mean evening PEF||35.9|24.8|<0.001
71834152|NCT02554786|143172208|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.83||0.002|TWO_SIDED|95.0|3.1|14.2|||LMM|||Week 26: Mean evening PEF||14.2|3.1|0.002
71834153|NCT02554786|143172208|SUPERIORITY||LS Mean|28.7|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|22.7|34.8|||LMM|||Week 52: Mean morning PEF||34.8|22.7|<0.001
71834154|NCT02554786|143172208|SUPERIORITY||LS Mean|30.2|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|24.2|36.3|||LMM|||Week 52: Mean morning PEF||36.3|24.2|<0.001
71834155|NCT02554786|143172208|SUPERIORITY||LS Mean|13.8|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|7.7|19.8|||LMM|||Week 52: Mean morning PEF||19.8|7.7|<0.001
71834156|NCT02554786|143172208|SUPERIORITY||LS Mean|23.7|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|18.0|29.5|||LMM|||Week 52: Mean evening PEF||29.5|18.0|<0.001
71834157|NCT02554786|143172208|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|23.3|34.8|||LMM|||Week 52: Mean evening PEF||34.8|23.3|<0.001
71834158|NCT02554786|143172208|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.95||0.002|TWO_SIDED|95.0|3.3|14.9|||LMM|||Week 52: Mean evening PEF||14.9|3.3|0.002
71741485|NCT01525615|142995237|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.234|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.133|0.336||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|LSMean=Least square mean.|||0.336|0.133|<0.0001
71741486|NCT01525615|142995237|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.207|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.105|0.309||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.309|0.105|<0.0001
71741487|NCT01525615|142995237|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.027|STANDARD_ERROR_OF_MEAN|0.05||0.5892|TWO_SIDED|95.0|-0.072|0.126||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.||||0.126|-0.072|0.5892
71741488|NCT01525615|142995238|SUPERIORITY_OR_OTHER||Treatment ratio|1.126|STANDARD_ERROR_OF_MEAN|0.059||0.0245|TWO_SIDED|95.0|1.015|1.248||ANCOVA model for log10 (endurance time \[s\]) with categorical effects of treatment and (log10-transformed) baseline as continuous covariate.|ANCOVA|This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo||1.248|1.015|0.0245
71741489|NCT01525615|142995238|SUPERIORITY_OR_OTHER||Treatment ratio|1.103|STANDARD_ERROR_OF_MEAN|0.058||0.0655|TWO_SIDED|95.0|0.994|1.223|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 2.5/5.0 and placebo||1.223|0.994|0.0655
71741490|NCT01525615|142995238|SUPERIORITY_OR_OTHER||Treatment ratio|1.021|STANDARD_ERROR_OF_MEAN|0.053||0.6912|TWO_SIDED|95.0|0.921|1.132|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0||1.132|0.921|0.6912
71741491|NCT01525615|142995239|SUPERIORITY_OR_OTHER||Treatment ratio|1.229|STANDARD_ERROR_OF_MEAN|0.068||0.0002|TWO_SIDED|95.0|1.103|1.37||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Hypothesis test is descriptive||1.370|1.103|0.0002
71741492|NCT01525615|142995239|SUPERIORITY_OR_OTHER||Treatment ratio|1.221|STANDARD_ERROR_OF_MEAN|0.068||0.0004|TWO_SIDED|95.0|1.095|1.362||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. Hypothesis test is descriptive.||1.362|1.095|0.0004
71741493|NCT01525615|142995239|SUPERIORITY_OR_OTHER||Treatment ratio|1.006|STANDARD_ERROR_OF_MEAN|0.055||0.9062|TWO_SIDED|95.0|0.905|1.12||MMRM model for log10 (endurance time \[s\]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time \[s\]), log10 (baseline endurance time \[s\]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. Hypothesis test is descriptive.||1.12|0.905|0.9062
71741494|NCT01525615|142995240|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.165|STANDARD_ERROR_OF_MEAN|0.058||0.0049|TWO_SIDED|95.0|0.051|0.279||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.279|0.051|0.0049
71741495|NCT01525615|142995240|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.202|STANDARD_ERROR_OF_MEAN|0.058||0.0006|TWO_SIDED|95.0|0.088|0.316||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.316|0.088|0.0006
71741496|NCT01525615|142995240|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.037|STANDARD_ERROR_OF_MEAN|0.058||0.5162|TWO_SIDED|95.0|-0.151|0.076||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.076|-0.151|0.5162
71741497|NCT01525615|142995241|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.225|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.124|0.326||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.326|0.124|<0.0001
71741498|NCT01525615|142995241|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.187|STANDARD_ERROR_OF_MEAN|0.052||0.0003|TWO_SIDED|95.0|0.086|0.288||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.288|0.086|0.0003
71741499|NCT01525615|142995241|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.038|STANDARD_ERROR_OF_MEAN|0.05||0.4541|TWO_SIDED|95.0|-0.061|0.137||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.137|-0.061|0.4541
71741500|NCT01525615|142995242|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0468|TWO_SIDED|95.0|-0.004|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.004|0.0468
71776631|NCT03633617|143052417|SUPERIORITY||Difference in proportion|28.9|||<|0.0001|TWO_SIDED|95.0|18.36|39.46|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||39.46|18.36|<0.0001
71664089|NCT03301623|142841713|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.719|TWO_SIDED|95.0|-2.73|1.88|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in improving physical function over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the participant level."||1.88|-2.73|.719
71664090|NCT03301623|142841714|SUPERIORITY||Odds Ratio (OR)|1.63||||0.01|TWO_SIDED|95.0|1.13|2.36|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|"Question: Which communication strategy used during the clinical encounter is more effective in reducing opioid prescriptions of more than 90 morphine milligrams equivalent (MME) over time for patients with chronic pain who were taking opioids at baseline?~Regression model includes a fixed effect for time and an interaction effect between pre/post intervention and intervention arm dummy variables. Analysis is clustered at the PCP level."||2.36|1.13|.010
71664091|NCT03301623|142841715|SUPERIORITY||Odds Ratio (OR)|0.76||||0.51|TWO_SIDED|95.0|0.34|1.71|||Mixed Models Analysis||The interaction term describes the effect of PEAT in the post period.|Question: Which communication strategy used during the clinical encounter is more effective in reducing co-prescription of opioids and benzodiazepines over time for patients with chronic pain who were taking opioids at baseline?||1.71|.34|.510
71664092|NCT03301623|142841716|SUPERIORITY||Odds Ratio (OR)|1.34||||0.26|TWO_SIDED|95.0|0.76|2.34|||Regression, Logistic|We employed robust standard errors clustered at the participant level. Time was controlled for using a fixed effect.|The interaction term describes the effect of PEAT in the post period.|PHQ-9 was categorized by assigning scores of 0, 1, 2, and 3 to the response categories (not at all: several days, more than half the days, nearly every day, respectively) and then summing. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The analysis was conducted as a multilevel ordered logistic regression.||2.34|.76|.260
71664093|NCT01595386|142841718|NON_INFERIORITY_OR_EQUIVALENCE|Study sample size was powered to detect a 60% difference in LCOS between groups at α 0.05 and β 0.70, assuming the prevalence of LCOS after neonatal bypass of 65% (based on retrospective data of patients who died, required rescue steroids, ECMO, or epinephrine \> 0.1 μg/kg/min).||||||0.049|TWO_SIDED|||||A p-value of \<0.05 represents the threshold for statistical significance.|t-test, 2 sided|||||||0.049
71741501|NCT01525615|142995242|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.018|TWO_SIDED|95.0|-0.005|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||-0.000|-0.005|0.0180
71834159|NCT02554786|143172209|SUPERIORITY||Odds Ratio (OR)|1.31||||0.094|TWO_SIDED|95.0|0.95|1.81|||Logistic regression model|||Day 183||1.81|0.95|0.094
71664094|NCT01595386|142841719|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.44|TWO_SIDED|95.0|||||Chi-squared|||||||0.44
71664095|NCT01595386|142841720|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.62|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.62
71664096|NCT01595386|142841721|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71664097|NCT01595386|142841721|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||interleukin-6 at 12, 24, and 48 hour. A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
71664098|NCT01595386|142841721|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.01|TWO_SIDED|95.0||||TNF-alpha at 12, 24, and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.01
71664099|NCT01595386|142841721|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin1-beta at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
71664100|NCT01595386|142841721|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.05|TWO_SIDED|95.0||||Interleukin-8 at 24 and 48 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||<0.05
71664101|NCT01595386|142841721|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.03|TWO_SIDED|95.0||||IL-10 at 4 hours.A p-value of \<0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.03
71664102|NCT01595386|142841722|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71664103|NCT01595386|142841723|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
71664104|NCT01595386|142841724|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71664105|NCT01595386|142841725|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.7|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7
71741502|NCT01525615|142995242|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6856|TWO_SIDED|95.0|-0.002|0.002||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive||||0.002|-0.002|0.6856
71834160|NCT02554786|143172209|SUPERIORITY||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.26|2.37|||Logistic regression model|||Day 183||2.37|1.26|<0.001
71834161|NCT02554786|143172209|SUPERIORITY||Odds Ratio (OR)|1.06||||0.746|TWO_SIDED|95.0|0.76|1.46|||Logistic regression model|||Day 183||1.46|0.76|0.746
71834162|NCT02554786|143172209|SUPERIORITY||Odds Ratio (OR)|1.34||||0.088|TWO_SIDED|95.0|0.96|1.87|||Logistic regression model|||Day 364||1.87|0.96|0.088
71834163|NCT02554786|143172209|SUPERIORITY||Odds Ratio (OR)|2.24|||<|0.001|TWO_SIDED|95.0|1.58|3.17|||Logistic regression model|||Day 364||3.17|1.58|<0.001
71664106|NCT01595386|142841726|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
71741503|NCT01525615|142995243|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0081|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0081
71741504|NCT01525615|142995243|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0099|TWO_SIDED|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.001|-0.005|0.0099
71741505|NCT01525615|142995243|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9626|TWO_SIDED|95.0|-0.002|0.002||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.002|-0.002|0.9626
71741506|NCT01525615|142995244|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0598|TWO_SIDED|95.0|-0.004|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.000|-0.004|0.0598
71741507|NCT01525615|142995244|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.003|STANDARD_ERROR_OF_MEAN|0.001||0.0218|TWO_SIDED|95.0|-0.005|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||-0.000|-0.005|0.0218
71741508|NCT01525615|142995244|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.6549|TWO_SIDED|95.0|-0.002|0.003||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.003|-0.002|0.6549
71741509|NCT01525615|142995245|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.17|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.116|0.224||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.224|0.116|<0.0001
71741510|NCT01525615|142995245|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.184|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.129|0.239||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.239|0.129|<0.0001
71741511|NCT01525615|142995245|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6105|TWO_SIDED|95.0|-0.067|0.04||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.040|-0.067|0.6105
71741512|NCT01525615|142995246|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.192|0.3||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.300|0.192|<0.0001
71741513|NCT01525615|142995246|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.273|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.218|0.328||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.328|0.218|<0.0001
71741514|NCT01525615|142995246|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3236|TWO_SIDED|95.0|-0.08|0.027||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.027|-0.080|0.3236
71741515|NCT01525615|142995247|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.196|0.305||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.305|0.196|<0.0001
71741516|NCT01525615|142995247|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|0.257|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.202|0.312||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.312|0.202|<0.0001
71741517|NCT01525615|142995247|SUPERIORITY_OR_OTHER||LSMean Difference-Final Values|-0.006|STANDARD_ERROR_OF_MEAN|0.027||0.8156|TWO_SIDED|95.0|-0.06|0.047||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive||||0.047|-0.060|0.8156
71664107|NCT01595386|142841727|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.||||||0.23|TWO_SIDED|95.0|||||Fisher Exact|||||||0.23
71741518|NCT04775953|142995303|SUPERIORITY|For participants with the same DOOR, quality-of-life (QoL) was used as a tiebreaker and was calculated as change from baseline QoL to Day 70 QoL score, as assessed by questions from the PROMIS physical function item bank (PROMIS Item Bank v2.0, short form 6b) on the Antibacterial Resistance Leadership Group (ARLG) Bloodstream Infection QoL Measure. Superiority of dalbavancin is concluded if the lower bound of the 95% confidence interval for the DOOR probability is greater than 50%.|Pr(Better DOOR in dalbavancin arm)|47.7|||||TWO_SIDED|95.0|39.84|55.68|||||The DOOR probability is calculated using the Wilcoxon-Mann-Whitney statistic corrected for ties.|Null Hypothesis: Probability that a participant in the dalbavancin arm has a better DOOR than a participant in the standard of care arm plus one-half the probability of equal DOOR is 50% (i.e., no difference in DOOR).||55.68|39.84|
71664108|NCT01595386|142841728|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were not performed on this statistical calculation.|||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71664109|NCT01595386|142841728|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic|||||<|0.001|TWO_SIDED|95.0||||post-operative cortisol.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||<0.001
71741519|NCT04775953|142995304|NON_INFERIORITY|The non-inferiority margin is -20%. Non-inferiority of dalbavancin is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical efficacy is greater than -20%.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-12.0|14.0|||||Difference in proportions of clinical efficacy for dalbavancin compared to standard of care and 95% confidence interval obtained from a linear regression model.|Null Hypothesis: The proportion of clinical efficacy in the dalbavancin arm minus the proportion of clinical efficacy in the standard of care arm is -20%.||14|-12|
71741520|NCT03777059|142995312|SUPERIORITY||Least Squares Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.291|<|0.0001|TWO_SIDED|95.0|-1.78|-0.64||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.64|-1.78|<.0001
71741521|NCT03777059|142995312|SUPERIORITY||Least Squares Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.287|<|0.0001|TWO_SIDED|95.0|-1.94|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.94|<.0001
71741522|NCT03777059|142995312|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.288|<|0.0001|TWO_SIDED|95.0|-2.28|-1.15||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.15|-2.28|<.0001
71741523|NCT03777059|142995313|SUPERIORITY||Least Squares Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-2.03|-0.81||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.81|-2.03|<.0001
71741524|NCT03777059|142995313|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.92|-2.13|<.0001
71741525|NCT03777059|142995313|SUPERIORITY||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.309|<|0.0001|TWO_SIDED|95.0|-2.32|-1.1||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.10|-2.32|<.0001
71741526|NCT03777059|142995314|SUPERIORITY||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-1.81|-0.82||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.82|-1.81|<.0001
71741527|NCT03777059|142995314|SUPERIORITY||Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.251|<|0.0001|TWO_SIDED|95.0|-1.82|-0.83||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.83|-1.82|<.0001
71741528|NCT03777059|142995314|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.252|<|0.0001|TWO_SIDED|95.0|-2.0|-1.01||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.01|-2.00|<.0001
71776632|NCT03633617|143052418|SUPERIORITY||LS Mean Difference|-0.368||||0.0077|TWO_SIDED|95.0|-0.6388|-0.0975|||ANCOVA||Dupilumab group vs Placebo|||-0.0975|-0.6388|0.0077
71776633|NCT03633617|143052418|SUPERIORITY||LS Mean Difference|-0.015||||0.8586|TWO_SIDED|95.0|-0.1782|0.1485|||ANCOVA||Dupilumab group vs. Placebo|||0.1485|-0.1782|0.8586
71776634|NCT03633617|143052418|SUPERIORITY||LS Mean Difference|-0.309||||0.0002|TWO_SIDED|95.0|-0.4703|-0.1471|||ANCOVA||Dupilumab group vs. Placebo|||-0.1471|-0.4703|0.0002
71776635|NCT03633617|143052419|SUPERIORITY||LS Mean Difference|-2.0||||0.0467|TWO_SIDED|95.0|-3.87|-0.03|||ANCOVA||Dupilumab group vs. Placebo|||-0.03|-3.87|0.0467
71776636|NCT03633617|143052419|SUPERIORITY||LS Mean Difference|-0.5||||0.5469||95.0|-2.03|1.08|||ANCOVA||Dupilumab group vs. Placebo|||1.08|-2.03|0.5469
71776637|NCT03633617|143052419|SUPERIORITY||LS Mean Difference|-1.5||||0.0718|TWO_SIDED|95.0|-3.0|0.13|||ANCOVA||Dupilumab group vs. Placebo|||0.13|-3.0|0.0718
71776638|NCT03633617|143052420|SUPERIORITY||LS Mean Difference|-1.7||||0.0051|TWO_SIDED|95.0|-2.93|-0.52|||ANCOVA||Dupilumab group vs. Placebo|||-0.52|-2.93|0.0051
71776639|NCT03633617|143052420|SUPERIORITY||LS Mean Difference|-0.5||||0.3152|TWO_SIDED|95.0|-1.38|0.44|||ANCOVA||Dupilumab group vs. Placebo|||0.44|-1.38|0.3152
71776640|NCT03633617|143052420|SUPERIORITY||LS Mean Difference|-1.4||||0.0037|TWO_SIDED|95.0|-2.3|0.45|||ANCOVA||Dupilumab group vs. Placebo|||0.45|-2.30|0.0037
71776641|NCT03633617|143052421|SUPERIORITY||Difference in proportion|-12.7||||0.017|TWO_SIDED|95.0|-23.21|-2.26|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||-2.26|-23.21|0.0170
71776642|NCT03633617|143052421|SUPERIORITY||Difference in proportion|-1.3||||0.5493|TWO_SIDED|95.0|-5.51|2.93|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||2.93|-5.51|0.5493
71776643|NCT03633617|143052421|SUPERIORITY||Difference in proportion|0.0||||0.9887|TWO_SIDED|95.0|-4.9|5.02|||Cochran-Mantel-Haenszel||Difference is Dupilumab minus Placebo|||5.02|-4.9|0.9887
71776644|NCT01890746|143052450|OTHER|Bioequivalence|Ratio of geometric means (%)|114.9|||||TWO_SIDED|90.0|99.5|132.7||||||||132.7|99.5|
71776645|NCT01890746|143052451|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|97.1|114.0||||||||114.0|97.1|
71776646|NCT01890746|143052452|OTHER|Bioequivalence|Ratio of geometric means (%)|92.0|||||TWO_SIDED|90.0|76.8|110.2||||||||110.2|76.8|
71776647|NCT01890746|143052453|OTHER|Bioequivalence|Ratio of geometric means (%)|101.8|||||TWO_SIDED|90.0|92.9|111.7||||||||111.7|92.9|
71776648|NCT01890746|143052454|OTHER|Bioequivalence|Ratio of geometric means (%)|121.0|||||TWO_SIDED|90.0|102.5|142.8||||||||142.8|102.5|
71741529|NCT03777059|142995315|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.0001|TWO_SIDED|95.0|2.05|4.56||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||4.56|2.05|<.0001
71741530|NCT03777059|142995315|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.37|5.26||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.26|2.37|<.0001
71741531|NCT03777059|142995315|SUPERIORITY||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.56|5.71||Odds ratio and p-value was based on logistic regression with treatment group, Baseline value, and prior exposure to a migraine prevention medications with proven efficacy as explanatory variables.|Regression, Logistic|||||5.71|2.56|<.0001
71741532|NCT03777059|142995316|SUPERIORITY||Least Squares Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|95.0|5.45|14.36||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.36|5.45|<.0001
71741533|NCT03777059|142995316|SUPERIORITY||Least Squares Mean Difference|10.08|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|5.71|14.46||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||14.46|5.71|<.0001
71741534|NCT03777059|142995316|SUPERIORITY||Least Squares Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|2.231|<|0.0001|TWO_SIDED|95.0|6.42|15.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||15.18|6.42|<.0001
71741535|NCT03777059|142995317|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.693||0.0856|TWO_SIDED|95.0|-2.56|0.17||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.17|-2.56|0.0856
71741536|NCT03777059|142995317|SUPERIORITY||Least Squares Mean Difference|-2.54|STANDARD_ERROR_OF_MEAN|0.694||0.0003|TWO_SIDED|95.0|-3.91|-1.18||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.18|-3.91|0.0003
71741537|NCT03777059|142995317|SUPERIORITY||Least Squares Mean Difference|-3.32|STANDARD_ERROR_OF_MEAN|0.694|<|0.0001|TWO_SIDED|95.0|-4.68|-1.96||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.96|-4.68|<.0001
71741538|NCT03777059|142995318|SUPERIORITY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.605||0.0743|TWO_SIDED|95.0|-2.27|0.11||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||0.11|-2.27|0.0743
71741539|NCT03777059|142995318|SUPERIORITY||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.606||0.0011|TWO_SIDED|95.0|-3.18|-0.8||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-0.80|-3.18|0.0011
71741540|NCT03777059|142995318|SUPERIORITY||Least Squares Mean Difference|-2.46|STANDARD_ERROR_OF_MEAN|0.605|<|0.0001|TWO_SIDED|95.0|-3.65|-1.28||MMRM model included Baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and Baseline-by-visit as interaction terms, with an unstructured covariance matrix.|Mixed-effects Model for Repeated Measure|||||-1.28|-3.65|<.0001
71741541|NCT02813889|142995331|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0054|TWO_SIDED|95.0|-0.0261|-0.0031||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0031|-0.0261|0.0054
71741542|NCT02813889|142995332|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.02||||0.0005|TWO_SIDED|95.0|-0.0331|-0.007||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0070|-0.0331|0.0005
71741543|NCT02813889|142995333|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0146||||0.0088|TWO_SIDED|95.0|-0.0267|-0.0026||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||-0.0026|-0.0267|0.0088
71741544|NCT02813889|142995334|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.0059||||0.7624|TWO_SIDED|95.0|-0.018|0.0062||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length (Full-Term) - Path Length (Pre-Term)|||0.0062|-0.0180|0.7624
71741545|NCT02813889|142995335|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0129||||0.0326|TWO_SIDED|95.0|0.0007|0.0251||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0251|0.0007|0.0326
71776649|NCT01890746|143052455|OTHER|Bioequivalence|Ratio of geometric means (%)|106.5|||||TWO_SIDED|90.0|95.0|119.4||||||||119.4|95.0|
71776650|NCT01890746|143052456|OTHER|Bioequivalence|Ratio of geometric means (%)|91.7|||||TWO_SIDED|90.0|76.5|110.0||||||||110.0|76.5|
71776651|NCT01890746|143052457|OTHER|Bioequivalence|Ratio of geometric means (%)|101.4|||||TWO_SIDED|90.0|92.4|111.2||||||||111.2|92.4|
71776652|NCT01890746|143052458|OTHER|Bioequivalence|Ratio of geometric means (%)|120.0|||||TWO_SIDED|90.0|100.7|142.6||||||||142.6|100.7|
71776653|NCT01890746|143052459|OTHER|Bioequivalence|Ratio of geometric means (%)|105.2|||||TWO_SIDED|90.0|93.6|118.3||||||||118.3|93.6|
71776654|NCT01890746|143052460|OTHER|Bioequivalence|Ratio of geometric means (%)|80.4|||||TWO_SIDED|90.0|57.2|113.0||||||||113.0|57.2|
71776655|NCT01890746|143052461|OTHER|Bioequivalence|Ratio of geometric means (%)|106.3|||||TWO_SIDED|90.0|87.6|129.0||||||||129.0|87.6|
71776656|NCT01890746|143052462|OTHER|Bioequivalence|Ratio of geometric means (%)|127.1|||||TWO_SIDED|90.0|84.2|191.9||||||||191.9|84.2|
71776657|NCT01890746|143052463|OTHER|Bioequivalence|Ratio of geometric means (%)|110.5|||||TWO_SIDED|90.0|83.9|145.7||||||||145.7|83.9|
71776658|NCT01890746|143052464|OTHER|Bioequivalence|Ratio of geometric means (%)|286.4|||||TWO_SIDED|90.0|90.1|910.7||||||||910.7|90.1|
71776659|NCT01890746|143052465|OTHER|Bioequivalence|Ratio of geometric means (%)|202.3|||||TWO_SIDED|90.0|131.3|311.8||||||||311.8|131.3|
71776660|NCT01890746|143052467|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.7461|TWO_SIDED|95.0|0.28|2.48|||Log Rank|||||2.48|0.28|0.7461
71776661|NCT01890746|143052468|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6175|TWO_SIDED|95.0|0.74|1.63|||Log Rank|||||1.63|0.74|0.6175
71776662|NCT01890746|143052469|SUPERIORITY||Odds Ratio (OR)|0.5281||||0.3224|TWO_SIDED|95.0|0.1084|2.2086|||Cochran-Mantel-Haenszel|||||2.2086|0.1084|0.3224
71776663|NCT01890746|143052471|SUPERIORITY|||||||0.6942|||||||Wilcoxon rank-sum test|||||||0.6942
71776664|NCT01890746|143052472|SUPERIORITY||Odds Ratio (OR)|1.1151||||0.7397|TWO_SIDED|95.0|0.5585|2.229|||Cochran-Mantel-Haenszel|||||2.2290|0.5585|0.7397
71776665|NCT01890746|143052473|SUPERIORITY||Hazard Ratio (HR)|2.46||||0.0781|TWO_SIDED|95.0|0.95|6.38|||Log Rank|||||6.38|0.95|0.0781
71776666|NCT01890746|143052477|SUPERIORITY||Odds Ratio (OR)|0.8749||||0.7122|TWO_SIDED|95.0|0.4023|1.8943|||Cochran-Mantel-Haenszel|||||1.8943|0.4023|0.7122
71776667|NCT01890746|143052478|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.0688|TWO_SIDED|95.0|0.96|2.47|||Log Rank|||||2.47|0.96|0.0688
71776668|NCT02642029|143052480|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexiTBS interact|-0.099|STANDARD_ERROR_OF_MEAN|0.051||0.51|TWO_SIDED|95.0|-0.1989|0.0002||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the iTBS (vs. sham) x time interaction.||.0002|-.1989|0.51
71776669|NCT02642029|143052480|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on IDT accuracy.|Beta coefficient for timexcTBS interact|-0.0757|STANDARD_ERROR_OF_MEAN|0.052||0.143|TWO_SIDED|95.0|-0.177|0.0256||Significance threshold of p \< 0.05, two-sided.|Mixed Models Analysis|Model included time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS).||Conducted a mixed effects analysis, with IDT accuracy as the dependent variable and time (pre, post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) as the independent variables. P-value here is for the cTBS (vs. sham) x time interaction.||.0256|-.1770|0.143
71776670|NCT02642029|143052481|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-0.0446||||0.626|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||.626
71776671|NCT02642029|143052481|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-0.0903||||0.322|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with binomial (logit) distribution.~N-back accuracy was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.322
71776672|NCT02642029|143052482|EQUIVALENCE|Tested the null hypothesis of no difference between iTBS and sham TBS on N-back accuracy.|Beta coefficient for timexiTBS interact|-9.797||||0.1118|TWO_SIDED|||||Significance threshold of p \< 0.05, two-sided|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the iTBS (vs. sham) x time interaction."||||0.1118
71776673|NCT02642029|143052482|EQUIVALENCE|Tested the null hypothesis of no difference between cTBS and sham TBS on N-back accuracy.|Beta coefficient for timexcTBS interact|-47.764||||9e-08|TWO_SIDED|||||Significance threshold was p \< 0.05, two-sided.|Mixed Models Analysis|||"Conducted a generalized linear mixed model fit by maximum likelihood (Laplace Approximation) \['glmerMod' in R\] with gamma distribution.~N-back reaction time (RT) was the dependent variable. Time (pre vs. post), condition (iTBS vs. sham, cTBS vs. sham), and the interaction of time x condition (time x iTBS, time x cTBS) were the independent variables. P-value here is for the cTBS (vs. sham) x time interaction."||||0.00000009
71776674|NCT02642029|143052483|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.91||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.910
71834164|NCT02554786|143172209|SUPERIORITY||Odds Ratio (OR)|1.05||||0.771|TWO_SIDED|95.0|0.75|1.49|||Logistic regression model|||Day 364||1.49|0.75|0.771
71741546|NCT02813889|142995336|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0309|||<|0.0001|TWO_SIDED|95.0|0.0138|0.048||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0480|0.0138|<0.0001
71741547|NCT02813889|142995337|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.017||||0.0025|TWO_SIDED|95.0|0.0045|0.0295||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0295|0.0045|0.0025
71741548|NCT02813889|142995338|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.0066||||0.6782|TWO_SIDED|95.0|-0.0059|0.0191||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = Path Length per second (Typical) - Path Length per second (Atypical)|||0.0191|-0.0059|0.6782
71741549|NCT02813889|142995339|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.064||||0.0479|TWO_SIDED|95.0|0.006|2.122||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.122|0.006|0.0479
71741550|NCT02813889|142995340|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.278||||0.9947|TWO_SIDED|95.0|-0.921|1.477||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.477|-0.921|0.9947
71741551|NCT02813889|142995341|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.835||||0.2614|TWO_SIDED|95.0|-0.274|1.945||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||1.945|-0.274|0.2614
71741552|NCT02813889|142995342|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|1.176||||0.0314|TWO_SIDED|95.0|0.066|2.286||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Full-Term) - StdDevY (Pre-Term)|||2.286|0.066|0.0314
71741553|NCT02813889|142995343|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.074||||0.0958|TWO_SIDED|95.0|-2.255|0.1059||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1059|-2.255|0.0958
71741554|NCT02813889|142995344|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|0.5248||||0.966|TWO_SIDED|95.0|-1.1243|2.1739||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||2.1739|-1.1243|0.9660
71741555|NCT02813889|142995345|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-0.4198||||0.9462|TWO_SIDED|95.0|-1.6278|0.7882||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.7882|-1.6278|0.9462
71741556|NCT02813889|142995346|SUPERIORITY|Two-Factor ANOVA in repeated measures|Mean Difference (Net)|-1.0705||||0.1129|TWO_SIDED|95.0|-2.2785|0.1375||The threshold for statistical significance was p = 0.05.|ANOVA|p Values were adjusted for multiple comparisons using Tukey-Kramer tests.|Difference = StdDevY (Typical) - StdDevY (Atypical)|||0.1375|-2.2785|0.1129
71741557|NCT02451943|142995375|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.6945|TWO_SIDED|95.0|0.841|1.303|||Log Rank|Stratified||||1.303|0.841|0.6945
71741558|NCT02451943|142995376|SUPERIORITY||Hazard Ratio (HR)|0.951||||0.7618|TWO_SIDED|95.0|0.69|1.312|||Log Rank|Stratified||||1.312|0.690|0.7618
71741559|NCT02451943|142995377|SUPERIORITY||Hazard Ratio (HR)|1.231||||0.0422|TWO_SIDED|95.0|1.009|1.502|||Log Rank|Stratified||||1.502|1.009|0.0422
71741560|NCT02451943|142995383|SUPERIORITY||Hazard Ratio (HR)|0.616||||0.0934|TWO_SIDED|95.0|0.347|1.093|||Log Rank|Stratified||||1.093|0.347|0.0934
71741561|NCT02451943|142995384|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.3347|TWO_SIDED|95.0|0.892|1.413|||Log Rank|Stratified||||1.413|0.892|0.3347
71741562|NCT01101035|142995391|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.359 (75% interim) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|0.99|||||ONE_SIDED|97.0||1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23||
71741563|NCT01101035|142995392|OTHER||Cox Proportional Hazard|1.09|||||TWO_SIDED|95.0|0.92|1.28|||||Time from randomization to the first occurrence of any APTC event was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function status as a stratification factor.|||1.28|0.92|
71741564|NCT01101035|142995393|OTHER||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.73|||||Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.73|1.03|
71741565|NCT01101035|142995394|OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.21|0.72|
71741566|NCT01101035|142995395|OTHER||Cox Proportional Hazard|1.01|||||TWO_SIDED|95.0|0.73|1.41|||||Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.41|0.73|
71741567|NCT01101035|142995396|OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.59|1.26|||||Time from randomization to the first occurrence of unstable angina with urgent coronary revascularization was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.|||1.26|0.59|
71664110|NCT01595386|142841728|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.004|TWO_SIDED|95.0||||Adrenal Insufficiency after bypass.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.004
71664111|NCT01595386|142841728|NON_INFERIORITY_OR_EQUIVALENCE|There was not a power calculation for this statistic||||||0.02|TWO_SIDED|95.0||||Development of Low cardiac output syndrome in subjects with Adrenal Insufficiency.A p-value of \<0.05 is the threshold for statistical significance.|Fisher Exact|||||||0.02
71776675|NCT02642029|143052483|OTHER|Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|beta coefficient for depressed mood|0.00071||||0.243|TWO_SIDED|95.0|-0.00048|0.0019|||Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, depressed mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00190|-0.00048|0.243
71776676|NCT02642029|143052484|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.83||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.830
71776677|NCT02642029|143052484|OTHER||beta coefficient for anxiety|-0.00063||||0.284|TWO_SIDED|95.0|-0.00179|0.00052||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, anxiety). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00052|-0.00179|0.284
71776678|NCT02642029|143052485|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.755||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||0.755
71776679|NCT02642029|143052485|OTHER||beta coefficient for elated mood|-0.0007||||0.317|TWO_SIDED|95.0|-0.00208|0.00067||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, elated mood). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00067|-0.00208|0.317
71776680|NCT02642029|143052486|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.035||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.035
71776681|NCT02642029|143052486|OTHER||beta coefficient for auditory hallucinat|0.00195||||0.028|TWO_SIDED|95.0|0.00021|0.00369||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, auditory hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00369|0.00021|0.028
71776682|NCT02642029|143052487|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.748||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.748
71776683|NCT02642029|143052487|OTHER||beta coefficient for visual hallucinatio|-0.00039||||0.685|TWO_SIDED|95.0|-0.0023|0.00151||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, visual hallucinations). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00151|-0.00230|0.685
71776684|NCT02642029|143052488|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.02||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.020
71776685|NCT02642029|143052488|OTHER||beta coefficient for paranoid ideation|0.0004||||0.597|TWO_SIDED|95.0|-0.00108|0.00188||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, paranoid ideation). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00188|-0.00108|0.597
71664112|NCT04400682|142841738|EQUIVALENCE|0.80-1.25 margins for equivalence|Mean ratio|1.015||||0|TWO_SIDED|90.0|0.9897|1.041|||ANOVA||||Ln(AUClast) : 0.989- 1.0410|1.0410|0.9897|0.0000
71664113|NCT04400682|142841739|EQUIVALENCE|0.80 - 1.25 equivalence margin is required.|Mean ratio|1.0361||||0.0033|TWO_SIDED|90.0|0.9294|1.1551|||ANOVA||||Ln(Cmax) : 0.9294 - 1.1551|1.1551|0.9294|0.0033
71741568|NCT01101035|142995397|NON_INFERIORITY|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.014 (final analysis) based on the Lan-DeMets-O'Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|1.03|||||TWO_SIDED|97.0|0.87|1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.||1.23|0.87|
71776686|NCT02642029|143052489|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.237||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.237
71741569|NCT00555880|142995400|SUPERIORITY_OR_OTHER_LEGACY||Sign Statistic|3.0||||0.146|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.1460
71741570|NCT00555880|142995401|SUPERIORITY_OR_OTHER_LEGACY||Sign statistic|2.5||||0.2266|TWO_SIDED||||||Sign test||Sign test was performed per analysis plan.|||||0.2266
71741571|NCT00555880|142995402|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|97.9||||0.0418|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period and treatment as fixed effects, and subject within sequence as a random effect|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|Analysis of treatment difference||||0.0418
71741572|NCT00555880|142995403|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|91.1||||0.1928|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a one-way ANOVA model|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|||||0.1928
71741573|NCT00555880|142995404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9479|TWO_SIDED|||||The P-value is from a 2-sample t-test for difference in mean|t-test, 2 sided|||||||0.9479
71741574|NCT00555880|142995405|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-5.7||||0.059|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment||||0.0590
71741575|NCT00555880|142995406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Dizziness, Lightheadedness, and Feeling Faint-Analysis of treatment||||0.0633
71776687|NCT02642029|143052489|OTHER||beta coefficient for ideas/del of refere|-0.00142||||0.178|TWO_SIDED|95.0|-0.0035|0.00065||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, ideas/delusions of reference). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00065|-0.00350|0.178
71890867|NCT03093402|143303444|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.982|TWO_SIDED|95.0|-6.22|4.5||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|Each active JBT-101 cohort is compared to placebo.||4.50|-6.22|0.982
71741576|NCT00555880|142995406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Problems with Vision-Analysis of treatment||||0.0191
71776688|NCT02642029|143052490|EQUIVALENCE|Tested the null hypothesis that there is no effect of condition (iTBS, cTBS, sham) on pre-post change in VAS scores.||||||0.33||||||Given the exploratory nature of this pilot study, we set the significance threshold at p \< 0.05, two-sided, without correcting for eight comparisons.|Friedman test|Non-parametric repeated measures ANOVA.||||||.330
71741577|NCT00555880|142995406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0727|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Weakness-Analysis of treatment||||0.0727
71741578|NCT00555880|142995406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Fatigue-Analysis of treatment||||0.2820
71741579|NCT00555880|142995406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Trouble Concentrating-Analysis of treatment||||0.0880
71741580|NCT00555880|142995406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6439|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Head/Neck Discomfort-Analysis of treatment||||0.6439
71741581|NCT00555880|142995409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0378|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Final systolic pressure-Analysis of treatment||||0.0378
71741582|NCT00555880|142995409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED||||||ANOVA|||Final diastolic pressure-Analysis of treatment||||0.0108
71664114|NCT04400682|142841740|EQUIVALENCE|0.80 - 1.25 equivalence margin is not required.|Mean ratio|1.0108||||0|TWO_SIDED|90.0|0.9856|1.0366|||ANOVA||||Ln(Cmax) : 0.9856 - 1.0366|1.0366|0.9856|0.0000
71664115|NCT02293863|142841744|OTHER||Hazard Ratio (HR)|1.08||||0.605|TWO_SIDED|80.0|0.83|1.4|||Wilcoxon (Mann-Whitney)|||||1.40|0.83|0.6050
71664116|NCT02293863|142841744|OTHER||Hazard Ratio (HR)|1.13||||0.2028|TWO_SIDED|80.0|0.85|1.51|||Wilcoxon (Mann-Whitney)|||||1.51|0.85|0.2028
71664117|NCT02293863|142841746|OTHER||Difference in event rates|10.19||||0.1905|TWO_SIDED|80.0|-0.15|20.52|||Cochran-Mantel-Haenszel|||||20.52|-0.15|0.1905
71776689|NCT02642029|143052490|OTHER||beta coefficient for delusions of contro|-0.00038||||0.777|TWO_SIDED|95.0|-0.00305|0.00228||Given the exploratory nature of this pilot study, we set the significance threshold at p \<0.05, two-sided, without correcting for eight comparisons.|Mixed Models Analysis|||We explored the association between interval discrimination task (IDT) performance (accuracy) and each symptom self-rating (here, delusions of control). We conducted a mixed effects regression analysis to test the null hypothesis of no association. Model included time (pre, post) and condition (iTBS vs. sham, cTBS vs. sham) in addition to symptom rating as independent variables, and IDT performance accuracy as the dependent variable.||0.00228|-0.00305|0.777
71776690|NCT01480089|143052511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.308|STANDARD_ERROR_OF_MEAN|0.777||0.098|TWO_SIDED|95.0|-2.83|0.214|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.214|-2.830|.098
71776691|NCT01480089|143052512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.53||0.9|TWO_SIDED|95.0|-1.103|0.973|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).||0.973|-1.103|.90
71776692|NCT00631696|143052513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A non-inferiority margin of 20% was used to test the hypothesis. The null hypothesis is that the difference (PGB - PBO) in the proportion of participants with ≥50% reduction in sperm concentration is ≥20% and the alternative hypothesis is that the difference in proportion of participant with ≥50% reduction in sperm concentration is \<20%.|percentage difference|6.0|||||TWO_SIDED|95.0|-2.29|14.3|||Confidence Interval Approach||The confidence interval was based on asymptotic normal distribution.|Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not \>20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide \>90% power to show NI of PGB to PBO.||14.30|-2.29|
71776693|NCT00631696|143052514|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12||||0.3462|TWO_SIDED|95.0|-0.385|0.136||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.136|-0.385|0.3462
71776694|NCT00631696|143052515|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13||||0.3652|TWO_SIDED|95.0|-0.42|0.156||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.156|-0.420|0.3652
71776695|NCT00631696|143052516|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.1204|TWO_SIDED|95.0|-0.464|0.054||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||0.054|-0.464|0.1204
71776696|NCT00631696|143052517|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|24.65||||0.2875|TWO_SIDED|95.0|-20.999|70.302||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||70.302|-20.999|0.2875
71834165|NCT02554786|143172210|SUPERIORITY||LS Mean|5.8|STANDARD_ERROR_OF_MEAN|2.29||0.012|TWO_SIDED|95.0|1.3|10.2|||Linear Mixed Model (LMM)|||||10.2|1.3|0.012
71834166|NCT02554786|143172210|SUPERIORITY||LS Mean|9.1|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|4.6|13.6|||LMM|||||13.6|4.6|<0.001
71834167|NCT02554786|143172210|SUPERIORITY||LS Mean|3.4|STANDARD_ERROR_OF_MEAN|2.29||0.135|TWO_SIDED|95.0|-1.1|7.9|||LMM|||||7.9|-1.1|0.135
71834168|NCT02554786|143172211|SUPERIORITY||LS Mean|5.0|STANDARD_ERROR_OF_MEAN|2.25||0.026|TWO_SIDED|95.0|0.6|9.4|||LMM|||||9.4|0.6|0.026
71834169|NCT02554786|143172211|SUPERIORITY||LS Mean|8.1|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|3.7|12.5|||LMM|||||12.5|3.7|<0.001
71834170|NCT02554786|143172211|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|2.25||0.151|TWO_SIDED|95.0|-1.2|7.7|||LMM|||||7.7|-1.2|0.151
71664118|NCT02293863|142841746|OTHER||Difference in event rates|7.91||||0.3168|TWO_SIDED|80.0|-2.64|18.47|||Cochran-Mantel-Haenszel|||||18.47|-2.64|0.3168
71664119|NCT02293863|142841747|OTHER||Difference in event rates|-7.92||||0.6043|TWO_SIDED|80.0|-27.5|11.66|||Cochran-Mantel-Haenszel|||||11.66|-27.50|0.6043
71664120|NCT02293863|142841747|OTHER||Difference in event rates|-14.58||||0.3865|TWO_SIDED|80.0|-36.13|6.97|||Cochran-Mantel-Haenszel|||||6.97|-36.13|0.3865
71664121|NCT02293863|142841748|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||Day 14||9.56|-5.57|0.5379
71664122|NCT02293863|142841748|OTHER||Difference in event rates|4.97||||0.2189|TWO_SIDED|80.0|-3.12|13.05|||Cochran-Mantel-Haenszel|||Day 14||13.05|-3.12|0.2189
71664123|NCT02293863|142841748|OTHER||Difference in event rates|2.14||||0.6594|TWO_SIDED|80.0|-6.04|10.31|||Cochran-Mantel-Haenszel|||Day 30||10.31|-6.04|0.6594
71664124|NCT02293863|142841748|OTHER||Difference in event rates|3.54||||0.5013|TWO_SIDED|80.0|-5.24|12.31|||Cochran-Mantel-Haenszel|||Day 30||12.31|-5.24|0.5013
71741583|NCT00555880|142995411|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|92.4||||0.0296|TWO_SIDED|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl - Placebo)|Analysis of treatment difference||||0.0296
71741584|NCT00555880|142995416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||Signed Rank Test|||Analysis of treatment||||0.0342
71741585|NCT01173601|142995444|SUPERIORITY_OR_OTHER|||||||0.338||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.338
71741586|NCT01173601|142995444|SUPERIORITY_OR_OTHER|||||||0.201||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis|||||||0.201
71741587|NCT03951077|142995465|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.3|TWO_SIDED|90.0|-15.38|3.49|||Cochran-Mantel-Haenszel|||Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.49|-15.38|0.300
71741588|NCT03951077|142995465|SUPERIORITY||Adjusted Response Rate Difference|-5.9||||0.32|TWO_SIDED|90.0|-15.65|3.86|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.86|-15.65|0.320
71741589|NCT03951077|142995465|SUPERIORITY||Adjusted Response Rate Difference|-5.6||||0.315|TWO_SIDED|90.0|-14.87|3.59|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.59|-14.87|0.315
71741590|NCT03951077|142995465|SUPERIORITY||Adjusted Response Rate Difference|-6.7||||0.265|TWO_SIDED|90.0|-16.63|3.19|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||3.19|-16.63|0.265
71741591|NCT03951077|142995465|SUPERIORITY||Adjusted Response Rate Difference|-0.8||||0.914|TWO_SIDED|90.0|-13.1|11.48|||Cochran-Mantel-Haenszel|||Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score \[\< 8, ≥ 8\], and baseline normal/obese status \[BMI \< 30, ≥ 30\]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.||11.48|-13.10|0.914
71741592|NCT03951077|142995466|SUPERIORITY||Least Squares (LS) Mean of Difference|-5.93|STANDARD_ERROR_OF_MEAN|3.429||0.087|TWO_SIDED|90.0|-11.628|-0.231|||MMRM|||P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.231|-11.628|0.087
71741593|NCT03951077|142995466|SUPERIORITY||LS Mean of Difference|-8.83|STANDARD_ERROR_OF_MEAN|3.435||0.012|TWO_SIDED|90.0|-14.533|-3.118|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-3.118|-14.533|0.012
71776697|NCT00631696|143052518|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|32.93||||0.1699|TWO_SIDED|95.0|-14.292|80.158||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||80.158|-14.292|0.1699
71776698|NCT00631696|143052519|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.12||||0.7958|TWO_SIDED|95.0|-52.804|40.558||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||40.558|-52.804|0.7958
71776699|NCT00631696|143052520|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08||||0.4094|TWO_SIDED|95.0|-3.645|1.494||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.494|-3.645|0.4094
71741594|NCT03951077|142995466|SUPERIORITY||LS Mean of Difference|-16.1|STANDARD_ERROR_OF_MEAN|3.356|<|0.001|TWO_SIDED|90.0|-21.673|-10.519|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-10.519|-21.673|<0.001
71741595|NCT03951077|142995466|SUPERIORITY||LS Mean of Difference|-6.15|STANDARD_ERROR_OF_MEAN|3.593||0.091|TWO_SIDED|90.0|-12.116|-0.176|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-0.176|-12.116|0.091
71741596|NCT03951077|142995466|SUPERIORITY||LS Mean of Difference|-11.72|STANDARD_ERROR_OF_MEAN|3.431|<|0.001|TWO_SIDED|90.0|-17.418|-6.016|||MMRM|||P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (\< 8, ≥ 8), and baseline normal/obese status (BMI \< 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.||-6.016|-17.418|< 0.001
71741597|NCT01395901|142995468|NON_INFERIORITY_OR_EQUIVALENCE|For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.|Risk Difference (RD)|-4.4|||||TWO_SIDED|95.0|-10.5|1.7||||||"The null hypothesis (H0) was stated as:~• H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \<-10%~The alternative hypothesis (H1) was stated as:~• H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron \>-10%~A power of 80% was used for sample size computation."||1.7|-10.5|
71741598|NCT01290757|142995505|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.082|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
71741599|NCT01290757|142995505|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.33||||||90.0|119.45|133.6|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.60|119.45|
71741600|NCT01290757|142995506|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.085|||||ONE_SIDED|95.0|||||Mixed Models Analysis||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps||||
71741601|NCT01290757|142995506|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.49||||||90.0|118.69|132.67|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.67|118.69|
71741602|NCT01290757|142995507|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.74||||||90.0|118.32|131.51|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.51|118.32|
71741603|NCT01290757|142995508|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.22||||||90.0|119.36|133.47|||Mixed Models Analysis|||Capsugel vs Qualicaps||133.47|119.36|
71741604|NCT01290757|142995509|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.3||||||90.0|118.42|132.59|||Mixed Models Analysis|||Capsugel vs Qualicaps||132.59|118.42|
71741605|NCT01290757|142995510|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.49||||||90.0|118.11|131.21|||Mixed Models Analysis|||Capsugel vs Qualicaps||131.21|118.11|
71741606|NCT02204072|142995555|OTHER||Hazard Ratio (HR)|0.98||||0.9549|TWO_SIDED|95.0|0.57|1.7|||Two-sided log-rank test.||Cox proportional hazard model. Hazard ratio: Comparison vs Enzalutamide|||1.70|0.57|0.9549
71741607|NCT02204072|142995558|OTHER||Hazard Ratio (HR)|1.19||||0.5425|TWO_SIDED|95.0|0.68|2.06|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzaludamide.|||2.06|0.68|0.5425
71741608|NCT02204072|142995559|OTHER||Hazard Ratio (HR)|1.16||||0.5534|TWO_SIDED|95.0|0.71|1.9|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.90|0.71|0.5534
71741609|NCT02204072|142995560|OTHER||Hazard Ratio (HR)|0.64||||0.1514|TWO_SIDED|95.0|0.35|1.18|||Two-sided log-rank test.||Cox proportional hazards model. Hazard ratio: Comparison vs. Enzalutamide.|||1.18|0.35|0.1514
71741610|NCT02204072|142995564|OTHER||Odds Ratio (OR)|1.579||||0.6186|TWO_SIDED|95.0|0.269|12.515|||Regression, Logistic|Odds ratio, p-value and confidence interval were obtained from logistic regression model.||||12.515|0.269|0.6186
71741611|NCT02204072|142995566|OTHER||Odds Ratio (OR)|1.891||||0.192|TWO_SIDED|95.0|0.727|5.059|||Regression, Logistic||Odds ratio, p-value and confidence interval were obtained from logistic regression model.|||5.059|0.727|0.1920
71741612|NCT04209205|142995567|SUPERIORITY||Marginal difference|25.02|||<|0.0001|TWO_SIDED|95.0|17.61|32.43|||Regression, Logistic|||||32.43|17.61|<.0001
71741613|NCT04209205|142995568|SUPERIORITY||Marginal difference|30.59|||<|0.0001|TWO_SIDED|95.0|21.14|40.05|||Regression, Logistic|||||40.05|21.14|<.0001
71741614|NCT04209205|142995569|SUPERIORITY||Marginal difference|17.17|||<|0.0001|TWO_SIDED|95.0|10.48|23.85|||Regression, Logistic|||||23.85|10.48|<.0001
71741615|NCT04209205|142995570|SUPERIORITY||Marginal difference|41.39|||<|0.0001|TWO_SIDED|95.0|30.64|52.13|||Regression, Logistic|||||52.13|30.64|<.0001
71741616|NCT04209205|142995571|SUPERIORITY||Least squares mean|-1.13|STANDARD_ERROR_OF_MEAN|0.129|<|0.0001|TWO_SIDED|95.0|-1.38|0.87|||Mixed Models Analysis|||||0.87|-1.38|<.0001
71741617|NCT04209205|142995572|SUPERIORITY||Least squares mean|-0.24|STANDARD_ERROR_OF_MEAN|-0.043|<|0.0001|TWO_SIDED|95.0|-0.32|0.15|||Mixed Models Analysis|||||0.15|-0.32|<.0001
71741618|NCT04209205|142995573|SUPERIORITY||Least squares mean|4.13|STANDARD_ERROR_OF_MEAN|0.676|<|0.0001|TWO_SIDED|95.0|2.8|5.46|||Mixed Models Analysis|||||5.46|2.80|<.0001
71741619|NCT04209205|142995574|SUPERIORITY||Least squares mean|2.85|STANDARD_ERROR_OF_MEAN|0.933||0.0024|TWO_SIDED|95.0|1.01|4.68|||Mixed Models Analysis|||||4.68|1.01|0.0024
71741620|NCT04209205|142995575|SUPERIORITY||Least squares mean|-6.11|STANDARD_ERROR_OF_MEAN|1.447|<|0.0001|TWO_SIDED|95.0|-8.96|-3.26|||Mixed Models Analysis|||||-3.26|-8.96|<.0001
71834171|NCT02554786|143172212|SUPERIORITY||LS Mean|2.8|STANDARD_ERROR_OF_MEAN|1.72||0.104|TWO_SIDED|95.0|-0.6|6.2|||LMM|||||6.2|-0.6|0.104
71741621|NCT04209205|142995576|SUPERIORITY||Marginal difference|27.49||||0.0003|TWO_SIDED|95.0|12.43|42.55|||Regression, Logistic|||||42.55|12.43|0.0003
71834172|NCT02554786|143172212|SUPERIORITY||LS Mean|3.9|STANDARD_ERROR_OF_MEAN|1.72||0.024|TWO_SIDED|95.0|0.5|7.3|||LMM|||||7.3|0.5|0.024
71741622|NCT04209205|142995577|SUPERIORITY||Marginal difference|16.35||||0.0102|TWO_SIDED|95.0|3.88|28.82|||Regression, Logistic|||||28.82|3.88|0.0102
71741623|NCT05236257|142995581|OTHER||Hazard Ratio (HR)|0.21||||0.0058|TWO_SIDED|95.0|0.07|0.63|||Cox Proportional Hazards model|Unweighted||||0.63|0.07|0.0058
71741624|NCT05236257|142995581|OTHER|||||||0.0023|||||||Log Rank|Unweighted||||||0.0023
71741625|NCT05236257|142995582|OTHER||Hazard Ratio (HR)|0.23||||0.0703|TWO_SIDED|95.0|0.05|1.13|||Cox Proportional Hazards model|Unweighted||||1.13|0.05|0.0703
71741626|NCT05236257|142995582|OTHER|||||||0.0486|||||||Log Rank|Unweighted||||||0.0486
71741627|NCT05236257|142995583|OTHER||Hazard Ratio (HR)|0.23||||0.696|TWO_SIDED|95.0|0.05|1.12|||Cox Proportional Hazards model|Unweighted||||1.12|0.05|0.696
71741628|NCT05236257|142995583|OTHER|||||||0.0476|||||||Log Rank|Unweighted||||||0.0476
71741629|NCT05236257|142995585|OTHER||Hazard Ratio (HR)|0.79||||0.5713|TWO_SIDED|95.0|0.36|1.77|||Cox Proportional Hazards model|Unweighted||||1.77|0.36|0.5713
71741630|NCT05236257|142995585|OTHER|||||||0.5695|||||||Log Rank|Unweighted||||||0.5695
71741631|NCT05236257|142995586|OTHER||Hazard Ratio (HR)|0.32||||0.32|TWO_SIDED|95.0|0.03|3.06|||Cox Proportional Hazards model|Unweighted||||3.06|0.03|0.3200
71741632|NCT05236257|142995586|OTHER|||||||0.294|||||||Log Rank|Unweighted||||||0.2940
71741633|NCT03071393|142995590|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71741634|NCT03071393|142995591|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71741635|NCT03071393|142995592|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71741636|NCT03071393|142995593|SUPERIORITY||||||<|0.05||||||Uncorrected p values are reported.|Wilcoxon (Mann-Whitney)|||||||<0.05
71741637|NCT00874848|142995599|SUPERIORITY_OR_OTHER|||||||0.2895|||||||Fisher Exact|||||||0.2895
71741638|NCT03559933|142995605|SUPERIORITY||Logistic regression model|95.0|STANDARD_ERROR_OF_MEAN|0.0152||0.0125|TWO_SIDED|95.0|93.15|96.66|||Mixed Models Analysis|Subject and stimulation within subject as random effects with multiple observations per subject was accounted for.||The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects with multiple observations per subject. The null hypothesis was tested comparing the lower bound of the 98.75% two-sided confidence interval for the estimated percent diaphragm capture rate to the performance goal of 80%. If the lower bound was greater than 80%, the null hypothesis was rejected, and the endpoint was considered met.||96.66|93.15|0.0125
71741639|NCT02324816|142995611|OTHER||success proportion|73.7|||||TWO_SIDED|95.0|48.8|90.9||||||||90.9|48.8|
71741640|NCT05169424|142995612|OTHER|Comparison of Stiolto (reference group) versus Trelegy for incidence rate of exacerbation.|Hazard Ratio (HR)|1.133||||0.064|TWO_SIDED|95.0|0.993|1.293|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.293|0.993|0.064
71741641|NCT05169424|142995612|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
71741642|NCT05169424|142995612|OTHER|||||||0.063|||||||Log Rank|||||||0.063
71741643|NCT05169424|142995613|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.169||||0.057|TWO_SIDED|95.0|0.996|1.372|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.372|0.996|0.057
71741644|NCT05169424|142995614|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.116||||0.114|TWO_SIDED|95.0|0.974|1.279|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||1.279|0.974|0.114
71741645|NCT05169424|142995615|OTHER|Comparison of Stiolto (reference group) versus Trelegy.|Hazard Ratio (HR)|1.374||||0.273|TWO_SIDED|95.0|0.779|2.424|||Regression, Cox|Cox regression was for time to first exacerbation and cohort as covariate.||||2.424|0.779|0.273
71741646|NCT05169424|142995616|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.183||||0.429|TWO_SIDED|95.0|0.78|1.792|||Regression, Cox|||||1.792|0.780|0.429
71741647|NCT05169424|142995616|OTHER|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71741648|NCT05169424|142995616|OTHER|||||||0.932|||||||Log Rank|||||||0.932
71741649|NCT05169424|142995617|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|0.979||||0.935|TWO_SIDED|95.0|0.582|1.645|||Regression, Cox|||||1.645|0.582|0.935
71741650|NCT05169424|142995618|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.159||||0.507|TWO_SIDED|95.0|0.75|1.79|||Regression, Cox|||||1.790|0.750|0.507
71741651|NCT05169424|142995619|OTHER|Comparison of Stiolto (reference) versus Trelegy for incidence rate of pneumonia hospitalization.|Hazard Ratio (HR)|1.291||||0.726|TWO_SIDED|95.0|0.309|5.405|||Regression, Cox|||||5.405|0.309|0.726
71741652|NCT05169424|142995620|OTHER|||||||0.874|||||||t-test, 2 sided|||||||0.874
71741653|NCT05169424|142995620|OTHER||Exponential estimate|0.895||||0.01|TWO_SIDED|95.0|0.823|0.974|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.974|0.823|0.01
71741654|NCT05169424|142995621|OTHER|||||||0.899|||||||t-test, 2 sided|||||||0.899
71741655|NCT05169424|142995621|OTHER||Exponential estimate|0.897||||0.012|TWO_SIDED|95.0|0.824|0.976|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||0.976|0.824|0.012
71741656|NCT05169424|142995622|OTHER|||||||0.974|||||||t-test, 2 sided|||||||0.974
71741657|NCT05169424|142995622|OTHER||Exponential estimate|1.135||||0.595|TWO_SIDED|95.0|0.711|1.812|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.812|0.711|0.595
71741658|NCT05169424|142995623|OTHER|||||||0.622|||||||t-test, 2 sided|||||||0.622
71834173|NCT02554786|143172212|SUPERIORITY||LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.73||0.588|TWO_SIDED|95.0|-2.5|4.3|||LMM|||||4.3|-2.5|0.588
71834174|NCT02554786|143172213|SUPERIORITY||LS Mean|6.4|STANDARD_ERROR_OF_MEAN|2.19||0.003|TWO_SIDED|95.0|2.1|10.7|||LMM|||||10.7|2.1|0.003
71834175|NCT02554786|143172213|SUPERIORITY||LS Mean|8.9|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|4.6|13.2|||LMM|||||13.2|4.6|<0.001
71834176|NCT02554786|143172213|SUPERIORITY||LS Mean|4.8|STANDARD_ERROR_OF_MEAN|2.2||0.029|TWO_SIDED|95.0|0.5|9.1|||LMM|||||9.1|0.5|0.029
71741659|NCT05169424|142995623|OTHER||Exponential estimate|1.008||||0.855|TWO_SIDED|95.0|0.928|1.094|||ZINB regression with log link|The costs were modeled using Zero Inflated Negative Binomial (ZINB) regression with log link with cohort as the only covariate.|The analysis was for Stiolto versus Trlegy (Trelegy was the reference group).|||1.094|0.928|0.855
71741660|NCT05169424|142995624|OTHER|||||||0.328|||||||t-test, 2 sided|||||||0.328
71741661|NCT01746225|142995625|SUPERIORITY|||||||0.12||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||0.12
71741662|NCT01746225|142995625|SUPERIORITY|||||||0.03||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.03
71741663|NCT01746225|142995625|SUPERIORITY|||||||0.2||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS\>7 months.||||.20
71741664|NCT02451514|142995673|OTHER||Geometric mean ratio|1.48|||||TWO_SIDED|95.0|1.03|2.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||2.12|1.03|
71741665|NCT02451514|142995673|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.67|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.28|0.67|
71741666|NCT02451514|142995673|OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|95.0|0.97|1.96|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.96|0.97|
71741667|NCT02451514|142995673|OTHER||Geometric mean ratio|1.98|||||TWO_SIDED|95.0|1.27|3.09|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||3.09|1.27|
71741668|NCT02451514|142995673|OTHER||Geometric mean ratio|0.93|||||TWO_SIDED|95.0|0.63|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||1.37|0.63|
71741669|NCT02451514|142995673|OTHER||Geometric mean ratio|1.84|||||TWO_SIDED|95.0|1.2|2.84|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.84|1.20|
71741670|NCT02451514|142995673|OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|95.0|0.96|1.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.85|0.96|
71741671|NCT02451514|142995673|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.7|1.25|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.25|0.70|
71741672|NCT02451514|142995673|OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|95.0|0.91|1.72|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.72|0.91|
71741673|NCT02451514|142995673|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.81|2.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.53|0.81|
71741674|NCT02451514|142995673|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|95.0|0.49|1.37|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.37|0.49|
71741675|NCT02451514|142995673|OTHER||Geometric mean ratio|1.18|||||TWO_SIDED|95.0|0.67|2.06|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||2.06|0.67|
71741676|NCT02451514|142995673|OTHER||Geometric mean ratio|1.92|||||TWO_SIDED|95.0|1.33|2.78|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.78|1.33|
71741677|NCT02451514|142995673|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|95.0|0.61|1.17|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.17|0.61|
71741678|NCT02451514|142995673|OTHER||Geometric mean ratio|1.62|||||TWO_SIDED|95.0|1.13|2.32|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||2.32|1.13|
71741679|NCT02451514|142995673|OTHER||Geometric mean ratio|7.15|||||TWO_SIDED|95.0|4.25|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||12|4.25|
71741680|NCT02451514|142995673|OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.50|0.59|
71741681|NCT02451514|142995673|OTHER||Geometric mean ratio|6.73|||||TWO_SIDED|95.0|4.03|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||11|4.03|
71741682|NCT02451514|142995673|OTHER||Geometric mean ratio|0.61|||||TWO_SIDED|95.0|0.3|1.23|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||1.23|0.30|
71741683|NCT02451514|142995673|OTHER||Geometric mean ratio|5.53|||||TWO_SIDED|95.0|2.96|10.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||10|2.96|
71741684|NCT02451514|142995673|OTHER||Geometric mean ratio|3.38|||||TWO_SIDED|95.0|1.7|6.73|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||6.73|1.70|
71741685|NCT02451514|142995673|OTHER||Geometric mean ratio|2.58|||||TWO_SIDED|95.0|1.2|5.54|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||5.54|1.20|
71741686|NCT02451514|142995673|OTHER||Geometric mean ratio|1.3|||||TWO_SIDED|95.0|0.66|2.56|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.56|0.66|
71741687|NCT02451514|142995673|OTHER||Geometric mean ratio|3.34|||||TWO_SIDED|95.0|1.57|7.11|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||7.11|1.57|
71741688|NCT02451514|142995673|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.51|2.59|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||2.59|0.51|
71776700|NCT00631696|143052521|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15||||0.9064|TWO_SIDED|95.0|-2.649|2.352||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||2.352|-2.649|0.9064
71776701|NCT00631696|143052522|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86||||0.4666|TWO_SIDED|95.0|-3.207|1.477||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).|||1.477|-3.207|0.4666
71776702|NCT01050543|143052531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||<|0.0001|TWO_SIDED|95.0|6.8|9.6|||ANOVA|||To evaluate the efficacy of sugammadex compared to the efficacy of neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a 2-way ANOVA model adjusted for trial site.||9.6|6.8|<0.0001
71776703|NCT00570765|143052532|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||Hierarchical testing strategy was proposed to account for multiple comparisons. Statistical significance was evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10 mg OCA versus placebo, then the statistical significance at alpha=0.05 for the 50 mg OCA versus placebo was evaluated. If no statistical significance was shown at alpha=0.05 at the first step, then the subsequent comparison was not considered statistically significant.||||<0.0001
71776704|NCT00570765|143052533|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Treatment arms compared using 2-sided Wilcoxon-Mann-Whitney test at 5% significance level. Treatment groups were pairwise compared versus placebo.||||||<0.0001
71776705|NCT00570765|143052534|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.||||||<0.01
71776706|NCT03387683|143052547|OTHER||Difference in LSM|0.31121|STANDARD_ERROR_OF_MEAN|0.46184||0.504|TWO_SIDED|95.0|-0.619|1.24141||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo-Dapagliflozin 10 mg)||1.24141|-0.61900|0.504
71776707|NCT03387683|143052548|OTHER||Difference in LSM|1.74969|STANDARD_ERROR_OF_MEAN|2.18363||0.427|TWO_SIDED|95.0|-2.64837|6.14775||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo - Dapagliflozin 10 mg)||6.14775|-2.64837|0.427
71776708|NCT01104155|143052555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|||||||1-sided exact binomial|Based on a one-sided exact binomial test compared to 9%.||||||0.204
71776709|NCT01104155|143052555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||1-sided exact binomial|||||||0.041
71776710|NCT01484132|143052560|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.||||0.58
71776711|NCT01484132|143052560|SUPERIORITY_OR_OTHER||Slope|-0.061||||0.406|TWO_SIDED|95.0|-0.206|0.084||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.084|-0.206|0.406
71776712|NCT01484132|143052560|SUPERIORITY_OR_OTHER||Slope|-0.017||||0.693|TWO_SIDED|95.0|-0.101|0.067||P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.067|-0.101|0.693
71776713|NCT01484132|143052560|SUPERIORITY_OR_OTHER||Slope|-0.123||||0.16|TWO_SIDED|95.0|-0.296|0.05||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.050|-0.296|0.160
71834177|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.039||0.001|TWO_SIDED|95.0|-0.2|-0.05|||LMM|||Week1-26 Mean night-time number of puffs||-0.05|-0.2|0.001
71834178|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.035|TWO_SIDED|95.0|-0.16|-0.01|||LMM|||Week 1-26 Mean night-time number of puffs||-0.01|-0.16|0.035
71834179|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.039||0.261|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-26 Mean night-time number of puffs||0.03|-0.12|0.261
71834180|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.047|<|0.001|TWO_SIDED|95.0|-0.28|-0.09|||LMM|||Week 1-26 Mean daytime number of puffs||-0.09|-0.28|<0.001
71834181|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.047||0.011|TWO_SIDED|95.0|-0.21|-0.03|||LMM|||Week 1-26 Mean daytime number of puffs||-0.03|-0.21|0.011
71834182|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.04|STANDARD_DEVIATION|0.047||0.425|TWO_SIDED|95.0|-0.13|0.06|||LMM|||Week 1-26 Mean daytime number of puffs||0.06|-0.13|0.425
71834183|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.31|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.46|-0.15|||LMM|||Week 1-26 Mean daily number of puffs||-0.15|-0.46|<0.001
71741689|NCT02451514|142995673|OTHER||Geometric mean ratio|2.93|||||TWO_SIDED|95.0|1.4|6.12|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||6.12|1.40|
71741690|NCT02451514|142995673|OTHER||Geometric mean ratio|3.35|||||TWO_SIDED|95.0|1.49|7.57|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||7.57|1.49|
71741691|NCT02451514|142995673|OTHER||Geometric mean ratio|0.52|||||TWO_SIDED|95.0|0.23|1.18|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.18|0.23|
71741692|NCT02451514|142995673|OTHER||Geometric mean ratio|5.94|||||TWO_SIDED|95.0|2.84|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||12|2.84|
71741693|NCT02451514|142995673|OTHER||Geometric mean ratio|3.09|||||TWO_SIDED|95.0|1.38|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||6.92|1.38|
71741694|NCT02451514|142995677|OTHER||Geometric mean ratio|8.5|||||TWO_SIDED|95.0|4.41|16.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||16|4.41|
71741695|NCT02451514|142995677|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|95.0|0.39|1.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||1.27|0.39|
71741696|NCT02451514|142995677|OTHER||Geometric mean ratio|5.97|||||TWO_SIDED|95.0|3.14|11.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.||11|3.14|
71741697|NCT02451514|142995677|OTHER||Geometric mean ratio|197.0|||||TWO_SIDED|95.0|86.0|452.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||452|86|
71741698|NCT02451514|142995677|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|95.0|0.47|2.07|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||2.07|0.47|
71741699|NCT02451514|142995677|OTHER||Geometric mean ratio|193.0|||||TWO_SIDED|95.0|84.0|442.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.||442|84|
71741700|NCT02451514|142995677|OTHER||Geometric mean ratio|3.51|||||TWO_SIDED|95.0|1.96|6.27|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||6.27|1.96|
71741701|NCT02451514|142995677|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|95.0|0.37|1.0|||Mixed Models Analysis|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||1.0|0.37|
71741702|NCT02451514|142995677|OTHER||Geometric mean ratio|2.17|||||TWO_SIDED|95.0|1.23|3.85|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.||3.85|1.23|
71741703|NCT02451514|142995677|OTHER||Geometric mean ratio|3.57|||||TWO_SIDED|95.0|1.84|6.92|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||6.92|1.84|
71776714|NCT01484132|143052560|SUPERIORITY_OR_OTHER||Slope|-0.029||||0.574|TWO_SIDED|95.0|-0.131|0.073||P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.073|-0.131|0.574
71741704|NCT02451514|142995677|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|95.0|0.4|1.29|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||1.29|0.40|
71741705|NCT02451514|142995677|OTHER||Geometric mean ratio|2.55|||||TWO_SIDED|95.0|1.33|4.89|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.||4.89|1.33|
71741706|NCT02451514|142995677|OTHER||Geometric mean ratio|17.0|||||TWO_SIDED|95.0|8.18|35.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||35|8.18|
71741707|NCT02451514|142995677|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.41|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||1.53|0.41|
71741708|NCT02451514|142995677|OTHER||Geometric mean ratio|13.0|||||TWO_SIDED|95.0|6.59|28.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.||28|6.59|
71741709|NCT02451514|142995677|OTHER||Geometric mean ratio|74.0|||||TWO_SIDED|95.0|34.0|160.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||160|34|
71741710|NCT02451514|142995677|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.38|1.53|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||1.53|0.38|
71741711|NCT02451514|142995677|OTHER||Geometric mean ratio|57.0|||||TWO_SIDED|95.0|27.0|121.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.||121|27|
71741712|NCT02451514|142995677|OTHER||Geometric mean ratio|2.66|||||TWO_SIDED|95.0|1.46|4.83|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||4.83|1.46|
71741713|NCT02451514|142995677|OTHER||Geometric mean ratio|6.76|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||12|3.96|
71741714|NCT02451514|142995677|OTHER||Geometric mean ratio|18.0|||||TWO_SIDED|95.0|10.0|32.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.||32|10|
71741715|NCT02451514|142995677|OTHER||Geometric mean ratio|1.4|||||TWO_SIDED|95.0|0.72|2.71|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||2.71|0.72|
71741716|NCT02451514|142995677|OTHER||Geometric mean ratio|21.0|||||TWO_SIDED|95.0|12.0|37.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||37|12|
71664125|NCT02293863|142841748|OTHER||Difference in event rates|2.21||||0.6849|TWO_SIDED|80.0|-6.28|10.69|||Cochran-Mantel-Haenszel|||Day 60||10.69|-6.28|0.6849
71664126|NCT02293863|142841748|OTHER||Difference in event rates|1.68||||0.7633|TWO_SIDED|80.0|-7.38|10.74|||Cochran-Mantel-Haenszel|||Day 60||10.74|-7.38|0.7633
71741717|NCT02451514|142995677|OTHER||Geometric mean ratio|29.0|||||TWO_SIDED|95.0|15.0|55.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.||55|15|
71741718|NCT02451514|142995677|OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|95.0|0.47|1.38|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||1.38|0.47|
71741719|NCT02451514|142995677|OTHER||Geometric mean ratio|19.0|||||TWO_SIDED|95.0|12.0|31.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||31|12|
71741720|NCT02451514|142995677|OTHER||Geometric mean ratio|16.0|||||TWO_SIDED|95.0|9.27|26.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.||26|9.27|
71741721|NCT02451514|142995677|OTHER||Geometric mean ratio|0.46|||||TWO_SIDED|95.0|0.17|1.28|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||1.28|0.17|
71741722|NCT02451514|142995677|OTHER||Geometric mean ratio|20.0|||||TWO_SIDED|95.0|8.2|48.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||48|8.20|
71741723|NCT02451514|142995677|OTHER||Geometric mean ratio|9.13|||||TWO_SIDED|95.0|3.78|22.0|||Miettinen & Nurminen score method|||Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.||22|3.78|
71741724|NCT02451514|142995690|OTHER||Geometric mean ratio|0.49|||||TWO_SIDED|95.0|0.28|0.87|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M14459||0.87|0.28|
71834184|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.081||0.017|TWO_SIDED|95.0|-0.35|-0.03|||LMM|||Week 1-26 Mean daily number of puffs||-0.03|-0.35|0.017
71741725|NCT02451514|142995690|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.4|2.11|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis Serogroup B, M01-0240364||2.11|0.40|
71741726|NCT02451514|142995690|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|95.0|0.5|1.38|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, NZ98/254||1.38|0.50|
71664127|NCT02293863|142841749|OTHER||Mean Difference (Final Values)|-3.73||||0.2407|TWO_SIDED|80.0|-6.41|-1.06|||ANOVA|||||-1.06|-6.41|0.2407
71664128|NCT02293863|142841749|OTHER||Mean Difference (Final Values)|-0.7||||0.8339|TWO_SIDED|80.0|-3.49|2.1|||ANOVA|||||2.10|-3.49|0.8339
71664129|NCT02293863|142841750|OTHER||Mean Difference (Final Values)|-0.33||||0.279|TWO_SIDED|80.0|-0.6|-0.07|||ANOVA|||||-0.07|-0.60|0.2790
71664130|NCT02293863|142841750|OTHER||Mean Difference (Final Values)|-0.42||||0.1909|TWO_SIDED|80.0|-0.7|-0.15|||ANOVA|||||-0.15|-0.70|0.1909
71664131|NCT02293863|142841751|OTHER||Hazard Ratio (HR)|1.01||||0.7413|TWO_SIDED|80.0|0.77|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.77|0.7413
71664132|NCT02293863|142841751|OTHER||Hazard Ratio (HR)|1.32||||0.4763|TWO_SIDED|80.0|0.99|1.77|||Wilcoxon (Mann-Whitney)|||||1.77|0.99|0.4763
71664133|NCT02293863|142841752|OTHER||Hazard Ratio (HR)|1.01||||0.8806|TWO_SIDED|80.0|0.78|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.78|0.8806
71664134|NCT02293863|142841752|OTHER||Hazard Ratio (HR)|1.05||||0.5447|TWO_SIDED|80.0|0.8|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.80|0.5447
71664135|NCT02293863|142841753|OTHER||Hazard Ratio (HR)|0.7||||0.4171|TWO_SIDED|80.0|0.47|1.03|||Wilcoxon (Mann-Whitney)|||||1.03|0.47|0.4171
71664136|NCT02293863|142841753|OTHER||Hazard Ratio (HR)|0.9||||0.8322|TWO_SIDED|80.0|0.61|1.34|||Wilcoxon (Mann-Whitney)|||||1.34|0.61|0.8322
71664137|NCT02293863|142841754|OTHER||Difference in event rates|-1.42||||0.824|TWO_SIDED|80.0|-10.61|7.76|||Cochran-Mantel-Haenszel|||||7.76|-10.61|0.8240
71741727|NCT02451514|142995690|OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|95.0|0.44|1.44|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, M10713||1.44|0.44|
71741728|NCT02451514|142995690|OTHER||Geometric mean ratio|0.6|||||TWO_SIDED|95.0|0.34|1.07|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, H44/76||1.07|0.34|
71741729|NCT02451514|142995690|OTHER||Geometric mean ratio|0.77|||||TWO_SIDED|95.0|0.52|1.12|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup B, 5/99||1.12|0.52|
71741730|NCT02451514|142995690|OTHER||Geometric mean ratio|2.99|||||TWO_SIDED|95.0|1.89|4.75|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup A||4.75|1.89|
71741731|NCT02451514|142995690|OTHER||Geometric mean ratio|4.69|||||TWO_SIDED|95.0|3.01|7.31|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup C||7.31|3.01|
71741732|NCT02451514|142995690|OTHER||Geometric mean ratio|8.6|||||TWO_SIDED|95.0|5.84|13.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup W||13|5.84|
71741733|NCT02451514|142995690|OTHER||Geometric mean ratio|7.03|||||TWO_SIDED|95.0|3.96|12.0|||Miettinen & Nurminen score method|||Between-group GMT ratios against N. meningitidis serogroup Y||12|3.96|
71741734|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for each serotype 1, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.05|0.88|
71776715|NCT01484132|143052561|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.11
71776716|NCT01484132|143052561|SUPERIORITY_OR_OTHER||Slope|0.299||||0.003|TWO_SIDED|95.0|0.105|0.494||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.494|0.105|0.003
71741735|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.75|||||TWO_SIDED|95.0|0.69|0.81||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.81|0.69|
71741736|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.26||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.26|0.96|
71741737|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|1.41|||||TWO_SIDED|95.0|1.18|1.69||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.69|1.18|
71741738|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|1.09|||||TWO_SIDED|95.0|0.99|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.99|
71741739|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.18|0.98|
71741740|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.81|
71741741|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.83|
71741742|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|0.84|||||TWO_SIDED|95.0|0.76|0.92||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.92|0.76|
71741743|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.91|
71741744|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.89|||||TWO_SIDED|95.0|0.82|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.82|
71741745|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||0.80|0.67|
71741746|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.04|||||TWO_SIDED|95.0|0.91|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2||1.20|0.91|
71834185|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.29|TWO_SIDED|95.0|-0.24|-0.07|||LMM|||Week 1-26 Mean daily number of puffs||-0.07|-0.24|0.29
71834186|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.039||0.004|TWO_SIDED|95.0|-0.19|-0.04|||LMM|||Week 1-52 Mean night-time number of puffs||-0.04|-0.19|0.004
71834187|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.019|TWO_SIDED|95.0|-0.17|-0.02|||LMM|||Week 1-52 Mean night-time number of puffs||-0.02|-0.17|0.019
71890868|NCT03093402|143303444|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.982|TWO_SIDED|95.0|-6.32|4.36||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Fatigue T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 mean change from baseline and 95% confidence interval for the Placebo group was -4.7 (-8.3, -1.1).|||4.36|-6.32|0.982
71741747|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.87|||||TWO_SIDED|95.0|0.74|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.04|0.74|
71741748|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.75|||||TWO_SIDED|95.0|0.68|0.83||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.83|0.68|
71741749|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.97|0.80|
71741750|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.83|
71741751|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.98|0.79|
71741752|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.20|0.97|
71741753|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 24F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.15|0.92|
71741754|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.93|||||TWO_SIDED|95.0|0.85|1.01||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.01|0.85|
71741755|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.98|||||TWO_SIDED|95.0|0.9|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.07|0.90|
71741756|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.09|0.82|
71741757|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.62|||||TWO_SIDED|95.0|0.52|0.74||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.74|0.52|
71664138|NCT02293863|142841754|OTHER||Difference in event rates|-1.6||||0.8111|TWO_SIDED|80.0|-11.48|8.28|||Cochran-Mantel-Haenszel|||||8.28|-11.48|0.8111
71664139|NCT02293863|142841755|OTHER||Difference in event rates|2.42||||0.7219|TWO_SIDED|80.0|-6.96|11.8|||Cochran-Mantel-Haenszel|||||11.80|-6.96|0.7219
71664140|NCT02293863|142841755|OTHER||Difference in event rates|0.67||||0.9225|TWO_SIDED|80.0|-9.29|10.64|||Cochran-Mantel-Haenszel|||||10.64|-9.29|0.9225
71664141|NCT02293863|142841756|OTHER||Difference in event rates|1.99||||0.5379|TWO_SIDED|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||||9.56|-5.57|0.5379
71664142|NCT02293863|142841756|OTHER||Difference in event rates|-1.85||||0.3667|TWO_SIDED|80.0|-9.88|6.18|||Cochran-Mantel-Haenszel|||||6.18|-9.88|0.3667
71664143|NCT02293863|142841757|OTHER||Hazard Ratio (HR)|0.66||||0.7827|TWO_SIDED|80.0|0.41|1.07|||Wilcoxon (Mann-Whitney)|||||1.07|0.41|0.7827
71664144|NCT02293863|142841757|OTHER||Hazard Ratio (HR)|0.58||||0.2522|TWO_SIDED|80.0|0.36|0.96|||Wilcoxon (Mann-Whitney)|||||0.96|0.36|0.2522
71664145|NCT03462459|142841771|EQUIVALENCE|Proportional tests (Chi-squared) compared the episodes of C. difficile. Log-rank tests (Kaplan-Meier) were conducted to compare the non-recurrence proportions within the eight-week period. Multivariate Cox proportional hazard regression determined if treatment, age, and number of previous C. difficile episodes were predictors of recurrence.|See comments|-0.11||||0.22|TWO_SIDED|95.0|-35.1|8.0|||Chi-squared||Proportional tests compared episodes of C. difficile recurrence in eight weeks (vancomycin vs. placebo) using Chi-squared test. Log-rank tests compared the non-recurrence proportions within 8 weeks with the Kaplan-Meier method.||"Statistical analyses are primarily reported for the population who were randomized in the study (as randomized). The secondary statistical analyses are reported for the population who completed all three visits (as completed treatment). Proportional tests were conducted to compare the episodes of C. difficile recurrence in eight weeks following the completion of the study intervention in patients receiving vancomycin versus placebo using the Chi-squared test. Log-rank tests were conducted to compare the non-recurrence proportions within the eight-week period in patients receiving vancomycin versus placebo with the Kaplan-Meier method. A nonparametric Wilcoxon rank sum test was used to compare distributions of the number of days to the first recurrence of CDI after starting oral vancomycin or placebo. The significance level was set to be ≤0.05. All statistical analyses were conducted in R statistical software (version 4.4.0; R Core Team, 2024)"|8.0|-35.1|0.22
71664146|NCT03462459|142841773|EQUIVALENCE|Proportional difference tests comparing the proportion of patients with VRE colonization at Visit 3, compared to baseline. Significance level was set to 0.10.||||||0.1|||||||Proportional difference test|||||||0.10
71834188|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.039||0.226|TWO_SIDED|95.0|-0.12|0.03|||LMM|||Week 1-52 Mean night-time number of puffs||0.03|-0.12|0.226
71664147|NCT03452137|142841853|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6804|TWO_SIDED|95.0|0.7|1.26|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, human papillomavirus (HPV) status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.26|0.70|0.6804
71664148|NCT03452137|142841854|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.8371|TWO_SIDED|95.0|0.68|1.36|||Log Rank||HR was estimated by Cox regression.|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.36|0.68|0.8371
71664149|NCT03452137|142841855|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.73|1.32|||Log Rank||HR was estimated by Cox regression|Stratified Analysis: The stratification factors were response to definitive local therapy, HPV status and type of definitive local therapy as per interactive voice or web-based response system (IxRS).||1.32|0.73|0.9115
71664150|NCT03452137|142841856|SUPERIORITY||Difference in Event Free Rate|-0.67||||0.8816|TWO_SIDED|95.0|-9.45|8.11|||Z test|||Difference in EFS Event-Free Rates at 1 year||8.11|-9.45|0.8816
71664151|NCT03452137|142841856|SUPERIORITY||Difference in Event Free Rate|0.46||||0.9234|TWO_SIDED|95.0|-8.86|9.78|||Z test|||Difference in EFS Event-Free Rates at 2 years||9.78|-8.86|0.9234
71664152|NCT03452137|142841856|SUPERIORITY||Difference in Event Free Rate|1.19||||0.809|TWO_SIDED|95.0|-8.49|10.88|||Z test|||Difference in EFS Event-Free Rates at 3 years||10.88|-8.49|0.8090
71664153|NCT03452137|142841856|SUPERIORITY||Difference in Event Free Rate|0.01||||0.9985|TWO_SIDED|95.0|-10.17|10.19|||Z test|||Difference in EFS Event-Free Rates at 4 years||10.19|-10.17|0.9985
71664154|NCT03452137|142841857|SUPERIORITY||Difference in Event Free Rate|5.17||||0.2393|TWO_SIDED|95.0|-3.44|13.79|||Z test|||Difference in EFS Event-Free Rates at 1 year||13.79|-3.44|0.2393
71664155|NCT03452137|142841857|SUPERIORITY||Difference in Event Free Rate|3.61||||0.4472|TWO_SIDED|95.0|-5.69|12.9|||Z test|||Difference in EFS Event-Free Rates at 2 years||12.90|-5.69|0.4472
71664156|NCT03452137|142841857|SUPERIORITY||Difference in Event Free Rate|3.14||||0.5222|TWO_SIDED|95.0|-6.49|12.77|||Z test|||Difference in EFS Event-Free Rates at 3 years||12.77|-6.49|0.5222
71664157|NCT03452137|142841857|SUPERIORITY||Difference in Event Free Rate|1.31||||0.7967|TWO_SIDED|95.0|-8.64|11.26|||Z test|||Difference in EFS Event-Free Rates at 4 years||11.26|-8.64|0.7967
71664158|NCT03452137|142841858|SUPERIORITY||Difference in Event Free Rate|2.77||||0.4819|TWO_SIDED|95.0|-4.95|10.49|||Z test|||Difference in OS Event-Free Rates at 2 years||10.49|-4.95|0.4819
71664159|NCT03452137|142841858|SUPERIORITY||Difference in Event Free Rate|-1.25||||0.7783|TWO_SIDED|95.0|-9.97|7.47|||Z test|||Difference in OS Event-Free Rates at 3 years||7.47|-9.97|0.7783
71664160|NCT03452137|142841858|SUPERIORITY||Difference in Event Free Rate|-1.07||||0.8924|TWO_SIDED|95.0|-16.56|14.42|||Z test|||Difference in OS Event-Free Rates at 5 years||14.42|-16.56|0.8924
71664161|NCT00261443|142841868|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.544||||0.014|TWO_SIDED|95.0|0.332|0.893||Stratified Log-rank Test, controlling for type of mood stabilizer and type of mood episode|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.893|0.332|0.014
71664162|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.911|TWO_SIDED|95.0|-0.16|0.15||ANOVA model, controlling for treatment, mood stabilizer, and index mood episode used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value used for mean change from baseline.|ANOVA/ANCOVA|Means, difference in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.15|-0.16|0.911
71834189|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07|||LMM|||Week 1-52 Mean daytime number of puffs||-0.07|-0.26|<0.001
71834190|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.048||0.002|TWO_SIDED|95.0|-0.24|-0.05|||LMM|||Week 1-52 Mean daytime number of puffs||-0.05|-0.24|0.002
71664163|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.557|TWO_SIDED|95.0|-0.09|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.18|-0.09|0.557
71664164|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.596|TWO_SIDED|95.0|-0.18|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.18|0.596
71664165|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.05||||0.522|TWO_SIDED|95.0|-0.22|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.11|-0.22|0.522
71664166|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.142|TWO_SIDED|95.0|-0.3|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.04|-0.30|0.142
71664167|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.16||||0.092|TWO_SIDED|95.0|-0.35|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.03|-0.35|0.092
71834191|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.384|TWO_SIDED|95.0|-0.14|0.05|||LMM|||Week 1-52 Mean daytime number of puffs||0.05|-0.14|0.384
71664168|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.039|TWO_SIDED|95.0|-0.4|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.01|-0.40|0.039
71664169|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.05|TWO_SIDED|95.0|-0.43|0.0||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.00|-0.43|0.050
71664170|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.064|TWO_SIDED|95.0|-0.4|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.40|0.064
71664171|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.25||||0.017|TWO_SIDED|95.0|-0.46|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.05|-0.46|0.017
71664172|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.039|TWO_SIDED|95.0|-0.43|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.01|-0.43|0.039
71664173|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.015|TWO_SIDED|95.0|-0.48|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.05|-0.48|0.015
71834192|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|-0.44|-0.12|||LMM|||Week 1-52 Mean daily number of puffs||-0.12|-0.44|< 0.001
71834193|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.23|STANDARD_ERROR_OF_MEAN|0.081||0.004|TWO_SIDED|95.0|-0.39|-0.07|||LMM|||Week 1-52 Mean daily number of puffs||-0.07|-0.39|0.004
71834194|NCT02554786|143172214|SUPERIORITY||LS Mean|-0.09|STANDARD_ERROR_OF_MEAN|0.081||0.245|TWO_SIDED|95.0|-0.25|0.06|||LMM|||Week 1-52 Mean daily number of puffs||0.06|-0.25|0.245
71834195|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.72|||Regression, Cox|||Moderate or severe asthma exacerbation||0.72|0.39|<0.001
71834196|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6|||Regression, Cox|||Moderate or severe asthma exacerbation||0.6|0.34|<0.001
71834197|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.209|TWO_SIDED|95.0|0.59|1.12|||Regression, Cox|||Moderate or severe asthma exacerbation||1.12|0.59|0.209
71741758|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.76|0.62|
71741759|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||0.90|0.74|
71741760|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.17||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.17|0.89|
71741761|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.06|0.85|
71741762|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.16|1.44||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.44|1.16|
71741763|NCT03197376|142995699|EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)||1.13|0.89|
71741764|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10%, for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 1|0.7|||||TWO_SIDED|97.5|0.0|1.9||||||||1.9|-0.0|
71741765|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 5|2.8|||||TWO_SIDED|97.5|1.2|5.0||||||||5.0|1.2|
71741766|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6A|5.2|||||TWO_SIDED|97.5|1.1|9.5||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||9.5|1.1|
71741767|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6B|2.0|||||TWO_SIDED|97.5|-2.2|6.4||||||||6.4|-2.2|
71741768|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 7F|1.0|||||TWO_SIDED|97.5|-0.1|2.7||||||||2.7|-0.1|
71741769|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 9V|0.1|||||TWO_SIDED|97.5|-1.9|2.5||||||||2.5|-1.9|
71741770|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 14|-0.3|||||TWO_SIDED|97.5|-1.4|1.0||||||||1.0|-1.4|
71776717|NCT01484132|143052561|SUPERIORITY_OR_OTHER||Slope|0.365||||0.002|TWO_SIDED|95.0|0.145|0.585||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.585|0.145|0.002
71776718|NCT01484132|143052562|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.27
71776719|NCT01484132|143052562|SUPERIORITY_OR_OTHER||Slope|-0.068||||0.48|TWO_SIDED|95.0|-0.258|0.123||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.123|-0.258|0.480
71741771|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19A|18.7|||||TWO_SIDED|97.5|15.1|22.5||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||22.5|15.1|
71664174|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.009|TWO_SIDED|95.0|-0.5|-0.07||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.07|-0.50|0.009
71664175|NCT00261443|142841869|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.28||||0.013|TWO_SIDED|95.0|-0.5|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.50|0.013
71664176|NCT00261443|142841870|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348||||0.013|TWO_SIDED|95.0|0.146|0.829||Stratified Log-rank Test, controlling for type of mood stabilizer and type of index mood episode.|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||0.829|0.146|0.013
71664177|NCT00261443|142841871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.733||||0.384|TWO_SIDED|95.0|0.364|1.479||Stratified Log-rank Test P-value for Equality of Survival Curves|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.|||1.479|0.364|0.384
71741772|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19F|-0.8|||||TWO_SIDED|97.5|-1.9|0.5||||||||0.5|-1.9|
71741773|NCT03197376|142995700|NON_INFERIORITY|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 23F|17.2|||||TWO_SIDED|97.5|13.6|21.1||||||||21.1|13.6|
71741774|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 1 GMC Ratio|2.15|||||TWO_SIDED|97.5|2.0|2.32||||||||2.32|2.00|
71741775|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 5 GMC Ratio|1.37|||||TWO_SIDED|97.5|1.28|1.47||||||||1.47|1.28|
71741776|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6A GMC Ratio|0.89|||||TWO_SIDED|97.5|0.78|1.01||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.01|0.78|
71741777|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6B GMC Ratio|1.07|||||TWO_SIDED|97.5|0.93|1.24||||||||1.24|0.93|
71741778|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 7F GMC Ratio|1.3|||||TWO_SIDED|97.5|1.19|1.41||||||||1.41|1.19|
71741779|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 9V GMC Ratio|0.92|||||TWO_SIDED|97.5|0.85|1.0||||||||1.00|0.85|
71664178|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.955|TWO_SIDED|95.0|-0.73|0.77||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.77|-0.73|0.955
71664179|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.06||||0.895|TWO_SIDED|95.0|-0.83|0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.95|-0.83|0.895
71664180|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.69||||0.144|TWO_SIDED|95.0|-1.61|0.24||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.24|-1.61|0.144
71664181|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.1||||0.047|TWO_SIDED|95.0|-2.19|-0.01||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||-0.01|-2.19|0.047
71741780|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 14 GMC Ratio|1.23|||||TWO_SIDED|97.5|1.1|1.37||||||||1.37|1.10|
71741781|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19A GMC Ratio|1.45|||||TWO_SIDED|97.5|1.3|1.63||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL||1.63|1.30|
71741782|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19F GMC Ratio|0.73|||||TWO_SIDED|97.5|0.67|0.8||||||||0.80|0.67|
71741783|NCT03197376|142995701|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 23F GMC Ratio|1.81|||||TWO_SIDED|97.5|1.63|2.01||||||||2.01|1.63|
71741784|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for diphtheria|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71741785|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Tetanus|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71741786|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hepatitis B|0.4|||||TWO_SIDED|95.0|-0.4|2.5||||||||2.5|-0.4|
71741787|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hib|-0.9|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
71741788|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 1|-0.2|||||TWO_SIDED|95.0|-1.3|1.5||||||||1.5|-1.3|
71741789|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 2|2.8|||||TWO_SIDED|95.0|-3.2|9.3||||||||9.3|-3.2|
71741790|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 3|-0.9|||||TWO_SIDED|95.0|-3.0|1.8||||||||1.8|-3.0|
71741791|NCT03197376|142995702|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Rotavirus|0.2|||||TWO_SIDED|95.0|-7.1|7.1||||||||7.1|-7.1|
71890869|NCT03093402|143303445|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.607|TWO_SIDED|95.0|-4.74|4.91||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||4.91|-4.74|0.607
71741792|NCT03197376|142995703|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-pertussis toxoid|0.82|||||TWO_SIDED|95.0|0.62|1.09||||||||1.09|0.62|
71741793|NCT03197376|142995704|NON_INFERIORITY|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-fimbriae 2/3|0.98|||||TWO_SIDED|95.0|0.77|1.25||||||||1.25|0.77|
71741794|NCT03197376|142995711|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 6A|73.3|||||TWO_SIDED|97.5|69.8|76.3||||||||76.3|69.8|
71741795|NCT03197376|142995711|SUPERIORITY|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 19A|54.7|||||TWO_SIDED|97.5|50.3|58.9||||||||58.9|50.3|
71741796|NCT03197376|142995712|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 6A GMC Ratio|8.51|||||TWO_SIDED|97.5|7.68|9.43||||||||9.43|7.68|
71741797|NCT03197376|142995712|SUPERIORITY|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 19A GMC Ratio|5.64|||||TWO_SIDED|97.5|5.14|6.18||||||||6.18|5.14|
71741798|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 1|17.2|||||TWO_SIDED|95.0|11.0|23.6||||||||23.6|11.0|
71741799|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 5|2.8|||||TWO_SIDED|95.0|0.0|6.2||||||||6.2|-0.0|
71741800|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6A|82.2|||||TWO_SIDED|95.0|76.7|86.6||||||||86.6|76.7|
71741801|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6B|9.4|||||TWO_SIDED|95.0|4.5|14.6||||||||14.6|4.5|
71741802|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 7F|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||||2.2|-1.1|
71741803|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71741804|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type14|-0.8|||||TWO_SIDED|95.0|-4.0|2.2||||||||2.2|-4.0|
71741805|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19A|53.3|||||TWO_SIDED|95.0|46.0|60.1||||||||60.1|46.0|
71890870|NCT03093402|143303445|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.607|TWO_SIDED|95.0|-1.85|7.71||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||7.71|-1.85|0.607
71741806|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19F|-1.6|||||TWO_SIDED|95.0|-4.9|1.2||||||||1.2|-4.9|
71741807|NCT03197376|142995713|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71741808|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 1|3.09|||||TWO_SIDED|95.0|2.4|3.98||||||||3.98|2.40|
71741809|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 5|1.39|||||TWO_SIDED|95.0|1.12|1.72||||||||1.72|1.12|
71741810|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6A|186.0|||||TWO_SIDED|95.0|144.0|241.0||||||||241|144|
71741811|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6B|1.95|||||TWO_SIDED|95.0|1.42|2.69||||||||2.69|1.42|
71741812|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 7F|1.16|||||TWO_SIDED|95.0|0.96|1.39||||||||1.39|0.96|
71741813|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 9V|0.38|||||TWO_SIDED|95.0|0.29|0.49||||||||0.49|0.29|
71741814|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 14|0.92|||||TWO_SIDED|95.0|0.67|1.27||||||||1.27|0.67|
71741815|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19A|13.4|||||TWO_SIDED|95.0|10.2|17.7||||||||17.7|10.2|
71741816|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19F|0.66|||||TWO_SIDED|95.0|0.54|0.81||||||||0.81|0.54|
71741817|NCT03197376|142995714|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 23F|3.03|||||TWO_SIDED|95.0|2.25|4.09||||||||4.09|2.25|
71741818|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.31|1.52||||||||1.52|1.31|
71741819|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.88|||||TWO_SIDED|95.0|0.81|0.95||||||||0.95|0.81|
71741820|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|4.46|||||TWO_SIDED|95.0|4.01|4.96||||||||4.96|4.01|
71741821|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|6.43|||||TWO_SIDED|95.0|5.7|7.26||||||||7.26|5.70|
71741822|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|2.04|||||TWO_SIDED|95.0|1.89|2.19||||||||2.19|1.89|
71741823|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.39|||||TWO_SIDED|95.0|1.29|1.5||||||||1.50|1.29|
71741824|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.35|||||TWO_SIDED|95.0|1.21|1.51||||||||1.51|1.21|
71741825|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|2.64|||||TWO_SIDED|95.0|2.4|2.91||||||||2.91|2.40|
71741826|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.49|||||TWO_SIDED|95.0|1.36|1.63||||||||1.63|1.36|
71741827|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.5|||||TWO_SIDED|95.0|2.29|2.72||||||||2.72|2.29|
71741828|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.17|||||TWO_SIDED|95.0|1.06|1.28||||||||1.28|1.06|
71741829|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.67|||||TWO_SIDED|95.0|0.61|0.74||||||||0.74|0.61|
71741830|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|3.49|||||TWO_SIDED|95.0|2.97|4.11||||||||4.11|2.97|
71741831|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|3.85|||||TWO_SIDED|95.0|3.23|4.59||||||||4.59|3.23|
71741832|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|1.63|||||TWO_SIDED|95.0|1.47|1.82||||||||1.82|1.47|
71741833|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.46|||||TWO_SIDED|95.0|1.31|1.62||||||||1.62|1.31|
71741834|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.21|||||TWO_SIDED|95.0|1.03|1.42||||||||1.42|1.03|
71741835|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|3.6|||||TWO_SIDED|95.0|2.99|4.33||||||||4.33|2.99|
71741836|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.55|||||TWO_SIDED|95.0|1.38|1.75||||||||1.75|1.38|
71741837|NCT03197376|142995715|OTHER|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.29|||||TWO_SIDED|95.0|1.98|2.65||||||||2.65|1.98|
71741838|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 1 GMC Ratio|2.34|||||TWO_SIDED|95.0|2.02|2.71||||||||2.71|2.02|
71741839|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 5 GMC Ratio|1.57|||||TWO_SIDED|95.0|1.38|1.79||||||||1.79|1.38|
71741840|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6A GMC Ratio|11.6|||||TWO_SIDED|95.0|9.67|14.0||||||||14.0|9.67|
71741841|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6B GMC Ratio|1.89|||||TWO_SIDED|95.0|1.65|2.15||||||||2.15|1.65|
71741842|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 7F GMC Ratio|1.57|||||TWO_SIDED|95.0|1.37|1.8||||||||1.80|1.37|
71741843|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 9V GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||||0.99|0.76|
71741844|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 14 GMC Ratio|1.48|||||TWO_SIDED|95.0|1.21|1.82||||||||1.82|1.21|
71741845|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19A GMC Ratio|4.22|||||TWO_SIDED|95.0|3.52|5.06||||||||5.06|3.52|
71741846|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19F GMC Ratio|0.63|||||TWO_SIDED|95.0|0.55|0.73||||||||0.73|0.55|
71741847|NCT03197376|142995716|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 23F GMC Ratio|1.91|||||TWO_SIDED|95.0|1.63|2.24||||||||2.24|1.63|
71741848|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|3.47|||||TWO_SIDED|95.0|2.72|4.44||||||||4.44|2.72|
71741849|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|2.54|||||TWO_SIDED|95.0|2.06|3.13||||||||3.13|2.06|
71741850|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|2.5|||||TWO_SIDED|95.0|1.83|3.42||||||||3.42|1.83|
71741851|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.76|||||TWO_SIDED|95.0|2.48|5.69||||||||5.69|2.48|
71741852|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|3.89|||||TWO_SIDED|95.0|2.92|5.18||||||||5.18|2.92|
71741853|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|6.85|||||TWO_SIDED|95.0|4.45|10.52||||||||10.52|4.45|
71741854|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|2.45|||||TWO_SIDED|95.0|1.64|3.65||||||||3.65|1.64|
71741855|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|3.64|||||TWO_SIDED|95.0|2.47|5.36||||||||5.36|2.47|
71741856|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|2.38|||||TWO_SIDED|95.0|1.8|3.14||||||||3.14|1.80|
71741857|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|4.97|||||TWO_SIDED|95.0|3.49|7.06||||||||7.06|3.49|
71741858|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|6.29|||||TWO_SIDED|95.0|4.97|7.96||||||||7.96|4.97|
71741859|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|3.19|||||TWO_SIDED|95.0|2.56|3.98||||||||3.98|2.56|
71741860|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|6.21|||||TWO_SIDED|95.0|3.55|10.84||||||||10.84|3.55|
71741861|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.25|||||TWO_SIDED|95.0|2.25|4.7||||||||4.70|2.25|
71741862|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|2.81|||||TWO_SIDED|95.0|2.13|3.69||||||||3.69|2.13|
71741863|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|2.95|||||TWO_SIDED|95.0|2.15|4.04||||||||4.04|2.15|
71741864|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|1.62|||||TWO_SIDED|95.0|1.06|2.46||||||||2.46|1.06|
71741865|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|5.98|||||TWO_SIDED|95.0|3.88|9.21||||||||9.21|3.88|
71741866|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|1.97|||||TWO_SIDED|95.0|1.45|2.68||||||||2.68|1.45|
71741867|NCT03197376|142995717|OTHER|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|5.73|||||TWO_SIDED|95.0|3.8|8.63||||||||8.63|3.80|
71741868|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 1|1.84|||||TWO_SIDED|95.0|1.25|2.72||||||||2.72|1.25|
71741869|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 5|1.14|||||TWO_SIDED|95.0|0.79|1.64||||||||1.64|0.79|
71664182|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.39||||0.017|TWO_SIDED|95.0|-2.52|-0.25||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||-0.25|-2.52|0.017
71664183|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.91||||0.003|TWO_SIDED|95.0|-3.15|-0.68||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||-0.68|-3.15|0.003
71664184|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.18|||<|0.001|TWO_SIDED|95.0|-3.47|-0.89||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.89|-3.47|<0.001
71741870|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6A|68.1|||||TWO_SIDED|95.0|37.07|125.09||||||||125.09|37.07|
71741871|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6B|1.75|||||TWO_SIDED|95.0|1.25|2.46||||||||2.46|1.25|
71741872|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 7F|1.73|||||TWO_SIDED|95.0|1.28|2.34||||||||2.34|1.28|
71741873|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 9V|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||||1.32|0.65|
71741874|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 14|2.21|||||TWO_SIDED|95.0|1.38|3.51||||||||3.51|1.38|
71741875|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19A|12.54|||||TWO_SIDED|95.0|7.36|21.37||||||||21.37|7.36|
71741876|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19F|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||||1.46|0.70|
71741877|NCT03197376|142995718|OTHER|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 23F|3.14|||||TWO_SIDED|95.0|2.21|4.45||||||||4.45|2.21|
71741878|NCT03197376|142995719|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for measles|1.7|||||TWO_SIDED|95.0|-3.3|7.4||||||||7.4|-3.3|
71741879|NCT03197376|142995719|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for rubella|1.0|||||TWO_SIDED|95.0|-0.9|4.0||||||||4.0|-0.9|
71741880|NCT03197376|142995719|NON_INFERIORITY|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of \< 0.10.|Absolute difference for yellow fever|2.4|||||TWO_SIDED|95.0|0.2|5.9||||||||5.9|0.2|
71741881|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 1|16.2|||||TWO_SIDED|95.0|8.0|23.7||||||||23.7|8.0|
71741882|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 5|7.2|||||TWO_SIDED|95.0|-1.4|15.8||||||||15.8|-1.4|
71741883|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6A|30.0|||||TWO_SIDED|95.0|21.8|38.1||||||||38.1|21.8|
71741884|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 6B|16.5|||||TWO_SIDED|95.0|10.1|23.6||||||||23.6|10.1|
71664185|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.62|||<|0.001|TWO_SIDED|95.0|-4.06|-1.19||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-1.19|-4.06|<0.001
71741885|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 7F|16.4|||||TWO_SIDED|95.0|8.4|24.5||||||||24.5|8.4|
71741886|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 9V|-0.2|||||TWO_SIDED|95.0|-8.8|8.5||||||||8.5|-8.8|
71741887|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 14|14.7|||||TWO_SIDED|95.0|7.5|22.3||||||||22.3|7.5|
71664186|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-3.7|-0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.95|-3.70|<0.001
71741888|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19A|14.7|||||TWO_SIDED|95.0|7.3|22.5||||||||22.5|7.3|
71741889|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 19F|-13.7|||||TWO_SIDED|95.0|-19.0|-8.0||||||||-8.0|-19.0|
71741890|NCT03197376|142995720|OTHER|Treatment group difference in proportions|Absolute Difference for Type 23F|16.9|||||TWO_SIDED|95.0|8.2|25.4||||||||25.4|8.2|
71741891|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 1 GMC Ratio|1.64|||||TWO_SIDED|95.0|1.42|1.89||||||||1.89|1.42|
71741892|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 5 GMC Ratio|1.2|||||TWO_SIDED|95.0|1.03|1.4||||||||1.40|1.03|
71741893|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6A GMC Ratio|2.36|||||TWO_SIDED|95.0|2.01|2.78||||||||2.78|2.01|
71741894|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 6B GMC Ratio|1.45|||||TWO_SIDED|95.0|1.27|1.66||||||||1.66|1.27|
71741895|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 7F GMC Ratio|1.29|||||TWO_SIDED|95.0|1.12|1.49||||||||1.49|1.12|
71741896|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 9V GMC Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
71741897|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 14 GMC Ratio|1.41|||||TWO_SIDED|95.0|1.15|1.72||||||||1.72|1.15|
71664187|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.78|||<|0.001|TWO_SIDED|95.0|-4.19|-1.37||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-1.37|-4.19|<0.001
71741898|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19A GMC Ratio|1.38|||||TWO_SIDED|95.0|1.14|1.68||||||||1.68|1.14|
71741899|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 19F GMC Ratio|0.61|||||TWO_SIDED|95.0|0.5|0.74||||||||0.74|0.50|
71741900|NCT03197376|142995721|OTHER|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs|Pn IgG type 23F GMC Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.81||||||||1.81|1.24|
71741901|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.05|||||TWO_SIDED|95.0|0.05|0.06||||||||0.06|0.05|
71776720|NCT01484132|143052562|SUPERIORITY_OR_OTHER||Slope|-0.074||||0.501|TWO_SIDED|95.0|-0.293|0.145||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.145|-0.293|0.501
71741902|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.3|||||TWO_SIDED|95.0|0.27|0.33||||||||0.33|0.27|
71741903|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.16||||||||0.16|0.13|
71741904|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.11||||||||0.11|0.10|
71741905|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.1|||||TWO_SIDED|95.0|0.09|0.11||||||||0.11|0.09|
71741906|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.21|||||TWO_SIDED|95.0|0.19|0.23||||||||0.23|0.19|
71741907|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.17||||||||0.17|0.13|
71741908|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26||||||||0.26|0.20|
71741909|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.15||||||||0.15|0.12|
71776721|NCT01484132|143052563|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.41
71776722|NCT01484132|143052563|SUPERIORITY_OR_OTHER||Slope|-0.082||||0.612|TWO_SIDED|95.0|-0.418|0.254||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||0.254|-0.418|0.612
71776723|NCT01484132|143052563|SUPERIORITY_OR_OTHER||Slope|0.078||||0.696|TWO_SIDED|95.0|-0.339|0.495||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.495|-0.339|0.696
71776724|NCT01484132|143052564|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.||||0.76
71776725|NCT01484132|143052564|SUPERIORITY_OR_OTHER||Slope|-0.018||||0.968|TWO_SIDED|95.0|-1.061|1.025||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.||1.025|-1.061|0.968
71776726|NCT01484132|143052564|SUPERIORITY_OR_OTHER||Slope|-0.083||||0.822|TWO_SIDED|95.0|-0.941|0.775||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.||0.775|-0.941|0.822
71776727|NCT02963935|143052618|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.|Treatment difference|-3.45||||0.0003|TWO_SIDED|95.0|-5.31|-1.59|||ANCOVA|Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.|Liraglutide 3.0 mg - placebo|Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide \< μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.||-1.59|-5.31|0.0003
71776728|NCT02963935|143052618|OTHER|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)|Treatment difference|-4.59||||0|TWO_SIDED|95.0|-6.54|-2.64|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.||-2.64|-6.54|0.0000
71776729|NCT02963935|143052619|SUPERIORITY||Odds Ratio (OR)|2.51||||0.0003|TWO_SIDED|95.0|1.53|4.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.14|1.53|0.0003
71776730|NCT02963935|143052619|OTHER||Odds Ratio (OR)|2.84||||0|TWO_SIDED|95.0|1.75|4.61|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||4.61|1.75|0.0000
71776731|NCT02963935|143052620|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0469|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.||3.14|1.01|0.0469
71834198|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.003|TWO_SIDED|95.0|0.36|0.81|||Regression, Cox|||Severe asthma exacerbation||0.81|0.36|0.003
71834199|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.3|0.63|||Regression, Cox|||Severe asthma exacerbation||0.63|0.3|<0.001
71834200|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.115|TWO_SIDED|95.0|0.47|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.47|0.115
71834201|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.51|0.82|||Regression, Cox|||All asthma exacerbation||0.82|0.51|<0.001
71664188|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.71|||<|0.001|TWO_SIDED|95.0|-4.13|-1.29||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-1.29|-4.13|<0.001
71664189|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.38|-1.46||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-1.46|-4.38|<0.001
71664190|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.08|||<|0.001|TWO_SIDED|95.0|-4.59|-1.57||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-1.57|-4.59|<0.001
71741910|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.11|||||TWO_SIDED|95.0|0.1|0.12||||||||0.12|0.10|
71741911|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 1 GMC Ratio|0.07|||||TWO_SIDED|95.0|0.06|0.08||||||||0.08|0.06|
71741912|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 5 GMC Ratio|0.4|||||TWO_SIDED|95.0|0.35|0.45||||||||0.45|0.35|
71741913|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6A GMC Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||||0.86|0.62|
71741914|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 6B GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
71741915|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 7F GMC Ratio|0.12|||||TWO_SIDED|95.0|0.11|0.13||||||||0.13|0.11|
71741916|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 9V GMC Ratio|0.2|||||TWO_SIDED|95.0|0.18|0.22||||||||0.22|0.18|
71741917|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 14 GMC Ratio|0.15|||||TWO_SIDED|95.0|0.13|0.19||||||||0.19|0.13|
71741918|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19A GMC Ratio|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||||0.78|0.52|
71741919|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 19F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
71741920|NCT03197376|142995722|OTHER|The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort.|Pn IgG type 23F GMC Ratio|0.14|||||TWO_SIDED|95.0|0.12|0.16||||||||0.16|0.12|
71741921|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 1|24.2|||||TWO_SIDED|95.0|4.5|42.1||||||||42.1|4.5|
71741922|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 5|9.9|||||TWO_SIDED|95.0|-5.8|25.5||||||||25.5|-5.8|
71741923|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6A|65.6|||||TWO_SIDED|95.0|48.3|78.0||||||||78.0|48.3|
71741924|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 6B|23.2|||||TWO_SIDED|95.0|6.4|39.4||||||||39.4|6.4|
71741925|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 7F|2.0|||||TWO_SIDED|95.0|-5.2|10.8||||||||10.8|-5.2|
71741926|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 9V|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71741927|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type14|4.6|||||TWO_SIDED|95.0|-8.5|18.3||||||||18.3|-8.5|
71741928|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19A|34.4|||||TWO_SIDED|95.0|16.5|50.8||||||||50.8|16.5|
71741929|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 19F|5.0|||||TWO_SIDED|95.0|-8.4|19.2||||||||19.2|-8.4|
71741930|NCT03197376|142995723|OTHER|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster|OPA Type 23F|0.0|||||TWO_SIDED||||||||CI could not be computed due to 100% response rate|||||
71741931|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 1|1.3|||||TWO_SIDED|95.0|0.8|2.1||||||||2.1|0.8|
71664191|NCT00261443|142841873|SUPERIORITY_OR_OTHER_LEGACY||Difference|-3.04|||<|0.001|TWO_SIDED|95.0|-4.55|-1.54||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-1.54|-4.55|<0.001
71664192|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.2||||0.59|TWO_SIDED|95.0|-0.54|0.94||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.94|-0.54|0.590
71664193|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.5||||0.371|TWO_SIDED|95.0|-1.59|0.6||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.60|-1.59|0.371
71741932|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 5|1.3|||||TWO_SIDED|95.0|0.7|2.4||||||||2.4|0.7|
71741933|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6A|14.3|||||TWO_SIDED|95.0|6.3|32.1||||||||32.1|6.3|
71741934|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 6B|3.7|||||TWO_SIDED|95.0|2.1|6.8||||||||6.8|2.1|
71741935|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 7F|1.0|||||TWO_SIDED|95.0|0.6|1.6||||||||1.6|0.6|
71741936|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 9V|0.7|||||TWO_SIDED|95.0|0.3|1.7||||||||1.7|0.3|
71741937|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 14|1.1|||||TWO_SIDED|95.0|0.5|2.4||||||||2.4|0.5|
71741938|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19A|5.1|||||TWO_SIDED|95.0|2.4|10.8||||||||10.8|2.4|
71741939|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 19F|1.0|||||TWO_SIDED|95.0|0.4|2.3||||||||2.3|0.4|
71741940|NCT03197376|142995724|OTHER|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose|OPA GMT Ratio-Type 23F|4.3|||||TWO_SIDED|95.0|2.0|9.4||||||||9.4|2.0|
71741941|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
71741942|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.11|||||TWO_SIDED|95.0|0.09|0.14||||||||0.14|0.09|
71741943|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.05|||||TWO_SIDED|95.0|0.03|0.08||||||||0.08|0.03|
71741944|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||||0.07|0.03|
71741945|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.26|||||TWO_SIDED|95.0|0.18|0.38||||||||0.38|0.18|
71741946|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.12|||||TWO_SIDED|95.0|0.06|0.23||||||||0.23|0.06|
71776732|NCT02963935|143052620|OTHER||Odds Ratio (OR)|2.14||||0.0063|TWO_SIDED|95.0|1.24|3.69|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||3.69|1.24|0.0063
71741947|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.07|||||TWO_SIDED|95.0|0.05|0.11||||||||0.11|0.05|
71741948|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.16|||||TWO_SIDED|95.0|0.09|0.3||||||||0.30|0.09|
71741949|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.05|0.18||||||||0.18|0.05|
71741950|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.12|||||TWO_SIDED|95.0|0.08|0.18||||||||0.18|0.08|
71741951|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 1|0.04|||||TWO_SIDED|95.0|0.03|0.06||||||||0.06|0.03|
71741952|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 5|0.07|||||TWO_SIDED|95.0|0.05|0.1||||||||0.10|0.05|
71741953|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6A|0.21|||||TWO_SIDED|95.0|0.09|0.48||||||||0.48|0.09|
71741954|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 6B|0.02|||||TWO_SIDED|95.0|0.01|0.03||||||||0.03|0.01|
71741955|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 7F|0.44|||||TWO_SIDED|95.0|0.3|0.65||||||||0.65|0.30|
71741956|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 9V|0.11|||||TWO_SIDED|95.0|0.06|0.2||||||||0.20|0.06|
71741957|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 14|0.11|||||TWO_SIDED|95.0|0.06|0.22||||||||0.22|0.06|
71741958|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19A|0.26|||||TWO_SIDED|95.0|0.14|0.49||||||||0.49|0.14|
71741959|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 19F|0.09|||||TWO_SIDED|95.0|0.06|0.14||||||||0.14|0.06|
71741960|NCT03197376|142995725|OTHER|The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort.|OPA GMT Ratio-Type 23F|0.07|||||TWO_SIDED|95.0|0.05|0.12||||||||0.12|0.05|
71741961|NCT01223183|142995731|EQUIVALENCE|alpha=0.05|||||<|0.001|||||||t-test, 2 sided|||Comparing DTPA absorption after hypertonic saline inhalation to DTPA absorption after isotonic saline inhalation||||<0.001
71741962|NCT01223183|142995733|EQUIVALENCE|alpha=0.05||||||0.003|||||||t-test, 2 sided|||Comparing mucociliary clearance after isotonic saline inhalation to mucociliary clearance after hypertonic saline inhalation||||0.003
71834202|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.38|0.6|||Regression, Cox|||All asthma exacerbation||0.6|0.38|<0.001
71664194|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.04||||0.113|TWO_SIDED|95.0|-2.33|0.25||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.25|-2.33|0.113
71741963|NCT02123849|142995736|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.04|||||||t-test, 1 sided|||||||0.04
71741964|NCT02123849|142995737|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
71741965|NCT02123849|142995738|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
71741966|NCT02123849|142995739|OTHER|||||||1|||||||Fisher Exact|||||||1.00
71741967|NCT02123849|142995740|OTHER|||||||0.42|||||||t-test, 2 sided|||||||0.42
71741968|NCT02123849|142995741|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
71741969|NCT02123849|142995742|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided|||||||0.97
71741970|NCT02123849|142995743|NON_INFERIORITY|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.06|||||||t-test, 1 sided|||||||0.06
71741971|NCT02178995|142995766|SUPERIORITY_OR_OTHER|||||||0.037||||||HRTSD p-value = 0.037; p \< 0.05 considered significant|ANOVA|Within-subjects contrasts, n=31, df=1||||||0.037
71741972|NCT02178995|142995766|SUPERIORITY_OR_OTHER|||||||0.055||||||D' p = 0.055. p \< 0.05 considered significant.|ANOVA|Within-subjects contrasts, placebo v 10mg v 20mg.||||||0.055
71741973|NCT02178995|142995766|SUPERIORITY_OR_OTHER|||||||0.758|||||||t-test, 2 sided|||HRTSD 10mg vs 20mg||||0.758
71741974|NCT02178995|142995766|SUPERIORITY_OR_OTHER|||||||0.499|||||||t-test, 2 sided|||d' 10mg vs 20mg||||0.499
71741975|NCT02178995|142995767|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA|||||||0.008
71741976|NCT02178995|142995767|SUPERIORITY_OR_OTHER|||||||0.071|||||||t-test, 2 sided|||SDMT 10mg vs 20mg||||0.071
71741977|NCT02178995|142995768|SUPERIORITY_OR_OTHER|||||||0.154|||||||ANOVA|||||||0.154
71741978|NCT02178995|142995768|SUPERIORITY_OR_OTHER|||||||0.779|||||||t-test, 2 sided|||MCG 10mg vs 20mg||||0.779
71741979|NCT02178995|142995769|SUPERIORITY_OR_OTHER||||||<|0.0001||||||HRTSD P\<0.0001|t-test, 2 sided|||Intra-group comparison, HRTSD||||<0.0001
71741980|NCT02178995|142995769|SUPERIORITY_OR_OTHER|||||||0.001||||||HRTSD p \<0.001 for healthy controls|t-test, 2 sided|||Intra-group comparison, HRTSD, healthy controls||||0.001
71741981|NCT02178995|142995769|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Between-group comparisons by 2-way ANOVA, HRTSD||||0.322
71741982|NCT02178995|142995769|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Intra-group comparison, epilepsy, D'||||<0.0001
71741983|NCT02178995|142995769|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||Intra-group analysis, healthy controls, d'||||0.037
71834203|NCT02554786|143172215|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.185|TWO_SIDED|95.0|0.66|1.08|||Regression, Cox|||All asthma exacerbation||1.08|0.66|0.185
71834204|NCT02554786|143172216|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.337|TWO_SIDED|95.0|0.13|2.03|||Regression, Cox|||||2.03|0.13|0.337
71834205|NCT02554786|143172216|SUPERIORITY||Hazard Ratio (HR)|0.14||||0.063|TWO_SIDED|95.0|0.02|1.11|||Regression, Cox|||||1.11|0.02|0.063
71834206|NCT02554786|143172216|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.599|TWO_SIDED|95.0|0.27|9.7|||Regression, Cox|||||9.7|0.27|0.599
71664195|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.0||||0.128|TWO_SIDED|95.0|-2.28|0.29||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.29|-2.28|0.128
71664196|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.85||||0.205|TWO_SIDED|95.0|-2.16|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.47|-2.16|0.205
71741984|NCT02178995|142995769|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANOVA|||Intra-group analysis by 2-way ANOVA, d'||||0.08
71741985|NCT02178995|142995770|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71741986|NCT02178995|142995770|SUPERIORITY_OR_OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
71741987|NCT02178995|142995770|SUPERIORITY_OR_OTHER|||||||0.443|||||||ANOVA|||Group x time interaction by 2-way ANOVA||||0.443
71741988|NCT02178995|142995771|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71741989|NCT02178995|142995771|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
71741990|NCT02178995|142995771|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANOVA|||Between-groups analysis by 2-way ANOVA||||0.906
71741991|NCT02178995|142995772|SUPERIORITY_OR_OTHER|||||||0.274|||||||t-test, 2 sided|||||||0.274
71741992|NCT02178995|142995773|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71741993|NCT02178995|142995774|SUPERIORITY_OR_OTHER|||||||0.04||||||Hits p = 0.04|ANOVA|||||||0.04
71741994|NCT02178995|142995774|SUPERIORITY_OR_OTHER|||||||0.038||||||Omissions p = 0.038|ANOVA|||||||0.038
71741995|NCT02178995|142995774|SUPERIORITY_OR_OTHER|||||||0.329||||||Commissions p = 0.329|ANOVA|||||||0.329
71741996|NCT02178995|142995774|SUPERIORITY_OR_OTHER|||||||0.876|||||||t-test, 2 sided|||Hits 10mg vs 20mg||||0.876
71741997|NCT02178995|142995774|SUPERIORITY_OR_OTHER|||||||0.932|||||||t-test, 2 sided|||Omissions 10mg vs 20mg||||0.932
71741998|NCT02178995|142995774|SUPERIORITY_OR_OTHER|||||||0.898|||||||t-test, 2 sided|||Commissions 10mg vs 20mg||||0.898
71664197|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.13||||0.125|TWO_SIDED|95.0|-2.59|0.32||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.32|-2.59|0.125
71664198|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.43||||0.061|TWO_SIDED|95.0|-2.92|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.06|-2.92|0.061
71664199|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.51||||0.06|TWO_SIDED|95.0|-3.07|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.06|-3.07|0.060
71741999|NCT02178995|142995775|SUPERIORITY_OR_OTHER|||||||0.7116|||||||t-test, 2 sided|||Comparison of baseline rate of seizures (expressed as seizures per 28 days) pre-trial against the rate experienced during the double-blind portion of our trial.||||0.7116
71742000|NCT02178995|142995776|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Attention/Concentration subscale||||<0.0001
71742001|NCT02178995|142995776|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Memory subscale||||<0.0001
71742002|NCT02178995|142995776|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Language subscale||||0.002
71742003|NCT02178995|142995776|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Energy/fatigue subscale||||0.001
71742004|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Hits v1 vs v5 epilepsy||||0.003
71742005|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Hits v1 vs v5 healthy||||0.033
71742006|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANOVA|||2-way ANOVA epilepsy vs healthy hits||||0.079
71742007|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Omissions epilepsy v1 vs v5||||0.001
71742008|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||Omissions v1 vs v5 healthy||||0.029
71742009|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Epilepsy v healthy ANOVA Omissions||||0.048
71742010|NCT02178995|142995777|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Commissions v1 vs v5 epilepsy||||<0.0001
71742011|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||Commissions v1 vs v5 healthy||||0.42
71742012|NCT02178995|142995777|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANOVA|||Healthy vs epilepsy ANOVA (2-way) commissions||||0.019
71742013|NCT02178995|142995778|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71742014|NCT02178995|142995779|SUPERIORITY_OR_OTHER|||||||0.003||||||Note: Stimulant side-effect score \*decreased\* with addition of open-label stimulant.|t-test, 2 sided|||||||0.003
71742015|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||BDI epilepsy v1 vs v5||||0.014
71742016|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Healthy controls BDI v1 vs v5||||0.04
71742017|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.191|||||||t-test, 2 sided|||Between-group comparison 2-way ANOVA BDI||||0.191
71742018|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 epilepsy||||0.42
71742019|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.477|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 healthy controls||||0.477
71742020|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.792|||||||ANOVA|||Between-groups comparison 2-way ANOVA BAI||||0.792
71664200|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.62||||0.046|TWO_SIDED|95.0|-3.21|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.03|-3.21|0.046
71742021|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.045|||||||t-test, 2 sided|||AES visit 1 vs visit 5 epilepsy||||0.045
71742022|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.646|||||||t-test, 2 sided|||AES visit 1 vs visit 5 healthy controls||||0.646
71742023|NCT02178995|142995780|SUPERIORITY_OR_OTHER|||||||0.222|||||||ANOVA|||Between-groups comparison 2-way ANOVA AES||||0.222
71742024|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.011|||||||t-test, 2 sided|||Health Perceptions||||0.011
71742025|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||Overall QOL (subjectively rated by participants on the scale)||||0.01
71742026|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.164|||||||t-test, 2 sided|||Physical Function||||0.164
71742027|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.065|||||||t-test, 2 sided|||Role Limitations (Emotional)||||0.065
71742028|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.014|||||||t-test, 2 sided|||Role Limitations (Physical)||||0.014
71742029|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.128|||||||t-test, 2 sided|||Pain||||0.128
71742030|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Work/Driving/Social||||0.026
71742031|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.077|||||||t-test, 2 sided|||Emotional Wellbeing||||0.077
71742032|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Health Discouragement||||0.007
71742033|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Seizure Worry||||0.063
71742034|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.609|||||||t-test, 2 sided|||Medication Effects||||0.609
71742035|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.626|||||||t-test, 2 sided|||Social Support||||0.626
71742036|NCT02178995|142995781|SUPERIORITY_OR_OTHER|||||||0.103|||||||t-test, 2 sided|||Social Isolation||||0.103
71742037|NCT02178995|142995782|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Variability v1 vs v5 epilepsy||||<0.0001
71742038|NCT02178995|142995782|SUPERIORITY_OR_OTHER|||||||0.096|||||||t-test, 2 sided|||Variability v1 vs v5 healthy||||0.096
71742039|NCT02178995|142995782|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANOVA|||Variability 2-way ANOVA healthy vs epilepsy||||0.136
71742040|NCT02178995|142995782|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||Perseverations v1 vs v5 epilepsy||||0.17
71742041|NCT02178995|142995782|SUPERIORITY_OR_OTHER|||||||0.104|||||||t-test, 2 sided|||Perseverations v1 vs v5 healthy||||0.104
71742042|NCT02178995|142995782|SUPERIORITY_OR_OTHER|||||||0.661|||||||ANOVA|||Perseverations 2-way ANOVA healthy vs epilepsy||||0.661
71742043|NCT02178995|142995783|SUPERIORITY_OR_OTHER|||||||0.397|||||||ANOVA|||Variability ANOVA||||0.397
71742044|NCT02178995|142995783|SUPERIORITY_OR_OTHER|||||||0.745|||||||ANOVA|||Perseverations ANOVA||||0.745
71742045|NCT02178995|142995783|SUPERIORITY_OR_OTHER|||||||0.362|||||||t-test, 2 sided|||10mg vs 20mg variability||||0.362
71742046|NCT02178995|142995783|SUPERIORITY_OR_OTHER|||||||0.745|||||||t-test, 2 sided|||10mg vs 20mg perseverations||||0.745
71742047|NCT02178995|142995784|SUPERIORITY_OR_OTHER|||||||0.48|||||||ANOVA|||HRT ANOVA||||0.48
71742048|NCT02178995|142995784|SUPERIORITY_OR_OTHER|||||||0.793|||||||t-test, 2 sided|||HRT 10mg vs 20mg||||0.793
71742049|NCT02178995|142995785|SUPERIORITY_OR_OTHER|||||||0.5|||||||t-test, 2 sided|||HRT v1 vs v5 epilepsy||||0.5
71742050|NCT02178995|142995785|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||HRT v1 vs v5 healthy||||0.075
71742051|NCT02178995|142995785|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|||HRT epilepsy vs healthy ANOVA||||0.2
71742052|NCT00587158|142995786|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Fisher Exact|||||||0.0005
71742053|NCT00587158|142995787|SUPERIORITY_OR_OTHER|||||||0.4571||95.0|||||Fisher Exact|||||||0.4571
71742054|NCT00587158|142995788|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Fisher Exact|||||||0.2290
71742055|NCT00587158|142995789|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at baseline was compared between the two treatment groups.||||0.17
71742056|NCT00587158|142995789|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 21 days was compared between the two treatment groups.||||0.005
71742057|NCT00587158|142995789|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at 90 days was compared between the two treatment groups.||||<0.0001
71742058|NCT00587158|142995789|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||The median PTH level at one year was compared between the two treatment groups.||||0.0004
71742059|NCT00587158|142995790|SUPERIORITY_OR_OTHER|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at baseline was compared between the two treatment groups.||||0.833
71742060|NCT00587158|142995790|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 21 days was compared between the two treatment groups.||||0.553
71742061|NCT00587158|142995790|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at 90 days was compared between the two treatment groups.||||0.035
71742062|NCT00587158|142995790|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Wilcoxon (Mann-Whitney)|||The median BAP level at one year was compared between the two treatment groups.||||0.171
71742063|NCT00587158|142995791|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||t-test, 2 sided|||||||0.98
71742064|NCT00587158|142995792|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
71742065|NCT00587158|142995795|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
71742066|NCT00587158|142995796|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
71742067|NCT00587158|142995797|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
71834207|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.65||||0.008|TWO_SIDED|95.0|0.48|0.89|||Generalized linear model|||Moderate or severe asthma exacerbation||0.89|0.48|0.008
71834208|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64|||Generalized linear model|||Moderate or severe asthma exacerbation||0.64|0.35|<0.001
71742068|NCT00587158|142995798|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||The number of subjects with mild interstitial fibrosis (Banff ci score \> 0 and \< 2) at one year was compared between treatment groups.||||1.0
71834209|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.93||||0.669|TWO_SIDED|95.0|0.67|1.29|||Generalized linear model|||Moderate or severe asthma exacerbation||1.29|0.67|0.669
71834210|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.71||||0.108|TWO_SIDED|95.0|0.47|1.08|||Generalized linear model|||Severe asthma exacerbation||1.08|0.47|0.108
71834211|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.67|||Generalized linear model|||Severe asthma exacerbation||0.67|0.31|<0.001
71834212|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.89||||0.597|TWO_SIDED|95.0|0.58|1.37|||Generalized linear model|||Severe asthma exacerbation||1.37|0.58|0.597
71742069|NCT00587158|142995798|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||The number of subjects with moderate to mild interstitial fibrosis (Banff ci score greater than or equal to 2) at one year was compared between treatment groups.||||0.04
71742070|NCT05258149|142995808|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.65|||||TWO_SIDED|95.0|1.1|2.46|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.46|1.10|
71742071|NCT05258149|142995809|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.27|2.79|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A|||2.79|1.27|
71742072|NCT05258149|142995810|NON_INFERIORITY|A Non-Inferiority margin of 10% was used.|Odds Ratio (OR)|0.74|||||TWO_SIDED|98.33|0.42|1.3|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|1.30|0.42|
71742073|NCT05258149|142995811|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|1.58|||||TWO_SIDED|98.33|0.91|2.75|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|2.75|0.91|
71742074|NCT05258149|142995812|SUPERIORITY|A superiority margin of 1 was used.|Odds Ratio (OR)|2.08|||||TWO_SIDED|98.33|1.24|3.5|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Odds Ratio was calculated as senofilcon A C3 over delefilcon A||confidence intervals were adjusted using 98.33% per each secondary endpoint|3.50|1.24|
71742075|NCT02114606|142995827|OTHER|Overall agreement was calculated using Cohen's Kappa, with endoscopic biopsy as the gold standard.||||||0.0001||||||A p-value of \<0.05 was considered statistically significant.|Cohen's Kappa|||All participants enrolled (EoE Patients) provided both a Cytosponge specimen and endoscopic biopsy. The results of these specimens were compared to examine overall agreement.||||0.0001
71742076|NCT03187119|142995832|SUPERIORITY||Slope|1.41||||0.42|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|linear mixed model|||The reference group for this model is the Pictorial Asthma Action Plan Group.||||0.42
71742077|NCT03187119|142995832|SUPERIORITY||Slope|-14.31||||0.03|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
71742078|NCT03187119|142995832|SUPERIORITY||Slope|-0.33||||0.89|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.89
71742079|NCT03187119|142995833|SUPERIORITY||Slope|-1.59||||0.31|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.31
71742080|NCT03187119|142995833|SUPERIORITY||Slope|1.9||||0.73|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.73
71742081|NCT03187119|142995833|SUPERIORITY||Slope|-0.21||||0.92|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of group and time.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.92
71742082|NCT03187119|142995834|SUPERIORITY||Slope|0.52||||0.06|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.06
71742083|NCT03187119|142995834|SUPERIORITY||Slope|-1.57||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 2 for the main effect of group and the time x group interaction.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
71742084|NCT03187119|142995834|SUPERIORITY||Slope|0.37||||0.33|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 2 and 3 for the main effects of group and time.|generalized linear mixed model|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.33
71742085|NCT03187119|142995835|SUPERIORITY||Slope|-0.01||||0.002|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2-3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.002
71776733|NCT02963935|143052621|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0311|TWO_SIDED|95.0|1.08|4.74|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.||4.74|1.08|0.0311
71776734|NCT02963935|143052621|OTHER||Odds Ratio (OR)|2.74||||0.006|TWO_SIDED|95.0|1.33|5.62|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||5.62|1.33|0.0060
71776735|NCT02963935|143052622|SUPERIORITY||Odds Ratio (OR)|3.32|||<|0.0001|TWO_SIDED|95.0|1.93|5.72|||Regression, Logistic||Liraglutide 3.0 mg/placebo|"Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.~Missing values are considered as non-responders."||5.72|1.93|<0.0001
71776736|NCT02963935|143052623|SUPERIORITY||treatment difference|-2.72||||0.0063|TWO_SIDED|95.0|-4.68|-0.77|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||-0.77|-4.68|0.0063
71776737|NCT02963935|143052623|OTHER||Treatment difference|-3.45||||0.002|TWO_SIDED|95.0|-5.62|-1.28|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||-1.28|-5.62|0.0020
71776738|NCT02963935|143052624|SUPERIORITY||Treatment difference|0.16||||0.8137|TWO_SIDED|95.0|-1.19|1.52|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||1.52|-1.19|0.8137
71776739|NCT02963935|143052624|OTHER||Treatment difference|0.16||||0.8053|TWO_SIDED|95.0|-1.12|1.43|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg- placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||1.43|-1.12|0.8053
71776740|NCT02963935|143052625|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|0.87||||0.6916|TWO_SIDED|95.0|-3.41|5.14|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||5.14|-3.41|0.6916
71742086|NCT03187119|142995835|SUPERIORITY||Slope|-0.16||||0.07|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effects of time and prescription and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.07
71776741|NCT02963935|143052625|OTHER||treatment difference|1.25||||0.5572|TWO_SIDED|95.0|-2.95|5.45|||Mixed models repeated measurements (MMRM||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||5.45|-2.95|0.5572
71776742|NCT02963935|143052626|SUPERIORITY|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|3.12||||0.6986|TWO_SIDED|95.0|-12.68|18.92|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.||18.92|-12.68|0.6986
71776743|NCT02963935|143052626|OTHER||Treatment difference|7.66||||0.37|TWO_SIDED|95.0|-9.15|24.48|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.||24.48|-9.15|0.3700
71776744|NCT04502979|143052697|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.21||0.07|TWO_SIDED|95.0|-0.11|0.73||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||0.73|-0.11|0.07
71776745|NCT04502979|143052698|SUPERIORITY||Mean Difference (Net)|-121.16|STANDARD_ERROR_OF_MEAN|65.73||0.04|TWO_SIDED|95.0|-252.73|10.41||One-sided p-value for directional hypothesis. The threshold for statistical significance is p \< 0.05.|Mixed Models Analysis|||||10.41|-252.73|0.04
71742087|NCT03187119|142995835|SUPERIORITY||Slope|0.43||||0.69|TWO_SIDED|||||The results listed here are for the main effect of prescription. Please see Analyses 1-2 for the main effects of time and group and Analyses 4-6 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||.69
71742088|NCT03187119|142995835|SUPERIORITY||Slope|0.02||||0.37|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 5-7 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.37
71834213|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.87|0.52|0.002
71834214|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.59|0.36|<0.001
71742089|NCT03187119|142995835|SUPERIORITY||Slope|-1.14||||0.12|TWO_SIDED|||||The results listed here are for the prescription x group interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4 and 6 for other interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference group for this analysis is the Pictorial Asthma Action Plan group.||||0.12
71742090|NCT03187119|142995835|SUPERIORITY||Slope|0.01||||0.006|TWO_SIDED|||||The results listed here are for the time x PAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||The analyses are modeling lower adherence.|The reference groups for this analysis is the 2x per day group.||||0.006
71742091|NCT03187119|142995835|SUPERIORITY||Slope|0.04||||0.006|TWO_SIDED|||||The results listed here are for the time x WAAP group x prescription interaction. Please see Analyses 1-3 for the main effects of group, time and prescription and Analyses 4-5 for interactions.|generalized linear mixed model||These analyses are modeling lower adherence.|The reference group for this analysis is 2x per day group.||||0.006
71742092|NCT03187119|142995836|SUPERIORITY||Slope|0.08||||0.18|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.18
71742093|NCT03187119|142995836|SUPERIORITY||Slope|-0.09||||0.71|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.71
71742094|NCT03187119|142995836|SUPERIORITY||Slope|0.007||||0.96|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.96
71742095|NCT03187119|142995838|SUPERIORITY||Slope|-0.02||||0.74|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.74
71742096|NCT03187119|142995838|SUPERIORITY||Slope|0.02||||0.83|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.83
71742097|NCT03187119|142995838|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
71742098|NCT03187119|142995839|SUPERIORITY||Slope|0.12||||0.08|TWO_SIDED|||||The results listed here are for the main effect of time. Please see Analyses 2 and 3 for the main effect of group and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.08
71742099|NCT03187119|142995839|SUPERIORITY||Slope|-0.12||||0.25|TWO_SIDED|||||The results listed here are for the main effect of group. Please see Analyses 1 and 3 for the main effect of time and the time x group interaction.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.25
71742100|NCT03187119|142995839|SUPERIORITY||Slope|-0.21||||0.03|TWO_SIDED|||||The results listed here are for the time x group interaction. Please see Analyses 1 and 2 for the main effects of time and group.|multiple linear regression.|||The reference for group for this analysis is the Pictorial Asthma Action Plan group.||||0.03
71742101|NCT01466127|142995852|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71742102|NCT01910402|142995853|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%|Adjusted difference in proportion|10.5||||0.005|TWO_SIDED|95.0|3.1|17.8||If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.|Cochran-Mantel-Haenszel|||||17.8|3.1|0.005
71742103|NCT01910402|142995875|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.026||||0.7053|TWO_SIDED|95.0|-0.159|0.107|||Multiple Imputed Dataset - MAR|||||0.107|-0.159|0.7053
71742104|NCT01910402|142995876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.106||||0.3165|TWO_SIDED|95.0|-0.313|0.101|||Multiple Imputed Dataset - MAR|||||0.101|-0.313|0.3165
71742105|NCT01910402|142995891|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.729|||<|0.001|TWO_SIDED|95.0|0.683|0.779|||ANCOVA||BSAP ratio of Week 48 result over Baseline|||0.779|0.683|<0.001
71742106|NCT01910402|142995891|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.693|||<|0.001|TWO_SIDED|95.0|0.647|0.741|||ANCOVA||PTP ratio of Week 48 result over Baseline|||0.741|0.647|<0.001
71776746|NCT01881373|143052699|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-3.88||||0.02|TWO_SIDED|95.0|-7.29|-0.47|||Regression, Logistic|Hierarchical model.|Intervention vs control communities comparing 24 months to baseline|||-0.47|-7.29|0.02
71834215|NCT02554786|143172217|SUPERIORITY||Rate Ratio|0.95||||0.681|TWO_SIDED|95.0|0.72|1.23|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.23|0.72|0.681
71834216|NCT02554786|143172218|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
71664201|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.15||||0.164|TWO_SIDED|95.0|-2.77|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.47|-2.77|0.164
71834217|NCT02554786|143172218|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
71742107|NCT01910402|142995891|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.629|||<|0.001|TWO_SIDED|95.0|0.581|0.68|||ANCOVA||Osteocalcin ratio of Week 48 result over Baseline|||0.680|0.581|<0.001
71742108|NCT01910402|142995891|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.655|||<|0.0001|TWO_SIDED|95.0|0.609|0.706|||ANCOVA||Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline|||0.706|0.609|<0.0001
71742109|NCT01910402|142995891|SUPERIORITY_OR_OTHER_LEGACY||Ratio of ratio|0.852|||<|0.0001|TWO_SIDED|95.0|0.794|0.914|||ANCOVA||Vitamin D ratio of Week 48 result over Baseline|||0.914|0.794|<0.0001
71742110|NCT01910402|142995893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0||||Week 4|Wilcoxon (Mann-Whitney)|||||||0.016
71742111|NCT01910402|142995893|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Week 12|Wilcoxon (Mann-Whitney)|||||||<0.001
71742112|NCT01910402|142995893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Week 24|Wilcoxon (Mann-Whitney)|||||||0.002
71742113|NCT01910402|142995893|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||Week 48|Wilcoxon (Mann-Whitney)|||||||0.007
71742114|NCT00571038|142995903|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Mixed Models Analysis|||||||0.2417
71742115|NCT00571038|142995904|SUPERIORITY_OR_OTHER|||||||0.8586|TWO_SIDED||||||Mixed Models Analysis|||||||0.8586
71742116|NCT00571038|142995905|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Mixed Models Analysis|||||||0.0432
71742117|NCT00571038|142995906|SUPERIORITY_OR_OTHER|||||||0.0604|TWO_SIDED||||||Mixed Models Analysis|||||||0.0604
71742118|NCT00571038|142995907|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Kruskal-Wallis|||||||0.0438
71742119|NCT00571038|142995908|SUPERIORITY_OR_OTHER|||||||0.1418|TWO_SIDED||||||Kruskal-Wallis|||||||0.1418
71742120|NCT00571038|142995909|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|Two-sided Pr \<= P||||||0.0070
71776747|NCT01881373|143052699|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-2.63||||0.28|TWO_SIDED|95.0|-8.58|3.32||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.32|-8.58|0.28
71776748|NCT01881373|143052700|SUPERIORITY|Hierarchical model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.64||||0.009|TWO_SIDED|95.0|-2.87|-0.41||Intervention vs control communities comparing 78 months to baseline.|Regression, Linear|Hierarchical model.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.41|-2.87|0.009
71776749|NCT01881373|143052700|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|4.35||||0.49|TWO_SIDED|95.0|-8.5|17.24|||Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal comparing 78 months to baseline.||17.24|-8.5|0.49
71776750|NCT01881373|143052701|SUPERIORITY|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-3.6|||<|0.01|TWO_SIDED||||||Regression, Logistic|Hierarchical model||Intervention vs control comparing 24 months to baseline.||||<0.01
71834218|NCT02554786|143172218|SUPERIORITY|||||||0.059|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.059
71834219|NCT02554786|143172218|SUPERIORITY|||||||0.004|||||||Van Elteren Test|||Severe Asthma Exacerbation||||0.004
71834220|NCT02554786|143172218|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||Severe Asthma Exacerbation||||<0.001
71742121|NCT00571038|142995910|SUPERIORITY_OR_OTHER|||||||0.8395|TWO_SIDED||||||Kruskal-Wallis|||||||0.8395
71742122|NCT00571038|142995911|SUPERIORITY_OR_OTHER|||||||0.2194|TWO_SIDED||||||Kruskal-Wallis|||||||0.2194
71742123|NCT00571038|142995912|SUPERIORITY_OR_OTHER|||||||0.9191|TWO_SIDED||||||Kruskal-Wallis|||||||0.9191
71742124|NCT00571038|142995913|SUPERIORITY_OR_OTHER|||||||0.9633|TWO_SIDED||||||Kruskal-Wallis|||||||0.9633
71742125|NCT00571038|142995914|SUPERIORITY_OR_OTHER|||||||0.5901|TWO_SIDED||||||Kruskal-Wallis|||||||0.5901
71742126|NCT00571038|142995915|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Kruskal-Wallis|||||||0.9820
71742127|NCT00571038|142995916|SUPERIORITY_OR_OTHER|||||||0.3979|TWO_SIDED||||||Kruskal-Wallis|||||||0.3979
71742128|NCT00571038|142995917|SUPERIORITY_OR_OTHER|||||||0.1471|TWO_SIDED||||||Kruskal-Wallis|||||||0.1471
71742129|NCT00571038|142995918|SUPERIORITY_OR_OTHER|||||||0.6123|TWO_SIDED||||||Kruskal-Wallis|||||||0.6123
71742130|NCT00571038|142995919|SUPERIORITY_OR_OTHER|||||||0.5861|TWO_SIDED||||||Kruskal-Wallis|||||||0.5861
71742131|NCT00571038|142995920|SUPERIORITY_OR_OTHER|||||||0.4489|TWO_SIDED||||||Kruskal-Wallis|||||||0.4489
71742132|NCT00571038|142995921|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||Kruskal-Wallis|||||||0.2527
71742133|NCT00571038|142995922|SUPERIORITY_OR_OTHER|||||||0.7314|TWO_SIDED||||||Kruskal-Wallis|||||||0.7314
71742134|NCT00571038|142995923|SUPERIORITY_OR_OTHER|||||||0.9839|TWO_SIDED||||||Kruskal-Wallis|||||||0.9839
71742135|NCT02968368|142995979|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0149|TWO_SIDED|95.0|0.102|0.93|||ANCOVA|||||0.930|0.102|0.0149
71742136|NCT02968368|142995984|SUPERIORITY||Mean Difference (Final Values)|39.03|STANDARD_ERROR_OF_MEAN|11.097||0.0006|TWO_SIDED|95.0|17.07|60.992|||ANCOVA|||||60.992|17.070|0.0006
71834221|NCT02554786|143172218|SUPERIORITY|||||||0.025|||||||van Elteren test|||Severe asthma exacerbation||||0.025
71834222|NCT02554786|143172218|SUPERIORITY|||||||0.002|||||||Van Elteren Test|||All(mild, moderate, severe) Asthma Exacerbation||||0.002
71834223|NCT02554786|143172218|SUPERIORITY||||||<|0.001|||||||Van Elteren Test|||All (mild, moderate, severe) Asthma Exacerbation||||<0.001
71834224|NCT02554786|143172218|SUPERIORITY|||||||0.074|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.074
71664202|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.53||||0.066|TWO_SIDED|95.0|-3.16|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.10|-3.16|0.066
71664203|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-1.57||||0.066|TWO_SIDED|95.0|-3.24|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.10|-3.24|0.066
71742137|NCT02968368|142995987|SUPERIORITY||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|1.282||0.0007|TWO_SIDED|95.0|1.928|7.001|||ANCOVA|||||7.001|1.928|0.0007
71742138|NCT02968368|142995988|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.708||0.0098|TWO_SIDED|95.0|0.457|3.261|||ANCOVA|||||3.261|0.457|0.0098
71742139|NCT02859246|142995991|SUPERIORITY||||||<|0.04||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||<0.04
71742140|NCT02859246|142995992|SUPERIORITY||||||<|0.2||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||||||< 0.2
71742141|NCT05280717|142995999|OTHER||Ratio of geometric least square mean|0.9821|||||TWO_SIDED|90.0|0.8825|1.093|||||The ratio estimate and 90% confidence interval were obtained from an Analysis of covariance (ANCOVA) model, with AUC(D1- 29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0930|0.8825|
71742142|NCT05280717|142996000|OTHER||Ratio of geometric least square mean|1.1258|||||TWO_SIDED|90.0|1.0108|1.2539|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.2539|1.0108|
71742143|NCT05280717|142996003|OTHER||Ratio of geometric least square mean|1.876|||||TWO_SIDED|90.0|1.6391|2.1472|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.1472|1.6391|
71742144|NCT05280717|142996003|OTHER||Ratio of geometric least square mean|1.5991|||||TWO_SIDED|90.0|1.4086|1.8153|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUC(D1-29) as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.8153|1.4086|
71742145|NCT05280717|142996004|OTHER||Ratio of geometric least square mean|2.0798|||||TWO_SIDED|90.0|1.8223|2.3737|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||2.3737|1.8223|
71742146|NCT05280717|142996004|OTHER||Ratio of geometric least square mean|1.6955|||||TWO_SIDED|90.0|1.4913|1.9276|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with Cmax as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.9276|1.4913|
71742147|NCT05280717|142996009|OTHER||Ratio of geometric least square mean|0.9476|||||TWO_SIDED|90.0|0.8578|1.0469|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.0469|0.8578|
71742148|NCT05280717|142996009|OTHER||Ratio of geometric least square mean|1.5482|||||TWO_SIDED|90.0|1.377|1.7407|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.7407|1.3770|
71664204|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.08||||0.014|TWO_SIDED|95.0|-3.73|-0.43||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.43|-3.73|0.014
71776751|NCT01881373|143052702|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|change in prevalence between communities|-12.6||||0.003|TWO_SIDED|95.0|-20.92|-4.28||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-4.28|-20.92|0.003
71742149|NCT05280717|142996009|OTHER||Ratio of geometric least square mean|1.4167|||||TWO_SIDED|90.0|1.2627|1.5894|||||The ratio estimate and 90% confidence interval were obtained from an ANCOVA model, with AUCinf as the dependent variable, and sex, baseline body mass index and treatment as covariates.|||1.5894|1.2627|
71742150|NCT00080301|142996017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.0003||95.17|0.64|0.88||Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)|Log Rank|95.17% confidence interval is adjusted for the interim analysis.||Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O'Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.||0.88|0.64|.0003
71742151|NCT00080301|142996018|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.15|||<|0.0001||95.0|2.2|4.5|||Cochran-Mantel-Haenszel|||The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.||4.50|2.20|<.0001
71834225|NCT02554786|143172220|SUPERIORITY||Hazard Ratio (HR)|0.26||||0.222|TWO_SIDED|95.0|0.03|2.29|||Regression, Cox|||||2.29|0.03|0.222
71776752|NCT01881373|143052702|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-3.43||||0.33|TWO_SIDED|95.0|-10.36|3.5||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Temporal communities. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||3.50|-10.36|0.33
71776753|NCT01881373|143052703|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.71||||0.02|TWO_SIDED|95.0|-1.37|-0.05||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||-0.05|-1.37|0.02
71776754|NCT01881373|143052703|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|-0.65||||0.13|TWO_SIDED|95.0|-1.79|0.49||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||0.49|-1.79|0.13
71776755|NCT01881373|143052704|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.01||||0.86|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.86
71776756|NCT01881373|143052705|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.17||||0.68|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.68
71776757|NCT01881373|143052706|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|3.42||||0.55|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.55
71776758|NCT01881373|143052707|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.5||||0.11|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.11
71776759|NCT01881373|143052708|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.7||||0.08|TWO_SIDED||||||Regression, Linear|||mixed model adjusting for age and sex and cluster of community and strata of jurisdiction; intervention vs control comparing 24 months to baseline||||0.08
71776760|NCT01881373|143052709|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.04||||0.71|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.71
71776761|NCT01881373|143052710|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.02||||0.54|TWO_SIDED||||||Regression, Linear|Hierarchical model.||Intervention vs control comparing 24 months to baseline.||||0.54
71776762|NCT01881373|143052711|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.90
71776763|NCT01881373|143052712|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.05||||0.71|TWO_SIDED||||||Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.71
71776764|NCT01881373|143052713|SUPERIORITY|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|||||intervention vs control communities|Regression, Linear|||Intervention vs control comparing 24 months to baseline.||||0.48
71834226|NCT02554786|143172220|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.992|TWO_SIDED|95.0|0.0||The upper limit of CI could not be calculated due to low number of participants with asthma exacerbation.||Regression, Cox||||||0|0.992
71834227|NCT02554786|143172220|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.618|TWO_SIDED|95.0|0.05|6.01|||Regression, Cox|||||6.01|0.05|0.618
71664205|NCT00261443|142841875|SUPERIORITY_OR_OTHER_LEGACY||Difference|-2.01||||0.019|TWO_SIDED|95.0|-3.68|-0.34||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.34|-3.68|0.019
71742152|NCT00080301|142996021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1936||95.17|0.77|1.05||Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse \> 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).|Log Rank|Test was conducted at the α=0.05 level and no adjustments were performed.|Confidence Interval adjusted for interim analysis.|Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.||1.05|0.77|0.1936
71742153|NCT00080301|142996023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||.0002
71742154|NCT02940496|142996024|SUPERIORITY||Correlation Coefficient (2 sided test)|0.081||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
71742155|NCT02940496|142996025|SUPERIORITY||Correlation Coefficient (2-sided test)|0.88||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
71742156|NCT02940496|142996026|SUPERIORITY||Correlation Coefficient (2-sided test)|0.79||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71742157|NCT01147055|142996030|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|18.21|||||TWO_SIDED|90.0|16.14|20.54||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.54|16.14|
71742158|NCT01147055|142996031|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|31.49|||||TWO_SIDED|90.0|26.43|37.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||37.51|26.43|
71742159|NCT01147055|142996032|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|17.6|||||TWO_SIDED|90.0|15.48|20.02||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||20.02|15.48|
71742160|NCT01147055|142996037|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.49|||||TWO_SIDED|90.0|4.64|6.49||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.49|4.64|
71742161|NCT01147055|142996038|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|5.75|||||TWO_SIDED|90.0|4.86|6.81||||||Natural log transformed AUC (0 - ∞) of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||6.81|4.86|
71742162|NCT01147055|142996040|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|11.01|||||TWO_SIDED|90.0|9.02|13.45||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||13.45|9.02|
71776765|NCT01881373|143052714|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|differences in prevalence|-3.6|||<|0.01|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Logistic|Hierarchical model||intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||<0.01
71742163|NCT01895946|142996055|SUPERIORITY_OR_OTHER||Least square mean difference (LSM)|1.02|||||TWO_SIDED|90.0|0.86|1.2|||Mixed Models Analysis|||||1.20|0.86|
71742164|NCT01895946|142996055|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.67|||||TWO_SIDED|90.0|0.55|0.82|||Mixed Models Analysis|||||0.82|0.55|
71742165|NCT01895946|142996056|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.9|||||TWO_SIDED|90.0|0.77|1.06|||Mixed Models Analysis|||||1.06|0.77|
71742166|NCT01895946|142996056|SUPERIORITY_OR_OTHER||Least square means difference (LSM)|0.89|||||TWO_SIDED|90.0|0.76|1.05|||Mixed Models Analysis|||||1.05|0.76|
71742167|NCT03089541|142996064|SUPERIORITY||Odds Ratio (OR)|0.17||||0.002|TWO_SIDED|95.0|0.06|0.52|||Regression, Logistic|||Comparison on Eating/Drinking using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||0.52|0.06|0.002
71742168|NCT03089541|142996064|SUPERIORITY||Odds Ratio (OR)|2.65||||0.07|TWO_SIDED|95.0|0.92|7.65|||Regression, Logistic|||Comparison on Traveling using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||7.65|0.92|0.07
71742169|NCT03089541|142996064|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4|TWO_SIDED|95.0|0.59|3.64|||Regression, Logistic|||Comparison on Working/Reading/Studying using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.64|0.59|0.40
71834228|NCT02554786|143172223|SUPERIORITY||LS Mean|10.1|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|6.2|14.1|||LMM|||Weeks 1-26||14.1|6.2|< 0.001
71664206|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.05||||0.597|TWO_SIDED|95.0|-0.13|0.22||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.22|-0.13|0.597
71664207|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.02||||0.838|TWO_SIDED|95.0|-0.17|0.21||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.21|-0.17|0.838
71664208|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.291|TWO_SIDED|95.0|-0.32|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.10|-0.32|0.291
71664209|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.219|TWO_SIDED|95.0|-0.37|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.08|-0.37|0.219
71664210|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.133|TWO_SIDED|95.0|-0.41|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.05|-0.41|0.133
71664211|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.21||||0.092|TWO_SIDED|95.0|-0.46|0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.04|-0.46|0.092
71664212|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.018|TWO_SIDED|95.0|-0.56|-0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||-0.05|-0.56|0.018
71742170|NCT03089541|142996064|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6|TWO_SIDED|95.0|0.51|3.53|||Regression, Logistic|||Comparison on Socializing using a model adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7). The significance level was 0.05.||3.53|0.51|0.60
71664213|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.029|TWO_SIDED|95.0|-0.56|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.56|0.029
71742171|NCT03089541|142996064|SUPERIORITY||Odds Ratio (OR)|1.8||||0.06|TWO_SIDED|95.0|0.96|3.38|||Regression, Logistic|||Model on Public Space adjusted for timing of the assessment (weekend, time of day (am vs. pm), and day of study (1 to 7)). The significance level was 0.05.||3.38|0.96|0.06
71776766|NCT01881373|143052715|SUPERIORITY|Hierarchical|Mean Difference (Final Values)|0.09||||0.44|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.44
71664214|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.024|TWO_SIDED|95.0|-0.57|-0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.04|-0.57|0.024
71664215|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.035|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.02|-0.56|0.035
71664216|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.038|TWO_SIDED|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.02|-0.56|0.038
71664217|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.07|-0.62|0.015
71834229|NCT02554786|143172223|SUPERIORITY||LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.02|<|0.001|TWO_SIDED|95.0|4.3|12.3|||LMM|||Weeks 1-26||12.3|4.3|<0.001
71834230|NCT02554786|143172223|SUPERIORITY||LS Mean|4.1|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|95.0|0.1|8.0|||LMM|||Weeks 1-26||8|0.1|0.045
71664218|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.39||||0.006|TWO_SIDED|95.0|-0.67|-0.12||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.12|-0.67|0.006
71776767|NCT01881373|143052716|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.16||||0.81|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs. Control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.81
71776768|NCT01881373|143052717|SUPERIORITY|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.37||||0.68|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.68
71776769|NCT01881373|143052718|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.02||||0.69|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.69
71776770|NCT01881373|143052719|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.21||||0.11|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.11
71776771|NCT01881373|143052720|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.06||||0.4|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|||Intervention vs. control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.40
71776772|NCT01881373|143052721|SUPERIORITY|Hierarchical model. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.2||||0.37|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs control. The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.37
71776773|NCT01881373|143052721|SUPERIORITY|Hierarchical model.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Mean Difference (Final Values)|0.18||||0.51|TWO_SIDED|||||The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.|Regression, Linear|The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||Intervention vs temporal.The children from each community recruited each time were NOT the same children. The number of communities is consistent across time.||||0.51
71776774|NCT01686828|143052740|SUPERIORITY_OR_OTHER|||||||0.164||||||The a prior threshold for statistical significance was p\<0.05.|RM-ANOVA|||||||0.164
71776775|NCT01686828|143052741|SUPERIORITY_OR_OTHER|||||||0.003|||||||RM-ANOVA|||Time-by-group interaction for fat mass||||0.003
71776776|NCT01686828|143052741|SUPERIORITY_OR_OTHER|||||||0.03||||||Time-by-group interaction for lean mass|RM-ANOVA|||||||0.03
71776777|NCT01686828|143052742|OTHER||||||>|0.1|||||||ANOVA|||The null hypothesis was that short-term testosterone deprivation would not affect lipoprotein lipase expression in adipose tissue. Repeated measures ANOVA was used to determine if a time-by-group effect was apparent for lipoprotein lipase expression.||||>0.1
71776778|NCT01892865|143052743|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.6||||0.024|TWO_SIDED|95.0|3.15|44.0|||t-test, 2 sided|||The null hypothesis was that there would be no difference in predictive imprecision for the end of the operative day between the two arms||44|3.15|0.024
71776779|NCT01892865|143052743|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson regression|||Null hypothesis: There would be no difference in throughput between the two arms||1.34|1.01|0.04
71776780|NCT01892865|143052744|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.04|TWO_SIDED|95.0|1.01|1.34|||Poisson Regression|||Null hypothesis was that there was no difference in throughput between the two scheduling methods||1.34|1.01|0.04
71776781|NCT01892865|143052745|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||Null hypothesis: There would be no difference in personnel satisfaction between the groups||||0.04
71776782|NCT01892865|143052746|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Null hypothesis was that there would be no difference in the adverse event rates between the two scheduling methodologies||||0.44
71834231|NCT02554786|143172223|SUPERIORITY||LS Mean|9.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|5.7|13.6|||LMM|||Weeks 1-52||13.6|5.7|<0.001
71664219|NCT00261443|142841877|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.35||||0.015|TWO_SIDED|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.07|-0.62|0.015
71664220|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.588|TWO_SIDED|95.0|-0.09|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison||0.16|-0.09|0.588
71664221|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.01||||0.922|TWO_SIDED|95.0|-0.18|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.16|-0.18|0.922
71742172|NCT02863328|142996065|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
71742173|NCT02863328|142996065|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.6|< 0.0001
71742174|NCT02863328|142996065|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
71742175|NCT02863328|142996065|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
71742176|NCT02863328|142996066|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.1|||=|0.7593|TWO_SIDED|95.0|-0.7|0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.7|= 0.7593
71776783|NCT06350474|143052787|NON_INFERIORITY|The non-inferiority margin is -3.|Mean Difference (Final Values)|0.346|||<|0.0001|TWO_SIDED|95.0|-0.5|1.1||One-sided test for non-inferiority.|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||1.1|-0.5|<0.0001
71776784|NCT06350474|143052788|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.414|TWO_SIDED|95.0|-0.4|0.2|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.2|-0.4|0.414
71776785|NCT06350474|143052789|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.241|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||2.9|-1.0|0.241
71776786|NCT06350474|143052790|SUPERIORITY||Mean Difference (Final Values)|-0.92||||0.233|TWO_SIDED|95.0|-2.5|0.6|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.6|-2.5|0.233
71776787|NCT06350474|143052791|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.42|TWO_SIDED|95.0|-0.4|0.97|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.97|-0.4|0.42
71776788|NCT06350474|143052792|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.69|TWO_SIDED|95.0|-0.92|0.61|||t-test, 2 sided||Direction of difference is Discontinue - Continue.|||0.61|-0.92|0.69
71776789|NCT06350474|143052793|SUPERIORITY||Difference in % Participants|2.5||||0.275|TWO_SIDED|95.0|-1.5|6.5|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||6.5|-1.5|0.275
71776790|NCT06350474|143052795|SUPERIORITY||Difference in % Participants|0.8||||0.686|TWO_SIDED|95.0|-1.6|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|||3.4|-1.6|0.686
71776791|NCT06350474|143052796|SUPERIORITY||Difference in % Participants|13.9||||0.001|TWO_SIDED|95.0|5.6|21.8|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||21.8|5.6|0.0010
71776792|NCT06350474|143052797|SUPERIORITY||Rate Ratio|1.95|||<|0.0001|TWO_SIDED|95.0|1.51|2.53|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the DA-discontinue and DA-continue arms are 1486.3 and 1471.4 weeks, respectively. Ratio is Discontinue / Continue.||2.53|1.51|<0.0001
71776793|NCT06350474|143052798|SUPERIORITY||Difference in % Participants|2.03||||0.1758|TWO_SIDED|95.0|-0.6|5.0|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.0|-0.6|0.1758
71776794|NCT00734474|143052820|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying gatekeeping strategies.|LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.55|-0.87|<0.001
71664222|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.266|TWO_SIDED|95.0|-0.3|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.08|-0.30|0.266
71776795|NCT00734474|143052820|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||"Power was estimated at approximately 89% based on a simulation study using the most likely pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used."||-0.31|-0.63|<0.001
71776796|NCT00734474|143052820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.55|-0.87|<0.001
71776797|NCT00734474|143052820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.31|-0.63|<0.001
71776798|NCT00734474|143052822|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26|||<|0.001|TWO_SIDED|95.0|-1.42|-1.09||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-1.09|-1.42|<0.001
71776799|NCT00734474|143052822|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.21|-0.88||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.88|-1.21|<0.001
71776800|NCT00734474|143052822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.81|-0.48||Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.|ANCOVA|||||-0.48|-0.81|<0.001
71834232|NCT02554786|143172223|SUPERIORITY||LS Mean|8.6|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|4.7|12.6|||LMM|||Weeks 1-52||12.6|4.7|<0.001
71834233|NCT02554786|143172223|SUPERIORITY||LS Mean|4.3|STANDARD_ERROR_OF_MEAN|2.04||0.034|TWO_SIDED|95.0|0.3|8.3|||LMM|||Weeks 1-52||8.3|0.3|0.034
71664223|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.159|TWO_SIDED|95.0|-0.34|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.06|-0.34|0.159
71776801|NCT00734474|143052822|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.50|-0.84|<0.001
71664224|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.11||||0.305|TWO_SIDED|95.0|-0.31|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.10|-0.31|0.305
71776802|NCT00734474|143052822|NON_INFERIORITY_OR_EQUIVALENCE|Family-wise Type I error rate controlled by applying gatekeeping strategy.|LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.22|-0.56|<0.001
71776803|NCT00734474|143052822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.50|-0.84|<0.001
71776804|NCT00734474|143052822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis||-0.22|-0.56|<0.001
71776805|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.27|-1.51|||Mixed Models Analysis|Comparison at 26 weeks.||||-1.51|-2.27|<0.001
71776806|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|||<|0.001|TWO_SIDED|95.0|-1.85|-1.1||Comparison at 26 weeks.|Mixed Models Analysis|||||-1.10|-1.85|<0.001
71776807|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.012|TWO_SIDED|95.0|-0.86|-0.11||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.11|-0.86|0.012
71776808|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.47|||<|0.001|TWO_SIDED|95.0|-1.82|-1.13||Comparison at 52 weeks.|Mixed Models Analysis|||||-1.13|-1.82|<0.001
71776809|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-1.07|-0.39||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.39|-1.07|<0.001
71776810|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.51|||<|0.001|TWO_SIDED|95.0|-1.93|-1.1||Comparison at 104 weeks.|Mixed Models Analysis|||||-1.10|-1.93|<0.001
71664225|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.13||||0.251|TWO_SIDED|95.0|-0.35|0.09||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.09|-0.35|0.251
71776811|NCT00734474|143052824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.33|-0.51||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.51|-1.33|<0.001
71776812|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|18.51||||0.095|TWO_SIDED|95.0|-3.25|40.28||Comparison at 26 weeks.|Mixed Models Analysis|||||40.28|-3.25|0.095
71776813|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|17.08||||0.121|TWO_SIDED|95.0|-4.54|38.69||Comparison at 26 weeks.|Mixed Models Analysis|||||38.69|-4.54|0.121
71776814|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|15.41||||0.167|TWO_SIDED|95.0|-6.47|37.29||Comparison at 26 weeks.|Mixed Models Analysis|||||37.29|-6.47|0.167
71776815|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|6.38||||0.43|TWO_SIDED|95.0|-9.49|22.26||Comparison at 52 weeks.|Mixed Models Analysis|||||22.26|-9.49|0.430
71776816|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|8.77||||0.273|TWO_SIDED|95.0|-6.94|24.47||Comparison at 52 weeks.|Mixed Models Analysis|||||24.47|-6.94|0.273
71776817|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|11.07||||0.291|TWO_SIDED|95.0|-9.49|31.64||Comparison at 104 weeks.|Mixed Models Analysis|||||31.64|-9.49|0.291
71776818|NCT00734474|143052825|SUPERIORITY_OR_OTHER||LS Mean Difference|21.28||||0.039|TWO_SIDED|95.0|1.03|41.53||Comparison at 104 weeks.|Mixed Models Analysis|||||41.53|1.03|0.039
71776819|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.27|-1.14||Comparison at 26 weeks.|ANCOVA|||||-1.14|-2.27|<0.001
71776820|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.16|||<|0.001|TWO_SIDED|95.0|-1.73|-0.6||Comparison at 26 weeks.|ANCOVA|||||-0.60|-1.73|<0.001
71776821|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.953|TWO_SIDED|95.0|-0.54|0.58||Comparison at 26 weeks.|ANCOVA|||||0.58|-0.54|0.953
71776822|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|||<|0.001|TWO_SIDED|95.0|-2.08|-0.92||Comparison at 52 weeks.|ANCOVA|||||-0.92|-2.08|<0.001
71776823|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.65|-0.48||Comparison at 52 weeks.|ANCOVA|||||-0.48|-1.65|<0.001
71776824|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.14|||<|0.001|TWO_SIDED|95.0|-1.78|-0.49||Comparison at 104 weeks.|ANCOVA|||||-0.49|-1.78|<0.001
71776825|NCT00734474|143052827|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.64||||0.054|TWO_SIDED|95.0|-1.29|0.01||Comparison at 104 weeks.|ANCOVA|||||0.01|-1.29|0.054
71776826|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.001|TWO_SIDED|95.0|-2.45|-0.93||Comparison at 26 weeks.|Mixed Models Analysis|||||-0.93|-2.45|<0.001
71776827|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.133|TWO_SIDED|95.0|-1.34|0.18||Comparison at 26 weeks.|Mixed Models Analysis|||||0.18|-1.34|0.133
71776828|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.512|TWO_SIDED|95.0|-1.01|0.5||Comparison at 26 weeks.|Mixed Models Analysis|||||0.50|-1.01|0.512
71834234|NCT02554786|143172224|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0462||0.002|TWO_SIDED|95.0|0.056|0.237|||MMRM|||Day 30||0.237|0.056|0.002
71664226|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.135|TWO_SIDED|95.0|-0.4|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.05|-0.40|0.135
71664227|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.073|TWO_SIDED|95.0|-0.46|0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.02|-0.46|0.073
71664228|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.26||||0.034|TWO_SIDED|95.0|-0.5|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||-0.02|-0.50|0.034
71664229|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.17||||0.174|TWO_SIDED|95.0|-0.41|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.07|-0.41|0.174
71664230|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.132|TWO_SIDED|95.0|-0.43|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.06|-0.43|0.132
71664231|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.18||||0.152|TWO_SIDED|95.0|-0.42|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.07|-0.42|0.152
71664232|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.23||||0.06|TWO_SIDED|95.0|-0.48|0.01||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.01|-0.48|0.060
71776829|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69||Comparison at 52 weeks.|Mixed Models Analysis|||||-0.69|-2.23|<0.001
71776830|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.128|TWO_SIDED|95.0|-1.36|0.17||Comparison at 52 weeks.|Mixed Models Analysis|||||0.17|-1.36|0.128
71776831|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.005|TWO_SIDED|95.0|-2.3|-0.42||Comparison at 104 weeks.|Mixed Models Analysis|||||-0.42|-2.30|0.005
71776832|NCT00734474|143052829|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.256|TWO_SIDED|95.0|-1.48|0.4||Comparison at 104 weeks.|Mixed Models Analysis|||||0.40|-1.48|0.256
71776833|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.3|||<|0.001|TWO_SIDED|95.0|6.8|18.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||18.8|6.8|<0.001
71664233|NCT00261443|142841879|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.085|TWO_SIDED|95.0|-0.46|0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.46|0.085
71664234|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.04||||0.774|TWO_SIDED|95.0|-0.25|0.33||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.33|-0.25|0.774
71664235|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.19||||0.213|TWO_SIDED|95.0|-0.49|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.11|-0.49|0.213
71776834|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.6|||<|0.001|TWO_SIDED|95.0|5.2|14.3||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||14.3|5.2|<0.001
71776835|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.8|4.8||Comparison of HbA1c \<7.0% at 26 weeks.|Regression, Logistic|||||4.8|1.8|<0.001
71776836|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.7|5.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||5.9|2.7|<0.001
71776837|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|3.9||Comparison of HbA1c \<7.0% at 52 weeks.|Regression, Logistic|||||3.9|1.8|<0.001
71776838|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|2.4|5.0||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||5.0|2.4|<0.001
71776839|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|3.3||Comparison of HbA1c \<7.0% at 104 weeks.|Regression, Logistic|||||3.3|1.6|<0.001
71776840|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.5|||<|0.001|TWO_SIDED|95.0|6.5|20.4||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||20.4|6.5|<0.001
71742177|NCT02863328|142996066|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.4|||=|0.1358|TWO_SIDED|95.0|-1.0|0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.1|-1.0|= 0.1358
71742178|NCT02863328|142996094|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.85||||0.3552|TWO_SIDED|95.0|0.6|1.2||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.20|0.60|0.3552
71742179|NCT02863328|142996095|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19||Unadjusted two-sided p-value for test of no difference from 1.|Cox proportional hazards model||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.19|0.47|0.2250
71742180|NCT00286429|142996129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.72|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.30|-0.72|<0.001
71742181|NCT00286429|142996129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size \>=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and \>=80% of subjects meeting the per protocol criteria.||-0.37|-0.80|<0.001
71742182|NCT00286429|142996130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001|TWO_SIDED|95.0|-0.34|-0.09||No multiplicity adjustments|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.09|-0.34|<0.001
71742183|NCT00286429|142996130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.20|-0.45|<0.001
71742184|NCT00286429|142996131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.31||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.31|-0.65|<0.001
71776841|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.001|TWO_SIDED|95.0|2.8|8.8||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic|||||8.8|2.8|<0.001
71776842|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.005|TWO_SIDED|95.0|1.3|4.1||Comparison of HbA1c ≤6.5 at 26 weeks.|Regression, Logistic|||||4.1|1.3|0.005
71776843|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4|||<|0.001|TWO_SIDED|95.0|2.9|6.8||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||6.8|2.9|<0.001
71776844|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.5|3.5||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic|||||3.5|1.5|<0.001
71742185|NCT00286429|142996131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.001|TWO_SIDED|95.0|-0.73|-0.39||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.39|-0.73|<0.001
71742186|NCT00286429|142996132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.77|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.77|<0.001
71742187|NCT00286429|142996132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.34|-0.75|<0.001
71742188|NCT00286429|142996133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.79|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.79|<0.001
71742189|NCT00286429|142996133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.33||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.33|-0.75|<0.001
71742190|NCT00286429|142996134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.37|-0.80|<0.001
71742191|NCT00286429|142996134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.79|-0.35||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-0.35|-0.79|<0.001
71742192|NCT00286429|142996135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3||||0.128|TWO_SIDED|95.0|-25.9|3.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||3.3|-25.9|0.128
71776845|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||<|0.001|TWO_SIDED|95.0|3.4|7.9||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||7.9|3.4|<0.001
71776846|NCT00734474|143052830|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.5|3.7||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic|||||3.7|1.5|<0.001
71834235|NCT02554786|143172224|SUPERIORITY||LS Mean|0.123|STANDARD_ERROR_OF_MEAN|0.0464||0.008|TWO_SIDED|95.0|0.032|0.214|||MMRM|||Day 30||0.214|0.032|0.008
71834236|NCT02554786|143172224|SUPERIORITY||LS Mean|0.045|STANDARD_ERROR_OF_MEAN|0.046||0.33|TWO_SIDED|95.0|-0.045|0.135|||MMRM|||Day 30||0.135|-0.045|0.33
71834237|NCT02554786|143172224|SUPERIORITY||LS Mean|0.054|STANDARD_ERROR_OF_MEAN|0.0503||0.28|TWO_SIDED|95.0|-0.044|0.153|||MMRM|||Day 86||0.153|-0.044|0.28
71834238|NCT02554786|143172224|SUPERIORITY||LS Mean|0.118|STANDARD_ERROR_OF_MEAN|0.0507||0.02|TWO_SIDED|95.0|0.019|0.217|||MMRM|||Day 86||0.217|0.019|0.02
71834239|NCT02554786|143172224|SUPERIORITY||LS Mean|0.026|STANDARD_ERROR_OF_MEAN|0.0501||0.598|TWO_SIDED|95.0|-0.072|0.125|||MMRM|||Day 86||0.125|-0.072|0.598
71664236|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.465|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.20|-0.43|0.465
71742193|NCT00286429|142996135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1||||0.034|TWO_SIDED|95.0|-31.1|-1.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.2|-31.1|0.034
71742194|NCT00286429|142996136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.563|TWO_SIDED|95.0|-17.9|9.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||9.7|-17.9|0.563
71742195|NCT00286429|142996136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4||||0.084|TWO_SIDED|95.0|-26.4|1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||1.7|-26.4|0.084
71742196|NCT00286429|142996137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3||||0.16|TWO_SIDED|95.0|-24.7|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-24.7|0.160
71742197|NCT00286429|142996137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.02|TWO_SIDED|95.0|-32.1|-2.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-2.8|-32.1|0.020
71742198|NCT00286429|142996138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9||||0.013|TWO_SIDED|95.0|-33.7|-4.0||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.0|-33.7|0.013
71742199|NCT00286429|142996138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5||||0.011|TWO_SIDED|95.0|-34.5|-4.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.5|-34.5|0.011
71742200|NCT00286429|142996139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.624|TWO_SIDED|95.0|-18.9|11.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||11.3|-18.9|0.624
71776847|NCT00942448|143052853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|||||||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||||< 0.001
71776848|NCT00942448|143052853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1||||0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||||31.7|18.4|0.001
71742201|NCT00286429|142996139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.853|TWO_SIDED|95.0|-16.7|13.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||13.8|-16.7|0.853
71742202|NCT00286429|142996140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.19|TWO_SIDED|95.0|-24.7|4.9||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.9|-24.7|0.190
71742203|NCT00286429|142996140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.154|TWO_SIDED|95.0|-25.8|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||4.1|-25.8|0.154
71742204|NCT00286429|142996141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.097|TWO_SIDED|95.0|-27.8|2.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||2.3|-27.8|0.097
71742205|NCT00286429|142996141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9||||0.01|TWO_SIDED|95.0|-35.1|-4.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-4.7|-35.1|0.010
71742206|NCT00286429|142996142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.662|TWO_SIDED|95.0|-19.2|12.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||12.2|-19.2|0.662
71742207|NCT00286429|142996142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6||||0.03|TWO_SIDED|95.0|-33.4|-1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||-1.7|-33.4|0.030
71742208|NCT00286429|142996143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.551||||0.075|TWO_SIDED|95.0|0.286|1.063||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||1.063|0.286|0.075
71834240|NCT02554786|143172224|SUPERIORITY||LS Mean|0.127|STANDARD_ERROR_OF_MEAN|0.0526||0.016|TWO_SIDED|95.0|0.023|0.23|||MMRM|||Day 183||0.23|0.023|0.016
71834241|NCT02554786|143172224|SUPERIORITY||LS Mean|0.156|STANDARD_ERROR_OF_MEAN|0.0529||0.003|TWO_SIDED|95.0|0.053|0.26|||MMRM|||Day 183||0.26|0.053|0.003
71834242|NCT02554786|143172224|SUPERIORITY||LS Mean|0.085|STANDARD_ERROR_OF_MEAN|0.0525||0.103|TWO_SIDED|95.0|-0.017|0.188|||MMRM|||Day 183||0.188|-0.017|0.103
71834243|NCT02554786|143172224|SUPERIORITY||LS Mean|0.071|STANDARD_ERROR_OF_MEAN|0.0542||0.188|TWO_SIDED|95.0|-0.035|0.178|||MMRM|||Day 254||0.178|-0.035|0.188
71834244|NCT02554786|143172224|SUPERIORITY||LS Mean|0.168|STANDARD_ERROR_OF_MEAN|0.0543||0.002|TWO_SIDED|95.0|0.061|0.274|||MMRM|||Day 254||0.274|0.061|0.002
71664237|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.068|TWO_SIDED|95.0|-0.59|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.02|-0.59|0.068
71664238|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.27||||0.095|TWO_SIDED|95.0|-0.58|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.05|-0.58|0.095
71742209|NCT00286429|142996143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.002|TWO_SIDED|95.0|0.191|0.695||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.695|0.191|0.002
71742210|NCT00286429|142996144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.198|0.619||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo arm. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.619|0.198|<0.001
71742211|NCT00286429|142996144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.339|||<|0.001|TWO_SIDED|95.0|0.189|0.608||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||0.608|0.189|<0.001
71742212|NCT00286429|142996145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.286|TWO_SIDED|95.0|-0.131|0.443||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.443|-0.131|0.286
71742213|NCT00286429|142996145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477||||0.001|TWO_SIDED|95.0|0.188|0.765||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.765|0.188|0.001
71742214|NCT00286429|142996146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202||||0.236|TWO_SIDED|95.0|-0.132|0.536||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.536|-0.132|0.236
71776849|NCT00942448|143052866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.2|||<|0.001|TWO_SIDED|95.0|17.6|30.8|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||30.8|17.6|< 0.001
71776850|NCT00942448|143052866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|18.4|31.7|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."||31.7|18.4|<0.001
71664239|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.082|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.082
71776851|NCT03089320|143052867|SUPERIORITY||posterior mean proportion of abstinence|9.12|||||TWO_SIDED|95.0|0.08|31.68|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||31.68|0.08|
71776852|NCT03089320|143052868|SUPERIORITY||posterior mean proportion of abstinence|5.5|||||TWO_SIDED|95.0|0.17|18.23|||||The lower and upper limits are credible intervals.|Bayesian analysis was performed, therefore p value is not reported. Bayes factor has been reported instead.||18.23|0.17|
71742215|NCT00286429|142996146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372||||0.032|TWO_SIDED|95.0|0.032|0.712||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.712|0.032|0.032
71742216|NCT00286429|142996147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126||||0.562|TWO_SIDED|95.0|-0.302|0.554||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.554|-0.302|0.562
71742217|NCT00286429|142996147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183||||0.407|TWO_SIDED|95.0|-0.251|0.616||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.616|-0.251|0.407
71742218|NCT00286429|142996148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078||||0.716|TWO_SIDED|95.0|-0.344|0.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.500|-0.344|0.716
71742219|NCT00286429|142996148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156||||0.474|TWO_SIDED|95.0|-0.272|0.583||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.583|-0.272|0.474
71742220|NCT00286429|142996149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.7|TWO_SIDED|95.0|-0.324|0.482||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.482|-0.324|0.700
71742221|NCT00286429|142996149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.839|TWO_SIDED|95.0|-0.366|0.45||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.450|-0.366|0.839
71776853|NCT03089320|143052869|SUPERIORITY||Mean Difference (Final Values)|-4.32|STANDARD_ERROR_OF_MEAN|2.84||0.05|TWO_SIDED|95.0|-9.97|1.34|||Mixed Models Analysis|||mixed effects model||1.34|-9.97|.05
71776854|NCT05203289|143052933|OTHER||Ratio of geometric means (%)|101.88|||||TWO_SIDED|90.0|93.31|111.23|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 105.455."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||111.23|93.31|
71776855|NCT05203289|143052934|OTHER||Ratio of geometric means (%)|105.38|||||TWO_SIDED|90.0|95.06|116.81|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 106.431."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||116.81|95.06|
71834245|NCT02554786|143172224|SUPERIORITY||LS Mean|0.061|STANDARD_ERROR_OF_MEAN|0.0538||0.258|TWO_SIDED|95.0|-0.045|0.166|||MMRM|||Day 254||0.166|-0.045|0.258
71834246|NCT02554786|143172224|SUPERIORITY||LS Mean|0.079|STANDARD_ERROR_OF_MEAN|0.0552||0.154|TWO_SIDED|95.0|-0.03|0.187|||MMRM|||Day 364||0.187|-0.030|0.154
71834247|NCT02554786|143172224|SUPERIORITY||LS Mean|0.191|STANDARD_ERROR_OF_MEAN|0.0553|<|0.001|TWO_SIDED|95.0|0.082|0.299|||MMRM|||Day 364||0.299|0.082|<0.001
71834248|NCT02554786|143172224|SUPERIORITY||LS Mean|0.041|STANDARD_ERROR_OF_MEAN|0.0548||0.455|TWO_SIDED|95.0|-0.067|0.148|||MMRM|||Day 364||0.148|-0.067|0.455
71742222|NCT00286429|142996150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282||||0.091|TWO_SIDED|95.0|-0.045|0.61||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.610|-0.045|0.091
71742223|NCT00286429|142996150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.459|TWO_SIDED|95.0|-0.207|0.457||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.457|-0.207|0.459
71742224|NCT00286429|142996152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.65||||0.016|TWO_SIDED|95.0|1.589|100.682||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||100.682|1.589|0.016
71742225|NCT00286429|142996152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.255||||0.023|TWO_SIDED|95.0|1.401|90.379||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo was evaluated inferentially with a Wald test at the 0.05 significance level||90.379|1.401|0.023
71742226|NCT00286429|142996153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.777|||<|0.001|TWO_SIDED|95.0|2.047|16.305||No multiplicity adjustments.|ANCOVA|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||16.305|2.047|<0.001
71742227|NCT00286429|142996153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.784|||<|0.001|TWO_SIDED|95.0|3.54|27.039||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||27.039|3.540|<0.001
71742228|NCT00286429|142996154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.674|||<|0.001|TWO_SIDED|95.0|1.579|4.53||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.530|1.579|<0.001
71742229|NCT00286429|142996154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.819|||<|0.001|TWO_SIDED|95.0|1.653|4.808||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||4.808|1.653|<0.001
71834249|NCT02554786|143172225|NON_INFERIORITY|QMF 150/320 was considered non-inferior to S/F 50/500 if the lower bound of the 95% CI was above the non-inferiority margin of -90 mL and was considered superior if the lower bound of the 95% CI was \> 0. The p-value is for null-hypothesis testing.|LS Mean|0.036|STANDARD_ERROR_OF_MEAN|0.0222||0.101|TWO_SIDED|95.0|-0.007|0.08|||MMRM|||||0.080|-0.007|0.101
71834250|NCT00976495|143172245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.07|STANDARD_ERROR_OF_MEAN|2.7177|||TWO_SIDED|95.0|-13.34|-2.49|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.49|-13.34|
71834251|NCT00976495|143172245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.62|STANDARD_ERROR_OF_MEAN|2.7068|||TWO_SIDED|95.0|-12.87|-2.06|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||-2.06|-12.87|
71742230|NCT00286429|142996155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.163|||<|0.001|TWO_SIDED|95.0|1.651|6.06||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||6.060|1.651|<0.001
71742231|NCT00286429|142996155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.989|||<|0.001|TWO_SIDED|95.0|2.083|7.64||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||7.640|2.083|<0.001
71742232|NCT00286429|142996156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.55||||0.002|TWO_SIDED|95.0|1.732|11.953||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||11.953|1.732|0.002
71742233|NCT00286429|142996156|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.74|12.052||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.||12.052|1.740|0.002
71742234|NCT00286429|142996158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.291|TWO_SIDED|95.0|-0.81|0.24||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.24|-0.81|0.291
71742235|NCT00286429|142996158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.439|TWO_SIDED|95.0|-0.74|0.32||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.32|-0.74|0.439
71742236|NCT00286429|142996159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.841|TWO_SIDED|95.0|-0.67|0.55||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.55|-0.67|0.841
71776856|NCT05203289|143052935|OTHER||Ratio of geometric means (%)|91.29|||||TWO_SIDED|90.0|84.38|98.76|||||"The estimated parameter was the adjusted geometric mean ratios (%) of BI 695501: (40 mg/0.4 mL (T))/(40 mg/0.8 mL (R)).~Geometric standard error= 104.874."|The statistical model used for the analysis of the primary endpoints was an analysis of covariance (ANCOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANCOVA model. This model included effects accounting for the following sources of variation: 'treatment', 'location of trial medication injection' and 'baseline body weight' (continuous).||98.76|84.38|
71776857|NCT05021081|143052936|OTHER|The least-square means (i.e., adjusted means) of photopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.7|-0.21|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean photopic contrast sensitivity with and without the glare source.||-0.21|-0.70|
71890871|NCT03093402|143303445|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.607|TWO_SIDED|95.0|-3.22|6.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Sleep Disturbance T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -3.5 (-6.8, -0.3).|Each active JBT-101 cohort is compared to placebo.||6.09|-3.22|0.607
71664240|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.033|TWO_SIDED|95.0|-0.69|-0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.03|-0.69|0.033
71664241|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.31||||0.062|TWO_SIDED|95.0|-0.64|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.02|-0.64|0.062
71664242|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.43||||0.011|TWO_SIDED|95.0|-0.76|-0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||-0.10|-0.76|0.011
71664243|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.027|TWO_SIDED|95.0|-0.7|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||-0.04|-0.70|0.027
71664244|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.37||||0.029|TWO_SIDED|95.0|-0.71|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||-0.04|-0.71|0.029
71664245|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.022|TWO_SIDED|95.0|-0.74|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.06|-0.74|0.022
71834252|NCT00976495|143172246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.3613|||TWO_SIDED|95.0|-7.11|2.31|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||2.31|-7.11|
71664246|NCT00261443|142841882|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.4||||0.023|TWO_SIDED|95.0|-0.75|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||-0.06|-0.75|0.023
71664247|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.09||||0.486|TWO_SIDED|95.0|-0.17|0.36||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.36|-0.17|0.486
71664248|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.04||||0.793|TWO_SIDED|95.0|-0.3|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.23|-0.30|0.793
71664249|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.665|TWO_SIDED|95.0|-0.34|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.22|-0.34|0.665
71664250|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.65|TWO_SIDED|95.0|-0.35|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.22|-0.35|0.650
71664251|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.06||||0.705|TWO_SIDED|95.0|-0.34|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.23|-0.34|0.705
71834253|NCT00976495|143172246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.4112|||TWO_SIDED|95.0|-1.55|8.08|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||8.08|-1.55|
71742237|NCT00286429|142996159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.556|TWO_SIDED|95.0|-0.8|0.43||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.43|-0.80|0.556
71742238|NCT00286429|142996160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.586|TWO_SIDED|95.0|-0.81|0.46||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.46|-0.81|0.586
71742239|NCT00286429|142996160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.404|TWO_SIDED|95.0|-0.91|0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.37|-0.91|0.404
71742240|NCT00286429|142996161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.874|TWO_SIDED|95.0|-0.62|0.72||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.72|-0.62|0.874
71742241|NCT00286429|142996161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.948|TWO_SIDED|95.0|-0.7|0.65||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.||0.65|-0.70|0.948
71742242|NCT00595478|142996162|SUPERIORITY||Odds Ratio (OR)|0.8||||0.66|TWO_SIDED|95.0|0.29|2.18|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0 ETG-positive samples for MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.18|0.29|0.66
71742243|NCT00595478|142996162|SUPERIORITY||mean ratio|0.93||||0.61|TWO_SIDED|95.0|0.71|1.22|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for number of ETG-positive samples, if \>0 ETG-positive samples: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||1.22|0.71|0.61
71742244|NCT00595478|142996163|SUPERIORITY||Odds Ratio (OR)|0.82||||0.74|TWO_SIDED|95.0|0.26|2.62|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0% days using alcohol during the 36 week follow-up period: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||2.62|0.26|0.74
71742245|NCT00595478|142996163|SUPERIORITY||mean ratio|0.74||||0.007|TWO_SIDED|95.0|0.59|0.92|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)|||.92|.59|0.007
71742246|NCT03691571|142996177|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||Esophageal thermal injury was detected in 13/44 (30%) patients.||||>.05
71742247|NCT03691571|142996179|OTHER|feasibility/pilot study||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71742248|NCT03691571|142996180|OTHER|feasibility/pilot study||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71742249|NCT03691571|142996181|OTHER|feasibility/pilot study||||||0.1|||||||Fisher Exact|||||||0.10
71742250|NCT00186901|142996186|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.86||95.0|||||Wilcoxon Test|||Baseline where N=134||||0.86
71742251|NCT00186901|142996186|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.17||||0.99||95.0|||||Wilcoxon Test|||12 Month BMD Z-Score Calculation where N=109||||0.99
71742252|NCT00186901|142996186|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.54||95.0|||||Wilcoxon Test|||24 Month BMD Z-Score calculation where N=91||||0.54
71742253|NCT00186901|142996186|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.31||95.0|||||Wilcoxon Test|||36 Month (End of Study) BMD Z-Score calculation where N=84||||0.31
71742254|NCT00186901|142996187|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.32||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
71742255|NCT00186901|142996188|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69||||0.0023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0023
71742256|NCT00186901|142996189|SUPERIORITY_OR_OTHER|||||||0.0092||95.0|||||Kruskal-Wallis|||||||0.0092
71834254|NCT00976495|143172247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.5072|||TWO_SIDED|95.0|-9.38|0.63|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||0.63|-9.38|
71834255|NCT00976495|143172247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|2.5474|||TWO_SIDED|95.0|-4.18|5.99|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.99|-4.18|
71834256|NCT00976495|143172248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|2.7812|||TWO_SIDED|95.0|-5.39|5.71|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||5.71|-5.39|
71742257|NCT00186901|142996190|SUPERIORITY_OR_OTHER||Correlation coefficient|0.41|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Z-test|||275 received a QCT and 121 received a DXA scan. 121 paired scans were evaluated.||0.55|0.25|<0.0001
71742258|NCT00186901|142996191|SUPERIORITY_OR_OTHER||Correlation coefficient|0.54|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Z-test|||218 patients were assessed at 12 months and received a QCT Scan. 94 patients were also assessed using the DEXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation coefficient.||0.67|0.38|<0.0001
71742259|NCT00186901|142996192|SUPERIORITY_OR_OTHER||Correlation coefficient|0.53|||<|0.0001|TWO_SIDED|95.0|0.36|0.66|||Z-test|||188 patients were assessed at baseline and received a QCT Scan. 90 patients were also assessed using the DEXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation coefficient.||0.66|0.36|<0.0001
71742260|NCT00186901|142996193|SUPERIORITY_OR_OTHER||Correlation coefficient|0.48|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||Z-test|||180 patients were assessed at 36 months and received a QCT Scan. 89 patients were also assessed using the DXA Scan. Comparison of the two methods used 89 paired studies to arrive at a correlation coefficient.||0.63|0.30|<0.0001
71742261|NCT00186901|142996194|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Kruskal Wallis|||||||0.40
71742262|NCT00186901|142996195|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal Wallis|||||||0.21
71742263|NCT00291486|142996232|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|||Comparison of CL between initial infusion and therapy infusion||||0.144
71742264|NCT00291486|142996233|SUPERIORITY|||||||0.361|||||||ANOVA|||||||0.361
71742265|NCT01099397|142996246|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value at baseline|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
71742266|NCT01099397|142996246|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value at 9 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.59
71776858|NCT05021081|143052937|OTHER|The least-square means (i.e., adjusted means) of mesopic contrast sensitivity at 6 cpd was estimated separately under conditions with glare source and without glare source. This endpoint was not statistically tested, and consequentially statistical interferences was not made.|Least-square Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|-0.81|-0.36|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as With glare minus Without glare|The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean mesopic contrast sensitivity with and without the glare source.||-0.36|-0.81|
71776859|NCT05021081|143052938|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% confidence interval of the mean difference was below 0.|Least-square Mean Difference|0.019|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.029|0.068|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as Test minus Control|Given no historical data is available, the sample size was not determined based on any empirical sample size calculation. A power analysis was conducted using a paired sample t-test (exact method) with a 2-sided type I error rate 0.05 to estimate statistical power based on different assumptions. The power analysis showed that the statistical power for testing superiority would be approximately 80% or higher with the effect size of -0.05 (mean difference: Test minus Control).||0.068|-0.029|
71776860|NCT00369122|143052941|OTHER||||||||||||||||||Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate \>=20% and AE rate \>=55% excessive. If there were \>=6 pts with SAES or \>=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.|||
71776861|NCT02651467|143052945|SUPERIORITY_OR_OTHER||Difference of Least Square mean|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.181|-0.584||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett's multiplicity adjustment is applied.||-0.584|-1.181|<0.0001
71776862|NCT02651467|143052945|SUPERIORITY_OR_OTHER||Diference of Least Square mean|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.333|-0.738||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the control, Dunnett's multiplicity adjustment is applied.||-0.738|-1.333|<0.0001
71776863|NCT02651467|143052946|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.15||||0.2478||95.0|-0.107|0.413||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.413|-0.107|0.2478
71776864|NCT02024529|143052953|SUPERIORITY|||||||0.97||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.97
71776865|NCT02024529|143052954|SUPERIORITY|||||||0.75||||||Adjusted for baseline WOMAC score|ANCOVA|||||||0.75
71776866|NCT02024529|143052955|SUPERIORITY|||||||0.18|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.18
71834257|NCT00976495|143172248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.31|STANDARD_ERROR_OF_MEAN|2.8135|||TWO_SIDED|95.0|1.7|12.93|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.|||12.93|1.70|
71664252|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.08||||0.572|TWO_SIDED|95.0|-0.38|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.21|-0.38|0.572
71664253|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.418|TWO_SIDED|95.0|-0.43|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||0.18|-0.43|0.418
71664254|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.2||||0.185|TWO_SIDED|95.0|-0.51|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.10|-0.51|0.185
71664255|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.1||||0.536|TWO_SIDED|95.0|-0.41|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.21|-0.41|0.536
71742267|NCT01099397|142996246|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||P-value at 18 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p\<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)||||0.41
71742268|NCT02363959|142996247|OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
71742269|NCT02363959|142996248|OTHER|||||||0.39|||||||Fisher Exact|||||||0.39
71742270|NCT02363959|142996249|OTHER|||||||1|||||||Fisher Exact|||||||1
71742271|NCT02363959|142996250|OTHER|||||||1|||||||Fisher Exact|||||||1
71664256|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.637|TWO_SIDED|95.0|-0.39|0.24||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.24|-0.39|0.637
71664257|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.34|0.29||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.29|-0.34|0.875
71664258|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.14||||0.378|TWO_SIDED|95.0|-0.46|0.17||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||0.17|-0.46|0.378
71664259|NCT00261443|142841884|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.12||||0.474|TWO_SIDED|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.20|-0.43|0.474
71664260|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.488|TWO_SIDED|95.0|-0.19|0.4||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison||0.40|-0.19|0.488
71742272|NCT02363959|142996251|OTHER|||||||1|||||||Fisher Exact|||||||1
71742273|NCT02363959|142996252|OTHER|||||||1|||||||Fisher Exact|||||||1
71742274|NCT02267538|142996281|OTHER||Odds Ratio (OR)|0.62||||0.341|TWO_SIDED|95.0|0.23|1.65|||Regression, Logistic|||||1.65|0.23|0.341
71742275|NCT02267538|142996282|OTHER||Median Difference (Final Values)|0.0||||0.83|TWO_SIDED|||||MMSE|Wilcoxon (Mann-Whitney)|||||||0.830
71742276|NCT02267538|142996282|OTHER||Median Difference (Final Values)|0.0||||0.405|TWO_SIDED|||||m-TICS|Wilcoxon (Mann-Whitney)|||||||0.405
71742277|NCT02267538|142996283|OTHER||Odds Ratio (OR)|0.74||||0.214|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||Incidence of total non-delirium complications within 30 days after surgery||1.19|0.47|0.214
71742278|NCT02267538|142996283|OTHER|stroke|Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08|||Regression, Logistic|||Incidence of stroke within 30 days after surgery||5.08|0.20|0.993
71742279|NCT02267538|142996283|OTHER|New onset arrythmia|Odds Ratio (OR)|0.76||||0.274|TWO_SIDED|95.0|0.46|1.25|||Regression, Logistic|||||1.25|0.46|0.274
71776867|NCT02024529|143052956|SUPERIORITY|||||||0.81|||||||ANCOVA|Adjusted for baseline WOMAC Score.||||||0.81
71664261|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.15||||0.349|TWO_SIDED|95.0|-0.46|0.16||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison||0.16|-0.46|0.349
71664262|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.07||||0.653|TWO_SIDED|95.0|-0.39|0.25||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison||0.25|-0.39|0.653
71664263|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.24||||0.141|TWO_SIDED|95.0|-0.56|0.08||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison||0.08|-0.56|0.141
71664264|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.22||||0.196|TWO_SIDED|95.0|-0.54|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison||0.11|-0.54|0.196
71664265|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.088|TWO_SIDED|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison||0.04|-0.62|0.088
71742280|NCT02267538|142996283|OTHER|Pulmonary complications|Odds Ratio (OR)|0.51||||0.05|TWO_SIDED|95.0|0.26|1.0|||Regression, Logistic|||||1.00|0.26|0.050
71742281|NCT02267538|142996283|OTHER||Odds Ratio (OR)|0.5||||0.423|TWO_SIDED|95.0|0.09|2.75||Upper gastrointestinal bleeding|Regression, Logistic|||||2.75|0.09|0.423
71742282|NCT02267538|142996283|OTHER||Odds Ratio (OR)|1.01||||0.993|TWO_SIDED|95.0|0.2|5.08||Surgical bleeding|Regression, Logistic|||||5.08|0.20|0.993
71742283|NCT02267538|142996283|OTHER||Odds Ratio (OR)|1.63||||0.326|TWO_SIDED|95.0|0.61|4.34||Wound dehiscence or infection|Regression, Logistic|||||4.34|0.61|0.326
71742284|NCT02267538|142996283|OTHER||Odds Ratio (OR)|0.79||||0.378|TWO_SIDED|95.0|0.47|1.33||Acute kidney injur|Regression, Logistic|||||1.33|0.47|0.378
71742285|NCT02267538|142996283|OTHER||Odds Ratio (OR)|0.48||||0.156|TWO_SIDED|95.0|0.18|1.32||IABP assistance|Regression, Logistic|||||1.32|0.18|0.156
71742286|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.596|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL group||0|-1|0.596
71742287|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.743|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL group||0|-1|0.743
71742288|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.282|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group||0|-1|0.282
71742289|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.368|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group||0|0|0.368
71742290|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.397|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group||0|0|0.397
71742291|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.486|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.486
71776868|NCT01426438|143052957|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.28
71776869|NCT01426438|143052957|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.||||||0.19
71742292|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.414
71742293|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.187|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.187
71742294|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.127|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group||0|-1|0.127
71890872|NCT03093402|143303446|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.981|TWO_SIDED|95.0|-4.66|4.3||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.30|-4.66|0.981
71664266|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.34||||0.047|TWO_SIDED|95.0|-0.68|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison||-0.01|-0.68|0.047
71664267|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.057|TWO_SIDED|95.0|-0.67|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison||0.01|-0.67|0.057
71742295|NCT02267538|142996284|OTHER||Median Difference (Final Values)|0.0||||0.378|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group||0|0|0.378
71742296|NCT02267538|142996285|OTHER||Median Difference (Final Values)|0.0||||0.777|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL group||0|0|0.777
71776870|NCT00676338|143052975|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.62|TWO_SIDED|98.3|-0.26|0.17||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.17|-0.26|0.620
71776871|NCT00676338|143052975|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.328|TWO_SIDED|98.3|-0.15|0.35||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||0.35|-0.15|0.328
71776872|NCT00676338|143052975|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|98.3|-0.62|-0.13||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.13|-0.62|<.001
71776873|NCT00676338|143052976|SUPERIORITY_OR_OTHER|||||||0.151|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.151
71776874|NCT00676338|143052976|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||0.913
71776875|NCT00676338|143052976|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple adjustment were done.|Fisher Exact|||||||<.001
71776876|NCT00676338|143052977|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.155|TWO_SIDED|95.0|-0.66|0.1||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.10|-0.66|0.155
71742297|NCT02267538|142996285|OTHER||Median Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL group||1|-1|0.919
71742298|NCT02267538|142996285|OTHER||Median Difference (Final Values)|0.0||||0.835|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group||0|0|0.835
71742299|NCT02267538|142996285|OTHER||Median Difference (Final Values)|0.0||||0.321|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group||0|0|0.321
71742300|NCT02267538|142996285|OTHER||Median Difference (Final Values)|0.0||||0.174|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group||0|0|0.174
71742301|NCT02267538|142996286|OTHER||Hazard Ratio (HR)|1.03||||0.788|TWO_SIDED|95.0|0.82|1.31|||Log Rank|||||1.31|0.82|0.788
71742302|NCT02267538|142996287|OTHER||Hazard Ratio (HR)|0.97||||0.826|TWO_SIDED|95.0|0.77|1.23|||Log Rank|||||1.23|0.77|0.826
71742303|NCT03152591|142996332|OTHER||Ratio LIK066/Placebo|0.88||||0.353|TWO_SIDED|90.0|0.7|1.11|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline in average fasting free testosterone was analyzed using an analysis of covariance model which included treatment as a categorical factor, baseline body weight and log transformed baseline average fasting free testosterone as a covariate.|1.11|0.70|0.353
71742304|NCT03152591|142996333|OTHER||Ratio LIK066/Placebo|1.25||||0.218|TWO_SIDED|90.0|0.92|1.68|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.68|0.92|0.218
71742305|NCT03152591|142996334|OTHER||Ratio LIK066/Placebo|1.27||||0.249|TWO_SIDED|90.0|0.9|1.78|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.78|0.90|0.249
71742306|NCT03152591|142996335|OTHER||Ratio LIK066/Placebo|1.15||||0.173|TWO_SIDED|90.0|0.97|1.36|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.36|0.97|0.173
71742307|NCT03152591|142996336|OTHER||Ratio LIK066/Placebo|0.82||||0.089|TWO_SIDED|90.0|0.68|0.99|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.99|0.68|0.089
71742308|NCT03152591|142996337|OTHER||Ration LIK066/Placebo|0.69||||0.109|TWO_SIDED|90.0|0.48|1.01|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.01|0.48|0.109
71742309|NCT03152591|142996338|OTHER||Ration LIK066/Placebo|0.76||||0.008|TWO_SIDED|90.0|0.65|0.89|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|0.89|0.65|0.008
71742310|NCT03152591|142996339|OTHER||Ratio LIK066/Placebo|0.91||||0.34|TWO_SIDED|90.0|0.77|1.07|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.07|0.77|0.340
71742311|NCT03152591|142996340|OTHER||Ratio LIK066/Placebo|0.79||||0.204|TWO_SIDED|90.0|0.58|1.08|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values \< LLOQ and values \> ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.|1.08|0.58|0.204
71742312|NCT02871635|142996366|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|90.0|0.87|1.028|||||BI 695501 as numerator Humira EU as denominator|Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.028|0.870|
71742313|NCT02871635|142996366|OTHER||Risk Ratio (RR)|0.945|||||TWO_SIDED|95.0|0.856|1.044|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.044|0.856|
71742314|NCT02871635|142996367|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|90.0|0.871|1.148|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.148|0.871|
71742315|NCT02871635|142996367|OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.848|1.178|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.178|0.848|
71742316|NCT02871635|142996368|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|90.0|0.751|1.078|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.078|0.751|
71742317|NCT02871635|142996368|OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.725|1.116|||||BI 695501 as numerator Humira EU as denominator|Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)||1.116|0.725|
71742318|NCT00412893|142996401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The upper bound of the 95% CI for the treatment difference was compared to the protocol prespecified non-inferiority margin of 10%. If the upper bound was smaller than 10%, isavuconazole was declared as non-inferior to voriconazole with respect to the primary outcome measure.|Adjusted Treatment Difference|-1.0|||||TWO_SIDED|95.0|-7.759|5.683|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Approximately 255 patients per group were to be enrolled to ensure at least 80% power to demonstrate that the upper bound of the 95% confidence interval (CI) for a treatment difference in favor of the comparator was no larger than 10%.||5.683|-7.759|
71742319|NCT00412893|142996402|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-9.336|12.572|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||12.572|-9.336|
71742320|NCT00412893|142996402|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.5|||||TWO_SIDED|95.0|-11.277|10.329|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.329|-11.277|
71742321|NCT00412893|142996402|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.2|||||TWO_SIDED|95.0|-1.993|18.379|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||18.379|-1.993|
71742322|NCT00412893|142996403|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-9.15|6.34|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|||6.340|-9.150|
71742323|NCT00412893|142996405|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.4|||||TWO_SIDED|95.0|-10.64|11.531|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment Comparison||11.531|-10.640|
71742324|NCT00412893|142996405|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-5.8|||||TWO_SIDED|95.0|-17.368|5.802|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||5.802|-17.368|
71742325|NCT00412893|142996405|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|0.3|||||TWO_SIDED|95.0|-11.116|11.758|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||11.758|-11.116|
71742326|NCT00412893|142996406|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|3.8|||||TWO_SIDED|95.0|-7.429|15.087|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||15.087|-7.429|
71742327|NCT00412893|142996406|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-0.7|||||TWO_SIDED|95.0|-11.917|10.586|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 Comparison||10.586|-11.917|
71742328|NCT00412893|142996406|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.1|||||TWO_SIDED|95.0|-1.624|19.83|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 Comparison||19.830|-1.624|
71776877|NCT00676338|143052977|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.22||0.153|TWO_SIDED|95.0|-0.12|0.75||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.75|-0.12|0.153
71776878|NCT00676338|143052977|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|-1.56|-0.68||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.68|-1.56|<.001
71742329|NCT00412893|142996407|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.7|||||TWO_SIDED|95.0|-4.936|16.268|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.268|-4.936|
71742330|NCT00412893|142996407|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.3|||||TWO_SIDED|95.0|-5.338|16.032|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||16.032|-5.338|
71742331|NCT00412893|142996407|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|9.0|||||TWO_SIDED|95.0|-1.231|19.186|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||19.186|-1.231|
71776879|NCT00676338|143052978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.892|TWO_SIDED|95.0|-0.61|0.53||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.53|-0.61|0.892
71742332|NCT00412893|142996408|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.0|||||TWO_SIDED|95.0|-6.043|16.026|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||16.026|-6.043|
71742333|NCT00412893|142996408|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|0.2|||||TWO_SIDED|95.0|-10.873|11.22|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||11.220|-10.873|
71742334|NCT00412893|142996408|SUPERIORITY_OR_OTHER_LEGACY||Adjusted treatment Difference|4.7|||||TWO_SIDED|95.0|-6.533|15.939|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||15.939|-6.533|
71742335|NCT00412893|142996409|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|4.4|||||TWO_SIDED|95.0|-8.429|17.218|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.218|-8.429|
71742336|NCT00412893|142996409|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|-2.5|||||TWO_SIDED|95.0|-15.071|10.073|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||10.073|-15.071|
71742337|NCT00412893|142996409|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|2.9|||||TWO_SIDED|95.0|-8.633|14.499|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||14.499|-8.633|
71776880|NCT00676338|143052978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.56|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-4.21|-2.9||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-2.90|-4.21|<.001
71776881|NCT00676338|143052978|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.92|-0.63||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.63|-1.92|<.001
71776882|NCT00676338|143052979|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.08||0.873|TWO_SIDED|95.0|-0.18|0.15||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.15|-0.18|0.873
71742338|NCT00412893|142996410|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|6.3|||||TWO_SIDED|95.0|-5.145|17.696|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison||17.696|-5.145|
71742339|NCT00412893|142996410|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|8.0|||||TWO_SIDED|95.0|-3.335|19.356|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison||19.356|-3.335|
71742340|NCT00412893|142996410|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Treatment Difference|5.1|||||TWO_SIDED|95.0|-6.187|16.332|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison||16.332|-6.187|
71742341|NCT00853151|142996412|SUPERIORITY_OR_OTHER|||||||0.623||90.0||||p-value is for LY2428757 plus TT223 3 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.623
71742342|NCT00853151|142996412|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||p-value is for LY2428757 plus TT223 2 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.||||||0.809
71742343|NCT04473963|142996467|NON_INFERIORITY|Non-inferiority between subjects Randomized to Treatment vs subjects Randomized to Control||||||0.277|||||||Chi-squared|||||||0.277
71742344|NCT04473963|142996469|EQUIVALENCE|"Equivalence between subjects Randomized to Control and subjects Randomized to Treatment"||||||0.042|||||||Kaplan-Meyer Log Rank|||||||0.042
71742345|NCT04473963|142996474|EQUIVALENCE|"Equivalence between procedure time of subjects Randomized to Treatment and subjects Randomized to Control. The Not-Randomized group was not included in the analysis."|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71742346|NCT01426958|142996496|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|119.3|STANDARD_DEVIATION|11.5||0.1009|TWO_SIDED|90.0|112.239|126.811||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||126.811|112.239|0.1009
71742347|NCT01426958|142996496|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.23|STANDARD_DEVIATION|10.9||0.0009|TWO_SIDED|90.0|103.837|117.006||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||117.006|103.837|0.0009
71742348|NCT01426958|142996496|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|91.9|STANDARD_DEVIATION|11.6||0.0004|TWO_SIDED|90.0|86.519|97.614||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||97.614|86.519|0.0004
71776883|NCT00676338|143052979|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.14|-0.52|<.001
71776884|NCT00676338|143052979|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.41|-0.03||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.03|-0.41|0.022
71776885|NCT00676338|143052980|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.004|TWO_SIDED|95.0|-0.09|-0.02||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.02|-0.09|0.004
71776886|NCT00676338|143052980|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.19|-0.11||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||-0.11|-0.19|<.001
71776887|NCT00676338|143052980|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.142|TWO_SIDED|95.0|-0.07|0.01||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.01|-0.07|0.142
71776888|NCT00676338|143052981|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.04||0.657|TWO_SIDED|95.0|0.94|1.1||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.10|0.94|0.657
71776889|NCT00676338|143052981|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|1.06|1.27||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.27|1.06|0.002
71776890|NCT00676338|143052981|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.04|STANDARD_ERROR_OF_MEAN|0.05||0.398|TWO_SIDED|95.0|0.95|1.14||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.||1.14|0.95|0.398
71834258|NCT02382744|143172295|SUPERIORITY_OR_OTHER||Difference between proportions (%)|10.0||||0.25|TWO_SIDED|95.0|-11.9|31.9||One-sided P-value based on the lack of plausibility that additional nerve stimulation would worsen sensory blockade rates.|Fisher Exact|||We sought to detect an increase in the rate of complete absence of sensation to pinprick 30 min following ultrasound-guided subsartorial saphenous nerve blockade to 90% from an assumed baseline of 64% as extrapolated from our previous study (cf. Head SJ et al. 2015) at β = 0.2. The required minimum sample size at α = 0.05 (one-sided) was 30 patients in each group. To be conservative, we aimed to enroll a total of 80 patients.||31.9|-11.9|0.25
71834259|NCT02382744|143172296|SUPERIORITY_OR_OTHER|||||||0.62||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.62
71834260|NCT02382744|143172297|SUPERIORITY_OR_OTHER|||||||0.62|||||||Fisher Exact|||||||0.62
71776891|NCT00676338|143052984|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.09||0.201|TWO_SIDED|95.0|-3.52|0.74||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||0.74|-3.52|0.201
71776892|NCT00676338|143052984|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.24||0.693|TWO_SIDED|95.0|-1.94|2.93||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.93|-1.94|0.693
71776893|NCT00676338|143052984|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.22||0.646|TWO_SIDED|95.0|-1.84|2.96||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||2.96|-1.84|0.646
71834261|NCT02382744|143172298|SUPERIORITY_OR_OTHER|||||||0.26||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, incomplete block at 30 minutes post nerve block versus no incomplete block at 30 minutes post nerve block."||||0.26
71834262|NCT02382744|143172299|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.7||||0.12|TWO_SIDED|95.0|0.38|1.31|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|"To assess speed of onset, sensation to pinprick in the distribution of the saphenous nerve was assessed for each patient every 5 min until complete sensory loss was noted, or until 30 min had elapsed. To compare the two groups in speed of onset on the basis of these data, we constructed Kaplan-Meyer survival curves for the times to onset of sensory blockade and compared the underlying time-to-event data with the log-rank test."||1.31|0.38|0.12
71834263|NCT02382744|143172303|SUPERIORITY_OR_OTHER||Difference between means (s)|107.0|||<|0.0001|TWO_SIDED|95.0|61.0|153.0|||t-test, 2 sided|||||153|61|<0.0001
71834264|NCT02382744|143172306|SUPERIORITY_OR_OTHER||"Median survival ratio"|0.58||||0.02|TWO_SIDED|95.0|0.37|0.93|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|||0.93|0.37|0.02
71742349|NCT01426958|142996497|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|104.06|STANDARD_DEVIATION|14.2||0.0002|TWO_SIDED|90.0|96.681|112.002||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||112.002|96.681|0.0002
71742350|NCT01426958|142996497|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|105.09|STANDARD_DEVIATION|16.1||0.0012|TWO_SIDED|90.0|96.425|114.53||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||114.530|96.425|0.0012
71742351|NCT01426958|142996497|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|99.75|STANDARD_DEVIATION|12.8||0|TWO_SIDED|90.0|93.328|106.61||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||106.610|93.328|0.0000
71776894|NCT00676338|143052985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.7||0.61|TWO_SIDED|95.0|-1.02|1.73||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.73|-1.02|0.610
71776895|NCT00676338|143052985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.8||0.013|TWO_SIDED|95.0|0.43|3.58||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||3.58|0.43|0.013
71776896|NCT00676338|143052985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.79||0.946|TWO_SIDED|95.0|-1.6|1.49||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.||1.49|-1.60|0.946
71776897|NCT02122458|143052986|SUPERIORITY||Mean Difference (Net)|0.448||||0.05|TWO_SIDED|95.0|-8.66|9.56||Given the preliminary nature of this treatment study and the small number of participants the p-value was not adjusted for multiple comparisons.|Mixed Models Analysis|An Adjusted Rank Transform was applied to the data prior to applying the mixed model analyses.||The null hypothesis evaluated by the HHIA was that self-perceived hearing handicap would not reduce from baseline to 6-months post-fitting.||9.56|-8.66|.05
71776898|NCT02122458|143052987|SUPERIORITY|||||||0.05||||||Given the small sample size and the preliminary nature of this study, the p-value was not adjusted for multiple comparisons.|ANOVA|||||||.05
71776899|NCT03161093|143052996|SUPERIORITY||Least Squares Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.18||0.0002|TWO_SIDED|95.0|-1.028|-0.324|||Mixed Models Analysis|||||-0.324|-1.028|0.0002
71776900|NCT03161093|143052997|SUPERIORITY||Least Squares Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.178|<|0.0001|TWO_SIDED|95.0|-1.046|-0.346|||Mixed Models Analysis|||||-0.346|-1.046|<0.0001
71776901|NCT03161093|143052998|SUPERIORITY||Least Squares Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.254||0.7036|TWO_SIDED|95.0|-0.594|0.401|||Mixed Models Analysis|||||0.401|-0.594|0.7036
71776902|NCT03161093|143052999|SUPERIORITY||Least Squares Mean|-0.18|STANDARD_ERROR_OF_MEAN|0.243||0.4605|TWO_SIDED|95.0|-0.657|0.297|||Mixed Models Analysis|||||0.297|-0.657|0.4605
71776903|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.12||||||Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.12|0.74|
71776904|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.98|0.70|
71776905|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.55|0.91||||||Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.91|0.55|
71776906|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.78|
71776907|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.85||||||Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.85|0.53|
71776908|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.08||||||Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.08|0.64|
71890873|NCT03093402|143303446|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.981|TWO_SIDED|95.0|-3.84|4.86||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.86|-3.84|0.981
71742352|NCT01426958|142996498|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|118.56|STANDARD_DEVIATION|11.5||0.0702|TWO_SIDED|90.0|111.712|125.822||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||125.822|111.712|0.0702
71742353|NCT01426958|142996498|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|110.76|STANDARD_DEVIATION|10.0||0.0005|TWO_SIDED|90.0|104.936|116.913||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||116.913|104.936|0.0005
71742354|NCT01426958|142996498|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.46|STANDARD_DEVIATION|11.9||0.0003|TWO_SIDED|90.0|86.928|98.341||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|||98.341|86.928|0.0003
71742355|NCT00991939|142996499|SUPERIORITY_OR_OTHER||Difference of proportions|0.0|STANDARD_ERROR_OF_MEAN|0.58||1|TWO_SIDED|95.0|-0.975|0.708|||Fisher Exact||The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.|Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.||0.708|-0.975|1.00
71776909|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.83|1.14||||||Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.83|
71742356|NCT00123123|142996540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0|||||ANOVA|||A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.||||0.6750
71742357|NCT02073682|142996544|NON_INFERIORITY|Edoxaban Group was considered non-inferior to the Dalteparin Group if the upper limit of the 2-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] Edoxaban Group to Dalteparin Group) was less than 1.5.|Cox Proportional Hazard|0.97||||0.0056|TWO_SIDED|95.0|0.696|1.359|||Cox proportional hazard|||||1.359|0.696|0.0056
71776910|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.0|0.69|
71776911|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.62|0.92||||||Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||0.92|0.62|
71776912|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.06||||||Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.06|0.64|
71742358|NCT02073682|142996544|SUPERIORITY|The hazard ratio (HR), two-sided confidence interval (CI) and p-value are based on the Cox proportional hazard model including treatment and the two stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||||||0.8712|||||||Cox proportional hazard|||||||0.8712
71742359|NCT02073682|142996545|SUPERIORITY||Hazard Ratio (HR)|2.0||||0.0254|TWO_SIDED|95.0|1.089|3.657|||Regression, Cox|||The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||3.657|1.089|0.0254
71742360|NCT02073682|142996546|SUPERIORITY||Cox Proportional Hazard|0.71||||0.0931|TWO_SIDED|95.0|0.476|1.059|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.059|0.476|0.0931
71742361|NCT02073682|142996547|SUPERIORITY||Cox Proportional Hazard|0.56||||0.0394|TWO_SIDED|95.0|0.318|0.972|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||0.972|0.318|0.0394
71742362|NCT02073682|142996548|SUPERIORITY||Cox Proportional Hazard|0.9||||0.7324|TWO_SIDED|95.0|0.502|1.624|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.624|0.502|0.7324
71742363|NCT02073682|142996549|SUPERIORITY||Cox Proportional Hazard|1.56||||0.4873|TWO_SIDED|95.0|0.444|5.505|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||5.505|0.444|0.4873
71742364|NCT02073682|142996550|SUPERIORITY||Cox Proportional Hazard|1.08||||0.4199|TWO_SIDED|95.0|0.898|1.293|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||1.293|0.898|0.4199
71742365|NCT00855816|142996558|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|||||A priori threshold for significance: p\<.05.|Mixed Models Analysis|Mixed model based on intent to treat sample.||Null hypothesis: there will be no differences in PTSD hyperarousal symptom changes in individuals who did receive the experimental intervention vs. those who did not .||||.27
71742366|NCT03393494|142996559|EQUIVALENCE|provides 85% power of success|Equivalence ratio|107.0|||||TWO_SIDED|90.0|97.8|112.2|||Fieller's method|||||112.2|97.8|
71776913|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.04|0.72|
71776914|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.14||||||Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.14|0.71|
71776915|NCT02124161|143053045|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.03||||||Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.03|0.56|
71776916|NCT02124161|143053046|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.18||||||Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.18|0.88|
71776917|NCT02124161|143053046|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.2|||||TWO_SIDED|95.0|1.01|1.32||||||Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.32|1.01|
71776918|NCT02124161|143053046|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.24||||||Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.24|0.95|
71776919|NCT02124161|143053046|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.21||||||Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).||1.21|0.90|
71776920|NCT02124161|143053049|SUPERIORITY_OR_OTHER||Percentage Difference|2.8|||||TWO_SIDED|95.0|-1.9|7.4||||||AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||7.4|-1.9|
71742367|NCT03393494|142996560|EQUIVALENCE|provides 85% power of success|Equivalence ratio|104.0||||0.05|TWO_SIDED|90.0|94.1|108.5|||Fieller's method|||||108.5|94.1|0.05
71742368|NCT01965704|142996561|OTHER|||||||0.2|||||||Fisher Exact|||||||0.2
71742369|NCT01965704|142996562|OTHER||Mean Difference (Final Values)|-1.9||||0.56|TWO_SIDED|95.0|-8.0|4.3|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in overall length of stay.||4.3|-8.0|0.56
71776921|NCT02124161|143053049|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.||1.7|-1.8|
71776922|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-2.8||||0.333|TWO_SIDED|95.0|-8.3|2.8|||Chan and Zhang method|||Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.8|-8.3|0.333
71742370|NCT01965704|142996562|OTHER||Median Difference (Final Values)|-1.9||||0.07|TWO_SIDED|95.0|-4.0|0.2|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|Difference in length of stay as calculated with maximum length capped at 15 days.||0.2|-4.0|0.07
71742371|NCT01965704|142996563|OTHER||Mean Difference (Final Values)|-1.8||||0.31|TWO_SIDED|95.0|-8.8|2.7|||Wilcoxon Rank-Sum test||The 95% confidence interval between the ondansetron group and the placebo group was calculated with the use of Hodges-Lehmann estimator.|||2.7|-8.8|0.31
71742372|NCT01526213|142996567|SUPERIORITY_OR_OTHER||Geometric Mean AUC Ratio (GFJ/mGFJ)|0.96||||0.78|TWO_SIDED|90.0|0.4|1.5|||t-test, 2 sided|||For juice comparisons, fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + grapefruit juice will be the reference standard (denominator).||1.5|0.4|0.78
71742373|NCT00413218|142996590|NON_INFERIORITY|The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.|Adjusted Treatment Difference (%)|-10.8|||||TWO_SIDED|95.0|-19.9|-1.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.||-1.8|-19.9|
71742374|NCT00413218|142996591|OTHER||Adjusted Treatment Difference (%)|-2.7|||||TWO_SIDED|95.0|-12.2|6.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||6.8|-12.2|
71776923|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-4.3||||0.105|TWO_SIDED|95.0|-9.6|0.9|||Chan and Zhang method|||Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.9|-9.6|0.105
71776924|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-3.5||||0.09|TWO_SIDED|95.0|-7.6|0.6|||Chan and Zhang method|||Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.6|-7.6|0.090
71742375|NCT00413218|142996592|OTHER||Adjusted Treatment Difference %|-10.9|||||TWO_SIDED|95.0|-19.9|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-19.9|
71742376|NCT00413218|142996592|OTHER||Adjusted Treatment Difference %|-5.4|||||TWO_SIDED|95.0|-15.0|4.2|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.2|-15.00|
71742377|NCT00413218|142996593|OTHER||Adjusted Treatment Difference (%)|-8.2|||||TWO_SIDED|95.0|-15.4|-0.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.9|-15.4|
71742378|NCT00413218|142996593|OTHER||Adjusted Treatment Difference (%)|-8.6|||||TWO_SIDED|95.0|-15.8|-1.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.5|-15.8|
71742379|NCT00413218|142996593|OTHER||Adjusted Treatment Difference (%)|-0.4|||||TWO_SIDED|95.0|-9.1|8.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||8.3|-9.1|
71776925|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|1.8||||0.59|TWO_SIDED|95.0|-4.2|7.8|||Chan and Zhang method|||Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||7.8|-4.2|0.590
71776926|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.044|TWO_SIDED|95.0|-7.5|-0.1|||Chan and Zhang method|||Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.1|-7.5|0.044
71776927|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-1.4||||0.574|TWO_SIDED|95.0|-6.2|3.4|||Chan and Zhang method|||Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.4|-6.2|0.574
71890874|NCT03093402|143303446|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.981|TWO_SIDED|95.0|-4.62|4.08||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Social Role Satisfaction T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 4.2 (0.8, 7.6).|||4.08|-4.62|0.981
71742380|NCT00413218|142996593|OTHER||Adjusted Treatment Difference (%)|-5.8|||||TWO_SIDED|95.0|-15.3|3.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||3.6|-15.3|
71742381|NCT00413218|142996594|OTHER||Adjusted Treatment Difference (%)|-14.9|||||TWO_SIDED|95.0|-22.7|-7.0|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-7.0|-22.7|
71742382|NCT00413218|142996594|OTHER||Adjusted Treatment Difference (%)|-15.9|||||TWO_SIDED|95.0|-23.5|-8.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-8.4|-23.5|
71742383|NCT00413218|142996594|OTHER||Adjusted Treatment Difference (%)|-0.7|||||TWO_SIDED|95.0|-8.1|9.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||9.6|-8.1|
71742384|NCT00413218|142996594|OTHER||Adjusted Treatment Difference (%)|-5.2|||||TWO_SIDED|95.0|-14.7|4.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||4.3|-14.7|
71742385|NCT00413218|142996595|OTHER||Adjusted Treatment Difference (%)|-11.4|||||TWO_SIDED|95.0|-20.4|-2.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-2.5|-20.4|
71776928|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-1.2||||0.648|TWO_SIDED|95.0|-6.3|3.9|||Chan and Zhang method|||Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||3.9|-6.3|0.648
71742386|NCT00413218|142996595|OTHER||Adjusted Treatment Difference (%)|-8.5|||||TWO_SIDED|95.0|-16.5|-0.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-0.4|-16.5|
71776929|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-6.2||||0.057|TWO_SIDED|95.0|-12.5|0.2|||Chan and Zhang method|||Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.2|-12.5|0.057
71776930|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-3.7||||0.03|TWO_SIDED|95.0|-7.3|-0.3|||Chan and Zhang method|||Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||-0.3|-7.3|0.030
71776931|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-2.5||||0.233|TWO_SIDED|95.0|-6.6|1.6|||Chan and Zhang method|||Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.6|-6.6|0.233
71776932|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-1.8||||0.152|TWO_SIDED|95.0|-4.5|0.7|||Chan and Zhang method|||Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||0.7|-4.5|0.152
71776933|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.926|TWO_SIDED|95.0|-5.1|5.8|||Chan and Zhang method|||Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||5.8|-5.1|0.926
71776934|NCT02124161|143053051|SUPERIORITY_OR_OTHER||Percentage Difference|-3.9||||0.143|TWO_SIDED|95.0|-9.1|1.3|||Chan and Zhang method|||Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||1.3|-9.1|0.143
71776935|NCT02124161|143053054|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|5.1||||0.094|TWO_SIDED|95.0|-0.9|11.0|||Chan and Zhang method|||Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||11.0|-0.9|0.094
71776936|NCT02124161|143053054|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-3.8||||0.232|TWO_SIDED|95.0|-9.9|2.4|||Chan and Zhang method|||Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||2.4|-9.9|0.232
71776937|NCT02124161|143053054|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.0||||0.734|TWO_SIDED|95.0|-6.6|4.5|||Chan and Zhang method|||Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.5|-6.6|0.734
71776938|NCT02124161|143053054|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.5||||0.627|TWO_SIDED|95.0|-7.2|4.3|||Chan and Zhang method|||Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.||4.3|-7.2|0.627
71776939|NCT01147640|143053082|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.4|||||TWO_SIDED|||||||||||||
71776940|NCT01147640|143053083|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|95.0||||||||||||
71776941|NCT00091442|143053087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5988||95.0|0.86|1.3||Not adjusted for multiple comparison.|Log Rank|||Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.||1.3|0.86|0.5988
71776942|NCT00091442|143053088|SUPERIORITY_OR_OTHER|||||||0.0085||95.0||||Not adjusted for multiple comparison|Cochran-Mantel-Haenszel|||Null hypothesis - no difference in response rate between the two treatment groups.||||0.0085
71776943|NCT00091442|143053089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001||95.0|0.55|0.77|||Log Rank|||"Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.~Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution."||0.77|0.55|<0.0001
71742387|NCT00413218|142996596|OTHER||Adjusted Treatment Difference (%)|-11.1|||||TWO_SIDED|95.0|-20.3|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||-1.9|-20.3|
71742388|NCT00413218|142996596|OTHER||Adjusted Treatment Difference (%)|-8.1|||||TWO_SIDED|95.0|-16.3|0.1|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.||0.1|-16.3|
71776944|NCT01950169|143053125|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
71776945|NCT01950169|143053126|SUPERIORITY|||||||0.05|||||||ANCOVA|Covariates used were age, sex, total mass, and baseline BMD. Data were reported using complete-cases analysis and intention-to-treat (ITT) analysis.||||||0.05
71776946|NCT01950169|143053127|SUPERIORITY|||||||0.05|||||||ANCOVA|The analyses included exposure measures treatment groups and sex as fixed factors. Age and baseline values for FFMI, FMI were included as covariates.||||||0.05
71776947|NCT01680887|143053182|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
71776948|NCT02664610|143053219|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
71776949|NCT02664610|143053220|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71742389|NCT00413218|142996597|OTHER||Adjusted Treatment Difference (%)|2.5|||||TWO_SIDED|95.0|-3.8|8.9||||||Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||8.9|-3.8|
71742390|NCT00413218|142996597|OTHER||Adjusted Treatment Difference (%)|1.4|||||TWO_SIDED|95.0|-7.1|10.0||||||Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.||10.0|-7.1|
71742391|NCT01687296|142996631|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.46||||0.931|TWO_SIDED|95.0|-9.85|10.76|||ANCOVA|||250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.||10.76|-9.85|0.931
71776950|NCT00464269|143053267|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|12.8|||=|0.025|TWO_SIDED|95.0|1.7|22.6|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.||22.6|1.7|=0.025
71776951|NCT00464269|143053267|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|4.1|||=|0.492|TWO_SIDED|95.0|-8.1|15.0|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.||15.0|-8.1|=0.492
71776952|NCT02337738|143053290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0006|TWO_SIDED|95.0|-1.32|-0.364|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).|||-0.364|-1.320|0.0006
71776953|NCT02337738|143053290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.07|-0.122|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 0.5mg and Placebo (TVP-1012 0.5mg - Placebo).|||-0.122|-1.070|0.0140
71776954|NCT00406354|143053301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-1.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.5|-5.0|<.001
71776955|NCT00406354|143053302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-3.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-3.8|-11.0|<.001
71776956|NCT00406354|143053303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-1.8|-5.3|<.001
71742392|NCT01687296|142996632|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.5||||0.922|TWO_SIDED|95.0|-9.64|10.65|||ANCOVA|||||10.65|-9.64|0.922
71742393|NCT01687296|142996633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.822|TWO_SIDED|95.0|-9.02|11.34|||ANCOVA|||||11.34|-9.02|0.822
71742394|NCT01687296|142996634|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for day-time symptom score||||0.717
71742395|NCT01687296|142996634|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for night-time symptom score||||0.683
71742396|NCT01687296|142996635|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||Wilcoxon rank sum test|||||||0.996
71742397|NCT01687296|142996636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.348|TWO_SIDED|95.0|-0.135|0.048|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 5||0.048|-0.135|0.348
71742398|NCT01687296|142996636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004||||0.914|TWO_SIDED|95.0|-0.074|0.083|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 8||0.083|-0.074|0.914
71742399|NCT01687296|142996636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.067||||0.276|TWO_SIDED|95.0|-0.187|0.054|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 5||0.054|-0.187|0.276
71742400|NCT01687296|142996636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.384|TWO_SIDED|95.0|-0.126|0.049|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 8||0.049|-0.126|0.384
71664268|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.063|TWO_SIDED|95.0|-0.68|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison||0.02|-0.68|0.063
71664269|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.3||||0.091|TWO_SIDED|95.0|-0.65|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison||0.05|-0.65|0.091
71664270|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.29||||0.105|TWO_SIDED|95.0|-0.64|0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison||0.06|-0.64|0.105
71742401|NCT01687296|142996637|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 5||||0.507
71742402|NCT01687296|142996637|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 8||||0.700
71742403|NCT01687296|142996638|SUPERIORITY_OR_OTHER|||||||0.633||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for participant/parent global evaluation||||0.633
71742404|NCT01687296|142996638|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for investigator global evaluation||||0.323
71742405|NCT00799903|142996655|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.199|TWO_SIDED|95.1|0.85|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.85|0.199
71776957|NCT00406354|143053304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.8|-2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-2.0|-5.8|<.001
71742406|NCT00799903|142996656|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.045|TWO_SIDED|95.0|0.82|1.0||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.00|0.82|0.045
71742407|NCT00799903|142996657|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.019|TWO_SIDED|95.0|0.84|0.98||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||0.98|0.84|0.019
71742408|NCT00799903|142996658|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.594|TWO_SIDED|95.0|0.83|1.11||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.11|0.83|0.594
71742409|NCT00799903|142996659|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.108|TWO_SIDED|95.0|0.77|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.03|0.77|0.108
71664271|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.36||||0.047|TWO_SIDED|95.0|-0.72|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison||-0.01|-0.72|0.047
71664272|NCT00261443|142841886|SUPERIORITY_OR_OTHER_LEGACY||Difference|-0.33||||0.073|TWO_SIDED|95.0|-0.69|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison||0.03|-0.69|0.073
71664273|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.0||||0.91|TWO_SIDED|95.0|0.92|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 4||1.08|0.92|0.910
71664274|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.04||||0.3|TWO_SIDED|95.0|0.97|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 8||1.11|0.97|0.300
71664275|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.01||||0.744|TWO_SIDED|95.0|0.95|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 12||1.08|0.95|0.744
71742410|NCT00799903|142996660|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.92|TWO_SIDED|95.0|0.81|1.27||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.27|0.81|0.920
71742411|NCT00799903|142996661|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.397|TWO_SIDED|95.0|0.88|1.05||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.05|0.88|0.397
71742412|NCT00799903|142996662|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.87|TWO_SIDED|95.0|0.9|1.13||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox|||||1.13|0.90|0.870
71742413|NCT02518971|142996663|OTHER|||||||0.345|||||||Chi-squared|||||||0.345
71776958|NCT00406354|143053305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.2|-0.6|<.001
71776959|NCT00406354|143053306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.4|-0.1||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.1|-0.4|0.006
71776960|NCT00406354|143053307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.2|-0.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.9|-6.2|0.010
71776961|NCT00406354|143053308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.01|TWO_SIDED|95.0|-3.2|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-3.2|0.010
71776962|NCT00406354|143053309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.406|TWO_SIDED|95.0|-4.9|2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Negative values are in favor of the atomoxetine arms.|||2.0|-4.9|0.406
71776963|NCT00406354|143053310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
71834265|NCT02382744|143172309|SUPERIORITY_OR_OTHER|||||||0.0057|||||||Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two arms, Patients with response to nerve stimulation and Patients with lack response to nerve stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."||||0.0057
71776964|NCT00406354|143053311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
71776965|NCT00406354|143053312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.|||-0.4|-1.1|<.001
71742414|NCT02518971|142996664|OTHER|||||||0.378|||||||Student T-Test|||||||.378
71742415|NCT02518971|142996665|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71742416|NCT02518971|142996666|OTHER|||||||0.497|||||||Fisher Exact|||||||.497
71742417|NCT02518971|142996667|OTHER|||||||0.207|||||||Student T-test|||||||.207
71742418|NCT02336230|142996669|OTHER|||||||0.0003||||||P-value was calculated from the binomial distribution under the assumption of a 0.45 success rate for the null hypothesis.|Binomial Distribution|||||||0.0003
71742419|NCT02336230|142996671|OTHER|||||||0.0032||||||P-value was from a Cochran-Mantel-Haenszel (CMH) test stratified by baseline aGVHD grade.|CHM test|||||||0.0032
71742420|NCT02524171|142996675|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.1|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71776966|NCT00406354|143053313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.2||0.021|TWO_SIDED|95.0|0.8|9.3||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||9.3|0.8|0.021
71776967|NCT00406354|143053314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.1||0.017|TWO_SIDED|95.0|-13.8|-1.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||-1.4|-13.8|0.017
71776968|NCT00406354|143053315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|2.8||0.05|TWO_SIDED|95.0|0.0|10.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||10.9|-0.0|0.050
71776969|NCT00406354|143053316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.9|16.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||16.4|4.9|<.001
71834266|NCT03087708|143172330|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
71834267|NCT03087708|143172330|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
71834268|NCT03087708|143172330|OTHER||||||<|0.6546|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<0.6546
71776970|NCT00406354|143053317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|3.3||0.015|TWO_SIDED|95.0|1.6|14.6||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||14.6|1.6|0.015
71776971|NCT00406354|143053318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|3.4||0.018|TWO_SIDED|95.0|1.4|14.7||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive results are in favor of the atomoxetine arms.|||14.7|1.4|0.018
71776972|NCT00406354|143053319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|3.3||0.138|TWO_SIDED|95.0|-1.6|11.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.|||11.5|-1.6|0.138
71776973|NCT00406354|143053320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.193||||0.016||95.0|1.16|4.146||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Log Rank|||||4.146|1.160|0.016
71776974|NCT00406354|143053321|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the initial three weeks of study treatment|Fisher Exact|||||||0.102
71776975|NCT00406354|143053322|SUPERIORITY_OR_OTHER|||||||0.101||95.0||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the nine-week study treatment period.|Fisher Exact|||||||0.101
71776976|NCT01498978|143053335|OTHER|Exact binomial test (two-sided).||||||0.754|||||||Exact Binomial Test|||Exact binomial test (two-sided). Null hypothesis: the proportion is equal to 0.5||||0.754
71776977|NCT01498978|143053336|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.19|||||||Fisher Exact|||||||0.190
71776978|NCT01498978|143053339|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.5|||||||Fisher Exact|||||||0.500
71776979|NCT01498978|143053340|OTHER|Test of association (contingency) between the two kinds of classification.||||||1|||||||Fisher Exact|||||||1.000
71776980|NCT01498978|143053341|OTHER|Test of association (contingency) between the two kinds of classification.||||||0.524|||||||Fisher Exact|||||||0.524
71834269|NCT03087708|143172330|OTHER||||||<|0.7051|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.7051
71664276|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.09||||0.015|TWO_SIDED|95.0|1.02|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 16||1.17|1.02|0.015
71664277|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.264|TWO_SIDED|95.0|0.97|1.14||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 20||1.14|0.97|0.264
71776981|NCT01033851|143053364|SUPERIORITY_OR_OTHER|||||||0.0366||95.0|||||ANOVA|||A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p\<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).||||0.0366
71776982|NCT01011738|143053369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.349||||0.0022|TWO_SIDED|95.0|1.542|7.271||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||7.271|1.542|0.0022
71776983|NCT01011738|143053369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.595||||0.0019|TWO_SIDED|95.0|1.603|8.063||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||8.063|1.603|0.0019
71776984|NCT01011738|143053369|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.851||||0.0369|TWO_SIDED|95.0|0.732|0.99||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Weight in kg was analyzed as independent predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.990|0.732|0.0369
71776985|NCT01011738|143053373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0033|TWO_SIDED|95.0|0.045|0.539||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||0.539|0.045|0.0033
71776986|NCT01011738|143053373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.191||||0.0042|TWO_SIDED|95.0|0.062|0.594|||Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.||0.594|0.062|0.0042
71834270|NCT03087708|143172330|OTHER||||||<|0.2262|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<0.2262
71834271|NCT03087708|143172330|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Hematologic 3+ vs Hematologic \<3||||<1
71834272|NCT03087708|143172330|OTHER||||||<|1|||||||Fisher Exact|||Comparison of Non-Hematologic 3+ vs Non-Hematologic \<3||||<1
71834273|NCT03087708|143172334|OTHER||||||<|0.68182|||||||Fisher Exact|||||||<0.68182
71834274|NCT03087708|143172334|OTHER||||||<|0.1091|||||||Fisher Exact|||||||<0.1091
71834275|NCT03087708|143172335|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||||||<1.0
71834276|NCT03087708|143172335|OTHER||||||<|0.3339|||||||Wilcoxon (Mann-Whitney)|||||||<0.3339
71664278|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.09|TWO_SIDED|95.0|0.99|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 24||1.11|0.99|0.090
71664279|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.08||||0.056|TWO_SIDED|95.0|1.0|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 28||1.17|1.00|0.056
71776987|NCT01011738|143053373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.528||||0.0149|TWO_SIDED|95.0|1.086|2.15||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, ALT ratio was analysed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.||2.150|1.086|0.0149
71834277|NCT03087708|143172336|OTHER||||||<|0.593|||||||Wilcoxon (Mann-Whitney)|||||||<0.5930
71664280|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|0.99||||0.756|TWO_SIDED|95.0|0.93|1.05||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 32||1.05|0.93|0.756
71664281|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.05||||0.177|TWO_SIDED|95.0|0.98|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 36||1.13|0.98|0.177
71664282|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.021|TWO_SIDED|95.0|1.01|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 40||1.13|1.01|0.021
71664283|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.216|TWO_SIDED|95.0|0.96|1.16||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 44||1.16|0.96|0.216
71664284|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.07||||0.017|TWO_SIDED|95.0|1.01|1.15||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 48||1.15|1.01|0.017
71664285|NCT00261443|142841887|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Remission Rate|1.06||||0.083|TWO_SIDED|95.0|0.99|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 52||1.13|0.99|0.083
71664286|NCT00261443|142841888|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78||||0.132|TWO_SIDED|95.0|0.56|1.08|||Stratified Log Rank Test|Stratified Log Rank Test p-value for equality of survival curves.||||1.08|0.56|0.132
71664287|NCT00261443|142841929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.640
71664288|NCT00261443|142841929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.423
71664289|NCT00261443|142841929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.297
71664290|NCT00261443|142841929|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.707
71664291|NCT00261443|142841930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.656
71664292|NCT00261443|142841930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.045
71664293|NCT00261443|142841930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.532
71664294|NCT00261443|142841930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.578
71664295|NCT00261443|142841931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.619
71664296|NCT00261443|142841931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.868
71664297|NCT00261443|142841931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.284
71664298|NCT00261443|142841931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.481||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.481
71664299|NCT00261443|142841932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.184
71664300|NCT00261443|142841932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.073
71664301|NCT00261443|142841932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.020
71664302|NCT00261443|142841932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.206
71664303|NCT00261443|142841933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.142
71664304|NCT00261443|142841933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.110
71834278|NCT03087708|143172336|OTHER||||||<|0.3105|||||||Wilcoxon (Mann-Whitney)|||||||<0.3105
71834279|NCT03087708|143172337|OTHER|||||||0.6024|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||0.6024
71664305|NCT00261443|142841933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.022
71834280|NCT03087708|143172337|OTHER||||||<|0.3116|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at Baseline||||<0.3116
71664306|NCT00261443|142841933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.542
71664307|NCT00261443|142841934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.916||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.916
71664308|NCT00261443|142841934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.707
71664309|NCT00261443|142841934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.665||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.665
71664310|NCT00261443|142841934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.757
71664311|NCT00261443|142841935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.871
71664312|NCT00261443|142841935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.362
71664313|NCT00261443|142841935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.295
71664314|NCT00261443|142841935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.519||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.519
71664315|NCT00261443|142841936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.935||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.935
71664316|NCT00261443|142841936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.174
71664317|NCT00261443|142841936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.527
71664318|NCT00261443|142841936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.753
71664319|NCT00261443|142841937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||95.0|||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo||||0.850
71664320|NCT00261443|142841937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.709||95.0|||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo||||0.709
71664321|NCT00261443|142841937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo||||0.326
71664322|NCT00261443|142841937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.201||95.0|||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo||||0.201
71664323|NCT00261443|142841938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47||||0.491|TWO_SIDED|95.0|-0.87|1.81||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 (LOCF) Treatment Difference||1.81|-0.87|0.491
71664324|NCT00261443|142841938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.945|TWO_SIDED|95.0|-1.21|1.12||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value Treatment Difference||1.12|-1.21|0.945
71664325|NCT00261443|142841939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.279
71664326|NCT00261443|142841939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.247||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.247
71664327|NCT00261443|142841939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.329
71664328|NCT00261443|142841939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.928||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.928
71664329|NCT00261443|142841939|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.17||||0.584|TWO_SIDED|95.0|0.66|2.09||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||2.09|0.66|0.584
71664330|NCT00261443|142841939|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.26||||0.369|TWO_SIDED|95.0|0.76|2.08||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||2.08|0.76|0.369
71664331|NCT00261443|142841940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison||||0.685
71664332|NCT00261443|142841940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison||||0.792
71664333|NCT00261443|142841940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison||||0.805
71664334|NCT00261443|142841940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison||||0.533
71834281|NCT03087708|143172337|OTHER||||||<|0.7712|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<0.7712
71834282|NCT03087708|143172337|OTHER||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Average Pain Scores at 6 Months||||<1.0
71834283|NCT03087708|143172338|OTHER||||||<|1|||||||Fisher Exact|||Analgesic Use at 6 Months||||<1.0000
71834284|NCT03087708|143172338|OTHER||||||<|0.5758|||||||Fisher Exact|||Analgesic Use at 6 Months||||<0.5758
71834285|NCT03087708|143172338|OTHER||||||<|1|||||||Fisher Exact|||Analgesic use at Baseline||||<1.0000
71834286|NCT03087708|143172338|OTHER|||||||0.593|||||||Fisher Exact|||Analgesic use at Baseline||||0.5930
71742421|NCT02524171|142996675|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.88|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742422|NCT02524171|142996676|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742423|NCT02524171|142996676|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742424|NCT02524171|142996677|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|10.98|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742425|NCT02524171|142996677|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|14.64|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71776988|NCT01163266|143053388|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|1.151||0.058|TWO_SIDED|95.0|-4.45|0.08||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.08|-4.45|0.058
71664335|NCT00261443|142841940|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.78||||0.545|TWO_SIDED|95.0|0.35|1.74||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison||1.74|0.35|0.545
71742426|NCT02524171|142996678|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.45|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews||||||>0.05
71742427|NCT02524171|142996678|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|1.22|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742428|NCT02524171|142996679|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742429|NCT02524171|142996679|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
71742430|NCT02524171|142996680|SUPERIORITY||Time x Condition at 6mo.(Beta value)|0.04|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742431|NCT02524171|142996680|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742432|NCT02524171|142996681|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71664336|NCT00261443|142841940|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.01||||0.987|TWO_SIDED|95.0|0.54|1.86||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"||1.86|0.54|0.987
71742433|NCT02524171|142996681|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||<0.05
71742434|NCT02524171|142996682|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
71742435|NCT02524171|142996682|SUPERIORITY||Time x Condition at 6 mo.(Beta value)|0.06|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742436|NCT02524171|142996683|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta|0.69|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742437|NCT02524171|142996683|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|-0.89|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742438|NCT02524171|142996684|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.07|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71776989|NCT01163266|143053388|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|1.161||0.002|TWO_SIDED|95.0|-5.92|-1.35||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.35|-5.92|0.002
71742439|NCT02524171|142996684|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63)||||>0.05
71742440|NCT02524171|142996685|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|6.53|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742441|NCT02524171|142996685|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|5.68|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63||||>0.05
71742442|NCT02524171|142996686|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.83|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742443|NCT02524171|142996686|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta v|0.46|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.01
71742444|NCT02524171|142996687|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|0.02|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742445|NCT02524171|142996687|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)|-0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
71742446|NCT02524171|142996688|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.03|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71742447|NCT02524171|142996688|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
71664337|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.646||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Treatment Comparison Baseline||||0.646
71664338|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 12 Treatment Comparison||||0.006
71664339|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 24 Treatment Comparison||||0.485
71664340|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 36 Treatment Comparison||||0.325
71742448|NCT02524171|142996689|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.01|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||>0.05
71776990|NCT01163266|143053389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.301|TWO_SIDED|95.0|0.796|2.093|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.093|0.796|0.301
71834287|NCT03725722|143172365|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with adjusted p-value of \<0.025 were stat. sign. diff. from a flat dose-response model.~Model selected: Sigmoid Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the change from baseline to Week 8 in EASI score and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) likely to present the true underlying dose-response curve.||||<0.0001
71664341|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 Treatment Comparison||||0.374
71664342|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 (LOCF) Treatment Comparison||||0.064
71776991|NCT01163266|143053389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.639||||0.044|TWO_SIDED|95.0|1.013|2.652||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||2.652|1.013|0.044
71776992|NCT01163266|143053390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.129||0.119|TWO_SIDED|95.0|-0.45|0.05|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.05|-0.45|0.119
71664343|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Highest Value Treatment Comparison||||0.310
71664344|NCT00261443|142841941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Lowest Value Treatment Comparison||||0.046
71664345|NCT00261443|142841943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.331||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALP||||0.331
71664346|NCT00261443|142841943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)||||0.353
71664347|NCT00261443|142841943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.298||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALP Highest Change Value During Phase 3||||0.298
71664348|NCT00261443|142841944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALT||||0.111
71664349|NCT00261443|142841944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in ALT at Week 52 (LOCF)||||0.948
71664350|NCT00261443|142841944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.559||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALT Highest Change Value During Phase 3||||0.559
71664351|NCT00261443|142841945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline AST||||0.077
71664352|NCT00261443|142841945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in AST at Week 52 (LOCF)||||0.255
71664353|NCT00261443|142841945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.918||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison AST Highest Change Value During Phase 3||||0.918
71664354|NCT00261443|142841946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline BUN||||0.118
71742449|NCT02524171|142996689|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|-0.08|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||<0.05
71742450|NCT02524171|142996690|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.07|||<|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||||||<0.05
71742451|NCT02524171|142996690|SUPERIORITY||Other[Time x Condition at 12 mo.(Beta)]|0.08|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Models adjusted for covariates (yielded estimated mean values of the outcome) and non-response weights based on completion of follow-up interviews.||Per protocol analysis, which included all UC participants (n=169) and only those in the MRT condition who had received the minimum recommended dose of the intervention - i.e., Step 3 or higher of MRT (n=63).||||>0.05
71742452|NCT00940901|142996691|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Null hypothesis: there would be no difference in the number of participants who experienced at least a 50% reduction in the frequency of priapic episodes between baseline and 8 weeks post intervention, between the sildenafil and placebo groups||||1
71742453|NCT00940901|142996692|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||||||0.55
71776993|NCT01163266|143053390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.129||0.024|TWO_SIDED|95.0|-0.55|-0.04|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.04|-0.55|0.024
71776994|NCT01163266|143053391|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29|STANDARD_ERROR_OF_MEAN|1.891||0.025|TWO_SIDED|95.0|-8.03|-0.56|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.||||-0.56|-8.03|0.025
71776995|NCT01163266|143053391|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.26|STANDARD_ERROR_OF_MEAN|1.852|<|0.001|TWO_SIDED|95.0|-10.92|-3.6|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-3.60|-10.92|<0.001
71776996|NCT01163266|143053392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.665||||0.093|TWO_SIDED|95.0|0.918|3.018|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.018|0.918|0.093
71742454|NCT00757237|142996693|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-7.8||||0.0001|TWO_SIDED|95.0|-11.73|-3.86||Based on the Benjamini \& Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means \[TIS-AZLI\] of -3.2%.||-3.86|-11.73|0.0001
71742455|NCT00757237|142996694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0023||||||Based on the Benjamini \& Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p\<0.05).|MMRM analysis|MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.|Treatment difference refers to TIS-AZLI.|"Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants.~With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%."||||0.0023
71742456|NCT00757237|142996695|NON_INFERIORITY_OR_EQUIVALENCE|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-13.86|-5.14||Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.|ANCOVA|ANCOVA model included treatment and Day 0 FEV1 percent predicted.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having \>= 84 days of inhaled tobramycin use in the previous 12 months.||-5.14|-13.86|<0.0001
71776997|NCT01163266|143053392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.779||||0.059|TWO_SIDED|95.0|0.979|3.233|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.233|0.979|0.059
71776998|NCT01163266|143053393|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|1.042||0.183|TWO_SIDED|95.0|-3.44|0.66|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.66|-3.44|0.183
71776999|NCT01163266|143053393|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.066||0.025|TWO_SIDED|95.0|-4.5|-0.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||-0.30|-4.50|0.025
71777000|NCT02586064|143053394|OTHER|||||||0.28|||||||t-test, 1 sided|||Baseline||||0.28
71664355|NCT00261443|142841946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)||||0.532
71664356|NCT00261443|142841946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison BUN Highest Value of Change During Phase 3||||0.169
71742457|NCT00757237|142996696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.0002||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|MMRM analysis|MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.|Treatment difference refers to TIS-AZLI|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having \>=84 days of inhaled tobramycin use in the previous 12 months.||||0.0002
71742458|NCT00757237|142996697|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED|||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.||||0.0025
71742459|NCT00757237|142996698|SUPERIORITY_OR_OTHER|||||||0.1114||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.||||0.1114
71742460|NCT00757237|142996699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61||||0.0048||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.||||0.0048
71742461|NCT00757237|142996700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13||||0.0189||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).||||0.0189
71742462|NCT00757237|142996701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.12||||0.0097||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).||||0.0097
71777001|NCT02586064|143053394|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|||||||||||||
71742463|NCT00757237|142996702|SUPERIORITY_OR_OTHER|||||||0.044||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).||||0.044
71742464|NCT00757237|142996703|SUPERIORITY_OR_OTHER|||||||0.004||0.0||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).||||0.004
71777002|NCT02586064|143053394|OTHER|||||||0.87|||||||t-test, 1 sided|||End of Treatment||||0.87
71777003|NCT02586064|143053394|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|||||||||||||
71664357|NCT00261443|142841947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.878||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Cholesterol (fasting)||||0.878
71777004|NCT02586064|143053394|EQUIVALENCE|Equivalence hypothesis was assessed using the confidence intervals for the mean differences compared to margins of equivalence (-7,7). The equivalence hypothesis was examined based on the difference between the amount of change from the baseline to the end of treatment on the CAPS between the two conditions. Confidence interval is -7.0 to 1.9.||||||0.26|||||||t-test, 2 sided|||Change||||0.26
71777005|NCT02586064|143053394|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|||||||||||||
71777006|NCT02586064|143053394|OTHER|||||||0.68|||||||t-test, 1 sided|||3 Month Post Treatment||||0.68
71664358|NCT00261443|142841947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)||||0.544
71664359|NCT00261443|142841947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.658||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3||||0.658
71664360|NCT00261443|142841948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatine Kinase||||0.043
71664361|NCT00261443|142841948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)||||0.019
71834288|NCT03725722|143172365|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.01|TWO_SIDED|95.0|-5.0|-1.3||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.3|-5.0|<0.01
71834289|NCT03725722|143172365|SUPERIORITY||Mean Difference (Net)|-3.0|||<|0.05|TWO_SIDED|95.0|-4.8|-1.2||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-1.2|-4.8|<0.05
71834290|NCT03725722|143172365|SUPERIORITY||Mean Difference (Net)|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.1||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-2.1|-5.8|<0.0001
71890875|NCT03093402|143303447|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.653|TWO_SIDED|95.0|-6.0|2.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||2.29|-6.00|0.653
71742465|NCT00757237|142996704|SUPERIORITY_OR_OTHER|||||||0.0004||||||No adjustments were made for multiple comparisons.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.||||0.0004
71742466|NCT01100320|142996734|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|99.9|||||TWO_SIDED|90.0|95.4|104.52|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.52|95.40|
71742467|NCT01100320|142996735|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.11|95.09|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.09|90.11|
71777007|NCT02586064|143053394|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|||||||||||||
71777008|NCT02586064|143053394|OTHER|||||||0.84|||||||t-test, 1 sided|||6 Month Follow Up||||0.84
71777009|NCT02586064|143053394|EQUIVALENCE|Confidence interval 95%, equivalence margin \[-7,7\].|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|3.05|||TWO_SIDED|||||||||||||
71777010|NCT02586064|143053395|OTHER|||||||0.36|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Baseline||||0.36
71777011|NCT02586064|143053395|OTHER|||||||0.34|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||4-Week||||0.34
71777012|NCT02586064|143053395|OTHER|||||||0.43|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||8-Week||||0.43
71777013|NCT02586064|143053395|OTHER|||||||0.09|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||6 Month Post Treatment||||0.09
71777014|NCT02586064|143053395|OTHER|||||||0.41|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||End of Treatment||||0.41
71777015|NCT02586064|143053395|SUPERIORITY|Superiority hypotheses were assessed using the confidence interval for the mean differences (-0.33 to 0.20) compared to margin of superiority (-.05).||||||0.64|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||Change||||0.64
71777016|NCT02586064|143053395|OTHER|||||||0.22|||||||t-test, 1 sided|One sided 97.5% confidence interval, superiority margin was 0.5||3 Month Post Treatment||||0.22
71777017|NCT02586064|143053396|OTHER|||||||0.4|||||||t-test, 1 sided|||Baseline||||0.40
71777018|NCT02586064|143053396|OTHER|||||||0.65|||||||t-test, 1 sided|||End of Treatment||||0.65
71777019|NCT02586064|143053396|OTHER|||||||0.64|||||||t-test, 1 sided|||Change||||0.64
71777020|NCT02586064|143053396|OTHER|||||||0.64|||||||t-test, 1 sided|||3 Month Post Treatment||||0.64
71777021|NCT02586064|143053396|OTHER|||||||0.76|||||||t-test, 1 sided|||6 Month Post Treatment||||0.76
71777022|NCT02586064|143053397|OTHER|||||||0.11|||||||t-test, 1 sided|||Baseline||||0.11
71777023|NCT02586064|143053397|OTHER|||||||0.48|||||||t-test, 1 sided|||4-Week||||0.48
71777024|NCT02586064|143053397|OTHER|||||||0.74|||||||t-test, 1 sided|||8-Week||||0.74
71777025|NCT02586064|143053397|OTHER|||||||0.34|||||||t-test, 1 sided|||End of Treatment||||0.34
71777026|NCT02586064|143053397|OTHER|||||||0.65|||||||t-test, 1 sided|||Change||||0.65
71777027|NCT02586064|143053397|OTHER|||||||0.14|||||||t-test, 1 sided|||3 Month Post Treatment||||0.14
71664362|NCT00261443|142841948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3||||0.176
71664363|NCT00261443|142841949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatinine||||0.105
71664364|NCT00261443|142841949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.634||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)||||0.634
71664365|NCT00261443|142841949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatinine During Phase 3||||0.958
71664366|NCT00261443|142841950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Eosinophils (relative)||||0.507
71742468|NCT01100320|142996736|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|92.6|||||TWO_SIDED|90.0|90.13|95.13|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||95.13|90.13|
71742469|NCT01219985|142996767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||We performed a McNemar test to compare the sensitivities obtained for each PET image method||||<0.001
71890876|NCT03093402|143303447|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.653|TWO_SIDED|95.0|-3.1|4.88||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||4.88|-3.10|0.653
71664367|NCT00261443|142841950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.834||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)||||0.834
71664368|NCT00261443|142841950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.511||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3||||0.511
71664369|NCT00261443|142841951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Glucose (fasting)||||0.741
71664370|NCT00261443|142841951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.962||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)||||0.962
71664371|NCT00261443|142841951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3||||0.592
71664372|NCT00261443|142841952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hemoglobin||||0.080
71664373|NCT00261443|142841952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)||||0.868
71664374|NCT00261443|142841952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3||||0.299
71664375|NCT00261443|142841953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.187||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hematocrit||||0.187
71664376|NCT00261443|142841953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)||||0.377
71664377|NCT00261443|142841953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3||||0.494
71664378|NCT00261443|142841954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HDL Cholesterol (fasting)||||0.180
71664379|NCT00261443|142841954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)||||0.950
71664380|NCT00261443|142841954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3||||0.342
71664381|NCT00261443|142841955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-Percent Beta||||0.349
71664382|NCT00261443|142841955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.624||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)||||0.624
71664383|NCT00261443|142841955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3||||0.329
71664384|NCT00261443|142841956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-IR||||0.550
71664385|NCT00261443|142841956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.554||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)||||0.554
71742470|NCT01219985|142996768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis was : lesions' SUVmax are equivalent with our without application of the CT-Based respiratory-gated PET method.||||<0.001
71664386|NCT00261443|142841956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample||||0.870
71742471|NCT00596752|142996769|SUPERIORITY_OR_OTHER|||||||0.2587||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.2587
71777028|NCT02586064|143053397|OTHER|||||||0.18|||||||t-test, 1 sided|||6 Month Post Treatment||||0.18
71777029|NCT02586064|143053398|OTHER|||||||0.08|||||||t-test, 1 sided|||Baseline||||0.08
71777030|NCT02586064|143053398|OTHER|||||||0.07|||||||t-test, 1 sided|||End of Treatment||||0.07
71777031|NCT02586064|143053398|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
71777032|NCT02586064|143053398|OTHER|||||||0.003|||||||t-test, 1 sided|||3 Month Post Treatment||||0.003
71777033|NCT02586064|143053398|OTHER|||||||0.03|||||||t-test, 1 sided|||6 Month Post Treatment||||0.03
71777034|NCT02586064|143053399|OTHER|||||||0.05|||||||t-test, 1 sided|||Baseline||||0.05
71664387|NCT00261443|142841957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.004
71664388|NCT00261443|142841957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase||||0.034
71777035|NCT02586064|143053399|OTHER|||||||0.04|||||||t-test, 1 sided|||End of Treatment||||0.04
71777036|NCT02586064|143053399|OTHER|||||||0.86|||||||t-test, 1 sided|||Change||||0.86
71777037|NCT02586064|143053399|OTHER||||||<|0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||<0.001
71777038|NCT02586064|143053399|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
71777039|NCT02586064|143053400|OTHER|||||||0.45|||||||t-test, 1 sided|||Baseline||||0.45
71777040|NCT02586064|143053400|OTHER|||||||0.71|||||||t-test, 1 sided|||End of Treatment||||0.71
71777041|NCT02586064|143053400|OTHER|||||||0.6|||||||t-test, 1 sided|||Change||||0.60
71777042|NCT02586064|143053400|OTHER|||||||0.13|||||||t-test, 1 sided|||3 Month Post Treatment||||0.13
71777043|NCT02586064|143053400|OTHER|||||||0.8|||||||t-test, 1 sided|||6 Month Post Treatment||||0.80
71777044|NCT02586064|143053401|OTHER|||||||0.35|||||||t-test, 1 sided|||Baseline||||0.35
71777045|NCT02586064|143053401|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
71777046|NCT02586064|143053401|OTHER|||||||0.74|||||||t-test, 1 sided|||Change||||0.74
71777047|NCT02586064|143053401|OTHER|||||||0.03|||||||t-test, 1 sided|||3 Month Post Treatment||||0.03
71777048|NCT02586064|143053401|OTHER|||||||0.22|||||||t-test, 1 sided|||6 Month Post Treatment||||0.22
71777049|NCT02586064|143053402|OTHER|||||||0.39|||||||t-test, 1 sided|||Baseline||||0.39
71777050|NCT02586064|143053402|OTHER|||||||0.15|||||||t-test, 1 sided|||End of Treatment||||0.15
71777051|NCT02586064|143053402|OTHER|||||||0.72|||||||t-test, 1 sided|||Change||||0.72
71777052|NCT02586064|143053402|OTHER|||||||0.04|||||||t-test, 1 sided|||3 Month Post Treatment||||0.04
71777053|NCT02586064|143053402|OTHER|||||||0.19|||||||t-test, 1 sided|||6 Month Post Treatment||||0.19
71777054|NCT02586064|143053403|OTHER|||||||0.33|||||||t-test, 1 sided|||Baseline||||0.33
71777055|NCT02586064|143053403|OTHER|||||||0.11|||||||t-test, 1 sided|||End of Treatment||||0.11
71777056|NCT02586064|143053403|OTHER|||||||0.88|||||||t-test, 1 sided|||Change||||0.88
71777057|NCT02586064|143053403|OTHER|||||||0.06|||||||t-test, 1 sided|||3 Month Post Treatment||||0.06
71777058|NCT02586064|143053403|OTHER|||||||0.56|||||||t-test, 1 sided|||6 Month Post Treatment||||0.56
71777059|NCT02586064|143053404|OTHER|||||||0.16|||||||t-test, 1 sided|||Baseline||||0.16
71777060|NCT02586064|143053404|OTHER|||||||0.06|||||||t-test, 1 sided|||End of Treatment||||0.06
71777061|NCT02586064|143053404|OTHER|||||||0.46|||||||t-test, 1 sided|||Change||||0.46
71777062|NCT02586064|143053404|OTHER|||||||0.001|||||||t-test, 1 sided|||3 Month Post Treatment||||0.001
71777063|NCT02586064|143053404|OTHER|||||||0.002|||||||t-test, 1 sided|||6 Month Post Treatment||||0.002
71777064|NCT02586064|143053405|OTHER|||||||0.24|||||||t-test, 1 sided|||Baseline||||0.24
71777065|NCT02586064|143053405|OTHER|||||||0.81|||||||t-test, 1 sided|||End of Treatment||||0.81
71777066|NCT02586064|143053405|OTHER|||||||0.24|||||||t-test, 1 sided|||Change||||0.24
71777067|NCT02586064|143053406|OTHER|||||||0.41|||||||t-test, 1 sided|||Baseline||||0.41
71777068|NCT02586064|143053406|OTHER|||||||0.21|||||||t-test, 1 sided|||End of Treatment||||0.21
71777069|NCT02586064|143053406|OTHER|||||||0.5|||||||t-test, 1 sided|||Change||||0.50
71777070|NCT02586064|143053407|OTHER|||||||0.7|||||||t-test, 1 sided|||Baseline||||0.70
71777071|NCT02586064|143053407|OTHER|||||||0.96|||||||t-test, 1 sided|||Week 4||||0.96
71777072|NCT02586064|143053407|OTHER|||||||0.59|||||||t-test, 1 sided|||Week 8||||0.59
71777073|NCT02586064|143053407|OTHER|||||||0.61|||||||t-test, 1 sided|||End of Treatment||||0.61
71777074|NCT02586064|143053407|OTHER|||||||0.84|||||||t-test, 1 sided|||Change||||0.84
71777075|NCT02586064|143053407|OTHER|||||||0.3|||||||t-test, 1 sided|||3 Month Follow Up||||0.30
71777076|NCT02586064|143053407|OTHER|||||||0.16|||||||t-test, 1 sided|||6 Month Post Treatment||||0.16
71777077|NCT04308304|143053426|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
71777078|NCT04308304|143053426|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
71777079|NCT04308304|143053426|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
71664389|NCT00261443|142841957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3||||0.091
71664390|NCT00261443|142841958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.808||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline LDL Cholesterol (fasting)||||0.808
71664391|NCT00261443|142841958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.507
71664392|NCT00261443|142841958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.948||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)||||0.948
71664393|NCT00261443|142841959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.967||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Neutrophils (relative)||||0.967
71742472|NCT00596752|142996769|SUPERIORITY_OR_OTHER|||||||0.3463||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.3463
71758519|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71664394|NCT00261443|142841959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.486||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)||||0.486
71664395|NCT00261443|142841959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.323||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Sample||||0.323
71664396|NCT00261443|142841960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline in Platelet Count||||0.663
71664397|NCT00261443|142841960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.322
71664398|NCT00261443|142841960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.358||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.358
71664399|NCT00261443|142841960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.541||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Sample||||0.541
71664400|NCT00261443|142841961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.412||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Prolactin||||0.412
71664401|NCT00261443|142841961|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline at Week 52 (LOCF)||||<0.001
71664402|NCT00261443|142841961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Sample||||0.004
71664403|NCT00261443|142841962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Bilirubin||||0.630
71664404|NCT00261443|142841962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.675
71664405|NCT00261443|142841962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample||||0.592
71664406|NCT00261443|142841963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Triglycerides (fasting)||||0.273
71664407|NCT00261443|142841963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.489
71664408|NCT00261443|142841963|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Sample||||0.415
71664409|NCT00261443|142841964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Uric Acid||||0.189
71664410|NCT00261443|142841964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.350
71664411|NCT00261443|142841964|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Sample||||0.799
71664412|NCT00261443|142841965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.124||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Leukocytes||||0.124
71664413|NCT00261443|142841965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)||||0.295
71664414|NCT00261443|142841965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Highest Value of Change in Leukocytes, Phase 3||||0.735
71742473|NCT00596752|142996770|SUPERIORITY_OR_OTHER|||||||0.0173||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."||||0.0173
71742474|NCT00596752|142996770|SUPERIORITY_OR_OTHER|||||||0.1154||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~This is the statistical analysis of stage 1 and stage 2 combined."||||0.1154
71742475|NCT04797780|142996781|SUPERIORITY||Difference in CR Rate|5.06||||0.2084|TWO_SIDED|95.0|-7.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|-7.1|0.2084
71742476|NCT03421106|142996820|SUPERIORITY||Mean Difference (Net)|2.53||||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||0.23
71777080|NCT04308304|143053426|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
71777081|NCT04308304|143053427|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.69|||||TWO_SIDED|90.0|0.55|0.86||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.86|0.55|
71777082|NCT04308304|143053427|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.66|||||TWO_SIDED|95.0|0.53|0.82||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.82|0.53|
71777083|NCT04308304|143053427|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.74|||||TWO_SIDED|95.0|0.55|1.0||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.00|0.55|
71777084|NCT04308304|143053427|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.77|||||TWO_SIDED|95.0|0.56|1.05||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.05|0.56|
71896185|NCT02495077|143314345|SUPERIORITY||Mean Difference (Final Values)|-1.35||||0.601|TWO_SIDED|95.0|-6.41|3.72|||Mixed Models Analysis|||Day 30. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 30 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 30. Random effects for the intercept and eGFR collection day were utilized in the model.||3.72|-6.41|0.601
71664415|NCT00261443|142841965|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Lowest Value of Change in Leukocytes, Phase 3||||0.505
71777085|NCT04308304|143053428|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.67|||||TWO_SIDED|90.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
71777086|NCT04308304|143053428|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.52|0.87||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.87|0.52|
71777087|NCT04308304|143053428|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.79|||||TWO_SIDED|95.0|0.59|1.06||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.06|0.59|
71777088|NCT04308304|143053428|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.74|||||TWO_SIDED|95.0|0.51|1.08||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||1.08|0.51|
71777089|NCT04308304|143053429|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|Geometric Mean Ratio (GMR)|0.62|||||TWO_SIDED|90.0|0.48|0.8||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.80|0.48|
71777090|NCT04308304|143053429|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.67|||||TWO_SIDED|95.0|0.55|0.81||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.81|0.55|
71777091|NCT04308304|143053429|OTHER|MK-1942 + Donepezil PK / MK-1942 Alone PK|GMR|0.68|||||TWO_SIDED|95.0|0.49|0.93||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.93|0.49|
71664416|NCT00261443|142841967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.213||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc Bazett||||0.213
71777092|NCT04308304|143053429|OTHER|MK-1942 + Donepezil PK / MK-1942 PK Alone|GMR|0.72|||||TWO_SIDED|95.0|0.54|0.98||||||'MK-1942 Alone PK' are unpublished data from MK-1942-004||0.98|0.54|
71777093|NCT04308304|143053434|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.34|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
71777094|NCT04308304|143053435|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.22|STANDARD_ERROR_OF_MEAN|52.4||||||||||||||||
71777095|NCT04308304|143053436|OTHER|Donepezil Accumulation Ratio (Day 28/Day -1)|Geometric mean|1.46|STANDARD_ERROR_OF_MEAN|60.8||||||||||||||||
71777096|NCT01555983|143053480|SUPERIORITY_OR_OTHER||Cochran-Armitage trend tes|0.0001|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.||||<.05
71777097|NCT00573183|143053493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3404|STANDARD_ERROR_OF_MEAN|0.4134|<|0.05|TWO_SIDED|95.0|1.2019|9.2842||95% confidence interval|Mixed Models Analysis|A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.|The STAGE-12 group represented the numerator and TAU represented the reference group/denominator|Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.||9.2842|1.2019|<0.05
71777098|NCT00573183|143053493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4373|STANDARD_ERROR_OF_MEAN|0.4134|<|0.01|TWO_SIDED|95.0|1.0131|5.8637|||Mixed Models Analysis|||||5.8637|1.0131|<0.01
71777099|NCT00573183|143053494|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical Model - zero-inflated negative binomial random-effects regression|Zero-inflated negative binomial random-e|Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance||Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups||||<0.05
71777100|NCT05027464|143053495|SUPERIORITY||Odds Ratio (OR)|1.249||||0.202|TWO_SIDED|95.0|0.888|1.759||Not adjusted for multiple comparisons; a priori threshold was P \< 0.05.|Regression, Logistic|Patient demographics were fixed effects, and randomization units with clinics nested within randomization units were random effects.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Generalized linear mixed model to account for patient demographics and hierarchical levels for clinics nested within VAHCS. Null hypothesis is that both arms perform equivalently in vaccine uptake after a year. Power was based on recruited VAHCSs and at least 1,000 Veterans per clinic. Using two-sided 0.05 type I error rate, 5-20% outcome rate in UC, we have 90% power to detect between a 9.6% and 14.6% difference with a total sample size of 90,000 to 100,000.||1.759|0.888|0.202
71777101|NCT05027464|143053495|SUPERIORITY||Odds Ratio (OR)|1.228||||0.247|TWO_SIDED|95.0|0.867|1.738|||Regression, Logistic|||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.738|0.867|0.247
71777102|NCT05027464|143053495|SUPERIORITY||Odds Ratio (OR)|1.263||||0.455|TWO_SIDED|95.0|0.684|2.334|||Regression, Logistic|||Sensitivity analysis; same model and null hypothesis but reassigning small clinics to their parent VAHCS facility, small meaning \< 100 participants. This data set uses the primary analysis data set with the primary visit constraint.||2.334|0.684|0.455
71777103|NCT05027464|143053495|SUPERIORITY||Odds Ratio (OR)|1.26||||0.364|TWO_SIDED|95.0|0.765|2.075|||Regression, Logistic|||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||2.075|0.765|0.364
71777104|NCT05027464|143053495|SUPERIORITY||Odds Ratio (OR)|1.268||||0.168|TWO_SIDED|95.0|0.904|1.778|||Regression, Logistic|||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.778|0.904|0.168
71777105|NCT05027464|143053496|SUPERIORITY||Odds Ratio (OR)|0.993||||0.976|TWO_SIDED|95.0|0.643|1.535||P \< 0.05 and no multiple comparison adjustment|Regression, Logistic|We adjusted for patient demographics as fixed effects and randomization units and associated clinics as a three-level random effect.|An odds ratio above one indicates favoring the intervention arm over the usual care arm.|Power calculation is similar to the calculation for the primary outcome. Null hypothesis is described in the outcome comparison related to this statistical analysis plan.||1.535|0.643|.976
71777106|NCT05027464|143053496|SUPERIORITY||Odds Ratio (OR)|0.978||||0.893|TWO_SIDED|95.0|0.702|1.361|||Regression, Logistic|GLMM||Sensitivity analysis, same null hypothesis and model as primary analysis but different pool of patients: Not constrained to Veterans with at least one primary care visit||1.361|0.702|0.893
71777107|NCT05027464|143053496|SUPERIORITY||Odds Ratio (OR)|0.961||||0.863|TWO_SIDED|95.0|0.613|1.507|||Regression, Logistic|GLMM||Sensitivity Analysis: same model and null hypothesis as primary outcome but the source of vaccination records omits Medicare claims data. The primary data source had included Medicare claims data on vaccination records as a supplement to the VA data.||1.507|0.613|0.863
71777108|NCT05027464|143053496|SUPERIORITY||Odds Ratio (OR)|1.011||||0.963|TWO_SIDED|95.0|0.636|1.607|||Regression, Logistic|GLMM||"Sensitivity Analysis: same model and null hypothesis as primary analysis model but the source of data is supplemented by state level registries, named IZ Gateway, which was deployed summer of 2023 where Veteran records of vaccination could be updated at the VA from external vaccination facilities if the Veteran entered the VA in the same state as that vaccination facility. The primary analysis data contains Medicare claims data in this analysis, too."||1.607|0.636|0.963
71777109|NCT05027464|143053497|SUPERIORITY||Odds Ratio (OR)|1.191||||0.395|TWO_SIDED|95.0|0.796|1.781||Threshold: P \< 0.05; not adjusted for multiple comparisons|Regression, Logistic|Generalized linear mixed modeling adjusted for baseline covariates and hierarchical levels for randomization units and clinics within them.|Odds ratio in favor of intervention arm (MI) has values higher than 1.|No power calculation for this exploratory outcome. Null hypothesis is that both arms will have equal uptake rates of the COVID-19 Booster vaccination during the study period.||1.781|0.796|0.395
71777110|NCT05027464|143053498|SUPERIORITY||Odds Ratio (OR)|1.128||||0.119|TWO_SIDED|95.0|0.97|1.311||P-value was not adjusted for multiple comparisons and the p-value threshold was \< 0.05.|Regression, Logistic|Generalized linear mixed model adjusting for baseline covariates and flu vaccine in prior year, with hierarchical random effects for ran. unit/site|Odds ratio in favor of novel intervention arm has values higher than 1|Null hypothesis is that both study arms will have equal rates of flu vaccination uptake during the study period. No power calculation since this outcome is exploratory.||1.311|0.97|0.119
71777111|NCT04066647|143053516|SUPERIORITY||Mean Difference (Final Values)|0.93928821||||0.9|TWO_SIDED||||||t-test, 2 sided|2 tailed, unpaired t test with Bonferroni correction||||||0.9
71777112|NCT01856907|143053534|SUPERIORITY|||||||0.035|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.035
71777113|NCT01856907|143053535|SUPERIORITY|||||||0.044|||||||ANOVA|||Subjects (SS)/ Treatment Group x repeated measures (visit) design||||0.044
71777114|NCT01856907|143053536|SUPERIORITY|||||||0.034|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.034
71777115|NCT01856907|143053537|SUPERIORITY|||||||0.047|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||.047
71742477|NCT02663622|142996831|SUPERIORITY||Cox Proportional Hazard|0.13||||0.0274|TWO_SIDED|95.0|0.01|0.62|||Log Rank|Log-rank test stratified by the matched sets||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade III-IV AGFS in days was 135.8 with an SD of 64.66.||0.62|0.01|0.0274
71742478|NCT02663622|142996832|SUPERIORITY||Cox Proportional Hazard|0.57||||0.0988|TWO_SIDED|95.0|0.3|1.08|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean grade II-IV AGFS in days was 104.7 with an SD of 72.28.||1.08|0.30|0.0988
71742479|NCT02663622|142996838|SUPERIORITY||Cox Proportional Hazard|1.12||||0.9088|TWO_SIDED|95.0|0.43|2.88|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean OS in days was 319.3 with an SD of 93.83.||2.88|0.43|0.9088
71742480|NCT02663622|142996840|SUPERIORITY||Cox Proportional Hazard|1.27||||0.6131|TWO_SIDED|95.0|0.66|2.46|||Log Rank|||A hazard ratio was calculated based on a Cox proportional hazards regression model with treatment as a factor using the robust sandwich covariance estimator, comparing the CD24Fc 960 mg arm to a matched control group consisting of 92 participants from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational databases of clinical information on HCT, whose mean RFS in days was 296.0 with an SD of 115.32.||2.46|0.66|0.6131
71742481|NCT03868254|142996856|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
71742482|NCT03868254|142996856|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
71742483|NCT03868254|142996857|OTHER||||||<|0.0001|||||||Paired t-test|||||||<.0001
71742484|NCT03868254|142996857|OTHER|||||||0.0001|||||||Paired t-test|||||||0.0001
71777116|NCT01856907|143053538|SUPERIORITY|||||||0.017|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.017
71742485|NCT03868254|142996858|OTHER|||||||0.003|||||||Paired t-test|||||||0.0030
71742486|NCT03868254|142996858|OTHER|||||||0.0018|||||||Paired t-test|||||||0.0018
71742487|NCT03868254|142996859|OTHER|||||||0.0053|||||||Paired t-test|||||||0.0053
71742488|NCT03868254|142996859|OTHER|||||||0.0472|||||||Paired t-test|||||||0.0472
71742489|NCT02848222|142996866|SUPERIORITY|||||||0.02||||||Threshold for significance was p \< 0.05|ANOVA|||||||0.02
71742490|NCT00797277|142996918|NON_INFERIORITY_OR_EQUIVALENCE|There was no previous study comparing these 2 treatments. We hypothesized that the mean difference between the 2 treatments would be small.|Mean Difference (Final Values)|1.0|||<|0.05|||||||t-test, 2 sided|||we hypothesized that there would be no statistical significant difference between the 2 groups in the primary outcome.||||<0.05
71742491|NCT01751984|142996920|SUPERIORITY||Least squares mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.4|-22.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-22.1|-35.4|<0.0001
71742492|NCT01751984|142996921|SUPERIORITY||Least squares mean difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-24.3|-11.8|||ANCOVA||Estimation from Week 2. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-11.8|-24.3|<0.0001
71742493|NCT01751984|142996921|SUPERIORITY||Least squares mean difference|-30.0|||<|0.0001|TWO_SIDED|95.0|-35.2|-24.7|||ANCOVA||Estimation from Week 4. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-24.7|-35.2|<0.0001
71742494|NCT01751984|142996921|SUPERIORITY||Least squares mean difference|-28.8|||<|0.0001|TWO_SIDED|95.0|-36.9|-20.8|||ANCOVA||Estimation from Week 6. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-20.8|-36.9|<0.0001
71777117|NCT01856907|143053539|SUPERIORITY|||||||0.014|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.014
71777118|NCT01856907|143053540|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.042
71742495|NCT01751984|142996921|SUPERIORITY||Least squares mean difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.2|-19.8|||ANCOVA||Estimation from Week 8. The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-19.8|-37.2|<0.0001
71742496|NCT01751984|142996922|SUPERIORITY||Least squares mean difference|-5.8||||0.1892|TWO_SIDED|95.0|-14.5|2.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||2.9|-14.5|0.1892
71742497|NCT01751984|142996923|SUPERIORITY||Least squares mean difference|-20.9|||<|0.0001|TWO_SIDED|95.0|-28.0|-13.9|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-13.9|-28.0|<0.0001
71742498|NCT01751984|142996924|SUPERIORITY||Least squares mean difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-24.2|-12.7|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-12.7|-24.2|<0.0001
71777119|NCT01856907|143053541|SUPERIORITY|||||||0.002|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.002
71777120|NCT01856907|143053542|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
71742499|NCT01751984|142996925|SUPERIORITY||Least squares mean difference|18.7|||=|0.0962|TWO_SIDED|95.0|-3.5|40.8|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||40.8|-3.5|=0.0962
71742500|NCT01751984|142996926|SUPERIORITY||Least squares mean difference|-15.3|||=|0.0019|TWO_SIDED|95.0|-24.6|-6.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||-6.0|-24.6|=0.0019
71742501|NCT01751984|142996927|SUPERIORITY||Least squares mean difference|-4.2|||=|0.2555|TWO_SIDED|95.0|-11.7|3.2|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||3.2|-11.7|=0.2555
71742502|NCT01751984|142996928|SUPERIORITY||Least squares mean difference|11.7||||0.2563|TWO_SIDED|95.0|-8.8|32.1|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.1|-8.8|0.2563
71742503|NCT01751984|142996929|SUPERIORITY||Least squares mean difference|-23.7||||0.2565|TWO_SIDED|95.0|-65.4|18.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||18.0|-65.4|0.2565
71742504|NCT01751984|142996930|SUPERIORITY||Least squares mean difference|4.0||||0.776|TWO_SIDED|95.0|-24.1|32.0|||ANCOVA||The least squares mean difference was calculated as the value for the ETC-1002 60 mg arm minus the value for the placebo arm.|||32.0|-24.1|0.7760
71742505|NCT01751984|142996931|SUPERIORITY||Clopper-Pearson methodology|61.8|||<|0.0001|TWO_SIDED|95.0|45.4|78.1||Based on Fisher's exact test comparing the proportion of participants who achieved LDL-C goal at Week 8 (End of Study) in the ETC-1002 and placebo groups.|Fisher Exact||ETC-1002 minus placebo for the proportion of participants who achieved LDL-C goal at Week 8 (End of Study). The confidence interval was based on a normal approximation to the binomial distribution.|||78.1|45.4|<0.0001
71742506|NCT03187132|142996952|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|1.17||0.111|TWO_SIDED|95.0|-4.15|0.43|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||.43|-4.15|.111
71742507|NCT03187132|142996953|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.27||0.612|TWO_SIDED|95.0|-1.84|3.12|||Mixed Models Analysis||The estimate is for the Digital Pain Reduction Kit arm.|We used a repeated measures linear mixed model featuring fixed effects for time, study arm, and score at week 1, and random effects to account for within subject variation.||3.12|-1.84|.612
71742508|NCT03187132|142996954|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.58||0.87|TWO_SIDED|95.0|-5.51|4.66|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||4.66|-5.51|.87
71742509|NCT03187132|142996954|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.274||0.787|TWO_SIDED|95.0|-0.54|0.54|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.54|-.54|.787
71742510|NCT03187132|142996954|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.569|TWO_SIDED|95.0|-0.88|0.48|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.48|-.88|.569
71742511|NCT03187132|142996955|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.467|TWO_SIDED|95.0|-0.23|0.49|||t-test, 2 sided|||For work productivity measures, self-reported opioid utilization, and post-study measures of satisfaction, we used t-tests for normally distributed data and Wilcoxon Rank-Sum tests for non-normally distributed data.||.49|-.23|.467
71742512|NCT03187132|142996956|SUPERIORITY||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.986||0.852|TWO_SIDED|95.0|0.07|9.07|||Regression, Logistic|||We used a multilevel logistic regression with random effects at the individual level and fixed effects for week and study-arm.||9.07|.07|.852
71742513|NCT03594773|142996976|SUPERIORITY||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|1.56||0.752|TWO_SIDED|95.0|-3.62|2.63|||t-test, 2 sided|df=56, equal variances assumed||||2.63|-3.62|.752
71777121|NCT01856907|143053543|SUPERIORITY|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test||||0.004
71742514|NCT03594773|142996977|SUPERIORITY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|2.62||0.633|TWO_SIDED|95.0|-4.01|6.52|||t-test, 2 sided|df=49, equal variances assumed||||6.52|-4.01|.633
71742515|NCT03594773|142996978|SUPERIORITY||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.73||0.586|TWO_SIDED|95.0|-2.53|4.44|||t-test, 2 sided|df=49, equal variances assumed||||4.44|-2.53|.586
71742516|NCT01450761|142996998|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.3775|TWO_SIDED|95.0|0.807|1.085|||Log Rank||HR = ipilimumab over placebo|||1.085|0.807|0.3775
71777122|NCT01856907|143053544|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
71742517|NCT01450761|142996999|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.961||||0.5678|TWO_SIDED|95.0|0.838|1.102|||Log Rank||HR = ipilimumab over placebo|||1.102|0.838|0.5678
71742518|NCT01450761|142997000|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0161|TWO_SIDED|95.0|0.747|0.971|||Log Rank||HR = ipilimumab over placebo|||0.971|0.747|0.0161
71742519|NCT04308941|142997011|OTHER|The mean and standard deviation was analyzed.||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71742520|NCT00740207|142997015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.7142|TWO_SIDED|95.0|-1.3|0.9|||t-test, 2 sided|||Paired t-test to compare difference between the investigational product's mean change from predose to postdose||0.9|-1.3|0.7142
71777123|NCT01604408|143053550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.426|||<|0.001|TWO_SIDED|95.0|0.192|0.66|||Mixed Model Repeated Measures|||||0.660|0.192|<0.001
71777124|NCT01604408|143053551|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.461||||0.073|TWO_SIDED|90.0|-0.883|-0.039|||Mixed Model Repeated Measures|||||-0.039|-0.883|0.073
71890877|NCT03093402|143303447|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.653|TWO_SIDED|95.0|-4.31|3.67||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Interference T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -4.9 (-7.6, -2.1).|Each active JBT-101 cohort is compared to placebo.||3.67|-4.31|0.653
71742521|NCT00740207|142997016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.1698|TWO_SIDED|95.0|-79.2|-0.8|||Fisher Exact|||Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.||-0.8|-79.2|0.1698
71890878|NCT03093402|143303448|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.245|TWO_SIDED|95.0|-2.56|0.29||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.29|-2.56|0.245
71890879|NCT03093402|143303448|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.245|TWO_SIDED|95.0|-1.93|0.8||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.80|-1.93|0.245
71742522|NCT00740207|142997017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0||||1|TWO_SIDED|95.0|-28.6|8.6|||Fisher Exact|||Paired t-test to compare difference in percentage between the number of participants requiring repeat injections||8.6|-28.6|1.000
71742523|NCT00216671|142997051|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6.|Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|4.1||0.784|TWO_SIDED|95.0|-9.24|6.99||An ANCOVA model with treatment as factor was used. The comparison between the 2 treatment groups was performed based on the least-squares means obtained from the ANCOVA model.|ANCOVA|||Assuming a difference of 3 points in favor of early initiation of treatment with Risperdal Consta, a sample size of 87 subjects per treatment arm has a power of 80% to demonstrate non-inferiority at the 0.025-level (1-sided). It was expected that about 20% of randomized subjects had to be excluded from the per-protocol (PP) analysis. Therefore, 220 subjects were to be included.||6.99|-9.24|0.784
71742524|NCT00216671|142997054|SUPERIORITY_OR_OTHER|||||||0.8||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.800
71742525|NCT00216671|142997054|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
71742526|NCT00216671|142997054|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.||||<0.001
71664417|NCT00261443|142841967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.708||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)||||0.708
71742527|NCT00216671|142997055|SUPERIORITY_OR_OTHER|||||||0.798||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.798
71742528|NCT00216671|142997055|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71742529|NCT00216671|142997055|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71742530|NCT00216671|142997056|SUPERIORITY_OR_OTHER|||||||0.519||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.519
71777125|NCT01604408|143053552|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.062||||0.191|TWO_SIDED|90.0|-2.4|0.276|||Mixed Model Repeated Measures|||||0.276|-2.400|0.191
71834291|NCT03725722|143172365|SUPERIORITY||Median Difference (Net)|-5.7|||<|0.0001|TWO_SIDED|95.0|-7.5|-3.9||The stat. test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. were excluded from the analysis. Likewise for missing data due to COVID-19 pandemic.|Mixed Models Analysis|||"Least square (LS) means were calculated using a mixed model response model (MMRM) on post-baseline responses up to Week 8 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom and the mean modelled as follows:~Change from baseline in EASI = treatment x visit + baseline EASI x visit + region + baseline vIGA-AD.~The primary comparison between each active delgocitinib dose and delgocitinib cream vehicle was at Week 8."||-3.9|-7.5|<0.0001
71742531|NCT00216671|142997056|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71742532|NCT00216671|142997056|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71742533|NCT00216671|142997056|SUPERIORITY_OR_OTHER|||||||0.721||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||0.721
71742534|NCT00216671|142997056|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71742535|NCT00216671|142997056|SUPERIORITY_OR_OTHER||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.001
71742536|NCT01369784|142997087|SUPERIORITY_OR_OTHER|||||||0.812|||||||Fisher Exact|||||||0.812
71742537|NCT01369784|142997088|SUPERIORITY_OR_OTHER|||||||0.612|||||||Chi-squared|||||||0.612
71742538|NCT01369784|142997089|SUPERIORITY_OR_OTHER|||||||0.402|||||||Chi-squared|||||||0.402
71777126|NCT01604408|143053553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.478|TWO_SIDED|90.0|-0.023|0.057|||Mixed Model Repeated Measures|||||0.057|-0.023|0.478
71742539|NCT01369784|142997090|SUPERIORITY_OR_OTHER|||||||0.557|||||||Chi-squared|||||||0.557
71742540|NCT01369784|142997091|SUPERIORITY_OR_OTHER|||||||0.234|||||||Chi-squared|||||||0.234
71742541|NCT01369784|142997092|SUPERIORITY_OR_OTHER|||||||0.057|||||||Fisher Exact|||||||0.057
71742542|NCT01369784|142997093|SUPERIORITY_OR_OTHER|||||||0.117|||||||Fisher Exact|||||||0.117
71742543|NCT03884790|142997108|OTHER|Descriptive statistical analysis|||||||||||||||||Descriptive statistical analysis|||
71742544|NCT04378270|142997115|OTHER||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|1.61||0.0796|TWO_SIDED|95.0|-0.3687|6.2287|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||6.2287|-0.3687|0.0796
71742545|NCT04378270|142997116|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.879||0.0634|TWO_SIDED|95.0|-3.5014|0.1014|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% Confidence Interval (CI) of the difference is reported. The P-value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||0.1014|-3.5014|0.0634
71742546|NCT04378270|142997117|OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|5.492||0.002|TWO_SIDED|95.0|7.4498|29.9502|||t-test, 2 sided|Degrees of Freedom (DF)- 28||This procedure calculates the difference between the observed means in two independent samples (two collected assessment timepoints, screening and 4 week follow up visits). A significance value (P-value) and 95% confidence interval (CI) of the difference is reported. The P value is the probability of obtaining the observed difference between the samples if the null hypothesis were true. The null hypothesis is the hypothesis that the difference is 0.||29.9502|7.4498|0.0020
71777127|NCT02758171|143053576|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|101.71|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|99.818|103.644|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.644|99.818|<0.0001
71742547|NCT04378270|142997118|OTHER||Mean Difference (Net)|16.67|STANDARD_ERROR_OF_MEAN|4.327||0.0006|TWO_SIDED|95.0|7.8069|25.5331|||t-test, 2 sided|Degrees of freedom (DF)- 28||||25.5331|7.8069|0.0006
71664418|NCT00261443|142841967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3||||0.107
71664419|NCT00261443|142841968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc (0.33)||||0.205
71742548|NCT04378270|142997121|OTHER||Mean pain scale|17.87|STANDARD_DEVIATION|2.39||0.0001|TWO_SIDED|95.0|16.5465|19.1935|||t-test, 2 sided|Degrees of freedom (DF)- 14||This procedure calculates the difference of an observed mean (from the assessment collected at the 4 week visit) with a hypothesized mean value (10, a mid level scale score). A significance value (P-value) and 95% Confidence Interval (CI) of the observed mean is reported. The P-value is the probability of obtaining the observed mean in the sample if the null hypothesis value were the true value.||19.1935|16.5465|0.0001
71742549|NCT03838978|142997127|SUPERIORITY|Non-inferiority is demonstrated if the 90% LB \> -10.0%. If non-inferiority was met, superiority could be tested. Superiority is demonstrated if 97.5% LB \> 0.0%.||||||||||||||||For missing data in both Arms/Groups, multiple imputation was performed for the primary CCS analysis.|Device group differences and two-sided 90% and 97.5% confidence interval lower bounds (LB) adjusting for propensity score (PS) subclass based on PS subclass weights (ATT). Noninferiority is demonstrated if the 90% LB \> -10.0%. Superiority is demonstrated if 97.5% LB \>0.0%. Two-sided 97.5% LB is evaluated rather than two-sided 95.0% LB since the superiority type 1 error is split between testing superiority in terms of Month 24 CCS and then separately for a set of superiority secondary endpoints with type 1 error control maintained through the use of Hochberg approach (following demonstration of non-inferiority).|||
71742550|NCT02119663|142997153|OTHER||Hazard Ratio (HR)|1.584|||||TWO_SIDED|95.0|0.886|2.83||||||||2.830|0.886|
71742551|NCT00892775|142997159|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% confidence interval around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.64|||||TWO_SIDED|95.0|-2.29|1.76||||||||1.76|-2.29|
71742552|NCT00892775|142997159|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.74|||||TWO_SIDED|95.0|-6.14|5.58||||||||5.58|-6.14|
71742553|NCT00892775|142997159|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.32|||||TWO_SIDED|95.0|-1.78|2.08||||||||2.08|-1.78|
71742554|NCT00892775|142997159|NON_INFERIORITY|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|4.69|||||TWO_SIDED|95.0|0.72|10.34||||||||10.34|0.72|
71742555|NCT00699660|142997169|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.|Regression, Linear|Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.||Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.||||<.001
71742556|NCT00699660|142997170|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<.01
71742557|NCT00699660|142997171|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Descriptive statistics on mean and standard deviation.|t-test, 2 sided|||||||>.05
71742558|NCT00699660|142997172|SUPERIORITY_OR_OTHER||Slope|47.3|STANDARD_ERROR_OF_MEAN|18.86||0.012|TWO_SIDED|||||0.05 level based on a two tailed test.|Regression, Linear|Covariates included years of experience, use of template, use of tests, age, education, study site.||Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)||||.012
71742559|NCT00064792|142997173|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The primary outcome variable will be the serum cholesterol/total sterol ratio.||||0.002
71777128|NCT02758171|143053577|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|99.39|STANDARD_DEVIATION|13.1|<|0.0001|TWO_SIDED|90.0|95.29|103.672|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.672|95.290|<0.0001
71664420|NCT00261443|142841968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.669||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)||||0.669
71664421|NCT00261443|142841968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3||||0.072
71664422|NCT00261443|142841969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline PR||||0.012
71664423|NCT00261443|142841969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)||||0.027
71664424|NCT00261443|142841969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in PR, Phase 3||||0.128
71742560|NCT00064792|142997174|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71664425|NCT00261443|142841970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.571||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline RR||||0.571
71834292|NCT03725722|143172366|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model: Linear model"||This endpoint was evaluated by determining if there was a dose-response relationship between the vIGA-AD response rate at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response.||||<0.0001
71834293|NCT03725722|143172366|SUPERIORITY||Risk Difference (RD)|8.2|||>|0.05|TWO_SIDED|95.0|-5.6|21.9||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||21.9|-5.6|>0.05
71834294|NCT03725722|143172366|SUPERIORITY||Risk Difference (RD)|19.3|||<|0.05|TWO_SIDED|95.0|3.9|34.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference.||34.6|3.9|<0.05
71834295|NCT03725722|143172366|SUPERIORITY||Risk Difference (RD)|20.3|||<|0.05|TWO_SIDED|95.0|5.4|35.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||35.2|5.4|<0.05
71834296|NCT03725722|143172366|SUPERIORITY||Risk Difference (RD)|38.3|||<|0.0001|TWO_SIDED|95.0|22.3|54.3||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||54.3|22.3|<0.0001
71834297|NCT03725722|143172367|SUPERIORITY||||||<|0.0001||||||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Multiple contrast test|"P-values were adj. for multiple comparisons. Models with adj. p-value \<0.025 were stat. sign. diff. from a flat dose-response model.~Model:Emax model"||This endpoint was evaluated by determining if there was a dose-response relationship between EASI75 at Week 8 and the dose administered using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response||||<0.0001
71834298|NCT03725722|143172367|SUPERIORITY||Risk Difference (RD)|19.7|||<|0.05|TWO_SIDED|95.0|1.8|37.6||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||37.6|1.8|<0.05
71664426|NCT00261443|142841970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.353||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)||||0.353
71742561|NCT01973413|142997207|NON_INFERIORITY_OR_EQUIVALENCE|Significance level of 0.05, 90% power, required 48 nights of OCL and 48 control nights to detect a 20% improvement.|||||=|0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.037
71742562|NCT01973413|142997208|SUPERIORITY_OR_OTHER||||||=|0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||=0.340
71834299|NCT03725722|143172367|SUPERIORITY||Risk Difference (RD)|23.5|||<|0.05|TWO_SIDED|95.0|5.8|41.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||41.2|5.8|<0.05
71664427|NCT00261443|142841970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Sample||||0.204
71664428|NCT00261443|142841970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Sample||||0.435
71664429|NCT00261443|142841971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.826||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QRS||||0.826
71664430|NCT00261443|142841971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)||||0.545
71664431|NCT00261443|142841971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QRS, Phase 3||||0.372
71664432|NCT00261443|142841972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.235|TWO_SIDED|95.0|-0.07|0.27||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.27|-0.07|0.235
71742563|NCT03160898|142997218|SUPERIORITY||least squares mean treatment difference|1.61|STANDARD_ERROR_OF_MEAN|1.003||0.1095|TWO_SIDED|95.0|-0.36|3.58|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||"The statistical null hypothesis was as follows: there was no assumed dose-response relationship in percent predicted SVC change from baseline to Week 12 among all three active doses and placebo, expressed as:~H0: -5 x µ placebo - 1 x µ 150 mg twice daily + 3 x µ 300 mg twice daily + 3 x µ 450 mg twice daily = 0 where µ was the mean of the efficacy endpoint for the designated group."||3.58|-0.36|0.1095
71742564|NCT03160898|142997218|SUPERIORITY||Least squares mean difference|1.49|STANDARD_ERROR_OF_MEAN|1.291||0.2501|TWO_SIDED|95.0|-1.05|4.03|||Mixed Models Analysis|||||4.03|-1.05|0.2501
71742565|NCT03160898|142997218|SUPERIORITY||Least squares mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.29||0.1549|TWO_SIDED|95.0|-0.7|4.38|||Mixed Models Analysis|||||4.38|-0.7|0.1549
71742566|NCT03160898|142997218|SUPERIORITY||Least squares mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.274||0.1417|TWO_SIDED|95.0|-0.63|4.38|||Mixed Models Analysis|||||4.38|-0.63|0.1417
71742567|NCT03160898|142997218|SUPERIORITY||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|1.115||0.0964|TWO_SIDED|95.0|-0.33|4.05|||Mixed Models Analysis|||||4.05|-0.33|0.0964
71742568|NCT03160898|142997219|SUPERIORITY||Least squares mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.335||0.093|TWO_SIDED|95.0|-0.09|1.22|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||1.22|-0.09|0.0930
71664433|NCT00261443|142841972|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36||||0.012|TWO_SIDED|95.0|0.08|0.64||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value in Change Treatment Difference||0.64|0.08|0.012
71664434|NCT00261443|142841973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.587||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Heart Rate||||0.587
71664435|NCT00261443|142841973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)||||0.386
71664436|NCT00261443|142841973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.405||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Heart Rate, Phase 3||||0.405
71664437|NCT00261443|142841973|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253||95.0||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3||||0.253
71664438|NCT00261443|142841974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.514|TWO_SIDED|95.0|-0.12|0.23||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.23|-0.12|0.514
71664439|NCT00261443|142841974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.362|TWO_SIDED|95.0|-0.14|0.38||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.38|-0.14|0.362
71664440|NCT00261443|142841975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.904|TWO_SIDED|95.0|-0.04|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.04|0.904
71664441|NCT00261443|142841975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.222|TWO_SIDED|95.0|-0.03|0.11||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||0.11|-0.03|0.222
71742569|NCT03160898|142997219|SUPERIORITY||Least squares mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.427||0.0087|TWO_SIDED|95.0|0.29|1.97|||Mixed Models Analysis|||||1.97|0.29|0.0087
71777129|NCT02758171|143053578|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|102.33|STANDARD_DEVIATION|13.6|<|0.0001|TWO_SIDED|90.0|97.945|106.91|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||106.910|97.945|<0.0001
71742570|NCT03160898|142997219|SUPERIORITY||Least squares mean difference|0.91|STANDARD_ERROR_OF_MEAN|0.43||0.0351|TWO_SIDED|95.0|0.06|1.75|||Mixed Models Analysis|||||1.75|0.06|0.0351
71742571|NCT03160898|142997219|SUPERIORITY||Least squares mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.425||0.1642|TWO_SIDED|95.0|-0.24|1.43|||Mixed Models Analysis|||||1.43|-0.24|0.1642
71742572|NCT03160898|142997219|SUPERIORITY||Least squares mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.371||0.0435|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.0435
71742573|NCT03160898|142997220|SUPERIORITY||Slope difference|0.0276|STANDARD_ERROR_OF_MEAN|0.02734||0.3134|TWO_SIDED|95.0|-0.0261|0.0813|||Mixed Models Analysis|Analyzed by an MMRM with contrast (-5, -1, 3, 3) to reflect the assumed relationship for the 4 groups: placebo, 150, 300, and 450 mg twice daily.||||0.0813|-0.0261|0.3134
71742574|NCT03160898|142997220|SUPERIORITY||Least squares mean difference|0.0246||||0.4824|TWO_SIDED|95.0|-0.0442|0.0935|||Mixed Models Analysis|||||0.0935|-0.0442|0.4824
71742575|NCT03160898|142997220|SUPERIORITY||Least squares mean difference|0.0146||||0.6787|TWO_SIDED|95.0|-0.0544|0.0835|||Mixed Models Analysis|||||0.0835|-0.0544|0.6787
71742576|NCT03160898|142997220|SUPERIORITY||Least squares mean difference|0.0488||||0.1604|TWO_SIDED|95.0|-0.0194|0.1171|||Mixed Models Analysis|||||0.1171|-0.0194|0.1604
71742577|NCT03160898|142997220|SUPERIORITY||Least squares mean difference|0.0317||||0.2966|TWO_SIDED|95.0|-0.0279|0.0913|||Mixed Models Analysis|||||0.0913|-0.0279|0.2966
71742578|NCT01773187|142997251|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||Pre-specified||||0.0003
71742579|NCT01773187|142997252|SUPERIORITY|||||||0.2368|||||||Fisher Exact|||Pre-specified||||0.2368
71742580|NCT03678311|142997291|OTHER|The correlation between the outcome and AHI was tested by Spearman's correlation.|Spearman's correlation|0.13||||0.73|TWO_SIDED|95.0|-0.75|1.0|||Spearman's correlation|||Spearman's correlation was used to evaluate the relationship between the outcome and the apnea hypopnea index.||1.00|-0.75|0.73
71742581|NCT02936635|142997311|SUPERIORITY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.619||0.2821|TWO_SIDED|95.0|-11.035|3.23|||Mixed Models Analysis|||||3.23|-11.035|0.2821
71742582|NCT02936635|142997312|SUPERIORITY||Median Difference (Final Values)|-5.32|STANDARD_ERROR_OF_MEAN|4.242||0.2118|TWO_SIDED|95.0|-13.711|3.067|||Mixed Models Analysis|||||3.067|-13.711|0.2118
71742583|NCT02936635|142997313|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|1.205||0.6354|TWO_SIDED|95.0|-2.946|1.801|||Mixed Models Analysis|||||1.801|-2.946|0.6354
71742584|NCT02936635|142997314|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.509||0.8887|TWO_SIDED|95.0|-3.186|2.763|||Mixed Models Analysis|||||2.763|-3.186|0.8887
71742585|NCT03652181|142997329|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean QSM||||||0.033|||||||t-test, 2 sided|||||||0.033
71742586|NCT03652181|142997330|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 change in mean DCEQP||||||0.3459|||||||t-test, 2 sided|||||||0.3459
71742587|NCT03652181|142997331|EQUIVALENCE|The null hypothesis is that the year 1 change is equivalent to year 2 numbers||||||1|||||||Chi-squared|||||||1.0
71742588|NCT03573323|142997349|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742589|NCT03573323|142997350|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742590|NCT03573323|142997351|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742591|NCT03573323|142997352|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742592|NCT03573323|142997353|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742593|NCT03573323|142997354|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742594|NCT03573323|142997355|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742595|NCT03573323|142997356|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71742596|NCT03573323|142997357|SUPERIORITY|||||||0.414|||||||Cochran-Mantel-Haenszel|||||||0.414
71742597|NCT04502290|142997361|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the number of blocks after intervention will be not statistically significant.||||.04
71742598|NCT04502290|142997362|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the motor evoked potnetial after intervention will be not statistically significant.||||.02
71742599|NCT04502290|142997363|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Paired t-test was used, where null hypothesis stated that the percent change in the force after intervention will be not statistically significant.||||.04
71742600|NCT02326064|142997378|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
71742601|NCT02326064|142997379|SUPERIORITY||||||<|0.001|||||||Mac-Nemar paired Chi-2 test|||||||<0.001
71742602|NCT04317040|142997380|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.398||||0.0367|TWO_SIDED|95.0|1.02|1.918|||Log Rank||Cox-Regression Model|||1.918|1.020|0.0367
71742603|NCT04317040|142997382|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0555||||0.3281|TWO_SIDED|95.0|-0.1665|0.0555|||Chi-squared||Mantel-Haenszel method|||0.0555|-0.1665|0.3281
71742604|NCT04317040|142997383|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.558||||0.0306|TWO_SIDED|95.0|0.327|0.954|||Log Rank||Cox Regression Model|||0.954|0.327|0.0306
71742605|NCT04317040|142997384|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|0.027||||0.4491|TWO_SIDED|95.0|-0.043|0.097|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 15|Day 15||0.0970|-0.0430|0.4491
71742606|NCT04317040|142997384|OTHER|Risk difference (RD) and the associated 95% CIs were calculated based on Mantel-Haenszel method and p-value was calculated based on Chi-squared test, in accordance with the statistical analysis plan.|Risk Difference (RD)|-0.0146||||0.7512|TWO_SIDED|95.0|-0.1049|0.0756|||Chi-squared||Mantel-Haenszel method used to report all-cause mortality by Day 29|Day 29||0.0756|-0.1049|0.7512
71742607|NCT04317040|142997387|OTHER|Hazard ratio (HR) and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|1.416||||0.0311|TWO_SIDED|95.0|1.031|1.945|||Log Rank||Cox Regression model|||1.945|1.031|0.0311
71742608|NCT02366195|142997398|OTHER|||||||0.387|||||||Regression, Logistic|||||||0.387
71742609|NCT02366195|142997399|OTHER|Primary completion data.||||||0.056|||||||Regression, Logistic|||||||0.056
71742610|NCT02366195|142997399|OTHER|Final analysis data.||||||0.222|||||||Regression, Logistic|||||||0.222
71742611|NCT02366195|142997400|OTHER|Primary completion data||||||0.335|||||||Cox proportional hazards|||||||0.335
71742612|NCT02366195|142997400|OTHER|Final analysis data||||||0.597|||||||Cox proportional hazards|||||||0.597
71742613|NCT02366195|142997401|OTHER|Primary completion||||||0.82|||||||Fisher's Z transformation|||||||0.82
71742614|NCT02366195|142997401|OTHER|Final analysis data||||||0.9|||||||Fisher's Z transformation|||||||0.90
71742615|NCT02366195|142997402|OTHER|Primary completion data||||||0.66|||||||Regression, Logistic|||||||0.660
71742616|NCT02366195|142997402|OTHER|Final analysis data||||||0.881|||||||Regression, Logistic|||||||0.881
71742617|NCT02366195|142997403|OTHER|Primary completion data||||||0.974|||||||Regression, Logistic|||||||0.974
71742618|NCT02366195|142997403|OTHER|Final analysis data||||||0.612|||||||Regression, Logistic|||||||0.612
71742619|NCT02366195|142997404|OTHER|Primary completion data||||||0.626|||||||Cox proportional hazards|||||||0.626
71742620|NCT02366195|142997404|OTHER|Final analysis data||||||0.579|||||||Cox proportional hazards|||||||0.579
71742621|NCT02366195|142997405|OTHER|Primary completion data||||||0.18|||||||Pearson's correlation coefficient|||||||0.18
71742622|NCT02366195|142997405|OTHER|Final analysis data||||||0.14|||||||Pearson's correlation coefficient|||||||0.14
71742623|NCT01843023|142997522|SUPERIORITY||Mean Difference (Final Values)|0.558|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71742624|NCT01843023|142997524|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71742625|NCT00226811|142997555|SUPERIORITY_OR_OTHER||CBR rate (percentage)|7.7||||||95.0|2.9|16.0|||||Clinical benefit response rate: percent of patients with confirmed complete response, confirmed partial response or stable disease for at least 24 wks according to Response Evaluation Criteria in Solid Tumors, relative to total treated patients|||16.0|2.9|
71742626|NCT00226811|142997560|SUPERIORITY_OR_OTHER||OR rate (percentage)|2.6||||||95.0|0.3|9.0|||||Percentage of patients with confirmed complete response or confirmed partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), relative to the total number of treated patients.|||9.0|0.3|
71742627|NCT01010971|142997579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|||<|0.0001|TWO_SIDED|95.0|0.59|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.59|<0.0001
71742628|NCT01010971|142997579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|95.0|0.61|1.46||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.46|0.61|<0.0001
71742629|NCT01010971|142997580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.07|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.07|<0.0001
71742630|NCT01010971|142997580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001|TWO_SIDED|95.0|0.08|0.29|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.29|0.08|<0.0001
71742631|NCT01010971|142997581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.1444|TWO_SIDED|95.0|-0.03|0.71||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.71|-0.03|0.1444
71742632|NCT01010971|142997581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.0124|TWO_SIDED|95.0|0.15|0.89||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.89|0.15|0.0124
71742633|NCT01010971|142997582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.0124|TWO_SIDED|95.0|0.3|0.94||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.94|0.30|0.0124
71742634|NCT01010971|142997582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||||TWO_SIDED|95.0|0.33|0.95||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||||0.95|0.33|
71742635|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71742636|NCT01128426|142997641|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742637|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .99
71742638|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742639|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .20
71742640|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71742641|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
71742642|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742643|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .03
71890880|NCT03093402|143303448|SUPERIORITY||Mean Difference (Final Values)|-1.28||||0.245|TWO_SIDED|95.0|-2.64|0.09||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Pain Intensity at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was -1.1 (-2.1, -0.1).|||0.09|-2.64|0.245
71742644|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742645|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742646|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742647|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71742648|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71742649|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71742650|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742651|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71742652|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71742653|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71742654|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71742655|NCT01128426|142997641|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742656|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71742657|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742658|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71742659|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742660|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742661|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742662|NCT01128426|142997641|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742663|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71664442|NCT00261443|142841976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.808|TWO_SIDED|95.0|-0.03|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.04|-0.03|0.808
71742664|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71742665|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71742666|NCT01128426|142997641|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71777130|NCT02758171|143053579|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|107.51|STANDARD_DEVIATION|27.4||0.0027|TWO_SIDED|90.0|98.561|117.282|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||117.282|98.561|0.0027
71777131|NCT02758171|143053580|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|101.44|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|99.574|103.336|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.336|99.574|
71777132|NCT02758171|143053581|SUPERIORITY_OR_OTHER||Adjusted geometric mean (gMean) ratio|98.15|STANDARD_DEVIATION|15.2|||TWO_SIDED|90.0|93.456|103.082|||ANOVA||"The ratio \[%\] calculated as T \[FDC (10 mg Empagliflozin and 5 mg Linagliptin)\]/R \[Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets\].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.||103.082|93.456|
71777133|NCT02437383|143053594|SUPERIORITY||LSM Difference (Final Values)|-1.8||||0.414|TWO_SIDED|95.0|-6.2|2.6||P-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|Covariates for site, baseline value, sex, race, treatment, visit, a treatment\*visit interaction, and an unstructured covariance structure.||||2.6|-6.2|0.414
71777134|NCT00986830|143053652|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value of \<0.05 was considered statistically significant.|t-test, 2 sided||||A reduction in SNOT-20 score of 0.8 or more is considered clinically meaningful.|||<0.0001
71777135|NCT00986830|143053653|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
71664443|NCT00261443|142841976|SUPERIORITY_OR_OTHER_LEGACY|||||||0.771||95.0||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference||||0.771
71742667|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71742668|NCT01128426|142997641|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742669|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742670|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742671|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71777136|NCT00986830|143053654|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
71777137|NCT00986830|143053655|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
71777138|NCT00986830|143053656|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
71777139|NCT00986830|143053657|SUPERIORITY|||||||0.009||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.009
71664444|NCT00261443|142841977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01||||0.576|TWO_SIDED|95.0|-0.05|0.03||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.03|-0.05|0.576
71664445|NCT00261443|142841977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.636|TWO_SIDED|95.0|-0.05|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value treatment Difference||0.08|-0.05|0.636
71664446|NCT00261443|142841978|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774|TWO_SIDED|95.0|-0.06|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference||0.08|-0.06|0.774
71664447|NCT00261443|142841978|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.04||||0.444|TWO_SIDED|95.0|-0.06|0.14||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change, Treatment Difference||0.14|-0.06|0.444
71742672|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
71742673|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71742674|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742675|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742676|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71742677|NCT01128426|142997641|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71890881|NCT03093402|143303449|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.608|TWO_SIDED|95.0|-4.45|3.54||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of High JBT-101 - Placebo in the change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||3.54|-4.45|0.608
71664448|NCT02755649|142841992|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|16.87|42.05||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||42.05|16.87|< 0.0001
71664449|NCT02755649|142841992|SUPERIORITY||difference in percentages|33.0|||<|0.0001|TWO_SIDED|95.0|20.41|45.57||Threshold for significance at 0.05 level. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by disease severity (IGA 3 vs IGA 4) and prior Cyclosporine A (CSA) use (Yes, No).|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across 2 dose regimens. Difference is Dupilumab minus placebo. Confidence Interval (CI) calculated using normal approximation. Participants with missing values at Week 16 were categorized as non-responders at Week 16. Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated.||45.57|20.41|< 0.0001
71742678|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742679|NCT01128426|142997641|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71742680|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71742681|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742682|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742683|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742684|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71742685|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742686|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71742687|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71742688|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742689|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71742690|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
71742691|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71742692|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71742693|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742694|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71777140|NCT00986830|143053658|SUPERIORITY|||||||0.292||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||0.292
71777141|NCT00986830|143053659|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to calculate the p-values and evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 indicates statistical significance.|t-test, 2 sided|||||||<0.0001
71742695|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742696|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71742697|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71777142|NCT01453725|143053665|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|31.2|||<|0.0001|TWO_SIDED|95.0|17.5|43.6||Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level|Stratified Miettinen and Nurminen Method|||||43.6|17.5|<0.0001
71777143|NCT01453725|143053666|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|33.8|||<|0.0001|TWO_SIDED|95.0|20.4|46.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||46.1|20.4|<0.0001
71742698|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71742699|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71742700|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742701|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742702|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
71742703|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71742704|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742705|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742706|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71742707|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742708|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71742709|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
71742710|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71742711|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71742712|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.83|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.83
71742713|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71742714|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742715|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71742716|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71742717|NCT01128426|142997642|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742718|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71742719|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71742720|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742721|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742722|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71742723|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71742724|NCT01128426|142997642|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71742725|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71742726|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742727|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71742728|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71742729|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
71742730|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71742731|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71742732|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71742733|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742734|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742735|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71742736|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71742737|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71742738|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
71742739|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742740|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71742741|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742742|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742743|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742744|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71777144|NCT01453725|143053667|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|28.0|||<|0.0001|TWO_SIDED|95.0|14.4|40.6||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||40.6|14.4|<0.0001
71777145|NCT01453725|143053668|SUPERIORITY_OR_OTHER||Difference in Percent vs Placebo|15.2||||0.0136|TWO_SIDED|95.0|3.2|27.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method|||||27.1|3.2|0.0136
71777146|NCT01453725|143053669|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mann-Whitney Test|||||||<0.0001
71777147|NCT04981392|143053675|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0066|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0066
71777148|NCT04981392|143053676|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.3||0.0058|TWO_SIDED||||||Difference in adjusted % vaccinated|||||||0.0058
71777149|NCT00471146|143053726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.5436|TWO_SIDED|95.0|0.786|1.309||One-sided log-rank test at alpha = 0.025 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.309|0.786|0.5436
71777150|NCT00471146|143053727|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.5203|TWO_SIDED|95.0|0.779|1.298||One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||1.298|0.779|0.5203
71742745|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71742746|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71742747|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742748|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742749|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71777151|NCT00471146|143053728|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.2||||0.038|TWO_SIDED|95.0|1.0|10.1|||Cochran-Mantel-Haenszel|||Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).||10.1|1.0|0.038
71777152|NCT01385371|143053742|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.98|||<|0.001||95.0|-1.2|-0.4|||Wilcoxon Rank Sum Test|||||-0.4|-1.2|<0.001
71777153|NCT01385371|143053743|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.001|TWO_SIDED|95.0|-0.7|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.7|0.001
71777154|NCT01385371|143053744|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.33|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5|||Wilcoxon Rank Sum Test|||||-0.5|-1.4|<0.001
71777155|NCT01385371|143053745|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.13||||0.027||95.0|-0.2|0.0|||Wilcoxon Rank Sum Test|||||0.0|-0.2|0.027
71777156|NCT01385371|143053746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0003|TWO_SIDED|95.0|-0.73|-0.22||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.22|-0.73|0.0003
71777157|NCT01385371|143053747|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.69|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||Wilcoxon Rank Sum Test|||||-0.2|-0.9|<0.001
71777158|NCT01385371|143053748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0001|TWO_SIDED|95.0|-0.94|-0.31||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (\<18 or \>=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model|||||-0.31|-0.94|0.0001
71777159|NCT01385371|143053749|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.15||||0.644|TWO_SIDED|95.0|-0.4|0.6|||Wilcoxon Rank Sum Test|||||0.6|-0.4|0.644
71777160|NCT02478372|143053750|SUPERIORITY_OR_OTHER|||||||0.332|TWO_SIDED|||||Significance was set at \<0.01|Chi-squared|||||||0.332
71777161|NCT02955797|143053766|NON_INFERIORITY|95% confidence interval (CI) was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was greater than (\>) -10%.|Percentage difference|-2.03|||||TWO_SIDED|95.0|-5.84|1.78||||||Serogroup A||1.78|-5.84|
71777162|NCT02955797|143053766|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|12.1|||||TWO_SIDED|95.0|8.16|16.1||||||Serogroup C||16.1|8.16|
71664450|NCT02755649|142841993|SUPERIORITY||Least square (LS) mean difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-38.85|-24.3||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach to control Type-1 error rate at 0.05 across 2 dose regimens.CI w/p-value based on treatment difference(dupilumab vs placebo) of LS mean percent change using multiple imputation (MI) w/ANCOVA model w/baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-24.3|-38.85|< 0.0001
71664451|NCT02755649|142841993|SUPERIORITY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-40.42|-25.88||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue \& then imputed by MI.||-25.88|-40.42|< 0.0001
71664452|NCT02755649|142841994|SUPERIORITY||LS mean difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-35.07|-17.41||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-17.41|-35.07|< 0.0001
71742750|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71742751|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71742752|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742753|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71777163|NCT02955797|143053766|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|2.42|||||TWO_SIDED|95.0|-1.34|6.19||||||Serogroup Y||6.19|-1.34|
71777164|NCT02955797|143053766|NON_INFERIORITY|95% CI was stratified on the priming status (meningococcal vaccine naïve or primed monovalent MenC vaccination during infancy) and calculated using the Wald method (normal approximation). Weighted average of the difference over strata was calculated using the Minimal Risk weights with the null variance method. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.458|||||TWO_SIDED|95.0|-4.37|5.28||||||Serogroup W||5.28|-4.37|
71777165|NCT02955797|143053767|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.3|||||TWO_SIDED|95.0|-3.6|6.2||||||Serogroup A||6.2|-3.6|
71777166|NCT02955797|143053767|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|18.0|||||TWO_SIDED|95.0|13.6|22.8||||||Serogroup C||22.8|13.6|
71664453|NCT02755649|142841994|SUPERIORITY||LS Mean Difference]|-28.5|||<|0.0001|TWO_SIDED|95.0|-37.34|-19.68||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-19.68|-37.34|< 0.0001
71742754|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742755|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742756|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742757|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742758|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71742759|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742760|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71742761|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742762|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742763|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71742764|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71742765|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
71742766|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71742767|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71742768|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71742769|NCT01128426|142997643|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742770|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742771|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71742772|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742773|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742774|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742775|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71777167|NCT02955797|143053767|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|1.6|||||TWO_SIDED|95.0|-2.76|6.03||||||Serogroup Y||6.03|-2.76|
71777168|NCT02955797|143053767|NON_INFERIORITY|95% CI of the difference in percentages was computed using the Wilson Score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage difference|0.2|||||TWO_SIDED|95.0|-5.85|6.18||||||Serogroup W||6.18|-5.85|
71777169|NCT02955797|143053768|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an analysis of variance (ANOVA) model of log10-transformed titers.|GMT Ratio|0.819|||||TWO_SIDED|95.0|0.697|0.963||||||Serogroup A||0.963|0.697|
71777170|NCT02955797|143053768|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|7.59|||||TWO_SIDED|95.0|6.05|9.52||||||Serogroup C||9.52|6.05|
71777171|NCT02955797|143053768|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Serogroup Y||1.51|1.09|
71742776|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71742777|NCT01128426|142997643|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71742778|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742779|NCT01128426|142997644|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742780|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742781|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71742782|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
71664454|NCT02755649|142841995|SUPERIORITY||LS Mean Difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.56|-21.93||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-21.93|-35.56|< 0.0001
71664455|NCT02755649|142841995|SUPERIORITY||LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.7|-26.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-26.06|-39.7|< 0.0001
71664456|NCT02755649|142841996|SUPERIORITY||difference in percentages|26.1|||<|0.0001|TWO_SIDED|95.0|13.89|38.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||38.39|13.89|< 0.0001
71664457|NCT02755649|142841996|SUPERIORITY||difference in percentages|31.5|||<|0.0001|TWO_SIDED|95.0|19.08|43.83||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||43.83|19.08|< 0.0001
71664458|NCT02755649|142841997|SUPERIORITY||LS Mean Difference|-17.95|||<|0.0001|TWO_SIDED|95.0|-22.706|-13.197||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value is based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI||-13.197|-22.706|< 0.0001
71742783|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742784|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742785|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71742786|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742787|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742788|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742789|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71664459|NCT02755649|142841997|SUPERIORITY||LS Mean Difference|-19.66|||<|0.0001|TWO_SIDED|95.0|-24.431|-14.895||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-14.895|-24.431|< 0.0001
71664460|NCT02755649|142841998|SUPERIORITY||Difference in Percentages|25.2|||<|0.0001|TWO_SIDED|95.0|13.99|36.41||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||36.41|13.99|< 0.0001
71742790|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71742791|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71742792|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
71742793|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71742794|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71664461|NCT02755649|142841998|SUPERIORITY||Difference in Percentages|26.3|||<|0.0001|TWO_SIDED|95.0|14.95|37.65||Threshold for significance at 0.05 level|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||37.65|14.95|< 0.0001
71664462|NCT02755649|142841999|SUPERIORITY||LS Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.6|-3.04||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.04|-5.6|< 0.0001
71777172|NCT02955797|143053768|OTHER|95% CI of the ratio of post-vaccination GMTs was stratified on the priming vaccination status (meningococcal vaccine naïve or primed monovalent MenC vaccination) and calculated using an ANOVA model of log10-transformed titers.|GMT Ratio|1.32|||||TWO_SIDED|95.0|1.12|1.56||||||Serogroup W||1.56|1.12|
71834300|NCT03725722|143172367|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.0005|TWO_SIDED|95.0|17.5|53.2||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||53.2|17.5|<0.0005
71890882|NCT03093402|143303449|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.27|5.47||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Medium JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.47|-2.27|0.608
71777173|NCT02955797|143053769|OTHER||GMT Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.24||||||Serogroup A||1.24|0.85|
71777174|NCT02955797|143053769|OTHER||GMT Ratio|16.5|||||TWO_SIDED|95.0|13.4|20.4||||||Serogroup C||20.4|13.4|
71777175|NCT02955797|143053769|OTHER||GMT Ratio|1.18|||||TWO_SIDED|95.0|0.97|1.44||||||Serogroup Y||1.44|0.97|
71777176|NCT02955797|143053769|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.1|1.63||||||Serogroup W||1.63|1.1|
71777177|NCT02955797|143053770|OTHER||GMT Ratio|0.496|||||TWO_SIDED|95.0|0.367|0.672||||||Serogroup A||0.672|0.367|
71777178|NCT02955797|143053770|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|0.814|2.19||||||Serogroup C||2.19|0.814|
71777179|NCT02955797|143053770|OTHER||GMT Ratio|1.53|||||TWO_SIDED|95.0|1.15|2.04||||||Serogroup Y||2.04|1.15|
71777180|NCT02955797|143053770|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|0.944|1.75||||||Serogroup W||1.75|0.944|
71777181|NCT00543543|143053771|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.7|||<|0.0001|TWO_SIDED|95.0|80.9|99.8|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.8|80.9|<0.0001
71777182|NCT00543543|143053772|SUPERIORITY_OR_OTHER||Vaccine efficacy|97.4|||||TWO_SIDED|95.0|85.0|99.9|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||99.9|85.0|
71777183|NCT00543543|143053773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.99|1.06|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 6||1.06|0.99|<0.001
71777184|NCT00543543|143053773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.77|0.83|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 11||0.83|0.77|<0.001
71777185|NCT00543543|143053773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.96|1.03|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 16||1.03|0.96|<0.001
71777186|NCT00543543|143053773|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was \>0.67|GMT ratio|1.19|||<|0.001|TWO_SIDED|95.0|1.14|1.23|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 18||1.23|1.14|<0.001
71777187|NCT00543543|143053780|SUPERIORITY_OR_OTHER||Vaccine efficacy|96.0|||||TWO_SIDED|95.0|94.6|97.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.|||97.1|94.6|
71777188|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.38||1|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-0.8|1.000
71777189|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37||1|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.7|-0.7|1.000
71834301|NCT03725722|143172367|SUPERIORITY||Risk Difference (RD)|45.4|||<|0.0001|TWO_SIDED|95.0|28.1|62.8||Data collected after premature discont. of IMP due to COVID-19 were set to missing Week 8. Data collected after premature discont. of IMP due to reasons unrelated to COVID-19 or due to initiation of rescue med. were imputed as non-responders.|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline vIGA-AD score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative test that there is a difference||62.8|28.1|<0.0001
71890883|NCT03093402|143303449|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.608|TWO_SIDED|95.0|-2.25|5.45||This p-value is from the overall 3 degree of freedom test that simultaneously compares the mean difference in the change from baseline PROMIS Cognitive Function T-Score at Day 85 for each of the 3 JBT-101 cohorts versus placebo.|Mixed Models Analysis||Estimated mean difference of Low JBT-101 - Placebo in the mean change from baseline at Day 85. The estimated Day 85 change from baseline and 95% confidence interval for the Placebo group was 1.4 (-1.5, 4.4).|Each active JBT-101 cohort is compared to placebo.||5.45|-2.25|0.608
71890884|NCT02886702|143303465|EQUIVALENCE|90% confidence interval on the difference between the proportions to be within \[-20%, +20%\].|Risk Difference (RD)|-4.5||||||90.0|-12.6|3.6||p-value not calculated|Yates' corrected confidence interval|||||3.6|-12.6|
71890885|NCT02886702|143303465|SUPERIORITY|Last Observation Carried Forward (LOCF) for missing efficacy values||||||0.352|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.3520
71742795|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71742796|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71742797|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742798|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71742799|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742800|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742801|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71742802|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71742803|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742804|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71742805|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
71742806|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742807|NCT01128426|142997644|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742808|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.88|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.88
71742809|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742810|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71742811|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742812|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742813|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71742814|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
71742815|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71742816|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71742817|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71742818|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71777190|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.391|TWO_SIDED|95.0|-1.0|0.4|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.4|-1.0|0.391
71742819|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71742820|NCT01128426|142997644|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742821|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71742822|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
71742823|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71742824|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742825|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742826|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742827|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71742828|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742829|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71742830|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742831|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742832|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71742833|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71742834|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71742835|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742836|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71742837|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71742838|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
71742839|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742840|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742841|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
71742842|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71742843|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742844|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742845|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71742846|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71890886|NCT02886702|143303466|SUPERIORITY|||||||0.8105|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.8105
71890887|NCT02886702|143303466|SUPERIORITY|||||||0.0613|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0613
71742847|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742848|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742849|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71742850|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71777191|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.696|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.9|-0.6|0.696
71777192|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.921|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.8|-0.7|0.921
71777193|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.693|TWO_SIDED|95.0|-0.6|0.9|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.9|-0.6|0.693
71777194|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.77|TWO_SIDED|95.0|-0.7|0.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.9|-0.7|0.770
71777195|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.98||0.938|TWO_SIDED|95.0|-3.7|4.0|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.0|-3.7|0.938
71777196|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.52||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.5|-1.5|0.340
71777197|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.258|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.4|-1.6|0.258
71742851|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.09|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.09
71777198|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.49||0.381|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.5|-1.4|0.381
71777199|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.287|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||0.5|-1.6|0.287
71777200|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.42|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Relief: Intraparticipant analysis||0.6|-1.5|0.420
71777201|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53||0.227|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.4|-1.7|0.227
71777202|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.427|TWO_SIDED|95.0|-1.5|0.6|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||0.6|-1.5|0.427
71890888|NCT02886702|143303467|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||1.0000
71890889|NCT02886702|143303467|SUPERIORITY|||||||0.0712|||||||Cochran-Mantel-Haenszel|stratified by clinical site||||||0.0712
71742852|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71742853|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742854|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71664463|NCT02755649|142841999|SUPERIORITY||LS Mean Difference|-5.0|||<|0.0001|TWO_SIDED|95.0|-6.31|-3.74||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.74|-6.31|< 0.0001
71664464|NCT02755649|142842000|SUPERIORITY||LS Mean Difference|-7.1|||<|0.0001|TWO_SIDED|95.0|-8.78|-5.47||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.47|-8.78|< 0.0001
71777203|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|2.7||0.256|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||2.2|-8.4|0.256
71777204|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.62||0.198|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||2.0|-0.4|0.198
71664465|NCT02755649|142842000|SUPERIORITY||LS Mean Difference|-7.6|||<|0.0001|TWO_SIDED|95.0|-9.29|-5.97||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\])as fixed factors. Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.97|-9.29|< 0.0001
71742855|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71742856|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742857|NCT01128426|142997645|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742858|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71742859|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742860|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742861|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742862|NCT01128426|142997645|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71742863|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71742864|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742865|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742866|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71742867|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.86
71742868|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742869|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71742870|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
71742871|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71742872|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742873|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71834302|NCT03725722|143172368|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
71834303|NCT03725722|143172368|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||"vIGA-AD was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner.||||>0.05
71834304|NCT03725722|143172368|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD.|||||>|0.05||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||>0.05
71890890|NCT00885079|143303587|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Mean Difference (Final Values)|-0.9|STANDARD_DEVIATION|2.1|<|0.05|TWO_SIDED|95.0|-1.47|-0.24||An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).|t-test, 2 sided|||||-0.24|-1.47|<0.05
71742874|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71742875|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71742876|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71742877|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742878|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71742879|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
71742880|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71742881|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||1|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||1.00
71742882|NCT01128426|142997646|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742883|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
71742884|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71742885|NCT01128426|142997646|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742886|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71742887|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71742888|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742889|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71890891|NCT00885079|143303588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||<|0.05|||||||t-test, 2 sided|||||||<0.05
71742890|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742891|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71742892|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71777205|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|0.6||0.132|TWO_SIDED|95.0|-0.3|2.1|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||2.1|-0.3|0.132
71777206|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.58||0.227|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||1.8|-0.4|0.227
71777207|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.63||0.208|TWO_SIDED|95.0|-0.4|2.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||2.0|-0.4|0.208
71777208|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|0.63||0.265|TWO_SIDED|95.0|-0.5|1.9|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.9|-0.5|0.265
71777209|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.63||0.34|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||1.8|-0.6|0.340
71777210|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.64||0.347|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.9|-0.7|0.347
71777211|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|4.3|STANDARD_ERROR_OF_MEAN|3.19||0.179|TWO_SIDED|95.0|-2.0|10.6|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||10.6|-2.0|0.179
71742893|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742894|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71777212|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|Least Square (LS) Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.57||0.556|TWO_SIDED|95.0|-1.4|0.8|||Mixed Models Analysis|||Overall Opinion: Intraparticipant analysis||0.8|-1.4|0.556
71777213|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.76|TWO_SIDED|95.0|-1.2|0.9|||Mixed Models Analysis|||Vascularity: Intraparticipant analysis||0.9|-1.2|0.760
71777214|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.636|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||Pigmentation: Intraparticipant analysis||0.8|-1.3|0.636
71777215|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.774|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Thickness: Intraparticipant analysis||1.0|-1.3|0.774
71777216|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.57||0.771|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||Relief: Intraparticipant analysis||1.0|-1.3|0.771
71777217|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.468|TWO_SIDED|95.0|-1.5|0.7|||Mixed Models Analysis|||Pliability: Intraparticipant analysis||0.7|-1.5|0.468
71742895|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71742896|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71742897|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742898|NCT01128426|142997646|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742899|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71742900|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742901|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71777218|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.886|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||Surface Area: Intraparticipant analysis||1.1|-1.2|0.886
71742902|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742903|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742904|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71742905|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
71742906|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742907|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
71742908|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71742909|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71742910|NCT01128426|142997646|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742911|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71742912|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742913|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71742914|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742915|NCT01128426|142997646|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71742916|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71742917|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71742918|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71742919|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71777219|NCT01346969|143053784|OTHER|LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category.|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|2.91||0.668|TWO_SIDED|95.0|-7.0|4.5|||Mixed Models Analysis|||Composite Score: Intraparticipant analysis||4.5|-7.0|0.668
71777220|NCT00165984|143053798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.9||||0.003|TWO_SIDED|95.0|1.7|13.9|||Regression, Cox|||||13.9|1.7|0.003
71742920|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742921|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742922|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742923|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71742924|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71742925|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71742926|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71742927|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71742928|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742929|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71742930|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71742931|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
71742932|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71742933|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71742934|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71742935|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
71742936|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.91|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.91
71742937|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742938|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742939|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742940|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742941|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71742942|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742943|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71742944|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71742945|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71742946|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71742947|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742948|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742949|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742950|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71742951|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71664466|NCT02755649|142842001|SUPERIORITY||Difference in Percentages|30.1|||=|0.0002|TWO_SIDED|95.0|14.63|45.64||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||45.64|14.63|= 0.0002
71664467|NCT02755649|142842001|SUPERIORITY||Difference in Percentages|31.6|||=|0.0001|TWO_SIDED|95.0|16.11|47.05||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||47.05|16.11|= 0.0001
71664468|NCT02755649|142842002|SUPERIORITY||LS Mean Difference|-7.6|||=|0.0003|TWO_SIDED|95.0|-11.64|-3.51||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.51|-11.64|= 0.0003
71742952|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71742953|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71742954|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71742955|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71890892|NCT02630953|143303592|SUPERIORITY||Median Difference (Final Values)|-6.22||||0.24|TWO_SIDED|95.0|-41.15|28.7||Significance level was set at .05 a priori.|quantile regression|Bootstrapped standard errors (10,000 replications)||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-ups, controlling for baseline. Quantile regression models the median outcome instead of the mean, and are appropriate when data is skewed (as was the case in both self-reported and objectively measured MVPA).||28.70|-41.15|0.24
71664469|NCT02755649|142842002|SUPERIORITY||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.15|-5.95||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-5.95|-14.15|< 0.0001
71664470|NCT02755649|142842003|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0001|TWO_SIDED|95.0|-4.41|-1.43||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.43|-4.41|= 0.0001
71742956|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742957|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.8|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.80
71742958|NCT01128426|142997647|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742959|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742960|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71742961|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71742962|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71890893|NCT02630953|143303593|SUPERIORITY||Median Difference (Final Values)|7.5||||0.73|TWO_SIDED|95.0|-32.37|47.37||Significance was set at .05 a priori|quantile regression|||Using a series of quantile regression models with bootstrapped standard errors (10,000 replications) we examined the potential treatment effects on MVPA at follow-up, controlling for baseline||47.37|-32.37|0.73
71834305|NCT03725722|143172368|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline vIGA-AD score. An event was defined as the first time achieving vIGA-AD|||||<|0.001||||||The statistical test was not controlled for multiplicity|Log Rank|||Time to vIGA-AD TS was def. as time from date of first IMP applic. to first assess. of vIGA-AD TS. Subjects without baseline observation were censored at date of first IMP applic. Subjects with baseline observation not achieving vIGA-AD TS during treatment period were censored at date of last visit with a valid post-baseline assess. on or prior to date of discont. of IMP or initiation of rescue med, whichever occurred first. Subjects affected by COVID-19 pandemic were handled in the same manner||||<0.001
71664471|NCT02755649|142842003|SUPERIORITY||LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.38|-2.4||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-2.4|-5.38|< 0.0001
71834306|NCT01600014|143172369|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.44||||0.001|TWO_SIDED|95.0|1.32|4.51||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||4.51|1.32|0.001
71834307|NCT01600014|143172369|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.37||||0.013|TWO_SIDED|95.0|1.07|5.25||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and week of randomisation||The analysis type was superiority between groups. In total 62 subjects were included||5.25|1.07|0.013
71834308|NCT01600014|143172370|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.41||||0.016|TWO_SIDED|95.0|1.1|17.62||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included||17.62|1.10|0.016
71834309|NCT01600014|143172370|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.24||||0.1|TWO_SIDED|95.0|0.78|6.47||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 62 subjects were included||6.47|0.78|0.10
71834310|NCT01600014|143172370|SUPERIORITY_OR_OTHER_LEGACY||Percent cleared subjects|50.0|||||TWO_SIDED|95.0|44.0|56.1|||||Estimation based on completers only.|Subjects randomised to vehicle were not included in the estimate of the overall clearance rate for the repeat-use regimen, from last treatment throught to Month 12. Instead, the subjects randomised to ingenol mebutate were given higher weights to reflect the hypothetical scenario where all randomised subjects were given active treatment during the repeat use cycle||56.1|44.0|
71890894|NCT02630953|143303594|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.035|>|0.06|TWO_SIDED|||||Significance level set at .05 a priori|Regression, Linear|||Using a series of generalized linear models with identity link, we examined treatment effects on biomarkers at 6 months controlling for baseline and potential confounders.||||>.06
71742963|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71742964|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71742965|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71834311|NCT01600014|143172371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.38|-0.38||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using baseline observation carried forward (BOCF) as the imputation method.|The analysis type was superiority between groups. In total 141 subjects were included||-0.38|-1.38|<0.001
71834312|NCT01600014|143172371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.01|||<|0.001|TWO_SIDED|95.0|-1.52|-0.51||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Sensitivity analysis using complete cases|Sensitivity analysis using complete cases|The analysis type was superiority between groups. In total 141 subjects were included||-0.51|-1.52|<0.001
71834313|NCT01600014|143172371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.69||||0.008|TWO_SIDED|95.0|-1.19|-0.19||Formal statistical significance could not be established because of the closed test procedure where the first secondary endpoint tested (12 months clearance) did not reach statistical significance in the recurrent subgroup|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using BOCF as the imputation method, the difference in the adjusted mean AK count between the ingenol mebutate and vehicle groups|The analysis type was superiority between groups. In total 62 subjects were included||-0.19|-1.19|0.008
71834314|NCT02975505|143172373|SUPERIORITY||beta|11.7|||<|0.05|TWO_SIDED|95.0|7.5|16.0|||Mixed Models Analysis|||||16|7.5|<0.05
71742966|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71742967|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71742968|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
71742969|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
71742970|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742971|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71742972|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71742973|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71742974|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71742975|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71834315|NCT02975505|143172376|SUPERIORITY||beta|12.5||||0.05|TWO_SIDED|95.0|8.0|16.0|||Mixed Models Analysis|||||16|8|0.05
71742976|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742977|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71742978|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71777221|NCT02130024|143053885|OTHER||Treatment Effect|0.08||||0.236|TWO_SIDED|95.0|-0.05|0.21|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.21|-0.05|0.236
71742979|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.9|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.90
71742980|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71742981|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742982|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71742983|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742984|NCT01128426|142997648|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71742985|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742986|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71742987|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71742988|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
71742989|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71777222|NCT02130024|143053886|OTHER||Treatment Effect|0.02||||0.769|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject||||0.15|-0.11|0.769
71777223|NCT02130024|143053887|OTHER||Odds Ratio (OR)|0.84||||0.586|TWO_SIDED|95.0|0.44|1.59|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Baseline to Month 12 Analysis||1.59|0.44|0.586
71834316|NCT03661359|143172381|OTHER|||||||0.727||||||correlation is significant at the 0.05 level (2 tailed)|pearson correlation|||Correlation between patient satisfaction and domains at risk.||||.727
71834317|NCT03661359|143172383|OTHER|||||||0.002||||||correlation is significant at the 0.01 level 2 tailed|pearson correlation|||correlation between physical quality of life and mental of life||||0.002
71834318|NCT03661359|143172385|OTHER|||||||0.727|TWO_SIDED|0.05|||||pearson correlation|||||||0.727
71834319|NCT05768373|143172426|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-3.4|4.0|||||The difference is 3M Clinpro minus 3M Vanish.|||4.0|-3.4|
71834320|NCT05768373|143172427|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.6|5.3|||||The difference is 3M Clinpro minus 3M Vanish.|||5.3|-2.6|
71664472|NCT02755649|142842004|SUPERIORITY||Difference in Percentages|29.5|||<|0.0001|TWO_SIDED|95.0|17.1|41.96||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||41.96|17.1|< 0.0001
71742990|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742991|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71742992|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742993|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71742994|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71742995|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71742996|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742997|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71742998|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71742999|NCT01128426|142997648|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743000|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71834321|NCT05768373|143172428|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-3.2|6.7|||||The difference is 3M Clinpro minus 3M Vanish.|||6.7|-3.2|
71743001|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71743002|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71743003|NCT01128426|142997649|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71743004|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743005|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71743006|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743007|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71743008|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71743009|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
71743010|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71743011|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.39|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.39
71743012|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71743013|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71743014|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71834322|NCT05768373|143172429|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.0|7.4|||||The difference is 3M Clinpro minus 3M Vanish.|||7.4|-3.0|
71834323|NCT05768373|143172430|NON_INFERIORITY|This study used a non-inferiority margin of 15 mm.|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-4.4|8.2|||||The difference is 3M Clinpro minus 3M Vanish.|||8.2|-4.4|
71743015|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71743016|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71743017|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71743018|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743019|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
71743020|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.71|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.71
71777224|NCT02130024|143053887|OTHER||Odds Ratio (OR)|2.27||||0.11|TWO_SIDED|95.0|0.83|6.22|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Month 12 to Month 24 Analysis||6.22|0.83|0.110
71777225|NCT02130024|143053887|OTHER||Odds Ratio (OR)|1.19||||0.554|TWO_SIDED|95.0|0.67|2.09|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment||Baseline to Month 24 Analysis||2.09|0.67|0.554
71777226|NCT02130024|143053888|OTHER||Treatment Effect|0.99||||0.733|TWO_SIDED|95.0|0.95|1.04|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to \<Month 12 Analysis||1.04|0.95|0.733
71777227|NCT02130024|143053888|OTHER||Treatment Effect|1.01||||0.745|TWO_SIDED|95.0|0.95|1.08|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to Month 24 Analysis||1.08|0.95|0.745
71743021|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
71743022|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
71743023|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.58|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.58
71743024|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71743025|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71743026|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743027|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743028|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743029|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743030|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743031|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71777228|NCT02130024|143053889|OTHER||Treatment Effect|2.32||||0.079|TWO_SIDED|95.0|-0.27|4.92|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||4.92|-0.27|0.079
71777229|NCT02130024|143053889|OTHER||Treatment Effect|1.95||||0.151|TWO_SIDED|95.0|-0.71|4.61|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||4.61|-0.71|0.151
71777230|NCT02130024|143053890|OTHER||Treatment Effect|10.12||||0.294|TWO_SIDED|95.0|-8.82|29.06|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis||29.06|-8.82|0.294
71777231|NCT02130024|143053890|OTHER||Treatment Effect|11.86||||0.225|TWO_SIDED|95.0|-7.35|31.07|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis||31.07|-7.35|0.225
71777232|NCT02130024|143053891|OTHER||Odds Ratio (OR)|0.83||||0.461|TWO_SIDED|95.0|0.51|1.35|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 2 Analysis||1.35|0.51|0.461
71743032|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743033|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71743034|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743035|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.35|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.35
71743036|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743037|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.3|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.30
71743038|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.34
71743039|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743040|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71743041|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743042|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743043|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743044|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71743045|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71743046|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71743047|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.76|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.76
71743048|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
71743049|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743050|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743051|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743052|NCT01128426|142997649|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743053|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0 .63
71743054|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71743055|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743056|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.6|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.60
71743057|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71743058|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743059|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71777233|NCT02130024|143053891|OTHER||Odds Ratio (OR)|0.72||||0.215|TWO_SIDED|95.0|0.44|1.21|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 12 Analysis||1.21|0.44|0.215
71664473|NCT02755649|142842004|SUPERIORITY||Difference in Percentages|40.4|||<|0.0001|TWO_SIDED|95.0|28.24|52.61||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||52.61|28.24|< 0.0001
71743060|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71743061|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743062|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.11|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.11
71743063|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71743064|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743065|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71743066|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743067|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71743068|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71743069|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.36|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.36
71743070|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71743071|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743072|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
71743073|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.75|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.75
71777234|NCT02130024|143053891|OTHER||Odds Ratio (OR)|0.87||||0.616|TWO_SIDED|95.0|0.51|1.48|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 24 Analysis||1.48|0.51|0.616
71777235|NCT02130024|143053892|OTHER||Odds Ratio (OR)|1.05||||0.891|TWO_SIDED|95.0|0.53|2.08|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||2.08|0.53|0.891
71664474|NCT02755649|142842005|SUPERIORITY||LS Mean Difference|-24.3|||<|0.0001|TWO_SIDED|95.0|-31.63|-16.88||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab group vs. placebo)of LS mean percent change using MI with ANCOVA with baseline measurement as covariate \& treatment,randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use\[Yes,No\])as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-16.88|-31.63|< 0.0001
71743074|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743075|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71743076|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743077|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743078|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71743079|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71743080|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743081|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71777236|NCT02130024|143053892|OTHER||Odds Ratio (OR)|1.61||||0.206|TWO_SIDED|95.0|0.77|3.35|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||3.35|0.77|0.206
71743082|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71743083|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
71777237|NCT02130024|143053893|OTHER||Odds Ratio (OR)|1.63||||0.46|TWO_SIDED|95.0|0.45|5.93|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis||5.93|0.45|0.460
71777238|NCT02130024|143053893|OTHER||Odds Ratio (OR)|0.94||||0.913|TWO_SIDED|95.0|0.3|2.9|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis||2.90|0.30|0.913
71777239|NCT02130024|143053895|OTHER||Treatment Effect|27.2|||<|0.001|TWO_SIDED|95.0|21.44|32.95|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 5 Analysis||32.95|21.44|<0.001
71777240|NCT02130024|143053895|OTHER||Treatment Effect|28.88|||<|0.001|TWO_SIDED|95.0|23.08|34.68|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 9 Analysis||34.68|23.08|<0.001
71890895|NCT01707992|143303646|SUPERIORITY||Hazard Ratio (HR)|0.937|||=|0.7057|TWO_SIDED|95.0|0.668|1.313||Threshold for significance at 0.05 level.|Cox proportional hazards model|||The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to \[\<=\] 4 or greater than \[\>\] 4), country/geographical region (CGR), categorical age at baseline (\<=38 or \>38), and T2 volume at baseline were included as covariates in the model.||1.313|0.668|= 0.7057
71743084|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.84|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.84
71743085|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
71743086|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743087|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71743088|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743089|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71777241|NCT02484690|143053912|SUPERIORITY||Difference in Least Squares Means|1.57||||0.5244|TWO_SIDED|80.0|-1.6|4.74||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||4.74|-1.60|0.5244
71777242|NCT02484690|143053912|SUPERIORITY||Difference in Least Squares Means|-1.59||||0.5308|TWO_SIDED|80.0|-4.86|1.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.67|-4.86|0.5308
71777243|NCT02484690|143053912|SUPERIORITY||Difference in Least Squares Means|-1.51||||0.5309|TWO_SIDED|80.0|-4.62|1.59||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.59|-4.62|0.5309
71743090|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71743091|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743092|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743093|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71743094|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71743095|NCT01128426|142997650|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71743096|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743097|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.77|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.77
71743098|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71890896|NCT04551014|143303664|NON_INFERIORITY|For polypectomy without submucosal injection of EverLiftTM to be considered non-inferior, we calculated that 115 polyps were needed in each group to achieve an alpha value of 0.05, power of 90%, and non-inferiority margin of -10%.||||||0.424|||||||t-test, 2 sided|||||||0.424
71743099|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
71743100|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743101|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71743102|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743103|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743104|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743105|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
71743106|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71743107|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71743108|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743109|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71743110|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743111|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71743112|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71743113|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71743114|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71743115|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71743116|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743117|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71743118|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71743119|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71890897|NCT04551014|143303665|SUPERIORITY||||||<|0.0001||||||P-value of \<0.05 was considered statistically significant.|t-test, 2 sided|||||||<0.0001
71890898|NCT04551014|143303666|SUPERIORITY|||||||0.697||||||P-value of \<0.05 was considered statistically significant.|Chi-squared|||||||0.697
71890899|NCT00891202|143303668|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-30.03|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|-36.82|-23.24|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model fitted with treatment and baseline spleen severity (low spleen severity: spleen volume less than or equal to \[\<=\] 20 multiples of normal spleen volume, high spleen severity: spleen volume greater than \[\>\] 20 multiples of normal spleen volume).||-23.24|-36.82|<0.0001
71743120|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71743121|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71777244|NCT02484690|143053913|SUPERIORITY||Difference in Least Squares Means|-1.68||||0.3034|TWO_SIDED|80.0|-3.77|0.42||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that the Arm E mean was different from Arm A mean.||0.42|-3.77|0.3034
71890900|NCT04108429|143303677|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.830
71743122|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743123|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743124|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
71743125|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743126|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.55|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.55
71743127|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71743128|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71743129|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
71743130|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743131|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71743132|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743133|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743134|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.64|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.64
71743135|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
71743136|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
71743137|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743138|NCT01128426|142997651|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743139|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71743140|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
71743141|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.||||0.13
71743142|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71743143|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71743144|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71890901|NCT04108429|143303678|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||generalized linear mixed model - this analysis accounts for repeated measures from each participant over the course of Weeks 1, 2, 4, 6 and 8||||.759
71664475|NCT02755649|142842005|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|95.0|-33.49|-18.86||Threshold for significance at 0.05 level.|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata (disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-18.86|-33.49|< 0.0001
71664476|NCT02755649|142842006|SUPERIORITY||LS Mean Difference|-9.7|||=|0.0017|TWO_SIDED|95.0|-15.8|-3.66||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens. CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-3.66|-15.8|= 0.0017
71664477|NCT02755649|142842006|SUPERIORITY||LS Mean Difference|-7.2|||=|0.0214|TWO_SIDED|95.0|-13.31|-1.06||Threshold for significance at 0.05 level|ANCOVA|||Hierarchical testing approach was used to control Type-1 error rate at 0.05 across 2 dose regimens.CI with p-value based on treatment difference(dupilumab vs. placebo) of LS mean percent change using MI with ANCOVA model with baseline measurement as covariate \& treatment, randomization strata(disease severity\[IGA 3 vs IGA 4\] \& prior CSA use \[Yes,No\]) as fixed factors.Efficacy data from participants who received rescue treatment were set to missing after timepoint of rescue, then imputed by MI.||-1.06|-13.31|= 0.0214
71664478|NCT02755649|142842007|SUPERIORITY||Difference in Percentages|-4.7|||=|0.1486|TWO_SIDED|95.0|-10.97|1.58|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||1.58|-10.97|= 0.1486
71664479|NCT02755649|142842007|SUPERIORITY||Difference in Percentages|-6.5|||=|0.0319|TWO_SIDED|95.0|-12.27|-0.65|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||-0.65|-12.27|= 0.0319
71834324|NCT03821844|143172441|SUPERIORITY||marginal interaction effect|1.33|STANDARD_ERROR_OF_MEAN|1.38|<|0.05|TWO_SIDED|95.0|-1.37|4.03|||Differences-in-Differences regression||||"Fixed effects: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Scale (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|4.03|-1.37|< 0.05
71664480|NCT02755649|142842008|SUPERIORITY||difference in percentages|0.0|||=|0.9829|TWO_SIDED|95.0|-3.6|3.53|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.53|-3.6|= 0.9829
71664481|NCT02755649|142842008|SUPERIORITY||difference in percentages|0.0|||=|1|TWO_SIDED|95.0|-3.6|3.63|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.63|-3.6|= 1
71664482|NCT02755649|142842009|SUPERIORITY||difference in percentages|0.9|||=|0.5619|TWO_SIDED|95.0|-2.19|3.97|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||3.97|-2.19|= 0.5619
71664483|NCT02755649|142842009|SUPERIORITY||difference in percentages|-0.9|||=|0.3241|TWO_SIDED|95.0|-2.73|0.88|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||0.88|-2.73|= 0.3241
71664484|NCT02755649|142842010|SUPERIORITY||difference in percentages|-0.4|||=|0.9518|TWO_SIDED|95.0|-12.6|11.9|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||11.9|-12.6|= 0.9518
71743145|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743146|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743147|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71743148|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71743149|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.15|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.15
71743150|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743151|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71777245|NCT02484690|143053914|SUPERIORITY||Difference in Least Squares Means|5.63||||0.5527|TWO_SIDED|80.0|-6.52|17.77||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||17.77|-6.52|0.5527
71777246|NCT02484690|143053914|SUPERIORITY||Difference in Least Squares Means|-3.09||||0.7382|TWO_SIDED|80.0|-14.95|8.76||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||8.76|-14.95|0.7382
71777247|NCT02484690|143053914|SUPERIORITY||Difference in Least Squares Means|-7.32||||0.3932|TWO_SIDED|80.0|-18.32|3.67||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||3.67|-18.32|0.3932
71777248|NCT02484690|143053915|SUPERIORITY||Difference in Percentage of Participants|-5.71||||0.2328|TWO_SIDED|80.0|-10.74|-0.69||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||-0.69|-10.74|0.2328
71777249|NCT02484690|143053916|SUPERIORITY||Difference in Least Squares Means|-0.52||||0.9581|TWO_SIDED|80.0|-13.26|12.22||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||12.22|-13.26|0.9581
71743152|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743153|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71743154|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71743155|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71743156|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71743157|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71743158|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71743159|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.62|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.62
71890902|NCT04108429|143303679|SUPERIORITY|||||||0.275|||||||Simulation Modeling Analysis (SMA) for T|||Counseling center utilization data were examined using Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in utilization between the pre-implementation and implementation phases. SMA evaluates the statistical significance of between-phase changes in data streams and also accounts for the presence of autocorrelation (the non-independence of data points in time-series data streams).||||.275
71743160|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71777250|NCT02484690|143053916|SUPERIORITY||Difference in Least Squares Means|-10.08||||0.3166|TWO_SIDED|80.0|-22.99|2.82||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.82|-22.99|0.3166
71777251|NCT02484690|143053916|SUPERIORITY||Difference in Least Squares Means|-7.68||||0.4244|TWO_SIDED|80.0|-20.01|4.64||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||4.64|-20.01|0.4244
71834325|NCT03821844|143172442|SUPERIORITY||marginal interaction effect|0.06|||<|0.05|TWO_SIDED|95.0|0.03|0.09|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||"The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models. All models adjust for resident baseline covariates, an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. The reference category for the multinomial model for each outcome is None. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction."|0.09|0.03|< 0.05
71743161|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71743162|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71743163|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71743164|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743165|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743166|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743167|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71743168|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.12
71743169|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743170|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743171|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
71743172|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.38|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.38
71743173|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.78
71743174|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.65|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.65
71743175|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71743176|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71743177|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.81
71743178|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743179|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71890903|NCT04108429|143303681|SUPERIORITY|generalized linear mixed model||||||0.002|||||||Mixed Models Analysis|||||||.002
71890904|NCT04108429|143303682|SUPERIORITY|||||||0.489|||||||Mixed Models Analysis|||generalized linear mixed model||||.489
71890905|NCT04108429|143303683|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||generalized linear mixed model||||.001
71743180|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743181|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71743182|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.99
71777252|NCT02484690|143053917|SUPERIORITY||Difference in Percentage of Participants|-6.64||||0.5586|TWO_SIDED|80.0|-18.6|5.32||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||5.32|-18.60|0.5586
71777253|NCT02484690|143053918|SUPERIORITY||Difference in Least Squares Means|1.0||||0.8536|TWO_SIDED|80.0|-5.93|7.93||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||7.93|-5.93|0.8536
71777254|NCT02484690|143053918|SUPERIORITY||Difference in Least Squares Means|8.14||||0.2303|TWO_SIDED|80.0|-0.56|16.83||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||16.83|-0.56|0.2303
71743183|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743184|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71743185|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.97
71743186|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.19|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.19
71743187|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.25
71743188|NCT01128426|142997652|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743189|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743190|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743191|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71743192|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71743193|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.26|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.26
71743194|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71743195|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71743196|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.2|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.20
71743197|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71743198|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71743199|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.1|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.10
71743200|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71743201|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743202|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71743203|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71743204|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
71743205|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.79|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.79
71743206|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
71743207|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.92|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.92
71743208|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71777255|NCT02484690|143053918|SUPERIORITY||Difference in Least Squares Means|1.08||||0.8406|TWO_SIDED|80.0|-5.79|7.95||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Generalized Estimating Equations Model|Categorical covariates: treatment group, visit, and visit by treatment group interaction. An AR(1) covariance structure was also used.|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||7.95|-5.79|0.8406
71777256|NCT02484690|143053919|SUPERIORITY||Difference in Percentage of Participants|-0.77||||1|TWO_SIDED|80.0|-11.23|9.68||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Fisher Exact||The difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||9.68|-11.23|1.0000
71743209|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743210|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.4|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.40
71777257|NCT02484690|143053920|SUPERIORITY||Difference in Least Squares Means|12.65||||0.3798|TWO_SIDED|80.0|-5.81|31.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||31.11|-5.81|0.3798
71743211|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71743212|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.82|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.82
71743213|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743214|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743215|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71743216|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71743217|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71743218|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743219|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743220|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71743221|NCT01128426|142997653|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71743222|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71743223|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71664485|NCT02755649|142842010|SUPERIORITY||difference in percentages|2.5|||=|0.6833|TWO_SIDED|95.0|-9.64|14.68|||Cochran-Mantel-Haenszel|||A hierarchical testing approach was used to control Type-1 error at 0.05 across the 2 dose regimens. Difference is dupilumab minus placebo. CI calculated using normal approximation. P-values were derived by CMH test stratified by disease severity (IGA 3 vs IGA 4) and prior CSA use (Yes,No). Participants who used rescue treatment were categorized as non-responders from time rescue treatment was initiated. Participants with missing values at Week 16 were categorized as non-responders at Week 16.||14.68|-9.64|= 0.6833
71743224|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.33|||||||mid-p exact binomial method]|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.33
71743225|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.59|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.59
71777258|NCT02484690|143053920|SUPERIORITY||Difference in Least Squares Means|0.88||||0.9529|TWO_SIDED|80.0|-18.3|20.03||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||20.03|-18.3|0.9529
71743226|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743227|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743228|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71743229|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71777259|NCT02484690|143053920|SUPERIORITY||Difference in Least Squares Means|32.81||||0.0208|TWO_SIDED|80.0|14.65|50.96||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||50.96|14.65|0.0208
71777260|NCT02484690|143053921|SUPERIORITY||Difference in Least Squares Means|-6.35||||0.5185|TWO_SIDED|80.0|-19.0|6.27||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: FCPT at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||6.27|-19.0|0.5185
71777261|NCT02484690|143053922|SUPERIORITY||Difference in Least Squares Means|19.45||||0.1624|TWO_SIDED|80.0|1.61|37.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||37.29|1.61|0.1624
71664486|NCT02089659|142842019|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.72|1.35|||||Moderate hepatic insufficiency / Healthy controls|||1.35|0.72|
71664487|NCT02089659|142842020|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.66|1.24|||||Moderate hepatic insufficiency / Healthy controls|||1.24|0.66|
71743230|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743231|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71743232|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743233|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71664488|NCT02089659|142842021|OTHER||Geometric Mean Ratio|0.93|||||TWO_SIDED|90.0|0.74|1.18|||||Moderate hepatic insufficiency / Healthy controls|||1.18|0.74|
71664489|NCT02089659|142842022|OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.74|1.33|||||Moderate hepatic insufficiency / Healthy controls|||1.33|0.74|
71664490|NCT02657928|142842027|SUPERIORITY|||||||0.5004|||||||Log Rank|||||||0.5004
71743234|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743235|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71743236|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743237|NCT01128426|142997653|SUPERIORITY_OR_OTHER|||||||0.94|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.94
71743238|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.56|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.56
71743239|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
71743240|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743241|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71743242|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71777262|NCT02484690|143053922|SUPERIORITY||Difference in Least Squares Means|2.79||||0.8475|TWO_SIDED|80.0|-15.8|21.37||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||21.37|-15.8|0.8475
71777263|NCT02484690|143053922|SUPERIORITY||Difference in Least Squares Means|28.52||||0.0381|TWO_SIDED|80.0|10.93|46.11||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||46.11|10.93|0.0381
71890906|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.99||||0.8918|TWO_SIDED|95.0|-15.5|13.52|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||13.52|-15.50|0.8918
71743243|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71777264|NCT02484690|143053923|SUPERIORITY||Difference in Least Squares Means|-14.4||||0.2089|TWO_SIDED|80.0|-29.1|0.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CST at BL; Unstructured cov|The mean difference was calculated as Arm E minus Arm A.|The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.||0.29|-29.1|0.2089
71890907|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.89||||0.5183|TWO_SIDED|95.0|-19.91|10.14|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.14|-19.91|0.5183
71743244|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743245|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.32|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.32
71743246|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71664491|NCT02657928|142842028|SUPERIORITY|||||||0.9127|||||||Log Rank|||||||0.9127
71743247|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.41
71743248|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71743249|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
71743250|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.43|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.43
71743251|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.50
71743252|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.51|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.51
71777265|NCT02484690|143053926|SUPERIORITY||Difference in Least Squares Means|-0.4||||0.6717|TWO_SIDED|80.0|-1.61|0.81||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.81|-1.61|0.6717
71777266|NCT02484690|143053926|SUPERIORITY||Difference in Least Squares Means|0.23||||0.8131|TWO_SIDED|80.0|-1.01|1.47||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||1.47|-1.01|0.8131
71777267|NCT02484690|143053926|SUPERIORITY||Difference in Least Squares Means|0.11||||0.9069|TWO_SIDED|80.0|-1.07|1.29||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between each of the treatment groups (Arms B, C, or D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arms B, C, or D means were different from Arm A mean.||1.29|-1.07|0.9069
71777268|NCT02484690|143053928|SUPERIORITY||Difference in Least Squares Means|-0.96||||0.3189|TWO_SIDED|80.0|-2.2|0.28||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.28|-2.20|0.3189
71777269|NCT02484690|143053928|SUPERIORITY||Difference in Least Squares Means|1.22||||0.2256|TWO_SIDED|80.0|-0.07|2.52||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.52|-0.07|0.2256
71777270|NCT02484690|143053928|SUPERIORITY||Difference in Least Squares Means|0.35||||0.7086|TWO_SIDED|80.0|-0.86|1.57||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: CNV at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.57|-0.86|0.7086
71777271|NCT02484690|143053930|SUPERIORITY||Difference in Least Squares Means|-0.78||||0.4353|TWO_SIDED|80.0|-2.07|0.51||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm B minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.||0.51|-2.07|0.4353
71777272|NCT02484690|143053930|SUPERIORITY||Difference in Least Squares Means|1.45||||0.1652|TWO_SIDED|80.0|0.11|2.78||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm C minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.||2.78|0.11|0.1652
71777273|NCT02484690|143053930|SUPERIORITY||Difference in Least Squares Means|0.5||||0.61111|TWO_SIDED|80.0|-0.76|1.75||The threshold for statistical significance was an unadjusted 2-sided p-value \<0.2. There was no formal correction for multiple comparisons.|Mixed Model for Repeated Measures|Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, \& visit by treatment group; Continuous cov: leak at BL; Unstructured cov|The mean difference was calculated as Arm D minus Arm A.|The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.||1.75|-0.76|0.61111
71777274|NCT04916769|143053985|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of ajusted geometric means|106.27|||||TWO_SIDED|90.0|97.76|115.53||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.53|97.76|
71777275|NCT04916769|143053985|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|101.93|||||TWO_SIDED|90.0|93.97|110.56||||||Natural logarithm-transformed bosutinib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.56|93.97|
71777276|NCT04916769|143053986|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|96.82|||||TWO_SIDED|90.0|86.37|108.53||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||108.53|86.37|
71777277|NCT04916769|143053986|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|95.39|||||TWO_SIDED|90.0|85.34|106.61||||||Natural logarithm-transformed bosutinib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||106.61|85.34|
71777278|NCT04916769|143053987|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|106.23|||||TWO_SIDED|90.0|97.54|115.68||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + applesauce 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||115.68|97.54|
71777279|NCT04916769|143053987|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages.|ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|93.95|110.91||||||Natural logarithm-transformed bosutinib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Bosutinib 500 mg capsule contents + yogurt 45 mL \[Test\] - Bosutinib 500 mg intact capsule \[Reference\]) and corresponding 90% CIs were obtained from the model.||110.91|93.95|
71777280|NCT03507400|143054033|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71777281|NCT03507400|143054033|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||pooled comparison of the participants of the non-waiting list and the waiting list before and after Introvision||||0.003
71777282|NCT03507400|143054035|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71777283|NCT03507400|143054036|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.003
71777284|NCT03507400|143054037|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
71777285|NCT03507400|143054038|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon paired test||||||0.001
71777286|NCT03507400|143054042|SUPERIORITY|Wilcoxon paired test||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71777287|NCT03507400|143054042|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71777288|NCT03507400|143054042|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71777289|NCT04195906|143054069|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.328||0.877|TWO_SIDED|96.0|-2.46|3.0||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline BWAT-CUA score and visit by randomized treatment interaction.|MMRM|MMRM=Mixed model for repeated measures Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||3.00|-2.46|0.877
71777290|NCT04195906|143054070|SUPERIORITY||Least Squares Mean Difference|11.49|STANDARD_ERROR_OF_MEAN|7.93||0.146|TWO_SIDED|96.0|-4.8|27.78||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||27.78|-4.80|0.146
71777291|NCT04195906|143054071|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.237||0.706|TWO_SIDED|96.0|-0.38|0.56||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||0.56|-0.38|0.706
71777292|NCT04195906|143054072|SUPERIORITY||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|2.63||0.995|TWO_SIDED|96.0|-5.27|5.24||The MMRM model includes fixed effect terms for randomized treatment, visit, baseline sodium thiosulfate use, baseline Pain VAS and visit by randomized treatment interaction.|MMRM|MMRM: mixed model repeated measures. Participant is fitted as random effect and an unstructured variance-covariance matrix is used.||||5.24|-5.27|0.995
71777293|NCT04195906|143054073|SUPERIORITY||Odds Ratio, log|1.54|STANDARD_ERROR_OF_MEAN|0.498||0.384|TWO_SIDED|95.0|0.58|4.09||This model includes the stratification factor sodium thiosulfate use at baseline and the treatment as covariates|Regression, Logistic|As there is only a measure post-baseline, a logistic regression model was run instead of a generalized estimating equations model.|The odds ratio displayed is the odds ratio of having an improved result of SNF472 versus Placebo. The results 'Worsened', 'Equal', and 'Missing' are combined in one category and it is the reference for the odds ratio calculation.|||4.09|0.58|0.384
71777294|NCT04195906|143054074|SUPERIORITY||Difference in slopes between arms|0.57|STANDARD_ERROR_OF_MEAN|0.68||0.406|TWO_SIDED|95.0|-0.79|1.93||MMRM model includes fixed effect terms for randomized treatment, continuous variables maintenance opioid dose, Week (1 to 12) and Week by randomized treatment interaction. The random coefficients are the intercept and Week as a continuous variable.|MMRM|MMRM: mixed model repeated measures. An unstructured variance-covariance matrix is used||||1.93|-0.79|0.406
71777295|NCT00546104|143054077|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|9.0||0.3|TWO_SIDED|95.0|-30.0|9.0||The p-value is from a paired t-test to test the null hypothesis the mean relative change in Src from baseline to 4 weeks is equal to zero.|t-test, 2 sided|||The median change in SRC from baseline to 4 weeks was estimated.||9|-30|0.3
71777296|NCT00546104|143054078|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.3|TWO_SIDED|95.0|-0.3|0.1|||t-test, 1 sided|||||.10|-.30|0.3
71777297|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Diphtheria Toxin \>=0.1 IU/mL||3.95|-3.99|<0.001
71777298|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Tetanus Toxin \>=0.01 IU/mL||3.95|-3.99|<0.001
71777299|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis Toxin \>=10 EU/mL||3.95|-3.99|<0.001
71777300|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis FHA \>=10 EU/mL||3.95|-3.99|<0.001
71777301|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 1 NA \>=8||3.95|-3.99|<0.001
71777302|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 2 NA \>=8||3.95|-3.99|<0.001
71777303|NCT01926015|143054156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference \>=10%, is \>=-0.10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 3 NA \>=8||3.95|-3.99|<0.001
71777304|NCT01364649|143054169|SUPERIORITY_OR_OTHER||LS mean difference|2.2|STANDARD_ERROR_OF_MEAN|0.9||0.013|TWO_SIDED|95.0|0.48|4.02|||Mixed Model Repeated Measurements|The primary analysis was performed by using observed case data only.||||4.02|0.48|0.013
71777305|NCT03270644|143054172|OTHER||Difference of LSMeans|-5.45|||||TWO_SIDED|90.0|-7.27|-3.64||||||Mean hourly HR was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-3.64|-7.27|
71777306|NCT03270644|143054173|OTHER||Ratio of Geometric LSMeans|0.884|||||TWO_SIDED|90.0|0.832|0.939||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||0.939|0.832|
71777307|NCT03270644|143054174|OTHER||Ratio of Geometric LSMeans|0.958|||||TWO_SIDED|90.0|0.917|1.0||||||Ratio of geometric LSMeans of Cmax used a mixed-effects repeated measures model adjusted for fixed effects for treatment, time point, time point by treatment, and random effect for subjects.||1.00|0.917|
71777308|NCT03270644|143054175|OTHER||Ratio of Geometric LSMeans|1.01|||||TWO_SIDED|90.0|0.967|1.04||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.04|0.967|
71777309|NCT03270644|143054176|OTHER||Ratio of Geometric LSMeans|0.999|||||TWO_SIDED|90.0|0.967|1.03||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||1.03|0.967|
71777310|NCT03270644|143054177|OTHER||Difference of LSMeans|-3.51|||||TWO_SIDED|90.0|-6.39|-0.64||||||PR interval was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||-0.64|-6.39|
71777311|NCT03270644|143054178|OTHER||Difference of LSMeans|5.57|||||TWO_SIDED|90.0|3.57|7.57||||||Systolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||7.57|3.57|
71777312|NCT03270644|143054179|OTHER||Difference of LSMeans|3.47|||||TWO_SIDED|90.0|1.99|4.95||||||Diastolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.||4.95|1.99|
71777313|NCT01914757|143054183|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.002|TWO_SIDED|95.0|0.49|0.85|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.85|0.49|0.002
71777314|NCT01914757|143054183|SUPERIORITY_OR_OTHER||Rate Ratio|0.72||||0.019|TWO_SIDED|95.0|0.54|0.95|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.95|0.54|0.019
71777315|NCT01914757|143054184|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.92|0.45|0.015
71777316|NCT01914757|143054184|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.005|TWO_SIDED|95.0|0.42|0.86|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.||||0.86|0.42|0.005
71777317|NCT01914757|143054185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125||||0.005|TWO_SIDED|95.0|0.037|0.213|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.213|0.037|0.005
71777318|NCT01914757|143054185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.01|TWO_SIDED|95.0|0.028|0.204|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.204|0.028|0.01
71777319|NCT01914757|143054186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.268|TWO_SIDED|95.0|-0.049|0.176|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.176|-0.049|0.268
71777320|NCT01914757|143054186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015||||0.786|TWO_SIDED|95.0|-0.127|0.096|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit||||0.096|-0.127|0.786
71777321|NCT01914757|143054187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.224|TWO_SIDED|95.0|-0.32|0.07|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.07|-0.32|0.224
71777322|NCT01914757|143054187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.019|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||-0.04|-0.43|0.019
71777323|NCT01914757|143054188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.287|TWO_SIDED|95.0|-0.44|0.13|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.13|-0.44|0.287
71890908|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.89||||0.5718|TWO_SIDED|95.0|-17.59|9.8|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||9.80|-17.59|0.5718
71777324|NCT01914757|143054188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.966|TWO_SIDED|95.0|-0.28|0.29|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.||||0.29|-0.28|0.966
71777325|NCT01914757|143054189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.603|TWO_SIDED|95.0|-0.58|0.99|||Mixed Models Analysis|Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.||||0.99|-0.58|0.603
71777326|NCT01914757|143054189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.209|TWO_SIDED|95.0|-1.29|0.28|||Mixed Models Analysis|Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.||||0.28|-1.29|0.209
71777327|NCT01914757|143054190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86||||0.029|TWO_SIDED|95.0|1.59|30.12|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||30.12|1.59|0.029
71777328|NCT01914757|143054190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.27||||0.037|TWO_SIDED|95.0|0.9|29.64|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56||29.64|0.9|0.037
71777329|NCT01914757|143054190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.54||||0.018|TWO_SIDED|95.0|3.07|32.0|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||32|3.07|0.018
71777330|NCT01914757|143054190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.22||||0.004|TWO_SIDED|95.0|6.65|35.79|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56||35.79|6.65|0.004
71777331|NCT01914757|143054191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.4|TWO_SIDED|95.0|-0.06|0.03|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.03|-0.06|0.4
71777332|NCT01914757|143054191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.146|TWO_SIDED|95.0|-0.08|0.01|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.||||0.01|-0.08|0.146
71777333|NCT01914757|143054192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.043|TWO_SIDED|95.0|-0.38|-0.01|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.01|-0.38|0.043
71777334|NCT01914757|143054192|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.008|TWO_SIDED|95.0|-0.44|-0.07|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||-0.07|-0.44|0.008
71777335|NCT01914757|143054193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.078|TWO_SIDED|95.0|-0.51|0.03|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.03|-0.51|0.078
71777336|NCT01914757|143054193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.||||0.16|-0.37|0.449
71777337|NCT01914757|143054194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.31|0.69|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.69|0.31|<0.001
71777338|NCT01914757|143054194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.023|TWO_SIDED|95.0|0.45|0.95|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with \>=1 asthma exacerbation||0.95|0.45|0.023
71743253|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.48|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.48
71743254|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.44|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.44
71743255|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.70
71743256|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71743257|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71743258|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71743259|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71743260|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743261|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.37|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.37
71743262|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
71890909|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.37||||0.6591|TWO_SIDED|95.0|-11.82|18.56|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||18.56|-11.82|0.6591
71743263|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.85|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.85
71743264|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71890910|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.02||||0.6921|TWO_SIDED|95.0|-18.17|12.13|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.13|-18.17|0.6921
71743265|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71743266|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71743267|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71743268|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71743269|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.31|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.31
71743270|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71743271|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.96|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.96
71743272|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71743273|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71743274|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.14|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.14
71743275|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743276|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.74|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.74
71743277|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71743278|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.01
71743279|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.72|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.72
71743280|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743281|NCT01128426|142997654|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71743282|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743283|NCT01128426|142997654|SUPERIORITY_OR_OTHER|||||||0.73|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.73
71743284|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743285|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71743286|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.27|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.27
71743287|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71777339|NCT01914757|143054195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.46|0.8|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first Exacerbation||0.80|0.46|<0.001
71777340|NCT01914757|143054195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.018|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first asthma exacerbation||0.95|0.55|0.018
71777341|NCT01914757|143054196|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.837|TWO_SIDED|95.0|0.48|1.82|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||1.82|0.48|0.837
71777342|NCT01914757|143054196|SUPERIORITY_OR_OTHER||Rate Ratio|1.23||||0.538|TWO_SIDED|95.0|0.64|2.35|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS||||2.35|0.64|0.538
71743288|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71743289|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.93
71743290|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71743291|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.52|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.52
71743292|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71743293|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71743294|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.05|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.05
71777343|NCT01914757|143054200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.119|TWO_SIDED|95.0|-0.04|0.37|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.37|-0.04|0.119
71777344|NCT01914757|143054200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.019|TWO_SIDED|95.0|0.04|0.45|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.||||0.45|0.04|0.019
71777345|NCT00333177|143054222|SUPERIORITY||||||<|0.03||||||P value is for CT-HBT X RLAI-Oral Ris interaction|ANCOVA|Covaried baseline value of dependent variable||A priori hypothesis was that CT would be superior to HBT and that RLAI would enhance this effect.||||<0.03
71777346|NCT00333177|143054223|SUPERIORITY||||||<|0.02||||||P-value is for each main effect. A priori threshold for statistical significance was p\<0.05 for each main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that LAI would be superior to oral risperidone and that CT would be superior to health behavior training (HBT) based on main effects.||||<.02
71777347|NCT00333177|143054224|SUPERIORITY||Mean Difference (Final Values)|0.84||||0.001|TWO_SIDED|95.0|0.57|1.1|||t-test, 2 sided|||A priori hypothesis was that RLAI would lead to less medication non-adherence than Oral Ris.||1.10|.57|.001
71777348|NCT00333177|143054225|SUPERIORITY||||||<|0.05||||||P-value is for CT vs. HBT main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.||||<.05
71743295|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.63|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.63
71743296|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.46|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.46
71743297|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.42|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.42
71743298|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.49|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.49
71743299|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71743300|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.28|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.28
71743301|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71743302|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.95
71743303|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.13
71743304|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.57|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.57
71743305|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.18|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.18
71743306|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.03
71743307|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.45
71743308|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71743309|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.66|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.66
71743310|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.67
71743311|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743312|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.69
71743313|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.53
71743314|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.16|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.16
71743315|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743316|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.08
71743317|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.98|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.98
71743318|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743319|NCT01128426|142997655|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71743320|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.22|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.22
71743321|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.02
71743322|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.17
71743323|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.87|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.87
71743324|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743325|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.54
71743326|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.23
71743327|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71743328|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.24|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.24
71777349|NCT00333177|143054226|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
71890911|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3513|TWO_SIDED|95.0|-19.98|7.2|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||7.20|-19.98|0.3513
71777350|NCT00333177|143054227|SUPERIORITY||||||<|0.02||||||A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|ANOVA|2 X 2 ANOVA was computed.||||||<0.02
71777351|NCT00333177|143054228|SUPERIORITY||||||<|0.01|||||||Chi-squared|df = 1||Chi-square of frequencies of relapse vs. non-relapse were calculated, with a priori hypothesis that RLAI would be superior to Oral Ris.||||<0.01
71777352|NCT00333177|143054229|SUPERIORITY||||||<|0.05||||||2 X 2 ANOVA calculated. P-value is for main effect of RLAI vs. Oral Ris.|ANOVA|||||||<.05
71777353|NCT00333177|143054230|SUPERIORITY||||||<|0.02||||||2 X 2 ANOVA computed. P-value is for main effect of CT vs. HBT.|ANOVA|||||||<.02
71777354|NCT00333177|143054231|SUPERIORITY||||||=|0.053||||||2 X 2 ANOVA computed. P-value is for RLAI vs. Oral Ris main effect.|ANOVA|||||||=.053
71777355|NCT02833350|143054233|SUPERIORITY||Weighted difference|8.0||||0.2503|TWO_SIDED|95.0|-5.64|21.64|||Cochran-Mantel-Haenszel|||||21.64|-5.64|0.2503
71777356|NCT02833350|143054233|SUPERIORITY||Weighted difference|12.93||||0.0164|TWO_SIDED|95.0|2.37|23.48|||Cochran-Mantel-Haenszel|||||23.48|2.37|0.0164
71777357|NCT02833350|143054233|SUPERIORITY||Weighted difference|20.0||||0.0003|TWO_SIDED|95.0|9.21|30.79|||Cochran-Mantel-Haenszel|||||30.79|9.21|0.0003
71777358|NCT02833350|143054235|SUPERIORITY||Weighted difference|-8.58||||0.1694|TWO_SIDED|95.0|-20.82|3.66|||Cochran-Mantel-Haenszel|||||3.66|-20.82|0.1694
71777359|NCT02833350|143054235|SUPERIORITY||Weighted difference|-1.5||||0.8132||95.0|-13.96|10.95|||Cochran-Mantel-Haenszel|||||10.95|-13.96|0.8132
71777360|NCT02833350|143054236|SUPERIORITY||Weighted difference|13.7||||0.0717|TWO_SIDED|95.0|-1.21|28.61|||Cochran-Mantel-Haenszel|||||28.61|-1.21|0.0717
71777361|NCT02833350|143054240|SUPERIORITY||adjusted difference|-0.11||||0.8504|TWO_SIDED|95.0|-0.45|0.23|||ANCOVA|||Week 1, Day 7||0.23|-0.45|0.8504
71777362|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.04||||0.9884|TWO_SIDED|95.0|-0.28|0.21|||ANCOVA|||At week 1, Day 7||0.21|-0.28|0.9884
71777363|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.06||||0.923|TWO_SIDED|95.0|-0.31|0.18|||ANCOVA|||Week 1 Day 7||0.18|-0.31|0.9230
71777364|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.06||||0.9853|TWO_SIDED|95.0|-0.43|0.31|||ANCOVA|||Week 2, Day 14||0.31|-0.43|0.9853
71777365|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.12||||0.6826|TWO_SIDED|95.0|-0.38|0.15|||ANCOVA|||Week 2, Day 14||0.15|-0.38|0.6826
71777366|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.18||||0.2634|TWO_SIDED|95.0|-0.45|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.45|0.2634
71777367|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.29||||0.2885|TWO_SIDED|95.0|-0.72|0.14|||ANCOVA|||Week 4, Day 28||0.14|-0.72|0.2885
71777368|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.3||||0.0598|TWO_SIDED|95.0|-0.61|0.01|||ANCOVA|||Week 4, Day 28||0.01|-0.61|0.0598
71777369|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.31||||0.044|TWO_SIDED|95.0|-0.62|-0.01|||ANCOVA|||Week 4, Day 28||-0.01|-0.62|0.0440
71777370|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.28||||0.4271|TWO_SIDED|95.0|-0.76|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.76|0.4271
71777371|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.31||||0.0969|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.66|0.0969
71777372|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.33||||0.0612|TWO_SIDED|95.0|-0.68|0.01|||ANCOVA|||Week 8, Day 56||0.01|-0.68|0.0612
71777373|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.36||||0.2079|TWO_SIDED|95.0|-0.84|0.12|||ANCOVA|||Week 12, Day 84||0.12|-0.84|0.2079
71777374|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
71777375|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.57||||0.0003|TWO_SIDED|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84||-0.22|-0.92|0.0003
71777376|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.34|0.82|||ANCOVA|||Week 1, Day 7||0.82|0.34|<.0001
71777377|NCT02833350|143054240|SUPERIORITY||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.31|0.8|||ANCOVA|||Week 1, Day 7||0.80|0.31|<0.0001
71777378|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Week 2, Day 14||0.74|0.20|<.0001
71777379|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.4||||0.0009|TWO_SIDED|95.0|0.13|0.66|||ANCOVA|||Week 2, Day 14||0.66|0.13|0.0009
71777380|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.56|||<|0.0001|TWO_SIDED|95.0|0.25|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.25|<.0001
71777381|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.55|||<|0.0001|TWO_SIDED|95.0|0.24|0.85|||ANCOVA|||Week 4, Day 28||0.85|0.24|<.0001
71777382|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.42||||0.0095|TWO_SIDED|95.0|0.08|0.76|||ANCOVA|||Week 8, Day 56||0.76|0.08|0.0095
71777383|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.4||||0.0153|TWO_SIDED|95.0|0.06|0.74|||ANCOVA|||Week 8, Day 56||0.74|0.06|0.0153
71777384|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.19||||0.4839|TWO_SIDED|95.0|-0.16|0.54|||ANCOVA|||Week 12, Day 84||0.54|-0.16|0.4839
71777385|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|0.19||||0.5035|TWO_SIDED|95.0|-0.16|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.16|0.5035
71777386|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.11||||0.4286|TWO_SIDED|95.0|-0.38|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.38|0.4286
71777387|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.2||||0.1831|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||Week 2, Day 14||0.10|-0.50|0.1831
71777388|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.31||||0.0667|TWO_SIDED|95.0|-0.65|0.02|||ANCOVA|||Week 4, Day 28||0.02|-0.65|0.0667
71743329|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743330|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.21
71743331|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.29|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.29
71743332|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.06|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.06
71743333|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.61|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.61
71743334|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.07
71743335|NCT01128426|142997655|SUPERIORITY_OR_OTHER||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||<0.01
71743336|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.04|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.04
71743337|NCT01128426|142997655|SUPERIORITY_OR_OTHER|||||||0.68|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.||||0.68
71743338|NCT00550953|142997656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|6.41|9.63|||ANCOVA||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy|||9.63|6.41|<0.0001
71890912|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.2346|TWO_SIDED|95.0|-5.96|23.88|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||23.88|-5.96|0.2346
71743339|NCT02905266|142997664|SUPERIORITY||Percent Difference in incidence rates|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Fixed Ratio Combination over Sequential Combination|||0.0|0.0|
71743340|NCT02905266|142997672|SUPERIORITY||Percent Difference of ORRs|-7.5|||||TWO_SIDED|95.0|-26.1|11.0|||||Cochran-Mantel-Haenszel (CMH) method of weighting|||11.0|-26.1|
71777389|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.42|||ANCOVA|||Week 8, Day 56||-0.42|-1.11|<0.0001
71743341|NCT02905266|142997672|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.35|1.58||||||||1.58|0.35|
71743342|NCT02905266|142997673|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.78|2.37|||||Stratified Cox proportional hazard model|||2.37|0.78|
71743343|NCT02905266|142997674|SUPERIORITY||Cochran-Mantel-Haenszel Odds Ratio|0.87|||||TWO_SIDED|95.0|0.3|2.49|||||Fixed Ratio Combination over Sequential Combination|||2.49|0.30|
71743344|NCT02905266|142997674|SUPERIORITY||Percent difference in incidence rates|-1.9|||||TWO_SIDED|95.0|-16.0|12.2|||||Fixed Ratio Combination over Sequential Combination|||12.2|-16.0|
71743345|NCT03201419|142997700|SUPERIORITY||Mean Difference|-0.3|||||TWO_SIDED|95.0|-0.54|-0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.07|-0.54|
71743346|NCT03201419|142997700|SUPERIORITY||Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.46|-0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.02|-0.46|
71743347|NCT03201419|142997700|SUPERIORITY||Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.36|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.36|
71743348|NCT03201419|142997700|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.23|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.23|
71743349|NCT03201419|142997700|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.14|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.14|
71743350|NCT03201419|142997700|SUPERIORITY||Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||-0.00|-0.07|
71743351|NCT03201419|142997701|SUPERIORITY||Mean Difference|-0.139||||0.4214|TWO_SIDED|95.0|-0.48|0.201||Threshold for significance at 0.05 level.|MMRM|||||0.201|-0.480|0.4214
71743352|NCT03201419|142997701|SUPERIORITY||Mean Difference|-0.587||||0.0101|TWO_SIDED|95.0|-1.034|-0.141||Threshold for significance at 0.05 level.|MMRM|||||-0.141|-1.034|0.0101
71743353|NCT03201419|142997701|SUPERIORITY||Mean Difference|-0.148||||0.5203|TWO_SIDED|95.0|-0.599|0.304||Threshold for significance at 0.05 level.|MMRM|||||0.304|-0.599|0.5203
71743354|NCT03201419|142997701|SUPERIORITY||Mean Difference|0.055||||0.8483|TWO_SIDED|95.0|-0.508|0.617||Threshold for significance at 0.05 level.|MMRM|||||0.617|-0.508|0.8483
71743355|NCT03201419|142997701|SUPERIORITY||Mean Difference|-0.147||||0.6357|TWO_SIDED|95.0|-0.759|0.464||Threshold for significance at 0.05 level.|MMRM|||||0.464|-0.759|0.6357
71743356|NCT03201419|142997701|SUPERIORITY||Mean Difference|0.25||||0.2222|TWO_SIDED|95.0|-0.152|0.652||Threshold for significance at 0.05 level.|MMRM|||||0.652|-0.152|0.2222
71743357|NCT03201419|142997702|SUPERIORITY||Mean Difference|-0.166||||0.2909|TWO_SIDED|95.0|-0.474|0.143||Threshold for significance at 0.05 level.|MMRM|||||0.143|-0.474|0.2909
71743358|NCT03201419|142997702|SUPERIORITY||Mean Difference|-0.418||||0.044|TWO_SIDED|95.0|-0.824|-0.011||Threshold for significance at 0.05 level.|MMRM|||||-0.011|-0.824|0.0440
71743359|NCT03201419|142997702|SUPERIORITY||Mean Difference|0.128||||0.5438|TWO_SIDED|95.0|-0.288|0.545||Threshold for significance at 0.05 level.|MMRM|||||0.545|-0.288|0.5438
71743360|NCT03201419|142997702|SUPERIORITY||Mean Difference|0.441||||0.096|TWO_SIDED|95.0|-0.079|0.962||Threshold for significance at 0.05 level.|MMRM|||||0.962|-0.079|0.0960
71743361|NCT03201419|142997702|SUPERIORITY||Mean Difference|-0.04||||0.8826|TWO_SIDED|95.0|-0.568|0.488||Threshold for significance at 0.05 level.|MMRM|||||0.488|-0.568|0.8826
71777390|NCT02833350|143054240|SUPERIORITY||Adjusted Difference|-0.76||||0.0002|TWO_SIDED|95.0|-1.15|-0.38|||ANCOVA|||Week 12, Day 84||-0.38|-1.15|0.0002
71664492|NCT03301649|142842044|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|1.9|||||TWO_SIDED|90.0|-3.9|7.8||||||If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||7.8|-3.9|
71664493|NCT03301649|142842045|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward \[LOCF\] method).||||<0.0001
71664494|NCT03301649|142842045|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
71743362|NCT03201419|142997702|SUPERIORITY||Mean Difference|0.394||||0.0344|TWO_SIDED|95.0|0.029|0.759||Threshold for significance at 0.05 level.|MMRM|||||0.759|0.029|0.0344
71743363|NCT03201419|142997703|SUPERIORITY||Mean Difference|-0.132||||0.4732|TWO_SIDED|95.0|-0.496|0.231||Threshold for significance at 0.05 level.|MMRM|||||0.231|-0.496|0.4732
71743364|NCT03201419|142997703|SUPERIORITY||Mean Difference|-0.224||||0.3394|TWO_SIDED|95.0|-0.685|0.237||Threshold for significance at 0.05 level.|MMRM|||||0.237|-0.685|0.3394
71743365|NCT03201419|142997703|SUPERIORITY||Mean Difference|-0.012||||0.96|TWO_SIDED|95.0|-0.488|0.463||Threshold for significance at 0.05 level.|MMRM|||||0.463|-0.488|0.9600
71743366|NCT03201419|142997703|SUPERIORITY||Mean Difference|0.463||||0.1131|TWO_SIDED|95.0|-0.111|1.037||Threshold for significance at 0.05 level.|MMRM|||||1.037|-0.111|0.1131
71743367|NCT03201419|142997703|SUPERIORITY||Mean Difference|-0.124||||0.6853|TWO_SIDED|95.0|-0.729|0.48||Threshold for significance at 0.05 level.|MMRM|||||0.480|-0.729|0.6853
71664495|NCT03301649|142842046|EQUIVALENCE|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|0.9|||||TWO_SIDED|90.0|-2.6|4.5||||||If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.||4.5|-2.6|
71664496|NCT03301649|142842047|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
71743368|NCT03201419|142997703|SUPERIORITY||Mean Difference|0.166||||0.4364|TWO_SIDED|95.0|-0.254|0.587||Threshold for significance at 0.05 level.|MMRM|||||0.587|-0.254|0.4364
71743369|NCT03201419|142997704|SUPERIORITY||Mean Difference|-0.299||||0.1106|TWO_SIDED|95.0|-0.667|0.069||Threshold for significance at 0.05 level.|MMRM|||||0.069|-0.667|0.1106
71743370|NCT03201419|142997704|SUPERIORITY||Mean Difference|-0.163||||0.5005|TWO_SIDED|95.0|-0.639|0.313||Threshold for significance at 0.05 level.|MMRM|||||0.313|-0.639|0.5005
71743371|NCT03201419|142997704|SUPERIORITY||Mean Difference|0.107||||0.6604|TWO_SIDED|95.0|-0.372|0.586||Threshold for significance at 0.05 level.|MMRM|||||0.586|-0.372|0.6604
71743372|NCT03201419|142997704|SUPERIORITY||Mean Difference|0.283||||0.3178|TWO_SIDED|95.0|-0.275|0.842||Threshold for significance at 0.05 level.|MMRM|||||0.842|-0.275|0.3178
71743373|NCT03201419|142997704|SUPERIORITY||Mean Difference|-0.096||||0.7561|TWO_SIDED|95.0|-0.701|0.51||Threshold for significance at 0.05 level.|MMRM|||||0.510|-0.701|0.7561
71664497|NCT03301649|142842047|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).||||<0.0001
71664498|NCT01564537|142842048|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.742||||0.012|TWO_SIDED|95.0|0.587|0.939|||Log Rank||HR is estimated from Cox Regression.|||0.939|0.587|0.012
71664499|NCT01564537|142842049|SUPERIORITY||Hazard Ratio (HR)|0.939|||=|0.495|TWO_SIDED|95.0|0.784|1.125|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.125|0.784|=0.495
71664500|NCT01564537|142842050|SUPERIORITY||Hazard Ratio (HR)|0.916|||=|0.764|TWO_SIDED|95.0|0.516|1.626|||Log Rank||HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.|||1.626|0.516|=0.764
71743374|NCT03201419|142997704|SUPERIORITY||Mean Difference|0.037||||0.8614|TWO_SIDED|95.0|-0.378|0.452||Threshold for significance at 0.05 level.|MMRM|||||0.452|-0.378|0.8614
71743375|NCT03201419|142997705|SUPERIORITY||Odds Ratio (OR)|1.759||||0.117|TWO_SIDED|95.0|0.869|3.56||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.560|0.869|0.117
71743376|NCT03201419|142997705|SUPERIORITY||Odds Ratio (OR)|2.505||||0.048|TWO_SIDED|95.0|1.01|6.214||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.214|1.010|0.048
71743377|NCT03201419|142997705|SUPERIORITY||Odds Ratio (OR)|1.42||||0.46|TWO_SIDED|95.0|0.56|3.602||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.602|0.560|0.460
71743378|NCT03201419|142997705|SUPERIORITY||Odds Ratio (OR)|1.704||||0.367|TWO_SIDED|95.0|0.535|5.427||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.427|0.535|0.367
71743379|NCT03201419|142997705|SUPERIORITY||Odds Ratio (OR)|1.689||||0.407|TWO_SIDED|95.0|0.489|5.825||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.825|0.489|0.407
71743380|NCT03201419|142997705|SUPERIORITY||Odds Ratio (OR)|1.069||||0.876|TWO_SIDED|95.0|0.462|2.473||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.473|0.462|0.876
71743381|NCT03201419|142997706|SUPERIORITY||Odds Ratio (OR)|0.971||||0.937|TWO_SIDED|95.0|0.47|2.005||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.005|0.470|0.937
71743382|NCT03201419|142997706|SUPERIORITY||Odds Ratio (OR)|4.738||||0.028|TWO_SIDED|95.0|1.183|18.968||Threshold for significance at 0.05 level.|Regression, Logistic|||||18.968|1.183|0.028
71743383|NCT03201419|142997706|SUPERIORITY||Odds Ratio (OR)|0.513||||0.166|TWO_SIDED|95.0|0.2|1.318||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.318|0.200|0.166
71743384|NCT03201419|142997706|SUPERIORITY||Odds Ratio (OR)|0.433||||0.174|TWO_SIDED|95.0|0.129|1.447||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.447|0.129|0.174
71743385|NCT03201419|142997706|SUPERIORITY||Odds Ratio (OR)|1.425||||0.608|TWO_SIDED|95.0|0.369|5.512||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.512|0.369|0.608
71743386|NCT03201419|142997706|SUPERIORITY||Odds Ratio (OR)|0.553||||0.171|TWO_SIDED|95.0|0.237|1.292||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.292|0.237|0.171
71743387|NCT03201419|142997707|SUPERIORITY||Odds Ratio (OR)|0.928||||0.85|TWO_SIDED|95.0|0.43|2.003||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.003|0.430|0.850
71743388|NCT03201419|142997707|SUPERIORITY||Odds Ratio (OR)|2.261||||0.15|TWO_SIDED|95.0|0.745|6.862||Threshold for significance at 0.05 level.|Regression, Logistic|||||6.862|0.745|0.150
71743389|NCT03201419|142997707|SUPERIORITY||Odds Ratio (OR)|1.283||||0.632|TWO_SIDED|95.0|0.462|3.566||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.566|0.462|0.632
71743390|NCT03201419|142997707|SUPERIORITY||Odds Ratio (OR)|0.583||||0.363|TWO_SIDED|95.0|0.183|1.863||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.863|0.183|0.363
71743391|NCT03201419|142997707|SUPERIORITY||Odds Ratio (OR)|0.691||||0.555|TWO_SIDED|95.0|0.203|2.359||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.359|0.203|0.555
71743392|NCT03201419|142997707|SUPERIORITY||Odds Ratio (OR)|0.991||||0.984|TWO_SIDED|95.0|0.408|2.405||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.405|0.408|0.984
71777391|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.18||||0.5807|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.55|0.5807
71743393|NCT03201419|142997708|SUPERIORITY||Odds Ratio (OR)|2.462||||0.046|TWO_SIDED|95.0|1.017|5.961||Threshold for significance at 0.05 level.|Regression, Logistic|||||5.961|1.017|0.046
71890913|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.24||||0.4138|TWO_SIDED|95.0|-8.92|21.39|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.39|-8.92|0.4138
71743394|NCT03201419|142997708|SUPERIORITY||Odds Ratio (OR)|1.19||||0.745|TWO_SIDED|95.0|0.418|3.386||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.386|0.418|0.745
71743395|NCT03201419|142997708|SUPERIORITY||Odds Ratio (OR)|1.147||||0.79|TWO_SIDED|95.0|0.417|3.155||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.155|0.417|0.790
71743396|NCT03201419|142997708|SUPERIORITY||Odds Ratio (OR)|0.537||||0.293|TWO_SIDED|95.0|0.169|1.71||Threshold for significance at 0.05 level.|Regression, Logistic|||||1.710|0.169|0.293
71743397|NCT03201419|142997708|SUPERIORITY||Odds Ratio (OR)|0.881||||0.843|TWO_SIDED|95.0|0.252|3.076||Threshold for significance at 0.05 level.|Regression, Logistic|||||3.076|0.252|0.843
71743398|NCT03201419|142997708|SUPERIORITY||Odds Ratio (OR)|0.877||||0.763|TWO_SIDED|95.0|0.375|2.053||Threshold for significance at 0.05 level.|Regression, Logistic|||||2.053|0.375|0.763
71743399|NCT03201419|142997709|SUPERIORITY||Odds Ratio (OR)|1.422|||||TWO_SIDED|95.0|0.868|2.597||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.597|0.868|
71743400|NCT03201419|142997709|SUPERIORITY||Odds Ratio (OR)|1.373|||||TWO_SIDED|95.0|0.905|2.45||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.450|0.905|
71743401|NCT03201419|142997709|SUPERIORITY||Odds Ratio (OR)|1.284|||||TWO_SIDED|95.0|0.927|2.264||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.264|0.927|
71743402|NCT03201419|142997709|SUPERIORITY||Odds Ratio (OR)|1.145|||||TWO_SIDED|95.0|0.957|1.896||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.896|0.957|
71743403|NCT03201419|142997709|SUPERIORITY||Odds Ratio (OR)|1.079|||||TWO_SIDED|95.0|0.972|1.638||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.638|0.972|
71743404|NCT03201419|142997709|SUPERIORITY||Odds Ratio (OR)|1.023|||||TWO_SIDED|95.0|0.991|1.313||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.313|0.991|
71743405|NCT03201419|142997710|SUPERIORITY||Mean Difference|0.52||||0.8463|TWO_SIDED|95.0|-4.75|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-4.75|0.8463
71743406|NCT03201419|142997710|SUPERIORITY||Mean Difference|-13.85||||0.0001|TWO_SIDED|95.0|-20.89|-6.81||Threshold for significance at 0.05 level.|MMRM|||||-6.81|-20.89|0.0001
71743407|NCT03201419|142997710|SUPERIORITY||Mean Difference|-2.84||||0.4355|TWO_SIDED|95.0|-9.99|4.32||Threshold for significance at 0.05 level.|MMRM|||||4.32|-9.99|0.4355
71743408|NCT03201419|142997710|SUPERIORITY||Mean Difference|-0.87||||0.8483|TWO_SIDED|95.0|-9.79|8.06||Threshold for significance at 0.05 level.|MMRM|||||8.06|-9.79|0.8483
71743409|NCT03201419|142997710|SUPERIORITY||Mean Difference|-1.61||||0.7336|TWO_SIDED|95.0|-10.91|7.69||Threshold for significance at 0.05 level.|MMRM|||||7.69|-10.91|0.7336
71743410|NCT03201419|142997710|SUPERIORITY||Mean Difference|-0.69||||0.8347|TWO_SIDED|95.0|-7.15|5.78||Threshold for significance at 0.05 level.|MMRM|||||5.78|-7.15|0.8347
71743411|NCT03201419|142997711|SUPERIORITY||Mean Difference|1.59||||0.5695|TWO_SIDED|95.0|-3.9|7.07||Threshold for significance at 0.05 level.|MMRM|||||7.07|-3.90|0.5695
71743412|NCT03201419|142997711|SUPERIORITY||Mean Difference|-3.23||||0.3784|TWO_SIDED|95.0|-10.46|3.99||Threshold for significance at 0.05 level.|MMRM|||||3.99|-10.46|0.3784
71743413|NCT03201419|142997711|SUPERIORITY||Mean Difference|-0.17||||0.9653|TWO_SIDED|95.0|-7.67|7.34||Threshold for significance at 0.05 level.|MMRM|||||7.34|-7.67|0.9653
71743414|NCT03201419|142997711|SUPERIORITY||Mean Difference|2.97||||0.5304|TWO_SIDED|95.0|-6.35|12.29||Threshold for significance at 0.05 level.|MMRM|||||12.29|-6.35|0.5304
71777392|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.12||||0.627|TWO_SIDED|95.0|-0.39|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.39|0.6270
71777393|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.15||||0.4475|TWO_SIDED|95.0|-0.42|0.12|||ANCOVA|||Week 1, Day 7||0.12|-0.42|0.4475
71777394|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.06||||0.9891|TWO_SIDED|95.0|-0.47|0.35|||ANCOVA|||Week 2, Day 14||0.35|-0.47|0.9891
71890914|NCT01587950|143303692|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.72||||0.6931|TWO_SIDED|95.0|-16.44|10.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.99|-16.44|0.6931
71743415|NCT03201419|142997711|SUPERIORITY||Mean Difference|-8.02||||0.0968|TWO_SIDED|95.0|-17.51|1.46||Threshold for significance at 0.05 level.|MMRM|||||1.46|-17.51|0.0968
71743416|NCT03201419|142997711|SUPERIORITY||Mean Difference|0.91||||0.7885|TWO_SIDED|95.0|-5.79|7.62||Threshold for significance at 0.05 level.|MMRM|||||7.62|-5.79|0.7885
71743417|NCT03201419|142997712|SUPERIORITY||Mean Difference|-1.2||||0.6792|TWO_SIDED|95.0|-6.89|4.5||Threshold for significance at 0.05 level.|MMRM|||||4.50|-6.89|0.6792
71743418|NCT03201419|142997712|SUPERIORITY||Mean Difference|-8.39||||0.0276|TWO_SIDED|95.0|-15.84|-0.93||Threshold for significance at 0.05 level.|MMRM|||||-0.93|-15.84|0.0276
71743419|NCT03201419|142997712|SUPERIORITY||Mean Difference|-0.27||||0.9445|TWO_SIDED|95.0|-7.97|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-7.97|0.9445
71743420|NCT03201419|142997712|SUPERIORITY||Mean Difference|2.79||||0.5637|TWO_SIDED|95.0|-6.71|12.28||Threshold for significance at 0.05 level.|MMRM|||||12.28|-6.71|0.5637
71743421|NCT03201419|142997712|SUPERIORITY||Mean Difference|-4.4||||0.387|TWO_SIDED|95.0|-14.39|5.6||Threshold for significance at 0.05 level.|MMRM|||||5.60|-14.39|0.3870
71743422|NCT03201419|142997712|SUPERIORITY||Mean Difference|0.72||||0.8373|TWO_SIDED|95.0|-6.19|7.63||Threshold for significance at 0.05 level.|MMRM|||||7.63|-6.19|0.8373
71743423|NCT03201419|142997713|SUPERIORITY||Mean Difference|0.53||||0.8646|TWO_SIDED|95.0|-5.54|6.59||Threshold for significance at 0.05 level.|MMRM|||||6.59|-5.54|0.8646
71743424|NCT03201419|142997713|SUPERIORITY||Mean Difference|-6.99||||0.087|TWO_SIDED|95.0|-15.0|1.02||Threshold for significance at 0.05 level.|MMRM|||||1.02|-15.00|0.0870
71743425|NCT03201419|142997713|SUPERIORITY||Mean Difference|2.77||||0.51|TWO_SIDED|95.0|-5.5|11.04||Threshold for significance at 0.05 level.|MMRM|||||11.04|-5.50|0.5100
71743426|NCT03201419|142997713|SUPERIORITY||Mean Difference|7.32||||0.1535|TWO_SIDED|95.0|-2.75|17.39||Threshold for significance at 0.05 level.|MMRM|||||17.39|-2.75|0.1535
71777395|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.21||||0.2244|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Week 2, Day 14||0.08|-0.51|0.2244
71743427|NCT03201419|142997713|SUPERIORITY||Mean Difference|-5.14||||0.3369|TWO_SIDED|95.0|-15.66|5.38||Threshold for significance at 0.05 level.|MMRM|||||5.38|-15.66|0.3369
71743428|NCT03201419|142997713|SUPERIORITY||Mean Difference|0.27||||0.9417|TWO_SIDED|95.0|-7.05|7.59||Threshold for significance at 0.05 level.|MMRM|||||7.59|-7.05|0.9417
71743429|NCT03201419|142997714|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-1.41|5.47||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||5.47|-1.41|
71743430|NCT03201419|142997714|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.43|1.19||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||1.19|-0.43|
71743431|NCT03201419|142997714|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.16|0.5||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.50|-0.16|
71743432|NCT03201419|142997714|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.03|0.15||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.15|-0.03|
71743433|NCT03201419|142997714|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|-0.01|0.05||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.05|-0.01|
71743434|NCT03201419|142997714|SUPERIORITY||Median difference|0.0|||||TWO_SIDED|95.0|0.0|0.01||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.01|-0.00|
71743435|NCT03201419|142997715|SUPERIORITY||Mean Difference|5.2||||0.3328|TWO_SIDED|95.0|-5.3|15.7||Threshold for significance at 0.05 level.|ANCOVA|||||15.7|-5.3|0.3328
71743436|NCT03201419|142997715|SUPERIORITY||Mean Difference|15.5||||0.0255|TWO_SIDED|95.0|1.9|29.2||Threshold for significance at 0.05 level.|ANCOVA|||||29.2|1.9|0.0255
71743437|NCT03201419|142997715|SUPERIORITY||Mean Difference|2.5||||0.7296|TWO_SIDED|95.0|-11.7|16.7||Threshold for significance at 0.05 level.|ANCOVA|||||16.7|-11.7|0.7296
71743438|NCT03201419|142997715|SUPERIORITY||Mean Difference|-6.7||||0.4586|TWO_SIDED|95.0|-24.5|11.1||Threshold for significance at 0.05 level.|ANCOVA|||||11.1|-24.5|0.4586
71743439|NCT03201419|142997715|SUPERIORITY||Mean Difference|11.2||||0.2327|TWO_SIDED|95.0|-7.2|29.5||Threshold for significance at 0.05 level.|ANCOVA|||||29.5|-7.2|0.2327
71743440|NCT03201419|142997715|SUPERIORITY||Mean Difference|-0.6||||0.924|TWO_SIDED|95.0|-13.3|12.1||Threshold for significance at 0.05 level.|ANCOVA|||||12.1|-13.3|0.9240
71743441|NCT03201419|142997716|SUPERIORITY||Mean Difference|0.3||||0.9499|TWO_SIDED|95.0|-7.9|8.5||Threshold for significance at 0.05 level.|ANCOVA|||||8.5|-7.9|0.9499
71743442|NCT03201419|142997716|SUPERIORITY||Mean Difference|5.8||||0.2842|TWO_SIDED|95.0|-4.8|16.4||Threshold for significance at 0.05 level.|ANCOVA|||||16.4|-4.8|0.2842
71743443|NCT03201419|142997716|SUPERIORITY||Mean Difference|-5.7||||0.31|TWO_SIDED|95.0|-16.8|5.4||Threshold for significance at 0.05 level.|ANCOVA|||||5.4|-16.8|0.3100
71743444|NCT03201419|142997716|SUPERIORITY||Mean Difference|-10.1||||0.1499|TWO_SIDED|95.0|-23.9|3.7||Threshold for significance at 0.05 level.|ANCOVA|||||3.7|-23.9|0.1499
71743445|NCT03201419|142997716|SUPERIORITY||Mean Difference|-8.2||||0.2571|TWO_SIDED|95.0|-22.5|6.0||Threshold for significance at 0.05 level.|ANCOVA|||||6.0|-22.5|0.2571
71743446|NCT03201419|142997716|SUPERIORITY||Mean Difference|-1.5||||0.7629|TWO_SIDED|95.0|-11.4|8.3||Threshold for significance at 0.05 level.|ANCOVA|||||8.3|-11.4|0.7629
71743447|NCT03201419|142997717|SUPERIORITY||Mean Difference|2.48||||0.4846|TWO_SIDED|95.0|-4.5|9.46||Threshold for significance at 0.05 level.|MMRM|||||9.46|-4.50|0.4846
71743448|NCT03201419|142997717|SUPERIORITY||Mean Difference|-16.93||||0.0004|TWO_SIDED|95.0|-26.26|-7.6||Threshold for significance at 0.05 level.|MMRM|||||-7.60|-26.26|0.0004
71743449|NCT03201419|142997717|SUPERIORITY||Mean Difference|-2.05||||0.6685|TWO_SIDED|95.0|-11.47|7.37||Threshold for significance at 0.05 level.|MMRM|||||7.37|-11.47|0.6685
71743450|NCT03201419|142997717|SUPERIORITY||Mean Difference|1.69||||0.7772|TWO_SIDED|95.0|-10.07|13.46||Threshold for significance at 0.05 level.|MMRM|||||13.46|-10.07|0.7772
71777396|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.28||||0.0586|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA|||Week 2, Day 14||0.01|-0.58|0.0586
71743451|NCT03201419|142997717|SUPERIORITY||Mean Difference|10.67||||0.0895|TWO_SIDED|95.0|-1.66|23.0||Threshold for significance at 0.05 level.|MMRM|||||23.00|-1.66|0.0895
71743452|NCT03201419|142997717|SUPERIORITY||Mean Difference|1.2||||0.782|TWO_SIDED|95.0|-7.34|9.74|||MMRM|||||9.74|-7.34|0.7820
71777397|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.39||||0.1338|TWO_SIDED|95.0|-0.85|0.08|||ANCOVA|||Week 4, Day 28||0.08|-0.85|0.1338
71777398|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.4||||0.0119|TWO_SIDED|95.0|-0.74|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.74|0.0119
71777399|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.44||||0.0046|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Week 4, Day 28||-0.11|-0.77|0.0046
71777400|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.31||||0.3943|TWO_SIDED|95.0|-0.82|0.2|||ANCOVA|||Week 8, Day 56||0.20|-0.82|0.3943
71777401|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.37||||0.0526|TWO_SIDED|95.0|-0.74|0.0|||ANCOVA|||Week 8, Day 56||0.00|-0.74|0.0526
71777402|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.39||||0.0365|TWO_SIDED|95.0|-0.76|-0.02|||ANCOVA|||Week 8, Day 56||-0.02|-0.76|0.0365
71777403|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.41||||0.1696|TWO_SIDED|95.0|-0.93|0.11|||ANCOVA|||Week 12, Day 84||0.11|-0.93|0.1696
71777404|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.63||||0.0002|TWO_SIDED|95.0|-1.01|-0.25|||ANCOVA|||Week 12, Day 84||-0.25|-1.01|0.0002
71777405|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.62||||0.0003|TWO_SIDED|95.0|-1.0|-0.24|||ANCOVA|||Week 12, Day 84||-0.24|-1.00|0.0003
71777406|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.37|0.9|||ANCOVA|||Week 1, Day 7||0.90|0.37|<0.0001
71890915|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.39||||0.3867|TWO_SIDED|95.0|-21.04|8.26|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.26|-21.04|0.3867
71743453|NCT03201419|142997718|SUPERIORITY||Mean Difference|-0.41||||0.9175|TWO_SIDED|95.0|-8.25|7.42||Threshold for significance at 0.05 level.|MMRM|||||7.42|-8.25|0.9175
71743454|NCT03201419|142997718|SUPERIORITY||Mean Difference|-4.32||||0.4098|TWO_SIDED|95.0|-14.62|5.98||Threshold for significance at 0.05 level.|MMRM|||||5.98|-14.62|0.4098
71743455|NCT03201419|142997718|SUPERIORITY||Mean Difference|2.41||||0.6566|TWO_SIDED|95.0|-8.25|13.06||Threshold for significance at 0.05 level.|MMRM|||||13.06|-8.25|0.6566
71777407|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.34|0.88|||ANCOVA|||Week 1, Day 7||0.88|0.34|<0.0001
71777408|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.5||||0.0001|TWO_SIDED|95.0|0.21|0.79|||ANCOVA|||Week 2, Day 14||0.79|0.21|0.0001
71777409|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.43||||0.0012|TWO_SIDED|95.0|0.14|0.72|||ANCOVA|||Week 2, Day 14||0.72|0.14|0.0012
71777410|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.25|0.91|||ANCOVA|||Week 4, Day 28||0.91|0.25|<0.0001
71777411|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.54||||0.0002|TWO_SIDED|95.0|0.21|0.87|||ANCOVA|||Week 4, Day 28||0.87|0.21|0.0002
71777412|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.46||||0.0084|TWO_SIDED|95.0|0.09|0.82|||ANCOVA|||Week 8, Day 56||0.82|0.09|0.0084
71777413|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.44||||0.0124|TWO_SIDED|95.0|0.07|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.07|0.0124
71777414|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.15||||0.7565|TWO_SIDED|95.0|-0.23|0.52|||ANCOVA|||Week 12, Day 84||0.52|-0.23|0.7565
71777415|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|0.16||||0.7158|TWO_SIDED|95.0|-0.22|0.53|||ANCOVA|||Week 12, Day 84||0.53|-0.22|0.7158
71777416|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.22||||0.1368|TWO_SIDED|95.0|-0.52|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.52|0.1368
71777417|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.28||||0.0974|TWO_SIDED|95.0|-0.62|0.05|||ANCOVA|||Week 2, Day 14||0.05|-0.62|0.0974
71777418|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.38||||0.0479|TWO_SIDED|95.0|-0.76|0.0|||ANCOVA|||Week 4, Day 28||-0.00|-0.76|0.0479
71777419|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.46|||ANCOVA|||Week 8, Day 56||-0.46|-1.22|<0.0001
71777420|NCT02833350|143054241|SUPERIORITY||Adjusted Difference|-0.83||||0.0001|TWO_SIDED|95.0|-1.24|-0.42|||ANCOVA|||Week 12, Day 84||-0.42|-1.24|0.0001
71777421|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.09||||0.9193|TWO_SIDED|95.0|-0.41|0.24|||ANCOVA|||Week 1, Day 7||0.24|-0.41|0.9193
71777422|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.1||||0.7062|TWO_SIDED|95.0|-0.33|0.14|||ANCOVA|||Week 1, Day 7||0.14|-0.33|0.7062
71777423|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.08||||0.8542|TWO_SIDED|95.0|-0.31|0.16|||ANCOVA|||Week 1, Day 7||0.16|-0.31|0.8542
71777424|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.13||||0.8095|TWO_SIDED|95.0|-0.51|0.24|||ANCOVA|||Week 2, Day 14||0.24|-0.51|0.8095
71777425|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.17||||0.3862|TWO_SIDED|95.0|-0.44|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.44|0.3862
71777426|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.16||||0.4328|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|||Week 2, Day 14||0.12|-0.43|0.4328
71777427|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.24||||0.4915|TWO_SIDED|95.0|-0.68|0.2|||ANCOVA|||Week 4, Day 28||0.20|-0.68|0.4915
71777428|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.26||||0.1441|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Week 4, Day 28||0.06|-0.58|0.1441
71777429|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.24||||0.189|TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Week 4, Day 28||0.07|-0.56|0.1890
71777430|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.25||||0.5566|TWO_SIDED|95.0|-0.74|-0.24|||ANCOVA|||Week 8, Day 56||-0.24|-0.74|0.5566
71777431|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.32||||0.092|TWO_SIDED|95.0|-0.68|0.04|||ANCOVA|||Week 8, Day 56||0.04|-0.68|0.0920
71890916|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.22||||0.1448|TWO_SIDED|95.0|-26.41|3.96|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||3.96|-26.41|0.1448
71743456|NCT03201419|142997718|SUPERIORITY||Mean Difference|3.39||||0.6144|TWO_SIDED|95.0|-9.85|16.63||Threshold for significance at 0.05 level.|MMRM|||||16.63|-9.85|0.6144
71743457|NCT03201419|142997718|SUPERIORITY||Mean Difference|3.8||||0.5798|TWO_SIDED|95.0|-9.71|17.31||Threshold for significance at 0.05 level.|MMRM|||||17.31|-9.71|0.5798
71743458|NCT03201419|142997718|SUPERIORITY||Mean Difference|0.35||||0.9417|TWO_SIDED|95.0|-9.17|9.88||Threshold for significance at 0.05 level.|MMRM|||||9.88|-9.17|0.9417
71743459|NCT03201419|142997719|SUPERIORITY||Mean Difference|-2.81||||0.5148|TWO_SIDED|95.0|-11.31|5.68||Threshold for significance at 0.05 level.|MMRM|||||5.68|-11.31|0.5148
71743460|NCT03201419|142997719|SUPERIORITY||Mean Difference|-9.65||||0.0879|TWO_SIDED|95.0|-20.75|1.44||Threshold for significance at 0.05 level.|MMRM|||||1.44|-20.75|0.0879
71743461|NCT03201419|142997719|SUPERIORITY||Mean Difference|3.61||||0.5335|TWO_SIDED|95.0|-7.79|15.0||Threshold for significance at 0.05 level.|MMRM|||||15.00|-7.79|0.5335
71743462|NCT03201419|142997719|SUPERIORITY||Mean Difference|6.29||||0.3787|TWO_SIDED|95.0|-7.76|20.34||Threshold for significance at 0.05 level.|MMRM|||||20.34|-7.76|0.3787
71743463|NCT03201419|142997719|SUPERIORITY||Mean Difference|1.48||||0.8448|TWO_SIDED|95.0|-13.41|16.38||Threshold for significance at 0.05 level.|MMRM|||||16.38|-13.41|0.8448
71743464|NCT03201419|142997719|SUPERIORITY||Mean Difference|4.62||||0.3751|TWO_SIDED|95.0|-5.63|14.87||Threshold for significance at 0.05 level.|MMRM|||||14.87|-5.63|0.3751
71743465|NCT03201419|142997720|SUPERIORITY||Mean Difference|-0.43||||0.9245|TWO_SIDED|95.0|-9.43|8.57||Threshold for significance at 0.05 level.|MMRM|||||8.57|-9.43|0.9245
71743466|NCT03201419|142997720|SUPERIORITY||Mean Difference|-6.72||||0.2657|TWO_SIDED|95.0|-18.59|5.15||Threshold for significance at 0.05 level.|MMRM|||||5.15|-18.59|0.2657
71743467|NCT03201419|142997720|SUPERIORITY||Mean Difference|9.2||||0.1383|TWO_SIDED|95.0|-2.99|21.38||Threshold for significance at 0.05 level.|MMRM|||||21.38|-2.99|0.1383
71743468|NCT03201419|142997720|SUPERIORITY||Mean Difference|14.72||||0.0523|TWO_SIDED|95.0|-0.15|29.59||Threshold for significance at 0.05 level.|MMRM|||||29.59|-0.15|0.0523
71743469|NCT03201419|142997720|SUPERIORITY||Mean Difference|1.14||||0.8855|TWO_SIDED|95.0|-14.47|16.75||Threshold for significance at 0.05 level.|MMRM|||||16.75|-14.47|0.8855
71743470|NCT03201419|142997720|SUPERIORITY||Mean Difference|2.91||||0.5972|TWO_SIDED|95.0|-7.91|13.72||Threshold for significance at 0.05 level.|MMRM|||||13.72|-7.91|0.5972
71743471|NCT03201419|142997721|SUPERIORITY||Mean Difference|-0.54|||||TWO_SIDED|95.0|-6.09|2.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||2.28|-6.09|
71743472|NCT03201419|142997721|SUPERIORITY||Mean Difference|-0.28|||||TWO_SIDED|95.0|-4.3|0.75||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.75|-4.30|
71743473|NCT03201419|142997721|SUPERIORITY||Mean Difference|-0.15|||||TWO_SIDED|95.0|-2.44|0.33||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.33|-2.44|
71743474|NCT03201419|142997721|SUPERIORITY||Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.92|0.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.07|-0.92|
71743475|NCT03201419|142997721|SUPERIORITY||Mean Difference|-0.02|||||TWO_SIDED|95.0|-0.48|0.02||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.02|-0.48|
71743476|NCT03201419|142997721|SUPERIORITY||Mean Difference|0.0|||||TWO_SIDED|95.0|-0.15|0.0||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||0.00|-0.15|
71743477|NCT03201419|142997722|SUPERIORITY||Mean Difference|-0.27||||0.055|TWO_SIDED|95.0|-0.545|0.006||Threshold for significance at 0.05 level.|MMRM|||||0.006|-0.545|0.0550
71743478|NCT03201419|142997722|SUPERIORITY||Mean Difference|-0.7||||0.0002|TWO_SIDED|95.0|-1.066|-0.335||Threshold for significance at 0.05 level.|MMRM|||||-0.335|-1.066|0.0002
71743479|NCT03201419|142997722|SUPERIORITY||Mean Difference|-0.037||||0.844|TWO_SIDED|95.0|-0.404|0.33||Threshold for significance at 0.05 level.|MMRM|||||0.330|-0.404|0.8440
71743480|NCT03201419|142997722|SUPERIORITY||Mean Difference|0.041||||0.861|TWO_SIDED|95.0|-0.417|0.498||Threshold for significance at 0.05 level.|MMRM|||||0.498|-0.417|0.8610
71743481|NCT03201419|142997722|SUPERIORITY||Mean Difference|0.036||||0.8871|TWO_SIDED|95.0|-0.46|0.532||Threshold for significance at 0.05 level.|MMRM|||||0.532|-0.460|0.8871
71743482|NCT03201419|142997722|SUPERIORITY||Mean Difference|0.013||||0.9396|TWO_SIDED|95.0|-0.313|0.338||Threshold for significance at 0.05 level.|MMRM|||||0.338|-0.313|0.9396
71743483|NCT03201419|142997723|SUPERIORITY||Mean Difference|-0.475||||0.005|TWO_SIDED|95.0|-0.806|-0.145||Threshold for significance at 0.05 level.|MMRM|||||-0.145|-0.806|0.0050
71743484|NCT03201419|142997723|SUPERIORITY||Mean Difference|-0.405||||0.0665|TWO_SIDED|95.0|-0.837|0.028||Threshold for significance at 0.05 level.|MMRM|||||0.028|-0.837|0.0665
71743485|NCT03201419|142997723|SUPERIORITY||Mean Difference|-0.149||||0.5245|TWO_SIDED|95.0|-0.608|0.31||Threshold for significance at 0.05 level.|MMRM|||||0.310|-0.608|0.5245
71743486|NCT03201419|142997723|SUPERIORITY||Mean Difference|-0.075||||0.7947|TWO_SIDED|95.0|-0.642|0.492||Threshold for significance at 0.05 level.|MMRM|||||0.492|-0.642|0.7947
71743487|NCT03201419|142997723|SUPERIORITY||Mean Difference|-0.211||||0.4625|TWO_SIDED|95.0|-0.777|0.355||Threshold for significance at 0.05 level.|MMRM|||||0.355|-0.777|0.4625
71743488|NCT03201419|142997723|SUPERIORITY||Mean Difference|-0.014||||0.9465|TWO_SIDED|95.0|-0.412|0.385||Threshold for significance at 0.05 level.|MMRM|||||0.385|-0.412|0.9465
71743489|NCT03201419|142997724|SUPERIORITY||Mean Difference|-0.73|||<|0.0001|TWO_SIDED|95.0|-1.078|-0.383||Threshold for significance at 0.05 level.|MMRM|||||-0.383|-1.078|<0.0001
71743490|NCT03201419|142997724|SUPERIORITY||Mean Difference|-0.686||||0.003|TWO_SIDED|95.0|-1.137|-0.236||Threshold for significance at 0.05 level.|MMRM|||||-0.236|-1.137|0.0030
71743491|NCT03201419|142997724|SUPERIORITY||Mean Difference|-0.045||||0.852|TWO_SIDED|95.0|-0.517|0.427||Threshold for significance at 0.05 level.|MMRM|||||0.427|-0.517|0.8520
71743492|NCT03201419|142997724|SUPERIORITY||Mean Difference|-0.287||||0.3205|TWO_SIDED|95.0|-0.856|0.281||Threshold for significance at 0.05 level.|MMRM|||||0.281|-0.856|0.3205
71743493|NCT03201419|142997724|SUPERIORITY||Mean Difference|-0.418||||0.1769|TWO_SIDED|95.0|-1.026|0.19||Threshold for significance at 0.05 level.|MMRM|||||0.190|-1.026|0.1769
71777432|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.29||||0.1391|TWO_SIDED|95.0|-0.65|0.06|||ANCOVA|||Week 8, Day 56||0.06|-0.65|0.1391
71777433|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.35||||0.2873|TWO_SIDED|95.0|-0.86|0.17|||ANCOVA|||Week 12, Day 84||0.17|-0.86|0.2873
71777434|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.54||||0.002|TWO_SIDED|95.0|-0.91|-0.16|||ANCOVA|||Week 12, Day 84||-0.16|-0.91|0.0020
71777435|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.54||||0.0016|TWO_SIDED|95.0|-0.92|-0.17|||ANCOVA|||Week 12, Day 84||-0.17|-0.92|0.0016
71777436|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.31||||0.005|TWO_SIDED|95.0|0.07|0.55|||ANCOVA|||Week 1, Day 7||0.55|0.07|0.0050
71777437|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.33||||0.002|TWO_SIDED|95.0|0.1|0.57|||ANCOVA|||Week 1, Day 7||0.57|0.10|0.0020
71777438|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.35||||0.0082|TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Week 2, Day 14||0.62|0.07|0.0082
71845273|NCT05886777|143204386|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.11|||||TWO_SIDED|97.5|0.807|1.515|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.515|0.807|
71777439|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.35||||0.0056|TWO_SIDED|95.0|0.08|0.63|||ANCOVA|||Week 2, Day 14||0.63|0.08|0.0056
71777440|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.5||||0.0004|TWO_SIDED|95.0|0.19|0.82|||ANCOVA|||Week 4, Day 28||0.82|0.19|0.0004
71743494|NCT03201419|142997724|SUPERIORITY||Mean Difference|-0.3||||0.1584|TWO_SIDED|95.0|-0.717|0.118||Threshold for significance at 0.05 level.|MMRM|||||0.118|-0.717|0.1584
71777441|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.52||||0.0002|TWO_SIDED|95.0|0.21|0.84|||ANCOVA|||Week 4, Day 28||0.84|0.21|0.0002
71777442|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.34||||0.065|TWO_SIDED|95.0|-0.01|0.69|||ANCOVA|||Week 8, Day 56||0.69|-0.01|0.0650
71743495|NCT03201419|142997725|SUPERIORITY||Mean Difference|-0.822|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.424||Threshold for significance at 0.05 level.|MMRM|||||-0.424|-1.220|<0.0001
71743496|NCT03201419|142997725|SUPERIORITY||Mean Difference|-0.818||||0.0019|TWO_SIDED|95.0|-1.331|-0.306||Threshold for significance at 0.05 level.|MMRM|||||-0.306|-1.331|0.0019
71743497|NCT03201419|142997725|SUPERIORITY||Mean Difference|0.167||||0.551|TWO_SIDED|95.0|-0.383|0.716||Threshold for significance at 0.05 level.|MMRM|||||0.716|-0.383|0.5510
71743498|NCT03201419|142997725|SUPERIORITY||Mean Difference|-0.038||||0.9086|TWO_SIDED|95.0|-0.685|0.61||Threshold for significance at 0.05 level.|MMRM|||||0.610|-0.685|0.9086
71743499|NCT03201419|142997725|SUPERIORITY||Mean Difference|-0.812||||0.0185|TWO_SIDED|95.0|-1.486|-0.138||Threshold for significance at 0.05 level.|MMRM|||||-0.138|-1.486|0.0185
71743500|NCT03201419|142997725|SUPERIORITY||Mean Difference|-0.106||||0.6537|TWO_SIDED|95.0|-0.569|0.357||Threshold for significance at 0.05 level.|MMRM|||||0.357|-0.569|0.6537
71743501|NCT03201419|142997726|SUPERIORITY||Least Square Mean Difference|-0.146||||0.235|TWO_SIDED|95.0|-0.388|0.096||Threshold for significance at 0.05 level.|MMRM|||||0.096|-0.388|0.2350
71743502|NCT03201419|142997726|SUPERIORITY||Least Square Mean Difference|-0.377||||0.0215|TWO_SIDED|95.0|-0.699|-0.056||Threshold for significance at 0.05 level.|MMRM|||||-0.056|-0.699|0.0215
71777443|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.37||||0.0365|TWO_SIDED|95.0|0.02|0.72|||ANCOVA|||Week 8, Day 56||0.72|0.02|0.0365
71777444|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.09||||0.9338|TWO_SIDED|95.0|-0.28|0.47|||ANCOVA|||Week 12, Day 84||0.47|-0.28|0.9338
71777445|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|0.09||||0.952|TWO_SIDED|95.0|-0.29|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.29|0.9520
71777446|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.19||||0.1496|TWO_SIDED|95.0|-0.45|0.07|||ANCOVA|||Week 1, Day 7||0.07|-0.45|0.1496
71777447|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.13||||0.3936|TWO_SIDED|95.0|-0.43|0.17|||ANCOVA|||Week 2, Day 14||0.17|-0.43|0.3936
71777448|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.35||||0.0346|TWO_SIDED|95.0|-0.68|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.68|0.0346
71777449|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.68||||0.0004|TWO_SIDED|95.0|-1.04|-0.31|||ANCOVA|||Week 8, Day 56||-0.31|-1.04|0.0004
71777450|NCT02833350|143054242|SUPERIORITY||Adjusted Difference|-0.73||||0.0003|TWO_SIDED|95.0|-1.11|-0.34|||ANCOVA|||Week 12, Day 84||-0.34|-1.11|0.0003
71777451|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.17||||0.6083|TWO_SIDED|95.0|-0.53|0.19|||ANCOVA|||Week 1, Day 7||0.19|-0.53|0.6083
71777452|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.18||||0.2672|TWO_SIDED|95.0|-0.44|0.08|||ANCOVA|||Week 1, Day 7||0.08|-0.44|0.2672
71777453|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.17||||0.3158|TWO_SIDED|95.0|-0.43|0.09|||ANCOVA|||Week 1, Day 7||0.09|-0.43|0.3158
71777454|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.14||||0.8495|TWO_SIDED|95.0|-0.55|0.28|||ANCOVA|||Week 2, Day 14||0.28|-0.55|0.8495
71777455|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.28||||0.0856|TWO_SIDED|95.0|-0.58|0.03|||ANCOVA|||Week 2, Day 14||0.03|-0.58|0.0856
71777456|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.27||||0.1021|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA|||Week 2, Day 14||0.04|-0.57|0.1021
71777457|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.33||||0.2762|TWO_SIDED|95.0|-0.82|0.15|||ANCOVA|||Week 4, Day 28||0.15|-0.82|0.2762
71743503|NCT03201419|142997726|SUPERIORITY||Least Square Mean Difference|-0.218||||0.1818|TWO_SIDED|95.0|-0.54|0.103||Threshold for significance at 0.05 level.|MMRM|||||0.103|-0.540|0.1818
71743504|NCT03201419|142997726|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8063|TWO_SIDED|95.0|-0.45|0.35||Threshold for significance at 0.05 level.|MMRM|||||0.350|-0.450|0.8063
71743505|NCT03201419|142997726|SUPERIORITY||Least Square Mean Difference|0.176||||0.4414|TWO_SIDED|95.0|-0.274|0.627||Threshold for significance at 0.05 level.|MMRM|||||0.627|-0.274|0.4414
71743506|NCT03201419|142997726|SUPERIORITY||Least Square Mean Difference|-0.126||||0.4179|TWO_SIDED|95.0|-0.432|0.18||Threshold for significance at 0.05 level.|MMRM|||||0.180|-0.432|0.4179
71743507|NCT03201419|142997727|SUPERIORITY||Least Square Mean Difference|0.061||||0.6042|TWO_SIDED|95.0|-0.17|0.292||Threshold for significance at 0.05 level.|MMRM|||||0.292|-0.170|0.6042
71743508|NCT03201419|142997727|SUPERIORITY||Least Square Mean Difference|-0.127||||0.4114|TWO_SIDED|95.0|-0.432|0.177||Threshold for significance at 0.05 level.|MMRM|||||0.177|-0.432|0.4114
71743509|NCT03201419|142997727|SUPERIORITY||Least Square Mean Difference|0.099||||0.5394|TWO_SIDED|95.0|-0.219|0.418||Threshold for significance at 0.05 level.|MMRM|||||0.418|-0.219|0.5394
71743510|NCT03201419|142997727|SUPERIORITY||Least Square Mean Difference|0.149||||0.459|TWO_SIDED|95.0|-0.246|0.544||Threshold for significance at 0.05 level.|MMRM|||||0.544|-0.246|0.4590
71743511|NCT03201419|142997727|SUPERIORITY||Least Square Mean Difference|0.242||||0.2397|TWO_SIDED|95.0|-0.163|0.647||Threshold for significance at 0.05 level.|MMRM|||||0.647|-0.163|0.2397
71743512|NCT03201419|142997727|SUPERIORITY||Least Square Mean Difference|-0.039||||0.7954|TWO_SIDED|95.0|-0.332|0.254||Threshold for significance at 0.05 level.|MMRM|||||0.254|-0.332|0.7954
71777458|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.38||||0.0286|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0286
71777459|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.38||||0.0274|TWO_SIDED|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28||-0.03|-0.73|0.0274
71777460|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.28||||0.4981|TWO_SIDED|95.0|-0.81|0.24|||ANCOVA|||Week 8, Day 56||0.24|-0.81|0.4981
71777461|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.39||||0.0472|TWO_SIDED|95.0|-0.78|0.0|||ANCOVA|||Week 8, Day 56||-0.00|-0.78|0.0472
71743513|NCT03201419|142997728|SUPERIORITY||Least Square Mean Difference|-0.332||||0.0077|TWO_SIDED|95.0|-0.576|-0.089||Threshold for significance at 0.05 level.|MMRM|||||-0.089|-0.576|0.0077
71743514|NCT03201419|142997728|SUPERIORITY||Least Square Mean Difference|-0.61||||0.0002|TWO_SIDED|95.0|-0.927|-0.293||Threshold for significance at 0.05 level.|MMRM|||||-0.293|-0.927|0.0002
71743515|NCT03201419|142997728|SUPERIORITY||Least Square Mean Difference|-0.026||||0.8778|TWO_SIDED|95.0|-0.352|0.301||Threshold for significance at 0.05 level.|MMRM|||||0.301|-0.352|0.8778
71743516|NCT03201419|142997728|SUPERIORITY||Least Square Mean Difference|0.157||||0.4309|TWO_SIDED|95.0|-0.235|0.549||Threshold for significance at 0.05 level.|MMRM|||||0.549|-0.235|0.4309
71743517|NCT03201419|142997728|SUPERIORITY||Least Square Mean Difference|-0.017||||0.9392|TWO_SIDED|95.0|-0.444|0.411||Threshold for significance at 0.05 level.|MMRM|||||0.411|-0.444|0.9392
71743518|NCT03201419|142997728|SUPERIORITY||Least Square Mean Difference|-0.213||||0.1734|TWO_SIDED|95.0|-0.521|0.094||Threshold for significance at 0.05 level.|MMRM|||||0.094|-0.521|0.1734
71743519|NCT03201419|142997729|SUPERIORITY||Least Square Mean Difference|-0.328||||0.0133|TWO_SIDED|95.0|-0.587|-0.069||Threshold for significance at 0.05 level.|MMRM|||||-0.069|-0.587|0.0133
71743520|NCT03201419|142997729|SUPERIORITY||Least Square Mean Difference|-0.484||||0.0048|TWO_SIDED|95.0|-0.819|-0.15||Threshold for significance at 0.05 level.|MMRM|||||-0.150|-0.819|0.0048
71743521|NCT03201419|142997729|SUPERIORITY||Least Square Mean Difference|-0.04||||0.8223|TWO_SIDED|95.0|-0.395|0.314||Threshold for significance at 0.05 level.|MMRM|||||0.314|-0.395|0.8223
71743522|NCT03201419|142997729|SUPERIORITY||Least Square Mean Difference|0.215||||0.3083|TWO_SIDED|95.0|-0.2|0.63||Threshold for significance at 0.05 level.|MMRM|||||0.630|-0.200|0.3083
71743523|NCT03201419|142997729|SUPERIORITY||Least Square Mean Difference|-0.315||||0.1556|TWO_SIDED|95.0|-0.75|0.121||Threshold for significance at 0.05 level.|MMRM|||||0.121|-0.750|0.1556
71743524|NCT03201419|142997729|SUPERIORITY||Least Square Mean Difference|-0.188||||0.2423|TWO_SIDED|95.0|-0.504|0.128||Threshold for significance at 0.05 level.|MMRM|||||0.128|-0.504|0.2423
71743525|NCT03201419|142997730|SUPERIORITY||Least Square Mean Difference|-0.079||||0.6381|TWO_SIDED|95.0|-0.409|0.251||Threshold for significance at 0.05 level.|MMRM|||||0.251|-0.409|0.6381
71743526|NCT03201419|142997730|SUPERIORITY||Least Square Mean Difference|-0.502||||0.0221|TWO_SIDED|95.0|-0.931|-0.073||Threshold for significance at 0.05 level.|MMRM|||||-0.073|-0.931|0.0221
71743527|NCT03201419|142997730|SUPERIORITY||Least Square Mean Difference|-0.177||||0.4112|TWO_SIDED|95.0|-0.602|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.602|0.4112
71743528|NCT03201419|142997730|SUPERIORITY||Least Square Mean Difference|0.112||||0.6761|TWO_SIDED|95.0|-0.416|0.64||Threshold for significance at 0.05 level.|MMRM|||||0.640|-0.416|0.6761
71743529|NCT03201419|142997730|SUPERIORITY||Least Square Mean Difference|0.224||||0.4898|TWO_SIDED|95.0|-0.414|0.861||Threshold for significance at 0.05 level.|MMRM|||||0.861|-0.414|0.4898
71743530|NCT03201419|142997730|SUPERIORITY||Least Square Mean Difference|0.194||||0.3311|TWO_SIDED|95.0|-0.198|0.585||Threshold for significance at 0.05 level.|MMRM|||||0.585|-0.198|0.3311
71743531|NCT03201419|142997731|SUPERIORITY||Least Square Mean Difference|-0.23||||0.1583|TWO_SIDED|95.0|-0.551|0.09||Threshold for significance at 0.05 level.|MMRM|||||0.090|-0.551|0.1583
71743532|NCT03201419|142997731|SUPERIORITY||Least Square Mean Difference|-0.275||||0.1884|TWO_SIDED|95.0|-0.685|0.136||Threshold for significance at 0.05 level.|MMRM|||||0.136|-0.685|0.1884
71743533|NCT03201419|142997731|SUPERIORITY||Least Square Mean Difference|-0.047||||0.8256|TWO_SIDED|95.0|-0.463|0.369||Threshold for significance at 0.05 level.|MMRM|||||0.369|-0.463|0.8256
71777462|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.36||||0.0753|TWO_SIDED|95.0|-0.75|0.03|||ANCOVA|||Week 8, Day 56||0.03|-0.75|0.0753
71777463|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.43||||0.1853|TWO_SIDED|95.0|-0.99|0.13|||ANCOVA|||Week 12, Day 84||0.13|-0.99|0.1853
71777464|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.62||||0.0009|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0009
71777465|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.62||||0.0008|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84||-0.21|-1.03|0.0008
71743534|NCT03201419|142997731|SUPERIORITY||Least Square Mean Difference|0.059||||0.8198|TWO_SIDED|95.0|-0.455|0.574||Threshold for significance at 0.05 level.|MMRM|||||0.574|-0.455|0.8198
71743535|NCT03201419|142997731|SUPERIORITY||Least Square Mean Difference|-0.431||||0.1793|TWO_SIDED|95.0|-1.061|0.199||Threshold for significance at 0.05 level.|MMRM|||||0.199|-1.061|0.1793
71743536|NCT03201419|142997731|SUPERIORITY||Least Square Mean Difference|-0.196||||0.3155|TWO_SIDED|95.0|-0.581|0.189||Threshold for significance at 0.05 level.|MMRM|||||0.189|-0.581|0.3155
71743537|NCT03201419|142997732|SUPERIORITY||Least Square Mean Difference|-0.241||||0.183|TWO_SIDED|95.0|-0.596|0.114||Threshold for significance at 0.05 level.|MMRM|||||0.114|-0.596|0.1830
71743538|NCT03201419|142997732|SUPERIORITY||Least Square Mean Difference|-0.313||||0.1618|TWO_SIDED|95.0|-0.751|0.126||Threshold for significance at 0.05 level.|MMRM|||||0.126|-0.751|0.1618
71743539|NCT03201419|142997732|SUPERIORITY||Least Square Mean Difference|-0.26||||0.2519|TWO_SIDED|95.0|-0.706|0.186||Threshold for significance at 0.05 level.|MMRM|||||0.186|-0.706|0.2519
71743540|NCT03201419|142997732|SUPERIORITY||Least Square Mean Difference|0.232||||0.4044|TWO_SIDED|95.0|-0.316|0.781||Threshold for significance at 0.05 level.|MMRM|||||0.781|-0.316|0.4044
71743541|NCT03201419|142997732|SUPERIORITY||Least Square Mean Difference|-0.28||||0.4348|TWO_SIDED|95.0|-0.986|0.426||Threshold for significance at 0.05 level.|MMRM|||||0.426|-0.986|0.4348
71743542|NCT03201419|142997732|SUPERIORITY||Least Square Mean Difference|-0.15||||0.4786|TWO_SIDED|95.0|-0.565|0.266||Threshold for significance at 0.05 level.|MMRM|||||0.266|-0.565|0.4786
71743543|NCT03201419|142997733|SUPERIORITY||Least Square Mean Difference|-0.223||||0.2412|TWO_SIDED|95.0|-0.598|0.151||Threshold for significance at 0.05 level.|MMRM|||||0.151|-0.598|0.2412
71743544|NCT03201419|142997733|SUPERIORITY||Least Square Mean Difference|-0.48||||0.0501|TWO_SIDED|95.0|-0.959|0.0||Threshold for significance at 0.05 level.|MMRM|||||0.000|-0.959|0.0501
71743545|NCT03201419|142997733|SUPERIORITY||Least Square Mean Difference|0.069||||0.7788|TWO_SIDED|95.0|-0.417|0.556||Threshold for significance at 0.05 level.|MMRM|||||0.556|-0.417|0.7788
71743546|NCT03201419|142997733|SUPERIORITY||Least Square Mean Difference|-0.111||||0.7111|TWO_SIDED|95.0|-0.698|0.477||Threshold for significance at 0.05 level.|MMRM|||||0.477|-0.698|0.7111
71777466|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.41||||0.0005|TWO_SIDED|95.0|0.15|0.67|||ANCOVA|||Week 1, Day 7||0.67|0.15|0.0005
71777467|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.42||||0.0003|TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Week 1, Day 7||0.68|0.16|0.0003
71743547|NCT03201419|142997733|SUPERIORITY||Least Square Mean Difference|-0.205||||0.5816|TWO_SIDED|95.0|-0.937|0.527||Threshold for significance at 0.05 level.|MMRM|||||0.527|-0.937|0.5816
71743548|NCT03201419|142997733|SUPERIORITY||Least Square Mean Difference|-0.152||||0.4981|TWO_SIDED|95.0|-0.595|0.29||Threshold for significance at 0.05 level.|MMRM|||||0.290|-0.595|0.4981
71743549|NCT03201419|142997734|SUPERIORITY||Least Square Mean Difference|-1.313||||0.1733|TWO_SIDED|95.0|-3.207|0.582||Threshold for significance at 0.05 level.|MMRM|||||0.582|-3.207|0.1733
71743550|NCT03201419|142997734|SUPERIORITY||Least Square Mean Difference|-1.375||||0.2538|TWO_SIDED|95.0|-3.745|0.994||Threshold for significance at 0.05 level.|MMRM|||||0.994|-3.745|0.2538
71743551|NCT03201419|142997734|SUPERIORITY||Least Square Mean Difference|-0.353||||0.7782|TWO_SIDED|95.0|-2.818|2.113||Threshold for significance at 0.05 level.|MMRM|||||2.113|-2.818|0.7782
71743552|NCT03201419|142997734|SUPERIORITY||Least Square Mean Difference|-0.151||||0.9218|TWO_SIDED|95.0|-3.182|2.88||Threshold for significance at 0.05 level.|MMRM|||||2.880|-3.182|0.9218
71743553|NCT03201419|142997734|SUPERIORITY||Least Square Mean Difference|0.767||||0.6823|TWO_SIDED|95.0|-2.923|4.457||Threshold for significance at 0.05 level.|MMRM|||||4.457|-2.923|0.6823
71743554|NCT03201419|142997734|SUPERIORITY||Least Square Mean Difference|-1.095||||0.3436|TWO_SIDED|95.0|-3.369|1.179||Threshold for significance at 0.05 level.|MMRM|||||1.179|-3.369|0.3436
71743555|NCT03201419|142997735|SUPERIORITY||Least Square Mean Difference|-1.235||||0.2042|TWO_SIDED|95.0|-3.146|0.676||Threshold for significance at 0.05 level.|MMRM|||||0.676|-3.146|0.2042
71743556|NCT03201419|142997735|SUPERIORITY||Least Square Mean Difference|-1.683||||0.1591|TWO_SIDED|95.0|-4.031|0.665||Threshold for significance at 0.05 level.|MMRM|||||0.665|-4.031|0.1591
71743557|NCT03201419|142997735|SUPERIORITY||Least Square Mean Difference|-0.285||||0.8168|TWO_SIDED|95.0|-2.708|2.138||Threshold for significance at 0.05 level.|MMRM|||||2.138|-2.708|0.8168
71743558|NCT03201419|142997735|SUPERIORITY||Least Square Mean Difference|-0.551||||0.7148|TWO_SIDED|95.0|-3.517|2.416||Threshold for significance at 0.05 level.|MMRM|||||2.416|-3.517|0.7148
71743559|NCT03201419|142997735|SUPERIORITY||Least Square Mean Difference|0.701||||0.7141|TWO_SIDED|95.0|-3.066|4.468||Threshold for significance at 0.05 level.|MMRM|||||4.468|-3.066|0.7141
71743560|NCT03201419|142997735|SUPERIORITY||Least Square Mean Difference|-0.759||||0.5041|TWO_SIDED|95.0|-2.995|1.477||Threshold for significance at 0.05 level.|MMRM|||||1.477|-2.995|0.5041
71743561|NCT03201419|142997736|SUPERIORITY||Least Square Mean Difference|-1.129||||0.2896|TWO_SIDED|95.0|-3.226|0.967||Threshold for significance at 0.05 level.|MMRM|||||0.967|-3.226|0.2896
71743562|NCT03201419|142997736|SUPERIORITY||Least Square Mean Difference|-2.652||||0.0498|TWO_SIDED|95.0|-5.301|-0.003||Threshold for significance at 0.05 level.|MMRM|||||-0.003|-5.301|0.0498
71743563|NCT03201419|142997736|SUPERIORITY||Least Square Mean Difference|0.323||||0.8159|TWO_SIDED|95.0|-2.409|3.055||Threshold for significance at 0.05 level.|MMRM|||||3.055|-2.409|0.8159
71743564|NCT03201419|142997736|SUPERIORITY||Least Square Mean Difference|0.485||||0.7719|TWO_SIDED|95.0|-2.809|3.779||Threshold for significance at 0.05 level.|MMRM|||||3.779|-2.809|0.7719
71743565|NCT03201419|142997736|SUPERIORITY||Least Square Mean Difference|1.676||||0.4193|TWO_SIDED|95.0|-2.407|5.76||Threshold for significance at 0.05 level.|MMRM|||||5.760|-2.407|0.4193
71743566|NCT03201419|142997736|SUPERIORITY||Least Square Mean Difference|-1.23||||0.3333|TWO_SIDED|95.0|-3.73|1.27||Threshold for significance at 0.05 level.|MMRM|||||1.270|-3.730|0.3333
71743567|NCT03201419|142997737|SUPERIORITY||Mean Difference|41.8||||0.0853|TWO_SIDED|95.0|-5.9|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-5.9|0.0853
71777468|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.39||||0.006|TWO_SIDED|95.0|0.09|0.69|||ANCOVA|||Week 2, Day 14||0.69|0.09|0.0060
71777469|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.4||||0.0039|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Week 2, Day 14||0.70|0.10|0.0039
71777470|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.18|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.18|0.0007
71743568|NCT03201419|142997737|SUPERIORITY||Mean Difference|105.9||||0.001|TWO_SIDED|95.0|43.4|168.4||Threshold for significance at 0.05 level.|MMRM|||||168.4|43.4|0.0010
71743569|NCT03201419|142997737|SUPERIORITY||Mean Difference|24.9||||0.4418|TWO_SIDED|95.0|-38.8|88.6||Threshold for significance at 0.05 level.|MMRM|||||88.6|-38.8|0.4418
71743570|NCT03201419|142997737|SUPERIORITY||Mean Difference|10.7||||0.7902|TWO_SIDED|95.0|-68.2|89.6||Threshold for significance at 0.05 level.|MMRM|||||89.6|-68.2|0.7902
71743571|NCT03201419|142997737|SUPERIORITY||Mean Difference|1.8||||0.9664|TWO_SIDED|95.0|-84.2|87.9||Threshold for significance at 0.05 level.|MMRM|||||87.9|-84.2|0.9664
71743572|NCT03201419|142997737|SUPERIORITY||Mean Difference|-29.8||||0.2977|TWO_SIDED|95.0|-85.9|26.4||Threshold for significance at 0.05 level.|MMRM|||||26.4|-85.9|0.2977
71743573|NCT03201419|142997738|SUPERIORITY||Mean Difference|14.3||||0.5523|TWO_SIDED|95.0|-33.0|61.5||Threshold for significance at 0.05 level.|MMRM|||||61.5|-33.0|0.5523
71743574|NCT03201419|142997738|SUPERIORITY||Mean Difference|60.8||||0.0556|TWO_SIDED|95.0|-1.5|123.0||Threshold for significance at 0.05 level.|MMRM|||||123.0|-1.5|0.0556
71743575|NCT03201419|142997738|SUPERIORITY||Mean Difference|-17.9||||0.5837|TWO_SIDED|95.0|-82.0|46.3||Threshold for significance at 0.05 level.|MMRM|||||46.3|-82.0|0.5837
71743576|NCT03201419|142997738|SUPERIORITY||Mean Difference|-60.7||||0.1363|TWO_SIDED|95.0|-140.7|19.3||Threshold for significance at 0.05 level.|MMRM|||||19.3|-140.7|0.1363
71743577|NCT03201419|142997738|SUPERIORITY||Mean Difference|-28.2||||0.4938|TWO_SIDED|95.0|-109.1|52.8||Threshold for significance at 0.05 level.|MMRM|||||52.8|-109.1|0.4938
71777471|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.53||||0.0007|TWO_SIDED|95.0|0.19|0.88|||ANCOVA|||Week 4, Day 28||0.88|0.19|0.0007
71777472|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.39||||0.045|TWO_SIDED|95.0|0.01|0.77|||ANCOVA|||Week 8, Day 56||0.77|0.01|0.0450
71777473|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.42||||0.0259|TWO_SIDED|95.0|0.04|0.8|||ANCOVA|||Week 8, Day 56||0.80|0.04|0.0259
71777474|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.06||||0.9881|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9881
71743578|NCT03201419|142997738|SUPERIORITY||Mean Difference|-54.7||||0.0535|TWO_SIDED|95.0|-110.2|0.8||Threshold for significance at 0.05 level.|MMRM|||||0.8|-110.2|0.0535
71743579|NCT03201419|142997739|SUPERIORITY||Mean Difference|-0.7||||0.9829|TWO_SIDED|95.0|-62.2|60.9||Threshold for significance at 0.05 level.|MMRM|||||60.9|-62.2|0.9829
71743580|NCT03201419|142997739|SUPERIORITY||Mean Difference|64.4||||0.1038|TWO_SIDED|95.0|-13.3|142.1||Threshold for significance at 0.05 level.|MMRM|||||142.1|-13.3|0.1038
71743581|NCT03201419|142997739|SUPERIORITY||Mean Difference|29.2||||0.4764|TWO_SIDED|95.0|-51.4|109.8||Threshold for significance at 0.05 level.|MMRM|||||109.8|-51.4|0.4764
71743582|NCT03201419|142997739|SUPERIORITY||Mean Difference|-24.2||||0.6204|TWO_SIDED|95.0|-120.5|72.0||Threshold for significance at 0.05 level.|MMRM|||||72.0|-120.5|0.6204
71743583|NCT03201419|142997739|SUPERIORITY||Mean Difference|2.2||||0.966|TWO_SIDED|95.0|-100.1|104.6||Threshold for significance at 0.05 level.|MMRM|||||104.6|-100.1|0.9660
71743584|NCT03201419|142997739|SUPERIORITY||Mean Difference|3.3||||0.9275|TWO_SIDED|95.0|-67.4|73.9||Threshold for significance at 0.05 level.|MMRM|||||73.9|-67.4|0.9275
71743585|NCT03201419|142997740|SUPERIORITY||Mean Difference|15.7||||0.5964|TWO_SIDED|95.0|-42.7|74.2||Threshold for significance at 0.05 level.|MMRM|||||74.2|-42.7|0.5964
71743586|NCT03201419|142997740|SUPERIORITY||Mean Difference|-2.8||||0.9418|TWO_SIDED|95.0|-78.5|72.9||Threshold for significance at 0.05 level.|MMRM|||||72.9|-78.5|0.9418
71743587|NCT03201419|142997740|SUPERIORITY||Mean Difference|18.0||||0.6452|TWO_SIDED|95.0|-58.8|94.7||Threshold for significance at 0.05 level.|MMRM|||||94.7|-58.8|0.6452
71743588|NCT03201419|142997740|SUPERIORITY||Mean Difference|-51.3||||0.2565|TWO_SIDED|95.0|-140.2|37.6||Threshold for significance at 0.05 level.|MMRM|||||37.6|-140.2|0.2565
71743589|NCT03201419|142997740|OTHER||Mean Difference|-21.6||||0.6605|TWO_SIDED|95.0|-118.6|75.4||Threshold for significance at 0.05 level.|MMRM|||||75.4|-118.6|0.6605
71743590|NCT03201419|142997740|SUPERIORITY||Mean Difference|3.4||||0.9191|TWO_SIDED|95.0|-62.6|69.4||Threshold for significance at 0.05 level.|MMRM|||||69.4|-62.6|0.9191
71743591|NCT03201419|142997741|SUPERIORITY||Mean Difference|17.52|||||TWO_SIDED|95.0|-6.19|62.09||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||62.09|-6.19|
71743592|NCT03201419|142997741|SUPERIORITY||Mean Difference|12.78|||||TWO_SIDED|95.0|-0.73|55.89||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||55.89|-0.73|
71743593|NCT03201419|142997741|SUPERIORITY||Mean Difference|8.5|||||TWO_SIDED|95.0|-0.14|47.28||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||47.28|-0.14|
71743594|NCT03201419|142997741|SUPERIORITY||Mean Difference|3.29|||||TWO_SIDED|95.0|-0.01|28.07||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||28.07|-0.01|
71743595|NCT03201419|142997741|SUPERIORITY||Mean Difference|1.74|||||TWO_SIDED|95.0|0.0|17.9||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||17.90|-0.00|
71743596|NCT03201419|142997741|SUPERIORITY||Mean Difference|0.68|||||TWO_SIDED|95.0|0.0|7.55||||||Based on a Bayesian analysis of a sigmoidal dose-response relationship.||7.55|-0.00|
71743597|NCT03201419|142997742|SUPERIORITY||Mean Difference|-0.173||||0.0196|TWO_SIDED|95.0|-0.318|-0.028||Threshold for significance at 0.05 level.|MMRM|||||-0.028|-0.318|0.0196
71743598|NCT03201419|142997742|SUPERIORITY||Mean Difference|-0.233||||0.0167|TWO_SIDED|95.0|-0.423|-0.043||Threshold for significance at 0.05 level.|MMRM|||||-0.043|-0.423|0.0167
71743599|NCT03201419|142997742|SUPERIORITY||Mean Difference|-0.208||||0.0352|TWO_SIDED|95.0|-0.401|-0.015||Threshold for significance at 0.05 level.|MMRM|||||-0.015|-0.401|0.0352
71743600|NCT03201419|142997742|SUPERIORITY||Mean Difference|-0.057||||0.6402|TWO_SIDED|95.0|-0.295|0.182||Threshold for significance at 0.05 level.|MMRM|||||0.182|-0.295|0.6402
71777475|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|0.06||||0.9891|TWO_SIDED|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84||0.46|-0.34|0.9891
71777476|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.29||||0.0463|TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Week 1, Day 7||-0.00|-0.57|0.0463
71777477|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.23||||0.1867|TWO_SIDED|95.0|-0.56|0.11|||ANCOVA|||Week 2, Day 14||0.11|-0.56|0.1867
71777478|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.44||||0.0213|TWO_SIDED|95.0|-0.81|-0.07|||ANCOVA|||Week 4, Day 28||-0.07|-0.81|0.0213
71777479|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.78||||0.0003|TWO_SIDED|95.0|-1.19|-0.37|||ANCOVA|||Week 8. Day 56||-0.37|-1.19|0.0003
71743601|NCT03201419|142997742|SUPERIORITY||Mean Difference|-0.121||||0.3602|TWO_SIDED|95.0|-0.381|0.139||Threshold for significance at 0.05 level.|MMRM|||||0.139|-0.381|0.3602
71777480|NCT02833350|143054243|SUPERIORITY||Adjusted Difference|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4|||ANCOVA|||Week 12, Day 84||-0.40|-1.24|0.0002
71777481|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
71777482|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
71777483|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|1.82||||0.3482|TWO_SIDED|95.0|-1.98|5.62|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.62|-1.98|0.3482
71777484|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.71|-6.51|0.8979
71777485|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.48|-4.30|0.5976
71777486|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|0.91||||0.6546|TWO_SIDED|95.0|-3.07|4.89|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.89|-3.07|0.6546
71777487|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|-0.8||||0.7988|TWO_SIDED|95.0|-6.95|5.35|||Cochran-Mantel-Haenszel|||Week 4 Day 28||5.35|-6.95|0.7988
71777488|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|0.01||||0.9975|TWO_SIDED|95.0|-4.35|4.36|||Cochran-Mantel-Haenszel|||Week 4 Day 28||4.36|-4.35|0.9975
71777489|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|4.55||||0.1185|TWO_SIDED|95.0|-1.16|10.25|||Cochran-Mantel-Haenszel|||Week 4, Day 28||10.25|-1.16|0.1185
71777490|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|-2.4||||0.4765|TWO_SIDED|95.0|-9.01|4.21|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.21|-9.01|0.4765
71777491|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|4.61||||0.1655|TWO_SIDED|95.0|-1.9|11.12|||Cochran-Mantel-Haenszel|||Week 8, Day 56||11.12|-1.90|0.1655
71777492|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|8.18||||0.0234|TWO_SIDED|95.0|1.11|15.26|||Cochran-Mantel-Haenszel|||Week 8, Day 56||15.26|1.11|0.0234
71777493|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|3.2||||0.549|TWO_SIDED|95.0|-7.27|13.67|||Cochran-Mantel-Haenszel|||Week 12, Day 84||13.67|-7.27|0.5490
71777494|NCT02833350|143054244|SUPERIORITY||Mean Difference (Net)|15.62||||0.0003|TWO_SIDED|95.0|7.22|24.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||24.03|7.22|0.0003
71743602|NCT03201419|142997742|SUPERIORITY||Mean Difference|0.074||||0.4018|TWO_SIDED|95.0|-0.099|0.247||Threshold for significance at 0.05 level.|MMRM|||||0.247|-0.099|0.4018
71743603|NCT03201419|142997743|SUPERIORITY||Mean Difference|-0.133||||0.1354|TWO_SIDED|95.0|-0.308|0.042||Threshold for significance at 0.05 level.|MMRM|||||0.042|-0.308|0.1354
71777495|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|10.91||||0.0044|TWO_SIDED|95.0|3.39|18.43|||Cochran-Mantel-Haenszel|||Week 12, Day 84||18.43|3.39|0.0044
71777496|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
71777497|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 2, Day 14||9.99|-8.62|0.8853
71777498|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
71777499|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|0.68||||0.8853|TWO_SIDED|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 8, Day 56||9.99|-8.62|0.8853
71743604|NCT03201419|142997743|SUPERIORITY||Mean Difference|-0.091||||0.4238|TWO_SIDED|95.0|-0.315|0.133||Threshold for significance at 0.05 level.|MMRM|||||0.133|-0.315|0.4238
71777500|NCT02833350|143054244|SUPERIORITY||Adjusted Difference|11.64||||0.0584|TWO_SIDED|95.0|-0.41|23.7|||Cochran-Mantel-Haenszel|||Week 12, Day 84||23.70|-0.41|0.0584
71777501|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
71777502|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.92|-2.92|1.0000
71777503|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
71777504|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
71777505|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
71777506|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 2, Day 14||4.28|-2.47|0.5976
71777507|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.71|-6.51|0.8979
71777508|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|-0.91||||0.5976|TWO_SIDED|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 4 Day 28||2.48|-4.30|0.5976
71777509|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.91||||0.6669|TWO_SIDED|95.0|-3.23|5.05|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.05|-3.23|0.6669
71777510|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|-1.6||||0.6309|TWO_SIDED|95.0|-8.13|4.93|||Cochran-Mantel-Haenszel|||Week 8, Day 56||4.93|-8.13|0.6309
71777511|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|1.83||||0.4473|TWO_SIDED|95.0|-2.9|6.56|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.56|-2.90|0.4473
71777512|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|2.73||||0.3021|TWO_SIDED|95.0|-2.45|7.91|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.91|-2.45|0.3021
71777513|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|-1.6||||0.7134|TWO_SIDED|95.0|-10.14|6.94|||Cochran-Mantel-Haenszel|||Week 12, Day 84||6.94|-10.14|0.7134
71777514|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|3.7||||0.2635|TWO_SIDED|95.0|-2.79|10.19|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.19|-2.79|0.2635
71743605|NCT03201419|142997743|SUPERIORITY||Mean Difference|-0.22||||0.0574|TWO_SIDED|95.0|-0.446|0.007||Threshold for significance at 0.05 level.|MMRM|||||0.007|-0.446|0.0574
71743606|NCT03201419|142997743|SUPERIORITY||Mean Difference|0.058||||0.6579|TWO_SIDED|95.0|-0.199|0.315||Threshold for significance at 0.05 level.|MMRM|||||0.315|-0.199|0.6579
71743607|NCT03201419|142997743|SUPERIORITY||Mean Difference|-0.17||||0.2337|TWO_SIDED|95.0|-0.45|0.11||Threshold for significance at 0.05 level.|MMRM|||||0.110|-0.450|0.2337
71743608|NCT03201419|142997743|SUPERIORITY||Mean Difference|-0.136||||0.1639|TWO_SIDED|95.0|-0.328|0.056||Threshold for significance at 0.05 level.|MMRM|||||0.056|-0.328|0.1639
71777515|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|4.55||||0.1749|TWO_SIDED|95.0|-2.02|11.11|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.11|-2.02|0.1749
71777516|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|2.05||||0.6588|TWO_SIDED|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7||11.18|-7.07|0.6588
71777517|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.31|-8.31|1.0000
71777518|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.31|-8.31|1.0000
71777519|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
71777520|NCT02833350|143054245|SUPERIORITY||Adjusted Difference|1.37||||0.7848|TWO_SIDED|95.0|-8.46|11.2|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.20|-8.46|0.7848
71777521|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.28|6.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.28|-6.28|1.0000
71777522|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.93||||0.5941|TWO_SIDED|95.0|-2.5|4.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.37|-2.50|0.5941
71743609|NCT03201419|142997744|SUPERIORITY||Mean Difference|-87.2||||0.047|TWO_SIDED|95.0|-173.2|-1.2|||MMRM|||||-1.2|-173.2|0.0470
71743610|NCT03201419|142997744|SUPERIORITY||Mean Difference|-130.2||||0.0237|TWO_SIDED|95.0|-242.9|-17.6|||MMRM|||||-17.6|-242.9|0.0237
71743611|NCT03201419|142997744|SUPERIORITY||Mean Difference|-110.8||||0.0569|TWO_SIDED|95.0|-224.9|3.3|||MMRM|||||3.3|-224.9|0.0569
71777523|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.93|2.93|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.93|-2.93|1.0000
71777524|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.17|6.17|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.17|-6.17|1.0000
71777525|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.95|2.95|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.95|-2.95|1.0000
71777526|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
71777527|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|-0.43||||0.8929|TWO_SIDED|95.0|-6.62|5.77|||Cochran-Mantel-Haenszel|||Week 4, Day 28||5.77|-6.62|0.8929
71777528|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|-0.13||||0.9424|TWO_SIDED|95.0|-3.78|3.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||3.51|-3.78|0.9424
71777529|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|-0.94||||0.5927|TWO_SIDED|95.0|-4.4|2.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28||2.51|-4.40|0.5927
71777530|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|-0.46||||0.8788|TWO_SIDED|95.0|-6.31|5.4|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.40|-6.31|0.8788
71777531|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.87||||0.6876|TWO_SIDED|95.0|-3.36|5.09|||Cochran-Mantel-Haenszel|||Week 8 Day 56||5.09|-3.36|0.6876
71743612|NCT03201419|142997744|SUPERIORITY||Mean Difference|-23.9||||0.7383|TWO_SIDED|95.0|-164.8|117.0|||MMRM|||||117.0|-164.8|0.7383
71743613|NCT03201419|142997744|SUPERIORITY||Mean Difference|-71.0||||0.3626|TWO_SIDED|95.0|-224.3|82.3|||MMRM|||||82.3|-224.3|0.3626
71743614|NCT03201419|142997744|SUPERIORITY||Mean Difference|23.4||||0.6524|TWO_SIDED|95.0|-78.9|125.7|||MMRM|||||125.7|-78.9|0.6524
71743615|NCT03201419|142997745|SUPERIORITY||Mean Difference|-49.5||||0.3273|TWO_SIDED|95.0|-148.9|49.9||Threshold for significance at 0.05 level.|MMRM|||||49.9|-148.9|0.3273
71743616|NCT03201419|142997745|SUPERIORITY||Mean Difference|-74.6||||0.25|TWO_SIDED|95.0|-202.0|52.9||Threshold for significance at 0.05 level.|MMRM|||||52.9|-202.0|0.2500
71743617|NCT03201419|142997745|SUPERIORITY||Mean Difference|-93.5||||0.1537|TWO_SIDED|95.0|-222.3|35.2||Threshold for significance at 0.05 level.|MMRM|||||35.2|-222.3|0.1537
71743618|NCT03201419|142997745|SUPERIORITY||Mean Difference|33.6||||0.6515|TWO_SIDED|95.0|-113.1|180.3||Threshold for significance at 0.05 level.|MMRM|||||180.3|-113.1|0.6515
71743619|NCT03201419|142997745|SUPERIORITY||Mean Difference|-75.7||||0.3506|TWO_SIDED|95.0|-235.3|83.9||Threshold for significance at 0.05 level.|MMRM|||||83.9|-235.3|0.3506
71743620|NCT03201419|142997745|SUPERIORITY||Mean Difference|-85.4||||0.1255|TWO_SIDED|95.0|-194.8|24.1||Threshold for significance at 0.05 level.|MMRM|||||24.1|-194.8|0.1255
71743621|NCT02777827|142997766|SUPERIORITY||Least square mean|0.2221|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.1324|0.3118|||ANCOVA|||||0.3118|0.1324|<0.0001
71777532|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.97||||0.6656|TWO_SIDED|95.0|-3.42|5.35|||Cochran-Mantel-Haenszel|||Week 8, Day 56||5.35|-3.42|0.6656
71777533|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|-0.46||||0.8787|TWO_SIDED|95.0|-6.34|5.42|||Cochran-Mantel-Haenszel|||Week 12 Day 84||5.42|-6.34|0.8787
71777534|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.74||||0.7101|TWO_SIDED|95.0|-3.17|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-3.17|0.7101
71777535|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|3.2||||0.2425|TWO_SIDED|95.0|-2.16|8.55|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.55|-2.16|0.2425
71777536|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.68|8.68|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.68|-8.68|1.0000
71777537|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.39|8.39|||Cochran-Mantel-Haenszel|||Week 2 Day 14||8.39|-8.39|1.0000
71777538|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|2.03||||0.6658|TWO_SIDED|95.0|-7.17|11.22|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.22|-7.17|0.6658
71890917|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.83||||0.4874|TWO_SIDED|95.0|-18.66|8.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.99|-18.66|0.4874
71743622|NCT02777827|142997766|SUPERIORITY||Least Square Mean|0.4042|STANDARD_ERROR_OF_MEAN|0.0453|<|0.0001|TWO_SIDED|95.0|0.3146|0.4938|||ANCOVA|||||0.4938|0.3146|<0.0001
71743623|NCT02777827|142997766|SUPERIORITY||Least Square Mean|0.1056|STANDARD_ERROR_OF_MEAN|0.0451||0.0207|TWO_SIDED|95.0|0.0164|0.1949|||ANCOVA|||||0.1949|0.0164|0.0207
71743624|NCT02777827|142997766|SUPERIORITY||Least Square Mean|0.1701|STANDARD_ERROR_OF_MEAN|0.045||0.0002|TWO_SIDED|95.0|0.081|0.2592|||ANCOVA|||||0.2592|0.0810|0.0002
71743625|NCT02777827|142997766|SUPERIORITY||Least Square Mean|0.4062|STANDARD_ERROR_OF_MEAN|0.0451|<|0.0001|TWO_SIDED|95.0|0.317|0.4955|||ANCOVA|||||0.4955|0.3170|<0.0001
71743626|NCT00369577|142997790|SUPERIORITY|||||||0.088||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0880
71743627|NCT00369577|142997790|SUPERIORITY|||||||0.0002||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA|||||||0.0002
71743628|NCT00369577|142997791|SUPERIORITY|||||||0.0583|||||||Wilcoxon (Mann-Whitney)|||||||0.0583
71743629|NCT00369577|142997791|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71743630|NCT00369577|142997792|SUPERIORITY|||||||0.0067|||||||Wilcoxon (Mann-Whitney)|||||||0.0067
71743631|NCT00369577|142997792|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
71743632|NCT00369577|142997793|SUPERIORITY|||||||0.0076|||||||Fisher Exact|||||||0.0076
71743633|NCT00369577|142997793|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71743634|NCT04177212|142997809|OTHER||||||<|0.0001||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50 percent (%).|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||< 0.0001
71743635|NCT04177212|142997810|OTHER|||||||0.0003||||||P-value for testing null-hypothesis that response of Pooled Group was less or equal to 50%.|One-sided binomial test|||Between Groups calculation were not done because comparing Groups A and B was not part of the objective of this investigation.||||0.0003
71743636|NCT00857857|142997823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.1033|||TWO_SIDED|95.0|0.031|0.449||||||||0.449|0.031|
71743637|NCT00857857|142997823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.265|STANDARD_ERROR_OF_MEAN|0.1048|||TWO_SIDED|95.0|0.053|0.477||||||||0.477|0.053|
71743638|NCT00857857|142997823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|STANDARD_ERROR_OF_MEAN|0.0993|||TWO_SIDED|95.0|0.255|0.657||||||||0.657|0.255|
71743639|NCT00857857|142997823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.526|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|0.319|0.733||||||||0.733|0.319|
71743640|NCT00857857|142997824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.0975|||TWO_SIDED|95.0|0.013|0.407||||||||0.407|0.013|
71743641|NCT00857857|142997824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.0988|||TWO_SIDED|95.0|-0.046|0.354||||||||0.354|-0.046|
71743642|NCT00857857|142997824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.303|STANDARD_ERROR_OF_MEAN|0.0937|||TWO_SIDED|95.0|0.113|0.492||||||||0.492|0.113|
71743643|NCT00857857|142997824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.404|STANDARD_ERROR_OF_MEAN|0.0966|||TWO_SIDED|95.0|0.209|0.599||||||||0.599|0.209|
71743644|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.1372|||TWO_SIDED|95.0|-0.302|0.253|||||Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.302|
71777539|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.77|8.77|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.77|-8.77|1.0000
71777540|NCT02833350|143054246|SUPERIORITY||Adjusted Difference|6.57||||0.2457|TWO_SIDED|95.0|-4.52|17.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||17.66|-4.52|0.2457
71777541|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-2.36||||0.496|TWO_SIDED|95.0|-6.73|2.02|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.02|-6.73|0.4960
71777542|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-2.18||||0.2736|TWO_SIDED|95.0|-5.34|0.98|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.98|-5.34|0.2736
71777543|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-3.08||||0.0608|TWO_SIDED|95.0|-6.26|0.1|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.10|-6.26|0.0608
71777544|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-1.25||||0.9237|TWO_SIDED|95.0|-6.02|3.52|||Cochran-Mantel-Haenszel|||Week 2, Day 14||3.52|-6.02|0.9237
71777545|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-3.14||||0.0893|TWO_SIDED|95.0|-6.6|0.33|||Cochran-Mantel-Haenszel|||Week 2, Day 14||0.33|-6.60|0.0893
71777546|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-4.07||||0.0138|TWO_SIDED|95.0|-7.51|-0.63|||Cochran-Mantel-Haenszel|||Week 2, Day 14||-0.63|-7.51|0.0138
71777547|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-3.22||||0.3358|TWO_SIDED|95.0|-8.24|1.8|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.80|-8.24|0.3358
71777548|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-4.57||||0.0078|TWO_SIDED|95.0|-8.2|-0.94|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.94|-8.20|0.0078
71777549|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-4.68||||0.0059|TWO_SIDED|95.0|-8.3|-1.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.06|-8.30|0.0059
71777550|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-2.29||||0.6503|TWO_SIDED|95.0|-7.39|2.8|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.80|-7.39|0.6503
71777551|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-3.12||||0.1282|TWO_SIDED|95.0|-6.84|0.59|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.59|-6.84|0.1282
71777552|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-2.94||||0.1675|TWO_SIDED|95.0|-6.65|0.78|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.78|-6.65|0.1675
71777553|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-2.94||||0.422|TWO_SIDED|95.0|-7.96|2.09|||Cochran-Mantel-Haenszel|||Week 12, Day 84||2.09|-7.96|0.4220
71777554|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-5.1||||0.0027|TWO_SIDED|95.0|-8.77|-1.42|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.42|-8.77|0.0027
71777555|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-5.47||||0.0011|TWO_SIDED|95.0|-9.15|-1.78|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.78|-9.15|0.0011
71777556|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|3.21||||0.0455|TWO_SIDED|95.0|0.05|6.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.37|0.05|0.0455
71777557|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|2.31||||0.2309|TWO_SIDED|95.0|-0.87|5.48|||Cochran-Mantel-Haenszel|||Week 1, Day 7||5.48|-0.87|0.2309
71777558|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|3.27||||0.0698|TWO_SIDED|95.0|-0.18|6.72|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.72|-0.18|0.0698
71834326|NCT03821844|143172443|SUPERIORITY||Marginal Interaction Effect|-0.11|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|-0.3|0.08|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, antidepressant use, antianxietal use, antipsychotic use, nursing home corporation, time from Minimum Data Set (MDS) collection to Cohen-Mansfield Agitation Inventory (CMAI) score (exclusive to CMAI model), baseline Agitation and Reactive Behavior Score (ARBS) (exclusive to CMAI model), baseline CMAI (exclusive to ARBS and ARBS-CMAI model), indicator of baseline/follow-up score, treatment group, interaction of baseline/follow-up measure, and treatment group.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, random intercept for data collector (exclusive to CMAI model), and random intercept for individual."|0.08|-0.30|< 0.05
71890918|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.87||||0.2038|TWO_SIDED|95.0|-25.23|5.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||5.49|-25.23|0.2038
71890919|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.12||||0.1518|TWO_SIDED|95.0|-26.43|4.19|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||4.19|-26.43|0.1518
71743645|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.106|STANDARD_ERROR_OF_MEAN|0.1391|||TWO_SIDED|95.0|-0.176|0.387|||||Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.|||0.387|-0.176|
71743646|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.239|STANDARD_ERROR_OF_MEAN|0.1319|||TWO_SIDED|95.0|-0.028|0.506|||||Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.|||0.506|-0.028|
71743647|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.534|STANDARD_ERROR_OF_MEAN|0.1359|||TWO_SIDED|95.0|0.26|0.809|||||Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.809|0.260|
71743648|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.054|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|-0.145|0.253|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.|||0.253|-0.145|
71743649|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.176|0.228|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.|||0.228|-0.176|
71743650|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|-0.011|0.371|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.|||0.371|-0.011|
71777559|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|2.33||||0.2851|TWO_SIDED|95.0|-1.09|5.76|||Cochran-Mantel-Haenszel|||Week 2, Day 14||5.76|-1.09|0.2851
71777560|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|4.29||||0.0131|TWO_SIDED|95.0|0.69|7.9|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.90|0.69|0.0131
71777561|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|4.18||||0.0161|TWO_SIDED|95.0|0.59|7.78|||Cochran-Mantel-Haenszel|||Week 4, Day 28||7.78|0.59|0.0161
71743651|NCT00857857|142997825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.0978|||TWO_SIDED|95.0|0.153|0.548|||||Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.|||0.548|0.153|
71743652|NCT00857857|142997826|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.71|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.56|0.9||||||||0.90|0.56|
71743653|NCT00857857|142997826|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.66|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.53|0.82||||||||0.82|0.53|
71777562|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|3.85||||0.036|TWO_SIDED|95.0|0.18|7.51|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.51|0.18|0.0360
71743654|NCT00857857|142997826|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.59|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|95.0|0.47|0.74||||||||0.74|0.47|
71743655|NCT00857857|142997826|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.45|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.36|0.55||||||||0.55|0.36|
71743656|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.1086|||TWO_SIDED|95.0|-0.199|0.24|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes|||0.240|-0.199|
71743657|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.164|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.096|0.424|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes|||0.424|-0.096|
71743658|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.024|STANDARD_ERROR_OF_MEAN|0.1526|||TWO_SIDED|95.0|-0.285|0.333|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes|||0.333|-0.285|
71743659|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.1471|||TWO_SIDED|95.0|-0.229|0.366|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes|||0.366|-0.229|
71743660|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.011|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.277|0.254|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes|||0.254|-0.277|
71777563|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|4.04||||0.0252|TWO_SIDED|95.0|0.37|7.7|||Cochran-Mantel-Haenszel|||Week 8, Day 56||7.70|0.37|0.0252
71777564|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|1.03||||0.9032|TWO_SIDED|95.0|-2.59|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.66|-2.59|0.9032
71743661|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.269|0.302|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes|||0.302|-0.269|
71743662|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.1265|||TWO_SIDED|95.0|-0.21|0.301|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour|||0.301|-0.210|
71743663|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.1102|||TWO_SIDED|95.0|-0.178|0.268|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours|||0.268|-0.178|
71743664|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.096|STANDARD_ERROR_OF_MEAN|0.0985|||TWO_SIDED|95.0|-0.103|0.295|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours|||0.295|-0.103|
71743665|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045|STANDARD_ERROR_OF_MEAN|0.0826|||TWO_SIDED|95.0|-0.121|0.212|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours|||0.212|-0.121|
71743666|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0832|||TWO_SIDED|95.0|-0.141|0.196|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours|||0.196|-0.141|
71743667|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0888|||TWO_SIDED|95.0|-0.138|0.221|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours|||0.221|-0.138|
71743668|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0934|||TWO_SIDED|95.0|-0.215|0.162|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour|||0.162|-0.215|
71743669|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.139|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.076|0.354|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours|||0.354|-0.076|
71743670|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.149|STANDARD_ERROR_OF_MEAN|0.0955|||TWO_SIDED|95.0|-0.044|0.342|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours|||0.342|-0.044|
71777565|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|0.66||||0.9791|TWO_SIDED|95.0|-2.97|4.3|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.30|-2.97|0.9791
71777566|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-3.22||||0.0927|TWO_SIDED|95.0|-6.98|0.54|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.54|-6.98|0.0927
71777567|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-2.12||||0.3202|TWO_SIDED|95.0|-6.33|2.09|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.09|-6.33|0.3202
71777568|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-4.2||||0.0476|TWO_SIDED|95.0|-8.36|-0.04|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-0.04|-8.36|0.0476
71777569|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-9.93|||<|0.0001|TWO_SIDED|95.0|-14.31|-5.55|||Cochran-Mantel-Haenszel|||Week 8, Day 54||-5.55|-14.31|<0.0001
71777570|NCT02833350|143054247|SUPERIORITY||Adjusted Difference|-8.23||||0.0003|TWO_SIDED|95.0|-12.56|-3.9|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-3.90|-12.56|0.0003
71777571|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
71777572|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
71743671|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1005|||TWO_SIDED|95.0|-0.119|0.288|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours|||0.288|-0.119|
71743672|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.212|STANDARD_ERROR_OF_MEAN|0.1122|||TWO_SIDED|95.0|-0.015|0.438|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours|||0.438|-0.015|
71743673|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.1051|||TWO_SIDED|95.0|-0.051|0.374|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours|||0.374|-0.051|
71743674|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1181|||TWO_SIDED|95.0|-0.017|0.461|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour|||0.461|-0.017|
71743675|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|-0.089|0.458|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours|||0.458|-0.089|
71743676|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.1187|||TWO_SIDED|95.0|0.007|0.487|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours|||0.487|0.007|
71743677|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1313|||TWO_SIDED|95.0|-0.021|0.509|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours|||0.509|-0.021|
71743678|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1189|||TWO_SIDED|95.0|-0.086|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours|||0.394|-0.086|
71743679|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.175|STANDARD_ERROR_OF_MEAN|0.1085|||TWO_SIDED|95.0|-0.044|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours|||0.394|-0.044|
71777573|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.28|-2.47|0.5976
71777574|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
71777575|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
71777576|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
71777577|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
71777578|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
71777579|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
71777580|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
71777581|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
71743680|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.085|STANDARD_ERROR_OF_MEAN|0.1024|||TWO_SIDED|95.0|-0.122|0.292|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours|||0.292|-0.122|
71834327|NCT03821844|143172444|SUPERIORITY||average marginal effect|-3.61|STANDARD_ERROR_OF_MEAN|1.85|<|0.05|TWO_SIDED|95.0|-7.22|0.0|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.00|-7.22|< 0.05
71890920|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.25||||0.8567|TWO_SIDED|95.0|-14.98|12.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||12.49|-14.98|0.8567
71890921|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.01||||0.1493|TWO_SIDED|95.0|-4.06|26.08|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||26.08|-4.06|0.1493
71743681|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.1125|||TWO_SIDED|95.0|-0.155|0.3|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes|||0.300|-0.155|
71743682|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.051|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|-0.213|0.314|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes|||0.314|-0.213|
71743683|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.142|STANDARD_ERROR_OF_MEAN|0.1572|||TWO_SIDED|95.0|-0.176|0.461|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes|||0.461|-0.176|
71743684|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.094|STANDARD_ERROR_OF_MEAN|0.1494|||TWO_SIDED|95.0|-0.208|0.396|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes|||0.396|-0.208|
71743685|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.1332|||TWO_SIDED|95.0|-0.212|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes|||0.327|-0.212|
71743686|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.065|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.224|0.354|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes|||0.354|-0.224|
71743687|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.1283|||TWO_SIDED|95.0|-0.276|0.243|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour|||0.243|-0.276|
71743688|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.1118|||TWO_SIDED|95.0|-0.209|0.244|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours|||0.244|-0.209|
71743689|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.148|STANDARD_ERROR_OF_MEAN|0.0998|||TWO_SIDED|95.0|-0.35|0.053|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours|||0.053|-0.350|
71743690|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|95.0|-0.253|0.082|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours|||0.082|-0.253|
71743691|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.0843|||TWO_SIDED|95.0|-0.211|0.13|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours|||0.130|-0.211|
71743692|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.161|0.202|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours|||0.202|-0.161|
71743693|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.196|0.186|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour|||0.186|-0.196|
71743694|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.113|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|-0.105|0.33|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours|||0.330|-0.105|
71743695|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.0968|||TWO_SIDED|95.0|-0.065|0.326|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours|||0.326|-0.065|
71743696|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|-0.213|0.199|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours|||0.199|-0.213|
71743697|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.1138|||TWO_SIDED|95.0|-0.052|0.407|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours|||0.407|-0.052|
71743698|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.135|STANDARD_ERROR_OF_MEAN|0.1065|||TWO_SIDED|95.0|-0.08|0.351|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours|||0.351|-0.080|
71743699|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|95.0|-0.062|0.421|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour|||0.421|-0.062|
71743700|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.146|STANDARD_ERROR_OF_MEAN|0.1373|||TWO_SIDED|95.0|-0.131|0.423|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours|||0.423|-0.131|
71743701|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1203|||TWO_SIDED|95.0|-0.075|0.411|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours|||0.411|-0.075|
71743702|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|95.0|-0.047|0.49|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours|||0.490|-0.047|
71743703|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.143|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|-0.1|0.387|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours|||0.387|-0.100|
71743704|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.035|0.41|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours|||0.410|-0.035|
71743705|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.168|STANDARD_ERROR_OF_MEAN|0.1039|||TWO_SIDED|95.0|-0.042|0.378|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours|||0.378|-0.042|
71743706|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.221|STANDARD_ERROR_OF_MEAN|0.1036|||TWO_SIDED|95.0|0.011|0.431|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes|||0.431|0.011|
71743707|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.244|STANDARD_ERROR_OF_MEAN|0.1236|||TWO_SIDED|95.0|-0.006|0.494|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes|||0.494|-0.006|
71743708|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.255|STANDARD_ERROR_OF_MEAN|0.1445|||TWO_SIDED|95.0|-0.038|0.548|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes|||0.548|-0.038|
71743709|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.233|STANDARD_ERROR_OF_MEAN|0.1436|||TWO_SIDED|95.0|-0.057|0.524|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes|||0.524|-0.057|
71743710|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.219|STANDARD_ERROR_OF_MEAN|0.1262|||TWO_SIDED|95.0|-0.036|0.474|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes|||0.474|-0.036|
71743711|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.294|STANDARD_ERROR_OF_MEAN|0.1355|||TWO_SIDED|95.0|0.019|0.568|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes|||0.568|0.019|
71743712|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.227|STANDARD_ERROR_OF_MEAN|0.1216|||TWO_SIDED|95.0|-0.019|0.473|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour|||0.473|-0.019|
71743713|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1059|||TWO_SIDED|95.0|-0.01|0.418|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours|||0.418|-0.010|
71777582|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|5.45||||0.0286|TWO_SIDED|95.0|0.57|10.34|||Cochran-Mantel-Haenszel|||Week 8, Day 56||10.34|0.57|0.0286
71777583|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
71777584|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|4.57||||0.0708|TWO_SIDED|95.0|-0.39|9.52|||Cochran-Mantel-Haenszel|||Week 12, Day 84||9.52|-0.39|0.0708
71777585|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|5.45||||0.0478|TWO_SIDED|95.0|0.05|10.86|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.86|0.05|0.0478
71777586|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
71743714|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.116|STANDARD_ERROR_OF_MEAN|0.0947|||TWO_SIDED|95.0|-0.075|0.308|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours|||0.308|-0.075|
71743715|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.0805|||TWO_SIDED|95.0|-0.136|0.19|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours|||0.190|-0.136|
71777587|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
71743716|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|-0.116|0.208|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours|||0.208|-0.116|
71743717|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|STANDARD_ERROR_OF_MEAN|0.0855|||TWO_SIDED|95.0|-0.099|0.247|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour|||0.247|-0.099|
71743718|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.051|0.313|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours|||0.313|-0.051|
71743719|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1025|||TWO_SIDED|95.0|-0.004|0.411|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours|||0.411|-0.004|
71743720|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.181|STANDARD_ERROR_OF_MEAN|0.0918|||TWO_SIDED|95.0|-0.004|0.367|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours|||0.367|-0.004|
71743721|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.0967|||TWO_SIDED|95.0|-0.018|0.373|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours|||0.373|-0.018|
71743722|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.288|STANDARD_ERROR_OF_MEAN|0.1079|||TWO_SIDED|95.0|0.07|0.506|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours|||0.506|0.070|
71743723|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.283|STANDARD_ERROR_OF_MEAN|0.1011|||TWO_SIDED|95.0|0.079|0.488|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours|||0.488|0.079|
71743724|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.386|STANDARD_ERROR_OF_MEAN|0.1137|||TWO_SIDED|95.0|0.157|0.616|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour|||0.616|0.157|
71743725|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.1306|||TWO_SIDED|95.0|0.108|0.636|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours|||0.636|0.108|
71743726|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.458|STANDARD_ERROR_OF_MEAN|0.1142|||TWO_SIDED|95.0|0.227|0.688|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours|||0.688|0.227|
71743727|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.509|STANDARD_ERROR_OF_MEAN|0.1264|||TWO_SIDED|95.0|0.254|0.765|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours|||0.765|0.254|
71743728|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.492|STANDARD_ERROR_OF_MEAN|0.1144|||TWO_SIDED|95.0|0.261|0.723|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours|||0.723|0.261|
71743729|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.414|STANDARD_ERROR_OF_MEAN|0.1042|||TWO_SIDED|95.0|0.203|0.625|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours|||0.625|0.203|
71743730|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.0984|||TWO_SIDED|95.0|0.241|0.639|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours|||0.639|0.241|
71777588|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
71777589|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|4.11||||0.3838|TWO_SIDED|95.0|-5.14|13.36|||Cochran-Mantel-Haenszel|||Week 8, Day 56||13.36|-5.14|0.3838
71743731|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.1056|||TWO_SIDED|95.0|0.135|0.562|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes|||0.562|0.135|
71834328|NCT03821844|143172445|SUPERIORITY||average marginal effect|-3.47|STANDARD_ERROR_OF_MEAN|2.08|<|0.05|TWO_SIDED|95.0|-7.55|0.06|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|0.06|-7.55|< 0.05
71834329|NCT03821844|143172446|SUPERIORITY||average marginal effect|-1.26|STANDARD_ERROR_OF_MEAN|2.05|<|0.05|TWO_SIDED|95.0|-5.28|2.76|||Differences-in-Differences regression||||Variables included in the model: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, agitation and reactive behavior (ARBS) score, date of assessment, treatment group, and facility-level random effect.|2.76|-5.28|< 0.05
71743732|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.494|STANDARD_ERROR_OF_MEAN|0.1273|||TWO_SIDED|95.0|0.237|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes|||0.751|0.237|
71743733|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.499|STANDARD_ERROR_OF_MEAN|0.1484|||TWO_SIDED|95.0|0.199|0.8|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes|||0.800|0.199|
71743734|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.274|0.872|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes|||0.872|0.274|
71743735|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.488|STANDARD_ERROR_OF_MEAN|0.1303|||TWO_SIDED|95.0|0.225|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes|||0.751|0.225|
71743736|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.1398|||TWO_SIDED|95.0|0.098|0.663|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes|||0.663|0.098|
71743737|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.342|STANDARD_ERROR_OF_MEAN|0.1254|||TWO_SIDED|95.0|0.089|0.596|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour|||0.596|0.089|
71743738|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.218|STANDARD_ERROR_OF_MEAN|0.1094|||TWO_SIDED|95.0|-0.003|0.439|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours|||0.439|-0.003|
71743739|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|STANDARD_ERROR_OF_MEAN|0.0974||||95.0|-0.07|0.323|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours|||0.323|-0.070|
71743740|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0818|||TWO_SIDED|95.0|-0.107|0.223|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours|||0.223|-0.107|
71743741|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.0821|||TWO_SIDED|95.0|-0.192|0.139|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours|||0.139|-0.192|
71743742|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.091|STANDARD_ERROR_OF_MEAN|0.0876|||TWO_SIDED|95.0|-0.085|0.268|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours|||0.268|-0.085|
71743743|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.102|0.269|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour|||0.269|-0.102|
71743744|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.249|STANDARD_ERROR_OF_MEAN|0.105|||TWO_SIDED|95.0|0.038|0.461|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours|||0.461|0.038|
71743745|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.238|STANDARD_ERROR_OF_MEAN|0.0945|||TWO_SIDED|95.0|0.047|0.429|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours|||0.429|0.047|
71743746|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315|STANDARD_ERROR_OF_MEAN|0.0995|||TWO_SIDED|95.0|0.114|0.516|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours|||0.516|0.114|
71743747|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1111|||TWO_SIDED|95.0|0.143|0.591|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours|||0.591|0.143|
71743748|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|0.151|0.571|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours|||0.571|0.151|
71743749|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.1168|||TWO_SIDED|95.0|0.131|0.602|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour|||0.602|0.131|
71743750|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.424|STANDARD_ERROR_OF_MEAN|0.1336|||TWO_SIDED|95.0|0.155|0.694|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours|||0.694|0.155|
71743751|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_ERROR_OF_MEAN|0.1174|||TWO_SIDED|95.0|0.319|0.793|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours|||0.793|0.319|
71743752|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.593|STANDARD_ERROR_OF_MEAN|0.1297||||95.0|0.331|0.854|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours|||0.854|0.331|
71834330|NCT03821844|143172448|SUPERIORITY||average marginal effect|-0.22|||<|0.05|TWO_SIDED|95.0|-1.14|0.7|||Differences-in-Differences regression||||Multilevel regression with covariates' adjustments was used to estimate the impact of the resident being in a treatment versus control nursing home on depressive symptoms.|0.70|-1.14|< 0.05
71845274|NCT05886777|143204387|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.0|||||TWO_SIDED|97.5|0.769|1.288|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.288|0.769|
71834331|NCT03821844|143172449|SUPERIORITY||marginal interaction effect|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Differences-in-Differences regression||Reported estimation details pertain to the None category.||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the behaviors of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction.|0.02|-0.03|< 0.05
71834332|NCT03821844|143172450|SUPERIORITY||marginal interaction effect|0.05|||<|0.05|TWO_SIDED|95.0|0.02|0.07|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.07|0.02|< 0.05
71890922|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.45||||0.4798|TWO_SIDED|95.0|-9.86|20.76|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||20.76|-9.86|0.4798
71743753|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.559|STANDARD_ERROR_OF_MEAN|0.1177|||TWO_SIDED|95.0|0.322|0.797|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours|||0.797|0.322|
71743754|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.522|STANDARD_ERROR_OF_MEAN|0.1076||||95.0|0.304|0.739|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours|||0.739|0.304|
71743755|NCT00857857|142997832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.514|STANDARD_ERROR_OF_MEAN|0.1017||||95.0|0.308|0.719|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours|||0.719|0.308|
71743756|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.295|STANDARD_ERROR_OF_MEAN|0.1038||||95.0|0.086|0.503|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7|||0.503|0.086|
71743757|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.185|STANDARD_ERROR_OF_MEAN|0.0884|||TWO_SIDED|95.0|0.007|0.363|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13|||0.363|0.007|
71743758|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.144|STANDARD_ERROR_OF_MEAN|0.1026|||TWO_SIDED|95.0|-0.062|0.351|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14|||0.351|-0.062|
71743759|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.0979|||TWO_SIDED|95.0|0.133|0.527|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7|||0.527|0.133|
71743760|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081|STANDARD_ERROR_OF_MEAN|0.0856|||TWO_SIDED|95.0|-0.092|0.253|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13|||0.253|-0.092|
71743761|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.076|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14|||0.327|-0.076|
71743762|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.297|STANDARD_ERROR_OF_MEAN|0.0976|||TWO_SIDED|95.0|0.1|0.493|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7|||0.493|0.100|
71743763|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.083|0.429|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13|||0.429|0.083|
71743764|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.462|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.262|0.662|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14|||0.662|0.262|
71743765|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.323|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.125|0.52|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7|||0.520|0.125|
71743766|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|0.057|0.402|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13|||0.402|0.057|
71743767|NCT00857857|142997834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.372|STANDARD_ERROR_OF_MEAN|0.0991|||TWO_SIDED|95.0|0.172|0.572|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14|||0.572|0.172|
71743768|NCT00857857|142997844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.482|||TWO_SIDED|95.0|-1.3|0.66|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||0.66|-1.30|
71743769|NCT00857857|142997844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-0.73|1.28|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||1.28|-0.73|
71743770|NCT00857857|142997844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.36|2.19|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.19|0.36|
71743771|NCT00857857|142997844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|0.469|||TWO_SIDED|95.0|0.84|2.75|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\[2\] = 1).|||2.75|0.84|
71743772|NCT02709330|142997877|OTHER|||||||0.99|||||||Kolmogorov-Smirnov Test|||Matched historical controls will be identified from the PatientsLikeMe database.||||0.99
71743773|NCT02709330|142997878|OTHER|||||||0.0748|||||||ANOVA|||||||0.0748
71743774|NCT02709330|142997879|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
71743775|NCT02709330|142997883|OTHER||||||<|1e-05|||||||Lin's Concordance|||||||<0.00001
71743776|NCT01454791|142997884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
71743777|NCT01454791|142997885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.6059|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.6059
71743778|NCT01454791|142997886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.705|TWO_SIDED||||||t-test, 2 sided||not significant|||||0.705
71743779|NCT00086047|142997947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_DEVIATION|8.8||0.007|TWO_SIDED|95.0|1.57|9.22|||Mixed Models Analysis|||||9.22|1.57|0.007
71743780|NCT01618669|142997978|NON_INFERIORITY_OR_EQUIVALENCE|If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.|Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.015|||TWO_SIDED|95.0|-0.06|0.0|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||-0.00|-0.06|
71743781|NCT01618669|142997980|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.|Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.14|0.11|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone|||0.11|-0.14|
71743782|NCT01618669|142997981|NON_INFERIORITY_OR_EQUIVALENCE|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.|Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.07|0.04||||||||0.04|-0.07|
71777590|NCT02833350|143054248|SUPERIORITY||Adjusted Difference|0.68||||0.9009|TWO_SIDED|95.0|-10.1|11.47|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.47|-10.10|0.9009
71777591|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-2.36||||0.5455|TWO_SIDED|95.0|-7.0|2.27|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.27|-7.00|0.5455
71777592|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-1.97||||0.4114|TWO_SIDED|95.0|-5.3|1.36|||Cochran-Mantel-Haenszel|||Week 1, Day 7||1.36|-5.30|0.4114
71777593|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-2.62||||0.1739|TWO_SIDED|95.0|-5.97|0.72|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.72|-5.97|0.1739
71834333|NCT03821844|143172451|SUPERIORITY||marginal interaction effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.03|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.03|< 0.05
71743783|NCT01618669|142997982|SUPERIORITY_OR_OTHER||Difference|0.02|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.03|0.06||||||||0.06|-0.03|
71743784|NCT01702558|142998011|SUPERIORITY||Difference in Response Rates|8.2||||0.336|TWO_SIDED|90.0|-4.5|20.9|||Fisher Exact||90% CI was estimated using Hauck-Anderson approach.|||20.9|-4.5|0.336
71743785|NCT03259087|142998067|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.07|1.47|||||GMR is ratio of Experimental Group / Healthy Group|||1.47|1.07|
71743786|NCT03259087|142998067|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.7|||||TWO_SIDED|90.0|1.42|2.02|||||GMR is ratio of Experimental Group / Healthy Group|||2.02|1.42|
71743787|NCT03259087|142998067|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.98|||||TWO_SIDED|90.0|2.2|4.04|||||GMR is ratio of Experimental Group / Healthy Group|||4.04|2.20|
71743788|NCT03259087|142998068|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|1.06|1.46|||||GMR is ratio of Experimental Group / Healthy Group|||1.46|1.06|
71743789|NCT03259087|142998068|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.68|||||TWO_SIDED|90.0|1.41|1.99|||||GMR is ratio of Experimental Group / Healthy Group|||1.99|1.41|
71743790|NCT03259087|142998068|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.91|||||TWO_SIDED|90.0|2.17|3.9|||||GMR is ratio of Experimental Group / Healthy Group|||3.90|2.17|
71743791|NCT03259087|142998069|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|1.04|1.4|||||GMR is ratio of Experimental Group / Healthy Group|||1.40|1.04|
71743792|NCT03259087|142998069|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.59|||||TWO_SIDED|90.0|1.36|1.86|||||GMR is ratio of Experimental Group / Healthy Group|||1.86|1.36|
71743793|NCT03259087|142998069|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.32|||||TWO_SIDED|90.0|1.82|2.97|||||GMR is ratio of Experimental Group / Healthy Group|||2.97|1.82|
71743794|NCT03259087|142998070|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.84|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.84|
71743795|NCT03259087|142998070|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.03|||||TWO_SIDED|90.0|0.9|1.18|||||GMR is ratio of Experimental Group / Healthy Group|||1.18|0.90|
71743796|NCT03259087|142998070|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.11|||||TWO_SIDED|90.0|0.95|1.29|||||GMR is ratio of Experimental Group / Healthy Group|||1.29|0.95|
71743797|NCT03259087|142998072|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.8|||||TWO_SIDED|90.0|0.68|0.94|||||GMR is ratio of Experimental Group / Healthy Group|||0.94|0.68|
71743798|NCT03259087|142998072|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.59|||||TWO_SIDED|90.0|0.49|0.7|||||GMR is ratio of Experimental Group / Healthy Group|||0.70|0.49|
71743799|NCT03259087|142998072|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.34|||||TWO_SIDED|90.0|0.25|0.45|||||GMR is ratio of Experimental Group / Healthy Group|||0.45|0.25|
71777594|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-0.94||||0.9761|TWO_SIDED|95.0|-5.93|4.06|||Cochran-Mantel-Haenszel|||Week 2, Week 14||4.06|-5.93|0.9761
71777595|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.18||||0.0998|TWO_SIDED|95.0|-6.78|0.41|||Cochran-Mantel-Haenszel|||Week 2, Week 14||0.41|-6.78|0.0998
71664501|NCT01564537|142842062|SUPERIORITY||Odds Ratio (OR)|1.3|||=|0.332|TWO_SIDED|95.0|0.69|2.45||P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).|Cochran-Mantel-Haenszel||Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.|||2.45|0.69|=0.332
71743800|NCT03259087|142998076|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.97|||||TWO_SIDED|90.0|3.26|4.82|||||GMR is ratio of Experimental Group / Healthy Group|||4.82|3.26|
71743801|NCT03259087|142998076|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.58|||||TWO_SIDED|90.0|1.3|1.92|||||GMR is ratio of Experimental Group / Healthy Group|||1.92|1.30|
71743802|NCT03259087|142998077|OTHER||Geometric Least Squares Mean Ratio (GMR)|3.63|||||TWO_SIDED|90.0|3.03|4.36|||||GMR is ratio of Experimental Group / Healthy Group|||4.36|3.03|
71743803|NCT03259087|142998077|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.46|||||TWO_SIDED|90.0|1.22|1.75|||||GMR is ratio of Experimental Group / Healthy Group|||1.75|1.22|
71743804|NCT03259087|142998078|OTHER||Geometric Least Squares Mean Ratio (GMR)|2.61|||||TWO_SIDED|90.0|2.23|3.06|||||GMR is ratio of Experimental Group / Healthy Group|||3.06|2.23|
71743805|NCT03259087|142998078|OTHER||Geometric Least Squares Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.95|1.25|||||GMR is ratio of Experimental Group / Healthy Group|||1.25|0.95|
71743806|NCT03259087|142998079|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.98|||||TWO_SIDED|90.0|0.84|1.14|||||GMR is ratio of Experimental Group / Healthy Group|||1.14|0.84|
71743807|NCT03259087|142998079|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
71743808|NCT03259087|142998080|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.99|||||TWO_SIDED|90.0|0.85|1.16|||||GMR is ratio of Experimental Group / Healthy Group|||1.16|0.85|
71743809|NCT03259087|142998080|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group|||1.20|0.75|
71743810|NCT03259087|142998081|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.25|||||TWO_SIDED|90.0|0.21|0.31|||||GMR is ratio of Experimental Group / Healthy Group|||0.31|0.21|
71743811|NCT03259087|142998081|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.63|||||TWO_SIDED|95.0|0.52|0.77|||||GMR is ratio of Experimental Group / Healthy Group|||0.77|0.52|
71743812|NCT03259087|142998085|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
71743813|NCT03259087|142998085|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
71664502|NCT01635218|142842063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|3.1|7.0||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.0|3.1|<0.05
71664503|NCT01635218|142842063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED|95.0|1.31|5.25||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.25|1.31|<0.05
71743814|NCT03259087|142998085|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
71743815|NCT03259087|142998086|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.75|||||TWO_SIDED|90.0|0.57|0.98|||||GMR is ratio of Experimental Group / Healthy Group|||0.98|0.57|
71743816|NCT03259087|142998086|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.4|||||TWO_SIDED|90.0|0.31|0.53|||||GMR is ratio of Experimental Group / Healthy Group|||0.53|0.31|
71743817|NCT03259087|142998086|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.13|||||TWO_SIDED|90.0|0.08|0.22|||||GMR is ratio of Experimental Group / Healthy Group|||0.22|0.08|
71743818|NCT03259087|142998087|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.9|||||TWO_SIDED|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group|||1.11|0.74|
71743819|NCT03259087|142998087|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.64|||||TWO_SIDED|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group|||0.88|0.47|
71743820|NCT03259087|142998087|OTHER||Geometric Least Squares Mean Ratio (GMR)|0.3|||||TWO_SIDED|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group|||0.43|0.21|
71743821|NCT04950465|142998104|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2639|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA|||||0.43|-0.12|0.2639
71743822|NCT04950465|142998105|SUPERIORITY|||||||0.6978|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.6978
71743823|NCT04950465|142998105|SUPERIORITY|||||||0.813|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.8130
71743824|NCT04950465|142998106|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7645|TWO_SIDED|95.0|-0.26|0.19|||ANCOVA|||||0.19|-0.26|0.7645
71743825|NCT04950465|142998107|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.114||0.9728|TWO_SIDED|95.0|-0.23|0.22|||ANCOVA|||Week 4||0.22|-0.23|0.9728
71743826|NCT04950465|142998107|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14||0.2968|TWO_SIDED|95.0|-0.13|0.42|||ANCOVA|||Week 8||0.42|-0.13|0.2968
71743827|NCT04950465|142998108|SUPERIORITY|||||||0.1682|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 4||||0.1682
71743828|NCT04950465|142998108|SUPERIORITY|||||||0.3937|||||||Van Elteren Test|Due to non-normal residual analyses from ANCOVA a Van Elteren Test was performed.||Week 8||||0.3937
71743829|NCT01379183|142998116|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71743830|NCT01379183|142998117|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANCOVA|||||||0.27
71743831|NCT01379183|142998118|SUPERIORITY_OR_OTHER|||||||0.96|||||||ANCOVA|||||||0.96
71743832|NCT01379183|142998119|SUPERIORITY_OR_OTHER|||||||0.71|||||||ANCOVA|||||||0.71
71743833|NCT01379183|142998120|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|||||||0.37
71743834|NCT01379183|142998121|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANCOVA|||||||0.12
71743835|NCT02562716|142998125|SUPERIORITY|||||||0.15|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.15
71743836|NCT02562716|142998125|SUPERIORITY|||||||0.14|||||||Log Rank|||For each arm, the observed 2-year overall survival (OS) was compared to the null hypothesis of 40%, assuming a 58% alternative hypothesis, 88% power, and a 1-sided significance of 0.05.||||.14
71743837|NCT01775371|142998133|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.6|1.5||The a priori threshold for statistical significance was 0.05.|Z-test 2-sided||The direction of the comparison is the Patient Controlled Analgesia minus the standard care group|The rate of change of NRS pain scores per hour was calculated using a mixed effects linear model. Time is represented as a linear spline with knot at 30 minutes to support the separate estimation of early and late phase rates of change. Fixed effects in the analysis includes study-group indicator, early and late phase time, and interactions between study-group and time. The principal hypothesis test was a z-test of the coefficient of the study group late phase interaction term.||1.5|0.6|<0.001
71743838|NCT01775371|142998134|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71743839|NCT01775371|142998135|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71743840|NCT01775371|142998136|OTHER|Responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||These outcomes are based on the nurses who took care of patients in the study||||<0.001
71743841|NCT01775371|142998137|OTHER|All responses occur with equal probability|||||<|0.001|||||||Chi-squared|One-sample chi-squared test of hypothesis that the responses occur with equal probability||This outcome is based on the physicians who took care of the patients in the study||||<0.001
71743842|NCT01425801|142998160|SUPERIORITY_OR_OTHER||Least Squares Mean DIfference|0.405|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.353|0.458|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.458|0.353|<0.0001
71743843|NCT01425801|142998160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.371|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.318|0.424|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.424|0.318|<0.0001
71743844|NCT01425801|142998160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.322|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.269|0.375|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.375|0.269|<0.0001
71743845|NCT01425801|142998160|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.274|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.221|0.327|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate||||0.327|0.221|<0.0001
71743846|NCT02868554|142998178|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.07|TWO_SIDED||||||ANOVA|||||||0.07
71777596|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.97||||0.0239|TWO_SIDED|95.0|-7.54|-0.39|||Cochran-Mantel-Haenszel|||Week 2, Week 14||-0.39|-7.54|0.0239
71777597|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.98||||0.2018|TWO_SIDED|95.0|-9.25|1.3|||Cochran-Mantel-Haenszel|||Week 4, Day 28||1.30|-9.25|0.2018
71777598|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-5.67||||0.0011|TWO_SIDED|95.0|-9.48|-1.87|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.87|-9.48|0.0011
71777599|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-5.27||||0.0026|TWO_SIDED|95.0|-9.06|-1.48|||Cochran-Mantel-Haenszel|||Week 4, Day 28||-1.48|-9.06|0.0026
71777600|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-2.47||||0.6336|TWO_SIDED|95.0|-7.84|2.9|||Cochran-Mantel-Haenszel|||Week 8, Day 56||2.90|-7.84|0.6336
71777601|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.49||||0.095|TWO_SIDED|95.0|-7.38|0.41|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.41|-7.38|0.0950
71777602|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.18||||0.1451|TWO_SIDED|95.0|-7.06|0.71|||Cochran-Mantel-Haenszel|||Week 8, Day 56||0.71|-7.06|0.1451
71777603|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.28||||0.3434|TWO_SIDED|95.0|-8.43|1.87|||Cochran-Mantel-Haenszel|||Week 12, Day 84||1.87|-8.43|0.3434
71743847|NCT02868554|142998179|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
71743848|NCT03710642|142998197|SUPERIORITY||Mean Difference (Net)|-0.008096||||0.9904|TWO_SIDED||||||Regression, Linear|||||||0.9904
71777604|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-5.45||||0.0016|TWO_SIDED|95.0|-9.23|-1.68|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-1.68|-9.23|0.0016
71777605|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-5.88||||0.0006|TWO_SIDED|95.0|-9.65|-2.1|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-2.10|-9.65|0.0006
71777606|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|4.64||||0.0025|TWO_SIDED|95.0|1.31|7.96|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.96|1.31|0.0025
71777607|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|3.98||||0.0129|TWO_SIDED|95.0|0.64|7.32|||Cochran-Mantel-Haenszel|||Week 1, Day 7||7.32|0.64|0.0129
71743849|NCT03710642|142998198|SUPERIORITY||Mean Difference (Net)|-11.54||||0.30328|TWO_SIDED||||||Regression, Linear|||||||0.30328
71743850|NCT03710642|142998199|SUPERIORITY||Mean Difference (Net)|0.31122||||0.21981|TWO_SIDED||||||Regression, Linear|||||||0.21981
71743851|NCT03710642|142998200|SUPERIORITY||Cox Proportional Hazard|-0.36277||||0.6366|TWO_SIDED||||||Regression, Cox|||||||0.6366
71743852|NCT03710642|142998201|SUPERIORITY||Slope|-0.12842|STANDARD_ERROR_OF_MEAN|1.39602||0.9267|TWO_SIDED||||||Regression, Logistic|||||||0.9267
71777608|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|4.04||||0.0206|TWO_SIDED|95.0|0.46|7.62|||Cochran-Mantel-Haenszel|||Week 2, Day 14||7.62|0.46|0.0206
71777609|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|3.26||||0.0841|TWO_SIDED|95.0|-0.3|6.82|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.82|-0.30|0.0841
71777610|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|4.67||||0.0088|TWO_SIDED|95.0|0.91|8.42|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.42|0.91|0.0088
71777611|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|5.07||||0.0034|TWO_SIDED|95.0|1.34|8.81|||Cochran-Mantel-Haenszel|||Week 4, Day 28||8.81|1.34|0.0034
71777612|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|4.55||||0.0138|TWO_SIDED|95.0|0.71|8.39|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.39|0.71|0.0138
71777613|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|4.85||||0.0073|TWO_SIDED|95.0|1.02|8.69|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.69|1.02|0.0073
71777614|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|1.29||||0.8284|TWO_SIDED|95.0|-2.46|5.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.03|-2.46|0.8284
71834334|NCT03821844|143172452|SUPERIORITY||average marginal effect|-0.01|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.01|-0.04|< 0.05
71834335|NCT03821844|143172453|SUPERIORITY||marginal interaction effect|0.01|||<|0.05|TWO_SIDED|95.0|-0.02|0.03|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment versus control nursing home had on the moods of nursing home residents. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. We report the marginal time by intervention interaction.|0.03|-0.02|< 0.05
71834336|NCT03821844|143172454|SUPERIORITY||marginal interaction effect|-0.02|||<|0.05|TWO_SIDED|95.0|-0.05|0.01|||Differences-in-Differences regression||||The intention-to-treat (ITT) analysis used Bayesian multi-level multinomial logit models to analyze the effect that being in a treatment vs. control NH had on the behaviors and moods of NH residents. The models were implemented separately for each mood. All models adjust for resident baseline covariates and the activity status of a resident during an observation. In addition, they include an individual-level effect to account for multiple observations for the same resident, and a facility level effect to account for variability in the outcomes for individuals residing in the same nursing homes. To address baseline differences in the proportion of individuals at each level of the ordinal outcomes between treatment and control groups, we report the marginal time by intervention interaction. We will refer to this estimand as the marginal interaction effect (MIE), which is sometimes known as the Difference in Differences estimand.|0.01|-0.05|< 0.05
71890923|NCT01587950|143303693|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.56||||0.4255|TWO_SIDED|95.0|-19.42|8.29|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.29|-19.42|0.4255
71664504|NCT01635218|142842064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.71||0.14|TWO_SIDED|95.0|-0.73|7.61||The statistical significant ANOVA result (p\<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||7.61|-0.73|0.14
71743853|NCT03710642|142998202|SUPERIORITY||Mean Difference (Net)|3.0694||||0.2038|TWO_SIDED||||||Regression, Linear|||||||0.2038
71743854|NCT03710642|142998203|SUPERIORITY||Mean Difference (Net)|-3.388||||0.54133|TWO_SIDED||||||Regression, Linear|||||||0.54133
71743855|NCT02538042|142998212|SUPERIORITY|||||||0.39|||||||ANOVA|||||||0.39
71743856|NCT02052752|142998288|SUPERIORITY_OR_OTHER|||||||0.283||95.0|||||ANCOVA|||The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population||||0.283
71743857|NCT02360228|142998330|OTHER|||||||0.47|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups.H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.47
71743858|NCT02360228|142998332|OTHER|||||||0.37|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the PANSS score from day 5 to baseline. H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)||||0.37
71743859|NCT02360228|142998333|OTHER|||||||0.11|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||"The null hypothesis was that there is no difference between the changes in the BACS score from baseline to 5 days between the groups:~H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)"||||0.11
71758520|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71777615|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|0.86||||0.9525|TWO_SIDED|95.0|-2.88|4.6|||Cochran-Mantel-Haenszel|||Week 12, Day 84||4.60|-2.88|0.9525
71777616|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-3.22||||0.0856|TWO_SIDED|95.0|-6.91|0.46|||Cochran-Mantel-Haenszel|||Week 1, Day 7||0.46|-6.91|0.0856
71743860|NCT01059318|142998339|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|76.0|||||TWO_SIDED|95.0|-45.0|196.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FVC change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||196|-45|
71743861|NCT01059318|142998340|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|186.0|||||TWO_SIDED|95.0|93.0|279.0|||Bayesian analysis|A Bayesian posterior distribution of the treatment effect at 26 weeks was evaluated using a non-informative prior.|MILES study and current study had different study designs, so change from baseline to 26 weeks in MILES study was estimated from the publicly reported rate of change per month in order to provide a meaningful comparison based on Bayesian analysis.|"Proof of Concept was proposed as follows:~* 90% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \> 0 mL~* 50% level of proof that difference in FEV1 change from baseline everolimus vs. Historical Placebo Control arm from MILES study \>= 100 mL~Historical data from 43 patients treated with placebo from the MILES study were down weighted to an effective sample size of 18 for comparison."||279|93|
71743862|NCT04186871|142998346|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-27.8|||||TWO_SIDED|95.0|-77.5|21.9||||||||21.9|-77.5|
71743863|NCT04186871|142998346|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.32||||0.3117|TWO_SIDED|95.0|0.04|2.73|||Cochran-Mantel-Haenszel|||||2.73|0.04|0.3117
71743864|NCT04186871|142998347|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||||4.9|-2.8|
71743865|NCT04186871|142998347|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-8.3|||||TWO_SIDED|95.0|-11.5|-5.0||||||||-5.0|-11.5|
71743866|NCT04186871|142998347|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 24|Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-9.3|-5.2||||||||-5.2|-9.3|
71743867|NCT04186871|142998348|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|16.7|||||TWO_SIDED|95.0|-31.8|65.2||||||||65.2|-31.8|
71743868|NCT04186871|142998348|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.22|18.04||||||||18.04|0.22|
71777617|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-2.08||||0.3374|TWO_SIDED|95.0|-6.36|2.2|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.20|-6.36|0.3374
71777618|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-4.24||||0.0534|TWO_SIDED|95.0|-8.53|0.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||0.06|-8.53|0.0534
71834337|NCT02605837|143172497|SUPERIORITY||Difference in proportion of responders|0.52|||<|0.001||95.0|0.433|0.591|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.591|0.433|<0.001
71743869|NCT04186871|142998349|SUPERIORITY|RESPONSE DIFFERENCE (95% CI) VS PLACEBO|Response Difference|-11.9|||||TWO_SIDED|95.0|-57.1|33.3||||||||33.3|-57.1|
71743870|NCT04186871|142998349|SUPERIORITY|ODDS RATIO (95% CI) VS PLACEBO|Odds Ratio (OR)|0.4||||0.593|TWO_SIDED|95.0|0.02|10.02|||Cochran-Mantel-Haenszel|||||10.02|0.02|0.5930
71743871|NCT04186871|142998350|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-14.6|||||TWO_SIDED|95.0|-36.9|7.7||||||||7.7|-36.9|
71743872|NCT04186871|142998350|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.46||||0.1639|TWO_SIDED|95.0|0.15|1.39|||Chi-squared|||||1.39|0.15|0.1639
71743873|NCT04186871|142998351|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE WEEK 12|Mean Difference (Final Values)|-1.61|||||TWO_SIDED|95.0|-2.11|-1.11||||||||-1.110|-2.110|
71743874|NCT04186871|142998351|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.567|||||TWO_SIDED|95.0|-1.855|-1.28||||||||-1.280|-1.855|
71743875|NCT04186871|142998351|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.534|0.62||||||||0.620|-0.534|
71743876|NCT04186871|142998352|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.741|||||TWO_SIDED|95.0|-2.256|-1.226||||||||-1.226|-2.256|
71743877|NCT04186871|142998352|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-1.698|||||TWO_SIDED|95.0|-1.998|-1.399||||||||-1.399|-1.998|
71743878|NCT04186871|142998352|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.043|||||TWO_SIDED|95.0|-0.553|0.639||||||||0.639|-0.553|
71743879|NCT04186871|142998353|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-19.495|||||TWO_SIDED|95.0|-24.861|-14.128||||||||-14.128|-24.861|
71743880|NCT04186871|142998353|EQUIVALENCE|ADJUSTED MEAN DIFFERENCE AT WEEK 12|Mean Difference (Final Values)|-18.767|||||TWO_SIDED|95.0|-21.848|-15.686||||||||-15.686|-21.848|
71777619|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.33|-6.32|||Cochran-Mantel-Haenszel|||Week 8, Day 56||-6.32|-15.33|<0.0001
71777620|NCT02833350|143054249|SUPERIORITY||Adjusted Difference|-9.22|||<|0.0001|TWO_SIDED|95.0|-13.63|-4.81|||Cochran-Mantel-Haenszel|||Week 12, Day 84||-4.81|-13.63|<0.0001
71777621|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7||6.06|-6.06|1.0000
71777622|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.91||||0.5976|TWO_SIDED|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7||4.30|-2.48|0.5976
71777623|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7||2.91|-2.91|1.0000
71777624|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14||6.06|-6.06|1.0000
71834338|NCT02605837|143172498|SUPERIORITY||Difference in proportion of responders|0.13||||0.024||95.0|0.016|0.243|||Cochran-Mantel-Haenszel|||The CMH adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.||0.243|0.016|0.024
71743881|NCT04186871|142998353|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.728|||||TWO_SIDED|95.0|-5.463|6.919||||||||6.919|-5.463|
71743882|NCT04186871|142998354|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-19.2|||||TWO_SIDED|95.0|-24.3|-14.1||||||||-14.1|-24.3|
71743883|NCT04186871|142998354|EQUIVALENCE|ADJUSTED MEAN AT DIFFERENCE WEEK 12|Mean Difference (Final Values)|-18.5|||||TWO_SIDED|95.0|-21.4|-15.5||||||||-15.5|-21.4|
71743884|NCT04186871|142998354|SUPERIORITY|ADJUSTED MEAN DIFFERENCE VS PLACEBO|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-5.2|6.6||||||||6.6|-5.2|
71743885|NCT04186871|142998355|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-4.1|||||TWO_SIDED|95.0|-28.1|19.9||||||||19.9|-28.1|
71743886|NCT04186871|142998355|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.31|2.32||||||||2.32|0.31|
71743887|NCT04186871|142998356|SUPERIORITY|RESPONSE DIFFERENCE VS PLACEBO|Response Difference|-6.5|||||TWO_SIDED|95.0|-22.8|9.9||||||||9.9|-22.8|
71743888|NCT04186871|142998356|SUPERIORITY|ODDS RATIO VS PLACEBO|Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.11|2.34||||||||2.34|0.11|
71743889|NCT01604291|142998385|OTHER|||||||0.9109||||||The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|Chi-squared|||Correlation between SVR 24 and Gender||||0.9109
71743890|NCT01604291|142998385|OTHER|||||||0.1163||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Age||||0.1163
71777625|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.92|-2.92|1.0000
71743891|NCT01604291|142998385|OTHER|||||||0.9269||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Height||||0.9269
71743892|NCT01604291|142998385|OTHER|||||||0.3376||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Weight||||0.3376
71743893|NCT01604291|142998385|OTHER|||||||0.4618||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Body mass index.||||0.4618
71743894|NCT01604291|142998398|OTHER||phi-coefficient|-0.0835||||0.0463|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables|Correlation with dose modification for Peginterferon alfa-2a.||||0.0463
71743895|NCT01604291|142998398|OTHER||phi-coefficient|0.0666||||0.2052|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Ribavirin.||||0.2052
71743896|NCT01604291|142998398|OTHER||phi-coefficient|-0.1672||||0.0033|||||||Fisher Exact|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Telaprevir/boceprevir.||||0.0033
71777626|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14||2.91|-2.91|1.0000
71743897|NCT01657292|142998399|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||1-sided, significance level = 0.025|Binomial test|||"All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 \>0.5 (with s0=rate of superiority of Oleogel-S10)."||||<0.0001
71743898|NCT00650845|142998410|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-7.9|6.7||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%Confidence Interval (CI) of the difference (non-enhanced - Dotarem®-enhanced) was \[-7.9%; +6.7%\]||6.7|-7.9|
71743899|NCT00650845|142998411|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.291
71743900|NCT00650845|142998412|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-14.1|8.9||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%CI of the difference (non-enhanced - Dotarem®-enhanced) was \[-14.1%; +8.9%\]||8.9|-14.1|
71777627|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28||6.06|-6.06|1.0000
71777628|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.91||||0.5726|TWO_SIDED|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.09|-2.26|0.5726
71777629|NCT02833350|143054250|SUPERIORITY||Mean Difference (Net)|0.91||||0.5976|TWO_SIDED|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28||4.28|-2.47|0.5976
71777630|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.06|-6.06|1.0000
71777631|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|2.74||||0.1446|TWO_SIDED|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56||6.42|-0.94|0.1446
71664505|NCT01635218|142842064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|1.73||0.99|TWO_SIDED|95.0|-2.93|5.5||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||5.5|-2.93|0.99
71890924|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.96||||0.7769||95.0|-15.71|11.8||ANCOVA with factors for treatment group, application site, period and random effect for subject.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.80|-15.71|0.7769
71743901|NCT00650845|142998413|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.||||0.040
71743902|NCT00650845|142998414|SUPERIORITY_OR_OTHER|||||||0.301|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.301
71743903|NCT00650845|142998415|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.||||0.051
71743904|NCT03932760|142998416|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.913|STANDARD_ERROR_OF_MEAN|1.085||0.612|TWO_SIDED|95.0|-1.228|3.055|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of EPDS between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum controlling for screening EPDS score. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher EPDS scores signify worsened symptoms of depression. Time uses start of study as reference controlling for screen EPDS.~Group VCI (AC reference): F=0.260, p=0.612~Time (Baseline as reference): F=9.021, p\<0.001~Group\*Time: F=0.537, p=0.748~Estimates for group, time, and group\*time interactions~Group:~Estimate=0.913 (SE=1.085) \[CI LB=-1.228, UB=3.055\]~Time:~Post: estimate=-2.766 (0.853) \[-4.445, -1.087\]~2 months: estimate=-1.517 (0.862) \[-3.214, 0.180\]~4 months: estimate=-3.186 (0.862) \[-4.883, -1.489\]~6 months: estimate=-2.781 (0.872) \[-4.498, -1.065\]~8 months: estimate=-3.103 (0.872) \[-4.819, -1.386\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|3.055|-1.228|0.612
71743905|NCT03932760|142998417|OTHER|Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.|Mean estimates by time|0.016|STANDARD_ERROR_OF_MEAN|0.859||0.558|TWO_SIDED|95.0|-1.709|1.677|||Mixed Models Analysis||Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.|We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of GAD-7 between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.|"Overall test of significance for Fixed Effects. Higher GAD-7 scores signify worsened symptoms of depression.~Group VCI (AC reference): F=0.347, p=0.558~Time (Baseline as reference): F=4.973, p\<0.001~Group\*Time: F=0.417, p=0.837~Estimates for group, time, and group\*time interactions~Group:~Estimate=-0.0160 (SE=0.859) \[CI LB=-1.709, UB=1.677\]~Time:~Post: estimate=-1.780 (0.708) \[-3.173, -0.387\]~2 months: estimate=-0.615 (0.715) \[-2.023, 0.792\]~4 months: estimate=-1.416 (0.715) \[-2.824, -0.008\]~6 months: estimate=-1.625 (0.723) \[-3.049, -0.201\]~8 months: estimate=-1.542 (0.723) \[-2.966, -0.118\]~Group\*Time:~Post: estimate=-1.157 (1.214) \[-3.547, 1.232\]~2 months: estimate=-1.361 (1.210) \[-3.742, 1.019\]~4 months: estimate= 0.183 (1.209) \[-2.196, 2.562\]~6 months: estimate=-0.508 (1.223) \[-2.914, 1.898\]~8 months: estimate=-0.127 (1.220) \[-2.529, 2.275\]"|1.677|-1.709|0.558
71743906|NCT01279681|142998472|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.93|TWO_SIDED|95.0|0.49|2.17|||Regression, Cox|||||2.17|0.49|0.93
71743907|NCT00181363|142998481|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71743908|NCT00181363|142998482|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71743909|NCT00181363|142998483|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71743910|NCT00181363|142998484|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71743911|NCT00181363|142998485|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71743912|NCT04640311|142998521|OTHER||Geometric mean ratio|1.028|||||TWO_SIDED|90.0|0.9699|1.09|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.090|0.9699|
71743913|NCT04640311|142998521|OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.9602|1.081|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.081|0.9602|
71743914|NCT04640311|142998522|EQUIVALENCE|Bioequivalence was to be determined if the 90 percent (%) confidence interval (CI) of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.029|||||TWO_SIDED|90.0|0.977|1.083|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.083|0.9770|
71664506|NCT01635218|142842065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.11|||<|0.05|TWO_SIDED|95.0|0.03|0.34|||Chi-squared|||||0.34|0.03|<0.05
71664507|NCT01635218|142842065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.05|TWO_SIDED|95.0|0.06|0.56|||Chi-squared|||||0.56|0.06|<0.05
71664508|NCT01635218|142842066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.42||0.002|TWO_SIDED|95.0|2.72|14.52||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||14.52|2.72|0.002
71743915|NCT04640311|142998522|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9496|||||TWO_SIDED|90.0|0.8914|1.012|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.012|0.8914|
71743916|NCT04640311|142998522|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.9533|1.07|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.070|0.9533|
71743917|NCT04640311|142998522|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9679|||||TWO_SIDED|90.0|0.9115|1.028|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.028|0.9115|
71777632|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|3.64||||0.105|TWO_SIDED|95.0|-0.76|8.03|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.03|-0.76|0.1050
71777633|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|-0.4||||0.8979|TWO_SIDED|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84||5.71|-6.51|0.8979
71777634|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|3.65||||0.127|TWO_SIDED|95.0|-1.04|8.35|||Cochran-Mantel-Haenszel|||Week 12, Day 84||8.35|-1.04|0.1270
71834339|NCT02605837|143172499|SUPERIORITY||Difference in Least square mean|-3.92||||0.015||95.0|-7.073|-0.774|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ combined score as a continuous covariate.||-0.774|-7.073|0.015
71743918|NCT04640311|142998522|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9511|||||TWO_SIDED|90.0|0.8948|1.011|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||1.011|0.8948|
71777635|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|5.45||||0.0501|TWO_SIDED|95.0|0.0|10.91|||Cochran-Mantel-Haenszel|||Week 12, Day 84||10.91|-0.00|0.0501
71777636|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7||8.31|-8.31|1.0000
71777637|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14||8.31|-8.31|1.0000
71777638|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|2.05||||0.6564|TWO_SIDED|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28||11.11|-7.00|0.6564
71664509|NCT01635218|142842066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_ERROR_OF_MEAN|2.37||0.424|TWO_SIDED|95.0|-2.33|9.6||The ANOVA result (p\<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA|||||9.6|-2.33|0.424
71664510|NCT01635218|142842067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||0.1||95.0|0.05|1.32|||Chi-squared|||||1.32|0.05|0.10
71664511|NCT01635218|142842067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.11|TWO_SIDED|95.0|0.05|1.39|||Chi-squared|||||1.39|0.05|0.11
71664512|NCT03262038|142842080|SUPERIORITY|||||||0.412|||||||Chi-squared|||||||.412
71664513|NCT03262038|142842081|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||.633
71664514|NCT03262038|142842082|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||.007
71664515|NCT03262038|142842083|SUPERIORITY|||||||0.634|||||||Chi-squared|||||||.634
71743919|NCT04640311|142998523|OTHER||Geometric mean ratio|1.042|||||TWO_SIDED|90.0|0.9308|1.166|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 1 has been presented.|||1.166|0.9308|
71743920|NCT04640311|142998523|OTHER||Geometric mean ratio|1.048|||||TWO_SIDED|90.0|0.9349|1.175|||||Geometric mean ratio of Daprodustat Process 1 to Process 2 Dissolution Profile 2 has been presented.|||1.175|0.9349|
71743921|NCT04640311|142998524|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9716|||||TWO_SIDED|90.0|0.8936|1.056|||||Geometric mean ratio of Daprodustat 1 mg Process 2 to Process 1 has been presented.|||1.056|0.8936|
71777639|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.0||||1|TWO_SIDED|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56||8.31|-8.31|1.0000
71777640|NCT02833350|143054250|SUPERIORITY||Adjusted Difference|0.68||||0.9051|TWO_SIDED|95.0|-10.58|11.95|||Cochran-Mantel-Haenszel|||Week 12, Day 84||11.95|-10.58|0.9051
71777641|NCT02038881|143054312|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.851|||||TWO_SIDED|95.0|0.258|2.8||||||||2.800|0.258|
71777642|NCT02038881|143054312|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.653|||||TWO_SIDED|95.0|0.319|1.333||||||||1.333|0.319|
71777643|NCT02038881|143054312|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|1.126|||||TWO_SIDED|95.0|0.291|4.352||||||||4.352|0.291|
71777644|NCT02038881|143054312|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.916|||||TWO_SIDED|95.0|0.22|3.819||||||||3.819|0.220|
71777645|NCT02038881|143054312|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|1.045|||||TWO_SIDED|95.0|0.292|3.741||||||||3.741|0.292|
71834340|NCT02605837|143172500|SUPERIORITY||Difference in Least square mean|-1.8|||<|0.001||95.0|-2.6|-1.1|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline. Total EREFS (endoscopy score) as a continuous covariate.||-1.1|-2.6|<0.001
71834341|NCT02605837|143172501|SUPERIORITY||Odds Ratio (OR)|169.74|||<|0.001||95.0|23.235|1239.979|||Regression, Logistic|||Peak eosinophil count (\<15/HPF) was performed based on logistic regression model adjusted for age group and diet restriction.||1239.979|23.235|<0.001
71834342|NCT02605837|143172501|SUPERIORITY||Odds Ratio (OR)|100.69||||0.001|TWO_SIDED|95.0|6.294|1610.749|||Firth logistic regression|||Peak eosinophil count (\<=1/HPF) was performed based on firth logistic regression model adjusted for age group and diet restriction.||1610.749|6.294|0.001
71743922|NCT04640311|142998524|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9006|||||TWO_SIDED|90.0|0.8107|1.0|||||Geometric mean ratio of Daprodustat 2 mg Process 2 to Process 1 has been presented.|||1.000|0.8107|
71743923|NCT04640311|142998524|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9703|||||TWO_SIDED|90.0|0.8665|1.087|||||Geometric mean ratio of Daprodustat 4 mg Process 2 to Process 1 has been presented.|||1.087|0.8665|
71834343|NCT02605837|143172502|SUPERIORITY||Difference in Least square mean|-28.4|||<|0.001||95.0|-35.0|-21.8|||ANCOVA|||This analysis of proximal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-21.8|-35.0|<0.001
71834344|NCT02605837|143172502|SUPERIORITY||Difference in Least square mean|-30.4|||<|0.001||95.0|-38.1|-22.7|||ANCOVA|||This analysis of mid eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-22.7|-38.1|<0.001
71834345|NCT02605837|143172502|SUPERIORITY||Difference in Least square mean|-33.1|||<|0.001||95.0|-40.7|-25.5|||ANCOVA|||This analysis of distal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate||-25.5|-40.7|<0.001
71834346|NCT02605837|143172502|SUPERIORITY||Difference in LS Mean|-47.6|||<|0.001|TWO_SIDED|95.0|-56.4|-38.8|||ANCOVA|||This analysis of maximum eosinophil count was from the ANCOVA model with treatment group and age group as factors and the baseline Peak eosinophil count as a continuous covariate.||-38.8|-56.4|<0.001
71743924|NCT04640311|142998524|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.9675|||||TWO_SIDED|90.0|0.8778|1.066|||||Geometric mean ratio of Daprodustat 6 mg Process 2 to Process 1 has been presented.|||1.066|0.8778|
71743925|NCT04640311|142998524|EQUIVALENCE|Bioequivalence was to be determined if the 90% CI of ratio's of geometric means (geometric mean of Process 2/Process 1) falls within a range of 0.80 to 1.25.|Geometric mean ratio|0.8606|||||TWO_SIDED|90.0|0.777|0.9532|||||Geometric mean ratio of Daprodustat 8 mg Process 2 to Process 1 has been presented.|||0.9532|0.7770|
71743926|NCT02707146|142998549|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|||||Chi-squared|||||||
71890925|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.32||||0.3811|TWO_SIDED|95.0|-20.64|8.0|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.00|-20.64|0.3811
71743927|NCT01284517|142998566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.08||0.176|||||||Mixed Models Analysis|||Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.||||0.176
71743928|NCT01284517|142998567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.141||0.095|||||||Mixed Models Analysis|||||||0.095
71743929|NCT01284517|142998568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.992|||||||ANCOVA|||||||0.992
71834347|NCT02605837|143172503|SUPERIORITY||Difference in Least square mean|-0.19|||<|0.001||95.0|-0.22|-0.16|||ANCOVA|||This analysis of histopathologic epithelial features combined grade TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.16|-0.22|<0.001
71834348|NCT02605837|143172503|SUPERIORITY||Difference in Least square mean|-0.2|||<|0.001||95.0|-0.2|-0.2|||ANCOVA|||This analysis of histopathologic epithelial features combined stage TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.||-0.2|-0.2|<0.001
71834349|NCT02605837|143172504|SUPERIORITY||Odds Ratio (OR)|1.42||||0.164|TWO_SIDED|95.0|0.866|2.333|||Regression, Logistic|||Dysphagia symptom response (binary response) at the final treatment period was performed based on logistic regression model adjusted for age group and diet restriction.||2.333|0.866|0.164
71834350|NCT02605837|143172505|SUPERIORITY||Odds Ratio (OR)|91.86||||0.001|TWO_SIDED|95.0|5.687|1483.68|||Firth logistic regression|||Overall binary response I at the final treatment period was performed based on firth logistic regression model adjusted for age group and diet restriction.||1483.680|5.687|0.001
71834351|NCT02605837|143172506|SUPERIORITY||Odds Ratio (OR)|61.68||||0.004|TWO_SIDED|95.0|3.836|991.858|||Firth logistic regression|||Overall binary response II at the final treatment period was perfomed based on based on firth logistic regression model adjusted for age group and diet restriction.||991.858|3.836|0.004
71834352|NCT02605837|143172507|SUPERIORITY||Difference in Least square mean|-6.41||||0.004||95.0|-10.757|-2.063|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ + Pain score as a continuous covariate.||-2.063|-10.757|0.004
71834353|NCT02605837|143172508|SUPERIORITY||Difference in Least square mean|-2.46||||0.002||95.0|-4.018|-0.909|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ Pain score as a continuous covariate.||-0.909|-4.018|0.002
71664516|NCT00094861|142842088|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.8553||||0.355||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 2 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3550
71664517|NCT00094861|142842089|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9936||||0.3189||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.3189
71743930|NCT00040443|142998569|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.05
71743931|NCT01588561|142998587|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum|||
71743932|NCT01588561|142998588|OTHER||||||||||||||||||Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum|||
71743933|NCT01588561|142998589|OTHER||||||||||||||||||Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal\&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum|||
71743934|NCT01818596|142998594|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|98.94|||||TWO_SIDED|90.0|93.71|104.46|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI). Postbaseline value and baseline value were used as test and reference, respectively.||104.46|93.71|
71743935|NCT01818596|142998594|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is \< 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|102.66|||||TWO_SIDED|90.0|97.11|108.53|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI. Week 24 value and baseline value were used as test and reference, respectively.||108.53|97.11|
71743936|NCT03801174|142998612|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.92||0.804|TWO_SIDED|95.0|-2.0|1.6|||Mixed Models Analysis|||||1.6|-2.0|.804
71777646|NCT02038881|143054312|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.315|||||TWO_SIDED|95.0|0.598|2.892||||||||2.892|0.598|
71777647|NCT02038881|143054313|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.762|||||TWO_SIDED|95.0|0.385|1.507||||||||1.507|0.385|
71777648|NCT02038881|143054314|OTHER||GMT Ratio (Group 1 [W6]/ Group 3 [W14)|0.347|||||TWO_SIDED|95.0|0.2|0.603||||||||0.603|0.200|
71777649|NCT02038881|143054314|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.532|||||TWO_SIDED|95.0|0.285|0.992||||||||0.992|0.285|
71664518|NCT00094861|142842090|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.437||||0.5086||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade 5 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.5086
71664519|NCT00094861|142842091|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.46||||0.4976||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 3 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.4976
71664520|NCT00094861|142842092|SUPERIORITY_OR_OTHER||Chi-Square Statistic|-2.5325||||0.1115||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants who never received radiotherapy were assumed to have unplanned breaks.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1115
71743937|NCT03801174|142998613|SUPERIORITY||Mean Difference (Net)|50.2|STANDARD_ERROR_OF_MEAN|93.0||0.59|TWO_SIDED|95.0|-132.0|233.0|||Mixed Models Analysis|||||233|-132|.590
71743938|NCT03801174|142998614|SUPERIORITY||Mean Difference (Net)|806.0|STANDARD_ERROR_OF_MEAN|443.0||0.069|TWO_SIDED|95.0|-64.0|1675.0|||Mixed Models Analysis|||||1675|-64|.069
71777650|NCT02038881|143054315|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|4.138|||||TWO_SIDED|95.0|1.241|13.793||||||||13.793|1.241|
71777651|NCT02038881|143054315|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|4.608|||||TWO_SIDED|95.0|1.365|15.558||||||||15.558|1.365|
71777652|NCT02038881|143054315|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.215|||||TWO_SIDED|95.0|0.066|0.699||||||||0.699|0.066|
71777653|NCT02038881|143054315|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.237|||||TWO_SIDED|95.0|0.072|0.782||||||||0.782|0.072|
71777654|NCT02038881|143054316|OTHER||GMT Ratio (Group 1 / Group 2) at Week 4|0.823|||||TWO_SIDED|95.0|0.333|2.038||||||||2.038|0.333|
71777655|NCT02038881|143054316|OTHER||GMT Ratio (Group 1 / Group 2) at Week 6|0.787|||||TWO_SIDED|95.0|0.41|1.508||||||||1.508|0.410|
71777656|NCT02038881|143054316|OTHER||GMT Ratio (Group 1 / Group 2) at Week 30|0.535|||||TWO_SIDED|95.0|0.187|1.536||||||||1.536|0.187|
71743939|NCT01337336|142998628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.002||95.0|1.08|1.56|||Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.56|1.08|0.002
71743940|NCT01337336|142998629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.002||95.0|1.02|2.38||COPD-related hospitalization|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.38|1.02|0.002
71743941|NCT01337336|142998629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002||95.0|1.14|2.39||COPD-related ER visit|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.39|1.14|0.002
71743942|NCT01337336|142998629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.503||95.0|0.93|1.4|||Chi-squared|COPD-related physician + Rx visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.40|0.93|0.503
71743943|NCT01337336|142998629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71|||<|0.001||95.0|1.26|2.31|||Chi-squared|COPD-related hospitalization/ER visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.31|1.26|<0.001
71743944|NCT01337336|142998631|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.46||||0.0004||95.0|1.01|2.09||COPD-related hospitalization|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||2.09|1.01|0.0004
71743945|NCT01337336|142998631|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.27||||0.208||95.0|0.89|1.82||COPD-related ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.82|0.89|0.208
71743946|NCT01337336|142998631|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.09||||0.671||95.0|0.9|1.32||COPD-related physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.32|0.90|0.671
71743947|NCT01337336|142998631|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.31||||0.009||95.0|1.05|1.72||COPD-related hospitalization/ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.72|1.05|0.009
71743948|NCT01337336|142998631|SUPERIORITY_OR_OTHER||Incident Rate Ratio|1.16||||0.052||95.0|0.98|1.37||COPD-related hospitalization/ER visit/physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.|||1.37|0.98|0.052
71777657|NCT02038881|143054316|OTHER||GMT Ratio (Group 1 / Group 2) at Week 56|0.59|||||TWO_SIDED|95.0|0.203|1.716||||||||1.716|0.203|
71777658|NCT02038881|143054316|OTHER||GMT Ratio (Group 3 / Group 1) at Week 4|2.557|||||TWO_SIDED|95.0|0.972|6.731||||||||6.731|0.972|
71777659|NCT02038881|143054316|OTHER||GMT Ratio (Group 3 / Group 1) at Week 6|1.215|||||TWO_SIDED|95.0|0.612|2.412||||||||2.412|0.612|
71777660|NCT02038881|143054317|OTHER||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.878|||||TWO_SIDED|95.0|0.48|1.606||||||||1.606|0.480|
71777661|NCT02038881|143054318|OTHER||GMT ratio (Group 1 [W6]/ Group 3 [W14)|0.281|||||TWO_SIDED|95.0|0.146|0.542||||||||0.542|0.146|
71777662|NCT02038881|143054318|OTHER||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.357|||||TWO_SIDED|95.0|0.178|0.718||||||||0.718|0.178|
71777663|NCT02038881|143054319|OTHER||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|6.727|||||TWO_SIDED|95.0|2.493|18.15||||||||18.150|2.493|
71777664|NCT02038881|143054319|OTHER||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|7.275|||||TWO_SIDED|95.0|2.693|19.649||||||||19.649|2.693|
71743949|NCT02501590|142998637|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71743950|NCT01695135|142998646|SUPERIORITY||Hazard Ratio (HR)|0.528||||0.0002|TWO_SIDED|95.0|0.376|0.74|||Log Rank|||||0.740|0.376|0.0002
71743951|NCT02714569|142998667|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Square Means Percentage|204.8|||||TWO_SIDED|90.0|161.9|259.0|||||Analysis was the estimate of the ratio fasted versus fed.|Geometric Mean Fed/Fasted Ratio of LY3202328 Cmax at 30 mg||259.0|161.9|
71743952|NCT02714569|142998669|NON_INFERIORITY|Analyses were based on a pre-defined non-inferiority margin|Least Squares Mean Percentage|193.3|||||TWO_SIDED|90.0|144.7|258.2||||||Geometric Mean Fed/Fasted Ratio of LY3202328 AUC(0-inf) at 30 mg||258.2|144.7|
71743953|NCT02714569|142998681|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|141.0|||||TWO_SIDED|90.0|67.9|293.0||||||Part B Placebo||293.0|67.9|
71743954|NCT02714569|142998681|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|70.8|||||TWO_SIDED|90.0|31.9|157.1||||||Part B 5 mg LY||157.1|31.9|
71777665|NCT02038881|143054319|OTHER||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.278|||||TWO_SIDED|95.0|0.115|0.672||||||||0.672|0.115|
71777666|NCT02038881|143054319|OTHER||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.233|||||TWO_SIDED|95.0|0.1|0.541||||||||0.541|0.100|
71777667|NCT02038881|143054320|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-7.6|||||TWO_SIDED|95.0|-34.1|17.9||||||||17.9|-34.1|
71777668|NCT02038881|143054320|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
71777669|NCT02038881|143054320|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|5.1|||||TWO_SIDED|95.0|-24.5|32.6||||||||32.6|-24.5|
71777670|NCT02038881|143054320|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-1.5|||||TWO_SIDED|95.0|-31.5|29.2||||||||29.2|-31.5|
71777671|NCT02038881|143054320|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|-5.8|||||TWO_SIDED|95.0|-32.8|22.2||||||||22.2|-32.8|
71777672|NCT02038881|143054320|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-7.7|||||TWO_SIDED|95.0|-25.1|10.1||||||||10.1|-25.1|
71777673|NCT02038881|143054321|OTHER||Difference in seroconversion rates (%)|-4.3|||||TWO_SIDED|95.0|-15.2|11.6||||||||11.6|-15.2|
71743955|NCT02714569|142998681|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|109.2|||||TWO_SIDED|90.0|99.8|119.5||||||Part B 20 mg LY||119.5|99.8|
71834354|NCT05656911|143172567|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-5.0|||||TWO_SIDED|95.0|-29.0|18.0|||||Posterior probability is 34.0%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||18.0|-29.0|
71834355|NCT05656911|143172568|OTHER||Mean Difference (Final Values)|11.31||||0.257|TWO_SIDED|95.0|-8.26|30.87||two-sided. No adjustment for multiple comparisons.|ANCOVA||LS mean (%)|The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||30.87|-8.26|0.257
71834356|NCT05656911|143172569|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-27.0|22.1|||||Posterior probability is 41.7%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||22.1|-27.0|
71743956|NCT02714569|142998681|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|107.7|||||TWO_SIDED|90.0|68.1|170.4||||||Part B 100 mg LY||170.4|68.1|
71743957|NCT02714569|142998681|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|213.3|||||TWO_SIDED|90.0|200.3|227.1||||||Part B 300 mg LY||227.1|200.3|
71743958|NCT02714569|142998681|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|115.4|||||TWO_SIDED|90.0|91.2|146.2||||||Part B Overall||146.2|91.2|
71743959|NCT02714569|142998682|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|155.0|||||TWO_SIDED|90.0|87.6|274.2||||||Part B Placebo||274.2|87.6|
71743960|NCT02714569|142998682|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|71.5|||||TWO_SIDED|90.0|40.7|125.3||||||Part B 5 mg LY||125.3|40.7|
71743961|NCT02714569|142998682|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratios (%)|122.4|||||TWO_SIDED|90.0|90.7|165.1||||||Part B 20 mg LY||165.1|90.7|
71743962|NCT02714569|142998682|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|136.6|||||TWO_SIDED|90.0|89.8|207.7||||||Part B 100 mg LY||207.7|89.8|
71743963|NCT02714569|142998682|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|132.6|||||TWO_SIDED|90.0|90.5|194.4||||||Part B 300 mg LY||194.4|90.5|
71743964|NCT02714569|142998682|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|112.2|||||TWO_SIDED|90.0|93.2|135.1||||||Part B Overall||135.1|93.2|
71743965|NCT02714569|142998683|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|97.3|||||TWO_SIDED|90.0|80.4|117.8||||||Part B Placebo||117.8|80.4|
71743966|NCT02714569|142998683|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|57.5|||||TWO_SIDED|90.0|31.3|106.0||||||||106.0|31.3|
71743967|NCT02714569|142998683|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|96.2|||||TWO_SIDED|90.0|66.8|138.7||||||Part B 20 mg LY||138.7|66.8|
71743968|NCT02714569|142998683|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|80.9|||||TWO_SIDED|90.0|45.8|142.7||||||Part B 100 mg LY||142.7|45.8|
71743969|NCT02714569|142998683|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|108.2|||||TWO_SIDED|90.0|40.2|291.2||||||Part B 300 mg LY||291.2|40.2|
71743970|NCT02714569|142998683|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|87.9|||||TWO_SIDED|90.0|67.4|114.7||||||Part B Overall||114.7|67.4|
71743971|NCT02714569|142998684|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|96.0|||||TWO_SIDED|90.0|90.2|102.1||||||Part B Placebo||102.1|90.2|
71743972|NCT02714569|142998684|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|90.7|||||TWO_SIDED|90.0|59.8|137.6||||||Part B 5 mg LY||137.6|59.8|
71743973|NCT02714569|142998684|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|99.9|||||TWO_SIDED|90.0|75.9|131.5||||||Part B 20 mg LY||131.5|75.9|
71743974|NCT02714569|142998684|OTHER|Ratio estimate without hypothesis testing|Geometric Least Square Means Ratio (%)|91.0|||||TWO_SIDED|90.0|67.5|122.7||||||Part B 100 mg LY||122.7|67.5|
71743975|NCT02714569|142998684|OTHER|Ratio estimate without hypothesis testing|Geometric Least Squares Mean Ratio (%)|87.0|||||TWO_SIDED|90.0|42.0|180.5||||||Part B 300 mg LY||180.5|42.0|
71743976|NCT02714569|142998684|OTHER|Ratio estimate without hypothesis|Geometric Least Squares Mean Ratio (%)|93.5|||||TWO_SIDED|90.0|81.8|106.9||||||Part B Overall||106.9|81.8|
71743977|NCT04915729|142998685|NON_INFERIORITY|pre-specified non-inferiority margin for risk ratio = 0.937|Risk Ratio (RR)|1.0278|||||TWO_SIDED|95.0|0.9678|1.0915|||Modified Possion Regression Model|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0915|0.9678|
71834357|NCT05656911|143172570|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-4.6|||||TWO_SIDED|95.0|-25.6|13.4|||||Posterior probability is 31.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||13.4|-25.6|
71834358|NCT05656911|143172571|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-12.5|||||TWO_SIDED|95.0|-34.1|7.0|||||Posterior probability is 10.8%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||7.0|-34.1|
71777674|NCT02038881|143054322|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
71777675|NCT02038881|143054322|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
71743978|NCT04915729|142998686|OTHER|log-binomial regression model|Risk Ratio (RR)|1.0671||||0.2412|TWO_SIDED|95.0|0.9573|1.1895||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.1895|0.9573|0.2412
71743979|NCT04915729|142998687|OTHER|Modified Poisson regression model|Risk Ratio (RR)|1.0078||||0.748|TWO_SIDED|95.0|0.9614|1.0564||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.0564|0.9614|0.7480
71743980|NCT04915729|142998688|OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.48||0.3511|TWO_SIDED|95.0|-1.4|0.5|||Mixed Models Analysis|baseline NIHSS, age, time to administration since stroke symptoms onset = linear covariates; treatment = fixed effects|Difference in LSmean tenecteplase vs alteplase|||0.50|-1.40|0.3511
71777676|NCT02038881|143054323|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|5.6|||||TWO_SIDED|95.0|-19.6|33.0||||||||33.0|-19.6|
71777677|NCT02038881|143054323|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|16.7|||||TWO_SIDED|95.0|-11.0|44.4||||||||44.4|-11.0|
71777678|NCT02038881|143054323|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-10.6|||||TWO_SIDED|95.0|-35.6|14.3||||||||14.3|-35.6|
71777679|NCT02038881|143054323|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-15.2|||||TWO_SIDED|95.0|-40.5|10.5||||||||10.5|-40.5|
71777680|NCT02038881|143054324|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-9.6|||||TWO_SIDED|95.0|-38.4|20.3||||||||20.3|-38.4|
71777681|NCT02038881|143054324|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||TWO_SIDED|95.0|-16.8|16.3||||||||16.3|-16.8|
71777682|NCT02038881|143054324|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 30|-9.6|||||TWO_SIDED|95.0|-38.4|17.6||||||||17.6|-38.4|
71777683|NCT02038881|143054324|OTHER||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-6.1|||||TWO_SIDED|95.0|-35.6|23.7||||||||23.7|-35.6|
71777684|NCT02038881|143054324|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 4|20.8|||||TWO_SIDED|95.0|-7.7|47.8||||||||47.8|-7.7|
71777685|NCT02038881|143054324|OTHER||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-3.8|||||TWO_SIDED|95.0|-20.5|13.4||||||||13.4|-20.5|
71777686|NCT02038881|143054325|OTHER||Difference in seroconversion rates (%)|-2.2|||||TWO_SIDED|95.0|-12.0|13.2||||||||13.2|-12.0|
71777687|NCT02038881|143054326|OTHER||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-17.1|13.4||||||||13.4|-17.1|
71777688|NCT02038881|143054326|OTHER||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||TWO_SIDED|95.0|-16.2|13.4||||||||13.4|-16.2|
71777689|NCT02038881|143054327|OTHER||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|19.4|||||TWO_SIDED|95.0|-4.5|45.8||||||||45.8|-4.5|
71777690|NCT02038881|143054327|OTHER||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|29.2|||||TWO_SIDED|95.0|5.8|55.4||||||||55.4|5.8|
71743981|NCT04915729|142998689|OTHER||Odds Ratio (OR)|1.0418||||0.4806|||||||Regression, Logistic|Assumption-free ordinal analysis|tenecteplase versus alteplase|||||0.4806
71743982|NCT04915729|142998690|OTHER|Poisson regression model|Risk Ratio (RR)|1.0189||||0.5116|TWO_SIDED|95.0|0.9635|1.0774|||Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = covariates|tenecteplase versus alteplase|||1.0774|0.9635|0.5116
71743983|NCT04915729|142998691|OTHER||Risk Ratio (RR)|1.005||||1|TWO_SIDED|95.0|0.37|2.701|||Suissa-Shuster test||tenecteplase versus alteplase|||2.701|0.370|1.000
71743984|NCT04915729|142998692|OTHER||Risk Ratio (RR)|0.795||||0.303|TWO_SIDED|95.0|0.513|1.232|||Chi-squared||tenecteplase versus alteplase|||1.232|0.513|0.303
71743985|NCT04915729|142998693|OTHER|Modified Poisson regression model|Risk Ratio (RR)|0.9215||||0.6345|TWO_SIDED|95.0|0.6578|1.2908||p-value was for superiority testing|Regression, Linear|treatment = main effect; baseline NHISS, age + time to drug administration since stroke symptoms onset = continuous covariates|tenecteplase versus alteplase|||1.2908|0.6578|0.6345
71743986|NCT00587678|142998695|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Linear repeated measures model|||||||0.32
71777691|NCT02038881|143054327|OTHER||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-9.8|||||TWO_SIDED|95.0|-33.0|11.7||||||||11.7|-33.0|
71777692|NCT02038881|143054327|OTHER||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-23.1|||||TWO_SIDED|95.0|-46.7|-1.0||||||||-1.0|-46.7|
71777693|NCT00178633|143054347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
71777694|NCT01254292|143054365|SUPERIORITY_OR_OTHER||single proportion|82.1|||||TWO_SIDED|95.0|77.1|86.5|||||Clopper Pearson Confidence Interval|||86.5|77.1|
71777695|NCT01254292|143054365|SUPERIORITY_OR_OTHER||single proportion|81.9|||||TWO_SIDED|95.0|76.7|86.4|||||Clopper Pearson Confidence Interval|||86.4|76.7|
71777696|NCT03800173|143054406|OTHER||Slope|0.982|||||TWO_SIDED|90.0|0.868|1.096||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed Cmax. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.096|0.868|
71777697|NCT03800173|143054407|OTHER||Slope|1.0|||||TWO_SIDED|90.0|0.872|1.128||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-inf Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1||1.128|0.872|
71777698|NCT03800173|143054407|OTHER||Slope|1.086|||||TWO_SIDED|90.0|0.952|1.219||||||A model with In-transformed dose (dose continuous) as a fixed effect \& subject as a random effect was applied to In-transformed AUC0-t. Dose proportionality was assessed by restricted max likelihood using SAS PROC MIXED. The mean slope was estimated from the power model \& the corresponding 90% CI calculated. Although there was no formal statistical hypothesis tested for this secondary objective, there was evidence for dose proportionality if the 90% CI of the fixed slope for In-dose contained 1.||1.219|0.952|
71743987|NCT00587678|142998695|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||vs. baseline|Linear repeated measures model|||||||<0.01
71743988|NCT00587678|142998696|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Linear repeated measures model|||||||0.31
71743989|NCT00587678|142998696|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
71743990|NCT00587678|142998697|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Linear repeated measures model|||||||0.71
71743991|NCT00587678|142998698|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Linear repeated measures model|||||||0.67
71743992|NCT00587678|142998699|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Linear repeated measures model|||||||0.37
71743993|NCT00587678|142998699|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||vs. baseline|Linear repeated measures model|||||||<0.05
71743994|NCT00587678|142998700|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Linear repeated measures model|||||||0.78
71834359|NCT05656911|143172572|OTHER||Mean Difference (Final Values)|7.06||||0.166|TWO_SIDED|95.0|-2.92|17.03||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||17.03|-2.92|0.166
71834360|NCT05656911|143172573|OTHER|Bayesian analysis according to estimand|Mean Difference (Final Values)|-8.4|||||TWO_SIDED|95.0|-30.4|11.0|||||Posterior probability is 20.5%|Median of posterior distribution of difference between Zabedosertib and Placebo including credible interval. Posterior probability is presented that the responder rate after treatment with zabedosertib is higher than after placebo given the data observed in the study.||11.0|-30.4|
71743995|NCT00587678|142998701|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Linear repeated measures model|||||||0.68
71777699|NCT00910273|143054422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.608|TWO_SIDED|95.0|-5.14|8.58|||Mixed Models Analysis|||"Null Hypothesis: No difference in Change in FMD at 12 weeks for Etanercept and placebo.~Alternative Hypothesis: Difference in Change in FMD at 12 weeks for Etanercept and placebo.~Sample size of 36 subjects per treatment arm was planned based on an expected difference of 0.9 in FMD (Standard Deviation \[SD\] 1.5), with 80% power and 5% significance level."||8.58|-5.14|0.608
71777700|NCT00910273|143054423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.82||||0.476|TWO_SIDED|95.0|-3.35|7.0|||Mixed Models Analysis||Analyses available for Week 4 only, due to limited number of participants for Week 24 to Week 52.|Week 4||7.00|-3.35|0.476
71743996|NCT00587678|142998702|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Linear repeated measures model|||||||<0.05
71743997|NCT00587678|142998703|SUPERIORITY_OR_OTHER||||||=|0.67||95.0|||||linear repeated measures model|||||||=0.67
71743998|NCT00587678|142998704|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Linear repeated measures model|||||||0.77
71743999|NCT00587678|142998705|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Linear repeated measures model|||||||0.85
71777701|NCT00910273|143054424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.65|TWO_SIDED|95.0|-0.08|0.13|||ANCOVA|||Week 12; Common Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.13|-0.08|0.650
71744000|NCT05282927|142998706|SUPERIORITY||Mean Difference (Net)|-0.05||||0.92|TWO_SIDED|95.0|-1.07|0.98|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans)||0.98|-1.07|0.92
71744001|NCT05282927|142998707|SUPERIORITY||Mean Difference (Net)|0.94||||0.056|TWO_SIDED|95.0|-0.03|1.9|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization: site complexity level (high complexity '1a', '1b' or '1c' vs. all others) and rurality (high sites serving ≥50% rural/highly rural Veterans vs. low sites serving \<50% rural/highly rural Veterans).||1.90|-0.03|0.056
71744002|NCT02294058|142998726|SUPERIORITY||Rate Ratio|0.518|||<|0.0001|TWO_SIDED|95.0|0.405|0.663||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, Baseline age, number of gadolinium enhancing (GdE) lesions and included the natural log transformation of time as an offset term.||||0.663|0.405|<0.0001
71834361|NCT05656911|143172575|OTHER||Mean Difference (Final Values)|6.68||||0.396|TWO_SIDED|95.0|-8.75|22.11||two-sided. No adjustment for multiple comparisons.|ANCOVA|||The analysis of covariance (ANCOVA) model includes treatment group as fixed effect and the EASI baseline value as covariate.||22.11|-8.75|0.396
71744003|NCT02294058|142998726|SUPERIORITY||Rate Ratio|0.688||||0.0013|TWO_SIDED|95.0|0.547|0.864||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, Baseline age and the number of GdE lesions, and included the natural log transformation of time on study as an offset term.||||0.864|0.547|0.0013
71744004|NCT02294058|142998727|SUPERIORITY||Rate Ratio|0.517|||<|0.0001|TWO_SIDED|95.0|0.427|0.625||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.625|0.427|<0.0001
71744005|NCT02294058|142998727|SUPERIORITY||Rate Ratio|0.754||||0.0032|TWO_SIDED|95.0|0.625|0.91||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.910|0.625|0.0032
71744006|NCT02294058|142998728|SUPERIORITY||Rate Ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.256|0.536||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.536|0.256|<0.0001
71834362|NCT03088813|143172579|OTHER||Hazard Ratio (HR)|1.11||||0.3094|TWO_SIDED|95.0|0.9|1.37|||Stratified log-rank test|From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity.|The associated HR and two-sided 95% Confidence Interval (CI) were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.37|0.90|0.3094
71777702|NCT00910273|143054424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.513|TWO_SIDED|95.0|-0.13|0.07|||ANCOVA|||Week 12; Common Bulb; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.07|-0.13|0.513
71777703|NCT00910273|143054424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.592|TWO_SIDED|95.0|-0.14|0.08|||ANCOVA|||Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12||0.08|-0.14|0.592
71777704|NCT00910273|143054429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77||||0.008|TWO_SIDED|95.0|-3.05|-0.5|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.50|-3.05|0.008
71834363|NCT03088813|143172583|OTHER||Hazard Ratio (HR)|0.96||||0.7053|TWO_SIDED|95.0|0.77|1.2||From stratified log-rank test, stratified by corrected region and corrected platinum sensitivity|Stratified log-rank test||The associated HR and two-sided 95% CI were estimated using stratified Cox proportional hazards model, stratified by corrected region and corrected platinum sensitivity.|||1.20|0.77|0.7053
71744007|NCT02294058|142998728|SUPERIORITY||Rate Ratio|0.662||||0.0182|TWO_SIDED|95.0|0.471|0.932||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.||||0.932|0.471|0.0182
71744008|NCT02294058|142998729|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.3055|TWO_SIDED|95.0|0.34|1.402|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age, and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.402|0.340|0.3055
71744009|NCT02294058|142998729|SUPERIORITY||Hazard Ratio (HR)|0.886||||0.7163|TWO_SIDED|95.0|0.46|1.705|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||1.705|0.460|0.7163
71744010|NCT02294058|142998730|SUPERIORITY||Hazard Ratio (HR)|1.238||||0.6725|TWO_SIDED|95.0|0.46|3.337|||Cox proportional hazards model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.337|0.460|0.6725
71744011|NCT02294058|142998730|SUPERIORITY||Hazard Ratio (HR)|1.535||||0.3755|TWO_SIDED|95.0|0.595|3.963|||Cox proportional hazard model|Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score|Hazard Ratio (Ozanimod / IFN β-1a)|||3.963|0.595|0.3755
71744012|NCT02294058|142998731|SUPERIORITY||Difference in Percentages|10.88||||0.0006|TWO_SIDED|95.0|4.84|16.92|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per Interactive Voice Response System (IVRS)||||16.92|4.84|0.0006
71744013|NCT02294058|142998731|SUPERIORITY||Difference in Percentages|5.12||||0.113|TWO_SIDED|95.0|-1.07|11.32|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS category per IVRS.||||11.32|-1.07|0.1130
71744014|NCT02294058|142998732|SUPERIORITY||Difference in Percentages|4.53||||0.118|TWO_SIDED|95.0|-1.19|10.24|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||10.24|-1.19|0.1180
71744015|NCT02294058|142998732|SUPERIORITY||Difference in percentages|2.95||||0.3023|TWO_SIDED|95.0|-2.7|8.6|||Cochran-Mantel-Haenszel|Based on the CMH test stratified by region and EDSS Scale category per IVRS.||||8.60|-2.70|0.3023
71744016|NCT02294058|142998733|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and EDSS category per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||<0.0001
71744017|NCT02294058|142998733|SUPERIORITY|||||||0.0615|||||||Rank ANCOVA|Adjusted for region and EDSS Scale per IVRS||Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.||||0.0615
71744018|NCT02294058|142998734|SUPERIORITY||LS Mean Difference|0.034||||0.129|TWO_SIDED|95.0|-0.01|0.077|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score.||||0.077|-0.010|0.1290
71744019|NCT02294058|142998734|SUPERIORITY||LS Mean Difference|0.015||||0.4942|TWO_SIDED|95.0|-0.028|0.059|||ANCOVA|Adjusted for region, EDSS category per IVRS and the Baseline MSFC score||||0.059|-0.028|0.4942
71744020|NCT02294058|142998735|SUPERIORITY||Mean Difference (Final Values)|1.642||||0.0364|TWO_SIDED|95.0|0.104|3.18|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||3.180|0.104|0.0364
71744021|NCT02294058|142998735|SUPERIORITY||Mean Difference (Final Values)|1.024||||0.1905|TWO_SIDED|95.0|-0.51|2.559|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Physical Health Composite Summary||2.559|-0.510|0.1905
71744022|NCT02294058|142998735|SUPERIORITY||Mean Difference (Final Values)|0.356||||0.7104|TWO_SIDED|95.0|-1.523|2.234|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||2.234|-1.523|0.7104
71744023|NCT02294058|142998735|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.8587|TWO_SIDED|95.0|-2.045|1.705|||ANCOVA|Adjusted for region, EDSS category per IVRS, and the Baseline summary score.||Analysis of Mental Health Composite Summary||1.705|-2.045|0.8587
71744024|NCT01332994|142998836|SUPERIORITY_OR_OTHER|||||||0.1648|TWO_SIDED|||||Exact one-sided binomial test on single proportions with a significance level of alpha equals (=) 0.025. Null hypothesis: Proportion of participants reaching DAS28 remission (\<2.6) at Week 16 is ≤45 percent (%).|Exact one-sided binomial test|||||||0.1648
71777705|NCT00910273|143054429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.021|TWO_SIDED|95.0|-3.7|-0.33|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.33|-3.70|0.021
71834364|NCT03088813|143172584|OTHER||Difference in ORR|22.29|||<|0.0001|TWO_SIDED|95.0|13.97|30.61||ORR difference, 95% CI and P-value are obtained from the Cochran-Mantel-Haenszel test stratified by corrected region and corrected platinum sensitivity.|Cochran-Mantel-Haenszel|||||30.61|13.97|<0.0001
71744025|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.7559|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cell compartment||||0.7559
71744026|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.8961|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Transitional B-cells||||0.8961
71744027|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.7915|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Naive B-cells||||0.7915
71744028|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.8081|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Memory B-cells||||0.8081
71744029|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.6574|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Pre-switch memory B-cells||||0.6574
71744030|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.4553|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Post-switch memory B-cells||||0.4553
71744031|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.2215|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgG-positive class-switched B-cells||||0.2215
71744032|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||IgA-positive class-switched B-cells||||0.8860
71744033|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.8693|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Double-negative B-cells||||0.8693
71744034|NCT01332994|142998872|SUPERIORITY_OR_OTHER|||||||0.9564|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Plasmablasts||||0.9564
71744035|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.9993|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.9993
71777706|NCT00910273|143054437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.003|TWO_SIDED|95.0|-1.74|-0.4|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.40|-1.74|0.003
71777707|NCT00910273|143054437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.029|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.10|-1.72|0.029
71777708|NCT00910273|143054443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.041|TWO_SIDED|95.0|-2.13|-0.05|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||-0.05|-2.13|0.041
71777709|NCT00910273|143054443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|95.0|-2.55|-0.01|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||-0.01|-2.55|0.048
71777710|NCT00910273|143054444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.575|TWO_SIDED|95.0|-0.89|1.57|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4||1.57|-0.89|0.575
71777711|NCT00910273|143054444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.204|TWO_SIDED|95.0|-0.52|2.3|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12||2.30|-0.52|0.204
71777712|NCT03841448|143054445|SUPERIORITY||Placebo-adjusted GM Percent Change|-37.367||||0.1032|TWO_SIDED|90.0|-60.951|0.46|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||0.460|-60.951|0.1032
71777713|NCT03841448|143054446|SUPERIORITY||Placebo-adjusted GM Percent Change|-36.167||||0.1432|TWO_SIDED|90.0|-61.552|5.978|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS mean difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||5.978|-61.552|0.1432
71777714|NCT03841448|143054447|SUPERIORITY||Odds Ratio (OR)|3.01||||0.1177|TWO_SIDED|90.0|0.43|21.27|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||21.27|0.43|0.1177
71777715|NCT03841448|143054447|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
71777716|NCT03841448|143054448|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1533|TWO_SIDED|90.0|0.45|20.34|||Cochran-Mantel-Haenszel|p-value was based on Cochran-Mantel-Haenszel test stratified by baseline 24-hour UP (≥1.0 g and \<2 g/day versus ≥2.0 g/day).|Odds ratio was estimated with logit method using a correction of 0.5 in every cell of the 2x2 table that contains a zero.|||20.34|0.45|0.1533
71777717|NCT03841448|143054448|SUPERIORITY||Difference in Proportions|0.23|||||TWO_SIDED|90.0|-0.13|0.42|||||Difference in proportions (cemdisiran - placebo) (90% CI) was based on the Wilson score method with continuity correction.|||0.42|-0.13|
71890926|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.36||||0.5044||95.0|-17.35|8.63|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.63|-17.35|0.5044
71664521|NCT00094861|142842093|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.4812||||0.0621|TWO_SIDED|||||Generalized Cochran-Mantel-Haenszel (CMH) test for mean score difference using modified ridit score. Participants without any ECOG assessment post baseline were assumed to have ECOG status of 5 in the CMH test.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.0621
71744036|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.3596|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.3596
71744037|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.7435|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.7435
71744038|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.7671|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.7671
71744039|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.7912|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.7912
71744040|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.5595|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.5595
71744041|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.3817|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.3817
71744042|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.3623|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.3623
71744043|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.7108|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7108
71744044|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.0639|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.0639
71744045|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.0186|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cell compartment||||0.0186
71777718|NCT03841448|143054449|SUPERIORITY||Placebo-adjusted GM Percent Change|-45.771||||0.0021|TWO_SIDED|90.0|-60.093|-26.309|||MMRM||Placebo-adjusted GM percent change, 90% CIs were calculated by exponentially back-transforming the model based LS means difference (cemdisiran - placebo) and the corresponding 90% CI then subtracting by 1.|||-26.309|-60.093|0.0021
71777719|NCT03181893|143054458|OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.183|<|0.0001|TWO_SIDED|90.0|-20.26|-9.37|||LANCOVA-P model|||||-9.37|-20.26|<0.0001
71744046|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Transitional B-cells||||0.0050
71744047|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.0463|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Naive B-cells||||0.0463
71744048|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.1919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Memory B-cells||||0.1919
71744049|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.3071|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Pre-switch memory B-cells||||0.3071
71744050|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.1714|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Post-switch memory B-cells||||0.1714
71744051|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.1746|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgG-positive class-switched B-cells||||0.1746
71744052|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.1626|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, IgA-positive class-switched B-cells||||0.1626
71777720|NCT03181893|143054475|OTHER||Least Squares Mean Difference|10.83|STANDARD_ERROR_OF_MEAN|10.274||0.1537|TWO_SIDED|90.0|-7.1|28.77|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 4||28.77|-7.10|0.1537
71777721|NCT03181893|143054475|OTHER||Least Squares Mean Difference|12.5|STANDARD_ERROR_OF_MEAN|10.761||0.1312|TWO_SIDED|90.0|-6.29|31.29|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 8||31.29|-6.29|0.1312
71777722|NCT03181893|143054475|OTHER||Least Squares Mean Difference|19.44|STANDARD_ERROR_OF_MEAN|12.161||0.0647|TWO_SIDED|90.0|-1.79|40.68|||Mixed Models Analysis|||Difference of the active treatment from Placebo at Week 12||40.68|-1.79|0.0647
71744053|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.6304|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Double-negative B-cells||||0.6304
71744054|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.3449|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 24, Plasmablasts||||0.3449
71744055|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.0919|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cell compartment||||0.0919
71744056|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.2189|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Transitional B-cells||||0.2189
71777723|NCT02128932|143054531|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.67|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.||-0.67|-0.96|<0.0001
71777724|NCT02128932|143054531|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%).|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.52|-0.24|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.||-0.24|-0.52|<0.0001
71777725|NCT01361568|143054540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|3.64|<|0.05|TWO_SIDED|95.0|-15.14|-0.78|||t-test, 2 sided|||||-0.78|-15.14|<0.05
71777726|NCT01361568|143054541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-420.0|STANDARD_ERROR_OF_MEAN|139.16|<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71777727|NCT01361568|143054541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-230.1|STANDARD_ERROR_OF_MEAN|92.26|<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71777728|NCT01361568|143054541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-260.4|STANDARD_ERROR_OF_MEAN|141.99||0.068||95.0|||||t-test, 2 sided|||||||0.068
71777729|NCT01361568|143054542|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.63|<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
71890927|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.68||||0.4374|TWO_SIDED|95.0|-20.2|8.84|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||8.84|-20.20|0.4374
71744057|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.1386|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Naive B-cells||||0.1386
71744058|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.6199|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Memory B-cells||||0.6199
71744059|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.1019|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Pre-switch memory B-cells||||0.1019
71744060|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.4353|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Post-switch memory B-cells||||0.4353
71777730|NCT01361568|143054542|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|1.74||0.059||95.0|||||Mixed Models Analysis|||||||0.059
71777731|NCT01361568|143054543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.41|<|0.05|TWO_SIDED|95.0|0.22|1.82|||t-test, 2 sided|||||1.82|0.22|<0.05
71777732|NCT01361568|143054543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.11|1.17|||t-test, 2 sided|||||1.17|0.11|<0.05
71777733|NCT01361568|143054544|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Degrees of freedom (df = 1)||||||0.001
71777734|NCT01361568|143054545|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71777735|NCT01361568|143054546|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
71777736|NCT00657358|143054547|SUPERIORITY_OR_OTHER||R^2 (adj)|0.477|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|DF=2 DFDEN=371.8, F-ratio=10.66||||||<0.001
71777737|NCT02959983|143054552|SUPERIORITY|||||||0.0022|||||||Chi-squared|||Overall Weeks 1-12||||0.0022
71777738|NCT02959983|143054553|SUPERIORITY|||||||0.0119|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0119
71777739|NCT02959983|143054553|SUPERIORITY|||||||0.0048|||||||Chi-squared|||Weeks 1 to 4||||0.0048
71777740|NCT02959983|143054553|SUPERIORITY|||||||0.0207|||||||Chi-squared|||Weeks 5 to 8||||0.0207
71777741|NCT02959983|143054553|SUPERIORITY|||||||0.37|||||||Chi-squared|||Weeks 9 to 12||||0.3700
71777742|NCT02959983|143054554|SUPERIORITY|||||||0.0174|||||||Chi-squared|||Overall Weeks 1 to 12||||0.0174
71777743|NCT02959983|143054554|SUPERIORITY|||||||0.3832|||||||Chi-squared|||Weeks 1 to 4||||0.3832
71777744|NCT02959983|143054554|SUPERIORITY|||||||0.0052|||||||Chi-squared|||Weeks 5 to 8||||0.0052
71777745|NCT02959983|143054554|SUPERIORITY|||||||0.0619|||||||Chi-squared|||Weeks 9 to 12||||0.0619
71777746|NCT02959983|143054555|SUPERIORITY|||||||0.033|||||||Chi-squared|||Weeks 1-4||||0.0330
71777747|NCT02959983|143054555|SUPERIORITY|||||||0.0063|||||||Chi-squared|||Weeks 5 to 8||||0.0063
71777748|NCT02959983|143054555|SUPERIORITY|||||||0.0018|||||||Chi-squared|||Weeks 9 to 12||||0.0018
71744061|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.3934|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgG-positive class-switched B-cells||||0.3934
71744062|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.4196|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, IgA-positive class-switched B-cells||||0.4196
71744063|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.5546|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Double-negative B-cells||||0.5546
71744064|NCT01332994|142998873|SUPERIORITY_OR_OTHER|||||||0.7695|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 32, Plasmablasts||||0.7695
71744065|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.6551|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cell compartment||||0.6551
71744066|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.6905|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Transitional B-cells||||0.6905
71744067|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.9678|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Naive B-cells||||0.9678
71744068|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.208|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Memory B-cells||||0.2080
71744069|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.4778|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Pre-switch memory B-cells||||0.4778
71744070|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.8526|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Post-switch memory B-cells||||0.8526
71744071|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.7266|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgG-positive class-switched B-cells||||0.7266
71744072|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.2011|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, IgA-positive class-switched B-cells||||0.2011
71777749|NCT02728596|143054556|SUPERIORITY||Odds Ratio (OR)|0.44||||0.21|TWO_SIDED|95.0|0.12|1.57|||Regression, Logistic|Adjusted for age group, comorbidity, race, and Hispanic ethnicity.||PP-CSF use in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||1.57|0.12|0.21
71777750|NCT02728596|143054556|SUPERIORITY||Odds Ratio (OR)|1.18||||0.74|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||3.20|0.44|0.74
71777751|NCT02728596|143054556|SUPERIORITY||Odds Ratio (OR)|2.23||||0.17|TWO_SIDED|95.0|0.7|7.08|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||7.08|0.70|0.17
71777752|NCT02728596|143054556|SUPERIORITY||Odds Ratio (OR)|0.36||||0.094|TWO_SIDED|95.0|0.11|1.19|||Regression, Logistic|Adjusted for age, sex, and cancer type.||PP-CSF use in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||1.19|0.11|0.094
71777753|NCT02728596|143054557|SUPERIORITY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.75|2.95|||Regression, Logistic|Adjusted for age.||FN incidence rate in the high risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||2.95|0.75|0.26
71777754|NCT02728596|143054557|SUPERIORITY||Odds Ratio (OR)|2.0||||0.51|TWO_SIDED|95.0|0.23|18.8|||Regression, Logistic|Adjusted for cancer type.||FN incidence rate in the low risk FN group was compared between the usual care (UC) group (Arm 2) and the intervention group (Arm 3 and 4 combined).||18.80|0.23|0.51
71777755|NCT02728596|143054557|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the SOE for PP-CSF intervention group (Arm 3).||2.88|0.41|0.87
71777756|NCT02728596|143054557|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|||FN incidence rate in the intermediate risk FN group was compared between the usual care (UC) group (Arm 2) and the alert against PP-CSF intervention group (Arm 4).||3.57|0.44|0.68
71744073|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.7872|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Double-negative B-cells||||0.7872
71777757|NCT02728596|143054558|SUPERIORITY||Odds Ratio (OR)|0.87||||0.74|TWO_SIDED|95.0|0.39|1.95|||Regression, Logistic|Adjusted for cancer type.||||1.95|0.39|0.74
71777758|NCT02728596|143054558|SUPERIORITY||Odds Ratio (OR)|1.09||||0.87|TWO_SIDED|95.0|0.41|2.88|||Regression, Logistic|Adjusted for cancer type.||||2.88|0.41|0.87
71777759|NCT02728596|143054558|SUPERIORITY||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.44|3.57|||Regression, Logistic|Adjusted for cancer type.||This is comparing the FN incidence rate in the arm randomized to alert against PP-CSF vs usual care in intermediate risk participants.||3.57|0.44|0.68
71777760|NCT03221270|143054570|SUPERIORITY|alternative hypothesis: true difference in means is greater than 0|Median Difference (Final Values)|-0.43||||0.66|ONE_SIDED|95.0|-2.25||||t-test, 1 sided||||||-2.25|0.66
71744074|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 16, Plasmablasts||||0.5377
71834365|NCT05107401|143172614|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.083|TWO_SIDED|95.0|-4.9|0.3|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.30|-4.90|0.083
71744075|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cell compartment||||0.6238
71744076|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Transitional B-cells||||0.2848
71834366|NCT05107401|143172615|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.032|TWO_SIDED|95.0|-1.16|-0.18|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, age, sex at birth, and sexual orientation.||-0.18|-1.16|0.032
71834367|NCT05107401|143172616|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.48|TWO_SIDED|95.0|-0.72|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-0.72|0.48
71834368|NCT05107401|143172617|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.48|TWO_SIDED|95.0|-1.49|0.29|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.29|-1.49|0.48
71834369|NCT05107401|143172618|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.37|TWO_SIDED|95.0|-2.6|0.51|||Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference between study arms from baseline to the three-month follow-up.|Separate multilevel linear mixed models were calculated for the overall stigma score and then for each of the stigma subscale scores. The multilevel linear mixed models incorporated random fixed effects for time (categorical), study arm, and their interaction and included intercept as a random effect. Models were also adjusted for pre-intervention stigma levels, whether the participant had submitted content to the study contest, prior HIV testing, age, sex at birth, and sexual orientation.||0.51|-2.60|0.37
71834370|NCT05107401|143172619|SUPERIORITY||Risk Ratio (RR)|1.13||||0.099|TWO_SIDED|95.0|0.98|1.32|||Regression, Logistic||The statistical values presented are the relative risk between study arms at the three-month follow-up.|We used a generalized linear model using a binomial distribution to examine whether the intervention was associated with increased HIV self-testing uptake in the follow-up period. The model was adjusted for history of HIV testing (pre-intervention testing and testing prior to the study), whether the participant had submitted content to the JasSpark contest, and if the participant had a main intimate partner (e.g., girlfriend/boyfriend, spouse).||1.32|0.98|0.099
71744077|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.6238|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Naive B-cells||||0.6238
71744078|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.2848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Pre-switch memory B-cells||||0.2848
71744079|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Post-switch memory B-cells||||0.7471
71744080|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.7471|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgG-positive class-switched B-cells||||0.7471
71744081|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, IgA-positive class-switched B-cells||||0.3910
71664522|NCT00094861|142842094|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0294||||0.8639||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.8639
71834371|NCT05107401|143172620|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.012|TWO_SIDED|95.0|-8.59|-1.58||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in females between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||-1.58|-8.59|0.012
71834372|NCT05107401|143172620|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.56|TWO_SIDED|95.0|-2.26|5.42||To account for multiple comparisons arising from analyses of moderating effects, the false discovery rate (FDR) was controlled using Benjamini-Hochberg procedures in a tiered approach.|Mixed Models Analysis||The statistical values presented are the Estimated Value of Mean Difference in males between study arms from baseline to the three-month follow-up.|Sex was marginally significant in the initial multilevel mixed models, therefore, we examined potential moderation effects of sex on stigma changes. Fixed effects corresponding to the two-way interactions involving sex, time, and/or arm, as well as the three-way interaction of sex, time, and arm, were added to the models.||5.42|-2.26|0.56
71834373|NCT03363854|143172621|SUPERIORITY||Risk Difference (RD)|12.4||||0.015|TWO_SIDED|95.0|2.9|21.9||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved IGA 0 or 1 at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their IGA value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||21.9|2.9|0.015
71890928|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Slope|-4.02||||0.5796|TWO_SIDED|95.0|-18.46|10.41|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||10.41|-18.46|0.5796
71744082|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.8729|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 48, Plasmablasts||||0.8729
71744083|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.7261|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cell compartment||||0.7261
71744084|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Transitional B-cells||||0.9338
71744085|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.9074|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Naive B-cells||||0.9074
71744086|NCT01332994|142998874|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Memory B-cells||||<0.0001
71744087|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.9338|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Pre-switch memory B-cells||||0.9338
71744088|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.6515|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Post-switch memory B-cells||||0.6515
71744089|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.8413|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgG-positive class-switched B-cells||||0.8413
71744090|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.7244|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, IgA-positive class-switched B-cells||||0.7244
71744091|NCT01332994|142998874|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Double-negative B-cells||||<0.0001
71744092|NCT01332994|142998874|SUPERIORITY_OR_OTHER|||||||0.3848|TWO_SIDED||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as \[square root of (n minus 2) x \[square root of (r\^2 divided by 1 minus r\^2)\].||Week 66, Plasmablasts||||0.3848
71744093|NCT00279916|142998893|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
71744094|NCT00279916|142998894|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
71744095|NCT02717494|142998918|OTHER||% with grade 3+ AEs, up to week 4 Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
71744096|NCT02717494|142998918|OTHER||% with grade 3+ AEs, up to week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|7.0|||||Confidence intervals were Exact Clopper-Pearson.|||7|1|
71744097|NCT02717494|142998918|OTHER||% with grade 3+ AEs up to week 4, Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
71744098|NCT02717494|142998918|OTHER||% with grade 4+ AEs after week 4, Step 1|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71744099|NCT02717494|142998918|OTHER||% with grade 4+ AEs after week 4, Step 1|2.0|||||TWO_SIDED|90.0|0.0|5.0|||||||Confidence intervals were Exact Clopper-Pearson.|5|0|
71744100|NCT02717494|142998918|OTHER||% with grade 4+ AEs, after week 4 Step 1|3.0|||||TWO_SIDED|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.|||8|1|
71744101|NCT02717494|142998918|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71744102|NCT02717494|142998918|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71744103|NCT02717494|142998918|OTHER||% with Grade 3+ related to treatment|1.0|||||TWO_SIDED|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.|||4|0|
71744104|NCT02717494|142998919|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
71744105|NCT02717494|142998919|OTHER||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||TWO_SIDED|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.|||5|0|
71744106|NCT02717494|142998920|OTHER||% infants with grade 3+ AEs|21.0|||||TWO_SIDED|90.0|14.0|28.0|||||Confidence intervals were Exact Clopper-Pearson.|||28|14|
71744107|NCT02717494|142998920|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||||Confidence intervals were Exact Clopper-Pearson.|27|14|
71744108|NCT02717494|142998920|OTHER||% infants with grade 3+ AEs|20.0|||||TWO_SIDED|90.0|14.0|27.0|||||Confidence intervals were Exact Clopper-Pearson.|||27|14|
71744109|NCT02717494|142998920|OTHER||% infants with congenital anomalies|17.0|||||TWO_SIDED|90.0|11.0|24.0|||||||Confidence intervals were Exact Clopper-Pearson.|24|11|
71744110|NCT02717494|142998920|OTHER||% infants with congenital anomalies|22.0|||||TWO_SIDED|90.0|15.0|29.0|||||||Confidence intervals were Exact Clopper-Pearson.|29|15|
71744111|NCT02717494|142998920|OTHER||% infants with congenital anomalies|13.0|||||TWO_SIDED|90.0|8.0|19.0|||||Confidence intervals were Exact Clopper-Pearson.|||19|8|
71744112|NCT02717494|142998920|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||||Confidence intervals were Exact Clopper-Pearson.|3|0|
71744113|NCT02717494|142998920|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|3.0|||||Confidence intervals were Exact Clopper-Pearson.|||3|0|
71744114|NCT02717494|142998920|OTHER||% infants with HIV infection|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Confidence intervals were Exact Clopper-Pearson.|||2|0|
71744115|NCT02717494|142998920|OTHER||% with pneumonia, meningitis or IPD|4.0|||||TWO_SIDED|90.0|2.0|9.0|||||Confidence intervals were Exact Clopper-Pearson.|||9|2|
71744116|NCT02717494|142998920|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
71744117|NCT02717494|142998920|OTHER||% with pneumonia, meningitis or IPD|7.0|||||TWO_SIDED|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
71744118|NCT02717494|142998921|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at day 28.||||||0.44||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.44
71744119|NCT02717494|142998921|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with values \>=0.35ug/mL at day 28.||||||0.49||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.49
71744120|NCT02717494|142998921|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.|||99|91|
71744121|NCT02717494|142998921|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|94|
71744122|NCT02717494|142998921|OTHER||% with >=2 fold increase|6.0|||||TWO_SIDED|95.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.|||12|3|
71744123|NCT02717494|142998921|OTHER||% vaccinees with >=0.35ug/mL at day 28|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
71744124|NCT02717494|142998921|OTHER||% vaccinees with >=0.35ug/mL at day 28|100.0|||||TWO_SIDED|95.0|97.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|97|
71744125|NCT02717494|142998921|OTHER||% with >=0.35ug/mL at day 28|94.0|||||TWO_SIDED|95.0|88.0|97.0|||||Confidence intervals were Exact Clopper-Pearson.|||97|88|
71744126|NCT02717494|142998922|SUPERIORITY|||||||0.29||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.29
71744127|NCT02717494|142998923|SUPERIORITY|||||||0.08||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.08
71744128|NCT02717494|142998924|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at labor and delivery.||||||0.37||||||The threshold for statistical significance is 0.05.|Chi-squared|||||||0.37
71744129|NCT02717494|142998924|SUPERIORITY|This is the test to compare the two vaccine arms with respect to proportion of participants with \>=2 fold increase at 24 weeks post partum.||||||0.21|||||||Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.||||||0.21
71744130|NCT02717494|142998925|OTHER||% vaccinees with >=2fold increase|96.0|||||TWO_SIDED|95.0|91.0|99.0||The threshold for statistical significance is 0.05.|||Confidence intervals were Exact Clopper-Pearson.|||99|91|
71744131|NCT02717494|142998925|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|89.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|89|
71744132|NCT02717494|142998926|OTHER||% vaccinees with >=2fold increase|98.0|||||TWO_SIDED|95.0|94.0|100.0|||||||Confidence intervals were Exact Clopper-Pearson.|100|94|
71744133|NCT02717494|142998926|OTHER||% vaccinees with >=2fold increase|100.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
71744134|NCT02717494|142998927|OTHER||% infants with >=0.35ug/mL at week 16|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
71777761|NCT05736224|143054608|SUPERIORITY|||||||0.003||||||No sunscreen compared to test sunscreen|t-test, 2 sided|||||||0.003
71777762|NCT00866788|143054617|SUPERIORITY_OR_OTHER|||||||0.1601||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1601
71777763|NCT00866788|143054617|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
71744135|NCT02717494|142998927|OTHER||% infants with >=0.35ug/mL at week 16|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
71664523|NCT00094861|142842095|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.1414||||0.1996||||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.||||||0.1996
71664524|NCT01917214|142842102|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Log Rank|||||||0.0308
71664525|NCT00000620|142842119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.12|TWO_SIDED|95.0|0.81|1.03||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.03|0.81|0.12
71744136|NCT02717494|142998927|OTHER||% infants with >=0.35ug/mL at week 16|97.0|||||TWO_SIDED|95.0|91.0|99.0|||||||Confidence intervals were Exact Clopper-Pearson.|99|91|
71744137|NCT02717494|142998927|OTHER||% infants with >=0.35ug/mL at week 24|100.0|||||TWO_SIDED|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|96|
71744138|NCT02717494|142998927|OTHER||% infants with >=0.35ug/mL at week 24|99.0|||||TWO_SIDED|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|95|
71744139|NCT02717494|142998927|OTHER||% infants with >=0.35ug/mL at week 24|98.0|||||TWO_SIDED|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.|||100|93|
71744140|NCT01598922|142998928|OTHER|Intent-to-treat (ITT) analyses following multiple imputation. Generalized Linear Models (GENLIN) predicting post-treatment HRSD scores in the imputed dataset. Covarying for pre-treatment HRSD scores, age and sex.|Odds Ratio (OR)|6.11|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|2.814|9.403|||GENLIN|||||9.403|2.814|<0.0001
71744141|NCT01598922|142998929|OTHER||Cohen's d measure of effect size|-0.79||||0.024|TWO_SIDED|95.0|-1.25|-0.32||Hierarchical Linear Modeling (HLM) was applied to PHQ-9 data, adjusting for baseline PHQ-9 score. Group x Time interactions tested for between-group differences in slope of improvement of PHQ-9 scores.|hierarchical linear modeling|Age and sex were covariates. Cohen's d effect sizes are reported.||||-0.32|-1.25|.024
71744142|NCT01598922|142998930|OTHER|Hierarchical Linear Modeling (HLM) was applied to K-10 data, adjusting for baseline K-10 score. Group x Time interactions tested for between-group differences in slope of improvement of K-10 scores.|Cohen's d measure of effect size|-0.95||||0.003|TWO_SIDED|95.0|-1.42|-0.48|||HLM|||The Kessler Psychological Distress Scale (K-10) is a 10-item scale with total scores that can range from 0 to 50. Higher scores represent worse (more severe) psychological distress.||-0.48|-1.42|.003
71744143|NCT00731679|142998936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.01
71744144|NCT00731679|142998937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.005
71744145|NCT04739436|142998981|SUPERIORITY||Slope|5.29||||0.003|TWO_SIDED|95.0|1.8|8.79||Multiple comparisons were not conducted, so no adjustment of the p-value was necessary.|Regression, Linear|||A linear regression model was fit with outcome change in APHAB score between 3 months and baseline, predictor hearing aid fitting group (reference=bilateral), and covariate clinical site.||8.79|1.80|0.003
71777764|NCT00866788|143054617|SUPERIORITY_OR_OTHER|||||||0.0473||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0473
71777765|NCT00866788|143054618|SUPERIORITY_OR_OTHER|||||||0.164||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1640
71777766|NCT00866788|143054618|SUPERIORITY_OR_OTHER|||||||0.0005||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0005
71777767|NCT00866788|143054618|SUPERIORITY_OR_OTHER|||||||0.0558||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0558
71777768|NCT00866788|143054619|SUPERIORITY_OR_OTHER|||||||0.1411||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1411
71777769|NCT00866788|143054619|SUPERIORITY_OR_OTHER|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0003
71777770|NCT00866788|143054619|SUPERIORITY_OR_OTHER|||||||0.0248||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0248
71777771|NCT00866788|143054620|SUPERIORITY_OR_OTHER|||||||0.5507||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.5507
71777772|NCT00866788|143054620|SUPERIORITY_OR_OTHER|||||||0.1525||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.1525
71777773|NCT00866788|143054620|SUPERIORITY_OR_OTHER|||||||0.0449||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.0449
71777774|NCT00866788|143054621|SUPERIORITY_OR_OTHER|||||||0.7261||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.7261
71777775|NCT00866788|143054621|SUPERIORITY_OR_OTHER|||||||0.162||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.162
71777776|NCT00866788|143054621|SUPERIORITY_OR_OTHER|||||||0.6504||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or \< 80 kg).|van Elteren test|||||||0.6504
71777777|NCT02742441|143054631|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
71777778|NCT02742441|143054632|SUPERIORITY||||||<|0.001||||||Statistical significance was achieved for each of the clinical signs of psoriasis.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).||||<0.001
71777779|NCT02742441|143054633|SUPERIORITY|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
71664526|NCT00000620|142842120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.02|TWO_SIDED|95.0|1.03|1.38||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.||1.38|1.03|0.02
71664527|NCT00000620|142842121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2|TWO_SIDED|95.0|0.73|1.06||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.||1.06|0.73|0.20
71664528|NCT00000620|142842122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.01|TWO_SIDED|95.0|0.39|0.89||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||0.89|0.39|0.01
71664529|NCT00000620|142842123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.32|TWO_SIDED|95.0|0.79|1.08||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.||1.08|0.79|0.32
71744146|NCT04739436|142998982|SUPERIORITY|||||||0.584||||||No adjustments for multiple comparisons were done.|Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, what proportion of the time do you wear your hearing aid?||||0.584
71744147|NCT04739436|142998982|SUPERIORITY|||||||0.233|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, how much does your hearing aid help you?||||0.233
71744148|NCT04739436|142998982|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: In this situation, with your hearing aid, how much difficulty do you now have?||||0.010
71777780|NCT04806503|143054646|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.006|STANDARD_ERROR_OF_MEAN|0.0258||0.817|TWO_SIDED|95.0|-0.045|0.056|||Mixed-effect Model for Repeated Measures|||||0.056|-0.045|0.817
71777781|NCT04806503|143054646|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.002|STANDARD_ERROR_OF_MEAN|0.0262||0.946|TWO_SIDED|95.0|-0.05|0.053|||Mixed-effect Model for Repeated Measures|||||0.053|-0.050|0.946
71777782|NCT04806503|143054646|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|-0.024|STANDARD_ERROR_OF_MEAN|0.027||0.38|TWO_SIDED|95.0|-0.077|0.029|||Mixed-effect Model for Repeated Measures|||||0.029|-0.077|0.380
71777783|NCT04806503|143054646|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.011|STANDARD_ERROR_OF_MEAN|0.0258||0.667|TWO_SIDED|95.0|-0.039|0.062|||Mixed-effect Model for Repeated Measures|||||0.062|-0.039|0.667
71664530|NCT00000620|142842124|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3|TWO_SIDED|95.0|0.85|1.05||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||||1.05|0.85|0.30
71664531|NCT02318303|142842129|SUPERIORITY||Mean Difference (Final Values)|-1.1087|||<|0.0001|TWO_SIDED|97.5|-1.669|-0.5485|||ANCOVA|||||-0.5485|-1.6690|<0.0001
71664532|NCT02318303|142842129|SUPERIORITY||Mean Difference (Final Values)|-1.1703|||<|0.0001|TWO_SIDED|97.5|-1.7315|-0.609|||ANCOVA|||||-0.6090|-1.7315|<0.0001
71664533|NCT02318303|142842129|SUPERIORITY||Mean Difference (Final Values)|-0.7718||||0.002|TWO_SIDED|95.0|-1.2616|-0.282|||ANCOVA|||||-0.2820|-1.2616|0.0020
71664534|NCT02318303|142842129|SUPERIORITY||Mean Difference (Final Values)|-0.3563||||0.1524|TWO_SIDED|95.0|-0.8445|0.1319|||ANCOVA|||||0.1319|-0.8445|0.1524
71664535|NCT02318303|142842129|SUPERIORITY||Mean Difference (Final Values)|-0.4918||||0.0488|TWO_SIDED|95.0|-0.981|-0.0025|||ANCOVA|||||-0.0025|-0.9810|0.0488
71664536|NCT02318303|142842129|SUPERIORITY||Mean Difference (Final Values)|-0.7133||||0.0043|TWO_SIDED|95.0|-1.2031|-0.2235|||ANCOVA|||||-0.2235|-1.2031|0.0043
71744149|NCT04739436|142998982|SUPERIORITY|||||||0.129|||||||Kruskal-Wallis|||The null hypothesis is there is no difference in the GHABP question means between the groups at 3 months for the question: For this situation, how satisfied are you with your hearing aid?||||0.129
71744150|NCT04739436|142998983|SUPERIORITY|||||||0.946|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 3 months in the co-located BKB SIN test scores between the groups.||||0.946
71744151|NCT04739436|142998984|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|No adjustments for multiple comparisons were done.||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recognition scores between the groups.||||0.490
71744152|NCT04739436|142998984|SUPERIORITY|||||||0.323||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypotheses are there are no differences in the change from baseline to 3 months in WARRM recall scores between the groups.||||0.323
71744153|NCT04739436|142998985|SUPERIORITY|||||||0.933||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 3 months.||||0.933
71744154|NCT04739436|142998985|SUPERIORITY|||||||0.929||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the SADL scores between the groups at 6 months.||||0.929
71664537|NCT00314951|142842136|NON_INFERIORITY_OR_EQUIVALENCE|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-2.9|8.0||||||H0: C(fidaxomicin) - C(Vancomycin) \<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.||8.0|-2.9|
71744155|NCT04739436|142998987|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||The null hypothesis is there is no difference in the change from baseline to 3 months in SSQ scores between the groups.||||0.015
71744156|NCT04739436|142998987|SUPERIORITY|||||||0.886|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change from baseline to 6 months in SSQ scores between the groups.||||0.886
71777784|NCT04806503|143054647|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.022|STANDARD_ERROR_OF_MEAN|0.0304||0.474|TWO_SIDED|95.0|-0.038|0.081|||Mixed-effect Model for Repeated Measures|||||0.081|-0.038|0.474
71777785|NCT04806503|143054647|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.025|STANDARD_ERROR_OF_MEAN|0.0309||0.419|TWO_SIDED|95.0|-0.036|0.086|||Mixed-effect Model for Repeated Measures|||||0.086|-0.036|0.419
71777786|NCT04806503|143054647|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.003|STANDARD_ERROR_OF_MEAN|0.0322||0.914||95.0|-0.06|0.067|||Mixed-effect Model for Repeated Measures|||||0.067|-0.060|0.914
71834374|NCT03363854|143172622|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|9.8|30.6||The primary endpoints were tested sequentially at a 5% significance level.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants who achieved at least 75% reduction in EASI at Week 16 were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16. The null hypothesis of no difference in response rates between tralokinumab Q2W+TCS and placebo+TCS was tested against the 2-sided alternative that there was a difference.||30.6|9.8|<0.001
71744157|NCT04739436|142998988|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the right ear.||||0.137
71744158|NCT04739436|142998988|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the number of hours of hearing aid use between the groups in the left ear.||||0.612
71744159|NCT04739436|142998990|SUPERIORITY|||||||0.108|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 3 months.||||0.108
71777787|NCT04806503|143054647|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.034|STANDARD_ERROR_OF_MEAN|0.0305||0.263|TWO_SIDED|95.0|-0.026|0.094|||Mixed-effect Model for Repeated Measures|||||0.094|-0.026|0.263
71777788|NCT04806503|143054648|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.029|STANDARD_ERROR_OF_MEAN|0.0273||0.284|TWO_SIDED|95.0|-0.024|0.083|||Mixed-effect Model for Repeated Measures|||||0.083|-0.024|0.284
71777789|NCT04806503|143054648|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.01|STANDARD_ERROR_OF_MEAN|0.0278||0.711|TWO_SIDED|95.0|-0.044|0.065|||Mixed-effect Model for Repeated Measures|||||0.065|-0.044|0.711
71777790|NCT04806503|143054648|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.005|STANDARD_ERROR_OF_MEAN|0.0284||0.871|TWO_SIDED|95.0|-0.051|0.06|||Mixed-effect Model for Repeated Measures|||||0.060|-0.051|0.871
71777791|NCT04806503|143054648|OTHER|Mixed-effect Model for Repeated Measures model-based two-sided t-test|Least Squares Mean|0.027|STANDARD_ERROR_OF_MEAN|0.0273||0.329|TWO_SIDED|95.0|-0.027|0.08|||Mixed-effect Model for Repeated Measures|||||0.080|-0.027|0.329
71664538|NCT00314951|142842137|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.4||||0.008|TWO_SIDED|95.0|-16.2|-2.5|||Chi-squared|||||-2.5|-16.2|0.008
71664539|NCT00314951|142842138|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.2||||0.007|TWO_SIDED|95.0|2.8|17.5|||Chi-squared|||||17.5|2.8|0.007
71744160|NCT04739436|142998990|SUPERIORITY|||||||0.988||||||No adjustments for multiple comparisons were done.|t-test, 2 sided|||The null hypothesis is there is no difference in the IOI-HA total score between the groups at 6 months.||||0.988
71744161|NCT04739436|142998993|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|No adjustments for multiple comparisons were done.||The null hypothesis is there is no difference in the change in APHAB score from baseline to 6 months between the groups.||||0.264
71744162|NCT00676013|142998994|OTHER|ANOVA and all pairwise comparisons using Tukey test.|Multiple pairwise comparisons|0.05||||0.05|TWO_SIDED|||||0.05 is a threshold for statistical significance.|ANOVA|||We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.|0.05|||0.05
71744163|NCT00428948|142998995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.708|||<|0.0001|TWO_SIDED|95.0|-3.269|-2.147|||Linear mixed model||The variance of the random effect intercept was zero and resulted in a non-positive, definite variance-covariance matrix for the random effects.|The null hypothesis was that there was no difference in the percentage change per year in total kidney volume between the tolvaptan group and the placebo group.||-2.147|-3.269|<0.0001
71744164|NCT00428948|142998996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.865||||0.0095|TWO_SIDED|95.0|0.775|0.965|||Recurrent event analysis||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the ADPKD clinical progression events/100 follow-up years between the tolvaptan group and the placebo group.||0.965|0.775|0.0095
71744165|NCT00428948|142998997|SUPERIORITY_OR_OTHER||Difference in slope|0.977|||<|0.0001|TWO_SIDED|95.0|0.597|1.357|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.||The null hypothesis was that there was no difference in the change in renal function per year between the tolvaptan group and the placebo group.||1.357|0.597|<0.0001
71777792|NCT04806503|143054649|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.95||||0.516|TWO_SIDED|95.0|0.083|10.847|||Multiple Imputation, Logistic Regression|||||10.847|0.083|0.516
71744166|NCT00428948|142998998|SUPERIORITY_OR_OTHER||Difference in slope|-0.246||||0.552|TWO_SIDED|95.0|-1.059|0.566|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.|Placebo minus tolvaptan.|The null hypothesis was that there was no difference in mean arterial blood pressure in non-hypertensive participants between the tolvaptan group and the placebo group.||0.566|-1.059|0.5520
71744167|NCT00428948|142998999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.1604|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|The analysis included baseline renal pain as a covariate.|Derived from ANCOVA with factors of treatment and baseline stratification factor interaction and covariate renal pain baseline.|The null hypothesis was that there was no difference in the change in renal pain between the tolvaptan group and the placebo group.||0.03|-0.20|0.1604
71777793|NCT04806503|143054649|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|2.45||||0.177|TWO_SIDED|95.0|0.367|16.398|||Multiple Imputation, Logistic Regression|||||16.398|0.367|0.177
71777794|NCT04806503|143054649|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|3.65||||0.079|TWO_SIDED|95.0|0.604|22.094|||Multiple Imputation, Logistic Regression|||||22.094|0.604|0.079
71777795|NCT04806503|143054649|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.07||||0.476|TWO_SIDED|95.0|0.136|8.381|||Multiple Imputation, Logistic Regression|||||8.381|0.136|0.476
71744168|NCT00428948|142999000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.9704|TWO_SIDED|95.0|0.805|1.233|||Recurrent event analysis||Derived from rate and mean model of time to recurrent event analysis with factor treatment.|The null hypothesis was that there was no difference in the hypertensive events per 100 follow-up years in non-hypertensive participants between the tolvaptan group and the placebo group.||1.233|0.805|0.9704
71777796|NCT04806503|143054650|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.87||||0.577|TWO_SIDED|95.0|0.201|3.726|||Multiple Imputation, Logistic Regression|||||3.726|0.201|0.577
71777797|NCT04806503|143054650|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.52||||0.804|TWO_SIDED|95.0|0.113|2.353|||Multiple Imputation, Logistic Regression|||||2.353|0.113|0.804
71777798|NCT04806503|143054650|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.34||||0.85|TWO_SIDED|95.0|0.045|2.602|||Multiple Imputation, Logistic Regression|||||2.602|0.045|0.850
71744169|NCT00428948|142999001|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.7532|TWO_SIDED|95.0|0.602|2.017|||Cochran-Mantel-Haenszel||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the percentage of participants with a clinically sustained decrease of blood pressure leading to a sustained reduction in antihypertensive therapy between the tolvaptan group and the placebo group.||2.017|0.602|0.7532
71744170|NCT02784171|142999003|SUPERIORITY|||||||0.0372|||||||Log Rank|||||||0.0372
71744171|NCT00330759|142999078|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.84||||0.0007||95.0|0.71|0.98|||Regression, Cox|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||||0.98|0.71|0.0007
71744172|NCT00330759|142999079|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.06||95.0|0.71|0.98|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||0.98|0.71|0.060
71744173|NCT00330759|142999080|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.145||95.0|0.77|1.04|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||1.04|0.77|0.145
71744174|NCT00997035|142999081|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.29|TWO_SIDED|95.0|0.57|1.18|||Regression, Cox|Cox proportional hazards regression to estimate the hazard of perforation or need for TPK.||The sample size was determined based on the primary end point: perforation or the need for TPK within 3 months. Simulation-based analyses estimated that a sample sizeof 240 study participants (120 per arm) would provide 80% power to detect a 15% difference in the 3-month perforation or need for TPK rate between topical antifungal plus oral voriconazole vs topical antifungal alone,with a 2-tailed α value of .05 and approximately 15%loss to follow-up.||1.18|0.57|0.29
71744175|NCT00997035|142999086|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.65|TWO_SIDED|95.0|0.49|1.57|||Regression, Cox|||||1.57|.49|0.65
71744176|NCT00997035|142999088|SUPERIORITY||||||<|0.001||||||Statistically significant after Holms-Šidák correction for multiple comparisons.|Fisher Exact|||||||<0.001
71744177|NCT03726489|142999097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.2|||<|0.001|TWO_SIDED|95.0|0.8|13.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||13.5|0.8|<0.001
71744178|NCT03726489|142999097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|-5.4|13.8||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||13.8|-5.4|<0.001
71744179|NCT03726489|142999097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.4|||<|0.001|TWO_SIDED|95.0|-2.2|17.0||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||17.0|-2.2|<0.001
71744180|NCT03726489|142999097|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|18.7|||<|0.001|TWO_SIDED|95.0|0.8|36.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||36.6|0.8|<0.001
71664540|NCT01120704|142842171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.906||||0.045|TWO_SIDED|95.0|0.822|0.998|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||.998|.822|.045
71664541|NCT01120704|142842171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.982||||0.705|TWO_SIDED|95.0|0.892|1.081|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.081|.892|.705
71744181|NCT03726489|142999097|OTHER|HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.||||||0.347||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.347
71744182|NCT03726489|142999098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|18.6|||<|0.001|TWO_SIDED|95.0|11.8|25.3||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||25.3|11.8|<0.001
71744183|NCT03726489|142999098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.2|||<|0.001|TWO_SIDED|95.0|11.0|31.5||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||31.5|11.0|<0.001
71744184|NCT03726489|142999098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.5|||<|0.001|TWO_SIDED|95.0|6.4|26.6||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||26.6|6.4|<0.001
71744185|NCT03726489|142999098|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%. The sample size for this subgroup did not meet our a priori sample size required for 80% power.|Risk Difference (RD)|16.1||||0.001|TWO_SIDED|95.0|-3.7|35.9||P-value was not adjusted for multiple comparisons. All p-values below 0.001 are reported as \<0.001.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.9|-3.7|0.001
71744186|NCT03726489|142999098|OTHER|||||||0.873||||||HTE was assessed using an omnibus Wald test of all interaction regression parameters in order to minimize multiple testing and consequent alpha inflation.|Regression, Logistic|We fit models for each of the two primary outcomes with skin type, treatment arm, and their interaction as predictors.||Analysis for heterogeneity of treatment effects (HTE) including all skin phototypes.||||0.873
71744187|NCT03726489|142999099|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.0001|TWO_SIDED|95.0|7.1|10.4||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||10.4|7.1|<0.0001
71744188|NCT03726489|142999099|SUPERIORITY||Mean Difference (Final Values)|9.38|||<|0.0001|TWO_SIDED|95.0|7.05|11.71||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||11.71|7.05|<0.0001
71744189|NCT03726489|142999099|SUPERIORITY||Mean Difference (Final Values)|8.48|||<|0.0001|TWO_SIDED|95.0|5.82|11.14||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||11.14|5.82|<0.0001
71664542|NCT01120704|142842171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.044||||0.382|TWO_SIDED|95.0|0.948|1.149|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.149|.948|.382
71664543|NCT01120704|142842171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.339|TWO_SIDED|95.0|0.867|1.05|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.050|.867|.339
71664544|NCT01120704|142842171|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.945||||0.248|TWO_SIDED|95.0|0.858|1.04|||Regression, Cox|||||1.040|.858|.248
71664545|NCT01120704|142842172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.402||||0.011|TWO_SIDED|95.0|1.08|1.821|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.||1.821|1.080|.011
71744190|NCT03726489|142999099|SUPERIORITY||Mean Difference (Final Values)|6.82||||0.0213|TWO_SIDED|95.0|1.06|12.58||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||12.58|1.06|0.0213
71744191|NCT03726489|142999100|SUPERIORITY||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|95.0|10.4|18.7||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||18.7|10.4|<0.0001
71664546|NCT01120704|142842172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.956|TWO_SIDED|95.0|0.769|1.321|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.321|.769|.956
71664547|NCT01120704|142842172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.018||||0.885|TWO_SIDED|95.0|0.797|1.301|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.||1.301|.797|.885
71664548|NCT01120704|142842172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.852||||0.205|TWO_SIDED|95.0|0.664|1.092|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.||1.092|.664|.205
71664549|NCT01120704|142842172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.514|TWO_SIDED|95.0|0.842|1.411|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.||1.411|.842|.514
71744192|NCT03726489|142999100|SUPERIORITY||Mean Difference (Final Values)|11.47|||<|0.0001|TWO_SIDED|95.0|6.93|16.01||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||16.01|6.93|<0.0001
71744193|NCT03726489|142999100|SUPERIORITY||Mean Difference (Final Values)|13.87|||<|0.0001|TWO_SIDED|95.0|7.77|19.98||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||19.98|7.77|<0.0001
71744194|NCT03726489|142999100|SUPERIORITY||Mean Difference (Final Values)|32.84||||0.0127|TWO_SIDED|95.0|7.32|58.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||58.35|7.32|0.0127
71744195|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.001|TWO_SIDED|95.0|-1.27|-0.35||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.35|-1.27|0.001
71744196|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.0158|TWO_SIDED|95.0|-1.51|-0.16||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.16|-1.51|0.0158
71744197|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.013|TWO_SIDED|95.0|-1.58|-0.19||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||-0.19|-1.58|0.0130
71744198|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.591|TWO_SIDED|95.0|-1.94|1.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||1.11|-1.94|0.5910
71744199|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.395|TWO_SIDED|95.0|-0.33|0.82||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes at Week 24||0.82|-0.33|0.395
71664550|NCT02728843|142842178|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664551|NCT02728843|142842179|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664552|NCT02728843|142842180|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664553|NCT02728843|142842181|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664554|NCT02728843|142842182|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664555|NCT02728843|142842183|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664556|NCT02728843|142842184|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71664557|NCT04123561|142842249|SUPERIORITY|"The primary efficacy endpoint is defined as the change from Injection 1 Baseline in WOMAC Pain on a normalized scale of 0-4 at Week 12 between the randomized TLC599 12mg and Placebo groups.~The least-squares mean, alongside its corresponding 95% confidence interval, was used to estimate the treatment difference between TLC599 and Placebo, utilizing two-sided p-values."|Least Squares Mean Difference (LSMD)|-0.171|STANDARD_ERROR_OF_MEAN|0.0819||0.0372|TWO_SIDED|95.0|-0.331|-0.01|||ANCOVA|Parameters estimated via REML using the Newton-Raphson algorithm, and the Kenward-Roger method calculates denominator degrees of freedom.||||-0.010|-0.331|0.0372
71664558|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16||0.459|TWO_SIDED|90.0|-1.05|-0.52|||Bayesian|||||-0.52|-1.05|0.459
71664559|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.16||0.511|TWO_SIDED|90.0|-1.07|-0.54|||Bayesian|||||-0.54|-1.07|0.511
71744200|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.774|TWO_SIDED|95.0|-0.69|0.93||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II at Week 24||0.93|-0.69|0.774
71744201|NCT03726489|142999101|SUPERIORITY||Median Difference (Final Values)|0.53||||0.242|TWO_SIDED|95.0|-0.36|1.41||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV at Week 24||1.41|-0.36|0.242
71777799|NCT04806503|143054650|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.69||||0.684|TWO_SIDED|95.0|0.157|3.08|||Multiple Imputation, Logistic Regression|||||3.080|0.157|0.684
71777800|NCT04806503|143054651|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.56||||0.728|TWO_SIDED|95.0|0.089|3.593|||Multiple Imputation, Logistic Regression|||||3.593|0.089|0.728
71777801|NCT04806503|143054651|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|1.16||||0.428|TWO_SIDED|95.0|0.242|5.529|||Multiple Imputation, Logistic Regression|||||5.529|0.242|0.428
71777802|NCT04806503|143054651|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.0||||0.5|TWO_SIDED|95.0|0.0||NA when n = 1.||Multiple Imputation, Logistic Regression||||||0.000|0.500
71664560|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|-1.15|STANDARD_ERROR_OF_MEAN|0.16||0.988|TWO_SIDED|90.0|-1.41|-0.89|||Bayesian|||||-0.89|-1.41|0.988
71664561|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.16||0.934|TWO_SIDED|90.0|-1.3|-0.78|||Bayesian|||||-0.78|-1.30|0.934
71664562|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.16||0.373|TWO_SIDED|90.0|0.08|0.61|||Bayesian|||||0.61|0.08|0.373
71664563|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.433|TWO_SIDED|90.0|0.07|0.59|||Bayesian|||||0.59|0.07|0.433
71744202|NCT03726489|142999101|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.692|TWO_SIDED|95.0|-2.72|1.83||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI at Week 24||1.83|-2.72|0.692
71744203|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-2.59||||0.1209|TWO_SIDED|95.0|-5.86|0.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation||0.68|-5.86|0.1209
71744204|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-2.13||||0.2581|TWO_SIDED|95.0|-6.0|1.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation||1.75|-6.0|0.2581
71744205|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-3.04||||0.2952|TWO_SIDED|95.0|-8.73|2.65||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation||2.65|-8.73|0.2952
71744206|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-2.61||||0.6324|TWO_SIDED|95.0|-13.12|7.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation||7.89|-13.12|0.6324
71744207|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|0.15||||0.9163|TWO_SIDED|95.0|-2.56|2.85||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation||2.85|-2.56|0.9163
71744208|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|0.31||||0.8551|TWO_SIDED|95.0|-3.03|3.66||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation||3.66|-3.03|0.8551
71744209|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|0.72||||0.7678|TWO_SIDED|95.0|-4.05|5.48||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation||5.48|-4.05|0.7678
71777803|NCT04806503|143054651|OTHER|Logistic model-based one-sided t-test|Odds Ratio (OR)|0.28||||0.851|TWO_SIDED|95.0|0.026|3.07|||Multiple Imputation, Logistic Regression|||||3.070|0.026|0.851
71664564|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.978|TWO_SIDED|90.0|-0.28|0.24|||Bayesian|||||0.24|-0.28|0.978
71664565|NCT02119819|142842404|SUPERIORITY||Posterior Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.904|TWO_SIDED|90.0|-0.17|0.35|||Bayesian|||||0.35|-0.17|0.904
71664566|NCT00264550|142842437|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.||||<0.001
71664567|NCT00264550|142842437|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||0.001
71664568|NCT00264550|142842437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \& IV).||||<0.001
71664569|NCT00264550|142842437|SUPERIORITY_OR_OTHER|||||||0.059||||||This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.|Chi-squared|||Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I \& II provides \>85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.||||0.059
71664570|NCT00264550|142842438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71664571|NCT00264550|142842438|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71664572|NCT00264550|142842438|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71664573|NCT00264550|142842438|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
71664574|NCT00264550|142842439|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.||||<0.001
71664575|NCT00264550|142842439|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.||||<0.001
71664576|NCT00264550|142842439|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.||||<0.001
71744210|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-3.03||||0.3446|TWO_SIDED|95.0|-8.88|2.82||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation||2.82|-8.88|0.3446
71664577|NCT00264550|142842439|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.||||0.240
71664578|NCT00264550|142842440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71744211|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-1.26||||0.5716|TWO_SIDED|95.0|-5.64|3.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Initiation at Week 24||3.11|-5.64|0.5716
71744212|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-0.44||||0.8756|TWO_SIDED|95.0|-6.03|5.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Initiation at Week 24||5.14|-6.03|0.8756
71744213|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-2.07||||0.5686|TWO_SIDED|95.0|-9.18|5.04||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Initiation at Week 24||5.04|-9.18|0.5686
71744214|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-1.39||||0.866|TWO_SIDED|95.0|-17.5|14.7||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Initiation at Week 24||14.7|-17.5|0.8660
71744215|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|0.19||||0.8779|TWO_SIDED|95.0|-2.24|2.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes - Discontinuation at Week 24||2.62|-2.24|0.8779
71744216|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|0.38||||0.7985|TWO_SIDED|95.0|-2.52|3.28||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II - Discontinuation at Week 24||3.28|-2.52|0.7985
71777804|NCT03423641|143054678|SUPERIORITY||Odds Ratio (OR)|0.81||||0.68|TWO_SIDED|95.0|0.3|2.2|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||2.20|0.30|.68
71777805|NCT03423641|143054679|SUPERIORITY||Odds Ratio (OR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.91|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.91|0.56|0.01
71777806|NCT03423641|143054680|SUPERIORITY||Odds Ratio (OR)|0.92||||0.39|TWO_SIDED|95.0|0.75|1.12|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.12|0.75|0.39
71664579|NCT00264550|142842440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71664580|NCT00264550|142842440|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71664581|NCT00264550|142842440|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Chi-squared|||||||0.187
71664582|NCT00264550|142842441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden noramal|||||||<0.001
71664583|NCT00264550|142842441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
71664584|NCT00264550|142842441|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|||||||<0.001
71664585|NCT00264550|142842441|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||ANOVA on van der Waerden normal scores|||||||0.097
71664586|NCT00264550|142842442|SUPERIORITY_OR_OTHER|||||||0.551|||||||ANOVA on van der Waerden normal|||||||0.551
71664587|NCT00264550|142842442|SUPERIORITY_OR_OTHER|||||||0.953|||||||ANOVA on van der Waerden normal scores|||||||0.953
71664588|NCT00264550|142842442|SUPERIORITY_OR_OTHER|||||||0.293|||||||ANOVA on van der waerden normal scores|||||||0.293
71664589|NCT00264550|142842442|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANOVA on van der Waerden normal scores|||||||0.361
71664590|NCT00696787|142842462|SUPERIORITY_OR_OTHER||Adjusted mean|-0.38||||0.471|TWO_SIDED|95.0|-1.42|0.66|||ANCOVA|||||0.66|-1.42|0.471
71664591|NCT00696787|142842462|SUPERIORITY_OR_OTHER||Adjusted mean|-0.28||||0.604|TWO_SIDED|95.0|-1.33|0.77|||ANCOVA|||||0.77|-1.33|0.604
71664592|NCT00696787|142842463|SUPERIORITY_OR_OTHER||Adjusted mean|-0.35||||0.51|TWO_SIDED|95.0|-1.42|0.71|||ANCOVA|||||0.71|-1.42|0.510
71664593|NCT00696787|142842463|SUPERIORITY_OR_OTHER||Adjusted mean|-0.55||||0.317|TWO_SIDED|95.0|-1.64|0.54|||ANCOVA|||||0.54|-1.64|0.317
71664594|NCT01549405|142842477|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mann-Whitney U test|||||||0.002
71664595|NCT01549405|142842478|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.1|STANDARD_DEVIATION|58.0||0|TWO_SIDED|95.0|52.98|132.4|||t-test, 2 sided|||||132.4|52.98|0.000
71664596|NCT01191944|142842479|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority (NI) margin of -4 points|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.9192|<|0.0001||95.0|-1.047|2.566||one-sided test relative to NI margin of -4|ANCOVA|adjusted for treatment, centre and baseline|Pramipexole IR minus Pramipexole ER, Pramipexole ER non inferior to Pramipexole IR if lower limit of confidence interval (CI) for the mean difference is higher than NI margin.|The null hypothesis (H0) states that the mean change from baseline to Week 18 (or last observation carried forward \[LOCF\]) in the UPDRS II+III score for the treatment group pramipexole ER is inferior to the mean change for the treatment group pramipexole IR.||2.566|-1.047|<0.0001
71664597|NCT01191944|142842480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.1836||0.8261|TWO_SIDED|95.0|-4.787|3.826|||ANCOVA|||||3.826|-4.787|0.8261
71664598|NCT01191944|142842481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.3274||0.8698|TWO_SIDED|95.0|-0.699|0.592|||ANCOVA|||||0.592|-0.699|0.8698
71664599|NCT01191944|142842482|SUPERIORITY_OR_OTHER|||||||0.7902||95.0|||||Cochran-Mantel-Haenszel|||||||0.7902
71744217|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|0.69||||0.7585|TWO_SIDED|95.0|-3.71|5.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV - Discontinuation at Week 24||5.09|-3.71|0.7585
71744218|NCT03726489|142999102|SUPERIORITY||Risk Difference (RD)|-2.78||||0.3422|TWO_SIDED|95.0|-8.15|2.59||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI - Discontinuation at Week 24||2.59|-8.15|0.3422
71744219|NCT03726489|142999103|SUPERIORITY||Mean Difference (Final Values)|-3.2||||0.094|TWO_SIDED|95.0|-6.95|0.55||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||0.55|-6.95|0.094
71744220|NCT03726489|142999103|SUPERIORITY||Mean Difference (Final Values)|-5.26||||0.0393|TWO_SIDED|95.0|-10.26|-0.26||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||-0.26|-10.26|0.0393
71744221|NCT03726489|142999103|SUPERIORITY||Mean Difference (Final Values)|-3.92||||0.1505|TWO_SIDED|95.0|-9.28|1.44||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||1.44|-9.28|0.1505
71744222|NCT03726489|142999103|SUPERIORITY||Mean Difference (Final Values)|10.42||||0.284|TWO_SIDED|95.0|-9.0|29.84||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||29.84|-9.0|0.2840
71744223|NCT03726489|142999104|OTHER||Mean|19.87|STANDARD_DEVIATION|61.6|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
71744224|NCT03726489|142999104|OTHER||Mean|18.06|STANDARD_DEVIATION|57.04|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
71744225|NCT03726489|142999104|OTHER||Mean|23.46|STANDARD_DEVIATION|70.71|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
71744226|NCT03726489|142999104|OTHER||Mean|9.22|STANDARD_DEVIATION|5.66|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
71744227|NCT03726489|142999105|OTHER||Mean|50.3|STANDARD_DEVIATION|46.7|||TWO_SIDED|||||P-value is not applicable.||||Overall analysis adjusted for all skin phototypes||||
71744228|NCT03726489|142999105|OTHER||Mean|53.19|STANDARD_DEVIATION|50.05|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes I/II||||
71744229|NCT03726489|142999105|OTHER||Mean|49.82|STANDARD_DEVIATION|47.43|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes III/IV||||
71744230|NCT03726489|142999105|OTHER||Mean|39.72|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||P-value is not applicable.||||Analysis for Phototypes V/VI||||
71777807|NCT03423641|143054681|SUPERIORITY||Odds Ratio (OR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.9|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.90|0.49|0.01
71777808|NCT03423641|143054682|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.01|TWO_SIDED|95.0|0.3|0.59|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.59|0.30|<0.01
71664600|NCT01191944|142842483|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.763|STANDARD_ERROR_OF_MEAN|2.7845||0.3223|TWO_SIDED|95.0|-8.255|2.729|||ANCOVA|||||2.729|-8.255|0.3223
71664601|NCT01191944|142842484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|1.5581||0.0254|TWO_SIDED|95.0|0.437|6.583|||ANCOVA|||||6.583|0.437|0.0254
71664602|NCT01191944|142842485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.621|STANDARD_ERROR_OF_MEAN|2.2658||0.7843|TWO_SIDED|95.0|-3.848|5.09|||ANCOVA|||||5.090|-3.848|0.7843
71664603|NCT01191944|142842486|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.369|STANDARD_ERROR_OF_MEAN|0.4901||0.4529|TWO_SIDED|95.0|-0.598|1.335|||ANCOVA|||||1.335|-0.598|0.4529
71664604|NCT01191944|142842487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.4437||0.2338|TWO_SIDED|95.0|-1.405|0.345|||ANCOVA|||||0.345|-1.405|0.2338
71664605|NCT01191944|142842488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562|STANDARD_ERROR_OF_MEAN|0.2509||0.0263|TWO_SIDED|95.0|0.067|1.057|||ANCOVA|||||1.057|0.067|0.0263
71664606|NCT01191944|142842489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.3727||0.9337|TWO_SIDED|95.0|-0.704|0.766|||ANCOVA|||||0.766|-0.704|0.9337
71744231|NCT03726489|142999106|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|11.97|||<|0.0001|TWO_SIDED|95.0|6.52|17.42||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||17.42|6.52|<0.0001
71744232|NCT03726489|142999106|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|16.15|||<|0.0001|TWO_SIDED|95.0|7.54|24.75||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.75|7.54|<0.0001
71744233|NCT03726489|142999106|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|5.56|||<|0.0001|TWO_SIDED|95.0|-2.35|13.46||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||13.46|-2.35|<0.0001
71744234|NCT03726489|142999106|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|21.37|||<|0.0001|TWO_SIDED|95.0|7.65|35.09||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||35.09|7.65|<0.0001
71744235|NCT03726489|142999107|SUPERIORITY||Risk Difference (RD)|11.68||||0.0065|TWO_SIDED|95.0|3.27|20.08||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||20.08|3.27|0.0065
71664607|NCT01191944|142842490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.0798||0.6995|TWO_SIDED|95.0|-0.127|0.188|||ANCOVA|||||0.188|-0.127|0.6995
71664608|NCT01191944|142842491|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Cochran-Mantel-Haenszel|||||||0.3170
71664609|NCT01191944|142842492|SUPERIORITY_OR_OTHER|||||||0.4756||95.0|||||Cochran-Mantel-Haenszel|||||||0.4756
71664610|NCT01191944|142842493|SUPERIORITY_OR_OTHER|||||||0.1051||95.0|||||Cochran-Mantel-Haenszel|||||||0.1051
71744236|NCT03726489|142999107|SUPERIORITY||Risk Difference (RD)|12.31||||0.0478|TWO_SIDED|95.0|0.03|24.49||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||24.49|0.03|0.0478
71744237|NCT03726489|142999107|SUPERIORITY||Risk Difference (RD)|13.25||||0.0431|TWO_SIDED|95.0|0.52|25.98||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||25.98|0.52|0.0431
71744238|NCT03726489|142999107|SUPERIORITY||Risk Difference (RD)|1.5||||0.9133|TWO_SIDED|95.0|-25.5|28.5||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||28.50|-25.50|0.9133
71744239|NCT03726489|142999108|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.048|TWO_SIDED|95.0|-15.73|-0.07||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||-0.07|-15.73|0.048
71834375|NCT03363854|143172623|SUPERIORITY||Risk Difference (RD)|11.3||||0.037|TWO_SIDED|95.0|0.9|21.6||This secondary endpoint was tested after the sequential testing of the primary endpoints, if these showed statistical significance.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their Worst daily Pruritus NRS value at Week 16.||21.6|0.9|0.037
71744240|NCT03726489|142999108|SUPERIORITY||Mean Difference (Final Values)|-10.67||||0.1199|TWO_SIDED|95.0|-24.15|2.8||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||2.80|-24.15|0.1199
71744241|NCT03726489|142999108|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.2953|TWO_SIDED|95.0|-15.26|4.66||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||4.66|-15.26|0.2953
71744242|NCT03726489|142999108|SUPERIORITY||Mean Difference (Final Values)|-8.83||||0.5124|TWO_SIDED|95.0|-35.77|18.11||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||18.11|-35.77|0.5124
71744243|NCT03726489|142999109|SUPERIORITY||Risk Difference (RD)|10.9||||0.0173|TWO_SIDED|95.0|1.93|19.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||19.87|1.93|0.0173
71664611|NCT01191944|142842494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.3138||0.6237|TWO_SIDED|95.0|-0.463|0.771|||ANCOVA|||||0.771|-0.463|0.6237
71664612|NCT01191944|142842496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.628|STANDARD_ERROR_OF_MEAN|0.7088||0.376|TWO_SIDED|95.0|-0.765|2.021|||ANCOVA|||||2.021|-0.765|0.3760
71664613|NCT00603837|142842501|SUPERIORITY_OR_OTHER|||||||0.445||95.0|||||t-test, 1 sided|||||||0.445
71664614|NCT03578549|142842517|OTHER||Correlation Coefficient|0.01||||0.92|TWO_SIDED||||||ANOVA|||||||0.92
71664615|NCT04414345|142842526|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.797|1.188||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. CNM-Au8 slowed progression) was 0.59059. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by CNM-Au8 relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||"The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality.~The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes."|1.188|0.797|
71664616|NCT04414345|142842528|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.766||0.657|TWO_SIDED|95.0|-4.25|2.68|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||2.68|-4.25|0.6570
71664617|NCT04414345|142842529|SUPERIORITY||Mean Difference (Net)|-3.1|STANDARD_ERROR_OF_MEAN|3.403||0.3621|TWO_SIDED|95.0|-9.78|3.58|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|CNM-Au8 24-week change from baseline relative to placebo 24-week change from baseline.|||3.58|-9.78|0.3621
71664618|NCT04414345|142842530|SUPERIORITY|||||||0.7398|||||||Log Rank|||||||0.7398
71744244|NCT03726489|142999109|SUPERIORITY||Risk Difference (RD)|13.06||||0.0662|TWO_SIDED|95.0|-0.81|26.94||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||26.94|-0.81|0.0662
71664619|NCT01851330|142842537|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71744245|NCT03726489|142999109|SUPERIORITY||Risk Difference (RD)|8.58||||0.1976|TWO_SIDED|95.0|-4.42|21.57||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||21.57|-4.42|0.1976
71744246|NCT03726489|142999109|SUPERIORITY||Risk Difference (RD)|13.04||||0.3595|TWO_SIDED|95.0|-14.6|40.69||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||40.69|-14.60|0.3595
71744247|NCT03726489|142999110|SUPERIORITY||Risk Difference (RD)|7.55||||0.0853|TWO_SIDED|95.0|-1.05|16.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||16.14|-1.05|0.0853
71744248|NCT03726489|142999110|SUPERIORITY||Risk Difference (RD)|2.26||||0.7488|TWO_SIDED|95.0|-11.54|16.06||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||16.06|-11.54|0.7488
71744249|NCT03726489|142999110|SUPERIORITY||Risk Difference (RD)|10.12||||0.1051|TWO_SIDED|95.0|-2.03|22.26||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||22.26|-2.03|0.1051
71744250|NCT03726489|142999110|SUPERIORITY||Risk Difference (RD)|17.39||||0.1792|TWO_SIDED|95.0|-7.48|42.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||42.27|-7.48|0.1792
71744251|NCT03726489|142999111|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.175|TWO_SIDED|95.0|-1.37|7.5||P-value was not adjusted for multiple comparisons.|Regression, Linear|Adjusted for skin phototype||Overall analysis adjusted for all skin phototypes||7.50|-1.37|0.175
71744252|NCT03726489|142999111|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.8904|TWO_SIDED|95.0|-6.34|5.51||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes I/II||5.51|-6.34|0.8904
71744253|NCT03726489|142999111|SUPERIORITY||Mean Difference (Final Values)|7.59||||0.0412|TWO_SIDED|95.0|0.31|14.88||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes III/IV||14.88|0.31|0.0412
71744254|NCT03726489|142999111|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.5481|TWO_SIDED|95.0|-13.38|24.38||P-value was not adjusted for multiple comparisons.|Regression, Linear|||Analysis for Phototypes V/VI||24.38|-13.38|0.5481
71744255|NCT03726489|142999111|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.458|TWO_SIDED|95.0|0.471|1.403|||Regression, Cox|Failure event corresponds to DLQI assessment greater than 5. Model adjusted for skin phototype.|Office phototherapy is the reference group.|Cox proportional hazards model for maintaining treatment response after week 12.||1.403|0.471|0.458
71744256|NCT03726489|142999112|SUPERIORITY||Risk Difference (RD)|38.1|||<|0.0001|TWO_SIDED|95.0|30.34|45.86||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis adjusted for all skin phototypes||45.86|30.34|<0.0001
71744257|NCT03726489|142999112|SUPERIORITY||Risk Difference (RD)|38.86|||<|0.0001|TWO_SIDED|95.0|27.39|50.33||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||50.33|27.39|<0.0001
71744258|NCT03726489|142999112|SUPERIORITY||Risk Difference (RD)|42.21|||<|0.0001|TWO_SIDED|95.0|30.73|53.68||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||53.68|30.73|<0.0001
71744259|NCT03726489|142999112|SUPERIORITY||Risk Difference (RD)|15.74||||0.234|TWO_SIDED|95.0|-9.63|41.11||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||41.11|-9.63|0.2340
71744260|NCT03726489|142999113|SUPERIORITY||Risk Difference (RD)|43.96|||<|0.0001|TWO_SIDED|95.0|37.25|50.66||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||50.66|37.25|<0.0001
71744261|NCT03726489|142999113|SUPERIORITY||Risk Difference (RD)|39.85|||<|0.0001|TWO_SIDED|95.0|30.0|49.7||P-value was not adjusted for multiple comparisons.|Marginal Standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||49.70|30.0|<0.0001
71744262|NCT03726489|142999113|SUPERIORITY||Risk Difference (RD)|50.18|||<|0.0001|TWO_SIDED|95.0|40.09|60.27||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||60.27|40.09|<0.0001
71744263|NCT03726489|142999113|SUPERIORITY||Risk Difference (RD)|36.11|||<|0.0001|TWO_SIDED|95.0|14.35|57.87||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||57.87|14.35|<0.0001
71777809|NCT03423641|143054683|SUPERIORITY||Odds Ratio (OR)|0.68||||0.12|TWO_SIDED|95.0|0.42|1.1|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.10|0.42|0.12
71744264|NCT03726489|142999114|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-5.2||||0.1773|TWO_SIDED|95.0|-19.4|9.0||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||9.0|-19.4|0.1773
71777810|NCT03423641|143054684|SUPERIORITY||Odds Ratio (OR)|0.61||||0.34|TWO_SIDED|95.0|0.22|1.7|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.70|0.22|0.34
71744265|NCT03726489|142999114|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-6.88||||0.4073|TWO_SIDED|95.0|-26.09|12.33||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||12.33|-26.09|0.4073
71744266|NCT03726489|142999114|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|-12.42||||0.8247|TWO_SIDED|95.0|-35.24|10.41||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||10.41|-35.24|0.8247
71744267|NCT03726489|142999114|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|37.88||||0.0133|TWO_SIDED|95.0|-4.01|79.77||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||79.77|-4.01|0.0133
71744268|NCT03726489|142999115|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|6.52||||0.002|TWO_SIDED|95.0|-7.11|20.14||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Overall analysis including all skin phototypes||20.14|-7.11|0.002
71744269|NCT03726489|142999115|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|7.77||||0.0137|TWO_SIDED|95.0|-10.35|25.89||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes I/II||25.89|-10.35|0.0137
71744270|NCT03726489|142999115|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|1.0||||0.1656|TWO_SIDED|95.0|-21.61|23.61||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes III/IV||23.61|-21.61|0.1656
71744271|NCT03726489|142999115|NON_INFERIORITY|Statistical inference was based on non-inferiority principles using a non-inferiority margin of 15%.|Risk Difference (RD)|22.73||||0.1225|TWO_SIDED|95.0|-25.16|70.62||P-value was not adjusted for multiple comparisons.|Marginal standardization|Test statistic is based on risk difference and standard error calculated using marginal standardization from adjusted logistic regression estimates||Analysis for Phototypes V/VI||70.62|-25.16|0.1225
71744272|NCT03726489|142999116|SUPERIORITY||Risk Difference (RD)|0.105||||0.0183|TWO_SIDED|95.0|0.018|0.192|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 16. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.192|0.018|0.0183
71744273|NCT03726489|142999116|SUPERIORITY||Risk Difference (RD)|0.064||||0.177|TWO_SIDED|95.0|-0.029|0.158|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 20. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.158|-0.029|0.177
71777811|NCT03423641|143054685|SUPERIORITY||Marginal Structural Model|0.61|||<|0.01|TWO_SIDED|95.0|0.49|0.76|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.76|0.49|<0.01
71777812|NCT03423641|143054686|SUPERIORITY||Rate Ratio|0.71|||<|0.01|TWO_SIDED|95.0|0.6|0.84|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.84|0.60|<0.01
71777813|NCT03423641|143054687|SUPERIORITY||Rate Ratio|0.82|||<|0.01|TWO_SIDED|95.0|0.77|0.87|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.|||0.87|0.77|<0.01
71777814|NCT03423641|143054688|SUPERIORITY||Odds Ratio (OR)|0.47||||0.02|TWO_SIDED|95.0|0.25|0.88|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||0.88|0.25|0.02
71777815|NCT03423641|143054689|SUPERIORITY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.37|1.03|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.03|0.37|0.07
71777816|NCT03423641|143054690|SUPERIORITY||Odds Ratio (OR)|0.81||||0.11|TWO_SIDED|95.0|0.63|1.05|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.|||1.05|0.63|0.11
71777817|NCT00850070|143054713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.35|||||||Chi-squared||Estimated value comparison was active treatment minus placebo.|Chi-square analyses were used to assess CGI-I scores. There were no transformations.||||<.35
71777818|NCT00850070|143054714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||<|0.06|||||||Chi-squared|||||||<0.06
71777819|NCT00850070|143054720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.05|||||||Mixed Models Analysis|||||||0.05
71777820|NCT00074984|143054723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.1449|TWO_SIDED|95.0|0.269|1.222|||Log Rank|Comparison is based on a 2-sided log-rank test.||||1.222|0.269|0.1449
71777821|NCT00074984|143054723|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.465||||0.0577|TWO_SIDED|95.0|0.211|1.025|||Wald Test|||Time to First Primary Endpoint Adjusting for Baseline Proteinuria using Cox Proportional Hazards Model||1.025|0.211|0.0577
71777822|NCT00074984|143054724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5261|TWO_SIDED|95.0|0.278|1.927|||Log Rank|2-sided log-rank test||Analysis of Time to First Renal Event for ITT population.||1.927|0.278|0.5261
71777823|NCT01904058|143054783|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.28||||0.6603|TWO_SIDED|95.0|-12.59|8.03||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.||8.03|-12.59|0.6603
71777824|NCT01904058|143054783|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.438|TWO_SIDED|95.0|-14.2|6.23||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.||6.23|-14.20|0.4380
71777825|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.09||||0.42|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 3||||0.42
71777826|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.32|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 3||||0.32
71777827|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.36|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 3||||0.36
71777828|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.17||||0.23|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Regimen-Related Distress Subscale - Treatment Effect - Month 3||||0.23
71834376|NCT03363854|143172624|SUPERIORITY||Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-15.2|-6.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-6.6|-15.2|<0.001
71777829|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression model with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.18||||0.26|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 3||||0.26
71777830|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Treatment Effect|0.007||||0.95|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Total Score - Treatment Effect - Month 6||||0.95
71777831|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.01||||0.92|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Emotional Burden Subscale - Treatment Effect - Month 6||||0.92
71890929|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66||||0.7994|TWO_SIDED|95.0|-11.32|14.64|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05||14.64|-11.32|0.7994
71890930|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.75||||0.2784|TWO_SIDED|95.0|-6.42|21.93|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.93|-6.42|0.2784
71890931|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.68||||0.3581|TWO_SIDED|95.0|-7.75|21.12|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||21.12|-7.75|0.3581
71744274|NCT03726489|142999116|SUPERIORITY||Risk Difference (RD)|-0.011||||0.815|TWO_SIDED|95.0|-0.101|0.079|||Marginal contrast||Positive values indicate higher proportion in the home group.|Difference of proportion at week 24. Calculated using contrasts of predictive margins following logistic regression with robust variance estimators via generalized estimating equations and exchangeable correlation. Missing data for DLQI are imputed using multiple imputation via chained equations (10 imputations), and the estimates are combined using standard rules.||0.079|-0.101|0.815
71744275|NCT04057807|142999127|SUPERIORITY|||||||0.14|||||||unpaired t-tests (continuous variables)|||||||0.14
71744276|NCT04057807|142999128|SUPERIORITY|||||||0.82|||||||univariate linear regression analysis|two-tailed P value was obtained from a univariate linear regression analysis||||||0.82
71744277|NCT00786799|142999138|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_DEVIATION|6.1||0.4|||||||t-test, 2 sided|||The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.||||0.40
71744278|NCT01072188|142999185|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71744279|NCT01072188|142999186|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71744280|NCT03956550|142999209|SUPERIORITY|||||||0.2978|||||||Mixed Models Analysis|||||||0.2978
71744281|NCT03956550|142999209|SUPERIORITY|||||||0.689|||||||Mixed Models Analysis|||||||0.6890
71744282|NCT03956550|142999210|SUPERIORITY|||||||0.1973|||||||Mixed Models Analysis|||||||0.1973
71744283|NCT03956550|142999210|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||0.9420
71744284|NCT03956550|142999211|SUPERIORITY|||||||0.1597|||||||Mixed Models Analysis|||||||0.1597
71744285|NCT03956550|142999211|SUPERIORITY|||||||0.9719|||||||Mixed Models Analysis|||||||0.9719
71744286|NCT03956550|142999212|SUPERIORITY|||||||0.1365|||||||Mixed Models Analysis|||||||0.1365
71777832|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.07||||0.59|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physician-Related Distress Subscale - Treatment Effect - Month 6||||0.59
71664620|NCT01851330|142842537|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71744287|NCT03956550|142999212|SUPERIORITY|||||||0.0604|||||||Mixed Models Analysis|||||||0.0604
71744288|NCT03956550|142999213|SUPERIORITY|||||||0.0989|||||||Mixed Models Analysis|||||||0.0989
71744289|NCT03956550|142999213|SUPERIORITY|||||||0.5487|||||||Mixed Models Analysis|||||||0.5487
71744290|NCT03956550|142999214|SUPERIORITY|||||||0.3572|||||||Cochran-Mantel-Haenszel|||||||0.3572
71744291|NCT03956550|142999214|SUPERIORITY|||||||0.5747|||||||Cochran-Mantel-Haenszel|||||||0.5747
71744292|NCT00287222|142999228|SUPERIORITY_OR_OTHER||percentage progression free at 27 weeks|28.0|STANDARD_ERROR_OF_MEAN|10.97||0.0006|TWO_SIDED|95.0|10.0|53.0|||one-sided exact binomial test|||Estimating the percentage of participants that remain free of disease progression at 27 weeks from the onset of treatment, and testing that proportion against a null-hypothesis proportion of 0.04 using the one-sided exact binomial test at 5% alpha, based upon historical data from the literature.||53|10|0.0006
71744293|NCT00824473|142999229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4286|STANDARD_ERROR_OF_MEAN|0.351|<|0.001||95.0|-2.12|-0.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.74|-2.12|<0.001
71744294|NCT00824473|142999230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6063|STANDARD_ERROR_OF_MEAN|0.1697|<|0.001||95.0|-0.94|-0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.27|-0.94|<0.001
71744295|NCT00824473|142999231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3947|STANDARD_ERROR_OF_MEAN|0.3391|<|0.001||95.0|-2.06|-0.73|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline||-0.73|-2.06|<0.001
71744296|NCT00824473|142999232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9284|STANDARD_ERROR_OF_MEAN|0.2741|<|0.001||95.0|-1.47|-0.39|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||reflective TOSS change in baseline||-0.39|-1.47|<0.001
71744297|NCT00824473|142999233|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||change from baseline||||0.010
71744298|NCT01359904|142999235|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||||||0.027
71744299|NCT01359904|142999236|SUPERIORITY_OR_OTHER|||||||0.67|||||||Kruskal-Wallis|||post intervention hemoglobin A1c levels||||0.67
71744300|NCT01359904|142999237|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
71744301|NCT01359904|142999238|SUPERIORITY_OR_OTHER|||||||0.32|||||||Chi-squared|||||||0.32
71744302|NCT03369418|142999266|SUPERIORITY|One tailed t-tests for independent groups were performed to test the hypothesis that active device will be superior to sham in decreasing the combined HAD score. This was accomplished by Contrast analysis within the framework of a random effects general linear mixed effects (RE GLMM) model.||||||0.013||||||A priori threshold for statistical significance was p\<.05.|t-test, 1 sided|||||||.013
71744303|NCT03369418|142999267|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.33
71744304|NCT02485561|142999286|SUPERIORITY||F-value|1.019||||0.362|TWO_SIDED||||||ANOVA|||||||.362
71744305|NCT02485561|142999287|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.098||0.024|TWO_SIDED||||||t-test, 2 sided|||||||.024
71744306|NCT02485561|142999287|SUPERIORITY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.074||0.75|TWO_SIDED||||||t-test, 2 sided|||||||.75
71744307|NCT02485561|142999288|SUPERIORITY||F-value|6.482||||0.002|TWO_SIDED||||||ANOVA|||||||.002
71744308|NCT02485561|142999288|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.91|TWO_SIDED||||||t-test, 2 sided|||||||.91
71834377|NCT03363854|143172625|SUPERIORITY||Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-4.3|-1.6||This secondary endpoint was tested sequentially using the Holm method for multiplicity adjustment at a 5% significance level after sequential testing of the primary endpoints and the first secondary endpoint, if these showed statistical significance.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-1.6|-4.3|<0.001
71834378|NCT03363854|143172627|SUPERIORITY||Difference|-3.5||||0.41|TWO_SIDED|95.0|-11.9|4.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||4.9|-11.9|0.41
71744309|NCT02485561|142999288|SUPERIORITY||Mean Difference (Final Values)|0.716|STANDARD_ERROR_OF_MEAN|0.182|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71744310|NCT02485561|142999289|SUPERIORITY||F-value|0.608||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
71744311|NCT02485561|142999290|SUPERIORITY||F-value|16.31|||<|0.001|TWO_SIDED||||||ANOVA|||||||<.001
71744312|NCT02485561|142999290|SUPERIORITY||F-value|2.0||||0.14|TWO_SIDED||||||ANOVA|||||||0.14
71744313|NCT02485561|142999291|SUPERIORITY||F-value|1.68||||0.19|TWO_SIDED||||||ANOVA|||||||.19
71744314|NCT02485561|142999291|SUPERIORITY||F-value|0.021||||0.98|TWO_SIDED||||||ANOVA|||||||.98
71744315|NCT02485561|142999291|SUPERIORITY||F-value|0.312||||0.73|TWO_SIDED||||||ANOVA|||||||.73
71744316|NCT02485561|142999291|SUPERIORITY||F-value|0.702||||0.496|TWO_SIDED||||||ANOVA|||||||.496
71744317|NCT02485561|142999291|SUPERIORITY||F-value|1.88||||0.154|TWO_SIDED||||||ANOVA|||||||.154
71744318|NCT02485561|142999291|SUPERIORITY||F-value|0.667||||0.514|TWO_SIDED||||||ANOVA|||||||.514
71744319|NCT02485561|142999291|SUPERIORITY||F-value|0.666||||0.514|TWO_SIDED||||||ANOVA|||||||.514
71744320|NCT02485561|142999292|SUPERIORITY||F-value|0.59||||0.56|TWO_SIDED||||||ANOVA|||||||.56
71744321|NCT02485561|142999293|SUPERIORITY||F-value|0.18||||0.84|TWO_SIDED||||||ANOVA|||||||.84
71744322|NCT02485561|142999294|SUPERIORITY||F-value|1.16||||0.31|TWO_SIDED||||||ANOVA|||||||.31
71744323|NCT02485561|142999295|SUPERIORITY||F-value|1.17||||0.31|TWO_SIDED||||||ANOVA|||||||.31
71744324|NCT02485561|142999295|SUPERIORITY||F-value|0.056||||0.95|TWO_SIDED||||||ANOVA|||||||.95
71744325|NCT01126723|142999308|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||The a priori threshold for statistical significance was set to 0.05.|Fisher Exact|||||||0.15
71744326|NCT03901144|142999315|SUPERIORITY||Mean Difference (Final Values)|-9.026|||<|0.001|TWO_SIDED|95.0|-12.562|-5.489|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.489|-12.562|<0.001
71744327|NCT03901144|142999315|SUPERIORITY||Mean Difference (Final Values)|-4.194||||0.021|TWO_SIDED|95.0|-7.76|-0.629|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-0.629|-7.760|0.021
71744328|NCT03901144|142999315|SUPERIORITY||Mean Difference (Final Values)|-9.021|||<|0.001|TWO_SIDED|95.0|-12.602|-5.44|||ANCOVA|||Summary of TEWL (g/m2h) change from day 29 to day 31||-5.440|-12.602|<0.001
71744329|NCT03901144|142999316|SUPERIORITY||Mean Difference (Final Values)|-3.538|||<|0.001|TWO_SIDED|95.0|-5.114|-1.962|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-1.962|-5.114|<0.001
71744330|NCT03901144|142999316|SUPERIORITY||Mean Difference (Final Values)|-1.748||||0.031|TWO_SIDED|95.0|-3.332|-0.164|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-0.164|-3.332|0.031
71744331|NCT03901144|142999316|SUPERIORITY||Mean Difference (Final Values)|-4.744|||<|0.001|TWO_SIDED|95.0|-6.332|-3.156|||ANCOVA|||Summary of Objective Erythema (2D Skin Imaging) change from day 29 to day 31||-3.156|-6.332|<0.001
71744332|NCT03901144|142999317|SUPERIORITY||Mean Difference (Final Values)|-19.077||||0.002|TWO_SIDED|95.0|-31.325|-6.829|||ANCOVA|||Summary of Redness-Mexameter change from day 29 to day 31||-6.829|-31.325|0.002
71744333|NCT03901144|142999317|SUPERIORITY||Mean Difference (Final Values)|-4.493||||0.471|TWO_SIDED|95.0|-16.787|7.801|||ANCOVA|||||7.801|-16.787|0.471
71744334|NCT03901144|142999317|SUPERIORITY||Mean Difference (Final Values)|-27.035|||<|0.001|TWO_SIDED|95.0|-39.372|-14.698|||ANCOVA|||Summary of Redness - Mexameter change from day 29 to day 31||-14.698|-39.372|<0.001
71744335|NCT03901144|142999319|SUPERIORITY||Mean Difference (Net)|-0.354|||<|0.001|TWO_SIDED|95.0|-0.558|-0.15|||ANCOVA|||Summary of Visual Redness at day 31||-0.150|-0.558|<0.001
71744336|NCT03901144|142999319|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.392|TWO_SIDED|95.0|-0.292|0.115|||ANCOVA|||Summary of Visual Redness at day 31||0.115|-0.292|0.392
71744337|NCT03901144|142999319|SUPERIORITY||Mean Difference (Final Values)|-0.447|||<|0.001|TWO_SIDED|95.0|-0.652|-0.242|||ANCOVA|||Summary of Visual Redness at day 31||-0.242|-0.652|<0.001
71664621|NCT01851330|142842537|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71744338|NCT00104650|142999320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.28|||<|0.001||95.0|3.35|45.03|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||45.03|3.35|<0.001
71744339|NCT00104650|142999320|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.33||||0.002||95.0|1.74|16.36|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor||||16.36|1.74|0.002
71744340|NCT00104650|142999320|SUPERIORITY_OR_OTHER||Percentage of participants|77.8||||||95.0|60.8|89.9||||||||89.9|60.8|
71744341|NCT00104650|142999320|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
71744342|NCT00104650|142999320|SUPERIORITY_OR_OTHER||Percentage of participants|28.6||||||95.0|14.6|46.3||||||||46.3|14.6|
71744343|NCT00104650|142999321|SUPERIORITY_OR_OTHER||Percentage of participants|63.9||||||95.0|46.2|79.2||||||||79.2|46.2|
71744344|NCT00104650|142999321|SUPERIORITY_OR_OTHER||Percentage of participants|63.6||||||95.0|45.1|79.6||||||||79.6|45.1|
71777833|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.08||||0.54|TWO_SIDED|||||alpha = 0.05|Interaction Term|||Regimen-Related Distress Subscale - Treatment Effect - Month 6||||0.54
71777834|NCT04041375|143054840|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.3||||0.05|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Interpersonal Distress Subscale - Treatment Effect - Month 6||||0.05
71834379|NCT03363854|143172627|SUPERIORITY||Difference|-6.9||||0.033|TWO_SIDED|95.0|-13.3|-0.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||-0.6|-13.3|0.033
71744345|NCT00104650|142999321|SUPERIORITY_OR_OTHER||Percentage of participants|37.1||||||95.0|21.5|55.1||||||||55.1|21.5|
71744346|NCT00104650|142999322|SUPERIORITY_OR_OTHER|||||||0.388|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.388
71744347|NCT00104650|142999323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.79|||<|0.001||95.0|2.01|7.15|||Regression, Cox|Stratified by cancer type and screening uNTx level||||7.15|2.01|<0.001
71744348|NCT00104650|142999323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.32|||<|0.001||95.0|2.23|8.36|||Regression, Cox|Stratified by cancer type and screening uNTx level||||8.36|2.23|<0.001
71744349|NCT00104650|142999324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.274||||0.006||95.0|0.11|0.687|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.687|0.110|0.006
71744350|NCT00104650|142999324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199||||0.001||95.0|0.076|0.523|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level||||0.523|0.076|0.001
71744351|NCT00104650|142999325|SUPERIORITY_OR_OTHER|||||||0.056|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)||||||0.056
71744352|NCT00104650|142999326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.162||||0.105||95.0|0.018|1.465|||Regression, Cox|||||1.465|0.018|0.105
71744353|NCT00104650|142999326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.43||95.0|0.143|2.289|||Regression, Cox|||||2.289|0.143|0.430
71744354|NCT00104650|142999327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26||||||95.0|0.05|1.44||||||||1.44|0.05|
71744355|NCT00104650|142999327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||||95.0|0.08|1.76||||||||1.76|0.08|
71744356|NCT04184297|142999350|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.76|0.96|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||0.96|0.76|
71744357|NCT04184297|142999351|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|This method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of a hospitalization for community-acquired pneumonia for overall population.||1.07|0.64|
71744358|NCT04184297|142999352|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19|||Regression, Cox|The method was used to calculate hazard ratios with 95% confidence intervals.|Hazard ratio of Tiotropium+Olodaterol versus LABA/LAMA/ICS.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.||1.19|0.91|
71744359|NCT02412098|142999353|OTHER||Geometric Least Square Mean (GLSM) Ratio|73.54|||||TWO_SIDED|90.0|41.92|129.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||129.01|41.92|
71744360|NCT02412098|142999353|OTHER||GLSM Ratio (%)|127.8|||||TWO_SIDED|90.0|73.57|222.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.||222.01|73.57|
71744361|NCT02412098|142999354|OTHER||GLSM Ratio (%)|80.82|||||TWO_SIDED|90.0|45.11|144.79|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.||144.79|45.11|
71834380|NCT03363854|143172627|SUPERIORITY||Difference|-4.7||||0.12|TWO_SIDED|95.0|-10.6|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||1.2|-10.6|0.12
71744362|NCT02412098|142999354|OTHER||GLSM Ratio (%)|73.52|||||TWO_SIDED|90.0|47.83|113.02||ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.|||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|||113.02|47.83|
71744363|NCT02412098|142999355|OTHER||GLSM Ratio (%)|66.55|||||TWO_SIDED|90.0|53.33|83.04|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||83.04|53.33|
71744364|NCT02412098|142999355|OTHER||GLSM Ratio (%)|102.06|||||TWO_SIDED|90.0|83.03|125.45|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.||125.45|83.03|
71744365|NCT02412098|142999356|OTHER||GLSM Ratio (%)|76.24|||||TWO_SIDED|90.0|50.65|114.77|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||114.77|50.65|
71744366|NCT02412098|142999356|OTHER||GLSM Ratio (%)|71.06|||||TWO_SIDED|90.0|44.59|113.25|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.||113.25|44.59|
71744367|NCT03089580|142999359|SUPERIORITY|Paired, Student's t-test was used to contrast the outcome variable of TBUT in the treated eye versus the sham eye from visit 1 to visit 5. The null hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error probability of 0.05 for the primary outcome assessment. The pattern of change over the 4 treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS version 9.4 statistical software (SAS Institute, Cary, NC) was used.||||||0.3|||||||paired t test|||The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 \& 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.||||0.3
71744368|NCT03089580|142999360|SUPERIORITY|The p-value results from a test of the hypothesis that the change in OSDI from visit 1 does not differ from zero. Change distributions that met normal distribution test criteria (Shapiro-Wilk p-value \>0.05) were tested with the paired Student's t-test; non-normal change distributions (at visits 2 \& 4) were tested with the non-parametric Wilcoxon signed rank test.||||||0.2026|||||||paired t test|||||||0.2026
71744369|NCT03087513|142999361|SUPERIORITY||||||<|0.01||||||In all cases of motor evoked potential changes, a P-value of 0.05 was considered significant.|Mixed Models Analysis|As the amplitude values were non-normally distributed, the Mann-Whitney U test was performed to compare the two groups.||In total, 40 patients were randomised for the study. Data from 2 patients were excluded as the crossover arm could not be completed due to intraoperative MEP change (n=1) and the equipment malfunction (n=1). The data distributions were tested for normality with the Kolmogorov-Smirnov test.||||<0.01
71744370|NCT02679287|142999414|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.0001|TWO_SIDED|95.0|1.2|2.4|||Mixed Models Analysis|||The null hypothesis is that there is no difference in percentage of time \<70 mg/dL in SAP vs. evening-overnight CLC session. Change in HbA1c during study sessions was used as a covariate of the model.||2.4|1.2|<0.0001
71744371|NCT05298202|142999488|SUPERIORITY|time x treatment ANOVA||||||0.284||||||difference between treatment and control|ANOVA|||||||0.284
71744372|NCT05298202|142999489|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||.177
71744373|NCT05298202|142999490|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||.122
71744374|NCT05298202|142999491|SUPERIORITY|||||||0.038|||||||ANOVA|time x treatment anova||||||.038
71744375|NCT05298202|142999492|SUPERIORITY|||||||0.976|||||||ANOVA|||||||.976
71744376|NCT05298202|142999493|SUPERIORITY|||||||0.747|||||||ANOVA|||||||.747
71744377|NCT01875159|142999494|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE gamma regression models|||\>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour \<90% oxygen saturation/hour of recording||||<0.05
71744378|NCT01389882|142999513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.007|STANDARD_DEVIATION|2.015||0.043|TWO_SIDED|95.0|0.036|1.978|||Paired t-test|||||1.978|0.036|0.043
71744379|NCT01389882|142999514|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.232|STANDARD_DEVIATION|0.841||0.245|TWO_SIDED|95.0|-0.637|0.174|||Paired t-test|||||0.174|-0.637|0.245
71744380|NCT01389882|142999515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_DEVIATION|0.095||0.257|TWO_SIDED|95.0|-0.02|0.714|||Paired t-test|||||0.714|-0.020|0.257
71744381|NCT01389882|142999516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_DEVIATION|1.541||0.601|TWO_SIDED|95.0|-0.554|0.931|||Paired t-test|||||0.931|-0.554|0.601
71744382|NCT01389882|142999517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_DEVIATION|0.355||0.085|TWO_SIDED|95.0|-0.32|0.023|||Paired t-test|||||0.023|-0.320|0.085
71744383|NCT01389882|142999518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.516|STANDARD_DEVIATION|9.786||0.002|TWO_SIDED|95.0|1.799|11.232|||Wilcoxon signed-rank test|||||11.232|1.799|0.002
71744384|NCT01389882|142999519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|2.516||0.009|TWO_SIDED|95.0|0.478|2.904|||Paired t-test, 2-sided|||||2.904|0.478|0.009
71744385|NCT01389882|142999520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.692|STANDARD_DEVIATION|2.192||0.314|TWO_SIDED|95.0|-0.364|1.749|||Wilcoxon signed-rank test|||||1.749|-0.364|0.314
71744386|NCT01389882|142999521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_DEVIATION|0.047||0.515|TWO_SIDED|95.0|-0.03|0.016|||Paired t-test|||||0.016|-0.030|0.515
71744387|NCT01389882|142999522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1105|STANDARD_DEVIATION|7.501||0.949|TWO_SIDED|95.0|-3.505|3.726|||Paired t-test|||||3.726|-3.505|0.949
71744388|NCT01389882|142999523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_DEVIATION|12.081||0.709|TWO_SIDED|95.0|-4.77|6.875|||Paired t-test|||||6.875|-4.770|0.709
71744389|NCT01389882|142999524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.274|STANDARD_DEVIATION|2.233||0.6|TWO_SIDED|95.0|-1.35|0.802|||Paired t-test|||||0.802|-1.350|0.600
71744390|NCT01116401|142999546|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||||||0.007
71777835|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.58||||0.03|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 3||||0.03
71777836|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.07||||0.83|TWO_SIDED||||||Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 3||||0.83
71744391|NCT01116401|142999547|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||||||<0.01
71744392|NCT00669214|142999593|SUPERIORITY_OR_OTHER||Difference in proportion|0.163||||0.1054||95.0|-0.063|0.393|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.393|-0.063|0.1054
71777837|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.44||||0.12|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 3||||0.12
71777838|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.39||||0.17|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 3||||0.17
71777839|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.85|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 3||||0.85
71777840|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.02||||0.94|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 3||||0.94
71777841|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.47|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||General Diet - Treatment Effect - Month 6||||0.47
71777842|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.08||||0.82|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fruits and Vegetables) - Treatment Effect - Month 6||||0.82
71777843|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.13||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Specific Diet (Fat) - Treatment Effect - Month 6||||0.66
71777844|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.25||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Physical Activity - Treatment Effect - Month 6||||0.38
71834381|NCT03363854|143172627|SUPERIORITY||Difference|-7.3||||0.043|TWO_SIDED|95.0|-14.3|-0.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||-0.2|-14.3|0.043
71744393|NCT00669214|142999595|SUPERIORITY_OR_OTHER||Difference in proportion|0.155||||0.2404||95.0|-0.072|0.388|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.388|-0.072|0.2404
71744394|NCT00669214|142999597|SUPERIORITY_OR_OTHER||Difference in proportion|0.228||||0.0366||95.0|0.003|0.452|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.||||0.452|0.003|0.0366
71744395|NCT00669214|142999599|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|3.33||||0.1816||95.0|-2.811|9.471|||Student T-test|||||9.471|-2.811|0.1816
71744396|NCT00669214|142999601|SUPERIORITY_OR_OTHER||Difference in mean change from Day 0|1.19||||0.0435||95.0|-0.161|2.532|||Student T-test|||||2.532|-0.161|0.0435
71744397|NCT00669214|142999603|SUPERIORITY_OR_OTHER|||||||0.0224||95.0|||||Wilcoxon rank sum|||||||0.0224
71744398|NCT00754377|142999606|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71744399|NCT00754377|142999607|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71744400|NCT01276639|142999608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.46|||<|0.0001|TWO_SIDED|95.0|4.4|15.03||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||15.03|4.40|<0.0001
71744401|NCT01276639|142999608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.45|||<|0.0001|TWO_SIDED|95.0|9.01|31.88||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||31.88|9.01|<0.0001
71777845|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.12||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Blood Glucose Testing - Treatment Effect - Month 6||||0.68
71777846|NCT04041375|143054841|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.26||||0.4|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Foot Care - Treatment Effect - Month 6||||0.40
71834382|NCT03363854|143172627|SUPERIORITY||Difference|-9.1||||0.002|TWO_SIDED|95.0|-14.8|-3.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||-3.4|-14.8|0.002
71834383|NCT03363854|143172627|SUPERIORITY||Difference|-8.0||||0.001|TWO_SIDED|95.0|-12.8|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||-3.2|-12.8|0.001
71744402|NCT01276639|142999608|SUPERIORITY_OR_OTHER||Percent difference|17.29|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|10.11|24.47|||Normal approximation|||||24.47|10.11|<0.0001
71744403|NCT01276639|142999609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.93|||<|0.0001|TWO_SIDED|95.0|5.25|21.84||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||21.84|5.25|<0.0001
71834384|NCT03363854|143172627|SUPERIORITY||Difference|-10.2|||<|0.001|TWO_SIDED|95.0|-15.8|-4.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-4.7|-15.8|<0.001
71834385|NCT03363854|143172627|SUPERIORITY||Difference|-8.6||||0.002|TWO_SIDED|95.0|-14.1|-3.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-3.2|-14.1|0.002
71834386|NCT03363854|143172628|SUPERIORITY||Difference|0.0||||1|TWO_SIDED|95.0|-11.0|11.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1-2 are reported below.||11.0|-11.0|1.00
71744404|NCT01276639|142999609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.81|||<|0.0001|TWO_SIDED|95.0|11.9|49.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||49.86|11.90|<0.0001
71744405|NCT01276639|142999609|SUPERIORITY_OR_OTHER||Percent difference|19.22|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|12.07|26.37|||Normal approximation|||||26.37|12.07|<0.0001
71744406|NCT01276639|142999610|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-53.56|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-62.08|-45.04||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-45.04|-62.08|<0.0001
71744407|NCT01276639|142999610|SUPERIORITY_OR_OTHER||LS mean difference|-68.82|STANDARD_ERROR_OF_MEAN|4.34|<|0.0001|TWO_SIDED|95.0|-77.33|-60.31||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-60.31|-77.33|<0.0001
71744408|NCT01276639|142999610|SUPERIORITY_OR_OTHER||LS mean difference|-15.26|STANDARD_ERROR_OF_MEAN|3.46|<|0.0001|TWO_SIDED|95.0|-22.04|-8.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-8.48|-22.04|<0.0001
71744409|NCT01276639|142999611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.55|||<|0.0001|TWO_SIDED|95.0|7.46|1786.9||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||1786.9|7.46|<0.0001
71744410|NCT01276639|142999611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|98.05|||<|0.0001|TWO_SIDED|95.0|23.49|5689.8||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||5689.8|23.49|<0.0001
71744411|NCT01276639|142999611|SUPERIORITY_OR_OTHER||Percent difference|19.61|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|13.1|26.11|||Normal approximation|||||26.11|13.10|<0.0001
71777847|NCT04041375|143054843|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.06||||0.93|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.93
71777848|NCT04041375|143054843|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.63||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.38
71777849|NCT04041375|143054844|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.32||||0.66|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.66
71777850|NCT04041375|143054844|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.99||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
71777851|NCT04041375|143054847|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.45||||0.38|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.38
71744412|NCT01276639|142999613|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-4.75|-3.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.05|-4.75|<0.0001
71744413|NCT01276639|142999613|SUPERIORITY_OR_OTHER||LS mean difference|-4.71|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-5.56|-3.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.86|-5.56|<0.0001
71744414|NCT01276639|142999613|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.35||0.0212|TWO_SIDED|95.0|-1.5|-0.12|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.12|-1.50|0.0212
71744415|NCT01276639|142999613|SUPERIORITY_OR_OTHER||LS mean difference|-4.98|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-6.02|-3.95||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.95|-6.02|<0.0001
71744416|NCT01276639|142999613|SUPERIORITY_OR_OTHER||LS mean difference|-6.97|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-8.0|-5.94||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.94|-8.00|<0.0001
71744417|NCT01276639|142999613|SUPERIORITY_OR_OTHER||LS mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.8|-1.17|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.17|-2.80|<0.0001
71744418|NCT01276639|142999614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.34|||<|0.0001|TWO_SIDED|95.0|3.23|35.12||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.12|3.23|<0.0001
71744419|NCT01276639|142999614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53|||<|0.0001|TWO_SIDED|95.0|5.06|54.42||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||54.42|5.06|<0.0001
71744420|NCT01276639|142999614|SUPERIORITY_OR_OTHER||Percent difference|5.98|STANDARD_ERROR_OF_MEAN|2.97||0.0443|TWO_SIDED|95.0|0.15|11.8|||Normal approximation|||||11.80|0.15|0.0443
71777852|NCT04041375|143054847|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|1.64||||0.68|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.68
71834387|NCT03363854|143172628|SUPERIORITY||Difference|1.1||||0.83|TWO_SIDED|95.0|-9.1|11.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3-4 are reported below.||11.4|-9.1|0.83
71834388|NCT03363854|143172628|SUPERIORITY||Difference|-1.4||||0.78|TWO_SIDED|95.0|-11.3|8.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5-6 are reported below.||8.5|-11.3|0.78
71744421|NCT01276639|142999615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.76||||0.0003|TWO_SIDED|95.0|2.11|35.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||35.77|2.11|0.0003
71744422|NCT01276639|142999615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.64|59.98||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||59.98|3.64|<0.0001
71744423|NCT01276639|142999615|SUPERIORITY_OR_OTHER||Percent difference|5.09|STANDARD_ERROR_OF_MEAN|2.5||0.0415|TWO_SIDED|95.0|0.19|9.98|||Normal approximation|||||9.98|0.19|0.0415
71744424|NCT01276639|142999616|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|17.6|<|0.0001|TWO_SIDED|95.0|-104.27|-35.13||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-35.13|-104.27|<0.0001
71744425|NCT01276639|142999616|SUPERIORITY_OR_OTHER||LS mean difference|-97.03|STANDARD_ERROR_OF_MEAN|17.47|<|0.0001|TWO_SIDED|95.0|-131.35|-62.72||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-62.72|-131.35|<0.0001
71744426|NCT01276639|142999616|SUPERIORITY_OR_OTHER||LS mean difference|-27.33|STANDARD_ERROR_OF_MEAN|13.22||0.0391|TWO_SIDED|95.0|-53.29|-1.37|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-1.37|-53.29|0.0391
71744427|NCT01276639|142999620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744428|NCT01276639|142999620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744429|NCT01276639|142999620|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744430|NCT01276639|142999621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744431|NCT01276639|142999621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744432|NCT01276639|142999621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744433|NCT01276639|142999622|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744434|NCT01276639|142999622|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744435|NCT01276639|142999622|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71744436|NCT00896298|142999676|SUPERIORITY|||||||0.2572|||||||Mixed Models Analysis|||||||0.2572
71744437|NCT00896298|142999677|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||||||0.71
71744438|NCT00896298|142999678|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.68
71744439|NCT00896298|142999679|SUPERIORITY|||||||0.0256|||||||Mixed Models Analysis|||||||0.0256
71744440|NCT02660853|142999680|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Baseline versus during exacerbation.||||0.745
71744441|NCT02660853|142999684|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
71744442|NCT00796666|142999709|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8616||||0.5416|TWO_SIDED|95.0|0.602|1.233|||Log Rank|||||1.233|0.602|0.5416
71744443|NCT00796666|142999710|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||P-value was based on the analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO Functional Class (FC) as fixed effects and baseline 6 Minute Walk Distance (6MWD) as a covariate.|ANCOVA|||Baseline to Week 12||||0.0049
71744444|NCT00796666|142999711|SUPERIORITY_OR_OTHER|||||||0.8223|TWO_SIDED|||||Missing values at Week 12 and Week 24 were imputed with the last non-missing WHO FC based on the last observation carried forward (LOCF) method.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test used modified ridit scores and the p-value corresponding to the ANCOVA (row mean scores) statistic was reported.||Baseline to Week 12||||0.8223
71744445|NCT00796666|142999712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-3.13|1.2|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||1.20|-3.13|
71744446|NCT00796666|142999712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|0.31|4.36|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12||4.36|0.31|
71744447|NCT00796666|142999712|SUPERIORITY_OR_OTHER|||||||0.0094|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0094
71744448|NCT00796666|142999713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|-3.92|1.2|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||1.20|-3.92|
71744449|NCT00796666|142999713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-0.38|4.35|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12||4.35|-0.38|
71744450|NCT00796666|142999713|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0244
71744451|NCT00796666|142999714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-3.78|2.04|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||2.04|-3.78|
71744452|NCT00796666|142999714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-0.41|4.9|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12||4.90|-0.41|
71744453|NCT00796666|142999714|SUPERIORITY_OR_OTHER|||||||0.0624|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0624
71744454|NCT00796666|142999715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-2.57|2.06|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FCvas fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||2.06|-2.57|
71834389|NCT03363854|143172628|SUPERIORITY||Difference|-4.8||||0.34|TWO_SIDED|95.0|-14.8|5.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7-8 are reported below.||5.1|-14.8|0.34
71834390|NCT03363854|143172628|SUPERIORITY||Difference|-4.4||||0.34|TWO_SIDED|95.0|-13.4|4.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9-10 are reported below.||4.6|-13.4|0.34
71834391|NCT03363854|143172628|SUPERIORITY||Difference|-6.2||||0.11|TWO_SIDED|95.0|-13.9|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11-12 are reported below.||1.5|-13.9|0.11
71744455|NCT00796666|142999715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|0.48|4.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12||4.82|0.48|
71744456|NCT00796666|142999715|SUPERIORITY_OR_OTHER|||||||0.0324|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0324
71744457|NCT00796666|142999716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-2.1|2.97|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||2.97|-2.10|
71744458|NCT00796666|142999716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|1.74|6.45|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12||6.45|1.74|
71744459|NCT00796666|142999716|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0136
71744460|NCT00796666|142999717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-2.33|3.23|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||3.23|-2.33|
71834392|NCT03363854|143172628|SUPERIORITY||Difference|-8.9||||0.024|TWO_SIDED|95.0|-16.6|-1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13-14 are reported below.||-1.2|-16.6|0.024
71744461|NCT00796666|142999717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.73|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|0.14|5.32|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12||5.32|0.14|
71744462|NCT00796666|142999717|SUPERIORITY_OR_OTHER|||||||0.1582|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.1582
71744463|NCT00796666|142999718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|-3.09|3.18|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||3.18|-3.09|
71744464|NCT00796666|142999718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-0.62|5.16|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12||5.16|-0.62|
71744465|NCT00796666|142999718|SUPERIORITY_OR_OTHER|||||||0.2161|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2161
71744466|NCT00796666|142999719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|-1.61|4.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||4.50|-1.61|
71744467|NCT00796666|142999719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.82|6.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12||6.50|0.82|
71744468|NCT00796666|142999719|SUPERIORITY_OR_OTHER|||||||0.2087|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2087
71744469|NCT00796666|142999720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|-1.21|3.58|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||3.58|-1.21|
71744470|NCT00796666|142999720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.71|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|0.37|5.05|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12||5.05|0.37|
71664622|NCT01851330|142842537|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.|Difference in proportions|-3.2|||||TWO_SIDED|97.5|-8.3|1.8|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||1.8|-8.3|
71744471|NCT00796666|142999720|SUPERIORITY_OR_OTHER|||||||0.2897|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.2897
71744472|NCT00796666|142999721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.05|1.38|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||1.38|-2.05|
71744473|NCT00796666|142999721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|0.46|3.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12||3.82|0.46|
71744474|NCT00796666|142999721|SUPERIORITY_OR_OTHER|||||||0.0179|TWO_SIDED|||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|ANCOVA|||Baseline to Week 12||||0.0179
71744475|NCT01521507|142999740|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|z-statistic|p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.||||<0.0001
71744476|NCT01521507|142999740|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0020
71834393|NCT03363854|143172628|SUPERIORITY||Difference|-9.5||||0.017|TWO_SIDED|95.0|-17.3|-1.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15-16 are reported below.||-1.7|-17.3|0.017
71664623|NCT01851330|142842537|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|-2.3|||||TWO_SIDED|97.5|-7.2|2.5|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||2.5|-7.2|
71664624|NCT01851330|142842537|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||5.7|-3.9|
71664625|NCT02667067|142842551|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71664626|NCT02368314|142842567|SUPERIORITY_OR_OTHER|||||||0.226|||||||Fisher Exact|||||||0.226
71664627|NCT01333397|142842619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 20 U Vs Placebo||||<0.0001
71744477|NCT01521507|142999741|SUPERIORITY_OR_OTHER|||||||0.9098|TWO_SIDED||||||Mixed Models Analysis|Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.||The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.9098
71744478|NCT01521507|142999742|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED|||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|t-test, 2 sided|||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt \> µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.||||0.0068
71744479|NCT01521507|142999742|SUPERIORITY_OR_OTHER|||||||0.0419|TWO_SIDED||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.||||0.0419
71744480|NCT01521507|142999743|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED|||||Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.|Mixed Models Analysis|||The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.||||0.0237
71744481|NCT01290614|142999856|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||t-test, 2 sided|||||||0.57
71744482|NCT01290614|142999857|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71744483|NCT01825187|142999884|SUPERIORITY|||||||0.523|||||||t-test, 1 sided|||||||0.523
71834394|NCT03363854|143172630|SUPERIORITY||Difference|0.1||||0.64|TWO_SIDED|95.0|-0.5|0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 1 are reported below.||0.7|-0.5|0.64
71744484|NCT01825187|142999885|SUPERIORITY|||||||0.371|||||||t-test, 1 sided|||Nasa Mental Demand||||0.371
71664628|NCT01333397|142842619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 50 U Vs Placebo||||<0.0001
71664629|NCT01333397|142842619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||ILA - Dysport NG 75 U Vs Placebo||||<0.0001
71664630|NCT01333397|142842619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 20 U Vs Placebo||||<0.0001
71664631|NCT01333397|142842619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 50 U Vs Placebo||||<0.0001
71664632|NCT01333397|142842619|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||SSA - Dysport NG 75 U Vs Placebo||||<0.0001
71664633|NCT04411914|142842684|SUPERIORITY|||||||0.0009|||||||Spearman Correlation Coefficient|||||||0.0009
71664634|NCT04411914|142842685|OTHER|||||||0.0053|||||||Spearman Correlation Coefficient|"Spearman Correlation Coefficient, N=9 Prob \> \|r\| under H0: Rho=0"||||||0.0053
71664635|NCT01778634|142842689|SUPERIORITY||Odds Ratio (OR)|7.51|||<|0.0001|TWO_SIDED|95.0|2.53|22.27|||Cochran-Mantel-Haenszel|||||22.27|2.53|<0.0001
71664636|NCT01778634|142842690|SUPERIORITY||Risk Difference (RD)|0.11||||0.28|TWO_SIDED|95.0|-0.08|0.29|||Generalized Estimating Equations||Generalized Estimating Equations with an identity link|||0.29|-0.08|0.28
71664637|NCT01778634|142842691|SUPERIORITY|P values are based on GEE to account for twins||||||0.11|||||||GEE|||||||0.11
71664638|NCT01778634|142842692|SUPERIORITY|P values are based on GEE to account for twins. The counts provided refer to to the numbers actually observed. The analysis to determine the p value accounted for the missing 11 patients using multiple imputation.||||||0.62|||||||GEE with multiple imputation|||||||0.62
71664639|NCT01778634|142842693|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71664640|NCT01778634|142842694|SUPERIORITY|||||||0.88||||||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon (Mann-Whitney)|||||||0.88
71664641|NCT01778634|142842695|SUPERIORITY||Median Difference (Final Values)|5.0||||0.94|TWO_SIDED|95.0|-15.0|26.0||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon test after multiple outputation||Bootstrap|||26|-15|0.94
71664642|NCT01778634|142842696|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71664643|NCT01778634|142842697|SUPERIORITY||Odds Ratio (OR)|1.07||||0.88|TWO_SIDED|95.0|0.44|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.44|0.88
71744485|NCT01825187|142999885|SUPERIORITY|||||||0.122|||||||t-test, 1 sided|||NASA Physical Demand||||0.122
71744486|NCT01825187|142999885|SUPERIORITY|||||||0.325|||||||t-test, 1 sided|||NASA Temporal Demand||||0.325
71744487|NCT01825187|142999885|SUPERIORITY|||||||0.0451|||||||t-test, 1 sided|||NASA Peformance||||0.0451
71744488|NCT01292187|142999886|SUPERIORITY_OR_OTHER|||||||0.0265|||||||Mixed Models Analysis|||||||0.0265
71744489|NCT01292187|142999887|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||0.0340
71777853|NCT04041375|143054848|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.19||||0.74|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.74
71744490|NCT02109640|142999921|SUPERIORITY_OR_OTHER||Absolute percentage difference|17.1||||0.264|TWO_SIDED|95.0|-10.0|40.7||Absolute % difference 17.1 (95% CI -10.0,40.7)|Fisher Exact|||||40.7|-10.0|0.264
71777854|NCT04041375|143054848|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.29||||0.62|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.62
71744491|NCT02109640|142999922|SUPERIORITY_OR_OTHER|||||||0.222|||||||t-test, 2 sided|||||||0.222
71744492|NCT02109640|142999923|SUPERIORITY_OR_OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
71744493|NCT01363700|142999924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.11|||t-test, 2 sided|||||-1.11|-1.52|<0.001
71777855|NCT04041375|143054849|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.16||||0.72|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.72
71664644|NCT01778634|142842698|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
71664645|NCT01778634|142842700|SUPERIORITY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71744494|NCT01363700|142999925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.71|-0.92|||t-test, 2 sided|||||-0.92|-1.71|<0.001
71664646|NCT01778634|142842701|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71664647|NCT01778634|142842702|SUPERIORITY|||||||0.18|||||||Generalized Estimating Equations|||||||0.18
71744495|NCT01363700|142999926|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular itching score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.21|0.08||||||||0.08|-0.21|
71744496|NCT01363700|142999927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in Mean Ocular hyperemia score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.81|0.22||||||||0.22|-0.81|
71744497|NCT02230566|142999928|SUPERIORITY||LS Mean|-64.82|||<|0.0001|TWO_SIDED|95.0|-69.66|-59.98||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||-59.98|-69.66|< 0.0001
71744498|NCT02230566|142999929|SUPERIORITY|||||||0.0527|||||||t-test|"P value from t-test of no change (0 change) from baseline"||||||0.0527
71744499|NCT02230566|142999930|SUPERIORITY||LS Mean|20.8||||0.2137|TWO_SIDED|95.0|-12.0|53.7||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE|||||53.7|-12.0|0.2137
71744500|NCT02230566|142999933|SUPERIORITY||LS Mean|-6.5||||0.1778|TWO_SIDED|95.0|-16.1|3.0|||GEE|||Shoulder Flexion - Left||3.0|-16.1|0.1778
71744501|NCT02230566|142999933|SUPERIORITY||LS Mean|-1.5||||0.7632|TWO_SIDED|95.0|-10.9|8.0|||GEE|||Shoulder Extension - Left||8.0|-10.9|0.7632
71744502|NCT02230566|142999933|SUPERIORITY||LS Mean|-1.8||||0.6034|TWO_SIDED|95.0|-8.8|5.1|||GEE|||Shoulder Flexion - Right||5.1|-8.8|0.6034
71744503|NCT02230566|142999933|SUPERIORITY||LS Mean|-3.4||||0.3332|TWO_SIDED|95.0|-10.2|3.4|||GEE|||Shoulder Extension - Right||3.4|-10.2|0.3332
71744504|NCT02230566|142999933|SUPERIORITY||LS Mean|-9.4||||0.0415|TWO_SIDED|95.0|-18.4|-0.4|||GEE|||Tighter Shoulder Flexion||-0.4|-18.4|0.0415
71744505|NCT02230566|142999933|SUPERIORITY||LS Mean|-6.7||||0.0563|TWO_SIDED|95.0|-13.6|0.2|||GEE|||Tighter Shoulder Extension||0.2|-13.6|0.0563
71744506|NCT02230566|142999934|SUPERIORITY||LS Mean|1.0||||0.114|TWO_SIDED|95.0|-0.2|2.2|||GEE|||for the left eye||2.2|-0.2|0.1140
71744507|NCT02230566|142999934|SUPERIORITY||LS Mean|0.9||||0.0906|TWO_SIDED|95.0|-0.1|1.8|||GEE|||for the right eye||1.8|-0.1|0.0906
71744508|NCT02230566|142999935|SUPERIORITY||LS Mean|0.8||||0.0883|TWO_SIDED|95.0|-0.1|1.7|||GEE|||Scale-BALANCE||1.7|-0.1|0.0883
71744509|NCT02230566|142999935|SUPERIORITY||LS Mean|-0.2||||0.3528|TWO_SIDED|95.0|-0.7|0.2|||GEE|||Scale: FINE MOTOR PRECISION||0.2|-0.7|0.3528
71744510|NCT02230566|142999935|SUPERIORITY||LS Mean|0.2||||0.4094|TWO_SIDED|95.0|-0.2|0.6|||GEE|||Scale-MANUAL DEXTERITY||0.6|-0.2|0.4094
71744511|NCT02230566|142999935|SUPERIORITY||LS Mean|0.2||||0.102|TWO_SIDED|95.0|0.0|0.4|||GEE|||Scale-RUNNING SPEED AND AGILITY||0.4|0.0|0.1020
71744512|NCT02230566|142999936|SUPERIORITY||LS Mean|3.4||||0.1953|TWO_SIDED|95.0|-1.8|8.6|||GEE|||||8.6|-1.8|0.1953
71664648|NCT01778634|142842703|SUPERIORITY|||||||0.091|||||||Fisher Exact|||||||0.091
71664649|NCT01778634|142842704|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71664650|NCT01778634|142842705|SUPERIORITY|||||||0.33|||||||Generalized Estimating Equations|||||||0.33
71744513|NCT02230566|142999938|SUPERIORITY||LS Mean|-1.2||||0.2022|TWO_SIDED|95.0|-3.0|0.6|||GEE|||||0.6|-3.0|0.2022
71664651|NCT01778634|142842706|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71744514|NCT03507036|142999955|OTHER||||||||||||||||||A paired t-test was performed for skin lab measurement and biopsies.|||
71744515|NCT00113841|142999956|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
71744516|NCT00430716|142999981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|24.15||||0.011|ONE_SIDED|97.5|3.37||||ANOVA|||An analysis of variance (ANOVA) model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||3.37|0.011
71744517|NCT00430716|142999981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17||||0.545|ONE_SIDED|97.5|-21.48||||ANOVA|||ANOVA model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% lower confidence limit for the difference was presented.|||-21.48|0.545
71744518|NCT00430716|142999982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.51||||0.278|TWO_SIDED|95.0|-7.07|2.05|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used Analysis of Covariance (ANCOVA), with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||2.05|-7.07|0.278
71744519|NCT00430716|142999982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||0.846|TWO_SIDED|95.0|-4.98|4.09|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used ANCOVA, with etiology and baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||4.09|-4.98|0.846
71744520|NCT00430716|142999984|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.448|TWO_SIDED|95.0|0.5|4.78|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||4.78|0.50|0.448
71744521|NCT00430716|142999984|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.897|TWO_SIDED|95.0|0.35|3.32|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.||3.32|0.35|0.897
71744522|NCT00430716|142999985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-104.8||||0.005|TWO_SIDED|95.0|-177.44|-32.16|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-32.16|-177.44|0.005
71834395|NCT03363854|143172630|SUPERIORITY||Difference|0.4||||0.26|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 2 are reported below.||1.0|-0.3|0.26
71664652|NCT00351533|142842754|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.37
71664653|NCT00351533|142842755|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
71664654|NCT00351533|142842756|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.16
71664655|NCT00351533|142842757|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
71664656|NCT00351533|142842758|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
71664657|NCT00351533|142842759|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||t-test, 2 sided|||||||0.26
71664658|NCT00351533|142842760|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
71664659|NCT00351533|142842761|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
71664660|NCT00351533|142842762|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71664661|NCT00351533|142842763|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
71664662|NCT00351533|142842764|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.20
71664663|NCT00351533|142842765|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
71664664|NCT00351533|142842766|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
71664665|NCT00351533|142842767|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
71664666|NCT00351533|142842768|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||t-test, 2 sided|||||||0.66
71664667|NCT00351533|142842769|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||||||0.27
71664668|NCT00351533|142842770|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
71664669|NCT00351533|142842771|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Chi-squared|||||||0.49
71664670|NCT00351533|142842772|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
71664671|NCT00351533|142842773|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.38
71664672|NCT00351533|142842774|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71664673|NCT00351533|142842775|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
71777856|NCT04041375|143054849|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|-0.24||||0.58|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.58
71777857|NCT04041375|143054850|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.36||||0.5|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 3||||0.50
71777858|NCT04041375|143054850|SUPERIORITY|Treatment effect was modeled via multilevel linear regression with random intercepts for participants. Outcome was regressed on dummy coded categorical indicators of study arm (usual care reference), time point (baseline reference), and arm x time point interaction. Test of the arm x time interaction terms were used to assess treatment effects at months 3 and 6. Models conditioned on race, education, and income as specified a priori.|Interaction Term|0.72||||0.18|TWO_SIDED|||||alpha = 0.05|Mixed Models Analysis|||Treatment Effect - Month 6||||0.18
71777859|NCT01967342|143054859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.268|STANDARD_ERROR_OF_MEAN|-0.193||0.165|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.||||.165
71777860|NCT01967342|143054859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245|STANDARD_ERROR_OF_MEAN|0.198||0.216|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.||||.216
71777861|NCT01967342|143054859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.052|STANDARD_ERROR_OF_MEAN|0.189|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.||||< .001
71777862|NCT01967342|143054859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.361|STANDARD_ERROR_OF_MEAN|0.199||0.07|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.||||.070
71777863|NCT01967342|143054859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.823|STANDARD_ERROR_OF_MEAN|0.191|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
71777864|NCT01967342|143054859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.203||0.519|TWO_SIDED||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.||||.519
71834396|NCT03363854|143172630|SUPERIORITY||Difference|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 3 are reported below.||0.8|-0.4|0.46
71744523|NCT00430716|142999985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.0||||0.496|TWO_SIDED|95.0|-97.5|47.5|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||47.50|-97.50|0.496
71744524|NCT00430716|142999986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-462.12||||0.009|TWO_SIDED|95.0|-807.53|-116.71|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||-116.71|-807.53|0.009
71777865|NCT01967342|143054860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.247||0.196|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.||||.196
71777866|NCT01967342|143054860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.182|STANDARD_ERROR_OF_MEAN|0.239||0.447|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.||||.447
71777867|NCT01967342|143054860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.643|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||<.001
71777868|NCT01967342|143054860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.548|STANDARD_ERROR_OF_MEAN|0.237||0.021|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.||||.021
71777869|NCT01967342|143054860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.999|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
71664674|NCT00351533|142842776|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71664675|NCT00351533|142842777|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.71
71664676|NCT00351533|142842778|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
71664677|NCT00351533|142842779|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
71664678|NCT00351533|142842780|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.89
71664679|NCT00351533|142842781|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.34
71664680|NCT00602641|142842893|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.|Hazard Ratio (HR)|0.84|||||TWO_SIDED|90.0|0.67|1.045|||||Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.|Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.||1.045|0.67|
71664681|NCT00602641|142842894|SUPERIORITY_OR_OTHER_LEGACY|||||||0.476|TWO_SIDED||||||Log Rank|Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (\< 65y vs. ≥ 65y).||||||0.476
71664682|NCT00602641|142842895|SUPERIORITY_OR_OTHER_LEGACY|||||||0.204|TWO_SIDED||||||Fisher Exact|||||||0.204
71664683|NCT00602641|142842896|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71664684|NCT00070499|142842911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0|||||Fisher Exact|||||||0.073
71664685|NCT00070499|142842911|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Fisher Exact|||||||0.31
71664686|NCT00070499|142842913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of overall survival||||0.29
71744525|NCT00430716|142999986|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-141.45||||0.414|TWO_SIDED|95.0|-483.48|200.58|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||200.58|-483.48|0.414
71744526|NCT00430716|142999987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.89|TWO_SIDED|95.0|-0.17|0.15|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.||0.15|-0.17|0.890
71744527|NCT00430716|142999987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||ANCOVA|||ANCOVA method was used with etiology, baseline walking distance category (\<325m or \>=325m) and baseline score as the covariates. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (5 mg) was presented along with the p-value for the test.||0.04|-0.29|0.124
71744528|NCT00430716|142999988|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|0.0||||0.382|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||0.00|-1.00|0.382
71744529|NCT00430716|142999988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.141|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.||1.00|0.00|0.141
71744530|NCT00773513|142999992|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025.|Hazard Ratio (HR)|1.03||||0.0039|TWO_SIDED|95.0|0.93|1.15|||Regression, Cox||The pre-specified upper non-inferiority limit was 95% CI \<1.20.|||1.15|0.93|0.0039
71744531|NCT00773513|142999993|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|1.06||||0.0166|TWO_SIDED|95.0|0.94|1.19|||Regression, Cox|||||1.19|0.94|0.0166
71744532|NCT00773513|142999994|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.95||||0.0219|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox|||||1.19|0.76|0.0219
71664687|NCT00070499|142842913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Log Rank|||Log-rank test of overall survival||||0.55
71664688|NCT00070499|142842914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.074
71664689|NCT00070499|142842914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0|||||Log Rank|||Log-rank test of relapse-free survival||||0.29
71664690|NCT01371747|142842967|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664691|NCT01371747|142842967|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664692|NCT01371747|142842967|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664693|NCT01371747|142842967|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664694|NCT01371747|142842967|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664695|NCT01371747|142842967|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664696|NCT01371747|142842968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664697|NCT01371747|142842968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71744533|NCT00773513|142999995|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.94||||0.0459|TWO_SIDED|95.0|0.7|1.25|||Regression, Cox|||||1.25|0.70|0.0459
71744534|NCT00773513|142999996|NON_INFERIORITY|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.91||||0.0048|TWO_SIDED|95.0|0.74|1.12|||Regression, Cox|||||1.12|0.74|0.0048
71744535|NCT03890588|143000000|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|95.0|0.91|1.51|||Mixed Models Analysis|||||1.51|.91|.21
71744536|NCT03890588|143000001|SUPERIORITY||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.11||0.61|TWO_SIDED|95.0|0.76|1.18|||Mixed Models Analysis|||||1.18|.76|.61
71744537|NCT03890588|143000002|SUPERIORITY||Risk Ratio (RR)|0.98|STANDARD_ERROR_OF_MEAN|0.08||0.84|TWO_SIDED|95.0|0.84|1.15|||Mixed Models Analysis|||||1.15|0.84|.84
71834397|NCT03363854|143172630|SUPERIORITY||Difference|0.4||||0.16|TWO_SIDED|95.0|-0.2|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 4 are reported below.||1.0|-0.2|0.16
71744538|NCT03890588|143000003|SUPERIORITY||Risk Ratio (RR)|1.0|STANDARD_ERROR_OF_MEAN|0.11||0.99|TWO_SIDED|95.0|0.8|1.24|||Mixed Models Analysis|||||1.24|.8|.99
71744539|NCT03890588|143000004|SUPERIORITY||Risk Ratio (RR)|1.02|STANDARD_ERROR_OF_MEAN|0.12||0.86|TWO_SIDED|95.0|0.79|1.32|||Mixed Models Analysis|||||1.32|.79|.86
71744540|NCT01712204|143000018|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|STANDARD_ERROR_OF_MEAN|0.113||0.1356|TWO_SIDED|95.0|0.62|1.07|||Possion regression|||||1.07|0.62|0.1356
71664698|NCT01371747|142842968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664699|NCT01371747|142842968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71744541|NCT02781610|143000028|NON_INFERIORITY|The non-inferiority margin is -3.5%.|Mean Difference (Final Values)|-0.7||||0.0164|TWO_SIDED|95.0|-3.3|2.0|||ANOVA|Adjusted for four dichotomous randomization strata.||The ERR non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population for 93% power assuming 2-sided alpha=0.05 with 155 PP participants per arm. Difference between ERR treatment duration arms is ERR-10 - ERR-14.||2.0|-3.3|0.0164
71744542|NCT02781610|143000029|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.568|TWO_SIDED|95.0|-1.3|1.1|||ANOVA|Adjusted for four dichotomous randomization strata.||The NERR superiority test was a priori designed to be conducted on the Intent-to-Treat (ITT) population for 91% power to detect a 2.5% difference, assuming 2-sided alpha=0.05 with 285 ITT participants per arm. Difference between NERR treatment duration arms is NERR-21 - NERR-14.||1.1|-1.3|0.568
71744543|NCT02781610|143000030|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.546|TWO_SIDED|95.0|-2.4|4.6|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||4.6|-2.4|0.546
71744544|NCT02781610|143000031|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.14|TWO_SIDED|95.0|-3.7|0.5|||t-test, 2 sided|||Difference between NERR treatment duration arms is NERR-21 - NERR-14.||0.5|-3.7|0.140
71744545|NCT02781610|143000032|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.563|TWO_SIDED|95.0|-0.42|0.77|||t-test, 2 sided|||Difference between ERR treatment duration arms is ERR-10 - ERR-14.||0.77|-0.42|0.563
71744546|NCT02781610|143000033|SUPERIORITY|Difference between NERR treatment duration arms is NERR-21 - NERR-14.|Mean Difference (Final Values)|0.29||||0.083|TWO_SIDED|95.0|-0.04|0.61|||t-test, 2 sided|||||0.61|-0.04|0.083
71744547|NCT00549445|143000068|OTHER|Student t test||||||0.045||||||Threshold for significance is P-Value \< 0.05|t-test, 1 sided|||||||0.045
71744548|NCT02719171|143000069|OTHER||Mean Difference (Final Values)|24.0||||0.007|TWO_SIDED|90.0|9.3|38.7|||Cochran-Mantel-Haenszel|||The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.||38.7|9.3|0.007
71744549|NCT02719171|143000070|OTHER||Mean Difference (Final Values)|12.0||||0.074|TWO_SIDED|90.0|1.0|23.0|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||23.0|1.0|0.074
71744550|NCT02719171|143000070|OTHER||Mean Difference (Final Values)|19.0||||0.007|TWO_SIDED|90.0|7.4|30.6|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||30.6|7.4|0.007
71744551|NCT02719171|143000071|OTHER||Mean Difference (Final Values)|10.3||||0.006|TWO_SIDED|90.0|4.1|16.4|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||16.4|4.1|0.006
71744552|NCT02719171|143000071|OTHER||Mean Difference (Final Values)|15.7|||<|0.001|TWO_SIDED|90.0|8.5|22.9|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||22.9|8.5|<0.001
71744553|NCT02719171|143000072|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|90.0|-4.0|2.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.5|-4.0|0.690
71744554|NCT02719171|143000072|OTHER||Mean Difference (Final Values)|-2.1||||0.26|TWO_SIDED|90.0|-5.3|1.0|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.0|-5.3|0.260
71664700|NCT01371747|142842968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71744555|NCT02719171|143000073|OTHER||Mean Difference (Final Values)|-0.3||||0.791|TWO_SIDED|90.0|-2.1|1.5|||Cochran-Mantel-Haenszel|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-2.1|0.791
71744556|NCT02719171|143000073|OTHER||Mean Difference (Final Values)|-1.1||||0.32|TWO_SIDED|90.0|-2.8|0.7|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.7|-2.8|0.320
71744557|NCT02719171|143000074|OTHER||mixed model repeated measures model|-0.082||||0.341|TWO_SIDED|90.0|-0.225|0.06|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.060|-0.225|0.341
71744558|NCT02719171|143000074|OTHER||Mean Difference (Final Values)|-0.114||||0.181|TWO_SIDED|90.0|-0.254|0.027|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.027|-0.254|0.181
71744559|NCT02719171|143000075|OTHER||Mean Difference (Final Values)|1.7||||0.174|TWO_SIDED|90.0|-0.36|3.77|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.77|-0.36|0.174
71744560|NCT02719171|143000075|OTHER||Mean Difference (Final Values)|1.35||||0.284|TWO_SIDED|90.0|-0.73|3.44|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.44|-0.73|0.284
71744561|NCT02719171|143000076|OTHER||Mean Difference (Final Values)|0.59||||0.718|TWO_SIDED|90.0|-2.12|3.3|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||3.30|-2.12|0.718
71744562|NCT02719171|143000076|OTHER||Mean Difference (Final Values)|2.06||||0.204|TWO_SIDED|90.0|-0.61|4.74|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||4.74|-0.61|0.204
71744563|NCT02719171|143000077|OTHER||Mean Difference (Final Values)|1.2||||0.243|TWO_SIDED|90.0|-0.5|2.8|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||2.8|-0.5|0.243
71744564|NCT02719171|143000077|OTHER||Mean Difference (Final Values)|0.1||||0.906|TWO_SIDED|90.0|-1.0|1.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.1|-1.0|0.906
71744565|NCT02719171|143000078|OTHER||Mean Difference (Final Values)|-0.7||||0.325|TWO_SIDED|90.0|-1.8|0.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.5|-1.8|0.325
71744566|NCT02719171|143000078|OTHER||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED|90.0|-2.1|0.2|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.2|-2.1|0.160
71744567|NCT02719171|143000079|OTHER||Mean Difference (Final Values)|-1.2||||0.453|TWO_SIDED|90.0|-4.0|1.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||1.5|-4.0|0.453
71744568|NCT02719171|143000079|OTHER||Mean Difference (Final Values)|-2.8||||0.111|TWO_SIDED|90.0|-5.7|0.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.||0.1|-5.7|0.111
71664701|NCT01371747|142842968|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71744569|NCT02719171|143000080|OTHER||Mean Difference (Final Values)|53.5|||<|0.001|TWO_SIDED|90.0|35.9|71.1|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||71.1|35.9|<0.001
71664702|NCT01371747|142842969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664703|NCT01371747|142842969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-Value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664704|NCT01371747|142842969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664705|NCT01371747|142842969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664706|NCT01371747|142842969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71744570|NCT02719171|143000080|OTHER||Mean Difference (Final Values)|48.8|||<|0.001|TWO_SIDED|90.0|33.1|64.5|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.||64.5|33.1|<0.001
71744571|NCT02796677|143000081|SUPERIORITY||LS mean difference|0.084|||<|0.0001|TWO_SIDED|95.0|0.051|0.117|||Mixed model for repeated measures|||||0.117|0.051|<0.0001
71744572|NCT02796677|143000082|SUPERIORITY||LS mean difference|0.055||||0.0009|TWO_SIDED|95.0|0.023|0.088|||Mixed model for repeated measures|||||0.088|0.023|0.0009
71777870|NCT01967342|143054860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.243||0.305|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.||||.305
71777871|NCT01967342|143054861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.086|STANDARD_ERROR_OF_MEAN|0.623||0.082|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.||||.082
71664707|NCT01371747|142842969|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-value \<0.001|ANCOVA|||Each starting dose group was compared to its baseline.||||<0.001
71664708|NCT01371747|142842970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.54|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71744573|NCT02796677|143000083|NON_INFERIORITY|Non-inferiority was established by showing that the lower bound of the two-sided 95% confidence interval for change from baseline in morning pre-dose (trough) FEV1 at week 24 when compared AB 400 μg versus TIO 18 μg was higher than -50 mL (non-inferiority limit).|LS mean difference|0.007||||0.6377|TWO_SIDED|95.0|-0.021|0.035|||Mixed model for repeated measures|||||0.035|-0.021|0.6377
71744574|NCT02796677|143000084|SUPERIORITY||LS mean difference|0.075|||<|0.0001|TWO_SIDED|95.0|0.043|0.107|||Mixed model for repeated measures|||||0.107|0.043|<0.0001
71664709|NCT01371747|142842970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664710|NCT01371747|142842970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664711|NCT01371747|142842970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.0|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664712|NCT01371747|142842970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.96|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71744575|NCT02796677|143000084|SUPERIORITY||LS mean difference|0.087|||<|0.0001|TWO_SIDED|95.0|0.052|0.122|||Mixed model for repeated measures|||||0.122|0.052|<0.0001
71744576|NCT02796677|143000085|SUPERIORITY||Odds ratio|0.96||||0.8714|TWO_SIDED|95.0|0.61|1.51|||Logistic random-effect model|||||1.51|0.61|0.8714
71744577|NCT02796677|143000085|SUPERIORITY||Odds ratio|0.97||||0.8873|TWO_SIDED|95.0|0.59|1.58|||Logistic random-effect model|||||1.58|0.59|0.8873
71777872|NCT01967342|143054861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.532||0.652|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.||||.652
71664713|NCT01371747|142842970|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.17|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664714|NCT01371747|142842971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664715|NCT01371747|142842971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.22|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664716|NCT01371747|142842971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664717|NCT01371747|142842971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.41|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664718|NCT01371747|142842971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.39|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664719|NCT01371747|142842971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.58|||||TWO_SIDED||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.||||
71664720|NCT01371747|142842972|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.3|100.0|||||2-sided 95% exact binomial CI|||100.0|94.3|
71664721|NCT01371747|142842972|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|94.5|100.0|||||2-sided 95% exact binomial CI|||100|94.5|
71664722|NCT01371747|142842972|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|98.4|||||TWO_SIDED|95.0|91.6|100.0|||||2-sided 95% exact binomial CI|||100|91.6|
71744578|NCT01045967|143000098|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|90.7|122.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||122|90.7|
71744579|NCT01045967|143000099|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.2|||||TWO_SIDED|90.0|86.1|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.1|
71744580|NCT01045967|143000100|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|86.3|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|86.3|
71744581|NCT00945282|143000191|SUPERIORITY||Mean Difference (Final Values)|-0.932||||0.042|TWO_SIDED|95.0|-1.812|-0.053|||ANCOVA|||||-0.053|-1.812|0.042
71744582|NCT00945282|143000192|SUPERIORITY||Mean Difference (Final Values)|-0.413||||0.221|TWO_SIDED|95.0|-1.173|0.347|||ANCOVA|||||0.347|-1.173|0.221
71744583|NCT00945282|143000193|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is the value for GSK2248761 30 mg, at Day 1 to Day 8|Mixed Models Analysis|||Day 1 to Day 8||||<0.0001
71744584|NCT00945282|143000193|SUPERIORITY_OR_OTHER|||||||0.6922||||||The p-value is the value for placebo, at Day 1 to Day 8|Mixed Models Analysis|||Placebo, Day 1 to Day 8||||0.6922
71744585|NCT03101566|143000209|OTHER||||||||||||||||||PFS at 6 months was estimated for this trial using the product-limit method of Kaplan and Meier with 95% confidence intervals calculated using Greenwood's formula. All statistical analyses were completed using the SAS System, v9.4 \[Cary, NC, USA\].|||
71744586|NCT01623115|143000233|SUPERIORITY_OR_OTHER||LS mean difference|-57.9|||<|0.0001|TWO_SIDED|95.0|-63.3|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-52.6|-63.3|<0.0001
71744587|NCT01623115|143000234|SUPERIORITY_OR_OTHER||LS mean difference|-58.1|||<|0.0001|TWO_SIDED|95.0|-63.5|-52.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-52.7|-63.5|<0.0001
71744588|NCT01623115|143000235|SUPERIORITY_OR_OTHER||LS mean difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-53.9|-44.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.5|-53.9|<0.0001
71744589|NCT01623115|143000236|SUPERIORITY_OR_OTHER||LS mean difference|-49.5|||<|0.0001|TWO_SIDED|95.0|-54.2|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)||-44.8|-54.2|<0.0001
71664723|NCT01371747|142842972|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
71744590|NCT01623115|143000237|SUPERIORITY_OR_OTHER||LS mean difference|-45.8|||<|0.0001|TWO_SIDED|95.0|-49.8|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.8|<0.0001
71744591|NCT01623115|143000238|SUPERIORITY_OR_OTHER||LS mean difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-49.9|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.8|-49.9|<0.0001
71744592|NCT01623115|143000239|SUPERIORITY_OR_OTHER||LS mean difference|-52.4|||<|0.0001|TWO_SIDED|95.0|-57.2|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.6|-57.2|<0.0001
71744593|NCT01623115|143000240|SUPERIORITY_OR_OTHER||LS mean difference|-52.6|||<|0.0001|TWO_SIDED|95.0|-57.5|-47.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-57.5|<0.0001
71744594|NCT01623115|143000241|SUPERIORITY_OR_OTHER||LS mean difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-42.4|-35.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35|-42.4|<0.0001
71744595|NCT01623115|143000242|SUPERIORITY_OR_OTHER||LS mean difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-41.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-41.2|<0.0001
71744596|NCT01623115|143000243|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.7|||<|0.0001|TWO_SIDED|95.0|-48.0|-39.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.4|-48|<0.0001
71664724|NCT01371747|142842972|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.8|||||TWO_SIDED|95.0|78.9|99.9|||||2-sided 95% exact binomial CI|||99.9|78.9|
71664725|NCT01371747|142842972|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.5|||||TWO_SIDED|95.0|77.2|99.9|||||2-sided 95% exact binomial CI|||99.9|77.2|
71664726|NCT01371747|142842973|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|95.2|||||TWO_SIDED|95.0|86.7|99.0|||||2-sided 95% exact binomial CI|||99.0|86.7|
71664727|NCT01371747|142842973|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.8|||||TWO_SIDED|95.0|81.0|96.5|||||2-sided 95% exact binomial CI|||96.5|81.0|
71664728|NCT01371747|142842973|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.3|||||TWO_SIDED|95.0|69.5|89.9|||||2-sided 95% exact binomial CI|||89.9|69.5|
71664729|NCT01371747|142842973|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|79.2|||||TWO_SIDED|95.0|57.8|92.9|||||2-sided 95% exact binomial CI|||92.9|57.8|
71744597|NCT01623115|143000244|SUPERIORITY_OR_OTHER||LS mean difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-35.7|<0.0001
71744598|NCT01623115|143000245|SUPERIORITY_OR_OTHER||LS mean difference|-56.2|||<|0.0001|TWO_SIDED|95.0|-62.4|-50.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50|-62.4|<0.0001
71890932|NCT01587950|143303694|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.07||||0.8703|TWO_SIDED|95.0|-14.11|11.97|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.||11.97|-14.11|0.8703
71664730|NCT01371747|142842973|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|91.7|||||TWO_SIDED|95.0|73.0|99.0|||||2-sided 95% exact binomial CI|||99|73|
71664731|NCT01371747|142842973|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|77.3|||||TWO_SIDED|95.0|54.6|92.2|||||2-sided 95% exact binomial CI|||92.2|54.6|
71664732|NCT01371747|142842975|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.3|||||TWO_SIDED|95.0|73.7|94.3|||||2-sided 95% exact binomial CI|||94.3|73.7|
71664733|NCT01371747|142842975|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|81.6|||||TWO_SIDED|95.0|68.0|91.2|||||2-sided 95% exact binomial CI|||91.2|68.0|
71664734|NCT01371747|142842975|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|88.9|||||TWO_SIDED|95.0|75.9|96.3|||||2-sided 95% exact binomial CI|||96.3|75.9|
71664735|NCT01371747|142842975|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|86.7|||||TWO_SIDED|95.0|59.5|98.3|||||2-sided 95% exact binomial CI|||98.3|59.5|
71664736|NCT01371747|142842975|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|89.5|||||TWO_SIDED|95.0|66.9|98.7|||||2-sided 95% exact binomial CI|||98.7|66.9|
71664737|NCT01371747|142842975|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|93.3|||||TWO_SIDED|95.0|68.1|99.8|||||2-sided 95% exact binomial CI|||99.8|68.1|
71664738|NCT03092219|142842976|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0|||||Fisher Exact|For this outcome measure, missing data were imputed using a LOCF (Last Observation Carried Forward) method.||||||0.0001
71664739|NCT00580788|142843021|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71664740|NCT00580788|142843021|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
71664741|NCT00580788|142843023|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to all Arms/Groups at all time points compared to baseline|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.61
71664742|NCT00580788|142843024|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|Value The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
71664743|NCT00580788|142843025|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.0001
71664744|NCT00580788|142843026|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time from baseline for all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
71890933|NCT04211337|143303711|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.165|0.475|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.475|0.165|<0.0001
71664745|NCT00580788|142843027|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
71664746|NCT00580788|142843027|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71664747|NCT00580788|142843028|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71744599|NCT01623115|143000246|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.0|||<|0.0001|TWO_SIDED|95.0|48.9|498.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||498.1|48.9|<0.0001
71744600|NCT01623115|143000247|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.6|||<|0.0001|TWO_SIDED|95.0|49.7|493.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||493.7|49.7|<0.0001
71744601|NCT01623115|143000248|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|244.9|||<|0.0001|TWO_SIDED|95.0|34.4|1744.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1744.4|34.4|<0.0001
71744602|NCT01623115|143000249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.0|||<|0.0001|TWO_SIDED|95.0|33.9|1700.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1700.7|33.9|<0.0001
71744603|NCT01623115|143000250|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-22.6|-12.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.9|-22.6|<0.0001
71744604|NCT01623115|143000251|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11|5|<0.0001
71744605|NCT01623115|143000252|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-21.3|-10.6||Threshold for significance was ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.6|-21.3|<0.0001
71744606|NCT01623115|143000253|SUPERIORITY_OR_OTHER||LS mean difference|4.7|||=|0.0002|TWO_SIDED|95.0|2.3|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|2.3|= 0.0002
71744607|NCT01623115|143000254|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-21.5|-13.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13|-21.5|<0.0001
71744608|NCT01623115|143000255|SUPERIORITY_OR_OTHER||LS mean difference|4.3||||0.0031|TWO_SIDED|95.0|1.5|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.2|1.5|0.0031
71744609|NCT01623115|143000256|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.7||||0.0003|TWO_SIDED|95.0|-15.0|-4.4||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.4|-15|0.0003
71744610|NCT01623115|143000257|SUPERIORITY_OR_OTHER||LS mean difference|2.8||||0.0187|TWO_SIDED|95.0|0.5|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|0.5|0.0187
71744611|NCT02119871|143000261|SUPERIORITY||Median Difference (Final Values)|14.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.00
71777873|NCT01967342|143054861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.416|STANDARD_ERROR_OF_MEAN|0.612|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.||||< .001
71664748|NCT00580788|142843028|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71664749|NCT00580788|142843029|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71664750|NCT00580788|142843029|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.01
71664751|NCT00580788|142843030|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.001|TWO_SIDED|||||the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||0.001
71664752|NCT00580788|142843030|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p=value corresponds to % change compared to baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
71664753|NCT00580788|142843031|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<0.05
71664754|NCT00580788|142843032|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
71744612|NCT02119871|143000262|SUPERIORITY||Median Difference (Final Values)|10.0||||0.656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.656
71744613|NCT02119871|143000263|SUPERIORITY||Median Difference (Final Values)|4.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1
71744614|NCT01329978|143000302|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4||||0.77|TWO_SIDED|95.0|-12.2|9.4||The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions.|The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.||9.4|-12.2|0.77
71744615|NCT01329978|143000302|SUPERIORITY_OR_OTHER||Difference in proportions|-0.4||||0.93|TWO_SIDED|95.0|-10.8|9.9||The p-value is based on the CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel|The difference in proportions and its 95% CI were calculated based on stratum-adjusted MH proportions.||The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (\< 800,000 IU/mL versus ≥ 800,000 IU/mL).||9.9|-10.8|0.93
71744616|NCT03324802|143000324|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
71744617|NCT03324802|143000325|SUPERIORITY|||||||1|||||||Log Rank|||||||1.0
71744618|NCT03324802|143000327|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.320
71777874|NCT01967342|143054861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.619|STANDARD_ERROR_OF_MEAN|0.528||0.241|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.||||.241
71664755|NCT02045147|142843068|OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|3.82||0.463|TWO_SIDED|95.0|-4.98|10.65|||t-test, 2 sided|||||10.65|-4.98|0.463
71664756|NCT02045147|142843068|OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|3.4||0.634|TWO_SIDED|95.0|-5.23|8.49|||t-test, 2 sided|||||8.49|-5.23|0.634
71664757|NCT02045147|142843068|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.15||0.259|TWO_SIDED|95.0|-3.74|13.32|||t-test, 2 sided|||||13.32|-3.74|0.259
71664758|NCT02045147|142843068|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED|95.0|-3.21|6.84|||t-test, 2 sided|||||6.84|-3.21|0.472
71664759|NCT02045147|142843069|OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.15||0.532|TWO_SIDED|95.0|-8.5|4.5|||t-test, 2 sided|||||4.5|-8.5|0.532
71664760|NCT02045147|142843069|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|2.9||0.574|TWO_SIDED|95.0|-7.5|4.2|||t-test, 2 sided|||||4.2|-7.5|0.574
71664761|NCT02045147|142843069|OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.254|TWO_SIDED|95.0|-12.3|3.4|||t-test, 2 sided|||||3.4|-12.3|0.254
71664762|NCT02045147|142843069|OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.7||0.759|TWO_SIDED|95.0|-6.3|4.6|||t-test, 2 sided|||||4.6|-6.3|0.759
71664763|NCT02045147|142843070|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|3.6||0.153|TWO_SIDED|95.0|-2.1|12.7|||t-test, 2 sided|||||12.7|-2.1|0.153
71744619|NCT03324802|143000328|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
71744620|NCT03324802|143000329|SUPERIORITY|||||||0.97|||||||Log Rank|||||||0.97
71744621|NCT03324802|143000330|SUPERIORITY|||||||0.5|||||||Gray Test P-value|||||||0.5
71744622|NCT03324802|143000331|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
71744623|NCT00287716|143000342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.95|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.||0.95|0.44|0.023
71744624|NCT00287716|143000348|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.515|TWO_SIDED|95.0|0.5|1.42|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.||1.42|0.50|0.515
71744625|NCT04532034|143000351|OTHER||Mean Difference (Final Values)|0.067||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||.95
71664764|NCT02045147|142843070|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|3.3||0.729|TWO_SIDED|95.0|-7.9|5.5|||t-test, 2 sided|||||5.5|-7.9|0.729
71664765|NCT02045147|142843070|OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.886|TWO_SIDED|95.0|-6.6|7.6|||t-test, 2 sided|||||7.6|-6.6|0.886
71664766|NCT02045147|142843070|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.1||0.446|TWO_SIDED|95.0|-8.7|3.9|||t-test, 2 sided|||||3.9|-8.7|0.446
71664767|NCT02045147|142843071|OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.1||0.521|TWO_SIDED|95.0|-5.7|11.1|||t-test, 2 sided|||||11.1|-5.7|0.521
71664768|NCT02045147|142843071|OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.7||0.146|TWO_SIDED|95.0|-1.5|9.5|||t-test, 2 sided|||||9.5|-1.5|0.146
71777875|NCT01967342|143054861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.251|STANDARD_ERROR_OF_MEAN|0.617|<|0.001|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.||||< .001
71777876|NCT01967342|143054861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.434|STANDARD_ERROR_OF_MEAN|0.541||0.422|TWO_SIDED|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.||||.422
71777877|NCT01967342|143054862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.45|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).||||<.001
71664769|NCT02045147|142843071|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.3||0.926|TWO_SIDED|95.0|-8.5|9.3|||t-test, 2 sided|||||9.3|-8.5|0.926
71664770|NCT02045147|142843071|OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|2.4||0.526|TWO_SIDED|95.0|-6.4|3.3|||t-test, 2 sided|||||3.3|-6.4|0.526
71664771|NCT02045147|142843072|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|3.9||0.776|TWO_SIDED|95.0|-9.2|6.9|||t-test, 2 sided|||||6.9|-9.2|0.776
71664772|NCT02045147|142843072|OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.135|TWO_SIDED|95.0|-1.6|11.7|||t-test, 2 sided|||||11.7|-1.6|0.135
71664773|NCT02045147|142843072|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.1||0.556|TWO_SIDED|95.0|-10.9|6.0|||t-test, 2 sided|||||6.0|-10.9|0.556
71664774|NCT02045147|142843072|OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|2.7||0.361|TWO_SIDED|95.0|-2.9|7.9|||t-test, 2 sided|||||7.9|-2.9|0.361
71664775|NCT02045147|142843073|OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.4||0.564|TWO_SIDED|95.0|-6.4|11.6|||t-test, 2 sided|||||11.6|-6.4|0.564
71664776|NCT02045147|142843073|OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|3.1||0.307|TWO_SIDED|95.0|-3.0|9.3|||t-test, 2 sided|||||9.3|-3.0|0.307
71664777|NCT02045147|142843073|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.8||0.768|TWO_SIDED|95.0|-6.7|8.9|||t-test, 2 sided|||||8.9|-6.7|0.768
71664778|NCT02045147|142843073|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.785|TWO_SIDED|95.0|-4.2|5.5|||t-test, 2 sided|||||5.5|-4.2|0.785
71664779|NCT02045147|142843074|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.5||0.917|TWO_SIDED|95.0|-7.5|6.8|||t-test, 2 sided|||||6.8|-7.5|0.917
71664780|NCT02045147|142843074|OTHER||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|3.3||0.181|TWO_SIDED|95.0|-2.2|11.3|||t-test, 2 sided|||||11.3|-2.2|0.181
71664781|NCT02045147|142843074|OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.6||0.772|TWO_SIDED|95.0|-6.3|8.3|||t-test, 2 sided|||||8.3|-6.3|0.772
71664782|NCT02045147|142843074|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|2.8||0.526|TWO_SIDED|95.0|-3.8|7.3|||t-test, 2 sided|||||7.3|-3.8|0.526
71664783|NCT02045147|142843075|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.42||0.872|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided|||||.9|-.8|0.872
71664784|NCT02045147|142843075|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.387|TWO_SIDED|95.0|-0.87|0.34|||t-test, 2 sided|||||.34|-.87|0.387
71664785|NCT02045147|142843075|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.916|TWO_SIDED|95.0|-0.37|0.81|||t-test, 2 sided|||||.81|-.37|0.916
71664786|NCT02045147|142843075|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.189|TWO_SIDED|95.0|-0.19|0.94|||t-test, 2 sided|||||.94|-.19|0.189
71664787|NCT02045147|142843076|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.627|TWO_SIDED|95.0|-0.21|0.13|||t-test, 2 sided|||||.13|-.21|0.627
71664788|NCT02045147|142843076|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.84|TWO_SIDED|95.0|-0.11|0.09|||t-test, 2 sided|||||.09|-.11|0.840
71744626|NCT04170543|143000352|OTHER||LS Mean Difference in Percent Change|-2.85||||0.8338|TWO_SIDED|90.0|-22.61|21.94||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||21.94|-22.61|0.8338
71744627|NCT04170543|143000352|OTHER||LS Mean Difference in Percent Change|-19.52||||0.1169|TWO_SIDED|90.0|-35.92|1.07||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||1.07|-35.92|0.1169
71744628|NCT04170543|143000352|OTHER||LS Mean Difference in Percent Change|-17.47||||0.1774|TWO_SIDED|90.0|-34.71|4.32||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||4.32|-34.71|0.1774
71664789|NCT02045147|142843076|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|-0.22|0.0|||t-test, 2 sided|||||-.00|-.22|0.049
71664790|NCT02045147|142843076|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.952|TWO_SIDED|95.0|-0.06|0.06|||t-test, 2 sided|||||.06|-.06|0.952
71664791|NCT02045147|142843077|OTHER||Mean Difference (Final Values)|6.9||||0.436|TWO_SIDED|95.0|-11.07|25.0|||t-test, 2 sided|||||25.00|-11.07|.436
71664792|NCT02045147|142843077|OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|6.71||0.088|TWO_SIDED|95.0|-25.24|1.8|||t-test, 2 sided|||||1.80|-25.24|.088
71664793|NCT02045147|142843077|OTHER||Median Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.45||0.169|TWO_SIDED|95.0|-25.86|4.77|||t-test, 2 sided|||||4.77|-25.86|0.169
71664794|NCT02045147|142843077|OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|4.52||0.416|TWO_SIDED|95.0|-12.79|5.37|||t-test, 2 sided|||||5.37|-12.79|0.416
71744629|NCT04170543|143000352|OTHER||LS Mean Difference in Percent Change|-7.22||||0.5379|TWO_SIDED|90.0|-24.05|13.35||Unadjusted two-sided p-value|MMRM|||||13.35|-24.05|0.5379
71744630|NCT04170543|143000353|OTHER||LS Mean Difference in Percent Change|-13.02||||0.1929|TWO_SIDED|90.0|-27.08|3.75||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||3.75|-27.08|0.1929
71777878|NCT01967342|143054862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).||||.001
71664795|NCT02052011|142843091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.08|0.62||||||||0.62|-0.08|
71744631|NCT04170543|143000353|OTHER||LS Mean Difference in Percent Change|-25.71||||0.0062|TWO_SIDED|90.0|-37.83|-11.22||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-11.22|-37.83|0.0062
71777879|NCT01967342|143054862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.217|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).||||.217
71664796|NCT02960490|142843095|SUPERIORITY||Difference from Placebo|-4.7||||0.621|TWO_SIDED|95.0|-25.85|16.46|||Regression, Logistic|||||16.46|-25.85|0.621
71664797|NCT01266031|142843116|SUPERIORITY_OR_OTHER|||||||0.26||||||Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|Chi-squared|||Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.||||0.26
71664798|NCT00447876|142843158|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.2|||=|0.182|TWO_SIDED|95.0|-0.06|0.46|||Fisher Exact|||The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.||0.46|-0.06|=0.182
71664799|NCT00447876|142843159|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.222|||||||Cochran-Mantel-Haenszel|||Gerbershagen's Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.||||=0.222
71664800|NCT00447876|142843161|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.837|||=|0.423|TWO_SIDED|95.0|-30.94|13.266|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||13.266|-30.940|=0.423
71664801|NCT00447876|142843163|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.173|||=|0.682|TWO_SIDED|95.0|-24.64|16.294|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||16.294|-24.640|=0.682
71664802|NCT00447876|142843165|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.066|||=|0.438|TWO_SIDED|95.0|-28.91|12.779|||ANCOVA|||The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||12.779|-28.910|=0.438
71664803|NCT00447876|142843167|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.594|||=|0.937|TWO_SIDED|95.0|-14.575|15.762|||ANCOVA|||The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.||15.762|-14.575|=0.937
71664804|NCT00447876|142843168|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||=|0.8|TWO_SIDED|95.0|-6.8|5.3||The difference (most affected side - control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.|ANCOVA|||||5.3|-6.8|=0.800
71664805|NCT00447876|142843169|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.862|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.862
71664806|NCT00447876|142843169|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.317|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.317
71744632|NCT04170543|143000353|OTHER||LS Mean Difference in Percent Change|-18.2||||0.0705|TWO_SIDED|90.0|-31.86|-1.81||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-1.81|-31.86|0.0705
71744633|NCT04170543|143000353|OTHER||LS Mean Difference in Percent Change|-15.56||||0.0764|TWO_SIDED|90.0|-27.82|-1.21||Unadjusted two-sided p-value|MMRM|||||-1.21|-27.82|0.0764
71744634|NCT04170543|143000354|OTHER||LS Mean Difference in Percent Change|7.25||||0.5474|TWO_SIDED|90.0|-11.45|29.88||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||29.88|-11.45|0.5474
71777880|NCT01967342|143054862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.009|TWO_SIDED||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.009
71744635|NCT04170543|143000354|OTHER||LS Mean Difference in Percent Change|3.11||||0.792|TWO_SIDED|90.0|-14.83|24.82||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||24.82|-14.83|0.7920
71744636|NCT04170543|143000354|OTHER||LS Mean Difference in Percent Change|-3.4||||0.7711|TWO_SIDED|90.0|-20.59|17.51||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||17.51|-20.59|0.7711
71664807|NCT00447876|142843169|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.525|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.525
71664808|NCT00447876|142843169|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.931
71664809|NCT00447876|142843169|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.353|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.353
71664810|NCT00447876|142843170|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.882|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.882
71664811|NCT00447876|142843170|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.489|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.489
71664812|NCT00447876|142843170|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.66|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.660
71664813|NCT00447876|142843170|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.485|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.485
71664814|NCT00447876|142843170|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.392|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.||||=0.392
71664815|NCT01256944|142843171|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664816|NCT01256944|142843172|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664817|NCT01256944|142843173|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664818|NCT01256944|142843175|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664819|NCT01256944|142843176|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664820|NCT01256944|142843177|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664821|NCT01256944|142843178|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664822|NCT01256944|142843180|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664823|NCT01256944|142843181|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71664824|NCT02047734|142843189|SUPERIORITY||Rate Ratio|0.623|||<|0.0001|TWO_SIDED|95.0|0.506|0.768||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson regression model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.768|0.506|<0.0001
71664825|NCT02047734|142843189|SUPERIORITY||Rate Ratio|0.791||||0.0167|TWO_SIDED|95.0|0.652|0.958||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.|Poisson Regression Model|Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.958|0.652|0.0167
71664826|NCT02047734|142843190|SUPERIORITY||Rate Ratio|0.576|||<|0.0001|TWO_SIDED|95.0|0.465|0.714||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions, and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.714|0.465|<0.0001
71664827|NCT02047734|142843190|SUPERIORITY||Rate Ratio|0.657||||0.0001|TWO_SIDED|95.0|0.531|0.813||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model|Adjusted for region, age, and Baseline GdE lesions and included the natural log transformation of available number of MRI scans as an offset term.|Rate Ratio = Ozanimod / IFN β-1a|||0.813|0.531|0.0001
71744637|NCT04170543|143000354|OTHER||LS Mean Difference in Percent Change|5.27||||0.6163|TWO_SIDED|90.0|-11.08|24.62||Unadjusted two-sided p-value|MMRM|||||24.62|-11.08|0.6163
71744638|NCT04170543|143000356|OTHER||LS Mean Difference in Percent Change|2.43||||0.8537|TWO_SIDED|90.0|-17.35|26.95||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||26.95|-17.35|0.8537
71744639|NCT04170543|143000356|OTHER||LS Mean Difference in Percent Change|-15.63||||0.1989|TWO_SIDED|90.0|-32.14|4.89||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||4.89|-32.14|0.1989
71744640|NCT04170543|143000356|OTHER||LS Mean Difference in Percent Change|-17.96||||0.1346|TWO_SIDED|90.0|-34.01|1.99||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||1.99|-34.01|0.1346
71744641|NCT04170543|143000356|OTHER||LS Mean Difference in Percent Change|-6.38||||0.5683|TWO_SIDED|90.0|-22.59|13.23||Unadjusted two-sided p-value|MMRM|||||13.23|-22.59|0.5683
71744642|NCT04170543|143000357|OTHER||LS Mean Difference in Percent Change|-7.93||||0.4226|TWO_SIDED|90.0|-22.3|9.1||Unadjusted two-sided p-value|MMRM||MEDI3506 30 mg - Placebo|||9.10|-22.30|0.4226
71744643|NCT04170543|143000357|OTHER||LS Mean Difference in Percent Change|-20.61||||0.0287|TWO_SIDED|90.0|-33.25|-5.58||Unadjusted two-sided p-value|MMRM||MEDI3506 60 mg - Placebo|||-5.58|-33.25|0.0287
71744644|NCT04170543|143000357|OTHER||LS Mean Difference in Percent Change|-18.73||||0.0498|TWO_SIDED|90.0|-31.7|-3.3||Unadjusted two-sided p-value|MMRM||MEDI3506 120 mg - Placebo|||-3.30|-31.70|0.0498
71744645|NCT04170543|143000357|OTHER||LS Mean Difference in Percent Change|-13.27||||0.1236|TWO_SIDED|90.0|-25.51|0.98||Unadjusted two-sided p-value|MMRM|||||0.98|-25.51|0.1236
71744646|NCT01236521|143000386|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_DEVIATION|0.13||0.0385|TWO_SIDED||||||Mixed Models Analysis|||||||0.0385
71744647|NCT01236521|143000387|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_DEVIATION|0.11||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
71744648|NCT01236521|143000388|SUPERIORITY||Median Difference (Net)|0.39|STANDARD_DEVIATION|0.15||0.074|TWO_SIDED||||||Mixed Models Analysis|||||||0.0740
71744649|NCT04037891|143000398|SUPERIORITY||Difference of percentage of participants|16.7|||||TWO_SIDED|95.0|-53.57|72.99||||||||72.99|-53.57|
71744650|NCT04037891|143000398|SUPERIORITY||Difference of percentage of participants|33.3|||||TWO_SIDED|95.0|-25.45|78.39||||||Comparison of incidence of ocular TEAE in all patients receiving rVA576 (part 1 and 2) vs placebo||78.39|-25.45|
71777881|NCT01967342|143054862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.32||||0.001|TWO_SIDED||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.001
71777882|NCT01967342|143054862|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.389|TWO_SIDED||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).||||.389
71777883|NCT03789214|143054868|OTHER|One-way ANOVA||||||0.95|||||||ANOVA|||||||.950
71777884|NCT03789214|143054869|OTHER|One-way ANOVA||||||0.048|||||||ANOVA|||||||.048
71777885|NCT03789214|143054870|OTHER|One-way ANOVA||||||0.691|||||||ANOVA|||||||.691
71890934|NCT04211337|143303712|SUPERIORITY||Hazard Ratio (HR)|0.254|||<|0.0001|TWO_SIDED|95.0|0.153|0.423|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|||0.423|0.153|<0.0001
71890935|NCT04211337|143303713|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.0001|TWO_SIDED|95.0|2.2|6.3||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib)|Clopper-Pearson method|||||6.3|2.2|<0.0001
71744651|NCT05274958|143000409|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Patient measures for both groups were first summarized descriptively with means and standard deviations. To compare the two groups, a t-test was used.||||<0.05
71777886|NCT03789214|143054871|OTHER|One-way ANOVA||||||0.62|||||||ANOVA|||||||.620
71777887|NCT03789214|143054872|OTHER|One-way ANOVA||||||0.067|||||||ANOVA|||||||.067
71744652|NCT04491136|143000418|OTHER||||||>|0.9999|||||||McNemar|||At least one SVT occurred||||>0.9999
71744653|NCT04491136|143000418|OTHER|||||||0.7905|||||||McNemar|||At least one NSVT occurred||||0.7905
71744654|NCT04491136|143000418|OTHER|||||||0.625|||||||McNemar|||At least one PVC occurred||||0.6250
71744655|NCT04491136|143000420|OTHER||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.653||0.0008|TWO_SIDED|95.0|1.11|3.7|||Wilcoxon signed-rank|||||3.70|1.11|0.0008
71744656|NCT04491136|143000421|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.028||0.5733|TWO_SIDED|95.0|-0.07|0.04|||Ridit analysis|||||0.04|-0.07|0.5733
71744657|NCT04491136|143000422|OTHER||Mean Difference (Final Values)|-231.46|STANDARD_ERROR_OF_MEAN|93.03||0.0006|TWO_SIDED|95.0|-415.9|-47.02|||Wilcoxon signed rank test|||||-47.02|-415.90|0.0006
71744658|NCT04491136|143000424|OTHER||||||>|0.9999|||||||McNemar|||Occurrence of at least one shock||||>0.9999
71744659|NCT04491136|143000424|OTHER|||||||0.0654|||||||McNemar|||Occurrence of at least one ATP event||||0.0654
71777888|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|-10.59|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
71777889|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|2.18|STANDARD_ERROR_OF_MEAN|2.42||0.1858|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.1858
71777890|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|8.66|STANDARD_ERROR_OF_MEAN|2.55||0.0007|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0007
71777891|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|14.45|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71777892|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|-14.14|STANDARD_ERROR_OF_MEAN|4.55|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
71777893|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|1.91|STANDARD_ERROR_OF_MEAN|4.56||0.3384|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3384
71777894|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|19.38|STANDARD_ERROR_OF_MEAN|3.94|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71777895|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|38.37|STANDARD_ERROR_OF_MEAN|9.76||0.0002|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.0002
71777896|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|-23.96|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|||||Testing procedure stopped|Mixed Models Analysis|||Holm's Step-Down Method||||
71777897|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|2.47|STANDARD_ERROR_OF_MEAN|5.4||0.3249|TWO_SIDED|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||0.3249
71890936|NCT04211337|143303714|SUPERIORITY||Hazard Ratio (HR)|0.275||||0.0004|TWO_SIDED|95.0|0.129|0.587|||Log Rank|Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).||||0.587|0.129|0.0004
71890937|NCT04211337|143303717|SUPERIORITY||Mean Difference (Final Values)|-0.16|||<|0.0001|TWO_SIDED|95.0|-0.23|-0.1||Stratified by RET mutation type (M918T vs. Others) and intended treatment if randomized to Arm B (Vandetanib vs. Cabozantinib).|Wilcoxon (Mann-Whitney)|||||-0.10|-0.23|<0.0001
71890938|NCT02847598|143303746|SUPERIORITY||Least squares (LS) mean Difference|-3.4||||0.037|TWO_SIDED|95.0|-6.7|-0.2|||MMRM|||A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.2|-6.7|0.037
71890939|NCT02847598|143303747|SUPERIORITY||LS mean difference|-24.29||||0.015|TWO_SIDED|95.0|-43.7|-4.88|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-4.88|-43.70|0.015
71744660|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.483
71744661|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.698||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.698
71744662|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.782
71744663|NCT00452790|143000451|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744664|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.729||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.729
71744665|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744666|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.819||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.819
71744667|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.904
71777898|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|29.23|STANDARD_ERROR_OF_MEAN|6.53|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71777899|NCT02633501|143054922|SUPERIORITY||Least Squares Mean|51.96|STANDARD_ERROR_OF_MEAN|10.68|<|0.0001|TWO_SIDED|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method||||<0.0001
71890940|NCT02847598|143303747|SUPERIORITY||LS mean difference|-33.42|||<|0.001|TWO_SIDED|95.0|-52.71|-14.12|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-14.12|-52.71|<0.001
71744668|NCT00452790|143000451|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744669|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71777900|NCT00395733|143054923|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9736||||||90.0|0.9315|1.0168|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0168|0.9315|
71744670|NCT00452790|143000451|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.690
71813053|NCT01564368|143128442|SUPERIORITY||area under the curve|0.61||||0.013|ONE_SIDED|95.0||0.69||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) is considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in Apparent Diffusion Coefficients (ADC3 - ADC0)/ADC0 (Test: %change in ADC; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.69||0.013
71890941|NCT02847598|143303747|SUPERIORITY||LS mean difference|-27.99||||0.001|TWO_SIDED|95.0|-44.55|-11.42|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.42|-44.55|0.001
71777901|NCT00395733|143054923|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.954||||||90.0|0.9122|0.9965|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9965|0.9122|
71834398|NCT03363854|143172630|SUPERIORITY||Difference|0.5||||0.13|TWO_SIDED|95.0|-0.1|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 5 are reported below.||1.1|-0.1|0.13
71834399|NCT03363854|143172630|SUPERIORITY||Difference|0.3||||0.38|TWO_SIDED|95.0|-0.3|0.9||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 6 are reported below.||0.9|-0.3|0.38
71834400|NCT03363854|143172630|SUPERIORITY||Difference|0.6||||0.04|TWO_SIDED|95.0|0.0|1.2||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 7 are reported below.||1.2|0.0|0.040
71890942|NCT02847598|143303750|SUPERIORITY||LS Mean Difference|-9.93||||0.22|TWO_SIDED|95.0|-25.94|6.08|||MMRM|||Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||6.08|-25.94|0.220
71890943|NCT02847598|143303750|SUPERIORITY||LS Mean Difference|-8.96||||0.293|TWO_SIDED|95.0|-25.82|7.9|||MMRM|||Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||7.90|-25.82|0.293
71744671|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.933
71744672|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.776
71744673|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.596||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.596
71744674|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.909||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.909
71744675|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.683
71744676|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744677|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.203
71744678|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Fisher Exact|||Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.399
71744679|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.382||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.382
71744680|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744681|NCT00452790|143000452|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Fisher Exact|||Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.738
71744682|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.918||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.918
71744683|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.906||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.906
71744684|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.404
71744685|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.305
71744686|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.771||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.771
71744687|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744688|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.867||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.867
71744689|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.735||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.735
71744690|NCT00452790|143000453|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744691|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744692|NCT00452790|143000453|SUPERIORITY_OR_OTHER|||||||0.842||95.0|||||Fisher Exact|||Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.842
71744693|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.908||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.908
71744694|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.772
71744695|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.681
71744696|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.881
71744697|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.509
71813054|NCT01564368|143128443|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV1 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
71744698|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744699|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.880
71890944|NCT02847598|143303750|SUPERIORITY||LS Mean Difference|-15.74||||0.062|TWO_SIDED|95.0|-32.28|0.79|||MMRM|||Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.79|-32.28|0.062
71890945|NCT02847598|143303751|SUPERIORITY||LS mean difference|-30.36||||0.001|TWO_SIDED|95.0|-48.75|-11.97|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-11.97|-48.75|0.001
71890946|NCT02847598|143303751|SUPERIORITY||LS mean difference|-37.17|||<|0.001|TWO_SIDED|95.0|-55.46|-18.87|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-18.87|-55.46|<0.001
71890947|NCT02847598|143303751|SUPERIORITY||LS mean difference|-26.05||||0.001|TWO_SIDED|95.0|-41.71|-10.4|||MMRM|||A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (\<=10 vs. \>10) as fixed effect covariates.||-10.40|-41.71|0.001
71890948|NCT02847598|143303757|SUPERIORITY||LS Mean Difference|-1.7||||0.007|TWO_SIDED|95.0|-3.0|-0.5|||MMRM|||A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||-0.5|-3.0|0.007
71890949|NCT02847598|143303759|SUPERIORITY||LS mean difference|-0.16||||0.667|TWO_SIDED|95.0|-0.9|0.58|||MMRM|||A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (\<=10 mg, \>10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.||0.58|-0.90|0.667
71890950|NCT02848833|143303787|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
71890951|NCT02848833|143303790|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
71890952|NCT02848833|143303791|OTHER|Difference before administration versus after administration was analyzed using a paired t-test.|||||<|0.0001|||||||paired t-test|||||||<0.0001
71890953|NCT02848833|143303792|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
71890954|NCT02848833|143303793|OTHER||||||<|0.0001||||||Difference before administration versus after administration was analyzed using a paired t-test.|paired t-test|||||||<0.0001
71890955|NCT04167345|143303795|SUPERIORITY||Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.1|2.3|||t-test, 2 sided|||||2.3|1.1|<.0001
71890956|NCT04167345|143303795|SUPERIORITY||Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.9|||t-test, 2 sided|||||2.9|1.1|<.0001
71890957|NCT04167345|143303797|SUPERIORITY||Mean Difference|2.0||||0.0114|TWO_SIDED|95.0|0.5|3.4|||t-test, 2 sided|||||3.4|0.5|0.0114
71890958|NCT04167345|143303797|SUPERIORITY||Mean Difference|2.3||||0.0009|TWO_SIDED|95.0|1.1|3.5|||t-test, 2 sided|||||3.5|1.1|0.0009
71890959|NCT01252966|143303820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.14|TWO_SIDED|95.0|0.42|1.13|||Regression, Logistic|||Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen's one-sample d=0.38).||1.13|0.42|0.14
71890960|NCT01252966|143303822|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
71890961|NCT01252966|143303823|SUPERIORITY_OR_OTHER|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.30
71890962|NCT01252966|143303824|SUPERIORITY_OR_OTHER|||||||0.033||||||Results would not survive correction for multiple hypothesis testing.|Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.||||0.033
71890963|NCT03275870|143303825|OTHER|||||||0.042||||||p value \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.042
71890964|NCT03275870|143303826|OTHER|||||||0.213||||||P value of \<0.05 used as threshold for significance|t-test, 2 sided|||||||0.213
71890965|NCT02240134|143303832|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.46|3.32|||Mixed Models Analysis||Odds ratio for air filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||3.32|0.46|0.68
71890966|NCT02240134|143303832|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.35|2.72|||Mixed Models Analysis||Odds ratio for filter treatment relative to placebo|Mixed effects logistic regression model with presence of LRTI as outcome (yes or no); assigned treatment as primary exposure variable relative to placebo; adjusted for child age and person-time at-risk; nested random term: home:cohort:area. Results presented as odds ratios with 95% Confidence Intervals.||2.72|0.35|0.96
71890967|NCT02240134|143303833|SUPERIORITY||percent differences in geometric mean PM|-6.96||||0.25|TWO_SIDED|95.0|-30.5|24.55|||Mixed Models Analysis|||Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||24.55|-30.50|0.250
71664828|NCT02047734|142843191|SUPERIORITY||Rate Ratio|0.471||||0.0006|TWO_SIDED|95.0|0.306|0.725||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative Binomial Regression Model|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.725|0.306|0.0006
71664829|NCT02047734|142843191|SUPERIORITY||Rate Ratio|0.528||||0.003|TWO_SIDED|95.0|0.346|0.805||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Negative binomial regression model,|Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.|Rate ratio = Ozanimod / IFN β-1a|||0.805|0.346|0.0030
71777902|NCT00395733|143054923|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9458||||||90.0|0.8776|1.024|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||1.0240|0.8776|
71834401|NCT03363854|143172630|SUPERIORITY||Difference|0.3||||0.31|TWO_SIDED|95.0|-0.3|1.0||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 8 are reported below.||1.0|-0.3|0.31
71664830|NCT02047734|142843192|SUPERIORITY||Hazard Ratio (HR)|1.045||||0.8224|TWO_SIDED|95.0|0.711|1.537||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World) age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.537|0.711|0.8224
71664831|NCT02047734|142843192|SUPERIORITY||Hazard Ratio (HR)|0.798||||0.2849|TWO_SIDED|95.0|0.528|1.206||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazards model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.206|0.528|0.2849
71834402|NCT03363854|143172630|SUPERIORITY||Difference|1.0||||0.001|TWO_SIDED|95.0|0.4|1.6||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 9 are reported below.||1.6|0.4|0.001
71834403|NCT03363854|143172630|SUPERIORITY||Difference|0.7||||0.026|TWO_SIDED|95.0|0.1|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 10 are reported below.||1.3|0.1|0.026
71664832|NCT02047734|142843193|SUPERIORITY||Hazard Ratio (HR)|1.435||||0.1353|TWO_SIDED|95.0|0.893|2.305||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||2.305|0.893|0.1353
71664833|NCT02047734|142843193|SUPERIORITY||Hazard Ratio (HR)|1.098||||0.7154|TWO_SIDED|95.0|0.664|1.815||To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.|Cox proportional hazard model|Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score|Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.|||1.815|0.664|0.7154
71664834|NCT02047734|142843194|SUPERIORITY||Difference|9.4||||0.0047|TWO_SIDED|95.0|2.9|15.8|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||15.8|2.9|0.0047
71664835|NCT02047734|142843194|SUPERIORITY||Difference|7.1||||0.032|TWO_SIDED|95.0|0.6|13.6|||Cochran-Mantel-Haenszel|Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category||||13.6|0.6|0.0320
71664836|NCT02047734|142843195|SUPERIORITY||Difference|5.4||||0.0466|TWO_SIDED|95.0|0.0|10.8|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.8|0.0|0.0466
71664837|NCT02047734|142843195|SUPERIORITY||Difference|5.1||||0.0581|TWO_SIDED|95.0|-0.3|10.5|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category||||10.5|-0.3|0.0581
71664838|NCT02047734|142843196|SUPERIORITY||Difference in means|0.244|||<|0.0001|TWO_SIDED|95.0|0.125|0.363||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.363|0.125|<0.0001
71664839|NCT02047734|142843196|SUPERIORITY||Difference in means|0.224||||0.0002|TWO_SIDED|95.0|0.106|0.342||Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|ANCOVA||Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.|||0.342|0.106|0.0002
71664840|NCT02047734|142843197|SUPERIORITY||Difference in means|0.043||||0.248|TWO_SIDED|95.0|-0.03|0.116|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means are based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.116|-0.030|0.2480
71664841|NCT02047734|142843197|SUPERIORITY||Difference in means|0.093||||0.0123|TWO_SIDED|95.0|0.02|0.165|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.|||0.165|0.020|0.0123
71664842|NCT02047734|142843198|SUPERIORITY||Difference in means|1.345||||0.0988|TWO_SIDED|95.0|-0.252|2.943|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||2.943|-0.252|0.0988
71744700|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.739
71744701|NCT00452790|143000454|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744702|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71834404|NCT03363854|143172630|SUPERIORITY||Difference|0.9||||0.006|TWO_SIDED|95.0|0.2|1.5||The statistical test was not controlled for multiplicity.|Repeated measurements model]|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 11 are reported below.||1.5|0.2|0.006
71834405|NCT03363854|143172630|SUPERIORITY||Difference|0.6||||0.043|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 12 are reported below.||1.3|0.0|0.043
71664843|NCT02047734|142843198|SUPERIORITY||Difference in means|1.849||||0.0228|TWO_SIDED|95.0|0.258|3.44|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score.|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Physical Health Composite Summary Score||3.440|0.258|0.0228
71664844|NCT02047734|142843198|SUPERIORITY||Difference in means|0.38||||0.6997|TWO_SIDED|95.0|-1.553|2.313|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.313|-1.553|0.6997
71664845|NCT02047734|142843198|SUPERIORITY||Difference in means|0.587||||0.5501|TWO_SIDED|95.0|-1.339|2.513|||ANCOVA|Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and the Baseline summary score|Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.|Analysis of Mental Health Composite Summary Score||2.513|-1.339|0.5501
71664846|NCT02047734|142843200|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
71664847|NCT02047734|142843200|SUPERIORITY||||||<|0.0001|||||||Rank ANCOVA|Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline||||||<0.0001
71664848|NCT02952586|142843212|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9199|TWO_SIDED|95.0|0.928|1.573||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.573|0.928|0.9199
71664849|NCT02952586|142843213|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.9372|TWO_SIDED|95.0|0.927|1.849||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.849|0.927|0.9372
71744703|NCT00452790|143000454|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.446
71744704|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.625||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>=38 but \<=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.625
71664850|NCT02952586|142843215|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.9316|TWO_SIDED|95.0|0.93|1.694||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor (T) stage (\< T4 vs T4), Nodal (N) stage (N0 /N1/N2a/N2b vs N2c/N3), Human papillomavirus (HPV) status (Positive vs Negative).|Log Rank|||||1.694|0.930|0.9316
71664851|NCT02952586|142843216|SUPERIORITY||Odds Ratio (OR)|0.947||||0.6229|TWO_SIDED|95.0|0.663|1.352||The treatment arms were compared using a stratified, 1-sided, Cochran-Mantel-Haenszel Test. The 3 stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Cochran-Mantel-Haenszel|||||1.352|0.663|0.6229
71664852|NCT02952586|142843217|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.9061|TWO_SIDED|95.0|0.909|1.624||The treatment arms were compared using a stratified, 1-sided, log rank Test. The three stratification factors were tumor stage (\< T4 vs T4), Nodal stage (N0 /N1/N2a/N2b vs N2c/N3), HPV status (Positive vs Negative).|Log Rank|||||1.624|0.909|0.9061
71744705|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.375
71744706|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.624||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.624
71744707|NCT00452790|143000455|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744708|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.282||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.282
71744709|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.307||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.307
71813055|NCT01564368|143128443|SUPERIORITY||area under the curve|0.63|||<|0.001|ONE_SIDED|95.0||0.71||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV2 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.71||<0.001
71834406|NCT03363854|143172630|SUPERIORITY||Difference|0.8||||0.01|TWO_SIDED|95.0|0.2|1.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 13 are reported below.||1.4|0.2|0.010
71834407|NCT03363854|143172630|SUPERIORITY||Difference|0.7||||0.037|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 14 are reported below.||1.3|0.0|0.037
71834408|NCT03363854|143172630|SUPERIORITY||Difference|0.6||||0.045|TWO_SIDED|95.0|0.0|1.3||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 15 are reported below.||1.3|0.0|0.045
71834409|NCT03363854|143172630|SUPERIORITY||Difference|0.5||||0.17|TWO_SIDED|95.0|-0.2|1.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included. Results of Week 16 are reported below.||1.1|-0.2|0.17
71664853|NCT00789035|142843241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.74|-0.29||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 5mg minus placebo|||-0.29|-0.74|<0.0001
71664854|NCT00789035|142843241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.8|-0.35||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 10mg minus placebo|||-0.35|-0.80|<0.0001
71664855|NCT00789035|142843241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.94|-0.5||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 25mg minus placebo|||-0.50|-0.94|<0.0001
71664856|NCT00719615|142843257|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Only risk factors significant at the 0.10 level in univariate analysis were included in the multivariate model.|Fisher Exact|||Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.||||<0.05
71744710|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.939||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.939
71744711|NCT00452790|143000455|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
71744712|NCT00452790|143000456|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.111
71744713|NCT00452790|143000456|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71777903|NCT00395733|143054923|NON_INFERIORITY_OR_EQUIVALENCE|Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.8698||||||90.0|0.78|0.9657|||Fieller-type confidence interval||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.||0.9657|0.7800|
71777904|NCT01044706|143054937|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|108.46|STANDARD_ERROR_OF_MEAN|0.0321|<|0.05|TWO_SIDED|90.0|102.79|114.44||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 55|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.||114.44|102.79|<0.05
71777905|NCT01044706|143054938|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p\<0.05).|ratio of T/R geometric mean x 100|110.5|STANDARD_ERROR_OF_MEAN|0.0281|<|0.05|TWO_SIDED|95.0|105.43|115.82||Differences were declared statistically significant at the 5% level (p\<0.05).|ANOVA|degrees of freedom 56|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment\*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.||115.82|105.43|<0.05
71777906|NCT02913612|143054948|SUPERIORITY||Odds Ratio, log|2.65||||0.0205|TWO_SIDED|95.0|1.12|6.26|||Fisher Exact|||||6.26|1.12|0.0205
71777907|NCT02913612|143054948|SUPERIORITY||Odds Ratio, log|2.16||||0.0619|TWO_SIDED|95.0|0.91|5.14|||Fisher Exact|||||5.14|0.91|0.0619
71744714|NCT00452790|143000456|SUPERIORITY_OR_OTHER|||||||0.488||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.488
71777908|NCT02913612|143054948|SUPERIORITY||Odds Ratio, log|1.23||||0.6281|TWO_SIDED|95.0|0.53|2.82|||Fisher Exact|||||2.82|0.53|0.6281
71777909|NCT03452228|143054969|SUPERIORITY||Median Difference (Final Values)|-43.5|||||TWO_SIDED|95.0|-89.4|1238.9||||||||1238.9|-89.4|
71777910|NCT03452228|143054969|SUPERIORITY||Median Difference (Final Values)|-75.5|||||TWO_SIDED|95.0|-82.2|121.2||||||||121.2|-82.2|
71777911|NCT03319173|143055016|OTHER||Mean Difference (Final Values)|8.24|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|7.79|8.7|||Regression, Linear|||||8.7|7.79|<0.0001
71777912|NCT03319173|143055017|OTHER||Estimate|0.35|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.31|0.39|||Regression, Linear|||||0.39|0.31|<0.0001
71777913|NCT03319173|143055018|OTHER||Estimate|0.46|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.41|0.52|||Regression, Linear|||||0.52|0.41|<0.0001
71777914|NCT03319173|143055019|OTHER||Estimate|0.514|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
71777915|NCT03319173|143055020|OTHER||Estimate|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Regression, Linear|||||0.49|0.40|<0.0001
71777916|NCT03319173|143055021|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.4|0.49|||Estimate|||||0.49|0.40|<0.0001
71744715|NCT00452790|143000456|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.736
71664857|NCT00345943|142843273|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.|BN versus HC group effect|Growth curve models examined the following: group (BN versus HC) differences in cortical thickness (CT) at baseline; group differences in the rate of change in CT over time; and the persistence of group differences in CT over time.||||.03
71664858|NCT00345943|142843273|OTHER||Slope|0.053|STANDARD_ERROR_OF_MEAN|0.047|<|0.05|TWO_SIDED|95.0|-0.04|0.15|||Mixed Models Analysis|Growth curve models with between-within degrees of freedom and a random effect for the intercept and fixed effects for predictors.||Growth curve models examined the following: group (BN versus HC) differences in conflict-related BOLD signal at baseline; group differences in the rate of change in conflict-related BOLD signal over time; and the persistence of group differences in conflict-related BOLD signal over time.||0.15|-0.04|<.05
71664859|NCT00789737|142843277|SUPERIORITY_OR_OTHER|||||||0.0369||95.0|||||ANCOVA|||least squares mean; 80% power to detect a 0.3% change||||0.0369
71664860|NCT00789737|142843278|SUPERIORITY_OR_OTHER|||||||0.0373||95.0|||||ANCOVA|||||||0.0373
71664861|NCT00789737|142843283|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0|||||ANCOVA|||||||<0.00001
71664862|NCT00384930|142843290|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change = Endpoint minus Baseline.|Permutation Test|||This is the principal inferential analysis of the primary outcome.||||<0.001
71664863|NCT00384930|142843291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.025||95.0|-1.08|-0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.07|-1.08|0.025
71744716|NCT00452790|143000456|SUPERIORITY_OR_OTHER|||||||0.856||95.0|||||Fisher Exact|||Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.856
71664864|NCT00384930|142843291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.001||95.0|-1.4|-0.4||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.40|-1.40|<0.001
71664865|NCT00384930|142843291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|||<|0.001||95.0|-1.45|-0.46||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.46|-1.45|<0.001
71664866|NCT00384930|142843291|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07|||<|0.001||95.0|-1.58|-0.57||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.57|-1.58|<0.001
71664867|NCT00384930|142843292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.008||95.0|-1.69|-0.26||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.26|-1.69|0.008
71664868|NCT00384930|142843292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69|||<|0.001||95.0|-2.4|-0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.98|-2.40|<0.001
71664869|NCT00384930|142843292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89|||<|0.001||95.0|-2.6|-1.18||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-1.18|-2.60|<0.001
71664870|NCT00384930|142843292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.87|||<|0.001||95.0|-2.59|-1.15||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-1.15|-2.59|<0.001
71664871|NCT00384930|142843293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.503||95.0|-0.28|0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.14|-0.28|0.503
71664872|NCT00384930|142843293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.206||95.0|-0.34|0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||0.07|-0.34|0.206
71664873|NCT00384930|142843293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.452||95.0|-0.28|0.13||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||0.13|-0.28|0.452
71744717|NCT00452790|143000456|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.098
71744718|NCT00452790|143000456|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.034
71777917|NCT03319173|143055022|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.72|0.78|||Regression, Linear|||||0.78|0.72|<0.0001
71777918|NCT03319173|143055023|OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.3|0.37|||Estimate|||||0.37|0.30|<0.0001
71834410|NCT03363854|143172631|SUPERIORITY||Risk Difference (RD)|21.3|||<|0.001|TWO_SIDED|95.0|11.3|31.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||31.3|11.3|<0.001
71834411|NCT03363854|143172632|SUPERIORITY||Risk Difference (RD)|11.4||||0.022|TWO_SIDED|95.0|2.1|20.7||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their EASI value at Week 16.||20.7|2.1|0.022
71834412|NCT03363854|143172633|SUPERIORITY||Difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.7|-3.1||The statistical test was not controlled for multiplicity.|Repeated measurement model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-3.1|-7.7|<0.001
71744719|NCT00452790|143000456|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744720|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||0.085||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.085
71777919|NCT03319173|143055024|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
71777920|NCT03319173|143055025|OTHER||Estimate|0.87|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|0.85|0.88|||Regression, Linear|||||0.88|0.85|<0.0001
71777921|NCT03319173|143055026|OTHER||Estimate|0.75|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.71|0.8|||Regression, Linear|||||0.80|0.71|<0.0001
71777922|NCT03319173|143055027|OTHER||Estimate|0.51|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.47|0.56|||Regression, Linear|||||0.56|0.47|<0.0001
71777923|NCT03319173|143055028|OTHER||Estimate|1.13|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|1.104|1.156|||Regression, Linear|||||1.156|1.104|<0.0001
71777924|NCT03319173|143055029|OTHER||Estimate|1.037|||<|0.0001|TWO_SIDED|95.0|1.025|1.049|||Regression, Linear|||||1.049|1.025|<0.0001
71777925|NCT03319173|143055030|OTHER||Estimate|0.93|STANDARD_ERROR_OF_MEAN|0.008|<|0.0001|TWO_SIDED|95.0|0.91|0.94|||Regression, Linear|||||0.94|0.91|<0.0001
71777926|NCT03319173|143055031|OTHER||Estimate|1.122|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|1.096|1.149|||Regression, Linear|||||1.149|1.096|<0.0001
71664874|NCT00384930|142843293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.012||95.0|-0.47|-0.06||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.06|-0.47|0.012
71744721|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744722|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||0.489||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.489
71744723|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.840
71744724|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||0.605||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.605
71744725|NCT00452790|143000457|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71744726|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.265
71777927|NCT03673046|143055032|SUPERIORITY||Mean Difference (Final Values)|-10.1255|STANDARD_ERROR_OF_MEAN|1.5705|<|0.0001|TWO_SIDED|95.0|-13.2532|-6.9978||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-eeek waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BDD-YBOCS total scores between the treatment groups at endpoint (week 12).||-6.9978|-13.2532|<.0001
71777928|NCT03673046|143055033|SUPERIORITY||Mean Difference (Final Values)|-3.2648|STANDARD_ERROR_OF_MEAN|1.0346||0.0023|TWO_SIDED|95.0|-5.3275|-1.2022||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in QIDS-SR total scores between the treatment groups at endpoint (week 12).||-1.2022|-5.3275|0.0023
71777929|NCT03673046|143055034|SUPERIORITY||Mean Difference (Final Values)|-4.8412|STANDARD_ERROR_OF_MEAN|1.1195|<|0.0001|TWO_SIDED|95.0|-7.0698|-2.6126||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in BABS total scores between the treatment groups at endpoint (week 12).||-2.6126|-7.0698|<.0001
71777930|NCT03673046|143055035|SUPERIORITY||Mean Difference (Final Values)|-5.8847|STANDARD_ERROR_OF_MEAN|1.676||0.0008|TWO_SIDED|95.0|-9.2237|-2.5458||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an auto-correlation with heterogeneous variance (ARH(1)) covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in SDS total scores between the treatment groups at endpoint (week 12).||-2.5458|-9.2237|.0008
71777931|NCT03673046|143055036|SUPERIORITY||Mean Difference (Final Values)|11.7529|STANDARD_ERROR_OF_MEAN|3.4553||0.0011|TWO_SIDED|95.0|4.863|18.6428||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a compound symmetry with heterogeneous variance covariance matrix.|The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Q-LESQ-SF total scores between the treatment groups at endpoint (week 12).||18.6428|4.8630|.0011
71777932|NCT01896050|143055048|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients||||0.03
71744727|NCT00452790|143000457|SUPERIORITY_OR_OTHER|||||||0.422||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.422
71744728|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>= 38 but \<= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.815
71744729|NCT00452790|143000458|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>39 but \<= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||>0.99
71664875|NCT00384930|142843294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.029||95.0|-0.49|-0.03||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||-0.03|-0.49|0.029
71664876|NCT00384930|142843294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.002||95.0|-0.6|-0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.14|-0.60|0.002
71664877|NCT00384930|142843294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.43|||<|0.001||95.0|-0.66|-0.19||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.19|-0.66|<0.001
71744730|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||||95.0|||||Fisher Exact|||Difference in incidence rates of fever \>40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||
71744731|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||0.401||95.0|||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.401
71744732|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||0.511||95.0|||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.511
71744733|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||0.487||95.0|||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.487
71744734|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||0.388||95.0|||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.388
71664878|NCT00384930|142843294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001||95.0|-0.64|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-0.64|<0.001
71664879|NCT00384930|142843295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.583||95.0|-0.58|0.33||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.33|-0.58|0.583
71744735|NCT00452790|143000458|SUPERIORITY_OR_OTHER|||||||0.753||95.0|||||Fisher Exact|||Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.||||0.753
71777933|NCT01896050|143055048|SUPERIORITY_OR_OTHER||BMI squared|-0.01845|STANDARD_ERROR_OF_MEAN|0.02308||0.4262|TWO_SIDED||||||Regression, Linear|||Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.||||0.4262
71744736|NCT04437485|143000477|SUPERIORITY|||||||0.64|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.64
71744737|NCT04437485|143000478|SUPERIORITY|||||||0.046|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.046
71744738|NCT04437485|143000479|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models were run on post-treatment outcome level adjusting for baseline somatic depressive symptoms group (a stratification variable).||||||0.09
71744739|NCT05736874|143000619|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.91|
71777934|NCT01896050|143055049|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients||||0.032
71777935|NCT01896050|143055050|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.92|1.04||||||Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.||1.04|0.92|
71777936|NCT03693300|143055065|OTHER||Proportion (%)|6.1|||||TWO_SIDED|95.0|2.5|12.24|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||12.24|2.50|
71777937|NCT03693300|143055065|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||70.76|0.00|
71664880|NCT00384930|142843295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.013||95.0|-1.03|-0.12||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||-0.12|-1.03|0.013
71744740|NCT05736874|143000620|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||||Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||4.68|0.19|
71744741|NCT05736874|143000623|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|0.8|3.5|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||3.5|0.8|
71744742|NCT05736874|143000624|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.62|1.63|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.63|0.62|
71744743|NCT05736874|143000625|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.42|1.5|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||1.50|0.42|
71744744|NCT05736874|143000626|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors|Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|0.5|5.94|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||5.94|0.50|
71744745|NCT05736874|143000627|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.11|0.69|
71744746|NCT05736874|143000627|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.34|0.78|
71777938|NCT03693300|143055065|OTHER||Proportion (%)|6.0|||||TWO_SIDED|95.0|2.44|11.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related adverse events of CTCAE Grade 3 or Grade 4||11.94|2.44|
71777939|NCT03693300|143055065|OTHER||Proportion (%)|4.4|||||TWO_SIDED|95.0|1.44|9.94|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.94|1.44|
71744747|NCT05736874|143000627|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.45|0.78|
71744748|NCT05736874|143000627|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.79|1.53|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.53|0.79|
71744749|NCT05736874|143000628|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.09|0.72|
71744750|NCT05736874|143000628|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.84|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.27|0.84|
71744751|NCT05736874|143000628|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.20|0.76|
71777940|NCT03693300|143055065|OTHER||Proportion (%)|0.0|||||TWO_SIDED|95.0|0.0|70.76|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||70.76|0.00|
71777941|NCT03693300|143055065|OTHER||Proportion (%)|4.3|||||TWO_SIDED|95.0|1.4|9.69|||||95% CI were based on the Clopper-Pearson method.|Any possibly related AEs of Grade 3 or Grade 4 with onset date within 6 months of the first dose||9.69|1.40|
71777942|NCT02495831|143055113|SUPERIORITY_OR_OTHER||point estimate (ratio of geometric means|90.0||||0.1|TWO_SIDED|90.0|80.0|125.0||If the upper limit of the 90% confidence interval is \< 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).|ANOVA|||The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.||125|80|0.1
71777943|NCT02495831|143055114|SUPERIORITY_OR_OTHER||geometric mean ratio|104.84|||||TWO_SIDED|90.0|96.4|114.02||||||||114.02|96.40|
71777944|NCT03789396|143055118|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Logistic|||Comparison of patient odds of being hyperoxic and not on room air pre- versus post-intervention||0.97|0.57|0.03
71777945|NCT02281773|143055141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1256|TWO_SIDED|95.0|-2.76|0.34||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.34|-2.76|0.1256
71834413|NCT03363854|143172634|SUPERIORITY||Risk Difference (RD)|22.9|||<|0.001|TWO_SIDED|95.0|12.4|33.3||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Partcipants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||33.3|12.4|<0.001
71834414|NCT03363854|143172635|SUPERIORITY||Risk Difference (RD)|11.1||||0.012|TWO_SIDED|95.0|3.2|19.0||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their SCORAD value at Week 16.||19.0|3.2|0.012
71664881|NCT00384930|142843295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.016||95.0|-1.0|-0.1||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||-0.10|-1.00|0.016
71664882|NCT00384930|142843295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.007||95.0|-1.08|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||-0.17|-1.08|0.007
71834415|NCT03363854|143172636|SUPERIORITY||Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.7||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of investigational medicinal product or initiation of rescue medication were not included.||-0.7|-1.7|<0.001
71834416|NCT03363854|143172637|SUPERIORITY||Risk Difference (RD)|17.6|||<|0.001|TWO_SIDED|95.0|8.0|27.1||The statistical test was not controlled for multiplicity.|Cochran-Mantel-Haenszel|The analysis was conducted using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||Participants meeting the endpoint were defined as responders. Participants with missing data at Week 16 or who received rescue medication prior to Week 16 were defined as non-responders, independently of their DLQI value at Week 16.||27.1|8.0|<0.001
71834417|NCT01903811|143172651|SUPERIORITY||Hazard Ratio (HR)|1.061||||0.384|TWO_SIDED|80.0|0.821|1.37||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.370|0.821|0.384
71664883|NCT00384930|142843296|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.133
71777946|NCT02281773|143055141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.8||0.7337|TWO_SIDED|95.0|-1.3|1.84||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.84|-1.30|0.7337
71777947|NCT02281773|143055141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6994|TWO_SIDED|95.0|-1.31|1.95||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||1.95|-1.31|0.6994
71744752|NCT05736874|143000628|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.32|0.84|
71777948|NCT02281773|143055141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.79||0.427|TWO_SIDED|95.0|-2.19|0.93||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward-Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.||0.93|-2.19|0.4270
71777949|NCT02281773|143055146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.66||0.5972|TWO_SIDED|95.0|-0.9|1.6||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.6|-0.9|0.5972
71777950|NCT02281773|143055146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3817|TWO_SIDED|95.0|-1.9|0.7||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.7|-1.9|0.3817
71777951|NCT02281773|143055146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68||0.48|TWO_SIDED|95.0|-0.9|1.8||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.8|-0.9|0.4800
71777952|NCT02281773|143055146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7507|TWO_SIDED|95.0|-1.1|1.5||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.5|-1.1|0.7507
71777953|NCT02281773|143055147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9399|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9399
71834418|NCT01903811|143172652|SUPERIORITY||Hazard Ratio (HR)|1.149||||0.284|TWO_SIDED|80.0|0.841|1.571||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test||||1.571|0.841|0.284
71744753|NCT05736874|143000629|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.58|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.58|
71834419|NCT01903811|143172653|SUPERIORITY|||||||0.113|||||||Cochran-Mantel-Haenszel|||Compare the rate of confirmed PR or better between treatment arms.||||0.1130
71834420|NCT01704079|143172733|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71834421|NCT01704079|143172734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71834422|NCT01704079|143172735|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71834423|NCT01704079|143172736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71834424|NCT05986565|143172772|SUPERIORITY|||||||0.587|||||||RMANOVA|1||||||0.587
71834425|NCT05986565|143172773|SUPERIORITY|||||||0.874|||||||RMANOVA|1||||||0.874
71834426|NCT05986565|143172774|SUPERIORITY|||||||0.946|||||||RMANOVA|1||||||0.946
71834427|NCT05986565|143172775|SUPERIORITY|||||||0.267|||||||t-test, 2 sided|24||||||0.267
71834428|NCT05986565|143172776|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|df=25||||||0.187
71744754|NCT05736874|143000629|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.32|0.76|
71744755|NCT05736874|143000629|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.71|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.25|0.71|
71744756|NCT05736874|143000629|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.89|1.64|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.64|0.89|
71744757|NCT05736874|143000630|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.15|0.70|
71777954|NCT02281773|143055147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9919|TWO_SIDED|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.1|-0.1|0.9919
71777955|NCT02281773|143055147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3027|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3027
71777956|NCT02281773|143055147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.3901|TWO_SIDED|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between-group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.||0.2|-0.1|0.3901
71777957|NCT02899299|143055195|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.002|TWO_SIDED|96.6|0.6|0.91||Boundary for statistical significance was a p-value \< 0.0345|Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.91|0.60|0.0020
71777958|NCT02899299|143055198|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.77|1.13|||||Stratified Cox proportional hazard model|||1.13|0.77|
71777959|NCT02899299|143055199|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||\<1% PD-L1||1.32|0.64|
71777960|NCT02899299|143055199|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.88||||||≥1% PD-L1||0.88|0.59|
71834429|NCT05986565|143172777|SUPERIORITY|||||||0.765|||||||t-test, 2 sided|df=24||||||0.765
71834430|NCT05986565|143172778|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|df=25||||||0.060
71834431|NCT05986565|143172779|SUPERIORITY|||||||0.608|||||||t-test, 2 sided|df=24||||||0.608
71834432|NCT05986565|143172780|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|df=25||||||0.638
71834433|NCT04500301|143172785|OTHER|No statistical test was performed.|Proportion|0.136|||||TWO_SIDED|95.0|0.054|0.219|||||The Wald 95% confidence interval for the binomial proportion was estimated.|No hypothesis was tested with regard to the primary outcome. The study planned to enroll 80 eligible subjects such that at least 65 would be evaluable for the primary outcome and the width of the 95% Clopper-Pearson confidence interval for the proportion would be less than or equal to .25.||0.219|0.054|
71744758|NCT05736874|143000630|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.75|
71744759|NCT05736874|143000630|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.26|0.72|
71834434|NCT00792636|143172808|SUPERIORITY_OR_OTHER||Least-squares mean|-1.7|||||TWO_SIDED|95.0|-3.2|-0.3|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-3.2|
71664884|NCT00384930|142843296|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.003
71664885|NCT00384930|142843296|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
71744760|NCT05736874|143000630|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.92|1.61|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.61|0.92|
71664886|NCT00384930|142843296|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|||||||<0.001
71664887|NCT00384930|142843297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.735||95.0|-0.69|0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||0.98|-0.69|0.735
71664888|NCT00384930|142843297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.355||95.0|-0.44|1.23||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||1.23|-0.44|0.355
71664889|NCT00384930|142843297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.433||95.0|-0.5|1.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||1.17|-0.50|0.433
71664890|NCT00384930|142843297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.089||95.0|-0.11|1.59||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||1.59|-0.11|0.089
71664891|NCT00384930|142843298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.36|||<|0.001||95.0|1.56|5.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|||5.17|1.56|<0.001
71777961|NCT02899299|143055200|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|1.79|||||TWO_SIDED|95.0|1.22|2.63||||||\< 1% PD-L1||2.63|1.22|
71777962|NCT02899299|143055200|SUPERIORITY|Treatment A vs Treatment B|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||≥1% PD-L1||0.96|0.61|
71777963|NCT02899299|143055202|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.62|0.88|||Stratified Log Rank|This is 2 sided p-value from log-rank test stratified by histology and sex as entered in the IRT|Stratified Cox proportional hazard model|||0.88|0.62|0.0008
71777964|NCT00313300|143055203|SUPERIORITY_OR_OTHER||Adjusted rate difference|2.2|||||TWO_SIDED|95.0|-1.0|5.4|||||adjusted difference of event rates takes into consideration stratification factors.|||5.4|-1.0|
71664892|NCT00384930|142843298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|||<|0.001||95.0|2.95|6.54||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|||6.54|2.95|<0.001
71664893|NCT00384930|142843298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.83|||<|0.001||95.0|4.04|7.62||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|||7.62|4.04|<0.001
71664894|NCT00384930|142843298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.15|||<|0.001||95.0|4.35|7.95||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|||7.95|4.35|<0.001
71664895|NCT00384930|142843299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58||||0.005||95.0|-2.68|-0.48||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-0.48|-2.68|0.005
71777965|NCT00313300|143055203|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|3.8|||||TWO_SIDED|95.0|0.4|7.3|||||adjusted difference of event rates takes into consideration stratification factors.|||7.3|0.4|
71777966|NCT00313300|143055204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.44|1.19||||||||1.19|0.44|
71777967|NCT00313300|143055204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.35|1.04||||||||1.04|0.35|
71777968|NCT00313300|143055205|SUPERIORITY_OR_OTHER||Adjusted rate difference|6.6|||||TWO_SIDED|95.0|1.8|11.3|||||adjusted difference of event rates takes into consideration stratification factors.|||11.3|1.8|
71777969|NCT00313300|143055205|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.0|||||TWO_SIDED|95.0|4.8|15.2|||||adjusted difference of event rates takes into consideration stratification factors.|||15.2|4.8|
71777970|NCT00313300|143055206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.44|1.17||||||||1.17|0.44|
71777971|NCT00313300|143055206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.37|1.07||||||||1.07|0.37|
71664896|NCT00384930|142843299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|||<|0.001||95.0|-3.69|-1.51||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.51|-3.69|<0.001
71664897|NCT00384930|142843299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|||<|0.001||95.0|-3.99|-1.81||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.81|-3.99|<0.001
71664898|NCT00384930|142843299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.94|||<|0.001||95.0|-4.04|-1.84||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.||-1.84|-4.04|<0.001
71664899|NCT03968978|142843301|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.5|93.67|
71744761|NCT05736874|143000631|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.81|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.28|0.81|
71744762|NCT05736874|143000631|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.6|0.99|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||0.99|0.60|
71777972|NCT00313300|143055207|SUPERIORITY_OR_OTHER||Adjusted rate difference|0.3|||||TWO_SIDED|95.0|-1.3|2.0|||||adjusted difference of event rates takes into consideration stratification factors.|||2.0|-1.3|
71777973|NCT00313300|143055207|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||adjusted difference of event rates takes into consideration stratification factors.|||2.7|-1.1|
71777974|NCT00313300|143055208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
71834435|NCT00792636|143172808|SUPERIORITY_OR_OTHER||Least-squares mean|-0.9|||||TWO_SIDED|95.0|-2.2|0.3|||||Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.3|-2.2|
71777975|NCT00313300|143055208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
71777976|NCT00313300|143055208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
71777977|NCT00313300|143055208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
71777978|NCT00313300|143055209|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.0|||||TWO_SIDED|95.0|0.0|8.1||||||||8.1|0.0|
71664900|NCT03968978|142843301|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100|96.65|
71664901|NCT03968978|142843301|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
71664902|NCT03968978|142843301|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
71664903|NCT03968978|142843301|OTHER||Proportion|95.4|||||TWO_SIDED|95.0|89.71|98.02|||Score CI|CI for Week 16 (at home)||||98.02|89.71|
71664904|NCT03968978|142843301|OTHER||Proportion|96.3|||||TWO_SIDED|95.0|90.94|98.56|||Score CI|CI for Week 20 (in clinic)||||98.56|90.94|
71664905|NCT03968978|142843301|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.47|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.47|
71664906|NCT03968978|142843301|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 4 (in clinic)||||99.02|91.93|
71664907|NCT03968978|142843301|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Score CI|CI for Week 8 (in clinic)||||99.48|93.32|
71664908|NCT03968978|142843301|OTHER||Proportion|99.0|||||TWO_SIDED|95.0|94.8|99.83|||Score CI|CI for week 12 (at home)||||99.83|94.80|
71744763|NCT05736874|143000631|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.74|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.23|0.74|
71744764|NCT05736874|143000631|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.50|0.89|
71777979|NCT00313300|143055209|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|0.0|9.3||||||||9.3|0.0|
71777980|NCT00313300|143055209|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|7.0|||||TWO_SIDED|95.0|3.4|10.5||||||||10.5|3.4|
71777981|NCT00313300|143055209|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.7|||||TWO_SIDED|95.0|1.4|8.0||||||||8.0|1.4|
71777982|NCT00313300|143055210|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|8.3|||||TWO_SIDED|95.0|1.8|14.9||||||||14.9|1.8|
71777983|NCT00313300|143055210|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.9|||||TWO_SIDED|95.0|3.4|18.4||||||||18.4|3.4|
71777984|NCT00313300|143055210|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|17.4|||||TWO_SIDED|95.0|11.6|23.2||||||||23.2|11.6|
71777985|NCT00313300|143055210|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|10.4|||||TWO_SIDED|95.0|5.6|15.1||||||||15.1|5.6|
71777986|NCT00313300|143055211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.44|2.88||||||||2.88|0.44|
71777987|NCT00313300|143055211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.29|2.57||||||||2.57|0.29|
71777988|NCT00313300|143055211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.71|||||TWO_SIDED|95.0|0.3|1.66||||||||1.66|0.30|
71744765|NCT05736874|143000632|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.69|1.06|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.06|0.69|
71744766|NCT05736874|143000632|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.82|1.3|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.30|0.82|
71744767|NCT05736874|143000632|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.32|0.80|
71744768|NCT05736874|143000632|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.75|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.29|0.75|
71744769|NCT05736874|143000633|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.62|0.93|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||0.93|0.62|
71744770|NCT05736874|143000633|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.78|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.18|0.78|
71744771|NCT05736874|143000633|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.74|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.12|0.74|
71777989|NCT00313300|143055211|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.3|1.74||||||||1.74|0.30|
71777990|NCT00313300|143055212|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|0.8|||||TWO_SIDED|95.0|-0.9|2.6||||||||2.6|-0.9|
71777991|NCT00313300|143055212|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|2.9|||||TWO_SIDED|95.0|0.6|5.1||||||||5.1|0.6|
71664909|NCT03968978|142843301|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 16 (at home)||||99.02|91.93|
71744772|NCT05736874|143000633|OTHER|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.|Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.02|1.56|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.56|1.02|
71744773|NCT05736874|143000634|SUPERIORITY||Difference in model estimate time unwell|-0.1|||||TWO_SIDED|95.0|-0.45|0.26|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.26|-0.45|
71744774|NCT05736874|143000635|SUPERIORITY||Difference in model estimated means|0.13|||||TWO_SIDED|95.0|-0.28|0.58|||||The interval is a highest-density credible interval.|Secondary endpoints were not used for formal decision making; there was no decision threshold. No formal hypothesis test was performed.||0.58|-0.28|
71744775|NCT03057496|143000656|SUPERIORITY||Rate ratio|0.627|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.536|0.734||Since the outcome (contacts) represented over-dispersed count data and there were repeated measurements per subject, a generalized mixed effects model with a negative binomial family was used with each subject treated as a random intercept.|Mixed Models Analysis|Fixed factors were included in the model to account for factors other than device operating mode that might affect collision rates.|Silent mode is the denominator for the rate ratio.|A within-subject comparison was performed. Each subject included in the analysis used the device in both the active and the silent mode. Comparison was between the two device operating modes. The null hypothesis was that there was no difference in the rate of contacts between active and silent modes.||0.734|0.536|< 0.001
71744776|NCT03270943|143000660|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
71744777|NCT03270943|143000661|OTHER|within group|Mean Difference (Net)|-1.01|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-6.06|3.84|||||Difference between score at 8 weeks and score at baseline.|||3.84|-6.06|
71744778|NCT03270943|143000661|OTHER|within group|Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-8.7|-0.22|||||Difference between score at 8 weeks and score at baseline.|||-0.22|-8.70|
71744779|NCT03270943|143000662|OTHER|within group change|Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.72|0.2|||||Difference between score at 8 weeks and score at baseline.|||0.2|-2.72|
71777992|NCT00313300|143055212|SUPERIORITY_OR_OTHER||Adjusted Rate Difference|4.1|||||TWO_SIDED|95.0|1.3|6.9||||||||6.9|1.3|
71777993|NCT02468232|143055246|SUPERIORITY||Hazard Ratio (HR)|1.0881||||0.626|TWO_SIDED|95.0|0.6501|1.8212|||Regression, Cox|||For Primary Composite||1.8212|0.6501|0.6260
71777994|NCT02468232|143055246|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||For CV Death||2.6122|0.5242|0.6493
71777995|NCT02468232|143055246|SUPERIORITY||Hazard Ratio (HR)|1.2673||||0.7851|TWO_SIDED|95.0|0.7039|2.2818|||Regression, Cox|||For 1st HF Hospitalization||2.2818|0.7039|0.7851
71744780|NCT03270943|143000662|OTHER|within group change|Mean Difference (Net)|-1.72|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-3.6|0.16|||||Difference between score at 8 weeks and score at baseline.|||0.16|-3.60|
71744781|NCT03270943|143000663|OTHER|Within group change|Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.15|0.61|||||Difference between score at 8 weeks and score at baseline.|||0.61|-0.15|
71744782|NCT03270943|143000663|OTHER|within group change|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.07|0.63|||||Difference between score at 8 weeks and score at baseline.|||0.63|0.07|
71744783|NCT02981368|143000680|SUPERIORITY|||||||0.1097|||||||Fisher Exact|||Tissue Site: Bone||||0.1097
71744784|NCT02981368|143000680|SUPERIORITY|||||||0.1087|||||||Fisher Exact|||Tissue Site: Bone||||0.1087
71744785|NCT02981368|143000680|SUPERIORITY|||||||0.1949|||||||Fisher Exact|||Tissue Site: Bone||||0.1949
71777996|NCT02468232|143055247|SUPERIORITY||LSM of ratio|0.8657||||0.0326|TWO_SIDED|95.0|0.7585|0.988||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 4 analysis||0.9880|0.7585|0.0326
71777997|NCT02468232|143055247|SUPERIORITY||LSM of ratio|0.8538||||0.0161|TWO_SIDED|95.0|0.7509|0.9708||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||0.9708|0.7509|0.0161
71664910|NCT03968978|142843301|OTHER||Proportion|97.1|||||TWO_SIDED|95.0|91.93|99.02|||Score CI|CI for Week 20 (in clinic)||||99.02|91.93|
71744786|NCT02981368|143000680|SUPERIORITY|||||||0.1315|||||||Fisher Exact|||Tissue Site: Bone||||0.1315
71744787|NCT02981368|143000680|SUPERIORITY|||||||0.1977|||||||Fisher Exact|||Tissue Site: Bone||||0.1977
71744788|NCT02981368|143000680|SUPERIORITY|||||||0.2149|||||||Fisher Exact|||Tissue Site: Bone||||0.2149
71744789|NCT02981368|143000680|SUPERIORITY|||||||0.2582|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2582
71777998|NCT02468232|143055247|SUPERIORITY||LSM of ratio|0.8112||||0.0104|TWO_SIDED|95.0|0.6916|0.9514||Indicates statistical significance (2-sided) with an alpha level of 0.05|ANCOVA|Repeated measure of ANCOVA model||Month 6 analysis||0.9514|0.6916|0.0104
71777999|NCT02468232|143055249|SUPERIORITY||Hazard Ratio (HR)|1.024||||0.5406|TWO_SIDED|95.0|0.6492|1.6152|||Regression, Cox|||First triple composite endpoint||1.6152|0.6492|0.5406
71778000|NCT02468232|143055249|SUPERIORITY||Hazard Ratio (HR)|1.1701||||0.6493|TWO_SIDED|95.0|0.5242|2.6122|||Regression, Cox|||CV health||2.6122|0.5242|0.6493
71744790|NCT02981368|143000680|SUPERIORITY|||||||0.0009|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.0009
71744791|NCT02981368|143000680|SUPERIORITY|||||||0.3588|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.3588
71744792|NCT02981368|143000680|SUPERIORITY|||||||0.8791|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.8791
71744793|NCT02981368|143000680|SUPERIORITY|||||||0.9457|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.9457
71744794|NCT02981368|143000680|SUPERIORITY|||||||0.2705|||||||Fisher Exact|||Tissue Site: Visceral/Soft tissue||||0.2705
71744795|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
71744796|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
71744797|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Type: Lymph nodes||||<0.0001
71744798|NCT02981368|143000680|SUPERIORITY|||||||0.5933|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5933
71744799|NCT02981368|143000680|SUPERIORITY|||||||0.7094|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.7094
71744800|NCT02981368|143000680|SUPERIORITY|||||||0.5424|||||||Chi-squared|||Tissue Type: Lymph nodes||||0.5424
71744801|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: Prostate Gland||||<0.0001
71744802|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
71744803|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Tissue Site: Prostate Gland||||<0.0001
71744804|NCT02981368|143000680|SUPERIORITY|||||||0.0038|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0038
71744805|NCT02981368|143000680|SUPERIORITY|||||||0.0647|||||||Fisher Exact|||Tissue Site: Prostate Gland||||0.0647
71744806|NCT02981368|143000680|SUPERIORITY|||||||0.0021|||||||Chi-squared|||Tissue Site: Prostate Gland||||0.0021
71744807|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
71744808|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
71744809|NCT02981368|143000680|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Tissue Site: All||||<0.0001
71744810|NCT02981368|143000680|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Tissue Site: All||||0.0815
71744811|NCT02981368|143000680|SUPERIORITY|||||||0.7507|||||||Chi-squared|||Tissue Site: All||||0.7507
71744812|NCT02981368|143000680|SUPERIORITY|||||||0.562|||||||Chi-squared|||Tissue Site: All||||0.5620
71744813|NCT01584232|143000709|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to insulin glargine.|LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.67|-0.41||P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).|Mixed Models Analysis|||Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.||-0.41|-0.67|<0.001
71744814|NCT01584232|143000710|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<=6.5%.|Regression, Logistic|||||||<0.001
71744815|NCT01584232|143000710|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c \<7%.|Regression, Logistic|||||||<0.001
71744816|NCT01584232|143000711|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.183|TWO_SIDED|95.0|-1.7|8.7|||Mixed Models Analysis|||||8.7|-1.7|0.183
71778001|NCT02468232|143055249|SUPERIORITY||Hazard Ratio (HR)|0.8546||||0.3448|TWO_SIDED|95.0|0.3952|1.8479|||Regression, Cox|||First worsening of HF in outpatient||1.8479|0.3952|0.3448
71778002|NCT02468232|143055250|SUPERIORITY|||||||0.7115|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 4 analysis||||0.7115
71778003|NCT02468232|143055250|SUPERIORITY|||||||0.1752|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Week 8 analysis||||0.1752
71744817|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16||||0.022|TWO_SIDED|95.0|0.76|9.56||Treatment comparison for pre-morning meal.|ANCOVA|||||9.56|0.76|0.022
71664911|NCT03968978|142843302|OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.67|99.5|||Score CI|CI at Week 0 (in clinic)||||99.50|93.67|
71664912|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.65|100.0|||Score CI|CI at Week 4 (in clinic)||||100.00|96.65|
71744818|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.4||||0.003|TWO_SIDED|95.0|-22.28|-4.52||Treatment comparison for 2 hours post-morning meal.|ANCOVA|||||-4.52|-22.28|0.003
71744819|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.22||||0.025|TWO_SIDED|95.0|-15.37|-1.06||Treatment comparison for pre-midday meal.|ANCOVA|||||-1.06|-15.37|0.025
71744820|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.22|||<|0.001|TWO_SIDED|95.0|-31.92|-14.51||Treatment comparison for 2 hours post-midday meal.|ANCOVA|||||-14.51|-31.92|<0.001
71744821|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|||<|0.001|TWO_SIDED|95.0|-21.03|-6.24||Treatment comparison for pre-evening meal.|ANCOVA|||||-6.24|-21.03|<0.001
71744822|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.13|||<|0.001|TWO_SIDED|95.0|-39.26|-23.0||Treatment comparison for 2 hours post-evening meal.|ANCOVA|||||-23.00|-39.26|<0.001
71778004|NCT02468232|143055250|SUPERIORITY|||||||0.2688|||||||Cochran-Mantel-Haenszel|based on modified ridit scores||Month 6 analysis||||0.2688
71664913|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 8 (in clinic)||||100.00|96.63|
71664914|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.63|100.0|||Score CI|CI for Week 12 (at home)||||100.00|96.63|
71664915|NCT03968978|142843302|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|92.8|99.04|||Score CI|CI for Week 16 (at home)||||99.04|92.80|
71664916|NCT03968978|142843302|OTHER||Proportion|99.1|||||TWO_SIDED|95.0|94.85|99.83|||Score CI|CI for Week 20 (in clinic)||||99.83|94.85|
71664917|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.46|100.0|||Score CI|CI for Week 0 (in clinic)||||100.00|96.46|
71664918|NCT03968978|142843302|OTHER||Proportion|97.2|||||TWO_SIDED|95.0|93.38|99.48|||Score CI|CI for Week 4 (in clinic)||||99.48|93.38|
71664919|NCT03968978|142843302|OTHER||Proportion|98.1|||||TWO_SIDED|95.0|93.32|99.48|||Other CI|CI for Week 8 (in clinic)||||99.48|93.32|
71664920|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.44|100.0|||Score CI|CI for week 12 (at home)||||100.00|96.44|
71744823|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.73|||<|0.001|TWO_SIDED|95.0|-31.68|-15.79||Treatment comparison for bedtime.|ANCOVA|||||-15.79|-31.68|<0.001
71744824|NCT01584232|143000712|SUPERIORITY_OR_OTHER||LS Mean Difference|6.21||||0.005|TWO_SIDED|95.0|1.92|10.5||Treatment comparison for second pre-morning meal.|ANCOVA|||||10.50|1.92|0.005
71744825|NCT01584232|143000713|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.89|-0.94|||Mixed Models Analysis|||||-0.94|-1.89|<0.001
71744826|NCT01584232|143000714|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71744827|NCT01307319|143000715|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.63|||<|0.001|TWO_SIDED|95.0|-1.0|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.3|-1.0|<0.001
71744828|NCT01307319|143000715|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
71744829|NCT01307319|143000716|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.3||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||The power calculation assumed the standard deviation (SD) for the change from baseline over two weeks in the average of AM and PM reflective TNSS is assumed to be 2.0. Using this standard deviation, 235 subjects per arm provides 90% power to detect a difference of 0.60 in TNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.||-0.3|-1.1|<0.001
71744830|NCT01307319|143000716|SUPERIORITY_OR_OTHER||LSM treatment difference from placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4||a priori statistical significance is \<0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.4|-1.1|<0.001
71744831|NCT00790192|143000768|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71744832|NCT00790192|143000769|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71744833|NCT01544920|143000795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.|Difference in SVR24% in Arm 2 vs. Arm 1|1.7|||||TWO_SIDED|95.0|-3.2|6.5||||||Difference in percentage of participants achieving SVR24||6.5|-3.2|
71744834|NCT01544920|143000796|NON_INFERIORITY_OR_EQUIVALENCE|The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.|Difference in SVR24%|10.3|||||TWO_SIDED|95.0|2.5|18.1||||||||18.1|2.5|
71744835|NCT00466440|143000797|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||1|TWO_SIDED|90.0|-12.52|12.95|||Chi-squared||The objective response rates and the 90% confidence intervals were estimated for the qualified participants using unadjusted normal approximation for binomial proportions (z approximation).|||12.95|-12.52|1.0000
71744836|NCT00466440|143000798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6||||0.3606|TWO_SIDED|90.0|-28.21|4.95|||Chi-squared|||||4.95|-28.21|0.3606
71744837|NCT00466440|143000799|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.072|TWO_SIDED|90.0|-0.02|0.55|||t-test, 1 sided|||||0.55|-0.02|0.0720
71744838|NCT00466440|143000800|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15||||0.1697|TWO_SIDED|90.0|-0.07|0.37|||t-test, 1 sided|||||0.37|-0.07|0.1697
71778005|NCT02468232|143055251|SUPERIORITY||LSM of difference|2.5455||||0.1854|TWO_SIDED|95.0|-1.2306|6.3216|||ANCOVA|Repeated measure ANCOVA model||Week 8 analysis||6.3216|-1.2306|0.1854
71664921|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 16 (at home)||||100.00|96.37|
71664922|NCT03968978|142843302|OTHER||Proportion|100.0|||||TWO_SIDED|95.0|96.37|100.0|||Score CI|CI for Week 20 (in clinic)||||100.00|96.37|
71664923|NCT03968978|142843303|OTHER||Proportion|1.8|||||TWO_SIDED|95.0|0.5|6.33|||Score CI|CI at Week 0 (in clinic)||||6.33|0.50|
71664924|NCT03968978|142843303|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.35|||Score CI|CI at Week 4 (in clinic)||||3.35|0|
71664925|NCT03968978|142843303|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 8 (in clinic)||||3.37|0|
71664926|NCT03968978|142843303|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.37|||Score CI|CI for Week 12 (at home)||||3.37|0|
71664927|NCT03968978|142843303|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.96|7.92|||Score CI|CI for Week 16 (at home)||||7.92|0.96|
71744839|NCT00466440|143000801|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.524|TWO_SIDED|95.0|0.5|1.4|||Log Rank|||||1.4|0.5|0.5240
71744840|NCT00466440|143000802|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.4407|TWO_SIDED|95.0|0.3|1.6|||Log Rank|||||1.6|0.3|0.4407
71744841|NCT00466440|143000803|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.3449|TWO_SIDED|95.0|0.4|1.4|||Log Rank|||||1.4|0.4|0.3449
71778006|NCT02468232|143055251|SUPERIORITY||LSM of difference|1.2695||||0.5737|TWO_SIDED|95.0|-3.1715|5.7104|||ANCOVA|Repeated measure ANCOVA model||Month 6 analysis||5.7104|-3.1715|0.5737
71778007|NCT02468232|143055252|SUPERIORITY||rate ratio|0.8699||||0.6501||95.0|0.4763|1.5887|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.5887|0.4763|0.6501
71778008|NCT02468232|143055253|SUPERIORITY|||||||0.6211|||||||Cochran-Mantel-Haenszel|||||||0.6211
71778009|NCT02468232|143055255|SUPERIORITY||Hazard Ratio (HR)|1.1895||||0.6955|TWO_SIDED|95.0|0.6116|2.3134|||Regression, Cox|||||2.3134|0.6116|0.6955
71664928|NCT03968978|142843303|OTHER||Proportion|0.9|||||TWO_SIDED|95.0|0.17|5.15|||Score CI|CI for Week 20 (in clinic)||||5.15|0.17|
71664929|NCT03968978|142843303|SUPERIORITY||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.53|||Score CI|CI for Week 0 (in clinic)||||3.53|0|
71778010|NCT02468232|143055257|SUPERIORITY||Rate ratio|1.0192||||0.9233|TWO_SIDED|95.0|0.6925|1.4999|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.4999|0.6925|0.9233
71664930|NCT03968978|142843303|OTHER||Proportion|2.8|||||TWO_SIDED|95.0|0.97|7.99|||Score CI|CI for Week 4 (in clinic)||||7.99|0.97|
71664931|NCT03968978|142843303|OTHER||Proportion|1.9|||||TWO_SIDED|95.0|0.52|6.68|||Other CI|CI for Week 8 (in clinic)||||6.68|0.52|
71664932|NCT03968978|142843303|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.56|||Score CI|CI for week 12 (at home)||||3.56|0|
71664933|NCT03968978|142843303|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 16 (at home)||||3.63|0|
71664934|NCT03968978|142843303|OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|3.63|||Score CI|CI for Week 20 (in clinic)||||3.63|0|
71664935|NCT00863772|142843334|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.37||0.434|TWO_SIDED|95.0|-0.44|1.01|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||1.01|-0.44|0.434
71664936|NCT00863772|142843334|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.37||0.883|TWO_SIDED|95.0|-0.68|0.79|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.79|-0.68|0.883
71664937|NCT00863772|142843335|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.37||0.72|TWO_SIDED|95.0|-0.59|0.86|||ANCOVA|||Analysis of co-variance (ANCOVA) model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.86|-0.59|0.720
71744842|NCT00411749|143000814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71744843|NCT00411749|143000815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71744844|NCT00411749|143000816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71744845|NCT00411749|143000817|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71744846|NCT00411749|143000818|SUPERIORITY_OR_OTHER||Geometric Mean|155.2|||||TWO_SIDED|95.0|126.2|190.9||||||||190.9|126.2|
71744847|NCT00411749|143000818|SUPERIORITY_OR_OTHER||Geometric Mean|198.2|||||TWO_SIDED|95.0|160.9|244.2||||||||244.2|160.9|
71744848|NCT00411749|143000818|SUPERIORITY_OR_OTHER||Geometric Mean|617.1|||||TWO_SIDED|95.0|491.7|774.5||||||||774.5|491.7|
71744849|NCT00411749|143000818|SUPERIORITY_OR_OTHER||Geometric Mean|90.0|||||TWO_SIDED|95.0|68.8|117.8||||||||117.8|68.8|
71744850|NCT00964496|143000828|SUPERIORITY_OR_OTHER||Differences in proportions|0.677||||1.3e-07|TWO_SIDED|95.0|0.547|0.807||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.807|0.547|0.00000013
71778011|NCT02468232|143055258|SUPERIORITY||Rate ratio|1.0754||||0.9272|TWO_SIDED|95.0|0.2264|5.1067|||Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||5.1067|0.2264|0.9272
71778012|NCT02468232|143055260|SUPERIORITY||Rate ratio|0.4504||||0.0697|TWO_SIDED|95.0|0.1902|1.0665||Negative binomial (NB) regression model|Negative binomial (NB) regression model|adjusted for treatment and stratification of screening NT-proBNP||||1.0665|0.1902|0.0697
71834436|NCT00792636|143172808|SUPERIORITY_OR_OTHER||Least-squares mean|-1.9|||||TWO_SIDED|95.0|-3.4|-0.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.4|-3.4|
71834437|NCT00792636|143172808|SUPERIORITY_OR_OTHER||Least-squares mean|-0.7|||||TWO_SIDED|95.0|-2.0|0.6|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||0.6|-2.0|
71834438|NCT00792636|143172809|SUPERIORITY_OR_OTHER||Least-squares mean|-2.1|||||TWO_SIDED|95.0|-3.4|-0.8|||||Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.8|-3.4|
71834439|NCT00792636|143172809|SUPERIORITY_OR_OTHER||Least-squares mean|-1.5|||||TWO_SIDED|95.0|-2.6|-0.3|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||-0.3|-2.6|
71664938|NCT00863772|142843335|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.37||0.985|TWO_SIDED|95.0|-0.73|0.74|||ANCOVA|||ANCOVA model was used with treatment as main effect, baseline value as a covariate, and study site as a random effect.||0.74|-0.73|0.985
71664939|NCT01307748|142843400|OTHER|||||||0.005||||||The p value was adjusted for multiple comparisons using false discovery rate.|ANCOVA|Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.||The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.||||.005
71664940|NCT01307748|142843402|OTHER|||||||0.01||||||P value was adjusted for multiple comparisons using false discovery rate|ANCOVA|A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.||||||.01
71664941|NCT00315731|142843412|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-120)|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Ratio of AUC(0-120) is the ratio of AUC(0-120) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.12|0.85|
71664942|NCT00315731|142843413|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-168)|0.96|||||TWO_SIDED|90.0|0.83|1.11|||||Ratio of AUC(0-168) is the ratio of AUC(0-168) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.|||1.11|0.83|
71664943|NCT00315731|142843414|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0 to infinity)|0.93|||||TWO_SIDED|90.0|0.78|1.1||||||||1.10|0.78|
71744851|NCT00964496|143000829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.02|-2.13||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Comparisons were performed with the use of the independent-samples t test."||-2.13|-4.02|<0.001
71744852|NCT00964496|143000830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.95|||<|0.01|TWO_SIDED|95.0|6.0|9.9||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Comparisons were performed with the use of the independent-samples t test."||9.90|6.00|<0.01
71744853|NCT00964496|143000831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.0002474|TWO_SIDED|95.0|2.15|6.64||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Comparisons were performed with the use of the independent-samples t test."||6.64|2.15|0.00024740
71834440|NCT00792636|143172810|SUPERIORITY_OR_OTHER||Least-squares mean|0.4|||||TWO_SIDED|95.0|-1.6|2.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.4|-1.6|
71834441|NCT00792636|143172810|SUPERIORITY_OR_OTHER||Least-squares mean|0.5|||||TWO_SIDED|95.0|-1.2|2.2|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.2|
71834442|NCT00792636|143172811|SUPERIORITY_OR_OTHER||Least-squares mean|0.3|||||TWO_SIDED|95.0|-1.7|2.2|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.2|-1.7|
71664944|NCT00315731|142843415|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of Cmax|0.98|||||TWO_SIDED|90.0|0.87|1.11||||||||1.11|0.87|
71664945|NCT04614246|142843423|OTHER||LS-Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.13|-1.14|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.14|-2.13|
71834443|NCT00792636|143172811|SUPERIORITY_OR_OTHER||Least-squares mean|0.8|||||TWO_SIDED|95.0|-0.9|2.5|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure|||2.5|-0.9|
71834444|NCT00792636|143172816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
71834445|NCT00792636|143172816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.9|2.6||||||||2.6|0.9|
71834446|NCT00792636|143172817|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|0.6|
71834447|NCT00792636|143172817|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.2||||||||2.2|0.7|
71834448|NCT00792636|143172818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.1|13.6||||||||13.6|0.1|
71744854|NCT00964496|143000832|SUPERIORITY_OR_OTHER||Differences in proportions|-0.374||||0.00298881|TWO_SIDED|95.0|-0.563|-0.185||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||-0.185|-0.563|0.00298881
71664946|NCT04614246|142843423|OTHER||LS-Mean|-2.13|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.66|-1.61|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.61|-2.66|
71778013|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.29|0.92|
71778014|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.1|||||TWO_SIDED|95.0|0.93|1.31|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.31|0.93|
71778015|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.01|||||TWO_SIDED|95.0|0.85|1.2|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.2|0.85|
71778016|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 Strain)|1.12|||||TWO_SIDED|95.0|0.97|1.3|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.3|0.97|
71834449|NCT00792636|143172818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|0.3|25.6||||||||25.6|0.3|
71834450|NCT00792636|143172819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.7||||||||3.7|0.5|
71834451|NCT00792636|143172819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.6|4.2||||||||4.2|0.6|
71834452|NCT00792636|143172820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.84|1.54||||||||1.54|0.84|
71834453|NCT00792636|143172820|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.01|1.83||||||||1.83|1.01|
71834454|NCT00792636|143172821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.65|1.21||||||||1.21|0.65|
71834455|NCT00792636|143172821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.88|1.6||||||||1.60|0.88|
71834456|NCT02058108|143172832|OTHER|Missing assessment imputed using the closest available assessment|Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-37.03|36.75|||Fisher Exact|||HBV DNA level of \<300 copies/mL (51 IU/mL) at Week 24|Exact confidence interval for the difference in percentage|36.75|-37.03|1.0000
71664947|NCT04614246|142843423|OTHER||LS-Mean|-1.96|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|80.0|-2.48|-1.43|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.43|-2.48|
71664948|NCT04614246|142843423|OTHER||LS-Mean|-1.94|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|80.0|-2.44|-1.45|||Mixed Models Analysis|||80% confidence interval (CI) for change in mean worst EAPP from baseline to Week 12||-1.45|-2.44|
71664949|NCT04614246|142843424|OTHER|mixed model repeated measures|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.77|1.35||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.35|-0.77|
71664950|NCT04614246|142843424|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-1.27|0.91||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.91|-1.27|
71664951|NCT04614246|142843424|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|98.0|-1.17|1.02||||||Difference of least square-mean (95% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||1.02|-1.17|
71744855|NCT00964496|143000833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1557.14|||<|0.01|TWO_SIDED|95.0|1294.53|1819.76||P\<0.05 was considered as statistical different, while P\>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Comparisons were performed with the use of the independent-samples t test."||1819.76|1294.53|<0.01
71744856|NCT00964496|143000834|SUPERIORITY_OR_OTHER||Differences in proportions|0.464||||3.962e-05|TWO_SIDED|95.0|0.28|0.649|||Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the cessation of bleeding.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the cessation of bleeding.~Comparisons were performed with the use of the chi-square test, Fisher's exact test."||0.649|0.28|0.00003962
71744857|NCT01147666|143000881|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
71834457|NCT02058108|143172834|OTHER||Mean Difference (Net)|32.43||||0.2984|TWO_SIDED|95.0|-14.62|74.6|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|ALT levels at Week 24||74.60|-14.62|0.2984
71744858|NCT01147666|143000881|OTHER|||||||0.0698||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.0698
71744859|NCT01147666|143000881|OTHER|||||||0.1534||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.1534
71834458|NCT02058108|143172835|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg loss at Week 24||60.20|-53.70|1.0000
71664952|NCT04614246|142843424|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|0.29|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|80.0|-0.4|0.98||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.98|-0.4|
71664953|NCT04614246|142843424|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|80.0|-0.89|0.53||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.53|-0.89|
71664954|NCT04614246|142843424|OTHER|mixed model repeated measures (MMRM)|Difference of least square-mean|-0.08|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|80.0|-0.79|0.64||||||Difference of least square-mean (80% Confidence Interval, CI) - Eliapixant arms vs Placebo arm (pairwise comparison) - change in mean worst EAPP from baseline to Week 12 - pPPS||0.64|-0.79|
71744860|NCT01147666|143000881|OTHER|||||||0.2657||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||0.2657
71744861|NCT01147666|143000882|OTHER|||||||1||||||Threshold for significance at 0.05 level.|Fisher Exact|||||||1.0000
71744862|NCT01135134|143000908|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71744863|NCT01135134|143000909|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71744864|NCT01217463|143000937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.4109|TWO_SIDED|95.0|0.6|3.43|||Regression, Logistic|||||3.43|0.60|0.4109
71744865|NCT01217463|143000938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|0.78|2.4|||Regression, Logistic|||||2.4|0.78|
71744866|NCT03246789|143000995|SUPERIORITY||Mean Difference (Final Values)|2.15||||0.31|TWO_SIDED|95.0|-2.09|6.39|||t-test, 2 sided|||Week 12||6.39|-2.09|0.31
71744867|NCT03246789|143000996|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.28|TWO_SIDED|95.0|-4.22|1.28|||t-test, 2 sided|||Domain #1, Week 12||1.28|-4.22|0.28
71744868|NCT03246789|143000996|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.5|TWO_SIDED|95.0|-3.48|1.74|||t-test, 2 sided|||Domain #2, Week 12||1.74|-3.48|0.50
71744869|NCT03246789|143000996|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.02|TWO_SIDED|95.0|-2.88|-0.28|||t-test, 2 sided|||Domain #3, Week 12||-0.28|-2.88|0.02
71744870|NCT03246789|143000996|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.98|TWO_SIDED|95.0|-3.63|3.53|||t-test, 2 sided|||Domain 4, Week 12||3.53|-3.63|0.98
71744871|NCT03246789|143000997|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.92|TWO_SIDED|95.0|-0.64|0.58|||t-test, 2 sided|||Domain #1, Week 12||0.58|-0.64|0.92
71744872|NCT03246789|143000997|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.48|TWO_SIDED|95.0|-0.69|0.33|||t-test, 2 sided|||Domain #2, Week 12||0.33|-0.69|0.48
71744873|NCT03246789|143000997|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.48|TWO_SIDED|95.0|-0.33|0.69|||t-test, 2 sided|||||0.69|-0.33|0.48
71744874|NCT02756572|143001011|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71744875|NCT02756572|143001012|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71744876|NCT02756572|143001013|OTHER|||||||0.049|||||||Fisher Exact|||||||0.049
71744877|NCT02756572|143001014|OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71744878|NCT03628976|143001017|SUPERIORITY|||||||0.0096|||||||ANOVA|||||||0.0096
71744879|NCT03628976|143001018|SUPERIORITY|||||||0.764|||||||ANOVA|||||||0.764
71744880|NCT03628976|143001019|SUPERIORITY|||||||0.446|||||||ANOVA|||||||0.446
71664955|NCT02883049|142843442|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.893|TWO_SIDED|95.0|0.74|1.413|||Log Rank||Hazard ratio = hazard rate for Arm B/hazard rate for Arm A|To compare the DFS of the randomized patients on HR B-ALL Arm A vs Arm B. With a total of 1800 patients accrued over 5 years with minimum follow up of 2 years, randomized 1:1 to the 2 arms, we will be able to detect an improvement in 5-year DFS from 90% to 94 (HR=0.5873) between IT MTX and ITT based regimens (2-sided log rank test, alpha=5%), with 84.2% power.||1.413|0.74|0.893
71744881|NCT01507688|143001065|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|||||P-value was not adjusted for multiple comparisons. Models adjusted for: VA vs Non Va, admission diagnosis (transient ischemic attack vs stroke), sex (male vs female), white vs nonwhite, and baseline total Stroke Specific Quality of life score.|Mixed Models Analysis|Repeated measurements of change GEE analyses of Total Stroke Specific Quality of Life score change at 6 months from baseline.|The adjusted positive mean (standard error) change at 6 months from baseline was higher in the intervention arm compared to in the control arm. Intervention group had 0.14 (SE 0.17) higher improvement compared to the control group.|"All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis."||||0.0500
71744882|NCT01507688|143001065|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|||||Adjusted least square means (standard errors) adjusted for treatment (Intervention vs control), time of outcome from baseline (3, 6, 12 months), baseline SSQoL, Site (VA vs NonVA), Stroke/TIA diagnosis, sex (m vs f) and race (white vs nonwhite).|Mixed Models Analysis||Adjusted intervention arm's positive change (regression coefficient with standard error) in Total Stroke Specific Quality of Life was not significantly different at 12 months compared to the control group.|"We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis."||||0.26
71744883|NCT02163824|143001066|SUPERIORITY||Difference in % of responders|16.1||||0.0024|TWO_SIDED|95.0|5.9|26.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||26.4|5.9|.0024
71744884|NCT02163824|143001066|SUPERIORITY||Difference in % of responders|22.1|||<|0.0001|TWO_SIDED|95.0|11.7|32.6|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||32.6|11.7|<.0001
71744885|NCT02163824|143001067|SUPERIORITY||Difference in % of responders|19.5||||0.0019|TWO_SIDED|95.0|7.4|31.5|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||31.5|7.4|.0019
71744886|NCT02163824|143001067|SUPERIORITY||Difference in % of responders|22.5||||0.0003|TWO_SIDED|95.0|10.6|34.4|||Chi-squared||Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|"All statistical tests of hypotheses performed for the pairwise comparison of means were two-sided.~All statistical tests employed a level of significance of alpha = 0.05."||34.4|10.6|.0003
71744887|NCT02163824|143001068|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0007|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 8.|||||0.0007
71744888|NCT02163824|143001068|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean grade AC at Day 8.|||||0.0440
71744889|NCT02163824|143001069|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0391|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.0391
71744890|NCT02163824|143001069|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1811|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean AC grade at Day 15.|||||0.1811
71744891|NCT02163824|143001070|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.1953|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain grade at Day 8.|||||0.1953
71744892|NCT02163824|143001070|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.0307|TWO_SIDED||||||ANCOVA||Estimated value is the between group difference of mean ocular pain grade at Day 8.|||||0.0307
71744893|NCT02163824|143001071|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2589|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference on mean ocular pain score at Day 15.|||||0.2589
71744894|NCT02163824|143001071|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.2132|TWO_SIDED||||||ANCOVA||Estimated value is the between-group difference in mean ocular pain score at Day 15.|||||0.2132
71744895|NCT01272232|143001118|SUPERIORITY_OR_OTHER||Treatment contrast|-3.97|||<|0.0001||95.0|-4.84|-3.11||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-3.11|-4.84|<0.0001
71744896|NCT01272232|143001118|SUPERIORITY_OR_OTHER||Treatment contrast|-2.62|||<|0.0001||95.0|-3.63|-1.62||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.62|-3.63|<0.0001
71834459|NCT02058108|143172835|OTHER||Mean Difference (Net)|2.7||||1|TWO_SIDED|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg seroconversion at Week 24||60.20|-53.70|1.0000
71664956|NCT02883049|142843443|SUPERIORITY||Hazard Ratio (HR)|1.019||||0.556|ONE_SIDED|97.5||1.335|||Log Rank||Hazard ratio = hazard rate for Experimental Arm 1 /hazard rate for Control Arm|To compare the DFS of the randomized patients on Control Arm vs. Experimental Arm 1. This study design will have 86.8% power (1-sided log rank test, adjusted alpha=0.025 for multiple comparisons) to detect an improvement in 4-year DFS from 70% to 79% (HR=0.661) between the control arm and the experimental arm.||1.335||0.556
71664957|NCT00826007|142843474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|0.09|0.18|||Regression, Logistic|||||.18|.09|<0.001
71664958|NCT00369486|142843479|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||Adjusted for baseline central subfield thickness|repeated measures least sq. regression|Models adjusted for baseline values and for correlated data from subjects with two study eyes.||Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.||||0.46
71664959|NCT00369486|142843480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.04||95.0|0.2|1.0|||generalized estimating equations|||Analysis combined posterior and anterior injection + laser groups to compare with laser only.||1.0|0.2|0.04
71664960|NCT00369486|142843480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.63||95.0|0.5|2.9|||generalized estimating equations|||Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.||2.9|0.5|0.63
71664961|NCT00369486|142843481|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||repeated measures least sq. regression|Adjusted for baseline values and for the correlated data from subjects with two study eyes.||Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.||||0.94
71664962|NCT01392963|142843485|OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71744897|NCT01272232|143001118|SUPERIORITY_OR_OTHER||Treatment contrast|-1.35||||0.0024||95.0|-2.23|-0.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.48|-2.23|0.0024
71664963|NCT02856802|142843530|NON_INFERIORITY|Assumption that 15% of placebo and 42% of DFN 02 10 mg (treated) subjects would be pain-free at 2 hours. A sample size of 50 subjects in each DB1 dosing arm provided 86% power to detect this assumed difference between placebo and DFN-02 10 mg at a 5% (2-sided) level of significance.|Odds Ratio (OR)|2.68||||0.044|TWO_SIDED|95.0|1.05|6.83|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the statistical analysis system (SAS)® software package (version 9.3).||6.83|1.05|0.044
71664964|NCT02856802|142843531|NON_INFERIORITY|Non-inferiority conducted as specified in the statistical analysis plan (SAP).||||||0.007||||||The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups.|Fisher Exact|||||||0.007
71744898|NCT01272232|143001119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.81|||<|0.0001||95.0|4.34|10.68||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||10.68|4.34|<0.0001
71744899|NCT01272232|143001119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.69|||<|0.0001||95.0|2.24|6.09||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||6.09|2.24|<0.0001
71744900|NCT01272232|143001119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0008||95.0|1.29|2.64||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.64|1.29|0.0008
71834460|NCT02058108|143172836|OTHER||Mean Difference (Net)|2.44||||1|TWO_SIDED|95.0|-37.54|42.17|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBsAg loss at Week 24||42.17|-37.54|1.0000
71664965|NCT02856802|142843532|NON_INFERIORITY|No assumptions made.|Odds Ratio (OR)|1.31||||0.642|TWO_SIDED|95.0|0.52|3.3|||Fisher Exact|||Statistical testing and confidence intervals (CIs) were 2 sided and performed using a significance (alpha) level of 0.05. All statistical analyses were conducted with the SAS® software package (version 9.3).||3.30|0.52|0.642
71664966|NCT01403051|142843552|SUPERIORITY_OR_OTHER|||||||0.001||||||2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.|Stratified Wilcoxon rank sum test|Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (\<=20 vs. \>20 ng/mL)||The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.||||0.001
71744901|NCT01272232|143001120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.0001||95.0|3.48|14.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||14.48|3.48|<0.0001
71834461|NCT02058108|143172839|OTHER||Mean Difference (Net)|2.5||||1|TWO_SIDED|95.0|-37.05|41.83|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|Treatment emergent genotypic resistance at Week 24||41.83|-37.05|1.0000
71664967|NCT03743415|142843589|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.16||0.81|TWO_SIDED|95.0|-2.5|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of the symptom index, adjusting for baseline value.|Mean of SMSH alone minus mean of SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||1.96|-2.50|.81
71664968|NCT03743415|142843589|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|2.07||0.78|TWO_SIDED|95.0|-4.65|3.49||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|The model included adjustment for baseline value of the symptom index.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||3.49|-4.65|.78
71664969|NCT03743415|142843589|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over time (weeks 1-13).|Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.76||0.27|TWO_SIDED|95.0|-0.66|2.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||2.32|-0.66|.27
71664970|NCT03743415|142843589|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|1.35||0.19|TWO_SIDED|95.0|-0.88|4.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size d=0.54 between the SMSH alone group and SMSH+TIPC group was detectable with power of .94 in two-sided tests at .05 level of significance.||4.39|-0.88|.19
71664971|NCT03743415|142843590|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|2.46||0.53|TWO_SIDED|95.0|-3.3|6.36||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||6.36|-3.30|.53
71664972|NCT03743415|142843590|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|3.92||0.97|TWO_SIDED|95.0|-5.7|9.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||9.68|-5.70|.97
71664973|NCT03743415|142843590|SUPERIORITY|The key parameter was the coefficient for the trial arm difference in linear mixed effects model that included reflected average difference between arms over weeks 5-13.|Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.94||0.31|TWO_SIDED|95.0|-1.83|5.75||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH alone minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. . The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||5.75|-1.83|.31
71778017|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.85|1.13|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.13|0.85|
71834462|NCT04059042|143172841|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|39.0||||0.0051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0051
71664974|NCT03743415|142843590|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED|95.0|-2.13|8.74||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The adjusted effect size (Cohen's d=0.54) was used to power comparisons on the primary outcomes reported by groups from the second randomization. This analysis indicated that 60 per group would be required for power of .80 or greater in two-sided tests at α= 0.05.||8.74|-2.13|.61
71664975|NCT03743415|142843591|SUPERIORITY|Key parameter was the difference between arms at week 13.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.14||0.44|TWO_SIDED|95.0|-3.12|1.35||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.35|-3.12|.44
71664976|NCT03743415|142843591|SUPERIORITY|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|1.15||0.95|TWO_SIDED|95.0|-2.32|2.18||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.||2.18|-2.32|.95
71664977|NCT03743415|142843591|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.96||0.97|TWO_SIDED|95.0|-1.85|1.93||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.93|-1.85|.97
71778018|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.87|||||TWO_SIDED|95.0|0.76|1.01|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.01|0.76|
71778019|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.06|||||TWO_SIDED|95.0|0.91|1.23|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.23|0.91|
71834463|NCT04059042|143172841|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|19.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.03
71834464|NCT04059042|143172842|EQUIVALENCE|Between-session pain measures were assessed with related-samples Wilcoxon signed-rank tests (Audio minus Silence). Data were not normally distributed so nonparametric tests were used.|Z score|18.0||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
71778020|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.15|||||TWO_SIDED|95.0|0.99|1.33|||ANOVA||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.33|0.99|
71834465|NCT04059042|143172842|EQUIVALENCE|Between-session change scores were calculated per participant as Audio minus Silence and compared between groups with independent samples Mann-Whitney U-tests. Data were not normally distributed so nonparametric tests were used.|Z score|14.0||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71834466|NCT00522951|143172991|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.58||||||95.0|-0.87|-0.29|||||Averaged blinded reader (primary analysis)|H01: μG1 - μPr ≤ -1||-0.29|-0.87|
71664978|NCT03743415|142843591|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.96||0.74|TWO_SIDED|95.0|-1.56|2.2||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.20|-1.56|.74
71664979|NCT03743415|142843592|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|2.31||0.98|TWO_SIDED|95.0|-4.49|4.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus mean of SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.58|-4.49|.98
71664980|NCT03743415|142843592|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|2.34||0.7|TWO_SIDED|95.0|-5.48|3.68||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.68|-5.48|.70
71664981|NCT03743415|142843592|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.85||0.27|TWO_SIDED|95.0|-5.62|1.62||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.62|-5.62|.27
71664982|NCT03743415|142843592|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.84||0.91|TWO_SIDED|95.0|-3.4|3.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.81|-3.40|.91
71664983|NCT03743415|142843593|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|1.06||0.06|TWO_SIDED|95.0|-3.98|0.19||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.19|-3.98|.06
71664984|NCT03743415|142843593|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.0||0.09|TWO_SIDED|95.0|-3.81|0.11||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||0.11|-3.81|.09
71778021|NCT00617851|143055296|NON_INFERIORITY_OR_EQUIVALENCE|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, \>= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.09|||||TWO_SIDED|95.0|0.94|1.26|||ANOVA||"The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).||1.26|0.94|
71778022|NCT01788046|143055313|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|30.8|||<|0.001|TWO_SIDED|95.0|18.18|52.17|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of percentage of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||52.17|18.18|< 0.001
71834467|NCT00522951|143172991|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.06||||||95.0|-0.23|0.36|||||Averaged blinded reader (primary analysis)|H02: μG2 - μPr ≤ -1||0.36|-0.23|
71664985|NCT03743415|142843593|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.97||0.89|TWO_SIDED|95.0|-1.77|2.04||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.04|-1.77|.89
71664986|NCT03743415|142843593|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.96||0.47|TWO_SIDED|95.0|-1.2|2.58||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.58|-1.20|.47
71664987|NCT03743415|142843594|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|1.94||0.45|TWO_SIDED|95.0|-5.22|2.39||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||2.39|-5.22|.45
71834468|NCT00522951|143172991|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|-0.3||||||95.0|-0.5|-0.1|||||Investigator (secondary analysis)|H01: μG1 - μPr ≤ -1||-0.1|-0.5|
71834469|NCT00522951|143172991|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin = -1|Mean Difference (Final Values)|0.21||||||95.0|0.02|0.41|||||Investigator (secondary analysis)|H02: μG2 - μPr ≤ -1||0.41|0.02|
71834470|NCT03398148|143173130|SUPERIORITY||Adjusted Risk Difference|9.6||||0.0324|TWO_SIDED|90.0|2.2|17.0||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||17.0|2.2|0.0324
71834471|NCT03398148|143173130|SUPERIORITY||Adjusted Risk Difference|8.4||||0.046|TWO_SIDED|90.0|1.5|15.3||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo)|||15.3|1.5|0.0460
71834472|NCT03398148|143173130|SUPERIORITY||Adjusted Risk Difference|8.7||||0.0397|TWO_SIDED|90.0|1.7|15.6||P-value ≤ 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (≤ 7, \> 7).|Risk difference = (risankizumab - Placebo).|||15.6|1.7|0.0397
71834473|NCT03398148|143173131|SUPERIORITY||Adjusted Risk Difference|14.0|||<|0.0001|TWO_SIDED|95.0|10.0|18.0||Type I error rate control.|Cochran-Mantel-Haenszel|Stratified by Advanced Therapy-IR status (yes vs no), Baseline steroid use (yes vs. no) and Baseline Adapted Mayo Score (≤ 7, \> 7).||||18.0|10.0|<0.0001
71834474|NCT03398148|143173132|SUPERIORITY||Adjusted Risk Difference|18.7||||0.0028|TWO_SIDED|90.0|8.4|29.0||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||29.0|8.4|0.0028
71834475|NCT03398148|143173132|SUPERIORITY||Adjusted Risk Difference|8.4||||0.0968|TWO_SIDED|90.0|0.1|16.7||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||16.7|0.1|0.0968
71834476|NCT03398148|143173132|SUPERIORITY||Adjusted Risk Difference|10.5||||0.0512|TWO_SIDED|90.0|1.6|19.3||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||19.3|1.6|0.0512
71778023|NCT01788046|143055314|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|33.92|||<|0.001|TWO_SIDED|95.0|16.35|70.37|||Cochran-Mantel-Haenszel|Stratified by screening PTH category, prior cinacalcet use within 8 weeks prior to randomization, and region.||||70.37|16.35|< 0.001
71778024|NCT01788046|143055315|SUPERIORITY_OR_OTHER||Mean Difference|-71.34|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-77.53|-65.14|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-65.14|-77.53|< 0.001
71834477|NCT03398148|143173134|SUPERIORITY||Adjusted Risk Difference|23.9||||0.0022|TWO_SIDED|90.0|11.0|36.7||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.7|11.0|0.0022
71834478|NCT03398148|143173134|SUPERIORITY||Adjusted Risk Difference|28.4||||0.0002|TWO_SIDED|90.0|15.7|41.1||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||41.1|15.7|0.0002
71834479|NCT03398148|143173134|SUPERIORITY||Adjusted Risk Difference|33.8|||<|0.0001|TWO_SIDED|90.0|20.7|46.9||P-value ≤ 0.001|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||46.9|20.7|<0.0001
71834480|NCT03398148|143173135|SUPERIORITY||Adjusted Risk Difference|10.2||||0.1842|TWO_SIDED|90.0|-2.4|22.9|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||22.9|-2.4|0.1842
71834481|NCT03398148|143173135|SUPERIORITY||Adjusted Risk Difference|23.2||||0.0041|TWO_SIDED|90.0|9.9|36.4||P-value ≤ 0.01|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||36.4|9.9|0.0041
71834482|NCT03398148|143173135|SUPERIORITY||Adjusted Risk Difference|13.1||||0.1117|TWO_SIDED|90.0|-0.4|26.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||26.6|-0.4|0.1117
71664988|NCT03743415|142843594|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.97||0.82|TWO_SIDED|95.0|-3.59|4.12||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.12|-3.59|.82
71664989|NCT03743415|142843594|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 13 in linear mixed effects model.|Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.13|4.23||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||4.23|-3.13|.77
71664990|NCT03743415|142843594|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at week 17 in linear mixed effects model.|Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|1.87||0.86|TWO_SIDED|95.0|-3.98|3.34||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome was adjusted for in the model.|Mean of SMSH minus SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||3.34|-3.98|.86
71664991|NCT01701011|142843595|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
71664992|NCT01701011|142843595|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.||||<0.05
71664993|NCT01701011|142843596|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.||||<0.05
71834483|NCT03398148|143173136|SUPERIORITY||Adjusted Risk Difference|8.3||||0.0192|TWO_SIDED|90.0|2.5|14.1||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.1|2.5|0.0192
71778025|NCT01788046|143055316|SUPERIORITY_OR_OTHER||Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-8.38|-6.03|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-6.03|-8.38|< 0.001
71778026|NCT01788046|143055317|SUPERIORITY_OR_OTHER||Mean Difference|-14.58|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-18.65|-10.51|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.51|-18.65|< 0.001
71778027|NCT01788046|143055318|SUPERIORITY_OR_OTHER||Mean Difference|-8.04|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-12.15|-3.92|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-3.92|-12.15|< 0.001
71778028|NCT04269707|143055324|NON_INFERIORITY|Change in hemoglobin from baseline to day 35 was assessed using paired t-tests (two-sided test, alpha = 0.05).|Mean Difference (Final Values)|0.7||||0.1711|TWO_SIDED|95.0|-0.4|1.8|||t-test, 2 sided|||||1.80|-0.40|0.1711
71834484|NCT03398148|143173136|SUPERIORITY||Adjusted Risk Difference|4.8||||0.0706|TWO_SIDED|90.0|0.4|9.1||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.1|0.4|0.0706
71778029|NCT05047770|143055347|NON_INFERIORITY|The non-inferiority was to be concluded if the upper limit (UL) of the 95% confidence interval (CI) of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-gE antibody concentration was below (\<) 1.5.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 2 doses of HZ/su vaccine when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to HZ/su vaccine administered alone, in terms of anti-gE GMCs, at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group).||1.13|0.89|
71834485|NCT03398148|143173136|SUPERIORITY||Adjusted Risk Difference|8.7||||0.017|TWO_SIDED|90.0|2.7|14.6||P-value ≤ 0.05|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||14.6|2.7|0.0170
71664994|NCT00976911|142843632|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|15.7|||||TWO_SIDED|95.0|6.5|24.8||||||||24.8|6.5|
71664995|NCT00976911|142843632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Pearson's chi-square|unstratified analysis||||||0.0010
71664996|NCT00976911|142843632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Cochran-Mantel-Haenszel|||||||0.0007
71834486|NCT03398148|143173137|SUPERIORITY|||||||0.7737|||||||Chi-squared|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7737
71664997|NCT00976911|142843633|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45||||0.0202|TWO_SIDED|95.0|0.225|0.9||Unstratified analysis|Log Rank||Hazard ratio was estimated by unstratified Cox regression model.|||0.900|0.225|0.0202
71664998|NCT00976911|142843633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0081|TWO_SIDED||||||Peto-Peto-Prentice|||||||0.0081
71664999|NCT00976911|142843635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.379|||<|0.0001|TWO_SIDED|95.0|0.296|0.485|||Log Rank||Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (less than \[\<\] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.|||0.485|0.296|<0.0001
71665000|NCT00976911|142843635|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.366|0.577|||Log Rank|Unstratified analysis||||0.577|0.366|<0.0001
71665001|NCT00976911|142843635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Unstratified analysis||||||<0.0001
71665002|NCT00976911|142843635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Peto-Peto-Prentice|Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.||||||<0.0001
71665003|NCT00976911|142843636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.833||||0.136|TWO_SIDED|95.0|0.655|1.059||Unstratified analysis|Log Rank|||||1.059|0.655|0.1360
71778030|NCT05047770|143055348|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between HZ/suSeq group and HZ/suCoAd group for anti-S protein antibody concentration was \<1.5.|GMC Ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when the first dose of HZ/su vaccine was co-administered with the mRNA-1273 booster dose compared to mRNA-1273 booster dose administered alone, in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both HZ/suSeq and HZ/suCoAd groups).||1.32|0.90|
71778031|NCT05047770|143055349|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H1N1 influenza strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.89|1.18|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.18|0.89|
71778032|NCT05047770|143055349|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the A/H3N2 influenza strain.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.05|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.05|0.82|
71834487|NCT03398148|143173137|SUPERIORITY|||||||0.7432|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7432
71834488|NCT03398148|143173137|SUPERIORITY|||||||0.7172|||||||Fisher Exact|P value for comparisons between treatment groups and placebo group using chi-square test or Fisher's exact test.||||||0.7172
71665004|NCT00976911|142843636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0715|TWO_SIDED|||||Unstratified analysis|Peto-Peto-Prentice|||||||0.0715
71665005|NCT00976911|142843636|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2711|TWO_SIDED|95.0|0.678|1.116||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Log Rank|||||1.116|0.678|0.2711
71665006|NCT00976911|142843636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|TWO_SIDED|||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (\<3 or 3-6 months).|Peto-Peto-Prentice|||||||0.0890
71665007|NCT00976911|142843637|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|8.8||||0.1859|TWO_SIDED|95.0|-3.8|21.4|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus Week 8/9||21.4|-3.8|0.1859
71665008|NCT00976911|142843637|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|3.5||||0.8309|TWO_SIDED|95.0|-14.0|20.9|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 16/18||20.9|-14|0.8309
71665009|NCT00976911|142843637|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|9.3||||0.579|TWO_SIDED|95.0|-15.0|34.1|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 24||34.1|-15|0.5790
71665010|NCT00976911|142843637|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|-4.8||||0.7339|TWO_SIDED|95.0|-40.0|30.6|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 30||30.6|-40|0.7339
71665011|NCT00005957|142843655|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.38|TWO_SIDED|95.0|0.72|1.13|||Log Rank||Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.|It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.||1.13|0.72|0.38
71665012|NCT00005957|142843656|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.01|TWO_SIDED|95.0|0.61|0.94|||Log Rank|||||0.94|0.61|0.01
71665013|NCT01651793|142843777|SUPERIORITY|||||||0.05||||||P value reference to the beverage x time interaction effect|ANCOVA|||Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night's sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.||||0.05
71834489|NCT03398148|143173138|SUPERIORITY||Adjusted Risk Difference|4.7||||0.0722|TWO_SIDED|90.0|0.4|9.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||9.0|0.4|0.0722
71834490|NCT03398148|143173138|SUPERIORITY||Adjusted Risk Difference|3.1||||0.148|TWO_SIDED|90.0|-0.4|6.6|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||6.6|-0.4|0.1480
71834491|NCT03398148|143173138|SUPERIORITY||Adjusted Risk Difference|1.7||||0.3042|TWO_SIDED|90.0|-1.0|4.5|||Cochran-Mantel-Haenszel|Stratified by baseline corticosteroid use (yes, no) and baseline adapted mayo score (\<= 7, \> 7).|Risk difference = (risankizumab - Placebo).|||4.5|-1.0|0.3042
71834492|NCT03398148|143173139|SUPERIORITY||Least Squares (LS) Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|2.13||0.003|TWO_SIDED|90.0|-9.94|-2.89||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||-2.89|-9.94|0.0030
71834493|NCT03398148|143173139|SUPERIORITY||Least Squares (LS) Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|2.11||0.0001|TWO_SIDED|90.0|-11.67|-4.71||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.71|-11.67|0.0001
71834494|NCT03398148|143173139|SUPERIORITY||Least Squares (LS) Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.14||0.0004|TWO_SIDED|90.0|-11.27|-4.19||P-value ≤ 0.001|Mixed-effect model repeated measurement|||||-4.19|-11.27|0.0004
71834495|NCT03398148|143173140|SUPERIORITY||Least Squares (LS) Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|6.47||0.0081|TWO_SIDED|90.0|6.61|28.0||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||28|6.61|0.0081
71834496|NCT03398148|143173140|SUPERIORITY||Least Squares (LS) Mean Difference|20.3|STANDARD_ERROR_OF_MEAN|6.37||0.0017|TWO_SIDED|90.0|9.74|30.79||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.79|9.74|0.0017
71834497|NCT03398148|143173140|SUPERIORITY||Least Squares (LS) Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|6.49||0.0024|TWO_SIDED|90.0|9.22|30.67||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||30.67|9.22|0.0024
71834498|NCT03398148|143173141|SUPERIORITY||Least Squares (LS) Mean Difference|1.208||||0.3315|TWO_SIDED|90.0|-0.8429|3.2596|||Mixed-effect model repeated measurement|||||3.2596|-0.8429|0.3315
71665014|NCT03713632|142843786|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0149|TWO_SIDED|95.0|1.05|2.55||one-sided p-value|Regression, Logistic|||||2.55|1.05|0.0149
71834499|NCT03398148|143173141|SUPERIORITY||LS Mean of Difference|2.447||||0.0451|TWO_SIDED|90.0|0.4415|4.4519||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||4.4519|0.4415|0.0451
71665015|NCT03713632|142843786|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0022|TWO_SIDED|95.0|1.22|2.96||one-sided p-value|Regression, Logistic|||||2.96|1.22|0.0022
71834500|NCT03398148|143173141|SUPERIORITY||LS Mean of Difference|2.392||||0.0543|TWO_SIDED|90.0|0.3498|4.4352||P-value ≤ 0.1|Mixed-effect model repeated measurement|||||4.4352|0.3498|0.0543
71834501|NCT03398148|143173142|SUPERIORITY||LS Mean of Difference|3.662||||0.0367|TWO_SIDED|90.0|0.7841|6.5402||P-value \<= 0.1|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||6.5402|0.7841|0.0367
71834502|NCT03398148|143173142|SUPERIORITY||LS Mean of Difference|4.19||||0.0151|TWO_SIDED|90.0|1.3656|7.0144||P-value \<= 0.05|Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||7.0144|1.3656|0.0151
71834503|NCT03398148|143173142|SUPERIORITY||LS Mean of Difference|2.348||||0.1795|TWO_SIDED|90.0|-0.5322|5.2281|||Mixed-effect model repeated measurement||P-value for test of difference between each Risankizumab dose group and placebo for mean change from baseline using the mixed-effect repeated measure model The unstructured covariance structure was used to estimate within subject errors.|||5.2281|-0.5322|0.1795
71834504|NCT03398148|143173143|SUPERIORITY||Least Squares (LS) Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.91||0.0422|TWO_SIDED|90.0|0.75|7.06||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.06|0.75|0.0422
71834505|NCT03398148|143173143|SUPERIORITY||Least Squares (LS) Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|1.87||0.0049|TWO_SIDED|90.0|2.23|8.42||P-value ≤ 0.01|Mixed-effect model repeated measurement|||||8.42|2.23|0.0049
71834506|NCT03398148|143173143|SUPERIORITY||Least Squares (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.91||0.0156|TWO_SIDED|90.0|1.5|7.8||P-value ≤ 0.05|Mixed-effect model repeated measurement|||||7.80|1.50|0.0156
71665016|NCT03713632|142843787|SUPERIORITY||Mean Difference (Net)|-16.33||||0.0051|TWO_SIDED|95.0|-28.79|-3.88||one-side p-value|ANCOVA|||||-3.88|-28.79|0.0051
71665017|NCT03713632|142843787|SUPERIORITY||Mean Difference (Net)|-22.94||||0.0001|TWO_SIDED|95.0|-35.24|-10.63||one-side p-value|ANCOVA|||||-10.63|-35.24|0.0001
71665018|NCT03713632|142843788|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0732|TWO_SIDED|95.0|0.41|1.14||one-sided p-value|Regression, Logistic|||||1.14|0.41|0.0732
71665019|NCT03713632|142843788|SUPERIORITY||Odds Ratio (OR)|0.49||||0.0049|TWO_SIDED|95.0|0.29|0.84||one-sided p-value|Regression, Logistic|||||0.84|0.29|0.0049
71665020|NCT03713632|142843789|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0026|TWO_SIDED|95.0|1.28|4.09||one-sided p-value|Regression, Logistic|||||4.09|1.28|0.0026
71665021|NCT03713632|142843789|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0206|TWO_SIDED|95.0|1.03|3.37||one-sided p-value|Regression, Logistic|||||3.37|1.03|0.0206
71834507|NCT03398148|143173144|SUPERIORITY|||||||1||||||P-Value for comparisons between treatment groups and placebo group using Fisher's exact test.|Fisher Exact|||Note: ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Sub-Study 1.||||1
71834508|NCT03398148|143173145|SUPERIORITY||Adjusted Risk Difference|28.6|||<|0.0001|TWO_SIDED|95.0|22.3|34.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||34.8|22.3|<0.0001
71834509|NCT03398148|143173146|SUPERIORITY||Adjusted Risk Difference|24.3|||<|0.0001|TWO_SIDED|95.0|19.3|29.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||29.4|19.3|<0.0001
71834510|NCT03398148|143173147|SUPERIORITY||Adjusted Risk Difference|16.6|||<|0.0001|TWO_SIDED|95.0|12.3|21.0||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||21.0|12.3|<0.0001
71834511|NCT03398148|143173148|SUPERIORITY||Adjusted Risk Difference|7.2|||<|0.0001|TWO_SIDED|95.0|4.2|10.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||10.2|4.2|<0.0001
71834512|NCT03398148|143173149|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.6|28.1||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||28.1|15.6|<0.0001
71834513|NCT03398148|143173150|SUPERIORITY||Adjusted Risk Difference|16.3|||<|0.0001|TWO_SIDED|95.0|10.3|22.4||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||22.4|10.3|<0.0001
71834514|NCT03398148|143173151|SUPERIORITY||Adjusted Risk Difference|9.3||||0.0021|TWO_SIDED|95.0|3.4|15.3||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||15.3|3.4|0.0021
71834515|NCT03398148|143173152|SUPERIORITY||Adjusted Risk Difference|5.6|||<|0.0001|TWO_SIDED|95.0|3.5|7.7||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||7.7|3.5|<0.0001
71834516|NCT03398148|143173153|SUPERIORITY||Least Squares (LS) Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.13|5.97||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||5.97|3.13|<0.0001
71834517|NCT03398148|143173154|SUPERIORITY||Least Squares (LS) Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|13.38|23.25||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|ANCOVA||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||23.25|13.38|<0.0001
71834518|NCT03398148|143173155|SUPERIORITY||Risk Difference (RD)|-4.8|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.2||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Chi-squared||95% CI for treatment differences is based on normal approximation of the binomial proportions.|||-2.2|-7.3|<0.0001
71665022|NCT02892149|142843792|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.23|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.23|
71665023|NCT02892149|142843793|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.96||||0.4745|TWO_SIDED|95.0|0.828|1.117|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.117|0.828|0.4745
71665024|NCT02892149|142843793|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
71665025|NCT02892149|142843794|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.25|-0.12||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.12|-0.25|
71665026|NCT02892149|142843795|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.3718|TWO_SIDED|95.0|0.832|1.097|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.097|0.832|0.3718
71665027|NCT02892149|142843795|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
71665028|NCT02892149|142843796|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.94||||0.3875|TWO_SIDED|95.0|0.777|1.131|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.131|0.777|0.3875
71665029|NCT02892149|142843796|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
71834519|NCT03398148|143173156|SUPERIORITY||Adjusted Risk Difference|24.2|||<|0.0001|TWO_SIDED|95.0|17.9|30.5||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference. (Greenland and Robins (1985)).|||30.5|17.9|<0.0001
71834520|NCT03398148|143173157|SUPERIORITY||Adjusted Risk Difference|18.6|||<|0.0001|TWO_SIDED|95.0|12.4|24.8||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Cochran-Mantel-Haenszel||Between-group diff. and 95% CI calculated using Mantel-Haenszel common rate difference.|||24.8|12.4|<0.0001
71834521|NCT03398148|143173158|SUPERIORITY||Least Squares (LS) Mean Difference|-1.627|||<|0.0001|TWO_SIDED|95.0|-2.3846|-0.8689||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.8689|-2.3846|<0.0001
71834522|NCT03398148|143173159|SUPERIORITY||Least Squares (LS) Mean Difference|-0.981|||<|0.0001|TWO_SIDED|95.0|-1.3285|-0.6326||Statistical significance is determined via the graphical multiple testing procedure controlling the overall type I error rate of primary and key secondary endpoints at the 0.05 level.|Mixed-Effect Model Repeated Measures||Between-group diff. and 95% CI calculated using ANCOVA/MMRM with RTB-MI for continuous endpoints.|||-0.6326|-1.3285|<0.0001
71834523|NCT02791230|143173160|SUPERIORITY||Hazard Ratio (HR)|0.6202||||0.0001|TWO_SIDED|95.0|0.4865|0.7906|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, Transthyretin (TTR) genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.7906|0.4865|0.0001
71834524|NCT02791230|143173163|SUPERIORITY||Hazard ratio|0.6133||||0.0005|TWO_SIDED|95.0|0.4666|0.8062|||Cox Proportional Hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.|||0.8062|0.4666|0.0005
71665030|NCT02892149|142843797|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.6281|TWO_SIDED|95.0|0.761|1.203|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.203|0.761|0.6281
71744902|NCT01272232|143001120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0008||95.0|1.75|8.41||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||8.41|1.75|0.0008
71834525|NCT01259401|143173178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
71665031|NCT02892149|142843797|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
71665032|NCT02892149|142843798|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96||||0.5811|TWO_SIDED|95.0|0.816|1.136|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0017 has been reported in this section.||1.136|0.816|0.5811
71665033|NCT02892149|142843798|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
71665034|NCT02257385|142843839|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis:the difference between the trt means (umeclidinium/vilanterol minus indacaterol + tiotropium bromide) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium/vilanterol may be deemed statistically non-inferior to indacaterol plus tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, statistical superiority would have been established.|Least Squares Mean Difference|0.001||||0.964|TWO_SIDED|95.0|-0.029|0.03|||Mixed Models Analysis|||||0.030|-0.029|0.964
71665035|NCT02257385|142843840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.023||||0.145|TWO_SIDED|95.0|-0.054|0.008|||Mixed Models Analysis|||||0.008|-0.054|0.145
71744903|NCT01272232|143001120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0099||95.0|1.16|2.95||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.95|1.16|0.0099
71744904|NCT01272232|143001121|SUPERIORITY_OR_OTHER||Treatment contrast|-0.93|||<|0.0001||95.0|-1.08|-0.78||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.78|-1.08|<0.0001
71744905|NCT01272232|143001121|SUPERIORITY_OR_OTHER||Treatment contrast|-0.74|||<|0.0001||95.0|-0.91|-0.57||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.57|-0.91|<0.0001
71744906|NCT01272232|143001121|SUPERIORITY_OR_OTHER||Treatment contrast|-0.19||||0.0125||95.0|-0.34|-0.04||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.04|-0.34|0.0125
71778033|NCT05047770|143055349|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Victoria lineage influenza strain.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.14|0.89|
71665036|NCT02686138|142843842|SUPERIORITY||Risk Difference (RD)|12.85|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71665037|NCT02686138|142843843|SUPERIORITY||Risk Difference (RD)|14.11|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71665038|NCT02686138|142843844|SUPERIORITY||Risk Difference (RD)|11.5||||0.004|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.004
71834526|NCT01259401|143173179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.061|TWO_SIDED||||||ANCOVA|||||||.061
71744907|NCT01272232|143001122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.79|||<|0.0001||95.0|5.74|13.4||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||13.4|5.74|<0.0001
71744908|NCT01272232|143001122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.71|||<|0.0001||95.0|4.76|12.51||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||12.51|4.76|<0.0001
71744909|NCT01272232|143001122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5319||95.0|0.76|1.71||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||1.71|0.76|0.5319
71744910|NCT01272232|143001123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|||<|0.0001||95.0|6.05|15.26||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||15.26|6.05|<0.0001
71744911|NCT01272232|143001123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98|||<|0.0001||95.0|3.59|9.97||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||9.97|3.59|<0.0001
71890968|NCT02240134|143303833|SUPERIORITY||percent differences in geometric mean PM|11.77||||0.295|TWO_SIDED|95.0|-16.57|49.72||Statistical significance selected as 95% confidence interval of the estimation parameter that excludes the null value, 0.|Mixed Models Analysis||Difference in indoor PM2.5 for education treatment versus placebo.|Linear mixed model with natural-log transformed 6-day mean indoor PM2.5 as outcome; assigned treatment as primary exposure variable; adjusted for child age; nested random term: cohort:area. Results presented as effect estimates with 95% Confidence Intervals and reported as percent differences in geometric mean PM2.5.||49.72|-16.57|0.295
71665039|NCT02686138|142843845|SUPERIORITY||Risk Difference (RD)|11.16||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.003
71665040|NCT02686138|142843846|SUPERIORITY||Risk Difference (RD)|10.3||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.01
71665041|NCT02686138|142843847|SUPERIORITY||Risk Difference (RD)|10.17||||0.013|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.013
71834527|NCT04201834|143173191|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
71834528|NCT04201834|143173192|SUPERIORITY|||||||0.92|||||||Paired T-Test|||||||0.92
71834529|NCT04201834|143173193|SUPERIORITY|||||||0.36|||||||Paired T-Test|||||||0.36
71834530|NCT04201834|143173194|SUPERIORITY|||||||0.62|||||||Paired T-Test|||||||0.62
71834531|NCT04201834|143173197|SUPERIORITY|||||||0.11|||||||Paired T-Test|||||||0.11
71834532|NCT04201834|143173198|SUPERIORITY|||||||0.02|||||||Paired T-Test|||||||0.02
71834533|NCT04201834|143173200|SUPERIORITY|||||||0.86|||||||Paired T-Test|||||||0.86
71665042|NCT02686138|142843848|SUPERIORITY||Risk Difference (RD)|13.1|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71665043|NCT02686138|142843849|SUPERIORITY||Risk Difference (RD)|16.18|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71665044|NCT02686138|142843850|SUPERIORITY||Risk Difference (RD)|9.17||||0.015|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.015
71665045|NCT02458287|142843871|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-72.0|-54.7|||Mixed Models Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction as covariates.||-54.7|-72.0|<0.001
71665046|NCT02458287|142843880|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|STANDARD_ERROR_OF_MEAN|4.53|<|0.001|TWO_SIDED|95.0|-51.9|-34.0|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.0|-51.9|<0.001
71665047|NCT02458287|142843881|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.7|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-45.4|-34.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-34.1|-45.4|<0.001
71834534|NCT04201834|143173201|SUPERIORITY|||||||0.27|||||||Paired T-Test|||||||0.27
71834535|NCT04201834|143173202|SUPERIORITY|||||||0.61|||||||Paired T-Test|||||||0.61
71834536|NCT04201834|143173203|SUPERIORITY|||||||0.37|||||||Paired T-Test|||||||0.37
71834537|NCT04201834|143173204|SUPERIORITY|||||||0.3|||||||Paired T-Test|||||||0.30
71834538|NCT04201834|143173205|SUPERIORITY|||||||0.82|||||||Paired t-test|||||||0.82
71834539|NCT04310735|143173209|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the ventromedial prefrontal cortex region of interest.||||||0.13||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||0.13
71834540|NCT04310735|143173209|OTHER|Independent-samples t-tests were conducted to compare the mean contrast of parameter estimate (COPE) values, derived from the contrast of smoking-related versus neutral cue activation, between the Expect-Yes and Expect-No groups in the dorsal anterior cingulate cortex region of interest.||||||0.25||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.25
71834541|NCT04310735|143173210|OTHER|Independent-samples t-tests were conducted to compare mean valence values during smoking-related cues between the Expect-Yes and Expect-No groups.||||||0.8|||||||t-test, 2 sided|Statistical significance was defined a priori as p\<0.05.||The null hypothesis was that there is no difference in the population means of the two groups.||||.80
71834542|NCT04310735|143173210|OTHER|Independent-samples t-tests were conducted to compare mean valence values during neutral cues between the Expect-Yes and Expect-No groups.||||||0.87||||||Statistical significance was defined a priori as p\<0.05.|t-test, 2 sided|||The null hypothesis was that there is no difference in the population means of the two groups.||||.87
71834543|NCT03398200|143173229|SUPERIORITY|||||||0.89|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.89
71834544|NCT03398200|143173230|SUPERIORITY|||||||0.03|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.03
71834545|NCT03398200|143173231|SUPERIORITY|||||||0.35|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.35
71890969|NCT00206726|143303834|SUPERIORITY_OR_OTHER||CR rate|0.0833||||0.014||90.0|0.0334|0.1673||2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate|exact binomial test|||Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval)||0.1673|0.0334|0.014
71665048|NCT02458287|142843881|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.7|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-32.5|-20.8|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-20.8|-32.5|<0.001
71665049|NCT02458287|142843882|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-66.2|-49.5|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-49.5|-66.2|<0.001
71665050|NCT02458287|142843882|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-44.4|-27.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-27.1|-44.4|<0.001
71665051|NCT02458287|142843883|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-63.7|-48.6|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-48.6|-63.7|<0.001
71665052|NCT02458287|142843883|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.2|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-45.0|-29.3|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group \* visit interaction, baseline value, baseline value \* visit interaction as covariates.||-29.3|-45.0|<0.001
71665053|NCT02800642|142843891|OTHER||||||<|0.0001|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a ≥ 15-letter gain in BCVA at Week 76 is ≤ 40% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||<0.0001
71665054|NCT02800642|142843892|OTHER||||||=|0.8822|||||||Exact one-sided 1-sample binomial test|||"The null hypothesis the proportion of participants with a mean treatment interval of ≥ 8 weeks is ≤ 50% on the 2.5% level of significance (one-sided) was performed using the following criterion: If the p value is less than 2.5%, the null hypothesis will be rejected. Otherwise, the null hypothesis will be regarded as not rejected and may still be true"||||=0.8822
71665055|NCT00517556|142843900|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71665056|NCT02521376|142843990|OTHER||Geometric Mean Ratio (GMR)|43.69|||||TWO_SIDED|90.0|24.59|77.62||||||||77.62|24.59|
71778034|NCT05047770|143055349|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMT ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-HI antibody titer was \<1.5 for the B/Yamagata lineage influenza strain.|GMT Ratio|1.04|||||TWO_SIDED|95.0|0.93|1.17|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of anti-HI GMTs against the B/Yamagata lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||1.17|0.93|
71665057|NCT02521376|142843990|OTHER||GMR|233.63|||||TWO_SIDED|90.0|141.85|384.79||||||||384.79|141.85|
71665058|NCT02521376|142843990|OTHER||GMR|219.2|||||TWO_SIDED|90.0|139.74|343.84||||||||343.84|139.74|
71665059|NCT02521376|142843990|OTHER||GMR|108.5|||||TWO_SIDED|90.0|77.2|152.48||||||||152.48|77.20|
71665060|NCT02521376|142843991|OTHER||GMR|55.71|||||TWO_SIDED|90.0|34.7|89.42||||||||89.42|34.70|
71665061|NCT02521376|142843991|OTHER||GMR|211.94|||||TWO_SIDED|90.0|132.49|339.03||||||||339.03|132.49|
71665062|NCT02521376|142843991|OTHER||GMR|171.33|||||TWO_SIDED|90.0|108.17|271.37||||||||271.37|108.17|
71665063|NCT02521376|142843991|OTHER||GMR|107.35|||||TWO_SIDED|90.0|72.71|158.51||||||||158.51|72.71|
71665064|NCT03597464|142843997|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.05|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||4.05|1.30|0.004
71665065|NCT03597464|142843997|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.25|3.83|||Regression, Logistic|||Month 18||3.83|1.25|0.006
71665066|NCT03597464|142843997|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.81||||0.035|TWO_SIDED|95.0|1.04|3.16|||Regression, Logistic|||Month 24||3.16|1.04|0.035
71778035|NCT05047770|143055350|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the adjusted GMC ratio between FluD-QIVSeq group and FluD-QIVCoAd group for anti-S antibody concentration was \<1.5.|GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of mRNA-1273 booster when co-administered with Flu D-QIV vaccine compared to mRNA-1273 booster dose administered alone in terms of anti-S protein GMCs, at 1 month post-mRNA-1273 booster dose administration (at Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups).||1.13|0.84|
71778036|NCT05047770|143055351|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.6|||||TWO_SIDED|95.0|-5.1|6.4|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H1N1 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||6.4|-5.1|
71665067|NCT03597464|142843997|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.28|3.92|||Regression, Logistic|||Month 30||3.92|1.28|0.005
71665068|NCT03597464|142843997|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.74||||0.051|TWO_SIDED|95.0|1.0|3.03|||Regression, Logistic|||Month 36||3.03|1.00|0.051
71665069|NCT03597464|142843998|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.88|8.46|||Regression, Logistic|||Month 12 (AURORA 2 baseline)||8.46|1.88|<0.001
71665070|NCT03597464|142843998|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.5||||0.008|TWO_SIDED|95.0|1.28|4.88|||Regression, Logistic|||Month 18||4.88|1.28|0.008
71665071|NCT03597464|142843998|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|2.68||||0.001|TWO_SIDED|95.0|1.46|4.91|||Regression, Logistic|||Month 24||4.91|1.46|0.001
71665072|NCT03597464|142843998|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.86||||0.04|TWO_SIDED|95.0|1.03|3.34|||Regression, Logistic|||Month 30||3.34|1.03|0.040
71665073|NCT03597464|142843998|OTHER|"The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and region.~Subjects who withdrew from the study prior to the visit assessments and thus provide insufficient visit data were defined as non-responders."|Odds Ratio (OR)|1.39||||0.29|TWO_SIDED|95.0|0.75|2.58|||Regression, Logistic|||Month 36||2.58|0.75|0.290
71665074|NCT03597464|142843999|OTHER||Odds Ratio (OR)|0.56||||0.045|TWO_SIDED|95.0|0.32|0.99|||Regression, Logistic|||Number of subjects with adequate renal response. This model is based on a logistic regression with terms for treatment, baseline urine protein creatinine ratio (UPCR), biopsy class, mycophenolate mofetil (MMF) use at baseline and region. An odds ratio \< unity indicates benefit for voclosporin.||0.99|0.32|0.045
71665075|NCT03597464|142844000|SUPERIORITY||Least Squares Mean difference|-0.8||||0.238|TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||Month 18||0.5|-2.1|0.238
71665076|NCT03597464|142844000|SUPERIORITY||Least Squares Mean difference|-0.7||||0.215|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||Month 24||0.4|-1.8|0.215
71778037|NCT05047770|143055351|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.3|||||TWO_SIDED|95.0|-7.8|5.2|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the A/H3N2 influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.2|-7.8|
71665077|NCT03597464|142844000|SUPERIORITY||Least Squares Mean difference|-0.7||||0.246|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|||Month 36||0.5|-1.8|0.246
71665078|NCT03597464|142844001|SUPERIORITY||Least Squares Mean difference|-0.65||||0.001|TWO_SIDED|95.0|-1.05|-0.26|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.26|-1.05|0.001
71665079|NCT03597464|142844001|SUPERIORITY||Least Squares Mean difference|-0.63||||0.029|TWO_SIDED|95.0|-1.2|-0.07|||Mixed Models Analysis|||Month 18||-0.07|-1.20|0.029
71665080|NCT03597464|142844001|SUPERIORITY||Least Squares Mean difference|-0.77||||0.002|TWO_SIDED|95.0|-1.24|-0.29|||Mixed Models Analysis|||Month 24||-0.29|-1.24|0.002
71665081|NCT03597464|142844001|SUPERIORITY||Least Squares Mean difference|-0.91||||0.002|TWO_SIDED|95.0|-1.49|-0.33|||Mixed Models Analysis|||Month 30||-0.33|-1.49|0.002
71665082|NCT03597464|142844001|SUPERIORITY||Least Squares Mean difference|-0.48||||0.106|TWO_SIDED|95.0|-1.06|-0.1|||Mixed Models Analysis|||Month 36||-0.10|-1.06|0.106
71665083|NCT03597464|142844002|SUPERIORITY||Least Squares Mean difference|-2.7||||0.041|TWO_SIDED|95.0|-5.3|-0.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-0.1|-5.3|0.041
71665084|NCT03597464|142844002|SUPERIORITY||Least Squares Mean difference|-1.8||||0.292|TWO_SIDED|95.0|-5.1|1.6|||Mixed Models Analysis|||Month 18||1.6|-5.1|0.292
71665085|NCT03597464|142844002|SUPERIORITY||Least Squares Mean difference|-2.2||||0.282|TWO_SIDED|95.0|-6.1|1.8|||Mixed Models Analysis|||Month 24||1.8|-6.1|0.282
71665086|NCT03597464|142844002|SUPERIORITY||Least Squares Mean difference|0.9||||0.659|TWO_SIDED|95.0|-3.2|5.1|||Mixed Models Analysis|||Month 30||5.1|-3.2|0.659
71665087|NCT03597464|142844002|SUPERIORITY||Least Squares Mean difference|1.8||||0.438|TWO_SIDED|95.0|-2.8|6.4|||Mixed Models Analysis|||Month 36||6.4|-2.8|0.438
71778038|NCT05047770|143055351|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|0.1|||||TWO_SIDED|95.0|-5.8|5.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Victoria lineage influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||5.9|-5.8|
71890970|NCT05067127|143303900|SUPERIORITY||Difference in least squares (LS) mean|-1.143|||<|0.0001|TWO_SIDED|95.0|-1.436|-0.85|||MMRM|||An mixed-effect model for repeated measures (MMRM) including fixed categorical effect for treatment group, visit, disease type, baseline immunosuppressants use, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline log-transformed uPCR, was utilized to analyze the log-transformed ratio of uPCR at Week 26 compared to baseline.||-0.85|-1.436|<0.0001
71890971|NCT05067127|143303901|SUPERIORITY||Odds Ratio (OR)|27.516|||<|0.0001|TWO_SIDED|95.0|6.105|124.026|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline eGFR values, baseline log-transformed uPCR values, disease type, and stratification factors.||124.026|6.105|<0.0001
71890972|NCT05067127|143303902|SUPERIORITY||Odds Ratio (OR)|30.932|||<|0.0001|TWO_SIDED|95.0|8.401|113.897|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline log-transformed uPCR values, disease type, and stratification factors.||113.897|8.401|<0.0001
71890973|NCT05067127|143303903|SUPERIORITY||Difference in LS mean|-1.002||||0.2753|TWO_SIDED|95.0|-2.803|0.798|||ANCOVA|||Analysis of covariance (ANCOVA) model included treatment as fixed effect, adjusted for baseline C3G histologic index activity score, disease type, and stratification factors.||0.798|-2.803|0.2753
71890974|NCT05067127|143303904|SUPERIORITY||Odds Ratio (OR)|27.392|||<|0.0001|TWO_SIDED|95.0|6.477|115.852|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3c staining, disease type, and stratification factors.||115.852|6.477|<0.0001
71665088|NCT03597464|142844003|SUPERIORITY||Least Squares Mean difference|-67.7||||0.002|TWO_SIDED|95.0|-110.4|-25.1|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||-25.1|-110.4|0.002
71890975|NCT05067127|143303905|SUPERIORITY||Difference in LS mean|6.312||||0.0333|TWO_SIDED|95.0|0.501|12.122|||MMRM|||An MMRM model included fixed categorical effect for treatment group, visit, disease type, stratification factors, and the visit-by-treatment group interactions as well as the continuous, fixed covariate of baseline eGFR, was utilized to analyze the mean change from baseline to Week 26 in eGFR.||12.122|0.501|0.0333
71890976|NCT05067127|143303906|SUPERIORITY||Odds Ratio (OR)|5.753||||0.0006|TWO_SIDED|95.0|2.106|15.716|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline proteinuria values, disease type, and stratification factors.||15.716|2.106|0.0006
71890977|NCT05067127|143303907|SUPERIORITY||Odds Ratio (OR)|88.341||||0.0001|TWO_SIDED|95.0|8.863|880.544|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline albumin values, disease type, and stratification factors.||880.544|8.863|0.0001
71890978|NCT05067127|143303908|SUPERIORITY||Odds Ratio (OR)|999.999||||0.0094|TWO_SIDED|95.0|12.175|9999.999|||Logistic|||The logistic model included treatment group as independent variable and adjusted for baseline C3 levels, stratification factors and disease type.||9999.999|12.175|0.0094
71890979|NCT05067127|143303909|SUPERIORITY||Difference in LS mean|0.562||||0.7384|TWO_SIDED|95.0|-2.739|3.863|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||3.863|-2.739|0.7384
71890980|NCT05067127|143303910|SUPERIORITY||Difference in LS mean|1.345||||0.5648|TWO_SIDED|95.0|-3.237|5.927|||ANCOVA|||The ANCOVA model included treatment as fixed effect, adjusted for baseline, disease type, and stratification factors.||5.927|-3.237|0.5648
71890981|NCT01499173|143303916|SUPERIORITY||||||<|0.01||||||Actual p value shown here; not threshold.|multilevel linear regression|||||||<0.01
71890982|NCT01499173|143303917|SUPERIORITY|||||||0.34|||||||multilevel linear regression|||||||0.34
71890983|NCT01499173|143303918|OTHER|odds ratio|Odds Ratio (OR)|-0.5|||||TWO_SIDED|||||||||Odds ratio was calculated for each question comparing 1 week data with 1 month data||||
71890984|NCT00054847|143303969|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.82|TWO_SIDED|95.0|0.62|1.84||Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.|Chi-squared|We performed as-treated and per-protocol analyses \& multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.||The study was designed to have 90% power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5%and an expected 1-year catheterization completion rate of 65%.||1.84|.62|.82
71890985|NCT00054847|143303970|SUPERIORITY_OR_OTHER|||||||0.61|||||||Chi-squared|||||||.61
71890986|NCT00054847|143303971|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>.99
71665089|NCT03597464|142844003|SUPERIORITY||Least Squares Mean difference|-87.7||||0.007|TWO_SIDED|95.0|-151.2|-24.2|||Mixed Models Analysis|||Month 18||-24.2|-151.2|0.007
71665090|NCT03597464|142844003|SUPERIORITY||Least Squares Mean difference|-47.0||||0.035|TWO_SIDED|95.0|-90.8|-3.3|||Mixed Models Analysis|||Month 24||-3.3|-90.8|0.035
71665091|NCT03597464|142844003|SUPERIORITY||Least Squares Mean difference|-73.1||||0.005|TWO_SIDED|95.0|-123.5|-22.6|||Mixed Models Analysis|||Month 30||-22.6|-123.5|0.005
71665092|NCT03597464|142844003|SUPERIORITY||Least Squares Mean difference|-19.0||||0.537|TWO_SIDED|95.0|-79.7|41.7|||Mixed Models Analysis|||Month 36||41.7|-79.7|0.537
71665093|NCT03597464|142844004|SUPERIORITY||Least Squares Mean difference|0.084|||<|0.001|TWO_SIDED|95.0|0.035|0.134|||Mixed Models Analysis|||Month 12 (AURORA 2 baseline)||0.134|0.035|<0.001
71665094|NCT03597464|142844004|SUPERIORITY||Least Squares Mean difference|0.051||||0.209|TWO_SIDED|95.0|-0.029|0.131|||Mixed Models Analysis|||Month 18||0.131|-0.029|0.209
71665095|NCT03597464|142844004|SUPERIORITY||Least Squares Mean difference|0.057||||0.353|TWO_SIDED|95.0|-0.064|0.178|||Mixed Models Analysis|||Month 24||0.178|-0.064|0.353
71665096|NCT03597464|142844004|SUPERIORITY||Least Squares Mean difference|-0.036||||0.616|TWO_SIDED|95.0|-0.176|0.105|||Mixed Models Analysis|||Month 30||0.105|-0.176|0.616
71665097|NCT03597464|142844004|SUPERIORITY||Least Squares Mean difference|-0.077||||0.372|TWO_SIDED|95.0|-0.248|0.094|||Mixed Models Analysis|||Month 36||0.094|-0.248|0.372
71665098|NCT00676780|142844028|SUPERIORITY_OR_OTHER||||||=|0.027||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.027
71665099|NCT00676780|142844029|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.023
71665100|NCT00676780|142844030|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is no change, i.e. median change = 0.0||||<0.001
71834546|NCT03398200|143173232|SUPERIORITY|||||||0.77|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.77
71665101|NCT02682927|142844031|SUPERIORITY||Percentage difference from Placebo|62.29|||||TWO_SIDED|95.0|47.72|72.8|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||72.80|47.72|
71665102|NCT02682927|142844031|SUPERIORITY||Percentage difference from Placebo|64.75|||||TWO_SIDED|95.0|51.85|74.19|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||74.19|51.85|
71665103|NCT02682927|142844032|SUPERIORITY||Percentage difference from Placebo|32.43|||||TWO_SIDED|95.0|6.19|51.33|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||51.33|6.19|
71665104|NCT02682927|142844032|SUPERIORITY||Percentage difference from Placebo|49.88|||||TWO_SIDED|95.0|31.31|63.43|||||Estimate was obtained from the LSMeans on the log scale as follows: 100 x \[1 - exp(LS mean active - LS mean placebo).|||63.43|31.31|
71665105|NCT02682927|142844034|SUPERIORITY||Odds Ratio (OR)|4.773||||0.009|TWO_SIDED|95.0|1.475|15.45|||Regression, Logistic|||||15.450|1.475|0.009
71665106|NCT02682927|142844034|SUPERIORITY||Odds Ratio (OR)|14.96|||<|0.001|TWO_SIDED|95.0|4.484|49.915|||Regression, Logistic|||||49.915|4.484|<0.001
71665107|NCT02682927|142844034|SUPERIORITY||Odds Ratio (OR)|13.4||||0.0001|TWO_SIDED|95.0|3.6|49.8|||Regression, Logistic|||||49.8|3.6|0.0001
71665108|NCT02682927|142844034|SUPERIORITY||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|12.9|220.5|||Regression, Logistic|||||220.5|12.9|<0.0001
71665109|NCT02682927|142844037|SUPERIORITY|||||||0.035|||||||Wilcoxon rank sum test|||||||0.035
71665110|NCT02682927|142844037|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71665111|NCT02682927|142844037|SUPERIORITY||Comparing active with placebo|||||0.0002|||||||Wilcoxon rank sum test|||||||0.0002
71665112|NCT02682927|142844037|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
71665113|NCT01613313|142844066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||No p value||This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.||||
71665114|NCT01613313|142844067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|||||||||This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.||||
71665115|NCT02766283|142844075|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
71665116|NCT02766283|142844076|SUPERIORITY_OR_OTHER|||||||0.022|||||||Chi-squared|||||||0.022
71665117|NCT04007991|142844083|SUPERIORITY||Difference in Least Square Mean|-3.44|STANDARD_ERROR_OF_MEAN|1.351|=|0.011|TWO_SIDED|95.0|-6.09|-0.79||Change from baseline in YGTSS score as a continuous variable was based on mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) model with an unstructured covariance matrix.|ANCOVA|||||-0.79|-6.09|=0.011
71665118|NCT03888066|142844098|SUPERIORITY||Mean Difference (Final Values)|-0.097|STANDARD_ERROR_OF_MEAN|0.015|<|0.001|TWO_SIDED|95.0|-0.128|-0.067|||Mixed model for repeated measures (MMRM)|||Difference in adjusted mean changes (SE)||-0.067|-0.128|< 0.001
71665119|NCT03888066|142844099|SUPERIORITY||Hazard Ratio (HR)|0.63|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
71665120|NCT03888066|142844100|SUPERIORITY||Hazard Ratio (HR)|0.62|||=|0.006|TWO_SIDED|95.0|0.45|0.87||Threshold for statistical significance = 0.05|Regression, Cox|||"Hazard Ratio patiromer vs placebo.~The HR for the time to first hyperkalemia event for patiromer vs placebo was calculated. HR and p-value come from a Cox proportional regression model adjusted for geographic region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR.~HR = Hazard Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.87|0.45|= 0.006
71665121|NCT03888066|142844101|SUPERIORITY||Annualized event rate ratio|0.658|||<|0.001|TWO_SIDED|95.0|0.534|0.81|||Negative binomial model adjusted for cov|||"NBMAC Annualized event RR patiromer vs placebo.~NBMAC adjusted for geographical region, sex, Baseline T2DM status, Baseline K+ value, and Baseline eGFR. Rate ratio less than 1 favors patiromer.~NBMAC=Negative binomial model adjusted for covariates; RR=Rate Ratio; T2DM=Type 2 diabetes mellitus; eGFR=Estimated glomerular filtration rate"||0.81|0.534|< 0.001
71834547|NCT03398200|143173233|SUPERIORITY|||||||0.5|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.50
71665122|NCT03888066|142844102|SUPERIORITY||Win Ratio|1.526|||<|0.001|TWO_SIDED|95.0|1.231|1.906|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers."||1.906|1.231|<0.001
71665123|NCT03888066|142844102|SUPERIORITY||Win Ratio|0.914|||=|0.744|TWO_SIDED|95.0|0.526|1.578|||Win Ratio|||"Win ratio CV death and hospitalization.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.578|0.526|= 0.744
71665124|NCT03888066|142844103|SUPERIORITY||Win Ratio|1.248|||=|0.048|TWO_SIDED|95.0|1.003|1.564|||Win Ratio|||"Win ratio for composite.~Win ratio approach: Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labelled winner/loser depending on CV/hyperkalemia event first. The win ratio is the total number of winners divided by the total numbers of losers. Unmatched win ratio is presented for this endpoint. Win ratio above 1 favors patiromer."||1.564|1.003|= 0.048
71665125|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.001||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrilysin (P09237) was analyzed.||||= 0.001
71665126|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.002||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of von Willebrand factor (P04275) was analyzed.||||= 0.002
71665127|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 4 (O95388) was analyzed.||||= 0.044
71665128|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.044||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta-1 proprotein (P01137) was analyzed.||||= 0.044
71665129|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.127||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TGF beta receptor type 3 (Q03167) was analyzed.||||= 0.127
71665130|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.21||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of IL-15 receptor subunit alpha (Q13261) was analyzed.||||= 0.210
71778039|NCT05047770|143055351|NON_INFERIORITY|The non-inferiority was to be concluded if the UL of the 95% CI of the difference in percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain between FluD-QIVSeq group and FluD-QIVCoAd group was \< 10%.|Difference in percentage|-1.6|||||TWO_SIDED|95.0|-7.0|3.9|||ANCOVA|||To demonstrate the non-inferiority of humoral immunogenicity of 1 dose of Flu D-QIV vaccine when co-administered with mRNA-1273 booster dose compared to Flu D-QIV vaccine administered alone, in terms of percentage of participants seroconverted for anti-HI antibodies against the B/Yamagata influenza strain included in the Flu D-QIV vaccine, at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group).||3.9|-7.0|
71778040|NCT04289623|143055391|SUPERIORITY||Odds Ratio (OR)|1.19||||0.007|TWO_SIDED|95.0|1.05|1.35||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.35|1.05|.007
71778041|NCT04289623|143055391|SUPERIORITY||Odds Ratio (OR)|0.82||||0.287|TWO_SIDED|95.0|0.56|1.19||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.19|0.56|.287
71778042|NCT04289623|143055391|SUPERIORITY||Odds Ratio (OR)|1.05||||0.59|TWO_SIDED|95.0|0.87|1.27||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.27|0.87|.590
71778043|NCT04289623|143055391|SUPERIORITY||Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.05|3.32||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||3.32|1.05|.035
71778044|NCT04289623|143055392|SUPERIORITY||Odds Ratio (OR)|1.16||||0.085|TWO_SIDED|95.0|0.98|1.37||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the standard email as the reference group.||1.37|0.98|.085
71665131|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Metalloproteinase inhibitor 1 (P01033) was analyzed.||||= 0.215
71665132|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.215||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Pappalysin-1 (Q13219) was analyzed.||||= 0.215
71665133|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.745||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Proto-oncogene c-Src (P12931) was analyzed.||||= 0.745
71665134|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Protein AMBP (P02760) was analyzed.||||= 0.762
71665135|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Uromodulin (P07911) was analyzed.||||= 0.762
71665136|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Aminopeptidase N (P15144) was analyzed.||||= 0.762
71665137|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.762||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of TNFRSF1A (P19438) was analyzed.||||= 0.762
71665138|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Plasminogen activator inhibitor 1 (P05121) was analyzed.||||= 0.917
71665139|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of CCN family member 2 (P29279) was analyzed.||||= 0.917
71665140|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of uPAR (Q03405) was analyzed.||||= 0.917
71665141|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.917||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 14 (Q16627) was analyzed.||||= 0.917
71665142|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 16 (O15467) was analyzed.||||= 0.979
71665143|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Collagen alpha-1(I) chain (P02452) was analyzed.||||= 0.979
71834548|NCT03398200|143173234|SUPERIORITY|||||||0.76|||||||Regression, Cox|1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model||||||0.76
71744912|NCT01272232|143001123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.0142||95.0|1.1|2.34||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||2.34|1.10|0.0142
71744913|NCT01272232|143001124|SUPERIORITY_OR_OTHER||Treatment contrast|-3.22|||<|0.0001||95.0|-4.2|-2.23||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-2.23|-4.20|<0.0001
71744914|NCT01272232|143001124|SUPERIORITY_OR_OTHER||Treatment contrast|-2.06||||0.0004||95.0|-3.2|-0.92||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.92|-3.20|0.0004
71744915|NCT01272232|143001124|SUPERIORITY_OR_OTHER||Treatment contrast|-1.16||||0.0224||95.0|-2.16|-0.16||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.16|-2.16|0.0224
71744916|NCT01272232|143001125|SUPERIORITY_OR_OTHER||Treatment contrast|-2.17||||0.0002||95.0|-3.32|-1.02||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.02|-3.32|0.0002
71744917|NCT01272232|143001125|SUPERIORITY_OR_OTHER||Treatment contrast|-1.2||||0.0725||95.0|-2.51|0.11||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.11|-2.51|0.0725
71778045|NCT04289623|143055392|SUPERIORITY||Odds Ratio (OR)|0.89||||0.569|TWO_SIDED|95.0|0.6|1.33||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the standard email as the reference group.||1.33|0.60|.569
71778046|NCT04289623|143055392|SUPERIORITY||Odds Ratio (OR)|0.79||||0.24|TWO_SIDED|95.0|0.54|1.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the previously enrolled group with the rank-and-file email as the reference group.||1.17|0.54|.240
71778047|NCT04289623|143055392|SUPERIORITY||Odds Ratio (OR)|0.94||||0.871|TWO_SIDED|95.0|0.45|1.95||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression among the never enrolled group with the rank-and-file email as the reference group.||1.95|0.45|.871
71778048|NCT03758443|143055393|SUPERIORITY||Least Square Mean Difference|-0.27||||0.5809|TWO_SIDED|95.0|-1.22|0.69|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.69|-1.22|0.5809
71778049|NCT03758443|143055393|SUPERIORITY||Least Square Mean Difference|-0.37||||0.4501|TWO_SIDED|95.0|-1.33|0.59|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.59|-1.33|0.4501
71778050|NCT03758443|143055393|SUPERIORITY||Least Square Mean Difference|-0.65||||0.1809|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA|||Least square estimates, 95% CI, and p-values were obtained by fitting an ANCOVA model with terms for treatment, steroid use at baseline (yes, no) and prior biologic failure (yes, no), and baseline total Mayo score as covariate.||0.30|-1.60|0.1809
71744918|NCT01272232|143001125|SUPERIORITY_OR_OTHER||Treatment contrast|-0.97||||0.0717||95.0|-2.02|0.09||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.09|-2.02|0.0717
71744919|NCT01272232|143001127|SUPERIORITY_OR_OTHER||Treatment contrast|-2.49|||<|0.0001||95.0|-3.75|-1.24||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-1.24|-3.75|<0.0001
71744920|NCT01272232|143001127|SUPERIORITY_OR_OTHER||Treatment contrast|-1.47||||0.0457||95.0|-2.92|-0.03||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||-0.03|-2.92|0.0457
71744921|NCT01272232|143001127|SUPERIORITY_OR_OTHER||Treatment contrast|-1.02||||0.0961||95.0|-2.22|0.18||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.||0.18|-2.22|0.0961
71744922|NCT00255190|143001143|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.042
71744923|NCT00255190|143001144|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.006
71744924|NCT00255190|143001145|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using a one-way analysis of covariance (ANCOVA) model with treatment as the factor and baseline score as the covariate.||||||0.204
71744925|NCT00255190|143001146|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.109
71744926|NCT00255190|143001147|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
71665144|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Decorin (P07585) was analyzed.||||= 0.979
71665145|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of C-C motif chemokine 2 (P13500) was analyzed.||||= 0.979
71665146|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Matrix metalloproteinase-9 (P14780) was analyzed.||||= 0.979
71665147|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX differences (corresponding to log-transformed ratio to baseline) of E-selectin (P16581) was analyzed.||||= 0.979
71665148|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Thrombospondin-2 (P35442) was analyzed.||||= 0.979
71744927|NCT00255190|143001148|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.494
71778051|NCT03758443|143055394|SUPERIORITY|||||||0.3762|||||||Fisher Exact|||||||0.3762
71834549|NCT05478525|143173236|SUPERIORITY||Least Squares (LS) Mean Difference|-35.05||||0.0007|TWO_SIDED|95.0|-54.35|-15.75|||ANCOVA|||Analysis at Week 2||-15.75|-54.35|0.0007
71778052|NCT03758443|143055394|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778053|NCT03758443|143055394|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778054|NCT03758443|143055395|SUPERIORITY||Difference in Proportion|0.0||||0.9542|TWO_SIDED|95.0|-0.104|0.11||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.110|-0.104|0.9542
71778055|NCT03758443|143055395|SUPERIORITY||Difference in Proportion|-0.03||||0.5863|TWO_SIDED|95.0|-0.126|0.071||P-value is shown for Cochran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.071|-0.126|0.5863
71778056|NCT03758443|143055395|SUPERIORITY||Difference in Proportion|-0.03||||0.5408|TWO_SIDED|95.0|-0.131|0.069||P-value is shown for Conhran-Mantel Haenszel tests stratified by prior biologic failure and steroid use at baseline.|Cochran-Mantel-Haenszel||Difference in proportion estimates used Mantel-Haenszel stratum weights.|||0.069|-0.131|0.5408
71778057|NCT03758443|143055396|SUPERIORITY|||||||0.6656|||||||Fisher Exact|||||||0.6656
71778058|NCT03758443|143055396|SUPERIORITY|||||||0.6424|||||||Fisher Exact|||||||0.6424
71778059|NCT03758443|143055396|SUPERIORITY|||||||0.6199|||||||Fisher Exact|||||||0.6199
71778060|NCT03758443|143055397|SUPERIORITY|||||||0.2643|||||||Fisher Exact|||||||0.2643
71778061|NCT03758443|143055397|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778062|NCT03758443|143055397|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778063|NCT03758443|143055398|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778064|NCT03758443|143055398|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778065|NCT03758443|143055398|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778066|NCT01436396|143055399|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|0.334|||||TWO_SIDED|95.0|-0.976|1.87||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||1.87|-0.976|
71778067|NCT01436396|143055400|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|-1.06|||||TWO_SIDED|95.0|-2.81|0.383||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).||0.383|-2.81|
71778068|NCT00694707|143055444|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.5||||0.0005|TWO_SIDED|95.0|-11.8|-3.3|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-3.3|-11.8|0.0005
71778069|NCT00694707|143055444|SUPERIORITY_OR_OTHER||Least squares mean difference|-8.8|||<|0.0001|TWO_SIDED|95.0|-13.1|-4.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-4.6|-13.1|<0.0001
71778070|NCT00694707|143055444|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.6|-6.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-6.2|-14.6|<0.0001
71665149|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of RARRES2 (Q99969) was analyzed.||||= 0.979
71834550|NCT05478525|143173236|SUPERIORITY||LS Mean Difference|-23.14||||0.0193|TWO_SIDED|95.0|-42.32|-3.97|||ANCOVA|||Analysis at Week 2||-3.97|-42.32|0.0193
71744928|NCT00255190|143001149|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.026
71744929|NCT00255190|143001150|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.220
71744930|NCT00255190|143001151|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.843
71744931|NCT00255190|143001152|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.923
71744932|NCT00255190|143001153|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||<0.001
71744933|NCT00255190|143001154|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.758
71744934|NCT00255190|143001155|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.737
71744935|NCT00255190|143001156|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.673
71744936|NCT00255190|143001157|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.817
71744937|NCT00255190|143001158|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.601
71744938|NCT00255190|143001159|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.065
71744939|NCT00255190|143001160|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.319
71744940|NCT00255190|143001161|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.011
71744941|NCT00255190|143001162|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA|||||||0.207
71744942|NCT00255190|143001163|SUPERIORITY_OR_OTHER|||||||0.286||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.286
71744943|NCT00255190|143001164|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.102
71744944|NCT00255190|143001165|SUPERIORITY_OR_OTHER|||||||0.656||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.656
71744945|NCT00255190|143001166|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.176
71744946|NCT00255190|143001167|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.030
71744947|NCT00255190|143001168|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.243
71744948|NCT00255190|143001169|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.005
71665150|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of C-X-C motif chemokine 16 (Q9H2A7) was analyzed.||||= 0.979
71744949|NCT00255190|143001170|SUPERIORITY_OR_OTHER|||||||0.469||95.0||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.||||||0.469
71744950|NCT00628030|143001173|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Chi-squared|||||||.008
71744951|NCT00628030|143001174|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Chi-squared|||||||.041
71744952|NCT00628030|143001175|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Chi-squared|||||||.61
71744953|NCT00628030|143001176|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
71744954|NCT00628030|143001177|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||||||.024
71744955|NCT03367858|143001182|SUPERIORITY|||||||0.0173||||||At 12 month follow up.|ANCOVA|||We conducted a repeated measures ANCOVA of Time (Post-Treatment: 3, 6, 12 months) × Treatment (MI, BAM) with the covariate of pre-treatment problem drinking.||||.0173
71744956|NCT03827655|143001183|SUPERIORITY||Hazard Ratio (HR)|0.92|||=|0.649|TWO_SIDED|90.0|0.63|1.33||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% confidence intervals (CIs) and associated Wald Chi-square p-values between TAK-954 dose levels and placebo were obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.33|0.63|=0.649
71744957|NCT03827655|143001183|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.505|TWO_SIDED|90.0|0.69|1.43||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.43|0.69|=0.505
71778071|NCT00694707|143055444|SUPERIORITY_OR_OTHER||Least squares mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.||||-10.8|-19.4|<0.0001
71778072|NCT00694707|143055445|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.4||||0.004|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.1|-0.6|0.0040
71834551|NCT05478525|143173236|SUPERIORITY||LS Mean Difference|-21.64||||0.0243|TWO_SIDED|95.0|-40.33|-2.96|||ANCOVA|||Analysis at Week 2||-2.96|-40.33|0.0243
71778073|NCT00694707|143055445|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.5||||0.0003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.2|-0.7|0.0003
71778074|NCT00694707|143055445|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.4|-0.9|<0.0001
71778075|NCT00694707|143055445|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.||||-0.6|-1.1|<0.0001
71778076|NCT00973674|143055450|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Barnard's unconditional Exact Test|||||||0.99
71778077|NCT00973674|143055451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.67||||0.033|TWO_SIDED|95.0|0.74|3.77|||Log Rank|||||3.77|0.74|.033
71778078|NCT00973674|143055452|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|||||||t-test, 2 sided|||||||.35
71778079|NCT02713204|143055454|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|0.02||||0.9894|TWO_SIDED|95.0|-2.99|3.03||Threshold for significance at 0.05 level.|ANCOVA|||||3.03|-2.99|0.9894
71778080|NCT02713204|143055454|SUPERIORITY||Least square mean difference|0.25||||0.8346|TWO_SIDED|95.0|-2.09|2.59|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.59|-2.09|0.8346
71778081|NCT02713204|143055455|SUPERIORITY||Least square mean difference|-1.2||||0.4611|TWO_SIDED|95.0|-4.41|2.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.00|-4.41|0.4611
71778082|NCT02713204|143055455|SUPERIORITY|Threshold for significance at 0.05 level.|Least square mean difference|-2.0||||0.2225|TWO_SIDED|95.0|-5.22|1.22|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.22|-5.22|0.2225
71778083|NCT02713204|143055455|SUPERIORITY||Least square mean difference|-0.82||||0.6063|TWO_SIDED|95.0|-3.97|2.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.32|-3.97|0.6063
71778084|NCT02713204|143055455|SUPERIORITY||Least square mean difference|-3.25||||0.0426|TWO_SIDED|95.0|-6.39|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.11|-6.39|0.0426
71778085|NCT02713204|143055455|SUPERIORITY||Least square mean difference|-4.39||||0.0073|TWO_SIDED|95.0|-7.58|-1.19||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-1.19|-7.58|0.0073
71778086|NCT02713204|143055455|SUPERIORITY||Least square mean difference|1.17||||0.469|TWO_SIDED|95.0|-2.01|4.36||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.36|-2.01|0.4690
71778087|NCT02713204|143055455|SUPERIORITY||Least square mean difference|2.42||||0.1267|TWO_SIDED|95.0|-0.69|5.54||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.54|-0.69|0.1267
71778088|NCT02713204|143055456|SUPERIORITY||Least square mean difference|-11.57||||0.413|TWO_SIDED|95.0|-39.5|16.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.20|-39.5|0.4130
71778089|NCT02713204|143055456|SUPERIORITY||Least square mean difference|-4.88||||0.6587|TWO_SIDED|95.0|-26.2|16.85|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||16.85|-26.2|0.6587
71778090|NCT02713204|143055457|SUPERIORITY||Least square mean difference|17.04||||0.3833|TWO_SIDED|95.0|-21.35|55.43||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||55.43|-21.35|0.3833
71778091|NCT02713204|143055457|SUPERIORITY||Least square mean difference|12.85||||0.5141|TWO_SIDED|95.0|-25.84|51.53||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||51.53|-25.84|0.5141
71778092|NCT02713204|143055457|SUPERIORITY||Least square mean difference|33.89||||0.0785|TWO_SIDED|95.0|-3.89|71.67|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||71.67|-3.89|0.0785
71778093|NCT02713204|143055457|SUPERIORITY||Least square mean difference|42.27||||0.0281|TWO_SIDED|95.0|4.56|79.98||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||79.98|4.56|0.0281
71778094|NCT02713204|143055457|SUPERIORITY||Least square mean difference|16.65||||0.3934|TWO_SIDED|95.0|-21.67|54.96||Threshold for significance at 0.05 level.|ANCOVA|||||54.96|-21.67|0.3934
71778095|NCT02713204|143055457|SUPERIORITY||Least square mean difference|21.05||||0.279|TWO_SIDED|95.0|-17.13|59.22||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||59.22|-17.13|0.2790
71778096|NCT02713204|143055457|SUPERIORITY||Least square mean difference|-8.38||||0.6586|TWO_SIDED|95.0|-45.64|28.88||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||28.88|-45.64|0.6586
71778097|NCT02713204|143055458|SUPERIORITY||Least square mean difference|0.55||||0.4889|TWO_SIDED|95.0|-1.01|2.1||Threshold for significance at 0.05 level.|ANCOVA|||||2.10|-1.01|0.4889
71744958|NCT03827655|143001184|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.449|TWO_SIDED|90.0|0.71|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.71|=0.449
71744959|NCT03827655|143001184|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.507|TWO_SIDED|90.0|0.69|1.44||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.44|0.69|=0.507
71744960|NCT03827655|143001185|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.406|TWO_SIDED|90.0|0.73|1.52||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.52|0.73|=0.406
71744961|NCT03827655|143001185|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.88|TWO_SIDED|90.0|0.54|1.11||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.11|0.54|=0.880
71744962|NCT03827655|143001186|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.446|TWO_SIDED|90.0|0.72|1.48||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.48|0.72|=0.446
71778098|NCT02713204|143055458|SUPERIORITY||Least square mean difference|0.24||||0.7027|TWO_SIDED|95.0|-0.99|1.46||Threshold for significance at 0.05 level.|ANCOVA|||||1.46|-0.99|0.7027
71778099|NCT02713204|143055459|SUPERIORITY||Least square mean difference|-0.6||||0.4927|TWO_SIDED|95.0|-2.34|1.13||Threshold for significance at 0.05 level.|ANCOVA|||||1.13|-2.34|0.4927
71778100|NCT02713204|143055459|SUPERIORITY||Least square mean difference|0.38||||0.6645|TWO_SIDED|95.0|-1.36|2.13||Threshold for significance at 0.05 level.|ANCOVA|||||2.13|-1.36|0.6645
71778101|NCT02713204|143055459|SUPERIORITY||Least square mean difference|-0.89||||0.3091|TWO_SIDED|95.0|-2.61|0.83||Threshold for significance at 0.05 level.|ANCOVA|||||0.83|-2.61|0.3091
71778102|NCT02713204|143055459|SUPERIORITY||Least square mean difference|-0.6||||0.4898|TWO_SIDED|95.0|-2.29|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-2.29|0.4898
71778103|NCT02713204|143055459|SUPERIORITY||Least square mean difference|-0.8||||0.3504|TWO_SIDED|95.0|-2.5|0.89||Threshold for significance at 0.05 level.|ANCOVA|||||0.89|-2.50|0.3504
71778104|NCT02713204|143055459|SUPERIORITY||Least square mean difference|-0.98||||0.2632|TWO_SIDED|95.0|-2.7|0.74||Threshold for significance at 0.05 level.|ANCOVA|||||0.74|-2.70|0.2632
71778105|NCT02713204|143055459|SUPERIORITY||Least square mean difference|0.21||||0.8056|TWO_SIDED|95.0|-1.46|1.88||Threshold for significance at 0.05 level.|ANCOVA|||||1.88|-1.46|0.8056
71834552|NCT05478525|143173238|SUPERIORITY||LS Mean Difference|-155.68||||0.0298|TWO_SIDED|95.0|-295.35|-16.01|||ANCOVA|||Analysis at Day 14||-16.01|-295.35|0.0298
71744963|NCT03827655|143001186|SUPERIORITY||Hazard Ratio (HR)|0.76|||=|0.892|TWO_SIDED|90.0|0.53|1.09||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.09|0.53|=0.892
71744964|NCT03827655|143001187|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.76|TWO_SIDED|90.0|0.6|1.23||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.23|0.60|=0.760
71744965|NCT03827655|143001187|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.81|TWO_SIDED|90.0|0.58|1.18||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-squared test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.18|0.58|=0.810
71744966|NCT03827655|143001188|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.288|TWO_SIDED|90.0|0.78|1.64||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.64|0.78|=0.288
71744967|NCT03827655|143001188|SUPERIORITY||Hazard Ratio (HR)|1.03|||=|0.453|TWO_SIDED|90.0|0.72|1.47||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.47|0.72|=0.453
71778106|NCT02713204|143055460|SUPERIORITY||Least square mean difference|0.57||||0.5065|TWO_SIDED|95.0|-1.11|2.25||Threshold for significance at 0.05 level.|ANCOVA|||||2.25|-1.11|0.5065
71778107|NCT02713204|143055460|SUPERIORITY||Least square mean difference|-0.22||||0.7418|TWO_SIDED|95.0|-1.55|1.1||Threshold for significance at 0.05 level.|ANCOVA|||||1.10|-1.55|0.7418
71778108|NCT02713204|143055461|SUPERIORITY||Least square mean difference|-0.19||||0.8383|TWO_SIDED|95.0|-1.99|1.62||Threshold for significance at 0.05 level.|ANCOVA|||||1.62|-1.99|0.8383
71778109|NCT02713204|143055461|SUPERIORITY||Least square mean difference|-0.1||||0.918|TWO_SIDED|95.0|-1.91|1.72||Threshold for significance at 0.05 level.|ANCOVA|||||1.72|-1.91|0.9180
71778110|NCT02713204|143055461|SUPERIORITY||Least square mean difference|-1.41||||0.1238|TWO_SIDED|95.0|-3.2|0.39||Threshold for significance at 0.05 level.|ANCOVA|||||0.39|-3.20|0.1238
71778111|NCT02713204|143055461|SUPERIORITY||Least square mean difference|-0.97||||0.2819|TWO_SIDED|95.0|-2.73|0.8||Threshold for significance at 0.05 level.|ANCOVA|||||0.80|-2.73|0.2819
71665151|NCT05013008|142844111|OTHER|The hypotheses 'H0i: βi=0' (i=1,…,27) were tested at a two-sided significance level of 5%, where βi was the estimator for the difference in log-transformed ratios of biomarker levels of Visit 11 to Visit 3 between finerenone and placebo group for the i-th of the 27 pre-specified biomarkers.|||||=|0.979||||||Benjamini-Hochberg adjusted P-value was calculated using the log2-scaled NPX value.|t-test, 2 sided|||The NPX difference (corresponding to log-transformed ratio to baseline) of Dickkopf-related protein 3 (Q9UBP4) was analyzed.||||= 0.979
71665152|NCT02207634|142844151|NON_INFERIORITY|The non-inferiority margin was 0.19, calculated as 20% of the observed common standard deviation, which was estimated from observations in the placebo group by a repeated measured mixed-effect linear model with visit as a covariate. If the upper bound of the 95% CI for the difference between the placebo and evolocumab group in mean change from baseline for Z score averaged across the visits was less than the non-inferiority margin non-inferiority criteria were met.|Treatment Difference|0.0072|STANDARD_ERROR_OF_MEAN|0.0375|||TWO_SIDED|95.0|-0.0664|0.0808||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening low-density lipoprotein cholesterol \[LDL-C\] and geographical region), age, education level, baseline SWM strategy index Z score, treatment group, visit, and treatment by visit interaction.||0.0808|-0.0664|
71665153|NCT02207634|142844152|OTHER||Treatment Difference|0.0333|STANDARD_ERROR_OF_MEAN|0.0363|||TWO_SIDED|95.0|-0.0378|0.1045||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline SWM between-errors Z score, treatment group, visit, and treatment by visit interaction.||0.1045|-0.0378|
71665154|NCT02207634|142844153|OTHER||Treatment Difference|0.0226|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.0422|0.0873||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline PAL total errors adjusted Z score, treatment group, visit, and treatment by visit interaction.||0.0873|-0.0422|
71665155|NCT02207634|142844154|OTHER||Treatment Difference|0.0727|STANDARD_ERROR_OF_MEAN|0.0382|||TWO_SIDED|95.0|-0.0022|0.1477||||||A repeated measures mixed-effect linear model was used to estimate treatment difference ( placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline RTI median 5-choice reaction time Z score, treatment group, visit, and treatment by visit interaction.||0.1477|-0.0022|
71665156|NCT00591773|142844165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.86|||<|0.001|TWO_SIDED|95.0|-18.54|-13.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-13.19|-18.54|<0.001
71665157|NCT00591773|142844165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-18.13|-12.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-12.76|-18.13|<0.001
71778112|NCT02713204|143055461|SUPERIORITY||Least square mean difference|-1.02||||0.2581|TWO_SIDED|95.0|-2.78|0.75||Threshold for significance at 0.05 level.|ANCOVA|||||0.75|-2.78|0.2581
71778113|NCT02713204|143055461|SUPERIORITY||Least square mean difference|-0.87||||0.339|TWO_SIDED|95.0|-2.66|0.92||Threshold for significance at 0.05 level.|ANCOVA|||||0.92|-2.66|0.3390
71778114|NCT02713204|143055461|SUPERIORITY||Least square mean difference|0.05||||0.9558|TWO_SIDED|95.0|-1.69|1.79||Threshold for significance at 0.05 level.|ANCOVA|||||1.79|-1.69|0.9558
71778115|NCT03488355|143055484|SUPERIORITY||Risk Ratio (RR)|1.15||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
71778116|NCT01254630|143055615|SUPERIORITY||Vaccine Efficacy|0.636|||||TWO_SIDED|97.5|0.364|0.791|||||Point estimate and 97.5% CI of vaccine efficacy (primary endpoint) were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 97.5% Confidence Interval (CI) be \>0.25.||0.791|0.364|
71778117|NCT01254630|143055616|OTHER||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-1.8|4.5||||||||4.5|-1.8|
71778118|NCT01254630|143055617|OTHER||Vaccine Efficacy|0.771|||||TWO_SIDED|95.0|0.48|0.899|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.899|0.480|
71778119|NCT01254630|143055618|OTHER||Vaccine Efficacy|0.874|||||TWO_SIDED|95.0|-0.005|0.984|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.984|-0.005|
71778120|NCT01254630|143055619|OTHER||Vaccine Efficacy|0.746|||||TWO_SIDED|95.0|-1.275|0.972|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be \>0.25.||0.972|-1.275|
71778121|NCT01254630|143055620|OTHER||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||||1.6|-0.6|
71778122|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.24|1.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.80|1.24|
71665158|NCT00591773|142844166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|||<|0.001|TWO_SIDED|95.0|-17.81|-10.99||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-10.99|-17.81|<0.001
71665159|NCT00591773|142844166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-16.1|-9.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-9.25|-16.10|<0.001
71665160|NCT00591773|142844167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.29|||<|0.001|TWO_SIDED|95.0|-12.02|-8.56||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.56|-12.02|<0.001
71665161|NCT00591773|142844167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|||<|0.001|TWO_SIDED|95.0|-12.23|-8.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.76|-12.23|<0.001
71665162|NCT00591773|142844168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.25|-5.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.25|-9.25|<0.001
71665163|NCT00591773|142844168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-9.06|-5.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.05|-9.06|<0.001
71665164|NCT00591773|142844169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-19.56|-14.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.04|-19.56|<0.001
71665165|NCT00591773|142844169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.24|||<|0.001|TWO_SIDED|95.0|-19.01|-13.47||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.47|-19.01|<0.001
71665166|NCT00591773|142844170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02|||<|0.001|TWO_SIDED|95.0|-12.86|-9.18||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.18|-12.86|<0.001
71665167|NCT00591773|142844170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.04|-9.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.35|-13.04|<0.001
71665168|NCT00591773|142844171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.93|||<|0.001|TWO_SIDED|95.0|-15.92|-9.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.94|-15.92|<0.001
71665169|NCT00591773|142844171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.83|-9.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.84|-15.83|<0.001
71665170|NCT00591773|142844172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-10.14|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.14|<0.001
71778123|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.15||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.15|0.78|
71778124|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.12||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.12|0.80|
71778125|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.19|1.76||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.76|1.19|
71778126|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.86|0.59|
71778127|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|1.15|1.86||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.86|1.15|
71778128|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.97|1.42||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.42|0.97|
71665171|NCT00591773|142844172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|||<|0.001|TWO_SIDED|95.0|-10.15|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.19|-10.15|<0.001
71665172|NCT00591773|142844173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.52|||<|0.001|TWO_SIDED|95.0|-20.39|-14.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.64|-20.39|<0.001
71665173|NCT00591773|142844173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.001|TWO_SIDED|95.0|-19.84|-14.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-14.05|-19.84|<0.001
71665174|NCT00591773|142844174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54|||<|0.001|TWO_SIDED|95.0|-13.49|-9.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.59|-13.49|<0.001
71665175|NCT00591773|142844174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.68|||<|0.001|TWO_SIDED|95.0|-13.64|-9.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.72|-13.64|<0.001
71665176|NCT00591773|142844175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.04|||<|0.001|TWO_SIDED|95.0|-17.13|-10.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.94|-17.13|<0.001
71665177|NCT00591773|142844175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.48|||<|0.001|TWO_SIDED|95.0|-16.58|-10.37||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.37|-16.58|<0.001
71778129|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.36|2.13||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||2.13|1.36|
71665178|NCT00591773|142844176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.42|||<|0.001|TWO_SIDED|95.0|-11.65|-7.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-11.65|<0.001
71665179|NCT00591773|142844176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69|||<|0.001|TWO_SIDED|95.0|-11.92|-7.46||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.46|-11.92|<0.001
71665180|NCT00591773|142844177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.38|7.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.03|2.38|<0.001
71665181|NCT00591773|142844177|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.82|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.03|1.82|<0.001
71665182|NCT00591773|142844178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|1.9|7.27||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.27|1.90|<0.001
71665183|NCT00591773|142844178|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.002|TWO_SIDED|95.0|1.46|5.0||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.00|1.46|0.002
71665184|NCT00591773|142844179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|2.41|6.64||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.64|2.41|<0.001
71665185|NCT00591773|142844179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.79||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.79|1.83|<0.001
71665186|NCT00459355|142844180|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<0.0001
71834553|NCT05478525|143173238|SUPERIORITY||LS Mean Difference|-143.74||||0.0433|TWO_SIDED|95.0|-282.92|-4.55|||ANCOVA|||Analysis at Day 14||-4.55|-282.92|0.0433
71834554|NCT05478525|143173238|SUPERIORITY||LS Mean Difference|-178.33||||0.0201|TWO_SIDED|95.0|-327.16|-29.5|||ANCOVA|||Analysis at Day 14||-29.50|-327.16|0.0201
71834555|NCT05478525|143173239|SUPERIORITY||LS Mean Difference|-47.07||||0.1992|TWO_SIDED|95.0|-119.94|25.81|||ANCOVA|||Analysis at Day 14||25.81|-119.94|0.1992
71834556|NCT05478525|143173239|SUPERIORITY||LS Mean Difference|-70.32||||0.0617|TWO_SIDED|95.0|-144.26|3.61|||ANCOVA|||Analysis at Day 14||3.61|-144.26|0.0617
71834557|NCT05478525|143173239|SUPERIORITY||LS Mean Difference|-39.84||||0.2981|TWO_SIDED|95.0|-116.22|36.53|||ANCOVA|||Analysis at Day 14||36.53|-116.22|0.2981
71665187|NCT00459355|142844181|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||MANCOVA|||||||<.0001
71665188|NCT00459355|142844182|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||MANCOVA|||||||.002
71665189|NCT02135614|142844183|SUPERIORITY||Treatment difference|0.12||||0.46|TWO_SIDED|95.0|-0.2|0.43||P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates.|ANCOVA|||||0.43|-0.20|0.46
71665190|NCT02135614|142844184|SUPERIORITY||Treatment difference|0.08||||0.046|TWO_SIDED|95.0|0.0|0.16||P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates.|ANCOVA|||||0.16|0.00|0.046
71665191|NCT02135614|142844185|SUPERIORITY|||||||0.39||||||P-value was calculated from the negative binomial model with the stratification factor as covariate.|Negative Binomial Model|||||||0.39
71665192|NCT02135614|142844186|SUPERIORITY|||||||0.004||||||P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor.|Negative Binomial Model|||||||0.004
71665193|NCT04315506|142844221|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5384|TWO_SIDED|95.0|0.75|1.72||The analysis was a two-intervention arm comparison. Adjustments for multiple tests and outcomes were not required.|Regression, Logistic||Odds of quitting in Enuf Snuff group (SGR) compared to Enough Snuff (control)|||1.72|0.75|0.5384
71665194|NCT04315506|142844222|SUPERIORITY||Slope|-0.1057||||0.6624|TWO_SIDED|95.0|-0.5808|0.3693||P-value above is for the treatment-by-time squared term in the statistical model for longitudinal data; quadratic change in outcome determined, compared trajectory of outcome change in EnufSnuff (SGR) compared to Enough Snuff (control)|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted.|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.3693|-0.5808|0.6624
71665195|NCT04315506|142844223|SUPERIORITY||Slope|0.0946||||0.232|TWO_SIDED|95.0|-0.0609|0.2501||A multi-level, mixed-effects model for longitudinal data was applied. The p-value provided above was for the treatment-by-time effect used to test for differences in the trajectory of change in craving reduction between the two treatment groups.|Mixed Models Analysis|Multi-level, mixed-effects model for longitudinal data was conducted. (trajectory analysis)|Slope difference estimate reported above, estimate compares trajectory slope coefficient for EnufSnuff (SGR) to slope coefficient for Enough Snuff (control).|For secondary outcomes, the study was not powered. The null hypothesis was no between-treatment arm difference in the trajectory of change from baseline to six months.||0.2501|-0.0609|0.2320
71665196|NCT03593395|142844225|OTHER|Estimation only|Least Square Mean Estimate|2.46|||||TWO_SIDED|95.0|1.81|3.34|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||3.34|1.81|
71665197|NCT03593395|142844225|OTHER|Estimation only.|Least Square Mean Estimate|2.96|||||TWO_SIDED|95.0|2.09|4.19|||||Estimates are from generalized linear mixed model with a negative binomial distribution log link construct and length of follow up offset. Includes fixed effects for site size, baseline acute utilization, and random effect for cluster (site).|||4.19|2.09|
71665198|NCT02995408|142844240|SUPERIORITY||Mean Difference (Final Values)|-0.99||||0.23|TWO_SIDED|95.0|-2.63|0.65||p-value was calculated|t-test, 2 sided|||||0.65|-2.63|.23
71665199|NCT02995408|142844241|SUPERIORITY||Mean Difference (Final Values)|5.78||||0.024|TWO_SIDED|95.0|0.78|10.78||.05 is the threshold for significance|t-test, 2 sided|||We examined between group (3RP treatment versus wait-list) differences in pre-post change scores of resiliency.||10.78|.78|0.024
71665200|NCT02995408|142844242|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.001|TWO_SIDED|95.0|3.45|12.12||p=.05 is the threshold for significance.|t-test, 2 sided|||||12.12|3.45|0.001
71665201|NCT00101283|142844363|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|18.8|||||TWO_SIDED|90.0|5.4|41.7|||||Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||41.7|5.4|
71744968|NCT03827655|143001189|SUPERIORITY||Risk Difference (RD)|-0.09|||=|0.046|TWO_SIDED|90.0|-0.17|0.0||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.00|-0.17|=0.046
71744969|NCT03827655|143001189|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.516|TWO_SIDED|90.0|-0.11|0.11||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.11|-0.11|=0.516
71744970|NCT03827655|143001190|SUPERIORITY||Risk Difference (RD)|-0.03|||=|0.296|TWO_SIDED|90.0|-0.12|0.06||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.06|-0.12|=0.296
71744971|NCT03827655|143001190|SUPERIORITY||Risk Difference (RD)|0.03|||=|0.677|TWO_SIDED|90.0|-0.07|0.13||P-value was derived using a one-sided test with Ha: Risk Difference\<0.|Stratified Miettinen and Nurminen||The p-values, risk differences and corresponding 90% CIs were obtained using a stratified Miettinen and Nurminen approach with strata weighting by sample size.|||0.13|-0.07|=0.677
71744972|NCT03827655|143001191|SUPERIORITY||Hazard Ratio (HR)|1.1|||=|0.338|TWO_SIDED|90.0|0.76|1.57||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.57|0.76|=0.338
71778130|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.48|0.67||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.67|0.48|
71778131|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.53|0.89||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.89|0.53|
71778132|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|1.05|1.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.67|1.05|
71778133|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||TWO_SIDED|95.0|0.53|0.76||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||0.76|0.53|
71778134|NCT00761631|143055636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.91|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 - 13vPnC Group 3).||1.28|0.91|
71778135|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0007
71778136|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||0.0007
71778137|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||0.0011
71778138|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0015|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||0.0015
71778139|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0029|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0029
71778140|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||0.0004
71778141|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0059|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||0.0059
71778142|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||0.0002
71778143|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||0.0002
71778144|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
71778145|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
71778146|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
71778147|NCT01313858|143055670|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||0.0002
71778148|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
71778149|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
71778150|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
71778151|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)||||<0.0001
71778152|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)||||<0.0001
71778153|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)||||<0.0001
71778154|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)||||<0.0001
71778155|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)||||<0.0001
71778156|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)||||<0.0001
71778157|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)||||<0.0001
71778158|NCT01313858|143055670|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)||||<0.0001
71778159|NCT01313858|143055671|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||0.0003
71778160|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
71778161|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
71778162|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
71778163|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
71665202|NCT00101283|142844363|SUPERIORITY_OR_OTHER_LEGACY||Overall Response Percent|0.0|||||TWO_SIDED|90.0|0.0|20.6|||||Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.||20.6|0.0|
71778164|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
71778165|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
71665203|NCT00606632|142844379|SUPERIORITY|||||||0.023|||||||McNemar|||||||0.023
71665204|NCT00606632|142844379|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
71778166|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
71778167|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
71778168|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
71778169|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)||||<0.0001
71665205|NCT05084924|142844383|SUPERIORITY|||||||0.049|||||||ANOVA|Main effect of stimulation: F(2,32) = 3.32||||||0.049
71665206|NCT05084924|142844384|SUPERIORITY|||||||0.004||||||Main effect of stimulation: F(2,32) = 6.67|ANOVA|||||||0.004
71778170|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)||||<0.0001
71778171|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)||||<0.0001
71778172|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)||||<0.0001
71778173|NCT01313858|143055671|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)||||<0.0001
71778174|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
71778175|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
71665207|NCT00704132|142844385|SUPERIORITY_OR_OTHER||Difference in Least-Squares Mean|-111.0|||<|0.001||95.0|-158.0|-63.9|||ANCOVA||Sitagliptin minus Placebo|||-63.9|-158.0|<0.001
71665208|NCT03633825|142844397|SUPERIORITY||Risk Ratio (RR)|1.23|||=|0.02|TWO_SIDED|95.0|1.03|1.46|||Chi-squared|||||1.46|1.03|=.02
71665209|NCT03633825|142844398|SUPERIORITY||Risk Ratio (RR)|1.2|||=|0.19|TWO_SIDED|95.0|0.91|1.59|||Chi-squared|||||1.59|0.91|=.19
71665210|NCT03277066|142844399|SUPERIORITY||Lest-Squared Mean Differences|0.011||||0.011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0110
71665211|NCT03277066|142844399|SUPERIORITY||Lest-Squared Mean Differences|0.2835||||0.2835|TWO_SIDED||||||Mixed Models Analysis|||||||0.2835
71665212|NCT03774407|142844409|OTHER|||||||0.002||||||This P value reported was for bladder urinary frequency change from baseline to 9 months|p value|||||||0.002
71665213|NCT04841577|142844412|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for RSVPreF3 OA investigational vaccine is ≤ (equal to or smaller than) 1.5.|Adjusted group GMT ratio|1.27|||||TWO_SIDED|95.0|1.12|1.44||||||Adjusted ratios of Control group over Co-Ad Group in RSV-A Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-A neutralizing antibodies The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.44|1.12|
71778176|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
71778177|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
71778178|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
71778179|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
71778180|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
71778181|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
71778182|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)||||<0.0001
71778183|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)||||<0.0001
71778184|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)||||<0.0001
71778185|NCT01313858|143055672|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)||||<0.0001
71778186|NCT01935791|143055675|OTHER||||||<|0.01||||||The p-values were adjusted for multiple comparisons. The a priori threshold for statistical significance is p\<0.05.|ANOVA|plus Tukey test||||||<0.01
71778187|NCT01935791|143055676|OTHER||||||<|0.001|||||||ANOVA|plus Tukey test||||||<0.001
71665214|NCT04841577|142844413|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean titer ratio|1.17|||||TWO_SIDED|95.0|1.02|1.35||||||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.35|1.02|
71665215|NCT04841577|142844413|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44||||||For the Flu A/Victoria/2570/2019 (H1N1) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.44|1.03|
71665216|NCT04841577|142844413|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.17|||||TWO_SIDED|95.0|1.04|1.32||||||For the Flu B/Phuket/3073/2013 (Yamagata) strain, an ANCOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.32|1.04|
71665217|NCT04841577|142844413|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the group GMT ratio \[Control group divided by Co Ad group\] for each of the FLU vaccine strains is ≤1.5.|Adjusted geometric mean Titer ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26||||||For the Flu B/Washington/02/2019 (Victoria) strain, an ANOVA model was used to analyze post-vaccination log-transformed titers. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 transformed titer as covariate.||1.26|0.95|
71665218|NCT04841577|142844414|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|2.6|||||TWO_SIDED|95.0|-4.13|9.3|||Miettinen and Nurminen|||For the Flu A/Hong Kong/2671/2019 (H3N2) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.30|-4.13|
71744973|NCT03827655|143001191|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.422|TWO_SIDED|90.0|0.73|1.49||P-values were derived using a one-sided test with alternative hypothesis (Ha): Hazard Ratio\>1.|Wald chi-square test||Hazard ratios, 90% CIs and associated Wald Chi-square p-values between TAK-954 dose levels and placebo are obtained using a stratified Cox proportional hazard model with treatment as the only independent variable.|||1.49|0.73|=0.422
71744974|NCT01721161|143001197|SUPERIORITY_OR_OTHER||Difference|-3.48||||0.3337|TWO_SIDED|95.0|-10.61|3.65|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||3.65|-10.61|0.3337
71744975|NCT01721161|143001198|SUPERIORITY_OR_OTHER||Difference|-3.89||||0.1868|TWO_SIDED|95.0|-9.7|1.92|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||1.92|-9.70|0.1868
71744976|NCT01721161|143001199|SUPERIORITY_OR_OTHER||Difference|-4.76||||0.1488|TWO_SIDED|95.0|-11.26|1.74|||ANCOVA|||||1.74|-11.26|0.1488
71744977|NCT01721161|143001200|SUPERIORITY_OR_OTHER||Difference|-1.15||||0.4975|TWO_SIDED|95.0|-4.51|2.21|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|||2.21|-4.51|0.4975
71778188|NCT02476201|143055705|SUPERIORITY|Using a one-sided, one sample Exact Binomial Test and a significance level of 2.5%, the study required 74 patients to reach a power of 90%. With the MPP feature activated at baseline, it was assumed that the proportion of responders at 6 months was 75%. The MPP responder rate was compared to 57%, which is the responder rate obtained from literature for patients without the MPP feature activated.|Percentage|67.1||||0.0435|ONE_SIDED|97.5|55.6||||Exact binomial||||||55.6|0.0435
71744978|NCT01721161|143001201|SUPERIORITY_OR_OTHER||Difference|-1.76||||0.3505|TWO_SIDED|95.0|-5.5|1.98|||ANCOVA|||||1.98|-5.50|0.3505
71744979|NCT01721161|143001202|SUPERIORITY_OR_OTHER||Difference|-1.6||||0.5371|TWO_SIDED|95.0|-6.9|3.6|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 1.25% chart||3.6|-6.9|0.5371
71744980|NCT01721161|143001202|SUPERIORITY_OR_OTHER||Difference|-0.8||||0.7741|TWO_SIDED|95.0|-6.5|4.9|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 2.5% chart||4.9|-6.5|0.7741
71744981|NCT01721161|143001203|SUPERIORITY_OR_OTHER||Difference|-1.2||||0.6645|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|||LCLA 1.25% chart||4.3|-6.6|0.6645
71744982|NCT01721161|143001203|SUPERIORITY_OR_OTHER||DIfference|-0.8||||0.8015|TWO_SIDED|95.0|-6.7|5.2|||ANCOVA|||LCLA 2.5%||5.2|-6.7|0.8015
71744983|NCT01721161|143001204|SUPERIORITY_OR_OTHER||Difference|-7.55||||0.0504|TWO_SIDED|95.0|-15.12|0.01|||ANCOVA|||||0.01|-15.12|0.0504
71744984|NCT01216202|143001207|SUPERIORITY|||||||0.014||||||The threshold for statistical significance was p = 0.05.|Regression, Linear|||The association between change in serum testosterone levels and cumulative mean testicular radiation dose was assessed using longitudinal regression analysis (GEE). No preoperative RT contributed with baseline values.||||0.014
71744985|NCT01216202|143001208|SUPERIORITY||Estimated mean change|-4.0||||0.008|TWO_SIDED|95.0|-6.9|-1.0||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for time between preoperative radiotherapy (RT) and surgery.||The association between change in total number of sperms per ejaculate and relative mean testicular dose was assessed using longitudinal regression analysis (GEE).||-1.0|-6.9|0.008
71744986|NCT03483896|143001230|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71744987|NCT03483896|143001231|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
71744988|NCT02888106|143001233|SUPERIORITY|||||||0.0022|||||||Fisher Exact|||The proportions of negative HDV RNA response at week 72 in each of the MXB treatment groups were compared with the control group of PEG-IFNα by using Fisher's exact test and by presenting exact unconditional 95%-confidence intervals (CI) based on scores for the proportion differences.||||0.0022
71744989|NCT02888106|143001233|SUPERIORITY|||||||0.0996|||||||Fisher Exact|||||||0.0996
71744990|NCT02888106|143001233|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71778189|NCT00398918|143055715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.4|<|0.05||95.0|||||Mixed Models Analysis|Results presented are for post-hoc comparisons of least squares means with Tukey-Kramer adjucted p values.|The estimated value is for the difference between the means obtained for the second hour of the self-administration sessions for the placebo and zonisamide conditions.|The analysis involved a within subjects comparison. The null hypothesis was that there would be no difference in the amount of ethanol consumed in either the first or second hour of self-administration sessions. Results presented here are for the second hour of the self-administration sessions.||||<0.05
71778190|NCT00398918|143055716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.61||95.0||||P value shown is for a post-hoc comparison of least squares means generated by the mixed model used.|Mixed Models Analysis||Analysis for difference between DSMT scores at 40 minutes post alcohol ingestion for zonisamide and placebo involved post-hoc comparisons of least squares means.|Null hypothesis: No difference in DSMT scores for zonisamide and placebo treatments 40 minutes after ingestion of ethanol.||||0.61
71778191|NCT03840174|143055732|OTHER||GMT Ratio|77.7|||||TWO_SIDED|95.0|23.9|252.4|||||Geometric Mean Titer (GMT) ratio and 95% CI were estimated using an ANOVA model.|||252.4|23.9|
71778192|NCT00131508|143055745|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.||||0.17
71665219|NCT04841577|142844414|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.53|||||TWO_SIDED|95.0|-0.77|9.83|||Miettinen and Nurminen|||For the Flu A/Victoria/2570/2019 (H1N1) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||9.83|-0.77|
71778193|NCT00131508|143055746|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.||||0.53
71665220|NCT04841577|142844414|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|4.04|||||TWO_SIDED|95.0|-2.21|10.28|||Miettinen and Nurminen|||For the Flu B/Phuket/3073/2013 (Yamagata) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||10.28|-2.21|
71665221|NCT04841577|142844414|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in seroconversion rate is ≤10% for HI antibody titers.|Difference in percentage|0.41|||||TWO_SIDED|95.0|-6.07|6.9|||Miettinen and Nurminen|||For the Flu B/Washington/02/2019 (Victoria) strain, the 2-sided 95% CI on group difference in seroconversion rate (Control group minus Co-Ad group).||6.90|-6.07|
71665222|NCT04841577|142844416|OTHER||Adjusted group GMT ratio|1.28|||||TWO_SIDED|95.0|1.09|1.51||||||Adjusted ratios of Control group over Co-Ad Group in RSV-B Neutralizing antibody GMTs at one month after RSV\_PreF3 OA investigational vaccination. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed titers of RSV-B neutralizing antibodies. The ANCOVA model included the treatment group, the age category (age at vaccination: 60-69, 70-79 or \>=80 years), country and sex as fixed effects and the pre-dose log-10 titer as covariate.||1.51|1.09|
71665223|NCT00182325|142844426|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71665224|NCT00182325|142844427|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71665225|NCT00182325|142844428|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71665226|NCT00182325|142844429|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71665227|NCT00182325|142844430|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71744991|NCT02888106|143001233|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71744992|NCT02888106|143001233|SUPERIORITY|||||||0.0421|||||||Fisher Exact|||||||0.0421
71744993|NCT02888106|143001234|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
71744994|NCT02888106|143001234|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||Week 24||||0.0052
71778194|NCT00131508|143055747|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.||||0.24
71665228|NCT00182325|142844431|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71665229|NCT00182325|142844432|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71665230|NCT00182325|142844433|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71665231|NCT00182325|142844434|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
71665232|NCT00182325|142844435|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||0.12
71665233|NCT01890434|142844444|SUPERIORITY||Sensitivity Difference|16.7||||9e-05|ONE_SIDED|95.0|9.3||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||9.3|0.00009
71665234|NCT01890434|142844444|SUPERIORITY||Sensitivity Difference|26.0|||<|0.0001|ONE_SIDED|95.0|18.2||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||18.2|<0.0001
71744995|NCT02888106|143001234|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71744996|NCT02888106|143001234|SUPERIORITY|||||||0.0017|||||||Fisher Exact|||Week 24||||0.0017
71744997|NCT02888106|143001234|SUPERIORITY|||||||0.3295|||||||Fisher Exact|||Week 24||||0.3295
71744998|NCT02888106|143001234|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
71744999|NCT02888106|143001234|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Week 48||||0.0001
71745000|NCT02888106|143001234|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71745001|NCT02888106|143001234|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 48||||0.0007
71745002|NCT02888106|143001234|SUPERIORITY|||||||0.1086|||||||Fisher Exact|||Week 48||||0.1086
71745003|NCT02888106|143001235|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71745004|NCT02888106|143001235|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
71745005|NCT02888106|143001235|SUPERIORITY|||||||0.0002|||||||Fisher Exact|||Week 24||||0.0002
71745006|NCT02888106|143001235|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
71745007|NCT02888106|143001235|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||Week 24||||0.0007
71745008|NCT02888106|143001235|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71745009|NCT02888106|143001235|SUPERIORITY|||||||0.4497|||||||Fisher Exact|||Week 48||||0.4497
71745010|NCT02888106|143001235|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
71745011|NCT02888106|143001235|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71745012|NCT02888106|143001235|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
71745013|NCT02888106|143001235|SUPERIORITY|||||||0.0743|||||||Fisher Exact|||Week 72||||0.0743
71745014|NCT02888106|143001235|SUPERIORITY|||||||0.3449|||||||t-test, 1 sided|||Week 72||||0.3449
71745015|NCT02888106|143001235|SUPERIORITY|||||||0.6036|||||||Fisher Exact|||Week 72||||0.6036
71745016|NCT02888106|143001235|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
71745017|NCT02888106|143001235|SUPERIORITY|||||||0.3408|||||||Fisher Exact|||Week 72||||0.3408
71745018|NCT02888106|143001236|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71745019|NCT02888106|143001236|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 24||||0.2241
71745020|NCT02888106|143001236|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
71745021|NCT02888106|143001236|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
71745022|NCT02888106|143001236|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 24||||0.4828
71745023|NCT02888106|143001236|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
71665235|NCT01890434|142844444|SUPERIORITY||Sensitivity Difference|32.0|||<|0.0001|ONE_SIDED|95.0|24.5||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||24.5|<0.0001
71665236|NCT01890434|142844445|SUPERIORITY||Sensitivity Difference|21.0||||5e-05|ONE_SIDED|95.0|12.1||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|||12.1|0.00005
71665237|NCT01890434|142844445|SUPERIORITY||Sensitivity Difference|36.2|||<|0.0001|ONE_SIDED|95.0|26.3||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|||26.3|<0.0001
71665238|NCT01890434|142844445|SUPERIORITY||Sensitivity Difference|41.0|||<|0.0001|ONE_SIDED|95.0|31.8||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|||31.8|<0.0001
71665239|NCT01890434|142844450|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|95.0|12.9|28.4|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.||28.4|12.9|<0.0001
71665240|NCT01890434|142844450|SUPERIORITY||Sensitivity Difference|21.3|||<|0.0001|TWO_SIDED|90.0|14.2|27.2|||McNemar|McNemar 2-sided test at alpha level of 10%||||27.2|14.2|<0.0001
71745024|NCT02888106|143001236|SUPERIORITY|||||||0.1686|||||||Fisher Exact|||Week 48||||0.1686
71745025|NCT02888106|143001236|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71778195|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.||||0.62
71778196|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.||||0.14
71778197|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.||||0.20
71778198|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.||||0.62
71778199|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.||||0.61
71665241|NCT01890434|142844452|NON_INFERIORITY|A non-inferiority margin was set as 15%|Sensitivity Difference|5.7||||0.2733|TWO_SIDED|95.0|-5.4|14.9|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.||14.9|-5.4|0.2733
71665242|NCT01890434|142844452|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Sensitivity Difference|0.0||||1|TWO_SIDED|95.0|-8.6|7.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.||7.2|-8.6|1.0000
71665243|NCT01890434|142844454|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|11.1||||0.001|TWO_SIDED|95.0|4.1|17.0|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.||17.0|4.1|0.0010
71665244|NCT01890434|142844454|NON_INFERIORITY|A non-inferiority margin was set as 15%.|Specificity Difference|7.8||||0.0094|TWO_SIDED|95.0|1.6|13.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.||13.2|1.6|0.0094
71665245|NCT02027428|142844558|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.3486|TWO_SIDED|95.0|0.61|1.19||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.19|0.61|0.3486
71745026|NCT02888106|143001236|SUPERIORITY|||||||0.5977|||||||Fisher Exact|||Week 48||||0.5977
71745027|NCT02888106|143001236|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71745028|NCT02888106|143001236|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 72||||0.0063
71745029|NCT02888106|143001236|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71745030|NCT02888106|143001236|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71745031|NCT02888106|143001236|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71745032|NCT02888106|143001236|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71745033|NCT02888106|143001237|SUPERIORITY|||||||0.0801|||||||Fisher Exact|||Week 24||||0.0801
71745034|NCT02888106|143001237|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71745035|NCT02888106|143001237|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71745036|NCT02888106|143001237|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71745037|NCT02888106|143001237|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71745038|NCT02888106|143001237|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||Week 48||||0.0063
71745039|NCT02888106|143001237|SUPERIORITY|||||||0.2241|||||||Fisher Exact|||Week 48||||0.2241
71745040|NCT02888106|143001237|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71745041|NCT02888106|143001237|SUPERIORITY|||||||0.0169|||||||Regression, Cox|||Week 72||||0.0169
71745042|NCT02888106|143001237|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71778200|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.||||0.65
71665246|NCT02027428|142844559|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0365|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0365
71778201|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.||||0.55
71778202|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.||||0.69
71778203|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.||||0.82
71778204|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.||||0.99
71778205|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.||||0.30
71778206|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.||||0.24
71778207|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.||||0.50
71778208|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.||||0.45
71665247|NCT02027428|142844560|SUPERIORITY||Overall response rate ratio|1.2||||0.087|TWO_SIDED|95.0|0.948|1.519||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|Cochran-Mantel-Haenszel||response ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. The rate ratio and its 95% CI were based on the non-stratified analysis.||1.519|0.948|0.0870
71778209|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.||||0.46
71745043|NCT02888106|143001237|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 72||||0.4828
71745044|NCT02888106|143001238|SUPERIORITY|||||||0.4828|||||||Fisher Exact|||Week 48||||0.4828
71745045|NCT02888106|143001238|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71778210|NCT00131508|143055748|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.||||0.84
71778211|NCT00131508|143055749|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.20
71778212|NCT00131508|143055749|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.81
71778213|NCT00131508|143055749|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.||||0.70
71745046|NCT02888106|143001238|SUPERIORITY|||||||0.2292|||||||Fisher Exact|||Week 72||||0.2292
71745047|NCT02888106|143001238|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71745048|NCT02888106|143001239|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
71745049|NCT02888106|143001239|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||Week 24||||1.0000
71745050|NCT02888106|143001239|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 24||||1.0000
71778214|NCT00131508|143055750|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.69
71778215|NCT00131508|143055750|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.75
71745051|NCT02888106|143001239|SUPERIORITY|||||||0.4621|||||||Fisher Exact|||Week 24||||0.4621
71745052|NCT02888106|143001239|SUPERIORITY|||||||0.0253|||||||Fisher Exact|||Week 24||||0.0253
71745053|NCT02888106|143001239|SUPERIORITY|||||||0.0268|||||||Fisher Exact|||Week 48||||0.0268
71745054|NCT02888106|143001239|SUPERIORITY|||||||0.6999|||||||Fisher Exact|||Week 48||||0.6999
71745055|NCT02888106|143001239|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 48||||1.0000
71745056|NCT02888106|143001239|SUPERIORITY|||||||0.0656|||||||Fisher Exact|||Week 48||||0.0656
71745057|NCT02888106|143001239|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||Week 48||||0.0005
71745058|NCT02888106|143001239|SUPERIORITY|||||||0.1431|||||||Fisher Exact|||Week 72||||0.1431
71745059|NCT02888106|143001239|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71745060|NCT02888106|143001239|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71745061|NCT02888106|143001239|SUPERIORITY|||||||1|||||||Fisher Exact|||Week 72||||1.0000
71745062|NCT02888106|143001239|SUPERIORITY|||||||0.7104|||||||Fisher Exact|||Week 72||||0.7104
71778216|NCT00131508|143055750|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.93
71778217|NCT00131508|143055751|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||0.56
71778218|NCT00131508|143055751|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.||||1.0
71778219|NCT00131508|143055751|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.||||0.61
71778220|NCT00131508|143055752|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.||||0.83
71778221|NCT00131508|143055753|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.||||0.40
71778222|NCT01479127|143055764|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Paired t-test|||"TRS I OFF state"||||0.058
71778223|NCT01479127|143055764|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Paired t-test|||"TRS I Dyskinesia state"||||1.000
71778224|NCT01479127|143055764|SUPERIORITY_OR_OTHER|||||||0.153|TWO_SIDED||||||Paired t-test|||"TRS II Normal state"||||0.153
71778225|NCT01479127|143055764|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Paired t-test|||"TRS II OFF state"||||0.140
71778226|NCT01479127|143055764|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||"TRS II Dyskinesia state"||||0.374
71778227|NCT01479127|143055765|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||||||0.574
71778228|NCT01479127|143055765|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD||||0.661
71778229|NCT01479127|143055765|SUPERIORITY_OR_OTHER|||||||0.574|TWO_SIDED||||||Paired t-test|||ON time w/o D + time with NTD + time w/ TD||||0.574
71778230|NCT01479127|143055766|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Rapid alternating movement of hands||||0.500
71778231|NCT01479127|143055766|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||Arising from chair||||1.000
71778232|NCT01479127|143055766|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Postural stability||||0.250
71778233|NCT01479127|143055766|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon one-sample test|||Body bradykinesia and hypokinesia||||0.500
71778234|NCT01479127|143055766|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Wilcoxon one-sample test|||Dyskinesia||||0.250
71778235|NCT01479127|143055767|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Paired t-test|||Total score||||0.870
71778236|NCT01479127|143055767|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Paired t-test|||Part I||||0.374
71778237|NCT01479127|143055767|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Part II||||0.799
71778238|NCT01479127|143055767|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Paired t-test|||Part II (Off-time)||||0.493
71778239|NCT01479127|143055767|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Paired t-test|||Part III||||0.530
71778240|NCT01479127|143055767|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Paired t-test|||Part IV sub-score of dyskinesia||||0.108
71778241|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Paired t-test|||Total score||||0.636
71778242|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED||||||Paired t-test|||Domain: Mobility||||0.329
71778243|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.902|TWO_SIDED||||||Paired t-test|||Domain: Activities of daily living||||0.902
71778244|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Paired t-test|||Domain: Emotional well-being||||0.220
71778245|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Paired t-test|||Domain: Stigma||||0.799
71778246|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED||||||Paired t-test|||Domain: Social support||||0.178
71778247|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Paired t-test|||Domain: Cognition||||0.456
71778248|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.866|TWO_SIDED||||||Paired t-test|||Domain: Communication||||0.866
71778249|NCT01479127|143055768|SUPERIORITY_OR_OTHER|||||||0.576|TWO_SIDED||||||Paired t-test|||Domain: Bodily discomfort||||0.576
71778250|NCT01479127|143055769|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"On state staging"||||1.000
71778251|NCT01479127|143055769|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon one-sample test|||"Off state staging"||||1.000
71778252|NCT01479127|143055770|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED||||||Wilcoxon one-sample test|||||||0.125
71778253|NCT01479127|143055775|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Paired t-test|||||||0.074
71778254|NCT03569033|143055783|OTHER||Difference in Least Squares Means|-0.32||||0.748|TWO_SIDED|95.0|-2.29|1.66|||Longitudinal Data Analysis|||||1.66|-2.29|0.748
71778255|NCT03569033|143055784|OTHER||Difference in Least Squares Means|0.99||||0.754|TWO_SIDED|95.0|-5.33|7.3|||ANCOVA|||||7.30|-5.33|0.754
71778256|NCT03569033|143055785|OTHER||Difference in Least Squares Means|0.8||||0.627|TWO_SIDED|95.0|-2.5|4.1|||ANCOVA|||||4.10|-2.50|0.627
71778257|NCT03569033|143055786|OTHER||Difference in Least Squares Means|0.09||||0.631|TWO_SIDED|95.0|-0.28|0.45|||ANCOVA|||||0.45|-0.28|0.631
71665248|NCT02027428|142844561|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4164|TWO_SIDED|95.0|0.62|1.22||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.22|0.62|0.4164
71745063|NCT02673918|143001312|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71745064|NCT02673918|143001313|EQUIVALENCE|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71745065|NCT02927392|143001333|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71745066|NCT01708317|143001339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.001||||||We used a cutoff of P\<0.05 as statistically significant.|Chi-squared|3 degrees of freedom to compare 4 time periods.||We compared testing in the 4 time frames described, including the time frame in which we enrolled patients in the ACASI.||||<.001
71745067|NCT03259555|143001346|SUPERIORITY||Treatment difference|0.14|||=|0.8797|TWO_SIDED|95.0|-1.74|2.03|||Mixed-effect Model Repeated Measure|"An unstructured covariance was used."|"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."|||2.03|-1.74|=0.8797
71745068|NCT03863509|143001439|OTHER|||||||0.494|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 384) = 0.707, p = .494||||||.494
71745069|NCT03863509|143001440|OTHER|||||||0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference F(2, 381) = 7.409, p = .001||||||0.001
71745070|NCT03863509|143001440|OTHER||Mean Difference (Final Values)|-0.42||||0.822|TWO_SIDED|95.0|-4.08|3.24|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried.||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||3.240|-4.080|0.822
71745071|NCT03863509|143001440|OTHER||Mean Difference (Final Values)|7.267||||0.001|TWO_SIDED|95.0|2.974|11.559|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||these are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.559|2.974|0.001
71745072|NCT03863509|143001440|OTHER||Mean Difference (Final Values)|7.687|||<|0.001|TWO_SIDED|95.0|3.485|11.889|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||These are pairwise follow-up tests probing a larger omnibus group difference involving three groups.||11.889|3.485|<0.001
71745073|NCT03863509|143001441|OTHER|||||||0.074||||||Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 2.616, p = .074|ANCOVA|||||||.074
71745074|NCT03863509|143001442|OTHER||Type III F-test of Fixed Group x Time ef|6.609||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Omnibus Group x Time (pre-post) interaction test: F (2, 378.467) = 6.609, p = .002. Age, race, and sex were covaried.|F (2, 378.467) = 6.609, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.002
71745075|NCT03863509|143001442|OTHER||interaction estimate|3.3|STANDARD_ERROR_OF_MEAN|0.99||0.001|TWO_SIDED|95.0|1.36|5.24|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||5.24|1.36|0.001
71745076|NCT03863509|143001442|OTHER||interaction term estimate|3.29|STANDARD_ERROR_OF_MEAN|1.06||0.002|TWO_SIDED|95.0|1.2|5.38|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in systolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive cigarette smokers x Time vs never users x time as reference|||5.38|1.20|0.002
71745077|NCT03863509|143001442|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.948||0.992|TWO_SIDED||||||ANCOVA|||||||.992
71745078|NCT03863509|143001443|OTHER||Type III F-test of Fixed Group x Time ef|5.843||||0.003|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 378.999) = 5.843, p = .003|F (2, 378.999) = 5.843, p = .003|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.003
71745079|NCT03863509|143001443|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.002|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.002
71745080|NCT03863509|143001443|OTHER||Interaction term Coefficient|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.003|TWO_SIDED|95.0|0.01|0.05|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race. Here presented the Exclusive Smokers x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||0.05|0.01|.003
71665249|NCT02027428|142844562|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0381|TWO_SIDED|95.0|0.47|0.98||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||0.98|0.47|0.0381
71745081|NCT03863509|143001443|OTHER||Interaction term Coefficient|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.917|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in diastolic blood pressure, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||||.917
71665250|NCT02027428|142844563|SUPERIORITY||Overall response rate ratio|3.15||||0.0978|TWO_SIDED|95.0|0.733|13.574||5% level of significance.|Cochran-Mantel-Haenszel||Response rate ratio: nab-paclitaxel + BSC / BSC Alone|||13.574|0.733|0.0978
71745082|NCT03863509|143001444|OTHER||Type III F-test of Fixed Group x Time Ef|49.42|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 376.099) = 49.420, p \< .001|F (2, 376.099) = 49.420, p \< .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||< .001
71745083|NCT03863509|143001444|OTHER||interaction term coefficient|6.06|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.83|7.3|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||7.3|4.83|<0.001
71745084|NCT03863509|143001444|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|0.68|<|0.001|TWO_SIDED|95.0|3.76|6.42|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||6.42|3.76|<0.001
71745085|NCT03863509|143001444|OTHER||interaction term coefficient|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.107|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Heart Rate, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.107
71778258|NCT03725852|143055794|SUPERIORITY||Least square (LS) mean difference|42.33|STANDARD_ERROR_OF_MEAN|61.483||0.495|TWO_SIDED|95.0|-81.84|166.49||P-value was based on an analysis of covariance (ANCOVA) model at each time point including treatment, sex, stratum (nintedanib, pirfenidone or neither), age, height, and baseline value as covariates.|ANCOVA|||Change at Week 26||166.49|-81.84|0.495
71778259|NCT03725852|143055795|SUPERIORITY||Difference in Percentage|1.7|||||TWO_SIDED|95.0|-17.3|24.5|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs||24.5|-17.3|
71778260|NCT03725852|143055795|SUPERIORITY||Difference in Percentage|15.7|||||TWO_SIDED|95.0|-3.0|30.7|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|Serious TEAEs||30.7|-3.0|
71778261|NCT03725852|143055795|SUPERIORITY||Difference in Percentage|31.4|||||TWO_SIDED|95.0|8.2|49.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs related to study drug||49.4|8.2|
71778262|NCT03725852|143055795|SUPERIORITY||Difference in Percentage|22.2|||||TWO_SIDED|95.0|6.7|36.4|||||95% CI for difference calculated using the method of Miettinen and Nurminen.|TEAEs leading to study drug discontinuation||36.4|6.7|
71745086|NCT03863509|143001445|OTHER||Type III F-test of Fixed Group x Time Ef|6.194||||0.002|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,372.971) = 6.194, p = .002|F (2,372.971) = 6.194, p = .002|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.002
71778263|NCT03725852|143055796|SUPERIORITY|||||||0.397|||||||Log Rank|||All-cause deaths||||0.397
71778264|NCT03725852|143055796|SUPERIORITY|||||||0.397|||||||Log Rank|||Respiratory-related deaths||||0.397
71778265|NCT03725852|143055796|SUPERIORITY|||||||0.131|||||||Log Rank|||All-cause hospitalizations||||0.131
71778266|NCT03725852|143055796|SUPERIORITY|||||||0.762|||||||Log Rank|||Respiratory-related hospitalizations||||0.762
71745087|NCT03863509|143001445|OTHER||interaction term coefficient|-0.005|STANDARD_ERROR_OF_MEAN|0.001||0.003|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.002|-0.01|0.003
71745088|NCT03863509|143001445|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.001|TWO_SIDED|95.0|-0.01|-0.002|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.002|-0.01|0.001
71745089|NCT03863509|143001445|OTHER||interaction term coefficient|-0.001|STANDARD_ERROR_OF_MEAN|0.002||0.582|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in Brachial Artery Diameter, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.582
71745090|NCT03863509|143001446|OTHER||Type III F-test of Fixed Group x Time E|1.753||||0.175|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried.|FMD responses in e-cigarette users, cigarette users, and never-users controls after adjusting for changes in brachial artery diameter.|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.175
71665251|NCT02027428|142844564|SUPERIORITY||disease control rate ratio|0.99|||||TWO_SIDED|95.0|0.978|1.007|||||Disease control rate ratio: nab-paclitaxel + BSC / BSC Alone|The rate ratio and its 95% confidence interval are based on non-stratified analysis.||1.007|0.978|
71665252|NCT02027428|142844566|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.59|1.47|||||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|Hazard ratio was based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.||1.47|0.59|
71665253|NCT01004003|142844570|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.437|||||TWO_SIDED|95.0|0.805|2.565|||||"Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.565|0.805|
71665254|NCT01004003|142844573|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.351|||||TWO_SIDED|95.0|0.779|2.343|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||2.343|0.779|
71665255|NCT01004003|142844574|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.522|1.473|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."|||1.473|0.522|
71665256|NCT01130597|142844575|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|90.5|||||TWO_SIDED|95.0|80.4|96.4|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||96.4|80.4|
71665257|NCT01130597|142844580|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|84.1|||||TWO_SIDED|95.0|72.7|92.1|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval|||92.1|72.7|
71665258|NCT05819203|142844615|SUPERIORITY|||||||0.0013|||||||Wilcoxon (Mann-Whitney)|||Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||0.0013
71665259|NCT05819203|142844616|SUPERIORITY|||||||0.0209|||||||Cox survival regression and p Wald|||Comparison of the mean duration of common cold during the study between both groups.||||0.0209
71665260|NCT05819203|142844617|SUPERIORITY|||||||0.0399|||||||Cox survival regression and p Wald|||Comparison of the mean duration of impact of common cold on quality of life during the study between both groups.||||0.0399
71665261|NCT05819203|142844618|SUPERIORITY|||||||0.0015|||||||Poisson regression|||||||0.0015
71665262|NCT05819203|142844619|SUPERIORITY||||||>|0.05||||||not significant|Poisson regression|||||||>0.05
71665263|NCT05819203|142844620|SUPERIORITY|||||||0.0029|||||||Poisson regression|||||||0.0029
71665264|NCT05819203|142844621|SUPERIORITY|||||||0.0006|||||||Poisson regression|||||||0.0006
71665265|NCT05819203|142844622|SUPERIORITY|||||||0.0513|||||||Poisson regression|||||||0.0513
71665266|NCT05819203|142844623|SUPERIORITY|||||||0.0789|||||||Poisson regression|||||||0.0789
71665267|NCT05819203|142844624|SUPERIORITY||||||<|0.0001|||||||Poisson regression|||||||<0.0001
71665268|NCT05819203|142844625|SUPERIORITY|Comparison of the means of AUC on global score or ARSSQ during the first 10 days of the study between both groups.||||||0.0034|||||||t-test, 2 sided|||||||0.0034
71665269|NCT02126826|142844666|SUPERIORITY_OR_OTHER||Slope|0.7865|||||TWO_SIDED|90.0|0.6193|0.9537|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9537|0.6193|
71665270|NCT02126826|142844666|SUPERIORITY_OR_OTHER||Slope|1.0171|||||TWO_SIDED|90.0|0.8378|1.1964|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.1964|0.8378|
71665271|NCT02126826|142844668|SUPERIORITY_OR_OTHER||Slope|0.9511|||||TWO_SIDED|90.0|0.7654|1.1367|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1367|0.7654|
71665272|NCT02126826|142844668|SUPERIORITY_OR_OTHER||Slope|1.0834|||||TWO_SIDED|90.0|0.8655|1.3013|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3013|0.8655|
71665273|NCT02126826|142844670|SUPERIORITY_OR_OTHER||Slope|0.7832|||||TWO_SIDED|90.0|0.6235|0.9428|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||0.9428|0.6235|
71665274|NCT02126826|142844670|SUPERIORITY_OR_OTHER||Slope|1.0365|||||TWO_SIDED|90.0|0.8593|1.2137|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.2137|0.8593|
71665275|NCT02126826|142844672|SUPERIORITY_OR_OTHER||Slope|0.9433|||||TWO_SIDED|90.0|0.7744|1.1122|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 300mg||1.1122|0.7744|
71665276|NCT02126826|142844672|SUPERIORITY_OR_OTHER||Slope|1.081|||||TWO_SIDED|90.0|0.8583|1.3037|||ANCOVA|||Investigation of dose proportionality - dose groups 50mg to 200mg||1.3037|0.8583|
71665277|NCT02462291|142844703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||1|TWO_SIDED|95.0|-7.9|5.4|||ANOVA|||Baseline||5.4|-7.9|1
71665278|NCT02462291|142844703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.3|||<|0.01|TWO_SIDED|95.0|26.4|40.2|||ANOVA|||After the treatment||40.2|26.4|<0.01
71665279|NCT02462291|142844703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|||<|0.01|TWO_SIDED|95.0|-38.2|-24.8|||ANOVA|||PRE Vs POST||-24.8|-38.2|<0.01
71665280|NCT02462291|142844703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||1|TWO_SIDED|95.0|-3.7|9.9|||ANOVA|||PRE Vs POST||9.9|-3.7|1
71665281|NCT02462291|142844704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||1|TWO_SIDED|95.0|-0.8|0.5|||ANOVA|||Baseline||0.5|-0.8|1
71665282|NCT02462291|142844704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94|||<|0.01|TWO_SIDED|95.0|-2.6|-1.2|||ANOVA|||After the treatment||-1.2|-2.6|<0.01
71665283|NCT02462291|142844704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.01|TWO_SIDED|95.0|0.28|1.61|||ANOVA|||PRE Vs POST||1.61|0.28|<0.01
71665284|NCT02462291|142844704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.01|TWO_SIDED|95.0|-1.52|-0.17|||ANOVA|||PRE Vs POST||-0.17|-1.52|<0.01
71665285|NCT02462291|142844705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||=|0.84|TWO_SIDED|95.0|-3.6|2.1|||ANOVA|||Baseline||2.1|-3.6|= 0.84
71665286|NCT02462291|142844705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.9|TWO_SIDED|95.0|-4.3|1.7|||ANOVA|||After the treatment||1.7|-4.3|= 0.9
71665287|NCT02462291|142844705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.88|TWO_SIDED|95.0|-3.14|2.69|||ANOVA|||PRE Vs POST||2.69|-3.14|0.88
71665288|NCT02462291|142844705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.89|TWO_SIDED|95.0|-3.73|2.16|||ANOVA|||PRE Vs POST||2.16|-3.73|0.89
71665289|NCT02462291|142844706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.9|TWO_SIDED|95.0|-5.48|2.73|||ANOVA|||Baseline||2.73|-5.48|0.9
71665290|NCT02462291|142844706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.62||||0.59|TWO_SIDED|95.0|-1.6|6.9|||ANOVA|||After the treatment||6.90|-1.60|0.59
71665291|NCT02462291|142844706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.99||||0.34|TWO_SIDED|95.0|-7.15|1.16|||ANOVA|||PRE Vs POST||1.16|-7.15|0.34
71665292|NCT02462291|142844706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.9|TWO_SIDED|95.0|-3.17|5.23|||ANOVA|||PRE Vs POST||5.23|-3.17|0.9
71745091|NCT03863509|143001446|OTHER||interaction term coefficient|0.75|STANDARD_ERROR_OF_MEAN|0.41||0.067|TWO_SIDED|95.0|-0.05|1.56|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||1.56|-0.05|0.067
71745092|NCT03863509|143001446|OTHER||interaction term coefficient|0.33|STANDARD_ERROR_OF_MEAN|0.44||0.464|TWO_SIDED|95.0|-0.55|1.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in Brachial Artery Flow Mediated Dilation, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.20|-0.55|0.464
71745093|NCT03863509|143001446|OTHER||interaction term coefficient|-0.43|STANDARD_ERROR_OF_MEAN|0.4||0.284|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing effects of group, time, and group x time in FMD, age, sex, race adjusted, for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.284
71745094|NCT03863509|143001447|OTHER||Type III F-test of Fixed Group x Time Ef|8.323|||<|0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 342.847) = 8.323, p = \<.001|F (2,342.847) = 8.323, p = \<.001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||<0.001
71778267|NCT03725852|143055797|SUPERIORITY||Weighted LS mean difference|-9.11|STANDARD_ERROR_OF_MEAN|15.713||0.565|TWO_SIDED|95.0|-40.87|22.64||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline 6MWT distance as covariates.|ANCOVA|||Change at Week 26||22.64|-40.87|0.565
71778268|NCT03725852|143055798|SUPERIORITY||Weighted LS mean difference.|-1.58|STANDARD_ERROR_OF_MEAN|3.71||0.673|TWO_SIDED|95.0|-9.06|5.91||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26||5.91|-9.06|0.673
71778269|NCT03725852|143055799|SUPERIORITY||Weighted LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|4.591||0.875|TWO_SIDED|95.0|-9.98|8.53||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Symptoms score||8.53|-9.98|0.875
71778270|NCT03725852|143055799|SUPERIORITY||Weighted LS mean difference|-4.14|STANDARD_ERROR_OF_MEAN|5.038||0.416|TWO_SIDED|95.0|-14.29|6.02||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Activity score||6.02|-14.29|0.416
71778271|NCT03725852|143055799|SUPERIORITY||Weighted LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.029||0.961|TWO_SIDED|95.0|-8.32|7.92||P-value was based on an ANCOVA model at Week 26 including treatment, stratum (nintedanib, pirfenidone or neither) and baseline SGRQ value as covariates.|ANCOVA|||Change at Week 26: Impacts score||7.92|-8.32|0.961
71778272|NCT03725852|143055800|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71834558|NCT05644002|143173247|OTHER||Mean Difference (Final Values)|2.06||||0.71|TWO_SIDED|95.0|-9.09|13.21||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||13.21|-9.09|.71
71665293|NCT02462291|142844707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.83|TWO_SIDED|95.0|-1.41|2.14|||ANOVA|||Baseline||2.14|-1.41|0.83
71665294|NCT02462291|142844707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69|||<|0.01|TWO_SIDED|95.0|0.84|4.53|||ANOVA|||After the treatment||4.53|0.84|<0.01
71665295|NCT02462291|142844707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14||||0.01|TWO_SIDED|95.0|-3.94|-0.34|||ANOVA|||PRE Vs POST||-0.34|-3.94|0.010
71665296|NCT02462291|142844707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.84|TWO_SIDED|95.0|-1.64|2.0|||ANOVA|||PRE Vs POST||2.00|-1.64|0.84
71665297|NCT02462291|142844708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.11|TWO_SIDED|95.0|-0.16|2.95|||ANOVA|||Baseline||2.95|-0.16|0.11
71745095|NCT03863509|143001447|OTHER||interaction term coefficient|-6.55|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-9.89|-3.2|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-3.20|-9.89|<0.001
71745096|NCT03863509|143001447|OTHER||interaction term coefficient|-6.11|STANDARD_ERROR_OF_MEAN|1.83||0.001|TWO_SIDED|95.0|-9.71|-2.52|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-2.52|-9.71|0.001
71745097|NCT03863509|143001447|OTHER||interaction term coefficient|0.44|STANDARD_ERROR_OF_MEAN|1.61||0.787|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in PNN50, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.787
71745098|NCT03863509|143001448|OTHER||Type III F-test of Fixed Group x Time Ef|7.26||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 345.918) = 7.260, p = .001|F (2,345.918) = 7.260, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
71778273|NCT03072732|143055825|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 1 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.75|0.57|
71778274|NCT03072732|143055825|NON_INFERIORITY|The µ-Cor System will be considered non-inferior with respect to clinical performance (i.e., trends in fluid change) of the ZOE device if the lower 95% confidence interval of the differences (Primary Measurement) is greater than the non-inferiority margin of -0.05.|Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.12|0.35|||||"Because the distribution was skewed, the average was calculated by 1) Fisher Transformation of values, 2) averaging the transformed values, 3) back calculating the mean.~The Taylor Series expansion and Delta method was used to determine variance."|"The null hypothesis was that the correlation coefficient of the ZOE device would be greater than the correlation coefficient of the uCor device by at least 0.05.~For each subject, a correlation coefficient was calculated between study arm 2 uCor readings and UFV, as well as ZOE readings and UFV.~The difference between uCor correlation coefficient and ZOE correlation coefficient for each subject was used as the Primary Measurement."||0.35|0.12|
71778275|NCT00116428|143055828|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.||||<0.001
71778276|NCT04402060|143055838|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.82|TWO_SIDED|90.0|0.63|1.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% confidence interval (CI) was based on the Wald method.||1.51|0.63|0.82
71778277|NCT04402060|143055839|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.36|TWO_SIDED|90.0|0.77|3.4|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||3.40|0.77|0.36
71778278|NCT04402060|143055841|SUPERIORITY||Hazard Ratio (HR)|0.09||||0.03|TWO_SIDED|90.0|0.01|0.51|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||0.51|0.01|0.03
71778279|NCT04402060|143055842|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.93|TWO_SIDED|90.0|0.69|1.72|||Log Rank|||P-value was from a 2-sided stratified Log-rank test by the randomization stratification factors (need of mechanical ventilation \[yes vs no\] and age \[\<65 years vs ≥65 years\]) at 0.1 significant level for evaluation of treatment difference. Hazard ratio was obtained from a Cox regression model with treatment and the randomization stratification factors as fixed factors and 90% CI was based on the Wald method.||1.72|0.69|0.93
71778280|NCT02256072|143055855|SUPERIORITY_OR_OTHER||Slope|1.25|STANDARD_ERROR_OF_MEAN|0.45||0.0054|TWO_SIDED|95.0|0.37|2.12|||ANCOVA|||H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.||2.12|0.37|0.0054
71665298|NCT02462291|142844708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.7|TWO_SIDED|95.0|-0.81|2.41|||ANOVA|||After the treatment||2.41|-0.81|0.7
71834559|NCT05644002|143173247|OTHER||t-statistic|0.369|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Omax between the PTBT and Control conditions.||||
71665299|NCT02462291|142844708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.88|TWO_SIDED|95.0|-1.17|1.98|||ANOVA|||PRE Vs POST||1.98|-1.17|0.88
71665300|NCT02462291|142844708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.95|TWO_SIDED|95.0|-1.78|1.39|||ANOVA|||PRE Vs POST||1.39|-1.78|0.95
71665301|NCT02462291|142844709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.95|TWO_SIDED|95.0|-0.67|0.4|||ANOVA|||Baseline||0.40|-0.67|0.95
71665302|NCT02462291|142844709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.23|TWO_SIDED|95.0|-0.12|0.99|||ANOVA|||After the treatment||0.99|-0.12|0.23
71665303|NCT02462291|142844709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.96|TWO_SIDED|95.0|-0.65|0.44|||ANOVA|||PRE Vs POST||0.44|-0.65|0.96
71778281|NCT02256072|143055856|SUPERIORITY_OR_OTHER||Slope|0.244|STANDARD_ERROR_OF_MEAN|0.123||0.0471|TWO_SIDED|||||P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.||||0.0471
71778282|NCT02256072|143055857|SUPERIORITY_OR_OTHER||Slope|0.075|STANDARD_ERROR_OF_MEAN|0.094||0.423|TWO_SIDED|||||p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.|The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.|H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.||||0.423
71778283|NCT02256072|143055858|SUPERIORITY_OR_OTHER||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|||||p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.||||<0.0001
71778284|NCT02572609|143055900|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|113.56|STANDARD_DEVIATION|16.24||0.0082|TWO_SIDED|90.0|106.48|121.1|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||121.10|106.48|0.0082
71778285|NCT02572609|143055901|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence in the AUC0-t will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|119.61|STANDARD_DEVIATION|10.65||0.0438|TWO_SIDED|90.0|114.65|124.79|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).|||124.79|114.65|0.0438
71778286|NCT02345226|143055908|NON_INFERIORITY|A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-2.0|||||TWO_SIDED|95.001|-5.9|1.8|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.||1.8|-5.9|
71778287|NCT02345226|143055908|SUPERIORITY|||||||0.35|||||||Fisher Exact|||||||0.35
71778288|NCT01848704|143055932|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||Mixed Models Analysis|||||1.35|0.07|0.03
71778289|NCT01848704|143055933|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.03|TWO_SIDED|95.0|-1.13|-0.05|||Mixed Models Analysis|||||-0.05|-1.13|0.03
71834560|NCT05644002|143173247|OTHER||Hedge's g|0.09|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Omax between the PTBT and Control conditions.||||
71778290|NCT01848704|143055934|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.18|TWO_SIDED|95.0|-0.95|0.19|||Mixed Models Analysis|||||0.19|-0.95|0.18
71778291|NCT01848704|143055935|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.029|TWO_SIDED|95.0|0.08|1.47|||Mixed Models Analysis|||||1.47|0.08|0.029
71778292|NCT01848704|143055936|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.061|TWO_SIDED|95.0|-0.03|1.31|||Mixed Models Analysis|||||1.31|-0.03|0.061
71834561|NCT05644002|143173248|OTHER||Mean Difference (Final Values)|0.251||||0.53|TWO_SIDED|95.0|-0.543|1.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||1.046|-.543|.530
71665304|NCT02462291|142844709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.15|TWO_SIDED|95.0|-0.08|1.01|||ANOVA|||PRE Vs POST||1.01|-0.08|0.15
71834562|NCT05644002|143173248|OTHER||t-statistic|0.631|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
71665305|NCT02462291|142844710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.84|TWO_SIDED|95.0|-1.14|1.27|||ANOVA|||Baseline||1.27|-1.14|0.84
71778293|NCT02155881|143055964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9716|TWO_SIDED|95.0|-0.98|1.01|||ANCOVA|||An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.01|-0.98|0.9716
71834563|NCT05644002|143173248|OTHER||Hedge's g|0.14|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ cigarette satisfaction between the PTBT and Control conditions.||||
71834564|NCT05644002|143173249|OTHER||Mean Difference (Final Values)|0.889||||0.66|TWO_SIDED|95.0|-3.149|4.927||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress intensity between the PTBT and Control conditions.||4.927|-3.149|.66
71745099|NCT03863509|143001448|OTHER||interaction term coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.31|-0.08|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.08|-0.31|0.001
71745100|NCT03863509|143001448|OTHER||interaction term coefficient|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.33|-0.09|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||-0.09|-0.33|0.001
71745101|NCT03863509|143001448|OTHER||interaction term coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.847|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in RMSSD, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.847
71745102|NCT03863509|143001449|OTHER||Type III F-test of Fixed Group x Time Ef|1.712||||0.182|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 312.081) = 1.712, p = .182|F (2, 312.081) = 1.712, p = .182|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||.182
71778294|NCT02155881|143055965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.8713|TWO_SIDED|95.0|-0.87|1.02|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||1.02|-0.87|0.8713
71778295|NCT02155881|143055966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.7789|TWO_SIDED|95.0|-0.61|0.81|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.81|-0.61|0.7789
71834565|NCT05644002|143173249|OTHER||t-statistic|0.439|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction intensity between the PTBT and Control conditions.||||
71834566|NCT05644002|143173249|OTHER||Hedge's g|-0.11|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction intensity between the PTBT and Control conditions.||||
71834567|NCT05644002|143173250|OTHER||Mean Difference (Final Values)|-0.698||||0.77|TWO_SIDED|95.0|-5.443|4.046||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||4.046|-5.443|.77
71665306|NCT02462291|142844710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.81|TWO_SIDED|95.0|-0.96|1.54|||ANOVA|||After the treatment||1.54|-0.96|0.81
71834568|NCT05644002|143173250|OTHER||t-statistic|-0.294|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction Pmax between the PTBT and Control conditions.||||
71834569|NCT05644002|143173250|OTHER||Hedge's g|-0.071|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction Pmax between the PTBT and Control conditions.||||
71745103|NCT03863509|143001449|OTHER||interaction term coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.07|TWO_SIDED|95.0|-0.09|0.004|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||0.004|-0.09|0.07
71745104|NCT03863509|143001449|OTHER||interaction term coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.196|TWO_SIDED|95.0|-0.09|0.02|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.02|-0.09|0.196
71745105|NCT03863509|143001449|OTHER||interaction term coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.02||0.69|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in HRV-Standing Ratio adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.69
71745106|NCT03863509|143001450|OTHER||Type III F-test of Fixed Group x Time Ef|4.096||||0.017|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.239) = 4.096, p = .017|F (2, 373.239) = 4.096, p = .017|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.017
71745107|NCT03863509|143001450|OTHER||interaction term coefficient|-3.04|STANDARD_ERROR_OF_MEAN|1.09||0.005|TWO_SIDED|95.0|-5.18|-0.91|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-0.91|-5.18|0.005
71665307|NCT02462291|142844710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.86|TWO_SIDED|95.0|-1.71|0.74|||ANOVA|||PRE Vs POST||0.74|-1.71|0.86
71665308|NCT02462291|142844710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.75|TWO_SIDED|95.0|-1.49|0.97|||ANOVA|||PRE Vs POST||0.97|-1.49|0.75
71745108|NCT03863509|143001450|OTHER||interaction term coefficient|-1.29|STANDARD_ERROR_OF_MEAN|1.18||0.274|TWO_SIDED|95.0|-3.61|1.03|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.03|-3.61|0.274
71745109|NCT03863509|143001450|OTHER||interaction term coefficient|1.75|STANDARD_ERROR_OF_MEAN|1.06||0.098|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.098
71745110|NCT03863509|143001451|OTHER||Type III F-test of Fixed Group x Time Ef|0.26||||0.771|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.434) = 0.260, p = .771|F (2, 373.434) = 0.260, p = .771|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||.771
71745111|NCT03863509|143001451|OTHER||interaction term coefficient|-0.12|STANDARD_ERROR_OF_MEAN|1.14||0.918|TWO_SIDED|95.0|-2.35|2.12|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||2.12|-2.35|0.918
71745112|NCT03863509|143001451|OTHER||interaction term coefficient|-0.8|STANDARD_ERROR_OF_MEAN|1.23||0.518|TWO_SIDED|95.0|-3.22|1.63|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.63|-3.22|0.518
71778296|NCT02155881|143055967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.663|TWO_SIDED|95.0|-0.55|0.86|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.86|-0.55|0.6630
71778297|NCT02155881|143055968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.5593|TWO_SIDED|95.0|-0.35|0.19|||ANCOVA|||Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.19|-0.35|0.5593
71778298|NCT02155881|143055968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7085|TWO_SIDED|95.0|-0.22|0.33|||ANCOVA|||Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.22|0.7085
71778299|NCT02155881|143055968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.7309|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.22|0.7309
71665309|NCT02462291|142844711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7||||0.94|TWO_SIDED|95.0|-74.4|44.9|||ANOVA|||Baseline||44.9|-74.4|0.94
71665310|NCT02462291|142844711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.36||||0.87|TWO_SIDED|95.0|-53.47|70.2|||ANOVA|||After the treatment||70.20|-53.47|0.87
71665311|NCT02462291|142844711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7||||0.78|TWO_SIDED|95.0|-90.19|30.78|||ANOVA|||PRE Vs POST||30.78|-90.19|0.78
71665312|NCT02462291|142844711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.84|TWO_SIDED|95.0|-67.7|54.5|||ANOVA|||PRE Vs POST||54.5|-67.7|0.84
71665313|NCT02462291|142844712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.74|TWO_SIDED|95.0|-3.73|4.56|||ANOVA|||Baseline||4.56|-3.73|0.74
71745113|NCT03863509|143001451|OTHER||interaction term coefficient|-0.68|STANDARD_ERROR_OF_MEAN|1.11||0.539|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.539
71745114|NCT03863509|143001452|OTHER||Type III F-test of Fixed Group x Time Ef|7.157||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 375.412) = 7.157, p = .001|F (2, 375.412) = 7.157, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use.||||0.001
71745115|NCT03863509|143001452|OTHER||interaction term coefficient|-3.39|STANDARD_ERROR_OF_MEAN|1.04||0.001|TWO_SIDED|95.0|-5.43|-1.35|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|||-1.35|-5.43|0.001
71745116|NCT03863509|143001452|OTHER||interaction term coefficient|-0.32|STANDARD_ERROR_OF_MEAN|1.12||0.778|TWO_SIDED|95.0|-2.53|1.89|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||1.89|-2.53|0.778
71745117|NCT03863509|143001452|OTHER||interaction term coefficient|3.08|STANDARD_ERROR_OF_MEAN|1.08||0.002|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEV1/FVC, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.002
71778300|NCT02155881|143055968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9584|TWO_SIDED|95.0|-0.29|0.3|||ANCOVA|||Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.30|-0.29|0.9584
71745118|NCT03863509|143001453|OTHER||Type III F-test of Fixed Group x Time Ef|4.317||||0.014|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2, 373.170) = 4.317, p = .014|F (2, 373.170) = 4.317, p = .014|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and between-group responses following product use||||0.014
71745119|NCT03863509|143001453|OTHER||interaction term coefficient|-5.08|STANDARD_ERROR_OF_MEAN|2.1||0.016|TWO_SIDED|95.0|-9.21|-0.95|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.95|-9.21|0.016
71745120|NCT03863509|143001453|OTHER||interaction term coefficient|0.01|STANDARD_ERROR_OF_MEAN|2.28||0.998|TWO_SIDED|95.0|-4.47|4.48|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||4.48|-4.47|0.998
71745121|NCT03863509|143001453|OTHER||interaction term coefficient|5.09|STANDARD_ERROR_OF_MEAN|2.04||0.013|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FEF 25-75, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.013
71778301|NCT02155881|143055969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.2266|TWO_SIDED|95.0|-0.11|0.46|||ANCOVA|||Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.46|-0.11|0.2266
71778302|NCT02155881|143055969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.4888|TWO_SIDED|95.0|-0.35|0.17|||ANCOVA|||Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.17|-0.35|0.4888
71778303|NCT02155881|143055969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8316|TWO_SIDED|95.0|-0.22|0.27|||ANCOVA|||Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.27|-0.22|0.8316
71778304|NCT02155881|143055970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2968|TWO_SIDED|95.0|-0.8|0.25|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.25|-0.80|0.2968
71778305|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.3533|TWO_SIDED|95.0|-0.85|0.31|||ANCOVA|||Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.31|-0.85|0.3533
71778306|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.3712|TWO_SIDED|95.0|-0.84|0.32|||ANCOVA|||Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.32|-0.84|0.3712
71665314|NCT02462291|142844712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25||||0.82|TWO_SIDED|95.0|-5.54|3.04|||ANOVA|||After the treatment||3.04|-5.54|0.82
71778307|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4098|TWO_SIDED|95.0|-0.69|0.29|||ANCOVA|||Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.29|-0.69|0.4098
71778308|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.2683|TWO_SIDED|95.0|-1.0|0.28|||ANCOVA|||Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.28|-1.00|0.2683
71778309|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4643|TWO_SIDED|95.0|-0.82|0.38|||ANCOVA|||Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.38|-0.82|0.4643
71665315|NCT02462291|142844712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.59|TWO_SIDED|95.0|-3.57|4.82|||ANOVA|||PRE Vs POST||4.82|-3.57|0.59
71745122|NCT03863509|143001454|OTHER||Type III F-test of Fixed Group x Time Ef|6.694||||0.001|TWO_SIDED|||||False Discovery Rate correction (Benjamini and Hochberg procedure) applied to a set of 13 Group x Time interaction tests.|Mixed Models Analysis|Age, race, and sex were covaried. Omnibus Group x Time (pre-post) interaction test: F (2,376.779) = 6.694, p = .001|F ((2,376.779) = 6.694, p = .001|Linear mixed models adjusted for age, sex, race/ethnicity compared the within-and-between-group responses following product use Outcome measure ln transformed for analysis.||||0.001
71745123|NCT03863509|143001454|OTHER||interaction term coefficient|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|-0.14|-0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs never users x time as reference|Fixed effects from mixed models of measures before and after nicotine-containing product challenge (covariate-adjusted)||-0.04|-0.14|0.001
71745124|NCT03863509|143001454|OTHER||interaction term coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.555|TWO_SIDED|95.0|-0.08|0.04|||Mixed Models Analysis||fixed effects from linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive Smokers x Time vs never users x time as reference|||0.04|-0.08|0.555
71745125|NCT03863509|143001454|OTHER||interaction term coefficient|0.007|STANDARD_ERROR_OF_MEAN|0.03||0.007|TWO_SIDED||||||Mixed Models Analysis||fixed effects from re-parameterized linear mixed model testing for effects of group, time, and group x time in FeNO, adjusting for age, sex, and race for Exclusive E-cigarette users x Time vs Exclusive Smokers x time as reference|||||0.007
71778310|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.4502|TWO_SIDED|95.0|-0.74|0.33|||ANCOVA|||Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.33|-0.74|0.4502
71778311|NCT02155881|143055971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.177|TWO_SIDED|95.0|-0.95|0.18|||ANCOVA|||Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.||0.18|-0.95|0.1770
71665316|NCT02462291|142844712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.69|TWO_SIDED|95.0|-5.28|3.19|||ANOVA|||PRE Vs POST||3.19|-5.28|0.69
71665317|NCT02462291|142844713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.9|TWO_SIDED|95.0|-0.64|1.09|||ANOVA|||Baseline||1.09|-0.64|0.9
71778312|NCT02663908|143056010|OTHER||Hazard Ratio (HR)|1.283||||0.5294|TWO_SIDED|95.0|0.589|2.794|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.794|0.589|0.5294
71778313|NCT02663908|143056011|OTHER||Hazard Ratio (HR)|1.204||||0.7126|TWO_SIDED|95.0|0.448|3.234|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||3.234|0.448|0.7126
71778314|NCT02663908|143056012|OTHER||Hazard Ratio (HR)|0.186||||0.0853|TWO_SIDED|95.0|0.022|1.595|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.595|0.022|0.0853
71778315|NCT02663908|143056013|OTHER||Hazard Ratio (HR)|1.594||||0.5196|TWO_SIDED|95.0|0.381|6.673|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||6.673|0.381|0.5196
71778316|NCT02663908|143056014|OTHER||Hazard Ratio (HR)|0.899||||0.8966|TWO_SIDED|95.0|0.181|4.457|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||4.457|0.181|0.8966
71778317|NCT02663908|143056015|OTHER||Hazard Ratio (HR)|0.48||||0.3857|TWO_SIDED|95.0|0.088|2.62|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.620|0.088|0.3857
71778318|NCT02663908|143056016|OTHER||Hazard Ratio (HR)|0.839||||0.718|TWO_SIDED|95.0|0.324|2.176|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||2.176|0.324|0.7180
71665318|NCT02462291|142844713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.01|TWO_SIDED|95.0|1.96|3.76|||ANOVA|||After the treatment||3.76|1.96|<0.01
71778319|NCT02663908|143056018|OTHER||Hazard Ratio (HR)|0.887||||0.6701|TWO_SIDED|95.0|0.512|1.539|||Log Rank|The p-value of the log-rank test is based on comparison of the treatment groups stratified for age group and region.|Baseline hazards for the Cox regression were stratified over variables: age group and region.|||1.539|0.512|0.6701
71665319|NCT02462291|142844713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|||<|0.01|TWO_SIDED|95.0|-3.8|-2.04|||ANOVA|||PRE Vs POST||-2.04|-3.80|<0.01
71665320|NCT02462291|142844713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.88|TWO_SIDED|95.0|-1.17|0.59|||ANOVA|||PRE Vs POST||0.59|-1.17|0.88
71778320|NCT02663908|143056019|OTHER||Treatment Difference|-0.907||||0.1193|TWO_SIDED|95.0|-2.048|0.235|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 168||0.235|-2.048|0.1193
71778321|NCT02663908|143056019|OTHER||Treatment Difference|-0.213||||0.108|TWO_SIDED|95.0|-0.473|0.047|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 168||0.047|-0.473|0.1080
71834570|NCT05644002|143173251|OTHER||Mean Difference (Final Values)|-0.354||||0.9|TWO_SIDED|95.0|-6.009|5.3||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||5.300|-6.009|.90
71834571|NCT05644002|143173251|OTHER||t-statistic|-0.125|||||TWO_SIDED||||||t-test, 2 sided|degrees of freedom = 66||An independent-samples t-test was conducted to examine differences in post-stress induction breakpoint between the PTBT and Control conditions.||||
71834572|NCT05644002|143173251|OTHER||Hedge's g|-0.03|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction breakpoint between the PTBT and Control conditions.||||
71665321|NCT02462291|142844714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.83|TWO_SIDED|95.0|-0.72|0.37|||ANOVA|||Baseline||0.37|-0.72|0.83
71778322|NCT02663908|143056019|OTHER||Treatment Difference|-0.916||||0.1256|TWO_SIDED|95.0|-2.089|0.257|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS Total at Day 336||0.257|-2.089|0.1256
71778323|NCT02663908|143056019|OTHER||Treatment Difference|-0.047||||0.7261|TWO_SIDED|95.0|-0.312|0.218|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||IPSS, QoL at Day 336||0.218|-0.312|0.7261
71778324|NCT02663908|143056023|OTHER||Treatment difference|-0.002||||0.911|TWO_SIDED|95.0|-0.036|0.032|||ANCOVA|Compared using an ANCOVA model, where the QALY is the dependent variable and adjusted for treatment group, age group and region, respectively.||||0.032|-0.036|0.9110
71665322|NCT02462291|142844714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.005|TWO_SIDED|95.0|0.15|1.29|||ANOVA|||After the treatment||1.29|0.15|0.005
71665323|NCT02462291|142844714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.013|TWO_SIDED|95.0|-1.21|-0.09|||ANOVA|||PRE Vs POST||-0.09|-1.21|0.013
71665324|NCT02462291|142844714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.87|TWO_SIDED|95.0|-0.31|0.81|||ANOVA|||PRE Vs POST||0.81|-0.31|0.87
71665325|NCT02462291|142844715|SUPERIORITY_OR_OTHER||Chi-squared value|0.542|||=|0.91|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.082; 3 degrees of freedom|||||= 0.910
71745126|NCT03863509|143001455|OTHER||||||<|0.001||||||ANCOVA for group differences|ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 12.869, p \< .001||||||< .001
71745127|NCT03863509|143001455|OTHER||Mean Difference (Final Values)|1.352||||0.269|TWO_SIDED|95.0|-1.048|3.752|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||3.752|-1.048|0.269
71778325|NCT02663908|143056024|OTHER||Treatment Difference|-1.57||||0.0936|TWO_SIDED|95.0|-3.41|0.27|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 168||0.27|-3.41|0.0936
71665326|NCT02462291|142844716|SUPERIORITY_OR_OTHER||Chi-squared value|17.73|||<|0.001|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.965; 3 degrees of freedom|||||<0.001
71665327|NCT02462291|142844717|SUPERIORITY_OR_OTHER||Chi-squared value|5.749||||0.124|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.488; 3 degrees of freedom|||||0.124
71778326|NCT02663908|143056024|OTHER||Treatment Difference|0.84||||0.4|TWO_SIDED|95.0|-1.11|2.78|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||DASI at Day 336||2.78|-1.11|0.4000
71778327|NCT02663908|143056025|OTHER||Treatment Difference|0.045||||0.2535|TWO_SIDED|95.0|-0.032|0.122|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 168||0.122|-0.032|0.2535
71778328|NCT02663908|143056025|OTHER||Treatment Difference|0.036||||0.437|TWO_SIDED|95.0|-0.055|0.127|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 168||0.127|-0.055|0.4370
71778329|NCT02663908|143056025|OTHER||Treatment Difference|0.116||||0.0852|TWO_SIDED|95.0|-0.016|0.248|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 168||0.248|-0.016|0.0852
71778330|NCT02663908|143056025|OTHER||Treatment Difference|0.012||||0.8156|TWO_SIDED|95.0|-0.087|0.111|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 168||0.111|-0.087|0.8156
71778331|NCT02663908|143056025|OTHER||Treatment Difference|0.051||||0.2299|TWO_SIDED|95.0|-0.033|0.135|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ Global Score at Day 336||0.135|-0.033|0.2299
71778332|NCT02663908|143056025|OTHER||Treatment Difference|0.038||||0.444|TWO_SIDED|95.0|-0.06|0.136|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Attention at Day 336||0.136|-0.060|0.4440
71778333|NCT02663908|143056025|OTHER||Treatment Difference|0.007||||0.9172|TWO_SIDED|95.0|-0.131|0.146|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Avoidance at Day 336||0.146|-0.131|0.9172
71778334|NCT02663908|143056025|OTHER||Treatment Difference|0.093||||0.1028|TWO_SIDED|95.0|-0.019|0.204|||ANCOVA|ANCOVA with the baseline score as a covariate, and treatment group, age group, region, visit, and treatment by visit interaction as factors.||CAQ domain score for Fear at Day 336||0.204|-0.019|0.1028
71665328|NCT02462291|142844718|SUPERIORITY_OR_OTHER||Chi-squared value|0.008||||1|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.050; 3 degrees of freedom|||||1
71665329|NCT02462291|142844719|SUPERIORITY_OR_OTHER||Chi-squared value|1.049||||0.789|TWO_SIDED||||||Chi-squared||Power of performed test with alpha = 0.050: 0.116; 3 degrees of freedom|||||0.789
71778335|NCT00319501|143056037|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55||||0.012|TWO_SIDED|95.0|0.34|0.88||p-value is adjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Cox Proportional Hazard||Age adjusted|Null hypothesis||0.88|0.34|0.012
71778336|NCT00319501|143056039|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.066
71778337|NCT00319501|143056040|SUPERIORITY_OR_OTHER|||||||0.443|||||||Fisher Exact|||||||0.443
71778338|NCT00319501|143056041|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact|||||||0.245
71665330|NCT02111603|142844720|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of on-treatment total fecal bile acid excretion with baseline total fecal bile acid excretion.||||0.012
71745128|NCT03863509|143001455|OTHER||Mean Difference (Final Values)|-5.575|||<|0.001|TWO_SIDED|95.0|-8.37|-2.78|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||-2.780|-8.37|<0.001
71745129|NCT03863509|143001455|OTHER||Mean Difference (Final Values)|-6.927|||<|0.001|TWO_SIDED|95.0|-9.672|-4.183|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried.||Exclusive E-Cig Users minus Exclusive Smokers||-4.183|-9.672|<0.001
71745130|NCT03863509|143001456|OTHER|||||||0.035|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 3.392, p = .035|||Group difference did not survive correction for false discovery rate at .05, therefore not followed with post-hoc pairwise comparisons.|||.035
71745131|NCT03863509|143001457|OTHER|||||||0.549|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 0.601, p = .549||||||.549
71745132|NCT03863509|143001458|OTHER|||||||0.022|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 381) = 3.877, p = .022|||Group difference tested after correction for false discovery rate at .05, therefore we followed with post-hoc pairwise comparisons.|||.022
71745133|NCT03863509|143001458|OTHER|||||||0.952|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||||0.952
71665331|NCT03106987|142844726|OTHER||Hazard Ratio (HR)|0.566||||0.022|TWO_SIDED|95.0|0.372|0.868|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.868|0.372|0.0220
71665332|NCT03106987|142844726|OTHER||Hazard Ratio (HR)|0.43||||0.0023|TWO_SIDED|95.0|0.264|0.708|||Stratified log-rank||Hazard Ratio (Cox Proportional Hazards model)|||0.708|0.264|0.0023
71665333|NCT02114385|142844737|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.23|||<|0.001|TWO_SIDED|95.0|1.04|1.45|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 6||1.45|1.04|<0.001
71665334|NCT02114385|142844737|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 11||1.04|0.76|<0.001
71665335|NCT02114385|142844737|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.21|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.21|0.89|<0.001
71665336|NCT02114385|142844737|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.50|GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.91|1.37|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.37|0.91|<0.001
71665337|NCT01753297|142844751|OTHER|||||||0.158|||||||Log Rank|||A two-sided log-rank test was used to compare time to BRFS between both treatment groups.|Analysis on BRFS was based on 61 BR events (comprised of 35 BR events in the active surveillance arm and 26 BR events in the triptorelin arm).|||0.158
71778339|NCT00319501|143056042|SUPERIORITY_OR_OTHER||Difference in least square means|0.75||||0.086|TWO_SIDED|95.0|-0.11|1.61||p-Value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|ANOVA|ANOVA=analysis of variance.|Model included treatment and age category.|||1.61|-0.11|0.086
71778340|NCT00319501|143056043|SUPERIORITY_OR_OTHER||Difference in least square means|0.79||||0.045|TWO_SIDED|95.0|0.02|1.56||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|ANOVA||Model included treatment and age category.|||1.56|0.02|0.045
71665338|NCT01753297|142844751|OTHER||Hazard Ratio (HR)|0.65||||0.1|TWO_SIDED|95.0|0.38|1.09|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute hazards ratios (HRs) and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||1.09|0.38|0.100
71665339|NCT01753297|142844751|OTHER||Hazard Ratio (HR)|1.49||||0.502|TWO_SIDED|95.0|0.46|4.79|||Regression, Cox|||"Comparison between countries: Russia compared to China.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and country: p=0.970.|4.79|0.46|0.502
71665340|NCT01753297|142844751|OTHER|||||||0.671|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and centre: p=0.241.|||0.671
71665341|NCT01753297|142844751|OTHER||Hazard Ratio (HR)|2.35||||0.093|TWO_SIDED|95.0|0.87|6.39|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of =7 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."|Interactions effect between treatment group and each covariate (country, centre(country) and Gleason score) were tested one by one in separate models. An interaction effect was considered as significant if p-value was \<0.20. Interaction between treatment group and Gleason score: p=0.272.|6.39|0.87|0.093
71665342|NCT01753297|142844751|OTHER||Hazard Ratio (HR)|2.03||||0.168|TWO_SIDED|95.0|0.74|5.55|||Regression, Cox|||"Comparison between Gleason score categories: Gleason score of ≥8 compared to Gleason score ≤6.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||5.55|0.74|0.168
71665343|NCT01753297|142844753|OTHER|||||||0.639|||||||Log Rank|||A two-sided log-rank test was used to compare time to EFS between both treatment groups.|Analysis was based on 2 EFS events in the active surveillance arm and 3 EFS events in the triptorelin arm.|||0.639
71665344|NCT01753297|142844753|OTHER||Hazard Ratio (HR)|1.52||||0.653|TWO_SIDED|95.0|0.24|9.59|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||9.59|0.24|0.653
71778341|NCT02612129|143056065|SUPERIORITY||Least Square (LS) Mean Difference|-1.4||||0.0456|TWO_SIDED|95.0|-2.76|-0.03|||GLMM for Repeated Measures|||A general linear mixed model (GLMM) for repeated measurements was used for the analysis of NPC disease severity assessed based on the 5-domain NPCCSS scores at Month 12. The general linear mixed model analysis for repeated measures was fitted with treatment, miglustat level and visit as fixed effects including treatment-by-visit interaction and baseline score as a covariate.||-0.03|-2.76|0.0456
71778342|NCT02612129|143056066|SUPERIORITY|||||||1|||||||Chi-squared Test|||||||1.0000
71778343|NCT02612129|143056067|SUPERIORITY|||||||0.5456|||||||Chi-squared Test|||||||0.5456
71778344|NCT02612129|143056068|SUPERIORITY|||||||0.8021|||||||Log-Rank Test|||Log-rank test had been stratified by miglustat use.||||0.8021
71778345|NCT02612129|143056069|SUPERIORITY|||||||0.3662|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 6||||0.3662
71778346|NCT02612129|143056069|SUPERIORITY|||||||1|||||||Fisher's Exact Test|||Percentage of participants worsening at Month 12||||1.0000
71778347|NCT02612129|143056070|SUPERIORITY||LS Mean Difference|-1.69||||0.1546|TWO_SIDED|95.0|-4.04|0.66|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 6 was analyzed using the Analysis of covariance (ANCOVA) model. ANCOVA model was fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||0.66|-4.04|0.1546
71778348|NCT02612129|143056070|SUPERIORITY||LS Mean Difference|-1.61||||0.2199|TWO_SIDED|95.0|-4.24|1.01|||ANCOVA|||Change From Baseline in 17-Domain NPCCSS Apart from Hearing Domains (i.e. Hearing and Auditory Brainstem Response) at Month 12 was analyzed using the ANCOVA model. ANCOVA model is fitted with treatment, baseline full-scale NPCCSS apart from hearing domains score, and use of miglustat as covariates.||1.01|-4.24|0.2199
71834573|NCT05644002|143173252|OTHER||Mean Difference (Final Values)|-0.748||||0.09|TWO_SIDED|95.0|-1.601|0.105||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||.105|-1.601|.09
71834574|NCT05644002|143173252|OTHER||t-statistic|-1.75|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 65.261||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ craving reduction between the PTBT and Control conditions.||||
71834575|NCT05644002|143173252|OTHER||Hedge's g|-0.405|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ craving reduction between the PTBT and Control conditions.||||
71665345|NCT01753297|142844753|OTHER|||||||0.999|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.999
71745134|NCT03863509|143001458|OTHER|||||||0.014|||||||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||post hoc pairwise group comparisons.. Never Users minus Exclusive Smokers||||0.014
71745135|NCT03863509|143001458|OTHER|||||||0.011||||||Age, sex, and race were covaried|ANCOVA post-hoc pairwise group compariso|||Exclusive E-Cig Users minus Exclusive Smokers||||0.011
71778349|NCT02612129|143056071|SUPERIORITY||Least Square (LS) Mean Difference|-1.11||||0.0188|TWO_SIDED|95.0|-2.03|-0.19|||ANCOVA|||An ANCOVA model was fitted with treatment, baseline 5-domain NPCCSS score, and use of miglustat as covariates.||-0.19|-2.03|0.0188
71745136|NCT03863509|143001459|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Outcome variable log-transformed for analysis. Test for group difference: F (2, 381) = 33.442, p \< .001|||Group difference tested for false discovery rate at .05 and followed with post-hoc pairwise comparisons.|||< .001
71745137|NCT03863509|143001459|OTHER||Mean Difference (Final Values)|0.18||||0.013|TWO_SIDED|95.0|0.039|0.322|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive E-Cig Users:||0.322|0.039|0.013
71745138|NCT03863509|143001459|OTHER||Mean Difference (Final Values)|0.679|||<|0.001|TWO_SIDED|95.0|0.514|0.844|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried|Estimated marginal mean differences (log-transformed scale)|Never Users minus Exclusive Smokers||0.844|0.514|<0.001
71745139|NCT03863509|143001459|OTHER||Mean Difference (Final Values)|0.498|||<|0.001|TWO_SIDED|95.0|0.336|0.66|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race/ethnicity were covaried|"Estimated marginal mean differences (log-transformed scale)"|Exclusive E-Cig users minus Exclusive Smokers||0.660|0.336|<0.001
71745140|NCT03863509|143001460|OTHER|||||||0.15|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 361) = 1.904, p = .150||||||.150
71745141|NCT03863509|143001461|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 385) = 17.872, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||< .001
71745142|NCT03863509|143001461|OTHER||Mean Difference (Final Values)|-3.632||||0.003|TWO_SIDED|95.0|-6.019|-1.245|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive E-Cig Users||-1.245|-6.019|0.003
71745143|NCT03863509|143001461|OTHER||Mean Difference (Final Values)|-8.38|||<|0.001|TWO_SIDED|95.0|-11.14|-5.62|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Never Users minus Exclusive Smokers||-5.62|-11.14|<0.001
71745144|NCT03863509|143001461|OTHER||Mean Difference (Final Values)|-4.748||||0.001|TWO_SIDED|95.0|-7.456|-2.04|||ANCOVA post-hoc pairwise group compariso|Age, sex, and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||-2.040|-7.456|0.001
71745145|NCT03863509|143001462|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||< .001
71745146|NCT03863509|143001462|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
71745147|NCT03863509|143001462|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
71745148|NCT03863509|143001462|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
71778350|NCT02612129|143056073|SUPERIORITY||LS Mean Difference|-5.09||||0.0536|TWO_SIDED|95.0|-10.26|0.08|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 6 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||0.08|-10.26|0.0536
71778351|NCT02612129|143056073|SUPERIORITY||LS Mean Difference|-3.03||||0.3785|TWO_SIDED|95.0|-9.9|3.85|||ANCOVA|||"Change from baseline in the NPC-CDB score (modified Stampfer Score) at Month 12 was analyzed using the ANCOVA model. ANCOVA model was fitted with treatment, baseline NPC-CDB total score and use of miglustat as covariates."||3.85|-9.90|0.3785
71778352|NCT02612129|143056074|SUPERIORITY|||||||0.6951|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Better'||||0.6951
71778353|NCT02612129|143056074|SUPERIORITY|||||||0.7542|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 6 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.7542
71778354|NCT02612129|143056074|SUPERIORITY|||||||0.488|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Better'||||0.4880
71778355|NCT02612129|143056074|SUPERIORITY|||||||0.1804|||||||Chi-squared Test|||Percentage of participants with change from baseline at Month 12 in Quality of Life (EQ-5D-Y) being 'Worse'||||0.1804
71665346|NCT01753297|142844753|OTHER|||||||1|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||1.000
71665347|NCT01753297|142844753|OTHER|||||||0.583|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.583
71834576|NCT05644002|143173253|OTHER||Mean Difference (Final Values)|0.184||||0.666|TWO_SIDED|95.0|-0.663|1.031||The threshold for statistical significance was p\<.05|t-test, 2 sided|Levene's test for equal variances was used. If significance is \<.05, equal variances are not assumed and reported results are adjusted accordingly.||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||1.031|-.663|.666
71834577|NCT05644002|143173253|OTHER||t-statistic|0.184|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 73||An independent-samples t-test was conducted to examine differences in post-stress induction mCEQ psychological reward between the PTBT and Control conditions.||||
71834578|NCT05644002|143173253|OTHER||Hedge's g|0.099|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction mCEQ psychological reward between the PTBT and Control conditions.||||
71665348|NCT01753297|142844755|OTHER|||||||0.557|||||||Log Rank|||A two-sided log-rank test was used to compare time to OS between both treatment groups.|1 death occurred in the active surveillance arm and 2 deaths occurred in the triptorelin arm.|||0.557
71665349|NCT01753297|142844758|OTHER|||||||0.525|||||||Log Rank|||A two-sided log-rank test was used to compare PSADT between both treatment groups.|Analysis was based on 9 PSADT events in the active surveillance arm and 6 PSADT events in the triptorelin arm.|||0.525
71778356|NCT02612129|143056075|SUPERIORITY||LS Mean Difference|0.74||||0.371|TWO_SIDED|95.0|-0.92|2.4|||ANCOVA|||Change from baseline in the SARA score at Month 6 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score, and use of miglustat as covariates.||2.40|-0.92|0.3710
71778357|NCT02612129|143056075|SUPERIORITY||LS Mean Difference|0.28||||0.7899|TWO_SIDED|95.0|-1.82|2.37|||ANCOVA|||Change from baseline in the SARA score at Month 12 was measured using an ANCOVA model. ANCOVA model was fitted with treatment, baseline SARA score and use of miglustat as covariates.||2.37|-1.82|0.7899
71778358|NCT02612129|143056076|SUPERIORITY||LS Mean Difference|-10.34||||0.6195|TWO_SIDED|95.0|-53.01|32.33|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||32.33|-53.01|0.6195
71778359|NCT02612129|143056076|SUPERIORITY||LS Mean Difference|-15.87||||0.4693|TWO_SIDED|95.0|-60.73|29.0|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 6 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||29.00|-60.73|0.4693
71778360|NCT02612129|143056076|SUPERIORITY||LS Mean Difference|3.2||||0.7283|TWO_SIDED|95.0|-15.71|22.12|||ANCOVA|||Dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||22.12|-15.71|0.7283
71834579|NCT05644002|143173254|OTHER||β|0.026||||0.73|TWO_SIDED|95.0|-0.358|0.507||The threshold for statistical significance was p\<.05.|Regression, Linear|Coding: Control=0, PTBT=1.||A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress-induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrhythmia at step 1 of the model.||.507|-.358|.73
71834580|NCT05644002|143173254|OTHER||t-statistic|0.345|||||TWO_SIDED||||||Regression, Linear|degrees freedom = (2, 73)|Condition (0=control; 1=PTBT)|A multiple linear regression test was conducted to examine whether the PTBT intervention (versus control) significantly predicted post-stress induction respiratory sinus arrhythmia during smoking, while controlling for average baseline respiratory sinus arrythmia at step 1 of the model.||||
71834581|NCT05644002|143173255|OTHER||Mean Difference (Final Values)|-0.543||||0.001|TWO_SIDED|95.0|-0.772|-0.314||The threshold for statistical significance was p\<.05.|t-test, 2 sided|Levene's test for equal variances was used. If significance is \< .05, equal variances are not assumed and reported results are adjusted accordingly.||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||-.314|-.772|.001
71834582|NCT05644002|143173255|OTHER||t-statistic|-4.739|||||TWO_SIDED||||||t-test, 2 sided|degrees freedom = 66.03||An independent samples t-test was conducted to examine differences in post-stress-induction average puff duration between PTBT and Control conditions.||||
71778361|NCT02612129|143056076|SUPERIORITY||LS Mean Difference|-5.91||||0.7708|TWO_SIDED|95.0|-47.54|35.72|||ANCOVA|||Non-dominant Hand: Change From Baseline in the Nine-Hole Peg Test (9HPT) at Month 12 was measured using an ANCOVA model: ANCOVA models were fitted with treatment, baseline dominant/non-dominant hand 9HPT time (secs), and use of miglustat as covariates||35.72|-47.54|0.7708
71665350|NCT01753297|142844758|OTHER||Hazard Ratio (HR)|1.72||||0.435|TWO_SIDED|95.0|0.44|6.73|||Regression, Cox|||"Comparison between treatment groups: Triptorelin compared to Active surveillance.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||6.73|0.44|0.435
71665351|NCT01753297|142844758|OTHER|||||||0.761|||||||Regression, Cox|||"Country effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.761
71665352|NCT01753297|142844758|OTHER|||||||0.652|||||||Regression, Cox|||"Centre effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.652
71665353|NCT01753297|142844758|OTHER|||||||0.726|||||||Regression, Cox|||"Gleason score effect.~A Cox proportional hazard model was fitted to compute HRs and the corresponding 95% CIs with treatment group, country (China as reference), centre (the largest centre as reference), and Gleason score on prostatectomy specimen (in categories: ≤6 / =7 / ≥8, with ≤6 considered as the reference) as fixed factors."||||0.726
71665354|NCT01931878|142844787|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||t-test, 2 sided|||comparison of mean RLS Scale scores between 21 incoA and 21 saline injections||||0.031
71665355|NCT01931878|142844788|SUPERIORITY_OR_OTHER|||||||0.0088|TWO_SIDED||||||Fisher Exact|||||||0.0088
71665356|NCT01931878|142844789|SUPERIORITY_OR_OTHER|||||||0.0855|TWO_SIDED||||||Fisher Exact|||||||0.0855
71778362|NCT04508335|143056098|EQUIVALENCE|We use 2, one-sided t-tests, each with alpha set at 0.05 to test the composite null hypothesis that the mean difference score (μReia-μCurrent) between the Reia pessary and baseline (current pessary) on the PFDI-20, is greater than 18.3 (H01), the upper equivalence limit, or lower than -18.3 (H02), the lower equivalence limit.||||||0.0021|||||||t-test, 2 sided|||H01: μReia-μCurrent \> 18.3 and H02: μReia-μCurrent \< -18.3. The alternative hypothesis is thus: HA: -18.3 ≤ μReia-μCurrent ≤ 18.3.||||.0021
71778363|NCT04508335|143056100|OTHER|Mean difference of PFIQ scores. A negative difference (Reia pessary - current pessary) indicates that the PFIQ-7 score improved with the Reia pessary.|Mean Difference (Final Values)|-11.9||||0.0192|TWO_SIDED|||||p value adjusted for multiple variables|Wilcoxon (Mann-Whitney)|||PFIQ scores at baseline with subjects using current pessary then after treatment with Reia pessary||||0.0192
71778364|NCT00531934|143056116|SUPERIORITY_OR_OTHER|||||||0.175|||||||Chi-squared|||||||0.175
71665357|NCT00919126|142844806|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.||The dose of propofol adjusted to BSA and maintenance duration was expected to be 4.0 mg/m².min in the control group, 2.8 mg/m².min in one xenon group and 3.0 mg/m².min in the other xenon group. With an expected common standard deviation of 2.0 mg/m².min, a type I error of 0.05 (two-sided) and a power of 0.80, the sample size required to show a statistically significant difference between the three groups was estimated to be 48 patients per group, resulting in a total of 144 randomised patients.||||<0.0001
71665358|NCT00919126|142844806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0256|||<|0.0001|TWO_SIDED|95.0|2.328|3.724||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Medical Air in Oxygen was assessed.|||3.724|2.328|<0.0001
71665359|NCT00919126|142844806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2905|||<|0.0001|TWO_SIDED|95.0|1.57|3.011||Pairwise comparison performed using Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 50% in Oxygen minus Medical Air in Oxygen was assessed.|||3.011|1.570|<0.0001
71665360|NCT00919126|142844806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7351||||0.0365|TWO_SIDED|95.0|0.038|1.432||Pairwise comparison was performed using the Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Xenon 50% in Oxygen was assessed|||1.432|0.038|0.0365
71665361|NCT02032680|142844828|SUPERIORITY|||||||0.3749|||||||Cochran-Armitage Trend Test|||The two treatments were compared to see whether participants in one achieved a higher level on their goals (i.e., the maximum level achieved on the goal).||||0.3749
71665362|NCT00687830|142844840|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71665363|NCT00687830|142844841|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
71778365|NCT00531934|143056119|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)||||<0.001
71778366|NCT00531934|143056125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.763||||0.143|TWO_SIDED|95.0|0.525|1.109|||Log Rank|||||1.109|0.525|0.143
71834583|NCT05644002|143173255|OTHER||Hedge's g|-1.05|||||TWO_SIDED||||||t-test, 2 sided|||An independent-samples t-test was conducted to examine differences in post-stress-induction average puff duration between the PTBT and Control conditions.||||
71778367|NCT00531934|143056128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.769||||0.153|TWO_SIDED|95.0|0.529|1.116|||Log Rank|||||1.116|0.529|0.153
71778368|NCT00531934|143056134|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3||||0.003
71778369|NCT02975336|143056264|SUPERIORITY||Odds Ratio (OR)|1.55||||0.5462|TWO_SIDED|95.0|0.91|2.64|||Regression, Logistic|||||2.64|0.91|0.5462
71665364|NCT00295061|142844868|NON_INFERIORITY_OR_EQUIVALENCE|A total sample size of 20 subjects could demonstrate comparability of an AUC(0-7days) with 90% power up to a standard deviation of 0.288 of the difference in the log scale, expected mean treatment difference of 0 (= ratio of 1), a lower equivalence limit of -0.223 (= log 0.8), upper limit of 0.223 (= log 1.25) and a one-sided alpha of 0.05 (90% CI).|Geometric least square means ratio|1.03||||||90.0|0.97|1.09||||||To compare AUC 0-7 days between the two treatments (Alpha-1 MP vs. Prolastin),natural log-transformed AUC 0-7 days values were analyzed by analysis of variance (ANOVA).||1.09|0.97|
71665365|NCT02604407|142844871|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-8.1|||<|0.001|TWO_SIDED|95.0|-11.7|-4.4|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 12.5 mg and Placebo.|||-4.4|-11.7|<0.001
71745149|NCT03863509|143001463|OTHER|||||||0.199|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 386) = 1.621, p = .199||||||.199
71745150|NCT03863509|143001464|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
71745151|NCT03863509|143001464|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive E-Cig users||1.824|0.733|<0.001
71745152|NCT03863509|143001464|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|age, sex, race covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
71745153|NCT03863509|143001464|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
71745154|NCT03863509|143001465|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 343) = 17.056, p\< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons.|||<0.001
71745155|NCT03863509|143001465|OTHER||Mean Difference (Final Values)|1.279|||<|0.001|TWO_SIDED|95.0|0.733|1.824|||ANCOVA post-hoc pairwise group compariso|Age, sex, race were covaried||Never Users minus Exclusive E-Cig Users||1.824|0.733|<0.001
71778370|NCT02975336|143056264|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5462|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||||2.18|0.76|0.5462
71778371|NCT02975336|143056264|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5462|TWO_SIDED|95.0|0.67|1.93|||Regression, Logistic|||||1.93|0.67|0.5462
71778372|NCT02975336|143056265|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5462|TWO_SIDED|95.0|0.69|3.24|||Regression, Logistic|||||3.24|0.69|0.5462
71665366|NCT02604407|142844871|SUPERIORITY_OR_OTHER_LEGACY||Difference of LS Mean|-13.4|||<|0.001|TWO_SIDED|95.0|-17.1|-9.7|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 37.5 mg and Placebo.|||-9.7|-17.1|<0.001
71745156|NCT03863509|143001465|OTHER||Mean Difference (Final Values)|1.739|||<|0.001|TWO_SIDED|95.0|1.083|2.395|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Never Users minus Exclusive Smokers||2.395|1.083|<0.001
71745157|NCT03863509|143001465|OTHER||Mean Difference (Final Values)|0.46||||0.165|TWO_SIDED|95.0|-0.19|1.11|||ANCOVA post-hoc pairwise group compariso|Age, sex and race were covaried||Exclusive E-Cig Users minus Exclusive Smokers||1.110|-0.190|0.165
71745158|NCT03863509|143001466|OTHER||||||<|0.001|||||||ANCOVA|Age, sex, and race/ethnicity were covaried. Test for group difference: F (2, 344) = 10.075, p \< .001|||Group difference tested for false discovery rate at .05, and followed with post-hoc pairwise comparisons. Estimated marginal mean differences:|||<0.001
71745159|NCT04970654|143001467|NON_INFERIORITY|Non-inferiority was considered confirmed if the lower bound of the 95% confidence interval was higher than the margin of -2.0 cm/year.|Treatment difference|0.6|||||TWO_SIDED|95.0|-0.2|1.3||||||Hypothetical strategy estimand. Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, growth hormone (GH) peak group and gender by age group interaction term as factors and baseline height as a covariate, all nested within week as a factor.||1.3|-0.2|
71745160|NCT06172348|143001484|OTHER||Ratio of Adjusted Geometric Means|21.89|||||TWO_SIDED|90.0|19.31|24.8|||||Ratios (Test/Reference) and 90 percent (%) confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||24.80|19.31|
71745161|NCT06172348|143001484|OTHER||Ratio of Adjusted Geometric Means|12.65|||||TWO_SIDED|90.0|11.21|14.27|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||14.27|11.21|
71745162|NCT06172348|143001485|OTHER||Ratio of Adjusted Geometric Means|86.49|||||TWO_SIDED|90.0|79.11|94.54|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||94.54|79.11|
71745163|NCT06172348|143001485|OTHER||Ratio of Adjusted Geometric Means|76.99|||||TWO_SIDED|90.0|70.65|83.9|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule; Reference = Oral solution.|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||83.90|70.65|
71778373|NCT02975336|143056265|SUPERIORITY||Odds Ratio (OR)|1.42||||0.5462|TWO_SIDED|95.0|0.68|2.97|||Regression, Logistic|||||2.97|0.68|0.5462
71778374|NCT02975336|143056265|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5462|TWO_SIDED|95.0|0.59|2.75|||Regression, Logistic|||||2.75|0.59|0.5462
71778375|NCT02975336|143056293|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.7034|TWO_SIDED|95.0|0.57|2.4|||Cox proportional hazards model|||||2.40|0.57|0.7034
71778376|NCT02975336|143056293|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.5462|TWO_SIDED|95.0|0.31|1.52|||Cox proportional hazards model|||||1.52|0.31|0.5462
71778377|NCT02975336|143056293|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5462|TWO_SIDED|95.0|0.42|1.97|||Cox proportional hazards model|||||1.97|0.42|0.5462
71778378|NCT02975336|143056294|SUPERIORITY||Odds Ratio (OR)|1.52||||0.5462|TWO_SIDED|95.0|0.74|3.15|||Regression, Logistic|||||3.15|0.74|0.5462
71745164|NCT06172348|143001486|OTHER||Ratio of Adjusted Geometric Means|123.92|||||TWO_SIDED|90.0|105.16|146.02|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||146.02|105.16|
71745165|NCT06172348|143001486|OTHER||Ratio of Adjusted Geometric Means|129.79|||||TWO_SIDED|90.0|111.51|151.06|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||151.06|111.51|
71745166|NCT06172348|143001487|OTHER||Ratio of Adjusted Geometric Means|107.48|||||TWO_SIDED|90.0|96.46|119.76|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR1 capsule (fed); Reference = MR1 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||119.76|96.46|
71778379|NCT02975336|143056294|SUPERIORITY||Odds Ratio (OR)|1.03||||0.5462|TWO_SIDED|95.0|0.49|2.13|||Regression, Logistic|||||2.13|0.49|0.5462
71778380|NCT02975336|143056294|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5462|TWO_SIDED|95.0|0.65|2.81|||Regression, Logistic|||||2.81|0.65|0.5462
71778381|NCT02975336|143056295|SUPERIORITY||Odds Ratio (OR)|1.6||||0.2434|TWO_SIDED|95.0|0.73|3.54|||Regression, Logistic|||||3.54|0.73|0.2434
71778382|NCT02975336|143056295|SUPERIORITY||Odds Ratio (OR)|1.62||||0.2389|TWO_SIDED|95.0|0.73|3.63|||Regression, Logistic|||||3.63|0.73|0.2389
71665367|NCT03417778|142844873|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|161.14|||||TWO_SIDED|90.0|80.77|321.48||||||An analysis of variance (ANOVA) model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% confidence intervals (CI) were calculated for the geometric least-squares mean (GLSM) ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||321.48|80.77|
71665368|NCT03417778|142844874|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUClast of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUClast change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.08|||||TWO_SIDED|90.0|69.67|213.89||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUClast. Two-sided 90% CI were calculated for the GLSM ratio of AUClast between hepatic impairment group versus the matched control (normal hepatic function) group.||213.89|69.67|
71778383|NCT02975336|143056295|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1952|TWO_SIDED|95.0|0.76|3.85|||Regression, Logistic|||||3.85|0.76|0.1952
71834584|NCT02652260|143173305|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|4.65||||0.331|TWO_SIDED|95.0|-15.92|24.85|||Miettinen and Nurminen|||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.|24.85|-15.92|0.331
71745167|NCT06172348|143001487|OTHER||Ratio of Adjusted Geometric Means|109.63|||||TWO_SIDED|90.0|99.19|121.17|||||Ratios (Test/Reference) and 90% confidence intervals were expressed as percentages. Test = MR2 capsule (fed); Reference = MR2 capsule (fasted).|A mixed effect model was used with sequence, period and treatment as fixed effects and participant with sequence as a random effect.||121.17|99.19|
71778384|NCT02975336|143056296|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.0987|TWO_SIDED|95.0|0.87|2.89|||Cox proportional hazards model|||||2.89|0.87|0.0987
71834585|NCT02652260|143173306|OTHER|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|-18.61|||||TWO_SIDED|95.0|-38.14|2.51||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|2.51|-38.14|
71745168|NCT05579977|143001545|OTHER||LS Mean Difference|-0.95|||<|0.0001|TWO_SIDED|90.0|-1.2|-0.7|||Mixed Models Analysis|||||-0.70|-1.20|<.0001
71745169|NCT05579977|143001545|OTHER||LS Mean Difference|-1.3|||<|0.0001|TWO_SIDED|90.0|-1.55|-1.04|||Mixed Models Analysis|||||-1.04|-1.55|<.0001
71745170|NCT05579977|143001545|OTHER||LS Mean Difference|-1.37|||<|0.0001||90.0|-1.62|-1.11|||Mixed Models Analysis|||||-1.11|-1.62|<.0001
71745171|NCT05579977|143001545|OTHER||LS Mean Difference|-1.26|||<|0.0001|TWO_SIDED|90.0|-1.52|-1.01|||Mixed Models Analysis|||||-1.01|-1.52|<.0001
71745172|NCT05579977|143001545|OTHER||LS Mean Difference|-1.29|||<|0.0001||90.0|-1.55|-1.03|||Mixed Models Analysis|||||-1.03|-1.55|<.0001
71745173|NCT05579977|143001545|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
71745174|NCT05579977|143001546|OTHER||LS Mean Difference|-2.44||||0.0055|TWO_SIDED|90.0|-3.88|-1.0|||Mixed Models Analysis|||||-1.00|-3.88|0.0055
71778385|NCT02975336|143056296|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9201|TWO_SIDED|95.0|0.51|1.85|||Cox proportional hazards model|||||1.85|0.51|0.9201
71778386|NCT02975336|143056296|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.5645|TWO_SIDED|95.0|0.6|2.2|||Cox proportional hazards model|||||2.20|0.60|0.5645
71778387|NCT02975336|143056297|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3743|TWO_SIDED|95.0|0.44|1.37|||Regression, Logistic|||||1.37|0.44|0.3743
71778388|NCT02975336|143056297|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6445|TWO_SIDED|95.0|0.5|1.54|||Regression, Logistic|||||1.54|0.50|0.6445
71778389|NCT02975336|143056297|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2634|TWO_SIDED|95.0|0.41|1.28|||Regression, Logistic|||||1.28|0.41|0.2634
71778390|NCT02975336|143056298|SUPERIORITY||Rate Ratio|1.59||||0.2989|TWO_SIDED|95.0|0.66|3.81||Nominal p-value|Negative binomial regression|||||3.81|0.66|0.2989
71778391|NCT02975336|143056298|SUPERIORITY||Rate Ratio|0.85||||0.7325|TWO_SIDED|95.0|0.33|2.19||Nominal p-value|Negative binomial regression|||||2.19|0.33|0.7325
71778392|NCT02975336|143056298|SUPERIORITY||Rate Ratio|1.29||||0.591|TWO_SIDED|95.0|0.51|3.22||Nominal p-value|Negative binomial regression|||||3.22|0.51|0.5910
71778393|NCT02975336|143056299|SUPERIORITY||Odds Ratio (OR)|1.33||||0.3635|TWO_SIDED|95.0|0.72|2.47|||Regression, Logistic|||||2.47|0.72|0.3635
71778394|NCT02975336|143056299|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0329|TWO_SIDED|95.0|1.06|3.56|||Regression, Logistic|||||3.56|1.06|0.0329
71778395|NCT02975336|143056299|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7619|TWO_SIDED|95.0|0.59|2.07|||Regression, Logistic|||||2.07|0.59|0.7619
71778396|NCT02975336|143056300|SUPERIORITY||Odds Ratio (OR)|1.36||||0.2642|TWO_SIDED|95.0|0.79|2.35|||Regression, Logistic|||||2.35|0.79|0.2642
71778397|NCT02975336|143056300|SUPERIORITY||Odds Ratio (OR)|1.49||||0.1489|TWO_SIDED|95.0|0.87|2.57|||Regression, Logistic|||||2.57|0.87|0.1489
71778398|NCT02975336|143056300|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9285|TWO_SIDED|95.0|0.56|1.7|||Regression, Logistic|||||1.70|0.56|0.9285
71778399|NCT02975336|143056303|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9061|TWO_SIDED|95.0|0.49|1.88|||Regression, Logistic|||||1.88|0.49|0.9061
71778400|NCT02975336|143056303|SUPERIORITY||Odds Ratio (OR)|1.19||||0.6053|TWO_SIDED|95.0|0.61|2.31|||Regression, Logistic|||||2.31|0.61|0.6053
71778401|NCT02975336|143056303|SUPERIORITY||Odds Ratio (OR)|0.8||||0.52|TWO_SIDED|95.0|0.4|1.59|||Regression, Logistic|||||1.59|0.40|0.5200
71778402|NCT02975336|143056312|SUPERIORITY||Rate difference|5.9|||||TWO_SIDED|95.0|-9.7|21.2||||||||21.2|-9.7|
71778403|NCT02975336|143056312|SUPERIORITY||Rate Difference|0.6|||||TWO_SIDED|95.0|-14.5|15.6||||||||15.6|-14.5|
71778404|NCT02975336|143056312|SUPERIORITY||Rate difference|1.6|||||TWO_SIDED|95.0|-13.5|16.6||||||||16.6|-13.5|
71778405|NCT02975336|143056316|SUPERIORITY||Odds Ratio (OR)|1.14||||0.7728|TWO_SIDED|95.0|0.46|2.82|||Regression, Logistic|||||2.82|0.46|0.7728
71778406|NCT02975336|143056316|SUPERIORITY||Odds Ratio (OR)|0.66||||0.3314|TWO_SIDED|95.0|0.28|1.54|||Regression, Logistic|||||1.54|0.28|0.3314
71778407|NCT02975336|143056316|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7205|TWO_SIDED|95.0|0.36|2.04|||Regression, Logistic|||||2.04|0.36|0.7205
71834586|NCT02652260|143173307|OTHER||Estimated Difference|-2.0|||||TWO_SIDED|95.0|-10.5|6.5||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was based on a t-distribution.|6.5|-10.5|
71834587|NCT02652260|143173308|OTHER||Estimated Difference|3.6|||||TWO_SIDED|95.0|-4.1|11.3||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.|11.3|-4.1|
71778408|NCT02975336|143056317|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8364|TWO_SIDED|95.0|0.35|3.71|||Regression, Logistic|||||3.71|0.35|0.8364
71778409|NCT02975336|143056317|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8287|TWO_SIDED|95.0|0.37|3.45|||Regression, Logistic|||||3.45|0.37|0.8287
71778410|NCT02975336|143056317|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7621|TWO_SIDED|95.0|0.35|4.16|||Regression, Logistic|||||4.16|0.35|0.7621
71778411|NCT02975336|143056318|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8464|TWO_SIDED|95.0|0.23|3.31|||Regression, Logistic|||||3.31|0.23|0.8464
71778412|NCT02975336|143056318|SUPERIORITY||Odds Ratio (OR)|0.59||||0.417|TWO_SIDED|95.0|0.16|2.12|||Regression, Logistic|||||2.12|0.16|0.4170
71778413|NCT02975336|143056318|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9988|TWO_SIDED|95.0|0.27|3.74|||Regression, Logistic|||||3.74|0.27|0.9988
71778414|NCT02975336|143056319|SUPERIORITY||Odds Ratio (OR)|1.13||||0.697|TWO_SIDED|95.0|0.62|2.04|||Regression, Logistic|||||2.04|0.62|0.6970
71778415|NCT02975336|143056319|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3234|TWO_SIDED|95.0|0.75|2.42|||Regression, Logistic|||||2.42|0.75|0.3234
71778416|NCT02975336|143056319|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9846|TWO_SIDED|95.0|0.54|1.82|||Regression, Logistic|||||1.82|0.54|0.9846
71778417|NCT03792191|143056322|SUPERIORITY||Median Difference (Final Values)|0.00007||||0.62|TWO_SIDED|95.0|-0.00005|1.0|||Wilcoxon (Mann-Whitney)|||||1|-0.00005|0.62
71778418|NCT03792191|143056323|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71778419|NCT03792191|143056324|SUPERIORITY||Risk Difference (RD)|-0.036||||0.6|TWO_SIDED|95.0|-0.15|0.079|||Chi-squared, Corrected|||||0.079|-0.15|0.6
71778420|NCT03792191|143056325|SUPERIORITY||Risk Difference (RD)|-0.021||||0.77|TWO_SIDED|95.0|-0.125|0.082|||Chi-squared, Corrected|||||0.082|-0.125|0.77
71778421|NCT03792191|143056326|SUPERIORITY||Median Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-1|0.077
71778422|NCT03792191|143056327|SUPERIORITY||Median Difference (Final Values)|0.00003||||0.1|TWO_SIDED|95.0|-0.00001|0.00003|||Wilcoxon (Mann-Whitney)|||||0.00003|-0.00001|0.1
71778423|NCT03792191|143056328|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
71778424|NCT03792191|143056329|SUPERIORITY||||||>|0.99|||||||Chi-squared, Corrected|||||||>0.99
71778425|NCT03792191|143056331|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71778426|NCT03917459|143056372|OTHER||LS mean of treatment difference|2.9|STANDARD_ERROR_OF_MEAN|2.94||0.3432|TWO_SIDED|95.0|-3.29|9.01|||Mixed Model Repeated Measures (MMRM)|||||9.01|-3.29|0.3432
71778427|NCT00491764|143056375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9||||0.005||95.0|8.9|36.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||36.8|8.9|0.005
71778428|NCT00491764|143056375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.1|||<|0.001||95.0|38.0|70.1|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.1|38.0|<0.001
71778429|NCT00491764|143056375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.5|||<|0.001||95.0|28.5|62.4|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||62.4|28.5|<0.001
71778430|NCT00491764|143056375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.012||95.0|6.7|33.3|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||33.3|6.7|0.012
71778431|NCT00491764|143056375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.1|||<|0.001||95.0|21.1|53.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||53.2|21.1|<0.001
71778432|NCT00491764|143056376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.7||||0.002||95.0|11.2|40.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||40.2|11.2|0.002
71778433|NCT00491764|143056376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
71745175|NCT05579977|143001546|OTHER||LS Mean Difference|-4.37|||<|0.0001|TWO_SIDED|90.0|-5.84|-2.89|||Mixed Models Analysis|||||-2.89|-5.84|<.0001
71745176|NCT05579977|143001546|OTHER||LS Mean Difference|-5.63|||<|0.0001|TWO_SIDED|90.0|-7.07|-4.18|||Mixed Models Analysis|||||-4.18|-7.07|<.0001
71745177|NCT05579977|143001546|OTHER||LS Mean Difference|-5.04|||<|0.0001|TWO_SIDED|90.0|-6.5|-3.58|||Mixed Models Analysis|||||-3.58|-6.50|<.0001
71745178|NCT05579977|143001546|OTHER||LS Mean Difference|-5.42|||<|0.0001|TWO_SIDED|90.0|-6.91|-3.93|||Mixed Models Analysis|||||-3.93|-6.91|<.0001
71745179|NCT05579977|143001549|OTHER||LS Mean Difference|-0.86|||<|0.0001|TWO_SIDED|90.0|-1.12|-0.61|||Mixed Models Analysis|||||-0.61|-1.12|<.0001
71745180|NCT01420926|143001556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Stratified 1-sided log-rank|||||||0.30
71834588|NCT02652260|143173309|OTHER|The 95% CI was calculated by the method of Miettinen and Nurminen.|Difference in Percentage|-38.4|||||TWO_SIDED|95.0|-51.2|-23.8||||||Change from time of switch to 24 weeks post-switch: Treatment difference in percent response|Week 24 Post-switch minus Time of switch|-23.8|-51.2|
71745181|NCT00932321|143001562|NON_INFERIORITY_OR_EQUIVALENCE|Primary hypothesis tested was the independence (lack of association) of mean number of IB days in Cycles 2-6 across treatment groups.||||||0.311|||||||Cochran-Mantel-Haenszel|Stratified by investigational site.||||||0.311
71745182|NCT02775916|143001564|SUPERIORITY||Mean Difference (Net)|-0.69|STANDARD_DEVIATION|1.332|||TWO_SIDED|95.0|-3.343|1.937||||||||1.937|-3.343|
71778434|NCT00491764|143056376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|48.5|||<|0.001||95.0|31.4|65.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||65.5|31.4|<0.001
71778435|NCT00491764|143056376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
71778436|NCT00491764|143056376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|54.3|||<|0.001||95.0|37.8|70.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||70.8|37.8|<0.001
71778437|NCT00491764|143056377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
71834589|NCT02652260|143173310|OTHER|The 95% CI was based on a t-distribution.|Mean Difference (Final Values)|-13.4|||||TWO_SIDED|95.0|-16.8|-10.1||||||Change from time of switch to 24 weeks post-switch: Treatment difference in score|Week 24 Post-switch minus Time of switch|-10.1|-16.8|
71745183|NCT02775916|143001565|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-2.52|3.55||||||||3.55|-2.52|
71745184|NCT02775916|143001566|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.119|||TWO_SIDED|95.0|-6.08|6.89||||||||6.89|-6.08|
71745185|NCT02775916|143001566|SUPERIORITY||Mean Difference (Net)|4.33|STANDARD_ERROR_OF_MEAN|4.615|||TWO_SIDED|95.0|-5.27|13.93||||||||13.93|-5.27|
71745186|NCT02775916|143001567|SUPERIORITY||Mean Difference (Net)|-6.55|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|-21.76|8.66||||||||8.66|-21.76|
71745187|NCT02775916|143001568|SUPERIORITY||Mean Difference (Net)|-10.97|STANDARD_ERROR_OF_MEAN|9.626|||TWO_SIDED|95.0|-30.94|9.0||||||||9.00|-30.94|
71745188|NCT02775916|143001569|SUPERIORITY||Mean Difference (Net)|-7.69|STANDARD_ERROR_OF_MEAN|10.595|||TWO_SIDED|95.0|-29.75|14.37||||||||14.37|-29.75|
71745189|NCT00865345|143001578|SUPERIORITY_OR_OTHER||Intercept from ANCOVA model|70.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.05|TWO_SIDED|95.0|60.0|100.0|||ANCOVA|null model ANOVA is used to calculate 95% CI around accuracy rate. Intercept was fit in the abscence of other predictors.||||100|60|<0.05
71745190|NCT02723773|143001584|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.77|||||TWO_SIDED|95.0|73.72|84.61|||Poisson regression method||VE=1 - the relative risk (RR). RR=the ratio of the incidence rates of LTFU+Control \>=50YOA Group over Historical Control \>=50YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||84.61|73.72|
71745191|NCT02723773|143001585|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|75.55|93.36|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||93.36|75.55|
71745192|NCT02723773|143001585|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.14|||||TWO_SIDED|95.0|74.17|94.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||94.35|74.17|
71745193|NCT02723773|143001585|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|77.11|||||TWO_SIDED|95.0|69.37|83.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||83.14|69.37|
71778438|NCT00491764|143056377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||80.2|49.5|<0.001
71778439|NCT00491764|143056377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||<|0.001||95.0|50.6|82.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||82.8|50.6|<0.001
71778440|NCT00491764|143056377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||46.8|16.0|<0.001
71665369|NCT03417778|142844875|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|159.15|||||TWO_SIDED|90.0|82.22|308.06||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||308.06|82.22|
71834590|NCT02652260|143173311|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-9.02|||||TWO_SIDED|95.0|-15.69|-2.35||||||Difference Estimate: LDL Cholesterol|ISG minus DSG|-2.35|-15.69|
71834591|NCT02652260|143173311|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-13.57|||||TWO_SIDED|95.0|-20.79|-6.35||||||Difference Estimate: Non-HDL Cholesterol|ISG minus DSG|-6.35|-20.79|
71834592|NCT02652260|143173311|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-21.42|||||TWO_SIDED|95.0|-29.63|-13.21||||||Difference Estimate: Cholesterol|ISG minus DSG|-13.21|-29.63|
71834593|NCT02652260|143173311|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-8.18|||||TWO_SIDED|95.0|-11.76|-4.6||||||Difference Estimate: HDL Cholesterol|ISG minus DSG|-4.60|-11.76|
71834594|NCT02652260|143173311|OTHER|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-22.18|||||TWO_SIDED|95.0|-38.52|-5.84||||||Difference Estimate: Triglyceride|ISG minus DSG|-5.84|-38.52|
71834595|NCT03899961|143173325|SUPERIORITY|Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median Difference (Net)|0.0||||0.05|TWO_SIDED|95.0|-1.09|1.09||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval|Median regression model for the change f|||Median regression model for the change from baseline, model was adjusted for treatment, bootstrap was used for the confidence interval||1.09|-1.09|0.05
71834596|NCT03494504|143173485|SUPERIORITY||Odds Ratio (OR)|2.36|||||TWO_SIDED|95.0|1.46|3.84||||||||3.84|1.46|
71834597|NCT03494504|143173485|SUPERIORITY||Odds Ratio (OR)|1.81|||||TWO_SIDED|95.0|1.11|2.94||||||||2.94|1.11|
71834598|NCT03517553|143173503|SUPERIORITY|||||||0.999||||||Threshold for statistical significance is P\<0.05|Kruskal-Wallis|||||||0.999
71778441|NCT00491764|143056377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.1|||<|0.001||95.0|40.7|73.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.|||73.5|40.7|<0.001
71778442|NCT01479478|143056378|SUPERIORITY|||||||0.87|||||||Cochran-Mantel-Haenszel|||||||0.87
71834599|NCT03517553|143173503|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
71834600|NCT03517553|143173504|SUPERIORITY|||||||0.869|||||||Kruskal-Wallis|||||||0.869
71834601|NCT03517553|143173504|SUPERIORITY|||||||0.813|||||||Kruskal-Wallis|||||||0.813
71834602|NCT03517553|143173504|SUPERIORITY|||||||0.978|||||||Kruskal-Wallis|||||||0.978
71834603|NCT03517553|143173504|SUPERIORITY|||||||0.731|||||||Kruskal-Wallis|||||||0.731
71834604|NCT03517553|143173504|SUPERIORITY|||||||0.703|||||||Kruskal-Wallis|||||||0.703
71834605|NCT03517553|143173504|SUPERIORITY|||||||0.909|||||||Kruskal-Wallis|||||||0.909
71834606|NCT01046136|143173586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0096|||||||Regression, Logistic|p-value is from a logistic regression model with terms for treatment group and center||Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.||||0.0096
71834607|NCT01046136|143173588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|||||||Wilcoxon (Mann-Whitney)|P-value is from a Wilcoxon rank sum test comparing the two treatment groups.||||||0.0293
71834608|NCT00818246|143173632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
71778443|NCT01188421|143056411|SUPERIORITY||F-value for main effect of Group|1.31||||0.275|TWO_SIDED|||||Main effect of Group (e.g., Buprenorphine, Tramadol, Clonidine) on COWS Total Score Ratings|ANOVA|||A power analysis determined 40 participants in each group would detect a moderate effect size, assuming an alpha of 0.05 and 80% power. Due to the expiration of buprenorphine tablets, recruitment was terminated after enrolling 103 participants. This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.||||.275
71778444|NCT01188421|143056411|SUPERIORITY||F-value for main effect of Phase|3.57||||0.03|TWO_SIDED|||||Main effect for Phase (e.g., Stabilization, Taper, Post-Taper) on COWS total score.|ANOVA|||||||0.03
71834609|NCT00818246|143173633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|||||||ANCOVA|||||||<0.001
71890987|NCT01157117|143304005|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.0||||0.42|TWO_SIDED|95.0|-13.4|37.3||No adjustments were made to the p-value.|Fisher Exact|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher's Exact test with the null hypothesis that there was no difference between treatment groups.||37.3|-13.4|0.42
71665370|NCT03417778|142844876|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for AUCinf of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit AUCinf change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|122.32|||||TWO_SIDED|90.0|69.9|214.07||||||An ANOVA model was fitted to the natural logarithmic transformed values of the AUCinf. Two-sided 90% CI were calculated for the GLSM ratio of AUCinf between hepatic impairment group versus the matched control (normal hepatic function) group.||214.07|69.90|
71745194|NCT02723773|143001585|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.18|||||TWO_SIDED|95.0|62.94|80.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||80.92|62.94|
71745195|NCT02723773|143001586|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.73|||||TWO_SIDED|95.0|84.89|90.12|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control 50 YOA Group.||90.12|84.89|
71745196|NCT02723773|143001586|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.74|||||TWO_SIDED|95.0|86.25|95.37|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||95.37|86.25|
71745197|NCT02723773|143001586|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.57|||||TWO_SIDED|95.0|86.66|96.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||96.24|86.66|
71745198|NCT02723773|143001586|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.45|||||TWO_SIDED|95.0|82.98|89.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||89.33|82.98|
71745199|NCT02723773|143001586|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.33|||||TWO_SIDED|95.0|79.91|87.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||87.93|79.91|
71745200|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.68|||||TWO_SIDED|95.0|93.07|99.53|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 1.||99.53|93.07|
71778445|NCT01188421|143056411|SUPERIORITY||F-value for the main effect of Group x P|2.03||||0.092|TWO_SIDED|||||Main effect for Group x Phase interaction on COWS Total Score|ANOVA|||||||0.092
71778446|NCT00075218|143056412|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.329|||<|0.001||95.0|0.233|0.466||The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O'Brien-Fleming stopping rule.|Log Rank|two-sided unstratified log-rank test||The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.||0.466|0.233|<0.001
71778447|NCT00075218|143056413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.347|||<|0.001||95.0|0.253|0.475||No p-value adjustment for multiple comparisons.|Log Rank|||||0.475|0.253|<0.001
71745201|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|96.76|||||TWO_SIDED|95.0|80.57|99.92|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 1.||99.92|80.57|
71745202|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|79.32|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 1.||100.00|79.32|
71778448|NCT00075218|143056415|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.876||||0.306||95.0|0.679|1.129||No p-value adjustment for multiple comparisons.|Log Rank|||||1.129|0.679|0.306
71778449|NCT00075218|143056416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.505||||0.306||95.0|0.262|1.134||No p-value adjustment for multiple comparisons.|Rank Preserving Structural Failure Time||95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.|||1.134|0.262|0.306
71778450|NCT00075218|143056418|SUPERIORITY_OR_OTHER||rate (percentage)|6.6||||||95.0|3.8|10.5|||||Used exact method based on binomial distribution.|||10.5|3.8|
71778451|NCT00075218|143056418|SUPERIORITY_OR_OTHER||Treatment Difference (%)|6.58||||0.004||95.0|3.47|9.7||No p-value adjustment for multiple comparisons.|Pearson chi-square test|||||9.70|3.47|0.004
71778452|NCT00075218|143056421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.339|||<|0.001||95.0|0.244|0.472||two-sided unstratified log-rank test|Log Rank|||||0.472|0.244|<0.001
71778453|NCT00075218|143056421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.327|||<|0.001||95.0|0.232|0.46|||Log Rank|log-rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score||Stratified log-rank test||0.460|0.232|<0.001
71778454|NCT00075218|143056422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.972||||0.9322||95.0|0.508|1.86|||Log Rank|2-sided, unstratified log-rank test||||1.860|0.508|0.9322
71778455|NCT00075218|143056423|SUPERIORITY_OR_OTHER||Treatment Difference (percent)|17.3||||0.0046||95.0|6.7|28.0|||Pearson chi-square||95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)\*100.|||28.0|6.7|0.0046
71745203|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.97|||||TWO_SIDED|95.0|92.46|99.76|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 1.||99.76|92.46|
71745204|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|97.57|||||TWO_SIDED|95.0|90.96|99.71|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 1.||99.71|90.96|
71745205|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.69|||||TWO_SIDED|95.0|86.15|96.57|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 2.||96.57|86.15|
71745206|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.66|||||TWO_SIDED|95.0|70.78|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 2.||99.15|70.78|
71745207|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|95.49|||||TWO_SIDED|95.0|72.11|99.89|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 2.||99.89|72.11|
71778456|NCT02387710|143056456|OTHER||||||>|0.5|||||||Wilcoxon (Mann-Whitney)|||||||>0.5
71778457|NCT01967173|143056483|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.003
71778458|NCT01967173|143056483|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250||||0.9
71778459|NCT01967173|143056483|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500||||<0.001
71778460|NCT01967173|143056483|SUPERIORITY|||||||0.42|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.42
71778461|NCT01967173|143056483|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50||||0.84
71778462|NCT01967173|143056483|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500||||0.015
71778463|NCT01967173|143056483|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.085
71778464|NCT01967173|143056483|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250||||0.62
71665371|NCT03417778|142844877|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of filgotinib falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for filgotinib compared with participants with normal liver function will be rejected.|GLSM Ratio|115.98|||||TWO_SIDED|90.0|58.75|228.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||228.98|58.75|
71665372|NCT03417778|142844878|OTHER|If the upper bound of the 2-sided 90% CIs of the GLSM ratio for Cmax of GS-829845 falls within the \[50%, 200%\] bound, the null hypothesis that participants with hepatic impairment exhibit Cmax change of at least 2-fold for GS-829845 compared with participants with normal liver function will be rejected.|GLSM Ratio|102.85|||||TWO_SIDED|90.0|60.12|175.98||||||An ANOVA model was fitted to the natural logarithmic transformed values of the Cmax. Two-sided 90% CI were calculated for the GLSM ratio of Cmax between hepatic impairment group versus the matched control (normal hepatic function) group.||175.98|60.12|
71665373|NCT03852537|142844919|SUPERIORITY|||||||0.494|||||||Fisher Exact|||||||0.494
71665374|NCT03852537|142844920|SUPERIORITY|||||||0.666|||||||Fisher Exact|||||||0.666
71665375|NCT03852537|142844921|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71665376|NCT03852537|142844923|SUPERIORITY|||||||0.477|||||||Fisher Exact|||||||0.477
71665377|NCT03852537|142844924|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
71665378|NCT03852537|142844925|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71665379|NCT03852537|142844926|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71665380|NCT03852537|142844927|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71665381|NCT03852537|142844929|SUPERIORITY|||||||0.213|||||||Chi-squared|||||||0.213
71665382|NCT05199090|142844975|OTHER||adjusted means|-1.9||||0.0182|TWO_SIDED|80.0|-2.9|-0.9|||MMRM analysis|||Comparison of adjusted means||-0.9|-2.9|0.0182
71665383|NCT05199090|142844975|OTHER||adjusted means|-1.3||||0.1205|TWO_SIDED|80.0|-2.4|-0.2|||MMRM analysis|||||-0.2|-2.4|0.1205
71665384|NCT05199090|142844975|OTHER||adjusted means|-1.3||||0.0931|TWO_SIDED|80.0|-2.2|-0.3|||MMRM analysis|||||-0.3|-2.2|0.0931
71665385|NCT05199090|142844975|OTHER||adjusted means|0.6||||0.4994|TWO_SIDED|80.0|-0.5|1.7|||MMRM analysis|||||1.7|-0.5|0.4994
71665386|NCT05199090|142844975|OTHER||adjusted means|1.0||||0.2295|TWO_SIDED|80.0|-0.1|2.1|||MMRM analysis|||||2.1|-0.1|0.2295
71665387|NCT05199090|142844975|OTHER||adjusted means|-0.7||||0.2114|TWO_SIDED|80.0|-1.3|0.0|||MMRM analysis|||||0.0|-1.3|0.2114
71665388|NCT04873934|142844981|SUPERIORITY||LS mean difference|-46.9|||<|0.001|TWO_SIDED|97.5|-55.4|-38.5|||Mixed Models Analysis|||||-38.5|-55.4|< 0.001
71665389|NCT04873934|142844982|SUPERIORITY||Odds Ratio (OR)|5.42|||<|0.001|TWO_SIDED|97.5|3.29|8.91|||Regression, Logistic|||||8.91|3.29|< 0.001
71665390|NCT04873934|142844983|SUPERIORITY||LS mean difference|-42.0|||<|0.001|TWO_SIDED|95.0|-47.3|-36.7|||Mixed Models Analysis|||Day 90||-36.7|-47.3|< 0.001
71665391|NCT04873934|142844983|SUPERIORITY||LS mean difference|-30.8|||<|0.001|TWO_SIDED|95.0|-37.4|-24.3|||Mixed Models Analysis|||Day 270||-24.3|-37.4|< 0.001
71665392|NCT04873934|142844983|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.5|-31.0|||Mixed Models Analysis|||Day 330||-31.0|-44.5|< 0.001
71665393|NCT04873934|142844984|SUPERIORITY||LS mean difference|-46.7|||<|0.001|TWO_SIDED|95.0|-52.7|-40.8|||ANCOVA|||||-40.8|-52.7|< 0.001
71665394|NCT04873934|142844985|SUPERIORITY||LS mean difference|-37.3|||<|0.001|TWO_SIDED|95.0|-42.4|-32.2|||ANCOVA|||||-32.2|-42.4|< 0.001
71665395|NCT04873934|142844986|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|6.33|22.25|||Regression, Logistic|||||22.25|6.33|< 0.001
71665396|NCT04873934|142844987|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|1.92|9.99|||Regression, Logistic|||Achieving LDL-C \< 100 mg/dL||9.99|1.92|< 0.001
71665397|NCT04873934|142844987|SUPERIORITY||Odds Ratio (OR)|8.24|||<|0.001|TWO_SIDED|95.0|4.97|13.65|||Regression, Logistic|||Achieving LDL-C \< 55 mg/dL||13.65|4.97|< 0.001
71665398|NCT04873934|142844988|SUPERIORITY||LS mean difference|-37.5|||<|0.001|TWO_SIDED|95.0|-44.8|-30.3|||Mixed Models Analysis|||Apolipoprotein B||-30.3|-44.8|< 0.001
71665399|NCT04873934|142844988|SUPERIORITY||LS mean difference|-6.4||||0.188|TWO_SIDED|95.0|-16.0|3.1|||Mixed Models Analysis|||VLDL Cholesterol||3.1|-16.0|0.188
71665400|NCT04873934|142844988|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-44.0|-31.4|||Mixed Models Analysis|||Non-HDL Cholesterol||-31.4|-44.0|< 0.001
71665401|NCT04873934|142844988|SUPERIORITY||LS mean difference|-25.5|||<|0.001|TWO_SIDED|95.0|-30.2|-20.7|||Mixed Models Analysis|||Total Cholesterol||-20.7|-30.2|< 0.001
71665402|NCT04873934|142844988|SUPERIORITY||LS mean difference|-16.4||||0.145|TWO_SIDED|95.0|-38.4|5.7|||Mixed Models Analysis|||Lipoprotein(a)||5.7|-38.4|0.145
71665403|NCT04873934|142844988|SUPERIORITY||LS mean difference|3.5||||0.141|TWO_SIDED|95.0|-1.2|8.1|||Mixed Models Analysis|||HDL Cholesterol||8.1|-1.2|0.141
71665404|NCT04873934|142844988|SUPERIORITY||LS mean difference|-5.0||||0.339|TWO_SIDED|95.0|-15.2|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-15.2|0.339
71665405|NCT04873934|142844989|SUPERIORITY||LS mean difference|-28.4|||<|0.001|TWO_SIDED|95.0|-33.0|-23.9|||Mixed Models Analysis|||Apolipoprotein B||-23.9|-33.0|< 0.001
71665406|NCT04873934|142844989|SUPERIORITY||LS mean difference|-2.1||||0.078|TWO_SIDED|95.0|-4.5|0.2|||Mixed Models Analysis|||VLDL Cholesterol||0.2|-4.5|0.078
71665407|NCT04873934|142844989|SUPERIORITY||LS mean difference|-40.1|||<|0.001|TWO_SIDED|95.0|-47.5|-32.8|||Mixed Models Analysis|||Non-HDL Cholesterol||-32.8|-47.5|< 0.001
71665408|NCT04873934|142844989|SUPERIORITY||LS mean difference|-37.7|||<|0.001|TWO_SIDED|95.0|-45.3|-30.2|||Mixed Models Analysis|||Total Cholesterol||-30.2|-45.3|< 0.001
71665409|NCT04873934|142844989|SUPERIORITY||LS mean difference|1.9||||0.065|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||HDL Cholesterol||3.8|-0.1|0.065
71665410|NCT04873934|142844989|SUPERIORITY||LS mean difference|-8.7||||0.222|TWO_SIDED|95.0|-22.8|5.3|||Mixed Models Analysis|||Triglycerides||5.3|-22.8|0.222
71665411|NCT04873934|142844990|SUPERIORITY||LS mean difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Lipoprotein(a)||-4.2|-23.8|0.005
71665412|NCT04873934|142844991|SUPERIORITY||Odds Ratio (OR)|0.43||||0.031|TWO_SIDED|95.0|0.2|0.93|||proportional odds model|||||0.93|0.20|0.031
71665413|NCT04873934|142844992|SUPERIORITY||LS mean difference|-0.039||||0.043|TWO_SIDED|95.0|-0.077|-0.001|||ANCOVA|||||-0.001|-0.077|0.043
71665414|NCT04873934|142844993|SUPERIORITY||Odds Ratio (OR)|0.76||||0.346|TWO_SIDED|95.0|0.43|1.35|||Regression, Logistic|||||1.35|0.43|0.346
71665415|NCT04784533|142845041|SUPERIORITY||Difference in percentages|16.2|||||TWO_SIDED|95.0|5.5|26.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||26.8|5.5|
71665416|NCT04784533|142845041|SUPERIORITY||Difference in percentages|12.1|||||TWO_SIDED|95.0|1.3|22.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.9|1.3|
71665417|NCT04784533|142845041|SUPERIORITY||Difference in percentages|26.4|||||TWO_SIDED|95.0|15.4|37.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||37.5|15.4|
71778465|NCT01967173|143056483|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250||||0.48
71778466|NCT01967173|143056483|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100||||0.14
71665418|NCT04784533|142845041|SUPERIORITY||Difference in percentages|19.9|||||TWO_SIDED|95.0|8.5|31.3|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.3|8.5|
71665419|NCT04784533|142845042|SUPERIORITY||Difference in percentages|0.6|||||TWO_SIDED|95.0|-2.7|3.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 8||3.9|-2.7|
71665420|NCT04784533|142845042|SUPERIORITY||Difference in percentages|10.6|||||TWO_SIDED|95.0|3.3|17.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||17.9|3.3|
71665421|NCT04784533|142845042|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|5.3|22.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||22.8|5.3|
71665422|NCT04784533|142845042|SUPERIORITY||Difference in percentages|19.4|||||TWO_SIDED|95.0|9.2|29.5|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||29.5|9.2|
71778467|NCT01967173|143056483|SUPERIORITY|||||||0.096|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100||||0.096
71778468|NCT02002832|143056504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.|Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.0|6.3|||Mixed Models Analysis|||||6.3|1.0|
71778469|NCT00492531|143056745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.7|TWO_SIDED|95.0|-56.0|38.0|||ANCOVA|6 minute walk was based on ANCOVA model with treatment as a fixed effect and 6 minute walk distance, TRV stratum and study site as covariate.||||38|-56|0.70
71665423|NCT04784533|142845042|SUPERIORITY||Difference in percentages|20.8|||||TWO_SIDED|95.0|9.8|31.7|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.7|9.8|
71665424|NCT04784533|142845043|SUPERIORITY||Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|-2.8|1.8|||||LS means,standard error(SE),and confidence intervals(CIs) are based on mixed model repeated measures(MMRM)analysis with effects for treatment,visit,treatment-by-visit interaction,and baseline value.The Model uses an unstructured covariance structure.|Week 4||1.8|-2.8|
71665425|NCT04784533|142845043|SUPERIORITY||LS Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-11.9|-2.7|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 8||-2.7|-11.9|
71665426|NCT04784533|142845043|SUPERIORITY||LS Mean Difference|-12.4|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-19.3|-5.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-5.5|-19.3|
71665427|NCT04784533|142845043|SUPERIORITY||LS Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-22.2|-6.9|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-6.9|-22.2|
71665428|NCT04784533|142845043|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-23.7|-7.2|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-7.2|-23.7|
71778470|NCT03685123|143056756|SUPERIORITY|||||||0.256|||||||Mixed Models Analysis|||||||0.256
71778471|NCT03685123|143056757|SUPERIORITY|||||||0.089|||||||Mixed Models Analysis|||||||0.089
71778472|NCT03685123|143056758|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||||||0.244
71778473|NCT03685123|143056759|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
71778474|NCT03685123|143056760|SUPERIORITY|||||||0.983|||||||Mixed Models Analysis|||LDL levels||||0.983
71778475|NCT03685123|143056760|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||HDL levels||||0.56
71665429|NCT04784533|142845043|SUPERIORITY||LS Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|4.36|||TWO_SIDED|95.0|-24.0|-6.8|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-6.8|-24.0|
71665430|NCT04784533|142845044|SUPERIORITY||Difference in percentages|20.9|||||TWO_SIDED|95.0|9.9|31.8|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||31.8|9.9|
71745208|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.71|||||TWO_SIDED|95.0|85.13|96.93|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 2.||96.93|85.13|
71745209|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.01|||||TWO_SIDED|95.0|82.82|96.88|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 2.||96.88|82.82|
71745210|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.36|||||TWO_SIDED|95.0|84.98|96.59|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 3.||96.59|84.98|
71778476|NCT03685123|143056760|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Total Cholesterol||||0.71
71778477|NCT03685123|143056760|SUPERIORITY|||||||0.313|||||||Mixed Models Analysis|||Triglycerides||||0.313
71778478|NCT03685123|143056761|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||systolic Blood pressure||||0.72
71778479|NCT03685123|143056761|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||Diastolic Blood pressure||||0.61
71778480|NCT03685123|143056761|SUPERIORITY|||||||0.1609|||||||Mixed Models Analysis|||Change in aortic blood pressure between the PA-REC and the WM-REC Groups.||||0.1609
71890988|NCT02207907|143304027|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.491|||<|0.0001|TWO_SIDED|95.0|-20.317|-14.664|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-14.664|-20.317|<0.0001
71665431|NCT04784533|142845044|SUPERIORITY||Difference in percentages|13.8|||||TWO_SIDED|95.0|2.5|25.2|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||25.2|2.5|
71778481|NCT03685123|143056761|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||Change in aortic diastolic blood pressure between the PA-REC and WM-REC Groups||||0.446
71778482|NCT03685123|143056762|SUPERIORITY|||||||0.965|||||||Mixed Models Analysis|||||||0.965
71778483|NCT03685123|143056763|SUPERIORITY|||||||0.857|||||||Mixed Models Analysis|||||||0.857
71665432|NCT04784533|142845044|SUPERIORITY||Difference in percentages|15.6|||||TWO_SIDED|95.0|4.1|27.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||27.0|4.1|
71665433|NCT04784533|142845044|SUPERIORITY||Difference in percentages|14.4|||||TWO_SIDED|95.0|2.9|25.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||25.9|2.9|
71778484|NCT03685123|143056764|SUPERIORITY|||||||0.825|||||||Mixed Models Analysis|||||||0.825
71665434|NCT04784533|142845045|SUPERIORITY||Difference in percentages|22.9|||||TWO_SIDED|95.0|11.9|34.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 12||34.0|11.9|
71745211|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.2|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 3.||100.00|89.20|
71778485|NCT03685123|143056765|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.061
71778486|NCT03685123|143056767|SUPERIORITY|Change in particle size between the PA-REC and WM-REC groups||||||0.105|||||||Mixed Models Analysis|||Change in HDL particle size||||0.105
71778487|NCT03685123|143056767|SUPERIORITY|Change in particle size between the PA-REC and the WM-REC groups||||||0.849|||||||Mixed Models Analysis|||Change in LDL particles||||0.849
71778488|NCT03685123|143056769|SUPERIORITY|||||||0.278|||||||ANOVA|||Change in steps per day from week 10 to week 28||||0.278
71778489|NCT03685123|143056770|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Change in SF-36 General Health (GH)||||0.238
71890989|NCT02207907|143304028|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.201|||<|0.0001|TWO_SIDED|95.0|-0.237|-0.165|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.165|-0.237|<0.0001
71890990|NCT02620020|143304033|SUPERIORITY||Least Squares (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3876|TWO_SIDED|95.0|-0.88|0.34||Nominal p-value|Mixed Models Analysis|||||0.34|-0.88|0.3876
71890991|NCT02620020|143304033|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.018|TWO_SIDED|95.0|-1.32|-0.12||Nominal p-value|Mixed Models Analysis|||||-0.12|-1.32|0.0180
71665435|NCT04784533|142845045|SUPERIORITY||Difference in percentages|21.9|||||TWO_SIDED|95.0|10.7|33.1|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 16||33.1|10.7|
71665436|NCT04784533|142845045|SUPERIORITY||Difference in percentages|22.6|||||TWO_SIDED|95.0|11.2|33.9|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 20||33.9|11.2|
71665437|NCT04784533|142845045|SUPERIORITY||Difference in percentages|19.5|||||TWO_SIDED|95.0|8.1|31.0|||||Treatment difference is calculated as the difference between the percentage of responders in the 12 mg BID group versus the 8 mg BID group.|Week 24||31.0|8.1|
71665438|NCT04784533|142845046|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.9|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 12||-0.3|-0.9|
71745212|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|89.39|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 3.||100.00|89.39|
71745213|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.84|||||TWO_SIDED|95.0|79.81|95.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 3.||95.51|79.81|
71745214|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.74|||||TWO_SIDED|95.0|68.99|93.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 3.||93.35|68.99|
71745215|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.75|||||TWO_SIDED|95.0|80.31|95.24|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 4.||95.24|80.31|
71745216|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.88|||||TWO_SIDED|95.0|60.62|99.85|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 4.||99.85|60.62|
71745217|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.62|||||TWO_SIDED|95.0|66.1|99.04|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 4.||99.04|66.10|
71778490|NCT03685123|143056770|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.124|||||||Mixed Models Analysis|||Change in SF-36 Physical health (PH)||||0.124
71665439|NCT04784533|142845046|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.1|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 16||-0.4|-1.1|
71665440|NCT04784533|142845046|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 20||-0.4|-1.2|
71665441|NCT04784533|142845046|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.2|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value. The model is fit using an unstructured covariance structure.|Week 24||-0.3|-1.2|
71665442|NCT04784533|142845047|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 12||-0.1|-0.7|
71745218|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.96|||||TWO_SIDED|95.0|77.96|95.13|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 4.||95.13|77.96|
71778491|NCT03685123|143056770|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.769|||||||Mixed Models Analysis|||Change in SF-36 role physical||||0.769
71778492|NCT03685123|143056770|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.352|||||||Mixed Models Analysis|||Change in SF-36 Bodily Pain||||0.352
71778493|NCT03685123|143056770|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.898|||||||Mixed Models Analysis|||Change in SF-36 Vitality||||0.898
71778494|NCT03685123|143056770|SUPERIORITY|Between groups analysis between the change in PA-REC Group vs. the WM-REC Group||||||0.444|||||||Mixed Models Analysis|||Change in SF-36 social function||||0.444
71778495|NCT03685123|143056770|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health||||0.537
71778496|NCT03685123|143056770|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||Change in SF-36 Role Emotional||||0.448
71778497|NCT03685123|143056770|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.537|||||||Mixed Models Analysis|||Change in SF-36 Mental Health (Sum)||||0.537
71778498|NCT03685123|143056770|SUPERIORITY|Change between the PA-REC group and the WM-REC group||||||0.482|||||||Mixed Models Analysis|||Change in SF-36 Physical Health (sum)||||0.482
71778499|NCT03685123|143056772|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71778500|NCT03685123|143056773|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
71778501|NCT03685123|143056774|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in body fat||||<0.001
71778502|NCT03685123|143056775|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71778503|NCT03685123|143056776|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||LDL||||0.004
71778504|NCT03685123|143056776|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Change in HDL||||0.04
71778505|NCT03685123|143056776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in Total Cholesterol||||<0.001
71778506|NCT03685123|143056776|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Triglycerides||||<0.001
71890992|NCT02620020|143304033|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0288|TWO_SIDED|95.0|-1.26|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-1.26|0.0288
71778507|NCT03685123|143056777|SUPERIORITY|||||||0.01||||||Systolic blood pressure|Mixed Models Analysis|||||||0.01
71778508|NCT03685123|143056777|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Diastolic blood pressure||||0.001
71778509|NCT03685123|143056777|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Aortic blood pressure (mmHg)||||<0.001
71778510|NCT03685123|143056777|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in aortic diastolic pressure||||<0.001
71778511|NCT03685123|143056778|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71778512|NCT03685123|143056779|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71778513|NCT03685123|143056780|SUPERIORITY|||||||0.366|||||||Mixed Models Analysis|||||||0.366
71778514|NCT03685123|143056781|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71778515|NCT03685123|143056783|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71778516|NCT03685123|143056784|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71778517|NCT03685123|143056785|SUPERIORITY||||||<|0.001||||||General Health|Mixed Models Analysis|||||||<0.001
71778518|NCT03685123|143056785|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health||||<0.001
71778519|NCT03685123|143056785|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||Role physical||||0.023
71778520|NCT03685123|143056785|SUPERIORITY||||||<|0.001||||||Bodily Pain|Mixed Models Analysis|||||||<0.001
71778521|NCT03685123|143056785|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Vitality||||<0.001
71778522|NCT03685123|143056785|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Social Functioning||||<0.001
71778523|NCT03685123|143056785|SUPERIORITY|||||||0.0105|||||||Mixed Models Analysis|||Mental Health||||0.0105
71778524|NCT03685123|143056785|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Role Emotional||||<0.001
71778525|NCT03685123|143056785|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||SF-36 mental health Components (sum)||||0.01
71778526|NCT03685123|143056785|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Physical Health Components Sum||||<0.001
71778527|NCT03685123|143056786|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Change in kilocalories consumed from baseline to week 10||||<0.001
71778528|NCT03685123|143056787|SUPERIORITY|||||||0.658|||||||Mixed Models Analysis|||Change in LDL Particle Size||||0.658
71778529|NCT03685123|143056787|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||HDL participle size||||0.07
71778530|NCT02628938|143056800|SUPERIORITY_OR_OTHER|||||||0.299|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth wash||||0.299
71778531|NCT02628938|143056800|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth wash||||0.007
71778532|NCT02628938|143056800|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticks||||0.019
71778533|NCT02628938|143056800|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticks||||0.000
71778534|NCT02628938|143056800|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.000
71890993|NCT02620020|143304035|SUPERIORITY||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.73||0.0028|TWO_SIDED|95.0|-3.65|-0.77||Nominal p-value|Mixed Models Analysis|||||-0.77|-3.65|0.0028
71890994|NCT02620020|143304035|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.72||0.0068|TWO_SIDED|95.0|-3.36|-0.54||Nominal p-value|Mixed Models Analysis|||||-0.54|-3.36|0.0068
71890995|NCT02620020|143304035|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.72||0.0006|TWO_SIDED|95.0|-3.88|-1.06||Nominal p-value|Mixed Models Analysis|||||-1.06|-3.88|0.0006
71890996|NCT02620020|143304036|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1501|TWO_SIDED|95.0|-0.46|0.07||Nominal p-value|Mixed Models Analysis|||||0.07|-0.46|0.1501
71665443|NCT04784533|142845047|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.0|-0.3|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 16||-0.3|-1.0|
71745219|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.86|||||TWO_SIDED|95.0|73.3|95.33|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 4.||95.33|73.30|
71745220|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.87|||||TWO_SIDED|95.0|68.31|92.63|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 6.||92.63|68.31|
71745221|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|46.83|98.61|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 6.||98.61|46.83|
71745222|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.31|||||TWO_SIDED|95.0|48.79|99.82|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 6.||99.82|48.79|
71745223|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.98|||||TWO_SIDED|95.0|63.64|93.05|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 6.||93.05|63.64|
71745224|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.0|||||TWO_SIDED|95.0|54.3|92.5|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 6.||92.50|54.30|
71745225|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|83.61|||||TWO_SIDED|95.0|67.76|92.51|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 7.||92.51|67.76|
71745226|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|93.33|||||TWO_SIDED|95.0|56.67|99.84|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 7.||99.84|56.67|
71778535|NCT02628938|143056800|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.001
71745227|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 7.||98.31|32.04|
71745228|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.43|||||TWO_SIDED|95.0|59.54|91.58|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 7.||91.58|59.54|
71778536|NCT02628938|143056801|SUPERIORITY_OR_OTHER|||||||0.496|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth wash||||0.496
71665444|NCT04784533|142845047|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-1.2|-0.5|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 20||-0.5|-1.2|
71665445|NCT04784533|142845047|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.2|-0.4|||||LS means, SE, and CIs are based on an MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Week 24||-0.4|-1.2|
71665446|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 12||-0.2|-0.7|
71665447|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 16||-0.2|-0.7|
71665448|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 20||-0.3|-0.8|
71665449|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Thickness Hair Coverage: Week 24||-0.2|-0.8|
71778537|NCT02628938|143056801|SUPERIORITY_OR_OTHER|||||||0.244|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth wash||||0.244
71778538|NCT02628938|143056801|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticks||||0.19
71778539|NCT02628938|143056801|SUPERIORITY_OR_OTHER|||||||0.829|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticks||||0.829
71778540|NCT02628938|143056801|SUPERIORITY_OR_OTHER|||||||0.341|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash||||0.341
71665450|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 12||-0.3|-0.8|
71665451|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.7|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 16||-0.3|-0.7|
71665452|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 20||-0.3|-0.8|
71665453|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|Satisfied Evenness Hair Coverage: Week 24||-0.3|-0.8|
71665454|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 12||-0.2|-0.8|
71665455|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 16||-0.1|-0.6|
71665456|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.1|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 20||-0.1|-0.7|
71778541|NCT02628938|143056801|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.82
71778542|NCT02628938|143056802|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth wash||||0.008
71778543|NCT02628938|143056802|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticks||||0.001
71778544|NCT02628938|143056802|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth wash||||0.02
71778545|NCT03113916|143056803|SUPERIORITY||Slope|2.63|||=|0.001|TWO_SIDED|95.0|1.05|4.2|||Mixed Models Analysis|||||4.20|1.05|=.001
71778546|NCT03113916|143056804|SUPERIORITY||Slope|-0.49||||0.23|TWO_SIDED|95.0|-1.29|0.31|||Mixed Models Analysis|||||0.31|-1.29|.23
71778547|NCT03113916|143056805|SUPERIORITY||Slope|0.000000676||||0.06|TWO_SIDED|95.0|-0.00000002|0.00000137|||Mixed Models Analysis|||||.00000137|-.00000002|.06
71778548|NCT03113916|143056806|SUPERIORITY||Slope|-5.64||||0.29|TWO_SIDED|95.0|-16.0|4.73|||Mixed Models Analysis||Values given need to be multiplied by 10 to the power of -10 (i.e., x 10\^-10).|||4.73|-16|.29
71778549|NCT03113916|143056807|SUPERIORITY||Slope|0.351||||0.27|TWO_SIDED|95.0|-0.277|0.978|||Mixed Models Analysis|||||.978|-.277|.27
71778550|NCT03113916|143056808|SUPERIORITY||Slope|-0.015||||0.1|TWO_SIDED|95.0|-0.032|0.003|||Mixed Models Analysis|||||.003|-.032|.10
71778551|NCT03113916|143056809|SUPERIORITY||Slope|-11.2||||0.07|TWO_SIDED|95.0|-23.0|0.7|||Mixed Models Analysis|||||0.7|-23.0|.07
71778552|NCT03113916|143056810|SUPERIORITY||Slope|-0.63||||0.12|TWO_SIDED|95.0|-1.41|0.16|||Mixed Models Analysis|||||0.16|-1.41|.12
71778553|NCT03113916|143056811|SUPERIORITY||Slope|0.174||||0.008|TWO_SIDED|95.0|0.05|0.302|||Mixed Models Analysis|||||.302|.050|.008
71778554|NCT03113916|143056812|SUPERIORITY||Slope|0.015||||0.5|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|||||.059|-.029|.50
71778555|NCT03113916|143056813|SUPERIORITY||Slope|-0.00003||||0.99|TWO_SIDED|95.0|-0.013|0.013|||Mixed Models Analysis|||||.013|-.013|.99
71778556|NCT00621959|143056825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.546||95.0|-0.59|0.31||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA including treatment and center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.31|-0.59|0.546
71778557|NCT00621959|143056826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08||||0.442||95.0|-0.27|0.12||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.12|-0.27|0.442
71778558|NCT01758523|143056827|OTHER|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71778559|NCT01758523|143056828|OTHER|||||||0.028|||||||Mixed Models Analysis|||||||0.028
71665457|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyebrows: Week 24||-0.2|-0.7|
71778560|NCT01758523|143056829|OTHER||Odds Ratio (OR)|2.49||||0.057|TWO_SIDED|95.0|0.96|6.45|||Chi-squared|||||6.45|0.96|0.057
71778561|NCT01758523|143056830|OTHER||Odds Ratio (OR)|5.5||||0.007|TWO_SIDED|95.0|1.5|20.7|||Fisher Exact|||||20.7|1.5|0.007
71778562|NCT01758523|143056831|OTHER|||||||0.87||||||significance for drug x AKR1C3\*2 G-carrier genotype|Mixed Models Analysis|||||||0.87
71778563|NCT01758523|143056832|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.030
71778564|NCT03439657|143056841|NON_INFERIORITY|Upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies Geometric Mean Concentration (GMC) ratio between the Control group and the Co-Ad group should be \<1.5.|GMC ratio|1.07|||||TWO_SIDED|95.0|0.99|1.16|||ANCOVA|The 95% CI of the group GMCs ratio was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-gE GMCs (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean concentrations (GMCs) for anti-gE antibodies, one month after the administration of last vaccine dose.||1.16|0.99|
71778565|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-1), one month after the administration of Prevnar 13 vaccine dose.||1.33|0.82|
71778566|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.86|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-3), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.86|
71778567|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.02|1.52|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-4), one month after the administration of Prevnar 13 vaccine dose.||1.52|1.02|
71778568|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.04|||||TWO_SIDED|95.0|0.81|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-5), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.81|
71778569|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.26|||||TWO_SIDED|95.0|1.02|1.56|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6A), one month after the administration of Prevnar 13 vaccine dose.||1.56|1.02|
71778570|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.07|1.73|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-6B), one month after the administration of Prevnar 13 vaccine dose.||1.73|1.07|
71778571|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.21|||||TWO_SIDED|95.0|1.01|1.44|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-7F), one month after the administration of Prevnar 13 vaccine dose.||1.44|1.01|
71778572|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.16|||||TWO_SIDED|95.0|0.97|1.39|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-9V), one month after the administration of Prevnar 13 vaccine dose.||1.39|0.97|
71778573|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.15|||||TWO_SIDED|95.0|0.94|1.42|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-14), one month after the administration of Prevnar 13 vaccine dose.||1.42|0.94|
71778574|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.92|1.34|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-18C), one month after the administration of Prevnar 13 vaccine dose.||1.34|0.92|
71778575|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.87|1.22|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19A), one month after the administration of Prevnar 13 vaccine dose.||1.22|0.87|
71778576|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.09|||||TWO_SIDED|95.0|0.9|1.32|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-19F), one month after the administration of Prevnar 13 vaccine dose.||1.32|0.90|
71665458|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 12||-0.2|-0.7|
71665459|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 16||-0.2|-0.7|
71778577|NCT03439657|143056842|NON_INFERIORITY|Upper limit (UL) of 95% CI for each individual pneumococcal conjugate serotype Geometric Mean Titer (GMT) ratio of the Control group over the Co-Ad group should be \<2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.96|1.5|||ANCOVA|The 95% CI of the group MOPA GMT ratios was computed using an Analysis Of Covariance (ANCOVA) model on the log10 transformation of the concentrations.||Anti-pneumococcal antibody titers (non-inferiority): Non-inferiority comparison between Control Group and Co-Ad Group in terms of geometric mean titers (GMTs) for anti-pneumococcal antibody (MOPA-23F), one month after the administration of Prevnar 13 vaccine dose.||1.50|0.96|
71665460|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.7|-0.2|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 20||-0.2|-0.7|
71665461|NCT04784533|142845048|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.8|-0.3|||||LS means, SEs, and CIs are based on a mixed model repeated measures analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score. The model is fit using an unstructured covariance structure.|How Satisfied With Your Eyelashes: Week 24||-0.3|-0.8|
71665462|NCT00307437|142845052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||<0.001
71665463|NCT00307437|142845052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 1200 participants (400 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
71665464|NCT00307437|142845053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||||||<0.001
71665465|NCT00307437|142845053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint need to be significant first.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[less than or equal 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significancd level of 0.05.||||<0.001
71665466|NCT00307437|142845054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
71665467|NCT00307437|142845054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first.|ANOVA on van der Waerden normal scores|Analysis of varianceon van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤90 kg vs \>90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
71665468|NCT00307437|142845055|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.468
71665469|NCT00307437|142845055|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||||||0.210
71665470|NCT00307437|142845055|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested.|Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight \[less than or equal to 90 kg vs greater than 90 kg)\].||Null Hypothesis: No difference between combined q8 group and the combined q12 group, 45 mg q8 and 45 mg q12, 90 mg q8 and 90 mg q12 at an overall significance level of 0.05.||||0.014
71665471|NCT00708227|142845063|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
71665472|NCT00708227|142845064|SUPERIORITY|||||||0.15|||||||ANOVA|||||||0.15
71665473|NCT00708227|142845065|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
71665474|NCT03765788|142845078|SUPERIORITY||Odds Ratio (OR)|9.31|||||TWO_SIDED|95.0|3.54|26.29|||||Odd Ratio (posterior median) median and 95% credibility interval calculated using the Bayesian inference|Odds Ratio||26.29|3.54|
71665475|NCT02640482|142845093|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate noninferiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of using a single binomial proportion a one-sample test for superiority).||100.0|98.5|
71665476|NCT02640482|142845094|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 95% to achieve superiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides \>90% power to demonstrate superiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of a single binomial proportion using a one-sample test for superiority).||100.0|98.5|
71890997|NCT02620020|143304036|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.2603|TWO_SIDED|95.0|-0.41|0.11||Nominal p-value|Mixed Models Analysis|||||0.11|-0.41|0.2603
71890998|NCT02620020|143304036|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0135|TWO_SIDED|95.0|-0.59|-0.07||Nominal p-value|Mixed Models Analysis|||||-0.07|-0.59|0.0135
71890999|NCT03068715|143304055|SUPERIORITY|We assessed the superiority of active over sham.|||||<|0.001|||||||Mixed Models Analysis|||MADRS scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||<0.001
71745229|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|78.79|||||TWO_SIDED|95.0|51.24|92.08|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 7.||92.08|51.24|
71834610|NCT00818246|143173634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.||||<0.0001
71834611|NCT01619410|143173671|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71834612|NCT04110054|143173681|EQUIVALENCE|Placebo (N = 102) vs S-600918 50 mg, 150 mg, 300 mg||||||0.9334||||||P-value was evaluated at the 2-sided alpha level of 0.05.|ANCOVA|||The null hypotheses of equality between the treatment and placebo effects were tested using a mixed model, containing treatment group, week, and interaction between treatment groups and week as fixed effects; participant as random effect; and region and the common logarithm of the frequency of coughs per hour at baseline as covariates. Covariance structure was given as unstructured.||||0.9334
71834613|NCT00093015|143173692|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.41||95.0|0.94|1.17||Nominal p-value from a 2-sided log rank test is presented. The primary cardiovascular composite endpoint was tested at the 0.04056 significance level at final analysis after accounting for 4 planned interim analyses (overall alpha = 0.048).|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.17|0.94|0.41
71834614|NCT00093015|143173693|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.29||95.0|0.95|1.19||Nominal p-value from a 2-sided log rank test is presented. The primary renal composite endpoint was tested at the 0.002 significance level at final analysis.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.19|0.95|0.29
71665477|NCT02794870|142845123|OTHER||% vaccine recipients with solicited AEs|60.0|||||TWO_SIDED|90.0|39.0|78.0||||||||78|39|
71745230|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.76|||||TWO_SIDED|95.0|65.98|92.14|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 8.||92.14|65.98|
71745231|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 8.||98.52|42.67|
71745232|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.62|||||TWO_SIDED|95.0|32.04|98.31|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 8.||98.31|32.04|
71745233|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|81.4|||||TWO_SIDED|95.0|59.97|92.45|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 8.||92.45|59.97|
71745234|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|80.65|||||TWO_SIDED|95.0|52.91|93.4|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 8.||93.40|52.91|
71665478|NCT02794870|142845123|OTHER||% placebo recipients with solicited AEs|27.0|||||TWO_SIDED|90.0|8.0|56.0||||||||56|8|
71778578|NCT00370071|143056858|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||In this single arm study, the number of newly active lesions per 3 months during treatment was compared to the number of newly active lesions during 3-month pre-treatment (Alternative hypothesis: Number of lesions is reduced during treatment with Interferon beta-1b). The sample size was calculated for the use of the one-sided Wilcoxon-Signed-Rank test at level 2.5% (Power of 90% - anticipating P(X\&lt;Y)=0.15 and allowing for 25% exclusion from Per Protocol Set).||||<0.0001
71778579|NCT00370071|143056859|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||<0.0001
71778580|NCT00370071|143056860|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||||||0.0017
71778581|NCT00370071|143056861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon-Signed-Rank test|One-sided p-value from Wilcoxon-Signed-Rank-Test for comparing the baseline visit to treatment visits||Lesion volume at Week 12. 38 subjects were evaluated.||||<0.0001
71778582|NCT00370071|143056861|SUPERIORITY_OR_OTHER||||||=|0.0019|||||||Wilcoxon-Signed-Rank test|||Lesion volume at Week 24. 37 subjects were evaluated.||||=0.0019
71834615|NCT00093015|143173694|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.48||95.0|0.92|1.21||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.21|0.92|0.48
71834616|NCT00093015|143173695|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.61||95.0|0.88|1.25||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.25|0.88|0.61
71834617|NCT00093015|143173696|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.96||||0.73||95.0|0.75|1.23||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.23|0.75|0.73
71834618|NCT00093015|143173697|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.92|||<|0.001||95.0|1.38|2.68||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||2.68|1.38|<0.001
71778583|NCT00502944|143056870|SUPERIORITY_OR_OTHER||Rate Difference (%)|30.0|||<|0.001|TWO_SIDED|95.0|27.0|32.0|||Chi-squared|||HIV test completed among patients randomized||32|27|<0.001
71778584|NCT00502944|143056871|SUPERIORITY_OR_OTHER||Rate Difference (%)|44.0|||<|0.001|TWO_SIDED|95.0|42.0|47.0|||Chi-squared|||HIV test offered||47|42|<0.001
71834619|NCT00093015|143173698|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.24||95.0|0.74|1.08||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.08|0.74|0.24
71834620|NCT00093015|143173699|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.02||||0.83||95.0|0.87|1.18||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.18|0.87|0.83
71665479|NCT02794870|142845124|OTHER||% vaccinees with unsolicited AEs|35.0|||||TWO_SIDED|90.0|18.0|56.0||||||||56|18|
71665480|NCT02794870|142845124|OTHER||% placebo with unsolicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0||||||||47|3|
71778585|NCT00502944|143056872|SUPERIORITY_OR_OTHER||Rate Difference (%)|-4.0||||0.02|TWO_SIDED|95.0|-8.0|-1.0|||Chi-squared|||HIV test accepted among patients offered||-1|-8|0.02
71813056|NCT01564368|143128443|SUPERIORITY||area under the curve|0.68|||<|0.001|ONE_SIDED|95.0||0.75||Bonferroni's correction was used for multiple comparisons adjustment, where p\<0.003 (0.05/15) was considered statistically significant.|Z-test|The empirical AUC was tested by using variance derived from the method of DeLong|Receiver operating characteristic curve and AUC were estimated empirically, and its 95% CI was constructed using variance derived from DeLong's method|Receiver Operating Characteristic curves and the corresponding Area Under the Curve (AUC), were estimated for the change in functional tumor volumes (FTV3 - FTV0)/FTV0 (Test: %change in FTV; Reference: pCR) detect a difference of 0.15 between the AUC under H0: AUC=0.5 and an AUC under the alternative hypothesis of 0.65. It was assumed that the number of pCR non-responders would be approximately 2.7 times greater than the number of complete responders||0.75||<0.001
71813057|NCT01564368|143128444|EQUIVALENCE|no equivalence margin was used.||||||0.032|||||||z-test|||AUC (optimized) = AUC (ΔADC)||||0.032
71745235|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|73.68|||||TWO_SIDED|95.0|52.89|86.16|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 9.||86.16|52.89|
71745236|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|66.67|||||TWO_SIDED|95.0|3.52|90.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 9.||90.52|3.52|
71745237|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.73|||||TWO_SIDED|95.0|-3.24|95.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 9.||95.11|-3.24|
71745238|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|76.19|||||TWO_SIDED|95.0|51.78|89.35|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 9.||89.35|51.78|
71778586|NCT02569671|143056918|NON_INFERIORITY|"is less than the non-inferiority margin (indicating non-inferior bone gain).~The hypotheses associated with the primary analysis are defined as:~H0: µc - µs ≥ δ H1: µc - µs \< δ where µc is the mean change in crestal bone levels from implant loading to 12 months post-implant loading for the treatment group, µs is the mean change for the control group, and δ is the 0.5 mm non-inferiority margin. The hypotheses will be tested using a one-sided t-test with a 5% significance level."|Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.5||0.95|ONE_SIDED|95.0||||SD for both test and control group is 0.5 mm, A difference between groups of ≥ 0.5 mm is considered clinically significant, The difference between the treatment groups is expected to be 0 mm, Statistical test will be one-sided 5% significance level.|t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The hypotheses will be tested using a one-sided t-test with a 5% significance level.|The null hypothesis for the primary analysis is that the difference between the mean change in crestal bone levels for the treatment and control groups is at least the non-inferiority margin (indicating inferior bone gain). Rejection of the null hypothesis indicates the observed data supports the alternative hypothesis that the difference between the mean change in crestal bone levels for the treatment and control groups|The change in mean bone level from implant loading to 12-month follow-up was calculated. Change in crestal bone levels was calculated as the crestal bone level at 12-months post implant loading minus crestal bone level at implant loading.|||.950
71778587|NCT02569671|143056920|NON_INFERIORITY|Smaller bone dimensional thickness of the buccal plate measurements indicates less bone loss and better healing.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.3||0.022|ONE_SIDED|95.0|||||t-test, 1 sided|The hypotheses will be tested using a one-sided t-test with a 5% significance level.||All secondary effectiveness endpoints were planned to be summarized descriptively, and no hypothesis tests was planned.||||0.022
71778588|NCT05764408|143056927|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.49|1.35||||||||1.35|0.49|
71778589|NCT05764408|143056928|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.39|1.86||||||||1.86|0.39|
71778590|NCT05764408|143056929|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
71778591|NCT05764408|143056931|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
71745239|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|75.86|||||TWO_SIDED|95.0|43.69|91.07|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 9.||91.07|43.69|
71778592|NCT05764408|143056932|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.07|16.12||||||||16.12|0.07|
71778593|NCT02110238|143056935|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A VAS (0-100 mm) WOMAC Pain subscale score CFB; an equal n t-test for non-inferiority of means; a non-inferiority margin of -8 mm; change standard deviation of 26 mm; two-sided alpha=0.05; 80% power; an expected mean difference of 0, and a drop-out plus important deviation percentage of approximately 20% were used to establish study sample size.|Least square mean difference|-3.3|||||TWO_SIDED|95.0|-6.77|0.17|||||"A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 single point estimate least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated."|||0.17|-6.77|
71778594|NCT01419626|143056946|SUPERIORITY||Difference in LS mean|-0.461|||<|0.001|TWO_SIDED|95.0|-0.581|-0.341|||ANCOVA|||Statistical analysis at Week 4||-0.341|-0.581|<0.001
71778595|NCT01419626|143056946|SUPERIORITY||Difference in LS mean|-0.669|||<|0.001|TWO_SIDED|95.0|-0.789|-0.549|||ANCOVA|||Statistical analysis at Week 4||-0.549|-0.789|<0.001
71778596|NCT01419626|143056946|SUPERIORITY|Statistical analysis at Week 4|Difference in LS mean|-0.208|||<|0.001|TWO_SIDED|95.0|-0.326|-0.09|||ANCOVA|||||-0.090|-0.326|<0.001
71778597|NCT01419626|143056947|SUPERIORITY||Difference in LS mean|-0.494|||<|0.001|TWO_SIDED|95.0|-0.625|-0.363|||ANCOVA|||Statistical analysis at Week 4||-0.363|-0.625|<0.001
71778598|NCT01419626|143056947|SUPERIORITY||Difference in LS mean|-0.697|||<|0.001|TWO_SIDED|95.0|-0.828|-0.567|||ANCOVA|||Statistical analysis at Week 4||-0.567|-0.828|<0.001
71778599|NCT01419626|143056947|SUPERIORITY||Difference in LS mean|-0.203||||0.002||95.0|-0.333|-0.074|||ANCOVA|||Statistical analysis at Week 4||-0.074|-0.333|0.002
71665481|NCT02794870|142845129|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
71778600|NCT01419626|143056948|SUPERIORITY||Difference in LS mean|-0.04|||<|0.001|TWO_SIDED|95.0|-0.059|-0.021|||ANCOVA|||Statistical analysis at Week 2||-0.021|-0.059|<0.001
71778601|NCT01419626|143056948|SUPERIORITY||Difference in LS mean|-0.044|||<|0.001||95.0|-0.064|-0.025|||ANCOVA|||Statistical analysis at Week 2||-0.025|-0.064|<0.001
71665482|NCT02794870|142845130|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
71665483|NCT00230178|142845175|SUPERIORITY_OR_OTHER||Difference in response rate %|21.0||||0.0009||95.0|8.6|32.7|||Wilson's method|||||32.7|8.6|0.0009
71665484|NCT00230178|142845175|SUPERIORITY_OR_OTHER||Difference in response rate %|12.3||||0.0632||95.0|-0.9|25.0|||Wilson's method|||||25.0|-0.9|0.0632
71665485|NCT00230178|142845176|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71745240|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|71.7|||||TWO_SIDED|95.0|49.03|85.18|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 10.||85.18|49.03|
71745241|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.89|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 10.||100.00|77.89|
71745242|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.0|||||TWO_SIDED|95.0|29.71|99.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 10.||99.77|29.71|
71745243|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|60.53|||||TWO_SIDED|95.0|26.55|79.83|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 10.||79.83|26.55|
71665486|NCT00230178|142845176|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71665487|NCT03577301|142845178|SUPERIORITY||Wald Chi Square|3.3||||0.35|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 3 months.||||||0.35
71665488|NCT03577301|142845178|SUPERIORITY||Wald Chi Square|1.97||||0.58|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 6 months.||||||0.58
71745244|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|48.15|||||TWO_SIDED|95.0|-2.41|74.87|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 10.||74.87|-2.41|
71745245|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|82.0|||||TWO_SIDED|95.0|63.03|92.22|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group over Year 11.||92.22|63.03|
71778602|NCT01419626|143056948|SUPERIORITY||Difference in LS mean|-0.004||||0.671|TWO_SIDED|95.0|-0.023|0.015|||ANCOVA|||Statistical analysis at Week 2||0.015|-0.023|0.671
71778603|NCT01419626|143056948|SUPERIORITY||Difference in LS mean|-0.091|||<|0.001|TWO_SIDED|95.0|-0.121|-0.061|||ANCOVA|||Statistical analysis at Week 4||-0.061|-0.121|<0.001
71778604|NCT01419626|143056948|SUPERIORITY||Difference in LS mean|-0.144|||<|0.001|TWO_SIDED|95.0|-0.175|-0.114|||ANCOVA|||Statistical analysis at Week 4||-0.114|-0.175|<0.001
71778605|NCT01419626|143056948|SUPERIORITY||Difference in LS mean|-0.053|||<|0.001|TWO_SIDED|95.0|-0.083|-0.023|||ANCOVA|||Statistical analysis at Week 4||-0.023|-0.083|<0.001
71778606|NCT01419626|143056949|SUPERIORITY||Difference in LS mean|-0.09|||<|0.001|TWO_SIDED|95.0|-0.115|-0.065|||ANCOVA|||Statistical analysis at Week 2||-0.065|-0.115|<0.001
71778607|NCT01419626|143056949|SUPERIORITY||Difference in LS mean|-0.164|||<|0.001|TWO_SIDED|95.0|-0.189|-0.138|||ANCOVA|||Statistical analysis at Week 2||-0.138|-0.189|<0.001
71778608|NCT01419626|143056949|SUPERIORITY||Difference in LS mean|-0.073|||<|0.001|TWO_SIDED|95.0|-0.099|-0.048|||ANCOVA|||Statistical analysis at Week 2||-0.048|-0.099|<0.001
71778609|NCT01419626|143056949|SUPERIORITY||Difference in LS mean|-0.15|||<|0.001|TWO_SIDED|95.0|-0.18|-0.12|||ANCOVA|||Statistical analysis at Week 4||-0.120|-0.180|<0.001
71665489|NCT03577301|142845178|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 9 months.||||||0.64
71665490|NCT03577301|142845178|SUPERIORITY||Wald Chi Square|1.15||||0.76|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted illicit drug use at 12 months.||||||0.76
71745246|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.67|||||TWO_SIDED|95.0|42.67|98.52|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group over Year 11.||98.52|42.67|
71745247|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|65.07|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group over Year 11.||100.00|65.07|
71745248|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|79.41|||||TWO_SIDED|95.0|52.82|92.3|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group over Year 11.||92.30|52.82|
71745249|NCT02723773|143001587|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|72.0|||||TWO_SIDED|95.0|33.41|89.77|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group over Year 11.||89.77|33.41|
71745250|NCT02723773|143001588|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.5|||||TWO_SIDED|95.0|64.75|96.79|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control \>=50 YOA Group and Historical Control\>=50 YOA Group.||96.79|64.75|
71745251|NCT02723773|143001588|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|46.59|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 50-59 YOA Group over Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 50-59 YOA Group and Historical Control 50-59 YOA Group.||100.00|46.59|
71665491|NCT03577301|142845179|SUPERIORITY||Wald Chi Square|3.08||||0.38|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 3 months.||||||0.38
71665492|NCT03577301|142845179|SUPERIORITY||Wald Chi Square|1.26||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 6 months.||||||0.74
71745252|NCT02723773|143001588|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|50.0|||||TWO_SIDED|95.0|-860.45|99.15|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control 60-69 YOA Group over Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||99.15|-860.45|
71665493|NCT03577301|142845179|SUPERIORITY||Wald Chi Square|1.27||||0.74|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 9 months.||||||0.74
71665494|NCT03577301|142845179|SUPERIORITY||Slope|3.66||||0.3|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted condomless anal sex acts at 12 months.||||||0.300
71665495|NCT03577301|142845180|SUPERIORITY||Wald Chi Square|1.3||||0.73|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 3 months.||||||0.73
71665496|NCT03577301|142845180|SUPERIORITY||Wald Chi Square|1.68||||0.64|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 6 months.||||||0.64
71745253|NCT02723773|143001588|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|84.0|||||TWO_SIDED|95.0|53.66|95.95|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=60 YOA Group over Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||95.95|53.66|
71778610|NCT01419626|143056949|SUPERIORITY||Difference in LS mean|-0.257|||<|0.001|TWO_SIDED|95.0|-0.287|-0.226|||ANCOVA|||Statistical analysis at Week 4||-0.226|-0.287|<0.001
71778611|NCT01419626|143056949|SUPERIORITY||Difference in LS mean|-0.107|||<|0.001|TWO_SIDED|95.0|-0.137|-0.077|||ANCOVA|||Statistical analysis at Week 4||-0.077|-0.137|<0.001
71778612|NCT01419626|143056950|SUPERIORITY||Difference in LS mean|-0.362|||<|0.001|TWO_SIDED|95.0|-0.465|-0.259|||ANCOVA|||Statistical analysis at Week 2||-0.259|-0.465|<0.001
71665497|NCT03577301|142845180|SUPERIORITY||Wald Chi Square|0.64||||0.89|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 9 months.||||||0.89
71665498|NCT03577301|142845180|SUPERIORITY||Wald Chi Square|1.08||||0.78|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted marijuana use days at 12 months.||||||0.78
71745254|NCT02723773|143001588|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|86.96|||||TWO_SIDED|95.0|56.83|97.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of LTFU+Control \>=70 YOA Group over Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of PHN between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||97.49|56.83|
71745255|NCT02723773|143001589|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|89.69|||||TWO_SIDED|95.0|78.67|95.7|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||95.70|78.67|
71745256|NCT02723773|143001589|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|77.79|100.0|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 50-59 YOA Group over Placebo/Historical Control 50-59 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|77.79|
71745257|NCT02723773|143001589|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|74.75|||||TWO_SIDED|95.0|-155.17|99.49|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su 60-69 YOA Group over Placebo/Historical Control 60-69 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||99.49|-155.17|
71745258|NCT02723773|143001589|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|87.24|||||TWO_SIDED|95.0|73.29|94.72|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||94.72|73.29|
71745259|NCT02723773|143001589|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.08|||||TWO_SIDED|95.0|73.87|95.41|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against PHN in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of PHN between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||95.41|73.87|
71745260|NCT02723773|143001590|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|91.67|||||TWO_SIDED|95.0|43.68|99.81|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=50 YOA Group over Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=50 YOA Group and Historical Control \>=50 YOA Group.||99.81|43.68|
71745261|NCT02723773|143001590|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-247.21|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control 60-69YOA Group over Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control 60-69 YOA Group and Historical Control 60-69 YOA Group.||100.00|-247.21|
71745262|NCT02723773|143001590|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.91|||||TWO_SIDED|95.0|37.45|99.79|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=60YOA Group over Historical Control \>=60YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy in prevention of HZ related complications between LTFU+Control \>=60 YOA Group and Historical Control \>=60 YOA Group.||99.79|37.45|
71745263|NCT02723773|143001590|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|88.89|||||TWO_SIDED|95.0|19.81|99.75|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of LTFU+Control \>=70YOA Group over Historical Control \>=70YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between LTFU+Control \>=70 YOA Group and Historical Control \>=70 YOA Group.||99.75|19.81|
71665499|NCT03577301|142845181|SUPERIORITY||Wald Chi Square|2.37||||0.5|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 3 months.||||||0.50
71665500|NCT03577301|142845181|SUPERIORITY||Wald Chi Square|2.98||||0.34|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 6 months.||||||0.34
71665501|NCT03577301|142845181|SUPERIORITY||Wald Chi Square|1.59||||0.66|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 9 months.||||||0.66
71665502|NCT03577301|142845181|SUPERIORITY||Wald Chi Square|2.74||||0.43|TWO_SIDED||||||Negative Binomial Regression|Model testing whether condition predicted alcohol use days at 12 months.||||||0.43
71745264|NCT02723773|143001591|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.83|||||TWO_SIDED|95.0|71.57|99.17|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=50 YOA Group over Placebo/Historical Control \>=50 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=50 YOA Group and Placebo/Historical Control \>=50 YOA Group.||99.17|71.57|
71745265|NCT02723773|143001591|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|-1830.98|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 50-59YOA Group over Placebo/Historical Control 50-59YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 50-59 YOA Group and Placebo/Historical Control 50-59 YOA Group.||100.00|-1830.98|
71745266|NCT02723773|143001591|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|100.0|||||TWO_SIDED|95.0|17.55|100.0|||Poisson regression method||VE=1-RR. RR=the ratio of the incidence rates of HZ/su 60-69YOA Group over Placebo/Historical Control 60-69YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su 60-69 YOA Group and Placebo/Historical Control 60-69 YOA Group.||100.00|17.55|
71745267|NCT02723773|143001591|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|92.28|||||TWO_SIDED|95.0|69.17|99.11|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=60 YOA Group over Placebo/Historical Control \>=60 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=60 YOA Group and Placebo/Historical Control \>=60 YOA Group.||99.11|69.17|
71745268|NCT02723773|143001591|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|Vaccine efficacy|90.45|||||TWO_SIDED|95.0|60.93|98.91|||Poisson regression method||VE = 1 - RR. RR = the ratio of the incidence rates of HZ/su \>=70 YOA Group over Placebo/Historical Control \>=70 YOA Group. The VE of HZ/su vaccine against HZ related complications in this study was descriptively summarized by age strata and overall.|Comparison of vaccine efficacy (VE) in prevention of HZ related complications between HZ/su \>=70 YOA Group and Placebo/Historical Control \>=70 YOA Group.||98.91|60.93|
71745269|NCT03629886|143001616|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.15|||||TWO_SIDED|95.0|0.09|0.23||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=1963). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.23|0.09|
71745270|NCT03629886|143001616|OTHER|The IR (n/T) of incident cervical infection with HPV-16 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88|||||TWO_SIDED|95.0|0.73|1.05||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=1917). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.05|0.73|
71778613|NCT01419626|143056950|SUPERIORITY||Difference in LS mean|-0.534|||<|0.001|TWO_SIDED|95.0|-0.637|-0.431|||ANCOVA|||Statistical analysis at Week 2||-0.431|-0.637|<0.001
71778614|NCT01419626|143056950|SUPERIORITY||Difference in LS mean|-0.171||||0.001|TWO_SIDED|95.0|-0.273|-0.069|||ANCOVA|||Statistical analysis at Week 2||-0.069|-0.273|0.001
71778615|NCT01419626|143056951|SUPERIORITY||Difference in LS mean|-0.401|||<|0.001|TWO_SIDED|95.0|-0.51|-0.292|||ANCOVA|||Statistical analysis at Week 2||-0.292|-0.510|<0.001
71778616|NCT01419626|143056951|SUPERIORITY||Difference in LS mean|-0.558|||<|0.001|TWO_SIDED|95.0|-0.667|-0.449|||ANCOVA|||Statistical analysis at Week 2||-0.449|-0.667|<0.001
71778617|NCT01419626|143056951|SUPERIORITY||Difference in LS mean|-0.157|||<|0.001|TWO_SIDED|95.0|-0.265|-0.049|||ANCOVA|||Statistical analysis at Week 2||-0.049|-0.265|<0.001
71665503|NCT02661217|142845285|SUPERIORITY||Risk Ratio (RR)|0.896||||0.099|TWO_SIDED|95.0|0.786|1.021|||Cochran-Mantel-Haenszel|||||1.021|0.786|0.099
71665504|NCT02661217|142845286|SUPERIORITY||Risk Ratio (RR)|0.906||||0.034|TWO_SIDED|95.0|0.827|0.993|||Cochran-Mantel-Haenszel|||||0.993|0.827|0.034
71778618|NCT01419626|143056952|SUPERIORITY||Difference in LS mean|-0.03|||<|0.001|TWO_SIDED|95.0|-0.046|-0.014|||ANCOVA|||Statistical analysis at Week 2||-0.014|-0.046|<0.001
71778619|NCT01419626|143056952|SUPERIORITY||Difference in LS mean|-0.039|||<|0.001|TWO_SIDED|95.0|-0.055|-0.023|||ANCOVA|||Statistical analysis at Week 2||-0.023|-0.055|<0.001
71778620|NCT01419626|143056952|SUPERIORITY||Difference in LS mean|-0.009||||0.294|TWO_SIDED|95.0|-0.025|0.007|||ANCOVA|||Statistical analysis at Week 2||0.007|-0.025|0.294
71665505|NCT02661217|142845287|SUPERIORITY||Risk Ratio (RR)|0.96||||0.089|TWO_SIDED|95.0|0.916|1.006|||Cochran-Mantel-Haenszel|||||1.006|0.916|0.089
71745271|NCT03629886|143001616|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.09|||||TWO_SIDED|95.0|0.05|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2356). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.15|0.05|
71745272|NCT03629886|143001616|OTHER|The IR (n/T) of incident cervical infection with HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.44|||||TWO_SIDED|95.0|0.35|0.56||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2357). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.56|0.35|
71665506|NCT00711880|142845309|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.96||||0.004|TWO_SIDED|95.0|-1.59|-0.32|||ANCOVA|||The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.||-0.32|-1.59|0.004
71665507|NCT00711880|142845310|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-8.03||||0.007|TWO_SIDED|95.0|-13.83|-2.23|||ANCOVA|||The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.||-2.23|-13.83|0.007
71745273|NCT03629886|143001616|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|0.2|||||TWO_SIDED|95.0|0.14|0.27||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2534). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||0.27|0.14|
71745274|NCT03629886|143001616|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100 Person-years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2547). Those subjects were or were not enrolled in the current study, were HPV DNA negative and seronegative subjects at baseline and had cervical samples collected data.||1.18|0.88|
71745275|NCT03629886|143001617|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.19|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2818). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.19|
71745276|NCT03629886|143001617|OTHER|The IR (n/T) of incident cervical infection with HPV-16 and/or HPV-18 (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n), over the sum of follow-up period expressed in years (T), and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.21|||||TWO_SIDED|95.0|1.06|1.37||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of HPV-16/18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2815). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.37|1.06|
71745277|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.17|||||TWO_SIDED|95.0|0.11|0.24||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2718). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.24|0.11|
71745278|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2722). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.99|0.72|
71778621|NCT01419626|143056952|SUPERIORITY||Difference in LS mean|-0.019||||0.02|TWO_SIDED|95.0|-0.035|-0.003|||ANCOVA|||Statistical analysis at Week 4||-0.003|-0.035|0.020
71778622|NCT01419626|143056952|SUPERIORITY||Difference in LS mean|-0.034|||<|0.001|TWO_SIDED|95.0|-0.05|-0.018|||ANCOVA|||Statistical analysis at Week 4||-0.018|-0.050|<0.001
71665508|NCT00711880|142845311|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.43||||0.001|TWO_SIDED|95.0|-0.67|-0.19|||ANCOVA|||The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.||-0.19|-0.67|0.001
71745279|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.1|||||TWO_SIDED|95.0|0.06|0.15||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.15|0.06|
71745280|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.47||||||95.0|0.38|0.58||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-18 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2781). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.58|0.38|
71745281|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2786). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
71745282|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.48|||||TWO_SIDED|95.0|0.39|0.59||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2782). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.59|0.39|
71745283|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.25|||||TWO_SIDED|95.0|0.18|0.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.33|0.18|
71745284|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.41|||||TWO_SIDED|95.0|0.33|0.51||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-33 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2784). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.51|0.33|
71778623|NCT01419626|143056952|SUPERIORITY||Difference in LS mean|-0.015||||0.071|TWO_SIDED|95.0|-0.031|0.001|||ANCOVA|||Statistical analysis at Week 4||0.001|-0.031|0.071
71778624|NCT01419626|143056953|SUPERIORITY||Difference in LS mean|-0.067|||<|0.001||95.0|-0.083|-0.05|||ANCOVA|||Statistical analysis at Week 2||-0.050|-0.083|<0.001
71778625|NCT01419626|143056953|SUPERIORITY||Difference in LS mean|-0.083|||<|0.001|TWO_SIDED|95.0|-0.099|-0.066|||ANCOVA|||Statistical analysis at Week 2||-0.066|-0.099|<0.001
71778626|NCT01419626|143056953|SUPERIORITY||Difference in LS mean|-0.016||||0.057|TWO_SIDED|95.0|-0.032|0.0|||ANCOVA|||Statistical analysis at Week 2||0.000|-0.032|0.057
71778627|NCT01419626|143056953|SUPERIORITY||Difference in LS mean|-0.077|||<|0.001|TWO_SIDED|95.0|-0.095|-0.059|||ANCOVA|||Statistical analysis at Week 4||-0.059|-0.095|<0.001
71778628|NCT01419626|143056953|SUPERIORITY||Difference in LS mean|-0.101|||<|0.001|TWO_SIDED|95.0|-0.12|-0.083|||ANCOVA|||Statistical analysis at Week 4||-0.083|-0.120|<0.001
71778629|NCT01419626|143056953|SUPERIORITY||Difference in LS mean|-0.024||||0.009|TWO_SIDED|95.0|-0.042|-0.006|||ANCOVA|||Statistical analysis at Week 4||-0.006|-0.042|0.009
71665509|NCT00711880|142845312|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.85||||0.003|TWO_SIDED|95.0|-9.62|-2.09|||ANCOVA|||The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.||-2.09|-9.62|0.003
71665510|NCT00711880|142845313|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.82||||0.042|TWO_SIDED|95.0|-1.6|-0.03|||ANCOVA|||The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.||-0.03|-1.60|0.042
71778630|NCT01145625|143056959|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.|Mean Difference (Final Values)|-0.3||||0.917|TWO_SIDED|95.0|-6.0|5.4|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 24 data.||5.4|-6.0|0.9170
71778631|NCT01145625|143056960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||<|0.4158|TWO_SIDED|95.0|-3.4|8.2|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 12 data.||8.2|-3.4|<0.4158
71778632|NCT01145625|143056961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.598|TWO_SIDED|95.0|-7.1|4.1|||ANCOVA|P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 52 data.||4.1|-7.1|0.5980
71778633|NCT03080454|143056962|EQUIVALENCE|Statistical analysis for mean percent change from baseline in area under the curve for the resistance torque measure across 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean percent change in area under the curve between anodal and sham Doublestim conditions. A significance level of 0.05 was used (two-sided).||||||0.004||||||A 2x2 repeated measures ANOVA was performed with condition (mean percent change in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.004
71778634|NCT03080454|143056963|EQUIVALENCE|Statistical analysis for mean Tardieu Scale Score summed across 11 joints of the upper extremity in 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean change between anodal and sham Doubleestim conditions. A significance level of 0.05 was used (two-sided).||||||0.003||||||A 2x2 repeated measures ANOVA was performed with condition (mean score in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA|||||||0.003
71778635|NCT00216476|143056964|SUPERIORITY_OR_OTHER||||||<|0.0001||||||threshold for significance: 0.05 (2-sided)|Log Rank|||Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).||||<0.0001
71778636|NCT00216476|143056966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).||||<0.0001
71778637|NCT00216476|143056966|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
71778638|NCT00216476|143056966|SUPERIORITY_OR_OTHER|||||||0.1026|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.||||0.1026
71778639|NCT00216476|143056967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
71778640|NCT00216476|143056967|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||<0.0001
71778641|NCT00216476|143056967|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.||||0.0446
71778642|NCT00216476|143056968|SUPERIORITY_OR_OTHER|||||||0.0941|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.0941
71778643|NCT00216476|143056968|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
71778644|NCT00216476|143056968|SUPERIORITY_OR_OTHER|||||||0.1146|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.||||0.1146
71778645|NCT00216476|143056968|SUPERIORITY_OR_OTHER|||||||0.5589|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||0.5589
71665511|NCT00711880|142845314|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|12.73||||0.144|TWO_SIDED|95.0|-4.4|29.85|||ANCOVA|||The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.||29.85|-4.40|0.144
71665512|NCT00711880|142845315|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.75||||0.483|TWO_SIDED|95.0|-2.84|1.35|||ANCOVA|||The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.||1.35|-2.84|0.483
71778646|NCT00216476|143056968|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
71778647|NCT00216476|143056968|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.||||<0.0001
71778648|NCT00696800|143056988|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Treatment groups were formally compared with a generalized linear model for the ongoing pregnancy rate which included factors for treatment group, age at randomization, and region. A pre-defined non-inferiority margin of 8% was applied.|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-3.8|5.9||||||||5.9|-3.8|
71778649|NCT00696800|143056989|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in number of oocytes. If the 95% confidence interval of the difference exceeded -3 or +5 oocytes, then Corifollitropin Alfa treatment was not considered equivalent to the reference treatment (recFSH).|Mean Difference (Final Values)|1.2||||0.001|TWO_SIDED|95.0|0.5|1.9||Treatment groups were formally compared including covariates treatment group, age and center.|ANOVA|||||1.9|0.5|0.001
71778650|NCT03779711|143057015|SUPERIORITY|||||||0.8095|||||||ANCOVA|adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 3-months post-surgery.||||0.8095
71778651|NCT03779711|143057016|SUPERIORITY|||||||0.3029|||||||ANCOVA|Adjusted for baseline circumferential strain||Analysis of covariance (ANCOVA), adjusted for baseline circumferential strain, is used to assess change in circumferential strain from baseline to 3-months post-surgery.||||0.3029
71665513|NCT00711880|142845316|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.46|0.5|||ANCOVA|||The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.||0.50|-0.46|0.924
71665514|NCT00711880|142845317|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.53||||0.214|TWO_SIDED|95.0|-0.31|1.38|||ANCOVA|||The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.||1.38|-0.31|0.214
71665515|NCT00711880|142845318|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.15||||0.158|TWO_SIDED|95.0|-5.15|0.85|||ANCOVA|||The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.||0.85|-5.15|0.158
71665516|NCT00711880|142845319|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.28||||0.656|TWO_SIDED|95.0|-4.47|7.04|||ANCOVA|||The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.||7.04|-4.47|0.656
71778652|NCT03779711|143057017|SUPERIORITY|||||||0.0323|||||||ANCOVA|Adjusted for baseline longitudinal strain||Analysis of covariance (ANCOVA), adjusted for baseline longitudinal strain, is used to assess change in longitudinal strain from baseline to 3-months post-surgery.||||0.0323
71778653|NCT03779711|143057018|SUPERIORITY|||||||0.6765|||||||ANCOVA|Adjusted for baseline FAC.||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to 12-months post-surgery.||||0.6765
71778654|NCT03779711|143057019|SUPERIORITY|||||||0.3456|||||||ANCOVA|Adjusted for baseline FAC||Analysis of covariance (ANCOVA), adjusted for baseline FAC, is used to assess change in FAC from baseline to discharge.||||0.3456
71778655|NCT03779711|143057020|SUPERIORITY|||||||0.776|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery.||||0.7760
71778656|NCT03779711|143057021|SUPERIORITY|||||||0.9563|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in weight from baseline to 3-months post-surgery.||||0.9563
71778657|NCT03779711|143057022|SUPERIORITY|||||||0.9095|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in heart rate from baseline to 3-months post-surgery.||||0.9095
71778658|NCT03779711|143057023|SUPERIORITY|||||||0.6391|||||||Kruskal-Wallis|||Kruskal-Wallis test for change in oxygen saturation from baseline to 3-months post-surgery.||||0.6391
71778659|NCT03779711|143057030|SUPERIORITY|||||||0.8782|||||||Kruskal-Wallis|||Kruskal-Wallis test comparing number of days in hospital post stage-II surgery||||0.8782
71778660|NCT05224141|143057031|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.9762|TWO_SIDED|95.0|1.0|1.59|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.59|1.00|0.9762
71778661|NCT05224141|143057032|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5316|TWO_SIDED|95.0|0.82|1.23|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, LDH, liver metastasis, and brain metastasis.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||1.23|0.82|0.5316
71665517|NCT00711880|142845320|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.962|TWO_SIDED|95.0|-3.56|3.39|||ANCOVA|||The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.||3.39|-3.56|0.962
71665518|NCT00711880|142845321|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|32.26|||<|0.001|TWO_SIDED|95.0|16.4|48.12|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||48.12|16.40|<0.001
71778662|NCT05224141|143057033|SUPERIORITY||Percent Difference|-3.1|||||TWO_SIDED|95.0|-11.1|4.9|||||Based on Miettinen \& Nurminen method stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).|Statistical analyses stratified by ECOG performance status (0 vs. 1), LDH (≤ULN vs. \>ULN), liver metastasis (Yes or No), and brain metastasis (Yes or No).||4.9|-11.1|
71778663|NCT03469934|143057068|OTHER||Least Squares (LS) Mean Difference|-0.058||||0.5703|TWO_SIDED|95.0|-0.265|0.15|||Mixed-model repeated measures|||Mixed-model repeated measures (MMRM) analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.150|-0.265|0.5703
71778664|NCT03469934|143057072|OTHER||LS Mean Difference|-0.05||||0.5901|TWO_SIDED|95.0|-0.239|0.139|||Mixed-model repeated measures|||MMRM analysis with fixed terms for treatment, time point of measurement, and treatment by time point interaction, baseline eosinophil count as a covariate, and a repeated time point effect within a participant.||0.139|-0.239|0.5901
71778665|NCT03469934|143057073|OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.164||0.596|TWO_SIDED|95.0|-0.25|0.43|||ANCOVA|||Change from baseline for FEV1 was compared between etokimab and placebo using an analysis of covariance (ANCOVA) with treatment as fixed effect and baseline result as covariate and participant as a random effect||0.43|-0.25|0.5960
71665519|NCT00711880|142845323|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|29.03||||0.001||95.0|13.39|44.67|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups for each question, using Fisher's Exact Test.||44.67|13.39|0.001
71778666|NCT03469934|143057074|OTHER||LS Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|9.823||0.7993|TWO_SIDED|95.0|-17.9|22.96|||ANCOVA|||Change from baseline for FeNO was compared between etokimab and placebo using an ANCOVA with treatment as fixed effect and baseline result as covariate and participant as a random effect||22.96|-17.90|0.7993
71665520|NCT04238650|142845342|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.04|||||TWO_SIDED|90.0|0.981|1.11||||||||1.11|0.981|
71665521|NCT04238650|142845343|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25. The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.13|||||TWO_SIDED|90.0|1.03|1.24||||||||1.24|1.03|
71665522|NCT04238650|142845344|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25. The PK parameter AUClast was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate.|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.997|1.11||||||||1.11|0.997|
71665523|NCT02370238|142845429|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.589|TWO_SIDED|95.0|0.71|1.81||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.81|0.71|0.589
71665524|NCT02370238|142845430|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.897|TWO_SIDED|95.0|0.64|1.65||p-value based on a log-rank test stratified by randomized sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||1.65|0.64|0.897
71778667|NCT02068027|143057193|SUPERIORITY|||||||0.4503||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.4503
71778668|NCT02068027|143057194|SUPERIORITY|||||||0.735||||||MMRM imputing for missing data|Mixed Models Analysis|||||||0.7350
71778669|NCT01032174|143057195|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||<0.0001
71778670|NCT01032174|143057196|SUPERIORITY_OR_OTHER||Difference of Least Square Mean|1.06|STANDARD_ERROR_OF_MEAN|0.55||0.0568|TWO_SIDED|95.0|-0.03|2.15||The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).|ANCOVA|Least square mean was adjusted for gender, age and BMI.||||2.15|-0.03|0.0568
71778671|NCT01032174|143057197|SUPERIORITY_OR_OTHER|||||||0.0682|TWO_SIDED|||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic|||||||0.0682
71778672|NCT00113087|143057202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.28|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.28
71778673|NCT00113087|143057203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.42||95.0|||||Mixed Models Analysis|||||||0.42
71778674|NCT00113087|143057204|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
71778675|NCT00113087|143057205|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71778676|NCT00113087|143057206|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Fisher Exact|||||||0.71
71778677|NCT00113087|143057207|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.74
71778678|NCT00113087|143057208|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.22
71778679|NCT00113087|143057209|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||0.86
71778680|NCT00113087|143057210|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
71778681|NCT00113087|143057211|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
71778682|NCT00113087|143057212|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
71778683|NCT00113087|143057213|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|||||||0.008
71778684|NCT00113087|143057214|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71778685|NCT00113087|143057215|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
71778686|NCT00113087|143057216|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
71778687|NCT00113087|143057217|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||||||0.37
71778688|NCT00113087|143057218|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
71778689|NCT00113087|143057219|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
71778690|NCT00113087|143057220|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
71778691|NCT00113087|143057221|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||t-test, 2 sided|||||||0.11
71778692|NCT00113087|143057222|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
71778693|NCT00113087|143057223|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||t-test, 2 sided|||||||0.35
71665525|NCT02370238|142845431|SUPERIORITY||Odds Ratio (OR)|1.262||||0.667|TWO_SIDED|95.0|0.4909|3.963||P-value is based on Zelen's test for homogeneity of the odds ratios.|Zelen's test|||||3.963|0.4909|0.667
71778694|NCT00113087|143057224|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||||||0.62
71778695|NCT00113087|143057225|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
71778696|NCT00113087|143057226|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
71778697|NCT00113087|143057227|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||t-test, 2 sided|||||||0.34
71778698|NCT00113087|143057228|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||.81
71778699|NCT00113087|143057229|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Fisher Exact|||||||0.08
71778700|NCT00113087|143057230|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.06
71778701|NCT00810693|143057263|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant||||<0.0001
71778702|NCT00810693|143057263|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.78|||<|0.0001|TWO_SIDED|95.0|20.06|51.51||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||51.51|20.06|<0.0001
71778703|NCT00810693|143057263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71778704|NCT00810693|143057264|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
71778705|NCT00810693|143057264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-225.72|||<|0.0001|TWO_SIDED|95.0|-281.37|-170.08||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-170.08|-281.37|<0.0001
71778706|NCT00810693|143057264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71778707|NCT00810693|143057265|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.||||<0.0001
71778708|NCT00810693|143057265|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-431.81||||0.0157|TWO_SIDED|95.0|-781.52|-82.1||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-82.10|-781.52|0.0157
71778709|NCT00810693|143057265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71778710|NCT00810693|143057266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0033||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.||||0.0033
71778711|NCT00810693|143057267|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.2||||0.0046|TWO_SIDED|95.0|-9.85|-0.55||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region and therapy naive/add-on therapy|Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.|"The test is for difference of occurence of Any event."||-0.55|-9.85|0.0046
71834621|NCT00093015|143173700|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.12||||0.54||95.0|-0.51|0.26||Nominal p-value is from the term treatment group\*visit in the mixed model.|Mixed Models Analysis|Adjusted for baseline eGFR and the stratification factors of proteinuria and CVD history.|Estimated difference in rate of decline in eGFR per year between darbepoetin alfa and placebo.|||0.26|-0.51|0.54
71778712|NCT00810693|143057268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0022
71778713|NCT00810693|143057269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0663
71778714|NCT00810693|143057269|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.0197|TWO_SIDED|95.0|0.01|0.11||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||0.11|0.01|0.0197
71834622|NCT00093015|143173701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|0.35|<|0.001||95.0|0.64|2.02||Nominal p-value is presented.|t-test, 2 sided||Difference (darbepoetin alfa - placebo)|||2.02|0.64|<0.001
71665526|NCT02370238|142845433|SUPERIORITY|||||||0.767||||||For the All Patients group, p-value was based on a log-rank test stratified by actual sub-populations, newly diagnosed metastatic patients and patients that had relapsed following a prior (neo)adjuvant chemotherapy regimen.|Log Rank|||||||0.767
71778715|NCT00810693|143057269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71778716|NCT00810693|143057270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.||||0.0019
71778717|NCT00810693|143057270|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.17||||0.0009|TWO_SIDED|95.0|-9.79|-2.54||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA|||||-2.54|-9.79|0.0009
71778718|NCT00810693|143057270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.||||0.0001
71778719|NCT02149719|143057288|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71834623|NCT00093015|143173702|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.84||||0.4||95.0|0.55|1.27||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)|||1.27|0.55|0.40
71834624|NCT02885636|143173704|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
71665527|NCT02370238|142845434|SUPERIORITY||Odds Ratio (OR)|1.101||||0.667|TWO_SIDED|95.0|0.437|2.79||P-value was based on Zelen's test for homogeneity of the odds ratios|Zelen's test|||||2.790|0.437|0.667
71778720|NCT00516074|143057330|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.||||||0.1585||95.0|||||ANCOVA|||||||0.1585
71778721|NCT00516074|143057331|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.1624||95.0|||||ANCOVA|||||||0.1624
71665528|NCT01569295|142845464|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.27|0.45|||Stratified log-rank test||Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.|||0.45|0.27|< 0.0001
71665529|NCT01569295|142845465|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|1.98|4.62||Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).|Cochran-Mantel-Haenszel|||||4.62|1.98|<0.0001
71665530|NCT01569295|142845466|SUPERIORITY||Odds Ratio (OR)|28.81|||<|0.0001|TWO_SIDED|95.0|10.5|79.02||Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||79.02|10.50|<0.0001
71778722|NCT00516074|143057332|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.5077||95.0|||||ANCOVA|||||||0.5077
71778723|NCT00516074|143057333|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.9034||95.0|||||ANCOVA|||||||0.9034
71778724|NCT00516074|143057334|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.427||95.0|||||ANCOVA|||||||0.4270
71665531|NCT01569295|142845467|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.098|TWO_SIDED|95.0|0.59|1.03|||Stratified log-rank test|||||1.03|0.59|0.098
71665532|NCT01569295|142845468|SUPERIORITY||Odds Ratio (OR)|9.55||||0.011|TWO_SIDED|95.0|1.19|76.81||Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel|||||76.81|1.19|0.011
71778725|NCT00516074|143057335|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.26||95.0|||||ANCOVA|||||||0.2600
71778726|NCT02298023|143057378|OTHER|||||||0.35|||||||Kruskal-Wallis|||Null hypothesis: There is no difference between the three groups. Statistical power: 0.80||||0.35
71778727|NCT02298023|143057379|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.662|||||||Mixed Models Analysis|||||||0.662
71778728|NCT02298023|143057380|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.882|||||||Mixed Models Analysis|||||||0.882
71665533|NCT00428116|142845484|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||WAZ-score comparison at 18 months||||0.15
71665534|NCT00428116|142845484|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||HAZ score at 18 months||||0.45
71665535|NCT00428116|142845485|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||log rank or Cox regression|incidence with Cox regression utilized Anderson-Gill method to handle recurrent events||SAEs||||0.39
71665536|NCT00428116|142845485|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Cox regression Anderson Gill|||Pneumonia||||0.60
71665537|NCT00428116|142845485|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Regression, Cox|||Pneumonia||||0.60
71778729|NCT02298023|143057381|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.835|||||||Mixed Models Analysis|||||||0.835
71778730|NCT02298023|143057382|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.977|||||||Mixed Models Analysis|||||||0.977
71778731|NCT02298023|143057383|EQUIVALENCE|To test whether there were differences in the rate of change among groups||||||0.867|||||||Mixed Models Analysis|||||||0.867
71778732|NCT02298023|143057384|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.916|||||||Chi-squared|||||||0.916
71665538|NCT00428116|142845485|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Regression, Cox|||Diarrhea||||0.77
71665539|NCT00428116|142845485|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Log Rank|||Death||||0.29
71665540|NCT01044264|142845495|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|BE of the test to reference in the per protocol population|Wilcoxon Rank Sum Test|100.0|||||TWO_SIDED|90.0|92.47|113.54|||Wilcoxon Rank Sum Test|||||113.54|92.47|
71665541|NCT03901092|142845512|OTHER||Fleiss' kappa|0.87|||||TWO_SIDED|95.0|0.83|0.91||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.91|0.83|
71778733|NCT02298023|143057385|EQUIVALENCE|To test whether there were differences in the change of tear size among groups||||||0.892|||||||Chi-squared|||||||0.892
71778734|NCT00843856|143057405|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.7
71778735|NCT01893203|143057407|SUPERIORITY_OR_OTHER|||||||0.375|||||||McNemar|||||||0.375
71778736|NCT04729621|143057411|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45).|Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.73|1.15||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption.||1.15|-0.73|
71834625|NCT02885636|143173705|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71834626|NCT02885636|143173706|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71834627|NCT02885636|143173707|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.9
71834628|NCT02885636|143173708|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71834629|NCT02885636|143173709|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71665542|NCT03901092|142845515|OTHER||Fleiss' kappa|0.84|||||TWO_SIDED|95.0|0.8|0.88||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The primary hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.88|0.80|
71665543|NCT03901092|142845516|OTHER||Fleiss' kappa|0.9|||||TWO_SIDED|95.0|0.85|0.95||||||Fleiss' kappa is a statistical measure for assessing the reliability of agreement between a fixed number of raters when assigning categorical ratings to a number of items or classifying items. The hypothesis to be tested was that the lower bound of two-sided 95% confidence interval of Fleiss' Kappa will be greater than or equal to 0.6.||0.95|0.85|
71665544|NCT03901092|142845517|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.69|1.0||||||Cohen's kappa statistic for Reader 1||1.00|0.69|
71665545|NCT03901092|142845517|OTHER||Cohen's kappa|0.71|||||TWO_SIDED|95.0|0.41|1.0||||||Cohen's kappa statistic for Reader 2||1.00|0.41|
71778737|NCT04729621|143057412|EQUIVALENCE|Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-20, +20).|Mean Difference (Net)|9.07|||||TWO_SIDED|95.0|-0.14|18.29||||||LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 26 in sCTX-1 as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline sCTX-1 and baseline weight as covariates. Missing outcomes are not imputed. Results below the limit of quantification (BLQ) are imputed as the low limit of quantification (LLOQ = 0.033 ng/mL).||18.29|-0.14|
71834630|NCT02885636|143173710|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71834631|NCT02885636|143173711|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71834632|NCT02885636|143173712|SUPERIORITY|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71665546|NCT03901092|142845517|OTHER||Cohen's kappa|0.6|||||TWO_SIDED|95.0|0.24|0.95||||||Cohen's kappa statistic for Reader 3||0.95|0.24|
71778738|NCT01999868|143057446|SUPERIORITY|||||||0.41||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.||||0.41
71778739|NCT01999868|143057446|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.013
71665547|NCT03901092|142845517|OTHER||Cohen's kappa|0.89|||||TWO_SIDED|95.0|0.67|1.0||||||Cohen's kappa statistic for Reader 4||1.00|0.67|
71665548|NCT03901092|142845517|OTHER||Cohen's kappa|0.79|||||TWO_SIDED|95.0|0.52|1.0||||||Cohen's kappa statistic for Reader 5||1.00|0.52|
71665549|NCT03837743|142845518|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.42||0.022|TWO_SIDED||||||Paired t-test|||Difference in Change (week 4)||||0.022
71778740|NCT01999868|143057446|SUPERIORITY|||||||0.5||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.50
71778741|NCT01999868|143057446|SUPERIORITY|||||||0.67||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.67
71778742|NCT01999868|143057447|SUPERIORITY|||||||0.019||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.019
71778743|NCT01999868|143057447|SUPERIORITY|||||||0.001||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
71834633|NCT02885636|143173713|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71834634|NCT02885636|143173714|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71834635|NCT02885636|143173715|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71834636|NCT02885636|143173716|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71665550|NCT03837743|142845518|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.8||0.296|TWO_SIDED||||||Paired t-test|||Difference in Change (week 8)||||0.296
71665551|NCT00086281|142845549|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||ANOVA on ranks|||||||0.009
71665552|NCT00086281|142845549|SUPERIORITY_OR_OTHER|||||||0.0244||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0244
71665553|NCT00086281|142845549|SUPERIORITY_OR_OTHER|||||||0.0119||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.0119
71665554|NCT00086281|142845549|SUPERIORITY_OR_OTHER|||||||0.5055||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.5055
71665555|NCT00086281|142845549|SUPERIORITY_OR_OTHER|||||||0.3132||95.0||||Bonferroni adjusted P-Value|ANOVA on ranks|||||||0.3132
71834637|NCT02885636|143173717|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71834638|NCT02794480|143173718|SUPERIORITY||||||<|0.001||||||ELLIPTA versus GSK MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||<0.001
71834639|NCT02794480|143173718|SUPERIORITY|||||||0.007||||||ELLIPTA versus AZ MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.|||0.007
71834640|NCT02794480|143173723|SUPERIORITY||Odds Ratio (OR)|5.94|||<|0.001|TWO_SIDED|95.0|2.42||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus GSK MDI||||2.42|<0.001
71834641|NCT02794480|143173723|SUPERIORITY||Odds Ratio (OR)|4.16||||0.011|TWO_SIDED|95.0|1.59||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus AZ MDI||||1.59|0.011
71778744|NCT01999868|143057447|SUPERIORITY|||||||0.018||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.018
71778745|NCT01999868|143057447|SUPERIORITY|||||||0.07||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.07
71778746|NCT01999868|143057448|SUPERIORITY|||||||0.16||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.16
71778747|NCT01999868|143057448|SUPERIORITY|||||||0.002||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.002
71778748|NCT01999868|143057448|SUPERIORITY|||||||0.23||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.||||0.23
71778749|NCT01999868|143057448|SUPERIORITY|||||||0.43||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.||||0.43
71778750|NCT01999868|143057449|SUPERIORITY|||||||0.06||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.06
71778751|NCT01999868|143057449|SUPERIORITY|||||||0.008||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.008
71778752|NCT01999868|143057450|SUPERIORITY|||||||0.005||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.||||0.005
71778753|NCT01999868|143057450|SUPERIORITY|||||||0.001||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.||||0.001
71778754|NCT01999868|143057451|SUPERIORITY|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40||||0.013
71778755|NCT01999868|143057451|SUPERIORITY|||||||0.95|||||||Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or \>20) and duration of disease prior to screening, centered about the median, are covariates.||Week 88||||0.95
71778756|NCT01999868|143057452|SUPERIORITY|||||||0.18||||||Two-sided test.|ANCOVA|Randomization stratum (PASI score at week 0: 12-20 or \>20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.||Week 12 to 40||||0.18
71778757|NCT01999868|143057452|SUPERIORITY|||||||0.045||||||Two-sided test.|ANCOVA|Randomization (PASI score week 0:12-20 or \>20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates||Week 12 to 88||||0.045
71778758|NCT00310401|143057457|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Paired T Test|||Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors||||0.98
71778759|NCT03572972|143057463|SUPERIORITY||Hazard Ratio (HR)|0.618|||||TWO_SIDED|95.0|0.541|0.707||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of hazard ratio (HR) at year 1 as an extended Cox model was used.||0.707|0.541|
71778760|NCT03572972|143057463|SUPERIORITY||Hazard Ratio (HR)|0.604|||||TWO_SIDED|95.0|0.53|0.687||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.687|0.530|
71778761|NCT03572972|143057463|SUPERIORITY||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.563|0.884|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.884|0.563|
71778762|NCT03572972|143057464|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.87|1.134||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.134|0.870|
71677372|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.673|||||TWO_SIDED|95.0|0.509|0.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.889|0.509|
71834642|NCT01017146|143173724|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
71665556|NCT03390426|142845570|SUPERIORITY|"this is a superiority study and the non-inferiority or equivalence analysis is not required"|||||<|0.05||||||Comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.|t-test, 2 sided|Comparisons were made using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables.||We determined 30 subjects were needed to detect a 50% difference in THN incidence between the two groups using a one-sided Fisher's exact test with alpha = 0.05 and 80% power while allowing up to 20% drop-out. For primary and secondary outcomes, comparisons were made between the two groups using a two-sample t-test or Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables. p-value of \<0.05 was considered to be statistically significant.||||<0.05
71665557|NCT02924727|142845603|SUPERIORITY||Hazard Ratio (HR)|0.9012||||0.1659|TWO_SIDED|95.0|0.7778|1.0441|||Cox's Proportional Hazard Model|||Primary Composite||1.0441|0.7778|0.1659
71665558|NCT02924727|142845603|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.2031|TWO_SIDED|95.0|0.7104|1.0754|||Cox's Proportional Hazard Model|||CV Death||1.0754|0.7104|0.2031
71665559|NCT02924727|142845603|SUPERIORITY||Hazard Ratio (HR)|0.8653||||0.1679|TWO_SIDED|95.0|0.7044|1.0629|||Cox's Proportional Hazard Model|||First HF Hospitalization||1.0629|0.7044|0.1679
71665560|NCT02924727|142845603|SUPERIORITY||Hazard Ratio (HR)|0.6831||||0.0667|TWO_SIDED|95.0|0.4546|1.0266|||Cox's Proportional Hazard Model|||First Outpatient HF||1.0266|0.4546|0.0667
71665561|NCT02924727|142845604|SUPERIORITY||Hazard Ratio (HR)|0.9133||||0.2507|TWO_SIDED|95.0|0.7824|1.0662|||Cox's Proportional Hazard Model|||CV death or HF hospitalization||1.0662|0.7824|0.2507
71665562|NCT02924727|142845605|SUPERIORITY||Hazard Ratio (HR)|0.8422||||0.0732|TWO_SIDED|95.0|0.6979|1.0163|||Cox's Proportional Hazard Model|||HF hospitalization or Outpatient HF||1.0163|0.6979|0.0732
71665563|NCT02924727|142845606|SUPERIORITY||Hazard Ratio (HR)|0.9007||||0.1785|TWO_SIDED|95.0|0.7734|1.0489|||Cox's Proportional Hazard Model|||CV death, Non-fatal spontaneous MI or Non-fatal stroke||1.0489|0.7734|0.1785
71665564|NCT02924727|142845607|SUPERIORITY||Rate Ratio|0.8361||||0.0452|TWO_SIDED|95.0|0.7018|0.9961|||Negative Binomial regression model|||Total Number of Confirmed Composite Endpoints||0.9961|0.7018|0.0452
71665565|NCT02924727|142845608|SUPERIORITY||Hazard Ratio (HR)|0.8751||||0.1556|TWO_SIDED|95.0|0.7279|1.052|||Cox's Proportional Hazard Model|||All-Cause Death||1.0520|0.7279|0.1556
71665566|NCT04102189|142845613|SUPERIORITY||Treatment difference|-16.75|||<|0.0001|TWO_SIDED|95.0|-20.27|-13.23|||ANCOVA|||Responses were analyzed using an analysis of covariance model with randomized treatment, stratification groups (sex and Tanner stage at baseline) and the interaction between stratification groups as factors and baseline BMI as covariate.||-13.23|-20.27|<.0001
71665567|NCT02933255|142845656|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD8+T cell infiltration within the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
71665568|NCT02933255|142845656|OTHER|||||||0.04||||||The reported p-value is representative of changes in CD8+T cell infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.04
71665569|NCT02933255|142845656|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD8+T cell infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
71665570|NCT02933255|142845656|OTHER|||||||0.46||||||The reported p-value is representative of changes in CD8+T cell infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.46
71665571|NCT02933255|142845656|OTHER||||||<|0.0001||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the total tissue at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||<0.0001
71665572|NCT02933255|142845656|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the center of the tumor at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.016
71665573|NCT02933255|142845656|OTHER|||||||0.002||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the invasive margin at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.002
71665574|NCT02933255|142845656|OTHER|||||||0.38||||||The reported p-value is representative of changes in CD4 T cell helper infiltration in the normal region at time of prostatectomy compared to baseline.|Wilcoxon Signed Rank Test|||||||0.38
71665575|NCT02933255|142845658|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.||||||0.064|||||||Wilcoxon Signed Rank Test|||||||0.064
71665576|NCT02933255|142845658|OTHER|The reported p-value is representative of changes in soluble factors at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.||||||0.001|||||||Wilcoxon Signed Rank Test|||||||0.001
71665577|NCT02933255|142845658|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.003
71665578|NCT02933255|142845658|OTHER|||||||0.003||||||The reported p-value is representative of changes in soluble factors at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.003
71665579|NCT02933255|142845658|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
71665580|NCT02933255|142845658|OTHER|||||||0.004||||||The reported p-value is representative of changes in soluble factors at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.004
71665581|NCT02933255|142845659|OTHER|||||||0.002||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.002
71665582|NCT02933255|142845659|OTHER|||||||0.042||||||The reported p-value is representative of changes in TNFα at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
71665583|NCT02933255|142845659|OTHER|||||||0.233||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.233
71665584|NCT02933255|142845659|OTHER|||||||0.052||||||The reported p-value is representative of changes in TNFα at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.052
71665585|NCT02933255|142845659|OTHER|||||||0.055||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.055
71665586|NCT02933255|142845659|OTHER|||||||0.203||||||The reported p-value is representative of changes in TNFα at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.203
71665587|NCT02933255|142845659|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71665588|NCT02933255|142845659|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 4 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
71665589|NCT02933255|142845659|OTHER||||||<|0.001||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71665590|NCT02933255|142845659|OTHER|||||||0.034||||||The reported p-value is representative of changes in IL-10 at 10 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.034
71665591|NCT02933255|142845659|OTHER|||||||0.004||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the lead-in metastatic castration-resistant prostate cancer (mCRPC) cohort.|Wilcoxon Signed Rank Test|||||||0.004
71665592|NCT02933255|142845659|OTHER|||||||0.129||||||The reported p-value is representative of changes in IL-10 at 20 weeks of therapy compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.129
71665593|NCT02933255|142845661|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
71665594|NCT02933255|142845661|OTHER|||||||0.037||||||The reported p-value is representative of changes in CD4+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.037
71665595|NCT02933255|142845661|OTHER|||||||0.009||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.009
71665596|NCT02933255|142845661|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
71665597|NCT02933255|142845661|OTHER|||||||0.204||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.204
71665598|NCT02933255|142845661|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
71665599|NCT02933255|142845661|OTHER|||||||0.042||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.042
71665600|NCT02933255|142845661|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
71665601|NCT02933255|142845661|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71665602|NCT02933255|142845661|OTHER|||||||0.733||||||The reported p-value is representative of changes in Treg cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
71665603|NCT02933255|142845661|OTHER|||||||0.519||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
71665604|NCT02933255|142845661|OTHER|||||||0.695||||||The reported p-value is representative of changes in Treg cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.695
71665605|NCT02933255|142845661|OTHER|||||||0.034||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
71665606|NCT02933255|142845661|OTHER|||||||0.301||||||The reported p-value is representative of changes in cDC cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.301
71665607|NCT02933255|142845661|OTHER|||||||0.38||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
71665608|NCT02933255|142845661|OTHER|||||||0.014||||||The reported p-value is representative of changes in cDC cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.014
71665609|NCT02933255|142845661|OTHER|||||||0.791||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.791
71665610|NCT02933255|142845661|OTHER|||||||0.042||||||The reported p-value is representative of changes in monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
71665611|NCT02933255|142845661|OTHER|||||||0.424||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71665612|NCT02933255|142845661|OTHER|||||||0.77||||||The reported p-value is representative of changes in monocytes at week 10 post treatment compared to baseline in the lead-in neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.77
71834643|NCT01017146|143173724|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
71745285|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.3|||||TWO_SIDED|95.0|0.23|0.39||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2806). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.39|0.23|
71665613|NCT02933255|142845661|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
71665614|NCT02933255|142845661|OTHER|||||||0.105||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
71745286|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.46||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-35 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2803). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.46|0.28|
71834644|NCT01017146|143173724|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
71834645|NCT01017146|143173725|SUPERIORITY_OR_OTHER||Percentage of participants|35.6|||<|0.001|TWO_SIDED|95.0|30.7|40.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||40.5|30.7|<0.001
71665615|NCT02933255|142845661|OTHER|||||||0.622||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
71745287|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.88||||||95.0|0.75|1.02||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2759). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.02|0.75|
71745288|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-39 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2773). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.93|0.67|
71745289|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.11|||||TWO_SIDED|95.0|0.07|0.16||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2794). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.16|0.07|
71758521|NCT02205736|143019221|SUPERIORITY|||||||0.0124||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0124
71834646|NCT01017146|143173725|SUPERIORITY_OR_OTHER||Percentage of participants|23.9|||||TWO_SIDED|95.0|19.6|28.3|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||28.3|19.6|
71834647|NCT01017146|143173726|SUPERIORITY_OR_OTHER||Percentage of participants|28.8|||<|0.001|TWO_SIDED|95.0|24.2|33.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||33.5|24.2|<0.001
71665616|NCT02933255|142845661|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
71745290|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.21|||||TWO_SIDED|95.0|0.15|0.28||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N= 2802). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.28|0.15|
71745291|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2753). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.18|0.88|
71745292|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.18|||||TWO_SIDED|95.0|1.03|1.34||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-51 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2756). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.34|1.03|
71745293|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.67|||||TWO_SIDED|95.0|1.48|1.87||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2666). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.87|1.48|
71778763|NCT03572972|143057464|SUPERIORITY||Hazard Ratio (HR)|0.949|||||TWO_SIDED|95.0|0.839|1.073||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.073|0.839|
71778764|NCT03572972|143057464|SUPERIORITY||Hazard Ratio (HR)|0.961|||||TWO_SIDED|95.0|0.854|1.082||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.082|0.854|
71778765|NCT03572972|143057465|SUPERIORITY||Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.512|0.664||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.664|0.512|
71778766|NCT03572972|143057465|SUPERIORITY||Hazard Ratio (HR)|0.754|||||TWO_SIDED|95.0|0.597|0.953|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.953|0.597|
71834648|NCT01017146|143173726|SUPERIORITY_OR_OTHER||Percentage of participants|16.1|||||TWO_SIDED|95.0|12.4|19.9|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||19.9|12.4|
71834649|NCT01172418|143173742|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
71834650|NCT01172418|143173743|SUPERIORITY|||||||0.37|||||||Log Rank|||||||0.37
71834651|NCT01172418|143173744|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
71665617|NCT02933255|142845661|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71665618|NCT02933255|142845661|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
71665619|NCT02933255|142845661|OTHER|||||||0.47||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.47
71665620|NCT02933255|142845661|OTHER|||||||0.313||||||The reported p-value is representative of changes in CD4+ EM ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.313
71665621|NCT02933255|142845661|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
71665622|NCT02933255|142845661|OTHER|||||||0.092||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
71665623|NCT02933255|142845661|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
71665624|NCT02933255|142845661|OTHER|||||||0.232||||||The reported p-value is representative of changes in CD4+ ICOS+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.232
71665625|NCT02933255|142845661|OTHER||||||<|0.001||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71665626|NCT02933255|142845661|OTHER|||||||0.131||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.131
71665627|NCT02933255|142845661|OTHER|||||||0.424||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71665628|NCT02933255|142845661|OTHER|||||||0.438||||||The reported p-value is representative of changes in CD8+ ki67+ T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.438
71778767|NCT03572972|143057465|SUPERIORITY||Hazard Ratio (HR)|0.844|||||TWO_SIDED|95.0|0.685|1.04|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.040|0.685|
71778768|NCT03572972|143057466|SUPERIORITY||Hazard Ratio (HR)|0.866|||||TWO_SIDED|95.0|0.761|0.985||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.985|0.761|
71778769|NCT03572972|143057466|SUPERIORITY||Hazard Ratio (HR)|0.768|||||TWO_SIDED|95.0|0.684|0.862||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.862|0.684|
71778770|NCT03572972|143057466|SUPERIORITY||Hazard Ratio (HR)|0.875|||||TWO_SIDED|95.0|0.786|0.975||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.975|0.786|
71834652|NCT01172418|143173745|SUPERIORITY|||||||0.25|||||||Log Rank|||||||0.25
71665629|NCT02933255|142845661|OTHER||||||<|0.001||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||<0.001
71665630|NCT02933255|142845661|OTHER|||||||0.151||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.151
71665631|NCT02933255|142845661|OTHER|||||||0.569||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.569
71665632|NCT02933255|142845661|OTHER|||||||0.105||||||The reported p-value is representative of changes in Treg ICOS+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.105
71665633|NCT02933255|142845661|OTHER|||||||0.012||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
71665634|NCT02933255|142845661|OTHER|||||||0.677||||||The reported p-value is representative of changes in NK ki67+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.677
71665635|NCT02933255|142845661|OTHER|||||||0.424||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71665636|NCT02933255|142845661|OTHER|||||||0.432||||||The reported p-value is representative of changes in NK ki67+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.432
71665637|NCT02933255|142845661|OTHER|||||||0.016||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
71778771|NCT03572972|143057467|SUPERIORITY||Hazard Ratio (HR)|0.673|||||TWO_SIDED|95.0|0.47|0.964||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.964|0.470|
71665638|NCT02933255|142845661|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.733
71665639|NCT02933255|142845661|OTHER|||||||0.519||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.519
71778772|NCT03572972|143057467|SUPERIORITY||Hazard Ratio (HR)|0.491|||||TWO_SIDED|95.0|0.337|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.337|
71778773|NCT03572972|143057467|SUPERIORITY||Hazard Ratio (HR)|0.747|||||TWO_SIDED|95.0|0.548|1.018||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.018|0.548|
71778774|NCT03572972|143057468|SUPERIORITY||Hazard Ratio (HR)|1.463|||||TWO_SIDED|95.0|0.998|2.145||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||2.145|0.998|
71778775|NCT03572972|143057468|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.647|1.225||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.225|0.647|
71778776|NCT03572972|143057468|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.447|0.888||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.888|0.447|
71778777|NCT03572972|143057469|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.556|0.738||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.738|0.556|
71778778|NCT03572972|143057469|SUPERIORITY||Hazard Ratio (HR)|0.624|||||TWO_SIDED|95.0|0.544|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.715|0.544|
71778779|NCT03572972|143057469|SUPERIORITY||Hazard Ratio (HR)|0.749|||||TWO_SIDED|95.0|0.588|0.954|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.954|0.588|
71665640|NCT02933255|142845661|OTHER|||||||0.557||||||The reported p-value is representative of changes in NK NKG2D+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.557
71778780|NCT03572972|143057470|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.85|1.122||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.122|0.850|
71834653|NCT02538341|143173762|OTHER|||||||0.0023||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p value,from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.0023
71665641|NCT02933255|142845661|OTHER|||||||0.034||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.034
71665642|NCT02933255|142845661|OTHER|||||||0.092||||||The reported p-value is representative of changes in NK NKp46+ cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.092
71665643|NCT02933255|142845661|OTHER|||||||0.733||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.733
71665644|NCT02933255|142845661|OTHER|||||||0.922||||||The reported p-value is representative of changes in NK NKp46+ cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.922
71665645|NCT02933255|142845661|OTHER|||||||0.176||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.176
71665646|NCT02933255|142845661|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD8+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
71778781|NCT03572972|143057470|SUPERIORITY||Hazard Ratio (HR)|0.966|||||TWO_SIDED|95.0|0.848|1.1||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.100|0.848|
71778782|NCT03572972|143057470|SUPERIORITY||Hazard Ratio (HR)|0.993|||||TWO_SIDED|95.0|0.877|1.125||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.125|0.877|
71778783|NCT03572972|143057471|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.119|0.523||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.523|0.119|
71778784|NCT03572972|143057471|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.203|0.711||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.711|0.203|
71778785|NCT03572972|143057471|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.247|0.722||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.722|0.247|
71778786|NCT03572972|143057472|SUPERIORITY||Hazard Ratio (HR)|0.745|||||TWO_SIDED|95.0|0.343|1.615||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.615|0.343|
71778787|NCT03572972|143057472|SUPERIORITY||Hazard Ratio (HR)|0.692|||||TWO_SIDED|95.0|0.342|1.402||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.402|0.342|
71778788|NCT03572972|143057472|SUPERIORITY||Hazard Ratio (HR)|0.932|||||TWO_SIDED|95.0|0.498|1.747||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.747|0.498|
71778789|NCT03572972|143057473|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.492|0.731||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.731|0.492|
71778790|NCT03572972|143057473|SUPERIORITY||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.719|1.522|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.522|0.719|
71665647|NCT02933255|142845661|OTHER|||||||0.001||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.001
71665648|NCT02933255|142845661|OTHER|||||||0.563||||||The reported p-value is representative of changes in CD8+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.563
71665649|NCT02933255|142845661|OTHER|||||||0.012||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.012
71665650|NCT02933255|142845661|OTHER|||||||0.084||||||The reported p-value is representative of changes in CD8+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
71665651|NCT02933255|142845661|OTHER|||||||0.016||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.016
71778791|NCT03572972|143057473|SUPERIORITY||Hazard Ratio (HR)|1.295|||||TWO_SIDED|95.0|0.92|1.824|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.824|0.920|
71778792|NCT03572972|143057474|SUPERIORITY||Hazard Ratio (HR)|0.751|||||TWO_SIDED|95.0|0.62|0.91||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.91|0.62|
71665652|NCT02933255|142845661|OTHER|||||||0.688||||||The reported p-value is representative of changes in CD8+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.688
71665653|NCT02933255|142845661|OTHER|||||||0.38||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.38
71665654|NCT02933255|142845661|OTHER|||||||0.021||||||The reported p-value is representative of changes in gMDSC at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.021
71665655|NCT02933255|142845661|OTHER|||||||0.91||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.91
71665656|NCT02933255|142845661|OTHER|||||||0.084||||||The reported p-value is representative of changes in gMDSC at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.084
71665657|NCT02933255|142845661|OTHER|||||||0.151||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.151
71665658|NCT02933255|142845661|OTHER|||||||0.042||||||The reported p-value is representative of changes in intermediate monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.042
71778793|NCT03572972|143057474|SUPERIORITY||Hazard Ratio (HR)|0.697|||||TWO_SIDED|95.0|0.586|0.83||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.830|0.586|
71665659|NCT02933255|142845661|OTHER|||||||0.424||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.424
71665660|NCT02933255|142845661|OTHER|||||||0.846||||||The reported p-value is representative of changes in intermediate monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.846
71665661|NCT02933255|142845661|OTHER|||||||0.339||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
71778794|NCT03572972|143057474|SUPERIORITY||Hazard Ratio (HR)|0.936|||||TWO_SIDED|95.0|0.801|1.094||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.094|0.801|
71665662|NCT02933255|142845661|OTHER|||||||0.012||||||The reported p-value is representative of changes in non-classical monocytes at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.012
71665663|NCT02933255|142845661|OTHER|||||||0.622||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.622
71665664|NCT02933255|142845661|OTHER|||||||0.492||||||The reported p-value is representative of changes in non-classical monocytes at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.492
71665665|NCT02933255|142845661|OTHER|||||||0.11||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.11
71665666|NCT02933255|142845661|OTHER|||||||0.02||||||The reported p-value is representative of changes in CD4+ CM T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.02
71665667|NCT02933255|142845661|OTHER|||||||0.052||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.052
71665668|NCT02933255|142845661|OTHER|||||||0.844||||||The reported p-value is representative of changes in CD4+ CM T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.844
71665669|NCT02933255|142845661|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||>0.999
71745294|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|1.8|||||TWO_SIDED|95.0|1.61|2.0||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-52 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2663). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.00|1.61|
71745295|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.61|||||TWO_SIDED|95.0|0.5|0.73||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2783). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.73|0.50|
71745296|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.53|0.76||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-56 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.76|0.53|
71778795|NCT03572972|143057475|SUPERIORITY||Hazard Ratio (HR)|0.373|||||TWO_SIDED|95.0|0.212|0.658|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.658|0.212|
71745297|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.51|||||TWO_SIDED|95.0|0.42|0.62||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2772). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.62|0.42|
71745298|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.65||||||95.0|0.55|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-58 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2768). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.55|
71745299|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.31|||||TWO_SIDED|95.0|0.24|0.4||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2814). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.40|0.24|
71665670|NCT02933255|142845661|OTHER|||||||0.049||||||The reported p-value is representative of changes in CD4+ naive T cells at week 4 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||0.049
71778796|NCT03572972|143057475|SUPERIORITY||Hazard Ratio (HR)|0.538|||||TWO_SIDED|95.0|0.392|0.737||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.737|0.392|
71665671|NCT02933255|142845661|OTHER|||||||0.339||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the lead-in metastatic castration-resistant prostate cancer cohort.|Wilcoxon Signed Rank Test|||||||0.339
71745300|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.36|||||TWO_SIDED|95.0|0.28|0.45||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-59 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2797). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.45|0.28|
71745301|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.62|||||TWO_SIDED|95.0|0.51|0.74||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2779). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.74|0.51|
71778797|NCT03572972|143057475|SUPERIORITY||Hazard Ratio (HR)|0.664|||||TWO_SIDED|95.0|0.507|0.87||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.870|0.507|
71778798|NCT03572972|143057476|SUPERIORITY||Hazard Ratio (HR)|1.204|||||TWO_SIDED|95.0|0.871|1.666||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.666|0.871|
71778799|NCT03572972|143057476|SUPERIORITY||Hazard Ratio (HR)|0.918|||||TWO_SIDED|95.0|0.691|1.218||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.218|0.691|
71745302|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-66 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2763). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.77|0.54|
71745303|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.56||||||95.0|0.46|0.68||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2775). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.68|0.46|
71745304|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-68 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2785). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.71|0.49|
71834654|NCT02538341|143173763|OTHER|||||||0.31||||||p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.|a generalized linear model|p values, from a generalized linear model on the rank order of the week 6 - baseline change using normal distribution and reciprocal link.||Study protocol defined measure for immunogenicity samples. Participants must have at least 1 post vaccine immunogenicity measure to determine the GMFR (a priori analysis)||||0.31
71834655|NCT05028582|143173861|SUPERIORITY||Odds Ratio, log|5.19|||<|0.0001|TWO_SIDED|97.5|2.9|9.31|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|S-IGA Success at Week 8||9.31|2.90|<0.0001
71834656|NCT05028582|143173862|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|97.5|1.75|5.73|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|B-IGA Success at Week 8||5.73|1.75|<0.0001
71665672|NCT02933255|142845661|OTHER||||||>|0.999||||||The reported p-value is representative of changes in CD4+ naive T cells at week 10 post treatment compared to baseline in the neoadjuvant cohort.|Wilcoxon Signed Rank Test|||||||>0.999
71665673|NCT04803305|142845672|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.38|1.18|||||Week 4|||1.18|-2.38|
71665674|NCT04803305|142845673|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|-0.75|3.15|||||Week 1|||3.15|-0.75|
71665675|NCT04803305|142845673|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-0.28|2.49|||||Week 2|||2.49|-0.28|
71665676|NCT04803305|142845673|SUPERIORITY||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-0.93|2.99|||||Week 3|||2.99|-0.93|
71665677|NCT04803305|142845673|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-2.02|2.02|||||Week 5|||2.02|-2.02|
71665678|NCT04803305|142845673|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.11|1.51|||||Week 6|||1.51|-3.11|
71665679|NCT04803305|142845674|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.98|||TWO_SIDED|90.0|-4.18|3.53|||||Week 1|||3.53|-4.18|
71778800|NCT03572972|143057476|SUPERIORITY||Hazard Ratio (HR)|0.771|||||TWO_SIDED|95.0|0.578|1.027||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.027|0.578|
71778801|NCT03572972|143057477|SUPERIORITY||Hazard Ratio (HR)|0.581|||||TWO_SIDED|95.0|0.481|0.701||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.701|0.481|
71778802|NCT03572972|143057477|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.534|0.766||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.766|0.534|
71778803|NCT03572972|143057477|SUPERIORITY||Hazard Ratio (HR)|0.838|||||TWO_SIDED|95.0|0.622|1.13|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.130|0.622|
71834657|NCT05028582|143173863|OTHER|SI-NRS Success at Week 4|Odds Ratio (OR)|4.67||||0.0005|TWO_SIDED|97.5|1.6|13.62|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||13.62|1.60|0.0005
71665680|NCT04803305|142845674|SUPERIORITY||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-5.49|1.16|||||Week 2|||1.16|-5.49|
71665681|NCT04803305|142845674|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-0.62|2.06|||||Week 3|||2.06|-0.62|
71665682|NCT04803305|142845674|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.29|2.2|||||Week 4|||2.20|-1.29|
71665683|NCT04803305|142845674|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.21|2.57|||||Week 5|||2.57|-1.21|
71665684|NCT04803305|142845674|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|0.34|3.39|||||Week 6|||3.39|0.34|
71665685|NCT00754546|142845677|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||"ANOVA was used to examine the interaction between mode of exercise and treatment effect.~Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05."||||< 0.05
71665686|NCT00754546|142845677|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||Comparing arformoterol with placebo with treadmill exercise||||0.024
71665687|NCT00754546|142845677|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||Arformoterol versus normal saline with cycle exercise||||0.038
71665688|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.989|||||TWO_SIDED|95.0|0.223|4.393|||||Hazard ratio comparing PFS of participants with a high expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4EBP1 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4EBP1 Cytoplasm with PFS.||4.393|0.223|
71665689|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.071|||||TWO_SIDED|95.0|0.316|3.628|||||Hazard ratio comparing PFS of participants with a high expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of EIF4E Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker EIF4E Cytoplasm with PFS.||3.628|0.316|
71665690|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.658|||||TWO_SIDED|95.0|0.454|6.053|||||Hazard ratio comparing PFS of participants with a high expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of HDAC2 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker HDAC2 Nucleus with PFS.||6.053|0.454|
71665691|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|4.082|||||TWO_SIDED|95.0|0.455|36.628|||||Hazard ratio comparing PFS of participants with a high expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PCREB Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PCREB Nucleus with PFS.||36.628|0.455|
71778804|NCT03572972|143057478|SUPERIORITY||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.732|1.061||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.061|0.732|
71778805|NCT03572972|143057478|SUPERIORITY||Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.678|0.947||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||0.947|0.678|
71778806|NCT03572972|143057478|SUPERIORITY||Hazard Ratio (HR)|0.882|||||TWO_SIDED|95.0|0.754|1.032||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.||1.032|0.754|
71778807|NCT01757535|143057479|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0009|TWO_SIDED|95.0|0.55|0.86||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.||The confidence interval (CI) for the difference was derived using Kosorok's method.|0.86|0.55|0.0009
71778808|NCT01757535|143057480|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.52|0.8||The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.|Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.|||0.80|0.52|< 0.0001
71778809|NCT01757535|143057486|SUPERIORITY||Hazard Ratio (HR)|0.9345||||0.7522|TWO_SIDED|95.0|0.6136|1.4231||Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no|Regression, Cox|||||1.4231|0.6136|0.7522
71778810|NCT05147428|143057510|SUPERIORITY||Cox Proportional Hazard|0.99||||0.76|TWO_SIDED|95.0|0.94|1.04|||Log Rank|||For the primary analysis, we combined all three targeted medication classes (antipsychotics, sedative/hypnotics, or strong anticholinergics). We calculated Kaplan-Meier curves and performed log-rank testing, and estimated hazard ratios using Cox proportional hazards modeling, censoring at death or disenrollment from the health plan, or at the end of the 6-month study observation period, whichever came first. The index date for the survival analysis was the end of the 3-month blackout period.||1.04|0.94|0.76
71778811|NCT05147428|143057511|SUPERIORITY|||||||0.33|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.33
71778812|NCT05147428|143057512|SUPERIORITY|||||||0.55|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.55
71778813|NCT05147428|143057513|SUPERIORITY|||||||0.47|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.47
71778814|NCT05147428|143057514|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
71665692|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636|||||TWO_SIDED|95.0|0.18|2.253|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Cytoplasm with PFS.||2.253|0.180|
71778815|NCT05147428|143057516|SUPERIORITY|||||||0.19|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.19
71778816|NCT05147428|143057517|SUPERIORITY|||||||0.46|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.46
71778817|NCT05147428|143057518|SUPERIORITY|||||||0.79|||||||Chi-squared|||Secondary outcomes were analyzed only for those patients who were not censored due to health plan disenrollment or death over the 6-month study observation period (n = 10 424). For analyses of secondary outcomes, we compared the 3 arms using chi-square testing for dichotomous outcomes.||||0.79
71778818|NCT00418015|143057534|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Log Rank|||Log rank test||||0.54
71665693|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.362|||||TWO_SIDED|95.0|0.083|1.576|||||Hazard ratio comparing PFS of participants with a high expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIF3746 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIF3746 Nucleus with PFS.||1.576|0.083|
71778819|NCT00418015|143057535|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Log Rank|||||||0.15
71778820|NCT00418015|143057536|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared, Corrected|||||||0.06
71778821|NCT00418015|143057537|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared, Corrected|||||||0.02
71778822|NCT00418015|143057538|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
71778823|NCT00418015|143057538|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.84
71778824|NCT00316719|143057542|NON_INFERIORITY_OR_EQUIVALENCE|This is a Non-inferiority Analysis with the margin of -1.0.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.309|<|0.001||95.0|-0.94|0.28|||ANCOVA|||||0.28|-0.94|<0.001
71778825|NCT02903355|143057555|SUPERIORITY|||||||0.4385|||||||Fisher Exact|||||||.4385
71778826|NCT02903355|143057556|SUPERIORITY|||||||0.5562|||||||Fisher Exact|||||||.5562
71778827|NCT02903355|143057557|SUPERIORITY|||||||0.5441|||||||Fisher Exact|||||||.5441
71778828|NCT02903355|143057558|SUPERIORITY|||||||0.3666|||||||Fisher Exact|||||||.3666
71778829|NCT02903355|143057559|SUPERIORITY|||||||0.4446|||||||Fisher Exact|||||||.4446
71778830|NCT02903355|143057560|SUPERIORITY|||||||0.5431|||||||Fisher Exact|||||||.5431
71778831|NCT02903355|143057561|SUPERIORITY|||||||0.7409|||||||Fisher Exact|||||||.7409
71778832|NCT02903355|143057562|SUPERIORITY|||||||0.1597|||||||Fisher Exact|||||||.1597
71778833|NCT02903355|143057563|SUPERIORITY|||||||0.2784|||||||t-test, 1 sided|||||||.2784
71778834|NCT02903355|143057564|SUPERIORITY|||||||0.2303|||||||Fisher Exact|||||||.2303
71778835|NCT02468674|143057565|OTHER|||||||0.759|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.759
71778836|NCT02468674|143057565|OTHER|||||||0.5|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.500
71778837|NCT02468674|143057565|OTHER|||||||0.144|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.144
71891000|NCT03068715|143304056|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
71778838|NCT02468674|143057565|OTHER|||||||0.648|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49||||0.648
71778839|NCT02468674|143057565|OTHER|||||||0.929|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.929
71778840|NCT02468674|143057565|OTHER|||||||0.53|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49||||0.530
71778841|NCT02468674|143057566|OTHER|||||||0.839|||||||ANCOVA|Difference in the least square means (SE)||Population II: SPPB total score at Week 49||||0.839
71778842|NCT02468674|143057567|OTHER|||||||0.669|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.669
71778843|NCT02468674|143057567|OTHER|||||||0.773|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.773
71778844|NCT02468674|143057567|OTHER|||||||0.29|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.290
71778845|NCT02468674|143057567|OTHER|||||||0.766|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.766
71778846|NCT02468674|143057567|OTHER|||||||0.885|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.885
71778847|NCT02468674|143057567|OTHER|||||||0.84|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49||||0.840
71778848|NCT02468674|143057568|OTHER|||||||0.367|||||||ANCOVA|Difference in the least square means (SE)||Population II: 6MWT at Week 49||||0.367
71778849|NCT02468674|143057569|OTHER|||||||0.875|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.875
71778850|NCT02468674|143057569|OTHER|||||||0.909|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.909
71778851|NCT02468674|143057569|OTHER|||||||0.168|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.168
71778852|NCT02468674|143057569|OTHER|||||||0.632|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.632
71778853|NCT02468674|143057569|OTHER|||||||0.31|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.310
71778854|NCT02468674|143057569|OTHER|||||||0.321|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49||||0.321
71778855|NCT02468674|143057570|OTHER|||||||0.395|||||||ANCOVA|Difference in the least square means (SE)||Population II: Gait speed at Week 49||||0.395
71778856|NCT02468674|143057571|OTHER|||||||0.12|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.120
71778857|NCT02468674|143057571|OTHER|||||||0.297|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.297
71778858|NCT02468674|143057571|OTHER|||||||0.074|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.074
71778859|NCT02468674|143057571|OTHER|||||||0.022|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.022
71778860|NCT02468674|143057571|OTHER|||||||0.106|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.106
71778861|NCT02468674|143057571|OTHER|||||||0.211|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49||||0.211
71778862|NCT02468674|143057572|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: ASMI at Week 49||||1.000
71778863|NCT02468674|143057573|OTHER|||||||0.084|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.084
71778864|NCT02468674|143057573|OTHER|||||||0.283|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.283
71778865|NCT02468674|143057573|OTHER|||||||0.323|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.323
71891001|NCT03068715|143304059|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.001|||||||Mixed Models Analysis|||HDRS-17 scores were assessed with generalized linear mixed models (GLMM) that used Satterthwaite approximation of degrees of freedom and robust estimation of coefficients to handle violations of model assumptions. Fixed effects of time, treatment group (sham vs. active) and their interaction were assessed.||||=0.001
71665694|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.522|||||TWO_SIDED|95.0|0.473|4.901|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS209 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS209 Cytoplasm with PFS.||4.901|0.473|
71665695|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.908|||||TWO_SIDED|95.0|0.223|3.699|||||Hazard ratio comparing PFS of participants with a high expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFS65 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFS65 Nucleus with PFS.||3.699|0.223|
71778866|NCT02468674|143057573|OTHER|||||||0.018|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.018
71778867|NCT02468674|143057573|OTHER|||||||0.179|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.179
71778868|NCT02468674|143057573|OTHER|||||||0.227|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49||||0.227
71778869|NCT02468674|143057574|OTHER|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: LBM at Week 49||||1.000
71778870|NCT00094172|143057616|SUPERIORITY_OR_OTHER|||||||0.929|||||||Log Rank|||This is the primary analysis of the primary endpoint||||0.929
71778871|NCT00094172|143057616|SUPERIORITY_OR_OTHER|||||||0.823|||||||Fisher Exact|||This is the secondary analysis of the primary endpoint||||0.823
71778872|NCT00094172|143057617|SUPERIORITY_OR_OTHER|||||||0.208|||||||Log Rank|||||||.208
71778873|NCT00094172|143057618|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Log Rank|||||||0.526
71778874|NCT03019575|143057626|OTHER|Linear Mixed Model|Geometric Mean Ratio|9.43|||||TWO_SIDED|95.0|7.44|11.97||||||||11.97|7.44|
71778875|NCT00533897|143057643|SUPERIORITY_OR_OTHER||estimate of difference|9.59||||0.119|TWO_SIDED|95.0|0.83|18.34||There was no adjustment made for multiple comparisons.|Chi-squared, Corrected|||A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided.||18.34|0.83|0.119
71778876|NCT00533897|143057644|SUPERIORITY_OR_OTHER||Estimate of Difference|4.88|||||TWO_SIDED|95.0|-4.5|14.25||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||14.25|-4.50|
71778877|NCT00533897|143057648|SUPERIORITY_OR_OTHER||Estimate of Difference|0.11|||||TWO_SIDED|95.0|-8.21|8.43||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.||8.43|-8.21|
71778878|NCT02478632|143057718|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.014|TWO_SIDED|95.0|0.27|2.31|||ANCOVA|||||2.31|0.27|0.014
71778879|NCT02478632|143057719|SUPERIORITY||Mean Difference (Final Values)|1.32||||0.039|TWO_SIDED|95.0|0.07|2.57|||ANCOVA|||||2.57|0.07|0.039
71778880|NCT02478632|143057722|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.016|TWO_SIDED|95.0|0.02|0.16||p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores|||0.16|0.02|0.016
71778881|NCT02478632|143057722|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.026|TWO_SIDED|95.0|0.01|0.15||p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.|||0.15|0.01|0.026
71778882|NCT02478632|143057722|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.049|TWO_SIDED|95.0|0.0|0.23||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.|||0.23|0.00|0.049
71778883|NCT02478632|143057722|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.013|TWO_SIDED|95.0|0.03|0.27||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.|||0.27|0.03|0.013
71778884|NCT02478632|143057725|OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|95.0|-3.51|4.81|||||The analysis refers to INSTI and total hip.|||4.81|-3.51|
71778885|NCT02478632|143057725|OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|0.39|2.81|||||The analysis refers to NNRTI and total hip.|||2.81|0.39|
71778886|NCT02478632|143057725|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-1.39|3.38|||||this analysis refers to PI and total hip|||3.38|-1.39|
71778887|NCT02478632|143057725|OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|0.67|7.03|||||this analysis refers to INSTI and lumbar spine.|||7.03|0.67|
71778888|NCT02478632|143057725|OTHER||Mean Difference (Final Values)|1.25|||||TWO_SIDED|95.0|-0.26|2.76|||||this analysis refers to NNRTI and lumbar spine|||2.76|-0.26|
71778889|NCT02478632|143057725|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-3.0|3.77|||||this analysis refers to PI and lumbar spine|||3.77|-3.00|
71778890|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.26|0.3|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.|||0.30|-0.26|
71778891|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|0.03|0.19|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.|||0.19|0.03|
71778892|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-0.09|0.24|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.|||0.24|-0.09|
71778893|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.25|0.37|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.|||0.37|-0.25|
71778894|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|0.02|0.18|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.|||0.18|0.02|
71778895|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.14|0.21|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.|||0.21|-0.14|
71778896|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|0.01|0.71|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.|||0.71|0.01|
71778897|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.03|0.25|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.|||0.25|-0.03|
71778898|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.3|0.33|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.|||0.33|-0.30|
71778899|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|0.03|0.74|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.|||0.74|0.03|
71778900|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.02|0.26|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.|||0.26|-0.02|
71665696|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.843|||||TWO_SIDED|95.0|0.432|7.867|||||Hazard ratio comparing PFS of participants with a high expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PEIFT70 Nucleus \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PEIFT70 Nucleus with PFS.||7.867|0.432|
71778901|NCT02478632|143057726|OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.|||0.34|-0.26|
71778902|NCT04622306|143057731|NON_INFERIORITY|The non-inferiority margin for the difference in total clinical failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified in ISO 23409:2011 as 2.5%.|Upper 97.5% CL for difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Expected test condom total clinical failure rate - expected control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
71778903|NCT04622306|143057731|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CLof difference|2.5||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set.|GEE|||Null Hypothesis: Test condom total clinical failure rate - control natural rubber latex male condom total clinical failure rate ≥ δ, where δ = 2.5%; Power calculations were conducted according to ISO 29943-1:2017. Target sample sizes were chosen to provide a power of at least 90%.||2.5||0.025
71778904|NCT04622306|143057731|NON_INFERIORITY|The non-inferiority margin for the difference in total failure rates (clinical breakage plus clinical slippage) between the test and control condom is specified on ISO 23409:2011 as 2.5%|Upper 97.5% CL for difference|2.37||||0.025|ONE_SIDED|97.5||2.5||The p-value was adjusted to 0.025 since two comparisons are being made on the data set|GEE|||The non-inferiority analysis was repeated after removing couples where the male partner had a penis length greater than 170 mm. The polyurethane condom B has a specified nominal length of 170 mm and is not recommended for men with penises longer than the length of the condom.||2.5||0.025
71778905|NCT01601132|143057768|SUPERIORITY_OR_OTHER|||||||0.5663||||||Significant difference defined a priori as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.5663
71778906|NCT01601132|143057769|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.86|||||TWO_SIDED|90.0|101.77|110.12|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Cmax, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Cmax to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, (AUC0-∞), and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||110.12|101.77|
71778907|NCT01601132|143057770|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|105.63|||||TWO_SIDED|90.0|101.81|109.59|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-t)\], expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-t) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||109.59|101.81|
71834658|NCT05028582|143173864|SUPERIORITY||Odds Ratio (OR)|4.39|||<|0.0001|TWO_SIDED|97.5|2.01|9.55|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|SI-NRS Success at Week 4||9.55|2.01|<0.0001
71665697|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926|||||TWO_SIDED|95.0|0.276|3.109|||||Hazard ratio comparing PFS of participants with a high expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of P GSK3B Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker P GSK3B Cytoplasm with PFS.||3.109|0.276|
71665698|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.985|||||TWO_SIDED|95.0|0.32|3.033|||||Hazard ratio comparing PFS of participants with a high expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PKCb2 Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PKCb2 Cytoplasm with PFS.||3.033|0.320|
71665699|NCT00451178|142845709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.817|||||TWO_SIDED|95.0|0.242|2.758|||||Hazard ratio comparing PFS of participants with a high expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\] versus participants with a low expression of PTEN Cytoplasm \[(R-CHOP and Enzastaurin) and (R-CHOP) combined\].|The correlation of biomarker PTEN Cytoplasm with PFS.||2.758|0.242|
71665700|NCT03922529|142845775|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.543|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5430
71778908|NCT01601132|143057771|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|106.43|||||TWO_SIDED|90.0|101.1|112.04|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-∞) , expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-∞) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||112.04|101.10|
71778909|NCT01601132|143057772|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|93.96|||||TWO_SIDED|90.0|89.25|98.92|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed CL/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed CL/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||98.92|89.25|
71778910|NCT01601132|143057773|SUPERIORITY_OR_OTHER||Ratio (%) (Test/Reference)|98.59|||||TWO_SIDED|90.0|90.97|106.85|||ANOVA||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Vd/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Vd/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.||106.85|90.97|
71778911|NCT03881670|143057807|OTHER|Friedman test||||||0.0023|||||||Friedman Test|||Change in ratings over time||||0.0023
71778912|NCT03881670|143057807|OTHER|Friedman test||||||0.4679|||||||Friedman Test|||change in ratings over time||||0.4679
71778913|NCT00914485|143057809|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 1 sided|||Increase in mean, post-intervention versus baseline, across 18 providers and 369 patients.||||.03
71778914|NCT04889222|143057811|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0.00097||||||The a priori threshold for p-value was 0.05.|Two One Sided Tests (TOST)|||||||0.00097
71778915|NCT04889222|143057812|EQUIVALENCE|A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.||||||0||||||The a priori threshold for p-value was 0.05.|Two One-Sided Tests (TOST)|||||||0.00000
71778916|NCT04873700|143057823|SUPERIORITY||||||=|0.0701|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.0701
71778917|NCT04873700|143057823|SUPERIORITY||||||=|0.1383|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.1383
71778918|NCT04873700|143057823|SUPERIORITY||||||=|0.0478|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Perianal disease||||=0.0478
71778919|NCT04873700|143057823|SUPERIORITY||||||=|0.1454|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Ileal disease||||=0.1454
71778920|NCT04873700|143057823|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=1.0000
71778921|NCT04873700|143057823|SUPERIORITY||||||=|0.4992|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=0.4992
71778922|NCT04873700|143057823|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Episcleritis||||=1.0000
71778923|NCT04873700|143057823|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Uveitis||||=1.0000
71778924|NCT04873700|143057823|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
71778925|NCT04873700|143057823|SUPERIORITY||||||=|0.2022|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.2022
71665701|NCT03922529|142845776|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7625|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7625
71665702|NCT03922529|142845777|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.8842|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8842
71665703|NCT03922529|142845778|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.4086|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4086
71665704|NCT03922529|142845779|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.3841|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.3841
71665705|NCT03922529|142845780|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.2||0.1393|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|||The adjusted difference from a model may not necessarily match the raw difference between groups.|||0.1393
71665706|NCT03922529|142845781|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|12.3||0.9257|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9257
71665707|NCT03922529|142845782|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|11.8||0.6588|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6588
71665708|NCT03922529|142845783|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|13.0||0.992|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9920
71665709|NCT03922529|142845784|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9504|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9504
71665710|NCT03922529|142845785|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.6228|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6228
71665711|NCT03922529|142845786|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7966|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7966
71665712|NCT03922529|142845787|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5071|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5071
71665713|NCT03922529|142845788|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5553|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.5553
71665714|NCT03922529|142845789|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1194|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1194
71665715|NCT03922529|142845790|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9012|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.9012
71665716|NCT03922529|142845791|SUPERIORITY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4279|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4279
71665717|NCT03922529|142845792|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.8||0.1932|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.1932
71665718|NCT03922529|142845793|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.2723|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2723
71778926|NCT04873700|143057823|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
71665719|NCT03922529|142845794|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8951|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8951
71834659|NCT05028582|143173865|OTHER|SI-NRS Success at Week 8|Odds Ratio (OR)|5.41|||<|0.0001|TWO_SIDED|97.5|2.49|11.78|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B-IGA with multiple imputation to handle missing data|||11.78|2.49|<0.0001
71834660|NCT05028582|143173866|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.35||||0.0164|TWO_SIDED|97.5|-0.68|-0.02|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.02|-0.68|0.0164
71834661|NCT05028582|143173867|SUPERIORITY|SI-NRS Change from Baseline Day 1|LS Mean Difference|-0.76|||<|0.0001|TWO_SIDED|97.5|-1.12|-0.39|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.39|-1.12|<0.0001
71834662|NCT05028582|143173868|SUPERIORITY|Change from Baseline in Weekly SI-NRS at Week 1|LS Mean Difference|-0.55||||0.0002|TWO_SIDED|97.5|-0.87|-0.22|||ANCOVA|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|ANCOVA terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline SI-NRS score|||-0.22|-0.87|0.0002
71891002|NCT03068715|143304060|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.308|||||||t-test, 2 sided|Paired-t test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.308
71891003|NCT03068715|143304060|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.778|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.778
71778927|NCT04873700|143057823|SUPERIORITY||||||=|0|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.0000
71778928|NCT04873700|143057824|SUPERIORITY||||||=|0.2896|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Location of disease||||=0.2896
71778929|NCT04873700|143057824|SUPERIORITY||||||=|0.0006|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Disease behavior||||=0.0006
71778930|NCT04873700|143057824|SUPERIORITY||||||=|0.089|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Peripheral arthritis||||=0.0890
71778931|NCT04873700|143057824|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Pyoderma gangrenosum||||=1.0000
71778932|NCT04873700|143057824|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Aphthous ulcers||||=1.0000
71778933|NCT04873700|143057824|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Primary sclerosing cholangitis||||=1.0000
71778934|NCT04873700|143057824|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Osteoporosis||||=1.0000
71778935|NCT04873700|143057824|SUPERIORITY||||||=|0.0752|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Anemia||||=0.0752
71778936|NCT04873700|143057824|SUPERIORITY||||||=|1|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Hematological alteration||||=1.0000
71778937|NCT04873700|143057824|SUPERIORITY||||||=|0.1032|||||||Chi-squared|p-value was obtained from Chi-square/Fisher's exact test.||Extraintestinal manifestations: Other||||=0.1032
71778938|NCT00702689|143057847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|||||||Paired t-test|||||||.011
71778939|NCT00702689|143057849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||t-test, 2 sided|||||||.47
71778940|NCT00702689|143057850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||t-test, 2 sided|||||||.29
71778941|NCT01961362|143057880|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_DEVIATION|0.87||0.6|TWO_SIDED|||||P\<0.05 considered to represent statistical significance.|t-test, 2 sided|||||||0.6
71778942|NCT01961362|143057880|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71778943|NCT01961362|143057881|SUPERIORITY||Median Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71778944|NCT01761175|143057890|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
71778945|NCT01761175|143057891|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
71778946|NCT01761175|143057892|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
71778947|NCT01761175|143057893|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Log Rank|||||||<0.01
71778948|NCT01761175|143057894|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
71778949|NCT01761175|143057895|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71778950|NCT01761175|143057896|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71778951|NCT00467857|143057907|SUPERIORITY_OR_OTHER|||||||0.655||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.655
71778952|NCT00467857|143057908|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Wilcoxon-Rank Sum Test|||||||0.276
71778953|NCT00467857|143057909|SUPERIORITY_OR_OTHER|||||||0.375||95.0|||||Wilcoxon-Rank Sum Test|||||||0.375
71778954|NCT00467857|143057910|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Wilcoxon-Rank Sum Test|||||||0.039
71778955|NCT00467857|143057911|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Wilcoxon-Rank Sum Test|||||||0.057
71778956|NCT00467857|143057912|SUPERIORITY_OR_OTHER|||||||0.646||95.0|||||Wilcoxon-Rank Sum Test|||||||0.646
71778957|NCT00467857|143057913|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon-Rank Sum Test|||||||0.788
71778958|NCT00467857|143057914|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon-Rank Sum Test|||||||0.960
71778959|NCT00467857|143057915|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.||||0.359
71778960|NCT00467857|143057916|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon-Rank Sum Test|||||||0.730
71778961|NCT00467857|143057917|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Wilcoxon-Rank Sum Test|||||||0.348
71778962|NCT00467857|143057918|SUPERIORITY_OR_OTHER|||||||0.512||95.0|||||Wilcoxon-Rank Sum Test|||||||0.512
71778963|NCT00467857|143057919|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Chi-squared|||||||0.285
71778964|NCT00467857|143057920|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Fisher Exact|||||||0.024
71778965|NCT03576495|143057930|SUPERIORITY|"We conducted a superiority statistical test to assess if residents' knowledge improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident knowledge, resident knowledge was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."|Mean Difference (Final Values)|2.6||||0.2422|TWO_SIDED|||||This p-value compares the average scores (in percent) of the residents' knowledge assessment at time period 2 between the Early Intervention and Delayed Intervention groups.|t-test, 2 sided|||||||0.2422
71778966|NCT03576495|143057931|SUPERIORITY||Difference between percentage|0.0||||1|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' preparation for caring for culturally diverse patients improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident preparedness assessed by the Cross-Cultural Care Survey, resident preparedness was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||1.000
71834663|NCT05028582|143173869|OTHER|WI-NRS Success at Week 8|Odds Ratio (OR)|4.14|||<|0.0001|TWO_SIDED|97.5|2.01|8.52|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||8.52|2.01|<0.0001
71665720|NCT03922529|142845795|SUPERIORITY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.2||0.2574|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2574
71665721|NCT03922529|142845796|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8307|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8307
71834664|NCT05028582|143173870|SUPERIORITY|PASI-75 at Week 8|Odds Ratio (OR)|5.42|||<|0.0001|TWO_SIDED|97.5|2.73|10.75|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.75|2.73|<0.0001
71665722|NCT03922529|142845797|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.614|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.6140
71665723|NCT03922529|142845798|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.0||0.7327|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7327
71778967|NCT03576495|143057932|SUPERIORITY||Percent difference|0.9||||0.6295|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' self-assessed skills improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident skills, resident skills were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.6295
71778968|NCT03576495|143057933|SUPERIORITY||Difference between percentage|2.5||||0.0199|TWO_SIDED||||||Fisher Exact|||"We conducted a superiority statistical test to assess if residents' beliefs improved after exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum on resident beliefs, beliefs were compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups."||||0.0199
71778969|NCT03576495|143057934|SUPERIORITY||difference in the percentage|2.2||||0.2665|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Limited English Proficiency and Informed Consent OSCE."||||0.2665
71778970|NCT03576495|143057934|SUPERIORITY||difference in the percentage|6.2||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if residents' OSCE performance improved after exposure to the PACTS curriculum. OSCE performance was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in the percentage of residents designated mostly and a great deal on Trust and Pain."||||0.0001
71778971|NCT03576495|143057935|SUPERIORITY||absolute difference between percentage|3.19||||0.5079|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to trust at time period 2."||||0.5079
71665724|NCT03922529|142845799|SUPERIORITY|||||||0.7651|||||||Wilcoxon rank sum|||||||0.7651
71834665|NCT05028582|143173871|SUPERIORITY|PSD Aggregate Score Change at Week 8|LS Mean Difference|-5.12|||<|0.0001|TWO_SIDED|97.5|-6.64|-3.6|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA and baseline PSD aggregate score \& multiple imputation of missing data|||-3.60|-6.64|<0.0001
71665725|NCT03922529|142845800|SUPERIORITY||Incident Rate Ratio|1.15||||0.3974|TWO_SIDED|95.0|0.83|1.59|||Negative binomial regression models|||||1.59|0.83|0.3974
71665726|NCT03922529|142845801|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.5||0.2727|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.2727
71665727|NCT03922529|142845802|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.5||0.4269|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4269
71665728|NCT03922529|142845803|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.6||0.4354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.4354
71665729|NCT03922529|142845804|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8695|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8695
71778972|NCT03576495|143057935|SUPERIORITY||absolute difference between percentage|1.92||||0.1571|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the curriculum, patient satisfaction was compared at Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to limited English proficiency at period 2."||||0.1571
71778973|NCT03576495|143057935|SUPERIORITY||absolute difference between percentage|4.76||||0.0001|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to consent at time period 2."||||0.0001
71778974|NCT03576495|143057935|SUPERIORITY||absolute difference between percentage|0.19||||0.2956|TWO_SIDED||||||Chi-squared|||"We conducted a superiority statistical test to assess if patient satisfaction improved after resident exposure to the PACTS curriculum. For purposes of measuring an effect of the PACTS curriculum, patient satisfaction was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups. We compared the difference in proportion of patients who reported agree and strongly agree for satisfaction as it relates to pain at time period 2."||||0.2956
71778975|NCT03576495|143057936|SUPERIORITY||Cox Proportional Hazard|5.31||||0.0028|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||We used Cox Proportional Hazard to assess time to discharge, with 5.31 days as the estimated value for the difference between the two groups.|"We conducted a superiority statistical test to assess if patients length of stay improved after resident exposure to the PACTS curriculum. Patient length of stay was compared at time Period 2 between the Early Intervention (intervention) and Delayed Intervention (control) groups to measure an effect of the PACTS intervention."||||0.0028
71778976|NCT00579098|143057944|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.75
71778977|NCT00579098|143057945|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||A p-value of \< 0.05 was considered statistically significant.|Log Rank|||||||0.37
71778978|NCT00579098|143057946|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.11
71778979|NCT00579098|143057947|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||Comparison between treatment groups. A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||||||0.53
71778980|NCT00579098|143057948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in total cholesterol was compared between treatment groups.||||<0.001
71778981|NCT00579098|143057948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in LDL cholesterol was compared between treatment groups.||||<0.001
71778982|NCT00579098|143057948|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||A p-value of \< 0.05 was considered statistically significant.|t-test, 2 sided|||The change in HDL cholesterol was compared between treatment groups.||||0.92
71778983|NCT03329508|143057971|SUPERIORITY||Differences of Least Square Means|-2.66|STANDARD_ERROR_OF_MEAN|0.85||0.0018|TWO_SIDED|95.0|-4.33|-1.0|||MMRM|||||-1.0|-4.33|0.0018
71778984|NCT03329508|143057971|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.85||0.0001|TWO_SIDED|95.0|-4.96|-1.63|||MMRM|||||-1.63|-4.96|0.0001
71778985|NCT03329508|143057972|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.0001
71778986|NCT03329508|143057972|SUPERIORITY||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|0.43|<|0.05|TWO_SIDED|95.0|-3.5|-1.81|||MMRM|||||-1.81|-3.50|<0.05
71778987|NCT03329508|143057973|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.67||0.0231|TWO_SIDED|95.0|-2.84|-0.21|||MMRM|||||-0.21|-2.84|0.0231
71778988|NCT03329508|143057973|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.67||0.0092|TWO_SIDED|95.0|-3.06|-0.43|||MMRM|||||-0.43|-3.06|0.0092
71778989|NCT03329508|143057974|SUPERIORITY||Mean Difference (Net)|-1.17|STANDARD_ERROR_OF_MEAN|0.31||0.0001|TWO_SIDED|95.0|-1.77|-0.57|||MMRM|||||-0.57|-1.77|0.0001
71778990|NCT03329508|143057974|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.13|-0.92|||MMRM|||||-0.92|-2.13|<0.0001
71778991|NCT03329508|143057975|SUPERIORITY||Mean Difference (Net)|-2.18|STANDARD_ERROR_OF_MEAN|1.54||0.1589|TWO_SIDED|95.0|-5.21|0.85|||MMRM|||||0.85|-5.21|0.1589
71778992|NCT00569270|143057976|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||a priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FEV1 of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.027
71778993|NCT00569270|143057977|SUPERIORITY_OR_OTHER||Spearman rho|0.19||||0.96||95.0||||A priori threshold for statistical significance: p=0.05|Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measure includes change in FEV1 post tiotropium||||0.96
71778994|NCT00569270|143057978|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak FRC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.318
71778995|NCT00569270|143057979|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was p \< 0.05|Mixed Models Analysis|||Mean difference of Peak FVC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.078
71778996|NCT00569270|143057980|SUPERIORITY_OR_OTHER||Spearman rho|-0.26||||0.4||95.0|||||Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (19 patients); measures include change in IC at trough tiotropium.||||0.4
71778997|NCT00569270|143057981|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Peak IC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.067
71778998|NCT00569270|143057982|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||A priori threshold for statistical significance: p\<0.05|Regression, Logistic|||Mean difference of Peak FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.615
71778999|NCT00569270|143057983|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Statistical significance was p\<0.05|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.325
71779000|NCT00569270|143057984|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.345
71779001|NCT00569270|143057985|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC(L) in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.068
71779002|NCT00569270|143057986|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of trough FVC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.589
71779003|NCT00569270|143057987|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough IC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.922
71779004|NCT00569270|143057988|SUPERIORITY_OR_OTHER|||||||-0.02||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.02
71779005|NCT00569270|143057989|SUPERIORITY_OR_OTHER|||||||-0.13||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Mean difference of Trough TLC (L) of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||-0.13
71779006|NCT00569270|143057990|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||A priori threshold for statistical significance: p\<0.05|Mixed Models Analysis|||Change in IC before and after dynamic hyperinflation. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||0.0001
71779007|NCT00569270|143057991|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Total lung capacity was similar in all groups and was not significant|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L||||>0.05
71779008|NCT00569270|143057992|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||A priori threshold for statistical significance: p= 0.05|Spearman rho|Spearman rho = -0.26||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema||||0.36
71665730|NCT03922529|142845805|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.4||0.7075|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.7075
71745305|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.5|||||TWO_SIDED|95.0|0.41|0.61||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.61|0.41|
71745306|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.97|||||TWO_SIDED|95.0|0.84|1.12||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-31/33/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2824). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||1.12|0.84|
71745307|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|0.75|||||TWO_SIDED|95.0|0.63|0.88||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||0.88|0.63|
71745308|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|2.11|||||TWO_SIDED|95.0|1.91|2.33||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HPV-16/18/33/31/45 incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||2.33|1.91|
71745309|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.13|||||TWO_SIDED|95.0|4.79|5.49||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.49|4.79|
71745310|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.72|||||TWO_SIDED|95.0|5.36|6.1||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HRW-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.10|5.36|
71745311|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|5.29|||||TWO_SIDED|95.0|4.94|5.65||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received HPV vaccine in that study (N=2823). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||5.65|4.94|
71745312|NCT03629886|143001618|OTHER|The IR (n/T) of incident cervical infection with any oncogenic HPV type or combination of oncogenic HPV types (per 100 Person-years rate) was calculated as the number of subjects reporting at least one event (n) in a group (assessed by detecting HPV DNA using PCR), over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100 and 95% Confidence Intervals (CI) were used for calculation.|Incidence rate per 100-Person years|6.29|||||TWO_SIDED|95.0|5.91|6.69||||||Analysis was performed to assess the protective effect of HPV Vaccine in terms of incidence rate of oncogenic HR-HPV incident cervical infection, in subjects who participated in the HPV-039 study and who received placebo in that study (N=2825). Those subjects were or were not enrolled in the current study, were HPV DNA negative subjects at baseline and had cervical samples collected data.||6.69|5.91|
71779009|NCT03407625|143058019|SUPERIORITY||Risk Ratio (RR)|1.0||||0.86|TWO_SIDED|95.0|0.95|1.05|||log binomial regression||||We used generalized estimating equations for the log binomial regression with cluster entered as a random effect.|1.05|0.95|0.86
71779010|NCT04154930|143058043|SUPERIORITY||Treatment difference|69.7|||<|0.001|TWO_SIDED|95.0|52.54|86.89|||Cochran-Mantel-Haenszel|||||86.89|52.54|<0.001
71779011|NCT04154930|143058044|SUPERIORITY||Treatment difference|72.5|||<|0.001|TWO_SIDED|95.0|60.67|84.28|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 6 Months After Baseline||84.28|60.67|<0.001
71779012|NCT04154930|143058044|SUPERIORITY||Treatment difference|66.4|||<|0.001|TWO_SIDED|95.0|54.97|77.92|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 9 Months After Baseline||77.92|54.97|<0.001
71779013|NCT04154930|143058044|SUPERIORITY||Treatment difference|52.4|||<|0.001|TWO_SIDED|95.0|40.57|64.26|||Cochran-Mantel-Haenszel|||Responder Rate Based on the Blinded Evaluator's live assessment of the GIHS at 12 Months After Baseline||64.26|40.57|<0.001
71779014|NCT03855228|143058055|SUPERIORITY|||||||0.36|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.36
71779015|NCT03855228|143058055|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779016|NCT03855228|143058055|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779017|NCT03855228|143058055|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779018|NCT03855228|143058055|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71834666|NCT05028582|143173872|SUPERIORITY|PSD Itching Week 8|Odds Ratio (OR)|4.59|||<|0.0001|TWO_SIDED|97.5|2.1|10.04|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||10.04|2.10|<0.0001
71779019|NCT03855228|143058055|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
71779020|NCT03855228|143058056|SUPERIORITY|||||||0.35|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.35
71779021|NCT03855228|143058056|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779022|NCT03855228|143058056|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779023|NCT03855228|143058056|SUPERIORITY|||||||0.03|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.03
71779024|NCT03855228|143058056|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779025|NCT03855228|143058056|SUPERIORITY|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.02
71779026|NCT03855228|143058057|SUPERIORITY|||||||0.77|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.77
71779027|NCT03855228|143058057|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779028|NCT03855228|143058057|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779029|NCT03855228|143058057|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779030|NCT03855228|143058057|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779031|NCT03855228|143058057|SUPERIORITY|||||||0.45|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.45
71779032|NCT03855228|143058058|SUPERIORITY|||||||0.99|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.99
71779033|NCT03855228|143058058|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779034|NCT03855228|143058058|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779035|NCT03855228|143058058|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779036|NCT03855228|143058058|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779037|NCT03855228|143058058|SUPERIORITY|||||||0.08|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.08
71779038|NCT03855228|143058059|SUPERIORITY|||||||0.85|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.85
71779039|NCT03855228|143058059|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779040|NCT03855228|143058059|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779041|NCT03855228|143058059|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779042|NCT03855228|143058059|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779043|NCT03855228|143058059|SUPERIORITY|||||||0.17|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.17
71779044|NCT03855228|143058060|SUPERIORITY|||||||0.88|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.88
71779045|NCT03855228|143058060|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779046|NCT03855228|143058060|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71745313|NCT00346216|143001643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.|Hazard Ratio (HR)|0.93||||0.0002|TWO_SIDED|95.0|0.76|1.13||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.13|0.76|0.0002
71745314|NCT00346216|143001643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40|Hazard Ratio (HR)|0.9||||0.0001|TWO_SIDED|95.0|0.72|1.14||Non inferiority P value, α=0.025|Regression, Cox|||MITT Population||1.14|0.72|0.0001
71745315|NCT00346216|143001643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.0|0.7|1.04||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population||1.04|0.70|<0.0001
71745316|NCT00346216|143001643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|0.81|||<|0.0001|TWO_SIDED|95.0|0.64|1.02||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.02|0.64|<0.0001
71745317|NCT00346216|143001643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33|Hazard Ratio (HR)|1.08||||0.0182|TWO_SIDED|95.0|0.89|1.31||Non-inferiority P-value, α=0.025|Regression, Cox|||ITT Population||1.31|0.89|0.0182
71745318|NCT00346216|143001643|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|1.12||||0.025|TWO_SIDED|95.0|0.89|1.4||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population||1.40|0.89|0.0250
71745319|NCT00346216|143001644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.6427|TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||ITT Population||1.12|0.83|0.6427
71745320|NCT00346216|143001644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.0597|TWO_SIDED|95.0|0.75|1.01|||Regression, Cox|||ITT Population||1.01|0.75|0.0597
71745321|NCT00346216|143001644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.11||||0.1481|TWO_SIDED|95.0|0.96|1.29|||Regression, Cox|||ITT Population||1.29|0.96|0.1481
71745322|NCT00346216|143001644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.5758|TWO_SIDED|95.0|0.8|1.13|||Regression, Cox|||MITT Population||1.13|0.80|0.5758
71745323|NCT00346216|143001644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0204|TWO_SIDED|95.0|0.69|0.97|||Regression, Cox|||MITT Population||0.97|0.69|0.0204
71745324|NCT00346216|143001644|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.0751|TWO_SIDED|95.0|0.98|1.38|||Regression, Cox|||MITT Population||1.38|0.98|0.0751
71745325|NCT00346216|143001645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8576|TWO_SIDED|95.0|0.67|1.4|||Regression, Cox|||ITT Population||1.40|0.67|0.8576
71745326|NCT00346216|143001645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.1202|TWO_SIDED|95.0|0.53|1.08|||Regression, Cox|||ITT Population||1.08|0.53|0.1202
71745327|NCT00346216|143001645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.27||||0.1734|TWO_SIDED|95.0|0.9|1.81|||Regression, Cox|||ITT Population||1.81|0.90|0.1734
71745328|NCT00346216|143001645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0041|TWO_SIDED|95.0|0.32|0.81|||Regression, Cox|||MITT Population||0.81|0.32|0.0041
71745329|NCT00346216|143001645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.0003|TWO_SIDED|95.0|0.27|0.68|||Regression, Cox|||MITT Population||0.68|0.27|0.0003
71745330|NCT00346216|143001645|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.4243|TWO_SIDED|95.0|0.8|1.69|||Regression, Cox|||MITT Population||1.69|0.80|0.4243
71745331|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|1.01|2.53|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||2.53|1.01|<0.0001
71745332|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.39||0.0373|TWO_SIDED|95.0|0.05|1.56|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.56|0.05|0.0373
71745333|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.39||0.0129|TWO_SIDED|95.0|0.2|1.72|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)||1.72|0.20|0.0129
71745334|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.39||0.183|TWO_SIDED|95.0|-0.25|1.29|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.29|-0.25|0.1830
71745335|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.39||0.7777|TWO_SIDED|95.0|-0.88|0.66|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||0.66|-0.88|0.7777
71745336|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.39||0.1072|TWO_SIDED|95.0|-0.14|1.4|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)||1.40|-0.14|0.1072
71745337|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.12|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.46|-0.12|0.8237
71745338|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.4||0.8237|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||0.70|-0.88|0.8237
71745339|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.4||0.0587|TWO_SIDED|95.0|-0.03|1.55|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)||1.55|-0.03|0.0587
71745340|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.41||0.3129|TWO_SIDED|95.0|-0.39|1.23|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.23|-0.39|0.3129
71745341|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.6526|TWO_SIDED|95.0|-0.63|1.0|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.00|-0.63|0.6526
71745342|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5774|TWO_SIDED|95.0|-0.58|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)||1.05|-0.58|0.5774
71745343|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.42||0.0632|TWO_SIDED|95.0|-0.04|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.62|-0.04|0.0632
71745344|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.43||0.454|TWO_SIDED|95.0|-0.52|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.15|-0.52|0.4540
71745345|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.43||0.2705|TWO_SIDED|95.0|-0.37|1.3|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)||1.30|-0.37|0.2705
71745346|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.44||0.5225|TWO_SIDED|95.0|-0.58|1.14|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.14|-0.58|0.5225
71745347|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.44||0.5996|TWO_SIDED|95.0|-1.1|0.63|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||0.63|-1.10|0.5996
71745348|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.44||0.2461|TWO_SIDED|95.0|-0.35|1.38|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)||1.38|-0.35|0.2461
71745349|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.46||0.8127|TWO_SIDED|95.0|-0.79|1.0|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.00|-0.79|0.8127
71745350|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.46||0.9641|TWO_SIDED|95.0|-0.92|0.87|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||0.87|-0.92|0.9641
71745351|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.46||0.7784|TWO_SIDED|95.0|-0.77|1.03|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)||1.03|-0.77|0.7784
71745352|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.49||0.2105|TWO_SIDED|95.0|-0.34|1.56|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.56|-0.34|0.2105
71745353|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.2909|TWO_SIDED|95.0|-0.44|1.46|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.46|-0.44|0.2909
71745354|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.49||0.8459|TWO_SIDED|95.0|-0.86|1.05|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)||1.05|-0.86|0.8459
71745355|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.51||0.1116|TWO_SIDED|95.0|-0.19|1.8|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.80|-0.19|0.1116
71745356|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.51||0.9751|TWO_SIDED|95.0|-0.98|1.01|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.01|-0.98|0.9751
71745357|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.51||0.1202|TWO_SIDED|95.0|-0.21|1.79|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)||1.79|-0.21|0.1202
71745358|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.52||0.3767|TWO_SIDED|95.0|-0.56|1.48|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||1.48|-0.56|0.3767
71745359|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1123|TWO_SIDED|95.0|-1.85|0.19|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||0.19|-1.85|0.1123
71745360|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.52||0.0137|TWO_SIDED|95.0|0.26|2.31|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)||2.31|0.26|0.0137
71745361|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|1.07|2.47|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||2.47|1.07|<0.0001
71745362|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.36||0.0197|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.54|0.13|0.0197
71745363|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.36||0.0094|TWO_SIDED|95.0|0.23|1.64|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)||1.64|0.23|0.0094
71745364|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.37||0.1247|TWO_SIDED|95.0|-0.16|1.31|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.31|-0.16|0.1247
71745365|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.37||0.8278|TWO_SIDED|95.0|-0.81|0.65|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||0.65|-0.81|0.8278
71745366|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.37||0.0802|TWO_SIDED|95.0|-0.08|1.39|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)||1.39|-0.08|0.0802
71745367|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.39||0.0822|TWO_SIDED|95.0|-0.09|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.46|-0.09|0.0822
71745368|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.39||0.8314|TWO_SIDED|95.0|-0.86|0.69|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||0.69|-0.86|0.8314
71745369|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.39||0.0516|TWO_SIDED|95.0|-0.01|1.54|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)||1.54|-0.01|0.0516
71745370|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.42||0.3202|TWO_SIDED|95.0|-0.4|1.24|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.24|-0.40|0.3202
71745371|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.42||0.5893|TWO_SIDED|95.0|-0.6|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.05|-0.60|0.5893
71779047|NCT03855228|143058060|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71745372|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.42||0.651|TWO_SIDED|95.0|-0.63|1.01|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)||1.01|-0.63|0.6510
71745373|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.44||0.0796|TWO_SIDED|95.0|-0.09|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.62|-0.09|0.0796
71745374|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.44||0.5061|TWO_SIDED|95.0|-0.57|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.15|-0.57|0.5061
71745375|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.44||0.2796|TWO_SIDED|95.0|-0.38|1.33|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)||1.33|-0.38|0.2796
71745376|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.45||0.6725|TWO_SIDED|95.0|-0.69|1.08|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.08|-0.69|0.6725
71745377|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.45||0.6381|TWO_SIDED|95.0|-1.1|0.67|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||0.67|-1.10|0.6381
71745378|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.45||0.3737|TWO_SIDED|95.0|-0.49|1.29|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)||1.29|-0.49|0.3737
71745379|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9139|TWO_SIDED|95.0|-0.87|0.97|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.97|-0.87|0.9139
71745380|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9998|TWO_SIDED|95.0|-0.92|0.92|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.92|-0.92|0.9998
71745381|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||0.9144|TWO_SIDED|95.0|-0.88|0.98|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)||0.98|-0.88|0.9144
71745382|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.51||0.225|TWO_SIDED|95.0|-0.38|1.61|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.61|-0.38|0.2250
71745383|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.2758|TWO_SIDED|95.0|-0.44|1.55|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.55|-0.44|0.2758
71745384|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.51||0.903|TWO_SIDED|95.0|-0.94|1.06|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)||1.06|-0.94|0.9030
71745385|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.53||0.091|TWO_SIDED|95.0|-0.14|1.94|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.94|-0.14|0.0910
71745386|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.53||0.7668|TWO_SIDED|95.0|-0.88|1.2|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.20|-0.88|0.7668
71745387|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.53||0.1653|TWO_SIDED|95.0|-0.31|1.78|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)||1.78|-0.31|0.1653
71745388|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.55||0.4323|TWO_SIDED|95.0|-0.65|1.52|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||1.52|-0.65|0.4323
71745389|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.55||0.1439|TWO_SIDED|95.0|-1.89|0.28|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||0.28|-1.89|0.1439
71745390|NCT00346216|143001646|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.55||0.0251|TWO_SIDED|95.0|0.16|2.33|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)||2.33|0.16|0.0251
71745391|NCT00904813|143001647|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.38||||0.52|TWO_SIDED|90.0|0.06|2.56||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group. Estimation described above is for SRT-delay. For LRT-delay HR (90% CI) was 1.22 with lower limit: 0.33, and upper limit: 3.45.|The effect of treatment regimen on local recurrence as first event in the three-armed group comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||2.56|0.06|0.52
71745392|NCT00904813|143001647|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.93||||0.92|TWO_SIDED|95.0|0.64|1.35||The threshold for statistical significance was p=0.05.|Log Rank|An overall p-value was calculated.|SRT was used as reference group (1.00). Estimation described above is for SRT-delay. For LRT-delay HR (95% CI) was 0.99 with lower limit: 0.68, and upper limit: 1.42.|The effect of treatment regimen on recurrence-free survival in the three armed randomisation comparison (n = 385) was estimated with proportional hazards regression, stratified by participating centre.||1.35|0.64|0.92
71779048|NCT03855228|143058060|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779049|NCT03855228|143058060|SUPERIORITY|||||||0.22|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.22
71779050|NCT03855228|143058061|SUPERIORITY|||||||0.65|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.65
71779051|NCT03855228|143058061|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71745393|NCT00904813|143001647|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.91||||0.59|TWO_SIDED|90.0|0.36|2.27||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group (1.00). Estimation described above is for SRT-delay.|The effect of treatment regimen on local recurrence as first event in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||2.27|0.36|0.59
71745394|NCT00904813|143001647|NON_INFERIORITY|In the initial protocol treatment groups were deemed non-inferior if the upper limit of a two-sided 90% CI for the hazard ratio did not exceed 1.7. With a cumulative incidence of local recurrence at 15%, a sample size of 840 participants were determined to provide a power of 80%. However, due to lower recurrence rate, the trial was re-powered in the amendment 1999 to deem non-inferiority at an HR not exceeding 2.5 or 3.6 depending on the frequency of local recurrence.|Hazard Ratio (HR)|0.9||||0.39|TWO_SIDED|95.0|0.69|1.18||The threshold for statistical significance was p=0.05.|Log Rank||SRT was used as reference group. Estimation described above is for SRT-delay.|The effect of treatment regimen on recurrence-free survival in the pooled short-course RT comparison (n = 712) was estimated with proportional hazards regression, stratified by participating centre.||1.18|0.69|0.39
71745395|NCT00904813|143001648|SUPERIORITY||Odds Ratio (OR)|0.72||||0.289|TWO_SIDED|95.0|0.4|1.32||The threshold of statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||1.32|0.40|0.289
71745396|NCT00904813|143001648|SUPERIORITY||Odds Ratio (OR)|0.5||||0.009|TWO_SIDED|95.0|0.3|0.84||The threshold for statistical significance was p=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.84|0.30|0.009
71745397|NCT00904813|143001648|SUPERIORITY||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.65||The threshold for statistical significance was p-value=0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group B was used as the reference group.|The association between postoperative complications and short-course RT by overall treatment time was assessed using logistic regression analysis.||0.65|0.23|<0.001
71745398|NCT00904813|143001648|SUPERIORITY||Odds Ratio (OR)|1.58||||0.521|TWO_SIDED|95.0|0.39|6.37||The threshold for statistical significance was p-value = 0.05.|Regression, Logistic|Model was adjusted for sex, age over 75 years, type of surgery and ASA fitness grade.|Group E was used as the reference group.|The association between postoperative complications and long-course RT by overall treatment time was assessed using logistic regression analysis.||6.37|0.39|0.521
71745399|NCT00904813|143001649|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.046|TWO_SIDED|95.0|0.26|0.99||The threshold for statistical significance was p=0.05.|Regression, Cox|Model adjusted for age, sex and type of surgery.|No pCR was used as reference group.|The association between pathological complete response (pCR), eg no signs of viable tumour or metastatic nodes (T0N0) and overall survival (OS) was assessed using Cox-regression model.||0.99|0.26|0.046
71745400|NCT02648204|143001651|NON_INFERIORITY|Non-Inferiority margin: 0.4|Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
71745401|NCT02648204|143001651|SUPERIORITY||Treatment difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.55|-0.25|||Mixed Models Analysis|||||-0.25|-0.55|<0.0001
71745402|NCT02648204|143001651|NON_INFERIORITY|Non-Inferiority margin: 0.04|Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
71745403|NCT02648204|143001651|SUPERIORITY||Treatment difference|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.57|-0.25|||Mixed Models Analysis|||||-0.25|-0.57|<0.0001
71745404|NCT02648204|143001652|SUPERIORITY||Treatment difference|-2.26|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-3.02|-1.51|||Mixed Models Analysis|||||-1.51|-3.02|<0.0001
71745405|NCT02648204|143001652|SUPERIORITY||Treatment difference|-3.55|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-4.32|-2.78|||Mixed Models Analysis|||||-2.78|-4.32|<0.0001
71745406|NCT02341235|143001682|SUPERIORITY|||||||0.35|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.35
71745407|NCT02341235|143001683|SUPERIORITY|||||||0.22|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||0.22
71745408|NCT02341235|143001684|SUPERIORITY|||||||0.97|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.97
71745409|NCT02341235|143001685|SUPERIORITY|||||||0.98|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.98
71745410|NCT02341235|143001686|SUPERIORITY|||||||0.83|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.83
71745411|NCT02341235|143001687|SUPERIORITY|||||||0.055|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.055
71745412|NCT02341235|143001688|SUPERIORITY|||||||0.71|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.71
71779052|NCT03855228|143058061|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779053|NCT03855228|143058061|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779054|NCT03855228|143058061|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779055|NCT03855228|143058061|SUPERIORITY|||||||0.92|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.92
71779056|NCT03855228|143058062|SUPERIORITY|||||||0.95|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.95
71779057|NCT03855228|143058062|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
71779058|NCT03855228|143058062|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779059|NCT03855228|143058062|SUPERIORITY|||||||0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.01
71779060|NCT03855228|143058062|SUPERIORITY||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.||||<0.01
71779061|NCT03855228|143058062|SUPERIORITY|||||||0.58|||||||ANOVA|||This analysis compares Change From Baseline values.||||0.58
71779062|NCT03855228|143058063|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
71779063|NCT03855228|143058063|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71891004|NCT03068715|143304060|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.468|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.468
71665731|NCT03922529|142845806|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8936|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline value of the outcome as a covariate using linear mixed models and multiple imputation for missing data.|The adjusted difference from a model may not necessarily match the raw difference between groups.|||||0.8936
71779064|NCT03855228|143058063|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779065|NCT03855228|143058063|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779066|NCT03855228|143058063|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779067|NCT03855228|143058063|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.80
71779068|NCT03855228|143058064|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
71779069|NCT03855228|143058064|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779070|NCT03855228|143058064|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779071|NCT03855228|143058064|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779072|NCT03855228|143058064|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71779073|NCT03855228|143058064|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
71779074|NCT03104543|143058069|SUPERIORITY||Risk Ratio (RR)|0.99||||0.05|TWO_SIDED|95.0|0.67|1.45|||Generalized estimating equation|||||1.45|0.67|.05
71779075|NCT03104543|143058072|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.05|TWO_SIDED|95.0|-0.47|0.28|||t-test, 2 sided|||||0.28|-0.47|.05
71779076|NCT01682954|143058095|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
71779077|NCT01682954|143058096|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
71779078|NCT01696071|143058102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.038|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 QD - Tio R2.5 BID|No p-values are presented as no formal statistical hypothesis was tested.||0.034|-0.038|
71779079|NCT01696071|143058103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.021||||95.0|-0.032|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.052|-0.032|
71779080|NCT01696071|143058104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.05|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.022|-0.050|
71779081|NCT01696071|143058105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.018||||95.0|-0.051|0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.023|-0.051|
71779082|NCT01696071|143058106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||||95.0|-0.06|0.068|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.068|-0.060|
71779083|NCT01696071|143058107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.044|0.035|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.||0.035|-0.044|
71779084|NCT01696071|143058108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.048|0.042|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.042|-0.048|
71779085|NCT01696071|143058109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.047|0.034|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.034|-0.047|
71779086|NCT01696071|143058110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.07|0.032|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.032|-0.070|
71891005|NCT03068715|143304060|SUPERIORITY|FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis. sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas.|||||=|0.486|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.486
71665732|NCT03922529|142845807|SUPERIORITY|||||||0.2794|||||||Chi-squared|||||||0.2794
71745413|NCT02341235|143001689|SUPERIORITY|||||||0.33|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.33
71779087|NCT01696071|143058111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.03|0.111|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||0.111|-0.030|
71779088|NCT01696071|143058112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.389|STANDARD_ERROR_OF_MEAN|3.658||||95.0|-8.651|5.873|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline|Tio R5 qd - Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested||5.873|-8.651|
71779089|NCT03320057|143058139|OTHER|We conducted multivariable logistic regression analyses using Generalized Estimating Equation (GEE) models to assess whether study implementation was associated with pharmacists' overall medication abortion knowledge. Multivariable GEE analyses included time period (baseline and endline) as the primary independent variable, adjusted for gender and years of experience, and accounted for clustering by pharmacy site and individual pharmacist.|Beta Coefficient|0.14|||<|0.05|TWO_SIDED|95.0|0.11|0.17|||Regression, Linear||Coefficients in adjusted analyses examining overall medication abortion knowledge represent the difference in mean knowledge scores between baseline and endline.|Medication abortion knowledge scores were based on a set of 15 items. We first assessed the internal consistency reliability of the 15 knowledge items and considered a Cronbach's alpha coefficient above .70 to be acceptable to examine the items as a combined score.||0.17|0.11|<0.05
71779090|NCT00717093|143058151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.59|3.58||p-values obtained from logistic regression model including main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values imputed as negative|Odds ratio obtained from logistic regression model including main effects of treatment and center|||3.58|1.59|<0.0001
71779091|NCT00717093|143058152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0118|TWO_SIDED|95.0|1.12|2.58||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values were imputed as negative|Odds Ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.58|1.12|0.0118
71779092|NCT00717093|143058153|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.0063|TWO_SIDED|95.0|1.17|2.67|||Regression, Logistic|Missing salivary cotinine values were imputed as negative.||||2.67|1.17|0.0063
71779093|NCT00717093|143058154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.52|3.41||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 12||3.41|1.52|<0.0001
71665733|NCT03922529|142845808|SUPERIORITY|||||||0.6177|||||||Chi-squared|||||||0.6177
71665734|NCT03922529|142845809|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||0.1440
71665735|NCT03922529|142845810|SUPERIORITY|||||||0.1122|||||||Chi-squared|||||||0.1122
71665736|NCT03922529|142845811|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9653|TWO_SIDED|95.0|0.63|1.62|||Regression, Logistic|||||1.62|0.63|0.9653
71665737|NCT01277601|142845824|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||< 0.001
71665738|NCT01277601|142845824|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank|||||||0.002
71665739|NCT02291510|142845838|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.4|||<|0.001|TWO_SIDED|90.0|32.27|38.74|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||38.74|32.27|<0.001
71665740|NCT02291510|142845838|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.3|||<|0.001|TWO_SIDED|90.0|47.77|57.36|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||57.36|47.77|<0.001
71745414|NCT02341235|143001690|SUPERIORITY|||||||0.94|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.94
71745415|NCT02341235|143001691|SUPERIORITY|||||||0.57|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.57
71745416|NCT02341235|143001692|SUPERIORITY|||||||0.3|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.30
71745417|NCT02341235|143001693|SUPERIORITY|||||||0.44|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.44
71745418|NCT02341235|143001694|SUPERIORITY|||||||0.62|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.62
71779094|NCT00717093|143058154|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0919|TWO_SIDED|95.0|0.94|2.13||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26||2.13|0.94|0.0919
71779095|NCT01650844|143058170|OTHER|We estimated the power to detect the smallest clinically significant difference in mean SFDs post intervention between the groups, accounting for repeated measures. A sample of 400 obtains greater than 90% power to detect a difference of 0.8 SFD per 2 weeks or greater. Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.8|<|0.05|TWO_SIDED|||||Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Regression, Linear|||||||<0.05
71779096|NCT03689530|143058197|SUPERIORITY|||||||0.7436|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.7436
71779097|NCT03689530|143058198|SUPERIORITY|||||||0.1212|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1212
71665741|NCT02291510|142845838|SUPERIORITY_OR_OTHER||% Ratio of LS Means|32.1|||<|0.001|TWO_SIDED|90.0|29.3|35.18|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||35.18|29.30|<0.001
71665742|NCT02291510|142845838|SUPERIORITY_OR_OTHER||% Ratio of LS Means|47.5|||<|0.001|TWO_SIDED|90.0|43.38|52.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||52.09|43.38|<0.001
71665743|NCT02291510|142845838|SUPERIORITY_OR_OTHER||% Ratio of LS Means|110.1||||0.0832|TWO_SIDED|90.0|100.5|120.68|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||120.68|100.50|0.0832
71779098|NCT03689530|143058199|SUPERIORITY|||||||0.8839|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8839
71745419|NCT02341235|143001695|SUPERIORITY|||||||0.7|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.70
71745420|NCT02341235|143001696|SUPERIORITY|||||||0.41|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.41
71745421|NCT02341235|143001697|SUPERIORITY|||||||0.72|||||||ANCOVA|||All analyses were adjusted for baseline values, age, race, ethnicity, and time since diagnosis.||||.72
71745422|NCT02341235|143001704|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
71745423|NCT02341235|143001706|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.580
71745424|NCT02341235|143001714|SUPERIORITY|||||||0.461|||||||ANCOVA|||||||0.461
71745425|NCT02341235|143001716|SUPERIORITY|||||||0.934|||||||ANCOVA|||||||0.934
71745426|NCT04862065|143001750|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
71745427|NCT04862065|143001751|OTHER|95% Confidence Interval provided|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
71745428|NCT04862065|143001752|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
71779099|NCT03689530|143058200|SUPERIORITY|||||||0.1137|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1137
71745429|NCT03170661|143001757|SUPERIORITY|||||||0.94|||||||GEEGLM|Effects of GEEGLM covariates: surgeon, p = 0.24; surgery length, p= 0.73 and body mass index, p= 0.22).||||||0.94
71665744|NCT02291510|142845839|SUPERIORITY_OR_OTHER||% Ratio of LS Means|35.9|||<|0.001|TWO_SIDED|90.0|32.43|39.77|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||39.77|32.43|<0.001
71665745|NCT02291510|142845839|SUPERIORITY_OR_OTHER||% Ratio of LS Means|53.0|||<|0.001|TWO_SIDED|90.0|47.88|58.71|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||58.71|47.88|<0.001
71745430|NCT03001557|143001766|SUPERIORITY||Least square mean (LSM) difference|3.177||||0.1099|TWO_SIDED|95.0|-0.741|7.096||Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.096|-0.741|0.1099
71745431|NCT03001557|143001766|SUPERIORITY||LSM Difference|2.802||||0.1576|TWO_SIDED|95.0|-1.119|6.723||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.723|-1.119|0.1576
71745432|NCT03001557|143001766|SUPERIORITY||LSM Difference|-0.96||||0.616|TWO_SIDED|95.0|-4.777|2.857||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.857|-4.777|0.6160
71745433|NCT03001557|143001766|SUPERIORITY||LSM Difference|0.713||||0.7135|TWO_SIDED|95.0|-3.16|4.585||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||4.585|-3.160|0.7135
71745434|NCT03001557|143001770|SUPERIORITY||LSM Difference|-5.098||||0.1582|TWO_SIDED|95.0|-12.24|2.045||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.045|-12.240|0.1582
71745435|NCT03001557|143001770|SUPERIORITY||LSM Difference|-6.105||||0.0961|TWO_SIDED|95.0|-13.332|1.122||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.122|-13.332|0.0961
71745436|NCT03001557|143001770|SUPERIORITY||LSM Difference|0.68||||0.8449|TWO_SIDED|95.0|-6.262|7.623||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.623|-6.262|0.8449
71745437|NCT03001557|143001770|SUPERIORITY||LSM Difference|-3.14||||0.3747|TWO_SIDED|95.0|-10.178|3.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.897|-10.178|0.3747
71745438|NCT03001557|143001774|SUPERIORITY||LSM Difference|1.932||||0.3966|TWO_SIDED|95.0|-2.601|6.465||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.465|-2.601|0.3966
71745439|NCT03001557|143001774|SUPERIORITY||LSM Difference|3.386||||0.1381|TWO_SIDED|95.0|-1.125|7.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||7.897|-1.125|0.1381
71745440|NCT03001557|143001774|SUPERIORITY||LSM Difference|1.337||||0.5487|TWO_SIDED|95.0|-3.104|5.778||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||5.778|-3.104|0.5487
71745441|NCT03001557|143001774|SUPERIORITY||LSM Difference|4.32||||0.0581|TWO_SIDED|95.0|-0.153|8.793||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||8.793|-0.153|0.0581
71745442|NCT03001557|143001778|SUPERIORITY||LSM Difference|-3.437||||0.1777|TWO_SIDED|95.0|-8.481|1.608||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.608|-8.481|0.1777
71779100|NCT03689530|143058201|SUPERIORITY|||||||0.0162|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0162
71779101|NCT03689530|143058203|SUPERIORITY|||||||0.2117|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.2117
71779102|NCT03689530|143058204|SUPERIORITY|||||||0.4169|||||||Mixed Models Analysis|||||||0.4169
71779103|NCT03689530|143058205|SUPERIORITY|||||||0.8785|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.8785
71745443|NCT03001557|143001778|SUPERIORITY||LSM Difference|1.458||||0.563|TWO_SIDED|95.0|-3.564|6.479||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||6.479|-3.564|0.5630
71779104|NCT03689530|143058206|SUPERIORITY|||||||0.1006|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.1006
71779105|NCT03689530|143058207|SUPERIORITY|||||||0.7168|||||||Mixed Models Analysis|||||||0.7168
71779106|NCT03689530|143058208|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Outcomes were analyzed using multilevel models adapted for partially clustered data. Analyses was done in SAS v9.4||||0.0001
71779107|NCT03689530|143058209|OTHER|Single group analysis for peer support group only|Mean|3.799|STANDARD_DEVIATION|0.885|||TWO_SIDED|||||||||||||
71779108|NCT03689530|143058210|OTHER|Single group analysis for peer support group only|Mean|3.732|STANDARD_DEVIATION|0.985|||TWO_SIDED|||||||||||||
71779109|NCT03689530|143058211|OTHER|Single group analysis for peer support group only|Mean|6.222|STANDARD_DEVIATION|1.083|||TWO_SIDED|||||||||||||
71779110|NCT03689530|143058212|OTHER|Single group analysis for peer support group only|Mean|6.179|STANDARD_DEVIATION|1.141|||TWO_SIDED|||||||||||||
71779111|NCT03689530|143058213|SUPERIORITY|||||||0.9126|||||||Mixed Models Analysis|||||||0.9126
71779112|NCT03689530|143058214|SUPERIORITY|||||||0.7405|||||||Mixed Models Analysis|||||||0.7405
71745444|NCT03001557|143001778|SUPERIORITY||LSM Difference|-4.994||||0.0482|TWO_SIDED|95.0|-9.946|-0.041||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-0.041|-9.946|0.0482
71779113|NCT03689530|143058215|SUPERIORITY|||||||0.5956|||||||Mixed Models Analysis|||||||0.5956
71779114|NCT03689530|143058216|SUPERIORITY|||||||0.3341|||||||Mixed Models Analysis|||||||0.3341
71779115|NCT03689530|143058217|SUPERIORITY|||||||0.2049|||||||Mixed Models Analysis|||||||0.2049
71779116|NCT03689530|143058218|SUPERIORITY|||||||0.0335|||||||Mixed Models Analysis|||||||0.0335
71745445|NCT03001557|143001778|SUPERIORITY||LSM Difference|-2.593||||0.3036|TWO_SIDED|95.0|-7.599|2.413||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.413|-7.599|0.3036
71745446|NCT03001557|143001782|SUPERIORITY||LSM Difference|4.845||||0.1991|TWO_SIDED|95.0|-2.624|12.313||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||12.313|-2.624|0.1991
71779117|NCT03689530|143058219|SUPERIORITY|||||||0.3219|||||||Mixed Models Analysis|||||||0.3219
71779118|NCT03689530|143058220|SUPERIORITY|||||||0.5223|||||||Mixed Models Analysis|||||||0.5223
71779119|NCT01392443|143058221|OTHER|||||||0.0007|||||||single-sample biniminal test|||||||0.0007
71779120|NCT01895062|143058226|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.022
71779121|NCT01977794|143058230|SUPERIORITY_OR_OTHER||||||<|0.001||||||P value in both groups (Amlodipine failed and Bisoprolol failed) for comparison of SBP after 18 weeks versus baseline|Paired t test|||For each group (Amlodipine failed and Bisoprolol failed) SBP after 18 weeks compared to baseline (under monotherapy). Superiority was assessed between FDC and monotherapies.||||<0.001
71779122|NCT02555683|143058235|SUPERIORITY||rate ratio|1.04||||0.8|TWO_SIDED|95.0|0.77|1.41||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.41|0.77|0.800
71779123|NCT02555683|143058235|SUPERIORITY||Rate Ratio|0.83||||0.51|TWO_SIDED|95.0|0.61|1.14||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.14|0.61|0.510
71779124|NCT02555683|143058236|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.095||0.819|TWO_SIDED|95.0|-0.11|0.26||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.26|-0.11|0.819
71779125|NCT02555683|143058236|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.095||0.591|TWO_SIDED|95.0|-0.05|0.32||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.32|-0.05|0.591
71779126|NCT02555683|143058237|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.098||0.819|TWO_SIDED|95.0|-0.31|0.07||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.07|-0.31|0.819
71779127|NCT02555683|143058237|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.098||0.591|TWO_SIDED|95.0|-0.37|0.02||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.02|-0.37|0.591
71779128|NCT02555683|143058238|SUPERIORITY||Mean Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.0365||0.8|TWO_SIDED|95.0|-0.005|0.139||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.139|-0.005|0.800
71779129|NCT02555683|143058238|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0363||0.523|TWO_SIDED|95.0|-0.021|0.121||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.121|-0.021|0.523
71779130|NCT02555683|143058239|SUPERIORITY||rate ratio|0.96||||0.819|TWO_SIDED|95.0|0.75|1.22||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure||||1.22|0.75|0.819
71779131|NCT02555683|143058239|SUPERIORITY||Rate Ratio|0.78||||0.51|TWO_SIDED|95.0|0.61|1.01||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure||||1.01|0.61|0.510
71779132|NCT02555683|143058240|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.076||0.819|TWO_SIDED|95.0|-0.07|0.23||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.23|-0.07|0.819
71779133|NCT02555683|143058240|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.076||0.591|TWO_SIDED|95.0|-0.03|0.27||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.27|-0.03|0.591
71779134|NCT02555683|143058241|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.079||0.819|TWO_SIDED|95.0|-0.27|0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.04|-0.27|0.819
71779135|NCT02555683|143058241|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.079||0.591|TWO_SIDED|95.0|-0.35|-0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||-0.04|-0.35|0.591
71779136|NCT02555683|143058242|SUPERIORITY||Mean Difference (Net)|0.076|STANDARD_ERROR_OF_MEAN|0.0292||0.819|TWO_SIDED|95.0|0.019|0.134||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.134|0.019|0.819
71779137|NCT02555683|143058242|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.0292||0.591|TWO_SIDED|95.0|-0.017|0.097||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure||||0.097|-0.017|0.591
71779138|NCT03019185|143058263|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|13.37|STANDARD_ERROR_OF_MEAN|1.4111|<|0.0001|TWO_SIDED|95.0|10.48|16.27|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||16.27|10.48|<0.0001
71779139|NCT03019185|143058264|SUPERIORITY||LS Mean difference (Net)|9.49|STANDARD_ERROR_OF_MEAN|1.813|<|0.0001|TWO_SIDED|97.5|5.38|13.6|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||13.60|5.38|<0.0001
71779140|NCT03019185|143058265|SUPERIORITY||LS Mean difference (Net)|7.65|STANDARD_ERROR_OF_MEAN|2.144||0.0005|TWO_SIDED|95.0|3.41|11.89|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.|Difference is bardoxolone methyl - placebo|||11.89|3.41|0.0005
71779141|NCT03019185|143058266|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 48.|LS Mean change from baseline|7.4|STANDARD_ERROR_OF_MEAN|1.9451||0.0008|TWO_SIDED|95.0|3.4|11.39|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 48 were included. Missing data were not imputed.||||11.39|3.40|0.0008
71779142|NCT03019185|143058267|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 100.|LS Mean change from baseline|4.28|STANDARD_ERROR_OF_MEAN|1.7484||0.015|TWO_SIDED|95.0|0.84|7.72|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 100 (excluding Week 52) were included. Missing data were not imputed.||||7.72|0.84|0.0150
71779143|NCT03019185|143058268|SUPERIORITY||LS Mean difference (Net)|5.09|STANDARD_ERROR_OF_MEAN|1.656||0.0021|TWO_SIDED|97.5|1.37|8.8|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||8.80|1.37|0.0021
71779144|NCT03019185|143058269|SUPERIORITY||LS Mean difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|1.876||0.0232|TWO_SIDED|95.0|0.58|7.94|||ANCOVA|Missing eGFR data were imputed using multiple imputation based on the treatment group to which the patient was assigned.|Difference is bardoxolone methyl - placebo|||7.94|0.58|0.0232
71779145|NCT03355365|143058274|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71834667|NCT05028582|143173873|SUPERIORITY|PSD Pain Week 8|Odds Ratio (OR)|3.23|||<|0.0001|TWO_SIDED|97.5|1.83|5.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||5.68|1.83|<0.0001
71834668|NCT05028582|143173874|SUPERIORITY|PSD Scaling Week 8|Odds Ratio (OR)|4.56|||<|0.0001|TWO_SIDED|97.5|2.28|9.08|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.08|2.28|<0.0001
71834669|NCT05028582|143173875|OTHER|PSD Total Score 0 at Week 8|Odds Ratio (OR)|3.27||||0.0012|TWO_SIDED|97.5|1.39|7.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA|||7.68|1.39|0.0012
71834670|NCT05028582|143173876|SUPERIORITY|PSSI-75 at Week 8|Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|97.5|2.98|9.77|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S IGA, and baseline B IGA with multiple imputation to handle missing data|||9.77|2.98|<0.0001
71779146|NCT03355365|143058275|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
71779147|NCT03355365|143058276|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71779148|NCT03355365|143058277|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71779149|NCT03355365|143058278|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||.43
71779150|NCT03355365|143058279|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71779151|NCT03355365|143058280|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71779152|NCT03355365|143058281|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||.71
71779153|NCT03355365|143058282|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71779154|NCT00142935|143058318|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||Outcome: engage in treatment post release, yes or no||||<0.001
71779155|NCT00142935|143058319|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared, Corrected|||||||.02
71779156|NCT00142935|143058320|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared, Corrected|||||||.09
71779157|NCT00142935|143058321|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared, Corrected|||||||.09
71779158|NCT00142935|143058323|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared, Corrected|||||||0.8
71779159|NCT03228433|143058351|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).|Least Squares (LS) Mean Difference|0.951|||||TWO_SIDED|90.0|0.823|1.099||||||||1.099|0.823|
71779160|NCT03228433|143058351|EQUIVALENCE|A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.14|||||TWO_SIDED|90.0|1.04|1.25||||||||1.25|1.04|
71779161|NCT03228433|143058352|EQUIVALENCE|Bioequivalence interval of 627.51 to 659.59|LS Mean Difference|0.951|||||TWO_SIDED|90.0|0.825|1.097||||||||1.097|0.825|
71834671|NCT05028582|143173877|SUPERIORITY|S-IGA Clear at Week 8|Odds Ratio (OR)|6.77|||<|0.0001|TWO_SIDED|97.5|3.04|15.05|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||15.05|3.04|<0.0001
71891006|NCT03068715|143304061|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.447|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving active iTBS.||||=0.447
71779162|NCT03228433|143058352|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.11|||||TWO_SIDED|90.0|1.0|1.22||||||||1.22|1.00|
71779163|NCT03228433|143058353|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.|LS Mean Difference|0.58|||||TWO_SIDED|90.0|0.431|0.781||||||||0.781|0.431|
71779164|NCT03228433|143058353|EQUIVALENCE|A linear regression model (power model), ln (parameter) = intercept + slope\*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 - ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.06||||||90.0|0.96|1.17||||||||1.17|0.96|
71779165|NCT01773733|143058356|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71779166|NCT02609828|143058368|SUPERIORITY||Differences in least square (LS) mean|-0.78|STANDARD_ERROR_OF_MEAN|0.37||0.0381|TWO_SIDED|95.0|-1.52|-0.04|||ANCOVA|||Change at Week 8: Analysis of covariance (ANCOVA) model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.04|-1.52|0.0381
71779167|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0497|TWO_SIDED|95.0|-0.72|0.0|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.00|-0.72|0.0497
71779168|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.66|STANDARD_ERROR_OF_MEAN|0.25||0.0092|TWO_SIDED|95.0|-1.16|-0.17|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.16|0.0092
71779169|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.32||0.0218|TWO_SIDED|95.0|-1.37|-0.11|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.11|-1.37|0.0218
71779170|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.87|STANDARD_ERROR_OF_MEAN|0.36||0.0154|TWO_SIDED|95.0|-1.58|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.58|0.0154
71779171|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.39||0.1289|TWO_SIDED|95.0|-1.36|0.17|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.36|0.1289
71779172|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|0.44||0.211|TWO_SIDED|95.0|-1.43|0.32|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.43|0.2110
71779173|NCT02609828|143058369|SUPERIORITY||Difference in LS mean|-0.58|STANDARD_ERROR_OF_MEAN|0.46||0.2049|TWO_SIDED|95.0|-1.49|0.32|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.32|-1.49|0.2049
71779174|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1103|TWO_SIDED|95.0|-0.73|0.07|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.07|-0.73|0.1103
71779175|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.73|STANDARD_ERROR_OF_MEAN|0.27||0.0084|TWO_SIDED|95.0|-1.26|-0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.19|-1.26|0.0084
71891007|NCT03068715|143304061|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.115|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lsgACC\_lDMN in participants receiving sham iTBS.||||=0.115
71745447|NCT03001557|143001782|SUPERIORITY||LSM Difference|-3.872||||0.2982|TWO_SIDED|95.0|-11.263|3.518||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||3.518|-11.263|0.2982
71745448|NCT03001557|143001782|SUPERIORITY||LSM Difference|6.776||||0.0664|TWO_SIDED|95.0|-0.474|14.025||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||14.025|-0.474|0.0664
71745449|NCT03001557|143001782|SUPERIORITY||LSM Difference|3.017||||0.4148|TWO_SIDED|95.0|-4.344|10.379||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||10.379|-4.344|0.4148
71745450|NCT03001557|143001786|SUPERIORITY||LSM Difference|0.063||||0.9599|TWO_SIDED|95.0|-2.452|2.579||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.579|-2.452|0.9599
71745451|NCT03001557|143001786|SUPERIORITY||LSM Difference|-0.238||||0.8541|TWO_SIDED|95.0|-2.817|2.342||Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.|MMRM|||||2.342|-2.817|0.8541
71745452|NCT03001557|143001786|SUPERIORITY||LSM Difference|-0.293||||0.8117|TWO_SIDED|95.0|-2.745|2.16||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2.160|-2.745|0.8117
71745453|NCT03001557|143001786|SUPERIORITY||LSM Difference|-1.557||||0.2274|TWO_SIDED|95.0|-4.113|1.0||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1.000|-4.113|0.2274
71745454|NCT03001557|143001790|SUPERIORITY||LSM Difference|0.086||||0.2421|TWO_SIDED|95.0|-0.06|0.232||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.232|-0.060|0.2421
71745455|NCT03001557|143001790|SUPERIORITY||LSM Difference|-0.012||||0.8661|TWO_SIDED|95.0|-0.155|0.131||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.131|-0.155|0.8661
71745456|NCT03001557|143001790|SUPERIORITY||LSM Difference|0.057||||0.4251|TWO_SIDED|95.0|-0.085|0.199||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.199|-0.085|0.4251
71745457|NCT03001557|143001790|SUPERIORITY||LSM Difference|0.025||||0.7248|TWO_SIDED|95.0|-0.116|0.166||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.166|-0.116|0.7248
71745458|NCT03001557|143001794|SUPERIORITY||LSM Difference|-0.032||||0.2991|TWO_SIDED|95.0|-0.094|0.029||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.029|-0.094|0.2991
71745459|NCT03001557|143001794|SUPERIORITY||LSM Difference|0.033||||0.2861|TWO_SIDED|95.0|-0.028|0.095||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.095|-0.028|0.2861
71745460|NCT03001557|143001794|SUPERIORITY||LSM Difference|-0.052||||0.0938|TWO_SIDED|95.0|-0.113|0.009||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.009|-0.113|0.0938
71745461|NCT03001557|143001794|SUPERIORITY||LSM Difference|0.005||||0.8618|TWO_SIDED|95.0|-0.055|0.066||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.066|-0.055|0.8618
71745462|NCT03001557|143001798|SUPERIORITY||LSM Difference|-389.873||||0.0294|TWO_SIDED|95.0|-739.177|-40.569||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-40.569|-739.177|0.0294
71745463|NCT03001557|143001798|SUPERIORITY||LSM Difference|-402.994||||0.0243|TWO_SIDED|95.0|-751.67|-54.319||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-54.319|-751.670|0.0243
71745464|NCT03001557|143001798|SUPERIORITY||LSM Difference|-141.026||||0.4209|TWO_SIDED|95.0|-489.805|207.752||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||207.752|-489.805|0.4209
71745465|NCT03001557|143001798|SUPERIORITY||LSM Difference|-367.845||||0.0398|TWO_SIDED|95.0|-717.87|-17.82||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||-17.820|-717.870|0.0398
71745466|NCT03001557|143001802|SUPERIORITY||LSM Difference|-1276.18||||0.1162|TWO_SIDED|95.0|-2878.587|326.226||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||326.226|-2878.587|0.1162
71745467|NCT03001557|143001802|SUPERIORITY||LSM Difference|227.464||||0.7781|TWO_SIDED|95.0|-1382.85|1837.777||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1837.777|-1382.850|0.7781
71745468|NCT03001557|143001802|SUPERIORITY||LSM Difference|-620.581||||0.4255|TWO_SIDED|95.0|-2170.342|929.179||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||929.179|-2170.342|0.4255
71745469|NCT03001557|143001802|SUPERIORITY||LSM Difference|-577.82||||0.4672|TWO_SIDED|95.0|-2160.337|1004.697||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1004.697|-2160.337|0.4672
71745470|NCT03001557|143001806|SUPERIORITY||LSM Difference|-839.088||||0.2984|TWO_SIDED|95.0|-2440.854|762.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||762.678|-2440.854|0.2984
71745471|NCT03001557|143001806|SUPERIORITY||LSM Difference|651.922||||0.4218|TWO_SIDED|95.0|-962.835|2266.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||2266.678|-962.835|0.4218
71745472|NCT03001557|143001806|SUPERIORITY||LSM Difference|-447.245||||0.5655|TWO_SIDED|95.0|-1998.44|1103.95||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1103.950|-1998.440|0.5655
71745473|NCT03001557|143001806|SUPERIORITY||LSM Difference|-130.603||||0.8686|TWO_SIDED|95.0|-1706.478|1445.272||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||1445.272|-1706.478|0.8686
71745474|NCT03001557|143001810|SUPERIORITY||LSM Difference|0.02||||0.4638|TWO_SIDED|95.0|-0.034|0.074||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.074|-0.034|0.4638
71745475|NCT03001557|143001810|SUPERIORITY||LSM Difference|0.06||||0.0322|TWO_SIDED|95.0|0.005|0.115||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.115|0.005|0.0322
71745476|NCT03001557|143001810|SUPERIORITY||LSM Difference|0.003||||0.9144|TWO_SIDED|95.0|-0.051|0.056||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM|||||0.056|-0.051|0.9144
71779176|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.75|STANDARD_ERROR_OF_MEAN|0.33||0.0236|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|||Change at Week 4:ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.10|-1.39|0.0236
71779177|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.36||0.0155|TWO_SIDED|95.0|-1.59|-0.17|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||-0.17|-1.59|0.0155
71779178|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.76|STANDARD_ERROR_OF_MEAN|0.38||0.0505|TWO_SIDED|95.0|-1.52|0.0|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.00|-1.52|0.0505
71779179|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.72|STANDARD_ERROR_OF_MEAN|0.4||0.0761|TWO_SIDED|95.0|-1.52|0.08|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.08|-1.52|0.0761
71779180|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.74|STANDARD_ERROR_OF_MEAN|0.48||0.1263|TWO_SIDED|95.0|-1.7|0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.21|-1.70|0.1263
71779181|NCT02609828|143058370|SUPERIORITY||Difference in LS mean|-0.79|STANDARD_ERROR_OF_MEAN|0.49||0.1051|TWO_SIDED|95.0|-1.76|0.17|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.17|-1.76|0.1051
71779182|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.3003|TWO_SIDED|95.0|-1.47|0.47|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.47|-1.47|0.3003
71779183|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-0.84|STANDARD_ERROR_OF_MEAN|0.59||0.1603|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.35|-2.03|0.1603
71779184|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2298|TWO_SIDED|95.0|-2.13|0.53|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.53|-2.13|0.2298
71779185|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5054|TWO_SIDED|95.0|-1.93|0.97|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.97|-1.93|0.5054
71779186|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-0.55|STANDARD_ERROR_OF_MEAN|-0.77||0.4793|TWO_SIDED|95.0|-2.1|1.01|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||1.01|-2.10|0.4793
71779187|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.66||0.4496|TWO_SIDED|95.0|-1.83|0.83|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.83|-1.83|0.4496
71779188|NCT02609828|143058371|SUPERIORITY||Difference in least square LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.77||0.1263|TWO_SIDED|95.0|-2.77|0.36|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.36|-2.77|0.1263
71779189|NCT02609828|143058371|SUPERIORITY||Difference in LS mean|-1.05|STANDARD_ERROR_OF_MEAN|0.73||0.162|TWO_SIDED|95.0|-2.54|0.44|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site and baseline opioid dose as covariates.||0.44|-2.54|0.1620
71665746|NCT02291510|142845839|SUPERIORITY_OR_OTHER||% Ratio of LS Means|45.3|||<|0.001|TWO_SIDED|90.0|40.88|50.13|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||50.13|40.88|<0.001
71665747|NCT02291510|142845839|SUPERIORITY_OR_OTHER||% Ratio of LS Means|66.8|||<|0.001|TWO_SIDED|90.0|60.34|74.0|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||74.00|60.34|<0.001
71665748|NCT02291510|142845839|SUPERIORITY_OR_OTHER||% Ratio of LS Means|79.3||||0.0004|TWO_SIDED|90.0|71.65|87.86|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.||87.86|71.65|0.0004
71665749|NCT01272037|142845856|OTHER||Hazard Ratio (HR)|1.02||||0.35|TWO_SIDED|95.0|0.98|1.05|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*recurrence score interaction term.||This test describes the interaction of the treatment arm with the recurrence score in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on the recurrence score. If the interaction was statistically significant, the interaction term was planned to be included in the Cox model to evaluate the invasive disease-free survival outcome.||1.05|0.98|0.35
71665750|NCT01272037|142845856|OTHER||Hazard Ratio (HR)|1.71||||0.008|TWO_SIDED|95.0|1.15|2.54|||Regression, Cox|A Cox model was used that included treatment arm, recurrence score, menopausal status, and the chemotherapy\*menopausal status interaction term.||This test describes the interaction of the treatment arm with menopausal status (one of the study stratification factors) in the analysis of invasive disease-free survival in the overall study population, to determine whether chemotherapy benefit depends on menopausal status. If the interaction was statistically significant, separate analyses of IDFS were planned to be conducted by menopausal status.||2.54|1.15|0.008
71745477|NCT03001557|143001810|SUPERIORITY||LSM Difference|0.057||||0.0364|TWO_SIDED|95.0|0.004|0.11||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction|MMRM|||||0.110|0.004|0.0364
71745478|NCT01794000|143001816|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.83||||0.117|TWO_SIDED|95.0|0.66|1.05|||Andersen-Gill model||The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.|The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.||1.05|0.66|.117
71745479|NCT01794000|143001817|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.242||||0.912|TWO_SIDED|95.0|-4.564|4.079||Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.079|-4.564|.912
71745480|NCT01794000|143001818|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.0968||||0.365|TWO_SIDED|95.0|-0.1132|0.3068||MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||0.3068|-0.1132|.365
71745481|NCT01794000|143001819|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.82||||0.109|TWO_SIDED|95.0|0.65|1.04||The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.|Andersen-Gill Model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.04|0.65|.109
71745482|NCT01794000|143001820|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.94||||0.759|TWO_SIDED|95.0|0.65|1.37||The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.37|0.65|.759
71745483|NCT01794000|143001821|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.96||||0.916|TWO_SIDED|95.0|0.48|1.93||The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.93|0.48|.916
71745484|NCT01794000|143001822|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|1.17||||0.544|TWO_SIDED|95.0|0.71|1.91||The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.|||1.91|0.71|.544
71745485|NCT01794000|143001823|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.513||||0.602|TWO_SIDED|95.0|-4.186|7.213||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||7.213|-4.186|.602
71745486|NCT01794000|143001824|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|1.272||||0.459|TWO_SIDED|95.0|-2.109|4.652||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.|||4.652|-2.109|.459
71745487|NCT01794000|143001826|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|0.94||||0.662|TWO_SIDED|95.0|-3.31|5.19||The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.|ANCOVA||The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.|||5.19|-3.31|.662
71779190|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0575|TWO_SIDED|95.0|-2.17|0.04|||ANCOVA|||Change at Week 1: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.04|-2.17|0.0575
71745488|NCT01794000|143001827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.317|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the First VOC||||.317
71779191|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-1.96|STANDARD_ERROR_OF_MEAN|0.62||0.0031|TWO_SIDED|95.0|-3.22|-0.7|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.70|-3.22|0.0031
71779192|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-1.44|STANDARD_ERROR_OF_MEAN|0.68||0.041|TWO_SIDED|95.0|-2.82|-0.06|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.06|-2.82|0.0410
71779193|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-0.88|STANDARD_ERROR_OF_MEAN|0.77||0.2598|TWO_SIDED|95.0|-2.44|0.68|||ANCOVA|||Change at Week 6: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.68|-2.44|0.2598
71745489|NCT01794000|143001827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the Second VOC||||.133
71745490|NCT01794000|143001828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.638|||||||Fisher Exact|||||||.638
71745491|NCT00657046|143001857|SUPERIORITY_OR_OTHER|||||||0.693|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.693
71745492|NCT00657046|143001857|SUPERIORITY_OR_OTHER|||||||0.807|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.807
71745493|NCT00657046|143001858|SUPERIORITY_OR_OTHER|||||||0.212|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.212
71745494|NCT00657046|143001858|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.230
71745495|NCT00657046|143001859|SUPERIORITY_OR_OTHER|||||||0.712|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.712
71745496|NCT00657046|143001859|SUPERIORITY_OR_OTHER|||||||0.607|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.607
71745497|NCT00657046|143001860|SUPERIORITY_OR_OTHER|||||||0.4602|||||||ANCOVA|GLM model with baseline as a covariate||||||0.4602
71779194|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-0.77|STANDARD_ERROR_OF_MEAN|0.8||0.3426|TWO_SIDED|95.0|-2.38|0.85|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.85|-2.38|0.3426
71745498|NCT00657046|143001860|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|GLM model with baseline as a covariate||||||0.940
71745499|NCT00657046|143001861|SUPERIORITY_OR_OTHER|||||||0.376|||||||ANCOVA|GLM model with baseline as a covariate||||||0.376
71745500|NCT00657046|143001861|SUPERIORITY_OR_OTHER|||||||0.903|||||||ANCOVA|GLM model with baseline as a covariate||||||0.903
71745501|NCT00657046|143001862|SUPERIORITY_OR_OTHER|||||||0.319|||||||ANCOVA|GLM model with baseline as a covariate||||||0.319
71745502|NCT00657046|143001862|SUPERIORITY_OR_OTHER|||||||0.408|||||||ANCOVA|GLM model with baseline as a covariate||||||0.408
71745503|NCT00657046|143001863|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|GLM model with baseline as a covariate||||||0.004
71745504|NCT00657046|143001863|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|GLM model with baseline as a covariate||||||0.030
71745505|NCT00657046|143001864|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|GLM model with baseline as a covariate||||||0.025
71745506|NCT00657046|143001864|SUPERIORITY_OR_OTHER|||||||0.022|||||||ANCOVA|GLM model with baseline as a covariate.||||||0.022
71745507|NCT00657046|143001865|SUPERIORITY_OR_OTHER|||||||0.082|||||||Fisher Exact|||||||0.082
71745508|NCT00657046|143001865|SUPERIORITY_OR_OTHER|||||||0.008|||||||Fisher Exact|||||||0.008
71745509|NCT00890825|143001938|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2069|TWO_SIDED|80.0|0.56|1.14||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.|Regression, Cox|Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status|A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel|||1.14|0.56|0.2069
71745510|NCT00890825|143001939|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0138|TWO_SIDED|80.0|0.42|0.79||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Regression, Cox|The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.|A Hazard Ratio (HR) \< 1 favoured AZD6244 + Docetaxel|||0.79|0.42|0.0138
71745511|NCT00890825|143001940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|37.2|||<|0.0001|TWO_SIDED|95.0|23.0|53.0||Two-sided P-value|Fisher Exact|||||53|23|< 0.0001
71745512|NCT00890825|143001942|SUPERIORITY_OR_OTHER||LSmeans difference|-17.03||||0.004|TWO_SIDED|80.0|-25.2|-8.86||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-8.86|-25.2|0.004
71665751|NCT01272037|142845856|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.002|TWO_SIDED|95.0|0.43|0.83|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only premenopausal participants.||0.83|0.43|0.002
71665752|NCT01272037|142845856|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.89|TWO_SIDED|95.0|0.82|1.26|||Regression, Cox||To compare the Chemo and Endocrine Therapy arm to the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.26|0.82|0.89
71665753|NCT01272037|142845863|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.009|TWO_SIDED|95.0|0.39|0.87|||Regression, Cox|||This analysis includes only premenopausal participants.|To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|0.87|0.39|0.009
71665754|NCT01272037|142845863|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.81|1.37|||Regression, Cox||To compare DRFS between the Chemo and Endocrine Therapy arm and the Endocrine Therapy Alone arm, a Cox model was used with adjustment for the continuous recurrence score.|This analysis includes only postmenopausal participants.||1.37|0.81|0.70
71665755|NCT00113763|142845926|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||<0.0001
71665756|NCT00113763|142845927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.806||||||This analysis was conducted contingent on a statistically significant difference in the primary outcome, and adjusted to an a priori threshold for statistical significance at a 4% level for a multiple comparison involving objective tumor response|Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups||||0.806
71745513|NCT00890825|143001943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0||||0.004|TWO_SIDED|80.0|-38.34|-13.7||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)|||-13.7|-38.34|0.004
71745514|NCT00890825|143001944|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0158|TWO_SIDED|80.0|0.37|0.78||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Log Rank|Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate|A hazard ratio (HR) \<1 favours AZD6244 75 mg bd+Docetaxel|||0.78|0.37|0.0158
71745515|NCT02552966|143001967|OTHER|||||||0.61|||||||t-test, 2 sided|This t-test was applied to determine if the mean salivary pepsin concentration changed between baseline and 2 week post UESAD measurements.||||||0.61
71745516|NCT02552966|143001968|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71745517|NCT02552966|143001969|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71745518|NCT02552966|143001970|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71891008|NCT03068715|143304061|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.546|||||||t-test, 2 sided|Paired t-test was used for the statistics.||Functional connectivity between lDMN\_rDMN in participants receiving active iTBS.||||=0.546
71665757|NCT04933383|142845948|SUPERIORITY||difference/ratio of least square means|180.6||||0.000813|TWO_SIDED|95.0|106.42|306.48|||ANCOVA|||"The primary efficacy endpoint is the change from baseline in PC20 after each treatment period (baseline is defined at Visit 1).~For primary efficacy analysis, the mean PC20 changes from baseline between AQ001S and the comparator were compared by analysis of covariance (ANCOVA) for crossover design. A p-value was calculated for the difference of the parameter between AQ001S and the comparator.~Additionally, an adjusted 95%-CI for the mean difference was obtained by the ANCOVA."||306.48|106.42|0.000813
71665758|NCT00180661|142845950|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71665759|NCT00180661|142845951|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71665760|NCT02129608|142845962|SUPERIORITY_OR_OTHER|||||||0.398|||||||t-test, 2 sided|||||||0.398
71665761|NCT02129608|142845962|SUPERIORITY_OR_OTHER|||||||0.436|||||||t-test, 2 sided|||||||0.436
71665762|NCT02129608|142845963|SUPERIORITY_OR_OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.070
71665763|NCT02129608|142845963|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.950
71665764|NCT00451204|142845964|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.077|TWO_SIDED|95.0|0.37|1.05|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 mo, time since dx, previous glatiramer acetate tx, and previous interferon beta tx.||||1.05|0.37|0.077
71665765|NCT00451204|142845965|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.098|TWO_SIDED|95.0|0.39|1.08|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.08|0.39|0.098
71665766|NCT00451204|142845966|SUPERIORITY_OR_OTHER||Rate ratio|0.63||||0.096|TWO_SIDED|95.0|0.36|1.09|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.09|0.36|0.096
71745519|NCT00614380|143001978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||||95.0|0.22|0.53|||Cochran-Mantel-Haenszel|||||0.53|0.22|
71745520|NCT00614380|143001978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31||||||95.0|0.12|0.81|||Cochran-Mantel-Haenszel|||||0.81|0.12|
71745521|NCT00614380|143001978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||||95.0|0.06|0.13|||Cochran-Mantel-Haenszel|||||0.13|0.06|
71745522|NCT00614380|143001978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||||95.0|0.34|2.41|||Cochran-Mantel-Haenszel|||||2.41|0.34|
71745523|NCT00614380|143001978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||||95.0|0.16|0.39|||Cochran-Mantel-Haenszel|||||0.39|0.16|
71745524|NCT00614380|143001978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.1|0.72|||Cochran-Mantel-Haenszel|||||0.72|0.10|
71745525|NCT02365649|143001992|SUPERIORITY||Adjusted risk difference from placebo|9.9||||0.056|TWO_SIDED|95.0|-0.3|20.1||Statistical significance was prespecified at α = 0.1. Based on Cochran-Mantel-Haenszel (CMH) test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.1|-0.3|0.056
71665767|NCT00451204|142845967|SUPERIORITY_OR_OTHER||Rate ratio|0.7||||0.179|TWO_SIDED|95.0|0.42|1.17|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||1.17|0.42|0.179
71665768|NCT00451204|142845968|SUPERIORITY_OR_OTHER||Rate ratio|0.49||||0.016|TWO_SIDED|95.0|0.28|0.88|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.88|0.28|0.016
71665769|NCT00451204|142845969|SUPERIORITY_OR_OTHER||Rate ratio|0.52||||0.012|TWO_SIDED|95.0|0.31|0.86|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.||||0.86|0.31|0.012
71745526|NCT02365649|143001992|SUPERIORITY||Adjusted risk difference from placebo|7.4||||0.108|TWO_SIDED|95.0|-1.6|16.4||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.4|-1.6|0.108
71745527|NCT02365649|143001992|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
71745528|NCT02365649|143001992|SUPERIORITY||Adjusted risk difference from placebo|21.0||||0.004|TWO_SIDED|95.0|6.8|35.2||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.2|6.8|0.004
71779195|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-1.2|STANDARD_ERROR_OF_MEAN|0.72||0.1034|TWO_SIDED|95.0|-2.65|0.26|||ANCOVA|||Change at Week 12: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.26|-2.65|0.1034
71779196|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-1.91|STANDARD_ERROR_OF_MEAN|0.84||0.029|TWO_SIDED|95.0|-3.6|-0.21|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||-0.21|-3.60|0.0290
71779197|NCT02609828|143058372|SUPERIORITY||Difference in LS mean|-1.62|STANDARD_ERROR_OF_MEAN|0.83||0.06|TWO_SIDED|95.0|-3.31|0.07|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the non-index cancer pain sites and baseline opioid dose as covariates.||0.07|-3.31|0.0600
71779198|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8054|TWO_SIDED|95.0|0.41|3.18|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.18|0.41|0.8054
71834672|NCT05028582|143173878|SUPERIORITY|S-IGA Success Week 2|Odds Ratio (OR)|4.1|||<|0.0001|TWO_SIDED|97.5|1.84|9.13|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||9.13|1.84|<0.0001
71834673|NCT05028582|143173879|SUPERIORITY|S-IGA Success at Week 4|Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|97.5|2.62|8.84|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|Stratified by pooled study site, baseline S-IGA, and baseline B-IGA with multiple imputation to handle missing data|||8.84|2.62|<0.0001
71834674|NCT05028582|143173880|SUPERIORITY|Change from Baseline in PASI Week 2|LS Mean Difference|-1.28|||<|0.0001|TWO_SIDED|97.5|-1.71|-0.85|||ANCOVA|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|Covariate terms of treatment, pooled study site, baseline S-IGA, baseline B-IGA, and baseline PASI score \& multiple imputation to handle missing data|||-0.85|-1.71|<0.0001
71665770|NCT02652611|142845980|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.57|TWO_SIDED|95.0|-0.8|1.4|||t-test, 2 sided|||We reported the average pain and function from 6 to 24 months postinjury with 95% confidence intervals (CIs) and summarized pain and function at 6, 9, 12, 18, and 24 months postinjury with means and standard deviations and medians with interquartile ranges.||1.4|-0.8|=0.57
71665771|NCT02652611|142845981|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.21|TWO_SIDED|95.0|-2.9|12.3|||t-test, 2 sided|||||12.3|-2.9|0.21
71745529|NCT02365649|143001992|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.025|TWO_SIDED|95.0|1.8|25.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.5|1.8|0.025
71665772|NCT02237092|142845984|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71665773|NCT02237092|142845985|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71665774|NCT02237092|142845986|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||t-test, 2 sided|||||||<0.02
71665775|NCT02237092|142845987|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.58|||<|0.05|TWO_SIDED|95.0|1.05|2.58|||NNT|||||2.58|1.05|<0.05
71834675|NCT04402294|143173891|OTHER|Parametric inferential statistical test|Group mean difference|0.71||||0.5|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.50
71834676|NCT04402294|143173892|OTHER|Parametric inferential statistical test|Group mean difference|0.03||||0.975|TWO_SIDED|||||The threshold for statistical significance was set to p = 0.05|ANOVA|||ANOVA (Optimal vs Suboptimal vs No Stimulation)||||0.975
71834677|NCT04402294|143173893|OTHER|Parametric inferential statistical test|Group mean difference|2.05||||0.097|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.097
71745530|NCT02365649|143001993|SUPERIORITY||Adjusted risk difference from placebo|2.5||||0.74|TWO_SIDED|95.0|-12.3|17.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||17.3|-12.3|0.74
71745531|NCT02365649|143001993|SUPERIORITY||Adjusted risk difference from placebo|16.2||||0.082|TWO_SIDED|95.0|-2.0|34.3||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.3|-2.0|0.082
71745532|NCT02365649|143001993|SUPERIORITY||Adjusted risk difference from placebo|0.5||||0.952|TWO_SIDED|95.0|-14.1|15.0||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.0|-14.1|0.952
71745533|NCT02365649|143001993|SUPERIORITY||Adjusted risk difference from placebo|11.2||||0.205|TWO_SIDED|95.0|-6.1|28.5||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.5|-6.1|0.205
71745534|NCT02365649|143001993|SUPERIORITY||Adjusted risk difference from placebo|4.1||||0.607|TWO_SIDED|95.0|-11.5|19.6||Statistical significance was prespecified at α = 0.1. Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||19.6|-11.5|0.607
71745535|NCT02365649|143001994|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.564|TWO_SIDED|95.0|-12.5|22.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.9|-12.5|0.564
71745536|NCT02365649|143001994|SUPERIORITY||Adjusted risk difference from placebo|12.0||||0.221|TWO_SIDED|95.0|-7.2|31.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.2|-7.2|0.221
71745537|NCT02365649|143001994|SUPERIORITY||Adjusted risk difference from placebo|22.2||||0.036|TWO_SIDED|95.0|1.4|43.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43|1.4|0.036
71745538|NCT02365649|143001994|SUPERIORITY||Adjusted risk difference from placebo|13.4||||0.179|TWO_SIDED|95.0|-6.2|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.2|0.179
71745539|NCT02365649|143001994|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.677|TWO_SIDED|95.0|-14.3|22.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22|-14.3|0.677
71745540|NCT02365649|143001995|SUPERIORITY||Adjusted risk difference from placebo|10.4||||0.363|TWO_SIDED|95.0|-12.0|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-12|0.363
71745541|NCT02365649|143001995|SUPERIORITY||Adjusted risk difference from placebo|17.3||||0.137|TWO_SIDED|95.0|-5.5|40.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40|-5.5|0.137
71745542|NCT02365649|143001995|SUPERIORITY||Adjusted risk difference from placebo|7.5||||0.512|TWO_SIDED|95.0|-14.9|29.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.9|-14.9|0.512
71745543|NCT02365649|143001995|SUPERIORITY||Adjusted risk difference from placebo|25.0||||0.035|TWO_SIDED|95.0|-1.8|48.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.2|-1.8|0.035
71745544|NCT02365649|143001995|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.29|TWO_SIDED|95.0|-10.7|35.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||35.6|-10.7|0.29
71745545|NCT02365649|143001996|SUPERIORITY||Adjusted risk difference from placebo|-0.9||||0.896|TWO_SIDED|95.0|-15.0|13.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||13.1|-15.0|0.896
71745546|NCT02365649|143001996|SUPERIORITY||Adjusted risk difference from placebo|18.6||||0.05|TWO_SIDED|95.0|0.0|37.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.3|0.0|0.05
71745547|NCT02365649|143001996|SUPERIORITY||Adjusted risk difference from placebo|3.0||||0.702|TWO_SIDED|95.0|-12.4|18.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||18.4|-12.4|0.702
71745548|NCT02365649|143001996|SUPERIORITY||Adjusted risk difference from placebo|14.3||||0.117|TWO_SIDED|95.0|-3.6|32.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.2|-3.6|0.117
71745549|NCT02365649|143001996|SUPERIORITY||Adjusted risk difference from placebo|-2.4||||0.736|TWO_SIDED|95.0|-16.4|11.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||11.6|-16.4|0.736
71745550|NCT02365649|143001997|SUPERIORITY||Adjusted risk difference from placebo|2.9||||0.276|TWO_SIDED|95.0|-2.3|8.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.1|-2.3|0.276
71745551|NCT02365649|143001997|SUPERIORITY||Adjusted risk difference from placebo|4.9||||0.195|TWO_SIDED|95.0|-2.5|12.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.4|-2.5|0.195
71745552|NCT02365649|143001997|SUPERIORITY||Adjusted risk difference from placebo|2.6||||0.355|TWO_SIDED|95.0|-2.9|8.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||8.0|-2.9|0.355
71745553|NCT02365649|143001997|SUPERIORITY||Adjusted risk difference from placebo|7.7||||0.099|TWO_SIDED|95.0|-1.5|16.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||16.8|-1.5|0.099
71745554|NCT02365649|143001997|SUPERIORITY||Adjusted risk difference from placebo|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||12.9|-2.5|0.185
71745555|NCT02365649|143001998|SUPERIORITY||Adjusted risk difference from placebo|13.2||||0.05|TWO_SIDED|95.0|0.0|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|0.0|0.05
71745556|NCT02365649|143001998|SUPERIORITY||Adjusted risk difference from placebo|29.5||||0.001|TWO_SIDED|95.0|11.9|47.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||47.1|11.9|0.001
71745557|NCT02365649|143001998|SUPERIORITY||Adjusted risk difference from placebo|25.2||||0.003|TWO_SIDED|95.0|8.5|42.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||42.0|8.5|0.003
71779199|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9292|TWO_SIDED|95.0|0.22|3.98|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.98|0.22|0.9292
71779200|NCT02609828|143058375|SUPERIORITY|||||||0.9565|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9565
71779201|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.88||||0.1429|TWO_SIDED|95.0|0.81|4.36|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.36|0.81|0.1429
71779202|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|5.19||||0.014||95.0|1.4|19.31|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.31|1.40|0.0140
71779203|NCT02609828|143058375|SUPERIORITY|||||||0.945|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9450
71779204|NCT02609828|143058375|SUPERIORITY|||||||0.9489|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9489
71779205|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.63||||0.1932|TWO_SIDED|95.0|0.78|3.39|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.39|0.78|0.1932
71745558|NCT02365649|143001998|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|17.6|55.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||55.4|17.6|< 0.001
71745559|NCT02365649|143001998|SUPERIORITY||Adjusted risk difference from placebo|32.0|||<|0.001|TWO_SIDED|95.0|13.9|50.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.2|13.9|< 0.001
71745560|NCT02365649|143001999|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.243|TWO_SIDED|95.0|-7.2|28.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||28.2|-7.2|0.243
71745561|NCT02365649|143001999|SUPERIORITY||Adjusted risk difference from placebo|29.1||||0.006|TWO_SIDED|95.0|8.3|49.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.9|8.3|0.006
71745562|NCT02365649|143001999|SUPERIORITY||Adjusted risk difference from placebo|24.2||||0.017|TWO_SIDED|95.0|4.4|44.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||44.1|4.4|0.017
71745563|NCT02365649|143001999|SUPERIORITY||Adjusted risk difference from placebo|36.5|||<|0.001|TWO_SIDED|95.0|14.8|58.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.1|14.8|< 0.001
71745564|NCT02365649|143001999|SUPERIORITY||Adjusted risk difference from placebo|36.8|||<|0.001|TWO_SIDED|95.0|15.2|58.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.3|15.2|< 0.001
71745565|NCT02365649|143002000|SUPERIORITY||Adjusted risk difference from placebo|10.5||||0.353|TWO_SIDED|95.0|-11.7|32.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.7|-11.7|0.353
71745566|NCT02365649|143002000|SUPERIORITY||Adjusted risk difference from placebo|22.7||||0.05|TWO_SIDED|95.0|0.0|45.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||45.5|0.0|0.05
71745567|NCT02365649|143002000|SUPERIORITY||Adjusted risk difference from placebo|12.5||||0.268|TWO_SIDED|95.0|-9.6|34.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.6|-9.6|0.268
71745568|NCT02365649|143002000|SUPERIORITY||Adjusted risk difference from placebo|28.0||||0.018|TWO_SIDED|95.0|4.8|51.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||51.2|4.8|0.018
71745569|NCT02365649|143002000|SUPERIORITY||Adjusted risk difference from placebo|14.9||||0.204|TWO_SIDED|95.0|-8.1|37.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.8|-8.1|0.204
71745570|NCT02365649|143002001|SUPERIORITY||Adjusted risk difference from placebo|10.0||||0.421|TWO_SIDED|95.0|-14.4|34.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||34.4|-14.4|0.421
71745571|NCT02365649|143002001|SUPERIORITY||Adjusted risk difference from placebo|11.5||||0.371|TWO_SIDED|95.0|-13.8|36.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||36.8|-13.8|0.371
71745572|NCT02365649|143002001|SUPERIORITY||Adjusted risk difference from placebo|9.2||||0.445|TWO_SIDED|95.0|-14.4|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-14.4|0.445
71745573|NCT02365649|143002001|SUPERIORITY||Adjusted risk difference from placebo|19.5||||0.198|TWO_SIDED|95.0|-10.2|49.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.3|-10.2|0.198
71745574|NCT02365649|143002001|SUPERIORITY||Adjusted risk difference from placebo|5.0||||0.654|TWO_SIDED|95.0|-17.0|27.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||27.0|-17.0|0.654
71745575|NCT02365649|143002002|SUPERIORITY||Adjusted risk difference from placebo|18.7||||0.093|TWO_SIDED|95.0|-3.1|40.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.5|-3.1|0.093
71834678|NCT04402294|143173894|OTHER|Parametric Inferential Statistical Test|Group mean difference|0.63||||0.644|TWO_SIDED|||||The threshold for statistical significance was 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), stimulation days (1 to 3), and delay (0, 4, or 12 seconds) as within-subject variables.||||0.644
71665776|NCT00794339|142845993|EQUIVALENCE|equivalence margin=0||||||0.4883|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the the median survival was compared between the 2 groups.||||0.4883
71745576|NCT02365649|143002002|SUPERIORITY||Adjusted risk difference from placebo|13.5||||0.176|TWO_SIDED|95.0|-6.1|33.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.1|-6.1|0.176
71745577|NCT02365649|143002002|SUPERIORITY||Adjusted risk difference from placebo|35.9||||0.017|TWO_SIDED|95.0|6.3|65.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||65.5|6.3|0.017
71745578|NCT02365649|143002002|SUPERIORITY||Adjusted risk difference from placebo|26.1||||0.044|TWO_SIDED|95.0|0.7|51.5|||Cochran-Mantel-Haenszel|||||51.5|0.7|0.044
71745579|NCT02365649|143002002|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
71745580|NCT02365649|143002003|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.564|TWO_SIDED|95.0|-8.1|14.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||14.9|-8.1|0.564
71745581|NCT02365649|143002003|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
71745582|NCT02365649|143002003|SUPERIORITY||Adjusted risk difference from placebo|8.7||||0.326|TWO_SIDED|95.0|-8.7|26.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.1|-8.7|0.326
71745583|NCT02365649|143002004|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.195|TWO_SIDED|95.0|-6.2|30.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||30.7|-6.2|0.195
71745584|NCT02365649|143002004|SUPERIORITY||Adjusted risk difference from placebo|17.9||||0.116|TWO_SIDED|95.0|-4.4|40.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||40.1|-4.4|0.116
71745585|NCT02365649|143002004|SUPERIORITY||Adjusted risk difference from placebo|12.8||||0.178|TWO_SIDED|95.0|-5.8|31.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||31.5|-5.8|0.178
71745586|NCT02365649|143002004|SUPERIORITY||Adjusted risk difference from placebo|30.4||||0.031|TWO_SIDED|95.0|2.8|58.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||58.0|2.8|0.031
71745587|NCT02365649|143002004|SUPERIORITY||Adjusted risk difference from placebo|13.1||||0.121|TWO_SIDED|95.0|-3.5|29.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.6|-3.5|0.121
71745588|NCT02365649|143002005|SUPERIORITY||Adjusted risk difference from placebo|6.8||||0.392|TWO_SIDED|95.0|-8.7|22.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.2|-8.7|0.392
71745589|NCT02365649|143002005|SUPERIORITY||Adjusted risk difference from placebo|3.4||||0.584|TWO_SIDED|95.0|-8.8|15.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||15.7|-8.8|0.584
71745590|NCT02365649|143002005|SUPERIORITY||Adjusted risk difference from placebo|13.0||||0.199|TWO_SIDED|95.0|-6.8|32.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.9|-6.8|0.199
71745591|NCT02365649|143002005|SUPERIORITY||Adjusted risk difference from placebo|6.9||||0.439|TWO_SIDED|95.0|-10.6|24.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||24.5|-10.6|0.439
71745592|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-103.9||||0.788|TWO_SIDED|95.0|-865.69|657.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||657.87|-865.69|0.788
71745593|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-364.3||||0.325|TWO_SIDED|95.0|-1092.83|364.29||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||364.29|-1092.83|0.325
71745594|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-926.2||||0.015|TWO_SIDED|95.0|-1672.78|-179.63||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-179.63|-1672.78|0.015
71745595|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-763.1||||0.053|TWO_SIDED|95.0|-1534.52|8.39||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||8.39|-1534.52|0.053
71745596|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-359.5||||0.352|TWO_SIDED|95.0|-1119.52|400.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 4||400.56|-1119.52|0.352
71745597|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-396.2||||0.503|TWO_SIDED|95.0|-1565.39|772.9||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||772.90|-1565.39|0.503
71745598|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-364.3||||0.537|TWO_SIDED|95.0|-1531.04|802.44||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||802.44|-1531.04|0.537
71834679|NCT04402294|143173895|OTHER|Parametric inferential statistical test|Group mean difference|0.84||||0.439|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||ANOVA, with neuromodulation stimulation type (optimal vs. suboptimal), and stimulation days (1 to 3) as within-subject variables.||||0.439
71665777|NCT00794339|142845994|EQUIVALENCE|no equivalence margin|Slope|-0.1235|STANDARD_ERROR_OF_MEAN|1.6988||0.1924|TWO_SIDED||||||Regression, Logistic|||Logistic Regression Modeling Complete Metabolic Response by T/M Ratio||||0.1924
71891009|NCT03068715|143304061|SUPERIORITY|"FC was calculated as the correlation (Pearson) of the activity pattern across time between ROIs. All Pearson correlation coefficients were then transformed into Fisher's Z score for further analysis.~sgACC (BA25) was defined by Brodmann areas (BA). The 4 nodes of DMN were extracted from the Multi-Subject Dictionary Learning (MSDL) atlas."|||||=|0.607|||||||t-test, 2 sided|||Functional connectivity between lDMN\_rDMN in participants receiving sham iTBS.||||=0.607
71745599|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-483.2||||0.425|TWO_SIDED|95.0|-1677.87|711.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||711.52|-1677.87|0.425
71745600|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-1025.6||||0.134|TWO_SIDED|95.0|-2373.24|322.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||322.08|-2373.24|0.134
71745601|NCT02365649|143002006|SUPERIORITY||LS Mean Difference|-637.9||||0.293|TWO_SIDED|95.0|-1833.82|557.96||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||557.96|-1833.82|0.293
71745602|NCT02365649|143002007|SUPERIORITY||LS Mean Difference|0.5||||0.921|TWO_SIDED|95.0|-9.02|9.97||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||9.97|-9.02|0.921
71745603|NCT02365649|143002007|SUPERIORITY||LS Mean Difference|-1.6||||0.75|TWO_SIDED|95.0|-11.19|8.08||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.08|-11.19|0.75
71745604|NCT02365649|143002007|SUPERIORITY||LS Mean Difference|-1.9||||0.7|TWO_SIDED|95.0|-11.7|7.87||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||7.87|-11.7|0.7
71891010|NCT03068715|143304062|SUPERIORITY||P value of the interaction|0.11|||<|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons at this time.|Mixed Models Analysis|We were interested in the interaction between treatment condition and timepoint.||We conducted a linear mixed models analysis, with a focus on the interaction term. No power analysis for this measure because number of participants was determined by other primary study aims.||||<0.05
71891011|NCT03068715|143304063|SUPERIORITY|The SDNN (the standard deviation of the RR intervals) was recorded using ECG. It was not necessary to conduct a power analysis for this measure because the number of participants in the study was based on other considerations (primary treatment goals of the study).|P value of the interaction|0.245|||<|0.05|TWO_SIDED|||||For reporting purposes here the p value was not adjusted for multiple comparisons.|Mixed Models Analysis|We were interested in the significance of the interaction between treatment group and timepoint.||We used a linear mixed models analysis, with the fixed factors being treatment group and timepoint.||||<0.05
71891012|NCT01276288|143304083|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.08|STANDARD_DEVIATION|11.8||0.0092|TWO_SIDED|90.0|97.11|118.07||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||118.07|97.11|0.0092
71665778|NCT00794339|142845995|EQUIVALENCE|equivalence margin = 0||||||0.309|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups: those at or above the median for T/M Ratio (7.3) vs. those below, and the time to primary tumor recurrence was compared between the 2 goups.||||0.3090
71745605|NCT02365649|143002007|SUPERIORITY||LS Mean Difference|-11.4||||0.024|TWO_SIDED|95.0|-21.38|-1.51||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-1.51|-21.38|0.024
71745606|NCT02365649|143002007|SUPERIORITY||LS Mean Difference|-1.0||||0.845|TWO_SIDED|95.0|-10.72|8.79||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||8.79|-10.72|0.845
71745607|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|1.7||||0.83|TWO_SIDED|95.0|-13.6|16.92||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||16.92|-13.60|0.830
71745608|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|17.5||||0.027|TWO_SIDED|95.0|2.03|33.0||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||33.00|2.03|0.027
71745609|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|8.9||||0.263|TWO_SIDED|95.0|-6.72|24.47||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.47|-6.72|0.263
71745610|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|21.6||||0.008|TWO_SIDED|95.0|5.68|37.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||37.52|5.68|0.008
71891013|NCT01276288|143304083|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.83|STANDARD_DEVIATION|8.9||0.003|TWO_SIDED|90.0|100.14|116.11||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.11|100.14|0.0030
71891014|NCT01276288|143304084|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.78|STANDARD_DEVIATION|18.3||0.0199|TWO_SIDED|90.0|88.55|119.29||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||119.29|88.55|0.0199
71891015|NCT01276288|143304084|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|107.5|STANDARD_DEVIATION|11.3||0.0086|TWO_SIDED|90.0|97.9|118.04||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||118.04|97.90|0.0086
71891016|NCT01276288|143304085|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|96.27|STANDARD_DEVIATION|9.6||0.0008|TWO_SIDED|90.0|89.08|104.05||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||104.05|89.08|0.0008
71891017|NCT01276288|143304086|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.77|STANDARD_DEVIATION|17.1||0.0114|TWO_SIDED|90.0|88.63|116.85||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included||116.85|88.63|0.0114
71891018|NCT01276288|143304087|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|101.44|STANDARD_DEVIATION|2.9|<|0.0001|TWO_SIDED|90.0|99.06|103.88||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||103.88|99.06|<0.0001
71745611|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|8.8||||0.269|TWO_SIDED|95.0|-6.88|24.53||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 8||24.53|-6.88|0.269
71745612|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|10.3||||0.231|TWO_SIDED|95.0|-6.63|27.25||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||27.25|-6.63|0.231
71665779|NCT00794339|142845996|EQUIVALENCE|equivalence margin=0||||||0.5291|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake ratio as a Predictor of PELVIC Lymph Node Metastases at Baseline||||0.5291
71745613|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|27.9||||0.002|TWO_SIDED|95.0|10.68|45.15||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||45.15|10.68|0.002
71745614|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|17.1||||0.057|TWO_SIDED|95.0|-0.51|34.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||34.72|-0.51|0.057
71745615|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|28.8||||0.002|TWO_SIDED|95.0|11.12|46.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||Week 16||46.56|11.12|0.002
71745616|NCT02365649|143002008|SUPERIORITY||LS Mean Difference|12.3||||0.165|TWO_SIDED|95.0|-5.12|29.72||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||29.72|-5.12|0.165
71745617|NCT02365649|143002009|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
71745618|NCT02365649|143002009|SUPERIORITY||Adjusted risk difference from placebo|16.7||||0.221|TWO_SIDED|95.0|-10.0|43.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||43.3|-10.0|0.221
71745619|NCT02365649|143002009|SUPERIORITY||Adjusted risk difference from placebo|20.0||||0.18|TWO_SIDED|95.0|-9.2|49.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||49.2|-9.2|0.18
71745620|NCT02365649|143002009|SUPERIORITY||LS Mean Difference|20.0||||0.167|TWO_SIDED|95.0|-8.4|48.4||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||48.4|-8.4|0.167
71745621|NCT02365649|143002010|SUPERIORITY||Adjusted risk difference from placebo|5.5||||0.607|TWO_SIDED|95.0|-15.5|26.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||26.5|-15.5|0.607
71745622|NCT02365649|143002010|SUPERIORITY||Adjusted risk difference from placebo|12.2||||0.272|TWO_SIDED|95.0|-9.6|33.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||33.9|-9.6|0.272
71745623|NCT02365649|143002010|SUPERIORITY||Adjusted risk difference from placebo|15.9||||-0.157|TWO_SIDED|95.0|-6.1|37.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.9|-6.1|-0.157
71745624|NCT02365649|143002010|SUPERIORITY||LS Mean Difference|27.7||||0.017|TWO_SIDED|95.0|4.9|50.6||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.6|4.9|0.017
71745625|NCT02365649|143002010|SUPERIORITY||Adjusted risk difference from placebo|2.8||||0.798|TWO_SIDED|95.0|-18.4|23.9||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||23.9|-18.4|0.798
71745626|NCT02365649|143002011|SUPERIORITY||Adjusted risk difference from placebo|9.8||||0.119|TWO_SIDED|95.0|-2.5|22.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||22.1|-2.5|0.119
71745627|NCT02365649|143002011|SUPERIORITY||Adjusted risk difference from placebo|15.4||||0.034|TWO_SIDED|95.0|1.1|29.7||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||29.7|1.1|0.034
71745628|NCT02365649|143002011|SUPERIORITY||Adjusted risk difference from placebo|23.2||||0.004|TWO_SIDED|95.0|7.3|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|7.3|0.004
71745629|NCT02365649|143002011|SUPERIORITY||Adjusted risk difference from placebo|32.4|||<|0.001|TWO_SIDED|95.0|14.2|50.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||50.5|14.2|< 0.001
71745630|NCT02365649|143002011|SUPERIORITY||Adjusted risk difference from placebo|22.9|||<|0.006|TWO_SIDED|95.0|6.6|39.2||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||39.2|6.6|< 0.006
71745631|NCT02365649|143002012|SUPERIORITY||Adjusted risk difference from placebo|3.9||||0.647|TWO_SIDED|95.0|-12.7|20.5||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||20.5|-12.7|0.647
71745632|NCT02365649|143002012|SUPERIORITY||Adjusted risk difference from placebo|17.1||||0.093|TWO_SIDED|95.0|-2.9|37.1||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||37.1|-2.9|0.093
71745633|NCT02365649|143002012|SUPERIORITY||Adjusted risk difference from placebo|13.6||||0.165|TWO_SIDED|95.0|-5.6|32.8||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||32.8|-5.6|0.165
71745634|NCT02365649|143002012|SUPERIORITY||Adjusted risk difference from placebo|24.9||||0.023|TWO_SIDED|95.0|3.4|46.3||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||46.3|3.4|0.023
71745635|NCT02365649|143002012|SUPERIORITY||Adjusted risk difference from placebo|7.0||||0.448|TWO_SIDED|95.0|-11.0|25.0||Based on CMH test stratified by baseline SES-CD (SES-CD \<15 and SES-CD \>=15).|Cochran-Mantel-Haenszel|||||25.0|-11.0|0.448
71745636|NCT02365649|143002013|SUPERIORITY||LS Mean Difference|0.4||||0.412|TWO_SIDED|95.0|-0.62|1.5||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.5|-0.62|0.412
71779206|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0254|TWO_SIDED|95.0|1.15|8.74|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.74|1.15|0.0254
71779207|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0455|TWO_SIDED|95.0|1.03|24.16|||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||24.16|1.03|0.0455
71891019|NCT01276288|143304087|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.42|STANDARD_DEVIATION|4.8|<|0.0001|TWO_SIDED|90.0|100.39|108.62||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||108.62|100.39|<0.0001
71891020|NCT01276288|143304087|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|103.19|STANDARD_DEVIATION|8.9||0.0005|TWO_SIDED|90.0|95.93|111.01||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.01|95.93|0.0005
71745637|NCT02365649|143002013|SUPERIORITY||LS Mean Difference|-1.4||||0.01|TWO_SIDED|95.0|-2.47|-0.34||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.34|-2.47|0.01
71891021|NCT01276288|143304088|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|104.43|STANDARD_DEVIATION|13.1||0.0066|TWO_SIDED|90.0|93.81|116.25||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||116.25|93.81|0.0066
71745638|NCT02365649|143002013|SUPERIORITY||LS Mean Difference|-1.0||||0.082|TWO_SIDED|95.0|-2.13|0.13||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.13|-2.13|0.082
71745639|NCT02365649|143002013|SUPERIORITY||LS Mean Difference|-1.6||||0.004|TWO_SIDED|95.0|-2.73|-0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.52|-2.73|0.004
71745640|NCT02365649|143002013|SUPERIORITY||LS Mean Difference|0.2||||0.766|TWO_SIDED|95.0|-0.93|1.26||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||1.26|-0.93|0.766
71665780|NCT00794339|142845996|EQUIVALENCE|equivalence margin=0||||||0.9684|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of COMMON ILIAC Lymph Node Metastases at Baseline||||0.9684
71665781|NCT00794339|142845996|EQUIVALENCE|equivalence margin=0||||||0.7327|||||||Regression, Logistic|||Logistic Regression Evaluating Tissue to Muscle (T/M) uptake Ratio as a Predictor of Para Aortic Lymph Node Metastases at Baseline||||0.7327
71665782|NCT00794339|142846006|EQUIVALENCE|equivalence margin=0||||||0.4981|||||||Wilcoxon (Mann-Whitney)|||Participants were divided into two groups by whether their T/M Ratio fell at or above vs. below the observed median of 7.3 and the time to observe new distant metastases was compared between the groups||||.4981
71745641|NCT02365649|143002014|SUPERIORITY||LS Mean Difference|-0.6||||0.314|TWO_SIDED|95.0|-1.75|0.56||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.56|-1.75|0.314
71745642|NCT02365649|143002014|SUPERIORITY||LS Mean Difference|-1.8||||0.002|TWO_SIDED|95.0|-3.01|-0.68||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.68|-3.01|0.002
71745643|NCT02365649|143002014|SUPERIORITY||LS Mean Difference|-0.7||||0.255|TWO_SIDED|95.0|-1.94|0.52||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.52|-1.94|0.255
71745644|NCT02365649|143002014|SUPERIORITY||LS Mean Difference|-1.4||||0.022|TWO_SIDED|95.0|-2.61|-0.2||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||-0.2|-2.61|0.022
71779208|NCT02609828|143058375|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
71891022|NCT01276288|143304088|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.67|STANDARD_DEVIATION|10.6||0.0012|TWO_SIDED|90.0|94.13|111.97||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||111.97|94.13|0.0012
71891023|NCT01276288|143304088|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing in a confirmatory sense|Geometric mean ratio|102.42|STANDARD_DEVIATION|5.8|<|0.0001|TWO_SIDED|90.0|97.65|107.42||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included||107.42|97.65|<0.0001
71891024|NCT02537678|143304091|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.43||0.006|ONE_SIDED|97.5|-3.26||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.26|.006
71891025|NCT02537678|143304092|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|1.49||0.004|ONE_SIDED|97.5|-3.47||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 SD units.|Treatment difference = standard Trauma Focused -CBT - stepped care Trauma Focused-CBT||-3.47|.004
71665783|NCT01807065|142846034|OTHER|||||||0.06|||||||Log Rank|||||||0.06
71891026|NCT02537678|143304093|NON_INFERIORITY|We planned 0.41standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied 12-month assessment.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.2||0.001|ONE_SIDED|97.5|-2.5||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.50|.001
71665784|NCT02054338|142846053|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.54|TWO_SIDED|95.0|0.91|1.2|||Log Rank|||Kaplan-Meier curves and life tables by treatment arm to describe time-dependent parameters. Stratified Cox proportional model was used to compare the 2 treatment arms. A stratified Cox proportional hazards model and logistic regression were applied to the progression-free survival and to the tumour response, respectively.||1.20|0.91|0.54
71665785|NCT02054338|142846054|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.87|1.19|||Log Rank|||||1.19|0.87|0.86
71665786|NCT02054338|142846055|SUPERIORITY||Hazard Ratio (HR)|11.3||||0.1|TWO_SIDED|95.0|8.7|14.4|||Log Rank|||||14.4|8.7|0.10
71665787|NCT00396565|142846081|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001||95.0|-17.16|-8.25|||ANCOVA|ANCOVA model with treatment as a factor and baseline score as a covariate||||-8.25|-17.16|<0.0001
71665788|NCT00396565|142846082|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001||95.0|-5.17|-2.51|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate.||||-2.51|-5.17|<0.0001
71665789|NCT00396565|142846083|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.71|-1.33|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate||||-1.33|-3.71|<0.0001
71665790|NCT00396565|142846084|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001||95.0|-8.58|-3.8|||ANCOVA|ANCOVA model with treatment as a factor, and with baseline score as a covariate||||-3.80|-8.58|<0.0001
71665791|NCT00396565|142846085|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Fisher Exact|||||||0.0007
71665792|NCT00396565|142846086|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.84|-0.34|||ANCOVA|ANCOVA model with treatment as a factor, and baseline score as a covariate||||-0.34|-0.84|<0.0001
71665793|NCT01252277|142846095|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71665794|NCT01252277|142846096|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.021
71665795|NCT01252277|142846097|SUPERIORITY_OR_OTHER||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71665796|NCT01252277|142846098|SUPERIORITY_OR_OTHER|||||||0.48||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.48
71665797|NCT03097991|142846131|SUPERIORITY||Slope|1.86|STANDARD_ERROR_OF_MEAN|1.86||0.32|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.32
71665798|NCT03097991|142846131|SUPERIORITY||Slope|-0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.53
71665799|NCT03097991|142846132|SUPERIORITY||Slope|-3.04|STANDARD_ERROR_OF_MEAN|1.63||0.07|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.07
71665800|NCT03097991|142846132|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||||Group Effect|||.69
71665801|NCT03097991|142846133|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|2.0||0.22|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.22
71665802|NCT03097991|142846133|SUPERIORITY||Slope|0.84|STANDARD_ERROR_OF_MEAN|1.33||0.53|TWO_SIDED||||||Mixed Models Analysis||Group effect|||||.53
71665803|NCT03097991|142846134|SUPERIORITY||Slope|-1.73|STANDARD_ERROR_OF_MEAN|1.76||0.33|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.33
71665804|NCT03097991|142846134|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.36||0.69|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.69
71665805|NCT03097991|142846135|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
71665806|NCT03097991|142846135|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
71665807|NCT03097991|142846136|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
71665808|NCT03097991|142846136|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.85
71665809|NCT03097991|142846137|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.56|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint Effect|||||.56
71665810|NCT03097991|142846137|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.81|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.81
71665811|NCT03097991|142846138|SUPERIORITY||Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint effect|||||.85
71665812|NCT03097991|142846138|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.77|TWO_SIDED||||||Mixed Models Analysis||Group Effect|||||.77
71665813|NCT03097991|142846139|SUPERIORITY||Slope|21.01|STANDARD_ERROR_OF_MEAN|5.91|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.001
71665814|NCT03097991|142846139|SUPERIORITY||Slope|2.98|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
71665815|NCT03097991|142846140|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|linear mixed effects|Group|||||<.05
71665816|NCT03097991|142846140|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||<.05
71665817|NCT03097991|142846141|SUPERIORITY||Slope|3.52|STANDARD_ERROR_OF_MEAN|4.14||0.39|TWO_SIDED||||||Mixed Models Analysis||Group|"We analyzed the CTS scales Psychological Aggression and Physical Assault. Inspection of the latter in the raw data and descriptives showed extremely consistent selection of the lowest value of the scale (no incidents of assault) across all respondents, so we did not conduct inferential tests."||||.39
71665818|NCT03097991|142846141|SUPERIORITY||Slope|-13.38|STANDARD_ERROR_OF_MEAN|4.86|<|0.005|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||<.005
71665819|NCT03097991|142846142|SUPERIORITY||Slope|-1.17|STANDARD_ERROR_OF_MEAN|1.25||0.24|TWO_SIDED||||||Mixed Models Analysis||Group|||||.24
71665820|NCT03097991|142846142|EQUIVALENCE|ANOVA found a main effect of group, F(1, 155) = 6.85, p \< .05, η2G = .04.|Mean Difference (Final Values)|6.85|||<|0.05|TWO_SIDED||||||ANOVA||Group|||||<.05
71665821|NCT03097991|142846143|SUPERIORITY||Slope|-2.53|STANDARD_ERROR_OF_MEAN|1.04||0.02|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.02
71665822|NCT03097991|142846143|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED||||||Mixed Models Analysis||Group|||||.56
71665823|NCT03097991|142846144|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.30
71665824|NCT03097991|142846144|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.67||0.36|TWO_SIDED||||||Mixed Models Analysis||Group|||||.36
71665825|NCT03097991|142846145|SUPERIORITY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.55||0.17|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.17
71665826|NCT03097991|142846145|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
71665827|NCT03097991|142846146|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|7.34||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
71665828|NCT03097991|142846146|SUPERIORITY||Slope|7.94|STANDARD_ERROR_OF_MEAN|9.0||0.38|TWO_SIDED||||||Mixed Models Analysis||Group x Time|||||.38
71665829|NCT03097991|142846147|SUPERIORITY||Slope|-1.89|STANDARD_ERROR_OF_MEAN|1.05||0.07|TWO_SIDED||||||Mixed Models Analysis||Parent x Group|||||.07
71834680|NCT04402294|143173896|OTHER|Parametric inferential statistical test|Group mean difference|0.59||||0.563|TWO_SIDED|||||The threshold for statistical significance was p = 0.05|ANOVA|||Optimal Neuromodulation Day-1, Optimal Neuromodulation Day-2, Optimal Neuromodulation Day-3, Suboptimal Neuromodulation Day-1, Suboptimal Neuromodulation Day-2, Suboptimal Neuromodulation Day-3||||0.563
71665830|NCT03097991|142846147|SUPERIORITY||Slope|2.52|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Group|||||<.001
71665831|NCT03097991|142846148|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.92|TWO_SIDED||||||Mixed Models Analysis||Group|||||.92
71665832|NCT03097991|142846148|SUPERIORITY||Slope|1.12|STANDARD_ERROR_OF_MEAN|0.57||0.05|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.05
71665833|NCT03097991|142846149|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.47||0.81|TWO_SIDED||||||Mixed Models Analysis||Group|||||.81
71665834|NCT03097991|142846149|SUPERIORITY||Slope|-0.67|STANDARD_ERROR_OF_MEAN|0.7||0.34|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.34
71665835|NCT03097991|142846150|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.33||0.76|TWO_SIDED||||||Mixed Models Analysis||Group|||||.76
71665836|NCT03097991|142846150|SUPERIORITY||Slope|0.31|STANDARD_ERROR_OF_MEAN|0.49||0.53|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.53
71665837|NCT03097991|142846151|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16||0.88|TWO_SIDED||||||Mixed Models Analysis||Group|||||.88
71665838|NCT03097991|142846151|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.95
71834681|NCT03481660|143173897|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|-0.6|3.1|||ANOVA|||BCVA at Week 52||3.1|-0.6|<0.001
71834682|NCT03481660|143173898|NON_INFERIORITY|(4-letter margin) (1-sided)|LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-0.9|2.6|||ANOVA|||BCVA over period Week 40 through Week 52||2.6|-0.9|<0.001
71834683|NCT03481660|143173898|SUPERIORITY|||||||0.164|||||||ANOVA|||BCVA over period Week 40 through Week 52||||0.164
71665839|NCT03097991|142846152|SUPERIORITY||Slope|0.82|STANDARD_ERROR_OF_MEAN|1.13||0.47|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.47
71665840|NCT03097991|142846152|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
71665841|NCT03097991|142846153|SUPERIORITY||Slope|0.54|STANDARD_ERROR_OF_MEAN|1.32||0.68|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.68
71665842|NCT03097991|142846153|SUPERIORITY||Slope|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.07|TWO_SIDED||||||Mixed Models Analysis||Group|||||.07
71665843|NCT03097991|142846154|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|1.9||0.65|TWO_SIDED||||||Mixed Models Analysis||Group|||||.65
71665844|NCT03097991|142846154|SUPERIORITY||Slope|-1.65|STANDARD_ERROR_OF_MEAN|2.44||0.5|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.50
71665845|NCT03097991|142846155|SUPERIORITY||Slope|0.92|STANDARD_ERROR_OF_MEAN|1.3||0.48|TWO_SIDED||||||Mixed Models Analysis||Group|||||.48
71665846|NCT03097991|142846155|SUPERIORITY||Slope|-1.92|STANDARD_ERROR_OF_MEAN|1.72||0.27|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.27
71665847|NCT03097991|142846156|SUPERIORITY||Slope|-1.15|STANDARD_ERROR_OF_MEAN|1.22||0.01|TWO_SIDED||||||Mixed Models Analysis||Group|||||.01
71665848|NCT03097991|142846156|SUPERIORITY||Slope|1.08|STANDARD_ERROR_OF_MEAN|1.96||0.58|TWO_SIDED||||||Mixed Models Analysis||Group x Timepoint|||||.58
71665849|NCT02006732|142846159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.261|0.336|||Mixed Effects Model for Repeated Measure|||||0.336|0.261|<0.0001
71665850|NCT02006732|142846159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.069|0.141|||Mixed Effects Model for Repeated Measure|||||0.141|0.069|<0.0001
71665851|NCT02006732|142846159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.246|0.323|||Mixed Effects Model for Repeated Measure|||||0.323|0.246|<0.0001
71665852|NCT02006732|142846159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||Mixed Effects Model for Repeated Measure|||||0.128|0.053|<0.0001
71665853|NCT02006732|142846159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.156|0.232|||Mixed Effects Model for Repeated Measure|||||0.232|0.156|<0.0001
71665854|NCT02006732|142846159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.019||0.4499|TWO_SIDED|95.0|-0.023|0.051|||Mixed Effects Model for Repeated Measure|||||0.051|-0.023|0.4499
71665855|NCT02006732|142846160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.129|0.203|||Mixed Effects Model for Repeated Measure|||||0.203|0.129|<0.0001
71665856|NCT02006732|142846160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.019||0.0395|TWO_SIDED|95.0|0.002|0.076|||Mixed Effects Model for Repeated Measure|||||0.076|0.002|0.0395
71665857|NCT02006732|142846160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.132|0.207|||Mixed Effects Model for Repeated Measure|||||0.207|0.132|<0.0001
71665858|NCT02006732|142846160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.019||0.0269|TWO_SIDED|95.0|0.005|0.079|||Mixed Effects Model for Repeated Measure|||||0.079|0.005|0.0269
71665859|NCT02006732|142846160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.09|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.090|<0.0001
71665860|NCT02006732|142846160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019||0.8669|TWO_SIDED|95.0|-0.04|0.034|||Mixed Effects Model for Repeated Measure|||||0.034|-0.040|0.8669
71665861|NCT02006732|142846161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.564|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|-6.499|-2.629|||Mixed Effects Model for Repeated Measure|||||-2.629|-6.499|<0.0001
71665862|NCT02006732|142846161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.974||0.078|TWO_SIDED|95.0|-3.628|0.193|||Mixed Effects Model for Repeated Measure|||||0.193|-3.628|0.0780
71834684|NCT03481660|143173905|OTHER|Treatment Difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-0.6|3.1||||||BCVA at Week 52||3.1|-0.6|
71834685|NCT03481660|143173905|OTHER|Treatment Difference|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|1.21|||TWO_SIDED|95.0|0.2|4.9||||||BCVA at Week 100||4.9|0.2|
71779209|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0969|TWO_SIDED|95.0|0.9|3.72|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.72|0.90|0.0969
71779210|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0043|TWO_SIDED|95.0|1.58|11.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||11.74|1.58|0.0043
71779211|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|5.49||||0.0352|TWO_SIDED|95.0|1.13|26.75|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||26.75|1.13|0.0352
71779212|NCT02609828|143058375|SUPERIORITY|||||||0.9464|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9464
71779213|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1471|TWO_SIDED|95.0|0.83|3.52|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.52|0.83|0.1471
71779214|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0405|TWO_SIDED|95.0|1.04|6.22|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.22|1.04|0.0405
71779215|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0993|TWO_SIDED|95.0|0.8|12.83|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||12.83|0.80|0.0993
71779216|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1726|TWO_SIDED|95.0|0.51|43.64|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||43.64|0.51|0.1726
71779217|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0918|TWO_SIDED|95.0|0.91|3.74|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.74|0.91|0.0918
71779218|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0704|TWO_SIDED|95.0|0.94|4.82|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.82|0.94|0.0704
71834686|NCT03481660|143173906|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-0.6|2.1||||||BCVA over period Week 4 through Week 52||2.1|-0.6|
71834687|NCT03481660|143173906|OTHER|Treatment difference|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.4|2.6||||||BCVA over period Week 4 through Week 100||2.6|-0.4|
71665863|NCT02006732|142846161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.666|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.611|-1.721|||Mixed Effects Model for Repeated Measure|||||-1.721|-5.611|0.0002
71779219|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3569|TWO_SIDED|95.0|0.56|5.01|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.01|0.56|0.3569
71779220|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|2.46||||0.3062|TWO_SIDED|95.0|0.44|13.79|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.79|0.44|0.3062
71779221|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.84||||0.1058|TWO_SIDED|95.0|0.88|3.85|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.85|0.88|0.1058
71779222|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.81||||0.1571|TWO_SIDED|95.0|0.79|4.14|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.14|0.79|0.1571
71779223|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2454|TWO_SIDED|95.0|0.65|5.24|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.24|0.65|0.2454
71834688|NCT03481660|143173907|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-0.9|2.4||||||BCVA over period Week 20 through Week 52||2.4|-0.9|
71834689|NCT03481660|143173907|OTHER|Treatment difference|LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-0.9|2.5||||||BCVA over period Week 28 through Week 52||2.5|-0.9|
71834690|NCT03481660|143173907|OTHER|Treatment difference|LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-0.5|2.9||||||BCVA over period Week 20 through Week 100||2.9|-0.5|
71834691|NCT03481660|143173907|OTHER|Treatment difference|LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-0.5|3.0||||||BCVA over period Week 28 through Week 100||3.0|-0.5|
71834692|NCT03481660|143173908|OTHER|Treatment difference|LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-0.1|4.3||||||BCVA over period Week 88 through Week 100||4.3|-0.1|
71745645|NCT02365649|143002014|SUPERIORITY||LS Mean Difference|-0.7||||0.239|TWO_SIDED|95.0|-1.92|0.48||P value for test of difference using the repeated measure model including treatment, Baseline disease severity (SES-CD \< 15 and ≥ 15), week, Baseline, interaction of treatment and week.|mixed-effect model repeated measure|||||0.48|-1.92|0.239
71745646|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-36.4|21.4||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||21.4|-36.4|1.000
71745647|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-22.5|32.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||32.5|-22.5|1.000
71745648|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|-20.0||||0.272|TWO_SIDED|95.0|-37.5|-2.5||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||-2.5|-37.5|0.272
71745649|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-2.7|8.6||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||8.6|-2.7|1.000
71745650|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|13.0||||0.068|TWO_SIDED|95.0|-0.7|26.8||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||26.8|-0.7|0.068
71745651|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|-5.4||||1|TWO_SIDED|95.0|-23.1|12.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||12.3|-23.1|1.0000
71745652|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-15.7|18.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||18.3|-15.7|1.000
71745653|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-16.7|23.3||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||23.3|-16.7|1.000
71745654|NCT02365649|143002015|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders||13.9|-4.3|1.000
71745655|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-35.5|35.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||35.5|-35.5|1.000
71745656|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|12.5||||0.483|TWO_SIDED|95.0|-17.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||42.9|-17.9|0.483
71745657|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|-15.0||||0.633|TWO_SIDED|95.0|-41.6|11.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||11.6|-41.6|0.633
71745658|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|6.9||||0.424|TWO_SIDED|95.0|-12.7|26.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||26.4|-12.7|0.424
71745659|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
71834693|NCT03481660|143173909|OTHER|Treatment difference|Clopper-Pearson exact method|0.4|||||TWO_SIDED|95.0|-7.6|8.9||||||Gain of \>= 5 letters in BCVA at Week 52||8.9|-7.6|
71834694|NCT03481660|143173909|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.5||||||Gain of \>= 5 letters in BCVA at Week 100||14.5|-3.9|
71745660|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|14.3||||0.149|TWO_SIDED|95.0|-2.4|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.9|-2.4|0.149
71665864|NCT02006732|142846161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.979||0.4028|TWO_SIDED|95.0|-2.741|1.102|||Mixed Effects Model for Repeated Measure|||||1.102|-2.741|0.4028
71665865|NCT02006732|142846161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.993||0.0042|TWO_SIDED|95.0|-4.796|-0.897|||Mixed Effects Model for Repeated Measure|||||-0.897|-4.796|0.0042
71745661|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|5.8||||0.684|TWO_SIDED|95.0|-19.1|30.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||30.7|-19.1|0.684
71745662|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|8.5||||0.404|TWO_SIDED|95.0|-11.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.5|-11.5|0.404
71745663|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|10.7||||0.47|TWO_SIDED|95.0|-12.8|34.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.1|-12.8|0.470
71745664|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71779224|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8867|TWO_SIDED|95.0|0.24|3.46|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.46|0.24|0.8867
71745665|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
71745666|NCT02365649|143002016|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71745667|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|-16.9||||0.624|TWO_SIDED|95.0|-48.4|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||14.6|-48.4|0.624
71745668|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|3.9||||1|TWO_SIDED|95.0|-28.3|36.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||36.1|-28.3|1.000
71745669|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|-19.4||||0.363|TWO_SIDED|95.0|-48.0|9.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||9.1|-48.0|0.363
71745670|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|6.1||||0.495|TWO_SIDED|95.0|-2.1|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.2|-2.1|0.495
71745671|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|15.0||||0.066|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||30.6|-0.6|0.066
71779225|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0689|TWO_SIDED|95.0|0.95|4.21|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.21|0.95|0.0689
71665866|NCT02006732|142846161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.898|STANDARD_ERROR_OF_MEAN|0.971||0.3555|TWO_SIDED|95.0|-2.804|1.008|||Mixed Effects Model for Repeated Measure|||||1.008|-2.804|0.3555
71665867|NCT02006732|142846162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.668|STANDARD_ERROR_OF_MEAN|0.71|<|0.0001|TWO_SIDED|95.0|-6.06|-3.276|||Mixed Effects Model for Repeated Measure|||||-3.276|-6.060|<0.0001
71665868|NCT02006732|142846162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.097|STANDARD_ERROR_OF_MEAN|0.701||0.0028|TWO_SIDED|95.0|-3.471|-0.723|||Mixed Effects Model for Repeated Measure|||||-0.723|-3.471|0.0028
71745672|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|-10.7||||0.645|TWO_SIDED|95.0|-30.3|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||8.9|-30.3|0.645
71745673|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|4.4||||0.686|TWO_SIDED|95.0|-16.8|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||25.5|-16.8|0.686
71745674|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|4.4||||0.721|TWO_SIDED|95.0|-19.5|28.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.2|-19.5|0.721
71745675|NCT02365649|143002017|SUPERIORITY||Risk Difference (RD)|4.8||||1|TWO_SIDED|95.0|-4.3|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.9|-4.3|1.000
71745676|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.5|-47.5|1.000
71745677|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|5.0||||0.765|TWO_SIDED|95.0|-27.8|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||37.8|-27.8|0.765
71745678|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||32.4|-42.4|1.000
71745679|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||32.5|-47.5|1.000
71745680|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|11.3||||0.502|TWO_SIDED|95.0|-21.4|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||43.9|-21.4|0.502
71745681|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-32.9|42.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||42.9|-32.9|1.000
71665869|NCT02006732|142846162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.846|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.24|-2.451|||Mixed Effects Model for Repeated Measure|||||-2.451|-5.240|<0.0001
71745682|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-42.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||37.3|-42.3|1.000
71745683|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|22.5||||0.18|TWO_SIDED|95.0|-9.5|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||54.5|-9.5|0.180
71745684|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||25.6|-45.6|0.702
71745685|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-27.5||||0.214|TWO_SIDED|95.0|-58.9|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||3.9|-58.9|0.214
71834695|NCT03481660|143173910|OTHER|Treatment difference|Clopper-Pearson exact method|5.4|||||TWO_SIDED|95.0|-3.9|14.7||||||Gain of \>= 10 letters in BCVA at Week 52||14.7|-3.9|
71665870|NCT02006732|142846162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.274|STANDARD_ERROR_OF_MEAN|0.702||0.0696|TWO_SIDED|95.0|-2.651|0.102|||Mixed Effects Model for Repeated Measure|||||0.102|-2.651|0.0696
71665871|NCT02006732|142846162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|0.714||0.0003|TWO_SIDED|95.0|-3.971|-1.171|||Mixed Effects Model for Repeated Measure|||||-1.171|-3.971|0.0003
71834696|NCT03481660|143173910|OTHER|Treatment difference|Clopper-Pearson exact method|9.9|||||TWO_SIDED|95.0|-0.4|19.4||||||Gain of \>= 10 letters in BCVA at Week 100||19.4|-0.4|
71834697|NCT03481660|143173911|OTHER|Treatment difference|Clopper-Pearson exact method|9.6|||||TWO_SIDED|95.0|-0.4|20.2||||||Gain of \>= 15 letters in BCVA at Week 52||20.2|-0.4|
71665872|NCT02006732|142846162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.822|STANDARD_ERROR_OF_MEAN|0.698||0.2387|TWO_SIDED|95.0|-2.191|0.546|||Mixed Effects Model for Repeated Measure|||||0.546|-2.191|0.2387
71834698|NCT03481660|143173911|OTHER|Treatment difference|Clopper-Pearson exact method|13.6|||||TWO_SIDED|95.0|3.3|23.5||||||Gain of \>= 15 letters in BCVA at Week 100||23.5|3.3|
71834699|NCT03481660|143173912|OTHER|Treatment difference|Clopper-Pearson exact method|-0.4|||||TWO_SIDED|95.0|-4.2|2.9||||||Loss of \>= 5 letters in BCVA at Week 52||2.9|-4.2|
71834700|NCT03481660|143173912|OTHER|Treatment difference|Clopper-Pearson exact method|-6.0|||||TWO_SIDED|95.0|-10.8|-1.7||||||Loss of \>= 5 letters in BCVA at Week 100||-1.7|-10.8|
71834701|NCT03481660|143173913|OTHER|Treatment difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.2|2.4||||||Loss of \>= 10 letters in BCVA at Week 52||2.4|-3.2|
71834702|NCT03481660|143173913|OTHER|Treatment difference|Clopper-Pearson exact method|-4.1|||||TWO_SIDED|95.0|-8.4|-0.1||||||Loss of \>= 10 letters in BCVA at Week 100||-0.1|-8.4|
71834703|NCT03481660|143173914|OTHER|Treatment difference|Clopper-Pearson exact method|-0.7|||||TWO_SIDED|95.0|-3.2|1.6||||||Loss of \>= 15 letters in BCVA at Week 52||1.6|-3.2|
71834704|NCT03481660|143173914|OTHER|Treatment difference|Clopper-Pearson exact method|-1.3|||||TWO_SIDED|95.0|-4.8|2.0||||||Loss of \>= 15 letters in BCVA at Week 100||2.0|-4.8|
71834705|NCT03481660|143173915|OTHER|Treatment difference|Clopper-Pearson exact method|3.5|||||TWO_SIDED|95.0|-4.9|12.0||||||Absolute BCVA \>= 73 letters at Week 52||12.0|-4.9|
71834706|NCT03481660|143173915|OTHER|Treatment difference|Clopper-Pearson exact method|3.6|||||TWO_SIDED|95.0|-5.4|12.6||||||Absolute BCVA \>= 73 letters at Week 100||12.6|-5.4|
71834707|NCT03481660|143173917|OTHER|Treatment difference|LS mean difference|-29.4|STANDARD_ERROR_OF_MEAN|9.76|<|0.003|TWO_SIDED|95.0|-48.6|-10.2|||ANOVA|||CSFT over period Week 40 through Week 52||-10.2|-48.6|<0.003
71834708|NCT03481660|143173917|SUPERIORITY|||||||0.001|||||||ANOVA|||CSFT over period Week 40 through Week 52||||0.001
71834709|NCT03481660|143173917|OTHER|Treatment difference|LS mean difference|-23.2|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-43.5|-3.0||||||CSFT over period Week 88 through Week 100||-3.0|-43.5|
71834710|NCT03481660|143173918|OTHER|Treatment difference|LS mean difference|-27.4|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-45.8|-9.0||||||CSFT over period Week 4 through Week 52||-9.0|-45.8|
71834711|NCT03481660|143173918|OTHER|Treatment difference|LS mean difference|-25.8|STANDARD_ERROR_OF_MEAN|9.29|||TWO_SIDED|95.0|-44.0|-7.5||||||CSFT over period Week 4 through Week 100||-7.5|-44.0|
71665873|NCT02006732|142846163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.187|0.317|||Mixed Effects Model for Repeated Measure|||||0.317|0.187|<0.0001
71834712|NCT03481660|143173919|OTHER|Treatment difference|Clopper-Pearson exact method|16.3|||||TWO_SIDED|95.0|5.7|25.9||||||CSFT thickness (\<280 micrometers) at Week 52||25.9|5.7|
71834713|NCT03481660|143173919|OTHER|Treatment difference|Clopper-Pearson exact method|14.7|||||TWO_SIDED|95.0|4.2|24.9||||||CSFT thickness (\<280 micrometers) at Week 100||24.9|4.2|
71834714|NCT03481660|143173920|OTHER||Clopper-Pearson exact method|-1.2|||||TWO_SIDED|95.0|-4.5|2.1||||||Subretinal Fluid (SRF) at Week 52||2.1|-4.5|
71834715|NCT03481660|143173920|OTHER|Treatment Difference|Clopper-Pearson exact method|-0.2|||||TWO_SIDED|95.0|-3.4|3.4||||||Subretinal Fluid (SRF) at Week 100||3.4|-3.4|
71665874|NCT02006732|142846163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.033||0.0614|TWO_SIDED|95.0|-0.003|0.125|||Mixed Effects Model for Repeated Measure|||||0.125|-0.003|0.0614
71834716|NCT03481660|143173921|OTHER|Treatment Difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-28.9|-9.2||||||Intraretinal Fluid (IRF) at Week 52||-9.2|-28.9|
71834717|NCT03481660|143173921|OTHER|Treatment Difference|Clopper-Pearson exact method|-16.1|||||TWO_SIDED|95.0|-26.3|-5.7||||||Intraretinal Fluid (IRF) at Week 100||-5.7|-26.3|
71834718|NCT03481660|143173922|OTHER|Treatment Difference|Clopper-Pearson exact method|-18.4|||||TWO_SIDED|95.0|-28.5|-8.3||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 52||-8.3|-28.5|
71834719|NCT03481660|143173922|OTHER|Treatment difference|Clopper-Pearson exact method|-16.2|||||TWO_SIDED|95.0|-26.4|-5.9||||||Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) at Week 100||-5.9|-26.4|
71834720|NCT03481660|143173923|OTHER|Treatment difference|Clopper-Pearson exact method|-25.4|||||TWO_SIDED|95.0|-34.4|-16.3||||||Fluorescein Angiography (FA) at Week 52||-16.3|-34.4|
71834721|NCT03481660|143173923|OTHER|Treatment difference|Clopper-Pearson exact method|-19.1|||||TWO_SIDED|95.0|-29.1|-8.2||||||Fluorescein Angiography (FA) at Week 100||-8.2|-29.1|
71834722|NCT03481660|143173924|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-5.6|7.8||||||\>=2-step improvement in ETDRS-DRSS at Week 52||7.8|-5.6|
71834723|NCT03481660|143173924|OTHER|Treatment difference|Clopper-Pearson exact method|4.5|||||TWO_SIDED|95.0|-1.7|10.8||||||\>=2-step improvement in ETDRS-DRSS at Week 100||10.8|-1.7|
71834724|NCT03481660|143173925|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-7.1|5.7||||||\>=3-step improvement in ETDRS-DRSS at Week 52||5.7|-7.1|
71834725|NCT03481660|143173925|OTHER|Treatment difference|Clopper-Pearson exact method|3.9|||||TWO_SIDED|95.0|-2.3|10.0||||||\>=3-step improvement in ETDRS-DRSS at Week 100||10.0|-2.3|
71834726|NCT03481660|143173926|OTHER|Treatment difference|Clopper-Pearson exact method|1.1|||||TWO_SIDED|95.0|-1.0|3.6||||||\>=2-step worsening in ETDRS-DRSS at Week 52||3.6|-1.0|
71834727|NCT03481660|143173926|OTHER|Treatment difference|Clopper-Pearson exact method|2.9|||||TWO_SIDED|95.0|-0.5|6.9||||||\>=2-step worsening in ETDRS-DRSS at Week 100||6.9|-0.5|
71834728|NCT03481660|143173927|OTHER|Treatment difference|Clopper-Pearson exact method|0.6|||||TWO_SIDED|95.0|0.5|2.1||||||\>=3-step worsening in ETDRS-DRSS at Week 52||2.1|0.5|
71834729|NCT03481660|143173927|OTHER|Treatment difference|Clopper-Pearson exact method|-0.6|||||TWO_SIDED|95.0|-2.6|1.3||||||\>=3-step worsening in ETDRS-DRSS at Week 100||1.3|-2.6|
71834730|NCT03481660|143173928|OTHER|Treatment difference|Clopper-Pearson exact method|0.0|||||TWO_SIDED|95.0|-2.1|1.9||||||Proliferative diabetic retinopathy (PDR) of at least 61 by Week 100||1.9|-2.1|
71834731|NCT05769595|143173960|OTHER||Geometric Mean Ratio|2.51|||||TWO_SIDED|90.0|2.24|2.82|||||Geometric mean ratio is MK-2060/placebo|||2.82|2.24|
71779226|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0568|TWO_SIDED|95.0|0.98|5.44|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.44|0.98|0.0568
71665875|NCT02006732|142846163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.24|0.37|||Mixed Effects Model for Repeated Measure|||||0.370|0.240|<0.0001
71779227|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1268|TWO_SIDED|95.0|0.78|7.46|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.46|0.78|0.1268
71665876|NCT02006732|142846163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.033||0.0005|TWO_SIDED|95.0|0.049|0.178|||Mixed Effects Model for Repeated Measure|||||0.178|0.049|0.0005
71779228|NCT02609828|143058375|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7971|TWO_SIDED|95.0|0.25|6.0|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.00|0.25|0.7971
71779229|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6658|TWO_SIDED|95.0|0.43|3.7|||Regression, Logistic|||Week 1 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.70|0.43|0.6658
71779230|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|3.07||||0.3443|TWO_SIDED|95.0|0.3|31.35|||Regression, Logistic|||Week 1 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||31.35|0.30|0.3443
71779231|NCT02609828|143058376|SUPERIORITY|||||||0.9527|||||||Regression, Logistic|||Week 1 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9527
71779232|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0757|TWO_SIDED|95.0|0.92|5.5|||Regression, Logistic|||Week 2 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.50|0.92|0.0757
71779233|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|4.51||||0.0659|TWO_SIDED|95.0|0.91|22.42|||Regression, Logistic|||Week 2 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||22.42|0.91|0.0659
71665877|NCT02006732|142846163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.126|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|0.126|<0.0001
71779234|NCT02609828|143058376|SUPERIORITY|||||||0.938|||||||Regression, Logistic|||Week 2 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9380
71779235|NCT02609828|143058376|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 2 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
71779236|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0914|TWO_SIDED|95.0|0.89|4.59|||Regression, Logistic|||Week 4 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.59|0.89|0.0914
71834732|NCT03683069|143173966|SUPERIORITY|||||||0.823|||||||Regression, Linear|||adjusted to medication dose, sex, age, race||||0.823
71834733|NCT03683069|143173966|SUPERIORITY|||||||0.839|||||||Regression, Linear|||diastolic bp adjusted for medication dose sex,age, race||||.8390
71834734|NCT03683069|143173967|SUPERIORITY|||||||0.0101|||||||Wilcoxon (Mann-Whitney)|||||||.0101
71834735|NCT03683069|143173968|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
71834736|NCT03683069|143173969|SUPERIORITY||Hazard Ratio, log|0.7022||||0.09|TWO_SIDED||||||Kaplan-Meier using Gehan-Breslow-Wilcoxo|||||||.09
71665878|NCT02006732|142846163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.033||0.1089|TWO_SIDED|95.0|-0.117|0.012|||Mixed Effects Model for Repeated Measure|||||0.012|-0.117|0.1089
71665879|NCT02006732|142846164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.195|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.665|1.725|||Mixed Effects Model for Repeated Measure|||||1.725|0.665|<0.0001
71665880|NCT02006732|142846164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.267||0.0296|TWO_SIDED|95.0|0.058|1.106|||Mixed Effects Model for Repeated Measure|||||1.106|0.058|0.0296
71834737|NCT04065048|143173970|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
71834738|NCT04065048|143173971|OTHER|||||||0.0093|||||||ANOVA|||||||0.0093
71834739|NCT04065048|143173973|OTHER|||||||0.2487|||||||Fisher Exact|||||||0.2487
71834740|NCT05307978|143174004|SUPERIORITY||Ratio (%)|68.729|||||TWO_SIDED|95.0|52.74|89.56|||Mixed Models Analysis|A mixed effect model was performed to the ln-transformed PK parameter and the independent variables.||||89.56|52.74|
71834741|NCT05307978|143174005|SUPERIORITY||Ratio (%)|120.043|||||TWO_SIDED|95.0|67.2|214.43|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||214.43|67.20|
71665881|NCT02006732|142846164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|0.73|1.796|||Mixed Effects Model for Repeated Measure|||||1.796|0.730|<0.0001
71745686|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.0|-2.5|0.086
71779237|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0359|TWO_SIDED|95.0|1.08|9.61|||Regression, Logistic|||Week 4 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.61|1.08|0.0359
71779238|NCT02609828|143058376|SUPERIORITY|||||||0.9538|||||||Regression, Logistic|||Week 4 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9538
71779239|NCT02609828|143058376|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 4 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
71779240|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0143|TWO_SIDED|95.0|1.22|5.8|||Regression, Logistic|||Week 6 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.80|1.22|0.0143
71745687|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-37.2|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||37.2|-37.2|1.000
71745688|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|7.5||||1|TWO_SIDED|95.0|-31.6|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||46.6|-31.6|1.000
71745689|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|32.5||||0.051|TWO_SIDED|95.0|1.4|63.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.6|1.4|0.051
71745690|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||34.8|-34.8|1.000
71779241|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0176|TWO_SIDED|95.0|1.28|13.74|||Regression, Logistic|||Week 6 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||13.74|1.28|0.0176
71779242|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|3.53||||0.1298|TWO_SIDED|95.0|0.69|18.06|||Regression, Logistic|||Week 6 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||18.06|0.69|0.1298
71779243|NCT02609828|143058376|SUPERIORITY|||||||0.9493|||||||Regression, Logistic|||Week 6 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||||0.9493
71834742|NCT05307978|143174006|SUPERIORITY||Ratio (%)|118.142|||||TWO_SIDED|95.0|73.93|188.8|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||188.80|73.93|
71834743|NCT05307978|143174007|SUPERIORITY||Ratio (%)|93.891|||||TWO_SIDED|95.0|63.17|139.56|||Mixed Models Analysis|A mixed effect model was performed with ethnicity as fixed effect and participant as random effect.||||139.56|63.17|
71834744|NCT03547908|143174012|NON_INFERIORITY|A sample size of 240 participants randomized in a 1:1 ratio to 2 treatment groups, achieved 90% power to detect a non-inferiority margin of 12% between the 2 treatment groups. For the sample size and power computation, it is assumed that both treatment groups have a response rate of 91% (based on Gilead Studies GS-US-380-1489 and GS-US-380-1490), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|4.1|||||TWO_SIDED|95.001|-2.5|10.8|||||The difference in percentages of participants between groups and their 95.001% confidence intervals (CI)s were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||10.8|-2.5|
71834745|NCT03547908|143174012|SUPERIORITY|||||||0.2113|||||||Cochran-Mantel-Haenszel|The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).||||||0.2113
71665882|NCT02006732|142846164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.269||0.0159|TWO_SIDED|95.0|0.122|1.178|||Mixed Effects Model for Repeated Measure|||||1.178|0.122|0.0159
71745691|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||60.0|-5.0|0.075
71745692|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.2|-18.6|0.705
71745693|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.4|-20.0|1.000
71745694|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||60.0|-5.0|0.075
71779244|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0527|TWO_SIDED|95.0|0.99|4.67|||Regression, Logistic|||Week 8 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.67|0.99|0.0527
71779245|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0457|TWO_SIDED|95.0|1.02|7.12|||Regression, Logistic|||Week 8 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||7.12|1.02|0.0457
71779246|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0994|TWO_SIDED|95.0|0.77|19.76|||Regression, Logistic|||Week 8 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||19.76|0.77|0.0994
71779247|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|0.65||||0.6977|TWO_SIDED|95.0|0.07|5.86|||Regression, Logistic|||Week 8 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.86|0.07|0.6977
71779248|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.76||||0.146|TWO_SIDED|95.0|0.82|3.75|||Regression, Logistic|||Week 12 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.75|0.82|0.1460
71779249|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0742|TWO_SIDED|95.0|0.92|6.01|||Regression, Logistic|||Week 12 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.01|0.92|0.0742
71779250|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5565|TWO_SIDED|95.0|0.42|4.91|||Regression, Logistic|||Week 12 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.91|0.42|0.5565
71779251|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.7||||0.5623|TWO_SIDED|95.0|0.28|10.35|||Regression, Logistic|||Week 12 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||10.35|0.28|0.5623
71779252|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.86||||0.0116|TWO_SIDED|95.0|1.27|6.47|||Regression, Logistic|||Week 16 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.47|1.27|0.0116
71779253|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0615|TWO_SIDED|95.0|0.96|5.7|||Regression, Logistic|||Week 16 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.70|0.96|0.0615
71745695|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-3.7||||0.705|TWO_SIDED|95.0|-18.6|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.2|-18.6|0.705
71665883|NCT02006732|142846164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.613|STANDARD_ERROR_OF_MEAN|0.273||0.0248|TWO_SIDED|95.0|0.078|1.148|||Mixed Effects Model for Repeated Measure|||||1.148|0.078|0.0248
71665884|NCT02006732|142846164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.266||0.7984|TWO_SIDED|95.0|-0.59|0.454|||Mixed Effects Model for Repeated Measure|||||0.454|-0.590|0.7984
71665885|NCT02006732|142846165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.623|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.245|2.0|||Mixed Effects Model for Repeated Measure|||||2.000|1.245|<0.0001
71665886|NCT02006732|142846165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.594|STANDARD_ERROR_OF_MEAN|0.19||0.0019|TWO_SIDED|95.0|0.22|0.967|||Mixed Effects Model for Repeated Measure|||||0.967|0.220|0.0019
71665887|NCT02006732|142846165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.611|STANDARD_ERROR_OF_MEAN|0.193|<|0.0001|TWO_SIDED|95.0|1.232|1.989|||Mixed Effects Model for Repeated Measure|||||1.989|1.232|<0.0001
71665888|NCT02006732|142846165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.191||0.0023|TWO_SIDED|95.0|0.207|0.956|||Mixed Effects Model for Repeated Measure|||||0.956|0.207|0.0023
71665889|NCT02006732|142846165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|0.194|<|0.0001|TWO_SIDED|95.0|0.649|1.41|||Mixed Effects Model for Repeated Measure|||||1.410|0.649|<0.0001
71665890|NCT02006732|142846165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.189||0.9494|TWO_SIDED|95.0|-0.359|0.383|||Mixed Effects Model for Repeated Measure|||||0.383|-0.359|0.9494
71665891|NCT02006732|142846166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.432|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.366|0.498|||Mixed Effects Model for Repeated Measure|||||0.498|0.366|<0.0001
71665892|NCT02006732|142846166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.084|0.212|||Mixed Effects Model for Repeated Measure|||||0.212|0.084|<0.0001
71665893|NCT02006732|142846166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.387|0.522|||Mixed Effects Model for Repeated Measure|||||0.522|0.387|<0.0001
71665894|NCT02006732|142846166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.105|0.236|||Mixed Effects Model for Repeated Measure|||||0.236|0.105|<0.0001
71665895|NCT02006732|142846166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.217|0.35|||Mixed Effects Model for Repeated Measure|||||0.350|0.217|<0.0001
71665896|NCT02006732|142846166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.033||0.4974|TWO_SIDED|95.0|-0.087|0.042|||Mixed Effects Model for Repeated Measure|||||0.042|-0.087|0.4974
71665897|NCT01198132|142846199|SUPERIORITY_OR_OTHER||Rate ratio|0.8||||0.3797|TWO_SIDED|95.0|0.48|1.32|||Poisson log-linear model|||||1.32|0.48|0.3797
71665898|NCT03516513|142846209|SUPERIORITY|t-tests||||||0.905|||||||t-test, 2 sided|||||||0.905
71665899|NCT03516513|142846209|SUPERIORITY|t-test||||||0.32|||||||t-test, 2 sided|||||||.320
71665900|NCT03516513|142846210|SUPERIORITY|||||||0.155||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.155
71665901|NCT03516513|142846210|SUPERIORITY|||||||0.974||||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.974
71665902|NCT03516513|142846212|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||||||.212
71665903|NCT03516513|142846213|SUPERIORITY|||||||0.507|||||||t-test, 2 sided|||||||.507
71745696|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|0.5||||1|TWO_SIDED|95.0|-17.4|18.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||18.5|-17.4|1.000
71665904|NCT03516513|142846214|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||.091
71665905|NCT00345631|142846224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.68|||<|0.0001|TWO_SIDED|95.0|-19.04|-12.31||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis: The mean time to hemostasis for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-12.31|-19.04|<0.0001
71665906|NCT00345631|142846225|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.7||||0.0028|TWO_SIDED|95.0|-5.53|-1.87||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis:The mean time to ambulation for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"||-1.87|-5.53|0.0028
71665907|NCT00345631|142846226|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is adequate to rule out a 4% or larger disadvantage for VCD vs. MC (null hypothesis: 2.5% MC vs. 6.5% VCD) in the incidence of major complications for VCD vs. MC using a 95% upper confidence bound for the VCD - MC difference with 80% power and a 5% one-sided Type I error|Mean Difference (Final Values)|0.0||||0.0006|ONE_SIDED|95.0||1.14||P-value was calculated using unconditional exact test of non-inferiority for difference of two binomial proportions (VCD vs. MC) with a margin of 4%.|unconditional exact test|||Based on pre-planned hypotheses, a minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) would demonstrate non-inferiority for the primary safety endpoint and superiority for both co-primary effectiveness endpoints in comparing VCD vs. MC.||1.14||0.0006
71665908|NCT00345631|142846227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.154|TWO_SIDED|95.0|-7.84|0.45|||t-test, 2 sided|||Null hypothesis: The mean time to eligibility for hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||0.45|-7.84|0.1540
71834746|NCT03547908|143174013|NON_INFERIORITY|A sample size of 240 participants provided 81% power to detect a non-inferiority margin of 12% between the 2 treatment groups. This assumed that both treatment groups have a response rate of 88% (based on Gilead Studies GS-US-320-0108 and GS-US-320-0110), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|16.6|||||TWO_SIDED|95.001|5.9|27.3|||||||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95.001% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|27.3|5.9|
71745697|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.8|-20.5|1.000
71745698|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-6.4||||0.348|TWO_SIDED|95.0|-18.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||5.2|-18.0|0.348
71745699|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||20.7|-13.4|0.686
71745700|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|7.5||||0.616|TWO_SIDED|95.0|-19.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||34.8|-19.8|0.616
71745701|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-6.6||||0.42|TWO_SIDED|95.0|-20.5|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.3|-20.5|0.420
71745702|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-20.0|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||12.4|-20.0|1.000
71745703|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||21.8|-20.5|1.000
71745704|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||13.3|-14.4|1.000
71745705|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.7|-13.4|0.686
71745706|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|9.4||||0.555|TWO_SIDED|95.0|-21.9|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.6|-21.9|0.555
71745707|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-2.7||||0.83|TWO_SIDED|95.0|-27.2|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||21.8|-27.2|0.830
71745708|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-36.0|0.518
71745709|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|12.5||||0.428|TWO_SIDED|95.0|-18.6|43.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||43.6|-18.6|0.428
71745710|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|3.9||||0.757|TWO_SIDED|95.0|-20.7|28.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||28.4|-20.7|0.757
71834747|NCT03547908|143174013|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|The p-value was from CMH test stratified by baseline HBeAg status (positive vs negative) and HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||||||0.0023
71745711|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|4.6||||0.745|TWO_SIDED|95.0|-23.2|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||32.4|-23.2|0.745
71665909|NCT00345631|142846228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.3612|TWO_SIDED|95.0|-7.46|2.31|||t-test, 2 sided|||Null hypothesis: The mean time to hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.||2.31|-7.46|0.3612
71745712|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.8||||1|TWO_SIDED|95.0|-34.6|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.0|-34.6|1.000
71745713|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|3.6||||0.773|TWO_SIDED|95.0|-20.6|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||27.7|-20.6|0.773
71745714|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-29.4|0.838
71745715|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-12.9||||0.497|TWO_SIDED|95.0|-40.0|14.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||14.1|-40.0|0.497
71745716|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||34.9|-14.0|0.404
71745717|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-2.8||||0.838|TWO_SIDED|95.0|-29.4|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.8|-29.4|0.838
71745718|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|3.6||||1|TWO_SIDED|95.0|-24.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||31.6|-24.4|1.000
71745719|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|16.4||||0.174|TWO_SIDED|95.0|-7.0|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.8|-7.0|0.174
71745720|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|6.6||||0.611|TWO_SIDED|95.0|-19.1|32.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||32.3|-19.1|0.611
71745721|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
71745722|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|0.488
71779254|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3316|TWO_SIDED|95.0|0.59|4.8|||Regression, Logistic|||Week 16 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||4.80|0.59|0.3316
71745723|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||4.6|-14.6|1.000
71745724|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
71745725|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||0.488|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|0.488
71745726|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
71834748|NCT03547908|143174014|SUPERIORITY||Difference in Percentages|-0.3||||0.9427|TWO_SIDED|95.0|-8.9|8.3||P-value for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups was from the CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||8.3|-8.9|0.9427
71834749|NCT03547908|143174015|OTHER||Difference in least squares mean (LSM)|24.0||||0.1701|TWO_SIDED|95.0|-10.0|58.0|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||58|-10|0.1701
71834750|NCT03547908|143174016|OTHER||Difference in Least Squares Means|30.0||||0.1853|TWO_SIDED|95.0|-14.0|74.0||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||74|-14|0.1853
71834751|NCT03547908|143174017|OTHER||Difference in least squares mean (LSM)|0.59||||0.2839|TWO_SIDED|95.0|-0.49|1.67|||ANOVA|The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL).|||1.67|-0.49|0.2839
71834752|NCT03547908|143174018|OTHER||Difference in LSM|0.13||||0.8456|TWO_SIDED|95.0|-1.2|1.46||P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|ANOVA||Difference in LSM and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|||1.46|-1.20|0.8456
71745727|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
71745728|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.0|-13.4|1.000
71745729|NCT02365649|143002018|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||4.6|-14.6|1.000
71745730|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||45.5|-72.2|1.000
71891027|NCT02537678|143304094|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|ONE_SIDED|97.5|-2.94||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.94|<0.001
71891028|NCT02537678|143304095|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|2.25||0.044|ONE_SIDED|97.5|-6.33||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.33|.044
71745731|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.1|-50.2|1.000
71779255|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9946|TWO_SIDED|95.0|0.19|5.33|||Regression, Logistic|||Week 16 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.33|0.19|0.9946
71779256|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0083|TWO_SIDED|95.0|1.33|6.76|||Regression, Logistic|||Week 24 Reduction \>=30%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||6.76|1.33|0.0083
71779257|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.42||||0.0513|TWO_SIDED|95.0|1.0|5.88|||Regression, Logistic|||Week 24 Reduction \>=50%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||5.88|1.00|0.0513
71779258|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1528|TWO_SIDED|95.0|0.71|8.58|||Regression, Logistic|||Week 24 Reduction \>=70%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||8.58|0.71|0.1528
71779259|NCT02609828|143058376|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7251|TWO_SIDED|95.0|0.21|9.65|||Regression, Logistic|||Week 24 Reduction \>=90%: Logistic regression model included baseline average pain intensity at the index bone metastasis cancer pain site, baseline worst pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||9.65|0.21|0.7251
71779260|NCT02609828|143058377|SUPERIORITY||Difference in LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.12||0.7045|TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||Change at Week 2: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.19|-0.28|0.7045
71779261|NCT02609828|143058377|SUPERIORITY||Difference in LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0402|TWO_SIDED|95.0|-0.59|-0.01|||ANCOVA|||Change at Week 4: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||-0.01|-0.59|0.0402
71779262|NCT02609828|143058377|SUPERIORITY||Difference in LS mean|-0.33|STANDARD_ERROR_OF_MEAN|0.17||0.0637|TWO_SIDED|95.0|-0.67|0.02|||ANCOVA|||Change at Week 8: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.02|-0.67|0.0637
71779263|NCT02609828|143058377|SUPERIORITY||Difference in LS mean|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3804|TWO_SIDED|95.0|-0.53|0.2|||ANCOVA|||Change at Week 16: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.20|-0.53|0.3804
71891029|NCT02537678|143304096|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.75||0.002|ONE_SIDED|97.5|-3.07||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.07|0.002
71779264|NCT02609828|143058377|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5894|TWO_SIDED|95.0|-0.47|0.27|||ANCOVA|||Change at Week 24: ANCOVA model for imputed datasets included treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and baseline global assessment score, baseline average pain intensity at the index bone metastasis cancer pain site, and baseline opioid dose as covariates.||0.27|-0.47|0.5894
71779265|NCT02609828|143058378|SUPERIORITY||Odds Ratio (OR)|0.38||||0.2033|TWO_SIDED|95.0|0.09|1.69|||Regression, Logistic|||Week 2: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||1.69|0.09|0.2033
71779266|NCT02609828|143058378|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7627|TWO_SIDED|95.0|0.41|3.41|||Regression, Logistic|||Week 4: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.41|0.41|0.7627
71779267|NCT02609828|143058378|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6894|TWO_SIDED|95.0|0.44|3.43|||Regression, Logistic|||Week 8: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.43|0.44|0.6894
71779268|NCT02609828|143058378|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5905|TWO_SIDED|95.0|0.47|3.83|||Regression, Logistic|||Week 16: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.83|0.47|0.5905
71779269|NCT02609828|143058378|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8354|TWO_SIDED|95.0|0.38|3.35|||Regression, Logistic|||Week 24: Logistic regression model included baseline PGA-CP, baseline average pain intensity at the index bone metastasis cancer pain site, treatment, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness).||3.35|0.38|0.8354
71779270|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8069|TWO_SIDED|95.0|-0.49|0.38|||Mixed Models Analysis|||Week 2 Frequency Composite Score: Mixed model for repeated measurements (MMRM) model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.38|-0.49|0.8069
71779271|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.17||0.7127|TWO_SIDED|95.0|-0.28|0.41|||Mixed Models Analysis|||Week 4 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.28|0.7127
71779272|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.17|STANDARD_ERROR_OF_MEAN|0.2||0.3933|TWO_SIDED|95.0|-0.57|0.23|||Mixed Models Analysis|||Week 8 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.23|-0.57|0.3933
71779273|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5869|TWO_SIDED|95.0|-0.71|0.41|||Mixed Models Analysis|||Week 16 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.71|0.5869
71779274|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.42|STANDARD_ERROR_OF_MEAN|0.3||0.1814|TWO_SIDED|95.0|-1.05|0.21|||Mixed Models Analysis|||Week 24 Frequency Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS frequency scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.21|-1.05|0.1814
71779275|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2822|TWO_SIDED|95.0|-0.14|0.46|||Mixed Models Analysis|||Week 2 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.46|-0.14|0.2822
71779276|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5795|TWO_SIDED|95.0|-0.23|0.41|||Mixed Models Analysis|||Week 4 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.41|-0.23|0.5795
71779277|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5486|TWO_SIDED|95.0|-0.42|0.22|||Mixed Models Analysis|||Week 8 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.22|-0.42|0.5486
71779278|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3692|TWO_SIDED|95.0|-0.24|0.63|||Mixed Models Analysis|||Week 16 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.24|0.3692
71779279|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4724|TWO_SIDED|95.0|-0.3|0.63|||Mixed Models Analysis|||Week 24 Severity Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS severity scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.63|-0.30|0.4724
71779280|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.23||0.477|TWO_SIDED|95.0|-0.3|0.64|||Mixed Models Analysis|||Week 2 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.64|-0.30|0.4770
71779281|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.9791|TWO_SIDED|95.0|-0.38|0.37|||Mixed Models Analysis|||Week 4 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.38|0.9791
71891030|NCT02537678|143304097|NON_INFERIORITY|We planned 0.41 standard deviation (SD) as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.52||0.016|ONE_SIDED|97.5|-4.06||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.06|0.016
71665910|NCT00345631|142846231|SUPERIORITY_OR_OTHER||Proportion difference|0.7||||0.85|TWO_SIDED|95.0|-4.8|7.4|||t-test, 2 sided|||Null hypothesis: The percentages of patients achieving procedure success between the vascular closure device and manual compression arms are equal.||7.4|-4.8|0.85
71665911|NCT00509795|142846249|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.4|3.1|||||The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.||3.1|-4.4|
71665912|NCT00509795|142846249|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.1|-5.1|2.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||2.1|-5.1|
71665913|NCT00509795|142846249|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.1|-4.5|3.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).||3.1|-4.5|
71665914|NCT00509795|142846250|SUPERIORITY_OR_OTHER||Differences in Least Squares means|3.15||||0.0054|TWO_SIDED|95.1|0.92|5.37||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||5.37|0.92|0.0054
71665915|NCT00509795|142846250|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.8||||0.4793|TWO_SIDED|95.1|-3.03|1.43||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.43|-3.03|0.4793
71665916|NCT00509795|142846250|SUPERIORITY_OR_OTHER||Differences in Least Squares Means|0.26||||0.8179|TWO_SIDED|95.1|-1.97|2.49||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||2.49|-1.97|0.8179
71745732|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||44.8|-4.8|1.000
71745733|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-23.3||||0.423|TWO_SIDED|95.0|-79.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||33.2|-79.8|0.423
71745734|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-32.9||||0.25|TWO_SIDED|95.0|-74.0|8.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||8.2|-74.0|0.250
71779282|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.23|STANDARD_ERROR_OF_MEAN|0.25||0.3574|TWO_SIDED|95.0|-0.27|0.74|||Mixed Models Analysis|||Week 8 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.74|-0.27|0.3574
71834753|NCT03547908|143174019|SUPERIORITY|P-value for the superiority test comparing the percentages of participants with HBV DNA \< 29 IU/mL between treatment groups was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in Percentages|2.6||||0.6367|TWO_SIDED|95.0|-8.3|13.4|||Cochran-Mantel-Haenszel|||The difference in percentages of participants with HBV DNA \< 29 IU/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).||13.4|-8.3|0.6367
71834754|NCT03547908|143174020|OTHER||Difference in Percentages|17.1||||0.0655|TWO_SIDED|95.0|-1.5|35.7|||Cochran-Mantel-Haenszel|P-value was calculated from CMH tests stratified by baseline HBeAg status (positive vs negative) and HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|The difference in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||35.7|-1.5|0.0655
71834755|NCT03547908|143174021|OTHER||Difference in Percentages|14.1||||0.1253|TWO_SIDED|95.0|-4.3|32.6|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|Difference in the proportion between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs \>= 8 log10 IU/mL).|||32.6|-4.3|0.1253
71834756|NCT03547908|143174022|OTHER||Difference in Percentages|7.1||||0.0591|TWO_SIDED|95.0|-0.8|15.0|||Cochran-Mantel-Haenszel|P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative)and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|Difference in the percentages between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||15.0|-0.8|0.0591
71745735|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-8.6|28.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.6|-8.6|1.000
71745736|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|20.0||||1|TWO_SIDED|95.0|-4.8|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.8|-4.8|1.000
71745737|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||33.1|-50.2|1.000
71745738|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||45.5|-72.2|1.000
71891031|NCT02537678|143304098|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|1.77||0.003|ONE_SIDED|97.5|-3.72||||t-test, 1 sided|||Based on the actual randomization of 183 participants (SC-TF-CBT=91; standard TF-CBT=92), we had more than 80% power to show that SC-TF-CBT is at least as effective as standard TF-CBT with alpha of .05 and a non-inferior margin of 0.41 standard deviation units.|Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.72|0.003
71779283|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5607|TWO_SIDED|95.0|-0.77|0.42|||Mixed Models Analysis|||Week 16 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.42|-0.77|0.5607
71779284|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7143|TWO_SIDED|95.0|-0.68|0.47|||Mixed Models Analysis|||Week 24 Distress Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS distress scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.47|-0.68|0.7143
71779285|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6381|TWO_SIDED|95.0|-0.28|0.45|||Mixed Models Analysis|||Week 2 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.45|-0.28|0.6381
71891032|NCT02537678|143304099|NON_INFERIORITY|We planned 0.41 standard deviation the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.89||0.007|ONE_SIDED|97.5|-3.89||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.89|0.007
71665917|NCT00509795|142846251|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.6||||0.1042|TWO_SIDED|95.1|-1.0|14.1||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The null hypothesis is that both percentages are equal.||14.1|-1.0|0.1042
71665918|NCT00509795|142846251|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-6.0||||0.1037|TWO_SIDED|95.1|-13.2|1.2||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The null hypothesis is that both percentages are equal.||1.2|-13.2|0.1037
71665919|NCT00509795|142846251|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.93|TWO_SIDED|95.1|-7.7|7.0||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.|The pairwise The null hypothesis is that both percentages are equal.||7.0|-7.7|0.93
71665920|NCT00509795|142846252|SUPERIORITY_OR_OTHER||Differences Least Squares means|1.28||||0.209|TWO_SIDED|95.1|-0.73|3.28||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||3.28|-0.73|0.2090
71745739|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-46.7||||0.203|TWO_SIDED|95.0|-100.0|12.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||12.2|-100.0|0.203
71745740|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-8.6||||1|TWO_SIDED|95.0|-50.2|33.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||33.1|-50.2|1.000
71745741|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-72.2|45.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||45.5|-72.2|1.000
71745742|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
71745743|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|11.4||||1|TWO_SIDED|95.0|-33.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||56.6|-33.8|1.000
71745744|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-54.7|68.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||68.0|-54.7|1.000
71745745|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
71779286|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|0.06|STANDARD_ERROR_OF_MEAN|0.15||0.7181|TWO_SIDED|95.0|-0.25|0.37|||Mixed Models Analysis|||Week 4 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.37|-0.25|0.7181
71779287|NCT02609828|143058381|SUPERIORITY||Difference in least square (LS) mean|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8378|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Week 8 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.31|-0.38|0.8378
71665921|NCT00509795|142846252|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.67||||0.5128|TWO_SIDED|95.1|-2.69|1.35||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.35|-2.69|0.5128
71745746|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
71745747|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
71665922|NCT00509795|142846252|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.6||||0.5579|TWO_SIDED|95.1|-2.61|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-2.61|0.5579
71665923|NCT00509795|142846253|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.33||||0.3575|TWO_SIDED|95.1|-1.04|0.38||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||0.38|-1.04|0.3575
71745748|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
71745749|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||70.8|-100.0|1.000
71745750|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||86.7|-20.0|1.000
71745751|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-100.0|42.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||42.1|-100.0|1.000
71745752|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
71779288|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.23||0.795|TWO_SIDED|95.0|-0.52|0.4|||Mixed Models Analysis|||Week 16 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.52|0.7950
71779289|NCT02609828|143058381|SUPERIORITY||Difference in LS mean|-0.11|STANDARD_ERROR_OF_MEAN|0.25||0.6719|TWO_SIDED|95.0|-0.62|0.4|||Mixed Models Analysis|||Week 24 MDA Composite Score: MMRM model includes time (study week), treatment, region, and randomization stratification variables (concomitant anticancer treatment and tumor aggressiveness) as fixed effects, and treatment\*time interaction, baseline OR-SDS MDA scores, and baseline average pain intensity at the index bone metastasis cancer pain site as covariates.||0.40|-0.62|0.6719
71779290|NCT04424888|143058394|SUPERIORITY|||||||0.21875|||||||Wilcoxon (Mann-Whitney)|||||||0.21875
71779291|NCT04424888|143058395|SUPERIORITY|||||||0.90625|||||||Wilcoxon (Mann-Whitney)|||||||0.90625
71779292|NCT04424888|143058396|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||Paired t-test for the species Akkermansia Munciphilae.||||0.020
71779293|NCT04424888|143058396|SUPERIORITY|||||||0.078|||||||t-test, 1 sided|||Paired t-test for the species Bifidobacterium infantis.||||0.078
71779294|NCT04424888|143058396|SUPERIORITY|||||||||||||||||Paired t-test for the species Clostridium beijerinckii.|No statistical test was conducted since Clostridium beijerinckii was not detected in any sample.|||
71779295|NCT04424888|143058396|SUPERIORITY|||||||0.2|||||||t-test, 1 sided|||Paired t-test for the species Clostridium butyricum.||||0.20
71779296|NCT04424888|143058396|SUPERIORITY|||||||0.12|||||||t-test, 1 sided|||Paired t-test for the species Anaerobutyricum hallii.||||0.12
71779297|NCT04424888|143058397|OTHER||||||||||||||||||All participants had the same number of sensors (3) throughout the study, so no statistical analysis is conducted.|||
71779298|NCT04424888|143058398|SUPERIORITY|||||||0.41|||||||t-test, 1 sided|||We test whether the average number of daily photos is greater in period 1 than in period 2.||||0.41
71779299|NCT04424888|143058399|SUPERIORITY|||||||0.13|||||||t-test, 1 sided|||We test whether the average time between consecutive scans is smaller in period 1 than in period 2.||||0.13
71779300|NCT02390908|143058426|SUPERIORITY||Beta|0.22||||0.39|TWO_SIDED|95.0|-0.28|0.72||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.72|-0.28|0.39
71779301|NCT02390908|143058426|SUPERIORITY||Beta|-0.03||||0.94|TWO_SIDED|95.0|-0.84|0.79||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.79|-0.84|0.94
71834757|NCT03547908|143174023|OTHER||Difference in Percentages|9.3||||0.0655|TWO_SIDED|95.0|-0.7|19.2||P value was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL). Statistically significant values are shown in bold.|Cochran-Mantel-Haenszel||Differences in percentages between treatment groups and their 95% CI were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (\< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).|||19.2|-0.7|0.0655
71745753|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
71745754|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||75.4|-75.4|1.000
71745755|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
71745756|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
71745757|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-75.4|75.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||75.4|-75.4|1.000
71745758|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-86.7|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||20.0|-86.7|1.000
71745759|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
71745760|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|6.4||||1|TWO_SIDED|90.0|-31.2|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||44.0|-31.2|1.000
71745761|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-48.6|0.655
71779302|NCT02390908|143058426|SUPERIORITY||Beta|0.02||||0.95|TWO_SIDED|95.0|-0.69|0.74||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.74|-0.69|0.95
71834758|NCT05075408|143174034|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|7.0||||0.3696|TWO_SIDED|97.5|-10.6|24.6||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 30 mg versus Placebo||24.6|-10.6|0.3696
71834759|NCT05075408|143174034|SUPERIORITY|Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.|Strata adjusted percentage difference|14.5||||0.0686|TWO_SIDED|97.5|-3.1|32.2||Threshold of significance at 0.025.|Cochran-Mantel-Haenszel|||Nemolizumab 60 mg versus Placebo||32.2|-3.1|0.0686
71834760|NCT05075408|143174035|SUPERIORITY||Strata adjusted percentage difference|4.3||||0.5909|TWO_SIDED|97.5|-13.8|22.3|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||22.3|-13.8|0.5909
71834761|NCT05075408|143174035|SUPERIORITY||Strata adjusted percentage difference|12.9||||0.1112|TWO_SIDED|97.5|-5.5|31.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||31.4|-5.5|0.1112
71745762|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|23.1||||0.541|TWO_SIDED|95.0|0.2|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.0|0.2|0.541
71891033|NCT02537678|143304100|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.64||0.008|ONE_SIDED|97.5|-4.24||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.24|0.008
71745763|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-1.3||||1|TWO_SIDED|95.0|-37.0|34.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||34.4|-37.0|1.000
71745764|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-29.1||||0.178|TWO_SIDED|95.0|-67.0|8.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||8.9|-67.0|0.178
71745765|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|15.4||||1|TWO_SIDED|95.0|-4.2|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.0|-4.2|1.000
71745766|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-54.4|33.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||33.9|-54.4|1.000
71779303|NCT02390908|143058426|SUPERIORITY||Beta|-0.32||||0.09|TWO_SIDED|95.0|-0.69|0.05||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||0.05|-0.69|0.09
71834762|NCT05075408|143174036|SUPERIORITY||Strata adjusted percentage difference|17.3||||0.0034|TWO_SIDED|97.5|4.3|30.4|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.4|4.3|0.0034
71834763|NCT05075408|143174036|SUPERIORITY||Strata adjusted percentage difference|17.1||||0.0025|TWO_SIDED|97.5|4.5|29.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||29.8|4.5|0.0025
71834764|NCT05075408|143174037|SUPERIORITY||Strata adjusted percentage difference|3.7||||0.5788|TWO_SIDED|97.5|-12.5|19.8|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||19.8|-12.5|0.5788
71745767|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-48.6|0.655
71745768|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||46.3|-50.1|1.000
71745769|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-26.9||||0.32|TWO_SIDED|95.0|-73.0|19.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||19.2|-73.0|0.320
71745770|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-10.3||||0.655|TWO_SIDED|95.0|-48.6|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||28.1|-48.6|0.655
71745771|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-1.9||||1|TWO_SIDED|95.0|-50.1|46.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.3|-50.1|1.000
71891034|NCT02537678|143304101|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|1.78||0.015|ONE_SIDED|97.5|-4.88||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.88|0.015
71745772|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-52.2|44.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.5|-52.2|1.000
71779304|NCT02390908|143058426|SUPERIORITY||Slope|-0.03||||0.79|TWO_SIDED|95.0|-0.24|0.18||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.18|-0.24|0.79
71779305|NCT02390908|143058426|SUPERIORITY||Slope|-0.12||||0.57|TWO_SIDED|95.0|-0.53|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.53|0.57
71779306|NCT02390908|143058426|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.35|0.36||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to the No-Treatment EMR Control.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.36|-0.35|0.97
71779307|NCT02390908|143058426|SUPERIORITY||Slope|0.07||||0.41|TWO_SIDED|95.0|-0.1|0.24||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in log VL across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.24|-0.10|0.41
71779308|NCT02390908|143058426|SUPERIORITY||Slope|0.06||||0.82|TWO_SIDED|95.0|-0.41|0.52||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.52|-0.41|0.82
71779309|NCT02390908|143058426|SUPERIORITY||Slope|0.14||||0.49|TWO_SIDED|95.0|-0.26|0.53||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.53|-0.26|0.49
71779310|NCT02390908|143058426|SUPERIORITY||Slope|-0.33||||0.18|TWO_SIDED|95.0|-0.8|0.15||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.15|-0.80|0.18
71779311|NCT02390908|143058426|SUPERIORITY||Slope|0.02||||0.89|TWO_SIDED|95.0|-0.28|0.32||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||0.32|-0.28|0.89
71779312|NCT02390908|143058427|SUPERIORITY||Beta|1.92||||0.95|TWO_SIDED|95.0|-54.68|58.53||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||58.53|-54.68|0.95
71779313|NCT02390908|143058427|SUPERIORITY||Beta|23.99||||0.61|TWO_SIDED|95.0|-67.54|115.51||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||115.51|-67.54|0.61
71779314|NCT02390908|143058427|SUPERIORITY||Beta|-23.71||||0.48|TWO_SIDED|95.0|-88.82|41.4||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 3 on CD4 Count was estimated against the No-Treatment Control EMR Group.|||41.40|-88.82|0.48
71834765|NCT05075408|143174037|SUPERIORITY||Strata adjusted percentage difference|16.5||||0.0303|TWO_SIDED|97.5|-0.8|33.9|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||33.9|-0.8|0.0303
71834766|NCT05075408|143174038|SUPERIORITY||Strata adjusted percentage difference|24.2||||0.0006|TWO_SIDED|97.5|8.8|39.6|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||39.6|8.8|0.0006
71834767|NCT05075408|143174038|SUPERIORITY||Strata adjusted percentage difference|20.8||||0.0021|TWO_SIDED|97.5|6.0|35.7|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||35.7|6.0|0.0021
71834768|NCT05075408|143174039|SUPERIORITY||Strata adjusted percentage difference|14.0||||0.0028|TWO_SIDED|97.5|3.8|24.1|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||24.1|3.8|0.0028
71834769|NCT05075408|143174039|SUPERIORITY||Strata adjusted percentage difference|19.0||||0.0003|TWO_SIDED|97.5|7.6|30.5|||Cochran-Mantel-Haenszel|||Analysis was performed using hierarchical testing procedure. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.025.||30.5|7.6|0.0003
71891035|NCT02537678|143304102|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|1.99||0.024|ONE_SIDED|97.5|-5.68||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.68|0.024
71891036|NCT02537678|143304103|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.001|ONE_SIDED|97.5|-0.39||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.39|0.001
71891037|NCT02537678|143304104|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.22||0.003|ONE_SIDED|97.5|-0.47||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.47|0.003
71891038|NCT02537678|143304105|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|ONE_SIDED|97.5|-0.3||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.30|<0.001
71891039|NCT02537678|143304106|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.14||0.001|ONE_SIDED|97.5|-0.29||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.29|0.001
71891040|NCT02537678|143304107|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.004|ONE_SIDED|97.5|-0.38||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.38|0.004
71891041|NCT02537678|143304108|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|ONE_SIDED|97.5|-0.19||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-0.19|<0.001
71891042|NCT02537678|143304109|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.47||0.005|ONE_SIDED|97.5|-3.33||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.33|0.005
71891043|NCT02537678|143304110|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.78||0.028|ONE_SIDED|97.5|-4.99||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-4.99|0.028
71891044|NCT02537678|143304111|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.62||0.009|ONE_SIDED|97.5|-3.64||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-3.64|0.009
71891045|NCT02537678|143304112|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.9||0.006|ONE_SIDED|97.5|-2.82||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.82|0.006
71891046|NCT02537678|143304113|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.88||0.001|ONE_SIDED|97.5|-2.31||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-2.31|0.001
71745773|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|1.7||||1|TWO_SIDED|95.0|-40.6|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||44.0|-40.6|1.000
71745774|NCT02365649|143002019|SUPERIORITY||Risk Difference (RD)|21.2||||0.603|TWO_SIDED|95.0|-29.2|71.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||71.5|-29.2|0.603
71891047|NCT02537678|143304114|NON_INFERIORITY|We planned 0.41 standard deviation as the non-inferiority margin (which is less than half of the effect size) for the one-side testing. Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Median Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|ONE_SIDED|97.5|-1.43||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-1.43|<0.001
71891048|NCT02537678|143304115|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at post assessment.|Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|ONE_SIDED|97.5|-5.04||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.04|<0.001
71665924|NCT00509795|142846253|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.71||||0.0507|TWO_SIDED|95.1|-0.01|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.42|-0.01|0.0507
71665925|NCT00509795|142846253|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.86||||0.0173|TWO_SIDED|95.1|0.15|1.58||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.||1.58|0.15|0.0173
71665926|NCT04324073|142846308|SUPERIORITY||Median posterior absolute risk differenc|0.2|||||TWO_SIDED|90.0|-11.7|12.2||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||12.2|-11.7|
71665927|NCT04324073|142846309|SUPERIORITY||Median posterior Hazard Ratio|1.1|||||TWO_SIDED|90.0|0.69|1.74||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible interval here|||1.74|0.69|
71665928|NCT04324073|142846310|SUPERIORITY||Median posterior absolute risk differenc|-7.3|||||TWO_SIDED|90.0|-22.5|8.7||Posterior probability|Bayesian analysis|Adjusted on age and centre|% Confidence Interval is %Credible Interval here. Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||8.7|-22.5|
71665929|NCT04324073|142846311|SUPERIORITY||Median posterior Hazard Ratio|1.05|||||TWO_SIDED|90.0|0.55|2.07||Posterior probability|Bayesian analysis||% Confidence Interval is % Credible Interval here|||2.07|0.55|
71665930|NCT04324073|142846312|SUPERIORITY|Day 14|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.23|2.03|||Regression, Cox|adjusted for age and sex||||2.03|0.23|
71665931|NCT04324073|142846312|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.27|1.59|||Regression, Cox|||Day 28||1.59|0.27|
71779315|NCT02390908|143058427|SUPERIORITY||Beta|4.19||||0.88|TWO_SIDED|95.0|-49.76|58.14||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3 (the Waitlist condition) and the No-Treatment Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of being in the Waitlist condition (i.e., not receiving the PLUS intervention at Site 3) on log-transformed Viral Load was estimated against the No-Treatment Control EMR Group.|||58.14|-49.76|0.88
71779316|NCT02390908|143058427|SUPERIORITY||Slope|7.67||||0.59|TWO_SIDED|95.0|-19.88|35.21||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||35.21|-19.88|0.59
71891049|NCT02537678|143304116|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults. Non-inferiority analysis with alpha 2.5% was applied at 6-month assessment.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.27||0.003|ONE_SIDED|97.5|-6.87||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-6.87|0.003
71665932|NCT04324073|142846312|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.31|1.58|||Regression, Cox|||Day 90||1.58|0.31|
71665933|NCT04324073|142846312|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.4|2.25|||Regression, Cox|||Day 14||2.25|0.40|
71665934|NCT04324073|142846312|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.4|1.96|||Regression, Cox|||Day 28||1.96|0.40|
71665935|NCT04324073|142846312|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.35|1.58|||Regression, Cox|||Day 90||1.58|0.35|
71665936|NCT04324073|142846313|SUPERIORITY||Median posterior OR|1.11|||||TWO_SIDED|95.0|0.53|2.34|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.34|0.53|
71665937|NCT04324073|142846313|SUPERIORITY||Median posterior OR|1.02|||||TWO_SIDED|95.0|0.49|2.08|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 7||2.08|0.49|
71665938|NCT04324073|142846313|SUPERIORITY||Median posterior OR|0.79|||||TWO_SIDED|95.0|0.42|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||1.47|0.42|
71665939|NCT04324073|142846313|SUPERIORITY||Median posterior OR|0.88|||||TWO_SIDED|95.0|0.38|2.02|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 4||2.02|0.38|
71665940|NCT04324073|142846313|SUPERIORITY||Median posterior OR|1.07|||||TWO_SIDED|95.0|0.47|2.4|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre.|% Confidence Interval is % Credible Interval here|Day 14||2.40|0.47|
71665941|NCT04324073|142846313|SUPERIORITY||Median posterior OR|1.13|||||TWO_SIDED|95.0|0.5|2.57|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 90||2.57|0.50|
71665942|NCT04324073|142846314|SUPERIORITY||Median Difference (Net)|-1.5|||||TWO_SIDED|95.0|-6.1|3.9||||adjusted on age and centre||||3.9|-6.1|
71665943|NCT04324073|142846315|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.72|1.57|||Fine-Gray model|adjusted for age and centre||Day 28||1.57|0.72|
71665944|NCT04324073|142846315|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.74|2.25|||Fine-Gray model|Adjusted for age and centre||Day 90||2.25|0.74|
71665945|NCT04324073|142846315|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.59|2.44|||Fine-Gray model|adjusted for age and centre||Day 28||2.44|0.59|
71665946|NCT04324073|142846315|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.74|1.55|||Fine-Gray model|Adjusted for age and centre||Day 90||1.55|0.74|
71665947|NCT04324073|142846316|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.81|1.75|||Fine-Gray model|Adjusted on age and centre||Day 28||1.75|0.81|
71665948|NCT04324073|142846316|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.8|1.67|||Fine-Gray model|Adjusted on age and centre||Day 90||1.67|0.80|
71665949|NCT04324073|142846316|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.55|2.66|||Fine-Gray model|Adjusted on age and centre||Day 28||2.66|0.55|
71665950|NCT04324073|142846316|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.71|2.37|||Fine-Gray model|Adjusted on age and centre||Day 90||2.37|0.71|
71665951|NCT04324073|142846317|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.42|1.44|||Fine-Gray model|Adjusted for age and centre||Day 28||1.44|0.42|
71665952|NCT04324073|142846317|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.49|1.47|||Fine-Gray model|adjusted for age and centre||Day 90||1.47|0.49|
71665953|NCT05833139|142846319|OTHER||Geometric mean ratio (T/R) [%]|141.2|||||TWO_SIDED|90.0|126.3|157.7|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 18.0|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-∞ was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||157.7|126.3|
71665954|NCT05833139|142846320|OTHER||Geometric mean ratio (T/R) [%]|126.9|||||TWO_SIDED|90.0|106.6|151.0|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 28.7|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. Cmax was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||151.0|106.6|
71665955|NCT05833139|142846321|OTHER||Geometric mean ratio (T/R) [%]|142.8|||||TWO_SIDED|90.0|126.0|161.9|||ANOVA||Intra-individual geometric coefficient of variation (gCV%) = 20.4|"The statistical model used was an analysis of variance (ANOVA) on the logarithmic scale. AUC0-tz was log transformed (natural logarithm) prior to fitting the ANOVA model, considering the effect 'participant' as random and treatment as fixed."||161.9|126.0|
71665956|NCT03785600|142846331|OTHER||||||<|0.02||||||a priori threshold is \<0.05.|t-test, 2 sided|||||||<0.02
71665957|NCT02567435|142846339|SUPERIORITY||3-Year EFS|65.8||||0.44|TWO_SIDED||||||Log Rank|||||||0.44
71665958|NCT02567435|142846340|SUPERIORITY||3-Year OS|78.2||||0.56|TWO_SIDED||||||Log Rank|||||||0.56
71665959|NCT04856930|142846378|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.25||0.7841|TWO_SIDED|90.0|-2.42|1.73||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|Linear repeated measures model (LRMM)|||||1.73|-2.42|0.7841
71745775|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|15.4||||0.673|TWO_SIDED|95.0|-25.6|56.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||56.5|-25.6|0.673
71745776|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|19.6||||0.265|TWO_SIDED|95.0|-14.0|53.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||53.3|-14.0|0.265
71745777|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|12.9||||0.695|TWO_SIDED|95.0|-25.6|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||51.5|-25.6|0.695
71745778|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-20.6||||0.394|TWO_SIDED|95.0|-61.4|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||20.3|-61.4|0.394
71745779|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-3.9||||1|TWO_SIDED|95.0|-36.1|28.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||28.3|-36.1|1.000
71745780|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-10.6||||0.683|TWO_SIDED|95.0|-47.9|26.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||26.7|-47.9|0.683
71779317|NCT02390908|143058427|SUPERIORITY||Slope|-24.95||||0.24|TWO_SIDED|95.0|-66.78|16.88||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||16.88|-66.78|0.24
71779318|NCT02390908|143058427|SUPERIORITY||Slope|18.32||||0.15|TWO_SIDED|95.0|-6.63|43.27||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||43.27|-6.63|0.15
71665960|NCT04856930|142846378|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.25||0.2885|TWO_SIDED|90.0|-0.74|3.4||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||3.40|-0.74|0.2885
71745781|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|28.7||||0.205|TWO_SIDED|95.0|-4.1|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||61.4|-4.1|0.205
71891050|NCT02537678|143304117|NON_INFERIORITY|For the non-inferiority margin for the PCL-5, the clinically significant change threshold is 10 points although adult PTSD trials have used -5 to -10 points. We used -8.8 as the margin which was based on an expert panel and prior studies with adults.Non-inferiority analysis with alpha 2.5% was applied at 12-month assessment.|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|2.06|<|0.001|ONE_SIDED|97.5|-5.8||||t-test, 1 sided||||Treatment difference = standard TF-CBT - stepped care TF-CBT||-5.80|<0.001
71891051|NCT03168867|143304124|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<.05
71891052|NCT05003115|143304188|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-6.36||||0.101|TWO_SIDED|95.0|-14.17|1.44|||Regression, Linear|||||1.44|-14.17|0.101
71891053|NCT05003115|143304189|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||Regression, Linear|||||0.59|-0.79|0.78
71891054|NCT05003115|143304190|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.95||||0.314|TWO_SIDED|95.0|-2.83|0.94|||Regression, Linear|||||0.94|-2.83|0.314
71891055|NCT05003115|143304191|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.04||||0.679|TWO_SIDED|95.0|-6.0|3.92|||Regression, Linear|||||3.92|-6.00|0.679
71891056|NCT05003115|143304192|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|0.01||||0.994|TWO_SIDED|95.0|-2.23|2.25|||Regression, Linear|||||2.25|-2.23|0.994
71891057|NCT05003115|143304193|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-1.22||||0.258|TWO_SIDED|95.0|-3.33|0.89|||Regression, Linear|||||0.89|-3.33|0.258
71891058|NCT05003115|143304194|SUPERIORITY||Mean Diff. Adjusting for Baseline Values|-0.4||||0.857|TWO_SIDED|95.0|-4.75|3.96|||Regression, Linear|||||3.96|-4.75|0.857
71891059|NCT01147809|143304201|SUPERIORITY_OR_OTHER||Percent difference|21.1||||0.103|TWO_SIDED|95.0|-3.9|52.5|||ANCOVA|||||52.5|-3.9|0.103
71891060|NCT01147809|143304223|SUPERIORITY_OR_OTHER||Percent difference|12.9||||0.407|TWO_SIDED|95.0|-15.6|51.1|||ANCOVA|||||51.1|-15.6|0.407
71891061|NCT01147809|143304224|SUPERIORITY_OR_OTHER||Percent difference|-4.4||||0.802|TWO_SIDED|95.0|-33.5|37.4|||ANCOVA|||||37.4|-33.5|0.802
71891062|NCT01307423|143304232|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.1||||0.0062|TWO_SIDED|95.0|3.5|20.7|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.7|3.5|0.0062
71891063|NCT01307423|143304232|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|6.1|23.5|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||23.5|6.1|0.0010
71891064|NCT01307423|143304233|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0008|TWO_SIDED|95.0|-0.265|-0.071|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.071|-0.265|0.0008
71891065|NCT01307423|143304233|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.217|||<|0.0001|TWO_SIDED|95.0|-0.314|-0.12|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.120|-0.314|<.0001
71891066|NCT01307423|143304234|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1||||0.0002|TWO_SIDED|95.0|7.7|24.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.4|7.7|0.0002
71891067|NCT01307423|143304234|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4||||0.0063|TWO_SIDED|95.0|3.3|19.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.4|3.3|0.0063
71891068|NCT01307423|143304235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.168||||0.0014|TWO_SIDED|95.0|-0.271|-0.065||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.065|-0.271|0.0014
71891069|NCT01307423|143304235|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.219|||<|0.0001|TWO_SIDED|95.0|-0.322|-0.117||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate||||-0.117|-0.322|<.0001
71891070|NCT01307423|143304236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.38||||0.0043|TWO_SIDED|95.0|0.75|4.01||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.01|0.75|0.0043
71745782|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|14.5||||0.388|TWO_SIDED|95.0|-17.9|46.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||46.9|-17.9|0.388
71745783|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-28.8||||0.236|TWO_SIDED|95.0|-65.6|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||8.0|-65.6|0.236
71745784|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-9.6||||1|TWO_SIDED|95.0|-50.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-50.6|1.000
71745785|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|26.3||||0.131|TWO_SIDED|95.0|-6.3|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.9|-6.3|0.131
71745786|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-7.1||||1|TWO_SIDED|95.0|-45.6|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.5|-45.6|1.000
71745787|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|21.3||||0.411|TWO_SIDED|95.0|-19.6|62.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||62.2|-19.6|0.411
71745788|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|32.2||||0.067|TWO_SIDED|95.0|-0.2|64.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.5|-0.2|0.067
71745789|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-1.2||||1|TWO_SIDED|95.0|-39.5|37.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||37.2|-39.5|1.000
71745790|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|26.6||||0.178|TWO_SIDED|95.0|-8.8|62.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||62.0|-8.8|0.178
71891071|NCT01307423|143304236|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.18||||0.0002|TWO_SIDED|95.0|1.55|4.82||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate||||4.82|1.55|0.0002
71891072|NCT01307423|143304237|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.4||||0.0037|TWO_SIDED|95.0|4.8|24.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.0|4.8|0.0037
71891073|NCT01307423|143304237|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|21.0|||<|0.0001|TWO_SIDED|95.0|11.3|30.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||30.7|11.3|<.0001
71891074|NCT01307423|143304238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.0485|TWO_SIDED|95.0|-10.0|0.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-0.0|-10.0|0.0485
71891075|NCT01307423|143304238|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.8||||0.0022|TWO_SIDED|95.0|-12.8|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||||-2.8|-12.8|0.0022
71665961|NCT04856930|142846379|SUPERIORITY||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|8.97||0.5939|TWO_SIDED|90.0|-19.66|10.07||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||10.07|-19.66|0.5939
71745791|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.7||||0.72|TWO_SIDED|95.0|-23.8|12.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||12.3|-23.8|0.720
71779319|NCT02390908|143058427|SUPERIORITY||Slope|10.27||||0.33|TWO_SIDED|95.0|-10.2|30.74||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 1 estimated here represents linear change in CD4 count across the 3-,6-,9- and 12-month follow-ups for Waitlist relative to No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||30.74|-10.20|0.33
71745792|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-7.9||||0.683|TWO_SIDED|95.0|-27.2|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||11.5|-27.2|0.683
71745793|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|23.0||||0.215|TWO_SIDED|95.0|-12.8|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||58.9|-12.8|0.215
71745794|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-12.3||||0.279|TWO_SIDED|95.0|-30.4|5.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||5.8|-30.4|0.279
71745795|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-6.4||||0.716|TWO_SIDED|95.0|-28.2|15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||15.4|-28.2|0.716
71745796|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-27.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.1|-27.5|1.000
71745797|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||7.1|-23.5|0.400
71745798|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-19.6|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||21.0|-19.6|1.000
71745799|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|7.9||||0.62|TWO_SIDED|95.0|-22.2|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||38.0|-22.2|0.620
71745800|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-8.2||||0.4|TWO_SIDED|95.0|-23.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||7.1|-23.5|0.400
71834770|NCT03358875|143174068|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.527|0.778||OS in the ITT population was tested at one-sided p value boundary of 0.0120.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.778|0.527|<0.0001
71665962|NCT04856930|142846379|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|8.95||0.7002|TWO_SIDED|90.0|-11.38|18.29||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates; baseline AN count as continuous covariate.|LRMM|||||18.29|-11.38|0.7002
71745801|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-4.3||||1|TWO_SIDED|95.0|-22.7|14.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.2|-22.7|1.000
71745802|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|4.0||||1|TWO_SIDED|95.0|-18.7|26.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.6|-18.7|1.000
71779320|NCT02390908|143058427|SUPERIORITY||Slope|6.42||||0.8|TWO_SIDED|95.0|-44.24|57.09||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 1 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||57.09|-44.24|0.80
71834771|NCT03358875|143174069|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.407|0.702||OS in the PD-L1 positive analysis set was tested at the one-sided p-value boundary of 0.025.|1-sided Log Rank Test|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).||||0.702|0.407|<0.0001
71665963|NCT04856930|142846380|SUPERIORITY||Risk Difference (RD)|5.3|||||TWO_SIDED|90.0|-13.3|23.4|||||Estimate parameter and 90% CI was based on Unadjusted Risk Difference and exact unconditional confidence intervals (CI).|||23.4|-13.3|
71745803|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|5.0||||0.678|TWO_SIDED|95.0|-9.7|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.6|-9.7|0.678
71745804|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|7.9||||0.636|TWO_SIDED|95.0|-10.5|26.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||26.2|-10.5|0.636
71745805|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|21.4||||0.19|TWO_SIDED|95.0|-9.7|52.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||52.5|-9.7|0.190
71745806|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|9.0||||0.504|TWO_SIDED|95.0|-17.3|35.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||35.3|-17.3|0.504
71745807|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|1.6||||0.916|TWO_SIDED|95.0|-27.8|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||31.0|-27.8|0.916
71745808|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-31.7|31.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||31.7|-31.7|1.000
71745809|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-9.0||||0.504|TWO_SIDED|95.0|-35.3|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-35.3|0.504
71745810|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-7.1||||0.635|TWO_SIDED|95.0|-36.6|22.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||22.3|-36.6|0.635
71745811|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|10.7||||0.513|TWO_SIDED|95.0|-21.1|42.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.5|-21.1|0.513
71779321|NCT02390908|143058427|SUPERIORITY||Slope|-5.43||||0.89|TWO_SIDED|95.0|-85.47|74.61||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in CD4 count across the 12-,15-, and 18-month follow-ups for Site 2 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||74.61|-85.47|0.89
71745812|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|1.7||||0.898|TWO_SIDED|95.0|-24.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||28.1|-24.7|0.898
71779322|NCT02390908|143058427|SUPERIORITY||Slope|1.16||||0.97|TWO_SIDED|95.0|-60.61|62.94||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Site 3 relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||62.94|-60.61|0.97
71779323|NCT02390908|143058427|SUPERIORITY||Slope|-38.4||||0.07|TWO_SIDED|95.0|-79.51|2.72||Piecemeal latent growth curves (LGC) were specified with intercepts and linear slopes. Slope 2 estimated here represents linear change in log VL across the 12-,15-, and 18-month follow-ups for Waitlist relative to the No-Treatment EMR Control Group.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.||||2.72|-79.51|0.07
71779324|NCT02390908|143058428|SUPERIORITY||Beta|-7.87||||0.22|TWO_SIDED|95.0|-20.52|4.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||4.78|-20.52|0.22
71834772|NCT03358875|143174070|SUPERIORITY||Odds Ratio (OR)|3.86|||<|0.0001|TWO_SIDED|95.0|2.336|6.393|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, line of therapy, and PDL1 expression.||||6.393|2.336|<0.0001
71834773|NCT03358875|143174071|SUPERIORITY||Odds Ratio (OR)|8.04|||<|0.0001|TWO_SIDED|95.0|3.721|17.379|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology and line of therapy.||||17.379|3.721|<0.0001
71665964|NCT04856930|142846380|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|90.0|-14.6|21.0|||||Estimate parameter and 90% C was based on Unadjusted Risk Difference and exact unconditional CIs.|||21.0|-14.6|
71745813|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-13.1||||0.379|TWO_SIDED|95.0|-41.7|15.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||15.5|-41.7|0.379
71745814|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-3.6||||0.822|TWO_SIDED|95.0|-34.5|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.4|-34.5|0.822
71745815|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|8.9||||0.508|TWO_SIDED|95.0|-17.3|35.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||35.0|-17.3|0.508
71745816|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-6.0||||0.683|TWO_SIDED|95.0|-34.3|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||22.4|-34.3|0.683
71745817|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|14.3||||0.49|TWO_SIDED|95.0|-16.6|45.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||45.1|-16.6|0.490
71745818|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|23.3||||0.078|TWO_SIDED|95.0|-1.9|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.5|-1.9|0.078
71745819|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|10.3||||0.466|TWO_SIDED|95.0|-17.7|38.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||38.4|-17.7|0.466
71745820|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
71745821|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|0.447
71745822|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.3|-17.1|1.000
71745823|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-11.8||||1|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|1.000
71779325|NCT02390908|143058428|SUPERIORITY||Beta|10.29||||0.22|TWO_SIDED|95.0|-6.25|26.82||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and pre-baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||26.82|-6.25|0.22
71745824|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-11.8||||0.193|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.193
71745825|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-11.8||||0.498|TWO_SIDED|95.0|-27.1|3.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||3.6|-27.1|0.498
71745826|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
71891076|NCT01307423|143304239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.7696|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||0.6|-0.8|0.7696
71665965|NCT04856930|142846381|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7282|TWO_SIDED|90.0|-1.08|0.7||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.70|-1.08|0.7282
71745827|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|0.447
71745828|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||5.3|-17.1|1.000
71745829|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
71745830|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||0.447|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|0.447
71745831|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||5.3|-17.1|1.000
71745832|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
71745833|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-1.1||||1|TWO_SIDED|95.0|-15.5|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||13.3|-15.5|1.000
71745834|NCT02365649|143002020|SUPERIORITY||Risk Difference (RD)|-5.9||||1|TWO_SIDED|95.0|-17.1|5.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||5.3|-17.1|1.000
71745835|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-57.2|43.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||43.9|-57.2|1.000
71745836|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||55.8|-9.2|0.323
71745837|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|33.3||||0.516|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||60.0|6.7|0.516
71745838|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-31.7||||0.191|TWO_SIDED|95.0|-77.4|14.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||14.0|-77.4|0.191
71745839|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-26.0|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||22.6|-26.0|1.000
71745840|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||24.0|-7.3|1.000
71891077|NCT01307423|143304239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.0038|TWO_SIDED|95.0|-1.7|-0.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.3|-1.7|0.0038
71745841|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|33.3||||0.261|TWO_SIDED|95.0|6.7|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||60.0|6.7|0.261
71745842|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||55.8|-9.2|0.323
71745843|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||58.5|-41.8|1.000
71745844|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-26.7||||0.593|TWO_SIDED|95.0|-77.2|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||23.9|-77.2|0.593
71745845|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|23.3||||0.323|TWO_SIDED|95.0|-9.2|55.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.8|-9.2|0.323
71834774|NCT03358875|143174072|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.176|0.536|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.536|0.176|<0.0001
71834775|NCT03358875|143174073|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.066|0.37|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.370|0.066|<0.0001
71834776|NCT03358875|143174074|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.528|0.745|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous), line of therapy (second vs third), and PDL1 expression (≥25% vs \<25% TC).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% CI.|||0.745|0.528|<0.0001
71891078|NCT01307423|143304240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.2|-1.6|
71665966|NCT04856930|142846381|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.54||0.5019|TWO_SIDED|90.0|-1.25|0.53||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||0.53|-1.25|0.5019
71745846|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-41.8|58.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||58.5|-41.8|1.000
71745847|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|21.7||||0.6|TWO_SIDED|95.0|-23.1|66.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||66.5|-23.1|0.600
71745848|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|31.7||||0.162|TWO_SIDED|95.0|-1.9|65.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||65.2|-1.9|0.162
71745849|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-34.1|67.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||67.4|-34.1|1.000
71745850|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-50.5|77.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||77.2|-50.5|1.000
71745851|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-100.0|1.000
71834777|NCT03358875|143174075|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.285|0.494|||Log Rank|Stratified by stratification factors: histology (squamous vs non-squamous) and line of therapy (second vs third).|A stratified Cox proportional hazards model with Efron's method of tie handling was used to determine hazard ratio (HR) and its 95% confidence interval (CI).|||0.494|0.285|<0.0001
71745852|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||86.7|-20.0|1.000
71834778|NCT03358875|143174076|OTHER||Least Squares (LS) Mean Difference|5.7||||0.0008|TWO_SIDED|95.0|2.38|9.07|||Mixed Models Analysis|||The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||9.07|2.38|0.0008
71834779|NCT03358875|143174077|OTHER||LS Mean Difference|-8.3||||0.0007|TWO_SIDED|95.0|-13.02|-3.51|||Mixed Models Analysis|||Analysis of Change from Baseline in Coughing Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||-3.51|-13.02|0.0007
71665967|NCT04856930|142846382|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7698|TWO_SIDED|90.0|-0.96|0.67||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.67|-0.96|0.7698
71834780|NCT03358875|143174077|OTHER||LS Mean Difference|-3.2||||0.0579|TWO_SIDED|95.0|-6.52|0.11|||Mixed Models Analysis|||Analysis of Change from Baseline in Dyspnoea Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||0.11|-6.52|0.0579
71665968|NCT04856930|142846382|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.7468|TWO_SIDED|90.0|-0.97|0.65||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||0.65|-0.97|0.7468
71745853|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-40.0||||0.464|TWO_SIDED|95.0|-82.9|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||2.9|-82.9|0.464
71745854|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-50.0||||0.4|TWO_SIDED|95.0|-100.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||19.3|-100.0|0.400
71745855|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-46.7||||0.464|TWO_SIDED|95.0|-100.0|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||17.2|-100.0|0.464
71745856|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||70.8|-100.0|1.000
71745857|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||86.7|-20.0|1.000
71745858|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-26.7||||1|TWO_SIDED|95.0|-95.1|41.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||41.8|-95.1|1.000
71745859|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-16.7||||1|TWO_SIDED|95.0|-100.0|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||70.8|-100.0|1.000
71745860|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|33.3||||1|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||86.7|-20.0|1.000
71745861|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-77.2|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-77.2|1.000
71834781|NCT03358875|143174077|OTHER||LS Mean Difference|-2.2||||0.2472|TWO_SIDED|95.0|-6.05|1.56|||Mixed Models Analysis|||Analysis of Change from Baseline in Chest Pain Scale. The linear mixed-effect model for repeated measures (MMRM) includes baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects and visit as a repeated measure.||1.56|-6.05|0.2472
71834782|NCT03599648|143174080|SUPERIORITY|||||||0.361||||||baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.361
71834783|NCT03599648|143174080|SUPERIORITY|||||||0.126||||||baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.126
71834784|NCT03599648|143174080|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
71779326|NCT02390908|143058428|SUPERIORITY||Beta|-0.27||||0.96|TWO_SIDED|95.0|-11.63|11.08||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on ART Medication Adherence was estimated against Site 3's Waitlist Control Group.|||11.08|-11.63|0.96
71779327|NCT02390908|143058428|SUPERIORITY||Slope|6.34||||0.03|TWO_SIDED|95.0|0.72|11.97||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.97|0.72|0.03
71779328|NCT02390908|143058428|SUPERIORITY||Slope|3.35||||0.42|TWO_SIDED|95.0|-4.78|11.47||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||11.47|-4.78|0.42
71779329|NCT02390908|143058428|SUPERIORITY||Slope|0.34||||0.91|TWO_SIDED|95.0|-5.85|6.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in Medication Adherence across 3-,6-,9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||6.54|-5.85|0.91
71834785|NCT03599648|143174080|SUPERIORITY|||||||0||||||baseline versus immediately after 16 week BPT-M intervention|t-test, 2 sided|||||||.000
71834786|NCT03599648|143174080|SUPERIORITY|||||||0||||||baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
71834787|NCT03599648|143174080|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
71834788|NCT03599648|143174081|SUPERIORITY|||||||0.035||||||Baseline versus immediately following 16-week BPT-E intervention|t-test, 2 sided|||||||.035
71834789|NCT03599648|143174081|SUPERIORITY|||||||0.001||||||Baseline versus 6-months after BPT-E intervention|t-test, 2 sided|||||||.001
71834790|NCT03599648|143174081|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
71834791|NCT03599648|143174081|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
71834792|NCT03599648|143174081|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
71834793|NCT03599648|143174081|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
71834794|NCT03599648|143174082|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-E intervention|t-test, 2 sided|||||||.000
71834795|NCT03599648|143174082|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-E intervention|t-test, 2 sided|||||||.000
71834796|NCT03599648|143174082|SUPERIORITY|||||||0||||||Baseline versus 12 months after BPT-E intervention|t-test, 2 sided|||||||.000
71834797|NCT03599648|143174082|SUPERIORITY|||||||0||||||Baseline versus immediately after 16-week BPT-M intervention|t-test, 2 sided|||||||.000
71834798|NCT03599648|143174082|SUPERIORITY|||||||0||||||Baseline versus 6 months after BPT-M intervention|t-test, 2 sided|||||||.000
71834799|NCT03599648|143174082|SUPERIORITY|||||||0||||||baseline versus 12 months after BPT-M intervention|t-test, 2 sided|||||||.000
71834800|NCT02380612|143174084|OTHER||Geometric Mean Ratio|1.4575|||||TWO_SIDED|||||||||||||
71834801|NCT02879448|143174093|NON_INFERIORITY|The non-inferiority margin was developed based on reported rates for other devices. Therefore, the expected rate of the safety endpoint was assumed to be 15%. A non-inferiority margin of 5.8% represents a relative risk of 1.39.||||||0.0002|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p1(Amulet) - p1 (Watchman) ≥ Δ1~H1: p1(Amulet) - p1(Watchman) \< Δ1;~where Δ1 is the absolute value of the non-inferiority margin for the safety endpoint and p1 is the probability of a primary safety endpoint event."||||0.0002
71834802|NCT02879448|143174094|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported rates of ischemic stroke or systemic embolism for the Watchman. The 18-month rate of ischemic stroke or systemic embolism for the Watchman device has been reported in the literature as 4.2%. A non-inferiority margin of 3.2%, which represents a relative risk of 1.76, ensured that the rate observed was at most twice the rate expected with oral anticoagulant therapy.|||||<|0.0001|||||||Kaplan-Meier estimate|||"The following hypothesis was tested:~H0: p2(Amulet) - p2(Watchman) ≥ Δ2~H1: p2(Amulet) - p2(Watchman) \< Δ2;~where Δ2 is the absolute value of the non-inferiority margin for the effectiveness endpoint and p2 is the probability of a subject experiencing a primary effectiveness endpoint event."||||<0.0001
71834803|NCT02879448|143174095|NON_INFERIORITY|The non-inferiority margin for this endpoint was developed based on the reported closure rate for the Watchman device. The rate of device closure for the Watchman device has been reported in the literature as 95% (i.e., 5% had a residual jet \> 5mm). A non-inferiority margin of -3%, which represents a relative risk of 1.60, allows for trial to trial variability and implanter learning associated with implantation of a new device (Amulet).|||||<|0.0001|||||||Farrington Manning test|||"The following hypothesis was tested:~H0: p3(Amulet) - p3(Watchman) ≤ -Δ3~H1: p3(Amulet) - p3(Watchman) \> -Δ3;~where Δ3 is the absolute value of the non-inferiority margin and p3 is the 45-day closure probability."||||<0.0001
71834804|NCT02879448|143174096|NON_INFERIORITY|"The following hypothesis was tested:~H1: p4(Amulet) - p4(Watchman) \< 4.5%"|||||<|0.0001|||||||Kaplan-Meier estimate|||||||<0.0001
71834805|NCT02879448|143174097|SUPERIORITY|"The following hypothesis was tested:~H1: p5(Amulet) - p5(Watchman) \< 0"||||||0.3229|||||||Kaplan-Meier estimate|||||||0.3229
71834806|NCT02879448|143174098|SUPERIORITY|"The following hypothesis was tested:~H1: p1(Amulet) - p1(Watchman) \< 0"||||||0.466|||||||Kaplan-Meier estimate|||||||0.4660
71834807|NCT02879448|143174099|SUPERIORITY|"The following hypothesis was tested:~H1: p2(Amulet) - p2(Watchman) \< 0"||||||0.5017|||||||Kaplan-Meier estimate|||||||0.5017
71834808|NCT02879448|143174100|SUPERIORITY|"The following hypothesis was tested:~H1: p3(Amulet) - p3(Watchman) \> 0"||||||0.0025|||||||Farrington Manning test|||||||0.0025
71834809|NCT03433339|143174104|SUPERIORITY||||||=|0.04||||||p-value threshold for statistical significance \<0.05|ANOVA|Mixed ANOVA model considering all available data.||||||=0.040
71745862|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-70.8|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|-70.8|1.000
71745863|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|66.7||||1|TWO_SIDED|95.0|13.3|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||100.0|13.3|1.000
71745864|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-33.8|40.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||40.4|-33.8|1.000
71745865|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.5|-15.2|0.408
71745866|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|33.3||||0.266|TWO_SIDED|95.0|9.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.2|9.5|0.266
71745867|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-33.3||||0.121|TWO_SIDED|95.0|-66.2|-0.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||-0.5|-66.2|0.121
71745868|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-10.0||||-10|TWO_SIDED|95.0|-34.6|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||14.6|-34.6|-10.0
71745869|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-6.0|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.3|-6.0|1.000
71745870|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-45.3|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.9|-45.3|1.000
71745871|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||48.5|-15.2|0.408
71745872|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||55.7|-29.1|1.000
71745873|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-26.7||||0.241|TWO_SIDED|95.0|-65.3|11.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||11.9|-65.3|0.241
71665969|NCT04856930|142846383|SUPERIORITY||LS Mean Difference|-25.7|STANDARD_ERROR_OF_MEAN|23.46||0.275|TWO_SIDED|90.0|-64.57|13.14||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||13.14|-64.57|0.2750
71745874|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|16.7||||0.408|TWO_SIDED|95.0|-15.2|48.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||48.5|-15.2|0.408
71745875|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-29.1|55.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||55.7|-29.1|1.000
71779330|NCT02390908|143058429|SUPERIORITY||Beta|3.19||||0.02|TWO_SIDED|95.0|0.61|5.78||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 1 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 1 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||5.78|0.61|0.02
71665970|NCT04856930|142846383|SUPERIORITY||LS Mean Difference|-21.2|STANDARD_ERROR_OF_MEAN|23.81||0.3757|TWO_SIDED|90.0|-60.6|18.28||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline worst HS Pain NRS as a continuous covariate.|LRMM|||||18.28|-60.60|0.3757
71665971|NCT04856930|142846384|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|13.04||0.6146|TWO_SIDED|90.0|-28.22|15.05||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||15.05|-28.22|0.6146
71665972|NCT04856930|142846384|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|12.95||0.4951|TWO_SIDED|90.0|-30.35|12.62||LS Mean, Standard error, 90% CI, p-value based on LRMM which included: treatment, visit, treatment by visit interaction, and Hurley Stage at baseline (II vs. III) as categorical covariates and baseline average HS Pain NRS as a continuous covariate.|LRMM|||||12.62|-30.35|0.4951
71665973|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.1089|STANDARD_ERROR_OF_MEAN|0.212||0.6102|TWO_SIDED|90.0|-0.4656|0.2477|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2477|-0.4656|0.6102
71665974|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.1266|STANDARD_ERROR_OF_MEAN|0.2076||0.5452|TWO_SIDED|90.0|-0.4758|0.2225|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2225|-0.4758|0.5452
71665975|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.1682|STANDARD_ERROR_OF_MEAN|0.2055||0.4178|TWO_SIDED|90.0|-0.5139|0.1775|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.1775|-0.5139|0.4178
71665976|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.4885|STANDARD_ERROR_OF_MEAN|0.2075||0.0233|TWO_SIDED|90.0|-0.8375|-0.1395|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.1395|-0.8375|0.0233
71665977|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.0177|STANDARD_ERROR_OF_MEAN|0.2043||0.9314|TWO_SIDED|90.0|-0.3613|0.3259|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.3259|-0.3613|0.9314
71745876|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-43.3|36.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.6|-43.3|1.000
71779331|NCT02390908|143058429|SUPERIORITY||Beta|-0.86||||0.63|TWO_SIDED|95.0|-4.33|2.61||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 2 and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention at Site 2 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||2.61|-4.33|0.63
71834810|NCT05952076|143174121|OTHER||Adjusted mean difference|0.11||||0.6863|TWO_SIDED|95.0|-0.44|0.67|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ and baseline age (days). A random intercept for participant was included.|||0.67|-0.44|0.6863
71665978|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.0592|STANDARD_ERROR_OF_MEAN|0.2045||0.7734|TWO_SIDED|90.0|-0.4032|0.2847|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2847|-0.4032|0.7734
71665979|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.3796|STANDARD_ERROR_OF_MEAN|0.2043||0.0702|TWO_SIDED|90.0|-0.7232|-0.036|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0360|-0.7232|0.0702
71665980|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.0415|STANDARD_ERROR_OF_MEAN|0.1993||0.8359|TWO_SIDED|90.0|-0.3768|0.2937|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.2937|-0.3768|0.8359
71665981|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.3619|STANDARD_ERROR_OF_MEAN|0.1988||0.0759|TWO_SIDED|90.0|-0.6962|-0.0275|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||-0.0275|-0.6962|0.0759
71665982|NCT01009814|142846387|OTHER||Mean Difference (Net)|-0.3203|STANDARD_ERROR_OF_MEAN|0.1993||0.1155|TWO_SIDED|90.0|-0.6555|0.0149|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.||0.0149|-0.6555|0.1155
71665983|NCT03022084|142846447|NON_INFERIORITY|The probability that Desyncra is non-inferior to CBT, defined by the sponsor as the event that mean TQ score change from baseline in the Desyncra arm is no more than 3.5 points worse than the mean TQ change in the CBT arm.|||||||||||||Bayesian|Data collected to date were analyzed using a Bayesian approach.|||Data collected to date were analyzed using a Bayesian approach.|||
71665984|NCT03104400|142846448|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|34.5|||<|0.0001|TWO_SIDED|95.0|28.2|40.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||40.7|28.2|<0.0001
71665985|NCT03104400|142846448|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|42.3|||<|0.0001|TWO_SIDED|95.0|36.3|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|36.3|<0.0001
71745877|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|30.0||||0.217|TWO_SIDED|95.0|-2.9|62.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||62.9|-2.9|0.217
71665986|NCT03104400|142846449|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.28|||<|0.0001|TWO_SIDED|95.0|-0.35|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.35|<0.0001
71665987|NCT03104400|142846449|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.27|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.27|-0.40|<0.0001
71745878|NCT02365649|143002021|SUPERIORITY||Risk Difference (RD)|26.7||||0.603|TWO_SIDED|95.0|-16.5|69.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.9|-16.5|0.603
71745879|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||52.6|-27.6|0.686
71745880|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
71745881|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||27.4|-47.4|0.709
71745882|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|3.7||||1|TWO_SIDED|95.0|-16.6|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.1|-16.6|1.000
71745883|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|8.5||||0.428|TWO_SIDED|95.0|-6.1|23.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.0|-6.1|0.428
71745884|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|6.8||||0.639|TWO_SIDED|95.0|-9.3|22.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||22.9|-9.3|0.639
71745885|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|8.5||||0.583|TWO_SIDED|95.0|-22.2|39.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.2|-22.2|0.583
71745886|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|17.3||||0.171|TWO_SIDED|95.0|-7.2|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.9|-7.2|0.171
71745887|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
71779332|NCT02390908|143058429|SUPERIORITY||Beta|4.17||||0.02|TWO_SIDED|95.0|0.8|7.54||A latent growth curve (LGC) with an intercept and linear slope was specified. The intercept quoted here represents the difference between Site 3's Immediate Delivery Group and the Waitlist Group at the 3-month follow-up.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.|The main effect of receiving the PLUS intervention immediately at Site 3 on Alcohol Use severity (AUDIT) was estimated against Site 3's Waitlist Control Group.|||7.54|0.80|0.02
71834811|NCT05952076|143174122|OTHER||Adjusted mean difference|109.3||||0.5567|TWO_SIDED|95.0|-259.76|478.36|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline weight (grams) and baseline age (days). A random intercept for participant was included.|||478.36|-259.76|0.5567
71834812|NCT05952076|143174123|OTHER||Adjusted mean difference|0.1||||0.7275|TWO_SIDED|95.0|-0.46|0.66|||Mixed Models Analysis|See Estimation Comments|The mixed model included treatment and visit as factors, including the interaction term, and was adjusted by baseline WAZ, baseline age (days) and study intervention compliance. A random intercept for participant was included.|||0.66|-0.46|0.7275
71834813|NCT03144518|143174173|SUPERIORITY||Partial Eta Squared|0.079||||0.005|TWO_SIDED|90.0|0.014|0.173||ANCOVA, controlling for pre-intervention levels|ANCOVA|ANCOVA, controlling for pre-intervention levels||VAS-Valence Scores||.173|.014|.005
71745888|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71745889|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||13.0|-13.4|1.000
71745890|NCT02365649|143002022|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71745891|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
71745892|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
71745893|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
71745894|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|-6.3||||1|TWO_SIDED|95.0|-14.6|2.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.1|-14.6|1.000
71745895|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|2.6||||1|TWO_SIDED|95.0|-10.1|15.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.3|-10.1|1.000
71745896|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-11.8|16.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||16.7|-11.8|1.000
71779333|NCT02390908|143058429|SUPERIORITY||Slope|-0.4||||0.46|TWO_SIDED|95.0|-1.47|0.67||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 1 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.67|-1.47|0.46
71779334|NCT02390908|143058429|SUPERIORITY||Slope|-0.29||||0.5|TWO_SIDED|95.0|-1.12|0.55||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 2 relative to that for the Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.55|-1.12|0.50
71834814|NCT03144518|143174173|SUPERIORITY||Partial Eta-Squared|0.04||||0.047|TWO_SIDED|90.0|0.0|0.12|||ANCOVA|Controlling for pre-intervention scores||VAS-Arousal Scores||.120|.000|.047
71745897|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
71834815|NCT03144518|143174173|SUPERIORITY||Partial Eta Squared|0.096||||0.002|TWO_SIDED|90.0|0.022|0.196|||ANCOVA|Controlling for pre-intervention levels||Pictorial Scale||.196|.022|.002
71834816|NCT03144518|143174173|SUPERIORITY||Partial Eta Squared|0.002||||0.697|TWO_SIDED|90.0|0.0|0.036|||ANCOVA|Controlling for baseline levels||PANAS Positive Affect Scores||.036|.000|.697
71745898|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
71745899|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|4.3||||0.623|TWO_SIDED|95.0|-11.9|20.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||20.4|-11.9|0.623
71834817|NCT03144518|143174173|SUPERIORITY||Partial Eta Squared|0.005||||0.462|TWO_SIDED|90.0|0.0|0.053|||ANCOVA|||PANAS Negative Affect Scores||.053|.000|.462
71834818|NCT03144518|143174176|SUPERIORITY||Partial Eta Squared|0.001||||0.806|TWO_SIDED|90.0|0.0|0.031|||ANCOVA|Controlling for pre-intervention levels||||.031|.000|.806
71745900|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|1.000
71745901|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.7|-18.7|1.000
71745902|NCT02365649|143002023|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||3.1|-23.1|0.501
71745903|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|2.5||||1|TWO_SIDED|95.0|-23.9|28.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||28.9|-23.9|1.000
71745904|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|21.3||||0.204|TWO_SIDED|95.0|-5.0|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||47.5|-5.0|0.204
71745905|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|-10.0||||0.54|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||3.1|-23.1|0.540
71779335|NCT02390908|143058429|SUPERIORITY||Slope|-0.35||||0.43|TWO_SIDED|95.0|-1.23|0.52||A latent growth curve (LGC) with an intercept and linear slope was specified. The slope estimated here represents linear change in AUDIT across the 3-, 6-, 9- and 12-month follow-ups for Site 3 (Immediate) relative to Waitlist Control Group.|Latent Growth Curve|Analysis adjusted for gender and baseline value of the outcome.||||0.52|-1.23|0.43
71779336|NCT01781975|143058431|SUPERIORITY||ANCOVA|0.0616|STANDARD_ERROR_OF_MEAN|0.0364||0.048|TWO_SIDED|90.0|0.00176|0.121|||ANCOVA|||||0.121|0.00176|0.048
71745906|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|-3.1||||1|TWO_SIDED|95.0|-9.2|2.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||2.9|-9.2|1.000
71745907|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|5.7||||0.614|TWO_SIDED|95.0|-5.6|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||17.0|-5.6|0.614
71745908|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-9.1|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||11.5|-9.1|1.000
71745909|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|0.9||||1|TWO_SIDED|95.0|-15.0|16.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||16.8|-15.0|1.000
71745910|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|14.4||||0.135|TWO_SIDED|95.0|-2.5|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-2.5|0.135
71779337|NCT05280782|143058465|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Systolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Systolic Blood Pressure values were normal.|||
71779338|NCT05280782|143058465|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Diastolic Blood Pressure values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Diastolic Blood Pressure values were normal.|||
71779339|NCT05280782|143058466|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Heart Rate values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Heart Rate values were normal.|||
71745911|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-14.1|12.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||12.1|-14.1|1.000
71779340|NCT05280782|143058467|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Respiratory Rate values. The values were categorized as Normal or Abnormal.||||||0.016||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.016
71745912|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71834819|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.006||||0.438|TWO_SIDED|90.0|0.0|0.055|||ANCOVA|Controlling for Pre-Vaccination levels||4 Weeks A/Hong-Kong||.055|.000|.438
71745913|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|4.5||||1|TWO_SIDED|95.0|-11.3|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||20.3|-11.3|1.000
71779341|NCT05280782|143058468|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Temperature values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Temperature values were normal.|||
71779342|NCT05280782|143058469|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
71779343|NCT05280782|143058470|EQUIVALENCE|A McNemar test was performed between baseline and post-injection EKG. The outcomes were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the EKGs were normal.|||
71779344|NCT05280782|143058471|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Sodium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Sodium values were normal.|||
71779345|NCT05280782|143058471|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Potassium values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Potassium values were normal.|||
71779346|NCT05280782|143058471|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Chloride values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Chloride values were normal.|||
71779347|NCT05280782|143058471|EQUIVALENCE|A McNemar test was performed between baseline and post-injection CO2 values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
71779348|NCT05280782|143058472|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Glucose values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
71779349|NCT05280782|143058472|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Calcium values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
71779350|NCT05280782|143058472|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Creatinine values. The values were categorized as Normal or Abnormal.||||||0.453||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.453
71779351|NCT05280782|143058472|EQUIVALENCE|A McNemar test was performed between baseline and post-injection BUN values. The values were categorized as Normal or Abnormal.||||||0.125||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.125
71779352|NCT05280782|143058472|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Bilirubin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
71745914|NCT02365649|143002024|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||4.6|-14.6|1.000
71745915|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|15.0||||0.669|TWO_SIDED|95.0|-21.9|51.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||51.9|-21.9|0.669
71779353|NCT05280782|143058473|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Total Protein values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Total Protein values were normal.|||
71779354|NCT05280782|143058473|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Albumin values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
71834820|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.004||||0.516|TWO_SIDED|90.0|0.0|0.051|||ANCOVA|controlling for pre-vaccination levels||A/Hong-Kong 16 Weeks Post-Vaccination||.051|.000|.516
71834821|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.002||||0.671|TWO_SIDED|90.0|0.0|0.038|||ANCOVA|controlling for pre-vaccination levels||A/Michigan 4 weeks post-vaccination||.038|.000|.671
71779355|NCT05280782|143058474|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Alkaline Phosphatase values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Alkaline Phosphatase values were normal.|||
71779356|NCT05280782|143058474|EQUIVALENCE|A McNemar test was performed between baseline and post-injection ALT values. The values were categorized as Normal or Abnormal.||||||0.219||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.219
71779357|NCT05280782|143058474|EQUIVALENCE|A McNemar test was performed between baseline and post-injection AST values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the AST values were normal.|||
71779358|NCT05280782|143058475|EQUIVALENCE|A McNemar test was performed between baseline and post-injection WBC values. The values were categorized as Normal or Abnormal.||||||0.687||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.687
71779359|NCT05280782|143058476|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hemoglobin values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
71665988|NCT03104400|142846450|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.1|||<|0.0001|TWO_SIDED|95.0|24.7|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||37.5|24.7|<0.0001
71745916|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|15.0||||0.343|TWO_SIDED|95.0|-15.2|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||45.2|-15.2|0.343
71834822|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.0||||0.98|TWO_SIDED|90.0|0.0|0.0|||ANCOVA|Controlling for pre-vaccination levels||A/Michigan 16 weeks post-vaccination||.000|.000|.980
71745917|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||17.2|-57.2|0.442
71745918|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-23.4|32.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||32.2|-23.4|1.000
71745919|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|5.0||||0.601|TWO_SIDED|95.0|-13.6|23.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||23.5|-13.6|0.601
71745920|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|1.8||||1|TWO_SIDED|95.0|-18.2|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.7|-18.2|1.000
71779360|NCT05280782|143058477|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Hematocrit values. The values were categorized as Normal or Abnormal.||||||1||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||1.000
71745921|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|16.5||||0.301|TWO_SIDED|95.0|-14.5|47.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||47.5|-14.5|0.301
71745922|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||39.4|-10.3|0.256
71745923|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|1.5||||0.917|TWO_SIDED|95.0|-26.5|29.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.5|-26.5|0.917
71779361|NCT05280782|143058478|EQUIVALENCE|A McNemar test was performed between baseline and post-injection Platelets values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the Platelets values were normal.|||
71779362|NCT05280782|143058479|EQUIVALENCE|A McNemar test was performed between baseline and post-injection RBC values. The values were categorized as Normal or Abnormal.||||||0.375||||||The threshold for statistical significance was p = 0.05.|McNemar|||||||0.375
71834823|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.409|TWO_SIDED|90.0|0.0|0.057|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 4 weeks post-vaccination||.057|.000|.409
71834824|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.008||||0.377|TWO_SIDED|90.0|0.0|0.062|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 16 weeks post-vaccination||.062|.000|.377
71745924|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|-20.2||||1|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|1.000
71834825|NCT03144518|143174177|SUPERIORITY||Partial Eta Squared|0.0||||0.892|TWO_SIDED|90.0|0.0|0.008|||ANCOVA|Controlling for pre-vaccination levels||B/Phuket 4 weeks post-vaccination||.008|.000|.892
71834826|NCT03144518|143174177|SUPERIORITY|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.426|TWO_SIDED|90.0|0.0|0.058|||ANCOVA|Controlling for pre-vaccination levels||||.058|.000|.426
71745925|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|-5.7||||0.697|TWO_SIDED|95.0|-28.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||17.3|-28.8|0.697
71745926|NCT02365649|143002025|SUPERIORITY||Risk Difference (RD)|-20.0||||0.126|TWO_SIDED|95.0|-37.5|-2.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||-2.5|-37.5|0.126
71745927|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|10.0||||0.691|TWO_SIDED|95.0|-30.8|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.8|-30.8|0.691
71745928|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|28.8||||0.086|TWO_SIDED|95.0|-2.5|60.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||60.0|-2.5|0.086
71745929|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|-10.0||||0.702|TWO_SIDED|95.0|-45.6|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||25.6|-45.6|0.702
71745930|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|-12.5||||0.557|TWO_SIDED|95.0|-24.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||-1.0|-24.0|0.557
71745931|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
71745932|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||24.2|-14.4|0.707
71745933|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-27.9|28.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||28.8|-27.9|1.000
71745934|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|16.7||||0.175|TWO_SIDED|95.0|-7.2|40.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||40.6|-7.2|0.175
71745935|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|8.7||||0.517|TWO_SIDED|95.0|-18.0|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.4|-18.0|0.517
71745936|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
71834827|NCT01989455|143174185|SUPERIORITY_OR_OTHER||Percent ratio|73.19|||||TWO_SIDED|90.0|68.83|77.56||||||||77.56|68.83|
71834828|NCT00632203|143174187|SUPERIORITY_OR_OTHER|||||||0.6995|||||||2-sided Exact Pearson Chi-square Test|||||||0.6995
71834829|NCT02641912|143174194|SUPERIORITY_OR_OTHER||Least sqaure (LS) mean difference|0.63||||0.0084|TWO_SIDED|95.0|0.17|1.1|||ANOVA|From ANOVA model with factors for treatment and confirmed Sjögren's syndrome status stratification using Observed Margins option.|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|||1.10|0.17|0.0084
71834830|NCT00448669|143174226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Regression, Cox|||Safety analyses were performed in the intention-to-treat cohort. Primary safety end points included the frequency of adverse clinical or laboratory events.||||0.003
71745937|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
71745938|NCT02365649|143002026|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
71745939|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-41.0|41.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||41.0|-41.0|1.000
71745940|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||50.3|-12.8|0.257
71745941|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||15.9|-55.9|0.440
71745942|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-2.5||||1|TWO_SIDED|95.0|-24.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||19.3|-24.3|1.000
71745943|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.5|15.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.0|-16.5|1.000
71745944|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-20.0||||0.44|TWO_SIDED|95.0|-55.9|15.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||15.9|-55.9|0.440
71745945|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-28.7|31.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||31.4|-28.7|1.000
71779363|NCT05280782|143058480|EQUIVALENCE|A McNemar test was performed between baseline and post-injection MCV values. The values were categorized as Normal or Abnormal.|||||||||||||||||The McNemar test requires at least one participant for each outcome (Normal or Abnormal). Thus, no p-value was computed because all of the MCV values were normal.|||
71745946|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|10.5||||0.404|TWO_SIDED|95.0|-14.0|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||34.9|-14.0|0.404
71745947|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|2.5||||0.859|TWO_SIDED|95.0|-24.8|29.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||29.7|-24.8|0.859
71745948|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
71745949|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
71745950|NCT02365649|143002027|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
71779364|NCT02905149|143058493|SUPERIORITY||Median Difference (Final Values)|9.0|||<|0.05|TWO_SIDED|95.0|4.0|14.5||Not adjusted for multiple comparison|Wilcoxon (Mann-Whitney)||Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.|||14.5|4|< 0.05
71891079|NCT01307423|143304240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.4|0.0|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.0|-1.4|
71779365|NCT03285984|143058497|SUPERIORITY||Mean Difference (Net)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.27|-0.15||From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline|ANCOVA||Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment|||-0.15|-0.27|<.0001
71779366|NCT02761733|143058505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3652||||0.0679|TWO_SIDED|95.0|-6.9559|0.2255||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.2255|-6.9559|.0679
71779367|NCT02761733|143058505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.882||||0.0999|TWO_SIDED|95.0|-6.2957|0.5317||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||0.5317|-6.2957|.0999
71779368|NCT02761733|143058505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0139||||0.5588|TWO_SIDED|95.0|-4.4957|2.3779||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 148|||2.3779|-4.4957|.5588
71745951|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|10.0||||0.606|TWO_SIDED|95.0|-23.8|43.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||43.8|-23.8|0.606
71745952|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|35.0||||0.034|TWO_SIDED|95.0|5.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||64.1|5.9|0.034
71745953|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|-15.0||||0.532|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||0.6|-30.6|0.532
71745954|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|0.6||||1|TWO_SIDED|95.0|-20.5|21.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||21.8|-20.5|1.000
71745955|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|-0.6||||1|TWO_SIDED|95.0|-14.4|13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||13.3|-14.4|1.000
71745956|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-16.0|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||14.6|-16.0|1.000
71745957|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|12.1||||0.35|TWO_SIDED|95.0|-11.7|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.8|-11.7|0.350
71745958|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|21.7||||0.034|TWO_SIDED|95.0|2.0|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significant at the 0.5 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||41.3|2.0|0.034
71745959|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|1.2||||1|TWO_SIDED|95.0|-15.9|18.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||18.3|-15.9|1.000
71745960|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|1.000
71745961|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||14.6|-25.5|0.663
71745962|NCT02365649|143002028|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders||0.6|-30.6|0.251
71745963|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|15.0||||0.536|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.536
71745964|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|15.0||||0.238|TWO_SIDED|95.0|-0.6|30.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||30.6|-0.6|0.238
71745965|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-34.3|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||24.3|-34.3|1.000
71745966|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.0||||0.606|TWO_SIDED|95.0|-43.8|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||23.8|-43.8|0.606
71745967|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-3.8||||1|TWO_SIDED|95.0|-28.5|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||21.0|-28.5|1.000
71745968|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||9.2|-59.2|0.181
71745969|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
71745970|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
71745971|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||11.3|-61.3|0.231
71779369|NCT02761733|143058505|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2798||||0.8532|TWO_SIDED|95.0|-2.6771|3.2367||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 136|||3.2367|-2.6771|.8532
71779370|NCT02761733|143058506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4524||||0.0988|TWO_SIDED|95.0|-7.5302|0.6254||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 180|||0.6254|-7.5302|.0988
71779371|NCT02761733|143058506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3087||||0.876|TWO_SIDED|95.0|-4.1799|3.5625||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 166|||3.5625|-4.1799|.8760
71779372|NCT02761733|143058506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.541||||0.1878|TWO_SIDED|95.0|-1.2234|6.3054||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 153|||6.3054|-1.2234|.1878
71779373|NCT02761733|143058506|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6237||||0.333|TWO_SIDED|95.0|-4.9|1.6526||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 143|||1.6526|-4.9000|.3330
71779374|NCT02761733|143058507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9284||||0.6588|TWO_SIDED|95.0|-10.4728|6.616||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 175|||6.6160|-10.4728|.6588
71745972|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||69.2|5.8|0.099
71745973|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|31.3||||0.052|TWO_SIDED|95.0|2.2|60.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.3|2.2|0.052
71779375|NCT02761733|143058507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3959||||0.2633|TWO_SIDED|95.0|-2.2237|11.0155||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 169||a priori test||11.0155|-2.2237|.2633
71779376|NCT02761733|143058507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9703||||0.0343|TWO_SIDED|95.0|-17.2107|-0.7299||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 166|Satterthwaite adjusted df = 166|a priori test||-0.7299|-17.2107|.0343
71779377|NCT02761733|143058507|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7297||||0.3126|TWO_SIDED|95.0|-3.4864|10.9458||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis||Satterthwaite adjusted df = 163|a priori test||10.9458|-3.4864|.3126
71665989|NCT03104400|142846450|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|43.1|||<|0.0001|TWO_SIDED|95.0|36.7|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|36.7|<0.0001
71745974|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
71779378|NCT02761733|143058508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1241||||0.584|TWO_SIDED|95.0|-0.5675|0.3193||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 142|||.3193|-.5675|.5840
71665990|NCT03104400|142846451|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.3|||<|0.0001|TWO_SIDED|95.0|32.8|49.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.8|32.8|<0.0001
71745975|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|32.5||||0.194|TWO_SIDED|95.0|0.9|64.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||64.1|0.9|0.194
71745976|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||45.2|-17.7|0.400
71745977|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.9|32.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||32.9|-42.9|1.000
71745978|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|16.3||||0.477|TWO_SIDED|95.0|-18.6|51.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||51.1|-18.6|0.477
71779379|NCT02761733|143058508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2642||||0.2404|TWO_SIDED|95.0|-0.1754|0.7038||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 184|||.7038|-.1754|.2404
71745979|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-2.6||||0.833|TWO_SIDED|95.0|-26.4|21.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.3|-26.4|0.833
71745980|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-4.6||||0.732|TWO_SIDED|95.0|-30.9|21.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||21.7|-30.9|0.732
71745981|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|19.4||||0.468|TWO_SIDED|95.0|-15.4|54.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.2|-15.4|0.468
71745982|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-11.2||||0.339|TWO_SIDED|95.0|-34.1|11.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||11.7|-34.1|0.339
71745983|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-14.5||||0.263|TWO_SIDED|95.0|-39.3|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.3|0.263
71745984|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
71779380|NCT02761733|143058508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3192||||0.1074|TWO_SIDED|95.0|-0.0667|0.7051||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 129|||.7051|-.0667|.1074
71779381|NCT02761733|143058508|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0576||||0.7677|TWO_SIDED|95.0|-0.3238|0.439||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 131|||.4390|-.3238|.7677
71745985|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
71745986|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
71745987|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||37.1|-27.1|1.000
71745988|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|1.5||||0.891|TWO_SIDED|95.0|-19.6|22.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.6|-19.6|0.891
71745989|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-3.3||||0.779|TWO_SIDED|95.0|-25.8|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.3|-25.8|0.779
71745990|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
71745991|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
71779382|NCT02761733|143058509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.026||||0.9046|TWO_SIDED|95.0|-0.4507|0.3987||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 182|||.3987|-.4507|.9046
71779383|NCT02761733|143058509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2258||||0.2518|TWO_SIDED|95.0|-0.1591|0.6107||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173|||.6107|-.1591|.2518
71779384|NCT02761733|143058509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.437||||0.0338|TWO_SIDED|95.0|-0.837|-0.037||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165|||-.0370|-.8370|.0338
71745992|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
71745993|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|21.9||||0.083|TWO_SIDED|95.0|7.6|36.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||36.2|7.6|0.083
71745994|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|15.0||||0.151|TWO_SIDED|95.0|-2.1|32.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.0|-2.1|0.151
71745995|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-22.4|24.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||24.1|-22.4|1.000
71745996|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|0.4||||1|TWO_SIDED|95.0|-25.4|26.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||26.3|-25.4|1.000
71779385|NCT02761733|143058509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2564||||0.1555|TWO_SIDED|95.0|-0.6086|0.0958||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 157|||.0958|-.6086|.1555
71779386|NCT02761733|143058510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2967||||0.0283|TWO_SIDED|95.0|-0.5599|-0.0335||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 213|||-.0335|-.5599|.0283
71779387|NCT02761733|143058510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0401||||0.7407|TWO_SIDED|95.0|-0.1969|0.2771||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 194|||.2771|-.1969|.7407
71665991|NCT03104400|142846451|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|41.1|||<|0.0001|TWO_SIDED|95.0|32.5|49.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||49.6|32.5|<0.0001
71745997|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-9.2||||0.417|TWO_SIDED|95.0|-31.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.9|-31.3|0.417
71745998|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-20.2||||0.125|TWO_SIDED|95.0|-46.7|6.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||6.2|-46.7|0.125
71745999|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
71746000|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
71746001|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-18.3||||0.2|TWO_SIDED|95.0|-46.1|9.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||9.6|-46.1|0.200
71746002|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||50.8|-7.9|0.177
71746003|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|22.4||||0.074|TWO_SIDED|95.0|-1.4|46.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.2|-1.4|0.074
71746004|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
71746005|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|21.4||||0.177|TWO_SIDED|95.0|-7.9|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.8|-7.9|0.177
71746006|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|12.1||||0.343|TWO_SIDED|95.0|-12.7|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||36.8|-12.7|0.343
71746007|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||20.3|-36.1|0.585
71746008|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-30.0||||0.539|TWO_SIDED|95.0|-50.1|-9.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-9.9|-50.1|0.539
71746009|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-15.7||||0.277|TWO_SIDED|95.0|-40.8|9.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||9.3|-40.8|0.277
71746010|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-15.7||||0.422|TWO_SIDED|95.0|-42.9|11.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||11.5|-42.9|0.422
71779388|NCT02761733|143058510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2338||||0.0619|TWO_SIDED|95.0|-0.4778|0.0102||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 186|||.0102|-.4778|.0619
71746011|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
71746012|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
71746013|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||5.4|-41.1|0.364
71746014|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
71746015|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
71779389|NCT02761733|143058510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3793||||0.0009|TWO_SIDED|95.0|-0.599|-0.1596||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 172|||-.1596|-.5990|.0009
71779390|NCT02635776|143058546|SUPERIORITY||Risk Difference (RD)|63.2|||<|0.0001|TWO_SIDED|95.0|53.0|73.3|||Farrington-Manning test|||Treatment difference at 600 mg||73.3|53|<0.0001
71779391|NCT02635776|143058547|SUPERIORITY||Risk Difference (RD)|47.8|||<|0.0001|TWO_SIDED|95.0|38.0|57.7|||Farrington-Manning test|||Treatment difference at 1000 mg||57.7|38|<0.0001
71779392|NCT02635776|143058548|SUPERIORITY||Risk Difference (RD)|68.5|||<|0.0001|TWO_SIDED|95.0|58.6|78.5|||Farrington-Manning test|||Treatment difference at 300 mg||78.5|58.6|<0.0001
71779393|NCT02635776|143058549|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (using equally spaced scores), stratified by region (North America, Europe)||Treatment difference in maximum severity||||<0.0001
71891080|NCT01307423|143304241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.91|||||TWO_SIDED|95.0|-7.04|-2.78|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-2.78|-7.04|
71746016|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
71746017|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Clinical non-responders, Week 44||3.1|-23.1|1.000
71779394|NCT00660673|143058564|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in off time was assessed for significance using a 1-sample paired t test"||||<0.001
71779395|NCT00660673|143058564|OTHER|||||||0.433|||||||One-sample t-test|||"Change from Baseline to end of study in off time was assessed for significance using a 1-sample paired t-test."||||0.433
71779396|NCT00660673|143058565|OTHER||||||<|0.001|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t-test."||||<0.001
71779397|NCT00660673|143058565|OTHER|||||||0.15|||||||One-sample t-test|||"Change from Baseline to end of study in on time without troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.150
71779398|NCT00660673|143058566|OTHER|||||||0.725|||||||One-sample t-test|||"Change from initial LCIG infusion to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.725
71779399|NCT00660673|143058566|OTHER|||||||0.019|||||||One-sample t-test|||"Change from Baseline to end of study in on time with troublesome dyskinesia was assessed for significance using a 1-sample paired t test"||||0.019
71779400|NCT01903031|143058577|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
71779401|NCT01903031|143058577|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||<0.001
71891081|NCT01307423|143304241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.65|||||TWO_SIDED|95.0|-7.78|-3.51|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-3.51|-7.78|
71891082|NCT01307423|143304242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.67|-0.25|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.25|-0.67|<0.0001
71891083|NCT01307423|143304242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.32|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||-0.32|-0.74|<0.0001
71665992|NCT03104400|142846452|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.29||||0.0002|TWO_SIDED|95.0|-0.44|-0.14|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.14|-0.44|0.0002
71665993|NCT03104400|142846452|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.21||||0.0069|TWO_SIDED|95.0|-0.36|-0.06|||ANCOVA|ANCOVA model including treatment and the stratification factor current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.06|-0.36|0.0069
71665994|NCT03104400|142846453|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.8|29.8||Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Cochran-Mantel-Haenszel||Response Rate Difference = Upadacitinib - Placebo|||29.8|18.8|<0.0001
71665995|NCT03104400|142846453|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|33.1|||<|0.0001|TWO_SIDED|95.0|27.4|38.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||38.8|27.4|<0.0001
71665996|NCT03104400|142846454|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|21.3|||<|0.0001|TWO_SIDED|95.0|13.0|29.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.7|13.0|<0.0001
71665997|NCT03104400|142846454|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|25.3|||<|0.0001|TWO_SIDED|95.0|16.9|33.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.7|16.9|<0.0001
71746018|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-5.2||||0.606|TWO_SIDED|95.0|-21.2|10.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.8|-21.2|0.606
71746019|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-2.9||||1|TWO_SIDED|95.0|-21.7|16.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||16.0|-21.7|1.000
71746020|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
71779402|NCT01903031|143058578|OTHER||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.||||<0.001
71779403|NCT01903031|143058578|OTHER|||||||0.004||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.||||0.004
71677373|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.345|||||TWO_SIDED|95.0|1.772|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.772|
71746021|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
71779404|NCT03540030|143058598|OTHER|||||||0.297|||||||Wilcoxon (Mann-Whitney)|||||||.297
71779405|NCT03540030|143058599|OTHER|||||||0.005||||||At the 6 hour time point|Wilcoxon (Mann-Whitney)|||||||0.005
71779406|NCT03540030|143058599|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||At the 12 hour time point||||0.005
71779407|NCT03540030|143058600|OTHER|||||||0.0801|||||||Fisher Exact|||||||0.0801
71779408|NCT03540030|143058601|OTHER|||||||0.0154|||||||Chi-squared|||||||0.0154
71779409|NCT03540030|143058602|OTHER|||||||0.2139|||||||Fisher Exact|||||||0.2139
71779410|NCT03540030|143058604|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
71779411|NCT03540030|143058605|OTHER|||||||0.9669|||||||Wilcoxon (Mann-Whitney)|||||||0.9669
71779412|NCT03540030|143058606|OTHER|||||||0.9208|||||||Wilcoxon (Mann-Whitney)|||||||.9208
71779413|NCT03540030|143058607|OTHER|||||||0.6481|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.6481
71779414|NCT03540030|143058607|OTHER|||||||0.3911|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.3911
71779415|NCT03540030|143058608|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
71779416|NCT03540030|143058609|OTHER|||||||0.3177|||||||Fisher Exact|||||||0.3177
71891084|NCT01307423|143304243|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.12|||||TWO_SIDED|95.0|-0.63|2.87|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||2.87|-0.63|
71746022|NCT02365649|143002029|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
71746023|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|17.5||||0.633|TWO_SIDED|95.0|-13.0|48.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||48.0|-13.0|0.633
71746024|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|30.0||||0.0024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.0024
71746025|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-34.8|34.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||34.8|-34.8|1.000
71746026|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-39.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.8|-39.8|1.000
71746027|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
71746028|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||15.1|-55.1|0.384
71779417|NCT03540030|143058610|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
71779418|NCT03540030|143058611|OTHER|||||||0.2349|||||||Fisher Exact|||||||0.2349
71779419|NCT03540030|143058612|OTHER|||||||0.7892|||||||Wilcoxon (Mann-Whitney)|||||||0.7892
71779420|NCT03540030|143058613|OTHER|||||||0.2023|||||||Wilcoxon (Mann-Whitney)|||For PCS only||||0.2023
71779421|NCT03540030|143058613|OTHER|||||||0.2486|||||||Wilcoxon (Mann-Whitney)|||For MCS only||||0.2486
71779422|NCT00347360|143058632|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
71779423|NCT00347360|143058633|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.||||>0.1
71779424|NCT00806351|143058670|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
71779425|NCT00806351|143058671|SUPERIORITY_OR_OTHER||Risk Difference|-27.3|||||TWO_SIDED|95.0|-80.9|40.3||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||40.3|-80.9|
71779426|NCT00806351|143058672|SUPERIORITY_OR_OTHER||Risk Difference|-40.0|||||TWO_SIDED|95.0|-97.5|63.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||63.9|-97.5|
71779427|NCT00806351|143058673|SUPERIORITY_OR_OTHER||Risk Difference|-50.0|||||TWO_SIDED|95.0|-97.5|55.0||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||55.0|-97.5|
71891085|NCT01307423|143304243|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.55|||||TWO_SIDED|95.0|0.8|4.31|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||4.31|0.80|
71891086|NCT01307423|143304244|SUPERIORITY_OR_OTHER_LEGACY||LS Means Difference|1.97|||||TWO_SIDED|95.0|0.28|3.65|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||3.65|0.28|
71746029|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.281
71746030|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
71746031|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-35.0||||0.108|TWO_SIDED|95.0|-70.8|0.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||0.8|-70.8|0.108
71746032|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|12.5||||0.686|TWO_SIDED|95.0|-27.6|52.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||52.6|-27.6|0.686
71746033|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
71746034|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-10.0||||0.709|TWO_SIDED|95.0|-47.4|27.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||27.4|-47.4|0.709
71746035|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|37.5||||0.099|TWO_SIDED|95.0|5.8|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.2|5.8|0.099
71746036|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
71779428|NCT00806351|143058678|SUPERIORITY_OR_OTHER||Risk Difference|-36.4|||||TWO_SIDED|95.0|-90.6|31.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.||31.9|-90.6|
71779429|NCT02187744|143058684|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.02|6.49|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||6.49|-8.02|
71779430|NCT02187744|143058684|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough \>20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|95.0|-8.59|6.23|||||Unstratified analysis.|||6.23|-8.59|
71779431|NCT02187744|143058686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-16.58|10.96|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||10.96|-16.58|
71746037|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-38.0|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||38.0|-38.0|1.000
71746038|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|15.6||||0.465|TWO_SIDED|95.0|-19.5|50.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||50.7|-19.5|0.465
71746039|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|3.9||||0.745|TWO_SIDED|95.0|-19.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||27.0|-19.3|0.745
71779432|NCT02187744|143058686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|7.35|||TWO_SIDED|95.0|-17.4|11.4|||||Unstratified analysis.|||11.40|-17.40|
71779433|NCT02187744|143058687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|95.0|-4.01|15.94|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.|||15.94|-4.01|
71746040|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-8.3||||0.512|TWO_SIDED|95.0|-32.6|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||16.1|-32.6|0.512
71746041|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|22.5||||0.281|TWO_SIDED|95.0|-12.2|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||57.2|-12.2|0.281
71746042|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-8.1||||0.486|TWO_SIDED|95.0|-30.8|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||14.6|-30.8|0.486
71746043|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-15.8||||0.212|TWO_SIDED|95.0|-39.5|8.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||8.0|-39.5|0.212
71746044|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|11.9||||0.697|TWO_SIDED|95.0|-22.3|46.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||46.0|-22.3|0.697
71746045|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||19.9|-23.2|0.880
71746046|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||11.2|-32.7|0.355
71746047|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||39.9|-23.7|0.678
71746048|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|1.7||||0.873|TWO_SIDED|95.0|-18.6|21.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||21.9|-18.6|0.873
71746049|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-0.1||||0.99|TWO_SIDED|95.0|-22.3|22.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||22.0|-22.3|0.990
71779434|NCT02187744|143058687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-4.08|16.27|||||Unstratified analysis.|||16.27|-4.08|
71746050|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|8.1||||0.678|TWO_SIDED|95.0|-23.7|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||39.9|-23.7|0.678
71779435|NCT00134030|143058690|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.214|TWO_SIDED|95.0|0.61|1.12|||Log Rank|||||1.12|0.61|0.214
71746051|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|4.6||||0.663|TWO_SIDED|95.0|-16.0|25.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||25.2|-16.0|0.663
71746052|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-8.8||||0.494|TWO_SIDED|95.0|-28.7|11.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||11.0|-28.7|0.494
71746053|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|23.2||||0.169|TWO_SIDED|95.0|-1.6|48.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||48.1|-1.6|0.169
71779436|NCT00134030|143058690|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.86|TWO_SIDED|95.0|0.78|1.23|||Log Rank|||||1.23|0.78|0.86
71779437|NCT00134030|143058690|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.69|TWO_SIDED|95.0|-3.3|4.9|||Difference in RMST|||Secondary RMST analysis performed in poor response group, due to evidence of non-proportional hazards.||4.9|-3.3|0.69
71779438|NCT00134030|143058691|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.804|TWO_SIDED|95.0|0.69|1.33|||Log Rank|||||1.33|0.69|0.804
71779439|NCT00134030|143058691|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.674|TWO_SIDED|95.0|0.81|1.39|||Log Rank|||||1.39|0.81|0.674
71746054|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|30.6||||0.005|TWO_SIDED|95.0|11.5|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.7|11.5|0.005
71746055|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|0.7||||0.963|TWO_SIDED|95.0|-26.8|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||28.1|-26.8|0.963
71746056|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|6.7||||0.729|TWO_SIDED|95.0|-19.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||33.2|-19.8|0.729
71746057|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-2.9||||0.804|TWO_SIDED|95.0|-25.8|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-25.8|0.804
71746058|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-14.0||||0.306|TWO_SIDED|95.0|-41.1|13.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||13.1|-41.1|0.306
71746059|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|12.9||||0.497|TWO_SIDED|95.0|-14.1|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||40.0|-14.1|0.497
71746060|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-0.1||||0.993|TWO_SIDED|95.0|-24.0|23.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||23.8|-24.0|0.993
71746061|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||4.1|-51.2|0.101
71746062|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|7.1||||0.655|TWO_SIDED|95.0|-24.0|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.3|-24.0|0.655
71746063|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|15.5||||0.221|TWO_SIDED|95.0|-9.0|40.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||40.0|-9.0|0.221
71779440|NCT01435603|143058697|SUPERIORITY||Slope|-1.273||||0.017|TWO_SIDED||||||Regression, Linear|||||||0.017
71746064|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-7.9||||0.585|TWO_SIDED|95.0|-36.1|20.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||20.3|-36.1|0.585
71746065|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.9|-4.8|0.124
71746066|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||39.9|-9.5|0.234
71746067|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-4.8||||0.741|TWO_SIDED|95.0|-32.9|23.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||23.4|-32.9|0.741
71746068|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-25.0||||0.544|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||-6.0|-44.0|0.544
71779441|NCT00667875|143058706|SUPERIORITY|||||||0.49||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model, Group by time (4 time blocks) with an unstructured variance/covariance matrix. Baseline drinks per day was used as a covariate.||||0.49
71665998|NCT03104400|142846455|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|119.381|||<|0.0001|TWO_SIDED|95.0|97.987|147.942|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||147.942|97.987|<0.0001
71665999|NCT03104400|142846455|NON_INFERIORITY|"Non-inferiority of each upadacitinib dose versus adalimumab was assessed using Koch's 3-arm approach; non-inferiority was achieved if upadacitinib preserved at least 50% of the placebo-subtracted adalimumab effect.~The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path."|Percent Adalimumab Effect Preservation|146.604|||<|0.0001|TWO_SIDED|95.0|122.817|180.398|||Koch 3-Arm Test||The percent of adalimumab effect preservation is the point estimate of 3-arm non-inferiority analysis, which is calculated by (Upadacitinib - Placebo) / (Adalimumab - Placebo) \* 100.|||180.398|122.817|<0.0001
71746069|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-15.5||||0.238|TWO_SIDED|95.0|-38.2|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||7.3|-38.2|0.238
71746070|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-17.9||||0.364|TWO_SIDED|95.0|-41.1|5.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 20||5.4|-41.1|0.364
71746071|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-46.5|46.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||46.5|-46.5|1.000
71746072|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-10.7||||0.454|TWO_SIDED|95.0|-34.9|13.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||13.5|-34.9|0.454
71746073|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-25.0||||0.063|TWO_SIDED|95.0|-44.0|-6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 28||-6.0|-44.0|0.063
71746074|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||55.2|-35.2|0.544
71746075|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-5.5||||0.663|TWO_SIDED|95.0|-25.5|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||14.6|-25.5|0.663
71746076|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 36||0.6|-30.6|0.251
71779442|NCT00667875|143058707|SUPERIORITY|||||||0.03||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model (SPSS linear mixed) with an unstructured variance/covariance and baseline percent heavy drinking days as a covariate||||0.03
71779443|NCT00667875|143058708|SUPERIORITY|Anova across all three treatment groups|||||<|0.05|||||||ANOVA|Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2||||||<.05
71746077|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-14.6|4.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||4.6|-14.6|1.000
71746078|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-13.4|13.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||13.0|-13.4|1.000
71779444|NCT00667875|143058709|SUPERIORITY||||||<|0.05|||||||ANOVA|f 3.2 df 2||Anova across three groups||||<.05
71779445|NCT04680052|143058730|SUPERIORITY||Hazard Ratio (HR)|0.434|||<|0.0001|TWO_SIDED|95.0|0.324|0.58|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.580|0.324|<0.0001
71779446|NCT04680052|143058732|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.383|0.653|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.653|0.383|<0.0001
71834831|NCT00448669|143174227|SUPERIORITY_OR_OTHER_LEGACY||Efficacy|62.2||||0.03|TWO_SIDED|95.0|21.5|83.4|||Regression, Cox|||The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The primary hypothesis was that TDF-FTC, as compared with placebo, would reduce the rate of HIV infection by at least 65%, with a predefined lower boundary for the 95% confidence interval of 10%.||83.4|21.5|0.03
71834832|NCT00448669|143174228|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.004|TWO_SIDED|95.0|1.05|1.28|||Regression, Logistic|In this univariate model with the analysis of number of condomless sex acts, our model estimates the odds of reporting no condomless sex acts.||"A logistic regression was used to estimate the odds of reporting zero condomless sex acts. The longitudinal dependent variable (number of condomless sex acts) was defined as:~Number of condomless vaginal sexual acts with both casual and main partners among those who reported having had at least one sexual partner in the previous 30 days."||1.28|1.05|0.004
71666000|NCT03104400|142846456|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.67|||<|0.0001|TWO_SIDED|95.0|3.67|5.67|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.67|3.67|<0.0001
71746079|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|2.1||||1|TWO_SIDED|95.0|-14.4|18.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||18.7|-14.4|1.000
71779447|NCT04680052|143058733|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0286|TWO_SIDED|95.0|1.04|2.13|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.13|1.04|0.0286
71779448|NCT04680052|143058735|SUPERIORITY||Hazard Ratio (HR)|0.587||||0.1061|TWO_SIDED|95.0|0.306|1.128|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.128|0.306|0.1061
71779449|NCT04680052|143058736|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.0221|TWO_SIDED|95.0|1.06|2.03|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.03|1.06|0.0221
71779450|NCT04680052|143058737|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.4||||0.4093|TWO_SIDED|95.0|0.61|3.33|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.33|0.61|0.4093
71779451|NCT04680052|143058738|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.5||||0.2874|TWO_SIDED|95.0|0.69|3.47|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.47|0.69|0.2874
71779452|NCT04680052|143058739|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0014|TWO_SIDED|95.0|1.3|3.02|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.02|1.30|0.0014
71779453|NCT04680052|143058740|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.74|||Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.74|1.29|0.0009
71746080|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|1.000
71779454|NCT04680052|143058742|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.473|||<|0.0001|TWO_SIDED|95.0|0.33|0.678|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.678|0.330|<0.0001
71779455|NCT04680052|143058744|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.55||||0.0003|TWO_SIDED|95.0|0.397|0.763|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.763|0.397|0.0003
71779456|NCT04680052|143058746|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.85||||0.5837|TWO_SIDED|95.0|0.476|1.519|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||1.519|0.476|0.5837
71779457|NCT04680052|143058748|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.294|0.563|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.563|0.294|<0.0001
71779458|NCT04680052|143058750|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.481|||<|0.0001|TWO_SIDED|95.0|0.357|0.647|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.647|0.357|<0.0001
71834833|NCT00448669|143174229|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||Fisher Exact|||Fisher's Exact Test was performed to test for differences between the treatment groups in terms of adherence based on pill count.||||0.79
71746081|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||17.7|-18.7|1.000
71746082|NCT02365649|143002030|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 52||3.1|-23.1|0.501
71746083|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|30.0||||0.155|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.155
71746084|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|30.0||||0.024|TWO_SIDED|95.0|9.9|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||50.1|9.9|0.024
71746085|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-3.3||||1|TWO_SIDED|95.0|-40.1|33.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||33.4|-40.1|1.000
71746086|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-8.6||||0.633|TWO_SIDED|95.0|-46.4|29.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||29.2|-46.4|0.633
71746087|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|1.3||||1|TWO_SIDED|95.0|-24.7|27.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||27.2|-24.7|1.000
71746088|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-24.4||||0.209|TWO_SIDED|95.0|-61.3|12.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||12.5|-61.3|0.209
71746089|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|25.0||||0.283|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||44.0|6.0|0.283
71779459|NCT04680052|143058751|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.43|3.43|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||3.43|1.43|0.0003
71779460|NCT04680052|143058752|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Odds Ratio (OR)|2.0||||0.0005|TWO_SIDED|95.0|1.33|2.86|||stratified Cochran-Mantel-Haenszel||The strata information was based on the data obtained from the interactive response technology that was used for randomization.|||2.86|1.33|0.0005
71779461|NCT04680052|143058754|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|0.461|||<|0.0001|TWO_SIDED|95.0|0.312|0.681|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||0.681|0.312|<0.0001
71891087|NCT01307423|143304244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.72|||||TWO_SIDED|95.0|2.02|5.41|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||5.41|2.02|
71746090|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||28.5|-28.5|1.000
71746091|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-41.7||||0.048|TWO_SIDED|95.0|-77.8|-5.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-5.5|-77.8|0.048
71746092|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|21.4||||0.408|TWO_SIDED|95.0|-18.6|61.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||61.4|-18.6|0.408
71746093|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|25.0||||0.126|TWO_SIDED|95.0|-5.5|55.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||55.5|-5.5|0.126
71746094|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-16.7||||0.454|TWO_SIDED|95.0|-54.5|21.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||21.1|-54.5|0.454
71746095|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|35.7||||0.183|TWO_SIDED|95.0|1.8|69.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||69.7|1.8|0.183
71746096|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|18.8||||0.257|TWO_SIDED|95.0|-12.8|50.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||50.3|-12.8|0.257
71746097|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-44.7|33.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.6|-44.7|1.000
71746098|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|33.3||||0.307|TWO_SIDED|95.0|-9.7|76.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||76.3|-9.7|0.307
71746099|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|33.3||||0.172|TWO_SIDED|95.0|-4.1|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||70.8|-4.1|0.172
71746100|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||55.1|-40.9|1.000
71746101|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|13.3||||1|TWO_SIDED|95.0|-27.8|54.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||54.5|-27.8|1.000
71746102|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-11.7||||0.675|TWO_SIDED|95.0|-51.5|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.1|-51.5|0.675
71746103|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-12.9||||0.644|TWO_SIDED|95.0|-59.2|33.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||33.5|-59.2|0.644
71746104|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-50.6|1.000
71746105|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.0|-33.4|1.000
71746106|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||55.1|-40.9|1.000
71746107|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-50.6|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.6|-50.6|1.000
71779462|NCT04680052|143058756|SUPERIORITY|Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.|Hazard Ratio (HR)|1.192||||0.7469|TWO_SIDED|95.0|0.409|3.475|||stratified Log Rank||The hazard ratio was estimated using a stratified Cox proportional hazards model.|||3.475|0.409|0.7469
71779463|NCT00705289|143058799|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|0.1402||||0.0003|||||||Test for non-zero correlation|||Relationship between baseline DAS28 and age (prior to infliximab therapy)||||0.0003
71779464|NCT00705289|143058800|SUPERIORITY_OR_OTHER||Pearson Product Moment Correlation|-0.01||||0.7991||95.0|||||Test for non-zero correlation|||Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)||||0.7991
71779465|NCT00705289|143058801|SUPERIORITY_OR_OTHER|||||||0.7152||95.0|||||ANOVA|The association between Baseline DAS28 and gender is based on a one-way Anova.||Relationship between baseline DAS28 and gender (prior to infliximab therapy)||||0.7152
71666001|NCT03104400|142846456|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.72|||<|0.0001|TWO_SIDED|95.0|4.71|6.72|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.72|4.71|<0.0001
71666002|NCT03104400|142846457|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.4|4.7|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.7|2.4|<0.0001
71666003|NCT03104400|142846457|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|4.3|||<|0.0001|TWO_SIDED|95.0|3.1|5.5|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.5|3.1|<0.0001
71891088|NCT01307423|143304245|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.5|||||TWO_SIDED|95.0|10.5|28.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||28.6|10.5|
71891089|NCT01307423|143304245|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.2|||||TWO_SIDED|95.0|9.2|27.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||27.2|9.2|
71891090|NCT01307423|143304246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.6|||||TWO_SIDED|95.0|-10.6|-0.5|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.5|-10.6|
71666004|NCT03104400|142846458|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|5.6||||0.0815|TWO_SIDED|95.0|-0.6|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||11.8|-0.6|0.0815
71779466|NCT00705289|143058802|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.||Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)||||<0.0001
71779467|NCT00705289|143058803|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.15||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)||5.3|5.1|
71779468|NCT00705289|143058803|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.0|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)||5.5|5.0|
71779469|NCT00705289|143058803|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.2|STANDARD_DEVIATION|1.14||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)||5.3|5.1|
71779470|NCT00705289|143058803|SUPERIORITY_OR_OTHER||Mean Baseline DAS28 Raw Score|5.3|STANDARD_DEVIATION|1.16||||95.0|5.1|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)||5.5|5.1|
71779471|NCT03055156|143058804|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
71779472|NCT03055156|143058805|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71779473|NCT03055156|143058806|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71779474|NCT03055156|143058807|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71779475|NCT03055156|143058808|OTHER|||||||0.02|||||||t-test, 2 sided|||Analysis of Wake values||||0.02
71779476|NCT03055156|143058808|OTHER|||||||0.06|||||||t-test, 2 sided|||Analysis of REM values||||0.06
71779477|NCT03055156|143058808|OTHER|||||||0.83|||||||t-test, 2 sided|||Analysis of Non REM stage 1 values||||0.83
71779478|NCT03055156|143058808|OTHER|||||||0.87|||||||t-test, 2 sided|||Analysis of Non REM stage 2 values||||0.87
71779479|NCT03055156|143058808|OTHER|||||||0.97|||||||t-test, 2 sided|||Analysis of Non REM stage 3 values||||0.97
71779480|NCT03055156|143058809|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
71779481|NCT03055156|143058810|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
71779482|NCT03055156|143058812|OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
71779483|NCT03055156|143058813|OTHER|||||||0.86|||||||t-test, 2 sided|||analysis of 0-90 minutes||||0.86
71779484|NCT03055156|143058813|OTHER|||||||0.29|||||||t-test, 2 sided|||analysis of 90-180 minutes||||0.29
71779485|NCT03055156|143058813|OTHER|||||||0.58|||||||t-test, 2 sided|||analysis of 180-270 minutes||||0.58
71779486|NCT03055156|143058813|OTHER|||||||0.62|||||||t-test, 2 sided|||analysis of 270-360 min||||0.62
71779487|NCT03055156|143058814|OTHER|||||||0.389|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to compare the difference in core body temperature trend over time between the two study arms. Interaction between time and topper type on CBT was calculated.||||0.389
71779488|NCT03055156|143058814|OTHER|||||||0.01|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect over time from both study arms on CBT. Main effect of time on CBT.||||0.01
71779489|NCT03055156|143058814|OTHER|||||||0.642|||||||ANOVA|||Implemented two-way mixed ANOVA with time as within-subject variable and topper type as between-subject variable. This is to see the effect of the intervention on CBT including all time points. Main effect of topper type on CBT.||||0.642
71779490|NCT03055156|143058815|OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
71666005|NCT03104400|142846458|SUPERIORITY|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|13.5|||<|0.0001|TWO_SIDED|95.0|7.5|19.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Adalimumab|||19.4|7.5|<0.0001
71677374|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.485|||||TWO_SIDED|95.0|2.633|4.614||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.614|2.633|
71746108|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-33.4|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||50.0|-33.4|1.000
71746109|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|7.1||||1|TWO_SIDED|95.0|-40.9|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||55.1|-40.9|1.000
71746110|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-40.2|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||60.2|-40.2|1.000
71746111|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|18.3||||0.392|TWO_SIDED|95.0|-22.9|59.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||59.6|-22.9|0.392
71746112|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|2.9||||1|TWO_SIDED|95.0|-44.7|50.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||50.5|-44.7|1.000
71746113|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|29.0||||0.07|TWO_SIDED|95.0|6.5|51.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||51.5|6.5|0.070
71746114|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|29.5||||0.007|TWO_SIDED|95.0|9.8|49.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||49.2|9.8|0.007
71746115|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|3.3||||0.826|TWO_SIDED|95.0|-26.1|32.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||32.8|-26.1|0.826
71746116|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|0.3||||1|TWO_SIDED|95.0|-27.2|27.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||27.7|-27.2|1.000
71746117|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-5.2||||0.649|TWO_SIDED|95.0|-27.8|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||17.3|-27.8|0.649
71891091|NCT01307423|143304246|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.7|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||-0.7|-10.8|
71746118|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-16.7||||0.304|TWO_SIDED|95.0|-45.7|12.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||12.4|-45.7|0.304
71746119|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|10.3||||0.72|TWO_SIDED|95.0|-18.2|38.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||38.7|-18.2|0.720
71779491|NCT03055156|143058816|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71779492|NCT03055156|143058817|OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
71891092|NCT01307423|143304247|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.0|0.4|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.4|-1.0|
71891093|NCT01307423|143304247|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9|||||TWO_SIDED|95.0|-1.6|-0.2|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.2|-1.6|
71891094|NCT01307423|143304248|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|||||TWO_SIDED|95.0|-1.7|-0.3|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.3|-1.7|
71891095|NCT01307423|143304248|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.1|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||0.1|-1.4|
71891096|NCT01307423|143304249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.07|||||TWO_SIDED|95.0|-7.31|-2.84|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.84|-7.31|
71891097|NCT01307423|143304249|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.14|||||TWO_SIDED|95.0|-7.38|-2.89|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-2.89|-7.38|
71666006|NCT03104400|142846459|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.8|||<|0.0001|TWO_SIDED|95.0|25.7|47.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||47.9|25.7|<0.0001
71746120|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|1.2||||0.923|TWO_SIDED|95.0|-23.0|25.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||25.4|-23.0|0.923
71746121|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-20.0||||0.197|TWO_SIDED|95.0|-50.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||10.4|-50.4|0.197
71746122|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|11.5||||0.486|TWO_SIDED|95.0|-20.4|43.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||43.5|-20.4|0.486
71746123|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|17.9||||0.168|TWO_SIDED|95.0|-7.0|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||42.7|-7.0|0.168
71891098|NCT01307423|143304250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.23|||ANCOVA||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.23|-0.70|<0.0001
71746124|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|-3.3||||0.833|TWO_SIDED|95.0|-34.3|27.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||27.6|-34.3|0.833
71891099|NCT01307423|143304250|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46||||0.0001|TWO_SIDED|95.0|-0.69|-0.22|||ANCOVA||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||-0.22|-0.69|0.0001
71891100|NCT01307423|143304251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.12|||||TWO_SIDED|95.0|-0.68|2.93|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||2.93|-0.68|
71891101|NCT01307423|143304251|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.33|||||TWO_SIDED|95.0|0.52|4.15|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||4.15|0.52|
71891102|NCT01307423|143304252|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-10.2|15.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||15.5|-10.2|
71891103|NCT01307423|143304252|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.0|||||TWO_SIDED|95.0|4.2|29.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||29.8|4.2|
71746125|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|22.6||||0.173|TWO_SIDED|95.0|-8.2|53.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||53.4|-8.2|0.173
71891104|NCT01307423|143304253|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-7.8|20.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.4|-7.8|
71666007|NCT03104400|142846459|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.8|||<|0.0001|TWO_SIDED|95.0|28.8|50.9||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||50.9|28.8|<0.0001
71746126|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|17.6||||0.178|TWO_SIDED|95.0|-7.6|42.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||42.8|-7.6|0.178
71746127|NCT02365649|143002031|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-30.9|30.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANCOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||30.9|-30.9|1.000
71746128|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||16.3|-71.9|0.580
71746129|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-6.9||||1|TWO_SIDED|95.0|-53.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||39.7|-53.6|1.000
71746130|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||23.3|-72.2|0.580
71746131|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-38.9||||0.287|TWO_SIDED|95.0|-83.0|5.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||5.2|-83.0|0.287
71746132|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-5.6||||1|TWO_SIDED|95.0|-53.0|41.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||41.9|-53.0|1.000
71746133|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-15.6||||1|TWO_SIDED|95.0|-69.4|38.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||38.3|-69.4|1.000
71746134|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-27.8||||0.58|TWO_SIDED|95.0|-71.9|16.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||16.3|-71.9|0.580
71746135|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||53.0|-41.9|1.000
71746136|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-24.4||||0.58|TWO_SIDED|95.0|-72.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||23.3|-72.2|0.580
71746137|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-44.4||||0.103|TWO_SIDED|95.0|-76.9|-12.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-12.0|-76.9|0.103
71746138|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|5.6||||1|TWO_SIDED|95.0|-41.9|53.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||53.0|-41.9|1.000
71746139|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-4.4||||1|TWO_SIDED|95.0|-58.3|49.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||49.4|-58.3|1.000
71891105|NCT01307423|143304253|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-12.6|16.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||16.4|-12.6|
71666008|NCT03104400|142846460|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|0.0||||0.897|TWO_SIDED|95.0|-0.3|0.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||0.3|-0.3|0.8970
71666009|NCT03104400|142846460|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.5||||0.0028|TWO_SIDED|95.0|-0.7|-0.2||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.2|-0.7|0.0028
71677375|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.624|||||TWO_SIDED|95.0|1.817|3.789||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.789|1.817|
71746140|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-48.7|48.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||48.7|-48.7|1.000
71746141|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|16.7||||0.637|TWO_SIDED|95.0|-29.7|63.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||63.0|-29.7|0.637
71746142|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-60.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||33.3|-60.0|1.000
71746143|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||66.6|-29.4|0.570
71746144|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||10.2|-39.7|0.330
71746145|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-10.3||||1|TWO_SIDED|95.0|-40.0|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||19.4|-40.0|1.000
71746146|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|18.6||||0.57|TWO_SIDED|95.0|-29.4|66.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||66.6|-29.4|0.570
71746147|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-14.8||||0.33|TWO_SIDED|95.0|-39.7|10.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||10.2|-39.7|0.330
71746148|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||35.4|-33.8|1.000
71746149|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-1.4||||1|TWO_SIDED|95.0|-42.6|39.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||39.7|-42.6|1.000
71746150|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-21.4||||0.1|TWO_SIDED|95.0|-42.9|0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||0.1|-42.9|0.100
71891106|NCT01307423|143304254|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||||TWO_SIDED|95.0|6.4|25.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.8|6.4|
71666010|NCT03104400|142846461|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.08||||0.0162|TWO_SIDED|95.0|-0.15|-0.01||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.01|-0.15|0.0162
71746151|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|0.8||||1|TWO_SIDED|95.0|-33.8|35.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||35.4|-33.8|1.000
71746152|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|5.7||||1|TWO_SIDED|95.0|-33.8|45.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||45.3|-33.8|1.000
71746153|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-7.6||||0.598|TWO_SIDED|95.0|-29.9|14.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.6|-29.9|0.598
71891107|NCT01307423|143304254|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||||TWO_SIDED|95.0|9.6|29.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.1|9.6|
71746154|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-3.2||||1|TWO_SIDED|95.0|-30.7|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||24.3|-30.7|1.000
71746155|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|12.9||||0.468|TWO_SIDED|95.0|-24.7|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52|Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|50.4|-24.7|0.468
71746156|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|6.2||||1|TWO_SIDED|95.0|-15.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||28.1|-15.7|1.000
71746157|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|15.1||||0.538|TWO_SIDED|95.0|-15.2|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.4|-15.2|0.538
71746158|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-11.2||||0.692|TWO_SIDED|95.0|-48.0|25.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||25.6|-48.0|0.692
71746159|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||17.9|-46.9|0.388
71746160|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-19.0||||0.418|TWO_SIDED|95.0|-54.8|16.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||16.9|-54.8|0.418
71746161|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-17.1||||0.448|TWO_SIDED|95.0|-54.1|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||20.0|-54.1|0.448
71746162|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-13.7||||0.43|TWO_SIDED|95.0|-47.4|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||19.9|-47.4|0.430
71891108|NCT01307423|143304255|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-6.8|18.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||18.8|-6.8|
71891109|NCT01307423|143304255|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|18.0|||||TWO_SIDED|95.0|5.3|30.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||30.6|5.3|
71677376|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.096|||||TWO_SIDED|95.0|0.76|1.58||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.580|0.760|
71746163|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-42.8|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||37.6|-42.8|1.000
71746164|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-21.2||||0.406|TWO_SIDED|95.0|-55.3|12.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||12.9|-55.3|0.406
71746165|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-14.5||||0.388|TWO_SIDED|95.0|-46.9|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.9|0.388
71891110|NCT01307423|143304256|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.1|25.9|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||25.9|-2.1|
71746166|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-7.8||||1|TWO_SIDED|95.0|-46.5|30.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||30.8|-46.5|1.000
71746167|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-25.3||||0.204|TWO_SIDED|95.0|-54.7|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||4.1|-54.7|0.204
71746168|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-2.0||||0.907|TWO_SIDED|95.0|-34.9|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-34.9|0.907
71746169|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|-2.0||||1|TWO_SIDED|95.0|-40.2|36.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||36.3|-40.2|1.000
71746170|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|6.5||||1|TWO_SIDED|95.0|-28.4|41.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||41.3|-28.4|1.000
71746171|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|16.5||||0.45|TWO_SIDED|95.0|-15.5|48.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||48.4|-15.5|0.450
71746172|NCT02365649|143002032|SUPERIORITY||Risk Difference (RD)|9.8||||0.661|TWO_SIDED|95.0|-27.0|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.6|-27.0|0.661
71746173|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
71746174|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||70.8|-20.8|0.608
71746175|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
71891111|NCT01307423|143304256|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.3|||||TWO_SIDED|95.0|-9.2|19.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.8|-9.2|
71891112|NCT01307423|143304257|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|8.8|26.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||26.8|8.8|
71891113|NCT01307423|143304257|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.4|||||TWO_SIDED|95.0|2.7|20.0|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||20.0|2.7|
71891114|NCT01307423|143304258|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.9|||||TWO_SIDED|95.0|1.3|12.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.5|1.3|
71891115|NCT01307423|143304258|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|1.2|12.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.4|1.2|
71891116|NCT01307423|143304259|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9|||||TWO_SIDED|95.0|-0.4|6.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.2|-0.4|
71891117|NCT01307423|143304259|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-0.4|6.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||6.1|-0.4|
71891118|NCT01307423|143304260|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||||TWO_SIDED|95.0|3.2|16.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||16.3|3.2|
71746176|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||77.5|-77.5|1.000
71891119|NCT01307423|143304260|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.2|12.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution|||12.3|0.2|
71746177|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||49.0|-49.0|1.000
71746178|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-30.0||||0.565|TWO_SIDED|95.0|-79.3|19.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|ANOVA||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||19.3|-79.3|0.565
71746179|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||84.6|15.4|0.467
71746180|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||49.0|-49.0|1.000
71746181|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-15.4|-84.6|0.105
71746182|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||89.5|-64.5|1.000
71891120|NCT01307423|143304261|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.1|4.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.1|-4.1|
71891121|NCT01307423|143304261|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-3.7|4.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||4.8|-3.7|
71746183|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||60.7|-35.7|1.000
71746184|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
71891122|NCT01307423|143304262|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-8.1|12.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||12.6|-8.1|
71891123|NCT01307423|143304262|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|17.8|||||TWO_SIDED|95.0|6.3|29.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||29.3|6.3|
71891124|NCT01307423|143304263|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.4|||||TWO_SIDED|95.0|-4.8|23.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||23.5|-4.8|
71891125|NCT01307423|143304263|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1|||||TWO_SIDED|95.0|-7.2|21.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||21.5|-7.2|
71666011|NCT03104400|142846461|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.14|||<|0.0001|TWO_SIDED|95.0|-0.2|-0.07||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab|||-0.07|-0.20|<0.0001
71746185|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|50.0||||0.467|TWO_SIDED|95.0|15.4|84.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||84.6|15.4|0.467
71746186|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||60.7|-35.7|1.000
71746187|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||-15.4|-84.6|0.105
71746188|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
71746189|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||18.2|-28.2|1.000
71746190|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
71746191|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
71746192|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
71746193|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
71746194|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||72.9|-19.6|0.249
71746195|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||18.2|-28.2|1.000
71746196|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||24.6|-29.0|1.000
71746197|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|13.3||||0.613|TWO_SIDED|95.0|-35.1|61.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||61.8|-35.1|0.613
71746198|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-34.8|31.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||31.5|-34.8|1.000
71891126|NCT01307423|143304264|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-4.8|17.7|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||17.7|-4.8|
71666012|NCT03104400|142846462|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-17.1|||<|0.0001|TWO_SIDED|95.0|-19.6|-14.6||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-14.6|-19.6|<0.0001
71746199|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-15.6||||0.615|TWO_SIDED|95.0|-45.9|14.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||14.8|-45.9|0.615
71746200|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||67.5|-27.5|0.560
71746201|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-26.8|36.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared|||Non-responders, Week 52||36.8|-26.8|1.000
71746202|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||19.9|-37.7|1.000
71746203|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
71746204|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||46.1|-26.1|0.588
71746205|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
71746206|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|16.7||||0.631|TWO_SIDED|95.0|-29.9|63.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||63.2|-29.9|0.631
71746207|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|9.5||||0.597|TWO_SIDED|95.0|-25.7|44.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||44.8|-25.7|0.597
71746208|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-46.7|30.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||30.0|-46.7|1.000
71746209|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|26.7||||0.361|TWO_SIDED|95.0|-18.5|71.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||71.8|-18.5|0.361
71891127|NCT01307423|143304264|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|3.4|27.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||27.1|3.4|
71746210|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||31.0|-39.6|0.812
71746211|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-27.5||||0.345|TWO_SIDED|95.0|-61.3|6.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||6.3|-61.3|0.345
71891128|NCT01307423|143304265|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5|||||TWO_SIDED|95.0|-3.8|24.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||24.8|-3.8|
71891129|NCT01307423|143304265|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-9.5|19.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|||19.3|-9.5|
71746212|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||57.1|-37.1|1.000
71746213|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|10.0||||0.588|TWO_SIDED|95.0|-26.1|46.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||46.1|-26.1|0.588
71746214|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
71746215|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|20.0||||0.635|TWO_SIDED|95.0|-25.4|65.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||65.4|-25.4|0.635
71746216|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|10.5||||0.573|TWO_SIDED|95.0|-25.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||46.7|-25.7|0.573
71746217|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-34.2||||0.176|TWO_SIDED|95.0|-68.3|-0.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||-0.1|-68.3|0.176
71746218|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
71746219|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
71746220|NCT02365649|143002033|SUPERIORITY||Risk Difference (RD)|-12.5||||1|TWO_SIDED|95.0|-35.4|10.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical non-responders, Week 44||10.4|-35.4|1.000
71746221|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|1.000
71746222|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-32.5|57.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||57.5|-32.5|1.000
71746223|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||5.0|-55.0|0.487
71746224|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ|Non-respoonders||31.6|-9.4|0.375
71746225|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||3.9|-30.5|1.000
71746226|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|8.1||||0.651|TWO_SIDED|95.0|-19.4|35.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||35.6|-19.4|0.651
71746227|NCT02365649|143002034|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||27.8|-29.5|1.000
71666013|NCT03104400|142846462|OTHER|The overall type I error rate of the primary and the 14 ranked secondary endpoints was controlled using a two-part sequential graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-19.8|||<|0.0001|TWO_SIDED|95.0|-22.3|-17.3||This comparison was not tested for statistical significance because the hierarchical testing procedures stopped at ACR 20 at Week 12 superiority test of upadacitinib 15 mg versus adalimumab 40 mg.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-17.3|-22.3|<0.0001
71666014|NCT03104400|142846463|OTHER||Response Rate Difference|24.3|||<|0.0001|TWO_SIDED|95.0|18.7|29.9||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.7|<0.0001
71666015|NCT03104400|142846463|OTHER||Response Rate Difference|38.5|||<|0.0001|TWO_SIDED|95.0|32.8|44.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||44.3|32.8|<0.0001
71666016|NCT03104400|142846464|OTHER||Response Rate Difference|13.3|||<|0.0001|TWO_SIDED|95.0|9.5|17.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||17.0|9.5|<0.0001
71666017|NCT03104400|142846464|OTHER||Response Rate Difference|22.9|||<|0.0001|TWO_SIDED|95.0|18.5|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||27.3|18.5|<0.0001
71666018|NCT03104400|142846465|OTHER||Response Rate Difference|16.1|||<|0.0001|TWO_SIDED|95.0|10.9|21.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.4|10.9|<0.0001
71666019|NCT03104400|142846465|OTHER||Response Rate Difference|26.2|||<|0.0001|TWO_SIDED|95.0|20.7|31.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||31.8|20.7|<0.0001
71746228|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-77.5|77.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||77.5|-77.5|1.000
71746229|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-49.0|49.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||49.0|-49.0|1.000
71746230|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-50.0||||0.105|TWO_SIDED|95.0|-84.6|-15.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 20||-15.4|-84.6|0.105
71746231|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-64.5|89.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||89.5|-64.5|1.000
71746232|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-35.7|60.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||60.7|-35.7|1.000
71779493|NCT02130570|143058858|SUPERIORITY||Incidence rate ratio|0.52||||0.02|TWO_SIDED|95.0|0.3|0.91||This is the P-value for the adjusted IRR.|Regression poissant|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.91|0.30|0.02
71779494|NCT02130570|143058859|SUPERIORITY||Incidence rate ratio|0.78||||0.01|TWO_SIDED|95.0|0.64|0.95||This is the p-value for the adjusted rate|Regression poissant|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio|0.95|0.64|0.01
71779495|NCT02130570|143058860|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.64|1.85||This is the P-value for the adjusted Odds Ratio|Regression, Logistic|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect . OR: odds ratio|1.85|0.64|0.77
71666020|NCT01495702|142846497|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.|Difference in proportions|5.3||||0.066|TWO_SIDED|95.0|-0.5|12.0|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||12.0|-0.5|0.066
71666021|NCT04152863|142846501|SUPERIORITY||Mean Difference (Net)|11.9||||0.1812|TWO_SIDED|90.0|-9.5|32.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||32.5|-9.5|0.1812
71666022|NCT04152863|142846501|SUPERIORITY||Mean Difference (Net)|4.8||||0.3548|TWO_SIDED|90.0|-16.2|25.5|||Stratified Miettinen & Nurminen method|To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum.||||25.5|-16.2|0.3548
71666023|NCT04152863|142846501|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|7.1|||||TWO_SIDED|90.0|-14.6|28.2||||||||28.2|-14.6|
71666024|NCT04152863|142846502|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.5|2.27||||||||2.27|0.50|
71666025|NCT04152863|142846502|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.51|2.29||||||||2.29|0.51|
71746233|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 28||31.0|-66.0|1.000
71746234|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|62.5||||0.444|TWO_SIDED|95.0|29.0|96.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||96.0|29.0|0.444
71896186|NCT02495077|143314345|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.519|TWO_SIDED|95.0|-6.66|3.37|||Mixed Models Analysis|||Day 90. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 90 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 90. Random effects for the intercept and eGFR collection day were utilized in the model.||3.37|-6.66|0.519
71666026|NCT04152863|142846502|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.04||||||||2.04|0.50|
71666027|NCT04152863|142846504|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
71666028|NCT04152863|142846504|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in percentage|-2.1|||||TWO_SIDED|90.0|-23.1|19.2||||||||19.2|-23.1|
71666029|NCT04152863|142846504|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in %|0.0|||||TWO_SIDED|90.0|-21.2|21.2||||||||21.2|-21.2|
71666030|NCT04152863|142846505|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.7|3.02||||||||3.02|0.70|
71746235|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||72.4|-22.4|0.619
71746236|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-37.5||||0.231|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 36||-4.0|-71.0|0.231
71666031|NCT04152863|142846505|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.62|2.68||||||||2.68|0.62|
71666032|NCT04152863|142846505|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.6|2.22||||||||2.22|0.60|
71666033|NCT04152863|142846507|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.71|3.79||||||||3.79|0.71|
71746237|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-37.5||||1|TWO_SIDED|95.0|-71.0|-4.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||-4.0|-71.0|1.000
71666034|NCT04152863|142846507|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.68||||||||2.68|0.47|
71666035|NCT04152863|142846507|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.39|||||TWO_SIDED|95.0|0.64|3.02||||||||3.02|0.64|
71666036|NCT01644617|142846510|SUPERIORITY_OR_OTHER||Difference in Least Squares Means (LSM)|-3.62|||<|0.001|TWO_SIDED|95.0|-4.85|-2.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-2.39|-4.85|<0.001
71666037|NCT01644617|142846510|SUPERIORITY_OR_OTHER||Difference in LSM|-1.98||||0.003|TWO_SIDED|95.0|-3.24|-0.72|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.72|-3.24|0.003
71666038|NCT01644617|142846511|SUPERIORITY_OR_OTHER||Difference in LSM|-2.08|||<|0.001|TWO_SIDED|95.0|-3.14|-1.03|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.03|-3.14|<0.001
71666039|NCT01644617|142846511|SUPERIORITY_OR_OTHER||Difference in LSM|-1.23||||0.032||95.0|-2.36|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-2.36|0.032
71666040|NCT01644617|142846512|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.007|TWO_SIDED|95.0|-2.34|-0.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.39|-2.34|0.007
71666041|NCT01644617|142846512|SUPERIORITY_OR_OTHER||Difference in LSM|-0.54||||0.198|TWO_SIDED|95.0|-1.38|0.29|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.29|-1.38|0.198
71834834|NCT02638337|143174302|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.7|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||For the percentage of parabasal cells a mixed-effects model for repeated measures (MMRM) approach was used, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||-18.0|-25.7|<0.0001
71834835|NCT02638337|143174303|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.2|9.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||9.1|5.2|<0.0001
71834836|NCT02638337|143174304|SUPERIORITY||LS Mean Difference|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.59|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||||-0.59|-0.84|<0.0001
71834837|NCT02638337|143174305|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.62|3.06|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|For the MBS of vaginal dryness a generalized estimating equations (GEE) model was used to fit a marginal proportional odds model to the longitudinal ordered categorical data, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline severity of dryness modeled as a covariate.||3.06|1.62|<0.0001
71834838|NCT02638337|143174307|SUPERIORITY||LS Mean Difference|-21.6|||<|0.0001|TWO_SIDED|95.0|-25.2|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-18.0|-25.2|<0.0001
71834839|NCT02638337|143174307|SUPERIORITY||LS Mean Difference|-21.8|||<|0.0001|TWO_SIDED|95.0|-25.4|-18.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-18.1|-25.4|<0.0001
71834840|NCT02638337|143174308|SUPERIORITY||LS Mean Difference|5.8|||<|0.0001|TWO_SIDED|95.0|4.2|7.3|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||7.3|4.2|<0.0001
71666042|NCT01644617|142846513|SUPERIORITY_OR_OTHER||Difference in LSM|-4.84|||<|0.001|TWO_SIDED|95.0|-6.59|-3.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-3.09|-6.59|<0.001
71666043|NCT01644617|142846513|SUPERIORITY_OR_OTHER||Difference in LSM|-2.65||||0.003|TWO_SIDED|95.0|-4.35|-0.95|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.95|-4.35|0.003
71666044|NCT01644617|142846514|SUPERIORITY_OR_OTHER||Difference in LSM|-2.62|||<|0.001|TWO_SIDED|95.0|-4.12|-1.13|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-1.13|-4.12|<0.001
71666045|NCT01644617|142846514|SUPERIORITY_OR_OTHER||Difference in LSM|-1.37||||0.091|TWO_SIDED|95.0|-2.96|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-2.96|0.091
71666046|NCT01644617|142846515|SUPERIORITY_OR_OTHER||Difference in LSM|-1.97||||0.004|TWO_SIDED|95.0|-3.3|-0.64|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.64|-3.30|0.004
71666047|NCT01644617|142846515|SUPERIORITY_OR_OTHER||Difference in LSM|-0.83||||0.181|TWO_SIDED|95.0|-2.06|0.4|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.40|-2.06|0.181
71834841|NCT02638337|143174308|SUPERIORITY||LS Mean Difference|7.2|||<|0.0001|TWO_SIDED|95.0|5.5|9.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||9.0|5.5|<0.0001
71834842|NCT02638337|143174309|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.46|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4||-0.46|-0.69|<0.0001
71834843|NCT02638337|143174309|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.51|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8||-0.51|-0.75|<0.0001
71834844|NCT02638337|143174310|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0005|TWO_SIDED|95.0|1.27|2.36|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.36|1.27|0.0005
71666048|NCT01644617|142846516|SUPERIORITY_OR_OTHER||Difference in LSM|-1.27|||<|0.001|TWO_SIDED|95.0|-1.92|-0.62|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.62|-1.92|<0.001
71666049|NCT01644617|142846516|SUPERIORITY_OR_OTHER||Difference in LSM|-0.77||||0.023|TWO_SIDED|95.0|-1.43|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.11|-1.43|0.023
71666050|NCT01644617|142846517|SUPERIORITY_OR_OTHER||Difference in LSM|-0.53||||0.082|TWO_SIDED|95.0|-1.13|0.07|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.07|-1.13|0.082
71666051|NCT01644617|142846517|SUPERIORITY_OR_OTHER||Difference in LSM|-0.13||||0.691|TWO_SIDED|95.0|-0.79|0.52|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.52|-0.79|0.691
71666052|NCT01644617|142846518|SUPERIORITY_OR_OTHER||Difference in LSM|-0.61||||0.023|TWO_SIDED|95.0|-1.14|-0.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||-0.09|-1.14|0.023
71746238|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|25.0||||0.619|TWO_SIDED|95.0|-22.4|72.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||72.4|-22.4|0.619
71746239|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-17.5||||1|TWO_SIDED|95.0|-66.0|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 44||31.0|-66.0|1.000
71779496|NCT02130570|143058861|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|||||This is the P-value for the adjusted difference.|Regression, Linear|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect.|||0.91
71891130|NCT00190775|143304285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|STANDARD_ERROR_OF_MEAN|1.11|<|0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||<0.001
71746240|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|75.0||||0.133|TWO_SIDED|95.0|45.0|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||100.0|45.0|0.133
71746241|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|37.5||||0.315|TWO_SIDED|95.0|-7.5|82.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||82.5|-7.5|0.315
71666053|NCT01644617|142846518|SUPERIORITY_OR_OTHER||Difference in LSM|-0.34||||0.235|TWO_SIDED|95.0|-0.9|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.|||0.22|-0.90|0.235
71666054|NCT01644617|142846521|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.55|||<|0.001|TWO_SIDED|95.0|0.43|0.68|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.68|0.43|<0.001
71666055|NCT01644617|142846521|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.52|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.52|0.33|<0.001
71666056|NCT01644617|142846521|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.52|||<|0.001|TWO_SIDED|95.0|0.41|0.64|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.64|0.41|<0.001
71666057|NCT01644617|142846521|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.39|||<|0.001|TWO_SIDED|95.0|0.3|0.48|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.48|0.30|<0.001
71746242|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders, Week 52||5.0|-55.0|0.487
71666058|NCT01644617|142846522|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.13|<0.001
71666059|NCT01644617|142846522|SUPERIORITY_OR_OTHER||Difference in LSM: D. pteronyssinus|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.25|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.25|0.12|<0.001
71666060|NCT01644617|142846522|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.42|0.23|<0.001
71666061|NCT01644617|142846522|SUPERIORITY_OR_OTHER||Difference in LSM: D. farinae|0.25|||<|0.001|TWO_SIDED|95.0|0.16|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.|||0.33|0.16|<0.001
71666062|NCT01644617|142846523|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|12.4||||||95.0|-3.6|28.9|||||Analysis based on the Miettinen and Nurminen method|||28.9|-3.6|
71666063|NCT01644617|142846523|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|9.8|||||TWO_SIDED|95.0|-7.0|26.6|||||Analysis based on the Miettinen and Nurminen method|||26.6|-7.0|
71666064|NCT01644617|142846524|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-7.5|||||TWO_SIDED|95.0|-22.6|6.7|||||Analysis based on the Miettinen and Nurminen method|||6.7|-22.6|
71666065|NCT01644617|142846524|SUPERIORITY_OR_OTHER||Difference in Percentage Versus Placebo|-14.6|||||TWO_SIDED|95.0|-28.5|-5.4|||||Analysis based on the Miettinen and Nurminen method|||-5.4|-28.5|
71746243|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|26.7||||0.249|TWO_SIDED|95.0|-19.6|72.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||72.9|-19.6|0.249
71746244|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-13.3||||0.487|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.487
71746245|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-13.3||||0.511|TWO_SIDED|95.0|-30.5|3.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 20||3.9|-30.5|0.511
71891131|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.905
71891132|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.491
71666066|NCT02075515|142846525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjusted GMC Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09|||ANCOVA|||||1.09|0.86|
71666067|NCT02075515|142846525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\]|Adjustd GMC Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08|||ANCOVA|||||1.08|0.85|
71746246|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|33.3||||0.14|TWO_SIDED|95.0|-11.4|78.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||78.1|-11.4|0.140
71746247|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|10.0||||0.569|TWO_SIDED|95.0|-14.6|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||34.6|-14.6|0.569
71891133|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.600
71891134|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.052
71666068|NCT02075515|142846525|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within \[0.67, 1.5\].|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANCOVA|||||1.10|0.88|
71746248|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 28||28.5|-19.7|1.000
71666069|NCT01297985|142846535|SUPERIORITY||MIXREG Estimate|1.55|STANDARD_ERROR_OF_MEAN|0.62||0.013|TWO_SIDED||||||Mixed Effects Random Regression|||"This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime; and that intervention participants would report greater increases in hopefulness than controls, also maintained longitudinally~This first model reports on Recovery over time."||||.013
71666070|NCT01297985|142846536|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this first model included depressive symptoms as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes depressive symptoms as the moderator (High depressive symptoms X time X study condition)"||||0.01
71891135|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.514
71891136|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.515
71891137|NCT00190775|143304286|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.315
71891138|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
71834845|NCT02638337|143174310|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.47|2.74|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.74|1.47|<0.0001
71834846|NCT02638337|143174311|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6263|TWO_SIDED|95.0|0.55|1.43|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.43|0.55|0.6263
71834847|NCT02638337|143174311|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.66|1.75|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||1.75|0.66|0.7869
71834848|NCT02638337|143174311|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8894|TWO_SIDED|95.0|0.65|1.64|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.64|0.65|0.8894
71746249|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|13.3||||0.447|TWO_SIDED|95.0|-23.9|50.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||50.6|-23.9|0.447
71834849|NCT02638337|143174312|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8369|TWO_SIDED|95.0|0.4|2.1|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.10|0.40|0.8369
71834850|NCT02638337|143174312|SUPERIORITY||Odds Ratio (OR)|1.51||||0.397|TWO_SIDED|95.0|0.58|3.95|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||3.95|0.58|0.3970
71779497|NCT02130570|143058862|SUPERIORITY||Odds Ratio, log|0.85||||0.57|TWO_SIDED|95.0|0.47|1.51||"Please see the Other Statistical Analysis field for adjustments and the P-value computed for each survey question."|Regression, Logistic||"Please see the Other Statistical Analysis field for a list of the estimated value and 95% CI for each survey question."||"Please see the Other Statistical Analysis field for adjustments."|1.51|0.47|0.57
71779498|NCT03863197|143058876|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779499|NCT03863197|143058877|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779500|NCT03863197|143058878|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779501|NCT03863197|143058879|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779502|NCT03863197|143058880|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779503|NCT03863197|143058881|SUPERIORITY||||||<|0.01||||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779504|NCT03863197|143058885|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779505|NCT03863197|143058886|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||The α-level was adjusted to p ≤ 0.01 since multiple parameters were evaluated for most research questions, with a maximum of 5 parameters (functional strength)|Mixed Models Analysis|||||||<0.01
71779506|NCT05981391|143058887|SUPERIORITY|||||||0.01||||||Adjusted for multiple comparisons.|t-test, 2 sided|||||||0.01
71779507|NCT02498132|143058888|OTHER|A generalized estimating equation (GEE) model assuming a normal distribution, identity link function, and exchangeable correlation matrix was used to examine the interaction between time and treatment condition on BDI-II depressive symptoms adjusting for the main effects of baseline depressive symptoms, time, and treatment condition.|||||<|0.05|||||||Chi-squared|||||||<.05
71834851|NCT02638337|143174312|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5391|TWO_SIDED|95.0|0.54|3.26|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||3.26|0.54|0.5391
71834852|NCT02638337|143174313|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0095|TWO_SIDED|95.0|1.13|2.4|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||2.40|1.13|0.0095
71834853|NCT02638337|143174313|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0542|TWO_SIDED|95.0|0.99|2.11|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.11|0.99|0.0542
71834854|NCT02638337|143174313|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0004|TWO_SIDED|95.0|1.35|2.88|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||2.88|1.35|0.0004
71746250|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-19.3|6.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||6.0|-19.3|1.000
71746251|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|4.4||||1|TWO_SIDED|95.0|-19.7|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 36||28.5|-19.7|1.000
71746252|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|20.0||||0.56|TWO_SIDED|95.0|-27.5|67.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||67.5|-27.5|0.560
71746253|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-20.0||||0.231|TWO_SIDED|95.0|-40.2|0.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||0.2|-40.2|0.231
71746254|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-8.9||||1|TWO_SIDED|95.0|-37.7|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 44||19.9|-37.7|1.000
71746255|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|6.7||||1|TWO_SIDED|95.0|-32.4|45.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||45.7|-32.4|1.000
71746256|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-28.2|18.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||18.2|-28.2|1.000
71779508|NCT01065597|143058901|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||0.001
71779509|NCT01065597|143058902|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|This was a paired t-test.||||||>0.05
71779510|NCT01065597|143058904|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71779511|NCT00413244|143058905|SUPERIORITY_OR_OTHER|||||||0.03|||||||log mean|||"Statistician used all the time points post-baseline together (Overall). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline."||||0.03
71779512|NCT03993132|143058917|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.91|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.91|
71779513|NCT03993132|143058918|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|1.01|1.13|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.13|1.01|
71779514|NCT03993132|143058919|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.84|1.08|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.08|0.84|
71779515|NCT03993132|143058920|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.96|1.11|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.11|0.96|
71779516|NCT03993132|143058921|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.61|0.83|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.83|0.61|
71779517|NCT03993132|143058922|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.91|0.76|
71779518|NCT03993132|143058923|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
71891139|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.122
71746257|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-2.2||||1|TWO_SIDED|95.0|-29.0|24.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders, Week 52||24.6|-29.0|1.000
71746258|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|10.0||||1|TWO_SIDED|95.0|-37.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||57.1|-37.1|1.000
71746259|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-11.4||||0.7|TWO_SIDED|95.0|-45.7|22.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||22.8|-45.7|0.700
71834855|NCT02638337|143174314|SUPERIORITY||Odds Ratio (OR)|0.71||||0.4336|TWO_SIDED|95.0|0.3|1.67|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4||1.67|0.30|0.4336
71834856|NCT02638337|143174314|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7672|TWO_SIDED|95.0|0.37|2.08|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8||2.08|0.37|0.7672
71834857|NCT02638337|143174314|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7101|TWO_SIDED|95.0|0.39|1.89|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12||1.89|0.39|0.7101
71834858|NCT02638337|143174315|SUPERIORITY||LS Mean Difference|13.98|||<|0.0001|TWO_SIDED|95.0|11.85|16.12|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||16.12|11.85|<0.0001
71834859|NCT02638337|143174315|SUPERIORITY||LS Mean Difference|14.73|||<|0.0001|TWO_SIDED|95.0|12.5|16.96|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||16.96|12.50|<0.0001
71834860|NCT02638337|143174315|SUPERIORITY||LS Mean Difference|14.91|||<|0.0001|TWO_SIDED|95.0|12.55|17.28|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||17.28|12.55|<0.0001
71891140|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.931||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.931
71891141|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
71746260|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-40.0||||0.058|TWO_SIDED|95.0|-64.8|-15.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5). Prespecified statistical significance at the 0.1 level.|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 20||-15.2|-64.8|0.058
71834861|NCT02638337|143174316|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 4||||<0.0001
71834862|NCT02638337|143174316|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 8||||<0.0001
71834863|NCT02638337|143174316|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 12||||<0.0001
71834864|NCT02638337|143174317|SUPERIORITY||LS Mean Difference|2.5|||<|0.0001|TWO_SIDED|95.0|2.0|3.0|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||3.0|2.0|<0.0001
71834865|NCT02638337|143174317|SUPERIORITY||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|2.4|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||3.4|2.4|<0.0001
71834866|NCT02638337|143174317|SUPERIORITY||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|2.2|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.4|2.2|<0.0001
71834867|NCT02638337|143174318|SUPERIORITY||LS Mean Difference|-0.8||||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||-0.4|-1.3|0.0002
71834868|NCT02638337|143174318|SUPERIORITY||LS Mean Difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||-0.6|-1.5|<0.0001
71834869|NCT02638337|143174318|SUPERIORITY||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||-0.7|-1.6|<0.0001
71834870|NCT02638337|143174319|SUPERIORITY||LS Mean Difference|-1.0||||0.0118|TWO_SIDED|95.0|-1.8|-0.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.2|-1.8|0.0118
71834871|NCT02638337|143174320|SUPERIORITY||LS Mean Difference|0.02||||0.9748|TWO_SIDED|95.0|-1.17|1.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||1.20|-1.17|0.9748
71834872|NCT02638337|143174320|SUPERIORITY||LS Mean Difference|0.19||||0.7865|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||1.56|-1.18|0.7865
71891142|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.190
71891143|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
71746261|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||69.2|-22.5|0.354
71746262|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||50.4|-18.1|0.450
71746263|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-1.7||||1|TWO_SIDED|95.0|-39.1|35.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 28||35.8|-39.1|1.000
71746264|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||69.2|-22.5|0.354
71746265|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|9.0||||0.7|TWO_SIDED|95.0|-24.6|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||42.7|-24.6|0.700
71746266|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 36||17.9|-46.2|0.621
71746267|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-6.7||||1|TWO_SIDED|95.0|-51.8|38.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||38.5|-51.8|1.000
71746268|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-4.3||||0.812|TWO_SIDED|95.0|-39.6|31.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||31.0|-39.6|0.812
71746269|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-15.0||||0.657|TWO_SIDED|95.0|-53.9|23.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 44||23.9|-53.9|0.657
71746270|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|23.3||||0.354|TWO_SIDED|95.0|-22.5|69.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||69.2|-22.5|0.354
71746271|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|16.2||||0.45|TWO_SIDED|95.0|-18.1|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||50.4|-18.1|0.450
71746272|NCT02365649|143002035|SUPERIORITY||Risk Difference (RD)|-14.2||||0.621|TWO_SIDED|95.0|-46.2|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders, Week 52||17.9|-46.2|0.621
71746273|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20%of the cells have expected cell count \<5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||95.6|-62.2|1.000
71746274|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||79.6|-21.3|0.592
71779519|NCT03993132|143058924|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
71746275|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||38.2|-64.8|1.000
71834873|NCT02638337|143174320|SUPERIORITY||LS Mean Difference|1.59||||0.0392|TWO_SIDED|95.0|0.08|3.09|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||3.09|0.08|0.0392
71746276|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-80.0|80.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||80.0|-80.0|1.000
71746277|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||64.7|-39.7|1.000
71746278|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-30.0||||0.545|TWO_SIDED|95.0|-83.2|23.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||23.2|-83.2|0.545
71746279|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|50.0||||0.464|TWO_SIDED|95.0|10.0|90.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||90.0|10.0|0.464
71746280|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|12.5||||1|TWO_SIDED|95.0|-39.7|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||64.7|-39.7|1.000
71746281|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-50.0||||0.182|TWO_SIDED|95.0|-90.0|-10.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-10.0|-90.0|0.182
71746282|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||95.6|-62.2|1.000
71746283|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||79.6|-21.3|0.592
71746284|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-13.3||||1|TWO_SIDED|95.0|-64.8|38.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||38.2|-64.8|1.000
71746285|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|66.7||||0.429|TWO_SIDED|95.0|28.9|100.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||100.0|28.9|0.429
71746286|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|29.2||||0.592|TWO_SIDED|95.0|-21.3|79.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||79.6|-21.3|0.592
71746287|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-33.3||||0.455|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||4.4|-71.1|0.455
71746288|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|31.7||||0.191|TWO_SIDED|95.0|-14.0|77.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||77.4|-14.0|0.191
71746289|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||22.1|-22.1|1.000
71746290|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-8.3||||1|TWO_SIDED|95.0|-24.0|7.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||7.3|-24.0|1.000
71746291|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||71.2|-24.5|0.538
71746292|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-29.8|29.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||29.8|-29.8|1.000
71746293|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||27.0|-35.3|1.000
71746294|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||50.1|-26.7|0.515
71746295|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-22.1|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||22.1|-22.1|1.000
71746296|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||31.9|-23.6|1.000
71746297|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|23.3||||0.538|TWO_SIDED|95.0|-24.5|71.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||71.2|-24.5|0.538
71746298|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-16.7||||0.478|TWO_SIDED|95.0|-37.8|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||4.4|-37.8|0.478
71746299|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-4.2||||1|TWO_SIDED|95.0|-35.3|27.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||27.0|-35.3|1.000
71746300|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|11.7||||0.515|TWO_SIDED|95.0|-26.7|50.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.1|-26.7|0.515
71746301|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-17.9|34.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||34.6|-17.9|1.000
71746302|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|4.2||||1|TWO_SIDED|95.0|-23.6|31.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||31.9|-23.6|1.000
71779520|NCT03993132|143058925|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.88|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.88|
71779521|NCT03993132|143058926|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.91|0.96|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||0.96|0.91|
71779522|NCT03993132|143058927|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.18|0.83|
71834874|NCT02638337|143174321|SUPERIORITY||LS Mean Difference|0.16||||0.0752|TWO_SIDED|95.0|-0.02|0.34|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Desire||0.34|-0.02|0.0752
71891144|NCT00190775|143304287|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
71666071|NCT01297985|142846536|SUPERIORITY||MIXREG Estimate|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.01|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator||"We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes anxiety as the moderator (high anxiety X time X study condition)"||||0.01
71746303|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||71.9|-21.9|0.344
71746304|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|17.9||||0.429|TWO_SIDED|95.0|-17.8|53.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||53.5|-17.8|0.429
71746305|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 20||25.0|-46.4|1.000
71746306|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|8.3||||1|TWO_SIDED|95.0|-40.4|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||57.1|-40.4|1.000
71746307|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|8.3||||0.671|TWO_SIDED|95.0|-29.9|46.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||46.6|-29.9|0.671
71746308|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-13.1||||0.656|TWO_SIDED|95.0|-56.7|30.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 28||30.5|-56.7|0.656
71779523|NCT03993132|143058928|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.16|0.97|
71779524|NCT03993132|143058929|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.06|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.06|0.72|
71746309|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||64.7|-31.4|0.627
71746310|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|9.5||||0.701|TWO_SIDED|95.0|-27.7|46.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||46.7|-27.7|0.701
71746311|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-19.0||||0.603|TWO_SIDED|95.0|-56.2|18.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 36||18.1|-56.2|0.603
71779525|NCT03993132|143058930|OTHER|A Cox regression with selected variables based on previous literature, covariate data availability, examination of exposure group differences in the distribution of each covariate, and the association of covariates with the outcomes of interest was applied. The hazard ratio compare Empagliflozin versus Liraglutide (reference).|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.88|1.1|||||Hazard ratio compares empagliflozin versus liraglutide (reference).|||1.10|0.88|
71746312|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|16.7||||0.627|TWO_SIDED|95.0|-31.4|64.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||64.7|-31.4|0.627
71746313|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|2.4||||1|TWO_SIDED|95.0|-34.2|39.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||39.0|-34.2|1.000
71746314|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-4.8||||1|TWO_SIDED|95.0|-47.6|38.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 44||38.0|-47.6|1.000
71779526|NCT02805972|143058935|SUPERIORITY|"The null hypothesis is that there would be no difference across the Naloxone and placebo conditions.~The alternative hypothesis is that the cortisol value would be higher in the Naloxone condition than in the placebo condition."|Mean Difference (Final Values)|1.26||||0.067|TWO_SIDED|95.0|0.98|1.61||If the Winsorized value is excluded from analyses altogether, the P value is .012|t-test, 2 sided|Cortisol was log transformed for the statistical test, and the reported mean difference was exponentiated back to the original units of nmol/L below.||We compared cortisol values at 55 minutes, within person, across conditions. We Winsorized one participant's values for the placebo visit where values were between 2-4x above the 99th percentile value in the data and then log-transformed the data.||1.61|0.98|.067
71779527|NCT00788073|143059000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.05|||||||ANCOVA|||||||0.05
71779528|NCT00788073|143059001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.008||95.0|||||ANCOVA|||||||0.008
71779529|NCT02197273|143059046|SUPERIORITY_OR_OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.764
71891145|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
71746315|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|25.0||||0.344|TWO_SIDED|95.0|-21.9|71.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||71.9|-21.9|0.344
71746316|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|25.0||||0.248|TWO_SIDED|95.0|-10.9|60.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||60.9|-10.9|0.248
71746317|NCT02365649|143002036|SUPERIORITY||Risk Difference (RD)|-10.7||||1|TWO_SIDED|95.0|-46.4|25.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical Responders, Week 52||25.0|-46.4|1.000
71746318|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|1.000
71746319|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|25.0||||0.608|TWO_SIDED|95.0|-20.8|70.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||70.8|-20.8|0.608
71746320|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|-25.0||||0.487|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders||5.0|-55.0|0.487
71746321|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|20.0||||0.25|TWO_SIDED|95.0|-15.1|55.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||55.1|-15.1|0.250
71746322|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|8.3||||0.444|TWO_SIDED|95.0|-7.3|24.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||24.0|-7.3|0.444
71746323|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|11.1||||0.375|TWO_SIDED|95.0|-9.4|31.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders||31.6|-9.4|0.375
71746324|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|3.3||||1|TWO_SIDED|95.0|-31.1|37.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||37.8|-31.1|1.000
71779530|NCT02197273|143059047|SUPERIORITY_OR_OTHER|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||||||0.206
71779531|NCT02197273|143059048|SUPERIORITY_OR_OTHER||Fisher exact|0.486||||0.656|TWO_SIDED||||||Fisher Exact|||||||0.656
71779532|NCT01972568|143059057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.1208|TWO_SIDED|95.0|0.89|2.72|||Logistic regression model|||||2.72|0.89|0.1208
71779533|NCT01972568|143059065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.31||||0.0048|TWO_SIDED|95.0|1.44|7.61|||Logistic regression model|||||7.61|1.44|0.0048
71779534|NCT01972568|143059066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.0202|TWO_SIDED|95.0|1.11|3.46|||Logistic regression model|||||3.46|1.11|0.0202
71891146|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.705
71666072|NCT01297985|142846536|SUPERIORITY||MIXREG Estimate|0.03|STANDARD_ERROR_OF_MEAN|0.01||0.022|TWO_SIDED||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes general symptom distress as the moderator (high symptom distress X time X study condition)"||||.022
71666073|NCT01297985|142846537|SUPERIORITY||MIXREG Estimate|0.33|STANDARD_ERROR_OF_MEAN|0.012|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in Hopefulness that would be maintained longitudinally||||<.01
71666074|NCT01297985|142846538|SUPERIORITY||MIXREG Estimate|0.12|STANDARD_ERROR_OF_MEAN|0.04|<|0.01|TWO_SIDED||||||Mixed Effects Random Regression|||This analysis Mixed Effects Random Regression Modeling to test whether self-advocacy scores changed overtime by study condition status. Reported below are findings for the self-advocacy assertiveness sub scale.||||<0.01
71666075|NCT01297985|142846539|SUPERIORITY||MIXREG Estimate|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.017|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.017
71666076|NCT05044195|142846568|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: upper limit (UL) of the 95% confidence interval (CI) for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.802|||||TWO_SIDED|95.0|0.738|0.871||||||A/H1N1||0.871|0.738|
71666077|NCT05044195|142846568|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.9|||||TWO_SIDED|95.0|0.819|0.989||||||A/H3N2||0.989|0.819|
71666078|NCT05044195|142846568|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.944|||||TWO_SIDED|95.0|0.88|1.012||||||B/Yamagata||1.012|0.880|
71666079|NCT05044195|142846568|NON_INFERIORITY|Non-inferiority criteria for the GMT ratio: UL of the 95% CI for the inter-group GMT ratio is ≤1.5 for each vaccine strain|GMT ratio|0.992|||||TWO_SIDED|95.0|0.923|1.067||||||B/Victoria||1.067|0.923|
71746325|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|22.4||||0.215|TWO_SIDED|95.0|-8.0|52.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||52.8|-8.0|0.215
71746326|NCT02365649|143002037|SUPERIORITY||Risk Difference (RD)|-0.8||||1|TWO_SIDED|95.0|-29.5|27.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders||27.8|-29.5|1.000
71779535|NCT02572401|143059067|SUPERIORITY||Risk Ratio (RR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.21|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.21|.59|<.05
71779536|NCT02572401|143059067|SUPERIORITY||Risk Ratio (RR)|0.99|||<|0.05|TWO_SIDED|95.0|0.69|1.42|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.42|0.69|<.05
71666080|NCT05044195|142846569|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-4.4|||||TWO_SIDED|95.0|-7.97|-0.74||||||A/H1N1||-0.74|-7.97|
71666081|NCT05044195|142846569|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-1.8|||||TWO_SIDED|95.0|-6.14|2.48||||||A/H3N2||2.48|-6.14|
71834875|NCT02638337|143174321|SUPERIORITY||LS Mean Difference|0.2||||0.1867|TWO_SIDED|95.0|-0.1|0.49|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Arousal||0.49|-0.10|0.1867
71666082|NCT05044195|142846569|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-2.4|||||TWO_SIDED|95.0|-6.77|2.0||||||B/Yamagata||2.00|-6.77|
71666083|NCT05044195|142846569|NON_INFERIORITY|Non-inferiority criteria for the SCR difference: UL of the 95% CI for the difference in SCR is ≤10% for each vaccine strain|SCR difference|-3.9|||||TWO_SIDED|95.0|-8.31|0.45||||||B/Victoria||0.45|-8.31|
71666084|NCT05044195|142846570|SUPERIORITY||GMT ratio|0.808|||||TWO_SIDED|95.0|0.745|0.876||||||A/H1N1||0.876|0.745|
71666085|NCT05044195|142846570|SUPERIORITY||GMT ratio|0.91|||||TWO_SIDED|95.0|0.829|0.998||||||A/H3N2||0.998|0.829|
71666086|NCT05044195|142846570|SUPERIORITY||GMT ratio|0.947|||||TWO_SIDED|95.0|0.884|1.014||||||B/Yamagata||1.014|0.884|
71666087|NCT05044195|142846570|SUPERIORITY||GMT ratio|1.0|||||TWO_SIDED|95.0|0.931|1.075||||||B/Victoria||1.075|0.931|
71666088|NCT05044195|142846571|OTHER||GMT ratio|0.87|||||TWO_SIDED|95.0|0.803|0.944||||||A/H1N1||0.944|0.803|
71666089|NCT05044195|142846571|OTHER||GMT ratio|0.953|||||TWO_SIDED|95.0|0.88|1.032||||||A/H3N2||1.032|0.880|
71666090|NCT05044195|142846571|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.953|1.077||||||B/Yamagata||1.077|0.953|
71666091|NCT05044195|142846571|OTHER||GMT ratio|1.028|||||TWO_SIDED|95.0|0.963|1.098||||||B/Victoria||1.098|0.963|
71666092|NCT05044195|142846579|OTHER||GMT ratio|0.838|||||TWO_SIDED|95.0|0.751|0.936||||||A/H1N1 (50 to 59 years)||0.936|0.751|
71666093|NCT05044195|142846579|OTHER||GMT ratio|0.924|||||TWO_SIDED|95.0|0.821|1.04||||||A/H3N2 (50 to 59 years)||1.040|0.821|
71834876|NCT02638337|143174321|SUPERIORITY||LS Mean Difference|0.4||||0.0161|TWO_SIDED|95.0|0.07|0.73|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Lubrication||0.73|0.07|0.0161
71746327|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-15.0||||0.671|TWO_SIDED|95.0|-55.5|25.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||25.5|-55.5|0.671
71746328|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|10.0||||0.718|TWO_SIDED|95.0|-19.8|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||39.8|-19.8|0.718
71746329|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-15.0||||0.461|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||22.4|-52.4|0.461
71746330|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-50.0||||0.03|TWO_SIDED|95.0|-85.5|-14.5||Statistically significant at 0.05 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||-14.5|-85.5|0.030
71746331|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-12.5||||0.483|TWO_SIDED|95.0|-42.9|17.9|||Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||17.9|-42.9|0.483
71746332|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-15.0||||0.431|TWO_SIDED|95.0|-50.8|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||20.8|-50.8|0.431
71746333|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-31.1|41.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||41.1|-31.1|1.000
71746334|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-7.5||||0.635|TWO_SIDED|95.0|-38.6|23.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||23.6|-38.6|0.635
71746335|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-40.0||||0.056|TWO_SIDED|95.0|-74.8|-5.2||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||-5.2|-74.8|0.056
71746336|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-7.5||||1|TWO_SIDED|95.0|-47.5|32.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.5|-47.5|1.000
71746337|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|17.5||||0.296|TWO_SIDED|95.0|-14.7|49.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||49.7|-14.7|0.296
71746338|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-42.4|32.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||32.4|-42.4|1.000
71746339|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-5.0||||1|TWO_SIDED|95.0|-45.9|35.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||35.9|-45.9|1.000
71666094|NCT05044195|142846579|OTHER||GMT ratio|0.926|||||TWO_SIDED|95.0|0.845|1.015||||||B/Yamagata (50 to 59 years)||1.015|0.845|
71746340|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|13.8||||0.4|TWO_SIDED|95.0|-17.7|45.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||45.2|-17.7|0.400
71746341|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
71834877|NCT02638337|143174321|SUPERIORITY||LS Mean Difference|0.16||||0.34|TWO_SIDED|95.0|-0.16|0.48|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Orgasm||0.48|-0.16|0.3400
71779537|NCT02572401|143059067|SUPERIORITY||Risk Ratio (RR)|0.72|||<|0.05|TWO_SIDED|95.0|0.35|1.49|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.49|.35|<.05
71779538|NCT02572401|143059068|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.92|1.18|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.18|0.92|<.05
71779539|NCT02572401|143059068|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.9|1.16|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.16|0.90|<.05
71779540|NCT02572401|143059068|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.86|1.42|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.42|0.86|<.05
71779541|NCT02572401|143059069|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.89|1.24|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.24|0.89|<.05
71779542|NCT02572401|143059069|SUPERIORITY||Risk Ratio (RR)|1.1|||<|0.05|TWO_SIDED|95.0|0.94|1.3|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|The numerator is the treatment.|1.30|0.94|<.05
71779543|NCT02572401|143059069|SUPERIORITY||Risk Ratio (RR)|1.05|||<|0.05|TWO_SIDED|95.0|0.76|1.47|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||1.47|0.76|<.05
71779544|NCT02572401|143059070|SUPERIORITY||Risk Ratio (RR)|1.04|||<|0.05|TWO_SIDED|95.0|0.73|1.48|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||1.48|0.73|<.05
71779545|NCT02572401|143059070|SUPERIORITY||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.71|1.45|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||1.45|0.71|<.05
71779546|NCT02572401|143059070|SUPERIORITY||Risk Ratio (RR)|1.02|||<|0.05|TWO_SIDED|95.0|0.5|2.08|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||2.08|.50|<.05
71779547|NCT02572401|143059071|SUPERIORITY||Mean Difference (Final Values)|0.001|||<|0.05|TWO_SIDED|95.0|-0.078|0.08|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.||0.080|-0.078|<.05
71779548|NCT02572401|143059071|SUPERIORITY||Mean Difference (Final Values)|-0.003|||<|0.05|TWO_SIDED|95.0|-0.082|0.076|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.||0.076|-0.082|<.05
71834878|NCT02638337|143174321|SUPERIORITY||LS Mean Difference|0.16||||0.2195|TWO_SIDED|95.0|-0.1|0.41|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Satisfaction||0.41|-0.10|0.2195
71834879|NCT02638337|143174321|SUPERIORITY||LS Mean Difference|0.45||||0.0103|TWO_SIDED|95.0|0.11|0.8|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Pain||0.80|0.11|0.0103
71746342|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.6|-12.8|0.259
71746343|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.5||||0.31|TWO_SIDED|95.0|-30.6|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||9.7|-30.6|0.310
71746344|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-19.4||||0.097|TWO_SIDED|95.0|-38.8|-0.1||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||-0.1|-38.8|0.097
71746345|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|24.4||||0.181|TWO_SIDED|95.0|-8.5|57.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||57.2|-8.5|0.181
71746346|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|2.0||||0.826|TWO_SIDED|95.0|-15.9|20.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||20.0|-15.9|0.826
71746347|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||16.1|-21.2|1.000
71746348|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|14.4||||0.369|TWO_SIDED|95.0|-16.7|45.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||45.4|-16.7|0.369
71746349|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-0.9||||1|TWO_SIDED|95.0|-18.2|16.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.4|-18.2|1.000
71746350|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-2.6||||1|TWO_SIDED|95.0|-21.2|16.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||16.1|-21.2|1.000
71746351|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|11.3||||0.66|TWO_SIDED|95.0|-20.2|42.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||42.7|-20.2|0.660
71746352|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-1.1||||0.908|TWO_SIDED|95.0|-19.7|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||17.5|-19.7|0.908
71779549|NCT02572401|143059071|SUPERIORITY||Mean Difference (Final Values)|-0.009|||<|0.05|TWO_SIDED|95.0|-0.167|0.149|||Regression, Linear|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.||The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.||0.149|-0.167|<.05
71779550|NCT00306189|143059072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|5.76|8.24|||t-test, 2 sided|||||8.24|5.76|<0.0001
71779551|NCT00306189|143059072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.25|||<|0.0001||95.0|4.1|6.4|||t-test, 2 sided|||||6.4|4.1|<0.0001
71779552|NCT00306189|143059072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.27|||<|0.0001||95.0|5.06|7.49|||t-test, 2 sided|||||7.49|5.06|<0.0001
71834880|NCT02638337|143174322|SUPERIORITY||LS Mean Difference|0.1||||0.723|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4||0.6|-0.4|0.7230
71666095|NCT05044195|142846579|OTHER||GMT ratio|0.989|||||TWO_SIDED|95.0|0.901|1.087||||||B/Victoria (50 to 59 years)||1.087|0.901|
71834881|NCT02638337|143174322|SUPERIORITY||LS Mean Difference|0.4||||0.1104|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8||0.9|-0.1|0.1104
71834882|NCT02638337|143174322|SUPERIORITY||LS Mean Difference|0.3||||0.2448|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12||0.9|-0.2|0.2448
71666096|NCT05044195|142846579|OTHER||GMT ratio|0.767|||||TWO_SIDED|95.0|0.681|0.864||||||A/H1N1 (60 to 64 years)||0.864|0.681|
71746353|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.1||||0.446|TWO_SIDED|95.0|-27.8|7.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||7.7|-27.8|0.446
71746354|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|20.6||||0.135|TWO_SIDED|95.0|-9.5|50.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||50.8|-9.5|0.135
71746355|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|11.2||||0.306|TWO_SIDED|95.0|-5.7|28.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||28.1|-5.7|0.306
71746356|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|3.7||||0.686|TWO_SIDED|95.0|-13.4|20.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||20.7|-13.4|0.686
71746357|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||35.2|-25.4|0.754
71746358|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-7.7||||0.548|TWO_SIDED|95.0|-32.6|17.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||17.3|-32.6|0.548
71746359|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-22.5||||0.12|TWO_SIDED|95.0|-50.1|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||5.0|-50.1|0.120
71746360|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-13.4||||0.403|TWO_SIDED|95.0|-44.5|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.7|-44.5|0.403
71746361|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-8.0||||0.533|TWO_SIDED|95.0|-33.0|17.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||17.0|-33.0|0.533
71746362|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-8.9||||0.539|TWO_SIDED|95.0|-37.2|19.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||19.4|-37.2|0.539
71746363|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|4.9||||0.754|TWO_SIDED|95.0|-25.4|35.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||35.2|-25.4|0.754
71746364|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-14.5||||0.256|TWO_SIDED|95.0|-39.4|10.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||10.3|-39.4|0.256
71746365|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-27.8||||0.055|TWO_SIDED|95.0|-54.7|-0.8||Statistically significant at 0.1 level.|Chi-squared|P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||-0.8|-54.7|0.055
71746366|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|2.2||||0.887|TWO_SIDED|95.0|-28.8|33.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||33.2|-28.8|0.887
71834883|NCT02638337|143174323|SUPERIORITY||LS Mean Difference|-4388.3||||0.4263|TWO_SIDED|95.0|-15214.8|6438.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||6438.3|-15214.8|0.4263
71834884|NCT02638337|143174324|SUPERIORITY||LS Mean Difference|-0.049|||<|0.0001|TWO_SIDED|95.0|-0.071|-0.027|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.027|-0.071|<0.0001
71834885|NCT02638337|143174325|SUPERIORITY||LS Mean Difference|-0.14||||0.5159|TWO_SIDED|95.0|-0.58|0.29|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||0.29|-0.58|0.5159
71746367|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|14.5||||0.256|TWO_SIDED|95.0|-10.3|39.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.4|-10.3|0.256
71746368|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-9.0||||0.518|TWO_SIDED|95.0|-36.0|17.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||17.9|-36.0|0.518
71746369|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|6.3||||0.695|TWO_SIDED|95.0|-25.1|37.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||37.6|-25.1|0.695
71746370|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|11.4||||0.373|TWO_SIDED|95.0|-13.5|36.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||36.4|-13.5|0.373
71746371|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-6.9||||0.628|TWO_SIDED|95.0|-34.6|20.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||20.8|-34.6|0.628
71746372|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-15.0||||1|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|1.000
71746373|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||20.9|-22.4|1.000
71746374|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-15.0||||0.251|TWO_SIDED|95.0|-30.6|0.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||0.6|-30.6|0.251
71746375|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|1.000
71746376|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||17.7|-18.7|1.000
71746377|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||3.1|-23.1|0.501
71746378|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||22.1|-3.0|0.488
71834886|NCT02638337|143174326|SUPERIORITY||LS Mean Difference|-0.75||||0.0227|TWO_SIDED|95.0|-1.39|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-1.39|0.0227
71834887|NCT02638337|143174327|SUPERIORITY||LS Mean Difference|-0.22||||0.0003|TWO_SIDED|95.0|-0.34|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.10|-0.34|0.0003
71834888|NCT02638337|143174328|SUPERIORITY||LS Mean Difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.1|-4.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-4.3|-8.1|<0.0001
71834889|NCT02638337|143174329|SUPERIORITY||LS Mean Difference|-1.35||||0.0084|TWO_SIDED|95.0|-2.35|-0.35|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-0.35|-2.35|0.0084
71891147|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.686
71891148|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.618||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.618
71666097|NCT05044195|142846579|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.766|1.033||||||A/H3N2 (60 to 64 years)||1.033|0.766|
71666098|NCT05044195|142846579|OTHER||GMT ratio|0.974|||||TWO_SIDED|95.0|0.879|1.079||||||B/Yamagata (60 to 64 years)||1.079|0.879|
71891149|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.903
71891150|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
71891151|NCT00190775|143304288|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.403
71891152|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.941
71891153|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
71666099|NCT05044195|142846579|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.905|1.133||||||B/Victoria (60 to 64 years)||1.133|0.905|
71746379|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
71746380|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.0||||0.232|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.232
71891154|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.391
71891155|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.685
71891156|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.774||95.0||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.774
71666100|NCT05044195|142846580|OTHER||GMT ratio|0.844|||||TWO_SIDED|95.0|0.761|0.935||||||A/H1N1 (yes)||0.935|0.761|
71746381|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|-10.0||||0.501|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|0.501
71746382|NCT02365649|143002038|SUPERIORITY||Risk Difference (RD)|9.5||||0.488|TWO_SIDED|95.0|-3.0|22.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||22.1|-3.0|0.488
71746383|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|20.0||||0.295|TWO_SIDED|95.0|2.5|37.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||37.5|2.5|0.295
71891157|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.36||95.0||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.360
71666101|NCT05044195|142846580|OTHER||GMT ratio|1.01|||||TWO_SIDED|95.0|0.904|1.128||||||A/H3N2 (yes)||1.128|0.904|
71746384|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|13.8||||0.355|TWO_SIDED|95.0|-7.4|34.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||34.9|-7.4|0.355
71891158|NCT00190775|143304289|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
71891159|NCT00190775|143304290|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.617
71891160|NCT00190775|143304290|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.789
71891161|NCT00190775|143304290|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.670
71891162|NCT00190775|143304290|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.018
71891163|NCT00190775|143304290|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.405
71891164|NCT00190775|143304291|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.544
71891165|NCT00190775|143304291|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.494
71666102|NCT05044195|142846580|OTHER||GMT ratio|0.948|||||TWO_SIDED|95.0|0.883|1.016||||||B/Yamagata (yes)||1.016|0.883|
71666103|NCT05044195|142846580|OTHER||GMT ratio|0.997|||||TWO_SIDED|95.0|0.926|1.073||||||B/Victoria (yes)||1.073|0.926|
71666104|NCT05044195|142846580|OTHER||GMT ratio|0.772|||||TWO_SIDED|95.0|0.677|0.88||||||A/H1N1 (no)||0.880|0.677|
71666105|NCT05044195|142846580|OTHER||GMT ratio|0.801|||||TWO_SIDED|95.0|0.683|0.941||||||A/H3N2 (no)||0.941|0.683|
71666106|NCT05044195|142846580|OTHER||GMT ratio|0.945|||||TWO_SIDED|95.0|0.831|1.076||||||B/Yamagata (no)||1.076|0.831|
71666107|NCT05044195|142846580|OTHER||GMT ratio|1.007|||||TWO_SIDED|95.0|0.881|1.151||||||B/Victoria (no)||1.151|0.881|
71746385|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-20.0||||0.384|TWO_SIDED|95.0|-55.1|15.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 20||15.1|-55.1|0.384
71746386|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-22.5||||0.311|TWO_SIDED|95.0|-59.5|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||14.5|-59.5|0.311
71746387|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-16.3||||0.422|TWO_SIDED|95.0|-43.8|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||11.3|-43.8|0.422
71746388|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-25.0||||0.181|TWO_SIDED|95.0|-59.2|9.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 28||9.2|-59.2|0.181
71746389|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|25.0||||0.281|TWO_SIDED|95.0|6.0|44.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||44.0|6.0|0.281
71746390|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-28.5|28.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||28.5|-28.5|1.000
71746391|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-25.0||||0.231|TWO_SIDED|95.0|-61.3|11.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 36||11.3|-61.3|0.231
71746392|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|27.5||||0.214|TWO_SIDED|95.0|-3.9|58.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||58.9|-3.9|0.214
71779553|NCT00945893|143059073|NON_INFERIORITY_OR_EQUIVALENCE|The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.|Rate difference|0.0|||||TWO_SIDED|95.0|-6.0|1.9|||Score|||The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): Rate Difference ≥ 10%, HA (alternative): Rate Difference \< 10%||1.9|-6.0|
71779554|NCT00945893|143059074|SUPERIORITY_OR_OTHER||rate difference|2.5|||||TWO_SIDED|95.0|-8.8|7.7|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||7.7|-8.8|
71779555|NCT00945893|143059075|SUPERIORITY_OR_OTHER||rate difference|6.1|||||TWO_SIDED|95.0|-5.6|12.6|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).||12.6|-5.6|
71779556|NCT00945893|143059076|SUPERIORITY_OR_OTHER||rate difference|9.3|||||TWO_SIDED|95.0|-0.8|16.3|||score|||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||16.3|-0.8|
71746393|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|21.3||||0.277|TWO_SIDED|95.0|-7.5|50.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||50.0|-7.5|0.277
71779557|NCT00945893|143059077|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|10.0|||||TWO_SIDED|95.0|-4.1|22.8|||Score|||||22.8|-4.1|
71779558|NCT00945893|143059080|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|0.4|||||TWO_SIDED|95.0|-13.9|14.5|||Score|||||14.5|-13.9|
71834890|NCT02638337|143174330|SUPERIORITY||LS Mean Difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.92|-1.19|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-1.19|-2.92|<0.0001
71834891|NCT02638337|143174331|SUPERIORITY||LS Mean Difference|-5.26|||<|0.0001|TWO_SIDED|95.0|-7.64|-2.89|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||||-2.89|-7.64|<0.0001
71834892|NCT02638337|143174332|SUPERIORITY|||||||0.9575|||||||Welch's t-test|||||||0.9575
71834893|NCT02638337|143174333|SUPERIORITY|||||||0.8772|||||||Welch's t-test|||||||0.8772
71746394|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-20.0||||0.442|TWO_SIDED|95.0|-57.2|17.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 44||17.2|-57.2|0.442
71746395|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|20.0||||0.419|TWO_SIDED|95.0|-17.1|57.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||57.1|-17.1|0.419
71746396|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|20.0||||0.214|TWO_SIDED|95.0|-10.4|50.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||50.4|-10.4|0.214
71746397|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-15.0||||0.439|TWO_SIDED|95.0|-52.4|22.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Responders, Week 52||22.4|-52.4|0.439
71746398|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|23.1||||0.284|TWO_SIDED|95.0|-10.1|56.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||56.4|-10.1|0.284
71779559|NCT00945893|143059083|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|-0.5|||||TWO_SIDED|95.0|-14.7|11.8|||Score|||||11.8|-14.7|
71779560|NCT00945893|143059086|NON_INFERIORITY_OR_EQUIVALENCE|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|2.0|||||TWO_SIDED|95.0|-12.6|14.9|||Score|||||14.9|-12.6|
71779561|NCT00945893|143059095|SUPERIORITY_OR_OTHER||rate difference|5.8|||||TWO_SIDED|95.0|-7.7|13.8|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||13.8|-7.7|
71779562|NCT00945893|143059096|SUPERIORITY_OR_OTHER||rate difference|-6.0|||||TWO_SIDED|95.0|-23.5|5.3|||score|||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||5.3|-23.5|
71779563|NCT00945893|143059097|SUPERIORITY_OR_OTHER||rate difference|2.4|||||TWO_SIDED|95.0|-9.3|10.8|||score|||The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).||10.8|-9.3|
71779564|NCT00144391|143059119|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71779565|NCT06956170|143059148|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.1|2.78|||||Hazard ratio was estimated using an unstratified Cox Proportional Hazard model with treatment arm as an explanatory variable.|||2.78|0.10|
71779566|NCT02400333|143059177|SUPERIORITY_OR_OTHER||Geometric mean ratio|84.85|||||TWO_SIDED|90.0|76.77|93.78||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||93.78|76.77|
71779567|NCT02400333|143059177|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.61|||||TWO_SIDED|95.0|88.22|105.79||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||105.79|88.22|
71779568|NCT02400333|143059177|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.16|||||TWO_SIDED|95.0|85.59|99.25||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.25|85.59|
71779569|NCT02400333|143059177|SUPERIORITY_OR_OTHER||Geometric mean ratio|89.84|||||TWO_SIDED|95.0|82.03|98.39||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.39|82.03|
71779570|NCT02400333|143059177|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.45|||||TWO_SIDED|95.0|90.53|104.9||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||104.90|90.53|
71666108|NCT05044195|142846581|OTHER||GMT ratio|0.82|||||TWO_SIDED|95.0|0.752|0.894||||||A/H1N1 (Comorbidity Risk Score \<50)||0.894|0.752|
71779571|NCT02400333|143059177|SUPERIORITY_OR_OTHER||Geometric mean ratio|97.07|||||TWO_SIDED|95.0|90.83|103.74||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||103.74|90.83|
71779572|NCT02400333|143059178|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.04|||||TWO_SIDED|95.0|90.33|99.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.99|90.33|
71779573|NCT02400333|143059178|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.41|||||TWO_SIDED|95.0|89.94|101.21||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||101.21|89.94|
71779574|NCT02400333|143059178|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.66|||||TWO_SIDED|95.0|90.53|98.98||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.98|90.53|
71666109|NCT05044195|142846581|OTHER||GMT ratio|0.933|||||TWO_SIDED|95.0|0.846|1.029||||||A/H3N2 (Comorbidity Risk Score \<50)||1.029|0.846|
71666110|NCT05044195|142846581|OTHER||GMTratio|0.972|||||TWO_SIDED|95.0|0.904|1.046||||||B/Yamagata (Comorbidity Risk Score \<50)||1.046|0.904|
71666111|NCT05044195|142846581|OTHER||GMT ratio|1.013|||||TWO_SIDED|95.0|0.938|1.094||||||B/Victoria (Comorbidity Risk Score \<50)||1.094|0.938|
71666112|NCT05044195|142846581|OTHER||GMT ratio|0.706|||||TWO_SIDED|95.0|0.553|0.902||||||A/H1N1 (Comorbidity Risk Score ≥50)||0.902|0.553|
71666113|NCT05044195|142846581|OTHER||GMT ratio|0.734|||||TWO_SIDED|95.0|0.549|0.982||||||A/H3N2 (Comorbidity Risk Score ≥50)||0.982|0.549|
71666114|NCT05044195|142846581|OTHER||GMT ratio|0.773|||||TWO_SIDED|95.0|0.638|0.935||||||B/Yamagata (Comorbidity Risk Score ≥50)||0.935|0.638|
71666115|NCT05044195|142846581|OTHER||GMT ratio|0.905|||||TWO_SIDED|95.0|0.739|1.107||||||B/Victoria (Comorbidity Risk Score ≥50)||1.107|0.739|
71666116|NCT02585778|142846584|SUPERIORITY||LS Mean Difference|-47.8|||<|0.0001|TWO_SIDED|95.0|-60.7|-35.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-35.0|-60.7|<0.0001
71666117|NCT02585778|142846584|SUPERIORITY||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.4|-43.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-43.6|-54.4|<0.0001
71666118|NCT02585778|142846586|SUPERIORITY||LS Mean Difference|-50.6|||<|0.0001|TWO_SIDED|95.0|-63.4|-37.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.||-37.9|-63.4|<0.0001
71666119|NCT02585778|142846586|SUPERIORITY||LS Mean Difference|-51.6|||<|0.0001|TWO_SIDED|95.0|-56.9|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-46.4|-56.9|<0.0001
71666120|NCT02585778|142846587|SUPERIORITY||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-61.2|-35.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-35.5|-61.2|<0.0001
71666121|NCT02585778|142846587|SUPERIORITY||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-50.9|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-40.4|-50.9|<0.0001
71666122|NCT02585778|142846588|SUPERIORITY||LS Mean Difference|-44.8|||<|0.0001|TWO_SIDED|95.0|-56.9|-32.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.8|-56.9|<0.0001
71746399|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|0.2||||0.988|TWO_SIDED|95.0|-23.9|24.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||24.3|-23.9|0.988
71746400|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-12.1||||0.37|TWO_SIDED|95.0|-38.1|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 20||13.9|-38.1|0.370
71746401|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|25.6||||0.268|TWO_SIDED|95.0|-8.9|60.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||60.2|-8.9|0.268
71746402|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-5.0||||0.665|TWO_SIDED|95.0|-27.4|17.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||17.5|-27.4|0.665
71779575|NCT02400333|143059178|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.67|||||TWO_SIDED|95.0|90.94|98.56||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.56|90.94|
71666123|NCT02585778|142846588|SUPERIORITY||LS Mean Difference|-50.2|||<|0.0001|TWO_SIDED|95.0|-55.2|-45.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-45.3|-55.2|<0.0001
71666124|NCT02585778|142846589|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.9|-30.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-30.5|-54.9|<0.0001
71666125|NCT02585778|142846589|SUPERIORITY||LS Mean Difference|-44.1|||<|0.0001|TWO_SIDED|95.0|-49.0|-39.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-39.2|-49.0|<0.0001
71666126|NCT02585778|142846590|SUPERIORITY||LS Mean Difference|-42.7|||<|0.0001|TWO_SIDED|95.0|-54.2|-31.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-31.3|-54.2|<0.0001
71746403|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-3.9||||0.759|TWO_SIDED|95.0|-28.9|21.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 28||21.0|-28.9|0.759
71746404|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|21.9||||0.259|TWO_SIDED|95.0|-12.8|56.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||56.6|-12.8|0.259
71779576|NCT02400333|143059178|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.0|||||TWO_SIDED|95.0|91.87|100.33||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.33|91.87|
71834894|NCT02638337|143174334|SUPERIORITY|||||||0.0007|||||||Wilcoxon rank-sum test|||||||0.0007
71746405|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-1.7||||0.88|TWO_SIDED|95.0|-23.2|19.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||19.9|-23.2|0.880
71746406|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-10.7||||0.355|TWO_SIDED|95.0|-32.7|11.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 36||11.2|-32.7|0.355
71779577|NCT02400333|143059178|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.56|||||TWO_SIDED|95.0|93.08|100.17||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||100.17|93.08|
71779578|NCT02400333|143059179|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.96|||||TWO_SIDED|95.0|90.27|99.89||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||99.89|90.27|
71779579|NCT02400333|143059179|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.24|||||TWO_SIDED|95.0|89.81|100.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||100.99|89.81|
71779580|NCT02400333|143059179|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.4|||||TWO_SIDED|95.0|90.26|98.73||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||98.73|90.26|
71746407|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-27.1|37.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||37.1|-27.1|1.000
71746408|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|4.4||||0.688|TWO_SIDED|95.0|-17.0|25.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||25.9|-17.0|0.688
71779581|NCT02400333|143059179|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.82|||||TWO_SIDED|95.0|91.36|98.42||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.||98.42|91.36|
71779582|NCT02400333|143059179|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.71|||||TWO_SIDED|95.0|91.78|99.82||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.||99.82|91.78|
71779583|NCT02400333|143059179|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|95.0|93.26|99.87||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.||99.87|93.26|
71779584|NCT01332500|143059202|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan tablets|paired t-test 2-sided|||||||<0.001
71779585|NCT01332500|143059202|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||<0.001
71834895|NCT01340066|143174341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.92|ONE_SIDED|80.0|||||Chi-squared|||||||.92
71779586|NCT01332500|143059202|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.005
71779587|NCT01332500|143059202|SUPERIORITY_OR_OTHER|||||||0.336||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.336
71779588|NCT01332500|143059202|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||Other tablets|paired t-test 2-sided|||||||0.162
71834896|NCT02395978|143174348|SUPERIORITY|||||||0.393|||||||Kruskal-Wallis|||||||0.393
71834897|NCT03338816|143174393|SUPERIORITY||Rate ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.41||P=6.040E-09|Negative binomial regression model|||Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.||0.41|0.16|<0.0001
71834898|NCT04238247|143174406|SUPERIORITY||Odds Ratio (OR)|1.876119||||0.006|TWO_SIDED|95.0|1.193531|2.949084||The threshold for statistical significance was p = 0.05.|Regression, Logistic|We conducted logistic regression adjusted for randomization strata (recommended CRS and reason for eligibility).||We hypothesized the intervention group would have greater child passenger safety guideline adherence at 6 months compared with enhanced usual care group. In planning the trial, we assumed 75% of TCBD caregivers would be re-randomized. Baseline randomization was stratified by recommended CRS (rear-facing seat, forward-facing seat, booster seat) and reason for eligibility (not using the recommended CRS at baseline or planning a premature transition in the next 6 months).||2.949084|1.193531|0.006
71746409|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|1.1||||0.927|TWO_SIDED|95.0|-22.3|24.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 44||24.5|-22.3|0.927
71746410|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|27.5||||0.075|TWO_SIDED|95.0|-5.0|60.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||60.0|-5.0|0.075
71746411|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|14.0||||0.154|TWO_SIDED|95.0|-4.8|32.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||32.7|-4.8|0.154
71746412|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|4.9||||0.707|TWO_SIDED|95.0|-14.4|24.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Non-responders, Week 52||24.2|-14.4|0.707
71746413|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|25.0||||0.085|TWO_SIDED|95.0|10.0|40.0||Statistically significant at 0.1 level. P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||40.0|10.0|0.085
71746414|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|14.7||||0.137|TWO_SIDED|95.0|-4.0|33.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||33.3|-4.0|0.137
71746415|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-11.8||||0.37|TWO_SIDED|95.0|-38.2|14.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 20||14.5|-38.2|0.370
71746416|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-3.6||||1|TWO_SIDED|95.0|-31.6|24.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||24.4|-31.6|1.000
71746417|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-16.4||||0.174|TWO_SIDED|95.0|-39.8|7.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||7.0|-39.8|0.174
71746418|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-17.1||||0.203|TWO_SIDED|95.0|-43.9|9.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 28||9.7|-43.9|0.203
71746419|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|20.1||||0.286|TWO_SIDED|95.0|-4.5|44.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||44.7|-4.5|0.286
71746420|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-3.6||||0.773|TWO_SIDED|95.0|-27.7|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||20.6|-27.7|0.773
71746421|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-23.5||||0.101|TWO_SIDED|95.0|-51.2|4.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 36||4.1|-51.2|0.101
71746422|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|15.2||||0.332|TWO_SIDED|95.0|-14.1|44.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||44.4|-14.1|0.332
71746423|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|16.2||||0.189|TWO_SIDED|95.0|-7.5|39.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||39.8|-7.5|0.189
71779589|NCT01332500|143059203|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
71779590|NCT01332500|143059203|SUPERIORITY_OR_OTHER|||||||0.349||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.349
71746424|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-14.1||||0.329|TWO_SIDED|95.0|-42.2|13.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 44||13.9|-42.2|0.329
71746425|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|24.6||||0.124|TWO_SIDED|95.0|-4.8|53.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||53.9|-4.8|0.124
71746426|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|15.2||||0.234|TWO_SIDED|95.0|-9.5|39.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||39.9|-9.5|0.234
71746427|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-10.0||||0.484|TWO_SIDED|95.0|-37.8|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical responders, Week 52||17.7|-37.8|0.484
71746428|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-57.3|37.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||37.3|-57.3|1.000
71746429|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-11.2||||0.431|TWO_SIDED|95.0|-38.9|16.5||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||16.5|-38.9|0.431
71746430|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-20.7||||0.25|TWO_SIDED|95.0|-48.5|7.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 20||7.1|-48.5|0.250
71746431|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|5.0||||1|TWO_SIDED|95.0|-40.9|50.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||50.9|-40.9|1.000
71746432|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-1.0||||1|TWO_SIDED|95.0|-25.2|23.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||23.3|-25.2|1.000
71746433|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-5.7||||1|TWO_SIDED|95.0|-31.1|19.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 28||19.6|-31.1|1.000
71746434|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|10.0||||0.544|TWO_SIDED|95.0|-35.2|55.2||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||55.2|-35.2|0.544
71746435|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-0.7||||1|TWO_SIDED|95.0|-22.4|20.9||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||20.9|-22.4|1.000
71779591|NCT01332500|143059203|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.208
71779592|NCT01332500|143059203|SUPERIORITY_OR_OTHER|||||||0.239||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.239
71779593|NCT01332500|143059203|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.583
71779594|NCT01332500|143059203|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total heath plan costs|paired t-test 2-sided|||||||<0.001
71779595|NCT01332500|143059204|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
71779596|NCT01332500|143059204|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||Non-steroidal, anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.177
71779597|NCT01332500|143059204|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.173
71779598|NCT01332500|143059204|SUPERIORITY_OR_OTHER|||||||0.191||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.191
71779599|NCT01332500|143059204|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.254
71779600|NCT01332500|143059204|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||<0.001
71779601|NCT01332500|143059205|SUPERIORITY_OR_OTHER|||||||0.866||95.0||||Triptan tablets|paired t-test 2-sided|||||||0.866
71779602|NCT01332500|143059205|SUPERIORITY_OR_OTHER|||||||0.094||95.0||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided|||||||0.094
71666127|NCT02585778|142846590|SUPERIORITY||LS Mean Difference|-38.7|||<|0.0001|TWO_SIDED|95.0|-43.4|-33.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-33.9|-43.4|<0.0001
71666128|NCT02585778|142846591|SUPERIORITY||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-49.4|-28.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-28.7|-49.4|<0.0001
71666129|NCT02585778|142846591|SUPERIORITY||LS Mean Difference|-36.7|||<|0.0001|TWO_SIDED|95.0|-40.9|-32.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-32.5|-40.9|<0.0001
71666130|NCT02585778|142846592|SUPERIORITY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|95.0|-37.8|-20.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-20.7|-37.8|<0.0001
71666131|NCT02585778|142846592|SUPERIORITY||LS Mean Difference|-27.6|||<|0.0001|TWO_SIDED|95.0|-31.2|-24.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-24.1|-31.2|<0.0001
71666132|NCT02585778|142846593|SUPERIORITY||Odds Ratio (OR)|117.0|||<|0.0001|TWO_SIDED|95.0|13.1|1041.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||1041.8|13.1|<0.0001
71666133|NCT02585778|142846593|SUPERIORITY||Odds Ratio (OR)|84.6|||<|0.0001|TWO_SIDED|95.0|36.5|196.1||Threshold for significance at 0.05 level|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||196.1|36.5|<0.0001
71666134|NCT02585778|142846594|SUPERIORITY||Odds Ratio (OR)|52.9|||<|0.0001|TWO_SIDED|95.0|16.6|168.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||168.3|16.6|<0.0001
71666135|NCT02585778|142846595|SUPERIORITY||Odds Ratio (OR)|33.2|||<|0.0001|TWO_SIDED|95.0|8.0|137.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||137.4|8.0|<0.0001
71666136|NCT02585778|142846595|SUPERIORITY||Odds Ratio (OR)|27.1|||<|0.0001|TWO_SIDED|95.0|14.2|51.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||51.5|14.2|<0.0001
71666137|NCT02585778|142846596|SUPERIORITY||Odds Ratio (OR)|55.5||||0.0002|TWO_SIDED|95.0|6.5|473.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||473.7|6.5|0.0002
71666138|NCT02585778|142846596|SUPERIORITY||Odds Ratio (OR)|103.3|||<|0.0001|TWO_SIDED|95.0|24.6|433.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||433.1|24.6|<0.0001
71666139|NCT02585778|142846597|SUPERIORITY||Adjusted Mean Difference|-18.7||||0.0039|TWO_SIDED|95.0|-31.4|-6.0||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-6.0|-31.4|0.0039
71666140|NCT02585778|142846597|SUPERIORITY||Adjusted Mean Difference|-18.4|||<|0.0001|TWO_SIDED|95.0|-23.7|-13.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||-13.2|-23.7|<0.0001
71666141|NCT02585778|142846598|SUPERIORITY||LS Mean Difference|3.9||||0.3434|TWO_SIDED|95.0|-4.2|12.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||12.0|-4.2|0.3434
71666142|NCT02585778|142846598|SUPERIORITY||LS Mean Difference|4.4||||0.01|TWO_SIDED|95.0|1.1|7.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||7.7|1.1|0.0100
71666143|NCT02585778|142846599|SUPERIORITY||Adjusted Mean Difference|-5.7||||0.0902|TWO_SIDED|95.0|-12.3|0.9||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).||0.9|-12.3|0.0902
71779603|NCT01332500|143059205|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||Opioid tablets|paired t-test 2-sided|||||||0.832
71779604|NCT01332500|143059205|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||Ergot tablets|paired t-test 2-sided|||||||0.392
71779605|NCT01332500|143059205|SUPERIORITY_OR_OTHER|||||||0.752||95.0||||Other tablets|paired t-test 2-sided|||||||0.752
71779606|NCT01332500|143059206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plan costs|paired t-test 2-sided|||||||<0.001
71891166|NCT00190775|143304291|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.547
71891167|NCT00190775|143304291|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.059
71891168|NCT00190775|143304291|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
71891169|NCT00190775|143304292|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.334
71666144|NCT05246670|142846658|SUPERIORITY||Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|-1.33|5.74||||||||5.74|-1.33|
71666145|NCT05246670|142846658|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-5.23|5.41||||||||5.41|-5.23|
71891170|NCT00190775|143304292|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.087
71666146|NCT05246670|142846658|SUPERIORITY||Mean Difference (Final Values)|2.11|||||TWO_SIDED|95.0|-2.87|7.09||||||||7.09|-2.87|
71666147|NCT00911300|142846692|SUPERIORITY_OR_OTHER||Percentage of participants|0.5||||1|TWO_SIDED|95.0|-2.0|3.1|||Fisher Exact||The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.|||3.1|-2.0|1.000
71666148|NCT05879991|142846703|OTHER||Ratio of adjusted geometric means [%]|76.18|||||TWO_SIDED|90.0|70.21|82.65|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|"Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale.~The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale."||82.65|70.21|
71666149|NCT05879991|142846708|OTHER||Ratio of adjusted geometric means [%]|26.1|||||TWO_SIDED|90.0|22.12|30.79|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 16.0|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||30.79|22.12|
71666150|NCT05879991|142846709|OTHER||Ratio of adjusted geometric means [%]|76.99|||||TWO_SIDED|90.0|70.92|83.59|||||Ratio \[%\] = (adjusted geometric mean zongertinib / adjusted geometric mean \[14C\]zongertinib)\*100. Intra-individual geometric coefficient of variation (gCV) \[%\] = 7.9|Ratio of adjusted geometric means was calculated using an ANOVA model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model, which included the effect 'subjects' as a random effect and 'treatment' as a fixed effect. These quantities were then back-transformed to the original scale.||83.59|70.92|
71666151|NCT01685840|142846715|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.88|TWO_SIDED|95.0|0.79|1.22||A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM.|Regression, Cox|||||1.22|0.79|0.88
71666152|NCT01685840|142846716|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.37|TWO_SIDED|95.0|0.62|1.2|||Regression, Cox|||||1.20|0.62|0.37
71666153|NCT01685840|142846717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0||||0.53|TWO_SIDED|95.0|-20.0|39.0|||Bang-Tsiatis Partitioned Estimator|||||39|-20|0.53
71666154|NCT01685840|142846718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.65|1.37|||Regression, Cox|||||1.37|0.65|0.75
71666155|NCT01685840|142846719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.76|TWO_SIDED|95.0|0.82|1.31|||Regression, Cox|||||1.31|0.82|0.76
71779607|NCT01332500|143059206|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided|||||||0.054
71666156|NCT01685840|142846720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.08|TWO_SIDED|95.0|0.97|1.72|||Anderson-Gill Intensity Model|||||1.72|0.97|0.08
71666157|NCT01685840|142846721|SUPERIORITY|||||||0.636|||||||Mixed Models Analysis|||Baseline||||0.636
71666158|NCT01685840|142846721|SUPERIORITY|||||||0.628|||||||Mixed Models Analysis|||3 month||||0.628
71666159|NCT01685840|142846721|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||6 month||||0.586
71666160|NCT01685840|142846721|SUPERIORITY|||||||0.669|||||||Mixed Models Analysis|||12 month||||0.669
71666161|NCT01685840|142846721|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||24 month||||0.949
71666162|NCT01685840|142846722|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.404|TWO_SIDED|95.0|-1.188|2.947||Adjusted P-value|Mixed Models Analysis|||3 month||2.947|-1.188|0.404
71666163|NCT01685840|142846722|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.219|TWO_SIDED|95.0|-0.881|3.836||Adjusted P-value|Mixed Models Analysis|||6 month||3.836|-0.881|0.219
71666164|NCT01685840|142846722|SUPERIORITY||Mean Difference (Final Values)|2.099||||0.104|TWO_SIDED|95.0|-0.433|4.63||Adjusted P-value|Mixed Models Analysis|||12 month||4.630|-0.433|0.104
71666165|NCT01685840|142846722|SUPERIORITY||Mean Difference (Final Values)|1.999||||0.228|TWO_SIDED|95.0|-1.253|5.25|||Mixed Models Analysis|||24 month||5.250|-1.253|0.228
71666166|NCT01685840|142846723|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.421|TWO_SIDED|95.0|-0.025|0.06||Adjusted P-value|Mixed Models Analysis|||3 month||0.060|-0.025|0.421
71779608|NCT01332500|143059206|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Opioid health plan costs|paired t-test 2-sided|||||||0.590
71891171|NCT00190775|143304292|SUPERIORITY_OR_OTHER|||||||0.795||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.795
71891172|NCT00190775|143304292|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.955
71891173|NCT00190775|143304292|SUPERIORITY_OR_OTHER|||||||0.788||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.788
71891174|NCT00190775|143304293|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.248
71891175|NCT00190775|143304293|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.163
71666167|NCT01685840|142846723|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.239|TWO_SIDED|95.0|-0.018|0.074||Adjusted P-value|Mixed Models Analysis|||6 month||0.074|-0.018|0.239
71666168|NCT01685840|142846723|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.402|TWO_SIDED|95.0|-0.028|0.07|||Mixed Models Analysis|||12 month||0.070|-0.028|0.402
71666169|NCT01685840|142846723|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.78|TWO_SIDED|95.0|-0.057|0.076||Adjusted P-value|Mixed Models Analysis|||24 month||0.076|-0.057|0.780
71746436|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-7.9||||0.627|TWO_SIDED|95.0|-28.5|12.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 36||12.8|-28.5|0.627
71746437|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-10.0||||1|TWO_SIDED|95.0|-23.1|3.1||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||3.1|-23.1|1.000
71746438|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|-0.5||||1|TWO_SIDED|95.0|-18.7|17.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||17.7|-18.7|1.000
71746439|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|4.3||||1|TWO_SIDED|95.0|-18.3|26.8||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 44||26.8|-18.3|1.000
71746440|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|14.3||||0.232|TWO_SIDED|95.0|-0.7|29.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||29.3|-0.7|0.232
71746441|NCT02365649|143002039|SUPERIORITY||Risk Difference (RD)|7.1||||0.412|TWO_SIDED|95.0|-6.3|20.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells have expected cell count \< 5).|Chi-squared||Risk difference = upadacitinib higher dose - upadacitinib lower dose. 95% confidence intervals for risk difference were calculated based on normal approximation using proc freq.|Clinical non-responders, Week 52||20.6|-6.3|0.412
71746442|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-745.7||||0.356|TWO_SIDED|95.0|-2369.73|878.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||878.37|-2369.73|0.356
71746443|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-1119.5||||0.158|TWO_SIDED|95.0|-2698.52|459.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||459.50|-2698.52|0.158
71746444|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-1166.0||||0.322|TWO_SIDED|95.0|-3531.3|1199.32||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||1199.32|-3531.30|0.322
71746445|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-828.2||||0.287|TWO_SIDED|95.0|-2387.16|730.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||730.75|-2387.16|0.287
71746446|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-1286.1||||0.088|TWO_SIDED|95.0|-2772.59|200.43||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Responders, Week 52||200.43|-2772.59|0.088
71746447|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-502.2||||0.613|TWO_SIDED|95.0|-2505.74|1501.38||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||1501.38|-2505.74|0.613
71746448|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|283.4||||0.609|TWO_SIDED|95.0|-823.64|1390.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1390.49|-823.64|0.609
71779609|NCT01332500|143059206|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Ergot health plan costs|paired t-test 2-sided|||||||0.382
71779610|NCT01332500|143059206|SUPERIORITY_OR_OTHER|||||||0.343||95.0||||Other health plan costs|paired t-test 2-sided|||||||0.343
71779611|NCT01332500|143059206|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Total health plan costs|paired t-test 2-sided|||||||<0.001
71779612|NCT01332500|143059207|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Triptan health plus copay costs|paired t-test 2-sided|||||||<0.001
71779613|NCT01332500|143059207|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||Non-steroidal anti-inflammatory drug health plus copay costs|paired t-test 2-sided|||||||0.146
71779614|NCT01332500|143059207|SUPERIORITY_OR_OTHER|||||||0.826||95.0||||Opioid health plus copay costs|paired t-test 2-sided|||||||0.826
71891176|NCT00190775|143304293|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.947
71666170|NCT01685840|142846724|SUPERIORITY||Mean Difference (Final Values)|-2.131||||0.268|TWO_SIDED|95.0|-5.902|1.64||Adjusted P-value|Mixed Models Analysis|||3 month||1.640|-5.902|0.268
71666171|NCT01685840|142846724|SUPERIORITY||Mean Difference (Final Values)|1.069||||0.599|TWO_SIDED|95.0|-2.921|5.058|||Mixed Models Analysis|||6 month||5.058|-2.921|0.599
71746449|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-78.2||||0.855|TWO_SIDED|95.0|-930.47|774.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||774.16|-930.47|0.855
71746450|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|283.5||||0.584|TWO_SIDED|95.0|-751.66|1318.57||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||1318.57|-751.66|0.584
71746451|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|356.6||||0.624|TWO_SIDED|95.0|-1095.03|1808.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1808.19|-1095.03|0.624
71746452|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-135.1||||0.806|TWO_SIDED|95.0|-1233.48|963.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||963.25|-1233.48|0.806
71746453|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|186.2||||0.793|TWO_SIDED|95.0|-1229.59|1602.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||1602.06|-1229.59|0.793
71746454|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-304.8||||0.561|TWO_SIDED|95.0|-1350.04|740.44||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||740.44|-1350.04|0.561
71746455|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-1119.0||||0.024|TWO_SIDED|95.0|-2083.81|-154.11||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 28||-154.11|-2083.81|0.024
71746456|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-819.3||||0.156|TWO_SIDED|95.0|-1959.79|321.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||321.21|-1959.79|0.156
71746457|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-346.6||||0.58|TWO_SIDED|95.0|-1592.66|899.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||899.45|-1592.66|0.580
71779615|NCT01332500|143059207|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||Ergot health plus copay costs|paired t-test 2-sided|||||||0.354
71746458|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-1275.9||||0.029|TWO_SIDED|95.0|-2415.88|-135.92||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders, Week 52||-135.92|-2415.88|0.029
71746459|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-534.9||||0.431|TWO_SIDED|95.0|-1883.23|813.5||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||813.50|-1883.23|0.431
71779616|NCT01332500|143059207|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||Other health plus copay costs|paired t-test 2-sided|||||||0.514
71891177|NCT00190775|143304293|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.214
71666172|NCT01685840|142846724|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.852|TWO_SIDED|95.0|-4.486|3.707||Adjusted P-value|Mixed Models Analysis|||12 month||3.707|-4.486|0.852
71746460|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|-25.4||||0.965|TWO_SIDED|95.0|-1200.67|1149.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1149.95|-1200.67|0.965
71746461|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|623.6||||0.123|TWO_SIDED|95.0|-183.52|1430.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1430.64|-183.52|0.123
71746462|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|368.2||||0.591|TWO_SIDED|95.0|-1031.23|1767.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||1767.60|-1031.23|0.591
71746463|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|192.2||||0.642|TWO_SIDED|95.0|-648.22|1032.68||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1032.68|-648.22|0.642
71666173|NCT01685840|142846724|SUPERIORITY||Mean Difference (Final Values)|-3.343||||0.221|TWO_SIDED|95.0|-8.708|2.022||Adjusted P-value|Mixed Models Analysis|||24 month||2.022|-8.708|0.221
71666174|NCT01685840|142846725|SUPERIORITY||Mean Difference (Final Values)|-0.816||||0.615|TWO_SIDED|95.0|-3.999|2.367||Adjusted P-value|Mixed Models Analysis|||3 month||2.367|-3.999|0.615
71666175|NCT01685840|142846725|SUPERIORITY||Mean Difference (Final Values)|0.252||||0.878|TWO_SIDED|95.0|-2.977|3.482||Adjusted P-value|Mixed Models Analysis|||6 month||3.482|-2.977|0.878
71666176|NCT01685840|142846725|SUPERIORITY||Mean Difference (Final Values)|-1.406||||0.441|TWO_SIDED|95.0|-4.989|2.178||Adjusted P-value|Mixed Models Analysis|||12 month||2.178|-4.989|0.441
71666177|NCT01685840|142846725|SUPERIORITY||Mean Difference (Final Values)|1.091||||0.653|TWO_SIDED|95.0|-3.673|5.856||Adjusted P-value|Mixed Models Analysis|||24 month||5.856|-3.673|0.653
71666178|NCT01685840|142846726|SUPERIORITY||Mean Difference (Final Values)|-1.226||||0.199|TWO_SIDED|95.0|-3.097|0.645||Adjusted P-value|Mixed Models Analysis|||3 month||0.645|-3.097|0.199
71666179|NCT01685840|142846726|SUPERIORITY||Mean Difference (Final Values)|-0.742||||0.465|TWO_SIDED|95.0|-2.735|1.25|||Mixed Models Analysis|||6 month||1.250|-2.735|0.465
71666180|NCT01685840|142846726|SUPERIORITY||Mean Difference (Final Values)|-0.074||||0.943|TWO_SIDED|95.0|-2.119|1.97||Adjusted P-value|Mixed Models Analysis|||12 month||1.970|-2.119|0.943
71666181|NCT01685840|142846726|SUPERIORITY||Mean Difference (Final Values)|1.478||||0.294|TWO_SIDED|95.0|-1.286|4.241||Adjusted P-value|Mixed Models Analysis|||24 month||4.241|-1.286|0.294
71666182|NCT01685840|142846727|SUPERIORITY||Mean Difference (Final Values)|-1.579||||0.294|TWO_SIDED|95.0|-4.527|1.369||Adjusted P-value|Mixed Models Analysis|||3 month||1.369|-4.527|0.294
71666183|NCT01685840|142846727|SUPERIORITY||Mean Difference (Final Values)|-0.946||||0.555|TWO_SIDED|95.0|-4.096|2.203||Adjusted P-value|Mixed Models Analysis|||6 month||2.203|-4.096|0.555
71666184|NCT01685840|142846727|SUPERIORITY||Mean Difference (Final Values)|-0.798||||0.643|TWO_SIDED|95.0|-4.178|2.583||Adjusted P-value|Mixed Models Analysis|||12 month||2.583|-4.178|0.643
71779617|NCT01332500|143059207|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Total health plus copay costs|paired t-test 2-sided|||||||0.001
71779618|NCT02280304|143059209|SUPERIORITY||||||>|0.05||||||A priori threshold = voxel p\<.001, cluster p\<.05, FDR whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design. To report NS p-values and associated z-scores, uncorrected cluster ps were queried.|t-test, 1 sided|||Z-scores represent Fisher transformed correlation coefficients representing the correlations between hypothesized regions. Positive values represents positive connectivity between regions. Negative values represent anticorrelations, or negative relations, between hypothesized regions.||||>0.05
71779619|NCT02280304|143059210|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
71779620|NCT02280304|143059210|OTHER||Cohen's d|0.35|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation subscale of the CRIS, Post - Pre|||||
71779621|NCT02280304|143059210|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
71779622|NCT02280304|143059210|OTHER||Cohen's d|0.14|||||TWO_SIDED||||||||Cohen's d reflects Extent of Participation Scale of the Cris pre- post|||||
71779623|NCT02280304|143059210|OTHER||Median Difference (Net)|0.8|||||TWO_SIDED|||||||||||||
71779624|NCT02280304|143059210|OTHER||Cohen's d|0.2|||||TWO_SIDED||||||||Cohens d reflects the Cris pre post Perceived Limitations scale|||||
71779625|NCT02280304|143059210|OTHER||Mean Difference (Net)|1.8|||||TWO_SIDED|||||||||||||
71779626|NCT02280304|143059210|OTHER||Cohens d|0.53|||||TWO_SIDED|||||||||||||
71779627|NCT02280304|143059210|OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|||||||||||||
71779628|NCT02280304|143059210|OTHER||Cohens d|0.29|||||TWO_SIDED|||||||||||||
71779629|NCT02280304|143059210|OTHER||Mean Difference (Net)|0.6|||||TWO_SIDED|||||||||||||
71779630|NCT02280304|143059210|OTHER||Cohens d|0.13|||||TWO_SIDED|||||||||||||
71779631|NCT02280304|143059211|OTHER||Cohens d|0.86|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
71779632|NCT02280304|143059211|OTHER||Cohens d|0.3|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
71779633|NCT02280304|143059212|OTHER||Cohens d|1.32|||||TWO_SIDED||||||||Cohen's d effect size change (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
71779634|NCT02280304|143059212|OTHER||Cohens d|0.27|||||TWO_SIDED||||||||Cohen's d effect size (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.||||
71779635|NCT02280304|143059213|SUPERIORITY||||||<|0.0099||||||The p-value obtained for the L PHG seed/L IPL cluster is 0.0099. The critical p-value after Bonferroni correction for multiple seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<.0099
71779636|NCT02280304|143059213|SUPERIORITY||||||<|0.02||||||The p-value obtained for the L anterior PGH seed/left VMPC cluster is 0.02. The critical p-value after Bonferroni correction for six seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p\<.001, cluster p\<.05 FDR corrected for multiple comparisons across the whole brain.||||||<0.02
71779637|NCT02280304|143059214|OTHER||Slope|0.02|||<|3.8e-05|TWO_SIDED|||||Cluster in MPFC p\<0.000038 FDR corrected for multiple comparisons across whole brain. Bonferroni correction for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<.000038
71779638|NCT02280304|143059214|OTHER||Slope|0.02|||<|0.000149|TWO_SIDED|||||Cluster in the right cerebellum (crus 2) p\<0.000149 FDR corrected for multiple comparisons across the whole brain. Bonferroni for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).||||<0.000149
71746464|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|455.8||||0.093|TWO_SIDED|95.0|-81.37|992.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical non-responders, Week 52||992.95|-81.37|0.093
71834899|NCT04238247|143174407|SUPERIORITY||Odds Ratio (OR)|0.8686678||||0.671|TWO_SIDED|95.0|0.4535589|1.663695||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||This analysis is limited to the Phase 2 participants who were re-randomized at 6 months to test the hypothesis that the enhanced intervention (with booster MI session) would have greater guideline adherent child passenger safety behaviors at 12 month follow-up than the group that continued in the basic intervention (mHealth components).||1.663695|0.4535589|0.671
71746465|NCT02365649|143002040|SUPERIORITY||LS Mean of Difference|463.6||||0.296|TWO_SIDED|95.0|-428.99|1356.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||1356.20|-428.99|0.296
71746466|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-2.0||||0.822|TWO_SIDED|95.0|-19.83|15.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||15.83|-19.83|0.822
71746467|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-6.4||||0.386|TWO_SIDED|95.0|-20.97|8.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||8.25|-20.97|0.386
71746468|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|12.9||||0.136|TWO_SIDED|95.0|-4.22|29.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 20||29.95|-4.22|0.136
71746469|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|1.0||||0.912|TWO_SIDED|95.0|-17.87|19.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||19.97|-17.87|0.912
71746470|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-12.3||||0.118|TWO_SIDED|95.0|-27.77|3.25||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||3.25|-27.77|0.118
71746471|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|12.5||||0.171|TWO_SIDED|95.0|-5.61|30.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 28||30.65|-5.61|0.171
71746472|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-6.9||||0.479|TWO_SIDED|95.0|-26.5|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||12.63|-26.50|0.479
71746473|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-17.1||||0.037|TWO_SIDED|95.0|-33.12|-1.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders, Week 36||-1.04|-33.12|0.037
71746474|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|6.9||||0.463|TWO_SIDED|95.0|-11.86|25.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 36||25.65|-11.86|0.463
71746475|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-4.6||||0.627|TWO_SIDED|95.0|-23.59|14.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||14.37|-23.59|0.627
71746476|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-12.2||||0.122|TWO_SIDED|95.0|-27.75|3.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||3.37|-27.75|0.122
71746477|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|10.7||||0.243|TWO_SIDED|95.0|-7.49|28.89||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 44||28.89|-7.49|0.243
71746478|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-4.2||||0.658|TWO_SIDED|95.0|-22.95|14.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||14.63|-22.95|0.658
71746479|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-12.3||||0.115|TWO_SIDED|95.0|-27.69|3.12||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||3.12|-27.69|0.115
71834900|NCT04238247|143174407|SUPERIORITY||Odds Ratio (OR)|6.859599|||<|0.001|TWO_SIDED|95.0|3.173121|14.82896|||Regression, Logistic|||||14.82896|3.173121|<0.001
71834901|NCT04238247|143174410|SUPERIORITY||Odds Ratio (OR)|1.74029||||0.032|TWO_SIDED|95.0|1.049169|2.886676||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.886676|1.049169|0.032
71891178|NCT00190775|143304293|SUPERIORITY_OR_OTHER|||||||0.543||95.0||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.543
71746480|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|10.0||||0.267|TWO_SIDED|95.0|-7.96|28.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders, Week 52||28.06|-7.96|0.267
71746481|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.2||||0.974|TWO_SIDED|95.0|-9.74|10.06||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||10.06|-9.74|0.974
71746482|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.5||||0.882|TWO_SIDED|95.0|-7.61|6.55||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||6.55|-7.61|0.882
71779639|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07||||0.533|TWO_SIDED|90.0|-1.82|3.95|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on analysis of covariance (ANCOVA) using statistical analysis system (SAS) mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.95|-1.82|0.5330
71779640|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14||||0.9532|TWO_SIDED|90.0|-4.13|3.85|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.85|-4.13|0.9532
71779641|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.53||||0.2493|TWO_SIDED|90.0|-1.11|6.18|||ANCOVA|||Change at Day 14 12 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||6.18|-1.11|0.2493
71779642|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99||||0.2801|TWO_SIDED|90.0|-7.59|1.6|||ANCOVA|||Change at Day 14 2 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||1.60|-7.59|0.2801
71779643|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19||||0.9288|TWO_SIDED|90.0|-3.77|3.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.39|-3.77|0.9288
71779644|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.6459|TWO_SIDED|90.0|-2.62|4.58|||ANCOVA|||Change at Day 14 6 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.58|-2.62|0.6459
71779645|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.06||||0.0527|TWO_SIDED|90.0|0.63|7.48|||ANCOVA|||Change at Day 14 8 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.48|0.63|0.0527
71779646|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29||||0.1998|TWO_SIDED|90.0|-0.95|7.52|||ANCOVA|||Change at Day 14 10 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||7.52|-0.95|0.1998
71779647|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.6765|TWO_SIDED|90.0|-4.22|2.53|||ANCOVA|||Change at Day 15 12 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||2.53|-4.22|0.6765
71779648|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.6221|TWO_SIDED|90.0|-2.35|4.33|||ANCOVA|||Change at Day 15 4 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.33|-2.35|0.6221
71779649|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.3|TWO_SIDED|90.0|-1.11|4.74|||ANCOVA|||Change at Day 15 6 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||4.74|-1.11|0.3000
71779650|NCT00934089|143059245|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24||||0.9103|TWO_SIDED|90.0|-3.85|3.37|||ANCOVA|||Change at Day 15 8 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||3.37|-3.85|0.9103
71779651|NCT00934089|143059247|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|59.2|||<|0.001|TWO_SIDED|95.0|38.69|79.7|||Fisher Exact|||Photophobia: p-value was calculated using fisher exact test.||79.70|38.69|<0.001
71779652|NCT00934089|143059247|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.56||||0.612|TWO_SIDED|95.0|-14.8|7.68|||Fisher Exact|||Iritis: p-value was calculated using fisher exact test.||7.68|-14.80|0.612
71834902|NCT04238247|143174411|SUPERIORITY||Odds Ratio (OR)|1.112874||||0.752|TWO_SIDED|95.0|0.5735782|2.159233||The threshold for statistical significance was p = 0.05.|Regression, Logistic|||||2.159233|0.5735782|0.752
71834903|NCT04238247|143174411|SUPERIORITY||Odds Ratio (OR)|7.959981|||<|0.001|TWO_SIDED|95.0|3.321933|19.07362|||Regression, Logistic|||||19.07362|3.321933|<0.001
71666185|NCT01685840|142846727|SUPERIORITY||Mean Difference (Final Values)|-0.647||||0.757|TWO_SIDED|95.0|-4.767|3.472||Adjusted P-value|Mixed Models Analysis|||24 month||3.472|-4.767|0.757
71746483|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.1||||0.982|TWO_SIDED|95.0|-7.92|7.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 20||7.75|-7.92|0.982
71746484|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|2.2||||0.673|TWO_SIDED|95.0|-8.11|12.51||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||12.51|-8.11|0.673
71746485|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|2.7||||0.467|TWO_SIDED|95.0|-4.64|10.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.04|-4.64|0.467
71746486|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|2.2||||0.583|TWO_SIDED|95.0|-5.79|10.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 28||10.23|-5.79|0.583
71746487|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|5.5||||0.564|TWO_SIDED|95.0|-13.33|24.31||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||24.31|-13.33|0.564
71746488|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-2.4||||0.728|TWO_SIDED|95.0|-15.74|11.04||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||11.04|-15.74|0.728
71746489|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|5.5||||0.46|TWO_SIDED|95.0|-9.16|20.08||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 36||20.08|-9.16|0.460
71746490|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|12.0||||0.253|TWO_SIDED|95.0|-8.72|32.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||32.75|-8.72|0.253
71746491|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|1.1||||0.884|TWO_SIDED|95.0|-13.67|15.84||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||15.84|-13.67|0.884
71746492|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|5.8||||0.474|TWO_SIDED|95.0|-10.28|21.95||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 44||21.95|-10.28|0.474
71746493|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|3.6||||0.727|TWO_SIDED|95.0|-17.03|24.3||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||24.30|-17.03|0.727
71746494|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|2.1||||0.78|TWO_SIDED|95.0|-12.63|16.78||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||16.78|-12.63|0.780
71779653|NCT00934089|143059249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.42||||0.245|TWO_SIDED|90.0|-127.05|22.22|||ANCOVA|||Change at Day 13 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||22.22|-127.05|0.2450
71666186|NCT01685840|142846728|SUPERIORITY||Mean Difference (Final Values)|-0.484||||0.837|TWO_SIDED|95.0|-5.102|4.133||Adjusted P-value|Mixed Models Analysis|||3 month||4.133|-5.102|0.837
71779654|NCT00934089|143059249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.51||||0.3068|TWO_SIDED|90.0|-21.89|90.91|||ANCOVA|||Change at Day 13 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||90.91|-21.89|0.3068
71746495|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|6.5||||0.424|TWO_SIDED|95.0|-9.57|22.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders, Week 52||22.54|-9.57|0.424
71746496|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-1.3||||0.841|TWO_SIDED|95.0|-14.23|11.62||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||11.62|-14.23|0.841
71746497|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-2.1||||0.702|TWO_SIDED|95.0|-12.94|8.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||8.75|-12.94|0.702
71746498|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|5.7||||0.353|TWO_SIDED|95.0|-6.43|17.83||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 20||17.83|-6.43|0.353
71834904|NCT03092726|143174412|SUPERIORITY||LS Mean (LSM) Difference|0.06|STANDARD_ERROR_OF_MEAN|0.26||0.59|TWO_SIDED|90.0|-0.38|0.5||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Differences of least squares (LS) means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a mixed-effect, repeated measures (MMRM) model with change from baseline to each week from weeks 1 to 8 as response, treatment, center (pooled where necessary), time (study weeks 1 to 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||0.50|-0.38|0.590
71666187|NCT01685840|142846728|SUPERIORITY||Mean Difference (Final Values)|-2.693||||0.288|TWO_SIDED|95.0|-7.662|2.276||Adjusted P-value|Mixed Models Analysis|||6 month||2.276|-7.662|0.288
71746499|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|2.1||||0.77|TWO_SIDED|95.0|-11.89|16.0||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||16.00|-11.89|0.770
71834905|NCT03092726|143174416|SUPERIORITY||Difference of percentages|-6.6||||0.874|TWO_SIDED|90.0|-18.7|5.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||5.7|-18.7|0.874
71746500|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-5.3||||0.367|TWO_SIDED|95.0|-17.04|6.37||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||6.37|-17.04|0.367
71746501|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|7.0||||0.291|TWO_SIDED|95.0|-6.09|20.07||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 28||20.07|-6.09|0.291
71746502|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.7||||0.942|TWO_SIDED|95.0|-20.87|19.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||19.40|-20.87|0.942
71746503|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-12.0||||0.162|TWO_SIDED|95.0|-28.89|4.91||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||4.91|-28.89|0.162
71746504|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|10.9||||0.253|TWO_SIDED|95.0|-7.96|29.82||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 36||29.82|-7.96|0.253
71746505|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|5.5||||0.617|TWO_SIDED|95.0|-16.25|27.21||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||27.21|-16.25|0.617
71746506|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-6.0||||0.515|TWO_SIDED|95.0|-24.22|12.24||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||12.24|-24.22|0.515
71746507|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|13.8||||0.18|TWO_SIDED|95.0|-6.53|34.23||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 44||34.23|-6.53|0.180
71666188|NCT01685840|142846728|SUPERIORITY||Mean Difference (Final Values)|-1.539||||0.567|TWO_SIDED|95.0|-6.81|3.732||Adjusted P-value|Mixed Models Analysis|||12 month||3.732|-6.810|0.567
71666189|NCT01685840|142846728|SUPERIORITY||Mean Difference (Final Values)|2.512||||0.475|TWO_SIDED|95.0|-4.394|9.419||Adjusted P-value|Mixed Models Analysis|||24 month||9.419|-4.394|0.475
71666190|NCT01685840|142846729|SUPERIORITY||Mean Difference (Final Values)|1.057||||0.696|TWO_SIDED|95.0|-4.25|6.364||Adjusted P-value|Mixed Models Analysis|||3 month||6.364|-4.250|0.696
71746508|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.4||||0.972|TWO_SIDED|95.0|-21.86|21.09||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||21.09|-21.86|0.972
71746509|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-4.9||||0.589|TWO_SIDED|95.0|-22.94|13.1||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||13.10|-22.94|0.589
71746510|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|14.1||||0.168|TWO_SIDED|95.0|-6.07|34.22||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders, Week 52||34.22|-6.07|0.168
71746511|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|1.9||||0.712|TWO_SIDED|95.0|-8.5|12.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||12.36|-8.50|0.712
71834906|NCT03092726|143174416|SUPERIORITY||Differences of percentages|-5.6||||0.838|TWO_SIDED|90.0|-17.7|6.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||6.7|-17.7|0.838
71834907|NCT03092726|143174417|SUPERIORITY||Differences of percentages|2.2||||0.412|TWO_SIDED|90.0|-10.0|14.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||14.4|-10.0|0.412
71834908|NCT03092726|143174417|SUPERIORITY||Differences of percentages|4.3||||0.269|TWO_SIDED|90.0|-7.9|16.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.||16.4|-7.9|0.269
71834909|NCT03092726|143174418|SUPERIORITY||LSM Difference|-0.68|STANDARD_ERROR_OF_MEAN|2.03||0.369|TWO_SIDED|90.0|-4.05|2.68||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||2.68|-4.05|0.369
71834910|NCT03092726|143174418|SUPERIORITY||LSM Difference|-0.64|STANDARD_ERROR_OF_MEAN|2.34||0.393|TWO_SIDED|90.0|-4.51|3.24||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.24|-4.51|0.393
71834911|NCT03092726|143174418|SUPERIORITY||LSM Difference|0.86|STANDARD_ERROR_OF_MEAN|2.68||0.626|TWO_SIDED|90.0|-3.57|5.3|||MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.30|-3.57|0.626
71834912|NCT03092726|143174418|SUPERIORITY||LSM Difference|1.09|STANDARD_ERROR_OF_MEAN|2.57||0.664|TWO_SIDED|90.0|-3.16|5.34||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.34|-3.16|0.664
71666191|NCT01685840|142846729|SUPERIORITY||Mean Difference (Final Values)|1.966||||0.497|TWO_SIDED|95.0|-3.715|7.647||Adjusted P-value|Mixed Models Analysis|||6 months||7.647|-3.715|0.497
71666192|NCT01685840|142846729|SUPERIORITY||Mean Difference (Final Values)|6.564||||0.035|TWO_SIDED|95.0|0.456|12.673||Adjusted P-value|Mixed Models Analysis|||12 month||12.673|0.456|0.035
71666193|NCT01685840|142846729|SUPERIORITY||Mean Difference (Final Values)|2.857||||0.488|TWO_SIDED|95.0|-5.247|10.961||Adjusted P-value|Mixed Models Analysis|||24 month||10.961|-5.247|0.488
71834913|NCT03092726|143174419|SUPERIORITY||LSM Difference|0.16|STANDARD_ERROR_OF_MEAN|1.85||0.534|TWO_SIDED|90.0|-2.9|3.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||3.22|-2.90|0.534
71834914|NCT03092726|143174419|SUPERIORITY||LSM Difference|1.46|STANDARD_ERROR_OF_MEAN|2.08||0.758|TWO_SIDED|90.0|-1.98|4.91||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||4.91|-1.98|0.758
71891179|NCT00190775|143304294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.05||0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.||||0.001
71666194|NCT01685840|142846730|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.992|TWO_SIDED|95.0|-3.383|3.417||Adjusted P-value|Mixed Models Analysis|||3 month||3.417|-3.383|0.992
71666195|NCT01685840|142846730|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.882|TWO_SIDED|95.0|-3.409|3.969||Adjusted P-value|Mixed Models Analysis|||6 month||3.969|-3.409|0.882
71666196|NCT01685840|142846730|SUPERIORITY||Mean Difference (Final Values)|0.904||||0.647|TWO_SIDED|95.0|-2.973|4.782||Adjusted P-value|Mixed Models Analysis|||12 month||4.782|-2.973|0.647
71666197|NCT01685840|142846730|SUPERIORITY||Mean Difference (Final Values)|0.322||||0.903|TWO_SIDED|95.0|-4.894|5.538||Adjusted P-value|Mixed Models Analysis|||24 month||5.538|-4.894|0.903
71666198|NCT01685840|142846731|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Hospitalizations||||0.74
71891180|NCT00190775|143304295|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.446
71666199|NCT01685840|142846731|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||ER only events||||0.45
71666200|NCT01685840|142846731|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Rehab facilities||||0.67
71779655|NCT00934089|143059249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99||||0.2632|TWO_SIDED|90.0|-19.69|101.67|||ANCOVA|||Change at Day 35 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||101.67|-19.69|0.2632
71779656|NCT00934089|143059249|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6||||0.8373|TWO_SIDED|90.0|-60.84|47.64|||ANCOVA|||Change at Day 35 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.||47.64|-60.84|0.8373
71779657|NCT00680017|143059277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison."|Wilcoxon rank-sum test|||The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.||||<0.001
71779658|NCT00680017|143059278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 secondary endpoint comparison."|ANCOVA|P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.||The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.||||<0.001
71779659|NCT00434954|143059281|NON_INFERIORITY_OR_EQUIVALENCE|The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).|Mean Difference (Net)|0.14||||0.055|TWO_SIDED|95.0|-0.003|0.291||Non-inferiority: upper limit of 95% Confidence Interval (CI) to be \< 0.4%.|Mixed effect model repeat measures(MMRM)|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.||0.291|-0.003|0.055
71779660|NCT00434954|143059282|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||Chi square test (Pearson)|||||||0.554
71779661|NCT00434954|143059283|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi square test (Pearson)|||||||0.159
71666201|NCT01685840|142846731|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Total admissions||||0.47
71779662|NCT00434954|143059288|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Non overlapping 95% CI's: statistically significant difference p\<0.05.|Kaplan-Meier analysis|For each treatment group, the incidence of hypoglycemia at Week 26 and 95% CIs were derived from Kaplan-Meier analysis.||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).||||<0.05
71779663|NCT00434954|143059289|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at baseline \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
71779664|NCT00434954|143059290|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at Visit 1 \>= 6.5% and \<= 8.0% vs. \> 8.0% and \<=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)||||||<0.0001
71779665|NCT00944671|143059297|NON_INFERIORITY_OR_EQUIVALENCE|Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
71891181|NCT00190775|143304295|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.134
71666202|NCT01685840|142846732|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Hospital Costs||||0.88
71666203|NCT01685840|142846732|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Physician Fees||||0.69
71666204|NCT01685840|142846732|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Total Cost||||0.88
71666205|NCT01406444|142846733|SUPERIORITY|||||||0.03|||||||Linear random effects model|||||||0.03
71666206|NCT01406444|142846734|SUPERIORITY|||||||0.002|||||||Linear random effects model|||||||0.002
71666207|NCT01406444|142846734|SUPERIORITY|||||||0.04|||||||Linear random effects model|||||||0.04
71666208|NCT02211417|142846739|SUPERIORITY|||||||0.057|||||||Cochran-Mantel-Haenszel|||||||0.057
71666209|NCT04700137|142846760|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.31|TWO_SIDED|95.0|-3.0|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among patients by intervention arm at follow-up (6 months).||1.0|-3.0|0.31
71666210|NCT04700137|142846760|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.83|TWO_SIDED|95.0|-1.8|2.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.|A T-score of 50 represents the mean of the US general population (based on the 2010 Census) and 10 T-score units represents one standard deviation. Higher T-score indicates higher loneliness.|Difference in loneliness among healthcare providers/staff by intervention arm at follow-up (6 months).||2.2|-1.8|0.83
71666211|NCT04700137|142846761|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.5||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among patients by intervention arm at follow-up (6 months).||0.5|0.0|0.05
71666212|NCT04700137|142846761|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.2|TWO_SIDED|95.0|-0.4|0.1||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in suicidal ideation and behavior (C-SSRS) among healthcare providers/staff by intervention arm at follow-up (6 months).||0.1|-0.4|0.2
71666213|NCT04700137|142846762|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.45|TWO_SIDED|95.0|-1.5|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among patients by intervention arm at follow-up (6 months).||0.7|-1.5|0.45
71666214|NCT04700137|142846762|SUPERIORITY||Median Difference (Final Values)|0.3||||0.51|TWO_SIDED|95.0|-0.7|1.3||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in depression (PHQ-9) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.3|-0.7|0.51
71666215|NCT04700137|142846763|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.54|TWO_SIDED|95.0|-1.3|0.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among patients by intervention arm at follow-up (6 months).||0.7|-1.3|0.54
71666216|NCT04700137|142846763|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED|95.0|0.1|2.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in anxiety (GAD-7) among healthcare providers/staff by intervention arm at follow-up (6 months).||2.0|0.1|0.04
71666217|NCT04700137|142846764|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among patients.||1.7|-2.1|0.84
71666218|NCT04700137|142846764|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.18|TWO_SIDED|95.0|-0.7|3.7||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors.|T-score of 50 = mean of the US general population (2010 Census); 10 T-score units = one standard deviation. Higher T-scores = higher stress. T-scores equal to or greater than 60.5 (adults) or 60.8 (adolescents) are moderate or high risk.|Change in stress from baseline to 6 months among healthcare providers/staff.||3.7|-0.7|0.18
71666219|NCT04700137|142846765|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.38|TWO_SIDED|95.0|-0.6|1.6||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among patients by intervention arm at follow-up (6 months).||1.6|-0.6|0.38
71666220|NCT04700137|142846765|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.81|TWO_SIDED|95.0|-0.8|1.0||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in perceived burdensomeness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||1.0|-0.8|0.81
71666221|NCT04700137|142846765|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.73|TWO_SIDED|95.0|-2.6|1.8||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among patients by intervention arm at follow-up (6 months).||1.8|-2.6|0.73
71666222|NCT04700137|142846765|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.24|TWO_SIDED|95.0|-0.8|3.2||p\<0.05 = a priori threshold for statistical significance|Regression, Linear|Linear regression with robust standard errors, adjusting for the baseline score as a precision variable.||Difference in thwarted belongingness (INQ15) among healthcare providers/staff by intervention arm at follow-up (6 months).||3.2|-0.8|0.24
71666223|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|-5.6||||0.12|TWO_SIDED|95.0|-12.5|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among patients randomized to CC+ vs CC||1.4|-12.5|0.12
71666224|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|-6.1||||0.03|TWO_SIDED|95.0|-11.5|-0.7||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased tobacco use among healthcare providers/staff randomized to CC+ vs CC||-0.7|-11.5|0.03
71666225|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|-1.1||||0.83|TWO_SIDED|95.0|-10.7|8.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among patients randomized to CC+ vs CC||8.5|-10.7|0.83
71746512|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-2.3||||0.465|TWO_SIDED|95.0|-8.41|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||3.90|-8.41|0.465
71746513|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.3||||0.924|TWO_SIDED|95.0|-6.83|7.52||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 20||7.52|-6.83|0.924
71746514|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.4||||0.938|TWO_SIDED|95.0|-8.88|9.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||9.60|-8.88|0.938
71746515|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|2.2||||0.41|TWO_SIDED|95.0|-3.17|7.64||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||7.64|-3.17|0.410
71746516|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.2||||0.941|TWO_SIDED|95.0|-5.89|6.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 28||6.35|-5.89|0.941
71746517|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.7||||0.872|TWO_SIDED|95.0|-8.23|9.67||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||9.67|-8.23|0.872
71746518|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-1.0||||0.692|TWO_SIDED|95.0|-6.27|4.2||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||4.20|-6.27|0.692
71746519|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.4||||0.896|TWO_SIDED|95.0|-6.32|5.54||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 36||5.54|-6.32|0.896
71746520|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|1.0||||0.826|TWO_SIDED|95.0|-7.92|9.87||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||9.87|-7.92|0.826
71746521|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.4||||0.885|TWO_SIDED|95.0|-4.82|5.58||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.58|-4.82|0.885
71834915|NCT03092726|143174419|SUPERIORITY||LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|2.57||0.745|TWO_SIDED|90.0|-2.56|5.96||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||5.96|-2.56|0.745
71666226|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|2.2||||0.67|TWO_SIDED|95.0|-8.0|12.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased alcohol use among healthcare providers/staff randomized to CC+ vs CC||12.5|-8.0|0.67
71746522|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.1||||0.964|TWO_SIDED|95.0|-6.03|5.76||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 44||5.76|-6.03|0.964
71746523|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|1.1||||0.806|TWO_SIDED|95.0|-7.59|9.72||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||9.72|-7.59|0.806
71746524|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|0.4||||0.871|TWO_SIDED|95.0|-4.65|5.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.47|-4.65|0.871
71746525|NCT02365649|143002041|SUPERIORITY||LS Mean of Difference|-0.5||||0.85|TWO_SIDED|95.0|-6.28|5.19||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders, Week 52||5.19|-6.28|0.850
71746526|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|-3.9||||0.792|TWO_SIDED|95.0|-33.73|25.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||25.90|-33.73|0.792
71746527|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|18.1||||0.179|TWO_SIDED|95.0|-8.62|44.75||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||44.75|-8.62|0.179
71891182|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.056
71666227|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|2.9||||0.42|TWO_SIDED|95.0|-4.1|9.9||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among patients randomized to CC+ vs CC||9.9|-4.1|0.42
71666228|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|-2.1||||0.53|TWO_SIDED|95.0|-8.7|4.5||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased marijuana/cannabis use among healthcare providers/staff randomized to CC+ vs CC||4.5|-8.7|0.53
71666229|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|-2.5||||0.2|TWO_SIDED|95.0|-6.3|1.4||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among patients randomized to CC+ vs CC||1.4|-6.3|0.20
71666230|NCT04700137|142846767|SUPERIORITY||Risk Difference (RD)|-0.7||||0.62|TWO_SIDED|95.0|-3.4|2.0||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Number of participants with increased illicit drug use among healthcare providers/staff randomized to CC+ vs CC||2.0|-3.4|0.62
71666231|NCT04700137|142846768|SUPERIORITY||Risk Difference (RD)|-4.5||||0.41|TWO_SIDED|95.0|-15.4|6.3||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of patients attending mental healthcare appointments by intervention arm at follow-up (6 months).||6.3|-15.4|0.41
71666232|NCT04700137|142846768|SUPERIORITY||Risk Difference (RD)|5.5||||0.31|TWO_SIDED|95.0|-5.2|16.2||p\<0.05 = a priori threshold for statistical significance|GLM|Generalized linear model (GLM) with an identity link and binomial variance||Difference in proportion of healthcare providers/staff attending mental healthcare appointments by intervention arm at follow-up (6 months).||16.2|-5.2|0.31
71666233|NCT02687529|142846797|EQUIVALENCE|The number of positive and negative CST001 assay results for each subject, across all sites and operators were compared. In order for a subject to have a concordant result, the same assay call must be observed for all replicates across all sites (6/6).|proportion of concordant calls|83.33|||||TWO_SIDED|95.0|72.13|91.38||||||||91.38|72.13|
71666234|NCT04386616|142846800|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9266|TWO_SIDED|95.0|0.75|1.36||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.75|0.9266
71779666|NCT00944671|143059298|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.13||||||||1.13|0.93|
71779667|NCT00944671|143059299|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05||||||90.0|0.98|1.13||||||||1.13|0.98|
71779668|NCT00944671|143059300|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
71779669|NCT01431989|143059315|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|90.03|STANDARD_DEVIATION|7.53||0|TWO_SIDED|90.0|86.99|93.17|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.17|86.99|0.0000
71779670|NCT01431989|143059316|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|87.93|STANDARD_DEVIATION|13.83||0.0018|TWO_SIDED|90.0|82.55|93.65|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.65|82.55|0.0018
71779671|NCT01431989|143059317|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric means T/R formulation|90.03|STANDARD_DEVIATION|7.51||0|TWO_SIDED|90.0|86.96|93.12|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.|||93.12|86.96|0.0000
71779672|NCT01431989|143059318|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Median Difference (Final Values)|0.125||||0.339|TWO_SIDED|90.0|-0.125|0.375|||Wilcoxon (Mann-Whitney)|The non-parametric method included the following factors: Sequence, Formulation, Period, Formulation and Residual||||0.375|-0.125|0.3390
71779673|NCT03345914|143059322|SUPERIORITY||Percentage difference|18.1|||=|0.0004|TWO_SIDED|95.0|8.28|27.97||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kilograms (kg) or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||27.97|8.28|= 0.0004
71891183|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.459||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.459
71891184|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.435
71746528|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|-19.1||||0.23|TWO_SIDED|95.0|-50.87|12.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||12.63|-50.87|0.230
71746529|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|16.4||||0.337|TWO_SIDED|95.0|-17.54|50.4||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||50.40|-17.54|0.337
71746530|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|1.1||||0.924|TWO_SIDED|95.0|-21.75|23.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.93|-21.75|0.924
71746531|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|-11.7||||0.373|TWO_SIDED|95.0|-37.69|14.35||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||14.35|-37.69|0.373
71746532|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|-3.1||||0.813|TWO_SIDED|95.0|-28.94|22.79||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||22.79|-28.94|0.813
71746533|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|5.3||||0.651|TWO_SIDED|95.0|-18.02|28.65||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||28.65|-18.02|0.651
71746534|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|-23.8||||0.065|TWO_SIDED|95.0|-49.12|1.49||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||1.49|-49.12|0.065
71746535|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|5.3||||0.802|TWO_SIDED|95.0|-37.61|48.28||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||48.28|-37.61|0.802
71746536|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|0.6||||0.955|TWO_SIDED|95.0|-20.46|21.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.63|-20.46|0.955
71746537|NCT02365649|143002042|SUPERIORITY||LS Mean of Difference|-10.6||||0.395|TWO_SIDED|95.0|-35.73|14.47||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||14.47|-35.73|0.395
71891185|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.677
71746538|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|-0.0082||||0.893|TWO_SIDED|95.0|-0.1299|0.1136||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1136|-0.1299|0.893
71746539|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0685||||0.182|TWO_SIDED|95.0|-0.0334|0.1705||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||0.1705|-0.0334|0.182
71746540|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|-0.1323||||0.036|TWO_SIDED|95.0|-0.2552|-0.0093||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||-0.0093|-0.2552|0.036
71746541|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0768||||0.316|TWO_SIDED|95.0|-0.0749|0.2286||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.2286|-0.0749|0.316
71746542|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0573||||0.277|TWO_SIDED|95.0|-0.0471|0.1617||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1617|-0.0471|0.277
71746543|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0428||||0.467|TWO_SIDED|95.0|-0.0741|0.1597||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||0.1597|-0.0741|0.467
71891186|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.376
71891187|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.176
71891188|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.030
71891189|NCT00190775|143304296|SUPERIORITY_OR_OTHER|||||||0.434||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.434
71666235|NCT04386616|142846800|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.357|TWO_SIDED|95.0|0.86|1.54||p\<0.05 threshold for statistical significance|Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.54|0.86|0.3570
71666236|NCT04386616|142846800|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9812|TWO_SIDED|95.0|0.74|1.36||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.36|0.74|0.9812
71666237|NCT04386616|142846800|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5151|TWO_SIDED|95.0|0.82|1.49||p\<0.05 threshold for statistical significance|Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.49|0.82|0.5151
71666238|NCT04386616|142846801|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8373|TWO_SIDED|95.0|0.77|1.39|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.77|0.8373
71746544|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|-0.036||||0.464|TWO_SIDED|95.0|-0.1336|0.0616||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.0616|-0.1336|0.464
71746545|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0404||||0.345|TWO_SIDED|95.0|-0.0444|0.1252||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||0.1252|-0.0444|0.345
71746546|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|-0.0873||||0.071|TWO_SIDED|95.0|-0.1822|0.0076||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||0.0076|-0.1822|0.071
71746547|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.1109||||0.317|TWO_SIDED|95.0|-0.1109|0.3326||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.3326|-0.1109|0.317
71746548|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0848||||0.125|TWO_SIDED|95.0|-0.0248|0.1945||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1945|-0.0248|0.125
71666239|NCT04386616|142846801|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3396|TWO_SIDED|95.0|0.86|1.55|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.55|0.86|0.3396
71666240|NCT04386616|142846801|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8619|TWO_SIDED|95.0|0.76|1.39|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.39|0.76|0.8619
71746549|NCT02365649|143002043|SUPERIORITY||LS Mean of Difference|0.0559||||0.39|TWO_SIDED|95.0|-0.0745|0.1864||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||0.1864|-0.0745|0.390
71746550|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|8.7||||0.263|TWO_SIDED|95.0|-6.79|24.16||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||24.16|-6.79|0.263
71746551|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|15.2||||0.031|TWO_SIDED|95.0|1.47|28.93||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Responders||28.93|1.47|0.031
71779674|NCT03345914|143059322|SUPERIORITY||Percentage difference|21.4|||<|0.0001|TWO_SIDED|95.0|11.36|31.45||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with IGA 0 or 1 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||31.45|11.36|< 0.0001
71891190|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.578
71746552|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|-12.0||||0.135|TWO_SIDED|95.0|-27.93|3.9||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Responders||3.90|-27.93|0.135
71746553|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|6.3||||0.458|TWO_SIDED|95.0|-10.61|23.27||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||23.27|-10.61|0.458
71746554|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|1.9||||0.738|TWO_SIDED|95.0|-9.59|13.45||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||13.45|-9.59|0.738
71891191|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.062
71746555|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|-5.4||||0.412|TWO_SIDED|95.0|-18.32|7.6||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Non-responders||7.60|-18.32|0.412
71746556|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|3.9||||0.534|TWO_SIDED|95.0|-8.56|16.36||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical responders||16.36|-8.56|0.534
71746557|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|11.0||||0.052|TWO_SIDED|95.0|-0.1|22.01||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.1 level.||Clinical responders||22.01|-0.10|0.052
71746558|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|-13.9||||0.027|TWO_SIDED|95.0|-26.15|-1.63||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|Prespecified statistically significant at 0.05 level.||Clinical responders||-1.63|-26.15|0.027
71746559|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|-1.0||||0.928|TWO_SIDED|95.0|-24.02|21.97||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||21.97|-24.02|0.928
71746560|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|-2.5||||0.658|TWO_SIDED|95.0|-13.72|8.77||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||8.77|-13.72|0.658
71746561|NCT02365649|143002044|SUPERIORITY||LS Mean of Difference|-3.5||||0.601|TWO_SIDED|95.0|-16.96|9.96||P-value for test of difference between each upadacitinib higher dose and upadacitinib lower dose for mean change from induction baseline using analysis of covariance with treatment as factor and induction baseline value as covariate.|ANCOVA|||Clinical non-responders||9.96|-16.96|0.601
71746562|NCT02365649|143002046|SUPERIORITY||Risk Difference (RD)|-50.0||||1|TWO_SIDED|95.0|-99.0|-1.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-1.0|-99.0|1.000
71746563|NCT02365649|143002046|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
71746564|NCT02365649|143002046|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
71746565|NCT02365649|143002046|SUPERIORITY||Risk Difference (RD)|-25.0||||1|TWO_SIDED|95.0|-55.0|5.0||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical Responders||5.0|-55.0|1.000
71779675|NCT03345914|143059323|SUPERIORITY||Percentage difference|40.4|||<|0.0001|TWO_SIDED|95.0|28.95|51.82||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||51.82|28.95|< 0.0001
71779676|NCT03345914|143059323|SUPERIORITY||Percentage difference|42.8|||<|0.0001|TWO_SIDED|95.0|31.54|54.15||The Cochran-Mantel-Haenszel (CMH) test adjusted by randomization strata (baseline weight group (\< 30 kg or ≥ 30 kg) and region (North America or Europe) was used for the analysis of percentage of participants with EASI-75 at Week 16.|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||54.15|31.54|< 0.0001
71746566|NCT02365649|143002047|SUPERIORITY||Risk Difference (RD)|-66.7||||1|TWO_SIDED|95.0|-100.0|-13.3||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Responders||-13.3|-100.0|1.000
71746567|NCT02365649|143002047|SUPERIORITY||Risk Difference (RD)|33.3||||0.25|TWO_SIDED|95.0|-20.0|86.7||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Non-responders||86.7|-20.0|0.250
71746568|NCT02365649|143002047|SUPERIORITY||Risk Difference (RD)|16.7||||1|TWO_SIDED|95.0|-62.2|95.6||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||95.6|-62.2|1.000
71746569|NCT02365649|143002047|SUPERIORITY||Risk Difference (RD)|-33.3||||0.5|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|0.500
71746570|NCT02365649|143002047|SUPERIORITY||Risk Difference (RD)|-33.3||||1|TWO_SIDED|95.0|-71.1|4.4||P-value was calculated based on chi-square test (or Fisher's exact test if \>= 20% of the cells had expected cell count \< 5).|Chi-squared||Risk difference = (upadacitinib higher dose - upadacitinib 3 mg BID). 95% confidence intervals for risk difference were calculated based on normal approximation using proc FREQ.|Clinical responders||4.4|-71.1|1.000
71746571|NCT03865446|143002062|OTHER||Geometric Means Ratio|130.91|||||TWO_SIDED|90.0|86.03|199.22|||||The model was an analysis of variance (ANOVA) model with unequal variance assumption and hepatic impairment group as fixed effect. Values were back-transformed from the log scale.|||199.22|86.03|
71746572|NCT03865446|143002063|OTHER||Geometric Means Ratio|104.41|||||TWO_SIDED|90.0|72.12|151.16|||||The model was an ANOVA model with unequal variance assumption and hepatic impairment group as fixed effect. Values are back-transformed from the log scale.|||151.16|72.12|
71746573|NCT00965250|143002120|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
71746574|NCT00965250|143002121|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kaplan Meier|||||||<0.0001
71746575|NCT00479713|143002132|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|1.72|<=|0.001||95.0|-14.1|-7.33|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-7.33|-14.10|<=0.001
71746576|NCT00479713|143002133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<=|0.001||95.0|1.5|3.0|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 100 mg/dL (2.59 mmol/L)||3.0|1.5|<=0.001
71746577|NCT00479713|143002133|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|||<=|0.001||95.0|1.8|4.4|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of \< 70 mg/dL (1.81 mmol/L)||4.4|1.8|<=0.001
71746578|NCT00479713|143002134|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<=|0.001||95.0|-9.56|-4.84|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-4.84|-9.56|<=0.001
71746579|NCT00479713|143002135|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.06||||0.056||95.0|-9.56|-0.3|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval (CI) based on Wilcoxon's rank.|||-0.30|-9.56|0.056
71746580|NCT00479713|143002136|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|1.17||0.433||95.0|-3.21|1.38|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||1.38|-3.21|0.433
71891192|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.567
71746581|NCT00479713|143002137|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|STANDARD_ERROR_OF_MEAN|1.58|<=|0.001||95.0|-12.5|-6.31|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-6.31|-12.50|<=0.001
71746582|NCT00479713|143002138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.59|STANDARD_ERROR_OF_MEAN|1.98|<=|0.001||95.0|-13.49|-5.69|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-5.69|-13.49|<=0.001
71746583|NCT00479713|143002139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.25|STANDARD_ERROR_OF_MEAN|1.44|<=|0.001||95.0|-9.07|-3.43|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.||||-3.43|-9.07|<=0.001
71746584|NCT00479713|143002140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.11|STANDARD_ERROR_OF_MEAN|1.43|<=|0.001||95.0|-10.91|-5.3|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center||||-5.30|-10.91|<=0.001
71746585|NCT00479713|143002141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67||||0.172||95.0|-16.67|2.87|||Nonparametric ANOVA|ANOVA model based on Tukey's normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free CI based on Wilcoxon's rank|||2.87|-16.67|0.172
71746586|NCT00141102|143002142|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.32|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
71746587|NCT00141102|143002143|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||<0.0001
71746588|NCT00141102|143002144|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.4146|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.03|-0.06|0.4146
71746589|NCT00141102|143002145|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.1132|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.1132
71746590|NCT00141102|143002147|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.0495|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0495
71746591|NCT00141102|143002148|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.0006|TWO_SIDED||||||Life Table Extension|Stratified by history of GD ulceration and by region.||||||0.0006
71746592|NCT00141102|143002149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.36|0.45|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.45|0.36|<0.0001
71746593|NCT00141102|143002150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.118|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|0.98|1.25|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||1.25|0.98|<0.0001
71891193|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.383
71779677|NCT03345914|143059324|SUPERIORITY||Least Square Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-36.33|-23.24||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.24|-36.33|< 0.0001
71746594|NCT00141102|143002151|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.748|||<|0.0001|TWO_SIDED|95.0|1.96|3.84|||Cochran-Mantel-Haenszel|Stratified by history of GD ulceration and by region.||||3.84|1.96|<0.0001
71746595|NCT00141102|143002152|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|3.329|||<|0.0001|TWO_SIDED|95.0|2.156|5.141|||Fisher Exact|||GGT||5.141|2.156|<0.0001
71746596|NCT00141102|143002152|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|1.509||||0.3809|TWO_SIDED|95.0|0.618|3.684|||Fisher Exact|||AST||3.684|0.618|0.3809
71746597|NCT00141102|143002152|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.089||||0.0264|TWO_SIDED|95.0|1.081|4.038|||Fisher Exact|||ALT||4.038|1.081|0.0264
71779678|NCT03345914|143059324|SUPERIORITY||Least Square Mean Difference|-33.4|||<|0.0001|TWO_SIDED|95.0|-40.06|-26.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.82|-40.06|< 0.0001
71891194|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.963
71746598|NCT00141102|143002153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.144|STANDARD_ERROR_OF_MEAN|0.697|<|0.0001|TWO_SIDED|95.0|-11.51|-8.78|||ANCOVA|||GGT||-8.78|-11.51|<0.0001
71746599|NCT00141102|143002153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.391|STANDARD_ERROR_OF_MEAN|0.281|<|0.0001|TWO_SIDED|95.0|-2.94|-1.84|||ANCOVA|||AST||-1.84|-2.94|<0.0001
71746600|NCT00141102|143002153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.364|STANDARD_ERROR_OF_MEAN|0.428|<|0.0001|TWO_SIDED|95.0|-7.2|-5.52|||ANCOVA|||ALT||-5.52|-7.20|<0.0001
71891195|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.075
71779679|NCT03345914|143059325|SUPERIORITY||Least Square Mean Difference|-31.0|||<|0.0001|TWO_SIDED|95.0|-38.76|-23.26||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-23.26|-38.76|< 0.0001
71779680|NCT03345914|143059325|SUPERIORITY||Least Square Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-36.47|-20.82||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-20.82|-36.47|< 0.0001
71891196|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.854||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.854
71746601|NCT00141102|143002154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.565|STANDARD_ERROR_OF_MEAN|1.366||0.6795|TWO_SIDED|95.0|-2.11|3.24|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.24|-2.11|0.6795
71746602|NCT00141102|143002155|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.406|STANDARD_ERROR_OF_MEAN|2.624||0.592|TWO_SIDED|95.0|-6.55|3.74|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||3.74|-6.55|0.5920
71746603|NCT00141102|143002156|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.038||0.6819|TWO_SIDED|95.0|-0.09|0.06|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.||||0.06|-0.09|0.6819
71746604|NCT02831764|143002167|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|-0.7|||||TWO_SIDED|95.0|-4.3|2.9|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 copies per milliliter) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter \[cells/mm\^3\]).|||2.9|-4.3|
71746605|NCT02831764|143002168|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 24 was greater than -10%.|Adjusted difference in proportion|0.1|||||TWO_SIDED|95.0|-3.4|3.6|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||3.6|-3.4|
71746606|NCT02831764|143002169|OTHER||Adjusted difference in proportion|-1.8|||||TWO_SIDED|95.0|-6.4|2.7|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.7|-6.4|
71746607|NCT02831764|143002170|OTHER||Adjusted difference in proportion|0.0|||||TWO_SIDED|95.0|-5.3|5.3|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||5.3|-5.3|
71779681|NCT03345914|143059326|SUPERIORITY||Percentage difference|46.4|||<|0.0001|TWO_SIDED|95.0|35.3|57.42||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||57.42|35.3|< 0.0001
71666241|NCT04386616|142846801|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4913|TWO_SIDED|95.0|0.82|1.5|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.50|0.82|0.4913
71779682|NCT03345914|143059326|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|27.88|50.51||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.51|27.88|< 0.0001
71666242|NCT04386616|142846802|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.4711|TWO_SIDED|95.0|0.83|1.49|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.49|0.83|0.4711
71779683|NCT03345914|143059327|SUPERIORITY||Percentage difference|46.0|||<|0.0001|TWO_SIDED|95.0|35.47|56.61||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||56.61|35.47|< 0.0001
71779684|NCT03345914|143059327|SUPERIORITY||Percentage difference|38.5|||<|0.0001|TWO_SIDED|95.0|27.86|49.21||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||49.21|27.86|< 0.0001
71779685|NCT03345914|143059328|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|28.68|50.72||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||50.72|28.68|< 0.0001
71779686|NCT03345914|143059328|SUPERIORITY||Percentage difference|47.9|||<|0.0001|TWO_SIDED|95.0|37.77|58.01||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||58.01|37.77|< 0.0001
71779687|NCT03345914|143059329|SUPERIORITY||Percentage difference|23.0|||<|0.0001|TWO_SIDED|95.0|13.65|32.38||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||32.38|13.65|< 0.0001
71666243|NCT04386616|142846802|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.3135|TWO_SIDED|95.0|0.87|1.56|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.56|0.87|0.3135
71666244|NCT04386616|142846802|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5735|TWO_SIDED|95.0|0.81|1.48|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.48|0.81|0.5735
71779688|NCT03345914|143059329|SUPERIORITY||Percentage difference|34.5|||<|0.0001|TWO_SIDED|95.0|24.6|44.37||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||44.37|24.6|< 0.0001
71834916|NCT03092726|143174419|SUPERIORITY||LSM Difference|1.68|STANDARD_ERROR_OF_MEAN|2.43||0.755|TWO_SIDED|90.0|-2.34|5.69||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||5.69|-2.34|0.755
71834917|NCT03092726|143174420|SUPERIORITY||LSM Difference|0.19|STANDARD_ERROR_OF_MEAN|0.59||0.629|TWO_SIDED|90.0|-0.78|1.17||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.17|-0.78|0.629
71666245|NCT04386616|142846802|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5973|TWO_SIDED|95.0|0.8|1.46|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.46|0.80|0.5973
71666246|NCT04386616|142846803|SUPERIORITY||Median Difference (Net)|-1.0||||0.5304|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5304
71666247|NCT04386616|142846803|SUPERIORITY||Median Difference (Net)|-4.5||||0.5058|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.5058
71666248|NCT04386616|142846804|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8451|TWO_SIDED|95.0|0.64|1.72|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.72|0.64|0.8451
71666249|NCT04386616|142846804|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7267|TWO_SIDED|95.0|0.67|1.79|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.79|0.67|0.7267
71666250|NCT04386616|142846804|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8458|TWO_SIDED|95.0|0.63|1.79|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.79|0.63|0.8458
71666251|NCT04386616|142846804|SUPERIORITY||Odds Ratio (OR)|1.08||||0.7907|TWO_SIDED|95.0|0.64|1.81|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.81|0.64|0.7907
71666252|NCT04386616|142846805|SUPERIORITY||Median Difference (Final Values)|0.0||||0.5273|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.5273
71666253|NCT04386616|142846805|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6515|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.6515
71666254|NCT04386616|142846805|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5475|TWO_SIDED|95.0|0.71|1.91|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.91|0.71|0.5475
71666255|NCT04386616|142846805|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5652|TWO_SIDED|95.0|0.71|1.89|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.89|0.71|0.5652
71666256|NCT04386616|142846806|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3401|||||||Van Elteren||The median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.3401
71666257|NCT04386616|142846806|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4676|||||||Van Elteren||The median difference was calculated as the UTT1147A Arm minus the Placebo Arm.|||||0.4676
71666258|NCT04386616|142846806|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3408|TWO_SIDED|95.0|0.75|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.29|0.75|0.3408
71666259|NCT04386616|142846806|SUPERIORITY||Odds Ratio (OR)|1.32||||0.332|TWO_SIDED|95.0|0.76|2.29|||Proportional Odds Model|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.29|0.76|0.3320
71666260|NCT04386616|142846807|SUPERIORITY||Difference in percentage of participants|3.83|||||TWO_SIDED|95.0|-7.57|15.24|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||15.24|-7.57|
71666261|NCT04386616|142846807|SUPERIORITY||Difference in percentage of participants|-0.38|||||TWO_SIDED|95.0|-11.46|10.7|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.70|-11.46|
71666262|NCT04386616|142846807|SUPERIORITY||Odds Ratio (OR)|1.22||||0.4804|TWO_SIDED|95.0|0.7|2.1|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.10|0.70|0.4804
71746608|NCT02831764|143002171|OTHER||Hazard Ratio (HR)|1.02||||0.797|TWO_SIDED|95.0|0.88|1.19||The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalised Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.19|0.88|0.797
71891197|NCT00190775|143304297|SUPERIORITY_OR_OTHER|||||||0.671||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.671
71666263|NCT04386616|142846807|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9418|TWO_SIDED|95.0|0.56|1.71|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.71|0.56|0.9418
71666264|NCT04386616|142846807|SUPERIORITY||Odds Ratio (OR)|1.29||||0.4988|TWO_SIDED|95.0|0.68|2.44|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.44|0.68|0.4988
71666265|NCT04386616|142846807|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9043|TWO_SIDED|95.0|0.54|1.96|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.96|0.54|0.9043
71666266|NCT04386616|142846808|SUPERIORITY||Median Difference (Net)|0.0||||0.8007|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.8007
71666267|NCT04386616|142846808|SUPERIORITY||Median Difference (Net)|0.0||||0.8633|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.8633
71666268|NCT04386616|142846809|SUPERIORITY||Difference in percentage of participants|-3.59|||||TWO_SIDED|95.0|-16.31|9.12|||||The difference in percentage of participants was calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.12|-16.31|
71666269|NCT04386616|142846809|SUPERIORITY||Difference in percentage of participants|-12.0|||||TWO_SIDED|95.0|-24.67|0.67|||||The difference in percentage of participants was calculated as the UTTR1147A Arm minus the Placebo Arm.|||0.67|-24.67|
71891198|NCT00190775|143304298|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.280
71891199|NCT00190775|143304298|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.34
71746609|NCT02831764|143002175|OTHER||Mean Difference (Net)|25.6||||0.043|TWO_SIDED|95.0|0.8|50.4|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||50.4|0.8|0.043
71746610|NCT02831764|143002175|OTHER||Mean Difference (Net)|8.5||||0.523|TWO_SIDED|95.0|-17.7|34.8|||MMRM||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||34.8|-17.7|0.523
71746611|NCT02831764|143002176|OTHER||Mean Difference (Net)|7.4||||0.635|TWO_SIDED|95.0|-23.2|38.0|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||38.0|-23.2|0.635
71746612|NCT02831764|143002177|OTHER||Mean Difference (Net)|5.1||||0.777|TWO_SIDED|95.0|-29.9|40.0|||MMRM||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||40.0|-29.9|0.777
71746613|NCT02831764|143002188|OTHER||Mean Difference (Net)|-0.03|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02|||MMRM||Week 24. Serum Cystatin C.|||-0.02|-0.05|<0.001
71746614|NCT02831764|143002188|OTHER||Mean Difference (Net)|-0.02||||0.022|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 48. Serum Cystatin C.|||0.00|-0.03|0.022
71746615|NCT02831764|143002188|OTHER||Mean Difference (Net)|-0.2||||0.797|TWO_SIDED|95.0|-1.4|1.1|||MMRM||Week 24. Serum RBP|||1.1|-1.4|0.797
71746616|NCT02831764|143002188|OTHER||Mean Difference (Net)|0.7||||0.258|TWO_SIDED|95.0|-0.5|1.9|||MMRM||Week 48. Serum RBP|||1.9|-0.5|0.258
71746617|NCT02831764|143002189|OTHER||Mean Difference (Net)|-0.02||||0.034|TWO_SIDED|95.0|-0.03|0.0|||MMRM||Week 96. Serum Cystatin C.|||0.00|-0.03|0.034
71746618|NCT02831764|143002190|OTHER||Mean Difference (Net)|-0.02||||0.006|TWO_SIDED|95.0|-0.04|-0.01|||MMRM||Week 144. Serum Cystatin C.|||-0.01|-0.04|0.006
71746619|NCT02831764|143002193|OTHER||Mean Difference (Net)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|5.4|||MMRM||Week 24. GFR Cystatin C adjusted.|||5.4|1.8|<0.001
71834918|NCT03092726|143174420|SUPERIORITY||LSM Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.73||0.41|TWO_SIDED|90.0|-1.37|1.04||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.04|-1.37|0.410
71891200|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.103
71746620|NCT02831764|143002193|OTHER||Mean Difference (Net)|1.7||||0.056|TWO_SIDED|95.0|0.0|3.5|||MMRM||Week 48. GFR Cystatin C adjusted.|||3.5|0.0|0.056
71746621|NCT02831764|143002193|OTHER||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|1.7|5.2|||MMRM||Week 24. GFR creatinine adjusted.|||5.2|1.7|<0.001
71746622|NCT02831764|143002193|OTHER||Mean Difference (Net)|3.3|||<|0.001|TWO_SIDED|95.0|1.6|5.0|||MMRM||Week 48. GFR creatinine adjusted.|||5.0|1.6|<0.001
71746623|NCT02831764|143002196|OTHER||Mean Difference (Net)|-3.02|||<|0.001|TWO_SIDED|95.0|-4.49|-1.55|||MMRM||Week 24. Serum or Plasma Creatinine|||-1.55|-4.49|<0.001
71746624|NCT02831764|143002196|OTHER||Mean Difference (Net)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.59|-1.65|||MMRM||Week 48. Serum or Plasma creatinine|||-1.65|-4.59|<0.001
71746625|NCT02831764|143002197|OTHER||Mean Difference (Net)|-3.04|||<|0.001|TWO_SIDED|95.0|-4.56|-1.53|||MMRM||Week 96. Serum or Plasma creatinine|||-1.53|-4.56|<0.001
71746626|NCT02831764|143002198|OTHER||Mean Difference (Net)|-2.86|||<|0.001|TWO_SIDED|95.0|-4.52|-1.19|||MMRM||Week 144. Serum or Plasma creatinine|||-1.19|-4.52|<0.001
71746627|NCT02831764|143002199|OTHER||Ratio of geometric means|0.917|||<|0.001|TWO_SIDED|95.0|0.893|0.941|||MMRM||Week 24. Serum B2M.|||0.941|0.893|<0.001
71746628|NCT02831764|143002199|OTHER||Ratio of geometric means|0.914|||<|0.001|TWO_SIDED|95.0|0.89|0.939|||MMRM||Week 48. Serum B2M.|||0.939|0.890|<0.001
71746629|NCT02831764|143002199|OTHER||Ratio of geometric means|0.748||||0.002|TWO_SIDED|95.0|0.621|0.901|||MMRM||Week 24. Urine B2M.|||0.901|0.621|0.002
71746630|NCT02831764|143002199|OTHER||Ratio of geometric means|0.693||||0.005|TWO_SIDED|95.0|0.538|0.892|||MMRM||Week 48. Urine B2M.|||0.892|0.538|0.005
71746631|NCT02831764|143002199|OTHER||Ratio of geometric means|0.889||||0.036|TWO_SIDED|95.0|0.796|0.992|||MMRM||Week 24. Urine Albumin/Creatinine.|||0.992|0.796|0.036
71746632|NCT02831764|143002199|OTHER||Ratio of geometric means|0.938||||0.308|TWO_SIDED|95.0|0.83|1.061|||MMRM||Week 48. Urine Albumin/Creatinine.|||1.061|0.830|0.308
71746633|NCT02831764|143002199|OTHER||Ratio of geometric means|0.781||||0.007|TWO_SIDED|95.0|0.654|0.934|||MMRM||Week 24. Urine B2M/Urine Creatinine.|||0.934|0.654|0.007
71746634|NCT02831764|143002199|OTHER||Ratio of geometric means|0.742||||0.012|TWO_SIDED|95.0|0.588|0.935|||MMRM||Week 48. Urine B2M/Urine Creatinine.|||0.935|0.588|0.012
71746635|NCT02831764|143002199|OTHER||Ratio of geometric means|0.979||||0.728|TWO_SIDED|95.0|0.868|1.104|||MMRM||Week 24. Urine Phosphate.|||1.104|0.868|0.728
71746636|NCT02831764|143002199|OTHER||Ratio of geometric means|1.062||||0.311|TWO_SIDED|95.0|0.945|1.194|||MMRM||Week 48. Urine Phosphate.|||1.194|0.945|0.311
71746637|NCT02831764|143002199|OTHER||Ratio of geometric means|0.826|||<|0.001|TWO_SIDED|95.0|0.769|0.887|||MMRM||Week 24. Urine Protein/Creatinine.|||0.887|0.769|<0.001
71746638|NCT02831764|143002199|OTHER||Ratio of geometric means|0.86|||<|0.001|TWO_SIDED|95.0|0.795|0.93|||MMRM||Week 48. Urine Protein/Creatinine.|||0.930|0.795|<0.001
71746639|NCT02831764|143002199|OTHER||Ratio of geometric means|0.796||||0.003|TWO_SIDED|95.0|0.683|0.927|||MMRM||Week 24. Urine RBP 4|||0.927|0.683|0.003
71746640|NCT02831764|143002199|OTHER||Ratio of geometric means|0.903||||0.2|TWO_SIDED|95.0|0.773|1.056|||MMRM||Week 48. Urine RBP 4|||1.056|0.773|0.200
71746641|NCT02831764|143002199|OTHER||Ratio of geometric means|0.826||||0.003|TWO_SIDED|95.0|0.728|0.936|||MMRM||Week 24. Urine RBP 4/Urine Creatinine|||0.936|0.728|0.003
71834919|NCT03092726|143174420|SUPERIORITY||LSM Difference|0.06|STANDARD_ERROR_OF_MEAN|0.71||0.531|TWO_SIDED|90.0|-1.11|1.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.||1.22|-1.11|0.531
71834920|NCT03092726|143174420|SUPERIORITY||LSM Difference|0.17|STANDARD_ERROR_OF_MEAN|0.67||0.603|TWO_SIDED|90.0|-0.93|1.28||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.||1.28|-0.93|0.603
71834921|NCT03092726|143174421|SUPERIORITY||Odds Ratio (OR)|1.07||||0.811|TWO_SIDED|90.0|0.68|1.67||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 2: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.67|0.68|0.811
71834922|NCT03092726|143174421|SUPERIORITY||Odds Ratio (OR)|0.79||||0.368|TWO_SIDED|90.0|0.5|1.22||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 4: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.22|0.50|0.368
71834923|NCT03092726|143174421|SUPERIORITY||Odds Ratio (OR)|0.78||||0.357|TWO_SIDED|90.0|0.5|1.21||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 8: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.21|0.50|0.357
71834924|NCT03092726|143174421|SUPERIORITY||Odds Ratio (OR)|0.8||||0.407|TWO_SIDED|90.0|0.52|1.24||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||EOT: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.||1.24|0.52|0.407
71834925|NCT04950127|143174422|SUPERIORITY||Mean Difference (Net)|-0.72||||0.001|TWO_SIDED|95.0|-1.15|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly Itch score (MIS), Visit\*Baseline MIS interaction, Baseline Concomitant Itch Medication.||-0.28|-1.15|0.001
71834926|NCT04950127|143174423|SUPERIORITY||Mean Difference (Net)|-0.71|||<|0.001|TWO_SIDED|95.0|-1.07|-0.34||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Week, Week\*Treatment Group interaction, Baseline Weekly Itch score (WIS), Visit\*Baseline WIS interaction, Baseline Concomitant Itch Medication.||-0.34|-1.07|<0.001
71666270|NCT04386616|142846809|SUPERIORITY||Odds Ratio (OR)|0.86||||0.556|TWO_SIDED|95.0|0.53|1.41|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.41|0.53|0.5560
71746642|NCT02831764|143002199|OTHER||Ratio of geometric means|0.888||||0.052|TWO_SIDED|95.0|0.787|1.001|||MMRM||Week 48. Urine RBP 4/Urine Creatinine|||1.001|0.787|0.052
71834927|NCT04950127|143174424|SUPERIORITY||Mean Difference (Net)|-0.53||||0.024|TWO_SIDED|95.0|-0.98|-0.07||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Monthly sleep score (MSS), Visit\*Baseline MSS interaction, Baseline Concomitant Itch Medication.||-0.07|-0.98|0.024
71834928|NCT04950127|143174425|SUPERIORITY||Percentage difference|4.0||||0.539||95.0|-9.0|17.0||Adjusted for multiplicity as per Statistical Analysis Plan (SAP)|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and less than \[\<\]7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains Bile Acid Binding Resin \[BABR\], Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||17.0|-9.0|0.539
71834929|NCT04950127|143174426|SUPERIORITY||Percentage Difference|13.0||||0.043|TWO_SIDED|95.0|0.0|27.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||27.0|0.0|0.043
71834930|NCT04950127|143174427|SUPERIORITY||Percentage Difference|12.0||||0.058|TWO_SIDED|95.0|0.0|24.0||Adjusted for multiplicity; two-sided p-values \<0.05 were considered to be nominally significant as per SAP.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) stratified analysis adjusted for baseline factors: Baseline Itch Severity (Moderate: \>=4 and \<7, Severe: \>=7); Concomitant cholestatic pruritus treatment regimen (Regimen contains BABR, Regimen does not contain BABR, No defined treatment). Multiple imputation of missing Monthly itch scores was done before deriving responder definitions. Imputed datasets were analyzed using the CMH method and combined.||24.0|-0.0|0.058
71666271|NCT04386616|142846809|SUPERIORITY||Odds Ratio (OR)|0.62||||0.0502|TWO_SIDED|95.0|0.38|1.0|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.00|0.38|0.0502
71746643|NCT02831764|143002200|OTHER||Ratio of geometric means|0.942||||0.338|TWO_SIDED|95.0|0.833|1.065|||MMRM||Week 96. Urine Albumin/Creatinine.|||1.065|0.833|0.338
71746644|NCT02831764|143002200|OTHER||Ratio of geometric means|0.671|||<|0.001|TWO_SIDED|95.0|0.545|0.826|||MMRM||Week 96. Urine B2M/Urine Creatinine.|||0.826|0.545|<0.001
71746645|NCT02831764|143002200|OTHER||Ratio of geometric means|1.082||||0.174|TWO_SIDED|95.0|0.966|1.213|||MMRM||Week 96. Urine Phosphate.|||1.213|0.966|0.174
71666272|NCT04386616|142846809|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7002|TWO_SIDED|95.0|0.51|1.6|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.60|0.51|0.7002
71666273|NCT04386616|142846809|SUPERIORITY||Odds Ratio (OR)|0.57||||0.0448|TWO_SIDED|95.0|0.32|0.99|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||0.99|0.32|0.0448
71746646|NCT02831764|143002200|OTHER||Ratio of geometric means|0.873|||<|0.001|TWO_SIDED|95.0|0.806|0.946|||MMRM||Week 96. Urine Protein/Creatinine.|||0.946|0.806|<0.001
71746647|NCT02831764|143002200|OTHER||Ratio of geometric means|0.8|||<|0.001|TWO_SIDED|95.0|0.716|0.894|||MMRM||Week 96. Urine RBP 4/Urine Creatinine|||0.894|0.716|<0.001
71746648|NCT02831764|143002201|OTHER||Ratio of geometric means|0.971||||0.658|TWO_SIDED|95.0|0.852|1.107|||MMRM||Week 144. Urine Albumin/Creatinine.|||1.107|0.852|0.658
71746649|NCT02831764|143002201|OTHER||Ratio of geometric means|0.584|||<|0.001|TWO_SIDED|95.0|0.483|0.706|||MMRM||Week 144. Urine B2M/Urine Creatinine.|||0.706|0.483|<0.001
71779689|NCT03345914|143059330|SUPERIORITY||Hazard ratios|3.114|||<|0.0001|TWO_SIDED|95.0|2.097|4.624||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.624|2.097|< 0.0001
71779690|NCT03345914|143059330|SUPERIORITY||Hazard ratios|2.921|||<|0.0001|TWO_SIDED|95.0|1.957|4.36||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||4.36|1.957|< 0.0001
71779691|NCT03345914|143059331|SUPERIORITY||Hazard ratios|2.278|||<|0.0001|TWO_SIDED|95.0|1.631|3.182||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||3.182|1.631|< 0.0001
71834931|NCT04950127|143174428|SUPERIORITY|Cognitive|Mean Difference (Net)|0.76||||0.176|TWO_SIDED|95.0|-0.34|1.86||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.86|-0.34|0.176
71891201|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.182
71891202|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.161
71666274|NCT04386616|142846810|SUPERIORITY||Median Difference (Net)|-0.48||||0.4845|||||||Van Elteren||Median difference was calculated as the MSTT1041A Arm minus the Placebo Arm.|||||0.4845
71666275|NCT04386616|142846810|SUPERIORITY||Median Difference (Net)|-3.1||||0.057|||||||Van Elteren||Median difference was calculated as the UTTR1147A Arm minus the Placebo Arm.|||||0.0570
71666276|NCT04386616|142846811|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.4456|TWO_SIDED|95.0|0.76|1.88|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.88|0.76|0.4456
71666277|NCT04386616|142846811|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7213|TWO_SIDED|95.0|0.57|1.48|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.48|0.57|0.7213
71666278|NCT04386616|142846811|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.3963|TWO_SIDED|95.0|0.77|1.96|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||1.96|0.77|0.3963
71666279|NCT04386616|142846811|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9174|TWO_SIDED|95.0|0.6|1.58|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||1.58|0.60|0.9174
71666280|NCT04386616|142846812|OTHER||Difference in Mortality Rates|2.49|||||TWO_SIDED|95.0|-4.51|9.49|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||9.49|-4.51|
71746650|NCT02831764|143002201|OTHER||Ratio of geometric means|1.0||||0.993|TWO_SIDED|95.0|0.892|1.12|||MMRM||Week 144. Urine Phosphate.|||1.120|0.892|0.993
71746651|NCT02831764|143002201|OTHER||Ratio of geometric means|0.847|||<|0.001|TWO_SIDED|95.0|0.785|0.913|||MMRM||Week 144. Urine Protein/Creatinine.|||0.913|0.785|<0.001
71746652|NCT02831764|143002201|OTHER||Ratio of geometric means|0.739|||<|0.001|TWO_SIDED|95.0|0.667|0.819|||MMRM||Week 144. Urine RBP 4/Urine Creatinine|||0.819|0.667|<0.001
71746653|NCT02831764|143002202|OTHER||Mean Difference (Net)|-2.66|||<|0.001|TWO_SIDED|95.0|-3.25|-2.08|||MMRM||Week 24, Bone ALP|||-2.08|-3.25|<0.001
71746654|NCT02831764|143002202|OTHER||Mean Difference (Net)|-3.09|||<|0.001|TWO_SIDED|95.0|-3.75|-2.44|||MMRM||Week 48, Bone ALP|||-2.44|-3.75|<0.001
71746655|NCT02831764|143002202|OTHER||Mean Difference (Net)|-4.67|||<|0.001|TWO_SIDED|95.0|-5.63|-3.71|||MMRM||Week 28, Serum Osteocalcin|||-3.71|-5.63|<0.001
71746656|NCT02831764|143002202|OTHER||Mean Difference (Net)|-5.9|||<|0.001|TWO_SIDED|95.0|-6.89|-4.91|||MMRM||Week 48, Serum Osteocalcin|||-4.91|-6.89|<0.001
71746657|NCT02831764|143002202|OTHER||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-16.4|-10.6|||MMRM||Week 24, Serum PINP|||-10.6|-16.4|<0.001
71746658|NCT02831764|143002202|OTHER||Mean Difference (Net)|-12.8|||<|0.001|TWO_SIDED|95.0|-15.4|-10.2|||MMRM||Week 48, Serum PINP|||-10.2|-15.4|<0.001
71666281|NCT04386616|142846812|OTHER||Difference in Mortality Rates|2.36|||||TWO_SIDED|95.0|-4.58|9.31|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||9.31|-4.58|
71746659|NCT02831764|143002202|OTHER||Mean Difference (Net)|-0.127|||<|0.001|TWO_SIDED|95.0|-0.164|-0.09|||MMRM||Week 24, CTX-1|||-0.0900|-0.1640|<0.001
71746660|NCT02831764|143002202|OTHER||Mean Difference (Net)|-0.2043|||<|0.001|TWO_SIDED|95.0|-0.2532|-0.1554|||MMRM||Week 48, CTX-1|||-0.1554|-0.2532|<0.001
71746661|NCT02831764|143002203|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.72|-1.54|||MMRM||Week 96, Bone ALP|||-1.54|-2.72|<0.001
71746662|NCT02831764|143002203|OTHER||Mean Difference (Net)|-3.77|||<|0.001|TWO_SIDED|95.0|-4.69|-2.85|||MMRM||Week 96, Serum Osteocalcin|||-2.85|-4.69|<0.001
71746663|NCT02831764|143002203|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-16.8|-8.3|||MMRM||Week 96, Serum PINP|||-8.3|-16.8|<0.001
71746664|NCT02831764|143002203|OTHER||Mean Difference (Net)|-0.1183|||<|0.001|TWO_SIDED|95.0|-0.1529|-0.0838|||MMRM||Week 96, CTX-1|||-0.0838|-0.1529|<0.001
71746665|NCT02831764|143002204|OTHER||Mean Difference (Net)|-2.13|||<|0.001|TWO_SIDED|95.0|-2.74|-1.53|||MMRM||Week 144, Bone ALP|||-1.53|-2.74|<0.001
71746666|NCT02831764|143002204|OTHER||Mean Difference (Net)|-3.89|||<|0.001|TWO_SIDED|95.0|-4.87|-2.91|||MMRM||Week 144, Serum Osteocalcin|||-2.91|-4.87|<0.001
71779692|NCT03345914|143059331|SUPERIORITY||Hazard ratios|2.075|||<|0.0001|TWO_SIDED|95.0|1.481|2.908||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cox model|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.908|1.481|< 0.0001
71779693|NCT03345914|143059332|SUPERIORITY||Least Square Mean Difference|-17.72|||<|0.0001|TWO_SIDED|95.0|-22.272|-13.161||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-13.161|-22.272|< 0.0001
71834932|NCT04950127|143174428|SUPERIORITY|Emotional|Mean Difference (Net)|0.27||||0.403|TWO_SIDED|95.0|-0.36|0.89||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.89|-0.36|0.403
71666282|NCT04386616|142846812|SUPERIORITY||Odds Ratio (OR)|1.46||||0.4336|TWO_SIDED|95.0|0.57|3.74|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.74|0.57|0.4336
71666283|NCT04386616|142846812|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4543|TWO_SIDED|95.0|0.56|3.68|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||3.68|0.56|0.4543
71666284|NCT04386616|142846812|SUPERIORITY||Odds Ratio (OR)|1.46||||0.49|TWO_SIDED|95.0|0.54|3.97|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||3.97|0.54|0.4900
71746667|NCT02831764|143002204|OTHER||Mean Difference (Net)|-9.5|||<|0.001|TWO_SIDED|95.0|-12.8|-6.2|||MMRM||Week 144, Serum PINP|||-6.2|-12.8|<0.001
71746668|NCT02831764|143002204|OTHER||Mean Difference (Net)|-0.1364|||<|0.001|TWO_SIDED|95.0|-0.1739|-0.0988|||MMRM||Week 144, CTX-1|||-0.0988|-0.1739|<0.001
71746669|NCT02831764|143002205|OTHER||Mean Difference (Net)|-4.2||||0.015|TWO_SIDED|95.0|-7.5|-0.8|||MMRM||Week 24|||-0.8|-7.5|0.015
71746670|NCT02831764|143002205|OTHER||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.8|2.6|||MMRM||Week 48|||2.6|-2.8|0.960
71746671|NCT02831764|143002206|OTHER||Mean Difference (Net)|-3.0||||0.048|TWO_SIDED|95.0|-5.9|0.0|||MMRM||Week 96, Serum Vitamin D|||0.0|-5.9|0.048
71746672|NCT02831764|143002207|OTHER||Mean Difference (Net)|-0.2||||0.887|TWO_SIDED|95.0|-3.6|3.1|||MMRM||Week 144, Serum Vitamin D|||3.1|-3.6|0.887
71746673|NCT02831764|143002214|OTHER||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.5|5.6|||Fisher Exact||Week 24|||5.6|1.5|<0.001
71746674|NCT02831764|143002214|OTHER||Mean Difference (Final Values)|2.8||||0.037|TWO_SIDED|95.0|0.2|5.4|||Fisher Exact||Week 48|||5.4|0.2|0.037
71746675|NCT02831764|143002215|OTHER||Mean Difference (Final Values)|3.1||||0.045|TWO_SIDED|95.0|0.2|6.1|||Fisher Exact||Week 96|||6.1|0.2|0.045
71746676|NCT02831764|143002216|OTHER||Mean Difference (Final Values)|2.6||||0.16|TWO_SIDED|95.0|-0.8|6.0|||Fisher Exact||Week 144|||6.0|-0.8|0.160
71746677|NCT02831764|143002221|OTHER||Mean Difference (Net)|37.8|||||TWO_SIDED|95.0|9.98|65.62|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||65.62|9.98|
71746678|NCT02831764|143002221|OTHER||Mean Difference (Net)|-26.81|||||TWO_SIDED|95.0|-82.72|29.1|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||29.10|-82.72|
71746679|NCT02831764|143002221|OTHER||Mean Difference (Net)|61.72|||||TWO_SIDED|95.0|-26.94|150.39|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||150.39|-26.94|
71746680|NCT02831764|143002221|OTHER||Mean Difference (Net)|22.57|||||TWO_SIDED|95.0|-3.42|48.55|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||48.55|-3.42|
71746681|NCT02831764|143002221|OTHER||Mean Difference (Net)|38.99|||||TWO_SIDED|95.0|5.88|72.09|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||72.09|5.88|
71746682|NCT02831764|143002221|OTHER||Mean Difference (Net)|-9.9|||||TWO_SIDED|95.0|-53.1|33.3|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||33.30|-53.10|
71746683|NCT02831764|143002221|OTHER||Mean Difference (Net)|65.53|||||TWO_SIDED|95.0|-14.43|145.5|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||145.50|-14.43|
71746684|NCT02831764|143002221|OTHER||Mean Difference (Net)|59.66|||||TWO_SIDED|95.0|-8.62|127.94|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||127.94|-8.62|
71746685|NCT02831764|143002221|OTHER||Mean Difference (Net)|19.23|||||TWO_SIDED|95.0|-7.65|46.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.10|-7.65|
71746686|NCT02831764|143002221|OTHER||Mean Difference (Net)|19.04|||||TWO_SIDED|95.0|-11.06|49.13|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||49.13|-11.06|
71746687|NCT02831764|143002221|OTHER||Mean Difference (Net)|43.25|||||TWO_SIDED|95.0|-30.59|117.09|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||117.09|-30.59|
71746688|NCT02831764|143002221|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-72.14|97.73|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||97.73|-72.14|
71746689|NCT02831764|143002221|OTHER||Mean Difference (Net)|62.01|||||TWO_SIDED|95.0|-16.09|140.12|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||140.12|-16.09|
71891203|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.472
71746690|NCT02831764|143002222|OTHER||Mean Difference (Net)|6.9|||||TWO_SIDED|95.0|-22.7|36.6|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||36.6|-22.7|
71746691|NCT02831764|143002222|OTHER||Mean Difference (Net)|13.2|||||TWO_SIDED|95.0|-46.8|73.2|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||73.2|-46.8|
71779694|NCT03345914|143059332|SUPERIORITY||Least Square Mean Difference|-18.88|||<|0.0001|TWO_SIDED|95.0|-23.479|-14.289||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-14.289|-23.479|< 0.0001
71891204|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.949
71666285|NCT04386616|142846812|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3595|TWO_SIDED|95.0|0.58|4.28|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||4.28|0.58|0.3595
71746692|NCT02831764|143002222|OTHER||Mean Difference (Net)|57.7|||||TWO_SIDED|95.0|-37.2|152.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||152.5|-37.2|
71746693|NCT02831764|143002222|OTHER||Mean Difference (Net)|4.1|||||TWO_SIDED|95.0|-23.5|31.7|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||31.7|-23.5|
71746694|NCT02831764|143002222|OTHER||Mean Difference (Net)|32.5|||||TWO_SIDED|95.0|-2.7|67.7|||||Age Group-1,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||67.7|-2.7|
71746695|NCT02831764|143002222|OTHER||Mean Difference (Net)|-31.5|||||TWO_SIDED|95.0|-77.1|14.2|||||Age Group-1,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||14.2|-77.1|
71746696|NCT02831764|143002222|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-81.4|91.8|||||Age Group-1,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.8|-81.4|
71746697|NCT02831764|143002222|OTHER||Mean Difference (Net)|8.6|||||TWO_SIDED|95.0|-19.4|36.5|||||Age Group-2, \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||36.5|-19.4|
71746698|NCT02831764|143002222|OTHER||Mean Difference (Net)|4.5|||||TWO_SIDED|95.0|-82.3|91.3|||||Age Group-2, \>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||91.3|-82.3|
71746699|NCT02831764|143002222|OTHER||Mean Difference (Net)|-27.3|||||TWO_SIDED|95.0|-100.8|46.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.1|-100.8|
71746700|NCT02831764|143002222|OTHER||Mean Difference (Net)|12.8|||||TWO_SIDED|95.0|-15.7|41.2|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||41.2|-15.7|
71746701|NCT02831764|143002222|OTHER||Mean Difference (Net)|11.3|||||TWO_SIDED|95.0|-20.4|43.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||43.1|-20.4|
71746702|NCT02831764|143002222|OTHER||Mean Difference (Net)|-37.8|||||TWO_SIDED|95.0|-119.6|44.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||44.0|-119.6|
71746703|NCT02831764|143002222|OTHER||Mean Difference (Net)|15.6|||||TWO_SIDED|95.0|-74.4|105.7|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||105.7|-74.4|
71746704|NCT02831764|143002222|OTHER||Mean Difference (Net)|37.6|||||TWO_SIDED|95.0|-45.4|120.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||120.5|-45.4|
71746705|NCT02831764|143002223|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-34.1|35.0|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||35.0|-34.1|
71746706|NCT02831764|143002223|OTHER||Mean Difference (Net)|14.7|||||TWO_SIDED|95.0|-55.6|84.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||84.9|-55.6|
71746707|NCT02831764|143002223|OTHER||Mean Difference (Net)|26.5|||||TWO_SIDED|95.0|-87.3|140.3|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||140.3|-87.3|
71746708|NCT02831764|143002223|OTHER||Mean Difference (Net)|2.8|||||TWO_SIDED|95.0|-29.4|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-29.4|
71746709|NCT02831764|143002223|OTHER||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|-32.5|49.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.1|-32.5|
71746710|NCT02831764|143002223|OTHER||Mean Difference (Net)|-13.3|||||TWO_SIDED|95.0|-67.6|41.1|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||41.1|-67.6|
71746711|NCT02831764|143002223|OTHER||Mean Difference (Net)|32.7|||||TWO_SIDED|95.0|-68.5|133.9|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||133.9|-68.5|
71746712|NCT02831764|143002223|OTHER||Mean Difference (Net)|5.1|||||TWO_SIDED|95.0|-80.7|90.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||90.8|-80.7|
71746713|NCT02831764|143002223|OTHER||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-31.1|35.3|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||35.3|-31.1|
71746714|NCT02831764|143002223|OTHER||Mean Difference (Net)|13.7|||||TWO_SIDED|95.0|-23.2|50.6|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||50.6|-23.2|
71779695|NCT03345914|143059333|SUPERIORITY||Least Square Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.3|-24.48||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-24.48|-36.3|< 0.0001
71813058|NCT05674890|143128456|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-0.29|STANDARD_DEVIATION|2.49||0.297|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||0.297
71746715|NCT02831764|143002223|OTHER||Mean Difference (Net)|-57.4|||||TWO_SIDED|95.0|-155.3|40.4|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||40.4|-155.3|
71746716|NCT02831764|143002223|OTHER||Mean Difference (Net)|-40.1|||||TWO_SIDED|95.0|-144.2|64.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||64.0|-144.2|
71746717|NCT02831764|143002223|OTHER||Mean Difference (Net)|33.1|||||TWO_SIDED|95.0|-63.3|129.6|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.6|-63.3|
71746718|NCT02831764|143002224|OTHER||Mean Difference (Net)|9.1|||||TWO_SIDED|95.0|-31.1|49.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||49.2|-31.1|
71746719|NCT02831764|143002224|OTHER||Mean Difference (Net)|-16.6|||||TWO_SIDED|95.0|-98.9|65.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||65.8|-98.9|
71746720|NCT02831764|143002224|OTHER||Mean Difference (Net)|56.0|||||TWO_SIDED|95.0|-77.2|189.1|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||189.1|-77.2|
71746721|NCT02831764|143002224|OTHER||Mean Difference (Net)|2.4|||||TWO_SIDED|95.0|-35.2|39.9|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||39.9|-35.2|
71666286|NCT04386616|142846813|OTHER||Difference in Mortality Rates|3.42|||||TWO_SIDED|95.0|-5.42|12.26|||||The difference in mortality rates is calculated as the MSTT1041A Arm minus the Placebo Arm.|||12.26|-5.42|
71746722|NCT02831764|143002224|OTHER||Mean Difference (Net)|25.8|||||TWO_SIDED|95.0|-22.3|74.0|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||74.0|-22.3|
71779696|NCT03345914|143059333|SUPERIORITY||Least Square Mean Difference|-32.6|||<|0.0001|TWO_SIDED|95.0|-38.57|-26.59||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-26.59|-38.57|< 0.0001
71779697|NCT03345914|143059334|SUPERIORITY||Least Square Mean Difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-5.62|-2.99||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.99|-5.62|< 0.0001
71779698|NCT03345914|143059334|SUPERIORITY||Least Square Mean Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.89||The confidence interval (CI) with p-value was based on treatment difference (dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.89|-5.57|< 0.0001
71779699|NCT03345914|143059335|SUPERIORITY||Least Square Mean Difference|-8.1|||<|0.0001|TWO_SIDED|95.0|-9.96|-6.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.31|-9.96|< 0.0001
71779700|NCT03345914|143059335|SUPERIORITY||Least Square Mean Difference|-8.3|||<|0.0001|TWO_SIDED|95.0|-10.13|-6.43||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-6.43|-10.13|< 0.0001
71779701|NCT03345914|143059336|SUPERIORITY||Least Square Mean Difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.984|-1.831||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.831|-2.984|< 0.0001
71779702|NCT03345914|143059336|SUPERIORITY||Least Square Mean Difference|-2.18|||<|0.0001|TWO_SIDED|95.0|-2.754|-1.599||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-1.599|-2.754|< 0.0001
71891205|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.848
71746723|NCT02831764|143002224|OTHER||Mean Difference (Net)|-36.4|||||TWO_SIDED|95.0|-98.6|25.8|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||25.8|-98.6|
71746724|NCT02831764|143002224|OTHER||Mean Difference (Net)|24.1|||||TWO_SIDED|95.0|-89.0|137.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||137.2|-89.0|
71779703|NCT03345914|143059337|SUPERIORITY||Least Square Mean Difference|-4.11|||<|0.0001|TWO_SIDED|95.0|-5.434|-2.796||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.796|-5.434|< 0.0001
71891206|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.050
71666287|NCT04386616|142846813|OTHER||Difference in Mortality Rates|1.68|||||TWO_SIDED|95.0|-6.89|10.26|||||The difference in mortality rates is calculated as the UTTR1147A Arm minus the Placebo Arm.|||10.26|-6.89|
71666288|NCT04386616|142846813|SUPERIORITY||Odds Ratio (OR)|1.36||||0.4067|TWO_SIDED|95.0|0.66|2.8|||Chi-squared||The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.80|0.66|0.4067
71891207|NCT00190775|143304299|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.840
71666289|NCT04386616|142846813|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6728|TWO_SIDED|95.0|0.56|2.46|||Chi-squared||The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.46|0.56|0.6728
71746725|NCT02831764|143002224|OTHER||Mean Difference (Net)|-26.9|||||TWO_SIDED|95.0|-125.9|72.2|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||72.2|-125.9|
71746726|NCT02831764|143002224|OTHER||Mean Difference (Net)|8.1|||||TWO_SIDED|95.0|-30.3|46.5|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||46.5|-30.3|
71746727|NCT02831764|143002224|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-39.4|46.3|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||46.3|-39.4|
71746728|NCT02831764|143002224|OTHER||Mean Difference (Net)|-121.2|||||TWO_SIDED|95.0|-237.2|-5.1|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||-5.1|-237.2|
71746729|NCT02831764|143002224|OTHER||Mean Difference (Net)|13.1|||||TWO_SIDED|95.0|-106.4|132.6|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||132.6|-106.4|
71746730|NCT02831764|143002224|OTHER||Mean Difference (Net)|114.3|||||TWO_SIDED|95.0|4.6|224.0|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||224.0|4.6|
71746731|NCT02831764|143002225|OTHER||Mean Difference (Net)|-0.0019||||0.759|TWO_SIDED|95.0|-0.0137|0.01|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0100|-0.0137|0.759
71746732|NCT02831764|143002225|OTHER||Mean Difference (Net)|0.0003||||0.943|TWO_SIDED|95.0|-0.0088|0.0095|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0095|-0.0088|0.943
71746733|NCT02831764|143002225|OTHER||Mean Difference (Net)|-0.0019||||0.703|TWO_SIDED|95.0|-0.0117|0.0079|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0079|-0.0117|0.703
71746734|NCT02831764|143002226|OTHER||Mean Difference (Net)|-0.0003||||0.957|TWO_SIDED|95.0|-0.011|0.0104|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0104|-0.0110|0.957
71746735|NCT02831764|143002227|OTHER||Mean Difference (Net)|0.0079||||0.162|TWO_SIDED|95.0|-0.0032|0.0189|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0189|-0.0032|0.162
71746736|NCT02831764|143002228|OTHER||Mean Difference (Net)|-1.3||||0.045|TWO_SIDED|95.0|-2.6|0.0|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0|-2.6|0.045
71746737|NCT02831764|143002228|OTHER||Mean Difference (Net)|-0.6||||0.358|TWO_SIDED|95.0|-1.9|0.7|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-1.9|0.358
71746738|NCT02831764|143002228|OTHER||Mean Difference (Net)|-0.6||||0.328|TWO_SIDED|95.0|-1.9|0.6|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.6|-1.9|0.328
71746739|NCT02831764|143002229|OTHER||Mean Difference (Net)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.7|-2.1|0.318
71746740|NCT02831764|143002230|OTHER||Mean Difference (Net)|0.3||||0.674|TWO_SIDED|95.0|-1.0|1.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||1.6|-1.0|0.674
71746741|NCT04564846|143002231|OTHER||Risk Ratio (RR)|0.974||||0.1628|TWO_SIDED|95.0|0.938|1.011|||Analysis of Covariance||Estimated Difference from Placebo Across All Time Points. Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Comparison to Placebo Across All Time Points||1.011|0.938|0.1628
71746742|NCT04564846|143002233|OTHER||Risk Ratio (RR)|0.784||||0.0674|TWO_SIDED|95.0|0.605|1.017|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|1.017|0.605|0.0674
71891208|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.785
71891209|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.081
71666290|NCT04386616|142846813|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5495|TWO_SIDED|95.0|0.62|2.87|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.87|0.62|0.5495
71746743|NCT04564846|143002234|OTHER|Log transformed values analyzed using an Analysis of Covariance model with treatment and time point as effects and baseline HbA1c as a covariate.|Risk Ratio, log|1.067||||0.8182|TWO_SIDED|95.0|0.976|1.167|||Analysis of Covariance|||Estimated Difference from Placebo Across All Time Points.||1.167|0.976|0.8182
71746744|NCT04564846|143002235|OTHER|AUC Parameters analyzed using an Analysis of Covariance model with treatment as the main effect and baseline HbA1c as a covariate.|Risk Ratio, log|1.007||||0.8182|TWO_SIDED|95.0|0.951|1.066|||Analysis of Covariance|||||1.066|0.951|0.8182
71746745|NCT04564846|143002236|OTHER||Analysis of Variance|0.4628|||||TWO_SIDED|||||Parameter analyzed using an Analysis of Variance model with treatment as the main effect.||||||||
71746746|NCT00387881|143002275|SUPERIORITY_OR_OTHER||Percent difference|18.0|||<|0.001||95.0|10.0|25.0||Endpoints were co-primary and both needed to have p-value of \<0.05 to be considered indicative of efficacy.|Cochran-Mantel-Haenszel||Analysis for Migraine Pain-Free at 2 hours Post-Dose|Pain-Free (2 hours)||25|10|<0.001
71779704|NCT03345914|143059337|SUPERIORITY||Least Square Mean Difference|-3.98|||<|0.0001|TWO_SIDED|95.0|-5.298|-2.657||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.657|-5.298|< 0.0001
71779705|NCT03345914|143059338|SUPERIORITY||Least Square Mean Difference|-3.37|||=|0.0061|TWO_SIDED|95.0|-5.779|-0.962||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.962|-5.779|= 0.0061
71779706|NCT03345914|143059338|SUPERIORITY||Least Square Mean Difference|-3.02|||=|0.0133|TWO_SIDED|95.0|-5.414|-0.629||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.629|-5.414|= 0.0133
71779707|NCT03345914|143059339|SUPERIORITY||Least Square Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.734|-2.272||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-2.272|-6.734|< 0.0001
71834933|NCT04950127|143174428|SUPERIORITY|Fatigue|Mean Difference (Net)|1.59||||0.132|TWO_SIDED|95.0|-0.48|3.67||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||3.67|-0.48|0.132
71834934|NCT04950127|143174428|SUPERIORITY|Itch|Mean Difference (Net)|-0.58||||0.132|TWO_SIDED|95.0|-1.34|0.18||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||0.18|-1.34|0.132
71746747|NCT00387881|143002275|SUPERIORITY_OR_OTHER||Percent difference|15.0|||<|0.001||95.0|8.0|22.0|||Cochran-Mantel-Haenszel||Analysis for Sustained Pain Free from 2-24 hours Post-dose|Sustained Pain-Free (2-24 hours)||22|8|<0.001
71834935|NCT04950127|143174428|SUPERIORITY|Social|Mean Difference (Net)|-0.15||||0.836|TWO_SIDED|95.0|-1.57|1.27||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.27|-1.57|0.836
71746748|NCT03016312|143002286|SUPERIORITY||Hazard Ratio (HR)|1.184||||0.094|TWO_SIDED|95.0|0.971|1.445|||Log Rank|||Unstratified Analysis||1.445|0.971|0.0940
71746749|NCT03016312|143002286|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.2786|TWO_SIDED|95.0|0.913|1.37|||Log Rank|||Stratified Analysis||1.370|0.913|0.2786
71746750|NCT03016312|143002287|SUPERIORITY||Difference in Event Free Rate|-0.2||||0.9391|TWO_SIDED|95.0|-5.38|4.97|||z-test|||Difference in Event Free Rate - 6 months||4.97|-5.38|0.9391
71746751|NCT03016312|143002287|SUPERIORITY||Difference in Event Free Rate|-4.03||||0.2706|TWO_SIDED|95.0|-11.21|3.14|||z-test|||Difference in Event Free Rate - 12 months||3.14|-11.21|0.2706
71746752|NCT03016312|143002289|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.3157|TWO_SIDED|95.0|0.775|1.086|||Log Rank|||Unstratified Analysis||1.086|0.775|0.3157
71746753|NCT03016312|143002289|SUPERIORITY||Hazard Ratio (HR)|0.899||||0.2366|TWO_SIDED|95.0|0.754|1.072|||Log Rank|||Stratified Analysis||1.072|0.754|0.2366
71746754|NCT03016312|143002290|SUPERIORITY||Difference in Event Free Rate|2.21||||0.5959|TWO_SIDED|95.0|-5.95|10.37|||z-test|||Difference in Event Free Rate - 6 months||10.37|-5.95|0.5959
71746755|NCT03016312|143002290|SUPERIORITY||Difference in Event Free Rate|1.44||||0.6262|TWO_SIDED|95.0|-4.35|7.23|||z-test|||Difference in Event Free Rate - 12 months||7.23|-4.35|0.6262
71746756|NCT03016312|143002291|SUPERIORITY||Difference in 50% Decrease Response Rate|1.6|||||TWO_SIDED|2.0|-4.5|7.8|||||||Odds Ratio: 1.1 95%CI: 0.8, 1.5|7.8|-4.5|
71666291|NCT04386616|142846813|SUPERIORITY||Odds Ratio (OR)|1.24||||0.5551|TWO_SIDED|95.0|0.57|2.71|||Cochran-Mantel-Haenszel|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The odds ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.71|0.57|0.5551
71746757|NCT03016312|143002292|SUPERIORITY||Hazard Ratio (HR)|1.055||||0.5359|TWO_SIDED|95.0|0.89|1.251|||Log Rank|||Unstratified Analysis||1.251|0.890|0.5359
71779708|NCT03345914|143059339|SUPERIORITY||Least Square Mean Difference|-5.42|||<|0.0001|TWO_SIDED|95.0|-7.641|-3.207||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata as fixed factors.|ANCOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-3.207|-7.641|< 0.0001
71779709|NCT03345914|143059340|SUPERIORITY||Percentage Differenece|-4.8|||=|0.222|TWO_SIDED|95.0|-12.49|2.87||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||2.87|-12.49|= 0.222
71779710|NCT03345914|143059340|SUPERIORITY||Percentage Differenece|-7.3|||=|0.0508|TWO_SIDED|95.0|-14.51|-0.03||P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by region \[North America vs Europe\] and baseline weight group \[\< 30 kg vs ≥ 30 kg\].|Cochran-Mantel-Haenszel|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level.||-0.03|-14.51|= 0.0508
71746758|NCT03016312|143002292|SUPERIORITY||Hazard Ratio (HR)|1.037||||0.6857|TWO_SIDED|95.0|0.869|1.238|||Log Rank|||Stratified Analysis||1.238|0.869|0.6857
71746759|NCT00496015|143002305|SUPERIORITY|Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%.|Difference in percentages|22.18|||||TWO_SIDED|95.0|11.78|32.11||||||||32.11|11.78|
71746760|NCT00527735|143002338|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806||||0.1302|TWO_SIDED|95.0|0.553|1.174|||1-sided log rank|||||1.174|0.553|0.1302
71746761|NCT00527735|143002338|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.724||||0.0473|TWO_SIDED|95.0|0.495|1.059|||1-sided log rank|||||1.059|0.495|0.0473
71746762|NCT00527735|143002339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.2502|TWO_SIDED|95.0|0.612|1.271|||One-sided log rank|||||1.271|0.612|0.2502
71891210|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.518||95.0||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.518
71746763|NCT00527735|143002339|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.024|TWO_SIDED|95.0|0.478|0.999|||One-sided log rank|||||0.999|0.478|0.0240
71746764|NCT00527735|143002340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988||||0.4759|TWO_SIDED|95.0|0.669|1.46|||1-sided log rank|||||1.460|0.669|0.4759
71746765|NCT00527735|143002340|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.866||||0.234|TWO_SIDED|95.0|0.587|1.278|||1-sided log rank|||||1.278|0.587|0.2340
71746766|NCT00527735|143002347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.1098|TWO_SIDED|95.0|0.475|1.188|||1-sided log rank|||||1.188|0.475|0.1098
71891211|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.883
71891212|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.439
71666292|NCT04386616|142846814|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.3831|TWO_SIDED|95.0|0.71|2.4|||Unstratified Log Rank||The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.40|0.71|0.3831
71666293|NCT04386616|142846814|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5925|TWO_SIDED|95.0|0.65|2.15|||Unstratified Log Rank||The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.15|0.65|0.5925
71746767|NCT00527735|143002347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0282|TWO_SIDED|95.0|0.403|1.1016|||1-sided log rank|||||1.1016|0.403|0.0282
71746768|NCT00527735|143002356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.3846|TWO_SIDED|95.0|0.588|1.481|||1-sided Log Rank|||||1.481|0.588|0.3846
71746769|NCT00527735|143002356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.37|TWO_SIDED|95.0|0.591|1.453|||1-sided Log Rank|||||1.453|0.591|0.3700
71746770|NCT00527735|143002359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.4132|TWO_SIDED|95.0|0.585|1.536|||1-sided Log Rank|||||1.536|0.585|0.4132
71746771|NCT00527735|143002359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.753||||0.1287|TWO_SIDED|95.0|0.461|1.232|||1-sided Log Rank|||||1.232|0.461|0.1287
71746772|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.052||||||6 hour pain at rest|t-test, 2 sided|||||||0.052
71746773|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.064||||||6 hour pain with movement|t-test, 2 sided|||||||0.064
71746774|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.139|||||||t-test, 2 sided|12 hour pain at rest||||||0.139
71746775|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.35||||||12 hour pain at rest|t-test, 2 sided|||||||0.350
71746776|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.021||||||18 hour pain at rest|t-test, 2 sided|||||||0.021
71746777|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.198||||||18 hour pain with movement|t-test, 2 sided|||||||0.198
71746778|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.806|||||||t-test, 2 sided|24 hour pain at rest||||||0.806
71746779|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.228||||||24 hour pain with movement|t-test, 2 sided|||||||0.228
71746780|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.457||||||36 hour pain at rest|t-test, 2 sided|||||||0.457
71746781|NCT02271698|143002386|SUPERIORITY_OR_OTHER|||||||0.394||||||36 hour pain with movement|t-test, 2 sided|||||||0.394
71834936|NCT04950127|143174428|SUPERIORITY|Symptoms|Mean Difference (Net)|0.45||||0.318|TWO_SIDED|95.0|-0.44|1.34||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PBC-40 domain scores, Visit\*Baseline PBC-40 domain scores interaction, Baseline Concomitant Itch Medication.||1.34|-0.44|0.318
71834937|NCT04950127|143174429|SUPERIORITY||Mean Difference (Net)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.55|-0.2||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline PGI-S score, Visit\*Baseline PGI-S score interaction, Baseline Concomitant Itch Medication.||-0.20|-0.55|<0.001
71834938|NCT04950127|143174430|SUPERIORITY||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.76|-0.21||Not adjusted for multiplicity; two-sided p- values \<0.05 were considered to be nominally significant as per SAP.|Mixed Models Analysis|Mixed Model Repeated Measures Analysis||The mixed model repeated measures analysis includes Treatment Group, Visit, Visit\*Treatment Group interaction, Baseline Concomitant Itch Medication.||-0.21|-0.76|<0.001
71891213|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.167
71891214|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.381
71891215|NCT00190775|143304300|SUPERIORITY_OR_OTHER|||||||0.906||95.0||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.906
71891216|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.420
71891217|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.249
71891218|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.927||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.927
71666294|NCT04386616|142846814|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7487|TWO_SIDED|95.0|0.6|2.05|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the MSTT1041A Arm relative to the Placebo Arm.|||2.05|0.60|0.7487
71891219|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.205
71891220|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.673||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.673
71891221|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.881||95.0||||P-Value for Parent Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.881
71891222|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.808
71834939|NCT03833167|143174434|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.07243|TWO_SIDED|95.0|0.53|1.1||One-sided p-value based on log-rank test stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||1.10|0.53|0.07243
71891223|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.498
71666295|NCT04386616|142846814|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.6092|TWO_SIDED|95.0|0.63|2.21|||Stratified Log Rank|The analysis was adjusted for the baseline characteristics of region of enrollment and need for mechanical ventilation.|The hazard ratio was calculated as the UTTR1147A Arm relative to the Placebo Arm.|||2.21|0.63|0.6092
71666296|NCT00993421|142846837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71891224|NCT00190775|143304301|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.283
71891225|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.784
71891226|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.864
71666297|NCT00993421|142846837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71891227|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.884
71891228|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.072
71891229|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.120
71891230|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.925||95.0||||P-Value Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.925
71891231|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.444||95.0||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.444
71666298|NCT00993421|142846837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71666299|NCT00993421|142846837|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||<0.001
71666300|NCT00993421|142846837|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.041
71666301|NCT00993421|142846837|SUPERIORITY_OR_OTHER|||||||0.668||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.668
71666302|NCT00993421|142846837|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.437
71666303|NCT00993421|142846837|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.||||0.249
71779711|NCT03345914|143059343|SUPERIORITY||Least Square Mean Difference|-5.7|||=|0.003|TWO_SIDED|95.0|-9.49|-1.96||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level||-1.96|-9.49|= 0.003
71779712|NCT03345914|143059343|SUPERIORITY|A 2-sided hierarchical testing procedure was used for the primary and secondary endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level|Least Square Mean Difference|-5.1|||=|0.0082|TWO_SIDED|95.0|-8.8|-1.31||The confidence interval (CI) with p-value was based on treatment difference (Dupilumab group vs placebo) of the LS mean percent change using ANOVA model with the treatment, randomization strata as fixed factors.|ANOVA|||||-1.31|-8.8|= 0.0082
71746782|NCT02271698|143002387|SUPERIORITY_OR_OTHER|||||||0.181||||||6 hours|t-test, 2 sided|||||||0.181
71746783|NCT02271698|143002387|SUPERIORITY_OR_OTHER|||||||0.364||||||12 hours|t-test, 2 sided|||||||0.364
71834940|NCT03833167|143174435|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|95.0|0.87|2.48|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by baseline Extracapsular extension (yes versus no) and Cortical bone invasion (yes versus no) with small strata collapsed.|||2.48|0.87|
71666304|NCT00352417|142846870|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|Satterthwaite's method||||||0.97
71666305|NCT00352417|142846871|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|Satterthwaite's method||||||0.37
71666306|NCT00352417|142846872|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71746784|NCT02271698|143002387|SUPERIORITY_OR_OTHER|||||||0.605|||||||t-test, 2 sided|18 hours||||||0.605
71746785|NCT02271698|143002387|SUPERIORITY_OR_OTHER|||||||0.733|||||||t-test, 2 sided|24 hours||||||0.733
71834941|NCT03833167|143174436|SUPERIORITY||Mean Difference (Final Values)|-3.41||||0.2227|TWO_SIDED|95.0|-8.91|2.09||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||2.09|-8.91|0.2227
71666307|NCT00352417|142846873|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|ANCOVA was performed on the natural log transformed data||||||<0.01
71666308|NCT00352417|142846874|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71666309|NCT02555254|142846887|SUPERIORITY|||||||0.55|||||||Wilcoxon's rank test|||||||0.55
71666310|NCT04140032|142846891|SUPERIORITY||Difference between groups in change in B|-0.18|STANDARD_DEVIATION|0.06||0.003|TWO_SIDED|95.0|-0.31|-0.06|||Mixed Models Analysis|p \< 0.05 considered significant||||-0.06|-0.31|0.003
71666311|NCT04140032|142846892|SUPERIORITY||Odds ratio for difference between groups|1.29||||0.7|TWO_SIDED|95.0|0.034|4.91|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||4.91|.034|0.7
71666312|NCT04140032|142846893|SUPERIORITY||Difference between groups in change in f|-0.2|STANDARD_DEVIATION|0.19||0.3|TWO_SIDED|95.0|-0.58|0.17|||Mixed Models Analysis|||||0.17|-0.58|0.3
71666313|NCT04140032|142846897|SUPERIORITY||Odds ratio for difference between groups|1.1|STANDARD_ERROR_OF_MEAN|0.35||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
71746786|NCT02271698|143002387|SUPERIORITY_OR_OTHER|||||||0.6||||||36 hours|t-test, 2 sided|||||||0.600
71746787|NCT03985761|143002403|SUPERIORITY|||||||0.182|||||||ANOVA|||||||.182
71746788|NCT03985761|143002404|SUPERIORITY|||||||0.296|||||||ANOVA|||||||.296
71746789|NCT03985761|143002405|SUPERIORITY|||||||0.483|||||||ANOVA|||||||.483
71746790|NCT03985761|143002406|SUPERIORITY|||||||0.995|||||||ANOVA|||||||.995
71746791|NCT03985761|143002407|SUPERIORITY|||||||0.22|||||||ANOVA|||||||.220
71746792|NCT03985761|143002408|SUPERIORITY|||||||0.538|||||||ANOVA|||||||.538
71746793|NCT03985761|143002411|SUPERIORITY|||||||0.121|||||||ANOVA|||||||.121
71746794|NCT01755234|143002413|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
71746795|NCT01755234|143002414|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.96
71746796|NCT01755234|143002415|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.96
71746797|NCT01755234|143002416|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.84
71666314|NCT04140032|142846897|SUPERIORITY||Odds ratio for difference between groups|1.1||||0.8|TWO_SIDED|95.0|0.56|2.16|||Mixed Models Analysis|p \< 0.05 considered significant|Reported dispersion parameter is standard error of log(OR)|||2.16|0.56|0.8
71666315|NCT06075277|142846902|OTHER||Ratios of adjusted geometric means [%]|126.64|||||TWO_SIDED|90.0|112.09|143.08|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.8|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||143.08|112.09|
71666316|NCT06075277|142846903|OTHER||Ratios of adjusted geometric means [%]|126.12|||||TWO_SIDED|90.0|106.34|149.58|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 27.9.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||149.58|106.34|
71666317|NCT06075277|142846904|OTHER||Ratios of adjusted geometric means [%]|126.04|||||TWO_SIDED|90.0|111.7|142.21|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 19.6.|Relative bioavailability of Zongertinib administered in fed state (Test) compared with Zongertinib administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% confidence intervals (CIs) were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||142.21|111.70|
71666318|NCT03975491|142846907|SUPERIORITY||Mean Difference (Net)|20.9||||0.32|TWO_SIDED|95.0|-17.1|76.2|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||76.2|-17.1|0.32
71746798|NCT05757648|143002426|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.005
71779713|NCT01952145|143059350|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDegLira versus IGlar was considered as confirmed, if the 95% confidence interval (CI) for the mean treatment difference was entirely below 0.30%.|Treatment contrast|-0.59|||<|0.001|TWO_SIDED|95.0|-0.74|-0.45|||ANCOVA|||This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.||-0.45|-0.74|< 0.001
71779714|NCT03758066|143059357|OTHER|||||||0.03||||||P-value reported for quality of life measured between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.03
71779715|NCT03758066|143059358|SUPERIORITY|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between baseline and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||A two-tailed non-parametric one-sample paired sign test was used to determine whether to reject or fail to reject the null hypothesis that the mean difference of scores between any of the 2 of 3 timepoints is 0 (Baseline v. 6-month, 6-month v. 12-month, and Baseline v. 12-month).||||.02
71834942|NCT03833167|143174437|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.1874|TWO_SIDED|95.0|-7.19|1.42||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|Log Rank||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Extracapsular extension, Cortical bone invasion, and Prior systemic therapy.|||1.42|-7.19|0.1874
71834943|NCT05064735|143174495|SUPERIORITY||Estimated Treatment Difference|-10.48|||<|0.0001|TWO_SIDED|95.0|-12.34|-8.63|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline body weight as covariate.||-8.63|-12.34|<0.0001
71666319|NCT03975491|142846908|SUPERIORITY||Mean Difference (Net)|11.4||||0.25|TWO_SIDED|95.0|-7.5|34.0|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||34.0|-7.5|0.25
71666320|NCT03975491|142846909|SUPERIORITY||Mean Difference (Net)|-3.6||||0.52|TWO_SIDED|95.0|-13.7|7.7|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||7.7|-13.7|0.52
71746799|NCT05757648|143002427|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
71779716|NCT03758066|143059358|OTHER|||||||0.02||||||P-value reported for self-reported self-efficacy in chronic disease management between 6- and 12-month follow-up with a statistical significance threshold of .05.|Sign test|||||||.02
71779717|NCT04138810|143059361|NON_INFERIORITY|We defined the non-inferiority margin to be 5 points which with a sample of size of 25 women per arm would mean we would have a type I error rate of 0.05 and a power of 0.80.|Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-1.95|1.03||||||||1.03|-1.95|
71779718|NCT01786668|143059362|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.8|||||TWO_SIDED|95.0|5.0|30.3|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||30.3|5.0|
71779719|NCT01786668|143059362|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.9|||||TWO_SIDED|95.0|8.4|37.7|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||37.7|8.4|
71834944|NCT05064735|143174496|SUPERIORITY||Estimated Treatment Difference|-14.14|||<|0.0001|TWO_SIDED|95.0|-19.98|-8.3|||ANCOVA|||The responses at week 68 were analyzed using an analysis of covariance model with randomized treatment as factor and baseline WOMAC pain score as covariate.||-8.30|-19.98|<0.0001
71746800|NCT05757648|143002428|SUPERIORITY|||||||0.682|||||||Mixed Models Analysis|||||||0.682
71746801|NCT00101686|143002447|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.433||||0.0152||95.0|1.09|1.89||p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.|Log Rank||Hazard ratio \[mIRI:FOLFIRI\] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (\<=70 vs \>70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.|||1.89|1.09|0.0152
71779720|NCT01786668|143059362|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.3|||||TWO_SIDED|95.0|10.7|43.4|||Emax Model|||Emax model - 95% Confidence Interval represents 95% Credible Interval||43.4|10.7|
71666321|NCT03975491|142846910|SUPERIORITY||Mean Difference (Net)|0.59||||0.21|TWO_SIDED|95.0|-0.33|1.51|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||1.51|-0.33|0.21
71666322|NCT03975491|142846912|SUPERIORITY||Mean Difference (Net)|0.0005||||0.73|TWO_SIDED|95.0|-0.0024|0.0034|||Mixed Models Analysis||From a model that included the baseline value of the dependent variable and sex (randomization stratification factor) as covariates.|||0.0034|-0.0024|0.73
71666323|NCT04034927|142846935|SUPERIORITY||Odds Ratio (OR)|0.707|||||TWO_SIDED|95.0|0.241|2.068|||||The numerator is the experimental arm (odds of response) and the denominator is the control arm (odds of response).|Odds ratio for experimental arm (O + T) response compared to control arm (O) response.||2.068|0.241|
71666324|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|1.82|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|1.76|1.88||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.||1.88|1.76|<.0001
71746802|NCT00101686|143002448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.512||||0.0042||95.0|1.16|1.97|||Log Rank|||||1.97|1.16|0.0042
71746803|NCT00101686|143002448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.368||||0.0156||95.0|1.04|1.8|||Log Rank|||||1.80|1.04|0.0156
71746804|NCT00101686|143002448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.4659||95.0|0.81|1.38|||Log Rank|||||1.38|0.81|0.4659
71779721|NCT01786668|143059363|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.75|STANDARD_ERROR_OF_MEAN|9.77||0.271|TWO_SIDED|95.0|-8.41|29.9|||Normal approximation for two proportions|||||29.90|-8.41|0.271
71779722|NCT01786668|143059363|SUPERIORITY_OR_OTHER||Risk Difference (RD)|39.59|STANDARD_ERROR_OF_MEAN|8.8|<|0.001|TWO_SIDED|95.0|22.35|56.83|||Normal approximation for two proportions|||||56.83|22.35|<0.001
71891232|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.166
71666325|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.81|2.0||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.00|1.81|<.0001
71746805|NCT00101686|143002449|SUPERIORITY_OR_OTHER||F-distribution method|47.2||||||95.0|38.85|55.71|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||55.71|38.85|
71779723|NCT01786668|143059363|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.59|STANDARD_ERROR_OF_MEAN|9.74||0.134|TWO_SIDED|95.0|-4.5|33.69|||Normal approximation for two proportions|||||33.69|-4.50|0.134
71779724|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 2||31.04|-5.17|0.162
71746806|NCT00101686|143002449|SUPERIORITY_OR_OTHER||F-distribution method|43.3||||||95.0|34.95|51.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||51.86|34.95|
71746807|NCT00101686|143002449|SUPERIORITY_OR_OTHER||F-distribution method|38.6||||||95.0|30.66|47.06|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||47.06|30.66|
71746808|NCT00101686|143002449|SUPERIORITY_OR_OTHER|||||||0.4751|||||||Cochran-Mantel-Haenszel|||||||0.4751
71746809|NCT00101686|143002449|SUPERIORITY_OR_OTHER|||||||0.1591|||||||Cochran-Mantel-Haenszel|||||||0.1591
71746810|NCT00101686|143002449|SUPERIORITY_OR_OTHER|||||||0.4395|||||||Cochran-Mantel-Haenszel|||||||0.4395
71746811|NCT00101686|143002450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.268||||0.0879||95.0|0.96|1.68|||Log Rank|||||1.68|0.96|0.0879
71746812|NCT00101686|143002450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.2765||95.0|0.9|1.58|||Log Rank|||||1.58|0.90|0.2765
71746813|NCT00101686|143002450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.049||||0.9364||95.0|0.8|1.38|||Log Rank|||||1.38|0.80|0.9364
71746814|NCT00101686|143002452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.068||||0.7163||95.0|0.86|1.33|||Log Rank|||||1.33|0.86|0.7163
71746815|NCT00101686|143002453|SUPERIORITY_OR_OTHER||F-distribution method|39.4||||||95.0|32.83|46.34|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||46.34|32.83|
71746816|NCT00101686|143002453|SUPERIORITY_OR_OTHER||F-distribution method|46.5||||||95.0|39.76|53.42|||||confidence interval for binomial proportion using the F-distribution method (unit: %)|||53.42|39.76|
71746817|NCT00101686|143002453|SUPERIORITY_OR_OTHER|||||||0.1559|||||||Cochran-Mantel-Haenszel|||||||0.1559
71746818|NCT00101686|143002454|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5316||95.0|0.86|1.36|||Log Rank|||||1.36|0.86|0.5316
71746819|NCT00101686|143002455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.269||||0.2835||95.0|0.75|2.15|||Log Rank|||||2.15|0.75|0.2835
71779725|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 2||22.92|-12.44|0.561
71779726|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 2||24.97|-10.65|0.430
71779727|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
71891233|NCT00190775|143304302|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
71666326|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.29|1.44||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.44|1.29|<.0001
71666327|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.2|2.33||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.33|2.20|<.0001
71666328|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|1.69|1.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||1.85|1.69|<.0001
71666329|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.85|2.06||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Internal morphology; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.06|1.85|<.0001
71666330|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|2.77|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|2.69|2.85||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.85|2.69|<.0001
71666331|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|2.49|2.67||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement - Reader 2. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.67|2.49|<.0001
71746820|NCT00101686|143002456|SUPERIORITY_OR_OTHER||F-distribution method|57.9||||||95.0|44.08|70.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||70.86|44.08|
71746821|NCT00101686|143002456|SUPERIORITY_OR_OTHER||F-distribution method|53.3||||||95.0|40.0|66.33|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)|||66.33|40.00|
71746822|NCT00101686|143002456|SUPERIORITY_OR_OTHER|||||||0.7388|||||||Cochran-Mantel-Haenszel|||||||0.7388
71779728|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.44|STANDARD_ERROR_OF_MEAN|9.54||0.019|TWO_SIDED|95.0|3.74|41.13|||Normal approximation for two proportions|||Week 4||41.13|3.74|0.019
71779729|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.74|STANDARD_ERROR_OF_MEAN|9.57||0.123|TWO_SIDED|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4||33.50|-4.01|0.123
71845275|NCT05886777|143204388|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A, RSV B as measured by NT:H0: ln(μ2)- ln(μ4) \<=ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 2, 4, respectively.|Geometric mean ratio|1.09|||||TWO_SIDED|97.5|0.836|1.429|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.429|0.836|
71746823|NCT00101686|143002458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.794||||0.037||95.0|1.12|2.88|||Log Rank|||||2.88|1.12|0.0370
71746824|NCT02920892|143002462|SUPERIORITY||Slope|-0.1||||0.1587|TWO_SIDED|90.0|-0.22|0.02|||Mixed Models Analysis|||||0.02|-0.22|0.1587
71779730|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.56|STANDARD_ERROR_OF_MEAN|9.75||0.135|TWO_SIDED|95.0|-4.55|33.66|||Normal approximation for two proportions|||Week 8||33.66|-4.55|0.135
71891234|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.895||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.895
71666332|NCT03996447|142846952|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|2.84|2.95||To demonstrate the superiority, a statistically significant (one-sided p-value ≤0.025) positive difference in mean scores in border delineation, internal morphology and degree of contrast enhancement of lesions had to be met for 2 out of 3 readers.|t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3. The null hypothesis was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error at 0.025. To conclude the superiority of gadopiclenol-enhanced MRI, the null hypothesis had to be rejected for all co-criteria simultaneously.||2.95|2.84|<.0001
71666333|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.06|0.02||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.02|-0.06|<0.0001
71666334|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority between gadopiclenol and gadobutrol was concluded if the lower bound of this confidence interval was above the non-inferiority margin set to 0.35 for at least 2 out of 3 blinded readers and for the 3 co-primary criteria simultaneously.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.04|0.11||The Null hypothesis was rejected if the 2-sided 95% Confidence Interval (CI) for the difference \[gadopiclenol scores mean - gadobutrol scores mean\] had its lower limit above -0.35.|t-test, 2 sided|The Student's t-based 95% CIs of the difference between gadopiclenol and gadobutrol were constructed for each of 3 co-primary criteria.||Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.||0.11|-0.04|<0.0001
71666335|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.01|0.05|||t-test, 2 sided|||Criterion: Border delineation; Reader 3||0.05|-0.01|<0.0001
71666336|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.04|0.03|||t-test, 2 sided|||Criterion: Internal morphology; Reader 1||0.03|-0.04|<0.0001
71666337|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.05|0.09|||t-test, 2 sided|||Criterion: Internal morphology; Reader 2||0.09|-0.05|<0.0001
71746825|NCT02920892|143002463|SUPERIORITY||Slope|-1.66||||0.1054|TWO_SIDED|90.0|-3.34|0.03|||Mixed Models Analysis|||||0.03|-3.34|0.1054
71666338|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.01|0.08|||t-test, 2 sided|||Criterion: Internal morphology; Reader 3||0.08|0.01|<0.0001
71666339|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.0001|TWO_SIDED|95.0|-0.04|0.07|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 1||0.07|-0.04|0.0001
71746826|NCT02920892|143002464|SUPERIORITY||Slope|-0.67||||0.32|TWO_SIDED|90.0|-1.79|0.45|||Mixed Models Analysis|||||0.45|-1.79|0.32
71746827|NCT02920892|143002465|SUPERIORITY||Slope|-0.29||||0.78|TWO_SIDED|90.0|-1.98|1.4|||Mixed Models Analysis|||||1.4|-1.98|0.78
71779731|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.02|STANDARD_ERROR_OF_MEAN|9.36||0.003|TWO_SIDED|95.0|9.68|46.36|||Normal approximation for two proportions|||Week 8||46.36|9.68|0.003
71779732|NCT01786668|143059364|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.71|STANDARD_ERROR_OF_MEAN|9.79||0.274|TWO_SIDED|95.0|-8.48|29.9|||Normal approximation for two proportions|||Week 8||29.90|-8.48|0.274
71891235|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.792
71746828|NCT02920892|143002466|SUPERIORITY||Slope|0.1||||0.94|TWO_SIDED|90.0|-2.05|2.24|||Mixed Models Analysis|||||2.24|-2.05|0.94
71746829|NCT02920892|143002467|SUPERIORITY||Slope|-0.85||||0.1428|TWO_SIDED|90.0|-1.81|0.11|||Mixed Models Analysis|||||0.11|-1.81|0.1428
71746830|NCT02920892|143002468|SUPERIORITY||Odds Ratio (OR)|0.9462||||0.24|TWO_SIDED|90.0|0.8764|1.0215|||Mixed Models Analysis|||||1.0215|0.8764|0.24
71779733|NCT01786668|143059365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.123||0.427|TWO_SIDED|95.0|-3.11|1.32|||ANCOVA|||||1.32|-3.11|0.427
71779734|NCT01786668|143059365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|1.13||0.039|TWO_SIDED|95.0|-4.58|-0.12|||ANCOVA|||||-0.12|-4.58|0.039
71779735|NCT01786668|143059365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|STANDARD_ERROR_OF_MEAN|1.131||0.016|TWO_SIDED|95.0|-4.97|-0.51|||ANCOVA|||||-0.51|-4.97|0.016
71779736|NCT01786668|143059366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.517||0.05|TWO_SIDED|95.0|-5.99|0.0|||ANCOVA|||||-0.00|-5.99|0.050
71779737|NCT01786668|143059366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.42|-2.42|||ANCOVA|||||-2.42|-8.42|<0.001
71891236|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.318
71666340|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.03|0.12|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 2||0.12|-0.03|<0.0001
71666341|NCT03996447|142846953|NON_INFERIORITY|Non-inferiority margin : -0.35|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.03|0.15|||t-test, 2 sided|||Criterion: Contrast enhancement; Reader 3||0.15|0.03|<0.0001
71666342|NCT03355469|142846954|SUPERIORITY||Mean Difference (Final Values)|3.53||||0.045|TWO_SIDED|95.0|0.08|6.99||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|Linear ANCOVA model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.99|0.08|0.045
71666343|NCT03355469|142846954|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.507|TWO_SIDED|95.0|-2.42|4.73||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||4.73|-2.42|0.507
71746831|NCT02920892|143002469|SUPERIORITY||Odds Ratio (OR)|0.95||||0.92|TWO_SIDED|90.0|0.4|2.27|||Mixed Models Analysis|||||2.27|0.4|0.92
71746832|NCT03649217|143002484|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
71746833|NCT03649217|143002485|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||.0001
71746834|NCT03649217|143002486|SUPERIORITY|||||||0.001|||||||ANOVA|||||||.001
71779738|NCT01786668|143059366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|1.525|<|0.001|TWO_SIDED|95.0|-9.48|-3.46|||ANCOVA|||||-3.46|-9.48|<0.001
71779739|NCT01786668|143059367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.52||0.221|TWO_SIDED|95.0|-1.66|0.39|||ANCOVA|||||0.39|-1.66|0.221
71891237|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.914
71891238|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.961||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.961
71746835|NCT03649217|143002487|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||.0002
71746836|NCT03649217|143002488|SUPERIORITY|||||||0.006|||||||ANOVA|||||||.006
71746837|NCT00721396|143002495|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence interval of the difference in the percentage of subjects with hSBA titer ≥1:5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 44/76-SL strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
71746838|NCT00721396|143002495|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference %(B+R246 minus B246_R357)|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against 5/99 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||1|-1|
71746839|NCT00721396|143002495|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R246 was considered non-inferior to response of Group B246\_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|-8.0|||||TWO_SIDED|95.0|-12.0|-4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against NZ98/254 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.||-4|-12|
71746840|NCT00721396|143002496|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for diphtheria (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Diphtheria antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-1|
71779740|NCT01786668|143059367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.83|-0.78|||ANCOVA|||||-0.78|-2.83|<0.001
71779741|NCT01786668|143059367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.523||0.001|TWO_SIDED|95.0|-2.75|-0.68|||ANCOVA|||||-0.68|-2.75|0.001
71779742|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
71779743|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
71779744|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.62|STANDARD_ERROR_OF_MEAN|7.31||0.824|TWO_SIDED|95.0|-12.71|15.95|||Normal approximation for two proportions|||Week 2||15.95|-12.71|0.824
71779745|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.16|STANDARD_ERROR_OF_MEAN|8.09||0.104|TWO_SIDED|95.0|-2.69|29.01|||Normal approximation for two proportions|||Week 4||29.01|-2.69|0.104
71779746|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.01|STANDARD_ERROR_OF_MEAN|8.26||0.04|TWO_SIDED|95.0|0.81|33.2|||Normal approximation for two proportions|||Week 4||33.20|0.81|0.040
71666344|NCT03355469|142846954|SUPERIORITY||Mean Difference (Final Values)|4.98||||0.014|TWO_SIDED|95.0|1.14|8.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.83|1.14|0.014
71746841|NCT00721396|143002496|NON_INFERIORITY_OR_EQUIVALENCE|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for tetanus toxoid (≥0.1 IU/mL) was \>-10%.|Difference %(B+R234 minus R234)|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Non-inferiority of immune response to Tetanus antigens when routine vaccines are administered concomitantly with rMen+OMV NZ vaccine.||2|-1|
71746842|NCT00721396|143002501|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-5.0|4.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen FHA when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||4|-5|
71746843|NCT00721396|143002501|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen pertactin antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-7|
71746844|NCT00721396|143002501|NON_INFERIORITY_OR_EQUIVALENCE|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen method|||Non-inferiority of immune responses against Pertussis antigen PT when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.||2|-4|
71746845|NCT02021565|143002515|SUPERIORITY|||||||0.973||||||alpha = 0.025|ANOVA|Repeated measures||Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.||||0.973
71746846|NCT02021565|143002515|SUPERIORITY|Alpha = .025||||||0.223|||||||ANOVA|||Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.||||0.223
71779747|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 4||20.40|-9.46|0.473
71891239|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.807
71891240|NCT00190775|143304303|SUPERIORITY_OR_OTHER|||||||0.827||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.827
71746847|NCT02021565|143002516|SUPERIORITY|||||||0.547|||||||ANOVA|||Analysis 1 is for the Veteran care recipient reported task efficacy||||0.547
71746848|NCT02021565|143002516|SUPERIORITY|||||||0.891|||||||ANOVA|||Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.||||0.891
71746849|NCT02021565|143002517|SUPERIORITY|||||||0.729|||||||ANOVA|||||||0.729
71746850|NCT03318549|143002518|OTHER|||||||0.011|||||||t-test, 2 sided|||||||0.011
71746851|NCT03318549|143002518|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
71746852|NCT03318549|143002519|OTHER|||||||0.303|||||||Chi-squared|||||||0.303
71746853|NCT03318549|143002522|OTHER|||||||0.132|||||||t-test, 2 sided|||||||0.132
71746854|NCT03318549|143002522|OTHER|||||||0.647|||||||t-test, 2 sided|||||||0.647
71746855|NCT00607087|143002538|SUPERIORITY_OR_OTHER|||||||0.039||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.039
71746856|NCT00607087|143002538|SUPERIORITY_OR_OTHER|||||||0.031||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025.|McNemar|||||||0.031
71746857|NCT00607087|143002539|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71746858|NCT00607087|143002539|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71779748|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.4|STANDARD_ERROR_OF_MEAN|8.86||0.875|TWO_SIDED|95.0|-15.97|18.76|||Normal approximation for two proportions|||Week 8||18.76|-15.97|0.875
71779749|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
71779750|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.09|STANDARD_ERROR_OF_MEAN|9.15||0.32|TWO_SIDED|95.0|-8.84|27.01|||Normal approximation for two proportions|||Week 8||27.01|-8.84|0.320
71891241|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.828
71891242|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.401
71746859|NCT00607087|143002540|SUPERIORITY_OR_OTHER|||||||0.08||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.080
71834945|NCT02376790|143174529|SUPERIORITY||Treatment Difference|13.9||||0.005|TWO_SIDED|95.0|5.8|22.0||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||22.0|5.8|0.005
71834946|NCT02376790|143174529|SUPERIORITY||Treatment Difference|9.2||||0.029|TWO_SIDED|95.0|1.0|17.3||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.||17.3|1.0|0.029
71834947|NCT02376790|143174530|SUPERIORITY||Treatment Difference|12.2||||0.005|TWO_SIDED|95.0|4.9|19.6||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||19.6|4.9|0.005
71845276|NCT05886777|143204389|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.594|1.19|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.190|0.594|
71891243|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.300
71891244|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.575
71891245|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.772||95.0||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.772
71746860|NCT00607087|143002540|SUPERIORITY_OR_OTHER|||||||0.107||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.107
71746861|NCT00607087|143002541|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71746862|NCT00607087|143002541|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||<0.001
71746863|NCT00607087|143002542|SUPERIORITY_OR_OTHER|||||||0.079||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.079
71746864|NCT00607087|143002542|SUPERIORITY_OR_OTHER|||||||0.063||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.063
71746865|NCT00607087|143002543|SUPERIORITY_OR_OTHER|||||||0.015||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.015
71746866|NCT00607087|143002543|SUPERIORITY_OR_OTHER|||||||0.073||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.073
71746867|NCT00607087|143002544|SUPERIORITY_OR_OTHER|||||||0.017||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.017
71746868|NCT00607087|143002544|SUPERIORITY_OR_OTHER|||||||0.032||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.032
71746869|NCT00607087|143002545|SUPERIORITY_OR_OTHER|||||||0.009||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.009
71746870|NCT00607087|143002545|SUPERIORITY_OR_OTHER|||||||0.019||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.019
71779751|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 12||39.99|5.41|0.010
71779752|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.55|STANDARD_ERROR_OF_MEAN|8.87||0.003|TWO_SIDED|95.0|9.16|43.93|||Normal approximation for two proportions|||Week 12||43.93|9.16|0.003
71779753|NCT01786668|143059368|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.85|STANDARD_ERROR_OF_MEAN|8.74||0.031|TWO_SIDED|95.0|1.72|35.99|||Normal approximation for two proportions|||Week 12||35.99|1.72|0.031
71779754|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.23|STANDARD_ERROR_OF_MEAN|6.95||0.028|TWO_SIDED|95.0|1.61|28.86|||Normal approximation for two proportions|||Week 2||28.86|1.61|0.028
71779755|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 2||17.47|-6.23|0.353
71891246|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.918||95.0||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.918
71891247|NCT00190775|143304304|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.636
71746871|NCT00607087|143002546|SUPERIORITY_OR_OTHER|||||||0.008||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.008
71746872|NCT00607087|143002546|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71746873|NCT00607087|143002547|SUPERIORITY_OR_OTHER|||||||0.563||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.563
71779756|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.31|STANDARD_ERROR_OF_MEAN|6.8||0.05|TWO_SIDED|95.0|-0.02|26.64|||Normal approximation for two proportions|||Week 2||26.64|-0.02|0.050
71779757|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.39|STANDARD_ERROR_OF_MEAN|6.64||0.086|TWO_SIDED|95.0|-1.62|24.39|||Normal approximation for two proportions|||Week 4||24.39|-1.62|0.086
71891248|NCT00190775|143304305|SUPERIORITY_OR_OTHER|||||||0.583||95.0||||P-Value for Total ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.583
71891249|NCT00190775|143304305|SUPERIORITY_OR_OTHER|||||||0.997||95.0||||P-Value for Hyperactive-Impulsive Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.997
71746874|NCT00607087|143002547|SUPERIORITY_OR_OTHER|||||||0.186||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||0.186
71779758|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.93|STANDARD_ERROR_OF_MEAN|7.43||0.002|TWO_SIDED|95.0|8.37|37.48|||Normal approximation for two proportions|||Week 4||37.48|8.37|0.002
71779759|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|STANDARD_ERROR_OF_MEAN|7.32||0.004|TWO_SIDED|95.0|6.65|35.36|||Normal approximation for two proportions|||Week 4||35.36|6.65|0.004
71779760|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.35|STANDARD_ERROR_OF_MEAN|7.03||0.106|TWO_SIDED|95.0|-2.43|25.13|||Normal approximation for two proportions|||Week 8||25.13|-2.43|0.106
71779761|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.5|STANDARD_ERROR_OF_MEAN|8.02|<|0.001|TWO_SIDED|95.0|16.79|48.22|||Normal approximation for two proportions|||Week 8||48.22|16.79|<0.001
71779762|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.04|STANDARD_ERROR_OF_MEAN|7.54||0.012|TWO_SIDED|95.0|4.27|33.81|||Normal approximation for two proportions|||Week 8||33.81|4.27|0.012
71779763|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.54|STANDARD_ERROR_OF_MEAN|7.47||0.635|TWO_SIDED|95.0|-11.1|18.19|||Normal approximation for two proportions|||Week 12||18.19|-11.10|0.635
71779764|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|34.31|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|17.45|51.18|||Normal approximation for two proportions|||Week 12||51.18|17.45|<0.001
71779765|NCT01786668|143059369|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.78|STANDARD_ERROR_OF_MEAN|8.45||0.007|TWO_SIDED|95.0|6.21|39.34|||Normal approximation for two proportions|||Week 12||39.34|6.21|0.007
71779766|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.136||0.175|TWO_SIDED|95.0|-0.46|0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.08|-0.46|0.175
71891250|NCT00190775|143304305|SUPERIORITY_OR_OTHER|||||||0.333||95.0||||P-Value for Inattention Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.333
71891251|NCT00190775|143304306|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-Value for Oppositional Defiant Disorder Flag|Fisher Exact|||||||.792
71891252|NCT00190775|143304306|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-Value for Conduct Disorder Flag.|Fisher Exact|||||||0.675
71891253|NCT00190775|143304307|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.875
71746875|NCT00607087|143002548|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71746876|NCT00607087|143002548|SUPERIORITY_OR_OTHER||||||<|0.001||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|Mixed Models Analysis|||||||<0.001
71746877|NCT00607087|143002549|SUPERIORITY_OR_OTHER|||||||1||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||1.000
71746878|NCT00607087|143002549|SUPERIORITY_OR_OTHER|||||||0.701||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|McNemar|||||||0.701
71746879|NCT00607087|143002552|SUPERIORITY_OR_OTHER|||||||0.078||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c value at the start of the first period||||||0.078
71746880|NCT00607087|143002552|SUPERIORITY_OR_OTHER|||||||0.938||97.5||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is \<0.025|ANCOVA|ANCOVA adjusted on HbA1c level at the start of the first period||||||0.938
71779767|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.77|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.24|-0.77|<0.001
71779768|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.74|-0.2|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||-0.20|-0.74|<0.001
71779769|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|-0.7|-0.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.15|-0.70|0.003
71779770|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.9|-0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.34|-0.90|<0.001
71891254|NCT00190775|143304307|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.569
71746881|NCT01774799|143002681|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.69|1.69||||||||1.69|0.69|
71746882|NCT01774799|143002682|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.66|2.2||||||||2.20|0.66|
71746883|NCT01774799|143002683|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.58|1.58||||||||1.58|0.58|
71746884|NCT01774799|143002684|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.13|2.82||||||||2.82|1.13|
71746885|NCT01774799|143002685|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
71746886|NCT02586623|143002686|SUPERIORITY||Cox Proportional Hazard|1.04||||0.803|TWO_SIDED|95.0|0.67|1.62|||Log Rank||Droxidopa / Placebo|||1.62|0.67|0.803
71746887|NCT03400475|143002699|SUPERIORITY||Mean Difference (Final Values)|-2.088||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71746888|NCT03400475|143002700|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71779771|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.86|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.31|-0.86|<0.001
71779772|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.158||0.026|TWO_SIDED|95.0|-0.66|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.04|-0.66|0.026
71779773|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.157|<|0.001|TWO_SIDED|95.0|-0.94|-0.32|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.32|-0.94|<0.001
71779774|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.159|<|0.001|TWO_SIDED|95.0|-0.9|-0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.27|-0.90|<0.001
71891255|NCT00190775|143304307|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.399
71746889|NCT03400475|143002701|SUPERIORITY||Mean Difference (Final Values)|3.596||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71746890|NCT03400475|143002702|SUPERIORITY||Mean Difference (Final Values)|-0.083||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71746891|NCT03400475|143002703|SUPERIORITY||Mean Difference (Final Values)|0.581||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71746892|NCT03400475|143002704|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.90
71746893|NCT03400475|143002705|SUPERIORITY||Mean Difference (Final Values)|-64.696||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71746894|NCT03400475|143002706|SUPERIORITY||Mean Difference (Final Values)|111.03||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71746895|NCT03400475|143002707|SUPERIORITY||Mean Difference (Final Values)|213.314||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.86
71666345|NCT03355469|142846954|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.237|TWO_SIDED|95.0|-1.66|6.42||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||6.42|-1.66|0.237
71779775|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.171||0.002|TWO_SIDED|95.0|-0.89|-0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.21|-0.89|0.002
71891256|NCT00190775|143304308|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.365
71891257|NCT00190775|143304308|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.620
71891258|NCT00190775|143304308|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.462
71746896|NCT03400475|143002708|SUPERIORITY||Mean Difference (Final Values)|37.356||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71746897|NCT03400475|143002709|SUPERIORITY||Mean Difference (Final Values)|1.6537||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71746898|NCT03400475|143002710|SUPERIORITY||Mean Difference (Final Values)|1.552||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.41
71746899|NCT03400475|143002711|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
71746900|NCT03400475|143002712|SUPERIORITY|||||||0.071|||||||Fisher Exact|||||||0.071
71746901|NCT03400475|143002713|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71746902|NCT03400475|143002714|SUPERIORITY|||||||0.062|||||||Fisher Exact|||||||0.062
71746903|NCT03400475|143002715|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
71746904|NCT03400475|143002716|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71746905|NCT02649556|143002782|OTHER||LS Mean Difference|1.75|||||TWO_SIDED|95.0|-0.16|3.65||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of HDL-C levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|3.65|-0.160|
71746906|NCT02649556|143002783|OTHER||LS Mean Difference|-0.413|||||TWO_SIDED|95.0|-0.694|-0.131||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of White Blood Cell counts between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|-0.131|-0.694|
71746907|NCT02649556|143002784|OTHER||LS Mean Difference|0.914|||||TWO_SIDED|95.0|-0.339|2.17||||||"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of LS Mean difference of FEV1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on original values with visit, baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|2.17|-0.339|
71746908|NCT02649556|143002785|OTHER||% Relative Reduction|3.11|||||TWO_SIDED|95.0|0.0231|6.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of sICAM-1 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|6.10|0.0231|
71746909|NCT02649556|143002786|OTHER||% Relative Reduction|3.44|||||TWO_SIDED|95.0|-8.74|14.3|||||Derived as 100 x (1-Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 11-DTXB2 levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|14.3|-8.74|
71746910|NCT02649556|143002787|OTHER||% Relative Reduction|7.15|||||TWO_SIDED|95.0|-1.03|14.7|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of 8-epi-PGF2α levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|14.7|-1.03|
71891259|NCT00190775|143304309|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Total Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.001
71746911|NCT02649556|143002788|OTHER||% Relative Reduction|46.3|||||TWO_SIDED|95.0|36.2|54.8|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of Total NNAL levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect|54.8|36.2|
71746912|NCT02649556|143002789|OTHER||% Relative Reduction|31.7|||||TWO_SIDED|95.0|23.3|39.1|||||Derived as 100 x (1 - Geometric LS Mean Ratio)|"The analysis will determine the effect of THS 2.2 compared to CC at Month 12 on the components of the smokers' health profile. This study has no formal pre-specified hypotheses associated with the study objectives. Estimates of THS 2.2 effect will be presented by mean of relative reduction of COHb levels between CC and THS 2.2 and related 95% CI."|Mixed model conducted on log-transformed values with visit, log-transformed baseline value and its interaction with visit, sex, Caucasian origin, product use pattern category and its interaction with visit, and other baseline covariates relevant for the specific clinical risk endpoint as fixed effect factors and site as a random effect.|39.1|23.3|
71746913|NCT02413918|143002802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_DEVIATION|20.0|<|0.0094|TWO_SIDED|||||p value is not adjusted for multiple comparisons (see above). A priori threshold for significance was p\<0.05.|t-test, 2 sided|||BISS Outcomes: Mean changes in depression and mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0094
71746914|NCT02413918|143002802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||BISS Outcomes: Mean changes in mania for study completers were measured. The a priori hypothesis was a mean change of 50%.||||<0.0001
71746915|NCT01342913|143002810|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.282|TWO_SIDED|95.0|-0.018|0.063|||ANCOVA|||||0.063|-0.018|0.282
71746916|NCT03112681|143002817|SUPERIORITY|||||||0.0001|||||||paired t-test|||||||0.0001
71746917|NCT03112681|143002817|SUPERIORITY|||||||0.0002|||||||paired t-test|||||||0.0002
71746918|NCT04024891|143002818|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.7|||Mixed Models Analysis|||||-0.7|-1.3|<0.0001
71746919|NCT00453154|143002839|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis|Hazard Ratio (HR)|1.62||||0.02|TWO_SIDED|70.0|1.27|2.08||All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (\< 6 vs 6 cycles)|Log Rank|||||2.08|1.27|0.02
71746920|NCT01790594|143002846|SUPERIORITY||Mean Difference (Final Values)|2.088||||0.75|TWO_SIDED|95.0|-11.067|15.242|||Mixed Models Analysis|||The p-value compares Investigational arm and control arm.||15.242|-11.067|0.750
71746921|NCT02152631|143002884|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.771|TWO_SIDED|95.0|0.768|1.219|||Stratified Log-Rank||Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.|The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS \[G12C\] vs. all others)||1.219|0.768|0.771
71746922|NCT02152631|143002885|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|||Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS \[G12C\] vs. all others)||||0.010
71746923|NCT02152631|143002886|SUPERIORITY||Hazard Ratio (HR)|0.583|||<|1e-06|TWO_SIDED|95.0|0.47|0.723|||Stratified Log-Rank|||||0.723|0.470|<0.000001
71746924|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.19||0.698|TWO_SIDED|95.0|-0.44|0.29|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Headache||0.29|-0.44|0.698
71746925|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|0.59|STANDARD_ERROR_OF_MEAN|0.28||0.038|TWO_SIDED|95.0|0.03|1.15|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Diarrhea||1.15|0.03|0.038
71746926|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.94|-1.86|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Rash||-1.86|-2.94|<.001
71746927|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.142|TWO_SIDED|95.0|-0.56|0.08|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Symptom Severity||0.08|-0.56|0.142
71746928|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.514|TWO_SIDED|95.0|-0.59|0.3|||Mixed Models Analysis|Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Interference||0.30|-0.59|0.514
71746929|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Lung Cancer||0.23|-0.37|0.646
71779776|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.171|<|0.001|TWO_SIDED|95.0|-1.07|-0.39|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.39|-1.07|<0.001
71891260|NCT00190775|143304309|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyperactivity Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.004
71746930|NCT02152631|143002887|SUPERIORITY||LS Mean Change Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.188|TWO_SIDED|95.0|-0.51|0.1|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment\*Visit + Baseline.||Mean Core Plus Lung Cancer||0.10|-0.51|0.188
71746931|NCT02152631|143002889|SUPERIORITY||LS Mean Change Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.951|TWO_SIDED|95.0|-0.05|0.05|||Mixed Models Analysis|Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment\*Visit + Baseline.||||0.05|-0.05|0.951
71746932|NCT03776747|143002902|OTHER|Analysis of variance between lung inflation levels|||||<|0.001|||||||ANOVA|||We hypothesized that the anisotropic deformation index (ADC) is dependent upon lung inflation level. (Thus, it is important to standardize lung inflation when using this method)||||<0.001
71746933|NCT02210000|143002907|SUPERIORITY||Median Difference (Net)|-0.212||||0.017|TWO_SIDED|95.0|-0.3716|-0.0448||Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.|Bayesian method|||||-0.0448|-0.3716|0.017
71746934|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.2353|0.6553|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6553|-0.2353|
71779777|NCT01786668|143059370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.172|<|0.001|TWO_SIDED|95.0|-1.03|-0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.35|-1.03|<0.001
71779778|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.24|STANDARD_ERROR_OF_MEAN|7.99||0.159|TWO_SIDED|95.0|-4.41|26.89|||Normal approximation for two proportions|||Week 2||26.89|-4.41|0.159
71779779|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.39|STANDARD_ERROR_OF_MEAN|8.6|<|0.001|TWO_SIDED|95.0|15.54|49.24|||Normal approximation for two proportions|||Week 2||49.24|15.54|<0.001
71746935|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.749|||||TWO_SIDED|95.0|0.2275|1.2705|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.2705|0.2275|
71746936|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.489|||||TWO_SIDED|95.0|-0.0592|1.0374|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||1.0374|-0.0592|
71746937|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.497|||||TWO_SIDED|95.0|0.0396|0.955|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9550|0.0396|
71779780|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|STANDARD_ERROR_OF_MEAN|8.5||0.004|TWO_SIDED|95.0|8.04|41.36|||Normal approximation for two proportions|||Week 2||41.36|8.04|0.004
71779781|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.7|STANDARD_ERROR_OF_MEAN|8.82||0.01|TWO_SIDED|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 4||39.99|5.41|0.010
71891261|NCT00190775|143304309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71746938|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.3386|0.4395|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.4395|-0.3386|
71779782|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.08|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|20.79|55.38|||Normal approximation for two proportions|||Week 4||55.38|20.79|<0.001
71779783|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|32.32|STANDARD_ERROR_OF_MEAN|8.88|<|0.001|TWO_SIDED|95.0|14.9|49.73|||Normal approximation for two proportions|||Week 4||49.73|14.90|<0.001
71779784|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.82|STANDARD_ERROR_OF_MEAN|9.39||0.114|TWO_SIDED|95.0|-3.58|33.22|||Normal approximation for two proportions|||Week 8||33.22|-3.58|0.114
71779785|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
71779786|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.2|STANDARD_ERROR_OF_MEAN|9.33||0.001|TWO_SIDED|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8||48.49|11.92|0.001
71779787|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.47|STANDARD_ERROR_OF_MEAN|9.33||0.009|TWO_SIDED|95.0|6.18|42.76|||Normal approximation for two proportions|||Week 12||42.76|6.18|0.009
71779788|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.01|STANDARD_ERROR_OF_MEAN|9.15|<|0.001|TWO_SIDED|95.0|18.09|53.94|||Normal approximation for two proportions|||Week 12||53.94|18.09|<0.001
71779789|NCT01786668|143059371|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.32|STANDARD_ERROR_OF_MEAN|9.3||0.002|TWO_SIDED|95.0|10.09|46.55|||Normal approximation for two proportions|||Week 12||46.55|10.09|0.002
71779790|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
71779791|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
71779792|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2||13.91|-2.45|0.170
71666346|NCT03355469|142846954|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.486|TWO_SIDED|95.0|-2.8|5.7||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.70|-2.80|0.486
71666347|NCT03355469|142846954|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.081|TWO_SIDED|95.0|-0.53|8.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention FMD.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention 0 min unscaled FMD change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.19|-0.53|0.081
71666348|NCT03355469|142846955|SUPERIORITY||Mean Difference (Final Values)|0.0073||||0.373|TWO_SIDED|95.0|-0.0093|0.024||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0240|-0.0093|0.373
71779793|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
71779794|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.66|STANDARD_ERROR_OF_MEAN|5.52||0.306|TWO_SIDED|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4||16.48|-5.17|0.306
71779795|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.5|STANDARD_ERROR_OF_MEAN|5.99||0.113|TWO_SIDED|95.0|-2.24|21.24|||Normal approximation for two proportions|||Week 4||21.24|-2.24|0.113
71666349|NCT03355469|142846955|SUPERIORITY||Mean Difference (Final Values)|0.0097||||0.198|TWO_SIDED|95.0|-0.0055|0.025||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0250|-0.0055|0.198
71746939|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|-0.038|||||TWO_SIDED|95.0|-0.3242|0.2492|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.2492|-0.3242|
71746940|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-0.0483|0.9978|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9978|-0.0483|
71746941|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.461|||||TWO_SIDED|95.0|-0.0519|0.9748|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9748|-0.0519|
71779796|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.73|STANDARD_ERROR_OF_MEAN|6.08||0.775|TWO_SIDED|95.0|-10.18|13.65|||Normal approximation for two proportions|||Week 8||13.65|-10.18|0.775
71779797|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.12|STANDARD_ERROR_OF_MEAN|7.43||0.021|TWO_SIDED|95.0|2.56|31.68|||Normal approximation for two proportions|||Week 8||31.68|2.56|0.021
71779798|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.27|STANDARD_ERROR_OF_MEAN|7.17||0.064|TWO_SIDED|95.0|-0.79|27.34|||Normal approximation for two proportions|||Week 8||27.34|-0.79|0.064
71779799|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.47|STANDARD_ERROR_OF_MEAN|7.09||0.292|TWO_SIDED|95.0|-6.42|21.36|||Normal approximation for two proportions|||Week 12||21.36|-6.42|0.292
71779800|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.31|STANDARD_ERROR_OF_MEAN|7.38||0.125|TWO_SIDED|95.0|-3.16|25.78|||Normal approximation for two proportions|||Week 12||25.78|-3.16|0.125
71779801|NCT01786668|143059372|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.24|STANDARD_ERROR_OF_MEAN|7.51||0.078|TWO_SIDED|95.0|-1.49|27.96|||Normal approximation for two proportions|||Week 12||27.96|-1.49|0.078
71779802|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
71779803|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
71779804|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.92|STANDARD_ERROR_OF_MEAN|1.9||0.313|TWO_SIDED|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2||5.66|-1.81|0.313
71779805|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 4||5.29|-5.37|0.989
71779806|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 4||11.20|-3.58|0.313
71779807|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.73|STANDARD_ERROR_OF_MEAN|4.17||0.17|TWO_SIDED|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 4||13.91|-2.45|0.170
71891262|NCT00190775|143304309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71834948|NCT02376790|143174530|SUPERIORITY||Treatment Difference|11.6||||0.005|TWO_SIDED|95.0|4.2|18.9||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.||18.9|4.2|0.005
71834949|NCT02376790|143174532|SUPERIORITY||Treatment Difference|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||23.0|6.4|<0.001
71834950|NCT02376790|143174532|SUPERIORITY||Treatment Difference|11.8||||0.006|TWO_SIDED|95.0|3.4|20.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.||20.2|3.4|0.006
71834951|NCT02376790|143174533|SUPERIORITY||Treatment Difference|13.4|||<|0.001|TWO_SIDED|95.0|6.5|20.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.4|6.5|<0.001
71834952|NCT02376790|143174533|SUPERIORITY||Treatment Difference|13.7|||<|0.001|TWO_SIDED|95.0|6.7|20.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.||20.7|6.7|<0.001
71834953|NCT02376790|143174542|SUPERIORITY||LS Mean Treatment Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.91|-0.34||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.91|<0.001
71834954|NCT02376790|143174542|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.92|-0.34||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24||-0.34|-0.92|<0.001
71834955|NCT02376790|143174543|SUPERIORITY||LS Mean Treatment Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.18||0.59|TWO_SIDED|95.0|-2.93|1.68||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||1.68|-2.93|0.59
71834956|NCT02376790|143174543|SUPERIORITY||LS Mean Treatment Difference|-1.32|STANDARD_ERROR_OF_MEAN|1.18||0.26|TWO_SIDED|95.0|-3.63|0.99||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24||0.99|-3.63|0.26
71834957|NCT02376790|143174544|SUPERIORITY||LS Mean Treatment Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.2||0.41|TWO_SIDED|95.0|-3.35|1.38||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||1.38|-3.35|0.41
71834958|NCT02376790|143174544|SUPERIORITY||LS Mean Treatment Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.21||0.15|TWO_SIDED|95.0|-4.09|0.65||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24||0.65|-4.09|0.15
71834959|NCT02376790|143174545|SUPERIORITY||LS Mean Treatment Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED|95.0|-0.52|-0.07||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.07|-0.52|0.010
71834960|NCT02376790|143174545|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.62|-0.17||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24||-0.17|-0.62|<0.001
71891263|NCT00190775|143304309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Hyperactivity Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71891264|NCT00190775|143304309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Inattention Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71891265|NCT00190775|143304310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 8 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71746942|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.536|||||TWO_SIDED|95.0|0.0967|0.9745|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9745|0.0967|
71746943|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.196|||||TWO_SIDED|95.0|-0.2746|0.6671|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.6671|-0.2746|
71746944|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.314|||||TWO_SIDED|95.0|-0.2013|0.8292|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.8292|-0.2013|
71746945|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.384|||||TWO_SIDED|95.0|-0.0323|0.7997|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7997|-0.0323|
71746946|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.068|||||TWO_SIDED|95.0|-0.2366|0.3723|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.3723|-0.2366|
71746947|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.548|||||TWO_SIDED|95.0|0.1333|0.9628|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9628|0.1333|
71746948|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.479|||||TWO_SIDED|95.0|-0.0386|0.9966|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.9966|-0.0386|
71779808|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.81|STANDARD_ERROR_OF_MEAN|3.77||0.313|TWO_SIDED|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 8||11.20|-3.58|0.313
71779809|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.72||0.989|TWO_SIDED|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 8||5.29|-5.37|0.989
71779810|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.65|STANDARD_ERROR_OF_MEAN|4.53||0.091|TWO_SIDED|95.0|-1.22|16.52|||Normal approximation for two proportions|||Week 8||16.52|-1.22|0.091
71779811|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
71834961|NCT02376790|143174546|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.34|TWO_SIDED|95.0|-0.15|0.05||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.05|-0.15|0.34
71779812|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.62|STANDARD_ERROR_OF_MEAN|6.05||0.353|TWO_SIDED|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12||17.47|-6.23|0.353
71779813|NCT01786668|143059373|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.54|STANDARD_ERROR_OF_MEAN|6.26||0.228|TWO_SIDED|95.0|-4.73|19.81|||Normal approximation for two proportions|||Week 12||19.81|-4.73|0.228
71779814|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.926|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.58|-0.64|0.926
71779815|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.308||0.718|TWO_SIDED|95.0|-0.72|0.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.50|-0.72|0.718
71779816|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.57|TWO_SIDED|95.0|-0.43|0.79|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.79|-0.43|0.570
71779817|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.343||0.384|TWO_SIDED|95.0|-0.97|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.38|-0.97|0.384
71779818|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.341||0.334|TWO_SIDED|95.0|-1.0|0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.34|-1.00|0.334
71834962|NCT02376790|143174546|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.67|TWO_SIDED|95.0|-0.12|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.12|0.67
71891266|NCT00190775|143304310|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||<0.001
71891267|NCT00190775|143304311|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P-Value for 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.553
71891268|NCT00190775|143304311|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.797
71891269|NCT00190775|143304312|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-Value for State Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.108
71891270|NCT00190775|143304312|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-Value for Trait Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.026
71891271|NCT00190775|143304312|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-Value is for State Anxiety Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.897
71891272|NCT00190775|143304312|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||P-Value is for Trait Anxiety Score at 24 weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.||||||0.171
71666350|NCT03355469|142846955|SUPERIORITY||Mean Difference (Final Values)|0.0041||||0.622|TWO_SIDED|95.0|-0.0129|0.0211||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0211|-0.0129|0.622
71891273|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.892
71891274|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.003
71746949|NCT02210000|143002908|SUPERIORITY||Mean Difference (Net)|0.356|||||TWO_SIDED|95.0|-0.0049|0.7179|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.||0.7179|-0.0049|
71746950|NCT00308139|143002937|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.107||0.0023|TWO_SIDED|95.0|-0.54|-0.12|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.||-0.12|-0.54|0.0023
71746951|NCT00308139|143002940|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.0003
71746952|NCT00308139|143002942|SUPERIORITY_OR_OTHER|||||||0.2042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target value of \<=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.2042
71891275|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.007
71891276|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.533||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.533
71891277|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.054
71891278|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.012
71891279|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.457
71891280|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.001
71891281|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.021
71891282|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.710
71891283|NCT00190775|143304313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||<0.001
71891284|NCT00190775|143304313|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
71891285|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.722
71746953|NCT00308139|143002944|SUPERIORITY_OR_OTHER|||||||0.1513|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||0.1513
71746954|NCT00308139|143002946|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|30.08|STANDARD_ERROR_OF_MEAN|11.458||0.0124|TWO_SIDED|95.0|6.88|53.28|||ANCOVA|||Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.||53.28|6.88|0.0124
71746955|NCT00308139|143002948|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.612||0.8916|TWO_SIDED|95.0|-1.29|1.12|||ANCOVA|||Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||1.12|-1.29|0.8916
71779819|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.343||0.474|TWO_SIDED|95.0|-0.92|0.43|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.43|-0.92|0.474
71779820|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.381||0.445|TWO_SIDED|95.0|-1.04|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.46|-1.04|0.445
71779821|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.38||0.174|TWO_SIDED|95.0|-1.27|0.23|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.23|-1.27|0.174
71779822|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.383||0.217|TWO_SIDED|95.0|-1.23|0.28|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.28|-1.23|0.217
71779823|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.396||0.024|TWO_SIDED|95.0|-1.69|-0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.12|-1.69|0.024
71779824|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.396||0.01|TWO_SIDED|95.0|-1.81|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.24|-1.81|0.010
71779825|NCT01786668|143059374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.399||0.038|TWO_SIDED|95.0|-1.62|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.04|-1.62|0.038
71779826|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.15|STANDARD_ERROR_OF_MEAN|6.75||0.539|TWO_SIDED|95.0|-17.38|9.08|||Normal approximation for two proportions|||Week 2||9.08|-17.38|0.539
71779827|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.47|STANDARD_ERROR_OF_MEAN|7.62||0.473|TWO_SIDED|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 2||20.40|-9.46|0.473
71779828|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.22|STANDARD_ERROR_OF_MEAN|6.95||0.749|TWO_SIDED|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2||11.40|-15.85|0.749
71779829|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
71779830|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.51|STANDARD_ERROR_OF_MEAN|8.2||0.854|TWO_SIDED|95.0|-14.57|17.59|||Normal approximation for two proportions|||Week 4||17.59|-14.57|0.854
71779831|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.52||0.393|TWO_SIDED|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4||23.98|-9.43|0.393
71779832|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.16|STANDARD_ERROR_OF_MEAN|9.09||0.43|TWO_SIDED|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8||24.97|-10.65|0.430
71779833|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.24|STANDARD_ERROR_OF_MEAN|9.02||0.561|TWO_SIDED|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 8||22.92|-12.44|0.561
71779834|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.93|STANDARD_ERROR_OF_MEAN|9.24||0.162|TWO_SIDED|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 8||31.04|-5.17|0.162
71779835|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.62|STANDARD_ERROR_OF_MEAN|9.11||0.013|TWO_SIDED|95.0|4.76|40.49|||Normal approximation for two proportions|||Week 12||40.49|4.76|0.013
71779836|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
71779837|NCT01786668|143059375|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.78|STANDARD_ERROR_OF_MEAN|9.07||0.038|TWO_SIDED|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12||36.55|1.01|0.038
71779838|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.272||0.164|TWO_SIDED|95.0|-0.92|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.16|-0.92|0.164
71746956|NCT00308139|143002950|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-24.4|-9.4|||ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.4|-24.4|<.0001
71746957|NCT00308139|143002954|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|3.04||0.0077|TWO_SIDED|95.0|-14.1|-2.2|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-2.2|-14.1|0.0077
71746958|NCT00308139|143002956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.74||0.5613|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||1.9|-1.0|0.5613
71891286|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.011
71891287|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
71891288|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-Value for Hyper/Impulsive Scale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.779
71779839|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.271||0.129|TWO_SIDED|95.0|-0.95|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.95|0.129
71779840|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.272||0.66|TWO_SIDED|95.0|-0.66|0.42|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.42|-0.66|0.660
71779841|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.297||0.256|TWO_SIDED|95.0|-0.92|0.25|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.25|-0.92|0.256
71779842|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.296||0.048|TWO_SIDED|95.0|-1.17|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.00|-1.17|0.048
71779843|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.297||0.318|TWO_SIDED|95.0|-0.88|0.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.29|-0.88|0.318
71779844|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.35||0.522|TWO_SIDED|95.0|-0.92|0.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.47|-0.92|0.522
71779845|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.35||0.05|TWO_SIDED|95.0|-1.38|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.00|-1.38|0.050
71779846|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.352||0.337|TWO_SIDED|95.0|-1.03|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.36|-1.03|0.337
71779847|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.373||0.214|TWO_SIDED|95.0|-1.2|0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.27|-1.20|0.214
71779848|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.372||0.011|TWO_SIDED|95.0|-1.69|-0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.22|-1.69|0.011
71779849|NCT01786668|143059376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.375||0.031|TWO_SIDED|95.0|-1.55|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-1.55|0.031
71779850|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.106||0.982|TWO_SIDED|95.0|-0.21|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.21|-0.21|0.982
71779851|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.151|TWO_SIDED|95.0|-0.36|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.06|-0.36|0.151
71891289|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
71891290|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.002
71779852|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.106||0.205|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.07|-0.34|0.205
71779853|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.118||0.898|TWO_SIDED|95.0|-0.25|0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.22|-0.25|0.898
71746959|NCT00308139|143002959|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.042||0.2915|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2915
71746960|NCT00833040|143002965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.3|STANDARD_ERROR_OF_MEAN|4.49|<|0.001||95.0|||||ANCOVA|||difference between the active and placebo groups||||<0.001
71746961|NCT02748863|143002988|SUPERIORITY||Odds Ratio (OR)|717.42|||<|0.0001|TWO_SIDED|95.0|68.0|7569.56|||Regression, Logistic|||||7569.56|68.00|< 0.0001
71746962|NCT02748863|143002989|SUPERIORITY||Odds Ratio (OR)|168.39|||<|0.0001|TWO_SIDED|95.0|21.2|1337.22|||Regression, Logistic|||||1337.22|21.20|< 0.0001
71746963|NCT02748863|143002990|SUPERIORITY||Risk Difference (RD)|38.75|||<|0.0001|TWO_SIDED|95.0|27.41|50.09|||t-test, 2 sided|||||50.09|27.41|< 0.0001
71746964|NCT02748863|143002990|SUPERIORITY||Risk Difference (RD)|36.48|||<|0.0001|TWO_SIDED|95.0|25.19|47.76|||t-test, 2 sided|||||47.76|25.19|< 0.0001
71746965|NCT02748863|143002992|SUPERIORITY||Odds Ratio (OR)|400.58|||<|0.0001|TWO_SIDED|95.0|47.48|3379.99|||Regression, Logistic|||||3379.99|47.48|< 0.0001
71746966|NCT00867165|143002993|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.74|||<|0.001|TWO_SIDED|95.0|-30.8|-22.69|||ANCOVA|||||-22.69|-30.80|<0.001
71746967|NCT00867165|143002994|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.92|||<|0.001|TWO_SIDED|95.0|-24.2|-17.65|||ANCOVA|||||-17.65|-24.20|<0.001
71746968|NCT00867165|143002995|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.24|||<|0.001|TWO_SIDED|95.0|-24.02|-16.45|||ANCOVA|||||-16.45|-24.02|<0.001
71746969|NCT00867165|143002996|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.807|TWO_SIDED|95.0|-4.97|6.36|||ANCOVA|||||6.36|-4.97|0.807
71746970|NCT00867165|143002997|SUPERIORITY_OR_OTHER_LEGACY||Differrence in least-squares means|-25.75|||<|0.001|TWO_SIDED|95.0|-29.59|-21.91|||ANCOVA|||||-21.91|-29.59|<0.001
71746971|NCT00867165|143002998|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-14.68||||0.021|TWO_SIDED|95.0|-27.35|-2.0|||Constrained longitudinal data analysis|||||-2.00|-27.35|0.021
71746972|NCT00867165|143002999|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.97|||<|0.001|TWO_SIDED|95.0|-28.95|-20.99|||ANCOVA|||||-20.99|-28.95|<0.001
71746973|NCT00867165|143003000|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-23.94|||<|0.001|TWO_SIDED|95.0|-27.49|-20.39|||ANCOVA|||||-20.39|-27.49|<0.001
71746974|NCT00867165|143003001|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-27.71|||<|0.001|TWO_SIDED|95.0|-31.7|-23.73|||ANCOVA|||||-23.73|-31.70|<0.001
71746975|NCT00867165|143003002|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.09|||<|0.001|TWO_SIDED|95.0|-23.3|-16.89|||ANCOVA|||||-16.89|-23.30|<0.001
71746976|NCT00867165|143003003|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.27|||<|0.001|TWO_SIDED|95.0|-23.39|-17.15|||ANCOVA|||||-17.15|-23.39|<0.001
71746977|NCT00867165|143003004|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-21.37|||<|0.001|TWO_SIDED|95.0|-24.67|-18.08|||ANCOVA|||||-18.08|-24.67|<0.001
71746978|NCT00867165|143003005|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-0.95||||0.733|TWO_SIDED|95.0|-6.46|4.55|||ANCOVA|||||4.55|-6.46|0.733
71746979|NCT00867165|143003006|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.53||||0.863|TWO_SIDED|95.0|-5.59|6.66|||ANCOVA|||||6.66|-5.59|0.863
71746980|NCT00867165|143003007|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.92||||0.501|TWO_SIDED|95.0|-3.71|7.56|||ANCOVA|||||7.56|-3.71|0.501
71746981|NCT00867165|143003008|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.18|||<|0.001|TWO_SIDED|95.0|-27.78|-20.58|||ANCOVA|||||-20.58|-27.78|<0.001
71746982|NCT00867165|143003009|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.61|||<|0.001|TWO_SIDED|95.0|-28.06|-21.16|||ANCOVA|||||-21.16|-28.06|<0.001
71746983|NCT00867165|143003010|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-26.55|||<|0.001|TWO_SIDED|95.0|-30.35|-22.75|||ANCOVA|||||-22.75|-30.35|<0.001
71746984|NCT00867165|143003011|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-9.73||||0.137|TWO_SIDED|95.0|-22.73|3.27|||Constrained longitudinal data analysis|||||3.27|-22.73|0.137
71746985|NCT00867165|143003012|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-15.19||||0.005|TWO_SIDED|95.0|-26.05|-4.34|||Constrained longitudinal data analysis|||||-4.34|-26.05|0.005
71746986|NCT00867165|143003013|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-8.61||||0.149|TWO_SIDED|95.0|-20.44|3.23|||Constrained longitudinal data analysis|||||3.23|-20.44|0.149
71746987|NCT00867165|143003014|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-1.91||||0.373|TWO_SIDED|95.0|-6.15|2.32|||ANCOVA|||||2.32|-6.15|0.373
71746988|NCT00867165|143003015|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-19.76|||<|0.001|TWO_SIDED|95.0|-24.7|-14.82|||ANCOVA|||||-14.82|-24.70|<0.001
71746989|NCT00867165|143003016|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-20.83|||<|0.001|TWO_SIDED|95.0|-25.59|-16.07|||ANCOVA|||||-16.07|-25.59|<0.001
71746990|NCT00867165|143003017|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-23.48|||<|0.001|TWO_SIDED|95.0|-29.0|-17.97|||ANCOVA|||||-17.97|-29.00|<0.001
71746991|NCT00867165|143003018|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-22.29|||<|0.001|TWO_SIDED|95.0|-27.25|-17.34|||ANCOVA|||||-17.34|-27.25|<0.001
71666351|NCT03355469|142846955|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.666|TWO_SIDED|95.0|-0.0136|0.0088||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0088|-0.0136|0.666
71891291|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.716
71891292|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.071
71891293|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.034
71891294|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.938||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.938
71891295|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.004
71891296|NCT00190775|143304314|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.005
71746992|NCT00867165|143003019|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-24.5|||<|0.001|TWO_SIDED|95.0|-29.88|-19.12|||ANCOVA|||||-19.12|-29.88|<0.001
71746993|NCT00867165|143003020|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-30.69|-19.62|||ANCOVA|||||-19.62|-30.69|<0.001
71746994|NCT00867165|143003021|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-29.31|||<|0.001|TWO_SIDED|95.0|-35.71|-22.91|||ANCOVA|||||-22.91|-35.71|<0.001
71746995|NCT00867165|143003022|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.35|||<|0.001|TWO_SIDED|95.0|-34.41|-22.29|||ANCOVA|||||-22.29|-34.41|<0.001
71746996|NCT00867165|143003023|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-19.28|||<|0.001|TWO_SIDED|95.0|-23.87|-14.7|||ANCOVA|||||-14.70|-23.87|<0.001
71891297|NCT00190775|143304315|SUPERIORITY_OR_OTHER|||||||0.546||95.0||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.546
71891298|NCT00190775|143304315|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.530
71891299|NCT00190775|143304315|SUPERIORITY_OR_OTHER|||||||0.569||95.0||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.569
71891300|NCT00190775|143304315|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||P-Vaue for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.||||||0.986
71746997|NCT00867165|143003024|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-46.11||||0.116|TWO_SIDED|95.0|-108.14|15.92|||Constrained longitudinal data analysis|||||15.92|-108.14|0.116
71746998|NCT00867165|143003025|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|17.27||||0.382|TWO_SIDED|95.0|-20.46|55.0|||Constrained longitudinal data analysis|||||55.00|-20.46|0.382
71746999|NCT00867165|143003026|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.61|||<|0.001|TWO_SIDED|95.0|-55.36|-43.87|||ANCOVA|||||-43.87|-55.36|<0.001
71747000|NCT00867165|143003027|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-58.52|||<|0.001|TWO_SIDED|95.0|-63.67|-53.38|||ANCOVA|||||-53.38|-63.67|<0.001
71747001|NCT00867165|143003028|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-61.02|||<|0.001|TWO_SIDED|95.0|-67.51|-54.53|||ANCOVA|||||-54.53|-67.51|<0.001
71891301|NCT00700804|143304356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_DEVIATION|2.5||0.05|||||||Mixed Models Analysis|Effects of calcium (Ca), protein \& their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)|Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.|||||0.05
71747002|NCT00867165|143003029|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.74||||0.001|TWO_SIDED|95.0|-73.22|-52.26|||ANCOVA|||||-52.26|-73.22|0.001
71747003|NCT00867165|143003030|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-49.48|||<|0.001|TWO_SIDED|95.0|-54.83|-44.14|||ANCOVA|||||-44.14|-54.83|<0.001
71747004|NCT00867165|143003031|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-57.99|||<|0.001|TWO_SIDED|95.0|-62.87|-53.11|||ANCOVA|||||-53.11|-62.87|<0.001
71747005|NCT00867165|143003032|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-62.6|||<|0.001|TWO_SIDED|95.0|-68.54|-56.66|||ANCOVA|||||-56.66|-68.54|<0.001
71747006|NCT00867165|143003033|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-64.67|||<|0.001|TWO_SIDED|95.0|-74.11|-55.23|||ANCOVA|||||-55.23|-74.11|<0.001
71747007|NCT00867165|143003034|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-18.35|||<|0.001|TWO_SIDED|95.0|-24.7|-11.99|||ANCOVA|||||-11.99|-24.70|<0.001
71891302|NCT01511445|143304357|NON_INFERIORITY|The noninferiority margin was specified as 15 NDI points (0-100 scale).|Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.96||0.641|TWO_SIDED|95.0|-7.3|4.5|||Fisher Exact||A negative value means that the PEEK change was slightly larger than the silicon nitride study arm.|The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.||4.5|-7.3|0.641
71891303|NCT01511445|143304358|NON_INFERIORITY|The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.||||||0.71|||||||Fisher Exact|||The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).||||0.710
71666352|NCT03355469|142846955|SUPERIORITY||Mean Difference (Final Values)|-0.0032||||0.634|TWO_SIDED|95.0|-0.0169|0.0104||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0104|-0.0169|0.634
71666353|NCT03355469|142846955|SUPERIORITY||Mean Difference (Final Values)|-0.0056||||0.336|TWO_SIDED|95.0|-0.0174|0.0062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention GIR.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention GIR, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.0062|-0.0174|0.336
71666354|NCT03355469|142846956|SUPERIORITY||Mean Difference (Final Values)|1.51||||0.671|TWO_SIDED|95.0|-5.68|8.69||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.69|-5.68|0.671
71666355|NCT03355469|142846956|SUPERIORITY||Mean Difference (Final Values)|-4.82||||0.17|TWO_SIDED|95.0|-11.84|2.19||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.19|-11.84|0.170
71891304|NCT04696861|143304359|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
71747008|NCT00867165|143003035|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-25.61|||<|0.001|TWO_SIDED|95.0|-31.2|-20.02|||ANCOVA|||||-20.02|-31.20|<0.001
71747009|NCT00867165|143003036|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-28.74|||<|0.001|TWO_SIDED|95.0|-34.89|-22.59|||ANCOVA|||||-22.59|-34.89|<0.001
71747010|NCT00867165|143003037|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-32.14|||<|0.001|TWO_SIDED|95.0|-40.38|-23.9|||ANCOVA|||||-23.90|-40.38|<0.001
71747011|NCT00867165|143003038|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|20.01||||0.001|TWO_SIDED|95.0|8.1|31.91|||ANCOVA|||||31.91|8.10|0.001
71779854|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.118||0.37|TWO_SIDED|95.0|-0.34|0.13|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.13|-0.34|0.370
71666356|NCT03355469|142846956|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.839|TWO_SIDED|95.0|-7.29|5.97||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||5.97|-7.29|0.839
71666357|NCT03355469|142846956|SUPERIORITY||Mean Difference (Final Values)|6.33||||0.024|TWO_SIDED|95.0|0.86|11.8||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||11.80|0.86|0.024
71747012|NCT00867165|143003039|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|26.29|||<|0.001|TWO_SIDED|95.0|13.99|38.58|||ANCOVA|||||38.58|13.99|<0.001
71747013|NCT00867165|143003040|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|36.7|||<|0.001|TWO_SIDED|95.0|24.12|49.28|||ANCOVA|||||49.28|24.12|<0.001
71747014|NCT00867165|143003041|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|24.05|||<|0.001|TWO_SIDED|95.0|10.43|37.67|||ANCOVA|||||37.67|10.43|<0.001
71779855|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.119||0.288|TWO_SIDED|95.0|-0.36|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.11|-0.36|0.288
71747015|NCT03550378|143003065|SUPERIORITY||LS Mean Difference|-30.384|||<|0.001|TWO_SIDED|90.0|-41.27|-19.498|||ANCOVA|||||-19.498|-41.270|<0.001
71747016|NCT03546621|143003086|SUPERIORITY||||||<|0.0001|||||||Bonferroni-Holm|||For each of the three Myrcludex B treatment groups, a null hypothesis of no clinically significant difference in proportion of responders compared to the control group (Tenofovir only), at week 24, were tested using the one-sided Wald test for superiority, at a one-sided overall significance level of 0.05 adjusted for multiple testing according to Bonferroni-Holm, with the superiority limit (test margin) set to 5%.||||<.0001
71747017|NCT03546621|143003087|SUPERIORITY|||||||0.9818||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.9818
71666358|NCT03355469|142846956|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.385|TWO_SIDED|95.0|-7.16|2.83||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||2.83|-7.16|0.385
71666359|NCT03355469|142846956|SUPERIORITY||Mean Difference (Final Values)|4.17||||0.08|TWO_SIDED|95.0|-0.53|8.86||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention AIx75.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention AIx75 change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||8.86|-0.53|0.080
71666360|NCT03355469|142846957|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.088|TWO_SIDED|95.0|-0.069|0.005||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.005|-0.069|0.088
71666361|NCT03355469|142846957|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.96|TWO_SIDED|95.0|-0.059|0.062||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.062|-0.059|0.960
71666362|NCT03355469|142846957|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.075|TWO_SIDED|95.0|-0.109|0.006||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.006|-0.109|0.075
71666363|NCT03355469|142846957|SUPERIORITY||Mean Difference (Final Values)|-0.033||||0.258|TWO_SIDED|95.0|-0.094|0.028||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.028|-0.094|0.258
71747018|NCT03546621|143003087|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value as smaller than 0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||1.0000
71747019|NCT03546621|143003087|SUPERIORITY|||||||0.7132||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.||||0.7132
71747020|NCT03546621|143003088|SUPERIORITY|||||||0.0232||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.~This analysis, and presentation of descriptive statistics, was repeated for the subgroups of patients with normal/abnormal baseline ALT values."||||0.0232
71747021|NCT03546621|143003088|SUPERIORITY|||||||0.0047||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0047
71747022|NCT03546621|143003088|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.||||0.0010
71747023|NCT03546621|143003089|SUPERIORITY|||||||0.1642||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to week 24 and week 48 in ALT levels was performed using van Elteren tests.~Fisher's exact test was used to test a null hypothesis of no difference in proportions (of patients with normal ALT values) against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.1642
71747024|NCT03546621|143003089|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
71747025|NCT03546621|143003089|SUPERIORITY|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24||||0.0428
71747026|NCT03546621|143003089|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Boferroni-Holm|||Week 48||||0.2388
71747027|NCT03546621|143003089|SUPERIORITY|||||||0.7157||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.7157
71747028|NCT03546621|143003089|SUPERIORITY|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.2388
71779856|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.242|TWO_SIDED|95.0|-0.42|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.11|-0.42|0.242
71779857|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.135||0.12|TWO_SIDED|95.0|-0.48|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.06|-0.48|0.120
71779858|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.031|TWO_SIDED|95.0|-0.56|-0.03|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||-0.03|-0.56|0.031
71747029|NCT03546621|143003090|SUPERIORITY|||||||0.7416||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||0.7416
71747030|NCT03546621|143003090|SUPERIORITY|||||||0.4434||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.4434
71747031|NCT03546621|143003090|SUPERIORITY|||||||0.7371||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24.||||0.7371
71747032|NCT03546621|143003090|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747033|NCT03546621|143003090|SUPERIORITY|||||||0.9441||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||0.9441
71747034|NCT03546621|143003090|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747035|NCT03546621|143003091|SUPERIORITY||Bonferroni-Holm|||||0.5984||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to Week 24 in HBsAg was performed using van Elteren tests. Tests were performed on log-10 transformed data.~Separare comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted values were computed using the Bonferroni-Holm method."||||0.5984
71747036|NCT03546621|143003091|SUPERIORITY|||||||0.7529||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.7529
71747037|NCT03546621|143003091|SUPERIORITY|||||||0.3305||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24||||0.3305
71747038|NCT03546621|143003091|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747039|NCT03546621|143003091|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747040|NCT03546621|143003091|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747041|NCT03546621|143003092|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Tests were performed on log-10 transformed data. Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni-Holm method."||||1.0000
71747042|NCT03546621|143003092|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24.||||1.0000
71747043|NCT03546621|143003092|SUPERIORITY|||||||1|||||||Bonferroni-Holm|||Week 24||||1.0000
71747044|NCT03546621|143003092|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 48||||1.0000
71747045|NCT03546621|143003092|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747046|NCT03546621|143003092|SUPERIORITY|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48||||1.0000
71747047|NCT03040141|143003105|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.9||||0.181|TWO_SIDED|95.0|1.03|13.55|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||13.55|1.03|0.181
71747048|NCT03040141|143003105|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.3||||0.073|TWO_SIDED|95.0|0.9|12.13|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||12.13|0.90|0.073
71747049|NCT03040141|143003105|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|3.5||||0.037|TWO_SIDED|95.0|1.08|11.48|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||11.48|1.08|0.037
71747050|NCT03040141|143003105|SUPERIORITY|The null hypothesis was defined as no treatment difference.|Odds Ratio (OR)|1.1||||0.814|TWO_SIDED|95.0|0.4|3.25|||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||3.25|0.40|0.814
71747051|NCT03040141|143003107|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.748||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level. The goal will be used to assess the strength of evidence to select the endpoints for a Phase 3 trial.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.748
71747052|NCT03040141|143003107|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference||||0.940
71747053|NCT03040141|143003107|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.902||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The total VIS410 high-dose group (high-dose + low-dose) was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.902
71747054|NCT03040141|143003107|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.283||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.283
71747055|NCT03040141|143003108|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.919||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.919
71747056|NCT03040141|143003108|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.9||||||p-value is not adjusted for multiple comparisons, which were performed at the 0.05 significance level.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 low-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.900
71747057|NCT03040141|143003108|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.99||||||p-value is not adjusted for multiple comparisons|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level||The combined VIS410 high- and low-dose groups was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.990
71834963|NCT02376790|143174547|SUPERIORITY||LS Mean Treatment Difference|1.94|STANDARD_ERROR_OF_MEAN|0.8||0.015|TWO_SIDED|95.0|0.37|3.51||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.51|0.37|0.015
71747058|NCT03040141|143003108|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.521||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||The VIS410 high-dose group was compared against the VIS410 low-dose group. The null hypothesis was defined as no treatment difference.||||0.521
71747059|NCT03040141|143003109|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|ANOVA|||The VIS410 high-dose group was compared against the placebo group. The null hypothesis was defined as no treatment difference.||||0.360
71747060|NCT03040141|143003110|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
71747061|NCT03040141|143003110|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.259|||||||ANOVA|||||||0.259
71747062|NCT03040141|143003110|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.644||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.644
71834964|NCT02376790|143174547|SUPERIORITY||LS Mean Treatment Difference|1.71|STANDARD_ERROR_OF_MEAN|0.8||0.033|TWO_SIDED|95.0|0.13|3.28||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24||3.28|0.13|0.033
71747063|NCT03040141|143003110|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.146|||||||ANOVA|||||||0.146
71747064|NCT03040141|143003111|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.624||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.624
71747065|NCT03040141|143003111|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.399||||||The p-value is not adjusted for multiple comparisons. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.|ANOVA|||||||0.399
71747066|NCT03040141|143003111|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.837|||||||ANOVA|||||||0.837
71747067|NCT03040141|143003111|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.183|||||||ANOVA|||||||0.183
71747068|NCT03040141|143003112|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.88|||||||ANOVA|||||||0.880
71747069|NCT03040141|143003112|SUPERIORITY|The null hypothesis was defined as no treatment difference||||||0.778|||||||ANOVA|||||||0.778
71747070|NCT03040141|143003112|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.94|||||||ANOVA|||||||0.940
71747071|NCT03040141|143003112|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.662|||||||ANOVA|||||||0.662
71747072|NCT03040141|143003113|OTHER|||||||0.64|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.640
71747073|NCT03040141|143003113|OTHER|||||||0.775|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.775
71747074|NCT03040141|143003113|OTHER|||||||0.701|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.701
71747075|NCT03040141|143003113|OTHER|||||||0.638|||||||Chi-squared|A Wald Chi-square statistic from a Cox proportional model was used for comparisons of treatment groups||||||0.638
71747076|NCT03040141|143003114|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
71747077|NCT03040141|143003114|OTHER|||||||1|||||||Regression, Logistic|||||||1.000
71779859|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.157||0.28|TWO_SIDED|95.0|-0.48|0.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.14|-0.48|0.280
71834965|NCT02376790|143174547|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.84||0.97|TWO_SIDED|95.0|-1.69|1.63||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.63|-1.69|0.97
71834966|NCT02376790|143174547|SUPERIORITY||LS Mean Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.85||0.56|TWO_SIDED|95.0|-2.16|1.16||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24||1.16|-2.16|0.56
71834967|NCT02376790|143174548|SUPERIORITY||LS Mean Treatment Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|-1.03|-0.09||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||-0.09|-1.03|0.020
71834968|NCT02376790|143174548|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1|TWO_SIDED|95.0|-0.88|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.08|-0.88|0.10
71834969|NCT02376790|143174550|SUPERIORITY||LS Mean Treatment Difference|13.92|STANDARD_ERROR_OF_MEAN|33.23||0.68|TWO_SIDED|95.0|-51.52|79.36||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||79.36|-51.52|0.68
71747078|NCT03040141|143003114|OTHER|||||||0.458|||||||Regression, Logistic|||||||0.458
71779860|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.157||0.099|TWO_SIDED|95.0|-0.57|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.05|-0.57|0.099
71779861|NCT01786668|143059377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.158||0.014|TWO_SIDED|95.0|-0.7|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.08|-0.70|0.014
71779862|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.387||0.895|TWO_SIDED|95.0|-0.81|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.71|-0.81|0.895
71779863|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.386||0.033|TWO_SIDED|95.0|-1.59|-0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.07|-1.59|0.033
71779864|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.388||0.044|TWO_SIDED|95.0|-1.55|-0.02|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||-0.02|-1.55|0.044
71779865|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.411||0.53|TWO_SIDED|95.0|-1.07|0.55|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.55|-1.07|0.530
71779866|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.411||0.114|TWO_SIDED|95.0|-1.46|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.16|-1.46|0.114
71834970|NCT02376790|143174550|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|33.05||0.85|TWO_SIDED|95.0|-58.75|71.42||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||71.42|-58.75|0.85
71747079|NCT03040141|143003114|OTHER|||||||0.127|||||||Regression, Logistic|||||||0.127
71747080|NCT03040141|143003115|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.371|||||||ANOVA|||||||0.371
71747081|NCT03040141|143003115|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.735|||||||ANOVA|||||||0.735
71747082|NCT03040141|143003115|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.476|||||||ANOVA|||||||0.476
71747083|NCT03040141|143003115|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.581|||||||ANOVA|||||||0.581
71747084|NCT03040141|143003116|OTHER|||||||0.98|||||||Regression, Logistic|||||||0.980
71747085|NCT03040141|143003116|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
71747086|NCT03040141|143003116|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
71747087|NCT03040141|143003116|OTHER|||||||0.955|||||||Regression, Logistic|||||||0.955
71747088|NCT03040141|143003117|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.695|||||||ANOVA|||||||0.695
71891305|NCT04696861|143304360|SUPERIORITY|||||||0.961||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.961
71666364|NCT03355469|142846957|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.443|TWO_SIDED|95.0|-0.075|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.075|0.443
71666365|NCT03355469|142846957|SUPERIORITY||Mean Difference (Final Values)|-0.053||||0.144|TWO_SIDED|95.0|-0.126|0.02||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBF.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBF change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.020|-0.126|0.144
71747089|NCT03040141|143003117|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.542|||||||ANOVA|||||||0.542
71747090|NCT03040141|143003117|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.899|||||||ANOVA|||||||0.899
71747091|NCT03040141|143003117|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.321|||||||ANOVA|||||||0.321
71747092|NCT03040141|143003118|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.663|||||||ANOVA|||||||0.663
71747093|NCT03040141|143003118|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.54|||||||ANOVA|||||||0.540
71747094|NCT03040141|143003118|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.918|||||||ANOVA|||||||0.918
71747095|NCT03040141|143003118|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.294|||||||ANOVA|||||||0.294
71747096|NCT03040141|143003120|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.25|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.250
71747097|NCT03040141|143003120|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.133|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.133
71747098|NCT03040141|143003120|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.177|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.177
71747099|NCT03040141|143003120|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.36|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.360
71747100|NCT03040141|143003121|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.636|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.636
71747101|NCT03040141|143003121|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.446|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.446
71747102|NCT03040141|143003121|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.53|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.530
71747103|NCT03040141|143003121|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.463|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.463
71747104|NCT03040141|143003122|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.152|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.152
71747105|NCT03040141|143003122|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.176|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.176
71747106|NCT03040141|143003122|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.157|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.157
71747107|NCT03040141|143003122|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.844|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||||||0.844
71747108|NCT03040141|143003123|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.531|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.531
71747109|NCT03040141|143003123|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.582|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.582
71666366|NCT03355469|142846958|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.147|TWO_SIDED|95.0|-0.017|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.017|0.147
71666367|NCT03355469|142846958|SUPERIORITY||Mean Difference (Final Values)|0.001||||0.943|TWO_SIDED|95.0|-0.016|0.017||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.017|-0.016|0.943
71747110|NCT03040141|143003123|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.55|||||||Chi-squared|Wald Chi-square statistic from a Cox proportional model is used for comparisons of treatment groups.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.550
71747111|NCT03040141|143003123|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.84|||||||Chi-squared|P-value determined based on Cox proportional hazards model Wald Chi-Square Statistic.||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.840
71747112|NCT03040141|143003124|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.3534|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.3534
71747113|NCT03040141|143003124|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7839|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7839
71747114|NCT03040141|143003124|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.4893|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.4893
71747115|NCT03040141|143003124|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5101|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5101
71747116|NCT03040141|143003125|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.5436|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.5436
71747117|NCT03040141|143003125|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.8215|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.8215
71747118|NCT03040141|143003125|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.6319|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.6319
71747119|NCT03040141|143003125|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.7011|||||||ANCOVA|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.7011
71747120|NCT03040141|143003126|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.478|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.478
71747121|NCT03040141|143003126|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.468|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.||||0.468
71747122|NCT03040141|143003126|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.412|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.412
71747123|NCT03040141|143003126|SUPERIORITY|The null hypothesis was defined as no treatment difference.||||||0.982|||||||Regression, Logistic|||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons||||0.982
71747124|NCT00462306|143003144|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05|Chi-squared, Corrected|||We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.||||0.001
71747125|NCT00462306|143003145|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
71747126|NCT03515824|143003146|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
71747127|NCT03515824|143003146|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|0.0|||||TWO_SIDED|80.0|0.0|33.1||||||||33.1|0.0|
71747128|NCT03515824|143003146|OTHER|Bayesian posterior credible interval|Pooled-adjacent-violator algorithm|15.4|||||TWO_SIDED|80.0|5.8|30.2||||||||30.2|5.8|
71747129|NCT03515824|143003149|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
71747130|NCT03515824|143003149|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|60.2||||||||60.2|0.0|
71747131|NCT03515824|143003149|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|21.8||||||||21.8|0.0|
71747132|NCT03515824|143003150|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|84.2||||||||84.2|0.0|
71747133|NCT03515824|143003150|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate (ORR)|0.0|||||TWO_SIDED|95.0|0.0|70.8||||||||70.8|0.0|
71747134|NCT03515824|143003150|OTHER|Clopper Pearson confidence interval method for binomial data|Objective Response Rate )ORR)|0.0|||||TWO_SIDED|95.0|0.0|28.5||||||||28.5|0.0|
71747135|NCT00550407|143003182|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||||||0.010
71747136|NCT05051579|143003198|SUPERIORITY||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-8.9|-4.2|||Mixed Models Analysis|||||-4.2|-8.9|<0.001
71891306|NCT04696861|143304361|SUPERIORITY|||||||0.368||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.368
71891307|NCT04696861|143304363|SUPERIORITY|||||||0.634||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.634
71891308|NCT04696861|143304364|SUPERIORITY|||||||0.832||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.832
71666368|NCT03355469|142846958|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.108|TWO_SIDED|95.0|-0.027|0.003||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.003|-0.027|0.108
71666369|NCT03355469|142846958|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.319|TWO_SIDED|95.0|-0.024|0.009||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.009|-0.024|0.319
71891309|NCT04696861|143304366|SUPERIORITY|||||||0.624||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||Generalized linear mixed models were conducted and odds ratios (ORs) were reported||||0.624
71891310|NCT04696861|143304367|SUPERIORITY|||||||0.833||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.833
71891311|NCT04696861|143304368|SUPERIORITY|||||||0.7||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.7
71747137|NCT05051579|143003198|SUPERIORITY||LS Mean difference (Final Values)|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
71747138|NCT05051579|143003198|SUPERIORITY||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.4|-8.0|||Mixed Models Analysis|||||-8.0|-12.4|<0.001
71747139|NCT05051579|143003198|SUPERIORITY||LS Mean difference (Final Values)|-10.6|||<|0.001|TWO_SIDED|95.0|-12.7|-8.4|||Mixed Models Analysis|||||-8.4|-12.7|<0.001
71747140|NCT05051579|143003199|OTHER||LS Mean difference (Final Values)|-7.1|||<|0.001|TWO_SIDED|95.0|-9.9|-4.2|||Mixed Models Analysis|||||-4.2|-9.9|<0.001
71747141|NCT05051579|143003199|OTHER||LS Mean difference (Final Values)|-10.1|||<|0.001|TWO_SIDED|95.0|-12.9|-7.3|||Mixed Models Analysis|||||-7.3|-12.9|<0.001
71747142|NCT05051579|143003199|OTHER||LS Mean difference (Final Values)|-11.1|||<|0.001|TWO_SIDED|95.0|-13.8|-8.4|||Mixed Models Analysis|||||-8.4|-13.8|<0.001
71747143|NCT05051579|143003199|OTHER||LS Mean difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-15.0|-9.6|||Mixed Models Analysis|||||-9.6|-15.0|<0.001
71834971|NCT02376790|143174551|SUPERIORITY||Treatment Difference|12.9||||0.057|TWO_SIDED|95.0|-0.4|26.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||26.2|-0.4|0.057
71834972|NCT02376790|143174551|SUPERIORITY||Treatment Difference|10.9||||0.12|TWO_SIDED|95.0|-2.5|24.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||24.4|-2.5|0.12
71834973|NCT02376790|143174552|SUPERIORITY||LS Mean Treatment Difference|0.16|STANDARD_ERROR_OF_MEAN|0.42||0.7|TWO_SIDED|95.0|-0.66|0.98||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.98|-0.66|0.70
71747144|NCT05051579|143003200|OTHER||LS Mean difference (Final Values)|-6.9|||<|0.001|TWO_SIDED|95.0|-9.3|-4.4|||Mixed Models Analysis|||||-4.4|-9.3|<0.001
71747145|NCT05051579|143003200|OTHER||LS Mean difference (Final Values)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.5|-7.8|||Mixed Models Analysis|||||-7.8|-12.5|<0.001
71747146|NCT05051579|143003200|OTHER||LS Mean difference (Final Values)|-10.8|||<|0.001|TWO_SIDED|95.0|-13.1|-8.5|||Mixed Models Analysis|||||-8.5|-13.1|<0.001
71747147|NCT05051579|143003200|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.9|||Mixed Models Analysis|||||-8.9|-13.5|<0.001
71747148|NCT05051579|143003201|OTHER||LS Mean difference (Final Values)|-7.4|||<|0.001|TWO_SIDED|95.0|-10.4|-4.3|||Mixed Models Analysis|||||-4.3|-10.4|<0.001
71747149|NCT05051579|143003201|OTHER||LS Mean difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.2|-8.3|||Mixed Models Analysis|||||-8.3|-14.2|<0.001
71747150|NCT05051579|143003201|OTHER||LS Mean difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-14.7|-9.0|||Mixed Models Analysis|||||-9.0|-14.7|<0.001
71747151|NCT05051579|143003201|OTHER||LS Mean difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-10.2|||Mixed Models Analysis|||||-10.2|-15.8|<0.001
71747152|NCT05051579|143003202|OTHER||LS Mean difference (Final Values)|-4.4||||0.002|TWO_SIDED|95.0|-7.2|-1.6|||Mixed Models Analysis|||||-1.6|-7.2|0.002
71747153|NCT05051579|143003202|OTHER||LS Mean difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-8.0|-2.4|||Mixed Models Analysis|||||-2.4|-8.0|<0.001
71779867|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.415||0.297|TWO_SIDED|95.0|-1.25|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.38|-1.25|0.297
71779868|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.37||0.377|TWO_SIDED|95.0|-1.06|0.4|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.40|-1.06|0.377
71779869|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.77|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.31|-1.77|0.006
71779870|NCT01786668|143059378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.373||0.017|TWO_SIDED|95.0|-1.64|-0.17|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||-0.17|-1.64|0.017
71779871|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.414||0.8|TWO_SIDED|95.0|-0.92|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.71|-0.92|0.800
71779872|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.413||0.113|TWO_SIDED|95.0|-0.16|1.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||1.47|-0.16|0.113
71779873|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.414||0.064|TWO_SIDED|95.0|-1.59|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.05|-1.59|0.064
71834974|NCT02376790|143174552|SUPERIORITY||LS Mean Treatment Difference|0.04|STANDARD_ERROR_OF_MEAN|0.42||0.93|TWO_SIDED|95.0|-0.79|0.86||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||0.86|-0.79|0.93
71834975|NCT02376790|143174553|SUPERIORITY||Treatment Difference|3.2||||0.55|TWO_SIDED|95.0|-7.3|13.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||13.7|-7.3|0.55
71834976|NCT02376790|143174553|SUPERIORITY||Treatment Difference|8.8||||0.11|TWO_SIDED|95.0|-1.9|19.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||19.4|-1.9|0.11
71891312|NCT04696861|143304369|SUPERIORITY|||||||0.79||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.79
71747154|NCT05051579|143003202|OTHER||LS Mean difference (Final Values)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.2|-3.8|||Mixed Models Analysis|||||-3.8|-9.2|<0.001
71747155|NCT05051579|143003202|OTHER||LS Mean difference (Final Values)|-8.7|||<|0.001|TWO_SIDED|95.0|-11.3|-6.0|||Mixed Models Analysis|||||-6.0|-11.3|<0.001
71747156|NCT05051579|143003203|OTHER||LS Mean difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.8|-2.4|||Mixed Models Analysis|||||-2.4|-8.8|<0.001
71747157|NCT05051579|143003203|OTHER||LS Mean difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.3|-4.0|||Mixed Models Analysis|||||-4.0|-10.3|<0.001
71779874|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.972|TWO_SIDED|95.0|-0.74|0.71|||Mixed Models Analysis|||Week 4||0.71|-0.74|0.972
71747158|NCT05051579|143003203|OTHER||LS Mean difference (Final Values)|-6.6|||<|0.001|TWO_SIDED|95.0|-9.7|-3.6|||Mixed Models Analysis|||||-3.6|-9.7|<0.001
71779875|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.368||0.44|TWO_SIDED|95.0|-0.44|1.01|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||1.01|-0.44|0.440
71779876|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.369||0.311|TWO_SIDED|95.0|-1.1|0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.35|-1.10|0.311
71779877|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.629||0.501|TWO_SIDED|95.0|-1.66|0.82|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.82|-1.66|0.501
71779878|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.629||0.543|TWO_SIDED|95.0|-1.63|0.86|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.86|-1.63|0.543
71834977|NCT02376790|143174554|SUPERIORITY||LS Mean Treatment Difference|9.36|STANDARD_ERROR_OF_MEAN|4.33||0.031|TWO_SIDED|95.0|0.85|17.87||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \>30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||17.87|0.85|0.031
71779879|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.636||0.287|TWO_SIDED|95.0|-1.93|0.57|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.57|-1.93|0.287
71779880|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.519||0.82|TWO_SIDED|95.0|-0.91|1.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.14|-0.91|0.820
71747159|NCT05051579|143003203|OTHER||LS Mean difference (Final Values)|-9.6|||<|0.001|TWO_SIDED|95.0|-12.7|-6.6|||Mixed Models Analysis|||||-6.6|-12.7|<0.001
71666370|NCT03355469|142846958|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.496|TWO_SIDED|95.0|-0.019|0.01||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.010|-0.019|0.496
71747160|NCT05051579|143003204|OTHER||LS Mean difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.2|-1.6|||Mixed Models Analysis|||||-1.6|-3.2|<0.001
71747161|NCT05051579|143003204|OTHER||LS Mean difference (Final Values)|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.6|||Mixed Models Analysis|||||-2.6|-4.3|<0.001
71747162|NCT05051579|143003204|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.6|3.0|||Mixed Models Analysis|||||3.0|-4.6|<0.001
71747163|NCT05051579|143003204|OTHER||LS Mean difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.7|-3.1|||Mixed Models Analysis|||||-3.1|-4.7|<0.001
71747164|NCT05051579|143003205|OTHER||LS Mean difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.6|-1.5|||Mixed Models Analysis|||||-1.5|-3.6|<0.001
71779881|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.711|TWO_SIDED|95.0|-0.83|1.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||1.22|-0.83|0.711
71779882|NCT01786668|143059380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.524||0.424|TWO_SIDED|95.0|-1.45|0.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.61|-1.45|0.424
71779883|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.203||0.785|TWO_SIDED|95.0|-0.34|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.46|-0.34|0.785
71779884|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.203||0.605|TWO_SIDED|95.0|-0.3|0.51|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.51|-0.30|0.605
71779885|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.204||0.175|TWO_SIDED|95.0|-0.68|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||0.12|-0.68|0.175
71779886|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.232||0.482|TWO_SIDED|95.0|-0.29|0.62|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.62|-0.29|0.482
71779887|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.231||0.288|TWO_SIDED|95.0|-0.7|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.70|0.288
71747165|NCT05051579|143003205|OTHER||LS Mean difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-4.8|-2.8|||Mixed Models Analysis|||||-2.8|-4.8|<0.001
71747166|NCT05051579|143003205|OTHER||LS Mean difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.2|-3.2|||Mixed Models Analysis|||||-3.2|-5.2|<0.001
71747167|NCT05051579|143003205|OTHER||LS Mean difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-5.6|-3.6|||Mixed Models Analysis|||||-3.6|-5.6|<0.001
71747168|NCT05051579|143003206|OTHER||Odds Ratio (OR)|9.96|||<|0.001|TWO_SIDED|95.0|3.61|27.44|||Regression, Logistic|||||27.44|3.61|<0.001
71747169|NCT05051579|143003206|OTHER||Odds Ratio (OR)|27.97|||<|0.001|TWO_SIDED|95.0|8.15|96.01|||Regression, Logistic|||||96.01|8.15|<0.001
71747170|NCT05051579|143003206|OTHER||Odds Ratio (OR)|27.36|||<|0.001|TWO_SIDED|95.0|8.71|85.91|||Regression, Logistic|||||85.91|8.71|<0.001
71747171|NCT05051579|143003206|OTHER||Odds Ratio (OR)|23.59|||<|0.001|TWO_SIDED|95.0|7.65|72.77|||Regression, Logistic|||||72.77|7.65|<0.001
71747172|NCT05051579|143003207|OTHER||Odds Ratio (OR)|19.93|||<|0.001|TWO_SIDED|95.0|3.47|114.4|||Regression, Logistic|||||114.40|3.47|<0.001
71747173|NCT05051579|143003207|OTHER||Odds Ratio (OR)|39.52|||<|0.001|TWO_SIDED|95.0|6.95|224.83|||Regression, Logistic|||||224.83|6.95|<0.001
71747174|NCT05051579|143003207|OTHER||Odds Ratio (OR)|74.97|||<|0.001|TWO_SIDED|95.0|13.16|427.18|||Regression, Logistic|||||427.18|13.16|<0.001
71747175|NCT05051579|143003207|OTHER||Odds Ratio (OR)|72.23|||<|0.001|TWO_SIDED|95.0|12.62|413.21|||Regression, Logistic|||||413.21|12.62|<0.001
71747176|NCT05051579|143003208|OTHER||Odds Ratio (OR)|7.79|||<|0.001|TWO_SIDED|95.0|2.9|20.92|||Regression, Logistic|||||20.92|2.90|<0.001
71747177|NCT05051579|143003208|OTHER||Odds Ratio (OR)|25.07|||<|0.001|TWO_SIDED|95.0|7.49|83.91|||Regression, Logistic|||||83.91|7.49|<0.001
71747178|NCT05051579|143003208|OTHER||Odds Ratio (OR)|34.76|||<|0.001|TWO_SIDED|95.0|8.17|147.86|||Regression, Logistic|||||147.86|8.17|<0.001
71747179|NCT05051579|143003208|OTHER||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|8.15|96.29|||Regression, Logistic|||||96.29|8.15|<0.001
71747180|NCT05051579|143003209|OTHER||Odds Ratio (OR)|8.27|||<|0.001|TWO_SIDED|95.0|2.59|26.45|||Regression, Logistic|||||26.45|2.59|<0.001
71834978|NCT02376790|143174554|SUPERIORITY||LS Mean Treatment Difference|3.02|STANDARD_ERROR_OF_MEAN|4.33||0.49|TWO_SIDED|95.0|-5.49|11.54||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|||11.54|-5.49|0.49
71834979|NCT02376790|143174555|SUPERIORITY||LS Mean Treatment Difference|15.95|STANDARD_ERROR_OF_MEAN|4.55|<|0.001|TWO_SIDED|95.0|6.99|24.9||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||24.90|6.99|<0.001
71834980|NCT02376790|143174555|SUPERIORITY||LS Mean Treatment Difference|6.97|STANDARD_ERROR_OF_MEAN|4.5||0.12|TWO_SIDED|95.0|-1.89|15.83||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.||15.83|-1.89|0.12
71834981|NCT02376790|143174560|SUPERIORITY||Treatment Difference|11.4||||0.019|TWO_SIDED|95.0|2.0|20.8||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||20.8|2.0|0.019
71834982|NCT02376790|143174560|SUPERIORITY||Treatment Difference|4.2||||0.4|TWO_SIDED|95.0|-5.6|14.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|||14.0|-5.6|0.40
71834983|NCT02376790|143174561|SUPERIORITY||Treatment Difference|20.1||||0.004|TWO_SIDED|95.0|6.8|33.3||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||33.3|6.8|0.004
71834984|NCT02376790|143174561|SUPERIORITY||Treatment Difference|17.1||||0.012|TWO_SIDED|95.0|4.0|30.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or \> 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.||30.2|4.0|0.012
71834985|NCT05450458|143174567|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for KOOS score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Change Baseline to month 6|0.22|||<|0.001|TWO_SIDED|95.0|0.15|0.23||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|Post hoc pairwise comparisons were adjusted using the Bonferroni method, and the a priori significance level was set at 0.05|The value represents the intra-individual median KOOS improvement from baseline to month 6 after treatment. Changes were evaluated across time points within a single cohort.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve KOOS function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.23|0.15|<0.001
71891313|NCT04696861|143304370|SUPERIORITY|||||||0.55||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.55
71891314|NCT04696861|143304371|SUPERIORITY|||||||0.823|||||||Mixed Models Analysis|||||||.823
71891315|NCT04696861|143304372|SUPERIORITY|||||||0.942|||||||Mixed Models Analysis|||||||.942
71747181|NCT05051579|143003209|OTHER||Odds Ratio (OR)|15.64|||<|0.001|TWO_SIDED|95.0|4.83|50.68|||Regression, Logistic|||||50.68|4.83|<0.001
71747182|NCT05051579|143003209|OTHER||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|8.39|88.38|||Regression, Logistic|||||88.38|8.39|<0.001
71747183|NCT05051579|143003209|OTHER||Odds Ratio (OR)|20.88|||<|0.001|TWO_SIDED|95.0|6.59|66.17|||Regression, Logistic|||||66.17|6.59|<0.001
71747184|NCT00871871|143003218|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.067|TWO_SIDED|90.0|-0.22|0.01||one-sided, alpha = 0.05|ANCOVA|||||0.01|-0.22|0.067
71747185|NCT00871871|143003219|SUPERIORITY_OR_OTHER||Least squares mean difference|1.1|||>|0.5|TWO_SIDED|90.0|0.86|1.34|||ANCOVA|||||1.34|0.86|>0.500
71747186|NCT00871871|143003220|SUPERIORITY_OR_OTHER||Least squares mean difference|0.016||||0.13|TWO_SIDED|90.0|-0.012|0.044||one-sided, alpha = 0.05|ANOVA|||||0.044|-0.012|0.130
71747187|NCT00871871|143003221|SUPERIORITY_OR_OTHER||Least squares mean difference|0.54|||>|0.5|TWO_SIDED|90.0|0.4|0.67|||ANCOVA|||||0.67|0.40|>0.500
71747188|NCT00871871|143003222|SUPERIORITY_OR_OTHER||Least squares mean difference|0.004||||0.342|TWO_SIDED|90.0|-0.023|0.014||one-sided, alpha = 0.05|ANOVA|||||0.014|-0.023|0.342
71747189|NCT00871871|143003223|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0016|||>|0.5|TWO_SIDED|90.0|-0.008|0.011|||ANOVA|||||0.011|-0.008|>0.500
71747190|NCT00871871|143003224|SUPERIORITY_OR_OTHER||Least squares mean difference|0.003|||>|0.5|TWO_SIDED|90.0|-0.003|0.01|||ANOVA|||||0.010|-0.003|>0.500
71666371|NCT03355469|142846958|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.187|TWO_SIDED|95.0|-0.031|0.007||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MFV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MFV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.007|-0.031|0.187
71666372|NCT03355469|142846959|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.086|TWO_SIDED|95.0|-0.495|0.035||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.008.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.035|-0.495|0.086
71747191|NCT01650194|143003236|OTHER|||||||0.615|||||||t-test, 2 sided|||Testosterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.6150
71747192|NCT01650194|143003238|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747193|NCT01650194|143003239|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747194|NCT01650194|143003240|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Progesterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747195|NCT01650194|143003241|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747196|NCT01650194|143003242|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Testosterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71779888|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.233||0.278|TWO_SIDED|95.0|-0.71|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||0.21|-0.71|0.278
71747197|NCT01650194|143003244|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Cortisol blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747198|NCT01650194|143003245|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747199|NCT01650194|143003246|OTHER|||||||0.0002|||||||t-test, 2 sided|||Progesterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||0.0002
71747200|NCT01650194|143003247|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.||||<.0001
71747201|NCT00880698|143003279|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.1||||0.62|TWO_SIDED|95.0|-20.6|14.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-uninfected participants experiencing a new grade \>=3 adverse event|||14.8|-20.6|0.62
71747202|NCT00880698|143003279|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.7||||1|TWO_SIDED|95.0|-21.0|23.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-infected participants experiencing a new grade \>=3 adverse event|||23.4|-21.0|1.00
71747203|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.9|||<|0.001|TWO_SIDED|95.0|11.5|46.1||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||46.1|11.5|<0.001
71747204|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|49.8|||<|0.001|TWO_SIDED|95.0|27.1|68.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1||68.6|27.1|<0.001
71747205|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.1||||0.2|TWO_SIDED|95.0|-11.3|24.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||24.8|-11.3|0.20
71779889|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.254||0.134|TWO_SIDED|95.0|-0.12|0.88|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.88|-0.12|0.134
71779890|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.254||0.397|TWO_SIDED|95.0|-0.29|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.72|-0.29|0.397
71779891|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.257||0.964|TWO_SIDED|95.0|-0.5|0.52|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||0.52|-0.50|0.964
71779892|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.269||0.155|TWO_SIDED|95.0|-0.15|0.91|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.91|-0.15|0.155
71666373|NCT03355469|142846959|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.608|TWO_SIDED|95.0|-0.354|0.574||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.050.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.574|-0.354|0.608
71834986|NCT05450458|143174568|OTHER|This study assessed longitudinal effects within a single patient group. Statistical power was calculated using a significance level of 0.05, 80% power, and 60 patients, accounting for IKDC score variability over time. The Friedman test was applied with post hoc analyses (Conover and Bonferroni). Since treatments were not compared, no non-inferiority or equivalence margin was defined|Median Baseline to Month 6|0.18||||0.01|TWO_SIDED|95.0|0.12|0.24||P-values were adjusted for multiple comparisons using the Bonferroni method, and the a priori threshold for statistical significance was set at 0.05.|Friedman Test|The overall p-value is unadjusted. The a priori significance level was set at 0.05 to robustly control the Type I error|This value represents the intra-individual median IKDC improvement from baseline to 6 months after treatment. The analysis was conducted within a single cohort without comparator arms.|The statistical analysis will use the Friedman test, as the Shapiro-Wilk test confirmed a non-normal distribution. Conover's post hoc test with Bonferroni correction will adjust for multiple comparisons. The null hypothesis states that hyaluronic acid injections with sorbitol do not significantly improve IKDC function and pain scores over time. A power analysis was performed to ensure an adequate sample size for detecting clinically meaningful differences.||0.24|0.12|0.01
71845277|NCT05886777|143204390|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 2,3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.632|1.125|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.125|0.632|
71747206|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2||||0.19|TWO_SIDED|95.0|-10.6|36.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2||36.7|-10.6|0.19
71747207|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|19.3|||<|0.001|TWO_SIDED|95.0|0.9|36.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||36.4|0.9|<0.001
71747208|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|29.4|||<|0.001|TWO_SIDED|95.0|4.7|50.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3||50.6|4.7|<0.001
71747209|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|8.0|42.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||42.9|8.0|<0.001
71747210|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|58.6|||<|0.001|TWO_SIDED|95.0|37.2|75.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4||75.9|37.2|<0.001
71747211|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4||||0.024|TWO_SIDED|95.0|-1.7|34.2||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||34.2|-1.7|0.024
71747212|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.7||||0.34|TWO_SIDED|95.0|-12.0|35.5||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1||35.5|-12.0|0.34
71747213|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|51.4|||<|0.001|TWO_SIDED|95.0|34.3|66.3||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||66.3|34.3|<0.001
71747214|NCT00880698|143003280|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|65.1|||<|0.001|TWO_SIDED|95.0|42.7|81.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA||81.7|42.7|<0.001
71747215|NCT00851786|143003289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.45|0.69||The p-value was adjusted for baseline gpELISA titer, measurement time (week 6 vs. week 12), CD4 stratum and age.|Linear mixed effect model|Natural log transformed gpELISA titers after one or two doses of vaccine was modeled.||Null hypothesis: VZV antibody titer measured by gpELISA, after 1 or 2 doses of ZOSTAVAX/placebo is the same between ZOSTAVAX arm and the placebo arm||0.69|0.45|<.001
71747216|NCT04290039|143003291|OTHER|Estimation only|Geometric ratio of least-square means|0.579|||||TWO_SIDED|90.0|0.5265|0.636|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6360|0.5265|
71666374|NCT03355469|142846959|SUPERIORITY||Mean Difference (Final Values)|-0.344||||0.11|TWO_SIDED|95.0|-0.779|0.09||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.017.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.090|-0.779|0.110
71666375|NCT03355469|142846959|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.145|TWO_SIDED|95.0|-0.818|0.137||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.033.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.137|-0.818|0.145
71666376|NCT03355469|142846959|SUPERIORITY||Mean Difference (Final Values)|-0.114||||0.565|TWO_SIDED|95.0|-0.538|0.309||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.042.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.309|-0.538|0.565
71747217|NCT04290039|143003291|OTHER|Estimation only|Geometric ratio of least-square means|0.349|||||TWO_SIDED|90.0|0.3171|0.3839|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3839|0.3171|
71747218|NCT04290039|143003291|OTHER|Estimation only|Geometric ratio of least-square means|0.603|||||TWO_SIDED|90.0|0.5524|0.6582|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6582|0.5524|
71891316|NCT04696861|143304373|SUPERIORITY|||||||0.207||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.207
71747219|NCT04290039|143003292|OTHER|Estimation only|Geometric ratio of least-square means|0.546|||||TWO_SIDED|90.0|0.4971|0.6004|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6004|0.4971|
71747220|NCT04290039|143003292|OTHER|Estimation only|Geometric ratio of least-square means|0.306|||||TWO_SIDED|90.0|0.2788|0.3367|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.3367|0.2788|
71747221|NCT04290039|143003292|OTHER|Estimation only|Geometric ratio of least-square means|0.561|||||TWO_SIDED|90.0|0.5104|0.6164|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.6164|0.5104|
71747222|NCT04290039|143003293|OTHER|Estimation only|Geometric ratio of least-square means|0.549|||||TWO_SIDED|90.0|0.4273|0.7118|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.7118|0.4273|
71747223|NCT04290039|143003293|OTHER|Estimation only|Geometric ratio of least-square means|0.049|||||TWO_SIDED|90.0|0.0381|0.0641|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.0641|0.0381|
71747224|NCT04290039|143003293|OTHER|Estimation only|Geometric ratio of least-square means|0.09|||||TWO_SIDED|90.0|0.0695|0.1167|||Mixed Models Analysis||Only subjects who had at least 2 periods where study drug was received with an evaluable PK profile were included in the comparisons.|||0.1167|0.0695|
71747225|NCT04233801|143003347|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed model repeated measures|||||-0.71|-1.28|< 0.0001
71747226|NCT04233801|143003347|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.7|||Mixed model repeated measures|||||-0.70|-1.26|< 0.0001
71747227|NCT04233801|143003348|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|2.29||||0.1375|TWO_SIDED|95.0|0.77|6.83|||Regression, Logistic|||||6.83|0.77|0.1375
71747228|NCT04233801|143003348|OTHER|Logistic regression including treatment, baseline Estimated glomerular filtration rate (eGFR), background therapy, and continuous baseline HbA1c.|Odds Ratio (OR)|6.01||||0.0008|TWO_SIDED|95.0|2.11|17.1|||Regression, Logistic|||||17.10|2.11|0.0008
71747229|NCT04233801|143003349|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.34|||Mixed model repeated measures|||||-1.34|-2.66|< 0.0001
71747230|NCT04233801|143003349|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.32|||<|0.0001|TWO_SIDED|95.0|-1.96|-0.67|||Mixed model repeated measures|||||-0.67|-1.96|< 0.0001
71747231|NCT04233801|143003350|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-3.6||||0.0774|TWO_SIDED|95.0|-7.61|0.4|||Mixed model repeated measures|||||0.40|-7.61|0.0774
71747232|NCT04233801|143003350|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.01||||0.616|TWO_SIDED|95.0|-4.98|2.96|||Mixed model repeated measures|||||2.96|-4.98|0.6160
71747233|NCT04233801|143003351|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-1.78||||0.1222|TWO_SIDED|95.0|-4.05|0.48|||Mixed model repeated measures|||||0.48|-4.05|0.1222
71834987|NCT05450458|143174570|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month IKDC score|Baseline to month 6|0.18||||0.001|TWO_SIDED|95.0|0.14|0.21||P-values from pairwise comparisons were adjusted using the Bonferroni method to control for multiple testing. The global p-value from the Friedman test was not adjusted. An a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median IKDC improvement from baseline to 6 months in 22 athletes with elevated BMI (≥25). No comparator group was used. Confidence interval calculated via bootstrap (resampling with 1,000 iterations).|The analysis was conducted under the null hypothesis of no change in knee function across time. Data normality was assessed using the Shapiro-Wilk test. Changes across the four time points (baseline, 15 days, 3 months, and 6 months) were evaluated using the Friedman test. Pairwise comparisons were performed post hoc using the Wilcoxon Signed-Rank Test with Bonferroni correction at a 5% significance threshold.||0.21|0.14|0.001
71845278|NCT05886777|143204391|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.42|||||TWO_SIDED|97.5|1.123|1.801|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.801|1.123|
71891317|NCT04696861|143304374|SUPERIORITY|||||||0.594||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.594
71747234|NCT04233801|143003351|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|0.65||||0.5687|TWO_SIDED|95.0|-1.59|2.89|||Mixed model repeated measures|||||2.89|-1.59|0.5687
71747235|NCT04233801|143003352|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-20.05||||0.0003|TWO_SIDED|95.0|-30.73|-9.38|||Mixed model repeated measures|||||-9.38|-30.73|0.0003
71747236|NCT04233801|143003352|OTHER|"A restricted maximum likelihood (REML) based mixed model repeated measures (MMRM) approach was applied.The model included baseline value for the corresponding endpoint and its interaction with visit as additional covariates."|Adjusted mean|-24.13|||<|0.0001|TWO_SIDED|95.0|-34.72|-13.54|||Mixed model repeated measures|||||-13.54|-34.72|<0.0001
71747237|NCT04233801|143003353|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-56.32|||<|0.0001|TWO_SIDED|95.0|-78.22|-34.41|||ANCOVA|||||-34.41|-78.22|<0.0001
71747238|NCT04233801|143003353|OTHER|The Analysis of covariance (ANCOVA) model included treatment and background therapy as classification effects, baseline PPG and baseline Estimated glomerular filtration rate (eGFR) as the linear covariates.|Adjusted mean|-60.71|||<|0.0001|TWO_SIDED|95.0|-82.31|-39.11|||ANCOVA|||||-39.11|-82.31|<0.0001
71747239|NCT04233801|143003354|OTHER||Odds Ratio (OR)|1.76||||0.2422|TWO_SIDED|95.0|0.68|4.55|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||4.55|0.68|0.2422
71747240|NCT04233801|143003354|OTHER||Odds Ratio (OR)|0.85||||0.7661|TWO_SIDED|95.0|0.29|2.5|||Regression, Logistic|Logistic regression including treatment and continuous baseline glycosylated haemoglobin A1c (HbA1c).|Odds ratio used Placebo as the reference group.|||2.50|0.29|0.7661
71747241|NCT01690052|143003368|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The p-value is calculated from the ANOVA||||||0.05
71747242|NCT02421172|143003370|SUPERIORITY_OR_OTHER_LEGACY||Posterior probablility|0.9729||||||||||||||||||
71747243|NCT00683878|143003376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1175||0.0007|TWO_SIDED|95.0|-0.63|-0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.17|-0.63|0.0007
71747244|NCT00683878|143003376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.1175|<|0.0001|TWO_SIDED|95.0|-0.78|-0.31||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment|ANCOVA|||||-0.31|-0.78|<0.0001
71747245|NCT00683878|143003377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.0|STANDARD_ERROR_OF_MEAN|9.007|<|0.0001|TWO_SIDED|95.0|-68.7|-33.2||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-33.2|-68.7|<0.0001
71747246|NCT00683878|143003377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.3|STANDARD_ERROR_OF_MEAN|9.039|<|0.0001|TWO_SIDED|95.0|-71.1|-35.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-35.6|-71.1|<0.0001
71747247|NCT00683878|143003378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.32|-0.79||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.79|-2.32|<0.0001
71747248|NCT00683878|143003378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.3896|<|0.0001|TWO_SIDED|95.0|-2.55|-1.02||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-1.02|-2.55|<0.0001
71747249|NCT00683878|143003379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|4.088|<|0.0001|TWO_SIDED|95.0|-27.5|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-11.4|-27.5|<0.0001
71747250|NCT00683878|143003379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|4.082|<|0.0001|TWO_SIDED|95.0|-32.2|-16.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-16.1|-32.2|<0.0001
71747251|NCT00683878|143003380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|5.119||0.0496|TWO_SIDED|95.0|0.0|20.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||20.1|0.0|0.0496
71747252|NCT00683878|143003380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.253||0.0018|TWO_SIDED|95.0|6.1|26.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression|||||26.7|6.1|0.0018
71747253|NCT00683878|143003381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.6006||0.1566|TWO_SIDED|95.0|-2.03|0.33||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||0.33|-2.03|0.1566
71747254|NCT00683878|143003381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.5995||0.0101|TWO_SIDED|95.0|-2.73|-0.37||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.37|-2.73|0.0101
71747255|NCT00683878|143003382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.4838|||TWO_SIDED|95.0|-2.53|-0.62||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. The comparison was stopped due to the preceding test (PLACEBO + Pio vs Dapa 5MG + Pio) not statistically significant P value = 0.1566.|ANCOVA|||||-0.62|-2.53|
71779893|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.269||0.491|TWO_SIDED|95.0|-0.34|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.72|-0.34|0.491
71779894|NCT01786668|143059381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.271||0.515|TWO_SIDED|95.0|-0.71|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||0.36|-0.71|0.515
71779895|NCT01786668|143059382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|1.312||0.006|TWO_SIDED|95.0|1.06|6.24|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.24|1.06|0.006
71779896|NCT01786668|143059382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|1.305||0.004|TWO_SIDED|95.0|1.23|6.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.37|1.23|0.004
71779897|NCT01786668|143059382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|1.74|6.98|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score||6.98|1.74|0.001
71779898|NCT01786668|143059382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.857||0.857|TWO_SIDED|95.0|-4.0|3.33|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||3.33|-4.00|0.857
71779899|NCT01786668|143059382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|1.848||0.35|TWO_SIDED|95.0|-1.91|5.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.37|-1.91|0.350
71779900|NCT01786668|143059382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.876||0.49|TWO_SIDED|95.0|-2.4|5.0|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score||5.00|-2.40|0.490
71779901|NCT01786668|143059383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.048||0.125|TWO_SIDED|95.0|-0.02|0.17|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.17|-0.02|0.125
71779902|NCT01786668|143059383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.048||0.207|TWO_SIDED|95.0|-0.03|0.16|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.16|-0.03|0.207
71779903|NCT01786668|143059383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.049||0.013|TWO_SIDED|95.0|0.03|0.22|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||||0.22|0.03|0.013
71747256|NCT00683878|143003382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.4688|<|0.0001|TWO_SIDED|95.0|-2.83|-0.98||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA|||||-0.98|-2.83|<0.0001
71747257|NCT00599872|143003392|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.418|||<|0.05|TWO_SIDED|95.0|-1.15|0.48|||ANCOVA|||||0.48|-1.15|<0.05
71747258|NCT00599872|143003393|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|||<|0.05|TWO_SIDED|95.0|-1.72|0.63|||ANCOVA|||||0.63|-1.72|<0.05
71747259|NCT01693029|143003403|EQUIVALENCE|"Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors treatment group and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)"|Mean Difference (Final Values)|-0.0926|||||TWO_SIDED|90.0|-0.2264|0.0413|||||||95% confidence interval for the difference is (-0.2522, 0.0670).|0.0413|-0.2264|
71747260|NCT03489863|143003456|NON_INFERIORITY|see above|Mean Difference (Net)|-18.0|||<|0.05|TWO_SIDED|95.0|-38.0|2.0|||ANCOVA|||The primary endpoint is non-inferiority in PRU, at 24 hours of prasugrel versus ticagrelor. Under the assumption of 0 difference at 24 hours in mean PRU between ticagrelor and prasugrel and a common standard deviation of 50 PRU, a sample size of 22 patients per group allows for the 95% CI to stay within ± 45 PRU with a 90% power and alpha = 0.05.||2|-38|<0.05
71747261|NCT01173016|143003477|OTHER|||||||0.038|||||||Regression, Logistic|||Impact of anti-laronidase antibody status on the change in 6MWT outcome was tested||||0.038
71747262|NCT00657540|143003478|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|The proportion of treatment failures was compared between groups using a one-sided test at the 0.025 level of significance.||||||0.0185
71747263|NCT00657540|143003479|SUPERIORITY_OR_OTHER|||||||0.2302|||||||Chi-squared|Chi-squared tests at the 0.025 level of significance were used to test for a difference in proportions between the treatment groups.||||||0.2302
71747264|NCT00657540|143003480|SUPERIORITY_OR_OTHER|||||||0.8213|||||||Chi-squared|The proportion of subjects with at least one drug-related adverse event by treatment groups using a two-sided test at the 0.05 level of significance.||||||0.8213
71891318|NCT04696861|143304375|SUPERIORITY|||||||0.738||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.738
71747265|NCT00657540|143003481|SUPERIORITY_OR_OTHER|||||||0.2765|||||||Chi-squared|The proportion of subjects with decreased pain at any time point between treatment groups using a one-sided test at the 0.025 level of significance.||||||0.2765
71747266|NCT01169103|143003485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||95.0|||||t-test, 2 sided|||We assumed that mean decrease in visceral fat in our population would be 0.85\*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.||||0.70
71747267|NCT01169103|143003485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||t-test, 2 sided|||Change in SAT p-value||||0.30
71747268|NCT01169103|143003486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.93
71747269|NCT01169103|143003487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||t-test, 2 sided|||Change in Total Cholesterol p-value||||0.03
71747270|NCT01169103|143003487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Change in Triglyceride p-value||||0.57
71747271|NCT01169103|143003487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||t-test, 2 sided|||Change in Low-density lipoprotein p-value||||0.062
71747272|NCT01169103|143003487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||t-test, 2 sided|||Change in High-density lipoprotein p-value||||0.0396
71747273|NCT01169103|143003488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 2 sided|||||||0.58
71747274|NCT01169103|143003489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
71747275|NCT02656017|143003493|SUPERIORITY||Mean Difference (Net)|0.07||||0.5|TWO_SIDED|95.0|-0.13|0.26|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GSRS score as a function of time, the interaction between time and study arm, and clinical site.||0.26|-0.13|0.50
71747276|NCT02656017|143003494|SUPERIORITY|||||||0.12|||||||Gray's test|||The Gray's test of homogeneity for competing risks was used to compare cumulative incidence of tolerating the drug between study arms.||||0.12
71747277|NCT02656017|143003495|SUPERIORITY|||||||0.98|||||||Regression, Logistic|||Cumulative incidence between study arms and logistic regression was used to assess the association between study arms.||||0.98
71747278|NCT02656017|143003496|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.72|TWO_SIDED|95.0|-1.81|2.6|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 PCS as a function of time, the interaction between time and study arm, and clinical site.||2.60|-1.81|0.72
71747279|NCT02656017|143003497|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.49|TWO_SIDED|95.0|-2.02|4.25|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in SF-36 MCS as a function of time, the interaction between time and study arm, and clinical site.||4.25|-2.02|0.49
71747280|NCT02656017|143003498|SUPERIORITY|||||||0.44|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare back pain frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.44
71747281|NCT02656017|143003499|SUPERIORITY||Mean Difference (Final Values)|2.73||||0.2|TWO_SIDED|95.0|-1.4|6.87|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in eGFR as a function of time, the interaction between time and study arm, and clinical site.||6.87|-1.40|0.20
71747282|NCT02656017|143003500|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.38|TWO_SIDED|95.0|-2.11|5.62|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKV) as a function of time, the interaction between time and study arm, and clinical site.||5.62|-2.11|0.38
71747283|NCT02656017|143003501|SUPERIORITY||Mean Difference (Final Values)|3.81||||0.31|TWO_SIDED|95.0|-3.48|11.65|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htTKCV) as a function of time, the interaction between time and study arm, and clinical site.||11.65|-3.48|0.31
71747284|NCT02656017|143003502|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.72|TWO_SIDED|95.0|-1.78|2.61|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLV) as a function of time, the interaction between time and study arm, and clinical site.||2.61|-1.78|0.72
71779904|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|1.232||0.163|TWO_SIDED|95.0|-0.71|4.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||4.15|-0.71|0.163
71779905|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.232||0.955|TWO_SIDED|95.0|-2.36|2.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.50|-2.36|0.955
71779906|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.237||0.826|TWO_SIDED|95.0|-2.17|2.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2||2.71|-2.17|0.826
71779907|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|1.322||0.246|TWO_SIDED|95.0|-1.07|4.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||4.14|-1.07|0.246
71779908|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.318||0.467|TWO_SIDED|95.0|-1.64|3.56|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||3.56|-1.64|0.467
71747285|NCT02656017|143003503|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.8|TWO_SIDED|95.0|-10.05|14.76|||Mixed Models Analysis|||Linear mixed model with random intercept and slope was used to compare the annual percent change of ln(htLCV) as a function of time, the interaction between time and study arm, and clinical site.||14.76|-10.05|0.80
71747286|NCT02656017|143003504|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare abdominal fullness interfered as a function of time, the interaction between time and study arm, and clinical site.||||0.83
71747287|NCT02656017|143003505|SUPERIORITY|||||||0.72|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with sleep frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.72
71747288|NCT02656017|143003506|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept and slope was used to compare interference of pain with strenuous physical activity frequency as a function of time, the interaction between time and study arm, and clinical site.||||0.28
71747289|NCT04755816|143003507|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
71747290|NCT04755816|143003508|OTHER|Estimates and confidence intervals are provided|Win Ratio|1.29|||||TWO_SIDED|95.0|1.08|1.54||||||"Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in group A and B. By the unmatched pairs win ratio method, each participant receiving the intervention will be compared to each participant not receiving the intervention. For each comparison, winners will be determined according to the hierarchy described above. The win ratio is the number winners divided by the number of losers associated with the intervention."||1.54|1.08|
71747291|NCT04755816|143003510|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.321|3.743||||||Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C.||3.743|0.321|
71747292|NCT04755816|143003511|OTHER|Estimates and confidence intervals are provided|Slope|-15.37|||||TWO_SIDED|95.0|-37.5|6.76|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Dietary Sodium Intervention includes those in treatment group B and D. No Dietary Sodium Intervention includes those in treatment group A and C. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||6.76|-37.5|
71747293|NCT04755816|143003512|OTHER|Estimates and confidence intervals are provided|Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.163|1.901||||||Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B.||1.901|0.163|
71747294|NCT04755816|143003513|OTHER|Estimates and confidence intervals are provided|Slope|-12.98|||||TWO_SIDED|95.0|-33.67|7.72|||||"The total score for the MLHFQ ranges from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. The change in MLHFQ is defined as MLHFQ at Week 12 minus MLHFQ at Week 0."|Clinical Worsening Intervention includes those in treatment group C and D. No Clinical Worsening Intervention includes those in treatment group A and B. Simple linear regression models will be used to assess the outcome of change in MLHFQ over 12 weeks as a function of treatment group assignment. Beta coefficients and 95% confidence intervals will be reported.||7.72|-33.67|
71747295|NCT02792231|143003514|SUPERIORITY||rate ratio|0.416|||<|0.001|TWO_SIDED|95.0|0.309|0.56|||negative binomial regression model|||Obtained from fitting a negative binomial regression model with log-link to the number of relapses, adjusted for treatment and region as factors, number of relapses in previous year, baseline EDSS, baseline number of Gd-enhancing lesions and the patient's age at baseline as covariates. The natural log of the time-in-study was used as offset to annualize the relapse rate.||0.560|0.309|<0.001
71747296|NCT02792231|143003515|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.003|TWO_SIDED|95.0|0.5|0.863|||Regression, Cox|||Pooled data - this study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.863|0.500|0.003
71747297|NCT02792231|143003516|SUPERIORITY||Hazard Ratio (HR)|0.662||||0.038|TWO_SIDED|95.0|0.449|0.977|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.977|0.449|0.038
71747298|NCT02792231|143003517|SUPERIORITY||Hazard Ratio (HR)|0.676||||0.012|TWO_SIDED|95.0|0.498|0.917|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.917|0.498|0.012
71747299|NCT02792231|143003518|SUPERIORITY||Hazard Ratio (HR)|0.759||||0.215|TWO_SIDED|95.0|0.49|1.174|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.174|0.490|0.215
71747300|NCT02792231|143003519|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.092|TWO_SIDED|95.0|0.952|1.928|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||1.928|0.952|0.092
71747301|NCT02792231|143003520|SUPERIORITY||Hazard Ratio (HR)|1.523||||0.09|TWO_SIDED|95.0|0.936|2.477|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||2.477|0.936|0.090
71891319|NCT04696861|143304376|SUPERIORITY|||||||0.845||||||Unitized unadjusted bivariate analyses instead of adjusted multivariable analysis. This was a pilot study to estimate the magnitude of effect sizes for informing further large interventions. The significance level was also not adjusted.|Mixed Models Analysis|||General linear mixed models||||0.845
71666377|NCT03355469|142846959|SUPERIORITY||Mean Difference (Final Values)|-0.454||||0.11|TWO_SIDED|95.0|-1.025|0.116||Benjamini and Hochberg method was used to decrease the false discovery rate with an overall error rate of 0.05. The B\&H P-value threshold for this comparison was 0.025.|ANCOVA|ANCOVA linear model adjusted for pre-intervention MBV.||Intention to treat Full Maximum Likelihood based comparisons of baseline covariate adjusted pre- to post-intervention MBV change, where the difference is between treatment combination #2 and treatment combination #1 (i.e. treatment combination # 2 - treatment combination #1).||0.116|-1.025|0.110
71666378|NCT01708941|142846960|SUPERIORITY|||||||0.49|||||||Log Rank|||The primary comparison was ipilimumab + HDI versus ipilimumab alone, across ipilimumab dose (Arms A \& C versus Arms B \& D)||||0.490
71747302|NCT02792231|143003521|SUPERIORITY||rate ratio|0.061|||<|0.001|TWO_SIDED|95.0|0.037|0.101|||negative binomial regression model|||||0.101|0.037|<.001
71747303|NCT02792231|143003522|SUPERIORITY||rate ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.17|0.27|||negative binomial regression model|||Month 12||0.27|0.17|<.001
71779909|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.328||0.948|TWO_SIDED|95.0|-2.53|2.7|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4||2.70|-2.53|0.948
71779910|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.479||0.255|TWO_SIDED|95.0|-1.23|4.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.61|-1.23|0.255
71779911|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|1.479||0.187|TWO_SIDED|95.0|-0.96|4.87|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.87|-0.96|0.187
71779912|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.497||0.373|TWO_SIDED|95.0|-1.62|4.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8||4.29|-1.62|0.373
71779913|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.643||0.313|TWO_SIDED|95.0|-1.58|4.9|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||4.90|-1.58|0.313
71779914|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|1.642||0.017|TWO_SIDED|95.0|0.71|7.19|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.19|0.71|0.017
71779915|NCT01786668|143059384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51|STANDARD_ERROR_OF_MEAN|1.66||0.007|TWO_SIDED|95.0|1.23|7.78|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12||7.78|1.23|0.007
71779916|NCT00762385|143059387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03164|STANDARD_ERROR_OF_MEAN|0.1247||||98.3|-0.2346|0.03164|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.03164|-0.2346|
71779917|NCT00762385|143059388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.00556|STANDARD_ERROR_OF_MEAN|0.02287||||98.3|-0.04297|0.00556|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.005560|-0.04297|
71779918|NCT00762385|143059389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2726|STANDARD_ERROR_OF_MEAN|0.1064||||98.3|0.04553|0.2726|||Mixed Models Analysis||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.||0.2726|0.04553|
71779919|NCT01776840|143059390|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.011|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||0.96|0.59|0.011
71779920|NCT03068455|143059414|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.04|0.78|
71779921|NCT03068455|143059415|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.75|1.14|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab|||1.14|0.75|
71779922|NCT03068455|143059416|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.8|1.32|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.32|0.80|
71779923|NCT03068455|143059417|SUPERIORITY||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.85|1.73|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.|||1.73|0.85|
71779924|NCT03068455|143059418|SUPERIORITY|\< 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.73|1.14|||||Unstratisfied HR, Nivolumab over Ipilimumab|||1.14|0.73|
71779925|NCT03068455|143059418|SUPERIORITY|\>= 1% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.18|0.76|
71666379|NCT01708941|142846961|SUPERIORITY|||||||0.144|||||||Log Rank|||PFS comparison of higher dose ipilimumab versus lower dose ipilimumab (Arms A \& B versus Arms C \& D)||||0.144
71666380|NCT01708941|142846962|SUPERIORITY|||||||0.691|||||||Log Rank|||||||0.691
71666381|NCT01708941|142846963|SUPERIORITY|||||||0.868|||||||Log Rank|||Comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A \& B versus Arms C \& D)||||0.868
71747304|NCT02792231|143003522|SUPERIORITY||rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.12|0.31|||negative binomial regression model|||Month 24||0.31|0.12|<.001
71747305|NCT02792231|143003522|SUPERIORITY||rate ratio|0.15|||<|0.001|TWO_SIDED|95.0|0.13|0.19|||negative binomial regression model|||End of Study||0.19|0.13|<.001
71747306|NCT02792231|143003523|SUPERIORITY||Geo-mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.85|0.93|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 3||0.93|0.85|<.001
71747307|NCT02792231|143003523|SUPERIORITY||Geo-mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.7|0.79|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 12||0.79|0.70|<.001
71779926|NCT03068455|143059418|SUPERIORITY|\>= 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.71|1.34|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.34|0.71|
71779927|NCT03068455|143059418|SUPERIORITY|\< 5% Tumor PD-L1 Expression|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.10|0.77|
71666382|NCT01575548|142846966|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.21|TWO_SIDED|95.0|0.54|1.29|||Log Rank|Stratified log rank test was used to compare DFS between the two arms.||||1.29|0.54|0.21
71666383|NCT03952585|142846981|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|7.42|||||ONE_SIDED|90.0||19.46|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||19.46||
71666384|NCT03952585|142846981|NON_INFERIORITY|Estimated 9-month PFS = 96.5% and lower acceptable threshold = 91.8%, resulting in a non-inferiority margin of 4.7%. H0: HR = 2.4; alternative hypothesis (HA): HR=1.0. One-sided type I error rate of 10% (20% after Bonferroni adjustment for each experimental arm comparison), 80% power, 24 months of accrual with 1 year of additional follow-up, and 1% increasing yearly rate of drop-out up to 3%, a log rank test requires 22 events from 266 patients per comparison resulting in 133 patients per arm.|Hazard Ratio (HR)|5.55|||||ONE_SIDED|90.0||14.85|||||Reference level = Arm 1|The null hypothesis (H0) for each comparison in phase II will be rejected if the 90% upper confidence of the hazard ratio (HR) (experimental arm / standard arm) is less than HR=2.4.||14.85||
71666385|NCT03952585|142846984|SUPERIORITY||Hazard Ratio (HR)|20.56|||||TWO_SIDED|95.0|1.05|403.31|||||Cause-specific; reference level = Arm 1|||403.31|1.05|
71666386|NCT03952585|142846984|SUPERIORITY||Hazard Ratio (HR)|12.87|||||TWO_SIDED|95.0|0.58|287.93|||||Reference level = Arm 1|||287.93|0.58|
71666387|NCT03952585|142846985|SUPERIORITY||Cox Proportional Hazard|1.78|||||TWO_SIDED|95.0|0.34|9.46|||||Cause-specific; reference level = Arm 1|||9.46|0.34|
71666388|NCT03952585|142846985|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.24|8.45|||||Cause-specific; reference level = Arm 1|||8.45|0.24|
71666389|NCT03952585|142846986|SUPERIORITY||Hazard Ratio (HR)|5.58|||||TWO_SIDED|95.0|0.67|46.41|||||Reference level = Arm 1|||46.41|0.67|
71666390|NCT03952585|142846986|SUPERIORITY||Hazard Ratio (HR)|4.87|||||TWO_SIDED|95.0|0.57|41.74|||||Reference level = Arm 1|||41.74|0.57|
71666391|NCT02048813|142846998|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.56|||Log Rank|||||0.56|0.22|<.001
71666392|NCT02048813|142846999|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.05|0.54|||Log Rank|||||0.54|0.05|<.001
71747308|NCT02792231|143003523|SUPERIORITY||Geo-mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.71|0.81|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||Month 24||0.81|0.71|<.001
71747309|NCT02792231|143003524|SUPERIORITY||Mean Difference (Net)|0.07||||0.128|TWO_SIDED|95.0|-0.02|0.15|||random coefficient model|||||0.15|-0.02|0.128
71666393|NCT01708954|142847010|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|80.0|0.25|0.53|||||Hazard ratio of Arm C/Arm A|||0.53|0.25|
71747310|NCT02792231|143003527|SUPERIORITY||Hazard Ratio (HR)|0.641||||0.002|TWO_SIDED|95.0|0.486|0.847|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.847|0.486|0.002
71747311|NCT02792231|143003528|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.008|TWO_SIDED|95.0|0.481|0.898|||Regression, Cox|||This study was not powered for the analysis of this endpoint individually. It was pre-specified in the study protocol to combine the data from this study with study COMB157G2301 to address this endpoint.||0.898|0.481|0.008
71666394|NCT01708954|142847010|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|80.0|0.27|0.55|||||Hazard ratio of Arm B/Arm A|||0.55|0.27|
71666395|NCT03631199|142847045|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.62||||0.00164|TWO_SIDED|95.0|0.45|0.86|||Log Rank|||Chest pain||0.86|0.45|0.00164
71666396|NCT03631199|142847045|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.59||||0.00069|TWO_SIDED|95.0|0.43|0.82|||Log Rank|||Cough||0.82|0.43|0.00069
71666397|NCT03631199|142847045|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.66||||0.00045|TWO_SIDED|95.0|0.51|0.84|||Log Rank|||Dyspnea||0.84|0.51|0.00045
71666398|NCT03631199|142847046|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.86||||0.113|TWO_SIDED|95.0|0.66|1.1|||Log Rank|||Quality of Life||1.10|0.66|0.113
71666399|NCT03631199|142847046|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.68||||0.00433|TWO_SIDED|95.0|0.51|0.91|||Log Rank|||Shortness of Breath||0.91|0.51|0.00433
71666400|NCT03631199|142847046|EQUIVALENCE|Nominal p-values are presented without any statistical inference since there was no adjustment for multiplicity.|Hazard Ratio (HR)|0.93||||0.294|TWO_SIDED|95.0|0.72|1.2|||Log Rank|||Pain||1.20|0.72|0.294
71666401|NCT03651700|142847067|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71666402|NCT03651700|142847068|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71666403|NCT05124691|142847069|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
71747312|NCT04073186|143003552|SUPERIORITY|The superiority of the First wearing Cycle was concluded if the lower confidence limit of leastsquare mean as greater than 32.|Least-square Mean|59.3|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|54.6|64.0|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.||||64.0|54.6|
71779928|NCT03068455|143059418|SUPERIORITY|Non-quantifiable Tumor PD-L1 Expression|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.38|1.51|||||Unstratisfied HR, Nivolumab over ipilimumab|||1.51|0.38|
71666404|NCT05124691|142847069|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
71666405|NCT05124691|142847069|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates within the three study groups, considering an overall significance level of 0.05. To account for multiple testing, a Bonferroni correction was applied, resulting in an adjusted significance level of 0.0167||||<0.0001
71747313|NCT04073186|143003553|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.10 logMAR.|Least-square Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.124|-0.044||Distance (4 Meter)|Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom.||||-0.044|-0.124|
71747314|NCT04073186|143003553|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR.|Least-square Mean|-0.028|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.068|0.012|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Intermediate (64 CM)||0.012|-0.068|
71747315|NCT04073186|143003553|SUPERIORITY|The superiority of the Test lens was concluded if the upper confidence limit of least-square mean was below the pre-defined threshold 0.17 logMAR|Least-square Means|0.037|STANDARD_ERROR_OF_MEAN|0.0191|||TWO_SIDED|95.0|-0.003|0.077|||Linear Mixed Model|The Kenward and Roger Method was used for the demoninator degrees of freedom||Near (40 CM)||0.077|-0.003|
71747316|NCT04073186|143003554|SUPERIORITY|The superiority of the Test lens at 4-week followup compared to it at 2-week follow-up will beconcluded if the lower confidence limit of leastsquare mean difference is greater than 0.|Least-square Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-8.1|-0.1|||Linear Mixed Model|the Kenward and Roger method was used for the denominator degrees of freedom.|LSM difference was calculated as Second Wearing Cycle minus First Wearing Cycle|||-0.1|-8.1|
71747317|NCT00558246|143003647|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|Differences in proportion of successes|0.0||||1|TWO_SIDED|95.0|-5.9|5.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||5.9|-5.9|1.0000
71747318|NCT00558246|143003648|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71747319|NCT00558246|143003649|SUPERIORITY_OR_OTHER|||||||1||95.0|||||McNemar|||||||1.0000
71747320|NCT00558246|143003650|SUPERIORITY_OR_OTHER|||||||0.2266|||||||McNemar|||||||0.2266
71747321|NCT00558246|143003651|SUPERIORITY_OR_OTHER|||||||0.5078||0.0|||||McNemar|||||||0.5078
71666406|NCT05124691|142847072|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||<0.0001
71747322|NCT05552027|143003656|SUPERIORITY||||||<|0.001||||||At the completion of scenario A (a full child safety seat installation), the participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.001
71747323|NCT05552027|143003656|SUPERIORITY||||||<|0.01||||||At the end of scenario B (loose harness straps), participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
71747324|NCT05552027|143003656|SUPERIORITY||||||<|0.01||||||At the end of scenario C (loose attachment at the base), like the other two scenarios, participants using the CCS app had significantly fewer errors present compared to the control group.|Chi-squared|||||||<.01
71747325|NCT04244253|143003663|SUPERIORITY||Difference of score|-1.1||||0.288|TWO_SIDED|95.0|-3.3|1.0|||Mixed-model repeated measures|MMRM included treatment, visit, treatment-by-visit interaction, baseline, and baseline-by-visit interaction using an unstructured covariance matrix.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||1.0|-3.3|0.288
71747326|NCT04244253|143003664|OTHER||Difference in response rate|5.6||||0.329|TWO_SIDED|95.0|-5.6|16.8|||χ2 test|The MADRS response rate in the OPC-64005 20-mg group and the placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||16.8|-5.6|0.329
71747327|NCT04244253|143003665|OTHER||Difference of Proportion|1.5||||0.731|TWO_SIDED|95.0|-7.2|10.3|||χ2 test|The MADRS remission rate in the OPC-64005 20-mg group and placebo group were compared using the χ2 test in the LOCF dataset.||The statistical analysis was performed at Week 6 to compare the OPC-64005 20-mg group and placebo group.||10.3|-7.2|0.731
71747328|NCT04663321|143003666|SUPERIORITY|Difference in LS Means|LS Mean Difference|3.3||||0.168|TWO_SIDED|95.0|-1.4|8.0|||ANCOVA|||||8.0|-1.4|0.168
71747329|NCT04663321|143003666|SUPERIORITY|Difference in LS Means|LS Mean Difference|-1.1||||0.697|TWO_SIDED|95.0|-6.9|4.7|||ANCOVA|||||4.7|-6.9|0.697
71891320|NCT02382133|143304378|SUPERIORITY|comparing nasal and forehead oximetry sensor pressure ulcer incidence|||||=|0.006|||||||Chi-squared|||||||=.006
71666407|NCT05124691|142847072|SUPERIORITY||||||=|0.0007|||||||Cochran-Mantel-Haenszel|||Pairwise comparisons of cure rates were conducted between Albendazole and FDCx3, as well as FDCx1 and FDCx3, but not between Albendazole and FDCx1, since both contain the same dose regimen of the active drug. An overall significance level of 0.05 was considered, and to account for multiple testing, a Bonferroni correction was applied.||||=0.0007
71747330|NCT04663321|143003667|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.9||||0.124|TWO_SIDED|95.0|-0.8|6.6|||ANCOVA|||||6.6|-0.8|0.124
71747331|NCT04663321|143003667|SUPERIORITY|Difference in LS Means|LS Mean Difference|1.9||||0.417|TWO_SIDED|95.0|-2.7|6.4|||ANCOVA|||||6.4|-2.7|0.417
71747332|NCT04663321|143003670|SUPERIORITY|Difference in LS Means|LS Mean Difference|2.0||||0.187|TWO_SIDED|95.0|-1.0|5.1|||ANCOVA|||||5.1|-1.0|0.187
71747333|NCT04663321|143003670|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.6||||0.738|TWO_SIDED|95.0|-4.3|3.1|||ANCOVA|||||3.1|-4.3|0.738
71747334|NCT04663321|143003671|SUPERIORITY|Difference in LS means|LS Mean Difference|1.7||||0.182|TWO_SIDED|95.0|-0.8|4.3|||ANCOVA|||||4.3|-0.8|0.182
71747335|NCT04663321|143003672|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.1||||0.63|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.630
71747336|NCT04663321|143003672|SUPERIORITY|Difference in LS Means|LS Mean Difference|-0.2||||0.549|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.549
71891321|NCT01976806|143304408|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|||||||Mixed Models Analysis|Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables|Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths \>=5 mm in the DHA intervention group versus the placebo group.|Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.||||<0.05
71891322|NCT03896581|143304476|SUPERIORITY||Odds Ratio (OR)|11.139|||<|0.001|TWO_SIDED|95.0|5.402|22.969|||Regression, Logistic|||||22.969|5.402|<0.001
71891323|NCT03896581|143304477|SUPERIORITY||Least square (LS) mean difference|-0.326|||<|0.001|TWO_SIDED|95.0|-0.42|-0.233|||ANCOVA|||||-0.233|-0.420|<0.001
71666408|NCT05124691|142847075|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71747337|NCT04663321|143003673|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.4||||0.062|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||||0.8|-0.0|0.062
71747338|NCT04663321|143003673|SUPERIORITY|Difference in LS Means|LS Mean Difference|0.0||||0.878|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||||0.5|-0.5|0.878
71747339|NCT00423657|143003682|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than -10%.|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.8|5.0|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.||5.0|-5.8|
71747340|NCT02795117|143003690|EQUIVALENCE|provides 85% power of success|equivalence ratio|96.4|||||TWO_SIDED|90.0|91.0|105.4||No p-value was calculated for bioequivalence, only a T/R ratio and 90% confidence interval|ANOVA|||||105.4|91.0|
71747341|NCT02795117|143003691|EQUIVALENCE|provides 85% power of success|Equivalence difference|-6.48|||||TWO_SIDED|90.0|-18.31|1.85|||Wald's method|||||1.85|-18.31|
71891324|NCT03896581|143304479|SUPERIORITY||Odds Ratio (OR)|30.237|||<|0.001|TWO_SIDED|95.0|12.365|73.94|||Regression, Logistic|||||73.940|12.365|<0.001
71891325|NCT03896581|143304480|SUPERIORITY||LS mean difference|6.037|||<|0.001|TWO_SIDED|95.0|4.386|7.688|||ANCOVA|||||7.688|4.386|<0.001
71891326|NCT03896581|143304481|SUPERIORITY||Odds Ratio (OR)|13.089|||<|0.001|TWO_SIDED|95.0|6.119|27.999|||Regression, Logistic|||||27.999|6.119|<0.001
71666409|NCT05124691|142847075|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71666410|NCT05124691|142847075|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71747342|NCT02653326|143003693|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71747343|NCT02653326|143003694|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
71747344|NCT04621448|143003702|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.048|TWO_SIDED|95.0|0.01|4.39|||Mixed Models Analysis||The mean difference estimate of 2.2 was confirmed. It is slightly different than the difference of the raw change values \[+.7 - (-1.7) = 2.4\] because it comes from the mixed effects model.|||4.39|0.01|0.048
71747345|NCT04621448|143003703|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.603|TWO_SIDED|95.0|-4.12|2.4|||Mixed Models Analysis|||||2.40|-4.12|0.603
71747346|NCT04621448|143003704|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.734|TWO_SIDED|95.0|-2.75|3.92|||Mixed Models Analysis|||||3.92|-2.75|0.734
71666411|NCT04345913|142847214|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.5259|||||||Log Rank|||||||0.5259
71666412|NCT04345913|142847219|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.706|||||||Log Rank|||||||0.7060
71747347|NCT04621448|143003705|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.159|TWO_SIDED|95.0|-0.62|3.74|||Mixed Models Analysis|||||3.74|-0.62|0.159
71747348|NCT04621448|143003706|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.818|TWO_SIDED|95.0|-1.97|1.56|||Mixed Models Analysis|||||1.56|-1.97|0.818
71747349|NCT04621448|143003707|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.089|TWO_SIDED|95.0|-0.26|3.51|||Mixed Models Analysis|||||3.51|-0.26|0.089
71747350|NCT04621448|143003708|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.631|TWO_SIDED|95.0|-0.96|1.58|||Mixed Models Analysis|||||1.58|-0.96|0.631
71747351|NCT04621448|143003709|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.484|TWO_SIDED|95.0|-0.71|1.49|||Mixed Models Analysis|||||1.49|-0.71|0.484
71747352|NCT04621448|143003710|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.81|TWO_SIDED|95.0|-2.36|3.01|||Mixed Models Analysis|||||3.01|-2.36|0.81
71747353|NCT04621448|143003711|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.384|TWO_SIDED|95.0|-0.77|2.0|||Mixed Models Analysis|||||2.00|-0.77|0.384
71747354|NCT04621448|143003712|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.509|TWO_SIDED|95.0|-1.65|0.81|||Mixed Models Analysis|||||0.81|-1.65|0.509
71747355|NCT04621448|143003713|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.021|TWO_SIDED|95.0|0.24|3.01|||Mixed Models Analysis|||||3.01|0.24|0.021
71747356|NCT04621448|143003714|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.156|TWO_SIDED|95.0|-1.94|0.31|||Mixed Models Analysis|||||0.31|-1.94|0.156
71747357|NCT04621448|143003715|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.582|TWO_SIDED|95.0|-0.62|1.1|||Mixed Models Analysis|||||1.10|-0.62|0.582
71891327|NCT03797001|143304501|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
71891328|NCT00960076|143304541|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.108|||TWO_SIDED|95.0|-0.73|-0.31||||||||-0.31|-0.73|
71891329|NCT00960076|143304542|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.32|STANDARD_ERROR_OF_MEAN|7.128|||TWO_SIDED|95.0|-37.36|-9.28||||||||-9.28|-37.36|
71891330|NCT00960076|143304543|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|STANDARD_ERROR_OF_MEAN|4.409|||TWO_SIDED|95.0|-21.86|-4.5||||||||-4.50|-21.86|
71891331|NCT00960076|143304544|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.2||||0.0459|TWO_SIDED|95.0|0.2|22.0|||ANCOVA|||||22.0|0.2|0.0459
71666413|NCT00490841|142847271|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||1-sided exact binomial test|||"objective is to demonstrate the binary restenosis rate at 9 months is \< 28.6% OPC. Assumptions for the primary endpoint analysis:~* H0: Restenosis Rate ≥ 28.6%~* HA: Restenosis Rate \< 28.6%~* Assumed binary restenosis rate = 20%~* Power = 80%~* One-sided type I error = 5%~With the above assumptions, 161 samples would be required. To account for approximately 20% lost to follow-up rate, 202 subjects will be enrolled in the study. The sample size calculation was performed using PASS 2005."||||< 0.0001
71747358|NCT04621448|143003716|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.271|TWO_SIDED|95.0|-1.21|0.34|||Mixed Models Analysis|||||0.34|-1.21|0.271
71747359|NCT04621448|143003717|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.834|TWO_SIDED|95.0|-1.52|1.88|||Mixed Models Analysis|||||1.88|-1.52|0.834
71747360|NCT04621448|143003718|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.529|TWO_SIDED|95.0|-1.62|3.15|||Mixed Models Analysis|||||3.15|-1.62|0.529
71747361|NCT04621448|143003719|SUPERIORITY|||||||0.377|||||||Poisson regression|||||||0.377
71747362|NCT04621448|143003720|SUPERIORITY|||||||0.043|||||||Poisson regression|||||||0.043
71747363|NCT01506271|143003741|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|1.1|||<|0.001|TWO_SIDED|95.0|-6.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|MK-7655 250 mg - Placebo: Percentage Difference||8.6|-6.2|< 0.001
71747364|NCT01506271|143003741|NON_INFERIORITY|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|3.7|||<|0.001|TWO_SIDED|95.0|-2.0|10.8|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.8|-2.0|< 0.001
71747365|NCT01506271|143003742|OTHER|Test for a non-zero difference.|Percentage Difference|0.0||||0.979|TWO_SIDED|95.0|-4.7|4.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.5|-4.7|0.979
71747366|NCT01506271|143003742|OTHER|Test for a non-zero difference.|Percentage Difference|-1.8||||0.153|TWO_SIDED|95.0|-6.2|1.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||1.5|-6.2|0.153
71747367|NCT01506271|143003743|OTHER|Test for a non-zero difference.|Percentage Difference|0.9||||0.324|TWO_SIDED|95.0|-2.4|4.7|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||4.7|-2.4|0.324
71747368|NCT01506271|143003743|OTHER|Test for a non-zero difference|Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.3|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||3.2|-3.3|> 0.999
71747369|NCT01506271|143003744|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|7.5|||||TWO_SIDED|95.0|-5.4|20.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||20.1|-5.4|
71747370|NCT01506271|143003744|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|6.2|||||TWO_SIDED|95.0|-6.7|18.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||18.8|-6.7|
71747371|NCT01506271|143003745|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-10.3|2.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.4|-10.3|
71747372|NCT01506271|143003745|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-5.0|10.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||10.1|-5.0|
71747373|NCT01506271|143003746|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.0|||||TWO_SIDED|95.0|-4.5|12.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||12.7|-4.5|
71747374|NCT01506271|143003746|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-4.4|12.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||12.8|-4.4|
71747375|NCT01506271|143003747|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.0|3.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||3.9|-4.0|
71747376|NCT01506271|143003747|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.8|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-4.8|
71747377|NCT01506271|143003748|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||2.3|-6.7|
71747378|NCT01506271|143003748|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||7.4|-3.7|
71747379|NCT01506271|143003749|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.6|||||TWO_SIDED|95.0|-7.5|0.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0.6|-7.5|
71747380|NCT01506271|143003749|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-6.7|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||2.4|-6.7|
71747381|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.7|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Diarrhoea||8.1|-4.7|
71747382|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-4.6|8.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Diarrhoea||8.2|-4.6|
71747383|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nausea||6.9|-7.3|
71747384|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nausea||8.0|-6.5|
71891332|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.108|0.157||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.157|0.108|<0.0001
71891333|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.078|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.078|<0.0001
71891334|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.096|0.145||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.145|0.096|< 0.0001
71666414|NCT02503787|142847332|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.||||<0.01
71666415|NCT00174954|142847351|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||The a priori threshold for statistical significance was 0.05.|paired t-test|||||||0.785
71834988|NCT05450458|143174570|SUPERIORITY|This is a superiority analysis. Data normality was first assessed with the Shapiro-Wilk test, and due to non-normal distributions, a Wilcoxon Signed-Rank Test was applied to compare paired baseline and six-month KOOS score|Baseline to Month 6|18.5|||<|0.001|TWO_SIDED|95.0|13.0|22.0||The p-values reported were not adjusted for multiple comparisons, and the a priori threshold for statistical significance was set at p \< 0.05|Wilcoxon Signed-Rank Test|Friedman test conducted with 3 degrees of freedom. Bonferroni correction applied in pairwise Wilcoxon post hoc comparisons.|Median KOOS improvement from baseline to 6 months in 22 athletes with elevated BMI. CI calculated via bootstrap resampling (1,000 iterations). No comparator group was involved.|The analysis was conducted under the null hypothesis of no change in knee function between baseline and six months. The study was designed with sufficient power to detect clinically meaningful improvements, with significance determined at a conventional level||22|13|<0.001
71834989|NCT00262301|143174571|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|||||||0.003
71834990|NCT00262301|143174572|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Log Rank|||||||0.005
71834991|NCT02272816|143174581|OTHER||Percentage|95.6|||||ONE_SIDED|95.0||98.6||||||||98.6||
71834992|NCT02272816|143174582|OTHER||Percentage|45.0|||||TWO_SIDED|95.0|30.2|59.9||||||||59.9|30.2|
71834993|NCT02272816|143174583|OTHER||Percentage|100.0|||||TWO_SIDED|95.0|92.6|100.0||||||||100|92.6|
71834994|NCT00976937|143174587|SUPERIORITY_OR_OTHER||Response rate difference|4.6|STANDARD_ERROR_OF_MEAN|3.28||0.1696|TWO_SIDED|95.0|-1.84|11.0||Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata of screening HbA1c (\<8.0 or \>=8.0%) and randomization strata of screening BMI (\<35 or \>=35 kg/m\^2) was used.|Cochran-Mantel-Haenszel|||To demonstrate the superiority of lixisenatide over sitagliptin, 150 patients in each arm would provide a power of 90% with a 2-sided test at the 5% significance level, assuming the percentage of patients defined as responders on HbA1c (\<7%) and weight (at least 5% loss) is 25% with lixisenatide and 10% with sitagliptin.||11.00|-1.84|0.1696
71834995|NCT01227265|143174636|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.4933|TWO_SIDED|95.0|-0.72|0.35|||cLDA|||||0.35|-0.72|0.4933
71666416|NCT00174954|142847352|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The a priori threshold for statistical significance is 0.05.|paired t-test|||||||0.020
71834996|NCT01227265|143174636|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.3||||0.2364|TWO_SIDED|95.0|-0.86|0.21|||cLDA|||||0.21|-0.86|0.2364
71677377|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.888|||||TWO_SIDED|95.0|0.615|1.282||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.282|0.615|
71834997|NCT01227265|143174637|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|7.0||||0.244|TWO_SIDED|95.0|-4.17|18.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||18.05|-4.17|0.244
71834998|NCT01227265|143174637|SUPERIORITY_OR_OTHER||Estimated Difference in Percentage|6.5||||0.262|TWO_SIDED|95.0|-4.63|17.61||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis|||||17.61|-4.63|0.262
71834999|NCT01227265|143174638|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.776|TWO_SIDED|95.0|-0.47|0.63|||cLDA|||||0.63|-0.47|0.776
71835000|NCT01227265|143174638|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.1||||0.683|TWO_SIDED|95.0|-0.44|0.67|||cLDA|||||0.67|-0.44|0.683
71835001|NCT01227265|143174642|SUPERIORITY_OR_OTHER||Difference in Estimated Means|-0.2||||0.6968|TWO_SIDED|95.0|-0.92|0.61|||cLDA|||||0.61|-0.92|0.6968
71835002|NCT01227265|143174642|SUPERIORITY_OR_OTHER||Difference in Estimated Means|0.2||||0.6142|TWO_SIDED|95.0|-0.57|0.97|||cLDA|||||0.97|-0.57|0.6142
71835003|NCT03690206|143174643|SUPERIORITY||Difference to Placebo|-2.28||||0.0039|TWO_SIDED|95.0|-3.83|-0.73|||Mixed Models Analysis|||||-0.73|-3.83|0.0039
71835004|NCT03690206|143174643|SUPERIORITY||Difference to Placebo|-0.91||||0.27|TWO_SIDED|95.0|-2.52|0.71|||Mixed Models Analysis|||||0.71|-2.52|0.2700
71835005|NCT03690206|143174644|SUPERIORITY||Difference to Placebo|26.6||||0.0243|TWO_SIDED|95.0|4.3|48.9|||Cochran-Mantel-Haenszel|||||48.9|4.3|0.0243
71835006|NCT03690206|143174644|SUPERIORITY||Difference to Placebo|5.5||||0.6255|TWO_SIDED|95.0|-16.2|27.1|||Cochran-Mantel-Haenszel|||||27.1|-16.2|0.6255
71835007|NCT03690206|143174645|SUPERIORITY||Difference to Placebo|31.7||||0.0043|TWO_SIDED|95.0|11.4|51.9|||Cochran-Mantel-Haenszel|||||51.9|11.4|0.0043
71835008|NCT03690206|143174645|SUPERIORITY||Difference to Placebo|13.3||||0.1675|TWO_SIDED|95.0|-5.4|32.0|||Cochran-Mantel-Haenszel|||||32.0|-5.4|0.1675
71835009|NCT03690206|143174647|SUPERIORITY||Difference to Placebo|14.1||||0.016|TWO_SIDED|95.0|2.5|25.6|||Cochran-Mantel-Haenszel|||||25.6|2.5|0.0160
71835010|NCT03690206|143174647|SUPERIORITY||Difference to Placebo|11.2||||0.0424|TWO_SIDED|95.0|0.7|21.6|||Cochran-Mantel-Haenszel|||||21.6|0.7|0.0424
71845279|NCT05886777|143204392|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 4, respectively.|Geometric mean ratio|1.27|||||TWO_SIDED|97.5|0.977|1.651|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.651|0.977|
71677378|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.12|||||TWO_SIDED|95.0|1.473|3.052||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.052|1.473|
71845280|NCT05886777|143204393|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7,3, respectively.|Geometric mean ratio|0.86|||||TWO_SIDED|97.5|0.61|1.208|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.208|0.610|
71845281|NCT05886777|143204394|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 7, 3, respectively.|Geometric mean ratio|1.01|||||TWO_SIDED|97.5|0.764|1.34|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.340|0.764|
71845282|NCT05886777|143204395|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|2.49|||||TWO_SIDED|97.5|1.914|3.232|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||3.232|1.914|
71845283|NCT05886777|143204396|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.3|||||TWO_SIDED|97.5|1.049|1.612|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.612|1.049|
71845284|NCT05886777|143204397|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|1.58|||||TWO_SIDED|97.5|1.155|2.165|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||2.165|1.155|
71845285|NCT05886777|143204398|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 7,5, respectively.|Geometric mean ratio|3.49|||||TWO_SIDED|97.5|2.64|4.604|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||4.604|2.640|
71677005|NCT01683266|142872375|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.098|0.185||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.185|-0.098|
71779929|NCT05338216|143059434|SUPERIORITY||Mean Difference (Final Values)|19.63||||0.021||95.0|4.37|36.24||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Compliance would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||36.24|4.37|0.021
71779930|NCT05338216|143059435|SUPERIORITY||Mean Difference (Final Values)|17.34||||0.027||95.0|0.78|32.77||Threshold for significance: p \< 0.05. No correction for multiple comparisons performed due to only two tests conducted and exploratory nature of this pilot study.|Wilcoxon (Mann-Whitney)|||Hypothesis: Completion would be significantly higher for micro-interaction based versus traditional EMA. Null hypothesis: No difference between conditions.||32.77|0.78|0.027
71835011|NCT03012841|143174657|SUPERIORITY|The formal alternative hypothesis test for the primary effectiveness objective was that the Kaplan-Meier estimator of treatment success at 12 months (365 days) was greater than 40%, against the null hypothesis that it was less than or equal to 40%.|Kaplan-Meier (product-limit) estimator|54.8|||<|0.001|TWO_SIDED|95.0|46.7|62.1|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||62.1|46.7|<0.001
71747385|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|3.4|||||TWO_SIDED|95.0|-2.3|9.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vomiting||9.6|-2.3|
71747386|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.1|||||TWO_SIDED|95.0|-0.7|11.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vomiting||11.8|-0.7|
71747387|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.6|3.5|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Postoperative Infection||3.5|-7.6|
71747388|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Postoperative Infection||2.2|-8.4|
71747389|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.9|||||TWO_SIDED|95.0|-2.4|4.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Seroma||4.7|-2.4|
71747390|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.3|||||TWO_SIDED|95.0|1.0|9.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Seroma||9.7|1.0|
71747391|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-5.0|6.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - ALT increased||6.6|-5.0|
71747392|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.9|6.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - ALT increased||6.7|-4.9|
71747393|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-3.7|7.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - AST increased||7.3|-3.7|
71747394|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - AST increased||7.4|-3.7|
71747395|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.5|4.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Lipase increased||4.2|-6.5|
71747396|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Lipase increased||3.0|-7.2|
71747397|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.5|||||TWO_SIDED|95.0|-8.7|-0.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Hypertension||-0.3|-8.7|
71747398|NCT01506271|143003750|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.4|4.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Hypertension||4.3|-6.4|
71747399|NCT01506271|143003751|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||0|0|> 0.999
71666417|NCT00839254|142847353|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
71666418|NCT00839254|142847354|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster-related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
71666419|NCT02374138|142847451|SUPERIORITY|||||||0.93||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Months||||0.93
71666420|NCT02374138|142847452|SUPERIORITY|||||||0.87||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 month follow up||||0.87
71666421|NCT02374138|142847452|SUPERIORITY|||||||0.25||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.25
71666422|NCT02374138|142847454|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 6 Month Follow Up||||0.35
71666423|NCT02374138|142847454|SUPERIORITY|||||||0.34||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 12 Month Follow Up||||0.34
71666424|NCT02374138|142847454|SUPERIORITY|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA Use at 6 Months||||0.35
71666425|NCT02374138|142847454|SUPERIORITY|||||||0.62||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA use at 12 Month Follow Up||||0.62
71666426|NCT02374138|142847455|SUPERIORITY|||||||0.63||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED visits over 6 months||||0.63
71747400|NCT01506271|143003751|SUPERIORITY||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||0|0|> 0.999
71891335|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.131|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.106|0.155||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.155|0.106|<0.0001
71891336|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.066|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.115|0.066|<0.0001
71666427|NCT02374138|142847455|SUPERIORITY|||||||0.44||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED Visits between 6 and 12 Month follow up||||0.44
71666428|NCT02374138|142847456|SUPERIORITY|||||||0.98||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids over 6 months||||0.98
71666429|NCT02374138|142847456|SUPERIORITY|||||||0.48||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids between 6m and 12m FU||||0.48
71666430|NCT02374138|142847457|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.32
71666431|NCT02374138|142847457|SUPERIORITY|||||||0.06||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.06
71747401|NCT01506271|143003752|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.4||||0.001|TWO_SIDED|95.0|-9.1|6.0|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.0|-9.1|0.001
71747402|NCT01506271|143003752|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-2.1||||0.002|TWO_SIDED|95.0|-9.7|5.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||5.3|-9.7|0.002
71747403|NCT01506271|143003753|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-6.3|6.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.2|-6.3|< 0.001
71779931|NCT02653872|143059454|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with verapamil over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|153.4|||||TWO_SIDED|90.0|136.16|172.83|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||172.83|136.16|
71779932|NCT02653872|143059454|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of Cmax for AZD7986 administered with itraconazole over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|60.66|||||TWO_SIDED|90.0|53.84|68.34|||ANOVA|||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.||68.34|53.84|
71779933|NCT02653872|143059455|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with verapamil over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|132.25|||||TWO_SIDED|90.0|121.78|143.64|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||143.64|121.78|
71779934|NCT02653872|143059455|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC for AZD7986 administered with itraconazole over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|113.7|||||TWO_SIDED|90.0|104.69|123.49|||ANOVA|||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.||123.49|104.69|
71779935|NCT02653872|143059456|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with verapamil over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|133.51|||||TWO_SIDED|90.0|122.7|145.29|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||145.29|122.70|
71779936|NCT02653872|143059456|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of AUC (0-t) for AZD7986 administered with itraconazole over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|112.45|||||TWO_SIDED|90.0|103.34|122.37|||ANOVA|||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.||122.37|103.34|
71779937|NCT04472429|143059473|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0006|TWO_SIDED|95.0|0.47|0.84||tested at the 1-sided 2.5% level|stratified log-rank test||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.84|0.47|0.0006
71779938|NCT04545060|143059489|SUPERIORITY||adjusted relative risk ratio|0.21|||<|0.001|TWO_SIDED|95.0|0.09|0.5||two-sided, alpha=0.05|poisson regression model|||||0.50|0.09|<0.001
71779939|NCT04545060|143059507|SUPERIORITY||relative risk ratio|0.34|||<|0.001|TWO_SIDED|95.0|0.19|0.63||two-sided, alpha=0.05|poisson regression model|||||0.63|0.19|<0.001
71779940|NCT04545060|143059508|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.38|-0.76||two-sided, alpha=0.05|ANCOVA|||||-0.76|-1.38|<0.001
71779941|NCT04545060|143059510|SUPERIORITY||Least squares mean difference|-0.232||||0.007|TWO_SIDED|95.0|-0.399|-0.065||two-sided, alpha=0.05|Mixed model repeated measures|||||-0.065|-0.399|0.007
71891337|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3394|TWO_SIDED|95.0|-0.013|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.036|-0.013|0.3394
71891338|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.118|0.167||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.167|0.118|<0.0001
71891339|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0173|TWO_SIDED|95.0|0.005|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.005|0.0173
71779942|NCT04545060|143059514|SUPERIORITY||relative risk ratio|0.26||||0.002|TWO_SIDED|95.0|0.12|0.59||two-sided, alpha=0.05|poisson regression model|||||0.59|0.12|0.002
71779943|NCT02319837|143059527|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.424|||<|0.0001|TWO_SIDED|95.0|0.296|0.607||Statistical significance can be declared if p-value \<0.05.|Log Rank|||||0.607|0.296|<0.0001
71779944|NCT02319837|143059528|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.631||||0.0049|TWO_SIDED|95.0|0.456|0.871||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.871|0.456|0.0049
71747404|NCT01506271|143003753|NON_INFERIORITY|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|2.4|||<|0.001|TWO_SIDED|95.0|-2.0|8.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.3|-2.0|< 0.001
71747405|NCT01506271|143003754|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.7|6.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.4|-6.7|< 0.001
71747406|NCT01506271|143003754|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.1|||<|0.001|TWO_SIDED|95.0|-6.3|6.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||6.5|-6.3|< 0.001
71747407|NCT01506271|143003755|NON_INFERIORITY|Non-inferiority test based on Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.3||||0.002|TWO_SIDED|95.0|-9.6|6.9|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||6.9|-9.6|0.002
71747408|NCT01506271|143003755|NON_INFERIORITY|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-7.2|8.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.2|-7.2|< 0.001
71747409|NCT01506271|143003756|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-7.4|7.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference||7.4|-7.4|< 0.001
71747410|NCT01506271|143003756|NON_INFERIORITY|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|1.4|||<|0.001|TWO_SIDED|95.0|-5.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference||8.6|-5.2|< 0.001
71747411|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Blood, lymphatic||5.1|-7.3|
71779945|NCT02319837|143059529|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.068|||<|0.0001|TWO_SIDED|95.0|0.033|0.141||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.141|0.033|<0.0001
71779946|NCT02319837|143059529|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.331|||<|0.0001|TWO_SIDED|95.0|0.226|0.486||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.486|0.226|<0.0001
71779947|NCT02319837|143059530|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.358|||<|0.0001|TWO_SIDED|95.0|0.263|0.488||Statistical significance can be declared if p-value \<0.02.|Log Rank|||||0.488|0.263|<0.0001
71779948|NCT02319837|143059530|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.411|0.709||Statistical significance can be declared if p-value \<0.03.|Log Rank|||||0.709|0.411|<0.0001
71747412|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.3|0.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Blood, lymphatic||0.1|-10.3|
71835012|NCT03012841|143174658|SUPERIORITY|The formal alternative hypothesis tested for the primary safety objective was that the Kaplan-Meier estimator of the proportion of subjects with primary safety events at 12 months (365 days) was less than 13%, against the null hypothesis that it was greater than or equal to 13%.|Kaplan-Meier (product-limit) estimator|0.6||||0.002|TWO_SIDED|95.0|0.1|4.4|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.4|0.1|0.002
71747413|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-5.2|5.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Cardiac disorder||5.0|-5.2|
71891340|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.013||0.421|TWO_SIDED|95.0|-0.035|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.014|-0.035|0.4210
71747414|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Cardiac disorder||6.3|-4.5|
71747415|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.6|||||TWO_SIDED|95.0|-3.9|15.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - GI disorders||15.3|-3.9|
71747416|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-5.4|13.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - GI disorders||13.6|-5.4|
71747417|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.2|||||TWO_SIDED|95.0|-2.0|11.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Gen. dis \& admin.||11.0|-2.0|
71891341|NCT01431287|143304548|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|0.015|0.0014
71666432|NCT02374138|142847458|SUPERIORITY|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month follow up||||0.32
71747418|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||TWO_SIDED|95.0|-4.2|7.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Gen. dis \& admin.||7.8|-4.2|
71747419|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||TWO_SIDED|95.0|-3.6|12.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Infect. \& Infest.||12.0|-3.6|
71747420|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||TWO_SIDED|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Infect. \& Infest.||8.0|-6.5|
71747421|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Injury, poison.||5.1|-7.3|
71747422|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||TWO_SIDED|95.0|-5.0|8.5|||||Relebactam minus Placebo|Relebactam 1250mg - Placebo: Percentage Difference - Injury, poison.||8.5|-5.0|
71747423|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.2|||||TWO_SIDED|95.0|-9.8|7.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Investigations||7.4|-9.8|
71747424|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.9|||||TWO_SIDED|95.0|-10.5|6.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Investigations||6.5|-10.5|
71747425|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
71747426|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nervous System||2.2|-8.4|
71747427|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Psychiatric disorders||5.4|-5.7|
71747428|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-5.7|5.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Psychiatric disorders||5.5|-5.7|
71747429|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
71747430|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Renal \& Urinary||3.0|-7.2|
71747431|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||TWO_SIDED|95.0|-10.7|0.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Resp. \& chest||0.7|-10.7|
71747432|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||TWO_SIDED|95.0|-8.4|4.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Resp. \& chest||4.4|-8.4|
71747433|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||TWO_SIDED|95.0|-2.4|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Skin \& subcutan.||8.1|-2.4|
71747434|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||TWO_SIDED|95.0|-4.7|4.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Skin \& subcutan.||4.5|-4.7|
71747435|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||TWO_SIDED|95.0|-9.9|2.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vascular disorders||2.0|-9.9|
71747436|NCT01506271|143003758|OTHER|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||TWO_SIDED|95.0|-6.9|6.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vascular disorders||6.6|-6.9|
71747437|NCT00539994|143003780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71747438|NCT00539994|143003780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71747439|NCT03071263|143003789|SUPERIORITY||||||<|0.0001||||||α-level 0.05. Stratified by baseline potassium category (4.3-\<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized|Cochran-Mantel-Haenszel|||A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.||||<0.0001
71747440|NCT03071263|143003790|SUPERIORITY|||||||0.5757||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as factors in the model.|ANCOVA|||||||0.5757
71747441|NCT03071263|143003791|SUPERIORITY|||||||0.6367||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-\<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus as factors in the model.|ANCOVA|||The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.||||0.6367
71666433|NCT02374138|142847458|SUPERIORITY|||||||0.44||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up||||0.44
71666434|NCT02374138|142847459|SUPERIORITY|||||||0.7||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up||||0.70
71747442|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.037|TWO_SIDED|95.0|0.003|0.132|||Mixed Models Analysis|||"Comparison groups were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.132|0.003|0.037
71747443|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.116|||<|0.001|TWO_SIDED|95.0|0.051|0.181|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.181|0.051|<0.001
71891342|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.063|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.063|<0.0001
71747444|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.151|||<|0.001|TWO_SIDED|95.0|0.086|0.216|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.216|0.086|<0.001
71779949|NCT02319837|143059532|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.443||||0.0002|TWO_SIDED|95.0|0.284|0.69|||Log Rank|||||0.690|0.284|0.0002
71779950|NCT02319837|143059532|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.614||||0.0171|TWO_SIDED|95.0|0.409|0.92|||Log Rank|||||0.920|0.409|0.0171
71779951|NCT02319837|143059533|OTHER||difference of percentage of participants|25.9|||<|0.0001|TWO_SIDED|95.0|20.7|31.0||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||31.0|20.7|<0.0001
71779952|NCT02319837|143059533|OTHER||difference of percentage of participants|18.8|||<|0.0001|TWO_SIDED|95.0|13.0|24.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||24.6|13.0|<0.0001
71779953|NCT02319837|143059534|OTHER||difference of percentage of participants|7.5||||0.0439|TWO_SIDED|95.0|-0.2|15.2||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||15.2|-0.2|0.0439
71891343|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.024|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.075|0.024|0.0001
71666435|NCT02374138|142847459|SUPERIORITY|||||||0.8||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up||||0.80
71666436|NCT02374138|142847460|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||6 Month Follow Up||||0.53
71666437|NCT02374138|142847460|SUPERIORITY|||||||0.77||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||12 Month Follow up||||0.77
71666438|NCT02374138|142847461|SUPERIORITY|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 6 Month Follow up||||0.53
71666439|NCT02374138|142847461|SUPERIORITY|||||||0.57||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 12 Month Follow up||||0.57
71666440|NCT02374138|142847462|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71666441|NCT02374138|142847465|SUPERIORITY|||||||0.58||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on Brief COPE at 12 Months||||0.58
71666442|NCT02374138|142847467|SUPERIORITY|||||||0.46||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 6 Month Follow Up||||0.46
71779954|NCT02319837|143059534|OTHER||difference of percentage of participants|-12.9||||0.0004|TWO_SIDED|95.0|-19.8|-6.1||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-6.1|-19.8|0.0004
71779955|NCT02319837|143059535|OTHER||difference of percentage of participants|7.2||||0.0089|TWO_SIDED|95.0|1.7|12.8||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||12.8|1.7|0.0089
71779956|NCT02319837|143059535|OTHER||difference of percentage of participants|-5.0||||0.0326|TWO_SIDED|95.0|-9.4|-0.6||P-value was based on a Cochran-Mantel-Haenszel test stratified by screening PSA, PSA doubling time, and prior hormonal therapy.|Cochran-Mantel-Haenszel|||||-0.6|-9.4|0.0326
71666443|NCT02374138|142847467|SUPERIORITY|||||||0.62||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 12 Month Follow Up||||0.62
71666444|NCT02374138|142847469|SUPERIORITY|By repeated measures, p-value adjusted for age and gender||||||0.35|||||||Generalized Linear Model Analysis|||||||0.35
71666445|NCT02374138|142847470|SUPERIORITY|Daytime asthma symptoms in prior 14d at 6-month follow up||||||0.54|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.54
71666446|NCT02374138|142847470|SUPERIORITY|Daytime Asthma Symptoms at 12 month follow up||||||0.11|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.11
71666447|NCT02374138|142847470|SUPERIORITY|Days of Activity Limitations at 6 month follow up||||||0.82|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.82
71666448|NCT02374138|142847470|SUPERIORITY|Days of Activity Limitations at 12 month follow up||||||0.84|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.84
71747445|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.145|||<|0.001|TWO_SIDED|95.0|0.081|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis for was performed as described for the statistical analysis 1 for this outcome measure.~Adjusted for multiplicity based on the parametric simulation method by Edwards and Berry."||0.209|0.081|<0.001
71747446|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.211|||<|0.001|TWO_SIDED|95.0|0.159|0.263|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.263|0.159|<0.001
71747447|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.066|TWO_SIDED|95.0|-0.003|0.1|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.100|-0.003|0.066
71666449|NCT02374138|142847470|SUPERIORITY|Days of Quick Relief Medicine Use at 6 month follow up||||||0.7|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.70
71747448|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.002|TWO_SIDED|95.0|0.031|0.135|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.135|0.031|0.002
71779957|NCT02319837|143059536|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.693|||<|0.0001|TWO_SIDED|95.0|0.577|0.834|||Log Rank|||||0.834|0.577|<0.0001
71666450|NCT02374138|142847470|SUPERIORITY|Days of Quick Relief Medicine Use at 12 month follow up||||||0.58|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender||||||0.58
71666451|NCT02374138|142847471|OTHER|Univariate test||||||0.2|||||||Chi-squared|||Parent education||||0.20
71666452|NCT02374138|142847472|SUPERIORITY|||||||0.91||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS exposure at 6 Month Follow Up||||0.91
71666453|NCT02374138|142847472|SUPERIORITY|||||||0.98||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS Exposure at 12 Month Follow up||||0.98
71666454|NCT02374138|142847473|OTHER|Univariate test||||||0.94|||||||Chi-squared|||||||0.94
71666455|NCT02374138|142847474|SUPERIORITY|||||||0.02||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 6 Months||||0.02
71666456|NCT02374138|142847474|SUPERIORITY|||||||0.85||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 12 Months||||0.85
71666457|NCT02374138|142847475|OTHER|Univariate test||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
71666458|NCT01377012|142847497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
71666459|NCT01377012|142847497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0004|TWO_SIDED|95.0|1.4|3.4|||Regression, Logistic|||||3.4|1.4|0.0004
71666460|NCT03736031|142847534|SUPERIORITY|||||||0.09|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.09
71666461|NCT03736031|142847535|SUPERIORITY|||||||0.81|||||||two-sample independent t-test|An alpha of 0.05 was used.||||||0.81
71666462|NCT03736031|142847536|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71666463|NCT03736031|142847537|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71666464|NCT02260570|142847567|SUPERIORITY||F value|24.1|||<|0.0001|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,1,60) = 24.1, p \< 0.0001, adjusted r\^2 = 0.275||||||<0.0001
71666465|NCT02260570|142847568|SUPERIORITY||F value|6.23||||0.0184|TWO_SIDED|||||This p-value is adjusted for multiple comparisons.|ANOVA|F(1,30) = 6.23, p = 0.0184, adjusted r\^2 = 0.144||||||0.0184
71666466|NCT05026177|142847569|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.5335|TWO_SIDED|95.0|-0.96|1.86|||Mixed Models Analysis|||||1.86|-0.96|0.5335
71666467|NCT05026177|142847569|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.5836|TWO_SIDED|95.0|-0.99|1.76|||Mixed Models Analysis|||||1.76|-0.99|0.5836
71666468|NCT05026177|142847570|SUPERIORITY||Mean Difference (Final Values)|-1.57||||0.0763|TWO_SIDED|95.0|-3.3|0.17|||Mixed Models Analysis|||||0.17|-3.30|0.0763
71666469|NCT05026177|142847570|SUPERIORITY||Mean Difference (Final Values)|-1.24||||0.153|TWO_SIDED|95.0|-2.93|0.46|||Mixed Models Analysis|||||0.46|-2.93|0.1530
71666470|NCT04856917|142847582|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.21||0.3757|TWO_SIDED|90.0|-2.47|8.19|||LRMM|||Least square (LS) Mean, SE, 90% CI, \& p-value was based on a linear repeated measures model (LRMM) which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||8.19|-2.47|0.3757
71666471|NCT04856917|142847582|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|3.22||0.6183|TWO_SIDED|90.0|-3.73|6.95|||LRMM|||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.||6.95|-3.73|0.6183
71666472|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.7||0.249|TWO_SIDED|90.0|-0.85|4.8||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||4.80|-0.85|0.2490
71666473|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.72||0.0708|TWO_SIDED|90.0|0.28|5.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.99|0.28|0.0708
71666474|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|7.9|STANDARD_ERROR_OF_MEAN|2.68||0.004|TWO_SIDED|90.0|3.44|12.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||12.34|3.44|0.0040
71666475|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.71||0.206|TWO_SIDED|90.0|-1.05|7.94||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||7.94|-1.05|0.2060
71747449|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.003|TWO_SIDED|95.0|0.026|0.128|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.128|0.026|0.003
71747450|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.035||||0.189|TWO_SIDED|95.0|-0.017|0.087|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.087|-0.017|0.189
71747451|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.273|TWO_SIDED|95.0|-0.023|0.08|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.080|-0.023|0.273
71747452|NCT03084796|143003799|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.813|TWO_SIDED|95.0|-0.058|0.045|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Analyzed using a linear mixed model for repeated measures (MMRM) including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West) and smoking status at screening as fixed effects, and the baseline value and baseline by visit interaction as covariates."||0.045|-0.058|0.813
71666476|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.66||0.4341|TWO_SIDED|90.0|-2.33|6.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||6.51|-2.33|0.4341
71666477|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.73||0.7307|TWO_SIDED|90.0|-3.59|5.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||5.48|-3.59|0.7307
71666478|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.93||0.3261|TWO_SIDED|90.0|-1.97|7.77||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||7.77|-1.97|0.3261
71666479|NCT04856917|142847583|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.95||0.8221|TWO_SIDED|90.0|-5.56|4.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||4.23|-5.56|0.8221
71666480|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|6.2||0.3008|TWO_SIDED|90.0|-3.84|16.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||16.73|-3.84|0.3008
71666481|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|6.27||0.0878|TWO_SIDED|90.0|0.4|21.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||21.19|0.40|0.0878
71666482|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|26.6|STANDARD_ERROR_OF_MEAN|8.42||0.002|TWO_SIDED|90.0|12.64|40.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||40.57|12.64|0.0020
71666483|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|14.0|STANDARD_ERROR_OF_MEAN|8.5||0.1029|TWO_SIDED|90.0|-0.12|28.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||28.09|-0.12|0.1029
71666484|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|8.82||0.5427|TWO_SIDED|90.0|-9.25|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||20.02|-9.25|0.5427
71666485|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|9.06||0.5833|TWO_SIDED|90.0|-10.05|20.02||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||20.02|-10.05|0.5833
71666486|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|10.8|STANDARD_ERROR_OF_MEAN|10.98||0.3293|TWO_SIDED|90.0|-7.46|28.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||28.99|-7.46|0.3293
71747453|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.002|TWO_SIDED|95.0|0.022|0.095|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.095|0.022|0.002
71747454|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.04|0.113|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.113|0.040|<0.001
71747455|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.089|0.163|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.163|0.089|<0.001
71747456|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.104|0.177|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.177|0.104|<0.001
71747457|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.147|0.22|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.220|0.147|<0.001
71747458|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.322|TWO_SIDED|95.0|-0.018|0.055|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.055|-0.018|0.322
71666487|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|14.5|STANDARD_ERROR_OF_MEAN|10.99||0.19|TWO_SIDED|90.0|-3.74|32.74||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||32.74|-3.74|0.1900
71747459|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.067|||<|0.001|TWO_SIDED|95.0|0.031|0.104|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.104|0.031|<0.001
71747460|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.082|||<|0.001|TWO_SIDED|95.0|0.045|0.118|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.118|0.045|<0.001
71666488|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|11.7|STANDARD_ERROR_OF_MEAN|9.38||0.2168|TWO_SIDED|90.0|-3.91|27.23||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||27.23|-3.91|0.2168
71835013|NCT03012841|143174659|SUPERIORITY||Mean Difference (Net)|25.8|||<|0.001|TWO_SIDED|95.0|22.1|29.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in AFEQT composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||29.5|22.1|<0.001
71666489|NCT04856917|142847584|SUPERIORITY||LS Mean Difference|7.8|STANDARD_ERROR_OF_MEAN|9.42||0.4089|TWO_SIDED|90.0|-7.82|23.45||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial inflammatory lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||23.45|-7.82|0.4089
71747461|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.008|TWO_SIDED|95.0|0.013|0.086|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.086|0.013|0.008
71747462|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.063|||<|0.001|TWO_SIDED|95.0|0.027|0.1|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.100|0.027|<0.001
71747463|NCT03084796|143003800|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.443|TWO_SIDED|95.0|-0.022|0.051|||Mixed Models Analysis|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 for this outcome measure."||0.051|-0.022|0.443
71747464|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.072|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.105|0.038|<0.001
71747465|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.086|||<|0.001|TWO_SIDED|95.0|0.052|0.119|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.119|0.052|<0.001
71747466|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.143|||<|0.001|TWO_SIDED|95.0|0.109|0.177|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.177|0.109|<0.001
71747467|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.127|0.194|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.194|0.127|<0.001
71747468|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.164|||<|0.001|TWO_SIDED|95.0|0.131|0.198|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.198|0.131|<0.001
71747469|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.418|TWO_SIDED|95.0|-0.02|0.048|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.048|-0.020|0.418
71747470|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.071|||<|0.001|TWO_SIDED|95.0|0.038|0.105|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.105|0.038|<0.001
71747471|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.089|||<|0.001|TWO_SIDED|95.0|0.055|0.122|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.122|0.055|<0.001
71747472|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.057|||<|0.001|TWO_SIDED|95.0|0.024|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|0.024|<0.001
71835014|NCT03012841|143174660|SUPERIORITY||Mean Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|3.5|6.5||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 physical composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.5|3.5|<0.001
71835015|NCT03012841|143174661|SUPERIORITY||Mean Difference (Net)|4.9|||<|0.001|TWO_SIDED|95.0|3.2|6.6||A Hommel multiple testing procedure was utilized to maintain overall alpha of 0.025 for the 3 hypotheses tested for the secondary objective.|t-test, 1 sided|||The formal alternative hypothesis tested was that the mean 12-month change in SF-12 mental composite scores was greater than 0, against the null the hypothesis that it was equal to 0.||6.6|3.2|<0.001
71835016|NCT04491968|143174688|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.02|TWO_SIDED|95.0|0.37|0.9|||proportional hazard regression|||||.90|.37|.02
71666490|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.53||0.4229|TWO_SIDED|90.0|-2.16|6.24||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||6.24|-2.16|0.4229
71666491|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.56||0.6027|TWO_SIDED|90.0|-2.91|5.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||5.59|-2.91|0.6027
71666492|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|2.5||0.2655|TWO_SIDED|90.0|-1.35|6.95||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||6.95|-1.35|0.2655
71747473|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.041|0.108|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|0.041|<0.001
71747474|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.308|TWO_SIDED|95.0|-0.016|0.051|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.051|-0.016|0.308
71747475|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.092|||<|0.001|TWO_SIDED|95.0|0.038|0.147|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.147|0.038|<0.001
71747476|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.133|||<|0.001|TWO_SIDED|95.0|0.079|0.188|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.188|0.079|<0.001
71891344|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.042|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.092|0.042|<0.0001
71747477|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.174|||<|0.001|TWO_SIDED|95.0|0.12|0.229|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.229|0.120|<0.001
71747478|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.181|||<|0.001|TWO_SIDED|95.0|0.127|0.235|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.127|<0.001
71835017|NCT04491968|143174689|SUPERIORITY||Hazard Ratio (HR)|0.41||||0.04|TWO_SIDED|95.0|0.18|0.96|||proportional hazard regression|||||.96|.18|.04
71835018|NCT05857644|143174697|OTHER||Geometric mean ratio|84.33|||||TWO_SIDED|90.0|50.94|139.59|||||Mild Hepatic Impairment versus No Hepatic Impairment|||139.59|50.94|
71835019|NCT05857644|143174697|OTHER||Geometric mean ratio|90.89|||||TWO_SIDED|90.0|54.91|150.45|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||150.45|54.91|
71666493|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|2.53||0.6229|TWO_SIDED|90.0|-2.95|5.44||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||5.44|-2.95|0.6229
71835020|NCT05857644|143174697|OTHER||Geometric mean ratio|157.23|||||TWO_SIDED|90.0|84.81|291.49|||||Severe Hepatic Impairment versus No Hepatic Impairment|||291.49|84.81|
71835021|NCT05857644|143174698|OTHER||Geometric mean ratio|82.17|||||TWO_SIDED|90.0|49.24|137.11|||||Mild Hepatic Impairment versus No Hepatic Impairment|||137.11|49.24|
71835022|NCT05857644|143174698|OTHER||Geometric mean ratio|130.82|||||TWO_SIDED|90.0|78.4|218.3|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||218.30|78.40|
71835023|NCT05857644|143174698|OTHER||Geometric mean ratio|385.52|||||TWO_SIDED|90.0|205.92|721.77|||||Severe Hepatic Impairment versus No Hepatic Impairment|||721.77|205.92|
71747479|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.229|||<|0.001|TWO_SIDED|95.0|0.175|0.284|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.284|0.175|<0.001
71747480|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.141|TWO_SIDED|95.0|-0.013|0.095|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.013|0.141
71747481|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.082||||0.003|TWO_SIDED|95.0|0.028|0.137|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.137|0.028|0.003
71747482|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.001|TWO_SIDED|95.0|0.035|0.142|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.142|0.035|0.001
71747483|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.041||||0.137|TWO_SIDED|95.0|-0.013|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.013|0.137
71747484|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.082|TWO_SIDED|95.0|-0.006|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.006|0.082
71747485|NCT03084796|143003801|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.823|TWO_SIDED|95.0|-0.048|0.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.060|-0.048|0.823
71747486|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.002|TWO_SIDED|95.0|0.022|0.1|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.100|0.022|0.002
71747487|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.075|||<|0.001|TWO_SIDED|95.0|0.036|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|0.036|<0.001
71747488|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.085|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.085|<0.001
71747489|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.152|||<|0.001|TWO_SIDED|95.0|0.113|0.19|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|0.113|<0.001
71747490|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.163|||<|0.001|TWO_SIDED|95.0|0.124|0.202|||MMRM|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.202|0.124|<0.001
71747491|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.485|TWO_SIDED|95.0|-0.025|0.052|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.052|-0.025|0.485
71747492|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.001|TWO_SIDED|95.0|0.025|0.102|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.102|0.025|0.001
71747493|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.091|||<|0.001|TWO_SIDED|95.0|0.053|0.13|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|0.053|<0.001
71835024|NCT05857644|143174699|OTHER||Geometric mean ratio|82.99|||||TWO_SIDED|90.0|50.53|136.28|||||Mild Hepatic Impairment versus No Hepatic Impairment|||136.28|50.53|
71747494|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.012|TWO_SIDED|95.0|0.011|0.088|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.088|0.011|0.012
71835025|NCT05857644|143174699|OTHER||Geometric mean ratio|131.52|||||TWO_SIDED|90.0|80.09|215.99|||||Moderate Hepatic Impairment versus No Hepatic Impairment|||215.99|80.09|
71835026|NCT05857644|143174699|OTHER||Geometric mean ratio|392.1|||||TWO_SIDED|90.0|213.57|719.85|||||Severe Hepatic Impairment versus No Hepatic Impairment|||719.85|213.57|
71666494|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|3.74||0.4091|TWO_SIDED|90.0|-3.1|9.3||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||9.30|-3.10|0.4091
71666495|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|3.83||0.1274|TWO_SIDED|90.0|-0.47|12.25||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||12.25|-0.47|0.1274
71666496|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|3.76||0.2075|TWO_SIDED|90.0|-1.47|11.01||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||11.01|-1.47|0.2075
71666497|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|3.77||0.2484|TWO_SIDED|90.0|-1.88|10.64||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||10.64|-1.88|0.2484
71666498|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.61||0.3399|TWO_SIDED|90.0|-2.53|9.45||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.45|-2.53|0.3399
71666499|NCT04856917|142847585|SUPERIORITY||LS Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|3.62||0.0545|TWO_SIDED|90.0|1.03|13.05||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||13.05|1.03|0.0545
71666500|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|11.69||0.9679|TWO_SIDED|90.0|-19.86|18.91||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||18.91|-19.86|0.9679
71666501|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|11.83||0.9152|TWO_SIDED|90.0|-20.87|18.35||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||18.35|-20.87|0.9152
71666502|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|9.64||0.449|TWO_SIDED|90.0|-8.67|23.32||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||23.32|-8.67|0.4490
71835027|NCT04878354|143174730|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.0004|TWO_SIDED|95.0|0.58|2.0|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||2.00|0.58|0.0004
71666503|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|9.74||0.7246|TWO_SIDED|90.0|-12.72|19.6||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.60|-12.72|0.7246
71666504|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|13.8|STANDARD_ERROR_OF_MEAN|18.88||0.4655|TWO_SIDED|90.0|-17.49|45.14||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||45.14|-17.49|0.4655
71666505|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|19.33||0.1178|TWO_SIDED|90.0|-1.59|62.54||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||62.54|-1.59|0.1178
71666506|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|17.71||0.1938|TWO_SIDED|90.0|-6.22|52.52||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||52.52|-6.22|0.1938
71835028|NCT04878354|143174731|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.001|TWO_SIDED|95.0|0.34|1.35|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||1.35|0.34|0.0010
71747495|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.077|||<|0.001|TWO_SIDED|95.0|0.039|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|0.039|<0.001
71747496|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.028||||0.157|TWO_SIDED|95.0|-0.011|0.066|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.066|-0.011|0.157
71747497|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.021|TWO_SIDED|95.0|0.011|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.011|0.021
71747498|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.112|||<|0.001|TWO_SIDED|95.0|0.053|0.17|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.053|<0.001
71747499|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.103|0.22|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.220|0.103|<0.001
71747500|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.157|||<|0.001|TWO_SIDED|95.0|0.099|0.215|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.215|0.099|<0.001
71747501|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.154|0.271|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.271|0.154|<0.001
71747502|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.149|TWO_SIDED|95.0|-0.015|0.101|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.101|-0.015|0.149
71747503|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.092||||0.002|TWO_SIDED|95.0|0.034|0.151|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.151|0.034|0.002
71835029|NCT04878354|143174732|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.0354|TWO_SIDED|95.0|0.03|0.71|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.71|0.03|0.0354
71835030|NCT04878354|143174733|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.0734|TWO_SIDED|95.0|-0.02|0.5|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Adjusted p-value.||0.50|-0.02|0.0734
71835031|NCT04878354|143174734|SUPERIORITY||Mean Difference (Final Values)|0.86|||<|0.0001|TWO_SIDED|95.0|0.45|1.28|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.28|0.45|<0.0001
71835032|NCT04878354|143174735|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.0002|TWO_SIDED|95.0|0.26|0.82|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.82|0.26|0.0002
71891345|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.087|0.037|<0.0001
71747504|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.088||||0.003|TWO_SIDED|95.0|0.031|0.146|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.031|0.003
71747505|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.096|TWO_SIDED|95.0|-0.009|0.108|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.108|-0.009|0.096
71747506|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.122|TWO_SIDED|95.0|-0.012|0.103|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.103|-0.012|0.122
71747507|NCT03084796|143003802|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.886|TWO_SIDED|95.0|-0.062|0.054|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.054|-0.062|0.886
71779958|NCT02319837|143059536|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.655|||<|0.0001|TWO_SIDED|95.0|1.381|1.984|||Log Rank|||||1.984|1.381|<0.0001
71666507|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|29.7|STANDARD_ERROR_OF_MEAN|17.85||0.0991|TWO_SIDED|90.0|0.08|59.29||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||59.29|0.08|0.0991
71779959|NCT02319837|143059537|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.09|||<|0.0001|TWO_SIDED|95.0|0.051|0.157|||Log Rank|||||0.157|0.051|<0.0001
71779960|NCT02319837|143059538|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.546|||<|0.0001|TWO_SIDED|95.0|0.427|0.699|||Log Rank|||||0.699|0.427|<0.0001
71779961|NCT02319837|143059538|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.619|||<|0.0001|TWO_SIDED|95.0|0.488|0.785|||Log Rank|||||0.785|0.488|<0.0001
71779962|NCT02319837|143059539|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|0.261||||0.0001|TWO_SIDED|95.0|0.125|0.548|||Log Rank|||||0.548|0.125|0.0001
71779963|NCT02319837|143059539|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|0.423||||0.0057|TWO_SIDED|95.0|0.226|0.794|||Log Rank|||||0.794|0.226|0.0057
71835033|NCT04878354|143174736|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.1516|TWO_SIDED|95.0|-0.11|0.76|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.76|-0.11|0.1516
71835034|NCT04878354|143174737|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9709|TWO_SIDED|95.0|-0.24|0.25|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.25|-0.24|0.9709
71835035|NCT04878354|143174738|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.0499|TWO_SIDED|95.0|0.0|0.41|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.41|0.00|0.0499
71835036|NCT04878354|143174739|SUPERIORITY||Median Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.73|2.18|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||2.18|0.73|<0.0001
71835037|NCT04878354|143174740|SUPERIORITY||Median Difference (Final Values)|0.48||||0.0075|TWO_SIDED|95.0|0.13|0.83|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.83|0.13|0.0075
71835038|NCT04878354|143174741|SUPERIORITY||Median Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.44|1.29|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||1.29|0.44|<0.0001
71891346|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0231|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|0.004|0.0231
71891347|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.013||0.1073|TWO_SIDED|95.0|-0.004|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.046|-0.004|0.1073
71747508|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.029|TWO_SIDED|95.0|0.008|0.141|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.141|0.008|0.029
71747509|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.055|0.188|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.188|0.055|<0.001
71747510|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.184|||<|0.001|TWO_SIDED|95.0|0.117|0.25|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.250|0.117|<0.001
71747511|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.142|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.142|<0.001
71747512|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.227|0.36|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.360|0.227|<0.001
71747513|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.161|TWO_SIDED|95.0|-0.019|0.113|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.113|-0.019|0.161
71747514|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.001|TWO_SIDED|95.0|0.043|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.043|0.001
71747515|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.068|0.201|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.201|0.068|<0.001
71747516|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.062||||0.066|TWO_SIDED|95.0|-0.004|0.128|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.004|0.066
71835039|NCT04878354|143174742|SUPERIORITY||Odds Ratio (OR)|1.2|||<|0.0001|TWO_SIDED|95.0|1.1|1.32|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.32|1.10|<0.0001
71835040|NCT04878354|143174743|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9124|TWO_SIDED|95.0|0.93|1.08|||Generalised linear mixed model (GLMM)||Odds ration is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a severe day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of severe days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||1.08|0.93|0.9124
71666508|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|15.0|STANDARD_ERROR_OF_MEAN|15.44||0.3337|TWO_SIDED|90.0|-10.62|40.59||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||40.59|-10.62|0.3337
71747517|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.01|TWO_SIDED|95.0|0.021|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|0.021|0.010
71835041|NCT04878354|143174744|SUPERIORITY||Odds Ratio (OR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.71|0.81|||Generalised linear fixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.81|0.71|<0.0001
71891348|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.083|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.058|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.058|<0.0001
71891349|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.013||0.0029|TWO_SIDED|95.0|0.013|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.013|0.0029
71891350|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6939|TWO_SIDED|95.0|-0.02|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.030|-0.020|0.6939
71891351|NCT01431287|143304549|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0097|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.058|0.008|0.0097
71891352|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.608|-2.778|0.0022
71891353|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.153|-2.313|0.0252
71891354|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.052|-2.113|0.0620
71747518|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.025||||0.465|TWO_SIDED|95.0|-0.042|0.091|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.042|0.465
71747519|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.112||||0.008|TWO_SIDED|95.0|0.03|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.030|0.008
71747520|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.173|||<|0.001|TWO_SIDED|95.0|0.091|0.256|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.256|0.091|<0.001
71747521|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.219|||<|0.001|TWO_SIDED|95.0|0.136|0.302|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.136|<0.001
71779964|NCT02319837|143059540|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.078||||0.4321|TWO_SIDED|95.0|0.894|1.301|||Log Rank|||||1.301|0.894|0.4321
71779965|NCT02319837|143059540|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.09||||0.3702|TWO_SIDED|95.0|0.904|1.314|||Log Rank|||||1.314|0.904|0.3702
71779966|NCT02319837|143059541|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.|Hazard Ratio (HR)|1.138||||0.1567|TWO_SIDED|95.0|0.954|1.357|||Log Rank|||||1.357|0.954|0.1567
71779967|NCT02319837|143059541|OTHER|Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.|Hazard Ratio (HR)|1.168||||0.0855|TWO_SIDED|95.0|0.981|1.391|||Log Rank|||||1.391|0.981|0.0855
71779968|NCT00494299|143059580|SUPERIORITY_OR_OTHER||Log Rank|0.2520462|||||||||||||The comparison between the 2 groups is done using the log rank test stratified by the response of TACE (Responder group A versus Responder group B), ECOG performance status (PS) (0 versus 1) and the number of prior TACE (1 versus 2).|||||
71747522|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.131|0.295|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.295|0.131|<0.001
71747523|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.326|||<|0.001|TWO_SIDED|95.0|0.244|0.409|||McNemar|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.409|0.244|<0.001
71747524|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.144|TWO_SIDED|95.0|-0.021|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.021|0.144
71779969|NCT00494299|143059580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8735||||||95.0|0.6972|1.0942|||||Hazard Ratio: Sorafenib/Placebo.|||1.0942|0.6972|
71779970|NCT01589978|143059591|NON_INFERIORITY_OR_EQUIVALENCE|Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.||||<.0001
71891355|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.618|-1.531|0.4051
71891356|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.507|-1.649|0.2988
71891357|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.407|-1.731|0.2249
71747525|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.107||||0.011|TWO_SIDED|95.0|0.024|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.024|0.011
71891358|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.042|-2.195|0.0418
71891359|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.633|-1.552|0.4097
71891360|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.515|-1.664|0.3013
71891361|NCT01431287|143304550|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||1.200|-0.970|0.8355
71891362|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.684|0.155|0.0019
71891363|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.619|0.092|0.0082
71747526|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.016|TWO_SIDED|95.0|0.019|0.182|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.182|0.019|0.016
71747527|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.28|TWO_SIDED|95.0|-0.037|0.128|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|-0.037|0.280
71747528|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.342|TWO_SIDED|95.0|-0.042|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|-0.042|0.342
71747529|NCT03084796|143003803|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.886|TWO_SIDED|95.0|-0.088|0.076|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.076|-0.088|0.886
71747530|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.097||||0.003|TWO_SIDED|95.0|0.032|0.163|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.163|0.032|0.003
71747531|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.156|||<|0.001|TWO_SIDED|95.0|0.091|0.221|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.221|0.091|<0.001
71747532|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.208|||<|0.001|TWO_SIDED|95.0|0.143|0.273|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.273|0.143|<0.001
71747533|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.237|||<|0.001|TWO_SIDED|95.0|0.172|0.302|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.302|0.172|<0.001
71747534|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.276|||<|0.001|TWO_SIDED|95.0|0.211|0.341|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.341|0.211|<0.001
71747535|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.076|TWO_SIDED|95.0|-0.006|0.124|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.124|-0.006|0.076
71666509|NCT04856917|142847586|SUPERIORITY||LS Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|15.48||0.0465|TWO_SIDED|90.0|5.5|56.87||LS Mean, SE, 90% CI, \& p-value was based on LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs 4) as categorical covariates \& baseline facial non-inflammatory lesion count as continuous covariate|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||56.87|5.50|0.0465
71779971|NCT01589978|143059611|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).||||<.0001
71779972|NCT02925117|143059634|SUPERIORITY||Least Squares (LS) Mean Difference|-51.4|STANDARD_ERROR_OF_MEAN|7.65|<|0.001|TWO_SIDED|95.0|-66.5|-36.3|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-36.3|-66.5|< 0.001
71779973|NCT02925117|143059634|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|95.0|-53.7|-23.6|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-23.6|-53.7|<0.001
71779974|NCT02925117|143059634|SUPERIORITY||LS Mean Difference|-16.4|STANDARD_ERROR_OF_MEAN|7.61||0.032|TWO_SIDED|95.0|-31.4|-1.4|||ANCOVA|Analysis of covariance (ANCOVA) with stratum (geographic region), baseline value, and treatment in the model.||||-1.4|-31.4|0.032
71779975|NCT02925117|143059635|SUPERIORITY||Adjusted Difference|58.7|||<|0.001|TWO_SIDED|95.0|42.5|74.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||74.8|42.5|< 0.001
71779976|NCT02925117|143059635|SUPERIORITY||Adjusted Difference|42.5|||<|0.001|TWO_SIDED|95.0|25.5|59.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||59.6|25.5|<0.001
71779977|NCT02925117|143059635|SUPERIORITY||Adjusted Difference|18.7||||0.022|TWO_SIDED|95.0|2.7|34.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||34.7|2.7|0.022
71779978|NCT02925117|143059636|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.1|62.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||62.7|31.1|<0.001
71779979|NCT02925117|143059636|SUPERIORITY||Adjusted Difference|28.6|||<|0.001|TWO_SIDED|95.0|13.8|43.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||43.4|13.8|<0.001
71779980|NCT02925117|143059636|SUPERIORITY||Adjusted Difference|11.9||||0.044|TWO_SIDED|95.0|0.3|23.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, adjusted for stratum (geographic region).||||23.5|0.3|0.044
71779981|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-59.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-72.3|-46.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-46.3|-72.3|<0.001
71779982|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-47.7|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-61.1|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-34.3|-61.1|<0.001
71779983|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|6.7|<|0.001|TWO_SIDED|95.0|-44.3|-17.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 2||-17.8|-44.3|<0.001
71666510|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.95||0.215|TWO_SIDED|90.0|-1.21|8.56||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||8.56|-1.21|0.2150
71779984|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|8.85|<|0.001|TWO_SIDED|95.0|-83.9|-48.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-48.9|-83.9|<0.001
71779985|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|9.13|<|0.001|TWO_SIDED|95.0|-56.4|-20.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-20.4|-56.4|<0.001
71779986|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-28.9|STANDARD_ERROR_OF_MEAN|8.96||0.002|TWO_SIDED|95.0|-46.6|-11.2|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 8||-11.2|-46.6|0.002
71779987|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|9.78|<|0.001|TWO_SIDED|95.0|-78.6|-39.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-39.9|-78.6|<0.001
71779988|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-38.3|STANDARD_ERROR_OF_MEAN|10.08|<|0.001|TWO_SIDED|95.0|-58.3|-18.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-18.4|-58.3|<0.001
71779989|NCT02925117|143059637|SUPERIORITY||LS Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.9||0.003|TWO_SIDED|95.0|-49.4|-10.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in Pruritus NRS at Week 16||-10.3|-49.4|0.003
71779990|NCT02925117|143059638|SUPERIORITY||LS Mean Difference|-65.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.001|TWO_SIDED|95.0|-80.0|-50.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-50.5|-80.0|<0.001
71835042|NCT04878354|143174745|SUPERIORITY||Odds Ratio (OR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.85|0.93|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a well day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of well days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.93|0.85|<0.0001
71835043|NCT04878354|143174746|SUPERIORITY||Odds Ratio (OR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.72|0.84|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.84|0.72|<0.0001
71666511|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.97||0.0864|TWO_SIDED|90.0|0.21|10.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||10.05|0.21|0.0864
71666512|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|3.88||0.0084|TWO_SIDED|90.0|3.97|16.85||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||16.85|3.97|0.0084
71666513|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|3.91||0.16|TWO_SIDED|90.0|-0.95|12.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||12.01|-0.95|0.1600
71747536|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.111|||<|0.001|TWO_SIDED|95.0|0.046|0.176|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.176|0.046|<0.001
71747537|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.075|0.205|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.205|0.075|<0.001
71747538|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.116|TWO_SIDED|95.0|-0.013|0.117|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.117|-0.013|0.116
71666514|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.23||0.3671|TWO_SIDED|90.0|-3.94|13.41||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||13.41|-3.94|0.3671
71666515|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.35||0.1587|TWO_SIDED|90.0|-1.28|16.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||16.46|-1.28|0.1587
71747539|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.081||||0.014|TWO_SIDED|95.0|0.016|0.146|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.146|0.016|0.014
71779991|NCT02925117|143059638|SUPERIORITY||LS Mean Difference|-47.9|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-62.6|-33.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-33.3|-62.6|<0.001
71779992|NCT02925117|143059638|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|7.42|<|0.001|TWO_SIDED|95.0|-40.8|-11.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-11.5|-40.8|<0.001
71779993|NCT02925117|143059639|SUPERIORITY||LS Mean Difference|-58.3|STANDARD_ERROR_OF_MEAN|6.78|<|0.001|TWO_SIDED|95.0|-71.7|-44.9|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-44.9|-71.7|<0.001
71779994|NCT02925117|143059639|SUPERIORITY||LS Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|6.94|<|0.001|TWO_SIDED|95.0|-50.8|-23.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-23.4|-50.8|<0.001
71779995|NCT02925117|143059639|SUPERIORITY||LS Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|6.81|<|0.001|TWO_SIDED|95.0|-41.9|-15.0|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 8||-15.0|-41.9|<0.001
71779996|NCT02925117|143059639|SUPERIORITY||LS Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|6.93|<|0.001|TWO_SIDED|95.0|-61.7|-34.3|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-34.3|-61.7|<0.001
71779997|NCT02925117|143059639|SUPERIORITY||LS Mean Difference|-34.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-48.5|-20.5|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-20.5|-48.5|<0.001
71666516|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.8||0.1932|TWO_SIDED|90.0|-2.03|17.21||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||17.21|-2.03|0.1932
71666517|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.82||0.2518|TWO_SIDED|90.0|-2.95|16.37||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||16.37|-2.95|0.2518
71666518|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|5.53||0.232|TWO_SIDED|90.0|-2.53|15.83||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||15.83|-2.53|0.2320
71666519|NCT04856917|142847587|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.55||0.2014|TWO_SIDED|90.0|-2.08|16.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||16.35|-2.08|0.2014
71747540|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.029||||0.384|TWO_SIDED|95.0|-0.036|0.094|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.094|-0.036|0.384
71747541|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.064|0.236|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.236|0.064|<0.001
71666520|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|4.94||0.4361|TWO_SIDED|90.0|-4.34|12.06||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||12.06|-4.34|0.4361
71747542|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.118|0.29|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.290|0.118|<0.001
71779998|NCT02925117|143059639|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|6.96||0.004|TWO_SIDED|95.0|-33.9|-6.4|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||Analysis of Percent Change from Baseline in SCORAD at Week 16||-6.4|-33.9|0.004
71779999|NCT02925117|143059640|SUPERIORITY||Adjusted Difference|72.7|||<|0.001|TWO_SIDED|95.0|58.3|87.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||87.1|58.3|<0.001
71780000|NCT02925117|143059640|SUPERIORITY||Adjusted Difference|44.9|||<|0.001|TWO_SIDED|95.0|27.9|61.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||61.9|27.9|<0.001
71780001|NCT02925117|143059640|SUPERIORITY||Adjusted Difference|23.4||||0.004|TWO_SIDED|95.0|7.5|39.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||39.4|7.5|0.004
71780002|NCT02925117|143059641|SUPERIORITY||Adjusted Difference|70.7|||<|0.001|TWO_SIDED|95.0|56.2|85.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||85.2|56.2|<0.001
71780003|NCT02925117|143059641|SUPERIORITY||Adjusted Difference|49.0|||<|0.001|TWO_SIDED|95.0|30.8|67.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||67.3|30.8|<0.001
71780004|NCT02925117|143059641|SUPERIORITY||Adjusted Difference|32.8|||<|0.001|TWO_SIDED|95.0|13.4|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 8||52.2|13.4|<0.001
71780005|NCT02925117|143059641|SUPERIORITY||Adjusted Difference|60.6|||<|0.001|TWO_SIDED|95.0|45.3|75.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||75.9|45.3|<0.001
71780006|NCT02925117|143059641|SUPERIORITY||Adjusted Difference|48.6|||<|0.001|TWO_SIDED|95.0|31.3|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||65.9|31.3|<0.001
71780007|NCT02925117|143059641|SUPERIORITY||Adjusted Difference|28.2||||0.003|TWO_SIDED|95.0|9.8|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 50 Response at Week 16||46.6|9.8|0.003
71780008|NCT02925117|143059642|SUPERIORITY||Adjusted Difference|43.8|||<|0.001|TWO_SIDED|95.0|29.1|58.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||58.5|29.1|<0.001
71780009|NCT02925117|143059642|SUPERIORITY||Adjusted Difference|26.1|||<|0.001|TWO_SIDED|95.0|12.6|39.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||39.6|12.6|<0.001
71780010|NCT02925117|143059642|SUPERIORITY||Adjusted Difference|9.4||||0.051|TWO_SIDED|95.0|0.0|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 8||18.8|-0.0|0.051
71780011|NCT02925117|143059642|SUPERIORITY||Adjusted Difference|46.9|||<|0.001|TWO_SIDED|95.0|31.3|62.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||62.4|31.3|<0.001
71747543|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.248|||<|0.001|TWO_SIDED|95.0|0.162|0.335|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.335|0.162|<0.001
71747544|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.254|||<|0.001|TWO_SIDED|95.0|0.168|0.339|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.339|0.168|<0.001
71747545|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.354|||<|0.001|TWO_SIDED|95.0|0.268|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.268|<0.001
71747546|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.054||||0.214|TWO_SIDED|95.0|-0.031|0.14|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.140|-0.031|0.214
71835044|NCT04878354|143174747|SUPERIORITY||Odds Ratio (OR)|0.9||||0.0001|TWO_SIDED|95.0|0.86|0.95|||Generalised linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet / odds tree SLIT-tablet)|The odds of having a symptom-free day was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model includes proportion of symptom-free days as the response variable and treatment, cohort, and age group as fixed effects and pollen station as random effect. Observed p-value.||0.95|0.86|0.0001
71835045|NCT04878354|143174750|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0015|TWO_SIDED|95.0|0.07|0.29|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in an LME model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.29|0.07|0.0015
71835046|NCT04878354|143174751|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0032|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The square root transformed endpoint was analysed in a linear mixed effects (LME) model with treatment, cohort, and age group as fixed effects, and pollen station within cohort as a random effect with different residual errors specified for each treatment group. Back-transformation was used to estimate the absolute difference. Observed p-value.||0.20|0.04|0.0032
71835047|NCT04878354|143174752|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9277|TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effects (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.23|-0.21|0.9277
71835048|NCT04878354|143174753|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9643|TWO_SIDED|95.0|-0.19|0.18|||Mixed Models Analysis||Placebo SLIT-tablet vs tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.18|-0.19|0.9643
71835049|NCT04878354|143174754|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.0287|TWO_SIDED|95.0|0.02|0.34|||Mixed Models Analysis||Placebo SLIT-tablet vs. tree SLIT-tablet|Multiple imputation was used to impute missing data under the hypothetical strategy. The endpoint was analysed in each dataset in a linear mixed effect (LME) model with treatment and cohort as fixed effects, and pollen station within cohort as a random effect. Each treatment group was allowed different residual errors. Observed p-value.||0.34|0.02|0.0287
71891364|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.681|0.152|0.0020
71835050|NCT04878354|143174756|SUPERIORITY||Odds Ratio (OR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.3|0.58|||Generalized linear mixed model (GLMM)||Odds ratio is (odds placebo SLIT-tablet/ odds tree SLIT-tablet)|"Multiple imputation was used to impute missing data under the hypothetical strategy.~The odds of having an improved treatment efficacy according to patient-rated global evaluation was analysed using a generalised linear mixed model with a logit link function. The model includes patient-rated global evaluation of treatment efficacy (improvement/no improvement) as the response variable and treatment, cohort and age group as fixed effects and pollen station as random effects. Observed p-value."||0.58|0.30|<0.0001
71891365|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.554|0.027|0.0307
71747547|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.098||||0.025|TWO_SIDED|95.0|0.012|0.184|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|0.012|0.025
71747548|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.104||||0.016|TWO_SIDED|95.0|0.019|0.189|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.189|0.019|0.016
71666521|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|8.2|STANDARD_ERROR_OF_MEAN|4.98||0.1018|TWO_SIDED|90.0|-0.04|16.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||16.48|-0.04|0.1018
71666522|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|16.3|STANDARD_ERROR_OF_MEAN|5.79||0.0059|TWO_SIDED|90.0|6.66|25.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||25.88|6.66|0.0059
71835051|NCT04878354|143174757|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|TWO_SIDED|95.0|0.38|0.48|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.48|0.38|<0.0001
71666523|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|9.9|STANDARD_ERROR_OF_MEAN|5.83||0.0913|TWO_SIDED|90.0|0.26|19.59||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||19.59|0.26|0.0913
71835052|NCT04878354|143174757|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.1038|TWO_SIDED|95.0|-0.09|0.01|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.01|-0.09|0.1038
71747549|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.313|TWO_SIDED|95.0|-0.042|0.13|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.130|-0.042|0.313
71747550|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.25|TWO_SIDED|95.0|-0.035|0.135|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.135|-0.035|0.250
71747551|NCT03084796|143003804|SUPERIORITY||Mean Difference (Final Values)|0.006||||0.898|TWO_SIDED|95.0|-0.08|0.091|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.091|-0.080|0.898
71747552|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.006|0.153|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.153|0.006|0.035
71747553|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.158|||<|0.001|TWO_SIDED|95.0|0.085|0.232|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.085|<0.001
71747554|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.201|||<|0.001|TWO_SIDED|95.0|0.127|0.275|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.275|0.127|<0.001
71747555|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.241|||<|0.001|TWO_SIDED|95.0|0.168|0.315|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.315|0.168|<0.001
71747556|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.277|||<|0.001|TWO_SIDED|95.0|0.204|0.351|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.351|0.204|<0.001
71747557|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.035|TWO_SIDED|95.0|0.005|0.152|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.152|0.005|0.035
71747558|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.121||||0.001|TWO_SIDED|95.0|0.048|0.195|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.048|0.001
71747559|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.162|||<|0.001|TWO_SIDED|95.0|0.088|0.235|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.235|0.088|<0.001
71747560|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.256|TWO_SIDED|95.0|-0.031|0.116|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.116|-0.031|0.256
71666524|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|7.7||0.4921|TWO_SIDED|90.0|-7.47|18.09||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||18.09|-7.47|0.4921
71666525|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|7.89||0.1607|TWO_SIDED|90.0|-1.95|24.24||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||24.24|-1.95|0.1607
71666526|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|9.19||0.1244|TWO_SIDED|90.0|-1.02|29.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||29.48|-1.02|0.1244
71666527|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|15.2|STANDARD_ERROR_OF_MEAN|9.2||0.1004|TWO_SIDED|90.0|-0.02|30.51||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||30.51|-0.02|0.1004
71666528|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|12.4|STANDARD_ERROR_OF_MEAN|9.64||0.2015|TWO_SIDED|90.0|-3.61|28.39||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||28.39|-3.61|0.2015
71666529|NCT04856917|142847588|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|9.66||0.1057|TWO_SIDED|90.0|-0.27|31.81||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline total facial lesion count as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||31.81|-0.27|0.1057
71666530|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.08||0.5157|TWO_SIDED|90.0|-0.08|0.19||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||0.19|-0.08|0.5157
71666531|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0178|TWO_SIDED|90.0|0.06|0.34||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||0.34|0.06|0.0178
71666532|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.3|STANDARD_DEVIATION|0.12||0.0132|TWO_SIDED|90.0|0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||0.48|0.10|0.0132
71666533|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0034|TWO_SIDED|90.0|0.16|0.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||0.54|0.16|0.0034
71747561|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.083||||0.027|TWO_SIDED|95.0|0.01|0.156|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.156|0.010|0.027
71666534|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.051|TWO_SIDED|90.0|0.04|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||0.47|0.04|0.0510
71666535|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0608|TWO_SIDED|90.0|0.03|0.47||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||0.47|0.03|0.0608
71747562|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.281|TWO_SIDED|95.0|-0.033|0.114|||Mixed Models Analysis|||"Day 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.114|-0.033|0.281
71747563|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.141||||0.003|TWO_SIDED|95.0|0.05|0.232|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.232|0.050|0.003
71747564|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.197|||<|0.001|TWO_SIDED|95.0|0.106|0.288|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.288|0.106|<0.001
71747565|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.249|||<|0.001|TWO_SIDED|95.0|0.157|0.34|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.340|0.157|<0.001
71666536|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2702|TWO_SIDED|90.0|-0.1|0.48||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||0.48|-0.10|0.2702
71747566|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.245|||<|0.001|TWO_SIDED|95.0|0.155|0.336|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.336|0.155|<0.001
71747567|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.348|||<|0.001|TWO_SIDED|95.0|0.258|0.439|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.439|0.258|<0.001
71666537|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0249|TWO_SIDED|90.0|0.11|0.69||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||0.69|0.11|0.0249
71747568|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.056||||0.222|TWO_SIDED|95.0|-0.034|0.147|||Mixed Models Analysis|||"week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.147|-0.034|0.222
71747569|NCT03084796|143003805|SUPERIORITY||Hazard Ratio, log|0.108||||0.02|TWO_SIDED|95.0|0.017|0.199|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.199|0.017|0.020
71747570|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.022|TWO_SIDED|95.0|0.015|0.195|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.195|0.015|0.022
71747571|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.262|TWO_SIDED|95.0|-0.039|0.143|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.143|-0.039|0.262
71747572|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|0.048||||0.29|TWO_SIDED|95.0|-0.041|0.138|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.041|0.290
71747573|NCT03084796|143003805|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.938|TWO_SIDED|95.0|-0.094|0.087|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.087|-0.094|0.938
71747574|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.64||||0.002|TWO_SIDED|95.0|1.21|2.24|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using Cox proportional hazards model, including treatment, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and baseline FEV1 value as covariate."||2.24|1.21|0.002
71747575|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|2.18|||<|0.001|TWO_SIDED|95.0|1.61|2.94|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.94|1.61|<0.001
71747576|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|2.79|||<|0.001|TWO_SIDED|95.0|2.07|3.78|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.78|2.07|<0.001
71747577|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|3.07|||<|0.001|TWO_SIDED|95.0|2.27|4.15|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.15|2.27|<0.001
71747578|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.17|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.17|2.30|<0.001
71747579|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.052|TWO_SIDED|95.0|1.0|1.76|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.76|1.00|0.052
71747580|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.26|1.28|<0.001
71747581|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.87|||<|0.001|TWO_SIDED|95.0|1.41|2.48|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.48|1.41|<0.001
71780012|NCT02925117|143059642|SUPERIORITY||Adjusted Difference|23.8||||0.001|TWO_SIDED|95.0|9.6|38.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||38.1|9.6|0.001
71666538|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1853|TWO_SIDED|90.0|-0.06|0.55||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||0.55|-0.06|0.1853
71666539|NCT04856917|142847589|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2974|TWO_SIDED|90.0|-0.11|0.5||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline facial IGA as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||0.50|-0.11|0.2974
71666540|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-2.5||||0.339|TWO_SIDED|90.0|-6.62|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.63|-6.62|0.3390
71666541|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-2.6||||0.3243|TWO_SIDED|90.0|-6.79|1.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.59|-6.79|0.3243
71666542|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-5.91|5.91||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 8||5.91|-5.91|1.0000
71666543|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-2.66||||0.332|TWO_SIDED|90.0|-6.96|1.63||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 8||1.63|-6.96|0.3320
71666544|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-2.45||||0.7595|TWO_SIDED|90.0|-15.5|10.59||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 12||10.59|-15.50|0.7595
71666545|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-14.11||||0.0209|TWO_SIDED|90.0|-23.66|-4.57||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 12||-4.57|-23.66|0.0209
71747582|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.074|TWO_SIDED|95.0|0.98|1.69|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.69|0.98|0.074
71747583|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.013|TWO_SIDED|95.0|1.08|1.85|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.85|1.08|0.013
71747584|NCT03084796|143003806|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.494|TWO_SIDED|95.0|0.84|1.44|||Regression, Cox|||"Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.44|0.84|0.494
71747585|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.017|TWO_SIDED|95.0|0.011|0.107|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.107|0.011|0.017
71747586|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.001|TWO_SIDED|95.0|0.032|0.128|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.128|0.032|0.001
71666546|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-4.56||||0.6094|TWO_SIDED|90.0|-18.99|9.87||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 400/200 mg vs Placebo: Week 20||9.87|-18.99|0.6094
71666547|NCT04856917|142847590|SUPERIORITY||Risk Difference (RD)|-10.28||||0.2076|TWO_SIDED|90.0|-23.34|2.78||P-value for the adjusted risk difference between imsidolimab and placebo was obtained from generalized Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA score at baseline.|Cochran-Mantel-Haenszel|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.78|-23.34|0.2076
71747587|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
71747588|NCT03084796|143003808|SUPERIORITY||Hazard Ratio, log|0.111|||<|0.001|TWO_SIDED|95.0|0.063|0.159|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.159|0.063|<0.001
71747589|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.122|||<|0.001|TWO_SIDED|95.0|0.074|0.17|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.170|0.074|<0.001
71780013|NCT02925117|143059642|SUPERIORITY||Adjusted Difference|11.8||||0.049|TWO_SIDED|95.0|0.1|23.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of EASI 90 Response at Week 16||23.6|0.1|0.049
71747590|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.377|TWO_SIDED|95.0|-0.026|0.069|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.069|-0.026|0.377
71780014|NCT02925117|143059643|SUPERIORITY||Adjusted Difference|68.4|||<|0.001|TWO_SIDED|95.0|54.0|82.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||82.8|54.0|<0.001
71780015|NCT02925117|143059643|SUPERIORITY||Adjusted Difference|35.3|||<|0.001|TWO_SIDED|95.0|18.5|52.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||52.2|18.5|<0.001
71747591|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.01|TWO_SIDED|95.0|0.015|0.111|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.111|0.015|0.010
71747592|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.031|TWO_SIDED|95.0|0.005|0.1|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.100|0.005|0.031
71747593|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.085|TWO_SIDED|95.0|-0.006|0.089|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.089|-0.006|0.085
71747594|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.199|TWO_SIDED|95.0|-0.016|0.079|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.079|-0.016|0.199
71747595|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|-0.011||||0.657|TWO_SIDED|95.0|-0.058|0.037|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.037|-0.058|0.657
71747596|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.246|TWO_SIDED|95.0|-0.022|0.086|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.086|-0.022|0.246
71747597|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.1|||<|0.001|TWO_SIDED|95.0|0.046|0.154|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.154|0.046|<0.001
71780016|NCT02925117|143059643|SUPERIORITY||Adjusted Difference|25.7||||0.002|TWO_SIDED|95.0|9.6|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 8||41.7|9.6|0.002
71835053|NCT04878354|143174758|SUPERIORITY||Mean Difference (Final Values)|0.53|||<|0.0001|TWO_SIDED|95.0|0.48|0.57|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.57|0.48|<0.0001
71780017|NCT02925117|143059643|SUPERIORITY||Adjusted Difference|54.5|||<|0.001|TWO_SIDED|95.0|39.0|69.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||69.9|39.0|<0.001
71780018|NCT02925117|143059643|SUPERIORITY||Adjusted Difference|35.8|||<|0.001|TWO_SIDED|95.0|19.1|52.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||52.5|19.1|<0.001
71666548|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|0.1||||0.4482|TWO_SIDED|90.0|-0.1|0.29||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.29|-0.10|0.4482
71747598|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.119|||<|0.001|TWO_SIDED|95.0|0.064|0.173|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.173|0.064|<0.001
71747599|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.088|0.196|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.196|0.088|<0.001
71747600|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.07|0.178|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.178|0.070|<0.001
71747601|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.068||||0.014|TWO_SIDED|95.0|0.014|0.121|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.121|0.014|0.014
71747602|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.002|TWO_SIDED|95.0|0.032|0.141|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.141|0.032|0.002
71747603|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.163|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.163|0.057|<0.001
71780019|NCT02925117|143059643|SUPERIORITY||Adjusted Difference|21.2||||0.008|TWO_SIDED|95.0|5.7|36.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 50 Response at Week 16||36.8|5.7|0.008
71780020|NCT02925117|143059644|SUPERIORITY||Adjusted Difference|30.4|||<|0.001|TWO_SIDED|95.0|16.2|44.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||44.6|16.2|<0.001
71780021|NCT02925117|143059644|SUPERIORITY||Adjusted Difference|9.4||||0.052|TWO_SIDED|95.0|-0.1|18.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.9|-0.1|0.052
71780022|NCT02925117|143059644|SUPERIORITY||Adjusted Difference|9.3||||0.048|TWO_SIDED|95.0|0.1|18.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 8||18.5|0.1|0.048
71835054|NCT04878354|143174758|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.0001|TWO_SIDED|95.0|0.45|0.53|||Mixed Models Analysis||Tree SLIT-tablet vs placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.53|0.45|<0.0001
71835055|NCT04878354|143174759|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.24|0.33|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 4|Change from baseline (screening) to visit 4 (pre-TPS). Change from baseline of log transformed concentrations is analyzed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.33|0.24|<0.0001
71780023|NCT02925117|143059644|SUPERIORITY||Adjusted Difference|37.7|||<|0.001|TWO_SIDED|95.0|22.2|53.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||53.3|22.2|<0.001
71780024|NCT02925117|143059644|SUPERIORITY||Adjusted Difference|19.0||||0.006|TWO_SIDED|95.0|5.6|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||32.5|5.6|0.006
71780025|NCT02925117|143059644|SUPERIORITY||Adjusted Difference|2.4||||0.581|TWO_SIDED|95.0|-6.0|10.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 75 Response at Week 16||10.8|-6.0|0.581
71780026|NCT02925117|143059645|SUPERIORITY||Adjusted Difference|14.2||||0.012|TWO_SIDED|95.0|3.2|25.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||25.2|3.2|0.012
71780027|NCT02925117|143059645|SUPERIORITY||Adjusted Difference|2.3||||0.428|TWO_SIDED|95.0|-3.4|8.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||8.0|-3.4|0.428
71780028|NCT02925117|143059645|SUPERIORITY||Adjusted Difference|4.6||||0.206|TWO_SIDED|95.0|-2.5|11.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 8||11.8|-2.5|0.206
71780029|NCT02925117|143059645|SUPERIORITY||Adjusted Difference|23.3|||<|0.001|TWO_SIDED|95.0|10.4|36.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||36.2|10.4|<0.001
71780030|NCT02925117|143059645|SUPERIORITY||Adjusted Difference|9.4||||0.048|TWO_SIDED|95.0|0.1|18.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||18.8|0.1|0.048
71666549|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|0.14||||0.4529|TWO_SIDED|90.0|-0.05|0.33||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.33|-0.05|0.4529
71666550|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.01||||0.932|TWO_SIDED|90.0|-0.2|0.18||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.18|-0.20|0.9320
71747604|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.493|TWO_SIDED|95.0|-0.035|0.073|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.073|-0.035|0.493
71747605|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.042||||0.119|TWO_SIDED|95.0|-0.011|0.096|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.096|-0.011|0.119
71747606|NCT03084796|143003808|SUPERIORITY||Mean Difference (Final Values)|0.023||||0.392|TWO_SIDED|95.0|-0.03|0.077|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.030|0.392
71747607|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.109||||0.023|TWO_SIDED|95.0|0.015|0.203|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model for repeated measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by visit interaction as covariates."||0.203|0.015|0.023
71747608|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.058|TWO_SIDED|95.0|-0.003|0.184|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.184|-0.003|0.058
71747609|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.059||||0.215|TWO_SIDED|95.0|-0.035|0.153|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.153|-0.035|0.215
71747610|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.051|TWO_SIDED|95.0|-0.001|0.187|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.187|-0.001|0.051
71747611|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.364|TWO_SIDED|95.0|-0.051|0.138|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.138|-0.051|0.364
71747612|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.694|TWO_SIDED|95.0|-0.112|0.074|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.074|-0.112|0.694
71747613|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.297|TWO_SIDED|95.0|-0.143|0.044|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.044|-0.143|0.297
71747614|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|-0.016||||0.734|TWO_SIDED|95.0|-0.109|0.077|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.077|-0.109|0.734
71747615|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.514|TWO_SIDED|95.0|-0.124|0.062|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.062|-0.124|0.514
71747616|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.003||||0.957|TWO_SIDED|95.0|-0.09|0.095|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.095|-0.090|0.957
71891366|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.616|0.089|0.0088
71666551|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.03||||0.3151|TWO_SIDED|90.0|-0.22|0.16||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 4||0.16|-0.22|0.3151
71666552|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.14||||0.2908|TWO_SIDED|90.0|-0.32|0.06||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.06|-0.32|0.2908
71747617|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.479|TWO_SIDED|95.0|-0.06|0.127|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.127|-0.060|0.479
71747618|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.687|TWO_SIDED|95.0|-0.079|0.12|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.120|-0.079|0.687
71747619|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.066||||0.195|TWO_SIDED|95.0|-0.034|0.165|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.165|-0.034|0.195
71780031|NCT02925117|143059645|SUPERIORITY||Adjusted Difference|2.4||||0.426|TWO_SIDED|95.0|-3.4|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||Analysis of SCORAD 90 Response at Week 16||8.1|-3.4|0.426
71780032|NCT02925117|143059651|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-34.9|-18.1|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-18.1|-34.9|<0.001
71780033|NCT02925117|143059651|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-31.4|-14.6|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||-14.6|-31.4|<0.001
71780034|NCT02925117|143059651|SUPERIORITY||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.25||0.075|TWO_SIDED|95.0|-16.0|0.8|||ANCOVA|ANCOVA with stratum (geographic region), baseline value, and treatment in the model.||||0.8|-16.0|0.075
71780035|NCT02925117|143059652|SUPERIORITY||Adjusted Difference|47.4|||<|0.001|TWO_SIDED|95.0|29.6|65.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||65.2|29.6|<0.001
71780036|NCT02925117|143059652|SUPERIORITY||Adjusted Difference|53.4|||<|0.001|TWO_SIDED|95.0|35.5|71.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||71.3|35.5|<0.001
71747620|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.111||||0.03|TWO_SIDED|95.0|0.011|0.212|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.212|0.011|0.030
71780037|NCT02925117|143059652|SUPERIORITY||Adjusted Difference|18.6||||0.021|TWO_SIDED|95.0|2.8|34.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (geographic region).||||34.3|2.8|0.021
71780038|NCT01681472|143059674|SUPERIORITY|||||||0.0323|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0323
71780039|NCT01681472|143059674|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
71780040|NCT01681472|143059674|SUPERIORITY|||||||0.8622|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8622
71780041|NCT01681472|143059674|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71780042|NCT01681472|143059674|SUPERIORITY|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0074
71780043|NCT01681472|143059674|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
71780044|NCT01681472|143059675|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1480
71780045|NCT01681472|143059675|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
71780046|NCT01681472|143059675|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
71780047|NCT01681472|143059675|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
71780048|NCT01681472|143059675|SUPERIORITY|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0019
71835056|NCT04878354|143174759|SUPERIORITY||Mean Difference (Final Values)|0.31|||<|0.0001|TWO_SIDED|95.0|0.26|0.36|||Mixed Models Analysis||Tree SLIT-tablet vs. placebo SLIT-tablet, visit 6|Change from baseline (screening) to visit 6 (end of treatment). Change from baseline of log transformed concentrations is analysed in a mixed effects linear model including treatment, visit, and treatment-visit-interaction as fixed effects, log(baseline concentration) as a covariate and subject as random effect. Observed p-value.||0.36|0.26|<0.0001
71835057|NCT02721381|143174767|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
71747621|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.112|TWO_SIDED|95.0|-0.019|0.179|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.179|-0.019|0.112
71747622|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.147|TWO_SIDED|95.0|-0.026|0.174|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.174|-0.026|0.147
71747623|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.37|TWO_SIDED|95.0|-0.054|0.144|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.144|-0.054|0.370
71747624|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.074|TWO_SIDED|95.0|-0.009|0.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.190|-0.009|0.074
71747625|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.233|TWO_SIDED|95.0|-0.039|0.158|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.158|-0.039|0.233
71747626|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.046||||0.369|TWO_SIDED|95.0|-0.054|0.145|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.145|-0.054|0.369
71747627|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|0.014||||0.773|TWO_SIDED|95.0|-0.084|0.112|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.112|-0.084|0.773
71747628|NCT03084796|143003809|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.536|TWO_SIDED|95.0|-0.13|0.068|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.068|-0.130|0.536
71747629|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.05||||0.848|TWO_SIDED|95.0|0.62|1.77|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||1.77|0.62|0.848
71747630|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.35||||0.264|TWO_SIDED|95.0|0.8|2.28|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.28|0.80|0.264
71747631|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.29||||0.343|TWO_SIDED|95.0|0.76|2.18|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.76|0.343
71747632|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.98|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.98|1.02|0.042
71835058|NCT02721381|143174768|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||<.001
71835059|NCT02721381|143174769|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
71835060|NCT02721381|143174770|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.85
71835061|NCT02721381|143174771|SUPERIORITY|||||||0.98|||||||ANCOVA|||||||.98
71747633|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.2||||0.503|TWO_SIDED|95.0|0.71|2.02|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.02|0.71|0.503
71835062|NCT02721381|143174772|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||.69
71666553|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|0.05||||0.7277|TWO_SIDED|90.0|-0.15|0.24||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||0.24|-0.15|0.7277
71747634|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.28||||0.354|TWO_SIDED|95.0|0.76|2.16|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.16|0.76|0.354
71747635|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.22||||0.447|TWO_SIDED|95.0|0.73|2.07|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.07|0.73|0.447
71835063|NCT02721381|143174773|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.038
71835064|NCT02721381|143174774|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||The effect of group assignment was examined using MLM, with a significant time X group interaction indicative of an effect of group assignment. Data from T1, T2, and T3 were both used in same analysis.||||.45
71747636|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.66||||0.064|TWO_SIDED|95.0|0.97|2.83|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.83|0.97|0.064
71747637|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|0.96||||0.867|TWO_SIDED|95.0|0.57|1.62|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.62|0.57|0.867
71747638|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.29||||0.347|TWO_SIDED|95.0|0.76|2.22|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.22|0.76|0.347
71747639|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.35||||0.269|TWO_SIDED|95.0|0.79|2.32|||Regression, Logistic|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.32|0.79|0.269
71747640|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.92||||0.018|TWO_SIDED|95.0|1.12|3.3|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure.~Analysis based on logistic regression model - multiple logistic regression model, with treatment, US regions, smoking status at screening, and BDI as covariates."||3.30|1.12|0.018
71747641|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.5|4.49|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.49|1.50|<0.001
71747642|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.75|5.44|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.44|1.75|<0.001
71747643|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.94|6.02|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.02|1.94|<0.001
71747644|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|2.45||||0.001|TWO_SIDED|95.0|1.41|4.26|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||4.26|1.41|0.001
71747645|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.35||||0.284|TWO_SIDED|95.0|0.78|2.35|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.35|0.78|0.284
71747646|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.61||||0.103|TWO_SIDED|95.0|0.91|2.84|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.84|0.91|0.103
71747647|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.78||||0.045|TWO_SIDED|95.0|1.01|3.14|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||3.14|1.01|0.045
71835065|NCT02721381|143174775|SUPERIORITY|||||||0.92|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.92
71835066|NCT02721381|143174776|SUPERIORITY|||||||0.42|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.42
71835067|NCT02721381|143174777|SUPERIORITY|||||||0.65|||||||ANCOVA|||ANCOVA controlling for T1 measure||||.65
71835068|NCT02721381|143174778|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Independent samples t-test||||.001
71835069|NCT05687903|143174785|SUPERIORITY||Estimate of LS Mean Difference|13.65|STANDARD_ERROR_OF_MEAN|2.983|=|0.001|TWO_SIDED|95.0|7.74|19.57||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||19.57|7.74|=0.001
71747648|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.19||||0.557|TWO_SIDED|95.0|0.67|2.12|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.12|0.67|0.557
71666554|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.03||||0.8463|TWO_SIDED|90.0|-0.23|0.17||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.17|-0.23|0.8463
71747649|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.32||||0.345|TWO_SIDED|95.0|0.74|2.34|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.34|0.74|0.345
71747650|NCT03084796|143003810|SUPERIORITY||Odds Ratio (OR)|1.11||||0.732|TWO_SIDED|95.0|0.61|2.0|||Regression, Logistic|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.00|0.61|0.732
71747651|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.666|TWO_SIDED|95.0|-0.52|0.81|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, visit, treatment by visit interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the BDI, BDI by visit interaction as covariates."||0.81|-0.52|0.666
71747652|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.224|TWO_SIDED|95.0|-0.25|1.07|||Mixed Models Analysis|||"week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.07|-0.25|0.224
71747653|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.239|TWO_SIDED|95.0|-0.27|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.27|0.239
71747654|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.019|TWO_SIDED|95.0|0.13|1.46|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.46|0.13|0.019
71747655|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.124|TWO_SIDED|95.0|-0.14|1.19|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.14|0.124
71747656|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.432|TWO_SIDED|95.0|-0.39|0.92|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.92|-0.39|0.432
71780049|NCT01681472|143059675|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6R\]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
71780050|NCT01681472|143059676|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
71780051|NCT01681472|143059676|SUPERIORITY|||||||0.0538|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0538
71747657|NCT03084796|143003811|SUPERIORITY||Mean Difference (Net)|0.25||||0.454|TWO_SIDED|95.0|-0.41|0.91|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.91|-0.41|0.454
71747658|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.053|TWO_SIDED|95.0|-0.01|1.31|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.31|-0.01|0.053
71747659|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.973|TWO_SIDED|95.0|-0.67|0.65|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.65|-0.67|0.973
71747660|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.247|TWO_SIDED|95.0|-0.27|1.04|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.04|-0.27|0.247
71780052|NCT01681472|143059676|SUPERIORITY|||||||0.5244|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5244
71780053|NCT01681472|143059676|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
71747661|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 3~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
71747662|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.071|TWO_SIDED|95.0|-0.05|1.28|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.28|-0.05|0.071
71747663|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.98||||0.004|TWO_SIDED|95.0|0.32|1.64|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.64|0.32|0.004
71747664|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|1.01||||0.003|TWO_SIDED|95.0|0.35|1.68|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.68|0.35|0.003
71835070|NCT05687903|143174785|SUPERIORITY||Estimate of LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|2.921|<|0.001|TWO_SIDED|95.0|18.87|30.46||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||30.46|18.87|<0.001
71835071|NCT05687903|143174785|SUPERIORITY||Estimate of LS Mean Difference|26.58|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|20.81|32.35||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||32.35|20.81|<0.001
71835072|NCT05687903|143174785|SUPERIORITY||Estimate of LS Mean Difference|16.13|STANDARD_ERROR_OF_MEAN|2.842|<|0.001|TWO_SIDED|95.0|10.49|21.76||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||21.76|10.49|<0.001
71835073|NCT05687903|143174786|SUPERIORITY||Estimate of LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|1.564|=|0.004|TWO_SIDED|95.0|-9.53|-3.32||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-3.32|-9.53|=0.004
71835074|NCT05687903|143174786|SUPERIORITY||Estimate of LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-14.44|-8.16||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-8.16|-14.44|<0.001
71835075|NCT05687903|143174786|SUPERIORITY||Estimate of LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-13.35|-7.27||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-7.27|-13.35|<0.001
71835076|NCT05687903|143174786|SUPERIORITY||Estimate of LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-11.84|-5.75||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||-5.75|-11.84|<0.001
71835077|NCT05687903|143174787|SUPERIORITY||IRR|0.48|||=|0.25|TWO_SIDED|95.0|0.25|0.93||GEE model featuring a negative binomial distribution was used for analysis where incidence rate was exponentiated LS mean \& incidence rate ratio (IRR) was exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.93|0.25|=0.250
71891367|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.266|-0.259|0.9801
71835078|NCT05687903|143174787|SUPERIORITY||IRR|0.36|||=|0.034|TWO_SIDED|95.0|0.16|0.79||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.79|0.16|=0.034
71835079|NCT05687903|143174787|SUPERIORITY||IRR|0.28|||=|0.003|TWO_SIDED|95.0|0.13|0.6||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||0.60|0.13|=0.003
71747665|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|1.52|||<|0.001|TWO_SIDED|95.0|0.86|2.18|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||2.18|0.86|<0.001
71666555|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.08||||0.5281|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||0.11|-0.28|0.5281
71891368|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.557|0.030|0.0289
71891369|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.330|-0.202|0.6382
71891370|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.391|-0.140|0.3525
71891371|NCT01431287|143304551|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.203|-0.327|0.6457
71891372|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0095|TWO_SIDED|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.008|0.0095
71891373|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
71891374|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.013||0.0112|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0112
71666556|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.09||||0.5747|TWO_SIDED|90.0|-0.28|0.11||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.11|-0.28|0.5747
71747666|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.002|TWO_SIDED|95.0|0.41|1.75|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.75|0.41|0.002
71891375|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.068|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.068|<0.0001
71891376|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
71891377|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9514|TWO_SIDED|95.0|-0.024|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.024|0.9514
71780054|NCT01681472|143059676|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0313
71666557|NCT04856917|142847591|SUPERIORITY||Risk Difference (RD)|-0.05||||0.5081|TWO_SIDED|90.0|-0.24|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.14|-0.24|0.5081
71747667|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.271|TWO_SIDED|95.0|-0.29|1.03|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.03|-0.29|0.271
71747668|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.235|TWO_SIDED|95.0|-0.26|1.06|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.06|-0.26|0.235
71747669|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.007|TWO_SIDED|95.0|0.25|1.56|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.56|0.25|0.007
71747670|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.923|TWO_SIDED|95.0|-0.63|0.69|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.69|-0.63|0.923
71747671|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.108|TWO_SIDED|95.0|-0.12|1.19|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.19|-0.12|0.108
71666558|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|0.01||||0.8338|TWO_SIDED|90.0|-0.19|0.2||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 2||0.20|-0.19|0.8338
71666559|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.12||||0.1142|TWO_SIDED|90.0|-0.31|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.09|-0.31|0.1142
71666560|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.2||||0.3433|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 4||0.00|-0.38|0.3433
71666561|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.17||||0.1129|TWO_SIDED|90.0|-0.37|0.04||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 2||0.04|-0.37|0.1129
71747672|NCT03084796|143003811|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.134|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||"Week 6~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.16|-0.16|0.134
71747673|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|7.88||||0.022|TWO_SIDED|95.0|1.13|14.63|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||14.63|1.13|0.022
71780055|NCT01681472|143059676|SUPERIORITY|||||||0.4777|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4777
71780056|NCT01681472|143059677|SUPERIORITY|||||||0.2716|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2716
71666562|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.2||||0.2842|TWO_SIDED|90.0|-0.38|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 8||0.00|-0.38|0.2842
71747674|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|6.78||||0.048|TWO_SIDED|95.0|0.07|13.48|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.48|0.07|0.048
71666563|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.34||||0.0212|TWO_SIDED|90.0|-0.52|-0.13||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 8||-0.13|-0.52|0.0212
71747675|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|6.65||||0.053|TWO_SIDED|95.0|-0.09|13.4|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.40|-0.09|0.053
71780057|NCT01681472|143059677|SUPERIORITY|||||||0.0124|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0124
71780058|NCT01681472|143059677|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
71891378|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.069|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.119|0.069|<0.0001
71747676|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|9.29||||0.007|TWO_SIDED|95.0|2.55|16.04|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.04|2.55|0.007
71747677|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|4.61||||0.191|TWO_SIDED|95.0|-2.31|11.53|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.53|-2.31|0.191
71780059|NCT01681472|143059677|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
71780060|NCT01681472|143059677|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0039
71891379|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0131|TWO_SIDED|95.0|-0.057|-0.007||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.007|-0.057|0.0131
71891380|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.086|-0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.036|-0.086|<0.0001
71891381|NCT01431287|143304552|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.0243|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0243
71891382|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.145|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.119|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.170|0.119|<0.0001
71666564|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.07||||0.7665|TWO_SIDED|90.0|-0.28|0.14||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 12||0.14|-0.28|0.7665
71747678|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.747|TWO_SIDED|95.0|-7.8|5.6|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.60|-7.80|0.747
71780061|NCT01681472|143059677|SUPERIORITY|||||||0.0454|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0454
71747679|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.72|TWO_SIDED|95.0|-7.96|5.5|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.50|-7.96|0.720
71747680|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|1.41||||0.68|TWO_SIDED|95.0|-5.31|8.14|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.14|-5.31|0.680
71747681|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.971|TWO_SIDED|95.0|-6.82|6.57|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.57|-6.82|0.971
71747682|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|2.52||||0.46|TWO_SIDED|95.0|-4.17|9.21|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.21|-4.17|0.460
71780062|NCT01681472|143059678|SUPERIORITY|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0092
71780063|NCT01681472|143059678|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.8303
71780064|NCT01681472|143059678|SUPERIORITY|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1182
71780065|NCT01681472|143059678|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
71780066|NCT01681472|143059678|SUPERIORITY|||||||0.3184|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3184
71780067|NCT01681472|143059678|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
71780068|NCT01681472|143059679|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
71780069|NCT01681472|143059679|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
71780070|NCT01681472|143059679|SUPERIORITY|||||||0.0428|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0428
71780071|NCT01681472|143059679|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0003
71780072|NCT01681472|143059679|SUPERIORITY|||||||0.4309|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4309
71780073|NCT01681472|143059679|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
71780074|NCT01681472|143059680|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
71780075|NCT01681472|143059680|SUPERIORITY|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0034
71780076|NCT01681472|143059680|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780077|NCT01681472|143059680|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71747683|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.441|TWO_SIDED|95.0|-4.09|9.37|||Mixed Models Analysis|||"Inter-Visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.37|-4.09|0.441
71747684|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.07|TWO_SIDED|95.0|-0.55|14.08|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.08|-0.55|0.070
71747685|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|8.44||||0.023|TWO_SIDED|95.0|1.16|15.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||15.72|1.16|0.023
71747686|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|6.96||||0.064|TWO_SIDED|95.0|-0.4|14.31|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.31|-0.40|0.064
71747687|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|11.08||||0.003|TWO_SIDED|95.0|3.79|18.38|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||18.38|3.79|0.003
71747688|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.274|TWO_SIDED|95.0|-3.32|11.72|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.72|-3.32|0.274
71747689|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.649|TWO_SIDED|95.0|-5.57|8.93|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||8.93|-5.57|0.649
71747690|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.958|TWO_SIDED|95.0|-7.12|7.51|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||7.51|-7.12|0.958
71747691|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|4.32||||0.242|TWO_SIDED|95.0|-2.93|11.58|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.58|-2.93|0.242
71747692|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.69|TWO_SIDED|95.0|-8.77|5.81|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.81|-8.77|0.690
71747693|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|2.64||||0.473|TWO_SIDED|95.0|-4.58|9.87|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.87|-4.58|0.473
71747694|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|4.13||||0.267|TWO_SIDED|95.0|-3.17|11.43|||Mixed Models Analysis|||"Inter-Visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.43|-3.17|0.267
71835080|NCT05687903|143174787|SUPERIORITY||IRR|0.67|||=|0.25|TWO_SIDED|95.0|0.35|1.29||The GEE model featuring a negative binomial distribution was used for analysis where the incidence rate was the exponentiated LS mean and the IRR was the exponentiated LS mean difference from placebo. Reported p-value is adjusted for multiplicity.|GEE|||The GEE model was used for analysis with fixed effects for visit, treatment, treatment-by-visit interaction, Baseline WCR, age, and prior use of narcolepsy medications.||1.29|0.35|=0.250
71891383|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.085|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.136|0.085|<0.0001
71891384|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.094|<0.0001
71747695|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|7.32||||0.032|TWO_SIDED|95.0|0.65|13.99|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.99|0.65|0.032
71747696|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|7.61||||0.025|TWO_SIDED|95.0|0.97|14.24|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||14.24|0.97|0.025
71666565|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.22||||0.1777|TWO_SIDED|90.0|-0.42|0.0||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 12||-0.00|-0.42|0.1777
71747697|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.046|TWO_SIDED|95.0|0.12|13.49|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||13.49|0.12|0.046
71666566|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.12||||0.3741|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 400/200 mg vs Placebo: Week 20||0.09|-0.33|0.3741
71666567|NCT04856917|142847592|SUPERIORITY||Risk Difference (RD)|-0.13||||0.3321|TWO_SIDED|90.0|-0.33|0.09||Adjusted P-value obtained from Cochran-Mantel-Haenszel test (ANOVA for row means), adjusting for facial IGA at baseline.|Cochran-Mantel-Haenszel||Somers'D statistic and tanh\^(-1) transformed 90% CI.|Imsidolimab 200/100 mg vs Placebo: Week 20||0.09|-0.33|0.3321
71666568|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.7932|TWO_SIDED|90.0|-1.56|2.14||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.14|-1.56|0.7932
71666569|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.12||0.4365|TWO_SIDED|90.0|-0.99|2.73||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||2.73|-0.99|0.4365
71747698|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|10.19||||0.003|TWO_SIDED|95.0|3.52|16.85|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||16.85|3.52|0.003
71747699|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.207|TWO_SIDED|95.0|-2.45|11.25|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||11.25|-2.45|0.207
71747700|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.932|TWO_SIDED|95.0|-6.33|6.91|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.91|-6.33|0.932
71666570|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8543|TWO_SIDED|90.0|-1.92|1.54||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||1.54|-1.92|0.8543
71747701|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.879|TWO_SIDED|95.0|-7.17|6.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||6.14|-7.17|0.879
71747702|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.396|TWO_SIDED|95.0|-3.77|9.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.50|-3.77|0.396
71747703|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.812|TWO_SIDED|95.0|-7.44|5.83|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||5.83|-7.44|0.812
71747704|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.444|TWO_SIDED|95.0|-4.03|9.19|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||9.19|-4.03|0.444
71747705|NCT03084796|143003812|SUPERIORITY||Mean Difference (Final Values)|3.38||||0.319|TWO_SIDED|95.0|-3.27|10.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||10.04|-3.27|0.319
71780078|NCT01681472|143059680|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
71666571|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.8726|TWO_SIDED|90.0|-1.91|1.58||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||1.58|-1.91|0.8726
71666572|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07||0.5983|TWO_SIDED|90.0|-1.22|2.35||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.35|-1.22|0.5983
71666573|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.09||0.3396|TWO_SIDED|90.0|-0.77|2.86||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||2.86|-0.77|0.3396
71666574|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.97||0.5305|TWO_SIDED|90.0|-2.23|1.01||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||1.01|-2.23|0.5305
71666575|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0819|TWO_SIDED|90.0|0.09|3.29||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||3.29|0.09|0.0819
71891385|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.081|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.132|0.081|<0.0001
71747706|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.001|TWO_SIDED|95.0|-0.67|-0.18|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed, using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.18|-0.67|<0.001
71747707|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.023|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.53|0.023
71747708|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.067|TWO_SIDED|95.0|-0.47|0.02|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.02|-0.47|0.067
71747709|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.66|-0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.66|<0.001
71747710|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.084|TWO_SIDED|95.0|-0.47|0.03|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.47|0.084
71747711|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.243|TWO_SIDED|95.0|-0.1|0.39|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.39|-0.10|0.243
71747712|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.112|TWO_SIDED|95.0|-0.05|0.44|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.44|-0.05|0.112
71747713|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.929|TWO_SIDED|95.0|-0.23|0.26|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.23|0.929
71666576|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.09||0.0243|TWO_SIDED|90.0|0.69|4.31||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||4.31|0.69|0.0243
71666577|NCT04856917|142847593|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.05||0.1061|TWO_SIDED|90.0|-0.03|3.46||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline DLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||3.46|-0.03|0.1061
71747714|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.30|-0.19|0.668
71747715|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.281|TWO_SIDED|95.0|-0.38|0.11|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.11|-0.38|0.281
71780079|NCT01681472|143059680|SUPERIORITY|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0055
71747716|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.134|TWO_SIDED|95.0|-0.43|0.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.43|0.134
71747717|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.003|TWO_SIDED|95.0|-0.7|-0.14|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.14|-0.70|0.003
71747718|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.02|TWO_SIDED|95.0|-0.61|-0.05|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.05|-0.61|0.020
71747719|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.017|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.62|0.017
71747720|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.24|-0.80|<0.001
71747721|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.115|TWO_SIDED|95.0|-0.52|0.06|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.06|-0.52|0.115
71747722|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.532|TWO_SIDED|95.0|-0.19|0.36|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.19|0.532
71747723|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.603|TWO_SIDED|95.0|-0.21|0.35|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.35|-0.21|0.603
71747724|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.46|TWO_SIDED|95.0|-0.38|0.17|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.17|-0.38|0.460
71780080|NCT01681472|143059681|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
71780081|NCT01681472|143059681|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
71780082|NCT01681472|143059681|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71835081|NCT01631214|143174810|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|0.36|0.64|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.36|<0.001
71747725|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.921|TWO_SIDED|95.0|-0.29|0.26|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD.~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.26|-0.29|0.921
71747726|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.172|TWO_SIDED|95.0|-0.47|0.08|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.47|0.172
71747727|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.21|TWO_SIDED|95.0|-0.46|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.10|-0.46|0.210
71780083|NCT01681472|143059681|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||<0.0001
71666578|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.67||0.9333|TWO_SIDED|90.0|-2.69|2.97||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 2||2.97|-2.69|0.9333
71780084|NCT01681472|143059681|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
71780085|NCT01681472|143059681|SUPERIORITY|||||||0.0338|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of \[6S\]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0338
71780086|NCT01681472|143059682|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780087|NCT01681472|143059682|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780088|NCT01681472|143059682|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780089|NCT01681472|143059682|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780090|NCT01681472|143059682|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780091|NCT01681472|143059682|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780092|NCT01681472|143059683|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780093|NCT01681472|143059683|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780094|NCT01681472|143059683|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71891386|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.110|0.059|<0.0001
71780095|NCT01681472|143059683|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780096|NCT01681472|143059683|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
71780097|NCT01681472|143059683|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780098|NCT01681472|143059684|SUPERIORITY|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0728
71780099|NCT01681472|143059684|SUPERIORITY|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2246
71780100|NCT01681472|143059684|SUPERIORITY|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0166
71780101|NCT01681472|143059684|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1752
71780102|NCT01681472|143059684|SUPERIORITY|||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.9581
71780103|NCT01681472|143059684|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0118
71747728|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.67|-0.17|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.17|-0.67|<0.001
71747729|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.016|TWO_SIDED|95.0|-0.55|-0.06|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.06|-0.55|0.016
71835082|NCT01631214|143174810|SUPERIORITY||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.38|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.38|
71747730|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.025|TWO_SIDED|95.0|-0.54|-0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.04|-0.54|0.025
71747731|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.22|-0.72|<0.001
71747732|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.083|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.03|-0.48|0.083
71747733|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.355|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.36|-0.13|0.355
71747734|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.283|TWO_SIDED|95.0|-0.11|0.38|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.38|-0.11|0.283
71747735|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.712|TWO_SIDED|95.0|-0.29|0.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.20|-0.29|0.712
71747736|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.877|TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.27|-0.23|0.877
71747737|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.195|TWO_SIDED|95.0|-0.41|0.08|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.08|-0.41|0.195
71747738|NCT03084796|143003813|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.15|TWO_SIDED|95.0|-0.43|0.07|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.07|-0.43|0.150
71747739|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.967||||0.016|TWO_SIDED|95.0|-1.753|-0.181|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Analyzed using linear mixed model repeated for measurements (MMRM), including treatment, inter-visit period, treatment by inter-visit period interaction, US regions (Midwest, Northeast, South and West), and smoking status at screening as fixed effects, and the baseline value, and baseline by inter-visit period interaction as covariates."||-0.181|-1.753|0.016
71747740|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.039|TWO_SIDED|95.0|-1.606|-0.043|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.043|-1.606|0.039
71747741|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.227||||0.002|TWO_SIDED|95.0|-2.012|-0.441|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.441|-2.012|0.002
71747742|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.949||||0.018|TWO_SIDED|95.0|-1.733|-0.164|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.164|-1.733|0.018
71835083|NCT01631214|143174810|SUPERIORITY||Absolute risk reduction|4.03|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|2.5|5.57||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||5.57|2.50|
71747743|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.566||||0.169|TWO_SIDED|95.0|-1.374|0.242|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.242|-1.374|0.169
71747744|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.72|TWO_SIDED|95.0|-0.638|0.923|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.923|-0.638|0.720
71747745|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.515|TWO_SIDED|95.0|-1.043|0.523|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.523|-1.043|0.515
71747746|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.963|TWO_SIDED|95.0|-0.764|0.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.800|-0.764|0.963
71747747|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.402||||0.311|TWO_SIDED|95.0|-1.182|0.377|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.377|-1.182|0.311
71747748|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.754|TWO_SIDED|95.0|-0.903|0.654|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.654|-0.903|0.754
71747749|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.278||||0.485|TWO_SIDED|95.0|-0.503|1.06|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.060|-0.503|0.485
71747750|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.349||||0.005|TWO_SIDED|95.0|-2.294|-0.403|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.403|-2.294|0.005
71747751|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.159||||0.016|TWO_SIDED|95.0|-2.1|-0.218|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.218|-2.100|0.016
71747752|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.466||||0.003|TWO_SIDED|95.0|-2.416|-0.516|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.516|-2.416|0.003
71747753|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.004|TWO_SIDED|95.0|-2.337|-0.454|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.454|-2.337|0.004
71747754|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.824||||0.097|TWO_SIDED|95.0|-1.797|0.15|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.150|-1.797|0.097
71747755|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.69|TWO_SIDED|95.0|-0.746|1.126|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.126|-0.746|0.690
71891387|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.013||0.047|TWO_SIDED|95.0|0.0|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.051|0.000|0.0470
71747756|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.117||||0.808|TWO_SIDED|95.0|-1.061|0.827|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.827|-1.061|0.808
71747757|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.922|TWO_SIDED|95.0|-0.983|0.889|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.889|-0.983|0.922
71891388|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.107|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.107|<0.0001
71666579|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.67||0.3972|TWO_SIDED|90.0|-1.4|4.27||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 2||4.27|-1.40|0.3972
71747758|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.307||||0.522|TWO_SIDED|95.0|-1.248|0.634|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.634|-1.248|0.522
71747759|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.237||||0.618|TWO_SIDED|95.0|-1.17|0.696|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.696|-1.170|0.618
71747760|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.884|TWO_SIDED|95.0|-0.871|1.012|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||1.012|-0.871|0.884
71747761|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.158||||0.006|TWO_SIDED|95.0|-1.978|-0.337|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment A (CHF 5259 pMDI 12.5 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.337|-1.978|0.006
71747762|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.992||||0.017|TWO_SIDED|95.0|-1.808|-0.175|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.175|-1.808|0.017
71747763|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.346||||0.001|TWO_SIDED|95.0|-2.168|-0.524|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.524|-2.168|0.001
71747764|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-1.172||||0.005|TWO_SIDED|95.0|-1.991|-0.353|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||-0.353|-1.991|0.005
71747765|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.695||||0.107|TWO_SIDED|95.0|-1.539|0.149|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment F (Tiotropium 18 μg TDD) versus Treatment E (Placebo).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.149|-1.539|0.107
71747766|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.166||||0.689|TWO_SIDED|95.0|-0.648|0.98|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment B (CHF 5259 pMDI 25 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.980|-0.648|0.689
71747767|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.188||||0.651|TWO_SIDED|95.0|-1.007|0.63|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.630|-1.007|0.651
71747768|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.973|TWO_SIDED|95.0|-0.83|0.801|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment A (CHF 5259 pMDI 12.5 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.801|-0.830|0.973
71747769|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.355||||0.393|TWO_SIDED|95.0|-1.17|0.461|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment C (CHF 5259 pMDI 50 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.461|-1.170|0.393
71835084|NCT01631214|143174811|SUPERIORITY|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.61|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)|||0.88|0.61|<0.001
71845286|NCT05886777|143204399|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.43|||||TWO_SIDED|97.5|1.131|1.808|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.808|1.131|
71891389|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.060|0.009|0.0083
71666580|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.11||0.0662|TWO_SIDED|90.0|0.23|3.99||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 4||3.99|0.23|0.0662
71780104|NCT01681472|143059685|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666581|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.8898|TWO_SIDED|90.0|-1.73|2.04||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 4||2.04|-1.73|0.8898
71780105|NCT01681472|143059685|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780106|NCT01681472|143059685|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780107|NCT01681472|143059685|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780108|NCT01681472|143059685|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780109|NCT01681472|143059685|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71780110|NCT01681472|143059686|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780111|NCT01681472|143059686|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780112|NCT01681472|143059686|SUPERIORITY|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0022
71780113|NCT01681472|143059686|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780114|NCT01681472|143059686|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780115|NCT01681472|143059686|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780116|NCT01681472|143059687|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71845287|NCT05886777|143204400|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 6, 4, respectively.|Geometric mean ratio|1.37|||||TWO_SIDED|97.5|1.06|1.773|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).|||1.773|1.060|
71780117|NCT01681472|143059687|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780118|NCT01681472|143059687|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780119|NCT01681472|143059687|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780120|NCT01681472|143059687|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
71780121|NCT01681472|143059687|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780122|NCT01681472|143059688|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
71666582|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.06||0.3664|TWO_SIDED|90.0|-0.85|2.82||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 8||2.82|-0.85|0.3664
71747770|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|-0.181||||0.663|TWO_SIDED|95.0|-0.993|0.632|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment B (CHF 5259 pMDI 25 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.632|-0.993|0.663
71747771|NCT03084796|143003814|SUPERIORITY||Mean Difference (Final Values)|0.174||||0.676|TWO_SIDED|95.0|-0.643|0.991|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups for this analysis were:~Treatment D (CHF 5259 pMDI 100 μg TDD) versus Treatment C (CHF 5259 pMDI 50 μg TDD).~Statistical analysis was performed as described for the statistical analysis 1 of this outcome measure."||0.991|-0.643|0.676
71747772|NCT02741245|143003850|OTHER||Difference in M-estimates|-35.9|||<|0.001|TWO_SIDED|95.0|-39.9|-32.0|||Shapiro-Wilk test|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach||||-32.0|-39.9|<0.001
71747773|NCT02741245|143003850|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-14.8|||<|0.001|TWO_SIDED|95.0|-18.0|-11.6|||Shapiro-Wilk test|||||-11.6|-18.0|<0.001
71747774|NCT02741245|143003850|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-41.8|||<|0.001|TWO_SIDED|95.0|-45.8|-37.9|||Shapiro-Wilk test|||||-37.9|-45.8|<0.001
71747775|NCT02741245|143003850|OTHER|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Differecne in M-estimates|-13.3|||<|0.001|TWO_SIDED|95.0|-16.6|-10.1|||Shapiro-Wilk test|||||-10.1|-16.6|<0.001
71747776|NCT01300234|143003889|SUPERIORITY_OR_OTHER||percentage of participants|58.5|||<|0.0001|TWO_SIDED|97.5|45.8|71.3||HBeAg-positive participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach is used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||71.3|45.8|<0.0001
71747777|NCT01300234|143003889|SUPERIORITY_OR_OTHER||percentage of participants|25.6|||<|0.0001|TWO_SIDED|97.5|16.7|34.3||HBeAg-negative participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach was used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA \<400 copies/mL at Week 48 in the TDF group and the ADV group."|||34.3|16.7|<0.0001
71747778|NCT01928927|143003946|SUPERIORITY||Theta statistic|0.5||||0.97|TWO_SIDED|95.0|0.26|0.73||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.73|0.26|0.97
71747779|NCT01928927|143003947|SUPERIORITY||Theta statistic|0.57||||0.61|TWO_SIDED|95.0|0.31|0.83||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is \<= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50||0.83|0.31|0.61
71780123|NCT01681472|143059688|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
71780124|NCT01681472|143059688|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780125|NCT01681472|143059688|SUPERIORITY|||||||0.2725|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2725
71780126|NCT01681472|143059688|SUPERIORITY|||||||0.1893|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1893
71780127|NCT01681472|143059688|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71780128|NCT01681472|143059689|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780129|NCT01681472|143059689|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780130|NCT01681472|143059689|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780131|NCT01681472|143059689|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
71780132|NCT01681472|143059689|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
71780133|NCT01681472|143059689|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71666583|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0655|TWO_SIDED|90.0|0.25|4.05||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 8||4.05|0.25|0.0655
71780134|NCT01681472|143059690|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
71780135|NCT01681472|143059690|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666584|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.6921|TWO_SIDED|90.0|-1.61|2.57||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 12||2.57|-1.61|0.6921
71666585|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0406|TWO_SIDED|90.0|0.59|4.88||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 12||4.88|0.59|0.0406
71666586|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04||0.6872|TWO_SIDED|90.0|-2.24|1.38||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 400/200 mg vs Placebo: Week 20||1.38|-2.24|0.6872
71666587|NCT04856917|142847594|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.08||0.3392|TWO_SIDED|90.0|-0.81|2.92||LS Mean, SE, 90% CI, \& p-value was based on a LRMM which included treatment, visit, treatment by visit interaction \& facial IGA at baseline (Grade 3 vs. 4) as categorical covariates \& baseline CDLQI as continuous covariate.|LRMM|||Imsidolimab 200/100 mg vs Placebo: Week 20||2.92|-0.81|0.3392
71666588|NCT01169337|142847597|SUPERIORITY|||||||0.0005|||||||Log Rank|stratified 1-sided log-rank test||||||0.0005
71666589|NCT00588770|142847614|SUPERIORITY|||||||0.22||||||The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.|Log Rank|||The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.||||0.22
71666590|NCT03698019|142847619|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.004|TWO_SIDED||||||Log Rank|||||||0.004
71666591|NCT01856192|142847624|SUPERIORITY|||||||0.03|||||||Log Rank|Stratified log rank test||||||0.03
71666592|NCT04976621|142847642|OTHER|Because this was a feasibility study, we did not compute inferential statistics and did not include a power calculation.||||||||||||Because this was a feasibility study, inferential statistics were not computed.||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
71666593|NCT04976621|142847643|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
71666594|NCT04976621|142847644|OTHER|||||||||||||||||This feasibility study assessed preliminary evidence of treatment response. We have reported only descriptive statistics for quantitative findings. We have not reported inferential statistics, in keeping with the purpose of the VA SPiRE grant mechanism through which the study was funded. We assessed change in participant response by comparing the mean change in the outcome from baseline to follow-up in Group 1 (BA) and Group 2 (TAU). We inspected trends and directions of change in both groups.|Because this is a feasibility study, inferential statistics were not computed. We examined the trends and direction of change in the baseline mean score and follow-up mean score between the two groups.|||
71666595|NCT04976621|142847645|OTHER||||||||||||||||||This analysis involved examination of the percentage that scored above a mean of 3.0 (our criteria for acceptability in this feasibility study).|||
71666596|NCT04976621|142847646|OTHER|||||||||||||||||Descriptive statistics are used to describe acceptability/satisfaction for those who received the BA intervention. This tool is completed after the last intervention session when the qualitative interview is also conducted.|Descriptive statistics are used in this feasibility study. We are not using inferential statistics to test for statistical significance.|||
71666597|NCT04976621|142847647|OTHER||||||||||||||||||Descriptive statistics are used to describe recruitment.|||
71666598|NCT04976621|142847648|OTHER||||||||||||||||||One measure of retention was the percent in each group who completed the study, meaning completed the Time 2 follow-up interview (that occurred 3-4 months after the baseline interview). Another measure of retention was the percent in the treatment group that completed four or more treatment sessions.|||
71780136|NCT01681472|143059690|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0021
71780137|NCT01681472|143059690|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71835085|NCT01631214|143174812|SUPERIORITY|If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.1||0.04|TWO_SIDED|95.0|0.66|0.99||The adjusted 2-sided p-value is reported.|Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.99|0.66|0.040
71835086|NCT01631214|143174813|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.65|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.56|0.76|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.76|0.56|<0.001
71835087|NCT01631214|143174814|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.49|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.37|0.64|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.64|0.37|<0.001
71835088|NCT01631214|143174814|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.4|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.66|0.40|
71835089|NCT01631214|143174814|SUPERIORITY||Absolute risk reduction|4.44|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|2.8|6.08||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||6.08|2.80|
71835090|NCT01631214|143174815|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.73|STANDARD_ERROR_OF_MEAN|0.11||0.004|TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.90|0.59|0.004
71835091|NCT01631214|143174816|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.2||0.015|TWO_SIDED|95.0|0.42|0.92|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.92|0.42|0.015
71835092|NCT01631214|143174817|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.25||0.008|TWO_SIDED|95.0|0.31|0.85|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.85|0.31|0.008
71747815|NCT00861705|143004245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0018
71747816|NCT00861705|143004246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0089|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in \> 95% power.||||0.0089
71747817|NCT00861705|143004247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.0029
71780138|NCT01681472|143059690|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
71780139|NCT01681472|143059690|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780140|NCT01681472|143059691|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71747818|NCT00861705|143004248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||||||0.057
71780141|NCT01681472|143059691|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780142|NCT01681472|143059691|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780143|NCT01681472|143059691|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780144|NCT01681472|143059691|SUPERIORITY|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0009
71835093|NCT01631214|143174817|SUPERIORITY||Risk Ratio (RR)|0.52|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|0.32|0.85|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.85|0.32|
71780145|NCT01681472|143059691|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71747819|NCT00861705|143004252|SUPERIORITY||Cox Proportional Hazard|1.19|||||TWO_SIDED|95.0|0.67|2.1||||||||2.10|0.67|
71747820|NCT00861705|143004252|SUPERIORITY||Cox Proportional Hazard|1.43|||||TWO_SIDED|95.0|0.82|2.47||||||||2.47|0.82|
71747821|NCT00861705|143004252|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
71780146|NCT01681472|143059692|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0240
71780147|NCT01681472|143059692|SUPERIORITY|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1336
71780148|NCT01681472|143059692|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780149|NCT01681472|143059692|SUPERIORITY|||||||0.1551|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1551
71780150|NCT01681472|143059692|SUPERIORITY|||||||0.1563|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1563
71780151|NCT01681472|143059692|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71747822|NCT00861705|143004253|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.66|1.75||||||||1.75|0.66|
71747823|NCT00861705|143004253|SUPERIORITY||Cox Proportional Hazard|1.2|||||TWO_SIDED|95.0|0.74|1.92||||||||1.92|0.74|
71747824|NCT00861705|143004253|SUPERIORITY||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.49|1.37||||||||1.37|0.49|
71747825|NCT00861705|143004254|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.66|2.03||||||||2.03|0.66|
71747826|NCT00861705|143004254|SUPERIORITY||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.72|2.16||||||||2.16|0.72|
71747827|NCT00861705|143004254|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.53|1.7||||||||1.70|0.53|
71780152|NCT01681472|143059693|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71835094|NCT01631214|143174817|SUPERIORITY||Absolute risk reduction|1.21|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|0.33|2.1||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||2.10|0.33|
71891390|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.013||0.3329|TWO_SIDED|95.0|-0.013|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.038|-0.013|0.3329
71666599|NCT04976621|142847649|OTHER||||||||||||||||||For each of five participants who received the intervention, we reviewed a transcript of 1 intervention session for treatment fidelity. The criterion is that no more than 15% of sessions observed or audiotaped will have a mean less than 2.0.|||
71780153|NCT01681472|143059693|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780154|NCT01681472|143059693|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780155|NCT01681472|143059693|SUPERIORITY|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0142
71666600|NCT05992623|142847650|SUPERIORITY|||||||0.565|||||||Chi-squared|||||||0.565
71666601|NCT05992623|142847651|SUPERIORITY|||||||0.617|||||||Chi-squared|||||||0.617
71666602|NCT05992623|142847652|SUPERIORITY||Mean Difference (Final Values)|0.04|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71780156|NCT01681472|143059693|SUPERIORITY|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0085
71780157|NCT01681472|143059693|SUPERIORITY|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0024
71780158|NCT01681472|143059694|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||1.0000
71780159|NCT01681472|143059694|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666603|NCT05219448|142847689|SUPERIORITY||Mean Difference (Final Values)|7.4||||0.17|TWO_SIDED|95.0|-3.2|18.0||Unadjusted p value presented. The a priori threshold for statistical significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same when compared to children in the no-treatment control arm (measured through hair biomarker).||18.0|-3.2|0.17
71780160|NCT01681472|143059694|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
71780161|NCT01681472|143059694|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780162|NCT01681472|143059694|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0005
71780163|NCT01681472|143059694|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780164|NCT01681472|143059695|SUPERIORITY|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0056
71780165|NCT01681472|143059695|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780166|NCT01681472|143059695|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0010
71780167|NCT01681472|143059695|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780168|NCT01681472|143059695|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
71780169|NCT01681472|143059695|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780170|NCT01681472|143059696|SUPERIORITY|||||||0.1796|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1796
71780171|NCT01681472|143059696|SUPERIORITY|||||||0.3243|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.3243
71780172|NCT01681472|143059696|SUPERIORITY|||||||0.0263|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0263
71891391|NCT01431287|143304553|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.013||0.0958|TWO_SIDED|95.0|-0.004|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.047|-0.004|0.0958
71780173|NCT01681472|143059696|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
71780174|NCT01681472|143059696|SUPERIORITY|||||||0.2041|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.2041
71780175|NCT01681472|143059696|SUPERIORITY|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||||||0.0061
71780176|NCT01681472|143059697|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780177|NCT01681472|143059697|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71891392|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
71891393|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.086|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.139|0.086|<0.0001
71666604|NCT05219448|142847690|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.6|TWO_SIDED|95.0|-24.3|14.0||Unadjusted P-value. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community A arm when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||14.0|-24.3|0.60
71780178|NCT01681472|143059697|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71891394|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
71891395|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.144|0.092|<0.0001
71891396|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.072|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.125|0.072|<0.0001
71891397|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.3008|TWO_SIDED|95.0|-0.012|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.012|0.3008
71891398|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.158|0.105|<0.0001
71891399|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.014||0.1484|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1484
71780179|NCT01681472|143059697|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780180|NCT01681472|143059697|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780181|NCT01681472|143059697|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780182|NCT01681472|143059698|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0268
71666605|NCT05219448|142847690|SUPERIORITY||Mean Difference (Final Values)|-24.7||||0.013|TWO_SIDED|95.0|-44.1|-5.4||The P-value is unadjusted. The threshold for significance is 0.05.|Regression, Linear|||Null hypothesis: The change in added sugar intake from baseline to 6-months will be the same for caregivers in community B when compared to caregivers in the no-treatment control arm (measured through hair biomarker).||-5.4|-44.1|0.013
71780183|NCT01681472|143059698|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666606|NCT01565356|142847714|SUPERIORITY_OR_OTHER||Kappa statistic|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||Cohen's (simple) kappa statistic||1.00|1.00|
71780184|NCT01681472|143059698|SUPERIORITY|||||||0.0227|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0227
71780185|NCT01681472|143059698|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666607|NCT01894087|142847716|SUPERIORITY||Incidence Rate Ratio|0.72|||||TWO_SIDED|95.0|0.59|0.87|||||Numerator is Therapist-led Brief Intervention, Denominator is Enhanced Usual Care only.|Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome||0.87|0.59|
71780186|NCT01681472|143059698|SUPERIORITY|||||||0.0933|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0933
71780187|NCT01681472|143059698|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780188|NCT01681472|143059699|SUPERIORITY|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0177
71780189|NCT01681472|143059699|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780190|NCT01681472|143059699|SUPERIORITY|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0058
71780191|NCT01681472|143059699|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780192|NCT01681472|143059699|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0043
71780193|NCT01681472|143059699|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666608|NCT01894087|142847717|SUPERIORITY||Slope|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Numerator is the Therapist-Led Brief Intervention and Denominator is Enhanced Usual Care only|Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.||0.40|-0.20|
71780194|NCT01681472|143059700|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780195|NCT01681472|143059700|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780196|NCT01681472|143059700|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780197|NCT01681472|143059700|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666609|NCT01894087|142847718|SUPERIORITY||Incidence Rate Ratio|1.11|||||TWO_SIDED|95.0|0.93|1.33|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of using opioids as prescribed). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.||1.33|0.93|
71780198|NCT01681472|143059700|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780199|NCT01681472|143059700|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666610|NCT01894087|142847718|SUPERIORITY||Incidence Rate Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.||0.90|0.65|
71780200|NCT01681472|143059701|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71891400|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9981|TWO_SIDED|95.0|-0.026|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.026|0.9981
71780201|NCT01681472|143059701|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71666611|NCT01894087|142847718|SUPERIORITY||Incidence Rate Ratio|0.97|||||TWO_SIDED|95.0|0.8|1.19|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.||1.19|0.80|
71780202|NCT01681472|143059701|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780203|NCT01681472|143059701|SUPERIORITY|||||||0.0668|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0668
71780204|NCT01681472|143059701|SUPERIORITY|||||||0.0502|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0502
71780205|NCT01681472|143059701|SUPERIORITY|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0081
71780206|NCT01681472|143059702|SUPERIORITY|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0011
71780207|NCT01681472|143059702|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780208|NCT01681472|143059702|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780209|NCT01681472|143059702|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780210|NCT01681472|143059702|SUPERIORITY|||||||0.6691|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.6691
71666612|NCT01894087|142847719|SUPERIORITY||Incidence Rate Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.92|||||Numerator is Therapist-Led Brief Intervention, Denominator is Enhanced Usual Care only|Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome||0.92|0.70|
71666613|NCT05534061|142847720|SUPERIORITY||Odds Ratio (OR)|0.98||||0.944|TWO_SIDED|95.0|0.62|1.56||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.56|0.62|.944
71780211|NCT01681472|143059702|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780212|NCT01681472|143059703|SUPERIORITY|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0015
71780213|NCT01681472|143059703|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780214|NCT01681472|143059703|SUPERIORITY|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0640
71666614|NCT05534061|142847721|SUPERIORITY||Odds Ratio (OR)|1.01||||0.952|TWO_SIDED|95.0|0.62|1.65||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||1.65|0.62|.952
71666615|NCT05534061|142847722|SUPERIORITY||Odds Ratio (OR)|1.16||||0.768|TWO_SIDED|95.0|0.43|3.11||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||3.11|0.43|.768
71780215|NCT01681472|143059703|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780216|NCT01681472|143059703|SUPERIORITY|||||||0.1213|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1213
71780217|NCT01681472|143059703|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780218|NCT01681472|143059704|SUPERIORITY|||||||0.1791|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.1791
71780219|NCT01681472|143059704|SUPERIORITY|||||||0.4945|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.4945
71780220|NCT01681472|143059704|SUPERIORITY|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0014
71780221|NCT01681472|143059704|SUPERIORITY|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5990
71780222|NCT01681472|143059704|SUPERIORITY|||||||0.0303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0303
71780223|NCT01681472|143059704|SUPERIORITY|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0107
71780224|NCT01681472|143059705|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780225|NCT01681472|143059705|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780226|NCT01681472|143059705|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0
71780227|NCT01681472|143059705|SUPERIORITY|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0125
71780228|NCT01681472|143059705|SUPERIORITY|||||||0.0017|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.0017
71780229|NCT01681472|143059705|SUPERIORITY|||||||0.5286|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene's test.||||0.5286
71780230|NCT01681472|143059706|OTHER||Correlation factor|-0.21666||||0.6063|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.6063
71780231|NCT01681472|143059706|OTHER||Correlation factor|0.54039||||0.2105|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.2105
71780232|NCT01681472|143059706|OTHER||Correlation factor|0.27618||||0.5079|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5079
71666616|NCT05534061|142847723|SUPERIORITY||Odds Ratio (OR)|3.96||||0.008|TWO_SIDED|95.0|1.43|10.94||A priori threshold for statistical significance was p\<.05.|Regression, Logistic|A multilevel logistic regression model was specified.|Contingency Management Alone coded as the reference group.|||10.94|1.43|.008
71666617|NCT04138823|142847838|OTHER||Probability of DLT rate in [0.16,0.33)|0.172|||||||||||Bayesian logistic regression model|||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71747967|NCT04879628|143004710|SUPERIORITY||Rate ratio|0.21|||||TWO_SIDED|95.0|0.08|0.56||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.56|0.08|
71747968|NCT04879628|143004710|SUPERIORITY||Rate ratio|0.11|||||TWO_SIDED|95.0|0.03|0.38||||||Negative binomial regression model adjusting for the categorical baseline GdE T1 lesion count (presence/absence) as covariate, treatment as factor, with offset equal to the log of the duration (in months) between the Week 12 MRI and previous MRI at Week 8.||0.38|0.03|
71666618|NCT04138823|142847838|OTHER||Probability of DLT rate in [0.33, 1.00]|0.01||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71780233|NCT01681472|143059706|OTHER||Correlation factor|0.68223||||0.0913|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.0913
71780234|NCT01681472|143059707|OTHER||Correlation factor|0.38298||||0.3964|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.3964
71780235|NCT01681472|143059707|OTHER||Correlation factor|0.27018||||0.5175|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.5175
71780236|NCT01681472|143059707|OTHER||Correlation factor|-0.02188||||0.959|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor||||0.9590
71747992|NCT03069352|143004867|SUPERIORITY||Hazard Ratio (HR)|0.749||||0.114|TWO_SIDED|95.0|0.524|1.071|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||1.071|0.524|0.114
71747993|NCT03069352|143004867|SUPERIORITY||Hazard Ratio (HR)|0.743||||0.103|TWO_SIDED|95.0|0.521|1.061|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.061|0.521|0.103
71747994|NCT03069352|143004868|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71747995|NCT03069352|143004868|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71747996|NCT03069352|143004869|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71747997|NCT03069352|143004869|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71747998|NCT03069352|143004870|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71747999|NCT03069352|143004870|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71748000|NCT03069352|143004871|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71748001|NCT03069352|143004871|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71780237|NCT01681472|143059707|OTHER||Correlation factor|0.45404||||0.3061|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3061
71780238|NCT01681472|143059707|OTHER||Correlation factor|0.34905||||0.3967|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3967
71780239|NCT01681472|143059707|OTHER||Correlation factor|0.07937||||0.8518|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.8518
71780240|NCT01681472|143059708|OTHER||Correlation factor|0.73743||||0.0586|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0586
71780241|NCT01681472|143059708|OTHER||Correlation factor|0.44757||||0.2661|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.2661
71780242|NCT01681472|143059708|OTHER||Correlation factor|0.03292||||0.9506|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.9506
71780243|NCT01681472|143059708|OTHER||Correlation factor|0.09033||||0.8315|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8315
71666619|NCT04138823|142847838|OTHER||Probabilty of DLT rate in [0.16, 0.33)|0.362||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71748002|NCT03069352|143004872|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||<0.001
71748003|NCT03069352|143004872|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71780244|NCT01681472|143059708|OTHER||Correlation factor|0.76502||||0.0451|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in adjacent mucosa||||0.0451
71780245|NCT01681472|143059708|OTHER||Correlation factor|0.34496||||0.4027|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.4027
71780246|NCT01681472|143059708|OTHER||Correlation factor|-0.66295||||0.1513|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.1513
71780247|NCT01681472|143059708|OTHER||Correlation factor|0.36854||||0.369|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.3690
71780248|NCT01681472|143059709|OTHER||Correlation factor|0.23512||||0.5751|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.5751
71666620|NCT04138823|142847838|OTHER||Probability of DLT rate in [0.33, 1.00]|0.046||||||||||||||Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71748004|NCT03069352|143004873|OTHER||LS Mean Difference|-4.507|STANDARD_ERROR_OF_MEAN|2.068|||TWO_SIDED|95.0|-8.6|-0.41|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3, Day 1||-0.41|-8.60|
71748005|NCT03069352|143004873|OTHER||LS Mean Difference|-4.923|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|95.0|-10.03|0.19|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||0.19|-10.03|
71780249|NCT01681472|143059709|OTHER||Correlation factor|0.02576||||0.9672|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa||||0.9672
71780250|NCT01681472|143059709|OTHER||Correlation factor|0.68778||||0.0594|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.0594
71891401|NCT01431287|143304554|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.148|TWO_SIDED|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.046|-0.007|0.1480
71748006|NCT03069352|143004873|OTHER||LS Mean Difference|-0.807|STANDARD_ERROR_OF_MEAN|2.609|||TWO_SIDED|95.0|-5.98|4.36|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||4.36|-5.98|
71748007|NCT03069352|143004873|OTHER||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|3.176|||TWO_SIDED|95.0|-7.94|4.64|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 day 1||4.64|-7.94|
71780251|NCT01681472|143059709|OTHER||Correlation factor|0.11512||||0.8281|TWO_SIDED||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor||||0.8281
71780252|NCT01681472|143059710|OTHER|||||||0.0451|||||||pearson|||||||0.0451
71780253|NCT01681472|143059711|OTHER||Correlation factor|0.42972||||0.3359|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.3359
71780254|NCT01681472|143059711|OTHER||Correlation factor|0.75404||||0.0307|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.0307
71780255|NCT01681472|143059711|OTHER||Correlation factor|-0.7073||||0.116|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.1160
71780256|NCT01681472|143059711|OTHER||Correlation factor|-0.47193||||0.2377|TWO_SIDED||||||Pearson Correlation|||Correlation for AMT gene expression||||0.2377
71780257|NCT01681472|143059711|OTHER||Correlation factor|0.88128||||0.0087|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0087
71780258|NCT01681472|143059711|OTHER||Correlation factor|0.58502||||0.1277|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.1277
71780259|NCT01681472|143059711|OTHER||Correlation factor|0.89976||||0.0146|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.0146
71780260|NCT01681472|143059711|OTHER||Correlation factor|0.11497||||0.7863|TWO_SIDED||||||Pearson Correlation|||Correlation for PCFT gene expression||||0.7863
71780261|NCT01681472|143059711|OTHER||Correlation factor|0.97624||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0002
71891402|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.040|<0.0001
71891403|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.005|TWO_SIDED|95.0|0.011|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.011|0.0050
71780262|NCT01681472|143059711|OTHER||Correlation factor|0.88682||||0.0033|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.0033
71780263|NCT01681472|143059711|OTHER||Correlation factor|-0.64743||||0.1645|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.1645
71780264|NCT01681472|143059711|OTHER||Correlation factor|0.17664||||0.6756|TWO_SIDED||||||Pearson Correlation|||Correlation for FPGS gene expression||||0.6756
71780265|NCT01681472|143059711|OTHER||Correlation factor|0.94364||||0.0014|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0014
71666621|NCT04138823|142847838|OTHER||Probability of DLT rate in [0.16, 0.33)|0.478||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
71780266|NCT01681472|143059711|OTHER||Correlation factor|0.43194||||0.2852|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2852
71780267|NCT01681472|143059711|OTHER||Correlation factor|0.58419||||0.2234|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.2234
71780268|NCT01681472|143059711|OTHER||Correlation factor|0.9584||||0.0002|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFS gene expression||||0.0002
71780269|NCT01681472|143059711|OTHER||Correlation factor|-0.38987||||0.3873|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.3873
71780270|NCT01681472|143059711|OTHER||Correlation factor|-0.25891||||0.5358|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.5358
71780271|NCT01681472|143059711|OTHER||Correlation factor|0.777||||0.0691|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.0691
71780272|NCT01681472|143059711|OTHER||Correlation factor|0.00322||||0.994|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC3 gene expression||||0.9940
71780273|NCT01681472|143059711|OTHER||Correlation factor|0.93711||||0.0018|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0018
71780274|NCT01681472|143059711|OTHER||Correlation factor|0.46883||||0.2413|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.2413
71780275|NCT01681472|143059711|OTHER||Correlation factor|-0.09737||||0.8544|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.8544
71780276|NCT01681472|143059711|OTHER||Correlation factor|0.78928||||0.0199|TWO_SIDED||||||Pearson Correlation|||Correlation for GGH gene expression||||0.0199
71835095|NCT01631214|143174818|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.11||0.005|TWO_SIDED|95.0|0.59|0.91|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.91|0.59|0.005
71780277|NCT01681472|143059711|OTHER||Correlation factor|0.82963||||0.0209|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0209
71780278|NCT01681472|143059711|OTHER||Correlation factor|-0.16724||||0.6922|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.6922
71780279|NCT01681472|143059711|OTHER||Correlation factor|0.14436||||0.785|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.7850
71780280|NCT01681472|143059711|OTHER||Correlation factor|0.74757||||0.033|TWO_SIDED||||||Pearson Correlation|||Correlation for ABCC1 gene expression||||0.0330
71780281|NCT01681472|143059711|OTHER||Correlation factor|0.32113||||0.4825|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.4825
71780282|NCT01681472|143059711|OTHER||Correlation factor|0.3716||||0.3647|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.3647
71780283|NCT01681472|143059711|OTHER||Correlation factor|0.20955||||0.6903|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.6903
71780284|NCT01681472|143059711|OTHER||Correlation factor|0.74459||||0.0341|TWO_SIDED||||||Pearson Correlation|||Correlation for MTHFD1L gene expression||||0.0341
71780285|NCT01681472|143059711|OTHER||Correlation factor|0.50966||||0.2426|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.2426
71780286|NCT01681472|143059711|OTHER||Correlation factor|0.67853||||0.0643|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.0643
71780287|NCT01681472|143059711|OTHER||Correlation factor|0.05531||||0.9171|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.9171
71780288|NCT01681472|143059711|OTHER||Correlation factor|0.59183||||0.1222|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT1 gene expression||||0.1222
71780289|NCT01681472|143059711|OTHER||Correlation factor|0.8104||||0.0271|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0271
71780290|NCT01681472|143059711|OTHER||Correlation factor|0.86266||||0.0058|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.0058
71780291|NCT01681472|143059711|OTHER||Correlation factor|-0.71666||||0.109|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1090
71780292|NCT01681472|143059711|OTHER||Correlation factor|0.55508||||0.1533|TWO_SIDED||||||Pearson Correlation|||Correlation for SHMT2 gene expression||||0.1533
71780293|NCT01681472|143059711|OTHER||Correlation factor|0.318||||0.487|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.4870
71780294|NCT01681472|143059711|OTHER||Correlation factor|0.23312||||0.5785|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.5785
71780295|NCT01681472|143059711|OTHER||Correlation factor|-0.0245||||0.9632|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.9632
71780296|NCT01681472|143059711|OTHER||Correlation factor|0.64565||||0.0838|TWO_SIDED||||||Pearson Correlation|||Correlation for RFC-1 gene expression||||0.0838
71780297|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 0.5 hour post-dose||3.64|-0.7|
71666622|NCT04138823|142847838|OTHER||Probability of DLT rate in [0.33, 1.00]|0.118||||||||||||||"Probability of DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.~The 200 mg BI 891065 BID dose was modelled as equivalent to a 300 mg QD dose in terms of dose-toxicity relationship."||||
71666623|NCT02466685|142847855|SUPERIORITY||Mean Difference (Final Values)|5.0|STANDARD_DEVIATION|9.4|<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
71666624|NCT02391987|142847860|SUPERIORITY|||||||0.73|||||||Cochran-Mantel-Haenszel|||||||0.73
71748008|NCT03069352|143004873|SUPERIORITY|||||||0.126|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.126
71748009|NCT03069352|143004874|OTHER||LS Mean Difference|2.917|STANDARD_ERROR_OF_MEAN|4.617|||TWO_SIDED|95.0|-6.23|12.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3 Day 1||12.06|-6.23|
71748010|NCT03069352|143004874|OTHER||LS Mean Difference|13.388|STANDARD_ERROR_OF_MEAN|5.659|||TWO_SIDED|95.0|2.18|24.59|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1||24.59|2.18|
71748011|NCT03069352|143004874|OTHER||LS Mean Difference|7.119|STANDARD_ERROR_OF_MEAN|6.031|||TWO_SIDED|95.0|-4.83|19.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1||19.06|-4.83|
71748012|NCT03069352|143004874|OTHER||LS Mean Difference|6.381|STANDARD_ERROR_OF_MEAN|7.511|||TWO_SIDED|95.0|-8.49|21.26|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 Day 1||21.26|-8.49|
71780298|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||||90.0|-5.13|-0.79||||||Inferential analysis at 1 hour post-dose||-0.79|-5.13|
71780299|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53||||||90.0|-7.7|-3.36||||||Inferential analysis at 2 hour post-dose||-3.36|-7.70|
71666625|NCT02391987|142847861|SUPERIORITY|||||||0.98|||||||Cochran-Mantel-Haenszel|||||||0.98
71666626|NCT02391987|142847862|SUPERIORITY|||||||0.37|||||||Fisher Exact|||||||0.37
71666627|NCT04739800|142847891|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.44|2.31|||||This is the Hazard Ratio of Group 2 compared to Group 1.|||2.31|0.44|
71666628|NCT04739800|142847891|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.52|2.84|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||2.84|0.52|
71666629|NCT04739800|142847891|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||||This is the Hazard Ratio of Group 4 compared to Group 1.|3.08|0.58|
71748013|NCT03069352|143004874|SUPERIORITY|||||||0.085|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-\< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.||||0.085
71748014|NCT03069352|143004875|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.002|TWO_SIDED|95.0|0.416|0.817|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.817|0.416|0.002
71666630|NCT04739800|142847894|EQUIVALENCE|This is the Hazard Ratio of Group 2 compared to Group 1.|Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.44|4.47|||||This is the Hazard Ratio for Group 2 compared to Group 1.|||4.47|0.44|
71666631|NCT04739800|142847894|EQUIVALENCE|This is the Hazard Ratio of Group 3 compared to Group 1.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.4|4.19|||||This is the Hazard Ratio of Group 3 compared to Group 1.|||4.19|0.40|
71666632|NCT04739800|142847894|EQUIVALENCE|This is the Hazard Ratio of Group 4 compared to Group 1.|Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.58|3.08|||||This is the Hazard Ratio of Group 4 compared to Group 1.|||3.08|0.58|
71666633|NCT01906515|142847902|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71666634|NCT01906515|142847903|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71748015|NCT03069352|143004875|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.003|TWO_SIDED|95.0|0.43|0.839|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||0.839|0.430|0.003
71748016|NCT03069352|143004876|SUPERIORITY||Treatment Difference|22.9||||0.001|TWO_SIDED|95.0|10.8|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||35.0|10.8|0.001
71748017|NCT03069352|143004876|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71748018|NCT03069352|143004877|SUPERIORITY||Treatment Difference|15.2||||0.04|TWO_SIDED|95.0|1.4|29.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo|||29.0|1.4|0.040
71748019|NCT03069352|143004877|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
71780300|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||||90.0|-1.77|2.57||||||Inferential analysis at 4 hour post-dose||2.57|-1.77|
71780301|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||||90.0|-3.54|0.8||||||Inferential analysis at 8 hour post-dose||0.80|-3.54|
71780302|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||||90.0|-1.16|3.18||||||Inferential analysis at 12 hour post-dose||3.18|-1.16|
71780303|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||||90.0|-2.81|1.53||||||Inferential analysis at 24 hour post-dose||1.53|-2.81|
71780304|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49||||||90.0|0.32|4.66||||||Inferential analysis at 0.5 hour post-dose||4.66|0.32|
71891404|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.089|0.039|<0.0001
71748020|NCT03069352|143004878|SUPERIORITY||Treatment Difference|22.4|||||TWO_SIDED|95.0|9.0|35.8||||||||35.8|9.0|
71891405|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.037|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.037|<0.0001
71748021|NCT03069352|143004879|SUPERIORITY||Slope|17.7|||||TWO_SIDED|95.0|-0.4|35.8||||||||35.8|-0.4|
71748022|NCT03069352|143004880|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
71748023|NCT03069352|143004880|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
71748024|NCT03069352|143004881|SUPERIORITY|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).||||||0.162
71748025|NCT03069352|143004881|SUPERIORITY|||||||0.277|||||||Fisher Exact|||||||0.277
71748026|NCT03069352|143004885|OTHER||Hazard Ratio (HR)|0.704||||0.04|TWO_SIDED|95.0|0.503|0.985|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - \< 75, ≥ 75).|||0.985|0.503|0.040
71780305|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||||90.0|-3.95|0.39||||||Inferential analysis at 1 hour post-dose||0.39|-3.95|
71748027|NCT03069352|143004885|OTHER||Hazard Ratio (HR)|0.717||||0.049|TWO_SIDED|95.0|0.514|1.0|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.|||1.000|0.514|0.049
71891406|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0057|TWO_SIDED|95.0|0.01|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.061|0.010|0.0057
71780306|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51||||||90.0|-9.68|-5.34||||||Inferential analysis at 2 hour post-dose||-5.34|-9.68|
71780307|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.47||||||90.0|1.3|5.64||||||Inferential analysis at 4 hour post-dose||5.64|1.30|
71780308|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.13||||||90.0|-1.04|3.3||||||Inferential analysis at 8 hour post-dose||3.30|-1.04|
71780309|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 12 hour post-dose||3.64|-0.70|
71780310|NCT00795145|143059723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||||90.0|-0.37|3.97||||||Inferential analysis at 24 hour post-dose||3.97|-0.37|
71780311|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||||90.0|1.1|5.44||||||Inferential analysis at 0.5 hour post-dose||5.44|1.10|
71780312|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83||||||90.0|4.66|9.0||||||Inferential analysis at 1 hour post-dose||9.00|4.66|
71780313|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.27||||||90.0|8.1|12.44||||||Inferential analysis at 2 hour post-dose||12.44|8.10|
71780314|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.84||||||90.0|7.67|12.01||||||Inferential analysis at 4 hour post-dose||12.01|7.67|
71780315|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||||90.0|7.23|11.58||||||Inferential analysis at 8 hour post-dose||11.58|7.23|
71780316|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||||90.0|4.87|9.22||||||Inferential analysis at 12 hour post-dose||9.22|4.87|
71780317|NCT00795145|143059724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.52||||||90.0|4.35|8.69||||||Inferential analysis at 24 hour post-dose||8.69|4.35|
71780318|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||||90.0|-5.54|2.57||||||Inferential analysis at 0.5 hour post-dose||2.57|-5.54|
71780319|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.45||||||90.0|-11.51|-3.4||||||Inferential analysis at 1 hour post-dose||-3.40|-11.51|
71748044|NCT03062358|143004984|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018|TWO_SIDED|95.0|0.63|0.99||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.99|0.63|0.0180
71748045|NCT03062358|143004985|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0032|TWO_SIDED|95.0|0.6|0.92||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.92|0.60|0.0032
71748046|NCT03062358|143004986|OTHER||Percent Difference|11.4||||4e-05|TWO_SIDED|95.0|6.7|16.0|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. \>= 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|16.0|6.7|0.00004
71748047|NCT03062358|143004988|OTHER||Percent Difference|5.4||||0.13281|TWO_SIDED|95.0|-4.1|14.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|Difference in % vs Placebo|Difference in % vs Placebo|Based on Miettinen \& Nurminen method stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|14.8|-4.1|0.13281
71748048|NCT03062358|143004989|OTHER||Hazard Ratio (HR)|0.72||||0.0019|TWO_SIDED|95.0|0.58|0.9||Log-rank test|One-sided p-value|Stratified by macrovascular invasion, α-Fetoprotein and region with all cells that correspond to macrovascular invasion=Yes combined|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||Stratified by macrovascular invasion (Yes vs. No), α-Fetoprotein (ng/mL) (\< 200 vs. ≥ 200) and region (China vs. ex-China) with all cells that correspond to macrovascular invasion=Yes combined.|0.90|0.58|0.0019
71748049|NCT03861273|143004992|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Mean Difference (Final Values)|-3.13||||0.0081|TWO_SIDED|95.0|-5.44|-0.81|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.81|-5.44|0.0081
71748050|NCT03861273|143004993|NON_INFERIORITY|A repeated measure negative binomial regression model was used to do the hypothesis test on non-inferiority with one-sided test.|Median Difference (Final Values)|-2.62||||0.0019|TWO_SIDED|95.0|-4.27|-0.96|||Generalized linear model (GLM)|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.||||-0.96|-4.27|0.0019
71748051|NCT03861273|143004994|SUPERIORITY||Mean Difference (Final Values)|-54.37|||<|0.0001|TWO_SIDED|95.0|-63.64|-45.1|||Paired t-test|||The treatment difference (PF-06838435 - FIX Prophylaxis) estimate (95% CI) and p-value were obtained from paired t-test.||-45.10|-63.64|<.0001
71748052|NCT03861273|143004995|OTHER||||||<|0.0001||||||P-value from one-sided t-statistic testing the log transformation of the steady state FIX:C \> log(5). Cumulative for 3 assays.|One-sided t-statistic testing|||Week 12 to Month 15||||<.0001
71780320|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.75||||||90.0|-9.81|-1.7||||||Inferential analysis at 2 hour post-dose||-1.70|-9.81|
71748053|NCT03861273|143004997|SUPERIORITY||Mean Difference (Final Values)|-2935.7|||<|0.0001|TWO_SIDED|95.0|-3403.1|-2468.3|||Paired t-test|||||-2468.30|-3403.10|<.0001
71748054|NCT03861273|143004998|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-2.55||||0.0191|TWO_SIDED|95.0|-4.67|-0.42|||Generalized linear model (GLM)|||||-0.42|-4.67|0.0191
71748055|NCT03861273|143004999|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Median Difference (Final Values)|-0.57||||0.1528|TWO_SIDED|95.0|-1.35|0.21|||Generalized linear model (GLM)|||||0.21|-1.35|0.1528
71748056|NCT03861273|143005000|NON_INFERIORITY|The treatment difference and P-value were obtained from a repeated measures GLM with negative binomial distribution and identity link function.|Mean Difference (Final Values)|-0.51||||0.3738|TWO_SIDED|95.0|-1.63|0.61|||Generalized linear model (GLM)|||||0.61|-1.63|0.3738
71748057|NCT03861273|143005003|OTHER|||||||0.0117|||||||Paired t-test|||||||0.0117
71748058|NCT03861273|143005004|OTHER|||||||0.0052|||||||Paired t-test|||||||0.0052
71748059|NCT03861273|143005005|OTHER|||||||0.0237|||||||Paired t-test|||||||0.0237
71748060|NCT03799341|143005037|OTHER|||||||0.177|||||||Wilcoxon (Mann-Whitney)|||||||0.177
71748061|NCT03799341|143005038|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||||||0.033
71748062|NCT03799341|143005039|OTHER|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
71748063|NCT03799341|143005040|OTHER|||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
71748064|NCT03799341|143005041|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
71748065|NCT03799341|143005042|OTHER|||||||0.976|||||||Wilcoxon (Mann-Whitney)|||||||0.976
71748066|NCT03799341|143005043|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.920
71748067|NCT03799341|143005044|OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||||||0.873
71780321|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||||90.0|-4.97|3.13||||||Inferential analysis at 4 hour post-dose||3.13|-4.97|
71780322|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64||||||90.0|-9.69|-1.58||||||Inferential analysis at 8 hour post-dose||-1.58|-9.69|
71780323|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||||90.0|-6.34|1.77||||||Inferential analysis at 12 hour post-dose||1.77|-6.34|
71780324|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||||90.0|-4.64|3.47||||||Inferential analysis at 24 hour post-dose||3.47|-4.64|
71780325|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49||||||90.0|-7.54|0.57||||||Inferential analysis at 0.5 hour post-dose||0.57|-7.54|
71780326|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.19||||||90.0|-16.24|-8.13||||||Inferential analysis at 1 hour post-dose||-8.13|-16.24|
71780327|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.39||||||90.0|-18.44|-10.33||||||Inferential analysis at 2 hour post-dose||-10.33|-18.44|
71780328|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||||90.0|-6.24|1.87||||||Inferential analysis at 4 hour post-dose||1.87|-6.24|
71780329|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||||90.0|-2.95|5.15||||||Inferential analysis at 8 hour post-dose||5.15|-2.95|
71780330|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||||90.0|-3.94|4.17||||||Inferential analysis at 12 hour post-dose||4.17|-3.94|
71780331|NCT00795145|143059725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||||90.0|-1.37|6.73||||||Inferential analysis at 24 hour post-dose||6.73|-1.37|
71780332|NCT04092582|143059751|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6835|TWO_SIDED|95.0|0.55|1.47|||Regression, Cox|||||1.47|0.55|0.6835
71780333|NCT04092582|143059752|SUPERIORITY||Rate Ratio|1.0989||||0.7648|TWO_SIDED|95.0|0.5925|2.0381|||Poisson regression|||||2.0381|0.5925|0.7648
71780334|NCT04092582|143059753|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.5248|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|||||1.54|0.43|0.5248
71780335|NCT04092582|143059754|SUPERIORITY|||||||0.125|||||||Mixed model for repeated measures (MMRM)|||||||0.1250
71780336|NCT04092582|143059755|SUPERIORITY|||||||0.2249|||||||Mixed model for repeated measures (MMRM)|||||||0.2249
71780337|NCT04092582|143059756|SUPERIORITY|||||||0.9693|||||||Mixed model for repeated measures (MMRM)|||||||0.9693
71780338|NCT04092582|143059757|SUPERIORITY|||||||0.9855|||||||Mixed model for repeated measures (MMRM)|||||||0.9855
71780339|NCT00739674|143059816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.118||95.0|||||Fisher Exact|||||||0.118
71780340|NCT00739674|143059817|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
71780341|NCT00739674|143059818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
71780342|NCT00739674|143059819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||95.0|||||Fisher Exact|||||||0.434
71780343|NCT00739674|143059820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.507||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.507
71780344|NCT00739674|143059821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.058
71780345|NCT00739674|143059822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.158
71780346|NCT00739674|143059823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.064
71780347|NCT00739674|143059824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.262
71780348|NCT00739674|143059825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.||||||0.026
71780349|NCT00739674|143059826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212||95.0|||||Log Rank|||||||0.212
71780350|NCT00283400|143059849|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.05|||<|0.05|TWO_SIDED|95.0|0.65|14.1|||Mixed Models Analysis|Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.||||14.1|0.65|<0.05
71780351|NCT01034631|143059853|OTHER|||||||0.6625|||||||Chi-squared|||||||.6625
71780352|NCT01890473|143059889|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.908|||||TWO_SIDED|90.0|0.815|1.01||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale (using log (Cmax) without a formal test.||1.01|0.815|
71780353|NCT01890473|143059890|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.941|||||TWO_SIDED|90.0|0.843|1.05||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log (AUC (0-T) without a formal test.||1.05|0.843|
71780354|NCT01890473|143059891|SUPERIORITY_OR_OTHER||ratio of geometric mean|0.976|||||TWO_SIDED|90.0|0.888|1.07||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log AUC(INF) without a formal test.||1.07|0.888|
71780355|NCT03166735|143059904|OTHER||Predicted mean daily dose in mg|3.45|STANDARD_ERROR_OF_MEAN|0.1|||||||||non-linear regression||The model fit used power of mean variance estimates (POM) to account for heterogeneity.|D10: Estimated dose reaching \<=10% activity the first time.||||
71780356|NCT03166735|143059906|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0212||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0212
71780357|NCT03166735|143059907|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.127||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1270
71780358|NCT03166735|143059908|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.3324||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.3324
71780359|NCT03166735|143059909|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.129||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.1290
71677006|NCT01683266|142872378|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.322|||TWO_SIDED|95.0|-0.982|0.287||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.||0.287|-0.982|
71748068|NCT03799341|143005045|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
71748069|NCT03799341|143005045|OTHER||||||<|0.001|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), stimulus condition (3 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||<0.001
71748070|NCT03799341|143005045|OTHER|||||||0.022|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the influence of Contingency Management session attendance. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.022
71748071|NCT03799341|143005045|OTHER|||||||0.024|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit covariates. A median split approach was therefore used to examine the influence of self-reported cocaine abstinence during treatment. The design included 4 factors: time (2 levels), response accuracy (2 levels), electrode pair (4 levels), and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.024
71748072|NCT03799341|143005046|OTHER|||||||0.973|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of Contingency Management session attendance. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.973
71748073|NCT03799341|143005046|OTHER|||||||0.662|||||||ANOVA|||No violations of normality assumptions were identified. A repeated measures ANOVA was conducted. To maintain consistency with other outcome measures, a median split approach was used to examine the potential influence of self-reported cocaine abstinence during the 12-week treatment interval. The design included two factors: time (2 levels) and median split group membership (2 levels). Reported results reflect the interaction between time and median split group.||||0.662
71748074|NCT03799341|143005047|OTHER|||||||0.878|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of Contingency Management session attendance. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.878
71748075|NCT03799341|143005047|OTHER|||||||0.645|||||||ANOVA|||Due to violations of normality assumptions, a non-parametric Aligned Rank Transform ANOVA was conducted, which does not permit inclusion of covariates. A median split approach was therefore used to examine the potential influence of self-reported cocaine abstinence during treatment. The design included 3 factors: time (2 levels), condition (2 levels), and median split group membership (2 levels). Reported results reflect the interaction between time, condition, and median split group.||||0.645
71780360|NCT03166735|143059910|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0042||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod Sigmoidal Emax model fit.|30% of the maximum effect is achieved at 3 mg and 90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0042
71780361|NCT03166735|143059911|OTHER|The MMRM included fixed effects for 'base', 'treatment', 'time', 'base\*time' interaction, and 'treatment\*time' interaction. Estimates were used to test dose-response relationship using MCPMod.||||||0.0728||||||p\<0.05 is a significant test result (rejecting the null hypothesis of a flat dose-response curve) with alpha 0.05, one-sided.|MCPMod exponential model fit.|90% of the maximum effect is achieved at 7 mg of BI 1467335||||||0.0728
71780362|NCT01519271|143059938|SUPERIORITY||Cohen's D|0.35|||||TWO_SIDED|||||||||||||
71780363|NCT01292746|143059939|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|2 sided t-test for correlated samples.||||||<0.05
71780364|NCT04572633|143059974|OTHER||Wilson Score|95.5|||||TWO_SIDED|95.0|83.72|100.0|||||Bootstrap sampling with replacement method to account for potential within-subject lesion correlations. Subject is the bootstrap sampling unit, 1,000,000 iterations for bootstrap resampling, and the bias-corrected and accelerated method was used.|||100|83.72|
71780365|NCT04572633|143059975|OTHER||Wilson Score|6.8|||||TWO_SIDED|95.0|2.35|18.23||||||||18.23|2.35|
71780366|NCT03570697|143060126|SUPERIORITY||Treatment difference|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.015|TWO_SIDED|95.0|4.7|37.7|||ANCOVA|||||37.7|4.7|0.015
71780367|NCT03570697|143060127|SUPERIORITY||Treatment difference|37.47|STANDARD_ERROR_OF_MEAN|17.04||0.041|TWO_SIDED|95.0|1.63|73.31|||ANCOVA|||||73.31|1.63|0.041
71780368|NCT03570697|143060128|SUPERIORITY||Treatment difference|32.51|STANDARD_ERROR_OF_MEAN|9.52||0.003|TWO_SIDED|95.0|12.67|52.35|||ANCOVA|||||52.35|12.67|0.003
71780369|NCT03570697|143060129|SUPERIORITY||Treatment difference|-26.0|STANDARD_ERROR_OF_MEAN|11.4||0.032|TWO_SIDED|95.0|-49.6|-2.4|||ANCOVA|||||-2.4|-49.6|0.032
71780370|NCT03570697|143060130|SUPERIORITY||Treatment difference|16.0|STANDARD_ERROR_OF_MEAN|7.5||0.036|TWO_SIDED|95.0|1.1|31.0|||ANCOVA|||||31.0|1.1|0.036
71666635|NCT06360081|142847911|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|99.89|||<|0.0001|TWO_SIDED|90.0|97.08|102.78||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 9.0%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||102.78|97.08|<0.0001
71666636|NCT06360081|142847912|EQUIVALENCE|The assessment of bioequivalence was based on two-sided 90% CIs for the ratios of the geometric means (gMean) (T/R) using an acceptance range of 80.0 to 125.0%.|Ratio of adjusted geometric means (T/R)|100.83|||<|0.0001|TWO_SIDED|90.0|96.43|105.44||p-value was calculated for ratios outside the 80.0 to 125.0% interval.|ANOVA||Ratio as percentage \[%\] Intra-individual geometric coefficient of variation (gCV) = 14.2%.|PK endpoints were back transformed to the original scale to provide the point estimate and 90% confidence intervals (CIs) for each endpoint. The model included effects accounting for variation in sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the others were considered as fixed. Confidence intervals were calculated based on the residual error from the ANOVA.||105.44|96.43|<0.0001
71748078|NCT01116648|143005070|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED||||||||Cediranib|||||
71748079|NCT01116648|143005070|OTHER||Maximum Tolerated Dose (mg BID)|200.0|||||TWO_SIDED||||||||Olaparib|||||
71780371|NCT03570697|143060131|SUPERIORITY||Treatment difference|-30.0|STANDARD_ERROR_OF_MEAN|10.4||0.005|TWO_SIDED|95.0|-50.5|-9.5|||ANCOVA|||||-9.5|-50.5|0.005
71666637|NCT02454608|142847941|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71666638|NCT02454608|142847942|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71666639|NCT02454608|142847943|SUPERIORITY_OR_OTHER|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71748080|NCT01116648|143005072|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.006|TWO_SIDED|95.0|0.3|0.83|||Kaplan-Meier Plot|||||0.83|0.30|0.006
71780372|NCT03570697|143060132|SUPERIORITY||Treatment difference|-2.43|STANDARD_ERROR_OF_MEAN|0.81||0.003|TWO_SIDED|95.0|-4.04|-0.82|||ANCOVA|||||-0.82|-4.04|0.003
71666640|NCT02454608|142847944|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71666641|NCT02454608|142847945|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
71666642|NCT02454608|142847946|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
71666643|NCT02454608|142847947|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.7
71780373|NCT03948581|143060157|EQUIVALENCE|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with group, treatment, and injection site as fixed effects and weight as a continuous covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9807|||||TWO_SIDED|90.0|0.9011|1.0675||||||||1.0675|0.9011|
71780374|NCT03948581|143060158|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9981|||||TWO_SIDED|90.0|0.9223|1.0801||||||||1.0801|0.9223|
71666644|NCT00486525|142848003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|STANDARD_ERROR_OF_MEAN|0.058||0.2|TWO_SIDED|95.0|-0.19|0.039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.039|-0.19|0.20
71780375|NCT03948581|143060159|EQUIVALENCE|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with group, treatment, and injection site as fixed effects and weight as a continuous covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0038|||||TWO_SIDED|90.0|0.9401|1.0719||||||||1.0719|0.9401|
71780376|NCT01172522|143060177|SUPERIORITY_OR_OTHER||Other|0.0|||=|1|TWO_SIDED||||||Chi-squared||P values above 0.05 is considered statistically insignificant in this study.|||||=1
71748097|NCT03100149|143005133|SUPERIORITY||Difference in Adjusted Means|-2.02|STANDARD_ERROR_OF_MEAN|1.71||0.2385|TWO_SIDED|80.0|-4.21|0.18|||Mixed Models Analysis|||||0.18|-4.21|0.2385
71666645|NCT00486525|142848003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.027|TWO_SIDED|95.0|-0.25|-0.015|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.015|-0.25|0.027
71748098|NCT03100149|143005133|SUPERIORITY||Difference in Adjusted Means|-0.62|STANDARD_ERROR_OF_MEAN|1.71||0.7169|TWO_SIDED|80.0|-2.82|1.58|||Mixed Models Analysis|||||1.58|-2.82|0.7169
71748099|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6116|TWO_SIDED|80.0|-0.3|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.13|-0.30|0.6116
71748100|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|0.165||0.6188|TWO_SIDED|80.0|-0.13|0.3||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IA||0.30|-0.13|0.6188
71748101|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.04|STANDARD_ERROR_OF_MEAN|0.345||0.9062|TWO_SIDED|80.0|-0.48|0.4||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.40|-0.48|0.9062
71748102|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.347||0.9621|TWO_SIDED|80.0|-0.43|0.46||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part IB||0.46|-0.43|0.9621
71748103|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.411||0.651|TWO_SIDED|80.0|-0.71|0.34||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.34|-0.71|0.6510
71780377|NCT00578383|143060227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|1.17||0.009|TWO_SIDED|95.0|0.5|5.8||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||5.8|0.5|0.009
71780378|NCT00578383|143060228|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.06|STANDARD_ERROR_OF_MEAN|0.38||0.006|TWO_SIDED|95.0|0.2|1.9||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.||1.9|0.2|0.006
71780379|NCT00578383|143060229|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|1.24||0.001|TWO_SIDED|95.0|1.3|6.9||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).||6.9|1.3|0.001
71780380|NCT00578383|143060230|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.39||0.15|TWO_SIDED|95.0|-1.1|5.1||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)||5.1|-1.1|0.15
71780381|NCT00578383|143060231|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.09|TWO_SIDED|95.0|-1.2|6.2||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.||6.2|-1.2|0.09
71780382|NCT00578383|143060232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|2.11||0.19|TWO_SIDED|95.0|-3.3|9.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.||9.6|-3.3|0.19
71891407|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.013||0.9633|TWO_SIDED|95.0|-0.025|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.026|-0.025|0.9633
71748104|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.413||0.7709|TWO_SIDED|80.0|-0.41|0.65||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part I Total||0.65|-0.41|0.7709
71748105|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|0.34|STANDARD_ERROR_OF_MEAN|0.523||0.5177|TWO_SIDED|80.0|-0.33|1.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||1.01|-0.33|0.5177
71748106|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.06|STANDARD_ERROR_OF_MEAN|0.523||0.9095|TWO_SIDED|80.0|-0.73|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part II Total||0.61|-0.73|0.9095
71748107|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-1.88|STANDARD_ERROR_OF_MEAN|1.255||0.1354|TWO_SIDED|80.0|-3.49|-0.27||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||-0.27|-3.49|0.1354
71748108|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-1.02|STANDARD_ERROR_OF_MEAN|1.262||0.4217|TWO_SIDED|80.0|-2.64|0.61||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Total||0.61|-2.64|0.4217
71748109|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.369||0.8053|TWO_SIDED|80.0|-0.38|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.56|-0.38|0.8053
71748110|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.37||0.497|TWO_SIDED|80.0|-0.22|0.73||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Rigidity||0.73|-0.22|0.4970
71748111|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-1.07|STANDARD_ERROR_OF_MEAN|0.779||0.1703|TWO_SIDED|80.0|-2.07|-0.07||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||-0.07|-2.07|0.1703
71748112|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.44|STANDARD_ERROR_OF_MEAN|0.782||0.5729|TWO_SIDED|80.0|-1.45|0.56||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Bradykinesia||0.56|-1.45|0.5729
71748113|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.61|STANDARD_ERROR_OF_MEAN|0.324||0.0628|TWO_SIDED|80.0|-1.02|-0.19||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||-0.19|-1.02|0.0628
71748114|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.41|STANDARD_ERROR_OF_MEAN|0.325||0.2125|TWO_SIDED|80.0|-0.82|0.01||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Resting Tremor||0.01|-0.82|0.2125
71748115|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4577|TWO_SIDED|80.0|-0.22|0.06||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.06|-0.22|0.4577
71677007|NCT01062113|142872417|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|38.2|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|20.3|56.1||The difference in the efficacy rates was tested using normal distribution at a significance level of 2-sided 5%. 2-sided 95% confidence interval (CI) for the difference in the efficacy rates was calculated using normal approximation.|asymptotic z-test|||||56.1|20.3|<0.0001
71748116|NCT03100149|143005134|SUPERIORITY||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.109||0.9182|TWO_SIDED|80.0|-0.15|0.13||Nominal p-values are displayed for descriptive purposes only.|Mixed Models Analysis|||MDS-UPDRS Part III Subscore: Axial Symptoms||0.13|-0.15|0.9182
71748117|NCT03100149|143005135|SUPERIORITY||LS Means Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3582|TWO_SIDED|80.0|-0.05|0.01||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.01|-0.05|0.3582
71748118|NCT03100149|143005135|SUPERIORITY||LS Means Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.1955|TWO_SIDED|80.0|-0.06|0.0||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.00|-0.06|0.1955
71748119|NCT03100149|143005136|SUPERIORITY||Difference in Adjusted Means|0.22|STANDARD_ERROR_OF_MEAN|0.245||0.3611|TWO_SIDED|80.0|-0.09|0.54||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.54|-0.09|0.3611
71748120|NCT03100149|143005136|SUPERIORITY||Difference in Adjusted Means|0.44|STANDARD_ERROR_OF_MEAN|0.243||0.0727|TWO_SIDED|80.0|0.13|0.75||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.75|0.13|0.0727
71748121|NCT03100149|143005137|SUPERIORITY||Odds Ratio (OR)|0.77||||0.4265|TWO_SIDED|80.0|0.5|1.18||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.18|0.50|0.4265
71748122|NCT03100149|143005137|SUPERIORITY||Odds Ratio (OR)|0.76||||0.4063|TWO_SIDED|80.0|0.49|1.16||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.16|0.49|0.4063
71748123|NCT03100149|143005138|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3847|TWO_SIDED|80.0|0.48|1.15||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.15|0.48|0.3847
71748124|NCT03100149|143005138|SUPERIORITY||Odds Ratio (OR)|0.88||||0.7055|TWO_SIDED|80.0|0.57|1.36||Nominal p-values are displayed for descriptive purposes only.|Regression, Logistic|||||1.36|0.57|0.7055
71748125|NCT03100149|143005139|SUPERIORITY||Difference in Adjusted Means|-0.73|STANDARD_ERROR_OF_MEAN|0.888||0.4142|TWO_SIDED|80.0|-1.87|0.41||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.41|-1.87|0.4142
71748126|NCT03100149|143005139|SUPERIORITY||Difference in Adjusted Means|-0.67|STANDARD_ERROR_OF_MEAN|0.885||0.4486|TWO_SIDED|80.0|-1.81|0.47||Nominal p-values are displayed for descriptive purposes only.|ANCOVA|||||0.47|-1.81|0.4486
71748127|NCT03100149|143005140|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3769|TWO_SIDED|80.0|0.94|1.42||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.42|0.94|0.3769
71677008|NCT01062113|142872419|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71748128|NCT03100149|143005140|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.1658|TWO_SIDED|80.0|1.02|1.53||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.53|1.02|0.1658
71748129|NCT03100149|143005141|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9542|TWO_SIDED|80.0|0.77|1.33||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.33|0.77|0.9542
71748130|NCT03100149|143005141|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4567|TWO_SIDED|80.0|0.63|1.13||Nominal p-values are displayed for descriptive purposes only.|Regression, Cox|||||1.13|0.63|0.4567
71780383|NCT00578383|143060233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.51||0.15|TWO_SIDED|95.0|-0.6|2.1||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.||2.1|-0.6|0.15
71891408|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.038|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.088|0.038|<0.0001
71748179|NCT04972162|143005230|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.38||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Ease of Communication Subscale (EC)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.38
71748180|NCT04972162|143005230|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.79||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Background Noise Subscale (BN)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.79
71748181|NCT04972162|143005230|OTHER|The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.||||||0.51||||||p\<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids|ANOVA|||"Check for interaction effect for Reverberant Room Subscale (RV)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect."||||0.51
71748182|NCT04972162|143005230|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.44|||<|0.0001|TWO_SIDED|95.0|-4.3|5.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||5.2|-4.3|<0.0001
71748183|NCT04972162|143005230|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.97|||<|0.0001|TWO_SIDED|95.0|-5.3|7.2||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||7.2|-5.3|<0.0001
71758522|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71780384|NCT00578383|143060234|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.67||0.04|TWO_SIDED|95.0|-0.4|3.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.||3.6|-0.4|0.04
71780385|NCT00578383|143060235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|1.67||0.004|TWO_SIDED|95.0|0.8|9.2||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)||9.2|0.8|0.004
71780386|NCT00578383|143060236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.58||0.3|TWO_SIDED|95.0|1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)||5.8|1.3|0.30
71891409|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.013||0.025|TWO_SIDED|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.054|0.004|0.0250
71677009|NCT01062113|142872420|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71748184|NCT04972162|143005230|NON_INFERIORITY|Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox \& Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28|Mean Difference (Final Values)|0.98|||<|0.0001|TWO_SIDED|95.0|-4.6|6.5||Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.|ANOVA|repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order|Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)|Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.||6.5|-4.6|<0.0001
71748185|NCT00336024|143005235|SUPERIORITY|||||||0.35|||||||Chi-squared|||The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.||||0.35
71748186|NCT00336024|143005237|SUPERIORITY|||||||0.2|||||||Log Rank|||The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.||||0.2
71748187|NCT00336024|143005238|SUPERIORITY|||||||1|||||||Fisher Exact|||The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.||||1.00
71748188|NCT00336024|143005239|SUPERIORITY|||||||0.74|||||||Log Rank|||Difference in incidence for the two treatment regimens will be compared using log-rank test.||||0.74
71748189|NCT00336024|143005240|SUPERIORITY|||||||1|||||||Fisher Exact|||The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.||||1.00
71780387|NCT00578383|143060237|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.01||0.52|TWO_SIDED|95.0|-4.1|6.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)||6.8|-4.1|0.52
71780388|NCT00578383|143060238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.43||0.1||95.0|-1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)||5.8|-1.3|0.10
71780389|NCT00181155|143060271|SUPERIORITY_OR_OTHER||||||<|0.007||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.007
71780390|NCT00181155|143060272|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||vs. baseline|Two-sided paired t tests|||||||<0.02
71780391|NCT02012283|143060307|OTHER|paired t-test|Mean Difference (Final Values)|78.4||||0.001|TWO_SIDED|95.0||||p\<0.05 is defined as significant|t-test, 2 sided|||Difference between plain and spiced broccoli intake was compared.||||0.001
71835096|NCT01631214|143174819|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.81|STANDARD_ERROR_OF_MEAN|0.12||0.074|TWO_SIDED|95.0|0.64|1.02|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.02|0.64|0.074
71835097|NCT01631214|143174820|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.24||0.17|TWO_SIDED|95.0|0.46|1.15|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.15|0.46|0.17
71748190|NCT00336024|143005246|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.||||0.8
71748191|NCT00336024|143005247|SUPERIORITY|||||||0.27|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.27
71748192|NCT00336024|143005247|SUPERIORITY|||||||0.07|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.07
71748193|NCT00336024|143005247|SUPERIORITY|||||||0.2|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.2
71748194|NCT00336024|143005247|SUPERIORITY|||||||0.4|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.4
71748195|NCT00336024|143005247|SUPERIORITY|||||||0.38|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.38
71891410|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.013||0.8949|TWO_SIDED|95.0|-0.023|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.027|-0.023|0.8949
71891411|NCT01431287|143304555|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0351|TWO_SIDED|95.0|0.002|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.052|0.002|0.0351
71891412|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.105|0.055|<0.0001
71891413|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.022|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.073|0.022|0.0002
71891414|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.101|0.051|<0.0001
71891415|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.036|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.086|0.036|<0.0001
71748196|NCT00336024|143005247|SUPERIORITY|||||||0.7|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.7
71748197|NCT00336024|143005248|SUPERIORITY|||||||0.08|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.08
71748198|NCT00336024|143005248|SUPERIORITY|||||||0.9|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.9
71780392|NCT02012283|143060308|OTHER|paired t-test|Mean Difference (Final Values)|101.3||||0.031|TWO_SIDED|||||p\<0.05 is defined as significant.|t-test, 2 sided|||Comparison was made to the broccoli intake with and without spices among low restraint eaters vs. the change among high restraint eaters.||||0.031
71891416|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.013||0.0007|TWO_SIDED|95.0|0.018|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.069|0.018|0.0007
71891417|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.013||0.7755|TWO_SIDED|95.0|-0.022|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.029|-0.022|0.7755
71748199|NCT00336024|143005248|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
71748200|NCT00336024|143005248|SUPERIORITY|||||||0.3|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.3
71748201|NCT00336024|143005248|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.26
71748202|NCT00336024|143005248|SUPERIORITY|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.||||0.17
71780393|NCT00289783|143060317|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by Enzyme Linked Immunosorbent Assay (ELISA) the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
71758523|NCT02205736|143019221|SUPERIORITY|||||||0.0588||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0588
71758524|NCT02205736|143019221|SUPERIORITY|||||||0.0143||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0143
71758525|NCT02205736|143019221|SUPERIORITY|||||||0.1025||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1025
71758526|NCT02205736|143019221|SUPERIORITY|||||||0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0001
71835098|NCT01631214|143174821|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.41|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|0.24|0.71|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.71|0.24|<0.001
71835099|NCT01631214|143174822|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.15||0.027|TWO_SIDED|95.0|0.54|0.96|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.96|0.54|0.027
71835100|NCT01631214|143174823|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|0.44|0.89|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values \< 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).|||0.89|0.44|0.008
71758527|NCT02205736|143019221|SUPERIORITY|||||||0.1138||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.1138
71677010|NCT03702010|142872426|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||Baseline VAS||||0.112
71677011|NCT03702010|142872426|SUPERIORITY|||||||0.323|||||||t-test, 2 sided|||After first stimulation VAS||||0.323
71677012|NCT03702010|142872426|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||After second stimulation||||0.760
71780394|NCT00289783|143060317|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.42|0.89|
71780395|NCT00289783|143060317|EQUIVALENCE|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the \[0.5; 2.0\] interval.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.26||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.||1.26|0.8|
71780396|NCT00289783|143060318|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.23|||||TWO_SIDED|95.0|0.93|1.62||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.62|0.93|
71780397|NCT00289783|143060318|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.74|1.29||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.29|0.74|
71780398|NCT00289783|143060318|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.79|||||TWO_SIDED|95.0|0.6|1.04||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).||1.04|0.6|
71780399|NCT00289783|143060319|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.61|||||TWO_SIDED|95.0|1.14|2.27||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||2.27|1.14|
71780400|NCT00289783|143060319|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|1.4|||||TWO_SIDED|95.0|0.99|1.97||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.97|0.99|
71780401|NCT00289783|143060319|EQUIVALENCE|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the \[0.5; 2.0\] interval.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.62|1.21||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).||1.21|0.62|
71780402|NCT00289783|143060320|NON_INFERIORITY|Criteria for immunogenicity of MenC (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|12.0|||||TWO_SIDED|95.0|10.4|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||13.8|10.4|
71835101|NCT01631214|143174823|SUPERIORITY||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.46|0.89|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (\<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, \> -2.5).~Values \< 1 for risk ratio favor romosozumab."||0.89|0.46|
71780403|NCT00289783|143060320|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values)|GMT ratio|1.4|||||TWO_SIDED|95.0|1.4|1.4||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.||1.4|1.4|
71780404|NCT00289783|143060321|NON_INFERIORITY|Criteria for immunogenicity of MenY (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|11.8|||||TWO_SIDED|95.0|10.2|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||13.8|10.2|
71780405|NCT00289783|143060321|NON_INFERIORITY|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).|GMT ratio|21.1|||||TWO_SIDED|95.0|21.1|21.1||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.||21.1|21.1|
71666646|NCT00486525|142848003|SUPERIORITY_OR_OTHER||Slope|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.28|TWO_SIDED|95.0|-0.06|0.018|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.018|-0.060|0.28
71748206|NCT04245111|143005288|OTHER|No other statistical analysis completed other than percentage of patients completed as reported in the data table section||||||||||||||||No other statistical analysis completed other than percentage of patients completed as reported in the data table section|No other statistical analysis completed other than percentage of patients completed as reported in the data table section|||
71748207|NCT03192176|143005289|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.56|-0.25||LS Means(LSM), standard errors(SE), confidence intervals(CI), \& p-values come from an ANCOVA model with CFB as the dependent variable \& treatment group, pooled center, smoking status as factors \& baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.25|-3.56|0.0240
71780406|NCT00289783|143060325|NON_INFERIORITY|Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 150 mIU/mL, in initially seronegative subjects (\<150 mIU/mL), for anti-measles antibody is ≥-5% (clinical limit for non-inferiority).|Difference in percentage|-0.15|||||TWO_SIDED|95.0|-2.56|3.06||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||3.06|-2.56|
71780407|NCT00289783|143060326|NON_INFERIORITY|Criteria for non-inferiority (42 days after the fourth dose): Lower limit of the two-sided standardized asymptotic 95% CI on the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with anti-PRP concentration ≥ 1.0 µg/mL is ≥ -10% (clinical limit for non-inferiority)|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.78|3.57||||||To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.||3.57|-1.78|
71780408|NCT00289783|143060327|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with a seroconversion ≥28 ED50, in subjects with initial anti-mumps antibody \< 28 ED50, for anti-mumps antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|-1.0|||||TWO_SIDED|95.0|-2.16|0.98||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||0.98|-2.16|
71780409|NCT00289783|143060328|NON_INFERIORITY|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroresponse ≥10 IU/ml, in initially seronegative subjects (\< 4 IU/ml), for anti-rubella antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|0.12|||||TWO_SIDED|95.0|-0.57|1.73||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.||1.73|-0.57|
71780410|NCT00289783|143060329|NON_INFERIORITY|Criterion for non-inferiority (42 days after the fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 1:5 dilution, in initially seronegative subjects (\< 1:5), for anti-varicella antibody is ≥ -10% (clinical limit for non-inferiority).|Difference in percentage|-0.14|||||TWO_SIDED|95.0|-0.78|1.56||||||To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).||1.56|-0.78|
71780411|NCT04547712|143060401|SUPERIORITY||Proportion expressed as a percentage|78.9|||||ONE_SIDED|97.5|59.4||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold \> 50%"|||59.4|
71780412|NCT04547712|143060401|SUPERIORITY||Proportion expressed as a percentage|91.0|||||ONE_SIDED|97.5|75.6||||||The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.|"Null Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \<= 50%; Alternative Hypothesis: The proportion of subjects with On time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold \> 50%"|||75.6|
71666647|NCT00486525|142848003|SUPERIORITY_OR_OTHER||Slope|-0.038|STANDARD_ERROR_OF_MEAN|0.02||0.063|TWO_SIDED|95.0|-0.079|0.0021|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0021|-0.079|0.063
71748208|NCT03192176|143005289|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.68|-1.38||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.38|-4.68|0.0004
71780413|NCT04547712|143060402|SUPERIORITY|||||||0.012||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0120
71748209|NCT03192176|143005289|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.001|TWO_SIDED|95.0|-4.44|-1.14||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.14|-4.44|0.0010
71748210|NCT03192176|143005289|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.2|-1.89||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.89|-5.20|<0.0001
71748211|NCT03192176|143005289|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.84||0.0058||95.0|-4.0|-0.68||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.68|-4.00|0.0058
71748212|NCT03192176|143005289|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-4.65|-1.41||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.41|-4.65|0.0003
71748213|NCT03192176|143005289|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0042|TWO_SIDED|95.0|-4.06|0.76||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.76|-4.06|0.0042
71748214|NCT03192176|143005290|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0154|TWO_SIDED|95.0|-3.3|-0.35||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.35|-3.30|0.0154
71748215|NCT03192176|143005290|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.74||0.0043|TWO_SIDED|95.0|-3.6|-0.67||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.67|-3.60|0.0043
71748216|NCT03192176|143005290|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0023|TWO_SIDED|95.0|-3.76|-0.83||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.83|-3.76|0.0023
71748217|NCT03192176|143005290|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0005|TWO_SIDED|95.0|-4.09|-1.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.16|-4.09|0.0005
71748218|NCT03192176|143005290|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0064|TWO_SIDED|95.0|-3.52|-0.58||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.58|-3.52|0.0064
71748219|NCT03192176|143005290|SUPERIORITY||-2.6|-2.6|STANDARD_ERROR_OF_MEAN|0.74||0.0005|TWO_SIDED|95.0|-4.04|-1.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-1.15|-4.04|0.0005
71748220|NCT03192176|143005290|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0063|TWO_SIDED|95.0|-3.52|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-3.52|0.0063
71748221|NCT03192176|143005291|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0215|TWO_SIDED|95.0|-0.84|-0.07||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.07|-0.84|0.0215
71748222|NCT03192176|143005291|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0017|TWO_SIDED|95.0|-1.01|-0.24||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.24|-1.01|0.0017
71748223|NCT03192176|143005291|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.21|-0.44||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.44|-1.21|<0.0001
71748224|NCT03192176|143005291|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.37|-0.59||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.59|-1.37|<0.0001
71748225|NCT03192176|143005291|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0322|TWO_SIDED|95.0|-0.81|-0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.04|-0.81|0.0322
71748226|NCT03192176|143005291|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0017|TWO_SIDED|95.0|-0.99|-0.23||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.23|-0.99|0.0017
71666648|NCT00486525|142848004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.062||0.2|TWO_SIDED|95.0|-0.2|-0.042|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.042|-0.2|0.2
71666649|NCT00486525|142848004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.064||0.015|TWO_SIDED|95.0|-0.28|-0.031|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.031|-0.28|0.015
71666650|NCT00486525|142848004|SUPERIORITY_OR_OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.021||0.3|TWO_SIDED|95.0|-0.063|0.019|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.019|-0.063|0.3
71748227|NCT03192176|143005291|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.08|-0.31||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.31|-1.08|0.0004
71748228|NCT03192176|143005292|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2324|TWO_SIDED|95.0|-0.67|-0.16||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.16|-0.67|0.2324
71748229|NCT03192176|143005292|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0736|TWO_SIDED|95.0|-0.8|0.04||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.04|-0.80|0.0736
71677013|NCT03702010|142872426|SUPERIORITY|||||||0.624|||||||t-test, 2 sided|||End of Follow-up||||0.624
71748230|NCT03192176|143005292|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.008|TWO_SIDED|95.0|-0.98|-0.15||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.15|-0.98|0.0080
71748231|NCT03192176|143005292|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0028|TWO_SIDED|95.0|-1.07|-0.22||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.22|-1.07|0.0028
71780414|NCT04547712|143060402|SUPERIORITY|||||||0.0491||||||Nominal p-value is provided.|t-test, 2 sided|||Null Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \>= 0; Alternative Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED \< 0||||0.0491
71780415|NCT00594659|143060404|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||accelerated bootstrapping|||Pairwise comparison; non-parametric tests performed because of non-normal distribution||||<0.05
71748232|NCT03192176|143005292|SUPERIORITY||LSMean differnce|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4647|TWO_SIDED|95.0|-0.58|0.26||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.26|-0.58|0.4647
71748233|NCT03192176|143005292|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.92|-0.1||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||-0.10|-0.92|0.0160
71748234|NCT03192176|143005292|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0901|TWO_SIDED|95.0|-0.78|0.06||LS Means, SE, CI, and p-values come from an ANCOVA model with change from baseline as the dependent variable and treatment group, pooled center, smoking status as factors and baseline measurement, baseline weight as covariates.|ANCOVA|||||0.06|-0.78|0.0901
71748235|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0865|TWO_SIDED|95.0|-2.92|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||0.20|-2.92|0.0865
71748236|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0009|TWO_SIDED|95.0|-4.22|-1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.10|-4.22|0.0009
71780416|NCT00594659|143060404|SUPERIORITY_OR_OTHER||||||<|0.05|||||||accelerated bootstrapping|||pairwise comparison; non-parametric analysis||||< .05
71780417|NCT00594659|143060404|SUPERIORITY_OR_OTHER||||||>|0.05|||||||accelerated bootstrapping|||nonparametric pairwise comparison; non-normal distribution||||> 0.05
71780418|NCT00594659|143060405|SUPERIORITY_OR_OTHER||Slope|3.11|STANDARD_ERROR_OF_MEAN|0.69|<|0.05|TWO_SIDED||||||piecewise mixed model with logit link an|Performed across all assessments.|Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p \< 0.05. All other pairwise comparisons p \> 0.05.|pairwise comparisons among groups across 4 follow-up timepoints||||< 0.05
71666651|NCT00486525|142848004|SUPERIORITY_OR_OTHER||Slope|-0.056|STANDARD_ERROR_OF_MEAN|0.022||0.01|TWO_SIDED|95.0|-0.098|-0.013|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.013|-0.098|0.01
71748237|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|1e-05|TWO_SIDED|95.0|-5.06|-1.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.94|-5.06|<0.00001
71748238|NCT03192176|143005293|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|1e-05|TWO_SIDED|95.0|-5.63|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.47|-5.63|<0.00001
71748239|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.236|TWO_SIDED|95.0|-2.55|0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.63|-2.55|0.2360
71748240|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|-2.4||0.0032|TWO_SIDED|95.0|-3.92|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.80|-3.92|0.0032
71748241|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0006|TWO_SIDED|95.0|-4.29|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.19|-4.29|0.0006
71748242|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1318|TWO_SIDED|95.0|-2.86|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.38|-2.86|0.1318
71748243|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.83||0.0014|TWO_SIDED|95.0|-4.3|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.04|-4.30|0.0014
71748244|NCT03192176|143005293|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED|95.0|-4.82|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.58|-4.82|0.0001
71677014|NCT03702010|142872427|SUPERIORITY|||||||0.589|||||||t-test, 2 sided|||After first stimulation||||0.589
71677015|NCT03702010|142872427|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||After second stimulation||||0.704
71677016|NCT03702010|142872427|SUPERIORITY|||||||0.908|||||||t-test, 2 sided|||End of Follow-up||||0.908
71748245|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.84|<|0.0001|TWO_SIDED|95.0|-5.3|-2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.00|-5.30|<0.0001
71748246|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.84||0.0752|TWO_SIDED|95.0|-3.15|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.15|-3.15|0.0752
71748247|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0343|TWO_SIDED|95.0|-3.38|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-3.38|0.0343
71748248|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.82||0.0049|TWO_SIDED|95.0|-3.95|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.71|-3.95|0.0049
71748249|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.84||0.0285|TWO_SIDED|95.0|-3.5|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.20|-3.50|0.0285
71748250|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.85||0.0004|TWO_SIDED|95.0|-4.69|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.37|-4.69|0.0004
71748251|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.14|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-5.14|<0.0001
71891418|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.090|0.039|<0.0001
71891419|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.013||0.0118|TWO_SIDED|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.058|0.007|0.0118
71891420|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.013||0.2416|TWO_SIDED|95.0|-0.01|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.040|-0.010|0.2416
71780419|NCT01945281|143060489|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-24.3|27.7|||||Caspofungin minus Amphotericin|||27.7|-24.3|
71780420|NCT01945281|143060490|OTHER|Miettinen \& Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel's weights.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-30.2|22.6|||||Caspofungin minus Amphotericin|||22.6|-30.2|
71780421|NCT00885846|143060536|NON_INFERIORITY_OR_EQUIVALENCE|Regression analysis performed for equal variance at baseline.||||||0.664||95.0|||||Repeated ANOVA|degrees of freedom = 2||Power analysis suggested 27 participants, 9 in each group.||||0.664
71780422|NCT03719612|143060537|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|4.947||0.358|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.358
71780423|NCT03719612|143060537|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|5.699||0.804|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.804
71780424|NCT03719612|143060537|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|4.412||0.371|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.371
71780425|NCT03719612|143060538|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-1.28|STANDARD_DEVIATION|3.952||0.03|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.030
71780426|NCT03719612|143060538|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|4.466||0.312|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.312
71780427|NCT03719612|143060538|SUPERIORITY|Difference between Echo Enhanced and Echo Unenhanced|Mean Difference (Final Values)|-0.65|STANDARD_DEVIATION|4.725||0.347|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.347
71891421|NCT01431287|143304556|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.013||0.1792|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.043|-0.008|0.1792
71677017|NCT03702010|142872428|SUPERIORITY|||||||0.231|||||||t-test, 2 sided|||Baseline||||0.231
71677018|NCT03702010|142872428|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||After first stimulation||||0.663
71780428|NCT03719612|143060539|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability Echo Enhanced||0.988|0.977|
71780429|NCT03719612|143060539|OTHER||Intra-class Correlation Coefficient|0.953|||||TWO_SIDED|95.0|0.936|0.966||||||Inter-Reader Variability Echo Unenhanced||0.966|0.936|
71780430|NCT03719612|143060539|OTHER||Intra-class Correlation Coefficient|0.97|||||TWO_SIDED|95.0|0.958|0.978||||||Inter-Reader Variability Echo Enhanced||0.978|0.958|
71780431|NCT03719612|143060539|OTHER||Intra-class Correlation Coefficient|0.944|||||TWO_SIDED|95.0|0.923|0.959||||||Inter-Reader Variability Echo Unenhanced||0.959|0.923|
71780432|NCT03719612|143060539|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.947|0.972||||||Inter-Reader Variability Echo Enhanced||0.972|0.947|
71780433|NCT03719612|143060539|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability Echo Unenhanced||0.958|0.920|
71780434|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.988||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.988|0.978|
71780435|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.967|0.983||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.983|0.967|
71780436|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.963|0.981||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.981|0.963|
71780437|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.935|||||TWO_SIDED|95.0|0.91|0.952||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.952|0.910|
71780438|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.973|||||TWO_SIDED|95.0|0.962|0.98||||||Inter-Reader Variability End Diastolic Echo Enhanced||0.980|0.962|
71780439|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.924|||||TWO_SIDED|95.0|0.896|0.945||||||Inter-Reader Variability End Diastolic Echo Unenhanced||0.945|0.896|
71780440|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.989|||||TWO_SIDED|95.0|0.984|0.992||||||Inter-Reader Variability End Systolic Echo Enhanced||0.992|0.984|
71780441|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.983|||||TWO_SIDED|95.0|0.977|0.988||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.988|0.977|
71835102|NCT01631214|143174823|SUPERIORITY||Absolute risk reduction|1.84|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|0.51|3.17||||||"The absolute risk reduction (difference in percentages, Alendronate - Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, \> -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."||3.17|0.51|
71748252|NCT03192176|143005293|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-5.65|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRm|||Week 3||-2.28|-5.65|<0.0001
71748253|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.86||0.0169|TWO_SIDED|95.0|-3.74|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.37|-3.74|0.0169
71748254|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.84||0.0049|TWO_SIDED|95.0|-4.04|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.73|-4.04|0.0049
71748255|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.48|-1.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.18|-4.48|0.0008
71748256|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.84||0.0428|TWO_SIDED|95.0|-3.36|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-3.36|0.0428
71748257|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0004|TWO_SIDED|95.0|-4.65|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.34|-4.65|0.0004
71748258|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|-0.84||1e-05|TWO_SIDED|95.0|-4.88|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.58|-4.88|0.00001
71780442|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.978|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced||0.989|0.978|
71780443|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.948|||||TWO_SIDED|95.0|0.928|0.962||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.962|0.928|
71780444|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.978|||||TWO_SIDED|95.0|0.969|0.984||||||Inter-Reader Variability End Systolic Echo Enhanced||0.984|0.969|
71780445|NCT03719612|143060540|OTHER||Intra-class Correlation Coefficient|0.942|||||TWO_SIDED|95.0|0.92|0.958||||||Inter-Reader Variability End Systolic Echo Unenhanced||0.958|0.920|
71780446|NCT03719612|143060541|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.986|0.956|
71780447|NCT03719612|143060541|OTHER||Intra-class Correlation Coefficient|0.936|||||TWO_SIDED|95.0|0.888|0.963||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.963|0.888|
71780448|NCT03719612|143060541|OTHER||Intra-class Correlation Coefficient|0.961|||||TWO_SIDED|95.0|0.931|0.978||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.978|0.931|
71780449|NCT03719612|143060541|OTHER||Intra-class Correlation Coefficient|0.921|||||TWO_SIDED|95.0|0.864|0.955||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.955|0.864|
71780450|NCT03719612|143060541|OTHER||Intra-class Correlation Coefficient|0.947|||||TWO_SIDED|95.0|0.907|0.97||||||Inter-Reader Variability Echo Enhanced Sub-Optimal Echocardiograms||0.970|0.907|
71780451|NCT03719612|143060541|OTHER||Intra-class Correlation Coefficient|0.903|||||TWO_SIDED|95.0|0.834|0.945||||||Inter-Reader Variability Echo Unenhanced Sub-Optimal Echocardiograms||0.945|0.834|
71780452|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.984|||||TWO_SIDED|95.0|0.971|0.991||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.971|
71780453|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.975|||||TWO_SIDED|95.0|0.956|0.986||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.956|
71780454|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
71780455|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.94|||||TWO_SIDED|95.0|0.896|0.966||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.966|0.896|
71780456|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.977|||||TWO_SIDED|95.0|0.959|0.987||||||Inter-Reader Variability End Diastolic Echo Enhanced Sub-Optimal Echocardiograms||0.987|0.959|
71780457|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.923|||||TWO_SIDED|95.0|0.866|0.956||||||Inter-Reader Variability End Diastolic Echo Unenhanced Sub-Optimal Echocardiograms||0.956|0.866|
71780458|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.982|0.994||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.994|0.982|
71780459|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.976|||||TWO_SIDED|95.0|0.957|0.986||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.986|0.957|
71780460|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.985|||||TWO_SIDED|95.0|0.973|0.991||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.991|0.973|
71748259|NCT03192176|143005293|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|95.0|-5.73|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.37|-5.73|<0.0001
71891422|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.074|<0.0001
71748260|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0225|TWO_SIDED|95.0|-3.64|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.28|-3.64|0.0225
71891423|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.033|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.084|0.033|<0.0001
71677019|NCT03702010|142872428|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||After second stimulation||||0.998
71748261|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.84||0.0008|TWO_SIDED|95.0|-4.49|-1.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.19|-4.49|0.0008
71748262|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.42|-4.70|0.0003
71748263|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1168|TWO_SIDED|95.0|-2.8|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.31|-2.80|0.1168
71748264|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0012|TWO_SIDED|95.0|-4.15|-1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.03|-4.15|0.0012
71748265|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.54|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.42|-4.54|0.0002
71748266|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.44|-2.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.28|-5.44|<0.0001
71748267|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.8||0.0134|TWO_SIDED|95.0|-3.58|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.42|-3.58|0.0134
71748268|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.76|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-3.76|0.0057
71748269|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0016|TWO_SIDED|95.0|-4.06|-0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.96|-4.06|0.0016
71748270|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.79||0.0843|TWO_SIDED|95.0|-2.94|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.19|-2.94|0.0843
71748271|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.9|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.77|-3.90|0.0035
71748272|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.52|-4.66|0.0001
71780461|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.929|||||TWO_SIDED|95.0|0.876|0.959||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.959|0.876|
71891424|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.057|0.107||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.107|0.057|<0.0001
71891425|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0002|TWO_SIDED|95.0|0.023|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.073|0.023|0.0002
71891426|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0014|TWO_SIDED|95.0|0.016|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.067|0.016|0.0014
71891427|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1747|TWO_SIDED|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.043|-0.008|0.1747
71891428|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.04|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.040|<0.0001
71891429|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.013||0.0016|TWO_SIDED|95.0|0.016|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.066|0.016|0.0016
71748273|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.28|-2.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.10|-5.28|<0.0001
71780462|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.981|||||TWO_SIDED|95.0|0.966|0.989||||||Inter-Reader Variability End Systolic Echo Enhanced Sub-Optimal Echocardiograms||0.989|0.966|
71780463|NCT03719612|143060542|OTHER||Intra-class Correlation Coefficient|0.916|||||TWO_SIDED|95.0|0.855|0.952||||||Inter-Reader Variability End Systolic Echo Unenhanced Sub-Optimal Echocardiograms||0.952|0.855|
71780464|NCT02983825|143060587|SUPERIORITY|Wilcoxon signed-rank test for nonparametric matched-pairs||||||0.02|||||||Sign test|||"Within subject repeat analysis; V/Q mismatch (measured as degree of right shift in kPa) baseline vs best CPAP"||||0.02
71780465|NCT02284516|143060605|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.16|STANDARD_ERROR_OF_MEAN|2.096|=|0.0007|TWO_SIDED|95.0|3.04|11.28||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||||11.28|3.04|=0.0007
71677020|NCT03702010|142872428|SUPERIORITY|||||||0.713|||||||t-test, 2 sided|||End of Follow-up||||0.713
71677021|NCT01080118|142872430|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.05||||0.001|TWO_SIDED|99.0|0.05|0.05|||t-test, 2 sided|||||.05|.05|.001
71748274|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0315|TWO_SIDED|95.0|-3.33|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.16|-3.33|0.0315
71780466|NCT02284516|143060606|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|7.85|STANDARD_ERROR_OF_MEAN|1.792|<|0.0001|TWO_SIDED|95.0|4.33|11.37||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 14||11.37|4.33|<0.0001
71780467|NCT02284516|143060606|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|9.32|STANDARD_ERROR_OF_MEAN|1.976|<|0.0001|TWO_SIDED|95.0|5.44|13.2||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance \[ANOVA\]).|ANOVA|||Baseline and Day 42||13.20|5.44|<0.0001
71780468|NCT01323959|143060654|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|96.8|||||TWO_SIDED|95.0|89.0|99.6|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|"The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing."||99.6|89|
71813059|NCT05674890|143128457|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-2.11|STANDARD_DEVIATION|2.81|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
71677022|NCT01080118|142872430|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.001||95.0|||||t-test, 2 sided|||||||.001
71780469|NCT01323959|143060654|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|95.7|||||TWO_SIDED|95.0|87.8|99.1|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||99.1|87.8|
71780470|NCT01323959|143060654|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|100.0|||||TWO_SIDED|95.0|94.8|100.0|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||100|94.8|
71780471|NCT01323959|143060656|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|92.1|||||TWO_SIDED|95.0|82.4|97.4|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.||97.4|82.4|
71780472|NCT01323959|143060656|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|79.4|||||TWO_SIDED|95.0|67.9|88.3|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||88.3|67.9|
71780473|NCT01323959|143060656|SUPERIORITY_OR_OTHER||Percentage of subjects seroprotected|84.1|||||TWO_SIDED|95.0|73.3|91.8|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result \<0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.||91.8|73.3|
71780474|NCT02993757|143060671|OTHER||GMT ratio|0.982|||||TWO_SIDED|95.0|0.664|1.45||||||Antigen HPV-6||1.45|0.664|
71780475|NCT02993757|143060671|OTHER||GMT ratio|0.804|||||TWO_SIDED|95.0|0.626|1.03||||||Antigen HPV-11||1.03|0.626|
71780476|NCT02993757|143060671|OTHER||GMT ratio|0.815|||||TWO_SIDED|95.0|0.608|1.09||||||Antigen HPV-16||1.09|0.608|
71780477|NCT02993757|143060671|OTHER||GMT ratio|0.795|||||TWO_SIDED|95.0|0.603|1.05||||||Antigen HPV-18||1.05|0.603|
71780478|NCT02993757|143060672|OTHER||GMT ratio|0.987|||||TWO_SIDED|95.0|0.574|1.7||||||Serotype 1||1.70|0.574|
71780479|NCT02993757|143060672|OTHER||GMT ratio|0.783|||||TWO_SIDED|95.0|0.5|1.22||||||Serotype 2||1.22|0.500|
71780480|NCT02993757|143060672|OTHER||GMT ratio|0.836|||||TWO_SIDED|95.0|0.568|1.23||||||Serotype 3||1.23|0.568|
71780481|NCT02993757|143060672|OTHER||GMT ratio|1.07|||||TWO_SIDED|95.0|0.813|1.4||||||Serotype 4||1.40|0.813|
71780482|NCT02762578|143060686|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Non-inferiority with respect to change from baseline in HbA1c (%) to week 26 for IDegAsp vs. BIAsp 30.~Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
71780483|NCT02762578|143060686|SUPERIORITY|"If non-inferiority was confirmed, the superiority of the IDegAsp group over the BIAsp 30 group was to be investigated.~Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval, which was calculated using the FAS, was below 0%."|Treatment contrast|-0.08||||0.243|TWO_SIDED|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.||0.05|-0.20|0.2430
71780484|NCT02762578|143060687|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Superiority with respect to change from baseline in FPG to week 26 for IDegAsp vs. BIAsp 30 (Provided that non-inferiority was confirmed for the primary endpoint)~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero."|Treatment Contrast|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.||-1.10|-1.74|<0.0001
71780485|NCT02762578|143060688|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: Superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in FPG to week 26 was confirmed for IDegAsp vs. BIAsp 30).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.53||||0.0112|TWO_SIDED|95.0|0.33|0.87|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.||0.87|0.33|0.0112
71780486|NCT02762578|143060689|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.57||||0.0002|TWO_SIDED|95.0|0.42|0.77|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate||0.77|0.42|0.0002
71780487|NCT02762578|143060690|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: Superiority with respect to change from baseline in body weight for IDegAsp vs. BIAsp 30 (provided that Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group-BIAsp 30 group) was entirely below zero"|Treatment contrast|0.61||||0.0092|TWO_SIDED|95.0|0.15|1.08|||ANCOVA|Two-sided p-value for testing difference||The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.||1.08|0.15|0.0092
71780488|NCT02762578|143060691|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 6: Superiority with respect to subjects achieving HbA1c \< 7% at end of trial without confirmed hypoglycaemia for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in body weight was confirmed).~Superiority was considered confirmed if the 95% CI for the odds ratio (IDegAsp group/BIAsp 30 group) was entirely above one."|Treatment Ratio|2.22||||0.0002|TWO_SIDED|95.0|1.47|3.35||Two-sided p-value for testing difference|Regression, Logistic|||The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.||3.35|1.47|0.0002
71780489|NCT01090492|143060764|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.11||||0.6513|TWO_SIDED|80.0|-0.21|0.44|||ANCOVA|||PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.44|-0.21|0.6513
71780490|NCT01090492|143060764|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.69||||0.0057|TWO_SIDED|80.0|-0.99|-0.38|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.38|-0.99|0.0057
71780491|NCT01090492|143060764|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.1157|TWO_SIDED|80.0|-0.8|-0.08|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.08|-0.80|0.1157
71780492|NCT01090492|143060764|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6286|TWO_SIDED|80.0|-0.56|0.25|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.25|-0.56|0.6286
71780493|NCT01090492|143060765|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12||||0.9504|TWO_SIDED|80.0|-2.43|2.68|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||2.68|-2.43|0.9504
71780494|NCT01090492|143060765|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35||||0.4651|TWO_SIDED|80.0|-3.74|1.03|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.03|-3.74|0.4651
71780495|NCT01090492|143060765|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.59||||0.7423|TWO_SIDED|80.0|-2.92|1.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.73|-2.92|0.7423
71780496|NCT01090492|143060765|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.91||||0.3524|TWO_SIDED|80.0|-4.55|0.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.73|-4.55|0.3524
71780497|NCT01090492|143060766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.21||||0.79|TWO_SIDED|80.0|-4.61|7.03|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||7.03|-4.61|0.7900
71835103|NCT01631214|143174824|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.71|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|0.57|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||0.88|0.57|0.002
71835104|NCT01631214|143174825|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|STANDARD_ERROR_OF_MEAN|0.16||0.057|TWO_SIDED|95.0|0.54|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.54|0.057
71666652|NCT00486525|142848005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.33|TWO_SIDED|95.0|-0.31|0.11|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.11|-0.31|0.33
71666653|NCT00486525|142848005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.014|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-0.014|-0.44|0.037
71780498|NCT01090492|143060766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.17||||0.1463|TWO_SIDED|80.0|-11.61|-0.73|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.73|-11.61|0.1463
71780499|NCT01090492|143060766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.37||||0.1446|TWO_SIDED|80.0|-4.44|-0.29|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.29|-4.44|0.1446
71666654|NCT00486525|142848005|SUPERIORITY_OR_OTHER||Slope|-0.034|STANDARD_ERROR_OF_MEAN|0.0235||0.33|TWO_SIDED|95.0|-0.1|0.035|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.035|-0.10|0.33
71666655|NCT00486525|142848005|SUPERIORITY_OR_OTHER||Slope|-0.078|STANDARD_ERROR_OF_MEAN|0.036||0.03|TWO_SIDED|95.0|-0.15|-0.0074|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.0074|-0.15|0.03
71780500|NCT01090492|143060766|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.09||||0.5497|TWO_SIDED|80.0|-3.45|1.26|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||1.26|-3.45|0.5497
71780501|NCT01090492|143060767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.15||||0.5909|TWO_SIDED|80.0|-0.21|0.52|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.52|-0.21|0.5909
71780502|NCT01090492|143060767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.77||||0.0053|TWO_SIDED|80.0|-1.12|-0.43|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.43|-1.12|0.0053
71780503|NCT01090492|143060767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.3462|TWO_SIDED|80.0|-0.67|0.1|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||0.10|-0.67|0.3462
71780504|NCT01090492|143060767|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44||||0.194|TWO_SIDED|80.0|-0.88|-0.01|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.||-0.01|-0.88|0.1940
71677023|NCT02004886|142872432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.9|||<|0.001|TWO_SIDED|95.0|-38.4|-13.3|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.3|-38.4|<0.001
71780505|NCT01611155|143060778|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71780506|NCT01611155|143060779|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||Motor subscale||||0.53
71780507|NCT01611155|143060779|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||autonomic subscale||||0.89
71780508|NCT03344796|143060802|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71780509|NCT03344796|143060803|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71780510|NCT03344796|143060804|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71780511|NCT03344796|143060805|SUPERIORITY||||||<|0.1|||||||Chi-squared|||Knowledge of sun protection score at baseline compared with score after completion of the arm. The hypothesis is that the focus group, usability test and structured interviews arms will not have significant change in knowledge. It is expected that cohort studies 1 and 2 will have significant change in knowledge of sun protection.||||< 0.1
71780512|NCT00453063|143060818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.001
71780513|NCT00453063|143060819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304||95.0|||||ANCOVA|||||||0.304
71780514|NCT00453063|143060820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
71780515|NCT00453063|143060821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||ANCOVA|||||||0.063
71780516|NCT00453063|143060822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356||95.0|||||ANCOVA|||||||0.356
71780517|NCT03128411|143060837|SUPERIORITY||||||<|0.0001|||||||z-test, 1-sided|||With a sample size of 60 participants, study was powered at \>82% to test null hypothesis: true MMR rate at 12 months (48 weeks) is 25% versus alternative hypothesis: true MMR rate is 40% with one-sided alpha of 5%.||||<0.0001
71666656|NCT00486525|142848006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.2||0.058|TWO_SIDED|95.0|-8.5|0.15|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.15|-8.5|0.058
71780518|NCT04997304|143060972|OTHER|Test of paired differences||||||0.0019|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0019
71780519|NCT04997304|143060972|OTHER|Test of paired differences||||||0.002|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0020
71780520|NCT04997304|143060973|OTHER|Test of paired differences||||||0.0008|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.0008
71780521|NCT04997304|143060973|OTHER|Test of paired differences||||||0.0003|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0003
71780522|NCT04997304|143060974|OTHER|Test of paired differences||||||0.04|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for AirDuo||||0.04
71780523|NCT04997304|143060974|OTHER|Test of paired differences||||||0.0965|||||||t-test, 2 sided|Paired t-test||This analysis applies only to comparison of baseline and exacerbation for ProAir||||0.0965
71780524|NCT06934993|143060980|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
71780525|NCT06934993|143060981|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In all cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
71780526|NCT06934993|143060981|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
71677024|NCT02004886|142872432|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-53.6|||<|0.001|TWO_SIDED|95.0|-66.1|-41.1|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-41.1|-66.1|<0.001
71780527|NCT06934993|143060981|SUPERIORITY||||||<|0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||<0.001
71780528|NCT06934993|143060982|SUPERIORITY|||||||0.001||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.001
71780529|NCT06934993|143060982|SUPERIORITY|||||||0.096||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.096
71780530|NCT06934993|143060983|SUPERIORITY|||||||0.04||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.04
71677025|NCT02004886|142872432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-38.4|-13.6|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.||||-13.6|-38.4|<0.001
71780531|NCT06934993|143060983|SUPERIORITY|||||||0.679||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.679
71780532|NCT06934993|143060983|SUPERIORITY|||||||0.011||||||Statistical significance was defined as cases where the p-value was below 0.05.|Chi-squared|||In LIMA-LAD cases, when the post hoc power analysis results for the relationship between graft patency and flow rate were examined, the effect size was found to be 0.836, with an alpha error level set at 0.05. The statistical power of the study was determined to be 99.99%.||||0.011
71780533|NCT01594281|143060996|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.8||||0.0344|TWO_SIDED|95.0|-5.4|-0.2|||ANCOVA|||||-0.2|-5.4|0.0344
71780534|NCT01594281|143060996|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-1.2||||0.3809|TWO_SIDED|95.0|-3.8|1.5|||ANCOVA|||||1.5|-3.8|0.3809
71780535|NCT01594281|143060996|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|1.7||||0.2113|TWO_SIDED|95.0|-1.0|4.3|||ANCOVA|||||4.3|-1.0|0.2113
71780536|NCT01594281|143060997|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.4||||0.0081|TWO_SIDED|95.0|-4.2|-0.6|||ANCOVA|||||-0.6|-4.2|0.0081
71780537|NCT01594281|143060997|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-0.3||||0.7494|TWO_SIDED|95.0|-2.0|1.5|||ANCOVA|||||1.5|-2.0|0.7494
71780538|NCT01594281|143060997|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|2.1||||0.0175|TWO_SIDED|95.0|0.4|3.9|||ANCOVA|||||3.9|0.4|0.0175
71780539|NCT01594281|143060998|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|5.5||||0.0495|TWO_SIDED|95.0|0.0|11.0|||ANCOVA|||||11.0|0.0|0.0495
71780540|NCT01594281|143060998|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|3.0||||0.2767|TWO_SIDED|95.0|-2.5|8.5|||ANCOVA|||||8.5|-2.5|0.2767
71780541|NCT01594281|143060998|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.5||||0.3641|TWO_SIDED|95.0|-7.9|2.9|||ANCOVA|||||2.9|-7.9|0.3641
71780542|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.47||||0.4019|TWO_SIDED|95.0|0.08|2.749|||Regression, Logistic|||≥10 letters gain||2.749|0.080|0.4019
71780543|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.833||||0.2772|TWO_SIDED|95.0|0.614|5.471|||Regression, Logistic|||≥5 letters gain||5.471|0.614|0.2772
71780544|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.412||||0.4731|TWO_SIDED|95.0|0.55|3.622|||Regression, Logistic|||No clinically relevant change||3.622|0.55|0.4731
71780545|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.35||||0.065|TWO_SIDED|95.0|0.155|1.068|||Regression, Logistic|||≥5 letters loss||1.068|0.155|0.065
71780546|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.229|4.361|||Regression, Logistic|||≥10 letters loss||4.361|0.229|1.000
71780547|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.314||||0.3261|TWO_SIDED|95.0|0.031|3.173|||Regression, Logistic|||≥15 letters loss||3.173|0.031|0.3261
71677026|NCT02004886|142872435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.04|TWO_SIDED|95.0|-35.7|-0.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-0.9|-35.7|0.04
71780548|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.667||||0.668|TWO_SIDED|95.0|0.104|4.253|||Regression, Logistic|||≥10 letters gain||4.253|0.104|0.6680
71780549|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|2.842||||0.0838|TWO_SIDED|95.0|0.87|9.283|||Regression, Logistic|||≥5 letters gain||9.283|0.870|0.0838
71780550|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.674||||0.4116|TWO_SIDED|95.0|0.263|1.729|||Regression, Logistic|||No clinically relevant change||1.729|0.263|0.4116
71780551|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.621||||0.4197|TWO_SIDED|95.0|0.195|1.977|||Regression, Logistic|||≥5 letters loss||1.977|0.195|0.4197
71780552|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
71780553|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.029||||0.9839|TWO_SIDED|95.0|0.062|17.127|||Regression, Logistic|||≥15 letters loss||17.127|0.062|0.9839
71677027|NCT02004886|142872435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|||<|0.001|TWO_SIDED|95.0|-60.9|-26.3|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-26.3|-60.9|<0.001
71780554|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.663|TWO_SIDED|95.0|0.294|6.858|||Regression, Logistic|||≥10 letters gain||6.858|0.294|0.6630
71780555|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.55||||0.4941|TWO_SIDED|95.0|0.441|5.444||P-value was calculated as a point estimate.|Regression, Logistic|||≥5 letters gain||5.444|0.441|0.4941
71780556|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.477||||0.1259|TWO_SIDED|95.0|0.185|1.231|||Regression, Logistic|||No clinically relevant change||1.231|0.185|0.1259
71780557|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.773||||0.271|TWO_SIDED|95.0|0.64|4.913|||Regression, Logistic|||≥5 letters loss||4.913|0.640|0.2710
71780558|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|TWO_SIDED|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss||6.856|0.294|0.6632
71780559|NCT01594281|143060999|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|3.282||||0.314|TWO_SIDED|95.0|0.325|33.171|||Regression, Logistic|||≥15 letters loss||33.171|0.325|0.3140
71780560|NCT01594281|143061000|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.994||||0.9918|TWO_SIDED|95.0|0.327|3.026|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||3.026|0.327|0.9918
71780561|NCT01594281|143061000|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.607||||0.3595|TWO_SIDED|95.0|0.209|1.765|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.765|0.209|0.3595
71780562|NCT01594281|143061000|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.611||||0.3787|TWO_SIDED|95.0|0.204|1.83|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS||1.830|0.204|0.3787
71780563|NCT01594281|143061000|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.889||||0.9097|TWO_SIDED|95.0|0.116|6.806|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||6.806|0.116|0.9097
71780564|NCT01594281|143061000|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.341||||0.223|TWO_SIDED|95.0|0.06|1.925|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||1.925|0.060|0.2230
71780565|NCT01594281|143061000|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.383||||0.2792|TWO_SIDED|95.0|0.068|2.177|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS||2.177|0.068|0.2792
71780566|NCT01594281|143061001|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-40.7||||0.0003|TWO_SIDED|95.0|-62.1|-19.3|||ANCOVA|||||-19.3|-62.1|0.0003
71780567|NCT01594281|143061001|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-22.9||||0.0357|TWO_SIDED|95.0|-44.2|-1.6|||ANCOVA|||||-1.6|-44.2|0.0357
71780568|NCT01594281|143061001|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|17.8||||0.1034|TWO_SIDED|95.0|-3.7|39.3|||ANCOVA|||||39.3|-3.7|0.1034
71780569|NCT01594281|143061002|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-51.7||||0.0007|TWO_SIDED|95.0|-81.1|-22.3|||ANCOVA|||||-22.3|-81.1|0.0007
71780570|NCT01594281|143061002|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-28.9||||0.0542|TWO_SIDED|95.0|-58.4|0.5|||ANCOVA|||||0.5|-58.4|0.0542
71780571|NCT01594281|143061002|OTHER|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|22.8||||0.1288|TWO_SIDED|95.0|-6.7|52.3|||ANCOVA|||||52.3|-6.7|0.1288
71780572|NCT02195583|143061021|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.||Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.||||<0.0001
71780573|NCT02195583|143061021|SUPERIORITY_OR_OTHER|||||||0.2274||95.0|||||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.||Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.||||0.2274
71891430|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0081|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0081
71835105|NCT01631214|143174826|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|0.33|1.26|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.26|0.33|0.19
71677028|NCT02004886|142872435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.32|TWO_SIDED|95.0|-25.7|8.5|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||8.5|-25.7|0.320
71748275|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0063|TWO_SIDED|95.0|-3.75|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.75|0.0063
71748276|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0007|TWO_SIDED|95.0|-4.25|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.25|0.0007
71748277|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81||0.109|TWO_SIDED|95.0|-2.89|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.29|-2.89|0.1090
71748278|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0018|TWO_SIDED|95.0|-4.14|-0.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.95|-4.14|0.0018
71748279|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0004|TWO_SIDED|95.0|-4.54|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.34|-4.54|0.0004
71748280|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.4|-2.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.15|-5.40|<0.0001
71748281|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.82||0.0231|TWO_SIDED|95.0|-3.5|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-3.50|0.0231
71748282|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.81||0.0056|TWO_SIDED|95.0|-3.86|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.67|-3.86|0.0056
71677029|NCT02004886|142872437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.751|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||||0.9|-0.7|0.751
71677030|NCT02004886|142872437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.581|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||||0.6|-1.0|0.581
71748283|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.81||0.0007|TWO_SIDED|95.0|-4.35|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.17|-4.35|0.0007
71748284|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.3568|TWO_SIDED|95.0|-2.35|0.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.85|-2.35|0.3568
71748285|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0129|TWO_SIDED|95.0|-3.65|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-3.65|0.0129
71748286|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0018|TWO_SIDED|95.0|-4.19|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.97|-4.19|0.0018
71748287|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.83||0.0003|TWO_SIDED|95.0|-4.7|-1.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.42|-4.70|0.0003
71748288|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.83||0.1004|TWO_SIDED|95.0|-3.0|0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.27|-3.00|0.1004
71748289|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.82||0.0173|TWO_SIDED|95.0|-3.57|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.35|-3.57|0.0173
71666657|NCT00486525|142848006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|-11.4|-2.7|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||-2.7|-11.4|0.002
71780574|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.595|TWO_SIDED|95.0|-1.84|3.2|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||3.20|-1.84|0.5950
71780575|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.93||||0.0002|TWO_SIDED|95.0|2.38|7.48|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||7.48|2.38|0.0002
71677031|NCT02004886|142872437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.918|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||||0.8|-0.8|0.918
71748290|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.0038|TWO_SIDED|95.0|-3.97|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.77|-3.97|0.0038
71835106|NCT01631214|143174827|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.17||0.053|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.01|0.52|0.053
71677032|NCT02004886|142872439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.253|TWO_SIDED|95.0|-21.1|5.6|||ANCOVA|||||5.6|-21.1|0.253
71748291|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.1767|TWO_SIDED|95.0|-2.57|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.48|-2.57|0.1767
71748292|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.77||0.0308|TWO_SIDED|95.0|-3.2|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.16|-3.20|0.0308
71748293|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0013|TWO_SIDED|95.0|-4.07|-1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.00|-4.07|0.0013
71780576|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.25||||0.0013|TWO_SIDED|95.0|1.68|6.82|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||6.82|1.68|0.0013
71780577|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.71|||<|0.0001|TWO_SIDED|95.0|5.2|10.21|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).|||10.21|5.20|<0.0001
71780578|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.03|||<|0.0001|TWO_SIDED|95.0|4.51|9.55|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).|||9.55|4.51|<0.0001
71677033|NCT02004886|142872439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5||||0.07|TWO_SIDED|95.0|-26.0|1.0|||ANCOVA|||||1.0|-26.0|0.070
71748294|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.47|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.36|-4.47|0.0003
71748295|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.79||0.2109|TWO_SIDED|95.0|-2.55|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.56|-2.55|0.2109
71748296|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0152|TWO_SIDED|95.0|-3.44|-0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.37|-3.44|0.0152
71780579|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.0325|TWO_SIDED|95.0|0.23|5.32|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).|||5.32|0.23|0.0325
71666658|NCT00486525|142848006|SUPERIORITY_OR_OTHER||Slope|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.019|TWO_SIDED|95.0|-3.1|-0.28|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-0.28|-3.1|0.019
71748297|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.77||0.0075|TWO_SIDED|95.0|-3.61|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.56|-3.61|0.0075
71748298|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0869|TWO_SIDED|95.0|-2.96|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.20|-2.96|0.0869
71748299|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.052|TWO_SIDED|95.0|-3.14|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.01|-3.14|0.0520
71748300|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.81||0.0009|TWO_SIDED|95.0|-4.3|-1.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.12|-4.30|0.0009
71748301|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.82||0.0002|TWO_SIDED|95.0|-4.68|-1.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.46|-4.68|0.0002
71748302|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.82||0.0456|TWO_SIDED|95.0|-3.25|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-0.03|-3.25|0.0456
71748303|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.81||0.0073|TWO_SIDED|95.0|-3.76|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.59|-3.76|0.0073
71780580|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.092|TWO_SIDED|95.0|-4.67|0.35|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.|||0.35|-4.67|0.0920
71780581|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.2185|TWO_SIDED|95.0|-4.04|0.93|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.|||0.93|-4.04|0.2185
71835107|NCT01631214|143174828|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.56|STANDARD_ERROR_OF_MEAN|0.39||0.14|TWO_SIDED|95.0|0.26|1.22|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio \< 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."|||1.22|0.26|0.14
71845288|NCT05886777|143204401|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.673|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.300|0.673|
71748304|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0026|TWO_SIDED|95.0|-4.01|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.86|-4.01|0.0026
71748305|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.78||0.0878|TWO_SIDED|95.0|-2.87|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.20|-2.87|0.0878
71780582|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.87|||<|0.0001|TWO_SIDED|95.0|7.36|12.37|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).|||12.37|7.36|<0.0001
71780583|NCT02195583|143061021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.26|||<|0.0001|TWO_SIDED|95.0|6.77|11.75|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).|||11.75|6.77|<0.0001
71780584|NCT01709513|143061025|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.4|||<|0.0001|TWO_SIDED|95.0|-36.6|-24.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-24.2|-36.6|<0.0001
71780585|NCT01709513|143061026|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.1|||<|0.0001|TWO_SIDED|95.0|-40.7|-29.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-29.5|-40.7|<0.0001
71748306|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0182|TWO_SIDED|95.0|-3.39|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.32|-3.39|0.0182
71780586|NCT01709513|143061027|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.5|||<|0.0001|TWO_SIDED|95.0|-36.9|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-26.1|-36.9|<0.0001
71780587|NCT01709513|143061028|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.1|||<|0.0001|TWO_SIDED|95.0|-38.0|-28.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.2|-38.0|<0.0001
71780588|NCT01709513|143061029|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-29.8|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-29.8|<0.0001
71780589|NCT01709513|143061030|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.1|-24.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-24.4|-32.1|<0.0001
71780590|NCT01709513|143061031|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-30.4|-20.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.8|-30.4|<0.0001
71780591|NCT01709513|143061032|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-33.9|-25.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.8|-33.9|<0.0001
71748307|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.79||0.0002|TWO_SIDED|95.0|-4.55|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.44|-4.55|0.0002
71748308|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8||0.0002|TWO_SIDED|95.0|-4.53|-1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.40|-4.53|0.0002
71780592|NCT01709513|143061033|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.8|||<|0.0001|TWO_SIDED|95.0|-24.7|-17.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.0|-24.7|<0.0001
71780593|NCT01709513|143061034|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||<|0.0001|TWO_SIDED|95.0|-28.7|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-20.4|-28.7|<0.0001
71780594|NCT01709513|143061035|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-29.9|-21.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-21.5|-29.9|<0.0001
71780595|NCT01709513|143061036|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1|||<|0.0001|TWO_SIDED|95.0|-24.5|-17.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-17.7|-24.5|<0.0001
71780596|NCT01709513|143061037|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.5|||<|0.0001|TWO_SIDED|95.0|6.9|55.2||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||55.2|6.9|<0.0001
71780597|NCT01709513|143061038|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|24.9|||<|0.0001|TWO_SIDED|95.0|8.6|71.9||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||71.9|8.6|<0.0001
71748309|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.8||0.0387|TWO_SIDED|95.0|-3.22|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.09|-3.22|0.0387
71748310|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.79||0.0031|TWO_SIDED|95.0|-3.89|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.80|-3.89|0.0031
71666659|NCT00486525|142848006|SUPERIORITY_OR_OTHER||Slope|-2.8|STANDARD_ERROR_OF_MEAN|0.71||0.0001|TWO_SIDED|95.0|-4.2|-1.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||-1.4|-4.2|0.0001
71666660|NCT00486525|142848007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.4|11.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.4|1.4|0.01
71748311|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.0029|TWO_SIDED|95.0|-3.88|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.81|-3.88|0.0029
71748312|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.76||0.0653|TWO_SIDED|95.0|-2.9|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.09|-2.90|0.0653
71835108|NCT01631214|143174829|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|7.58|8.57|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an analysis of covariance (ANCOVA) model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||8.57|7.58|<0.001
71677034|NCT02004886|142872439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-39.5|-12.8|||ANCOVA|||||-12.8|-39.5|<0.001
71748313|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.76||0.0102|TWO_SIDED|95.0|-3.46|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.47|-3.46|0.0102
71748314|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.77||0.0002|TWO_SIDED|95.0|-4.38|-1.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.36|-4.38|0.0002
71748315|NCT03192176|143005293|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.72|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.67|-4.72|<0.0001
71748316|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0231|TWO_SIDED|95.0|-3.3|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.25|-3.30|0.0231
71677035|NCT02004886|142872440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-89.9||||0.002|TWO_SIDED|95.0|-145.6|-34.0|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-34.0|-145.6|0.002
71748317|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
71748318|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.76||0.0021|TWO_SIDED|95.0|-3.88|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.87|-3.88|0.0021
71748319|NCT03192176|143005293|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.76||0.0013|TWO_SIDED|95.0|-3.96|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.97|-3.96|0.0013
71748320|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84||0.146|TWO_SIDED|95.0|-2.89|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.43|-2.89|0.1460
71748321|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.84||0.6066|TWO_SIDED|95.0|-2.1|1.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.23|-2.10|0.6066
71891431|NCT01431287|143304557|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.611|TWO_SIDED|95.0|-0.019|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.032|-0.019|0.6110
71891432|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.085|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.059|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.111|0.059|<0.0001
71891433|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.025|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.076|0.025|0.0001
71891434|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.051|<0.0001
71891435|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.044|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.095|0.044|<0.0001
71891436|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.013||0.0013|TWO_SIDED|95.0|0.016|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|0.016|0.0013
71891437|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5274|TWO_SIDED|95.0|-0.017|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.034|-0.017|0.5274
71891438|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.052|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.103|0.052|<0.0001
71891439|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.013||0.0083|TWO_SIDED|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.060|0.009|0.0083
71891440|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.5744|TWO_SIDED|95.0|-0.018|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.018|0.5744
71891441|NCT01431287|143304558|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0381|TWO_SIDED|95.0|0.001|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.053|0.001|0.0381
71891442|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.055|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.108|0.055|<0.0001
71677036|NCT02004886|142872440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-191.1|||<|0.001|TWO_SIDED|95.0|-246.4|-135.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-135.9|-246.4|<0.001
71677037|NCT02004886|142872440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.7||||0.001|TWO_SIDED|95.0|-152.4|-42.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.||||-42.9|-152.4|0.001
71780598|NCT01709513|143061039|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|11.1|3022.1||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a last observation carried forward (LOCF) approach followed by Exact conditional logistic regression model.||3022.1|11.1|<0.0001
71780599|NCT01709513|143061040|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|109.8|||<|0.0001|TWO_SIDED|95.0|16.5|4759.3||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a LOCF approach followed by Exact conditional logistic regression model.||4759.3|16.5|<0.0001
71780600|NCT01709513|143061041|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-25.5|-11.8||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-11.8|-25.5|<0.0001
71780601|NCT01709513|143061042|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.9|||=|0.6997|TWO_SIDED|95.0|-3.8|5.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.6|-3.8|=0.6997
71780602|NCT01543958|143061051|SUPERIORITY_OR_OTHER|||||||0.87||||||not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.87
71780603|NCT01543958|143061052|SUPERIORITY_OR_OTHER|||||||0.62||||||Not adjusted for multiple comparisons|Sign test|no other adjustment||||||0.62
71780604|NCT02165215|143061114|SUPERIORITY||Adjusted difference in response rates|7.7||||0.1942|TWO_SIDED|95.0|-4.2|19.2|||Cochran-Mantel-Haenszel|||||19.2|-4.2|0.1942
71780605|NCT02165215|143061115|SUPERIORITY||Adjusted difference in remission rates|14.6||||0.1524|TWO_SIDED|95.0|-5.55|33.15||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.15|-5.55|0.1524
71780606|NCT02165215|143061116|SUPERIORITY||Adjusted difference in remission rates|8.7||||0.1466|TWO_SIDED|95.0|-3.26|20.21||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||20.21|-3.26|0.1466
71780607|NCT02165215|143061117|SUPERIORITY||Adjusted difference in remission rates|10.9||||0.3083||95.0|-9.72|30.49||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||30.49|-9.72|0.3083
71780608|NCT02165215|143061118|SUPERIORITY||Adjusted difference in response rates|14.4||||0.0235|TWO_SIDED|95.0|1.84|26.28||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||26.28|1.84|0.0235
71780609|NCT02165215|143061119|SUPERIORITY||Adjusted difference in remission rates|12.8||||0.0293||95.0|1.13|23.89||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.89|1.13|0.0293
71780610|NCT02165215|143061120|SUPERIORITY||Adjusted difference in remission rates|19.8||||0.0075|TWO_SIDED|95.0|5.16|33.11||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||33.11|5.16|0.0075
71780611|NCT02165215|143061121|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
71780612|NCT02165215|143061122|SUPERIORITY||Adjusted difference in remission rates|9.9||||0.1415||95.0|-4.47|23.13||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||23.13|-4.47|0.1415
71780613|NCT02165215|143061123|SUPERIORITY||Difference in Least Square Means|-2.8||||0.0266|TWO_SIDED|95.0|-5.3|-0.4||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.4|-5.3|0.0266
71780614|NCT02165215|143061124|SUPERIORITY||Difference in Least Square Means|-1.2||||0.0175|TWO_SIDED|95.0|-2.2|-0.2||p-value has not been adjusted for multiplicity|Cochran-Mantel-Haenszel|||||-0.2|-2.2|0.0175
71780615|NCT02165215|143061125|SUPERIORITY||Difference in Adjusted Mean|2.1||||0.6331|TWO_SIDED|95.0|-6.6|10.8||p-value has not been adjusted for multiplicity|ANCOVA|||||10.8|-6.6|0.6331
71780616|NCT01948947|143061139|OTHER||||||<|0.0001|||||||ANOVA|||Change from Baseline to 1-Week Post-Treatment||||<0.0001
71780617|NCT01948947|143061139|OTHER||||||<|0.001|||||||ANOVA|||Change from Baseline to 1-Month Post-Treatment||||<0.001
71780618|NCT01948947|143061140|OTHER||||||<|0.001||||||Change from Baseline to 1-Week post-treatment|ANOVA|||||||<0.001
71780619|NCT01948947|143061140|OTHER||||||<|0.01||||||Change from Baseline to 1-Month post-treatment|ANOVA|||||||<0.01
71780620|NCT01948947|143061141|OTHER|||||||0.009|||||||ANOVA|||||||0.009
71780621|NCT01948947|143061141|OTHER||||||<|0.01||||||Change in Baseline to 1-month post-treatment|ANOVA|||||||<0.01
71780622|NCT01948947|143061142|OTHER||||||=|0.033|||||||ANOVA|||||||=0.033
71780623|NCT05096221|143061143|SUPERIORITY||Least squares mean change difference|0.65|STANDARD_ERROR_OF_MEAN|0.55||0.2441|TWO_SIDED|95.0|-0.45|1.74|||Mixed model of repeated measures|||||1.74|-0.45|0.2441
71780624|NCT05096221|143061144|OTHER||||||<|0.0001|||||||Re-randomization test|||||||< 0.0001
71780625|NCT05096221|143061145|SUPERIORITY||Least squares mean change difference|-0.64|STANDARD_ERROR_OF_MEAN|0.21||0.0025|TWO_SIDED|95.0|-1.06|-0.23|||Mixed model of repeated measures|||||-0.23|-1.06|0.0025
71780626|NCT05096221|143061146|SUPERIORITY||Least squares mean change difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.0048|TWO_SIDED|95.0|-0.71|-0.13|||Mixed model of repeated measures|||||-0.13|-0.71|0.0048
71780627|NCT05096221|143061147|SUPERIORITY||Least squares mean change difference|-3.29|STANDARD_ERROR_OF_MEAN|2.52||0.1942|TWO_SIDED|95.0|-8.28|1.7|||Mixed model of repeated measures|||||1.70|-8.28|0.1942
71780628|NCT05096221|143061148|SUPERIORITY||Least squares mean change difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0412|TWO_SIDED|95.0|-0.71|-0.01|||Mixed model of repeated measures|||||-0.01|-0.71|0.0412
71780629|NCT05096221|143061149|SUPERIORITY||Least squares mean change difference|0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0402|TWO_SIDED|95.0|0.0|0.19|||Mixed model of repeated measures|||||0.19|0.00|0.0402
71780630|NCT05096221|143061150|SUPERIORITY||Least squares mean change difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4272|TWO_SIDED|95.0|-0.08|0.19|||Mixed model of repeated measures|||||0.19|-0.08|0.4272
71780631|NCT05096221|143061151|SUPERIORITY||Least squares mean change difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7324|TWO_SIDED|95.0|-0.24|0.17|||Mixed model of repeated measures|||||0.17|-0.24|0.7324
71780632|NCT05096221|143061152|SUPERIORITY||Least squares mean change difference|0.19|STANDARD_ERROR_OF_MEAN|0.44||0.6554|TWO_SIDED|95.0|-0.67|1.06|||Mixed model of repeated measures|||||1.06|-0.67|0.6554
71666661|NCT00486525|142848007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.5||0.01|TWO_SIDED|95.0|1.5|11.6|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||11.6|1.5|0.01
71666662|NCT00486525|142848007|SUPERIORITY_OR_OTHER||Slope|2.1|STANDARD_ERROR_OF_MEAN|0.85||0.016|TWO_SIDED|95.0|0.4|3.75|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||3.75|0.40|0.016
71666663|NCT00486525|142848007|SUPERIORITY_OR_OTHER||Slope|2.5|STANDARD_ERROR_OF_MEAN|0.85||0.0045|TWO_SIDED|95.0|0.77|4.14|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||4.14|0.77|0.0045
71748322|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.87||0.8422|TWO_SIDED|95.0|-1.88|1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.54|-1.88|0.8422
71748323|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.87||0.2346|TWO_SIDED|95.0|-2.74|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.67|-2.74|0.2346
71748324|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.87||0.1128|TWO_SIDED|95.0|-3.11|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.33|-3.11|0.1128
71748325|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1811|TWO_SIDED|95.0|-2.89|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.55|-2.89|0.1811
71748326|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3521|TWO_SIDED|95.0|-2.45|0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.87|-2.45|0.3521
71748327|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.357|TWO_SIDED|95.0|-2.44|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.44|0.3570
71780633|NCT04678661|143061155|SUPERIORITY|||||||0.207||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Regression, Linear|Model adjusted for covariates of age, race, baseline BMI, and baseline hemoglobin A1c.||||||.207
71780634|NCT04678661|143061156|OTHER|||||||0.011|||||||t-test, 2 sided|||Independent t-test||||.011
71677038|NCT02004886|142872441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.408|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||||3.7|-1.5|0.408
71748328|NCT03192176|143005293|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.84||0.9227|TWO_SIDED|95.0|-1.73|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.57|-1.73|0.9227
71748329|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8894|TWO_SIDED|95.0|-1.84|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.60|-1.84|0.8894
71748330|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.5074|TWO_SIDED|95.0|-2.29|1.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.13|-2.29|0.5074
71748331|NCT03192176|143005293|SUPERIORITY||LSMean differencce|-1.2|STANDARD_ERROR_OF_MEAN|0.87||0.1753|TWO_SIDED|95.0|-2.91|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.53|-2.91|0.1753
71748332|NCT03192176|143005293|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.88||0.1212|TWO_SIDED|95.0|-3.09|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.36|-3.09|0.1212
71780635|NCT04678661|143061157|OTHER|||||||0.024|||||||t-test, 2 sided|||||||.024
71780636|NCT04678661|143061158|OTHER|||||||0.579|||||||t-test, 2 sided|||||||.579
71780637|NCT04678661|143061159|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
71666664|NCT00486525|142848008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.28|TWO_SIDED|95.0|-3.0|0.88|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.88|-3.0|0.28
71666665|NCT00486525|142848008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.99||0.21|TWO_SIDED|95.0|-3.2|0.69|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.||0.69|-3.2|0.21
71666666|NCT00486525|142848008|SUPERIORITY_OR_OTHER||Slope|-0.66|STANDARD_ERROR_OF_MEAN|0.34||0.051|TWO_SIDED|95.0|-1.3|0.0039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.0039|-1.3|0.051
71666667|NCT00486525|142848008|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.098|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.||0.10|-1.2|0.098
71666668|NCT03573830|142848009|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.002|TWO_SIDED|95.0|0.04|0.2||Threshold for significance: \<0.05|t-test, 2 sided|||||0.20|0.04|0.002
71666669|NCT03573830|142848010|SUPERIORITY||Mean Difference (Final Values)|0.15||||0|TWO_SIDED|95.0|0.07|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.07|0.000
71666670|NCT03573830|142848011|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.352|TWO_SIDED|95.0|-0.03|0.07||Threshold for significance: 0.05|t-test, 2 sided|||||0.07|-0.03|0.352
71677039|NCT02004886|142872441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.741|TWO_SIDED|95.0|-3.1|2.2|||ANCOVA|||||2.2|-3.1|0.741
71748333|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.84||0.3702|TWO_SIDED|95.0|-2.41|0.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.90|-2.41|0.3702
71748334|NCT03192176|143005293|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.81||0.6459|TWO_SIDED|95.0|-1.22|1.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.96|-1.22|0.6459
71748335|NCT03192176|143005293|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.8248|TWO_SIDED|95.0|-1.4|1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.75|-1.40|0.8248
71748336|NCT03192176|143005293|SUPERIORITY||LSMean difference|0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4226|TWO_SIDED|95.0|-0.98|2.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.33|-0.98|0.4226
71748337|NCT03192176|143005293|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.6469|TWO_SIDED|95.0|-1.25|2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.01|-1.25|0.6469
71748338|NCT03192176|143005293|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.84||0.7642|TWO_SIDED|95.0|-1.41|1.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.91|-1.41|0.7642
71748339|NCT03192176|143005293|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.84||0.4068|TWO_SIDED|95.0|-2.36|0.966||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.966|-2.36|0.4068
71780638|NCT04678661|143061160|OTHER|||||||0.269|||||||t-test, 2 sided|||||||.269
71780639|NCT04678661|143061163|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
71780640|NCT04678661|143061164|OTHER||||||<|0.001||||||Reported p-value was calculated.|t-test, 2 sided|||||||<.001
71780641|NCT04678661|143061165|OTHER|||||||0.647|||||||t-test, 2 sided|||||||.647
71780642|NCT01397890|143061175|SUPERIORITY_OR_OTHER||Ratio|1.044||||0.0004|TWO_SIDED|95.0|1.019|1.069|||ANCOVA|multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate||||1.069|1.019|0.0004
71666671|NCT03573830|142848012|SUPERIORITY||Mean Difference (Final Values)|0.45||||0|TWO_SIDED|95.0|0.34|0.56||Threshold for significance: \<0.05|t-test, 2 sided|||||0.56|0.34|0.000
71780643|NCT01397890|143061176|SUPERIORITY_OR_OTHER||Ratio|1.079|||<|0.0001|TWO_SIDED|95.0|1.057|1.102|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.102|1.057|<0.0001
71780644|NCT01397890|143061177|SUPERIORITY_OR_OTHER||Ratio|1.086|||<|0.0001|TWO_SIDED|95.0|1.062|1.111|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.111|1.062|<0.0001
71666672|NCT03573830|142848013|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.002|TWO_SIDED|95.0|0.05|0.22||Threshold for significance: 0.05|t-test, 2 sided|||||0.22|0.05|0.002
71666673|NCT03573830|142848014|SUPERIORITY||Mean Difference (Final Values)|32.56||||0.033|TWO_SIDED|95.0|2.65|62.46||Threshold for significance: \<0.05|t-test, 2 sided|||||62.46|2.65|0.033
71666674|NCT03573830|142848016|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.065|TWO_SIDED|95.0|0.0|0.19||Threshold for significance: \<0.05|t-test, 2 sided|||||0.19|0.00|0.065
71666675|NCT03573830|142848017|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.03|TWO_SIDED|95.0|0.01|0.28||Threshold for significance: \<0.05|t-test, 2 sided|||||0.28|0.01|0.030
71666676|NCT01769456|142848019|OTHER||||||<|0.0001||||||Reported p-value is the calculated value provided by SAS output.|Wilcoxon Signed Rank Test|||||||< 0.0001
71666677|NCT01769456|142848020|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
71666678|NCT01769456|142848021|OTHER|||||||0.0003|||||||Wilcoxon Signed Rank Test|||||||0.0003
71666679|NCT01769456|142848022|OTHER|||||||0.0236|||||||Wilcoxon Signed Rank Test|||||||0.0236
71666680|NCT05490771|142848058|SUPERIORITY|||||||0.0341|||||||one-sided exact binomial test|||The ORR was compared against a null benchmark value of 5%. If the observed ORR were ≥5 of 31 (16%), it would then be concluded that the agent is promising and worthy of further investigation. When the number of analyzable cases (who were eligible and treated, and with outside assay results confirmed by the central MATCH assay) was \<31, the one-sided exact binomial test would be used for significance test with one-side type I error rate of 5%.||||0.0341
71666681|NCT02422797|142848061|NON_INFERIORITY|Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -10%.|Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-3.9|4.2|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI).|||4.2|-3.9|
71666682|NCT02422797|142848063|OTHER||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (\< or \>=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.|||1.8|-4.0|
71780645|NCT01397890|143061178|SUPERIORITY_OR_OTHER||Ratio|1.018||||0.057|TWO_SIDED|95.0|0.999|1.037|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.037|0.999|0.0570
71780646|NCT01397890|143061179|SUPERIORITY_OR_OTHER||Ratio|1.05|||<|0.0001|TWO_SIDED|95.0|1.033|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.067|1.033|<0.0001
71780647|NCT01397890|143061180|SUPERIORITY_OR_OTHER||Ratio|1.054|||<|0.0001|TWO_SIDED|95.0|1.036|1.073|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.073|1.036|<0.0001
71780648|NCT01397890|143061181|SUPERIORITY_OR_OTHER||Ratio|1.02||||0.1956|TWO_SIDED|95.0|0.99|1.05|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.050|0.990|0.1956
71780649|NCT01397890|143061182|SUPERIORITY_OR_OTHER||Ratio|1.062|||<|0.0001|TWO_SIDED|95.0|1.035|1.091|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.||||1.091|1.035|<0.0001
71780650|NCT01397890|143061183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.303||||0.0001|TWO_SIDED|95.0|9.904|30.702|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.702|9.904|0.0001
71780651|NCT01397890|143061184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.587|||<|0.0001|TWO_SIDED|95.0|7.407|19.766|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||19.766|7.407|<0.0001
71666683|NCT02422797|142848074|OTHER|||||||0.007||||||P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)|ANCOVA|||||||0.007
71666684|NCT02422797|142848074|SUPERIORITY||Odds Ratio (OR)|0.861||||0.011|TWO_SIDED|95.0|0.767|0.967||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.967|0.767|0.011
71666685|NCT02422797|142848074|SUPERIORITY||Odds Ratio (OR)|1.012||||0.745|TWO_SIDED|95.0|0.943|1.085||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||1.085|0.943|0.745
71666686|NCT02422797|142848074|SUPERIORITY||Odds Ratio (OR)|0.877||||0.018|TWO_SIDED|95.0|0.787|0.977||P value assessed the difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.977|0.787|0.018
71666687|NCT02422797|142848076|OTHER|||||||0.001||||||P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)|ANCOVA|||||||0.001
71677040|NCT02004886|142872441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.906|TWO_SIDED|95.0|-2.8|2.5|||ANCOVA|||||2.5|-2.8|0.906
71748340|NCT03192176|143005293|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.8||0.7974|TWO_SIDED|95.0|-1.37|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.37|0.7974
71780652|NCT01397890|143061185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.469|||<|0.0001|TWO_SIDED|95.0|10.147|24.791|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||24.791|10.147|<0.0001
71780653|NCT01397890|143061186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.428||||0.0001|TWO_SIDED|95.0|13.463|39.393|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||39.393|13.463|0.0001
71780654|NCT01397890|143061187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.192||||0.0006|TWO_SIDED|95.0|7.491|26.894|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.894|7.491|0.0006
71780655|NCT01397890|143061188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.472|||<|0.0001|TWO_SIDED|95.0|10.347|26.596|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||26.596|10.347|<0.0001
71780656|NCT01397890|143061189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.668|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.437|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.437|-0.900|<0.0001
71780657|NCT01397890|143061190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.375|||<|0.0001|TWO_SIDED|95.0|-0.552|-0.198|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.198|-0.552|<0.0001
71780658|NCT01397890|143061191|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||<|0.0001|TWO_SIDED|95.0|-0.741|-0.361|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.361|-0.741|<0.0001
71780659|NCT01397890|143061192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.236||||0.0028|TWO_SIDED|95.0|-0.391|-0.082|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.082|-0.391|0.0028
71780660|NCT01397890|143061193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.124||||0.0372|TWO_SIDED|95.0|-0.24|-0.007|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.007|-0.240|0.0372
71780661|NCT01397890|143061194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231||||0.0001|TWO_SIDED|95.0|-0.35|-0.113|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.113|-0.350|0.0001
71780662|NCT01397890|143061195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|||<|0.0001|TWO_SIDED|95.0|-0.364|-0.159|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.159|-0.364|<0.0001
71835109|NCT01631214|143174830|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.42|4.1|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.10|3.42|<0.001
71780663|NCT01397890|143061196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.143||||0.0067|TWO_SIDED|95.0|-0.246|-0.04|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.040|-0.246|0.0067
71780664|NCT01397890|143061197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.0171|TWO_SIDED|95.0|-0.222|-0.022|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||-0.022|-0.222|0.0171
71780665|NCT01397890|143061198|SUPERIORITY_OR_OTHER||Rate ratio|0.593||||0.0032|TWO_SIDED|95.0|0.419|0.839|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable morning PEF as a covariate||||0.839|0.419|0.0032
71780666|NCT01397890|143061198|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.614||||0.0167|TWO_SIDED|95.0|0.412|0.916|||Regression, Cox|Time to the first COPD exacerbation||||0.916|0.412|0.0167
71780667|NCT01397890|143061198|SUPERIORITY_OR_OTHER|||||||0.0196|||||||Log Rank|||||||0.0196
71780668|NCT02218320|143061214|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71780669|NCT02096731|143061221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.92|1.37|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.37|0.92|
71780670|NCT02096731|143061222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.1|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.10|0.69|
71780671|NCT02096731|143061223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.03|1.3|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.30|1.03|
71780672|NCT02096731|143061224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.36|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.36|0.81|
71677041|NCT02004886|142872442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.857|TWO_SIDED|95.0|-30.4|25.3|||ANCOVA|||||25.3|-30.4|0.857
71748341|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.78||0.0297|TWO_SIDED|95.0|-3.23|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.17|-3.23|0.0297
71748342|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|-4.66|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.58|-4.66|<0.0001
71780673|NCT02096731|143061225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|1.23|1.5|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."|||1.50|1.23|
71780674|NCT01496248|143061250|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780675|NCT01496248|143061251|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780676|NCT01496248|143061252|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780677|NCT01496248|143061253|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780678|NCT01496248|143061254|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780679|NCT01496248|143061255|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780680|NCT01496248|143061256|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780681|NCT01496248|143061257|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71780682|NCT01702805|143061259|SUPERIORITY||Risk Ratio (RR)|1.0||||0.93|TWO_SIDED|95.0|0.92|1.1|||Robust Poisson Regression|The relative risk was adjusted for birth-weight and center stratum.||Null hypothesis: A higher hemoglobin threshold for red-cell transfusions, as compared with a lower threshold, will not reduce nor increase the incidence of death or neurodevelopmental impairment in infants at 22 to 26 months of age corrected for prematurity.||1.10|0.92|0.93
71780683|NCT01350492|143061293|SUPERIORITY||Wilks' Lambda|0.939||||0.68|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.680
71780684|NCT01350492|143061294|SUPERIORITY||Wilks' Lambda|0.96||||0.854|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mulitvariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.854
71780685|NCT01350492|143061295|SUPERIORITY|||||||0.0002||||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.0002
71780686|NCT01350492|143061296|SUPERIORITY||Wilks' Lambda|0.857||||0.41|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.41
71780687|NCT01350492|143061297|SUPERIORITY||Wilks' Lambda|0.828||||0.16|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.16
71780688|NCT01350492|143061298|SUPERIORITY||Wilks' Lambda|0.919||||0.66|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Multivariate regression|A Generalized Linear Model was employed with repeated measurements of pain ratings as the multivariate dependent variables and group as covariate.||General multivariate regression models were used to estimate the time averaged difference in pain ratings and other symptom scores (continuous measurements) between the treatment and the control group. In order to achieve 90% power, at alpha equal to .05, with an effect size of .6 (minimum effect size of clinical importance) and with a correlation of .6 between measurements from each individual, we estimated the necessary sample size at 34 subjects per group.||||0.66
71780689|NCT04203498|143061299|SUPERIORITY||Difference in least squares means|-0.73|STANDARD_ERROR_OF_MEAN|0.914|=|0.4263|TWO_SIDED|95.0|-2.54|1.08|||Linear mixed model repeated measures|||Week 9 to 12 (primary outcome statistics)||1.08|-2.54|=0.4263
71677042|NCT02004886|142872442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.906|TWO_SIDED|95.0|-30.3|26.9|||ANCOVA|||||26.9|-30.3|0.906
71748343|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.78|<|1e-05|TWO_SIDED|95.0|-5.1|-2.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.02|-5.10|<0.00001
71780690|NCT00939640|143061314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||Wilcoxon matched-pairs|||||||.17
71780691|NCT00939640|143061315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon matched-pairs tests|||||||.02
71780692|NCT00939640|143061320|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
71780693|NCT00939640|143061321|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
71891443|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.053|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.027|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|0.027|<0.0001
71891444|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.039|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.091|0.039|<0.0001
71780694|NCT01768286|143061354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
71780695|NCT01768286|143061354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
71748344|NCT03192176|143005294|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.78|-2.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.66|-5.78|<0.0001
71748345|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.79||0.1318|TWO_SIDED|95.0|-2.76|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.36|-2.76|0.1318
71748346|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.001|TWO_SIDED|95.0|-4.13|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.05|-4.13|0.0010
71780696|NCT01768286|143061354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
71780697|NCT01768286|143061354|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test|||||||<0.001
71891445|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.029|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.081|0.029|<0.0001
71748347|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.78||0.0011|TWO_SIDED|95.0|-4.1|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.04|-4.10|0.0011
71748348|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.79||0.0405|TWO_SIDED|95.0|-3.2|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.07|-3.20|0.0405
71748349|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.7|-1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.55|-4.70|0.0001
71780698|NCT02168361|143061403|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Null hypothesis is no difference between two regimens in SVR-12.||||.02
71780699|NCT00758836|143061414|SUPERIORITY_OR_OTHER||Proportion difference|24.5|||<|0.001|TWO_SIDED|90.0|16.7|32.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.||||32.2|16.7|<0.001
71780700|NCT00758836|143061414|SUPERIORITY_OR_OTHER||Proportion difference|27.7|||<|0.001|TWO_SIDED|90.0|19.6|35.8|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||35.8|19.6|<0.001
71780701|NCT00758836|143061414|SUPERIORITY_OR_OTHER||Proportion difference|20.4|||<|0.001|TWO_SIDED|90.0|12.6|28.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||28.2|12.6|<0.001
71780702|NCT00758836|143061414|SUPERIORITY_OR_OTHER||Proportion differenece|4.2||||0.449|TWO_SIDED|90.0|-5.0|13.3|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||13.3|-5.0|0.449
71666688|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.728|||<|0.001|TWO_SIDED|95.0|0.686|0.773||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.773|0.686|<.001
71666689|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.865||||0.004|TWO_SIDED|95.0|0.785|0.954||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.954|0.785|0.004
71666690|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.788|||<|0.001|TWO_SIDED|95.0|0.719|0.864||P value assessed the difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.864|0.719|<.001
71666691|NCT02422797|142848076|OTHER|||||||0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA|||||||0.677
71666692|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.867|||<|0.001|TWO_SIDED|95.0|0.823|0.914||P value assessed the difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.914|0.823|<.001
71666693|NCT02422797|142848076|OTHER||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA|||||||<.001
71748350|NCT03192176|143005294|SUPERIORITY||LSMean differencce|-3.1|STANDARD_ERROR_OF_MEAN|0.8||0.0001|TWO_SIDED|95.0|-4.66|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.52|-4.66|0.0001
71748351|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.26|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.07|-5.26|<0.0001
71748352|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.81||0.0325|TWO_SIDED|95.0|-3.34|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.15|-3.34|0.0325
71780703|NCT00758836|143061414|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.182|TWO_SIDED|90.0|-1.8|17.1|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||17.1|-1.8|0.182
71666694|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.853|||<|0.001|TWO_SIDED|95.0|0.799|0.91||P value assessed the difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.910|0.799|<.001
71666695|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.886||||0.028|TWO_SIDED|95.0|0.796|0.987||P value assessed the difference between treatment groups (osteocalcin - INSTI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.987|0.796|0.028
71666696|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.743|||<|0.001|TWO_SIDED|95.0|0.672|0.822||P value assessed the difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.822|0.672|<.001
71666697|NCT02422797|142848076|OTHER|||||||0.782||||||P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA|||||||0.782
71666698|NCT02422797|142848076|SUPERIORITY||Odds Ratio (OR)|0.818|||<|0.001|TWO_SIDED|95.0|0.751|0.891||P value assessed the difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.|||0.891|0.751|<.001
71666699|NCT02422797|142848089|OTHER|||||||0.179||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value \<=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected|||||||0.179
71666700|NCT02422797|142848089|OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.6|8.6|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||8.6|-1.6|
71748353|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.8||0.0035|TWO_SIDED|95.0|-3.92|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.78|-3.92|0.0035
71748354|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0102|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.49|-3.61|0.0102
71748355|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.81||0.0098|TWO_SIDED|95.0|-3.69|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.51|-3.69|0.0098
71780704|NCT00758836|143061415|SUPERIORITY_OR_OTHER||Proportion difference|40.8|||<|0.001|TWO_SIDED|90.0|31.9|49.0|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||49.0|31.9|<0.001
71666701|NCT02422797|142848089|OTHER||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-12.1|7.4|||||INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||7.4|-12.1|
71780705|NCT00758836|143061415|SUPERIORITY_OR_OTHER||Proportion difference|39.9|||<|0.001|TWO_SIDED|90.0|30.5|48.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||48.5|30.5|<0.001
71780706|NCT00758836|143061415|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.265|TWO_SIDED|90.0|-2.9|14.9|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.9|-2.9|0.265
71780707|NCT00758836|143061415|SUPERIORITY_OR_OTHER||Proportion difference|5.2||||0.362|TWO_SIDED|90.0|-4.2|14.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||14.5|-4.2|0.362
71780708|NCT00758836|143061415|SUPERIORITY_OR_OTHER||Proportion difference|34.7|||<|0.001|TWO_SIDED|90.0|25.3|43.4|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.||||43.4|25.3|<0.001
71780709|NCT01817530|143061418|SUPERIORITY||Odds Ratio (OR)|32.51|||<|0.001|TWO_SIDED|95.0|11.12|95.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||95.05|11.12|< 0.001
71666702|NCT02422797|142848089|OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.9|3.1|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.|||3.1|-13.9|
71666703|NCT02422797|142848097|OTHER|||||||0.43||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA|||||||0.430
71780710|NCT01817530|143061418|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780711|NCT01817530|143061418|SUPERIORITY||Odds Ratio (OR)|16.66|||<|0.001|TWO_SIDED|95.0|6.72|41.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||41.3|6.72|< 0.001
71891446|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.013||0.0052|TWO_SIDED|95.0|0.011|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|0.011|0.0052
71891447|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.013||0.2273|TWO_SIDED|95.0|-0.01|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.010|0.2273
71666704|NCT02422797|142848097|OTHER||Mean Difference (Final Values)|-1.239||||0.039|TWO_SIDED|95.0|-2.414|-0.064||P value assessed the difference between treatment groups (Symptom Bother Score - Week 4)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||-0.064|-2.414|0.039
71666705|NCT02422797|142848097|OTHER|||||||0.542||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA|||||||0.542
71780712|NCT01817530|143061418|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780713|NCT01817530|143061418|SUPERIORITY||Odds Ratio (OR)|11.13|||<|0.001|TWO_SIDED|95.0|4.79|25.84||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||25.84|4.79|< 0.001
71780714|NCT01817530|143061418|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780715|NCT01817530|143061418|SUPERIORITY||Odds Ratio (OR)|19.62|||<|0.001|TWO_SIDED|95.0|7.81|49.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||49.27|7.81|< 0.001
71780716|NCT01817530|143061418|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780717|NCT01817530|143061418|SUPERIORITY||Odds Ratio (OR)|6.02|||<|0.001|TWO_SIDED|95.0|2.95|12.3||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||12.3|2.95|< 0.001
71780718|NCT01817530|143061418|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780719|NCT01817530|143061418|SUPERIORITY||Odds Ratio (OR)|10.34|||<|0.001|TWO_SIDED|95.0|4.79|22.34||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||22.34|4.79|< 0.001
71780720|NCT01817530|143061418|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780721|NCT01817530|143061419|SUPERIORITY||Odds Ratio (OR)|156.17|||<|0.001|TWO_SIDED|95.0|38.04|641.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||641.22|38.04|< 0.001
71780722|NCT01817530|143061419|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780723|NCT01817530|143061419|SUPERIORITY||Odds Ratio (OR)|66.07|||<|0.001|TWO_SIDED|95.0|21.1|206.88||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||206.88|21.1|< 0.001
71780724|NCT01817530|143061419|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780725|NCT01817530|143061419|SUPERIORITY||Odds Ratio (OR)|52.15|||<|0.001|TWO_SIDED|95.0|17.42|156.09||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||156.09|17.42|< 0.001
71780726|NCT01817530|143061419|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71666706|NCT02422797|142848097|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.448|TWO_SIDED|95.0|-1.896|0.84||P value assessed the difference between treatment groups (Symptom Bother Score - Week 24)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.840|-1.896|0.448
71666707|NCT02422797|142848097|OTHER|||||||0.402||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA|||||||0.402
71748356|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.18|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.98|-5.18|<0.0001
71780727|NCT01817530|143061419|SUPERIORITY||Odds Ratio (OR)|25.45|||<|0.001|TWO_SIDED|95.0|10.45|61.96||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||61.96|10.45|< 0.001
71748357|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.89|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.70|-4.89|<0.0001
71748358|NCT03192176|143005294|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.61|-2.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.37|-5.61|<0.0001
71780728|NCT01817530|143061419|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780729|NCT01817530|143061419|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.001|TWO_SIDED|95.0|4.38|21.25||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.25|4.38|< 0.001
71780730|NCT01817530|143061419|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71891448|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.045|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|0.045|<0.0001
71748359|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.82||0.0021|TWO_SIDED|95.0|-4.17|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.17|0.0021
71748360|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.81||0.0001|TWO_SIDED|95.0|-4.71|-1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.52|-4.71|0.0001
71780731|NCT01817530|143061419|SUPERIORITY||Odds Ratio (OR)|16.17|||<|0.001|TWO_SIDED|95.0|7.13|36.67||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||36.67|7.13|< 0.001
71780732|NCT01817530|143061419|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780733|NCT01817530|143061420|SUPERIORITY||Odds Ratio (OR)|123.14|||<|0.001|TWO_SIDED|95.0|25.93|584.85||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||584.85|25.93|< 0.001
71780734|NCT01817530|143061420|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780735|NCT01817530|143061420|SUPERIORITY||Odds Ratio (OR)|40.56|||<|0.001|TWO_SIDED|95.0|13.59|121.03||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||121.03|13.59|< 0.001
71780736|NCT01817530|143061420|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780737|NCT01817530|143061420|SUPERIORITY||Odds Ratio (OR)|19.01|||<|0.001|TWO_SIDED|95.0|7.44|48.58||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||48.58|7.44|< 0.001
71780738|NCT01817530|143061420|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780739|NCT01817530|143061420|SUPERIORITY||Odds Ratio (OR)|22.77|||<|0.001|TWO_SIDED|95.0|9.29|55.77||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||55.77|9.29|< 0.001
71780740|NCT01817530|143061420|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71748361|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.002|TWO_SIDED|95.0|-4.11|-0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.93|-4.11|0.0020
71748362|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.021|TWO_SIDED|95.0|-3.27|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.27|-3.27|0.0210
71748363|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.1|STANDARD_ERROR_OF_MEAN|0.77|<|0.0001|TWO_SIDED|95.0|-4.59|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-4.59|<0.0001
71748364|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.88|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.34|-1.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.33|-4.34|0.0003
71748365|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.29|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.23|-5.29|<0.0001
71748366|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.77||0.0023|TWO_SIDED|95.0|-3.91|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.86|-3.91|0.0023
71748367|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.76||0.0004|TWO_SIDED|95.0|-4.25|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.24|-4.25|0.0004
71748368|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0036|TWO_SIDED|95.0|-3.73|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.74|-3.73|0.0036
71748369|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.77||0.0195|TWO_SIDED|95.0|-3.33|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.29|-3.33|0.0195
71780741|NCT01817530|143061420|SUPERIORITY||Odds Ratio (OR)|10.89|||<|0.001|TWO_SIDED|95.0|4.88|24.27||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||24.27|4.88|< 0.001
71748370|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.21|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.17|-4.21|0.0006
71748371|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0004|TWO_SIDED|95.0|-4.32|-1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.27|-4.32|0.0004
71748372|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|-5.01|-1.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.92|-5.01|<0.0001
71748373|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0061|TWO_SIDED|95.0|-3.71|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.62|-3.71|0.0061
71748374|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0006|TWO_SIDED|95.0|-4.19|-1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.14|-4.19|0.0006
71748375|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.77||0.003|TWO_SIDED|95.0|-3.81|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.78|-3.81|0.0030
71780742|NCT01817530|143061420|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71677043|NCT02004886|142872442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.63|TWO_SIDED|95.0|-34.0|20.8|||ANCOVA|||||20.8|-34.0|0.630
71666708|NCT02422797|142848097|SUPERIORITY||Mean Difference (Final Values)|-1.037||||0.164|TWO_SIDED|95.0|-2.501|0.426||P value assessed the difference between treatment groups (Symptom Bother Score - Week 48)|ANCOVA||Estimates were calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.|||0.426|-2.501|0.164
71666709|NCT02422797|142848100|SUPERIORITY|||||||0.037||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.037
71666710|NCT02422797|142848100|SUPERIORITY|||||||0.101||||||P-value assessed the HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.101
71666711|NCT02422797|142848100|SUPERIORITY|||||||0.042||||||P-value assessed the HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.042
71666712|NCT02422797|142848100|SUPERIORITY|||||||0.132||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.132
71666713|NCT02422797|142848100|SUPERIORITY|||||||0.022||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.022
71666714|NCT02422797|142848100|SUPERIORITY|||||||0.004||||||P-value assessed the HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.004
71666715|NCT02422797|142848100|SUPERIORITY|||||||0.076||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test|||||||0.076
71666716|NCT02422797|142848100|SUPERIORITY|||||||0.073||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test|||||||0.073
71666717|NCT02422797|142848100|SUPERIORITY|||||||0.547||||||P-value assessed the HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test|||||||0.547
71666718|NCT03126435|142848115|SUPERIORITY|||||||0.6647|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.6647
71666719|NCT03126435|142848116|SUPERIORITY|||||||0.4345|||||||Log Rank|P-Value is from a stratified log-rank test.||||||0.4345
71666720|NCT03126435|142848117|SUPERIORITY|||||||0.2632|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records||||||0.2632
71666721|NCT03126435|142848119|SUPERIORITY|||||||0.1002|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.1002
71666722|NCT03126435|142848120|SUPERIORITY|||||||0.9882|||||||Regression, Logistic|P-value is from logistic regression model adjusted for stratification factors among non-missing records.||||||0.9882
71666723|NCT02276807|142848126|SUPERIORITY||Mean Difference (Final Values)|0.345|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline vs. Week 12) repeated measures ANOVA||||||<0.05
71748376|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0383|TWO_SIDED|95.0|-3.17|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.09|-3.17|0.0383
71748377|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.79||0.0004|TWO_SIDED|95.0|-4.33|-1.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.24|-4.33|0.0004
71748378|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.79||0.0011|TWO_SIDED|95.0|-4.14|-1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.04|-4.14|0.0011
71748379|NCT03192176|143005294|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-5.07|-1.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.93|-5.07|<0.0001
71780743|NCT01817530|143061420|SUPERIORITY||Odds Ratio (OR)|9.72|||<|0.001|TWO_SIDED|95.0|4.46|21.22||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.|Regression, Logistic|||||21.22|4.46|< 0.001
71780744|NCT01817530|143061420|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71666724|NCT02276807|142848127|SUPERIORITY||Mean Difference (Final Values)|0.046|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (time: Baseline vs. week 12) repeated measures ANOVA||||||<0.05
71780745|NCT01817530|143061421|SUPERIORITY||Odds Ratio (OR)|24.73|||<|0.001|TWO_SIDED|95.0|8.57|71.32||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||71.32|8.57|< 0.001
71780746|NCT01817530|143061421|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71666725|NCT02276807|142848128|SUPERIORITY||Mean Difference (Final Values)|0.666|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
71666726|NCT02276807|142848129|SUPERIORITY||Mean Difference (Final Values)|0.014|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA||||||<0.05
71666727|NCT02276807|142848130|SUPERIORITY||Mean Difference (Final Values)|0.722|||<|0.05|TWO_SIDED||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline vs. Week 12) Repeated Measures ANOVA||||||<0.05
71677044|NCT05239494|142872443|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.001|TWO_SIDED||||||Shapiro-Wilks|||This study used a ±50 VAS scale, with values in the positive and negative range indicating that the contact lenses were comfortable or uncomfortable, respectively. A score of zero on this scale indicated neutral CL comfort.||||<0.001
71677045|NCT02949843|142872491|OTHER|||||||0.6|||||||Fisher Exact|||Null Hypothesis is that each arm has equal rates of smoking history.||||0.6
71748380|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0055|TWO_SIDED|95.0|-3.8|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.66|-3.80|0.0055
71748381|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.79||0.0014|TWO_SIDED|95.0|-4.09|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-4.09|0.0014
71748382|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.78||0.004|TWO_SIDED|95.0|-3.8|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.73|-3.80|0.0040
71748383|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1502|TWO_SIDED|95.0|-2.68|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.41|-2.68|0.1502
71748384|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0057|TWO_SIDED|95.0|-3.74|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.64|-3.74|0.0057
71780747|NCT01817530|143061421|SUPERIORITY||Odds Ratio (OR)|17.21|||<|0.001|TWO_SIDED|95.0|6.57|45.05||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||45.05|6.57|< 0.001
71780748|NCT01817530|143061421|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780749|NCT01817530|143061421|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.001|TWO_SIDED|95.0|3.79|19.92||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||19.92|3.79|< 0.001
71780750|NCT01817530|143061421|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71891449|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.033|TWO_SIDED|95.0|0.002|0.055||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.055|0.002|0.0330
71748385|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
71748386|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.8||0.0006|TWO_SIDED|95.0|-4.38|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.22|-4.38|0.0006
71748387|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0412|TWO_SIDED|95.0|-3.21|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.07|-3.21|0.0412
71780751|NCT01817530|143061421|SUPERIORITY||Odds Ratio (OR)|18.67|||<|0.001|TWO_SIDED|95.0|7.11|49.02||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||49.02|7.11|< 0.001
71780752|NCT01817530|143061421|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780753|NCT01817530|143061421|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.43|10.04||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||10.04|2.43|< 0.001
71780754|NCT01817530|143061421|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780755|NCT01817530|143061421|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.001|TWO_SIDED|95.0|5.17|26.79|||Regression, Logistic|P value is from a logistic regression model including treatment as the main effect and baseline value as a covariate.||||26.79|5.17|< 0.001
71780756|NCT01817530|143061421|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780757|NCT01817530|143061422|SUPERIORITY||Odds Ratio (OR)|31.48|||<|0.001|TWO_SIDED|95.0|10.02|98.83||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||98.83|10.02|< 0.001
71780758|NCT01817530|143061422|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780759|NCT01817530|143061422|SUPERIORITY||Odds Ratio (OR)|14.39|||<|0.001|TWO_SIDED|95.0|5.77|35.91||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||35.91|5.77|< 0.001
71748388|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.79||0.0054|TWO_SIDED|95.0|-3.76|-0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.66|-3.76|0.0054
71748389|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.78||0.0167|TWO_SIDED|95.0|-3.43|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.34|-3.43|0.0167
71748390|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.75||0.0533|TWO_SIDED|95.0|-2.94|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.02|-2.94|0.0533
71748391|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.0065|TWO_SIDED|95.0|-3.54|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.58|-3.54|0.0065
71748392|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.76||0.0025|TWO_SIDED|95.0|-3.8|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.82|-3.80|0.0025
71748393|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.77||0.0005|TWO_SIDED|95.0|-4.22|-1.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.20|-4.22|0.0005
71780760|NCT01817530|143061422|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780761|NCT01817530|143061422|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.001|TWO_SIDED|95.0|4.23|22.8||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||22.8|4.23|< 0.001
71780762|NCT01817530|143061422|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71748394|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.77||0.0541|TWO_SIDED|95.0|-2.99|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.03|-2.99|0.0541
71748395|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.76||0.0039|TWO_SIDED|95.0|-3.69|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.71|-3.69|0.0039
71748396|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.75||0.0245|TWO_SIDED|95.0|-3.18|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.22|-3.18|0.0245
71748397|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.78||0.0187|TWO_SIDED|95.0|-3.36|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.31|-3.36|0.0187
71748398|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-3.68|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.62|-3.68|0.0060
71780763|NCT01817530|143061422|SUPERIORITY||Odds Ratio (OR)|16.58|||<|0.001|TWO_SIDED|95.0|6.66|41.26||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||41.26|6.66|< 0.001
71780764|NCT01817530|143061422|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780765|NCT01817530|143061422|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.36|14.68||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||14.68|3.36|< 0.001
71780766|NCT01817530|143061422|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780767|NCT01817530|143061422|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.001|TWO_SIDED|95.0|4.85|23.76||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||||23.76|4.85|< 0.001
71780768|NCT01817530|143061422|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a chi-square test.|Chi-squared|||||||< 0.001
71780769|NCT01817530|143061423|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71666728|NCT03971474|142848131|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.05|TWO_SIDED|80.0|0.51|0.92||If either P value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the standard stratified log-rank test.||0.92|0.51|0.05
71666729|NCT03971474|142848131|SUPERIORITY|||||||0.15||||||If either p-value from the two tests (standard stratified log-rank and weighted log-rank) was \< 0.0972, the study would be considered to have rejected the null at the one-sided 10% level.|Log Rank|||Comparison of OS was performed using a standard stratified log-rank test and a weighted log-rank test. The study had 90% power to detect the scenario with overlapping curves up to 3 months and a hazard ratio of 0.5 after 3 months, assuming exponentially distributed survival times, a median OS of 10.5 months in the SOC arm, and uniform accrual over 21-24 months. This analysis reports the weighted log-rank test.||||0.15
71666730|NCT03971474|142848132|SUPERIORITY|||||||0.19||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.19
71666731|NCT03971474|142848133|SUPERIORITY|||||||0.38||||||Proportions were compared using a chi-squared test at the one-sided 5% level.|Chi-squared|||||||0.38
71666732|NCT03971474|142848136|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.25|TWO_SIDED|80.0|0.66|1.14|||Log Rank|Testing was performed using a standard stratified log-rank test.|Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model including the stratification factors (PD-L1 status and histology) and 80% CIs.|Comparison of IA-PFS was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the standard stratified log-rank test.||1.14|0.66|0.25
71666733|NCT03971474|142848136|SUPERIORITY|||||||0.14|||||||Log Rank|Testing was performed using a weighted log-rank test.||Comparison of IA-PFS between the RP and SOC arms was performed using a standard stratified log-rank test and a weighted log-rank test with weights equal to 1-S(t), where S(t) is the pooled survival estimate at time t (G\[rho=0, gamma=1\]). The weighted test weights later events over earlier events and has more power than the standard log-rank test under a delayed separation in the curves. This analysis reports the weighted log-rank test.||||0.14
71666734|NCT03971474|142848137|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.16|TWO_SIDED|80.0|0.5|1.1||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.10|0.50|0.16
71666735|NCT03971474|142848137|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.08|TWO_SIDED|80.0|0.45|0.97||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.97|0.45|0.08
71666736|NCT03971474|142848137|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|80.0|0.28|0.65||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.65|0.28|0.005
71666737|NCT03971474|142848137|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.43|TWO_SIDED|80.0|0.67|1.35||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.35|0.67|0.43
71666738|NCT03971474|142848138|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.28|TWO_SIDED|80.0|0.58|1.22||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \< 1% subgroup.||1.22|0.58|0.28
71666739|NCT03971474|142848138|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.07|TWO_SIDED|80.0|0.48|0.95||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the PD-L1 \>= 1% subgroup.||0.95|0.48|0.07
71748399|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.78||0.0014|TWO_SIDED|95.0|-4.06|-0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.98|-4.06|0.0014
71748400|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.49|-1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.37|-4.49|0.0003
71748401|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.01|TWO_SIDED|95.0|-3.61|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-3.61|0.0100
71748402|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.78||0.0019|TWO_SIDED|95.0|-3.98|-0.91||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.91|-3.98|0.0019
71780770|NCT01817530|143061423|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780771|NCT01817530|143061423|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780772|NCT01817530|143061423|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71666740|NCT03971474|142848138|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.02|TWO_SIDED|80.0|0.38|0.8||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the squamous histology subgroup.||0.80|0.38|0.02
71780773|NCT01817530|143061423|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71748403|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.78||0.0049|TWO_SIDED|95.0|-3.73|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.67|-3.73|0.0049
71748404|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.0186|TWO_SIDED|95.0|-3.25|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.30|-3.25|0.0186
71748405|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.75||0.0024|TWO_SIDED|95.0|-3.77|-0.82||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.82|-3.77|0.0024
71748406|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.76||0.0003|TWO_SIDED|95.0|-4.28|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.30|-4.28|0.0003
71748407|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|0.77||0.0003|TWO_SIDED|95.0|-4.3|-1.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.29|-4.30|0.0003
71748408|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.76||0.0058|TWO_SIDED|95.0|-3.63|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-3.63|0.0058
71748409|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.75||0.0008|TWO_SIDED|95.0|-4.04|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.7|-4.04|0.0008
71748410|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.59|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.64|-3.59|0.0050
71748411|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0205|TWO_SIDED|95.0|-3.63|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.31|-3.63|0.0205
71748412|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.85||0.2818|TWO_SIDED|95.0|-2.58|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.75|-2.58|0.2818
71748413|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.87||0.3102|TWO_SIDED|95.0|-2.6|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.83|-2.60|0.3102
71748414|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.87||0.1422|TWO_SIDED|95.0|-2.99|0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.43|-2.99|0.1422
71748415|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.87||0.0064|TWO_SIDED|95.0|-4.12|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.68|-4.12|0.0064
71748416|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0752|TWO_SIDED|95.0|-3.28|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.16|-3.28|0.0752
71748417|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.85||0.3632|TWO_SIDED|95.0|-2.43|0.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.89|-2.43|0.3632
71780774|NCT01817530|143061423|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780775|NCT01817530|143061424|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780776|NCT01817530|143061424|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780777|NCT01817530|143061424|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780778|NCT01817530|143061424|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780779|NCT01817530|143061424|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71780780|NCT01817530|143061424|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71891450|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.4327|TWO_SIDED|95.0|-0.016|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.037|-0.016|0.4327
71891451|NCT01431287|143304559|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.013||0.1764|TWO_SIDED|95.0|-0.008|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.044|-0.008|0.1764
71748418|NCT03192176|143005294|SUPERIORITY||LSMean differencce|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0625|TWO_SIDED|95.0|-3.32|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-3.32|0.0625
71748419|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.86||0.6613|TWO_SIDED|95.0|-2.07|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.32|-2.07|0.6613
71748420|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.4209|TWO_SIDED|95.0|-2.48|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.04|-2.48|0.4209
71748421|NCT03192176|143005294|SUPERIORITY||LSMean differencce|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.3288|TWO_SIDED|95.0|-2.63|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.88|-2.63|0.3288
71748422|NCT03192176|143005294|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.9||0.0202|TWO_SIDED|95.0|-3.86|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.33|-3.86|0.0202
71748423|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0682|TWO_SIDED|95.0|-3.42|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-3.42|0.0682
71748424|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86||0.3912|TWO_SIDED|95.0|-2.44|0.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.96|-2.44|0.3912
71780781|NCT01817530|143061425|SUPERIORITY||difference in LS mean change|-3.7|STANDARD_ERROR_OF_MEAN|1.32||0.007|TWO_SIDED|95.0|-6.28|-1.03||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-1.03|-6.28|0.007
71748425|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4964|TWO_SIDED|95.0|-2.25|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.09|-2.25|0.4964
71748426|NCT03192176|143005294|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.84||0.983|TWO_SIDED|95.0|-1.64|1.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.68|-1.64|0.9830
71748427|NCT03192176|143005294|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9715|TWO_SIDED|95.0|-1.71|1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.78|-1.71|0.9715
71748428|NCT03192176|143005294|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.87||0.8715|TWO_SIDED|95.0|-1.58|1.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.86|-1.58|0.8715
71748429|NCT03192176|143005294|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.89||0.2233|TWO_SIDED|95.0|-2.83|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.66|-2.83|0.2233
71780782|NCT01817530|143061425|SUPERIORITY||difference in LS mean change|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.132|TWO_SIDED|95.0|-3.44|0.46||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.46|-3.44|0.132
71780783|NCT01817530|143061425|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.94||0.876|TWO_SIDED|95.0|-1.71|2.0||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||2.00|-1.71|0.876
71666741|NCT03971474|142848138|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|80.0|0.69|1.29||One-sided p-values were calculated using a standard log-rank test.|Log Rank||Treatment effects comparing the RP arm to the SOC arm were summarized using a Cox proportional hazards model and 80% CIs.|This analysis includes the results for the non-squamous histology subgroup.||1.29|0.69|0.41
71748430|NCT03192176|143005294|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.89||0.2882|TWO_SIDED|95.0|-2.69|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.80|-2.69|0.2882
71748431|NCT03192176|143005294|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.8643||95.0|-1.52|1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.80|-1.52|0.8643
71748432|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0104|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0104
71748433|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.006|TWO_SIDED|95.0|-0.56|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.09|-0.56|0.0060
71748434|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.71|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.24|-0.71|<0.0001
71780784|NCT01817530|143061425|SUPERIORITY||difference in LS mean change|-1.9|STANDARD_ERROR_OF_MEAN|1.0||0.055|TWO_SIDED|95.0|-3.92|0.04||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.04|-3.92|0.055
71748435|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.85|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.38|-0.85|<0.0001
71748436|NCT03192176|143005295|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.6977|TWO_SIDED|95.0|-0.28|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.19|-0.28|0.6977
71748437|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0121|TWO_SIDED|95.0|-0.53|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.07|-0.53|0.0121
71780785|NCT01817530|143061425|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.82||0.898|TWO_SIDED|95.0|-1.52|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|-1.52|0.898
71891452|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0241|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.007|0.0241
71891453|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.051|0.148||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.148|0.051|<0.0001
71891454|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.025||0.0049|TWO_SIDED|95.0|0.021|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.021|0.0049
71891455|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.196|0.098|<0.0001
71891456|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.064|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.162|0.064|<0.0001
71666742|NCT01937871|142848157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-2.25|-0.57||||||||-0.57|-2.25|
71666743|NCT01937871|142848161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-1.87|0.18||||||||0.18|-1.87|
71666744|NCT00207883|142848281|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71666745|NCT02359994|142848283|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in percentage of participants|-1.4||||0.005|TWO_SIDED|95.0|-7.5|4.8|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The primary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 7 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 7 minutes in the Arista group, the active control.||4.8|-7.5|0.005
71666746|NCT02359994|142848284|NON_INFERIORITY|Non-inferiority was assessed with a pre-specified non-inferiority margin of 10%, such that the endpoint is successfully met if the non-inferiority one-sided p-value is less than 0.025 or, equivalently, if the lower bound of a two-sided 95% confidence interval for the difference between PerClot and Arista hemostasis rates is greater than -10%.|Difference in Percentage of Participants|4.8|||<|0.001|TWO_SIDED|95.0|-2.4|12.0|||Farrington-Manning score test||Directionality for difference in the percentage of participants achieving endpoint: PerClot - Arista|The secondary efficacy hypothesis is that the percentage of participants achieving hemostasis of the treated bleeding site at 5 minutes in the overall PerClot group is non-inferior to the percentage of participants achieving hemostasis at 5 minutes in the Arista group, the active control.||12.0|-2.4|<0.001
71666747|NCT02213289|142848413|SUPERIORITY|||||||0.0024|||||||One-sided Z-test|This was a test of whether the observed 1-year survival rate was significantly different from historical 50% rate.||||||0.0024
71666748|NCT01579747|142848441|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Normality of distribution was assessed with the Shapiro-Wilk test. For normally-distributed continuous variables, the groups' distributions were described as means and standard deviations (SD). Student's t-test was used to compare groups in these cases with statistically-significant differences summarized using 95% confidence intervals as appropriate. For all comparisons, two-tailed p\<0.05 was considered statistically significant.||||<0.05
71666749|NCT04182334|142848442|SUPERIORITY|||||||0.775|||||||Mixed Models Analysis|||||||0.775
71666750|NCT04182334|142848443|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||||||0.995
71666751|NCT04182334|142848444|SUPERIORITY|||||||0.674|||||||Mixed Models Analysis|||||||0.674
71666752|NCT04182334|142848445|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||||||0.326
71748438|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0086|TWO_SIDED|95.0|-0.54|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.54|0.0086
71891457|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.025||0.5831|TWO_SIDED|95.0|-0.063|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.063|0.5831
71666753|NCT04182334|142848446|SUPERIORITY|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||||||0.463
71666754|NCT04182334|142848447|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
71666755|NCT04182334|142848448|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
71666756|NCT04182334|142848449|SUPERIORITY|||||||0.612|||||||Wilcoxon (Mann-Whitney)|||||||0.612
71666757|NCT04182334|142848450|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
71780786|NCT01817530|143061425|SUPERIORITY||difference in LS mean change|-0.4|STANDARD_ERROR_OF_MEAN|0.81||0.59|TWO_SIDED|95.0|-2.05|1.17||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.17|-2.05|0.59
71666758|NCT04182334|142848451|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
71666759|NCT01950390|142848461|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.383|ONE_SIDED|90.0||1.23||One-sided|Log Rank|Stratification factors of BRAF mutation status (wild type/mutation) and prior therapy (yes/no) were used in the stratified analysis|One-sided 90% Repeated Confidence Interval for Hazard Ratio with Arm A as Reference|||1.23||0.383
71666760|NCT01950390|142848462|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.61|1.2||Two-sided|Log Rank|Stratified Log rank test||||1.20|0.61|0.358
71666761|NCT01950390|142848463|SUPERIORITY|||||||0.482||||||Two-sided|Chi-squared|||||||0.482
71666762|NCT01950390|142848465|SUPERIORITY|||||||0.937||||||Two-sided|Chi-squared|||||||0.937
71666763|NCT02969382|142848554|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.23||0.001|TWO_SIDED|95.0|-11.9|-3.0|||Mixed Models Analysis|||||-3.0|-11.9|0.001
71666764|NCT02969382|142848555|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
71666765|NCT02969382|142848556|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.71||0.019|TWO_SIDED|95.0|-3.1|-0.3|||Mixed Models Analysis|||||-0.3|-3.1|0.019
71666766|NCT02969382|142848557|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.55||0.008|TWO_SIDED|95.0|-2.6|-0.4|||Mixed Models Analysis|||||-0.4|-2.6|0.008
71666767|NCT02969382|142848558|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-6.6|-2.0|||Mixed Models Analysis|||||-2.0|-6.6|<0.001
71666768|NCT02969382|142848559|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|1.26|<|0.001|TWO_SIDED|95.0|-6.8|-1.8|||Mixed Models Analysis|||||-1.8|-6.8|<0.001
71666769|NCT02969382|142848560|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.75||0.02|TWO_SIDED|95.0|-3.2|-0.3|||Mixed Models Analysis|||||-0.3|-3.2|0.020
71666770|NCT02969382|142848561|SUPERIORITY||Odds Ratio (OR)|2.645||||0.002|TWO_SIDED|95.0|1.422|4.921|||Regression, Logistic|||||4.921|1.422|0.002
71666771|NCT02969382|142848563|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
71666772|NCT02969382|142848564|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71666773|NCT02969382|142848565|OTHER|||||||0.498|||||||Fisher Exact|||||||0.498
71666774|NCT00886015|142848572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.96|1.93||||||||1.93|0.96|
71666775|NCT00886015|142848573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.46|0.98||||||||0.98|0.46|
71666776|NCT00886015|142848574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.66|1.18||||||||1.18|0.66|
71666777|NCT00886015|142848575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.44|0.98||||||||0.98|0.44|
71666778|NCT00886015|142848576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.42|0.97||||||Mild ECA compared with Normal||0.97|0.42|
71666779|NCT00886015|142848576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.39|1.01||||||Moderate ECA compared with Normal||1.01|0.39|
71666780|NCT00886015|142848576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.35|1.1||||||Severe ECA compared with Normal||1.10|0.35|
71666781|NCT00886015|142848577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.97|1.53||||||||1.53|0.97|
71666782|NCT01983566|142848587|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|115.8||||0.3944|TWO_SIDED|90.0|63.52|211.11||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% confidence interval (CI) based on the t-distribution was computed.~These were then back transformed. The estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||211.11|63.52|0.3944
71666783|NCT01983566|142848588|NON_INFERIORITY_OR_EQUIVALENCE|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|114.83||||0.3674|TWO_SIDED|90.0|74.803|176.281||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% CI based on the t-distribution was computed.~These were then back transformed. This estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."||176.281|74.803|0.3674
71666784|NCT01473407|142848593|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.25|0.01||||||Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.||0.01|-0.25|
71666785|NCT01473407|142848594|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|5.483|||TWO_SIDED|95.0|-10.4|11.13||||||LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.||11.13|-10.40|
71666786|NCT01473407|142848595|SUPERIORITY_OR_OTHER|||||||0.7563||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.7563
71666787|NCT01473407|142848596|SUPERIORITY_OR_OTHER|||||||0.1061||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.1061
71666788|NCT01473407|142848597|SUPERIORITY_OR_OTHER|||||||0.3369||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test|||||||0.3369
71677379|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.876|||||TWO_SIDED|95.0|0.61|1.26||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.260|0.610|
71748439|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0138|TWO_SIDED|95.0|-0.66|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.08|-0.66|0.0138
71748440|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0014|TWO_SIDED|95.0|-0.78|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.19|-0.78|0.0014
71748441|NCT03192176|143005295|SUPERIORITY||LSMean differencce|-0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.02|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.43|-1.02|<0.0001
71748442|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.19|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-1.19|<0.0001
71748443|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.2831|TWO_SIDED|95.0|-0.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.14|-0.46|0.2831
71748444|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0051|TWO_SIDED|95.0|-0.72|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.13|-0.72|0.0051
71748445|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.81|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.22|-0.81|0.0006
71780787|NCT01817530|143061426|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.31||0.001|TWO_SIDED|95.0|-1.64|-0.42||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.42|-1.64|0.001
71891458|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.133|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.182||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.182|0.084|<0.0001
71891459|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0822|TWO_SIDED|95.0|-0.092|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.006|-0.092|0.0822
71748446|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0058|TWO_SIDED|95.0|-0.83|-0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.14|-0.83|0.0058
71748447|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0004|TWO_SIDED|95.0|-0.97|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.28|-0.97|0.0004
71748448|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.46|-1.14|<0.0001
71748449|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.27|-0.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.57|-1.27|<0.0001
71748450|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0807|TWO_SIDED|95.0|-0.66|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.04|-0.66|0.0807
71748451|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0014|TWO_SIDED|95.0|-0.91|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.22|-0.91|0.0014
71780788|NCT01817530|143061426|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.42|-0.48||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.48|-1.42|< 0.001
71666789|NCT01027702|142848717|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~* If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~* If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~* If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
71666790|NCT01027702|142848718|OTHER|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~1. Probability of CD4+ cells \> 100/µL by Day +120 is at least 66% and~2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and \< 2/3 had a CD4+ count \> 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \> 2/3 have a CD4+ count \> 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10\^4 CD3+ cells/kg was determined to be the optimal dose."|||
71666791|NCT00403585|142848721|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 156.|Wilcoxon signed rank|||||||<0.001
71666792|NCT02964312|142848737|SUPERIORITY||Proportion|89.5|||||TWO_SIDED|95.0|83.5|93.9||||||The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level \>90%.||93.9|83.5|
71666793|NCT02964312|142848740|SUPERIORITY||||||<|0.001||||||P values are based on paired t-tests for change from baseline with p\<0.05 indicating significance.|t-test, 2 sided|||||||<0.001
71666794|NCT01023035|142848784|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-8.6|7.2|||Mantel-Haenszel, modified Koch method|||The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.||7.2|-8.6|
71666795|NCT03127514|142848796|SUPERIORITY|||||||0.03||||||A two-tailed P value of 0.05 or less was considered to indicate statistical significance.|Mixed Models Analysis|Random-slope, shared-baseline, linear mixed model was adjusted for age and prebaseline ALSFRS-R slope||||||0.03
71666796|NCT02413229|142848816|SUPERIORITY|||||||0.3571|||||||Cochran-Mantel-Haenszel|||||||0.3571
71666797|NCT02413229|142848816|SUPERIORITY|||||||0.5224|||||||Cochran-Mantel-Haenszel|||||||0.5224
71666798|NCT02413229|142848816|SUPERIORITY|||||||0.389|||||||Cochran-Mantel-Haenszel|||||||0.3890
71666799|NCT02413229|142848816|SUPERIORITY|||||||0.0325|||||||Cochran-Mantel-Haenszel|||||||.0325
71666800|NCT02932462|142848817|SUPERIORITY|||||||0.4557|||||||Cochran-Mantel-Haenszel|||||||0.4557
71780789|NCT01817530|143061426|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|95.0|-1.12|-0.25||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.25|-1.12|0.002
71666801|NCT02932462|142848818|SUPERIORITY|||||||0.8096|||||||Cochran-Mantel-Haenszel|||||||0.8096
71666802|NCT02932462|142848819|SUPERIORITY|||||||0.7652|||||||Cochran-Mantel-Haenszel|||||||0.7652
71666803|NCT02652949|142848820|SUPERIORITY||Event rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
71666804|NCT03022370|142848828|SUPERIORITY||Odds Ratio (OR)|0.92|||=|0.686|TWO_SIDED|95.0|0.62|1.37|||Regression, Logistic|||||1.37|0.62|=0.686
71666805|NCT03022370|142848828|SUPERIORITY||Odds Ratio (OR)|0.71|||=|0.032|TWO_SIDED|95.0|0.51|0.97|||Regression, Logistic|||||0.97|0.51|=0.032
71666806|NCT03022370|142848829|SUPERIORITY||Odds Ratio (OR)|0.9||||0.555|TWO_SIDED|95.0|0.64|1.28|||Regression, Logistic|||||1.28|0.64|0.555
71666807|NCT03022370|142848829|SUPERIORITY||Odds Ratio (OR)|0.74||||0.072|TWO_SIDED|95.0|0.54|1.03|||Regression, Logistic|||||1.03|0.54|0.072
71666808|NCT03022370|142848830|SUPERIORITY||Odds Ratio (OR)|0.93||||0.672|TWO_SIDED|95.0|0.66|1.31|||Regression, Logistic|||||1.31|0.66|0.672
71666809|NCT03022370|142848830|SUPERIORITY||Odds Ratio (OR)|0.7||||0.019|TWO_SIDED|95.0|0.52|0.94|||Regression, Logistic|||||0.94|0.52|0.019
71666810|NCT03022370|142848831|SUPERIORITY||Slope|-0.01||||0.984|TWO_SIDED|95.0|-0.88|0.86|||Regression, Linear|||||0.86|-0.88|0.984
71666811|NCT03022370|142848831|SUPERIORITY||Slope|0.06||||0.839|TWO_SIDED|95.0|-0.51|0.63|||Regression, Linear|||||0.63|-0.51|0.839
71666812|NCT03022370|142848832|SUPERIORITY||Slope|0.97|||<|0.0001|TWO_SIDED|95.0|0.43|1.51|||Tobit|Log + 1 performed on data||||1.51|0.43|<0.0001
71666813|NCT03022370|142848832|SUPERIORITY||Slope|0.21||||0.521|TWO_SIDED|95.0|-0.42|0.83|||Tobit|Log plus 1 to transform data||||0.83|-0.42|0.521
71666814|NCT03022370|142848833|SUPERIORITY||Slope|0.25||||0.718|TWO_SIDED|95.0|-1.09|1.58|||Regression, Linear|||||1.58|-1.09|0.718
71780790|NCT01817530|143061426|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.29||0.118|TWO_SIDED|95.0|-1.04|0.12||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||0.12|-1.04|0.118
71666815|NCT03022370|142848833|SUPERIORITY||Slope|-0.3||||0.712|TWO_SIDED|95.0|-1.87|1.28|||Regression, Linear|||||1.28|-1.87|0.712
71666816|NCT03022370|142848834|SUPERIORITY||Slope|-1.52||||0.067|TWO_SIDED|95.0|-3.14|0.11|||Regression, Linear|||||0.11|-3.14|0.067
71666817|NCT03022370|142848834|SUPERIORITY||Slope|-0.75||||0.398|TWO_SIDED|95.0|-2.48|0.99|||Regression, Linear|||||0.99|-2.48|0.398
71666818|NCT03022370|142848835|SUPERIORITY||Odds Ratio (OR)|1.29||||0.228|TWO_SIDED|95.0|0.85|1.97|||Regression, Logistic|||||1.97|0.85|0.228
71666819|NCT03022370|142848835|SUPERIORITY||Odds Ratio (OR)|0.86||||0.558|TWO_SIDED|95.0|0.53|1.41|||Regression, Logistic|||||1.41|0.53|0.558
71666820|NCT03022370|142848836|SUPERIORITY||Slope|0.14||||0.679|TWO_SIDED|95.0|-0.52|0.8|||Regression, Linear|||||0.80|-0.52|0.679
71666821|NCT03022370|142848836|SUPERIORITY||Slope|0.55||||0.08|TWO_SIDED|95.0|-0.07|1.16|||Regression, Linear|||||1.16|-0.07|0.08
71666822|NCT03022370|142848837|SUPERIORITY||Slope|-0.13||||0.81|TWO_SIDED|95.0|-1.21|0.95|||Regression, Linear|||||0.95|-1.21|0.810
71666823|NCT03022370|142848837|SUPERIORITY||Slope|-1.03||||0.041|TWO_SIDED|95.0|-2.01|-0.04|||Regression, Linear|||||-0.04|-2.01|0.041
71666824|NCT03022370|142848838|SUPERIORITY||Odds Ratio (OR)|1.14||||0.635|TWO_SIDED|95.0|0.67|1.92|||Regression, Logistic|||||1.92|0.67|0.635
71666825|NCT03022370|142848838|SUPERIORITY||Odds Ratio (OR)|0.72||||0.256|TWO_SIDED|95.0|0.41|1.27|||Regression, Logistic|||||1.27|0.41|0.256
71835110|NCT01631214|143174831|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.4|4.14|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.14|3.40|<0.001
71666826|NCT03022370|142848839|SUPERIORITY||Odds Ratio (OR)|1.16||||0.526|TWO_SIDED|95.0|0.73|1.84|||Regression, Logistic|||||1.84|0.73|0.526
71891460|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.025||0.002|TWO_SIDED|95.0|-0.126|-0.028||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||-0.028|-0.126|0.0020
71891461|NCT01431287|143304560|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.034|STANDARD_ERROR_OF_MEAN|0.025||0.1774|TWO_SIDED|95.0|-0.015|0.083||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.083|-0.015|0.1774
71666827|NCT03022370|142848839|SUPERIORITY||Odds Ratio (OR)|1.02||||0.931|TWO_SIDED|95.0|0.67|1.56|||Regression, Logistic|||||1.56|0.67|0.931
71666828|NCT03022370|142848840|SUPERIORITY||Odds Ratio (OR)|0.92||||0.691|TWO_SIDED|95.0|0.63|1.36|||Regression, Logistic|||||1.36|0.63|0.691
71666829|NCT03022370|142848840|SUPERIORITY||Odds Ratio (OR)|0.92||||0.692|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||||1.40|0.60|0.692
71666830|NCT03022370|142848841|SUPERIORITY||Slope|-0.31||||0.137|TWO_SIDED|95.0|-0.72|0.24|||Regression, Linear|||||0.24|-0.72|0.137
71666831|NCT03022370|142848841|SUPERIORITY||Slope|-0.09||||0.721|TWO_SIDED|95.0|-0.58|0.4|||Regression, Linear|||||0.40|-0.58|0.721
71666832|NCT03022370|142848842|SUPERIORITY||Slope|-0.23||||0.332|TWO_SIDED|95.0|-0.7|0.24|||Regression, Linear|||||0.24|-0.70|0.332
71666833|NCT03022370|142848842|SUPERIORITY||Slope|-0.19||||0.468|TWO_SIDED|95.0|-0.71|0.32|||Regression, Linear|||||0.32|-0.71|0.468
71666834|NCT03022370|142848843|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
71666835|NCT03022370|142848843|SUPERIORITY||Odds Ratio (OR)|1.49||||0.129|TWO_SIDED|95.0|0.89|2.5|||Regression, Logistic|||||2.50|0.89|0.129
71666836|NCT03022370|142848844|SUPERIORITY||Odds Ratio (OR)|1.3||||0.174|TWO_SIDED|95.0|0.89|1.9|||Regression, Logistic|||||1.90|0.89|0.174
71666837|NCT03022370|142848844|SUPERIORITY||Odds Ratio (OR)|0.96||||0.836|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||||1.43|0.64|0.836
71666838|NCT00699816|142848845|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.01|TWO_SIDED|95.0|0.43|0.94|||Log Rank|||||0.94|0.43|0.01
71666839|NCT00699816|142848846|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.008|TWO_SIDED|95.0|0.06|0.75|||Log Rank|||||0.75|0.06|0.008
71666840|NCT00699816|142848847|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.19||||0.02|TWO_SIDED|95.0|0.04|0.87|||Log Rank|||||0.87|0.04|0.02
71666841|NCT01311687|142848852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.35|0.59|||Stratified Log Rank Test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.35|<0.001
71666842|NCT01311687|142848853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.39|0.61|||Stratified log-rank test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.61|0.39|<0.001
71666843|NCT01311687|142848855|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.74|0.37|<0.001
71666844|NCT01311687|142848856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.009|TWO_SIDED|95.0|0.54|0.92|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.92|0.54|0.009
71666845|NCT01311687|142848857|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.91|0.60|0.005
71666846|NCT01311687|142848858|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.53|||<|0.001|TWO_SIDED|95.0|3.19|17.77|||Fisher Exact||Odds ratio is for pomalidomide plus low-dose dexamethasone : high dose dexamethasone|||17.77|3.19|< 0.001
71748452|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17||0.0001|TWO_SIDED|95.0|-1.02|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.34|-1.02|0.0001
71748453|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0046|TWO_SIDED|95.0|-0.85|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.16|-0.85|0.0046
71748454|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-0.99|-0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.29|-0.99|0.0003
71748455|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.45|-1.14|<0.0001
71748456|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.14|-0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.70|-1.14|<0.0001
71666847|NCT01311687|142848859|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.44|||<|0.001|TWO_SIDED|95.0|3.32|21.42|||Fisher Exact||Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||21.42|3.32|< 0.001
71666848|NCT01311687|142848860|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.36|0.59|||Stratified Log Rank Test|Stratified by age, diseases population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone|||0.59|0.36|< 0.001
71666849|NCT01526655|142848877|SUPERIORITY|||||||0.011||||||Main effect over time p\<0.001; Interaction effect p=0.65. Threshold for statistical significance p\<0.05|ANOVA|||||||0.011
71666850|NCT01526655|142848878|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p 0.02.~Threshold for statistical significance p\<0.05."|ANOVA||||Tukey post hoc test (p-values): hsCRP time 4 p 0.02; hsCRP time 5 p \<0.001.|||0.03
71666851|NCT01526655|142848879|SUPERIORITY||||||<|0.01||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.0001.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): WBC time 3 p \< 0.0001.|||<0.01
71666852|NCT01526655|142848880|SUPERIORITY|||||||0.03|||||||ANOVA||||Tukey post hoc test (p-value): IL-6 time 3 p \< 0.01.|||0.03
71666853|NCT01526655|142848881|SUPERIORITY|||||||0.03||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): CK time 4 p \< 0.0001.|||0.03
71666854|NCT01526655|142848882|SUPERIORITY|||||||0.06||||||"P-value main effect between groups. Effect over time p \< 0.0001. Interaction effect p \< 0.01.~Threshold for statistical significance p \< 0.05."|ANOVA||||Tukey post hoc test (p-value): cortisol time 3 p \< 0.0001.|||0.06
71666855|NCT01526655|142848883|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71666856|NCT01526655|142848884|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71748457|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0209|TWO_SIDED|95.0|-0.77|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.06|-0.77|0.0209
71748458|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_DEVIATION|0.18||0.0011|TWO_SIDED|95.0|-0.93|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.24|-0.93|0.0011
71748459|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.38|-1.07|<0.0001
71748460|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.67|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.67|0.0956
71780791|NCT01817530|143061426|SUPERIORITY||difference in LS mean change|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.22|-1.16|0.004
71780792|NCT01817530|143061426|SUPERIORITY||difference in LS mean change|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.51|-0.59||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||-0.59|-1.51|< 0.001
71666857|NCT04020887|142848901|SUPERIORITY||Median Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-6.01|18.01||||||Difference in time to PACU discharge determination from observation to interaction phase \[ Time Frame: 6 months\]: The difference in discharge readiness time between the observation and interaction phases will be compared.||18.01|-6.01|
71666858|NCT04020887|142848902|SUPERIORITY||Difference Between Proportions|29.8|||||TWO_SIDED|95.0|23.82|35.66||||||||35.66|23.82|
71666859|NCT04020887|142848903|SUPERIORITY||Difference Between Proportions|-2.67|||||TWO_SIDED|95.0|-8.18|3.02||||||||3.02|-8.18|
71666860|NCT04020887|142848904|SUPERIORITY||Difference Between Proportions|13.03|||||TWO_SIDED|95.0|5.16|20.79||||||||20.79|5.16|
71666861|NCT04020887|142848905|SUPERIORITY||Difference Between Proportions|0.51|||||TWO_SIDED|95.0|-1.63|3.07||||||||3.07|-1.63|
71666862|NCT04020887|142848906|SUPERIORITY||Difference Between Proportions|7.9|||||TWO_SIDED|95.0|3.13|12.71||||||||12.71|3.13|
71666863|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.23||||0.001|TWO_SIDED|95.0|2.04|5.13|||t-test, 2 sided|||Sevoflurane administration in developing postoperative headache||5.13|2.04|0.001
71666864|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.006|TWO_SIDED|95.0|1.19|2.84|||t-test, 2 sided|||Smoking as a factor for developing postoperative headache||2.84|1.19|0.006
71666865|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|2.11||||0.008|TWO_SIDED|95.0|1.22|3.66|||t-test, 2 sided|||Intraoperative hypotension associated with postoperative headache in total sample||3.66|1.22|0.008
71666866|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.024|TWO_SIDED|95.0|1.08|3.15|||t-test, 2 sided|||Female gender as a factor for developing postoperative headache||3.15|1.08|0.024
71666867|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.56||||0.005|TWO_SIDED|95.0|1.58|13.17|||t-test, 2 sided|||Association of female gender and postoperative headache||13.17|1.58|0.005
71666868|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.79||||0.006|TWO_SIDED|95.0|1.48|9.72|||t-test, 2 sided|||Association of intraoperative hypotension and postoperative headache||9.72|1.48|0.006
71666869|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.86||||0.041|TWO_SIDED|95.0|1.06|14.06|||t-test, 2 sided|||Association of caffeine consumption and postoperative headache||14.06|1.06|0.041
71666870|NCT02374346|142848931|NON_INFERIORITY_OR_EQUIVALENCE|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student's t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.26||||0.001|TWO_SIDED|95.0|1.82|9.95|||t-test, 2 sided|||Association of sevoflurane administration and postoperative headache||9.95|1.82|0.001
71666871|NCT04807400|142848932|SUPERIORITY||Least Squares Mean|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-37.91|-25.77||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.77|-37.91|<0.001
71666872|NCT04807400|142848932|SUPERIORITY||Least Squares Mean|-32.1|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-38.35|-25.94||p-values are adjusted using Holm's procedure.|ANCOVA|||||-25.94|-38.35|<0.001
71666873|NCT04807400|142848934|SUPERIORITY||Least-squares Mean|1.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|0.62|2.13|||ANOVA|||||2.13|0.62|<0.001
71666874|NCT04807400|142848934|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|0.6|2.1|||ANOVA|||||2.10|0.60|<0.001
71666875|NCT04807400|142848935|SUPERIORITY||Least-squares Mean|-0.03|STANDARD_ERROR_OF_MEAN|0.326||0.9347|TWO_SIDED|95.0|-0.67|0.61|||ANOVA|||||0.61|-0.67|0.9347
71666876|NCT04807400|142848936|SUPERIORITY||Least-squares Mean|1.0|STANDARD_ERROR_OF_MEAN|2.34||0.6759|TWO_SIDED|95.0|-3.62|5.58|||ANCOVA|||||5.58|-3.62|0.6759
71666877|NCT04807400|142848936|SUPERIORITY||Least-squares Mean|1.3|STANDARD_ERROR_OF_MEAN|2.31||0.5756|TWO_SIDED|95.0|-3.25|5.84|||ANCOVA|||||5.84|-3.25|0.5756
71666878|NCT04807400|142848937|SUPERIORITY||Least-squares Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69||0.858|TWO_SIDED|95.0|-3.02|3.62|||ANCOVA|||||3.62|-3.02|0.8580
71666879|NCT03656744|142848941|SUPERIORITY|||||||0.199|||||||ANCOVA|||||||0.199
71666880|NCT03656744|142848941|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
71666881|NCT03656744|142848942|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
71666882|NCT03656744|142848942|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||0.109
71666883|NCT03656744|142848943|SUPERIORITY|||||||0.034|||||||ANCOVA|||||||0.034
71666884|NCT03656744|142848943|SUPERIORITY|||||||0.004|||||||ANCOVA|||||||0.004
71666885|NCT03656744|142848944|SUPERIORITY|||||||0.884|||||||Regression, Logistic|||||||0.884
71666886|NCT03656744|142848944|SUPERIORITY|||||||0.236|||||||Regression, Logistic|||||||0.236
71666887|NCT03656744|142848945|SUPERIORITY|||||||0.196|||||||ANCOVA|||||||0.196
71666888|NCT03656744|142848945|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
71666889|NCT03656744|142848946|SUPERIORITY|||||||0.294|||||||Cochran-Mantel-Haenszel|||||||0.294
71666890|NCT03656744|142848947|SUPERIORITY|||||||0.287|||||||Regression, Logistic|||||||0.287
71666891|NCT03656744|142848947|SUPERIORITY|||||||0.09|||||||Regression, Logistic|||||||0.090
71748461|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0050
71748462|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.18|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.45|-1.18|<0.0001
71748463|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.4|-0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.65|-1.40|<0.0001
71780793|NCT01817530|143061427|SUPERIORITY||difference in LS mean change|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.004|TWO_SIDED|95.0|-0.79|-0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||-0.15|-0.79|0.004
71666892|NCT03656744|142848948|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
71666893|NCT03656744|142848948|SUPERIORITY|||||||0.534|||||||ANCOVA|||||||0.534
71666894|NCT03656744|142848949|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
71666895|NCT03656744|142848949|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
71666896|NCT03656744|142848950|SUPERIORITY|||||||0.041|||||||ANCOVA|||||||0.041
71748464|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0915|TWO_SIDED|95.0|-0.69|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.69|0.0915
71666897|NCT03656744|142848950|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||0.120
71666898|NCT03656744|142848951|SUPERIORITY|||||||0.955|||||||ANCOVA|||||||0.955
71666899|NCT03656744|142848951|SUPERIORITY|||||||0.072|||||||ANCOVA|||||||0.072
71666900|NCT03656744|142848952|SUPERIORITY|||||||0.488|||||||ANCOVA|||||||0.488
71666901|NCT03656744|142848952|SUPERIORITY|||||||0.022|||||||ANCOVA|||||||0.022
71666902|NCT03656744|142848953|SUPERIORITY|||||||0.674|||||||ANCOVA|||||||0.674
71666903|NCT03656744|142848953|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.030
71666904|NCT03656744|142848954|SUPERIORITY|||||||0.588|||||||Regression, Logistic|||||||0.588
71666905|NCT03656744|142848954|SUPERIORITY|||||||0.103|||||||Regression, Logistic|||||||0.103
71666906|NCT03656744|142848955|SUPERIORITY|||||||0.236|||||||ANCOVA|||||||0.236
71666907|NCT03656744|142848955|SUPERIORITY|||||||0.944|||||||ANCOVA|||||||0.944
71666908|NCT03656744|142848956|SUPERIORITY|||||||0.267|||||||ANCOVA|||||||0.267
71666909|NCT03656744|142848956|SUPERIORITY|||||||0.911|||||||ANCOVA|||||||0.911
71666910|NCT03656744|142848957|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
71666911|NCT03656744|142848957|SUPERIORITY|||||||0.855|||||||ANCOVA|||||||0.855
71666912|NCT03656744|142848958|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||0.107
71666913|NCT03656744|142848958|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||0.489
71666914|NCT03656744|142848959|SUPERIORITY|||||||0.515|||||||ANCOVA|||||||0.515
71666915|NCT03656744|142848959|SUPERIORITY|||||||0.887|||||||ANCOVA|||||||0.887
71666916|NCT03656744|142848960|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
71666917|NCT03656744|142848960|SUPERIORITY|||||||0.016|||||||ANCOVA|||||||0.016
71666918|NCT03656744|142848961|SUPERIORITY|||||||0.124|||||||ANCOVA|||||||0.124
71666919|NCT03656744|142848961|SUPERIORITY|||||||0.171|||||||ANCOVA|||||||0.171
71666920|NCT03295630|142848998|OTHER||Mean Difference (Final Values)|-17.7|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count||||
71666921|NCT03295630|142848998|OTHER||Intraclass Correlation Coefficient|0.46|||||TWO_SIDED|95.0|-0.1|0.78||||||Correlation between accelerometer quantified step count (thigh placement) and observed step count||0.78|-0.1|
71666922|NCT03295630|142848998|OTHER||Mean Difference (Final Values)|-0.84|||||TWO_SIDED|||||||||Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count||||
71666923|NCT03295630|142848998|OTHER||Intraclass Correlation Coefficient|0.99|||||TWO_SIDED|95.0|0.99|1.0||||||Correlation between accelerometer quantified steps (ankle placement) and observed steps||1.0|0.99|
71748465|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0378|TWO_SIDED|95.0|-0.75|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.02|-0.75|0.0378
71748466|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0053|TWO_SIDED|95.0|-0.89|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.89|0.0053
71666924|NCT01330303|142849023|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.89||||||90.0|94.91|109.39|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.39|94.91|
71666925|NCT01330303|142849024|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.91||||||90.0|95.0|109.33|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||109.33|95.00|
71835111|NCT01631214|143174832|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|8.31|9.09|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||9.09|8.31|<0.001
71835112|NCT01631214|143174833|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|3.03|3.6|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.60|3.03|<0.001
71666926|NCT01330303|142849025|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.04||||||90.0|86.33|102.44|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.|||102.44|86.33|
71666927|NCT00125515|142849067|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||all statistical analysis were two tailed and employed an alpha significance level of 0.05.||||0.32
71666928|NCT03649347|142849072|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.720|ANOVA|Main effect of time: p\<.001, np2=.798; main effect of group: p\<.001, np2=.711||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=4.76.||||<.001
71666929|NCT03649347|142849073|SUPERIORITY||||||<|0.001||||||Interaction effect: p\<.001, np2=.542|ANOVA|Main effect of time: p\<.001, np2=.598; and main effect of group: p\<.001, np2=.439||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 96%, critical F=4.76.||||<.001
71666930|NCT03649347|142849075|SUPERIORITY||||||<|0.005||||||Interaction effect: p\<.005, np2=.481|ANOVA|Main effect of time: p\<.001, np2=.572; and main effect of group p\<.001, np2=.626||A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=3.49.||||<.005
71666931|NCT01866098|142849076|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.83
71666932|NCT01866098|142849077|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
71666933|NCT01866098|142849078|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.19
71666934|NCT01866098|142849079|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.96
71666935|NCT01866098|142849080|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.92
71666936|NCT01866098|142849081|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.98
71666937|NCT01866098|142849082|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.95
71666938|NCT01866098|142849083|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.||||||0.43
71666939|NCT02517463|142849100|NON_INFERIORITY_OR_EQUIVALENCE|"The PPP from a previous study was 67.2%. Assuming the PPP in the preovulatory and post-ovulatory groups were equivalent, and taking 10% to be the maximum permitted difference for equivalence, a minimum of 273 subjects in each group would be required to confirm equivalence between the two groups with a power of 80% and type I error of 0.05. Therefore, our recruitment of 700 subjects with more than 300 in each group was sufficient."|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71666940|NCT02517463|142849101|SUPERIORITY_OR_OTHER|||||||0.564|TWO_SIDED||||||Fisher Exact|||||||0.564
71666941|NCT02517463|142849102|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71666942|NCT03449446|142849105|SUPERIORITY||Difference in percentages|0.6||||0.9449|TWO_SIDED|95.0|-17.6|18.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted Mantel-Haenszel (MH) method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.8|-17.6|0.9449
71666943|NCT03449446|142849105|SUPERIORITY||Difference in percentages|0.4||||0.9646|TWO_SIDED|95.0|-17.6|18.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.4|-17.6|0.9646
71780794|NCT01817530|143061427|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.314|TWO_SIDED|95.0|-0.4|0.13||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.13|-0.4|0.314
71780795|NCT01817530|143061427|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.307|TWO_SIDED|95.0|-0.12|0.39||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.39|-0.12|0.307
71780796|NCT01817530|143061427|SUPERIORITY||difference in LS mean change|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.106|TWO_SIDED|95.0|-0.58|0.06||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.06|-0.58|0.106
71780797|NCT01817530|143061427|SUPERIORITY||difference in LS mean change|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.424|TWO_SIDED|95.0|-0.36|0.15||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.15|-0.36|0.424
71891462|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.219|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.169|0.268||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.268|0.169|<0.0001
71666944|NCT03449446|142849105|SUPERIORITY||Difference in percentages|3.7||||0.6219|TWO_SIDED|95.0|-10.9|18.3||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||18.3|-10.9|0.6219
71666945|NCT03449446|142849105|SUPERIORITY||Difference in percentages|8.8||||0.2554|TWO_SIDED|95.0|-6.4|24.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||24.1|-6.4|0.2554
71666946|NCT03449446|142849105|SUPERIORITY||Difference in percentages|10.8||||0.1658|TWO_SIDED|95.0|-4.5|26.1||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.1|-4.5|0.1658
71666947|NCT03449446|142849105|SUPERIORITY||Difference in percentages|3.2||||0.6963|TWO_SIDED|95.0|-12.9|19.4||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||19.4|-12.9|0.6963
71666948|NCT03449446|142849105|SUPERIORITY||Difference in percentages|10.0||||0.2441|TWO_SIDED|95.0|-6.8|26.8||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.8|-6.8|0.2441
71666949|NCT03449446|142849105|SUPERIORITY||Difference in percentages|5.2||||0.5229|TWO_SIDED|95.0|-10.7|21.0||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||21.0|-10.7|0.5229
71666950|NCT03449446|142849105|SUPERIORITY||Difference in percentages|10.4||||0.2149|TWO_SIDED|95.0|-6.0|26.9||The p-value between each pair of treatment groups presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|Mantel Haenszel||The percentage difference and 95% C.I. presented were obtained by the stratum-adjusted MH method, with baseline diabetes mellitus status and baseline cirrhosis status as stratification factors.|||26.9|-6.0|0.2149
71666951|NCT02448368|142849106|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio|232.0|||||TWO_SIDED|90.0|202.0|266.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||266|202|
71666952|NCT02448368|142849106|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|181.0|||||TWO_SIDED|90.0|164.0|200.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||200|164|
71666953|NCT02448368|142849106|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|106.0|||||TWO_SIDED|90.0|91.5|124.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||124|91.5|
71666954|NCT02448368|142849108|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|147.0|195.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||195|147|
71666955|NCT02448368|142849108|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||TWO_SIDED|90.0|146.0|199.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||199|146|
71666956|NCT02448368|142849108|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|129.0|||||TWO_SIDED|90.0|114.0|146.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||146|114|
71666957|NCT02448368|142849109|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|161.0|||||TWO_SIDED|90.0|139.0|187.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||187|139|
71748467|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0614|TWO_SIDED|95.0|-0.83|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.08|-0.83|0.0614
71748468|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.92|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.18|-0.92|0.0040
71748469|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.33|-0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.58|-1.33|<0.0001
71748470|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.47|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.47|<0.0001
71748471|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0967|TWO_SIDED|95.0|-0.7|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.06|-0.70|0.0967
71748472|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.15|-0.90|0.0063
71748473|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.13|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.38|-1.13|<0.0001
71748474|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0632|TWO_SIDED|95.0|-0.75|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.02|-0.75|0.0632
71666958|NCT02448368|142849109|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|159.0|||||TWO_SIDED|90.0|135.0|188.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||188|135|
71748475|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.0|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.23|-1.00|0.0020
71748476|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.29|-0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.51|-1.29|<0.0001
71748477|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.48|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.69|-1.48|<0.0001
71748478|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0308|TWO_SIDED|95.0|-0.82|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.04|-0.82|0.0308
71748479|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0105|TWO_SIDED|95.0|-0.89|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.12|-0.89|0.0105
71748480|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.03|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.26|-1.03|0.0010
71748481|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1469|TWO_SIDED|95.0|-0.69|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.69|0.1469
71666959|NCT02448368|142849109|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|131.0|||||TWO_SIDED|90.0|116.0|147.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||147|116|
71666960|NCT02448368|142849111|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.4|||||TWO_SIDED|90.0|88.3|112.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||112|88.3|
71666961|NCT02448368|142849111|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.9|||||TWO_SIDED|90.0|85.5|117.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||117|85.5|
71666962|NCT02448368|142849111|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|116.0|||||TWO_SIDED|90.0|94.8|143.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||143|94.8|
71666963|NCT02448368|142849112|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.3|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.3|
71666964|NCT02448368|142849112|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|104.0|||||TWO_SIDED|90.0|95.0|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|95.0|
71666965|NCT02448368|142849112|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|115.0|||||TWO_SIDED|90.0|95.3|140.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||140|95.3|
71666966|NCT02448368|142849113|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|107.0|||||TWO_SIDED|90.0|98.1|116.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||116|98.1|
71666967|NCT02448368|142849113|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|103.0|||||TWO_SIDED|90.0|94.6|113.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||113|94.6|
71666968|NCT02448368|142849113|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|113.0|||||TWO_SIDED|90.0|93.3|137.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||137|93.3|
71666969|NCT04460885|142849121|NON_INFERIORITY|The response and change from baseline in response after 52 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and region as fixed factors, and baseline response as covariate.|Treatment difference|-0.19|||<|0.0001|TWO_SIDED|95.0|-0.36|-0.03|||ANCOVA|||||-0.03|-0.36|<0.0001
71666970|NCT03956355|142849184|SUPERIORITY||Risk Ratio (RR)|5.78|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71666971|NCT03956355|142849185|SUPERIORITY||Risk Ratio (RR)|2.76|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71666972|NCT03956355|142849186|SUPERIORITY||Risk Ratio (RR)|2.68||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0001
71666973|NCT03956355|142849187|SUPERIORITY||Least squares mean difference|-3.28|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71666974|NCT03956355|142849188|SUPERIORITY||Risk Ratio (RR)|8.54||||0.0005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0005
71666975|NCT00733005|142849277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0|||||ANCOVA|||||||0.102
71666976|NCT00733005|142849278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019||95.0|||||ANCOVA|||||||0.019
71666977|NCT00266630|142849279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||||TWO_SIDED|95.0|-4.1|-1.9||||||||-1.90|-4.10|
71666978|NCT00266630|142849283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8|||||TWO_SIDED|95.0|-25.58|-14.06||||||||-14.06|-25.58|
71666979|NCT02548156|142849551|SUPERIORITY_OR_OTHER||Ratio of LS mean|1.52|||<|0.0001|TWO_SIDED|95.0||||From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.|ANCOVA||Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio \>1 favors the first named treatment.|Test and Reference dentifrice combined vs. Comparator dentifrice||||<0.0001
71666980|NCT01068262|142849555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.2|||||TWO_SIDED|90.0|50.9|80.2|||Linear mixed effect model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||80.2|50.9|
71666981|NCT01068262|142849555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-14.7|14.9|||Linear mixed effects model|Back-transformed least squares estimates and confidence intervals from a linear mixed effect model were performed on natural log-transformed values.||||14.9|-14.7|
71666982|NCT01068262|142849556|SUPERIORITY_OR_OTHER||Estimate|0.9|||||TWO_SIDED|90.0|0.75|1.07||Hypothesis: Following 4 weeks of Qw oral dosing of Odanacatib 50 mg, there is no clinically important difference in the true GMR (male/postmenopausal female) of the AUC0-168hr. The GMR is contained within the interval (0.4, 2.0).|Geometric Mean Ratio (GMR); male/female|||||1.07|0.75|
71666983|NCT01068262|142849557|SUPERIORITY_OR_OTHER||GMR|0.93|||||TWO_SIDED|90.0|0.82|1.04|||GMR|||||1.04|0.82|
71666984|NCT01068262|142849558|SUPERIORITY_OR_OTHER||Estimate|0.95|||||TWO_SIDED|90.0|0.66|1.35|||GMR|||||1.35|0.66|
71666985|NCT01153425|142849590|OTHER|unpaired t-test for the difference of the means between the two arms|||||>|0.05|||||||t-test, 2 sided|||paired t-test for change from baseline to 24 months||||>0.05
71666986|NCT01232452|142849600|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.848|TWO_SIDED|95.0|0.73|1.47|||Log Rank|||||1.47|0.73|0.848
71666987|NCT01232452|142849601|SUPERIORITY|||||||0.338|||||||Fisher Exact|||||||0.338
71666988|NCT05024747|142849612|OTHER||Ratio T/R|96.68|||||TWO_SIDED|90.0|90.0|103.85||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||103.85|90.00|
71666989|NCT05024747|142849613|OTHER||Ratio T/R|92.37|||||TWO_SIDED|90.0|85.45|99.84||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||99.84|85.45|
71666990|NCT05024747|142849614|OTHER||Ratio T/R|92.54|||||TWO_SIDED|90.0|85.63|100.01||||||Statistical comparison was analyzed between Test vs Reference based on Baseline Adjusted Data.||100.01|85.63|
71666991|NCT05024747|142849615|OTHER||Hodges- Lehmann's median difference|-0.0192||||0.0833|TWO_SIDED|95.0|-0.0542|0.0044|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0044|-0.0542|0.0833
71666992|NCT05024747|142849616|OTHER||Hodges- Lehmann's median difference|-6.0||||0.0205|TWO_SIDED|95.0|-10.5|0.0|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.0000|-10.5000|0.0205
71666993|NCT05024747|142849617|OTHER||Hodges- Lehmann's median difference|0.3225||||0.0946|TWO_SIDED|95.0|-0.0949|0.681|||Wilcoxon Signed Rank Test|||Statistical comparison was analyzed between Test vs Reference.||0.6810|-0.0949|0.0946
71666994|NCT05274178|142849637|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
71666995|NCT05274178|142849637|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>.05
71666996|NCT01965860|142849694|SUPERIORITY|||||||0.001|||||||ANOVA|||"Prior to the study a power analysis was performed to calculate the number of participants required in each of the three groups. Previous work comparing OSATS derived scores in endovascular interventions shows a Cohen D of two. Using a of .05, a power of .80, and an expected dropout rate of 10%, the minimum number of surgical trainees required per group was seven.~Null hypothesis for primary outcome: no difference in technical performance during real life procedures between the three groups"||||0.001
71666997|NCT01965860|142849694|OTHER|||||||0.003|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.003
71666998|NCT01965860|142849694|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.001
71666999|NCT01965860|142849694|OTHER|||||||0.228|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test MCQ score||||0.228
71667000|NCT01965860|142849694|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.001
71667001|NCT01965860|142849694|OTHER|||||||0.008|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.008
71667002|NCT01965860|142849694|OTHER|||||||0.164|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test GRS score||||0.164
71667003|NCT01965860|142849694|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
71667004|NCT01965860|142849694|OTHER|||||||0.001|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.001
71667005|NCT01965860|142849694|OTHER|||||||0.19|||||||ANOVA|||Null Hypothesis: There is no difference in Pre and Post test Examiner's checklist score||||0.190
71667006|NCT02288325|142849700|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0212|TWO_SIDED|95.0|0.33|0.92|||Log Rank|||||0.92|0.33|0.0212
71667007|NCT03735121|142849703|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% confidence interval \[CI\] of the geometric mean ratio is greater than or equal to (≥) the non-inferiority margin 0.8.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.88|1.24||||||||1.24|0.88|
71667008|NCT03735121|142849704|NON_INFERIORITY|The null hypothesis that atezolizumab SC is inferior to atezolizumab IV is rejected if the lower bound of the 2-sided 90% CI of the geometric mean ratio is ≥ the non-inferiority margin 0.8.|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.83|0.92||||||||0.92|0.83|
71667009|NCT03076775|142849763|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71667010|NCT03076775|142849764|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71667011|NCT03076775|142849765|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71667012|NCT03076775|142849766|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71667013|NCT03076775|142849767|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71667014|NCT03076775|142849768|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71667015|NCT03076775|142849769|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71667016|NCT03076775|142849770|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71667017|NCT03076775|142849771|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71667018|NCT03076775|142849772|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
71667019|NCT02890355|142849807|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.28|TWO_SIDED|95.0|0.85|1.78||a priori threshold for statistical significance, one sided p=0.02|Log Rank|||||1.78|0.85|0.28
71667020|NCT02890355|142849809|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.09|TWO_SIDED|95.0|0.96|2.02|||Log Rank|||||2.02|0.96|0.09
71667021|NCT01128179|142849816|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1121||||0.3186|TWO_SIDED|95.0|-0.3389|0.1146||The a priori significance level was 5%. There was no adjustment for multiple comparisons.|ANCOVA|||Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.||0.1146|-0.3389|0.3186
71891463|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.143|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.193|0.094|<0.0001
71748482|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0315|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.04|-0.84|0.0315
71748483|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.18|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.38|-1.18|0.0002
71748484|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.43|-1.26|<0.0001
71748485|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4494|TWO_SIDED|95.0|-0.56|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.25|-0.56|0.4494
71748486|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0595|TWO_SIDED|95.0|-0.79|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.02|-0.79|0.0595
71748487|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0065|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-0.96|0.0065
71748488|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.77|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.04|-0.77|0.0745
71891464|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.209|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.16|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.160|<0.0001
71891465|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.104|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.104|<0.0001
71891466|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.134|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.183||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.183|0.084|<0.0001
71748489|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.054|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.01|-0.80|0.0540
71748490|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0001|TWO_SIDED|95.0|-1.22|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.41|-1.22|0.0001
71748491|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.26|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.43|-1.26|<0.0001
71748492|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.5317|TWO_SIDED|95.0|-0.54|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.54|0.5317
71780798|NCT01817530|143061427|SUPERIORITY||difference in LS mean change|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.528|TWO_SIDED|95.0|-0.18|0.35||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||||0.35|-0.18|0.528
71891467|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.025||0.6974|TWO_SIDED|95.0|-0.04|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.059|-0.040|0.6974
71667022|NCT01128179|142849817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.54||||0.2995|TWO_SIDED|95.0|-6.15|19.23||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate. The study was not powered for the analysis of this parameter.||19.23|-6.15|0.2995
71667023|NCT01128179|142849818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.3252|TWO_SIDED|95.0|-5.36|15.57||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate. The study was not powered for the analysis of this parameter.||15.57|-5.36|0.3252
71667024|NCT01128179|142849819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1459|TWO_SIDED|95.0|-8.845|1.403||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate. The study was not powered for the analysis of this parameter.||1.403|-8.845|0.1459
71667025|NCT01128179|142849820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0297||||0.6134|TWO_SIDED|95.0|-0.1492|0.0897||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate. The study was not powered for the analysis of this parameter||0.0897|-0.1492|0.6134
71667026|NCT01128179|142849821|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0294||||0.5636|TWO_SIDED|95.0|-0.0739|0.1328||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate. The study was not powered for the analysis of this parameter.||0.1328|-0.0739|0.5636
71667027|NCT01128179|142849822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.0129||||0.922|TWO_SIDED|95.0|-0.2811|0.2553||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.||0.2553|-0.2811|0.9220
71667028|NCT00720382|142849824|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Overall baseline score||||0.783
71667029|NCT00720382|142849824|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 1||||0.971
71667030|NCT00720382|142849824|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED|95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 3||||0.206
71667031|NCT00720382|142849824|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 6||||0.111
71667032|NCT00720382|142849824|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 9||||0.181
71667033|NCT00720382|142849824|SUPERIORITY_OR_OTHER|||||||0.037|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from Baseline to Month 12/Early Term||||0.037
71667034|NCT01995513|142849839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.828||||0.2176|TWO_SIDED|95.0|0.612|1.119||P-value was based on log-rank test stratified by PSA response (greater than or equal to \[\>=\] 0 percent \[%\] to less than \[\<\] 30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.119|0.612|0.2176
71667035|NCT01995513|142849840|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.874||||0.45|TWO_SIDED|95.0|0.617|1.239||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.239|0.617|0.4500
71667036|NCT01995513|142849841|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.65||||0.3101|TWO_SIDED|95.0|-4.82|1.51||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=50% decrease from baseline in PSA response.||1.51|-4.82|0.3101
71667037|NCT01995513|142849841|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-0.04||||0.9917|TWO_SIDED|95.0|-3.9|3.82||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with \>=30% decrease from baseline in PSA response.||3.82|-3.90|0.9917
71667038|NCT01995513|142849842|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|-5.0||||0.1653|TWO_SIDED|95.0|-11.75|1.75||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR.||1.75|-11.75|0.1653
71748493|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0424|TWO_SIDED|95.0|-0.83|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.01|-0.83|0.0424
71748494|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0134|TWO_SIDED|95.0|-0.91|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.11|-0.91|0.0134
71748495|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0300
71748496|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0605|TWO_SIDED|95.0|-0.78|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||0.02|-0.78|0.0605
71748497|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|-1.2|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.40|-1.20|0.0001
71748498|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.56|-1.38|<0.0001
71667039|NCT01995513|142849842|SUPERIORITY_OR_OTHER_LEGACY||Difference in Objective Response Rate|10.92||||0.3216|TWO_SIDED|95.0|-10.37|32.21||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR+SD.||32.21|-10.37|0.3216
71667040|NCT01995513|142849843|SUPERIORITY_OR_OTHER_LEGACY||Difference in Progression Rate|9.09||||0.2963|TWO_SIDED|95.0|-7.69|25.87||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in Progression Rate was based upon normal approximation.|||25.87|-7.69|0.2963
71667041|NCT01995513|142849844|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.861||||0.3818|TWO_SIDED|95.0|0.616|1.204||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||1.204|0.616|0.3818
71667042|NCT01995513|142849851|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.399||||0.0739|TWO_SIDED|95.0|0.967|2.025||P-value was based on log-rank test stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (\>=0% to \<30% vs \>=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with \< 1 favoring Enzalutamide.|||2.025|0.967|0.0739
71667043|NCT00247676|142849891|SUPERIORITY_OR_OTHER||clinical benefit response rate|37.8||||||95.0|22.5|55.2|||||Clinical benefit response rate: percent of patients with confirmed CR, confirmed PR, or SD for at least 12 weeks according to RECIST, relative to total treated patients.|||55.2|22.5|
71748499|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1848|TWO_SIDED|95.0|-0.68|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.13|-0.68|0.1848
71748500|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0321|TWO_SIDED|95.0|-0.84|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.04|-0.84|0.0321
71748501|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0025|TWO_SIDED|95.0|-1.01|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.22|-1.01|0.0025
71748502|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0441|TWO_SIDED|95.0|-0.81|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.81|0.0441
71748503|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0422|TWO_SIDED|95.0|-0.82|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.01|-0.82|0.0422
71748504|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.45|-1.27|<0.0001
71835113|NCT01631214|143174834|SUPERIORITY|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|2.9|3.54|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.54|2.90|<0.001
71667044|NCT00247676|142849896|SUPERIORITY_OR_OTHER||objective response rate|2.7||||||95.0|0.1|14.2|||||percentage of patients with confirmed CR or confirmed PR according to RECIST, relative to the total number of treated patients.|||14.2|0.1|
71667045|NCT00247676|142849900|SUPERIORITY_OR_OTHER||probability|0.324||||||95.0|0.168|0.479|||||probability derived from Kaplan-Meier estimate.|||0.479|0.168|
71667046|NCT01750190|142849918|SUPERIORITY||Least Square Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|1.735|1.967|||ANCOVA|MI (Multiple Imputation) ANCOVA|Roxadustat - Placebo Treatment Difference|Treatment comparison was made using the multiple imputation strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb and baseline estimated glomerular filtration rate (eGFR) as covariates and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 milliliters \[mL\]/minutes \[min\]/1.73 meters \[m\]\^2), as fixed effects.||1.967|1.735|<0.0001
71667047|NCT01750190|142849919|SUPERIORITY||Odds Ratio (OR)|77.56|||<|0.0001|TWO_SIDED|95.0|44.73|134.48|||Cochran-Mantel-Haenszel||Roxadustat/Placebo Odds ratio|||134.48|44.73|<0.0001
71667048|NCT01750190|142849920|SUPERIORITY||Least Square Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|1.73|2.037|||Mixed Models Analysis|MMRM Analysis|Roxadustat - placebo treatment difference|Treatment comparison was made using MMRM with baseline Hb and baseline eGFR as covariates, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2), as fixed effects.||2.037|1.730|<0.0001
71748505|NCT03192176|143005295|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.44|-0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.62|-1.44|<0.0001
71780799|NCT01817530|143061428|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.8|1.74||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.74|0.80|< 0.001
71780800|NCT01817530|143061428|SUPERIORITY||difference in LS means|1.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.78|1.72||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.72|0.78|< 0.001
71780801|NCT01817530|143061428|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|0.33|1.27||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.27|0.33|< 0.001
71780802|NCT01817530|143061428|SUPERIORITY||difference in LS means|1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.65|1.52||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.52|0.65|< 0.001
71780803|NCT01817530|143061428|SUPERIORITY||difference in LS means|0.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.29|1.16||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.16|0.29|< 0.001
71780804|NCT01817530|143061428|SUPERIORITY||difference in LS means|0.8|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.4|1.26||P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.|ANCOVA|||||1.26|0.4|< 0.001
71780805|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780806|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780807|NCT01817530|143061429|SUPERIORITY|||||||0.018||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.018
71780808|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780809|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780810|NCT01817530|143061429|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.021
71780811|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71667049|NCT01750190|142849921|SUPERIORITY||Least Square Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|1.663|2.143|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb and baseline eGFR as covariates , and treatment and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73m\^2 ), as fixed effects.||2.143|1.663|<0.0001
71667050|NCT01750190|142849922|SUPERIORITY||Odds Ratio (OR)|15.47|||<|0.0001|TWO_SIDED|95.0|10.79|22.189|||Cochran-Mantel-Haenszel||Roxadustat/placebo odds ratio|||22.189|10.79|<0.0001
71667051|NCT01750190|142849923|SUPERIORITY||Least Square Mean Difference|-17.26|STANDARD_ERROR_OF_MEAN|1.73|<|0.0001|TWO_SIDED|95.0|-20.65|-13.87|||Mixed Models Analysis|MMRM Analysis|Roxadustat- placebo treatment difference|Treatment comparison was made using MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction, and the randomization stratification factors as fixed effects.||-13.87|-20.65|<0.0001
71667052|NCT01750190|142849924|SUPERIORITY||Least Square Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.528||0.6924|TWO_SIDED|95.0|-0.827|1.245|||ANCOVA|MI ANCOVA|Roxadustat - placebo treatment difference|||1.245|-0.827|0.6924
71667053|NCT01750190|142849925|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.165|0.406||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||||0.406|0.165|<0.0001
71667054|NCT01750190|142849926|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.108|0.267||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and the randomization stratification factors, except baseline Hb (\<=8 g/dL versus \>8 g/dL) and eGFR (\<30 versus \>=30 mL/min/1.73m\^2).|Cox Proportional hazards model|||First 24 Weeks of Treatment||0.267|0.108|<0.0001
71835114|NCT01631214|143174835|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.84|7.89|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||7.89|6.84|<0.001
71835115|NCT01631214|143174836|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.29|4.02|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||4.02|3.29|<0.001
71835116|NCT01631214|143174837|SUPERIORITY|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|3.18|3.97|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.||3.97|3.18|<0.001
71835117|NCT03857620|143174854|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.53|TWO_SIDED|95.0|-0.85|0.45|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||0.45|-0.85|0.53
71835118|NCT03857620|143174854|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.84|TWO_SIDED|95.0|-0.67|0.81|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.81|-0.67|0.84
71667055|NCT01750190|142849926|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.138|0.276||From a Cox Proportional hazards model adjusting for baseline Hb, baseline eGFR and other randomization stratification factors, except baseline Hb (≤8 g/dL versus \>8 g/dL) and eGFR (\<30 versus ≥30 mL/min/1.73 m\^2).|Cox Proportional hazards model|||First 52 Weeks of Treatment||0.276|0.138|<0.0001
71667056|NCT04584684|142849930|SUPERIORITY|||||||0.89||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.89
71667057|NCT04584684|142849930|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.88
71667058|NCT04584684|142849930|SUPERIORITY|||||||0.82||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.82
71835119|NCT03857620|143174854|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.21|0.26|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||0.26|-1.21|0.19
71835120|NCT03857620|143174854|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.14|TWO_SIDED|95.0|-0.19|1.29|||Mixed Models Analysis|Generalized linear mixed effects model (w/ Gaussian link) w/ random practice effect to account for clustering by site \& bsl CHAMPS score as covariate||||1.29|-0.19|0.14
71667059|NCT04584684|142849930|SUPERIORITY|||||||0.65||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.65
71667060|NCT04584684|142849930|SUPERIORITY|||||||0.77||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.77
71667061|NCT04584684|142849930|SUPERIORITY|||||||0.76||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.76
71667062|NCT04584684|142849930|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
71667063|NCT04584684|142849930|SUPERIORITY|||||||0.71||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.71
71667064|NCT04584684|142849930|SUPERIORITY|||||||0.6||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.60
71667065|NCT04584684|142849930|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.80
71667066|NCT02955212|142849945|SUPERIORITY||Response Rate Difference|40.2|||<|0.001|TWO_SIDED|95.0|30.5|50.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||50.0|30.5|<0.001
71667067|NCT02955212|142849946|SUPERIORITY||Least Squares (LS) Mean Difference|-1.61|||<|0.001|TWO_SIDED|95.0|-1.86|-1.36|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-1.36|-1.86|<0.001
71667068|NCT02955212|142849947|SUPERIORITY||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.55|-0.33|||ANCOVA|ANCOVA model including treatment as the fixed factor, and Baseline value and the stratification factor country as the covariates.|LS Mean Difference = Upadacitinib - Placebo|||-0.33|-0.55|<0.001
71667069|NCT02955212|142849948|SUPERIORITY||LS Mean Difference|5.57|||<|0.001|TWO_SIDED|95.0|4.13|7.01|||Mixed Effect Model Repeat Measurement|MMRM model with treatment, visit, treatment-by-visit interaction and stratification factor of country as fixed effects and Baseline value as covariate|LS Mean Difference = Upadacitinib - Placebo|||7.01|4.13|<0.001
71667070|NCT02955212|142849949|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|23.4|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor country.|Response Rate Difference = Upadacitinib - Placebo|||41.7|23.4|<0.001
71667071|NCT02955212|142849950|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|24.3|16.6|31.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||31.9|16.6|<0.001
71667072|NCT02955212|142849951|SUPERIORITY||Response Rate Difference|24.3|||<|0.001|TWO_SIDED|95.0|15.6|32.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||32.9|15.6|<0.001
71667073|NCT02955212|142849952|SUPERIORITY||Response Rate Difference|32.5|||<|0.001|TWO_SIDED|95.0|24.0|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||41.0|24.0|<0.001
71667074|NCT02955212|142849953|SUPERIORITY||Response Rate Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.0|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country.|Response Rate Difference = Upadacitinib - Placebo|||24.5|11.0|<0.001
71667075|NCT02955212|142849954|SUPERIORITY||Response Rate Difference|19.5|||<|0.001|TWO_SIDED|95.0|12.1|27.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of country|Response Rate Difference = Upadacitinib - Placebo|||27.0|12.1|<0.001
71667076|NCT02664181|142849972|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Partial remission rate was compared between both arms. The null hypothesis is that there is no difference in partial remission rate between the two arms, with a p-value of \< 0.05 indicating significance||||0.05
71667077|NCT02664181|142849973|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.13|1.21|||Log Rank|||||1.21|0.13|0.06
71667078|NCT02664181|142849974|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.19|TWO_SIDED|95.0|0.11|1.62|||Log Rank||Data from Kaplan-Meier analyses|||1.62|0.11|0.19
71667079|NCT02556801|142849996|SUPERIORITY||Test statistic|1.823||||0.057|ONE_SIDED||||||MCP-Mod Method|The primary dose-response analysis was performed by applying linear, Emax, logistic and exponential models.The p-value was based on Emax model.||||||0.057
71667080|NCT02556801|142849996|SUPERIORITY||Treatment effect|-1.96|STANDARD_DEVIATION|1.17|||TWO_SIDED|90.0|-3.89|-0.03||||||||-0.03|-3.89|
71667081|NCT02556801|142849996|SUPERIORITY||Treatment effect|-1.83|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.72|0.06||||||||0.06|-3.72|
71667082|NCT02556801|142849996|SUPERIORITY||Treatment effect|-2.33|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-4.23|-0.43||||||||-0.43|-4.23|
71667083|NCT02556801|142849997|SUPERIORITY||Treatment effect|-1.92|STANDARD_ERROR_OF_MEAN|1.17|=|0.051|TWO_SIDED|90.0|-3.85|0.01|||Mixed Models Analysis|||||0.01|-3.85|=0.051
71667084|NCT02556801|142849997|SUPERIORITY||Treatment effect|-1.79|STANDARD_ERROR_OF_MEAN|1.14||0.059|TWO_SIDED|90.0|-3.68|0.1|||Mixed Models Analysis|||||0.10|-3.68|0.059
71667085|NCT02556801|142849997|SUPERIORITY||Treatment effect|-2.3|STANDARD_ERROR_OF_MEAN|1.15||0.024|TWO_SIDED|90.0|-4.2|-0.4|||Mixed Models Analysis|||||-0.40|-4.20|0.024
71667086|NCT02556801|142849998|SUPERIORITY||Treatment effect|-0.6|STANDARD_ERROR_OF_MEAN|1.08||0.291|TWO_SIDED|90.0|-2.39|1.19|||Mixed Models Analysis|||||1.19|-2.39|0.291
71667087|NCT02556801|142849998|SUPERIORITY||Treatment effect|-1.84|STANDARD_ERROR_OF_MEAN|1.06|=|0.042|TWO_SIDED|90.0|-3.6|-0.09|||Mixed Models Analysis|||||-0.09|-3.60|=0.042
71667088|NCT02556801|142849998|SUPERIORITY||Treatment effect|-1.78|STANDARD_ERROR_OF_MEAN|1.08||0.05|TWO_SIDED|90.0|-3.56|0.0|||Mixed Models Analysis|||||0.00|-3.56|0.050
71667089|NCT02556801|142849999|SUPERIORITY||Treatment effect|-0.89|STANDARD_ERROR_OF_MEAN|0.63|=|0.079|TWO_SIDED|90.0|-1.93|0.15|||Mixed Models Analysis|||||0.15|-1.93|=0.079
71667090|NCT02556801|142849999|SUPERIORITY||Treatment effect|-0.88|STANDARD_ERROR_OF_MEAN|0.61|=|0.076|TWO_SIDED|90.0|-1.89|0.13|||Mixed Models Analysis|||||0.13|-1.89|=0.076
71667091|NCT02556801|142849999|SUPERIORITY||Treatment effect|-1.11|STANDARD_ERROR_OF_MEAN|0.62|=|0.038|TWO_SIDED|0.62|-2.13|-0.08|||Mixed Models Analysis|||||-0.08|-2.13|=0.038
71667092|NCT02556801|142850000|SUPERIORITY||Treatment effect|-0.07|STANDARD_ERROR_OF_MEAN|0.58|=|0.451|TWO_SIDED|90.0|-1.03|0.88|||Mixed Models Analysis|||||0.88|-1.03|=0.451
71667093|NCT02556801|142850000|SUPERIORITY||Treatment effect|-0.62|STANDARD_ERROR_OF_MEAN|0.56|=|0.137|TWO_SIDED|90.0|-1.55|0.32|||Mixed Models Analysis|||||0.32|-1.55|=0.137
71667094|NCT02556801|142850000|SUPERIORITY||Treatment effect|-0.5|STANDARD_ERROR_OF_MEAN|0.57|=|0.195|TWO_SIDED|90.0|-1.45|0.46|||Mixed Models Analysis|||||0.46|-1.45|=0.195
71667095|NCT02556801|142850001|SUPERIORITY||Treatment effect|-0.354|STANDARD_ERROR_OF_MEAN|0.183|=|0.028|TWO_SIDED|90.0|-0.657|-0.05|||ANOVA|||||-0.050|-0.657|=0.028
71667096|NCT02556801|142850001|SUPERIORITY||Treatment effect|-0.394|STANDARD_ERROR_OF_MEAN|0.186|=|0.018|TWO_SIDED|90.0|-0.702|-0.086|||ANOVA|||||-0.086|-0.702|=0.018
71835121|NCT03857620|143174855|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.23|2.09|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||Combined Arm II (OPTI-Surg) \& Arm III (OPTI-Surg plus Coach) vs. Arm I (Usual Care)||2.09|0.23|0.50
71835122|NCT03857620|143174855|SUPERIORITY||Odds Ratio (OR)|0.46||||0.21|TWO_SIDED|95.0|0.13|1.62|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.62|0.13|0.21
71748506|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1464|TWO_SIDED|95.0|-0.71|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.11|-0.71|0.1464
71748507|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0144|TWO_SIDED|95.0|-0.91|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.10|-0.91|0.0144
71748508|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0013|TWO_SIDED|95.0|-1.06|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.26|-1.06|0.0013
71748509|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0596|TWO_SIDED|95.0|-0.8|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.02|-0.80|0.0596
71748510|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.036|TWO_SIDED|95.0|-0.85|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.03|-0.85|0.0360
71748511|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0006|TWO_SIDED|95.0|-1.15|-0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.32|-1.15|0.0006
71748512|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.21||0.0002|TWO_SIDED|95.0|-1.23|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.39|-1.23|0.0002
71748513|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3227|TWO_SIDED|95.0|-0.62|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.21|-0.62|0.3227
71835123|NCT03857620|143174855|SUPERIORITY||Odds Ratio (OR)|1.03||||0.96|TWO_SIDED|95.0|0.3|3.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||3.54|0.30|0.96
71835124|NCT03857620|143174855|SUPERIORITY||Odds Ratio (OR)|0.45||||0.19|TWO_SIDED|95.0|0.13|1.54|||Mixed Models Analysis|Generalized linear mixed effects model (with logit link function) with a random practice effect to account for clustering within practice||||1.54|0.13|0.19
71748514|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.89|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.07|-0.89|0.0220
71748515|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.038|TWO_SIDED|95.0|-0.84|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.02|-0.84|0.0380
71748516|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.6|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.10|-0.60|0.0067
71748517|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1227|TWO_SIDED|95.0|-0.45|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.05|-0.45|0.1227
71748518|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0208|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.05|-0.57|0.0208
71748519|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.2396|TWO_SIDED|95.0|-0.41|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.10|-0.41|0.2396
71748520|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0022|TWO_SIDED|95.0|-0.67|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.15|-0.67|0.0022
71835125|NCT05332340|143174885|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.683|TWO_SIDED||||||Kruskal-Wallis|||||||0.683
71667097|NCT02556801|142850001|SUPERIORITY||Treatment effect|-0.28|STANDARD_ERROR_OF_MEAN|0.182|=|0.063|TWO_SIDED|90.0|-0.581|0.021|||ANOVA|||||0.021|-0.581|=0.063
71667098|NCT02556801|142850002|SUPERIORITY||Treatment effect|1.92|||<|0.001|TWO_SIDED|90.0|1.41|2.6|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||2.60|1.41|<0.001
71667099|NCT02556801|142850002|SUPERIORITY||Treatment effect|2.43|||<|0.001|TWO_SIDED|90.0|1.8|3.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.27|1.80|<0.001
71667100|NCT02556801|142850002|SUPERIORITY||Treatment effect|2.34|||<|0.001|TWO_SIDED|90.0|1.73|3.15|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)||3.15|1.73|<0.001
71667101|NCT02556801|142850002|SUPERIORITY||Treatment effect|1.42||||0.029|TWO_SIDED|90.0|1.05|1.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.93|1.05|0.029
71667102|NCT02556801|142850002|SUPERIORITY||Treatment effect|1.67||||0.003|TWO_SIDED|90.0|1.24|2.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||2.25|1.24|0.003
71667103|NCT02556801|142850002|SUPERIORITY||Treatment effect|1.37||||0.042|TWO_SIDED|90.0|1.01|1.85|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)||1.85|1.01|0.042
71667104|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.11||||0.057|TWO_SIDED|90.0|1.0|1.23|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.23|1.00|0.057
71667105|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.29|||<|0.001|TWO_SIDED|90.0|1.17|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.43|1.17|<0.001
71667106|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.24|||<|0.001|TWO_SIDED|90.0|1.12|1.37|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)||1.37|1.12|<0.001
71845289|NCT05886777|143204402|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 will be evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT:H0: ln(μ2)- ln(μ3) \<= ln(0.5)where ln(0.5) corresponds to a 2-fold margin for noninferiority and ln(μ2) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 6,3, respectively.|Geometric mean ratio|0.97|||||TWO_SIDED|97.5|0.74|1.281|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.281|0.740|
71667107|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.23||||0.015|TWO_SIDED|90.0|1.05|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.45|1.05|0.015
71667108|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.6|||<|0.001|TWO_SIDED|90.0|1.37|1.87|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.87|1.37|<0.001
71667109|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.39|||<|0.001|TWO_SIDED|90.0|1.19|1.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)||1.62|1.19|<0.001
71667110|NCT02556801|142850003|SUPERIORITY||Treatment effect|0.99||||0.341|TWO_SIDED|90.0|0.93|1.04|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.04|0.93|0.341
71667111|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.1||||0.003|TWO_SIDED|90.0|1.04|1.16|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.16|1.04|0.003
71667112|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.02||||0.269|TWO_SIDED|90.0|0.97|1.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)||1.08|0.97|0.269
71667113|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.02||||0.312|TWO_SIDED|90.0|0.95|1.1|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.10|0.95|0.312
71667114|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.22|||<|0.001|TWO_SIDED|90.0|1.13|1.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.31|1.13|<0.001
71667115|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.11||||0.008|TWO_SIDED|90.0|1.03|1.2|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)||1.20|1.03|0.008
71667116|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.04||||0.212|TWO_SIDED|90.0|0.96|1.14|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.14|0.96|0.212
71667117|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.16||||0.002|TWO_SIDED|90.0|1.07|1.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.27|1.07|0.002
71667118|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.15||||0.004|TWO_SIDED|90.0|1.06|1.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)||1.25|1.06|0.004
71667119|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.09||||0.126|TWO_SIDED|90.0|0.96|1.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.24|0.96|0.126
71667120|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.28|||<|0.001|TWO_SIDED|90.0|1.13|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.45|1.13|<0.001
71667121|NCT02556801|142850003|SUPERIORITY||Treatment effect|1.26||||0.002|TWO_SIDED|90.0|1.11|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)||1.43|1.11|0.002
71667122|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.33||||0.032|TWO_SIDED|90.0|1.03|1.7|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||1.70|1.03|0.032
71667123|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.15|||<|0.001|TWO_SIDED|90.0|1.68|2.74|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.74|1.68|<0.001
71748521|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0479|TWO_SIDED|95.0|-0.53|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.53|0.0479
71667124|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.03|||<|0.001|TWO_SIDED|90.0|1.59|2.59|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)||2.59|1.59|<0.001
71667125|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.48||||0.024|TWO_SIDED|90.0|1.07|2.06|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.06|1.07|0.024
71667126|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|2.09|3.98|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||3.98|2.09|<0.001
71667127|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.12|||<|0.001|TWO_SIDED|90.0|1.54|2.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)||2.93|1.54|<0.001
71667128|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.18||||0.102|TWO_SIDED|90.0|0.95|1.47|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.47|0.95|0.102
71667129|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.99|||<|0.001|TWO_SIDED|90.0|1.61|2.46|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||2.46|1.61|<0.001
71667130|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.57|||<|0.001|TWO_SIDED|90.0|1.27|1.94|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)||1.94|1.27|<0.001
71748522|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4152|TWO_SIDED|95.0|-0.35|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.15|-0.35|0.4152
71780812|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780813|NCT01817530|143061429|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.032
71667131|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.39||||0.019|TWO_SIDED|90.0|1.07|1.81|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||1.81|1.07|0.019
71835126|NCT03137771|143174898|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.66|TWO_SIDED|95.0|0.68|1.4|||Log Rank|Two-sided test|Reference level = systemic therapy. Cox proportional hazards model stratified by histology (non-squamous vs squamous) and systemic therapy (immunotherapy-based regimens vs chemotherapy- only regimens).|Based on expected 6- and 12-month PFS rates of approximately 60% and 39% for the standard arm, assuming approximately exponential distributions, at least 138 PFS events are needed to detect a hazard ratio of 0.6 (a hazard reduction of 40%) with 95% power and a one-sided significance level of 0.15. The Cox proportional hazards model is stratified by histology and systemic therapy type. The hazard ratio estimate must be ≤ 0.83 for the study to proceed to the phase III component.||1.40|0.68|0.66
71667132|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.38|||<|0.001|TWO_SIDED|90.0|1.84|3.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||3.08|1.84|<0.001
71835127|NCT02488863|143174923|OTHER|ANOVA||||||0.0561|||||||ANOVA|||H0: mean(SPPB\_older\_pain) = mean(SPPB\_older\_no pain) = mean(SPPB\_younger)||||0.0561
71667133|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.7|||<|0.001|TWO_SIDED|90.0|1.31|2.19|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)||2.19|1.31|<0.001
71667134|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.52||||0.048|TWO_SIDED|90.0|1.01|2.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||2.31|1.01|0.048
71667135|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.35|||<|0.001|TWO_SIDED|90.0|1.56|3.53|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||3.53|1.56|<0.001
71667136|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.83|||<|0.001|TWO_SIDED|90.0|1.88|4.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)||4.24|1.88|<0.001
71667137|NCT02556801|142850004|SUPERIORITY||Treatment effect|1.67||||0.04|TWO_SIDED|90.0|1.03|2.69|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||2.69|1.03|0.040
71667138|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.68|||<|0.001|TWO_SIDED|90.0|1.67|4.3|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.30|1.67|<0.001
71667139|NCT02556801|142850004|SUPERIORITY||Treatment effect|2.88|||<|0.001|TWO_SIDED|90.0|1.8|4.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)||4.62|1.80|<0.001
71667140|NCT03668808|142850007|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-140mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
71780814|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780815|NCT01817530|143061429|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.007
71667141|NCT03668808|142850008|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||Null hypothesis is there was no difference in Time in Range (70-180mg/dl) in the initial 24 hours at destination, whether after Eastward travel or Westward travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance set at 0.05; using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
71667142|NCT03668808|142850009|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in Mean ± SD CGM glucose (mg/dl) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71667143|NCT03668808|142850010|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \<70 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71667144|NCT03668808|142850011|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time 70-180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71667145|NCT03668808|142850012|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in CGM % time \>180 mg/dl in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71667146|NCT03668808|142850013|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM - Coefficient of Variation (CV) in flight, East or West travel, and in 72 hours at destination, whether after East or West travel, between Insulin Degludec \& Insulin Glargine U100. Travel direction not tested. Criterion for significance was at 0.05. Using paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the SD of the difference is \<106 minutes.||||<0.05
71667147|NCT03668808|142850014|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is there was no difference in CGM Fasting Blood Glucose (FBG) at 0600 local time at destination, whether after East or West travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. Criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins assuming the standard deviation of the difference is \<106 minutes.||||<0.05
71667148|NCT03668808|142850015|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||Null hypothesis is that there was no difference in Liverpool Jet-Lag Questionnaire after 24 and 48 hours at the destination, whether after Eastward travel or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.01
71667149|NCT03668808|142850016|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in Sleep quantity measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
71667150|NCT03668808|142850017|SUPERIORITY||||||<|0.05||||||The tests were performed with a significance level of 0.05 (two-sided).|Wilcoxon (Mann-Whitney)|||Null hypothesis is there was no difference in Sleep efficiency measured by ActiGraph in 24 hours at the destination, whether after Eastward or after Westward travel, between Insulin Degludec and Insulin Glargine U100. Travel direction not tested. The criterion for significance was set at 0.05, and using a paired t-test analysis, a sample size of 21 subjects would achieve a power of at least 77% to detect a difference of 10% between basal insulins.||||<0.05
71667151|NCT02839772|142850020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.581|STANDARD_ERROR_OF_MEAN|0.296|<|0.001|TWO_SIDED|95.0|0.997|2.164|||Mixed Models Analysis|t=5.341, df=89.347||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions."||2.164|0.997|<0.001
71748523|NCT03192176|143005295|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0262|TWO_SIDED|95.0|-0.52|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.03|-0.52|0.0262
71891468|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.163|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.114|0.213||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.213|0.114|<0.0001
71891469|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0027|TWO_SIDED|95.0|0.026|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.125|0.026|0.0027
71667152|NCT02839772|142850021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.684|STANDARD_ERROR_OF_MEAN|0.346|<|0.001|TWO_SIDED|95.0|1.002|2.367|||Mixed Models Analysis|t=4.871, df=189.789||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||2.367|1.002|<0.001
71667153|NCT02839772|142850022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.386|<|0.001|TWO_SIDED|95.0|1.21|2.731|||Mixed Models Analysis|t=5.111, df=189.620||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions."||2.731|1.210|<0.001
71667154|NCT02839772|142850023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.751|STANDARD_ERROR_OF_MEAN|0.39||0.002|TWO_SIDED|95.0|0.656|2.846|||Mixed Models Analysis|t=3.154, df=189.580||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions."||2.846|0.656|0.002
71667155|NCT02839772|142850024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075|STANDARD_ERROR_OF_MEAN|0.515|<|0.001|TWO_SIDED|95.0|-3.042|-1.1078|||Mixed Models Analysis|t=-4.236,df=165.310||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions."||-1.1078|-3.042|<0.001
71667156|NCT02839772|142850025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.658|STANDARD_ERROR_OF_MEAN|0.467|<|0.001|TWO_SIDED|95.0|-2.581|-0.736|||Mixed Models Analysis|t=-3.549, df=180.923||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."||-0.736|-2.581|<0.001
71667157|NCT02839772|142850026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.641|STANDARD_ERROR_OF_MEAN|0.473||0.001|TWO_SIDED|95.0|-2.574|-0.708|||Mixed Models Analysis|t=-3.471, df=186.308||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions."||-0.708|-2.574|0.001
71667158|NCT02839772|142850027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.041|STANDARD_ERROR_OF_MEAN|0.572|<|0.001|TWO_SIDED|95.0|-3.168|-0.911|||Mixed Models Analysis|t=-3.565, df=186.739||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions."||-0.911|-3.168|<0.001
71667159|NCT02839772|142850028|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.452|STANDARD_ERROR_OF_MEAN|0.255||0.076|TWO_SIDED|95.0|-0.048|0.952||A cumulative logistic link function was used|Generalized estimating equation analysis|Wald Chi squared=3.138, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit."||0.952|-0.048|0.076
71780816|NCT01817530|143061429|SUPERIORITY|||||||0.495||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.495
71780817|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780818|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780819|NCT01817530|143061429|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.015
71667160|NCT02839772|142850029|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.224||||0.527|TWO_SIDED|95.0|-0.469|0.917||A Bernouilli distribution with a logistic link function was used.|Generalized estimating equation analysis|Wald chi-square=0.410, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit."||0.917|-0.469|0.527
71667161|NCT02839772|142850030|SUPERIORITY_OR_OTHER||Odds Ratio, log|-1.29|STANDARD_ERROR_OF_MEAN|0.446||0.031|TWO_SIDED|95.0|-2.161|-0.411||A Bernouilli distribution with a logistic link function was used|Generalized estimating equation analysis|Wald chi-square=8.304, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life."||-0.411|-2.161|0.031
71667162|NCT02839772|142850031|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.062|STANDARD_ERROR_OF_MEAN|0.741||0.005|TWO_SIDED|95.0|0.61|3.514||A Poisson distribution with a logarithmic link function was used|Generalized estimating equation analysis|Wald chi-square=7.745, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit."||3.514|0.610|0.005
71667163|NCT02839772|142850032|SUPERIORITY_OR_OTHER||Group ratio estimate|2.09|STANDARD_ERROR_OF_MEAN|1.102||0.058|TWO_SIDED|0.058|-0.069|4.25||A Poisson distribution with a logarithmic link function was used.|Generalized estimation equation|df=1|Those in the experimental group were expected to have fewer work days lost due to ADL.|"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL."||4.250|-0.069|0.058
71667164|NCT02839772|142850033|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value was \< 0.001 at all time points.|Spearman's correlation coefficient|The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.||The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.||||<0.001
71667165|NCT02839772|142850034|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.204||0.158|TWO_SIDED|95.0|-0.113|0.69|||Mixed Models Analysis|df=185.386||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease."||0.690|-0.113|0.158
71667166|NCT02839772|142850035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|STANDARD_ERROR_OF_MEAN|0.162|<|0.001|TWO_SIDED|95.0|0.255|0.895|||Mixed Models Analysis|df=169.916, t=3.550||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease."||0.895|0.255|<0.001
71667167|NCT02839772|142850036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.54||0.907|TWO_SIDED|95.0|-1.129|1.002|||Mixed Models Analysis|t=-0.117, df=178.814||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation.."||1.002|-1.129|0.907
71667168|NCT01895777|142850042|NON_INFERIORITY|Non-inferiority margin of 20%|Difference in Rates|-0.038|||=|0.0001|TWO_SIDED|90.0|-0.141|0.066||p-value for non-inferiority is actually \<0.0001|Cochran-Mantel-Haenszel||Difference in rates (SOC - DE)|The primary analysis of the primary efficacy endpoint used the randomised set, following the intention-to-treat principle, based on adjudication-confirmed data. Age group was used as stratification factor using a Mantel-Haenszel type weighted average of differences.||0.066|-0.141|= 0.0001
71667169|NCT01895777|142850043|OTHER||Kaplan-Meier estimate|0.0|||||TWO_SIDED|90.0|-0.032|0.032|||Kaplan-Meier estimate||Kaplan-Meier estimate of rate difference.|Time-to event endpoint using Kaplan-Meier estimates based on adjudication-confirmed data. Due to the low event rate of major bleeding, age group stratification was not considered.||0.032|-0.032|
71667170|NCT01895777|142850049|OTHER||Hazard Ratio (HR)|1.145|||||TWO_SIDED|90.0|0.736|1.78||||||Any bleeding events was analysed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model and age group as the stratification factor. A pooling of age groups was performed as no events were observed in certain age group.||1.780|0.736|
71667171|NCT01895777|142850050|OTHER||Hazard Ratio (HR)|69990000.0||||0.9976|TWO_SIDED|90.0|0.0|999999999.0|||Cox proportional hazard model||Upper Limit of the 90% confidence interval was not assessable|All-cause mortality was analyzed as time-to-event endpoint using a stratified Cox proportional hazard model with treatment as a covariate in the model.||999999999|0.000|0.9976
71667172|NCT04542057|142850066|SUPERIORITY||LS mean difference|0.0941|STANDARD_ERROR_OF_MEAN|0.01501|<|0.0001|TWO_SIDED|95.0|0.0647|0.1236||The analysis of covariance (ANCOVA) model was used to model the change from baseline FEV1 to average FEV1 AUC0-12h with treatment, region, background medication strata and smoking strata as fixed effects and baseline FEV1 as covariate.|ANCOVA|||||0.1236|0.0647|<0.0001
71667173|NCT01277211|142850097|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Pearl Indices|0.61||||0.531|TWO_SIDED|95.0|0.19|2.29|||Poisson distribution method|Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.||Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.||2.29|0.19|0.531
71667174|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-3.0||||0.346|TWO_SIDED|95.0|-9.9|3.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||3.1|-9.9|0.346
71667175|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-6.2||||0.029|TWO_SIDED|95.0|-12.7|-0.6|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-12.7|0.029
71667176|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-5.8||||0.019|TWO_SIDED|95.0|-11.8|-0.9|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.9|-11.8|0.019
71667177|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-8.0||||0.001|TWO_SIDED|95.0|-14.0|-2.9|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.9|-14.0|0.001
71667178|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.3||||0.556|TWO_SIDED|95.0|-6.4|2.6|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.6|-6.4|0.556
71667179|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.089|TWO_SIDED|95.0|-9.5|0.5|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-9.5|0.089
71667180|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-3.7||||0.11|TWO_SIDED|95.0|-9.4|0.8|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.8|-9.4|0.110
71667181|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-4.3||||0.049|TWO_SIDED|95.0|-9.8|0.0|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-9.8|0.049
71667182|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-1.1||||0.621|TWO_SIDED|95.0|-6.2|2.9|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.9|-6.2|0.621
71667183|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-4.4||||0.041|TWO_SIDED|95.0|-10.0|-0.2|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-10.0|0.041
71667184|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-3.8||||0.046|TWO_SIDED|95.0|-8.9|-0.1|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.9|0.046
71667185|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-4.4||||0.037|TWO_SIDED|95.0|-9.9|-0.2|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.2|-9.9|0.037
71667186|NCT01277211|142850098|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.048|TWO_SIDED|95.0|-10.4|0.0|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.0|-10.4|0.048
71667187|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 1|-6.0||||0.015|TWO_SIDED|95.0|-12.0|-1.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.1|-12.0|0.015
71667188|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 2|-4.9||||0.012|TWO_SIDED|95.0|-10.1|-1.0|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-10.1|0.012
71667189|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 3|-6.5||||0.002|TWO_SIDED|95.0|-12.0|-2.2|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.2|-12.0|0.002
71667190|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 4|-3.6||||0.044|TWO_SIDED|95.0|-8.5|-0.1|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-8.5|0.044
71667191|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 5|-1.0||||0.609|TWO_SIDED|95.0|-5.7|2.5|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||2.5|-5.7|0.609
71667192|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 6|-3.9||||0.062|TWO_SIDED|95.0|-9.3|0.2|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.2|-9.3|0.062
71667193|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 7|-4.1||||0.019|TWO_SIDED|95.0|-9.0|-0.6|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.6|-9.0|0.019
71667194|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 8|-1.9||||0.308|TWO_SIDED|95.0|-6.7|1.6|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||1.6|-6.7|0.308
71667195|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 9|-4.2||||0.027|TWO_SIDED|95.0|-9.3|-0.4|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.4|-9.3|0.027
71667196|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 10|-2.9||||0.098|TWO_SIDED|95.0|-7.6|0.5|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||0.5|-7.6|0.098
71667197|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 11|-4.4||||0.009|TWO_SIDED|95.0|-9.4|-1.0|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-1.0|-9.4|0.009
71667198|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 12|-6.2||||0.002|TWO_SIDED|95.0|-11.7|-2.1|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-2.1|-11.7|0.002
71667199|NCT01277211|142850099|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages, Cycle 13|-4.5||||0.043|TWO_SIDED|95.0|-10.2|-0.1|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.||-0.1|-10.2|0.043
71667200|NCT03452943|142850100|OTHER||LS mean difference|-0.7||||0.692|TWO_SIDED|95.0|-4.1|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.8|-4.1|0.692
71667201|NCT03541317|142850118|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of CBT sessions delivered to students by SPs over the four post-randomization phases during Stages 1 and 2|Difference in sum of means*|9.7||||0.63|TWO_SIDED|95.0|-30.03|49.4|||weighted least squares regression|Marginal means under each implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne, \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase.|||49.40|-30.03|0.63
71667202|NCT03541317|142850119|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\<15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|3.78||||0.72|TWO_SIDED|95.0|-16.88|24.44|||weighted least squares regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017)|\*Difference in the sum of the means estimated at each post-randomization phase|||24.44|-16.88|0.72
71667203|NCT03541317|142850120|SUPERIORITY|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of brief individual CBT sessions (\>15 min.) delivered to students by SPs over the four post-randomization phases occurring during Stages 1 and 2.|Difference in sum of means*|7.85||||0.46|TWO_SIDED|95.0|-13.2|28.91|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|||28.91|-13.20|0.46
71667204|NCT03541317|142850121|SUPERIORITY||Difference in sum of means*|-0.66||||0.87|TWO_SIDED|95.0|-8.49|7.16|||Weighted Least Squares Regression|Marginal means under each embedded implementation strategy estimated after each of 4 post-randomization phases (NeCamp, Kilbourne \& Almirall 2017).|Difference in the sum of the means estimated at each post-randomization phase|A test of the null hypothesis that there is no difference between these two strategies on the sum of the average number of group CBT sessions delivered to students by SPs over the four post-randomization phase occurring during Stages 1 and 2.||7.16|-8.49|0.87
71667205|NCT00879086|142850122|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-16.7|||=|0.0941|TWO_SIDED|95.0|-36.1|2.4||The two treatment groups were compared, controlling for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (less than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||2.4|-36.1|=0.0941
71667206|NCT00879086|142850123|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-18.4||||0.0492|TWO_SIDED|95.0|-36.0|-0.3||Controlled for baseline pre-existing neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3), with both covariates included as binary variables.|Cochran-Mantel-Haenszel||Extended Mantel-Haenszel test statistics with stratification adjustment for pre-existing baseline neuropathy (CTCAE Grade 0 or 1) and number of prior chemotherapy regimens (greater than or equal to 3 or greater than 3)|||-0.3|-36.0|0.0492
71835128|NCT00894543|143174990|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
71667207|NCT04604795|142850195|OTHER||Ratio of geometric mean|1.05|||||TWO_SIDED|90.0|0.833|1.331|||||Log transformed Cmax was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.331|0.833|
71667208|NCT04604795|142850195|OTHER||Ratio of geometric mean|6.45|||||TWO_SIDED|90.0|4.916|8.474|||||Log transformed Cmax was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||8.474|4.916|
71667209|NCT04604795|142850204|OTHER||Ratio of geometric mean|1.53|||||TWO_SIDED|90.0|1.268|1.847|||||AUC(0-inf) was analyzed using a mixed model with fixed effects for regimen and period, and participants as random effect.|||1.847|1.268|
71667210|NCT04604795|142850204|OTHER||Ratio of geometric mean|12.51|||||TWO_SIDED|90.0|10.141|15.423|||||Log transformed AUC(0-inf) was analyzed using a mixed model with regimen, period, and regimen by period as fixed effects and participants as random effect.|||15.423|10.141|
71667211|NCT04604795|142850241|OTHER||Ratio of geometric mean|0.47|||||TWO_SIDED|90.0|0.318|0.693|||||Day 5 (High fat meal) versus (vs) Day 3 (fasted)|||0.693|0.318|
71667212|NCT04604795|142850241|OTHER||Ratio of geometric mean|0.6|||||TWO_SIDED|90.0|0.405|0.882|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.882|0.405|
71667213|NCT04604795|142850241|OTHER||Ratio of geometric mean|0.29|||||TWO_SIDED|90.0|0.194|0.427|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.427|0.194|
71667214|NCT04604795|142850241|OTHER||Ratio of geometric mean|0.43|||||TWO_SIDED|90.0|0.292|0.643|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.643|0.292|
71667215|NCT04604795|142850241|OTHER||Ratio of geometric mean|0.42|||||TWO_SIDED|90.0|0.28|0.617|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.617|0.280|
71667216|NCT04604795|142850241|OTHER||Ratio of geometric mean|0.61|||||TWO_SIDED|90.0|0.41|0.903|||||Day 7 (Standard meal) vs Day 3 (fasted)|||0.903|0.410|
71835129|NCT00894543|143174994|SUPERIORITY_OR_OTHER||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.||||<0.001
71667217|NCT04604795|142850243|OTHER||Ratio of geometric mean|1.02|||||TWO_SIDED|90.0|0.867|1.205|||||Day 5 (High fat meal) vs Day 3 (fasted)|||1.205|0.867|
71667218|NCT04604795|142850243|OTHER||Ratio of geometric mean|1.11|||||TWO_SIDED|90.0|0.941|1.308|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.308|0.941|
71667219|NCT04604795|142850243|OTHER||Ratio of geometric mean|0.79|||||TWO_SIDED|90.0|0.671|0.933|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.933|0.671|
71667220|NCT04604795|142850243|OTHER||Ratio of geometric mean|0.85|||||TWO_SIDED|90.0|0.724|1.007|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.007|0.724|
71667221|NCT04604795|142850243|OTHER||Ratio of geometric mean|0.84|||||TWO_SIDED|90.0|0.713|0.992|||||Day 5 (High fat meal) vs Day 3 (fasted)|||0.992|0.713|
71667222|NCT04604795|142850243|OTHER||Ratio of geometric mean|0.99|||||TWO_SIDED|90.0|0.837|1.165|||||Day 7 (Standard meal) vs Day 3 (fasted)|||1.165|0.837|
71667223|NCT00719186|142850261|SUPERIORITY_OR_OTHER|||||||0.007|||||||Chi-squared|||||||0.007
71667224|NCT02096744|142850313|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.33|STANDARD_ERROR_OF_MEAN|19.0|<|0.0001|TWO_SIDED|90.0|95.74|109.37|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||109.37|95.74|<0.0001
71667225|NCT02096744|142850314|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.25|STANDARD_ERROR_OF_MEAN|16.6|<|0.0001|TWO_SIDED|90.0|98.367|110.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.487|98.367|<0.0001
71835130|NCT00894543|143174995|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||||||0.001
71835131|NCT02697136|143174996|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study. Using an assumed standard deviation of 4.5% and a 2:1 randomization scheme to maximize exposure to active drug, 16 completing patients in the CER-001 group and 8 in the placebo group (24 total completers for mITT) would yield 90% power to detect a difference from baseline versus placebo of 6.7%, using two-tailed testing with α=0.05.|Difference in LS Means|-0.08||||0.185|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||||0.4|-1.9|0.185
71667226|NCT02096744|142850315|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.78|STANDARD_ERROR_OF_MEAN|15.8|<|0.0001|TWO_SIDED|90.0|97.25|108.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', 'sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||108.63|97.25|<0.0001
71667227|NCT02096744|142850316|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.04|STANDARD_ERROR_OF_MEAN|16.7|<|0.0001|TWO_SIDED|90.0|98.148|110.294|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group','sequence', 'subjects within sequences', 'period', and 'treatment'.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."|||110.294|98.148|<0.0001
71667228|NCT03048552|142850334|SUPERIORITY|||||||0.148|||||||Fisher Exact|||||||0.148
71667229|NCT03048552|142850335|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
71667230|NCT03048552|142850336|SUPERIORITY|||||||0.818|||||||Fisher Exact|||||||0.818
71667231|NCT03048552|142850338|SUPERIORITY|||||||0.625|||||||Fisher Exact|||||||0.625
71667232|NCT02487225|142850361|SUPERIORITY|||||||0.5796|||||||Kruskal-Wallis|||Admission (baseline)||||0.5796
71667233|NCT02487225|142850361|SUPERIORITY|||||||0.8415|||||||Kruskal-Wallis|||Day 5||||0.8415
71667234|NCT02487225|142850362|SUPERIORITY|||||||0.1109|||||||Kruskal-Wallis|||Admission (baseline)||||0.1109
71667235|NCT02487225|142850362|SUPERIORITY|||||||0.4619|||||||Kruskal-Wallis|||||||0.4619
71667236|NCT02487225|142850363|SUPERIORITY|||||||0.1236|||||||Kruskal-Wallis|||Admission (baseline)||||0.1236
71667237|NCT02487225|142850363|SUPERIORITY|||||||0.9468|||||||Kruskal-Wallis|||Day 5||||0.9468
71667238|NCT02487225|142850364|SUPERIORITY|||||||0.157|||||||Kruskal-Wallis|||Admission (baseline)||||0.157
71667239|NCT02487225|142850364|SUPERIORITY|||||||0.3173|||||||Kruskal-Wallis|||Day 5||||0.3173
71667240|NCT00625872|142850365|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.43|STANDARD_ERROR_OF_MEAN|1.1||0.7232|TWO_SIDED|95.0|-3.93|3.08||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Analysis of covariance (ANCOVA) method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||3.08|-3.93|0.7232
71667241|NCT00625872|142850366|SUPERIORITY_OR_OTHER||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.51||0.1941|TWO_SIDED|95.0|-8.04|4.82||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||4.82|-8.04|0.1941
71667242|NCT00625872|142850368|SUPERIORITY_OR_OTHER|||||||0.0532||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Sequential Processing): Kruskal-Wallis Analysis of Variance (ANOVA) model was used to calculate p-value.||||0.0532
71667243|NCT00625872|142850368|SUPERIORITY_OR_OTHER|||||||0.3383||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Simultaneous Processing): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3383
71667244|NCT00625872|142850368|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Achievement): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6830
71667245|NCT00625872|142850368|SUPERIORITY_OR_OTHER|||||||0.4935||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Non-Verbal): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.4935
71667246|NCT00625872|142850368|SUPERIORITY_OR_OTHER|||||||0.3458||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Mental Processing Composite): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3458
71667247|NCT00625872|142850370|SUPERIORITY_OR_OTHER|||||||0.6256||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Distractibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.6256
71667248|NCT00625872|142850370|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Alertness): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.8590
71667249|NCT00625872|142850370|SUPERIORITY_OR_OTHER|||||||1||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Flexibility): Kruskal-Wallis ANOVA model was used to calculate p-value.||||1.0000
71667250|NCT00625872|142850370|SUPERIORITY_OR_OTHER|||||||0.1234||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Go/No Go): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.1234
71667251|NCT00625872|142850370|SUPERIORITY_OR_OTHER|||||||0.3291||95.0||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Vigilance): Kruskal-Wallis ANOVA model was used to calculate p-value.||||0.3291
71667252|NCT00625872|142850389|SUPERIORITY_OR_OTHER||LS Mean difference|0.14|STANDARD_ERROR_OF_MEAN|2.54||0.956|TWO_SIDED|95.0|-5.71|6.0||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||6.00|-5.71|0.9560
71667253|NCT00625872|142850405|SUPERIORITY_OR_OTHER||LS Mean difference|0.55|STANDARD_ERROR_OF_MEAN|0.31||0.1107|TWO_SIDED|95.0|-0.15|1.25||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||1.25|-0.15|0.1107
71667254|NCT00625872|142850407|SUPERIORITY_OR_OTHER||LS Mean difference|4.67|STANDARD_ERROR_OF_MEAN|1.54||0.0161|TWO_SIDED|95.0|1.13|8.21||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||8.21|1.13|0.0161
71667255|NCT00625872|142850416|SUPERIORITY_OR_OTHER||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.25||0.187|TWO_SIDED|95.0|-0.89|0.2||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Triceps SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.20|-0.89|0.1870
71780820|NCT01817530|143061429|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780821|NCT01817530|143061429|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
71780822|NCT01817530|143061429|SUPERIORITY|||||||0.329||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.329
71780823|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71667256|NCT00625872|142850416|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15||0.3494|TWO_SIDED|95.0|-0.49|0.19||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Subscapular SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||0.19|-0.49|0.3494
71748524|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.121|TWO_SIDED|95.0|-0.43|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.05|-0.43|0.1210
71748525|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0369|TWO_SIDED|95.0|-0.52|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.02|-0.52|0.0369
71748526|NCT03192176|143005295|SUPERIORITY||LSMean differencce|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5855|TWO_SIDED|95.0|-0.32|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.18|-0.32|0.5855
71748527|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0041|TWO_SIDED|95.0|-0.62|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.12|-0.62|0.0041
71748528|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0614|TWO_SIDED|95.0|-0.5|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.01|-0.50|0.0614
71748529|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3391|TWO_SIDED|95.0|-0.36|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.12|-0.36|0.3391
71748530|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0515|TWO_SIDED|95.0|-0.49|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.00|-0.49|0.0515
71748531|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0667|TWO_SIDED|95.0|-0.47|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.02|-0.47|0.0667
71748532|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0047|TWO_SIDED|95.0|-0.63|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.63|0.0047
71748533|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.513|TWO_SIDED|95.0|-0.34|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.34|0.5130
71748534|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.75|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.23|-0.75|0.0002
71748535|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0126|TWO_SIDED|95.0|-0.6|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.07|-0.60|0.0126
71748536|NCT03192176|143005295|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3507|TWO_SIDED|95.0|-0.36|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.13|-0.36|0.3507
71748537|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0098|TWO_SIDED|95.0|-0.6|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.08|-0.60|0.0098
71748538|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED|95.0|-0.63|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.11|-0.63|0.0048
71748539|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.28|-0.80|<0.0001
71748540|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.47|-1.00|<0.0001
71780824|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780825|NCT01817530|143061430|SUPERIORITY|||||||0.036||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||0.036
71780826|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780827|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780828|NCT01817530|143061430|SUPERIORITY|||||||0.04||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||0.040
71780829|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780830|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||||||< 0.001
71780831|NCT01817530|143061430|SUPERIORITY|||||||0.098||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.098
71780832|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780833|NCT01817530|143061430|SUPERIORITY|||||||0.014||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.014
71780834|NCT01817530|143061430|SUPERIORITY|||||||0.409||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||0.409
71780835|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780836|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780837|NCT01817530|143061430|SUPERIORITY|||||||0.094||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.094
71780838|NCT01817530|143061430|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780839|NCT01817530|143061430|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.002
71780840|NCT01817530|143061430|SUPERIORITY|||||||0.393||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||0.393
71780841|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780842|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780843|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780844|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780845|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 3||||< 0.001
71780846|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780847|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780848|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780849|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780850|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780851|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Month 6||||< 0.001
71780852|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780853|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71748541|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6761|TWO_SIDED|95.0|-0.32|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.21|-0.32|0.6761
71748542|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0188|TWO_SIDED|95.0|-0.57|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.05|-0.57|0.0188
71748543|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0067|TWO_SIDED|95.0|-0.61|-0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.10|-0.61|0.0067
71748544|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0335|TWO_SIDED|95.0|-0.68|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.03|-0.68|0.0335
71748545|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.91|-0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.25|-0.91|0.0007
71748546|NCT03192176|143005296|SUPERIORITY||LSMean differencce|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.14|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.48|-1.14|<0.0001
71748547|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.41|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.74|-1.41|<0.0001
71667257|NCT00625872|142850416|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0458|TWO_SIDED|95.0|-0.54|-0.01||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Suprailiac SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.||-0.01|-0.54|0.0458
71667258|NCT04208750|142850418|OTHER|Difference between independent proportions||||||||||||||||Added the number of participants from each study arm who preferred each refraction type and then converted it to the proportions|For each outcome, we compared the proportion of participants from both study arms who preferred the VR800 refraction to the proportion of participants who preferred the Standard refraction using a 2-sample test for equality of proportions.|||
71667259|NCT00852202|142850450|SUPERIORITY|||||||0.7408|||||||ANCOVA|||||||0.7408
71667260|NCT00852202|142850450|SUPERIORITY|||||||0.9961|||||||ANCOVA|||||||0.9961
71667261|NCT00852202|142850451|SUPERIORITY|||||||0.3441|||||||ANCOVA|||||||0.3441
71667262|NCT00852202|142850451|SUPERIORITY|||||||0.2683|||||||ANCOVA|||||||0.2683
71748548|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3227|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||0.17|-0.50|0.3227
71748549|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0085|TWO_SIDED|95.0|-0.77|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.11|-0.77|0.0085
71748550|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.95|-0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.30|-0.95|0.0002
71748551|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0102|TWO_SIDED|95.0|-0.87|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.12|-0.87|0.0102
71780854|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780855|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780856|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780857|NCT01817530|143061431|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.|Kruskal-Wallis|||Final Visit||||< 0.001
71780858|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71780859|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71667263|NCT02972892|142850452|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|10.9|||<|0.001|TWO_SIDED|95.0|6.89|15.01|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||15.01|6.89|<.001
71667264|NCT02972892|142850453|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.|Mean Difference (Net)|52.1|||<|0.001|TWO_SIDED|95.0|46.25|57.95|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device was performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for both EtAA.||57.95|46.25|<.001
71667265|NCT02972892|142850454|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|2.64|8.04|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||8.04|2.64|<.001
71667266|NCT02972892|142850455|NON_INFERIORITY|Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.|Mean Difference (Net)|44.5|||<|0.001|TWO_SIDED|95.0|35.56|53.41|||t-test, 2 sided|||Using t-test, comparison of the weighted average percent duration between the Et Control and control device will be performed by calculating the difference and its 95% 2-sided confidence interval between the two arms. Non-inferiority will be concluded if the lower limit of the 95% confidence interval is ≥ -5% for EtO2.||53.41|35.56|<.001
71667267|NCT01682811|142850481|OTHER|||||||0.0001|||||||t-test, 1 sided|||One-sample t-test comparing the absolute value to an alternate expected value of zero.||||0.0001
71835132|NCT02697136|143174997|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.8|||Mixed Models Analysis|||||1.8|-0.4|0.217
71835133|NCT02697136|143174998|OTHER|Linear mixed model to test for superiority and non-inferiority. Equivalence was defined as a difference of less than 6.7% in MVWA, based on a pilot study.|Difference in LS Means|-0.2||||0.832|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||||1.3|-1.6|0.832
71835134|NCT05198310|143175006|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.281||0.047|TWO_SIDED|95.0|-1.13|-0.01||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||-0.01|-1.13|0.0470
71835135|NCT05198310|143175006|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.282||0.2124|TWO_SIDED|95.0|-0.92|0.21||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.21|-0.92|0.2124
71835136|NCT05198310|143175006|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.352||0.1091|TWO_SIDED|95.0|-1.28|0.13||Analyzed using ANCOVA model with baseline value and stratification factor (≤1 vs. ≥2 classes of advanced targeted therapies) as covariates.|ANCOVA|||||0.13|-1.28|0.1091
71835137|NCT05198310|143175007|SUPERIORITY|||||||0.0312|||||||t-test|||||||0.0312
71835138|NCT05198310|143175007|SUPERIORITY|||||||0.0338|||||||t-test|||||||0.0338
71835139|NCT05198310|143175011|SUPERIORITY|||||||0.0333|||||||Fisher exact test|||||||0.0333
71835140|NCT05198310|143175011|SUPERIORITY|||||||0.1905|||||||Fisher exact test|||||||0.1905
71835141|NCT05198310|143175011|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0716|TWO_SIDED|95.0|0.9|9.65|||Cochran-Mantel-Haenszel|||||9.65|0.90|0.0716
71667268|NCT01682811|142850484|OTHER|||||||0.24|||||||t-test, 2 sided|||Paired comparisons between treated and placebo lesions within subject.||||0.24
71667269|NCT01682811|142850487|OTHER|||||||0.002|||||||t-test, 2 sided|||||||0.002
71667270|NCT02694328|142850488|SUPERIORITY||Least Squares Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|0.765||0.003|TWO_SIDED|95.0|-3.88|-0.88||P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.|ANCOVA|Missing values at Week 24 were imputed using multiple imputation.||||-0.88|-3.88|0.003
71835142|NCT05198310|143175011|SUPERIORITY||Odds Ratio (OR)|1.52||||0.471|TWO_SIDED|95.0|0.5|4.67|||Cochran-Mantel-Haenszel|||||4.67|0.50|0.4710
71835143|NCT05198310|143175011|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0057|TWO_SIDED|95.0|1.62|22.88|||Cochran-Mantel-Haenszel|||||22.88|1.62|0.0057
71835144|NCT05198310|143175012|SUPERIORITY|||||||0.0762|||||||Fisher exact test|||||||0.0762
71835145|NCT05198310|143175012|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.000
71835146|NCT05198310|143175012|SUPERIORITY||Odds Ratio (OR)|1.67||||0.4172|TWO_SIDED|95.0|0.49|5.62|||Cochran-Mantel-Haenszel|||||5.62|0.49|0.4172
71835147|NCT05198310|143175012|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3144|TWO_SIDED|95.0|0.55|6.45|||Cochran-Mantel-Haenszel|||||6.45|0.55|0.3144
71835148|NCT05198310|143175012|SUPERIORITY||Odds Ratio (OR)|0.97||||0.956|TWO_SIDED|95.0|0.28|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.28|0.9560
71835149|NCT05198310|143175013|SUPERIORITY|||||||0.4667|||||||Fisher exact test|||||||0.4667
71835150|NCT05198310|143175013|SUPERIORITY|||||||1|||||||Fisher exact test|||||||1.0000
71835151|NCT05198310|143175013|SUPERIORITY||Odds Ratio (OR)|1.95||||0.5789|TWO_SIDED|95.0|0.17|22.3|||Cochran-Mantel-Haenszel|||||22.30|0.17|0.5789
71835152|NCT05198310|143175013|SUPERIORITY||Odds Ratio (OR)|6.12||||0.0799|TWO_SIDED|95.0|0.62|60.1|||Cochran-Mantel-Haenszel|||||60.10|0.62|0.0799
71667271|NCT02694328|142850489|SUPERIORITY||Risk Difference (RD)|-13.7||||0.003|TWO_SIDED|95.0|-22.8|-4.6||P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.|Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) of ALKS 3831 vs. Olanzapine|||-4.6|-22.8|0.003
71667272|NCT02694328|142850490|SUPERIORITY||Risk Difference (RD)|-15.9||||0.001|TWO_SIDED|95.0|-25.3|-6.5|||Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) ALKS 3831 vs. Olanzapine|||-6.5|-25.3|0.001
71667273|NCT02731638|142850497|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.65|5.23|||Regression, Logistic|Bias-corrected logistic regression, accounting for baseline culture status||||5.23|0.65|0.26
71667274|NCT02731638|142850498|SUPERIORITY||Coefficient|1.6||||0.25|TWO_SIDED|95.0|-1.2|4.4|||Regression, Linear||Positive coefficients of the logMAR value indicated worsened visual acuity|||4.4|-1.2|0.25
71667275|NCT02731638|142850498|SUPERIORITY||Coefficient|0.5||||0.75|TWO_SIDED|95.0|-2.6|3.6|||Regression, Linear||Positive coefficients of the logMAR value indicate worsened visual acuity|||3.6|-2.6|0.75
71667276|NCT05878093|142850510|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.84|||<|0.0001|TWO_SIDED|95.0|-2.53|-1.15|||ANCOVA||Data was analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-1.15|-2.53|<0.0001
71667277|NCT05878093|142850511|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.54||||0.0126|TWO_SIDED|95.0|-0.97|-0.12|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.12|-0.97|0.0126
71667278|NCT05878093|142850512|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-1.68||||0.0008|TWO_SIDED|95.0|-2.67|-0.69|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.69|-2.67|0.0008
71667279|NCT05878093|142850513|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-0.62||||0.0072|TWO_SIDED|95.0|-1.08|-0.17|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-0.17|-1.08|0.0072
71667280|NCT05878093|142850514|SUPERIORITY|A hierarchical procedure was used to control type I error and handle primary and first 4 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|Least square mean difference|-9.52||||0.0104|TWO_SIDED|95.0|-16.81|-2.24|||ANCOVA||Data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, and screening blood eosinophil count strata as covariates.|||-2.24|-16.81|0.0104
71667281|NCT04100018|142850522|SUPERIORITY||Cox Proportional Hazard|0.96||||0.5901|TWO_SIDED|99.0|0.77|1.19||Boundary for statistical significance p-value \< 0.01|Log Rank|Stratification factor is visceral disease (YES vs NO) as entered in the IRT.||||1.19|0.77|0.5901
71667282|NCT04100018|142850523|SUPERIORITY||Cox Proportional Hazard|1.09||||0.3572|TWO_SIDED|99.41|0.84|1.43||Boundary for statistical significance p-value \< 0.0059. Additional accuracy for p-value: 0.005866.|Log Rank||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.43|0.84|0.3572
71667283|NCT04100018|142850524|SUPERIORITY||Adjusted Difference|3.8|||||TWO_SIDED|95.0|-4.5|12.1|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||12.1|-4.5|
71667284|NCT04100018|142850527|SUPERIORITY||Percentage Difference|0.9|||||TWO_SIDED|95.0|-5.2|7.0|||||Strata adjusted difference in objective response rate based on DerSimonian and Laird method. Stratified by visceral disease (YES vs NO) as entered in the IRT.|||7.0|-5.2|
71667285|NCT04100018|142850528|SUPERIORITY||Cox Proportional Hazard|1.0|||||TWO_SIDED|95.0|0.86|1.16|||||Stratification factor is visceral disease (YES vs NO) as entered in the IRT.|||1.16|0.86|
71667286|NCT05736861|142850539|SUPERIORITY|Decision rule based on Bayesian posterior probability of efficacy. The decision threshold was a posterior probability of 0.95. A prespecified skeptical prior for the treatment effect was used to preserve type I error below 0.05.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.96|1.17|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.17|0.96|
71667287|NCT05736861|142850540|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.4|2.6|||||The interval is a highest-density credible interval. Descriptive analysis is a maximum partial likelihood proportional hazards regression model. Low event rate precluded covariate adjustment.|||2.6|0.4|
71667288|NCT05736861|142850543|SUPERIORITY|Statistical analysis was a Bayesian proportional hazards regression model with covariate adjustment and weakly informative priors.|Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.6|1.8|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.8|0.6|
71667289|NCT05736861|142850544|SUPERIORITY|Statistical analysis was a Bayesian cumulative probability ordinal regression model with covariate adjustment and weakly informative priors.|Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.5|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.50|
71667290|NCT05736861|142850545|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.13|||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|||1.13|0.39|
71667291|NCT05736861|142850546|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.52|1.91|||||||The interval is a highest-density credible interval on the log relative odds scale. Odds ratio estimate from a Bayesian cumulative probability ordinal regression model with weakly informative priors.|1.91|0.52|
71748552|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.15|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.39|-1.15|<0.0001
71748553|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.54|-1.29|<0.0001
71748554|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.46|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.68|-1.46|<0.0001
71748555|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.074|TWO_SIDED|95.0|-0.73|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||0.03|-0.73|0.0740
71748556|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0024|TWO_SIDED|95.0|-0.97|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.21|-0.97|0.0024
71748557|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.17|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-0.41|-1.17|<0.0001
71748558|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1197|TWO_SIDED|95.0|-0.72|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.08|-0.72|0.1197
71748559|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0046|TWO_SIDED|95.0|-0.98|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.18|-0.98|0.0046
71748560|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.28|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.47|-1.28|<0.0001
71835153|NCT05198310|143175013|SUPERIORITY||Odds Ratio (OR)|0.28||||0.1034|TWO_SIDED|95.0|0.06|1.35|||Cochran-Mantel-Haenszel|||||1.35|0.06|0.1034
71748561|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.51|-0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.69|-1.51|<0.0001
71748562|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0553|TWO_SIDED|95.0|-0.8|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.01|-0.80|0.0553
71748563|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0823|TWO_SIDED|95.0|-0.76|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||0.05|-0.76|0.0823
71748564|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.006|TWO_SIDED|95.0|-0.96|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-0.16|-0.96|0.0060
71748565|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0374|TWO_SIDED|95.0|-0.83|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.03|-0.83|0.0374
71748566|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.21||0.0042|TWO_SIDED|95.0|-1.0|-0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.19|-1.00|0.0042
71748567|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.38|-0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.56|-1.38|<0.0001
71748568|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.54|-0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.71|-1.54|<0.0001
71748569|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.071|TWO_SIDED|95.0|-0.79|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||0.03|-0.79|0.0710
71748570|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.016|TWO_SIDED|95.0|-0.91|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.09|-0.91|0.0160
71748571|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0003|TWO_SIDED|95.0|-1.15|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-0.34|-1.15|0.0003
71748572|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1013|TWO_SIDED|95.0|-0.76|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||0.07|-0.76|0.1013
71780860|NCT01817530|143061432|SUPERIORITY|||||||0.02||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.020
71780861|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71667292|NCT05736861|142850547|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.82|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.25|0.82|
71845290|NCT02232737|143204417|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
71667293|NCT05736861|142850547|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.23|0.78|
71667294|NCT05736861|142850547|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.41|0.82|
71667295|NCT05736861|142850547|OTHER||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.57|1.01|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.01|0.57|
71667296|NCT05736861|142850548|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.92|1.32|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.32|0.92|
71667297|NCT05736861|142850548|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.22|0.83|
71748573|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0011|TWO_SIDED|95.0|-1.11|-0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.28|-1.11|0.0011
71748574|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.36|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.53|-1.36|<0.0001
71748575|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.57|-0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.72|-1.57|<0.0001
71748576|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0476|TWO_SIDED|95.0|-0.85|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.00|-0.85|0.0476
71780862|NCT01817530|143061432|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.002
71780863|NCT01817530|143061432|SUPERIORITY|||||||0.061||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.061
71667298|NCT05736861|142850548|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.83|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.24|0.83|
71748577|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.022|TWO_SIDED|95.0|-0.9|-0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.07|-0.90|0.0220
71748578|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0019|TWO_SIDED|95.0|-1.07|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.24|-1.07|0.0019
71748579|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1457|TWO_SIDED|95.0|-0.74|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.11|-0.74|0.1457
71748580|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0284|TWO_SIDED|95.0|-0.91|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.05|-0.91|0.0284
71748581|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.26|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.39|-1.26|0.0002
71748582|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.36|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.48|-1.36|<0.0001
71748583|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4223|TWO_SIDED|95.0|-0.61|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.26|-0.61|0.4223
71748584|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0442|TWO_SIDED|95.0|-0.87|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.01|-0.87|0.0442
71748585|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0071|TWO_SIDED|95.0|-1.02|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.16|-1.02|0.0071
71748586|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0823|TWO_SIDED|95.0|-0.8|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.05|-0.80|0.0823
71748587|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0336|TWO_SIDED|95.0|-0.89|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.04|-0.89|0.0336
71748588|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.32|-0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.46|-1.32|<0.0001
71748589|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.47|-1.34|<0.0001
71780864|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71780865|NCT01817530|143061432|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.004
71780866|NCT01817530|143061432|SUPERIORITY|||||||0.085||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.085
71780867|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71780868|NCT01817530|143061432|SUPERIORITY|||||||0.012||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.012
71780869|NCT01817530|143061432|SUPERIORITY|||||||0.049||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.049
71667299|NCT05736861|142850548|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.72|1.1||||||Day 90|Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|1.10|0.72|
71748590|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.4819|TWO_SIDED|95.0|-0.59|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.28|-0.59|0.4819
71748591|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0371|TWO_SIDED|95.0|-0.88|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.03|-0.88|0.0371
71748592|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0121|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.12|-0.97|0.0121
71748593|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0281|TWO_SIDED|95.0|-0.89|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.05|-0.89|0.0281
71748594|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0436|TWO_SIDED|95.0|-0.86|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.01|-0.86|0.0436
71748595|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.49|-1.34|<0.0001
71748596|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.47|-0.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.60|-1.47|<0.0001
71748597|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1488|TWO_SIDED|95.0|-0.75|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||0.11|-0.75|0.1488
71748598|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0251|TWO_SIDED|95.0|-0.91|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.06|-0.91|0.0251
71845291|NCT02232737|143204417|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
71845292|NCT00786864|143204435|SUPERIORITY_OR_OTHER||||||p=|0||95.0|||||ANCOVA|||||||p=0.001
71845293|NCT00786864|143204436|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
71748599|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0027|TWO_SIDED|95.0|-1.08|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-0.23|-1.08|0.0027
71748600|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1053|TWO_SIDED|95.0|-0.77|0.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.07|-0.77|0.1053
71748601|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0304|TWO_SIDED|95.0|-0.9|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.04|-0.90|0.0304
71748602|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.33|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.43|-1.33|<0.0001
71748603|NCT03192176|143005296|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.49|-0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.61|-1.49|<0.0001
71748604|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0873|TWO_SIDED|95.0|-0.81|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||0.06|-0.81|0.0873
71845294|NCT00786864|143204437|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.001
71835154|NCT01095796|143175014|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.6|||||TWO_SIDED|95.2|-1.6|8.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the percentage of participants achieving HIV-1 RNA \< 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.||8.8|-1.6|
71667300|NCT05736861|142850549|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.20|0.80|
71667301|NCT05736861|142850549|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.78|1.25|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.25|0.78|
71667302|NCT05736861|142850549|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.43|0.86|
71667303|NCT05736861|142850549|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.66|1.12|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.12|0.66|
71667304|NCT05736861|142850550|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.87|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.35|0.87|
71667305|NCT05736861|142850550|OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.57|0.96|
71667306|NCT05736861|142850550|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.54|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.54|0.92|
71667307|NCT05736861|142850550|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.18|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.18|0.71|
71667308|NCT05736861|142850551|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.97|1.47|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.47|0.97|
71667309|NCT05736861|142850551|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.84|1.33|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.33|0.84|
71835155|NCT01424670|143175048|SUPERIORITY|||||||0.0562||||||For testing the null hypothesis, the distribution of the time to SCC within the 6-month Intensive Period were compared between the 2 treatment groups using the stratified modified Peto-Peto modification of Gehan's Wilcoxon rank sum test.|Modified Peto-Peto test|||Comparison of distributions of time to SCC using the MGIT culture system during the 6-month (26-week) Intensive Period.||||0.0562
71845295|NCT00786864|143204438|SUPERIORITY_OR_OTHER||||||p<|0||95.0|||||ANCOVA|||||||p<0.01
71667310|NCT05736861|142850551|OTHER||Odds Ratio (OR)|1.21|||||TWO_SIDED|95.0|0.95|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.55|0.95|
71667311|NCT05736861|142850551|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.19|0.73|
71667312|NCT05736861|142850552|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.86|1.26|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.26|0.86|
71667313|NCT05736861|142850552|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.85|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.29|0.85|
71667314|NCT05736861|142850552|OTHER||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.85|1.34|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.34|0.85|
71667315|NCT05736861|142850552|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.28|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.28|0.80|
71667316|NCT05736861|142850553|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.88|1.27|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 7||1.27|0.88|
71667317|NCT05736861|142850553|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.79|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 14||1.14|0.79|
71667318|NCT05736861|142850553|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.75|1.09|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 28||1.09|0.75|
71667319|NCT05736861|142850553|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.93|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is symmetric density Bayesian credible interval.|Day 90||1.36|0.93|
71667320|NCT05736861|142850554|SUPERIORITY||Difference in model estimate time unwell|-0.49|||||TWO_SIDED|95.0|-0.82|-0.15|||||The interval is a highest-density credible interval.|||-0.15|-0.82|
71667321|NCT05736861|142850555|SUPERIORITY||Difference in model estimated means|0.59|||||TWO_SIDED|95.0|0.18|0.99|||||The interval is a highest-density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.99|0.18|
71667322|NCT00879255|142850556|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.75|||>|0.05|TWO_SIDED|95.0|-11.92|2.42||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority analysis|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.42|-11.92|> .05
71667323|NCT00879255|142850557|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.76|||>|0.05|TWO_SIDED|95.0|-11.65|2.13||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority design|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||2.13|-11.65|> .05
71667324|NCT00879255|142850558|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-5.56|||>|0.05|TWO_SIDED|95.0|-16.26|5.14||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority test|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).|||5.14|-16.26|> .05
71835156|NCT01424670|143175049|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.096||||0.3818|TWO_SIDED|95.0|0.889|1.352|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 2 months.||1.352|0.889|0.3818
71891470|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.0269|TWO_SIDED|95.0|0.006|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.105|0.006|0.0269
71667325|NCT03860974|142850565|NON_INFERIORITY|"We tested the non-inferiority of serratus block compared with PVB using the 95% CI associated with the Wilcoxon-Mann-Whitney test with continuity correction. If the lower limit of the 95% CI for median average PACU pain scores was greater than -1.25 , we would conclude non-inferiority. The non-inferiority of serratus blocks with regard to opioid consumption was similarly tested to a predefined non-inferiority margin of 2 mg intravenous morphine equivalents."|Median Difference (Final Values)|4.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71835157|NCT01424670|143175049|SUPERIORITY|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.017||||0.7131|TWO_SIDED|95.0|0.927|1.115|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 6 months.||1.115|0.927|0.7131
71748605|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0124|TWO_SIDED|95.0|-0.97|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.12|-0.97|0.0124
71748606|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22||0.0014|TWO_SIDED|95.0|-1.12|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-0.27|-1.12|0.0014
71748607|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0479|TWO_SIDED|95.0|-0.68|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.00|-0.68|0.0479
71748608|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2342|TWO_SIDED|95.0|-0.54|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.13|-0.54|0.2342
71748609|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.007|TWO_SIDED|95.0|-0.84|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.84|0.0070
71748610|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4291|TWO_SIDED|95.0|-0.49|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.21|-0.49|0.4291
71748611|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0076|TWO_SIDED|95.0|-0.83|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.13|-0.83|0.0076
71780870|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71667326|NCT01499095|142850583|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.066|||TWO_SIDED|95.0|-0.139|0.119||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.119|-0.139|
71667327|NCT01499095|142850584|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.77||||0.038|TWO_SIDED|95.0|0.61|0.99|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.99|0.61|0.0380
71748612|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1506|TWO_SIDED|95.0|-0.62|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.10|-0.62|0.1506
71748613|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.5479|TWO_SIDED|95.0|-0.44|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||0.24|-0.44|0.5479
71748614|NCT03192176|143005296|SUPERIORITY||LSMean differencce|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.1427|TWO_SIDED|95.0|-0.57|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.57|0.1427
71748615|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1498|TWO_SIDED|95.0|-0.56|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.09|-0.56|0.1498
71748616|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0103|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0103
71748617|NCT03192176|143005296|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8984|TWO_SIDED|95.0|-0.36|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.32|-0.36|0.8984
71780871|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71667328|NCT01499095|142850585|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.201||0.8279|TWO_SIDED|95.0|-0.438|0.35|||ANCOVA|||Change in pre-injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.||0.350|-0.438|0.8279
71667329|NCT01499095|142850594|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.152|0.415||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.||0.415|-0.152|
71667330|NCT01130532|142850612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71667331|NCT01130532|142850612|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71667332|NCT01130532|142850613|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667333|NCT01130532|142850613|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|0.68|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667334|NCT01130532|142850614|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667335|NCT01130532|142850614|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667336|NCT01130532|142850615|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667337|NCT01130532|142850615|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667338|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|2.28|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71780872|NCT01817530|143061432|SUPERIORITY|||||||0.056||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.056
71667339|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|9.6|STANDARD_ERROR_OF_MEAN|2.26|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667340|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667341|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|3.12|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667342|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|STANDARD_ERROR_OF_MEAN|3.53|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667343|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667344|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|32.7|STANDARD_ERROR_OF_MEAN|3.82|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71780873|NCT01817530|143061432|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71667345|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|3.79|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667346|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|STANDARD_ERROR_OF_MEAN|3.78|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71835158|NCT01424670|143175050|SUPERIORITY||Relative Ratio of Probability|0.969||||0.5945|TWO_SIDED|95.0|0.866|1.084|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 18.||1.084|0.866|0.5945
71667347|NCT01130532|142850616|SUPERIORITY_OR_OTHER||LS Mean Difference|30.5|STANDARD_ERROR_OF_MEAN|3.75|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667348|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1|STANDARD_ERROR_OF_MEAN|2.49|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667349|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667350|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|2.36|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667351|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667352|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667353|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667354|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|2.54|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667355|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|28.7|STANDARD_ERROR_OF_MEAN|2.53|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667356|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|STANDARD_ERROR_OF_MEAN|2.65|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667357|NCT01130532|142850617|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1|STANDARD_ERROR_OF_MEAN|2.64|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667358|NCT01130532|142850618|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9|STANDARD_ERROR_OF_MEAN|2.77|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71891471|NCT01431287|143304561|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.025||0.4343|TWO_SIDED|95.0|-0.03|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.069|-0.030|0.4343
71667359|NCT01130532|142850618|SUPERIORITY_OR_OTHER||LS Mean Difference|31.0|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71667360|NCT01130532|142850619|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667361|NCT01130532|142850619|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667362|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|2.81|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667363|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.78|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71891472|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.198|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.248||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.248|0.148|<0.0001
71891473|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.146|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.096|0.197||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.197|0.096|<0.0001
71891474|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.158|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.258|0.158|<0.0001
71667364|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|22.3|STANDARD_ERROR_OF_MEAN|2.46|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667365|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667366|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|16.9|STANDARD_ERROR_OF_MEAN|2.37|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71891475|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.143|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.242|0.143|<0.0001
71667367|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2|STANDARD_ERROR_OF_MEAN|2.35|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667368|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|25.2|STANDARD_ERROR_OF_MEAN|2.57|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667369|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.56|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667370|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1|STANDARD_ERROR_OF_MEAN|2.88|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667371|NCT01130532|142850620|SUPERIORITY_OR_OTHER||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|2.86|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA|||||||<0.001
71667372|NCT01130532|142850621|SUPERIORITY_OR_OTHER||LS Mean Difference|25.1|STANDARD_ERROR_OF_MEAN|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71667373|NCT01130532|142850621|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|STANDARD_ERROR_OF_MEAN|2.74|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA|||||||<0.001
71667374|NCT01130532|142850623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71667375|NCT01130532|142850623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71835159|NCT01424670|143175050|SUPERIORITY||Relative Ratio of Probability|0.97||||0.6164|TWO_SIDED|95.0|0.864|1.089|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 24.||1.089|0.864|0.6164
71667376|NCT01130532|142850623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71667377|NCT01130532|142850624|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.002
71667378|NCT01130532|142850624|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||0.004
71667379|NCT01130532|142850624|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test|||||||<0.001
71667380|NCT03041311|142850637|SUPERIORITY||||||<|0.0001|ONE_SIDED|95.0||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect.||||<0.0001
71667381|NCT03041311|142850638|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline ANC count as a covariate, the stratification factors of ECOG performance status (0 to1 vs. 2) and brain metastases (Yes vs. No), and treatment as a fixed effect. The logarithm transformation of # of Induction cycles was included as an offset variable in the modeling.||||<0.0001
71667382|NCT03041311|142850639|SUPERIORITY|||||||0.0195||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|negative binomial regression|Hochberg-based gatekeeping procedure||||||0.0195
71667383|NCT03041311|142850640|SUPERIORITY|||||||0.1335||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model. The model included baseline hemoglobin as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No) and treatment as a fixed effect. The logarithm transformation of the number of weeks on treatment was included as an offset variable in the model.||||0.1335
71667384|NCT03041311|142850641|SUPERIORITY|||||||0.0686||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (for 2 primary and 3 key secondary endpoints) in a strong sense at a 1-sided 0.025 level.|Modified Poisson|Hochberg-based gatekeeping procedure||Treatment group difference was analyzed using a modified Poisson regression model to account for the variable duration of the Induction Period for each patient. The model included baseline absolute neutrophil count as a covariate, the stratification factors of ECOG performance status (0 to 1 versus 2) and brain metastases (Yes versus No), and treatment as a fixed effect. The logarithm transformation of number of Induction cycles was included as an offset variable in the modeling.||||0.0686
71835160|NCT01424670|143175050|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 30.||1.127|0.872|0.8951
71845296|NCT03442777|143204475|SUPERIORITY||Risk Ratio (RR)|0.64||||0.04|TWO_SIDED|95.0|0.41|0.99||controlled for type of ward (ICU/Non-ICU)|Cochran-Mantel-Haenszel|||||0.99|0.41|0.04
71667385|NCT03041311|142850642|SUPERIORITY|For time-to-event variable, the Kaplan-Meier method was used to estimate its within group median value, 25% and 75% percentile values.|Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.218||0.9942|TWO_SIDED|95.0|0.64|1.52||The 2-sided p-value was obtained from the stratified log-rank test to account for the stratification factors.|Log Rank|stratified log-rank test|The HR and its 95% CI were calculated using the Cox proportional hazard regression model with treatment and stratification factors of ECOG performance status (0 to 1 versus 2) and presence of brain metastases (Yes versus No).|||1.52|0.64|0.9942
71667386|NCT01295112|142850676|SUPERIORITY|||||||2e-05|||||||Cochran-Mantel-Haenszel|||||||0.00002
71667387|NCT01295112|142850677|NON_INFERIORITY|Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA|Mean Difference (Final Values)|2.51|STANDARD_DEVIATION|17.96||0.53|TWO_SIDED|90.0|-4.43|9.74||The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.|t-test, 1 sided|||||9.74|-4.43|0.53
71780874|NCT01817530|143061432|SUPERIORITY|||||||0.005||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.005
71748618|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0095|TWO_SIDED|95.0|-0.79|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.11|-0.79|0.0095
71748619|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.137|TWO_SIDED|95.0|-0.6|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.08|-0.60|0.1370
71748620|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4223|TWO_SIDED|95.0|-0.46|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.19|-0.46|0.4223
71748621|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3265|TWO_SIDED|95.0|-0.5|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.17|-0.50|0.3265
71748622|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0852|TWO_SIDED|95.0|-0.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.04|-0.62|0.0852
71748623|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.18||0.0021|TWO_SIDED|95.0|-0.91|-0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.21|-0.91|0.0021
71667388|NCT01811472|142850691|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-1.69||||0.3128|TWO_SIDED|90.0|-4.46|1.09|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.||1.09|-4.46|0.3128
71748624|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5717|TWO_SIDED|95.0|-0.45|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.25|-0.45|0.5717
71748625|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0084|TWO_SIDED|95.0|-0.82|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.12|-0.82|0.0084
71748626|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||-0.04|-0.75|0.0277
71748627|NCT03192176|143005296|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.4627|TWO_SIDED|95.0|-0.46|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.21|-0.46|0.4627
71748628|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0142|TWO_SIDED|95.0|-8.62|-0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-0.97|-8.62|0.0142
71780875|NCT01817530|143061432|SUPERIORITY|||||||0.088||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.088
71780876|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71780877|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71667389|NCT01811472|142850691|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of -5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-2.89||||0.0457|TWO_SIDED|90.0|-5.25|-0.53|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.||-0.53|-5.25|0.0457
71748629|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-11.73|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.05|-11.73|<0.0001
71748630|NCT03192176|143005297|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.98|-5.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.31|-12.98|<0.0001
71748631|NCT03192176|143005297|SUPERIORITY||LSMean difference|-10.5|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-14.39|-6.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.61|-14.39|<0.0001
71748632|NCT03192176|143005297|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.98||0.0819|TWO_SIDED|95.0|-7.36|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.44|-7.36|0.0819
71748633|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.78|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.09|-10.78|0.0004
71748634|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.94||0.0005|TWO_SIDED|95.0|-10.69|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.05|-10.69|0.0005
71748635|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|1.98||0.038|TWO_SIDED|95.0|-8.01|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.23|-8.01|0.0380
71780878|NCT01817530|143061433|SUPERIORITY|||||||0.188||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.188
71748636|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.99||0.0002|TWO_SIDED|95.0|-11.46|-3.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-3.64|-11.46|0.0002
71748637|NCT03192176|143005297|SUPERIORITY||LSMean differencce|-8.1|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-11.96|-4.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.17|-11.96|<0.0001
71748638|NCT03192176|143005297|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-13.17|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.25|-13.17|<0.0001
71748639|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.02||0.0245|TWO_SIDED|95.0|-8.52|-0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.59|-8.52|0.0245
71748640|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.99||0.0031|TWO_SIDED|95.0|-9.83|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.01|-9.83|0.0031
71780879|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71780880|NCT01817530|143061433|SUPERIORITY|||||||0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.001
71748641|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.98||0.0046|TWO_SIDED|95.0|-9.53|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-1.75|-9.53|0.0046
71748642|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.0064|TWO_SIDED|95.0|-9.61|-1.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.59|-9.61|0.0064
71667390|NCT03105518|142850716|SUPERIORITY||1 way test, chisquare approximation|7.188||||0.007|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 0; Follicles ≤10 vs. \> 10||||0.007
71748643|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.7|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.72|-4.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.65|-12.72|<0.0001
71748644|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.78|-4.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.75|-12.78|<0.0001
71748645|NCT03192176|143005297|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.27|-6.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.09|-14.27|<0.0001
71748646|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.08||0.0021|TWO_SIDED|95.0|-10.54|-2.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.36|-10.54|0.0021
71748647|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|2.05||0.0002|TWO_SIDED|95.0|-11.71|-3.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-3.66|-11.71|0.0002
71780881|NCT01817530|143061433|SUPERIORITY|||||||0.104||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.104
71780882|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71667391|NCT03105518|142850716|SUPERIORITY||1 way Test, ChiSquare Approximation|3.6396||||0.056|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 15; Follicles ≤10 vs. \> 10||||0.056
71667392|NCT03105518|142850716|SUPERIORITY||1 way Test, ChiSquare Approximation|15.971|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 30; Follicles ≤10 vs. \> 10||||<0.0001
71748648|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.04||0.0007|TWO_SIDED|95.0|-10.96|-2.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.95|-10.96|0.0007
71748649|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.03||0.0075|TWO_SIDED|95.0|-9.46|-1.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.47|-9.46|0.0075
71748650|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.44|-4.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.42|-12.44|<0.0001
71748651|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-12.15|-4.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.16|-12.15|<0.0001
71748652|NCT03192176|143005297|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.3|-6.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-6.16|-14.30|<0.0001
71780883|NCT01817530|143061433|SUPERIORITY|||||||0.021||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.021
71780884|NCT01817530|143061433|SUPERIORITY|||||||0.859||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.859
71780885|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71780886|NCT01817530|143061433|SUPERIORITY|||||||0.006||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.006
71667393|NCT03105518|142850716|SUPERIORITY||1-way Test, ChiSquare Approximation|16.0972|||<|0.0001|TWO_SIDED||||||Kruskal-Wallis|||VAS at Time 60; Follicles ≤10 vs. \> 10||||<0.0001
71667394|NCT03105518|142850717|SUPERIORITY||1-way Test, ChiSquare Approximation|2.7205||||0.0991|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 1; Follicles ≤10 vs. \> 10||||0.0991
71667395|NCT03105518|142850717|SUPERIORITY||1 way Test, ChiSquare Approximation|1.5654||||0.2109|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 2; Follicles ≤10 vs. \> 10||||0.2109
71667396|NCT03105518|142850717|SUPERIORITY||1-way Test, ChiSquare Approximation|0.008||||0.9287|TWO_SIDED||||||Kruskal-Wallis|||VAS at Post Operative Day 3; Follicles ≤10 vs. \> 10||||0.9287
71748653|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|2.06||0.0021|TWO_SIDED|95.0|-10.46|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.34|-10.46|0.0021
71748654|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-12.25|-4.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.25|-12.25|<0.0001
71748655|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.02||0.0002|TWO_SIDED|95.0|-11.58|-3.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.62|-11.58|0.0002
71748656|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.92||0.0123|TWO_SIDED|95.0|-8.6|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.05|-8.60|0.0123
71835161|NCT01424670|143175051|SUPERIORITY||Relative Ratio of Probability|0.965||||0.5269|TWO_SIDED|95.0|0.869|1.073|||Cochran-Mantel-Haenszel|||Statistical comparison of proportions with favorable treatment outcomes assessed by the Principal Investigator.||1.073|0.869|0.5269
71667397|NCT05387889|142850718|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.054|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.054
71667398|NCT05387889|142850719|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.25|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.25
71667399|NCT05387889|142850720|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.07|TWO_SIDED|95.0||||The threshold for the level of significance is set at less than or equal to 0.05|ANCOVA|||||||< 0.07
71667400|NCT02045446|142850721|SUPERIORITY||Hazard Ratio (HR)|0.304||||0.01|TWO_SIDED|95.0|0.113|0.815|||Log Rank|||||0.815|0.113|.01
71667401|NCT02064296|142850745|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain.||||0.3330
71667402|NCT02064296|142850745|SUPERIORITY|||||||0.6474|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Healthy controls||||0.6474
71667403|NCT02064296|142850745|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Salience co-activation pattern at rest vs. with pressure pain||||<0.0001
71667404|NCT02064296|142850745|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||This statistical analysis covers the sensorimotor co-activation pattern at rest vs. with pressure pain for Fibromyalgia patients||||0.0004
71667405|NCT02064296|142850746|SUPERIORITY|||||||0.0653|||||||t-test, 2 sided|||This is a comparison of Mock Laser Acupuncture pre-and post 4 weeks of treatment.||||0.0653
71667406|NCT02064296|142850746|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||This is a P value for the change in Traditional Acupuncture, pre and post 4 weeks of treatment.||||<0.0001
71748657|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.63|-4.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.07|-11.63|<0.0001
71748658|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.92|<|0.0001|TWO_SIDED|95.0|-11.8|-4.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.23|-11.80|<0.0001
71748659|NCT03192176|143005297|SUPERIORITY||LSMean difference|-9.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-13.73|-6.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-6.03|-13.73|<0.0001
71748660|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.95||0.0013|TWO_SIDED|95.0|-10.13|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.47|-10.13|0.0013
71835162|NCT01424670|143175053|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.6986|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA|||Statistical comparison of mean AUC of change from Baseline.||1.3|-1.9|0.6986
71667407|NCT02064296|142850747|SUPERIORITY|||||||0.7399|||||||t-test, 2 sided|||Glx statistical comparison||||0.7399
71667408|NCT02064296|142850747|SUPERIORITY|||||||0.6226|||||||t-test, 2 sided|||Glx statistical comparison||||0.6226
71667409|NCT02064296|142850748|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||GABA statistical comparison||||0.6344
71667410|NCT02064296|142850748|SUPERIORITY|||||||0.7985|||||||t-test, 2 sided|||GABA statistical comparison||||0.7985
71667411|NCT03885661|142850767|SUPERIORITY|||||||0.65|||||||mixed effects regression|testing for the outcome employed mixed effects regression. The key fixed effects were group assignment, period, and the group X period interaction.||||||0.65
71835163|NCT01424670|143175054|SUPERIORITY|||||||0.6825|||||||ANCOVA|||Statistical analysis for Week 1.||||0.6825
71667412|NCT04194645|142850881|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|97.71|||||TWO_SIDED|90.0|91.45|104.4|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||104.40|91.45|
71667413|NCT04194645|142850881|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.88|||||TWO_SIDED|90.0|98.82|128.94|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.8|No formal hypothesis was tested.||128.94|98.82|
71667414|NCT04194645|142850882|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|48.02|||||TWO_SIDED|90.0|41.86|55.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 18.5|No formal hypothesis was tested.||55.09|41.86|
71667415|NCT04194645|142850882|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|122.8|||||TWO_SIDED|90.0|105.04|143.56|||ANOVA||Intra- individual coefficient of variation (gCV %) = 19.8|No formal hypothesis was tested.||143.56|105.04|
71667416|NCT04194645|142850885|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T2/R)|98.32|||||TWO_SIDED|90.0|91.98|105.09|||ANOVA||Intra- individual coefficient of variation (gCV %) = 8.9|No formal hypothesis was tested.||105.09|91.98|
71667417|NCT04194645|142850885|OTHER|The statistical model used for the analysis of the endpoint was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio of geometric mean (T1/T2)|112.94|||||TWO_SIDED|90.0|98.75|129.18|||ANOVA||Intra- individual coefficient of variation (gCV %) = 16.9|No formal hypothesis was tested.||129.18|98.75|
71667418|NCT01783886|142850886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.1|||<|0.0001|TWO_SIDED|97.5|10.9|17.2|||ANCOVA||Least Square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||17.2|10.9|<0.0001
71667419|NCT01783886|142850886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|97.5|10.2|16.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||16.9|10.2|<0.0001
71748661|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.97|-3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.41|-10.97|0.0002
71748662|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.41|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.89|-10.41|0.0006
71667420|NCT01783886|142850887|SUPERIORITY_OR_OTHER||CMH adjusted difference|47.4|||<|0.0001|TWO_SIDED|97.5|35.0|59.9|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH). The estimate is calculated as EYLEA minus Laser.|||59.9|35.0|<0.0001
71667421|NCT01783886|142850887|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.2|||<|0.0001|TWO_SIDED|97.5|26.3|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.1|26.3|<0.0001
71667422|NCT01783886|142850888|SUPERIORITY_OR_OTHER||CMH adjusted difference|31.1|||<|0.0001|TWO_SIDED|97.5|19.2|43.0|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||43.0|19.2|<0.0001
71667423|NCT01783886|142850888|SUPERIORITY_OR_OTHER||CMH adjusted difference|24.3|||<|0.0001|TWO_SIDED|97.5|12.6|35.9|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||35.9|12.6|<0.0001
71667424|NCT01783886|142850889|SUPERIORITY_OR_OTHER||CMH adjusted difference|39.1|||<|0.0001|TWO_SIDED|97.5|26.0|52.2|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||52.2|26.0|<0.0001
71667425|NCT01783886|142850889|SUPERIORITY_OR_OTHER||CMH adjusted difference|40.6|||<|0.0001|TWO_SIDED|97.5|27.6|53.7|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.|||53.7|27.6|<0.0001
71667426|NCT01783886|142850890|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-130.5|||<|0.0001|TWO_SIDED|97.5|-171.2|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-171.2|<0.0001
71748663|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0119|TWO_SIDED|95.0|-8.54|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.07|-8.54|0.0119
71748664|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.9||0.0004|TWO_SIDED|95.0|-10.58|-3.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.09|-10.58|0.0004
71835164|NCT01424670|143175054|SUPERIORITY|||||||0.807|||||||ANCOVA|||Statistical analysis for Week 2.||||0.807
71748665|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-11.57|-4.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-4.06|-11.57|<0.0001
71748666|NCT03192176|143005297|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-12.89|-5.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.27|-12.89|<0.0001
71748667|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.18|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.58|-9.18|0.0057
71748668|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.91||0.0006|TWO_SIDED|95.0|-10.4|-2.9||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.90|-10.40|0.0006
71748669|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.89||0.0006|TWO_SIDED|95.0|-10.27|-2.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.81|-10.27|0.0006
71748670|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.93||0.021|TWO_SIDED|95.0|-8.27|-0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.68|-8.27|0.0210
71667427|NCT01783886|142850890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.4|||<|0.0001|TWO_SIDED|97.5|-172.8|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||-89.9|-172.8|<0.0001
71748671|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.93||0.0002|TWO_SIDED|95.0|-10.98|-3.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.38|-10.98|0.0002
71748672|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.3|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.12|-3.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.49|-11.12|0.0002
71748673|NCT03192176|143005297|SUPERIORITY||LSMean difference|-9.1|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.99|-5.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-5.25|-12.99|<0.0001
71748674|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.96||0.0047|TWO_SIDED|95.0|-9.45|-1.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-1.73|-9.45|0.0047
71748675|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.29|-2.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.67|-10.29|0.0009
71835165|NCT01424670|143175054|SUPERIORITY|||||||0.269|||||||ANCOVA|||Statistical analysis for Week 3.||||0.269
71835166|NCT01424670|143175054|SUPERIORITY|||||||0.2333|||||||ANCOVA|||Statistical analysis for Week 24.||||0.2333
71835167|NCT01424670|143175054|SUPERIORITY|||||||0.9397|||||||ANCOVA|||Statistical analysis for Month 6.||||0.9397
71835168|NCT01424670|143175055|SUPERIORITY||Relative Ratio of Probability|0.991||||0.8951|TWO_SIDED|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with treatment success at Month 30.||1.127|0.872|0.8951
71835169|NCT02891915|143175064|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.|Pr (Higher DOOR in Short-Course)|0.69|||<|0.001|TWO_SIDED|95.0|0.63|0.75||Missing DOOR values at OAV #1 were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.75|0.63|<0.001
71835170|NCT02891915|143175065|SUPERIORITY|Testing whether Short course is superior to Standard course based on DOOR at OAV #2|Pr (Higher DOOR in Short-Course)|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.69||Missing DOOR values at OAV #2 were first imputed using linear regression using baseline covariates and available DOOR components as covariates|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value.||Null: the sum of the probability that a subject assigned to the 5-day arm will have a higher DOOR (higher DOOR is a lower numerical value and is superior) than if assigned to the 10-day arm plus one-half the probability of equal DOORs is 50% (i.e., no difference in DOOR).||0.69|0.57|<0.001
71835171|NCT00709098|143175080|SUPERIORITY_OR_OTHER||Mean group difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.0|-3.1|||t-test, 2 sided|||||-3.1|-7.0|<0.0001
71835172|NCT01091168|143175096|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.673|TWO_SIDED|95.0|0.86|1.25|||Cochran-Mantel-Haenszel|||Kaplan-Meier curves and life tables by treatment arm were provided. Confidence intervals on the median were calculated using the Brookmeyer and Crowley method. Hazard ratio and 95% confidence intervals were reported. A stratified Cox proportional model was performed to compare the two treatment arms taking into account the stratification factors (except centre) used at the time of randomisation.||1.25|0.86|0.673
71835173|NCT01091168|143175097|SUPERIORITY|||||||0.0424|||||||Log Rank|||The disease control rate (DCR) were compared in the ITT population and in the population evaluable for response between the 2 arms with a cochran Mantel Haenszel, stratified on WHO performance status at baseline, number of prior chemotherapy lines for the treatment of disease and disease measurability at Baseline.||||0.0424
71835174|NCT01091168|143175098|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4927|TWO_SIDED|95.0|0.8|1.12|||Log Rank|||PFS was compared between the 2 treatment arms by the log-rank test procedure with the 5 % significant level, stratified on the stratification factors (except study site) as specified at the time of randomisation. Os was analysed using Kaplan-Meir method and summarized with median and 95% CI of the median||1.12|0.8|0.4927
71835175|NCT04567615|143175138|SUPERIORITY||Strata adjusted difference in ORR|-2.7|||||TWO_SIDED|95.0|-10.7|5.3|||||Difference in ORR of Treatment B over ORR Treatment A|||5.3|-10.7|
71835176|NCT04567615|143175141|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR Treatment A|||1.33|0.75|
71667428|NCT01783886|142850891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78||||0.0364|TWO_SIDED|97.5|-0.41|11.97|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||11.97|-0.41|0.0364
71835177|NCT04567615|143175142|SUPERIORITY||Strata adjusted difference in ORR|-0.9|||||TWO_SIDED|95.0|-9.2|7.4|||||Difference in ORR of Treatment B over ORR Treatment A|||7.4|-9.2|
71835178|NCT04567615|143175145|SUPERIORITY||Cox proportional hazard model|1.0|||||TWO_SIDED|95.0|0.75|1.33|||||HR of Treatment B over HR of Treatment A|||1.33|0.75|
71835179|NCT04567615|143175146|SUPERIORITY||Cox proportional hazard model|1.05|||||TWO_SIDED|95.0|0.74|1.49|||||HR of Treatment B over HR of Treatment A|||1.49|0.74|
71835180|NCT02396199|143175180|SUPERIORITY||Proportion of participants|0.917||||0.006|ONE_SIDED|95.0|0.827|||One-sided test|Fisher Exact||Exact test, One-sided 95%, with lower limit (0.827)||||0.827|0.006
71835181|NCT04869982|143175219|OTHER|VE was defined as 1 minus the relative risk (RR). RR was defined as the ratio of the incidence rates of the RZV Group over the Placebo Group. The VE of RZV against HZ was to be demonstrated if the lower limit (LL) of the two-sided 95% CI of VE was above 25%.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|89.82|100.0||All p-values reported were related to the null hypothesis test VE = 0.|Poisson|The CI for VE is derived from the exact CI from RR.||To demonstrate the vaccine efficacy (VE) of RZV against HZ, the analysis considered the exact inference on the relative risk adjusted for age strata conditionally to the total number of confirmed HZ cases observed and time at risk. This method computed an exact confidence interval (CI) around the rate ratio (ratio of the event rates in the RZV Group versus Placebo Group) and accounted for the sum of the time at risk of the participants within each group.||100|89.82|<0.0001
71835182|NCT00567398|143175234|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
71835183|NCT00567398|143175234|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
71835184|NCT00567398|143175235|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
71835185|NCT00567398|143175235|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
71835186|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
71835187|NCT00567398|143175237|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
71835188|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
71835189|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
71835190|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
71835191|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
71835192|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
71835193|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
71667429|NCT01783886|142850891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.87||||0.0113|TWO_SIDED|97.5|0.8|12.94|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||12.94|0.80|0.0113
71667430|NCT01783886|142850892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.2688|TWO_SIDED|97.5|-2.9|8.53|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||8.53|-2.90|0.2688
71667431|NCT01783886|142850892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.01||||0.0009|TWO_SIDED|97.5|2.64|13.37|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.|||13.37|2.64|0.0009
71748676|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.92||0.0008|TWO_SIDED|95.0|-10.28|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.71|-10.28|0.0008
71748677|NCT03192176|143005297|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.93||0.0889|TWO_SIDED|95.0|-7.1|0.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.51|-7.10|0.0889
71748678|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.94||0.0023|TWO_SIDED|95.0|-9.76|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.13|-9.76|0.0023
71748679|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.94||0.0009|TWO_SIDED|95.0|-10.36|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.71|-10.36|0.0009
71780887|NCT01817530|143061433|SUPERIORITY|||||||0.015||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.015
71667432|NCT00825786|142850938|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.46|1.09|||Log Rank||group 2 vs. group 1 (sequential vs combined)|||1.09|0.46|0.14
71667433|NCT00825786|142850939|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.02
71667434|NCT00825786|142850940|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
71748680|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.98||0.0002|TWO_SIDED|95.0|-11.36|-3.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.58|-11.36|0.0002
71748681|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.97||0.0255|TWO_SIDED|95.0|-8.3|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-8.30|0.0255
71780888|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71780889|NCT01817530|143061433|SUPERIORITY|||||||0.007||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.007
71835194|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
71835195|NCT00567398|143175237|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
71835196|NCT00567398|143175238|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
71835197|NCT00567398|143175238|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
71835198|NCT00567398|143175238|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
71835199|NCT00567398|143175238|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
71835200|NCT00567398|143175238|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
71835201|NCT00567398|143175238|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
71667435|NCT00825786|142850941|SUPERIORITY|||||||0.6|||||||ANCOVA|||||||0.60
71667436|NCT00825786|142850942|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
71667437|NCT00825786|142850943|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
71667438|NCT00825786|142850944|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
71667439|NCT00770328|142850945|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71667440|NCT00770328|142850946|SUPERIORITY|||||||0.0114|||||||Wilcoxon (Mann-Whitney)|||||||0.0114
71667441|NCT02593110|142850950|SUPERIORITY||Mean Difference (Final Values)|-24.41||||0.1107|TWO_SIDED|95.0|-54.59|5.78|||ANCOVA|||||5.78|-54.59|0.1107
71667442|NCT02593110|142850950|SUPERIORITY||Mean Difference (Final Values)|9.78||||0.5378|TWO_SIDED|95.0|-21.84|41.39|||ANCOVA|||||41.39|-21.84|0.5378
71667443|NCT02593110|142850950|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.956|TWO_SIDED|95.0|-24.96|26.38|||ANCOVA|||||26.38|-24.96|0.9560
71667444|NCT02593110|142850951|SUPERIORITY||Mean Difference (Final Values)|31.35||||0.6121|TWO_SIDED|95.0|-92.42|155.12|||ANCOVA|||||155.12|-92.42|0.6121
71667445|NCT02593110|142850951|SUPERIORITY||Mean Difference (Final Values)|141.78||||0.0116|TWO_SIDED|95.0|33.14|250.42|||ANCOVA|||||250.42|33.14|0.0116
71667446|NCT02593110|142850951|SUPERIORITY||Mean Difference (Final Values)|-14.75||||0.8146|TWO_SIDED|95.0|-140.89|111.39|||ANCOVA|||||111.39|-140.89|0.8146
71667447|NCT02593110|142850952|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.8755|TWO_SIDED|95.0|-10.84|12.68|||ANCOVA|||||12.68|-10.84|0.8755
71667448|NCT02593110|142850952|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.7651|TWO_SIDED|95.0|-13.83|18.7|||ANCOVA|||||18.70|-13.83|0.7651
71667449|NCT02593110|142850952|SUPERIORITY||Mean Difference (Final Values)|6.88||||0.3776|TWO_SIDED|95.0|-8.65|22.41|||ANCOVA|||||22.41|-8.65|0.3776
71667450|NCT02593110|142850953|SUPERIORITY||Mean Difference (Final Values)|-8.06||||0.1782|TWO_SIDED|95.0|-19.91|3.79|||ANCOVA|||||3.79|-19.91|0.1782
71667451|NCT02593110|142850953|SUPERIORITY||Mean Difference (Final Values)|-5.27||||0.3555|TWO_SIDED|95.0|-16.61|6.07|||ANCOVA|||||6.07|-16.61|0.3555
71667452|NCT02593110|142850953|SUPERIORITY||Mean Difference (Final Values)|5.75||||0.3294|TWO_SIDED|95.0|-5.99|17.49|||ANCOVA|||||17.49|-5.99|0.3294
71835202|NCT00567398|143175239|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
71667453|NCT02593110|142850954|SUPERIORITY||Mean Difference (Final Values)|-8.72||||0.1569|TWO_SIDED|95.0|-20.91|3.47|||ANCOVA|||||3.47|-20.91|0.1569
71667454|NCT02593110|142850954|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.7692|TWO_SIDED|95.0|-16.16|12.02|||ANCOVA|||||12.02|-16.16|0.7692
71667455|NCT02593110|142850954|SUPERIORITY||Mean Difference (Final Values)|3.09||||0.6306|TWO_SIDED|95.0|-9.74|15.91|||ANCOVA|||||15.91|-9.74|0.6306
71667456|NCT02593110|142850955|SUPERIORITY||Mean Difference (Final Values)|-7.86||||0.3542|TWO_SIDED|95.0|-24.74|9.02|||ANCOVA|||||9.02|-24.74|0.3542
71667457|NCT02593110|142850955|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.9417|TWO_SIDED|95.0|-17.98|16.71|||ANCOVA|||||16.71|-17.98|0.9417
71667458|NCT02593110|142850955|SUPERIORITY||Mean Difference (Final Values)|5.45||||0.4508|TWO_SIDED|95.0|-8.96|19.86|||ANCOVA|||||19.86|-8.96|0.4508
71667459|NCT03172494|142850957|NON_INFERIORITY|Non-inferiority of insulin degludec/liraglutide versus insulin degludec was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 0.4%. Non-inferiority was investigated on the FAS.|Mean treatment difference|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.46|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment and previous oral anti-diabetic (OAD) treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by last observation carried forward (LOCF).||-0.46|-0.73|<0.0001
71667460|NCT03172494|142850957|SUPERIORITY||Mean treatment difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.49|||ANCOVA|||The change from baseline in HbA1c after 26 weeks of treatment was analysed using an ANCOVA model with treatment and previous OAD treatment as fixed factors and baseline HbA1c as covariate. Missing values were imputed by LOCF.||-0.49|-0.76|<0.0001
71667461|NCT03086551|142851048|OTHER||Effect Size - Cohen's d|0.2|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.||||
71667462|NCT03086551|142851048|OTHER||Effect Size - Cohen's d|0.69|||||TWO_SIDED||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.||||
71667463|NCT03086551|142851048|OTHER|Cohen's d effect size was calculated to compare the magnitude of change in time to complete the movement sequence from pre-baseline to post-intervention across the Active and Sham arms.|Effect Size - Cohen's d|-0.8|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|||||
71667464|NCT03086551|142851049|OTHER||Effect Size - Cohen's d|-0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
71667465|NCT03086551|142851049|OTHER||Effect Size - Cohen's d|0.5|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
71780890|NCT01817530|143061433|SUPERIORITY|||||||0.722||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.722
71667466|NCT03086551|142851049|OTHER||Effect Size - Cohen's d|-1.84|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
71748682|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.0031|TWO_SIDED|95.0|-9.63|-1.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.98|-9.63|0.0031
71748683|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|1.93||0.0037|TWO_SIDED|95.0|-9.45|-1.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.85|-9.45|0.0037
71748684|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|1.84||0.0316|TWO_SIDED|95.0|-7.59|-0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.35|-7.59|0.0316
71748685|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.84||0.0036|TWO_SIDED|95.0|-9.02|-1.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.78|-9.02|0.0036
71748686|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.85||0.0004|TWO_SIDED|95.0|-10.23|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.94|-10.23|0.0004
71748687|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.88||0.0001|TWO_SIDED|95.0|-10.93|-3.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.54|-10.93|0.0001
71748688|NCT03192176|143005297|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.87||0.0502|TWO_SIDED|95.0|-7.37|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||0.00|-7.37|0.0502
71780891|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71748689|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0025|TWO_SIDED|95.0|-9.28|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.99|-9.28|0.0025
71748690|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.84||0.0063|TWO_SIDED|95.0|-8.67|-1.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.44|-8.67|0.0063
71748691|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.9||0.0117|TWO_SIDED|95.0|-8.58|-1.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.08|-8.58|0.0117
71748692|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.91||0.0047|TWO_SIDED|95.0|-9.17|-1.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.67|-9.17|0.0047
71748693|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.92||0.0003|TWO_SIDED|95.0|-10.8|-3.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.23|-10.80|0.0003
71748694|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.94|<|0.0001|TWO_SIDED|95.0|-11.51|-3.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.86|-11.51|<0.0001
71780892|NCT01817530|143061433|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71780893|NCT01817530|143061433|SUPERIORITY|||||||0.032||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.032
71667467|NCT03086551|142851049|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.||||
71748695|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.94||0.0083|TWO_SIDED|95.0|-8.97|-1.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.34|-8.97|0.0083
71748696|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.92||0.0011|TWO_SIDED|95.0|-10.1|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.56|-10.10|0.0011
71748697|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.9||0.0017|TWO_SIDED|95.0|-9.77|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.29|-9.77|0.0017
71748698|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.86||0.0119|TWO_SIDED|95.0|-8.37|-1.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.05|-8.37|0.0119
71748699|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.29|-9.61|0.0015
71748700|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.38|-3.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.99|-11.38|<0.0001
71748701|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-11.33|-3.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.87|-11.33|<0.0001
71780894|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71780895|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71748702|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.89||0.0051|TWO_SIDED|95.0|-9.07|-1.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.62|-9.07|0.0051
71748703|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.87||0.0004|TWO_SIDED|95.0|-10.33|-2.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.96|-10.33|0.0004
71748704|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0014|TWO_SIDED|95.0|-9.64|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.34|-9.64|0.0014
71748705|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.1|STANDARD_ERROR_OF_MEAN|1.82||0.0054|TWO_SIDED|95.0|-8.67|-1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.51|-8.67|0.0054
71748706|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.55|-9.71|0.0008
71748707|NCT03192176|143005297|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.2|-3.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.97|-11.20|<0.0001
71780896|NCT01817530|143061434|SUPERIORITY|||||||0.041||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.041
71780897|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71667468|NCT03086551|142851049|OTHER||Effect Size - Cohen's d|0.08|||||TWO_SIDED||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.||||
71748708|NCT03192176|143005297|SUPERIORITY||LSMean difference|-8.2|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-11.88|-4.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.59|-11.88|<0.0001
71780898|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||< 0.001
71748709|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.85||0.0026|TWO_SIDED|95.0|-9.27|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-1.99|-9.27|0.0026
71748710|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.83||0.0003|TWO_SIDED|95.0|-10.35|-3.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.16|-10.35|0.0003
71748711|NCT03192176|143005297|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|1.81||0.0006|TWO_SIDED|95.0|-9.88|-2.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.75|-9.88|0.0006
71748712|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.12||0.0126|TWO_SIDED|95.0|-9.48|-1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.15|-9.48|0.0126
71748713|NCT03192176|143005297|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|2.12||0.1724|TWO_SIDED|95.0|-7.06|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||1.27|-7.06|0.1724
71748714|NCT03192176|143005297|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.18||0.3548|TWO_SIDED|95.0|-6.31|2.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||2.27|-6.31|0.3548
71780899|NCT01817530|143061434|SUPERIORITY|||||||0.008||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 3||||0.008
71748715|NCT03192176|143005297|SUPERIORITY||LSMean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.18||0.086|TWO_SIDED|95.0|-8.04|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.53|-8.04|0.0860
71748716|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.19||0.0111|TWO_SIDED|95.0|-9.89|-1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.28|-9.89|0.0111
71748717|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.19||0.0349|TWO_SIDED|95.0|-8.94|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.33|-8.94|0.0349
71780900|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71780901|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71748718|NCT03192176|143005297|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.12||0.2205|TWO_SIDED|95.0|-6.77|1.57||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.57|-6.77|0.2205
71780902|NCT01817530|143061434|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
71780903|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71780904|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||< 0.001
71667469|NCT03086551|142851049|OTHER||Effect Size - Cohen's d|0.38|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.||||
71667470|NCT03086551|142851050|OTHER||Effect Size - Cohen's d|-0.86|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71748719|NCT03192176|143005297|SUPERIORITY||LSMean differencce|-4.0|STANDARD_ERROR_OF_MEAN|2.17||0.0645|TWO_SIDED|95.0|-8.29|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||0.24|-8.29|0.0645
71667471|NCT03086551|142851050|OTHER||Effect Size - Cohen's d|-0.04|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71748720|NCT03192176|143005297|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.16||0.5031|TWO_SIDED|95.0|-5.69|2.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.80|-5.69|0.5031
71748721|NCT03192176|143005297|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|2.24||0.5263|TWO_SIDED|95.0|-5.84|2.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.99|-5.84|0.5263
71748722|NCT03192176|143005297|SUPERIORITY||LSMean differencce|-2.4|STANDARD_ERROR_OF_MEAN|2.24||0.2782|TWO_SIDED|95.0|-6.83|1.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.97|-6.83|0.2782
71748723|NCT03192176|143005297|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|2.24||0.0198|TWO_SIDED|95.0|-9.67|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.84|-9.67|0.0198
71835203|NCT00567398|143175239|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
71667472|NCT03086551|142851050|OTHER||Effect Size - Cohen's d|-0.69|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71748724|NCT03192176|143005297|SUPERIORITY||LSMean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.25||0.0417|TWO_SIDED|95.0|-9.05|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.18|-9.05|0.0417
71748725|NCT03192176|143005297|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.16||0.2963|TWO_SIDED|95.0|-6.52|2.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.00|-6.52|0.2963
71835204|NCT00567398|143175239|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
71748726|NCT03192176|143005297|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|2.09||0.5408|TWO_SIDED|95.0|-5.39|2.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.83|-5.39|0.5408
71748727|NCT03192176|143005297|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|2.07||0.7473|TWO_SIDED|95.0|-4.74|3.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.41|-4.74|0.7473
71835205|NCT00567398|143175239|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
71835206|NCT00567398|143175240|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
71748728|NCT03192176|143005297|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|2.18||0.9214|TWO_SIDED|95.0|-4.07|4.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.50|-4.07|0.9214
71748729|NCT03192176|143005297|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.14||0.9876|TWO_SIDED|95.0|-4.19|4.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.26|-4.19|0.9876
71748730|NCT03192176|143005297|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.18||0.2379|TWO_SIDED|95.0|-6.86|1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.71|-6.86|0.2379
71780905|NCT01817530|143061434|SUPERIORITY|||||||0.003||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||||0.003
71667473|NCT03086551|142851050|OTHER||Effect Size - Cohen's d|0.28|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.||||
71748731|NCT03192176|143005297|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|2.18||0.1491|TWO_SIDED|95.0|-7.45|1.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.14|-7.45|0.1491
71748732|NCT03192176|143005297|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|2.07||0.956|TWO_SIDED|95.0|-3.96|4.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.19|-3.96|0.9560
71748733|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.96||0.0089|TWO_SIDED|95.0|-9.01|-1.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-1.30|-9.01|0.0089
71748734|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|-12.22|-4.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-4.48|-12.22|<0.0001
71780906|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71748735|NCT03192176|143005298|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.06|-5.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-5.34|-13.06|<0.0001
71748736|NCT03192176|143005298|SUPERIORITY||LSMean difference|-10.7|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-14.58|-6.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-6.75|-14.58|<0.0001
71748737|NCT03192176|143005298|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|2.0||0.063|TWO_SIDED|95.0|-7.65|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||0.20|-7.65|0.0630
71748738|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.04|-3.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-3.30|-11.04|0.0003
71748739|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.96||0.0007|TWO_SIDED|95.0|-10.53|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 1||-2.84|-10.53|0.0007
71748740|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.98||0.0231|TWO_SIDED|95.0|-8.43|-0.63||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.63|-8.43|0.0231
71780907|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71780908|NCT01817530|143061434|SUPERIORITY|||||||0.004||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.004
71748741|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.94|-4.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.09|-11.94|<0.0001
71748742|NCT03192176|143005298|SUPERIORITY||LSMean differencce|-8.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.0001|TWO_SIDED|95.0|-11.87|-4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-4.05|-11.87|<0.0001
71748743|NCT03192176|143005298|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-13.21|-5.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-5.26|-13.21|<0.0001
71748744|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|2.02||0.0177|TWO_SIDED|95.0|-8.8|-0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-0.84|-8.80|0.0177
71780909|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71780910|NCT01817530|143061434|SUPERIORITY||||||<|0.001||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||< 0.001
71780911|NCT01817530|143061434|SUPERIORITY|||||||0.002||||||P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Final Visit||||0.002
71748745|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.99||0.0012|TWO_SIDED|95.0|-10.45|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.60|-10.45|0.0012
71748746|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0072|TWO_SIDED|95.0|-9.26|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 2||-2.64|-9.26|0.0072
71748747|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|2.04||0.0044|TWO_SIDED|95.0|-9.86|-1.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-1.84|-9.86|0.0044
71748748|NCT03192176|143005298|SUPERIORITY||LSMean difference|-9.2|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-13.27|-5.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-5.21|-13.27|<0.0001
71780912|NCT01817530|143061435|SUPERIORITY||difference in LS means|-1.5|STANDARD_ERROR_OF_MEAN|2.58||0.556|TWO_SIDED|95.0|-6.65|3.59||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||3.59|-6.65|0.556
71780913|NCT01817530|143061435|SUPERIORITY||difference in LS means|-1.1|STANDARD_ERROR_OF_MEAN|2.63||0.672|TWO_SIDED|95.0|-6.33|4.09||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||4.09|-6.33|0.672
71748749|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.6|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.57|-4.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.55|-12.57|<0.0001
71748750|NCT03192176|143005298|SUPERIORITY||LSMean difference|-10.2|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.29|-6.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-6.11|-14.29|<0.0001
71748751|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|2.08||0.0009|TWO_SIDED|95.0|-11.04|-2.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.87|-11.04|0.0009
71780914|NCT01817530|143061435|SUPERIORITY||difference in LS means|3.0|STANDARD_ERROR_OF_MEAN|2.71||0.274|TWO_SIDED|95.0|-2.39|8.36||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||8.36|-2.39|0.274
71780915|NCT01817530|143061435|SUPERIORITY||difference in LS means|-2.0|STANDARD_ERROR_OF_MEAN|1.65||0.223|TWO_SIDED|95.0|-5.26|1.23||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.23|-5.26|0.223
71667474|NCT03086551|142851051|OTHER||Effect Size - Cohen's d|-0.31|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71748752|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-12.44|-4.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-4.39|-12.44|<0.0001
71748753|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|2.04||0.0012|TWO_SIDED|95.0|-10.65|-2.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 3||-2.64|-10.65|0.0012
71780916|NCT01817530|143061435|SUPERIORITY||difference in LS means|-2.1|STANDARD_ERROR_OF_MEAN|1.68||0.215|TWO_SIDED|95.0|-5.38|1.22||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.22|-5.38|0.215
71835207|NCT00567398|143175240|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
71667475|NCT03086551|142851051|OTHER||Effect Size - Cohen's d|-0.85|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71667476|NCT03086551|142851051|OTHER||Effect Size - Cohen's d|-0.35|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71667477|NCT03086551|142851051|OTHER||Effect Size - Cohen's d|1.13|||||TWO_SIDED||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.||||
71667478|NCT03086551|142851052|OTHER||Effect Size - Cohen's d|-0.15|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
71667479|NCT03086551|142851052|OTHER||Effect Size - Cohen's d|-1.46|||||TWO_SIDED||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.||||
71667480|NCT02201277|142851053|SUPERIORITY|||||||1|||||||t-test, 2 sided|||A Fisher's exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.||||1.0
71667481|NCT02201277|142851053|EQUIVALENCE|rate of penetration||||||1|||||||t-test, 1 sided|||||||1.0
71748754|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.04||0.0053|TWO_SIDED|95.0|-9.72|-1.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-1.71|-9.72|0.0053
71667482|NCT01512160|142851061|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.3|2.2||||||Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.||2.2|-4.3|
71667483|NCT01512160|142851061|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-4.1|2.3||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||2.3|-4.1|
71667484|NCT01512160|142851061|SUPERIORITY_OR_OTHER||LS mean difference|3.5|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|0.3|6.7||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.||6.7|0.3|
71780917|NCT01817530|143061435|SUPERIORITY||difference in LS means|-1.4|STANDARD_ERROR_OF_MEAN|1.68||0.392|TWO_SIDED|95.0|-4.75|1.87||P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.|ANCOVA|||Final Month||1.87|-4.75|0.392
71667485|NCT01512160|142851065|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.8|1.9||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||1.9|-2.8|
71667486|NCT01512160|142851065|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-2.7|2.0||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||2.0|-2.7|
71667487|NCT01512160|142851065|SUPERIORITY_OR_OTHER||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|0.4|5.1||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||5.1|0.4|
71667488|NCT01512160|142851065|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-12.6|10.5||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||10.5|-12.6|
71835208|NCT00567398|143175241|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
71835209|NCT00567398|143175242|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
71748755|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.77|-4.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.73|-12.77|<0.0001
71748756|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.8|STANDARD_ERROR_OF_MEAN|2.04||0.0001|TWO_SIDED|95.0|-11.84|-3.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.84|-11.84|0.0001
71748757|NCT03192176|143005298|SUPERIORITY||LSMean difference|-10.0|STANDARD_ERROR_OF_MEAN|2.07|<|0.0001|TWO_SIDED|95.0|-14.12|-5.96||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-5.96|-14.12|<0.0001
71748758|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|2.07||0.001|TWO_SIDED|95.0|-10.92|-2.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-2.78|-10.92|0.0010
71748759|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-12.49|-4.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-4.46|-12.49|<0.0001
71748760|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.03||0.0005|TWO_SIDED|95.0|-11.12|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-3.13|-11.12|0.0005
71748761|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.4|STANDARD_ERROR_OF_MEAN|1.93||0.0057|TWO_SIDED|95.0|-9.15|-1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-1.58|-9.15|0.0057
71748762|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.4|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-12.15|-4.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.56|-12.15|<0.0001
71748763|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.68|-4.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-4.08|-11.68|<0.0001
71748764|NCT03192176|143005298|SUPERIORITY||LSMean difference|-9.8|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-13.66|-5.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-5.93|-13.66|<0.0001
71748765|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|1.95||0.0007|TWO_SIDED|95.0|-10.54|-2.85||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.85|-10.54|0.0007
71748766|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.7|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-11.55|-3.95||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-3.95|-11.55|<0.0001
71748767|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.92||0.001|TWO_SIDED|95.0|-10.16|-2.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 5||-2.60|-10.16|0.0010
71748768|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.91||0.0064|TWO_SIDED|95.0|-8.99|-1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.48|-8.99|0.0064
71748769|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.91||0.0002|TWO_SIDED|95.0|-10.94|-3.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.42|-10.94|0.0002
71748770|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.92||0.0001|TWO_SIDED|95.0|-11.29|-3.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.75|-11.29|0.0001
71748771|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.95|<|0.0001|TWO_SIDED|95.0|-12.69|-5.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-5.03|-12.69|<0.0001
71667489|NCT01512160|142851065|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|90.0|-11.5|11.4||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||11.4|-11.5|
71667490|NCT01512160|142851065|SUPERIORITY_OR_OTHER||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|7.0|||TWO_SIDED|90.0|-4.0|19.1||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||19.1|-4.0|
71667491|NCT01512160|142851066|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-15.6|16.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||16.1|-15.6|
71667492|NCT01512160|142851066|SUPERIORITY_OR_OTHER||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|-16.5|14.8||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||14.8|-16.5|
71667493|NCT01512160|142851066|SUPERIORITY_OR_OTHER||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|90.0|-6.6|25.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||25.1|-6.6|
71667494|NCT01512160|142851067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.5|
71667495|NCT01512160|142851067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|90.0|0.7|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.7|
71667496|NCT01512160|142851067|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.6|2.0||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.0|0.6|
71667497|NCT01512160|142851068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.5|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.1|0.5|
71667498|NCT01512160|142851068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.4|1.8||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.8|0.4|
71667499|NCT01512160|142851068|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|90.0|0.7|2.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.9|0.7|
71667500|NCT01512160|142851069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.6|
71667501|NCT01512160|142851069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.7|2.4||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|0.7|
71667502|NCT01512160|142851069|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|90.0|0.4|1.3||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.3|0.4|
71677046|NCT00688662|142872539|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.6||||0.01|TWO_SIDED|95.0|-28.0|-3.3||The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.|Regression, Logistic|Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.|The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).|The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome ('success') in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O'Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.||-3.3|-28.0|0.01
71677047|NCT00688662|142872540|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.0|||||TWO_SIDED|95.0|-24.1|5.9||A confidence interval approach was used for examining this outcome.||||Only patients with abnormal manometry were included in this subgroup analysis.||5.9|-24.1|
71677048|NCT00746564|142872542|SUPERIORITY_OR_OTHER||percentage of recordings|100.0|||||TWO_SIDED|95.0|100.0|100.0||||||"The sensitivity was calculated for each recording and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|100|
71780918|NCT03298867|143061437|SUPERIORITY||Stratified difference in percentages|73.45|STANDARD_ERROR_OF_MEAN|7.43|<|0.001|TWO_SIDED|95.0|58.89|88.01||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||88.01|58.89|<0.001
71780919|NCT03298867|143061438|SUPERIORITY||Stratified difference in percentages|70.82|STANDARD_ERROR_OF_MEAN|7.62|<|0.001|TWO_SIDED|95.0|55.89|85.75||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||85.75|55.89|<0.001
71780920|NCT03298867|143061439|SUPERIORITY||Stratified difference in percentages|36.03|STANDARD_ERROR_OF_MEAN|9.51|<|0.001|TWO_SIDED|95.0|17.39|54.67||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||54.67|17.39|<0.001
71667503|NCT04205812|142851092|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0042|TWO_SIDED|95.0|0.6|0.93||The p-value was based on a stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis.|Log Rank||A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.93|0.60|0.0042
71667504|NCT04205812|142851093|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Log Rank|The p-value was based on the stratified log-rank test for PFS.|A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.|||0.79|0.52|<0.0001
71748772|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.94||0.003|TWO_SIDED|95.0|-9.62|-1.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-1.99|-9.62|0.0030
71748773|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.92||0.0002|TWO_SIDED|95.0|-10.92|-3.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-3.37|-10.92|0.0002
71748774|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.9||0.0013|TWO_SIDED|95.0|-9.91|-2.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 6||-2.42|-9.91|0.0013
71748775|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|1.94||0.0137|TWO_SIDED|95.0|-8.61|-0.99||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-0.99|-8.61|0.0137
71748776|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.94||0.0002|TWO_SIDED|95.0|-11.24|-3.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.60|-11.24|0.0002
71748777|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.95||0.0004|TWO_SIDED|95.0|-10.79|-3.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-3.13|-10.79|0.0004
71780921|NCT03298867|143061440|SUPERIORITY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|0.244|<|0.001|TWO_SIDED|95.0|-2.77|-1.8||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||-1.80|-2.77|<0.001
71667505|NCT04205812|142851094|SUPERIORITY|||||||0.0012||||||The p-value was calculated at the 1-sided 2.5% level from stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|||||||0.0012
71677049|NCT00746564|142872543|SUPERIORITY_OR_OTHER||percentage of clinical recordings|98.1|||||TWO_SIDED|95.0|95.7|100.0||||||"The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.7|
71748778|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.9|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-12.74|-4.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-4.97|-12.74|<0.0001
71748779|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.9|STANDARD_ERROR_OF_MEAN|1.97||0.0028|TWO_SIDED|95.0|-9.82|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.07|-9.82|0.0028
71748780|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.95||0.0006|TWO_SIDED|95.0|-10.6|-2.94||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.94|-10.60|0.0006
71748781|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.93||0.002|TWO_SIDED|95.0|-9.82|-2.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 7||-2.21|-9.82|0.0020
71748782|NCT03192176|143005298|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0588|TWO_SIDED|95.0|-7.46|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-7.46|0.0588
71835210|NCT00567398|143175242|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
71835211|NCT00567398|143175242|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
71835212|NCT00567398|143175242|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
71835213|NCT00567398|143175243|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
71667506|NCT06473519|142851109|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1month after vaccination. Null hypotheses(H0): RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided95%CI for GMT ratios (MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV A||1.10|0.84|
71667507|NCT06473519|142851109|NON_INFERIORITY|Noninferiority of immune responses induced by MDVRSV preF compared to SDVRSV preF, assessed for RSVA\&B at 1 month after vaccination. Null hypotheses(H0):RSVA(H0A)=ln(μMDV)-ln(μSDV)\<=-ln(1.5);RSVB(H0B):ln(μMDV)-ln(μSDV)\<=-ln(1.5), where ln(μMDV)\&ln(μSDV) are means of natural log-transformed antibody concentrations 1 month after vaccination for MDV and SDV groups, respectively. Noninferiority=if lower bounds of 2-sided 95%CI for GMT ratios(MDV/SDV) were \>0.67(noninferiority margin=1.5)for RSVA\&B.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.79|1.06|||||GMR was calculated as group mean difference of logarithmically transformed antibody levels, back transformed to original units.|RSV B||1.06|0.79|
71667508|NCT02514447|142851132|SUPERIORITY||||||<|0.0001||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|non-parametric ANCOVA|Hochberg-based gatekeeping procedure||Analysis was for Part 2 data: Treatment difference was evaluated using a nonparametric analysis of covariance (ANCOVA). The nonparametric ANCOVA included study baseline ANC value as covariate, stratification factors of ECOG performance status (0 to 1 versus 2) and sensitivity to first line treatment (sensitive or resistant) and treatment as fixed effects.||||<0.0001
71667509|NCT02514447|142851133|SUPERIORITY|||||||0.016||||||A Hochberg-based gatekeeping procedure was used to control the global familywise error rate across the multiple null hypotheses (primary and key secondary myelosuppression efficacy endpoints) in a strong sense at a 1-sided 0.10 level.|Modified Poisson|Hochberg-based gatekeeping procedure||The occurrence of SN was a binary variable. Treatment group difference was analyzed using modified Poisson regression to account for the variable duration of the Treatment Period for each patient. The model included baseline ANC as a covariate, stratification factors of ECOG performance status (0 or 1 vs 2), sensitivity to 1st line treatment (sensitive or resistant), and treatment as fixed effects. The logarithm transformation of # of cycles was included as an offset variable in the modeling.||||0.0160
71667510|NCT04776148|142851167|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).|Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|95.0|0.56|0.85||One-sided p-value based on log-rank test stratified by presence of liver metastasis|Log Rank|||||0.85|0.56|0.0003
71667511|NCT04776148|142851168|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|1.15||||0.7421|TWO_SIDED|85.0|0.75|1.77||One-sided p-value based on log-rank test.|Log Rank|||||1.77|0.75|0.7421
71667512|NCT04776148|142851169|OTHER||Difference in Percentage vs. SOC|8.7|||<|0.0001|TWO_SIDED|95.0|4.7|13.5|||Chi-squared||Based on Miettinen \& Nurminen method stratified by presence of liver metastasis|||13.5|4.7|<0.0001
71667513|NCT04776148|142851170|OTHER||Difference in Percentage vs. SOC|3.3||||0.2456|TWO_SIDED|95.0|-7.7|14.3|||Chi-squared||Based on Miettinen \& Nurminen method.|||14.3|-7.7|0.2456
71667514|NCT04776148|142851177|OTHER||Difference in least squares means|2.71||||0.1553|TWO_SIDED|95.0|-1.03|6.46||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||6.46|-1.03|0.1553
71667515|NCT04776148|142851178|OTHER||Difference in LS means|1.16||||0.4967|TWO_SIDED|95.0|-2.19|4.51||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||4.51|-2.19|0.4967
71667516|NCT04776148|142851179|OTHER||Difference in LS means|3.36||||0.2271|TWO_SIDED|95.0|-2.1|8.82||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||8.82|-2.10|0.2271
71667517|NCT04776148|142851180|OTHER||Difference in LS means|-5.46||||0.0264|TWO_SIDED|95.0|-10.27|-0.65||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction and stratification factor presence of liver metastasis (Yes/No).|cLDA model|||||-0.65|-10.27|0.0264
71667518|NCT04776148|142851181|OTHER||Hazard Ratio (HR)|0.91||||0.4338|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.14|0.73|0.4338
71667519|NCT04776148|142851182|OTHER||Hazard Ratio (HR)|1.1||||0.4316|TWO_SIDED|95.0|0.87|1.38||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.38|0.87|0.4316
71667520|NCT04776148|142851183|OTHER||Hazard Ratio (HR)|1.06||||0.5587|TWO_SIDED|95.0|0.85|1.32|||Regression, Cox|Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).||||1.32|0.85|0.5587
71667521|NCT04776148|142851184|OTHER||Hazard Ratio (HR)|0.95||||0.6794|TWO_SIDED|95.0|0.73|1.23||Two-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|Regression, Cox|||||1.23|0.73|0.6794
71667522|NCT04776148|142851185|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0379|TWO_SIDED|95.0|0.68|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by presence of liver metastasis (Yes/No).|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by presence of liver metastasis (Yes/No).||1.02|0.68|0.0379
71667523|NCT04776148|142851186|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3574|TWO_SIDED|95.0|0.6|1.42|||Log Rank|One-sided p-value based on log-rank test.|HR=Lenvatinib + pembrolizumab vs. SOC treatment|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.||1.42|0.60|0.3574
71891476|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.106|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.206|0.106|<0.0001
71748783|NCT03192176|143005298|SUPERIORITY||LSMean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.93||0.0018|TWO_SIDED|95.0|-9.9|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.14|-9.90|0.0018
71891477|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.025||0.698|TWO_SIDED|95.0|-0.06|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.040|-0.060|0.6980
71891478|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.233|0.132|<0.0001
71891479|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.026||0.0442|TWO_SIDED|95.0|0.001|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.102|0.001|0.0442
71891480|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.026||0.5514|TWO_SIDED|95.0|-0.035|0.065||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.065|-0.035|0.5514
71891481|NCT01431287|143304562|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1569|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.086|-0.014|0.1569
71891482|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.15|0.253||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.253|0.150|<0.0001
71891483|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
71891484|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.218|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.167|0.269||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.269|0.167|<0.0001
71891485|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.181|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.13|0.232||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day\^interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.232|0.130|<0.0001
71891486|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.199|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.148|0.25||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.250|0.148|<0.0001
71891487|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.016|STANDARD_ERROR_OF_MEAN|0.026||0.5373|TWO_SIDED|95.0|-0.067|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.035|-0.067|0.5373
71891488|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.165|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.216||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.216|0.114|<0.0001
71667524|NCT03367572|142851187|SUPERIORITY||Mean Difference (Net)|0.7056||||0.008|TWO_SIDED||||||ANOVA|||||||0.008
71667525|NCT03367572|142851187|SUPERIORITY||Mean Difference (Net)|1.1486|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71667526|NCT03367572|142851188|SUPERIORITY||Mean Difference (Net)|0.4468||||0.01|TWO_SIDED||||||ANOVA|||||||0.010
71667527|NCT03367572|142851188|SUPERIORITY||Mean Difference (Net)|0.5632||||0.001|TWO_SIDED||||||ANOVA|||||||0.001
71748784|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|1.94||0.0017|TWO_SIDED|95.0|-9.98|-2.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.34|-9.98|0.0017
71748785|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.97||0.0003|TWO_SIDED|95.0|-11.09|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-3.32|-11.09|0.0003
71748786|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.97||0.081|TWO_SIDED|95.0|-8.55|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.81|-8.55|0.0810
71748787|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.94||0.002|TWO_SIDED|95.0|-9.88|-2.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-2.23|-9.88|0.0020
71748788|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.93||0.0076|TWO_SIDED|95.0|-8.98|-1.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-1.39|-8.98|0.0076
71748789|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.85||0.0182|TWO_SIDED|95.0|-8.01|-0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.75|-8.01|0.0182
71748790|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.84||0.0019|TWO_SIDED|95.0|-9.42|-2.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.16|-9.42|0.0019
71667528|NCT03367572|142851189|SUPERIORITY||Mean Difference (Net)|-0.59||||0.019|TWO_SIDED||||||t-test, 2 sided|||"Secondary Aim 1 is to determine if olanzapine is more effective than prochlorperazine in controlling nausea at Cycle 2 in participants who experienced CINV at Cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.~This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean, and testing whether D = 0 versus the one-sided alternative hypothesis that D \> 0."||||0.019
71667529|NCT03367572|142851190|SUPERIORITY||Odds Ratio (OR)|1.31||||0.386|TWO_SIDED|97.5|0.65|2.66||prochlorperazine arm statistics|Regression, Logistic|||||2.66|0.65|0.386
71748791|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.02|-2.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.71|-10.02|0.0007
71748792|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.1|STANDARD_ERROR_OF_MEAN|1.88||0.0002|TWO_SIDED|95.0|-10.76|-3.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-3.35|-10.76|0.0002
71748793|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.88||0.0263|TWO_SIDED|95.0|-7.89|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-0.50|-7.89|0.0263
71748794|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.86||0.0015|TWO_SIDED|95.0|-9.61|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-2.29|-9.61|0.0015
71748795|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.84||0.0113|TWO_SIDED|95.0|-8.32|-1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 9||-1.07|-8.32|0.0113
71748796|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.91||0.0059|TWO_SIDED|95.0|-9.04|-1.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-1.54|-9.04|0.0059
71835214|NCT00567398|143175243|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
71667530|NCT03367572|142851190|SUPERIORITY||Odds Ratio (OR)|0.16||||0.036|TWO_SIDED|97.5|0.02|1.13||olanzapine arm statistics|Regression, Logistic|||||1.13|0.02|0.036
71835215|NCT00567398|143175243|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
71835216|NCT00567398|143175243|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
71677050|NCT00746564|142872544|SUPERIORITY_OR_OTHER||percentage of recordings|98.0|||||TWO_SIDED|95.0|95.5|100.0||||||"The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"||100|95.5|
71677051|NCT00746564|142872545|SUPERIORITY_OR_OTHER||percentage of recordings|98.9|||||TWO_SIDED|95.0|96.7|100.0||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||100|96.7|
71835217|NCT00567398|143175244|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
71835218|NCT00567398|143175244|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
71835219|NCT00567398|143175245|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
71835220|NCT00567398|143175245|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
71835221|NCT00567398|143175246|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
71835222|NCT00567398|143175246|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
71835223|NCT00567398|143175247|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
71835224|NCT00567398|143175248|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
71835225|NCT00567398|143175248|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
71835226|NCT00567398|143175248|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
71835227|NCT00567398|143175248|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
71835228|NCT00567398|143175249|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
71835229|NCT00567398|143175249|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
71835230|NCT00567398|143175250|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
71835231|NCT00567398|143175250|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
71835232|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
71835233|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
71835234|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
71835235|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
71835236|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
71835237|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
71835238|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
71835239|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
71835240|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
71835241|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
71835242|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
71835243|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
71667531|NCT04995029|142851228|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|2.62||||0.4819|TWO_SIDED|95.0|-4.69|9.93||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Cochran-Mantel-Haenszel|Difference between DB treatment arms was compared using CMH test accounting for randomization stratification.||"Based on Phase 3 results, for the primary efficacy endpoint of INDV-6000-401, a sample size of 195 per arm was estimated to provide approximately 90% power at 2-sided 0.05 alpha level to detect a difference of 15.6%.~Since the participant population in this study had more severe OUD compared with the Phase 3 DB study, the responder rates and treatment differences were anticipated to be lower."||9.93|-4.69|0.4819
71667532|NCT04995029|142851228|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|12.24|||||TWO_SIDED|95.0|2.35|22.12|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority 300-mg dose to 100-mg dose=99.099%.|22.12|2.35|
71667533|NCT04995029|142851228|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|11.06|||||TWO_SIDED|95.0|0.36|21.56|||||CMH weighted treatment difference and P-value based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=97.846%|21.56|0.36|
71667534|NCT04995029|142851228|SUPERIORITY|Any missed or skipped visit was counted as non-negative or de-facto positive. Difference between DB treatment arms was compared using CMH test accounting for randomization stratification (Opioid injection: Yes/No, Week 6 UDS Fentanyl result: Positive/Negative). Statistical superiority was declared if CMH weighted difference in proportion of responders in the 300-mg arm minus the proportion of responders in the 100-mg arm was \>0 and the 2-sided P-value of CMH test ≤0.05.|CMH treatment difference|15.37|||||TWO_SIDED|95.0|4.61|26.09|||||CMH weighted treatment difference based on CMH randomization stratified analysis using Sato (1989) variance equation. Treatment difference estimate calculated as weighted average of strata-specific estimates within each analysis stratum.|Post-hoc subgroup analyses of the primary endpoint to characterize the population of patients who would benefit from the higher maintenance dosing regimen identified participants who reported using fentanyl ≥14 times per week AND daily at Screening as one such group.|The posterior possibility of responder rate difference (300 mg-100 mg) \>0 was estimated (via Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual treatment groups) to evaluate the superiority of 300 mg over 100 mg. Bayesian posterior probability of superiority of 300-mg dose to 100-mg dose=99.675%.|26.09|4.61|
71677052|NCT00746564|142872546|SUPERIORITY_OR_OTHER||percentage of recording|77.1|||||TWO_SIDED|95.0|65.9|88.4||||||"The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||88.4|65.9|
71835244|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
71835245|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
71835246|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
71835247|NCT00567398|143175251|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
71835248|NCT00567398|143175252|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
71667535|NCT04995029|142851229|NON_INFERIORITY|Estimated by Bayesian beta-binomial model using non-informative uniform prior, ie, Beta (1,1), within individual induction arms. Posterior distribution of retention rate difference between arms was used to calculate posterior probability of NI of RI to SoC induction using a 10% NI margin or favorable trend of RI over SoC induction.|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability of RI NI to SoC, ie, (RI - SoC)\>10%=100.00%|"Null and alternative statistical hypotheses:~H0: retention rate of RI - SoC induction≤-10% (non-inferiority \[NI\] margin of 10%) HA: retention rate of RI-SoC induction\>-10%. Criterion for success (ie, demonstrating non-inferiority \[NI\]) was based on posterior probability of retention rate difference (RI-SoC)\>-10%. NI of RI to SoC induction was declared if the posterior probability was higher than 96%. The 96% critical value was chosen so that the overall 1-sided Type I error was less than 10%."||19.03|4.34|
71667536|NCT04995029|142851229|SUPERIORITY|The posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction|Bayesian beta-binomial model|11.82|||||TWO_SIDED|95.0|4.34|19.03|||||Posterior probability that RI treatment is superior to SoC treatment=99.90%|If the non-inferiority of rapid induction (RI) to standard of care (SoC) induction was declared, the posterior possibility of retention rate difference (RI - SoC) greater than 0 was estimated to evaluate the superiority of RI over SoC induction.||19.03|4.34|
71667537|NCT04995029|142851230|SUPERIORITY|A Wilcoxon rank sum test (Van Elteren 1960) stratified for randomisation factors was performed to compare the difference between the 2 treatment arms. The test result P-value was used inferentially, if the primary endpoint test was statistically significant.|Mean Difference (Net)|-1.73||||0.8836|TWO_SIDED|95.0|-6.83|3.36|||Wilcoxon rank sum (Van Elteren)|Wilcoxon rank sum test stratified by DB randomisation factor (Van Elteren, 1960).|Van Elteren Test Z-Score for Difference Between Arms (300 mg - 100 mg)=-0.1464|||3.36|-6.83|0.8836
71677053|NCT00746564|142872547|SUPERIORITY_OR_OTHER||Percentage of recordings|85.0|||||TWO_SIDED|95.0|78.3|91.7||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"||91.7|78.3|
71748797|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|1.91||0.0018|TWO_SIDED|95.0|-9.76|-2.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.25|-9.76|0.0018
71748798|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.8|STANDARD_ERROR_OF_MEAN|1.93||0.0004|TWO_SIDED|95.0|-10.62|-3.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.05|-10.62|0.0004
71748799|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.6|STANDARD_ERROR_OF_MEAN|1.95||0.0001|TWO_SIDED|95.0|-11.39|-3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-3.73|-11.39|0.0001
71748800|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.94||0.0044|TWO_SIDED|95.0|-9.4|-1.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 10||-1.75|-9.40|0.0044
71748801|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.6|STANDARD_ERROR_OF_MEAN|1.92||0.0006|TWO_SIDED|95.0|-10.4|-2.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.84|-10.40|0.0006
71748802|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.91||0.0025|TWO_SIDED|95.0|-9.57|-2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 10||-2.07|-9.57|0.0025
71780922|NCT03298867|143061441|SUPERIORITY||Stratified difference in percentages|39.29|STANDARD_ERROR_OF_MEAN|12.11||0.001|TWO_SIDED|95.0|15.55|63.02||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.|||63.02|15.55|0.001
71748803|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.2|STANDARD_ERROR_OF_MEAN|1.86||0.0059|TWO_SIDED|95.0|-8.81|-1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-1.49|-8.81|0.0059
71748804|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.86||0.0007|TWO_SIDED|95.0|-10.06|-2.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.74|-10.06|0.0007
71748805|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-11.18|-3.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.79|-11.18|<0.0001
71780923|NCT03298867|143061442|SUPERIORITY||Difference in LS mean|9.36|STANDARD_ERROR_OF_MEAN|2.651|<|0.001|TWO_SIDED|95.0|4.08|14.64||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model for repeated measures (MMRM)|||||14.64|4.08|<0.001
71780924|NCT04560998|143061445|SUPERIORITY||The Hodges-Lehmann estimate|1.13||||0.0004|TWO_SIDED|95.0|1.056|1.211|||Wilcoxon (Mann-Whitney)|||||1.211|1.056|0.0004
71748806|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|1.9||0.0001|TWO_SIDED|95.0|-11.18|-3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.72|-11.18|0.0001
71748807|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.89||0.0022|TWO_SIDED|95.0|-9.56|-2.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.11|-9.56|0.0022
71780925|NCT04560998|143061446|SUPERIORITY||The Hodges-Lehmann estimate|1.08||||0.038|TWO_SIDED|95.0|1.004|1.156|||Wilcoxon (Mann-Whitney)|||||1.156|1.004|0.0380
71780926|NCT04560998|143061447|SUPERIORITY||The Hodges-Lehmann estimate|1.0||||0.0108|TWO_SIDED|95.0|0.478|1.518|||Wilcoxon (Mann-Whitney)|||||1.518|0.478|0.0108
71780927|NCT04560998|143061448|SUPERIORITY||The Hodges-Lehmann Estimate|1.11||||0.0046|TWO_SIDED|95.0|1.033|1.197|||Wilcoxon (Mann-Whitney)|||||1.197|1.033|0.0046
71780928|NCT01633853|143061478|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline both in group Vitamin D2.||||0.117
71780929|NCT01633853|143061478|SUPERIORITY_OR_OTHER|||||||0.309|TWO_SIDED||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline in group 1,25(OH)2 Vitamin D3.||||0.309
71748808|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.87||0.0003|TWO_SIDED|95.0|-10.56|-3.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-3.19|-10.56|0.0003
71748809|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.44|-2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 11||-2.13|-9.44|0.0020
71748810|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|1.82||0.0023|TWO_SIDED|95.0|-9.18|-2.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.01|-9.18|0.0023
71748811|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.5|STANDARD_ERROR_OF_MEAN|1.82||0.0004|TWO_SIDED|95.0|-10.06|-2.89||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.89|-10.06|0.0004
71748812|NCT03192176|143005298|SUPERIORITY||LSMean difference|-7.4|STANDARD_ERROR_OF_MEAN|1.84|<|0.0001|TWO_SIDED|95.0|-11.05|-3.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.81|-11.05|<0.0001
71748813|NCT03192176|143005298|SUPERIORITY||LSMean difference|-8.1|STANDARD_ERROR_OF_MEAN|1.86|<|0.0001|TWO_SIDED|95.0|-11.8|-4.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-4.49|-11.80|<0.0001
71748814|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.85||0.0011|TWO_SIDED|95.0|-9.77|-2.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.47|-9.77|0.0011
71780930|NCT01633853|143061478|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED|||||t=-0.593|t-test, 2 sided|||The levels of blood calcium at the 24th month of following up were compared between two groups.||||0.554
71780931|NCT01633853|143061479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group Vitamin D2.||||<0.001
71780932|NCT01633853|143061479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group 1,25(OH)2 Vitamin D3.||||<0.001
71780933|NCT01633853|143061479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P\<0.001, t=-14.982.|t-test, 2 sided|||The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups.||||<0.001
71780934|NCT01633853|143061480|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||Chi-square value=0.099|Chi-squared|||||||0.753
71780935|NCT01633853|143061481|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group Vitamin D2.||||<0.001
71748815|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.9|STANDARD_ERROR_OF_MEAN|1.83||0.0002|TWO_SIDED|95.0|-10.54|-3.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-3.32|-10.54|0.0002
71667538|NCT04995029|142851231|OTHER||CMH Difference|1.26||||0.6111|TWO_SIDED|95.0|-3.61|6.13|||Cochran-Mantel-Haenszel|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|CMH weighted treatment difference and p-value based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as the participant's number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite Intercurrent Events Strategy. The opioid use derivation at a specific visit was the same as that used for the primary efficacy endpoint.||6.13|-3.61|0.6111
71667539|NCT04995029|142851232|OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-6.0|7.99||||||Opioid abstinence between Weeks 10 to 38 (inclusive) was derived as his/her number of visits with negative assessments (defined as negative UDS and TLFB for opioid use) divided by 15. Under this derivation, any missed or skipped visits were counted as positive, in accordance with the composite intercurrent event strategy.||7.99|-6.00|
71748816|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.82||0.0008|TWO_SIDED|95.0|-9.71|-2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-2.56|-9.71|0.0008
71748817|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|2.15||0.0054|TWO_SIDED|95.0|-10.26|-1.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-1.80|-10.26|0.0054
71748818|NCT03192176|143005298|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.15||0.1145|TWO_SIDED|95.0|-7.63|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMMRM|||Week 13||0.83|-7.63|0.1145
71780936|NCT01633853|143061481|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group 1,25(OH)2 Vitamin D3, respectively.||||<0.001
71780937|NCT01633853|143061481|SUPERIORITY_OR_OTHER|||||||0.694|TWO_SIDED|||||t=0.394|t-test, 2 sided|||The levels of blood phosphorus at the 24th month of following up were compared between two groups.||||0.694
71780938|NCT01633853|143061482|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline in group Vitamin D2.||||0.179
71780939|NCT01633853|143061482|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline group 1,25(OH)2 Vitamin D3, respectively.||||0.106
71780940|NCT01633853|143061482|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED|||||t=-0.736|t-test, 2 sided|||The levels of blood iPTH at the 24th month of following up were compared between two groups.||||0.463
71748819|NCT03192176|143005298|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.21||0.2106|TWO_SIDED|95.0|-7.13|1.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.58|-7.13|0.2106
71748820|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.21||0.0685|TWO_SIDED|95.0|-8.39|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|LSMean difference|||Week 13||0.31|-8.39|0.0685
71748821|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.22||0.0029|TWO_SIDED|95.0|-11.02|-2.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-2.29|-11.02|0.0029
71780941|NCT02785432|143061483|SUPERIORITY|||||||0.55||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.55
71780942|NCT02785432|143061484|SUPERIORITY|||||||0.66||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.66
71780943|NCT02785432|143061485|SUPERIORITY|||||||0.51||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.51
71780944|NCT02785432|143061486|SUPERIORITY|||||||0.96||||||Between group comparison at 8 weeks|Wilcoxon (Mann-Whitney)|||||||0.96
71780945|NCT01673867|143061521|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0015|TWO_SIDED|95.92|0.59|0.89|||Log Rank||HR = Nivolumab over docetaxel|||0.89|0.59|0.0015
71780946|NCT00926328|143061544|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71780947|NCT00926328|143061545|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71780948|NCT01227434|143061555|SUPERIORITY_OR_OTHER||Exact binomial distribution|0.1||||0.1|TWO_SIDED||||||Exact binomial distribution|||Compared to historical estimates of PFS-6 months. With 30 patients, there would be 90% power to detect an improvement in the PFS-6 months rate from 10% (historical estimate) to 30% based on a one-sided exact test with alpha=0.1.||||0.10
71780949|NCT04645953|143061561|SUPERIORITY|||||||0.7024|||||||ANOVA|||Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. All statistical tests were 2-sided with a significance value of ≤ 0.05.||||0.7024
71667540|NCT04995029|142851233|OTHER||CMH Difference|2.73|||||TWO_SIDED|95.0|-4.98|10.43||This endpoint was summarized similar to the analysis for #4 above. The opioid abstinence percentage for an individual participant was derived as his/her number of visits with negative assessments divided by 5.|||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||10.43|-4.98|
71667541|NCT04995029|142851234|OTHER||CMH Difference|0.15|||||TWO_SIDED|95.0|-7.49|7.78|||||CMH weighted treatment difference based on the CMH randomization stratified analysis using the Sato (1989) variance equation.|||7.78|-7.49|
71667542|NCT04995029|142851235|OTHER||Mean Difference (Net)|1.49|||||TWO_SIDED|95.0|-4.8|7.78||||||||7.78|-4.80|
71748822|NCT03192176|143005298|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.22||0.0239|TWO_SIDED|95.0|-9.42|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||-0.67|-9.42|0.0239
71748823|NCT03192176|143005298|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|2.15||0.2224|TWO_SIDED|95.0|-6.86|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 13||1.60|-6.86|0.2224
71748824|NCT03192176|143005298|SUPERIORITY||LSMean differencce|-4.8|STANDARD_ERROR_OF_MEAN|2.22||0.0308|TWO_SIDED|95.0|-9.17|-0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.45|-9.17|0.0308
71748825|NCT03192176|143005298|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|2.21||0.4194|TWO_SIDED|95.0|-6.13|2.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.56|-6.13|0.4194
71780950|NCT04645953|143061561|SUPERIORITY|Null hypothesis is there was no difference between groups treated with AZ-010 (1 mg or 3 mg) and the placebo group in the mean number of vomiting/retching events in the 2 hours following. treatment. Baseline, body weight, height, body mass index, age as covariates, and the treatment group and study site as factors. Patients summarized by actual treatment received. Formal statistical tests (ANOVA, when performed) were 2-sided t-tests with a significance value of 0.05.||||||0.2051|||||||ANOVA|||||||0.2051
71835249|NCT00567398|143175252|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
71835250|NCT00567398|143175253|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
71667543|NCT04995029|142851236|OTHER||Mean Difference (Net)|-0.64|||||TWO_SIDED|95.0|-5.38|4.09||||||||4.09|-5.38|
71667544|NCT04995029|142851237|OTHER||Mean Difference (Net)|-1.37|||||TWO_SIDED|95.0|-9.0|6.25||||||||6.25|-9.00|
71667545|NCT04995029|142851243|OTHER||CMH Difference|1.54|||||TWO_SIDED|95.0|-7.56|10.65|||||CMH weighted treatment difference based on the CMH randomisation stratified analysis using the Sato (1989) variance equation.|||10.65|-7.56|
71667546|NCT04995029|142851244|OTHER||Cox Proportional Hazard|0.82|||||TWO_SIDED|95.0|0.65|1.03|||||Estimated using a Cox proportional hazard model, with treatment arm as a single covariate, stratified by the randomisation strata. Note that the estimation is impacted by last observed visit for the OLTP (including out-of-window visits).|||1.03|0.65|
71748826|NCT03192176|143005298|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|2.29||0.3759|TWO_SIDED|95.0|-6.55|2.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.48|-6.55|0.3759
71748827|NCT03192176|143005298|SUPERIORITY||LSMean differencce|-2.8|STANDARD_ERROR_OF_MEAN|2.29||0.2285|TWO_SIDED|95.0|-7.26|1.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||1.74|-7.26|0.2285
71748828|NCT03192176|143005298|SUPERIORITY||LSMean difference|-6.2|STANDARD_ERROR_OF_MEAN|2.29||0.0072|TWO_SIDED|95.0|-10.71|-1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-1.70|-10.71|0.0072
71780951|NCT04645953|143061562|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
71780952|NCT04645953|143061562|SUPERIORITY|Participants were asked to rate their anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
71780953|NCT04645953|143061563|SUPERIORITY|||||||0.8299||||||Prior Episode Duration 1mg AZ-010|Mixed Models Analysis|||||||0.8299
71835251|NCT00567398|143175253|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
71835252|NCT00567398|143175254|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
71835253|NCT00567398|143175254|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
71835254|NCT00567398|143175255|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
71667547|NCT03690388|142851247|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|96.0|0.13|0.36|||Log Rank|||||0.36|0.13|< 0.0001
71667548|NCT03915652|142851252|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.34|TWO_SIDED|95.0|-2.88|1.02|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and appointment nonadherence during the intervention was compared with the 12 months prior.||1.02|-2.88|0.34
71667549|NCT03915652|142851253|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.34|TWO_SIDED|95.0|-1.08|0.39|||t-test, 2 sided|Paired t-test||Waves 1 and 2 were combined and emergency department visits and hospitalizations during the intervention was compared with the 12 months prior.||0.39|-1.08|0.34
71667550|NCT03915652|142851254|SUPERIORITY||Mean Difference (Final Values)|0.59|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||t-test, 1 sided|One sided t-test of percent of needs remaining from 100%.||Wave 1 and Wave 2 were combined and the quality metric at the end of the 12-month intervention was compared to the metric from the start of the intervention.||0.73|0.45|<0.001
71667551|NCT03915652|142851255|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.51|TWO_SIDED|95.0|-19.8|34.8|||t-test, 2 sided|||||34.8|-19.8|0.51
71667552|NCT03915652|142851256|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.17|TWO_SIDED|95.0|-0.43|1.92|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared post to pre.||1.92|-0.43|0.17
71667553|NCT03915652|142851257|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.72|TWO_SIDED|95.0|-4.92|6.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, compared pre/post intervention||6.52|-4.92|0.72
71667554|NCT03915652|142851258|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.5|TWO_SIDED|95.0|-6.22|10.22|||t-test, 2 sided|||Waves 1 and 2 are combined; pre/post survey analysis||10.22|-6.22|0.50
71667555|NCT03915652|142851259|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.01|TWO_SIDED|95.0|1.06|6.47|||t-test, 2 sided|||Waves 1 and 2 combined; pre/post analysis||6.47|1.06|0.01
71667556|NCT03915652|142851260|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.77|TWO_SIDED|95.0|-1.27|0.98|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined, pre/post test||0.98|-1.27|0.77
71667557|NCT03915652|142851261|SUPERIORITY||Mean Difference (Final Values)|2.14||||0.37|TWO_SIDED|95.0|-3.23|7.52|||t-test, 2 sided|Paired t-test||Waves 1 and 2 combined; pre/post analysis||7.52|-3.23|0.37
71667558|NCT04909853|142851271|OTHER||Ratio of Adjusted Geometric Means|129.78|||||TWO_SIDED|90.0|101.93|165.25|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||165.25|101.93|
71667559|NCT04909853|142851271|OTHER||Ratio of Adjusted Geometric Means|138.12|||||TWO_SIDED|90.0|113.18|168.55|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||168.55|113.18|
71667560|NCT04909853|142851271|OTHER||Ratio of Adjusted Geometric Means|148.02|||||TWO_SIDED|90.0|111.4|196.68|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||196.68|111.40|
71667561|NCT04909853|142851272|OTHER||Ratio of Adjusted Geometric Means|123.84|||||TWO_SIDED|90.0|99.64|153.91|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||153.91|99.64|
71667562|NCT04909853|142851272|OTHER||Ratio of Adjusted Geometric Means|187.4|||||TWO_SIDED|90.0|148.52|236.46|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||236.46|148.52|
71667563|NCT04909853|142851272|OTHER||Ratio of Adjusted Geometric Means|304.49|||||TWO_SIDED|90.0|237.6|390.21|||||Analysis used one-way ANOVA model with renal function as a fixed effect. The ratio of adjusted geometric means (test \[impaired\]/reference \[normal\]) and 90% confidence interval (CI) were expressed as percentages.|||390.21|237.60|
71667564|NCT00535405|142851385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.5|-12.0||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-12.0|-17.5|<0.001
71780954|NCT04645953|143061563|SUPERIORITY|||||||0.2346||||||Prior Episode Duration 3 mg AZ-010|Mixed Models Analysis|||||||0.2346
71780955|NCT04645953|143061563|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 1mg AZ-010|Mixed Models Analysis|||||||0.3997
71780956|NCT04645953|143061563|SUPERIORITY|||||||0.3997||||||Prior Episode intensity 3mg AZ-010|Mixed Models Analysis|||||||0.3997
71780957|NCT04645953|143061564|SUPERIORITY|||||||0.3847|||||||Mantel Haenszel|||||||0.3847
71780958|NCT04645953|143061564|SUPERIORITY|||||||0.1785|||||||Mantel Haenszel|||||||0.1785
71780959|NCT04645953|143061565|SUPERIORITY|||||||0.9732|||||||Mantel Haenszel|||||||0.9732
71780960|NCT04645953|143061565|SUPERIORITY|||||||0.1471|||||||Mantel Haenszel|||||||0.1471
71780961|NCT04645953|143061566|SUPERIORITY|||||||0.1337|||||||ANOVA|||The RINVR is an 8-part questionnaire with each item scored from 0-4, for a total scoring range of 0-32. A lower score indicates less distress related to nausea, vomiting, and retching. The data shown is collected within the first 24 hours after the first at-home dose.||||0.1337
71780962|NCT04645953|143061566|SUPERIORITY|||||||0.7224|||||||ANOVA|||||||0.7224
71780963|NCT04645953|143061567|SUPERIORITY|||||||0.0504|||||||Mixed Models Analysis|||Participants were asked to rate their abdominal pain, nausea, and anxiety/panic on scale of 0-100 at each time point. The higher the number, the more intense the symptom.||||0.0504
71780964|NCT04645953|143061567|SUPERIORITY|||||||0.8246|||||||Mixed Models Analysis|||||||0.8246
71667565|NCT00535405|142851385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-10.3|-4.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-4.8|-10.3|<0.001
71667566|NCT00535405|142851385|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.0|-5.5||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.||||-5.5|-11.0|<0.001
71667567|NCT00535405|142851386|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|12.62|STANDARD_ERROR_OF_MEAN|3.23|<|0.001||95.0|7.64|20.83||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|"Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.~Generalized Estimating Equations (GEE)"|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||20.83|7.64|<0.001
71667568|NCT00535405|142851386|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.83|STANDARD_ERROR_OF_MEAN|0.83|<|0.001||95.0|2.51|5.85||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.85|2.51|<0.001
71667569|NCT00535405|142851386|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.66|STANDARD_ERROR_OF_MEAN|0.79|<|0.001||95.0|2.39|5.6|||Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||5.60|2.39|<0.001
71667570|NCT00535405|142851387|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|3.05|STANDARD_ERROR_OF_MEAN|0.62|<|0.001||95.0|2.04|4.55||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.55|2.04|<0.001
71667571|NCT00535405|142851387|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.54|STANDARD_ERROR_OF_MEAN|0.32||0.039||95.0|1.02|2.32||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.32|1.02|0.039
71667572|NCT00535405|142851387|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.81|STANDARD_ERROR_OF_MEAN|0.43||0.023||95.0|1.14|2.87||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.87|1.14|0.023
71667573|NCT00535405|142851388|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|4.47|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|2.76|7.24||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||7.24|2.76|<0.001
71667574|NCT00535405|142851388|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.77|STANDARD_ERROR_OF_MEAN|0.46||0.026||95.0|1.07|2.94||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.94|1.07|0.026
71667575|NCT00535405|142851388|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.27|STANDARD_ERROR_OF_MEAN|0.71||0.017||95.0|1.23|4.18||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.18|1.23|0.017
71667576|NCT00535405|142851389|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|7.6|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|4.31|13.42||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.42|4.31|<0.001
71667577|NCT00535405|142851389|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.95|STANDARD_ERROR_OF_MEAN|0.69|<|0.001||95.0|1.86|4.67||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||4.67|1.86|<0.001
71667578|NCT00535405|142851389|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|2.15|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|1.42|3.27||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||3.27|1.42|<0.001
71667579|NCT00535405|142851390|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|6.02|STANDARD_ERROR_OF_MEAN|2.45|<|0.001||95.0|2.71|13.38||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||13.38|2.71|<0.001
71780965|NCT04645953|143061568|SUPERIORITY|||||||0.9664|||||||Mixed Models Analysis|||||||0.9664
71780966|NCT04645953|143061568|SUPERIORITY|||||||0.7919|||||||Mixed Models Analysis|||||||0.7919
71667580|NCT00535405|142851390|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.67|STANDARD_ERROR_OF_MEAN|0.47||0.069||95.0|0.96|2.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.60|0.96|0.069
71667581|NCT00535405|142851390|SUPERIORITY_OR_OTHER_LEGACY||Ratio of odds|1.78|STANDARD_ERROR_OF_MEAN|0.44||0.039|TWO_SIDED|95.0|1.1|2.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva|||2.90|1.10|0.039
71748829|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.31||0.0338|TWO_SIDED|95.0|-9.46|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||-0.38|-9.46|0.0338
71748830|NCT03192176|143005298|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|2.21||0.3026|TWO_SIDED|95.0|-6.64|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 14||2.07|-6.64|0.3026
71748831|NCT03192176|143005298|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.16||0.312|TWO_SIDED|95.0|-6.45|2.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||2.07|-6.45|0.3120
71748832|NCT03192176|143005298|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.15||0.6816|TWO_SIDED|95.0|-5.11|3.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||3.34|-5.11|0.6816
71748833|NCT03192176|143005298|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|2.26||0.8599|TWO_SIDED|95.0|-4.85|4.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.05|-4.85|0.8599
71748834|NCT03192176|143005298|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.23||0.9093|TWO_SIDED|95.0|-4.64|4.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.13|-4.64|0.9093
71780967|NCT04613375|143061569|OTHER||Adjusted VE|16.91||||0.3685|TWO_SIDED|95.0|-24.43|44.52|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with respiratory syncytial virus (RSV) infection.|||44.52|-24.43|0.3685
71780968|NCT04613375|143061570|OTHER||Adjusted VE|49.27||||0.0817|TWO_SIDED|95.0|-8.9|76.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||76.37|-8.9|0.0817
71667582|NCT03091179|142851405|EQUIVALENCE|P value was calculated using the means and standard deviations for each of the patient characteristics.||||||0.006|||||||t-test, 2 sided|||||||0.006
71748835|NCT03192176|143005298|SUPERIORITY||LSMean difference|-4.0|STANDARD_ERROR_OF_MEAN|2.26||0.0788|TWO_SIDED|95.0|-8.43|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.46|-8.43|0.0788
71748836|NCT03192176|143005298|SUPERIORITY||LSMean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.26||0.1278|TWO_SIDED|95.0|-7.92|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.00|-7.92|0.1278
71748837|NCT03192176|143005298|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|2.15||0.9848|TWO_SIDED|95.0|-4.19|4.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit and smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||4.27|-4.19|0.9848
71748838|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|7.05||0.0388|TWO_SIDED|95.0|0.76|28.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||28.49|0.76|0.0388
71748839|NCT03192176|143005299|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.08||0.0012|TWO_SIDED|95.0|9.17|37.02||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||37.02|9.17|0.0012
71780969|NCT04613375|143061570|OTHER||Adjusted VE|4.72||||0.8367|TWO_SIDED|95.0|-50.96|39.87|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||39.87|-50.96|0.8367
71780970|NCT04613375|143061570|OTHER||Adjusted VE|12.02||||0.7469|TWO_SIDED|95.0|-91.53|59.59|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||59.59|-91.53|0.7469
71780971|NCT04613375|143061576|OTHER||Adjusted VE|25.96||||0.1827|TWO_SIDED|95.0|-15.21|52.42|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|||52.42|-15.21|0.1827
71780972|NCT04613375|143061577|OTHER||Adjusted VE|68.86||||0.028|TWO_SIDED|95.0|11.86|89.0|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\<2 years||89|11.86|0.028
71748840|NCT03192176|143005299|SUPERIORITY||LSMean difference|37.3|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|23.41|51.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||51.22|23.41|<0.0001
71748841|NCT03192176|143005299|SUPERIORITY||LSMean difference|41.0|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|26.88|55.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||55.05|26.88|<0.0001
71748842|NCT03192176|143005299|SUPERIORITY||LSMean difference|8.2|STANDARD_ERROR_OF_MEAN|7.19||0.2569|TWO_SIDED|95.0|-5.98|22.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||22.32|-5.98|0.2569
71748843|NCT03192176|143005299|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.07||0.0003|TWO_SIDED|95.0|11.65|39.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||39.47|11.65|0.0003
71748844|NCT03192176|143005299|SUPERIORITY||LSMean difference|30.2|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|16.39|44.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||44.06|16.39|<0.0001
71748845|NCT03192176|143005299|SUPERIORITY||LSMean difference|15.9|STANDARD_ERROR_OF_MEAN|7.02||0.024|TWO_SIDED|95.0|2.11|29.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||29.71|2.11|0.0240
71780973|NCT04613375|143061577|OTHER||Adjusted VE|7.97||||0.738|TWO_SIDED|95.0|-49.73|43.43|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|2 years to \<5 years||43.43|-49.73|0.738
71748846|NCT03192176|143005299|SUPERIORITY||LSMean difference|24.5|STANDARD_ERROR_OF_MEAN|7.05||0.0006|TWO_SIDED|95.0|10.62|38.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.37|10.62|0.0006
71748847|NCT03192176|143005299|SUPERIORITY||LSMean differencce|33.7|STANDARD_ERROR_OF_MEAN|7.03|<|0.0001|TWO_SIDED|95.0|19.87|47.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.52|19.87|<0.0001
71748848|NCT03192176|143005299|SUPERIORITY||LSMean difference|38.0|STANDARD_ERROR_OF_MEAN|7.15|<|0.0001|TWO_SIDED|95.0|23.93|52.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||52.04|23.93|<0.0001
71748849|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|7.16||0.0441|TWO_SIDED|95.0|0.38|28.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||28.53|0.38|0.0441
71780974|NCT04613375|143061577|OTHER||Adjusted VE|30.06||||0.4327|TWO_SIDED|95.0|-70.86|71.37|||Wald Test||Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection.|\>=5 years||71.37|-70.86|0.4327
71845297|NCT00857766|143204581|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.42||||0.065||95.0|-0.88|0.03|||ANCOVA||LS mean difference is calculated as FSC 250/50 minus Placebo and is adjusted for treatment, investigator, sex, smoking status, age, body mass index (BMI), waist circumference, treatment by sex interaction, age by BMI interaction, and baseline value.|||0.03|-0.88|0.065
71845298|NCT00857766|143204582|SUPERIORITY_OR_OTHER||Least squares analysis|-0.6|STANDARD_ERROR_OF_MEAN|0.86||0.469||95.0|-2.3|1.1|||ANCOVA|||||1.1|-2.3|0.469
71845299|NCT00857766|143204583|SUPERIORITY_OR_OTHER||Least squares analysis|127.0|STANDARD_ERROR_OF_MEAN|35.5|<|0.001||95.0|57.0|197.0|||ANCOVA|||||197|57|<0.001
71845300|NCT01787032|143204590|SUPERIORITY_OR_OTHER||Ratio|373.66|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|346.029|403.507|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||403.507|346.029|
71845301|NCT01787032|143204590|SUPERIORITY_OR_OTHER||Ratio|266.94|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|243.267|292.914|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.914|243.267|
71845302|NCT01787032|143204591|SUPERIORITY_OR_OTHER||Ratio|261.34|STANDARD_DEVIATION|37.3|||TWO_SIDED|90.0|211.692|322.633|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||322.633|211.692|
71667583|NCT03282916|142851431|SUPERIORITY|Linear mixed-effects models (LMM) were used to assess the treatment effects on the outcome with change score from baseline as the dependent variable and treatment, study time point, and their interaction as predictors, adjusting for baseline value of the outcome.|Mean Difference (Final Values)|3.91|||<|0.05|TWO_SIDED|95.0|1.03|6.8||Not adjusted for multiple comparisons|Mixed Models Analysis|Adjusting for baseline value of ADAS-Cog11||"Null hypothesis: there is no difference in change in ADAS-Cog11 between valacyclovir and placebo treatment.~A sample size of 130 participants (65 per arm) was originally projected to detect Cohen's d of 0.50 with 80% power at 5% significance level. Recruitment target was reduced to 120 participants due to pandemic-related recruitment delays and required study completion within the extended funding timeline. For n=120, the minimum detectable effect size increased slightly to Cohen's d of 0.52."||6.80|1.03|<0.05
71667584|NCT03164616|142851435|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00093|TWO_SIDED|95.0|0.62|0.885||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and confidence interval (CI) were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. A hazard ratio (HR) \<1 favors D + SoC to be associated with a longer PFS than SoC alone.||0.885|0.620|0.00093
71780975|NCT00002651|143061578|NON_INFERIORITY_OR_EQUIVALENCE|The overall type I error rate used is 0.05. The type II error rate is 0.10 (power = 0.9). The trial planned for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. A hazard ratio of 1.0 was used as the specific alternative in the trial size computations. Thus, rejection of the hypothesis will be evidence against the possibility that the intermittent CAD hazard ratio is larger than the continuous CAD hazard ratio by 20% or more.|Hazard Ratio (HR)|1.1||||0.15|TWO_SIDED|90.0|0.99|1.23|||Regression, Cox|||||1.23|0.99|0.15
71748850|NCT03192176|143005299|SUPERIORITY||LSMean difference|19.4|STANDARD_ERROR_OF_MEAN|7.04||0.0061|TWO_SIDED|95.0|5.58|33.28||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.28|5.58|0.0061
71748851|NCT03192176|143005299|SUPERIORITY||LSMean difference|25.7|STANDARD_ERROR_OF_MEAN|7.01||0.0003|TWO_SIDED|95.0|11.96|39.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||39.53|11.96|0.0003
71748852|NCT03192176|143005299|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.55||0.0078|TWO_SIDED|95.0|5.36|35.07||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||35.07|5.36|0.0078
71748853|NCT03192176|143005299|SUPERIORITY||LSMean difference|28.3|STANDARD_ERROR_OF_MEAN|7.59||0.0002|TWO_SIDED|95.0|13.36|43.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.22|13.36|0.0002
71748854|NCT03192176|143005299|SUPERIORITY||LSMean difference|36.9|STANDARD_ERROR_OF_MEAN|7.55|<|0.0001|TWO_SIDED|95.0|22.07|51.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||51.77|22.07|<0.0001
71748855|NCT03192176|143005299|SUPERIORITY||LSMean difference|40.5|STANDARD_ERROR_OF_MEAN|7.69|<|0.0001|TWO_SIDED|95.0|25.41|55.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRm|||Week 3||55.67|25.41|<0.0001
71748856|NCT03192176|143005299|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.7||0.0108|TWO_SIDED|95.0|4.59|34.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||34.88|4.59|0.0108
71780976|NCT00002651|143061579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.09|TWO_SIDED|95.0|-0.31|3.97||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.97|-0.31|0.09
71667585|NCT03164616|142851436|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07581|TWO_SIDED|95.0|0.724|1.016||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer OS than SoC alone.||1.016|0.724|0.07581
71677054|NCT00746564|142872548|SUPERIORITY_OR_OTHER||percentage of interpretable recording|99.2|||||TWO_SIDED|95.0|98.5|100.0||||||"The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:~Duration (sec) of interpretable recording / Total duration of recording time (sec)"||100|98.5|
71748857|NCT03192176|143005299|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|7.56||0.0011|TWO_SIDED|95.0|10.09|39.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||39.84|10.09|0.0011
71748858|NCT03192176|143005299|SUPERIORITY||LSMean difference|30.9|STANDARD_ERROR_OF_MEAN|7.53|<|0.0001|TWO_SIDED|95.0|16.03|45.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.67|16.03|<0.0001
71748859|NCT03192176|143005299|SUPERIORITY||LSMean difference|20.5|STANDARD_ERROR_OF_MEAN|7.47||0.0063|TWO_SIDED|95.0|5.84|35.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||35.23|5.84|0.0063
71748860|NCT03192176|143005299|SUPERIORITY||LSMean difference|28.7|STANDARD_ERROR_OF_MEAN|7.49||0.0002|TWO_SIDED|95.0|13.98|43.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.46|13.98|0.0002
71748861|NCT03192176|143005299|SUPERIORITY||LSMean difference|33.3|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|18.66|48.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||48.00|18.66|<0.0001
71748862|NCT03192176|143005299|SUPERIORITY||LSMean difference|41.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|26.52|56.41||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.41|26.52|<0.0001
71835255|NCT02201108|143175256|SUPERIORITY||Hazard Ratio (HR)|0.657||||0.2949|TWO_SIDED|95.0|0.388|1.113||Threshold for significance was \< 0.05.|Stratified Log-Rank test|P-value derived from log-rank test with stratification of region and pubertal status.|Hazard ratio was estimated using a Cox proportional-hazards model with factors for treatment group, region, pubertal status, age, and number of relapses in the year prior to randomization as covariates and with robust variance estimation.|||1.113|0.388|0.2949
71748863|NCT03192176|143005299|SUPERIORITY||LSMean difference|19.7|STANDARD_ERROR_OF_MEAN|7.59||0.0098|TWO_SIDED|95.0|4.78|34.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||34.66|4.78|0.0098
71748864|NCT03192176|143005299|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|15.26|44.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||44.61|15.26|<0.0001
71748865|NCT03192176|143005299|SUPERIORITY||LSMean difference|33.1|STANDARD_ERROR_OF_MEAN|7.43|<|0.0001|TWO_SIDED|95.0|18.5|47.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||47.73|18.50|<0.0001
71748866|NCT03192176|143005299|SUPERIORITY||LSMean difference|15.4|STANDARD_ERROR_OF_MEAN|7.1||0.0303|TWO_SIDED|95.0|1.48|29.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||29.40|1.48|0.0303
71748867|NCT03192176|143005299|SUPERIORITY||LSMean difference|24.8|STANDARD_ERROR_OF_MEAN|7.11||0.0006|TWO_SIDED|95.0|10.77|38.74||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.74|10.77|0.0006
71748868|NCT03192176|143005299|SUPERIORITY||LSMean difference|30.8|STANDARD_ERROR_OF_MEAN|7.11|<|0.0001|TWO_SIDED|95.0|16.77|44.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.75|16.77|<0.0001
71667586|NCT03164616|142851437|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00031|TWO_SIDED|95.0|0.6|0.86||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS than SoC alone.||0.860|0.600|0.00031
71667587|NCT03164616|142851438|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00304|TWO_SIDED|95.0|0.65|0.916||Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer OS than SoC alone.||0.916|0.650|0.00304
71667588|NCT03164616|142851439|SUPERIORITY||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.382|2.619||||||D + SoC vs SoC alone. An odds ratio \>1 favors D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.619|1.382|
71748869|NCT03192176|143005299|SUPERIORITY||LSMean difference|38.8|STANDARD_ERROR_OF_MEAN|7.23|<|0.0001|TWO_SIDED|95.0|24.55|53.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||53.00|24.55|<0.0001
71748870|NCT03192176|143005299|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.2||0.0086|TWO_SIDED|95.0|4.88|33.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||33.23|4.88|0.0086
71748871|NCT03192176|143005299|SUPERIORITY||LSMean difference|22.3|STANDARD_ERROR_OF_MEAN|7.09||0.0018|TWO_SIDED|95.0|8.33|36.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||36.24|8.33|0.0018
71748872|NCT03192176|143005299|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|7.07||0.0004|TWO_SIDED|95.0|11.24|39.05||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||39.05|11.24|0.0004
71748873|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.62||0.0282|TWO_SIDED|95.0|1.56|27.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.60|1.56|0.0282
71748874|NCT03192176|143005299|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|6.63||0.0029|TWO_SIDED|95.0|6.85|32.92||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.92|6.85|0.0029
71835256|NCT02201108|143175258|OTHER||Relative risk ratio|0.511|||||TWO_SIDED|95.0|0.343|0.762||||||||0.762|0.343|
71835257|NCT02201108|143175259|OTHER||Relative risk ratio|0.57|||||TWO_SIDED|95.0|0.331|0.983||||||||0.983|0.331|
71748875|NCT03192176|143005299|SUPERIORITY||LSMean difference|29.7|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|16.58|42.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||42.73|16.58|<0.0001
71748876|NCT03192176|143005299|SUPERIORITY||LSMean difference|35.7|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.42|48.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.99|22.42|<0.0001
71748877|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.74||0.0304|TWO_SIDED|95.0|1.4|27.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||27.90|1.40|0.0304
71748878|NCT03192176|143005299|SUPERIORITY||LSMean difference|20.4|STANDARD_ERROR_OF_MEAN|6.64||0.0022|TWO_SIDED|95.0|7.38|33.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.50|7.38|0.0022
71748879|NCT03192176|143005299|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.59|<|0.0001|TWO_SIDED|95.0|13.56|39.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||39.50|13.56|<0.0001
71748880|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.4|STANDARD_ERROR_OF_MEAN|6.87||0.0362|TWO_SIDED|95.0|0.93|27.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||27.95|0.93|0.0362
71780977|NCT00002651|143061580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.88||||0.003|TWO_SIDED|95.0|1.0|4.76||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||4.76|1.00|0.003
71780978|NCT00002651|143061581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|||<|0.001|TWO_SIDED|95.0|-14.0|-5.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||-5|-14|<0.001
71780979|NCT00002651|143061582|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.04|TWO_SIDED|95.0|1.0|36.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||36|1|0.04
71748881|NCT03192176|143005299|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.88||0.0009|TWO_SIDED|95.0|9.41|36.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.47|9.41|0.0009
71748882|NCT03192176|143005299|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|6.91|<|0.0001|TWO_SIDED|95.0|15.27|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||42.46|15.27|<0.0001
71748883|NCT03192176|143005299|SUPERIORITY||LSMean difference|36.8|STANDARD_ERROR_OF_MEAN|7.01|<|0.0001|TWO_SIDED|95.0|22.99|50.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||50.57|22.99|<0.0001
71748884|NCT03192176|143005299|SUPERIORITY||LSMean difference|15.6|STANDARD_ERROR_OF_MEAN|6.99||0.0265|TWO_SIDED|95.0|1.83|29.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||29.34|1.83|0.0265
71748885|NCT03192176|143005299|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.89||0.0023|TWO_SIDED|95.0|7.6|34.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.71|7.60|0.0023
71780980|NCT00002651|143061583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.32||||0.23|TWO_SIDED|95.0|-0.83|3.46||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided|||||3.46|-0.83|0.23
71780981|NCT00304746|143061593|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.|mixed effects linear regression analysis|||Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.||||0.71
71780982|NCT02527161|143061620|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71780983|NCT02527161|143061621|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Pain||||<0.0001
71780984|NCT02527161|143061621|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Pain||||0.0013
71780985|NCT02527161|143061621|SUPERIORITY|||||||0.3316|||||||ANOVA|||Change from 3 months to 6 months KOOS Pain||||0.3316
71780986|NCT02527161|143061621|SUPERIORITY|||||||0.3366|||||||ANOVA|||Change from 6 months to 1 year KOOS Pain||||0.3366
71780987|NCT02527161|143061621|SUPERIORITY|||||||0.9826|||||||ANOVA|||Change from 1 year to 2 year KOOS Pain||||0.9826
71667589|NCT03164616|142851439|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|1.26|2.367||||||T + D + SoC vs SoC alone. An odds ratio \>1 favors T + D + SoC compared to SoC alone. Analysis was performed using logistic regression adjusting for PD-L1 tumor expression (TC ≥50% vs TC \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB), with the CI calculated using a profile likelihood approach.||2.367|1.260|
71667590|NCT03164616|142851442|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.666|0.928|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|D + SoC vs SoC alone. An HR \<1 favors D + SoC to be associated with a longer PFS2 than SoC alone.||0.928|0.666|
71748886|NCT03192176|143005299|SUPERIORITY||LSMean difference|27.1|STANDARD_ERROR_OF_MEAN|6.85|<|0.0001|TWO_SIDED|95.0|13.64|40.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||40.59|13.64|<0.0001
71748887|NCT03192176|143005299|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|6.8||0.158|TWO_SIDED|95.0|-3.75|22.99||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||22.99|-3.75|0.1580
71667591|NCT03164616|142851442|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.632|0.883|||||The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.|T + D + SoC vs SoC alone. An HR \<1 favors T + D + SoC to be associated with a longer PFS2 than SoC alone.||0.883|0.632|
71748888|NCT03192176|143005299|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.8||0.0082|TWO_SIDED|95.0|4.72|31.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.50|4.72|0.0082
71748889|NCT03192176|143005299|SUPERIORITY||LSMean difference|25.2|STANDARD_ERROR_OF_MEAN|6.85||0.0003|TWO_SIDED|95.0|11.77|38.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||38.71|11.77|0.0003
71667592|NCT00489255|142851465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.09|TWO_SIDED|95.0|0.17|1.11|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test for treatment was stratified by site.||The null hypothesis was no difference between treatments.||1.11|0.17|0.09
71748890|NCT03192176|143005299|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|6.96|<|0.0001|TWO_SIDED|95.0|16.93|44.31||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||44.31|16.93|<0.0001
71667593|NCT00489255|142851466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44||||0.025|TWO_SIDED|95.0|0.21|0.9|||Cochran-Mantel-Haenszel|||||0.90|0.21|0.025
71748891|NCT03192176|143005299|SUPERIORITY||LSMean difference|11.2|STANDARD_ERROR_OF_MEAN|6.93||0.1074|TWO_SIDED|95.0|-2.45|24.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||24.84|-2.45|0.1074
71748892|NCT03192176|143005299|SUPERIORITY||LSMean difference|18.3|STANDARD_ERROR_OF_MEAN|6.83||0.0077|TWO_SIDED|95.0|4.87|31.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||31.76|4.87|0.0077
71748893|NCT03192176|143005299|SUPERIORITY||LSMean difference|23.6|STANDARD_ERROR_OF_MEAN|6.79||0.0006|TWO_SIDED|95.0|10.29|37.01||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||37.01|10.29|0.0006
71667594|NCT00489255|142851467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25||||0.005|TWO_SIDED|95.0|0.09|0.7|||Cochran-Mantel-Haenszel|||||0.70|0.09|0.005
71667595|NCT00489255|142851468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.23|2.48|||Cochran-Mantel-Haenszel|||||2.48|0.23|0.65
71667596|NCT00489255|142851469|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.21||||0.32|TWO_SIDED|95.0|-0.64|0.21|||ANOVA|Treatment effect in ANOVA was adjusted for site.||||0.21|-0.64|0.32
71667597|NCT00489255|142851470|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07||||0.001|TWO_SIDED|95.0|-1.71|-0.43|||ANOVA|||||-0.43|-1.71|0.001
71667598|NCT00489255|142851471|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.01||||0.95|TWO_SIDED|95.0|-0.2|0.19|||ANOVA|||||0.19|-0.20|0.95
71667599|NCT00489255|142851472|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.88
71780988|NCT02527161|143061621|SUPERIORITY|||||||0.9276|||||||ANOVA|||Change from 2 year to 5 year KOOS Pain||||0.9276
71835258|NCT02201108|143175262|OTHER||Relative risk ratio|0.498|||||TWO_SIDED|95.0|0.296|0.836||||||||0.836|0.296|
71667600|NCT00489255|142851473|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site||||||0.019
71667601|NCT00489255|142851474|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|||||||0.29
71667602|NCT00489255|142851475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.17|TWO_SIDED|95.0|0.5|1.1||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.1|0.5|0.17
71667603|NCT00489255|142851476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.008|TWO_SIDED|95.0|0.1|0.7||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||0.7|0.1|0.008
71667604|NCT00489255|142851477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.49|TWO_SIDED|95.0|0.6|1.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||1.3|0.6|0.49
71667605|NCT00489255|142851478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|0.4
71667606|NCT00489255|142851479|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.62||95.0|0.6|2.3||Cox's proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox|||||2.3|0.6|0.62
71667607|NCT00489255|142851480|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.96|TWO_SIDED|95.0|-3.59|3.76|||ANOVA|ANCOVA model with baseline score (score at Visit 1/Screening) as a covariate, and site and treatment as factors.||||3.76|-3.59|0.96
71667608|NCT00489255|142851481|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.93|TWO_SIDED|95.0|-4.37|4.02|||ANOVA|||||4.02|-4.37|0.93
71667609|NCT00489255|142851482|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.84|TWO_SIDED|95.0|-4.12|3.34|||ANOVA|||||3.34|-4.12|0.84
71667610|NCT00489255|142851483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.97||||0.25|TWO_SIDED|95.0|-2.17|8.11|||ANOVA|||||8.11|-2.17|0.25
71667611|NCT00489255|142851484|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.47||||0.46|TWO_SIDED|95.0|-2.47|5.4|||ANOVA|||||5.40|-2.47|0.46
71667612|NCT00489255|142851485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.96||||0.33|TWO_SIDED|95.0|-3.13|9.06|||ANOVA|||||9.06|-3.13|0.33
71667613|NCT00489255|142851486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.93|TWO_SIDED|95.0|-5.57|6.11|||ANOVA|||||6.11|-5.57|0.93
71667614|NCT01328184|142851488|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|102.82|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|97.58|108.35|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||108.35|97.58|
71667615|NCT01328184|142851489|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|101.94|STANDARD_DEVIATION|5.9|||TWO_SIDED|90.0|98.54|105.47|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||105.47|98.54|
71667616|NCT01328184|142851490|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|99.22|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|93.4|105.39|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV).|No formal testing, investigation of relative bioavailability.||105.39|93.40|
71667617|NCT01328184|142851491|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|105.81|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|99.47|112.55|||ANOVA|Based on ANOVA with fixed term for treatment and random term for subject.|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.||112.55|99.47|
71667618|NCT01959295|142851520|SUPERIORITY|||||||0.5086|||||||Mantel Haenszel|||The superiority of ASP2151 200mg to ASP2151 placebo was assessed by Mantel-Haenszel method, adjusted by disease type (labial/facial herpes and recurrent genital herpes) .||||0.5086
71667619|NCT04917861|142851529|OTHER||Geometric Mean Ratio (GMR)|7.002|||||TWO_SIDED|95.0|5.451|8.992|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||8.992|5.451|
71667620|NCT04917861|142851529|OTHER||GMR|7.123|||||TWO_SIDED|95.0|5.467|9.279|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||9.279|5.467|
71667621|NCT04917861|142851529|OTHER||GMR|2.674|||||TWO_SIDED|95.0|1.961|3.646|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.646|1.961|
71667622|NCT04917861|142851529|OTHER||GMR|7.208|||||TWO_SIDED|95.0|5.428|9.571|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||9.571|5.428|
71667623|NCT04917861|142851529|OTHER||GMR|7.979|||||TWO_SIDED|95.0|6.106|10.425|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||10.425|6.106|
71667624|NCT04917861|142851529|OTHER||GMR|1.516|||||TWO_SIDED|95.0|1.229|1.869|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seronegative participants|||1.869|1.229|
71667625|NCT04917861|142851529|OTHER||GMR|6.785|||||TWO_SIDED|95.0|4.562|10.092|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||10.092|4.562|
71667626|NCT04917861|142851529|OTHER||GMR|6.319|||||TWO_SIDED|95.0|4.03|9.909|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||9.909|4.030|
71780989|NCT02527161|143061622|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS Symptoms||||<0.0001
71667627|NCT04917861|142851529|OTHER||GMR|7.028|||||TWO_SIDED|95.0|4.056|12.18|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-seropositive participants|||12.180|4.056|
71667628|NCT04917861|142851530|OTHER||GMR|5.312|||||TWO_SIDED|95.0|4.149|6.802|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.802|4.149|
71667629|NCT04917861|142851530|OTHER||GMR|5.346|||||TWO_SIDED|95.0|4.128|6.922|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||6.922|4.128|
71667630|NCT04917861|142851530|OTHER||GMR|2.325|||||TWO_SIDED|95.0|1.721|3.14|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||3.140|1.721|
71667631|NCT04917861|142851530|OTHER||GMR|4.221|||||TWO_SIDED|95.0|3.322|5.363|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||5.363|3.322|
71667632|NCT04917861|142851530|OTHER||GMR|5.3|||||TWO_SIDED|95.0|4.243|6.62|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||6.620|4.243|
71667633|NCT04917861|142851530|OTHER||GMR|1.206|||||TWO_SIDED|95.0|1.033|1.407|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||1.407|1.033|
71667634|NCT04917861|142851530|OTHER||GMR|6.493|||||TWO_SIDED|95.0|4.358|9.674|||||GMR (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||9.674|4.358|
71667635|NCT04917861|142851530|OTHER||GMR|5.452|||||TWO_SIDED|95.0|3.43|8.665|||||GMR (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||8.665|3.430|
71667636|NCT04917861|142851530|OTHER||GMR|6.804|||||TWO_SIDED|95.0|3.928|11.784|||||GMR (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||11.784|3.928|
71667637|NCT04917861|142851531|OTHER||percentage difference|76.69|||||TWO_SIDED|95.0|69.1|82.68|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||82.68|69.10|
71667638|NCT04917861|142851531|OTHER||percentage difference|77.8|||||TWO_SIDED|95.0|70.29|83.67|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||83.67|70.29|
71667639|NCT04917861|142851531|OTHER||percentage difference|35.58|||||TWO_SIDED|95.0|27.47|43.74|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||43.74|27.47|
71667640|NCT04917861|142851531|OTHER||percentage difference|86.11|||||TWO_SIDED|95.0|76.25|92.29|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||92.29|76.25|
71667641|NCT04917861|142851531|OTHER||percentage difference|87.65|||||TWO_SIDED|95.0|78.71|93.17|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||93.17|78.71|
71667642|NCT04917861|142851531|OTHER||percentage difference|20.43|||||TWO_SIDED|95.0|13.47|29.75|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||29.75|13.47|
71667643|NCT04917861|142851531|OTHER||percentage difference|67.72|||||TWO_SIDED|95.0|55.69|77.07|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.07|55.69|
71667644|NCT04917861|142851531|OTHER||percentage difference|67.81|||||TWO_SIDED|95.0|55.36|77.44|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||77.44|55.36|
71667645|NCT04917861|142851531|OTHER||percentage difference|57.53|||||TWO_SIDED|95.0|43.81|69.08|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||69.08|43.81|
71667646|NCT04917861|142851532|OTHER||percentage difference|75.46|||||TWO_SIDED|95.0|68.12|81.49|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.49|68.12|
71667647|NCT04917861|142851532|OTHER||percentage difference|75.32|||||TWO_SIDED|95.0|67.94|81.38|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for all participants|||81.38|67.94|
71667648|NCT04917861|142851532|OTHER||percentage difference|31.29|||||TWO_SIDED|95.0|24.23|38.96|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for all participants|||38.96|24.23|
71667649|NCT04917861|142851532|OTHER||percentage difference|77.78|||||TWO_SIDED|95.0|66.87|85.85|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||85.85|66.87|
71667650|NCT04917861|142851532|OTHER||percentage difference|82.72|||||TWO_SIDED|95.0|73.02|89.43|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||89.43|73.02|
71667651|NCT04917861|142851532|OTHER||percentage difference|9.68|||||TWO_SIDED|95.0|4.63|17.41|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-negative participants|||17.41|4.63|
71667652|NCT04917861|142851532|OTHER||percentage difference|72.39|||||TWO_SIDED|95.0|61.56|80.83|||||Percentage Difference (mRNA-1893 Low Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||80.83|61.56|
71667653|NCT04917861|142851532|OTHER||percentage difference|67.29|||||TWO_SIDED|95.0|55.72|76.78|||||Percentage Difference (mRNA-1893 High Dose \[2-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||76.78|55.72|
71667654|NCT04917861|142851532|OTHER||percentage difference|63.35|||||TWO_SIDED|95.0|50.75|74.0|||||Percentage Difference (mRNA-1893 High Dose \[1-Dose Regimen\] vs. Placebo) for flavivirus-positive participants|||74.00|50.75|
71677055|NCT00746564|142872549|SUPERIORITY_OR_OTHER||percentage of interpretable recording|92.3|||||TWO_SIDED|95.0|91.9|92.6||||||"The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:~Duration of interpretable recording / Total duration of recording time"||92.6|91.9|
71677056|NCT00746564|142872550|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|86.2|||||TWO_SIDED|95.0|79.4|91.0||||||||91.0|79.4|
71677057|NCT00746564|142872551|SUPERIORITY_OR_OTHER||percentage of inappropriate recordings|63.2|||||TWO_SIDED|95.0|48.1|76.2||||||||76.2|48.1|
71667655|NCT06389487|142851546|NON_INFERIORITY|Non-Inferiority (NI) was to be demonstrated if the upper limit of the 95% confidence interval (CI) of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was less than or equal to (≤) 1.5.|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||0.81|0.64|
71667656|NCT06389487|142851547|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-9.33|||||TWO_SIDED|95.0|-14.55|-4.1|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration.||-4.10|-14.55|
71667657|NCT06389487|142851548|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group GMT ratio between Part A:RSV-OA Group over Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤1.5.|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.65|0.82|||||The comparison is done using the group ratio of adjusted GMT (Part A:RSV-OA/ Part A:RSV-A-AIR) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||0.82|0.65|
71667658|NCT06389487|142851549|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 95% CI of the group SRR difference between Part A:RSV-OA Group and Part A:RSV-A-AIR Group at 1 month post RSVPreF3 OA vaccine administration was ≤10%.|Difference in percentage|-10.03|||||TWO_SIDED|95.0|-15.26|-4.8|||||The comparison is done using the difference of SRR (Part A:RSV-OA - Part A:RSV-A-AIR).|To demonstrate the non-inferiority of the humoral immune response in participants aged 18-49 YOA at increased risk for RSV disease (Part A:RSV-A-AIR Group) compared to older adults aged ≥60 YOA (Part A:RSV-OA Group) for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.||-4.80|-15.26|
71667659|NCT03713593|142851557|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.834|||||TWO_SIDED|95.0|0.712|0.978|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.978|0.712|
71667660|NCT03713593|142851558|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0227|TWO_SIDED|95.0|0.708|0.997|||Log Rank|Onesided p-value based on logrank test stratified by geographic region, portal vein invasion/extrahepatic spread/both AFP status,ECOG status.|Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.997|0.708|0.0227
71667661|NCT03713593|142851559|OTHER|Descriptive assessment|Difference in percentage|8.5|||||TWO_SIDED|95.0|2.8|14.2|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||14.2|2.8|
71667662|NCT03713593|142851562|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.66|0.93|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.93|0.66|
71667663|NCT03713593|142851563|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.68|0.94|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.94|0.68|
71780990|NCT02527161|143061622|SUPERIORITY|||||||0.0736|||||||ANOVA|||Change from 6 weeks to 3 months KOOS Symptoms||||0.0736
71780991|NCT02527161|143061622|SUPERIORITY|||||||0.4675|||||||ANOVA|||Change from 3 months to 6 months KOOS Symptoms||||0.4675
71780992|NCT02527161|143061622|SUPERIORITY|||||||0.0229|||||||ANOVA|||Change from 6 months to 1 year KOOS Symptoms||||0.0229
71780993|NCT02527161|143061622|SUPERIORITY|||||||0.9968|||||||ANOVA|||Change from 1 year to 2 year KOOS Symptoms||||0.9968
71780994|NCT02527161|143061622|SUPERIORITY|||||||0.7761|||||||ANOVA|||Change from 2 year to 5 year KOOS Symptoms||||0.7761
71780995|NCT02527161|143061623|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS ADL||||<0.0001
71780996|NCT02527161|143061623|SUPERIORITY|||||||0.0212|||||||ANOVA|||Change from 6 weeks to 3 months KOOS ADL||||0.0212
71780997|NCT02527161|143061623|SUPERIORITY|||||||0.7173|||||||ANOVA|||Change from 3 months to 6 months KOOS ADL||||0.7173
71780998|NCT02527161|143061623|SUPERIORITY|||||||0.1834|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.1834
71780999|NCT02527161|143061623|SUPERIORITY|||||||0.9957|||||||ANOVA|||Change from 1 year to 2 year KOOS ADL||||0.9957
71781000|NCT02527161|143061623|SUPERIORITY|||||||0.9999|||||||ANOVA|||Change from 6 months to 1 year KOOS ADL||||0.9999
71781001|NCT02527161|143061624|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS S\&R||||<0.0001
71667664|NCT03713593|142851564|OTHER|Descriptive assessment|Difference in percentage|6.7|||||TWO_SIDED|95.0|0.0|13.4|||||Based on Miettinen \& Nurminen method stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||13.4|0.0|
71667665|NCT03713593|142851567|OTHER|Descriptive assessment|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.61|0.88|||||Based on Cox model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, MPVI or extrahepatic spread or both, AFP and ECOG PS.|||0.88|0.61|
71667666|NCT04479852|142851595|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.133|TWO_SIDED|95.0|-4.1|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||0.5|-4.1|0.133
71667667|NCT04479852|142851596|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.059|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.0|-0.5|0.059
71667668|NCT04479852|142851597|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.159|TWO_SIDED|95.0|-2.7|0.4|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in HAM-D score from baseline.|||0.4|-2.7|0.159
71667669|NCT04479852|142851598|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.188|TWO_SIDED|95.0|-2.5|0.5|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in SDS score from baseline.|||0.5|-2.5|0.188
71667670|NCT04479852|142851599|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.091|TWO_SIDED|95.0|-2.0|0.2|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in QIDS score from baseline.|||0.2|-2.0|0.091
71748894|NCT03192176|143005299|SUPERIORITY||LSMean difference|11.8|STANDARD_ERROR_OF_MEAN|6.47||0.0689|TWO_SIDED|95.0|-0.92|24.53||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||24.53|-0.92|0.0689
71748895|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.6|STANDARD_ERROR_OF_MEAN|6.46||0.025|TWO_SIDED|95.0|1.84|27.27||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||27.27|1.84|0.0250
71781002|NCT02527161|143061624|SUPERIORITY|||||||0.0522|||||||ANOVA|||Change from 6 weeks to 3 months KOOS S\&R||||0.0522
71667671|NCT04479852|142851600|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.243|TWO_SIDED|95.0|-1.2|4.6|||Mixed Models Analysis||A positive difference favors the SP-624 treatment group, i.e., a greater increase in Q-LES-Q score from baseline.|||4.6|-1.2|0.243
71667672|NCT04479852|142851601|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.008|TWO_SIDED|95.0|-6.8|-1.0|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||-1.0|-6.8|.008
71667673|NCT04479852|142851602|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.8|-0.1|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||-0.1|-0.8|0.006
71781003|NCT02527161|143061624|SUPERIORITY|||||||0.1696|||||||ANOVA|||Change from 3 months to 6 months KOOS S\&R||||0.1696
71781004|NCT02527161|143061624|SUPERIORITY|||||||0.6942|||||||ANOVA|||Change from 6 months to 1 year KOOS S\&R||||0.6942
71781005|NCT02527161|143061624|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KOOS S\&R||||>0.9999
71667674|NCT04479852|142851603|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.134|TWO_SIDED|95.0|-0.8|6.3|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in MADRS score from baseline.|||6.3|-0.8|0.134
71667675|NCT04479852|142851604|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.437|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis||A negative difference favors the SP-624 treatment group, i.e., a greater reduction in CGI-S score from baseline.|||0.6|-0.3|0.437
71667676|NCT03071692|142851629|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.92|1.16||||||||1.16|0.92|
71667677|NCT03071692|142851630|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.92|1.2||||||||1.20|0.92|
71667678|NCT03071692|142851631|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.18||||||||1.18|0.89|
71667679|NCT03071692|142851632|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16||||||||1.16|0.93|
71667680|NCT03071692|142851633|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13||||||||1.13|0.93|
71667681|NCT03071692|142851634|SUPERIORITY||Event Rate Ration|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||||1.13|0.87|
71667682|NCT03071692|142851635|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.09||||||||1.09|0.69|
71667683|NCT03071692|142851636|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.95|1.41||||||||1.41|0.95|
71667684|NCT03071692|142851637|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.19||||||||1.19|0.69|
71667685|NCT03071692|142851638|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.14||||||||1.14|0.84|
71667686|NCT03071692|142851639|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.32||||||||1.32|0.83|
71667687|NCT03071692|142851640|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.75|1.26||||||TT Variant||1.26|0.75|
71667688|NCT03071692|142851640|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||CT Variant||1.47|0.96|
71667689|NCT03071692|142851640|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.69|1.39||||||CC Variant||1.39|0.69|
71667690|NCT03071692|142851641|SUPERIORITY|||||||0.13496|||||||ANCOVA|||||||0.13496
71667691|NCT03071692|142851642|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71667692|NCT03071692|142851643|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71667693|NCT03071692|142851644|SUPERIORITY|||||||0.96689|||||||ANCOVA|||||||0.96689
71667694|NCT03071692|142851645|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71667695|NCT03071692|142851646|SUPERIORITY|||||||0.09178|||||||ANCOVA|||||||0.09178
71781006|NCT02527161|143061624|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS S\&R||||>0.9999
71781007|NCT02527161|143061625|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KOOS QoL||||<0.0001
71781008|NCT02527161|143061625|SUPERIORITY|||||||0.0135|||||||ANOVA|||Change from 6 weeks to 3 months KOOS QoL||||0.0135
71781009|NCT02527161|143061625|SUPERIORITY|||||||0.0829|||||||ANOVA|||Change from 3 months to 6 months KOOS QoL||||0.0829
71667696|NCT03071692|142851647|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71667697|NCT03071692|142851648|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71667698|NCT03071692|142851649|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71667699|NCT00970593|142851670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|95.0|-1.79|0.29||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||0.29|-1.79|
71667700|NCT00970593|142851670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.543|||TWO_SIDED|95.0|-2.98|-0.83||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-0.83|-2.98|
71781010|NCT02527161|143061625|SUPERIORITY|||||||0.1729|||||||ANOVA|||Change from 6 months to 1 year KOOS QoL||||0.1729
71781011|NCT02527161|143061625|SUPERIORITY|||||||0.9687|||||||ANOVA|||Change from 1 year to 2 year KOOS QoL||||0.9687
71781012|NCT02527161|143061625|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year KOOS QoL||||>0.9999
71781013|NCT02527161|143061626|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 PCS||||<0.0001
71781014|NCT02527161|143061626|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 PCS||||<0.0001
71781015|NCT02527161|143061626|SUPERIORITY|||||||0.8189|||||||ANOVA|||Change from 3 months to 6 months SF-12 PCS||||0.8189
71781016|NCT02527161|143061626|SUPERIORITY|||||||0.9845|||||||ANOVA|||Change from 6 months to 1 year SF-12 PCS||||0.9845
71781017|NCT02527161|143061626|SUPERIORITY|||||||0.75|||||||ANOVA|||Change from 1 year to 2 year SF-12 PCS||||0.7500
71781018|NCT02527161|143061626|SUPERIORITY|||||||0.1376|||||||ANOVA|||Change from 2 year to 5 year SF-12 PCS||||0.1376
71781019|NCT02527161|143061627|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 week VAS Rest||||<0.0001
71781020|NCT02527161|143061627|SUPERIORITY|||||||0.0031|||||||ANOVA|||Change from 6 weeks to 3 months VAS Rest||||0.0031
71781021|NCT02527161|143061627|SUPERIORITY|||||||0.299|||||||ANOVA|||Change from 3 months to 6 months VAS Rest||||0.2990
71781022|NCT02527161|143061627|SUPERIORITY|||||||0.9832|||||||ANOVA|||Change from 6 months to 1 year VAS Rest||||0.9832
71781023|NCT02527161|143061627|SUPERIORITY|||||||0.9991|||||||ANOVA|||Change from 1 year to 2 year VAS Rest||||0.9991
71781024|NCT02527161|143061627|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year VAS Rest||||>0.9999
71781025|NCT02527161|143061628|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks VAS Mob||||<0.0001
71781026|NCT02527161|143061628|SUPERIORITY|||||||0.0062|||||||ANOVA|||Change from 6 weeks to 3 months VAS Mob||||0.0062
71781027|NCT02527161|143061628|SUPERIORITY|||||||0.373|||||||ANOVA|||Change from 3 months to 6 months VAS Mob||||0.3730
71781028|NCT02527161|143061628|SUPERIORITY|||||||0.8499|||||||ANOVA|||Change from 6 months to 1 year VAS Mob||||0.8499
71781029|NCT02527161|143061628|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year VAS Mob||||>0.9999
71781030|NCT02527161|143061628|SUPERIORITY|||||||0.9958|||||||ANOVA|||Change from 2 year to 5 year VAS Mob||||0.9958
71781031|NCT02527161|143061629|SUPERIORITY|||||||0.3493|||||||ANOVA|||Change from preoperative to 6 weeks SF-12 MCS||||0.3493
71781032|NCT02527161|143061629|SUPERIORITY|||||||0.48|||||||ANOVA|||Change from 6 weeks to 3 months SF-12 MCS||||0.4800
71781033|NCT02527161|143061629|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 3 months to 6 months SF-12 MCS||||>0.9999
71781034|NCT02527161|143061629|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 6 months to 1 year SF-12 MCS||||>0.9999
71781035|NCT02527161|143061629|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year SF-12 MCS||||>0.9999
71781036|NCT02527161|143061629|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 2 year to 5 year SF-12 MCS||||>0.9999
71781037|NCT02527161|143061630|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 6 weeks KSS Pain||||<0.0001
71781038|NCT02527161|143061630|SUPERIORITY|||||||0.9465|||||||ANOVA|||Change from 3 months to 6 months KSS Pain||||0.9465
71781039|NCT02527161|143061630|SUPERIORITY|||||||0.1215|||||||ANOVA|||Change from 6 months to 1 year KSS Pain||||0.1215
71781040|NCT02527161|143061630|SUPERIORITY|||||||0.9912|||||||ANOVA|||Change from 1 year to 2 years KSS Pain||||0.9912
71781041|NCT02527161|143061630|SUPERIORITY|||||||0.8952|||||||ANOVA|||Change from 2 year to 5 year KSS Pain||||0.8952
71781042|NCT02527161|143061631|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from preoperative to 3 months KSS Function||||<0.0001
71781043|NCT02527161|143061631|SUPERIORITY|||||||0.0266|||||||ANOVA|||Change from 3 months to 6 months KSS Function||||0.0266
71781044|NCT02527161|143061631|SUPERIORITY|||||||0.988|||||||ANOVA|||Change from 6 months to 1 year KSS Function||||0.9880
71781045|NCT02527161|143061631|SUPERIORITY|||||||0.9699|||||||ANOVA|||Change from 1 year to 2 years KSS Function||||0.9699
71781046|NCT02527161|143061631|SUPERIORITY|||||||0.8575|||||||ANOVA|||Change from 2 year to 5 years KSS Function||||0.8575
71781047|NCT02527161|143061632|SUPERIORITY|||||||0.8581|||||||ANOVA|||Change from preoperative to 3 months KSS Range of Motion||||0.8581
71781048|NCT02527161|143061632|SUPERIORITY|||||||0.7664|||||||ANOVA|||Change from 3 months to 6 months KSS Range of Motion||||0.7664
71781049|NCT02527161|143061632|SUPERIORITY|||||||0.7022|||||||ANOVA|||Change from 6 months to 1 year KSS Range of Motion||||0.7022
71781050|NCT02527161|143061632|SUPERIORITY||||||>|0.9999|||||||ANOVA|||Change from 1 year to 2 year KSS Range of Motion||||>0.9999
71781051|NCT02527161|143061632|SUPERIORITY|||||||0.2943|||||||ANOVA|||Change from 2 year to 5 year KSS Range of Motion||||0.2943
71781052|NCT02527161|143061633|SUPERIORITY|||||||0.0161|||||||ANOVA|||Change from 1 year to 2 year Forgotten Joint Score||||0.0161
71781053|NCT02527161|143061633|SUPERIORITY||||||<|0.0001|||||||ANOVA|||Change from 2 year to 5 year Forgotten Joint Score||||<0.0001
71667701|NCT00970593|142851670|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.15|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|95.0|-3.06|-1.24||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.24|-3.06|
71667702|NCT00970593|142851671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.37|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-3.52|-1.22||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-1.22|-3.52|
71667703|NCT00970593|142851671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.18|STANDARD_ERROR_OF_MEAN|0.495|||TWO_SIDED|95.0|-4.16|-2.2||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.20|-4.16|
71667704|NCT00970593|142851671|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.14|STANDARD_ERROR_OF_MEAN|0.437|||TWO_SIDED|95.0|-4.01|-2.28||||||The Mixed model used fixed effects of treatment, study day and treatment by study day interaction.||-2.28|-4.01|
71667705|NCT02543944|142851676|SUPERIORITY||Risk Ratio (RR)|-0.0944|STANDARD_ERROR_OF_MEAN|0.32||0.77|TWO_SIDED|95.0|-0.72|0.53|||Regression, Logistic|||||0.53|-0.72|0.77
71667706|NCT02543944|142851677|SUPERIORITY||Odds Ratio (OR)|0.3||||0.58|TWO_SIDED||||||Chi-squared|||||||0.58
71667707|NCT02543944|142851678|SUPERIORITY||Odds Ratio (OR)|0.16||||0.69|TWO_SIDED||||||Chi-squared|||||||0.69
71835259|NCT02201108|143175276|OTHER||Hazard Ratio (HR)|0.693|||||TWO_SIDED|95.0|0.37|1.296|||||Hazard ratio estimated using a Cox proportional-hazards model using treatment group, region, pubertal status, age, and number of relapses in the year prior to randomisation as covariates and with robust variance estimation.|||1.296|0.37|
71835260|NCT05215847|143175287|OTHER|Adverse event subject incidence and event frequency.|||||||||||||||||Adverse event subject incidence and event frequency.|||
71667708|NCT02543944|142851679|SUPERIORITY||Odds Ratio (OR)|0.96||||0.32|TWO_SIDED||||||Chi-squared|||||||0.32
71667709|NCT00629018|142851683|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Log Rank|||The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.||||0.01
71667710|NCT04090125|142851689|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.485|TWO_SIDED|95.0|-0.9|0.43|||Mixed Models Analysis|||||0.43|-0.90|0.485
71667711|NCT04090125|142851690|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0887|TWO_SIDED|95.0|-1.13|0.08|||Mixed Models Analysis|||||0.08|-1.13|0.0887
71667712|NCT04090125|142851691|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.296|TWO_SIDED|95.0|-0.05|0.13|||Mixed Models Analysis|||||0.13|-0.05|0.296
71667713|NCT04090125|142851692|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.094|TWO_SIDED|95.0|-0.15|0.01|||Mixed Models Analysis|||||0.01|-0.15|0.094
71667714|NCT04090125|142851693|SUPERIORITY||Mean Difference (Final Values)|3.85||||0.11|TWO_SIDED|95.0|-0.91|8.62|||Mixed Models Analysis|||||8.62|-0.91|0.11
71667715|NCT04090125|142851694|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.55|TWO_SIDED|95.0|-4.1|7.59|||Mixed Models Analysis|||||7.59|-4.10|0.55
71667716|NCT04090125|142851695|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.134|TWO_SIDED|95.0|-0.34|0.05|||Mixed Models Analysis|||||0.05|-0.34|0.134
71667717|NCT04090125|142851696|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.09|TWO_SIDED|95.0|-0.38|0.03|||Mixed Models Analysis|||||0.03|-0.38|0.09
71667718|NCT04090125|142851697|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.25|TWO_SIDED|95.0|-0.16|0.04|||Mixed Models Analysis|||||0.04|-0.16|0.25
71667719|NCT04090125|142851698|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.16|TWO_SIDED|95.0|-0.22|0.04|||Mixed Models Analysis|||||0.04|-0.22|0.16
71667720|NCT04090125|142851699|SUPERIORITY||Mean Difference (Final Values)|21.36||||0.167|TWO_SIDED|95.0|-9.29|52.02|||Mixed Models Analysis|||||52.02|-9.29|0.167
71667721|NCT04090125|142851700|SUPERIORITY||Mean Difference (Final Values)|25.15||||0.189|TWO_SIDED|95.0|-12.85|63.14|||Mixed Models Analysis|||||63.14|-12.85|0.189
71667722|NCT04090125|142851705|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.42|TWO_SIDED|95.0|-3.65|8.67|||Mixed Models Analysis|||Pain subscale||8.67|-3.65|0.42
71667723|NCT04090125|142851705|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.76|TWO_SIDED|95.0|-6.29|8.57|||Mixed Models Analysis|||Symptoms subscale||8.57|-6.29|0.76
71667724|NCT04090125|142851705|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.46|TWO_SIDED|95.0|-13.2|6.12|||Mixed Models Analysis|||Quality of life subscale||6.12|-13.20|0.46
71667725|NCT04090125|142851705|SUPERIORITY||Mean Difference (Final Values)|2.54||||0.22|TWO_SIDED|95.0|-1.61|6.69|||Mixed Models Analysis|||Function in daily life||6.69|-1.61|0.22
71667726|NCT04090125|142851706|SUPERIORITY||Mean Difference (Final Values)|1.43||||0.65|TWO_SIDED|95.0|-4.98|7.85|||Mixed Models Analysis|||Pain subscale||7.85|-4.98|0.65
71667727|NCT04090125|142851706|SUPERIORITY||Mean Difference (Final Values)|3.95||||0.32|TWO_SIDED|95.0|-3.93|11.83|||Mixed Models Analysis|||Symptoms subscale||11.83|-3.93|0.32
71667728|NCT04090125|142851706|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.77|TWO_SIDED|95.0|-9.61|12.89|||Mixed Models Analysis|||Quality of life||12.89|-9.61|0.77
71835261|NCT03830177|143175325|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71835262|NCT03830177|143175326|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71835263|NCT03830177|143175327|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71835264|NCT03830177|143175328|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71835265|NCT03830177|143175330|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71835266|NCT04143061|143175332|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|6.55|||||TWO_SIDED|95.0|2.03|11.08||||||Statistical analysis for Serogroup A||11.08|2.03|
71667729|NCT04090125|142851706|SUPERIORITY||Mean Difference (Final Values)|3.25||||0.19|TWO_SIDED|95.0|-1.67|8.17|||Mixed Models Analysis|||Function in daily life||8.17|-1.67|0.19
71748896|NCT03192176|143005299|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.51||0.0002|TWO_SIDED|95.0|11.54|37.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||37.17|11.54|0.0002
71748897|NCT03192176|143005299|SUPERIORITY||LSMean difference|29.6|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|16.6|42.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.57|16.60|<0.0001
71748898|NCT03192176|143005299|SUPERIORITY||LSMean difference|8.4|STANDARD_ERROR_OF_MEAN|6.59||0.2041|TWO_SIDED|95.0|-4.58|21.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||21.36|-4.58|0.2041
71748899|NCT03192176|143005299|SUPERIORITY||LSMean difference|18.4|STANDARD_ERROR_OF_MEAN|6.5||0.0049|TWO_SIDED|95.0|5.62|31.2||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||31.20|5.62|0.0049
71748900|NCT03192176|143005299|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.45||0.0015|TWO_SIDED|95.0|8.0|33.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||33.37|8.00|0.0015
71748901|NCT03192176|143005299|SUPERIORITY||LSMean difference|15.8|STANDARD_ERROR_OF_MEAN|6.66||0.0184|TWO_SIDED|95.0|2.68|28.89||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||28.89|2.68|0.0184
71748902|NCT03192176|143005299|SUPERIORITY||LSMean difference|12.8|STANDARD_ERROR_OF_MEAN|6.66||0.0551|TWO_SIDED|95.0|-0.28|25.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||25.93|-0.28|0.0551
71748903|NCT03192176|143005299|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.73||0.0002|TWO_SIDED|95.0|12.51|39.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||39.00|12.51|0.0002
71748904|NCT03192176|143005299|SUPERIORITY||LSMean difference|31.6|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|18.17|44.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||44.93|18.17|<0.0001
71781054|NCT02100514|143061634|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.9|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-54.0|-45.8|||MMRM|||Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-45.8|-54.0|<0.001
71667730|NCT04090125|142851707|SUPERIORITY||Mean Difference (Final Values)|-1.95||||0.191|TWO_SIDED|95.0|-4.92|1.01|||Mixed Models Analysis|||||1.01|-4.92|0.191
71748905|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|6.79||0.0367|TWO_SIDED|95.0|0.89|27.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||27.62|0.89|0.0367
71748906|NCT03192176|143005299|SUPERIORITY||LSMean difference|21.2|STANDARD_ERROR_OF_MEAN|6.7||0.0017|TWO_SIDED|95.0|7.99|34.34||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||34.34|7.99|0.0017
71748907|NCT03192176|143005299|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.65||0.0003|TWO_SIDED|95.0|11.29|37.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.44|11.29|0.0003
71748908|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.5|STANDARD_ERROR_OF_MEAN|6.45||0.0255|TWO_SIDED|95.0|1.78|27.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.15|1.78|0.0255
71748909|NCT03192176|143005299|SUPERIORITY||LSMean difference|15.3|STANDARD_ERROR_OF_MEAN|6.45||0.0186|TWO_SIDED|95.0|2.57|27.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||27.94|2.57|0.0186
71667731|NCT04090125|142851708|SUPERIORITY||Mean Difference (Final Values)|-5.45||||0.0004|TWO_SIDED|95.0|-8.28|-2.62|||Mixed Models Analysis|||||-2.62|-8.28|0.0004
71667732|NCT01342081|142851709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3|||ANCOVA|||||-1.3|-2.1|< 0.001
71667733|NCT01342081|142851709|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less.|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Non-inferiority was evaluated after superiority to tafluprost was confirmed.||0.1|-0.7|
71667734|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9326|||||TWO_SIDED|95.0|0.9048|0.9604||||||Time point: 0-2 hours||0.9604|0.9048|
71891489|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.026||0.4763|TWO_SIDED|95.0|-0.033|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.070|-0.033|0.4763
71891490|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1613|TWO_SIDED|95.0|-0.015|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.088|-0.015|0.1613
71891491|NCT01431287|143304563|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.026||0.4908|TWO_SIDED|95.0|-0.069|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.033|-0.069|0.4908
71667735|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9431|||||TWO_SIDED|95.0|0.9081|0.9782||||||Time point: 2-4 hours||0.9782|0.9081|
71891492|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.072|0.173||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.173|0.072|<0.0001
71891493|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.026||0.0154|TWO_SIDED|95.0|0.012|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.012|0.0154
71748910|NCT03192176|143005299|SUPERIORITY||LSMean difference|26.5|STANDARD_ERROR_OF_MEAN|6.52|<|0.0001|TWO_SIDED|95.0|13.71|39.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||39.36|13.71|<0.0001
71748911|NCT03192176|143005299|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.94|42.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.81|16.94|<0.0001
71748912|NCT03192176|143005299|SUPERIORITY||LSMean difference|13.9|STANDARD_ERROR_OF_MEAN|6.57||0.0347|TWO_SIDED|95.0|1.01|26.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||26.85|1.01|0.0347
71748913|NCT03192176|143005299|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.48||0.0008|TWO_SIDED|95.0|9.16|34.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.65|9.16|0.0008
71891494|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.08|0.181||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.181|0.080|<0.0001
71891495|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0012|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.134|0.033|0.0012
71667736|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9503|||||TWO_SIDED|95.0|0.9419|0.9857||||||Time point: 4-9 hours||0.9857|0.9419|
71748914|NCT03192176|143005299|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.43||0.0003|TWO_SIDED|95.0|10.75|36.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||36.04|10.75|0.0003
71748915|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.43||0.0221|TWO_SIDED|95.0|2.13|27.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.43|2.13|0.0221
71748916|NCT03192176|143005299|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|6.43||0.0087|TWO_SIDED|95.0|4.32|29.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||29.62|4.32|0.0087
71748917|NCT03192176|143005299|SUPERIORITY||LSMean difference|26.4|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|13.65|39.23||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||39.23|13.65|<0.0001
71667737|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9197|||||TWO_SIDED|95.0|0.8914|0.948||||||Time point: 0-2 hours||0.9480|0.8914|
71667738|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9349|||||TWO_SIDED|95.0|0.8986|0.9712||||||Time point: 2-4 hours||0.9712|0.8986|
71891496|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0061|TWO_SIDED|95.0|0.02|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.020|0.0061
71891497|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.026||0.7518|TWO_SIDED|95.0|-0.059|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.042|-0.059|0.7518
71667739|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9498|||||TWO_SIDED|95.0|0.919|0.9805||||||Time point: 4-9 hours||0.9805|0.9190|
71667740|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9412|||||TWO_SIDED|95.0|0.9102|0.9722||||||Time point: 0-2 hours||0.9722|0.9102|
71667741|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9419|||||TWO_SIDED|95.0|0.9041|0.9796||||||Time point: 2-4 hours||0.9796|0.9041|
71667742|NCT01608100|142851737|SUPERIORITY_OR_OTHER||Area Under the Curve|0.9449|||||TWO_SIDED|95.0|0.9046|0.9852||||||Time point: 4-9 hours||0.9852|0.9046|
71667743|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|7.0||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0004
71667744|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|2.31||||0.0004|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0004
71667745|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.0011|TWO_SIDED|95.0|1.59|5.95||Likelihood Ratio|Regression, Cox|||Hazard Ratio||5.95|1.59|0.0011
71667746|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|12.76|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71891498|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.026||0.0034|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0034
71667747|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|3.65|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71667748|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.21|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.21|<0.0001
71667749|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|7.17|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71667750|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|2.07|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71667751|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.54||||0.0002|TWO_SIDED|95.0|1.84|6.87||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.87|1.84|0.0002
71667752|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|12.83|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71667753|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|3.66|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71667754|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.68|||<|0.0001|TWO_SIDED|95.0|2.25|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|2.25|<0.0001
71667755|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|6.07||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||0.0020
71667756|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|2.09||||0.002|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||0.0020
71667757|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.95||||0.005|TWO_SIDED|95.0|1.41|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.05|1.41|0.0050
71667758|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|12.15|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier||||<0.0001
71667759|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Proportion Percentage|3.57|||<|0.0001|TWO_SIDED||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier||||<0.0001
71667760|NCT01608100|142851738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.55|||<|0.0001|TWO_SIDED|95.0|2.08|6.03||Likelihood Ratio|Regression, Cox|||Hazard Ratio||6.03|2.08|<0.0001
71667761|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|84.44|||||TWO_SIDED|95.0|75.28|91.23||||||Time point: 0-2 hours||91.23|75.28|
71667762|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.21|||||TWO_SIDED|83.81|83.81|97.09||||||Time point: 2-4 hours||97.09|83.81|
71667763|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.9|||||TWO_SIDED|95.0|86.34|97.99||||||Time point: 4-9 hours||97.99|86.34|
71667764|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|85.26|||||TWO_SIDED|95.0|76.51|91.7||||||Time point: 0-2 hours||91.70|76.51|
71667765|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|91.86|||||TWO_SIDED|95.0|83.95|96.66||||||Time point: 2-4 hours||96.66|83.95|
71667766|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|94.95|||||TWO_SIDED|95.0|88.61|98.34||||||Time point: 4-9 hours||98.34|88.61|
71667767|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|87.32|||||TWO_SIDED|95.0|77.3|94.04||||||Time point: 0-2 hours||94.04|77.30|
71667768|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|92.0|||||TWO_SIDED|95.0|83.4|97.01||||||Time point: 2-4 hours||97.01|83.40|
71667769|NCT01608100|142851739|SUPERIORITY_OR_OTHER||Percent Sensitivity|93.15|||||TWO_SIDED|95.0|84.74|97.74||||||Time point: 4-9 hours||97.74|84.74|
71667770|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|85.73|||||TWO_SIDED|95.0|83.18|88.03||||||Time point: 0-2 hours||88.03|83.18|
71667771|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|85.2|||||TWO_SIDED|95.0|82.66|87.5||||||Time point: 2-4 hours||87.50|82.66|
71667772|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|82.82|||||TWO_SIDED|95.0|79.99|85.4||||||Time point: 4-9 hours||85.40|79.99|
71667773|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|83.76|||||TWO_SIDED|95.0|81.12|86.17||||||Time point: 0-2 hours||86.17|81.12|
71667774|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|83.72|||||TWO_SIDED|95.0|81.09|86.11||||||Time point: 2-4 hours||86.11|81.09|
71667775|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|80.72|||||TWO_SIDED|95.0|77.82|83.39||||||Time point: 4-9 hours||83.39|77.82|
71667776|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|86.35|||||TWO_SIDED|95.0|83.79|88.63||||||Time point: 0-2 hours||88.63|83.79|
71667777|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|85.81|||||TWO_SIDED|95.0|83.31|88.07||||||Time point: 2-4 hours||88.07|83.31|
71667778|NCT01608100|142851740|SUPERIORITY_OR_OTHER||Percent Specificity|84.05|||||TWO_SIDED|95.0|81.31|86.54||||||Time point: 4-9 hours||86.54|81.31|
71667779|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.1|||||TWO_SIDED|95.0|96.82|98.95||||||Time point: 0-2 hours||98.95|96.82|
71667780|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.19|||||TWO_SIDED|95.0|98.25|99.7||||||Time point: 2-4 hours||99.70|98.25|
71667781|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.23|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
71667782|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.08|||||TWO_SIDED|95.0|96.81|98.95||||||Time point: 0-2 hours||98.95|96.81|
71667783|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.05|||||TWO_SIDED|95.0|98.05|99.62||||||Time point: 2-4 hours||99.62|98.05|
71667784|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.24|||||TWO_SIDED|95.0|98.22|99.75||||||Time point: 4-9 hours||99.75|98.22|
71667785|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|98.73|||||TWO_SIDED|95.0|97.61|99.42||||||Time point: 0-2 hours||99.42|97.61|
71667786|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.2|||||TWO_SIDED|95.0|98.27|99.71||||||Time point: 2-4 hours||99.71|98.27|
71667787|NCT01608100|142851741|SUPERIORITY_OR_OTHER||Negative Predictive Value|99.25|||||TWO_SIDED|95.0|98.26|99.76||||||Time point: 4-9 hours||99.76|98.26|
71667788|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|38.78|||||TWO_SIDED|95.0|31.92|45.98||||||Time point: 0-2 hours||45.98|31.92|
71667789|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.68|||||TWO_SIDED|95.0|29.03|42.76||||||Time point: 2-4 hours||42.76|29.03|
71667790|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.49|||||TWO_SIDED|95.0|29.99|43.38||||||Time point: 4-9 hours||43.38|29.99|
71667791|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|36.82|||||TWO_SIDED|95.0|30.43|43.56||||||Time point: 0-2 hours||43.56|30.43|
71667792|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.75|||||TWO_SIDED|95.0|29.43|42.45||||||Time point: 2-4 hours||42.45|29.43|
71667793|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|37.75|||||TWO_SIDED|95.0|31.71|44.09||||||Time point: 4-9 hours||44.09|31.71|
71667794|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.84|||||TWO_SIDED|95.0|28.7|43.47||||||Time point: 0-2 hours||43.47|28.70|
71667795|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.94|||||TWO_SIDED|95.0|29.16|43.16||||||Time point: 2-4 hours||43.16|29.16|
71667796|NCT01608100|142851742|SUPERIORITY_OR_OTHER||Positive Predictive Value|35.05|||||TWO_SIDED|95.0|28.36|42.21||||||Time point: 4-9 hours||42.21|28.36|
71667797|NCT03440840|142851743|SUPERIORITY||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|2.68||0.4|TWO_SIDED||||||Mixed Models Analysis|Estimated marginal means comparisons, Tukey adjustment||||||0.40
71667798|NCT03440840|142851744|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED|||||Estimated marginal means comparisons, Tukey adjustment|Mixed Models Analysis|||||||0.37
71667799|NCT03440840|142851745|SUPERIORITY||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|2.04||0.37|TWO_SIDED||||||Mixed Models Analysis|Comparison of estimated marginal means, Tukey adjustment for multiple comparisons||||||0.37
71667800|NCT03440840|142851746|SUPERIORITY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|2.77||0.61|TWO_SIDED||||||Mixed Models Analysis||Differences between estimated marginal means, Tukey correction for multiple comparisons.|||||0.61
71667801|NCT01349192|142851776|SUPERIORITY||Proportion Difference (Final Values)|0.56||||0.0005|TWO_SIDED|95.0|0.25|0.74||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.74|0.25|0.0005
71667802|NCT01349192|142851776|SUPERIORITY||Proportion Difference (Final Values)|0.525||||0.0004|TWO_SIDED|95.0|0.23|0.8||Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.|||0.80|0.23|0.0004
71667803|NCT01349192|142851777|SUPERIORITY||Proportion Difference (Final Values)|0.09||||0.5463|TWO_SIDED|95.0|-0.18|0.34||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.34|-0.18|0.5463
71667804|NCT01349192|142851778|SUPERIORITY||Mean Difference (Final Values)|-9.42||||0.3683|TWO_SIDED|95.0|-30.3|11.47||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.|||11.47|-30.3|0.3683
71891499|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0209|TWO_SIDED|95.0|0.009|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.110|0.009|0.0209
71835267|NCT04143061|143175332|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|21.67|||||TWO_SIDED|95.0|17.82|25.8||||||Statistical analysis for Serogroup C||25.80|17.82|
71835268|NCT04143061|143175332|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.08|||||TWO_SIDED|95.0|7.43|14.89||||||Statistical analysis for Serogroup Y||14.89|7.43|
71835269|NCT04143061|143175332|NON_INFERIORITY|The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction.|Difference in percentage of participants|11.01|||||TWO_SIDED|95.0|7.86|14.47||||||Statistical analysis for Serogroup W||14.47|7.86|
71835270|NCT03289039|143175346|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.98|TWO_SIDED|95.0|0.27|4.12|||Log Rank|||||4.12|0.27|0.98
71835271|NCT03289039|143175347|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.89|TWO_SIDED|95.0|0.24|2.81|||Log Rank|||||2.81|0.24|0.89
71835272|NCT04732494|143175362|SUPERIORITY|The primary endpoint ORR was tested at a 2-sided alpha of 0.05.|Risk Difference (RD)|9.9||||0.2114|TWO_SIDED|95.0|-5.4|25.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||25.3|-5.4|0.2114
71835273|NCT04732494|143175363|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.58|1.45|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.45|0.58|
71891500|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.026||0.0708|TWO_SIDED|95.0|-0.004|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.004|0.0708
71667805|NCT01349192|142851779|SUPERIORITY||Proportion Difference (Final Values)|-0.2||||0.1205|TWO_SIDED|95.0|-0.42|0.03||The a priori threshold for statistical significance was 0.05.|Chi-squared||Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.|||0.03|-0.42|0.1205
71667806|NCT03749330|142851792|EQUIVALENCE|test of difference between pre and post|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71835274|NCT04732494|143175364|OTHER||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-9.2|22.5|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|||22.5|-9.2|
71835275|NCT04732494|143175365|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.59|0.64|
71835276|NCT04732494|143175366|OTHER||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.71|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors (ECOG PS score \[0 vs 1\] and the number of organs with metastases \[≤ 1 vs ≥ 2\]).|||1.61|0.71|
71835277|NCT04732494|143175369|OTHER||Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-14.4|19.9|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Investigator||19.9|-14.4|
71835278|NCT04732494|143175369|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.7|21.8|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Disease Control Rate Assessed by the Independent Review Committee||21.8|-11.7|
71835279|NCT04732494|143175370|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-12.7|20.4|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Investigator||20.4|-12.7|
71835280|NCT04732494|143175370|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Mantel-Haenszel common risk difference stratified by the stratification factors (ECOG PS score \[0 vs 1\] and number of organs with metastases \[≤ 1 vs ≥ 2\]).|Analysis of Clinical Benefit Rate Assessed by the Independent Review Committee||21.0|-11.0|
71891501|NCT01431287|143304564|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.026||0.6148|TWO_SIDED|95.0|-0.038|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.064|-0.038|0.6148
71677058|NCT00986921|142872576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.05|TWO_SIDED|95.0|0.0|3.0|||t-test, 1 sided|Data was not distributed normally. After log transformation, the log values were distributed normally.||||3|0|0.05
71748918|NCT03192176|143005299|SUPERIORITY||LSMean difference|31.0|STANDARD_ERROR_OF_MEAN|6.56|<|0.0001|TWO_SIDED|95.0|18.13|43.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||43.94|18.13|<0.0001
71748919|NCT03192176|143005299|SUPERIORITY||LSMean difference|14.8|STANDARD_ERROR_OF_MEAN|6.55||0.0244|TWO_SIDED|95.0|1.92|27.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||27.70|1.92|0.0244
71748920|NCT03192176|143005299|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.46||0.0008|TWO_SIDED|95.0|9.21|34.62||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.62|9.21|0.0008
71748921|NCT03192176|143005299|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|6.41||0.0003|TWO_SIDED|95.0|10.63|35.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.83|10.63|0.0003
71748922|NCT03192176|143005299|SUPERIORITY||LSMean difference|9.8|STANDARD_ERROR_OF_MEAN|7.38||0.1871|TWO_SIDED|95.0|-4.77|24.3||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||24.30|-4.77|0.1871
71748923|NCT03192176|143005299|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|7.38||0.7552|TWO_SIDED|95.0|-12.23|16.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||16.83|-12.23|0.7552
71748924|NCT03192176|143005299|SUPERIORITY||LSMean difference|1.5|STANDARD_ERROR_OF_MEAN|7.61||0.8407|TWO_SIDED|95.0|-13.44|16.5||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||16.50|-13.44|0.8407
71781055|NCT02100514|143061635|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.2|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-36.1|-30.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-30.2|-36.1|<0.001
71748925|NCT03192176|143005299|SUPERIORITY||LSMean difference|7.2|STANDARD_ERROR_OF_MEAN|7.6||0.345|TWO_SIDED|95.0|-7.77|22.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||22.14|-7.77|0.3450
71748926|NCT03192176|143005299|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|7.66||0.455|TWO_SIDED|95.0|-9.34|20.8||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||20.80|-9.34|0.4550
71748927|NCT03192176|143005299|SUPERIORITY||LSMean difference|10.4|STANDARD_ERROR_OF_MEAN|7.64||0.1747|TWO_SIDED|95.0|-4.64|25.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||25.44|-4.64|0.1747
71748928|NCT03192176|143005299|SUPERIORITY||LSMean difference|4.4|STANDARD_ERROR_OF_MEAN|7.38||0.5476|TWO_SIDED|95.0|-10.08|18.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||18.97|-10.08|0.5476
71748929|NCT03192176|143005299|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|8.01||0.7954|TWO_SIDED|95.0|-13.69|17.84||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.84|-13.69|0.7954
71748930|NCT03192176|143005299|SUPERIORITY||LSMean differencce|1.3|STANDARD_ERROR_OF_MEAN|7.96||0.8731|TWO_SIDED|95.0|-14.41|16.95||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.95|-14.41|0.8731
71667807|NCT00114140|142851849|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Z-test|||Assuming exponential distribution of survival times, the null hypothesis was a 43% increase in median survival time (40.5 mo. to 57.9 mo.) and a 21% increase in 3-year survival rate (54% to 65%). Assuming 5% ineligibility, 72 patients were required to be accrued over 3 years with 3-years of follow-up resulting in 80% power and 1-sided 0.10 significance level. (N later increased to 135 to accommodate an additional separate analysis of O-6-Methylguanine-DNA Methyltransferase (MGMT) status.)||||<0.001
71667808|NCT00114140|142851851|SUPERIORITY||Hazard Ratio (HR)|3.52||||0.0006|TWO_SIDED|95.0|1.64|7.56||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Overall survival: The sample size was increased to 135 to ensure adequate power to detect a hazard ratio (HR) of 2.5 for MGMT status, at a 2-sided significance level of 0.05 with an MGMT prevalence rate of at least 30%||7.56|1.64|0.0006
71748931|NCT03192176|143005299|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|8.31||0.9689|TWO_SIDED|95.0|-16.68|16.03||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||16.03|-16.68|0.9689
71748932|NCT03192176|143005299|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|8.28||0.6378|TWO_SIDED|95.0|-12.4|20.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.21|-12.40|0.6378
71748933|NCT03192176|143005299|SUPERIORITY||LSMean differencce|1.6|STANDARD_ERROR_OF_MEAN|8.33||0.8503|TWO_SIDED|95.0|-14.82|17.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||17.97|-14.82|0.8503
71748934|NCT03192176|143005299|SUPERIORITY||LSMean difference|13.0|STANDARD_ERROR_OF_MEAN|8.37||0.1224|TWO_SIDED|95.0|-3.51|29.44||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||29.44|-3.51|0.1224
71748935|NCT03192176|143005299|SUPERIORITY||LSMean difference|7.1|STANDARD_ERROR_OF_MEAN|7.99||0.3743|TWO_SIDED|95.0|-8.62|22.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.85|-8.62|0.3743
71781056|NCT02100514|143061635|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-29.6|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-32.8|-26.3||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-26.3|-32.8|
71781057|NCT02100514|143061635|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-23.8|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|95.0|-27.0|-20.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-20.5|-27.0|
71667809|NCT00114140|142851851|SUPERIORITY||Hazard Ratio (HR)|3.06||||0.0007|TWO_SIDED|95.0|1.55|6.04||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Progression-free survival||6.04|1.55|0.0007
71667810|NCT04848480|142851890|NON_INFERIORITY|Non-inferiority was considered confirmed if the estimated treatment difference was below 0.3%.|Treatment difference|0.05||||0.0065|TWO_SIDED|95.0|-0.13|0.23|||ANCOVA|||Change from baseline in HbA1c after 26 weeks was analysed using ANCOVA model with treatment, region, HbA1c group at screening and pre-trial basal insulin treatment as fixed factors, and baseline response as covariate.||0.23|-0.13|0.0065
71667811|NCT02366689|142851951|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.04
71748936|NCT03192176|143005299|SUPERIORITY||LSMean difference|-7.9|STANDARD_ERROR_OF_MEAN|7.89||0.3173|TWO_SIDED|95.0|-23.44|7.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||7.63|-23.44|0.3173
71748937|NCT03192176|143005299|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.82||0.7905|TWO_SIDED|95.0|-17.48|13.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.32|-17.48|0.7905
71748938|NCT03192176|143005299|SUPERIORITY||LSMean difference|-7.2|STANDARD_ERROR_OF_MEAN|8.24||0.3804|TWO_SIDED|95.0|-23.46|8.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||8.98|-23.46|0.3804
71781058|NCT02100514|143061636|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.7|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-49.7|-41.7|||MMRM|||Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.7|-49.7|<0.001
71781059|NCT02100514|143061636|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.9|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.3|-36.5||||||Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.5|-45.3|
71667812|NCT02366689|142851952|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||< 0.001
71748939|NCT03192176|143005299|SUPERIORITY||LSMean difference|-5.6|STANDARD_ERROR_OF_MEAN|8.11||0.4905|TWO_SIDED|95.0|-21.58|10.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||10.38|-21.58|0.4905
71748940|NCT03192176|143005299|SUPERIORITY||LSMean difference|-12.6|STANDARD_ERROR_OF_MEAN|8.25||0.1289|TWO_SIDED|95.0|-28.83|3.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||3.68|-28.83|0.1289
71748941|NCT03192176|143005299|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|8.24||0.4398|TWO_SIDED|95.0|-9.86|22.61||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||22.61|-9.86|0.4398
71748942|NCT03192176|143005299|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|7.81||0.7921|TWO_SIDED|95.0|-17.45|13.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.33|-17.45|0.7921
71748943|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|7.28||0.009|TWO_SIDED|95.0|4.82|33.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|MMRM: Mixed Model Repeated Measures||Week 1||33.46|4.82|0.0090
71667813|NCT02366689|142851953|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71667814|NCT02366689|142851954|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.432
71667815|NCT02366689|142851955|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71667816|NCT02366689|142851956|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71748944|NCT03192176|143005300|SUPERIORITY||LSMean difference|27.0|STANDARD_ERROR_OF_MEAN|7.32||0.0003|TWO_SIDED|95.0|12.61|41.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||41.39|12.61|0.0003
71748945|NCT03192176|143005300|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.31|<|0.0001|TWO_SIDED|95.0|25.14|53.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||53.90|25.14|<0.0001
71748946|NCT03192176|143005300|SUPERIORITY||LSMean difference|44.8|STANDARD_ERROR_OF_MEAN|7.4|<|0.0001|TWO_SIDED|95.0|30.27|59.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||59.39|30.27|<0.0001
71748947|NCT03192176|143005300|SUPERIORITY||LSMean difference|12.2|STANDARD_ERROR_OF_MEAN|7.43||0.1019|TWO_SIDED|95.0|-2.43|26.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||26.79|-2.43|0.1019
71748948|NCT03192176|143005300|SUPERIORITY||LSMean difference|27.8|STANDARD_ERROR_OF_MEAN|7.31||0.0002|TWO_SIDED|95.0|13.45|42.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||42.22|13.45|0.0002
71667817|NCT03283566|142851958|EQUIVALENCE|Assuming a 20-30% difference in outcome (CP/G quotient) between study arms, which is equivalent to 0.08-0.12 CP/G difference and a 0.07 standard deviation, a sample size of 6 subjects (1:1 randomization) will detect a CP/G difference of at least 0.12, assuming 80% power, with a 0.05 significance level.||||||0.739|||||||ANOVA|||||||0.739
71667818|NCT04882241|142851961|OTHER||Hazard Ratio (HR)|0.92||||0.39528|TWO_SIDED|95.0|0.5|1.7||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.70|0.50|0.39528
71667819|NCT04882241|142851962|OTHER||Difference in Percentage|1.9||||0.33244|TWO_SIDED|95.0|-7.7|12.0|||Miettinen and Nurminen|Based on unstratified Miettinen \& Nurminen method||||12.0|-7.7|0.33244
71667820|NCT04882241|142851963|OTHER||Hazard Ratio (HR)|1.03||||0.52903|TWO_SIDED|95.0|0.48|2.22||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.22|0.48|0.52903
71667821|NCT04882241|142851968|OTHER||Hazard Ratio (HR)|0.83||||0.34632|TWO_SIDED|95.0|0.34|2.05||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.05|0.34|0.34632
71667822|NCT05262387|142851984|OTHER||Mean Difference (Final Values)|9.32||||0.0494|TWO_SIDED|90.0|1.52|17.1|||Mixed Models Analysis|||||17.1|1.52|0.0494
71667823|NCT05262387|142851984|OTHER||Mean Difference (Final Values)|14.1||||0.0028|TWO_SIDED|90.0|6.38|21.9|||Mixed Models Analysis|||||21.9|6.38|0.0028
71667824|NCT05262387|142851985|OTHER||Mean Difference (Final Values)|-44.5||||0.1998|TWO_SIDED|90.0|-102.0|12.8|||Mixed Models Analysis|||||12.8|-102|0.1998
71667825|NCT05262387|142851985|OTHER||Mean Difference (Final Values)|4.16||||0.9041|TWO_SIDED|90.0|-53.1|61.4|||Mixed Models Analysis|||||61.4|-53.1|0.9041
71667826|NCT02515331|142851988|SUPERIORITY||Mean Difference (Net)|-8.555|STANDARD_ERROR_OF_MEAN|2.9077||0.002|TWO_SIDED|95.0|-14.388|-2.722||1-sided p-value|Longitudinal repeated measures mixed eff|||||-2.722|-14.388|0.002
71748949|NCT03192176|143005300|SUPERIORITY||LSMean difference|29.5|STANDARD_ERROR_OF_MEAN|7.27|<|0.0001|TWO_SIDED|95.0|15.21|43.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 1||43.82|15.21|<0.0001
71667827|NCT02515331|142851988|SUPERIORITY||Mean Difference (Net)|-14.727|STANDARD_ERROR_OF_MEAN|3.0548|<|0.001|TWO_SIDED|95.0|-20.852|-8.602||1-sided p-value|Longitudinal repeated measures mixed eff|||||-8.602|-20.852|<0.001
71667828|NCT01339403|142852064|SUPERIORITY_OR_OTHER||Rate ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
71667829|NCT01339403|142852064|SUPERIORITY_OR_OTHER||Rate ratio|12.1|||<|0.001|TWO_SIDED|95.0|10.3|14.2|||Poisson Regression|||Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.2|10.3|<0.001
71667830|NCT01339403|142852064|SUPERIORITY_OR_OTHER||Rate ratio|3.4||||0.059|TWO_SIDED|95.0|1.0|12.3|||Poisson Regression|||Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.3|1.0|0.059
71667831|NCT01339403|142852064|SUPERIORITY_OR_OTHER||Rate ratio|1.7|||<|0.001|TWO_SIDED|95.0|1.5|1.8|||Poisson Regression|||Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.8|1.5|<0.001
71667832|NCT01339403|142852064|SUPERIORITY_OR_OTHER||Rate Ratio|166.1|||<|0.001|TWO_SIDED|95.0|123.4|223.5|||Poisson Regression|||AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||223.5|123.4|<0.001
71748950|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.9|STANDARD_ERROR_OF_MEAN|7.03||0.0049|TWO_SIDED|95.0|6.1|33.76||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||33.76|6.10|0.0049
71748951|NCT03192176|143005300|SUPERIORITY||LSMean difference|28.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|14.64|42.46||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||42.46|14.64|<0.0001
71667833|NCT01339403|142852065|SUPERIORITY_OR_OTHER||Rate ratio|1.4|||<|0.001|TWO_SIDED|95.0|1.3|1.5|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||1.5|1.3|<0.001
71667834|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|65.7|||<|0.001|TWO_SIDED|95.0|57.1|75.7|||Poisson Regression|||Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||75.7|57.1|<0.001
71667835|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|428.5|||<|0.001|TWO_SIDED|95.0|292.2|628.5|||Poisson Regression|||Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||628.5|292.2|<0.001
71667836|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|8.7|||<|0.001|TWO_SIDED|95.0|7.9|9.5|||Poisson Regression|||Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.5|7.9|<0.001
71667837|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|97.1|||<|0.001|TWO_SIDED|95.0|75.5|124.8|||Poisson Regression|||Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||124.8|75.5|<0.001
71667838|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|60.2|||<|0.001|TWO_SIDED|95.0|48.3|74.9|||Poisson Regression|||Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||74.9|48.3|<0.001
71667839|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|98.4|||<|0.001|TWO_SIDED|95.0|70.8|136.8|||Poisson Regression|||Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||136.8|70.8|<0.001
71667840|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|189.5|||<|0.001|TWO_SIDED|95.0|112.3|319.5|||Poisson Regression|||Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||319.5|112.3|<0.001
71667841|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|5.2|7.4|||Poisson Regression|||Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||7.4|5.2|<0.001
71748952|NCT03192176|143005300|SUPERIORITY||LSMean differencce|33.8|STANDARD_ERROR_OF_MEAN|7.05|<|0.0001|TWO_SIDED|95.0|19.96|47.69||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||47.69|19.96|<0.0001
71748953|NCT03192176|143005300|SUPERIORITY||LSMean difference|39.5|STANDARD_ERROR_OF_MEAN|7.16|<|0.0001|TWO_SIDED|95.0|25.4|53.58||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||53.58|25.40|<0.0001
71667842|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|594.5|||<|0.001|TWO_SIDED|95.0|146.5|2411.7|||Poisson Regression|||Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||2411.7|146.5|<0.001
71667843|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|10.6|||<|0.001|TWO_SIDED|95.0|7.8|14.4|||Poisson Regression|||Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||14.4|7.8|<0.001
71667844|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|51.5|||<|0.001|TWO_SIDED|95.0|30.3|87.5|||Poisson Regression|||Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||87.5|30.3|<0.001
71667845|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|6.2|||<|0.001|TWO_SIDED|95.0|3.0|12.9|||Poisson Regression|||Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||12.9|3.0|<0.001
71748954|NCT03192176|143005300|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|7.17||0.0146|TWO_SIDED|95.0|3.5|31.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||31.70|3.50|0.0146
71667846|NCT01339403|142852066|SUPERIORITY_OR_OTHER||Rate ratio|13.0|||<|0.0001|TWO_SIDED|95.0|7.4|23.1|||Poisson Regression|||Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||23.1|7.4|<0.0001
71748955|NCT03192176|143005300|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|7.06||0.0007|TWO_SIDED|95.0|10.21|38.0||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||38.00|10.21|0.0007
71748956|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.9|STANDARD_ERROR_OF_MEAN|7.03||0.0008|TWO_SIDED|95.0|10.05|37.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 2||37.70|10.05|0.0008
71748957|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.2|STANDARD_ERROR_OF_MEAN|7.46||0.002|TWO_SIDED|95.0|8.56|37.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||37.90|8.56|0.0020
71667847|NCT01339403|142852067|SUPERIORITY_OR_OTHER||Rate ratio|4.7|||<|0.001|TWO_SIDED|95.0|4.3|5.1|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.1|4.3|<0.001
71748958|NCT03192176|143005300|SUPERIORITY||LSMean difference|34.4|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|19.6|49.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||49.11|19.60|<0.0001
71667848|NCT01339403|142852068|SUPERIORITY_OR_OTHER||Rate ratio|7.0|||<|0.001|TWO_SIDED|95.0|6.0|8.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||8.2|6.0|<0.001
71667849|NCT01339403|142852069|SUPERIORITY_OR_OTHER||Rate ratio|8.3|||<|0.001|TWO_SIDED|95.0|7.1|9.6|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||9.6|7.1|<0.001
71748959|NCT03192176|143005300|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|20.96|50.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||50.32|20.96|<0.0001
71748960|NCT03192176|143005300|SUPERIORITY||LSMean difference|43.0|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|28.03|57.93||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||57.93|28.03|<0.0001
71748961|NCT03192176|143005300|SUPERIORITY||LSMean difference|25.4|STANDARD_ERROR_OF_MEAN|7.6||0.0009|TWO_SIDED|95.0|10.48|40.37||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||40.37|10.48|0.0009
71748962|NCT03192176|143005300|SUPERIORITY||LSMean difference|31.2|STANDARD_ERROR_OF_MEAN|7.48|<|0.0001|TWO_SIDED|95.0|16.49|45.9||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||45.90|16.49|<0.0001
71667850|NCT01339403|142852070|SUPERIORITY_OR_OTHER||Rate ratio|5.6|||<|0.001|TWO_SIDED|95.0|5.3|5.9|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||5.9|5.3|<0.001
71667851|NCT01339403|142852071|SUPERIORITY_OR_OTHER||Rate ratio|19.8|||<|0.001|TWO_SIDED|95.0|11.2|35.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.||35.2|11.2|<0.001
71667852|NCT03983980|142852072|SUPERIORITY||Risk Ratio (RR)|6.1|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71748963|NCT03192176|143005300|SUPERIORITY||LSMean difference|28.9|STANDARD_ERROR_OF_MEAN|7.44||0.0001|TWO_SIDED|95.0|14.24|43.52||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 3||43.52|14.24|0.0001
71748964|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|7.42||0.0021|TWO_SIDED|95.0|8.46|37.66||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||37.66|8.46|0.0021
71748965|NCT03192176|143005300|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|7.45|<|0.0001|TWO_SIDED|95.0|17.42|46.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||46.71|17.42|<0.0001
71748966|NCT03192176|143005300|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.73|45.91||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.91|16.73|<0.0001
71748967|NCT03192176|143005300|SUPERIORITY||LSMean difference|41.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED|95.0|26.95|56.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||56.68|26.95|<0.0001
71748968|NCT03192176|143005300|SUPERIORITY||LSMean difference|25.6|STANDARD_ERROR_OF_MEAN|7.54||0.0008|TWO_SIDED|95.0|10.77|40.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||40.43|10.77|0.0008
71748969|NCT03192176|143005300|SUPERIORITY||LSMean difference|31.3|STANDARD_ERROR_OF_MEAN|7.42|<|0.0001|TWO_SIDED|95.0|16.75|45.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||45.94|16.75|<0.0001
71748970|NCT03192176|143005300|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|7.39|<|0.0001|TWO_SIDED|95.0|14.91|43.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 4||43.97|14.91|<0.0001
71891502|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.164|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.114|0.215||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.215|0.114|<0.0001
71748971|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|7.05||0.0045|TWO_SIDED|95.0|6.31|34.06||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||34.06|6.31|0.0045
71748972|NCT03192176|143005300|SUPERIORITY||LSMean difference|30.6|STANDARD_ERROR_OF_MEAN|7.07|<|0.0001|TWO_SIDED|95.0|16.68|44.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||44.49|16.68|<0.0001
71748973|NCT03192176|143005300|SUPERIORITY||LSMean difference|29.1|STANDARD_ERROR_OF_MEAN|7.08|<|0.0001|TWO_SIDED|95.0|15.14|42.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||42.98|15.14|<0.0001
71748974|NCT03192176|143005300|SUPERIORITY||LSMean difference|40.1|STANDARD_ERROR_OF_MEAN|7.19|<|0.0001|TWO_SIDED|95.0|25.96|54.26||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||54.26|25.96|<0.0001
71748975|NCT03192176|143005300|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|7.15||0.0007|TWO_SIDED|95.0|10.28|38.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||38.42|10.28|0.0007
71748976|NCT03192176|143005300|SUPERIORITY||LSMean difference|26.7|STANDARD_ERROR_OF_MEAN|7.06||0.0002|TWO_SIDED|95.0|1.78|40.55||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||40.55|1.78|0.0002
71748977|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|7.03||0.001|TWO_SIDED|95.0|9.55|37.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 5||37.22|9.55|0.0010
71667853|NCT03983980|142852073|SUPERIORITY||Risk Ratio (RR)|6.53|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71667854|NCT03983980|142852074|SUPERIORITY||Risk Ratio (RR)|4.55|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71667855|NCT03983980|142852075|SUPERIORITY||Least squares mean difference|-4.32|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71667856|NCT03983980|142852076|SUPERIORITY||Risk Ratio (RR)|7.25|||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71667857|NCT01269918|142852109|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-5|-13|< 0.001
71667858|NCT01269918|142852109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.||-4|-13|< 0.001
71667859|NCT01269918|142852110|NON_INFERIORITY_OR_EQUIVALENCE|We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-1.1|-2.7|< 0.001
71748978|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.6||0.004|TWO_SIDED|95.0|6.13|32.11||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||32.11|6.13|0.0040
71835281|NCT04732494|143175371|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-8.4|11.9||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.9|-8.4|
71748979|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.8|STANDARD_ERROR_OF_MEAN|6.62||0.0004|TWO_SIDED|95.0|10.8|36.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.83|10.80|0.0004
71748980|NCT03192176|143005300|SUPERIORITY||LSMean difference|27.2|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.1|40.24||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||40.24|14.10|<0.0001
71748981|NCT03192176|143005300|SUPERIORITY||LSMean difference|35.6|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|95.0|22.34|48.88||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||48.88|22.34|<0.0001
71748982|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0032|TWO_SIDED|95.0|6.76|33.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||33.19|6.76|0.0032
71748983|NCT03192176|143005300|SUPERIORITY||LSMean difference|24.1|STANDARD_ERROR_OF_MEAN|6.64||0.0003|TWO_SIDED|95.0|11.02|37.13||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||37.13|11.02|0.0003
71667860|NCT01269918|142852110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.||-0.9|-2.8|< 0.001
71667861|NCT01269918|142852111|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority delta = 2 mg opioid|Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-5|-10|< 0.001
71667862|NCT01269918|142852111|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test||-3|-10|< 0.001
71667863|NCT01269918|142852112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-10.0|3.0|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.||3|-10|< 0.001
71748984|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.59||0.0005|TWO_SIDED|95.0|10.17|36.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 6||36.08|10.17|0.0005
71748985|NCT03192176|143005300|SUPERIORITY||LSMean difference|17.6|STANDARD_ERROR_OF_MEAN|6.82||0.0102|TWO_SIDED|95.0|4.2|31.04||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||31.04|4.20|0.0102
71748986|NCT03192176|143005300|SUPERIORITY||LSMean difference|25.9|STANDARD_ERROR_OF_MEAN|6.83||0.0002|TWO_SIDED|95.0|12.42|39.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.29|12.42|0.0002
71748987|NCT03192176|143005300|SUPERIORITY||LSMean difference|25.8|STANDARD_ERROR_OF_MEAN|6.87||0.0002|TWO_SIDED|95.0|12.29|39.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||39.33|12.29|0.0002
71748988|NCT03192176|143005300|SUPERIORITY||LSMean difference|36.3|STANDARD_ERROR_OF_MEAN|6.97|<|0.0001|TWO_SIDED|95.0|22.58|49.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||49.98|22.58|<0.0001
71667864|NCT01269918|142852113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.16|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.||0.5|-2.6|0.16
71667865|NCT01269918|142852114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.07|TWO_SIDED|95.0|-0.6|0.03|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.||0.03|-0.6|0.07
71667866|NCT01269918|142852115|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.009|TWO_SIDED|95.0|-1.0|-0.001|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.||-0.001|-1|0.009
71667867|NCT01269918|142852116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.||0.18|0.07|< 0.001
71667868|NCT01269918|142852117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12|||<|0.001|TWO_SIDED|95.0|0.07|0.19|||Regression, Cox|||Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.||0.19|0.07|< 0.001
71667869|NCT01269918|142852118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.022|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.||0.95|0.48|0.022
71667870|NCT01269918|142852119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.45|TWO_SIDED|95.0|0.81|1.62|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression||1.62|0.81|0.45
71667871|NCT01269918|142852120|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.91|TWO_SIDED|95.0|0.5|2.2|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.||2.2|0.5|0.91
71667872|NCT01269918|142852121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.16|TWO_SIDED|95.0|0.07|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.||1.7|0.07|0.16
71667873|NCT01269918|142852122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.||1.7|0.1|0.21
71667874|NCT04471428|142852149|SUPERIORITY|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens|Hazard Ratio (HR)|0.884||||0.3668|TWO_SIDED|95.0|0.676|1.156|||Log Rank||Hazard ratio was estimated by Cox regression model.|||1.156|0.676|0.3668
71781060|NCT02100514|143061636|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.5|STANDARD_ERROR_OF_MEAN|2.17|||TWO_SIDED|95.0|-36.7|-28.2||||||Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.2|-36.7|
71667875|NCT04471428|142852149|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.4709|TWO_SIDED|95.0|0.696|1.182|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.182|0.696|0.4709
71667876|NCT04471428|142852150|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0079|TWO_SIDED|95.0|0.585|0.923|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors include histology, and prior NSCLC treatment regimens||0.923|0.585|0.0079
71667877|NCT04471428|142852150|SUPERIORITY||Hazard Ratio (HR)|0.731||||0.0061|TWO_SIDED|95.0|0.583|0.915|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified analysis||0.915|0.583|0.0061
71667878|NCT04471428|142852151|SUPERIORITY||Difference in Response Rates|-1.51||||0.6846|TWO_SIDED|95.0|-8.85|5.84|||Cochran-Mantel-Haenszel||95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||5.84|-8.85|0.6846
71667879|NCT04471428|142852151|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.47|1.63|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Stratified analysis; stratification factors- histology, prior NSCLC treatment regimens||1.63|0.47|
71667880|NCT04471428|142852151|SUPERIORITY||Difference in Response Rates|-1.51||||0.7216|TWO_SIDED|95.0|-8.85|5.84|||Chi-squared, Corrected||95% CIs was computed using the Wald method.|Unstratified Analysis||5.84|-8.85|0.7216
71667881|NCT04471428|142852151|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.47|1.62|||||Odds ratios were estimated by logistic regression. 95% CIs was computed using the Wald method.|Unstratified Analysis||1.62|0.47|
71667882|NCT04471428|142852153|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.27|TWO_SIDED|95.0|0.59|1.16|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis: Stratification factors include histology, and prior NSCLC treatment regimens||1.16|0.59|0.2700
71667883|NCT04471428|142852153|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3031|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.17|0.60|0.3031
71667884|NCT04471428|142852154|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2408|TWO_SIDED|95.0|0.86|1.79|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratification factors include histology, and prior NSCLC treatment regimens||1.79|0.86|0.2408
71667885|NCT04471428|142852154|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.1992|TWO_SIDED|95.0|0.88|1.81|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||1.81|0.88|0.1992
71667886|NCT04471428|142852155|SUPERIORITY||Difference in Event Free Rate|15.85||||0.0014|TWO_SIDED|95.0|6.12|25.59|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 6 months||25.59|6.12|0.0014
71667887|NCT04471428|142852155|SUPERIORITY||Difference in Event Free Rate|6.32||||0.0719|TWO_SIDED|95.0|-0.56|13.21|||z-test||The 95% CI for the difference in PFS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||13.21|-0.56|0.0719
71667888|NCT04471428|142852156|SUPERIORITY||Difference in Event Free Rate|-0.85||||0.8767|TWO_SIDED|95.0|-11.63|9.92|||z-test||The 95% CI for the difference in OS rates were estimated using the normal approximation method, with standard errors computed using the Greenwood method.|At 1 year||9.92|-11.63|0.8767
71667889|NCT00129545|142852168|NON_INFERIORITY_OR_EQUIVALENCE|The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.|Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.42|1.07|||||Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals|||1.07|0.42|
71667890|NCT02969044|142852179|SUPERIORITY||Mean Difference (Net)|-9.25|||<|0.001|TWO_SIDED|95.0|-14.75|-3.79|||ANCOVA|||||-3.79|-14.75|<0.001
71667891|NCT00262028|142852206|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A||44|29|
71667892|NCT00262028|142852206|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C||26|12|
71667893|NCT00262028|142852206|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W||29|17|
71667894|NCT00262028|142852206|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> -10% against each serogroup|Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y||38|25|
71667895|NCT00262028|142852206|SUPERIORITY_OR_OTHER||Vaccine group difference|37.0|||||TWO_SIDED|95.0|29.0|44.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||44|29|
71667896|NCT00262028|142852206|SUPERIORITY_OR_OTHER||Vaccine group difference|19.0|||||TWO_SIDED|95.0|12.0|26.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||26|12|
71667897|NCT00262028|142852206|SUPERIORITY_OR_OTHER||Vaccine group difference|23.0|||||TWO_SIDED|95.0|17.0|29.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||29|17|
71891503|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.026||0.0064|TWO_SIDED|95.0|0.02|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.020|0.0064
71667898|NCT00262028|142852206|SUPERIORITY_OR_OTHER||Vaccine group difference|31.0|||||TWO_SIDED|95.0|25.0|38.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \> 0% against each serogroup"||38|25|
71891504|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.152|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.102|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.203|0.102|<0.0001
71667899|NCT01184079|142852231|NON_INFERIORITY_OR_EQUIVALENCE|"Sample size: (1 + 1/u)(Zα + Zβ)2 σ2 /\[log (RGMT) -δ0\] u= ratio of the size of the Standard schedule to Alternate schedule groups (u =1, for equal size groups); one-sided alpha (0.025)/4 for multiplicity of serotypes. Average log-transformed and geometric mean titers (GMTs) with a two-sided 95% confidence interval of the ratio of the GMTs were used.~Non-inferiority is determined if upper bound GMT ratio of standard group to alternate group \< 1.5."|largest upper bound GMT ratio|0.82|||||||||||||Non-inferiority is determined if upper bound GMT ratio of standard 6 month group to alternate 12 month group \< 1.5.|The primary endpoint would demonstrate noninferiority if the upper bound of the 95% two-sided confidence interval (CI) of the ratio of GMT for Standard schedule group divided by that of Alternate schedule group is \<1.5.||||
71667900|NCT01184079|142852233|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Chi-squared|||null hypothsesis: no difference in proportion of side effects reported between groups||||0.26
71667901|NCT00143390|142852237|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.007|||||TWO_SIDED|95.0|0.771|1.317|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.317|0.771|
71748989|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.6|STANDARD_ERROR_OF_MEAN|6.94||0.0031|TWO_SIDED|95.0|7.0|34.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||34.29|7.00|0.0031
71748990|NCT03192176|143005300|SUPERIORITY||LSMean difference|22.9|STANDARD_ERROR_OF_MEAN|6.85||0.0009|TWO_SIDED|95.0|9.43|36.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.38|9.43|0.0009
71748991|NCT03192176|143005300|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.8||0.0009|TWO_SIDED|95.0|9.42|36.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 7||36.19|9.42|0.0009
71748992|NCT03192176|143005300|SUPERIORITY||LSMean difference|13.8|STANDARD_ERROR_OF_MEAN|6.71||0.0408|TWO_SIDED|95.0|0.58|26.97||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||26.97|0.58|0.0408
71748993|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.0|STANDARD_ERROR_OF_MEAN|6.72||0.0031|TWO_SIDED|95.0|6.77|33.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||33.21|6.77|0.0031
71748994|NCT03192176|143005300|SUPERIORITY||LSMean difference|22.1|STANDARD_ERROR_OF_MEAN|6.76||0.0012|TWO_SIDED|95.0|8.8|35.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||35.40|8.80|0.0012
71748995|NCT03192176|143005300|SUPERIORITY||LSMean difference|29.9|STANDARD_ERROR_OF_MEAN|6.87|<|0.0001|TWO_SIDED|95.0|16.39|43.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||43.42|16.39|<0.0001
71748996|NCT03192176|143005300|SUPERIORITY||LSMean difference|14.9|STANDARD_ERROR_OF_MEAN|6.84||0.0303|TWO_SIDED|95.0|1.42|28.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||28.32|1.42|0.0303
71891505|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0035|TWO_SIDED|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.126|0.025|0.0035
71748997|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.75||0.004|TWO_SIDED|95.0|6.3|32.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.87|6.30|0.0040
71748998|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.5|STANDARD_ERROR_OF_MEAN|6.71||0.0038|TWO_SIDED|95.0|6.34|32.73||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 8||32.73|6.34|0.0038
71748999|NCT03192176|143005300|SUPERIORITY||LSMean difference|16.0|STANDARD_ERROR_OF_MEAN|6.45||0.0137|TWO_SIDED|95.0|3.29|28.68||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||28.68|3.29|0.0137
71749000|NCT03192176|143005300|SUPERIORITY||LSMean difference|18.1|STANDARD_ERROR_OF_MEAN|6.45||0.0052|TWO_SIDED|95.0|5.44|30.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.82|5.44|0.0052
71781061|NCT02100514|143061637|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-45.0|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.9|-41.1|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-41.1|-48.9|<0.001
71749001|NCT03192176|143005300|SUPERIORITY||LSMean difference|22.6|STANDARD_ERROR_OF_MEAN|6.5||0.0006|TWO_SIDED|95.0|9.81|35.39||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||35.39|9.81|0.0006
71749002|NCT03192176|143005300|SUPERIORITY||LSMean difference|29.4|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|16.41|42.32||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||42.32|16.41|<0.0001
71749003|NCT03192176|143005300|SUPERIORITY||LSMean difference|13.7|STANDARD_ERROR_OF_MEAN|6.57||0.0378|TWO_SIDED|95.0|0.78|26.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||26.63|0.78|0.0378
71667902|NCT00143390|142852238|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.059|||||TWO_SIDED|95.0|0.816|1.374|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method||1.374|0.816|
71667903|NCT03417687|142852243|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-14.7%, +14.7%).|Mean Difference (Net)|1.4|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-0.75|3.6||||||The primary efficacy analysis tested the mean difference in the predicted percentage of remaining pulmonary function as measured by 129Xe MRI relative to the value as measured by 133Xe scintigraphy (reference standard) if a pre-defined section of lung were resected.||3.60|-0.75|
71667904|NCT03417687|142852245|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|3.71|STANDARD_DEVIATION|4.39|||TWO_SIDED|95.0|2.12|5.29||||||||5.29|2.12|
71749004|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.49||0.002|TWO_SIDED|95.0|7.31|32.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||32.85|7.31|0.002
71749005|NCT03192176|143005300|SUPERIORITY||LSMean difference|17.4|STANDARD_ERROR_OF_MEAN|6.44||0.0071|TWO_SIDED|95.0|4.77|30.09||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 9||30.09|4.77|0.0071
71749006|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.7|STANDARD_ERROR_OF_MEAN|6.63||0.002|TWO_SIDED|95.0|7.61|33.71||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||33.71|7.61|0.0020
71749007|NCT03192176|143005300|SUPERIORITY||LSMean difference|18.7|STANDARD_ERROR_OF_MEAN|6.63||0.005|TWO_SIDED|95.0|5.68|31.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||31.79|5.68|0.0050
71749008|NCT03192176|143005300|SUPERIORITY||LSMean difference|24.4|STANDARD_ERROR_OF_MEAN|6.71||0.0003|TWO_SIDED|95.0|11.2|37.6||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||37.60|11.20|0.0003
71749009|NCT03192176|143005300|SUPERIORITY||LSMean difference|32.1|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|18.77|45.42||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||45.42|18.77|<0.0001
71749010|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.1|STANDARD_ERROR_OF_MEAN|6.76||0.005|TWO_SIDED|95.0|5.79|32.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Wek 10||32.38|5.79|0.0050
71667905|NCT03417687|142852246|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-0.476|1.26||||||||1.26|-0.476|
71749011|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.1|STANDARD_ERROR_OF_MEAN|6.68||0.0006|TWO_SIDED|95.0|9.95|36.22||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||36.22|9.95|0.0006
71749012|NCT03192176|143005300|SUPERIORITY||LSMean difference|22.8|STANDARD_ERROR_OF_MEAN|6.62||0.0006|TWO_SIDED|95.0|9.79|35.85||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 10||35.85|9.79|0.0006
71749013|NCT03192176|143005300|SUPERIORITY||LSMean difference|18.5|STANDARD_ERROR_OF_MEAN|6.32||0.0036|TWO_SIDED|95.0|6.11|30.98||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||30.98|6.11|0.0036
71749014|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.2|STANDARD_ERROR_OF_MEAN|6.32||0.0015|TWO_SIDED|95.0|7.77|32.65||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.65|7.77|0.0015
71749015|NCT03192176|143005300|SUPERIORITY||LSMean difference|25.0|STANDARD_ERROR_OF_MEAN|6.39||0.0001|TWO_SIDED|95.0|12.41|37.57||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||37.57|12.41|0.0001
71749016|NCT03192176|143005300|SUPERIORITY||LSMean difference|29.8|STANDARD_ERROR_OF_MEAN|6.45|<|0.0001|TWO_SIDED|95.0|17.12|42.49||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||42.49|17.12|<0.0001
71749017|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.6|STANDARD_ERROR_OF_MEAN|6.43||0.0026|TWO_SIDED|95.0|6.9|32.21||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||32.21|6.90|0.0026
71749018|NCT03192176|143005300|SUPERIORITY||LSMean difference|23.4|STANDARD_ERROR_OF_MEAN|6.36||0.0003|TWO_SIDED|95.0|10.92|35.94||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||35.94|10.92|0.0003
71891506|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.026||0.0233|TWO_SIDED|95.0|0.008|0.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.109|0.008|0.0233
71667906|NCT03417687|142852247|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|1.35|STANDARD_DEVIATION|3.22|||TWO_SIDED|95.0|0.184|2.505||||||||2.505|0.184|
71749019|NCT03192176|143005300|SUPERIORITY||LSMean difference|21.7|STANDARD_ERROR_OF_MEAN|6.3||0.0006|TWO_SIDED|95.0|9.34|34.14||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 11||34.14|9.34|0.0006
71749020|NCT03192176|143005300|SUPERIORITY||LSMean difference|19.3|STANDARD_ERROR_OF_MEAN|6.37||0.0026|TWO_SIDED|95.0|6.78|31.83||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||31.83|6.78|0.0026
71749021|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.8|STANDARD_ERROR_OF_MEAN|6.36||0.0012|TWO_SIDED|95.0|8.29|33.33||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||33.33|8.29|0.0012
71749022|NCT03192176|143005300|SUPERIORITY||LSMean difference|25.1|STANDARD_ERROR_OF_MEAN|6.44||0.0001|TWO_SIDED|95.0|12.48|37.82||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||37.82|12.48|0.0001
71749023|NCT03192176|143005300|SUPERIORITY||LSMean difference|31.9|STANDARD_ERROR_OF_MEAN|6.5|<|0.0001|TWO_SIDED|95.0|19.11|44.67||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||44.67|19.11|<0.0001
71667907|NCT03417687|142852248|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-0.96|STANDARD_DEVIATION|3.16|||TWO_SIDED|95.0|-2.101|0.181||||||||0.181|-2.101|
71667908|NCT03417687|142852249|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-2.721|STANDARD_DEVIATION|3.82|||TWO_SIDED|95.0|-4.096|-1.345||||||||-1.345|-4.096|
71667909|NCT03417687|142852250|EQUIVALENCE|The 2 methods were considered equivalent if the 95% confidence interval for the mean within subject difference between 129Xe MRI and 133Xe scintigraphy measurements was contained within the equivalence margin (-5.0%, +5.0%).|Mean Difference (Final Values)|-1.76|STANDARD_DEVIATION|3.96|||TWO_SIDED|95.0|-3.192|-0.335||||||||-0.335|-3.192|
71749024|NCT03192176|143005300|SUPERIORITY||LSMean difference|20.1|STANDARD_ERROR_OF_MEAN|6.48||0.0021|TWO_SIDED|95.0|7.32|32.81||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||32.81|7.32|0.0021
71749025|NCT03192176|143005300|SUPERIORITY||LSMean difference|22.7|STANDARD_ERROR_OF_MEAN|6.4||0.0004|TWO_SIDED|95.0|10.1|35.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||35.29|10.10|0.0004
71749026|NCT03192176|143005300|SUPERIORITY||LSMean difference|21.9|STANDARD_ERROR_OF_MEAN|6.34||0.0006|TWO_SIDED|95.0|9.42|34.38||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 12||34.38|9.42|0.0006
71749027|NCT03192176|143005300|SUPERIORITY||LSMean difference|17.0|STANDARD_ERROR_OF_MEAN|7.82||0.0304|TWO_SIDED|95.0|1.62|32.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.40|1.62|0.0304
71749028|NCT03192176|143005300|SUPERIORITY||LSMean difference|6.8|STANDARD_ERROR_OF_MEAN|7.82||0.3857|TWO_SIDED|95.0|-8.6|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMMRM|||Week 13||22.19|-8.60|0.3857
71891507|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.026||0.6413|TWO_SIDED|95.0|-0.039|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.063|-0.039|0.6413
71667910|NCT00681031|142852254|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptability was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) on the Geometric Mean Fold Rise (CMFR) from pre-vaccination to 4 weeks postvaccination is \>1.4.|GMFR|3.1|||||TWO_SIDED|95.0|2.6|3.8|||||GMFR = GMT postdose divided by GMT predose|||3.8|2.6|
71749029|NCT03192176|143005300|SUPERIORITY||LSMean difference|7.5|STANDARD_ERROR_OF_MEAN|8.06||0.3497|TWO_SIDED|95.0|-8.31|23.4||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||23.40|-8.31|0.3497
71749030|NCT03192176|143005300|SUPERIORITY||LSMean difference|10.9|STANDARD_ERROR_OF_MEAN|8.05||0.1771|TWO_SIDED|95.0|-4.95|26.75||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|LSMean difference|||Week 13||26.75|-4.95|0.1771
71749031|NCT03192176|143005300|SUPERIORITY||LSMean difference|16.3|STANDARD_ERROR_OF_MEAN|8.1||0.0444|TWO_SIDED|95.0|0.41|32.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||32.29|0.41|0.0444
71749032|NCT03192176|143005300|SUPERIORITY||LSMean difference|11.7|STANDARD_ERROR_OF_MEAN|8.1||0.15|TWO_SIDED|95.0|-4.25|27.63||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||27.63|-4.25|0.1500
71749033|NCT03192176|143005300|SUPERIORITY||LSMean difference|3.9|STANDARD_ERROR_OF_MEAN|7.83||0.6196|TWO_SIDED|95.0|-11.51|19.29||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 13||19.29|-11.51|0.6196
71749034|NCT03192176|143005300|SUPERIORITY||LSMean difference|9.4|STANDARD_ERROR_OF_MEAN|8.48||0.2664|TWO_SIDED|95.0|-7.25|26.15||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||26.15|-7.25|0.2664
71749035|NCT03192176|143005300|SUPERIORITY||LSMean differencce|4.0|STANDARD_ERROR_OF_MEAN|8.44||0.6388|TWO_SIDED|95.0|-12.66|20.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||20.59|-12.66|0.6388
71749036|NCT03192176|143005300|SUPERIORITY||LSMean difference|4.9|STANDARD_ERROR_OF_MEAN|8.79||0.5797|TWO_SIDED|95.0|-12.43|22.19||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||22.19|-12.43|0.5797
71749037|NCT03192176|143005300|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|8.78||0.4817|TWO_SIDED|95.0|-11.1|23.47||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.47|-11.10|0.4817
71749038|NCT03192176|143005300|SUPERIORITY||LSMean differencce|10.5|STANDARD_ERROR_OF_MEAN|8.8||0.2358|TWO_SIDED|95.0|-6.87|27.79||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||27.79|-6.87|0.2358
71749039|NCT03192176|143005300|SUPERIORITY||LSMean difference|14.3|STANDARD_ERROR_OF_MEAN|8.86||0.107|TWO_SIDED|95.0|-3.11|31.77||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||31.77|-3.11|0.1070
71749040|NCT03192176|143005300|SUPERIORITY||LSMean difference|6.7|STANDARD_ERROR_OF_MEAN|8.47||0.4268|TWO_SIDED|95.0|-9.94|23.43||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 14||23.43|-9.94|0.4268
71749041|NCT03192176|143005300|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|8.61||0.9197|TWO_SIDED|95.0|-17.81|16.08||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.08|-17.81|0.9197
71749042|NCT03192176|143005300|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|8.54||0.9954|TWO_SIDED|95.0|-16.77|16.87||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||16.87|-16.77|0.9954
71749043|NCT03192176|143005300|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|9.0||0.9607|TWO_SIDED|95.0|-17.28|18.17||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||18.17|-17.28|0.9607
71749044|NCT03192176|143005300|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|8.87||0.6625|TWO_SIDED|95.0|-21.33|13.59||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||13.59|-21.33|0.6625
71667911|NCT00866359|142852276|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.9|-2.4|<0.0001
71667912|NCT00866359|142852277|SUPERIORITY_OR_OTHER_LEGACY||Least Squares mean difference|-26.8|||<|0.0001|TWO_SIDED|95.0|-35.5|-18.0|||ANCOVA||Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.|||-18.0|-35.5|<0.0001
71667913|NCT00866359|142852280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-90.07|||<|0.0001|TWO_SIDED|95.0|-125.32|-54.82||The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.|ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-54.82|-125.32|<0.0001
71667914|NCT00866359|142852283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0007|TWO_SIDED|95.0|-2.7|-0.8|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.|||-0.8|-2.7|0.0007
71749045|NCT03192176|143005300|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|9.01||0.9952|TWO_SIDED|95.0|-17.81|17.7||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||17.70|-17.81|0.9952
71749046|NCT03192176|143005300|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|9.02||0.4001|TWO_SIDED|95.0|-10.16|25.36||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& BM as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||25.36|-10.16|0.4001
71749047|NCT03192176|143005300|SUPERIORITY||LSMean difference|-2.7|STANDARD_ERROR_OF_MEAN|8.54||0.751|TWO_SIDED|95.0|-19.52|14.1||LSM, SE, CI, \& p-values come from an MMRM model with PR from baseline as dependent variable \& TG, visit and smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& interaction of BM by week.|MMRM|||Week 15||14.10|-19.52|0.7510
71749048|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0018|TWO_SIDED|95.0|1.95|18.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.64|1.95|0.0018
71749049|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|8.28||||0.0002|TWO_SIDED|95.0|2.7|25.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.42|2.70|0.0002
71749050|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|10.92|||<|0.0001|TWO_SIDED|95.0|3.53|33.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.74|3.53|<0.0001
71781062|NCT02100514|143061637|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-40.5|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-44.8|-36.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-36.1|-44.8|
71781063|NCT02100514|143061637|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-32.7|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|95.0|-37.0|-28.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-28.4|-37.0|
71667915|NCT00866359|142852284|SUPERIORITY_OR_OTHER_LEGACY||adjusted difference (percentage)|39.1|||<|0.0001|TWO_SIDED|95.0|23.6|54.5|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test adjusting for gender.|Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.|||54.5|23.6|<0.0001
71749051|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|12.18|||<|0.0001|TWO_SIDED|95.0|3.91|37.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.89|3.91|<0.0001
71749052|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2244|TWO_SIDED|95.0|0.64|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.92|0.64|0.2244
71749053|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|8.58||||0.0002|TWO_SIDED|95.0|2.77|26.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.53|2.77|0.0002
71781064|NCT02100514|143061638|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-51.6|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-56.7|-46.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-46.6|-56.7|<0.001
71835282|NCT04732494|143175371|OTHER||LS Mean Difference|3.1|||||TWO_SIDED|95.0|-5.0|11.2||||||Analysis of Change from Baseline in Global Health Status/QoL at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-5.0|
71749054|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|8.25||||0.0002|TWO_SIDED|95.0|2.71|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.13|2.71|0.0002
71749055|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0149|TWO_SIDED|95.0|1.24|7.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.45|1.24|0.0149
71749056|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.65||||0.0011|TWO_SIDED|95.0|1.85|11.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.73|1.85|0.0011
71749057|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0001|TWO_SIDED|95.0|2.46|16.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.45|2.46|0.0001
71749058|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.87||||0.0001|TWO_SIDED|95.0|2.56|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.56|0.0001
71749059|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0897|TWO_SIDED|95.0|0.89|5.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.34|0.89|0.0897
71749060|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.46||||0.007|TWO_SIDED|95.0|1.42|8.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.53|1.42|0.0070
71749061|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0041|TWO_SIDED|95.0|1.52|9.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.23|1.52|0.0041
71677059|NCT00986921|142872577|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0||||A threshold value of p of 0.05 was considered significant.|Chi-squared|||The null hypothesis was that the groups would vary, with a p values of less than 0.05.||||0.49
71749062|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0254|TWO_SIDED|95.0|1.13|6.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.78|1.13|0.0254
71749063|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0032|TWO_SIDED|95.0|1.59|10.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.04|1.59|0.0032
71749064|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0002|TWO_SIDED|95.0|2.37|16.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.51|2.37|0.0002
71749065|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|8.78|||<|0.0001|TWO_SIDED|95.0|3.0|25.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.70|3.00|<0.0001
71749066|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0214|TWO_SIDED|95.0|1.17|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.18|1.17|0.0214
71749067|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0049|TWO_SIDED|95.0|1.48|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.09|1.48|0.0049
71749068|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0078|TWO_SIDED|95.0|1.38|8.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.22|1.38|0.0078
71835283|NCT04732494|143175371|SUPERIORITY||LS Mean Difference|-1.7|||||TWO_SIDED|95.0|-7.1|3.7||||||Analysis of Change from Baseline in Physical Functioning at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||3.7|-7.1|
71667916|NCT00866359|142852285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0007|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA||Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.|||-0.5|-1.7|0.0007
71667917|NCT01625091|142852300|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71667918|NCT01625091|142852301|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71667919|NCT01625091|142852302|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71891508|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.026||0.0007|TWO_SIDED|95.0|0.037|0.138||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.138|0.037|0.0007
71891509|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.043|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.144|0.043|0.0003
71891510|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.003|TWO_SIDED|95.0|0.026|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.127|0.026|0.0030
71667920|NCT01625091|142852303|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
71749069|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0727|TWO_SIDED|95.0|0.93|5.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.63|0.93|0.0727
71749070|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0199|TWO_SIDED|95.0|1.19|7.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.29|1.19|0.0199
71749071|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0034|TWO_SIDED|95.0|1.61|11.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.01|1.61|0.0034
71749072|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0007|TWO_SIDED|95.0|2.16|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.26|2.16|0.0007
71749073|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1206|TWO_SIDED|95.0|0.83|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.92|0.83|0.1206
71749074|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.58||||0.007|TWO_SIDED|95.0|1.42|9.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.03|1.42|0.0070
71891511|NCT01431287|143304565|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.026||0.5159|TWO_SIDED|95.0|-0.034|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.068|-0.034|0.5159
71667921|NCT03051672|142852318|SUPERIORITY|||||||||||||The study terminated at stage 1 and no p-value was estimated.||||The study uses a Simon 2-stage design. In stage 1, if \>/=1 of 8 achieved OR then continue to stage 2 (enroll 19 more). If \>/= 3 of 27 respond, the regimen would be considered promising. The null ORR\<= 3% and alternative ORR\>/=20%. With this design, the probability of stopping the trial early is 58% if the true ORR is 3%. This design at 80% power to declare the combination effective, while controlling for less than 5% 1-sided type I error under the null hypothesis.|The study terminated at stage 1 and no p-value was estimated.|||
71667922|NCT01459783|142852325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.76|TWO_SIDED|95.0|-5.13|6.95||We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||6.95|-5.13|0.76
71677060|NCT00986921|142872578|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71677061|NCT02778074|142872593|SUPERIORITY||Mean Difference (Final Values)|-2.34|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71749075|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.41||||0.0088|TWO_SIDED|95.0|1.36|8.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.54|1.36|0.0088
71749076|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4485|TWO_SIDED|95.0|0.58|3.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.40|0.58|0.4485
71667923|NCT01459783|142852326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.49|TWO_SIDED|95.0|-1.74|3.55||We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, \& intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.||3.55|-1.74|0.49
71667924|NCT04211831|142852331|OTHER||Least square mean difference|-1.29|||=|0.1722|TWO_SIDED|95.0|-3.16|0.58|||mixed model for repeated measures||Treatment comparison between Placebo and URO-902 24 mg using least sqaure mean difference and 95% confidence interval (CI) has been presented.|||0.58|-3.16|=0.1722
71667925|NCT04211831|142852331|OTHER||Least Square Mean Difference|-2.24|||=|0.0159|TWO_SIDED|95.0|-4.04|-0.43|||Mixed model for repeated measures||Treatment comparison between Placebo and URO-902 48 mg using least sqaure mean difference and 95% CI has been presented.|||-0.43|-4.04|=0.0159
71667926|NCT01256879|142852333|OTHER|Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC.|||||||||||||||||Bioequivalence testing of AUC, per FDA guidance, is applied. Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC. The upper and lower 90% Confidence Interval for CimTest-A is 104.4% to 120.6%. The upper and lower 90% Confidence Interval for CimTest-B is 97.9% to 113.0%. The upper and lower 90% Confidence Interval for Commercial Cimetidine Solution is 93.2% to 107.7%.|||
71667927|NCT04927845|142852404|SUPERIORITY||between-group effect size Cohen's d|0.24||||0.008|TWO_SIDED|95.0|0.06|0.41|||linear mixed effects, groupXtime term|||||0.41|0.06|.008
71667928|NCT04927845|142852404|SUPERIORITY||Slope|1.75||||0.03|TWO_SIDED||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: comparing the waitlist condition versus only intervention group participants who were program initiators||||.03
71667929|NCT04927845|142852404|SUPERIORITY|||||||0.009|||||||linear mixed effects, groupXtime term|||Per Protocol Analyses of Intervention Effects: concurrent service use was added as a covariate to models.||||.009
71667930|NCT04927845|142852405|SUPERIORITY||between-group effect size Cohen's d|0.11||||0.21|TWO_SIDED||||||linear mixed effects, groupXtime term|||||||.21
71891512|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.159|0.261||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.261|0.159|<0.0001
71667931|NCT04927845|142852406|SUPERIORITY||between-group effect size Cohen's d|0.19||||0.046|TWO_SIDED|95.0|0.02|0.36|||linear mixed effects, groupXtime term|||||0.36|0.02|.046
71749077|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.92||||0.0255|TWO_SIDED|95.0|1.14|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.47|1.14|0.0255
71749078|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0066|TWO_SIDED|95.0|1.49|11.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.75|1.49|0.0066
71667932|NCT05351164|142852418|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71667933|NCT05351164|142852419|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71667934|NCT03493685|142852420|OTHER||Slope difference|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.7491|TWO_SIDED|95.0|-1.74|2.41|||Mixed Models Analysis|||||2.41|-1.74|0.7491
71667935|NCT03493685|142852421|OTHER||Risk Difference (RD)|16.0||||0.0094|TWO_SIDED|95.0|3.96|28.04|||Mixed Models Analysis|||||28.04|3.96|0.0094
71667936|NCT03493685|142852422|OTHER||Slope difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4203|TWO_SIDED|95.0|-1.27|3.04|||Mixed Models Analysis|||||3.04|-1.27|0.4203
71667937|NCT03493685|142852423|OTHER||Mean Difference (Final Values)|1.8||||0.2708|TWO_SIDED|95.0|-1.39|4.93|||ANCOVA|||||4.93|-1.39|0.2708
71667938|NCT03300817|142852429|SUPERIORITY|||||||0.6834|||||||Wilcoxon Rank-Sum test|||||||0.6834
71667939|NCT04467840|142852471|SUPERIORITY||Risk Difference (RD)|3.86||||0.391|TWO_SIDED|95.0|-4.93|12.65||The threshold for statistical significance was p = 0.05|Cochran-Mantel-Haenszel||Opaganib - Placebo|||12.65|-4.93|0.391
71667940|NCT04467840|142852472|SUPERIORITY||Risk Difference (RD)|3.91||||0.38|TWO_SIDED|95.0|-4.78|12.6||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||12.60|-4.78|0.380
71667941|NCT04467840|142852473|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.231|TWO_SIDED|95.0|0.91|1.45||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.45|0.91|0.231
71667942|NCT04467840|142852474|SUPERIORITY||Hazard Ratio, log|1.08||||0.472|TWO_SIDED|95.0|0.87|1.33||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.33|0.87|0.472
71667943|NCT04467840|142852475|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.521|TWO_SIDED|95.0|0.846|1.378||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Log Rank|||||1.378|0.846|0.521
71667944|NCT04467840|142852476|SUPERIORITY||Risk Difference (RD)|-1.51||||0.701|TWO_SIDED|95.0|-9.19|6.18||The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Cochran-Mantel-Haenszel|||||6.18|-9.19|0.701
71667945|NCT04467840|142852477|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Hazard Ratio (HR)|1.34||||0.043|TWO_SIDED|95.0|0.99|1.82|||Log Rank|||||1.82|0.99|0.043
71667946|NCT04467840|142852478|SUPERIORITY|The threshold for statistical significance was p = 0.05, only if the primary endpoint was significant. This p-value is not adjusted for multiple comparisons because the primary endpoint was not met.|Risk Difference (RD)|8.3||||0.118|TWO_SIDED|95.0|-2.05|18.65|||Cochran-Mantel-Haenszel|||||18.65|-2.05|0.118
71667947|NCT04467840|142852482|SUPERIORITY||Risk Difference (RD)|12.28||||0.033|TWO_SIDED|95.0|1.06|23.5||unadjusted p-value|Cochran-Mantel-Haenszel|||||23.50|1.06|0.033
71667948|NCT04467840|142852483|SUPERIORITY||Risk Difference (RD)|-4.75||||0.5|TWO_SIDED|95.0|-18.67|9.17|||Cochran-Mantel-Haenszel|||||9.17|-18.67|0.500
71667949|NCT04467840|142852484|SUPERIORITY||Risk Difference (RD)|12.75||||0.023|TWO_SIDED|95.0|1.9|23.6|||Cochran-Mantel-Haenszel|||||23.60|1.90|0.023
71667950|NCT04467840|142852485|SUPERIORITY||Risk Difference (RD)|-4.12||||0.561|TWO_SIDED|95.0|-18.07|9.82|||Cochran-Mantel-Haenszel|||||9.82|-18.07|0.561
71667951|NCT04467840|142852486|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.01|TWO_SIDED|95.0|1.07|1.93|||Log Rank|||||1.93|1.07|0.01
71667952|NCT04467840|142852487|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.545|TWO_SIDED|95.0|0.58|1.34|||Log Rank|||||1.34|0.58|0.545
71667953|NCT04467840|142852488|SUPERIORITY||Hazard Ratio (HR)|1.276||||0.1|TWO_SIDED|95.0|0.94|1.732|||Log Rank|||||1.732|0.940|0.100
71667954|NCT04467840|142852490|SUPERIORITY||Risk Difference (RD)|-10.5||||0.012|TWO_SIDED|95.0|-18.44|-2.57|||Cochran-Mantel-Haenszel|||||-2.57|-18.44|0.012
71667955|NCT04467840|142852491|SUPERIORITY||Risk Difference (RD)|7.2||||0.304|TWO_SIDED|95.0|-6.46|20.86|||Cochran-Mantel-Haenszel|||||20.86|-6.46|0.304
71667956|NCT04467840|142852492|SUPERIORITY||Risk Difference (RD)|-9.22||||0.019|TWO_SIDED|95.0|-16.63|-1.8|||Cochran-Mantel-Haenszel|||||-1.80|-16.63|0.019
71667957|NCT04467840|142852493|SUPERIORITY||Risk Difference (RD)|7.37||||0.273|TWO_SIDED|95.0|-5.66|20.39|||Cochran-Mantel-Haenszel|||||20.39|-5.66|0.273
71667958|NCT05201794|142852496|SUPERIORITY||Odds Ratio (OR)|67.3|||=|0.1409|ONE_SIDED|80.0|15.2|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for proof-of-concept (PoC) when the planned interim analysis would have been performed.|||15.2|=0.1409
71667959|NCT05201794|142852496|SUPERIORITY||Odds Ratio (OR)|67.2|||=|0.1418|ONE_SIDED|80.0|14.9|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||14.9|=0.1418
71667960|NCT05201794|142852497|SUPERIORITY||Odds Ratio (OR)|87.8|||=|0.0192|ONE_SIDED|80.0|58.1|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||58.1|=0.0192
71667961|NCT05201794|142852497|SUPERIORITY||Odds Ratio (OR)|62.9|||=|0.1131|ONE_SIDED|80.0|20.0|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||20|=0.1131
71677062|NCT01817582|142872594|OTHER||Least square (LS) mean difference|0.3||||0.6199|TWO_SIDED|95.0|-0.7|1.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.3|-0.7|0.6199
71677063|NCT01817582|142872594|OTHER||LS mean difference|0.1||||0.807|TWO_SIDED|95.0|-0.9|1.2||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||1.2|-0.9|0.8070
71749079|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0061|TWO_SIDED|95.0|1.53|13.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.01|1.53|0.0061
71749080|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0879|TWO_SIDED|95.0|0.89|5.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.57|0.89|0.0879
71749081|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0389|TWO_SIDED|95.0|1.05|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.83|1.05|0.0389
71749082|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0446|TWO_SIDED|95.0|1.02|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.73|1.02|0.0446
71749083|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8196|TWO_SIDED|95.0|0.45|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.72|0.45|0.8196
71749084|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.0||||0.145|TWO_SIDED|95.0|0.79|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.10|0.79|0.1450
71781065|NCT02100514|143061638|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.4|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-52.2|-40.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-40.6|-52.2|
71667962|NCT05201794|142852498|SUPERIORITY||Odds Ratio (OR)|85.4|||=|0.0302|ONE_SIDED|80.0|62.6|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||62.6|=0.0302
71667963|NCT05201794|142852498|SUPERIORITY||Odds Ratio (OR)|60.5|||=|0.2239|ONE_SIDED|80.0|-6.3|||One-sided p-value|Exact logistic regression model|P-value was obtained from an exact logistic regression model adjusted for stratification factor region (America, Asia).|1-sided odds-ratio and 80% CI were obtained from exact logistic regression model adjusted for region (America, Asia).|The study was prematurely terminated before reaching the number of laboratory-confirmed DENV infections that were planned for the interim analysis. The 1-sided 20% significance level was described in the protocol as the significance level for PoC when the planned interim analysis would have been performed.|||-6.3|=0.2239
71667964|NCT06418529|142852505|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
71667965|NCT06418529|142852506|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.07||||||||1.07|0.83|
71749085|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.08||||0.0114|TWO_SIDED|95.0|1.37|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.11|1.37|0.0114
71749086|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0307|TWO_SIDED|95.0|1.12|9.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.71|1.12|0.0307
71749087|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5921|TWO_SIDED|95.0|0.51|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.24|0.51|0.5921
71749088|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0502|TWO_SIDED|95.0|1.0|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.26|1.00|0.0502
71749089|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0224|TWO_SIDED|95.0|1.18|9.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.25|1.18|0.0224
71749090|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7225|TWO_SIDED|95.0|0.47|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||2.93|0.47|0.7225
71667966|NCT06418529|142852507|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.79|0.99||||||||0.99|0.79|
71667967|NCT06418529|142852508|OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.79|1.04||||||||1.04|0.79|
71749091|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0762|TWO_SIDED|95.0|0.91|6.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.48|0.91|0.0762
71749092|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0252|TWO_SIDED|95.0|1.17|10.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.53|1.17|0.0252
71667968|NCT06418529|142852509|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.81|1.05||||||||1.05|0.81|
71749093|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.98||||0.049|TWO_SIDED|95.0|1.0|8.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.87|1.00|0.0490
71749094|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1773|TWO_SIDED|95.0|0.74|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.30|0.74|0.1773
71749095|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0609|TWO_SIDED|95.0|0.96|7.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.16|0.96|0.0609
71749096|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1364|TWO_SIDED|95.0|0.79|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.61|0.79|0.1364
71667969|NCT06418529|142852510|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09||||||||1.09|0.79|
71781066|NCT02100514|143061638|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-37.4|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|95.0|-43.3|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.4|-43.3|
71667970|NCT04653454|142852512|SUPERIORITY|||||||0.129||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.129
71667971|NCT04653454|142852512|SUPERIORITY|||||||0.008||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.008
71667972|NCT04653454|142852513|SUPERIORITY|||||||0.203||||||Hypoglycemic Episodes \<54 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.203
71749097|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5268|TWO_SIDED|95.0|0.53|3.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.51|0.53|0.5268
71749098|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1645|TWO_SIDED|95.0|0.75|5.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.46|0.75|0.1645
71749099|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0215|TWO_SIDED|95.0|1.22|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||12.57|1.22|0.0215
71749100|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.04||||0.06|TWO_SIDED|95.0|0.95|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|0.95|0.0600
71749101|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6503|TWO_SIDED|95.0|0.47|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.32|0.47|0.6503
71749102|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0683|TWO_SIDED|95.0|0.93|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.93|0.0683
71667973|NCT04653454|142852513|SUPERIORITY||||||<|0.001||||||Hypoglycemic Episodes \<70 mg/dL|Wilcoxon (Mann-Whitney)|||||||<0.001
71667974|NCT04653454|142852515|SUPERIORITY|||||||0.076||||||Hyperglycemic Episodes \>180 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.076
71667975|NCT04653454|142852515|SUPERIORITY|||||||0.038||||||Hyperglycemic Episodes \>250 mg/dL|Wilcoxon (Mann-Whitney)|||||||0.038
71667976|NCT04653454|142852516|SUPERIORITY||||||<|0.0001||||||Creatinine|Spearman Correlation coefficients|||||||<0.0001
71667977|NCT04653454|142852516|SUPERIORITY|||||||0.0002||||||139GFR|Spearman Correlation coefficients|||||||0.0002
71667978|NCT04653454|142852516|SUPERIORITY|||||||0.22||||||Bicarbonate|Spearman Correlation coefficients|||||||0.22
71667979|NCT04653454|142852516|SUPERIORITY|||||||0.48||||||Hemoglobin|Spearman Correlation coefficients|||||||0.48
71667980|NCT04653454|142852516|SUPERIORITY|||||||0.77||||||MAP|Spearman Correlation coefficients|||||||0.77
71667981|NCT04653454|142852516|SUPERIORITY|||||||0.0516||||||SpO2|Spearman Correlation coefficients|||||||0.0516
71667982|NCT03620708|142852521|SUPERIORITY||chi-square|3.492|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71667983|NCT03620708|142852522|SUPERIORITY||chi-square|4.36||||0.113|TWO_SIDED||||||Chi-squared|||||||.113
71667984|NCT03620708|142852523|SUPERIORITY||Mean Difference (Final Values)|3.661||||0.032|TWO_SIDED||||||ANOVA|||||||.032
71667985|NCT03620708|142852524|SUPERIORITY||Mean Difference (Final Values)|1.543||||0.227|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of confidence in ability to quit.||||.227
71667986|NCT03620708|142852524|SUPERIORITY||Mean Difference (Final Values)|0.338||||0.715|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.||||.715
71667987|NCT03620708|142852524|SUPERIORITY||Mean Difference (Final Values)|1.712||||0.19|TWO_SIDED||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.||||.190
71667988|NCT03620708|142852525|SUPERIORITY||Mean Difference (Final Values)|1.728||||0.188|TWO_SIDED||||||ANOVA|||||||.188
71667989|NCT05525520|142852567|EQUIVALENCE|two-sided equivalence test|Least square mean difference (LSMD)|0.46|STANDARD_ERROR_OF_MEAN|0.609||0.4577|TWO_SIDED|95.0|-0.77|1.68|||MMRM|Treatment, type of cholestatic disease, week, and treatment-by-week interaction were fixed effects, and Baseline WI-NRS score was a covariate.|LSMD=EP547 minus placebo|||1.68|-0.77|0.4577
71667990|NCT03176134|142852588|OTHER||Estimated Difference|6.5|||||TWO_SIDED|95.0|-12.2|25.3|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||25.3|-12.2|
71667991|NCT03176134|142852588|OTHER||Estimated Difference|-12.5|||||TWO_SIDED|95.0|-28.7|3.7|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||3.7|-28.7|
71667992|NCT03176134|142852588|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71667993|NCT03176134|142852588|OTHER||Estimated Difference|1.3|||||TWO_SIDED|95.0|-10.7|13.4|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||13.4|-10.7|
71667994|NCT03176134|142852589|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71667995|NCT03176134|142852589|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71667996|NCT03176134|142852589|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71667997|NCT03176134|142852589|OTHER||Estimated Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71667998|NCT01783990|142852655|SUPERIORITY|||||||0.33|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.33
71667999|NCT01783990|142852656|SUPERIORITY|||||||0.8|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.80
71668000|NCT01783990|142852657|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.87
71781067|NCT02100514|143061639|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-46.6|STANDARD_ERROR_OF_MEAN|3.59|<|0.001||95.0|-53.7|-39.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-53.7|<0.001
71668001|NCT01783990|142852658|SUPERIORITY|||||||0.28|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.28
71668002|NCT01783990|142852659|SUPERIORITY|||||||0.31|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.31
71668003|NCT01783990|142852660|SUPERIORITY|||||||0.04|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.04
71668004|NCT03718832|142852661|SUPERIORITY||Mean Difference (Net)|-0.0333487|STANDARD_ERROR_OF_MEAN|0.1943638||0.8638688|TWO_SIDED|95.0|-0.415628|0.3489306||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.3489306|-0.415628|0.8638688
71668005|NCT03718832|142852661|SUPERIORITY||Mean Difference (Net)|-0.0066385|STANDARD_ERROR_OF_MEAN|0.1853917||0.9714571|TWO_SIDED|95.0|-0.371329|0.358052||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.358052|-0.371329|0.9714571
71668006|NCT03718832|142852662|SUPERIORITY||Mean Difference (Net)|0.1409446|STANDARD_ERROR_OF_MEAN|0.2106711||0.5039565|TWO_SIDED|95.0|-0.2735162|0.5554053||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.5554053|-0.2735162|0.5039565
71668007|NCT03718832|142852662|SUPERIORITY||Mean Difference (Net)|0.1213915|STANDARD_ERROR_OF_MEAN|0.2126328||0.5684854|TWO_SIDED|95.0|-0.2970052|0.5397882||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.5397882|-0.2970052|0.5684854
71668008|NCT03718832|142852663|SUPERIORITY||Mean Difference (Net)|-13.26835|STANDARD_ERROR_OF_MEAN|10.90353||0.2247426|TWO_SIDED|95.0|-34.73804|8.201347||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||8.201347|-34.73804|0.2247426
71668009|NCT03718832|142852663|SUPERIORITY||Mean Difference (Net)|-12.20164|STANDARD_ERROR_OF_MEAN|11.25555||0.2794015|TWO_SIDED|95.0|-34.37119|9.9679||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||9.9679|-34.37119|0.2794015
71668010|NCT03718832|142852663|SUPERIORITY||Mean Difference (Net)|13.12548|STANDARD_ERROR_OF_MEAN|9.550462||0.1708328|TWO_SIDED|95.0|-5.703702|31.95466||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||31.95466|-5.703702|0.1708328
71749103|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0618|TWO_SIDED|95.0|0.95|8.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.44|0.95|0.0618
71749104|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5621|TWO_SIDED|95.0|0.5|3.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.63|0.50|0.5621
71749105|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.92||||0.2182|TWO_SIDED|95.0|0.68|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.40|0.68|0.2182
71749106|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.11||||0.06|TWO_SIDED|95.0|0.95|10.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.15|0.95|0.0600
71749107|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.6||||0.029|TWO_SIDED|95.0|1.17|18.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.12|1.17|0.0290
71749108|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8485|TWO_SIDED|95.0|0.4|3.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.04|0.40|0.8485
71749109|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1652|TWO_SIDED|95.0|0.73|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.42|0.73|0.1652
71668011|NCT03718832|142852663|SUPERIORITY||Mean Difference (Net)|11.47577|STANDARD_ERROR_OF_MEAN|10.59479||0.2801138|TWO_SIDED|95.0|-9.422762|32.3743||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||32.3743|-9.422762|0.2801138
71668012|NCT03718832|142852664|SUPERIORITY||Mean Difference (Net)|-8.135585|STANDARD_ERROR_OF_MEAN|6.325031||0.1991028|TWO_SIDED|95.0|-20.57023|4.299061||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||4.299061|-20.57023|0.1991028
71668013|NCT03718832|142852664|SUPERIORITY||Mean Difference (Net)|3.493798|STANDARD_ERROR_OF_MEAN|1.761916||0.0480884|TWO_SIDED|95.0|0.0295297|6.958066||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||6.958066|0.0295297|0.0480884
71749110|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2244|TWO_SIDED|95.0|0.67|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.65|0.67|0.2244
71749111|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2097|TWO_SIDED|95.0|0.71|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.84|0.71|0.2097
71749112|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.53||||0.3708|TWO_SIDED|95.0|0.6|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.92|0.60|0.3708
71781068|NCT02100514|143061639|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-39.7|STANDARD_ERROR_OF_MEAN|4.12||||95.0|-47.9|-31.6||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-31.6|-47.9|
71677064|NCT01817582|142872594|OTHER||LS mean difference|-0.1||||0.8068|TWO_SIDED|95.0|-1.1|0.9||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||0.9|-1.1|0.8068
71749113|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0704|TWO_SIDED|95.0|0.92|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.66|0.92|0.0704
71749114|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|7.21||||0.004|TWO_SIDED|95.0|1.88|27.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.73|1.88|0.0040
71749115|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1625|TWO_SIDED|95.0|0.75|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.55|0.75|0.1625
71749116|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0093|TWO_SIDED|95.0|1.46|14.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.50|1.46|0.0093
71781069|NCT02100514|143061639|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-33.4|STANDARD_ERROR_OF_MEAN|4.02||||95.0|-41.3|-25.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-25.5|-41.3|
71781070|NCT02100514|143061640|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-30.8|STANDARD_ERROR_OF_MEAN|3.14|<|0.001||95.0|-36.9|-24.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-24.6|-36.9|<0.001
71668014|NCT03718832|142852664|SUPERIORITY||Mean Difference (Net)|-9.681804|STANDARD_ERROR_OF_MEAN|6.34136||0.1276817|TWO_SIDED|95.0|-22.15188|2.788269||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.788269|-22.15188|0.1276817
71781071|NCT02100514|143061640|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-27.5|STANDARD_ERROR_OF_MEAN|3.23||||95.0|-33.9|-21.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.2|-33.9|
71781072|NCT02100514|143061640|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-49.4|STANDARD_ERROR_OF_MEAN|18.27|||TWO_SIDED|95.0|-85.2|-13.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.5|-85.2|
71781073|NCT02100514|143061641|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.5|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|3.4|7.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.4|<0.001
71835284|NCT04732494|143175371|OTHER||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-10.3|9.3||||||Analysis of Change from Baseline in Physical Functioning at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.3|-10.3|
71668015|NCT03718832|142852664|SUPERIORITY||Mean Difference (Net)|1.658257|STANDARD_ERROR_OF_MEAN|1.706497||0.3318554|TWO_SIDED|95.0|-1.698022|5.014535||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||5.014535|-1.698022|0.3318554
71668016|NCT03718832|142852665|SUPERIORITY||Mean Difference (Net)|-0.8749266|STANDARD_ERROR_OF_MEAN|0.9355095||0.3502313|TWO_SIDED|95.0|-2.714084|0.9642311||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.9642311|-2.714084|0.3502313
71781074|NCT02100514|143061641|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|5.4|STANDARD_ERROR_OF_MEAN|1.14||||95.0|3.2|7.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.6|3.2|
71781075|NCT02100514|143061641|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|6.0|STANDARD_ERROR_OF_MEAN|1.2||||95.0|3.6|8.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||8.3|3.6|
71781076|NCT02100514|143061642|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-44.2|STANDARD_ERROR_OF_MEAN|2.39||||95.0|-48.8|-39.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-39.5|-48.8|
71749117|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|4.44||||0.0103|TWO_SIDED|95.0|1.42|13.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.87|1.42|0.0103
71781077|NCT02100514|143061642|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-36.2|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-40.9|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-31.4|-40.9|
71781078|NCT02100514|143061643|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
71749118|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.89||||0.1965|TWO_SIDED|95.0|0.72|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.72|0.1965
71749119|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0549|TWO_SIDED|95.0|0.98|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.42|0.98|0.0549
71749120|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0503|TWO_SIDED|95.0|1.0|9.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.09|1.00|0.0503
71749121|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|7.03||||0.0046|TWO_SIDED|95.0|1.82|27.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||27.10|1.82|0.0046
71749122|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0866|TWO_SIDED|95.0|0.88|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.88|0.88|0.0866
71749123|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|5.96||||0.0045|TWO_SIDED|95.0|1.74|20.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.40|1.74|0.0045
71749124|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0207|TWO_SIDED|95.0|1.22|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.62|1.22|0.0207
71749125|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2127|TWO_SIDED|95.0|0.7|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.91|0.70|0.2127
71891513|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.026||0.0006|TWO_SIDED|95.0|0.038|0.141||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.141|0.038|0.0006
71677065|NCT01817582|142872595|OTHER||LS mean difference|-4.4||||0.2296|TWO_SIDED|95.0|-11.6|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.8|-11.6|0.2296
71749126|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.04||||0.1521|TWO_SIDED|95.0|0.77|5.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.43|0.77|0.1521
71749127|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0098|TWO_SIDED|95.0|1.48|17.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.70|1.48|0.0098
71749128|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0047|TWO_SIDED|95.0|1.82|27.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||27.50|1.82|0.0047
71749129|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1817|TWO_SIDED|95.0|0.72|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.51|0.72|0.1817
71749130|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0042|TWO_SIDED|95.0|1.77|20.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.95|1.77|0.0042
71749131|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0039|TWO_SIDED|95.0|1.78|20.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.74|1.78|0.0039
71749132|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.23||||0.7025|TWO_SIDED|95.0|0.42|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.42|0.7025
71749133|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9599|TWO_SIDED|95.0|0.36|2.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.97|0.36|0.9599
71749134|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9671|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.10|0.34|0.9671
71781079|NCT02100514|143061643|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
71781080|NCT02100514|143061643|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
71781081|NCT02100514|143061644|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.1|STANDARD_ERROR_OF_MEAN|0.85||||95.0|2.5|5.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.8|2.5|
71781082|NCT02100514|143061644|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|3.8|STANDARD_ERROR_OF_MEAN|0.86||||95.0|2.2|5.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||5.5|2.2|
71781083|NCT02100514|143061644|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|4.3|STANDARD_ERROR_OF_MEAN|0.97||||95.0|2.4|6.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.2|2.4|
71781084|NCT02100514|143061645|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|1.1|STANDARD_ERROR_OF_MEAN|0.9||||95.0|-0.7|2.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.8|-0.7|
71781085|NCT02100514|143061645|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.9|STANDARD_ERROR_OF_MEAN|1.04||||95.0|-1.1|3.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.0|-1.1|
71781086|NCT02100514|143061645|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|0.8|STANDARD_ERROR_OF_MEAN|0.95||||95.0|-1.0|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|-1.0|
71781087|NCT02100514|143061646|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.1|STANDARD_ERROR_OF_MEAN|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-5.1|-15.1|
71781088|NCT02100514|143061646|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-9.0|STANDARD_ERROR_OF_MEAN|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-17.9|
71677066|NCT01817582|142872595|OTHER||LS mean difference|-4.9||||0.189|TWO_SIDED|95.0|-12.3|2.5||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||2.5|-12.3|0.1890
71781089|NCT02100514|143061646|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-8.2|STANDARD_ERROR_OF_MEAN|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-2.2|-14.1|
71781090|NCT02100514|143061647|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.8|STANDARD_ERROR_OF_MEAN|3.18||||95.0|-73.0|-60.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-60.5|-73.0|
71781091|NCT02100514|143061648|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.1|STANDARD_ERROR_OF_MEAN|5.4||||95.0|-76.7|-55.4||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.4|-76.7|
71749135|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.26||||0.681|TWO_SIDED|95.0|0.42|3.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.83|0.42|0.6810
71781092|NCT02100514|143061649|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-66.5|STANDARD_ERROR_OF_MEAN|2.77||||95.0|-72.0|-61.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-61.1|-72.0|
71835285|NCT04732494|143175372|OTHER||LS Mean Difference|-9.9|||||TWO_SIDED|95.0|-21.5|1.6||||||Analysis of Change from Baseline in Dysphagia at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.6|-21.5|
71749136|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6346|TWO_SIDED|95.0|0.43|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.04|0.43|0.6346
71749137|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7929|TWO_SIDED|95.0|0.38|3.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.57|0.38|0.7929
71749138|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8188|TWO_SIDED|95.0|0.39|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.28|0.39|0.8188
71749139|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8226|TWO_SIDED|95.0|0.3|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.60|0.30|0.8226
71749140|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9088|TWO_SIDED|95.0|0.32|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.72|0.32|0.9088
71749141|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6189|TWO_SIDED|95.0|0.24|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.24|0.6189
71749142|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6463|TWO_SIDED|95.0|0.42|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.03|0.42|0.6463
71749143|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.47||||0.506|TWO_SIDED|95.0|0.47|4.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.54|0.47|0.5060
71891514|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.183|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.234|0.132|<0.0001
71677067|NCT01817582|142872595|OTHER||LS mean difference|-0.5||||0.8836|TWO_SIDED|95.0|-7.7|6.7||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.||6.7|-7.7|0.8836
71749144|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3842|TWO_SIDED|95.0|0.53|5.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.31|0.53|0.3842
71749145|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5021|TWO_SIDED|95.0|0.49|4.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.23|0.49|0.5021
71749146|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.42||||0.1349|TWO_SIDED|95.0|0.14|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.31|0.14|0.1349
71749147|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3191|TWO_SIDED|95.0|0.19|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.19|0.3191
71749148|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.3||||0.0623|TWO_SIDED|95.0|0.09|1.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.06|0.09|0.0623
71749149|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1958|TWO_SIDED|95.0|0.15|1.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.48|0.15|0.1958
71749150|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4353|TWO_SIDED|95.0|0.19|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.19|0.4353
71668017|NCT03718832|142852665|SUPERIORITY||Mean Difference (Net)|0.5608222|STANDARD_ERROR_OF_MEAN|0.2708671||0.0390797|TWO_SIDED|95.0|0.0282451|1.093399||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.093399|0.0282451|0.0390797
71668018|NCT03718832|142852665|SUPERIORITY||Mean Difference (Net)|-1.450197|STANDARD_ERROR_OF_MEAN|0.9508997||0.1281032|TWO_SIDED|95.0|-3.320109|0.419716||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.419716|-3.320109|0.1281032
71668019|NCT03718832|142852665|SUPERIORITY||Mean Difference (Net)|0.2794625|STANDARD_ERROR_OF_MEAN|0.2717457||0.3044732|TWO_SIDED|95.0|-0.2549974|0.8139224||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.8139224|-0.2549974|0.3044732
71668020|NCT03718832|142852666|SUPERIORITY||Mean Difference (Net)|9.768353|STANDARD_ERROR_OF_MEAN|5.933945||0.1007463|TWO_SIDED|95.0|-1.907847|21.44455||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||21.44455|-1.907847|0.1007463
71668021|NCT03718832|142852666|SUPERIORITY||Mean Difference (Net)|4.472004|STANDARD_ERROR_OF_MEAN|5.150772||0.3859868|TWO_SIDED|95.0|-5.66534|14.60935||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||14.60935|-5.66534|0.3859868
71668022|NCT03718832|142852666|SUPERIORITY||Mean Difference (Net)|-0.5461143|STANDARD_ERROR_OF_MEAN|6.440905||0.9324908|TWO_SIDED|95.0|-13.22545|12.13323||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Unadjusted mean difference, 12 months after trial enrollment||12.13323|-13.22545|0.9324908
71668023|NCT03718832|142852666|SUPERIORITY||Mean Difference (Net)|-2.752831|STANDARD_ERROR_OF_MEAN|5.754947||0.6328075|TWO_SIDED|95.0|-14.08487|8.579205||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||8.579205|-14.08487|0.6328075
71749151|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9729|TWO_SIDED|95.0|0.31|3.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.31|0.31|0.9729
71781093|NCT02100514|143061650|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-69.1|STANDARD_ERROR_OF_MEAN|3.08||||95.0|-75.2|-63.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.1|-75.2|
71668024|NCT03718832|142852667|SUPERIORITY||Mean Difference (Net)|8.352141|STANDARD_ERROR_OF_MEAN|4.663846||0.0743062|TWO_SIDED|95.0|-0.8250086|17.52929||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||17.52929|-0.8250086|0.0743062
71668025|NCT03718832|142852667|SUPERIORITY||Mean Difference (Net)|5.971188|STANDARD_ERROR_OF_MEAN|3.902349||0.1270654|TWO_SIDED|95.0|-1.709219|13.65159||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||13.65159|-1.709219|0.1270654
71668026|NCT03718832|142852667|SUPERIORITY||Mean Difference (Net)|2.637485|STANDARD_ERROR_OF_MEAN|4.443227||0.553277|TWO_SIDED|95.0|-6.110146|11.38512||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||11.38512|-6.110146|0.553277
71668027|NCT03718832|142852667|SUPERIORITY||Mean Difference (Net)|2.53149|STANDARD_ERROR_OF_MEAN|3.925307||0.519562|TWO_SIDED|95.0|-5.198658|10.26164||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||10.26164|-5.198658|0.519562
71668028|NCT03718832|142852668|SUPERIORITY||Mean Difference (Net)|-0.555117|STANDARD_ERROR_OF_MEAN|1.427417||0.6976216|TWO_SIDED|95.0|-3.363839|2.253605||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.253605|-3.363839|0.6976216
71668029|NCT03718832|142852668|SUPERIORITY||Mean Difference (Net)|-0.4977997|STANDARD_ERROR_OF_MEAN|1.041102||0.6329035|TWO_SIDED|95.0|-2.546815|1.551216||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.551216|-2.546815|0.6329035
71668030|NCT03718832|142852668|SUPERIORITY||Mean Difference (Net)|-1.386111|STANDARD_ERROR_OF_MEAN|1.812939||0.445181|TWO_SIDED|95.0|-4.954999|2.182777||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.182777|-4.954999|0.445181
71668031|NCT03718832|142852668|SUPERIORITY||Mean Difference (Net)|-1.101914|STANDARD_ERROR_OF_MEAN|1.860687||0.5542241|TWO_SIDED|95.0|-4.765783|2.561956||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||2.561956|-4.765783|0.5542241
71668032|NCT03718832|142852669|SUPERIORITY||Mean Difference (Net)|22.55812|STANDARD_ERROR_OF_MEAN|17.74244||0.2045348|TWO_SIDED|95.0|-12.35316|57.4694||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||57.4694|-12.35316|0.2045348
71749152|NCT03192176|143005301|SUPERIORITY||Odds Ratio (OR)|0.64||||0.4211|TWO_SIDED|95.0|0.22|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.89|0.22|0.4211
71668033|NCT03718832|142852669|SUPERIORITY||Mean Difference (Net)|13.49781|STANDARD_ERROR_OF_MEAN|14.95579||0.3675252|TWO_SIDED|95.0|-15.93658|42.9322||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||42.9322|-15.93658|0.3675252
71668034|NCT03718832|142852669|SUPERIORITY||Mean Difference (Net)|-11.35256|STANDARD_ERROR_OF_MEAN|26.69115||0.6709307|TWO_SIDED|95.0|-63.8992|41.19407||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||41.19407|-63.8992|0.6709307
71749153|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.05||||0.1938|TWO_SIDED|95.0|0.57|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.35|0.57|0.1938
71749154|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|6.97||||0.0162|TWO_SIDED|95.0|1.43|33.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.91|1.43|0.0162
71749155|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|14.37||||0.0008|TWO_SIDED|95.0|3.04|67.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||67.96|3.04|0.0008
71781094|NCT02100514|143061651|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-71.3|STANDARD_ERROR_OF_MEAN|3.14||||95.0|-77.5|-65.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-65.1|-77.5|
71781095|NCT02100514|143061652|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-47.7|STANDARD_ERROR_OF_MEAN|2.12||||95.0|-51.9|-43.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.6|-51.9|
71891515|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.026||0.0094|TWO_SIDED|95.0|0.017|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.119|0.017|0.0094
71891516|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.026||0.0174|TWO_SIDED|95.0|0.011|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.011|0.0174
71891517|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.026||0.2888|TWO_SIDED|95.0|-0.023|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.079|-0.023|0.2888
71891518|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.095|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.146|0.044|0.0003
71891519|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.07|0.172||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.172|0.070|<0.0001
71749156|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|16.02||||0.0005|TWO_SIDED|95.0|3.39|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||75.68|3.39|0.0005
71749157|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.02||||0.1971|TWO_SIDED|95.0|0.56|16.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.17|0.56|0.1971
71749158|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0811|TWO_SIDED|95.0|0.83|22.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.27|0.83|0.0811
71781096|NCT02100514|143061653|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-10.4|STANDARD_ERROR_OF_MEAN|1.06||||95.0|-12.5|-8.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-8.3|-12.5|
71668035|NCT03718832|142852669|SUPERIORITY||Mean Difference (Net)|-8.912496|STANDARD_ERROR_OF_MEAN|21.34891||0.6766844|TWO_SIDED|95.0|-50.95358|33.12859||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||33.12859|-50.95358|0.6766844
71668036|NCT03718832|142852670|SUPERIORITY||Mean Difference (Net)|-1.870464|STANDARD_ERROR_OF_MEAN|2.024497||0.356123|TWO_SIDED|95.0|-5.851219|2.110291||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.110291|-5.851219|0.356123
71668037|NCT03718832|142852670|SUPERIORITY||Mean Difference (Net)|-0.8636408|STANDARD_ERROR_OF_MEAN|1.941141||0.6566494|TWO_SIDED|95.0|-4.681041|2.95376||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.95376|-4.681041|0.6566494
71668038|NCT03718832|142852670|SUPERIORITY||Mean Difference (Net)|-3.772051|STANDARD_ERROR_OF_MEAN|1.905125||0.0484944|TWO_SIDED|95.0|-7.519021|-0.0250809||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0250809|-7.519021|0.0484944
71668039|NCT03718832|142852670|SUPERIORITY||Mean Difference (Net)|-2.167034|STANDARD_ERROR_OF_MEAN|1.821244||0.234947|TWO_SIDED|95.0|-5.749627|1.415558||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.415558|-5.749627|0.234947
71749159|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|11.44||||0.0021|TWO_SIDED|95.0|2.43|53.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||53.94|2.43|0.0021
71749160|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.11||||0.137|TWO_SIDED|95.0|0.79|5.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.64|0.79|0.1370
71749161|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0181|TWO_SIDED|95.0|1.22|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.40|1.22|0.0181
71749162|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|6.43||||0.0002|TWO_SIDED|95.0|2.43|17.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.05|2.43|0.0002
71749163|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0003|TWO_SIDED|95.0|2.26|16.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.31|2.26|0.0003
71891520|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.064|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.166|0.064|<0.0001
71668040|NCT03718832|142852671|SUPERIORITY||Mean Difference (Net)|-0.5561156|STANDARD_ERROR_OF_MEAN|1.086759||0.6091477|TWO_SIDED|95.0|-2.693002|1.58077||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.58077|-2.693002|0.6091477
71668041|NCT03718832|142852671|SUPERIORITY||Mean Difference (Net)|-0.3787962|STANDARD_ERROR_OF_MEAN|1.032547||0.713942|TWO_SIDED|95.0|-2.409379|1.651786||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.651786|-2.409379|0.713942
71668042|NCT03718832|142852671|SUPERIORITY||Mean Difference (Net)|0.4989275|STANDARD_ERROR_OF_MEAN|1.053869||0.6362064|TWO_SIDED|95.0|-1.573807|2.571662||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||2.571662|-1.573807|0.6362064
71749164|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3241|TWO_SIDED|95.0|0.61|4.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.49|0.61|0.3241
71749165|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.85||||0.2249|TWO_SIDED|95.0|0.68|5.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.03|0.68|0.2249
71749166|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.53||||0.0096|TWO_SIDED|95.0|1.36|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.18|1.36|0.0096
71749167|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.35||||0.0768|TWO_SIDED|95.0|0.91|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.05|0.91|0.0768
71668043|NCT03718832|142852671|SUPERIORITY||Mean Difference (Net)|1.146286|STANDARD_ERROR_OF_MEAN|1.048105||0.2748884|TWO_SIDED|95.0|-0.9154561|3.208027||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3.208027|-0.9154561|0.2748884
71749168|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.91||||0.00251|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.39|1.14|0.00251
71749169|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0002|TWO_SIDED|95.0|2.3|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.57|2.30|0.0002
71749170|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|7.29|||<|0.0001|TWO_SIDED|95.0|2.7|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||19.71|2.70|<0.0001
71749171|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.14||||0.1144|TWO_SIDED|95.0|0.83|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.50|0.83|0.1144
71749172|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1341|TWO_SIDED|95.0|0.8|5.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.30|0.80|0.1341
71781097|NCT02100514|143061654|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|2.6|STANDARD_ERROR_OF_MEAN|0.52||||95.0|1.6|3.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.6|1.6|
71781098|NCT02100514|143061655|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.08||||95.0|-1.8|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.8|
71781099|NCT02100514|143061655|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.1||||95.0|-1.6|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.6|
71668044|NCT03718832|142852672|SUPERIORITY||Mean Difference (Net)|0.3232407|STANDARD_ERROR_OF_MEAN|0.3695066||0.3823224|TWO_SIDED|95.0|-0.4036366|1.050118||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.050118|-0.4036366|0.3823224
71749173|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0017|TWO_SIDED|95.0|1.75|11.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.22|1.75|0.0017
71749174|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1488|TWO_SIDED|95.0|0.77|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.50|0.77|0.1488
71749175|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0043|TWO_SIDED|95.0|1.54|10.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.30|1.54|0.0043
71749176|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.53||||0.0005|TWO_SIDED|95.0|2.1|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.57|2.10|0.0005
71749177|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.0001|TWO_SIDED|95.0|4.85|43.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.58|4.85|<0.0001
71781100|NCT02100514|143061655|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-1.4|STANDARD_ERROR_OF_MEAN|0.12||||95.0|-1.6|-1.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.2|-1.6|
71781101|NCT02100514|143061656|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.4|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.4|
71749178|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0262|TWO_SIDED|95.0|1.14|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.68|1.14|0.0262
71668045|NCT03718832|142852672|SUPERIORITY||Mean Difference (Net)|0.2619965|STANDARD_ERROR_OF_MEAN|0.3729922||0.4829339|TWO_SIDED|95.0|-0.4718566|0.9958495||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.9958495|-0.4718566|0.4829339
71749179|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0009|TWO_SIDED|95.0|1.95|13.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.19|1.95|0.0009
71749180|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0006|TWO_SIDED|95.0|2.06|13.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.80|2.06|0.0006
71749181|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3673|TWO_SIDED|95.0|0.61|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||3.75|0.61|0.3673
71749182|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1207|TWO_SIDED|95.0|0.83|4.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.91|0.83|0.1207
71749183|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0011|TWO_SIDED|95.0|1.9|13.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.21|1.90|0.0011
71749184|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|9.19|||<|0.0001|TWO_SIDED|95.0|3.08|27.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||27.38|3.08|<0.0001
71749185|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0594|TWO_SIDED|95.0|0.97|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.86|0.97|0.0594
71749186|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.47||||0.05|TWO_SIDED|95.0|1.0|6.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.09|1.00|0.0500
71749187|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.03|1.29|0.0123
71749188|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2243|TWO_SIDED|95.0|0.71|4.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.37|0.71|0.2243
71749189|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0976|TWO_SIDED|95.0|0.87|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.24|0.87|0.0976
71749190|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.25|16.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.44|2.25|0.0004
71749191|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|9.13|||<|0.0001|TWO_SIDED|95.0|3.04|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.40|3.04|<0.0001
71749192|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1237|TWO_SIDED|95.0|0.82|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.17|0.82|0.1237
71749193|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0226|TWO_SIDED|95.0|1.16|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.41|1.16|0.0226
71749194|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0069|TWO_SIDED|95.0|1.42|8.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.91|1.42|0.0069
71749195|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1666|TWO_SIDED|95.0|0.76|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.75|0.76|0.1666
71749196|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0317|TWO_SIDED|95.0|1.09|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|1.09|0.0317
71749197|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0011|TWO_SIDED|95.0|1.94|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.39|1.94|0.0011
71749198|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0001|TWO_SIDED|95.0|2.81|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||25.46|2.81|0.0001
71749199|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1142|TWO_SIDED|95.0|0.84|5.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.27|0.84|0.1142
71749200|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.91||||0.025|TWO_SIDED|95.0|1.14|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.39|1.14|0.0250
71749201|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0166|TWO_SIDED|95.0|1.23|7.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.75|1.23|0.0166
71749202|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6033|TWO_SIDED|95.0|0.52|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.11|0.52|0.6033
71781102|NCT02100514|143061656|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.02||||95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
71891521|NCT01431287|143304566|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.026||0.8241|TWO_SIDED|95.0|-0.045|0.057||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.057|-0.045|0.8241
71781103|NCT02100514|143061656|SUPERIORITY_OR_OTHER||LS mean difference compared to placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.04||||95.0|-0.4|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.4|
71749203|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.05||||0.117|TWO_SIDED|95.0|0.84|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.02|0.84|0.1170
71749204|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.69||||0.04|TWO_SIDED|95.0|1.05|6.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.91|1.05|0.0400
71749205|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.61||||0.002|TWO_SIDED|95.0|1.88|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.72|1.88|0.0020
71749206|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.35||||0.5177|TWO_SIDED|95.0|0.54|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.54|0.5177
71749207|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2117|TWO_SIDED|95.0|0.72|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.48|0.72|0.2117
71749208|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0426|TWO_SIDED|95.0|1.03|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.67|1.03|0.0426
71781104|NCT02100514|143061657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.9||||||95.0|32.08|90.59||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||90.59|32.08|
71668046|NCT03718832|142852672|SUPERIORITY||Mean Difference (Net)|-0.6983982|STANDARD_ERROR_OF_MEAN|0.3476441||0.045506|TWO_SIDED|95.0|-1.382737|-0.0140597||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||-0.0140597|-1.382737|0.045506
71749209|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3508|TWO_SIDED|95.0|0.62|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.82|0.62|0.3508
71781105|NCT02100514|143061657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.0||||||95.0|11.15|26.07||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||26.07|11.15|
71668047|NCT03718832|142852672|SUPERIORITY||Mean Difference (Net)|-0.6239824|STANDARD_ERROR_OF_MEAN|0.3336405||0.0625551|TWO_SIDED|95.0|-1.280906|0.0329412||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0329412|-1.280906|0.0625551
71749210|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4431|TWO_SIDED|95.0|0.58|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.45|0.58|0.4431
71749211|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|4.27||||0.005|TWO_SIDED|95.0|1.55|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.78|1.55|0.0050
71749212|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0023|TWO_SIDED|95.0|1.84|16.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||16.30|1.84|0.0023
71749213|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5663|TWO_SIDED|95.0|0.52|3.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.32|0.52|0.5663
71781106|NCT02100514|143061657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.1||||||95.0|6.18|13.48||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||13.48|6.18|
71781107|NCT02100514|143061658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|156.4||||||95.0|48.84|501.11||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||501.11|48.84|
71781108|NCT02100514|143061658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|110.8||||||95.0|39.77|308.46||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||308.46|39.77|
71781109|NCT02100514|143061658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.3||||||95.0|19.52|96.13||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||96.13|19.52|
71835286|NCT04732494|143175372|OTHER||LS Mean Difference|-10.8|||||TWO_SIDED|95.0|-27.8|6.3||||||Analysis of Change from Baseline in Dysphagia at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.3|-27.8|
71668048|NCT03718832|142852673|SUPERIORITY||Mean Difference (Net)|2.276579|STANDARD_ERROR_OF_MEAN|1.636162||0.1650343|TWO_SIDED|95.0|-0.9420086|5.495166||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||5.495166|-0.9420086|0.1650343
71668049|NCT03718832|142852673|SUPERIORITY||Mean Difference (Net)|1.989458|STANDARD_ERROR_OF_MEAN|1.359013||0.1442126|TWO_SIDED|95.0|-0.6843682|4.663284||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||4.663284|-0.6843682|0.1442126
71749214|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0461|TWO_SIDED|95.0|1.02|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.83|1.02|0.0461
71781110|NCT00724932|143061665|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|3.4|||<|0.0001|TWO_SIDED|95.0|2.8|4.1||Testing was performed using a two-sided test at the 0.05 significance level. There was only one primary comparison, therefore no adjustment for multiplicity was required.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.9 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a two-way analysis of variance (ANOVA) model adjusted for treatment group and trial site.||4.1|2.8|<0.0001
71835287|NCT04732494|143175372|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-7.3|6.6||||||Analysis of Change from Baseline in Eating at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||6.6|-7.3|
71668050|NCT03718832|142852673|SUPERIORITY||Mean Difference (Net)|-1.579811|STANDARD_ERROR_OF_MEAN|0.739612||0.0335498|TWO_SIDED|95.0|-3.03574|-0.1238828||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.1238828|-3.03574|0.0335498
71781111|NCT00724932|143061666|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|2.1|2.8||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.7 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.7 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||2.8|2.1|<0.0001
71781112|NCT00724932|143061674|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.5|3.4||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.8 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.8 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.||3.4|2.5|<0.0001
71781113|NCT01081678|143061699|OTHER|||||||0.1983|||||||F-test|The p-value is based on F-test of multi-linear contrasts at Week 6 through Week 20.||The primary analysis was based on a test for linear trend in dose response at weeks 6, 12, 16, and 20. To account for multiple comparisons over time points, the primary analysis used a size α = 0.05 F-test with 4 degrees of freedom for the contrasts at Weeks 6, 12, 16, and 20.||||0.1983
71781114|NCT02499783|143061705|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7|||Cochran-Mantel-Haenszel|Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Risk difference = (adalimumab 160/80 mg - placebo). Stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|||41.7|19.2|<0.001
71781115|NCT02499783|143061706|SUPERIORITY||Risk Difference Compared to 30%|34.6|||<|0.001|TWO_SIDED|95.0|26.2|42.4|||One Sample Exact Test|The one sample Exact test was performed by comparing it to the clinically meaningful remission rate of 30%.||||42.4|26.2|< 0.001
71781116|NCT02499783|143061707|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||43.6|23.2|< 0.001
71781117|NCT02499783|143061711|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||54.2|26.7|< 0.001
71781118|NCT02499783|143061712|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||63.5|36.9|< 0.001
71781119|NCT02499783|143061713|SUPERIORITY||Adjusted Risk Difference|27.6|||<|0.001|TWO_SIDED|95.0|18.2|37.0||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||37.0|18.2|< 0.001
71781120|NCT02499783|143061715|SUPERIORITY||Adjusted Risk Difference|19.6||||0.002|TWO_SIDED|95.0|7.1|32.1||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||32.1|7.1|0.002
71781121|NCT02499783|143061717|SUPERIORITY||Least Squares Mean Difference|-385.2|||<|0.001|TWO_SIDED|95.0|-598.81|-171.5||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||||-171.50|-598.81|< 0.001
71668051|NCT03718832|142852673|SUPERIORITY||Mean Difference (Net)|-1.764632|STANDARD_ERROR_OF_MEAN|0.8545352||0.0398937|TWO_SIDED|95.0|-3.447175|-0.0820899||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||-0.0820899|-3.447175|0.0398937
71835288|NCT04732494|143175372|OTHER||LS Mean Difference|-9.4|||||TWO_SIDED|95.0|-18.5|-0.3||||||Analysis of Change from Baseline in Eating at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||-0.3|-18.5|
71835289|NCT04732494|143175372|OTHER||LS Mean Difference|2.3|||||TWO_SIDED|95.0|-6.7|11.2||||||Analysis of Change from Baseline in Reflux at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||11.2|-6.7|
71835290|NCT04732494|143175372|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-11.8|9.0||||||Analysis of Change from Baseline in Reflux at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||9.0|-11.8|
71749215|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0552|TWO_SIDED|95.0|0.98|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.38|0.98|0.0552
71749216|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1536|TWO_SIDED|95.0|0.78|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.88|0.78|0.1536
71749217|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.69||||0.2575|TWO_SIDED|95.0|0.68|4.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.20|0.68|0.2575
71749218|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0096|TWO_SIDED|95.0|1.38|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.11|1.38|0.0096
71749219|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|8.48||||0.0003|TWO_SIDED|95.0|2.69|26.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||26.76|2.69|0.0003
71749220|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1047|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.1047
71749221|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.91||||0.006|TWO_SIDED|95.0|1.48|10.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.35|1.48|0.0060
71749222|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0414|TWO_SIDED|95.0|1.04|6.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.71|1.04|0.0414
71749223|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0809|TWO_SIDED|95.0|0.9|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.89|0.90|0.0809
71749224|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2377|TWO_SIDED|95.0|0.69|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.34|0.69|0.2377
71749225|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0087|TWO_SIDED|95.0|1.44|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.34|1.44|0.0087
71749226|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0022|TWO_SIDED|95.0|1.9|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||18.94|1.90|0.0022
71835291|NCT04732494|143175372|OTHER||LS Mean Difference|0.7|||||TWO_SIDED|95.0|-7.0|8.5||||||Analysis of Change from Baseline in Pain at Cycle 5. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||8.5|-7.0|
71835292|NCT04732494|143175372|OTHER||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.3|1.7||||||Analysis of Change from Baseline in Pain at Cycle 7. The mixed effect model analysis included the questionnaire score as dependent variable; baseline score, stratification factors, treatment arm, visit, and treatment arm by visit interaction as fixed effects; and visit as a repeated measure, with an unstructured covariance structure.||1.7|-12.3|
71891522|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.158|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.208||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.208|0.108|<0.0001
71668052|NCT03718832|142852674|SUPERIORITY||Mean Difference (Net)|-0.6294078|STANDARD_ERROR_OF_MEAN|0.4409795||0.1544491|TWO_SIDED|95.0|-1.496923|0.238107||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.238107|-1.496923|0.1544491
71749227|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4788|TWO_SIDED|95.0|0.55|3.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.55|0.55|0.4788
71749228|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.98||||0.0074|TWO_SIDED|95.0|1.45|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.94|1.45|0.0074
71749229|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0187|TWO_SIDED|95.0|1.22|8.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.75|1.22|0.0187
71749230|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3443|TWO_SIDED|95.0|0.62|4.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.00|0.62|0.3443
71749231|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.66||||0.2867|TWO_SIDED|95.0|0.65|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.22|0.65|0.2867
71749232|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.12||||0.0044|TWO_SIDED|95.0|1.66|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.78|1.66|0.0044
71749233|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0038|TWO_SIDED|95.0|1.74|17.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.87|1.74|0.0038
71749234|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.09||||0.1424|TWO_SIDED|95.0|0.78|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.60|0.78|0.1424
71749235|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0191|TWO_SIDED|95.0|1.22|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.07|1.22|0.0191
71749236|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0244|TWO_SIDED|95.0|1.16|8.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.56|1.16|0.0244
71749237|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1462|TWO_SIDED|95.0|0.71|9.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.67|0.71|0.1462
71749238|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7403|TWO_SIDED|95.0|0.32|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.97|0.32|0.7403
71749239|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2144|TWO_SIDED|95.0|0.61|9.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.07|0.61|0.2144
71749240|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4321|TWO_SIDED|95.0|0.44|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.96|0.44|0.4321
71668053|NCT03718832|142852674|SUPERIORITY||Mean Difference (Net)|-0.6081765|STANDARD_ERROR_OF_MEAN|0.451915||0.1793486|TWO_SIDED|95.0|-1.497352|0.2809987||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2809987|-1.497352|0.1793486
71891523|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.025||0.0048|TWO_SIDED|95.0|0.022|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.122|0.022|0.0048
71668054|NCT03718832|142852674|SUPERIORITY||Mean Difference (Net)|-0.1731023|STANDARD_ERROR_OF_MEAN|0.4024787||0.6674618|TWO_SIDED|95.0|-0.9653829|0.6191784||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.6191784|-0.9653829|0.6674618
71749241|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1778|TWO_SIDED|95.0|0.66|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.75|0.66|0.1778
71749242|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8016|TWO_SIDED|95.0|0.28|5.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.20|0.28|0.8016
71749243|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|2.62||||0.1486|TWO_SIDED|95.0|0.71|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.71|0.1486
71749244|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.51||||0.2881|TWO_SIDED|95.0|0.15|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.77|0.15|0.2881
71749245|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1217|TWO_SIDED|95.0|0.1|1.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.31|0.10|0.1217
71749246|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.36||||0.1027|TWO_SIDED|95.0|0.07|1.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.28|0.07|0.1027
71749247|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.18||||0.0428|TWO_SIDED|95.0|0.03|0.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||0.94|0.03|0.0428
71749248|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5943|TWO_SIDED|95.0|0.21|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.21|0.5943
71749249|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.94||||0.928|TWO_SIDED|95.0|0.27|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.27|0.9280
71781122|NCT02499783|143061718|SUPERIORITY||Adjusted Risk Difference|9.8||||0.001|TWO_SIDED|95.0|3.9|15.8||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline.|||15.8|3.9|0.001
71781123|NCT02499783|143061720|SUPERIORITY||Adjusted Risk Difference|18.4|||<|0.001|TWO_SIDED|95.0|8.2|28.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 2||28.6|8.2|< 0.001
71781124|NCT02499783|143061720|SUPERIORITY||Adjusted Risk Difference|30.4|||<|0.001|TWO_SIDED|95.0|19.2|41.7||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 4||41.7|19.2|< 0.001
71749250|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.94||||0.916|TWO_SIDED|95.0|0.3|2.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.94|0.30|0.9160
71749251|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2262|TWO_SIDED|95.0|0.11|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.11|0.2262
71781125|NCT02499783|143061722|SUPERIORITY||Adjusted Risk Difference|21.4|||<|0.001|TWO_SIDED|95.0|12.6|30.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2||30.2|12.6|< 0.001
71749252|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2682|TWO_SIDED|95.0|0.13|1.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.75|0.13|0.2682
71749253|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.4||||0.2344|TWO_SIDED|95.0|0.09|1.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.81|0.09|0.2344
71749254|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.22||||0.0835|TWO_SIDED|95.0|0.04|1.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.22|0.04|0.0835
71781126|NCT02499783|143061722|SUPERIORITY||Adjusted Risk Difference|33.4|||<|0.001|TWO_SIDED|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4||43.6|23.2|< 0.001
71781127|NCT02499783|143061724|SUPERIORITY||Adjusted Risk Difference|21.7||||0.001|TWO_SIDED|95.0|8.7|34.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2||34.6|8.7|0.001
71781128|NCT02499783|143061724|SUPERIORITY||Adjusted Risk Difference|40.4|||<|0.001|TWO_SIDED|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4||54.2|26.7|< 0.001
71781129|NCT02499783|143061726|SUPERIORITY||Adjusted Risk Difference|31.4|||<|0.001|TWO_SIDED|95.0|19.6|43.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2||43.2|19.6|< 0.001
71749255|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6322|TWO_SIDED|95.0|0.19|2.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.72|0.19|0.6322
71749256|NCT03192176|143005302|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4845|TWO_SIDED|95.0|0.2|2.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.17|0.20|0.4845
71781130|NCT02499783|143061726|SUPERIORITY||Adjusted Risk Difference|50.2|||<|0.001|TWO_SIDED|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI \<= 300 and CDAI \>300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4||63.5|36.9|< 0.001
71749257|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9587|TWO_SIDED|95.0|0.06|17.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.98|0.06|0.9587
71781131|NCT02499783|143061728|SUPERIORITY||Least Squares Mean Difference|-43.34|||<|0.001|TWO_SIDED|95.0|-59.39|-27.3||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 2||-27.30|-59.39|< 0.001
71749258|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9895|TWO_SIDED|95.0|0.06|16.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.89|0.06|0.9895
71668055|NCT03718832|142852674|SUPERIORITY||Mean Difference (Net)|-0.2208031|STANDARD_ERROR_OF_MEAN|0.4196435||0.5992113|TWO_SIDED|95.0|-1.047063|0.6054567||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.6054567|-1.047063|0.5992113
71749259|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0736|TWO_SIDED|95.0|0.83|63.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||63.32|0.83|0.0736
71749260|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|7.08||||0.0767|TWO_SIDED|95.0|0.81|61.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||61.78|0.81|0.0767
71781132|NCT02499783|143061728|SUPERIORITY||Least Squares Mean Difference|-66.63|||<|0.001|TWO_SIDED|95.0|-84.2|-49.06||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 4||-49.06|-84.20|< 0.001
71781133|NCT02499783|143061730|SUPERIORITY||Least Squares Mean Difference|-13.921|||<|0.001|TWO_SIDED|95.0|-19.183|-8.659||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 2||-8.659|-19.183|< 0.001
71781134|NCT02499783|143061730|SUPERIORITY||Least Squares Mean Difference|-16.844|||<|0.001|TWO_SIDED|95.0|-21.206|-12.483||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI \<= 300, \> 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 4||-12.483|-21.206|< 0.001
71781135|NCT04457336|143061741|OTHER|Assessment of dose response for change from baseline in log 17-OHP after 12 weeks on double-blind, placebo-controlled treatment (Week 18). Results were obtained by using a repeated measures random coefficient mixed-effects model and are reported as the -2loglikelihood results for both the full (including interaction terms) and reduced (excluding interaction terms) models.||||||0.8051||||||Dose response p-value|Mixed Models Analysis|The result for the -2loglikelihood full model was -580.2550766 log(ng/dL) and -583.2846546 log(ng/dL) for the reduced model.||||||0.8051
71781136|NCT00963937|143061818|SUPERIORITY_OR_OTHER||Percent Difference|-7.49||||0.345|TWO_SIDED|95.0|-23.02|8.04||Multiplicity was not considered because the primary analysis included a single statistical comparison.|Chi-squared||Percent difference = sumatriptan pooled group minus the placebo group|||8.04|-23.02|0.345
71749261|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.51||||0.288|TWO_SIDED|95.0|0.35|35.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.49|0.35|0.2880
71749262|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.96||||0.5894|TWO_SIDED|95.0|0.17|22.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.47|0.17|0.5894
71749263|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.45||||0.3093|TWO_SIDED|95.0|0.44|13.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.78|0.44|0.3093
71749264|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1606|TWO_SIDED|95.0|0.62|17.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.58|0.62|0.1606
71781137|NCT04010695|143061842|OTHER||||||<|0.001|||||||K-sample test|The p-value was calculated using a nonparametric k-sample test on the equality of medians.||Comparison of SD Biosensor POC G6PD test results for capillary and venous samples||||<0.001
71781138|NCT01235689|143061843|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by Screening smoking status (yes or no) and weight (\< 70 kg or ≥ 70 kg).||||||0.010
71781139|NCT01235689|143061844|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.014
71781140|NCT01235689|143061845|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.006
71781141|NCT01235689|143061846|SUPERIORITY|||||||0.01|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.010
71781142|NCT01235689|143061847|SUPERIORITY|||||||0.299|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.299
71781143|NCT01235689|143061848|SUPERIORITY|||||||0.728|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.728
71781144|NCT01235689|143061849|SUPERIORITY|||||||0.067|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (\< 70 kg, ≥ 70 kg).||||||0.067
71781145|NCT01235689|143061850|SUPERIORITY||LS Mean Difference|-1.4||||0.116|TWO_SIDED|95.0|-3.2|0.4|||ANCOVA|Model included factors for treatment group, screening smoking status (yes or no), and weight (\< 70 kg, ≥ 70 kg), and Baseline values as covariate.||||0.4|-3.2|0.116
71781146|NCT01235689|143061852|SUPERIORITY||Cox Proportional Hazard|0.442||||0.012|TWO_SIDED|95.0|0.2|0.8|||Regression, Cox|||||0.8|0.2|0.012
71781147|NCT01235689|143061853|SUPERIORITY||Cox Proportional Hazard|1.45||||0.008|TWO_SIDED|95.0|1.1|1.9|||Regression, Cox|||||1.9|1.1|0.008
71781148|NCT01235689|143061854|SUPERIORITY||Cox Proportional Hazard|1.337||||0.052|TWO_SIDED|95.0|1.0|1.8|||Regression, Cox|||||1.8|1.0|0.052
71781149|NCT01235689|143061857|SUPERIORITY||Cox Proportional Hazard|0.823||||0.501|TWO_SIDED|95.0|0.5|1.5|||Regression, Cox|||||1.5|0.5|0.501
71781150|NCT01235689|143061858|SUPERIORITY||Cox Proportional Hazard|0.785||||0.459|TWO_SIDED|95.0|0.4|1.5|||Regression, Cox|||||1.5|0.4|0.459
71781151|NCT01235689|143061865|SUPERIORITY||Cox Proportional Hazard|0.423||||0.212|TWO_SIDED|95.0|0.1|1.6|||Regression, Cox|||||1.6|0.1|0.212
71781152|NCT00389597|143061876|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.||||||0.0021|||||||Farrington Manning|||1 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.||||0.0021
71781153|NCT00389597|143061876|NON_INFERIORITY_OR_EQUIVALENCE|The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.|||||<|0.0001|||||||Farrington-Manning|||"2 Level: Ho: pm-pc \<=-0.1 (inferiority) Alternative hypothesis: Ha: pm - pc \> -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc \<= 0 (not superior) Alternative hypothesis: Ha: pm-pc \>0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group."||||<0.0001
71781154|NCT00005044|143061877|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.45|TWO_SIDED|95.0|0.48|1.39|||Log Rank||Reference level = TAS x 8 weeks|Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.||1.39|0.48|0.45
71781155|NCT00005044|143061878|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.62|TWO_SIDED|95.0|0.79|1.15|||Log Rank|2-sided significance level of 0.05|Reference level = TAS x 8 weeks|With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.||1.15|0.79|0.62
71781156|NCT00005044|143061879|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.47|TWO_SIDED|95.0|0.85|1.08|||Log Rank|Significance level = 0.05|Reference level = TAS x 8 weeks|||1.08|0.85|0.47
71781157|NCT00005044|143061880|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.07|TWO_SIDED|95.0|0.4|1.05|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Locoregional progression||1.05|0.40|0.07
71835293|NCT03897686|143175374|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0003|TWO_SIDED|95.0|-274.96|-83.65||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||"It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.~The null hypothesis states that there is no difference between treatment groups in mean change from baseline to Week 25 in the total WOMAC score."||-83.65|-274.96|0.00030
71668056|NCT03718832|142852675|SUPERIORITY||Mean Difference (Net)|0.4824561|STANDARD_ERROR_OF_MEAN|0.423027||0.2549037|TWO_SIDED|95.0|-0.349686|1.314598||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.314598|-0.349686|0.2549037
71781158|NCT00005044|143061880|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.8|TWO_SIDED|95.0|0.68|1.66|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Distant metastasis||1.66|0.68|0.80
71781159|NCT00005044|143061881|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.74|TWO_SIDED|95.0|0.89|1.17|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Protocol definition||1.17|0.89|0.74
71781160|NCT00005044|143061881|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.77|TWO_SIDED|95.0|0.79|1.19|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Phoenix definition||1.19|0.79|0.77
71781161|NCT00005044|143061882|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.62|TWO_SIDED|95.0|0.64|1.3|||Log Rank|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|||1.30|0.64|0.62
71781162|NCT02935842|143061958|OTHER|||||||||||||||||First Reliable Change (RC), Reliable Change Index (RCI) were calculated on every individual score. Further, ANOVAs and t-tests were administered in order to verify differences between groups or interventions. Significance levels were set at p \< .05.|Reliable Change / Reliable Change Index according to Jacobson \& Truax (1991). There, on the basis of every individual score, the change in performance (i.e. BL-4Weeks/ BL-6Months) has been calculated and is reported with level of significance as well as effect size.|||
71781163|NCT02935842|143061958|OTHER|||||||0.05|||||||ANOVA|||||||.05
71835294|NCT03897686|143175374|SUPERIORITY|\[Not specified\]|LS-means difference|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~1\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade II"||-53.50|-305.11|0.0017
71781164|NCT02935842|143061962|OTHER|||||||0.05|||||||ANOVA|||||||.05
71781165|NCT02935842|143061964|OTHER|||||||0.05|||||||ANOVA|||||||.05
71781166|NCT02774954|143061965|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
71781167|NCT02774954|143061966|SUPERIORITY|||||||0.35|||||||ANOVA|||||||0.35
71781168|NCT04545385|143061968|OTHER||Odds Ratio (OR)|1.49||||0.7817|TWO_SIDED|95.0|0.545|4.071|||Regression, Logistic|||Analysis was performed using logistic regression with fixed effects for treatment, baseline FEV1, weight, age group, and gender.||4.071|0.545|0.7817
71781169|NCT02229383|143061988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.101|<|0.001|TWO_SIDED|95.0|-0.94|-0.54|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.54|-0.94|<0.001
71749265|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0019|TWO_SIDED|95.0|2.5|56.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||56.87|2.50|0.0019
71749266|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|14.4||||0.0008|TWO_SIDED|95.0|3.02|68.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||68.73|3.02|0.0008
71749267|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8803|TWO_SIDED|95.0|0.11|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.55|0.11|0.8803
71749268|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.98||||0.2096|TWO_SIDED|95.0|0.54|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.46|0.54|0.2096
71749269|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|7.69||||0.011|TWO_SIDED|95.0|1.6|37.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||37.11|1.60|0.0110
71749270|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0845|TWO_SIDED|95.0|0.86|11.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.11|0.86|0.0845
71749271|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1094|TWO_SIDED|95.0|0.79|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.13|0.79|0.1094
71749272|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|8.97||||0.0004|TWO_SIDED|95.0|2.68|30.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||30.07|2.68|0.0004
71749273|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0016|TWO_SIDED|95.0|2.1|24.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.09|2.10|0.0016
71781170|NCT02229383|143061989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.341|<|0.001|TWO_SIDED|95.0|-2.19|-0.85|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||-0.85|-2.19|<0.001
71749274|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4375|TWO_SIDED|95.0|0.44|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.64|0.44|0.4375
71749275|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.02||||0.0898|TWO_SIDED|95.0|0.84|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|0.84|0.0898
71749276|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0027|TWO_SIDED|95.0|1.9|21.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.06|1.90|0.0027
71749277|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1242|TWO_SIDED|95.0|0.78|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.64|0.78|0.1242
71749278|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0815|TWO_SIDED|95.0|0.88|8.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.03|0.88|0.0815
71781171|NCT02229383|143061990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.76|STANDARD_ERROR_OF_MEAN|5.754|<|0.001|TWO_SIDED|95.0|-39.07|-16.45|||ANCOVA|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.||||-16.45|-39.07|<0.001
71781172|NCT02229383|143061991|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
71781173|NCT02229383|143061992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.074|TWO_SIDED|95.0|-4.1|0.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.2|-4.1|0.074
71781174|NCT02229383|143061993|SUPERIORITY_OR_OTHER||Difference in percentages|20.0|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).||||||<0.001
71781175|NCT02229383|143061994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.13||0.11|TWO_SIDED|95.0|-4.0|0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c (\< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.||||0.4|-4.0|0.110
71749279|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|6.21||||0.0009|TWO_SIDED|95.0|2.11|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.27|2.11|0.0009
71749280|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0027|TWO_SIDED|95.0|1.78|15.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.64|1.78|0.0027
71749281|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.35||||0.6267|TWO_SIDED|95.0|0.41|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.46|0.41|0.6267
71749282|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0709|TWO_SIDED|95.0|0.92|8.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.38|0.92|0.0709
71749283|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0049|TWO_SIDED|95.0|1.59|13.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||13.59|1.59|0.0049
71749284|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.5||||0.5107|TWO_SIDED|95.0|0.45|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.98|0.45|0.5107
71749285|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1297|TWO_SIDED|95.0|0.78|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.22|0.78|0.1297
71749286|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|7.04||||0.0005|TWO_SIDED|95.0|2.34|21.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.22|2.34|0.0005
71749287|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0001|TWO_SIDED|95.0|2.82|25.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||25.63|2.82|0.0001
71749288|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.84||||0.299|TWO_SIDED|95.0|0.58|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.58|0.2990
71749289|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.38||||0.1355|TWO_SIDED|95.0|0.76|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.76|0.1355
71749290|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|5.17||||0.0028|TWO_SIDED|95.0|1.76|15.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.14|1.76|0.0028
71749291|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7422|TWO_SIDED|95.0|0.41|3.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.47|0.41|0.7422
71781176|NCT00191139|143062034|SUPERIORITY_OR_OTHER||survival rate|40.6||||||95.0|23.8|56.8|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||56.8|23.8|
71781177|NCT00191139|143062034|SUPERIORITY_OR_OTHER||survival rate|55.7||||||95.0|36.8|70.9|||normal approximation|Count the number of surviving participants at each time interval to get survival rates.||||70.9|36.8|
71668057|NCT03718832|142852675|SUPERIORITY||Mean Difference (Net)|0.3545817|STANDARD_ERROR_OF_MEAN|0.4230741||0.4025977|TWO_SIDED|95.0|-0.4777863|1.186949||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.186949|-0.4777863|0.4025977
71749292|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.44||||0.075|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.52|0.91|0.0750
71749293|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0006|TWO_SIDED|95.0|2.16|16.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.67|2.16|0.0006
71781178|NCT00191139|143062035|SUPERIORITY_OR_OTHER||Response Rate|75.0||||||95.0|56.6|88.5|||normal approximation|||||88.5|56.6|
71781179|NCT00191139|143062035|SUPERIORITY_OR_OTHER||Response rate|84.4||||||95.0|67.2|94.7|||Normal approximation|||||94.7|67.2|
71781180|NCT00191139|143062036|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Log Rank|||||||0.08
71749294|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|7.63||||0.0001|TWO_SIDED|95.0|2.69|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.65|2.69|0.0001
71749295|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8405|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.23|0.38|0.8405
71749296|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6257|TWO_SIDED|95.0|0.45|3.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.79|0.45|0.6257
71749297|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.92||||0.006|TWO_SIDED|95.0|1.48|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.36|1.48|0.0060
71749298|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.74||||0.3556|TWO_SIDED|95.0|0.54|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.68|0.54|0.3556
71749299|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.67||||0.019|TWO_SIDED|95.0|1.24|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.90|1.24|0.0190
71749300|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|9.9|||<|0.0001|TWO_SIDED|95.0|3.2|30.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||30.68|3.20|<0.0001
71749301|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|14.81|||<|0.0001|TWO_SIDED|95.0|4.67|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||47.05|4.67|<0.0001
71749302|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1936|TWO_SIDED|95.0|0.68|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.68|0.1936
71781181|NCT00191139|143062037|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Log Rank|||||||0.38
71749303|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0335|TWO_SIDED|95.0|1.1|10.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.47|1.10|0.0335
71749304|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0009|TWO_SIDED|95.0|2.1|18.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.17|2.10|0.0009
71749305|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|95.0|0.34|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.39|0.34|0.8330
71781182|NCT03846804|143062041|OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71781183|NCT00345839|143062054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.112||||||p-value\<0.044 considered significant|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.112
71781184|NCT00345839|143062054|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.85|1.02|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.02|0.85|
71749306|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.56||||0.341|TWO_SIDED|95.0|0.62|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.62|0.3410
71749307|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0075|TWO_SIDED|95.0|1.42|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.69|1.42|0.0075
71749308|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|4.86||||0.002|TWO_SIDED|95.0|1.78|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.26|1.78|0.0020
71749309|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6216|TWO_SIDED|95.0|0.29|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.10|0.29|0.6216
71781185|NCT00345839|143062055|SUPERIORITY_OR_OTHER_LEGACY|||||||0.249||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.249
71781186|NCT00345839|143062055|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.85|1.04|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.04|0.85|
71749310|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.43||||0.4615|TWO_SIDED|95.0|0.55|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.71|0.55|0.4615
71749311|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0281|TWO_SIDED|95.0|1.12|7.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.19|1.12|0.0281
71749312|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8028|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.8028
71781187|NCT00345839|143062056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.800
71781188|NCT00345839|143062056|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.19|0.79|
71781189|NCT00345839|143062057|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.283
71781190|NCT00345839|143062057|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.58|1.18|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.18|0.58|
71781191|NCT00345839|143062058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.034
71749313|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.21||||0.6846|TWO_SIDED|95.0|0.48|3.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.07|0.48|0.6846
71781192|NCT00345839|143062058|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.68|0.99|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.99|0.68|
71781193|NCT00345839|143062059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.190
71668058|NCT03718832|142852675|SUPERIORITY||Mean Difference (Net)|-0.0102657|STANDARD_ERROR_OF_MEAN|0.4695747||0.9825739|TWO_SIDED|95.0|-0.9346107|0.9140792||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.9140792|-0.9346107|0.9825739
71749314|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0149|TWO_SIDED|95.0|1.26|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|1.26|0.0149
71749315|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|5.64||||0.0009|TWO_SIDED|95.0|2.03|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.65|2.03|0.0009
71749316|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6434|TWO_SIDED|95.0|0.29|2.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.15|0.29|0.6434
71749317|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4784|TWO_SIDED|95.0|0.54|3.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.69|0.54|0.4784
71749318|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0955|TWO_SIDED|95.0|0.87|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.55|0.87|0.0955
71781194|NCT00345839|143062059|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.72|
71781195|NCT00345839|143062060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.277
71749319|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.06||||0.9082|TWO_SIDED|95.0|0.4|2.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.79|0.40|0.9082
71749320|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6478|TWO_SIDED|95.0|0.48|3.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.21|0.48|0.6478
71781196|NCT00345839|143062060|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.80|
71781197|NCT00345839|143062061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.607||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.607
71781198|NCT00345839|143062061|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.40|0.82|
71749321|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0104|TWO_SIDED|95.0|1.35|9.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.82|1.35|0.0104
71749322|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|6.66||||0.0004|TWO_SIDED|95.0|2.34|18.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.94|2.34|0.0004
71749323|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.91||||0.856|TWO_SIDED|95.0|0.34|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.45|0.34|0.8560
71781199|NCT00345839|143062062|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||0.218
71781200|NCT00345839|143062062|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.75|1.07|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||1.07|0.75|
71781201|NCT00345839|143062063|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.||||||<0.001
71781202|NCT00345839|143062063|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.36|0.54|||Regression, Cox|Stratified by history of diabetes and country.|HR is cinacalcet vs placebo.|||0.54|0.36|
71891524|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.101|0.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.200|0.101|<0.0001
71668059|NCT03718832|142852675|SUPERIORITY||Mean Difference (Net)|-0.0340184|STANDARD_ERROR_OF_MEAN|0.4869778||0.9443607|TWO_SIDED|95.0|-0.9928399|0.9248032||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.9248032|-0.9928399|0.9443607
71668060|NCT03718832|142852676|SUPERIORITY||Mean Difference (Net)|0.160997|STANDARD_ERROR_OF_MEAN|0.0376773||2.52e-05|TWO_SIDED|95.0|0.0868814|0.2351126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.2351126|0.0868814|0.0000252
71668061|NCT03718832|142852676|SUPERIORITY||Mean Difference (Net)|0.1691707|STANDARD_ERROR_OF_MEAN|0.0391132||2.04e-05|TWO_SIDED|95.0|0.0922183|0.2461232||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.2461232|0.0922183|0.0000204
71749324|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3319|TWO_SIDED|95.0|0.62|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.17|0.62|0.3319
71781203|NCT01960400|143062064|SUPERIORITY_OR_OTHER|||||||0.065||||||"The statistical signifiance level : p\<0.05. After treatment (T1) Pain severity p=0.065~Sub-scale:~* Present pain p=0.046\*~* Average pain p=0.381~* Most intense pain p=0.064~* Least intense pain p=0.142"|ANOVA|To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.||For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).||||0.065
71781204|NCT01960400|143062065|SUPERIORITY_OR_OTHER|||||||0.049||||||interaction group X time|ANOVA|||||||0.049
71781205|NCT01960400|143062066|SUPERIORITY_OR_OTHER|||||||0.035||||||interaction group X time|ANOVA|||||||0.035
71749325|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0747|TWO_SIDED|95.0|0.92|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.95|0.92|0.0747
71749326|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8986|TWO_SIDED|95.0|0.41|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.76|0.41|0.8986
71781206|NCT01960400|143062067|SUPERIORITY_OR_OTHER|||||||0.046||||||interaction group X time|ANOVA|||||||0.046
71781207|NCT00743483|143062068|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||t-test, 2 sided|||||||0.2179
71668062|NCT03718832|142852676|SUPERIORITY||Mean Difference (Net)|0.0028595|STANDARD_ERROR_OF_MEAN|0.0261733||0.9130816|TWO_SIDED|95.0|-0.0486635|0.0543825||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0543825|-0.0486635|0.9130816
71781208|NCT01466153|143062069|SUPERIORITY_OR_OTHER|||||||0.4475|||||||Cochran-Mantel-Haenszel|||||||0.4475
71781209|NCT01466153|143062073|SUPERIORITY_OR_OTHER|||||||0.3206|||||||Cochran-Mantel-Haenszel|||||||0.3206
71781210|NCT01466153|143062074|SUPERIORITY_OR_OTHER|||||||0.313|||||||Cochran-Mantel-Haenszel|||||||0.3130
71668063|NCT03718832|142852676|SUPERIORITY||Mean Difference (Net)|0.0166325|STANDARD_ERROR_OF_MEAN|0.0271062||0.5400053|TWO_SIDED|95.0|-0.0367394|0.0700045||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0700045|-0.0367394|0.5400053
71749327|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9712|TWO_SIDED|95.0|0.38|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.53|0.38|0.9712
71749328|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|3.31||||0.091|TWO_SIDED|95.0|1.22|8.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.98|1.22|0.0910
71781211|NCT01466153|143062076|SUPERIORITY_OR_OTHER|||||||0.9527|||||||Log Rank|||||||0.9527
71781212|NCT03281577|143062118|SUPERIORITY||Least Squares Mean Differences|-25.81||||0.0012|TWO_SIDED|95.0|-41.757|-9.858||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% confidence interval (CI) are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as covariate.|||-9.858|-41.757|0.0012
71781213|NCT03281577|143062118|SUPERIORITY||Least Squares Mean Differences|-27.52||||0.0018|TWO_SIDED|95.0|-45.224|-9.813||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-9.813|-45.224|0.0018
71781214|NCT03281577|143062118|SUPERIORITY||Least Squares Mean Differences|-41.76|||<|0.0001|TWO_SIDED|95.0|-59.616|-23.902||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-23.902|-59.616|<.0001
71668064|NCT03718832|142852677|SUPERIORITY||Mean Difference (Net)|0.0511555|STANDARD_ERROR_OF_MEAN|0.016316||0.0018721|TWO_SIDED|95.0|0.0190582|0.0832528||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0832528|0.0190582|0.0018721
71668065|NCT03718832|142852677|SUPERIORITY||Mean Difference (Net)|0.0433081|STANDARD_ERROR_OF_MEAN|0.0168497||0.0106231|TWO_SIDED|95.0|0.0101555|0.0764607||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0764607|0.0101555|0.0106231
71668066|NCT03718832|142852677|SUPERIORITY||Mean Difference (Net)|0.0138256|STANDARD_ERROR_OF_MEAN|0.0171112||0.4197898|TWO_SIDED|95.0|-0.0198584|0.0475096||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0475096|-0.0198584|0.4197898
71749329|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|5.68||||0.0011|TWO_SIDED|95.0|2.01|16.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.06|2.01|0.0011
71749330|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8466|TWO_SIDED|95.0|0.35|2.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.39|0.35|0.8466
71749331|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1409|TWO_SIDED|95.0|0.79|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.21|0.79|0.1409
71781215|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|0.72||||0.259|TWO_SIDED|95.0|-0.364|1.795||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.795|-0.364|0.2590
71781216|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|1.27||||0.028|TWO_SIDED|95.0|0.119|2.418||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||2.418|0.119|0.0280
71749332|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1212|TWO_SIDED|95.0|0.82|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.25|0.82|0.1212
71781217|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|0.45||||0.6882|TWO_SIDED|95.0|-0.757|1.66||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 4 Hours, Day 2||1.660|-0.757|0.6882
71749333|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.48||||0.4269|TWO_SIDED|95.0|0.56|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.88|0.56|0.4269
71749334|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5454|TWO_SIDED|95.0|0.52|3.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.49|0.52|0.5454
71749335|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0595|TWO_SIDED|95.0|0.96|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.15|0.96|0.0595
71749336|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0041|TWO_SIDED|95.0|1.62|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.98|1.62|0.0041
71749337|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6121|TWO_SIDED|95.0|0.28|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.13|0.28|0.6121
71781218|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|1.87||||0.0062|TWO_SIDED|95.0|0.493|3.25||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||3.250|0.493|0.0062
71781219|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|1.19||||0.149|TWO_SIDED|95.0|-0.327|2.717||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.717|-0.327|0.1490
71781220|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|0.63||||0.6285|TWO_SIDED|95.0|-0.931|2.2||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 24 Hours, Day 2||2.200|-0.931|0.6285
71668067|NCT03718832|142852677|SUPERIORITY||Mean Difference (Net)|0.0179852|STANDARD_ERROR_OF_MEAN|0.0171811||0.2961479|TWO_SIDED|95.0|-0.0158442|0.0518147||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0518147|-0.0158442|0.2961479
71749338|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2329|TWO_SIDED|95.0|0.68|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.75|0.68|0.2329
71749339|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0891|TWO_SIDED|95.0|0.88|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.90|0.88|0.0891
71749340|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.55||||0.6857|TWO_SIDED|95.0|0.03|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.97|0.03|0.6857
71749341|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.56||||0.7291|TWO_SIDED|95.0|0.12|19.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.71|0.12|0.7291
71749342|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8951|TWO_SIDED|95.0|0.05|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.41|0.05|0.8951
71749343|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.66||||0.6865|TWO_SIDED|95.0|0.14|19.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.74|0.14|0.6865
71749344|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9132|TWO_SIDED|95.0|0.07|20.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.24|0.07|0.9132
71749345|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.38||||0.7982|TWO_SIDED|95.0|0.12|16.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.59|0.12|0.7982
71749346|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|1.17||||0.9029|TWO_SIDED|95.0|0.09|15.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||15.57|0.09|0.9029
71749347|NCT03192176|143005303|SUPERIORITY||Odds Ratio (OR)|0.69||||0.7971|TWO_SIDED|95.0|0.04|11.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.94|0.04|0.7971
71749348|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|0.67||||0.7899|TWO_SIDED|95.0|0.04|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.34|0.04|0.7899
71749349|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|0.86||||0.9186|TWO_SIDED|95.0|0.05|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.73|0.05|0.9186
71749350|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.19||||0.5303|TWO_SIDED|95.0|0.19|25.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||25.46|0.19|0.5303
71749351|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|5.85||||0.1149|TWO_SIDED|95.0|0.65|52.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||52.66|0.65|0.1149
71749352|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|9.07||||0.0442|TWO_SIDED|95.0|1.06|77.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||77.71|1.06|0.0442
71749353|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2851|TWO_SIDED|95.0|0.35|35.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||35.68|0.35|0.2851
71749354|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.22||||0.2073|TWO_SIDED|95.0|0.45|39.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||39.48|0.45|0.2073
71749355|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.68||||0.27|TWO_SIDED|95.0|0.36|37.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||37.16|0.36|0.2700
71749356|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.41||||0.2982|TWO_SIDED|95.0|0.34|34.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||34.27|0.34|0.2982
71749357|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|12.3||||0.0204|TWO_SIDED|95.0|1.47|102.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||102.6|1.47|0.0204
71749358|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|11.1||||0.027|TWO_SIDED|95.0|1.31|93.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||93.74|1.31|0.0270
71749359|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.22||||0.5224|TWO_SIDED|95.0|0.19|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.68|0.19|0.5224
71749360|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1635|TWO_SIDED|95.0|0.52|46.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||46.35|0.52|0.1635
71749361|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|10.97||||0.0266|TWO_SIDED|95.0|1.32|91.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||91.15|1.32|0.0266
71749362|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.69||||0.4299|TWO_SIDED|95.0|0.23|31.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||31.21|0.23|0.4299
71749363|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.87||||0.1667|TWO_SIDED|95.0|0.52|45.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||45.84|0.52|0.1667
71781221|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|1.29||||0.0358|TWO_SIDED|95.0|0.073|2.501||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.501|0.073|0.0358
71781222|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|1.33||||0.043|TWO_SIDED|95.0|0.035|2.621||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||2.621|0.035|0.0430
71781223|NCT03281577|143062119|SUPERIORITY||Least Squares Mean Differences|0.25||||0.9419|TWO_SIDED|95.0|-1.107|1.611||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|Colonic Transit at 48 Hours, Day 2||1.611|-1.107|0.9419
71749364|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|8.11||||0.0592|TWO_SIDED|95.0|0.92|71.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.35|0.92|0.0592
71749365|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|18.28||||0.007|TWO_SIDED|95.0|2.21|151.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||151.2|2.21|0.0070
71749366|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.79||||0.2594|TWO_SIDED|95.0|0.37|38.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||38.32|0.37|0.2594
71749367|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|8.14||||0.0589|TWO_SIDED|95.0|0.92|71.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||71.67|0.92|0.0589
71749368|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0338|TWO_SIDED|95.0|1.19|85.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||85.20|1.19|0.0338
71749369|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7756|TWO_SIDED|95.0|0.12|4.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.88|0.12|0.7756
71749370|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9246|TWO_SIDED|95.0|0.2|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.74|0.20|0.9246
71749371|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0177|TWO_SIDED|95.0|1.34|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.93|1.34|0.0177
71749372|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|5.38||||0.0178|TWO_SIDED|95.0|1.34|21.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||21.65|1.34|0.0178
71749373|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.17||||0.8564|TWO_SIDED|95.0|0.22|6.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.20|0.22|0.8564
71749374|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.52||||0.2202|TWO_SIDED|95.0|0.58|11.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.00|0.58|0.2202
71749375|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.37||||0.2498|TWO_SIDED|95.0|0.55|10.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.25|0.55|0.2498
71749376|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0576|TWO_SIDED|95.0|0.93|72.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.29|0.93|0.0576
71749377|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.34||||0.3065|TWO_SIDED|95.0|0.33|33.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.59|0.33|0.3065
71749378|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|19.9||||0.0056|TWO_SIDED|95.0|2.4|165.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||165.1|2.40|0.0056
71749379|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|25.05||||0.0027|TWO_SIDED|95.0|3.05|205.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||205.5|3.05|0.0027
71781224|NCT03281577|143062120|SUPERIORITY||Least Squares Mean Differences|33.12||||0.0436|TWO_SIDED|95.0|0.799|65.439||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||65.439|0.799|0.0436
71749380|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.61||||0.2762|TWO_SIDED|95.0|0.36|36.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||36.51|0.36|0.2762
71749381|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|6.93||||0.0851|TWO_SIDED|95.0|0.77|62.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||62.69|0.77|0.0851
71749382|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|17.02||||0.0081|TWO_SIDED|95.0|2.09|138.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||138.7|2.09|0.0081
71749383|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|6.37||||0.0995|TWO_SIDED|95.0|0.7|57.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||57.62|0.70|0.0995
71749384|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|5.76||||0.1184|TWO_SIDED|95.0|0.64|51.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||51.80|0.64|0.1184
71749385|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|26.54||||0.0023|TWO_SIDED|95.0|3.23|218.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||218.3|3.23|0.0023
71749386|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|19.09||||0.0062|TWO_SIDED|95.0|2.31|157.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||157.9|2.31|0.0062
71749387|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|7.49||||0.0695|TWO_SIDED|95.0|0.85|65.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||65.87|0.85|0.0695
71749388|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|8.64||||0.052|TWO_SIDED|95.0|0.98|75.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||75.98|0.98|0.0520
71749389|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|22.3||||0.0036|TWO_SIDED|95.0|2.75|180.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||180.6|2.75|0.0036
71668068|NCT03718832|142852678|SUPERIORITY||Mean Difference (Net)|0.4018522|STANDARD_ERROR_OF_MEAN|0.1001575||7.43e-05|TWO_SIDED|95.0|0.2048311|0.5988733||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.5988733|0.2048311|0.0000743
71749390|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0676|TWO_SIDED|95.0|0.89|24.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||24.23|0.89|0.0676
71749391|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.14||||0.0903|TWO_SIDED|95.0|0.8|21.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.38|0.80|0.0903
71749392|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|15.46||||0.0007|TWO_SIDED|95.0|3.18|75.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||75.14|3.18|0.0007
71749393|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|10.94||||0.0032|TWO_SIDED|95.0|2.22|53.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.77|2.22|0.0032
71749394|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.04||||0.2031|TWO_SIDED|95.0|0.55|16.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||16.85|0.55|0.2031
71781225|NCT03281577|143062120|SUPERIORITY||Least Squares Mean Differences|57.98||||0.0007|TWO_SIDED|95.0|23.555|92.396||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||92.396|23.555|0.0007
71781226|NCT03281577|143062120|SUPERIORITY||Least Squares Mean Differences|44.44||||0.0134|TWO_SIDED|95.0|8.249|80.629||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||80.629|8.249|0.0134
71781227|NCT03281577|143062121|SUPERIORITY||Least Squares Mean Differences|-10.27||||0.0789|TWO_SIDED|95.0|-21.507|0.96||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.960|-21.507|0.0789
71749395|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.13||||0.0972|TWO_SIDED|95.0|0.77|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||22.10|0.77|0.0972
71749396|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|11.04||||0.0027|TWO_SIDED|95.0|2.3|53.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.06|2.30|0.0027
71749397|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.06||||0.1306|TWO_SIDED|95.0|0.72|13.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.02|0.72|0.1306
71749398|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0248|TWO_SIDED|95.0|1.22|19.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.10|1.22|0.0248
71781228|NCT03281577|143062121|SUPERIORITY||Least Squares Mean Differences|-13.28||||0.027|TWO_SIDED|95.0|-25.242|-1.314||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||-1.314|-25.242|0.0270
71781229|NCT03281577|143062121|SUPERIORITY||Least Squares Mean Differences|-11.63||||0.075|TWO_SIDED|95.0|-24.206|0.952||Dunnett's test was used to compare each treatment arm to placebo. Multiplicity Adjusted p-value and 95% CI are presented.|ANCOVA||Linear mixed effects model used for analyses using gastroparesis type \[diabetic or idiopathic\], age, gender, BMI, baseline as a covariate.|||0.952|-24.206|0.0750
71668069|NCT03718832|142852678|SUPERIORITY||Mean Difference (Net)|0.3643095|STANDARD_ERROR_OF_MEAN|0.1026922||0.0004471|TWO_SIDED|95.0|0.16227|0.566349||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.566349|0.16227|0.0004471
71668070|NCT03718832|142852678|SUPERIORITY||Mean Difference (Net)|0.0006229|STANDARD_ERROR_OF_MEAN|0.1095781||0.9954683|TWO_SIDED|95.0|-0.2150785|0.2163243||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2163243|-0.2150785|0.9954683
71668071|NCT03718832|142852678|SUPERIORITY||Mean Difference (Net)|-0.0161147|STANDARD_ERROR_OF_MEAN|0.1115322||0.8852268|TWO_SIDED|95.0|-0.2357129|0.2034834||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2034834|-0.2357129|0.8852268
71668072|NCT03718832|142852679|SUPERIORITY||Mean Difference (Net)|0.9013876|STANDARD_ERROR_OF_MEAN|0.4414753||0.0417413|TWO_SIDED|95.0|0.0338441|1.768931||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1.768931|0.0338441|0.0417413
71668073|NCT03718832|142852679|SUPERIORITY||Mean Difference (Net)|0.8939751|STANDARD_ERROR_OF_MEAN|0.3896126||0.0222222|TWO_SIDED|95.0|0.1282798|1.65967||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1.65967|0.1282798|0.0222222
71668074|NCT03718832|142852679|SUPERIORITY||Mean Difference (Net)|0.0276596|STANDARD_ERROR_OF_MEAN|0.7606961||0.9710103|TWO_SIDED|95.0|-1.467185|1.522504||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1.522504|-1.467185|0.9710103
71749399|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|7.14||||0.0054|TWO_SIDED|95.0|1.79|28.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||28.53|1.79|0.0054
71835295|NCT03897686|143175374|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~2\) Group A (NOLTREX™) OA grade II versus Group A (NOLTREX™) ОА grade III"||123.82|-197.83|0.9324
71891525|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.053|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.152|0.053|<0.0001
71749400|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|10.01||||0.001|TWO_SIDED|95.0|2.55|39.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||39.36|2.55|0.0010
71749401|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.21||||0.8271|TWO_SIDED|95.0|0.23|6.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.45|0.23|0.8271
71668075|NCT03718832|142852679|SUPERIORITY||Mean Difference (Net)|0.0377244|STANDARD_ERROR_OF_MEAN|0.6523585||0.9539117|TWO_SIDED|95.0|-1.244338|1.319787||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1.319787|-1.244338|0.9539117
71668076|NCT03718832|142852680|SUPERIORITY||Mean Difference (Net)|-0.1045328|STANDARD_ERROR_OF_MEAN|0.1417549||0.4612408|TWO_SIDED|95.0|-0.3830955|0.1740299||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1740299|-0.3830955|0.4612408
71668077|NCT03718832|142852680|SUPERIORITY||Mean Difference (Net)|-0.0552724|STANDARD_ERROR_OF_MEAN|0.1181649||0.6401864|TWO_SIDED|95.0|-0.2874987|0.176954||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.176954|-0.2874987|0.6401864
71668078|NCT03718832|142852680|SUPERIORITY||Mean Difference (Net)|-0.2761332|STANDARD_ERROR_OF_MEAN|0.2593125||0.2874913|TWO_SIDED|95.0|-0.7857084|0.2334419||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.2334419|-0.7857084|0.2874913
71749402|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.27||||0.1089|TWO_SIDED|95.0|0.77|13.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.95|0.77|0.1089
71749403|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|5.58||||0.0138|TWO_SIDED|95.0|1.42|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||21.93|1.42|0.0138
71668079|NCT03718832|142852680|SUPERIORITY||Mean Difference (Net)|-0.155843|STANDARD_ERROR_OF_MEAN|0.2092772||0.4568601|TWO_SIDED|95.0|-0.56713|0.2554439||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.2554439|-0.56713|0.4568601
71668080|NCT03718832|142852681|SUPERIORITY||Mean Difference (Net)|0.0539315|STANDARD_ERROR_OF_MEAN|0.0267347||0.0442418|TWO_SIDED|95.0|0.0013953|0.1064678||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.1064678|0.0013953|0.0442418
71668081|NCT03718832|142852681|SUPERIORITY||Mean Difference (Net)|0.0546574|STANDARD_ERROR_OF_MEAN|0.0272506||0.0454857|TWO_SIDED|95.0|0.0011025|0.1082124||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.1082124|0.0011025|0.0454857
71835296|NCT03897686|143175374|SUPERIORITY||LS-means difference|-216.31|STANDARD_ERROR_OF_MEAN|75.01||0.0233|TWO_SIDED|95.0|-411.37|-21.25||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~3\) Group A (NOLTREX™) OA grade II versus Group B (Placebo) ОА grade III"||-21.25|-411.37|0.0233
71835297|NCT03897686|143175374|SUPERIORITY||LS-means difference|142.3|STANDARD_ERROR_OF_MEAN|81.89||0.3082|TWO_SIDED|95.0|-70.63|355.22||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~4\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade II"||355.22|-70.63|0.3082
71749404|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1987|TWO_SIDED|95.0|0.63|9.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.15|0.63|0.1987
71749405|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3984|TWO_SIDED|95.0|0.46|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.02|0.46|0.3984
71749406|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0402|TWO_SIDED|95.0|1.06|14.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||14.45|1.06|0.0402
71749407|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|8.05||||0.001|TWO_SIDED|95.0|2.32|27.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||27.95|2.32|0.0010
71749408|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8287|TWO_SIDED|95.0|0.17|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.08|0.17|0.8287
71749409|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.93||||0.1083|TWO_SIDED|95.0|0.79|10.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.92|0.79|0.1083
71668082|NCT03718832|142852681|SUPERIORITY||Mean Difference (Net)|0.0076781|STANDARD_ERROR_OF_MEAN|0.0188378||0.683764|TWO_SIDED|95.0|-0.0293401|0.0446963||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0446963|-0.0293401|0.683764
71668083|NCT03718832|142852681|SUPERIORITY||Mean Difference (Net)|0.0053342|STANDARD_ERROR_OF_MEAN|0.0183059||0.7708852|TWO_SIDED|95.0|-0.0306419|0.0413103||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0413103|-0.0306419|0.7708852
71749410|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0043|TWO_SIDED|95.0|1.76|20.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.66|1.76|0.0043
71749411|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.23||||0.1126|TWO_SIDED|95.0|0.76|13.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.79|0.76|0.1126
71749412|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.9||||0.1479|TWO_SIDED|95.0|0.69|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.30|0.69|0.1479
71749413|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|10.49||||0.001|TWO_SIDED|95.0|2.59|42.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.46|2.59|0.0010
71835298|NCT03897686|143175374|SUPERIORITY||LS-means difference|-37.01|STANDARD_ERROR_OF_MEAN|61.85||0.9324|TWO_SIDED|95.0|-197.83|123.82||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~5\) versus Group B (Placebo) OA grade II versus Group B (Placebo) ОА grade III"||123.82|-197.83|0.9324
71835299|NCT03897686|143175374|SUPERIORITY||Slope|-179.3|STANDARD_ERROR_OF_MEAN|48.38||0.0017|TWO_SIDED|95.0|-305.11|-53.5||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||"After the analysis of covariance were performed pairwise comparisons of NOLTREX and placebo groups for each stage of OA:~6\) Group A (NOLTREX™) OA grade III versus Group B (Placebo) ОА grade III"||-53.50|-305.11|0.0017
71749414|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|13.01||||0.0002|TWO_SIDED|95.0|3.31|51.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.14|3.31|0.0002
71749415|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1483|TWO_SIDED|95.0|0.68|12.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.41|0.68|0.1483
71749416|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|4.03||||0.0557|TWO_SIDED|95.0|0.97|16.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||16.84|0.97|0.0557
71749417|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|6.47||||0.0072|TWO_SIDED|95.0|1.66|25.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.28|1.66|0.0072
71749418|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9715|TWO_SIDED|95.0|0.32|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.24|0.32|0.9715
71749419|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.49||||0.472|TWO_SIDED|95.0|0.5|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.39|0.50|0.4720
71749420|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1262|TWO_SIDED|95.0|0.79|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.05|0.79|0.1262
71749421|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0396|TWO_SIDED|95.0|1.05|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.92|1.05|0.0396
71749422|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5137|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.29|0.19|0.5137
71749423|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|2.25||||0.137|TWO_SIDED|95.0|0.77|6.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.58|0.77|0.1370
71749424|NCT03192176|143005304|SUPERIORITY||Odds Ratio (OR)|1.39||||0.5526|TWO_SIDED|95.0|0.47|4.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.07|0.47|0.5526
71749425|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0012|TWO_SIDED|95.0|1.99|16.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.62|1.99|0.0012
71668084|NCT03718832|142852682|SUPERIORITY||Mean Difference (Net)|-0.053099|STANDARD_ERROR_OF_MEAN|0.0436586||0.2245167|TWO_SIDED|95.0|-0.1388926|0.0326946||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0326946|-0.1388926|0.2245167
71749426|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.0001|TWO_SIDED|95.0|3.06|25.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.68|3.06|<0.0001
71835300|NCT03897686|143175375|SUPERIORITY|\[Not specified\]|S-means difference|-143.39|STANDARD_ERROR_OF_MEAN|46.88||0.00267|TWO_SIDED|95.0|-236.09|-50.69||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||It was determined that 144 participants randomized into 2 groups (1:1) would have at least 80% power to detect an effect size of 0.25. Sample size was calculated based on analysis of covariance adjusted for baseline value with fixed factors of group assuming α = 0.05 and 10% discontinuation rate.||-50.69|-236.09|0.00267
71781230|NCT01663532|143062126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0005|TWO_SIDED|95.0|-6.1|-1.7||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-1.7|-6.1|0.0005
71781231|NCT01663532|143062126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.0||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-4.0|-10.0|<.0001
71781232|NCT01663532|143062126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.8|-5.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-5.6|-12.8|<.0001
71781233|NCT01663532|143062126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-15.0|-7.3||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-7.3|-15.0|<.0001
71813060|NCT05674890|143128458|EQUIVALENCE|"Any deviation greater that +/- 0.60 (Effect size/Stdev OR 0.15/0.25=0.60) between device means was considered non-equivalent."|Mean Difference (Net)|-48.75|STANDARD_DEVIATION|56.48|<|0.001|TWO_SIDED||||||t-test, 2 sided|||Prior to patient enrollment, a power calculation was conducted to assess the ability of our analyses to reliably detect differences between the HFA and SSVR. With a sample size of 80, assumed effect size of 0.15, standard deviation of 0.25, intraclass correlation coefficient of 0.50, and significance level of 0.05, our analysis reaches a power of 0.87.||||<0.001
71813061|NCT00520975|143128466|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Cox|||||1.23|0.43|0.24
71813062|NCT00520975|143128467|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.75|TWO_SIDED|95.0|0.61|1.97|||Regression, Cox|||||1.97|0.61|0.75
71668085|NCT03718832|142852682|SUPERIORITY||Mean Difference (Net)|-0.0815933|STANDARD_ERROR_OF_MEAN|0.0424438||0.0551913|TWO_SIDED|95.0|-0.1650069|0.0018204||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||0.0018204|-0.1650069|0.0551913
71749427|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|11.55|||<|0.0001|TWO_SIDED|95.0|3.94|33.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.85|3.94|<0.0001
71749428|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|13.55|||<|0.0001|TWO_SIDED|95.0|4.55|40.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||40.38|4.55|<0.0001
71749429|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0555|TWO_SIDED|95.0|0.98|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.61|0.98|0.0555
71749430|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|7.98||||0.0001|TWO_SIDED|95.0|2.75|23.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.18|2.75|0.0001
71749431|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0001|TWO_SIDED|95.0|2.81|23.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.19|2.81|0.0001
71668086|NCT03718832|142852682|SUPERIORITY||Mean Difference (Net)|-0.0506938|STANDARD_ERROR_OF_MEAN|0.0461078||0.2721373|TWO_SIDED|95.0|-0.1413002|0.0399126||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||0.0399126|-0.1413002|0.2721373
71668087|NCT03718832|142852682|SUPERIORITY||Mean Difference (Net)|-0.079563|STANDARD_ERROR_OF_MEAN|0.0428514||0.0640071|TWO_SIDED|95.0|-0.1637776|0.0046516||Adjusted mean difference for full controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||0.0046516|-0.1637776|0.0640071
71749432|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.55||||0.0012|TWO_SIDED|95.0|1.82|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.39|1.82|0.0012
71749433|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.25||||0.0005|TWO_SIDED|95.0|2.06|13.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.43|2.06|0.0005
71749434|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0003|TWO_SIDED|95.0|2.2|14.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.39|2.20|0.0003
71749435|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|8.42|||<|0.0001|TWO_SIDED|95.0|2.99|23.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.74|2.99|<0.0001
71749436|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0277|TWO_SIDED|95.0|1.12|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.12|0.0277
71749437|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0022|TWO_SIDED|95.0|1.66|10.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.32|1.66|0.0022
71749438|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0314|TWO_SIDED|95.0|1.26|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.41|1.26|0.0314
71749439|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0041|TWO_SIDED|95.0|1.54|9.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.97|1.54|0.0041
71749440|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.19||||0.0028|TWO_SIDED|95.0|1.64|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.74|1.64|0.0028
71749441|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0011|TWO_SIDED|95.0|1.9|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.98|1.90|0.0011
71813063|NCT04810221|143128477|OTHER|Paired T-test 0|Mean Difference (Final Values)|0.18||||0.31|TWO_SIDED|95.0|-0.17|0.54|||Paired T-test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.54|-0.17|0.31
71668088|NCT03718832|142852683|SUPERIORITY||Mean Difference (Net)|13.79692|STANDARD_ERROR_OF_MEAN|808.862||0.9864081|TWO_SIDED|95.0|-1581.244|1608.838||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||1608.838|-1581.244|0.9864081
71668089|NCT03718832|142852683|SUPERIORITY||Mean Difference (Net)|119.3302|STANDARD_ERROR_OF_MEAN|885.2058||0.8929133|TWO_SIDED|95.0|-1627.128|1865.789||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||1865.789|-1627.128|0.8929133
71749442|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|8.79||||0.0001|TWO_SIDED|95.0|2.86|26.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||26.99|2.86|0.0001
71813064|NCT04810221|143128478|OTHER|Paired T test 0|Mean Difference (Final Values)|0.25||||0.32|TWO_SIDED|95.0|-0.24|0.75|||Paired T test 0||||Additional statistical analysis were: Bland Altman plot and linear regression analysis.|0.75|-0.24|0.32
71813065|NCT05383417|143128491|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||||||0.03
71813066|NCT05383417|143128492|SUPERIORITY|||||||0.18|||||||t-test, 1 sided|||||||0.18
71749443|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0036|TWO_SIDED|95.0|1.59|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.57|1.59|0.0036
71749444|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.52||||0.0018|TWO_SIDED|95.0|1.75|11.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.67|1.75|0.0018
71749445|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0243|TWO_SIDED|95.0|1.14|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.68|1.14|0.0243
71781234|NCT01663532|143062126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-18.4|-9.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-9.6|-18.4|<.0001
71781235|NCT01663532|143062126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.4|-10.8||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.||-10.8|-19.4|<.0001
71781236|NCT01663532|143062127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0001|TWO_SIDED|95.0|-0.4|-0.1||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.1|-0.4|0.0001
71781237|NCT01663532|143062127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.2|-0.6|<.0001
71749446|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.33||||0.077|TWO_SIDED|95.0|0.91|5.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.96|0.91|0.0770
71749447|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.61||||0.0451|TWO_SIDED|95.0|1.02|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.69|1.02|0.0451
71749448|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0165|TWO_SIDED|95.0|1.25|9.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.04|1.25|0.0165
71749449|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0037|TWO_SIDED|95.0|1.72|16.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||16.23|1.72|0.0037
71781238|NCT01663532|143062127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-0.7|<.0001
71813067|NCT05383417|143128493|SUPERIORITY|||||||0.007|||||||t-test, 1 sided|Day 2||||||0.007
71813068|NCT05383417|143128493|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
71813069|NCT05383417|143128494|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|Day 1||||||0.03
71813070|NCT05383417|143128494|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 7||||||0.04
71813071|NCT05383417|143128495|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|Day 1||||||0.04
71749450|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0812|TWO_SIDED|95.0|0.9|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.90|0.0812
71668090|NCT03718832|142852683|SUPERIORITY||Mean Difference (Net)|-1260.452|STANDARD_ERROR_OF_MEAN|1327.743||0.343724|TWO_SIDED|95.0|-3880.298|1359.393||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||1359.393|-3880.298|0.343724
71891526|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.025||0.0116|TWO_SIDED|95.0|0.014|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.113|0.014|0.0116
71668091|NCT03718832|142852683|SUPERIORITY||Mean Difference (Net)|-1206.216|STANDARD_ERROR_OF_MEAN|1344.574||0.3709654|TWO_SIDED|95.0|-3860.887|1448.455||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||1448.455|-3860.887|0.3709654
71668092|NCT03718832|142852684|SUPERIORITY||Mean Difference (Net)|1290.605|STANDARD_ERROR_OF_MEAN|732.2306||0.0795087|TWO_SIDED|95.0|-153.3215|2734.532||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2734.532|-153.3215|0.0795087
71749451|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.46||||0.0577|TWO_SIDED|95.0|0.97|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.22|0.97|0.0577
71749452|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0706|TWO_SIDED|95.0|0.93|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.85|0.93|0.0706
71749453|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0404|TWO_SIDED|95.0|1.04|7.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.00|1.04|0.0404
71749454|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0054|TWO_SIDED|95.0|1.54|11.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.99|1.54|0.0054
71749455|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0186|TWO_SIDED|95.0|1.22|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.27|1.22|0.0186
71749456|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|6.58||||0.0023|TWO_SIDED|95.0|1.96|22.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||22.14|1.96|0.0023
71749457|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0118|TWO_SIDED|95.0|1.33|9.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.93|1.33|0.0118
71749458|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.57||||0.002|TWO_SIDED|95.0|1.88|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.53|1.88|0.0020
71749459|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.71||||0.043|TWO_SIDED|95.0|1.03|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.14|1.03|0.0430
71749460|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2197|TWO_SIDED|95.0|0.7|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.66|0.70|0.2197
71749461|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1341|TWO_SIDED|95.0|0.8|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.42|0.80|0.1341
71749462|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0196|TWO_SIDED|95.0|1.23|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.05|1.23|0.0196
71749463|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0121|TWO_SIDED|95.0|1.41|16.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.26|1.41|0.0121
71749464|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1511|TWO_SIDED|95.0|0.77|5.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.56|0.77|0.1511
71781239|NCT01663532|143062127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
71781240|NCT01663532|143062127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.5|-0.9|<.0001
71781241|NCT01663532|143062127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-1.1|<.0001
71781242|NCT01663532|143062128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.0006|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.6|-2.1|0.0006
71781243|NCT01663532|143062128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.3|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.3|<.0001
71781244|NCT01663532|143062128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.0|-4.3|<.0001
71781245|NCT01663532|143062128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.1|-2.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-2.6|-5.1|<.0001
71781246|NCT01663532|143062128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|||<|0.0001|TWO_SIDED|95.0|-6.2|-3.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.4|-6.2|<.0001
71781247|NCT01663532|143062128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.7|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-3.7|-6.4|<.0001
71781248|NCT01663532|143062129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.0023|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.3|-1.6|0.0023
71781249|NCT01663532|143062129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.0032|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.4|-2.0|0.0032
71813072|NCT05383417|143128496|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|Day2||||||0.02
71813073|NCT05383417|143128497|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71813074|NCT05383417|143128498|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
71813075|NCT05383417|143128499|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71668093|NCT03718832|142852684|SUPERIORITY||Mean Difference (Net)|1207.762|STANDARD_ERROR_OF_MEAN|874.6068||0.1689786|TWO_SIDED|95.0|-517.7854|2933.309||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2933.309|-517.7854|0.1689786
71668094|NCT03718832|142852684|SUPERIORITY||Mean Difference (Net)|1209.35|STANDARD_ERROR_OF_MEAN|957.1006||0.2080145|TWO_SIDED|95.0|-679.1596|3097.86||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment||3097.86|-679.1596|0.2080145
71668095|NCT03718832|142852684|SUPERIORITY||Mean Difference (Net)|1258.587|STANDARD_ERROR_OF_MEAN|1077.807||0.2445904|TWO_SIDED|95.0|-869.3893|3386.563||Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment||3386.563|-869.3893|0.2445904
71668096|NCT03718832|142852685|SUPERIORITY||Mean Difference (Net)|2.035245|STANDARD_ERROR_OF_MEAN|0.1415551|<|0.001|TWO_SIDED|95.0|1.757075|2.313415||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||2.313415|1.757075|<0.001
71668097|NCT03718832|142852685|SUPERIORITY||Mean Difference (Net)|2.0087|STANDARD_ERROR_OF_MEAN|0.1395364|<|0.001|TWO_SIDED|95.0|1.734473|2.282927||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment||2.282927|1.734473|<0.001
71668098|NCT03718832|142852685|SUPERIORITY||Mean Difference (Net)|1.619982|STANDARD_ERROR_OF_MEAN|0.2663507|<|0.001|TWO_SIDED|95.0|1.096575|2.143388||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.143388|1.096575|<0.001
71668099|NCT03718832|142852685|SUPERIORITY||Mean Difference (Net)|1.559642|STANDARD_ERROR_OF_MEAN|0.2680774|<|0.001|TWO_SIDED|95.0|1.032797|2.086488||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.086488|1.032797|<0.001
71668100|NCT03718832|142852686|SUPERIORITY||Mean Difference (Net)|1.881776|STANDARD_ERROR_OF_MEAN|0.1057965|<|0.001|TWO_SIDED|95.0|1.673875|2.089677||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||2.089677|1.673875|<0.001
71668101|NCT03718832|142852686|SUPERIORITY||Mean Difference (Net)|1.868221|STANDARD_ERROR_OF_MEAN|0.1036609|<|0.001|TWO_SIDED|95.0|1.664499|2.071943||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||2.071943|1.664499|<0.001
71749465|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.94||||0.0068|TWO_SIDED|95.0|1.55|15.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.68|1.55|0.0068
71749466|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0741|TWO_SIDED|95.0|0.91|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.79|0.91|0.0741
71668102|NCT03718832|142852686|SUPERIORITY||Mean Difference (Net)|1.650879|STANDARD_ERROR_OF_MEAN|0.2057239|<|0.001|TWO_SIDED|95.0|1.246611|2.055147||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||2.055147|1.246611|<0.001
71668103|NCT03718832|142852686|SUPERIORITY||Mean Difference (Net)|1.636306|STANDARD_ERROR_OF_MEAN|0.2052192|<|0.001|TWO_SIDED|95.0|1.232994|2.039618||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||2.039618|1.232994|<0.001
71668104|NCT03718832|142852687|SUPERIORITY||Mean Difference (Net)|0.1104533|STANDARD_ERROR_OF_MEAN|0.0769621||0.1519153|TWO_SIDED|95.0|-0.040785|0.2616915||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment.||0.2616915|-0.040785|0.1519153
71668105|NCT03718832|142852687|SUPERIORITY||Mean Difference (Net)|0.0594575|STANDARD_ERROR_OF_MEAN|0.0654489||0.3641254|TWO_SIDED|95.0|-0.0691675|0.1880824||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.1880824|-0.0691675|0.3641254
71668106|NCT03718832|142852687|SUPERIORITY||Mean Difference (Net)|0.2062905|STANDARD_ERROR_OF_MEAN|0.1288363||0.1100186|TWO_SIDED|95.0|-0.0468859|0.4594669||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||0.4594669|-0.0468859|0.1100186
71813076|NCT05383417|143128500|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71668107|NCT03718832|142852687|SUPERIORITY||Mean Difference (Net)|0.1162375|STANDARD_ERROR_OF_MEAN|0.1015839||0.2531303|TWO_SIDED|95.0|-0.0834025|0.3158775||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||0.3158775|-0.0834025|0.2531303
71668108|NCT03718832|142852688|SUPERIORITY||Mean Difference (Net)|-0.0584644|STANDARD_ERROR_OF_MEAN|0.040837||0.152918|TWO_SIDED|95.0|-0.1387132|0.0217844||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 6 months after trial enrollment||0.0217844|-0.1387132|0.152918
71813077|NCT05383417|143128501|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71813078|NCT05383417|143128502|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71668109|NCT03718832|142852688|SUPERIORITY||Mean Difference (Net)|-0.0585771|STANDARD_ERROR_OF_MEAN|0.0304262||0.0548344|TWO_SIDED|95.0|-0.1183728|0.0012186||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 6 months after trial enrollment.||0.0012186|-0.1183728|0.0548344
71668110|NCT03718832|142852688|SUPERIORITY||Mean Difference (Net)|-0.1691027|STANDARD_ERROR_OF_MEAN|0.0673022||0.0123238|TWO_SIDED|95.0|-0.3013583|-0.036847||Unadjusted mean difference; threshold for statistical significance: 0.05. Heteroskedasticity-robust standard errors.|t-test, 2 sided|||Unadjusted mean difference, 12 months after trial enrollment.||-0.036847|-0.3013583|0.0123238
71668111|NCT03718832|142852688|SUPERIORITY||Mean Difference (Net)|-0.1701425|STANDARD_ERROR_OF_MEAN|0.0575065||0.0032534|TWO_SIDED|95.0|-0.2831584|-0.0571266||"Adjusted mean difference for full prespecified controls; threshold for statistical significance: 0.05.~Heteroskedasticity-robust standard errors."|Regression, Linear|||Adjusted mean difference for full controls, 12 months after trial enrollment.||-0.0571266|-0.2831584|0.0032534
71668112|NCT03503669|142852705|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71668113|NCT03503669|142852706|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
71668114|NCT03503669|142852707|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71668115|NCT03503669|142852708|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71668116|NCT03503669|142852709|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71668117|NCT03288714|142852725|SUPERIORITY|||||||0.814|||||||Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.814
71668118|NCT03288714|142852726|SUPERIORITY|||||||0.872|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||Null hypothesis is that the active sTMS treatment group does not differ from the sham group with respect to the proportion of patients with clinical response at Week 6.||||.872
71668119|NCT03288714|142852727|SUPERIORITY|||||||0.641|||||||ANCOVA|P-value is from analysis of covariance adjusting for baseline.||The null hypothesis is that the active sTMS treatment group does not differ||||.641
71668120|NCT03288714|142852728|SUPERIORITY|||||||0.032||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.032
71749467|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2772|TWO_SIDED|95.0|0.65|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.43|0.65|0.2772
71749468|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0705|TWO_SIDED|95.0|0.92|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|0.92|0.0705
71813079|NCT01226511|143128503|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-2.65|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.03|-1.27|||Mixed Models Analysis|||||-1.27|-4.03|<0.001
71668121|NCT03288714|142852729|SUPERIORITY|||||||0.015||||||Alpha level: .05|ANCOVA|P-value is from analysis of covariance adjusting for baseline||||||.015
71668122|NCT03288714|142852730|SUPERIORITY|||||||0.028||||||Alpha level: .05|Fisher Exact|The proportion of patients is compared across treatment groups using Fisher's Exact.||||||.028
71813080|NCT01337986|143128518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Mixed Models Analysis|||Per protocol Analysis||||0.84
71668123|NCT02203357|142852735|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.|ANOVA|||||||<0.05
71668124|NCT01870778|142852790|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3857|TWO_SIDED|95.0|0.83|1.15||Adjusted alpha p-value based on multiple testing procedure.|Log Rank|One-sided p-value||||1.15|0.83|0.3857
71668125|NCT01870778|142852791|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0968|TWO_SIDED|95.0|0.75|1.07||Adjusted p-value based on multiple testing procedure|Gehan's generalized Wilcoxon test|One-sided p-value||||1.07|0.75|0.0968
71668126|NCT01870778|142852792|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.389|TWO_SIDED|95.0|0.81|1.08|||Log Rank|2-sided p-value||||1.08|0.81|0.3890
71668127|NCT01870778|142852793|SUPERIORITY|||||||0.2204||||||Based on multiple testing procedure|Wilcoxon rank sum test|One-sided p-value||||||0.2204
71668128|NCT01870778|142852794|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.2744|TWO_SIDED|95.0|0.88|1.07||Adjusted p-value based on multiple testing procedure|Log Rank|||||1.07|0.88|0.2744
71668129|NCT01870778|142852795|SUPERIORITY|||||||0.2103|||||||Wilcoxon rank sum test|2-sided p-value||||||0.2103
71668130|NCT01870778|142852796|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.005|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Exertional dyspnea||1.14|1.02|0.0050
71668131|NCT01870778|142852796|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0051|TWO_SIDED|95.0|1.02|1.14|||Log Rank|2-sided p-value||Orthopnea||1.14|1.02|0.0051
71668132|NCT01870778|142852796|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9962|TWO_SIDED|95.0|0.95|1.05|||Log Rank|2-sided p-value||Rales||1.05|0.95|0.9962
71668133|NCT01870778|142852796|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.0196|TWO_SIDED|95.0|1.01|1.15|||Log Rank|2-sided p-value||Jugular venous pressure||1.15|1.01|0.0196
71668134|NCT01870778|142852796|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.2158|TWO_SIDED|95.0|0.98|1.1|||Log Rank|2-sided p-value||Peripheral edema, pre-sacral edema||1.10|0.98|0.2158
71668135|NCT01870778|142852797|SUPERIORITY||Ratio of RLX030 to placebo|0.9401||||0.0209|TWO_SIDED|95.0|0.8921|0.9907|||Repeated measures model|||Day 2||0.9907|0.8921|0.0209
71668136|NCT01870778|142852797|SUPERIORITY||Ratio of RLX030 to placebo|0.898||||0.0034|TWO_SIDED|95.0|0.8358|0.9649|||Repeated measures model|||Day 5||0.9649|0.8358|0.0034
71668137|NCT01870778|142852797|SUPERIORITY||Ratio of RLX030 to placebo|0.9074||||0.0209|TWO_SIDED|95.0|0.8355|0.9854|||Repeated measures model|||Day 14||0.9854|0.8355|0.0209
71668138|NCT01870778|142852798|SUPERIORITY||Ratio of RLX030 to placebo|0.8597||||0.0007|TWO_SIDED|95.0|0.7876|0.9385|||Repeated measures model|||Day 2||0.9385|0.7876|0.0007
71668139|NCT01870778|142852798|SUPERIORITY||Ratio of RLX030 to placebo|0.9539||||0.3709|TWO_SIDED|95.0|0.86|1.0579|||Repeated measures model|||Day 5||1.0579|0.8600|0.3709
71835301|NCT03897686|143175376|SUPERIORITY||LS-means difference|-13.23|STANDARD_ERROR_OF_MEAN|9.995||0.16786|TWO_SIDED|95.0|-32.096|5.638||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 3 (week 6)||5.638|-32.096|0.16786
71749469|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.88||||0.022|TWO_SIDED|95.0|1.22|12.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.39|1.22|0.0220
71749470|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.33||||0.0196|TWO_SIDED|95.0|1.27|14.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.82|1.27|0.0196
71749471|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0433|TWO_SIDED|95.0|1.03|9.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.24|1.03|0.0433
71749472|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0355|TWO_SIDED|95.0|1.08|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.20|1.08|0.0355
71749473|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3238|TWO_SIDED|95.0|0.62|4.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.28|0.62|0.3238
71749474|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.68||||0.3208|TWO_SIDED|95.0|0.6|4.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.68|0.60|0.3208
71749475|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2281|TWO_SIDED|95.0|0.67|5.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.40|0.67|0.2281
71749476|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0566|TWO_SIDED|95.0|0.97|10.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.46|0.97|0.0566
71749477|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1491|TWO_SIDED|95.0|0.73|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.73|0.1491
71749478|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1477|TWO_SIDED|95.0|0.74|7.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.23|0.74|0.1477
71749479|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0532|TWO_SIDED|95.0|0.98|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.64|0.98|0.0532
71749480|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1616|TWO_SIDED|95.0|0.73|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.76|0.73|0.1616
71781250|NCT01663532|143062129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.0003|TWO_SIDED|95.0|-2.7|-0.8|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-0.8|-2.7|0.0003
71781251|NCT01663532|143062129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.3|-3.2|<.0001
71781252|NCT01663532|143062129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.4|-3.7|<.0001
71668140|NCT01870778|142852798|SUPERIORITY||Ratio of RLX030 to placebo|0.9543||||0.3893|TWO_SIDED|95.0|0.8578|1.0617|||Repeated measures model|||Day 14||1.0617|0.8578|0.3893
71668141|NCT01870778|142852799|SUPERIORITY||Ratio of RLX030 to placebo|0.9637||||0.0003|TWO_SIDED|95.0|0.9447|0.983|||Repeated measures model|||Day 2||0.9830|0.9447|0.0003
71668142|NCT01870778|142852799|SUPERIORITY||Ratio of RLX030 to placebo|0.9922||||0.5361|TWO_SIDED|95.0|0.9677|1.0172|||Repeated measures model|||Day 5||1.0172|0.9677|0.5361
71668143|NCT01870778|142852799|SUPERIORITY||Ratio of RLX030 to placebo|0.9863||||0.375|TWO_SIDED|95.0|0.9567|1.0169|||Repeated measures model|||Day 14||1.0169|0.9567|0.3750
71668144|NCT03123068|142852812|OTHER||||||>|0.05|||||||Mann Whitney U test|||||||>0.05
71668145|NCT03180645|142852878|OTHER||Least square (LS) mean difference|-1.07||||0.0638|TWO_SIDED|95.0|-2.21|0.06|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of the face as fixed effects and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline minus the second named treatment adjusted mean change from baseline.|||0.06|-2.21|0.0638
71668146|NCT01808573|142852890|SUPERIORITY||Hazard Ratio (HR)|0.762||||0.0059|TWO_SIDED|95.0|0.626|0.926|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||0.926|0.626|0.0059
71668147|NCT01808573|142852891|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.2086|TWO_SIDED|95.0|0.723|1.073|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|||1.073|0.723|0.2086
71668148|NCT01808573|142852892|SUPERIORITY|||||||0.043|||||||Gray's test|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.||||||0.043
71668149|NCT01808573|142852893|SUPERIORITY|||||||0.1201|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.1201
71668150|NCT01808573|142852894|SUPERIORITY|||||||0.0328|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.||||||0.0328
71668151|NCT01808573|142852895|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.0004|TWO_SIDED|95.0|0.332|0.736|||Log Rank||Lapatinib Plus Capecitabine is the reference.|||0.736|0.332|0.0004
71835302|NCT03897686|143175376|SUPERIORITY||LS-means difference|-26.695|STANDARD_ERROR_OF_MEAN|9.995||0.00847|TWO_SIDED|95.0|-46.46|-6.93||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 4 (week 13)||-6.93|-46.46|0.00847
71668152|NCT03953612|142852900|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
71668153|NCT03953612|142852901|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects||||||<.001
71668154|NCT03953612|142852902|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear mixed effects||||||0.7
71668155|NCT03953612|142852903|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
71668156|NCT03953612|142852904|SUPERIORITY|||||||0.042|||||||. Negative binomial regression models|||||||0.042
71668157|NCT03953612|142852905|SUPERIORITY|||||||0.125|||||||. Negative binomial regression models|||||||0.125
71668158|NCT02028676|142852906|NON_INFERIORITY_OR_EQUIVALENCE|Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details|Hazard Ratio (HR)|1.13||||0.59|TWO_SIDED|95.0|0.73|1.73|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.73|0.73|0.59
71668159|NCT02028676|142852906|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions detailed above, \>90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).|Risk Difference (RD)|0.32||||0.43|TWO_SIDED|95.0|-0.47|1.12|||Comparison of poisson rates|Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference|Difference is CDM minus LCM|"Assumptions:~* control group (LCM) event rate 3% per year~* rates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%~* recruitment is over 1.5 years and follow-up for a minimum further 3.5 years.~* cumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough."||1.12|-0.47|0.43
71668160|NCT02028676|142852907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.83|TWO_SIDED|95.0|0.83|1.16|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.16|0.83|0.83
71668161|NCT02028676|142852908|SUPERIORITY_OR_OTHER|||||||0.33|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).||||0.33
71668162|NCT02028676|142852909|SUPERIORITY_OR_OTHER|||||||0.69|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.69
71668163|NCT02028676|142852910|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.0001
71668164|NCT02028676|142852910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.01|TWO_SIDED|95.0|1.07|1.63|||Regression, Cox||HR is Arm B vs A|||1.63|1.07|0.01
71835303|NCT03897686|143175376|SUPERIORITY||LS-means difference|-33.96|STANDARD_ERROR_OF_MEAN|10.29||0.00123|TWO_SIDED|95.0|-54.31|-13.62||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-13.62|-54.31|0.00123
71835304|NCT03897686|143175377|SUPERIORITY||LS-means difference|-0.146|STANDARD_ERROR_OF_MEAN|5.121||0.97733|TWO_SIDED|95.0|-10.271|9.98||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 3||9.980|-10.271|0.97733
71749481|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.5||||0.432|TWO_SIDED|95.0|0.55|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.11|0.55|0.4320
71749482|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2231|TWO_SIDED|95.0|0.68|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.35|0.68|0.2231
71749483|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.88||||0.0347|TWO_SIDED|95.0|1.1|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.64|1.10|0.0347
71749484|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0291|TWO_SIDED|95.0|1.17|18.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||18.07|1.17|0.0291
71749485|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2805|TWO_SIDED|95.0|0.61|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.38|0.61|0.2805
71749486|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0602|TWO_SIDED|95.0|0.95|10.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.11|0.95|0.0602
71749487|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5087|TWO_SIDED|95.0|0.51|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.88|0.51|0.5087
71749488|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1224|TWO_SIDED|95.0|0.8|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.38|0.80|0.1224
71749489|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.85||||0.228|TWO_SIDED|95.0|0.68|5.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.02|0.68|0.2280
71749490|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1835|TWO_SIDED|95.0|0.71|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.02|0.71|0.1835
71749491|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0107|TWO_SIDED|95.0|1.51|22.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.69|1.51|0.0107
71749492|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.94||||0.0576|TWO_SIDED|95.0|0.97|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.96|0.97|0.0576
71749493|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|9.68||||0.0047|TWO_SIDED|95.0|2.0|46.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.77|2.00|0.0047
71749494|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0569|TWO_SIDED|95.0|0.97|8.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.64|0.97|0.0569
71749495|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.35||||0.1078|TWO_SIDED|95.0|0.83|6.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.68|0.83|0.1078
71749496|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0772|TWO_SIDED|95.0|0.9|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.47|0.90|0.0772
71749497|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1311|TWO_SIDED|95.0|0.77|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.22|0.77|0.1311
71813081|NCT01337986|143128518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Mixed Models Analysis|||Change in EDTRS between Visits 2 and 3.||||.29
71668165|NCT02028676|142852910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.29|1.94|||Regression, Cox|||||1.94|1.29|<0.001
71891527|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.025||0.7577|TWO_SIDED|95.0|-0.042|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom|spatial power covariance structure for within-patient errors|||0.058|-0.042|0.7577
71781253|NCT01663532|143062129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.||-1.6|-4.1|<.0001
71781254|NCT01663532|143062130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.0001|TWO_SIDED|95.0|4.1|10.1|||ANCOVA|ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.|Difference in least square mean of change were derived from ANCOVA model.|Statistical analysis for Week 10.||10.1|4.1|<.0001
71781255|NCT01663532|143062131|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||||<.0001
71781256|NCT01663532|143062132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.0001|TWO_SIDED|95.0|12.9|32.4|||Cochran-Mantel-Haenszel|CMH test controlling by region (pooled sites).||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.||32.4|12.9|<.0001
71781257|NCT01513343|143062200|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|Multinomial logistic regression examined program effects on child BMI categories, controlling for child sex, age (months), \& BMI z-score at pretest.||||||<0.05
71781258|NCT01513343|143062201|SUPERIORITY||||||<|0.05||||||To control for type I errors, the critical P values for each assessment were determined with the unweighted Bonferroni method, dividing the critical value of P \< 0.05 by the number of comparisons conducted for a given assessment.|Mixed Models Analysis|||||||<0.05
71781259|NCT01517711|143062217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286||||||P value is for overall post-randomization CAPS score|ANOVA|||Women were excluded from analysis because of the small sample size and unequal distribution across groups.||||0.286
71781260|NCT01517711|143062218|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.1|||||||ANOVA|||||||<0.10
71781261|NCT01517711|143062219|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.03|||||||ANOVA|||Analysis is for sleep only (men)||||=0.03
71781262|NCT00555971|143062228|EQUIVALENCE|This was a statistical analysis to address the null hypothesis that there was no difference between treatment and placebo groups.||||||0.036|||||||Fisher Exact|||||||0.036
71781263|NCT02571777|143062242|SUPERIORITY||LS Mean|0.065|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.031|0.099|||Mixed Model for Repeated Measures (MMRM)|||||0.099|0.031|<0.001
71781264|NCT02571777|143062242|SUPERIORITY||LS Mean|0.076|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.041|0.111|||MMRM|||||0.111|0.041|<0.001
71781265|NCT02571777|143062243|SUPERIORITY||LS Mean|0.014|STANDARD_ERROR_OF_MEAN|0.0406||0.729|TWO_SIDED|95.0|-0.066|0.094|||MMRM|||Week 26||0.094|-0.066|0.729
71781266|NCT02571777|143062243|SUPERIORITY||LS Mean|-0.086|STANDARD_ERROR_OF_MEAN|0.0404||0.034|TWO_SIDED|95.0|-0.165|-0.006|||MMRM|||Week 26||-0.006|-0.165|0.034
71781267|NCT02571777|143062243|SUPERIORITY||LS Mean|-0.071|STANDARD_ERROR_OF_MEAN|0.0409||0.085|TWO_SIDED|95.0|-0.151|0.01|||MMRM|||Week 26||0.010|-0.151|0.085
71781268|NCT02571777|143062243|SUPERIORITY||LS Mean|-0.084|STANDARD_ERROR_OF_MEAN|0.0406||0.038|TWO_SIDED|95.0|-0.164|-0.005|||MMRM|||Week 26||-0.005|-0.164|0.038
71781269|NCT02571777|143062243|SUPERIORITY||LS Mean|-0.059|STANDARD_ERROR_OF_MEAN|0.0415||0.157|TWO_SIDED|95.0|-0.14|0.023|||MMRM|||Week 52||0.023|-0.140|0.157
71781270|NCT02571777|143062243|SUPERIORITY||LS Mean|-0.121|STANDARD_ERROR_OF_MEAN|0.0414||0.003|TWO_SIDED|95.0|-0.202|-0.04|||MMRM|||Week 52||-0.040|-0.202|0.003
71781271|NCT02571777|143062243|SUPERIORITY||LS Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.042||0.814|TWO_SIDED|95.0|-0.092|0.072|||MMRM|||Week 52||0.072|-0.092|0.814
71781272|NCT02571777|143062243|SUPERIORITY||LS Mean|0.008|STANDARD_ERROR_OF_MEAN|0.0416||0.845|TWO_SIDED|95.0|-0.073|0.09|||MMRM|||Week 52||0.090|-0.073|0.845
71781273|NCT02571777|143062244|SUPERIORITY||LS Mean|0.119|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.085|0.154|||MMRM|||||0.154|0.085|<0.001
71781274|NCT02571777|143062244|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.0177|<|0.001|TWO_SIDED|95.0|0.064|0.133|||MMRM|||||0.133|0.064|<0.001
71781275|NCT02571777|143062245|SUPERIORITY||LS Mean|0.086|STANDARD_ERROR_OF_MEAN|0.0176|<|0.001|TWO_SIDED|95.0|0.051|0.12|||MMRM|||||0.120|0.051|<0.001
71781276|NCT02571777|143062245|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.111|0.18|||MMRM|||||0.180|0.111|<0.001
71781277|NCT02571777|143062245|SUPERIORITY||LS Mean|0.062|STANDARD_ERROR_OF_MEAN|0.0178|<|0.001|TWO_SIDED|95.0|0.027|0.096|||MMRM|||||0.096|0.027|<0.001
71781278|NCT02571777|143062245|SUPERIORITY||LS Mean|0.087|STANDARD_ERROR_OF_MEAN|0.0179|<|0.001|TWO_SIDED|95.0|0.052|0.122|||MMRM|||||0.122|0.052|<0.001
71781279|NCT02571777|143062246|SUPERIORITY||LS Mean|0.073|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.03|0.116|||MMRM|||Week 4||0.116|0.030|<0.001
71781280|NCT02571777|143062246|SUPERIORITY||LS Mean|0.139|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|95.0|0.096|0.181|||MMRM|||Week 4||0.181|0.096|<0.001
71781281|NCT02571777|143062246|SUPERIORITY||LS Mean|0.039|STANDARD_ERROR_OF_MEAN|0.022||0.074|TWO_SIDED|95.0|-0.004|0.082|||MMRM|||Week 4||0.082|-0.004|0.074
71781282|NCT02571777|143062246|SUPERIORITY||LS Mean|0.108|STANDARD_ERROR_OF_MEAN|0.0219|<|0.001|TWO_SIDED|95.0|0.065|0.15|||MMRM|||Week 4||0.150|0.065|<0.001
71781283|NCT02571777|143062246|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0219||0.01|TWO_SIDED|95.0|0.014|0.099|||MMRM|||Week 12||0.099|0.014|0.010
71891528|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.061|0.16||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.160|0.061|<0.0001
71781284|NCT02571777|143062246|SUPERIORITY||LS Mean|0.102|STANDARD_ERROR_OF_MEAN|0.0218|<|0.001|TWO_SIDED|95.0|0.059|0.145|||MMRM|||Week 12||0.145|0.059|<0.001
71781285|NCT02571777|143062246|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0221||0.022|TWO_SIDED|95.0|0.007|0.094|||MMRM|||Week 12||0.094|0.007|0.022
71781286|NCT02571777|143062246|SUPERIORITY||LS Mean|0.099|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.056|0.142|||MMRM|||Week 12||0.142|0.056|<0.001
71781287|NCT02571777|143062247|SUPERIORITY||LS Mean|0.095|STANDARD_ERROR_OF_MEAN|0.0254|<|0.001|TWO_SIDED|95.0|0.045|0.145|||MMRM|||||0.145|0.045|<0.001
71781288|NCT02571777|143062247|SUPERIORITY||LS Mean|0.147|STANDARD_ERROR_OF_MEAN|0.0256|<|0.001|TWO_SIDED|95.0|0.097|0.198|||MMRM|||||0.198|0.097|<0.001
71781289|NCT02571777|143062247|SUPERIORITY||LS Mean|0.049|STANDARD_ERROR_OF_MEAN|0.0256||0.057|TWO_SIDED|95.0|-0.001|0.099|||MMRM|||||0.099|-0.001|0.057
71781290|NCT02571777|143062247|SUPERIORITY||LS Mean|0.056|STANDARD_ERROR_OF_MEAN|0.0258||0.029|TWO_SIDED|95.0|0.006|0.107|||MMRM|||||0.107|0.006|0.029
71781291|NCT02571777|143062248|SUPERIORITY||LS Mean|18.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|13.2|23.3|||Linear Mixed Model (LMM)|||Week 26 - Mean morning PEF||23.3|13.2|<0.001
71781292|NCT02571777|143062248|SUPERIORITY||LS Mean|35.3|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|30.2|40.3|||LMM|||Week 26 - Mean morning PEF||40.3|30.2|<0.001
71891529|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0007|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.136|0.037|0.0007
71781293|NCT02571777|143062248|SUPERIORITY||LS Mean|14.9|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|9.8|20.0|||LMM|||Week 26 - Mean morning PEF||20.0|9.8|<0.001
71781294|NCT02571777|143062248|SUPERIORITY||LS Mean|28.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|22.9|33.1|||LMM|||Week 26 - Mean morning PEF||33.1|22.9|<0.001
71891530|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0621|TWO_SIDED|95.0|-0.002|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.097|-0.002|0.0621
71781295|NCT02571777|143062248|SUPERIORITY||LS Mean|16.8|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|11.8|21.7|||LMM|||Week 26 - Mean evening PEF||21.7|11.8|<0.001
71781296|NCT02571777|143062248|SUPERIORITY||LS Mean|29.1|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|24.2|34.1|||LMM|||Week 26 - Mean evening PEF||34.1|24.2|<0.001
71781297|NCT02571777|143062248|SUPERIORITY||LS Mean|14.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|9.1|19.1|||LMM|||Week 26 - Mean evening PEF||19.1|9.1|<0.001
71781298|NCT02571777|143062248|SUPERIORITY||LS Mean|24.3|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|19.3|29.3|||LMM|||Week 26 - Mean evening PEF||29.3|19.3|<0.001
71781299|NCT02571777|143062248|SUPERIORITY||LS Mean|18.7|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|13.4|24.1|||LMM|||Week 52 - Mean morning PEF||24.1|13.4|<0.001
71781300|NCT02571777|143062248|SUPERIORITY||LS Mean|34.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|29.5|40.1|||LMM|||Week 52 - Mean morning PEF||40.1|29.5|<0.001
71781301|NCT02571777|143062248|SUPERIORITY||LS Mean|15.6|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|10.2|20.9|||LMM|||Week 52 - Mean morning PEF||20.9|10.2|<0.001
71781302|NCT02571777|143062248|SUPERIORITY||LS Mean|28.5|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|23.2|33.8|||LMM|||Week 52 - Mean morning PEF||33.8|23.2|<0.001
71781303|NCT02571777|143062248|SUPERIORITY||LS Mean|17.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|12.3|22.8|||LMM|||Week 52 - Mean evening PEF||22.8|12.3|<0.001
71781304|NCT02571777|143062248|SUPERIORITY||LS Mean|29.5|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|24.2|34.7|||LMM|||Week 52 - Mean evening PEF||34.7|24.2|<0.001
71781305|NCT02571777|143062248|SUPERIORITY||LS Mean|15.0|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|9.7|20.2|||LMM|||Week 52 - Mean evening PEF||20.2|9.7|<0.001
71781306|NCT02571777|143062248|SUPERIORITY||LS Mean|25.8|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|20.5|31.0|||LMM|||Week 52 - Mean evening PEF||31.0|20.5|<0.001
71781307|NCT02571777|143062249|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.81||0.907|TWO_SIDED|95.0|-3.3|3.8|||LMM|||||3.8|-3.3|0.907
71781308|NCT02571777|143062249|SUPERIORITY||LS Mean|3.5|STANDARD_ERROR_OF_MEAN|1.81||0.055|TWO_SIDED|95.0|-0.1|7.0|||LMM|||||7.0|-0.1|0.055
71781309|NCT02571777|143062249|SUPERIORITY||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.83||0.997|TWO_SIDED|95.0|-3.6|3.6|||LMM|||||3.6|-3.6|0.997
71781310|NCT02571777|143062249|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.82||0.606|TWO_SIDED|95.0|-4.5|2.6|||LMM|||||2.6|-4.5|0.606
71781311|NCT02571777|143062250|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.78||0.712|TWO_SIDED|95.0|-2.8|4.2|||LMM|||||4.2|-2.8|0.712
71781312|NCT02571777|143062250|SUPERIORITY||LS Mean|3.7|STANDARD_ERROR_OF_MEAN|1.78||0.038|TWO_SIDED|95.0|0.2|7.2|||LMM|||||7.2|0.2|0.038
71781313|NCT02571777|143062250|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.943|TWO_SIDED|95.0|-3.7|3.4|||LMM|||||3.4|-3.7|0.943
71781314|NCT02571777|143062250|SUPERIORITY||LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|1.79||0.612|TWO_SIDED|95.0|-4.4|2.6|||LMM|||||2.6|-4.4|0.612
71781315|NCT02571777|143062251|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.51||0.809|TWO_SIDED|95.0|-3.3|2.6|||LMM|||||2.6|-3.3|0.809
71781316|NCT02571777|143062251|SUPERIORITY||LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.5||0.467|TWO_SIDED|95.0|-1.9|4.0|||LMM|||||4.0|-1.9|0.467
71781317|NCT02571777|143062251|SUPERIORITY||LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.318|TWO_SIDED|95.0|-1.5|4.5|||LMM|||||4.5|-1.5|0.318
71749498|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.64||||0.01255|TWO_SIDED|95.0|1.45|21.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||21.96|1.45|0.01255
71749499|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.97||||0.0128|TWO_SIDED|95.0|1.41|17.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.54|1.41|0.0128
71749500|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|6.32||||0.0079|TWO_SIDED|95.0|1.62|24.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||24.63|1.62|0.0079
71749501|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0572|TWO_SIDED|95.0|0.97|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.67|0.97|0.0572
71749502|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0284|TWO_SIDED|95.0|1.14|9.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.79|1.14|0.0284
71781318|NCT02571777|143062251|SUPERIORITY||LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.51||0.64|TWO_SIDED|95.0|-2.3|3.7|||LMM|||||3.7|-2.3|0.640
71781319|NCT02571777|143062252|SUPERIORITY||LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.83||0.814|TWO_SIDED|95.0|-4.0|3.2|||LMM|||||3.2|-4.0|0.814
71891531|NCT01431287|143304567|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.025||0.1266|TWO_SIDED|95.0|-0.011|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.089|-0.011|0.1266
71749503|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0705|TWO_SIDED|95.0|0.92|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.22|0.92|0.0705
71749504|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.81||||0.0136|TWO_SIDED|95.0|1.38|16.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.77|1.38|0.0136
71749505|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|9.96||||0.0043|TWO_SIDED|95.0|2.06|48.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||48.29|2.06|0.0043
71749506|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.66||||0.076|TWO_SIDED|95.0|0.9|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.83|0.90|0.0760
71749507|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|5.75||||0.0059|TWO_SIDED|95.0|1.65|20.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.00|1.65|0.0059
71749508|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|4.22||||0.0143|TWO_SIDED|95.0|1.33|13.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.35|1.33|0.0143
71781320|NCT02571777|143062252|SUPERIORITY||LS Mean|3.8|STANDARD_ERROR_OF_MEAN|1.83||0.036|TWO_SIDED|95.0|0.2|7.4|||LMM|||||7.4|0.2|0.036
71781321|NCT02571777|143062252|SUPERIORITY||LS Mean|3.1|STANDARD_ERROR_OF_MEAN|1.84||0.098|TWO_SIDED|95.0|-0.6|6.7|||LMM|||||6.7|-0.6|0.098
71781322|NCT02571777|143062252|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.84||0.118|TWO_SIDED|95.0|-0.7|6.5|||LMM|||||6.5|-0.7|0.118
71781323|NCT02571777|143062253|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
71781324|NCT02571777|143062253|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
71781325|NCT02571777|143062253|SUPERIORITY||LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
71781326|NCT02571777|143062253|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
71781327|NCT02571777|143062253|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
71781328|NCT02571777|143062253|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
71781329|NCT02571777|143062253|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
71781330|NCT02571777|143062253|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
71781331|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|0.92||||0.535|TWO_SIDED|95.0|0.7|1.2|||Logistic regression model|||Week 26||1.20|0.70|0.535
71781332|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|1.21||||0.151|TWO_SIDED|95.0|0.93|1.57|||Logistic regression model|||Week 26||1.57|0.93|0.151
71677068|NCT00356135|142872620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.91|||<|0.0001||95.0|-19.1|-8.73|||ANOVA|Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.|Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.|||-8.73|-19.10|<0.0001
71749509|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2779|TWO_SIDED|95.0|0.62|5.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.35|0.62|0.2779
71749510|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7559|TWO_SIDED|95.0|0.41|3.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.41|0.41|0.7559
71749511|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.07||||0.905|TWO_SIDED|95.0|0.35|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.23|0.35|0.9050
71749512|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2163|TWO_SIDED|95.0|0.66|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.38|0.66|0.2163
71749513|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1713|TWO_SIDED|95.0|0.7|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.14|0.70|0.1713
71749514|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3981|TWO_SIDED|95.0|0.52|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.09|0.52|0.3981
71749515|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9692|TWO_SIDED|95.0|0.35|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.96|0.35|0.9692
71749516|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.77||||0.2978|TWO_SIDED|95.0|0.6|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.22|0.60|0.2978
71749517|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8525|TWO_SIDED|95.0|0.38|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.38|0.8525
71749518|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5028|TWO_SIDED|95.0|0.21|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.13|0.21|0.5028
71749519|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4594|TWO_SIDED|95.0|0.5|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.73|0.50|0.4594
71749520|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1124|TWO_SIDED|95.0|0.8|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||8.17|0.80|0.1124
71749521|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3415|TWO_SIDED|95.0|0.55|5.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.58|0.55|0.3415
71749522|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3635|TWO_SIDED|95.0|0.56|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.83|0.56|0.3635
71781333|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|1.13||||0.38|TWO_SIDED|95.0|0.86|1.48|||Logistic regression model|||Week 26||1.48|0.86|0.380
71781334|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|1.2||||0.172|TWO_SIDED|95.0|0.92|1.57|||Logistic regression model|||Week 26||1.57|0.92|0.172
71781335|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|1.1||||0.51|TWO_SIDED|95.0|0.83|1.47|||Logistic regression model|||Week 52||1.47|0.83|0.510
71781336|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|1.41||||0.017|TWO_SIDED|95.0|1.06|1.86|||Logistic regression model|||Week 52||1.86|1.06|0.017
71781337|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|1.05||||0.744|TWO_SIDED|95.0|0.79|1.38|||Logistic regression model|||Week 52||1.38|0.79|0.744
71781338|NCT02571777|143062254|SUPERIORITY||Odds Ratio (OR)|0.99||||0.922|TWO_SIDED|95.0|0.75|1.29|||Logistic regression model|||Week 52||1.29|0.75|0.922
71781339|NCT02571777|143062255|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.371|TWO_SIDED|95.0|0.27|1.63|||Regression, Cox|||||1.63|0.27|0.371
71668166|NCT02028676|142852911|NON_INFERIORITY_OR_EQUIVALENCE|631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).|Risk Difference (RD)|-1.6||||0.65|TWO_SIDED|95.0|-8.4|5.2|||Chi-squared||Difference in suppression \<80 copies/ml in once-daily minus twice-daily|||5.2|-8.4|0.65
71781340|NCT02571777|143062255|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.996|TWO_SIDED|95.0|0.37|2.66|||Regression, Cox|||||2.66|0.37|0.996
71781341|NCT02571777|143062255|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.145|TWO_SIDED|95.0|0.8|4.47|||Regression, Cox|||||4.47|0.80|0.145
71781342|NCT02571777|143062255|SUPERIORITY||Hazard Ratio (HR)|1.88||||0.15|TWO_SIDED|95.0|0.8|4.43|||Regression, Cox|||||4.43|0.80|0.150
71781343|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.523|TWO_SIDED|95.0|0.77|1.15|||Regression, Cox|||Moderate or severe asthma exacerbation||1.15|0.77|0.523
71781344|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Regression, Cox|||Moderate or severe asthma exacerbation||0.84|0.58|<0.001
71891532|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.104|0.209||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.209|0.104|<0.0001
71781345|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.72|1.06|||Regression, Cox|||Moderate or severe asthma exacerbation||1.06|0.72|0.164
71781346|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.005|TWO_SIDED|95.0|0.63|0.92|||Regression, Cox|||Moderate or severe asthma exacerbation||0.92|0.63|0.005
71781347|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.476|TWO_SIDED|95.0|0.72|1.16|||Regression, Cox|||Severe asthma exacerbation||1.16|0.72|0.476
71781348|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.54|0.85|||Regression, Cox|||Severe asthma exacerbation||0.85|0.54|<0.001
71781349|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.243|TWO_SIDED|95.0|0.7|1.09|||Regression, Cox|||Severe asthma exacerbation||1.09|0.70|0.243
71781350|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.027|TWO_SIDED|95.0|0.63|0.97|||Regression, Cox|||Severe asthma exacerbation||0.97|0.63|0.027
71781351|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.497|TWO_SIDED|95.0|0.79|1.12|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.12|0.79|0.497
71677069|NCT00356135|142872620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.98|||<|0.0001||95.0|-19.26|-8.71|||ANCOVA|||||-8.71|-19.26|<0.0001
71781352|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.84|0.60|<0.001
71781353|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.126|TWO_SIDED|95.0|0.73|1.04|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||1.04|0.73|0.126
71781354|NCT02571777|143062256|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.61|0.85|||Regression, Cox|||All (mild, moderate, severe) asthma exacerbation||0.85|0.61|<0.001
71781355|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.85||||0.12|TWO_SIDED|95.0|0.68|1.04|||Generalized linear model|||Moderate or severe asthma exacerbation||1.04|0.68|0.120
71781356|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.52|0.78|||Generalized linear model|||Moderate or severe asthma exacerbation||0.78|0.52|<0.001
71781357|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.87||||0.17|TWO_SIDED|95.0|0.71|1.06|||Generalized linear modeñ|||Moderate or severe asthma exacerbation||1.06|0.71|0.170
71781358|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.81||||0.041|TWO_SIDED|95.0|0.66|0.99|||Generalized linear model|||Moderate or severe asthma exacerbation||0.99|0.66|0.041
71781359|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.78||||0.05|TWO_SIDED|95.0|0.61|1.0|||Generalized linear model|||Severe asthma exacerbation||1.00|0.61|0.050
71781360|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.73|||Generalized linear model|||Severe asthma exacerbation||0.73|0.45|<0.001
71781361|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.93||||0.531|TWO_SIDED|95.0|0.74|1.17|||Generalized linear model|||Severe asthma exacerbation||1.17|0.74|0.531
71781362|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Linear generalized model|||Severe asthma exacerbation||1.05|0.67|0.117
71781363|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.79||||0.016|TWO_SIDED|95.0|0.66|0.96|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.96|0.66|0.016
71781364|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.6|||<|0.001|TWO_SIDED|95.0|0.5|0.72|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.72|0.50|<0.001
71781365|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.87||||0.161|TWO_SIDED|95.0|0.72|1.06|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||1.06|0.72|0.161
71781366|NCT02571777|143062257|SUPERIORITY||Rate ratio|0.7|||<|0.001|TWO_SIDED|95.0|0.58|0.84|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation||0.84|0.58|<0.001
71781367|NCT02571777|143062258|SUPERIORITY|||||||0.183|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.183
71781368|NCT02571777|143062258|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation||||<0.001
71781369|NCT02571777|143062258|SUPERIORITY|||||||0.155|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.155
71781370|NCT02571777|143062258|SUPERIORITY|||||||0.007|||||||van Elteren test|||Moderate or severe asthma exacerbation||||0.007
71781371|NCT02571777|143062258|SUPERIORITY|||||||0.172|||||||van Elteren test|||Severe asthma exacerbation||||0.172
71781372|NCT02571777|143062258|SUPERIORITY||||||<|0.001|||||||van Elteren test|||Severe asthma exacerbation||||<0.001
71781373|NCT02571777|143062258|SUPERIORITY|||||||0.241|||||||van Elteren test|||Severe asthma exacerbation||||0.241
71781374|NCT02571777|143062258|SUPERIORITY|||||||0.033|||||||van Elteren test|||Severe asthma exacerbation||||0.033
71749523|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5716|TWO_SIDED|95.0|0.24|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.24|0.5716
71749524|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5028|TWO_SIDED|95.0|0.23|2.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.05|0.23|0.5028
71749525|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3982|TWO_SIDED|95.0|0.18|1.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.98|0.18|0.3982
71749526|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.3|2.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.87|0.30|0.93
71749527|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|2.12||||0.2364|TWO_SIDED|95.0|0.61|7.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.32|0.61|0.2364
71749528|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7095|TWO_SIDED|95.0|0.39|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.04|0.39|0.7095
71749529|NCT03192176|143005305|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6011|TWO_SIDED|95.0|0.26|2.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.20|0.26|0.6011
71749530|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|6.78||||0.0181|TWO_SIDED|95.0|1.39|33.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.10|1.39|0.0181
71781375|NCT02571777|143062258|SUPERIORITY|||||||0.095|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.095
71781376|NCT02571777|143062258|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
71781377|NCT02571777|143062258|SUPERIORITY|||||||0.09|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||0.090
71781378|NCT02571777|143062258|SUPERIORITY||||||<|0.001|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation||||<0.001
71781379|NCT02571777|143062260|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.314|TWO_SIDED|95.0|0.12|1.96|||Regression, Cox|||||1.96|0.12|0.314
71781380|NCT02571777|143062260|SUPERIORITY||Hazard Ratio (HR)|0.28||||0.055|TWO_SIDED|95.0|0.08|1.03|||Regression, Cox|||||1.03|0.08|0.055
71781381|NCT02571777|143062260|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.306|TWO_SIDED|95.0|0.25|1.54|||Regression, Cox|||||1.54|0.25|0.306
71749531|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|9.97||||0.0039|TWO_SIDED|95.0|2.1|47.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.48|2.10|0.0039
71749532|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|21.2||||0.0001|TWO_SIDED|95.0|4.51|99.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||99.65|4.51|0.0001
71781382|NCT02571777|143062260|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.566|TWO_SIDED|95.0|0.3|1.94|||Regression, Cox|||||1.94|0.30|0.566
71781383|NCT02571777|143062262|SUPERIORITY||LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.74||0.645|TWO_SIDED|95.0|-4.2|2.6|||LMM|||Week 26||2.6|-4.2|0.645
71781384|NCT02571777|143062262|SUPERIORITY||LS Mean|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.095|TWO_SIDED|95.0|-0.5|6.3|||LMM|||Week 26||6.3|-0.5|0.095
71781385|NCT02571777|143062262|SUPERIORITY||LMM|1.3|STANDARD_ERROR_OF_MEAN|1.75||0.46|TWO_SIDED|95.0|-2.1|4.7|||LMM|||Week 26||4.7|-2.1|0.460
71781386|NCT02571777|143062262|SUPERIORITY||LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.75||0.971|TWO_SIDED|95.0|-3.5|3.4|||LMM|||Week 26||3.4|-3.5|0.971
71781387|NCT02571777|143062262|SUPERIORITY||LMM|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.963|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.963
71781388|NCT02571777|143062262|SUPERIORITY||LS Mean|3.2|STANDARD_ERROR_OF_MEAN|1.77||0.075|TWO_SIDED|95.0|-0.3|6.6|||LMM|||Week 52||6.6|-0.3|0.075
71781389|NCT02571777|143062262|SUPERIORITY||LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.79||0.517|TWO_SIDED|95.0|-2.3|4.7|||LMM|||Week 52||4.7|-2.3|0.517
71781390|NCT02571777|143062262|SUPERIORITY||LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.78||0.956|TWO_SIDED|95.0|-3.4|3.6|||LMM|||Week 52||3.6|-3.4|0.956
71781391|NCT02571777|143062263|SUPERIORITY||LS Mean|0.02|STANDARD_ERROR_OF_MEAN|0.0502||0.69|TWO_SIDED|95.0|-0.078|0.118|||MMRM|||||0.118|-0.078|0.690
71781392|NCT02571777|143062263|SUPERIORITY||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.0502||0.232|TWO_SIDED|95.0|-0.038|0.159|||MMRM|||||0.159|-0.038|0.232
71781393|NCT02571777|143062263|SUPERIORITY||LS Mean|-0.054|STANDARD_ERROR_OF_MEAN|0.0506||0.285|TWO_SIDED|95.0|-0.153|0.045|||MMRM|||||0.045|-0.153|0.285
71781394|NCT02571777|143062263|SUPERIORITY||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.0505||0.319|TWO_SIDED|95.0|-0.15|0.049|||MMRM|||||0.049|-0.150|0.319
71781395|NCT02571777|143062264|SUPERIORITY||LS Mean|0.068|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.036|0.101|||MMRM|||Week 4||0.101|0.036|<0.001
71781396|NCT02571777|143062264|SUPERIORITY||LS Mean|0.145|STANDARD_ERROR_OF_MEAN|0.0165|<|0.001|TWO_SIDED|95.0|0.113|0.177|||MMRM|||Week 4||0.177|0.113|<0.001
71668167|NCT02028676|142852913|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Hazard Ratio (HR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.37|||Log Rank||Hazard ratio is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough"||2.37|1.14|0.007
71781397|NCT02571777|143062264|SUPERIORITY||LS Mean|0.033|STANDARD_ERROR_OF_MEAN|0.0167||0.049|TWO_SIDED|95.0|0.0|0.066|||MMRM|||Week 4||0.066|0.000|0.049
71749533|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|23.97|||<|0.0001|TWO_SIDED|95.0|5.09|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||112.9|5.09|<0.0001
71781398|NCT02571777|143062264|SUPERIORITY||LS Mean|0.096|STANDARD_ERROR_OF_MEAN|0.0166|<|0.001|TWO_SIDED|95.0|0.064|0.129|||MMRM|||Week 4||0.129|0.064|<0.001
71781399|NCT02571777|143062264|SUPERIORITY||LS Mean|0.058|STANDARD_ERROR_OF_MEAN|0.0184||0.002|TWO_SIDED|95.0|0.022|0.094|||MMRM|||Week 12||0.094|0.022|0.002
71781400|NCT02571777|143062264|SUPERIORITY||LS Mean|0.117|STANDARD_ERROR_OF_MEAN|0.0183|<|0.001|TWO_SIDED|95.0|0.081|0.153|||MMRM|||Week 12||0.153|0.081|<0.001
71781401|NCT02571777|143062264|SUPERIORITY||LS Mean|0.05|STANDARD_ERROR_OF_MEAN|0.0185||0.007|TWO_SIDED|95.0|0.013|0.086|||MMRM|||Week 12||0.086|0.013|0.007
71781402|NCT02571777|143062264|SUPERIORITY||MMRM|0.087|STANDARD_ERROR_OF_MEAN|0.0184|<|0.001|TWO_SIDED|95.0|0.051|0.123|||MMRM|||Week 12||0.123|0.051|<0.001
71781403|NCT00801632|143062266|SUPERIORITY_OR_OTHER||Percentage of Participants|60.0|||||TWO_SIDED|95.0|14.7|94.7|||||Clopper-Pearson used to derive confidence interval|||94.7|14.7|
71781404|NCT00801632|143062268|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.|t-test, 2 sided|The test describes whether the average of the difference is different from zero.||||||0.215
71781405|NCT00621582|143062277|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||comparing results of post-treatment global assessment by patient with that of pre-treatment||||0.01
71749534|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.17||||0.1766|TWO_SIDED|95.0|0.59|16.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.87|0.59|0.1766
71781406|NCT00087607|143062294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.978|TWO_SIDED|95.0|-0.35|0.36|||t-test, 2 sided|||Mean treatment difference was tested using a two-sided t-test.||0.36|-0.35|0.978
71781407|NCT00087607|143062295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.08|TWO_SIDED|95.0|-0.03|0.58|||t-test, 2 sided|||At Week 4: Mean treatment difference was tested using a two-sided t-test.||0.58|-0.03|0.080
71781408|NCT00087607|143062295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.688|TWO_SIDED|95.0|-0.27|0.41|||t-test, 2 sided|||At Week 8: Mean treatment difference was tested using a two-sided t-test.||0.41|-0.27|0.688
71781409|NCT00087607|143062299|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANOVA|||The treatment groups were compared using an analysis of variance (ANOVA) with treatment as the only factor in the model.||||0.304
71781410|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.1||||0.2814|TWO_SIDED|95.0|-8.6|2.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||2.5|-8.6|0.2814
71781411|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.3||||0.0214|TWO_SIDED|95.0|-18.9|-1.6|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||-1.6|-18.9|0.0214
71781412|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-10.7||||0.0315|TWO_SIDED|95.0|-20.3|-1.0|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||-1.0|-20.3|0.0315
71781413|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-7.4||||0.1467|TWO_SIDED|95.0|-17.4|2.6|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||2.6|-17.4|0.1467
71781414|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.8||||0.1823|TWO_SIDED|95.0|-16.9|3.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||3.2|-16.9|0.1823
71781415|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.1||||0.6871|TWO_SIDED|95.0|-12.1|8.0|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||8.0|-12.1|0.6871
71781416|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.4||||0.9295|TWO_SIDED|95.0|-10.4|9.5|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||9.5|-10.4|0.9295
71781417|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6593|TWO_SIDED|95.0|-7.6|12.1|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||12.1|-7.6|0.6593
71781418|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.2||||0.6637|TWO_SIDED|95.0|-7.7|12.1|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||12.1|-7.7|0.6637
71781419|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.276|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2760
71781420|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|5.4||||0.2779|TWO_SIDED|95.0|-4.3|15.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||15.1|-4.3|0.2779
71668168|NCT02028676|142852913|NON_INFERIORITY_OR_EQUIVALENCE|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Risk Difference (RD)|4.0||||0.006|TWO_SIDED|95.0|0.8|7.2|||Poisson regression for risk difference||Risk difference is stop vs continue.|"Assumptions~* 5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~* recruitment starts 1 July 2009 with 10% children (those already on ART for \>96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~* cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough."||7.2|0.8|0.006
71781421|NCT00087607|143062301|SUPERIORITY_OR_OTHER||Difference in proportion of participants|2.8||||0.5697|TWO_SIDED|95.0|-6.8|12.4|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||12.4|-6.8|0.5697
71781422|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|0.0||||0.994|TWO_SIDED|95.0|-1.4|1.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.||1.5|-1.4|0.9940
71781423|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-0.5||||0.7133|TWO_SIDED|95.0|-3.2|2.2|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.||2.2|-3.2|0.7133
71668169|NCT02028676|142852914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.33|TWO_SIDED|95.0|0.83|1.72|||Log Rank||Hazard ratio is stop vs continue.|||1.72|0.83|0.33
71668170|NCT02028676|142852915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.45|TWO_SIDED|95.0|0.49|1.44|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.44|0.49|0.45
71668171|NCT02028676|142852915|SUPERIORITY_OR_OTHER|||||||0.43|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.43
71668172|NCT02028676|142852915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.23|TWO_SIDED|95.0|0.33|1.31|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.31|0.33|0.23
71781424|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.6||||0.0864|TWO_SIDED|95.0|-7.8|0.5|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.||0.5|-7.8|0.0864
71781425|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.1||||0.1713|TWO_SIDED|95.0|-10.0|1.8|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.||1.8|-10.0|0.1713
71781426|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.6||||0.1888|TWO_SIDED|95.0|-11.4|2.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.||2.2|-11.4|0.1888
71781427|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.6||||0.108|TWO_SIDED|95.0|-14.7|1.4|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.||1.4|-14.7|0.1080
71781428|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.5||||0.3099|TWO_SIDED|95.0|-13.1|4.2|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.||4.2|-13.1|0.3099
71781429|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-3.4||||0.4595|TWO_SIDED|95.0|-12.4|5.6|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.||5.6|-12.4|0.4595
71668173|NCT02028676|142852915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.93|TWO_SIDED|95.0|0.52|1.81|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.81|0.52|0.93
71781430|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-6.0||||0.2144|TWO_SIDED|95.0|-15.4|3.4|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.||3.4|-15.4|0.2144
71668174|NCT02028676|142852916|SUPERIORITY_OR_OTHER|||||||0.89|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.89
71781431|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-5.4||||0.2779|TWO_SIDED|95.0|-15.1|4.3|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.||4.3|-15.1|0.2779
71668175|NCT02028676|142852916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.48|0.53|0.64
71668176|NCT02028676|142852916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.52|0.54|0.71
71781432|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-2.7||||0.5876|TWO_SIDED|95.0|-12.6|7.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.||7.1|-12.6|0.5876
71781433|NCT00087607|143062302|SUPERIORITY_OR_OTHER||Difference in proportion of participants|-4.8||||0.3399|TWO_SIDED|95.0|-14.7|5.1|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.||5.1|-14.7|0.3399
71781434|NCT00087607|143062307|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Repeated measures analysis|The P-value is determined from a repeated measures analysis with terms for treatment group, baseline, week, and the week-by-treatment interaction.||Week 1: The treatment groups were compared using repeated measures analysis||||0.024
71781435|NCT00087607|143062307|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated measures analysis|||Week 8: The treatment groups were compared using Repeated measures analysis||||<0.001
71781436|NCT00668707|143062389|SUPERIORITY||Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.83|1.22|||Regression, Logistic|||Analysis conducted was an adjusted logistic regression (adjuvant chemotherapy, adjuvant radiation, smoking history). Results were presented as a relative risk. Based on an estimated 30% outcome rate of recurrence or mortality in the control arm, 294 participants per arm provided 80% power to detect a relative risk of one third at an alpha of 0.05. We inflated this sample size to 346 per arm to account for 15% lost to follow-up.||1.22|0.83|0.94
71781437|NCT00668707|143062390|SUPERIORITY||Mean Difference (Net)|1.2||||0.36|TWO_SIDED|95.0|-1.3|3.7|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Analysis for the LC-13 scale.||3.7|-1.3|0.36
71668177|NCT02028676|142852917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.73|1.38|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.38|0.73|0.98
71668178|NCT02028676|142852917|SUPERIORITY_OR_OTHER|||||||0.44|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.44
71668179|NCT02028676|142852917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.3|TWO_SIDED|95.0|0.55|1.2|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.20|0.55|0.30
71781438|NCT00668707|143062390|SUPERIORITY||Mean Difference (Net)|0.4||||0.8|TWO_SIDED|95.0|-2.5|3.3||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Symptom Scale.||3.3|-2.5|0.80
71781439|NCT00668707|143062390|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.1|2.7||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Functional Scale.||2.7|-4.1|0.69
71781440|NCT00668707|143062390|SUPERIORITY||Mean Difference (Net)|-3.8||||0.11|TWO_SIDED|95.0|-8.5|0.9||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.|Mixed Models Analysis|||Analysis for Global Scale.||0.9|-8.5|0.11
71781441|NCT00668707|143062391|SUPERIORITY||Mean Difference (Net)|-3.1||||0.13|TWO_SIDED|95.0|-7.2|0.9|||Mixed Models Analysis|||Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||0.9|-7.2|0.13
71781442|NCT00668707|143062392|SUPERIORITY||Mean Difference (Net)|-4.1||||0.18|TWO_SIDED|95.0|-10.0|1.9|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep Adequacy Analysis.||1.9|-10.0|0.18
71781443|NCT00668707|143062392|SUPERIORITY||Mean Difference (Net)|1.4||||0.41|TWO_SIDED|95.0|-2.0|4.8|||Mixed Models Analysis|Between-arm least squares mean difference in change from randomization to 24 months post-surgery represented the effect of the intervention.||Sleep problems index II analysis.||4.8|-2.0|0.41
71781444|NCT00668707|143062396|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71781445|NCT00668707|143062397|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.41|TWO_SIDED|95.0|0.85|1.07|||Log Rank|||DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.07|0.85|0.41
71781446|NCT00668707|143062397|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66|TWO_SIDED|95.0|0.85|1.11|||Log Rank|||This analysis included only those with stage I or II cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||1.11|0.85|0.66
71668180|NCT02028676|142852917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.24|TWO_SIDED|95.0|0.54|1.17|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.17|0.54|0.24
71668181|NCT02028676|142852918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.52|TWO_SIDED|95.0|0.82|1.49|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM.|||1.49|0.82|0.52
71781447|NCT00668707|143062397|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.92|||Log Rank|||This analysis included only those participants who had stage III or IV cancer (pathologic stage). DFS up to five years post-surgery was compared using Kaplan-Meier curves and the log rank test, followed by a hazard ratio calculated using the Cox proportional hazard model adjusting for adjuvant chemotherapy, adjuvant radiation, and smoking history.||0.92|0.61|0.004
71781448|NCT00668707|143062398|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.95|TWO_SIDED|95.0|-3.21|4.56|||Wilcoxon (Mann-Whitney)|||Analysis of melatonin changes||4.56|-3.21|0.95
71781449|NCT00668707|143062398|SUPERIORITY||Mean Difference (Final Values)|3.63||||0.02|TWO_SIDED|95.0|-0.15|7.42|||Wilcoxon (Mann-Whitney)|||Analysis of placebo changes||7.42|-0.15|0.02
71781450|NCT00668707|143062399|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
71781451|NCT00668707|143062400|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||This analysis compares the mean ratios of 6 month cytotoxicity and baseline cytotoxicity between arms.||||0.34
71781452|NCT03137537|143062416|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71781453|NCT03137537|143062417|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71781454|NCT03386448|143062431|SUPERIORITY|Student test was performed|Mean Difference (Final Values)|9.0||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71781455|NCT01211730|143062432|SUPERIORITY_OR_OTHER|||||||0.709|||||||Chi-squared, Corrected|||||||0.709
71781456|NCT01211730|143062433|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared, Corrected|||||||0.003
71781457|NCT01211730|143062434|SUPERIORITY_OR_OTHER|||||||0.0046|||||||Chi-squared, Corrected|||||||0.0046
71781458|NCT01211730|143062435|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared, Corrected|||||||0.75
71781459|NCT01211730|143062436|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared, Corrected|||||||0.56
71781460|NCT01211730|143062437|SUPERIORITY_OR_OTHER|||||||0.77|||||||Chi-squared, Corrected|||||||0.77
71781461|NCT03338010|143062438|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
71781462|NCT03338010|143062439|NON_INFERIORITY|0.40% noninferiority margin was used.|LS Mean Difference|-0.05||||0.545|TWO_SIDED|95.0|-0.19|0.1|||Mixed Models Analysis|||||0.10|-0.19|0.545
71781463|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|1.0||||0.602|TWO_SIDED|95.0|-2.8|4.8|||Mixed Models Analysis|||Before Morning Meal Glucose||4.8|-2.8|0.602
71781464|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|-3.7||||0.373|TWO_SIDED|95.0|-11.8|4.4|||Mixed Models Analysis|||2 Hours After Morning Meal Glucose||4.4|-11.8|0.373
71781465|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|-3.3||||0.351|TWO_SIDED|95.0|-10.3|3.7|||Mixed Models Analysis|||Before Mid-Day Meal Glucose||3.7|-10.3|0.351
71668182|NCT02028676|142852918|SUPERIORITY_OR_OTHER|||||||0.34||||||Global test with 2df, adjusted for randomization stratification factors|Log Rank|||||||0.34
71668183|NCT02028676|142852918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.19|TWO_SIDED|95.0|0.54|1.13|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.13|0.54|0.19
71668184|NCT02028676|142852918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.25|TWO_SIDED|95.0|0.56|1.16|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.16|0.56|0.25
71668185|NCT02028676|142852919|SUPERIORITY_OR_OTHER|||||||0.71|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.71
71668186|NCT02028676|142852919|SUPERIORITY_OR_OTHER|||||||0.58|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.58
71781466|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|4.9||||0.23|TWO_SIDED|95.0|-3.1|12.8|||Mixed Models Analysis|||2 Hours After Mid-Day Meal Glucose||12.8|-3.1|0.230
71781467|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|0.9||||0.819|TWO_SIDED|95.0|-6.7|8.5|||Mixed Models Analysis|||Before Evening Meal Glucose||8.5|-6.7|0.819
71781468|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|2.3||||0.588|TWO_SIDED|95.0|-6.2|10.9|||Mixed Models Analysis|||2 Hours After Evening Meal Glucose||10.9|-6.2|0.588
71781469|NCT03338010|143062440|SUPERIORITY||LS Mean Difference|1.4||||0.732|TWO_SIDED|95.0|-6.7|9.5|||Mixed Models Analysis|||Bedtime Glucose||9.5|-6.7|0.732
71781470|NCT03338010|143062441|SUPERIORITY|||||||0.846|||||||Fisher Exact|||||||0.846
71668187|NCT02028676|142852920|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
71668188|NCT02028676|142852920|SUPERIORITY_OR_OTHER|||||||0.9|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.90
71668189|NCT02028676|142852921|SUPERIORITY_OR_OTHER|||||||0.64|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.64
71668190|NCT02028676|142852921|SUPERIORITY_OR_OTHER|||||||0.3|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.30
71668191|NCT02028676|142852922|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.45
71781471|NCT03338010|143062442|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
71781472|NCT03338010|143062443|SUPERIORITY||LS Mean Difference|0.32||||0.767|TWO_SIDED|95.0|-1.78|2.42|||Mixed Models Analysis|||Morning Pre-meal Standard Deviation||2.42|-1.78|0.767
71781473|NCT03338010|143062443|SUPERIORITY||LS Mean Difference|0.4||||0.781|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||Daily Mean Standard Deviation||3.3|-2.5|0.781
71781474|NCT03338010|143062444|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
71781475|NCT03338010|143062445|SUPERIORITY||LS Mean Difference|0.2||||0.75|TWO_SIDED|95.0|-1.2|1.7|||Mixed Models Analysis|||||1.7|-1.2|0.750
71668192|NCT02028676|142852923|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.70
71668193|NCT02028676|142852924|SUPERIORITY_OR_OTHER|||||||0.59||0.0|||||Regression, Linear|Adjusted for randomization stratification factors||||||0.59
71668194|NCT02028676|142852924|SUPERIORITY_OR_OTHER|||||||0.01|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.01
71668195|NCT02028676|142852925|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Linear|Adjusted for randomization stratification factors||||||0.81
71668196|NCT02028676|142852925|SUPERIORITY_OR_OTHER|||||||0.03|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||||||0.03
71668197|NCT02028676|142852926|SUPERIORITY_OR_OTHER|||||||0.86|||||||Chi-squared|||||||0.86
71668198|NCT02028676|142852926|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
71668199|NCT02028676|142852927|SUPERIORITY_OR_OTHER|||||||0.2|||||||Chi-squared|||||||0.20
71668200|NCT02028676|142852927|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71668201|NCT02028676|142852928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.22|TWO_SIDED|95.0|0.48|1.29|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.29|0.48|0.22
71668202|NCT02028676|142852929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.672||||0.09|TWO_SIDED|95.0|0.42|1.075|||Log Rank||Hazard ratio is CDM vs LCM|||1.075|0.420|0.09
71781476|NCT03338010|143062446|SUPERIORITY||LS Mean Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-0.6|0.3|||Mixed Models Analysis|||||0.3|-0.6|<0.001
71781477|NCT03338010|143062447|SUPERIORITY||LS Mean Difference|-0.95||||0.5|TWO_SIDED|95.0|-3.72|1.82|||Mixed Models Analysis|||Inconvenience of Regimen Transformed Score||1.82|-3.72|0.500
71781478|NCT03338010|143062447|SUPERIORITY||LS Mean Difference|-3.99||||0.031|TWO_SIDED|95.0|-7.62|-0.36|||Mixed Models Analysis|||Lifestyle Flexibility Transformed Score||-0.36|-7.62|0.031
71781479|NCT03338010|143062447|SUPERIORITY||LS Mean Difference|-1.79||||0.2|TWO_SIDED|95.0|-4.53|0.95|||Mixed Models Analysis|||Hypoglycemic Control Transformed Score||0.95|-4.53|0.200
71781480|NCT03338010|143062447|SUPERIORITY||LS Mean Difference|-0.02||||0.988|TWO_SIDED|95.0|-2.92|2.88|||Mixed Models Analysis|||Glycemic Control Transformed Score||2.88|-2.92|0.988
71781481|NCT03338010|143062447|SUPERIORITY||LS Mean Difference|-1.45||||0.337|TWO_SIDED|95.0|-4.41|1.51|||Mixed Models Analysis|||Insulin Delivery Device Satisfaction Transformed Score||1.51|-4.41|0.337
71749535|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|7.68||||0.0116|TWO_SIDED|95.0|1.58|37.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||37.43|1.58|0.0116
71749536|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|12.74||||0.0013|TWO_SIDED|95.0|2.71|59.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||59.81|2.71|0.0013
71749537|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0359|TWO_SIDED|95.0|1.07|7.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.43|1.07|0.0359
71749538|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.8||||0.0004|TWO_SIDED|95.0|2.2|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.33|2.20|0.0004
71749539|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|2.68|18.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.98|2.68|<0.0001
71749540|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|6.84||||0.0001|TWO_SIDED|95.0|2.53|18.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.46|2.53|0.0001
71749541|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.04||||0.154|TWO_SIDED|95.0|0.76|5.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.47|0.76|0.1540
71749542|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.84||||0.0065|TWO_SIDED|95.0|1.46|10.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.12|1.46|0.0065
71749543|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0052|TWO_SIDED|95.0|1.5|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.14|1.50|0.0052
71749544|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0064|TWO_SIDED|95.0|1.44|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.39|1.44|0.0064
71781482|NCT03338010|143062447|SUPERIORITY||LS Mean Difference|-1.67||||0.205|TWO_SIDED|95.0|-4.26|0.92|||Mixed Models Analysis|||ITSQ Overall Total||0.92|-4.26|0.205
71781483|NCT03338010|143062448|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.639
71781484|NCT03338010|143062449|SUPERIORITY||Relative Ratio|1.19||||0.143|TWO_SIDED|95.0|0.74|1.92|||Wilcoxon (Mann-Whitney)|||||1.92|0.74|0.143
71781485|NCT03338010|143062449|SUPERIORITY||Relative Ratio|1.22||||0.945|TWO_SIDED|95.0|0.67|2.23|||Wilcoxon (Mann-Whitney)|||||2.23|0.67|0.945
71813082|NCT01337986|143128520|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.01||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null hypothesis: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity with dalfampridine vs placebo.||||.64
71749545|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0003|TWO_SIDED|95.0|2.26|15.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.21|2.26|0.0003
71749546|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0001|TWO_SIDED|95.0|2.47|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.69|2.47|0.0001
71749547|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|8.21|||<|0.0001|TWO_SIDED|95.0|3.01|22.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||22.42|3.01|<0.0001
71749548|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0171|TWO_SIDED|95.0|1.22|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.97|1.22|0.0171
71749549|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.38||||0.002|TWO_SIDED|95.0|1.71|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.18|1.71|0.0020
71891533|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.087|STANDARD_ERROR_OF_MEAN|0.027||0.0013|TWO_SIDED|95.0|0.034|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.139|0.034|0.0013
71668203|NCT02028676|142852929|SUPERIORITY_OR_OTHER|||||||0.04|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.04
71749550|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0034|TWO_SIDED|95.0|1.58|9.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.99|1.58|0.0034
71749551|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0399|TWO_SIDED|95.0|1.05|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.59|1.05|0.0399
71749552|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0003|TWO_SIDED|95.0|2.23|14.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.84|2.23|0.0003
71749553|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.05||||0.0031|TWO_SIDED|95.0|1.6|10.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.23|1.60|0.0031
71749554|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.41|28.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.28|3.41|<0.0001
71749555|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0036|TWO_SIDED|95.0|1.57|10.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.01|1.57|0.0036
71749556|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.79||||0.0009|TWO_SIDED|95.0|1.89|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.11|1.89|0.0009
71749557|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0091|TWO_SIDED|95.0|1.35|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.21|1.35|0.0091
71749558|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2043|TWO_SIDED|95.0|0.73|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.34|0.73|0.2043
71749559|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0012|TWO_SIDED|95.0|1.84|12.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.01|1.84|0.0012
71749560|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0058|TWO_SIDED|95.0|1.47|9.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.70|1.47|0.0058
71749561|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|8.07||||0.0002|TWO_SIDED|95.0|2.73|23.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||23.83|2.73|0.0002
71749562|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0221|TWO_SIDED|95.0|1.16|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.12|1.16|0.0221
71749563|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0034|TWO_SIDED|95.0|1.58|10.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.13|1.58|0.0034
71749564|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0123|TWO_SIDED|95.0|1.29|8.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.04|1.29|0.0123
71891534|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.118|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.223|0.118|<0.0001
71668204|NCT02028676|142852929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.16||||0.017|TWO_SIDED|95.0|1.15|4.08|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||4.08|1.15|0.017
71749565|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.56||||0.3291|TWO_SIDED|95.0|0.64|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.78|0.64|0.3291
71749566|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0118|TWO_SIDED|95.0|1.3|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.21|1.30|0.0118
71749567|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.93||||0.0058|TWO_SIDED|95.0|1.49|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.40|1.49|0.0058
71749568|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.98||||0.0012|TWO_SIDED|95.0|2.03|17.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||17.65|2.03|0.0012
71749569|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1043|TWO_SIDED|95.0|0.85|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.32|0.85|0.1043
71749570|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0015|TWO_SIDED|95.0|1.85|13.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||13.54|1.85|0.0015
71749571|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0658|TWO_SIDED|95.0|0.95|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.73|0.95|0.0658
71749572|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1253|TWO_SIDED|95.0|0.82|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.98|0.82|0.1253
71749573|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.01||||0.0013|TWO_SIDED|95.0|1.88|13.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.34|1.88|0.0013
71749574|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0096|TWO_SIDED|95.0|1.37|9.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.75|1.37|0.0096
71749575|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|6.06||||0.0012|TWO_SIDED|95.0|2.04|17.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||17.96|2.04|0.0012
71749576|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0344|TWO_SIDED|95.0|1.08|7.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.02|1.08|0.0344
71891535|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.027||0.0001|TWO_SIDED|95.0|0.049|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.154|0.049|0.0001
71891536|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.027||0.0002|TWO_SIDED|95.0|0.048|0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.153|0.048|0.0002
71749577|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0045|TWO_SIDED|95.0|1.55|10.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.72|1.55|0.0045
71781486|NCT02465515|143062461|NON_INFERIORITY|Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p \<0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3)|Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.68|0.9||One-sided p-value based on Wald test of hazard ratio (HR) \>=1.3 versus HR \<1.3.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||0.90|0.68|<0.0001
71781487|NCT02465515|143062461|SUPERIORITY||||||<|0.001||||||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test|||||||<0.001
71781488|NCT02465515|143062462|OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.69|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.69|<0.001
71749578|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.24||||0.081|TWO_SIDED|95.0|0.91|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.55|0.91|0.0810
71749579|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.29||||0.0761|TWO_SIDED|95.0|0.92|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.70|0.92|0.0761
71749580|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0078|TWO_SIDED|95.0|1.41|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.51|1.41|0.0078
71749581|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0253|TWO_SIDED|95.0|1.15|7.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.82|1.15|0.0253
71749582|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|6.23||||0.0017|TWO_SIDED|95.0|1.99|19.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.55|1.99|0.0017
71749583|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3512|TWO_SIDED|95.0|0.62|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.87|0.62|0.3512
71749584|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0352|TWO_SIDED|95.0|1.07|7.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.13|1.07|0.0352
71749585|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.36||||0.0704|TWO_SIDED|95.0|0.93|5.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.97|0.93|0.0704
71749586|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.94||||0.1651|TWO_SIDED|95.0|0.76|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.76|0.1651
71749587|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0964|TWO_SIDED|95.0|0.87|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.62|0.87|0.0964
71749588|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0276|TWO_SIDED|95.0|1.13|8.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.59|1.13|0.0276
71749589|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.99||||0.006|TWO_SIDED|95.0|1.58|15.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.70|1.58|0.0060
71749590|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1556|TWO_SIDED|95.0|0.76|5.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.39|0.76|0.1556
71835305|NCT03897686|143175377|SUPERIORITY||LS-means difference|-14.5|STANDARD_ERROR_OF_MEAN|5.29||0.00693|TWO_SIDED|95.0|-24.95|-4.04||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in stiffness WOMAC score, visit 4||-4.04|-24.95|0.00693
71749591|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.33||||0.0202|TWO_SIDED|95.0|1.21|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.18|1.21|0.0202
71749592|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2063|TWO_SIDED|95.0|0.72|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.67|0.72|0.2063
71749593|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0383|TWO_SIDED|95.0|1.06|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.92|1.06|0.0383
71781489|NCT02465515|143062463|OTHER||Hazard Ratio (HR)|0.93||||0.578|TWO_SIDED|95.0|0.73|1.19||Two-sided p-value based on the Wald statistic|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate|||1.19|0.73|0.578
71781490|NCT02465515|143062464|OTHER||Hazard Ratio (HR)|0.75||||0.003|TWO_SIDED|95.0|0.61|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.90|0.61|0.003
71781491|NCT02465515|143062465|OTHER||Hazard Ratio (HR)|0.86||||0.3|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.14|0.66|0.300
71891537|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.027||0.6093|TWO_SIDED|95.0|-0.066|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.039|-0.066|0.6093
71891538|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.035|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.140|0.035|0.0011
71891539|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.0095|TWO_SIDED|95.0|0.017|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.123|0.017|0.0095
71891540|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.027||0.0108|TWO_SIDED|95.0|0.016|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.121|0.016|0.0108
71668205|NCT02028676|142852929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.034|TWO_SIDED|95.0|1.05|3.8|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||3.80|1.05|0.034
71781492|NCT02465515|143062466|OTHER||Hazard Ratio (HR)|0.85||||0.113|TWO_SIDED|95.0|0.7|1.04||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.04|0.70|0.113
71781493|NCT02465515|143062467|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.33|0.53||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.53|0.33|<0.001
71781494|NCT02465515|143062468|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.043|TWO_SIDED|95.0|0.51|0.99||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||0.99|0.51|0.043
71781495|NCT02465515|143062469|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 8||||||<0.001
71781496|NCT02465515|143062469|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 16||||||<0.001
71781497|NCT02465515|143062469|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 24||||||<0.001
71781498|NCT02465515|143062469|OTHER||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (\<8.0% versus \>= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Final assessment||||||<0.001
71781499|NCT02465515|143062470|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.055|TWO_SIDED|95.0|0.43|1.01||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.01|0.43|0.055
71668206|NCT02028676|142852930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.04|TWO_SIDED|95.0|1.02|1.66|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.66|1.02|0.04
71781500|NCT02465515|143062471|OTHER||Mean Difference (Net)|-0.63|||<|0.001|TWO_SIDED|95.0|-0.69|-0.58||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.58|-0.69|<0.001
71749594|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0118|TWO_SIDED|95.0|1.32|9.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.10|1.32|0.0118
71668207|NCT02028676|142852930|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.53
71749595|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0314|TWO_SIDED|95.0|1.1|7.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.97|1.10|0.0314
71749596|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|6.8||||0.001|TWO_SIDED|95.0|2.17|21.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.34|2.17|0.0010
71749597|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.24||||0.0956|TWO_SIDED|95.0|0.87|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.80|0.87|0.0956
71749598|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0027|TWO_SIDED|95.0|1.72|13.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.40|1.72|0.0027
71749599|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.41||||0.066|TWO_SIDED|95.0|0.94|6.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.14|0.94|0.0660
71749600|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.32||||0.0853|TWO_SIDED|95.0|0.89|6.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.05|0.89|0.0853
71749601|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0159|TWO_SIDED|95.0|1.26|9.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.62|1.26|0.0159
71749602|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0303|TWO_SIDED|95.0|1.12|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.53|1.12|0.0303
71749603|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.84||||0.0071|TWO_SIDED|95.0|1.54|15.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||15.28|1.54|0.0071
71749604|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0621|TWO_SIDED|95.0|0.95|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.95|0.0621
71891541|NCT01431287|143304568|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.027||0.9627|TWO_SIDED|95.0|-0.051|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors|||0.054|-0.051|0.9627
71891542|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.162|0.074|<0.0001
71891543|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.169|0.077|<0.0001
71891544|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.114|0.028|0.0012
71891545|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.137|0.050|<0.0001
71891546|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.121|0.031|0.0010
71668208|NCT02028676|142852930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.68|1.25|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||1.25|0.68|0.60
71891547|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|0.003|0.0384
71891548|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.185|0.097|<0.0001
71668209|NCT02028676|142852930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.56|TWO_SIDED|95.0|0.81|1.46|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||1.46|0.81|0.56
71668210|NCT02028676|142852931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.84|TWO_SIDED|95.0|0.58|1.56|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM|||1.56|0.58|0.84
71668211|NCT02028676|142852931|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors||||||0.002
71668212|NCT02028676|142852931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.001|TWO_SIDED|95.0|1.74|8.29|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A|||8.29|1.74|0.001
71668213|NCT02028676|142852931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.09||||0.006|TWO_SIDED|95.0|1.39|6.85|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A|||6.85|1.39|0.006
71668214|NCT02028676|142852932|SUPERIORITY_OR_OTHER|||||||0.53|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.53
71668215|NCT02028676|142852932|SUPERIORITY_OR_OTHER|||||||0.46|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.46
71668216|NCT02028676|142852933|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.3||||0.52|TWO_SIDED|95.0|-9.3|4.7|||Chi-squared|||||4.7|-9.3|0.52
71668217|NCT02028676|142852934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.39|TWO_SIDED|95.0|-1.2|0.5|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.5|-1.2|0.39
71668218|NCT02028676|142852935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.9|0.9|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.9|-0.9|0.98
71749605|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0081|TWO_SIDED|95.0|1.45|12.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.15|1.45|0.0081
71668219|NCT02028676|142852936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||0.2|-1.9|0.12
71668220|NCT02028676|142852937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.82|TWO_SIDED|95.0|-60.0|76.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||76|-60|0.82
71668221|NCT02028676|142852938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.0||||0.36|TWO_SIDED|95.0|-104.0|38.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||38|-104|0.36
71668222|NCT02028676|142852939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.0||||0.2|TWO_SIDED|95.0|-220.0|46.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily|||46|-220|0.20
71668223|NCT02028676|142852941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.2|TWO_SIDED|95.0|0.11|1.64|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.64|0.11|0.20
71668224|NCT02028676|142852942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Log Rank||Hazard ratio is once-daily vs twice-daily|||1.77|0.31|0.51
71749606|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0533|TWO_SIDED|95.0|0.99|7.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.09|0.99|0.0533
71668225|NCT02028676|142852943|SUPERIORITY_OR_OTHER|||||||0.16|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.16
71668226|NCT02028676|142852944|SUPERIORITY_OR_OTHER|||||||0.54|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.54
71668227|NCT02028676|142852945|SUPERIORITY_OR_OTHER|||||||0.08|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.08
71749607|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.71||||0.2666|TWO_SIDED|95.0|0.66|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.42|0.66|0.2666
71749608|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0754|TWO_SIDED|95.0|0.91|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.52|0.91|0.0754
71749609|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.27||||0.0313|TWO_SIDED|95.0|1.11|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.64|1.11|0.0313
71668228|NCT02028676|142852946|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.82|TWO_SIDED|95.0|0.72|1.52|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.52|0.72|0.82
71668229|NCT02028676|142852947|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.31|TWO_SIDED|95.0|0.48|1.27|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily|||1.27|0.48|0.31
71668230|NCT02028676|142852948|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
71668231|NCT02028676|142852949|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
71668232|NCT02028676|142852950|SUPERIORITY_OR_OTHER|||||||0.93|||||||Generalized estimating equations|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.93
71668233|NCT02028676|142852951|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.21|||<|0.001|TWO_SIDED|95.0|1.5|3.25|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.25|1.50|<0.001
71668234|NCT02028676|142852952|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.44|TWO_SIDED|95.0|0.56|3.85|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||3.85|0.56|0.44
71668235|NCT02028676|142852953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.4||||0.03|TWO_SIDED|95.0|1.05|5.48|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||5.48|1.05|0.03
71668236|NCT02028676|142852954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.98||||0.18|TWO_SIDED|95.0|0.44|35.7|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||35.7|0.44|0.18
71668237|NCT02028676|142852955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.34|TWO_SIDED|95.0|0.53|6.17|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||6.17|0.53|0.34
71668238|NCT02028676|142852956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.68|TWO_SIDED|95.0|0.12|4.15|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||4.15|0.12|0.68
71668239|NCT02028676|142852957|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.07
71668240|NCT02028676|142852958|SUPERIORITY_OR_OTHER|||||||0.19|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.19
71668241|NCT02028676|142852959|SUPERIORITY_OR_OTHER|||||||0.34|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.34
71668242|NCT02028676|142852960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.13|TWO_SIDED|95.0|-1.4|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||0.2|-1.4|0.13
71749610|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|5.76||||0.0056|TWO_SIDED|95.0|1.67|19.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||19.88|1.67|0.0056
71749611|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0736|TWO_SIDED|95.0|0.91|7.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.28|0.91|0.0736
71749612|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0184|TWO_SIDED|95.0|1.24|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||10.00|1.24|0.0184
71668243|NCT02028676|142852961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.68|TWO_SIDED|95.0|-65.0|42.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue|||42|-65|0.68
71668244|NCT02028676|142852962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.04|TWO_SIDED|95.0|1.02|2.5|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue|||2.50|1.02|0.04
71749613|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1187|TWO_SIDED|95.0|0.82|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.81|0.82|0.1187
71749614|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0299|TWO_SIDED|95.0|1.14|12.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.69|1.14|0.0299
71749615|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5989|TWO_SIDED|95.0|0.4|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.89|0.40|0.5989
71668245|NCT02028676|142852963|SUPERIORITY_OR_OTHER|||||||0.21||||||Adjusted for randomization stratification factors|Generalised estimating equation|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks||||||0.21
71668246|NCT00141778|142852995|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Chi-squared|||Discrete variables were compared among treatment groups with a chi-square test.||||0.95
71668247|NCT00141778|142852996|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
71668248|NCT00141778|142852997|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
71668249|NCT00141778|142852998|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
71668250|NCT00141778|142852999|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Kruskal-Wallis|||||||0.56
71668251|NCT00141778|142853000|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||||||0.15
71668252|NCT00141778|142853001|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Chi-squared|||||||0.38
71668253|NCT00141778|142853002|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Chi-squared|||||||0.65
71668254|NCT02729909|142853006|SUPERIORITY||Median Value of confidence interval (CI)|1.0||||0.02|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||||1.9|0.1|0.020
71668255|NCT02729909|142853007|SUPERIORITY||Median Value of CI|1.0||||0.051|TWO_SIDED|95.0|0.0|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||1.9|0.0|0.051
71668256|NCT02729909|142853007|SUPERIORITY||Median Value of CI|1.5||||0.003|TWO_SIDED|95.0|1.0|2.0||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||2.0|1.0|0.003
71749616|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1337|TWO_SIDED|95.0|0.74|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.14|0.74|0.1337
71749617|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4605|TWO_SIDED|95.0|0.45|5.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.89|0.45|0.4605
71749618|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0188|TWO_SIDED|95.0|1.28|15.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||15.65|1.28|0.0188
71749619|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5854|TWO_SIDED|95.0|0.39|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.39|0.5854
71749620|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1768|TWO_SIDED|95.0|0.68|7.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.86|0.68|0.1768
71749621|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8426|TWO_SIDED|95.0|0.29|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.78|0.29|0.8426
71749622|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3017|TWO_SIDED|95.0|0.17|1.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.73|0.17|0.3017
71749623|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5958|TWO_SIDED|95.0|0.21|2.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.43|0.21|0.5958
71749624|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.23||||0.0515|TWO_SIDED|95.0|0.05|1.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.01|0.05|0.0515
71749625|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9734|TWO_SIDED|95.0|0.31|3.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.11|0.31|0.9734
71749626|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.85||||0.7969|TWO_SIDED|95.0|0.25|2.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.93|0.25|0.7969
71749627|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.78||||0.6637|TWO_SIDED|95.0|0.25|2.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.40|0.25|0.6637
71749628|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.53||||0.4921|TWO_SIDED|95.0|0.45|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.15|0.45|0.4921
71749629|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.09||||0.891|TWO_SIDED|95.0|0.33|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.64|0.33|0.8910
71749630|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5881|TWO_SIDED|95.0|0.16|2.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.78|0.16|0.5881
71749631|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.11||||0.0523|TWO_SIDED|95.0|0.01|1.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.02|0.01|0.0523
71749632|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4646|TWO_SIDED|95.0|0.46|5.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.61|0.46|0.4646
71749633|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5806|TWO_SIDED|95.0|0.4|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.14|0.40|0.5806
71668257|NCT02729909|142853007|SUPERIORITY||Median Value of CI|1.0||||0.009|TWO_SIDED|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||1.9|0.1|0.009
71781501|NCT02465515|143062471|OTHER||Mean Difference (Net)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.58|-0.45||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.45|-0.58|<0.001
71781502|NCT02465515|143062472|OTHER||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.83|-0.49||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||-0.49|-0.83|<0.001
71781503|NCT02465515|143062472|OTHER||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.06|-0.6||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||-0.60|-1.06|<0.001
71781504|NCT02465515|143062473|OTHER||Mean Difference (Net)|2.39|||<|0.001|TWO_SIDED|95.0|1.85|2.93||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8|||2.93|1.85|<0.001
71668258|NCT02729909|142853008|SUPERIORITY||Odds Ratio (OR)|2.08||||0.009|TWO_SIDED|95.0|1.19|3.62||The proportion of participants with an SBM within 24 hours after first dose in Week 1 is analyzed by a Cochran-Mantel-Haenszel (CMH) test stratified by center. Centers with less participants were pooled based on geographical proximity.|Cochran-Mantel-Haenszel|||||3.62|1.19|0.009
71668259|NCT02729909|142853009|SUPERIORITY||Median Value of CI|-0.4||||0.001|TWO_SIDED|95.0|-0.6|-0.2||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.2|-0.6|0.001
71668260|NCT02729909|142853009|SUPERIORITY||Median Value of CI|-0.3||||0.004|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||-0.1|-0.5|0.004
71781505|NCT02465515|143062473|OTHER||Mean Difference (Net)|2.33|||<|0.001|TWO_SIDED|95.0|1.66|3.01||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16|||3.01|1.66|<0.001
71781506|NCT02465515|143062474|OTHER||Mean Difference (Net)|1.47|||<|0.001|TWO_SIDED|95.0|0.87|2.07||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||2.07|0.87|<0.001
71781507|NCT02465515|143062474|OTHER||Mean Difference (Net)|0.52||||0.192|TWO_SIDED|95.0|-0.26|1.31||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16|||1.31|-0.26|0.192
71781508|NCT02465515|143062475|OTHER||Hazard Ratio (HR)|0.95||||0.644|TWO_SIDED|95.0|0.79|1.16||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.|||1.16|0.79|0.644
71781509|NCT02465515|143062479|OTHER||Mean Difference (Net)|-1.11||||0.003|TWO_SIDED|95.0|-1.84|-0.39||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.|||-0.39|-1.84|0.003
71781510|NCT02465515|143062479|OTHER||Mean Difference (Net)|-0.43||||0.315|TWO_SIDED|95.0|-1.26|0.41||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16.|||0.41|-1.26|0.315
71781511|NCT00293033|143062482|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.31|16.18|||Mixed Models Analysis|The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.|Onsolis minus placebo|||16.18|3.31|0.004
71781512|NCT00293033|143062483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.44|TWO_SIDED|95.0|-0.4|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|-0.40|0.440
71781513|NCT00293033|143062484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.7||0.179|TWO_SIDED|95.0|-0.44|2.33|||Mixed Models Analysis|||||2.33|-0.44|0.179
71668261|NCT02729909|142853009|SUPERIORITY||Median Value of CI|-0.2||||0.024|TWO_SIDED|95.0|-0.4|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.4|0.024
71668262|NCT02729909|142853009|SUPERIORITY||Median Value of CI|-0.3||||0.01|TWO_SIDED|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.5|0.010
71668263|NCT02729909|142853010|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|1.0||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||1.0|0.4|<0.001
71668264|NCT02729909|142853010|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.9||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||0.9|0.4|<0.001
71749634|NCT03192176|143005306|SUPERIORITY||Odds Ratio (OR)|0.94||||0.922|TWO_SIDED|95.0|0.28|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.12|0.28|0.9220
71749635|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.45||||0.1933|TWO_SIDED|95.0|0.47|42.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||42.25|0.47|0.1933
71749636|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.61||||0.124|TWO_SIDED|95.0|0.62|50.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||50.44|0.62|0.1240
71749637|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|14.16||||0.014|TWO_SIDED|95.0|1.71|117.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||117.2|1.71|0.0140
71749638|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|17.5||||0.0075|TWO_SIDED|95.0|2.15|142.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||142.7|2.15|0.0075
71749639|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.98||||0.5853|TWO_SIDED|95.0|0.17|22.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||22.96|0.17|0.5853
71749640|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.0||||0.1596|TWO_SIDED|95.0|0.53|47.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||47.05|0.53|0.1596
71749641|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.48||||0.0908|TWO_SIDED|95.0|0.74|56.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||56.51|0.74|0.0908
71749642|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.97||||0.1318|TWO_SIDED|95.0|0.72|12.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.19|0.72|0.1318
71749643|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0093|TWO_SIDED|95.0|1.56|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||23.04|1.56|0.0093
71749644|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|10.13||||0.0006|TWO_SIDED|95.0|2.69|38.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||38.22|2.69|0.0006
71749645|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|15.63|||<|0.0001|TWO_SIDED|95.0|4.11|59.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||59.40|4.11|<0.0001
71781514|NCT00293033|143062485|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.16||0.047|TWO_SIDED|95.0|0.04|4.61|||Mixed Models Analysis|||||4.61|0.04|0.047
71781515|NCT00293033|143062486|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.68|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|8.5|30.86|||Mixed Models Analysis|||||30.86|8.50|<0.001
71781516|NCT00293033|143062487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|31.98|STANDARD_ERROR_OF_MEAN|8.23|<|0.001|TWO_SIDED|95.0|15.85|48.12|||Mixed Models Analysis|||||48.12|15.85|<0.001
71781517|NCT00293033|143062488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||||||0.517
71781518|NCT00293033|143062489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
71781519|NCT00293033|143062490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.223|||||||Wilcoxon (Mann-Whitney)|||||||0.223
71781520|NCT00293033|143062491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
71781521|NCT00293033|143062492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71668265|NCT02729909|142853010|SUPERIORITY||Median Value of CI|0.6|||<|0.001|TWO_SIDED|95.0|0.4|0.8||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||0.8|0.4|<0.001
71668266|NCT02729909|142853010|SUPERIORITY||Median Value of CI|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||0.7|0.2|<0.001
71668267|NCT02729909|142853011|SUPERIORITY||Median Value of CI|-0.5||||0.02|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1||-0.1|-0.9|0.020
71749646|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.53||||0.2054|TWO_SIDED|95.0|0.6|10.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.64|0.60|0.2054
71749647|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.8||||0.1592|TWO_SIDED|95.0|0.67|11.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.72|0.67|0.1592
71749648|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.31||||0.007|TWO_SIDED|95.0|1.66|24.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||24.07|1.66|0.0070
71749649|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.39||||0.0392|TWO_SIDED|95.0|1.06|10.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.85|1.06|0.0392
71749650|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0096|TWO_SIDED|95.0|1.44|13.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.96|1.44|0.0096
71749651|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|10.11|||<|0.0001|TWO_SIDED|95.0|3.28|31.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||31.16|3.28|<0.0001
71749652|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|11.76|||<|0.0001|TWO_SIDED|95.0|3.75|36.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.90|3.75|<0.0001
71749653|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.11||||0.2217|TWO_SIDED|95.0|0.64|7.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.03|0.64|0.2217
71749654|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0131|TWO_SIDED|95.0|1.36|13.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.38|1.36|0.0131
71749655|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.46|1.76|0.0031
71781522|NCT00293033|143062493|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71781523|NCT00293033|143062494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|||||||Wilcoxon (Mann-Whitney)|||||||0.193
71781524|NCT00293033|143062495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||||||0.113
71781525|NCT00293033|143062496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||Wilcoxon (Mann-Whitney)|||||||0.192
71781526|NCT00293033|143062497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781527|NCT00293033|143062498|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781528|NCT00293033|143062499|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71781529|NCT00293033|143062500|SUPERIORITY_OR_OTHER_LEGACY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||||||0.157
71781530|NCT00293033|143062501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
71781531|NCT00293033|143062502|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
71781532|NCT00293033|143062503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781533|NCT00293033|143062504|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71781534|NCT00293033|143062505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71781535|NCT00293033|143062506|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71781536|NCT00293033|143062507|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71781537|NCT00293033|143062508|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71781538|NCT00293033|143062509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563|||||||Wilcoxon (Mann-Whitney)|||||||0.563
71781539|NCT00293033|143062510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.498|||||||Wilcoxon (Mann-Whitney)|||||||0.498
71781540|NCT00293033|143062511|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
71781541|NCT00293033|143062512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
71781542|NCT00293033|143062513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.963|||||||Wilcoxon (Mann-Whitney)|||||||0.963
71781543|NCT00293033|143062514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71668268|NCT02729909|142853011|SUPERIORITY|||||||0.072||||||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2||||0.072
71781544|NCT00293033|143062515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71749656|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1485|TWO_SIDED|95.0|0.76|6.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.10|0.76|0.1485
71749657|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0128|TWO_SIDED|95.0|1.31|9.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.56|1.31|0.0128
71749658|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.5||||0.0003|TWO_SIDED|95.0|2.37|17.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.81|2.37|0.0003
71749659|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.32|17.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||17.77|2.32|0.0003
71749660|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.87||||0.2354|TWO_SIDED|95.0|0.67|5.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.26|0.67|0.2354
71749661|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0894|TWO_SIDED|95.0|0.87|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.65|0.87|0.0894
71749662|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0201|TWO_SIDED|95.0|1.2|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.67|1.20|0.0201
71749663|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1614|TWO_SIDED|95.0|0.74|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.94|0.74|0.1614
71749664|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0123|TWO_SIDED|95.0|1.32|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.66|1.32|0.0123
71749665|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.08||||0.0006|TWO_SIDED|95.0|2.17|17.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.03|2.17|0.0006
71781545|NCT00293033|143062516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71781546|NCT00293033|143062517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
71781547|NCT00293033|143062518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71781548|NCT00293033|143062519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71781549|NCT00293033|143062520|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71781550|NCT00293033|143062521|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71749666|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|3.4|28.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||28.36|3.40|<0.0001
71781551|NCT00293033|143062522|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71781552|NCT00293033|143062523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.750
71781553|NCT00293033|143062524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71781554|NCT00293033|143062525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
71781555|NCT00293033|143062526|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71781556|NCT00293033|143062527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781557|NCT00293033|143062528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.96|STANDARD_ERROR_OF_MEAN|2.57||0.023|TWO_SIDED|95.0|0.92|11.01|||Mixed Models Analysis|||||11.01|0.92|0.023
71781558|NCT00293033|143062529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.84|STANDARD_ERROR_OF_MEAN|7.25||0.009|TWO_SIDED|95.0|5.63|34.04|||Mixed Models Analysis|||||34.04|5.63|0.009
71781559|NCT00293033|143062530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.26|STANDARD_ERROR_OF_MEAN|12.72||0.012|TWO_SIDED|95.0|8.32|58.2|||Mixed Models Analysis|||||58.20|8.32|0.012
71781560|NCT00293033|143062531|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|46.88|STANDARD_ERROR_OF_MEAN|18.46||0.015|TWO_SIDED|95.0|10.69|83.08|||Mixed Models Analysis|||||83.08|10.69|0.015
71781561|NCT03583697|143062536|SUPERIORITY||Least Square Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.02|0.53||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in least squares (LS) means were obtained from an analysis of covariance model."||0.53|-0.02|
71781562|NCT03583697|143062536|SUPERIORITY||Least Square Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|0.07|0.54||||||"Z-Scores were derived using age-sex specific reference data (means and SDs) for average stature children per the Centers for Disease Control and Prevention.~Participants aged \< 24 months, body length takes precedence over standing height. Participants aged \< 24 months at baseline and \>= 24 months at Week 52, body length takes precedence.~Difference in LS means were obtained from an analysis of covariance model."||0.54|0.07|
71781563|NCT03583697|143062537|SUPERIORITY||Least Square Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|-0.02|1.56||||||Difference in LS means were obtained from an analysis of covariance model.||1.56|-0.02|
71781564|NCT03583697|143062537|SUPERIORITY||Least Square Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.26|1.66||||||Difference in LS means were obtained from an analysis of covariance model.||1.66|0.26|
71781565|NCT03583697|143062538|SUPERIORITY||Least Square Mean Difference (Net)|0.78|||||TWO_SIDED|95.0|0.02|1.54||||||||1.54|0.02|
71781566|NCT03583697|143062538|SUPERIORITY||Least Square Mean Difference (Net)|0.92|||||TWO_SIDED|95.0|0.24|1.59||||||Difference in LS means were obtained from an analysis of covariance model.||1.59|0.24|
71781567|NCT03583697|143062539|SUPERIORITY||Least Square Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.17|0.04||||||Difference in LS means were obtained from an analysis of covariance model.||0.04|-0.17|
71781568|NCT03583697|143062539|SUPERIORITY||Least Square Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.15|0.03||||||Difference in LS means were obtained from an analysis of covariance model.||0.03|-0.15|
71781569|NCT00679432|143062593|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.1393|TWO_SIDED|95.0|-1.8|13.4|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.||13.4|-1.8|0.1393
71781570|NCT00679432|143062593|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|10.4||||0.0143|TWO_SIDED|95.0|2.2|18.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||18.7|2.2|0.0143
71781571|NCT00679432|143062593|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.7||||0.22|TWO_SIDED|95.0|-2.7|12.1|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.1|-2.7|0.2200
71813083|NCT01337986|143128520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Mixed Models Analysis|||Null hypothesis for period effect: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity for those who started on dalfampridine and crossed over to placebo, compared to those who started on placebo and crossed over to dalfampridine.||||0.11
71668269|NCT02729909|142853011|SUPERIORITY||Median Value of CI|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3||-0.1|-0.9|<0.001
71813084|NCT01337986|143128521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Regression, Logistic|||||||0.93
71813085|NCT01337986|143128522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Regression, Logistic|||||||.34
71781572|NCT00679432|143062594|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.8||||0.3146|TWO_SIDED|95.0|-5.5|17.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||17.0|-5.5|0.3146
71781573|NCT00679432|143062594|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.142|TWO_SIDED|95.0|-2.8|19.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||19.9|-2.8|0.1420
71781574|NCT00679432|143062594|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|9.1||||0.1189|TWO_SIDED|95.0|-2.3|20.4|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||20.4|-2.3|0.1189
71781575|NCT00679432|143062595|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|0.0||||0.9991|TWO_SIDED|95.0|-11.8|11.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.||11.8|-11.8|0.9991
71781576|NCT00873912|143062597|NON_INFERIORITY_OR_EQUIVALENCE|Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.|rate difference|-1.3|||||TWO_SIDED|95.0|-7.9|1.3|||score statistic|||The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference \< 5 percentage points.||1.3|-7.9|
71781577|NCT01980940|143062610|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|5.09|||||TWO_SIDED|90.0|4.03|6.42|||ANOVA|||The geometric least squares mean ratio (GLSMR) and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||6.42|4.03|
71781578|NCT01980940|143062610|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|7.3|||||TWO_SIDED|90.0|6.05|8.81|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||8.81|6.05|
71781579|NCT01980940|143062610|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.45|||||TWO_SIDED|90.0|0.38|0.55|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.55|0.38|
71781580|NCT01980940|143062610|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.65|||||TWO_SIDED|90.0|0.51|0.83|||ANOVA|||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.83|0.51|
71781581|NCT01980940|143062612|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|9.32|||||TWO_SIDED|90.0|4.77|18.18|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||18.18|4.77|
71813086|NCT01337986|143128524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.04|TWO_SIDED|95.0|1.02|2.1||Probability of being in the lowest quartile for Visual Field Index deficits.|Regression, Logistic||Odds Ratio for Visual Field Index|||2.10|1.02|0.04
71668270|NCT02729909|142853011|SUPERIORITY||Median Value of CI|-0.5||||0.004|TWO_SIDED|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4||-0.1|-0.9|0.004
71749667|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1609|TWO_SIDED|95.0|0.75|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.81|0.75|0.1609
71749668|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.42||||0.093|TWO_SIDED|95.0|0.86|6.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.79|0.86|0.0930
71749669|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0063|TWO_SIDED|95.0|1.48|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.91|1.48|0.0063
71749670|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2621|TWO_SIDED|95.0|0.65|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.74|0.65|0.2621
71749671|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0092|TWO_SIDED|95.0|1.37|9.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.21|1.37|0.0092
71749672|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.69||||0.0007|TWO_SIDED|95.0|2.09|15.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.48|2.09|0.0007
71749673|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.0001|TWO_SIDED|95.0|3.08|25.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||25.43|3.08|<0.0001
71749674|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4259|TWO_SIDED|95.0|0.55|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.08|0.55|0.4259
71749675|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1334|TWO_SIDED|95.0|0.79|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.74|0.79|0.1334
71749676|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.39||||0.012|TWO_SIDED|95.0|1.31|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.77|1.31|0.0120
71749677|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2443|TWO_SIDED|95.0|0.66|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.10|0.66|0.2443
71749678|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0022|TWO_SIDED|95.0|1.73|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.25|1.73|0.0022
71749679|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.6||||0.0004|TWO_SIDED|95.0|2.35|18.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||18.58|2.35|0.0004
71749680|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|12.17|||<|0.0001|TWO_SIDED|95.0|4.05|36.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||36.63|4.05|<0.0001
71749681|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3101|TWO_SIDED|95.0|0.61|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.71|0.61|0.3101
71813087|NCT01337986|143128525|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Regression, Logistic|||||||0.94
71813088|NCT01337986|143128526|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71813089|NCT01337986|143128527|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Regression, Linear|||||||0.72
71813090|NCT00548132|143128529|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|0.24|0.9|||Cochran-Mantel-Haenszel|This was calculated based on the assumption that only 85% of eligible patients will consent to the study.|The standard of care is the numerator and the intervention group is the denominator|The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.||0.90|0.24|0.05
71813091|NCT01355458|143128548|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
71813092|NCT03532308|143128550|SUPERIORITY|||||||0.76||||||This is for the effect of treatment with time, risk stratification and treatment\*time interaction in the model.|Mixed Models Analysis|||||||0.76
71749682|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0116|TWO_SIDED|95.0|1.34|10.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.00|1.34|0.0116
71749683|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0045|TWO_SIDED|95.0|1.56|11.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.05|1.56|0.0045
71749684|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3505|TWO_SIDED|95.0|0.62|3.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.88|0.62|0.3505
71749685|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0739|TWO_SIDED|95.0|0.92|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.62|0.92|0.0739
71749686|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0163|TWO_SIDED|95.0|1.24|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.20|1.24|0.0163
71749687|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0001|TWO_SIDED|95.0|2.81|25.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||25.64|2.81|0.0001
71749688|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8358|TWO_SIDED|95.0|0.35|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||2.35|0.35|0.8358
71749689|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1006|TWO_SIDED|95.0|0.86|5.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.52|0.86|0.1006
71749690|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0484|TWO_SIDED|95.0|1.01|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.34|1.01|0.0484
71749691|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6492|TWO_SIDED|95.0|0.5|3.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.08|0.50|0.6492
71781582|NCT01980940|143062612|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|8.12|||||TWO_SIDED|90.0|6.39|10.32|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||10.32|6.39|
71781583|NCT01980940|143062612|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.47|||||TWO_SIDED|90.0|0.39|0.57|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.57|0.39|
71781584|NCT01980940|143062612|SUPERIORITY_OR_OTHER_LEGACY||Treatment ratio|0.41|||||TWO_SIDED|90.0|0.21|0.79|||ANOVA|||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5\*LLOQ (=0.5 h\*ng/ml).||0.79|0.21|
71781585|NCT01980940|143062613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.3|STANDARD_ERROR_OF_MEAN|21.57||0.2113|TWO_SIDED|90.0|-63.6|8.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||8.9|-63.6|0.2113
71749692|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.74||||0.223|TWO_SIDED|95.0|0.71|4.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.27|0.71|0.2230
71749693|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0126|TWO_SIDED|95.0|1.3|9.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.02|1.30|0.0126
71749694|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.56||||0.0014|TWO_SIDED|95.0|1.94|15.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.98|1.94|0.0014
71749695|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|0.7||||0.4713|TWO_SIDED|95.0|0.27|1.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||1.83|0.27|0.4713
71749696|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.02||||0.1397|TWO_SIDED|95.0|0.79|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.12|0.79|0.1397
71749697|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2272|TWO_SIDED|95.0|0.71|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.34|0.71|0.2272
71749698|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2024|TWO_SIDED|95.0|0.72|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.64|0.72|0.2024
71749699|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.9||||0.1716|TWO_SIDED|95.0|0.76|4.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.79|0.76|0.1716
71749700|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.2||||0.0199|TWO_SIDED|95.0|1.2|8.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.51|1.20|0.0199
71749701|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|8.45||||0.0002|TWO_SIDED|95.0|2.8|25.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.54|2.80|0.0002
71749702|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4243|TWO_SIDED|95.0|0.57|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.77|0.57|0.4243
71677070|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.4||||0.4055|TWO_SIDED|95.0|-8.22|3.35||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.35|-8.22|0.4055
71749703|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.99||||0.1507|TWO_SIDED|95.0|0.78|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.78|0.1507
71749704|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0449|TWO_SIDED|95.0|1.02|6.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.60|1.02|0.0449
71749705|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2759|TWO_SIDED|95.0|0.66|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.24|0.66|0.2759
71749706|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.9||||0.17|TWO_SIDED|95.0|0.76|4.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.78|0.76|0.1700
71749707|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0153|TWO_SIDED|95.0|1.27|9.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.51|1.27|0.0153
71781586|NCT01980940|143062613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|19.66||0.2548|TWO_SIDED|90.0|-55.7|10.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||10.3|-55.7|0.2548
71749708|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|6.04||||0.0009|TWO_SIDED|95.0|2.08|17.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||17.53|2.08|0.0009
71781587|NCT01980940|143062613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4|STANDARD_ERROR_OF_MEAN|19.94||0.288|TWO_SIDED|90.0|-54.9|12.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||12.0|-54.9|0.2880
71781588|NCT01980940|143062613|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|19.52||0.3709|TWO_SIDED|90.0|-50.4|15.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||15.1|-50.4|0.3709
71781589|NCT01980940|143062613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|19.81||0.3883|TWO_SIDED|90.0|-50.5|16.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||16.0|-50.5|0.3883
71781590|NCT01980940|143062614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|9.32||0.1383|TWO_SIDED|90.0|-29.7|1.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||1.6|-29.7|0.1383
71781591|NCT01980940|143062614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.66||0.238|TWO_SIDED|90.0|-24.9|4.2|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.2|-24.9|0.2380
71891549|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.040|-0.049|0.8428
71891550|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.020|-0.065|0.3048
71891551|NCT01431287|143304569|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.063|-0.027|0.4311
71677071|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-17.51||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-17.51|-29.30|<0.0001
71781592|NCT01980940|143062614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|8.53||0.2691|TWO_SIDED|90.0|-23.9|4.8|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||4.8|-23.9|0.2691
71813093|NCT03720938|143128556|SUPERIORITY|A sample size of 26 children per group was needed with the assumption of Cohen's d = 0.8, the alpha error of 0.05 and a power of 80%.||||||0.001||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.001
71813094|NCT03720938|143128556|OTHER|||||||0.0002535||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.0002535
71813095|NCT03720938|143128556|SUPERIORITY|||||||0.000397||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.||||0.000397
71813096|NCT03720938|143128557|SUPERIORITY|||||||0.005||||||The outcome of weight z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z scores.||||0.005
71813097|NCT03720938|143128557|SUPERIORITY|||||||0.002||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z score.||||0.002
71813098|NCT03720938|143128557|SUPERIORITY|||||||0.00386||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality. Adjusted by Satterthwaite's degrees of freedom correction method for cluster effect, and small sample sizes in addition to baseline value and age.||||0.00386
71781593|NCT01980940|143062614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.15||0.3246|TWO_SIDED|90.0|-21.8|5.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||5.6|-21.8|0.3246
71781594|NCT01980940|143062614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.19||0.3881|TWO_SIDED|90.0|-20.9|6.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||6.6|-20.9|0.3881
71781595|NCT01980940|143062615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.3|STANDARD_ERROR_OF_MEAN|68.25||0.4477|TWO_SIDED|90.0|-166.8|62.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.3|-166.8|0.4477
71781596|NCT01980940|143062615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.7|STANDARD_ERROR_OF_MEAN|65.42||0.6084|TWO_SIDED|90.0|-143.6|76.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||76.1|-143.6|0.6084
71781597|NCT01980940|143062615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.2|STANDARD_ERROR_OF_MEAN|65.25||0.5926|TWO_SIDED|90.0|-144.7|74.4|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||74.4|-144.7|0.5926
71781598|NCT01980940|143062615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|62.49||0.5022|TWO_SIDED|90.0|-147.2|62.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||62.6|-147.2|0.5022
71781599|NCT01980940|143062615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.0|STANDARD_ERROR_OF_MEAN|63.7||0.5125|TWO_SIDED|90.0|-149.0|64.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo \[Pt 2\]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.||64.9|-149.0|0.5125
71781600|NCT01980940|143062616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2632|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 2 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.2632
71781601|NCT01980940|143062616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4703|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 4 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.4703
71781602|NCT01980940|143062616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 7 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.5507
71781603|NCT01980940|143062616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3992|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 11 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3992
71781604|NCT01980940|143062616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6626|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 14 PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.6626
71781605|NCT01980940|143062616|SUPERIORITY_OR_OTHER_LEGACY|||||||0.315|||||||Jonckheere-Terpstra test|||Treatment comparison of post-trial PGART frequencies (ETOR 50 DMSO vs Placebo \[Pt 2\]) was performed using a two-sided Jonckheere-Terpstra test.||||0.3150
71781606|NCT05263895|143062625|OTHER||Ratio of Adjusted Geometric means|90.54|||||TWO_SIDED|90.0|79.85|102.65||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||102.65|79.85|
71835306|NCT03897686|143175377|SUPERIORITY||LS-means difference|-16.18|STANDARD_ERROR_OF_MEAN|4.68||0.00073|TWO_SIDED|95.0|-25.44|-6.92||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in pain WOMAC score at visit 5 (week 25)||-6.92|-25.44|0.00073
71781607|NCT05263895|143062625|OTHER||Ratio of Adjusted Geometric Means|102.78|||||TWO_SIDED|90.0|90.65|116.53||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.53|90.65|
71781608|NCT05263895|143062625|OTHER||Ratio of Adjusted Geometric Means|138.15|||||TWO_SIDED|90.0|118.03|161.69||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||161.69|118.03|
71835307|NCT03897686|143175377|SUPERIORITY||LS-means difference|-57.14|STANDARD_ERROR_OF_MEAN|32.1||0.07725|TWO_SIDED|95.0|-120.62|6.33||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 3||6.33|-120.62|0.07725
71749709|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6228|TWO_SIDED|95.0|0.5|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.23|0.50|0.6228
71749710|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.62||||0.046|TWO_SIDED|95.0|1.02|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.76|1.02|0.0460
71749711|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1215|TWO_SIDED|95.0|0.82|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.23|0.82|0.1215
71749712|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.75||||0.247|TWO_SIDED|95.0|0.68|4.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.48|0.68|0.2470
71749713|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2072|TWO_SIDED|95.0|0.72|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.66|0.72|0.2072
71749714|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0621|TWO_SIDED|95.0|0.95|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.95|0.0621
71749715|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|5.67||||0.0016|TWO_SIDED|95.0|1.93|16.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.69|1.93|0.0016
71749716|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4372|TWO_SIDED|95.0|0.56|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.84|0.56|0.4372
71749717|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.18||||0.11|TWO_SIDED|95.0|0.84|5.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.66|0.84|0.1100
71749718|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0533|TWO_SIDED|95.0|0.99|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.59|0.99|0.0533
71781609|NCT05263895|143062625|OTHER||Ratio of Adjusted Geometric Means|30.8|||||TWO_SIDED|90.0|25.7|35.2||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||35.20|25.70|
71781610|NCT05263895|143062626|OTHER||Ratio of Adjusted Geometric Means|91.26|||||TWO_SIDED|90.0|80.46|103.51||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||103.51|80.46|
71835308|NCT03897686|143175377|SUPERIORITY||LS-means difference|-103.27|STANDARD_ERROR_OF_MEAN|33.92||0.00279|TWO_SIDED|95.0|-170.35|-36.2||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 4||-36.20|-170.35|0.00279
71891552|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.139|0.057|<0.0001
71781611|NCT05263895|143062626|OTHER||Ratio of Adjusted Geometric Means|102.49|||||TWO_SIDED|90.0|90.36|116.26||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||116.26|90.36|
71781612|NCT05263895|143062626|OTHER||Ratio of Adjusted Geometric Means|136.99|||||TWO_SIDED|90.0|117.09|160.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||160.27|117.09|
71781613|NCT05263895|143062626|OTHER||Ratio of Adjusted Geometric Means|29.77|||||TWO_SIDED|90.0|25.45|34.83||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||34.83|25.45|
71781614|NCT05263895|143062627|OTHER||Ratio of Adjusted Geometric Means|94.28|||||TWO_SIDED|90.0|80.77|110.05||||||Test: Nirmatrelvir (slower dissolution tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||110.05|80.77|
71781615|NCT05263895|143062627|OTHER||Ratio of Adjusted Geometric Means|108.6|||||TWO_SIDED|90.0|93.04|126.76||||||Test: Nirmatrelvir (large particle size tablets)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||126.76|93.04|
71781616|NCT05263895|143062627|OTHER||Ratio of Adjusted Geometric Means|264.12|||||TWO_SIDED|90.0|232.32|300.27||||||Test: Nirmatrelvir (SDD suspension)/ritonavir 300/100 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||300.27|232.32|
71835309|NCT03897686|143175377|SUPERIORITY||LS-means difference|-133.29|STANDARD_ERROR_OF_MEAN|35.26||0.00023|TWO_SIDED|95.0|-203.03|-63.55||The threshold for statistical significance was p \<0.05.|ANCOVA|"Analysis of covariance (ANCOVA) adjusted for the baseline value with fixed factors of treatment group and radiological stage"||Contrasts for changes in functionality WOMAC score, visit 5||-63.55|-203.03|0.00023
71891553|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.149|0.063|<0.0001
71677072|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.2||||0.068|TWO_SIDED|95.0|-8.82|0.32||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.32|-8.82|0.0680
71749719|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.68||||0.1769|TWO_SIDED|95.0|0.5|44.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||44.00|0.50|0.1769
71749720|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.26||||0.4942|TWO_SIDED|95.0|0.22|23.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||23.53|0.22|0.4942
71749721|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|12.82||||0.0214|TWO_SIDED|95.0|1.46|112.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||112.7|1.46|0.0214
71749722|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.93||||0.6013|TWO_SIDED|95.0|0.16|22.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.99|0.16|0.6013
71749723|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0537|TWO_SIDED|95.0|0.97|76.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||76.58|0.97|0.0537
71749724|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.8||||0.2662|TWO_SIDED|95.0|0.36|39.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||39.91|0.36|0.2662
71749725|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.51||||0.7431|TWO_SIDED|95.0|0.13|17.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||17.84|0.13|0.7431
71749726|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|3.53||||0.2829|TWO_SIDED|95.0|0.35|35.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||35.22|0.35|0.2829
71749727|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|2.12||||0.5311|TWO_SIDED|95.0|0.2|22.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||22.29|0.20|0.5311
71749728|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.71||||0.1857|TWO_SIDED|95.0|0.47|46.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.83|0.47|0.1857
71749729|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9879|TWO_SIDED|95.0|0.06|17.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.50|0.06|0.9879
71749730|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.57||||0.1853|TWO_SIDED|95.0|0.48|43.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||43.19|0.48|0.1853
71749731|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|4.43||||0.217|TWO_SIDED|95.0|0.42|46.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||46.93|0.42|0.2170
71749732|NCT03192176|143005307|SUPERIORITY||Odds Ratio (OR)|0.74||||0.8354|TWO_SIDED|95.0|0.04|12.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||12.62|0.04|0.8354
71749733|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9671|TWO_SIDED|95.0|0.06|16.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.04|0.06|0.9671
71749734|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.16||||0.3289|TWO_SIDED|95.0|0.31|31.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.87|0.31|0.3289
71749735|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.26||||0.3157|TWO_SIDED|95.0|0.32|32.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||32.71|0.32|0.3157
71835310|NCT03897686|143175378|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
71835311|NCT03897686|143175379|SUPERIORITY||||||<|0.005||||||The level of significance was set to p \<0.05.|Chi-squared|P-value generated by Chi-squared test was ≤0.005 for each time point.||The Chi-Square test was used to determine whether there was a statistically significant difference in disposition of results between two groups.||||<0.005
71835312|NCT03897686|143175381|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 3 (week 6).||||0.050
71835313|NCT03897686|143175381|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p \<0.05.|ANCOVA|||The mean number of paracetamol tablets was calculated taking into account only patients who had received paracetamol. ANCOVA was used to detect a difference in means of 2 groups at visit 4 (week 13).||||0.004
71835314|NCT05485922|143175390|SUPERIORITY|Number of flow-stop episodes will be analysed, in a generalized linier mixed model, with subject included as a random component. Evidence of superior effect will be concluded, if the lower 95% confidence limit of the risk ratio between comparator and investigational device, is more than 1.|Risk Ratio (RR)|0.16|||<|0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||||0.44|0.05|<0.05
71835315|NCT05485922|143175391|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.05|TWO_SIDED|95.0|14.69|53.91||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||53.91|14.69|0.05
71835316|NCT05485922|143175392|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.16||||0.05|TWO_SIDED|95.0|0.05|0.44|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.44|0.05|0.05
71835317|NCT05485922|143175393|SUPERIORITY||Mean Difference (Final Values)|-95.69||||0.05|TWO_SIDED|95.0|-137.69|-53.7|||Mixed Models Analysis|||The intra-catheter pressure at flow stop was analysed in a general linear mixed model with subject included as a random component.||-53.70|-137.69|0.05
71668271|NCT02730663|142853020|NON_INFERIORITY|The number and percentage of patients who achieved clinical success at the time of stent removal are presented. A one-sided 97.5% confidence interval is to be calculated to confirm the degree of non-inferiority for the reference value (96%) and the difference (Investigational device - reference value) and if the lower limit of the confidence interval is -10% or higher, the noninferiority will be considered to be confirmed.|Reference value|-0.07||||0.05|ONE_SIDED|97.5||||A two-tail test was performed for statistics at a significance level of 0.05 unless otherwise specified.|t-test, 2 sided|||The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.||||0.05
71668272|NCT01610492|142853040|OTHER||Geometric Mean|0.76|||||TWO_SIDED|95.0|0.57|1.01||||||||1.01|0.57|
71835318|NCT05485922|143175394|OTHER||Mean Difference (Final Values)|1.21||||0.05|TWO_SIDED|95.0|-11.1|13.51|||Mixed Models Analysis|||||13.51|-11.10|0.05
71835319|NCT05485922|143175395|SUPERIORITY||Odds Ratio (OR)|0.26||||0.05|TWO_SIDED|95.0|0.07|0.96|||Mixed Models Analysis|||Analyzed using a generalized linear mixed model, modelling the probability of a positive outcome. Evidence of effect in favour of the MHZC was concluded if the upper 95% confidence limit (CL) of the odds ratio, O.R. was less than 1.||0.96|0.07|0.05
71891554|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.091|0.010|0.0136
71668273|NCT01610492|142853041|OTHER||Geometric Mean|0.27|||||TWO_SIDED|95.0|0.12|0.58||||||||0.58|0.12|
71677073|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-33.2|-23.94||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|Comparison of MPA to 20 uM ADP at 24 hours||-23.94|-33.20|<0.0001
71835320|NCT05767437|143175416|EQUIVALENCE|effect size of 0.02, α \< 0.05, power = 0.02|Mean Difference (Net)|1.63||||0.98|TWO_SIDED|95.0|-55.79|59.05|||Mixed Models Analysis|||||59.05|-55.79|0.98
71835321|NCT05767437|143175417|EQUIVALENCE|an effect size of 0.00, α \< 0.05, power = 0.00|Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.25|1.24|||Mixed Models Analysis|||||1.24|-1.25|0.99
71835322|NCT05767437|143175418|EQUIVALENCE|an effect size of 0.56 , α \< 0.05, power = 32.5|Mean Difference (Net)|6.71||||0.68|TWO_SIDED|95.0|-24.12|10.71|||Mixed Models Analysis|||||10.71|-24.12|0.68
71835323|NCT05767437|143175419|EQUIVALENCE|Analysis population description: patients were randomly assigned to either Group A or Group B|Mean Difference (Net)|0.2||||0.56|TWO_SIDED|95.0|-0.48|0.87|||Mixed Models Analysis|||an effect size of 0.24, α \< 0.05, power = 24.5||0.87|-0.48|0.56
71835324|NCT05767437|143175420|EQUIVALENCE|an effect size of 0.56, α \< 0.05, power = 57.9|Mean Difference (Net)|-250.35||||0.42|TWO_SIDED|95.0|-614.88|114.18||Interaction of Assessment and Group|Mixed Models Analysis|||||114.18|-614.88|0.42
71891555|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.116|0.035|0.0003
71677074|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.96|-9.65||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.65|-19.96|<0.0001
71749736|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.0||||0.991|TWO_SIDED|95.0|0.06|16.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.83|0.06|0.991
71749737|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.26||||0.5139|TWO_SIDED|95.0|0.2|26.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||26.12|0.20|0.5139
71749738|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.32||||0.3079|TWO_SIDED|95.0|0.33|33.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||33.45|0.33|0.3079
71749739|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|8.83||||0.0469|TWO_SIDED|95.0|1.03|75.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||75.68|1.03|0.0469
71749740|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|14.39||||0.0134|TWO_SIDED|95.0|1.74|119.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||119.1|1.74|0.0134
71749741|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|4.98||||0.1606|TWO_SIDED|95.0|0.53|46.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||46.90|0.53|0.1606
71749742|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|6.69||||0.0854|TWO_SIDED|95.0|0.77|58.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||58.35|0.77|0.0854
71749743|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|6.07||||0.1082|TWO_SIDED|95.0|0.67|54.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||54.72|0.67|0.1082
71749744|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|7.22||||0.0737|TWO_SIDED|95.0|0.83|63.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||63.04|0.83|0.0737
71749745|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|11.98||||0.0217|TWO_SIDED|95.0|1.44|99.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||99.74|1.44|0.0217
71749746|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|19.24||||0.0058|TWO_SIDED|95.0|2.36|157.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||157.1|2.36|0.0058
71749747|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|4.44||||0.1924|TWO_SIDED|95.0|0.47|41.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||41.87|0.47|0.1924
71749748|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|7.54||||0.068|TWO_SIDED|95.0|0.86|66.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||66.00|0.86|0.0680
71749749|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|15.95||||0.0095|TWO_SIDED|95.0|1.97|129.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||129.4|1.97|0.0095
71749750|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.68||||0.269|TWO_SIDED|95.0|0.36|37.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||37.21|0.36|0.2690
71781617|NCT05263895|143062627|OTHER||Ratio of Adjusted Geometric Means|145.53|||||TWO_SIDED|90.0|128.01|165.45||||||Test: Nirmatrelvir (SDD suspension) 300 mg Reference: Nirmatrelvir (commercial tablets)/ritonavir 300/100 mg||165.45|128.01|
71781618|NCT00844831|143062636|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
71781619|NCT00844831|143062638|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||.9
71813099|NCT03720938|143128558|SUPERIORITY|||||||0||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.000
71835325|NCT05767437|143175421|EQUIVALENCE|an effect size of 0.29, α \< 0.05, power = 88.9|Mean Difference (Net)|12.25||||0.45|TWO_SIDED|95.0|-18.67|43.17|||Mixed Models Analysis|||||43.17|-18.67|0.45
71835326|NCT05767437|143175422|EQUIVALENCE|an effect size of 0.18, α \< 0.05, power =6.5|mean rank (Z)|0.18||||0.67|TWO_SIDED|95.0|-0.61|0.96||MAS of Biceps|Wilcoxon (Mann-Whitney)|||||0.96|-0.61|0.67
71835327|NCT05767437|143175423|EQUIVALENCE|an effect size of 0.39, α \< 0.05, power = 16.2|Mean Difference (Net)|-6.63||||0.38|TWO_SIDED|95.0|-19.38|6.12|||t-test, 2 sided|||||6.12|-19.38|0.38
71749751|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|10.28||||0.0321|TWO_SIDED|95.0|1.22|86.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||86.53|1.22|0.0321
71749752|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|14.48||||0.0131|TWO_SIDED|95.0|1.75|119.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||119.7|1.75|0.0131
71749753|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|25.22||||0.0025|TWO_SIDED|95.0|3.11|204.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||204.6|3.11|0.0025
71749754|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|4.65||||0.1788|TWO_SIDED|95.0|0.49|43.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||43.72|0.49|0.1788
71749755|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|10.33||||0.032|TWO_SIDED|95.0|1.22|87.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||87.31|1.22|0.0320
71749756|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|11.24||||0.0251|TWO_SIDED|95.0|1.35|93.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||93.33|1.35|0.0251
71749757|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.43||||0.6154|TWO_SIDED|95.0|0.35|5.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.83|0.35|0.6154
71749758|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1906|TWO_SIDED|95.0|0.65|8.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.63|0.65|0.1906
71749759|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.67||||0.045|TWO_SIDED|95.0|1.03|13.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.07|1.03|0.0450
71749760|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0017|TWO_SIDED|95.0|2.1|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||24.66|2.10|0.0017
71749761|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.8||||0.3939|TWO_SIDED|95.0|0.47|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.97|0.47|0.3939
71749762|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2869|TWO_SIDED|95.0|0.55|7.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.74|0.55|0.2869
71749763|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1817|TWO_SIDED|95.0|0.66|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.80|0.66|0.1817
71835328|NCT04349072|143175519|SUPERIORITY||Proportion Difference|58.93|||<|0.0001|TWO_SIDED|95.0|43.989|73.868|||Cochran-Mantel-Haenszel|||||73.868|43.989|<0.0001
71835329|NCT04349072|143175520|SUPERIORITY||Proportion Difference|41.07|||<|0.0001|TWO_SIDED|95.0|24.481|57.662|||Cochran-Mantel-Haenszel|||||57.662|24.481|<0.0001
71835330|NCT04349072|143175521|SUPERIORITY||Leat Square Mean of Treatment Difference|9.45|||<|0.0001|TWO_SIDED|95.0|4.868|14.041|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||14.041|4.868|<0.0001
71835331|NCT04349072|143175522|SUPERIORITY||Mean Ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.266|0.421|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.421|0.266|<0.0001
71835332|NCT04349072|143175523|SUPERIORITY||Mean Ratio|0.53|||<|0.0001|TWO_SIDED|95.0|0.406|0.7|||Mixed Models Analysis|Mixed model with repeated measure (MMRM)||||0.700|0.406|<0.0001
71835333|NCT04349072|143175524|SUPERIORITY||Leat Square Mean of Treatment Difference|-37.2|||<|0.0001|TWO_SIDED|95.0|-48.08|-26.24|||ANCOVA|||||-26.24|-48.08|<0.0001
71835334|NCT02713126|143175567|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.770
71835335|NCT02713126|143175568|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
71835336|NCT02713126|143175569|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
71835337|NCT02713126|143175570|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||0.708
71835338|NCT02713126|143175571|SUPERIORITY|||||||0.496|||||||t-test, 2 sided|||||||0.496
71835339|NCT00100698|143175572|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.0|STANDARD_ERROR_OF_MEAN|6.0||0.049|TWO_SIDED|95.0|-38.0|-0.5|||repeated measures mixed effects ANCOVA|||||-0.5|-38|0.049
71835340|NCT04157348|143175596|SUPERIORITY||Difference in remission rates|0.0121||||0.8773|TWO_SIDED|95.0|-0.1411|0.1653|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||0.1653|-0.1411|0.8773
71835341|NCT04157348|143175597|SUPERIORITY||difference in remission rates|0.0544|||||TWO_SIDED|95.0|-0.0746|0.1834|||Regression, Logistic|marginal standardization method||||0.1834|-0.0746|
71835342|NCT04157348|143175598|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.72|2.4|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|main remission||2.40|0.72|
71835343|NCT04157348|143175598|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.55|2.29|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|supportive remission||2.29|0.55|
71835344|NCT04157348|143175599|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.74|2.44|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|sustained main remission||2.44|0.74|
71835345|NCT04157348|143175599|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.64|2.34|||Proportional Odds Model||The odds ratio (Benralizumab vs. Mepolizumab) and its 95% CI are estimated with a proportional odds model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region. A \>1 odds ratio means Benralizumab is favored.|sustained supportive remission||2.34|0.64|
71835346|NCT04157348|143175600|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.53|1.82|||Regression, Cox||The HR (Benralizumab vs. Mepolizumab) and 95% CI are estimated using a Cox regression model with Efron method to control for ties. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.82|0.53|
71835347|NCT04157348|143175601|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.56|1.9|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Mepolizumab) and the corresponding 95% CI are calculated using a negative binomial model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|relapse||1.90|0.56|
71835348|NCT04157348|143175603|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.75|2.54|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||2.54|0.75|
71835349|NCT04157348|143175604|SUPERIORITY||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|0.96|3.22|||proportional odds model||The odds ratio (Benralizumab 30 mg vs. Mepolizumab 300 mg) for higher % reduction and 95% CI are estimated using a proportional odds model. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region.|||3.22|0.96|
71835350|NCT04157348|143175605|SUPERIORITY||difference in proportions|0.1079|||||TWO_SIDED|95.0|-0.0225|0.2383|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|\>=50% reduction||0.2383|-0.0225|
71835351|NCT04157348|143175605|SUPERIORITY||difference in proportions|0.1569|||||TWO_SIDED|95.0|0.0067|0.3017|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|100% reduction||0.3017|0.0067|
71835352|NCT04157348|143175605|SUPERIORITY||difference in proportions|-0.0068|||||TWO_SIDED|95.0|-0.1555|0.1418|||Regression, Logistic|marginal standardization method|The difference of proportions (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|OCS dose \<=4 mg/day||0.1418|-0.1555|
71891556|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.101|0.016|0.0065
71891557|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.089|0.005|0.0277
71891558|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.164|0.081|<0.0001
71891559|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.049|0.7116
71891560|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.016|-0.065|0.2332
71668274|NCT03657797|142853139|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.4||||0.2666|TWO_SIDED|95.0|-1.11|0.31||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 470 0.21% was compared to latanoprost.||0.31|-1.11|0.2666
71781620|NCT02957305|143062639|NON_INFERIORITY|400µg of misoprostol yields a 96% cervical dilation \> 8 mm. We considered 86% of the 200 µg misoprostol group as the minimal acceptable percentage. The non-inferiority margin was determined by 24.46.|treatment difference|25.0||||0.025|ONE_SIDED|95.0||97.5||The null hypothesis: percentage of dilation with 400µg ≥ percentage of dilation with 200µg + 25% Alternative hypothesis: percentage of dilation with 400µg - 25% \< percentage of dilation with 200µg|difference between proportions|difference between percentages and 95% confidence interval||If there is a true difference in favour of the standard treatment of 10% (96% vs 86%), then 184 patients are required to be 95% sure that the upper limit of a one-sided 97.5% confidence interval (or equivalently a 95% two-sided confidence interval) will exclude a difference in favour of the standard group of more than 25%||97.5||0.025
71781621|NCT02957305|143062639|NON_INFERIORITY|The non-inferiority margin was determined by ⅓ of the difference between the 400µg effect (96.7%), compared to the 200 µg dose (23.3%), i.e. 73.4 / 3 = 24.46%|Difference between proportions|0.1146||||0.004|TWO_SIDED|95.0|0.037|0.192|||Chi-squared||The difference between both groups was 11.5% (95%CI = 3.7% to 19.2%)|||0.192|0.037|0.004
71781622|NCT02957305|143062641|SUPERIORITY||Median Difference (Final Values)|0.0||||0.9|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.9
71781623|NCT03486223|143062673|SUPERIORITY|||||||0.71||||||Wilcoxon signed-rank test was used for the within-subject comparison of GSK2256294 versus placebo.|Wilcoxon (Mann-Whitney)|||A sample size of 16 per group was estimated to have 86% power to detect a within-subject difference of 3.76 (80% of the above difference) or larger (with an SD for the within-subject difference of 4.6) in insulin sensitivity.||||0.71
71781624|NCT01749137|143062690|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.059|TWO_SIDED|95.0|-2.27|0.04|||Mixed Model Repeated Measures (MMRM)|||||0.04|-2.27|0.059
71781625|NCT01749137|143062691|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.66||0.079|TWO_SIDED|95.0|-2.48|0.14|||MMRM|||||0.14|-2.48|0.079
71781626|NCT01749137|143062692|SUPERIORITY|||||||0.513||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site and the stratification factor severely obese (yes/no).|Cochran-Mantel-Haenszel|||||||0.513
71781627|NCT01749137|143062700|SUPERIORITY|P-value from a mixed-effects analysis of covariance model with treatment, visit and visit-by-treatment interaction as factors, baseline weight as a covariate, and participant as the random effect.|Treatment Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.87||0.387|TWO_SIDED|95.0|-2.5|0.98|||MMRM|||||0.98|-2.50|0.387
71781628|NCT01749137|143062701|SUPERIORITY|||||||1||||||P-values from a Cochran-Mantel-Haenszel (CMH) test, controlling for site.|Cochran-Mantel-Haenszel|||||||1.000
71781629|NCT01758432|143062702|SUPERIORITY||Least Squares Means (Difference)|-95.74|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781630|NCT01758432|143062702|SUPERIORITY||Least Squares Means (Difference)|-130.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781631|NCT01758432|143062702|SUPERIORITY||Least Squares Means (Difference)|-129.86|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781632|NCT01758432|143062702|SUPERIORITY||Least Squares Means (Difference)|-165.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781633|NCT01758432|143062702|SUPERIORITY||Least Squares Means (Difference)|-167.94|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71677075|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.87|-9.32||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.32|-19.87|<0.0001
71781634|NCT01758432|143062702|SUPERIORITY||Least Squares Means (Difference)|-135.91|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781635|NCT01758432|143062703|SUPERIORITY||Least Squares Means (Difference)|85559.49||||0.0004|TWO_SIDED|95.0|||||ANCOVA|||||||0.0004
71781636|NCT01758432|143062703|SUPERIORITY||Least Squares Means (Difference)|105508.3|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781637|NCT01758432|143062703|SUPERIORITY||Least Squares Means (Difference)|182753.2|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781638|NCT01758432|143062703|SUPERIORITY||Least Squares Means (Difference)|193684.5|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781639|NCT01758432|143062703|SUPERIORITY||Least Squares Means (Difference)|178055.0|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781640|NCT01758432|143062703|SUPERIORITY||Least Squares Means (Difference)|169709.9|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781641|NCT01758432|143062704|SUPERIORITY||Least Squares Means (Difference)|-4.58|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781642|NCT01758432|143062704|SUPERIORITY||Least Squares Means (Difference)|-4.29|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781643|NCT01758432|143062704|SUPERIORITY||Least Squares Means (Difference)|-6.15|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781644|NCT01758432|143062704|SUPERIORITY||Least Squares Means (Difference)|-6.79|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71781645|NCT01758432|143062704|SUPERIORITY||Least Squares Means (Difference)|-7.49|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71668275|NCT03657797|142853139|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-0.81||||0.0281|TWO_SIDED|95.0|-1.52|-0.09||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.042% was compared to latanoprost.||-0.09|-1.52|0.0281
71677076|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.3|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.30|<0.0001
71749764|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|11.41||||0.0256|TWO_SIDED|95.0|1.35|96.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||96.77|1.35|0.0256
71749765|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||112.8|1.65|0.0153
71749766|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|21.76||||0.0042|TWO_SIDED|95.0|2.64|179.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||179.2|2.64|0.0042
71749767|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|35.75||||0.0008|TWO_SIDED|95.0|4.39|291.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||291.5|4.39|0.0008
71749768|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|6.45||||0.0967|TWO_SIDED|95.0|0.71|58.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||58.21|0.71|0.0967
71749769|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0564|TWO_SIDED|95.0|0.94|72.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||72.95|0.94|0.0564
71749770|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|23.63||||0.003|TWO_SIDED|95.0|2.93|190.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||190.5|2.93|0.0030
71749771|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|9.72||||0.0384|TWO_SIDED|95.0|1.13|83.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||83.68|1.13|0.0384
71749772|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|13.65||||0.0153|TWO_SIDED|95.0|1.65|112.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||112.9|1.65|0.0153
71749773|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|30.55||||0.0015|TWO_SIDED|95.0|3.72|250.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||250.6|3.72|0.0015
71749774|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|35.99||||0.0008|TWO_SIDED|95.0|4.41|293.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||293.5|4.41|0.0008
71749775|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|12.67||||0.0192|TWO_SIDED|95.0|1.51|106.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.1|1.51|0.0192
71749776|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|16.92||||0.0089|TWO_SIDED|95.0|2.03|141.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||141.0|2.03|0.0089
71781646|NCT01758432|143062704|SUPERIORITY||Least Squares Means (Difference)|-6.71|||<|0.0001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.0001
71891561|NCT01431287|143304570|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.059|-0.025|0.4374
71781647|NCT02417831|143062711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|105.76|STANDARD_DEVIATION|14.18|||TWO_SIDED|90.0|99.81|112.08|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||112.08|99.81|
71891562|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.244|0.077|0.0002
71749777|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|24.96||||0.0025|TWO_SIDED|95.0|3.09|201.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||201.6|3.09|0.0025
71891563|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.228|0.053|0.0017
71891564|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.210|0.046|0.0022
71891565|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.259|0.093|<0.0001
71781648|NCT02417831|143062712|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.4|STANDARD_DEVIATION|9.05|||TWO_SIDED|90.0|97.71|105.23|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.23|97.71|
71781649|NCT02417831|143062713|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence range of 80% to 125%.|Ratio|101.42|STANDARD_DEVIATION|8.85|||TWO_SIDED|90.0|97.81|105.17|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.|||105.17|97.81|
71781650|NCT01144286|143062725|SUPERIORITY_OR_OTHER||response rate (%)|80.0||||0.063|TWO_SIDED|95.0||||Significance level was set to α of 0.05 if the primary endpoint was significant, hierarchical testing was to be performed on the primary endpoint (each active dose X placebo). No other adjustment was made for testing multiple secondary outcomes.|Regression, Logistic|||"Primary analysis is the dose response at TOC based on the global therapeutic cure. Dose response will be tested using a logistic regression using linear coefficient for the treatment effect(Wald chi-square).~Assuming that the response rate is 80% for 600 mg, 75% for the 300 mg, 65% for 150 mg and 50% for the placebo group, a sample size of 45 subjects in each group will have 90% power to detect a linear dose response using a 0.05 two-sided test of trend based on the logistic model."||||0.0630
71781651|NCT01803204|143062728|SUPERIORITY_OR_OTHER||GEE|1.0||||1|TWO_SIDED|99.0|||||GEE|||||||1.00
71781652|NCT01803204|143062729|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||Mist Effects Model|||||||<0.01
71781653|NCT01803204|143062730|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|99.0|||||Mist Effect Model|||||||0.81
71891566|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.194|0.022|0.0141
71891567|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.118|-0.053|0.4581
71677077|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-20.59|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-9.22|-20.59|<0.0001
71781654|NCT01153347|143062731|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|1.07||1|TWO_SIDED|95.0|-2.96|1.24||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.24|-2.96|1.000
71891568|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.293|0.124|<0.0001
71891569|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.105|-0.064|0.6335
71891570|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.034|-0.129|0.2530
71891571|NCT01431287|143304571|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.153|-0.017|0.1188
71891572|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.217|0.057|0.0008
71891573|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.209|0.042|0.0032
71891574|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.183|0.027|0.0085
71668276|NCT03657797|142853139|NON_INFERIORITY|LS mean, the difference in LS mean (NCX 470 minus latanoprost), and the 2-sided 95% CI for the difference was obtained. Non-inferiority could be claimed if the upper limit of the 2-sided 95% CI around the difference between the LS mean for NCX 470 and the LS mean for latanoprost was \< 1.5 mmHg. If non-inferiority was met, superiority was tested which could be claimed if the p-value for treatment difference was \<= 0.05 and the LS mean difference in change from baseline was \< 0.|Mean Difference (Final Values)|-1.23||||0.0009|TWO_SIDED|95.0|-1.96|-0.51||p-value was not adjusted for multiple comparisons|ANCOVA|||NCX 0.065% was compared to latanoprost.||-0.51|-1.96|0.0009
71749778|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.03||||0.091|TWO_SIDED|95.0|0.84|10.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.94|0.84|0.0910
71749779|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0296|TWO_SIDED|95.0|1.15|13.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.67|1.15|0.0296
71749780|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|8.23||||0.0009|TWO_SIDED|95.0|2.38|28.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||28.44|2.38|0.0009
71749781|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|8.54||||0.0007|TWO_SIDED|95.0|2.46|29.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||29.63|2.46|0.0007
71749782|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4152|TWO_SIDED|95.0|0.45|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.86|0.45|0.4152
71749783|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.29||||0.07|TWO_SIDED|95.0|0.91|11.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.93|0.91|0.0700
71781655|NCT01153347|143062731|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|1.08||1|TWO_SIDED|95.0|-2.67|1.57|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.57|-2.67|1.000
71781656|NCT01153347|143062731|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|1.09||1|TWO_SIDED|95.0|-2.26|2.04|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.04|-2.26|1.000
71781657|NCT01153347|143062732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.24||0.967|TWO_SIDED|95.0|0.64|1.6|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.60|0.64|0.967
71781658|NCT01153347|143062732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.21||0.67|TWO_SIDED|95.0|0.57|1.43|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.43|0.57|0.670
71781659|NCT01153347|143062732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.544|TWO_SIDED|95.0|0.54|1.38|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.38|0.54|0.544
71781660|NCT01153347|143062733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.24||0.73|TWO_SIDED|95.0|0.55|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.53|0.55|0.730
71781661|NCT01153347|143062733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.23||0.671|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.53|0.671
71835353|NCT04157348|143175606|SUPERIORITY||difference in response rates|0.046|||||TWO_SIDED|95.0|-0.0422|0.1341|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|any clinical response-definition 1||0.1341|-0.0422|
71835354|NCT04157348|143175606|SUPERIORITY||difference in response rates|0.079|||||TWO_SIDED|95.0|-0.0732|0.2312|||Regression, Logistic|marginal standardization method|The difference of response rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|complete response-definition 1||0.2312|-0.0732|
71891575|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.235|0.077|0.0001
71891576|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.176|0.011|0.0255
71749784|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|5.83||||0.0048|TWO_SIDED|95.0|1.71|19.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||19.84|1.71|0.0048
71749785|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1497|TWO_SIDED|95.0|0.72|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.23|0.72|0.1497
71749786|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0608|TWO_SIDED|95.0|0.95|9.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||9.77|0.95|0.0608
71749787|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|5.99||||0.0028|TWO_SIDED|95.0|1.85|19.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||19.34|1.85|0.0028
71749788|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|7.84||||0.0005|TWO_SIDED|95.0|2.45|25.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.13|2.45|0.0005
71749789|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8393|TWO_SIDED|95.0|0.3|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.39|0.30|0.8393
71749790|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|4.01||||0.0215|TWO_SIDED|95.0|1.23|13.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.10|1.23|0.0215
71749791|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|4.42||||0.0112|TWO_SIDED|95.0|1.4|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.94|1.40|0.0112
71749792|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3498|TWO_SIDED|95.0|0.55|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.29|0.55|0.3498
71749793|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1981|TWO_SIDED|95.0|0.69|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.08|0.69|0.1981
71749794|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0029|TWO_SIDED|95.0|1.76|15.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.78|1.76|0.0029
71749795|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|5.95||||0.0011|TWO_SIDED|95.0|2.03|17.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.40|2.03|0.0011
71749796|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9511|TWO_SIDED|95.0|0.29|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.29|0.9511
71749797|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.76||||0.3241|TWO_SIDED|95.0|0.57|5.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.45|0.57|0.3241
71781662|NCT01153347|143062733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.2||0.308|TWO_SIDED|95.0|0.45|1.29|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.29|0.45|0.308
71749798|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0111|TWO_SIDED|95.0|1.36|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||11.16|1.36|0.0111
71749799|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1375|TWO_SIDED|95.0|0.74|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.48|0.74|0.1375
71749800|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.02||||0.067|TWO_SIDED|95.0|0.93|9.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.83|0.93|0.0670
71891577|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.113|-0.049|0.4393
71891578|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.269|0.108|<0.0001
71668277|NCT03657797|142853140|NON_INFERIORITY|NCX 470 0.021% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.9788||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.51 (week 1), 0.68 (week 2), 0.75 (exit visit); p-values were 0.5560 (week 1), 0.9788 (week 2), 0.8796 (exit visit)||NCX 470 0.021% was compared to latanoprost.||||<0.9788
71668278|NCT03657797|142853140|NON_INFERIORITY|NCX 470 0.042% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.3863||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were 0.20 (week 1), 0.38 (week 2), 0.11 (exit visit); p-values were 0.1556 (week 1), 0.3863 (week 2), 0.0912 (exit visit)||NCX 470 0.042% was compared to latanoprost.||||<0.3863
71749801|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0009|TWO_SIDED|95.0|2.29|25.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||25.04|2.29|0.0009
71749802|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|9.42||||0.0002|TWO_SIDED|95.0|2.91|30.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||30.49|2.91|0.0002
71749803|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0982|TWO_SIDED|95.0|0.83|9.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.14|0.83|0.0982
71749804|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1233|TWO_SIDED|95.0|0.77|8.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.80|0.77|0.1233
71749805|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0091|TWO_SIDED|95.0|1.46|14.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.64|1.46|0.0091
71749806|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.34|3.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.10|0.34|0.9620
71749807|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3527|TWO_SIDED|95.0|0.58|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.59|0.58|0.3527
71749808|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.04||||0.0394|TWO_SIDED|95.0|1.06|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.76|1.06|0.0394
71749809|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0224|TWO_SIDED|95.0|1.19|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.53|1.19|0.0224
71781663|NCT01153347|143062734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|STANDARD_ERROR_OF_MEAN|0.4||0.905|TWO_SIDED|95.0|0.42|2.15|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.15|0.42|0.905
71749810|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7891|TWO_SIDED|95.0|0.39|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.44|0.39|0.7891
71749811|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.48||||0.0851|TWO_SIDED|95.0|0.88|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.99|0.88|0.0851
71891579|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.092|-0.069|0.7784
71891580|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.026|-0.129|0.1965
71891581|NCT01431287|143304572|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|||||0.144|-0.019|0.1315
71891582|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-1.043|-3.239|0.0001
71891583|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.230|0.0435
71891584|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.432|-2.623|0.0063
71891585|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.577|-1.611|0.3545
71891586|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.578|-1.614|0.3542
71891587|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.476|-1.702|0.2697
71891588|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.033|-2.227|0.0434
71891589|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.095|-2.114|0.0732
71891590|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.092|-2.114|0.0724
71891591|NCT01431287|143304573|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.104|-1.102|0.9983
71891592|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.718|-2.985|0.0014
71891593|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.686|-1.573|0.4413
71891594|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.304|-2.569|0.0129
71891595|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.070|-1.182|0.9222
71835355|NCT04157348|143175607|SUPERIORITY||difference in remission rates|0.0554|||||TWO_SIDED|95.0|-0.093|0.2037|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|main remission||0.2037|-0.0930|
71835356|NCT04157348|143175607|SUPERIORITY||difference in remission rates|0.0467|||||TWO_SIDED|95.0|-0.1021|0.1956|||Regression, Logistic|marginal standardization method|The difference of remission rates (Benralizumab - Mepolizumab) and 95% CI are estimated using marginal standardization method in a logistic regression model. The covariates include treatment arm, baseline dose of prednisone, baseline BVAS and region.|supportive remission||0.1956|-0.1021|
71668279|NCT03657797|142853140|NON_INFERIORITY|NCX 470 0.065% was compared to latanoprost 0.005% at each visit. The LS mean, LS mean difference and the 95% CIs for the difference was calculated. Non-inferiority at each visit could be claimed if the upper limit of the 95% CI was \<1.5 mmHg. If non-inferiority was established, superiority could be claimed if the upper limit of the 95% CI was \<0 and p\<0.05.|||||<|0.0174||||||p-value was not adjusted for multiple comparisons|ANCOVA|Upper 95% CIs were -0.35 (week 1), -0.15 (week 2), -0.27 (exit visit); p-values were 0.0040 (week 1), 0.0174 (week 2), 0.0093 (exit visit)||NCX 470 0.065% was compared to latanoprost.||||<0.0174
71749812|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2885|TWO_SIDED|95.0|0.63|4.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.83|0.63|0.2885
71749813|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8611|TWO_SIDED|95.0|0.05|13.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||13.30|0.05|0.8611
71749814|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.48||||0.7549|TWO_SIDED|95.0|0.13|17.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||17.42|0.13|0.7549
71749815|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|2.07||||0.5658|TWO_SIDED|95.0|0.17|24.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||24.66|0.17|0.5658
71749816|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.83||||0.6319|TWO_SIDED|95.0|0.15|21.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||21.86|0.15|0.6319
71749817|NCT03192176|143005308|SUPERIORITY||Odds Ratio (OR)|1.09||||0.9526|TWO_SIDED|95.0|0.06|18.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||18.96|0.06|0.9526
71749818|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2251|TWO_SIDED|95.0|0.71|4.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.26|0.71|0.2251
71835357|NCT00715884|143175636|NON_INFERIORITY_OR_EQUIVALENCE|The null inferiority hypothesis was that the upper limit of the 95% confidence interval is equal or greater than the non-inferiority margin 5%. The alternative non-inferiority hypothesis for this study assumed that the upper limit of the 95% confidence interval would be less than the non-inferiority margin 5%.|Difference between TLF rates|2.58|||||ONE_SIDED|95.0||5.55||In the CYPHER® ELITE™ arm the TLF rate was 5.36% (23/429) compared with 2.78% (6/216) in the CYPHER® Bx VELOCITY® arm, a difference in rates of 2.58%, upper limit of 95% two sided confidence interval of 5.55%.||||Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.||5.55||
71835358|NCT00715884|143175637|SUPERIORITY_OR_OTHER||Difference between event rates|-0.4||||0.549|TWO_SIDED|95.0|-1.3|1.0|||Fisher Exact|||||1.0|-1.3|0.549
71835359|NCT00715884|143175638|SUPERIORITY_OR_OTHER||Difference between event rates|13.8|||<|0.001|TWO_SIDED|95.0|9.2|18.9|||Fisher Exact|||||18.9|9.2|<.001
71749819|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0084|TWO_SIDED|95.0|1.39|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.39|0.0084
71749820|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.71||||0.0007|TWO_SIDED|95.0|2.09|15.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.62|2.09|0.0007
71749821|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.11||||0.0015|TWO_SIDED|95.0|1.87|14.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.00|1.87|0.0015
71835360|NCT00715884|143175639|SUPERIORITY_OR_OTHER||Difference between event rates|0.7||||0.724|TWO_SIDED|95.0|-2.2|4.2|||Fisher Exact|||||4.2|-2.2|0.724
71835361|NCT00715884|143175640|SUPERIORITY_OR_OTHER||Difference between event rates|-1.3||||0.407|TWO_SIDED|95.0|-3.5|1.4|||Fisher Exact|||||1.4|-3.5|0.407
71835362|NCT00715884|143175641|SUPERIORITY_OR_OTHER||Difference between event rates|2.11||||0.203|TWO_SIDED|95.0|-0.84|4.48|||Fisher Exact|||||4.48|-0.84|0.203
71781664|NCT01153347|143062734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.39||0.864|TWO_SIDED|95.0|0.41|2.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.14|0.41|0.864
71781665|NCT01153347|143062734|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.42||0.958|TWO_SIDED|95.0|0.43|2.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.25|0.43|0.958
71781666|NCT01153347|143062735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91|STANDARD_ERROR_OF_MEAN|0.3||0.778|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.73|0.48|0.778
71781667|NCT01153347|143062735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|STANDARD_ERROR_OF_MEAN|0.38||0.532|TWO_SIDED|95.0|0.66|2.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.24|0.66|0.532
71781668|NCT01153347|143062735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.29||0.633|TWO_SIDED|95.0|0.44|1.64|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.64|0.44|0.633
71781669|NCT01153347|143062736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.42||0.949|TWO_SIDED|95.0|0.46|2.31|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.31|0.46|0.949
71781670|NCT01153347|143062736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|STANDARD_ERROR_OF_MEAN|0.62||0.253|TWO_SIDED|95.0|0.72|3.4|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.40|0.72|0.253
71781671|NCT01153347|143062736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|STANDARD_ERROR_OF_MEAN|0.39||0.763|TWO_SIDED|95.0|0.37|2.08|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.08|0.37|0.763
71781672|NCT01153347|143062737|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|0.78||0.207|TWO_SIDED|95.0|-2.51|0.55|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.55|-2.51|0.207
71835363|NCT00715884|143175642|SUPERIORITY_OR_OTHER||Difference between event rates|2.35||||0.22|TWO_SIDED|95.0|-1.24|5.28|||Fisher Exact|||||5.28|-1.24|0.22
71781673|NCT01153347|143062737|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.427|TWO_SIDED|95.0|-2.16|0.91|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.91|-2.16|0.427
71781674|NCT01153347|143062737|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.78||0.591|TWO_SIDED|95.0|-1.96|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-1.96|0.591
71781675|NCT01153347|143062738|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.551||95.0|-0.34|0.18|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.18|-0.34|0.551
71781676|NCT01153347|143062738|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.487|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.17|-0.36|0.487
71781677|NCT01153347|143062738|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.78|TWO_SIDED|95.0|-0.23|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.23|0.780
71781678|NCT01153347|143062739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.23||0.908|TWO_SIDED|95.0|0.62|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.53|0.62|0.908
71781679|NCT01153347|143062739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.24||0.803|TWO_SIDED|95.0|0.67|1.67|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.67|0.67|0.803
71781680|NCT01153347|143062739|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|0.41|1.03|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.03|0.41|0.066
71835364|NCT00715884|143175643|SUPERIORITY_OR_OTHER||Difference between event rates|2.83||||0.166|TWO_SIDED|95.0|-1.28|6.26|||Fisher Exact|||||6.26|-1.28|0.166
71668280|NCT01050530|142853158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.0001|TWO_SIDED|95.0|-2.08|-0.93|||t-test, 2 sided|||||-0.93|-2.08|<0.0001
71835365|NCT00715884|143175644|SUPERIORITY_OR_OTHER||Difference between event rates|2.59||||0.2|TWO_SIDED|95.0|-1.35|5.85|||Fisher Exact|||||5.85|-1.35|0.200
71781681|NCT01153347|143062740|SUPERIORITY_OR_OTHER||LS mean|-0.82|STANDARD_ERROR_OF_MEAN|0.645||0.202|TWO_SIDED|95.0|-2.091|0.442|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.442|-2.091|0.202
71781682|NCT01153347|143062740|SUPERIORITY_OR_OTHER||LS mean|-0.22|STANDARD_ERROR_OF_MEAN|0.647||0.738|TWO_SIDED|95.0|-1.487|1.055|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.055|-1.487|0.738
71781683|NCT01153347|143062740|SUPERIORITY_OR_OTHER||LS mean|-0.51|STANDARD_ERROR_OF_MEAN|0.65||0.433|TWO_SIDED|95.0|-1.787|0.767|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.767|-1.787|0.433
71781684|NCT01153347|143062741|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.097|TWO_SIDED|95.0|-0.18|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.18|0.097
71781685|NCT01153347|143062741|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.882|TWO_SIDED|95.0|-1.29|1.11|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-1.29|0.882
71781686|NCT01153347|143062741|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.1|TWO_SIDED|95.0|-0.19|2.23|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.23|-0.19|0.100
71781687|NCT01153347|143062742|SUPERIORITY_OR_OTHER||LS mean|0.8|STANDARD_ERROR_OF_MEAN|0.74||0.303|TWO_SIDED|95.0|-0.69|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-0.69|0.303
71781688|NCT01153347|143062742|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.74||0.793|TWO_SIDED|95.0|-1.26|1.65|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.65|-1.26|0.793
71781689|NCT01153347|143062742|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.75||0.762|TWO_SIDED|95.0|-1.7|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.25|-1.70|0.762
71781690|NCT01153347|143062743|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.339|TWO_SIDED|95.0|-2.65|0.92|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.92|-2.65|0.339
71781691|NCT01153347|143062743|SUPERIORITY_OR_OTHER||LS mean|-0.9|STANDARD_ERROR_OF_MEAN|0.91||0.321|TWO_SIDED|95.0|-2.7|0.89|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.89|-2.70|0.321
71781692|NCT01153347|143062743|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.92||0.68|TWO_SIDED|95.0|-2.2|1.43|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.43|-2.20|0.680
71781693|NCT01153347|143062744|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.737|TWO_SIDED|95.0|-2.23|1.58|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.58|-2.23|0.737
71781694|NCT01153347|143062744|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.547|TWO_SIDED|95.0|-2.52|1.33|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.33|-2.52|0.547
71781695|NCT01153347|143062744|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.99||0.953|TWO_SIDED|95.0|-1.89|2.01|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.01|-1.89|0.953
71781696|NCT01153347|143062745|SUPERIORITY_OR_OTHER||LS mean|-0.6|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-2.069|0.864||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.864|-2.069|1.000
71781697|NCT01153347|143062745|SUPERIORITY_OR_OTHER||LS mean|-0.52|STANDARD_ERROR_OF_MEAN|0.755||1|TWO_SIDED|95.0|-2.004|0.96||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.960|-2.004|1.000
71781698|NCT01153347|143062745|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.761||1|TWO_SIDED|95.0|-1.095|1.896||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.896|-1.095|1.000
71781699|NCT01153347|143062746|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.953|TWO_SIDED|95.0|-0.56|0.59|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.59|-0.56|0.953
71781700|NCT01153347|143062746|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.868|TWO_SIDED|95.0|-0.64|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.64|0.868
71781701|NCT01153347|143062746|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.5|0.66|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.66|-0.50|0.792
71835366|NCT00715884|143175645|SUPERIORITY_OR_OTHER||Difference between event rates|11.56||||0.14|TWO_SIDED|95.0|-3.73|24.64|||Fisher Exact|||||24.64|-3.73|0.140
71781702|NCT01153347|143062747|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.915|TWO_SIDED|95.0|-0.54|0.48|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.48|-0.54|0.915
71668281|NCT01050530|142853159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-300.7||||0.0093|TWO_SIDED|95.0|-526.2|-75.1|||t-test, 2 sided|||||-75.1|-526.2|0.0093
71781703|NCT01153347|143062747|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.972|TWO_SIDED|95.0|-0.51|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.53|-0.51|0.972
71835367|NCT00715884|143175646|SUPERIORITY_OR_OTHER||Difference between event rates|5.17||||0.17|TWO_SIDED|95.0|-2.03|10.83|||Fisher Exact|||||10.83|-2.03|0.170
71835368|NCT00715884|143175647|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-5.61|5.43|||Fisher Exact|||||5.43|-5.61|1.0
71668282|NCT00276484|142853181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-19.4|-13.2|||ANCOVA|Model terms: treatment and baseline LDL-C value||||-13.2|-19.4|<0.001
71781704|NCT01153347|143062747|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.237|TWO_SIDED|95.0|-0.21|0.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.84|-0.21|0.237
71835369|NCT00715884|143175648|SUPERIORITY_OR_OTHER||Difference between event rates|0.24||||1|TWO_SIDED|95.0|-1.92|1.63|||Fisher Exact|||||1.63|-1.92|1.0
71835370|NCT00715884|143175649|SUPERIORITY_OR_OTHER||Difference between event rates|0.49||||0.801|TWO_SIDED|95.0|-2.73|2.91|||Fisher Exact|||||2.91|-2.73|0.801
71781705|NCT01153347|143062748|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.213|TWO_SIDED|95.0|-0.87|0.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.19|-0.87|0.213
71835371|NCT00715884|143175650|SUPERIORITY_OR_OTHER||Difference between event rates|-0.92||||0.341|TWO_SIDED|95.0|-3.56|0.6|||Fisher Exact|||||0.60|-3.56|0.341
71835372|NCT00715884|143175651|SUPERIORITY_OR_OTHER||Difference between event rates|0.0||||1|TWO_SIDED|95.0|-2.14|1.28|||Fisher Exact|||||1.28|-2.14|1.00
71835373|NCT00715884|143175652|SUPERIORITY_OR_OTHER||Difference between event rates|0.47||||0.668|TWO_SIDED|95.0|-1.72|1.96|||Fisher Exact|||||1.96|-1.72|0.668
71835374|NCT02412748|143175706|SUPERIORITY|||||||0.962|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.962
71781706|NCT01153347|143062748|SUPERIORITY_OR_OTHER||LS mean|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.343|TWO_SIDED|95.0|-0.8|0.28|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.28|-0.80|0.343
71781707|NCT01153347|143062748|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.971|TWO_SIDED|95.0|-0.55|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.53|-0.55|0.971
71781708|NCT01153347|143062749|SUPERIORITY_OR_OTHER||LS mean|2.1|STANDARD_ERROR_OF_MEAN|1.694||0.215|TWO_SIDED|95.0|-1.224|5.431|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||5.431|-1.224|0.215
71781709|NCT01153347|143062749|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|1.702||0.673|TWO_SIDED|95.0|-2.624|4.062|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.062|-2.624|0.673
71781710|NCT01153347|143062749|SUPERIORITY_OR_OTHER||LS mean|-1.88|STANDARD_ERROR_OF_MEAN|1.716||0.275|TWO_SIDED|95.0|-5.248|1.494|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.494|-5.248|0.275
71781711|NCT01153347|143062750|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.412|TWO_SIDED|95.0|-0.28|0.11|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.11|-0.28|0.412
71781712|NCT01153347|143062750|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.928|TWO_SIDED|95.0|-0.19|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.19|0.928
71781713|NCT01153347|143062750|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||-0.02|-0.42|0.033
71781714|NCT01153347|143062751|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.353|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.28|-0.10|0.353
71781715|NCT01153347|143062751|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.721|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.23|-0.16|0.721
71781716|NCT01153347|143062751|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.666|TWO_SIDED|95.0|-0.24|0.15|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.15|-0.24|0.666
71781717|NCT01153347|143062752|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0201||0.747|TWO_SIDED|95.0|-0.0459|0.0329||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0329|-0.0459|0.747
71781718|NCT01153347|143062752|SUPERIORITY_OR_OTHER||LS mean|-0.013|STANDARD_ERROR_OF_MEAN|0.0203||0.524|TWO_SIDED|95.0|-0.0529|0.027||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0270|-0.0529|0.524
71781719|NCT01153347|143062752|SUPERIORITY_OR_OTHER||LS mean|-0.014|STANDARD_ERROR_OF_MEAN|0.0206||0.502|TWO_SIDED|95.0|-0.0543|0.0267||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0267|-0.0543|0.502
71781720|NCT01153347|143062752|SUPERIORITY_OR_OTHER||LS mean|1.9|STANDARD_ERROR_OF_MEAN|2.06||0.345|TWO_SIDED|95.0|-2.1|6.0||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.00|-2.10|0.345
71781721|NCT01153347|143062752|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|2.09||0.486|TWO_SIDED|95.0|-2.65|5.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||5.56|-2.65|0.486
71781722|NCT01153347|143062752|SUPERIORITY_OR_OTHER||LS mean|-1.2|STANDARD_ERROR_OF_MEAN|2.12||0.564|TWO_SIDED|95.0|-5.39|2.94||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.94|-5.39|0.564
71781723|NCT01153347|143062753|SUPERIORITY_OR_OTHER||LS mean|-1.4|STANDARD_ERROR_OF_MEAN|1.55||0.35|TWO_SIDED|95.0|-4.48|1.59|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.59|-4.48|0.350
71668283|NCT00276484|142853182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.8||0.551||95.0|-1.1|2.1|||ANCOVA|Model terms: treatment and baseline HDL-C value||||2.1|-1.1|0.551
71668284|NCT00276484|142853183|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-17.1|-11.6|||ANCOVA|Model terms: treatment and baseline non-HDL-C value||||-11.6|-17.1|<0.001
71668285|NCT00276484|142853184|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-12.0|-7.9|||ANCOVA|Model terms: treatment and baseline Total-C value||||-7.9|-12.0|<0.001
71668286|NCT00276484|142853185|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.3|||<|0.001||95.0|-11.5|-3.1|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.|||-3.1|-11.5|<0.001
71781724|NCT01153347|143062753|SUPERIORITY_OR_OTHER||LS mean|-1.3|STANDARD_ERROR_OF_MEAN|1.56||0.393|TWO_SIDED|95.0|-4.41|1.73|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-4.41|0.393
71781725|NCT01153347|143062753|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|1.58||0.745|TWO_SIDED|95.0|-2.59|3.62|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.62|-2.59|0.745
71781726|NCT03130257|143062754|EQUIVALENCE|The study planned for a sample size of 510 and 80% protocol completion, resulting in sample size 136 per group. With this sample size, the least detectable difference (LDD) is 4.1 mmHg systolic BP (SBP) and 2.8 mmHg diastolic BP (DBP) between any two groups (assuming Standard Deviation 12.1 and 8.3 for SBP and DBP respectively). Actual sample sizes completing protocol were 142, 149, and 111 for Clinic, Home, and Kiosk groups respectively, resulting in LDD of at least 4.3 for SBP and 3.0 for DBP.|||||<|0.05|||||||Regression, Linear|||We used linear regression models to estimate the mean difference in BP between diagnostic measurement and daytime average 24-hr BP for each randomization group. Models were estimated using generalized estimating equations with robust standard errors, and adjusted for age, sex, BMI, education, and baseline systolic and diastolic BP. Separate models estimated mean differences (diagnostic protocol - 24-hr BP) between groups for systolic and diastolic BP.||||<0.05
71781727|NCT01751178|143062782|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.061|||<|0.0001|TWO_SIDED|95.0|-0.081|-0.041||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two groups.||-0.041|-0.081|<0.0001
71781728|NCT01751178|143062782|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|||<|0.0001|TWO_SIDED|95.0|-0.09|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.050|-0.090|<0.0001
71781729|NCT01751178|143062783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.1|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis that there was no difference between the two treatment groups.||-0.05|-0.10|<0.0001
71781730|NCT01751178|143062783|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.11|-0.06||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.||-0.06|-0.11|<0.0001
71781731|NCT01751178|143062784|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.62||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.||-0.62|-0.98|<0.0001
71781732|NCT01751178|143062784|SUPERIORITY_OR_OTHER||Adusted Mean Difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.68||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.||-0.68|-1.04|<0.0001
71668287|NCT00276484|142853186|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-12.7|-7.6|||ANCOVA|Model terms: treatment and baseline Apo B value||||-7.6|-12.7|<0.001
71668288|NCT00276484|142853187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.313||95.0|-0.8|2.5|||ANCOVA|Model terms: treatment and baseline Apo A-I value||||2.5|-0.8|0.313
71835375|NCT02412748|143175707|SUPERIORITY|||||||0.982|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.982
71668289|NCT00276484|142853188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-12.6|-8.2|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value||||-8.2|-12.6|<0.001
71781733|NCT01751178|143062785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.69||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two treatments.||-0.69|-1.07|<0.0001
71781734|NCT01751178|143062785|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.16|-0.78||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two groups.||-0.78|-1.16|<0.0001
71781735|NCT00289991|143062793|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a true success rate of 50% in voriconazole (Vori) treatment (Tx) group and 45% in itraconazole (Itra) Tx group, sample size of 232 subjects per group=90% power to demonstrate non-inferiority of Vori to Itra using pre-specified non-inferiority margin of -10%. Sample has at least 80% power to demonstrate superiority of Vori over Itra if true success rates for Vori and Itra are 57% and 44% respectively. Based on this, up to 500 subjects were to be enrolled to obtain 464 eligible subjects.|percent difference adjusted proportions|16.4|||||TWO_SIDED|95.0|7.7|25.1|||Difference in adjusted responder rates|Difference in adjusted responder rates using Fleiss method|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|"Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant does not include zero and is positive."||25.1|7.7|
71781736|NCT00289991|143062794|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority inferred if lower limit of the 2-sided 95% confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant does not include zero and is positive."|percent difference adjusted proportions|15.4|||||TWO_SIDED|95.0|6.6|24.2|||Difference in adjusted responder rates|Difference in adjusted responder rates using the Fleiss method.|Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|||24.2|6.6|
71781737|NCT00289991|143062796|SUPERIORITY_OR_OTHER||difference in proportions: percent|-0.4||||0.7114|TWO_SIDED|95.0|-2.2|1.5|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 100; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.5|-2.2|0.7114
71781738|NCT00289991|143062796|SUPERIORITY_OR_OTHER||difference in proportion: percent|-0.3||||0.7759|TWO_SIDED|95.0|-2.5|1.9|||Difference in proportions|Difference in proportions (approximate result).|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.||1.9|-2.5|0.7759
71781739|NCT00289991|143062797|SUPERIORITY_OR_OTHER||difference in proportions: percent|0.3|||||TWO_SIDED|95.0|-6.3|6.9|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||6.9|-6.3|
71781740|NCT00289991|143062798|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon (Mann-Whitney)||Mann-Whitney test used to investigate the null hypothesis that the times to discontinuation of study medication in each treatment group come from the same distribution.||||0.0026
71781741|NCT00289991|143062799|SUPERIORITY_OR_OTHER||difference in proportions: percent|-4.8||||0.2487|TWO_SIDED|95.0|-13.0|3.4|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent % confidence interval for the difference in proportions.|Day 365; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||3.4|-13.0|0.2487
71781742|NCT00289991|143062801|SUPERIORITY_OR_OTHER||difference in proportions: percent|-8.8||||0.057|TWO_SIDED|95.0|-17.8|0.3|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.||0.3|-17.8|0.0570
71781743|NCT01606007|143062826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.1112|<|0.0001|TWO_SIDED|95.0|-0.81|-0.37||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.37|-0.81|<0.0001
71781744|NCT01606007|143062826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1108||0.0166|TWO_SIDED|95.0|-0.48|-0.05||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis|||||-0.05|-0.48|0.0166
71891596|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.100|-1.157|0.9602
71781745|NCT01606007|143062827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|STANDARD_ERROR_OF_MEAN|4.914|<|0.0001|TWO_SIDED|95.0|-53.7|-34.3||Each secondary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|ANCOVA|||LOCF||-34.3|-53.7|<0.0001
71781746|NCT01606007|143062827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|4.923||0.0639|TWO_SIDED|95.0|-18.8|0.5||Each secondary endpoint was tested at alpha=0.05; significance testing stops at the endpoint where p-value\>0.05.|ANCOVA|||LOCF||0.5|-18.8|0.0639
71668290|NCT00276484|142853189|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-19.9|-13.1|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value||||-13.1|-19.9|<0.001
71668291|NCT00276484|142853190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-13.8|-8.2|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value||||-8.2|-13.8|<0.001
71668292|NCT00276484|142853191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.5|STANDARD_ERROR_OF_MEAN|-1.6|<|0.001||95.0|-17.7|-11.3|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value||||-11.3|-17.7|<0.001
71668293|NCT00276484|142853192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8||||0.174||95.0|-17.1|3.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.|Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.|||3.4|-17.1|0.174
71781747|NCT01606007|143062828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|3.988|||TWO_SIDED|95.0|-31.6|-15.9|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-15.9|-31.6|
71781748|NCT01606007|143062828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.957|||TWO_SIDED|95.0|-13.8|1.7|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||1.7|-13.8|
71668294|NCT00276484|142853193|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.37|||<|0.001||95.0|5.45|12.84|||Regression, Logistic|Model terms: treatment and baseline LDL-C value||||12.84|5.45|<0.001
71668295|NCT02440464|142853194|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.10.|Log Rank|||The null hypothesis is that there is no difference in progression-free survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||1.0
71749822|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6976|TWO_SIDED|95.0|0.48|2.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||2.95|0.48|0.6976
71781749|NCT01606007|143062829|SUPERIORITY_OR_OTHER||Mean difference in percentages|23.1|STANDARD_ERROR_OF_MEAN|4.282|||TWO_SIDED|95.0|14.7|31.5|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||31.5|14.7|
71781750|NCT01606007|143062829|SUPERIORITY_OR_OTHER||Mean difference in percentages|19.1|STANDARD_ERROR_OF_MEAN|4.587|||TWO_SIDED|95.0|10.1|28.1|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||28.1|10.1|
71781751|NCT01606007|143062830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|0.3451|||TWO_SIDED|95.0|-2.73|-1.37|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value\>0.05.|||-1.37|-2.73|
71781752|NCT00332163|143062831|SUPERIORITY_OR_OTHER||Difference|-33.0|||||TWO_SIDED|95.0|-51.0|-14.0|||||Difference = Pre-emptive - Reactive|||-14|-51|
71749823|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|4.57||||0.0021|TWO_SIDED|95.0|1.73|12.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.05|1.73|0.0021
71749824|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0171|TWO_SIDED|95.0|1.22|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.68|1.22|0.0171
71781753|NCT00332163|143062832|SUPERIORITY_OR_OTHER||Difference|-22.0|||||TWO_SIDED|95.0|-42.0|-3.0|||||Difference = Pre-emptive - Reactive|||-3|-42|
71749825|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2224|TWO_SIDED|95.0|0.69|5.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.04|0.69|0.2224
71749826|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.74||||0.2716|TWO_SIDED|95.0|0.65|4.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.69|0.65|0.2716
71749827|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|4.49||||0.0112|TWO_SIDED|95.0|1.41|14.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.32|1.41|0.0112
71749828|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.08||||0.0461|TWO_SIDED|95.0|1.02|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.31|1.02|0.0461
71749829|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3463|TWO_SIDED|95.0|0.59|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.47|0.59|0.3463
71891597|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|-1.533|0.4669
71668296|NCT02440464|142853195|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with acute grade III-IV GVHD between the Ixazomib and Placebo arms during 100 days post-randomization, with death prior to acute GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
71668297|NCT02440464|142853196|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to chronic GVHD treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
71668298|NCT02440464|142853197|SUPERIORITY|The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||||0.89|||||||Fisher Exact|Statistical significance was determined using a pre-specified one-sided threshold of 0.05.||Participants in sCR/CR at Randomization||||0.890
71668299|NCT02440464|142853197|SUPERIORITY|||||||0.754||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Fisher Exact|||The null hypothesis is that there is no difference in the proportions of participants in the best response to treatment categories between the Ixazomib and Placebo arms during 2 years post-transplant among participants not in sCR/CR at randomization. These proportions were compared using Fisher's Exact test.||||0.754
71668300|NCT02440464|142853199|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with progression between the Ixazomib and Placebo arms during 21 months post-randomization, with death prior to progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||1.0
71668301|NCT02440464|142853200|SUPERIORITY|||||||0.174||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference in overall survival time post-randomization among randomized subjects receiving Ixazomib vs Placebo maintenance therapy during the 21 month period post-randomization. This was compared between treatment arms using a log rank test.||||0.174
71668302|NCT02440464|142853201|SUPERIORITY|||||||0.173||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Gray's Test|||The null hypothesis is that there is no difference in the proportions of participants with treatment-related mortality between the Ixazomib and Placebo arms during 21 months post-randomization, with progression treated as a competing risk. Cumulative incidences are compared between treatment arms using Gray's test.||||0.173
71749830|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0419|TWO_SIDED|95.0|1.04|8.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.92|1.04|0.0419
71749831|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.68||||0.2977|TWO_SIDED|95.0|0.63|4.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.46|0.63|0.2977
71749832|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|95.0|0.67|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.21|0.67|0.2300
71749833|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.83||||0.0655|TWO_SIDED|95.0|0.94|8.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.58|0.94|0.0655
71749834|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0245|TWO_SIDED|95.0|1.19|12.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.11|1.19|0.0245
71781754|NCT00332163|143062833|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (pre-emptive vs. reactive), stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
71749835|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.62||||0.0129|TWO_SIDED|95.0|1.44|21.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.93|1.44|0.0129
71781755|NCT00332163|143062835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||0.7|0.2|
71781756|NCT00332163|143062836|SUPERIORITY_OR_OTHER||Difference|-4.0|||||TWO_SIDED|95.0|-16.0|7.0|||||Difference = Pre-emptive - Reactive|||7|-16|
71781757|NCT00332163|143062837|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|95.0|-10.0|10.0|||||Difference = Pre-emptive - Reactive|||10|-10|
71835376|NCT02412748|143175708|SUPERIORITY|||||||0.534|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.534
71835377|NCT02412748|143175709|SUPERIORITY|||||||0.73|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.730
71749836|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1259|TWO_SIDED|95.0|0.79|7.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.15|0.79|0.1259
71749837|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1015|TWO_SIDED|95.0|0.84|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.82|0.84|0.1015
71749838|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0167|TWO_SIDED|95.0|1.31|15.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.33|1.31|0.0167
71749839|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5232|TWO_SIDED|95.0|0.5|3.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.95|0.50|0.5232
71749840|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.0||||0.2055|TWO_SIDED|95.0|0.68|5.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.82|0.68|0.2055
71749841|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0658|TWO_SIDED|95.0|0.93|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.64|0.93|0.0658
71749842|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0136|TWO_SIDED|95.0|1.51|35.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||35.75|1.51|0.0136
71749843|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3238|TWO_SIDED|95.0|0.59|5.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.00|0.59|0.3238
71749844|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0118|TWO_SIDED|95.0|1.48|23.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||23.21|1.48|0.0118
71749845|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.29||||0.0163|TWO_SIDED|95.0|1.36|20.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||20.62|1.36|0.0163
71749846|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6363|TWO_SIDED|95.0|0.42|4.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.18|0.42|0.6363
71749847|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.68||||0.0722|TWO_SIDED|95.0|0.89|15.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.25|0.89|0.0722
71749848|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.35||||0.2019|TWO_SIDED|95.0|0.63|8.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.73|0.63|0.2019
71749849|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|10.15||||0.0337|TWO_SIDED|95.0|1.2|86.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||86.09|1.20|0.0337
71749850|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.25||||0.2207|TWO_SIDED|95.0|0.61|8.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.24|0.61|0.2207
71749851|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.5||||0.0849|TWO_SIDED|95.0|0.84|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.57|0.84|0.0849
71891598|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.656|-1.598|0.4126
71668303|NCT02440464|142853203|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
71781758|NCT00332163|143062838|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|95.0|-9.0|17.0|||||Rate difference = Pre-emptive - Reactive|||17|-9|
71781759|NCT00332163|143062839|SUPERIORITY_OR_OTHER||Difference|-1.0|||||TWO_SIDED|95.0|-21.0|18.0|||||Rate difference = Pre-emptive - Reactive|||18|-21|
71781760|NCT00332163|143062840|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.0|0.9|
71781761|NCT00332163|143062841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.5|0.6|
71781762|NCT00332163|143062842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||2.1|0.7|
71781763|NCT00332163|143062843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.6|||||Hazard ratio is estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).|||1.6|0.6|
71781764|NCT02621060|143062845|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|STANDARD_DEVIATION|2.0||0.004|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
71781765|NCT02621060|143062846|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
71781766|NCT02621060|143062847|SUPERIORITY_OR_OTHER|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||||||0.755
71781767|NCT02621060|143062848|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71781768|NCT02621060|143062849|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
71781769|NCT02621060|143062850|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71781770|NCT02621060|143062852|SUPERIORITY_OR_OTHER|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
71781771|NCT02621060|143062853|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
71781772|NCT02621060|143062854|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
71781773|NCT02621060|143062855|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.022|TWO_SIDED|5.0|||||Wilcoxon (Mann-Whitney)|||||||0.022
71781774|NCT02621060|143062856|SUPERIORITY_OR_OTHER|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
71781775|NCT02621060|143062857|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71781776|NCT02621060|143062858|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781777|NCT02621060|143062859|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781778|NCT02621060|143062860|SUPERIORITY_OR_OTHER|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
71781779|NCT02621060|143062861|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71781780|NCT02621060|143062862|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71781781|NCT02621060|143062863|SUPERIORITY_OR_OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
71781782|NCT02621060|143062864|SUPERIORITY_OR_OTHER|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||||||0.472
71781783|NCT02621060|143062865|SUPERIORITY_OR_OTHER|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
71781784|NCT02621060|143062866|SUPERIORITY_OR_OTHER|||||||0.637|||||||Wilcoxon (Mann-Whitney)|||||||0.637
71781785|NCT03733470|143062867|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71781786|NCT01010061|143062868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.16|0.28||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.28|0.16|<0.0001
71781787|NCT01010061|143062870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.14|0.27|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.27|0.14|<0.0001
71781788|NCT01010061|143062873|SUPERIORITY||Difference in Response Rates|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||55.5|34.7|< 0.0001
71781789|NCT01010061|143062874|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.26|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.26|0.15|<0.0001
71781790|NCT01010061|143062875|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0196|TWO_SIDED|95.0|0.49|0.94|||Log Rank, Stratified|||||0.94|0.49|0.0196
71781791|NCT01010061|143062876|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.28|0.13|<0.0001
71781792|NCT01010061|143062878|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.35|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.35|0.19|<0.0001
71781793|NCT01146834|143062920|SUPERIORITY||Risk Difference (RD)|-0.02||||0.9|TWO_SIDED|95.0|-0.32|0.28|||Chi-squared|||Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.||0.28|-0.32|0.90
71749852|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.47||||0.0844|TWO_SIDED|95.0|0.84|14.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.24|0.84|0.0844
71749853|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2383|TWO_SIDED|95.0|0.6|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.65|0.60|0.2383
71749854|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1653|TWO_SIDED|95.0|0.68|9.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.58|0.68|0.1653
71749855|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1836|TWO_SIDED|95.0|0.65|9.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.48|0.65|0.1836
71749856|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|8.3||||0.0529|TWO_SIDED|95.0|0.97|70.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||70.80|0.97|0.0529
71749857|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3197|TWO_SIDED|95.0|0.52|7.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.27|0.52|0.3197
71749858|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.88||||0.0376|TWO_SIDED|95.0|1.11|31.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||31.25|1.11|0.0376
71749859|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|10.08||||0.0343|TWO_SIDED|95.0|1.19|85.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||85.64|1.19|0.0343
71749860|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4435|TWO_SIDED|95.0|0.49|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.09|0.49|0.4435
71749861|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1805|TWO_SIDED|95.0|0.67|8.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.13|0.67|0.1805
71749862|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0857|TWO_SIDED|95.0|0.84|14.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||14.95|0.84|0.0857
71749863|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0316|TWO_SIDED|95.0|1.23|89.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||89.63|1.23|0.0316
71749864|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3471|TWO_SIDED|95.0|0.52|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.27|0.52|0.3471
71749865|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|6.15||||0.0313|TWO_SIDED|95.0|1.18|32.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||32.09|1.18|0.0313
71749866|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|12.49||||0.0208|TWO_SIDED|95.0|1.47|106.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||106.3|1.47|0.0208
71749867|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8669|TWO_SIDED|95.0|0.31|3.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.97|0.31|0.8669
71749868|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.34||||0.6592|TWO_SIDED|95.0|0.37|4.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.89|0.37|0.6592
71749869|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.23||||0.2923|TWO_SIDED|95.0|0.5|9.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.98|0.50|0.2923
71835378|NCT02412748|143175710|SUPERIORITY|||||||0.927|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.927
71835379|NCT02412748|143175711|SUPERIORITY|||||||0.841|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.841
71749870|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.78||||0.1145|TWO_SIDED|95.0|0.65|51.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||51.04|0.65|0.1145
71749871|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.77||||0.447|TWO_SIDED|95.0|0.4|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.78|0.40|0.4470
71749872|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|7.31||||0.0753|TWO_SIDED|95.0|0.82|65.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||65.41|0.82|0.0753
71749873|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|6.85||||0.0829|TWO_SIDED|95.0|0.78|60.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||60.24|0.78|0.0829
71749874|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9978|TWO_SIDED|95.0|0.28|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.59|0.28|0.9978
71749875|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.68||||0.4571|TWO_SIDED|95.0|0.43|6.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.65|0.43|0.4571
71749876|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.99||||0.3681|TWO_SIDED|95.0|0.44|8.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.94|0.44|0.3681
71749877|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|6.12||||0.1038|TWO_SIDED|95.0|0.69|54.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||54.38|0.69|0.1038
71749878|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4639|TWO_SIDED|95.0|0.39|7.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.72|0.39|0.4639
71749879|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|7.15||||0.077|TWO_SIDED|95.0|0.81|63.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||63.27|0.81|0.0770
71749880|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9838|TWO_SIDED|95.0|0.26|4.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.01|0.26|0.9838
71749881|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.77||||0.6995|TWO_SIDED|95.0|0.21|2.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.86|0.21|0.6995
71749882|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.12||||0.8808|TWO_SIDED|95.0|0.26|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.71|0.26|0.8808
71749883|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|4.94||||0.157|TWO_SIDED|95.0|0.54|45.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||45.13|0.54|0.1570
71749884|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.19||||0.3742|TWO_SIDED|95.0|0.39|12.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.26|0.39|0.3742
71835380|NCT02412748|143175712|SUPERIORITY|||||||0.722|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.722
71835381|NCT02412748|143175713|SUPERIORITY|||||||0.715|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.715
71749885|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.24||||0.1436|TWO_SIDED|95.0|0.57|48.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||48.26|0.57|0.1436
71749886|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.57||||0.1277|TWO_SIDED|95.0|0.61|50.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||50.77|0.61|0.1277
71749887|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6689|TWO_SIDED|95.0|0.2|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||2.81|0.20|0.6689
71749888|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.2||||0.8019|TWO_SIDED|95.0|0.29|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.95|0.29|0.8019
71749889|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9591|TWO_SIDED|95.0|0.23|4.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.05|0.23|0.9591
71749890|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.33||||0.3364|TWO_SIDED|95.0|0.42|13.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.06|0.42|0.3364
71749891|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3698|TWO_SIDED|95.0|0.39|12.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.32|0.39|0.3698
71749892|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|4.92||||0.1587|TWO_SIDED|95.0|0.54|45.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.01|0.54|0.1587
71749893|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.61|50.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.06|0.61|0.1300
71749894|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.81||||0.4152|TWO_SIDED|95.0|0.43|7.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.53|0.43|0.4152
71749895|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9645|TWO_SIDED|95.0|0.27|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.50|0.27|0.9645
71835382|NCT02412748|143175714|SUPERIORITY|||||||0.9|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.900
71835383|NCT02412748|143175715|SUPERIORITY|||||||0.271|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.271
71749896|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3884|TWO_SIDED|95.0|0.43|8.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.96|0.43|0.3884
71749897|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.62||||0.267|TWO_SIDED|95.0|0.48|14.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.41|0.48|0.2670
71677078|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4||||0.5501|TWO_SIDED|95.0|-5.85|3.14||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.14|-5.85|0.5501
71749898|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|6.91||||0.0861|TWO_SIDED|95.0|0.76|62.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||62.90|0.76|0.0861
71749899|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|7.21||||0.0774|TWO_SIDED|95.0|0.8|64.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||64.66|0.80|0.0774
71749900|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|4.73||||0.0389|TWO_SIDED|95.0|1.08|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||20.65|1.08|0.0389
71749901|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.81||||0.3695|TWO_SIDED|95.0|0.5|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.57|0.50|0.3695
71749902|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3501|TWO_SIDED|95.0|0.48|7.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.89|0.48|0.3501
71749903|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.49||||0.2021|TWO_SIDED|95.0|0.61|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.14|0.61|0.2021
71749904|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6201|TWO_SIDED|95.0|0.36|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.62|0.36|0.6201
71749905|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|13.71||||0.0235|TWO_SIDED|95.0|1.42|132.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||132.0|1.42|0.0235
71749906|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.43||||0.0929|TWO_SIDED|95.0|0.81|14.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||14.48|0.81|0.0929
71749907|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.99||||0.982|TWO_SIDED|95.0|0.29|3.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.33|0.29|0.9820
71749908|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4956|TWO_SIDED|95.0|0.44|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.41|0.44|0.4956
71749909|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5708|TWO_SIDED|95.0|0.2|2.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.44|0.20|0.5708
71749910|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1985|TWO_SIDED|95.0|0.61|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.61|0.61|0.1985
71749911|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8368|TWO_SIDED|95.0|0.31|4.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.32|0.31|0.8368
71749912|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|3.18||||0.1397|TWO_SIDED|95.0|0.68|14.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.76|0.68|0.1397
71749913|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.88||||0.0366|TWO_SIDED|95.0|0.52|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.85|0.52|0.0366
71781794|NCT01146834|143062922|SUPERIORITY||Risk Difference (RD)|-0.25||||0.25|TWO_SIDED|95.0|-0.68|0.18|||Fisher Exact|||||0.18|-0.68|0.25
71781795|NCT02021773|143062923|SUPERIORITY||Mean Difference (Final Values)|-22.74|STANDARD_ERROR_OF_MEAN|10.937||0.0386|TWO_SIDED|95.0|-44.28|-1.21||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-1.21|-44.28|0.0386
71781796|NCT02021773|143062923|SUPERIORITY||Mean Difference (Final Values)|-30.41|STANDARD_ERROR_OF_MEAN|10.9||0.0057|TWO_SIDED|95.0|-51.88|-8.95||The threshold for statistical significance was p = .05.|Mixed Models Analysis|||||-8.95|-51.88|0.0057
71749914|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7968|TWO_SIDED|95.0|0.23|3.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.05|0.23|0.7968
71749915|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9074|TWO_SIDED|95.0|0.3|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.81|0.30|0.9074
71749916|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.41||||0.1987|TWO_SIDED|95.0|0.1|1.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.60|0.10|0.1987
71749917|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|2.58||||0.204|TWO_SIDED|95.0|0.6|11.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.18|0.60|0.2040
71749918|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3318|TWO_SIDED|95.0|0.13|1.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.99|0.13|0.3318
71749919|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7437|TWO_SIDED|95.0|0.31|5.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.10|0.31|0.7437
71749920|NCT03192176|143005309|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6848|TWO_SIDED|95.0|0.36|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.71|0.36|0.6848
71835384|NCT02412748|143175716|SUPERIORITY|||||||0.987|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.987
71835385|NCT02412748|143175717|SUPERIORITY|||||||0.967|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.967
71835386|NCT02412748|143175718|SUPERIORITY|||||||0.693|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.693
71891599|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.265|-2.551|0.0158
71749921|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1114|TWO_SIDED|95.0|0.84|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.32|0.84|0.1114
71749922|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|4.69||||0.0013|TWO_SIDED|95.0|1.83|12.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.04|1.83|0.0013
71749923|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|7.01|||<|0.0001|TWO_SIDED|95.0|2.65|18.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.54|2.65|<0.0001
71749924|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|4.96||||0.001|TWO_SIDED|95.0|1.91|12.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.89|1.91|0.0010
71749925|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.25||||0.6384|TWO_SIDED|95.0|0.49|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||3.22|0.49|0.6384
71749926|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|5.77||||0.0003|TWO_SIDED|95.0|2.23|14.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.93|2.23|0.0003
71781797|NCT00282984|143062933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.05|||<|0.0001||95.0|4.13|8.86||To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected \& clinically meaningful var \& pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates \& corresponding 95% OR confidence interval (CI) from A30510285 \& A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.||8.86|4.13|<0.0001
71781798|NCT00282984|143062934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||<|0.0001||95.0|1.97|5.18||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of treatment group \& center as independent var.||Estimates for expected and clinically meaningful var \& pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04) \& a power of 84% for the 2 key secondary endpts.||5.18|1.97|<0.0001
71781799|NCT00282984|143062935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.0001||95.0|1.82|4.38||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary \& 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint \& key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected and clinically meaningful varenicline (var) \& pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates \& corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline \& pbo, assuming true 4-week CQR of 0.18 for pbo \& 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.||4.38|1.82|<0.0001
71781800|NCT00282984|143062936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.97|||<|0.0001||95.0|4.17|8.56|||Regression, Logistic|||Week 12 analysis||8.56|4.17|<0.0001
71781801|NCT00282984|143062937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.93|||<|0.0001||95.0|2.03|4.23|||Regression, Logistic|||24 Week analysis||4.23|2.03|<0.0001
71781802|NCT00282984|143062938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0003||95.0|1.34|2.77|||Regression, Logistic|||52 Week analysis||2.77|1.34|0.0003
71781803|NCT00282984|143062939|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0001||95.0|1.41|2.97|||Regression, Logistic|||||2.97|1.41|0.0001
71781804|NCT00282984|143062940|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.51|5.93|||Regression, Logistic|||||5.93|2.51|<0.0001
71781805|NCT00282984|143062942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.0001||95.0|2.58|5.75|||Regression, Logistic|||||5.75|2.58|<0.0001
71781806|NCT02015754|143062968|OTHER|||||||0.004||||||Differences of p-value \< 0.05 considered statistically significant.|Regression, Cox|||Multivariate Cox-regression analysis to identify independent prognostic factors for overall survival from baseline characteristics. Relative risk with 95% confidence intervals calculated as measure of association.||||0.004
71781807|NCT02015754|143062975|OTHER|VEGF immediately post treatment||||||0.6257|||||||one-sample Wilcoxon signed rank test|||||||0.6257
71781808|NCT02015754|143062975|OTHER|VEGF at 24 hours post treatment.||||||0.4143|||||||one-sample Wilcoxon signed rank test|||||||0.4143
71781809|NCT02015754|143062975|OTHER|VEGFR1 immediately post treatment.||||||0.583|||||||one-sample Wilcoxon signed rank test|||||||0.583
71781810|NCT02015754|143062975|OTHER|VEGFR1 at 24 hours post treatment.||||||0.0012|||||||one-sample Wilcoxon signed rank test|||||||.0012
71781811|NCT02015754|143062975|OTHER|VEGFR2 immediately post treatment.||||||0.1353|||||||one-sample Wilcoxon signed rank test|||||||0.1353
71781812|NCT02015754|143062975|OTHER|VEGFR2 at 24 hours post treatment.||||||0.2163|||||||one-sample Wilcoxon signed rank test|||||||0.2163
71781813|NCT02516046|143063011|OTHER||Fleiss' kappa|0.8|||||TWO_SIDED|95.0|0.74|0.86||||||Inter-reader agreement analysis using Fleiss' kappa. The hypothesis tested was that the observed kappa values were ≥0.64 and the lower bound of the 2-sided 95% CIs were ≥0.55 for the inter-reader agreement among readers.||0.86|0.74|
71781814|NCT00114530|143063013|SUPERIORITY|||||||0.013||||||A Data and Safety Monitoring Board reviewed 4 pre-specified futility analyses that included an ability to stop for efficacy with p\<0.0001, leaving alpha equal to 0.0496 for the primary ITT analysis of the GRCS at 54 months post-randomization.|Wilcoxon (Mann-Whitney)|||||||0.013
71781815|NCT00114530|143063014|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71781816|NCT00114530|143063015|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71781817|NCT00114530|143063016|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71781818|NCT00114530|143063017|SUPERIORITY|||||||0.059|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.059
71781819|NCT00114530|143063017|SUPERIORITY|||||||0.06|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.06
71781820|NCT00114530|143063018|SUPERIORITY|||||||0.021|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.||||0.021
71781821|NCT00114530|143063018|SUPERIORITY|||||||0.03|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72||||0.03
71781822|NCT00114530|143063019|SUPERIORITY|||||||0.059|||||||Fisher Exact|||||||0.059
71781823|NCT00114530|143063020|SUPERIORITY|||||||0.021|||||||Fisher Exact|||||||0.021
71781824|NCT00114530|143063021|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
71781825|NCT00114530|143063022|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71781826|NCT00114530|143063023|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
71781827|NCT00114530|143063024|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71677079|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-17.0|||<|0.0001|TWO_SIDED|95.0|-21.55|-12.37||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.37|-21.55|<0.0001
71749927|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0025|TWO_SIDED|95.0|1.65|10.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.45|1.65|0.0025
71749928|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0279|TWO_SIDED|95.0|1.12|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.12|1.12|0.0279
71749929|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0114|TWO_SIDED|95.0|1.31|8.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.61|1.31|0.0114
71749930|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|7.55||||0.0001|TWO_SIDED|95.0|2.66|21.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||21.45|2.66|0.0001
71749931|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|6.41||||0.0005|TWO_SIDED|95.0|2.25|18.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||18.26|2.25|0.0005
71781828|NCT00114530|143063025|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.28
71781829|NCT00114530|143063025|SUPERIORITY|||||||0.05|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.05
71781830|NCT00114530|143063026|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.||||0.19
71781831|NCT00114530|143063026|SUPERIORITY|||||||0.02|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.||||0.02
71781832|NCT00114530|143063027|SUPERIORITY|||||||0.28|||||||Fisher Exact|||||||0.28
71781833|NCT00114530|143063028|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
71781834|NCT00114530|143063029|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
71781835|NCT00114530|143063029|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
71781836|NCT00114530|143063030|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
71781837|NCT00114530|143063030|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.002
71781838|NCT00114530|143063031|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.001
71781839|NCT00114530|143063031|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.02
71781840|NCT00114530|143063031|SUPERIORITY|||||||0.05|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.05
71781841|NCT00114530|143063031|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.1
71781842|NCT00114530|143063032|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
71781843|NCT00114530|143063032|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.||||0.003
71781844|NCT00114530|143063032|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
71781845|NCT00114530|143063032|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.||||0.07
71781846|NCT00114530|143063033|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.08
71781847|NCT00114530|143063033|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.9
71781848|NCT00114530|143063034|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.1
71781849|NCT00114530|143063034|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.6
71668304|NCT02440464|142853203|SUPERIORITY|||||||0.252||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.252
71668305|NCT02440464|142853203|SUPERIORITY|||||||0.258||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3-5 toxicities between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than toxicity treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||0.258
71749932|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0695|TWO_SIDED|95.0|0.93|6.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.02|0.93|0.0695
71668306|NCT02440464|142853205|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 6 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
71749933|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|4.83||||0.0015|TWO_SIDED|95.0|1.83|12.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.77|1.83|0.0015
71749934|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.3|8.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.28|1.30|0.0120
71749935|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.49||||0.662|TWO_SIDED|95.0|0.94|6.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.57|0.94|0.662
71781850|NCT00114530|143063035|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.02
71781851|NCT00114530|143063035|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.3
71781852|NCT00114530|143063036|SUPERIORITY|||||||0.03|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.03
71781853|NCT00114530|143063036|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.5
71781854|NCT00114530|143063037|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||0.002
71781855|NCT00114530|143063037|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.05
71781856|NCT00114530|143063038|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.||||<0.001
71781857|NCT00114530|143063038|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.||||0.01
71781858|NCT00114530|143063039|SUPERIORITY|||||||0.42|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.42
71781859|NCT00114530|143063039|SUPERIORITY|||||||0.048|||||||Chi-squared|||CHF requiring clinical treatment||||0.048
71781860|NCT00114530|143063039|SUPERIORITY|||||||0.51|||||||Chi-squared|||Clinically significant pericardial effusion||||0.51
71781861|NCT00114530|143063040|SUPERIORITY|||||||0.46|||||||Chi-squared|||Development of new or worsening arrhythmias||||0.46
71781862|NCT00114530|143063040|SUPERIORITY|||||||0.042|||||||Chi-squared|||CHF requiring clinical treatment||||0.042
71781863|NCT00114530|143063040|SUPERIORITY|||||||0.15|||||||Chi-squared|||Clinically significant pericardial effusion||||0.15
71781864|NCT00114530|143063041|SUPERIORITY|||||||0.026|||||||Chi-squared|||||||0.026
71781865|NCT00114530|143063042|SUPERIORITY|||||||0.022|||||||Chi-squared|||||||0.022
71781866|NCT00114530|143063043|SUPERIORITY|||||||0.71|||||||Chi-squared|||||||0.71
71781867|NCT00114530|143063044|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
71781868|NCT00114530|143063045|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
71781869|NCT00114530|143063046|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71781870|NCT00114530|143063047|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71781871|NCT00114530|143063048|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71781872|NCT00114530|143063049|SUPERIORITY||||||<|0.001|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||<0.001
71781873|NCT00114530|143063049|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.61, Probably related = 0.57, Definitely related = 0.52|||||
71781874|NCT00114530|143063049|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.17, Probably related = 0.09, Definitely related = 0.04|||||
71781875|NCT00114530|143063051|SUPERIORITY|||||||0.7|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.||||||0.7
71668307|NCT02440464|142853205|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 12 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
71781876|NCT00114530|143063051|SUPERIORITY||Person-Time (Years)|174.4|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.76|||||
71781877|NCT00114530|143063051|SUPERIORITY||Person-Time (Years)|141.3|||||TWO_SIDED||||||||The Person-Time (P-T) rate (events/P-T) is 0.80|||||
71668308|NCT02440464|142853205|SUPERIORITY|||||||1||||||Statistical significance was determined using a pre-specified one-sided threshold of 0.05.|Z test|||The null hypothesis is that there is no difference in the proportions of participants with Grade 3 infections between the Ixazomib and Placebo arms during 18 months post-randomization, with death from a cause other than infection treated as a competing risk. Cumulative incidences are estimated at 6, 12 and 18 months post randomization using Aalen-Johansen estimators for each treatment group. Comparison of cumulative incidence between treatment arms was done using a Z test at fixed time points.||||1.0
71781878|NCT00365508|143063055|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||a priori threshold for statistical significance|Chi-squared|||Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.||||.05
71781879|NCT05248867|143063070|SUPERIORITY||Rate Difference|59.3|||<|0.0001|TWO_SIDED|95.0|54.7|63.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||63.9|54.7|<0.0001
71835387|NCT02412748|143175719|SUPERIORITY|||||||0.557|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.557
71781880|NCT05248867|143063071|SUPERIORITY||Rate Difference|60.2|||<|0.0001|TWO_SIDED|95.0|54.9|65.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.4|54.9|<0.0001
71781881|NCT05248867|143063072|SUPERIORITY||Rate Difference|71.4|||<|0.0001|TWO_SIDED|95.0|66.5|76.2||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.2|66.5|<0.0001
71781882|NCT05248867|143063077|SUPERIORITY||Rate Difference|72.5|||<|0.0001|TWO_SIDED|95.0|67.4|77.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||77.6|67.4|<0.0001
71781883|NCT05248867|143063078|SUPERIORITY||Rate Difference|41.9|||<|0.0001|TWO_SIDED|95.0|34.5|49.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||49.3|34.5|<0.0001
71781884|NCT05248867|143063079|SUPERIORITY||Rate Difference|69.5|||<|0.0001|TWO_SIDED|95.0|63.7|75.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||75.3|63.7|<0.0001
71835388|NCT02412748|143175720|SUPERIORITY|||||||0.681|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.681
71835389|NCT02412748|143175721|SUPERIORITY|||||||0.389|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.389
71781885|NCT05248867|143063080|SUPERIORITY||Rate Difference|58.2|||<|0.0001|TWO_SIDED|95.0|51.3|65.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||65.0|51.3|<0.0001
71781886|NCT05248867|143063081|SUPERIORITY||Rate Difference|30.1|||<|0.0001|TWO_SIDED|95.0|25.2|35.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||35.1|25.2|<0.0001
71749936|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1019|TWO_SIDED|95.0|0.85|5.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.80|0.85|0.1019
71749937|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0023|TWO_SIDED|95.0|1.83|16.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.18|1.83|0.0023
71749938|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|7.33||||0.0015|TWO_SIDED|95.0|2.15|25.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||25.02|2.15|0.0015
71749939|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.78||||0.238|TWO_SIDED|95.0|0.68|4.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.66|0.68|0.2380
71749940|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.61||||0.012|TWO_SIDED|95.0|1.33|9.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.81|1.33|0.0120
71749941|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.25||||0.091|TWO_SIDED|95.0|0.88|5.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.77|0.88|0.0910
71749942|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.93||||0.1926|TWO_SIDED|95.0|0.72|5.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.18|0.72|0.1926
71749943|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1017|TWO_SIDED|95.0|0.85|6.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.15|0.85|0.1017
71749944|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0153|TWO_SIDED|95.0|1.29|11.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.45|1.29|0.0153
71749945|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|7.52||||0.0034|TWO_SIDED|95.0|1.95|28.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||28.98|1.95|0.0034
71749946|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4539|TWO_SIDED|95.0|0.55|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.76|0.55|0.4539
71749947|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.03||||0.0327|TWO_SIDED|95.0|1.1|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.40|1.10|0.0327
71749948|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0555|TWO_SIDED|95.0|0.98|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.30|0.98|0.0555
71749949|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3505|TWO_SIDED|95.0|0.58|4.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.67|0.58|0.3505
71749950|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.92||||0.0265|TWO_SIDED|95.0|1.17|13.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.11|1.17|0.0265
71749951|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0174|TWO_SIDED|95.0|1.32|17.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||17.32|1.32|0.0174
71781887|NCT05248867|143063082|SUPERIORITY||Rate Difference|35.7|||<|0.0001|TWO_SIDED|95.0|30.5|40.9||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||40.9|30.5|<0.0001
71781888|NCT05248867|143063083|SUPERIORITY||Rate Difference|52.6|||<|0.0001|TWO_SIDED|95.0|45.2|60.0||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||60.0|45.2|<0.0001
71668309|NCT04688671|142853216|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.302||0.5605|TWO_SIDED|90.0|-0.32|0.68|||Mixed Models Analysis|||||0.68|-0.32|0.5605
71668310|NCT01525329|142853226|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.007|||||||t-test, 2 sided|||||||< 0.007
71749952|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|8.95||||0.0075|TWO_SIDED|95.0|1.8|44.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||44.61|1.80|0.0075
71668311|NCT01525329|142853226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.080
71668312|NCT01525329|142853227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71668313|NCT01525329|142853227|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71749953|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1228|TWO_SIDED|95.0|0.78|7.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.68|0.78|0.1228
71781889|NCT05248867|143063084|SUPERIORITY||Rate Difference|58.6|||<|0.0001|TWO_SIDED|95.0|51.1|66.1||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||66.1|51.1|<0.0001
71668314|NCT04055740|142853229|SUPERIORITY|||||||0.2201|||||||Spearman Correlation Coefficient|This test measures correlation of avg ILA grade per patient with total time of lead extraction. Average ILA grade of all patients in outcome measures.||H0: rho = 0 Spearman correlation coefficient calculated between average ILA grade and total time of lead extraction||||0.2201
71668315|NCT04055740|142853229|SUPERIORITY|||||||0.5157|||||||Spearman Correlation Coefficient|This measures correlation of avg ILA grade per patient with total laser pulsations used for extraction. Avg ILA grade of patients in outcome measures.||H0: rho = 0 Spearman Correlation coefficient calculated between average ILA grades and laser pulsations||||0.5157
71668316|NCT02414958|142853231|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||Mixed effect Model Repeated Measures||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
71668317|NCT02414958|142853231|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.66|-0.41|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.41|-0.66|<0.0001
71749954|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0431|TWO_SIDED|95.0|1.04|10.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.38|1.04|0.0431
71749955|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0851|TWO_SIDED|95.0|0.87|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.35|0.87|0.0851
71781890|NCT05248867|143063085|SUPERIORITY||Rate Difference|42.5|||<|0.0001|TWO_SIDED|95.0|34.4|50.6||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.6|34.4|<0.0001
71835390|NCT02412748|143175722|SUPERIORITY|||||||0.846|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.846
71835391|NCT02412748|143175723|SUPERIORITY|||||||0.871|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.871
71668318|NCT02414958|142853232|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|97.5|-0.65|-0.4|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.40|-0.65|<0.0001
71668319|NCT02414958|142853232|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|97.5|-0.64|-0.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements||-0.39|-0.64|<0.0001
71835392|NCT02412748|143175724|SUPERIORITY|||||||0.986|||||||ANCOVA|||Data were analyzed using a 3 × 2 repeated measures analysis of covariance (RM-ANCOVA) with 3 assessments crossed with two treatment conditions (BBTF and FLP). Five variables were included as covariates: father's age, father's highest level of education, number of members in father's social network, number of adults in the household, and sex of the target child. The effect of interest was the condition x time interaction.||||.986
71749956|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4726|TWO_SIDED|95.0|0.53|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.99|0.53|0.4726
71749957|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1289|TWO_SIDED|95.0|0.79|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.67|0.79|0.1289
71749958|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.39||||0.04|TWO_SIDED|95.0|1.06|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.84|1.06|0.0400
71749959|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|8.22||||0.0097|TWO_SIDED|95.0|1.67|40.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||40.55|1.67|0.0097
71749960|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.97||||0.226|TWO_SIDED|95.0|0.66|5.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.94|0.66|0.2260
71749961|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|8.63||||0.0031|TWO_SIDED|95.0|2.07|35.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||35.96|2.07|0.0031
71749962|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|10.16||||0.0043|TWO_SIDED|95.0|2.07|49.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||49.90|2.07|0.0043
71749963|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5571|TWO_SIDED|95.0|0.47|4.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.04|0.47|0.5571
71749964|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1911|TWO_SIDED|95.0|0.69|6.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.59|0.69|0.1911
71749965|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1101|TWO_SIDED|95.0|0.8|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.41|0.80|0.1101
71749966|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|6.86||||0.0199|TWO_SIDED|95.0|1.36|34.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||34.74|1.36|0.0199
71749967|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.96||||0.26|TWO_SIDED|95.0|0.61|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.33|0.61|0.2600
71749968|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|8.93||||0.009|TWO_SIDED|95.0|1.73|46.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||46.19|1.73|0.0090
71749969|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|17.22||||0.0089|TWO_SIDED|95.0|2.04|145.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||145.2|2.04|0.0089
71749970|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8966|TWO_SIDED|95.0|0.36|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.19|0.36|0.8966
71749971|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5031|TWO_SIDED|95.0|0.48|4.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.51|0.48|0.5031
71835393|NCT02412748|143175725|SUPERIORITY|||||||0.791|||||||ANCOVA|||||||.791
71835394|NCT02412748|143175726|SUPERIORITY|||||||0.583|||||||ANCOVA|||||||.583
71835395|NCT02412748|143175727|SUPERIORITY|||||||0.851|||||||ANCOVA|||||||.851
71835396|NCT03069313|143175729|OTHER|Paired t-test|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71835397|NCT03069313|143175730|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71835398|NCT03069313|143175731|OTHER|This analysis is comparing SWB before and after treatment.||||||0.133|||||||t-test, 2 sided|||||||0.133
71835399|NCT03069313|143175731|OTHER|||||||0.056|||||||t-test, 2 sided|||This analysis is comparing EWB before and after treatment.||||0.056
71668320|NCT02414958|142853233|SUPERIORITY||Adjusted Rate Ratio (%)|0.744||||0.0623|TWO_SIDED|97.75|0.518|1.069|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.069|0.518|0.0623
71891600|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||-0.240|-2.521|0.0177
71668321|NCT02414958|142853233|SUPERIORITY||Adjusted Rate Ratio (%)|0.726||||0.048|TWO_SIDED|97.75|0.502|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset||1.501|0.502|0.0480
71668322|NCT02414958|142853233|SUPERIORITY||Adjusted Rate Ratio (%)|0.774||||0.0972|TWO_SIDED|95.0|0.572|1.048||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.048|0.572|0.0972
71668323|NCT02414958|142853233|SUPERIORITY||Adjusted Rate Ratio (%)|0.782||||0.118|TWO_SIDED|97.75|0.575|1.064||Negative binomial model|MMRM||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.064|0.575|0.1180
71668324|NCT02414958|142853234|SUPERIORITY||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|99.75|-3.57|-1.8|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.80|-3.57|<0.0001
71668325|NCT02414958|142853234|SUPERIORITY||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|99.75|-4.15|-2.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.39|-4.15|<0.0001
71668326|NCT02414958|142853235|SUPERIORITY||Mean Difference (Final Values)|11.86|||<|0.0001|TWO_SIDED|99.75|8.78|14.93|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||14.93|8.78|<0.0001
71668327|NCT02414958|142853235|SUPERIORITY||Mean Difference (Final Values)|12.87|STANDARD_ERROR_OF_MEAN|1.01|<|0.0001|TWO_SIDED|99.75|9.81|15.93|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|||15.93|9.81|<0.0001
71749972|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2603|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.92|0.59|0.2603
71749973|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.16||||0.2447|TWO_SIDED|95.0|0.59|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.88|0.59|0.2447
71749974|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.64||||0.4239|TWO_SIDED|95.0|0.49|5.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.55|0.49|0.4239
71749975|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|11.72||||0.024|TWO_SIDED|95.0|1.38|99.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||99.35|1.38|0.0240
71749976|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1457|TWO_SIDED|95.0|0.72|9.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.41|0.72|0.1457
71835400|NCT03069313|143175731|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing PWB before and after treatment.||||<0.0001
71835401|NCT03069313|143175731|OTHER|||||||0.09|||||||t-test, 2 sided|||This analysis is comparing FWB before and after treatment.||||0.09
71835402|NCT03069313|143175731|OTHER||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing ESS before and after treatment.||||<0.0001
71835403|NCT01872078|143175739|SUPERIORITY_OR_OTHER||Ratio (%)|87.04|||||TWO_SIDED|95.0|58.52|129.47||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||129.47|58.52|
71835404|NCT01872078|143175739|SUPERIORITY_OR_OTHER||Ratio (%)|78.76|||||TWO_SIDED|95.0|53.41|116.16||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||116.16|53.41|
71781891|NCT05248867|143063086|SUPERIORITY||Rate Difference|70.0|||<|0.0001|TWO_SIDED|95.0|63.7|76.3||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||76.3|63.7|<0.0001
71891601|NCT01431287|143304574|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||1.109|-1.164|0.9624
71668328|NCT02414958|142853236|SUPERIORITY||Mean Difference (Final Values)|-16.92|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-22.04|-11.81|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-11.81|-22.04|<0.0001
71749977|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.34|3.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.38|0.34|0.9000
71749978|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7644|TWO_SIDED|95.0|0.39|3.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.64|0.39|0.7644
71749979|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2245|TWO_SIDED|95.0|0.6|8.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.67|0.60|0.2245
71749980|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0475|TWO_SIDED|95.0|1.02|27.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||27.40|1.02|0.0475
71749981|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.15||||0.2569|TWO_SIDED|95.0|0.57|8.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.07|0.57|0.2569
71749982|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|9.32||||0.0412|TWO_SIDED|95.0|1.09|79.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||79.44|1.09|0.0412
71749983|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1201|TWO_SIDED|95.0|0.76|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.61|0.76|0.1201
71749984|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3814|TWO_SIDED|95.0|0.53|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.23|0.53|0.3814
71749985|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8549|TWO_SIDED|95.0|0.38|3.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.23|0.38|0.8549
71749986|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.77||||0.1274|TWO_SIDED|95.0|0.75|10.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.24|0.75|0.1274
71749987|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0703|TWO_SIDED|95.0|0.9|15.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.01|0.90|0.0703
71749988|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1821|TWO_SIDED|95.0|0.66|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.76|0.66|0.1821
71749989|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|12.96||||0.0187|TWO_SIDED|95.0|1.53|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||109.5|1.53|0.0187
71749990|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|4.18||||0.0458|TWO_SIDED|95.0|1.03|17.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||17.00|1.03|0.0458
71891602|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.862|0.329|<0.0001
71781892|NCT05248867|143063094|SUPERIORITY||Rate Difference|48.8|||<|0.0001|TWO_SIDED|95.0|42.2|55.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||55.4|42.2|<0.0001
71781893|NCT05248867|143063095|SUPERIORITY||Rate Difference|44.2|||<|0.0001|TWO_SIDED|95.0|38.0|50.4||P-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by investigator site, toxin use history (for aesthetic purposes), and baseline Facial Wrinkle Scale score at maximum frown after using multiple imputation for missing data.|Cochran-Mantel-Haenszel||Difference: AGN-151586 - Placebo|AGN-151586 vs Placebo||50.4|38.0|<0.0001
71781894|NCT01064310|143063097|SUPERIORITY_OR_OTHER||Percentage of participants|49.26|||<|0.001|TWO_SIDED|90.0|37.0|61.5||The p value indicates the difference in preference for pazopanib versus sunitinib treatment|Prescotts test||The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.|||61.5|37.0|<0.001
71781895|NCT05544734|143063141|SUPERIORITY||Median Difference (Final Values)|-0.3||||0.69|TWO_SIDED|95.0|-1.85|1.25|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = baseline to postoperative day 2) minus Non-Hydrocodone group mean change (i.e., change = baseline to postoperative day 2).|||1.25|-1.85|0.69
71891603|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.907|0.373|<0.0001
71891604|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.690|0.156|0.0019
71891605|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.712|0.179|0.0011
71781896|NCT05544734|143063142|SUPERIORITY||Median Difference (Final Values)|2.3||||0.62|TWO_SIDED|95.0|-7.25|11.85|||t-test, 2 sided||Direction = Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6) minus Non-Hydrocodone group mean change (i.e., change = postoperative day 3 to postoperative day 6).|||11.85|-7.25|0.62
71781897|NCT01218113|143063227|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|0.801|||||TWO_SIDED|97.5|0.553|1.162|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.||1.162|0.553|
71781898|NCT01218113|143063227|NON_INFERIORITY|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|1.184|||||TWO_SIDED|97.5|0.816|1.717|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||1.717|0.816|
71781899|NCT01218113|143063228|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D\_HIV Group - Control Group) is below 0.|Mean Difference|-0.096|||||TWO_SIDED|97.5|-0.257|0.065|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.065|-0.257|
71781900|NCT01218113|143063228|NON_INFERIORITY|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D\_HIV Group - Control Group) is below 0.|Mean Difference|0.073|||||TWO_SIDED|97.5|-0.088|0.235|||Repeated-measures mixed model|||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.||0.235|-0.088|
71781901|NCT00967668|143063293|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|Linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables||All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.||||<0.05
71781902|NCT01637935|143063302|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1||||||95.0|0.92|1.31||||||Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.||1.31|0.92|
71781903|NCT01637935|143063302|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.06||||||95.0|0.89|1.26||||||Fully adjusted adding the proteinuria testing variable.||1.26|0.89|
71668329|NCT02414958|142853236|SUPERIORITY||Mean Difference (Final Values)|-19.04|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|99.75|-24.13|-13.95|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.||-13.95|-24.13|<0.0001
71668330|NCT02414958|142853237|SUPERIORITY||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.121|-0.063|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.063|-0.121|<0.0001
71668331|NCT02414958|142853237|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|99.75|-0.119|-0.062|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.062|-0.119|<0.0001
71668332|NCT02414958|142853238|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0397|TWO_SIDED|99.75|-5.2|1.0|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||1.0|-5.2|0.0397
71668333|NCT02414958|142853238|SUPERIORITY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|1.0||0.0003|TWO_SIDED|99.75|-6.8|-0.6|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.6|-6.8|0.0003
71668334|NCT02414958|142853238|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.7||0.0457|TWO_SIDED|99.75|-2.7|0.0||Nominal p-value|MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.0|-2.7|0.0457
71781904|NCT01637935|143063303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||||95.0|0.71|1.12||||||Time since starting pioglitazone \<4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.12|0.71|
71781905|NCT01637935|143063303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||||95.0|0.93|1.59||||||Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.59|0.93|
71781906|NCT01637935|143063303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||||95.0|0.83|1.75||||||Time since starting pioglitazone \>8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.75|0.83|
71781907|NCT01637935|143063304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||||95.0|0.68|1.16||||||Duration of therapy \<1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.68|
71781908|NCT01637935|143063304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||||95.0|0.8|1.33||||||Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.33|0.80|
71835405|NCT01872078|143175739|SUPERIORITY_OR_OTHER||Ratio (%)|47.99|||||TWO_SIDED|95.0|32.73|70.36||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%||70.36|32.73|
71835406|NCT02119650|143175770|OTHER||Hazard Ratio (HR)|0.877||||0.7562|TWO_SIDED|80.0|0.509|1.51|||Log Rank|The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).||||1.51|0.509|0.7562
71835407|NCT04924062|143175787|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.51|1.08|||||HR=Arm A/Arm B|||1.08|0.51|
71835408|NCT04924062|143175788|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.58|1.19|||||HR=Arm A/Arm B|||1.19|0.58|
71835409|NCT04924062|143175789|OTHER||Difference in Percentages|7.1|||||TWO_SIDED|95.0|-7.5|21.6|||||Difference=Arm A minus Arm B|||21.6|-7.5|
71668335|NCT02414958|142853238|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.7||0.0006|TWO_SIDED|99.75|-4.3|-0.3|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.3|-4.3|0.0006
71749991|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6806|TWO_SIDED|95.0|0.41|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.89|0.41|0.6806
71781909|NCT01637935|143063304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||||95.0|0.87|1.54||||||Duration of therapy \>4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.54|0.87|
71749992|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.15||||0.809|TWO_SIDED|95.0|0.38|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.45|0.38|0.8090
71749993|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2352|TWO_SIDED|95.0|0.6|8.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.26|0.60|0.2352
71749994|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.04||||0.1231|TWO_SIDED|95.0|0.74|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.50|0.74|0.1231
71749995|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1445|TWO_SIDED|95.0|0.7|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||11.76|0.70|0.1445
71749996|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|12.03||||0.023|TWO_SIDED|95.0|1.41|102.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||102.7|1.41|0.0230
71749997|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0801|TWO_SIDED|95.0|0.86|14.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||14.36|0.86|0.0801
71749998|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.63||||0.4152|TWO_SIDED|95.0|0.5|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.32|0.50|0.4152
71749999|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.7||||0.3845|TWO_SIDED|95.0|0.51|5.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.65|0.51|0.3845
71750000|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1864|TWO_SIDED|95.0|0.65|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.39|0.65|0.1864
71750001|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.06||||0.01268|TWO_SIDED|95.0|0.73|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.86|0.73|0.01268
71781910|NCT01637935|143063305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.69|1.16||||||Cumulative dose 1-14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.16|0.69|
71835410|NCT02349412|143175811|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.104|TWO_SIDED|95.0|-0.67|7.13|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.13|-0.67|0.104
71835411|NCT02349412|143175812|SUPERIORITY||Mean Difference (Final Values)|3.12||||0.188|TWO_SIDED|95.0|-1.54|7.77|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score||||7.77|-1.54|0.188
71835412|NCT02349412|143175813|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.884|TWO_SIDED|95.0|-0.94|2.09|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score||||2.09|-0.94|0.884
71835413|NCT02349412|143175814|SUPERIORITY||Mean Difference (Final Values)|-0.81||||0.033|TWO_SIDED|95.0|-1.54|-0.07|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score||||-0.07|-1.54|0.033
71835414|NCT02349412|143175815|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
71750002|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.8||||0.16|TWO_SIDED|95.0|0.67|11.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.76|0.67|0.1600
71750003|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0317|TWO_SIDED|95.0|1.17|32.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||32.11|1.17|0.0317
71750004|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0709|TWO_SIDED|95.0|0.89|15.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||15.53|0.89|0.0709
71750005|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.6||||0.4533|TWO_SIDED|95.0|0.47|5.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.41|0.47|0.4533
71750006|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7053|TWO_SIDED|95.0|0.24|2.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||2.60|0.24|0.7053
71750007|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3677|TWO_SIDED|95.0|0.49|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.99|0.49|0.3677
71750008|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.24||||0.735|TWO_SIDED|95.0|0.35|4.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||4.40|0.35|0.7350
71750009|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.37||||0.6443|TWO_SIDED|95.0|0.36|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.15|0.36|0.6443
71750010|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4865|TWO_SIDED|95.0|0.43|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.43|0.4865
71750011|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.52||||0.1628|TWO_SIDED|95.0|0.69|9.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.27|0.69|0.1628
71750012|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.79||||0.6935|TWO_SIDED|95.0|0.24|2.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.57|0.24|0.6935
71750013|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9753|TWO_SIDED|95.0|0.32|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.28|0.32|0.9753
71781911|NCT01637935|143063305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.85|1.42||||||Cumulative dose 14001-40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.42|0.85|
71781912|NCT01637935|143063305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||||95.0|0.79|1.44||||||Cumulative dose \>40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.||1.44|0.79|
71781913|NCT00709761|143063307|SUPERIORITY_OR_OTHER||percentage of participants|53.0||||||95.0|40.7|66.0|||||The estimation parameter represents the percentage of participants experiencing either a CR or a PR.|||66.0|40.7|
71781914|NCT01918774|143063319|OTHER|Pre-post analysis comparing weeks worked in the 6 months preceding baseline and the 6 month study follow-up.|||||<|0.001||||||A priori threshold of significance was p\<.05|within groups t-test|||||||<.001
71781915|NCT01135420|143063334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
71781916|NCT00717197|143063341|SUPERIORITY_OR_OTHER||Percentage|21.7|STANDARD_ERROR_OF_MEAN|7.27|||TWO_SIDED|95.0|7.46|43.7||||||||43.7|7.46|
71781917|NCT03311724|143063350|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
71781918|NCT03311724|143063350|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||||-1.7|-2.8|<0.001
71781919|NCT03311724|143063350|SUPERIORITY||Mean Difference (Final Values)|-2.0|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Mixed Models Analysis|||||-1.4|-2.5|<0.001
71781920|NCT03311724|143063351|SUPERIORITY||Odds Ratio (OR)|56.54|||<|0.001|TWO_SIDED|95.0|9.43|338.97|||Regression, Logistic|||||338.97|9.43|<0.001
71781921|NCT03311724|143063351|SUPERIORITY||Odds Ratio (OR)|183.48|||<|0.001|TWO_SIDED|95.0|22.0|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|22.0|<0.001
71668336|NCT05767905|142853240|OTHER||ratio|108.49|||||TWO_SIDED|90.0|100.55|117.05|||Mixed Models Analysis|"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment and Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment.||117.05|100.55|
71668337|NCT05767905|142853240|OTHER||ratio|106.16|||||TWO_SIDED|90.0|98.39|114.54|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||114.54|98.39|
71781922|NCT03311724|143063351|SUPERIORITY||Odds Ratio (OR)|157.54|||<|0.001|TWO_SIDED|95.0|21.63|999.0|||Regression, Logistic||"Maximum confidential interval is \>999"|||999|21.63|<0.001
71781923|NCT03311724|143063352|SUPERIORITY||Mean Difference (Final Values)|-48.5|||<|0.001|TWO_SIDED|95.0|-70.6|-26.3|||Mixed Models Analysis|||||-26.3|-70.6|<0.001
71781924|NCT03311724|143063352|SUPERIORITY||Mean Difference (Final Values)|-58.0|||<|0.001|TWO_SIDED|95.0|-80.7|-35.2|||Mixed Models Analysis|||||-35.2|-80.7|<0.001
71781925|NCT03311724|143063352|SUPERIORITY||Mean Difference (Final Values)|-61.9|||<|0.001|TWO_SIDED|95.0|-84.6|-39.2|||Mixed Models Analysis|||||-39.2|-84.6|<0.001
71668338|NCT05767905|142853240|OTHER||ratio|228.99|||||TWO_SIDED|90.0|178.67|293.48|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||293.48|178.67|
71781926|NCT03311724|143063353|SUPERIORITY||Mean Difference (Final Values)|-4.8|||<|0.001|TWO_SIDED|95.0|-7.1|-2.6|||Mixed Models Analysis|||||-2.6|-7.1|<0.001
71781927|NCT03311724|143063353|SUPERIORITY||Mean Difference (Final Values)|-5.0|||<|0.001|TWO_SIDED|95.0|-7.2|-2.7|||Mixed Models Analysis|||||-2.7|-7.2|<0.001
71668339|NCT05767905|142853240|OTHER||ratio|207.19|||||TWO_SIDED|90.0|164.41|261.09||||||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||261.09|164.41|
71781928|NCT03311724|143063353|SUPERIORITY||Mean Difference (Final Values)|-5.2|||<|0.001|TWO_SIDED|95.0|-7.5|-2.9|||Mixed Models Analysis|||||-2.9|-7.5|<0.001
71781929|NCT03311724|143063354|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.075|TWO_SIDED|95.0|-4.7|0.2|||Mixed Models Analysis|||||0.2|-4.7|0.075
71781930|NCT03311724|143063354|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.065
71781931|NCT03311724|143063354|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.065|TWO_SIDED|95.0|-4.9|0.2|||Mixed Models Analysis|||||0.2|-4.9|0.065
71781932|NCT03156543|143063395|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Analysis was based on the participants who were positive for C. acnes.||||0.004
71781933|NCT00674700|143063397|SUPERIORITY_OR_OTHER|||||||0.0066||||||main effects = treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.0066
71781934|NCT00674700|143063397|SUPERIORITY_OR_OTHER|||||||0.015||||||main effects= treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA|||||||0.015
71781935|NCT00674700|143063398|SUPERIORITY_OR_OTHER|||||||0.0086|||||||ANCOVA|||||||0.0086
71781936|NCT00674700|143063398|SUPERIORITY_OR_OTHER|||||||0.0095|||||||ANCOVA|||||||0.0095
71781937|NCT03535844|143063409|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|independent t-test of change values||||||0.49
71781938|NCT03535844|143063409|SUPERIORITY|||||||0.5672|||||||t-test, 1 sided|Paired t-test (Week 0 and Week 16)||||||0.5672
71781939|NCT03535844|143063409|SUPERIORITY|||||||0.788|||||||t-test, 2 sided|Paired t-test of change values||||||0.788
71781940|NCT03535844|143063410|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|independent t-test of change values||||||0.67
71781941|NCT03535844|143063410|SUPERIORITY|||||||0.8203|||||||t-test, 2 sided|Paired t-test of change values||||||0.8203
71781942|NCT03535844|143063410|SUPERIORITY|||||||0.3882|||||||t-test, 2 sided|Paired t-test of change values||||||0.3882
71781943|NCT03535844|143063411|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|independent t-test of change values||||||0.08
71781944|NCT03535844|143063412|SUPERIORITY|||||||0.7162|||||||t-test, 2 sided|independent t-test of change values||||||0.7162
71781945|NCT03535844|143063412|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||0.07
71781946|NCT03535844|143063412|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values||||||<0.05
71781947|NCT03535844|143063413|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Independent t-test of change values||||||<0.05
71781948|NCT03535844|143063414|SUPERIORITY|||||||0.4855|||||||t-test, 2 sided|Independent t-test of change triglyceride values||||||0.4855
71781949|NCT03535844|143063414|SUPERIORITY|||||||0.1393|||||||t-test, 2 sided|Independent t-test of change total cholesterol values||||||0.1393
71781950|NCT03535844|143063414|SUPERIORITY|||||||0.2221|||||||t-test, 2 sided|Independent t-test of change LDL cholesterol values||||||0.2221
71781951|NCT03535844|143063414|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|Independent t-test of change HDL cholesterol values||||||0.078
71781952|NCT03535844|143063414|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||<0.05
71781953|NCT03535844|143063414|SUPERIORITY|||||||0.7261|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values||||||0.7261
71781954|NCT03535844|143063415|SUPERIORITY|||||||0.1951|||||||t-test, 2 sided|Independent t-test of systolic blood pressure change values||||||0.1951
71781955|NCT03535844|143063415|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|Independent t-test of diastolic blood pressure change values||||||0.916
71781956|NCT03535844|143063416|SUPERIORITY|||||||0.9882|||||||t-test, 2 sided|independent t-test of malondialdehyde change values||||||0.9882
71781957|NCT03535844|143063417|SUPERIORITY|||||||0.4408|||||||t-test, 2 sided|Independent t-test of body fat % change values||||||0.4408
71781958|NCT03535844|143063418|SUPERIORITY|||||||0.1487|||||||t-test, 2 sided|Independent t-test of change values||||||0.1487
71781959|NCT03535844|143063419|SUPERIORITY|||||||0.9135|||||||t-test, 2 sided|Independent t-test of change values||||||0.9135
71781960|NCT03535844|143063420|SUPERIORITY|||||||0.5859|||||||t-test, 2 sided|Independent t-test of change values||||||0.5859
71781961|NCT03535844|143063421|SUPERIORITY|||||||0.9379|||||||t-test, 2 sided|Independent t-test of change values||||||0.9379
71781962|NCT03535844|143063422|SUPERIORITY|||||||0.9717|||||||t-test, 2 sided|t-test of change values||||||0.9717
71781963|NCT03535844|143063425|SUPERIORITY|||||||0.7052|||||||t-test, 2 sided|Independent t-test of change values||||||0.7052
71781964|NCT03535844|143063425|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|Paired t-test between Week 0 and Week 16 endothelin-1 concentrations||||||0.07
71781965|NCT03535844|143063425|SUPERIORITY|||||||0.005||||||Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|t-test, 2 sided|||||||0.005
71781966|NCT03535844|143063426|SUPERIORITY|||||||0.9426||||||Independent t-test of change values|t-test, 2 sided|||||||0.9426
71668340|NCT05767905|142853240|OTHER||ratio|102.19|||||TWO_SIDED|90.0|95.55|109.3|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment||109.30|95.55|
71781967|NCT01867424|143063457|OTHER||Median of Differences|0.43||||0.0008|TWO_SIDED|||||Median of difference in CER: All cases.|Wilcoxon Test||The relative difference between groups is based on the change from baseline values to the values collected at each of the three time points.|Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) in prostate cancers upon injection of Eovist. Subgroup analysis of CER in (i) Advanced Disease and (ii) Localized Disease||||0.0008
71781968|NCT01867424|143063457|OTHER||Median of Differences|0.42||||0.0039|TWO_SIDED|||||Median of difference in CER: Advanced Disease Cases.|Wilcoxon Test|||||||0.0039
71781969|NCT01867424|143063457|OTHER||Median of Differences|0.475||||0.084|TWO_SIDED|||||Median of difference in CER: Local Disease Cases.|Wilcoxon Test|||||||0.084
71781970|NCT01867424|143063457|OTHER||Median Difference CER|0.17||||0.25|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.25
71781971|NCT01867424|143063457|OTHER||Median Difference CER|0.27||||0.1602|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.1602
71781972|NCT01867424|143063457|OTHER||Median Difference CER|0.29||||0.0078|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection.||||0.0078
71781973|NCT01867424|143063457|OTHER||Median Difference CER|0.34||||0.0039|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection.||||0.0039
71781974|NCT01867424|143063457|OTHER||Median Difference CER|0.27||||0.0046|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 40 minutes after Eovist injection; Total cases.||||0.0046
71781975|NCT01867424|143063457|OTHER||Median Difference CER|0.33||||0.0017|TWO_SIDED||||||Wilcoxon Test|||Analysis of CER from baseline to 60 minutes after Eovist injection; Total cases.||||0.0017
71781976|NCT01867424|143063459|OTHER||Spearman r|-0.137||||0.5761|TWO_SIDED|95.0|-0.5665|0.3511|||Nonparametric Spearman correlation|The calculation of Spearman correlation is between baseline PSA and CER at 20 minutes post Eovist injection.||Null Hypothesis: There is no significant difference in contrast enhancement ratio (CER) with Eovist injection based on baseline Prostate-specific antigen (PSA) levels at 20-minute timepoint.||0.3511|-0.5665|0.5761
71781977|NCT01867424|143063459|OTHER||Spearman r|-0.257||||0.3033|TWO_SIDED|95.0|-0.6549|0.2526|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 40 minutes post Eovist injection.||0.2526|-0.6549|0.3033
71781978|NCT01867424|143063459|OTHER||Spearman r|-0.2861||||0.2351|TWO_SIDED|95.0|-0.6634|0.2071|||nonparametric Spearman correlation|||Analyses include calculation of Spearman correlation between baseline Prostate-specific antigen (PSA) and CER at 60 minutes post Eovist injection.||0.2071|-0.6634|0.2351
71781979|NCT01867424|143063459|OTHER||Median Difference (actual)|-0.47||||0.111|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.111
71781980|NCT01867424|143063459|OTHER||Median Difference (actual)|-0.775||||0.7738|TWO_SIDED||||||Mann Whitney|||Analyses include analysis of CER at 20 minutes after Eovist injection based on baseline Prostate-specific antigen (PSA) stratifying by PSA \< or \>/= 20ng/ml.||||0.7738
71781981|NCT01056653|143063461|SUPERIORITY_OR_OTHER||||||=|0.03|||||||ANCOVA|F(2,107)=3.48, partial n2=0.061, observed power=0.639||ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||=0.03
71781982|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.03||||||Bonferroni adjustments for multiple comparisons used|ANOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.03
71781983|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.534||||||Bonferroni adjustment for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores||||0.534
71781984|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.047|||||||ANCOVA|F(2,107)=3.145, partial n2=0.056, observed power=0.593.||ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.047
71781985|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.056||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.056
71781986|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.267||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale||||0.267
71668341|NCT05767905|142853241|OTHER||ratio|145.49|||||TWO_SIDED|90.0|121.29|174.53|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment.||174.53|121.29|
71668342|NCT05767905|142853241|OTHER||ratio|122.64|||||TWO_SIDED|90.0|102.24|147.12|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.||147.12|102.24|
71668343|NCT05767905|142853241|OTHER||ratio|284.72|||||TWO_SIDED|90.0|226.39|358.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||358.06|226.39|
71668344|NCT05767905|142853241|OTHER||ratio|327.87|||||TWO_SIDED|90.0|256.9|418.44|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.||418.44|256.90|
71668345|NCT05767905|142853241|OTHER||ratio|118.63|||||TWO_SIDED|90.0|96.36|146.06|||Mixed Models Analysis|Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means||Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment.||146.06|96.36|
71668346|NCT03762239|142853245|SUPERIORITY||Relative (percent) changes in the median|1.37||||0.52|TWO_SIDED|95.0|-2.81|5.56|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in better performance, relative to the classroom without air filter (normal air), in attention measures among adolescents in high schools.||5.56|-2.81|0.52
71781987|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|F(2,107)=3.440, partial n2=0.060, observed power=0.634||ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.036
71781988|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.036||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||0.036
71668347|NCT03762239|142853246|SUPERIORITY||Beta coefficient|0.013||||0.72|TWO_SIDED|95.0|-0.0607|0.0865|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher riskloving behavior, relative to the classroom without air filter (normal air), in the combined risk taking measures among adolescents in high schools.||0.0865|-0.0607|0.72
71668348|NCT03762239|142853247|SUPERIORITY||Beta coefficient|-0.029||||0.5|TWO_SIDED|95.0|-0.117|0.0584|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of patience, relative to the classroom without air filter (normal air), in the combined patience measures among adolescents in high schools.||0.0584|-0.1170|0.50
71750014|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7407|TWO_SIDED|95.0|0.23|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.81|0.23|0.7407
71781989|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||1||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale||||1.00
71781990|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.665|||||||ANCOVA|F(2,107)=0.409||ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.665
71781991|NCT01056653|143063461|SUPERIORITY_OR_OTHER|||||||0.732|||||||ANCOVA|F(2,107)=0.313||ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.732
71781992|NCT01056653|143063462|SUPERIORITY_OR_OTHER|||||||0.61|||||||ANCOVA|F(2,107)=0.49||ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.61
71750015|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.55||||0.4929|TWO_SIDED|95.0|0.44|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.49|0.44|0.4929
71750016|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.88||||0.8496|TWO_SIDED|95.0|0.25|3.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.15|0.25|0.8496
71750017|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|1.92||||0.3248|TWO_SIDED|95.0|0.52|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.05|0.52|0.3248
71750018|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2589|TWO_SIDED|95.0|0.59|6.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.92|0.59|0.2589
71668349|NCT03762239|142853248|SUPERIORITY||Beta coefficient|0.06||||0.13|TWO_SIDED|95.0|-0.0184|0.1394|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher level of positive reciprocity behavior, relative to the classroom without air filter (normal air), in the positive reciprocity measures among adolescents in high schools||0.1394|-0.0184|0.13
71668350|NCT03762239|142853249|SUPERIORITY||Beta coefficient|0.022||||0.58|TWO_SIDED|95.0|-0.0595|0.1035|||Regression, Linear|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher Altruism behavior, relative to the classroom without air filter (normal air), in the Altruism measures among adolescents in high schools.||0.1035|-0.0595|0.58
71781993|NCT01056653|143063462|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|F(2,107)=0.96||ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.38
71781994|NCT01056653|143063463|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|F(2,106)=2.24.||ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.11
71781995|NCT01056653|143063463|SUPERIORITY_OR_OTHER|||||||0.686|||||||ANCOVA|F(2,106)=0.379||ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.686
71781996|NCT01056653|143063463|SUPERIORITY_OR_OTHER|||||||0.121|||||||ANCOVA|F(2,106)=2.158||ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.||||0.121
71781997|NCT01847274|143063464|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.173|0.41||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.410|0.173|<0.0001
71781998|NCT01847274|143063465|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.243|0.586||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.586|0.243|<0.0001
71781999|NCT01847274|143063466|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.338|0.607||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.|||0.607|0.338|<0.0001
71782000|NCT01847274|143063467|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.412|0.783||Two-sided p-value|Log Rank|||||0.783|0.412|0.0005
71782001|NCT01847274|143063468|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.454|0.74||Two-sided P-value.|Log Rank|||||0.740|0.454|<0.0001
71782002|NCT01847274|143063469|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.268|0.561||Two-sided P-value.|Log Rank|||||0.561|0.268|<0.0001
71782003|NCT01847274|143063470|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.428|0.727||Two-sided P-value.|Log Rank|||||0.727|0.428|<0.0001
71782004|NCT01847274|143063471|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0302|TWO_SIDED|95.0|0.5|0.968||Two-sided P-value.|Log Rank|||||0.968|0.500|0.0302
71782005|NCT01847274|143063472|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0748|TWO_SIDED|95.0|0.627|1.022||Two-sided P-value.|Log Rank|||||1.022|0.627|0.0748
71782006|NCT01847274|143063473|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.358|TWO_SIDED|95.0|0.606|1.198||Two-sided P-value.|Log Rank|||||1.198|0.606|0.3580
71782007|NCT01847274|143063474|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6868|TWO_SIDED|95.0|0.813|1.369||Two-sided P-value.|Log Rank|||||1.369|0.813|0.6868
71782008|NCT01847274|143063475|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0061|TWO_SIDED|95.0|0.451|0.878||Two-sided P-value.|Log Rank|||||0.878|0.451|0.0061
71782009|NCT01847274|143063476|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1674|TWO_SIDED|95.0|0.654|1.077||Two-sided P-value.|Log Rank|||||1.077|0.654|0.1674
71782010|NCT01847274|143063493|SUPERIORITY|||||||0.7969|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.7969
71782011|NCT01847274|143063493|SUPERIORITY|||||||0.8794|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.8794
71782012|NCT01847274|143063494|SUPERIORITY|||||||0.2399|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.2399
71782013|NCT01847274|143063494|SUPERIORITY|||||||0.4584|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4584
71782014|NCT01847274|143063495|SUPERIORITY|||||||0.8566|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8566
71782015|NCT01847274|143063495|SUPERIORITY|||||||0.4705|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.4705
71782016|NCT01847274|143063496|SUPERIORITY|||||||0.8521|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.8521
71782017|NCT01847274|143063496|SUPERIORITY|||||||0.9923|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9923
71782018|NCT01847274|143063497|SUPERIORITY|||||||0.9997|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9997
71782019|NCT01847274|143063497|SUPERIORITY|||||||0.3518|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.3518
71668351|NCT03762239|142853250|SUPERIORITY||Beta coefficient|0.013||||0.89|TWO_SIDED|95.0|-0.1786|0.2049|||Ordered logistic regression|Using multiple imputation by chained equations. Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher trust, relative to the classroom without air filter (normal air), in the subjective trust measure among adolescents in high schools.||0.2049|-0.1786|0.89
71668352|NCT03762239|142853251|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5|TWO_SIDED|95.0|-0.49|0.24|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.24|-0.49|0.50
71668353|NCT03762239|142853252|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.47|TWO_SIDED|95.0|-0.2|0.1|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.|Change comparing the filter group to the non-filter group|||0.10|-0.20|0.47
71668354|NCT03762239|142853253|SUPERIORITY||Mean Difference (Final Values)|-3.38||||0.2|TWO_SIDED|95.0|-8.51|1.74|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||1.74|-8.51|0.20
71750019|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3318|TWO_SIDED|95.0|0.16|1.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.87|0.16|0.3318
71750020|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8536|TWO_SIDED|95.0|0.26|3.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.01|0.26|0.8536
71782020|NCT01847274|143063498|SUPERIORITY|||||||0.9367|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.9367
71891606|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.735|0.201|0.0006
71750021|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2817|TWO_SIDED|95.0|0.12|1.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.84|0.12|0.2817
71782021|NCT01847274|143063498|SUPERIORITY|||||||0.2502|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2502
71668355|NCT03762239|142853254|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.92|TWO_SIDED|95.0|-5.1|4.6|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||4.60|-5.10|0.92
71668356|NCT03762239|142853255|SUPERIORITY||Mean Difference (Final Values)|-1.36||||0.46|TWO_SIDED|95.0|-4.94|2.22|||Conditional linear regression|Class group as strata. Adjusted for year of birth, sex as well as average temperature, relative humidity and CO2 concentration during the experiment.||||2.22|-4.94|0.46
71750022|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.59||||0.4091|TWO_SIDED|95.0|0.17|2.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.07|0.17|0.4091
71750023|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.5||||0.3147|TWO_SIDED|95.0|0.13|1.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.93|0.13|0.3147
71782022|NCT01847274|143063499|SUPERIORITY|||||||0.5037|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5037
71782023|NCT01847274|143063499|SUPERIORITY|||||||0.164|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.1640
71668357|NCT03762239|142853256|SUPERIORITY||Beta coefficient|-0.1446||||0.232|TWO_SIDED|95.0|-0.382|0.0928|||Ordered logistic regression|Adjusted for a rich set or relevant controls. Standard errors clustered at the high school level.|Change comparing the filter group to the non-filter group|The hypothesis was that air filtration could result in higher assessment of math skills, relative to the classroom without air filter (normal air), in the self assessed math skills measure among adolescents in high schools.||0.0928|-0.3820|0.232
71782024|NCT01847274|143063500|SUPERIORITY|||||||0.9599|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.9599
71782025|NCT01847274|143063500|SUPERIORITY|||||||0.247|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2470
71782026|NCT01847274|143063501|SUPERIORITY|||||||0.5921|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Feet||||||0.5921
71782027|NCT01847274|143063501|SUPERIORITY|||||||0.7459|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.7459
71782028|NCT01847274|143063502|SUPERIORITY|||||||0.0259|||||||Pearson's Chi-squared test|||||||0.0259
71782029|NCT01847274|143063502|SUPERIORITY|||||||0.2798|||||||Pearson's Chi-squared test|Analysis for gBRCA Niraparib vs gBRCA Placebo-Hands||||||0.2798
71782030|NCT01847274|143063509|SUPERIORITY||Ratio of Least square mean|1.1|||||TWO_SIDED|90.0|0.997|1.216||||||||1.216|0.997|
71782031|NCT01847274|143063510|SUPERIORITY||Ratio of Least square mean|1.068|||||TWO_SIDED|90.0|0.978|1.166||||||||1.166|0.978|
71782032|NCT01847274|143063511|SUPERIORITY||Ratio of Least square mean|0.785|||||TWO_SIDED|90.0|0.695|0.886||||||||0.886|0.695|
71782033|NCT03727230|143063515|OTHER||||||<|0.001|||||||Chi-squared|||In this study, a single-arm clinical trial was conducted. The summarized alloanti-D rate (203/720, 28.2%; 95% CI, 19%-32%) in truly RhD-negative patients with similar mixed diseases after RhD+ RBC transfusion reported in the meta-analysis (Ji YL, et al. Vox Sang 2022; 117: 633-40) was used as the control for comparison with alloanti-D rate identified in Asian-type DEL patients after RhD+ RBC transfusion in the clinical trial.||||< 0.001
71782034|NCT04377620|143063517|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0292|TWO_SIDED|95.0|0.201|1.028|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.028|0.201|0.0292
71782035|NCT04377620|143063517|SUPERIORITY||Odds Ratio (OR)|0.42||||0.028|TWO_SIDED|95.0|0.171|1.023|||Mixed Models Analysis|logistic regression mixed model includes treatment group and ARDS severity as fixed covariates and investigational site as a random effect.||||1.023|0.171|0.0280
71782036|NCT03470441|143063530|OTHER||||||||||||||descriptive||||As little data exists on the incidence of arrhythmias that occur over an extended period of time following AMI, descriptive analysis of the primary endpoints (Arrhythmias of Interest at 48 hours and 14 days for overall and anterior infarcts) was appropriate in this study due to the absence of an externally validated benchmark which would normally serve as the basis for hypothesis testing of FDY-5301's effect on arrhythmias.|||
71782037|NCT03470441|143063535|SUPERIORITY||Median Difference (Final Values)|-3.2||||0.32|TWO_SIDED|95.15|-10.8|3.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||3.1|-10.8|0.32
71782038|NCT03470441|143063537|SUPERIORITY||Median Difference (Final Values)|-4.4||||0.46|TWO_SIDED|95.16|-20.2|12.1|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test Comparing placebo to anterior infarcts FDY-5301 treated subjects (low, intermediate, and high) combined into one group.||12.10|-20.2|0.46
71782039|NCT03470441|143063543|SUPERIORITY||Median Difference (Final Values)|3.7||||0.25|TWO_SIDED|95.11|-3.6|10.6|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||10.6|-3.6|0.25
71782040|NCT03470441|143063545|SUPERIORITY||Median Difference (Final Values)|4.9||||0.31|TWO_SIDED|95.16|-7.0|16.9|||Wilcoxon (Mann-Whitney)|||Wilcoxon Mann-Whitney Test comparing placebo to anterior infarcts FDY-5301 treated subjects (combined low dose, intermediate dose, and high dose).||16.9|-7|0.31
71782041|NCT03768414|143063549|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.72|1.14|||Log Rank|||||1.14|0.72|0.41
71782042|NCT00864383|143063557|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.|Adjusted difference in proportions|6.1|||||TWO_SIDED|97.5|1.7|10.5|||||Adjusted difference from control in proportion of unfavorable outcome - percentage points|||10.5|1.7|
71782043|NCT00864383|143063557|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the proportion of patients with an unfavorable outcome.|Adjusted difference from control|11.4|||||TWO_SIDED|97.5|6.7|16.1|||||Adjusted difference from control in rate of unfavorable outcome- percentage points|||16.1|6.7|
71782044|NCT00824720|143063627|SUPERIORITY_OR_OTHER||least square mean difference|-0.22|STANDARD_DEVIATION|2.3||0.9737|||||||ANCOVA||Mean difference was calculated as high dose minus placebo.|The alternative hypothesis was that the high dose was different from the placebo.||||0.9737
71782045|NCT00824720|143063627|SUPERIORITY_OR_OTHER||least square mean difference|-1.11|STANDARD_DEVIATION|3.5||0.4711|||||||ANCOVA||The mean difference was calculated as low dose minus placebo.|The alternative hypothesis is that the low dose was different from placebo.||||0.4711
71782046|NCT02513394|143063677|OTHER||Hazard Ratio (HR)|0.96||||0.65|TWO_SIDED|95.0|0.81|1.14|||Log Rank||This two sided p value was stratified by (neo)adjuvant chemotherapy (yes vs no) and age (\<=50 vs \>50).|||1.14|0.81|0.65
71782047|NCT02513394|143063678|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.82|1.19||||||||1.19|0.82|
71835415|NCT04337372|143175823|SUPERIORITY||||||=|0.002||||||F(2, 58) = 7.19|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of age is reported here.||||=.002
71782048|NCT02513394|143063679|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.87|1.28||||||||1.28|0.87|
71782049|NCT02513394|143063680|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.98|1.78||||||||1.78|0.98|
71782050|NCT02513394|143063681|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.57|1.23||||||||1.23|0.57|
71782051|NCT03187197|143063695|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 2.||||0.0001
71782052|NCT03187197|143063695|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 3.||||0.0001
71782053|NCT03187197|143063695|OTHER|||||||0.0031|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 2.||||0.0031
71782054|NCT03187197|143063695|OTHER|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 3.||||0.0001
71782055|NCT03187197|143063696|OTHER|||||||0.7879|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment convenience before PSM.||||0.7879
71668358|NCT04660331|142853288|OTHER||||||||||||||||||2-sided t-test conducted for pre- and post-training results.|||
71782056|NCT03187197|143063696|OTHER|||||||0.611|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment convenience before PSM.||||0.6110
71782057|NCT03187197|143063696|OTHER|||||||0.0832|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment satisfaction before PSM.||||0.0832
71782058|NCT03187197|143063696|OTHER|||||||0.6488|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment satisfaction before PSM.||||0.6488
71782059|NCT03187197|143063696|OTHER|||||||0.1301|||||||Two sample T test|||Between group comparison of Visit 2 treatment convenience after PSM.||||0.1301
71782060|NCT03187197|143063696|OTHER|||||||0.1257|||||||Two sample T test|||Between group comparison of Visit 2 treatment satisfaction after PSM.||||0.1257
71782061|NCT02200211|143063700|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.||0.53||
71782062|NCT02200211|143063700|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).||0.53||
71782063|NCT02200211|143063700|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||ONE_SIDED|95.0||0.54|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).||0.54||
71782064|NCT02200211|143063700|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.56|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to \<20 weeks after randomization).||0.56||
71782065|NCT02200211|143063700|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||ONE_SIDED|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).||0.53||
71835416|NCT04337372|143175823|SUPERIORITY||||||=|0.09||||||F(1.78, 103.37) = 2.48|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The main effect of condition is reported here.||||=.09
71835417|NCT04337372|143175823|SUPERIORITY||||||<|0.05||||||F(3.56, 103.37) = 2.55|MANOVA|||To examine the impact of infant age and label condition on the proportion of infant's attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and infant's proportion of attention to the book was the dependent variable. The interaction between age and condition is reported here.||||<.05
71668359|NCT04660331|142853289|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
71782066|NCT02200211|143063700|NON_INFERIORITY|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||ONE_SIDED|95.0||0.55|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).||0.55||
71782067|NCT02200211|143063700|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.04|0.58|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.|Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.||0.58|0.04|
71782068|NCT02200211|143063702|SUPERIORITY||Mean Difference (Final Values)|-2.7||||0.082|TWO_SIDED|95.0|-5.7|0.3||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANCOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to \<20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.||0.3|-5.7|0.082
71782069|NCT02200211|143063702|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-5.9|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).||0.5|-5.9|
71782070|NCT02200211|143063702|SUPERIORITY||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-5.9|0.3|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).||0.3|-5.9|
71782071|NCT02200211|143063702|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-5.0|1.2|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).||1.2|-5.0|
71782072|NCT02200211|143063702|SUPERIORITY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.5|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).||0.5|-5.5|
71782073|NCT02200211|143063702|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.7|0.4|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to \<20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.||0.4|-5.7|
71782074|NCT02200211|143063706|SUPERIORITY||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-4.0|13.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (treated as a continuous covariate).||13|-4|
71835418|NCT04337372|143175824|SUPERIORITY||||||=|0.557||||||F(2,47) = .592|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of age is reported here.||||=.557
71668360|NCT04660331|142853290|OTHER||||||||||||||||||We grouped pharmacy data on vaccines delivered pre/post intervention into six categories: HPV vaccine, Tdap, Meningococcal, Influenza, COVID-19, and other vaccines. We then compared the counts of total vaccines that were conducted in each group pre- and post-training.|||
71668361|NCT02635984|142853291|SUPERIORITY|||||||0.003|||||||Chi-squared|||Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.||||0.003
71668362|NCT02635984|142853292|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71668363|NCT02635984|142853293|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71668364|NCT02635984|142853294|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
71668365|NCT02635984|142853295|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71668366|NCT02635984|142853296|SUPERIORITY|||||||0.006|||||||Chi-squared|||||||0.006
71668367|NCT02635984|142853297|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71782075|NCT02200211|143063706|SUPERIORITY||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-31.0|2.0|||||Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.||2|-31|
71782076|NCT02200211|143063707|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.0|5.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to \<7, 7 to \<13 years) and baseline visual acuity (20/40, 20/50 or worse).||5|-1|
71782077|NCT02200211|143063708|SUPERIORITY|||||||0.83||||||For testing the interaction term, the a priori threshold for statistical significance was 0.05.|ANCOVA|Previously described above in the Statistical Analysis Overview section.||A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p\>0.05), no further comparisons would be performed.||||0.83
71668368|NCT02635984|142853298|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71668369|NCT01776632|142853304|SUPERIORITY||difference of adjusted means|0.15||||0.03|TWO_SIDED||||||generalized linear mixed effects|||||||.03
71668370|NCT01776632|142853305|SUPERIORITY||difference of adjusted means|0.39||||0.003|TWO_SIDED||||||generalized linear mixed effects|||||||.003
71668371|NCT01776632|142853306|SUPERIORITY||difference of adjusted means|-0.43||||0.04|TWO_SIDED||||||mixed effects models|||||||.04
71782078|NCT02200211|143063709|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.|ANCOVA|Previously described in the Statistical Analysis Overview.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.83
71668372|NCT01776632|142853307|SUPERIORITY||difference of adjusted means|-1.27||||0.09|TWO_SIDED||||||mixed effects models|||||||.09
71668373|NCT00708110|142853312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|||<|0.001|TWO_SIDED|95.0|-2.0|-1.07|||ANCOVA|||||-1.07|-2.00|<0.001
71668374|NCT00708110|142853312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||<|0.001|TWO_SIDED|95.0|-2.52|-1.55|||ANCOVA|||||-1.55|-2.52|<0.001
71668375|NCT00708110|142853312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-2.94|-2.02|||ANCOVA|||||-2.02|-2.94|<0.001
71668376|NCT00951496|142853340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.94||||0.341|TWO_SIDED|95.0|0.81|1.09||P value not adjusted for multiplicity. Significance Threshold = 0.027|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.|P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I||1.09|0.81|0.341
71668377|NCT00951496|142853340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.99||||0.587|TWO_SIDED|95.0|0.86|1.15||P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.|P value from a log rank test comparing the progression free survival hazards of arm III to arm I.||1.15|0.86|0.587
71668378|NCT01526057|142853347|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|105.67|||||TWO_SIDED|90.0|96.91|115.21|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.21|96.91|
71891607|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.438|-0.094|0.2045
71891608|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.885|0.351|<0.0001
71891609|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.223|-0.313|0.7432
71750024|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8547|TWO_SIDED|95.0|0.24|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.24|0.8547
71750025|NCT03192176|143005310|SUPERIORITY||Odds Ratio (OR)|0.66||||0.5023|TWO_SIDED|95.0|0.2|2.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.19|0.20|0.5023
71750026|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0093|TWO_SIDED|95.0|1.41|11.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.35|1.41|0.0093
71750027|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0035|TWO_SIDED|95.0|1.66|13.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.09|1.66|0.0035
71750028|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|8.48|||<|0.0001|TWO_SIDED|95.0|3.01|23.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.90|3.01|<0.0001
71750029|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|7.57||||0.0002|TWO_SIDED|95.0|2.65|21.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.59|2.65|0.0002
71891610|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.245|-0.290|0.8687
71750030|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.13||||0.1664|TWO_SIDED|95.0|0.73|6.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.22|0.73|0.1664
71750031|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0012|TWO_SIDED|95.0|1.94|14.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.96|1.94|0.0012
71750032|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|9.85|||<|0.0001|TWO_SIDED|95.0|3.49|27.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||27.86|3.49|<0.0001
71750033|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0334|TWO_SIDED|95.0|1.08|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.89|1.08|0.0334
71750034|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0034|TWO_SIDED|95.0|1.6|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.62|1.60|0.0034
71813100|NCT03720938|143128558|SUPERIORITY|||||||3.06e-06||||||"Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.~Adjusted for cluster effect, and small sample sizes, baseline value and age."|Linear mixed effects model|Satterthwaite's correction method for denominator degrees of freedom.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000306
71782079|NCT02200211|143063709|SUPERIORITY|||||||0.54||||||The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.|ANCOVA|Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.54
71782080|NCT02200211|143063709|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.||||0.80
71782081|NCT02200211|143063709|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.||||0.99
71782082|NCT02200211|143063709|SUPERIORITY|||||||0.87||||||The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.87
71782083|NCT02200211|143063709|SUPERIORITY|||||||0.33||||||The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.33
71782084|NCT02200211|143063709|SUPERIORITY|||||||0.23||||||The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.||||0.23
71782085|NCT02200211|143063714|SUPERIORITY|||||||0.66||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.66
71782086|NCT02200211|143063714|SUPERIORITY|||||||0.83||||||A priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.83
71782087|NCT02200211|143063715|SUPERIORITY|||||||0.19||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.19
71782088|NCT02200211|143063715|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.||||0.69
71782089|NCT02200211|143063721|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.02|0.3|||||A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.|The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.||0.30|0.02|
71668379|NCT01526057|142853347|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|106.62|||||TWO_SIDED|90.0|97.65|116.41|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||116.41|97.65|
71782090|NCT02200211|143063722|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-1.1|1.3|||||A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.||1.3|-1.1|
71782091|NCT02200211|143063723|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.32
71782092|NCT02200211|143063723|SUPERIORITY|||||||0.68|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.||||0.68
71782093|NCT02200211|143063724|SUPERIORITY|||||||0.17|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||0.17
71782094|NCT02200211|143063724|SUPERIORITY|||||||0.48|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.48
71782095|NCT02200211|143063724|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
71782096|NCT02200211|143063724|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
71782097|NCT02200211|143063725|SUPERIORITY|||||||0.05|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||0.05
71782098|NCT02200211|143063725|SUPERIORITY|||||||0.02|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.02
71782099|NCT02200211|143063725|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.||||>0.99
71782100|NCT02200211|143063725|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
71782101|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.62||||0.055|TWO_SIDED|90.0|0.44|0.88||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.44|0.055
71782102|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.64|||<|0.001|TWO_SIDED|90.0|0.55|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.55|<0.001
71782103|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.68||||0.22|TWO_SIDED|90.0|0.44|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.44|0.22
71782104|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.6|||<|0.001|TWO_SIDED|90.0|0.49|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.49|<0.001
71782105|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.76|||<|0.05|TWO_SIDED|90.0|0.64|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.64|<0.05
71782106|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.71|||<|0.05|TWO_SIDED|90.0|0.57|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.57|<0.05
71782107|NCT00042289|143063728|SUPERIORITY||Geometric mean ratio|0.98||||0.78|TWO_SIDED|90.0|0.71|1.35||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.35|0.71|0.78
71782108|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.42|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.42|<0.05
71782109|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.63|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.63|<0.05
71782110|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|0.58||||0.03|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.03
71782111|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|0.67||||0.001|TWO_SIDED|90.0|0.51|0.89||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.51|0.001
71782112|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|1.34||||0.0684|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.0684
71782113|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|0.58|||<|0.05|TWO_SIDED|90.0|0.49|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.49|<0.05
71782114|NCT00042289|143063729|SUPERIORITY||Geometric mean ratio|0.6|||<|0.05|TWO_SIDED|90.0|0.53|0.68||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.53|<0.05
71782115|NCT00042289|143063730|SUPERIORITY||Geometric mean ratio|0.72||||0.008|TWO_SIDED|90.0|0.6|0.88||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||0.88|0.60|0.008
71782116|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.63||||0.002|TWO_SIDED|90.0|0.52|0.75||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.75|0.52|0.002
71782117|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.71||||0.0003|TWO_SIDED|90.0|0.63|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.63|0.0003
71782118|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.57||||0.09|TWO_SIDED|90.0|0.34|0.98||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.98|0.34|0.09
71782119|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.67||||0.004|TWO_SIDED|90.0|0.54|0.82||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.82|0.54|0.004
71782120|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.79||||0.27|TWO_SIDED|90.0|0.5|1.27||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.27|0.50|0.27
71782121|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.86||||0.7|TWO_SIDED|90.0|0.66|1.12||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.66|0.70
71782122|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.62||||0.46|TWO_SIDED|90.0|0.29|1.34||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.34|0.29|0.46
71782123|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.94||||0.5|TWO_SIDED|90.0|0.63|1.39||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.39|0.63|0.50
71782124|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.76|||<|0.1|TWO_SIDED|90.0|0.57|1.0||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.0|0.57|<0.10
71782125|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.56|||<|0.1|TWO_SIDED|90.0|0.42|0.73||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.73|0.42|<0.10
71782126|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.47|||<|0.1|TWO_SIDED|90.0|0.33|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.33|<0.10
71782127|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.44|||<|0.1|TWO_SIDED|90.0|0.36|0.54||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.54|0.36|<0.10
71782128|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.74||||0.1875|TWO_SIDED|90.0|0.53|1.04||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.04|0.53|0.1875
71668380|NCT01526057|142853347|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.9|||||TWO_SIDED|90.0|92.38|110.2|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||110.20|92.38|
71668381|NCT01526057|142853348|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|104.19|||||TWO_SIDED|90.0|92.75|117.06||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||117.06|92.75|
71782129|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.46||||0.1563|TWO_SIDED|90.0|0.19|1.11||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.11|0.19|0.1563
71782130|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.94||||0.241|TWO_SIDED|90.0|0.85|1.03||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.85|0.241
71782131|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|1.09||||0.837|TWO_SIDED|90.0|0.9|1.32||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.32|0.90|0.837
71782132|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.88||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.88|0.55|<0.05
71782133|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.8||||0.0046|TWO_SIDED|90.0|0.72|0.89||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.89|0.72|0.0046
71782134|NCT00042289|143063731|SUPERIORITY||Geometric mean ratio|0.66|||<|0.05|TWO_SIDED|90.0|0.52|0.85||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.85|0.52|<0.05
71782135|NCT00042289|143063731|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782136|NCT00042289|143063731|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71835419|NCT04337372|143175824|SUPERIORITY||||||=|0.47||||||F(2,47) = .767|MANOVA|||EEG power, as measured by the signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each of the conditions. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The main effect of condition is reported here.||||=.470
71668382|NCT01526057|142853348|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.45|||||TWO_SIDED|90.0|89.2|113.11||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.11|89.20|
71782137|NCT00042289|143063731|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
71782138|NCT00042289|143063731|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
71782139|NCT00042289|143063731|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782140|NCT00042289|143063731|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782141|NCT00042289|143063732|SUPERIORITY||Geometric mean ratio|0.97||||0.07|TWO_SIDED|90.0|0.83|1.13||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.13|0.83|0.07
71782142|NCT00042289|143063732|SUPERIORITY||Geometric mean ratio|0.77|||<|0.05|TWO_SIDED|90.0|0.61|0.96||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.96|0.61|<0.05
71782143|NCT00042289|143063732|SUPERIORITY||Geometric mean ratio|0.8|||<|0.05|TWO_SIDED|90.0|0.62|1.03||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.03|0.62|<0.05
71782144|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.81||||0.148|TWO_SIDED|90.0|0.64|1.01||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.01|0.64|0.148
71782145|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.71|||<|0.001|TWO_SIDED|90.0|0.62|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.81|0.62|<0.001
71782146|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.74||||0.0098|TWO_SIDED|90.0|0.61|0.89||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.89|0.61|0.0098
71782147|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.75||||0.0025|TWO_SIDED|90.0|0.64|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.88|0.64|0.0025
71782148|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.54|||<|0.0001|TWO_SIDED|90.0|0.46|0.64||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.64|0.46|<0.0001
71782149|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.56||||0.0024|TWO_SIDED|90.0|0.41|0.76||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.76|0.41|0.0024
71782150|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.795||||0.438|TWO_SIDED|90.0|0.499|1.269||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.269|0.499|0.438
71782151|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.531||||0.219|TWO_SIDED|90.0|0.186|1.512||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.512|0.186|0.219
71782152|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|1.05||||0.296|TWO_SIDED|90.0|0.94|1.18||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.18|0.94|0.296
71782153|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|1.26||||0.007|TWO_SIDED|90.0|1.01|1.56||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.56|1.01|0.007
71668383|NCT01526057|142853348|EQUIVALENCE|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|96.4|||||TWO_SIDED|90.0|85.57|108.6||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||108.60|85.57|
71782154|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.83||||0.16|TWO_SIDED|90.0|0.56|1.22||2nd Trimester vs Postpartum|Wilcoxon signed rank test|||FPV was analyzed as the form of amprenavir (APV). FPV is the prodrug of APV.||1.22|0.56|0.16
71782155|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.74||||0.03|TWO_SIDED|90.0|0.58|0.93|||Wilcoxson signed rank test|||FPV was analyzed in the form of amprenavir (APV). FPV is the prodrug of APV.||0.93|0.58|0.03
71782156|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.86|||>|0.05|TWO_SIDED|90.0|0.68|1.08||3rd Trimester vs. Postpartum (No comparison was done for 2nd Trimester vs. Postpartum since the sample size for 2nd trimester was 1)|Wilcoxon signed rank test|||This analysis was for ATV.||1.08|0.68|>0.05
71782157|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.89||||0.1636|TWO_SIDED|90.0|0.79|1.01||Third Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||||1.01|0.79|0.1636
71782158|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.69|||<|0.05|TWO_SIDED|90.0|0.53|0.91||3rd Trimester vs Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 4 participants had Second Trimester data)|Wilcoxon signed rank test|||This analysis was for ATV.||0.91|0.53|<0.05
71668384|NCT01526057|142853349|SUPERIORITY||Test-to-reference ratio: adjusted means|103.74|||||TWO_SIDED|90.0|95.1|113.12|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.12|95.10|
71668385|NCT01526057|142853349|SUPERIORITY||Test-to-reference ratio: adjusted means|105.56|||||TWO_SIDED|90.0|96.64|115.3|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.30|96.64|
71668386|NCT01526057|142853349|SUPERIORITY||Test-to-reference ratio: adjusted means|101.76|||||TWO_SIDED|90.0|93.13|111.18|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.||111.18|93.13|
71668387|NCT01526057|142853350|SUPERIORITY||Test-to-reference ratio: adjusted means|103.36|||||TWO_SIDED|90.0|92.81|115.12||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||115.12|92.81|
71782159|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|1.11||||0.16|TWO_SIDED|90.0|0.99|1.24||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since there was no Second Trimester data available)|Wilcoxon signed rank test|||||1.24|0.99|0.16
71782160|NCT00042289|143063733|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71668388|NCT01526057|142853350|SUPERIORITY||Test-to-reference ratio: adjusted means|101.33|||||TWO_SIDED|90.0|90.82|113.04||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||113.04|90.82|
71668389|NCT01526057|142853350|SUPERIORITY||Test-to-reference ratio: adjusted means|98.03|||||TWO_SIDED|90.0|87.83|109.4||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.||109.40|87.83|
71782161|NCT00042289|143063733|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782162|NCT00042289|143063733|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782163|NCT00042289|143063733|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782164|NCT00042289|143063733|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
71782165|NCT00042289|143063733|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
71782166|NCT00042289|143063733|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782167|NCT00042289|143063733|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782168|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|1.06||||0.67|TWO_SIDED|90.0|0.85|1.34||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 2 participants had Second Trimester data)|Wilcoxon signed-rank test|||||1.34|0.85|0.67
71782169|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.73||||0.08|TWO_SIDED|90.0|0.59|0.91||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.91|0.59|0.08
71782170|NCT00042289|143063733|SUPERIORITY||Geometric mean of ratio|0.63|||<|0.01|TWO_SIDED|90.0|0.55|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.72|0.55|<0.01
71782171|NCT00042289|143063734|SUPERIORITY||Geometric mean of ratio|0.57|||<|0.05|TWO_SIDED|90.0|0.48|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.68|0.48|<0.05
71782172|NCT00042289|143063734|SUPERIORITY||Geometric mean of ratio|0.73|||<|0.05|TWO_SIDED|90.0|0.62|0.85||3rd Trimester vs.Postpartum|Wilcoxon signed rank test|||||0.85|0.62|<0.05
71782173|NCT00042289|143063734|SUPERIORITY|||||||0.09||||||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.09
71835420|NCT04337372|143175824|SUPERIORITY||||||=|0.046||||||F(4,94) = 2.524|MANOVA|||EEG power, as measured by signal-to-noise ratio (SNR) was modulated by label condition across age, data were extracted from a mid-occipital cluster of Oz and its 6 nearest neighbors (channels 70, 71, 74, 75, 76, 82, 83) for each condition. SNR data were then submitted to a two-factor MANOVA with Label (Individual, Category, Control/No Label) as a within-subjects factor and Age (6 months, 9 months, 12 months) as a between-subjects factor. The interaction of age and condition is reported here.||||=.046
71835421|NCT04337372|143175825|SUPERIORITY||||||=|0.664||||||F(2,45) = .413|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of age is reported here.||||=.664
71835422|NCT04337372|143175825|SUPERIORITY||||||=|0.768||||||F(2,45) = .266|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The main effect of condition is reported here.||||=.768
71835423|NCT04337372|143175825|SUPERIORITY||||||=|0.2||||||F(4,90) = 1.531|MANOVA|||EEG Data were extracted from a mid-occipital cluster for each conditions for parents \& infants. Data were entered into a 2-factor MANOVA with Label (Individual, Category, No Label) as a within-subjects factor and Age (6 mo, 9 mo, 12 mo) as a between-subjects factor. The phase-locking index measures the extent to which the parent \& infant oscillatory response is in the same phase across time (bounded between 0 and 1, 1 being perfect synchrony. The interaction of age and condition is reported.||||=.200
71835424|NCT04337372|143175826|SUPERIORITY||||||=|0.022||||||F(2, 57) = 4.11|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of age is reported here.||||=.022
71835425|NCT04337372|143175826|SUPERIORITY||||||=|0.004||||||F(2, 114) = 5.69|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The main effect of condition is reported here.||||=.004
71668390|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.31|1.78|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.78|0.31|
71835426|NCT04337372|143175826|SUPERIORITY||||||=|0.168||||||F(4, 114) = 1.64|MANOVA|||To examine the impact of infant age and label condition on the proportion of joint attention to the book, a 3 (infant age: 6, 9, or 12 months) x 3 (label condition: individual, categorical, or no label) MANOVA was run. Age was measured between subjects, label condition was within subjects, and the proportion of joint attention to the book was the dependent variable. The interaction of age and condition is reported here.||||=.168
71835427|NCT03611153|143175829|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.040
71835428|NCT03611153|143175831|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
71835429|NCT03611153|143175832|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||Right atrial pressure||||0.805
71835430|NCT03611153|143175832|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||pulmonary artery systolic pressure||||0.148
71835431|NCT03611153|143175832|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.090
71835432|NCT03611153|143175833|SUPERIORITY|||||||0.786|||||||t-test, 2 sided|||Right atrial pressure||||0.786
71835433|NCT03611153|143175833|SUPERIORITY|||||||0.796|||||||t-test, 2 sided|||Pulmonary artery systolic pressure||||0.796
71835434|NCT03611153|143175833|SUPERIORITY|||||||0.703|||||||t-test, 2 sided|||Mean pulmonary artery pressure||||0.703
71835435|NCT03611153|143175834|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
71835436|NCT03611153|143175835|SUPERIORITY|||||||0.669|||||||t-test, 2 sided|||||||0.669
71835437|NCT04840199|143175846|SUPERIORITY||Mean Difference (Net)|-0.031||||0.2|TWO_SIDED|95.0|-0.08|0.018||No adjustment for multiple comparisons|Regression, Linear||Treatment effect was estimated as the difference in mean change in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a linear regression model (0 reflects no difference between arms).|||0.018|-0.080|0.20
71835438|NCT04840199|143175847|SUPERIORITY||Risk Difference (RD)|0.172||||0.19|TWO_SIDED|95.0|-0.073|0.438||No adjustment for multiple comparisons|Chan/Zhang exact test diff. proportions||An exact 95% confidence interval around the observed difference in proportions (and the associated p-value) was constructed based on the standardized statistic and inverting two 1-sided tests (Chan-Zhang method).|||0.438|-0.073|0.19
71668391|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.6|1.88|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.88|0.60|
71782174|NCT00042289|143063734|SUPERIORITY|||||||0.003||||||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||||0.003
71782175|NCT00042289|143063734|SUPERIORITY||Geometric mean of ratio|1.34||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since only 5 participants had Second Trimester data)|Wilcoxon signed rank test|||||||0.036
71782176|NCT00042289|143063734|SUPERIORITY||Geometric mean of ratio|0.84|||>|0.05|TWO_SIDED|90.0|0.69|1.02||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.02|0.69|>0.05
71782177|NCT00042289|143063734|SUPERIORITY||Geometric mean of ratio|0.83|||>|0.05|TWO_SIDED|90.0|0.68|1.01||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.01|0.68|>0.05
71835439|NCT04840199|143175849|SUPERIORITY||Odds Ratio (OR)|0.91||||0.12|TWO_SIDED|95.0|0.8|1.03||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||1.03|0.80|0.12
71835440|NCT04840199|143175849|SUPERIORITY||Odds Ratio (OR)|0.92||||0.009|TWO_SIDED|95.0|0.87|0.98||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.98|0.87|0.009
71835441|NCT04840199|143175849|SUPERIORITY||Odds Ratio (OR)|1.17||||0.24|TWO_SIDED|95.0|0.9|1.53||No adjustment for multiple comparisons|GEE model for repeated binary outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the odds ratio of weekly rate of change (slope) in odds of CMV DNA detection with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||1.53|0.90|0.24
71891611|NCT01431287|143304575|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.246|-0.290|0.8709
71668392|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.66|1.73|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.73|0.66|
71782178|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.61||||0.14|TWO_SIDED|90.0|0.34|1.09||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.09|0.34|0.14
71782179|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.64||||0.002|TWO_SIDED|90.0|0.5|0.81||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.81|0.50|0.002
71782180|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.77||||0.24|TWO_SIDED|90.0|0.49|1.23||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.23|0.49|0.24
71835442|NCT04840199|143175852|SUPERIORITY||Mean Difference (Net)|0.0002||||0.95|TWO_SIDED|95.0|-0.0062|0.0066||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Early treatment phase comparison||0.0066|-0.0062|0.95
71835443|NCT04840199|143175852|SUPERIORITY||Mean Difference (Net)|-0.0007||||0.28|TWO_SIDED|95.0|-0.0019|0.0005||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Late treatment phase comparison||0.0005|-0.0019|0.28
71668393|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.73|1.56|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.56|0.73|
71668394|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.68|1.62|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.62|0.68|
71668395|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.66|1.69|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.69|0.66|
71782181|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.84||||0.53|TWO_SIDED|90.0|0.6|1.17||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.17|0.60|0.53
71782182|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.58||||0.2|TWO_SIDED|90.0|0.3|1.11||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.11|0.30|0.2
71782183|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.95||||0.12|TWO_SIDED|90.0|0.58|1.55||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.55|0.58|0.12
71782184|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.92||||0.358|TWO_SIDED|90.0|0.71|1.2||2nd Trimester vs. Postpartum|Wilcoxon signed rank test|||||1.2|0.71|0.358
71782185|NCT00042289|143063735|SUPERIORITY||Geometric mean of ratio|0.72||||0.0156|TWO_SIDED|90.0|0.55|0.93||3rd Trimester vs. Postpartum|Wilcoxon signed rank test|||||0.93|0.55|0.0156
71782186|NCT00042289|143063736|SUPERIORITY||Geometric mean of ratio|0.7||||0.007|TWO_SIDED|90.0|0.58|0.85||3rd Trimester vs. Postpartum (No comparison was done for Second Trimester vs. Postpartum since no Second Trimester data was available)|Wilcoxon signed rank test|||||0.85|0.58|0.007
71782187|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|0.66||||0.109|TWO_SIDED|90.0|0.39|1.12||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.12|0.39|0.109
71782188|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.49|0.69||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.69|0.49|<0.001
71782189|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|0.48||||0.44|TWO_SIDED|90.0|0.14|1.65||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.65|0.14|0.44
71782190|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|0.56|||<|0.001|TWO_SIDED|90.0|0.43|0.72||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.72|0.43|<0.001
71782191|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|0.83||||0.43|TWO_SIDED|90.0|0.63|1.1||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.10|0.63|0.43
71782192|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|1.0||||0.31|TWO_SIDED|90.0|0.69|1.44||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.44|0.69|0.31
71782193|NCT00042289|143063737|SUPERIORITY||Geometric mean ratio|0.9||||0.49|TWO_SIDED|90.0|0.71|1.16||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.16|0.71|0.49
71782194|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|0.45|||<|0.05|TWO_SIDED|90.0|0.32|0.63||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.63|0.32|<0.05
71782195|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|0.72|||<|0.05|TWO_SIDED|90.0|0.58|0.88||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.88|0.58|<0.05
71782196|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|0.42||||0.02|TWO_SIDED|90.0|0.23|0.78||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.78|0.23|0.02
71782197|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|0.78||||0.3|TWO_SIDED|90.0|0.56|1.08||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.08|0.56|0.3
71782198|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|1.41||||0.036|TWO_SIDED|||||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||||0.036
71782199|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|0.41|||<|0.05|TWO_SIDED|90.0|0.32|0.52||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.52|0.32|<0.05
71668396|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.7|2.0|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||2.00|0.70|
71782200|NCT00042289|143063738|SUPERIORITY||Geometric mean ratio|0.48|||<|0.05|TWO_SIDED|90.0|0.41|0.57||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.57|0.41|<0.05
71782201|NCT00042289|143063739|SUPERIORITY||Geometric mean ratio|0.85||||0.1|TWO_SIDED|90.0|0.72|1.01||3rd Trimester vs. Postpartum|t-test, 2 sided|Paired sample t-test on natural log-transformed PK parameter||||1.01|0.72|0.10
71782202|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.49||||0.0039|TWO_SIDED|90.0|0.35|0.68||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.68|0.35|0.0039
71782203|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.66||||0.0062|TWO_SIDED|90.0|0.52|0.84||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.84|0.52|0.0062
71782204|NCT00042289|143063740|SUPERIORITY||||||<|0.1||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
71782205|NCT00042289|143063740|SUPERIORITY||||||<|0.1||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.10
71782206|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.15|||<|0.1|TWO_SIDED|90.0|0.08|0.3||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.30|0.08|<0.10
71782207|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.21|||<|0.1|TWO_SIDED|90.0|0.12|0.36||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.36|0.12|<0.10
71782208|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.32|||<|0.1|TWO_SIDED|90.0|0.2|0.51||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.51|0.20|<0.10
71782209|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.32|||>|0.1|TWO_SIDED|90.0|0.11|0.94||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.94|0.11|>0.10
71782210|NCT00042289|143063740|OTHER||Geometric mean ratio|0.87||||0.079|TWO_SIDED|90.0|0.78|0.97||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.97|0.78|0.079
71782211|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.92||||0.01|TWO_SIDED|90.0|0.77|1.09||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.09|0.77|0.01
71782212|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.51|||<|0.05|TWO_SIDED|90.0|0.37|0.72||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.72|0.37|<0.05
71782213|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.82||||0.0325|TWO_SIDED|90.0|0.71|0.96||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.96|0.71|0.0325
71782214|NCT00042289|143063740|SUPERIORITY||Geometric mean ratio|0.65|||<|0.05|TWO_SIDED|90.0|0.54|0.77||3rd Trimester vs. Postpartum \[Note: Comparison of 2nd Trimester vs. Postpartum was not done due to low sample size.\]|Wilcoxon signed-rank test|||||0.77|0.54|<0.05
71782215|NCT00042289|143063740|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782216|NCT00042289|143063740|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782217|NCT00042289|143063740|SUPERIORITY||||||>|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
71782218|NCT00042289|143063740|SUPERIORITY||||||>|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||>0.05
71782219|NCT00042289|143063740|SUPERIORITY||||||<|0.05||||||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782220|NCT00042289|143063740|SUPERIORITY||||||<|0.05||||||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||||<0.05
71782221|NCT00042289|143063741|SUPERIORITY||Geometric mean ratio|0.88|||<|0.05|TWO_SIDED|90.0|0.73|1.06||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.06|0.73|<0.05
71750035|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|6.55||||0.0002|TWO_SIDED|95.0|2.45|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||17.47|2.45|0.0002
71782222|NCT00042289|143063741|SUPERIORITY||Geometric mean ratio|0.7|||<|0.05|TWO_SIDED|90.0|0.55|0.9||2nd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||0.90|0.55|<0.05
71782223|NCT00042289|143063741|SUPERIORITY||Geometric mean ratio|0.84|||<|0.05|TWO_SIDED|90.0|0.57|1.23||3rd Trimester vs. Postpartum|Wilcoxon signed-rank test|||||1.23|0.57|<0.05
71668397|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.28|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||1.73|0.28|
71668398|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.43|1.54|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.54|0.43|
71750036|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.9||||0.0014|TWO_SIDED|95.0|1.85|12.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.98|1.85|0.0014
71782224|NCT00042289|143063745|SUPERIORITY||Geometric mean of ratio|1.24||||0.114|TWO_SIDED|90.0|0.97|1.59||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical analysis is for LPV PK.||1.59|0.97|0.114
71782225|NCT00042289|143063746|SUPERIORITY||Geometric mean of ratio|1.1||||0.367|TWO_SIDED|90.0|0.84|1.44||Before ENG initiation vs. after ENG initiation|Wilcoxon signed rank test|||The statistical test is for ATV PK.||1.44|0.84|0.367
71782226|NCT00042289|143063746|SUPERIORITY||Geometric mean of ratio|1.02||||0.561|TWO_SIDED|90.0|0.92|1.13|||Wilcoxon signed rank test|Before ENG initiation vs. after ENG initiation||The statistical test is for EFV PK.||1.13|0.92|0.561
71668399|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.49|1.42|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.42|0.49|
71668400|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.22|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.22|0.50|
71750037|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0872|TWO_SIDED|95.0|0.89|5.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.74|0.89|0.0872
71750038|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0131|TWO_SIDED|95.0|1.28|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.98|1.28|0.0131
71750039|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0386|TWO_SIDED|95.0|1.05|6.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.43|1.05|0.0386
71750040|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0191|TWO_SIDED|95.0|1.2|8.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.05|1.20|0.0191
71750041|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0291|TWO_SIDED|95.0|1.11|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.26|1.11|0.0291
71750042|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|6.09||||0.0004|TWO_SIDED|95.0|2.23|16.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||16.58|2.23|0.0004
71750043|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|7.24||||0.0003|TWO_SIDED|95.0|2.49|21.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||21.02|2.49|0.0003
71750044|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.22||||0.0992|TWO_SIDED|95.0|0.86|5.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||5.72|0.86|0.0992
71782227|NCT00745823|143063771|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.7||||0.044|TWO_SIDED|95.0|-10.7|-0.83|||Miettinen and Nurminen|||||-0.83|-10.7|0.044
71668401|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.57|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.44|0.57|
71668402|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.88|2.1|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.10|0.88|
71750045|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0006|TWO_SIDED|95.0|2.11|15.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.16|2.11|0.0006
71750046|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.74||||0.006|TWO_SIDED|95.0|1.46|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.59|1.46|0.0060
71750047|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.01||||0.1472|TWO_SIDED|95.0|0.78|5.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.14|0.78|0.1472
71750048|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1284|TWO_SIDED|95.0|0.81|5.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.15|0.81|0.1284
71750049|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0117|TWO_SIDED|95.0|1.32|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||9.50|1.32|0.0117
71750050|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0067|TWO_SIDED|95.0|1.49|12.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||12.03|1.49|0.0067
71750051|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4088|TWO_SIDED|95.0|0.59|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||3.71|0.59|0.4088
71782228|NCT00745823|143063772|NON_INFERIORITY_OR_EQUIVALENCE|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.1||||0.011|TWO_SIDED|95.0|-9.29|-1.06|||Miettinen and Nurminen|||||-1.06|-9.29|0.011
71782229|NCT00745823|143063773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-5.0|4.6|||Miettinen and Nurminen|||||4.6|-5.0|
71782230|NCT00745823|143063774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-1.3|2.0||||||||2.0|-1.3|
71782231|NCT00745823|143063775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.56|||||TWO_SIDED|95.0|-7.29|34.4|||t-test, 2 sided|||||34.40|-7.29|
71782232|NCT01687998|143063781|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.006||||0.9054|TWO_SIDED|95.0|0.911|1.111|||Regression, Cox|||Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)||1.111|0.911|0.9054
71782233|NCT01687998|143063782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.11|||<|0.0001|TWO_SIDED|95.0|-38.15|-36.08|||ANOVA|||LDL-C||-36.08|-38.15|<0.0001
71782234|NCT01687998|143063782|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|131.55|||<|0.0001|TWO_SIDED|95.0|130.01|133.09|||ANOVA|||HDL-C||133.09|130.01|<0.0001
71782235|NCT01687998|143063783|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.991||||0.8463|TWO_SIDED|95.0|0.901|1.089|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA||1.089|0.901|0.8463
71782236|NCT01687998|143063784|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.001||||0.9874|TWO_SIDED|95.0|0.901|1.112|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization||1.112|0.901|0.9874
71782237|NCT01687998|143063785|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.003||||0.9574|TWO_SIDED|95.0|0.893|1.127|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA||1.127|0.893|0.9574
71782238|NCT01687998|143063786|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.965||||0.5917|TWO_SIDED|95.0|0.846|1.1|||Regression, Cox|||Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke||1.100|0.846|0.5917
71782239|NCT02955602|143063801|OTHER||||||=|0.2242|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 5 mg treatment groups after 8 weeks of treatment.||||= 0.2242
71668403|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.78|2.18|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||2.18|0.78|
71668404|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.36|2.45|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||2.45|0.36|
71668405|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||1.44|0.41|
71782240|NCT02955602|143063801|OTHER||||||=|0.0021|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 2 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0021
71782241|NCT02955602|143063801|OTHER||||||=|0.0024|||||||ANCOVA|||The analyses will assess the change from baseline in each treatment group and will assess the hypothesis that there are no differences in the percent change in ALP serum level between seladelpar 5 mg and 10 mg treatment groups after 8 weeks of treatment||||= 0.0024
71782242|NCT01258582|143063820|SUPERIORITY_OR_OTHER||difference in the acceptance rates|-0.022||||0.34|TWO_SIDED|95.0|-0.067|0.023|||Chi-squared|The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test.||Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).||0.023|-0.067|0.34
71782243|NCT01509950|143063912|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.60
71782244|NCT04115839|143063933|SUPERIORITY||Difference in response rates|26.9||||0.022|TWO_SIDED|95.0|4.3|49.6||The stratification factors (Geographic Region, Concurrent Use of conventional synthetic (cs) DMARD(s) and/or Apremilast at Randomization, Prior Use of biologic (bio)DMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||49.6|4.3|0.022
71782245|NCT04115839|143063933|SUPERIORITY||Difference in response rates|2.2||||0.89|TWO_SIDED|95.0|-20.5|25.0||The stratification factors (Geographic Region, Concurrent Use of csDMARD(s) and/or Apremilast at Randomization, Prior Use of bioDMARD(s)) and treatment groups were included in the imputation model as covariates.|Multiple imputation method|||||25.0|-20.5|0.89
71782246|NCT04115839|143063936|SUPERIORITY||Difference in response rates|-5.9||||0.39|TWO_SIDED|95.0|-21.6|9.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||9.9|-21.6|0.39
71782247|NCT04115839|143063936|SUPERIORITY||Difference in response rates|-2.6||||0.65|TWO_SIDED|95.0|-19.7|14.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||14.5|-19.7|0.65
71782248|NCT04115839|143063936|SUPERIORITY||Difference in response rates|0.9||||0.86|TWO_SIDED|-19.4|-19.4|21.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||21.3|-19.4|0.86
71668406|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.47|1.31|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.31|0.47|
71668407|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.48|1.13|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.13|0.48|
71782249|NCT04115839|143063936|SUPERIORITY||Difference in response rates|-2.9||||0.7|TWO_SIDED|95.0|-22.0|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.1|-22.0|0.70
71782250|NCT04115839|143063936|SUPERIORITY||Difference in response rates|12.4||||0.15|TWO_SIDED|95.0|-7.5|32.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||32.3|-7.5|0.15
71668408|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.55|1.36|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.36|0.55|
71668409|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.85|1.95|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||1.95|0.85|
71668410|NCT01526057|142853369|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.73|0.70|
71668411|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.12|1.79|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.||1.79|0.12|
71750052|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.09||||0.0194|TWO_SIDED|95.0|1.2|7.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.96|1.20|0.0194
71750053|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0423|TWO_SIDED|95.0|1.03|6.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.73|1.03|0.0423
71750054|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.86||||0.2151|TWO_SIDED|95.0|0.7|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.99|0.70|0.2151
71750055|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0531|TWO_SIDED|95.0|0.99|7.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.42|0.99|0.0531
71750056|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0118|TWO_SIDED|95.0|1.37|12.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||12.34|1.37|0.0118
71750057|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|16.28||||0.0006|TWO_SIDED|95.0|3.29|80.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||80.46|3.29|0.0006
71750058|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3698|TWO_SIDED|95.0|0.59|4.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.22|0.59|0.3698
71750059|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0059|TWO_SIDED|95.0|1.55|13.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.53|1.55|0.0059
71750060|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0241|TWO_SIDED|95.0|1.17|9.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.44|1.17|0.0241
71668412|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.2|1.26|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.||1.26|0.20|
71668413|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.43|1.41|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.||1.41|0.43|
71782251|NCT04115839|143063936|SUPERIORITY||Difference in response rates|8.8||||0.3|TWO_SIDED|95.0|-10.1|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||27.7|-10.1|0.30
71782252|NCT04115839|143063936|SUPERIORITY||Difference in response rates|22.3||||0.035|TWO_SIDED|95.0|-0.7|45.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.2|-0.7|0.035
71782253|NCT04115839|143063936|SUPERIORITY||Difference in response rates|12.1||||0.22|TWO_SIDED|95.0|-9.3|33.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic Region, concurrent Use of csDMARD(s) and/or Apremilast at Randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% confidence interval (CI) for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.5|-9.3|0.22
71782254|NCT04115839|143063938|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.8|2.8|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.8|-2.8|
71835444|NCT04840199|143175852|SUPERIORITY||Mean Difference (Net)|0.0056||||0.077|TWO_SIDED|95.0|-0.0006|0.0118||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sCD163 with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between treatment groups).|Post treatment phase comparison||0.0118|-0.0006|0.077
71835445|NCT04840199|143175853|SUPERIORITY||Mean Difference (Net)|0.0009||||0.72|TWO_SIDED|95.0|-0.004|0.0058||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the early treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Early treatment phase comparison||0.0058|-0.0040|0.72
71835446|NCT04840199|143175853|SUPERIORITY||Mean Difference (Net)|-0.0009||||0.13|TWO_SIDED|95.0|-0.0022|0.0003||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the late treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Late treatment phase comparison||0.0003|-0.0022|0.13
71835447|NCT04840199|143175853|SUPERIORITY||Mean Difference (Net)|0.0023||||0.17|TWO_SIDED|95.0|-0.001|0.0055||No adjustment for multiple comparisons|GEE model for repeated outcomes|P-value is from the time and treatment group interaction in the post treatment phase.|Treatment effect was estimated as the difference in weekly rate of change (slope) in log10 sTNFRII with randomized letermovir compared to no anti-CMV treatment from a GEE model with linear splines (1 reflects no difference between arms).|Post treatment phase comparison||0.0055|-0.0010|0.17
71835448|NCT04761302|143175854|SUPERIORITY|||||||0.215||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.215
71835449|NCT04761302|143175854|SUPERIORITY|||||||0.445||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.445
71835450|NCT04761302|143175855|SUPERIORITY|||||||0.041||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.041
71835451|NCT04761302|143175855|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.300
71835452|NCT04761302|143175856|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.12
71835453|NCT04761302|143175856|SUPERIORITY|||||||0.359||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.359
71835454|NCT04761302|143175857|SUPERIORITY|||||||0.083||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.083
71668414|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.61|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.||1.74|0.61|
71668415|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.56|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.||1.74|0.56|
71668416|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.34|1.36|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.||1.36|0.34|
71835455|NCT04761302|143175857|SUPERIORITY|||||||0.152||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.152
71835456|NCT04761302|143175858|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
71835457|NCT04761302|143175858|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
71668417|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.46|1.63|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).||1.63|0.46|
71668418|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.27|2.6|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.||2.60|0.27|
71835458|NCT04761302|143175859|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.002
71835459|NCT04761302|143175859|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
71835460|NCT04761302|143175860|SUPERIORITY|||||||0.004||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.004
71835461|NCT04761302|143175860|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
71835462|NCT04761302|143175861|SUPERIORITY|||||||0.006||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.006
71835463|NCT04761302|143175861|SUPERIORITY||||||<|0.001||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||<0.001
71835464|NCT04761302|143175862|SUPERIORITY|||||||0.354||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.354
71835465|NCT04761302|143175862|SUPERIORITY|||||||0.455||||||A priori threshold for statistical significance: \<0.05|t-test, 2 sided|||||||0.455
71835466|NCT05145257|143175864|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835467|NCT05145257|143175865|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71891612|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.898|0.362|<0.0001
71891613|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.703|0.166|0.0015
71891614|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.687|0.151|0.0022
71835468|NCT05145257|143175866|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835469|NCT05145257|143175867|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835470|NCT05145257|143175868|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835471|NCT05145257|143175869|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835472|NCT05145257|143175870|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835473|NCT05145257|143175871|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835474|NCT05145257|143175872|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835475|NCT05145257|143175873|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835476|NCT05145257|143175874|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835477|NCT05145257|143175875|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835478|NCT05145257|143175876|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835479|NCT05145257|143175877|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835480|NCT05145257|143175878|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835481|NCT05145257|143175879|OTHER||||||<|0.001||||||Baseline versus endline comparison.|ANOVA|||||||<0.001
71835482|NCT06023082|143175880|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835483|NCT06023082|143175881|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71835484|NCT06023082|143175882|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835485|NCT06023082|143175883|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835486|NCT06023082|143175884|OTHER|||||||0.4907||||||Baseline to Week 12 comparison.|ANOVA|||||||0.4907
71835487|NCT06023082|143175885|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835488|NCT06023082|143175886|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835489|NCT06023082|143175887|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835490|NCT06023082|143175888|OTHER|||||||0.0016||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0016
71835491|NCT06023082|143175889|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835492|NCT06023082|143175890|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835493|NCT06023082|143175891|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835494|NCT06023082|143175892|OTHER|||||||0.0002||||||Baseline to Week 12 comparison.|ANOVA|||||||0.0002
71835495|NCT06023082|143175893|OTHER|||||||0.001||||||Baseline to Week 12 comparison.|ANOVA|||||||0.001
71835496|NCT06023082|143175894|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835497|NCT06023082|143175895|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835498|NCT06023082|143175896|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835499|NCT06023082|143175897|OTHER||||||<|0.0001|||||||ANOVA|||Baseline to Week 12 comparison.||||<0.0001
71835500|NCT06023082|143175898|OTHER||||||<|0.0001||||||Baseline to Week 10 comparison.|ANOVA|||||||<0.0001
71835501|NCT06023082|143175899|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835502|NCT06023082|143175900|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835503|NCT06023082|143175901|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835504|NCT06023082|143175902|OTHER||||||<|0.0001||||||Baseline to Week 12 comparison.|ANOVA|||||||<0.0001
71835505|NCT05136404|143175904|OTHER||Ratio of Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.937|1.08|||Mixed Models Analysis|||||1.08|0.937|
71668419|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.31|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.||1.62|0.31|
71668420|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.41|1.4|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.||1.40|0.41|
71668421|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.57|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.||1.57|0.51|
71668422|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.51|1.68|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.||1.68|0.51|
71782255|NCT04115839|143063938|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
71668423|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.68|2.19|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.||2.19|0.68|
71668424|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.44|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).||1.62|0.44|
71668425|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.44|7.2|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.||7.20|0.44|
71668426|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.52|3.86|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.||3.86|0.52|
71668427|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.51|1.87|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.||1.87|0.51|
71668428|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.5|1.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.||1.50|0.50|
71668429|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.52|1.69|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.||1.69|0.52|
71668430|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|0.93|3.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.||3.50|0.93|
71668431|NCT01526057|142853370|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.51|1.89|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).||1.89|0.51|
71668432|NCT02289729|142853379|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668433|NCT02289729|142853380|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71782256|NCT04115839|143063938|SUPERIORITY||Difference in response rates|3.1|||||TWO_SIDED|95.0|-5.9|12.2|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||12.2|-5.9|
71782257|NCT04115839|143063938|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 8||2.9|-2.9|
71668434|NCT02289729|142853381|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71782258|NCT04115839|143063938|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-5.8|11.9|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||11.9|-5.8|
71782259|NCT04115839|143063938|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-5.0|16.7|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 12||16.7|-5.0|
71668435|NCT02289729|142853382|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668436|NCT02289729|142853383|SUPERIORITY|||||||0.0328|||||||t-test|||||||0.0328
71668437|NCT02289729|142853384|SUPERIORITY|||||||0.4183|||||||t-test|||||||0.4183
71668438|NCT02289729|142853385|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668439|NCT02289729|142853386|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
71668440|NCT02289729|142853387|SUPERIORITY|||||||0.0109|||||||t-test|||||||0.0109
71668441|NCT02289729|142853388|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
71668442|NCT02289729|142853389|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668443|NCT02289729|142853390|SUPERIORITY|||||||0.0002|||||||signed-rank test|||||||0.0002
71668444|NCT02289729|142853391|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668445|NCT02289729|142853392|SUPERIORITY|||||||0.0038|||||||t-test|||||||0.0038
71668446|NCT02289729|142853393|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71668447|NCT02289729|142853394|SUPERIORITY|||||||0.0274|||||||signed-rank test|||||||0.0274
71668448|NCT02289729|142853395|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71668449|NCT02289729|142853396|SUPERIORITY|||||||0.0006|||||||t-test|||||||0.0006
71668450|NCT02289729|142853397|SUPERIORITY|||||||0.001|||||||signed-rank test|||||||0.0010
71668451|NCT02289729|142853398|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
71668452|NCT02289729|142853399|SUPERIORITY|||||||0.0297|||||||t-test|||||||0.0297
71668453|NCT02289729|142853400|SUPERIORITY|||||||0.0279|||||||t-test|||||||0.0279
71668454|NCT02289729|142853401|SUPERIORITY|||||||0.2777|||||||t-test|||||||0.2777
71782260|NCT04115839|143063938|SUPERIORITY||Difference in response rates|0.1|||||TWO_SIDED|95.0|-11.4|11.6|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||11.6|-11.4|
71782261|NCT04115839|143063938|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-10.0|16.1|||||95% CI for response rate and difference in response rates were based on normal approximation method with a continuity correction.|Week 16||16.1|-10.0|
71782262|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.24|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from mixed-effects model for repeated measures (MMRM) having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.24
71835506|NCT05136404|143175904|OTHER||Ratio of Geometric Least Squares Mean|1.04|||||TWO_SIDED|90.0|0.968|1.11|||Mixed Models Analysis|||||1.11|0.968|
71835507|NCT05136404|143175905|OTHER||Ratio of Geometric Least Squares Mean|0.989|||||TWO_SIDED|90.0|0.953|1.03|||Mixed Models Analysis|||||1.03|0.953|
71668455|NCT02289729|142853402|SUPERIORITY|||||||0.0047|||||||t-test|||||||0.0047
71668456|NCT02289729|142853403|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
71750061|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.38||||0.5308|TWO_SIDED|95.0|0.5|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.77|0.50|0.5308
71750062|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8603|TWO_SIDED|95.0|0.41|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||2.90|0.41|0.8603
71750063|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.73||||0.0264|TWO_SIDED|95.0|1.17|11.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.95|1.17|0.0264
71750064|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.6||||0.0188|TWO_SIDED|95.0|1.29|16.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.42|1.29|0.0188
71750065|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7642|TWO_SIDED|95.0|0.42|3.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.27|0.42|0.7642
71750066|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.91||||0.0101|TWO_SIDED|95.0|1.46|16.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.53|1.46|0.0101
71782263|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.22|TWO_SIDED|95.0|-1.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0|-1|0.22
71750067|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0572|TWO_SIDED|95.0|0.97|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.97|0.0572
71750068|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7348|TWO_SIDED|95.0|0.44|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.20|0.44|0.7348
71750069|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1397|TWO_SIDED|95.0|0.77|6.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.25|0.77|0.1397
71750070|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.07||||0.0231|TWO_SIDED|95.0|1.21|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||13.64|1.21|0.0231
71750071|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.54||||0.0196|TWO_SIDED|95.0|1.27|16.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.15|1.27|0.0196
71782264|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.43
71782265|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.7|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||1|-1|0.70
71668457|NCT02289729|142853404|SUPERIORITY||||||<|0.5877|||||||t-test|||||||<0.5877
71668458|NCT02289729|142853405|SUPERIORITY|||||||0.0002|||||||t-test|||||||0.0002
71668459|NCT02289729|142853406|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
71782266|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.1|TWO_SIDED|95.0|-2.0|0.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0|-2|0.10
71782267|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||1|-1|0.90
71668460|NCT02289729|142853407|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668461|NCT02289729|142853408|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71668462|NCT02289729|142853409|SUPERIORITY||||||<|0.0001|||||||t-test|||||||< 0.0001
71668463|NCT02289729|142853410|SUPERIORITY|||||||0.0001|||||||t-test|||||||0.0001
71668464|NCT02289729|142853411|SUPERIORITY||||||<|0.0001|||||||signed-rank test|||||||< 0.0001
71668465|NCT02289729|142853412|SUPERIORITY|||||||0.2428|||||||signed-rank test|||||||0.2428
71668466|NCT02289729|142853413|SUPERIORITY|||||||0.0687|||||||t-test|||||||0.0687
71668467|NCT02289729|142853414|SUPERIORITY|||||||0.3126|||||||t-test|||||||0.3126
71782268|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.88|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.88
71750072|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7703|TWO_SIDED|95.0|0.42|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||3.24|0.42|0.7703
71750073|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.83||||0.0222|TWO_SIDED|95.0|1.21|12.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.12|1.21|0.0222
71750074|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0668|TWO_SIDED|95.0|0.93|8.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.21|0.93|0.0668
71750075|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7533|TWO_SIDED|95.0|0.43|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.22|0.43|0.7533
71750076|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3325|TWO_SIDED|95.0|0.59|4.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.73|0.59|0.3325
71750077|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.71||||0.0899|TWO_SIDED|95.0|0.86|8.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||8.57|0.86|0.0899
71782269|NCT04115839|143063946|SUPERIORITY||LS Mean Treatment Difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.89|TWO_SIDED|95.0|-1.0|1.0||P-value was provided from MMRM having treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||1|-1|0.89
71668468|NCT02289729|142853415|SUPERIORITY|||||||0.1533|||||||t-test|||||||0.1533
71750078|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0642|TWO_SIDED|95.0|0.93|11.79||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.79|0.93|0.0642
71750079|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.34||||0.5964|TWO_SIDED|95.0|0.46|3.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.89|0.46|0.5964
71750080|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.43||||0.0224|TWO_SIDED|95.0|1.23|15.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||15.91|1.23|0.0224
71750081|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.72||||0.3139|TWO_SIDED|95.0|0.6|4.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.96|0.60|0.3139
71750082|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6343|TWO_SIDED|95.0|0.45|3.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.76|0.45|0.6343
71750083|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.27||||0.6557|TWO_SIDED|95.0|0.45|3.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.61|0.45|0.6557
71668469|NCT02289729|142853416|SUPERIORITY|||||||0.8145|||||||t-test|||||||0.8145
71750084|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0516|TWO_SIDED|95.0|0.99|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.51|0.99|0.0516
71782270|NCT04115839|143063950|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-15.9|16.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||16.5|-15.9|
71782271|NCT04115839|143063950|SUPERIORITY||Difference in response rates|12.6|||||TWO_SIDED|95.0|-7.1|32.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.3|-7.1|
71668470|NCT02289729|142853417|SUPERIORITY|||||||0.4048|||||||t-test|||||||0.4048
71668471|NCT02289729|142853418|SUPERIORITY|||||||0.8321|||||||t-test|||||||0.8321
71668472|NCT02289729|142853419|SUPERIORITY|||||||0.1945|||||||signed-rank test|||||||0.1945
71668473|NCT02289729|142853420|SUPERIORITY|||||||0.7937|||||||t-test|||||||0.7937
71668474|NCT02289729|142853421|SUPERIORITY|||||||0.0234|||||||signed-rank test|||||||0.0234
71668475|NCT02289729|142853422|SUPERIORITY|||||||0.5922|||||||t-test|||||||0.5922
71668476|NCT02289729|142853423|SUPERIORITY|||||||1|||||||t-test|||||||1.000
71668477|NCT02289729|142853424|SUPERIORITY|||||||0.6481|||||||t-test|||||||0.6481
71668478|NCT02289729|142853425|SUPERIORITY|||||||0.6741|||||||t-test|||||||0.6741
71668479|NCT02289729|142853426|OTHER||Fisher's z|0.27846||||0.0389|TWO_SIDED|95.0|0.014175|0.495059|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.495059|0.014175|0.0389
71668480|NCT02289729|142853426|OTHER||Fisher's z|0.07359||||0.5852|TWO_SIDED|95.0|-0.188409|0.32558|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.325580|-0.188409|0.5852
71668481|NCT02289729|142853426|OTHER||Fisher's z|0.21311||||0.114|TWO_SIDED|95.0|-0.051127|0.444152|||Fisher's z Transformation|||PDQ-39 with NMSS||0.444152|-0.051127|0.1140
71668482|NCT02289729|142853426|OTHER||Fisher's z|0.29062||||0.0311|TWO_SIDED|95.0|0.026334|0.504186|||Fisher's z Transformation|||PDQ-39 with BAI||0.504186|0.026334|0.0311
71782272|NCT04115839|143063950|SUPERIORITY||Difference in response rates|26.6|||||TWO_SIDED|95.0|3.0|50.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||50.2|3.0|
71782273|NCT04115839|143063950|SUPERIORITY||Difference in response rates|18.2|||||TWO_SIDED|95.0|-4.1|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||40.4|-4.1|
71668483|NCT02289729|142853426|OTHER||Fisher's z|0.49952||||0.0002|TWO_SIDED|95.0|0.230995|0.643312|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.643312|0.230995|0.0002
71668484|NCT02289729|142853426|OTHER||Fisher's z|0.08869||||0.5146|TWO_SIDED|95.0|-0.176169|0.341163|||Fisher's z Transformation|||PDQ-39 with AS||0.341163|-0.176169|0.5146
71668485|NCT02289729|142853426|OTHER||Fisher's z|0.34688||||0.0108|TWO_SIDED|95.0|0.079996|0.546657|||Fisher's z Transformation|||PDQ-39 with PFS||0.546657|0.079996|0.0108
71668486|NCT02289729|142853426|OTHER||Fisher's z|0.22455||||0.0989|TWO_SIDED|95.0|-0.042139|0.455224|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.455224|-0.042139|0.0989
71668487|NCT02289729|142853426|OTHER||Fisher's z|0.35742||||0.006|TWO_SIDED|95.0|0.106797|0.565335|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.565335|0.106797|0.0060
71668488|NCT02289729|142853426|OTHER||Fisher's z|0.00011||||0.9993|TWO_SIDED|95.0|-0.260462|0.260673|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.260673|-0.260462|0.9993
71668489|NCT02289729|142853426|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.092154|-0.565795|0.0088
71668490|NCT02289729|142853426|OTHER||Fisher's z|0.21643||||0.1222|TWO_SIDED|95.0|-0.057959|0.454911|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.454911|-0.057959|0.1222
71668491|NCT02289729|142853426|OTHER||Fisher's z|0.57423||||0.0041|TWO_SIDED|95.0|0.180247|0.74704|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.747040|0.180247|0.0041
71668492|NCT02289729|142853427|OTHER||Fisher's z|0.31946||||0.0239|TWO_SIDED|95.0|0.042257|0.534657|||Fisher's z Transformation|||PDQ-39 with UPDRS-III||0.534657|0.042257|0.0239
71668493|NCT02289729|142853427|OTHER||Fisher's z|0.36796||||0.0093|TWO_SIDED|95.0|0.090528|0.568388|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV||0.568388|0.090528|0.0093
71668494|NCT02289729|142853427|OTHER||Fisher's z|0.38627||||0.0069|TWO_SIDED|95.0|0.105875|0.582517|||Fisher's z Transformation|||PDQ-39 with NMSS||0.582517|0.105875|0.0069
71668495|NCT02289729|142853427|OTHER||Fisher's z|0.70289|||<|0.0001|TWO_SIDED|95.0|0.40173|0.753097|||Fisher's z Transformation|||PDQ-39 with BAI||0.753097|0.401730|< 0.0001
71668496|NCT02289729|142853427|OTHER||Fisher's z|0.63758|||<|0.0001|TWO_SIDED|95.0|0.345567|0.72341|||Fisher's z Transformation|||PDQ-39 with BDI-II||0.723410|0.345567|<0.0001
71668497|NCT02289729|142853427|OTHER||Fisher's z|0.24114||||0.0882|TWO_SIDED|95.0|-0.036024|0.476404|||Fisher's z Transformation|||PDQ-39 with AS||0.476404|-0.036024|0.0882
71668498|NCT02289729|142853427|OTHER||Fisher's z|0.67113|||<|0.0001|TWO_SIDED|95.0|0.374757|0.739016|||Fisher's z Transformation|||PDQ-39 with PFS||0.739016|0.374757|< 0.0001
71668499|NCT02289729|142853427|OTHER||Fisher's z|0.60612|||<|0.0001|TWO_SIDED|95.0|0.317572|0.708072|||Fisher's z Transformation|||PDQ-39 with NBL A-S||0.708072|0.317572|< 0.0001
71668500|NCT02289729|142853427|OTHER||Fisher's z|0.60613|||<|0.0001|TWO_SIDED|95.0|0.31758|0.708076|||Fisher's z Transformation|||PDQ-39 with NBL C-D||0.708076|0.317580|< 0.0001
71668501|NCT02289729|142853427|OTHER||Fisher's z|0.41143||||0.0036|TWO_SIDED|95.0|0.133445|0.597087|||Fisher's z Transformation|||PDQ-39 with NBL C-R||0.597087|0.133445|0.0036
71668502|NCT02289729|142853427|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||PDQ-39 with ZBI||-0.044411|-0.557217|0.0239
71668503|NCT02289729|142853427|OTHER||Fisher's z|0.64565|||<|0.0001|TWO_SIDED|95.0|0.339454|0.734221|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety||0.734221|0.339454|< 0.0001
71668504|NCT02289729|142853427|OTHER||Fisher's z|0.10898||||0.7058|TWO_SIDED|95.0|-0.427482|0.588111|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression||0.588111|-0.427482|0.7058
71668505|NCT02289729|142853428|OTHER||Fisher's z|-0.57271|||<|0.0001|TWO_SIDED|95.0|-0.689585|-0.289724|||Fisher's z Transformation|||SQLC with ZBI||-0.289724|-0.689585|< 0.0001
71668506|NCT02289729|142853428|OTHER||Fisher's z|-0.16332||||0.4142|TWO_SIDED|95.0|-0.504489|0.224771|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.224771|-0.504489|0.4142
71668507|NCT02289729|142853428|OTHER||Fisher's z|-0.48143||||0.0239|TWO_SIDED|95.0|-0.715956|-0.063481|||Fisher's z Transformation|||SQLC with Goldberg Depression||-0.063481|-0.715956|0.0239
71668508|NCT02289729|142853428|OTHER||Fisher's z|0.06326||||0.6546|TWO_SIDED|95.0|-0.210715|0.327872|||Fisher's z Transformation|||SQLC with NBL A-S||0.327872|-0.210715|0.6546
71782274|NCT04115839|143063952|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.5|-5.6|
71782275|NCT04115839|143063952|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
71835508|NCT05136404|143175905|OTHER||Ratio of Geometric Least Squares Mean|1.02|||||TWO_SIDED|90.0|0.982|1.06|||Mixed Models Analysis|||||1.06|0.982|
71782276|NCT04115839|143063952|SUPERIORITY||Difference in response rates|12.9|||||TWO_SIDED|95.0|-2.0|27.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.8|-2.0|
71782277|NCT04115839|143063952|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
71782278|NCT04115839|143063954|SUPERIORITY||Difference in response rates|15.4||||0.098|TWO_SIDED|95.0|-5.5|36.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||36.3|-5.5|0.098
71782279|NCT04115839|143063954|SUPERIORITY||Difference in response rates|-5.1||||0.4|TWO_SIDED|95.0|-21.1|11.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.0|-21.1|0.40
71782280|NCT04115839|143063954|SUPERIORITY||Difference in response rates|10.8||||0.26|TWO_SIDED|95.0|-12.6|34.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.3|-12.6|0.26
71782281|NCT04115839|143063954|SUPERIORITY||Difference in response rates|8.8||||0.39|TWO_SIDED|95.0|-14.6|32.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||32.2|-14.6|0.39
71782282|NCT04115839|143063954|SUPERIORITY||Difference in response rates|20.0||||0.088|TWO_SIDED|95.0|-6.9|46.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.9|-6.9|0.088
71782283|NCT04115839|143063954|SUPERIORITY||Difference in response rates|-7.0||||0.49|TWO_SIDED|95.0|-32.9|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||18.9|-32.9|0.49
71782284|NCT04115839|143063954|SUPERIORITY||Difference in response rates|28.3||||0.019|TWO_SIDED|95.0|2.4|54.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||54.2|2.4|0.019
71782285|NCT04115839|143063954|SUPERIORITY||Difference in response rates|2.9||||0.85|TWO_SIDED|95.0|-22.5|28.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||28.4|-22.5|0.85
71782286|NCT04115839|143063954|SUPERIORITY||Difference in response rates|25.9||||0.036|TWO_SIDED|95.0|-0.4|52.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||52.3|-0.4|0.036
71782287|NCT04115839|143063954|SUPERIORITY||Difference in response rates|6.1||||0.6|TWO_SIDED|95.0|-19.7|31.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.8|-19.7|0.60
71782288|NCT04115839|143063956|SUPERIORITY||Difference in response rates|6.0||||0.31|TWO_SIDED|95.0|-7.8|19.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||19.8|-7.8|0.31
71835509|NCT05136404|143175906|OTHER||Ratio of Geometric Least Squares Mean|1.01|||||TWO_SIDED|90.0|0.972|1.06|||Mixed Models Analysis|||||1.06|0.972|
71668509|NCT02289729|142853428|OTHER||Fisher's z|0.17674||||0.2114|TWO_SIDED|95.0|-0.100105|0.425116|||Fisher's z Transformation|||SQLC with NBL C-D||0.425116|-0.100105|0.2114
71782289|NCT04115839|143063956|SUPERIORITY||Difference in response rates|-2.8||||0.48|TWO_SIDED|95.0|-11.1|5.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||5.5|-11.1|0.48
71835510|NCT05136404|143175906|OTHER||Ratio of Geometric Least Squares Mean|1.03|||||TWO_SIDED|90.0|0.992|1.08|||Mixed Models Analysis|||||1.08|0.992|
71835511|NCT05136404|143175907|SUPERIORITY||Median Difference (Final Values)|0.0||||0.4728|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.4728
71835512|NCT05136404|143175907|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0142|TWO_SIDED|90.0|-0.5|0.0|||Sign test|||||0.00|-0.50|0.0142
71835513|NCT05343390|143175964|SUPERIORITY||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|16.1|25.1|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||25.1|16.1|<0.001
71782290|NCT04115839|143063956|SUPERIORITY||Difference in response rates|2.5||||0.7|TWO_SIDED|95.0|-14.1|19.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||19.2|-14.1|0.70
71668510|NCT02289729|142853428|OTHER||Fisher's z|0.2944||||0.0374|TWO_SIDED|95.0|0.017222|0.516523|||Fisher's z Transformation|||SQLC with NBL C-R||0.516523|0.017222|0.0374
71782291|NCT04115839|143063956|SUPERIORITY||Difference in response rates|-8.6||||0.17|TWO_SIDED|95.0|-20.7|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||3.6|-20.7|0.17
71782292|NCT04115839|143063956|SUPERIORITY||Difference in response rates|6.5||||0.34|TWO_SIDED|95.0|-12.5|25.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||25.6|-12.5|0.34
71782293|NCT04115839|143063956|SUPERIORITY||Difference in response rates|-0.3||||0.98|TWO_SIDED|95.0|-16.9|16.4||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||16.4|-16.9|0.98
71782294|NCT04115839|143063956|SUPERIORITY||Difference in response rates|18.7||||0.071|TWO_SIDED|95.0|-5.1|42.5||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.5|-5.1|0.071
71782295|NCT04115839|143063956|SUPERIORITY||Difference in response rates|-8.8||||0.27|TWO_SIDED|95.0|-27.7|10.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||10.1|-27.7|0.27
71782296|NCT04115839|143063956|SUPERIORITY||Difference in response rates|40.7||||0.002|TWO_SIDED|95.0|19.5|62.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.0|19.5|0.002
71782297|NCT04115839|143063956|SUPERIORITY||Difference in response rates|15.2||||0.082|TWO_SIDED|95.0|-2.3|32.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-2.3|0.082
71782298|NCT04115839|143063958|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-5.6|11.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||11.5|-5.6|
71782299|NCT04115839|143063958|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||2.9|-2.9|
71782300|NCT04115839|143063958|SUPERIORITY||Difference in response rates|2.8|||||TWO_SIDED|95.0|-5.4|11.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||11.0|-5.4|
71782301|NCT04115839|143063958|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-2.9|2.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||2.9|-2.9|
71782302|NCT04115839|143063958|SUPERIORITY||Difference in response rates|12.7|||||TWO_SIDED|95.0|-4.2|29.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||29.5|-4.2|
71782303|NCT04115839|143063958|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-11.6|5.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||5.7|-11.6|
71782304|NCT04115839|143063958|SUPERIORITY||Difference in response rates|18.3|||||TWO_SIDED|95.0|0.2|36.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||36.3|0.2|
71668511|NCT02289729|142853428|OTHER||Fisher's z|-0.36687||||0.0088|TWO_SIDED|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.092154|-0.565795|0.0088
71668512|NCT02289729|142853428|OTHER||Fisher's z|-0.13433||||0.3374|TWO_SIDED|95.0|-0.387439|0.139207|||Fisher's z Transformation|||SQLC with UPDRS-III||0.139207|-0.387439|0.3374
71782305|NCT04115839|143063958|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.6|-9.7|
71782306|NCT04115839|143063958|SUPERIORITY||Difference in response rates|12.5|||||TWO_SIDED|95.0|-2.0|27.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||27.0|-2.0|
71782307|NCT04115839|143063958|SUPERIORITY||Difference in response rates|9.1|||||TWO_SIDED|95.0|-3.7|21.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||21.9|-3.7|
71668513|NCT02289729|142853428|OTHER||Fisher's z|0.17846||||0.2025|TWO_SIDED|95.0|-0.095693|0.424291|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.424291|-0.095693|0.2025
71668514|NCT02289729|142853428|OTHER||Fisher's z|0.01625||||0.9076|TWO_SIDED|95.0|-0.252613|0.282777|||Fisher's z Transformation|||SQLC with Global NMSS||0.282777|-0.252613|0.9076
71668515|NCT02289729|142853429|OTHER||Fisher's z|-0.7468|||<|0.0001|TWO_SIDED|95.0|-0.777482|-0.425693|||Fisher's z Transformation|||SQLC with ZBI||-0.425693|-0.777482|< 0.0001
71668516|NCT02289729|142853429|OTHER||Fisher's z|0.17924||||0.5347|TWO_SIDED|95.0|-0.368382|0.632178|||Fisher's z Transformation|||SQLC with Goldberg Anxiety||0.632178|-0.368382|0.5347
71668517|NCT02289729|142853429|OTHER||Fisher's z|-0.06987||||0.8251|TWO_SIDED|95.0|-0.597767|0.500464|||Fisher's z Transformation|||SQLC with Goldberg Depression||0.500464|-0.597767|0.8251
71668518|NCT02289729|142853429|OTHER||Fisher's z|-0.1106||||0.4581|TWO_SIDED|95.0|-0.382323|0.179601|||Fisher's z transformation|||SQLC with NBL A-S||0.179601|-0.382323|0.4581
71668519|NCT02289729|142853429|OTHER||Fisher's z|0.00326||||0.9826|TWO_SIDED|95.0|-0.281136|0.287128|||Fisher's z Transformation|||SQLC with NBL C-D||0.287128|-0.281136|0.9826
71782308|NCT04115839|143063974|SUPERIORITY||Difference in response rates|9.5|||||TWO_SIDED|95.0|-10.4|29.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||29.4|-10.4|
71782309|NCT04115839|143063974|SUPERIORITY||Difference in response rates|7.1|||||TWO_SIDED|95.0|-12.5|26.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||26.7|-12.5|
71668520|NCT02289729|142853429|OTHER||Fisher's z|-0.10293||||0.4899|TWO_SIDED|95.0|-0.375749|0.187021|||Fisher's z Transformation|||SQLC with NBL C-R||0.187021|-0.375749|0.4899
71668521|NCT02289729|142853429|OTHER||Fisher's z|-0.33661||||0.0239|TWO_SIDED|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||SQLC with Global PDQ-39||-0.044411|-0.557217|0.0239
71668522|NCT02289729|142853429|OTHER||Fisher's z|-0.23658||||0.1125|TWO_SIDED|95.0|-0.484427|0.055538|||Fisher's z Transformation|||SQLC with UPDRS-III||0.055538|-0.484427|0.1125
71668523|NCT02289729|142853429|OTHER||Fisher's z|-0.13015||||0.3826|TWO_SIDED|95.0|-0.398887|0.16062|||Fisher's z Transformation|||SQLC with UPDRS-IV||0.160620|-0.398887|0.3826
71782310|NCT04115839|143063974|SUPERIORITY||Difference in response rates|20.0|||||TWO_SIDED|95.0|-3.8|43.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||43.8|-3.8|
71782311|NCT04115839|143063974|SUPERIORITY||Difference in response rates|6.5|||||TWO_SIDED|95.0|-16.3|29.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||29.3|-16.3|
71782312|NCT04115839|143063974|SUPERIORITY||Difference in response rates|17.8|||||TWO_SIDED|95.0|-8.8|44.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||44.5|-8.8|
71782313|NCT04115839|143063974|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-22.9|28.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||28.8|-22.9|
71782314|NCT04115839|143063974|SUPERIORITY||Difference in response rates|25.0|||||TWO_SIDED|95.0|-0.5|50.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||50.6|-0.5|
71668524|NCT02289729|142853429|OTHER||Fisher's z|0.11688||||0.4382|TWO_SIDED|95.0|-0.176724|0.390468|||Fisher's z Transformation|||SQLC with Global NMSS||0.390468|-0.176724|0.4382
71668525|NCT01875978|142853430|SUPERIORITY_OR_OTHER||||||<|0.05||||||P-value \<0.05 is significance meaningful.|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis: phytosterols improve metabolic status||||<0.05
71668526|NCT01875978|142853431|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Hypothesis: phytosterols increase the anti-oxidative capacity.||||<0.05
71668527|NCT01875978|142853432|SUPERIORITY_OR_OTHER||||||<|0.05||||||P\<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Phytosterols increase IGF-1||||<0.05
71668528|NCT01875978|142853433|SUPERIORITY_OR_OTHER||||||<|0.05||||||P value \<0.05 for statistical significance|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis:phytosterols increase endothelial progenitor cells to provide endothelial repair and vessel protection||||<0.05
71668529|NCT04870710|142853441|SUPERIORITY||Median Difference (Net)|0.1||||0.1|TWO_SIDED||||||Friedman||||Non-parametric tests were used consisting of Friedman and Durbin Conover tests|||0.10
71668530|NCT05724589|142853462|SUPERIORITY|A repeated measures ANOVA was selected to analyze changes in skin hydration across four time points within the same participants..|Mean Difference (Final Values)|2.671||||1|TWO_SIDED|||||The p-value reflects the overall test for difference in hydration over time and is not adjusted for multiple comparisons. The pre-defined threshold for statistical significance was p \< 0.05.|ANOVA|No additional adjustments were applied. Degrees of freedom and sphericity assumptions were checked.|The mean difference was calculated based on changes in skin hydration from baseline to Week 16 using repeated measures ANOVA, in accordance with the pre-specified statistical analysis plan.|Skin hydration was evaluated longitudinally using repeated measures ANOVA at Baseline, Week 8, Week 12, and Week 16. This pre-specified statistical test assessed within-subject changes over time to determine the efficacy of the serum.|The overall p-value corresponds to the repeated measures ANOVA evaluating changes over four time points. No multiplicity adjustments were applied.|||1.000
71782315|NCT04115839|143063974|SUPERIORITY||Difference in response rates|14.7|||||TWO_SIDED|95.0|-10.5|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||39.9|-10.5|
71782316|NCT04115839|143063974|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||45.6|-8.7|
71782317|NCT04115839|143063974|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-20.5|32.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||32.6|-20.5|
71782318|NCT04115839|143063976|SUPERIORITY||Difference in response rates|9.0|||||TWO_SIDED|95.0|-6.0|23.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||23.9|-6.0|
71782319|NCT04115839|143063976|SUPERIORITY||Difference in response rates|3.3|||||TWO_SIDED|95.0|-9.4|15.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||15.9|-9.4|
71782320|NCT04115839|143063976|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-14.7|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||26.2|-14.7|
71782321|NCT04115839|143063976|SUPERIORITY||Difference in response rates|-5.5|||||TWO_SIDED|95.0|-23.4|12.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||12.4|-23.4|
71782322|NCT04115839|143063976|SUPERIORITY||Difference in response rates|1.3|||||TWO_SIDED|95.0|-21.5|24.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||24.1|-21.5|
71782323|NCT04115839|143063976|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-22.2|22.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||22.2|-22.2|
71782324|NCT04115839|143063976|SUPERIORITY||Difference in response rates|21.6|||||TWO_SIDED|95.0|-0.8|43.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||43.9|-0.8|
71782325|NCT04115839|143063976|SUPERIORITY||Difference in response rates|20.6|||||TWO_SIDED|95.0|-1.4|42.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||42.6|-1.4|
71782326|NCT04115839|143063976|SUPERIORITY||Difference in response rates|17.5|||||TWO_SIDED|95.0|-7.7|42.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||42.7|-7.7|
71782327|NCT04115839|143063976|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-20.2|26.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||26.3|-20.2|
71782328|NCT04115839|143063979|SUPERIORITY||Difference in response rates|9.3|||||TWO_SIDED|95.0|-9.2|27.8||||||Week 2||27.8|-9.2|
71782329|NCT04115839|143063979|SUPERIORITY||Difference in response rates|3.8|||||TWO_SIDED|95.0|-13.5|21.0||||||Week 2||21.0|-13.5|
71782330|NCT04115839|143063979|SUPERIORITY||Difference in response rates|5.7|||||TWO_SIDED|95.0|-16.8|28.2||||||Week 4||28.2|-16.8|
71782331|NCT04115839|143063979|SUPERIORITY||Difference in response rates|-2.4|||||TWO_SIDED|95.0|-23.7|19.0||||||Week 4||19.0|-23.7|
71782332|NCT04115839|143063979|SUPERIORITY||Difference in response rates|5.3|||||TWO_SIDED|95.0|-21.1|31.8||||||Week 8||31.8|-21.1|
71782333|NCT04115839|143063979|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-31.0|19.3||||||Week 8||19.3|-31.0|
71782334|NCT04115839|143063979|SUPERIORITY||Difference in response rates|19.2|||||TWO_SIDED|95.0|-7.0|45.3||||||Week 12||45.3|-7.0|
71782335|NCT04115839|143063979|SUPERIORITY||Difference in response rates|8.8|||||TWO_SIDED|95.0|-16.9|34.6||||||Week 12||34.6|-16.9|
71782336|NCT04115839|143063979|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-8.7|45.6||||||Week 16||45.6|-8.7|
71782337|NCT04115839|143063979|SUPERIORITY||Difference in response rates|3.0|||||TWO_SIDED|95.0|-23.4|29.5||||||Week 16||29.5|-23.4|
71782338|NCT04115839|143063981|SUPERIORITY||Difference in response rates|-2.8|||||TWO_SIDED|95.0|-11.0|5.4||||||Week 2||5.4|-11.0|
71782339|NCT04115839|143063981|SUPERIORITY||Difference in response rates|0.3|||||TWO_SIDED|95.0|-10.6|11.1||||||Week 2||11.1|-10.6|
71782340|NCT04115839|143063981|SUPERIORITY||Difference in response rates|-2.9|||||TWO_SIDED|95.0|-15.2|9.5||||||Week 4||9.5|-15.2|
71782341|NCT04115839|143063981|SUPERIORITY||Difference in response rates|-5.7|||||TWO_SIDED|95.0|-16.3|4.9||||||Week 4||4.9|-16.3|
71782342|NCT04115839|143063981|SUPERIORITY||Difference in response rates|0.6|||||TWO_SIDED|95.0|-16.4|17.5||||||Week 8||17.5|-16.4|
71782343|NCT04115839|143063981|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-19.9|8.2||||||Week 8||8.2|-19.9|
71782344|NCT04115839|143063981|SUPERIORITY||Difference in response rates|12.2|||||TWO_SIDED|95.0|-4.3|28.7||||||Week 12||28.7|-4.3|
71782345|NCT04115839|143063981|SUPERIORITY||Difference in response rates|2.9|||||TWO_SIDED|95.0|-9.7|15.6||||||Week 12||15.6|-9.7|
71782346|NCT04115839|143063981|SUPERIORITY||Difference in response rates|13.1|||||TWO_SIDED|95.0|-4.2|30.4||||||Week 16||30.4|-4.2|
71782347|NCT04115839|143063981|SUPERIORITY||Difference in response rates|12.1|||||TWO_SIDED|95.0|-4.5|28.7||||||Week 16||28.7|-4.5|
71782348|NCT04115839|143063984|SUPERIORITY||Difference in response rates|18.5|||||TWO_SIDED|95.0|-3.8|40.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||40.7|-3.8|
71782349|NCT04115839|143063984|SUPERIORITY||Difference in response rates|7.3|||||TWO_SIDED|95.0|-13.5|28.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 2||28.2|-13.5|
71782350|NCT04115839|143063984|SUPERIORITY||Difference in response rates|16.0|||||TWO_SIDED|95.0|-8.5|40.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.4|-8.5|
71782351|NCT04115839|143063984|SUPERIORITY||Difference in response rates|15.5|||||TWO_SIDED|95.0|-9.4|40.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||40.3|-9.4|
71782352|NCT04115839|143063984|SUPERIORITY||Difference in response rates|18.8|||||TWO_SIDED|95.0|-7.5|45.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||45.0|-7.5|
71782353|NCT04115839|143063984|SUPERIORITY||Difference in response rates|-5.9|||||TWO_SIDED|95.0|-32.5|20.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||20.7|-32.5|
71782354|NCT04115839|143063984|SUPERIORITY||Difference in response rates|40.5|||||TWO_SIDED|95.0|15.8|65.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||65.2|15.8|
71782355|NCT04115839|143063984|SUPERIORITY||Difference in response rates|23.5|||||TWO_SIDED|95.0|-2.5|49.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||49.5|-2.5|
71782356|NCT04115839|143063984|SUPERIORITY||Difference in response rates|20.1|||||TWO_SIDED|95.0|-6.8|46.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||46.9|-6.8|
71782357|NCT04115839|143063984|SUPERIORITY||Difference in response rates|6.1|||||TWO_SIDED|95.0|-21.0|33.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||33.1|-21.0|
71668531|NCT05724589|142853463|SUPERIORITY|The statistical analysis in this study to assess changes in Transepidermal Water Loss (TEWL) after serum application involved a repeated measures analysis of variance (ANOVA). This approach allows for the examination of differences in TEWL across multiple time points (baseline, 8 weeks, 12 weeks, and 16 weeks) within the same individuals. The use of repeated measures ANOVA accounts for the correlated nature of the data, as multiple measurements are obtained from each participant over time.|Mean Difference (Final Values)|-3.656||||0.096|TWO_SIDED|||||A repeated measures ANOVA was used to assess changes in hydration over time. The mean difference between baseline and 16 weeks was -3.656 (arbitrary units). Results are presented in the corresponding outcome measure table.|ANOVA|||||||0.096
71782358|NCT04115839|143063988|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-31.0|31.0|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||31.0|-31.0|
71782359|NCT04115839|143063988|SUPERIORITY||Difference in response rates|22.0|||||TWO_SIDED|95.0|-12.8|56.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||56.7|-12.8|
71782360|NCT04115839|143063988|SUPERIORITY||Difference in response rates|4.3|||||TWO_SIDED|95.0|-37.9|46.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.5|-37.9|
71782361|NCT04115839|143063988|SUPERIORITY||Difference in response rates|5.5|||||TWO_SIDED|95.0|-35.4|46.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||46.3|-35.4|
71782362|NCT04115839|143063988|SUPERIORITY||Difference in response rates|17.1|||||TWO_SIDED|95.0|-25.6|59.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||59.9|-25.6|
71782363|NCT04115839|143063988|SUPERIORITY||Difference in response rates|-13.4|||||TWO_SIDED|95.0|-53.7|26.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||26.8|-53.7|
71782364|NCT04115839|143063988|SUPERIORITY||Difference in response rates|28.6|||||TWO_SIDED|95.0|-14.1|71.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||71.2|-14.1|
71782365|NCT04115839|143063988|SUPERIORITY||Difference in response rates|-0.4|||||TWO_SIDED|95.0|-40.8|39.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||39.9|-40.8|
71782366|NCT04115839|143063990|SUPERIORITY||Difference in response rates|6.7||||0.55|TWO_SIDED|95.0|-21.3|34.7||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||34.7|-21.3|0.55
71782367|NCT04115839|143063990|SUPERIORITY||Difference in response rates|11.0||||0.24|TWO_SIDED|95.0|-17.4|39.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||39.3|-17.4|0.24
71782368|NCT04115839|143063990|SUPERIORITY||Difference in response rates|6.2||||0.47|TWO_SIDED|95.0|-22.6|35.0||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||35.0|-22.6|0.47
71782369|NCT04115839|143063990|SUPERIORITY||Difference in response rates|10.5||||0.25|TWO_SIDED|95.0|-18.6|39.6||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||39.6|-18.6|0.25
71782370|NCT04115839|143063990|SUPERIORITY||Difference in response rates|18.6||||0.44|TWO_SIDED|95.0|-21.1|58.3||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||58.3|-21.1|0.44
71782371|NCT04115839|143063990|SUPERIORITY||Difference in response rates|-3.8||||0.68|TWO_SIDED|95.0|-38.4|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||30.8|-38.4|0.68
71835514|NCT05343390|143175965|SUPERIORITY||Mean Difference (Final Values)|11.1|||<|0.001|TWO_SIDED|95.0|5.9|16.4|||Regression, Linear|A linear model fit using generalized estimating equations to account for correlated observations within clusters.||||16.4|5.9|<0.001
71835515|NCT05343390|143175966|SUPERIORITY||Rate Ratio|1.22||||0.14|TWO_SIDED|95.0|0.93|1.6|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.60|0.93|0.14
71835516|NCT05343390|143175967|SUPERIORITY||Rate Ratio|1.37||||0.006|TWO_SIDED|95.0|1.1|1.71|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.71|1.10|0.006
71835517|NCT05343390|143175968|SUPERIORITY||Rate Ratio|2.29||||0.013|TWO_SIDED|95.0|1.19|4.4|||Mixed Models Analysis|Negative binomial mixed-effect model||||4.40|1.19|0.013
71835518|NCT05343390|143175969|SUPERIORITY||Rate Ratio|1.45||||0.01|TWO_SIDED|95.0|1.1|1.92|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.92|1.10|0.01
71835519|NCT05343390|143175970|SUPERIORITY||Rate Ratio|1.28||||0.12|TWO_SIDED|95.0|0.94|1.76|||Mixed Models Analysis|Negative binomial mixed-effect model||||1.76|0.94|0.12
71835520|NCT05623345|143176036|SUPERIORITY||Risk Difference (RD)|36.22|STANDARD_ERROR_OF_MEAN|17.43||0.0377|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0377
71835521|NCT05623345|143176036|SUPERIORITY||Risk Difference (RD)|27.69|STANDARD_ERROR_OF_MEAN|5.68|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835522|NCT05623345|143176036|SUPERIORITY||Risk Difference (RD)|24.44|STANDARD_ERROR_OF_MEAN|5.65|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71668532|NCT05724589|142853464|SUPERIORITY|The chosen test was designed to assess whether application of the intervention resulted in any statistically significant differences over time in the primary outcome measure, assuming superiority.|Mean Difference (Final Values)|-0.043||||0.169|TWO_SIDED|||||The pre-specified significance threshold was set at p \< 0.05. No adjustments for multiple comparisons were applied.|ANOVA|Sphericity tested; Greenhouse-Geisser applied if needed. Repeated measures ANOVA accounted for within-subject correlations.|The estimation parameter reflects the change in the R2 elasticity measure from baseline to 16 weeks. The direction of change is based on the final minus baseline value, with baseline serving as the reference point.|The statistical analysis utilized repeated measures ANOVA to evaluate changes in facial skin elasticity (R2 parameter) across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants. This approach accounts for the correlation of repeated measures over time.||||0.169
71668533|NCT05724589|142853465|SUPERIORITY|This study aimed to evaluate changes in wrinkle scores using a 4-grade percentage wrinkle improvement scale across different time points, including baseline, 8 weeks, 12 weeks, and 16 weeks|Mean Difference (Final Values)|1.0||||1|TWO_SIDED||||||ANOVA||The Mean Difference represents the change in wrinkle scores from baseline (Day 0) to follow-up at Week 8, Week 12, or Week 16. For example, a Mean Difference of 1.0 indicates a 1-point improvement from baseline to Week 16 (Week 16 - baseline score).|||||1.000
71782372|NCT04115839|143063990|SUPERIORITY||Difference in response rates|21.4||||0.33|TWO_SIDED|95.0|-19.4|62.2||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||62.2|-19.4|0.33
71835523|NCT05623345|143176037|SUPERIORITY||Risk Difference (RD)|43.71|STANDARD_ERROR_OF_MEAN|22.14||0.0483|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0483
71782373|NCT04115839|143063990|SUPERIORITY||Difference in response rates|2.1||||0.98|TWO_SIDED|95.0|-33.9|38.1||P-value was calculated from the logistic regression with treatment groups and stratification factors (geographic region, concurrent use of csDMARD(s) and/or apremilast at randomization, prior use of bioDMARD(s)) in the model.|Regression, Logistic||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||38.1|-33.9|0.98
71782374|NCT04115839|143063992|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-24.5|24.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||24.5|-24.5|
71782375|NCT04115839|143063992|SUPERIORITY||Difference in response rates|-0.8|||||TWO_SIDED|95.0|-23.9|22.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||22.4|-23.9|
71782376|NCT04115839|143063992|SUPERIORITY||Difference in response rates|13.3|||||TWO_SIDED|95.0|-10.8|37.4|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||37.4|-10.8|
71782377|NCT04115839|143063992|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
71782378|NCT04115839|143063992|SUPERIORITY||Difference in response rates|-14.8|||||TWO_SIDED|95.0|-46.6|17.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||17.1|-46.6|
71782379|NCT04115839|143063992|SUPERIORITY||Difference in response rates|-15.5|||||TWO_SIDED|95.0|-46.3|15.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||15.2|-46.3|
71782380|NCT04115839|143063992|SUPERIORITY||Difference in response rates|21.4|||||TWO_SIDED|95.0|-13.0|55.8|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||55.8|-13.0|
71782381|NCT04115839|143063992|SUPERIORITY||Difference in response rates|4.6|||||TWO_SIDED|95.0|-22.3|31.5|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||31.5|-22.3|
71782382|NCT04115839|143063994|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.7|6.7|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||6.7|-6.7|
71782383|NCT04115839|143063994|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.6|23.3|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 4||23.3|-11.6|
71782384|NCT04115839|143063994|SUPERIORITY||Difference in response rates|6.7|||||TWO_SIDED|95.0|-12.9|26.2|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||26.2|-12.9|
71782385|NCT04115839|143063994|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 8||23.6|-11.8|
71782386|NCT04115839|143063994|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-6.9|6.9|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||6.9|-6.9|
71782387|NCT04115839|143063994|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 12||23.6|-11.8|
71782388|NCT04115839|143063994|SUPERIORITY||Difference in response rates|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||7.1|-7.1|
71835524|NCT05623345|143176037|SUPERIORITY||Risk Difference (RD)|46.15|STANDARD_ERROR_OF_MEAN|7.62|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835525|NCT05623345|143176037|SUPERIORITY||Risk Difference (RD)|52.8|STANDARD_ERROR_OF_MEAN|7.56|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835526|NCT05623345|143176038|SUPERIORITY||Risk Difference (RD)|32.26|STANDARD_ERROR_OF_MEAN|18.93||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0883
71835527|NCT05623345|143176038|SUPERIORITY||Risk Difference (RD)|9.19|STANDARD_ERROR_OF_MEAN|8.35||0.2713|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2713
71782389|NCT04115839|143063994|SUPERIORITY||Difference in response rates|5.9|||||TWO_SIDED|95.0|-11.8|23.6|||||95% CI for difference in response rates were based on normal approximation method with a continuity correction.|Week 16||23.6|-11.8|
71782390|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.066||0.19|TWO_SIDED|95.0|-0.22|0.04||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.04|-0.22|0.19
71782391|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.067||0.84|TWO_SIDED|95.0|-0.15|0.12||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 2||0.12|-0.15|0.84
71782392|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.073||0.3|TWO_SIDED|95.0|-0.22|0.07||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.07|-0.22|0.30
71782393|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.074||0.89|TWO_SIDED|95.0|-0.14|0.16||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||0.16|-0.14|0.89
71782394|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.096||0.064|TWO_SIDED|95.0|-0.37|0.01||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.01|-0.37|0.064
71782395|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|0.01|STANDARD_ERROR_OF_MEAN|0.096||0.88|TWO_SIDED|95.0|-0.17|0.2||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 8||0.20|-0.17|0.88
71782396|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.099||0.023|TWO_SIDED|95.0|-0.43|-0.03||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||-0.03|-0.43|0.023
71782397|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.099||0.75|TWO_SIDED|95.0|-0.23|0.17||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 12||0.17|-0.23|0.75
71782398|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.005|TWO_SIDED|95.0|-0.51|-0.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||-0.10|-0.51|0.005
71782399|NCT04115839|143064002|SUPERIORITY||LS Mean Treatment Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.105||0.54|TWO_SIDED|95.0|-0.27|0.14||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||0.14|-0.27|0.54
71835528|NCT05623345|143176038|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|8.44||0.8872|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.8872
71782400|NCT04115839|143064004|SUPERIORITY||LS Mean Treatment Difference|1.3|STANDARD_ERROR_OF_MEAN|1.64||0.43|TWO_SIDED|95.0|-1.9|4.5||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||4.5|-1.9|0.43
71782401|NCT04115839|143064004|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.64||0.81|TWO_SIDED|95.0|-3.6|2.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||2.9|-3.6|0.81
71782402|NCT04115839|143064004|SUPERIORITY||LS Mean Treatment Difference|5.1|STANDARD_ERROR_OF_MEAN|2.43||0.04|TWO_SIDED|95.0|0.2|9.9||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||9.9|0.2|0.040
71782403|NCT04115839|143064004|SUPERIORITY||LS Mean Treatment Difference|1.4|STANDARD_ERROR_OF_MEAN|2.41||0.58|TWO_SIDED|95.0|-3.4|6.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.1|-3.4|0.58
71782404|NCT04115839|143064008|SUPERIORITY||LS Mean Treatment Difference|0.9|STANDARD_ERROR_OF_MEAN|1.09||0.4|TWO_SIDED|95.0|-1.2|3.1||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.1|-1.2|0.40
71782405|NCT04115839|143064008|SUPERIORITY||LS Mean Treatment Difference|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 4||3.4|-1.0|0.28
71782406|NCT04115839|143064008|SUPERIORITY||LS Mean Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.46||0.011|TWO_SIDED|95.0|0.9|6.7||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||6.7|0.9|0.011
71782407|NCT04115839|143064008|SUPERIORITY||LS Mean Treatment Difference|2.1|STANDARD_ERROR_OF_MEAN|1.45||0.14|TWO_SIDED|95.0|-0.7|5.0||P-value was provided from MMRM including treatment, visit (categorical), treatment by visit, stratification factors, baseline value as fixed effects, participants being the random effect.|MMRM|||Week 16||5.0|-0.7|0.14
71835529|NCT05623345|143176039|SUPERIORITY||Risk Difference (RD)|23.45|STANDARD_ERROR_OF_MEAN|16.9||0.1654|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1654
71835530|NCT05623345|143176039|SUPERIORITY||Risk Difference (RD)|26.58|STANDARD_ERROR_OF_MEAN|5.53|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835531|NCT05623345|143176039|SUPERIORITY||Risk Difference (RD)|25.84|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835532|NCT05623345|143176040|SUPERIORITY||Risk Difference (RD)|43.09|STANDARD_ERROR_OF_MEAN|16.85||0.0106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0106
71835533|NCT05623345|143176040|SUPERIORITY||Risk Difference (RD)|28.46|STANDARD_ERROR_OF_MEAN|6.22|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835534|NCT05623345|143176040|SUPERIORITY||Risk Difference (RD)|23.7|STANDARD_ERROR_OF_MEAN|6.4||0.0002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0002
71782408|NCT00621985|143064052|SUPERIORITY_OR_OTHER||Percent Difference|-19.0||||0.09||95.0|||||t-test, 2 sided|||"A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:~(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone"||||0.09
71782409|NCT02577510|143064055|OTHER|||||||0.05|||||||t-test, 1 sided|||Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon's signed ranks or McNemar's test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant||||0.05
71782410|NCT00706823|143064070|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||||||0.02
71782411|NCT00706823|143064071|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
71782412|NCT00706823|143064073|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||t-test, 2 sided|||||||0.22
71782413|NCT00706823|143064075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.11||||0.03|TWO_SIDED|95.0|1.1|58.6|||Regression, Logistic|||||58.6|1.1|0.03
71782414|NCT03416946|143064108|SUPERIORITY|||||||0.79||||||Post-op HKA angle|t-test, 2 sided|||||||0.790
71782415|NCT05673889|143064120|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|192.2|||||TWO_SIDED|90.0|166.56|221.79|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||221.79|166.56|
71835535|NCT05623345|143176041|SUPERIORITY||Risk Difference (RD)|30.15|STANDARD_ERROR_OF_MEAN|19.11||0.1147|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.1147
71782416|NCT05673889|143064121|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|197.81|||||TWO_SIDED|90.0|177.32|220.66|||||The ratios (and 90% CIs) are expressed as percentages.|Dabigatran etexilate administered alone as Reference, ARV-471 coadministered with dabigatran etexilate as Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||220.66|177.32|
71835536|NCT05623345|143176041|SUPERIORITY||Risk Difference (RD)|29.04|STANDARD_ERROR_OF_MEAN|5.92|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71835537|NCT05623345|143176041|SUPERIORITY||Risk Difference (RD)|24.99|STANDARD_ERROR_OF_MEAN|5.81|<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71782417|NCT00740831|143064126|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|1.2|||||ONE_SIDED|97.5|-9.3||||||Newcombe-Wilson method for CI. Percentage in A minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||-9.3|
71782418|NCT00740831|143064126|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|8.8|||||ONE_SIDED|97.5|0.4||||||Newcombe-Wilson method for CI. Percentage in B minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|||0.4|
71782419|NCT00740831|143064127|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.003|0.181||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.181|-0.003|
71835538|NCT05623345|143176042|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.166||0.514|TWO_SIDED|95.0|-0.22|0.44|||Mixed model repeated measures analysis|||||0.44|-0.22|0.514
71835539|NCT05623345|143176042|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.01|TWO_SIDED|95.0|-0.28|-0.04|||Mixed model repeated measures analysis|||||-0.04|-0.28|0.010
71835540|NCT05623345|143176042|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.006|TWO_SIDED|95.0|-0.29|-0.05|||Mixed model repeated measures analysis|||||-0.05|-0.29|0.006
71835541|NCT05384730|143176055|SUPERIORITY|||||||0.1|||||||ANOVA|||Light physical activity compared overtime||||0.10
71835542|NCT05384730|143176055|SUPERIORITY|||||||0.3|||||||ANOVA|||Moderate-vigorous physical activity compared overtime||||0.30
71835543|NCT05384730|143176055|SUPERIORITY|||||||0.18|||||||ANOVA|||Inactive/sedentary time compared overtime||||0.18
71835544|NCT05384730|143176056|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
71835545|NCT05384730|143176057|SUPERIORITY|||||||0.01|||||||ANOVA|||||||0.01
71835546|NCT05384730|143176058|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
71835547|NCT05384730|143176059|SUPERIORITY|||||||0.03|||||||Chi-squared|||Comparing depression scores overtime||||0.03
71835548|NCT05384730|143176059|SUPERIORITY|||||||0.96|||||||Chi-squared|||Comparing anxiety scores overtime||||0.96
71750085|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.38||||0.04|TWO_SIDED|95.0|1.07|17.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||17.91|1.07|0.0400
71750086|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5825|TWO_SIDED|95.0|0.44|4.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.24|0.44|0.5825
71750087|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|7.46||||0.0152|TWO_SIDED|95.0|1.47|37.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||37.83|1.47|0.0152
71750088|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1565|TWO_SIDED|95.0|0.73|7.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.30|0.73|0.1565
71750089|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.45||||0.4932|TWO_SIDED|95.0|0.5|4.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.25|0.50|0.4932
71750090|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8504|TWO_SIDED|95.0|0.39|3.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.12|0.39|0.8504
71750091|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0759|TWO_SIDED|95.0|0.89|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.61|0.89|0.0759
71750092|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0477|TWO_SIDED|95.0|1.01|13.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||13.46|1.01|0.0477
71750093|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.47||||0.1448|TWO_SIDED|95.0|0.73|8.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.36|0.73|0.1448
71750094|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|5.54||||0.0173|TWO_SIDED|95.0|1.35|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||22.71|1.35|0.0173
71750095|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1101|TWO_SIDED|95.0|0.81|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.17|0.81|0.1101
71750096|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6022|TWO_SIDED|95.0|0.46|3.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.78|0.46|0.6022
71750097|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6128|TWO_SIDED|95.0|0.46|3.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.73|0.46|0.6128
71750098|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1001|TWO_SIDED|95.0|0.82|9.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.68|0.82|0.1001
71750099|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0255|TWO_SIDED|95.0|1.22|20.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||20.12|1.22|0.0255
71750100|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.42||||0.1521|TWO_SIDED|95.0|0.72|8.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||8.10|0.72|0.1521
71750101|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|9.37||||0.0071|TWO_SIDED|95.0|1.84|47.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||47.69|1.84|0.0071
71750102|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.52||||0.115|TWO_SIDED|95.0|0.8|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.93|0.80|0.1150
71782420|NCT00740831|143064127|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.043|0.14||No p-values generated|ANCOVA|Analysis of covariance after log transformation of the data|As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals|||0.14|-0.043|
71835549|NCT05384730|143176060|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71835550|NCT05384730|143176061|SUPERIORITY|||||||0.13|||||||ANOVA|||||||0.13
71835551|NCT05384730|143176062|SUPERIORITY|||||||0.01|||||||ANOVA|||PASE analysis over time||||0.01
71835552|NCT01772472|143176063|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
71835553|NCT01772472|143176064|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001||95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<0.0001
71835554|NCT01772472|143176065|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.44|0.66|||Log Rank|||||0.66|0.44|<.0001
71835555|NCT01772472|143176066|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
71835556|NCT01772472|143176067|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<0.0001
71750103|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8101|TWO_SIDED|95.0|0.4|3.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.22|0.40|0.8101
71835557|NCT01772472|143176068|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.69|||Log Rank|||||0.69|0.46|<.0001
71835558|NCT01772472|143176069|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
71835559|NCT01772472|143176070|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<0.0001
71835560|NCT01772472|143176071|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.48|0.7|||Log Rank|||||0.70|0.48|<.0001
71835561|NCT01772472|143176072|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
71835562|NCT01772472|143176073|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082||95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
71835563|NCT01772472|143176074|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0082|TWO_SIDED|95.0|0.53|0.91|||Log Rank|||||0.91|0.53|0.0082
71835564|NCT01772472|143176075|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
71835565|NCT01772472|143176076|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001||95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.0001
71835566|NCT01772472|143176077|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<.0001
71835567|NCT04093752|143176130|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% noninferiority (NI) boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common standard deviation (SD) of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.49|||||TWO_SIDED|95.0|-1.69|-1.29||||||||-1.29|-1.69|
71835568|NCT04093752|143176130|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.54|||||TWO_SIDED|95.0|-1.74|-1.34||||||||-1.34|-1.74|
71835569|NCT04093752|143176131|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.4% NI boundary, 0.45% greater mean reduction in tirzepatide doses compared to insulin glargine, 1:1:1:1 randomization, a common SD of 1.2%, one-sided significance level of 0.0125 and a dropout rate of 25%.|LS Mean Difference|-1.29|||||TWO_SIDED|95.0|-1.49|-1.09||||||||-1.09|-1.49|
71835570|NCT04093752|143176132|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-7.4|-5.6|||Mixed Models Analysis|||||-5.6|-7.4|<0.001
71835571|NCT04093752|143176132|SUPERIORITY||LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|95.0|-9.5|-7.6|||Mixed Models Analysis|||||-7.6|-9.5|<0.001
71835572|NCT04093752|143176132|SUPERIORITY||LS Mean Difference|-8.7|||<|0.001|TWO_SIDED|95.0|-9.6|-7.7|||Mixed Models Analysis|||||-7.7|-9.6|<0.001
71835573|NCT04093752|143176133|SUPERIORITY||Odds Ratio (OR)|14.54|||<|0.001|TWO_SIDED|95.0|8.94|23.64|||Regression, Logistic|||||23.64|8.94|<0.001
71835574|NCT04093752|143176133|SUPERIORITY||Odds Ratio (OR)|28.76|||<|0.001|TWO_SIDED|95.0|16.72|49.49|||Regression, Logistic|||||49.49|16.72|<0.001
71835575|NCT04093752|143176133|SUPERIORITY||Odds Ratio (OR)|25.27|||<|0.001|TWO_SIDED|95.0|14.88|42.95|||Regression, Logistic|||||42.95|14.88|<0.001
71835576|NCT04093752|143176134|SUPERIORITY||Odds Ratio (OR)|82.54||||0.002|TWO_SIDED|95.0|5.13|1327.81|||Regression, Logistic|||||1327.81|5.13|0.002
71835577|NCT04093752|143176134|SUPERIORITY||Odds Ratio (OR)|124.76|||<|0.001|TWO_SIDED|95.0|7.79|1997.01|||Regression, Logistic|||||1997.01|7.79|<0.001
71835578|NCT04093752|143176134|SUPERIORITY||Odds Ratio (OR)|184.9|||<|0.001|TWO_SIDED|95.0|11.59|2950.73|||Regression, Logistic|||||2950.73|11.59|<0.001
71835579|NCT04093752|143176135|SUPERIORITY||LS Mean Difference|-12.3|||<|0.001|TWO_SIDED|95.0|-18.3|-6.3|||Mixed Models Analysis|||||-6.3|-18.3|<0.001
71835580|NCT04093752|143176135|SUPERIORITY||LS Mean Difference|-20.0|||<|0.001|TWO_SIDED|95.0|-26.1|-13.9|||Mixed Models Analysis|||||-13.9|-26.1|<0.001
71835581|NCT04093752|143176135|SUPERIORITY||LS Mean Difference|-18.6|||<|0.001|TWO_SIDED|95.0|-24.6|-12.5|||Mixed Models Analysis|||||-12.5|-24.6|<0.001
71835582|NCT04093752|143176136|SUPERIORITY||LS Mean Difference|-34.2|||<|0.001|TWO_SIDED|95.0|-40.1|-28.3|||Mixed Models Analysis|||||-28.3|-40.1|<0.001
71835583|NCT04093752|143176136|SUPERIORITY||LS Mean Difference|-40.6|||<|0.001|TWO_SIDED|95.0|-46.7|-34.6|||Mixed Models Analysis|||||-34.6|-46.7|<0.001
71835584|NCT04093752|143176136|SUPERIORITY||LS Mean Difference|-41.8|||<|0.001|TWO_SIDED|95.0|-47.9|-35.8|||Mixed Models Analysis|||||-35.8|-47.9|<0.001
71835585|NCT04093752|143176137|SUPERIORITY||Odds Ratio (OR)|21.89|||<|0.001|TWO_SIDED|95.0|11.63|41.2|||Regression, Logistic|||||41.20|11.63|<0.001
71835586|NCT04093752|143176137|SUPERIORITY||Odds Ratio (OR)|43.79|||<|0.001|TWO_SIDED|95.0|22.96|83.5|||Regression, Logistic|||||83.50|22.96|<0.001
71835587|NCT04093752|143176137|SUPERIORITY||Odds Ratio (OR)|48.41|||<|0.001|TWO_SIDED|95.0|25.34|92.49|||Regression, Logistic|||||92.49|25.34|<0.001
71835588|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.81|-0.13|||ANCOVA|||Hyperglycemia||-0.13|-0.81|0.007
71750104|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.49||||0.4663|TWO_SIDED|95.0|0.51|4.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.33|0.51|0.4663
71750105|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.8||||0.0453|TWO_SIDED|95.0|1.03|14.01||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.01|1.03|0.0453
71782421|NCT00740831|143064128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
71782422|NCT00740831|143064128|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
71782423|NCT00740831|143064129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.3|||<|0.001|TWO_SIDED|95.0|-40.6|-14.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-14.6|-40.6|<0.001
71782424|NCT00740831|143064129|SUPERIORITY_OR_OTHER||Median Difference (Net)|-29.9|||<|0.001|TWO_SIDED|95.0|-42.0|-16.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata||||-16.6|-42.0|<0.001
71782425|NCT03706079|143064130|SUPERIORITY||Rate Ratio|0.42|||||TWO_SIDED|95.0|0.35|0.51||||||||0.51|0.35|
71782426|NCT03706079|143064130|SUPERIORITY||Rate Ratio|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||||0.96|0.38|
71835589|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.11|-0.43|||ANCOVA|||Hyperglycemia||-0.43|-1.11|<0.001
71835590|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-1.05|-0.36|||ANCOVA|||Hyperglycemia||-0.36|-1.05|<0.001
71750106|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.36||||0.0659|TWO_SIDED|95.0|0.92|12.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.21|0.92|0.0659
71835591|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|-0.14||||0.384|TWO_SIDED|95.0|-0.46|0.18|||ANCOVA|||Hypoglycemia||0.18|-0.46|0.384
71750107|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.83||||0.3117|TWO_SIDED|95.0|0.57|5.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||5.86|0.57|0.3117
71750108|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|6.02||||0.0129|TWO_SIDED|95.0|1.46|24.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.73|1.46|0.0129
71782427|NCT01203098|143064145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.3|||||TWO_SIDED|95.0|-7.2|4.6||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||4.6|-7.2|
71782428|NCT01203098|143064145|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|-4.6|6.8||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.||6.8|-4.6|
71782429|NCT00730405|143064150|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782430|NCT00730405|143064150|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782431|NCT00730405|143064150|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782432|NCT00730405|143064150|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782433|NCT00730405|143064151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782434|NCT00730405|143064151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782435|NCT00730405|143064151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782436|NCT00730405|143064151|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782437|NCT00730405|143064152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782438|NCT00730405|143064152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782439|NCT00730405|143064152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782440|NCT00730405|143064152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782441|NCT00730405|143064153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782442|NCT00730405|143064153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71835592|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|-0.17||||0.307|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Hypoglycemia||0.16|-0.49|0.307
71835593|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|-0.22||||0.184|TWO_SIDED|95.0|-0.55|0.11|||ANCOVA|||Hypoglycemia||0.11|-0.55|0.184
71750109|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0303|TWO_SIDED|95.0|1.14|14.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.83|1.14|0.0303
71750110|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.94||||0.2772|TWO_SIDED|95.0|0.59|6.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.42|0.59|0.2772
71750111|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9432|TWO_SIDED|95.0|0.29|3.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.16|0.29|0.9432
71750112|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.08||||0.2577|TWO_SIDED|95.0|0.59|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.36|0.59|0.2577
71782443|NCT00730405|143064153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782444|NCT00730405|143064153|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782445|NCT00730405|143064154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
71782446|NCT00730405|143064154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.71|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
71782447|NCT00730405|143064154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.44|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|||||||ANOVA|||||||<0.001
71782448|NCT00730405|143064154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.22|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|||||||ANOVA|||||||<0.001
71835594|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|1.81|||<|0.001|TWO_SIDED|95.0|1.03|2.59|||ANCOVA|||Treatment Satisfaction Score||2.59|1.03|<0.001
71835595|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|1.63|||<|0.001|TWO_SIDED|95.0|0.84|2.41|||ANCOVA|||Treatment Satisfaction Score||2.41|0.84|<0.001
71835596|NCT04093752|143176138|SUPERIORITY||LS Mean Difference|1.68|||<|0.001|TWO_SIDED|95.0|0.89|2.47|||ANCOVA|||Treatment Satisfaction Score||2.47|0.89|<0.001
71891615|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.495|-0.041|0.0966
71750113|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1496|TWO_SIDED|95.0|0.71|9.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.12|0.71|0.1496
71782449|NCT00730405|143064155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71835597|NCT01101451|143176140|SUPERIORITY||Hazard Ratio (HR)|0.6976||||0.0927|TWO_SIDED|95.0|0.408|1.192||the pre\_specified nominal significance level was 0.0451 (one sided).|Log Rank||The RFS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.192|0.408|0.0927
71835598|NCT01101451|143176141|SUPERIORITY||Hazard Ratio (HR)|0.586|||||TWO_SIDED|95.0|0.286|1.199|||||The OS hazard ratio estimate is for reporting group 2 vs reporting group 1.|||1.199|0.286|
71782450|NCT00730405|143064155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782451|NCT00730405|143064155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782452|NCT00730405|143064155|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71782453|NCT03851705|143064159|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.9047|TWO_SIDED|95.0|-29.19|25.83||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||25.83|-29.19|0.9047
71782454|NCT03851705|143064160|SUPERIORITY||Mean Difference (Final Values)|6.47||||0.8685|TWO_SIDED|95.0|-70.11|83.05||The a priori threshold for statistical significance was \<0.05 (two-sided)|ANCOVA|||||83.05|-70.11|0.8685
71782455|NCT03851705|143064161|SUPERIORITY||Mean Difference (Final Values)|-12.1||||0.2347|TWO_SIDED|95.0|-32.2|8.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.1|-32.2|0.2347
71782456|NCT03851705|143064161|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.7058|TWO_SIDED|95.0|-19.9|29.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||29.2|-19.9|0.7058
71782457|NCT03851705|143064161|SUPERIORITY||Mean Difference (Final Values)|-5.7||||0.5653|TWO_SIDED|95.0|-25.5|14.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||14.1|-25.5|0.5653
71782458|NCT03851705|143064163|SUPERIORITY||Mean Difference (Final Values)|-19.9||||0.4589|TWO_SIDED|95.0|-73.3|33.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.6|-73.3|0.4589
71782459|NCT03851705|143064163|SUPERIORITY||Mean Difference (Final Values)|17.7||||0.5956|TWO_SIDED|95.0|-48.8|84.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||84.3|-48.8|0.5956
71782460|NCT03851705|143064163|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.7861|TWO_SIDED|95.0|-62.7|47.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||47.7|-62.7|0.7861
71782461|NCT03851705|143064165|SUPERIORITY||Mean Difference (Final Values)|-62.6|||<|0.0001|TWO_SIDED|95.0|-80.1|-45.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-45.1|-80.1|<.0001
71835599|NCT04757610|143176152|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.023||0.284421|TWO_SIDED|95.0|-3.1|0.91|||MMRM|||||0.91|-3.10|0.284421
71835600|NCT04757610|143176152|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.025||0.066678|TWO_SIDED|95.0|-3.9|0.13|||MMRM|||||0.13|-3.90|0.066678
71750114|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.05||||0.2874|TWO_SIDED|95.0|0.55|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.55|0.2874
71750115|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1981|TWO_SIDED|95.0|0.65|7.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.78|0.65|0.1981
71750116|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0531|TWO_SIDED|95.0|0.98|11.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.43|0.98|0.0531
71782462|NCT03851705|143064165|SUPERIORITY||Mean Difference (Final Values)|-60.6|||<|0.0001|TWO_SIDED|95.0|-83.5|-37.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-37.8|-83.5|<.0001
71782463|NCT03851705|143064165|SUPERIORITY||Mean Difference (Final Values)|-92.3|||<|0.0001|TWO_SIDED|95.0|-120.4|-64.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-64.2|-120.4|<.0001
71782464|NCT03851705|143064167|SUPERIORITY||Mean Difference (Final Values)|-316.6|||<|0.0001|TWO_SIDED|95.0|-420.7|-212.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||-212.6|-420.7|<.0001
71782465|NCT03851705|143064167|SUPERIORITY||Mean Difference (Final Values)|-304.4|||<|0.0001|TWO_SIDED|95.0|-408.0|-200.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||-200.8|-408.0|<.0001
71782466|NCT03851705|143064167|SUPERIORITY||Mean Difference (Final Values)|-390.4|||<|0.0001|TWO_SIDED|95.0|-504.5|-276.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||-276.3|-504.5|<.0001
71782467|NCT03851705|143064169|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.3299|TWO_SIDED|95.0|-23.9|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.2|-23.9|0.3299
71782468|NCT03851705|143064169|SUPERIORITY||Mean Difference (Final Values)|2.7||||0.7778|TWO_SIDED|95.0|-16.7|22.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||22.2|-16.7|0.7778
71835601|NCT04154384|143176171|SUPERIORITY|A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 3 months follow-up.||||||0.035||||||A comparison of the proportion of participants in each arm reporting an improvement in average pain score on the Numeric Rating Scale from baseline to 12 weeks follow-up.|Chi-squared|||||||0.035
71750117|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.72||||0.5858|TWO_SIDED|95.0|0.22|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.35|0.22|0.5858
71750118|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.68||||0.5122|TWO_SIDED|95.0|0.21|2.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.16|0.21|0.5122
71782469|NCT03851705|143064169|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.6613|TWO_SIDED|95.0|-19.2|12.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||12.3|-19.2|0.6613
71782470|NCT03851705|143064170|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.4911|TWO_SIDED|95.0|-74.0|36.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||36.0|-74.0|0.4911
71782471|NCT03851705|143064170|SUPERIORITY||Mean Difference (Final Values)|11.1||||0.7461|TWO_SIDED|95.0|-57.2|79.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||79.4|-57.2|0.7461
71782472|NCT03851705|143064170|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.837|TWO_SIDED|95.0|-62.8|51.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||51.1|-62.8|0.8370
71782473|NCT03851705|143064173|SUPERIORITY||Mean Difference (Final Values)|-12.7||||0.1371|TWO_SIDED|95.0|-29.5|4.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.2|-29.5|0.1371
71782474|NCT03851705|143064173|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.71|TWO_SIDED|95.0|-22.6|15.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||15.5|-22.6|0.7100
71782475|NCT03851705|143064173|SUPERIORITY||Mean Difference (Final Values)|-10.3||||0.2278|TWO_SIDED|95.0|-27.2|6.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||6.6|-27.2|0.2278
71782476|NCT03851705|143064175|SUPERIORITY||Mean Difference (Final Values)|-19.4||||0.2044|TWO_SIDED|95.0|-49.7|10.9||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||10.9|-49.7|0.2044
71782477|NCT03851705|143064175|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.7875|TWO_SIDED|95.0|-39.9|30.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||30.4|-39.9|0.7875
71782478|NCT03851705|143064175|SUPERIORITY||Mean Difference (Final Values)|-15.8||||0.3193|TWO_SIDED|95.0|-47.3|15.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||15.7|-47.3|0.3193
71782479|NCT03851705|143064177|SUPERIORITY||Mean Difference (Final Values)|-10.1||||0.2877|TWO_SIDED|95.0|-29.0|8.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||8.8|-29.0|0.2877
71782480|NCT03851705|143064177|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.7944|TWO_SIDED|95.0|-19.7|25.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||25.7|-19.7|0.7944
71782481|NCT03851705|143064177|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.5803|TWO_SIDED|95.0|-23.4|13.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.3|-23.4|0.5803
71750119|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.55||||0.3415|TWO_SIDED|95.0|0.16|1.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.89|0.16|0.3415
71750120|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.87||||0.8263|TWO_SIDED|95.0|0.25|2.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.98|0.25|0.8263
71750121|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.86||||0.8085|TWO_SIDED|95.0|0.24|3.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.03|0.24|0.8085
71750122|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.3||||0.6745|TWO_SIDED|95.0|0.38|4.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.43|0.38|0.6745
71750123|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9019|TWO_SIDED|95.0|0.34|3.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.45|0.34|0.9019
71750124|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.62||||0.4425|TWO_SIDED|95.0|0.18|2.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.10|0.18|0.4425
71750125|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.54||||0.3106|TWO_SIDED|95.0|0.17|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.17|0.3106
71750126|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.32||||0.0912|TWO_SIDED|95.0|0.08|1.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.20|0.08|0.0912
71782482|NCT03851705|143064179|SUPERIORITY||Mean Difference (Final Values)|-19.1||||0.4848|TWO_SIDED|95.0|-73.6|35.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||35.3|-73.6|0.4848
71835602|NCT05048186|143176183|OTHER||Mean Difference (Final Values)|0.06||||0.503|TWO_SIDED|95.0|-0.116|0.236|||t-test, 2 sided|||we tested to see whether SDM Process scores were different between patients who received the Decision Aid Arm vs the control arm||0.236|-0.116|0.503
71750127|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.7||||0.5681|TWO_SIDED|95.0|0.2|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.20|0.5681
71750128|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.58||||0.4261|TWO_SIDED|95.0|0.15|2.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.21|0.15|0.4261
71750129|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7514|TWO_SIDED|95.0|0.24|2.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.82|0.24|0.7514
71782483|NCT03851705|143064179|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.722|TWO_SIDED|95.0|-56.0|80.3||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||80.3|-56.0|0.7220
71835603|NCT04218266|143176205|OTHER||Crude incidence ratio|0.42|||||TWO_SIDED|90.0|0.26|0.67||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in all bleeding||0.67|0.26|
71835604|NCT04218266|143176207|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH CRNM bleeding||0.97|0.09|
71835605|NCT04218266|143176208|OTHER||Crude incidence ratio|0.47|||||TWO_SIDED|90.0|0.28|0.83||||||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH minor bleeding||0.83|0.28|
71835606|NCT04218266|143176209|OTHER||Crude incidence ratio|0.33|||||TWO_SIDED|90.0|0.09|0.97|||Other|||Comparison of the Asundexian pooled group (Asundexian 20 mg group and Asundexian 50 mg group) versus Apixaban group in ISTH major bleeding or CRNM bleeding||0.97|0.09|
71782484|NCT03851705|143064179|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.8036|TWO_SIDED|95.0|-63.6|49.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||49.5|-63.6|0.8036
71782485|NCT03851705|143064187|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6028|TWO_SIDED|95.0|-6.8|11.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||11.7|-6.8|0.6028
71835607|NCT02742519|143176211|SUPERIORITY|||||||0.2121|||||||t-test, 2 sided|||||||0.2121
71750130|NCT03192176|143005311|SUPERIORITY||Odds Ratio (OR)|0.52||||0.2712|TWO_SIDED|95.0|0.16|1.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.67|0.16|0.2712
71750131|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0103|TWO_SIDED|95.0|1.46|16.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.40|1.46|0.0103
71782486|NCT03851705|143064187|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.8428|TWO_SIDED|95.0|-11.5|14.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||14.0|-11.5|0.8428
71782487|NCT03851705|143064187|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.4946|TWO_SIDED|95.0|-6.6|13.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||13.4|-6.6|0.4946
71782488|NCT03851705|143064189|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.9237|TWO_SIDED|95.0|-4.0|4.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.4|-4.0|0.9237
71782489|NCT03851705|143064189|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7177|TWO_SIDED|95.0|-6.5|4.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||4.5|-6.5|0.7177
71782490|NCT03851705|143064189|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.5416|TWO_SIDED|95.0|-2.9|5.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.4|-2.9|0.5416
71782491|NCT03851705|143064191|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6497|TWO_SIDED|95.0|-3.2|5.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||5.2|-3.2|0.6497
71782492|NCT03851705|143064191|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.3209|TWO_SIDED|95.0|-7.9|2.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||2.6|-7.9|0.3209
71782493|NCT03851705|143064191|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9294|TWO_SIDED|95.0|-6.3|5.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.7|-6.3|0.9294
71750132|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0011|TWO_SIDED|95.0|2.2|23.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.48|2.20|0.0011
71782494|NCT03851705|143064193|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.3105|TWO_SIDED|95.0|-10.8|33.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||33.4|-10.8|0.3105
71782495|NCT03851705|143064193|SUPERIORITY||Mean Difference (Final Values)|-11.4||||0.3018|TWO_SIDED|95.0|-33.3|10.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||10.5|-33.3|0.3018
71782496|NCT03851705|143064193|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8755|TWO_SIDED|95.0|-27.0|31.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||31.6|-27.0|0.8755
71782497|NCT03851705|143064195|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6848|TWO_SIDED|95.0|-11.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||7.6|-11.5|0.6848
71782498|NCT03851705|143064195|SUPERIORITY||Mean Difference (Final Values)|-5.4||||0.4075|TWO_SIDED|95.0|-18.5|7.6||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.6|-18.5|0.4075
71782499|NCT03851705|143064195|SUPERIORITY||Mean Difference (Final Values)|-2.8||||0.5998|TWO_SIDED|95.0|-13.4|7.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||7.8|-13.4|0.5998
71782500|NCT03851705|143064197|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.7958|TWO_SIDED|95.0|-8.4|6.5||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||6.5|-8.4|0.7958
71782501|NCT03851705|143064197|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.6003|TWO_SIDED|95.0|-12.7|7.4||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||7.4|-12.7|0.6003
71782502|NCT03851705|143064197|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5352|TWO_SIDED|95.0|-11.0|5.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||5.8|-11.0|0.5352
71782503|NCT03851705|143064199|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.1716|TWO_SIDED|95.0|-21.8|4.0||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||4.0|-21.8|0.1716
71782504|NCT03851705|143064199|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.1671|TWO_SIDED|95.0|-46.2|8.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||8.2|-46.2|0.1671
71782505|NCT03851705|143064199|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.1808|TWO_SIDED|95.0|-24.2|4.7||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||4.7|-24.2|0.1808
71782506|NCT03851705|143064201|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.3077|TWO_SIDED|95.0|-28.3|9.1||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 90||9.1|-28.3|0.3077
71782507|NCT03851705|143064201|SUPERIORITY||Mean Difference (Final Values)|-9.4||||0.3628|TWO_SIDED|95.0|-30.1|11.2||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 150||11.2|-30.1|0.3628
71750133|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|11.06|||<|0.0001|TWO_SIDED|95.0|3.41|35.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||35.86|3.41|<0.0001
71835608|NCT02728557|143176263|OTHER|MLM models||||||0.016|||||||MLM|MLM||A model with two three-way interactions of time by treatment condition by attachment orientation (Time Å\~ Treatment condition Å\~ Attachment anxiety, Time Å\~ Treatment condition Å\~ Attachment avoidance) along the lower-level effects to predict differences in the slope of change in outcome. The threshold for statistical significance was p\>0.05.||||.016
71835609|NCT04052516|143176269|OTHER|Cochran-Mantel-Haenszal test|Odds Ratio (OR)|1.7||||0.2991|TWO_SIDED|95.0|0.62|4.63|||Cochran-Mantel-Haenszel|||||4.63|0.62|0.2991
71835610|NCT04052516|143176269|OTHER|Cochran-Mantel-Haenszel Test|Odds Ratio (OR)|2.01||||0.1386|TWO_SIDED|95.0|0.8|5.08|||Cochran-Mantel-Haenszel|||||5.08|0.80|0.1386
71835611|NCT03416010|143176282|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no significant difference in Health Beliefs across those 4 time points.||||<0.001
71891616|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.492|-0.045|0.1029
71891617|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.478|-0.056|0.1220
71750134|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|10.48||||0.0001|TWO_SIDED|95.0|3.18|34.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||34.55|3.18|0.0001
71750135|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.46||||0.1571|TWO_SIDED|95.0|0.71|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.55|0.71|0.1571
71750136|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|7.14||||0.001|TWO_SIDED|95.0|2.21|23.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.04|2.21|0.0010
71750137|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|7.35||||0.0008|TWO_SIDED|95.0|2.29|23.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||23.61|2.29|0.0008
71835612|NCT03416010|143176282|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the full intervention group, COPE-P, and the attention-control group, Preg+, in Health Beliefs, as measured by the Healthy Lifestyle Beliefs measure, at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth||||<0.001
71835613|NCT03416010|143176282|OTHER|||||||0.009|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||0.009
71677080|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.1||||0.0752|TWO_SIDED|95.0|-8.58|0.42||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||0.42|-8.58|0.0752
71750138|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0342|TWO_SIDED|95.0|1.08|7.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.18|1.08|0.0342
71891618|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.707|0.170|0.0014
71891619|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.465|-0.074|0.1542
71750139|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0231|TWO_SIDED|95.0|1.16|7.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.66|1.16|0.0231
71750140|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.12||||0.0032|TWO_SIDED|95.0|1.6|10.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.55|1.60|0.0032
71750141|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.89||||0.0059|TWO_SIDED|95.0|1.48|10.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.22|1.48|0.0059
71750142|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.76||||0.2471|TWO_SIDED|95.0|0.68|4.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.59|0.68|0.2471
71750143|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0381|TWO_SIDED|95.0|1.05|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.70|1.05|0.0381
71750144|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0113|TWO_SIDED|95.0|1.31|8.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.48|1.31|0.0113
71750145|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.56||||0.0486|TWO_SIDED|95.0|1.01|6.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.52|1.01|0.0486
71750146|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.71||||0.035|TWO_SIDED|95.0|1.07|6.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.87|1.07|0.0350
71750147|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0027|TWO_SIDED|95.0|1.65|10.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.90|1.65|0.0027
71750148|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.68||||0.002|TWO_SIDED|95.0|1.76|12.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||12.47|1.76|0.0020
71750149|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0686|TWO_SIDED|95.0|0.94|6.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.19|0.94|0.0686
71750150|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0034|TWO_SIDED|95.0|1.58|10.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.21|1.58|0.0034
71750151|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0222|TWO_SIDED|95.0|1.16|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.22|1.16|0.0222
71782508|NCT03851705|143064201|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.4669|TWO_SIDED|95.0|-23.2|10.8||The a priori threshold for statistical significance was \<0.05 (two-sided)|Mixed Model Repeated Measures|||Day 180||10.8|-23.2|0.4669
71782509|NCT03851705|143064207|SUPERIORITY||Mean Difference (Final Values)|-4.31||||0.6814|TWO_SIDED|95.0|-24.88|16.27|||ANCOVA|||||16.27|-24.88|0.6814
71782510|NCT03851705|143064208|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.8725|TWO_SIDED|95.0|-27.7|23.51|||ANCOVA|||||23.51|-27.70|0.8725
71782511|NCT03851705|143064209|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.9425|TWO_SIDED|95.0|-22.3|20.72|||ANCOVA|||||20.72|-22.30|0.9425
71782512|NCT03851705|143064210|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.2|5.2|||Regression, Logistic|||||5.2|0.2|
71782513|NCT00959764|143064218|NON_INFERIORITY_OR_EQUIVALENCE|"Assumed placebo-adjusted effect for both active treatment groups (% increase in BMD)was 1.56% and that the placebo adjusted effect for the rsCT tablets must be at least 0.5 times the placebo adjusted effect for the calcitonin nasal spray (active control treatment group). The null hypothesis to be tested was:~\[Mean(oral) - Mean(placebo)\] - 0.5 x \[Mean(nasal) - Mean(placebo)\] \< 0. Reference Pigeot, et al. 2003"|Mean Difference (Net)|0.77|STANDARD_DEVIATION|2.5||0.002|TWO_SIDED|95.0|0.08|1.45||The P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05|ANCOVA|||The overall analysis across groups was an Analysis of Covariance where the study was powered to 80% with an assumption of a standard deviation of 2.5% and a two-sided 5% level of significance. For each treatment group, the BMD at 48 weeks was compared with the BMD at baseline and a % increase was calculated (baseline = 0%). This difference was subjected to the t-test. Two-sided P-value is less than or equal to 0.05 and was not adjusted as multiple comparisons were not done.||1.45|0.08|0.002
71782514|NCT00959764|143064219|NON_INFERIORITY_OR_EQUIVALENCE|Same as for Primary Outcome|Mean Difference (Net)|-21.84|STANDARD_DEVIATION|41.99||0.0006||||||P-value not adjusted for multiple comparisons; a priori threshold for significance was 0.05|ANCOVA|95% confidence interval not calculated||Same as for Primary Outcome||||0.0006
71782515|NCT00959764|143064220|NON_INFERIORITY_OR_EQUIVALENCE|Same as Primary Outcome|Mean Difference (Net)|-18.09|STANDARD_DEVIATION|47.53||0.0012||||||p-value not adjusted for multiple comparisons; a priori threshold for statistical significance was set at 0.05.|ANCOVA||oral calcitonin vs placebo|Same as Primary Outcome||||0.0012
71782516|NCT00692341|143064221|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|88.61|||||TWO_SIDED|90.0|49.2|159.56||||||For mild hepatic impairment, analysis of variance (ANOVA) was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and confidence intervals (CIs) on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||159.56|49.20|
71782517|NCT00692341|143064221|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|127.67|||||TWO_SIDED|90.0|70.9|229.91||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.91|70.90|
71782518|NCT00692341|143064222|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.34|||||TWO_SIDED|90.0|39.92|153.75||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||153.75|39.92|
71782519|NCT00692341|143064222|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|195.25|||||TWO_SIDED|90.0|99.49|383.18||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||383.18|99.49|
71782520|NCT00692341|143064223|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|78.14|||||TWO_SIDED|90.0|38.68|157.82||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||157.82|38.68|
71782521|NCT00692341|143064223|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|198.9|||||TWO_SIDED|90.0|98.47|401.74||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||401.74|98.47|
71835614|NCT03416010|143176283|OTHER||||||<|0.001||||||Threshold for significance: p \<0.01|two-way ANOVA|||Null hypothesis: there was no significant difference in anxiety across the 4 time points.||||<0.001
71835615|NCT03416010|143176283|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in anxiety at T0 baseline, as well as at timepoint 1(immediately following the intervention), timepoint 2 (6 weeks after the infants' birth), and timepoint 3 (6 months after the infants' birth).||||<0.001
71835616|NCT03416010|143176283|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
71835617|NCT03416010|143176284|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in health behaviors across those 4 time points.||||<0.001
71835618|NCT03416010|143176284|OTHER||||||<|0.001|||||||two-way ANOVA|||||||<0.001
71835619|NCT03416010|143176284|OTHER||||||<|0.001|||||||two-way ANOVA|||Null Hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
71835620|NCT03416010|143176285|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in depressive symptoms across those 4 timepoints.||||<0.001
71835621|NCT03416010|143176285|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in depressive symptoms at T0 baseline, as well as at time points 1, immediately following the intervention, 2, 6 weeks after the infants' birth, and 3, 6 months after the infants' birth.||||<0.001
71835622|NCT03416010|143176285|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
71891620|NCT01431287|143304576|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.461|-0.077|0.1626
71782522|NCT00692341|143064228|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|73.78|||||TWO_SIDED|90.0|37.4|145.56||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||145.56|37.40|
71891621|NCT01431287|143304576|SUPERIORITY_OR_OTHER||djusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.274|-0.265|0.9765
71891622|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.925|0.370|<0.0001
71891623|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.600|0.045|0.0226
71891624|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.649|0.093|0.0089
71891625|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.609|0.056|0.0186
71782523|NCT00692341|143064228|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.86|||||TWO_SIDED|90.0|55.58|183.02||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||183.02|55.58|
71835623|NCT03416010|143176286|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference in stress across those 4 time points.||||<0.001
71891626|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.324|-0.231|0.7441
71891627|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.551|0.001|0.0492
71835624|NCT03416010|143176286|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no significant difference between the two groups in stress, as measured by the GAD-7, at T0 baseline, as well as at timepoint 1 (immediately following the intervention), timepoint 2 (6 weeks after the infants' birth) and timepoint 3 (6 months after the infants' birth).||||<0.001
71835625|NCT03416010|143176286|OTHER||||||<|0.001|||||||two-way ANOVA|||Null hypothesis: There was no statistically significant interaction between the intervention group and time.||||<0.001
71835626|NCT04505774|143176358|SUPERIORITY|||||||0.6778|||||||t-test, 2 sided|||||||.6778
71835627|NCT04505774|143176358|SUPERIORITY|||||||0.6292|||||||t-test, 2 sided|||||||.6292
71835628|NCT04505774|143176358|SUPERIORITY|||||||0.6858|||||||t-test, 2 sided|||||||.6858
71835629|NCT04505774|143176358|SUPERIORITY|||||||0.1351|||||||t-test, 2 sided|||||||.1351
71835630|NCT04505774|143176359|SUPERIORITY|||||||0.1959|||||||Chi-squared|||||||.1959
71835631|NCT04505774|143176359|SUPERIORITY|||||||0.9496|||||||Chi-squared|||||||0.9496
71835632|NCT04505774|143176359|SUPERIORITY|||||||0.9902|||||||Chi-squared|||||||.9902
71782524|NCT00692341|143064229|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.43|||||TWO_SIDED|90.0|44.75|186.79||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||186.79|44.75|
71782525|NCT00692341|143064229|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|50.78|||||TWO_SIDED|90.0|27.14|95.03||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||95.03|27.14|
71835633|NCT04505774|143176359|SUPERIORITY|||||||0.0814|||||||Chi-squared|||||||.0814
71835634|NCT04505774|143176360|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71835635|NCT04505774|143176360|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71835636|NCT04505774|143176360|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71835637|NCT04505774|143176361|SUPERIORITY|||||||0.0577|||||||Chi-squared|||||||.0577
71891628|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.884|0.332|<0.0001
71891629|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.605|0.045|0.0230
71782526|NCT00692341|143064230|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.09|||||TWO_SIDED|90.0|51.53|206.22||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||206.22|51.53|
71835638|NCT04505774|143176361|SUPERIORITY|||||||0.5015|||||||Chi-squared|||||||.5015
71835639|NCT04505774|143176361|SUPERIORITY|||||||0.5892|||||||Chi-squared|||||||.5892
71835640|NCT04505774|143176361|SUPERIORITY|||||||0.1714|||||||Chi-squared|||||||.1714
71835641|NCT04505774|143176362|SUPERIORITY|||||||0.0732|||||||Chi-squared|||||||.0732
71835642|NCT04505774|143176362|SUPERIORITY|||||||0.9018|||||||Chi-squared|||||||.9018
71835643|NCT04505774|143176362|SUPERIORITY|||||||0.5075|||||||Chi-squared|||||||.5075
71835644|NCT04505774|143176362|SUPERIORITY|||||||0.145|||||||Chi-squared|||||||.1450
71835645|NCT04505774|143176363|SUPERIORITY|||||||0.8837|||||||Chi-squared|||||||.8837
71835646|NCT04505774|143176363|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71835647|NCT04505774|143176363|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71835648|NCT04505774|143176363|SUPERIORITY|||||||0.5343|||||||Chi-squared|||||||.5343
71835649|NCT04505774|143176364|SUPERIORITY|||||||0.6636|||||||t-test, 2 sided|||||||.6636
71835650|NCT04505774|143176364|SUPERIORITY|||||||0.5878|||||||t-test, 2 sided|||||||.5878
71835651|NCT04505774|143176364|SUPERIORITY|||||||0.7148|||||||t-test, 2 sided|||||||.7148
71835652|NCT04505774|143176364|SUPERIORITY|||||||0.1117|||||||t-test, 2 sided|||||||.1117
71835653|NCT04505774|143176365|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||.6780
71835654|NCT04505774|143176365|SUPERIORITY|||||||0.6638|||||||t-test, 2 sided|||||||.6638
71835655|NCT04505774|143176365|SUPERIORITY|||||||0.7645|||||||t-test, 2 sided|||||||.7645
71835656|NCT04505774|143176365|SUPERIORITY|||||||0.0987|||||||t-test, 2 sided|||||||0.0987
71835657|NCT04505774|143176366|SUPERIORITY|||||||0.4016|||||||t-test, 2 sided|||||||.4016
71835658|NCT04505774|143176366|SUPERIORITY|||||||0.5815|||||||t-test, 2 sided|||||||.5815
71835659|NCT04505774|143176366|SUPERIORITY|||||||0.9085|||||||t-test, 2 sided|||||||.9085
71835660|NCT04505774|143176366|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||.0820
71835661|NCT04505774|143176367|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||.3135
71835662|NCT04505774|143176367|SUPERIORITY|||||||0.9581|||||||Chi-squared|||||||.9581
71835663|NCT04505774|143176367|SUPERIORITY|||||||0.9661|||||||Chi-squared|||||||.9661
71835664|NCT04505774|143176367|SUPERIORITY|||||||0.1073|||||||Chi-squared|||||||.1073
71835665|NCT04505774|143176368|SUPERIORITY|||||||0.3575|||||||Chi-squared|||||||.3575
71835666|NCT04505774|143176368|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||.5910
71835667|NCT04505774|143176368|SUPERIORITY|||||||0.867|||||||Chi-squared|||||||.8670
71835668|NCT04505774|143176368|SUPERIORITY|||||||0.0645|||||||Chi-squared|||||||.0645
71835669|NCT04788537|143176369|SUPERIORITY|Linear mixed model regression|Slope|-1.58||||0.006|TWO_SIDED||||||Mixed Models Analysis||Slope reported is for Time x Group Interaction|||||.006
71835670|NCT05141903|143176375|SUPERIORITY||||||<|0.0001||||||(Dose group \* Time)|Mixed Models Analysis|Dfn, Dfd = 11, 369 F Value = 24.31||Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
71835671|NCT05141903|143176375|SUPERIORITY||||||<|0.0001||||||Dose group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 370 F value = 14.87||Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over time||||<0.0001
71835672|NCT05141903|143176375|SUPERIORITY||||||<|0.0001||||||Dose Group \* Time|Mixed Models Analysis|Dfn, Dfd = 11, 351 F value = 8.606||Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over time||||<0.0001
71835673|NCT04640961|143176441|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71835674|NCT04640961|143176442|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71782527|NCT00692341|143064230|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|76.06|||||TWO_SIDED|90.0|41.41|139.73||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||139.73|41.41|
71891630|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.317|-0.240|0.7855
71782528|NCT00692341|143064231|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|109.38|||||TWO_SIDED|90.0|53.54|223.47||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||223.47|53.54|
71782529|NCT00692341|143064231|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|196.92|||||TWO_SIDED|90.0|105.23|368.49||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||368.49|105.23|
71891631|NCT01431287|143304577|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.|||0.564|0.007|0.0442
71782530|NCT00692341|143064232|SUPERIORITY_OR_OTHER||Adjusted ratio of geometric means|111.65|||||TWO_SIDED|90.0|54.35|229.37||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||229.37|54.35|
71782531|NCT00692341|143064232|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|200.6|||||TWO_SIDED|90.0|106.68|377.2||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||377.20|106.68|
71782532|NCT00692341|143064233|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.82|||||TWO_SIDED|90.0|58.22|195.99||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||195.99|58.22|
71782533|NCT00692341|143064233|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|128.76|||||TWO_SIDED|90.0|75.62|219.25||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.||219.25|75.62|
71891632|NCT00110305|143304580|SUPERIORITY_OR_OTHER||Differences in response rate|0.5||||0.92|TWO_SIDED|95.0|-10.4|11.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||11.3|-10.4|0.92
71782534|NCT02002091|143064240|OTHER|||||||0.706|||||||Chi-squared|||||||0.706
71668534|NCT05724589|142853466|SUPERIORITY|Repeated measures ANOVA was used to detect any change in facial melanin levels due to the intervention.|Mean Difference (Final Values)|-3.458||||1|TWO_SIDED|||||The p-value indicates no statistically significant change in facial melanin index over time. The p-value was not adjusted for multiple comparisons. Statistical significance was pre-specified at p \< 0.05.|ANOVA|Sphericity assumptions were checked and addressed as needed (e.g., Greenhouse-Geisser correction).|The estimation parameter reflects the mean change in melanin index from baseline to week 16. Baseline was used as the reference point in the analysis.|The statistical analysis assessed changes in facial melanin index after serum application using repeated measures ANOVA. This method evaluated differences across multiple time points (Baseline, Week 8, Week 12, and Week 16) within the same participants, accounting for the correlated nature of repeated measures.||||1.000
71668535|NCT05724589|142853467|SUPERIORITY|A descriptive analysis was performed. No hypothesis testing or power calculation was conducted for this outcome.|percentage of participants at week 16|44.0||||1|TWO_SIDED|||||The p-value reflects descriptive analysis of SGAIS improvement scores; no statistical testing for significance was conducted.|Descriptive|The evaluation involved categorical SGAIS ratings assigned by two independent dermatologists.|This estimate reflects the proportion of participants rated as showing mild improvement on the SGAIS at Week 16, as detailed in the tabular data.|Improvement in facial appearance was assessed using the Subject Global Aesthetic Improvement Scale (SGAIS), rated independently by two board-certified dermatologists at multiple time points (8, 12, and 16 weeks).||||1.000
71668536|NCT05724589|142853468|SUPERIORITY|Descriptive summary statistics were used to report satisfaction at multiple time points. No inferential testing was performed.|percentage of participants at week 16|75.0|||||TWO_SIDED||||||Descriptive|No formal statistical hypothesis testing was performed.|The estimated percentage reflects participants who reported a satisfaction score of 2 or 3 at week 16.|"Satisfaction was assessed at weeks 8, 12, and 16 using a quartile scale:~0 = Unsatisfied, 1 = Slightly satisfied, 2 = Satisfied, 3 = Very satisfied. One participant was lost to follow-up after week 12."||||
71668537|NCT05724589|142853469|SUPERIORITY|This was a descriptive safety analysis. No inferential hypothesis testing was conducted.|Percentage adverse events by week 16|0.0|||||TWO_SIDED||||||Descriptive|No formal statistical test was conducted.|Descriptive summaries of adverse event incidence are reported in the results tables.|The analysis population includes 28 participants. One subject was lost to follow-up at week 12. Adverse events were assessed through video calls at weeks 2 and 4, and in-person visits at 2, 3, and 4 months.||||
71668538|NCT02329015|142853470|SUPERIORITY_OR_OTHER||Slope|0.58||||0.54|TWO_SIDED|95.0|-1.25|2.41|||Regression, Logistic|||Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.||2.41|-1.25|0.54
71668539|NCT02329015|142853470|SUPERIORITY_OR_OTHER||Slope|1.67||||0.08|TWO_SIDED|95.0|-0.21|3.55|||Regression, Linear|||Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.||3.55|-0.21|0.08
71782535|NCT02002091|143064241|OTHER|||||||0.346|||||||Chi-squared|||||||0.346
71782536|NCT02002091|143064242|OTHER|||||||0.123|||||||Mantel Haenszel|||||||0.123
71782537|NCT02002091|143064243|OTHER|||||||0.968|||||||Chi-squared, Corrected|||||||0.968
71782538|NCT02002091|143064244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||The threshold for statistical significance for P-Value is \<0.05|Fisher Exact|||||||0.004
71782539|NCT02002091|143064245|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|||||||Fisher Exact|||||||0.988
71782540|NCT02002091|143064246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||Fisher Exact|||||||0.038
71835675|NCT04640961|143176443|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71782541|NCT02002091|143064248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.917|||||||Chi-squared, Corrected|||||||0.917
71782542|NCT02002091|143064249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.816|||||||Chi-squared, Corrected|||||||0.816
71782543|NCT02002091|143064250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Statistical significance : p\< 0.05|Fisher Exact|||||||0.008
71782544|NCT02002091|143064252|OTHER|||||||0.025||||||The threshold of statistical difference is P-value \< 0.05|Chi-squared, Corrected|||||||0.025
71782545|NCT02002091|143064255|OTHER|||||||0.059||||||the threshold for statistical significance used is P-value \<0.05|Fisher Exact|||||||0.059
71782546|NCT03385564|143064286|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-5.68||||0.7957|TWO_SIDED|80.0|-34.192|22.825|||Regression, Logistic||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||22.825|-34.192|0.7957
71782547|NCT03385564|143064286|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|-9.37||||0.5811|TWO_SIDED|80.0|-31.178|12.44|||Regression, Logistic||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||12.440|-31.178|0.5811
71782548|NCT03385564|143064286|OTHER|Percentage of patients with CRR at Week 52 without renal flare were analysed using a logistic regression model. Factors in the model included treatment and the covariates: race (Asian versus (vs.) non-Asian) and proteinuria \<3 gram (g)/day vs. ≥3 g/day (or Urine protein (UP)/ Urine creatinine (UC) \<3 vs. UP/UC ≥3) at screening.|Difference|1.97||||0.8972|TWO_SIDED|80.0|-17.534|21.48|||Regression, Logistic||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the delta method.|||21.480|-17.534|0.8972
71845303|NCT01787032|143204591|SUPERIORITY_OR_OTHER||Ratio|213.39|STANDARD_DEVIATION|34.1|||TWO_SIDED|90.0|175.783|259.051|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||259.051|175.783|
71835676|NCT03052608|143176446|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.191|0.413||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ethnicity and brain metastases) was significant at the 0.0081 level at the cutoff date of this report.|one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|The study was designed to test the null hypothesis H0: λ ≥1 versus the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR; Lorlatinib/Crizotinib). Evaluation of 177 PFS events was required to have at least 90% power to detect a HR of 0.611 using a one-sided stratified log-rank test at a significance level of 0.025 (one-sided), and a 2-look group-sequential design with a Lan-DeMets (O'Brien-Fleming) α-spending function to determine the efficacy boundaries.||0.413|0.191|<0.0001
71750152|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0876|TWO_SIDED|95.0|0.89|5.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.84|0.89|0.0876
71750153|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.72||||0.0345|TWO_SIDED|95.0|1.08|6.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.88|1.08|0.0345
71750154|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0319|TWO_SIDED|95.0|1.09|6.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.99|1.09|0.0319
71750155|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.27||||0.0013|TWO_SIDED|95.0|1.92|14.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.47|1.92|0.0013
71750156|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.91||||0.1751|TWO_SIDED|95.0|0.75|4.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.87|0.75|0.1751
71750157|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.73|11.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||11.50|1.73|0.0019
71750158|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0284|TWO_SIDED|95.0|1.11|6.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.97|1.11|0.0284
71750159|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.72||||0.265|TWO_SIDED|95.0|0.66|4.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.45|0.66|0.2650
71750160|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1238|TWO_SIDED|95.0|0.82|5.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.38|0.82|0.1238
71750161|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0219|TWO_SIDED|95.0|1.18|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.74|1.18|0.0219
71750162|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.46||||0.0022|TWO_SIDED|95.0|1.84|16.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.16|1.84|0.0022
71750163|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.82||||0.223|TWO_SIDED|95.0|0.69|4.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.77|0.69|0.2230
71750164|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||13.97|1.83|0.0018
71668540|NCT02329015|142853470|SUPERIORITY_OR_OTHER||Slope|2.7||||0.009|TWO_SIDED|95.0|0.69|4.71|||Regression, Linear|||Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.||4.71|0.69|0.009
71750165|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0205|TWO_SIDED|95.0|1.19|8.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.42|1.19|0.0205
71668541|NCT02329015|142853471|SUPERIORITY_OR_OTHER|||||||0.301|||||||Regression, Linear|||Analysis of the Voluntary subscale of the Response to Stress Questionnaire||||0.301
71891633|NCT00110305|143304580|SUPERIORITY_OR_OTHER||Difference in response rate|-2.3||||0.56|TWO_SIDED|95.0|-13.6|9.0||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||9.0|-13.6|0.56
71891634|NCT00110305|143304580|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||0.62|TWO_SIDED|95.0|-14.0|8.4||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||8.4|-14.0|0.62
71891635|NCT00110305|143304580|SUPERIORITY_OR_OTHER||Difference in response rate|-1.5||||0.8|TWO_SIDED|95.0|-10.5|7.5||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.5|-10.5|0.80
71891636|NCT00110305|143304581|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.1|7.6||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N\[t\]RTIs) used, and baseline viral load as covariate.||||7.6|-17.1|0.45
71891637|NCT00110305|143304581|SUPERIORITY_OR_OTHER||Difference in response rate|-4.8||||0.45|TWO_SIDED|95.0|-17.3|7.7||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||7.7|-17.3|0.45
71891638|NCT00110305|143304581|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||0.99|TWO_SIDED|95.0|-12.9|12.8||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||12.8|-12.9|0.99
71891639|NCT00110305|143304581|SUPERIORITY_OR_OTHER||Differences in response|2.6||||0.63|TWO_SIDED|95.0|-8.1|13.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.||||13.3|-8.1|0.63
71891640|NCT00110305|143304583|SUPERIORITY_OR_OTHER||Difference in response rate|-2.8||||||95.0|-14.7|9.1||||||||9.1|-14.7|
71668542|NCT02273388|142853499|OTHER||Difference of adjusted means|-4.56|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-10.59|1.48|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 5 minutes before infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||1.48|-10.59|
71891641|NCT02354833|143304623|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
71891642|NCT02354833|143304624|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||This analysis is comparing the percentage of participants with Nausea||||0.28
71891643|NCT02354833|143304624|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||This analysis is comparing the percentage of participants with Emesis||||< 0.001
71891644|NCT02354833|143304625|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
71891645|NCT02354833|143304626|SUPERIORITY_OR_OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71668543|NCT02273388|142853499|OTHER||Difference of adjusted means|-7.14|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-13.18|-1.11|||||Comparison vs. 1hour infusion \[2h-1h\]|Change from baseline to 1 hour after infusion end. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-1.11|-13.18|
71782549|NCT03385564|143064287|OTHER||Difference|-9.14||||0.825|TWO_SIDED|80.0|-32.83|17.02|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||17.02|-32.83|0.8250
71891646|NCT05040971|143304627|SUPERIORITY|Week 52 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment as factor and baseline body weight as covariate.|Treatment difference|-11.19|||<|0.0001|TWO_SIDED|95.0|-12.97|-9.42|||ANCOVA|||Treatment policy estimand||-9.42|-12.97|<0.0001
71891647|NCT05040971|143304628|SUPERIORITY|Week 52 responses were analysed using a logistic regression model with randomised treatment as factor and baseline glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG) as covariates.|Odds Ratio (OR)|19.81|||<|0.0001|TWO_SIDED|95.0|8.68|45.21|||Regression, Logistic|||Treatment policy estimand||45.21|8.68|<0.0001
71891648|NCT02623972|143304655|OTHER||Pathelogic Complete Response Rate|30.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 10% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 30% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.10, Alternative hypothesis that proportion pCR ≥ 0.30. Hypothesized False Positive Rate(α)=10%; Hypothesized False Negative Rate(1-β)=10%.||||
71891649|NCT02623972|143304655|OTHER||Pathelogic Complete Response Rate|23.0|||||TWO_SIDED||||||Simon minimax two-stage design||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 2% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 23% then the regimen is worthy of further study.|Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.02, Alternative hypothesis that proportion pCR ≥ 0.23. Hypothesized False Positive Rate(α)=5%; Hypothesized False Negative Rate(1-β)=10%.||||
71891650|NCT03878147|143304660|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|2.39|STANDARD_ERROR_OF_MEAN|0.82|<|0.01|TWO_SIDED|95.0|0.78|4.01||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||4.01|0.78|<.01
71891651|NCT03878147|143304660|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.82||0.32|TWO_SIDED|95.0|-0.8|2.44||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||2.44|-0.80|.32
71891652|NCT03878147|143304660|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|0.99||0.07|TWO_SIDED|95.0|-3.74|0.16||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.16|-3.74|.07
71891653|NCT03878147|143304660|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.96||0.83|TWO_SIDED|95.0|-2.1|1.68||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||1.68|-2.10|.83
71668544|NCT02273388|142853499|OTHER||Difference of adjusted means|-3.58|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-9.61|2.46|||||Comparison vs. 1 hour infusion \[2h-1h\]|Change from baseline to 4 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||2.46|-9.61|
71782550|NCT03385564|143064287|OTHER||Difference|-21.23||||0.2562|TWO_SIDED|80.0|-39.44|0.51|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||0.51|-39.44|0.2562
71782551|NCT03385564|143064287|OTHER||Difference|-2.0||||0.9632|TWO_SIDED|80.0|-20.45|16.62|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||16.62|-20.45|0.9632
71782552|NCT03385564|143064288|OTHER||Difference|-2.86||||0.9275|TWO_SIDED|80.0|-28.58|21.1|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||21.10|-28.58|0.9275
71782553|NCT03385564|143064288|OTHER||Difference|-10.0||||0.6064|TWO_SIDED|80.0|-29.9|10.64|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||10.64|-29.90|0.6064
71782554|NCT03385564|143064288|OTHER||Difference|0.0|||||TWO_SIDED|80.0|-18.37|18.07|||||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||18.07|-18.37|
71782555|NCT03385564|143064289|OTHER||Difference|3.73||||0.9119|TWO_SIDED|80.0|-20.53|29.6|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||29.60|-20.53|0.9119
71782556|NCT03385564|143064289|OTHER||Difference|3.73||||0.851|TWO_SIDED|80.0|-16.58|24.31|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||24.31|-16.58|0.8510
71782557|NCT03385564|143064289|OTHER||Difference|16.43||||0.3498|TWO_SIDED|80.0|-3.53|34.73|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||34.73|-3.53|0.3498
71750166|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4628|TWO_SIDED|95.0|0.54|3.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.81|0.54|0.4628
71891654|NCT03878147|143304661|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.65|TWO_SIDED|95.0|-0.71|0.42||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.42|-0.71|.65
71891655|NCT03878147|143304661|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.29||0.95|TWO_SIDED|95.0|-0.54|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.54|.95
71891656|NCT03878147|143304661|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.34|TWO_SIDED|95.0|-0.92|0.13||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.13|-0.92|.34
71750167|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.51||||0.4015|TWO_SIDED|95.0|0.58|3.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.92|0.58|0.4015
71750168|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.39||||0.0031|TWO_SIDED|95.0|1.76|16.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||16.47|1.76|0.0031
71750169|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.15||||0.0115|TWO_SIDED|95.0|1.38|12.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.50|1.38|0.0115
71750170|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.81||||0.2513|TWO_SIDED|95.0|0.66|4.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.98|0.66|0.2513
71750171|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0099|TWO_SIDED|95.0|1.39|11.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.14|1.39|0.0099
71750172|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0242|TWO_SIDED|95.0|1.16|8.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.74|1.16|0.0242
71750173|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1518|TWO_SIDED|95.0|0.77|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.60|0.77|0.1518
71750174|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.95||||0.1811|TWO_SIDED|95.0|0.73|5.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.17|0.73|0.1811
71750175|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.88||||0.015|TWO_SIDED|95.0|1.3|11.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.55|1.30|0.0150
71750176|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0046|TWO_SIDED|95.0|1.67|16.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.68|1.67|0.0046
71750177|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3788|TWO_SIDED|95.0|0.57|4.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.34|0.57|0.3788
71668545|NCT02273388|142853499|OTHER||Difference of adjusted means|-8.66|STANDARD_ERROR_OF_MEAN|3.61|||TWO_SIDED|90.0|-14.7|-2.63|||||Comparison vs. 1 hour \[2h-1h\]|Change from baseline to 24 hours after infusion start. Linear mixed model with sequence, course, treatment (both infusion types i.e. 1 hour duration and 2 hour duration) and time as fixed effects and treatment\*time as interaction effect, as well as the continuous , fixed covariate of baseline value.||-2.63|-14.70|
71835677|NCT03052608|143176447|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.414|1.249|||||Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.249|0.414|
71835678|NCT03052608|143176448|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.144|0.307|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.307|0.144|<0.0001
71668546|NCT04331808|142853523|SUPERIORITY||Median posterior absolute risk differenc|-9.0|||||TWO_SIDED|90.0|-21.0|3.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credibility interval here|||3.1|-21.0|
71835679|NCT03052608|143176449|SUPERIORITY||Odds Ratio (OR)|2.254||||0.0005|TWO_SIDED|95.0|1.353|3.891|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||3.891|1.353|0.0005
71835680|NCT03052608|143176450|SUPERIORITY||Odds Ratio (OR)|2.499||||0.0002|TWO_SIDED|95.0|1.484|4.594|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||4.594|1.484|0.0002
71835681|NCT03052608|143176451|SUPERIORITY||Odds Ratio (OR)|8.407|||<|0.0001|TWO_SIDED|95.0|2.586|27.233|||Cochran-Mantel-Haenszel|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Odds ratio was estimated using Mantel-Haenszel method. An odds ratio larger than 1 indicates better outcome for Lorlatinib relative to Crizotinib. Exact CI was calculated.|||27.233|2.586|<0.0001
71835682|NCT03052608|143176452|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.026|0.17|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||0.170|0.026|<0.0001
71835683|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|4.65||||0.0096|TWO_SIDED|95.0|1.14|8.16|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||8.16|1.14|0.0096
71750178|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0424|TWO_SIDED|95.0|1.04|7.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.70|1.04|0.0424
71750179|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.69||||0.0139|TWO_SIDED|95.0|1.3|10.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||10.43|1.30|0.0139
71750180|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.67||||0.3057|TWO_SIDED|95.0|0.63|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.63|0.3057
71750181|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.55||||0.3717|TWO_SIDED|95.0|0.59|4.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.02|0.59|0.3717
71750182|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0252|TWO_SIDED|95.0|1.16|9.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||9.50|1.16|0.0252
71750183|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0235|TWO_SIDED|95.0|1.19|10.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.69|1.19|0.0235
71750184|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.25||||0.658|TWO_SIDED|95.0|0.46|3.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.39|0.46|0.6580
71750185|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.58||||0.0061|TWO_SIDED|95.0|1.54|13.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||13.62|1.54|0.0061
71750186|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0149|TWO_SIDED|95.0|1.29|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.61|1.29|0.0149
71750187|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9282|TWO_SIDED|95.0|0.35|2.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.62|0.35|0.9282
71668547|NCT04331808|142853524|SUPERIORITY||Median posterior Hazard Ratio|0.58|||||TWO_SIDED|90.0|0.33|1.0||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||1.00|0.33|
71782558|NCT03385564|143064290|OTHER||Difference|5.43||||0.7921|TWO_SIDED|80.0|-10.19|23.57|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.57|-10.19|0.7921
71668548|NCT04331808|142853525|SUPERIORITY||Median posterior absolute risk differenc|1.7|||||TWO_SIDED|90.0|-13.6|17.1||Posterior probability|Bayesian analysis|Adjusted for age and centre|% Confidence Interval is % Credible Interval here Results are presented as the proportion not improved, so that an effective treatment would be associated with a decrease in proportion.|||17.1|-13.6|
71750188|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7902|TWO_SIDED|95.0|0.33|2.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.35|0.33|0.7902
71750189|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.22||||0.1603|TWO_SIDED|95.0|0.73|6.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.74|0.73|0.1603
71750190|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1144|TWO_SIDED|95.0|0.8|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||8.14|0.80|0.1144
71750191|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5903|TWO_SIDED|95.0|0.26|2.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||2.13|0.26|0.5903
71750192|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.89||||0.029|TWO_SIDED|95.0|1.15|13.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||13.16|1.15|0.0290
71750193|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1721|TWO_SIDED|95.0|0.72|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.26|0.72|0.1721
71750194|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2439|TWO_SIDED|95.0|0.66|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.09|0.66|0.2439
71750195|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7402|TWO_SIDED|95.0|0.44|3.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.19|0.44|0.7402
71750196|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0422|TWO_SIDED|95.0|1.04|9.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.63|1.04|0.0422
71750197|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.44||||0.0061|TWO_SIDED|95.0|1.62|18.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.27|1.62|0.0061
71750198|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3191|TWO_SIDED|95.0|0.59|4.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.92|0.59|0.3191
71750199|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.91||||0.0037|TWO_SIDED|95.0|1.78|19.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.66|1.78|0.0037
71750200|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0139|TWO_SIDED|95.0|1.33|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.20|1.33|0.0139
71750201|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.59||||0.3757|TWO_SIDED|95.0|0.57|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.42|0.57|0.3757
71891657|NCT03878147|143304661|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.33||0.81|TWO_SIDED|95.0|-0.73|0.58||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.58|-0.73|.81
71891658|NCT03878147|143304662|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Median Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|0.004|0.043||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.043|0.004|.01
71891659|NCT03878147|143304662|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 6.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|0.003|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.040|0.003|.02
71668549|NCT04331808|142853526|SUPERIORITY||Median posterior Hazard Ratio|1.19|||||TWO_SIDED|90.0|0.71|2.04||Posterior probability|Bayesian analysis|HR adjusted for age and centre|% Confidence interval is % Credible Interval here|||2.04|0.71|
71750202|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7087|TWO_SIDED|95.0|0.45|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.28|0.45|0.7087
71750203|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.53||||0.1083|TWO_SIDED|95.0|0.81|7.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.88|0.81|0.1083
71750204|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0473|TWO_SIDED|95.0|1.01|10.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.14|1.01|0.0473
71750205|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2481|TWO_SIDED|95.0|0.64|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.64|0.2481
71750206|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|5.84||||0.0066|TWO_SIDED|95.0|1.64|20.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||20.89|1.64|0.0066
71750207|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0466|TWO_SIDED|95.0|1.02|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.18|1.02|0.0466
71750208|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8769|TWO_SIDED|95.0|0.34|2.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||2.53|0.34|0.8769
71782559|NCT03385564|143064292|OTHER||Difference|32.0||||0.1016|TWO_SIDED|80.0|10.28|44.74|||Barnard test||The difference was calculated as value from BI 120 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||44.74|10.28|0.1016
71668550|NCT04331808|142853527|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.4|3.55|||Regression, Cox|adjusted for age and sex||Day 14||3.55|0.40|
71668551|NCT04331808|142853527|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.33|2.53|||Regression, Cox|adjusted for age and centre||Day 28||2.53|0.33|
71668552|NCT04331808|142853527|SUPERIORITY||Cox Proportional Hazard|0.64|||||TWO_SIDED|95.0|0.25|1.65|||Regression, Cox|adjusted for age and centre||Day 90||1.65|0.25|
71750209|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.37||||0.5448|TWO_SIDED|95.0|0.49|3.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.82|0.49|0.5448
71782560|NCT03385564|143064292|OTHER||Difference|-3.71||||0.8323|TWO_SIDED|80.0|-23.79|15.29|||Barnard test||The difference was calculated as value from BI 180 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||15.29|-23.79|0.8323
71750210|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.57||||0.4125|TWO_SIDED|95.0|0.53|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.64|0.53|0.4125
71668553|NCT04331808|142853527|SUPERIORITY||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.12|1.15|||Regression, Cox|adjusted for age and centre||Day 14||1.15|0.12|
71668554|NCT04331808|142853527|SUPERIORITY||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Regression, Cox|adjusted for age and centre||Day 28||1.47|0.32|
71750211|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.36||||0.05|TWO_SIDED|95.0|1.0|11.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.30|1.00|0.0500
71750212|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6167|TWO_SIDED|95.0|0.45|3.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.87|0.45|0.6167
71750213|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0233|TWO_SIDED|95.0|1.21|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||13.26|1.21|0.0233
71750214|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0803|TWO_SIDED|95.0|0.89|8.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.09|0.89|0.0803
71750215|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1274|TWO_SIDED|95.0|0.76|9.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.18|0.76|0.1274
71750216|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.05||||0.9445|TWO_SIDED|95.0|0.29|3.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.71|0.29|0.9445
71750217|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4204|TWO_SIDED|95.0|0.47|6.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.03|0.47|0.4204
71750218|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.78||||0.1315|TWO_SIDED|95.0|0.74|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.49|0.74|0.1315
71750219|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0944|TWO_SIDED|95.0|0.82|12.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.87|0.82|0.0944
71750220|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.99||||0.2801|TWO_SIDED|95.0|0.57|6.89||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||6.89|0.57|0.2801
71750221|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1524|TWO_SIDED|95.0|0.72|8.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.30|0.72|0.1524
71750222|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6129|TWO_SIDED|95.0|0.4|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.75|0.40|0.6129
71750223|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4617|TWO_SIDED|95.0|0.18|2.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.18|0.18|0.4617
71750224|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6519|TWO_SIDED|95.0|0.2|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.70|0.20|0.6519
71750225|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.84||||0.8011|TWO_SIDED|95.0|0.22|3.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.18|0.22|0.8011
71750226|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.95||||0.3254|TWO_SIDED|95.0|0.51|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.41|0.51|0.3254
71750227|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|2.0||||0.273|TWO_SIDED|95.0|0.58|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.94|0.58|0.2730
71750228|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6601|TWO_SIDED|95.0|0.39|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.41|0.39|0.6601
71750229|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.74||||0.6588|TWO_SIDED|95.0|0.2|2.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.76|0.20|0.6588
71750230|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3257|TWO_SIDED|95.0|0.14|1.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.92|0.14|0.3257
71750231|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.42||||0.2229|TWO_SIDED|95.0|0.1|1.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.69|0.10|0.2229
71750232|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.43||||0.2425|TWO_SIDED|95.0|0.1|1.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.77|0.10|0.2425
71750233|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9672|TWO_SIDED|95.0|0.23|4.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.11|0.23|0.9672
71782561|NCT03385564|143064292|OTHER||Difference|7.0||||0.6247|TWO_SIDED|80.0|-10.5|23.31|||Barnard test||The difference was calculated as value from BI 240 milligrams group minus value from Placebo group. Confidence intervals calculated using the Newcombe method.|||23.31|-10.50|0.6247
71782562|NCT02610725|143064331|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|0.81||0.013|TWO_SIDED|95.0|-3.73|-0.46|||t-test, 2 sided|51 degrees of freedom.|Means were analyzed in (pre-post) format. A negative mean here indicates an increase in positive affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.||-0.46|-3.73|0.013
71782563|NCT02610725|143064331|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|4.1|8.02|||t-test, 2 sided|51 degrees of freedom|Means were analyzed in a (pre-post) format. A positive mean indicates a decrease in negative affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.||8.02|4.10|<0.001
71782564|NCT00826943|143064338|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.03
71750234|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|1.43||||0.5838|TWO_SIDED|95.0|0.4|5.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.09|0.40|0.5838
71750235|NCT03192176|143005312|SUPERIORITY||Odds Ratio (OR)|0.95||||0.9361|TWO_SIDED|95.0|0.28|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.24|0.28|0.9361
71750236|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0429|TWO_SIDED|95.0|1.03|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.55|1.03|0.0429
71750237|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0296|TWO_SIDED|95.0|1.11|7.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||7.12|1.11|0.0296
71782565|NCT00826943|143064338|SUPERIORITY_OR_OTHER|||||||0.11||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.11
71782566|NCT00826943|143064338|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||.45
71750238|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.48||||0.0032|TWO_SIDED|95.0|1.65|12.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.13|1.65|0.0032
71750239|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0006|TWO_SIDED|95.0|2.31|21.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||21.90|2.31|0.0006
71782567|NCT00826943|143064339|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||The threshold for significance was p \< .05.|Wilcoxon (Mann-Whitney)|||||||.27
71782568|NCT00826943|143064339|SUPERIORITY_OR_OTHER|||||||0.8||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.8
71782569|NCT00826943|143064339|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.52
71782570|NCT00826943|143064340|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||The threshold for significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||.14
71782571|NCT00826943|143064340|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||.54
71782572|NCT00826943|143064340|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||.42
71782573|NCT02302807|143064367|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.4134|TWO_SIDED|95.0|0.63|1.21|||Log Rank|||||1.21|0.63|0.4134
71782574|NCT02302807|143064367|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.71|1.05||||||||1.05|0.71|
71782575|NCT02302807|143064367|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||||0.99|0.73|
71835684|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|2.02||||0.1897|TWO_SIDED|95.0|-1.01|5.05|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.05|-1.01|0.1897
71782576|NCT03329573|143064378|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.059|||||TWO_SIDED|90.0|1.006|1.115||||||||1.115|1.006|
71782577|NCT03329573|143064379|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.947|1.047||||||||1.047|0.947|
71782578|NCT03329573|143064380|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.064|||||TWO_SIDED|90.0|1.01|1.12||||||||1.120|1.010|
71782579|NCT03329573|143064381|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||TWO_SIDED|90.0|0.949|1.044||||||||1.044|0.949|
71782580|NCT03329573|143064382|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.024|||||TWO_SIDED|90.0|0.952|1.101||||||||1.101|0.952|
71835685|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|2.09||||0.2999|TWO_SIDED|95.0|-1.87|6.04|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||6.04|-1.87|0.2999
71835686|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|2.58||||0.0553|TWO_SIDED|95.0|-0.06|5.22|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.22|-0.06|0.0553
71835687|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-3.18||||0.0588|TWO_SIDED|95.0|-6.47|0.12|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.12|-6.47|0.0588
71668555|NCT04331808|142853527|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.3|1.49|||Regression, Cox|adjusted for age and centre||Day 90||1.49|0.30|
71782581|NCT03329573|143064383|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.02|||||TWO_SIDED|90.0|0.968|1.074||||||||1.074|0.968|
71782582|NCT00650260|143064408|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||Fisher Exact|||||||0.027
71782583|NCT00650260|143064409|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 1 sided|||||||0.078
71782584|NCT00650260|143064412|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71782585|NCT00590720|143064433|SUPERIORITY_OR_OTHER|||||||0.4|||||||Two-sample t-test|||||||0.40
71782586|NCT00590720|143064434|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Two-sample t-test|||||||<0.01
71782587|NCT00590720|143064435|SUPERIORITY_OR_OTHER|||||||0.53|||||||Two-sample t-test|||||||0.53
71782588|NCT00590720|143064436|SUPERIORITY_OR_OTHER|||||||0.22|||||||Two-sample t-test|||||||0.22
71782589|NCT00590720|143064437|SUPERIORITY_OR_OTHER|||||||0.16|||||||Two-sample t-test|||||||0.16
71782590|NCT00590720|143064438|SUPERIORITY_OR_OTHER|||||||0.52|||||||Two-sample t-test|||||||0.52
71782591|NCT01001377|143064449|SUPERIORITY_OR_OTHER_LEGACY||Stratified Cox proportional hazard ratio|0.966|||||TWO_SIDED|95.0|0.839|1.113|||||Hazard ratio is presented as panitumumab : cetuximab. A value \< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.|Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).||1.113|0.839|
71782592|NCT01001377|143064449|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.|Normal score|-3.19||||0.0007||||||A synthesis approach with an asymptotic standard normal test statistic|Asymptotic standard normal test|||A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).||||0.0007
71782593|NCT01001377|143064451|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.58|||||Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).|||1.58|0.83|
71891660|NCT03878147|143304662|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.05||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.05|-0.01|.19
71891661|NCT03878147|143304662|SUPERIORITY|The key parameter was difference between least square means of trial arms at month 2.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.19|TWO_SIDED|95.0|-0.01|0.04||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates.|BPG minus waitlist control.|The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance.||0.04|-0.01|.19
71891662|NCT05817045|143304663|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.01||||0.948|TWO_SIDED|95.0|0.777|1.31|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent recurrence or disease progression (until the end of the study) Full Analysis Set (FAS)||1.310|0.777|0.948
71891663|NCT05817045|143304663|SUPERIORITY|Per-Protocol Population|Hazard Ratio (HR)|1.02||||0.902|TWO_SIDED|95.0|0.774|1.337||adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score.|NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) Per-Protocol Population||1.337|0.774|0.902
71750240|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.8||||0.2073|TWO_SIDED|95.0|0.72|4.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||4.47|0.72|0.2073
71750241|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.54||||0.0096|TWO_SIDED|95.0|1.36|9.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||9.20|1.36|0.0096
71750242|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0462|TWO_SIDED|95.0|1.02|6.27||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.27|1.02|0.0462
71750243|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1387|TWO_SIDED|95.0|0.77|6.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.63|0.77|0.1387
71782594|NCT01001377|143064455|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0126|||||TWO_SIDED|95.0|-0.0353|0.0605|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||0.0605|-0.0353|
71782595|NCT01001377|143064456|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6745|||||TWO_SIDED|95.0|-4.9331|1.5841|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||1.5841|-4.9331|
71668556|NCT04331808|142853528|SUPERIORITY||Median posterior OR|0.6|||||TWO_SIDED|95.0|0.27|1.28|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 4||1.28|0.27|
71782596|NCT01001377|143064457|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0372|||||TWO_SIDED|95.0|-2.3267|4.401|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.4010|-2.3267|
71782597|NCT01001377|143064458|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5836|||||TWO_SIDED|95.0|-3.0269|4.1941|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||4.1941|-3.0269|
71782598|NCT01001377|143064459|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1998|||||TWO_SIDED|95.0|-6.0093|5.6098|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.||5.6098|-6.0093|
71750244|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.71||||0.313|TWO_SIDED|95.0|0.6|4.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||4.84|0.60|0.3130
71750245|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0392|TWO_SIDED|95.0|1.06|10.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.40|1.06|0.0392
71750246|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0135|TWO_SIDED|95.0|1.43|22.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.71|1.43|0.0135
71750247|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.85||||0.084|TWO_SIDED|95.0|0.87|9.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||9.36|0.87|0.0840
71750248|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.47||||0.0163|TWO_SIDED|95.0|1.32|15.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||15.17|1.32|0.0163
71750249|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5056|TWO_SIDED|95.0|0.52|3.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||3.84|0.52|0.5056
71750250|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.69||||0.3358|TWO_SIDED|95.0|0.58|4.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||4.90|0.58|0.3358
71782599|NCT03600818|143064484|SUPERIORITY||Difference in percentage|18.0|||=|0.0193|TWO_SIDED|95.0|4.15|31.82||Threshold for significance at 0.05 level.|Fisher Exact|||||31.82|4.15|=0.0193
71782600|NCT03600818|143064485|SUPERIORITY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Wilcoxon rank-sum test|||A hierarchical testing procedure was used to control the overall type I error. If the primary endpoint reaches statistical significance then the secondary endpoint for total cumulative CS dose was tested next.||||<0.0001
71782601|NCT02849678|143064509|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.148|||||||t-test, 1 sided|||||||0.148
71782602|NCT02849678|143064511|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.636|||||||t-test, 1 sided|||||||.636
71668557|NCT04331808|142853528|SUPERIORITY||Median posterior OR|0.86|||||TWO_SIDED|95.0|0.43|1.71|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 7|% Confidence Interval is % Credible Interval here|1.71|0.43|
71750251|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.05||||0.0696|TWO_SIDED|95.0|0.91|10.18||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.18|0.91|0.0696
71782603|NCT02849678|143064513|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.193||||||Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU)|t-test, 2 sided|||||||0.193
71782604|NCT02849678|143064513|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.635||||||Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours|ANOVA|||||||0.635
71782605|NCT02849678|143064514|NON_INFERIORITY|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.063|||||||ANOVA|Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours||||||0.063
71782606|NCT01112865|143064554|SUPERIORITY_OR_OTHER|||||||0.6858|TWO_SIDED|||||Binomial test against the null hypothesis|binomial test|||Null hypothesis: percentage of participants preferring Genotropin Mark VII injection pen = 50%||||0.6858
71782607|NCT02228460|143064580|OTHER|||||||0.3173||||||Threshold for significance at 0.05 level.|McNemar Test|||A McNemar test was used to test the treatment effect based on paired pre-treatment and post-treatment (Week 26) frequencies of skin GL-3 score grouped into the categories (0 to \<2; 2 to 3).||||0.3173
71782608|NCT02228460|143064581|OTHER|||||||0.625||||||Threshold for significance at 0.05 level.|Wilcoxon signed rank test|||Wilcoxon signed rank test was used to assess the mean change from Baseline to Week 26 in skin GL-3 score.||||0.625
71750252|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0794|TWO_SIDED|95.0|0.89|8.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.82|0.89|0.0794
71750253|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.32||||0.0149|TWO_SIDED|95.0|1.48|36.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.28|1.48|0.0149
71750254|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.37||||0.0377|TWO_SIDED|95.0|1.09|17.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.59|1.09|0.0377
71750255|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.32||||0.0454|TWO_SIDED|95.0|1.03|10.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.77|1.03|0.0454
71750256|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.77||||0.039|TWO_SIDED|95.0|1.07|13.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||13.26|1.07|0.0390
71750257|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1947|TWO_SIDED|95.0|0.68|6.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.64|0.68|0.1947
71750258|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.79||||0.2913|TWO_SIDED|95.0|0.61|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.25|0.61|0.2913
71750259|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1665|TWO_SIDED|95.0|0.72|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.82|0.72|0.1665
71750260|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|13.41||||0.0157|TWO_SIDED|95.0|1.63|110.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||110.3|1.63|0.0157
71750261|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0846|TWO_SIDED|95.0|0.86|10.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.49|0.86|0.0846
71750262|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.42||||0.0171|TWO_SIDED|95.0|1.35|21.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||21.75|1.35|0.0171
71750263|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.71||||0.0262|TWO_SIDED|95.0|1.2|18.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||18.49|1.20|0.0262
71750264|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2858|TWO_SIDED|95.0|0.59|5.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.95|0.59|0.2858
71750265|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0155|TWO_SIDED|95.0|1.47|39.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||39.72|1.47|0.0155
71750266|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.66||||0.1249|TWO_SIDED|95.0|0.76|9.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||9.31|0.76|0.1249
71750267|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0616|TWO_SIDED|95.0|0.94|15.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||15.82|0.94|0.0616
71750268|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|8.32||||0.0126|TWO_SIDED|95.0|1.58|43.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||43.90|1.58|0.0126
71750269|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0853|TWO_SIDED|95.0|0.85|11.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.23|0.85|0.0853
71782609|NCT03982368|143064608|SUPERIORITY||least square mean difference|0.93||||0.078|TWO_SIDED|95.0|-1.47|3.32|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||3.32|-1.47|0.078
71750270|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.56||||0.1562|TWO_SIDED|95.0|0.7|9.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.35|0.70|0.1562
71750271|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1297|TWO_SIDED|95.0|0.74|10.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||10.91|0.74|0.1297
71750272|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.34||||0.2001|TWO_SIDED|95.0|0.64|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||8.55|0.64|0.2001
71750273|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0495|TWO_SIDED|95.0|1.0|73.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||73.70|1.00|0.0495
71750274|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.86||||0.1553|TWO_SIDED|95.0|0.67|12.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||12.20|0.67|0.1553
71750275|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.67||||0.0199|TWO_SIDED|95.0|1.38|42.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||42.67|1.38|0.0199
71668558|NCT04331808|142853528|SUPERIORITY||Median posterior OR|0.76|||||TWO_SIDED|95.0|0.4|1.42|||Proportionnal odds model|Bayesian analysis. Adjusted for age and sex|% Confidence Interval is % Credible Interval here|Day 14||1.42|0.40|
71750276|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.28||||0.0472|TWO_SIDED|95.0|1.02|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||27.34|1.02|0.0472
71750277|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3736|TWO_SIDED|95.0|0.51|5.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.98|0.51|0.3736
71750278|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.06||||0.2628|TWO_SIDED|95.0|0.58|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.26|0.58|0.2628
71668559|NCT04331808|142853528|SUPERIORITY||Median posterior OR|0.85|||||TWO_SIDED|95.0|0.39|1.82|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre||Day 4|% Confidence Interval is % Credible Interval here|1.82|0.39|
71750279|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1998|TWO_SIDED|95.0|0.63|9.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.39|0.63|0.1998
71750280|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.89||||0.1507|TWO_SIDED|95.0|0.68|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.28|0.68|0.1507
71750281|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.92||||0.0385|TWO_SIDED|95.0|1.1|31.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||31.94|1.10|0.0385
71782610|NCT03982368|143064608|SUPERIORITY||least square mean difference|2.31||||0.066|TWO_SIDED|95.0|-0.08|4.7|||ANOVA|||The primary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.70|-0.08|0.066
71782611|NCT03982368|143064609|SUPERIORITY||Least square mean difference|1.71||||0.032|TWO_SIDED|95.0|-0.7|4.12|||ANOVA|||||4.12|-0.70|0.032
71782612|NCT03982368|143064609|SUPERIORITY||Least square mean difference|2.44||||0.029|TWO_SIDED|95.0|0.02|4.86|||ANOVA|||||4.86|0.02|0.029
71782613|NCT03982368|143064610|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||||||0.534
71782614|NCT03982368|143064610|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
71782615|NCT03982368|143064611|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||0.486
71782616|NCT03982368|143064611|SUPERIORITY|||||||0.564|||||||t-test, 2 sided|||||||0.564
71782617|NCT03982368|143064613|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.810
71782618|NCT03982368|143064613|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||||||0.733
71835688|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|2.27||||0.2118|TWO_SIDED|95.0|-1.3|5.85|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.85|-1.30|0.2118
71835689|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-5.67||||0.0032|TWO_SIDED|95.0|-9.42|-1.92|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.92|-9.42|0.0032
71835690|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-7.86|||<|0.0001|TWO_SIDED|95.0|-9.86|-5.86|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-5.86|-9.86|<0.0001
71750282|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|10.85||||0.0299|TWO_SIDED|95.0|1.26|93.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||93.28|1.26|0.0299
71750283|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.19||||0.8034|TWO_SIDED|95.0|0.3|4.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.74|0.30|0.8034
71750284|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.14||||0.8532|TWO_SIDED|95.0|0.29|4.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.42|0.29|0.8532
71750285|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8823|TWO_SIDED|95.0|0.28|4.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.41|0.28|0.8823
71750286|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.79||||0.1651|TWO_SIDED|95.0|0.52|43.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||43.76|0.52|0.1651
71750287|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|6.36||||0.1048|TWO_SIDED|95.0|0.68|59.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||59.55|0.68|0.1048
71835691|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|1.16||||0.531|TWO_SIDED|95.0|-2.49|4.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.82|-2.49|0.5310
71835692|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|1.72||||0.3602|TWO_SIDED|95.0|-1.98|5.43|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||5.43|-1.98|0.3602
71835693|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-7.95|||<|0.0001|TWO_SIDED|95.0|-11.25|-4.64|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-4.64|-11.25|<0.0001
71835694|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-9.21|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.62|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-6.62|-11.80|<0.0001
71835695|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-4.93||||0.0198|TWO_SIDED|95.0|-9.07|-0.79|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Constipation. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-0.79|-9.07|0.0198
71750288|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.87||||0.1168|TWO_SIDED|95.0|0.64|53.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||53.53|0.64|0.1168
71750289|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.31||||0.6936|TWO_SIDED|95.0|0.35|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.95|0.35|0.6936
71891664|NCT05817045|143304663|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.02||||0.859|TWO_SIDED|95.0|0.782|1.342|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to sustained resolution of COVID-19 signs and symptoms without subsequent symptom recurrence or disease progression (until the end of the study) - Secondary Analysis (FAS excluding subjects that were qPCR negative at baseline)||1.342|0.782|0.859
71782619|NCT03982368|143064614|SUPERIORITY||Least square mean difference|1.97||||0.025|TWO_SIDED|95.0|-0.19|4.13|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||4.13|-0.19|0.025
71835696|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-12.03|||<|0.0001|TWO_SIDED|95.0|-15.49|-8.58|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Diarrhea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-8.58|-15.49|<0.0001
71750290|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.74||||0.4315|TWO_SIDED|95.0|0.44|6.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.90|0.44|0.4315
71750291|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7936|TWO_SIDED|95.0|0.31|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.53|0.31|0.7936
71750292|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|6.3||||0.099|TWO_SIDED|95.0|0.71|56.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||56.03|0.71|0.0990
71750293|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.86||||0.1128|TWO_SIDED|95.0|0.66|52.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||52.21|0.66|0.1128
71750294|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0732|TWO_SIDED|95.0|0.83|65.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||65.38|0.83|0.0732
71782620|NCT03982368|143064614|SUPERIORITY||Least square mean difference|0.68||||0.243|TWO_SIDED|95.0|-1.48|2.83|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||2.83|-1.48|0.243
71835697|NCT03052608|143176467|SUPERIORITY||Mean Difference (Net)|-1.04||||0.5947|TWO_SIDED|95.0|-4.9|2.82|||Mixed Models Analysis|||This is the analysis for QLQ-C30 Financial Difficulties. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||2.82|-4.90|0.5947
71835698|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|0.55||||0.7254|TWO_SIDED|95.0|-2.51|3.6|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.60|-2.51|0.7254
71835699|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|-4.55||||0.0115|TWO_SIDED|95.0|-8.06|-1.03|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Coughing. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||-1.03|-8.06|0.0115
71750295|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.39||||0.6559|TWO_SIDED|95.0|0.33|5.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.91|0.33|0.6559
71750296|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7333|TWO_SIDED|95.0|0.21|2.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||2.96|0.21|0.7333
71750297|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|0.94||||0.9266|TWO_SIDED|95.0|0.24|3.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.74|0.24|0.9266
71750298|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.04||||0.1518|TWO_SIDED|95.0|0.55|46.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||46.13|0.55|0.1518
71750299|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.69||||0.1714|TWO_SIDED|95.0|0.51|42.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||42.91|0.51|0.1714
71782621|NCT03982368|143064615|SUPERIORITY||Least square mean difference|2.41||||0.007|TWO_SIDED|95.0|0.28|4.54|||ANOVA|||||4.54|0.28|0.007
71835700|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|0.12||||0.7824|TWO_SIDED|95.0|-0.75|0.99|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Haemoptysis. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.99|-0.75|0.7824
71835701|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|1.16||||0.2988|TWO_SIDED|95.0|-1.04|3.36|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Sore Mouth. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.36|-1.04|0.2988
71835702|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|-1.51||||0.1916|TWO_SIDED|95.0|-3.79|0.76|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Dysphagia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||0.76|-3.79|0.1916
71835703|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|5.37||||0.0279|TWO_SIDED|95.0|0.59|10.15|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Peripheral Neuropathy. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||10.15|0.59|0.0279
71835704|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|-0.2||||0.9162|TWO_SIDED|95.0|-3.89|3.49|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Alopecia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||3.49|-3.89|0.9162
71835705|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|-0.53||||0.6698|TWO_SIDED|95.0|-2.96|1.9|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Chest. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||1.90|-2.96|0.6698
71835706|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|0.45||||0.8035|TWO_SIDED|95.0|-3.13|4.04|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Arm or Shoulder. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||4.04|-3.13|0.8035
71835707|NCT03052608|143176468|SUPERIORITY||Mean Difference (Net)|3.36||||0.1143|TWO_SIDED|95.0|-0.82|7.55|||Mixed Models Analysis|||This is the analysis for QLQ-LC13 Pain in Other Parts. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.||7.55|-0.82|0.1143
71835708|NCT03052608|143176471|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7293|TWO_SIDED|95.0|0.822|1.444|||one-sided stratified log-rank|Stratified by the presence of brain metastases (Yes/No) and ethnic origin (Asian/Non-Asian) at randomization.|Based on Cox Proportional Hazards model stratified by the presence of brain metastases and ethnic origin at randomization. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Lorlatinib.|||1.444|0.822|0.7293
71668560|NCT04331808|142853528|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.32|1.47|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 7||1.47|0.32|
71835709|NCT04204278|143176484|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71835710|NCT04204278|143176485|OTHER||||||<|0.0001|||||||t-test, 1 sided|P-Value was calculated||||||<0.0001
71835711|NCT04204278|143176486|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71835712|NCT05249439|143176493|OTHER|Paired t-test|Mean Difference (Final Values)|-12.99|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||I-SatPro starting weight Vs 52 week weight (kg)||||<0.0001
71835713|NCT05873751|143176538|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
71835714|NCT05873751|143176539|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
71835715|NCT05873751|143176540|OTHER||Calibrated VE|2.74|||||TWO_SIDED|95.0|-10.35|15.59|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||15.59|-10.35|
71835716|NCT05873751|143176541|OTHER||Calibrated VE|-2.2|||||TWO_SIDED|95.0|-23.5|13.85|||||VE = 1 - HR\*100. The HRs were estimated by exponentiating the coefficient for the vaccine variable in the model. VE was adjusted for the covariates age, gender, and US census region.|||13.85|-23.50|
71835717|NCT02140645|143176563|SUPERIORITY_OR_OTHER||C-statistics|0.624|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835718|NCT02140645|143176564|SUPERIORITY_OR_OTHER||C-statistcs|0.597|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835719|NCT02140645|143176565|SUPERIORITY_OR_OTHER||R-squared|0.0858|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835720|NCT02140645|143176566|SUPERIORITY_OR_OTHER||C-statistics|0.623|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71668561|NCT04331808|142853528|SUPERIORITY||Median posterior OR|0.68|||||TWO_SIDED|95.0|0.32|1.43|||Proportionnal odds model|Bayesian analysis. Adjusted for age and centre|% Confidence Interval is % Credible Interval here|Day 14||1.43|0.32|
71668562|NCT04331808|142853529|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-6.9|1.7||adjusted on age and centre||||||1.7|-6.9|
71668563|NCT04331808|142853530|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.98|2.01|||Fine-Gray model|adjusted for age and centre||Day 28||2.01|0.98|
71750300|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.6||||0.1299|TWO_SIDED|95.0|0.6|51.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||51.95|0.60|0.1299
71782622|NCT03982368|143064615|SUPERIORITY||Least square mean difference|0.71||||0.23|TWO_SIDED|95.0|-1.43|2.85|||ANOVA|||||2.85|-1.43|0.230
71782623|NCT03982368|143064616|SUPERIORITY||Least square mean difference|-1.16||||0.799|TWO_SIDED|95.0|-3.11|0.8|||ANOVA|Last Observation Carried Forward (LOCF) was used for imputing missing data in the Full analysis set at Week 4.||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.80|-3.11|0.799
71668564|NCT04331808|142853530|SUPERIORITY||Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.82|2.52|||Fine-Gray model|||Day 28||2.52|0.82|
71668565|NCT04331808|142853530|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.8|2.03|||Fine-Gray model|adjusted on age and centre||Day 90||2.03|0.80|
71668566|NCT04331808|142853531|SUPERIORITY||Hazard Ratio (HR)|1.52|||||TWO_SIDED|95.0|1.02|2.27|||Fine-Gray model|adjusted on age and centre||Day 28||2.27|1.02|
71668567|NCT04331808|142853531|SUPERIORITY||Hazard Ratio (HR)|1.45|||||TWO_SIDED|95.0|0.8|2.63|||Fine-Gray model|adjusted for age and centre||Day 28||2.63|0.80|
71668568|NCT04331808|142853531|SUPERIORITY||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.84|2.17|||Fine-Gray model|adjusted for age and centre||Day 90||2.17|0.84|
71668569|NCT04331808|142853532|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.73|1.81|||Fine-Gray model|adjusted on age and centre||Day 28||1.81|0.73|
71750301|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.75||||0.2495|TWO_SIDED|95.0|0.49|15.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||15.44|0.49|0.2495
71750302|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.32||||0.7065|TWO_SIDED|95.0|0.31|5.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.60|0.31|0.7065
71668570|NCT04331808|142853532|SUPERIORITY||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|0.73|2.24|||Fine-Gray model|adjusted on age and centre||Day 90||2.24|0.73|
71750303|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.26||||0.7504|TWO_SIDED|95.0|0.3|5.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.24|0.30|0.7504
71750304|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7862|TWO_SIDED|95.0|0.21|3.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.29|0.21|0.7862
71750305|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.98||||0.155|TWO_SIDED|95.0|0.54|45.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||45.59|0.54|0.1550
71750306|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.7||||0.1706|TWO_SIDED|95.0|0.51|42.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||42.96|0.51|0.1706
71750307|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.31||||0.1415|TWO_SIDED|95.0|0.57|49.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||49.11|0.57|0.1415
71750308|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.67||||0.1241|TWO_SIDED|95.0|0.62|51.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||51.74|0.62|0.1241
71750309|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.64||||0.2169|TWO_SIDED|95.0|0.57|12.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.29|0.57|0.2169
71750310|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9982|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.60|0.28|0.9982
71750311|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.57||||0.5364|TWO_SIDED|95.0|0.38|6.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.54|0.38|0.5364
71750312|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.68||||0.121|TWO_SIDED|95.0|0.63|51.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||51.07|0.63|0.1210
71835721|NCT02140645|143176567|SUPERIORITY_OR_OTHER||R-squared|0.1753|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71891665|NCT05817045|143304665|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.29||||0.017|TWO_SIDED|95.0|1.047|1.596|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virologic rebound (during the subject's remaining time on study) Full Analysis Set (FAS)||1.596|1.047|0.017
71835722|NCT02140645|143176568|SUPERIORITY_OR_OTHER||C-statistics|0.699|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71750313|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.65||||0.0726|TWO_SIDED|95.0|0.83|70.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||70.58|0.83|0.0726
71835723|NCT02140645|143176569|SUPERIORITY_OR_OTHER||C-statistics|0.683|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835724|NCT02140645|143176570|SUPERIORITY_OR_OTHER||C-statistics|0.757|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71750314|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|7.34||||0.0749|TWO_SIDED|95.0|0.82|65.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||65.81|0.82|0.0749
71750315|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.01||||0.053|TWO_SIDED|95.0|0.98|16.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.35|0.98|0.0530
71750316|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.32||||0.2134|TWO_SIDED|95.0|0.62|8.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.72|0.62|0.2134
71750317|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.88||||0.3688|TWO_SIDED|95.0|0.48|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.41|0.48|0.3688
71750318|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|4.61||||0.0563|TWO_SIDED|95.0|0.96|22.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||22.11|0.96|0.0563
71750319|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.94||||0.0935|TWO_SIDED|95.0|0.79|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||19.52|0.79|0.0935
71750320|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0901|TWO_SIDED|95.0|0.81|16.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||16.93|0.81|0.0901
71750321|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|2.84||||0.1366|TWO_SIDED|95.0|0.72|11.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.26|0.72|0.1366
71750322|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.19||||0.7876|TWO_SIDED|95.0|0.34|4.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.08|0.34|0.7876
71750323|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4658|TWO_SIDED|95.0|0.45|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.59|0.45|0.4658
71750324|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8707|TWO_SIDED|95.0|0.25|3.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.20|0.25|0.8707
71750325|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.89||||0.3584|TWO_SIDED|95.0|0.49|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.36|0.49|0.3584
71750326|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|3.13||||0.1455|TWO_SIDED|95.0|0.67|14.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||14.57|0.67|0.1455
71750327|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0661|TWO_SIDED|95.0|0.9|28.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||28.66|0.90|0.0661
71782624|NCT03982368|143064616|SUPERIORITY||Least square mean difference|-0.36||||0.715|TWO_SIDED|95.0|-2.3|1.59|||ANOVA|||The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.||1.59|-2.30|0.715
71782625|NCT03982368|143064617|SUPERIORITY||Least square mean difference|-1.54||||0.831|TWO_SIDED|95.0|-3.4|0.31|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||0.31|-3.40|0.831
71782626|NCT03982368|143064617|SUPERIORITY||Least square mean difference|-0.21||||0.75|TWO_SIDED|95.0|-2.07|1.66|||ANOVA|||"The secondary endpoint was analyzed using analysis of variance (ANOVA) including only treatment as the main factor, followed by preplanned comparisons from vehicle and rhNGF dosages according to Williams' procedure.~p value for total corneal ancd conjunctival score is reported."||1.66|-2.07|0.750
71782627|NCT03982368|143064618|SUPERIORITY||Least square mean difference|0.96||||0.004|TWO_SIDED|95.0|0.17|1.75|||ANOVA|||||1.75|0.17|0.004
71835725|NCT02140645|143176571|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835726|NCT02140645|143176572|SUPERIORITY_OR_OTHER||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835727|NCT02140645|143176573|SUPERIORITY_OR_OTHER||C-statistics|0.733|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835728|NCT02140645|143176574|SUPERIORITY_OR_OTHER||C-statistics|0.827|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835729|NCT02140645|143176575|SUPERIORITY_OR_OTHER||C-statistics|0.801|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835730|NCT02140645|143176576|SUPERIORITY_OR_OTHER||C-statistics|0.836|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|||||
71835731|NCT06647238|143176577|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71835732|NCT00593489|143176600|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.24|||Poisson Regression|||The IPR was analyzed using Poisson regression with the intervention group as a class effect and the mean HbA1c at baseline as a covariate||1.24|0.8|0.96
71835733|NCT03580369|143176664|SUPERIORITY||LS Mean|-8.002|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-10.576|-5.428|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.428|-10.576|<.0001
71835734|NCT03580369|143176664|SUPERIORITY||LS mean|0.672|STANDARD_ERROR_OF_MEAN|0.939||0.7628|TWO_SIDED|95.0|-1.169|2.513|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.513|-1.169|0.7628
71750328|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.97||||0.3034|TWO_SIDED|95.0|0.54|7.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.17|0.54|0.3034
71750329|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9901|TWO_SIDED|95.0|0.28|3.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.60|0.28|0.9901
71750330|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.55||||0.507|TWO_SIDED|95.0|0.42|5.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.68|0.42|0.5070
71668571|NCT02189837|142853544|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|88.76|STANDARD_ERROR_OF_MEAN|36.67||0.018|TWO_SIDED|95.0|15.73|161.8|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||161.80|15.73|0.018
71668572|NCT02189837|142853544|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|236.35|STANDARD_ERROR_OF_MEAN|36.32|<|0.001|TWO_SIDED|95.0|164.02|308.69|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||308.69|164.02|<0.001
71668573|NCT02189837|142853544|SUPERIORITY_OR_OTHER||Treatment Effect|147.59|STANDARD_ERROR_OF_MEAN|51.61||0.005|TWO_SIDED|95.0|44.8|250.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||250.38|44.80|0.005
71750331|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7927|TWO_SIDED|95.0|0.21|3.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.26|0.21|0.7927
71750332|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4426|TWO_SIDED|95.0|0.44|6.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.69|0.44|0.4426
71750333|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|0.91||||0.8925|TWO_SIDED|95.0|0.23|3.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.56|0.23|0.8925
71750334|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4285|TWO_SIDED|95.0|0.42|7.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.52|0.42|0.4285
71750335|NCT03192176|143005313|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9|TWO_SIDED|95.0|0.31|3.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.72|0.31|0.9000
71750336|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0602|TWO_SIDED|95.0|0.96|6.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||6.06|0.96|0.0602
71750337|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|4.88||||0.001|TWO_SIDED|95.0|1.89|12.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||12.57|1.89|0.0010
71750338|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|5.24||||0.0006|TWO_SIDED|95.0|2.03|13.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||13.51|2.03|0.0006
71750339|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|9.07|||<|0.0001|TWO_SIDED|95.0|3.23|25.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||25.45|3.23|<0.0001
71750340|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1259|TWO_SIDED|95.0|0.82|5.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.22|0.82|0.1259
71750341|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|7.05|||<|0.0001|TWO_SIDED|95.0|2.65|18.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||18.71|2.65|<0.0001
71750342|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.51||||0.007|TWO_SIDED|95.0|1.41|8.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.76|1.41|0.0070
71750343|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0193|TWO_SIDED|95.0|1.2|8.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.23|1.20|0.0193
71782628|NCT03982368|143064618|SUPERIORITY||Least square mean difference|0.28||||0.217|TWO_SIDED|95.0|-0.51|1.07|||ANOVA|||||1.07|-0.51|0.217
71782629|NCT03982368|143064619|SUPERIORITY||Least square mean difference|0.92||||0.007|TWO_SIDED|95.0|0.1|1.74|||ANOVA|||||1.74|0.10|0.007
71782630|NCT03982368|143064619|SUPERIORITY||Least square mean difference|0.28||||0.225|TWO_SIDED|95.0|-0.54|1.1|||ANOVA|||||1.10|-0.54|0.225
71782631|NCT03982368|143064620|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.680
71782632|NCT03982368|143064620|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||0.066
71668574|NCT02189837|142853545|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|-65.91|-48.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-48.38|-65.91|<0.001
71668575|NCT02189837|142853545|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.95|STANDARD_ERROR_OF_MEAN|4.31|<|0.001|TWO_SIDED|95.0|-46.55|-29.34|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-29.34|-46.55|<0.001
71668576|NCT02189837|142853545|SUPERIORITY_OR_OTHER||Treatment Effect|19.2|STANDARD_ERROR_OF_MEAN|6.15||0.003|TWO_SIDED|95.0|6.93|31.47|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||31.47|6.93|0.003
71668577|NCT02189837|142853546|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.65|STANDARD_ERROR_OF_MEAN|10.41||0.11|TWO_SIDED|95.0|-37.37|4.08|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||4.08|-37.37|0.11
71668578|NCT02189837|142853546|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-32.66|STANDARD_ERROR_OF_MEAN|10.31||0.002|TWO_SIDED|95.0|-53.19|-12.13|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-12.13|-53.19|0.002
71668579|NCT02189837|142853546|SUPERIORITY_OR_OTHER||Treatment Effect|-16.01|STANDARD_ERROR_OF_MEAN|14.65||0.28|TWO_SIDED|95.0|-45.18|13.16|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||13.16|-45.18|0.28
71750344|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.34||||0.0148|TWO_SIDED|95.0|1.27|8.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.81|1.27|0.0148
71668580|NCT02189837|142853547|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-2.12|STANDARD_ERROR_OF_MEAN|13.4||0.87|TWO_SIDED|95.0|-28.94|24.7|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.||24.70|-28.94|0.87
71668581|NCT02189837|142853547|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|39.06|STANDARD_ERROR_OF_MEAN|12.76||0.003|TWO_SIDED|95.0|13.52|64.59|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.||64.59|13.52|0.003
71668582|NCT02189837|142853547|SUPERIORITY_OR_OTHER||Treatment Effect|41.18|STANDARD_ERROR_OF_MEAN|18.5||0.03|TWO_SIDED|95.0|4.15|78.2|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.||78.20|4.15|0.030
71782633|NCT03982368|143064621|SUPERIORITY|||||||0.097|||||||Chi-squared|||||||0.097
71668583|NCT02189837|142853548|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.43|STANDARD_ERROR_OF_MEAN|11.6||0.001|TWO_SIDED|95.0|-62.66|-16.21|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||-16.21|-62.66|0.001
71668584|NCT02189837|142853548|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|23.28|STANDARD_ERROR_OF_MEAN|11.05||0.039|TWO_SIDED|95.0|1.16|45.4|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||45.40|1.16|0.039
71668585|NCT02189837|142853548|SUPERIORITY_OR_OTHER||Treatment Effect|62.72|STANDARD_ERROR_OF_MEAN|16.02|<|0.001|TWO_SIDED|95.0|30.65|94.79|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||||94.79|30.65|<0.001
71750345|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0018|TWO_SIDED|95.0|1.83|13.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||13.94|1.83|0.0018
71750346|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|7.27||||0.0007|TWO_SIDED|95.0|2.32|22.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||22.78|2.32|0.0007
71782634|NCT03982368|143064621|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
71782635|NCT03982368|143064622|SUPERIORITY||Least square mean difference|16.4||||0.289|TWO_SIDED|95.0|12.0|20.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||20.8|12.0|0.289
71782636|NCT03982368|143064622|SUPERIORITY||Least square mean difference|19.7||||0.032|TWO_SIDED|95.0|15.4|24.0|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.0|15.4|0.032
71782637|NCT03982368|143064622|SUPERIORITY||Least square mean difference|16.4||||0.095|TWO_SIDED|95.0|11.9|20.8|||ANOVA|||Daily Activity Limitations - change to baseline to week 8||20.8|11.9|0.095
71782638|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.5||||0.282|TWO_SIDED|95.0|10.1|18.8|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||18.8|10.1|0.282
71668586|NCT00619060|142853555|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||Binomial|||||||0.01
71677081|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-24.81|-15.64||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.64|-24.81|<0.0001
71750347|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0246|TWO_SIDED|95.0|1.16|8.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.35|1.16|0.0246
71750348|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0016|TWO_SIDED|95.0|1.87|14.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||14.60|1.87|0.0016
71750349|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.25||||0.0825|TWO_SIDED|95.0|0.9|5.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||5.62|0.90|0.0825
71750350|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.66||||0.0542|TWO_SIDED|95.0|0.98|7.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.20|0.98|0.0542
71750351|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0837|TWO_SIDED|95.0|0.89|6.33||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.33|0.89|0.0837
71750352|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.67||||0.0131|TWO_SIDED|95.0|1.31|10.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.26|1.31|0.0131
71750353|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|9.34||||0.0012|TWO_SIDED|95.0|2.41|36.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||36.19|2.41|0.0012
71750354|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0359|TWO_SIDED|95.0|1.08|8.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.93|1.08|0.0359
71750355|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|5.86||||0.0019|TWO_SIDED|95.0|1.91|17.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||17.92|1.91|0.0019
71750356|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0715|TWO_SIDED|95.0|0.93|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|0.93|0.0715
71750357|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0465|TWO_SIDED|95.0|1.02|8.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||8.20|1.02|0.0465
71750358|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0839|TWO_SIDED|95.0|0.89|6.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.53|0.89|0.0839
71750359|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.56||||0.0191|TWO_SIDED|95.0|1.23|10.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.28|1.23|0.0191
71750360|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|12.11||||0.0019|TWO_SIDED|95.0|2.52|58.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||58.22|2.52|0.0019
71750361|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0593|TWO_SIDED|95.0|0.96|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.90|0.96|0.0593
71750362|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|4.95||||0.0048|TWO_SIDED|95.0|1.63|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||15.04|1.63|0.0048
71750363|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0494|TWO_SIDED|95.0|1.0|7.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.57|1.00|0.0494
71750364|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.15||||0.1887|TWO_SIDED|95.0|0.69|6.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.70|0.69|0.1887
71782639|NCT03982368|143064622|SUPERIORITY||Least square mean difference|15.0||||0.169|TWO_SIDED|95.0|10.6|19.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.4|10.6|0.169
71750365|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.06||||0.0717|TWO_SIDED|95.0|0.91|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||10.7|0.91|0.0717
71750366|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.43||||0.1419|TWO_SIDED|95.0|0.74|7.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.92|0.74|0.1419
71750367|NCT03192176|143005314|SUPERIORITY|0.0141|Odds Ratio (OR)|14.37||||0.0141|TWO_SIDED|95.0|1.71|120.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||120.6|1.71|0.0141
71750368|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0775|TWO_SIDED|95.0|0.88|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.54|0.88|0.0775
71750369|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0283|TWO_SIDED|95.0|1.17|16.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||16.19|1.17|0.0283
71750370|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1767|TWO_SIDED|95.0|0.7|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.96|0.70|0.1767
71750371|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.2||||0.1675|TWO_SIDED|95.0|0.72|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.72|0.72|0.1675
71750372|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.84||||0.2717|TWO_SIDED|95.0|0.62|5.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.49|0.62|0.2717
71750373|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.4||||0.1367|TWO_SIDED|95.0|0.76|7.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.64|0.76|0.1367
71750374|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|13.53||||0.0162|TWO_SIDED|95.0|1.62|113.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||113.0|1.62|0.0162
71750375|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.23||||0.0765|TWO_SIDED|95.0|0.88|11.78||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||11.78|0.88|0.0765
71750376|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|7.8||||0.0061|TWO_SIDED|95.0|1.79|33.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||33.87|1.79|0.0061
71750377|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0181|TWO_SIDED|95.0|1.33|21.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||21.85|1.33|0.0181
71750378|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.63||||0.3925|TWO_SIDED|95.0|0.53|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||4.99|0.53|0.3925
71750379|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.66||||0.374|TWO_SIDED|95.0|0.54|5.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||5.12|0.54|0.3740
71782640|NCT03982368|143064622|SUPERIORITY||Least square mean difference|15.4||||0.129|TWO_SIDED|95.0|11.1|19.7|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||19.7|11.1|0.129
71782641|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.0||||0.111|TWO_SIDED|95.0|9.7|18.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.4|9.7|0.111
71782642|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.0||||0.107|TWO_SIDED|95.0|9.7|18.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.3|9.7|0.107
71782643|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.3||||0.827|TWO_SIDED|95.0|9.7|18.9|||ANOVA|||Emotional Well-Being - change from baseline to week 4||18.9|9.7|0.827
71782644|NCT03982368|143064622|SUPERIORITY||Least square mean difference|16.3||||0.688|TWO_SIDED|95.0|11.8|20.8|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.8|11.8|0.688
71782645|NCT03982368|143064622|SUPERIORITY||Least square mean difference|15.7||||0.324|TWO_SIDED|95.0|11.4|20.0|||ANOVA|||Emotional Well-Being - change from baseline to week 8||20.0|11.4|0.324
71782646|NCT03982368|143064622|SUPERIORITY||Least square mean difference|12.9||||0.949|TWO_SIDED|95.0|8.7|17.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||17.1|8.7|0.949
71750380|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1753|TWO_SIDED|95.0|0.69|7.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.93|0.69|0.1753
71782647|NCT03982368|143064622|SUPERIORITY||Least square mean difference|15.7||||0.927|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.1|11.4|0.927
71835735|NCT03580369|143176664|SUPERIORITY||LS Mean|-7.964|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-10.522|-5.047|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||-5.047|-10.522|<.0001
71835736|NCT03580369|143176664|SUPERIORITY||LS mean|0.71|STANDARD_ERROR_OF_MEAN|0.933||0.7768|TWO_SIDED|95.0|-1.118|2.538|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults||2.538|-1.118|0.7768
71835737|NCT03580369|143176666|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.68|||<|0.0001|TWO_SIDED|95.0|2.667|12.095|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.095|2.667|<.0001
71835738|NCT03580369|143176666|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.84||||0.843|TWO_SIDED|95.0|0.598|1.18|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.180|0.598|0.8430
71750381|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|12.85||||0.0195|TWO_SIDED|95.0|1.51|109.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||109.5|1.51|0.0195
71782648|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.8||||0.776|TWO_SIDED|95.0|10.8|18.8|||ANOVA|||Emotional Well-Being - change from baseline to week 12||18.8|10.8|0.776
71782649|NCT03982368|143064622|SUPERIORITY||Least square mean difference|15.7||||0.418|TWO_SIDED|95.0|11.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.1|11.4|0.418
71782650|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.8||||0.613|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||19.0|10.6|0.613
71782651|NCT03982368|143064622|SUPERIORITY||Least square mean difference|15.8||||0.721|TWO_SIDED|95.0|8.3|23.2|||ANOVA|||Work Limitations - change from baseline to week 4||23.2|8.3|0.721
71782652|NCT03982368|143064622|SUPERIORITY||Least square mean difference|20.6||||0.558|TWO_SIDED|95.0|13.1|28.0|||ANOVA|||Work Limitations - change from baseline to week 4||28.0|13.1|0.558
71782653|NCT03982368|143064622|SUPERIORITY||Least square mean difference|18.4||||0.809|TWO_SIDED|95.0|11.5|25.3|||ANOVA|||Work Limitations - change from baseline to week 8||25.3|11.5|0.809
71782654|NCT03982368|143064622|SUPERIORITY||Least square mean difference|19.4||||0.651|TWO_SIDED|95.0|12.4|26.4|||ANOVA|||Work Limitations - change from baseline to week 8||26.4|12.4|0.651
71782655|NCT03982368|143064622|SUPERIORITY||Least square mean difference|16.4||||0.769|TWO_SIDED|95.0|9.5|23.3|||ANOVA|||Work Limitations - change from baseline to week 12||23.3|9.5|0.769
71782656|NCT03982368|143064622|SUPERIORITY||Least square mean difference|21.3||||0.454|TWO_SIDED|95.0|14.3|28.3|||ANOVA|||Work Limitations - change from baseline to week 12||28.3|14.3|0.454
71782657|NCT03982368|143064622|SUPERIORITY||Least square mean difference|18.3||||0.564|TWO_SIDED|95.0|11.6|25.0|||ANOVA|||Work Limitations - change from baseline to week 16||25.0|11.6|0.564
71782658|NCT03982368|143064622|SUPERIORITY||Least square mean difference|21.0||||0.25|TWO_SIDED|95.0|14.1|27.8|||ANOVA|||Work Limitations - change from baseline to week 16||27.8|14.1|0.250
71782659|NCT03982368|143064622|SUPERIORITY||Least square mean difference|23.9||||0.853|TWO_SIDED|95.0|15.6|32.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||32.2|15.6|0.853
71782660|NCT03982368|143064622|SUPERIORITY||Least square mean difference|20.0||||0.393|TWO_SIDED|95.0|11.9|28.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||28.0|11.9|0.393
71782661|NCT03982368|143064622|SUPERIORITY||Least square mean difference|27.9||||0.01|TWO_SIDED|95.0|20.2|35.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||35.6|20.2|0.010
71782662|NCT03982368|143064622|SUPERIORITY||Least square mean difference|18.3||||0.395|TWO_SIDED|95.0|11.1|25.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||25.4|11.1|0.395
71782663|NCT03982368|143064622|SUPERIORITY||Least square mean difference|24.8||||0.068|TWO_SIDED|95.0|17.1|32.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||32.4|17.1|0.068
71782664|NCT03982368|143064622|SUPERIORITY||Least square mean difference|19.3||||0.4|TWO_SIDED|95.0|12.2|26.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||26.4|12.2|0.400
71782665|NCT03982368|143064622|SUPERIORITY||Least square mean difference|25.5||||0.021|TWO_SIDED|95.0|18.1|33.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.0|18.1|0.021
71782666|NCT03982368|143064622|SUPERIORITY||Least square mean difference|23.1||||0.056|TWO_SIDED|95.0|16.1|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||30.0|16.1|0.056
71782667|NCT03982368|143064622|SUPERIORITY||Least square mean difference|14.2||||0.981|TWO_SIDED|95.0|7.6|20.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||20.7|7.6|0.981
71782668|NCT03982368|143064622|SUPERIORITY||Least square mean difference|17.0||||0.525|TWO_SIDED|95.0|11.1|22.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.9|11.1|0.525
71782669|NCT03982368|143064622|SUPERIORITY||Least square mean difference|9.5||||0.356|TWO_SIDED|95.0|2.9|16.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||16.0|2.9|0.356
71782670|NCT03982368|143064622|SUPERIORITY||Least square mean difference|6.5||||0.771|TWO_SIDED|95.0|0.7|12.4|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||12.4|0.7|0.771
71750382|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1932|TWO_SIDED|95.0|0.66|8.02||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.02|0.66|0.1932
71750383|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.55||||0.0537|TWO_SIDED|95.0|0.98|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||12.86|0.98|0.0537
71750384|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|7.72||||0.0144|TWO_SIDED|95.0|1.5|39.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||39.66|1.50|0.0144
71750385|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.29||||0.666|TWO_SIDED|95.0|0.41|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.09|0.41|0.6660
71750386|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.16||||0.7923|TWO_SIDED|95.0|0.37|3.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.62|0.37|0.7923
71750387|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.73||||0.3796|TWO_SIDED|95.0|0.51|5.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.90|0.51|0.3796
71750388|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0874|TWO_SIDED|95.0|0.81|21.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||21.73|0.81|0.0874
71750389|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1925|TWO_SIDED|95.0|0.62|10.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||10.96|0.62|0.1925
71750390|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.99||||0.0651|TWO_SIDED|95.0|0.92|17.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.38|0.92|0.0651
71750391|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5361|TWO_SIDED|95.0|0.44|4.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.81|0.44|0.5361
71750392|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6258|TWO_SIDED|95.0|0.42|4.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.17|0.42|0.6258
71750393|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.32||||0.6275|TWO_SIDED|95.0|0.43|4.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.06|0.43|0.6275
71750394|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2212|TWO_SIDED|95.0|0.62|7.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.90|0.62|0.2212
71750395|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|11.13||||0.028|TWO_SIDED|95.0|1.3|95.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||95.49|1.30|0.0280
71750396|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|4.88||||0.0589|TWO_SIDED|95.0|0.94|25.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||25.32|0.94|0.0589
71750397|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.63||||0.0799|TWO_SIDED|95.0|0.86|15.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||15.39|0.86|0.0799
71750398|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1112|TWO_SIDED|95.0|0.78|10.87||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.87|0.78|0.1112
71782671|NCT03982368|143064622|SUPERIORITY||Least square mean difference|8.7||||0.926|TWO_SIDED|95.0|2.0|15.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.5|2.0|0.926
71782672|NCT03982368|143064622|SUPERIORITY||Least square mean difference|7.9||||0.778|TWO_SIDED|95.0|1.9|13.9|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||13.9|1.9|0.778
71782673|NCT03982368|143064622|SUPERIORITY||Least square mean difference|10.0||||0.984|TWO_SIDED||||||ANOVA|||Treatment-Related Bother - change from baseline to week 16||||0.984
71782674|NCT03982368|143064622|SUPERIORITY||Least square mean difference|7.4||||0.514|TWO_SIDED|95.0|1.6|13.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||13.1|1.6|0.514
71835739|NCT03580369|143176666|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|5.734|||<|0.0001|TWO_SIDED|95.0|2.694|12.207|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||12.207|2.694|<.0001
71835740|NCT03580369|143176666|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|0.848||||0.8312|TWO_SIDED|95.0|0.605|1.188|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.188|0.605|0.8312
71835741|NCT03580369|143176667|SUPERIORITY||LS Mean|-3.1|STANDARD_ERROR_OF_MEAN|0.597|<|0.0001|TWO_SIDED|95.0|-4.271|-1.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||-1.929|-4.271|<.0001
71835742|NCT03580369|143176667|SUPERIORITY||LS Mean|0.419|STANDARD_ERROR_OF_MEAN|0.428||0.8366|TWO_SIDED|95.0|-0.419|1.258|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.258|-0.419|0.8366
71750399|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0959|TWO_SIDED|95.0|0.84|9.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.11|0.84|0.0959
71750400|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.62||||0.3886|TWO_SIDED|95.0|0.54|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||4.85|0.54|0.3886
71750401|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0864|TWO_SIDED|95.0|0.85|10.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.52|0.85|0.0864
71750402|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|14.22||||0.0145|TWO_SIDED|95.0|1.69|119.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||119.5|1.69|0.0145
71782675|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-16.6||||0.985|TWO_SIDED|95.0|-20.4|-12.8|||ANOVA|||Symptom Bother - change from baseline to week 4||-12.8|-20.4|0.985
71782676|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-17.8||||0.646|TWO_SIDED|95.0|-21.5|-14.0|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.0|-21.5|0.646
71835743|NCT03580369|143176667|SUPERIORITY|Adults|LS Mean|-3.13|STANDARD_ERROR_OF_MEAN|0.594|<|0.0001|TWO_SIDED|95.0|-4.295|-1.966|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-1.966|-4.295|<.0001
71835744|NCT03580369|143176667|SUPERIORITY||LS Mean|0.389|STANDARD_ERROR_OF_MEAN|0.425||0.8201|TWO_SIDED|95.0|-0.444|1.222|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults||1.222|-0.444|0.8201
71835745|NCT03580369|143176669|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|2.747|||<|0.0001|TWO_SIDED|95.0|1.621|4.656|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||4.656|1.621|<.0001
71782677|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-20.7||||0.007|TWO_SIDED|95.0|-24.5|-16.9|||ANOVA|||Symptom Bother - change from baseline to week 8||-16.9|-24.5|0.007
71782678|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-16.2||||0.305|TWO_SIDED|95.0|-19.9|-12.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-12.5|-19.9|0.305
71835746|NCT03580369|143176669|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.836||||0.8586|TWO_SIDED|95.0|0.603|1.159|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.159|0.603|0.8586
71835747|NCT03580369|143176669|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.261|||<|0.0001|TWO_SIDED|95.0|1.929|5.513|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||5.513|1.929|<.0001
71835748|NCT03580369|143176669|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.992||||0.519|TWO_SIDED|95.0|0.717|1.373|||Regression, Logistic|95% confidence interval for the odds ratio||Adults||1.373|0.717|0.5190
71835749|NCT03580369|143176670|SUPERIORITY||Risk Ratio (RR)|1.323|||<|0.0001|TWO_SIDED|95.0|1.183|1.48|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.480|1.183|<.0001
71835750|NCT03580369|143176670|SUPERIORITY||Risk Ratio (RR)|0.975||||0.7469|TWO_SIDED|95.0|0.904|1.051|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.051|0.904|0.7469
71750403|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|13.08||||0.018|TWO_SIDED|95.0|1.56|110.0||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||110.0|1.56|0.0180
71782679|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-19.0||||0.015|TWO_SIDED|95.0|-22.7|-15.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.4|-22.7|0.015
71782680|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-18.0||||0.039|TWO_SIDED|95.0|-21.5|-14.4|||ANOVA|||Symptom Bother - change from baseline to week 12||-14.4|-21.5|0.039
71782681|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-19.7||||0.001|TWO_SIDED|95.0|-23.3|-16.0|||ANOVA|||||-16.0|-23.3|0.001
71835751|NCT03580369|143176670|SUPERIORITY||Risk Ratio (RR)|1.376|||<|0.0001|TWO_SIDED|95.0|1.23|1.54|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.540|1.230|<.0001
71835752|NCT03580369|143176670|SUPERIORITY||Risk Ratio (RR)|1.014||||0.3586|TWO_SIDED|95.0|0.941|1.092|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults||1.092|0.941|0.3586
71835753|NCT04455035|143176741|OTHER|ttest||||||0.0088|||||||t-test, 2 sided|||||||0.0088
71835754|NCT04455035|143176742|OTHER|ttest||||||1e-05|||||||t-test, 2 sided|||||||0.00001
71891666|NCT05817045|143304665|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.33||||0.014|TWO_SIDED|95.0|1.059|1.665|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19;|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (Per-Protocol population)||1.665|1.059|0.014
71750404|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|18.53||||0.008|TWO_SIDED|95.0|2.14|160.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||160.6|2.14|0.0080
71750405|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|5.07||||0.0236|TWO_SIDED|95.0|1.24|20.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||20.65|1.24|0.0236
71782682|NCT03982368|143064622|SUPERIORITY||Least square mean difference|-18.9||||0.002|TWO_SIDED|95.0|-22.4|-15.3|||ANOVA|||Symptom Bother - change from baseline to week 16||-15.3|-22.4|0.002
71782683|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.8||||0.241|TWO_SIDED|95.0|12.2|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||21.4|12.2|0.241
71782684|NCT03982368|143064623|SUPERIORITY||Least square mean difference|19.7||||0.04|TWO_SIDED|95.0|15.1|24.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 4||24.4|15.1|0.040
71782685|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.8||||0.097|TWO_SIDED|95.0|12.3|21.4|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||21.4|12.3|0.097
71782686|NCT03982368|143064623|SUPERIORITY||Least square mean difference|15.3||||0.238|TWO_SIDED|95.0|10.7|19.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 8||19.9|10.7|0.238
71782687|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.5||||0.07|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||20.9|12.0|0.070
71782688|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.7||||0.058|TWO_SIDED|95.0|12.3|21.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 12||21.1|12.3|0.058
71782689|NCT03982368|143064623|SUPERIORITY||Least square mean difference|13.7||||0.128|TWO_SIDED|95.0|9.3|18.1|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||18.1|9.3|0.128
71782690|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.0||||0.024|TWO_SIDED|95.0|11.6|20.3|||ANOVA|||Daily Activity Limitations - change from baseline to week 16||20.3|11.6|0.024
71782691|NCT03982368|143064623|SUPERIORITY||Least square mean difference|15.2||||0.865|TWO_SIDED|95.0|10.4|20.1|||ANOVA|||Emotional Well-Being - change from baseline to week 4||20.1|10.4|0.865
71782692|NCT03982368|143064623|SUPERIORITY||Least square mean difference|17.3||||0.662|TWO_SIDED|95.0|12.4|22.2|||ANOVA|||Emotional Well-Being - change from baseline to week 4||22.2|12.4|0.662
71782693|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.7||||0.266|TWO_SIDED|95.0|12.2|21.1|||ANOVA|||Emotional Well-Being - change from baseline to week 8||21.1|12.2|0.266
71782694|NCT03982368|143064623|SUPERIORITY||Least square mean difference|13.9||||0.824|TWO_SIDED|95.0|9.4|18.3|||ANOVA|||Emotional Well-Being - change from baseline to week 8||18.3|9.4|0.824
71782695|NCT03982368|143064623|SUPERIORITY||Least square mean difference|14.8||||0.883|TWO_SIDED|95.0|10.6|19.0|||ANOVA|||Emotional Well-Being - change from baseline to week 12||19.0|10.6|0.883
71782696|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.3||||0.516|TWO_SIDED|95.0|12.1|20.4|||ANOVA|||Emotional Well-Being - change from baseline to week 12||20.4|12.1|0.516
71782697|NCT03982368|143064623|SUPERIORITY|Emotional Well-Being - change from baseline to week 16|Least square mean difference|16.5||||0.407|TWO_SIDED|95.0|12.1|21.0|||ANOVA|||Emotional Well-Being - change from baseline to week 16||21.0|12.1|0.407
71782698|NCT03982368|143064623|SUPERIORITY||Least square mean difference|16.4||||0.422|TWO_SIDED|95.0|12.0|20.9|||ANOVA|||Emotional Well-Being - change from baseline to week 16||20.9|12.0|0.422
71782699|NCT03982368|143064623|SUPERIORITY||Least square mean difference|15.9||||0.615|TWO_SIDED|95.0|8.1|23.8|||ANOVA|||Work Limitations - change from baseline to week 4||23.8|8.1|0.615
71782700|NCT03982368|143064623|SUPERIORITY||Least square mean difference|21.3||||0.626|TWO_SIDED|95.0|13.3|29.2|||ANOVA|||Work Limitations - change from baseline to week 4||29.2|13.3|0.626
71782701|NCT03982368|143064623|SUPERIORITY||Least square mean difference|18.3||||0.968|TWO_SIDED|95.0|11.1|25.6|||ANOVA|||Work Limitations - change from baseline to week 8||25.6|11.1|0.968
71782702|NCT03982368|143064623|SUPERIORITY||Least square mean difference|20.1||||0.689|TWO_SIDED|95.0|12.8|27.4|||ANOVA|||||27.4|12.8|0.689
71782703|NCT03982368|143064623|SUPERIORITY||Least square mean difference|15.6||||0.528|TWO_SIDED|95.0|8.5|22.7|||ANOVA|||Work Limitations - change from baseline to week 12||22.7|8.5|0.528
71782704|NCT03982368|143064623|SUPERIORITY||Least square mean difference|23.0||||0.368|TWO_SIDED|95.0|15.8|30.1|||ANOVA|||Work Limitations - change from baseline to week 12||30.1|15.8|0.368
71782705|NCT03982368|143064623|SUPERIORITY||Least square mean difference|17.7||||0.764|TWO_SIDED|95.0|10.7|24.7|||ANOVA|||Work Limitations - change from baseline to week 16||24.7|10.7|0.764
71782706|NCT03982368|143064623|SUPERIORITY||Least square mean difference|22.6||||0.184|TWO_SIDED|95.0|15.5|29.6|||ANOVA|||Work Limitations - change from baseline to week 16||29.6|15.5|0.184
71782707|NCT03982368|143064623|SUPERIORITY||Least square mean difference|25.4||||0.909|TWO_SIDED|95.0|16.5|34.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||34.2|16.5|0.909
71782708|NCT03982368|143064623|SUPERIORITY||Least square mean difference|21.1||||0.428|TWO_SIDED|95.0|12.2|30.0|||ANOVA|||Treatment Satisfaction - change from baseline to week 4||30.0|12.2|0.428
71750406|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4303|TWO_SIDED|0.4303|0.5|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||5.07|0.50|0.4303
71782709|NCT03982368|143064623|SUPERIORITY||Least square mean difference|29.8||||0.008|TWO_SIDED|95.0|21.6|37.9|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||37.9|21.6|0.008
71782710|NCT03982368|143064623|SUPERIORITY||Least square mean difference|21.3||||0.222|TWO_SIDED|95.0|13.5|29.2|||ANOVA|||Treatment Satisfaction - change from baseline to week 8||29.2|13.5|0.222
71782711|NCT03982368|143064623|SUPERIORITY||Least square mean difference|25.3||||0.082|TWO_SIDED|95.0|17.2|33.4|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||33.4|17.2|0.082
71782712|NCT03982368|143064623|SUPERIORITY||Least square mean difference|23.3||||0.154|TWO_SIDED|95.0|15.6|31.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 12||31.1|15.6|0.154
71782713|NCT03982368|143064623|SUPERIORITY||Least square mean difference|25.8||||0.03|TWO_SIDED|95.0|18.0|33.6|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||33.6|18.0|0.030
71782714|NCT03982368|143064623|SUPERIORITY||Least square mean difference|24.6||||0.046|TWO_SIDED|95.0|17.1|32.1|||ANOVA|||Treatment Satisfaction - change from baseline to week 16||32.1|17.1|0.046
71782715|NCT03982368|143064623|SUPERIORITY||Least square mean difference|15.4||||0.861|TWO_SIDED|95.0|8.6|22.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||22.2|8.6|0.861
71750407|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.41||||0.5529|TWO_SIDED|95.0|0.45|4.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.39|0.45|0.5529
71750408|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3268|TWO_SIDED|95.0|0.53|6.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.55|0.53|0.3268
71750409|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|10.02||||0.0343|TWO_SIDED|95.0|1.19|84.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||84.66|1.19|0.0343
71750410|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|9.45||||0.0391|TWO_SIDED|95.0|1.12|79.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||79.82|1.12|0.0391
71750411|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|13.31||||0.0187|TWO_SIDED|95.0|1.54|115.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||115.1|1.54|0.0187
71750412|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.6||||0.1475|TWO_SIDED|95.0|0.71|9.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.47|0.71|0.1475
71750413|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2161|TWO_SIDED|95.0|0.63|7.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||7.55|0.63|0.2161
71750414|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.79||||0.3478|TWO_SIDED|95.0|0.53|6.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.04|0.53|0.3478
71782716|NCT03982368|143064623|SUPERIORITY||Least square mean difference|15.3||||0.865|TWO_SIDED|95.0|9.0|21.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 4||21.7|9.0|0.865
71782717|NCT03982368|143064623|SUPERIORITY||Least square mean difference|10.5||||0.278|TWO_SIDED|95.0|3.6|17.3|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||17.3|3.6|0.278
71782718|NCT03982368|143064623|SUPERIORITY||Least square mean difference|7.2||||0.689|TWO_SIDED|95.0|0.9|13.5|||ANOVA|||Treatment-Related Bother - change from baseline to week 8||13.5|0.9|0.689
71782719|NCT03982368|143064623|SUPERIORITY||Least square mean difference|9.1||||0.993|TWO_SIDED|95.0|2.1|16.2|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||16.2|2.1|0.993
71782720|NCT03982368|143064623|SUPERIORITY||Least square mean difference|9.2||||0.989|TWO_SIDED|95.0|2.8|15.7|||ANOVA|||Treatment-Related Bother - change from baseline to week 12||15.7|2.8|0.989
71782721|NCT03982368|143064623|SUPERIORITY||Least square mean difference|10.4||||0.976|TWO_SIDED|95.0|3.7|17.0|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||17.0|3.7|0.976
71782722|NCT03982368|143064623|SUPERIORITY||Least square mean difference|9.0||||0.778|TWO_SIDED|95.0|2.9|15.1|||ANOVA|||Treatment-Related Bother - change from baseline to week 16||15.1|2.9|0.778
71782723|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-17.3||||0.964|TWO_SIDED|95.0|-21.2|-13.3|||ANOVA|||Symptom Bother - change from baseline to week 4||-13.3|-21.2|0.964
71782724|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-18.7||||0.581|TWO_SIDED|95.0|-22.7|-14.7|||ANOVA|||Symptom Bother - change from baseline to week 4||-14.7|-22.7|0.581
71835755|NCT04970407|143176778|SUPERIORITY||Treatment difference|-1.16||||0.8769|TWO_SIDED|95.0|-16.25|13.93|||MMRM model|||The adjusted mean, standard error (SE) and 95% confidence interval (CI) of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||13.93|-16.25|0.8769
71750415|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.22||||0.2269|TWO_SIDED|95.0|0.61|8.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.14|0.61|0.2269
71750416|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|4.66||||0.0683|TWO_SIDED|95.0|0.89|24.35||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||24.35|0.89|0.0683
71750417|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|7.11||||0.0228|TWO_SIDED|95.0|1.31|38.49||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||38.49|1.31|0.0228
71782725|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-21.4||||0.006|TWO_SIDED|95.0|-25.2|-17.5|||ANOVA|||Symptom Bother - change from baseline to week 8||-17.5|-25.2|0.006
71782726|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-17.6||||0.175|TWO_SIDED|95.0|-21.4|-13.7|||ANOVA|||Symptom Bother - change from baseline to week 8||-13.7|-21.4|0.175
71782727|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-19.4||||0.016|TWO_SIDED|95.0|-23.1|-15.6|||ANOVA|||Symptom Bother - change from baseline to week 12||-15.6|-23.1|0.016
71782728|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-19.8||||0.01|TWO_SIDED|95.0|-23.5|-16.1|||ANOVA|||Symptom Bother - change from baseline to week 12||-16.1|-23.5|0.010
71782729|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-20.5||||0|TWO_SIDED|95.0|-24.3|-16.8|||ANOVA|||Symptom Bother - change from baseline to week 16||-16.8|-24.3|0.000
71782730|NCT03982368|143064623|SUPERIORITY||Least square mean difference|-20.8||||0|TWO_SIDED|95.0|-24.6|-17.1|||ANOVA|||Symptom Bother - change from baseline to week 16||-17.1|-24.6|0.000
71782731|NCT03982368|143064624|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.302
71782732|NCT03982368|143064624|SUPERIORITY|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.224
71782733|NCT03982368|143064624|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.000
71782734|NCT03982368|143064624|SUPERIORITY|||||||0.885|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.885
71782735|NCT03982368|143064624|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.035
71782736|NCT03982368|143064624|SUPERIORITY|||||||0.698|||||||Wilcoxon (Mann-Whitney)|||At week 12 (FUP)||||0.698
71782737|NCT03982368|143064624|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.016
71782738|NCT03982368|143064624|SUPERIORITY|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||At week 16 (FUP)||||0.706
71782739|NCT03982368|143064625|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||at week 4||||0.210
71782740|NCT03982368|143064625|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||at weeek 4||||0.260
71782741|NCT03982368|143064625|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||At week 8 (FUP)||||0.000
71782742|NCT03982368|143064625|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||at week 8 (FUP)||||0.734
71782743|NCT03982368|143064625|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.050
71782744|NCT03982368|143064625|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||at week 12 (FUP)||||0.985
71782745|NCT03982368|143064625|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.018
71782746|NCT03982368|143064625|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||at week 16 (FUP)||||0.580
71782747|NCT03982368|143064626|SUPERIORITY||Least square mean difference|1.2||||0.282|TWO_SIDED|95.0|-1.0|3.3|||ANOVA|||statistical analysis at week 4||3.3|-1.0|0.282
71782748|NCT03982368|143064626|SUPERIORITY||Least square mean difference|3.9||||0.497|TWO_SIDED|95.0|1.7|6.0|||ANOVA|||statistical analysis at week 4||6.0|1.7|0.497
71782749|NCT03982368|143064626|SUPERIORITY||Least square mean difference|2.6||||0.734|TWO_SIDED|95.0|0.5|4.8|||ANOVA|||statistical analysis at week 8||4.8|0.5|0.734
71782750|NCT03982368|143064626|SUPERIORITY||Least square mean difference|2.2||||0.963|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||statistical analysis at week 8||4.3|0.1|0.963
71782751|NCT03982368|143064626|SUPERIORITY||Least square mean difference|2.7||||0.854|TWO_SIDED|95.0|0.7|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.7|0.854
71782752|NCT03982368|143064626|SUPERIORITY||Least square mean difference|2.8||||0.881|TWO_SIDED|95.0|0.8|4.8|||ANOVA|||statistical analysis at week 12||4.8|0.8|0.881
71782753|NCT03982368|143064626|SUPERIORITY||Least square mean difference|3.0||||0.632|TWO_SIDED|95.0|0.3|5.7|||ANOVA|||statistical analysis at week 16||5.7|0.3|0.632
71782754|NCT03982368|143064626|SUPERIORITY||Least square mean difference|4.4||||0.22|TWO_SIDED|95.0|1.7|7.0|||ANOVA|||statistical analysis at week 16||7.0|1.7|0.220
71782755|NCT03982368|143064627|SUPERIORITY||Least square mean difference|1.2||||0.296|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|||statistical analysis at week 4||3.3|-0.9|0.296
71782756|NCT03982368|143064627|SUPERIORITY||Least square mean difference|3.6||||0.57|TWO_SIDED|95.0|1.5|5.7|||ANOVA|||statistical analysis at week 4||5.7|1.5|0.570
71782757|NCT03982368|143064627|SUPERIORITY||Least square mean difference|2.7||||0.754|TWO_SIDED|95.0|0.5|4.9|||ANOVA|||statistical analysis at week 8||4.9|0.5|0.754
71782758|NCT03982368|143064627|SUPERIORITY||Least square mean difference|2.3||||0.972|TWO_SIDED|95.0|0.0|4.5|||ANOVA|||statistical analysis at week 8||4.5|0.0|0.972
71750418|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.95||||0.062|TWO_SIDED|95.0|0.93|16.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||16.72|0.93|0.0620
71750419|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.18||||0.2251|TWO_SIDED|95.0|0.62|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.67|0.62|0.2251
71750420|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.18||||0.7908|TWO_SIDED|95.0|0.35|3.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.99|0.35|0.7908
71750421|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3735|TWO_SIDED|95.0|0.48|7.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.06|0.48|0.3735
71750422|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1856|TWO_SIDED|95.0|0.64|9.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.64|0.64|0.1856
71750423|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.67||||0.01798|TWO_SIDED|95.0|0.64|11.2||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.20|0.64|0.01798
71750424|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.19||||0.1101|TWO_SIDED|95.0|0.77|13.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||13.22|0.77|0.1101
71750425|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|2.99||||0.106|TWO_SIDED|95.0|0.79|11.31||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.31|0.79|0.1060
71750426|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.47||||0.5258|TWO_SIDED|95.0|0.45|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.86|0.45|0.5258
71782759|NCT03982368|143064627|SUPERIORITY||Least square mean difference|3.4||||0.793|TWO_SIDED|95.0|1.4|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.4|0.793
71835756|NCT04970407|143176778|SUPERIORITY||Treatment difference|-10.61||||0.162|TWO_SIDED|95.0|-25.69|4.47|||MMRM model|||The adjusted mean, SE and 95% CI of the adjusted mean as well as difference in % relative to baseline and p-value were obtained from a MMRM with Fisher scoring with treatment, time (corresponding to all study visits when CMAP was measured), treatment by time interaction and baseline CMAP amplitude as factors and an unstructured variance covariance matrix.||4.47|-25.69|0.1620
71750427|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.1||||0.8746|TWO_SIDED|95.0|0.34|3.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.50|0.34|0.8746
71750428|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.82||||0.7434|TWO_SIDED|95.0|0.24|2.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.77|0.24|0.7434
71750429|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.9||||0.3211|TWO_SIDED|95.0|0.53|6.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||6.80|0.53|0.3211
71750430|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.51||||0.533|TWO_SIDED|95.0|0.41|5.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.48|0.41|0.5330
71750431|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|3.0||||0.1119|TWO_SIDED|95.0|0.77|11.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||11.64|0.77|0.1119
71750432|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.76||||0.354|TWO_SIDED|95.0|0.53|5.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.85|0.53|0.3540
71782760|NCT03982368|143064627|SUPERIORITY||Least square mean difference|3.4||||0.766|TWO_SIDED|95.0|1.5|5.3|||ANOVA|||statistical analysis at week 12||5.3|1.5|0.766
71782761|NCT03982368|143064627|SUPERIORITY||Least square mean difference|3.3||||0.458|TWO_SIDED|95.0|0.6|6.0|||ANOVA|||statistical analysis at week 16||6.0|0.6|0.458
71782762|NCT03982368|143064627|SUPERIORITY||Least square mean difference|4.6||||0.147|TWO_SIDED|95.0|2.0|7.3|||ANOVA|||statistical analysis at week 16||7.3|2.0|0.147
71677082|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.5||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.50|-17.21|<0.0001
71750433|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.65||||0.5076|TWO_SIDED|95.0|0.19|2.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.29|0.19|0.5076
71782763|NCT00329238|143064628|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Hazard Ratio (HR)|1.44||||0.0137||95.0|0.78|2.64||p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.|Regression, Cox|HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.|HR for time to first recurrent VTE or VTE death.|||2.64|0.78|0.0137
71782764|NCT00329238|143064628|SUPERIORITY_OR_OTHER|||||||0.2424||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.|Regression, Cox|||||||0.2424
71750434|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.71||||0.5801|TWO_SIDED|95.0|0.21|2.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.41|0.21|0.5801
71750435|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.48||||0.2785|TWO_SIDED|95.0|0.13|1.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.82|0.13|0.2785
71750436|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5656|TWO_SIDED|95.0|0.19|2.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.45|0.19|0.5656
71750437|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.73||||0.6445|TWO_SIDED|95.0|0.19|2.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.81|0.19|0.6445
71750438|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|1.27||||0.7363|TWO_SIDED|95.0|0.32|4.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.99|0.32|0.7363
71750439|NCT03192176|143005314|SUPERIORITY||Odds Ratio (OR)|0.56||||0.3455|TWO_SIDED|95.0|0.17|1.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.86|0.17|0.3455
71782765|NCT00329238|143064629|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Risk Difference (RD)|0.38|||<|0.0001||95.0|-0.5|1.25||p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.|Regression, Cox|Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.||||1.25|-0.50|<0.0001
71782766|NCT00329238|143064629|SUPERIORITY_OR_OTHER|||||||0.4013||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.|Kaplan-Meier|||||||0.4013
71750440|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0037|TWO_SIDED|95.0|1.6|11.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||11.54|1.60|0.0037
71750441|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.95||||0.0057|TWO_SIDED|95.0|1.49|10.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||10.48|1.49|0.0057
71750442|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.26|16.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.13|2.26|0.0003
71750443|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|6.42||||0.0003|TWO_SIDED|95.0|2.37|17.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.39|2.37|0.0003
71750444|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.11||||0.141|TWO_SIDED|95.0|0.78|5.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||5.73|0.78|0.1410
71782767|NCT00329238|143064630|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4732||95.0|0.75|1.84|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent VTE or all cause death.|||1.84|0.75|0.4732
71750445|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.85||||0.0004|TWO_SIDED|95.0|2.2|15.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||15.55|2.20|0.0004
71750446|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0006|TWO_SIDED|95.0|2.08|14.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||14.54|2.08|0.0006
71750447|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.09||||0.0037|TWO_SIDED|95.0|1.58|10.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||10.57|1.58|0.0037
71750448|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.31||||0.0026|TWO_SIDED|95.0|1.67|11.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.16|1.67|0.0026
71750449|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|6.26||||0.0002|TWO_SIDED|95.0|2.63|16.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||16.60|2.63|0.0002
71750450|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|9.4|||<|0.0001|TWO_SIDED|95.0|3.23|27.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||27.34|3.23|<0.0001
71750451|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.64||||0.0431|TWO_SIDED|95.0|1.03|6.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.76|1.03|0.0431
71750452|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.72|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||11.29|1.72|0.0020
71750453|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.76||||0.0291|TWO_SIDED|95.0|1.11|6.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||6.86|1.11|0.0291
71835757|NCT06143670|143176804|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
71750454|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.96||||0.0063|TWO_SIDED|95.0|1.48|10.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.61|1.48|0.0063
71750455|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0202|TWO_SIDED|95.0|1.19|8.11||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.11|1.19|0.0202
71750456|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.1||||0.0044|TWO_SIDED|95.0|1.55|10.84||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||10.84|1.55|0.0044
71782768|NCT00329238|143064631|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.09||||0.8876||95.0|-1.11|1.28|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.||Dabigatran versus Warfarin||1.28|-1.11|0.8876
71782769|NCT00329238|143064632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.4548||95.0|0.64|2.71|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent symptomatic DVT|Dabigatran versus Warfarin||2.71|0.64|0.4548
71782770|NCT00329238|143064633|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.19||||0.6563||95.0|-0.63|1.0|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.||Dabigatran versus Warfarin||1.00|-0.63|0.6563
71782771|NCT00329238|143064634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04||||0.1925||95.0|0.7|5.98|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.|Dabigatran versus Warfarin||5.98|0.70|0.1925
71782772|NCT00329238|143064635|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.26||||0.3723||95.0|-0.32|0.84|||Kaplan-Meier||Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18|Dabigatran versus Warfarin||0.84|-0.32|0.3723
71782773|NCT00329238|143064636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9921||95.0|0.06|16.22|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to deaths related to VTE.|Dabigatran versus Warfarin||16.22|0.06|0.9921
71782774|NCT00329238|143064637|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.9204||95.0|-0.2|0.23|||Kaplan-Meier|Risk difference for the time to deaths related to VTE at Month 18.||Dabigatran versus Warfarin||0.23|-0.20|0.9204
71835758|NCT06143670|143176805|SUPERIORITY||Adjusted Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.0001|TWO_SIDED|95.0|-19.6|-14.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-14.1|-19.6|<0.0001
71835759|NCT06143670|143176806|SUPERIORITY||Adjusted Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-18.9|-13.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-13.1|-18.9|<0.0001
71835760|NCT06143670|143176806|SUPERIORITY||Adjusted Mean Difference|-17.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-19.9|-15.3|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-15.3|-19.9|<0.0001
71835761|NCT06143670|143176807|SUPERIORITY||Adjusted Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.35|-0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.20|-0.35|<0.0001
71835762|NCT06143670|143176807|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.26|<0.0001
71835763|NCT06143670|143176807|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.36|-0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.22|-0.36|<0.0001
71750457|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|9.21||||0.0002|TWO_SIDED|95.0|2.89|29.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||29.38|2.89|0.0002
71750458|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0706|TWO_SIDED|95.0|0.93|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.37|0.93|0.0706
71750459|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0001|TWO_SIDED|95.0|2.79|24.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||24.08|2.79|0.0001
71750460|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0146|TWO_SIDED|95.0|1.26|8.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||8.32|1.26|0.0146
71750461|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.37||||0.0816|TWO_SIDED|95.0|0.9|6.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||6.24|0.90|0.0816
71750462|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.25||||0.093|TWO_SIDED|95.0|0.87|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.81|0.87|0.0930
71750463|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.81||||0.365|TWO_SIDED|95.0|1.07|7.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.39|1.07|0.365
71750464|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.93||||0.0042|TWO_SIDED|95.0|1.65|14.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.73|1.65|0.0042
71750465|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.73||||0.0488|TWO_SIDED|95.0|1.01|7.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.41|1.01|0.0488
71750466|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0075|TWO_SIDED|95.0|1.43|10.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.36|1.43|0.0075
71750467|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0984|TWO_SIDED|95.0|0.86|5.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.59|0.86|0.0984
71750468|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2226|TWO_SIDED|95.0|0.68|5.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.29|0.68|0.2226
71750469|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1467|TWO_SIDED|95.0|0.76|6.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||6.08|0.76|0.1467
71750470|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0705|TWO_SIDED|95.0|0.92|8.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.19|0.92|0.0705
71668587|NCT03281876|142853568|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group. The objective is to be considered a success if the lower limit of the 87% CI is above 0%.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|87.0|-18.27|11.58|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||11.58|-18.27|0.8157
71668588|NCT03281876|142853569|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the Control group.|Other: Vaccine Efficacy rate|-2.26||||0.8157|TWO_SIDED|95.0|-23.45|15.29|||Negative Binomial regression|Negative Binomial model with arm, country, gold grade, history of exacerbation and age category as covariates and log time as offset variable||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of moderate and severe AECOPDs||15.29|-23.45|0.8157
71668589|NCT03281876|142853576|OTHER|Vaccine Efficacy is defined as 1 minus the risk ratio (Rvacc / Rcon) based on the number of moderate and severe AECOPD observed in 1 year , with Rvacc = average yearly incidence rate of AECOPD events per subject in the GSK3277511A Group and Rcon = average yearly incidence rate of AECOPD events per subject in the control group.|Vaccine efficacy rate|-2.72||||0.77|TWO_SIDED|95.0|-22.95|14.19|||Negative Binomial regression|||To assess efficacy of the investigational vaccine as compared to the placebo control with respect to the rate of AECOPDs of any severity- upto 12 months follow up period||14.19|-22.95|0.7700
71668590|NCT03281876|142853578|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.94||||0.5751|TWO_SIDED|95.0|0.758|1.166|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe AECOPDs, one year follow-up starting 1 month post dose 2||1.166|0.758|0.5751
71668591|NCT03281876|142853579|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.934||||0.5194|TWO_SIDED|95.0|0.758|1.15|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any AECOPDs, one year follow-up starting 1 month post dose 2||1.15|0.758|0.5194
71782775|NCT00329238|143064638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7405||95.0|0.47|1.72|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to all deaths|Dabigatran versus Warfarin||1.72|0.47|0.7405
71668592|NCT03281876|142853580|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.05||||0.8581|TWO_SIDED|95.0|0.616|1.791|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild AECOPDs, one year follow-up starting 1 month post dose 2||1.791|0.616|0.8581
71668593|NCT03281876|142853580|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.995||||0.9634|TWO_SIDED|95.0|0.792|1.249|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate AECOPDs, one year follow-up starting 1 month post dose 2||1.249|0.792|0.9634
71668594|NCT03281876|142853580|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|0.722||||0.1755|TWO_SIDED|95.0|0.45|1.157|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe AECOPDs, one year follow-up starting 1 month post dose 2||1.157|0.45|0.1755
71835764|NCT06143670|143176808|SUPERIORITY||Adjusted Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.28|-0.16|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.16|-0.28|<0.0001
71835765|NCT06143670|143176808|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|-0.21|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.10|-0.21|<0.0001
71668595|NCT03281876|142853587|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.038||||0.9463|TWO_SIDED|95.0|0.73|1.477|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate or severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.477|0.73|0.9463
71668596|NCT03281876|142853588|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.093||||0.6042|TWO_SIDED|95.0|0.782|1.528|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for any NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.528|0.782|0.6042
71782776|NCT00329238|143064639|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9622||95.0|-0.89|0.84|||Kaplan-Meier|Risk difference for the time to all deaths at Month 18.||Dabigatran versus Warfarin||0.84|-0.89|0.9622
71782777|NCT00329238|143064640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.0577||95.0|0.27|1.02|||Regression, Cox||This is the analysis of the time to the first MBE.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||1.02|0.27|0.0577
71782778|NCT00329238|143064640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.||0.83|0.61|<0.0001
71668597|NCT03281876|142853589|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|2.243||||0.0777|TWO_SIDED|95.0|0.914|5.504|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for mild NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||5.504|0.914|0.0777
71835766|NCT06143670|143176808|SUPERIORITY||Adjusted Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.3|-0.18|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.18|-0.30|<0.0001
71835767|NCT06143670|143176809|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.15|-0.1|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.10|-0.15|<0.0001
71835768|NCT06143670|143176809|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.17|-0.13|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.13|-0.17|<0.0001
71835769|NCT06143670|143176809|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.16|-0.11|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.11|-0.16|<0.0001
71835770|NCT06143670|143176810|SUPERIORITY||Adjusted Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.74|-0.53|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.53|-0.74|<0.0001
71835771|NCT06143670|143176810|SUPERIORITY||Adjusted Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.74|-0.56|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.56|-0.74|<0.0001
71835772|NCT06143670|143176810|SUPERIORITY||Adjusted Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.77|-0.58|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.58|-0.77|<0.0001
71835773|NCT02815813|143176811|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
71835774|NCT02815813|143176812|SUPERIORITY||||||<|0.01|||||||GLMM|||||||<0.01
71835775|NCT04995484|143176827|OTHER||Geometric Mean Ratio|1.52|||||TWO_SIDED|90.0|0.95|2.43|||||Moderate Hepatic Impairment/Healthy|||2.43|0.95|
71835776|NCT04995484|143176828|OTHER||Geometric Mean Ratio|1.09|||||TWO_SIDED|90.0|0.84|1.42|||||Moderate Hepatic Impairment/Healthy|||1.42|0.84|
71750471|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|26.62||||0.0025|TWO_SIDED|95.0|3.16|223.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||223.9|3.16|0.0025
71750472|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.75||||0.0757|TWO_SIDED|95.0|0.9|8.4||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||8.40|0.90|0.0757
71835777|NCT04995484|143176829|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.76|1.26|||||Moderate Hepatic Impairment/Healthy|||1.26|0.76|
71835778|NCT00837369|143176834|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Compare the differences in sensitivity between myocardial perfusion and wall motion for detecting stenosis.|Chi-squared|||||||<0.001
71835779|NCT00837369|143176834|SUPERIORITY||||||<|0.001||||||Compare the sensitivity of myocardial perfusion in detecting stenosis within the first 4 minutes after regadenoson bolus injection to that of wall motion|Chi-squared|||||||<0.001
71835780|NCT04899115|143176866|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71835781|NCT04899115|143176867|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|Wilcoxon was used because data was not normal.||||||0.48
71835782|NCT05161715|143176880|OTHER|||||||0.425||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.425
71835783|NCT05161715|143176881|OTHER|||||||0.0002||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0002
71835784|NCT05161715|143176882|OTHER|||||||0.0424||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.0424
71835785|NCT05161715|143176883|OTHER|||||||0.001||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.001
71835786|NCT05161715|143176888|OTHER|||||||0.556||||||No multiple testing correction was performed|Wilcoxon (Mann-Whitney)|||||||0.556
71835787|NCT03743636|143176892|SUPERIORITY||Mean Difference (Final Values)|17.57||||0.0775|ONE_SIDED|90.0|1.77||||Mixed Models Analysis||||||1.77|0.0775
71835788|NCT03743636|143176893|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.3762|ONE_SIDED|90.0|-11.24||||Mixed Models Analysis||||||-11.24|0.3762
71835789|NCT03743636|143176894|SUPERIORITY||Mean Difference (Final Values)|22.42||||0.0294|ONE_SIDED|90.0|7.31||||Mixed Models Analysis||||||7.31|0.0294
71835790|NCT03743636|143176895|SUPERIORITY||Mean Difference (Final Values)|20.63||||0.0336|ONE_SIDED|90.0|6.26||||Mixed Models Analysis||||||6.26|0.0336
71835791|NCT03743636|143176896|SUPERIORITY||Mean Difference (Final Values)|-1.78||||0.562|ONE_SIDED|90.0|-16.51||||Mixed Models Analysis||||||-16.51|0.5620
71835792|NCT03743636|143176897|SUPERIORITY||Mean Difference (Final Values)|-13.93||||0.8797|ONE_SIDED|90.0|-29.15||||Mixed Models Analysis||||||-29.15|0.8797
71835793|NCT03743636|143176898|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24||||ANCOVA||||||0.24|0.0752
71835794|NCT03743636|143176899|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA||||||-15.19|0.8703
71835795|NCT03743636|143176900|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA||||||-2078|0.1402
71835796|NCT03743636|143176901|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.1249|ONE_SIDED|90.0|-0.21||||ANCOVA||||||-0.21|0.1249
71835797|NCT03743636|143176902|SUPERIORITY||Mean Difference (Final Values)|-5.05||||0.8039|ONE_SIDED|90.0|-12.62||||ANCOVA||||||-12.62|0.8039
71668598|NCT03281876|142853589|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.021||||0.9121|TWO_SIDED|95.0|0.71|1.467|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for moderate NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||1.467|0.71|0.9121
71668599|NCT03281876|142853589|OTHER|The dependent variable is the time to first occurrence of the event. The reference is the Placebo.|Hazard Ratio (HR)|1.12||||0.8737|TWO_SIDED|95.0|0.278|4.502|||Regression, Cox|Analysis using Cox proportional hazard regression including history of exacerbation, study treatment, GOLD grade and age group as covariate.||Hazard rate for severe NTHi-associated and/or Mcat-associated AECOPDs, one year follow-up starting 1 month post dose 2||4.502|0.278|0.8737
71668600|NCT02208089|142853601|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Null hypothesis = TransPRK produced no gains in vision over and above those produced by CXL only||||0.03
71668601|NCT02208089|142853602|SUPERIORITY|||||||0.005|||||||Chi-squared|||Null hypothesis = an equal proportion of patients in both study arms have clinically significant visual gains||||0.005
71668602|NCT02208089|142853603|NON_INFERIORITY|Non-inferiority = no significant difference between rates of clinically significant visual loss between groups at the p≤0.05 level||||||0.13|||||||Chi-squared|||null hypothesis = rates of clinically significant visual loss are equal for TransPRKCXL and CXL only||||0.13
71750473|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.66||||0.0045|TWO_SIDED|95.0|1.71|18.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||18.74|1.71|0.0045
71750474|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0771|TWO_SIDED|95.0|0.9|7.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.67|0.90|0.0771
71750475|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1856|TWO_SIDED|95.0|0.71|5.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.81|0.71|0.1856
71750476|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.31||||0.5973|TWO_SIDED|95.0|0.48|3.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||3.54|0.48|0.5973
71750477|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0935|TWO_SIDED|95.0|0.85|7.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.77|0.85|0.0935
71835798|NCT03743636|143176903|SUPERIORITY||Mean Difference (Final Values)|-842.0||||0.5352|ONE_SIDED|90.0|-13125.0||||ANCOVA||||||-13125|0.5352
71750478|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.52||||0.0157|TWO_SIDED|95.0|1.38|22.1||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||22.10|1.38|0.0157
71750479|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1963|TWO_SIDED|95.0|0.68|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.32|0.68|0.1963
71750480|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.31||||0.0085|TWO_SIDED|95.0|1.53|18.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||18.43|1.53|0.0085
71750481|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.21||||0.1433|TWO_SIDED|95.0|0.76|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.38|0.76|0.1433
71835799|NCT03743636|143176904|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.5777|ONE_SIDED|90.0|-2.46||||ANCOVA||||||-2.46|0.5777
71835800|NCT03743636|143176905|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.3662|ONE_SIDED|90.0|-5.69||||ANCOVA||||||-5.69|0.3662
71835801|NCT03743636|143176906|SUPERIORITY||Mean Difference (Final Values)|-11837.0||||0.8866|ONE_SIDED|90.0|-24396.0||||ANCOVA||||||-24396|0.8866
71835802|NCT03743636|143176907|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|25.25||||0.0153|ONE_SIDED|90.0|10.43|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|Mixed Models Analysis|||Mixed models for repeated measures were used to compare 3-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||10.43|0.0153
71668603|NCT00972595|142853606|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.98||||||90.0|0.93|1.03||||||Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.03|0.93|
71835803|NCT03743636|143176908|SUPERIORITY|Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|Mean Difference (Final Values)|14.05||||0.1195|ONE_SIDED|90.0|-1.25||||Mixed Models Analysis|||Mixed models for repeated measures were used to compare 6-month change in 6MW distance between the NR/resveratrol vs placebo groups and between the NR alone vs placebo groups using baseline, 3-month, and 6-month values, adjusted for age, sex, race, and baseline 6MW.|||-1.25|0.1195
71835804|NCT03743636|143176909|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0752|ONE_SIDED|90.0|0.24|||The a priori statistical analysis plan defined a one-sided P value of \< 0.10 to define statistical significance.|ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||0.24|0.0752
71835805|NCT03743636|143176910|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.8703|ONE_SIDED|90.0|-15.19||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-15.19|0.8703
71835806|NCT03743636|143176911|SUPERIORITY||Mean Difference (Final Values)|10995.0||||0.1402|ONE_SIDED|90.0|-2078.0||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-2078|0.1402
71835807|NCT03743636|143176912|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA||||||-81.20|0.8401
71835808|NCT03743636|143176913|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
71835809|NCT03743636|143176914|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA||||||-4.47|0.2378
71835810|NCT03743636|143176915|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.1589|ONE_SIDED|90.0|-1.86||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-1.86|0.1589
71835811|NCT03743636|143176915|SUPERIORITY||Mean Difference (Final Values)|11.14||||0.0602|ONE_SIDED|90.0|2.16||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||2.16|0.0602
71835812|NCT03743636|143176916|SUPERIORITY||Mean Difference (Final Values)|10.25||||0.3724|ONE_SIDED|90.0|-31.79||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-31.79|0.3724
71835813|NCT03743636|143176916|SUPERIORITY||Mean Difference (Final Values)|-35.13||||0.8401|ONE_SIDED|90.0|-81.2||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-81.20|0.8401
71835814|NCT03743636|143176917|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.5558|ONE_SIDED|90.0|-9.52||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-9.52|0.5558
71835815|NCT03743636|143176917|SUPERIORITY||Mean Difference (Final Values)|5.21||||0.2378|ONE_SIDED|90.0|-4.47||||ANCOVA|||Mixed model for repeated measures is applied to 3 groups comparisons. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-4.47|0.2378
71835816|NCT03743636|143176918|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA||||||-8.97|0.7112
71835817|NCT03743636|143176919|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA||||||-13.31|0.9449
71835818|NCT03743636|143176920|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.5409|ONE_SIDED|90.0|-6.57||||ANCOVA||||||-6.57|0.5409
71835819|NCT03743636|143176921|SUPERIORITY||Mean Difference (Final Values)|-3.35||||0.7814|ONE_SIDED|90.0|-8.89||||ANCOVA||||||-8.89|0.7814
71835820|NCT03743636|143176922|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.5884|ONE_SIDED|90.0|-7.07||||ANCOVA||||||-7.07|0.5884
71835821|NCT03743636|143176923|SUPERIORITY||Mean Difference (Final Values)|4.05||||0.1787|ONE_SIDED|90.0|-1.6||||ANCOVA||||||-1.60|0.1787
71835822|NCT03743636|143176924|SUPERIORITY||Mean Difference (Final Values)|-2.71||||0.7112|ONE_SIDED|90.0|-8.97||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-8.97|0.7112
71835823|NCT03743636|143176925|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.9449|ONE_SIDED|90.0|-13.31||||ANCOVA|||Mixed model for repeated measures is applied to Placebo vs. 2 NR groups combined. The reported results of within group change and between group difference are Least Squares Mean (Standard Error) from the model adjusted for baseline six-minute walk + age + sex + race + resveratrol usage.|||-13.31|0.9449
71835824|NCT03467542|143177004|OTHER||||||||||||||||||The total number evaluated, the percent, and the Clopper-Pearson two-sided 95% confidence limits on the percent.|||
71835825|NCT05387447|143177007|OTHER|||||||0.05|||||||Z score|||||||.05
71835826|NCT05387447|143177008|OTHER|||||||0.05|||||||Z score|||||||.05
71835827|NCT05387447|143177010|OTHER|||||||0.05|||||||Z score|||||||.05
71835828|NCT05387447|143177011|OTHER|||||||0.05|||||||Z score|||||||.05
71750482|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.17||||0.1577|TWO_SIDED|95.0|0.74|6.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.37|0.74|0.1577
71750483|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.16||||0.1608|TWO_SIDED|95.0|0.74|6.34||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.34|0.74|0.1608
71750484|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.96||||0.0693|TWO_SIDED|95.0|0.92|9.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.53|0.92|0.0693
71750485|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|9.57||||0.0063|TWO_SIDED|95.0|1.89|48.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||48.39|1.89|0.0063
71750486|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.25||||0.1637|TWO_SIDED|95.0|0.72|7.05||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||7.05|0.72|0.1637
71750487|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.57||||0.0326|TWO_SIDED|95.0|1.11|11.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||11.47|1.11|0.0326
71750488|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.24||||0.1455|TWO_SIDED|95.0|0.76|6.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.67|0.76|0.1455
71782779|NCT03652012|143064644|SUPERIORITY||Mean Difference (Final Values)|54.2||||0.044|TWO_SIDED|95.0|1.54|106.85||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference (Healthy Controls - MCI).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure."||106.85|1.54|0.044
71813101|NCT03720938|143128558|SUPERIORITY|||||||3.67e-06||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.||||0.00000367
71835829|NCT03391466|143177015|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.|Hazard Ratio (HR)|0.398|||<|0.0001|TWO_SIDED|95.0|0.308|0.514||Stratified (randomization factors) log-rank p-value.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% confidence interval (CI)), stratified using randomization stratification factors.|||0.514|0.308|<0.0001
71835830|NCT03391466|143177016|SUPERIORITY|One-sided p-value based on CMH test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Difference in ORR|33.1|||<|0.0001|TWO_SIDED|95.0|23.2|42.1||Stratified (randomization factor) CMH test p-value.|Cochran-Mantel-Haenszel|Stratified (randomization factor) CMH test.|Difference in ORR (95% CI)|||42.1|23.2|<0.0001
71845304|NCT01787032|143204592|SUPERIORITY_OR_OTHER||Ratio|372.88|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|345.456|402.477|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||402.477|345.456|
71750489|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1951|TWO_SIDED|95.0|0.69|6.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.32|0.69|0.1951
71750490|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.56||||0.4097|TWO_SIDED|95.0|0.54|4.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.53|0.54|0.4097
71750491|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1554|TWO_SIDED|95.0|0.73|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.22|0.73|0.1554
71750492|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.22||||0.044|TWO_SIDED|95.0|1.04|17.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.14|1.04|0.0440
71750493|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.23||||0.1928|TWO_SIDED|95.0|0.67|7.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.47|0.67|0.1928
71750494|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.67||||0.0222|TWO_SIDED|95.0|1.25|17.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||17.47|1.25|0.0222
71750495|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4075|TWO_SIDED|95.0|0.54|4.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.65|0.54|0.4075
71750496|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.65||||0.3659|TWO_SIDED|95.0|0.56|4.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.93|0.56|0.3659
71750497|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7878|TWO_SIDED|95.0|0.41|3.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||3.24|0.41|0.7878
71750498|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0635|TWO_SIDED|95.0|0.94|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||11.38|0.94|0.0635
71750499|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|14.62||||0.0137|TWO_SIDED|95.0|1.73|123.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||123.3|1.73|0.0137
71750500|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.91||||0.1069|TWO_SIDED|95.0|0.79|10.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||10.62|0.79|0.1069
71750501|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.6||||0.0186|TWO_SIDED|95.0|1.33|23.47||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||23.47|1.33|0.0186
71750502|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1434|TWO_SIDED|95.0|0.75|7.56||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||7.56|0.75|0.1434
71750503|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.2||||0.167|TWO_SIDED|95.0|0.72|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.75|0.72|0.1670
71750504|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.16||||0.781|TWO_SIDED|95.0|0.41|3.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||3.28|0.41|0.7810
71750505|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.27||||0.1682|TWO_SIDED|95.0|0.71|7.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||7.26|0.71|0.1682
71750506|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|5.22||||0.0215|TWO_SIDED|95.0|1.28|21.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||21.39|1.28|0.0215
71750507|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.75||||0.0306|TWO_SIDED|95.0|1.16|19.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||19.52|1.16|0.0306
71750508|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|10.1||||0.0059|TWO_SIDED|95.0|1.92|52.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||52.29|1.92|0.0059
71750509|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.64||||0.1004|TWO_SIDED|95.0|0.83|8.43||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||8.43|0.83|0.1004
71750510|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1837|TWO_SIDED|95.0|0.7|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.36|0.70|0.1837
71845305|NCT01787032|143204592|SUPERIORITY_OR_OTHER||Ratio|266.56|STANDARD_DEVIATION|16.0|||TWO_SIDED|90.0|242.955|292.456|||ANOVA|A bioequivalence acceptance range was not specified and no hypothesis was tested as the main focus was on estimation.|ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.|||292.456|242.955|
71845306|NCT01536093|143204618|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71845307|NCT01536093|143204619|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
71750511|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5929|TWO_SIDED|95.0|0.47|3.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||3.75|0.47|0.5929
71750512|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2588|TWO_SIDED|95.0|0.62|6.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.07|0.62|0.2588
71750513|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|7.69||||0.0129|TWO_SIDED|95.0|1.54|38.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||38.41|1.54|0.0129
71750514|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|7.12||||0.0168|TWO_SIDED|95.0|1.42|35.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||35.61|1.42|0.0168
71750515|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|9.95||||0.0058|TWO_SIDED|95.0|1.94|50.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||50.97|1.94|0.0058
71782780|NCT03652012|143064644|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.912|TWO_SIDED|95.0|-51.87|57.47||As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.|ANOVA||Mean difference in slope of the stimulus-response curve by muscle contraction condition (Active - Rest).|"We conducted a two-way factorial ANOVA (Group x Condition). Group has two levels: MCI and Healthy controls. Condition has two levels: active muscle contraction and rest.~As multiple parameters were assessed from the stimulus-response curve, a Bonferroni-adjusted alpha threshold of α = 0.0125 was applied to account for multiple comparisons when assessing this outcome measure.~The results presented here reflect the main effect of Condition on the slope of the stimulus-response curve."||57.47|-51.87|0.912
71782781|NCT03652012|143064645|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.1021|TWO_SIDED|95.0|-4.33|45.54|||t-test, 2 sided|No adjustment for multiple comparisons.|Mean cortical silent period (CSP; units = milliseconds) in the CN group minus mean CSP in the MCI group. Positive values indicate a longer cortical silent period in the control group.|||45.54|-4.33|0.1021
71782782|NCT03652012|143064646|SUPERIORITY||Mean Difference (Final Values)|0.208||||0.19|TWO_SIDED|95.0|-0.113|0.529|||t-test, 2 sided|||||0.529|-0.113|0.19
71782783|NCT03652012|143064647|SUPERIORITY||Mean Difference (Net)|0.0078||||0.97|TWO_SIDED|95.0|-0.51|0.5|||t-test, 2 sided|||||0.50|-0.51|0.97
71782784|NCT01302834|143064664|NON_INFERIORITY|The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was \<1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.|Hazard Ratio (HR)|1.45|||||ONE_SIDED|95.0||1.94|||||Reference level = IMRT + Cisplatin|||1.94||
71845308|NCT01536093|143204620|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71750516|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1934|TWO_SIDED|95.0|0.69|6.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.26|0.69|0.1934
71750517|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.01||||0.2181|TWO_SIDED|95.0|0.66|6.12||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.12|0.66|0.2181
71750518|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.58||||0.4116|TWO_SIDED|95.0|0.53|4.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.71|0.53|0.4116
71750519|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0938|TWO_SIDED|95.0|0.84|9.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||9.66|0.84|0.0938
71782785|NCT01302834|143064665|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.0002|TWO_SIDED|95.0|1.29|2.29|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||2.29|1.29|0.0002
71782786|NCT01302834|143064666|SUPERIORITY||Hazard Ratio (HR)|2.05||||0.0005|TWO_SIDED|95.0|1.35|3.1|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin|||3.10|1.35|0.0005
71782787|NCT01302834|143064667|SUPERIORITY||Hazard Ratio (HR)|1.49||||0.09|TWO_SIDED|95.0|0.94|2.36||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||2.36|0.94|0.09
71782788|NCT01302834|143064668|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.61|1.58||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin|||1.58|0.61|0.95
71782789|NCT01302834|143064670|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.0
71782790|NCT01302834|143064678|SUPERIORITY|||||||0.79||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.79
71845309|NCT01536093|143204621|SUPERIORITY_OR_OTHER|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||||||0.038
71845310|NCT01536093|143204622|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
71845311|NCT01536093|143204623|SUPERIORITY_OR_OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71845312|NCT01759862|143204669|SUPERIORITY|Our calculations showed that by enrolling 50 patients we will be able to detect a 25cc/min absolute difference in eGFR between the two arms with power above 80%, and a two-sided Type I probability error of \<0.05.||||||0.32|||||||t-test, 2 sided|||Intention to treat analysis||||0.32
71668604|NCT00972595|142853607|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.99||||||90.0|0.93|1.05||||||"Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally"||1.05|0.93|
71668605|NCT02085447|142853636|SUPERIORITY|||||||0.012|||||||t-test, 1 sided|||||||.012
71668606|NCT02085447|142853637|SUPERIORITY|||||||0.028|||||||t-test, 1 sided|||||||.028
71750520|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|8.02||||0.0125|TWO_SIDED|95.0|1.57|41.08||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||41.08|1.57|0.0125
71750521|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.29||||0.0761|TWO_SIDED|95.0|0.88|12.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||12.23|0.88|0.0761
71750522|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|4.02||||0.0305|TWO_SIDED|95.0|1.14|14.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||14.16|1.14|0.0305
71750523|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|3.42||||0.0501|TWO_SIDED|95.0|1.0|11.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.68|1.00|0.0501
71750524|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1212|TWO_SIDED|95.0|0.78|8.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.77|0.78|0.1212
71782791|NCT01302834|143064681|SUPERIORITY|||||||0.5438||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.5438
71782792|NCT01302834|143064685|SUPERIORITY|||||||0.7108||||||One-sided significance level = 0.05|t-test, 1 sided|||||||0.7108
71668607|NCT02085447|142853638|SUPERIORITY|||||||0.162|||||||t-test, 1 sided|||||||.162
71668608|NCT02085447|142853639|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||||||.021
71668609|NCT02085447|142853640|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||.005
71668610|NCT02085447|142853641|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71668611|NCT02085447|142853642|SUPERIORITY|||||||0.197|||||||t-test, 1 sided|||||||.197
71668612|NCT02085447|142853643|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71668613|NCT02085447|142853644|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71668614|NCT02085447|142853645|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71668615|NCT02085447|142853646|SUPERIORITY|||||||0.053|||||||t-test, 1 sided|||||||.053
71750525|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.13||||0.8332|TWO_SIDED|95.0|0.35|3.68||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||3.68|0.35|0.8332
71750526|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.66||||0.4285|TWO_SIDED|95.0|0.48|5.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.76|0.48|0.4285
71750527|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0954|TWO_SIDED|95.0|0.83|10.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||10.74|0.83|0.0954
71750528|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.98||||0.111|TWO_SIDED|95.0|0.78|11.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||11.38|0.78|0.1110
71782793|NCT00769392|143064716|OTHER|||||||0.28|||||||single factor analysis of variance|||A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.||||0.28
71782794|NCT00769392|143064717|OTHER|||||||0.17|||||||single factor analysis of variance|||A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.||||0.17
71782795|NCT02296320|143064722|SUPERIORITY||Relative risk reduction|31.9||||0.166|TWO_SIDED|90.0|-7.5|56.8|||Poisson regression with robust variance|||The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.||56.8|-7.5|0.166
71782796|NCT03087643|143064772|OTHER|||||||0.0492|||||||Mixed Models Analysis|||||||0.0492
71782797|NCT03087643|143064773|OTHER|||||||0.0283|||||||Mixed Models Analysis|||||||0.0283
71782798|NCT03087643|143064774|OTHER|||||||0.0321|||||||Mixed Models Analysis|||||||0.0321
71668616|NCT02085447|142853647|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71668617|NCT02085447|142853648|SUPERIORITY|||||||0.821|||||||t-test, 1 sided|||||||.821
71668618|NCT02085447|142853649|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
71668619|NCT02085447|142853650|SUPERIORITY|||||||0.425|||||||t-test, 1 sided|||||||.425
71668620|NCT02085447|142853651|SUPERIORITY|||||||0.577|||||||t-test, 1 sided|||||||.577
71668621|NCT02085447|142853652|SUPERIORITY|||||||0.33|||||||t-test, 1 sided|||||||.330
71668622|NCT02085447|142853653|SUPERIORITY|||||||0.706|||||||t-test, 1 sided|||||||.706
71668623|NCT02085447|142853654|SUPERIORITY|||||||0.481|||||||t-test, 1 sided|||||||.481
71782799|NCT03087643|143064775|OTHER|||||||0.0451|||||||Mixed Models Analysis|||||||0.0451
71782800|NCT03087643|143064776|OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
71782801|NCT00113022|143064778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|18.867||0.919|TWO_SIDED|95.0|-46.565|51.006||The test reported here examines the main effect for placebo versus drug.|Mixed Models Analysis||A positive value indicates greater depression in the active treatment group compared to placebo.|Per protocol, a linear mixed model with a first order autoregressive covariance structure was used. Baseline was included as a covariate. Drug and visit were main effects with an interaction between them included.||51.006|-46.565|.919
71782802|NCT02083783|143064779|SUPERIORITY||Mean Difference (Final Values)|-14.68|||<|0.0001|TWO_SIDED|95.0|-17.9|11.6|||ANCOVA|||Treatment difference in SKAMP-C scores from baseline to 4 hours postdose.||11.6|-17.9|<0.0001
71782803|NCT02083783|143064780|SUPERIORITY||Mean Difference (Final Values)|38.9|||<|0.0001|TWO_SIDED|95.0|27.3|50.6|||ANCOVA|||p-value for comparison between change from baseline in placebo vs active treatment||50.6|27.3|<0.0001
71782804|NCT00457301|143064827|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.1||0.05||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.05
71668624|NCT02085447|142853655|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.020
71668625|NCT02085447|142853656|SUPERIORITY|||||||0.103|||||||t-test, 1 sided|||||||.103
71782805|NCT00457301|143064828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||95.0|||||ANCOVA|||ANCOVA adjuusting for baseline HADS anxiety scores||||0.34
71782806|NCT00457301|143064828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||ANCOVA|||ANCOVA adjusting for baseline HADS depression scores.||||0.55
71668626|NCT02085447|142853657|SUPERIORITY|||||||0.063|||||||t-test, 1 sided|||||||.063
71668627|NCT02899962|142853745|SUPERIORITY|The primary endpoint was time to first relapse during the maintenance phase. This was calculated as the number of days from randomisation to the day where the subject had the first relapse confirmed. For subjects who either did not encounter a relapse or were withdrawn from the trial, the number of days was treated as a censored observation at the day of end of trial visit.|Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.47|0.69|||Regression, Cox||Estimates are obtained from a proportional hazards model with treatment group,pooled trial site,disease severity at maintenance baseline (Week 4; determined by PGA) as factors.|All randomized subjects were considered for statistical analysis.||0.69|0.47|<0.001
71668628|NCT02899962|142853746|SUPERIORITY||Mean Difference (Net)|0.11|||<|0.001|TWO_SIDED|95.0|0.08|0.14|||ANOVA|Factors adjusted for in the ANOVA model were treatment group, pooled trial site, and disease severity at maintenance baseline (PGA).|Multiple imputation of data for withdrawn subjects was done using 100 imputations and depended on whether the subject's reason for withdrawal potentially was related to treatment. Length of the maintenance phase was assumed to be 52 weeks (364 days)|The number of days in remission was calculated as the sum of days where the subject was in remission periods. The proportion of days in remission was calculated as the number of days in remission divided by the length of the maintenance phase in days.||0.14|0.08|<0.001
71668629|NCT02899962|142853747|SUPERIORITY||Rate ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.46|0.63|||Poisson regression||The number of relapses was analysed using a Poisson regression model with treatment group,pooled sites,disease severity at maintenance baseline as factors, subject as random effect, and time at risk as an offset.|||0.63|0.46|<0.001
71668630|NCT05287230|142853751|OTHER|||||||0.061||||||A priori threshold for statistical significance is p\<0.05.|ANOVA|||||||0.061
71668631|NCT02360215|142853770|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.029|TWO_SIDED|95.0|0.59|0.96|||Gray's test|||Null hypothesis: the addition of HA-WBRT as compared to WBRT will increase time to neurocognitive failure from 53.8% in the WBRT arm to 42.8% in the HA-WBRT arm at 6 months. Treating death as a competing risk and using a Gray's test with two-sided α=0.05 to test for statistically significant difference in the distribution of neurocognitive failure times, it was calculated that 230 events over both arms would provide 90% statistical power.||0.96|0.59|0.029
71668632|NCT02360215|142853771|SUPERIORITY|||||||0.0586|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0586
71782807|NCT00457301|143064829|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.79|STANDARD_ERROR_OF_MEAN|0.23||0.001||95.0|||||ANCOVA|||||||0.001
71782808|NCT00457301|143064830|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.46||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.||||0.46
71782809|NCT01552694|143064886|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted p-value compares the change (week 8 - baseline) for plasma hsCRP between the 2 groups.|t-test, 2 sided|||||||0.006
71668633|NCT02360215|142853771|SUPERIORITY|||||||0.0048|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\>61 year vs. \<= 61 years) is reported here.||||0.0048
71668634|NCT02360215|142853771|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Total Recall is reported here.||||<0.0001
71668635|NCT02360215|142853772|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2656
71668636|NCT02360215|142853772|SUPERIORITY|||||||0.0067|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0067
71668637|NCT02360215|142853772|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recall is reported here.||||<0.0001
71668638|NCT02360215|142853773|SUPERIORITY|||||||0.0993|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.0993
71677083|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.79|-5.79||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.79|-15.79|<0.0001
71750529|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.44||||0.1642|TWO_SIDED|95.0|0.69|8.55||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||8.55|0.69|0.1642
71750530|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|2.19||||0.1976|TWO_SIDED|95.0|0.66|7.24||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.24|0.66|0.1976
71750531|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5761|TWO_SIDED|95.0|0.43|4.58||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.58|0.43|0.5761
71750532|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.64||||0.454|TWO_SIDED|95.0|0.2|2.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.04|0.20|0.4540
71750533|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.57||||0.3732|TWO_SIDED|95.0|0.17|1.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||1.96|0.17|0.3732
71782810|NCT01552694|143064887|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis.|t-test, 2 sided|||||||0.24
71782811|NCT01552694|143064888|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Unadjusted analysis|t-test, 2 sided|||||||0.78
71782812|NCT01558271|143064912|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|||<|0.001|TWO_SIDED|95.0|-1.79|-1.35|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide greater than 99% power to demonstrate superiority of LY2189265 to placebo. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and placebo being 0.8%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||-1.35|-1.79|<0.001
71750534|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4665|TWO_SIDED|95.0|0.46|5.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.50|0.46|0.4665
71750535|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5634|TWO_SIDED|95.0|0.41|5.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.25|0.41|0.5634
71750536|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.65||||0.4297|TWO_SIDED|95.0|0.48|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||5.70|0.48|0.4297
71750537|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9789|TWO_SIDED|95.0|0.31|3.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.14|0.31|0.9789
71750538|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.81||||0.7357|TWO_SIDED|95.0|0.24|2.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.70|0.24|0.7357
71750539|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.46||||0.1977|TWO_SIDED|95.0|0.14|1.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.50|0.14|0.1977
71782813|NCT01558271|143064912|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) was \<0.4%, then LY2189265 was declared non-inferior to Liraglutide. If the upper limit of the 95% CI was \<0.0%, then LY2189265 was declared superior to liraglutide.|LS Mean Difference|-0.1||||0.248|TWO_SIDED|95.0|-0.27|0.07|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide \>90% power to confirm non-inferiority of LY2189265 to liraglutide by a margin of 0.4%. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and Liraglutide being 0%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.||0.07|-0.27|0.248
71782814|NCT01558271|143064913|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.04|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||||-0.01|-0.39|0.040
71782815|NCT01558271|143064914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
71782816|NCT01558271|143064914|SUPERIORITY_OR_OTHER|||||||0.608|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.608
71782817|NCT01558271|143064914|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||<0.001
71782818|NCT01558271|143064914|SUPERIORITY_OR_OTHER|||||||0.844|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.844
71782819|NCT01558271|143064914|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|||||Treatment comparison for HbA1c \<7% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.112
71782820|NCT01558271|143064914|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED|||||Treatment comparison for HbA1c \<=6.5% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (\<25 / \>=25 kg/m\^2), and baseline HbA1c group.||||||0.103
71782821|NCT01558271|143064915|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.21|||<|0.001|TWO_SIDED|95.0|-47.31|-33.11||Treatment comparison for FBG at 26 weeks between LY2189265 and placebo.|Mixed Models Analysis|||||-33.11|-47.31|<0.001
71782822|NCT01558271|143064915|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.835|TWO_SIDED|95.0|-4.82|5.96|||Mixed Models Analysis|Treatment comparison for FBG at 26 weeks between LY2189265 and Liraglutide.||||5.96|-4.82|0.835
71782823|NCT01558271|143064915|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77||||0.553|TWO_SIDED|95.0|-7.65|4.1||Treatment comparison for FBG at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||4.10|-7.65|0.553
71782824|NCT01558271|143064917|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.057|TWO_SIDED|95.0|-0.02|1.23|||Mixed Models Analysis|Treatment comparison for body weight at 26 weeks between LY2189265 and placebo.||||1.23|-0.02|0.057
71835831|NCT03391466|143177017|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.726||||0.0168|TWO_SIDED|95.0|0.54|0.977||Stratified log-rank (randomization factor) p-value.|Log Rank|Stratified (randomization factor) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.||The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.|0.977|0.540|0.0168
71668639|NCT02360215|142853773|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
71845313|NCT01759862|143204670|SUPERIORITY|Enrolling 25 patients in each group will allow us to detect a difference of 200ng/mg cr in urinary NGAL levels between the two groups with a power of 80% and a two-sided type I probability error of 0.05.||||||0.95|||||||Kruskal-Wallis|||||||0.95
71750540|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.52||||0.3203|TWO_SIDED|95.0|0.14|1.88||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.88|0.14|0.3203
71750541|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9739|TWO_SIDED|95.0|0.3|3.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.44|0.30|0.9739
71750542|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|1.33||||0.6714|TWO_SIDED|95.0|0.36|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||4.97|0.36|0.6714
71750543|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6375|TWO_SIDED|95.0|0.22|2.52||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.52|0.22|0.6375
71750544|NCT03192176|143005315|SUPERIORITY||Odds Ratio (OR)|0.54||||0.298|TWO_SIDED|95.0|0.17|1.71||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||1.71|0.17|0.2980
71750545|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.35||||0.0044|TWO_SIDED|95.0|1.69|16.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||16.96|1.69|0.0044
71782825|NCT01558271|143064917|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.168|TWO_SIDED|95.0|-0.14|0.82||Treatment comparison for body weight at 26 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.82|-0.14|0.168
71782826|NCT01558271|143064917|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.911|TWO_SIDED|95.0|-0.64|0.57||Treatment comparison for body weight at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis|||||0.57|-0.64|0.911
71782827|NCT01558271|143064918|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86||||0.723|TWO_SIDED|95.0|-12.2|8.48||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||8.48|-12.20|0.723
71782828|NCT01558271|143064918|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.998|TWO_SIDED|95.0|-7.92|7.91||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||7.91|-7.92|0.998
71750546|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|8.65||||0.0002|TWO_SIDED|95.0|2.79|26.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||26.83|2.79|0.0002
71750547|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|10.82|||<|0.0001|TWO_SIDED|95.0|3.49|33.54||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||33.54|3.49|<0.0001
71750548|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|10.01|||<|0.0001|TWO_SIDED|95.0|3.2|31.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||31.29|3.20|<0.0001
71750549|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.51||||0.1266|TWO_SIDED|95.0|0.77|8.15||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||8.15|0.77|0.1266
71750550|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.72||||0.0024|TWO_SIDED|95.0|1.85|17.66||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||17.66|1.85|0.0024
71750551|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|7.93||||0.0003|TWO_SIDED|95.0|2.59|24.26||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 1||24.26|2.59|0.0003
71750552|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0217|TWO_SIDED|95.0|1.18|8.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||8.17|1.18|0.0217
71750553|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.63||||0.0021|TWO_SIDED|95.0|1.75|12.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.25|1.75|0.0021
71750554|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.72||||0.0016|TWO_SIDED|95.0|1.8|12.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.37|1.80|0.0016
71750555|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0018|TWO_SIDED|95.0|1.79|12.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.86|1.79|0.0018
71750556|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0467|TWO_SIDED|95.0|1.01|7.14||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.14|1.01|0.0467
71750557|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.7||||0.0016|TWO_SIDED|95.0|1.8|12.28||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||12.28|1.80|0.0016
71750558|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.98||||0.0234|TWO_SIDED|95.0|1.16|7.65||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 2||7.65|1.16|0.0234
71750559|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.88||||0.0294|TWO_SIDED|95.0|1.11|7.46||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||7.46|1.11|0.0294
71750560|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.74||||0.0068|TWO_SIDED|95.0|1.44|9.73||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||9.73|1.44|0.0068
71835832|NCT03391466|143177018|SUPERIORITY|One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Hazard Ratio (HR)|0.736||||0.0695|TWO_SIDED|95.0|0.488|1.108||Stratified (randomization stratification factors) log-rank test.|Log Rank||Hazard ratio (95% CI), stratified using randomization stratification factors.|||1.108|0.488|0.0695
71750561|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.35||||0.0025|TWO_SIDED|95.0|1.68|11.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||11.29|1.68|0.0025
71750562|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.82||||0.0006|TWO_SIDED|95.0|2.13|15.92||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.92|2.13|0.0006
71750563|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0572|TWO_SIDED|95.0|0.97|6.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.61|0.97|0.0572
71750564|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|6.03||||0.0003|TWO_SIDED|95.0|2.28|15.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||15.97|2.28|0.0003
71750565|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.55||||0.046|TWO_SIDED|95.0|1.02|6.38||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 3||6.38|1.02|0.0460
71835833|NCT03391466|143177019|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.29|0.487||One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.|Log Rank|Stratified (randomization stratification factors) log-rank test.|Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.487|0.290|<0.0001
71835834|NCT03391466|143177020|SUPERIORITY||Hazard Ratio (HR)|0.422|||||TWO_SIDED|95.0|0.327|0.545|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.545|0.327|
71750566|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.03||||0.1406|TWO_SIDED|95.0|0.79|5.23||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.23|0.79|0.1406
71750567|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.97||||0.0234|TWO_SIDED|95.0|1.16|7.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.63|1.16|0.0234
71750568|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.82||||0.0302|TWO_SIDED|95.0|1.1|7.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||7.22|1.10|0.0302
71750569|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.23||||0.0016|TWO_SIDED|95.0|1.87|14.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||14.63|1.87|0.0016
71750570|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2105|TWO_SIDED|95.0|0.71|4.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||4.64|0.71|0.2105
71750571|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.17||||0.0033|TWO_SIDED|95.0|1.61|10.81||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||10.81|1.61|0.0033
71750572|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1087|TWO_SIDED|95.0|0.85|5.21||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 4||5.21|0.85|0.1087
71750573|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.56||||0.36|TWO_SIDED|95.0|0.6|4.03||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||4.03|0.60|0.3600
71750574|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.05||||0.1394|TWO_SIDED|95.0|0.79|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.32|0.79|0.1394
71750575|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0522|TWO_SIDED|95.0|0.99|7.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||7.36|0.99|0.0522
71750576|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.97||||0.0119|TWO_SIDED|95.0|1.63|11.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||11.61|1.63|0.0119
71750577|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1474|TWO_SIDED|95.0|0.77|5.53||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.53|0.77|0.1474
71750578|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.08||||0.0026|TWO_SIDED|95.0|1.76|14.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||14.67|1.76|0.0026
71750579|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.11||||0.1263|TWO_SIDED|95.0|0.81|5.51||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 5||5.51|0.81|0.1263
71782829|NCT01558271|143064918|SUPERIORITY_OR_OTHER||LS Mean Difference|0.83||||0.848|TWO_SIDED|95.0|-7.72|9.38||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||9.38|-7.72|0.848
71782830|NCT01558271|143064918|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.03||||0.357|TWO_SIDED|95.0|-9.48|3.42||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||3.42|-9.48|0.357
71782831|NCT01558271|143064918|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.49||||0.533|TWO_SIDED|95.0|-10.35|5.36||Treatment comparison for HOMA2-%S based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.36|-10.35|0.533
71782832|NCT01558271|143064918|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.747|TWO_SIDED|95.0|-7.32|5.25||Treatment comparison for HOMA2-%S based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.25|-7.32|0.747
71750580|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.83||||0.2327|TWO_SIDED|95.0|0.68|4.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||4.95|0.68|0.2327
71750581|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.12||||0.1359|TWO_SIDED|95.0|0.79|5.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||5.70|0.79|0.1359
71782833|NCT01558271|143064919|SUPERIORITY_OR_OTHER||LS Mean Difference|28.35|||<|0.001|TWO_SIDED|95.0|21.63|35.07||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA|||||35.07|21.63|<0.001
71782834|NCT01558271|143064919|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.242|TWO_SIDED|95.0|-2.09|8.24||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||8.24|-2.09|0.242
71782835|NCT01558271|143064919|SUPERIORITY_OR_OTHER||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|19.25|30.4||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA|||||30.40|19.25|<0.001
71782836|NCT01558271|143064919|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.376|TWO_SIDED|95.0|-2.32|6.13||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.13|-2.32|0.376
71782837|NCT01558271|143064919|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91||||0.417|TWO_SIDED|95.0|-2.72|6.54||Treatment comparison for HOMA2-%B based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||6.54|-2.72|0.417
71668640|NCT02360215|142853773|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recognition is reported here.||||<0.0001
71668641|NCT02360215|142853774|SUPERIORITY|||||||0.5988|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.5988
71782838|NCT01558271|143064919|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.753|TWO_SIDED|95.0|-3.83|5.29||Treatment comparison for HOMA2-%B based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA|||||5.29|-3.83|0.753
71782839|NCT01558271|143064920|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and placebo.|Fisher Exact|||||||>0.999
71782840|NCT01558271|143064920|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 26 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
71782841|NCT01558271|143064920|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||Treatment comparison at 52 weeks between LY2189265 and Liraglutide.|Fisher Exact|||||||>0.999
71835835|NCT03391466|143177021|SUPERIORITY||Hazard Ratio (HR)|0.506|||||TWO_SIDED|95.0|0.383|0.669|||||Hazard ratio (95% CI), stratified using randomization stratification factors.|||0.669|0.383|
71835836|NCT03391466|143177023|SUPERIORITY||Mixed Model with Repeated Measures|18.1|||<|0.0001|TWO_SIDED|95.0|12.3|23.9||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||23.9|12.3|<0.0001
71782842|NCT00147446|143064934|SUPERIORITY_OR_OTHER||Wilcoxon two smaple test statistics|2.09||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that treatment with stress management produced a significant reduction in cumulative Gd+ lesions compared to the control condition during the treatment period||||0.04
71782843|NCT00147446|143064934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.77||||0.02|TWO_SIDED|95.0|1.17|6.55|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving stress management remained free of Gd+ lesions during the treatment, compared to those receiving the control condition.||6.55|1.17|0.02
71782844|NCT00147446|143064935|SUPERIORITY_OR_OTHER||Wilcoxon two sample test statistics|2.84||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that participants receiving SMT-MS showed a significant reduction in cumulative new T2 lesions, compared to those receiving the control condition during the treatment period.||||0.005
71782845|NCT00147446|143064935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07||||0.006|TWO_SIDED|95.0|1.38|6.81|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.||6.81|1.38|0.006
71782846|NCT03307967|143064948|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum||||||.07
71782847|NCT03307967|143064949|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed Rank Sum Test||||||.98
71782848|NCT02166905|143064965|OTHER||Hazard Ratio (HR)|0.4||||0.177|TWO_SIDED|90.0|0.1|1.2|||Log Rank||Reference=arm 1|||1.2|0.1|0.177
71782849|NCT02617628|143064971|EQUIVALENCE|The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.|Odds Ratio (OR)|1.56||||0.38|TWO_SIDED|95.0|0.57|4.27|||Regression, Logistic||Threshold for significance was set at p\<.05|Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.||4.27|0.57|0.38
71782850|NCT02617628|143064972|SUPERIORITY||Cox Proportional Hazard|-0.74486||||0.01|TWO_SIDED|95.0|||||Regression, Cox|||We used Cox proportional hazards regression model to compare the groups on time to reincarceration.||||0.01
71835837|NCT03391466|143177023|SUPERIORITY||Mixed Model with Repeated Measures|9.8||||0.0124|TWO_SIDED|95.0|2.6|17.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.0|2.6|0.0124
71835838|NCT03391466|143177023|SUPERIORITY||Mixed Model with Repeated Measures|4.4||||0.2655|TWO_SIDED|95.0|-3.3|12.0||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Month 9.||12.0|-3.3|0.2655
71835839|NCT03391466|143177024|SUPERIORITY||Mixed Model with Repeated Measures|13.1|||<|0.0001|TWO_SIDED|95.0|8.0|18.2||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||18.2|8.0|<0.0001
71845314|NCT01759862|143204671|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
71845315|NCT02628626|143204683|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71845316|NCT02628626|143204684|SUPERIORITY|||||||0.24|||||||ANCOVA|||Approximately 4 weeks||||0.24
71845317|NCT02628626|143204685|SUPERIORITY|||||||0.44|||||||ANCOVA|||Approximately 4 weeks||||0.44
71845318|NCT02628626|143204686|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
71845319|NCT02628626|143204687|SUPERIORITY|||||||0.56|||||||ANCOVA|||Approximately 4 weeks||||0.56
71845320|NCT02628626|143204688|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
71845321|NCT02628626|143204689|SUPERIORITY|||||||0.11|||||||ANCOVA|||Small (staining only)||||0.11
71845322|NCT02628626|143204689|SUPERIORITY|||||||0.06|||||||ANCOVA|||Moderate (requires change of underwear)||||0.06
71845323|NCT02628626|143204689|SUPERIORITY|||||||0.36|||||||ANCOVA|||Large (requires complete change of clothes)||||0.36
71845324|NCT02628626|143204690|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
71845325|NCT02628626|143204691|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71835840|NCT03391466|143177024|SUPERIORITY||Mixed Model with Repeated Measures|5.1||||0.1253|TWO_SIDED|95.0|-0.9|11.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||11.0|-0.9|0.1253
71750582|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.35||||0.0258|TWO_SIDED|95.0|1.16|9.69||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||9.69|1.16|0.0258
71750583|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0076|TWO_SIDED|95.0|1.51|15.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||15.04|1.51|0.0076
71750584|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.36||||0.1088|TWO_SIDED|95.0|0.83|6.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||6.75|0.83|0.1088
71750585|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.89||||0.0045|TWO_SIDED|95.0|1.64|14.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||14.62|1.64|0.0045
71750586|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0493|TWO_SIDED|95.0|1.0|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 6||7.50|1.00|0.0493
71782851|NCT02065375|143064973|SUPERIORITY||Difference in proportion of patients|-1.2||||0.4543|TWO_SIDED|95.0|-21.3|18.9|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||18.9|-21.3|0.4543
71782852|NCT02065375|143064973|SUPERIORITY||Difference in proportion of patients|8.2||||0.2297|TWO_SIDED|95.0|-13.5|29.8|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||29.8|-13.5|0.2297
71782853|NCT02065375|143064974|SUPERIORITY||Difference in proportion of patients|-21.6||||0.028|TWO_SIDED|95.0|-43.1|0.0|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 1.0% and placebo were one sided.||||0.00|-43.1|.0280
71782854|NCT02065375|143064974|SUPERIORITY||Difference in proportion of patients|-24.0||||0.0192|TWO_SIDED|95.0|-45.8|-2.2|||Chi-squared|p values from Pearson chi-squared statistical test between the Omaveloxolone Ophthalmic suspension 0.5% and placebo were one sided.||||-2.2|-45.8|0.0192
71782855|NCT04518306|143064991|SUPERIORITY||LS Means Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.451|<|0.0001|TWO_SIDED|95.0|-10.176|-4.486||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ¼ GMRx2 and placebo at Week 4||-4.486|-10.176|<0.0001
71782856|NCT04518306|143064991|SUPERIORITY||LS Means Difference|-8.23|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|-11.305|-5.151||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MIANALYZE procedure|||The analysis was performed using a mixed model for repeated measures (MMRM) for estimating the difference between Triple ½ GMRx2 and placebo at Week 4||-5.151|-11.305|<0.0001
71782857|NCT04518306|143064992|SUPERIORITY||LS Means Difference|-7.98|STANDARD_ERROR_OF_MEAN|1.649|<|0.0001|TWO_SIDED|95.0|-11.281|-4.681||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-4.681|-11.281|<0.0001
71782858|NCT04518306|143064992|SUPERIORITY||LS Means Difference|-9.52|STANDARD_ERROR_OF_MEAN|2.034|<|0.0001|TWO_SIDED|95.0|-13.588|5.449||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||5.449|-13.588|<0.0001
71782859|NCT04518306|143064993|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.204||0.0015|TWO_SIDED|95.0|-6.413|-1.597||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-1.597|-6.413|0.0015
71782860|NCT04518306|143064993|SUPERIORITY||LS Means Difference|-4.86|STANDARD_ERROR_OF_MEAN|1.133|<|0.0001|TWO_SIDED|95.0|-7.13|-2.595||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.595|-7.130|<0.0001
71782861|NCT04518306|143064994|SUPERIORITY||Risk Difference (RD)|28.09||||0.0002|TWO_SIDED|95.0|11.811|42.45|||Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||42.450|11.811|0.0002
71782862|NCT04518306|143064994|SUPERIORITY||Risk Difference (RD)|33.24|||<|0.0001|TWO_SIDED|95.0|17.199|47.186|||Wald test||95% confidence intervals for risk difference utilize Newcombe estimation method|||47.186|17.199|<0.0001
71782863|NCT04518306|143064995|SUPERIORITY||Risk Difference (RD)|17.18|||<|0.0001|TWO_SIDED|95.0|6.07|26.385||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method.|Percentages were calculated from the total number of participants within the randomized set.||26.385|6.070|<0.0001
71782864|NCT04518306|143064995|SUPERIORITY||Risk Difference (RD)|27.08|||<|0.0001|TWO_SIDED|95.0|15.237|36.646||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|Percentages were calculated from the total number of participants within the randomized set||36.646|15.237|<0.0001
71835841|NCT03391466|143177025|SUPERIORITY||Mixed Model with Repeated Measures|0.081||||0.0112|TWO_SIDED|95.0|0.024|0.138||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 100.||0.138|0.024|0.0112
71835842|NCT03391466|143177025|SUPERIORITY||Mixed Model with Repeated Measures|0.028||||0.3703|TWO_SIDED|95.0|-0.034|0.091||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||0.091|-0.034|0.3703
71668642|NCT02360215|142853774|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0005
71750587|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0376|TWO_SIDED|95.0|1.06|8.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.41|1.06|0.0376
71750588|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0723|TWO_SIDED|95.0|0.92|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.94|0.92|0.0723
71750589|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.11||||0.0396|TWO_SIDED|95.0|1.06|9.17||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||9.17|1.06|0.0396
71750590|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|6.18||||0.0031|TWO_SIDED|95.0|1.85|20.67||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||20.67|1.85|0.0031
71750591|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.41||||0.1044|TWO_SIDED|95.0|0.83|6.96||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||6.96|0.83|0.1044
71750592|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0029|TWO_SIDED|95.0|1.78|16.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||16.75|1.78|0.0029
71750593|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.01||||0.0364|TWO_SIDED|95.0|1.07|8.45||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 7||8.45|1.07|0.0364
71750594|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6396|TWO_SIDED|95.0|0.47|3.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.37|0.47|0.6396
71750595|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.47||||0.4378|TWO_SIDED|95.0|0.55|3.91||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||3.91|0.55|0.4378
71750596|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.95||||0.2045|TWO_SIDED|95.0|0.7|5.44||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||5.44|0.70|0.2045
71750597|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0958|TWO_SIDED|95.0|0.85|7.62||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||7.62|0.85|0.0958
71750598|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.7||||0.321|TWO_SIDED|95.0|0.6|4.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||4.85|0.60|0.3210
71750599|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.75||||0.0199|TWO_SIDED|95.0|1.23|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||11.39|1.23|0.0199
71750600|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.26||||0.1219|TWO_SIDED|95.0|0.8|6.36||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 8||6.36|0.80|0.1219
71750601|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.72||||0.2975|TWO_SIDED|95.0|0.62|4.76||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.76|0.62|0.2975
71750602|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.75||||0.2763|TWO_SIDED|95.0|0.64|4.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||4.80|0.64|0.2763
71750603|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.33||||0.1235|TWO_SIDED|95.0|0.79|6.82||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.82|0.79|0.1235
71845326|NCT02628626|143204692|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
71668643|NCT02360215|142853774|SUPERIORITY||||||<|0.0001|||||||McNemar|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part A is reported here.||||<0.0001
71750604|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.24||||0.019|TWO_SIDED|95.0|1.27|14.19||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||14.19|1.27|0.0190
71750605|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2213|TWO_SIDED|95.0|0.66|5.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||5.93|0.66|0.2213
71750606|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.88||||0.005|TWO_SIDED|95.0|1.71|20.25||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||20.25|1.71|0.0050
71750607|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.39||||0.1053|TWO_SIDED|95.0|0.83|6.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 9||6.85|0.83|0.1053
71750608|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0991|TWO_SIDED|95.0|0.85|6.72||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||6.72|0.85|0.0991
71750609|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.93||||0.2056|TWO_SIDED|95.0|0.7|5.32||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||5.32|0.70|0.2056
71782865|NCT04518306|143064996|SUPERIORITY||LS Means Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.991||0.0002|TWO_SIDED|95.0|-5.978|-2.013||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-2.013|-5.978|0.0002
71782866|NCT04518306|143064996|SUPERIORITY||LS Means Difference|-5.51|STANDARD_ERROR_OF_MEAN|0.908|<|0.0001|TWO_SIDED|95.0|-7.328|-3.694||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||||-3.694|-7.328|<0.0001
71782867|NCT04518306|143064997|SUPERIORITY||LS Means Difference|-6.79|STANDARD_ERROR_OF_MEAN|1.752||0.0003|TWO_SIDED|95.0|-10.3|-3.287||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-3.287|-10.300|0.0003
71782868|NCT04518306|143064997|SUPERIORITY||LS Means Difference|-8.74|STANDARD_ERROR_OF_MEAN|1.829|<|0.0001|TWO_SIDED|95.0|-12.403|-5.082||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-5.082|-12.403|<0.0001
71782869|NCT04518306|143064998|SUPERIORITY||LS Means Difference|-3.86|STANDARD_ERROR_OF_MEAN|1.004||0.0003|TWO_SIDED|95.0|-5.865|-1.847||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ¼ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-1.847|-5.865|0.0003
71782870|NCT04518306|143064998|SUPERIORITY||LS Means Difference|-5.42|STANDARD_ERROR_OF_MEAN|1.245|<|0.0001|TWO_SIDED|95.0|-7.915|-2.932||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|MMRM procedure|||The difference between Triple ½ GMRx2 Dose and placebo at Week 4 was estimated using MMRM||-2.932|-7.915|<0.0001
71782871|NCT04518306|143064999|SUPERIORITY||Risk Difference (RD)|35.48|||<|0.0001|TWO_SIDED|95.0|19.541|48.549||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||48.549|19.541|<0.0001
71782872|NCT04518306|143064999|SUPERIORITY||Risk Difference (RD)|29.97|||<|0.0001|TWO_SIDED|95.0|14.218|43.093||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||43.093|14.218|<0.0001
71782873|NCT04518306|143065000|SUPERIORITY||Risk Difference (RD)|17.21||||0.003|TWO_SIDED|95.0|3.637|28.424||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||28.424|3.637|0.0030
71782874|NCT04518306|143065000|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.0001|TWO_SIDED|95.0|8.72|33.665||No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo|Wald test||95% confidence intervals for risk difference utilized Newcombe estimation method|||33.665|8.720|<0.0001
71845327|NCT02628626|143204693|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
71750610|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0407|TWO_SIDED|95.0|1.05|9.57||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||9.57|1.05|0.0407
71750611|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.47||||0.0059|TWO_SIDED|95.0|1.63|18.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||18.30|1.63|0.0059
71750612|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.85||||0.023|TWO_SIDED|95.0|1.2|12.3||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||12.30|1.20|0.0230
71750613|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|7.36||||0.0015|TWO_SIDED|95.0|2.14|25.29||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||25.29|2.14|0.0015
71750614|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0248|TWO_SIDED|95.0|1.17|10.16||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 10||10.16|1.17|0.0248
71750615|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.37||||0.1091|TWO_SIDED|95.0|0.82|6.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||6.83|0.82|0.1091
71750616|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.71||||0.3054|TWO_SIDED|95.0|0.61|4.75||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||4.75|0.61|0.3054
71750617|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.48||||0.1129|TWO_SIDED|95.0|0.81|7.61||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||7.61|0.81|0.1129
71750618|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.28||||0.0432|TWO_SIDED|95.0|1.04|10.37||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||10.37|1.04|0.0432
71750619|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.77||||0.0315|TWO_SIDED|95.0|1.13|12.6||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||12.60|1.13|0.0315
71750620|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|4.26||||0.0147|TWO_SIDED|95.0|1.33|13.64||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||13.64|1.33|0.0147
71750621|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0405|TWO_SIDED|95.0|1.05|9.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 11||9.59|1.05|0.0405
71782875|NCT04518306|143065001|SUPERIORITY||Risk Difference (RD)|-1.61|||||TWO_SIDED|95.0|-9.83|2.76|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.760|-9.830|
71845328|NCT02628626|143204694|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
71845329|NCT02628626|143204695|SUPERIORITY|approximately 4 weeks post-treatment||||||0.12|||||||ANCOVA|||||||0.12
71845330|NCT02628626|143204696|SUPERIORITY|||||||0.67|||||||ANCOVA|||Lifestyle Score||||0.67
71845331|NCT02628626|143204696|SUPERIORITY|||||||0.8|||||||ANCOVA|||Coping Score||||0.80
71845332|NCT02628626|143204696|SUPERIORITY|||||||0.49|||||||ANCOVA|||Depression Score||||0.49
71845333|NCT02628626|143204696|SUPERIORITY|||||||0.6|||||||ANCOVA|||Embarrassment Score||||0.60
71845334|NCT02628626|143204697|SUPERIORITY|||||||0.78|||||||ANCOVA|||Approximately 4 weeks post-treatment||||0.78
71845335|NCT05251363|143204716|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||Ho: SADE-free rate ≤ 87.5% Ha: SADE-free rate \> 87.5% Used an exact binomial test comparing the observed proportion (overall SADE-free rate through 3 months) to the performance goal of 87.5%. The lower, two-sided 95% confidence bound for the overall SADE-free rate must be greater than 87.5% to reject the null hypothesis (Ho), which would demonstrate evidence that the SADE-free rate is significantly higher than 87.5%.||||<0.0001
71845336|NCT05251363|143204717|SUPERIORITY||||||<|0.0001|||||||Exact binomial test|||H0: Implant Success Rate ≤ 80% Ha: Implant Success Rate \> 80% Used an exact binomial test comparing the observed proportion (implant success rate) to the performance goal of 80%. The lower, two-sided 95% confidence bound for the overall implant success rate must be greater than 80% to reject the null hypothesis (Ho), which would demonstrate evidence that the rate of successful Solia S LBBA implants is significantly higher than 80.0%.||||< 0.0001
71750622|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.4||||0.5238|TWO_SIDED|95.0|0.5|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||3.93|0.50|0.5238
71750623|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.73||||0.306|TWO_SIDED|95.0|0.6|4.97||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.97|0.60|0.3060
71750624|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.64||||0.3747|TWO_SIDED|95.0|0.55|4.86||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||4.86|0.55|0.3747
71750625|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.49||||0.0443|TWO_SIDED|95.0|1.03|11.8||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||11.80|1.03|0.0443
71750626|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.49||||0.1269|TWO_SIDED|95.0|0.77|8.06||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||8.06|0.77|0.1269
71750627|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|5.15||||0.0095|TWO_SIDED|95.0|1.49|17.13||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||17.13|1.49|0.0095
71750628|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1254|TWO_SIDED|95.0|0.79|6.94||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 12||6.94|0.79|0.1254
71750629|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|3.66||||0.0402|TWO_SIDED|95.0|1.06|12.63||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||12.63|1.06|0.0402
71750630|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.59||||0.4547|TWO_SIDED|95.0|0.47|5.42||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.42|0.47|0.4547
71750631|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.71||||0.4008|TWO_SIDED|95.0|0.49|5.99||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||5.99|0.49|0.4008
71750632|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.55||||0.1535|TWO_SIDED|95.0|0.71|9.22||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||9.22|0.71|0.1535
71750633|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|7.19||||0.0055|TWO_SIDED|95.0|1.79|28.95||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||28.95|1.79|0.0055
71750634|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.19||||0.2116|TWO_SIDED|95.0|0.64|7.5||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.50|0.64|0.2116
71750635|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.34||||0.1668|TWO_SIDED|95.0|0.7|7.83||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 13||7.83|0.70|0.1668
71782876|NCT04518306|143065001|SUPERIORITY||Risk Difference (RD)|3.47|||||TWO_SIDED|95.0|-5.276|9.774|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.774|-5.276|
71750636|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.32||||0.1824|TWO_SIDED|95.0|0.67|7.98||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.98|0.67|0.1824
71750637|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|0.85||||0.797|TWO_SIDED|95.0|0.25|2.9||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.90|0.25|0.7970
71750638|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|0.78||||0.7065|TWO_SIDED|95.0|0.21|2.85||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||2.85|0.21|0.7065
71782877|NCT04518306|143065002|SUPERIORITY||Risk Difference (RD)|-3.23|||||TWO_SIDED|95.0|-12.171|1.662|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||1.662|-12.171|
71782878|NCT04518306|143065002|SUPERIORITY||Risk Difference (RD)|-1.53|||||TWO_SIDED|95.0|-10.585|4.049||||||||4.049|-10.585|
71782879|NCT04518306|143065003|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.115|9.352|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.352|-4.115|
71750639|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9126|TWO_SIDED|95.0|0.29|3.93||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||3.93|0.29|0.9126
71750640|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.82||||0.1282|TWO_SIDED|95.0|0.74|10.7||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||10.70|0.74|0.1282
71750641|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.03||||0.2661|TWO_SIDED|95.0|0.58|7.04||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||7.04|0.58|0.2661
71750642|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7457|TWO_SIDED|95.0|0.36|4.09||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 14||4.09|0.36|0.7457
71750643|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.73||||0.4095|TWO_SIDED|95.0|0.47|6.41||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||6.41|0.47|0.4095
71750644|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9571|TWO_SIDED|95.0|0.28|3.77||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.77|0.28|0.9571
71750645|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8827|TWO_SIDED|95.0|0.23|3.59||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||3.59|0.23|0.8827
71750646|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|0.69||||0.5944|TWO_SIDED|95.0|0.17|2.74||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||2.74|0.17|0.5944
71750647|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.74||||0.1647|TWO_SIDED|95.0|0.66|11.39||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||11.39|0.66|0.1647
71750648|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|2.07||||0.2684|TWO_SIDED|95.0|0.57|7.48||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||7.48|0.57|0.2684
71750649|NCT03192176|143005316|SUPERIORITY||Odds Ratio (OR)|1.48||||0.5338|TWO_SIDED|95.0|0.43|5.07||Odds ratio, corresponding 95% CI and p-value are based on a logistic regression with responder as the dependent variable and treatment group and smoking status as factors and baseline measurement (mean frequency of vasomotor symptoms) as a covariate.|Regression, Logistic|||Week 15||5.07|0.43|0.5338
71750650|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.45||0.0179|TWO_SIDED|95.0|-1.95|-0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|Mixed model repeated measures (MMRM)|||Week 4||-0.18|-1.95|0.0179
71750651|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.25|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.47|-2.25|0.0027
71750652|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45||0.0004|TWO_SIDED|95.0|-2.5|-0.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.73|-2.50|0.0004
71750653|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.46||0.0009|TWO_SIDED|95.0|-2.43|-0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.64|-2.43|0.0009
71750654|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5806|TWO_SIDED|95.0|-1.14|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||0.64|-1.14|0.5806
71750655|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.45||0.0105|TWO_SIDED|95.0|-2.03|-0.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.27|-2.03|0.0105
71750656|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0048|TWO_SIDED|95.0|-2.16|-0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4||-0.39|-2.16|0.0048
71782880|NCT04518306|143065003|SUPERIORITY||Risk Difference (RD)|5.08|||||TWO_SIDED|95.0|-2.779|11.2||||||||11.200|-2.779|
71668644|NCT02360215|142853775|SUPERIORITY|||||||0.9226|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9226
71668645|NCT02360215|142853775|SUPERIORITY||||||<|0.0024|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0024
71782881|NCT04518306|143065004|SUPERIORITY||Risk Difference (RD)|3.54|||||TWO_SIDED|95.0|-4.012|9.35|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.350|-4.012|
71782882|NCT04518306|143065004|SUPERIORITY||Risk Difference (RD)|0.84|||||TWO_SIDED|95.0|-6.364|5.278|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.278|-6.364|
71782883|NCT04518306|143065005|SUPERIORITY||Risk Difference (RD)|-1.22|||||TWO_SIDED|95.0|-10.928|5.573|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||5.573|-10.928|
71668646|NCT02360215|142853775|SUPERIORITY||||||<|0.0001|||||||Regression, Cox|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part B is reported here.||||<0.0001
71668647|NCT02360215|142853776|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline COWA is reported here.||||<0.0001
71668648|NCT02360215|142853776|SUPERIORITY|||||||0.9749|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9749
71668649|NCT02360215|142853776|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here. is reported here.||||<0.0001
71668650|NCT02360215|142853777|SUPERIORITY|||||||0.2552|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.2552
71668651|NCT02360215|142853777|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||<0.0001
71782884|NCT04518306|143065005|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|1.38|9.53|||||95% confidence intervals for risk difference utilize Newcombe estimation method|||9.53|1.38|
71782885|NCT04518306|143065006|SUPERIORITY||Risk Difference (RD)|1.95|||||TWO_SIDED|95.0|-6.492|7.954|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||7.954|-6.492|
71782886|NCT04518306|143065006|SUPERIORITY||Risk Difference (RD)|3.45|||||TWO_SIDED|95.0|-5.171|9.704|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||9.704|-5.171|
71782887|NCT04518306|143065007|SUPERIORITY||Risk Difference (RD)|0.88|||||TWO_SIDED|95.0|-6.324|5.548|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||5.548|-6.324|
71782888|NCT04518306|143065007|SUPERIORITY||number of participants at 95% CI|0.0|||||TWO_SIDED|95.0|0.0|3.05|||||For this particular parameter we have used number of participants at 95% CI computed from Clopper-Pearson method as no risk difference was found between the Triple ½ (GMRx2) vs placebo|||3.05|0.00|
71782889|NCT04518306|143065008|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.778|||||95% confidence intervals for risk difference utilized Newcombe estimation method|||2.778|-9.684|
71668652|NCT02360215|142853777|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline composite score is reported here.||||<0.0001
71668653|NCT02360215|142853778|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.57
71668654|NCT02360215|142853778|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Severity score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline symptom severity is reported here.||||<0.0001
71782890|NCT04518306|143065008|SUPERIORITY||Risk Difference (RD)|-1.59|||||TWO_SIDED|95.0|-9.684|2.59|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||2.590|-9.684|
71782891|NCT04518306|143065009|SUPERIORITY||Risk Difference (RD)|4.27|||||TWO_SIDED|95.0|-6.722|12.959|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.959|-6.722|
71782892|NCT04518306|143065009|SUPERIORITY||Risk Difference (RD)|3.73|||||TWO_SIDED|95.0|-7.158|12.133|||||95% confidence intervals for risk difference utilized Newcombe estimation method.|||12.133|-7.158|
71782893|NCT04518306|143065010|SUPERIORITY||Risk Difference (RD)|1.43|||||TWO_SIDED|95.0|-8.585|8.916||||||||8.916|-8.585|
71782894|NCT04518306|143065010|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-11.077|5.161||||||||5.161|-11.077|
71782895|NCT04518306|143065011|SUPERIORITY||Risk Difference (RD)|-3.82|||<|0.0001|TWO_SIDED|95.0|-17.664|8.366|||GEE procedure|||||8.366|-17.664|<0.0001
71782896|NCT04518306|143065011|SUPERIORITY||LS Means|5.42|||<|0.0001|TWO_SIDED|95.0|-9.04|17.981|||GEE procedure|||||17.981|-9.040|<0.0001
71782897|NCT02801331|143065042|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A chi squared test of proportions was used for unadjusted comparisons.||||||0.6||||||Unadjusted|Chi-squared|||||||.60
71782898|NCT02801331|143065043|EQUIVALENCE|A statistical test comparing cumulative morphine dose was performed for the cohort that was treated with morphine (n=60)||||||0.62|||||||t-test, 2 sided|degrees of freedom =58 for cohort analyzed that received morphine treatment.||||||.62
71782899|NCT02801331|143065044|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants who completed hospitalization at study site (n=181).||||||0.29|||||||t-test, 2 sided|df = 179 based on number of infants who completed hospitalization at study site.||||||0.29
71782900|NCT02801331|143065045|EQUIVALENCE|A statistical test comparing day of life discharged among untreated infants (n=121)||||||0.55|||||||t-test, 2 sided|df = 119 based on number of infants who did not receive morphine treatment.||||||0.55
71782901|NCT02801331|143065046|EQUIVALENCE|A statistical test comparing day of life discharged among treated infants, n=60||||||0.36|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.36
71782902|NCT02801331|143065047|EQUIVALENCE|A test of equivalence was conducted for unadjusted comparisons. A t test of means was used for unadjusted comparisons.||||||0.56|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.56
71782903|NCT02801331|143065048|EQUIVALENCE|A statistical test comparing day of life infant started treatment as performed for the cohort that was treated with morphine (n=60)||||||0.25|||||||t-test, 2 sided|df = 58 based on number of infants who received morphine treatment.||||||0.25
71782904|NCT05438888|143065062|OTHER||Hazard Ratio (HR)|0.753|||<|0.001|TWO_SIDED|95.0|0.711|0.798|||Log Rank|||||0.798|0.711|<0.001
71782905|NCT05438888|143065063|OTHER||Hazard Ratio (HR)|0.687|||<|0.001|TWO_SIDED|95.0|0.622|0.76|||Log Rank|||||0.760|0.622|<0.001
71782906|NCT05438888|143065064|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.714|||Log Rank|||||0.714|0.570|<0.001
71782907|NCT05438888|143065065|OTHER||Hazard Ratio (HR)|0.854|||<|0.001|TWO_SIDED|95.0|0.791|0.922|||Log Rank|||||0.922|0.791|<0.001
71782908|NCT05438888|143065066|OTHER||Hazard Ratio (HR)|0.638|||<|0.001|TWO_SIDED|95.0|0.57|0.715|||Log Rank|||||0.715|0.570|<0.001
71782909|NCT05438888|143065067|OTHER||Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.807|0.934|||Log Rank|||||0.934|0.807|<0.001
71782910|NCT05438888|143065068|OTHER||Hazard Ratio (HR)|0.646|||<|0.001|TWO_SIDED|95.0|0.503|0.83|||Log Rank|||||0.830|0.503|<0.001
71782911|NCT02761252|143065069|SUPERIORITY||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.3429||0.5721|TWO_SIDED|95.0|-0.8693|0.4813|||ANCOVA|||||0.4813|-0.8693|0.5721
71782912|NCT02761252|143065070|SUPERIORITY||Mean Difference (Final Values)|-1.1552|STANDARD_ERROR_OF_MEAN|0.4489||0.0105|TWO_SIDED|95.0|-2.0379|-0.2725|||ANCOVA|||||-0.2725|-2.0379|0.0105
71782913|NCT02761252|143065071|SUPERIORITY||Mean Difference (Final Values)|-0.1393|STANDARD_ERROR_OF_MEAN|0.2009||0.4885|TWO_SIDED|95.0|-0.5342|0.2557|||ANCOVA|||||0.2557|-0.5342|0.4885
71782914|NCT02761252|143065072|SUPERIORITY||Mean Difference (Final Values)|-0.03615|STANDARD_ERROR_OF_MEAN|0.1504||0.81032|TWO_SIDED|95.0|-0.3319|0.2596|||ANCOVA|||||0.2596|-0.3319|0.81032
71782915|NCT02761252|143065073|OTHER||Mean Difference (Final Values)|0.8359|STANDARD_ERROR_OF_MEAN|0.9322||0.3704|TWO_SIDED|95.0|-0.9969|2.6688|||ANOVA|||||2.6688|-0.9969|0.3704
71782916|NCT02761252|143065074|SUPERIORITY||Median Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|2.5735||0.7452|TWO_SIDED|95.0|-5.8968|4.2228|||ANOVA|||||4.2228|-5.8968|0.7452
71782917|NCT00381485|143065135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71782918|NCT00381485|143065135|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71782919|NCT01206660|143065152|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71750657|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1801|TWO_SIDED|95.0|-1.52|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.29|-1.52|0.1801
71750658|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0609|TWO_SIDED|95.0|-1.76|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.04|-1.76|0.0609
71750659|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.47||0.0028|TWO_SIDED|95.0|-2.33|-0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.49|-2.33|0.0028
71750660|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.47||0.0018|TWO_SIDED|95.0|-2.4|-0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.55|-2.40|0.0018
71750661|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5519|TWO_SIDED|95.0|-1.19|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.64|-1.19|0.5519
71750662|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.46||0.1922|TWO_SIDED|95.0|-1.51|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||0.31|-1.51|0.1922
71750663|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.46||0.0463|TWO_SIDED|95.0|-1.82|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8||-0.02|-1.82|0.0463
71750664|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.1288|TWO_SIDED|95.0|-1.53|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.19|-1.53|0.1288
71750665|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0577|TWO_SIDED|95.0|-1.72|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.03|-1.72|0.0577
71750666|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.45||0.0027|TWO_SIDED|95.0|-2.26|-0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.48|-2.26|0.0027
71750667|NCT03192176|143005317|SUPERIORITY||-1.3|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0043|TWO_SIDED|95.0|-2.2|-0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.41|-2.20|0.0043
71750668|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.4089|TWO_SIDED|95.0|-1.27|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.52|-1.27|0.4089
71750669|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44||0.205|TWO_SIDED|95.0|-1.44|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||0.31|-1.44|0.2050
71750670|NCT03192176|143005317|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0265|TWO_SIDED|95.0|-1.84|-0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12||-0.11|-1.84|0.0265
71750671|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.7617|TWO_SIDED|95.0|-1.2|0.88||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.88|-1.20|0.7617
71782920|NCT01206660|143065153|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71782921|NCT01206660|143065154|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71782922|NCT03003390|143065173|SUPERIORITY||Posterior probabilities|0.09|||||TWO_SIDED||||||||||Using informative priors of B(1, 1) on the enoxaparin arm and B(18, 82) on the usual care arm, the risks of CADVT were 0.32 (95% CrI: 0.16, 0.51) in the enoxaparin arm and 0.25 (95% CrI: 0.18, 0.33) in the usual care arm. The posterior probability that the absolute difference in the risk of CADVT was lower by 0.06 in the enoxaparin arm was 9.1%. Using minimally informative priors, the risk ratio of CADVT with enoxaparin was 0.55 (95% CrI: 0.24, 1.11).|||
71782923|NCT03003390|143065174|SUPERIORITY|||||||0.22|||||||Linear mixed effects model|||||||0.22
71782924|NCT03003390|143065175|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71782925|NCT03003390|143065176|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71782926|NCT03003390|143065177|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71782927|NCT03003390|143065178|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71782928|NCT03003390|143065180|SUPERIORITY|||||||0.43|||||||Fisher Exact|||||||0.43
71750672|NCT03192176|143005317|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6061|TWO_SIDED|95.0|-0.77|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.32|-0.77|0.6061
71750673|NCT03192176|143005317|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.7997|TWO_SIDED|95.0|-0.93|1.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.21|-0.93|0.7997
71782929|NCT04249583|143065238|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
71782930|NCT03000439|143065245|OTHER||Hazard Ratio (HR)|0.633|||=|0.1171|TWO_SIDED|95.0|0.296|1.354||1-sided p-value is provided.|Unstratified log-rank test||Hazard ratio and 95% CI was based on Cox proportional hazards model with treatment group as covariate. Hazard ratio \< 1 indicates a reduction in hazard ratio in favor of Tofacitinib 5 mg BID to Placebo.|||1.354|0.296|= 0.1171
71835843|NCT03391466|143177026|SUPERIORITY||Mixed Model with Repeated Measures|13.7|||<|0.0001|TWO_SIDED|95.0|8.5|18.8||False Discovery Rate Methodology|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Day 100.||18.8|8.5|<0.0001
71835844|NCT03391466|143177026|SUPERIORITY||Mixed Model with Repeated Measures|11.3||||0.0004|TWO_SIDED|95.0|5.4|17.1||False Discovery Rate Methodology|Mixed Model with Repeated Measures|||Difference in mean change of scores from Baseline at Day 150.||17.1|5.4|0.0004
71835845|NCT03391466|143177026|SUPERIORITY||Mixed Model with Repeated Measures|3.8||||0.2549|TWO_SIDED|95.0|-2.3|10.0||False Discovery Rate Methodology.|Mixed Model with Repeated Measures|Mixed Model with Repeated Measures Differences in Change from Baseline.||Difference in mean change of scores from Baseline at Month 9.||10.0|-2.3|0.2549
71750674|NCT03192176|143005317|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3391|TWO_SIDED|95.0|-0.55|1.6||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.60|-0.55|0.3391
71750675|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.3934|TWO_SIDED|95.0|-1.55|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.61|-1.55|0.3934
71750676|NCT03192176|143005317|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.975|TWO_SIDED|95.0|-1.08|1.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||1.04|-1.08|0.9750
71750677|NCT03192176|143005317|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.883|TWO_SIDED|95.0|-1.13|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors and baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15||0.97|-1.13|0.8830
71750678|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.27||0.5872|TWO_SIDED|95.0|-6.09|10.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.73|-6.09|0.5872
71750679|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.8|STANDARD_ERROR_OF_MEAN|4.33||0.3779|TWO_SIDED|95.0|-4.7|12.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.35|-4.70|0.3779
71750680|NCT03192176|143005318|SUPERIORITY||LSMean difference|-4.1|STANDARD_ERROR_OF_MEAN|4.34||0.3506|TWO_SIDED|95.0|-12.61|4.49||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||4.49|-12.61|0.3506
71782931|NCT03000439|143065246|OTHER||Difference in percentage|0.7|||||TWO_SIDED|95.0|-12.2|13.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 4||13.6|-12.2|
71782932|NCT03000439|143065246|OTHER||Difference in percentage|-8.3|||||TWO_SIDED|95.0|-27.9|11.3|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 8||11.3|-27.9|
71782933|NCT03000439|143065246|OTHER||Difference in percentage|-10.8|||||TWO_SIDED|95.0|-33.2|11.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 12||11.6|-33.2|
71835846|NCT03655132|143177031|OTHER|Regression of baseline score on intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.12||||0.62|TWO_SIDED||||||Regression, Linear|||||||.62
71835847|NCT03655132|143177031|OTHER|Regression of baseline score on perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.19||||0.45|TWO_SIDED||||||Regression, Linear|||||||.45
71782934|NCT03000439|143065246|OTHER||Difference in percentage|-13.7|||||TWO_SIDED|95.0|-37.2|9.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 16||9.8|-37.2|
71896187|NCT02495077|143314345|SUPERIORITY||Mean Difference (Final Values)|-2.09||||0.411|TWO_SIDED|95.0|-7.08|2.91|||Mixed Models Analysis|||Day 180. Mean eGFR of the two treatment groups was compared. The p-value, estimated day 180 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group at day 180. Random effects for the intercept and eGFR collection day were utilized in the model.||2.91|-7.08|0.411
71750681|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.0|STANDARD_ERROR_OF_MEAN|4.39||0.8236|TWO_SIDED|95.0|-7.66|9.62||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||9.62|-7.66|0.8236
71750682|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.3|STANDARD_ERROR_OF_MEAN|4.35||0.5949|TWO_SIDED|95.0|-6.24|10.87||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||10.87|-6.24|0.5949
71750683|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.19||0.9237|TWO_SIDED|95.0|-8.65|7.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||7.85|-8.65|0.9237
71750684|NCT03192176|143005318|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.32||0.3599|TWO_SIDED|95.0|-4.54|12.46||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Getting to Sleep||12.46|-4.54|0.3599
71750685|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|5.08||0.7422|TWO_SIDED|95.0|-8.33|11.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||11.68|-8.33|0.7422
71750686|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|5.09||0.603|TWO_SIDED|95.0|-12.67|7.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||7.37|-12.67|0.6030
71750687|NCT03192176|143005318|SUPERIORITY||LSMean difference|-6.0|STANDARD_ERROR_OF_MEAN|5.14||0.2478|TWO_SIDED|95.0|-16.07|4.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||4.17|-16.07|0.2478
71750688|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|5.18||0.5295|TWO_SIDED|95.0|-6.94|13.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.47|-6.94|0.5295
71750689|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|5.16||0.6938|TWO_SIDED|95.0|-12.2|8.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||8.13|-12.20|0.6938
71750690|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.97||0.9765|TWO_SIDED|95.0|-9.93|9.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||9.63|-9.93|0.9765
71750691|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.7|STANDARD_ERROR_OF_MEAN|5.13||0.4771|TWO_SIDED|95.0|-6.45|13.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Quality of Sleep||13.76|-6.45|0.4771
71750692|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|4.44||0.4256|TWO_SIDED|95.0|-5.19|12.27||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||12.27|-5.19|0.4256
71782935|NCT03000439|143065246|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 20||11.5|-37.9|
71782936|NCT03000439|143065246|OTHER||Difference in percentage|-13.2|||||TWO_SIDED|95.0|-37.9|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 24||11.5|-37.9|
71750693|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|4.45||0.9559|TWO_SIDED|95.0|-8.52|9.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||9.01|-8.52|0.9559
71750694|NCT03192176|143005318|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|4.49||0.2003|TWO_SIDED|95.0|-14.6|3.07||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||3.07|-14.60|0.2003
71782937|NCT03000439|143065246|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-34.5|15.6|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 28||15.6|-34.5|
71782938|NCT03000439|143065246|OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-39.5|11.5|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 32||11.5|-39.5|
71896188|NCT02495077|143314346|SUPERIORITY|||||||0.569|||||||Chi-squared|||||||0.569
71896189|NCT02495077|143314347|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71896190|NCT02495077|143314348|SUPERIORITY|||||||0.451|||||||Chi-squared|||||||0.451
71896191|NCT02495077|143314349|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
71782939|NCT03000439|143065246|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 36||16.7|-35.5|
71782940|NCT03000439|143065246|OTHER||Difference in percentage|-9.4|||||TWO_SIDED|95.0|-35.5|16.7|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 40||16.7|-35.5|
71750695|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|4.53||0.6692|TWO_SIDED|95.0|-10.86|6.98||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||6.98|-10.86|0.6692
71750696|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.51||0.6894|TWO_SIDED|95.0|-10.68|7.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||7.08|-10.68|0.6894
71750697|NCT03192176|143005318|SUPERIORITY||LSMean difference|-6.1|STANDARD_ERROR_OF_MEAN|4.35||0.1627|TWO_SIDED|95.0|-14.66|2.48||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||2.48|-14.66|0.1627
71750698|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.48||0.9371|TWO_SIDED|95.0|-9.18|8.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Ease of Awaking From Sleep||8.47|-9.18|0.9371
71750699|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|4.53||0.8521|TWO_SIDED|95.0|-8.07|9.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.77|-8.07|0.8521
71750700|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.56||0.9367|TWO_SIDED|95.0|-8.62|9.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.35|-8.62|0.9367
71750701|NCT03192176|143005318|SUPERIORITY||LSMean difference|-8.8|STANDARD_ERROR_OF_MEAN|4.57||0.0551|TWO_SIDED|95.0|-17.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||0.19|-17.82|0.0551
71750702|NCT03192176|143005318|SUPERIORITY||LSMean differencce|-3.2|STANDARD_ERROR_OF_MEAN|4.64||0.4936|TWO_SIDED|95.0|-12.32|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||5.96|-12.32|0.4936
71750703|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|4.59||0.6404|TWO_SIDED|95.0|-6.89|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||11.17|-6.89|0.6404
71750704|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.45||0.8955|TWO_SIDED|95.0|-8.17|9.34||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.34|-8.17|0.8955
71782941|NCT03000439|143065246|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 44||11.8|-41.8|
71782942|NCT03000439|143065246|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 48||11.8|-41.8|
71782943|NCT03000439|143065246|OTHER||Difference in percentage|-15.0|||||TWO_SIDED|95.0|-41.8|11.8|||||The 95% CIs for the differences between the treatment groups were generated using Greenwood's formula.|DB Week 52||11.8|-41.8|
71782944|NCT03000439|143065249|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 4||5.21|-28.02|
71782945|NCT03000439|143065249|OTHER||Difference in percentage|1.5|||||TWO_SIDED|95.0|-18.37|21.36|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 8||21.36|-18.37|
71782946|NCT03000439|143065249|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 12||23.60|-22.68|
71782947|NCT03000439|143065249|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 16||34.10|-13.82|
71782948|NCT03000439|143065249|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 20||40.92|-8.43|
71896192|NCT02495077|143314350|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.710
71896193|NCT02495077|143314351|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
71835848|NCT03655132|143177031|OTHER|Regression of baseline score on perceived usefulness of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.02||||0.93|TWO_SIDED||||||Regression, Linear|||||||.93
71835849|NCT03655132|143177031|OTHER|Regression of post-intervention score of intrinsic motivation to use VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.51||||0.04|TWO_SIDED||||||Regression, Linear|||||||.04
71896194|NCT02495077|143314352|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.256|TWO_SIDED|95.0|-0.36|1.35|||Mixed Models Analysis|||24 Hours/Day 1. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 24 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 24 hours/day 1. A random effect for the intercept was utilized in the model.||1.35|-0.36|0.256
71750705|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|4.59||0.9776|TWO_SIDED|95.0|-8.91|9.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 4: Integrity of Behavior following Awaking||9.17|-8.91|0.9776
71750706|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|4.14||0.7852|TWO_SIDED|95.0|-9.27|7.01||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||7.01|-9.27|0.7852
71750707|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|4.15||0.7812|TWO_SIDED|95.0|-7.02|9.33||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.33|-7.02|0.7812
71750708|NCT03192176|143005318|SUPERIORITY||LSMean difference|-4.7|STANDARD_ERROR_OF_MEAN|4.23||0.2648|TWO_SIDED|95.0|-13.07|3.61||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||3.61|-13.07|0.2648
71750709|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|4.25||0.6312|TWO_SIDED|95.0|-10.41|6.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||6.32|-10.41|0.6312
71750710|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.4|STANDARD_ERROR_OF_MEAN|4.2||0.7416|TWO_SIDED|95.0|-6.89|9.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||9.67|-6.89|0.7416
71750711|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.3|STANDARD_ERROR_OF_MEAN|4.12||0.4254|TWO_SIDED|95.0|-4.83|11.41||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.41|-4.83|0.4254
71750712|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.4|STANDARD_ERROR_OF_MEAN|4.11||0.4038|TWO_SIDED|95.0|-4.66|11.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Getting to Sleep||11.54|-4.66|0.4038
71750713|NCT03192176|143005318|SUPERIORITY||LSMean difference|-4.8|STANDARD_ERROR_OF_MEAN|4.91||0.327|TWO_SIDED|95.0|-14.49|4.85||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||4.85|-14.49|0.3270
71750714|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.85||0.7333|TWO_SIDED|95.0|-11.21|7.9||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.90|-11.21|0.7333
71750715|NCT03192176|143005318|SUPERIORITY||LSMean difference|-7.5|STANDARD_ERROR_OF_MEAN|4.99||0.1319|TWO_SIDED|95.0|-17.36|2.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||2.28|-17.36|0.1319
71750716|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|5.0||0.6132|TWO_SIDED|95.0|-12.38|7.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||7.32|-12.38|0.6132
71750717|NCT03192176|143005318|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|4.98||0.4024|TWO_SIDED|95.0|-13.98|5.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||5.63|-13.98|0.4024
71835850|NCT03655132|143177031|OTHER|Regression of post-intervention score of perceived ease of use of the VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.54||||0.03|TWO_SIDED||||||Regression, Linear|||||||.03
71750718|NCT03192176|143005318|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|4.88||0.4904|TWO_SIDED|95.0|-12.97|6.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.23|-12.97|0.4904
71750719|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|4.87||0.5521|TWO_SIDED|95.0|-12.48|6.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Quality of Sleep||6.69|-12.48|0.5521
71750720|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.5||0.737|TWO_SIDED|95.0|-10.38|7.35||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||7.35|-10.38|0.7370
71750721|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|4.46||0.5269|TWO_SIDED|95.0|-11.62|5.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.96|-11.62|0.5269
71750722|NCT03192176|143005318|SUPERIORITY||LSMean difference|-3.9|STANDARD_ERROR_OF_MEAN|4.58||0.3937|TWO_SIDED|95.0|-12.93|5.11||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||5.11|-12.93|0.3937
71750723|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.59||0.846|TWO_SIDED|95.0|-8.15|9.94||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.94|-8.15|0.8460
71750724|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|4.57||0.5673|TWO_SIDED|95.0|-11.62|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||6.38|-11.62|0.5673
71750725|NCT03192176|143005318|SUPERIORITY||LSMean difference|4.0|STANDARD_ERROR_OF_MEAN|4.49||0.3791|TWO_SIDED|95.0|-4.88|12.79||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||12.79|-4.88|0.3791
71750726|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.47||0.834|TWO_SIDED|95.0|-7.86|9.73||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Ease of Awaking From Sleep||9.73|-7.86|0.8340
71750727|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|4.67||0.9457|TWO_SIDED|95.0|-9.51|8.88||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.88|-9.51|0.9457
71750728|NCT03192176|143005318|SUPERIORITY||LSMean difference|-2.1|STANDARD_ERROR_OF_MEAN|4.65||0.657|TWO_SIDED|95.0|-11.22|7.09||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||7.09|-11.22|0.6570
71750729|NCT03192176|143005318|SUPERIORITY||LSMean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.73||0.231|TWO_SIDED|95.0|-15.0|3.64||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||3.64|-15.00|0.2310
71782949|NCT03000439|143065249|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 24||34.39|-15.49|
71782950|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 28||34.33|-16.13|
71782951|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 32||34.33|-16.13|
71782952|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 36||34.33|-16.13|
71782953|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 40||34.33|-16.13|
71750730|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|4.77||0.9066|TWO_SIDED|95.0|-8.84|9.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.96|-8.84|0.9066
71750731|NCT03192176|143005318|SUPERIORITY||LSMean differnce|-5.0|STANDARD_ERROR_OF_MEAN|4.71||0.2914|TWO_SIDED|95.0|-14.26|4.3||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||4.30|-14.26|0.2914
71750732|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9277|TWO_SIDED|95.0|-8.73|9.57||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||9.57|-8.73|0.9277
71750733|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|4.64||0.9367|TWO_SIDED|95.0|-9.51|8.77||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 8: Integrity of Behavior Following Awaking||8.77|-9.51|0.9367
71750734|NCT03192176|143005318|SUPERIORITY||LSMean difference|5.1|STANDARD_ERROR_OF_MEAN|4.35||0.2407|TWO_SIDED|95.0|-3.46|13.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||13.69|-3.46|0.2407
71750735|NCT03192176|143005318|SUPERIORITY||LSMean difference|6.9|STANDARD_ERROR_OF_MEAN|4.55||0.1305|TWO_SIDED|95.0|-2.06|15.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.89|-2.06|0.1305
71750736|NCT03192176|143005318|SUPERIORITY||LSMean difference|5.7|STANDARD_ERROR_OF_MEAN|4.59||0.2152|TWO_SIDED|95.0|-3.34|14.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||14.75|-3.34|0.2152
71750737|NCT03192176|143005318|SUPERIORITY||LSMean difference|7.6|STANDARD_ERROR_OF_MEAN|4.72||0.1099|TWO_SIDED|95.0|-1.73|16.89||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.89|-1.73|0.1099
71750738|NCT03192176|143005318|SUPERIORITY||LSMean difference|7.4|STANDARD_ERROR_OF_MEAN|4.75||0.1219|TWO_SIDED|95.0|-1.99|16.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||16.75|-1.99|0.1219
71750739|NCT03192176|143005318|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|4.44||0.0316|TWO_SIDED|95.0|0.85|18.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||18.36|0.85|0.0316
71750740|NCT03192176|143005318|SUPERIORITY||LSMean difference|6.4|STANDARD_ERROR_OF_MEAN|4.47||0.1557|TWO_SIDED|95.0|-2.44|15.16||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Getting to Sleep||15.16|-2.44|0.1557
71750741|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|4.97||0.8592|TWO_SIDED|95.0|-8.91|10.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.67|-8.91|0.8592
71782954|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 44||34.33|-16.13|
71782955|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 48||37.56|-12.91|
71896195|NCT02495077|143314352|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.391|TWO_SIDED|95.0|-0.48|1.23|||Mixed Models Analysis|||48 Hours/Day 2. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 48 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 48 hours/day 2. A random effect for the intercept was utilized in the model.||1.23|-0.48|0.391
71750742|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.1|STANDARD_ERROR_OF_MEAN|5.15||0.6891|TWO_SIDED|95.0|-8.08|12.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||12.20|-8.08|0.6891
71782956|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR30 at DB Week 52||37.56|-12.91|
71782957|NCT03000439|143065249|OTHER||Difference in percentage|-11.41|||||TWO_SIDED|95.0|-28.02|5.21|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 4||5.21|-28.02|
71750743|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.2||0.9481|TWO_SIDED|95.0|-10.59|9.92||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||9.92|-10.59|0.9481
71750744|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|5.36||0.7246|TWO_SIDED|95.0|-12.46|8.68||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||8.68|-12.46|0.7246
71750745|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.8|STANDARD_ERROR_OF_MEAN|5.45||0.8842|TWO_SIDED|95.0|-9.94|11.53||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.53|-9.94|0.8842
71750746|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.2|STANDARD_ERROR_OF_MEAN|5.05||0.8103|TWO_SIDED|95.0|-8.74|11.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||11.17|-8.74|0.8103
71750747|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.1||0.9631|TWO_SIDED|95.0|-9.81|10.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Quality of Sleep||10.28|-9.81|0.9631
71750748|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|4.87||0.9788|TWO_SIDED|95.0|-9.73|9.47||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||9.47|-9.73|0.9788
71750749|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|5.02||0.7875|TWO_SIDED|95.0|-11.26|8.54||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||8.54|-11.26|0.7875
71750750|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|5.08||0.9746|TWO_SIDED|95.0|-9.85|10.17||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.17|-9.85|0.9746
71750751|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|5.21||0.9092|TWO_SIDED|95.0|-9.67|10.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.86|-9.67|0.9092
71750752|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|5.27||0.9745|TWO_SIDED|95.0|-10.55|10.21||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||10.21|-10.55|0.9745
71750753|NCT03192176|143005318|SUPERIORITY||LSMean difference|4.7|STANDARD_ERROR_OF_MEAN|4.95||0.3458|TWO_SIDED|95.0|-5.08|14.44||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||14.44|-5.08|0.3458
71750754|NCT03192176|143005318|SUPERIORITY||LSMean differnce|3.6|STANDARD_ERROR_OF_MEAN|4.98||0.4657|TWO_SIDED|95.0|-6.17|13.45||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Ease of Awaking From Sleep||13.45|-6.17|0.4657
71782958|NCT03000439|143065249|OTHER||Difference in percentage|4.72|||||TWO_SIDED|95.0|-15.72|25.17|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 8||25.17|-15.72|
71782959|NCT03000439|143065249|OTHER||Difference in percentage|0.46|||||TWO_SIDED|95.0|-22.68|23.6|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 12||23.60|-22.68|
71750755|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.8|STANDARD_ERROR_OF_MEAN|5.07||0.5838|TWO_SIDED|95.0|-7.2|12.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.76|-7.20|0.5838
71896196|NCT02495077|143314352|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.199|TWO_SIDED|95.0|-0.3|1.42|||Mixed Models Analysis|||72 Hours/Day 3. Mean serum creatinine of the two treatment groups was compared. The p-value, estimated 72 hour creatinine level within each treatment group, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available serum creatinine data from 24, 48, and 72 hours to compare the experimental group to the control group at 72 hours/day 3. A random effect for the intercept was utilized in the model.||1.42|-0.30|0.199
71782960|NCT03000439|143065249|OTHER||Difference in percentage|13.36|||||TWO_SIDED|95.0|-10.76|37.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 16||37.48|-10.76|
71782961|NCT03000439|143065249|OTHER||Difference in percentage|19.47|||||TWO_SIDED|95.0|-5.2|44.14|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 20||44.14|-5.20|
71750756|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.1|STANDARD_ERROR_OF_MEAN|5.22||0.8322|TWO_SIDED|95.0|-9.18|11.39||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||11.39|-9.18|0.8322
71750757|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.8|STANDARD_ERROR_OF_MEAN|5.26||0.7366|TWO_SIDED|95.0|-8.59|12.13||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||12.13|-8.59|0.7366
71750758|NCT03192176|143005318|SUPERIORITY||LSMean difference|5.6|STANDARD_ERROR_OF_MEAN|5.4||0.2971|TWO_SIDED|95.0|-4.99|16.28||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||16.28|-4.99|0.2971
71750759|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|5.41||0.9562|TWO_SIDED|95.0|-10.96|10.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||10.37|-10.96|0.9562
71750760|NCT03192176|143005318|SUPERIORITY||0.28|8.7|STANDARD_ERROR_OF_MEAN|5.13||0.0926|TWO_SIDED|95.0|-1.44|18.76||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||18.76|-1.44|0.0926
71750761|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.5|STANDARD_ERROR_OF_MEAN|5.18||0.4996|TWO_SIDED|95.0|-6.7|13.7||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 12: Integrity of Behavior Following Awaking||13.70|-6.70|0.4996
71750762|NCT03192176|143005318|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|4.76||0.896|TWO_SIDED|95.0|-9.99|8.75||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.75|-9.99|0.8960
71750763|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|4.89||0.5471|TWO_SIDED|95.0|-6.68|12.58||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||12.58|-6.68|0.5471
71750764|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.7|STANDARD_ERROR_OF_MEAN|4.93||0.738|TWO_SIDED|95.0|-8.06|11.36||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||11.36|-8.06|0.7380
71750765|NCT03192176|143005318|SUPERIORITY||LSMean difference|9.6|STANDARD_ERROR_OF_MEAN|5.14||0.0644|TWO_SIDED|95.0|-0.58|19.69||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||19.69|-0.58|0.0644
71782962|NCT03000439|143065249|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 24||34.39|-15.49|
71750766|NCT03192176|143005318|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|5.04||0.8475|TWO_SIDED|95.0|-10.9|8.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||8.96|-10.90|0.8475
71782963|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 28||34.33|-16.13|
71782964|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 32||34.33|-16.13|
71782965|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 36||34.33|-16.13|
71782966|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 40||34.33|-16.13|
71782967|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 44||37.56|-12.91|
71782968|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 48||37.56|-12.91|
71782969|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR50 at DB Week 52||37.56|-12.91|
71782970|NCT03000439|143065249|OTHER||Difference in percentage|-13.82|||||TWO_SIDED|95.0|-38.14|10.49|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 4||10.49|-38.14|
71896197|NCT02495077|143314353|SUPERIORITY|||||||0.812|||||||Log Rank|||||||0.812
71750767|NCT03192176|143005318|SUPERIORITY||LSMean difference|5.0|STANDARD_ERROR_OF_MEAN|4.86||0.3044|TWO_SIDED|95.0|-4.57|14.59||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||14.59|-4.57|0.3044
71750768|NCT03192176|143005318|SUPERIORITY||LSMean difference|4.2|STANDARD_ERROR_OF_MEAN|4.89||0.3895|TWO_SIDED|95.0|-5.42|13.86||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Getting to Sleep||13.86|-5.42|0.3895
71750769|NCT03192176|143005318|SUPERIORITY||LSMean difference|-4.5|STANDARD_ERROR_OF_MEAN|6.07||0.4551|TWO_SIDED|95.0|-16.5|7.42||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||7.42|-16.50|0.4551
71750770|NCT03192176|143005318|SUPERIORITY||LSMean differencce|-2.2|STANDARD_ERROR_OF_MEAN|6.1||0.7182|TWO_SIDED|95.0|-14.21|9.81||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.81|-14.21|0.7182
71750771|NCT03192176|143005318|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|6.21||0.6259|TWO_SIDED|95.0|-15.26|9.2||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||9.20|-15.26|0.6259
71750772|NCT03192176|143005318|SUPERIORITY||LSMean difference|6.6|STANDARD_ERROR_OF_MEAN|6.5||0.312|TWO_SIDED|95.0|-6.22|19.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||19.40|-6.22|0.3120
71750773|NCT03192176|143005318|SUPERIORITY||LSMean difference|-6.3|STANDARD_ERROR_OF_MEAN|6.41||0.3297|TWO_SIDED|95.0|-18.89|6.37||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||6.37|-18.89|0.3297
71750774|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|6.16||0.613|TWO_SIDED|95.0|-9.02|15.26||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||15.26|-9.02|0.6130
71750775|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|6.22||0.7292|TWO_SIDED|95.0|-10.09|14.4||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Quality of Sleep||14.40|-10.09|0.7292
71750776|NCT03192176|143005318|SUPERIORITY||LSMean difference|0.9|STANDARD_ERROR_OF_MEAN|5.6||0.8695|TWO_SIDED|95.0|-1.11|11.96||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||11.96|-1.11|0.8695
71750777|NCT03192176|143005318|SUPERIORITY||LSMean difference|3.1|STANDARD_ERROR_OF_MEAN|5.64||0.58|TWO_SIDED|95.0|-7.99|14.25||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||14.25|-7.99|0.5800
71750778|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.2|STANDARD_ERROR_OF_MEAN|5.74||0.7024|TWO_SIDED|95.0|-9.11|13.5||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.50|-9.11|0.7024
71750779|NCT03192176|143005318|SUPERIORITY||LSMean difference|11.4|STANDARD_ERROR_OF_MEAN|5.99||0.0572|TWO_SIDED|95.0|-0.35|23.23||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||23.23|-0.35|0.0572
71750780|NCT03192176|143005318|SUPERIORITY||LSMean difference|1.6|STANDARD_ERROR_OF_MEAN|5.93||0.783|TWO_SIDED|95.0|-10.04|13.31||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||13.31|-10.04|0.7830
71750781|NCT03192176|143005318|SUPERIORITY||0.1|15.4|STANDARD_ERROR_OF_MEAN|5.71||0.0074|TWO_SIDED|95.0|4.19|26.67||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||26.67|4.19|0.0074
71782971|NCT03000439|143065249|OTHER||Difference in percentage|-9.56|||||TWO_SIDED|95.0|-32.28|13.15|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 8||13.15|-32.28|
71782972|NCT03000439|143065249|OTHER||Difference in percentage|-0.23|||||TWO_SIDED|95.0|-24.7|24.24|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 12||24.24|-24.70|
71782973|NCT03000439|143065249|OTHER||Difference in percentage|5.88|||||TWO_SIDED|95.0|-19.31|31.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 16||31.06|-19.31|
71750782|NCT03192176|143005318|SUPERIORITY||LSMean difference|11.0|STANDARD_ERROR_OF_MEAN|5.73||0.0551|TWO_SIDED|95.0|-0.24|22.32||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Ease of Awaking From Sleep||22.32|-0.24|0.0551
71750783|NCT03192176|143005318|SUPERIORITY||LSMean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.51||0.2959|TWO_SIDED|95.0|-16.63|5.08||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||5.08|-16.63|0.2959
71891667|NCT05817045|143304665|SUPERIORITY|adjusted for the following prognostic baseline covariates: baseline log10 nasopharyngeal viral load, ethnicity, hours since symptom onset, and baseline risk factor score|Hazard Ratio (HR)|1.35||||0.007|TWO_SIDED|95.0|1.086|1.69|||NPANCOVA||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|NPANCOVA analysis for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) - Secondary analysis - (FAS excluding subjects that were qPCR negative at baseline)||1.690|1.086|0.007
71896198|NCT02495077|143314354|SUPERIORITY|||||||0.576|||||||Chi-squared|||||||0.576
71668655|NCT02360215|142853778|SUPERIORITY|||||||0.083|||||||Mixed Models Analysis|||A two-sample t-test with a 2-sided type I error of 0.05 provides \>90% statistical power to detect a medium effect size of 0.5 for a comparison of the change from baseline to 6 months from the start of treatment. The comparison at six months was tested within a mixed effects model with covariates age, RPA class, prior radiosurgery, prior surgical resection, baseline score, treatment arm, and time was used.||||0.083
71750784|NCT03192176|143005318|SUPERIORITY||LSMean difference|5.8|STANDARD_ERROR_OF_MEAN|5.55||0.2976|TWO_SIDED|95.0|-5.14|16.74||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||16.74|-5.14|0.2976
71750785|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.0|STANDARD_ERROR_OF_MEAN|5.62||0.7236|TWO_SIDED|95.0|-9.07|13.05||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.05|-9.07|0.7236
71750786|NCT03192176|143005318|SUPERIORITY||LSMean difference|10.1|STANDARD_ERROR_OF_MEAN|5.88||0.0884|TWO_SIDED|95.0|-1.52|21.63||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||21.63|-1.52|0.0884
71750787|NCT03192176|143005318|SUPERIORITY||LSMean difference|-5.0|STANDARD_ERROR_OF_MEAN|5.77||0.3887|TWO_SIDED|95.0|-16.35|6.38||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||6.38|-16.35|0.3887
71750788|NCT03192176|143005318|SUPERIORITY||LSMean difference|6.2|STANDARD_ERROR_OF_MEAN|5.59||0.2671|TWO_SIDED|95.0|-4.8|17.24||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||17.24|-4.80|0.2671
71750789|NCT03192176|143005318|SUPERIORITY||LSMean difference|2.9|STANDARD_ERROR_OF_MEAN|5.63||0.6076|TWO_SIDED|95.0|-8.2|13.99||LSM, SE, CI, \& p-values come from an MMRM model with domain score as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement (BM) as a covariate, as well as interaction of treatment by week \& an interaction of BM by week.|MMRM|||Week 15: Integrity of Behavior Following Awaking||13.99|-8.20|0.6076
71750790|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.91||0.2159|TWO_SIDED|95.0|-2.93|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.67|-2.93|0.2159
71750791|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0405|TWO_SIDED|95.0|-3.7|-0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.08|-3.70|0.0405
71750792|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.93||0.0115|TWO_SIDED|95.0|-4.18|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.53|-4.18|0.0115
71750793|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.93||0.0553|TWO_SIDED|95.0|-3.62|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.04|-3.62|0.0553
71750794|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.92||0.2753|TWO_SIDED|95.0|-2.82|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||0.80|-2.82|0.2753
71782974|NCT03000439|143065249|OTHER||Difference in percentage|19.12|||||TWO_SIDED|95.0|-5.81|44.06|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 20||44.06|-5.81|
71750795|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.514|TWO_SIDED|95.0|-1.2|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||2.40|-1.20|0.5140
71750796|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.93||0.0178|TWO_SIDED|95.0|-4.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Symptoms Score||-0.38|-4.03|0.0178
71750797|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9675|TWO_SIDED|95.0|-1.02|0.98||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.98|-1.02|0.9675
71835851|NCT03655132|143177031|OTHER|Regression of post-intervention score of perceived usefulness of VACT-CP online program on actual VACT-CP use (i.e., number of modules completed.)|Pearson's correlation coefficient|0.58||||0.01|TWO_SIDED||||||Regression, Linear|||||||.01
71750798|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3122|TWO_SIDED|95.0|-1.52|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.49|-1.52|0.3122
71750799|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9977|TWO_SIDED|95.0|-1.0|1.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.00|-1.00|0.9977
71750800|NCT03192176|143005319|SUPERIORITY||LSMean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.51||0.9312|TWO_SIDED|95.0|-1.05|0.97||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.97|-1.05|0.9312
71750801|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.6005|TWO_SIDED|95.0|-1.27|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.74|-1.27|0.6005
71750802|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.5284|TWO_SIDED|95.0|-0.68|1.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||1.32|-0.68|0.5284
71750803|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.1111|TWO_SIDED|95.0|-1.82|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Physical Symptoms Score||0.19|-1.82|0.1111
71750804|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1764|TWO_SIDED|95.0|-1.16|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.21|-1.16|0.1764
71750805|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0037|TWO_SIDED|95.0|-1.73|-0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms||-0.34|-1.73|0.0037
71750806|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.3|-0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.92|-2.30|<0.0001
71750807|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.21|-0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.81|-2.21|<0.0001
71750808|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1444|TWO_SIDED|95.0|-1.21|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||0.18|-1.21|0.1444
71835852|NCT03655132|143177032|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for waitlist control group participants only (n=22).|Median Difference (Net)|-5.0||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.54
71835853|NCT03655132|143177032|OTHER||Median Difference (Net)|-1.5||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8) for VACT-CP group.||||.59
71835854|NCT03655132|143177033|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|2.0||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
71835855|NCT03655132|143177033|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.001
71896199|NCT02495077|143314355|SUPERIORITY|||||||0.311|||||||t-test, 2 sided|||||||0.311
71782975|NCT03000439|143065249|OTHER||Difference in percentage|1.96|||||TWO_SIDED|95.0|-23.55|27.47|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 24||27.47|-23.55|
71782976|NCT03000439|143065249|OTHER|The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|Difference in percentage|15.21|||||TWO_SIDED|95.0|-10.05|40.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 28||40.46|-10.05|
71782977|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 32||37.56|-12.91|
71782978|NCT03000439|143065249|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 36||34.33|-16.13|
71782979|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 40||37.56|-12.91|
71668656|NCT02360215|142853779|SUPERIORITY|||||||0.9118|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.9118
71668657|NCT02360215|142853779|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline interference score is reported here.||||<0.0001
71668658|NCT02360215|142853780|SUPERIORITY|||||||0.1964|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.1964
71668659|NCT02360215|142853780|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline cognitive factor score is reported here.||||<0.0001
71668660|NCT02360215|142853780|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Prior radiotherapy (yes vs. no) is reported here.||||0.0032
71668661|NCT02360215|142853781|SUPERIORITY|||||||0.8877|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.||||0.8877
71668662|NCT02360215|142853781|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline neurologic factor is reported here.||||<0.0001
71668663|NCT02360215|142853781|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment\*time, time\*time, time\*time\*time and remained if p\<0.05. Baseline score, treatment arm, and time were forced into the model. Age (\> 61 years vs. \<= 61 years) is reported here.||||0.0078
71782980|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 44||37.56|-12.91|
71782981|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 48||37.56|-12.91|
71782982|NCT03000439|143065249|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR70 at DB Week 52||37.56|-12.91|
71835856|NCT03655132|143177034|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.13
71835857|NCT03655132|143177034|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|3.0||||0.07|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.07
71835858|NCT03655132|143177035|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.0||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.64
71835859|NCT03655132|143177035|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.3||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.30
71835860|NCT03655132|143177036|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|0.5||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.75
71835861|NCT03655132|143177036|OTHER|Wilcoxon Signed Ranks Test comparing baseline score to post-score (approximately Week 8).|Median Difference (Net)|-0.5||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.60
71835862|NCT05568004|143177038|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.|||Statistical analysis was conducted by a researcher using the Statistical Package for Social Sciences (SPSS) version 26.0. The Shapiro-Wilk test and histograms evaluated the data for normal distribution, and the Levene test confirmed homogeneous variances between groups (p \> 0.05). Continuous data following a normal distribution are presented as mean ± standard deviation (SD). The independent samples t test or Mann-Whitney U test was used to compare independent continuous data between groups, while the chi-square or Fisher's exact test was used to compare categorical data. Friedman two-way ANOVA was used to analyze dependent variables, while the two-way mixed ANOVA was used to examine the changes between groups over time. Before the two-way mixed ANOVA, boxplot evaluation confirmed no outliers. Mauchly's sphericity test showed that the assumption of sphericity for two-way interaction was met. Tukey's correction was used for pairwise subgroup comparisons.|||0.001
71835863|NCT05568004|143177038|SUPERIORITY|||||||0.001|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||0.001
71835864|NCT05568004|143177038|SUPERIORITY|||||||0.166||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.166
71835865|NCT05568004|143177039|SUPERIORITY|||||||0.074||||||A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.074
71835866|NCT05568004|143177039|SUPERIORITY|A p-value of \< 0.05 was considered statistically significant for all analyses.Two-tailed testing was used in nature of hypothesis testing.||||||0.074|||||||ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.074
71835867|NCT05568004|143177039|SUPERIORITY|||||||0.311||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p value for change over time within the group, Friedman 2-way ANOVA test was applied.||||||0.311
71835868|NCT05568004|143177040|SUPERIORITY|||||||0.018||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.018
71835869|NCT05568004|143177040|SUPERIORITY|||||||0.152||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.152
71835870|NCT05568004|143177040|SUPERIORITY|||||||0.438||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.438
71835871|NCT05568004|143177041|SUPERIORITY|||||||0.135||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.135
71835872|NCT05568004|143177041|SUPERIORITY|||||||0.203||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.203
71891668|NCT05817045|143304665|SUPERIORITY|SARS-CoV-2 rapid antigen test type: Flowflex|Cox Proportional Hazard|1.46|||||TWO_SIDED|95.0|1.064|1.997|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.997|1.064|
71891669|NCT05817045|143304665|SUPERIORITY|SARS-CoV-2 rapid antigen test type: BinaxNOW|Cox Proportional Hazard|1.12|||||TWO_SIDED|95.0|0.801|1.561|||||For the HR calculation Sham was taken to be the reference group, meaning a HR \> 1 is favorable for RD-X19|Subgroup Analysis - Cox proportional hazards model for time to first of two negative SARS-CoV-2 antigen tests (with a minimum time between tests of six hours) without subsequent virological rebound (during the subject's remaining time on study) (FAS)||1.561|0.801|
71891670|NCT02148029|143304709|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.34|TWO_SIDED|95.0|-1.1|3.1|||t-test, 2 sided||Mean difference = Exercise - Control|||3.1|-1.1|0.34
71750809|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.35||0.0088|TWO_SIDED|95.0|-1.6|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.23|-1.60|0.0088
71750810|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.35||0.0005|TWO_SIDED|95.0|-1.93|-0.54||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Symptoms Score||-0.54|-1.93|0.0005
71750811|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0416|TWO_SIDED|95.0|-0.69|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.01|-0.69|0.0416
71750812|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0353|TWO_SIDED|95.0|-0.71|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.03|-0.71|0.0353
71750813|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.84|-0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.16|-0.84|0.0040
71750814|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0495|TWO_SIDED|95.0|-0.69|0.0||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||-0.00|-0.69|0.0495
71750815|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.8665|TWO_SIDED|95.0|-0.31|0.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.37|-0.31|0.8665
71750816|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9303|TWO_SIDED|95.0|-0.35|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.32|-0.35|0.9303
71750817|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.1039|TWO_SIDED|95.0|-0.62|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Dysfunction Score||0.06|-0.62|0.1039
71750818|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.54||0.2547|TWO_SIDED|95.0|-4.78|1.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.27|-4.78|0.2547
71782983|NCT03000439|143065249|OTHER||Difference in percentage|-19.82|||||TWO_SIDED|95.0|-44.09|4.46|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 4||4.46|-44.09|
71782984|NCT03000439|143065249|OTHER||Difference in percentage|-17.28|||||TWO_SIDED|95.0|-40.19|5.63|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 8||5.63|-40.19|
71835873|NCT05568004|143177041|SUPERIORITY|||||||0.593||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied||||||0.593
71750819|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.6|STANDARD_ERROR_OF_MEAN|1.55||0.0225|TWO_SIDED|95.0|-6.6|-0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.50|-6.60|0.0225
71750820|NCT03192176|143005319|SUPERIORITY||LSMean differencce|-4.3|STANDARD_ERROR_OF_MEAN|1.55||0.0058|TWO_SIDED|95.0|-7.38|-1.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.26|-7.38|0.0058
71782985|NCT03000439|143065249|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 20||14.45|-29.66|
71782986|NCT03000439|143065249|OTHER||Difference in percentage|-13.71|||||TWO_SIDED|95.0|-37.19|9.77|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 12||9.77|-37.19|
71782987|NCT03000439|143065249|OTHER||Difference in percentage|-4.03|||||TWO_SIDED|95.0|-26.67|18.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 16||18.61|-26.67|
71845337|NCT05251363|143204718|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||H0: Improvement in QOL Physical Function Scale ≤ 2.8 Ha: Improvement in QOL Physical Function Scale \> 2.8 Exact one-sample t-test comparing mean improvement in QOL from baseline to 12-mo post-implant to a goal of +2.8. The lower, two-sided 95% confidence bound for the improvement in QOL must be \> +2.8 to reject H0.||||<0.001
71668664|NCT02360215|142853782|SUPERIORITY|||||||0.86||||||Significance level = 0.05|t-test, 2 sided|||||||0.86
71668665|NCT02360215|142853784|SUPERIORITY|||||||0.95||||||Significance level = 0.05|t-test, 2 sided|||||||0.95
71750821|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.56||0.0301|TWO_SIDED|95.0|-6.48|-0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-0.33|-6.48|0.0301
71750822|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.55||0.322|TWO_SIDED|95.0|-4.59|1.51||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||1.51|-4.59|0.3220
71750823|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.54||0.8782|TWO_SIDED|95.0|-2.8|3.27||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||3.27|-2.80|0.8782
71750824|NCT03192176|143005319|SUPERIORITY||LSMean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.55||0.0069|TWO_SIDED|95.0|-7.27|-1.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 4: Total Score||-1.17|-7.27|0.0069
71750825|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.95||0.089|TWO_SIDED|95.0|-3.49|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.25|-3.49|0.0890
71750826|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.95||0.1444|TWO_SIDED|95.0|-3.25|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.48|-3.25|0.1444
71750827|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.1022|TWO_SIDED|95.0|-3.51|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.32|-3.51|0.1022
71750828|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.97||0.2342|TWO_SIDED|95.0|-3.07|0.75||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.75|-3.07|0.2342
71750829|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.96||0.9906|TWO_SIDED|95.0|-1.89|1.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||1.87|-1.89|0.9906
71782988|NCT03000439|143065249|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 32||5.83|-35.32|
71782989|NCT03000439|143065249|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 24||17.26|-26.02|
71835874|NCT05568004|143177042|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
71891671|NCT02148029|143304710|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.5||0.89|TWO_SIDED|95.0|-7.1|8.0|||t-test, 2 sided||Mean difference = Exercise - Control|||8.0|-7.1|0.89
71750830|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.577|TWO_SIDED|95.0|-1.34|2.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||2.40|-1.34|0.5770
71750831|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.95||0.1865|TWO_SIDED|95.0|-3.14|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Symptoms Score||0.61|-3.14|0.1865
71750832|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4575|TWO_SIDED|95.0|-1.45|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.65|-1.45|0.4575
71782990|NCT03000439|143065249|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 28||12.99|-28.89|
71835875|NCT05568004|143177042|SUPERIORITY|||||||0.021||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.021
71896200|NCT02495077|143314356|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||||||0.418
71896201|NCT02495077|143314357|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
71896202|NCT02495077|143314358|SUPERIORITY|||||||0.153|||||||Chi-squared|||||||0.153
71750833|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6016|TWO_SIDED|95.0|-1.33|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.77|-1.33|0.6016
71750834|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7026|TWO_SIDED|95.0|-0.86|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.28|-0.86|0.7026
71750835|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.2971|TWO_SIDED|95.0|-1.64|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.50|-1.64|0.2971
71750836|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.54||0.5491|TWO_SIDED|95.0|-1.38|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.74|-1.38|0.5491
71750837|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.54||0.7142|TWO_SIDED|95.0|-0.86|1.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||1.25|-0.86|0.7142
71750838|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.53||0.1157|TWO_SIDED|95.0|-1.89|0.21||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.21|-1.89|0.1157
71750839|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.36||0.1114|TWO_SIDED|95.0|-1.3|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||0.14|-1.30|0.1114
71782991|NCT03000439|143065249|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 36||16.83|-30.65|
71782992|NCT03000439|143065249|OTHER||Difference in percentage|-3.69|||||TWO_SIDED|95.0|-27.16|19.78|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 40||19.78|-27.16|
71782993|NCT03000439|143065249|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 44||22.68|-23.60|
71782994|NCT03000439|143065249|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 48||22.68|-23.60|
71782995|NCT03000439|143065249|OTHER||Difference in percentage|-0.46|||||TWO_SIDED|95.0|-23.6|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR90 at DB Week 52||22.68|-23.60|
71750840|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.36||0.0025|TWO_SIDED|95.0|-1.83|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.40|-1.83|0.0025
71750841|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.2|-0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Scre||-0.74|-2.20|<0.0001
71782996|NCT03000439|143065249|OTHER||Difference in percentage|-21.2|||||TWO_SIDED|95.0|-42.45|0.05|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 4||0.05|-42.45|
71782997|NCT03000439|143065249|OTHER||Difference in percentage|-18.32|||||TWO_SIDED|95.0|-37.98|1.34|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 8||1.34|-37.98|
71782998|NCT03000439|143065249|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 12||8.61|-31.65|
71782999|NCT03000439|143065249|OTHER||Difference in percentage|-7.95|||||TWO_SIDED|95.0|-28.89|12.99|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 16||12.99|-28.89|
71783000|NCT03000439|143065249|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 20||18.91|-16.15|
71845338|NCT01093612|143204730|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
71668666|NCT02360215|142853785|SUPERIORITY|||||||0.66||||||Significance level = 0.05|t-test, 2 sided|||||||0.66
71668667|NCT02360215|142853786|SUPERIORITY|||||||0.18||||||Significance level = 0.05|t-test, 2 sided|||||||0.18
71845339|NCT01093612|143204731|OTHER||||||<|0.001|||||||Wilcoxon rank-sum|||||||<0.001
71845340|NCT03835754|143204732|OTHER|Confidence internal is 88.8%, upper bound limit 99.2%|Clopper Pearson exact confidence interva|96.0|||||TWO_SIDED|95.0|88.8|99.2||||||||99.2|88.8|
71845341|NCT02921555|143204733|SUPERIORITY||Mean Difference (Final Values)|16.2||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71845342|NCT02921555|143204733|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71750842|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.37||0.5093|TWO_SIDED|95.0|-0.96|0.48|||MMRM|||Week 8: Vasomotor Symptoms Score||0.48|-0.96|0.5093
71750843|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.33|-0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.86|-2.33|<0.0001
71750844|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.36||0.009|TWO_SIDED|95.0|-1.67|-0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Symptoms Score||-0.24|-1.67|0.0090
71750845|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.37||0.0024|TWO_SIDED|95.0|-1.84|-0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 4: Vasomotor Symptoms Score||-0.40|-1.84|0.0024
71750846|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5497|TWO_SIDED|95.0|-0.47|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.25|-0.47|0.5497
71783001|NCT03000439|143065249|OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-21.36|18.37|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 24||18.37|-21.36|
71783002|NCT03000439|143065249|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 28||11.32|-27.91|
71783003|NCT03000439|143065249|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 32||4.10|-34.29|
71783004|NCT03000439|143065249|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 36||8.61|-31.65|
71783005|NCT03000439|143065249|OTHER||Difference in percentage|-7.6|||||TWO_SIDED|95.0|-29.66|14.45|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 40||14.45|-29.66|
71783006|NCT03000439|143065249|OTHER||Difference in percentage|-4.38|||||TWO_SIDED|95.0|-26.02|17.26|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 44||17.26|-26.02|
71783007|NCT03000439|143065249|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 48||21.43|-23.04|
71668668|NCT02360215|142853787|SUPERIORITY|||||||0.64||||||Significance level = 0.05|t-test, 2 sided|||||||0.64
71668669|NCT02360215|142853788|SUPERIORITY|||||||0.91||||||Significance level = 0.05|t-test, 2 sided|||||||0.91
71783008|NCT03000439|143065249|OTHER||Difference in percentage|-0.81|||||TWO_SIDED|95.0|-23.04|21.43|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|ACR100 at DB Week 52||21.43|-23.04|
71668670|NCT02360215|142853789|OTHER|||||||0.92||||||Significance level = 0.05|t-test, 2 sided|||||||0.92
71668671|NCT02360215|142853790|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.076|TWO_SIDED|95.0|0.98|1.47||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantine|||1.47|0.98|0.076
71668672|NCT02360215|142853791|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.242|TWO_SIDED|95.0|0.91|1.43||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantin|||1.43|0.91|0.242
71750847|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0276|TWO_SIDED|95.0|-0.76|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.76|0.0276
71750848|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1274|TWO_SIDED|95.0|-0.65|0.08||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.08|-0.65|0.1274
71750849|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.1865|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|LSMean difference|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1865
71783009|NCT03000439|143065257|OTHER||Difference in percentage|-7.83|||||TWO_SIDED|95.0|-23.42|7.75|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.75|-23.42|
71783010|NCT03000439|143065257|OTHER||Difference in percentage|5.07|||||TWO_SIDED|95.0|-13.94|24.08|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||24.08|-13.94|
71783011|NCT03000439|143065257|OTHER||Difference in percentage|0.81|||||TWO_SIDED|95.0|-21.43|23.04|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.04|-21.43|
71668673|NCT02360215|142853792|SUPERIORITY|||||||0.47||||||Two-sided p-value = 0.05|Chi-squared|||||||0.47
71783012|NCT03000439|143065257|OTHER||Difference in percentage|10.14|||||TWO_SIDED|95.0|-13.82|34.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||34.10|-13.82|
71750850|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1857|TWO_SIDED|95.0|-0.61|0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.12|-0.61|0.1857
71750851|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.8631|TWO_SIDED|95.0|-0.33|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||0.39|-0.33|0.8631
71750852|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0304|TWO_SIDED|95.0|-0.75|-0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Dysfunction Score||-0.04|-0.75|0.0304
71750853|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.63||0.1246|TWO_SIDED|95.0|-5.71|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.70|-5.71|0.1246
71750854|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.63||0.068|TWO_SIDED|95.0|-6.19|0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.22|-6.19|0.0680
71783013|NCT03000439|143065257|OTHER||Difference in percentage|16.24|||||TWO_SIDED|95.0|-8.43|40.92|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||40.92|-8.43|
71783014|NCT03000439|143065257|OTHER||Difference in percentage|9.45|||||TWO_SIDED|95.0|-15.49|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||34.39|-15.49|
71783015|NCT03000439|143065257|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||34.33|-16.13|
71783016|NCT03000439|143065257|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||34.33|-16.13|
71783017|NCT03000439|143065257|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||34.33|-16.13|
71783018|NCT03000439|143065257|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.33|-16.13|
71783019|NCT03000439|143065257|OTHER||Difference in percentage|9.1|||||TWO_SIDED|95.0|-16.13|34.33|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||34.33|-16.13|
71783020|NCT03000439|143065257|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||37.56|-12.91|
71668674|NCT02603146|142853797|OTHER||Cumulative Probability|0.336|||||TWO_SIDED|95.0|0.213|0.459|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for HCQ.|||0.459|0.213|
71783021|NCT03000439|143065257|OTHER||Difference in percentage|12.33|||||TWO_SIDED|95.0|-12.91|37.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||37.56|-12.91|
71783022|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-2.4|2.38||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.38|-2.40|
71783023|NCT03000439|143065263|OTHER||Difference in LS Mean|0.94|||||TWO_SIDED|95.0|-2.25|4.12||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.12|-2.25|
71750855|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.67||0.0729|TWO_SIDED|95.0|-6.28|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.28|-6.28|0.0729
71750856|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.2|STANDARD_ERROR_OF_MEAN|1.66||0.0541|TWO_SIDED|95.0|-6.49|0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||0.06|-6.49|0.0541
71750857|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|95.0|-3.87|2.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||2.59|-3.87|0.6960
71783024|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-4.54|4.06||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.06|-4.54|
71783025|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.86|||||TWO_SIDED|95.0|-3.99|2.28||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.28|-3.99|
71896203|NCT02495077|143314359|SUPERIORITY|||||||0.171|||||||Fisher Exact|||||||0.171
71750858|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.63||0.9725|TWO_SIDED|95.0|-3.27|3.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||3.15|-3.27|0.9725
71750859|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.63||0.0419|TWO_SIDED|95.0|-6.53|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 8: Total Score||-0.12|-6.53|0.0419
71750860|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.96||0.0794|TWO_SIDED|95.0|-3.57|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.20|-3.57|0.0794
71750861|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.98||0.1153|TWO_SIDED|95.0|-3.47|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.38|-3.47|0.1153
71750862|NCT03192176|143005319|SUPERIORITY||-1.5|-1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1334|TWO_SIDED|95.0|-3.47|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.46|-3.47|0.1334
71750863|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.3457|TWO_SIDED|95.0|-2.93|1.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.03|-2.93|0.3457
71750864|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.99||0.2607|TWO_SIDED|95.0|-3.07|0.83||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.83|-3.07|0.2607
71750865|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.97||0.7816|TWO_SIDED|95.0|-2.18|1.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||1.64|-2.18|0.7816
71783026|NCT03000439|143065263|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-3.12|0.94||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-3.12|
71783027|NCT03000439|143065263|OTHER||Difference in LS Mean|0.3|||||TWO_SIDED|95.0|-1.46|2.06||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.06|-1.46|
71783028|NCT03000439|143065263|OTHER||Difference in LS Mean|-1.28|||||TWO_SIDED|95.0|-7.85|5.29||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.29|-7.85|
71750866|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.97||0.0955|TWO_SIDED|95.0|-3.54|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Symptoms Score||0.29|-3.54|0.0955
71750867|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.2582|TWO_SIDED|95.0|-1.57|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.42|-1.57|0.2582
71750868|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.52||0.3448|TWO_SIDED|95.0|-0.53|1.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.52|-0.53|0.3448
71750869|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.6587|TWO_SIDED|95.0|-0.81|1.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.28|-0.81|0.6587
71750870|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8299|TWO_SIDED|95.0|-1.16|0.93||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.93|-1.16|0.8299
71750871|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.53||0.8129|TWO_SIDED|95.0|-1.17|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.92|-1.17|0.8129
71783029|NCT03000439|143065263|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-1.98|2.93||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-1.98|
71750872|NCT03192176|143005319|SUPERIORITY||LSMean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.52||0.213|TWO_SIDED|95.0|-0.37|1.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||1.66|-0.37|0.2130
71845343|NCT03044158|143204764|SUPERIORITY||Rate Ratio (adjusted)|1.56|||||TWO_SIDED|95.0|1.21|2.01||||||||2.01|1.21|
71750873|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4131|TWO_SIDED|95.0|-1.42|0.59||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Physical Symptoms Score||0.59|-1.42|0.4131
71750874|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.1273|TWO_SIDED|95.0|-1.2|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||0.15|-1.20|0.1273
71750875|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.35||0.0046|TWO_SIDED|95.0|-1.69|-0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.31|-1.69|0.0046
71750876|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.19|-0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.80|-2.19|<0.0001
71750877|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.19|-0.78||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.78|-2.19|<0.0001
71750878|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0333|TWO_SIDED|95.0|-1.45|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.06|-1.45|0.0333
71750879|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0423|TWO_SIDED|95.0|-1.39|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.02|-1.39|0.0423
71750880|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0208|TWO_SIDED|95.0|-1.49|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Symptoms Score||-0.12|-1.49|0.0208
71750881|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3435|TWO_SIDED|95.0|-0.55|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.19|-0.55|0.3435
71750882|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.98|-0.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.22|-0.98|0.0021
71750883|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0408|TWO_SIDED|95.0|-0.79|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||-0.02|-0.79|0.0408
71750884|NCT03192176|143005319|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0911|TWO_SIDED|95.0|-0.73|0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.05|-0.73|0.0911
71750885|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7891|TWO_SIDED|95.0|-0.44|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.33|-0.44|0.7891
71750886|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9973|TWO_SIDED|95.0|-0.38|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.38|-0.38|0.9973
71783030|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.86|1.35||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.35|-1.86|
71783031|NCT03000439|143065263|OTHER||Difference in LS Mean|0.73|||||TWO_SIDED|95.0|-2.18|3.63||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.63|-2.18|
71668675|NCT02603146|142853797|OTHER||Cumulative Probability|0.394|||||TWO_SIDED|95.0|0.268|0.519|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 36 for Placebo.|||0.519|0.268|
71668676|NCT02603146|142853797|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.058||||0.522|TWO_SIDED|95.0|-0.336|0.22||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.220|-0.336|0.522
71668677|NCT02603146|142853798|OTHER||Cumulative Probability|0.165|||||TWO_SIDED|95.0|0.076|0.225|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for HCQ.|||0.225|0.076|
71668678|NCT02603146|142853798|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of CL-RA by Month 12 for Placebo.|||0.289|0.099|
71668679|NCT02603146|142853798|SUPERIORITY|"The analysis is based on the KM estimated risk of CL- RA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of CL-RA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.029||||0.668|TWO_SIDED|95.0|-0.188|0.131||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.131|-0.188|0.668
71668680|NCT02603146|142853799|OTHER||Cumulative Probability|0.18|||||TWO_SIDED|95.0|0.088|0.273|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for HCQ.|||0.273|0.088|
71668681|NCT02603146|142853799|OTHER||Cumulative Probability|0.194|||||TWO_SIDED|95.0|0.099|0.289|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 12 for Placebo.|||0.289|0.099|
71668682|NCT02603146|142853799|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 12 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.014||||0.84|TWO_SIDED|95.0|-0.177|0.15||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.150|-0.177|0.840
71668683|NCT02603146|142853800|SUPERIORITY|||||||0.652|||||||Log Rank|||||||0.652
71668684|NCT02603146|142853801|OTHER||Cumulative Probability|0.356|||||TWO_SIDED|95.0|0.23|0.482|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for HCQ.|||0.482|0.230|
71668685|NCT02603146|142853801|OTHER||Cumulative Probability|0.425|||||TWO_SIDED|95.0|0.298|0.551|||||Using Kaplan-Meier product-limit method (and Greenwood's formula for confidence interval), estimated the cumulative probability of development of IA by Month 36 for Placebo.|||0.551|0.298|
71668686|NCT02603146|142853801|SUPERIORITY|"The analysis is based on the KM estimated risk of IA at 36 months, where risk = (1-KM estimated probability of survival). Survival for this analysis is defined as absence of IA. Estimated risks were derived from a Kaplan-Meier curve using censored time-to-event data to account for attrition under the assumption of non-informative censoring."|Risk Difference (RD)|-0.069||||0.452|TWO_SIDED|95.0|-0.363|0.226||The test statistic is a Wald-type chi-square statistic derived by dividing the difference of the logit-transformed KM survival estimates for each arm by the associated variance derived using the delta-method \[Klein, et. al. 2007\].|Chi-squared||Risk difference for HCQ - Placebo|||0.226|-0.363|0.452
71668687|NCT02603146|142853802|SUPERIORITY|||||||0.928||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.928
71668688|NCT02603146|142853802|SUPERIORITY|||||||0.076||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.076
71668689|NCT02603146|142853803|SUPERIORITY|||||||0.781||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.781
71668690|NCT02603146|142853803|SUPERIORITY|||||||0.457||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.457
71668691|NCT02603146|142853804|SUPERIORITY|||||||0.576||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.576
71783032|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.83|||||TWO_SIDED|95.0|-3.22|1.56||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.56|-3.22|
71668692|NCT02603146|142853804|SUPERIORITY|||||||0.323||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.323
71668693|NCT02603146|142853805|SUPERIORITY|||||||0.865||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.865
71668694|NCT02603146|142853805|SUPERIORITY|||||||0.179||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.179
71668695|NCT02603146|142853806|SUPERIORITY|||||||0.634||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.634
71845344|NCT03044158|143204765|SUPERIORITY||Rate Ratio (adjusted)|1.28|||||TWO_SIDED|95.0|0.99|1.66||||||||1.66|0.99|
71668696|NCT02603146|142853806|SUPERIORITY|||||||0.574||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.574
71668697|NCT02603146|142853807|SUPERIORITY|||||||0.724||||||Week 52 results|Wilcoxon (Mann-Whitney)|||||||0.724
71668698|NCT02603146|142853807|SUPERIORITY|||||||0.149||||||Month 36 results|Wilcoxon (Mann-Whitney)|||||||0.149
71668699|NCT02603146|142853811|SUPERIORITY|||||||0.809|||||||Fisher Exact|||||||0.809
71668700|NCT01332487|142853866|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Acute Urinary Retention|Chi-squared|||||||0.002
71668701|NCT01332487|142853866|SUPERIORITY_OR_OTHER|||||||0||95.0||||Surgery|Chi-squared|||||||0.000
71668702|NCT01332487|142853866|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Emergency Surgery|Chi-squared|||||||0.597
71668703|NCT01999920|142853877|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||.064
71835876|NCT05568004|143177042|SUPERIORITY|||||||0.081||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.081
71668704|NCT01999920|142853878|SUPERIORITY||Standard error|5.5|STANDARD_ERROR_OF_MEAN|3.13||0.11|TWO_SIDED|95.0|-1.32|12.32|||Mixed Models Analysis|||||12.32|-1.32|0.11
71835877|NCT05568004|143177043|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||<0.001
71835878|NCT05568004|143177043|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
71835879|NCT05568004|143177043|SUPERIORITY|||||||0.747||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.747
71835880|NCT05568004|143177044|SUPERIORITY|||||||0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|\*p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||Statistical Package for Social Sciences (SPSS) 26.0 package program was used to analyze the data. The suitability of normal distribution of the data was evaluated with Shapiro Wilk and histograms. Numerical data complying with normal distribution are presented as mean±standard deviation (SD). . Friedman 2-way ANOVA was used to analyze dependent variables. Two-way mixed ANOVA test was used to examine the changes between groups over time||||0.001
71835881|NCT05568004|143177044|SUPERIORITY||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||<0.001
71835882|NCT05568004|143177044|SUPERIORITY|||||||0.05||||||A p-value of \< 0.05 was considered statistically significant for all analyses.|ANOVA|p-value for changes over time within the group; Friedman's two-way ANOVA test was applied.||||||0.05
71835883|NCT05919082|143177045|OTHER||Odds Ratio (OR)|1.4||||0.0438|TWO_SIDED|95.0|1.01|1.99|||Regression, Logistic||The odds ratio and p-value are obtained by logistic regression model, adjusted for baseline PGA. Wald CI was presented.|||1.99|1.01|0.0438
71891672|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|7.2||0.43|TWO_SIDED|95.0|-20.3|8.4|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Physical Functioning (PF) domain score.||8.4|-20.3|0.43
71668705|NCT01999920|142853879|SUPERIORITY||Standard error|0.34|STANDARD_ERROR_OF_MEAN|2.44||0.89|TWO_SIDED|95.0|-4.85|5.53|||Mixed Models Analysis|||Confidence variable||5.53|-4.85|0.89
71835884|NCT05919082|143177046|OTHER||Odds Ratio (OR)|1.5||||0.0108|TWO_SIDED|95.0|1.1|2.12|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.12|1.10|0.0108
71835885|NCT05919082|143177047|OTHER||Odds Ratio (OR)|1.5||||0.0199|TWO_SIDED|95.0|1.07|2.19|||Regression, Logistic||The odds ratio and p-value were obtained by logistic regression model, adjusted for baseline PGA and baseline mPASI score. Wald CI was presented.|||2.19|1.07|0.0199
71835886|NCT00274469|143177101|NON_INFERIORITY|Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.|Odds Ratio (OR)|1.302||||0.386|TWO_SIDED|95.0|0.717|2.38||Null hypothesis: Fulvestrant has no difference with Anastrozole|Regression, Logistic||OR\>1 favours Fulvestrant|||2.380|0.717|0.386
71891673|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.3||0.13|TWO_SIDED|95.0|-1.6|11.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to Physical health problems (RP) domain score.||11.6|-1.6|0.13
71668706|NCT01999920|142853879|SUPERIORITY||Standard error|1.18|STANDARD_ERROR_OF_MEAN|4.41||0.79|TWO_SIDED|95.0|-8.21|10.58|||Mixed Models Analysis|||Discomfort with Closeness variable||10.58|-8.21|0.79
71668707|NCT01999920|142853879|SUPERIORITY||Standard error|3.94|STANDARD_ERROR_OF_MEAN|3.79||0.31|TWO_SIDED|95.0|-4.12|12.01|||Mixed Models Analysis|||Relationships as Secondary variable||12.01|-4.12|0.31
71668708|NCT01999920|142853879|SUPERIORITY||Standard error|-2.6|STANDARD_ERROR_OF_MEAN|1.49||0.1|TWO_SIDED|95.0|-5.79|0.58|||Mixed Models Analysis|||Need for Approval variable||0.58|-5.79|0.10
71668709|NCT01999920|142853879|SUPERIORITY||Standard error|0.71|STANDARD_ERROR_OF_MEAN|2.82||0.8|TWO_SIDED|95.0|-5.3|6.72|||Mixed Models Analysis|||Preoccupation with Relationships variable||6.72|-5.30|0.80
71835887|NCT00274469|143177102|SUPERIORITY||Odds Ratio (OR)|1.021||||0.947|TWO_SIDED|95.0|0.556|1.874|||Regression, Logistic||OR\>1 favours Fulvestrant|||1.874|0.556|0.947
71835888|NCT00274469|143177103|SUPERIORITY||Hazard Ratio (HR)|0.6266||||0.0496|TWO_SIDED|95.0|0.3929|0.9991|||Log Rank||HR\<1 favours Fulvestrant|||0.9991|0.3929|0.0496
71835889|NCT00274469|143177104|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.54|1.0|||Log Rank||HR\<1 favours Fulvestrant|||1.00|0.54|0.05
71835890|NCT00274469|143177104|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.52|0.98|||Regression, Cox|Cox regression analysis of TTTF controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.98|0.52|0.04
71835891|NCT00274469|143177105|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.47|0.92|||Log Rank||HR\<1 favours Fulvestrant|||0.92|0.47|0.01
71835892|NCT00274469|143177105|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.46|0.9|||Regression, Cox|Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.|HR\<1 favours Fulvestrant|||0.90|0.46|0.01
71835893|NCT00274469|143177106|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.041|TWO_SIDED|95.0|0.5|0.98|||Log Rank|||||0.98|0.50|0.041
71896204|NCT02495077|143314360|SUPERIORITY|||||||0.163|||||||Chi-squared|||||||0.163
71896205|NCT02495077|143314361|SUPERIORITY|||||||0.572|||||||Chi-squared|||||||0.572
71668710|NCT01999920|142853880|SUPERIORITY||Standard error|-19.91|STANDARD_ERROR_OF_MEAN|6.99||0.008|TWO_SIDED|95.0|-34.23|-5.58|||Mixed Models Analysis|||||-5.58|-34.23|0.008
71668711|NCT01999920|142853881|SUPERIORITY||Standard error|3.29|STANDARD_ERROR_OF_MEAN|1.43||0.026|TWO_SIDED|95.0|0.42|6.16|||Mixed Models Analysis|||||6.16|0.42|0.026
71750887|NCT03192176|143005319|SUPERIORITY||-0.1|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6377|TWO_SIDED|95.0|-0.47|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Dysfunction Score||0.29|-0.47|0.6377
71750888|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.61||0.0862|TWO_SIDED|95.0|-5.95|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.40|-5.95|0.0862
71750889|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.65||0.1305|TWO_SIDED|95.0|-5.74|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.74|-5.74|0.1305
71750890|NCT03192176|143005319|SUPERIORITY||LSMean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.68||0.0707|TWO_SIDED|95.0|-6.34|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.26|-6.34|0.0707
71750891|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.68||0.1232|TWO_SIDED|95.0|-5.92|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.71|-5.92|0.1232
71750892|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.66||0.253|TWO_SIDED|95.0|-5.18|1.37||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||1.37|-5.18|0.2530
71750893|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.64||0.9133|TWO_SIDED|95.0|-3.4|3.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||3.04|-3.40|0.9133
71891674|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.8||0.33|TWO_SIDED|95.0|-2.8|8.2|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Role limitations due to mental health or Emotional problems (RE) domain score.||8.2|-2.8|0.33
71668712|NCT01999920|142853882|SUPERIORITY||Standard error|21.38|STANDARD_ERROR_OF_MEAN|7.65||0.01|TWO_SIDED|95.0|5.64|37.11|||Mixed Models Analysis|||||37.11|5.64|0.01
71668713|NCT01958437|142853917|SUPERIORITY|||||||0.048|||||||ANCOVA|||RM ANCOVA (covarying order) for cognitively intact groups||||.048
71668714|NCT01958437|142853917|SUPERIORITY|||||||0.063|||||||ANCOVA|||RM ANCOVA (covarying order) for MCI group||||.063
71668715|NCT01958437|142853918|SUPERIORITY|||||||0.27|||||||ANCOVA|Main effect of stimulation covarying session order||Change between active and sham tDCS sessions for allocentric blocks||||.27
71668716|NCT01958437|142853918|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
71668717|NCT01958437|142853919|SUPERIORITY||||||<|0.001|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||<.001
71668718|NCT01958437|142853919|SUPERIORITY|||||||0.046|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order||||||.046
71668719|NCT01958437|142853920|SUPERIORITY|||||||0.497|||||||ANCOVA|||Repeated Measures ANCOVA (covarying stimulation order)||||.497
71783033|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.23|||||TWO_SIDED|95.0|-1.76|1.3||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.76|
71896206|NCT02495077|143314362|SUPERIORITY|||||||0.973|||||||Chi-squared|||||||0.973
71668720|NCT01958437|142853920|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||.599
71668721|NCT04886596|142853929|OTHER|VE is demonstrated if the lower limit (LL) of the 2-sided confidence interval (CI) for vaccine efficacy (VE) is above 20%.|VE|82.58|||||TWO_SIDED|96.95|57.89|94.08|||Poisson regression method||VE in terms of occurrence of RSV-confirmed LRTD was evaluated using the conditional exact binomial method based on the Poisson model|To demonstrate the vaccine efficacy (VE) efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD during the first season in adults ≥ 60 YOA||94.08|57.89|
71668722|NCT04886596|142853930|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|62.91|||||TWO_SIDED|97.5|46.74|74.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||74.79|46.74|
71668723|NCT04886596|142853930|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.18|||||TWO_SIDED|97.5|48.19|80.04|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.04|48.19|
71677084|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.41|-7.72||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.72|-17.41|<0.0001
71668724|NCT04886596|142853931|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.76|||||TWO_SIDED|97.5|51.82|79.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over three seasons.||79.11|51.82|
71835894|NCT00274469|143177106|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.126|TWO_SIDED|95.0|0.54|1.08|||Regression, Cox|Cox regression analysis of OS controlling for baseline covariates|HR\<1 favours Fulvestrant|||1.08|0.54|0.126
71668725|NCT04886596|142853931|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 20%.|VE|67.12|||||TWO_SIDED|97.5|48.09|80.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine followed by 1 annual revaccination before Season 2 in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over two seasons.||80.00|48.09|
71668726|NCT04886596|142853932|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|69.83|||||TWO_SIDED|97.5|42.18|85.72|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||85.72|42.18|
71668727|NCT04886596|142853932|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|58.57|||||TWO_SIDED|97.5|35.9|74.11|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||74.11|35.90|
71668728|NCT04886596|142853933|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|55.12|||||TWO_SIDED|97.5|16.52|77.52|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype A in adults ≥ 60 YOA over 3 seasons.||77.52|16.52|
71668729|NCT04886596|142853933|OTHER|VE is demonstrated if the LL of the 2-sided CI for VE is above 0%.|VE|73.58|||||TWO_SIDED|97.5|55.1|85.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To demonstrate the vaccine efficacy of a single dose and 1 annual revaccination before Season 2 of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD for RSV subtype B in adults ≥ 60 YOA over 3 seasons.||85.40|55.10|
71668730|NCT04886596|142853934|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|18.41|||||TWO_SIDED|95.0|-19.1|44.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season)|To evaluate vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hMPV-confirmed LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine up to the end of Season 1.||44.33|-19.10|
71750894|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.6|STANDARD_ERROR_OF_MEAN|1.63||0.1078|TWO_SIDED|95.0|-5.85|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 12: Total Score||0.58|-5.85|0.1078
71750895|NCT03192176|143005319|SUPERIORITY||LSMean differencce|-1.9|STANDARD_ERROR_OF_MEAN|1.08||0.0719|TWO_SIDED|95.0|-4.07|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.18|-4.07|0.0719
71750896|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|1.09||0.1298|TWO_SIDED|95.0|-3.8|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.49|-3.80|0.1298
71750897|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9532|TWO_SIDED|95.0|-2.26|2.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.13|-2.26|0.9532
71750898|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.751|TWO_SIDED|95.0|-1.84|2.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.55|-1.84|0.7510
71750899|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.11||0.112|TWO_SIDED|95.0|-3.95|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.42|-3.95|0.1120
71835895|NCT02910713|143177139|SUPERIORITY||Least Squares Mean Difference|-13.36|STANDARD_ERROR_OF_MEAN|1.999|<|0.0001|TWO_SIDED|95.0|-17.31|-9.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-9.40|-17.31|<0.0001
71845345|NCT03044158|143204766|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.49|||||TWO_SIDED|95.0|0.39|0.62||||||||0.62|0.39|
71668731|NCT04886596|142853935|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.78|||||TWO_SIDED|95.0|40.73|71.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.96|40.73|
71668732|NCT04886596|142853935|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.98|||||TWO_SIDED|95.0|44.32|80.16|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||80.16|44.32|
71668733|NCT04886596|142853935|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|36.24|||||TWO_SIDED|95.0|-93.99|82.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.47|-93.99|
71668734|NCT04886596|142853935|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.56|||||TWO_SIDED|95.0|49.33|78.64|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=65YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.64|49.33|
71668735|NCT04886596|142853935|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.25|||||TWO_SIDED|95.0|40.49|79.55|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=70YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||79.55|40.49|
71668736|NCT04886596|142853935|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|32.81|||||TWO_SIDED|95.0|-108.42|81.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by \>=80YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine at end of season 3.||81.73|-108.42|
71668737|NCT04886596|142853936|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|80.64|||||TWO_SIDED|95.0|55.9|92.73|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||92.73|55.90|
71668738|NCT04886596|142853936|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.39|||||TWO_SIDED|95.0|36.44|77.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||77.70|36.44|
71668739|NCT04886596|142853936|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.15|||||TWO_SIDED|95.0|7.06|71.59|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.59|7.06|
71668740|NCT04886596|142853936|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|54.92|||||TWO_SIDED|95.0|27.85|72.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||72.98|27.85|
71668741|NCT04886596|142853936|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.51|||||TWO_SIDED|95.0|22.35|88.79|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over season 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.79|22.35|
71835896|NCT02910713|143177140|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.8|-0.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA|||||-0.40|-0.80|<0.0001
71668742|NCT04886596|142853937|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.86|||||TWO_SIDED|95.0|57.62|90.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 1 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||90.48|57.62|
71668743|NCT04886596|142853937|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.59|||||TWO_SIDED|95.0|34.0|75.1|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||75.10|34.00|
71668744|NCT04886596|142853937|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|47.91|||||TWO_SIDED|95.0|8.51|71.97|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||71.97|8.51|
71668745|NCT04886596|142853937|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.33|||||TWO_SIDED|95.0|33.59|74.94|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 2 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||74.94|33.59|
71668746|NCT04886596|142853937|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.4|||||TWO_SIDED|95.0|24.64|89.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, and region).|To evaluate the efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD over Year 3 in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||89.08|24.64|
71668747|NCT04886596|142853938|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.75|||||TWO_SIDED|95.0|57.95|89.26|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of a single dose of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 1.||89.26|57.95|
71668748|NCT04886596|142853938|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.63|||||TWO_SIDED|95.0|52.47|77.95|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following a single dose of the RSVPreF3 OA investigational vaccine.||77.95|52.47|
71750900|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.1||0.9781|TWO_SIDED|95.0|-2.13|2.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||2.19|-2.13|0.9781
71750901|NCT03192176|143005319|SUPERIORITY||LSMean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.206|TWO_SIDED|95.0|-3.57|0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Symptoms Score||0.77|-3.57|0.2060
71750902|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.5332|TWO_SIDED|95.0|-1.46|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.76|-1.46|0.5332
71750903|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.4599|TWO_SIDED|95.0|-1.54|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.70|-1.54|0.4599
71750904|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.58||0.4752|TWO_SIDED|95.0|-0.72|1.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.55|-0.72|0.4752
71750905|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.58||0.9051|TWO_SIDED|95.0|-1.21|1.07||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.07|-1.21|0.9051
71845346|NCT03044158|143204767|SUPERIORITY||Rate Ratio (adjusted)|1.48|||||TWO_SIDED|95.0|1.04|2.12||||||||2.12|1.04|
71845347|NCT03044158|143204768|SUPERIORITY||Geometric Mean Ratio (adjusted)|0.35|||||TWO_SIDED|95.0|0.21|0.56||||||||0.56|0.21|
71668749|NCT04886596|142853938|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|46.76|74.11|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following a single dose of the RSVPreF3 OA investigational vaccine.||74.11|46.76|
71668750|NCT04886596|142853938|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.49|||||TWO_SIDED|95.0|52.27|77.86|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.86|52.27|
71668751|NCT04886596|142853938|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.66|||||TWO_SIDED|95.0|51.71|78.34|||Regression, Cox||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (%) = Vaccine Efficacy (Piecewise Cox model with time-varying efficacy - adjusted by age and region).|To evaluate the evolution of efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA over Season 3, following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.34|51.71|
71668752|NCT04886596|142853939|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|66.49|||||TWO_SIDED|95.0|47.54|79.4|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||79.40|47.54|
71677085|NCT00356135|142872621|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|||<|0.0001|TWO_SIDED|95.0|-16.8|-6.82||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.82|-16.80|<0.0001
71750906|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.58||0.9937|TWO_SIDED|95.0|-1.14|1.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.15|-1.14|0.9937
71750907|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.57||0.6956|TWO_SIDED|95.0|-0.91|1.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||1.35|-0.91|0.6956
71750908|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.2302|TWO_SIDED|95.0|-1.81|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Physical Symptoms Score||0.44|-1.81|0.2302
71750909|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.1544|TWO_SIDED|95.0|-1.55|0.25||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.25|-1.55|0.1544
71750910|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6847|TWO_SIDED|95.0|-1.1|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.72|-1.10|0.6847
71750911|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.552|TWO_SIDED|95.0|-1.2|0.64||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.64|-1.20|0.5520
71750912|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3632|TWO_SIDED|95.0|-1.36|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.50|-1.36|0.3632
71750913|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2828|TWO_SIDED|95.0|-1.43|0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.42|-1.43|0.2828
71783034|NCT03000439|143065263|OTHER||Difference in LS Mean|-0.75|||||TWO_SIDED|95.0|-3.43|1.93||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.93|-3.43|
71783035|NCT03000439|143065264|OTHER||Difference in LS Mean|0.9|||||TWO_SIDED|95.0|-1.8|3.61||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.61|-1.80|
71668753|NCT04886596|142853939|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.88|||||TWO_SIDED|95.0|34.81|74.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following a single dose of the RSVPreF3 OA investigational vaccine.||74.98|34.81|
71750914|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4702|TWO_SIDED|95.0|-1.24|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.58|-1.24|0.4702
71750915|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8262|TWO_SIDED|95.0|-1.02|0.81||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Symptoms Score||0.81|-1.02|0.8262
71783036|NCT03000439|143065264|OTHER||Difference in LS Mean|2.11|||||TWO_SIDED|95.0|-0.64|4.86||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.86|-0.64|
71668754|NCT04886596|142853939|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|72.55|||||TWO_SIDED|95.0|54.34|84.37|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with low/medium risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.37|54.34|
71783037|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-4.25|4.21||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.21|-4.25|
71783038|NCT03000439|143065264|OTHER||Difference in LS Mean|-1.12|||||TWO_SIDED|95.0|-4.32|2.09||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.09|-4.32|
71783039|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.53|||||TWO_SIDED|95.0|-3.04|1.98||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.98|-3.04|
71783040|NCT03000439|143065264|OTHER||Difference in LS Mean|1.84|||||TWO_SIDED|95.0|-1.29|4.97||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.97|-1.29|
71783041|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-5.89|5.72||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.72|-5.89|
71783042|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.69|||||TWO_SIDED|95.0|-3.79|2.41||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.41|-3.79|
71783043|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.35|||||TWO_SIDED|95.0|-1.89|1.19||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-1.89|
71783044|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-3.63|3.58||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.58|-3.63|
71783045|NCT03000439|143065264|OTHER||Difference in LS Mean|-2.59|||||TWO_SIDED|95.0|-5.67|0.49||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-5.67|
71783046|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.82|||||TWO_SIDED|95.0|-2.82|1.19||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.19|-2.82|
71783047|NCT03000439|143065264|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-3.27|2.36||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.36|-3.27|
71783048|NCT03000439|143065277|OTHER||Difference in LS Mean|0.86|||||TWO_SIDED|95.0|-0.08|1.79||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.79|-0.08|
71783049|NCT03000439|143065277|OTHER||Difference in LS Mean|1.32|||||TWO_SIDED|95.0|0.25|2.4||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.40|0.25|
71783050|NCT03000439|143065277|OTHER||Difference in LS Mean|1.43|||||TWO_SIDED|95.0|-0.79|3.66||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||3.66|-0.79|
71783051|NCT03000439|143065277|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-0.7|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.74|-0.70|
71668755|NCT04886596|142853939|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.99|||||TWO_SIDED|95.0|37.17|78.01|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA by baseline comorbidities with high risk (Charlson Comorbidity Index), following annual revaccination of the RSVPreF3 OA investigational vaccine.||78.01|37.17|
71668756|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.48|||||TWO_SIDED|95.0|38.62|76.74|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||76.74|38.62|
71668757|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.73|||||TWO_SIDED|95.0|45.1|78.14|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following a single dose of the RSVPreF3 OA investigational vaccine.||78.14|45.10|
71677086|NCT00356135|142872622|SUPERIORITY_OR_OTHER|||||||0.1824|||||||t-test, 2 sided|||The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.||||0.1824
71750916|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3152|TWO_SIDED|95.0|-0.6|0.19||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.19|-0.60|0.3152
71891675|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|7.1||0.43|TWO_SIDED|95.0|-8.7|20.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the energy/fatigue/Vitality (VT) domain score.||20.0|-8.7|0.43
71896207|NCT02495077|143314363|SUPERIORITY|||||||0.152|||||||Chi-squared|||||||0.152
71677087|NCT00356135|142872622|SUPERIORITY_OR_OTHER|||||||0.1101|||||||F-test|||The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.||||0.1101
71750917|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4399|TWO_SIDED|95.0|-0.56|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.56|0.4399
71750918|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1898|TWO_SIDED|95.0|-0.67|0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.13|-0.67|0.1898
71750919|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9791|TWO_SIDED|95.0|-0.4|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.41|-0.40|0.9791
71750920|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3178|TWO_SIDED|95.0|-0.61|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.20|-0.61|0.3178
71750921|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4174|TWO_SIDED|95.0|-0.57|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.24|-0.57|0.4174
71750922|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.249|TWO_SIDED|95.0|-0.63|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Dysfunction Score||0.16|-0.63|0.2490
71783052|NCT03000439|143065277|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.43|0.64||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.64|-0.43|
71783053|NCT03000439|143065277|OTHER||Difference in LS Mean|0.44|||||TWO_SIDED|95.0|0.06|0.81||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.81|0.06|
71783054|NCT03000439|143065277|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.64|2.06||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.06|-1.64|
71783055|NCT03000439|143065277|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.04|1.03||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.03|-0.04|
71677088|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.1||||0.3466|TWO_SIDED|95.0|-9.5|3.37||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||3.37|-9.50|0.3466
71783056|NCT03000439|143065277|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.09|0.79||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.79|-0.09|
71783057|NCT03000439|143065277|OTHER||Difference in LS Mean|0.52|||||TWO_SIDED|95.0|-0.23|1.28||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.28|-0.23|
71783058|NCT03000439|143065277|OTHER||Difference in LS Mean|-0.19|||||TWO_SIDED|95.0|-1.2|0.83||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.83|-1.20|
71783059|NCT03000439|143065277|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.49|0.91||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.91|-0.49|
71783060|NCT03000439|143065277|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.8|0.92||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.92|-0.80|
71783061|NCT03000439|143065278|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.43|1.0||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.00|-0.43|
71783062|NCT03000439|143065278|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|-0.06|2.08||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-0.06|
71783063|NCT03000439|143065278|OTHER||Difference in LS Mean|1.25|||||TWO_SIDED|95.0|-1.13|3.64||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.64|-1.13|
71835897|NCT05386355|143177208|SUPERIORITY||Risk Ratio (RR)|1.79|||||TWO_SIDED|95.0|0.59|5.35|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||5.35|0.59|
71835898|NCT05386355|143177209|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.65|||||The General Health App is the reference group.|A mixed-effect Poisson regression with robust variance estimation was used report the adjusted RR with 95% CI accounting for the clinic-specific random intercepts. Given the small number of COVID-19 vaccination completion, we were unable to account for children nested with parent/caregiver or adjusting for covariates.||1.65|0.42|
71835899|NCT05386355|143177210|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.638|TWO_SIDED|95.0|-1.19|0.73|||Mixed Models Analysis|The analytical method was based on a linear mixed model adjusting for baseline SAGE vaccine hesitancy composite scores and random clinic effect.||||0.73|-1.19|0.638
71835900|NCT04521478|143177215|OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|2.2||0.7636|TWO_SIDED|90.0|-3.0|4.3|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.3|-3.0|0.7636
71835901|NCT04521478|143177215|OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|2.2||0.304|TWO_SIDED|90.0|-1.4|5.9|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.9|-1.4|0.3040
71783064|NCT03000439|143065278|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.68|0.88||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-0.68|
71783065|NCT03000439|143065278|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.58|0.33||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.58|
71783066|NCT03000439|143065278|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.03|0.68||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.68|-0.03|
71783067|NCT03000439|143065278|OTHER||Difference in LS Mean|-0.17|||||TWO_SIDED|95.0|-2.42|2.08||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.08|-2.42|
71783068|NCT03000439|143065278|OTHER||Difference in LS Mean|0.42|||||TWO_SIDED|95.0|-0.14|0.97||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.97|-0.14|
71845348|NCT03044158|143204769|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.35||||||||1.35|0.44|
71896208|NCT02495077|143314364|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71896209|NCT02495077|143314365|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71668758|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|68.14|||||TWO_SIDED|95.0|45.71|82.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.33|45.71|
71668759|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.88|||||TWO_SIDED|95.0|31.35|82.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.48|31.35|
71668760|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.16|||||TWO_SIDED|95.0|41.08|79.17|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with no pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||79.17|41.08|
71668761|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|71.19|||||TWO_SIDED|95.0|51.92|83.65|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing comorbidity of interest, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.65|51.92|
71750923|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.87||0.1233|TWO_SIDED|95.0|-6.57|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||0.79|-6.57|0.1233
71750924|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.2858|TWO_SIDED|95.0|-5.76|1.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.70|-5.76|0.2858
71750925|NCT03192176|143005319|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.93||0.9716|TWO_SIDED|95.0|-3.87|3.73||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.73|-3.87|0.9716
71750926|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|1.93||0.9072|TWO_SIDED|95.0|-3.58|4.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||4.03|-3.58|0.9072
71783069|NCT03000439|143065278|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.15|0.79||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.79|-0.15|
71783070|NCT03000439|143065278|OTHER||Difference in LS Mean|0.68|||||TWO_SIDED|95.0|-0.14|1.49||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.49|-0.14|
71677089|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-33.4|-20.33||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-20.33|-33.40|<0.0001
71750927|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.3|STANDARD_ERROR_OF_MEAN|1.92||0.2334|TWO_SIDED|95.0|-6.07|1.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.49|-6.07|0.2334
71750928|NCT03192176|143005319|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|1.91||0.9859|TWO_SIDED|95.0|-3.79|3.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||3.72|-3.79|0.9859
71750929|NCT03192176|143005319|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.9||0.287|TWO_SIDED|95.0|-5.77|1.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \&TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& an interaction of baseline measurement by week.|MMRM|||Week 15: Total Score||1.72|-5.77|0.2870
71783071|NCT03000439|143065278|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-1.28|0.96||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.96|-1.28|
71896210|NCT02495077|143314366|SUPERIORITY|||||||0.347|||||||Chi-squared|||||||0.347
71835902|NCT04521478|143177215|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.2||0.309|TWO_SIDED|90.0|-1.4|5.7|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.7|-1.4|0.3090
71835903|NCT04521478|143177215|OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.3694|TWO_SIDED|90.0|-1.3|4.4|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline MADRS total score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.4|-1.3|0.3694
71835904|NCT04521478|143177215|OTHER|||||||0.9158|||||||MCPMod Linear model|No parameter assumptions required. Corresponding dose response is linear||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9158
71835905|NCT04521478|143177215|OTHER|||||||0.8676|||||||MCPMod Exponential model|Assumption: 5% of the maximum effect is achieved at 25 mg; corresponding to a drug effect achieved mainly at higher doses||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.8676
71668762|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|75.94|||||TWO_SIDED|95.0|54.11|88.54|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing cardiorespiratory condition,following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.54|54.11|
71668763|NCT04886596|142853940|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|69.85|||||TWO_SIDED|95.0|37.51|87.05|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD in adults ≥ 60 YOA with at least 1 pre-existing endocrinometabolic condition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||87.05|37.51|
71668764|NCT04886596|142853941|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-153.57|||||TWO_SIDED|95.0|-16322.97|88.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||88.00|-16322.97|
71835906|NCT04521478|143177215|OTHER|||||||0.9552|||||||MCPMod Emax1 model|Assumption: 50% of the maximum effect is achieved at 25 mg; corresponding to the assumed true median effective dose (ED50) = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9552
71845349|NCT05080777|143204799|EQUIVALENCE|Group, Time, and Group x Time effect tests were performed using MLM.||||||0.295||||||.P-value shown is based on the Group x Time F statistic used in multilevel modeling (MLM)|Multilevel modeling (MLM)|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.295
71668765|NCT04886596|142853941|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|70.07|||||TWO_SIDED|95.0|43.89|85.33|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.33|43.89|
71668766|NCT04886596|142853941|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|61.04|||||TWO_SIDED|95.0|42.89|74.08|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||74.08|42.89|
71677090|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.3||||0.0127|TWO_SIDED|95.0|-13.04|-1.6||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-1.60|-13.04|0.0127
71750930|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1632|TWO_SIDED|95.0|-1.41|0.24||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.24|-1.41|0.1632
71750931|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.42||0.0045|TWO_SIDED|95.0|-2.03|-0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.38|-2.03|0.0045
71750932|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.42||0.0002|TWO_SIDED|95.0|-2.43|-0.77||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.77|-2.43|0.0002
71750933|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.7|-1.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-1.02|-2.70|<0.0001
71750934|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.8569|TWO_SIDED|95.0|-0.91|0.76||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.76|-0.91|0.8569
71750935|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.42||0.111|TWO_SIDED|95.0|-1.49|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||0.15|-1.49|0.1110
71783072|NCT03000439|143065278|OTHER||Difference in LS Mean|0.37|||||TWO_SIDED|95.0|-0.43|1.16||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.43|
71783073|NCT03000439|143065278|OTHER||Difference in LS Mean|0.24|||||TWO_SIDED|95.0|-0.82|1.3||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.82|
71783074|NCT03000439|143065279|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.07|0.5||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.50|-0.07|
71835907|NCT04521478|143177215|OTHER|||||||0.9619|||||||MCPMod Emax2 model|Assumption: 70% of the maximum effect is achieved at 5 mg; corresponding to a drug effect achieved mainly with low doses, ED50 = 2.14 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9619
71750936|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0187|TWO_SIDED|95.0|-1.83|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Vasomotor Mean Score||-0.17|-1.83|0.0187
71750937|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4972|TWO_SIDED|95.0|-0.73|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.36|-0.73|0.4972
71750938|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2568|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2568
71750939|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2609|TWO_SIDED|95.0|-0.86|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.23|-0.86|0.2609
71750940|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4148|TWO_SIDED|95.0|-0.78|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.32|-0.78|0.4148
71783075|NCT03000439|143065279|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.15|0.32||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.32|-0.15|
71783076|NCT03000439|143065279|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.17|0.28||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.28|-0.17|
71783077|NCT03000439|143065279|OTHER||Difference in LS Mean|0.1|||||TWO_SIDED|95.0|-0.16|0.36||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.16|
71750941|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5575|TWO_SIDED|95.0|-0.38|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.71|-0.38|0.5575
71750942|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1671|TWO_SIDED|95.0|-0.16|0.92||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.92|-0.16|0.1671
71750943|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9462|TWO_SIDED|95.0|-0.57|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Psychological Mean Score||0.53|-0.57|0.9462
71750944|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0699|TWO_SIDED|95.0|-0.91|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.04|-0.91|0.0699
71750945|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0056|TWO_SIDED|95.0|-1.15|-0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.20|-1.15|0.0056
71750946|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1117|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1117
71750947|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0265|TWO_SIDED|95.0|-1.02|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.06|-1.02|0.0265
71750948|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1119|TWO_SIDED|95.0|-0.86|0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.09|-0.86|0.1119
71750949|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.7607|TWO_SIDED|95.0|-0.54|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||0.40|-0.54|0.7607
71783078|NCT03000439|143065279|OTHER||Difference in LS Mean|0.19|||||TWO_SIDED|95.0|-0.01|0.38||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.01|
71783079|NCT03000439|143065279|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-0.12|0.35||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.35|-0.12|
71783080|NCT03000439|143065279|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.18|0.31||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.31|-0.18|
71835908|NCT04521478|143177215|OTHER|||||||0.9507|||||||MCPMod Sigmoid Emax model|Assumption: 50% of the maximum effect is achieved at 25 mg, 90% 75 mg; corresponding to a more flexible model of the assumed true ED50 = 25 mg||The Multiple Comparison Procedures and Modeling (MCPMod) procedure used the estimated values from an MMRM model as input and allowed for simultaneous evaluation of different potential dose response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax), while protecting the overall false positive rate (probability of Type I error) using a one-sided, nominal α level of 10 %.||||0.9507
71835909|NCT04521478|143177216|OTHER||Odds Ratio (OR)|0.9427||||0.8889|TWO_SIDED|90.0|0.4709|1.8873|||Regression, Logistic||5 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.8873|0.4709|0.8889
71750950|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0437|TWO_SIDED|95.0|-0.97|-0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Physical Mean Score||-0.01|-0.97|0.0437
71783081|NCT03000439|143065279|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.06|0.37||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.37|-0.06|
71783082|NCT03000439|143065279|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.14|0.36||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.36|-0.14|
71783083|NCT03000439|143065279|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.06|0.38||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.06|
71783084|NCT03000439|143065279|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.30|-0.22|
71750951|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.35||0.0211|TWO_SIDED|95.0|-1.51|-0.12||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.12|-1.51|0.0211
71750952|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35||0.0017|TWO_SIDED|95.0|-1.82|-0.42||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||-0.42|-1.82|0.0017
71750953|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0598|TWO_SIDED|95.0|-1.37|0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.03|-1.37|0.0598
71750954|NCT03192176|143005320|SUPERIORITY||LSMean differencce|-0.5|STANDARD_ERROR_OF_MEAN|0.36||0.1573|TWO_SIDED|95.0|-1.21|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.20|-1.21|0.1573
71750955|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.7257|TWO_SIDED|95.0|-0.83|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.58|-0.83|0.7257
71750956|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9324|TWO_SIDED|95.0|-0.72|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.66|-0.72|0.9324
71750957|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2172|TWO_SIDED|95.0|-1.14|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Sexual Mean Score||0.26|-1.14|0.2172
71750958|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0742|TWO_SIDED|95.0|-0.88|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.88|0.0742
71750959|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.0035|TWO_SIDED|95.0|-1.16|-0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Score||-0.23|-1.16|0.0035
71750960|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0266|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.06|-0.99|0.0266
71835910|NCT04521478|143177216|OTHER||Odds Ratio (OR)|0.6581||||0.3284|TWO_SIDED|90.0|0.3255|1.3307|||Regression, Logistic||25 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.3307|0.3255|0.3284
71750961|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0124|TWO_SIDED|95.0|-1.06|-0.13||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||-0.13|-1.06|0.0124
71835911|NCT04521478|143177216|OTHER||Odds Ratio (OR)|1.1026||||0.8048|TWO_SIDED|90.0|0.5757|2.1114|||Regression, Logistic||75 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||2.1114|0.5757|0.8048
71835912|NCT04521478|143177216|OTHER||Odds Ratio (OR)|1.0072||||0.982|TWO_SIDED|90.0|0.5968|1.6999|||Regression, Logistic||125 mg BI 1358894 vs Placebo|Logistic regression model, including the fixed categorical effects of treatment and baseline MDD severity.||1.6999|0.5968|0.9820
71750962|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4367|TWO_SIDED|95.0|-0.65|0.28||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.28|-0.65|0.4367
71750963|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9318|TWO_SIDED|95.0|-0.48|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.44|-0.48|0.9318
71750964|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.0714|TWO_SIDED|95.0|-0.89|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 4: Overall Mean Score||0.04|-0.89|0.0714
71750965|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42||0.2027|TWO_SIDED|95.0|-1.35|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.29|-1.35|0.2027
71668767|NCT04886596|142853941|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|13.62|||||TWO_SIDED|95.0|-6751.38|98.91|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||98.91|-6751.38|
71668768|NCT04886596|142853941|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|74.32|||||TWO_SIDED|95.0|49.33|88.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (pre-frail) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||88.31|49.33|
71783085|NCT03000439|143065279|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.38|-0.20|
71783086|NCT03000439|143065279|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.24|0.42||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, open-label baseline value, and open-label baseline value by visit interaction.||0.42|-0.24|
71783087|NCT03000439|143065280|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.1|0.24||||||DB Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.24|-0.10|
71783088|NCT03000439|143065280|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.19|0.15||||||DB Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-0.19|
71783089|NCT03000439|143065280|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-0.19|0.16||||||DB Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.16|-0.19|
71783090|NCT03000439|143065280|OTHER||Difference in LS Mean|0.01|||||TWO_SIDED|95.0|-0.2|0.23||||||DB Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.23|-0.20|
71835913|NCT04521478|143177217|OTHER||Mean Difference (Net)|4.3|STANDARD_ERROR_OF_MEAN|2.6||0.1013|TWO_SIDED|90.0|0.0|8.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.6|0.0|0.1013
71845350|NCT05080777|143204800|EQUIVALENCE|Group, time, and group x time effect tests were performed using multilevel modeling (MLM).||||||0.57||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.570
71668769|NCT04886596|142853941|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|64.79|||||TWO_SIDED|95.0|46.1|77.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed LRTD by baseline frailty status (fit) in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||77.75|46.10|
71677091|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-34.0|||<|0.0001|TWO_SIDED|95.0|-39.99|-28.42||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-28.42|-39.99|<0.0001
71783091|NCT03000439|143065280|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.02|0.32||||||DB Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.32|-0.02|
71783092|NCT03000439|143065280|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.09|0.4||||||DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.09|
71783093|NCT03000439|143065280|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.16|0.34||||||DB Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.34|-0.16|
71783094|NCT03000439|143065280|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.05|0.36||||||DB Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.36|-0.05|
71783095|NCT03000439|143065280|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.1|0.43||||||DB Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.10|
71783096|NCT03000439|143065280|OTHER||Difference in LS Mean|0.17|||||TWO_SIDED|95.0|-0.06|0.39||||||DB Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-0.06|
71668770|NCT04886596|142853942|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
71668771|NCT04886596|142853942|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|67.38|||||TWO_SIDED|95.0|42.43|82.68|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following a single dose of the RSVPreF3 OA investigational vaccine.||82.68|42.43|
71750966|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.41||0.0013|TWO_SIDED|95.0|-2.16|-0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.53|-2.16|0.0013
71750967|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.53|-0.87||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.87|-2.53|<0.0001
71750968|NCT03192176|143005320|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.83|-1.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-1.16|-2.83|<0.0001
71750969|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.3791|TWO_SIDED|95.0|-1.19|0.45||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||0.45|-1.19|0.3791
71750970|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42||0.0211|TWO_SIDED|95.0|-1.78|-0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.15|-1.78|0.0211
71750971|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42||0.0021|TWO_SIDED|95.0|-2.1|-0.47||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Vasomotor Mean Score||-0.47|-2.10|0.0021
71750972|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.889|TWO_SIDED|95.0|-0.55|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Psychological Mean Score||0.48|-0.55|0.8890
71750973|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5568|TWO_SIDED|95.0|-0.67|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.36|-0.67|0.5568
71750974|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3989|TWO_SIDED|95.0|-0.75|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.30|-0.75|0.3989
71750975|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6094|TWO_SIDED|95.0|-0.66|0.39||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.39|-0.66|0.6094
71750976|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5229|TWO_SIDED|95.0|-0.35|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.69|-0.35|0.5229
71750977|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4409|TWO_SIDED|95.0|-0.31|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.72|-0.31|0.4409
71750978|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.8062|TWO_SIDED|95.0|-0.45|0.58||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Psychological Mean Score||0.58|-0.45|0.8062
71891676|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|5.6||0.64|TWO_SIDED|95.0|-13.8|8.6|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Mental Health/emotional well-being (MH) domain score.||8.6|-13.8|0.64
71668772|NCT04886596|142853942|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|59.16|||||TWO_SIDED|95.0|-119.6|95.93|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to the case definition 2, following a single dose of the RSVPreF3 OA investigational vaccine.||95.93|-119.60|
71668773|NCT04886596|142853942|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to any case definition, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
71668774|NCT04886596|142853942|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|78.8|||||TWO_SIDED|95.0|57.05|90.75|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 1, following annual revaccination of the RSVPreF3 OA investigational vaccine.||90.75|57.05|
71677092|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-18.0|||<|0.0001|TWO_SIDED|95.0|-25.58|-11.09||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-11.09|-25.58|<0.0001
71750979|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3663|TWO_SIDED|95.0|-0.71|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.26|-0.71|0.3663
71750980|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0424|TWO_SIDED|95.0|-0.99|-0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||-0.02|-0.99|0.0424
71750981|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.1597|TWO_SIDED|95.0|-0.85|0.14||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.14|-0.85|0.1597
71750982|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.0595|TWO_SIDED|95.0|-0.97|0.02||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.02|-0.97|0.0595
71783097|NCT03000439|143065280|OTHER||Difference in LS Mean|0.04|||||TWO_SIDED|95.0|-0.22|0.3||||||DB Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.30|-0.22|
71783098|NCT03000439|143065280|OTHER||Difference in LS Mean|0.15|||||TWO_SIDED|95.0|-0.18|0.49||||||DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.49|-0.18|
71783099|NCT03000439|143065280|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.23|0.55||||||DB Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.55|-0.23|
71783100|NCT03000439|143065281|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-0.97|1.4||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.40|-0.97|
71783101|NCT03000439|143065281|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.68|1.84||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.84|-0.68|
71783102|NCT03000439|143065281|OTHER||Difference in LS Mean|1.2|||||TWO_SIDED|95.0|-0.77|3.16||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.16|-0.77|
71783103|NCT03000439|143065281|OTHER||Difference in LS Mean|-0.06|||||TWO_SIDED|95.0|-1.3|1.18||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.18|-1.30|
71783104|NCT03000439|143065281|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.29|0.82||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.82|-0.29|
71783105|NCT03000439|143065281|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-0.46|0.64||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.64|-0.46|
71891677|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|-3.9|STANDARD_ERROR_OF_MEAN|8.3||0.64|TWO_SIDED|95.0|-20.5|12.8|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Social Functioning (SF) domain score.||12.8|-20.5|0.64
71750983|NCT03192176|143005320|SUPERIORITY||LSMean differnce|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2162|TWO_SIDED|95.0|-0.8|0.18||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Symptoms Score||0.18|-0.80|0.2162
71750984|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9833|TWO_SIDED|95.0|-0.49|0.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.48|-0.49|0.9833
71750985|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.2034|TWO_SIDED|95.0|-0.81|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Physical Mean Score||0.17|-0.81|0.2034
71750986|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9576|TWO_SIDED|95.0|-0.7|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.67|-0.70|0.9576
71750987|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.041|TWO_SIDED|95.0|-1.4|-0.03||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||-0.03|-1.40|0.0410
71750988|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3961|TWO_SIDED|95.0|-1.0|0.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.40|-1.00|0.3961
71750989|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.5012|TWO_SIDED|95.0|-0.94|0.46||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.46|-0.94|0.5012
71783106|NCT03000439|143065281|OTHER||Difference in LS Mean|-0.46|||||TWO_SIDED|95.0|-2.05|1.13||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.13|-2.05|
71783107|NCT03000439|143065281|OTHER||Difference in LS Mean|0.35|||||TWO_SIDED|95.0|-0.18|0.88||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.18|
71835914|NCT04521478|143177217|OTHER||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|2.6||0.3596|TWO_SIDED|90.0|-1.9|6.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.6|-1.9|0.3596
71677093|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.0|||<|0.0001|TWO_SIDED|95.0|-27.09|-12.26||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-12.26|-27.09|<0.0001
71750990|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.2592|TWO_SIDED|95.0|-1.1|0.3||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.30|-1.10|0.2592
71750991|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6141|TWO_SIDED|95.0|-0.51|0.86||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.86|-0.51|0.6141
71750992|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.439|TWO_SIDED|95.0|-0.95|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Sexual Mean Score||0.41|-0.95|0.4390
71750993|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4521|TWO_SIDED|95.0|-0.64|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.29|-0.64|0.4521
71750994|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0257|TWO_SIDED|95.0|-0.99|-0.06||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||-0.06|-0.99|0.0257
71750995|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0564|TWO_SIDED|95.0|-0.93|0.01||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.01|-0.93|0.0564
71750996|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.0293|TWO_SIDED|95.0|-0.99|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Wek 8: Overall Mean Score||-0.05|-0.99|0.0293
71750997|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3742|TWO_SIDED|95.0|-0.68|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.26|-0.68|0.3742
71750998|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.9106|TWO_SIDED|95.0|-0.49|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean Score||0.44|-0.49|0.9106
71750999|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1844|TWO_SIDED|95.0|-0.78|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 8: Overall Mean SCore||0.15|-0.78|0.1844
71751000|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.0287|TWO_SIDED|95.0|-1.69|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.09|-1.69|0.0287
71751001|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0028|TWO_SIDED|95.0|-2.05|-0.43||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.43|-2.05|0.0028
71751002|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.32|-0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.67|-2.32|0.0004
71751003|NCT03192176|143005320|SUPERIORITY||LSMean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-2.87|-1.22||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-1.22|-2.87|<0.0001
71751004|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1826|TWO_SIDED|95.0|-1.38|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.26|-1.38|0.1826
71751005|NCT03192176|143005320|SUPERIORITY||LSMean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.0178|TWO_SIDED|95.0|-1.79|-0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.17|-1.79|0.0178
71751006|NCT03192176|143005320|SUPERIORITY||LSMean differnce|-1.2|STANDARD_ERROR_OF_MEAN|0.41||0.0025|TWO_SIDED|95.0|-2.06|-0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||-0.44|-2.06|0.0025
71751007|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9163|TWO_SIDED|95.0|-0.55|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.50|-0.55|0.9163
71751008|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.1597|TWO_SIDED|95.0|-0.92|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.15|-0.92|0.1597
71751009|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4871|TWO_SIDED|95.0|-0.74|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.35|-0.74|0.4871
71751010|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5401|TWO_SIDED|95.0|-0.72|0.38||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.38|-0.72|0.5401
71751011|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3788|TWO_SIDED|95.0|-0.3|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.79|-0.30|0.3788
71783108|NCT03000439|143065281|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.26|0.88||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.26|
71751012|NCT03192176|143005320|SUPERIORITY||0.28|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.4541|TWO_SIDED|95.0|-0.33|0.74||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.74|-0.33|0.4541
71751013|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9233|TWO_SIDED|95.0|-0.51|0.56||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Psychological Mean Score||0.56|-0.51|0.9233
71783109|NCT03000439|143065281|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.43|0.99||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||0.99|-0.43|
71783110|NCT03000439|143065281|OTHER||Difference in LS Mean|0.29|||||TWO_SIDED|95.0|-0.45|1.03||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.03|-0.45|
71783111|NCT03000439|143065281|OTHER||Difference in LS Mean|0.22|||||TWO_SIDED|95.0|-0.63|1.08||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.08|-0.63|
71751014|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6043|TWO_SIDED|95.0|-0.61|0.35||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.35|-0.61|0.6043
71751015|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1781|TWO_SIDED|95.0|-0.82|0.15||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.15|-0.82|0.1781
71751016|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5221|TWO_SIDED|95.0|-0.66|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.34|-0.66|0.5221
71783112|NCT03000439|143065281|OTHER||Difference in LS Mean|0.45|||||TWO_SIDED|95.0|-0.66|1.57||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||1.57|-0.66|
71783113|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.13|||||TWO_SIDED|95.0|-0.73|0.47||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.47|-0.73|
71783114|NCT03000439|143065282|OTHER||Difference in LS Mean|0.39|||||TWO_SIDED|95.0|-0.81|1.59||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.59|-0.81|
71783115|NCT03000439|143065282|OTHER||Difference in LS Mean|0.7|||||TWO_SIDED|95.0|-0.54|1.95||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-0.54|
71835915|NCT04521478|143177217|OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|2.5||0.6745|TWO_SIDED|90.0|-5.2|3.1|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||3.1|-5.2|0.6745
71891678|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|10.1||0.35|TWO_SIDED|95.0|-10.7|29.7|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the Bodily Pain (BP) domain score.||29.7|-10.7|0.35
71891679|NCT02148029|143304711|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5|TWO_SIDED|95.0|-14.1|7.0|||t-test, 2 sided||Mean difference = Exercise - Control|Note that this analysis uses only 1 of the 8 SF-36 domain scores, the General Health (GH) domain score.||7.0|-14.1|0.50
71751017|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.4744|TWO_SIDED|95.0|-0.68|0.32||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.32|-0.68|0.4744
71783116|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.10|-0.90|
71783117|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.46|0.13||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.13|-0.46|
71783118|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.32|||||TWO_SIDED|95.0|-0.63|-0.01||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.01|-0.63|
71783119|NCT03000439|143065282|OTHER||Difference in LS Mean|-1.09|||||TWO_SIDED|95.0|-2.34|0.15||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.15|-2.34|
71751018|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5167|TWO_SIDED|95.0|-0.66|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.66|0.5167
71751019|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3441|TWO_SIDED|95.0|-0.25|0.72||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.72|-0.25|0.3441
71751020|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.5362|TWO_SIDED|95.0|-0.64|0.33||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Physical Mean Score||0.33|-0.64|0.5362
71751021|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9349|TWO_SIDED|95.0|-0.78|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.71|-0.78|0.9349
71751022|NCT03192176|143005320|SUPERIORITY||LSMean differencce|-1.0|STANDARD_ERROR_OF_MEAN|0.39||0.0084|TWO_SIDED|95.0|-1.78|-0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||-0.26|-1.78|0.0084
71751023|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.1212|TWO_SIDED|95.0|-1.38|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.16|-1.38|0.1212
71751024|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7709|TWO_SIDED|95.0|-0.89|0.66||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.66|-0.89|0.7709
71751025|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1667|TWO_SIDED|95.0|-1.33|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.23|-1.33|0.1667
71751026|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9213|TWO_SIDED|95.0|-0.72|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.79|-0.72|0.9213
71751027|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.2315|TWO_SIDED|95.0|-1.21|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Sexual Mean Score||0.29|-1.21|0.2315
71751028|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4731|TWO_SIDED|95.0|-0.63|0.29||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.29|-0.63|0.4731
71751029|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.031|TWO_SIDED|95.0|-0.98|-0.05||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||-0.05|-0.98|0.0310
71751030|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.132|TWO_SIDED|95.0|-0.84|0.11||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.11|-0.84|0.1320
71751031|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1212|TWO_SIDED|95.0|-0.85|0.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.10|-0.85|0.1212
71751032|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.5689|TWO_SIDED|95.0|-0.62|0.34||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.34|-0.62|0.5689
71783120|NCT03000439|143065282|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.26|0.4||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.40|-0.26|
71783121|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.02|||||TWO_SIDED|95.0|-0.3|0.26||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.26|-0.30|
71783122|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.53|0.43||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.43|-0.53|
71751033|NCT03192176|143005320|SUPERIORITY||0.1|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.734|TWO_SIDED|95.0|-0.39|0.55||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.55|-0.39|0.7340
71751034|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2704|TWO_SIDED|95.0|-0.73|0.2||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Overall Mean Score||0.20|-0.73|0.2704
71751035|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.561|TWO_SIDED|95.0|-1.24|0.67||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.67|-1.24|0.5610
71751036|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.7966|TWO_SIDED|95.0|-0.83|1.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.09|-0.83|0.7966
71751037|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.3965|TWO_SIDED|95.0|-0.56|1.4||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.40|-0.56|0.3965
71751038|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8189|TWO_SIDED|95.0|-0.87|1.1||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.10|-0.87|0.8189
71751039|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5693|TWO_SIDED|95.0|-1.27|0.7||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 12: Vasomotor Mean Score||0.70|-1.27|0.5693
71751040|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.49||0.5217|TWO_SIDED|95.0|-1.29|0.65||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||0.65|-1.29|0.5217
71751041|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2988|TWO_SIDED|95.0|-0.46|1.48||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Vasomotor Mean Score||1.48|-0.46|0.2988
71783123|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.56|0.46||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.46|-0.56|
71751042|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7957|TWO_SIDED|95.0|-0.69|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.69|0.7957
71751043|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.254|TWO_SIDED|95.0|-0.97|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.26|-0.97|0.2540
71751044|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.6956|TWO_SIDED|95.0|-0.75|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.50|-0.75|0.6956
71751045|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.32||0.8694|TWO_SIDED|95.0|-0.57|0.68||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.68|-0.57|0.8694
71751046|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32||0.5047|TWO_SIDED|95.0|-0.84|0.41||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.41|-0.84|0.5047
71783124|NCT03000439|143065282|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.74|0.69||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.74|
71783125|NCT03000439|143065282|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.91|1.32||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.32|-0.91|
71783126|NCT03000439|143065283|OTHER||Difference in LS Mean|1.01|||||TWO_SIDED|95.0|0.09|1.92||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.92|0.09|
71668775|NCT04886596|142853942|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|20.27|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of severe RSV-confirmed LRTD in adults ≥ 60 YOA according to case definition 2, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|20.27|
71751047|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7515|TWO_SIDED|95.0|-0.52|0.71||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.71|-0.52|0.7515
71751048|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.7818|TWO_SIDED|95.0|-0.7|0.53||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Psychological Mean Score||0.53|-0.70|0.7818
71751049|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.577|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.36|-0.65|0.5770
71751050|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1893|TWO_SIDED|95.0|-0.85|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.17|-0.85|0.1893
71751051|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2997|TWO_SIDED|95.0|-0.25|0.79||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.79|-0.25|0.2997
71751052|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7529|TWO_SIDED|95.0|-0.6|0.44||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.44|-0.60|0.7529
71751053|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4173|TWO_SIDED|95.0|-0.73|0.31||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.31|-0.73|0.4173
71751054|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4944|TWO_SIDED|95.0|-0.34|0.69||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.69|-0.34|0.4944
71751055|NCT03192176|143005320|SUPERIORITY||LSMean differencce|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9231|TWO_SIDED|95.0|-0.54|0.49||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Physical Mean Score||0.49|-0.54|0.9231
71751056|NCT03192176|143005320|SUPERIORITY||LSMean differencce|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.5112|TWO_SIDED|95.0|-1.04|0.52||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.52|-1.04|0.5112
71751057|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.03|TWO_SIDED|95.0|-1.66|-0.09||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||-0.09|-1.66|0.0300
71783127|NCT03000439|143065283|OTHER||Difference in LS Mean|1.31|||||TWO_SIDED|95.0|0.4|2.22||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||2.22|0.40|
71783128|NCT03000439|143065283|OTHER||Difference in LS Mean|0.53|||||TWO_SIDED|95.0|-0.47|1.53||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.53|-0.47|
71835916|NCT04521478|143177217|OTHER||Mean Difference (Net)|2.7|STANDARD_ERROR_OF_MEAN|2.0||0.187|TWO_SIDED|90.0|-0.7|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (S-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.7|0.1870
71835917|NCT04521478|143177217|OTHER||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.0921|TWO_SIDED|90.0|0.1|8.1|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.1|0.1|0.0921
71668776|NCT04886596|142853943|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|51.13|||||TWO_SIDED|95.0|40.31|60.21|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||60.21|40.31|
71751058|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.41||0.0634|TWO_SIDED|95.0|-1.57|0.04||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.04|-1.57|0.0634
71751059|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9406|TWO_SIDED|95.0|-0.78|0.84||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.84|-0.78|0.9406
71751060|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1168|TWO_SIDED|95.0|-1.46|0.16||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.16|-1.46|0.1168
71751061|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9937|TWO_SIDED|95.0|-0.79|0.8||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.80|-0.79|0.9937
71751062|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1858|TWO_SIDED|95.0|-1.32|0.26||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Sexual Mean Score||0.26|-1.32|0.1858
71751063|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.5765|TWO_SIDED|95.0|-0.65|0.36||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.36|-0.65|0.5765
71845351|NCT05080777|143204801|EQUIVALENCE|Group, time, and time x group effect tests were performed using multilevel modeling (MLM).||||||0.461||||||P-value shown is based on the group x time F statistic used in MLM.|MLM|||Null hypothesis was that there would be no group differences, no time differences, and no group x time differences, in changes over time between the two treatment groups. Because this was a pilot and feasibility study, no power calculations were conducted.||||0.461
71751064|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.1848|TWO_SIDED|95.0|-0.86|0.17||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.17|-0.86|0.1848
71751065|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.7299|TWO_SIDED|95.0|-0.43|0.61||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.61|-0.43|0.7299
71751066|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9415|TWO_SIDED|95.0|-0.54|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.54|0.9415
71751067|NCT03192176|143005320|SUPERIORITY||LSMean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2742|TWO_SIDED|95.0|-0.82|0.23||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.23|-0.82|0.2742
71783129|NCT03000439|143065283|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.63|1.16||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.16|-0.63|
71783130|NCT03000439|143065283|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.33|0.97||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.97|-0.33|
71783131|NCT03000439|143065283|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.1|1.2||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.20|-0.10|
71783132|NCT03000439|143065283|OTHER||Difference in LS Mean|0.2|||||TWO_SIDED|95.0|-0.93|1.33||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.33|-0.93|
71783133|NCT03000439|143065283|OTHER||Difference in LS Mean|0.62|||||TWO_SIDED|95.0|-0.17|1.42||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.42|-0.17|
71783134|NCT03000439|143065283|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.02|0.98||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.98|-0.02|
71845352|NCT04649047|143204837|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-2.92||||0.036|TWO_SIDED|95.0|-5.6|-0.23|||t-test, 2 sided|||||-0.23|-5.6|0.036
71668777|NCT04886596|142853943|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|58.44|||||TWO_SIDED|95.0|48.1|66.96|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of RSV-confirmed ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||66.96|48.10|
71751068|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.6946|TWO_SIDED|95.0|-0.41|0.62||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.62|-0.41|0.6946
71751069|NCT03192176|143005320|SUPERIORITY||LSMean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9442|TWO_SIDED|95.0|-0.53|0.5||LSM, SE, CI, \& p-values come from an MMRM model with CFB as dependent variable \& TG, visit \& smoking status as factors \& baseline measurement as a covariate, as well as interaction of treatment by week \& interaction of baseline measurement by week.|MMRM|||Week 15: Overall Mean Score||0.50|-0.53|0.9442
71751070|NCT05108246|143005325|SUPERIORITY|||||||0.001||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.001
71751071|NCT05108246|143005325|SUPERIORITY|||||||0.003||||||P-value is calculated.|Wilcoxon (Mann-Whitney)|||Change in balance was assessed by calculating a change score between pre-test and end point scores for balance. Change scores were then compared using Mann-Whitney U test and reported as Median (Interquartile range).||||.003
71751072|NCT00117637|143005360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.5|TWO_SIDED|95.0|0.61|1.27||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.27|0.61|0.50
71751073|NCT00117637|143005361|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.882||||0.469|TWO_SIDED|95.0|0.628|1.239||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%||1.239|0.628|0.469
71751074|NCT00117637|143005362|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||The Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.006
71751075|NCT00117637|143005363|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||the Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel|||||||0.0004
71751076|NCT00117637|143005365|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.022
71751077|NCT00117637|143005367|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.||||0.015
71751078|NCT00117637|143005369|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.073
71751079|NCT00117637|143005371|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.067
71751080|NCT00117637|143005372|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.005
71751081|NCT00117637|143005373|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.001
71751082|NCT00117637|143005374|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).||||0.019
71751083|NCT00117637|143005383|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Log Rank|||||||0.014
71783135|NCT03000439|143065283|OTHER||Difference in LS Mean|0.64|||||TWO_SIDED|95.0|-0.3|1.58||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.58|-0.30|
71783136|NCT03000439|143065283|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.4|0.85||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.85|-0.40|
71751084|NCT00702468|143005415|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.335||||0.013|TWO_SIDED|90.0|0.162|0.691|||Chi-squared|||||0.691|0.162|0.013
71751085|NCT00702468|143005416|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.21||||0.72|TWO_SIDED|90.0|-1.22|0.79|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|||0.79|-1.22|0.720
71783137|NCT03000439|143065283|OTHER||Difference in LS Mean|0.26|||||TWO_SIDED|95.0|-0.36|0.88||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||0.88|-0.36|
71783138|NCT03000439|143065283|OTHER||Difference in LS Mean|0.11|||||TWO_SIDED|95.0|-0.87|1.09||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-label baseline value, and Open-label baseline value by visit interaction.||1.09|-0.87|
71783139|NCT03000439|143065284|OTHER||Difference in LS Mean|-0.05|||||TWO_SIDED|95.0|-0.77|0.67||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.67|-0.77|
71668778|NCT04886596|142853944|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.33|||||TWO_SIDED|95.0|-1.47|5.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||5.99|-1.47|
71668779|NCT04886596|142853944|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.32|||||TWO_SIDED|95.0|-0.5|6.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any ARI in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||6.98|-0.50|
71668780|NCT04886596|142853944|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|3.68|||||TWO_SIDED|95.0|-1.55|8.63|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||8.63|-1.55|
71751086|NCT00702468|143005417|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.53||||0.86|TWO_SIDED|90.0|-4.68|5.74|||ANCOVA|||||5.74|-4.68|0.86
71751087|NCT00702468|143005419|SUPERIORITY_OR_OTHER_LEGACY||Slope|-1.78||||0.81|TWO_SIDED|90.0|-14.52|10.96|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.||10.96|-14.52|0.81
71751088|NCT00702468|143005420|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.64||||0.271|TWO_SIDED|90.0|-1.6|0.33|||ANCOVA||A negative difference indicates the comparison is in favour of Sativex|||0.33|-1.60|0.271
71783140|NCT03000439|143065284|OTHER||Difference in LS Mean|0.58|||||TWO_SIDED|95.0|-0.37|1.53||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.53|-0.37|
71783141|NCT03000439|143065284|OTHER||Difference in LS Mean|0.12|||||TWO_SIDED|95.0|-1.06|1.3||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-1.06|
71783142|NCT03000439|143065284|OTHER||Difference in LS Mean|-0.26|||||TWO_SIDED|95.0|-1.27|0.74||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.27|
71783143|NCT03000439|143065284|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.83|0.52||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.52|-0.83|
71783144|NCT03000439|143065284|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-0.61|0.71||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.61|
71783145|NCT03000439|143065284|OTHER||Difference in LS Mean|-0.1|||||TWO_SIDED|95.0|-1.45|1.25||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.25|-1.45|
71783146|NCT03000439|143065284|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.61|1.23||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.23|-0.61|
71783147|NCT03000439|143065284|OTHER||Difference in LS Mean|0.18|||||TWO_SIDED|95.0|-0.34|0.71||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.71|-0.34|
71783148|NCT03000439|143065284|OTHER||Difference in LS Mean|0.36|||||TWO_SIDED|95.0|-0.74|1.46||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.46|-0.74|
71677094|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-28.42|-14.77||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-14.77|-28.42|<0.0001
71751089|NCT00702468|143005421|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.562||||0.017|TWO_SIDED|90.0|1.585|13.997|||Regression, Logistic|||||13.997|1.585|0.017
71751090|NCT00702468|143005422|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.55||||0.0011|TWO_SIDED|90.0|3.942|118.773|||Regression, Logistic|||||118.773|3.942|0.0011
71751091|NCT00702468|143005423|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.444||||0.1151|TWO_SIDED|90.0|0.948|13.718|||Regression, Logistic|||||13.718|0.948|0.1151
71783149|NCT03000439|143065284|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.75|0.56||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.56|-0.75|
71783150|NCT03000439|143065284|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.68|0.81||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.81|-0.68|
71835918|NCT04521478|143177217|OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.4||0.7395|TWO_SIDED|90.0|-3.2|4.8|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||4.8|-3.2|0.7395
71835919|NCT04521478|143177217|OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|2.4||0.6296|TWO_SIDED|90.0|-2.7|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-2.7|0.6296
71835920|NCT04521478|143177217|OTHER||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|1.9||0.0429|TWO_SIDED|90.0|0.7|6.9|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of baseline score (T-Anxiety scale). Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.9|0.7|0.0429
71835921|NCT04521478|143177218|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6211|TWO_SIDED|90.0|-0.3|0.5|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.5|-0.3|0.6211
71835922|NCT04521478|143177218|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.5158|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.5158
71751092|NCT04864249|143005453|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71751093|NCT04864249|143005454|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71751094|NCT04864249|143005455|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
71835923|NCT04521478|143177218|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4518|TWO_SIDED|90.0|-0.2|0.6|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.2|0.4518
71835924|NCT04521478|143177218|OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2347|TWO_SIDED|90.0|-0.1|0.6|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||0.6|-0.1|0.2347
71677095|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-29.61|-15.63||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-15.63|-29.61|<0.0001
71751095|NCT04864249|143005456|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71751096|NCT04864249|143005457|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
71751097|NCT04864249|143005458|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
71751098|NCT04864249|143005459|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71751099|NCT04864249|143005460|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71751100|NCT04864249|143005461|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71751101|NCT04864249|143005462|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
71751102|NCT04864249|143005463|SUPERIORITY|||||||0.19|||||||Chi-squared|||||||0.19
71751103|NCT04864249|143005464|SUPERIORITY|||||||0.66|||||||Chi-squared|||||||0.66
71751104|NCT04864249|143005465|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71751105|NCT04864249|143005466|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71751106|NCT04864249|143005467|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
71751107|NCT04864249|143005468|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71751108|NCT04864249|143005469|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||||||0.48
71751109|NCT04864249|143005470|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71751110|NCT04864249|143005471|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
71751111|NCT04864249|143005472|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71751112|NCT04864249|143005473|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71751113|NCT04864249|143005474|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71783151|NCT03000439|143065284|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.1|0.94||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.94|-1.10|
71783152|NCT03000439|143065285|OTHER||Difference in LS Mean|-1.46|||||TWO_SIDED|95.0|-14.59|11.66||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||11.66|-14.59|
71783153|NCT03000439|143065285|OTHER||Difference in LS Mean|-7.22|||||TWO_SIDED|95.0|-19.62|5.17||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.17|-19.62|
71783154|NCT03000439|143065285|OTHER||Difference in LS Mean|-6.61|||||TWO_SIDED|95.0|-19.36|6.14||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||6.14|-19.36|
71751114|NCT04864249|143005475|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71751115|NCT04864249|143005476|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71751116|NCT04864249|143005477|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71751117|NCT04864249|143005478|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71751118|NCT04864249|143005479|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71783155|NCT03000439|143065285|OTHER||Difference in LS Mean|-8.5|||||TWO_SIDED|95.0|-20.28|3.27||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||3.27|-20.28|
71783156|NCT03000439|143065285|OTHER||Difference in LS Mean|-3.95|||||TWO_SIDED|95.0|-10.53|2.62||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.62|-10.53|
71783157|NCT03000439|143065285|OTHER||Difference in LS Mean|-1.44|||||TWO_SIDED|95.0|-8.09|5.21||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||5.21|-8.09|
71783158|NCT03000439|143065285|OTHER||Difference in LS Mean|-4.32|||||TWO_SIDED|95.0|-16.67|8.03||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.03|-16.67|
71783159|NCT03000439|143065285|OTHER||Difference in LS Mean|-2.86|||||TWO_SIDED|95.0|-13.97|8.25||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.25|-13.97|
71751119|NCT04864249|143005480|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71751120|NCT04864249|143005481|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71751121|NCT04864249|143005482|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71751122|NCT04864249|143005483|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71751123|NCT04864249|143005484|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71751124|NCT04864249|143005485|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71751125|NCT04864249|143005486|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71751126|NCT04864249|143005487|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71751127|NCT04864249|143005488|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71751128|NCT00300755|143005489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||<0.001
71751129|NCT00300755|143005489|SUPERIORITY_OR_OTHER|||||||0.063|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||0.063
71751130|NCT00300755|143005489|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.||||< 0.001
71751131|NCT00300755|143005489|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.004
71751132|NCT00300755|143005489|SUPERIORITY_OR_OTHER|||||||0.082|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.082
71751133|NCT00300755|143005489|SUPERIORITY_OR_OTHER|||||||0.217|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.||||0.217
71751134|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.002
71751135|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.033|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.||||0.033
71751136|NCT00300755|143005490|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||<0.001
71751137|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.||||0.002
71783160|NCT03000439|143065285|OTHER||Difference in LS Mean|-10.95|||||TWO_SIDED|95.0|-24.63|2.73||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.73|-24.63|
71783161|NCT03000439|143065285|OTHER||Difference in LS Mean|-4.28|||||TWO_SIDED|95.0|-16.74|8.18||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||8.18|-16.74|
71783162|NCT03000439|143065285|OTHER||Difference in LS Mean|-8.32|||||TWO_SIDED|95.0|-15.2|-1.43||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||-1.43|-15.20|
71751138|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Refusal to eat.||||0.009
71751139|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.004
71751140|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.044|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.||||0.044
71751141|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.002
71751142|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
71751143|NCT00300755|143005490|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.||||0.026
71751144|NCT00300755|143005491|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Cough without cold.||||0.004
71751145|NCT00300755|143005491|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Noisy breathing.||||0.047
71751146|NCT03192826|143005493|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71751147|NCT03192826|143005494|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71751148|NCT03192826|143005495|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71751149|NCT03192826|143005496|EQUIVALENCE|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|||||<0.05
71751150|NCT02694744|143005497|OTHER||||||||||||||||||If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.|||
71751151|NCT02694744|143005498|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7893|TWO_SIDED|95.0|-0.17|0.22|||ANCOVA|||Estimation of mean change in serum potassium from Baseline to week 4.||0.22|-0.17|0.7893
71751152|NCT02174731|143005526|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% confidence interval (CI) of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|0.01|0.18|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean changes.|||0.18|0.01|<0.001
71751153|NCT02174731|143005527|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.056|<|0.001|TWO_SIDED|95.0|0.03|0.25|||MMRM||Difference between groups (roxadustat minus Epoetin alfa) in LS mean change.|||0.25|0.03|<0.001
71751154|NCT02174731|143005528|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.0|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|0.00|<0.001
71751155|NCT02174731|143005529|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.014|<|0.001|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.05|-0.01|<0.001
71751156|NCT02174731|143005530|SUPERIORITY|Superiority was also declared as the lower bound of the 95% CI exceeded 0 and p-value was lower than 0.05.|Least Square Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|-0.39|-0.27|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||-0.27|-0.39|<0.001
71751157|NCT02174731|143005531|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.081|<|0.001|TWO_SIDED|95.0|0.04|0.36|||ANCOVA|MAR-based multiple imputation.|Difference between groups (roxadustat minus Epoetin alfa) in LS mean.|||0.36|0.04|<0.001
71751158|NCT02174731|143005532|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||||||<0.0001
71751159|NCT02174731|143005533|NON_INFERIORITY|Non-inferiority of roxadustat versus epoetin alfa was declared if the upper bound of the HR 95% CI of the difference between roxadustat and epoetin alfa was less than or equal to 1.8. Non-inferiority p-value is 1-sided. The CIs were from Wald and ties were calculated using the Efron method.|Hazard Ratio (HR)|0.83|||<|0.001|TWO_SIDED|95.0|0.64|1.07|||Regression, Cox|||||1.07|0.64|<0.001
71783163|NCT03000439|143065285|OTHER||Difference in LS Mean|-4.84|||||TWO_SIDED|95.0|-12.6|2.92||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.92|-12.60|
71783164|NCT03000439|143065285|OTHER||Difference in LS Mean|-1.34|||||TWO_SIDED|95.0|-5.16|2.48||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open label baseline value, and Open-label baseline value by visit interaction.||2.48|-5.16|
71783165|NCT03000439|143065286|OTHER||Difference in LS Mean|-6.05|||||TWO_SIDED|95.0|-16.3|4.19||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.19|-16.30|
71783166|NCT03000439|143065286|OTHER||Difference in LS Mean|-10.46|||||TWO_SIDED|95.0|-21.68|0.77||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.77|-21.68|
71783167|NCT03000439|143065286|OTHER||Difference in LS Mean|-10.86|||||TWO_SIDED|95.0|-23.75|2.03||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.03|-23.75|
71783168|NCT03000439|143065286|OTHER||Difference in LS Mean|-13.15|||||TWO_SIDED|95.0|-25.83|-0.46||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.46|-25.83|
71783169|NCT03000439|143065286|OTHER||Difference in LS Mean|-7.02|||||TWO_SIDED|95.0|-13.56|-0.47||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.47|-13.56|
71835925|NCT04521478|143177219|OTHER||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.1723|TWO_SIDED|90.0|-0.7|7.6|||Mixed Models Analysis||Difference = (adjusted mean 5 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||7.6|-0.7|0.1723
71835926|NCT04521478|143177219|OTHER||Mean Difference (Net)|4.4|STANDARD_ERROR_OF_MEAN|2.5||0.0757|TWO_SIDED|90.0|0.3|8.5|||Mixed Models Analysis||Difference = (adjusted mean 25 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||8.5|0.3|0.0757
71835927|NCT04521478|143177219|OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.4||0.6864|TWO_SIDED|90.0|-3.0|5.0|||Mixed Models Analysis||Difference = (adjusted mean 75 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||5.0|-3.0|0.6864
71891680|NCT02148029|143304712|SUPERIORITY||Mean Difference (Net)|-33.9|STANDARD_ERROR_OF_MEAN|30.1||0.27|TWO_SIDED|95.0|-95.5|27.7|||t-test, 2 sided||Mean difference = Exercise - Control|||27.7|-95.5|0.27
71668781|NCT04886596|142853944|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.99|||||TWO_SIDED|95.0|1.81|11.9|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of any LRTD in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||11.90|1.81|
71783170|NCT03000439|143065286|OTHER||Difference in LS Mean|-4.53|||||TWO_SIDED|95.0|-11.0|1.95||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.95|-11.00|
71783171|NCT03000439|143065286|OTHER||Difference in LS Mean|-9.35|||||TWO_SIDED|95.0|-22.24|3.54||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.54|-22.24|
71783172|NCT03000439|143065286|OTHER||Difference in LS Mean|-6.75|||||TWO_SIDED|95.0|-18.34|4.83||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.83|-18.34|
71783173|NCT03000439|143065286|OTHER||Difference in LS Mean|-15.49|||||TWO_SIDED|95.0|-30.36|-0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-0.63|-30.36|
71783174|NCT03000439|143065286|OTHER||Difference in LS Mean|-7.99|||||TWO_SIDED|95.0|-21.0|5.03||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.03|-21.00|
71783175|NCT03000439|143065286|OTHER||Difference in LS Mean|-10.49|||||TWO_SIDED|95.0|-17.67|-3.31||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||-3.31|-17.67|
71783176|NCT03000439|143065286|OTHER||Difference in LS Mean|-5.93|||||TWO_SIDED|95.0|-13.53|1.67||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.67|-13.53|
71783177|NCT03000439|143065286|OTHER||Difference in LS Mean|-2.57|||||TWO_SIDED|95.0|-6.37|1.24||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.24|-6.37|
71891681|NCT02148029|143304713|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.07|TWO_SIDED|95.0|-3.4|0.1|||t-test, 2 sided||Mean difference = Reflux - No reflux|||0.1|-3.4|0.07
71783178|NCT03000439|143065287|OTHER||Difference in LS Mean|0.51|||||TWO_SIDED|95.0|0.2|2.22||||||DB week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||2.22|0.20|
71783179|NCT03000439|143065287|OTHER||Difference in LS Mean|0.82|||||TWO_SIDED|95.0|-0.2|1.85||||||DB week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.85|-0.20|
71783180|NCT03000439|143065287|OTHER||Difference in LS Mean|0.31|||||TWO_SIDED|95.0|-0.65|1.27||||||DB week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-0.65|
71783181|NCT03000439|143065287|OTHER||Difference in LS Mean|0.57|||||TWO_SIDED|95.0|-0.26|1.41||||||DB week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.41|-0.26|
71751160|NCT02374164|143005625|SUPERIORITY_OR_OTHER||Point Estimate|0.72|||||TWO_SIDED|90.0|0.612|0.847|||||Ratio Fed/Fasted. Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural logarithm-transformed data. Bioequivalence was reached if the value was 0.80 to 1.25.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in the fasted and fed (high-fat meal) states.||0.847|0.612|
71751161|NCT04678115|143005648|OTHER|Power Calculation: Sample size was estimated based on the treatment condition (three-level factor) effect size on the spontaneous blink IPF measurements (0.55) after eight participants had completed the crossover using one-way analysis of variance power calculation. This led to a sample size of 12 participants with power of 0.80 and type II error of alpha 0.05. To account for possible attrition, 16 were enrolled, with 15 completing the crossover.|||||<|0.001||||||a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|||Linear mixed-effects regression was used to determine the effect of treatment condition on the spontaneous blink and resting state open IPF, with participant as random intercept. Covariates of age, gender, blink sequence, and crossover order were investigated alone, and significant (P \< 0.05) covariates were included in the final model, from which the estimated marginal means and their 95% confidence interval were reported. Hypothesis: MLP allows a more complete spontaneous blink.||||<0.001
71783182|NCT03000439|143065287|OTHER||Difference in LS Mean|0.16|||||TWO_SIDED|95.0|-0.78|1.1||||||DB week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.10|-0.78|
71783183|NCT03000439|143065287|OTHER||Difference in LS Mean|0.66|||||TWO_SIDED|95.0|-0.18|1.49||||||DB week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.49|-0.18|
71783184|NCT03000439|143065287|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.43|1.27||||||DB week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.27|-1.43|
71783185|NCT03000439|143065287|OTHER||Difference in LS Mean|-0.07|||||TWO_SIDED|95.0|-0.65|0.5||||||DB week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.65|
71783186|NCT03000439|143065287|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.51|0.63||||||DB week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.63|-0.51|
71783187|NCT03000439|143065287|OTHER||Difference in LS Mean|-0.04|||||TWO_SIDED|95.0|-0.55|0.47||||||DB week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.47|-0.55|
71783188|NCT03000439|143065287|OTHER||Difference in LS Mean|-0.16|||||TWO_SIDED|95.0|-0.82|0.5||||||DB week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.50|-0.82|
71783189|NCT03000439|143065287|OTHER||Difference in LS Mean|-0.14|||||TWO_SIDED|95.0|-1.51|1.22||||||DB week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||1.22|-1.51|
71783190|NCT03000439|143065287|OTHER||Difference in LS Mean|-0.08|||||TWO_SIDED|95.0|-1.05|0.88||||||DB week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Open-Label baseline value, and Open-Label baseline value by visit interaction.||0.88|-1.05|
71783191|NCT03000439|143065288|OTHER||Difference in LS Mean|0.49|||||TWO_SIDED|95.0|-0.32|1.3||||||DB at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.30|-0.32|
71783192|NCT03000439|143065288|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.64|1.61||||||DB at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.61|-0.64|
71783193|NCT03000439|143065288|OTHER||Difference in LS Mean|0.03|||||TWO_SIDED|95.0|-1.02|1.07||||||DB at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.07|-1.02|
71783194|NCT03000439|143065288|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.69|1.14||||||DB at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.69|
71783195|NCT03000439|143065288|OTHER||Difference in LS Mean|0.09|||||TWO_SIDED|95.0|-1.05|1.22||||||DB at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.22|-1.05|
71783196|NCT03000439|143065288|OTHER||Difference in LS Mean|0.28|||||TWO_SIDED|95.0|-0.6|1.16||||||DB at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.16|-0.60|
71668782|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
71668783|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|50.37|||||TWO_SIDED|95.0|-184.45|95.19|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||95.19|-184.45|
71668784|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
71668785|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|11.56|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|11.56|
71668786|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV seson in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
71751162|NCT04678115|143005649|OTHER|||||||0.001|||||||Mixed Models Analysis|||Hypothesis was that both devices (MLP and KFTS) would open the eye equally well, and that both would be better than sham treatment.||||0.001
71751163|NCT04678115|143005650|OTHER|||||||0.001|||||||test of proportionality|||A test of proportionality was performed to determine the effect of the three treatments on the probability of the eyelid not fully closing.||||0.001
71751164|NCT01168349|143005654|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55|||||TWO_SIDED|95.0|0.42|0.71||||||||0.71|0.42|
71751165|NCT01168349|143005657|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71751166|NCT03535974|143005684|OTHER||Mean Difference (Final Values)|10.57|STANDARD_ERROR_OF_MEAN|5.122||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71751167|NCT00844376|143005686|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.77||||||90.0|85.82|106.88|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUC48 was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUC48; restricted (residual) maximum likelihood (REML) method of estimation.||106.88|85.82|
71751168|NCT00844376|143005687|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|95.04||||||90.0|84.99|106.27|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUCinf||106.27|84.99|
71668787|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|22.14|||||TWO_SIDED|95.0|-457.67|93.12|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||93.12|-457.67|
71751169|NCT00844376|143005688|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|94.86||||||90.0|83.86|107.29|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUClast||107.29|83.86|
71751170|NCT00844376|143005689|SUPERIORITY_OR_OTHER_LEGACY||ratio of adjusted geometric means|117.9||||||90.0|98.22|141.53|||Mixed Models Analysis|The mixed effects model was implemented using SAS Proc Mixed, with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for Cmax||141.53|98.22|
71783197|NCT03000439|143065288|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
71783198|NCT03000439|143065288|OTHER||Difference in LS Mean|0.02|||||TWO_SIDED|95.0|-1.6|1.64||||||DB at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.64|-1.60|
71783199|NCT03000439|143065288|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.58|0.73||||||DB at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.73|-0.58|
71783200|NCT03000439|143065288|OTHER||Difference in LS Mean|0.06|||||TWO_SIDED|95.0|-0.53|0.65||||||DB at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.65|-0.53|
71783201|NCT03000439|143065288|OTHER||Difference in LS Mean|-0.12|||||TWO_SIDED|95.0|-0.87|0.64||||||DB at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.64|-0.87|
71783202|NCT03000439|143065288|OTHER||Difference in LS Mean|0.21|||||TWO_SIDED|95.0|-1.13|1.54||||||DB at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.54|-1.13|
71835928|NCT04521478|143177219|OTHER||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.1585|TWO_SIDED|90.0|-0.5|6.0|||Mixed Models Analysis||Difference = (adjusted mean 125 mg BI 1358894) - (adjusted mean Placebo)|Adjusted means and confidence intervals were estimated using REML-based MMRM including the fixed categorical effects of treatment, concomitant psychotherapy use (yes vs. no), and the fixed continuous effect of the baseline score. Visit was treated as a repeated measure with an unstructured covariance matrix. The Kenward-Roger approximation was used to estimate the denominator degrees of freedom and adjust standard errors.||6.0|-0.5|0.1585
71835929|NCT03775109|143177228|SUPERIORITY||Mean Difference (Net)|16.7||||0.248|TWO_SIDED|95.0|-11.2|44.5||The threshold for statistical significance was p = 0.05|Chi-squared||Difference = Canakinumab - Placebo|It is estimated that improvement of histological alcoholic steatohepatitis will occur in 40% of patients treated with placebo and 80% of patients treated with Canakinumab. A trial with 80% power to detect a difference at the P \< 0.05 threshold would require 23 patients in each arm, 46 in total. Assuming a drop-out rate of 10%, we will recruit 52 patients in total (26 patients per group).||44.5|-11.2|0.248
71835930|NCT03775109|143177229|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
71751171|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.88|1.08|||ANOVA|||Anti-HPV 6||1.08|0.88|<0.001
71751172|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.97|||<|0.001|TWO_SIDED|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11||1.07|0.87|<0.001
71751173|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||ANOVA|||Anti-HPV 16||1.09|0.89|<0.001
71751174|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.12|||ANOVA|||Anti-HPV 18||1.12|0.88|<0.001
71751175|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.04|||<|0.001|TWO_SIDED|95.0|0.93|1.17|||ANOVA|||Anti-HPV 31||1.17|0.93|<0.001
71751176|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||ANOVA|||Anti-HPV 33||1.11|0.89|<0.001
71751177|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|1.1|||<|0.001|TWO_SIDED|95.0|0.97|1.25|||ANOVA|||Anti-HPV 45||1.25|0.97|<0.001
71783203|NCT03000439|143065288|OTHER||Difference in LS Mean|0.05|||||TWO_SIDED|95.0|-1.0|1.11||||||DB at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.11|-1.00|
71783204|NCT03000439|143065291|OTHER||Difference in LS Mean|6.0|||||TWO_SIDED|95.0|-8.35|20.36||||||CHQ01-Global Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||20.36|-8.35|
71783205|NCT03000439|143065291|OTHER||Difference in LS Mean|2.85|||||TWO_SIDED|95.0|-12.43|18.14||||||CHQ01-Global Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.14|-12.43|
71835931|NCT03775109|143177230|SUPERIORITY||Odds Ratio (OR)|3.133|||||TWO_SIDED|95.0|0.121|81.004||||||||81.004|0.121|
71835932|NCT03775109|143177231|SUPERIORITY||Odds Ratio (OR)|1.887|||||TWO_SIDED|95.0|0.357|9.965||||||||9.965|0.357|
71835933|NCT03775109|143177234|SUPERIORITY|||||||0.27|||||||ANCOVA|Change in log-transformed serum bilirubin from baseline to day 28. 49 participants were included in this analysis.||||||0.270
71835934|NCT03775109|143177235|SUPERIORITY|||||||0.0349|||||||ANCOVA|ANCOVA model: MELD score at Day 28 = intercept + treatment group indicator + baseline MELD score. 49 patients have data at Day 28 and baseline.||||||0.03490
71668788|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
71668789|NCT04886596|142853945|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|100.0|||||TWO_SIDED|95.0|-54.53|100.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to RT-PCR-confirmed RSV respiratory disease or complication related to RT-PCR-confirmed RSV ARI during the RSV season in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||100.00|-54.53|
71668790|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.81|||||TWO_SIDED|95.0|-25.43|17.49|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||17.49|-25.43|
71668791|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-4.72|||||TWO_SIDED|95.0|-28.26|14.61|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||14.61|-28.26|
71751178|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 52||1.10|0.88|<0.001
71751179|NCT00988884|143005718|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is \>0.5|Fold difference in GMT|0.99|||<|0.001|TWO_SIDED|95.0|0.88|1.1|||ANOVA|||Anti-HPV 58||1.10|0.88|<0.001
71751180|NCT00988884|143005719|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|3.8|||<|0.001|TWO_SIDED|97.5|-1.7|9.3|||Miettinen and Nurminen|||Serogroup A||9.3|-1.7|<0.001
71751181|NCT00988884|143005719|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-5.4|1.1|||Miettinen and Nurminen|||Serogroup C||1.1|-5.4|<0.001
71751182|NCT00988884|143005719|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|2.1|||<|0.001|TWO_SIDED|97.5|-1.8|6.1|||Miettinen and Nurminen|||Serogroup Y||6.1|-1.8|<0.001
71751183|NCT00988884|143005719|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|TWO_SIDED|97.5|-4.7|0.3|||Miettinen and Nurminen|||Serogroup W-135||0.3|-4.7|<0.001
71751184|NCT00988884|143005720|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|TWO_SIDED|97.5|-0.8|0.9|||Miettinen and Nurminen|||Anti-diphtheria titer \>=0.1 IU/mL||0.9|-0.8|<0.001
71751185|NCT00988884|143005720|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-0.2|||<|0.001|TWO_SIDED|97.5|-1.2|0.7|||Miettinen and Nurminen|||Anti-tetanus titer \>=0.1 IU/mL||0.7|-1.2|<0.001
71751186|NCT00988884|143005721|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.8||||0.003|TWO_SIDED|97.5|0.69|0.92|||ANOVA|||Anti-PT||0.92|0.69|0.003
71751187|NCT00988884|143005721|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.91|||<|0.001|TWO_SIDED|97.5|0.83|1.01|||ANOVA|||Anti-FHA||1.01|0.83|<0.001
71751188|NCT00988884|143005721|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.95|||<|0.001|TWO_SIDED|97.5|0.84|1.08|||ANOVA|||Anti-PRN||1.08|0.84|<0.001
71751189|NCT00988884|143005721|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is \>0.67|Fold difference in GMT|0.96|||<|0.001|TWO_SIDED|97.5|0.76|1.21|||ANOVA|||Anti-FIM 2/3||1.21|0.76|<0.001
71751190|NCT00988884|143005724|SUPERIORITY_OR_OTHER||Difference in percentage|-0.4||||0.806|TWO_SIDED|95.0|-3.5|2.7|||Miettinen and Nurminen|||||2.7|-3.5|0.806
71751191|NCT00549640|143005738|SUPERIORITY_OR_OTHER|||||||0.973||95.0|||||Fisher Exact|1-tailed||||||0.973
71668792|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.61|||||TWO_SIDED|95.0|-28.2|16.38|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine||16.38|-28.20|
71668793|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-3.59|||||TWO_SIDED|95.0|-27.55|15.98|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||15.98|-27.55|
71668794|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.98|||||TWO_SIDED|95.0|-23.52|23.99|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV season in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||23.99|-23.52|
71668795|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|-1.71|||||TWO_SIDED|95.0|-28.56|19.7|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory disease during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||19.70|-28.56|
71668796|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.8|||||TWO_SIDED|95.0|-22.14|26.0|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||26.00|-22.14|
71668797|NCT04886596|142853946|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|4.64|||||TWO_SIDED|95.0|-21.73|25.48|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of hospitalization due to any respiratory diseases or complication related to any respiratory diseases during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||25.48|-21.73|
71677096|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.6||||0.4954|TWO_SIDED|95.0|-3.11|6.38||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||6.38|-3.11|0.4954
71751192|NCT00549640|143005739|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|1 tailed test||||||0.500
71751193|NCT00549640|143005740|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline||||||0.65
71751194|NCT00549640|143005740|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|analysis performed using daily scores||||||0.79
71751195|NCT00660192|143005763|SUPERIORITY_OR_OTHER|||||||0.0347|TWO_SIDED||||||t-test, 2 sided|||||||0.0347
71751196|NCT00660192|143005764|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.0300
71835935|NCT03775109|143177236|SUPERIORITY||Odds Ratio (OR)|5.088|||||TWO_SIDED|95.0|1.558|16.624|||||Ordinal logistic regression (proportional odds) model. GAHS at day 28 = intercept + treatment group indicator + baseline GAHS measurement. 48 participants have GAHS data at baseline and day 28.|||16.624|1.558|
71835936|NCT03775109|143177237|SUPERIORITY|||||||0.343|||||||ANCOVA|ANCOVA model: mDF score at day 28 = intercept + treatment group indicator + baseline mDF score.||Natural log transformation used for both baseline and day 28 measurements. 49 participants have mDF measurements at baseline and day 28.||||0.343
71835937|NCT03775109|143177238|SUPERIORITY||Mean Difference (Net)|0.083|||||TWO_SIDED|95.0|-0.529|0.696|||||difference = canakinumab - placebo. natural log transformation used.|||0.696|-0.529|
71835938|NCT03775109|143177239|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71891682|NCT02148029|143304714|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.4||0.91|TWO_SIDED|95.0|-0.8|0.9|||t-test, 2 sided||Mean difference = PTS - No PTS|||0.9|-0.8|0.91
71835939|NCT03775109|143177240|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71891683|NCT03905928|143304715|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise general linear model conducted in FSL software using a one-sample t-test on the tobacco\>strawberry condition contrasts conducted at the subject-level.|A whole-brain, one-sample t-test was used with a voxel threshold p \<.001 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
71668798|NCT04886596|142853947|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.94|||||TWO_SIDED|95.0|28.91|82.15|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||82.15|28.91|
71677097|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.92|-6.24||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.24|-15.92|<0.0001
71751197|NCT02734693|143005765|SUPERIORITY||Mean Difference (Final Values)|-5.18|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-7.565|-2.802|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol.||-2.802|-7.565|<0.001
71751198|NCT02734693|143005768|SUPERIORITY||Mean Difference (Final Values)|23.67|STANDARD_ERROR_OF_MEAN|7.395||0.002|TWO_SIDED|95.0|8.987|38.346|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.346|8.987|0.002
71751199|NCT02734693|143005768|SUPERIORITY||Mean Difference (Net)|24.05|STANDARD_ERROR_OF_MEAN|7.389||0.002|TWO_SIDED|95.0|9.381|38.714|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol||38.714|9.381|0.002
71751200|NCT02898454|143005785|SUPERIORITY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.71|||ANCOVA|||Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.03|<0.0001
71751201|NCT02898454|143005786|SUPERIORITY||LS mean difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.51|||ANCOVA|||Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.51|-2.10|<0.0001
71758528|NCT02205736|143019221|SUPERIORITY|||||||0.0011||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0011
71835940|NCT03775109|143177241|SUPERIORITY||Cox Proportional Hazard|1.046|||||TWO_SIDED|95.0|0.147|7.424||||||||7.424|0.147|
71835941|NCT03775109|143177249|SUPERIORITY||Mean Difference (Net)|0.043|||||TWO_SIDED|95.0|-0.235|0.322|||||Difference = Canakinumab - Placebo|||0.322|-0.235|
71835942|NCT03775109|143177250|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.388|0.127|||||Difference = Canakinumab - Placebo|||0.127|-0.388|
71835943|NCT03775109|143177251|SUPERIORITY||Odds Ratio (OR)|4.012|||||TWO_SIDED|95.0|0.693|23.219||||||||23.219|0.693|
71835944|NCT03775109|143177252|SUPERIORITY||Odds Ratio (OR)|4.543|||||TWO_SIDED|95.0|0.543|38.043||||||||38.043|0.543|
71835945|NCT03775109|143177253|SUPERIORITY||Odds Ratio (OR)|1.745|||||TWO_SIDED|95.0|0.456|6.558||||||||6.558|0.456|
71835946|NCT03775109|143177254|SUPERIORITY||Odds Ratio (OR)|0.977|||||TWO_SIDED|95.0|0.281|3.397||||||||3.397|0.281|
71835947|NCT03775109|143177255|SUPERIORITY||Odds Ratio (OR)|0.768|||||TWO_SIDED|95.0|0.238|2.479||||||||2.479|0.238|
71835948|NCT05691452|143177269|SUPERIORITY||Mean Difference (Net)|20.05||||0.578|TWO_SIDED|95.0|-50.68|90.78||Generalized linear models generated estimated mean differences in the post-intervention values controlling for the baseline assessments.|Regression, Linear|||||90.78|-50.68|0.578
71835949|NCT05691452|143177270|SUPERIORITY||Mean Difference (Net)|-21.2||||0.61|TWO_SIDED|95.0|-101.9|59.5|||Regression, Linear|||||59.5|-101.9|0.61
71835950|NCT05691452|143177271|SUPERIORITY||Mean Difference (Net)|1.55||||0.674|TWO_SIDED|95.0|-5.68|8.78|||Regression, Linear|||||8.78|-5.68|0.674
71835951|NCT05691452|143177272|SUPERIORITY||Mean Difference (Net)|-21.6||||0.013|TWO_SIDED|95.0|-38.5|-4.59|||Regression, Linear|||||-4.59|-38.5|.013
71835952|NCT05691452|143177273|SUPERIORITY||Mean Difference (Net)|0.387||||0.29|TWO_SIDED|95.0|-0.335|1.109|||Regression, Linear|||||1.109|-0.335|0.29
71835953|NCT05691452|143177274|SUPERIORITY||Mean Difference (Net)|-0.203||||0.701|TWO_SIDED|95.0|-1.24|0.833|||Regression, Linear|||||0.833|-1.24|0.701
71835954|NCT05691452|143177275|SUPERIORITY||Mean Difference (Net)|-21.45||||0.376|TWO_SIDED|95.0|-68.99|26.08|||Regression, Linear|||||26.08|-68.99|0.376
71835955|NCT00739648|143177288|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7282|TWO_SIDED|90.0|0.86|1.39|||Regression, Linear|negative binomial regression model||||1.39|0.86|0.7282
71835956|NCT00739648|143177290|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.2||||0.9768|TWO_SIDED|90.0|-27.8|-2.66|||Mixed Models Analysis|||||-2.66|-27.8|0.9768
71835957|NCT00739648|143177291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.3||||0.9464|TWO_SIDED|90.0|-24.9|0.26|||Mixed Models Analysis|||||0.26|-24.9|0.9464
71835958|NCT04173663|143177292|SUPERIORITY||Slope|-3.27||||0.092|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the parental empowerment scale.||||||.092
71751202|NCT02898454|143005787|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.|LS mean difference|-5.13|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.46||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-4.46|-5.80|<0.0001
71751203|NCT02898454|143005788|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.44|||<|0.0001|TWO_SIDED|95.0|-2.87|-2.02||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.02|-2.87|<0.0001
71751204|NCT02898454|143005789|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.52|||<|0.0001|TWO_SIDED|95.0|8.98|12.07||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.07|8.98|<0.0001
71751205|NCT02898454|143005790|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.81||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.81|-1.15|<0.0001
71751206|NCT02898454|143005791|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-17.36|||<|0.0001|TWO_SIDED|95.0|-20.87|-13.85||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-13.85|-20.87|<0.0001
71751207|NCT02898454|143005792|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.59|-1.83||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.83|-2.59|<0.0001
71751208|NCT02898454|143005792|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.78|-2.03||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.03|-2.78|<0.0001
71751209|NCT02898454|143005793|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.92||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.92|-1.30|<0.0001
71783206|NCT03000439|143065291|OTHER||Difference in LS Mean|-4.19|||||TWO_SIDED|95.0|-15.78|7.4||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.40|-15.78|
71835959|NCT04173663|143177293|SUPERIORITY||Slope|-1.62||||1.54e-05|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.0000154
71835960|NCT04173663|143177294|SUPERIORITY||Slope|-0.19||||0.014|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.014
71835961|NCT04173663|143177295|SUPERIORITY||Slope|-0.13||||0.883|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||0.883
71835962|NCT04173663|143177296|SUPERIORITY||Slope|-0.11||||0.308|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (6 month post intervention)||||.308
71835963|NCT04173663|143177296|SUPERIORITY||Slope|-0.11||||0.355|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of services family applied for (12 month post intervention)||||.355
71835964|NCT04173663|143177297|SUPERIORITY||Slope|-0.06||||0.699|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services family is receiving (6 month post intervention)||||.699
71835965|NCT04173663|143177297|SUPERIORITY||Slope|-0.1||||0.573|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of government services the family is receiving (12 month post intervention)||||.573
71835966|NCT04173663|143177297|SUPERIORITY||Slope|-0.23||||0.43|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (6 month post intervention)||||.430
71751210|NCT02898454|143005793|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.8||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.80|-1.18|<0.0001
71751211|NCT02898454|143005794|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.36|||<|0.0001|TWO_SIDED|95.0|-25.45|-17.27||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.27|-25.45|<0.0001
71751212|NCT02898454|143005794|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-20.73|||<|0.0001|TWO_SIDED|95.0|-24.81|-16.65||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-16.65|-24.81|<0.0001
71751213|NCT01601535|143005837|OTHER|||||||0.14||||||MYCN Amplified vs. MYCN not Amplified|Fisher Exact|||||||0.14
71751214|NCT01601535|143005837|OTHER|||||||0.21|||||||Fisher Exact|MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative||||||0.21
71751215|NCT01601535|143005837|OTHER|||||||1|||||||Fisher Exact|Aurora A protein Positive vs. Aurora A protein Negative||||||1.0
71835967|NCT04173663|143177297|SUPERIORITY||Slope|0.27||||0.391|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of direct services the family is receiving (12 month post intervention)||||.391
71751216|NCT01601535|143005838|OTHER|||||||0.094||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.094
71751217|NCT01601535|143005838|OTHER|||||||0.63||||||UGT1A1 6\\6 vs. UGT1A1 6\\7 vs. UGT1A1 7\\7|Fisher Exact|||||||0.63
71835968|NCT04173663|143177298|SUPERIORITY||Slope|-0.44||||0.51|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (6 month post intervention)||||.510
71835969|NCT04173663|143177298|SUPERIORITY||Slope|0.64||||0.296|TWO_SIDED||||||Regression, Logistic|Logistic regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Whether participants were engaged or not engaged in vocational/educational activities (12 month post intervention)||||.296
71835970|NCT04173663|143177299|SUPERIORITY||Slope|-0.66||||0.361|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||||||.361
71835971|NCT04173663|143177300|SUPERIORITY||Slope|-0.08||||0.81|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (6 month post intervention)||||.810
71835972|NCT04173663|143177300|SUPERIORITY||Slope|-0.13||||0.678|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site, cohort, and baseline value of the measure.||Outcome Variable: Number of unmet service needs (12 month post intervention)||||.678
71891684|NCT03905928|143304716|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention that differ by the nicotine groups (18 mg/ml vs. 0 mg/ml) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
71891685|NCT03905928|143304717|SUPERIORITY|||||||||||||||||This was a whole-brain, voxel-wise repeated measures ANOVA conducted using FSL software on activation from baseline to post-intervention between the flavor groups (tobacco vs. strawberry) for the tobacco\>strawberry condition contrasts calculated at the subject-level. The means and standard deviations presented are the average post-pre scan difference scores of the BOLD percentage signal change of tobacco \> strawberry contrasts for each group.|A whole-brain, repeated measures ANOVA was used with a voxel threshold p \<.025 and cluster threshold p\<.05. This method results in unique p-values for each cluster identified.|||
71751218|NCT01601535|143005839|OTHER|||||||0.9||||||AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W|Fisher Exact|||||||0.90
71751219|NCT01601535|143005839|OTHER|||||||1||||||AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W|Fisher Exact|||||||1.0
71751220|NCT00647296|143005845|SUPERIORITY||Slope|-0.606|STANDARD_ERROR_OF_MEAN|0.408||0.1385|TWO_SIDED|95.0|-1.41|0.19|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.19|-1.41|0.1385
71751221|NCT00647296|143005845|SUPERIORITY||Slope|0.113|STANDARD_ERROR_OF_MEAN|0.39||0.7718|TWO_SIDED|95.0|-0.65|0.88|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||0.88|-0.65|0.7718
71835973|NCT04173663|143177301|SUPERIORITY||Slope|0.03||||0.924|TWO_SIDED||||||Regression, Linear|Linear regression controlled for study site and cohort,||||||.924
71835974|NCT01757665|143177302|SUPERIORITY||percent of patients|0.1|||||ONE_SIDED|95.0||0.7|||||Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.|The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.||0.7||
71835975|NCT02278562|143177337|SUPERIORITY|||||||0.37||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933. The Type I error probability associated with this test of this null hypothesis is 0.05.||||0.37
71835976|NCT02278562|143177337|SUPERIORITY|||||||0.955||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933.||||0.955
71835977|NCT02379156|143177340|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in core body temperature (Tcore) from baseline (BL) values to after cold exposure (Cold) were analyzed using a Mixed Model ANOVA. We hypothesized that participants with tetraplegia would have a greater decrease in Tcore when exposed to cool ambient temperature than control participants exposed to the same cool ambient temperature.||||<0.001
71835978|NCT02379156|143177340|SUPERIORITY|||||||0.006|||||||ANOVA|||Within-group differences in the change in (Tcore) in the participants with tetraplegia from BL values to Cold, with and without a dose of 10 mg of midodrine (two separate visits), were analyzed using a Repeated Measures ANOVA .||||0.006
71751222|NCT00647296|143005845|SUPERIORITY||Slope|0.401|STANDARD_ERROR_OF_MEAN|0.397||0.3146|TWO_SIDED|95.0|-0.38|1.18|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||1.18|-0.38|0.3146
71835979|NCT02379156|143177341|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||Between-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using an independent samples T-test. We hypothesized that participants with tetraplegia would have a greater percent change in total WAIS IV scores due to impaired cognitive function post cool ambient exposure.||||.042
71835980|NCT02379156|143177341|SUPERIORITY|||||||0.149|||||||t-test, 2 sided|||"Within-group differences in the percent change in total WAIS IV scores from BL to after cold ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in total WAIS IV scores than the same participants in the With drug condition."||||0.149
71835981|NCT02379156|143177342|SUPERIORITY||||||<|0.001|||||||ANOVA|||Between-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a mixed-model ANOVA for the AB vs Tetra comparison. We hypothesized that participants with tetraplegia would have a smaller change in Tsk due to being in a constant state of vasodilation.||||<0.001
71835982|NCT02379156|143177342|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within-group differences in the change in distal skin temperature temperature (Tsk) from baseline (BL) values to after ambient cold exposure (Cold) were analyzed using a repeated measures ANOVA for the within-group comparison of drug vs no drug in the tetraplegia group. We hypothesized that participants with tetraplegia with drug would have a larger decrease in Tsk due to enhanced peripheral vasoconstriction due to the drug's effects.||||<.001
71835983|NCT02379156|143177343|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Between-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using independent samples T-test. We hypothesized that participants with tetraplegia would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation.||||<0.001
71835984|NCT02379156|143177343|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||"Within-group differences in the percent change in microvascular perfusion from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a smaller percent change in microvascular perfusion due impaired vasomotor control which causes a constant state of vasodilation."||||0.066
71845353|NCT04649047|143204838|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-0.56||||-0.77|TWO_SIDED|95.0|-1.02|-0.1|||t-test, 2 sided|||||-0.10|-1.02|-0.77
71751223|NCT00647296|143005846|SUPERIORITY||Slope|0.395|STANDARD_ERROR_OF_MEAN|1.536||0.7973|TWO_SIDED|95.0|-2.61|3.4|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.40|-2.61|0.7973
71751224|NCT00647296|143005846|SUPERIORITY||Slope|2.009|STANDARD_ERROR_OF_MEAN|1.47||0.1732|TWO_SIDED|95.0|-0.87|4.89|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents better outcome.|||4.89|-0.87|0.1732
71751225|NCT00647296|143005846|SUPERIORITY||Slope|0.451|STANDARD_ERROR_OF_MEAN|1.497||0.7635|TWO_SIDED|95.0|-2.48|3.39|||Mixed Models Analysis||placebo minus active treatment arm, positive direction represents a better outcome.|||3.39|-2.48|0.7635
71751226|NCT00647296|143005857|SUPERIORITY||Slope|0.263|STANDARD_ERROR_OF_MEAN|0.19||0.1772|TWO_SIDED|95.0|-0.12|0.64|||Mixed Models Analysis||50 mg/day minus 150 mg/day arm, negative direction represents worse outcome.|||0.64|-0.12|0.1772
71668799|NCT04886596|142853947|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|63.8|||||TWO_SIDED|95.0|28.5|83.2|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||83.20|28.50|
71668800|NCT04886596|142853947|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|65.69|||||TWO_SIDED|95.0|28.56|85.47|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV- ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||85.47|28.56|
71668801|NCT04886596|142853947|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|62.87|||||TWO_SIDED|95.0|21.45|84.29|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to RSV-ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||84.29|21.45|
71668802|NCT04886596|142853948|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|2.59|||||TWO_SIDED|95.0|-8.29|12.42|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||12.42|-8.29|
71751227|NCT00647296|143005858|SUPERIORITY||Slope|-0.615|STANDARD_ERROR_OF_MEAN|0.73||0.4025|TWO_SIDED|95.0|-2.06|0.83|||Mixed Models Analysis||50 mg/day minus 300 mg/day treatment arm, negative direction represents worse outcome.|||0.83|-2.06|0.4025
71751228|NCT01787461|143005859|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.14||||0.358|TWO_SIDED|95.0|-0.16|0.44|||ANOVA|||Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.44|-0.16|0.358
71751229|NCT01787461|143005860|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.037||||0.568|TWO_SIDED|95.0|-0.19|0.27|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.||0.27|-0.19|0.568
71751230|NCT01787461|143005861|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.797|TWO_SIDED|95.0|-0.25|0.33|||ANOVA|||Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-0.25|0.797
71751231|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.965|TWO_SIDED|95.0|-0.29|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.29|0.965
71751232|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.674|TWO_SIDED|95.0|-0.2|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.20|0.674
71751233|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.916|TWO_SIDED|95.0|-0.35|0.32|||ANOVA|||Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.35|0.916
71751234|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.915|TWO_SIDED|95.0|-0.39|0.35|||ANOVA|||Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.35|-0.39|0.915
71835985|NCT02379156|143177344|SUPERIORITY|||||||0.127|||||||t-test, 2 sided|||Between-group differences in the percent change in VO2 from baseline to after cool ambient exposure were analyzed using independent samples t-test. We hypothesized that participants with tetraplegia would have a smaller percent change in VO2 consumption.||||0.127
71845354|NCT04649047|143204839|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.42||||-0.51|TWO_SIDED|95.0|-7.69|0.85|||t-test, 2 sided|||||0.85|-7.69|-0.51
71751235|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.672|TWO_SIDED|95.0|-0.4|0.26|||ANOVA|||Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.26|-0.40|0.672
71751236|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.655|TWO_SIDED|95.0|-0.27|0.43|||ANOVA|||Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.27|0.655
71751237|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.23|0.43|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.23|0.561
71751238|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.356|TWO_SIDED|95.0|-0.14|0.4|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.40|-0.14|0.356
71751239|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08||||0.669|TWO_SIDED|95.0|-0.28|0.43|||ANOVA|||Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.43|-0.28|0.669
71751240|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.954|TWO_SIDED|95.0|-0.32|0.34|||ANOVA|||Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.34|-0.32|0.954
71751241|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.684|TWO_SIDED|95.0|-0.34|0.22|||ANOVA|||Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.22|-0.34|0.684
71783207|NCT03000439|143065291|OTHER||Difference in LS Mean|2.31|||||TWO_SIDED|95.0|-37.06|41.68||||||CHQ01-Physical Functioning Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||41.68|-37.06|
71783208|NCT03000439|143065291|OTHER||Difference in LS Mean|-5.47|||||TWO_SIDED|95.0|-17.37|6.43||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.43|-17.37|
71783209|NCT03000439|143065291|OTHER||Difference in LS Mean|6.82|||||TWO_SIDED|95.0|-20.92|34.57||||||CHQ01-Social Limitations: Emotional Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||34.57|-20.92|
71783210|NCT03000439|143065291|OTHER||Difference in LS Mean|-6.22|||||TWO_SIDED|95.0|-18.95|6.5||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.50|-18.95|
71783211|NCT03000439|143065291|OTHER||Difference in LS Mean|11.09|||||TWO_SIDED|95.0|-46.24|68.42||||||CHQ01-Social Limitations: Physical Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||68.42|-46.24|
71783212|NCT03000439|143065291|OTHER||Difference in LS Mean|-1.45|||||TWO_SIDED|95.0|-13.97|11.06||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||11.06|-13.97|
71835986|NCT02379156|143177344|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||"Within-group differences in the percent change in VO2 consumption from baseline to after cool ambient exposure were analyzed using a paired samples t-test. We hypothesized that participants with tetraplegia in the No Drug condition would have a greater percent change in VO2 consumption due to impaired vasoconstriction and greater heat loss compared to the With Drug condition, in response to cool ambient exposure."||||0.964
71751242|NCT01787461|143005862|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.886|TWO_SIDED|95.0|-0.35|0.3|||ANOVA|||Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.30|-0.35|0.886
71751243|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.901|TWO_SIDED|95.0|-0.33|0.37|||ANOVA|||Change at Week 12, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.37|-0.33|0.901
71783213|NCT03000439|143065291|OTHER||Difference in LS Mean|17.2|||||TWO_SIDED|95.0|-28.01|62.41||||||CHQ01-Bodily Pain Subscale Standardized Score: DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||62.41|-28.01|
71783214|NCT03000439|143065291|OTHER||Difference in LS Mean|-5.15|||||TWO_SIDED|95.0|-13.24|2.93||||||CHQ01-Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||2.93|-13.24|
71783215|NCT03000439|143065291|OTHER||Difference in LS Mean|-15.03|||||TWO_SIDED|95.0|-33.12|3.06||||||CHQ01-Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||3.06|-33.12|
71783216|NCT03000439|143065291|OTHER||Difference in LS Mean|-5.32|||||TWO_SIDED|95.0|-16.92|6.29||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||6.29|-16.92|
71783217|NCT03000439|143065291|OTHER||Difference in LS Mean|-7.24|||||TWO_SIDED|95.0|-20.35|5.87||||||CHQ01-Global Behavior Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||5.87|-20.35|
71835987|NCT06311084|143177376|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71751244|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14||||0.399|TWO_SIDED|95.0|-0.19|0.47|||ANOVA|||Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.47|-0.19|0.399
71751245|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.875|TWO_SIDED|95.0|-0.38|0.32|||ANOVA|||Change at Week 12, Back of Hands-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.32|-0.38|0.875
71751246|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43||||0.005|TWO_SIDED|95.0|0.13|0.73|||ANOVA|||Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.73|0.13|0.005
71751247|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.876|TWO_SIDED|95.0|-0.33|0.38|||ANOVA|||Change at Week 24, Decolletage-Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.33|0.876
71751248|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.789|TWO_SIDED|95.0|-0.29|0.38|||ANOVA|||Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.29|0.789
71751249|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04||||0.901|TWO_SIDED|95.0|-0.31|0.38|||ANOVA|||Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.38|-0.31|0.901
71751250|NCT01787461|143005863|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.027|TWO_SIDED|95.0|0.04|0.72|||ANOVA|||Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.72|0.04|0.027
71751251|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.083||||0.688|TWO_SIDED|95.0|-0.1|0.27|||Cochran-Mantel-Haenszel|||Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.27|-0.10|0.688
71835988|NCT06311084|143177377|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71751252|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.121||||0.445|TWO_SIDED|95.0|-0.08|0.33|||Cochran-Mantel-Haenszel|||Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.33|-0.08|0.445
71751253|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.318|TWO_SIDED|95.0|0.01|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.01|0.318
71751254|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.012||||0.633|TWO_SIDED|95.0|-0.15|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.15|0.633
71751255|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.018||||0.996|TWO_SIDED|95.0|-0.23|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.23|0.996
71751256|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.059||||0.432|TWO_SIDED|95.0|-0.13|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.13|0.432
71751257|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.03||||0.833|TWO_SIDED|95.0|-0.13|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.19|-0.13|0.833
71751258|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.226||||0.171|TWO_SIDED|95.0|0.06|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.06|0.171
71751259|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.02||||0.796|TWO_SIDED|95.0|-0.16|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.16|0.796
71751260|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.033||||0.942|TWO_SIDED|95.0|-0.23|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.23|0.942
71751261|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.118||||0.405|TWO_SIDED|95.0|-0.05|0.28|||Cochran-Mantel-Haenszel|||Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.28|-0.05|0.405
71751262|NCT01787461|143005864|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.061||||0.687|TWO_SIDED|95.0|-0.14|0.26|||Cochran-Mantel-Haenszel|||Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.26|-0.14|0.687
71751263|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.384||||0.017|TWO_SIDED|95.0|0.23|0.54|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.54|0.23|0.017
71751264|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.248||||0.073|TWO_SIDED|95.0|0.09|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.40|0.09|0.073
71835989|NCT06311084|143177378|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835990|NCT06311084|143177379|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835991|NCT06311084|143177380|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835992|NCT06311084|143177381|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835993|NCT06311084|143177382|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835994|NCT06311084|143177383|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71751265|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.057||||0.117|TWO_SIDED|95.0|-0.11|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.11|0.117
71751266|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.096||||0.662|TWO_SIDED|95.0|-0.31|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.31|0.662
71751267|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.1||||0.373|TWO_SIDED|95.0|-0.05|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.25|-0.05|0.373
71751268|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.031||||0.294|TWO_SIDED|95.0|-0.19|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.12|-0.19|0.294
71751269|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.035||||0.857|TWO_SIDED|95.0|-0.2|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 12, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.20|0.857
71751270|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.206||||0.088|TWO_SIDED|95.0|0.02|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.39|0.02|0.088
71751271|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.193||||0.11|TWO_SIDED|95.0|-0.02|0.41|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.41|-0.02|0.110
71751272|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.205||||0.112|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.34|0.07|0.112
71751273|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.003||||0.614|TWO_SIDED|95.0|-0.13|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.13|0.614
71751274|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.011||||0.693|TWO_SIDED|95.0|-0.18|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.16|-0.18|0.693
71751275|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|0.079||||0.762|TWO_SIDED|95.0|-0.06|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.22|-0.06|0.762
71751276|NCT01787461|143005865|SUPERIORITY_OR_OTHER||Weighted Gamma Statistic|-0.013||||0.662|TWO_SIDED|95.0|-0.16|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Body - Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.||0.13|-0.16|0.662
71751277|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|3.93||||0.587|TWO_SIDED|95.0|-10.32|18.18|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||18.18|-10.32|0.587
71751278|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.08||||0.814|TWO_SIDED|95.0|-14.49|12.32|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||12.32|-14.49|0.814
71835995|NCT06311084|143177384|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835996|NCT06311084|143177385|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835997|NCT06311084|143177386|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835998|NCT06311084|143177387|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71835999|NCT06311084|143177388|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71668803|NCT04886596|142853948|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|6.7|||||TWO_SIDED|95.0|-4.05|16.39|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the study period in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||16.39|-4.05|
71751279|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.57||||0.453|TWO_SIDED|95.0|-16.14|8.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||8.99|-16.14|0.453
71668804|NCT04886596|142853948|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|10.95|||||TWO_SIDED|95.0|-0.68|21.31|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following a single dose of the RSVPreF3 OA investigational vaccine.||21.31|-0.68|
71668805|NCT04886596|142853948|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses.|VE|12.12|||||TWO_SIDED|95.0|0.32|22.58|||Poisson regression method||VE is defined as 1 minus the relative risk (RR). RR=the ratio of the incidence rates of RSVPreF3 Group over Placebo Group. VE (% ) = Vaccine Efficacy (Poisson method - adjusted by age, region and season).|To evaluate the vaccine efficacy of the RSVPreF3 OA investigational vaccine in the prevention of complications related to any ARI during the RSV seasons in adults ≥ 60 YOA, following annual revaccination of the RSVPreF3 OA investigational vaccine.||22.58|0.32|
71751280|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.16||||0.191|TWO_SIDED|95.0|-22.92|4.61|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.61|-22.92|0.191
71751281|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.685|TWO_SIDED|95.0|-10.07|15.28|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.28|-10.07|0.685
71751282|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|5.74||||0.48|TWO_SIDED|95.0|-11.67|23.15|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||23.15|-11.67|0.480
71751283|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.98||||0.299|TWO_SIDED|95.0|-17.29|5.34|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||5.34|-17.29|0.299
71668806|NCT04620746|142853984|SUPERIORITY|||||||0.98|||||||Chi-squared, Corrected|||||||0.98
71668807|NCT04620746|142853985|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71668808|NCT02777372|142854010|OTHER|||||||0.139|||||||Regression, Linear|||Effect of group on differences in ASR t scores from follicular to luteal.||||0.139
71751284|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.07||||0.107|TWO_SIDED|95.0|-20.04|1.9|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.90|-20.04|0.107
71783218|NCT03000439|143065291|OTHER||Difference in LS Mean|4.44|||||TWO_SIDED|95.0|-6.18|15.07||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.07|-6.18|
71668809|NCT02777372|142854011|OTHER|||||||0.843||||||Effect of group on ASR t score in the first luteal phase (no medication) to the second luteal phase (sertraline).|Regression, Linear|||||||0.843
71668810|NCT02777372|142854012|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71751285|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.82||||0.776|TWO_SIDED|95.0|-14.39|10.76|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||10.76|-14.39|0.776
71751286|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.33||||0.603|TWO_SIDED|95.0|-15.96|9.29|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||9.29|-15.96|0.603
71751287|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82||||0.51|TWO_SIDED|95.0|-15.23|7.6|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||7.60|-15.23|0.510
71783219|NCT03000439|143065291|OTHER||Difference in LS Mean|-7.46|||||TWO_SIDED|95.0|-24.37|9.45||||||CHQ01-Mental Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.45|-24.37|
71783220|NCT03000439|143065291|OTHER||Difference in LS Mean|-0.01|||||TWO_SIDED|95.0|-9.14|9.13||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||9.13|-9.14|
71845355|NCT04649047|143204840|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|0.85||||0.49|TWO_SIDED|95.0|-0.32|2.03|||t-test, 2 sided|||||2.03|-0.32|0.49
71668811|NCT04661150|142854014|SUPERIORITY||Treatment difference|23.8||||0.079|TWO_SIDED|90.0|1.3|44.7|||Chi-squared|||||44.7|1.3|0.079
71668812|NCT04661150|142854019|SUPERIORITY||Treatment difference|-4.8||||0.739|TWO_SIDED|90.0|-27.9|18.9|||Chi-squared|||||18.9|-27.9|0.739
71751288|NCT01787461|143005866|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.75||||0.225|TWO_SIDED|95.0|-17.7|4.2|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.20|-17.70|0.225
71751289|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.78||||0.214|TWO_SIDED|95.0|-0.46|2.02|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.02|-0.46|0.214
71751290|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.027|TWO_SIDED|95.0|0.12|2.09|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.09|0.12|0.027
71751291|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99||||0.049|TWO_SIDED|95.0|0.01|1.96|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.96|0.01|0.049
71751292|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17||||0.019|TWO_SIDED|95.0|0.2|2.14|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.14|0.20|0.019
71751293|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.449|TWO_SIDED|95.0|-0.36|0.8|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.36|0.449
71751294|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.105|TWO_SIDED|95.0|-0.07|0.8|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.80|-0.07|0.105
71751295|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.205|TWO_SIDED|95.0|-0.14|0.68|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.68|-0.14|0.205
71751296|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.1|TWO_SIDED|95.0|-0.06|0.77|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.77|-0.06|0.100
71751297|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.244|TWO_SIDED|95.0|-0.17|0.66|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.66|-0.17|0.244
71783221|NCT03000439|143065291|OTHER||Difference in LS Mean|-7.59|||||TWO_SIDED|95.0|-33.87|18.7||||||CHQ01-Self Esteem Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.70|-33.87|
71783222|NCT03000439|143065291|OTHER||Difference in LS Mean|4.98|||||TWO_SIDED|95.0|-4.81|14.77||||||CHQ01-General Health Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||14.77|-4.81|
71783223|NCT03000439|143065291|OTHER||Difference in LS Mean|-1.02|||||TWO_SIDED|95.0|-20.31|18.28||||||CHQ01-General Health Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||18.28|-20.31|
71668813|NCT04661150|142854020|SUPERIORITY||Treatment difference|4.8|||>|0.999|TWO_SIDED|90.0|-10.9|21.4|||Fisher Exact|||||21.4|-10.9|>0.999
71751298|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12||||0.594|TWO_SIDED|95.0|-0.32|0.56|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.56|-0.32|0.594
71751299|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.317|TWO_SIDED|95.0|-0.2|0.63|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.63|-0.20|0.317
71751300|NCT01787461|143005867|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.264|TWO_SIDED|95.0|-0.17|0.64|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.64|-0.17|0.264
71751301|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.16||||0.266|TWO_SIDED|95.0|-69.63|19.31|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||19.31|-69.63|0.266
71751302|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.79||||0.21|TWO_SIDED|95.0|-73.99|16.41|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||16.41|-73.99|0.210
71836000|NCT06311084|143177389|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71751303|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.78||||0.753|TWO_SIDED|95.0|-56.55|40.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.99|-56.55|0.753
71751304|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.9||||0.632|TWO_SIDED|95.0|-76.32|46.51|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||46.51|-76.32|0.632
71751305|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|4.54||||0.715|TWO_SIDED|95.0|-19.94|29.01|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.01|-19.94|0.715
71751306|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|6.35||||0.648|TWO_SIDED|95.0|-21.04|33.75|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||33.75|-21.04|0.648
71751307|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.49||||0.315|TWO_SIDED|95.0|-48.81|15.83|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||15.83|-48.81|0.315
71751308|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|14.42||||0.402|TWO_SIDED|95.0|-19.5|48.34|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||48.34|-19.50|0.402
71751309|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|12.43||||0.381|TWO_SIDED|95.0|-15.49|40.35|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||40.35|-15.49|0.381
71751310|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|1.49||||0.916|TWO_SIDED|95.0|-26.44|29.43|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||29.43|-26.44|0.916
71751311|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.88||||0.566|TWO_SIDED|95.0|-43.81|24.05|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||24.05|-43.81|0.566
71751312|NCT01787461|143005868|SUPERIORITY_OR_OTHER||LS Mean Difference|8.58||||0.667|TWO_SIDED|95.0|-30.78|47.94|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||47.94|-30.78|0.667
71751313|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.458|TWO_SIDED|95.0|-2.21|1.0|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.00|-2.21|0.458
71751314|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53||||0.497|TWO_SIDED|95.0|-2.07|1.01|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.01|-2.07|0.497
71751315|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.113|TWO_SIDED|95.0|-3.05|0.33|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.33|-3.05|0.113
71836001|NCT06311084|143177390|OTHER|We used Wilcoxon Signed-Rank Test for our non-normally distributed data to compare scores before and after the Imaginator intervention.||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71751316|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.708|TWO_SIDED|95.0|-2.11|1.44|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.44|-2.11|0.708
71751317|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24||||0.495|TWO_SIDED|95.0|-2.34|4.82|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||4.82|-2.34|0.495
71751318|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.85||||0.243|TWO_SIDED|95.0|-4.96|1.27|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||1.27|-4.96|0.243
71751319|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.36||||0.453|TWO_SIDED|95.0|-4.96|2.23|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.23|-4.96|0.453
71751320|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55||||0.745|TWO_SIDED|95.0|-2.79|3.89|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.89|-2.79|0.745
71751321|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.987|TWO_SIDED|95.0|-2.44|2.48|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.48|-2.44|0.987
71836002|NCT01351805|143177394|OTHER|Test of change from baseline as above.|Percent change in geometric means|8.19||||0.02|TWO_SIDED|95.0|1.52|15.31||IL-6 from baseline to one year: overall % change= 8.19% (95%CI 1.52-15.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||15.31|1.52|0.02
71836003|NCT01351805|143177394|OTHER|Test of change from baseline as above.|Percent change in geometric means|-0.73||||0.97|TWO_SIDED|95.0|-6.87|5.81||4\. IL-6 from baseline to one year: overall % change= -0.73% (95%CI -6.87 to 5.81).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||5.81|-6.87|0.97
71836004|NCT01351805|143177394|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1,p for interaction between strata.||||||0.12||||||Test of multiplicative interaction between the effects of the two supplements|p for interaction|||Test for interaction between effect of vitamin D and effect of omega-3 fatty acids on IL-6 change from baseline to 1 year||||0.12
71751322|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.42||||0.218|TWO_SIDED|95.0|-3.69|0.85|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||0.85|-3.69|0.218
71751323|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67||||0.63|TWO_SIDED|95.0|-3.41|2.08|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||2.08|-3.41|0.630
71751324|NCT01787461|143005869|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.576|TWO_SIDED|95.0|-2.06|3.68|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.||3.68|-2.06|0.576
71751325|NCT00383552|143005907|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71751326|NCT00383552|143005908|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71751327|NCT00383552|143005910|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71751328|NCT00383552|143005911|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71751329|NCT00383552|143005912|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Longitudinal Model|||||||0.073
71751330|NCT00383552|143005913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||BMI 25 to \<30|ANCOVA|||||||0.015
71751331|NCT00383552|143005913|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||BMI less than 25 and for BMI 30 or more|ANCOVA|||||||<0.001
71751332|NCT03096834|143005915|SUPERIORITY||Odds Ratio (OR)|2.73||||0.002|TWO_SIDED|95.0|1.43|5.19|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response (NRI).||||5.19|1.43|0.002
71751333|NCT03096834|143005916|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|0.55||0.004|TWO_SIDED|95.0|-2.67|-0.51|||Mixed Models Analysis|||Month 3||-0.51|-2.67|0.004
71751334|NCT03096834|143005917|SUPERIORITY||Mean Difference (Final Values)|-3.46|STANDARD_ERROR_OF_MEAN|1.13||0.003|TWO_SIDED|95.0|-5.7|-1.23|||Mixed Models Analysis|||Physical impairment domain||-1.23|-5.70|0.003
71751335|NCT03096834|143005917|SUPERIORITY||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-6.12|-1.7|||Mixed Models Analysis|||Everyday activities domain||-1.70|-6.12|<0.001
71783224|NCT03000439|143065291|OTHER||Difference in LS Mean|-0.03|||||TWO_SIDED|95.0|-0.4|0.33||||||CHQ01-Change in Health Subscale Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.33|-0.40|
71783225|NCT03000439|143065291|OTHER||Difference in LS Mean|0.48|||||TWO_SIDED|95.0|-0.68|1.65||||||CHQ01-Change in Health Subscale Score; DB Week48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.65|-0.68|
71783226|NCT03000439|143065291|OTHER||Difference in LS Mean|2.25|||||TWO_SIDED|95.0|-10.59|15.1||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||15.10|-10.59|
71783227|NCT03000439|143065291|OTHER||Difference in LS Mean|-25.07|||||TWO_SIDED|95.0|-60.96|10.82||||||CHQ01-Emotional Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||10.82|-60.96|
71751336|NCT03096834|143005918|SUPERIORITY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.43|-0.99|||Mixed Models Analysis|||||-0.99|-2.43|<0.001
71751337|NCT03096834|143005919|SUPERIORITY||Odds Ratio (OR)|3.16||||0.025|TWO_SIDED|95.0|1.11|9.01|||Cochran-Mantel-Haenszel|Adjusted for stratification factor (4-7 vs. 8-14) migraine days at Baseline after missing data are imputed as non-response||||9.01|1.11|0.025
71751338|NCT01405768|143005932|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
71751339|NCT01405768|143005934|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||.13
71751340|NCT03692208|143005936|OTHER|Quantitative outcomes from chart and survey data were summarized by basic descriptive statistics.|||||<|0.01||||||P-values were calculated. Only P values of \<0.05 were considered statistically significant.|Chi-squared|Chi-squared tests, Fisher's Exact tests, two-sample t-tests, and paired two-sample t-tests were utilized to assess the outcomes between study arms.||||||<0.01
71751341|NCT04233008|143005961|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71751342|NCT04233008|143005962|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
71751343|NCT04233008|143005963|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71751344|NCT04233008|143005964|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71751345|NCT04233008|143005965|SUPERIORITY||||||<|0.01|||||||Chi-squared|||||||<0.01
71751346|NCT04233008|143005967|SUPERIORITY|||||||0.8|||||||Chi-squared|||||||0.8
71751347|NCT00435409|143006019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2239||||0.9409|TWO_SIDED|95.0|0.9487|1.5789||Stratification factors included metastatic organ sites (2 or less versus \[vs\] more than \[\>\] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs \>1), from interactive voice response system (IVRS).|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.5789|0.9487|0.9409
71751348|NCT00435409|143006019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1084||||0.812|TWO_SIDED|95.0|0.8817|1.3935||Stratification factors include metastatic organ sites (2 or less versus \[vs\] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors||1.3935|0.8817|0.8120
71751349|NCT00435409|143006020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.3143|TWO_SIDED|95.0|0.69|1.97||A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.|Cochran-Mantel-Haenszel|||Independent radiology assessment||1.97|0.69|0.3143
71783228|NCT03000439|143065291|OTHER||Difference in LS Mean|1.87|||||TWO_SIDED|95.0|-13.55|17.29||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||17.29|-13.55|
71783229|NCT03000439|143065291|OTHER||Difference in LS Mean|-9.19|||||TWO_SIDED|95.0|-48.91|30.53||||||CHQ01-Time Impact on Parent Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||30.53|-48.91|
71751350|NCT00435409|143006020|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.1269|TWO_SIDED|95.0|0.83|2.13||A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.|Cochran-Mantel-Haenszel|||Investigator's assessment||2.13|0.83|0.1269
71751351|NCT00435409|143006022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0372||||0.6275|TWO_SIDED|95.0|0.8322|1.2927||Stratification factors (all from IVRS) included number of metastatic organ sites (\<=2 vs \>2 sites), hormone receptor status (HER2-/ER-/PR- vs all others), and prior chemotherapy regimens (1 vs \>1).|Log Rank||Hazard ratio for sunitinib + capecitabine versus capecitabine.|||1.2927|0.8322|0.6275
71751352|NCT00718510|143006070|OTHER||||||<|0.05||||||General Psychopathology Subscale Score|ANOVA|F(1,11)=5.03||Null hypothesis is that there was no difference in change of PANSS between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time). A sample size of 14 patients was needed to give 90% power to detect a 4 point difference on the PANSS. This included a drop-out rate of about 10%.||||<0.05
71751353|NCT00718510|143006071|OTHER|||||||0.46|||||||ANOVA|||Null hypothesis is that there was no difference in change of CGI ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.46
71751354|NCT00718510|143006072|OTHER|||||||0.55|||||||ANOVA|||Null hypothesis is that there was no difference in change of CDSS ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).||||0.55
71751355|NCT00883779|143006074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7|||Log Rank|||||0.70|0.46|<0.0001
71751356|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.39|0.64|||Log Rank|||PFS in adenocarcinoma subgroup||0.64|0.39|<0.0001
71751357|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||=|0.579|TWO_SIDED|95.0|0.6|1.33|||Log Rank|||PFS in non-adenocarcinoma subgroup||1.33|0.60|=0.579
71751358|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.28|0.53|||Log Rank|||PFS in never smoked subgroup||0.53|0.28|<0.0001
71751359|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||=|0.2067|TWO_SIDED|95.0|0.64|1.1|||Log Rank|||PFS in former/current smoker subgroup||1.10|0.64|=0.2067
71751360|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.12|0.35|||Log Rank|||PFS in subgroup EGFR mutation||0.35|0.12|<0.0001
71751361|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||=|0.7511|TWO_SIDED|95.0|0.67|1.34|||Log Rank|||PFS in subgroup EGFR wild-type||1.34|0.67|=0.7511
71751362|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||=|0.3169|TWO_SIDED|95.0|0.25|1.58|||Log Rank|||PFS in subgroup KRAS mutation||1.58|0.25|=0.3169
71751363|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.7|||Log Rank|||PFS in subgroup KRAS wild-type||0.70|0.37|<0.0001
71751364|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||=|0.0091|TWO_SIDED|95.0|0.31|0.86|||Log Rank|||PFS in subgroup EGFR IHC positive||0.86|0.31|=0.0091
71783230|NCT03000439|143065291|OTHER||Difference in LS Mean|-3.97|||||TWO_SIDED|95.0|-12.84|4.9||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||4.90|-12.84|
71783231|NCT03000439|143065291|OTHER||Difference in LS Mean|-9.3|||||TWO_SIDED|95.0|-32.35|13.75||||||CHQ01-Family Activities Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||13.75|-32.35|
71836005|NCT01351805|143177395|OTHER|Test of change from baseline as above.|Percent change in geometric means|7.12||||0.16|TWO_SIDED|95.0|-1.81|16.87||3\. HsCRP from baseline to one year: overall % change= 7.12% (95%CI -1.81-16.78).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||16.87|-1.81|0.16
71845356|NCT04649047|143204841|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-8.54||||-0.48|TWO_SIDED|95.0|-19.9|2.82|||t-test, 2 sided|||||2.82|-19.9|-0.48
71751365|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0179|TWO_SIDED|95.0|0.18|0.88|||Log Rank|||PFS in subgroup EGFR IHC negative||0.88|0.18|=0.0179
71751366|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||=|0.0017|TWO_SIDED|95.0|0.11|0.64|||Log Rank|||PFS in subgroup EGFR FISH positive||0.64|0.11|=0.0017
71751367|NCT00883779|143006076|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||=|0.188|TWO_SIDED|95.0|0.37|1.22|||Log Rank|||PFS in subgroup EGFR FISH negative||1.22|0.37|=0.1880
71751368|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||=|0.1213|TWO_SIDED|95.0|0.7|1.04|||Log Rank|||OS in overall participants (FAS population)||1.04|0.70|=0.1213
71751369|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.0356|TWO_SIDED|95.0|0.62|0.98|||Log Rank|||OS in subgroup adenocarcinoma||0.98|0.62|=0.0356
71751370|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||=|0.1157|TWO_SIDED|95.0|0.92|2.03|||Log Rank|||OS in subgroup non-adenocarcinoma||2.03|0.92|=0.1157
71751371|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||=|0.0056|TWO_SIDED|95.0|0.49|0.89|||Log Rank|||OS in subgroup never smoked||0.89|0.49|=0.0056
71751372|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||=|0.3473|TWO_SIDED|95.0|0.87|1.5|||Log Rank|||OS in subgroup current/former smoker||1.50|0.87|=0.3473
71751373|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||=|0.1614|TWO_SIDED|95.0|0.45|1.14|||Log Rank|||OS in subgroup EGFR mutation||1.14|0.45|=0.1614
71751374|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||=|0.1691|TWO_SIDED|95.0|0.55|1.11|||Log Rank|||OS in subgroup EGFR wild-type||1.11|0.55|=0.1691
71751375|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.1415|TWO_SIDED|95.0|0.19|1.28|||Log Rank|||OS in subgroup KRAS mutation||1.28|0.19|=0.1415
71751376|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||=|0.1447|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||OS in subgroup KRAS wild-type||1.08|0.59|=0.1447
71751377|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||=|0.031|TWO_SIDED|95.0|0.35|0.96|||Log Rank|||OS in EGFR IHC positive||0.96|0.35|=0.0310
71751378|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||=|0.0581|TWO_SIDED|95.0|0.21|1.05|||Log Rank|||OS in subgroup EGFR IHC negative||1.05|0.21|=0.0581
71783232|NCT03000439|143065291|OTHER||Difference in LS Mean|-3.52|||||TWO_SIDED|95.0|-14.84|7.81||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||7.81|-14.84|
71783233|NCT03000439|143065291|OTHER||Difference in LS Mean|-20.42|||||TWO_SIDED|95.0|-79.03|38.18||||||CHQ01-Family Cohesion Subscale Standardized Score; DB Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||38.18|-79.03|
71783234|NCT03000439|143065294|OTHER||Difference in LS Mean|-0.24|||||TWO_SIDED|95.0|-1.02|0.54||||||CHAQ-Discomfort Index at Week 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.54|-1.02|
71783235|NCT03000439|143065294|OTHER||Difference in LS Mean|0.54|||||TWO_SIDED|95.0|-0.49|1.57||||||CHAQ-Discomfort Index at Week 8: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.57|-0.49|
71783236|NCT03000439|143065294|OTHER||Difference in LS Mean|0.47|||||TWO_SIDED|95.0|-1.01|0.9||||||CHAQ-Discomfort Index at Week 12: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.90|-1.01|
71783237|NCT03000439|143065294|OTHER||Difference in LS Mean|0.55|||||TWO_SIDED|95.0|-0.49|1.58||||||CHAQ-Discomfort Index at Week 16: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.58|-0.49|
71783238|NCT03000439|143065294|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-0.98|1.45||||||CHAQ-Discomfort Index at Week 20: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.45|-0.98|
71751379|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||=|0.0063|TWO_SIDED|95.0|0.14|0.75|||Log Rank|||OS of subgroup EGFR FISH positive||0.75|0.14|=0.0063
71751380|NCT00883779|143006077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||=|0.3268|TWO_SIDED|95.0|0.4|1.36|||Log Rank|||OS of subgroup EGFR FISH negative||1.36|0.40|=0.3268
71751381|NCT00883779|143006079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81|||=|0.5289|TWO_SIDED|95.0|-6.2|11.8|||Chi-squared|||Difference in non-progression response rates||11.8|-6.2|=0.5289
71751382|NCT00883779|143006080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.14|||<|0.0001|TWO_SIDED|95.0|16.7|33.5|||Chi-squared|||Difference in objective response rates||33.5|16.7|<0.0001
71751383|NCT00883779|143006081|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.5|||Log Rank|||||0.50|0.21|<0.0001
71751384|NCT00883779|143006082|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.69|||Log Rank|||||0.69|0.45|<0.0001
71783239|NCT03000439|143065294|OTHER||Difference in LS Mean|0.32|||||TWO_SIDED|95.0|-0.51|1.14||||||CHAQ-Discomfort Index at Week 24: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.14|-0.51|
71783240|NCT03000439|143065294|OTHER||Difference in LS Mean|-0.42|||||TWO_SIDED|95.0|-1.87|1.03||||||CHAQ-Discomfort Index at Week 28: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.03|-1.87|
71783241|NCT03000439|143065294|OTHER||Difference in LS Mean|-0.33|||||TWO_SIDED|95.0|-1.53|0.88||||||CHAQ-Discomfort Index at Week 32: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.88|-1.53|
71783242|NCT03000439|143065294|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.36|0.74||||||CHAQ-Discomfort Index at Week 36: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.74|-1.36|
71783243|NCT03000439|143065294|OTHER||Difference in LS Mean|0.07|||||TWO_SIDED|95.0|-0.55|0.69||||||CHAQ-Discomfort Index at Week 40: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.55|
71751385|NCT00883779|143006084|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||=|0.0364|TWO_SIDED|95.0|0.63|0.99|||Log Rank|||||0.99|0.63|=0.0364
71751386|NCT00883779|143006086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||=|0.0181|TWO_SIDED|95.0|0.61|0.96|||Log Rank|||||0.96|0.61|=0.0181
71751387|NCT00883779|143006088|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.73|||=|0.0035|TWO_SIDED|95.0|0.59|0.9|||Log Rank|||||0.90|0.59|=0.0035
71751388|NCT00883779|143006089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.913|TWO_SIDED|95.0|0.6|1.59|||Log Rank|||||1.59|0.60|0.9130
71751389|NCT00659061|143006091|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||at baseline|Chi-squared|||||||0.32
71751390|NCT00659061|143006091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||at endline|Chi-squared|||||||<0.001
71751391|NCT00659061|143006093|SUPERIORITY_OR_OTHER||||||<|0||95.0|||||ANOVA|adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)||||||<0.000
71751392|NCT00659061|143006094|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||baseline|Chi-squared|||||||0.34
71751393|NCT00659061|143006094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||endline|Chi-squared|||||||<0.001
71751394|NCT00659061|143006095|SUPERIORITY_OR_OTHER|||||||0||95.0||||endline|ANOVA|adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement||||||0.000
71751395|NCT00659061|143006096|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||baseline|Chi-squared|||||||0.7
71751396|NCT00659061|143006096|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||endline|Chi-squared|||||||0.02
71891686|NCT03905928|143304718|SUPERIORITY|||||||0.573|||||||ANOVA|||We conducted a one-way ANOVA to compare the change in e-cigarette dependence (week 4 - week 2 PSECDI difference score) between the four e-cigarette groups.||||0.573
71891687|NCT03905928|143304720|SUPERIORITY|||||||0.022|||||||ANOVA|||We conducted a one-way ANOVA to compare changes in self-reported craving across all groups.||||.022
71891688|NCT02688647|143304764|SUPERIORITY|||||||0.5733|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 38.85 (95% CI: -126.99, 204.69) mL||||0.5733
71891689|NCT02688647|143304764|SUPERIORITY|||||||0.6967|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -39.96 (95% CI: -288.63, 208.71) mL||||0.6967
71891690|NCT02688647|143304764|SUPERIORITY|||||||0.5003|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 94.16 (95% CI: -1103.56, 1291.88) mL||||0.5003
71891691|NCT02688647|143304764|SUPERIORITY|||||||0.4866|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||No Prior Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = -34.13 (95% CI: -137.08, 68.82)||||0.4866
71891692|NCT02688647|143304767|SUPERIORITY|GAP Stage I-- Difference: Belumosudil-WC minus BSC-NC = 1.88 (95% CI: -2.69, 6.45)||||||0.3391|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.3391
71891693|NCT02688647|143304767|SUPERIORITY|GAP Stage II-- Difference: Belumosudil-WC minus BSC-NC = -1.72 (95% CI: -8.13, 4.69)||||||0.5201|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.5201
71783244|NCT03000439|143065294|OTHER||Difference in LS Mean|-0.31|||||TWO_SIDED|95.0|-1.01|0.39||||||CHAQ-Discomfort Index at Week 44: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.39|-1.01|
71783245|NCT03000439|143065294|OTHER||Difference in LS Mean|0.23|||||TWO_SIDED|95.0|-1.45|1.92||||||CHAQ-Discomfort Index at Week 48: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||1.92|-1.45|
71891694|NCT02688647|143304767|SUPERIORITY|GAP Stage III-- Difference: Belumosudil-WC minus BSC-NC = 2.48 (95% CI: -23.84, 28.81)||||||0.4426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4426
71891695|NCT02688647|143304767|SUPERIORITY|No Prior Use of Pirfenidone or Nintedanib-- Difference: Belumosudil-WC minus BSC-NC = 8.70 (95% CI: -78.76, -96.17)||||||0.426|||||||Mixed Models Analysis|Results are not stable due to small sample size and signal/noise ratio||||||0.4260
71891696|NCT02688647|143304777|SUPERIORITY|Cox Regression||||||0.8561|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.86 (0.16, 4.48)||||0.8561
71891697|NCT02688647|143304777|SUPERIORITY|Cox Regression||||||0.8608|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.87 (95% CI: 0.17, 4.33)||||0.8608
71668814|NCT03535740|142854022|OTHER|||||||0.0763||||||P-value was based on the comparison of the confirm ORR among the 90/180mg group against a fixed response rate of 20%.|Exact Binomial Test|The calculation was based on an exact binomial test with a total 1-sided alpha level of 0.025 at primary analysis.||||||0.0763
71668815|NCT05807828|142854040|SUPERIORITY||Median Difference (Final Values)|7.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the cup angle of the Control Group for Cup Training and the cup angle of VR Group for Cup Training.||||<0.05
71783246|NCT03000439|143065294|OTHER||Difference in LS Mean|-0.09|||||TWO_SIDED|95.0|-0.87|0.69||||||CHAQ-Discomfort Index at Week 52: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, Double-Blind baseline value, and Double-Blind baseline value by visit interaction.||0.69|-0.87|
71891698|NCT02688647|143304778|SUPERIORITY|Cox Regression||||||0.0084|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.14, 0.79)||||0.0084
71891699|NCT02688647|143304778|SUPERIORITY|Cox Regression||||||0.0508|TWO_SIDED|95.0|||||Log Rank|||Hazard Ratio: 0.47 (95% CI: 0.22, 1.03)||||0.0508
71891700|NCT02688647|143304780|SUPERIORITY|Cox Regression||||||0.4251|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.34 (95% CI: 0.02, 5.54)||||0.4251
71891701|NCT02688647|143304780|SUPERIORITY|Cox Regression||||||0.3294|TWO_SIDED|95.0|||||Log Rank|||Hazard ratio: 0.27 (95% CI: 0.02, 4.45)||||0.3294
71891702|NCT03619213|143304782|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0008|TWO_SIDED|95.0|0.73|0.92|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.92|0.73|0.0008
71891703|NCT03619213|143304783|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0085|TWO_SIDED|95.0|0.73|0.95|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||0.95|0.73|0.0085
71891704|NCT03619213|143304784|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0003|TWO_SIDED|95.0|0.67|0.89|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.89|0.67|0.0003
71891705|NCT03619213|143304785|SUPERIORITY||Rate Ratio (RR)|0.77||||0.0017|TWO_SIDED|95.0|0.65|0.9|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization||Comparison Group: Placebo||0.90|0.65|0.0017
71891706|NCT03619213|143304786|SUPERIORITY||Rate Ratio (RR)|1.11||||0.0086|TWO_SIDED|95.0|1.03|1.21||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score, stratified by T2DM status at randomisation.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in KCCQ Total Symptom Score at 8 months, or death before 8 months.|Comparison Group: Placebo||1.21|1.03|0.0086
71836006|NCT01351805|143177395|OTHER|Test of change from baseline as above.|Percent change in geometric means|-3.89||||0.44|TWO_SIDED|95.0|-11.92|4.86||6\. HsCRP from baseline to one year: overall % change= -3.89% (95%CI -11.92-4.86).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||4.86|-11.92|0.44
71836007|NCT01351805|143177395|SUPERIORITY|||||||0.38|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.38
71751397|NCT00659061|143006097|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||baseline|Chi-squared|||||||0.62
71751398|NCT00659061|143006097|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||endline|Chi-squared|||||||0.89
71751399|NCT00659061|143006098|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||baseline|Chi-squared|||||||0.93
71751400|NCT00659061|143006098|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||endline|Chi-squared|||||||0.49
71751401|NCT00079040|143006101|SUPERIORITY_OR_OTHER||Percentage|63.5|||||TWO_SIDED|90.0|52.4|73.6||||||||73.6|52.4|
71751402|NCT00467740|143006124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0754||95.0|-0.008|0.167|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.167|-0.008|0.0754
71751403|NCT00467740|143006124|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.045||0.0571||95.0|-0.003|0.174|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.174|-0.003|0.0571
71751404|NCT00467740|143006124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.045||0.0906||95.0|-0.012|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.164|-0.012|0.0906
71751405|NCT00467740|143006124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.044||0.0011||95.0|0.059|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.059|0.0011
71751406|NCT00467740|143006125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.238|STANDARD_ERROR_OF_MEAN|7.843||0.0393||95.0|0.801|31.675|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||31.675|0.801|0.0393
71751407|NCT00467740|143006125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.878|STANDARD_ERROR_OF_MEAN|7.875||0.0005||95.0|12.379|43.378|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||43.378|12.379|0.0005
71751408|NCT00467740|143006125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.072|STANDARD_ERROR_OF_MEAN|7.906|<|0.0001||95.0|20.512|51.633|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||51.633|20.512|<0.0001
71751409|NCT00467740|143006125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.943|STANDARD_ERROR_OF_MEAN|7.848|<|0.0001||95.0|27.498|58.389|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||58.389|27.498|<0.0001
71751410|NCT00467740|143006126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.044||0.1264||95.0|-0.019|0.154|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.154|-0.019|0.1264
71751411|NCT00467740|143006126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.044||0.0232||95.0|0.014|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.188|0.014|0.0232
71751412|NCT00467740|143006126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0106||95.0|0.027|0.2|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.027|0.0106
71751413|NCT00467740|143006126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.044||0.0001||95.0|0.087|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.260|0.087|0.0001
71751414|NCT00467740|143006127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.048||0.0329||95.0|0.008|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.198|0.008|0.0329
71751415|NCT00467740|143006127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.048||0.0666||95.0|-0.006|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.184|-0.006|0.0666
71751416|NCT00467740|143006127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.048||0.3738||95.0|-0.052|0.137|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.052|0.3738
71751417|NCT00467740|143006127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.048||0.0037||95.0|0.046|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.234|0.046|0.0037
71783247|NCT03000439|143065303|OTHER||Difference in percentage|-30.18|||||TWO_SIDED|95.0|-53.43|-6.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-6.94|-53.43|
71783248|NCT03000439|143065303|OTHER||Difference in percentage|-23.39|||||TWO_SIDED|95.0|-47.19|0.42|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||0.42|-47.19|
71751418|NCT00467740|143006128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.046||0.2646||95.0|-0.039|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.039|0.2646
71751419|NCT00467740|143006128|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.046||0.3527||95.0|-0.048|0.135|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.135|-0.048|0.3527
71783249|NCT03000439|143065303|OTHER||Difference in percentage|-0.12|||||TWO_SIDED|95.0|-23.99|23.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||23.76|-23.99|
71783250|NCT03000439|143065303|OTHER||Difference in percentage|6.68|||||TWO_SIDED|95.0|-17.2|30.56|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||30.56|-17.20|
71751420|NCT00467740|143006128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.046||0.1369||95.0|-0.022|0.16|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.160|-0.022|0.1369
71751421|NCT00467740|143006128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.046||0.0051||95.0|0.039|0.221|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.221|0.039|0.0051
71751422|NCT00467740|143006129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.053||0.017||95.0|0.023|0.232|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.232|0.023|0.0170
71751423|NCT00467740|143006129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.053||0.0646||95.0|-0.006|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.006|0.0646
71783251|NCT03000439|143065303|OTHER||Difference in percentage|13.13|||||TWO_SIDED|95.0|-9.92|36.19|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||36.19|-9.92|
71836008|NCT01351805|143177396|OTHER|Test of change from baseline as above.|Percent change in geometric means|0.63||||0.57|TWO_SIDED|95.0|-1.03|2.31||2\. TNFR2 from baseline to one year: overall % change= 0.63% (95%CI -1.03 to 2.31).|as above|p above adjusted for age, sex, race and n-3 fatty acid randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||2.31|-1.03|0.57
71836009|NCT01351805|143177396|OTHER|Test of change from baseline as above.|Percent change in geometric means|-1.27||||0.13|TWO_SIDED|95.0|-2.89|0.39||5\. TNFR2 from baseline to one year: overall % change= -1.27% (95%CI -2.89 to 0.39).|as above|p above adjusted for age, sex, race and vitamin D randomized treatment group.||Geometric means of biomarker concentrations with 95% CIs were calculated for baseline and 1 year biomarkers (IL-6, TNFR2 and CRP) by treatment group (active vs. placebo vitamin D). Linear repeated measures models calculated the % change in means for each biomarker from baseline to year one and the overall effects of randomized treatments with 95% CIs.||0.39|-2.89|0.13
71836010|NCT01351805|143177396|SUPERIORITY|Multiplicative interaction between strata based on linear models of ln biomarker from baseline to year 1 with p for interaction between strata.||||||0.74|||||||P for interaction|||Test for multiplicative interaction between effect of vitamin D and effect of omega-3. based on linear models of ln biomarker from baseline to year 1.||||0.74
71783252|NCT03000439|143065303|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||24.70|-24.24|
71783253|NCT03000439|143065303|OTHER||Difference in percentage|3.46|||||TWO_SIDED|95.0|-20.75|27.66|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||27.66|-20.75|
71783254|NCT03000439|143065303|OTHER||Difference in percentage|5.99|||||TWO_SIDED|95.0|-16.29|28.28|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||28.28|-16.29|
71751424|NCT00467740|143006129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.053||0.602||95.0|-0.077|0.132|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.132|-0.077|0.6020
71751425|NCT00467740|143006129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.053||0.0147||95.0|0.026|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.233|0.026|0.0147
71783255|NCT03000439|143065303|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
71783256|NCT03000439|143065303|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||34.39|-13.88|
71783257|NCT03000439|143065303|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||44.67|-3.43|
71751426|NCT00467740|143006130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.053||0.4902||95.0|-0.068|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.142|-0.068|0.4902
71751427|NCT00467740|143006130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.054||0.2832||95.0|-0.048|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.164|-0.048|0.2832
71751428|NCT00467740|143006130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.054||0.6516||95.0|-0.081|0.13|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.130|-0.081|0.6516
71751429|NCT00467740|143006130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.053||0.006||95.0|0.042|0.252|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.252|0.042|0.0060
71751430|NCT00467740|143006131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.05||0.0005||95.0|0.079|0.277|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.277|0.079|0.0005
71751431|NCT00467740|143006131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.051||0.007||95.0|0.038|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.038|0.0070
71751432|NCT00467740|143006131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.05||0.0512||95.0|-0.001|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.198|-0.001|0.0512
71751433|NCT00467740|143006131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.133|0.331|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.331|0.133|<0.0001
71751434|NCT00467740|143006132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.061||0.1811||95.0|-0.039|0.203|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.203|-0.039|0.1811
71783258|NCT03000439|143065303|OTHER||Difference in percentage|20.62|||||TWO_SIDED|95.0|-3.43|44.67|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||44.67|-3.43|
71783259|NCT03000439|143065303|OTHER||Difference in percentage|17.4|||||TWO_SIDED|95.0|-7.03|41.82|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||41.82|-7.03|
71751435|NCT00467740|143006132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.062||0.2118||95.0|-0.044|0.199|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.199|-0.044|0.2118
71751436|NCT00467740|143006132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.062||0.5504||95.0|-0.085|0.158|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.158|-0.085|0.5504
71751437|NCT00467740|143006132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.062||0.0022||95.0|0.069|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.312|0.069|0.0022
71751438|NCT00467740|143006133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.102|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.255|0.102|<0.0001
71751439|NCT00467740|143006133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.106|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.260|0.106|<0.0001
71751440|NCT00467740|143006133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.096|0.25|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.250|0.096|<0.0001
71751441|NCT00467740|143006133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.214|0.367|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.367|0.214|<0.0001
71751442|NCT00467740|143006134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.101|0.279|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.279|0.101|<0.0001
71783260|NCT03000439|143065304|OTHER||Difference in percentage|-26.61|||||TWO_SIDED|95.0|-50.42|-2.81|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||-2.81|-50.42|
71783261|NCT03000439|143065304|OTHER||Difference in percentage|-20.16|||||TWO_SIDED|95.0|-43.91|3.59|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||3.59|-43.91|
71836011|NCT01351805|143177397|OTHER||Cox Proportional Hazard|0.78||||0.05|TWO_SIDED|95.0|0.61|0.99|||Regression, Cox|||||0.99|0.61|0.05
71836012|NCT01351805|143177397|SUPERIORITY||Cox Proportional Hazard|0.85||||0.19|TWO_SIDED|95.0|0.67|1.08|||Regression, Cox|||||1.08|0.67|0.19
71836013|NCT01351805|143177397|SUPERIORITY|||||||0.2|||||||P for interaction|p multiplicative interaction between effects of vitamin D and n-3 fa supplements||Test for multiplicative interaction between the effects of randomized treatment groups, vitamin D and n-3 fa on incidence of autoimmune disease.||||0.20
71836014|NCT01351805|143177398|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to omega-3 fatty acids or omega-3 fatty acid placebo, regardless of vitamin D randomization status.||||||0.77||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Repeated measures model with censoring for total knee replacement.||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.||||0.77
71836015|NCT01351805|143177398|OTHER|We assessed the main effects of the treatment arms comparing all those randomized to vitamin D or vitamin D placebo, regardless of omega-3 fatty acid randomization status.||||||0.41||||||Repeated measures model with unstructured variance to assess effect of treatment on WOMAC Pain adjusting for age, sex, and other treatment. Linear time by treatment interaction term assessed change in WOMAC Pain over time in treatment vs placebo.|Mixed Models Analysis|Linear time by treatment interaction (comparing change in WOMAC pain over time in two randomized groups)||Intention to treat analysis using a repeated measures model with unstructured variance to assess the effect of treatment arm on WOMAC Pain adjusting for age, sex, and the other treatment arm. The linear time by treatment interaction term assessed change in WOMAC Pain over time between participants randomized to treatment versus placebo.|We assessed for effect modification between vitamin D and N-3 FA and tested for other pre-specified interactions. We again used a repeated measures model with censoring for TKR. We adjusted for age, sex and N-3 FA treatment arm (in analyses in which N-3 FA treatment arm was not investigated as a potential modifier).|||0.41
71836016|NCT01351805|143177398|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.42|TWO_SIDED||||||Regression, Linear|||Active n3fa vs placebo n3fa among those on placebo vitamin D.||||0.42
71845357|NCT04649047|143204842|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|64.46||||0.13|TWO_SIDED|95.0|-256.0|384.7|||t-test, 2 sided|||||384.7|-256|0.13
71751443|NCT00467740|143006134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001||95.0|0.107|0.286|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.286|0.107|<0.0001
71751444|NCT00467740|143006134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.045||0.0007||95.0|0.067|0.246|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.246|0.067|0.0007
71751445|NCT00467740|143006134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001||95.0|0.174|0.352|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.352|0.174|<0.0001
71751446|NCT00467740|143006135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.115|0.313|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.313|0.115|<0.0001
71751447|NCT00467740|143006135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.05||0.0021||95.0|0.057|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.255|0.057|0.0021
71751448|NCT00467740|143006135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.05||0.0795||95.0|-0.01|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.010|0.0795
71751449|NCT00467740|143006135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.326|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.326|0.129|<0.0001
71751450|NCT00467740|143006136|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.049||0.0003||95.0|0.082|0.276|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.276|0.082|0.0003
71783262|NCT03000439|143065304|OTHER||Difference in percentage|-9.79|||||TWO_SIDED|95.0|-34.31|14.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||14.72|-34.31|
71783263|NCT03000439|143065304|OTHER||Difference in percentage|0.23|||||TWO_SIDED|95.0|-24.24|24.7|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||24.70|-24.24|
71783264|NCT03000439|143065304|OTHER||Difference in percentage|10.25|||||TWO_SIDED|95.0|-13.88|34.39|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||34.39|-13.88|
71783265|NCT03000439|143065304|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||21.68|-27.67|
71751451|NCT00467740|143006136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.049||0.0077||95.0|0.035|0.229|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.229|0.035|0.0077
71783266|NCT03000439|143065304|OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-27.67|21.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||21.68|-27.67|
71783267|NCT03000439|143065304|OTHER||Difference in percentage|-6.91|||||TWO_SIDED|95.0|-30.65|16.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||16.83|-30.65|
71891707|NCT03619213|143304787|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1678|TWO_SIDED|95.0|0.74|1.05|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.05|0.74|0.1678
71751452|NCT00467740|143006136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.049||0.0427||95.0|0.003|0.197|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.003|0.0427
71751453|NCT00467740|143006136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.143|0.336|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.336|0.143|<0.0001
71783268|NCT03000439|143065304|OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-20.92|28.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||28.52|-20.92|
71783269|NCT03000439|143065304|OTHER||Difference in percentage|7.03|||||TWO_SIDED|95.0|-17.43|31.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||31.48|-17.43|
71783270|NCT03000439|143065304|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||42.52|-7.03|
71783271|NCT03000439|143065304|OTHER||Difference in percentage|14.52|||||TWO_SIDED|95.0|-10.52|39.55|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||39.55|-10.52|
71783272|NCT03000439|143065304|OTHER||Difference in percentage|17.74|||||TWO_SIDED|95.0|-7.03|42.52|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||42.52|-7.03|
71891708|NCT03619213|143304788|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3425|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||Comparison Group: Placebo||1.07|0.83|0.3425
71751454|NCT00467740|143006137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.048||0.0005||95.0|0.074|0.263|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.263|0.074|0.0005
71751455|NCT00467740|143006137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.048||0.0003||95.0|0.08|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.269|0.080|0.0003
71751456|NCT00467740|143006137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.268|0.078|0.0004
71751457|NCT00467740|143006137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.202|0.39|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.390|0.202|<0.0001
71751458|NCT00467740|143006138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.048||0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.268|0.078|0.0004
71751459|NCT00467740|143006138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.048||0.0002||95.0|0.09|0.281|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.281|0.090|0.0002
71751460|NCT00467740|143006138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.048||0.0047||95.0|0.043|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.043|0.0047
71751461|NCT00467740|143006138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001||95.0|0.142|0.332|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.332|0.142|<0.0001
71751462|NCT00467740|143006139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.055||0.0002||95.0|0.096|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.312|0.096|0.0002
71751463|NCT00467740|143006139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.055||0.0057||95.0|0.045|0.261|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.261|0.045|0.0057
71751464|NCT00467740|143006139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.055||0.1513||95.0|-0.029|0.186|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.186|-0.029|0.1513
71783273|NCT03000439|143065305|OTHER||Difference in percentage|-15.09|||||TWO_SIDED|95.0|-34.29|4.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.10|-34.29|
71783274|NCT03000439|143065305|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||4.65|-29.08|
71891709|NCT02073487|143304810|SUPERIORITY||||||<|0.01|||||||Fisher Exact|||||||<0.01
71891710|NCT00331760|143304838|SUPERIORITY|||||||0.12|||||||Chi-squared|||A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.||||0.12
71668816|NCT05807828|142854040|SUPERIORITY||Median Difference (Final Values)|291.5|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median difference between the stem angle of the Control Group for Stem Training and the stem angle of VR Group for Stem Training.||||<0.05
71668817|NCT05807828|142854041|SUPERIORITY||Mean Difference (Final Values)|54.5|STANDARD_DEVIATION|106.6|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student with VR training.||||<0.05
71668818|NCT05807828|142854041|SUPERIORITY||Mean Difference (Final Values)|89.8|STANDARD_DEVIATION|133.9|<|0.05|TWO_SIDED||||||paired t-test|||Each medical student carried out an implantation following VR training and without VR training. Therefore, there was a deviation (mean difference) between the predefined target and the implanted inclination for the cup or the stem version for the same medical student without VR training (control).||||<0.05
71668819|NCT05807828|142854042|SUPERIORITY||Median Difference (Final Values)|14.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for cup implantation for Control cup group and the time needed for cup implantation for VR cup group||||<0.05
71668820|NCT05807828|142854042|SUPERIORITY||Median Difference (Final Values)|2.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Median difference between the time needed for stem implantation for Control stem group and the time needed for stem implantation for VR stem group||||<0.05
71836017|NCT01351805|143177398|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Differences in WOMAC pain scores in stratified groups.|Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.8||0.18|TWO_SIDED||||||Regression, Linear|||Vitamin D vs. vitamin D placebo among those on placebo omega-3 fatty acids- stratified analyses.||||0.18
71836018|NCT01351805|143177398|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|1.89||0.84|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on active vitamin D.||||0.84
71668821|NCT02756611|142854062|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
71668822|NCT02756611|142854073|SUPERIORITY||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be \> 6%. If the p-value for this test was \< 0.025, the null hypothesis would be rejected.||||<0.001
71668823|NCT03135015|142854086|OTHER||Percentage Change from Control|-14.09||||0.1146|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.1146
71668824|NCT03135015|142854086|OTHER||Percentage Change from Control|-17.42||||0.0519|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.0519
71751465|NCT00467740|143006139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001||95.0|0.114|0.328|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.328|0.114|<0.0001
71751466|NCT00467740|143006140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.054||0.0022||95.0|0.06|0.271|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.271|0.060|0.0022
71751467|NCT00467740|143006140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.054||0.0307||95.0|0.011|0.223|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.223|0.011|0.0307
71783275|NCT03000439|143065305|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||7.10|-25.07|
71783276|NCT03000439|143065305|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||21.23|-12.01|
71783277|NCT03000439|143065305|OTHER||Difference in percentage|4.61|||||TWO_SIDED|95.0|-12.01|21.23|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||21.23|-12.01|
71783278|NCT03000439|143065305|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||7.10|-25.07|
71668825|NCT03135015|142854086|OTHER||Percentage Change from Control|-8.95|||||TWO_SIDED|||||||||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||
71783279|NCT03000439|143065305|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
71783280|NCT03000439|143065305|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
71836019|NCT01351805|143177398|OTHER|Linear regression - WOMAC pain over time mean (Standard error - SE). Report only in final year. Differences in WOMAC pain scores in cross-classified groups.|Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.8||0.76|TWO_SIDED||||||Regression, Linear|||Omega-3 fatty acids vs. omega-3 fatty acids placebo among those on placebo vitamin D.||||0.76
71668826|NCT03135015|142854087|OTHER|||||||0.1146|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.1146
71668827|NCT03135015|142854087|OTHER|||||||0.0519|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons||||0.0519
71836020|NCT03526861|143177405|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|13.8||||0.002|TWO_SIDED|95.0|5.3|22.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.3|5.3|0.002
71836021|NCT03526861|143177405|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|8.4|26.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with IGA score of 0 (clear) or 1 (almost clear) at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||26.6|8.4|<0.001
71751468|NCT00467740|143006140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.054||0.132||95.0|-0.025|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.187|-0.025|0.1320
71751469|NCT00467740|143006140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001||95.0|0.127|0.337|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.337|0.127|<0.0001
71751470|NCT00467740|143006141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.056||0.1585||95.0|-0.031|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.188|-0.031|0.1585
71751471|NCT00467740|143006141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0848||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.207|-0.013|0.0848
71751472|NCT00467740|143006141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.056||0.0838||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.207|-0.013|0.0838
71751473|NCT00467740|143006141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.056||0.0014||95.0|0.07|0.289|||Mixed Models Analysis||Olo 20 mcg qd minus Placebo|||0.289|0.070|0.0014
71751474|NCT00467740|143006142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.059||0.0959||95.0|-0.018|0.216|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.216|-0.018|0.0959
71751475|NCT00467740|143006142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.06||0.047||95.0|0.002|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.237|0.002|0.0470
71751476|NCT00467740|143006142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.06||0.196||95.0|-0.04|0.195|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.195|-0.040|0.1960
71751477|NCT00467740|143006142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.059||0.002||95.0|0.068|0.302|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.302|0.068|0.0020
71751478|NCT00467740|143006143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.064||0.027||95.0|0.016|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.269|0.016|0.0270
71751479|NCT00467740|143006143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.065||0.1031||95.0|-0.021|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.233|-0.021|0.1031
71751480|NCT00467740|143006143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.064||0.4378||95.0|-0.077|0.177|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.177|-0.077|0.4378
71783281|NCT03000439|143065305|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||11.87|-22.70|
71783282|NCT03000439|143065305|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
71783283|NCT03000439|143065305|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||16.48|-20.16|
71783284|NCT03000439|143065305|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||9.38|-26.66|
71783285|NCT03000439|143065305|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
71836022|NCT03526861|143177406|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.0|||<|0.001|TWO_SIDED|95.0|12.0|32.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.0|12.0|<0.001
71836023|NCT03526861|143177406|SUPERIORITY|Primary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|12.4|32.6||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects who achieved at least 75% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.6|12.4|<0.001
71836024|NCT03526861|143177407|SUPERIORITY|Secondary endpoint tested sequentially at a 2.5% significance level|Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|12.3|31.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.1|12.3|<0.001
71845358|NCT04649047|143204843|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.5||||0.88|TWO_SIDED|95.0|0.98|6.02|||t-test, 2 sided|||||6.02|0.98|0.88
71668828|NCT03135015|142854088|OTHER|||||||0.5827|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
71783286|NCT03000439|143065306|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||4.65|-29.08|
71783287|NCT03000439|143065306|OTHER||Difference in percentage|-14.75|||||TWO_SIDED|95.0|-35.32|5.83|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||5.83|-35.32|
71783288|NCT03000439|143065306|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||11.32|-27.91|
71783289|NCT03000439|143065306|OTHER||Difference in percentage|1.73|||||TWO_SIDED|95.0|-17.48|20.93|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||20.93|-17.48|
71783290|NCT03000439|143065306|OTHER||Difference in percentage|1.38|||||TWO_SIDED|95.0|-16.15|18.91|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||18.91|-16.15|
71783291|NCT03000439|143065306|OTHER||Difference in percentage|-5.41|||||TWO_SIDED|95.0|-22.7|11.87|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||11.87|-22.70|
71783292|NCT03000439|143065306|OTHER||Difference in percentage|-11.87|||||TWO_SIDED|95.0|-30.52|6.79|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||6.79|-30.52|
71783293|NCT03000439|143065306|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||13.94|-24.08|
71783294|NCT03000439|143065306|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||9.38|-26.66|
71783295|NCT03000439|143065306|OTHER||Difference in percentage|-11.52|||||TWO_SIDED|95.0|-31.65|8.61|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||8.61|-31.65|
71845359|NCT04649047|143204844|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.67||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
71845360|NCT04649047|143204845|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.5||||0.78|TWO_SIDED|95.0|0.82|8.18|||t-test, 2 sided|||||8.18|0.82|0.78
71668829|NCT03135015|142854088|OTHER|||||||0.5485|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
71668830|NCT03135015|142854089|OTHER||Percentage Change from Control|-8.53||||0.5827|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5827
71668831|NCT03135015|142854089|OTHER||Percentage Change from Control|9.32||||0.5485|TWO_SIDED||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment\*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.||||0.5485
71668832|NCT03135015|142854090|OTHER|||||||0.1234|||||||t-test, 2 sided|||||||0.1234
71668833|NCT03135015|142854090|OTHER|||||||0.0331|||||||t-test, 2 sided|||||||0.0331
71668834|NCT03135015|142854091|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.0500
71668835|NCT03135015|142854091|OTHER|||||||0.0568|||||||t-test, 2 sided|||||||0.0568
71668836|NCT03135015|142854092|OTHER|||||||0.0509|||||||t-test, 2 sided|||||||0.0509
71668837|NCT03135015|142854092|OTHER|||||||0.5016|||||||t-test, 2 sided|||||||0.5016
71668838|NCT03135015|142854093|OTHER|||||||0.8444|||||||t-test, 2 sided|||||||0.8444
71668839|NCT03135015|142854093|OTHER|||||||0.9681|||||||t-test, 2 sided|||||||0.9681
71668840|NCT03135015|142854093|OTHER|||||||0.1022|||||||t-test, 2 sided|||||||.1022
71668841|NCT03135015|142854093|OTHER|||||||0.3738|||||||t-test, 2 sided|||||||.3738
71668842|NCT03135015|142854093|OTHER||Mean Difference (Net)|-13.123|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED||||||||Percentage Change from Control|||||
71668843|NCT03135015|142854093|OTHER||Mean Difference (Net)|-10.362|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED||||||||Percentage Change from Control|||||
71668844|NCT03135015|142854093|OTHER||Mean Difference (Net)|-13.738|STANDARD_ERROR_OF_MEAN|13.463|||TWO_SIDED||||||||Percentage Change from Control|||||
71668845|NCT03135015|142854093|OTHER||Mean Difference (Net)|-12.929|STANDARD_ERROR_OF_MEAN|14.282|||TWO_SIDED||||||||Percentage Change from Control|||||
71668846|NCT03135015|142854094|OTHER|||||||0.0111|||||||t-test, 2 sided|||||||0.0111
71668847|NCT03135015|142854094|OTHER|||||||0.1684|||||||t-test, 2 sided|||||||0.1684
71668848|NCT03135015|142854094|OTHER||Mean Difference (Net)|-11.604|STANDARD_ERROR_OF_MEAN|6.722|||TWO_SIDED||||||||Percentage Change from Control|||||
71668849|NCT03135015|142854094|OTHER||Mean Difference (Net)|12.755|STANDARD_ERROR_OF_MEAN|8.489|||TWO_SIDED||||||||Percentage Change from Control|||||
71668850|NCT03135015|142854094|OTHER||Mean Difference (Net)|-13.293|STANDARD_ERROR_OF_MEAN|9.664|||TWO_SIDED||||||||Percentage Change from Control|||||
71668851|NCT03135015|142854094|OTHER||Mean Difference (Net)|2.526|STANDARD_ERROR_OF_MEAN|5.813|||TWO_SIDED||||||||Percentage Change from Control|||||
71668852|NCT03135015|142854095|OTHER||Percentage Change from Control|-21.09||||0.0374|TWO_SIDED||||||t-test, 2 sided|||||||0.0374
71668853|NCT03135015|142854096|OTHER||Percentage Change from Control|-24.22||||0.0098|TWO_SIDED||||||t-test, 2 sided|||||||0.0098
71668854|NCT03135015|142854096|OTHER||Percentage Change from Control|-25.02||||0.0391|TWO_SIDED||||||t-test, 2 sided|||||||0.0391
71783296|NCT03000439|143065306|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
71783297|NCT03000439|143065306|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||11.32|-27.91|
71783298|NCT03000439|143065306|OTHER||Difference in percentage|-5.07|||||TWO_SIDED|95.0|-24.08|13.94|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||13.94|-24.08|
71783299|NCT03000439|143065309|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 4||7.10|-25.07|
71783300|NCT03000439|143065309|OTHER||Difference in percentage|-19.01|||||TWO_SIDED|95.0|-35.25|-2.76|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 8||-2.76|-35.25|
71783301|NCT03000439|143065309|OTHER||Difference in percentage|-15.44|||||TWO_SIDED|95.0|-32.98|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 12||2.10|-32.98|
71783302|NCT03000439|143065309|OTHER||Difference in percentage|-12.56|||||TWO_SIDED|95.0|-27.22|2.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 16||2.10|-27.22|
71783303|NCT03000439|143065309|OTHER||Difference in percentage|-8.99|||||TWO_SIDED|95.0|-25.07|7.1|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 20||7.10|-25.07|
71783304|NCT03000439|143065309|OTHER||Difference in percentage|-12.21|||||TWO_SIDED|95.0|-29.08|4.65|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 24||4.65|-29.08|
71783305|NCT03000439|143065309|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 28||9.38|-26.66|
71783306|NCT03000439|143065309|OTHER||Difference in percentage|-8.64|||||TWO_SIDED|95.0|-26.66|9.38|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 32||9.38|-26.66|
71783307|NCT03000439|143065309|OTHER||Difference in percentage|-1.84|||||TWO_SIDED|95.0|-20.16|16.48|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 36||16.48|-20.16|
71783308|NCT03000439|143065309|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 40||15.72|-25.17|
71783309|NCT03000439|143065309|OTHER||Difference in percentage|-8.29|||||TWO_SIDED|95.0|-27.91|11.32|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 44||11.32|-27.91|
71783310|NCT03000439|143065309|OTHER||Difference in percentage|-4.72|||||TWO_SIDED|95.0|-25.17|15.72|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 48||15.72|-25.17|
71783311|NCT03000439|143065309|OTHER||Difference in percentage|2.07|||||TWO_SIDED|95.0|-18.53|22.68|||||The normal approximation to the difference in binomial proportions was used to generate 95% CI for the difference in percentage.|DB Week 52||22.68|-18.53|
71891711|NCT00331760|143304838|SUPERIORITY|||||||0.043|||||||Chi-squared|||A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.||||0.043
71891712|NCT02514044|143304846|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.008|||||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.008
71751481|NCT00467740|143006143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.064||0.0064||95.0|0.05|0.303|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.303|0.050|0.0064
71751482|NCT00467740|143006144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.069||0.2781||95.0|-0.061|0.21|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.210|-0.061|0.2781
71751483|NCT00467740|143006144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.069||0.3284||95.0|-0.068|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.204|-0.068|0.3284
71751484|NCT00467740|143006144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.069||0.602||95.0|-0.1|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.100|0.6020
71751485|NCT00467740|143006144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.069||0.0006||95.0|0.104|0.375|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.375|0.104|0.0006
71751486|NCT00467740|143006145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.067||0.4331|TWO_SIDED|95.0|-0.079|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.184|-0.079|0.4331
71751487|NCT00467740|143006145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.068||0.515|TWO_SIDED|95.0|-0.089|0.178|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||0.178|-0.089|0.5150
71751488|NCT00467740|143006145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.068||0.5714|TWO_SIDED|95.0|-0.095|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||0.171|-0.095|0.5714
71783312|NCT02370160|143065310|OTHER||||||||||||||||||In Phase I: There were 9 subjects treated on dose level 1 (60 µg/kg/dose). There were 6 subjects treated on Dose level 2 (80 µg/kg/dose). There were four DLT events happened in Phase I. One was treated on dose level 1 and the other three were treated on dose level 2. Therefore the MTD was dose level 1.|||
71783313|NCT04487730|143065324|SUPERIORITY||Mean Difference (Final Values)|0.4727||||0.6249|TWO_SIDED||||||Mixed Models Analysis|||Functional connectivity within the orbital prefrontal cortex (OFC; specifically between lateral and medial OFC), significantly changed over time.||||0.6249
71783314|NCT04487730|143065325|SUPERIORITY||Mean Difference (Final Values)|3.8176||||0.525|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.525
71783315|NCT04487730|143065326|SUPERIORITY||Mean Difference (Final Values)|0.6503||||0.844|TWO_SIDED||||||Mixed Models Analysis|||"Mixed effects model with a fixed effect for treatment and time, as well as time by treatment interaction, and a random effect for subject level.~F value for time by treatment interaction."||||.844
71783316|NCT01581931|143065327|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.69|STANDARD_DEVIATION|9.7|||TWO_SIDED|95.0|93.63|101.94|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||101.94|93.63|
71783317|NCT01581931|143065330|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.76|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|93.64|102.07|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||102.07|93.64|
71751489|NCT00467740|143006145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.068||0.0177|TWO_SIDED|95.0|0.028|0.296|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||0.296|0.028|0.0177
71836025|NCT03526861|143177407|SUPERIORITY|Secondary endpoint tested sequentially at a 5% significance level|Risk Difference (RD)|19.9|||<|0.001|TWO_SIDED|95.0|10.6|29.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Subjects with at least 4-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||29.2|10.6|<0.001
71836026|NCT03526861|143177408|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-19.7|||<|0.001|TWO_SIDED|95.0|-27.1|-12.2||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-12.2|-27.1|<0.001
71845361|NCT04649047|143204846|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.42||||0.58|TWO_SIDED|95.0|-0.32|7.16|||t-test, 2 sided|||||7.16|-0.32|0.58
71668855|NCT03135015|142854097|OTHER||Percentage Change from Control|-36.28||||0.0034|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0034
71751490|NCT00467740|143006146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|7.665||0.003|TWO_SIDED|95.0|7.883|38.057|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||38.057|7.883|0.0030
71751491|NCT00467740|143006146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.6|STANDARD_ERROR_OF_MEAN|7.7||0.0016|TWO_SIDED|95.0|9.446|39.754|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||39.754|9.446|0.0016
71751492|NCT00467740|143006146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.806|STANDARD_ERROR_OF_MEAN|7.727|<|0.0001|TWO_SIDED|95.0|21.598|52.015|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||52.015|21.598|<.0001
71751493|NCT00467740|143006146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.505|STANDARD_ERROR_OF_MEAN|7.675|<|0.0001|TWO_SIDED|95.0|27.399|57.611|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||57.611|27.399|<.0001
71751494|NCT00467740|143006147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118|STANDARD_ERROR_OF_MEAN|1.055||0.2898|TWO_SIDED|95.0|-3.194|0.957|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo|||0.957|-3.194|0.2898
71751495|NCT00467740|143006147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.351|STANDARD_ERROR_OF_MEAN|1.057||0.027|TWO_SIDED|95.0|-4.432|-0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo|||-0.269|-4.432|0.0270
71751496|NCT00467740|143006147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.045|STANDARD_ERROR_OF_MEAN|1.063||0.0045|TWO_SIDED|95.0|-5.138|-0.952|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo|||-0.952|-5.138|0.0045
71751497|NCT00467740|143006147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.937|STANDARD_ERROR_OF_MEAN|1.053||0.0056|TWO_SIDED|95.0|-5.01|-0.865|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo|||-0.865|-5.010|0.0056
71751498|NCT00467740|143006148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.257||0.2645|TWO_SIDED|95.0|-0.793|0.218|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.218|-0.793|0.2645
71751499|NCT00467740|143006148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.258||0.0423|TWO_SIDED|95.0|-1.034|-0.018|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.018|-1.034|0.0423
71751500|NCT00467740|143006148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.332|STANDARD_ERROR_OF_MEAN|0.259||0.2008|TWO_SIDED|95.0|-0.842|0.178|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.178|-0.842|0.2008
71751501|NCT00467740|143006148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.593|STANDARD_ERROR_OF_MEAN|0.257||0.0218|TWO_SIDED|95.0|-1.098|-0.087|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.087|-1.098|0.0218
71751502|NCT00467740|143006157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.142|STANDARD_ERROR_OF_MEAN|0.114||0.2156||95.0|-0.368|0.083|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.083|-0.368|0.2156
71845362|NCT04649047|143204847|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|2.42||||0.61|TWO_SIDED|95.0|-0.1|4.94|||t-test, 2 sided|||||4.94|-0.10|0.61
71845363|NCT04649047|143204848|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|3.83||||0.46|TWO_SIDED|95.0|-1.5|9.16|||t-test, 2 sided|||||9.16|-1.50|0.46
71751503|NCT00467740|143006157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.114||0.0869||95.0|-0.422|0.029|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.029|-0.422|0.0869
71836027|NCT03526861|143177408|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-18.0|||<|0.001|TWO_SIDED|95.0|-25.6|-10.4||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-10.4|-25.6|<0.001
71836028|NCT03526861|143177409|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 2.5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.6||||0.007|TWO_SIDED|95.0|-4.5|-0.7||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.7|-4.5|0.007
71751504|NCT00467740|143006157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.114||0.0044||95.0|-0.552|-0.103|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.103|-0.552|0.0044
71751505|NCT00467740|143006157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.113||0.0158||95.0|-0.499|-0.052|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo|||-0.052|-0.499|0.0158
71751506|NCT04999839|143006176|SUPERIORITY||Odds Ratio (OR)|3.727|||=|0.052|TWO_SIDED|95.0|0.933|14.885||P-value was calculated using a Cochran-Mantel-Haenszel (CMH) test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the Mantel-Haenszel (MH) method.|||14.885|0.933|=0.052
71751507|NCT04999839|143006176|SUPERIORITY||Odds Ratio (OR)|12.733|||<|0.001|TWO_SIDED|95.0|3.525|45.994||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||45.994|3.525|<0.001
71751508|NCT04999839|143006176|SUPERIORITY||Odds Ratio (OR)|29.014|||<|0.001|TWO_SIDED|95.0|8.526|98.735||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||98.735|8.526|<0.001
71751509|NCT04999839|143006176|SUPERIORITY||Odds Ratio (OR)|40.111|||<|0.001|TWO_SIDED|95.0|10.277|156.548||P-value was calculated using a CMH test, with prior treatment with biologics included as a stratification factor, comparing the percentage of participants in each dose of NDI-034858 vs placebo.|Cochran-Mantel-Haenszel||Odds ratio for achievement of PASI-75 was calculated using the MH method.|||156.548|10.277|<0.001
71751510|NCT02675907|143006201|SUPERIORITY|||||||0.0034|||||||t-test, 2 sided|||||||0.0034
71751511|NCT02675907|143006202|SUPERIORITY||||||<|0.05||||||Row 1 (SPID6)|t-test, 2 sided|||||||<0.05
71751512|NCT02675907|143006202|SUPERIORITY||||||<|0.01||||||Row 2 (SPID12)|t-test, 2 sided|||||||<0.01
71751513|NCT02675907|143006202|SUPERIORITY||||||<|0.01||||||Row 3 (SPID24)|t-test, 2 sided|||||||<0.01
71751514|NCT02675907|143006202|SUPERIORITY||||||<|0.01||||||Row 4 (SPID12-48)|t-test, 2 sided|||||||<0.01
71751515|NCT02675907|143006202|SUPERIORITY||||||<|0.01||||||Row 5 (SPID24-48)|t-test, 2 sided|||||||<0.01
71751516|NCT02675907|143006203|SUPERIORITY|||||||0.0076|||||||Log Rank|||||||0.0076
71751517|NCT02675907|143006204|SUPERIORITY||||||<|0.001||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel|||||||<0.001
71896211|NCT01709799|143314374|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,90.577)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||< .001
71751518|NCT02675907|143006204|SUPERIORITY||||||<|0.01||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel|||||||<0.01
71751519|NCT02675907|143006204|SUPERIORITY||||||<|0.01||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel|||||||<0.01
71751520|NCT02675907|143006205|SUPERIORITY||||||<|0.05||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
71751521|NCT02675907|143006205|SUPERIORITY||||||<|0.05||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
71751522|NCT02675907|143006205|SUPERIORITY||||||<|0.05||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site||||||<0.05
71751523|NCT02675907|143006206|SUPERIORITY|||||||0.1228|||||||Log Rank|||||||0.1228
71751524|NCT02675907|143006207|SUPERIORITY|||||||0.1048|||||||Log Rank|||||||0.1048
71751525|NCT02675907|143006208|SUPERIORITY|||||||0.0451|||||||Cochran-Mantel-Haenszel|||||||0.0451
71751526|NCT02675907|143006209|SUPERIORITY|||||||0.0107|||||||Cochran-Mantel-Haenszel|||||||0.0107
71751527|NCT02675907|143006210|SUPERIORITY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||||||0.0781
71751528|NCT02675907|143006211|SUPERIORITY|||||||0.043|||||||Cochran-Mantel-Haenszel|||||||0.0430
71751529|NCT02675907|143006212|SUPERIORITY|||||||0.107|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.1070
71751530|NCT02675907|143006213|SUPERIORITY|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site||||||0.0046
71751531|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|1.07||||0.009|TWO_SIDED|95.0|0.85|1.36||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot B||1.36|0.85|0.009
71751532|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.91||||0.009|TWO_SIDED|0.91|0.71|1.15||Threshold for significance of p value was 0.05.|ANOVA|||A/Solomon Islands (H1N1): FluBlok: Lot A versus FluBlok: Lot C||1.15|0.71|0.009
71751533|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.009|TWO_SIDED|95.0|0.67|1.07|||ANOVA|Threshold for significance of p value was 0.05.||A/Solomon Islands (H1N1): FluBlok: Lot B versus FluBlok: Lot C||1.07|0.67|0.009
71751534|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|2.03||||0.065|TWO_SIDED|95.0|1.56|2.64||Threshold of significance for p value was 0.05.|ANOVA|||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot B||2.64|1.56|0.065
71751535|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|1.63||||0.065|TWO_SIDED|95.0|1.26|2.11|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot A versus FluBlok: Lot C||2.11|1.26|0.065
71751536|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.8||||0.065|TWO_SIDED|95.0|0.62|1.04|||ANOVA|Threshold of significance for p value was 0.05.||A/Wisconsin (H3N2): FluBlok: Lot B versus FluBlok: Lot C||1.04|0.62|0.065
71751537|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. B falls within 0.67 to 1.5.|GMT ratio|0.88||||0.011|TWO_SIDED|95.0|0.69|1.13|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot B||1.13|0.69|0.011
71751538|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot A vs. C falls within 0.67 to 1.5.|GMT ratio|0.85||||0.011|TWO_SIDED|95.0|0.65|1.09|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot A versus FluBlok: Lot C||1.09|0.65|0.011
71751539|NCT00539981|143006217|EQUIVALENCE|Equivalence between 2 lots for each strain was concluded if the 2-sided 95% CI for the ratio of post-vaccination GMTs for Lot B vs. C falls within 0.67 to 1.5.|GMT ratio|0.96||||0.011|TWO_SIDED|95.0|0.75|1.23|||ANOVA|Threshold of significance for p value was 0.05.||B/Malaysia: FluBlok: Lot B versus FluBlok: Lot C||1.23|0.75|0.011
71751540|NCT00539981|143006218|SUPERIORITY|Relative protective efficacy is equivalent to absolute efficacy which is defined as the reduction in the influenza rate for Flublok relative to placebo.|Relative protective efficacy|75.4|||||TWO_SIDED|95.0|-148.0|99.5||||||FluBlok versus Placebo||99.5|-148.0|
71783318|NCT01581931|143065331|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|98.79|STANDARD_DEVIATION|10.0|||TWO_SIDED|90.0|94.55|103.21|||ANOVA||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.|||103.21|94.55|
71751541|NCT01611792|143006221|SUPERIORITY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|9.02|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
71751542|NCT01611792|143006222|SUPERIORITY||Mean Difference (Net)|-6.67|STANDARD_DEVIATION|11.86||0.0038|TWO_SIDED||||||Mixed Models Analysis|||||||0.0038
71751543|NCT01611792|143006223|SUPERIORITY||Mean Difference (Net)|2.0|STANDARD_DEVIATION|5.36||0.36|TWO_SIDED||||||Mixed Models Analysis|||||||0.36
71751544|NCT01611792|143006224|SUPERIORITY||Mean Difference (Net)|-1.31|STANDARD_DEVIATION|1.98||0.0018|TWO_SIDED||||||Mixed Models Analysis|||||||0.0018
71751545|NCT01611792|143006225|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
71751546|NCT01611792|143006226|SUPERIORITY||Mean Difference (Net)|0.69|STANDARD_DEVIATION|2.12||0.19|TWO_SIDED||||||Mixed Models Analysis|||||||0.19
71751547|NCT00395746|143006286|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.27|||<|0.0001||95.0|-1.51|1.02||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||1.02|-1.51|<0.0001
71751548|NCT00395746|143006286|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.0|||<|0.0001||95.0|-1.24|-0.75|||ANOVA|A significance level of a two-sided 5% was used for statistical hypothesis testing.||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."||-0.75|-1.24|<0.0001
71783319|NCT00964860|143065338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05||0.001|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%. Units on the MGI Scale.|||||0.001
71845364|NCT04649047|143204849|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|4.08||||0.71|TWO_SIDED|95.0|0.43|7.73|||t-test, 2 sided|||||7.73|0.43|0.71
71751549|NCT00395746|143006287|SUPERIORITY_OR_OTHER||Least Squares Mean|-1.33||||||95.0|-1.62|-1.04|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.04|-1.62|
71783320|NCT00964860|143065339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.004|ONE_SIDED|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%|||||0.004
71783321|NCT03716024|143065340|SUPERIORITY||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|1.3|26.0|||||omadacycline minus linezolid|||26.0|1.3|
71783322|NCT03716024|143065341|SUPERIORITY||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-1.7|11.4|||||omadacycline minus linezolid|||11.4|-1.7|
71783323|NCT03716024|143065342|SUPERIORITY||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|0.9|26.7|||||omadacycline minus linezolid|||26.7|0.9|
71783324|NCT03716024|143065343|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-5.3|14.0||||||||14.0|-5.3|
71783325|NCT00044083|143065402|OTHER||||||<|0.0001||||||Diagnosis effect on placebo|ANOVA|||||||<0.0001
71751550|NCT00395746|143006287|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.96||||||95.0|-1.25|-0.67|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-0.67|-1.25|
71751551|NCT00395746|143006288|SUPERIORITY_OR_OTHER||Least Squares Mean|-32.4|||<|0.0001||95.0|-40.5|-24.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-24.2|-40.5|<0.0001
71751552|NCT00395746|143006288|SUPERIORITY_OR_OTHER||Least Squares Mean|-26.4|||<|0.0001||95.0|-34.5|-18.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.||-18.2|-34.5|<0.0001
71751553|NCT00395746|143006289|SUPERIORITY_OR_OTHER||Least Squares Mean|-30.2||||||95.0|-39.6|-20.7|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-20.7|-39.6|
71751554|NCT00395746|143006289|SUPERIORITY_OR_OTHER||Least Squares Mean|-24.4||||||95.0|-33.8|-14.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-14.9|-33.8|
71783326|NCT00044083|143065402|OTHER|||||||0.0034||||||Drug Effect on Patients|ANOVA|||||||0.0034
71783327|NCT00044083|143065403|OTHER||||||<|0.0001||||||Diagnosis Effect on Placebo in right DLPFC|ANOVA|||||||<0.0001
71783328|NCT00044083|143065403|OTHER|||||||0.014||||||Diagnosis Effect of Placebo in left DLPFC|ANOVA|||||||0.014
71783329|NCT00044083|143065404|OTHER|||||||0.05||||||Drug Effect across both groups in left DLPFC|ANOVA|||||||0.05
71783330|NCT00044083|143065404|OTHER|||||||0.32||||||Drug Effect across both groups in right DLPFC|ANOVA|||||||0.32
71783331|NCT00044083|143065405|OTHER|||||||0.05||||||The Effect of Drug on Patients with Schizophrenia in right DLPFC|t-test, 1 sided|||||||0.05
71783332|NCT00044083|143065405|OTHER|||||||0.078||||||Effect of Drug on Patients with Schizophrenia in left DLPFC|t-test, 1 sided|||||||0.078
71783333|NCT00044083|143065406|OTHER|||||||0.05||||||Drug Effect on Healthy Volunteers in left DLPFC|t-test, 1 sided|||||||0.05
71783334|NCT00044083|143065406|OTHER|||||||0.73||||||Drug Effect on Healthy Volunteers in right DLPFC|t-test, 1 sided|||||||0.73
71783335|NCT00044083|143065407|OTHER||||||<|0.0001|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in right DLPFC||||||<0.0001
71783336|NCT00044083|143065407|OTHER|||||||0.167|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in left DLPFC||||||0.167
71783337|NCT00044083|143065408|OTHER|||||||0.189||||||Drug by Genotype Effect in left DLPFC|ANOVA|||||||0.189
71783338|NCT00044083|143065408|OTHER|||||||0.041||||||Drug Effect on Val/Val Genotype in left DLPFC|t-test, 1 sided|||||||0.041
71783339|NCT00044083|143065408|OTHER|||||||0.718||||||Drug Effect on Val/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.718
71783340|NCT00044083|143065408|OTHER|||||||0.469||||||Drug Effect of Met/Met Genotype in left DLPFC|t-test, 1 sided|||||||0.469
71783341|NCT00044083|143065409|OTHER|||||||0.7||||||Drug Effect on Positive Syndrome for Patients|t-test, 1 sided|||||||0.7
71783342|NCT00044083|143065409|OTHER|||||||0.4||||||Drug Effect on Negative Syndrome for Patients|t-test, 1 sided|||||||0.4
71783343|NCT00044083|143065409|OTHER|||||||0.12||||||Drug Effect on General Pathology for Patients|t-test, 1 sided|||||||0.12
71783344|NCT03066804|143065418|SUPERIORITY||Geometric Mean Ratio|0.8362|||<|0.0001|TWO_SIDED|95.0|0.7987|0.8754|||Mixed Models Analysis|||Week 12||0.8754|0.7987|<0.0001
71783345|NCT03066804|143065419|SUPERIORITY||Mean Difference (Net)|-2.4985||||0.4164|TWO_SIDED|95.0|-8.5267|3.52297|||Mixed Models Analysis|||||3.52297|-8.5267|0.4164
71783346|NCT03066804|143065420|SUPERIORITY||Mean Difference (Net)|0.5231||||0.4791|TWO_SIDED|95.0|-0.9258|1.972|||Mixed Models Analysis|||||1.9720|-0.9258|0.4791
71783347|NCT03066804|143065421|SUPERIORITY||Odds Ratio (OR)|0.8993||||0.5294|TWO_SIDED|95.0|0.6461|1.2518|||longitudinal binary logistic regression|||||1.2518|0.6461|0.5294
71783348|NCT03066804|143065422|SUPERIORITY||Odds Ratio (OR)|1.106||||0.4938|TWO_SIDED|95.0|0.8287|1.476|||longitudinal binary logistic regression|||||1.4760|0.8287|0.4938
71783349|NCT03066804|143065423|SUPERIORITY||Odds Ratio (OR)|0.9798||||0.8314|TWO_SIDED|95.0|0.8122|1.182|||Proportional cumulative odds model|||||1.1820|0.8122|0.8314
71783350|NCT03066804|143065424|SUPERIORITY||Mean Difference (Net)|-0.157||||0.637||95.0|-0.8093|0.4953|||Mixed Models Analysis|||||0.4953|-0.8093|0.6370
71783351|NCT02899793|143065425|SUPERIORITY|||||||0.024|||||||Fisher Exact|||Subgroup difference in ORRs||||0.024
71783352|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-65.5||||0.0275|TWO_SIDED|95.0|-78.0|-58.0|||2-sided Wilcoxon Rank Sum|||||-58.00|-78.00|0.0275
71668856|NCT03135015|142854097|OTHER||Percentage Change from Control|-33.21||||0.0058|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0058
71668857|NCT03135015|142854097|OTHER||Percentage Change from Control|-53.27||||0.0016|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0016
71668858|NCT03135015|142854097|OTHER||Percentage Change from Control|-46.19||||0.0125|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0125
71668859|NCT03135015|142854098|OTHER||Percentage Change from Control|-31.36||||0.0788|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0788
71783353|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-61.0||||0.025|TWO_SIDED|95.0|-65.0|-44.0|||2-sided Wilcoxon Rank Sum|||||-44.00|-65.00|0.025
71783354|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-32.5||||0.0136|TWO_SIDED|95.0|-47.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-47.00|0.0136
71783355|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-36.5||||0.0136|TWO_SIDED|95.0|-62.0|-9.0|||2-sided Wilcoxon Rank Sum|||||-9.00|-62.00|0.0136
71783356|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-59.0||||0.025|TWO_SIDED|95.0|-70.0|-38.0|||2-sided Wilcoxon Rank Sum|||||-38.00|-70.00|0.025
71783357|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-66.0||||0.0119|TWO_SIDED|95.0|-68.0|-61.0|||2-sided Wilcoxon Rank Sum|||||-61.00|-68.00|0.0119
71783358|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-15.5||||0.2667|TWO_SIDED|95.0|-38.0|17.0|||2-sided Wilcoxon Rank Sum|||||17.00|-38.00|0.2667
71783359|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-68.0||||0.0238|TWO_SIDED|95.0|-74.0|-59.0|||2-sided Wilcoxon Rank Sum|||||-59.00|-74.00|0.0238
71845365|NCT04649047|143204850|NON_INFERIORITY|Paired T test (pre- post-)|Mean Difference (Final Values)|-3.67||||-0.52|TWO_SIDED|95.0|-8.12|0.79|||t-test, 2 sided|||||0.79|-8.12|-0.52
71783360|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-56.5||||0.0007|TWO_SIDED|95.0|-65.0|-39.0|||2-sided Wilcoxon Rank Sum|||||-39.00|-65.00|0.0007
71783361|NCT03310021|143065429|SUPERIORITY||Hodges lehman Location shift|-35.0||||0.0121|TWO_SIDED|95.0|-53.0|-24.0|||2-sided Wilcoxon Rank Sum|||||-24.00|-53.00|0.0121
71783362|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-80.0||||0.0256|TWO_SIDED|95.0|-83.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-83.00|0.0256
71783363|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-79.5||||0.025|TWO_SIDED|95.0|-97.0|-67.0|||2-sided Wilcoxon Rank Sum|||||-67.00|-97.00|0.025
71783364|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-37.0||||0.074|TWO_SIDED|95.0|-66.0|5.0|||2-sided Wilcoxon Rank Sum|||||5.00|-66.00|0.074
71783365|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-10.5||||0.1066|TWO_SIDED|95.0|-59.0|10.0|||2-sided Wilcoxon Rank Sum|||||10.00|-59.00|0.1066
71783366|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0219|TWO_SIDED|95.0|-87.0|-71.0|||2-sided Wilcoxon Rank Sum|||||-71.00|-87.00|0.0219
71783367|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-78.0||||0.0262|TWO_SIDED|95.0|-83.0|-74.0|||2-sided Wilcoxon Rank Sum|||||-74.0|-83.00|0.0262
71783368|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-50.0||||0.0412|TWO_SIDED|95.0|-65.0|0.0|||2-sided Wilcoxon Rank Sum|||||0.00|-65.00|0.0412
71783369|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-89.5||||0.0269|TWO_SIDED|95.0|-93.0|-77.0|||2-sided Wilcoxon Rank Sum|||||-77.00|-93.00|0.0269
71783370|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-84.0||||0.0026|TWO_SIDED|95.0|-86.0|-69.0|||2-sided Wilcoxon Rank Sum|||||-69.00|-86.00|0.0026
71783371|NCT03310021|143065430|SUPERIORITY||Hodges lehman Location shift|-65.0||||0.0181|TWO_SIDED|95.0|-76.0|-57.0|||2-sided Wilcoxon Rank Sum|||||-57.00|-76.00|0.0181
71783372|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-81.06||||0.0282|TWO_SIDED|95.0|-92.99|-71.96|||2-sided Wilcoxon Rank Sum|||||-71.96|-92.99|0.0282
71783373|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-69.15||||0.0282|TWO_SIDED|95.0|-96.91|-48.64|||2-sided Wilcoxon Rank Sum|||||-48.64|-96.91|0.0282
71783374|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-57.39||||0.0085|TWO_SIDED|95.0|-72.07|-40.03|||2-sided Wilcoxon Rank Sum|||||-40.03|-72.07|0.0085
71783375|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-54.96||||0.0085|TWO_SIDED|95.0|-80.42|-25.5|||2-sided Wilcoxon Rank Sum|||||-25.50|-80.42|0.0085
71783376|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-100.25||||0.0282|TWO_SIDED|95.0|-133.08|-84.48|||2-sided Wilcoxon Rank Sum|||||-84.48|-133.08|0.0282
71783377|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-79.87||||0.0282|TWO_SIDED|95.0|-86.36|-65.74|||2-sided Wilcoxon Rank Sum|||||-65.74|-86.36|0.0282
71668860|NCT03135015|142854098|OTHER||Percentage Change from Control|-30.32||||0.0887|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0887
71783378|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-65.02||||0.0085|TWO_SIDED|95.0|-89.54|-39.17|||2-sided Wilcoxon Rank Sum|||||-39.17|-89.54|0.0085
71783379|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-91.29||||0.0282|TWO_SIDED|95.0|-128.88|-60.83|||2-sided Wilcoxon Rank Sum|||||-60.83|-128.88|0.0282
71845366|NCT05037513|143204861|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
71845367|NCT05037513|143204862|SUPERIORITY||Odds Ratio (OR)|7.06|||<|0.05|TWO_SIDED|95.0|0.8|62.2|||Regression, Logistic|||||62.2|0.8|<0.05
71783380|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-81.49||||0.0034|TWO_SIDED|95.0|-91.05|-65.96|||2-sided Wilcoxon Rank Sum|||||-65.96|-91.05|0.0034
71783381|NCT03310021|143065431|SUPERIORITY||Hodges lehman Location shift|-58.47||||0.0189|TWO_SIDED|95.0|-110.86|-46.12|||2-sided Wilcoxon Rank Sum|||||-46.12|-110.86|0.0189
71891713|NCT02514044|143304847|OTHER|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.02|TWO_SIDED|95.0|||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.||||0.02
71891714|NCT03093155|143304851|SUPERIORITY||Hazard Ratio (HR)|0.31|||<|0.001|TWO_SIDED|90.0|0.2|0.49|||Regression, Cox|||||0.49|0.20|<0.001
71668861|NCT03135015|142854098|OTHER||Percentage Change from Control|-39.96||||0.0266|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0266
71783382|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-59.39||||0.0282|TWO_SIDED|95.0|-66.48|-52.62|||2-sided Wilcoxon Rank Sum|||||-52.62|-66.48|0.0282
71783383|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-59.26||||0.0282|TWO_SIDED|95.0|-70.34|-26.94|||2-sided Wilcoxon Rank Sum|||||-26.94|-70.34|0.0282
71783384|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-36.76||||0.0085|TWO_SIDED|95.0|-46.14|-29.76|||2-sided Wilcoxon Rank Sum|||||-29.76|-46.14|0.0085
71783385|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-36.82||||0.0085|TWO_SIDED|95.0|-55.81|-20.46|||2-sided Wilcoxon Rank Sum|||||-20.46|-55.81|0.0085
71783386|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-61.67||||0.0282|TWO_SIDED|95.0|-75.82|-43.78|||2-sided Wilcoxon Rank Sum|||||-43.78|-75.82|0.0282
71783387|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-67.63||||0.0282|TWO_SIDED|95.0|-77.4|-61.99|||2-sided Wilcoxon Rank Sum|||||-61.99|-77.40|0.0282
71783388|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-40.33||||0.0085|TWO_SIDED|95.0|-59.77|-11.17|||2-sided Wilcoxon Rank Sum|||||-11.17|-59.77|0.0085
71783389|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-59.18||||0.0282|TWO_SIDED|95.0|-101.02|-48.14|||2-sided Wilcoxon Rank Sum|||||-48.14|-101.02|0.0282
71783390|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-54.63||||0.0027|TWO_SIDED|95.0|-59.14|-41.19|||2-sided Wilcoxon Rank Sum|||||-41.19|-59.14|0.0027
71783391|NCT03310021|143065432|SUPERIORITY||Hodges lehman Location shift|-38.14||||0.0189|TWO_SIDED|95.0|-65.78|-15.37|||2-sided Wilcoxon Rank Sum|||||-15.37|-65.78|0.0189
71891715|NCT03093155|143304852|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
71783392|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|965.09||||0.0282|TWO_SIDED|95.0|474.48|1377.35|||2-sided Wilcoxon Rank Sum|||||1377.35|474.48|0.0282
71783393|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|1127.29||||0.0282|TWO_SIDED|95.0|769.46|1575.02|||2-sided Wilcoxon Rank Sum|||||1575.02|769.46|0.0282
71783394|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|574.89||||0.0085|TWO_SIDED|95.0|307.65|1175.28|||2-sided Wilcoxon Rank Sum|||||1175.28|307.65|0.0085
71783395|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|715.34||||0.0085|TWO_SIDED|95.0|535.38|836.4|||2-sided Wilcoxon Rank Sum|||||836.40|535.38|0.0085
71783396|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|1141.17||||0.0282|TWO_SIDED|95.0|964.03|1736.78|||2-sided Wilcoxon Rank Sum|||||1736.78|964.03|0.0282
71783397|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|1198.83||||0.0282|TWO_SIDED|95.0|988.82|1670.3|||2-sided Wilcoxon Rank Sum|||||1670.30|988.82|0.0282
71783398|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|721.21||||0.0085|TWO_SIDED|95.0|585.92|1108.92|||2-sided Wilcoxon Rank Sum|||||1108.92|585.92|0.0085
71783399|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|1204.62||||0.0282|TWO_SIDED|95.0|1001.72|1471.45|||2-sided Wilcoxon Rank Sum|||||1471.45|1001.72|0.0282
71783400|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|1180.5||||0.0027|TWO_SIDED|95.0|857.21|1296.02|||2-sided Wilcoxon Rank Sum|||||1296.02|857.21|0.0027
71783401|NCT03310021|143065433|SUPERIORITY||Hodges lehman Location shift|976.59||||0.0189|TWO_SIDED|95.0|585.99|1498.37|||2-sided Wilcoxon Rank Sum|||||1498.37|585.99|0.0189
71783402|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|826.9||||0.0282|TWO_SIDED|95.0|505.4|1362.11|||2-sided Wilcoxon Rank Sum|||||1362.11|505.40|0.0282
71783403|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|1125.7||||0.0282|TWO_SIDED|95.0|873.87|1552.77|||2-sided Wilcoxon Rank Sum|||||1552.77|873.87|0.0282
71783404|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|538.84||||0.0085|TWO_SIDED|95.0|291.2|1077.46|||2-sided Wilcoxon Rank Sum|||||1077.46|291.20|0.0085
71783405|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|687.57||||0.0085|TWO_SIDED|95.0|500.92|902.73|||2-sided Wilcoxon Rank Sum|||||902.73|500.92|0.0085
71783406|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|1012.45||||0.0282|TWO_SIDED|95.0|859.08|1352.05|||2-sided Wilcoxon Rank Sum|||||1352.05|859.08|0.0282
71783407|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|1057.27||||0.0282|TWO_SIDED|95.0|818.96|1634.3|||2-sided Wilcoxon Rank Sum|||||1634.30|818.96|0.0282
71783408|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|630.81||||0.0085|TWO_SIDED|95.0|421.78|1124.28|||2-sided Wilcoxon Rank Sum|||||1124.28|421.78|0.0085
71783409|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|925.84||||0.0282|TWO_SIDED|95.0|663.74|1216.28|||2-sided Wilcoxon Rank Sum|||||1216.28|663.74|0.0282
71783410|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|871.11||||0.0027|TWO_SIDED|95.0|631.67|1051.06|||2-sided Wilcoxon Rank Sum|||||1051.06|631.67|0.0027
71783411|NCT03310021|143065434|SUPERIORITY||Hodges lehman Location shift|874.44||||0.0189|TWO_SIDED|95.0|637.25|1412.21|||2-sided Wilcoxon Rank Sum|||||1412.21|637.25|0.0189
71891716|NCT03093155|143304853|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.018|TWO_SIDED|90.0|0.38|0.84|||Regression, Cox|||||0.84|0.38|0.018
71891717|NCT03093155|143304854|SUPERIORITY|||||||0.77|||||||Fisher Exact|||||||0.77
71751555|NCT00395746|143006290|SUPERIORITY_OR_OTHER||Least Squares Mean|-150.22|||<|0.0001||95.0|-186.32|-114.12||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-114.12|-186.32|<0.0001
71783412|NCT00622284|143065456|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.|Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.04||0.0005||97.5|0.13|0.31||Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.|ANCOVA|||Linagliptin versus Glimepiride||0.31|0.13|0.0005
71783413|NCT00622284|143065457|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0004||97.5|0.09|0.3||This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.|ANCOVA|||Linagliptin versus Glimepiride||0.30|0.09|0.0004
71783414|NCT00622284|143065458|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001||97.5|-2.91|-2.09||This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.|ANCOVA|||Linagliptin versus Glimepiride||-2.09|-2.91|<0.0001
71783415|NCT00622284|143065459|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||97.5|-3.17|-2.19||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|ANCOVA|||Linagliptin versus Glimepiride||-2.19|-3.17|<0.0001
71783416|NCT00622284|143065460|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
71783417|NCT00622284|143065461|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride||||<0.0001
71783418|NCT00622284|143065462|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.84|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001||95.0|3.51|10.16|||ANCOVA|||Linagliptin versus Glimepiride||10.16|3.51|<0.0001
71783419|NCT00622284|143065463|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.38|STANDARD_ERROR_OF_MEAN|1.97||0.0012||95.0|2.51|10.25|||ANCOVA|||Linagliptin versus Glimepiride||10.25|2.51|0.0012
71783420|NCT00622284|143065464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.625||||0.0004||95.0|0.482|0.811|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.811|0.482|0.0004
71668862|NCT03135015|142854098|OTHER||Percentage Change from Control|-41.8||||0.0455|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0455
71783421|NCT00622284|143065465|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.654||||0.003||95.0|0.494|0.866|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.866|0.494|0.0030
71783422|NCT00622284|143065466|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.648||||0.0025||95.0|0.489|0.859|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.859|0.489|0.0025
71783423|NCT00622284|143065467|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.689||||0.024||95.0|0.498|0.952|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.952|0.498|0.0240
71783424|NCT00622284|143065468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.0018||95.0|0.56|0.875|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride||0.875|0.560|0.0018
71783425|NCT00622284|143065469|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.47|STANDARD_ERROR_OF_MEAN|5.77||0.0918||95.0|-21.07|1.59|||ANCOVA|||Linagliptin versus Glimepiride||1.59|-21.07|0.0918
71783426|NCT01217801|143065533|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|93.77||||0.05|TWO_SIDED|90.0|89.15|98.63|||Regression, Linear|||Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CI||98.63|89.15|0.05
71783427|NCT00291577|143065537|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.89||||||90.0|80.34|121.73|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3. Due to the exploratory nature of the study, no statistical hypothesis testing was done since the primary purpose was to assess the tolerability of the combination of SU011248 with docetaxel.||121.73|80.34|
71783428|NCT00291577|143065537|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.96||||||90.0|59.76|112.41|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||112.41|59.76|
71783429|NCT00291577|143065537|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|97.81||||||90.0|80.44|118.94|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||118.94|80.44|
71891718|NCT03093155|143304855|SUPERIORITY|||||||0.068|||||||Fisher Exact|||The RECIST responses were categorized as SD/PD or NA compared to PR or Better as a binary outcome.||||0.068
71751556|NCT00395746|143006290|SUPERIORITY_OR_OTHER||Least Squares Mean|-111.15|||<|0.0001||95.0|-147.61|-74.68||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-74.68|-147.61|<0.0001
71751557|NCT00395746|143006291|SUPERIORITY_OR_OTHER||Least Squares Mean|-127.57||||||95.0|-166.91|-88.24|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-88.24|-166.91|
71751558|NCT00395746|143006291|SUPERIORITY_OR_OTHER||Least Squares Mean|-68.68||||||95.0|-108.91|-28.45|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-28.45|-108.91|
71751559|NCT00395746|143006292|SUPERIORITY_OR_OTHER||Least Squares Mean|-44.45|||<|0.0001||95.0|-55.02|-33.89||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-33.89|-55.02|<0.0001
71751560|NCT00395746|143006292|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.3|||<|0.0001||95.0|-45.06|-23.54||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-23.54|-45.06|<0.0001
71751561|NCT00395746|143006293|SUPERIORITY_OR_OTHER||Least Squares Mean|-34.49||||||95.0|-46.77|-22.22|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-22.22|-46.77|
71751562|NCT00395746|143006293|SUPERIORITY_OR_OTHER||Least Squares Mean|-46.34||||||95.0|-58.49|-34.18|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-34.18|-58.49|
71783430|NCT00291577|143065538|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.23||||||90.0|82.75|123.83|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3||123.83|82.75|
71783431|NCT00291577|143065538|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|81.72||||||90.0|62.4|107.04|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3||107.04|62.40|
71783432|NCT00291577|143065538|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.0||||||90.0|82.95|120.56|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3||120.56|82.95|
71783433|NCT00291577|143065542|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|99.18||||||90.0|78.73|124.95|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||124.95|78.73|
71783434|NCT00291577|143065543|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.98||||||90.0|78.73|114.58|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.58|78.73|
71783435|NCT00291577|143065545|SUPERIORITY_OR_OTHER||rate (percent)|73.7||||||95.0|48.8|90.9|||||Two-sided Confidence Interval (CI) (%) from exact method based on F distribution.|Overall confirmed objective response rate (CR + PR)||90.9|48.8|
71783436|NCT00291577|143065546|SUPERIORITY_OR_OTHER||rate (percent)|89.5||||||95.0|66.9|98.7|||||Two-sided CI (%) from exact method based on F distribution.|Clinical Benefit Rate (CR + PR + SD \> = 24 weeks)||98.7|66.9|
71783437|NCT00291577|143065548|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.57||||||90.0|79.9|114.32|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.32|79.90|
71783438|NCT00291577|143065549|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|112.39||||||90.0|81.05|155.85|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||155.85|81.05|
71783439|NCT00291577|143065550|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.79||||||90.0|79.82|114.96|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1||114.96|79.82|
71783440|NCT04967443|143065555|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.1|||||TWO_SIDED|90.0|96.14|108.43|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.43|96.14|
71751563|NCT00395746|143006294|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.37||||0.0433||95.0|-22.4|-0.34||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||-0.34|-22.40|0.0433
71758529|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71896212|NCT01709799|143314374|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05|Mixed Models Analysis|Degrees of freedom are (4,90.564)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.995
71668863|NCT03135015|142854099|OTHER||Percentage Change from Control|-41.82||||0.0261|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0261
71758530|NCT02205736|143019221|SUPERIORITY|||||||0.0522||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0522
71783441|NCT04967443|143065555|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.87|||||TWO_SIDED|90.0|98.68|111.44|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||111.44|98.68|
71758531|NCT02205736|143019221|SUPERIORITY|||||||0.8185||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8185
71668864|NCT03135015|142854099|OTHER||Percentage Change from Control|-36.45||||0.0391|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0391
71758532|NCT02205736|143019221|SUPERIORITY|||||||0.0005||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0005
71758533|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Subjects recorded True/False answers to Q25 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The contingency table of 329 responses to Q25 displayed the following: N=260 Correct at Baseline and Correct at Post-Intervention (79.0%), N=7 Correct at Baseline and Incorrect at Post-Intervention (2.1%), N=49 Incorrect at Baseline and Correct at Post-Intervention (14.9%), N=13 Incorrect at Baseline and Incorrect at Post-Intervention (4.0%).||||<.0001
71758534|NCT02205736|143019222|SUPERIORITY|||||||0.2482||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2482
71758535|NCT02205736|143019222|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71896213|NCT01709799|143314375|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,97.137)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<.001
71783442|NCT04967443|143065555|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.45|||||TWO_SIDED|90.0|99.58|109.55|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.55|99.58|
71783443|NCT04967443|143065556|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|113.96|||||TWO_SIDED|90.0|102.79|126.34|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||126.34|102.79|
71783444|NCT04967443|143065556|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|126.83|||||TWO_SIDED|90.0|114.32|140.7|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||140.70|114.32|
71783445|NCT04967443|143065556|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|118.07|||||TWO_SIDED|90.0|106.46|130.94|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||130.94|106.46|
71783446|NCT04967443|143065557|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|100.91|||||TWO_SIDED|90.0|94.92|107.27|||Mixed Models Analysis|||Test: Prazosin HCL 1x2 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||107.27|94.92|
71783447|NCT04967443|143065557|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|102.08|||||TWO_SIDED|90.0|95.97|108.57|||Mixed Models Analysis|||Test: Prazosin HCL 2x1 mg (Ascoli); Reference: Prazosin HCL 1x2 mg (Barceloneta)||108.57|95.97|
71783448|NCT04967443|143065557|EQUIVALENCE|Bioequivalence will be demonstrated if the estimated 90% confidence interval for the ratios (Test/Reference) of adjusted geometric means for AUClast and Cmax fall entirely within (80%, 125%).|Ratio of adjusted geometric means|104.04|||||TWO_SIDED|90.0|99.09|109.23|||Mixed Models Analysis|||Test: Prazosin HCL 1x5 mg (Ascoli); Reference: Prazosin HCL 1x5 mg (Barceloneta)||109.23|99.09|
71783449|NCT04502693|143065561|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE (Vaccine Effectiveness)|83.2|||||TWO_SIDED|97.5|81.9|84.4||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||84.4|81.9|
71783450|NCT04502693|143065561|OTHER|"Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_ 6 and the ACWY groups is above 65%.~VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage."|VE|81.8|||||TWO_SIDED|97.5|80.4|83.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB\_0\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||83.1|80.4|
71783451|NCT04502693|143065562|OTHER|Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\_0\_2\_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|78.7|||||TWO_SIDED|97.5|77.2|80.1||||||To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB\_0\_2\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.||80.1|77.2|
71783452|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.10|0.84|
71783453|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.75|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||0.98|0.75|
71783454|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.9|||||TWO_SIDED|95.0|0.78|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).||1.02|0.78|
71668865|NCT03135015|142854099|OTHER||Percentage Change from Control|-82.11||||0.0372|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0372
71668866|NCT03135015|142854099|OTHER||Percentage Change from Control|-55.81||||0.1631|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.1631
71751564|NCT00395746|143006294|SUPERIORITY_OR_OTHER||Least Squares Mean|6.67||||0.2359||95.0|-4.39|17.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||17.73|-4.39|0.2359
71751565|NCT00395746|143006295|SUPERIORITY_OR_OTHER||Least Squares Mean|-13.3||||||95.0|-24.69|-1.9|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||-1.90|-24.69|
71751566|NCT00395746|143006295|SUPERIORITY_OR_OTHER||Least Squares Mean|-7.11||||||95.0|-18.42|4.21|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||4.21|-18.42|
71751567|NCT00395746|143006296|SUPERIORITY_OR_OTHER||Least Squares Mean|0.75||||0.0071||95.0|0.21|1.3||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.30|0.21|0.0071
71751568|NCT00395746|143006296|SUPERIORITY_OR_OTHER||Least Squares Mean|1.18|||<|0.0001||95.0|0.63|1.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."||1.73|0.63|<0.0001
71751569|NCT00395746|143006297|SUPERIORITY_OR_OTHER||Least Squares Mean|1.04||||||95.0|0.42|1.66|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.||1.66|0.42|
71751570|NCT00395746|143006297|SUPERIORITY_OR_OTHER||Least Squares Mean|1.13||||||95.0|0.51|1.75|||ANOVA|||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed||1.75|0.51|
71751571|NCT00395746|143006298|SUPERIORITY_OR_OTHER||Rate ratio|1.59||||||95.0|0.86|2.96|||Negative binomial regression|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.96|0.86|
71751572|NCT00395746|143006298|SUPERIORITY_OR_OTHER||Rate ratio|1.18||||||95.0|0.56|2.47|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.47|0.56|
71751573|NCT00395746|143006298|SUPERIORITY_OR_OTHER||Rate ratio|1.8||||||95.0|0.92|3.54|||Negative binomial regression model|||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.54|0.92|
71783455|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.92|||||TWO_SIDED|95.0|0.76|1.11||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.11|0.76|
71668867|NCT03135015|142854100|OTHER||Percentage Change from Control|-46.43||||0.0303|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.0303
71668868|NCT03135015|142854100|OTHER||Percentage Change from Control|-19.64||||0.4283|TWO_SIDED||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.||||0.4283
71668869|NCT01197911|142854114|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.148|||||TWO_SIDED|90.0|0.9293|1.4182||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.4182|0.9293|
71891719|NCT00619229|143304857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.122|TWO_SIDED|95.0|-0.674|2.55||The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.|ANCOVA||For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors 'treatment' and 'centre' and Baseline value as a covariate was used.|"The primary goal of the study was to test the following null hypothesis:~H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil \> μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts."||2.55|-0.674|0.1220
71668870|NCT01197911|142854114|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5518|||||TWO_SIDED|90.0|1.2468|1.9314||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9314|1.2468|
71668871|NCT01197911|142854116|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|0.9477|||||TWO_SIDED|90.0|0.7908|1.1356||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.1356|0.7908|
71668872|NCT01197911|142854116|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0782|||||TWO_SIDED|90.0|0.8941|1.3002||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.3002|0.8941|
71668873|NCT01197911|142854130|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.2323|||||TWO_SIDED|90.0|0.9618|1.5789||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.5789|0.9618|
71668874|NCT01197911|142854130|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.5587|||||TWO_SIDED|90.0|1.2165|1.9971||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.9971|1.2165|
71668875|NCT01197911|142854131|SUPERIORITY_OR_OTHER||Geometric Least-Squares Mean Ratio|1.0027|||||TWO_SIDED|90.0|0.8049|1.2492||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.||1.2492|0.8049|
71668876|NCT01197911|142854131|SUPERIORITY_OR_OTHER||GeometricLeast-Squares Mean Ratio|1.2254|||||TWO_SIDED|90.0|0.9836|1.5266||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.||1.5266|0.9836|
71668877|NCT02443740|142854163|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|39.58|||||TWO_SIDED|90.0|30.14|51.99|||||Values have been back-transformed from the log scale.|||51.99|30.14|
71668878|NCT02443740|142854164|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.6|||||TWO_SIDED|90.0|59.74|108.75|||||Values have been back-transformed from the log scale.|||108.75|59.74|
71668879|NCT02443740|142854165|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|80.12|||||TWO_SIDED|90.0|58.92|108.94|||||Values have been back-transformed from the log scale.|||108.94|58.92|
71668880|NCT02443740|142854170|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|65.58|||||TWO_SIDED|90.0|62.18|69.16|||||Values have been back-transformed from the log scale.|||69.16|62.18|
71668881|NCT02443740|142854171|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|68.62|||||TWO_SIDED|90.0|63.27|74.41|||||Values have been back-transformed from the log scale.|||74.41|63.27|
71668882|NCT02443740|142854172|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio.|29.76|||||TWO_SIDED|90.0|24.17|36.64|||||Values have been back-transformed from the log scale.|||36.64|24.17|
71783456|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.41|0.97|
71668883|NCT02443740|142854174|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|16.71|||||TWO_SIDED|90.0|15.35|18.18|||||Values were back-transformed from the log scale.|||18.18|15.35|
71668884|NCT02443740|142854176|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric Mean Ratio|15.21|||||TWO_SIDED|90.0|13.29|17.42|||||Values were back-transformed from the log scale.|||17.42|13.29|
71668885|NCT01074944|142854189|NON_INFERIORITY_OR_EQUIVALENCE|Eliglustat QD treatment was declared non-inferior to BID treatment if the lower bound of the 95% confidence interval (CI) for the difference was within the non-inferiority margin of -0.15 (or -15%).|Difference in Percentage Stable|-2.7|||||TWO_SIDED|95.0|-17.7|11.9||||||||11.9|-17.7|
71668886|NCT02348112|142854230|NON_INFERIORITY|The number and proportion of subjects experiencing a 50% or greater reduction in pad weight at 6 months were compared, and non-inferiority assessed using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the 95% confidence interval for the difference in proportions (Comparator - Altis) was less than 0.15.|Difference in Proportions|-0.054||||0.013|TWO_SIDED|95.0|-0.139|0.031|||Normal approximation test (Z-test)|||||0.031|-0.139|0.013
71677098|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.3||||0.1971|TWO_SIDED|95.0|-8.31|1.74||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||1.74|-8.31|0.1971
71751574|NCT00395746|143006298|SUPERIORITY_OR_OTHER||Rate ratio|1.62||||||95.0|0.85|3.07|||Negative binomial regression model|||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.07|0.85|
71751575|NCT00395746|143006298|SUPERIORITY_OR_OTHER||Rate ratio|1.48||||||95.0|0.69|3.17|||Negative binomial regression model|||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||3.17|0.69|
71751576|NCT00395746|143006298|SUPERIORITY_OR_OTHER||Rate ratio|1.45||||||95.0|0.72|2.91|||Negative binomial regression model|||The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.||2.91|0.72|
71751577|NCT03137992|143006303|EQUIVALENCE|Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.|Least Squared Mean Ratio|0.9369|||||TWO_SIDED|90.0|0.834|1.047|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the Lupin Tiotropium and Spiriva Handihaler LS mean ratio.|A blinded interim analysis was performed after 241 subjects had been randomized with measurable AUC data, which estimated 238 patients would be needed to demonstrate BE with 90% power. Therefore, it was planned that approximately 378 patients would be randomized to allow for a potential 30% loss/withdrawal from the PP population.||1.047|0.834|
71751578|NCT03137992|143006304|SUPERIORITY||Least Squared Mean Difference|3.29|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|2.9386|3.646||Efficacy of the Test (T) product was demonstrated if the T was shown to be statistically superior to Placebo (p\<0.05 \[two-tailed\]).Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.646|2.9386|<0.001
71751579|NCT03137992|143006304|SUPERIORITY||Least Squared Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|3.0718|3.7797||Study sensitivity was demonstrated if the Reference (R) product was shown to be statistically superior to Placebo (P) (p \<0.05 \[two-tailed\]). Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.|Mixed Models Analysis|Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.||||3.7797|3.0718|<0.001
71751580|NCT00795704|143006319|SUPERIORITY_OR_OTHER|||||||0.079|||||||t-test, 2 sided|||||||0.079
71751581|NCT00795704|143006321|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71751582|NCT03980730|143006322|SUPERIORITY|||||||0.2057|||||||Mixed Models Analysis|||||||0.2057
71751583|NCT02392806|143006333|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71751584|NCT03125226|143006337|OTHER|Single group mean and standard deviation||||||||||||||||Coordinates in x/y/z planes were assigned to each hydrogel marker on the planning CT and daily CBCT to calculate interfraction motion.|Single group mean and standard deviation|||
71751585|NCT03125226|143006342|OTHER|The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||||||||||||||||The Van Herk (VH) margin equation for the planning target volume margin, as a function of systemic and random errors, was calculated such that the CTV receives at least 95%-prescription dose in 90% of patients.|||
71751586|NCT03883581|143006343|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71751587|NCT03883581|143006344|SUPERIORITY|||||||0.647|||||||Paired t test|||||||0.647
71751588|NCT03883581|143006345|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
71751589|NCT03883581|143006346|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
71751590|NCT03883581|143006347|SUPERIORITY|||||||0.103|||||||Paired t test|||||||0.103
71751591|NCT04612725|143006348|SUPERIORITY||LS mean difference|-1.01||||0.3824|TWO_SIDED|95.0|-3.28|1.26||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.26|-3.28|0.3824
71751592|NCT04612725|143006348|SUPERIORITY||LS mean difference|-1.79||||0.1244|TWO_SIDED|95.0|-4.09|0.5||Change from baseline in ISS7 at Week 12= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.50|-4.09|0.1244
71751593|NCT04612725|143006349|SUPERIORITY||LS mean difference|-2.07||||0.4016|TWO_SIDED|95.0|-6.95|2.8||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.80|-6.95|0.4016
71751594|NCT04612725|143006349|SUPERIORITY||LS mean difference|-4.36||||0.0819|TWO_SIDED|95.0|-9.28|0.56||Change from baseline in UAS7 at Week 12= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.56|-9.28|0.0819
71751595|NCT04612725|143006349|SUPERIORITY||LS mean difference|-2.56||||0.3314|TWO_SIDED|95.0|-7.74|2.63||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.63|-7.74|0.3314
71751596|NCT04612725|143006349|SUPERIORITY||LS mean difference|-3.74||||0.1582|TWO_SIDED|95.0|-8.95|1.47||Change from baseline in UAS7 at Week 24= Treatment + baseline UAS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.47|-8.95|0.1582
71751597|NCT04612725|143006350|SUPERIORITY||LS mean difference|-1.62||||0.1995|TWO_SIDED|95.0|-4.1|0.86||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.86|-4.10|0.1995
71751598|NCT04612725|143006350|SUPERIORITY||LS mean difference|-1.76||||0.1654|TWO_SIDED|95.0|-4.25|0.73||Change from baseline in ISS7 at Week 24= Treatment + baseline ISS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.73|-4.25|0.1654
71751599|NCT04612725|143006351|SUPERIORITY||percentage difference|11.72||||0.1373|TWO_SIDED|95.0|-2.37|25.82||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||25.82|-2.37|0.1373
71751600|NCT04612725|143006351|SUPERIORITY||percentage difference|10.73||||0.1697|TWO_SIDED|95.0|-3.42|24.88||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||24.88|-3.42|0.1697
71668887|NCT02348112|142854231|NON_INFERIORITY|The number and proportion of subjects experiencing device- and/or procedure-related serious adverse events were tabulated for each study group. Non-inferiority through 36 months was calculated using a normal approximation test (Z-test) for a difference in binomial proportion. Non-inferiority was considered achieved if the lower limit of the 95% confidence interval for the difference in proportions (Comparator - Altis) is greater than -0.10 in the mITT analysis population.|Difference in Proportions|0.013|||<|0.0001|TWO_SIDED|95.0|-0.023|0.048|||Normal approximation test (Z-test)|||||0.048|-0.023|<0.0001
71668888|NCT03741400|142854232|OTHER|||||||0.88||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.88
71783457|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|1.27|||||TWO_SIDED|95.0|1.05|1.54||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).||1.54|1.05|
71783458|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
71668889|NCT03741400|142854232|OTHER|||||||0.99||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.99
71668890|NCT03741400|142854232|OTHER|||||||0.8||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.80
71783459|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.77|1.02||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.02|0.77|
71783460|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.86|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).||1.14|0.86|
71783461|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.86|||||TWO_SIDED|95.0|0.73|1.01||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.01|0.73|
71783462|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.83|||||TWO_SIDED|95.0|0.71|0.98||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||0.98|0.71|
71783463|NCT04502693|143065565|EQUIVALENCE|Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \[0.5;2.0\] equivalence interval for each pair of lots.|GMT ratio|0.97|||||TWO_SIDED|95.0|0.82|1.14||||||To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).||1.14|0.82|
71783464|NCT04502693|143065566|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|11.29|||||TWO_SIDED|95.0|5.88|19.01|||Difference in percentage of participants|||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||19.01|5.88|
71783465|NCT04502693|143065566|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|47.22|||||TWO_SIDED|95.0|38.14|56.3||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||56.30|38.14|
71783466|NCT04502693|143065566|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|35.31|||||TWO_SIDED|95.0|26.88|44.49||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||44.49|26.88|
71668891|NCT03741400|142854233|OTHER|||||||0.61||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.61
71668892|NCT03741400|142854234|OTHER|||||||0.47||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in total seconds||||0.47
71668893|NCT03741400|142854234|OTHER|||||||0.55||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in fine motor skill assessment||||0.55
71668894|NCT03741400|142854234|OTHER|||||||0.38||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis of change in gross motor skills assessment||||0.38
71783467|NCT04502693|143065566|NON_INFERIORITY|Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.|Difference in percentage of participants|26.99|||||TWO_SIDED|95.0|19.38|35.81||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.||35.81|19.38|
71783468|NCT04502693|143065567|OTHER|Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY\_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.|VE|77.9|||||TWO_SIDED|95.0|76.6|79.2||||||To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.||79.2|76.6|
71783469|NCT04502693|143065568|NON_INFERIORITY|Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.|Difference in percentage of participants|-0.61|||||TWO_SIDED|95.0|-1.25|0.03||||||To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.||0.03|-1.25|
71783470|NCT00602797|143065599|OTHER|An interim analysis was conducted after 10 patients were accrued. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.|Proportion|6.0|||||TWO_SIDED||||||||If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated.|Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).||||
71783471|NCT03473977|143065601|OTHER|||||||0.0001|||||||Fisher Exact|||||||0.0001
71783472|NCT03473977|143065602|OTHER|||||||0.75|||||||Kruskal-Wallis|||||||0.75
71836029|NCT03526861|143177409|SUPERIORITY|This secondary endpoint was tested sequentially using the Holm-Bonferroni method for multiplicity adjustment at a 5% significance level after the sequential testing of the primary endpoints and first secondary endpoint, if these showed statistical significance.|Difference of least square means|-2.0||||0.04|TWO_SIDED|95.0|-3.9|-0.1||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.1|-3.9|0.040
71783473|NCT03473977|143065603|OTHER|||||||0.006|||||||Kruskal-Wallis|||||||0.006
71783474|NCT03473977|143065604|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71783475|NCT03473977|143065605|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
71783476|NCT03473977|143065606|OTHER|||||||0.014|||||||Kruskal-Wallis|||||||0.014
71783477|NCT03473977|143065607|OTHER|||||||0.78|||||||Kruskal-Wallis|||Pain Score Comparison||||0.78
71783478|NCT03473977|143065607|OTHER|||||||0.34|||||||Kruskal-Wallis|||Non-pain score comparison||||0.34
71783479|NCT03473977|143065607|OTHER|||||||0.66|||||||Kruskal-Wallis|||Satisfaction score comparison||||0.66
71668895|NCT03741400|142854235|OTHER|||||||0.24||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||||||0.24
71668896|NCT03741400|142854236|OTHER|||||||0.18||||||A priori threshold for statistical significance, 0.05|Mann-Whitney U test|||||||0.18
71783480|NCT00418457|143065635|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.74|1.28|||Regression, Cox|||||1.28|0.74|0.84
71783481|NCT00418457|143065636|SUPERIORITY||Odds Ratio (OR)|1.0||||0.7|TWO_SIDED|95.0|0.85|1.17|||GEE|||||1.17|0.85|0.70
71668897|NCT03741400|142854237|OTHER|||||||0.926||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 12||||0.926
71668898|NCT03741400|142854237|OTHER|||||||0.828||||||A priori threshold for statistical significance, 0.05|ANCOVA|Nonparametric ANCOVA using Quade's test with adjustments for age, sex, and NIHSS||Analysis at week 24||||0.828
71668899|NCT03714828|142854238|OTHER||Overall Response Rate|100.0||||0.0005|ONE_SIDED|95.0|76.2||||One-sample binomial test|One-sample binomial test versus null hypothesis value of 0.50.|||||76.2|0.0005
71783482|NCT00418457|143065637|SUPERIORITY||Odds Ratio (OR)|0.98||||0.81|TWO_SIDED|95.0|0.75|1.28|||GEE|||||1.28|0.75|0.81
71783483|NCT00418457|143065638|SUPERIORITY||Mean Difference (Final Values)|-0.014||||0.96|TWO_SIDED|95.0|-0.63|0.6|||Mixed Models Analysis|||||0.60|-0.63|0.96
71783484|NCT00418457|143065639|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.043|TWO_SIDED|95.0|0.02|1.48|||Mixed Models Analysis|||||1.48|0.02|0.043
71783485|NCT03547583|143065645|OTHER||Difference of LS-means|-0.52|||=|0.8008|TWO_SIDED|97.5|-5.17|4.13|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||4.13|-5.17|= 0.8008
71668900|NCT03714828|142854240|OTHER|Descriptive statistics|Mean|48.7|STANDARD_DEVIATION|29.2|||TWO_SIDED|||||||||||||
71836030|NCT03526861|143177412|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|38.5|||<|0.001|TWO_SIDED|95.0|26.8|50.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||50.2|26.8|<0.001
71896214|NCT01709799|143314375|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,97.108)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.254
71668901|NCT03714828|142854242|OTHER|Binomial proportion of TILs|Percentage|83.3|||||TWO_SIDED|||||||||||||
71668902|NCT03714828|142854245|OTHER|Counts of TILs|Percentage|100.0|||||TWO_SIDED|||||||||||||
71668903|NCT03714828|142854246|OTHER||Percentage|100.0|||||TWO_SIDED|||||||||||||
71751601|NCT04612725|143006351|SUPERIORITY||percentage difference|1.03||||0.9105|TWO_SIDED|95.0|-16.9|18.96||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||18.96|-16.90|0.9105
71751602|NCT04612725|143006351|SUPERIORITY||percentage difference|9.27||||0.3389|TWO_SIDED|95.0|-9.37|27.9||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||27.90|-9.37|0.3389
71751603|NCT04612725|143006352|SUPERIORITY||LS mean difference|-1.16||||0.4203|TWO_SIDED|95.0|-4.0|1.68||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.68|-4.00|0.4203
71751604|NCT04612725|143006352|SUPERIORITY||LS mean difference|-2.6||||0.0754|TWO_SIDED|95.0|-5.46|0.27||Change from baseline in HSS7 at Week 12= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.27|-5.46|0.0754
71751605|NCT04612725|143006352|SUPERIORITY||LS mean difference|-1.06||||0.4772|TWO_SIDED|95.0|-4.01|1.89||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.89|-4.01|0.4772
71751606|NCT04612725|143006352|SUPERIORITY||LS mean difference|-2.0||||0.1851|TWO_SIDED|95.0|-4.96|0.97||Change from baseline in HSS7 at Week 24= Treatment + baseline HSS7 + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||0.97|-4.96|0.1851
71751607|NCT04612725|143006354|SUPERIORITY|||||||0.9678||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.9678
71751608|NCT04612725|143006354|SUPERIORITY|||||||0.3689||||||Week 12: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||||0.3689
71751609|NCT04612725|143006354|SUPERIORITY||percentage difference|-3.43||||0.6624|TWO_SIDED|95.0|-18.96|12.11||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||12.11|-18.96|0.6624
71751610|NCT04612725|143006354|SUPERIORITY||percentage difference|0.28||||0.9726|TWO_SIDED|95.0|-15.84|16.4||Week 24: Estimates included treatment group, region (Europe, North America, Asia) and baseline UAS7.|Regression, Logistic|||||16.40|-15.84|0.9726
71751611|NCT04612725|143006356|SUPERIORITY||LS mean difference|-0.29||||0.7256|TWO_SIDED|95.0|-1.9|1.32||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.32|-1.90|0.7256
71751612|NCT04612725|143006356|SUPERIORITY||LS mean difference|1.09||||0.189|TWO_SIDED|95.0|-0.54|2.72||Change from baseline in UCT at Week 12= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.72|-0.54|0.1890
71751613|NCT04612725|143006356|SUPERIORITY||LS mean difference|-0.63||||0.5048|TWO_SIDED|95.0|-2.51|1.24||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.24|-2.51|0.5048
71751614|NCT04612725|143006356|SUPERIORITY||LS mean difference|0.99||||0.2991|TWO_SIDED|95.0|-0.89|2.88||Change from baseline in UCT at Week 24= Treatment + baseline UCT + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.88|-0.89|0.2991
71751615|NCT04612725|143006357|SUPERIORITY||LS mean difference|1.63||||0.5704|TWO_SIDED|95.0|-4.05|7.32||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||7.32|-4.05|0.5704
71751616|NCT04612725|143006357|SUPERIORITY||LS mean difference|-2.24||||0.4416|TWO_SIDED|95.0|-7.98|3.5||Change from baseline in CU-Q2oL at Week 12= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.50|-7.98|0.4416
71751617|NCT04612725|143006357|SUPERIORITY||LS mean difference|1.47||||0.6591|TWO_SIDED|95.0|-5.09|8.02||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||8.02|-5.09|0.6591
71751618|NCT04612725|143006357|SUPERIORITY||LS mean difference|-3.04||||0.3624|TWO_SIDED|95.0|-9.62|3.54||Change from baseline in CU-Q2oL at Week 24= Treatment + baseline CU-Q2oL + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.54|-9.62|0.3624
71751619|NCT04612725|143006358|SUPERIORITY||LS mean difference|0.48||||0.7037|TWO_SIDED|95.0|-2.02|2.98||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||2.98|-2.02|0.7037
71751620|NCT04612725|143006358|SUPERIORITY||LS mean difference|-1.25||||0.332|TWO_SIDED|95.0|-3.78|1.29||Change from baseline in DLQI at Week 12= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.29|-3.78|0.3320
71751621|NCT04612725|143006358|SUPERIORITY||LS mean difference|1.24||||0.359|TWO_SIDED|95.0|-1.42|3.9||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||3.90|-1.42|0.3590
71751622|NCT04612725|143006358|SUPERIORITY||LS mean difference|-0.88||||0.5175|TWO_SIDED|95.0|-3.56|1.8||Change from baseline in DLQI at Week 24= Treatment + baseline DLQI + region (Europe, North America, Asia) + visit + treatment by visit.|Mixed-effect model for repeated measures|||||1.80|-3.56|0.5175
71751623|NCT02354235|143006361|SUPERIORITY||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.15|-0.6|||ANCOVA|||||-0.60|-1.15|<0.001
71751624|NCT02354235|143006362|SUPERIORITY||Least Squares Mean Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-48.5|-29.2|||ANCOVA|||||-29.2|-48.5|<0.001
71751625|NCT02354235|143006363|SUPERIORITY||Least Squares Mean Difference|-2.33|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.2|-1.45|||ANCOVA|||||-1.45|-3.20|<0.001
71751626|NCT02354235|143006364|SUPERIORITY||Least Squares Mean Difference|-100.3|STANDARD_ERROR_OF_MEAN|11.1|<|0.001|TWO_SIDED|95.0|-122.2|-78.4|||ANCOVA|||||-78.4|-122.2|<0.001
71751627|NCT02354235|143006365|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-64.9|-36.9|||ANCOVA|||||-36.9|-64.9|<0.001
71751628|NCT01908426|143006385|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0049|TWO_SIDED|95.0|0.63|0.92|||Log Rank|The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.92|0.63|0.0049
71751629|NCT01908426|143006386|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.36|0.52|||Log Rank|The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.||||0.52|0.36|< 0.0001
71751630|NCT01908426|143006387|SUPERIORITY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||||||0.0086
71783486|NCT03547583|143065645|OTHER||Difference of LS-means|-1.46|||=|0.4722|TWO_SIDED|97.5|-6.02|3.1|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline PLS values as covariates.||3.10|-6.02|= 0.4722
71813102|NCT03720938|143128559|SUPERIORITY|||||||0||||||The outcome of body mass index z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index z score at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.000
71751631|NCT01782898|143006395|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.82
71751632|NCT01782898|143006396|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.05
71751633|NCT01782898|143006397|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.14
71751634|NCT05482308|143006403|OTHER||Mean differences(Test-Reference)|98.35|||||TWO_SIDED|90.0|92.92|104.1|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||104.10|92.92|
71751635|NCT05482308|143006404|OTHER||Mean difference (Test-Reference)|91.58|||||TWO_SIDED|90.0|81.5|102.9|||Mixed effect model|"Mixed effect model was fitted to obtain:~1.Adjusted mean differences 2.90% Confidence intervals(CI)"||||102.90|81.50|
71751636|NCT00416624|143006407|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.41|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.41
71751637|NCT00416624|143006409|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 80 patients per arm will provide\> 80% power to detect differences between average hemoglobin levels in the\> reference arm and another treatment of 50% of the standard deviation. Note that\> typically one would expect the estimates for the standard deviation at a single time\> point to differ from the standard deviation for the difference from baseline.|||||>|0.13|TWO_SIDED||||||Fisher Exact|||||||>0.13
71751638|NCT00416624|143006411|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the\> above sample size will provide an 80% power to detect a difference as small as\> 25%.|||||>|0.49|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be\> about 80% power to detect a difference through Fisher's exact test across two\> treatment arms of 25% in the true percentage of patients that experience a\> hematopoietic response as defined previously, if that percentage is at least 30% in\> the superior group, again with a 1.7% type I error rate.||||>0.49
71751639|NCT00416624|143006414|NON_INFERIORITY_OR_EQUIVALENCE|If the hematopoietic response rate in the standard therapy group is far from 50% (\<25% or \>75%), the above sample size will provide an 80% power to detect a difference as small as 25%.|||||>|0.56|TWO_SIDED||||||Fisher Exact|||With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.||||>0.56
71836031|NCT03526861|143177412|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|32.4|||<|0.001|TWO_SIDED|95.0|20.6|44.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||44.1|20.6|<0.001
71836032|NCT03526861|143177413|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|13.7||||0.002|TWO_SIDED|95.0|5.2|22.2||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||22.2|5.2|0.002
71836033|NCT03526861|143177413|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.3|||<|0.001|TWO_SIDED|95.0|6.5|24.1||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 90% reduction in EASI at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||24.1|6.5|<0.001
71845368|NCT00092534|143204895|SUPERIORITY_OR_OTHER_LEGACY||Percent relative risk reduction|96.6||||||95.0|88.2|99.6|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||99.6|88.2|
71783487|NCT03547583|143065646|OTHER||Difference of LS-means|-1.81|||=|0.8054|TWO_SIDED|97.5|-18.3|14.67|||Mixed model repeated-measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||14.67|-18.30|= 0.8054
71783488|NCT03547583|143065646|OTHER||Difference of LS-means|-5.49|||=|0.4502|TWO_SIDED|97.5|-21.77|10.8|||mixed model repeated measures|||The analysis of each imputed dataset will be performed using mixed-effects model for repeated measures (MMRM), including treatment, region, heart rhythm, study visit as fixed effects, interaction between study visit and treatment group, and adjustment for the baseline 6MWT values as covariates.||10.80|-21.77|= 0.4502
71783489|NCT02657915|143065651|SUPERIORITY||Mean Difference (Final Values)|-6.0|||=|0.165|TWO_SIDED|95.0|-14.56|2.57|||ANCOVA|||||2.57|-14.56|=0.165
71783490|NCT01703039|143065659|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
71783491|NCT01703039|143065660|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71783492|NCT01703039|143065661|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||0.34
71783493|NCT01703039|143065662|SUPERIORITY|||||||0.27|||||||ANOVA|||||||0.27
71783494|NCT01703039|143065663|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
71783495|NCT03291808|143065698|OTHER|||||||0.35|||||||Kruskal-Wallis|||||||.35
71783496|NCT01397084|143065733|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.||||<0.001
71783497|NCT00618072|143065737|SUPERIORITY_OR_OTHER|||||||0.181|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.181
71783498|NCT00618072|143065737|SUPERIORITY_OR_OTHER|||||||0.026|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.026
71783499|NCT00618072|143065737|SUPERIORITY_OR_OTHER|||||||0.063|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.063
71783500|NCT00618072|143065738|SUPERIORITY_OR_OTHER|||||||0.049|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.049
71845369|NCT04001829|143204922|SUPERIORITY|||||||0.27|||||||Fisher Exact|||||||0.27
71845370|NCT04001829|143204923|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71845371|NCT04001829|143204924|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71845372|NCT04001829|143204925|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71845373|NCT04001829|143204926|SUPERIORITY|||||||0.019|||||||Fisher Exact|||||||0.019
71845374|NCT04001829|143204927|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71845375|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.485|0.939|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.939|0.485|
71845376|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.689|||||TWO_SIDED|95.0|0.467|0.911|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.911|0.467|
71845377|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.517|1.051|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||1.051|0.517|
71845378|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.759|||||TWO_SIDED|95.0|0.497|1.02|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||1.020|0.497|
71845379|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.567|0.973|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.973|0.567|
71845380|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.745|||||TWO_SIDED|95.0|0.547|0.943|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.943|0.547|
71783501|NCT00618072|143065738|SUPERIORITY_OR_OTHER|||||||0.002|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.002
71845381|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.353|0.896|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||0.896|0.353|
71845382|NCT03678688|143204928|SUPERIORITY||EBA Ratio|0.605|||||TWO_SIDED|95.0|0.338|0.871|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||0.871|0.338|
71845383|NCT03678688|143204968|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.626|3.175|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||3.175|0.626|
71845384|NCT03678688|143204968|SUPERIORITY||EBA Ratio|1.256|||||TWO_SIDED|95.0|0.362|2.151|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.151|0.362|
71845385|NCT03678688|143204968|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.736|2.656|||||The confidence interval for the EBA ratio is estimated using Fieller's method.|||2.656|0.736|
71845386|NCT03678688|143204968|SUPERIORITY||EBA Ratio|1.385|||||TWO_SIDED|95.0|0.564|2.206|||||The confidence interval for the EBA ratio is estimated using Taylor's method.|||2.206|0.564|
71845387|NCT01354444|143205033|OTHER||Coefficient|1.48||||0.565|TWO_SIDED|95.0|-3.796|6.761|||Regression, Linear|||This analysis compares immediate recall before and after 6 months between the treatment and placebo group.||6.761|-3.796|0.565
71845388|NCT01354444|143205034|OTHER|||||||0.481|||||||Rank sum test|||This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.||||0.481
71845389|NCT01354444|143205034|OTHER|||||||0.0562|||||||Rank sum test|||This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.||||0.0562
71845390|NCT01354444|143205034|OTHER|||||||0.314|||||||Rank sum test|||This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.||||0.314
71845391|NCT01354444|143205034|OTHER|||||||0.438|||||||Rank sum test|||This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.||||0.438
71845392|NCT00982072|143205036|OTHER|||||||0.12|||||||Fisher Exact|||||||0.12
71845393|NCT04162210|143205041|OTHER||Stratified Hazard Ratio (HR)|1.03||||0.558|TWO_SIDED|95.0|0.72|1.47|||Log Rank|One-sided p-value from stratified log-rank test were adjusted for previous treatment with anti-CD38, ISS staging and number of prior lines of therapy.|HR was estimated using the Cox Proportional Hazards. HR stratified log-rank test were adjusted for previous treatment with anti-CD38, international staging system (ISS) staging and number of prior lines of therapy.|||1.47|0.72|0.558
71845394|NCT01478594|143205103|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.706|TWO_SIDED|95.0|0.693|1.718|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O'Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.||1.718|0.693|0.706
71845395|NCT01478594|143205105|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.116||||0.754|TWO_SIDED|95.0|0.561|2.218|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||2.218|0.561|0.754
71845396|NCT01478594|143205106|SUPERIORITY_OR_OTHER|||||||0.718|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).||||||0.718
71845397|NCT01478594|143205107|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.389||||0.437|TWO_SIDED|95.0|0.604|3.194|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||3.194|0.604|0.437
71845398|NCT01478594|143205108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.006||||0.967|TWO_SIDED|95.0|0.746|1.358|||Log Rank|Stratification factors were LDH status (\< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR \< 1 indicates a reduction in the HR in favor of tivozanib.|||1.358|0.746|0.967
71845399|NCT01478594|143205111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.331|||||TWO_SIDED|95.0|0.746|2.375|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.375|0.746|
71845400|NCT01478594|143205111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.575|||||TWO_SIDED|95.0|0.285|1.16|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.160|0.285|
71783502|NCT00618072|143065738|SUPERIORITY_OR_OTHER|||||||0.032|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.032
71783503|NCT00618072|143065739|SUPERIORITY_OR_OTHER|||||||0.142|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.142
71783504|NCT00618072|143065739|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
71783505|NCT00618072|143065739|SUPERIORITY_OR_OTHER|||||||0.013|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.013
71783506|NCT00618072|143065740|SUPERIORITY_OR_OTHER|||||||0.052|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.052
71783507|NCT00618072|143065740|SUPERIORITY_OR_OTHER|||||||0.143|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.143
71783508|NCT00618072|143065740|SUPERIORITY_OR_OTHER|||||||0.005|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.005
71783509|NCT00618072|143065741|SUPERIORITY_OR_OTHER|||||||0.265|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.265
71783510|NCT00618072|143065741|SUPERIORITY_OR_OTHER|||||||0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.001
71783511|NCT00618072|143065741|SUPERIORITY_OR_OTHER|||||||0.389|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.389
71783512|NCT00618072|143065742|SUPERIORITY_OR_OTHER|||||||0.025|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.025
71783513|NCT00618072|143065742|SUPERIORITY_OR_OTHER|||||||0.162|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.162
71783514|NCT00618072|143065742|SUPERIORITY_OR_OTHER|||||||0.562|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.562
71783515|NCT00618072|143065743|SUPERIORITY_OR_OTHER|||||||0.016|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.016
71783516|NCT00618072|143065743|SUPERIORITY_OR_OTHER|||||||0.03|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.03
71783517|NCT00618072|143065743|SUPERIORITY_OR_OTHER|||||||0.15|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.150
71783518|NCT00618072|143065744|SUPERIORITY_OR_OTHER|||||||0.648|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.648
71783519|NCT00618072|143065744|SUPERIORITY_OR_OTHER|||||||0.094|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.094
71783520|NCT00618072|143065744|SUPERIORITY_OR_OTHER|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.054
71783521|NCT00618072|143065745|SUPERIORITY_OR_OTHER|||||||0.092|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.092
71783522|NCT00618072|143065745|SUPERIORITY_OR_OTHER|||||||0.73|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||0.730
71783523|NCT00618072|143065745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.||||<0.001
71783524|NCT03292588|143065746|SUPERIORITY|Negative binomial model for the rate of exacerbations in the first year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.73||||0.027|TWO_SIDED|95.0|0.56|0.96|||Regression, Negative Binomial|Adjusted relative rate of exacerbations in the first year.||||0.96|0.56|0.027
71783525|NCT03292588|143065747|SUPERIORITY||Least Square Mean Difference|-0.28||||0.29|TWO_SIDED|95.0|-0.81|0.24|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 12.||Week 12||0.24|-0.81|0.290
71783526|NCT03292588|143065747|SUPERIORITY||Least Square Mean Difference|-0.07||||0.82|TWO_SIDED|95.0|-0.69|0.55|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 24.||Week 24||0.55|-0.69|0.820
71668904|NCT01998841|142854258|SUPERIORITY||Difference in Annualized Rate of Change|0.33|STANDARD_ERROR_OF_MEAN|0.41||0.43|TWO_SIDED|95.0|-0.48|1.13|||RCRM|||Analysis was based on random coefficient regression model (RCRM) using unstructured covariance matrix: API Composite Endpoint=Treatment \* Analysis Year + interactive voice or Web-based response system (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein E4 (APOE4) Carrier Status + IxRS defined CDR Global Score.||1.13|-0.48|0.43
71751640|NCT00141453|143006438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.79||95.0|0.75|1.24|||Regression, Cox|The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline \& regions (Japan/Hong Kong) for the renal composite event rate.||We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.||1.24|0.75|0.79
71751641|NCT00141453|143006439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.039||95.0|0.43|0.98|||Regression, Cox|Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.||||0.98|0.43|0.039
71751642|NCT03585660|143006459|SUPERIORITY|||||||0.02|||||||bootstrap z-test|The standard error of the difference in accuracy was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the accuracy of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the accuracy of HM-MRI is greater than the accuracy of mp-MRI.||||0.02
71751643|NCT03585660|143006460|SUPERIORITY|||||||0.08|||||||bootstrap z-test|The standard error of the difference of AUCs was estimated using nonparametric bootstrap, with B=9999 resamples.||The null hypothesis is that the AUCs of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the AUC of HM-MRI is greater than the AUC of mp-MRI.||||0.08
71751644|NCT03585660|143006461|SUPERIORITY|||||||0.97|||||||bootstrap z-test|||The null hypothesis is that the sensitivity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the sensitivity of HM-MRI is greater than the sensitivity of mp-MRI.||||0.97
71751645|NCT03585660|143006462|SUPERIORITY||||||<|0.01|||||||bootstrap z-test|||The null hypothesis is that the specificity of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the specificity of HM-MRI is greater than the specificity of mp-MRI.||||<0.01
71751646|NCT03585660|143006463|SUPERIORITY|The null hypothesis is that the PPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the PPV of HM-MRI is greater than the PPV of mp-MRI.||||||0.06|||||||bootstrap z-test|||||||0.06
71751647|NCT03585660|143006464|SUPERIORITY|The null hypothesis is that the NPV of HM-MRI and mp-MRI are the same and the alternative hypothesis is that the NPV of HM-MRI is greater than the NPV of mp-MRI.||||||0.97|||||||bootstrap z-test|||||||0.97
71751648|NCT03137654|143006582|SUPERIORITY|||||||0.0078|||||||Linear Mixed Model|||||||.0078
71751649|NCT03137654|143006586|SUPERIORITY|||||||0.393|||||||ANOVA|||||||0.393
71751650|NCT03137654|143006588|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
71751651|NCT03137654|143006589|SUPERIORITY|||||||0.0344|||||||ANOVA|||||||.0344
71751652|NCT03137654|143006590|SUPERIORITY|||||||0.0365|||||||ANOVA|||||||0.0365
71751653|NCT03137654|143006591|SUPERIORITY|||||||0.212|||||||ANOVA|||||||.212
71751654|NCT03137654|143006592|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71751655|NCT03137654|143006593|SUPERIORITY|||||||0.445|||||||ANOVA|||||||.445
71751656|NCT03137654|143006594|SUPERIORITY|||||||0.245|||||||ANOVA|||||||.245
71751657|NCT04890652|143006595|OTHER|single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
71751658|NCT04890652|143006596|OTHER|Single group. The power-related information was estimated by calculating the effect size, specifically partial eta squared.|||||<|0.001|||||||General Linear Model|||||||<0.001
71751659|NCT03748823|143006605|NON_INFERIORITY|Noninferiority was determined based on the 90% Confidence interval calculated from the combination z-score that accounts for the interim analysis.|Ratio of Geometric Least Squares Mean|1.257|||<|0.0001|TWO_SIDED|90.0|1.16|1.361||Analysis of variance (ANOVA) was performed on log-transformed Ctrough and included treatment and stratified weight group as fixed effects.|ANOVA||Geometric least squares mean are the least squares mean from the mixed model after back transformation to the original scale. The 90% confidence interval is presented after back transformation to the original scale.|||1.361|1.160|<0.0001
71751660|NCT01069484|143006647|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of \<0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.|Risk Ratio (RR)|0.89||||0.57|TWO_SIDED|95.0|0.6|1.32||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.32|0.60|0.57
71751661|NCT01069484|143006648|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.51|TWO_SIDED|95.0|0.49|1.42||P-values \< 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|"Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of last observation carried forward was used."||1.42|0.49|0.51
71751662|NCT00771914|143006678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from baseline compared to four hours after placebo.||||0.00
71751663|NCT00771914|143006678|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.0||||0.31|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Aspirin compared to Placebo.||||0.31
71836034|NCT03526861|143177414|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.5|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.5|<0.001
71836035|NCT03526861|143177414|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-9.4|||<|0.001|TWO_SIDED|95.0|-13.6|-5.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-5.3|-13.6|<0.001
71836036|NCT03526861|143177415|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|11.5||||0.002|TWO_SIDED|95.0|4.5|18.4||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||18.4|4.5|0.002
71751664|NCT00771914|143006678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.49|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Lovaza compared to Placebo.||||0.49
71751665|NCT00771914|143006678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0||||0.03|TWO_SIDED|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from both Aspirin and Lovaza compared to Placebo.||||0.03
71783527|NCT03292588|143065747|SUPERIORITY||Least Square Mean Difference|-0.51||||0.096|TWO_SIDED|95.0|-1.11|0.09|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 36.||Week 36||0.09|-1.11|0.096
71783528|NCT03292588|143065747|SUPERIORITY||Least Square Mean Difference|-0.06||||0.831|TWO_SIDED|95.0|-0.65|0.52|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 48.||Week 48||0.52|-0.65|0.831
71783529|NCT03292588|143065747|SUPERIORITY||Least Square Mean Difference|0.02||||0.947|TWO_SIDED|95.0|-0.6|0.64|||Mixed Models Analysis|The difference in least square mean of CASI scores for week 52.||Week 52||0.64|-0.60|0.947
71783530|NCT03292588|143065748|SUPERIORITY|A generalized logit model was used to analyze Physician Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as primary exposure but was also adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|1.01||||0.974|TWO_SIDED|95.0|0.62|1.64|||Regression, Logistic|||Physician Global Assessment Tool||1.64|0.62|0.974
71836037|NCT03526861|143177415|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|7.8|23.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 75% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||23.3|7.8|<0.001
71783531|NCT03292588|143065749|SUPERIORITY|A generalized logit model was used to analyze the Patient Global Assessment Tool at Visit 14. The model included treatment arm as fixed effect as the primary exposure but was adjusted for study site, # of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils ((\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age) \& total serum IgE (\< or ≥540 kUA/L). No imputation of missing data was used for participants who weren't assessed for quality of life measurements at Visit 14.|Odds Ratio (OR)|0.72||||0.238|TWO_SIDED|95.0|0.42|1.24|||Regression, Logistic|||Patient Global Assessment Tool||1.24|0.42|0.238
71783532|NCT03292588|143065750|SUPERIORITY|A generalized mixed model as described in section 8.3.1 was used to analyze each spirometry and impulse oscillometry parameter, separately, at each visit where the lung function was collected.|Least Square Mean Difference|-0.005||||0.591|TWO_SIDED|95.0|-0.023|0.013|||Mixed Models Analysis|||FEV1/FVC Week 12||0.013|-0.023|0.591
71783533|NCT03292588|143065750|SUPERIORITY||Least Square Mean Difference|-0.011||||0.265|TWO_SIDED|95.0|-0.031|0.008|||Mixed Models Analysis|||FEV1/FVC Week 24||0.008|-0.031|0.265
71783534|NCT03292588|143065750|SUPERIORITY||Least Square Mean Difference|0.011||||0.345|TWO_SIDED|95.0|-0.012|0.033|||Mixed Models Analysis|||FEV1/FVC Week 36||0.033|-0.012|0.345
71783535|NCT03292588|143065750|SUPERIORITY||Least Square Mean Difference|0.013||||0.248|TWO_SIDED|95.0|-0.009|0.036|||Mixed Models Analysis|||FEV1/FVC Week 48||0.036|-0.009|0.248
71751666|NCT03111875|143006698|SUPERIORITY|common effect|Risk Ratio (RR)|1.04||||0.69|TWO_SIDED|95.6|0.87|1.24|||Mixed Models Analysis|||||1.24|0.87|0.69
71751667|NCT03111875|143006698|SUPERIORITY|average relative effect|Risk Ratio (RR)|0.68||||0.1|TWO_SIDED|95.6|0.43|1.08|||Mixed Models Analysis|||||1.08|0.43|0.10
71783536|NCT03292588|143065750|SUPERIORITY||Least Square Mean Difference|-0.002||||0.864|TWO_SIDED|95.0|-0.023|0.02|||Mixed Models Analysis|||FEV1/FVC Week 52||0.020|-0.023|0.864
71668905|NCT01998841|142854259|SUPERIORITY||Difference in Annualized Rate of Change|0.008|STANDARD_ERROR_OF_MEAN|0.006||0.16|TWO_SIDED|95.0|-0.003|0.02|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FCSRT Cueing Index = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.02|-0.003|0.16
71668906|NCT01998841|142854260|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.48|TWO_SIDED|95.0|0.41|1.52|||Stratified Log Rank||Hazard ratios were estimated by Cox regression|Stratification factors used: Age Group, Education History, APOE4 Carrier Status, Clinical Dementia Rating (CDR) Global Score.||1.52|0.41|0.48
71751668|NCT03111875|143006699|SUPERIORITY||Risk Ratio (RR)|1.13||||0.25|TWO_SIDED|98.75|0.87|1.47|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk).||||1.47|0.87|0.25
71751669|NCT03111875|143006700|SUPERIORITY||Risk Ratio (RR)|1.07||||0.41|TWO_SIDED|98.75|0.87|1.33|||log-binomial models|The relative risk was estimated using a GEE model to adjust for within-patient correlation across components and log link (to estimate relative risk)||||1.33|0.87|0.41
71751670|NCT00960375|143006738|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||ANOVA|||Smoking reduction outcomes were examined in the randomized sample using data from baseline and post-treatment assessments. The variable examined was self-reported number of cigarettes smoked per day during the last 7 days. This variable was skewed so a natural log transformation was applied before linear mixed model analysis.||||0.489
71751671|NCT00960375|143006739|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED||||||ANOVA|||This outcome was examined in the randomized sample. Abstinence was defined as self-reported no smoking in the last 7 days + expired CO ≤ 10 PPM. To assess difference in change between conditions, we tested the significance of the condition-by-time interaction using repeated measured mixed models with a random participant effect. Time was binary: post-treatment versus baseline. We used a logistic model for binary outcomes.||||0.685
71751672|NCT00591006|143006740|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<0.01
71751673|NCT00591006|143006740|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||.12
71751674|NCT00591006|143006740|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||.15
71751675|NCT00591006|143006740|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||.10
71751676|NCT00591006|143006741|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
71751677|NCT00591006|143006741|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
71751678|NCT00591006|143006741|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
71751679|NCT00591006|143006741|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||.02
71751680|NCT00591006|143006742|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||||||.08
71751681|NCT00591006|143006742|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||||||<.01
71751682|NCT00591006|143006742|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||.11
71751683|NCT00591006|143006742|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|||||||.06
71751684|NCT03174184|143006755|EQUIVALENCE|Equivalence tests will be conducted to examine whether the EBA0-14CFU of Arm A is different from the EBA0-14CFU of Arm B. A similar comparison will be done comparing Arm C to Arm D, Arm A to Arm C, Arm D to Arm E, Arm D to Arm F, and Arm E to Arm F.|||||<|0.001|||||||Regression, Linear|||||||<0.001
71751685|NCT00525512|143006764|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.1062||95.0|0.97|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|0.97|0.1062
71751686|NCT00525512|143006765|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.008||95.0|1.03|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.23|1.03|0.008
71751687|NCT00525512|143006766|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.1||||0.0597||95.0|1.0|1.21||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.21|1.00|0.0597
71751688|NCT00525512|143006767|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.15||||0.0131||95.0|1.03|1.29||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.29|1.03|0.0131
71751689|NCT00525512|143006768|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.18||||0.0041||95.0|1.05|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.32|1.05|0.0041
71751690|NCT00525512|143006769|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.11||||0.0945||95.0|0.98|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|0.98|0.0945
71751691|NCT00525512|143006770|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.12||||0.0899||95.0|0.98|1.28||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.28|0.98|0.0899
71751692|NCT00525512|143006771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|||<|0.0001||95.0|0.073|0.16||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.160|0.073|<0.0001
71751693|NCT00525512|143006772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082||||0.0005||95.0|0.036|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.036|0.0005
71751694|NCT00525512|143006773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.0003||95.0|0.041|0.137||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.137|0.041|0.0003
71751695|NCT00525512|143006774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|||<|0.0001||95.0|0.058|0.153||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.153|0.058|<0.0001
71751696|NCT00525512|143006775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0005||95.0|0.04|0.141||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.141|0.040|0.0005
71751697|NCT00525512|143006776|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.094||||0.0002||95.0|0.045|0.144||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.144|0.045|0.0002
71751698|NCT00525512|143006777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.0059||95.0|0.022|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.128|0.022|0.0059
71751699|NCT00525512|143006778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.11|0.198||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.198|0.110|<0.0001
71783537|NCT03292588|143065751|SUPERIORITY||Least Square Mean Difference|-0.4||||0.816|TWO_SIDED|95.0|-3.8|3.0|||Mixed Models Analysis|||FEV1PP Week 12||3.0|-3.8|0.816
71891720|NCT01075178|143304868|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.81|||||ONE_SIDED|95.0||0.96|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.96||
71751700|NCT00525512|143006779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.117|0.208||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.208|0.117|<0.0001
71751701|NCT00525512|143006780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.099|0.192||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.192|0.099|<0.0001
71751702|NCT00525512|143006781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|||<|0.0001||95.0|0.077|0.176||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.176|0.077|<0.0001
71751703|NCT00525512|143006782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.0001||95.0|0.083|0.185||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.185|0.083|<0.0001
71751704|NCT00525512|143006783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|||<|0.0001||95.0|0.097|0.202||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.202|0.097|<0.0001
71751705|NCT00525512|143006784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.0001||95.0|0.077|0.183||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.183|0.077|<0.0001
71751706|NCT00525512|143006785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|||<|0.0001||95.0|0.127|0.307||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.307|0.127|<0.0001
71751707|NCT00525512|143006786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.0019||95.0|0.058|0.255||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.255|0.058|0.0019
71783538|NCT03292588|143065751|SUPERIORITY||Least Square Mean Difference|-3.4||||0.095|TWO_SIDED|95.0|-7.4|0.6|||Mixed Models Analysis|||FEV1PP Week 24||0.6|-7.4|0.095
71783539|NCT03292588|143065751|SUPERIORITY||Least Square Mean Difference|1.5||||0.444|TWO_SIDED|95.0|-2.4|5.5|||Mixed Models Analysis|||FEV1PP Week 36||5.5|-2.4|0.444
71783540|NCT03292588|143065751|SUPERIORITY||Least Square Mean Difference|0.6||||0.751|TWO_SIDED|95.0|-3.3|4.6|||Mixed Models Analysis|||FEV1PP Week 48||4.6|-3.3|0.751
71751708|NCT00525512|143006787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.0006||95.0|0.078|0.286||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.286|0.078|0.0006
71751709|NCT00525512|143006788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|||<|0.0001||95.0|0.13|0.339||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.339|0.130|<0.0001
71751710|NCT00525512|143006789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161||||0.009||95.0|0.04|0.281||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.281|0.040|0.009
71896215|NCT01709799|143314376|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,99.647)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
71896216|NCT01709799|143314376|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,99.601)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.781
71751711|NCT00525512|143006790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212||||0.0002||95.0|0.102|0.322||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.322|0.102|0.0002
71751712|NCT00525512|143006791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||<|0.0001||95.0|0.128|0.355||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.355|0.128|<0.0001
71751713|NCT00525512|143006792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.277|||<|0.0001||95.0|0.179|0.375||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.375|0.179|<0.0001
71751714|NCT00525512|143006793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||<|0.0001||95.0|0.226|0.425||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.425|0.226|<0.0001
71751715|NCT00525512|143006794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|||<|0.0001||95.0|0.245|0.461||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.461|0.245|<0.0001
71751716|NCT00525512|143006795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.259|||<|0.0001||95.0|0.154|0.365||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.365|0.154|<0.0001
71783541|NCT03292588|143065751|SUPERIORITY||Least Square Mean Difference|-2.6||||0.184|TWO_SIDED|95.0|-6.5|1.3|||Mixed Models Analysis|||FEV1PP Week 52||1.3|-6.5|0.184
71813103|NCT03720938|143128559|SUPERIORITY|||||||0.0001402||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.||||0.0001402
71813104|NCT03720938|143128559|SUPERIORITY|||||||0.000235||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body index z score.||||0.000235
71668907|NCT01998841|142854261|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.76|TWO_SIDED|95.0|0.53|1.59|||Stratified Log Rank||Hazard ratios were estimated by Cox regression.|Stratification factors used: Age Group, Education History, APOE4 Carrier Status.||1.59|0.53|0.76
71668908|NCT01998841|142854262|SUPERIORITY||Difference in Annualized Rate of Change|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.64|TWO_SIDED|95.0|-0.15|0.09|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: CDR-SB = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.09|-0.15|0.64
71668909|NCT01998841|142854263|SUPERIORITY||Difference in Annualized Rate of Change|0.18|STANDARD_ERROR_OF_MEAN|0.29||0.55|TWO_SIDED|95.0|-0.4|0.75|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: RBANS Total Score = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.75|-0.40|0.55
71668910|NCT01998841|142854264|SUPERIORITY||Difference in Annualized Rate of Change|-0.0006|STANDARD_ERROR_OF_MEAN|0.002||0.69|TWO_SIDED|95.0|-0.0037|0.0024|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: PET SUVR = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.0024|-0.0037|0.69
71668911|NCT01998841|142854265|SUPERIORITY||Difference in Annualized Rate of Change|0.003|STANDARD_ERROR_OF_MEAN|0.002||0.25|TWO_SIDED|95.0|-0.002|0.007|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: FDG-PET = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.007|-0.002|0.25
71668912|NCT01998841|142854266|SUPERIORITY||Difference in Annualized Rate of Change|107.78|STANDARD_ERROR_OF_MEAN|92.28||0.25|TWO_SIDED|95.0|-74.5|290.05|||RCRM|||Whole Brain: Analysis was based on RCRM using unstructured covariance matrix: MRI Whole Brain (Derived) = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||290.05|-74.5|0.25
71668913|NCT01998841|142854266|SUPERIORITY||Difference in Annualized Rate of Change|9.6|STANDARD_ERROR_OF_MEAN|17.39||0.58|TWO_SIDED|95.0|-24.74|43.94|||RCRM|||Bilateral Hippocampus: Analysis was based on RCRM using unstructured covariance matrix: MRI Bilateral Hippocampus = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||43.94|-24.74|0.58
71668914|NCT01998841|142854266|SUPERIORITY||Difference in Annualized Rate of Change|19.92|STANDARD_ERROR_OF_MEAN|213.08||0.93|TWO_SIDED|95.0|-400.78|440.62|||RCRM|||Ventricles: Analysis was based on RCRM using unstructured covariance matrix: MRI Ventricles = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||440.62|-400.78|0.93
71668915|NCT01998841|142854267|SUPERIORITY||Difference in Annualized Rate of Change|-1.97|STANDARD_ERROR_OF_MEAN|3.09||0.53|TWO_SIDED|95.0|-8.17|4.23|||RCRM|||tTau: Analysis was based on RCRM using unstructured covariance matrix: CSF tTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||4.23|-8.17|0.53
71783542|NCT03292588|143065752|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.85||||0.458|TWO_SIDED|95.0|0.55|1.31|||Mixed Models Analysis|||Did not meet FDA-approved dosing||1.31|0.55|0.458
71783543|NCT03292588|143065753|SUPERIORITY|Negative binomial model for the rate of exacerbations (per year. The model included an offset term to account for differential follow-up among participants. To account for adaptive randomization, the model was also adjusted for study site, number of exacerbations in year prior to study (2 or 3+), peripheral blood eosinophils (\< or ≥400 cells/μl), BMI (\< or ≥95th percentile for age), total serum IgE (\< or ≥540 kUA/L) and treatment dose (40 mg or 100 mg).|Risk Ratio (RR)|0.67||||0.025|TWO_SIDED|95.0|0.47|0.95|||Regression, Negative Binomial|||Fit FDA-approved dosing||0.95|0.47|0.025
71783544|NCT03292588|143065754|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3587|TWO_SIDED|95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3587
71896217|NCT01709799|143314377|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,102.315)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
71896218|NCT01709799|143314377|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,102.216)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.026
71751717|NCT00525512|143006796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||<|0.0001||95.0|0.194|0.406||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.406|0.194|<0.0001
71751718|NCT00525512|143006797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|||<|0.0001||95.0|0.144|0.364||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.364|0.144|<0.0001
71751719|NCT00525512|143006798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||<|0.0001||95.0|0.209|0.456||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.456|0.209|<0.0001
71751720|NCT00525512|143006799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.1131||95.0|-0.72|0.08||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.08|-0.72|0.1131
71751721|NCT00525512|143006800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9071||95.0|-0.38|0.33||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.33|-0.38|0.9071
71751722|NCT00525512|143006801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.6878||95.0|-0.35|0.53||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||0.53|-0.35|0.6878
71751723|NCT00525512|143006802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||||95.0|-2.39|3.11||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.11|-2.39|
71751724|NCT00525512|143006803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||||95.0|-2.66|3.31||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.31|-2.66|
71751725|NCT00525512|143006804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||||95.0|-2.91|3.58||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.58|-2.91|
71751726|NCT00525512|143006805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-2.97|3.43||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.43|-2.97|
71751727|NCT00525512|143006806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||||95.0|-3.02|3.46||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.46|-3.02|
71751728|NCT00525512|143006807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||||95.0|-3.1|3.41||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.41|-3.10|
71751729|NCT00525512|143006808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||||95.0|-3.22|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.22|
71751730|NCT00525512|143006809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||||95.0|-2.78|3.52||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.52|-2.78|
71751731|NCT00525512|143006810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||||95.0|-3.05|3.51||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.51|-3.05|
71751732|NCT00525512|143006811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||||95.0|-3.4|3.55||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.55|-3.40|
71751733|NCT00525512|143006812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||||95.0|-3.61|3.92||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.92|-3.61|
71783545|NCT00592384|143065768|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary comparisons|Mixed Models Analysis|see above||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
71783546|NCT00592384|143065781|SUPERIORITY_OR_OTHER||||||<|0.025||||||Bonferroni corrected for two primary outcomes|Mixed Models Analysis|||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants' intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.||||<.025
71751734|NCT00525512|143006813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.53|3.9||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.90|-3.53|
71751735|NCT00525512|143006814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||||95.0|-3.36|3.71||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.71|-3.36|
71751736|NCT00525512|143006815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||||95.0|-3.82|3.96||Based on a MMRM analysis with terms for treatment, centre and baseline.||||||3.96|-3.82|
71751737|NCT00525512|143006816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03||||0.0072||95.0|-6.97|-1.1||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-1.10|-6.97|0.0072
71751738|NCT00525512|143006817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.2029||95.0|-5.91|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||1.26|-5.91|0.2029
71751739|NCT00525512|143006818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.58||||0.0313||95.0|-6.84|-0.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-0.32|-6.84|0.0313
71751740|NCT00525512|143006819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.94||||0.0001||95.0|-13.37|-4.52||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis|||||-4.52|-13.37|0.0001
71751741|NCT00525512|143006820|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.6541||95.0|0.719|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Regression, Cox|||||1.230|0.719|0.6541
71751742|NCT00525512|143006821|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.06||||0.4443||95.0|0.91|1.25||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||1.25|0.91|0.4443
71751743|NCT00525512|143006822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.8644||95.0|-0.05|0.06||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.06|-0.05|0.8644
71751744|NCT00525512|143006823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.4277||95.0|-0.07|0.17||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.17|-0.07|0.4277
71751745|NCT00525512|143006824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.7071||95.0|-3.81|2.59||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||2.59|-3.81|0.7071
71751746|NCT00525512|143006825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.6556||95.0|-3.03|4.81||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||4.81|-3.03|0.6556
71751747|NCT00525512|143006826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.9896||95.0|-3.44|3.48||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||3.48|-3.44|0.9896
71751748|NCT00525512|143006827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.0807||95.0|-9.19|0.53||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA|||||0.53|-9.19|0.0807
71891721|NCT01075178|143304869|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.8|||||ONE_SIDED|95.0||0.95|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||0.95||
71891722|NCT01075178|143304870|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|1.05|||||ONE_SIDED|95.0||1.64|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||1.64||
71891723|NCT01075178|143304871|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.9|||||ONE_SIDED|95.0||2.19|||exact binomial||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.||2.19||
71891724|NCT00826514|143304935|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|95.0|-1.15|0.209||||||Analysis was based on analysis of co-variance (ANCOVA) model with baseline value, age and treatment as covariates.||0.209|-1.150|
71751749|NCT00402168|143006840|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.||14.9|2.1|
71751750|NCT00402168|143006840|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|95.0|2.1|14.9||||||At Month 12, difference in percentage of participants with acute rejection using exact method.||14.9|2.1|
71751751|NCT00402168|143006841|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.||6.1|-3.3|
71751752|NCT00402168|143006841|SUPERIORITY_OR_OTHER||Percent Difference|1.1|||||TWO_SIDED|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.||6.1|-3.3|
71751753|NCT00402168|143006844|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-0.1|13.8||||||||13.8|-0.1|
71751754|NCT00402168|143006849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.4491|TWO_SIDED|95.0|-1.7|3.9|||ANCOVA|||Mental Component Scales (MCS)||3.9|-1.7|0.4491
71751755|NCT00402168|143006849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.7892|TWO_SIDED|95.0|-2.5|1.9|||ANCOVA|||Physical Component Scales (PCS)||1.9|-2.5|0.7892
71751756|NCT00402168|143006851|SUPERIORITY_OR_OTHER||Estimated Difference|0.0076|||||TWO_SIDED|95.0|-0.01|0.0252||||||Difference in Symptom Occurrence between treatment groups.||.0252|-.010|
71751757|NCT00402168|143006851|SUPERIORITY_OR_OTHER||Estimated Difference|0.0148|||||TWO_SIDED|95.0|-0.002|0.0321||||||Difference in Symptom Distress between treatment groups.||.0321|-.002|
71751758|NCT00301808|143006871|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier product limit|0.66|STANDARD_ERROR_OF_MEAN|0.1423|||TWO_SIDED|95.0|0.48|0.84||||||||0.84|0.48|
71751759|NCT05893862|143006883|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|9.22|||<|0.0001|TWO_SIDED|90.0|7.4|11.04|||t-test, 1 sided|||||11.04|7.40|<0.0001
71751760|NCT05893862|143006883|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|8.44||||0.0141|TWO_SIDED|90.0|6.31|10.56|||t-test, 1 sided|||||10.56|6.31|0.0141
71751761|NCT05893862|143006883|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|10.8|||<|0.0001|TWO_SIDED|90.0|8.85|12.74|||t-test, 1 sided|||||12.74|8.85|<0.0001
71751762|NCT05893862|143006883|OTHER|LS Mean Difference Week 4 Hr|LS Mean Difference|6.43||||0.1045|TWO_SIDED|90.0|3.96|8.91|||t-test, 1 sided|||||8.91|3.96|0.1045
71751763|NCT05893862|143006883|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|6.52|||||TWO_SIDED|90.0|4.66|8.38||||||||8.38|4.66|
71751764|NCT05893862|143006883|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|7.33||||||90.0|4.74|9.93||||||||9.93|4.74|
71751765|NCT05893862|143006883|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|6.42|||||TWO_SIDED|90.0|3.95|8.88||||||||8.88|3.95|
71751766|NCT05893862|143006883|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|2.79|||||TWO_SIDED|90.0|0.81|4.76||||||||4.76|0.81|
71751767|NCT05893862|143006886|OTHER|LS Mean Difference 0.5 Hr|LS Mean Difference|0.52|||||TWO_SIDED|90.0|-1.11|2.14||||||||2.14|-1.11|
71751768|NCT05893862|143006886|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|0.36|||||TWO_SIDED|90.0|-1.26|1.98||||||||1.98|-1.26|
71751769|NCT05893862|143006886|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|1.31|||||TWO_SIDED|90.0|-1.04|3.66||||||||3.66|-1.04|
71751770|NCT05893862|143006886|OTHER|LS Mean Difference 3 hr|LS Mean Difference|4.27|||||TWO_SIDED|90.0|1.9|6.64||||||||6.64|1.90|
71751771|NCT05893862|143006886|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|7.0|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
71751772|NCT05893862|143006886|OTHER|LS Mean Difference 6 Hr|LS Mean Difference|7.85|||||TWO_SIDED|90.0|4.35|9.64||||||||9.64|4.35|
71751773|NCT05893862|143006886|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|9.25|||||TWO_SIDED|90.0|6.71|11.8||||||||11.80|6.71|
71668916|NCT01998841|142854267|SUPERIORITY||Difference in Annualized Rate of Change|-0.5|STANDARD_ERROR_OF_MEAN|0.46||0.28|TWO_SIDED|95.0|-1.43|0.43|||RCRM|||pTau: Analysis was based on RCRM using unstructured covariance matrix: CSF pTau = Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||0.43|-1.43|0.28
71751774|NCT05893862|143006886|OTHER|LS Mean Difference 12 Hr|LS Mean Difference|4.81|||||TWO_SIDED|90.0|2.27|7.35||||||||7.35|2.27|
71751775|NCT05893862|143006886|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|3.57|||||TWO_SIDED|90.0|0.91|6.23||||||||6.23|0.91|
71751776|NCT05893862|143006886|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|5.01|||||TWO_SIDED|90.0|3.18|6.85||||||||6.85|3.18|
71751777|NCT05893862|143006886|OTHER|LS Mean Difference 1 Hr|LS Mean Difference|3.95|||||TWO_SIDED|90.0|1.56|6.34||||||||6.34|1.56|
71783547|NCT00869349|143065787|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||0.0|-1.1|0.04
71783548|NCT00869349|143065788|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.01|TWO_SIDED|95.0|-5.6|-0.8||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||-0.8|-5.6|0.01
71783549|NCT00869349|143065789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.01|TWO_SIDED|95.0|0.5|3.1||a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.||3.1|0.5|0.01
71783550|NCT03633695|143065790|SUPERIORITY||Mean Difference (Final Values)|-0.177|||<|0.0001|TWO_SIDED|95.0|-0.214|-0.14||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.140|-0.214|<.0001
71783551|NCT03633695|143065791|SUPERIORITY||Mean Difference (Final Values)|-0.191|||<|0.0001|TWO_SIDED|95.0|-0.223|-0.158||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 Group was greater (i.e. worse) than or equal to that for the Control Group. The alternative hypothesis was that the mean for the IC-8 Group less (i.e., better) than that for the Control Group.||-0.158|-0.223|<.0001
71783552|NCT03633695|143065792|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|-0.012|||<|0.0001|ONE_SIDED|95.0||0.007||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Group - Control Group|The null hypothesis was that the mean acuity for the IC-8 IOL Group is inferior to the Control Group by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 IOL group is inferior to the Control Group by less than 0.1 logMAR.||0.007||<.0001
71783553|NCT03633695|143065793|SUPERIORITY||Mean Difference (Final Values)|-0.18|||<|0.0001|TWO_SIDED|95.0|-0.198|-0.163||The threshold for statistical significance was p=0.05.|t-test, 2 sided||Acuity Difference = IC-8 IOL Eye (IC-8 IOL Group) - Fellow Eye (IC-8 IOL Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes is greater (i.e., worse) than or equal to that for the fellow eyes. The alternative hypothesis was that the mean for the IC-8 IOL eyes is less (i.e., better) than that for the fellow eyes.||-0.163|-0.198|<.0001
71783554|NCT03633695|143065794|OTHER||Difference in depth of focus|0.91|||||TWO_SIDED||||||||Difference in depth of focus \[IC-8™ IOL Eyes (IC-8™ IOL Group) - Fellow Eyes (IC-8™ IOL Group)\]|||||
71845401|NCT01478594|143205112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.608|||||TWO_SIDED|95.0|0.635|4.073|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.073|0.635|
71751778|NCT05893862|143006886|OTHER|LS Mean Difference 2 Hr|LS Mean Difference|3.92|||||TWO_SIDED|90.0|1.49|6.35||||||||6.35|1.49|
71751779|NCT05893862|143006886|OTHER|LS Mean Difference 3 Hr|LS Mean Difference|4.68|||||TWO_SIDED|90.0|2.33|7.03||||||||7.03|2.33|
71751780|NCT05893862|143006886|OTHER|LS Mean Difference 4 Hr|LS Mean Difference|4.79|||||TWO_SIDED|90.0|2.45|7.12||||||||7.12|2.45|
71751781|NCT05893862|143006886|OTHER|LS Mean Difference 8 Hr|LS Mean Difference|4.82|||||TWO_SIDED|90.0|1.93|7.71||||||||7.71|1.93|
71751782|NCT05893862|143006886|OTHER|LS Mean Difference 11 Hr|LS Mean Difference|5.3|||||TWO_SIDED|90.0|2.51|8.09||||||||8.09|2.51|
71751783|NCT05893862|143006886|OTHER|LS Mean Difference 14 Hr|LS Mean Difference|5.85|||||TWO_SIDED|90.0|2.97|8.74||||||||8.74|2.97|
71751784|NCT05893862|143006886|OTHER|LS Mean Difference 16 Hr|LS Mean Difference|4.12|||||TWO_SIDED|90.0|1.79|6.45||||||||6.45|1.79|
71751785|NCT05893862|143006886|OTHER|LS Mean Difference 24 Hr|LS Mean Difference|0.78|||||TWO_SIDED|90.0|-1.69|3.26||||||||3.26|-1.69|
71751786|NCT03346434|143006906|SUPERIORITY||Percentage difference|23.8|||<|0.0001|TWO_SIDED|95.0|13.27|34.37||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||34.37|13.27|< 0.0001
71751787|NCT03346434|143006907|SUPERIORITY||Percentage difference|42.3|||<|0.0001|TWO_SIDED|95.0|29.47|55.16||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||55.16|29.47|< 0.0001
71751788|NCT03346434|143006916|SUPERIORITY||Least Square (LS) Mean Difference|-50.4|||<|0.0001|TWO_SIDED|95.0|-62.38|-38.4||Threshold for significance at 0.05 level.|ANCOVA|||||-38.40|-62.38|< 0.0001
71751789|NCT03346434|143006917|SUPERIORITY||LS Mean Difference|-47.1|||<|0.0001|TWO_SIDED|95.0|-59.47|-34.79||Threshold for significance at 0.05 level.|ANCOVA|||||-34.79|-59.47|< 0.0001
71751790|NCT03346434|143006918|SUPERIORITY||Percentage difference|39.2|||<|0.0001|TWO_SIDED|95.0|26.18|52.27||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||52.27|26.18|< 0.0001
71751791|NCT03346434|143006919|SUPERIORITY||Percentage difference|43.3|||<|0.0001|TWO_SIDED|95.0|30.03|56.67||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||56.67|30.03|< 0.0001
71891725|NCT00826514|143304938|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.42|STANDARD_ERROR_OF_MEAN|1.901|||TWO_SIDED|90.0|-4.754|1.905||||||Change at Week 6, CPSI Total Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.905|-4.754|
71891726|NCT00826514|143304938|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.931|||TWO_SIDED|90.0|-2.701|0.591||||||Change at Week 6, CPSI PD Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.591|-2.701|
71751792|NCT03346434|143006920|SUPERIORITY||Percentage difference|48.5|||<|0.0001|TWO_SIDED|95.0|35.03|62.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||62.00|35.03|< 0.0001
71751793|NCT03346434|143006921|SUPERIORITY||Percentage difference|22.5|||=|0.0001|TWO_SIDED|95.0|12.37|32.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||32.60|12.37|= 0.0001
71751794|NCT03346434|143006922|SUPERIORITY||LS Mean Difference|-24.27|||<|0.0001|TWO_SIDED|95.0|-31.204|-17.329||Threshold for significance at 0.05 level.|ANCOVA|||||-17.329|-31.204|< 0.0001
71751795|NCT03346434|143006923|SUPERIORITY||LS Mean Difference|-9.1|||<|0.0001|TWO_SIDED|95.0|-11.26|-6.89||Threshold for significance at 0.05 level.|ANCOVA|||||-6.89|-11.26|< 0.0001
71751796|NCT03346434|143006924|SUPERIORITY||LS Mean Difference|-38.4|||<|0.0001|TWO_SIDED|95.0|-46.65|-30.21||Threshold for significance at 0.05 level.|ANCOVA|||||-30.21|-46.65|< 0.0001
71891727|NCT00826514|143304938|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.38|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|90.0|-0.789|1.541||||||Change at Week 6, CPSI US Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.541|-0.789|
71891728|NCT00826514|143304938|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.697|||TWO_SIDED|90.0|-1.785|0.631||||||Change at Week 6, CPSI QoL Score: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.631|-1.785|
71751797|NCT03346434|143006925|SUPERIORITY||LS Mean Difference|1.7|||<|0.0001|TWO_SIDED|95.0|1.093|2.317||Threshold significance was at 0.05 level.|ANCOVA|||||2.317|1.093|< 0.0001
71751798|NCT03346434|143006926|SUPERIORITY||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.029|-2.6||Threshold significance at 0.05 level.|ANCOVA|||||-2.600|-4.029|< 0.0001
71751799|NCT03346434|143006927|SUPERIORITY||LS Mean Difference|-7.8|||<|0.0001|TWO_SIDED|95.0|-9.789|-5.814||Threshold significance at 0.05 level.|ANCOVA|||||-5.814|-9.789|< 0.0001
71751800|NCT03346434|143006928|SUPERIORITY||LS Mean Difference|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.29|-4.75||Threshold significance at 0.05 level.|ANCOVA|||||-4.75|-10.29|< 0.0001
71751801|NCT03346434|143006929|SUPERIORITY||LS Mean Difference|-8.96|||<|0.0001|TWO_SIDED|95.0|-11.711|-6.202||Threshold significance at 0.05 level.|ANCOVA|||||-6.202|-11.711|< 0.0001
71751802|NCT03346434|143006930|SUPERIORITY||||||=|0.0015||||||Threshold significance is at 0.05 level.|ANCOVA|||||||= 0.0015
71751803|NCT03346434|143006931|SUPERIORITY||LS Mean Difference|-2.9|||=|0.0997|TWO_SIDED|95.0|-6.35|0.56||Threshold significance at 0.05 level.|ANCOVA|||||0.56|-6.35|= 0.0997
71751804|NCT01183689|143006934|SUPERIORITY||Mean Difference (Net)|0.82|STANDARD_ERROR_OF_MEAN|0.3|<|0.05|TWO_SIDED|95.0|0.23|1.41||No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.|Mixed Models Analysis||Above is provided the mean difference between Arms 1 and 2.|Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.||1.41|0.23|<0.05
71751805|NCT01183689|143006934|SUPERIORITY||Mean Difference (Net)|2.64|||<|0.05|TWO_SIDED|95.0|2.05|3.22|||Mixed Models Analysis|This was fitted with Proc Mixed in SAS.|95% confidence interval excludes 0|Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.||3.22|2.05|<0.05
71751806|NCT01183689|143006935|OTHER|Generalized Estimating Equations|Odds Ratio (OR)|1.41|||<|0.05|TWO_SIDED|95.0|1.02|1.9|||Generalized Estimating Equations|||Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.||1.90|1.02|<0.05
71751807|NCT01183689|143006935|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.05|TWO_SIDED|95.0|1.64|3.19|||generalized estimating equations|||This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,||3.19|1.64|<0.05
71891729|NCT00826514|143304939|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|90.0|-0.99|1.348||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.348|-0.990|
71891730|NCT00826514|143304940|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|90.0|-1.829|1.452||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.452|-1.829|
71783555|NCT03633695|143065795|NON_INFERIORITY|The non-inferiority margin was 0.1 logMAR.|Mean Difference (Final Values)|0.068|||<|0.0001|ONE_SIDED|95.0||0.082||The threshold for statistical significance was p=0.05.|t-test, 1 sided||Acuity Difference = IC-8 IOL Eyes (IC-8 Group) - Fellow Eyes (IC-8 Group)|The null hypothesis was that the mean acuity for the IC-8 IOL eyes was inferior to the fellow eyes by 0.1 logMAR or more. The alternative hypothesis was that the mean acuity for the IC-8 eyes was inferior to the fellow eyes by less than 0.1 logMAR.||0.082||<.0001
71783556|NCT03633695|143065803|NON_INFERIORITY|Non-inferiority margin was 0.12 logMAR.|Mean Difference (Final Values)|0.023|||<|0.0001|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05.|t-test, 1 sided|||The null hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to the Astigmatism Group 1 by 0.12 logMAR or more. The alternative hypothesis was that the mean acuity in Astigmatism Group 2 was inferior to Astigmatism Group 1 by less than 0.12 logMAR.||||<.0001
71783557|NCT02728050|143065814|SUPERIORITY|||||||0.48|||||||Fisher Exact|||"Participants on study receiving CLAGM-S were compared to a historical cohort of newly diagnosed AML/high-risk MDS patients treated with CLAG-M alone, matched for mitoxantrone dose, age, and TRM score.~Number of participants in historical cohort = 71. Number of participants in historical cohort who achieved MRD-negative CR = 55 (77.46%)"||||0.48
71783558|NCT01976338|143065852|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71783559|NCT00777608|143065862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.231|TWO_SIDED|90.0|-0.2|0.08|||ANOVA|||||0.08|-0.2|0.231
71783560|NCT00777608|143065863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|90.0|-0.3|-0.008|||ANOVA||Statistical analysis for Week 2|||-0.008|-0.3|0.041
71783561|NCT00777608|143065863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.143|TWO_SIDED|90.0|-0.3|0.06|||ANOVA||Statistical analysis for Week 8|||0.06|-0.3|0.143
71783562|NCT00777608|143065863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.226|TWO_SIDED|90.0|-0.2|0.09|||ANOVA||Statistical analysis for Week 12|||0.09|-0.2|0.226
71783563|NCT00777608|143065864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.0||0.324|TWO_SIDED|90.0|-1.2|2.2|||ANOVA||Statistical analysis for Week 4|||2.2|-1.2|0.324
71783564|NCT00777608|143065864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.4||0.285|TWO_SIDED|90.0|-1.5|3.1|||ANOVA|||||3.1|-1.5|0.285
71783565|NCT00777608|143065864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.401|TWO_SIDED|90.0|-2.6|1.9|||ANOVA||Statistical analysis for Week 12|||1.9|-2.6|0.401
71783566|NCT03766581|143065873|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.87|1.1|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg QD over Placebo||1.10|0.87|
71783567|NCT03766581|143065873|SUPERIORITY||Relative Risk (RR)|0.99|||||TWO_SIDED|95.0|0.83|1.15|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 25 mg BID over Placebo||1.15|0.83|
71668917|NCT01998841|142854275|SUPERIORITY||Difference in Annualized Rate of Change|7522.55|STANDARD_ERROR_OF_MEAN|313.17|<|0.0001|TWO_SIDED|95.0|6903.44|8141.65|||RCRM|||Aβ1-40: Analysis was based on RCRM using unstructured covariance matrix: APlasma Amyloid Beta 1-40 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||8141.65|6903.44|<0.0001
71668918|NCT01998841|142854275|SUPERIORITY||Difference in Annualized Rate of Change|556.03|STANDARD_ERROR_OF_MEAN|23.98|<|0.0001|TWO_SIDED|95.0|508.63|603.44|||RCRM|||Aβ1-42: Analysis was based on RCRM using unstructured covariance matrix: Plasma Amyloid Peptid Beta 42 =Treatment \* Analysis Year + IxRS defined Age Group + IxRS defined Education History + IxRS defined APOE4 Carrier Status + IxRS defined CDR Global Score.||603.44|508.63|<0.0001
71836038|NCT03526861|143177416|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|26.2|||<|0.001|TWO_SIDED|95.0|16.1|36.3||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||36.3|16.1|<0.001
71668919|NCT01263938|142854342|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
71668920|NCT01263938|142854342|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
71668921|NCT01263938|142854342|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
71668922|NCT01263938|142854343|OTHER||||||>|0.999||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||>0.999
71668923|NCT01263938|142854344|OTHER|||||||0.813||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.813
71668924|NCT01263938|142854345|OTHER|||||||0.625||||||Threshold for statistical significance: p\<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.||||0.625
71668925|NCT02854527|142854353|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.39|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|88.22|105.33|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R1.||105.33|88.22|
71668926|NCT02854527|142854354|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|93.17|STANDARD_DEVIATION|24.1|||TWO_SIDED|90.0|83.49|103.97|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R1.||103.97|83.49|
71751808|NCT01183689|143006936|SUPERIORITY||Mean Difference (Net)|1.31|STANDARD_ERROR_OF_MEAN|0.47|<|0.05|TWO_SIDED|95.0|0.39|2.24|||Mixed Models Analysis|The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.|Listed above is the mean difference between arms 1 and 2|Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.||2.24|0.39|<0.05
71751809|NCT01183689|143006936|SUPERIORITY||Median Difference (Net)|2.04|||<|0.05|TWO_SIDED|95.0|1.11|2.98|||Mixed Models Analysis|A linear contrast was used to compare groups 1 and 3 at 24 months.||A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.||2.98|1.11|<0.05
71751810|NCT01183689|143006937|SUPERIORITY||Mean Difference (Net)|1.99||||0.13|TWO_SIDED|95.0|0.06|3.92||The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.|ANOVA|||Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.||3.92|0.06|0.13
71751811|NCT01183689|143006937|SUPERIORITY||Mean Difference (Net)|0.93||||0.13|TWO_SIDED|95.0|-0.98|2.84|||ANOVA|||Mean differences in systolic blood pressure between groups 1 and 3 over time.||2.84|-0.98|0.13
71751812|NCT01183689|143006938|SUPERIORITY||Mean Difference (Net)|1.73||||0.06|TWO_SIDED|95.0|0.32|3.14||The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.|ANOVA|||Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.||3.14|0.32|0.06
71751813|NCT01183689|143006938|SUPERIORITY||Mean Difference (Net)|0.92||||0.06|TWO_SIDED|95.0|-0.49|2.33||This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.||2.33|-0.49|0.06
71751814|NCT01183689|143006939|SUPERIORITY||Mean Difference (Net)|-1.3||||0.73|TWO_SIDED|95.0|-6.12|3.52||The p-value results from a 2 degree of freedom F-test.|ANOVA|||Mean changes from baseline to 2 years were compared between Groups 1 and 2.||3.52|-6.12|0.73
71751815|NCT01183689|143006939|SUPERIORITY||Mean Difference (Net)|-1.89||||0.73|TWO_SIDED|95.0|-4.36|0.58||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.||0.58|-4.36|0.73
71751816|NCT01183689|143006940|SUPERIORITY||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.23|4.52||The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.|generalized estimating equations|||The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.||4.52|1.23|<0.001
71751817|NCT01183689|143006940|SUPERIORITY||Odds Ratio (OR)|2.13||||0.008|TWO_SIDED|95.0|1.12|4.1||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|generalized estimating equations|||Generalized estimating equations were used. Differences were summarized with odds ratios.||4.10|1.12|0.008
71783568|NCT03766581|143065873|SUPERIORITY||Relative Risk (RR)|0.93|||||TWO_SIDED|95.0|0.76|1.16|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 50 mg BID over Placebo||1.16|0.76|
71783569|NCT03766581|143065873|SUPERIORITY||Relative Risk (RR)|0.92|||||TWO_SIDED|95.0|0.73|1.18|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 100 mg BID over Placebo||1.18|0.73|
71751818|NCT01183689|143006941|SUPERIORITY||Mean Difference (Net)|-0.08||||0.002|TWO_SIDED|95.0|-0.61|0.45||the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups|ANOVA|the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups||Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test||0.45|-0.61|0.002
71751819|NCT01183689|143006941|SUPERIORITY||Mean Difference (Net)|0.55||||0.002|TWO_SIDED|95.0|0.02|1.08||This p-value is from a 2 degree of freedom test for differences among all 3 groups|ANOVA|||Differences among the 3 groups were based on analyses of variance.||1.08|0.02|0.002
71751820|NCT01183689|143006942|SUPERIORITY|A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.|Mean Difference (Net)|-0.85|||<|0.001|TWO_SIDED|95.0|-1.32|-0.38||The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.|ANOVA|The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.||Changes in units of the scale from baseline to 2 years||-0.38|-1.32|<0.001
71751821|NCT01183689|143006942|SUPERIORITY||Mean Difference (Net)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.57|0.37||This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||0.37|-0.57|<0.001
71751822|NCT01183689|143006943|SUPERIORITY|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|Mean Difference (Net)|0.2|||<|0.001|TWO_SIDED|95.0|-0.31|0.71||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints|ANOVA|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||0.71|-0.31|<0.001
71751823|NCT01183689|143006943|SUPERIORITY||Mean Difference (Net)|0.88||||0.002|TWO_SIDED|95.0|0.37|1.39||This p-value is from a 2 degree freedom test of differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.||1.39|0.37|0.002
71751824|NCT01183689|143006944|SUPERIORITY||Mean Difference (Net)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.71|0.45||2 degree of freedom F-test from analysis of variance|ANOVA|2 degree of freedom F-test from analysis of variance to compare mean differences among arms||2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline||0.45|-0.71|<0.001
71783570|NCT03766581|143065873|SUPERIORITY||Relative Risk (RR)|0.91|||||TWO_SIDED|95.0|0.69|1.31|||MCP-MOD|Multiple Comparison Procedures, MODel|95% confidence interval (CI) for composite event based on bootstrap (10000 samples)|Milvexian 200 mg BID over Placebo||1.31|0.69|
71783571|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.49|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg QD over Placebo||1.49|0.46|
71783572|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|0.69|||||TWO_SIDED|95.0|0.36|1.3|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 25 mg BID over Placebo||1.30|0.36|
71783573|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|0.72|||||TWO_SIDED|95.0|0.39|1.33|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg BID over Placebo||1.33|0.39|
71751825|NCT01183689|143006944|SUPERIORITY||Median Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|0.82|1.98||This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.||1.98|0.82|<0.001
71751826|NCT01183689|143006945|SUPERIORITY||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.24|0.09||This p-value is from a 2 degree of freedom test for differences among the 3 arms.|ANOVA|2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms||2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms||0.09|-0.24|0.24
71751827|NCT01183689|143006945|SUPERIORITY||Mean Difference (Net)|-0.15||||0.24|TWO_SIDED|95.0|-0.32|0.02||This p-value is from the 2 degree of freedom test of differences among the 3 arms.|ANOVA|||Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.||0.02|-0.32|0.24
71751828|NCT01183689|143006946|SUPERIORITY||Mean Difference (Net)|1.52||||0.16|TWO_SIDED|95.0|-0.77|3.81||This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.|ANOVA|||Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.||3.81|-0.77|0.16
71751829|NCT01183689|143006946|SUPERIORITY||Mean Difference (Net)|2.21||||0.16|TWO_SIDED|95.0|-0.09|4.51||This p-value is from a 2 degree of freedom F test.|ANOVA|||Analysis of variance was used to compared mean differences among the 3 groups.||4.51|-0.09|0.16
71751830|NCT01183689|143006947|SUPERIORITY||Mean Difference (Net)|0.17||||0.75|TWO_SIDED|95.0|-3.89|4.23||This p-value is from a 2 degree of freedom F-test from analysis of variance.|ANOVA|||Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||4.23|-3.89|0.75
71751831|NCT01183689|143006947|SUPERIORITY||Mean Difference (Net)|1.44||||0.75|TWO_SIDED|95.0|-2.61|5.49||This p-value is from a 2 degree of freedom test.|ANOVA||No significant differences between groups 1 and 3.|Analysis of variance was used to compare mean changes among the 3 groups.||5.49|-2.61|0.75
71751832|NCT01183689|143006948|SUPERIORITY||Mean Difference (Net)|-1.08||||0.05|TWO_SIDED|95.0|-2.44|0.28||This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.|ANOVA||No significant difference between groups 1 and 2.|Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.||0.28|-2.44|0.05
71751833|NCT01183689|143006948|SUPERIORITY||Mean Difference (Net)|-1.66||||0.05|TWO_SIDED|95.0|-3.0|-0.32||This p-value is from an F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.32|-3.00|0.05
71751834|NCT01183689|143006949|SUPERIORITY||Mean Difference (Net)|-0.46||||0.03|TWO_SIDED|95.0|-1.37|0.45||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.|ANOVA|||Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.||0.45|-1.37|0.03
71783574|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|0.65|||||TWO_SIDED|95.0|0.33|1.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg BID over Placebo||1.25|0.33|
71751835|NCT01183689|143006949|SUPERIORITY||Mean Difference (Net)|-1.21||||0.03|TWO_SIDED|95.0|-2.11|-0.3||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.||-0.30|-2.11|0.03
71751836|NCT01183689|143006950|SUPERIORITY||Mean Difference (Net)|1.08||||0.2|TWO_SIDED|95.0|-0.84|3.0||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.|ANOVA||The 95% confidence interval for differences between groups 1 and 2 includes 0.|Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.||3.00|-0.84|0.20
71751837|NCT01183689|143006950|SUPERIORITY||Mean Difference (Net)|-0.05||||0.2|TWO_SIDED|95.0|-1.45|1.35||This p-value is from an analysis of variance comparing all 3 groups.|ANOVA||The 95% confidence interval for differences between groups 1 and 3 includes 0.|Analysis of variance was used to compare differences among the 3 groups.||1.35|-1.45|0.20
71751838|NCT01183689|143006951|SUPERIORITY||Mean Difference (Net)|-0.12||||0.02|TWO_SIDED|95.0|-0.34|0.1||2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes|ANOVA|||2 degree of freedom F-test to compare mean 2 year differences among 3 arms||0.10|-0.34|0.02
71751839|NCT01183689|143006951|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|95.0|-0.52|-0.08||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.||-0.08|-0.52|0.02
71751840|NCT01183689|143006952|SUPERIORITY||Mean Difference (Net)|-52.0||||0.58|TWO_SIDED|95.0|-164.0|60.0||2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories|ANOVA|||2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2||60|-164|0.58
71751841|NCT01183689|143006952|SUPERIORITY||Mean Difference (Net)|-50.0||||0.58|TWO_SIDED|95.0|-162.0|61.0||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups|ANOVA|||Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.||61|-162|0.58
71751842|NCT01183689|143006953|SUPERIORITY||Mean Difference (Net)|-1.27||||0.001|TWO_SIDED|95.0|-2.55|0.02||2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms|ANOVA|No adjustment to degrees of freedom|Difference between groups 1 and 2: 95% confidence interval includes 0|2 degree of freedom F-test from ANOVA to compare differences among 3 arms||0.02|-2.55|0.001
71751843|NCT01183689|143006953|SUPERIORITY||Mean Difference (Net)|-2.42||||0.001|TWO_SIDED|95.0|-3.69|-1.14||The p-value is from a 2 degree of freedom F-test for differences among the 3 arms|ANOVA||The 95% confidence interval for differences between groups 1 and 3 does not include 0.|Mean change in waist girth from baseline to year 2||-1.14|-3.69|0.001
71751844|NCT01183689|143006954|SUPERIORITY|Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.|Odds Ratio (OR)|1.77||||0.004|TWO_SIDED|95.0|1.04|3.02||This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.|Regression, Logistic||The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.|Logistic regression to compare differences among the 3 groups||3.02|1.04|0.004
71751845|NCT01183689|143006954|SUPERIORITY||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.4|3.94||2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms|Regression, Logistic|No adjustments|The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.|Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.||3.94|1.40|0.004
71751846|NCT01419236|143006956|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.38|TWO_SIDED|90.0|-0.59|1.91|||Mixed Models Repeated Measure Analysis|||||1.91|-0.59|0.380
71751847|NCT01419236|143006957|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.164|TWO_SIDED|90.0|-0.96|0.08|||Mixed Models Repeated Measures Analysis|||||0.08|-0.96|0.164
71751848|NCT01419236|143006958|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.342|TWO_SIDED|90.0|-0.31|1.15|||Mixed Models Repeated Measure Analysis|||||1.15|-0.31|0.342
71751849|NCT01419236|143006959|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.079|TWO_SIDED|90.0|0.05|1.57|||Mixed Models Repeated Measure Analysis|||||1.57|0.05|0.079
71751850|NCT01419236|143006960|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.535|TWO_SIDED|90.0|-0.5|1.1|||Mixed Models Repeated Measure Analysis|||||1.10|-0.50|0.535
71751851|NCT01419236|143006961|SUPERIORITY_OR_OTHER||LS Mean Difference|1.03||||0.172|TWO_SIDED|90.0|-0.22|2.27|||ANCOVA|||||2.27|-0.22|0.172
71751852|NCT01419236|143006962|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.473|TWO_SIDED|90.0|-0.41|1.04|||Mixed Models Repeated Measure Analysis|||||1.04|-0.41|0.473
71751853|NCT01419236|143006963|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.885|TWO_SIDED|90.0|-1.03|0.87|||Mixed Models Repeated Measure Analysis|||||0.87|-1.03|0.885
71751854|NCT01419236|143006964|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.938|TWO_SIDED|90.0|-0.61|0.55|||Mixed Models Repeated Measure Analysis|||||0.55|-0.61|0.938
71751855|NCT02849418|143006965|OTHER||Mean Difference (Net)|-3.02|||||TWO_SIDED|95.0|-5.85|-0.19|||||The analysis method was mixed-model for repeated measures (MMRM) with treatment, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|||-0.19|-5.85|
71751856|NCT00762359|143007045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.0989|||<|0.0001|TWO_SIDED|95.0|0.0425|0.23|||Log Rank|||||0.2300|0.0425|<0.0001
71751857|NCT00762359|143007046|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71751858|NCT00762359|143007047|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71751859|NCT00762359|143007048|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
71751860|NCT00762359|143007049|SUPERIORITY_OR_OTHER|||||||0.0433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0433
71751861|NCT00762359|143007051|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71751862|NCT00762359|143007052|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
71751863|NCT00762359|143007053|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0025
71751864|NCT00762359|143007054|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0010
71751865|NCT00762359|143007056|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
71751866|NCT00762359|143007057|SUPERIORITY_OR_OTHER|||||||0.6148||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6148
71751867|NCT00762359|143007058|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8050
71751868|NCT00762359|143007059|SUPERIORITY_OR_OTHER|||||||0.8678||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8678
71751869|NCT00762359|143007060|SUPERIORITY_OR_OTHER|||||||0.2688||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2688
71751870|NCT00762359|143007062|SUPERIORITY_OR_OTHER|||||||0.7054||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7054
71751871|NCT00762359|143007063|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3400
71751872|NCT00762359|143007064|SUPERIORITY_OR_OTHER|||||||0.8813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8813
71751873|NCT00762359|143007065|SUPERIORITY_OR_OTHER|||||||0.1862||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1862
71751874|NCT00762359|143007067|SUPERIORITY_OR_OTHER|||||||0.8604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8604
71751875|NCT00762359|143007068|SUPERIORITY_OR_OTHER|||||||0.5485||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5485
71751876|NCT00762359|143007069|SUPERIORITY_OR_OTHER|||||||0.7382||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7382
71751877|NCT00762359|143007070|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7619
71751878|NCT00762359|143007072|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0204
71751879|NCT00762359|143007073|SUPERIORITY_OR_OTHER|||||||0.0046||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0046
71751880|NCT00762359|143007074|SUPERIORITY_OR_OTHER|||||||0.0059||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0059
71751881|NCT00762359|143007075|SUPERIORITY_OR_OTHER|||||||0.1229||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1229
71751882|NCT00762359|143007077|SUPERIORITY_OR_OTHER|||||||0.2694||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2694
71751883|NCT00762359|143007078|SUPERIORITY_OR_OTHER|||||||0.0141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0141
71751884|NCT00762359|143007079|SUPERIORITY_OR_OTHER|||||||0.3128||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3128
71751885|NCT00762359|143007080|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1450
71751886|NCT00762359|143007082|SUPERIORITY_OR_OTHER|||||||0.6175||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6175
71751887|NCT00762359|143007083|SUPERIORITY_OR_OTHER|||||||0.4496||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4496
71751888|NCT00762359|143007084|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4718
71751889|NCT00762359|143007085|SUPERIORITY_OR_OTHER|||||||0.4484||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4484
71751890|NCT00762359|143007087|SUPERIORITY_OR_OTHER|||||||0.2604||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2604
71751891|NCT00762359|143007088|SUPERIORITY_OR_OTHER|||||||0.6818||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6818
71751892|NCT00762359|143007089|SUPERIORITY_OR_OTHER|||||||0.9015||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9015
71751893|NCT00762359|143007090|SUPERIORITY_OR_OTHER|||||||0.4497||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.4497
71751894|NCT03287791|143007129|SUPERIORITY||Mean Difference (Final Values)|-11.27|||<|0.0001|TWO_SIDED|95.0|-16.8|-5.73|||ANOVA|||Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-5.73|-16.80|<.0001
71891731|NCT00826514|143304941|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-33.56|STANDARD_ERROR_OF_MEAN|17.026|||TWO_SIDED|90.0|-64.144|-2.968||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||-2.968|-64.144|
71891732|NCT00826514|143304942|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-1.364|0.415||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.415|-1.364|
71891733|NCT00826514|143304943|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-3.146|0.401||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.401|-3.146|
71891734|NCT00826514|143304944|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|90.0|-0.417|0.334||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||0.334|-0.417|
71668927|NCT02854527|142854355|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|102.62|STANDARD_DEVIATION|20.4|||TWO_SIDED|90.0|93.82|112.25|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R2.||112.25|93.82|
71668928|NCT02854527|142854356|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|103.96|STANDARD_DEVIATION|24.0|||TWO_SIDED|90.0|93.6|115.46|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R2.||115.46|93.60|
71751895|NCT03287791|143007129|SUPERIORITY||Median Difference (Final Values)|-9.71||||0.0007|TWO_SIDED|95.0|-15.28|-4.14|||ANOVA|||Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.||-4.14|-15.28|0.0007
71751896|NCT02250326|143007148|SUPERIORITY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.94||||Based on stratification factors of ECOG Performance Status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||1.94|0.90|
71751897|NCT02250326|143007149|SUPERIORITY||Disease Control Rate Ratio|0.97|||||TWO_SIDED|95.0|0.778|1.207|||||95% CI was calculated using Clopper-Pearson method.||Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone|1.207|0.778|
71891735|NCT00826514|143304945|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.765|||TWO_SIDED|90.0|-1.791|1.822||||||Change at Week 6: Analysis was based on ANCOVA model with baseline value, age, baseline pain stratification group and treatment as covariates.||1.822|-1.791|
71891736|NCT00826514|143304946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.833|||||TWO_SIDED|90.0|0.763|4.407||||||Week 6: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||4.407|0.763|
71751898|NCT02250326|143007150|SUPERIORITY||Overall Response Rate Ratio|0.84|||||TWO_SIDED|95.0|0.398|1.754|||||95% CI was calculated using Clopper-Pearson method.||Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.|1.754|0.398|
71751899|NCT02250326|143007151|SUPERIORITY||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|1.08|2.57||||Based on stratification factors of ECOG performance status (0 or 1), sex (male or female), and current smoker status (yes or no).||Based on stratified Cox proportional hazards regression model.||2.57|1.08|
71783575|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|1.4|||||TWO_SIDED|95.0|0.87|2.25|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 200 mg BID||2.25|0.87|
71783576|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|2.48|||||TWO_SIDED|95.0|0.83|7.42|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 50 mg QD over Placebo||7.42|0.83|
71783577|NCT03766581|143065895|SUPERIORITY||Relative Risk (RR)|1.01|||||TWO_SIDED|95.0|0.15|6.96|||Wald Confidence Limits|95% CIs for RR are constructed using Wald Confidence Limits||Milvexian 100 mg QD over Placebo||6.96|0.15|
71891737|NCT00826514|143304946|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|||||TWO_SIDED|90.0|0.388|2.575||||||Week 16: Logistic regression model with age, baseline pain stratification group and treatment as covariates.||2.575|0.388|
71891738|NCT01834404|143305042|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||ANCOVA|||||||0.057
71891739|NCT01834404|143305043|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||||||0.052
71891740|NCT01834404|143305044|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||ANCOVA|||||||0.36
71891741|NCT01834404|143305045|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|||||||0.99
71891742|NCT01834404|143305046|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||||||0.45
71891743|NCT01834404|143305047|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
71891744|NCT01834404|143305048|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||||||0.032
71891745|NCT01834404|143305049|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This p-value was based on a rank transformation.||||0.030
71891746|NCT01834404|143305050|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||ANCOVA|||||||0.35
71891747|NCT01834404|143305051|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|||||||0.72
71891748|NCT01834404|143305052|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||ANCOVA|||||||0.90
71668929|NCT02854527|142854357|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.49|STANDARD_DEVIATION|9.0|||TWO_SIDED|90.0|93.54|101.61|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R3.||101.61|93.54|
71668930|NCT02854527|142854358|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|98.25|STANDARD_DEVIATION|14.7|||TWO_SIDED|90.0|91.85|105.09|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R3.||105.09|91.85|
71668931|NCT02854527|142854359|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|105.01|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|96.39|114.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R4.||114.40|96.39|
71668932|NCT02854527|142854360|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|104.28|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|94.95|114.53|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R4.||114.53|94.95|
71668933|NCT02854527|142854361|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R1) (%)|96.53|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|92.08|101.2|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R1.||101.20|92.08|
71668934|NCT02854527|142854362|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R2) (%)|97.4|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|90.87|104.41|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R2.||104.41|90.87|
71668935|NCT02854527|142854363|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R3) (%)|97.5|STANDARD_DEVIATION|8.9|||TWO_SIDED|90.0|93.58|101.58|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R3.||101.58|93.58|
71751900|NCT04673214|143007164|SUPERIORITY|The null hypothesis for the modification in the clinical evolution of the conjunctivitis sign in patients diagnosed with COVID-19 under early intervention treatment with Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call is rejected.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms|Chi-squared|||Null Hypothesis: There will be no modification in the clinical evolution ≥ 25% of patients diagnosed with COVID-19 under an early intervention treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol for 14 days followed by video call from U.M.F 13 and U.M.F 20 from I.M.S.S., during the period of December 2020- February 2021, with a power of 90%, type I error rate 1% and loss to follow-up 20%.||||0.05
71783578|NCT05275400|143065917|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Difference|-0.089|||||TWO_SIDED|95.0|-0.191|0.013||||||||0.013|-0.191|
71783579|NCT05275400|143065918|SUPERIORITY||LS Mean Difference|-0.089||||0.088|TWO_SIDED|95.0|-0.191|0.013|||ANCOVA|||||0.013|-0.191|0.088
71783580|NCT05275400|143065919|SUPERIORITY||Relative rate|1.03||||0.897|TWO_SIDED|95.0|0.62|1.74|||Negative binomial model|||||1.74|0.62|0.897
71783581|NCT05275400|143065920|SUPERIORITY||LS Mean Difference|0.42||||0.722|TWO_SIDED|95.0|-1.88|2.72|||ANCOVA|||||2.72|-1.88|0.722
71783582|NCT05275400|143065921|SUPERIORITY||LS Mean Difference|-0.84||||0.605|TWO_SIDED|95.0|-4.01|2.33|||ANCOVA|||||2.33|-4.01|0.605
71783583|NCT05275400|143065922|SUPERIORITY||LS Mean Difference|-30.0||||0.003|TWO_SIDED|95.0|-50.1|-9.97|||Mixed Models Analysis|||||-9.97|-50.10|0.003
71783584|NCT05275400|143065923|SUPERIORITY||Relative rate|1.14||||0.43|TWO_SIDED|95.0|0.83|1.56|||Negative binomial model|||||1.56|0.83|0.430
71783585|NCT05275400|143065924|SUPERIORITY||LS Mean Difference|0.071||||0.756|TWO_SIDED|95.0|-0.38|0.52|||Mixed Models Analysis|||||0.52|-0.38|0.756
71783586|NCT05275400|143065925|SUPERIORITY||LS Mean Difference|0.14||||0.021|TWO_SIDED|95.0|0.02|0.27|||ANCOVA|||||0.27|0.02|0.021
71783587|NCT05275400|143065926|SUPERIORITY||LS Mean Difference|-0.99||||0.417|TWO_SIDED|95.0|-3.37|1.4|||ANCOVA|||||1.40|-3.37|0.417
71783588|NCT05275400|143065927|SUPERIORITY||LS Mean Difference|3.15|||<|0.001|TWO_SIDED|95.0|1.71|4.59|||Mixed Models Analysis|||Week 26||4.59|1.71|<0.001
71751901|NCT04673214|143007164|SUPERIORITY|The null hypothesis is rejected with a difference of 2 days in the modification of the clinical evolution (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID -19 in early intervention treatment. vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||||0.05|||||||t-test, 2 sided|||Assuming a difference of 2 days in the modification of the clinical course (symptoms of fever, cough, headache, myalgia, odynophagia, anosmia, rhinorrhea, arthralgia, chest pain, dyspnea, conjunctivitis) of patients diagnosed with COVID-19 in early intervention treatment vs. therapeutic failure, for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of the twenty%||||0.05
71891749|NCT01834404|143305053|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
71751902|NCT04673214|143007165|SUPERIORITY|Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with the outcome of improvement in the Modification of the clinical evolution of the symptoms of patients with COVID-19 using double therapy was reported 95.7% (n = 44) Vs. triple therapy 90.8% (n = 59) and therapeutic failure 4.3% (n = 2) vs. 9.2% (n = 6), respectively.||||||0.05||||||Presence of a p \<0.05 as significant in the comparison of treatment with clinical symptoms the clinical modification and therapeutic failure of patients diagnosed with COVID-19|Chi-squared|||Assuming a difference in the percentage of effectiveness in the clinical modification and therapeutic failure of patients diagnosed with COVID-19 under treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a power of 90%, a type I error rate of 1% and a loss to follow-up of 20%||||0.05
71751903|NCT04673214|143007166|SUPERIORITY|The null hypothesis is rejected with a mean duration of 2 days with clinical symptoms of COVID-19 in early intervention treatment as a result of improving the modification of the clinical evolution of symptoms vs therapeutic failure.||||||0.05|||||||t-test, 2 sided|||Assuming a difference in days of effectiveness in clinical modification and therapeutic failure of patients diagnosed with COVID-19 in treatment with Azithromycin / Ivermectin / Ribaroxaban / Paracetamol vs. Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call, with a potency 90%, a Type I error rate of 1%, and a loss to follow-up of 20%||||0.05
71751904|NCT04673214|143007167|SUPERIORITY|A total of 62 patients was calculated, however due to the availability of medication, it was recalculated to 111 patients, that is, 65 cases in the triple therapy group and 46 in the double therapy group would be necessary for the analysis.||||||0.05|||||||Wilcoxon (Gehan) statistical test|||Assuming a 25% efficacy in modifying the clinical course (COVID-19 mild phase symptoms) of patients with COVID-19 under a comparative treatment for 14 days followed by video call, with a power of 90%, type I error rate 1% and loss to follow-up 20%||||0.05
71751905|NCT05635461|143007175|OTHER||Geometric Mean Ratio|60.13|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
71751906|NCT05635461|143007176|OTHER||Geometric Mean Ratio|60.12|||||TWO_SIDED|90.0|56.12|64.42|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||64.42|56.12|
71751907|NCT05635461|143007177|OTHER||Geometric Mean Ratio|27.94|||||TWO_SIDED|90.0|25.09|31.13|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet fasted) and reference (CVN424 suspension fasted).|||31.13|25.09|
71751908|NCT05635461|143007178|OTHER||Median Difference (Final Values)|1.04|||<|0.0001|TWO_SIDED|90.0|0.9265|2.247|||ANOVA|||||2.2470|0.9265|<0.0001
71751909|NCT05635461|143007178|OTHER||Median Difference (Final Values)|2.78|||<|0.0001|TWO_SIDED|90.0|2.4475|3.0035|||ANOVA|||||3.0035|2.4475|<0.0001
71751910|NCT05635461|143007179|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0||||||||0.000|0.000|
71751911|NCT05635461|143007179|OTHER||Median Difference (Final Values)|0.25||||0.001|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0010
71783589|NCT05275400|143065927|SUPERIORITY||LS Mean Difference|3.56|||<|0.001|TWO_SIDED|95.0|2.05|5.07|||Mixed Models Analysis|||Week 52||5.07|2.05|<0.001
71783590|NCT05275400|143065927|SUPERIORITY||LS Mean Difference|3.35|||<|0.001|TWO_SIDED|95.0|1.75|4.94|||Mixed Models Analysis|||Week 78||4.94|1.75|<0.001
71783591|NCT02585960|143065931|SUPERIORITY||Gaussian Statistic estimate|1.96||||0.0545|TWO_SIDED|95.0|-0.038|3.958|||Chi-squared||Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.|The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.||3.958|-0.038|0.0545
71783592|NCT02197247|143065987|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% confidence intervals (CIs) for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric least-squares (LS) mean ratio|27.16|||||TWO_SIDED|90.0|24.36|30.29|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed Css,max values were compared between periods using a mixed effects analysis of variance (ANOVA) with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both area under the plasma concentration-time curve during the dosing interval (AUCtau) and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||30.29|24.36|
71891750|NCT01834404|143305054|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.26
71896219|NCT01709799|143314378|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,93.240)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||<0.001
71751912|NCT05635461|143007180|OTHER||Geometric Mean Ratio|161.57|||||TWO_SIDED|90.0|150.96|172.92|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.92|150.96|
71751913|NCT05635461|143007181|OTHER||Geometric Mean Ratio|161.59|||||TWO_SIDED|90.0|150.98|172.95|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||172.95|150.98|
71668936|NCT02854527|142854364|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Geometric mean ratio (T/R4) (%)|107.63|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|97.04|119.39|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects: 'sequence', 'subject within sequence', 'period' and 'treatment'.|Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R4.||119.39|97.04|
71668937|NCT03093259|142854372|OTHER|One-sided 10% significance level||||||0.2096|||||||Chi-squared|||||||0.2096
71668938|NCT03093259|142854373|OTHER|||||||0.1588|||||||Chi-squared|||||||0.1588
71668939|NCT03093259|142854374|OTHER|||||||0.483|||||||ANCOVA|||||||0.4830
71668940|NCT03093259|142854375|OTHER|||||||0.0742|||||||ANCOVA|||||||0.0742
71668941|NCT03093259|142854376|OTHER|||||||0.0462|||||||ANCOVA|||||||0.0462
71668942|NCT02575833|142854377|NON_INFERIORITY|The non-inferiority margin was -90 seconds.|Treatment Difference|-11.0|STANDARD_ERROR_OF_MEAN|20.4|||TWO_SIDED|90.0|-44.9|22.9||||||The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (\< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.||22.9|-44.9|
71668943|NCT02575833|142854378|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|1.55||||0.69|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.69
71668944|NCT02575833|142854378|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.69|TWO_SIDED|90.0|0.73|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.69|0.73|0.69
71668945|NCT02575833|142854378|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.44|TWO_SIDED|90.0|0.52|1.26|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.26|0.52|0.44
71668946|NCT02575833|142854378|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.47|TWO_SIDED|90.0|0.52|1.28|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.|||1.28|0.52|0.47
71668947|NCT02575833|142854379|SUPERIORITY|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|2.2||||0.59|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (\< 7 minutes or ≥ 7 minutes).|A normal score \< 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.|||||0.59
71751914|NCT05635461|143007182|OTHER||Geometric Mean Ratio|304.19|||||TWO_SIDED|90.0|273.51|338.31|||||Geometric mean ratio was obtained by multiplying 100 with ratio of test (CVN424 tablet Fed) and reference (CVN424 tablet fasted).|||338.31|273.51|
71751915|NCT05635461|143007183|OTHER||Median Difference (Final Values)|0.99||||0.0662|TWO_SIDED|90.0|0.006|1.537|||ANOVA|||||1.5370|0.0060|0.0662
71751916|NCT05635461|143007184|OTHER||Median Difference (Final Values)|0.25||||0.0039|TWO_SIDED|90.0|0.0|0.251|||ANOVA|||||0.2510|0.0000|0.0039
71751917|NCT02646826|143007188|SUPERIORITY|||||||0.0017|||||||ANOVA|||||||0.0017
71751918|NCT02646826|143007189|SUPERIORITY||||||<|0.44|||||||ANOVA|||||||<.44
71751919|NCT00614575|143007198|SUPERIORITY_OR_OTHER||Mean change from baseline|-7.2|STANDARD_DEVIATION|9.0|<|0.0001|||||||Paired t-test|||||||<0.0001
71668948|NCT02575833|142854379|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|90.0|0.76|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (\< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.69|0.76|0.59
71668949|NCT02575833|142854379|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|90.0|0.73|1.6|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.60|0.73|0.75
71751920|NCT00614575|143007199|SUPERIORITY_OR_OTHER||Mean change from baseline|-4.8|STANDARD_DEVIATION|7.8|<|0.0001|||||||Paired t-test|||||||<0.0001
71751921|NCT00614575|143007200|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.7|STANDARD_DEVIATION|0.9|<|0.0001|||||||paired t-test|||||||<0.0001
71751922|NCT00614575|143007201|SUPERIORITY_OR_OTHER||mean change from baseline|-0.3|STANDARD_DEVIATION|0.6|<|0.0001|||||||paired t-test|||||||<0.0001
71751923|NCT04664153|143007217|SUPERIORITY||Mean Difference (Final Values)|-39.4|STANDARD_ERROR_OF_MEAN|11.74||0.0004|TWO_SIDED|90.0|-58.76|-20.12|||t-test, 1 sided|||||-20.12|-58.76|0.0004
71751924|NCT04664153|143007218|SUPERIORITY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|90.0|-7.02|-2.77|||t-test, 1 sided|||||-2.77|-7.02|<0.0001
71751925|NCT00097500|143007236|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71751926|NCT00097500|143007237|SUPERIORITY_OR_OTHER|||||||0.4185||95.0|||||ANCOVA|||||||0.4185
71751927|NCT00097500|143007238|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
71751928|NCT00097500|143007238|SUPERIORITY_OR_OTHER|||||||0.1188||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1188
71751929|NCT00097500|143007239|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical analysis at week 52.||||<0.0001
71751930|NCT00097500|143007239|SUPERIORITY_OR_OTHER|||||||0.1996||95.0|||||ANCOVA|||Statistical analysis at week 56.||||0.1996
71751931|NCT00097500|143007240|SUPERIORITY_OR_OTHER|||||||0.5522||95.0|||||ANCOVA|||||||0.5522
71751932|NCT00097500|143007241|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71751933|NCT00097500|143007243|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71751934|NCT00189098|143007261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-25.0|||||TWO_SIDED|95.0|-44.0|-6.0|||risk differences (RD)||Risk difference and 95% confidence intervals reported for 6 weeks follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||-6|-44|
71751935|NCT00189098|143007261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||||TWO_SIDED|95.0|-34.0|4.0|||risk difference (RD)||Risk difference and confidence interval reported for 12 week follow-up|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||4|-34|
71751936|NCT00189098|143007261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-12.0|22.0|||risk difference (RD)||Risk difference and confidence interval reported for 1 year follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."||22|-12|
71751937|NCT00189098|143007262|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.0|||||TWO_SIDED|95.0|-34.0|10.0|||rate differences (95%CI intervals)||Risk difference and confidence interval reported for eardrop usage between 6 and 12 weeks follow-up.|||10|-34|
71751938|NCT00189098|143007263|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-22.0|14.0|||rate difference (RD)||Risk difference and confidence interval reported for eardrop usage between 12 weeks and 1 year follow-up.|||14|-22|
71751939|NCT00189098|143007264|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-23.0|9.0|||Rate differences (95%CI interval)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 6 to 12 weeks follow-up.|||9|-23|
71751940|NCT00189098|143007265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0|||||TWO_SIDED|95.0|-7.0|37.0|||Rate difference (RD)||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 12 weeks and 1 year follow-up.|||37|-7|
71751941|NCT00189098|143007266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.0|||||TWO_SIDED|95.0|-12.0|24.0|||Rate differences (95%CI intervals)||Risk difference and confidence interval reported for participants who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.|||24|-12|
71751942|NCT00474123|143007274|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Wilcoxon (Mann-Whitney)|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.3
71751943|NCT00474123|143007275|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.65
71751944|NCT00474123|143007276|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.02
71751945|NCT00474123|143007277|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.||||0.85
71751946|NCT01650558|143007315|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.27|||<=|0.05|TWO_SIDED|95.0|0.89|1.82||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.82|0.89|<=0.05
71751947|NCT01650558|143007315|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.28|||<=|0.05|TWO_SIDED|95.0|0.89|1.83||P-Value is not adjusted for multiple comparisons.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.83|0.89|<=0.05
71836039|NCT03526861|143177416|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|25.5|||<|0.001|TWO_SIDED|95.0|15.3|35.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects who achieved at least 50% reduction in SCORAD at Week 16 were considered responders. Subjects with missing data or subjects who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||35.7|15.3|<0.001
71836040|NCT03526861|143177417|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.5|||<|0.001|TWO_SIDED|95.0|-2.4|-0.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.6|-2.4|<0.001
71836041|NCT03526861|143177417|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-1.2||||0.007|TWO_SIDED|95.0|-2.1|-0.3||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-0.3|-2.1|0.007
71751948|NCT01650558|143007316|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.38|||<=|0.05|TWO_SIDED|95.0|0.83|2.3||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.30|0.83|<=0.05
71751949|NCT01650558|143007316|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.51|||<=|0.05|TWO_SIDED|95.0|0.91|2.49||No adjustment for multiple comparisons was made.|Fisher Exact|||||2.49|0.91|<=0.05
71783593|NCT02197247|143065988|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% CIs for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric LS Mean Ratio|21.55|||||TWO_SIDED|90.0|19.5|23.83|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both AUCtau and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.||23.83|19.50|
71783594|NCT02197247|143065989|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.53|||||TWO_SIDED|90.0|85.27|107.03|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||107.03|85.27|
71783595|NCT02197247|143065990|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|21.72|||||TWO_SIDED|90.0|19.08|24.72|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||24.72|19.08|
71783596|NCT02197247|143065990|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|88.31|||||TWO_SIDED|90.0|77.17|101.07|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||101.07|77.17|
71783597|NCT02197247|143065991|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|139.32|||||TWO_SIDED|90.0|127.74|151.96|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||151.96|127.74|
71783598|NCT02197247|143065991|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.75|||||TWO_SIDED|90.0|92.04|110.29|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.29|92.04|
71783599|NCT02197247|143065993|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|95.89|||||TWO_SIDED|90.0|86.37|106.45|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||106.45|86.37|
71668950|NCT02575833|142854379|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.39|TWO_SIDED|90.0|0.82|1.87|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (\< 7 or ≥ 7 minutes), age group (\< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.|||1.87|0.82|0.39
71751950|NCT01650558|143007317|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.13|||<=|0.05|TWO_SIDED|95.0|0.66|1.93||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.93|0.66|<=0.05
71751951|NCT01650558|143007317|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|0.96|||<=|0.05|TWO_SIDED|95.0|0.55|1.68||No adjustments for multiple comparisons were made.|Fisher Exact|||||1.68|0.55|<=0.05
71783600|NCT02197247|143065994|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|18.76|||||TWO_SIDED|90.0|16.61|21.19|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||21.19|16.61|
71783601|NCT02197247|143065994|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|90.08|||||TWO_SIDED|90.0|79.34|102.27|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||102.27|79.34|
71783602|NCT02197247|143065995|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|129.81|||||TWO_SIDED|90.0|119.14|141.44|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||141.44|119.14|
71783603|NCT02197247|143065995|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|100.76|||||TWO_SIDED|90.0|92.15|110.19|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.||110.19|92.15|
71783604|NCT01619423|143066005|SUPERIORITY||Odds Ratio (OR)|0.78||||0.31|ONE_SIDED|10.0||1.5|||Cochran-Mantel-Haenszel|||||1.5||0.31
71783605|NCT01619423|143066005|SUPERIORITY||Odds Ratio (OR)|0.55||||0.15|ONE_SIDED|10.0||1.16|||Cochran-Mantel-Haenszel|||||1.16||0.15
71783606|NCT01619423|143066005|SUPERIORITY||Odds Ratio (OR)|0.62||||0.16|ONE_SIDED|10.0||1.14|||Cochran-Mantel-Haenszel|||||1.14||0.16
71783607|NCT02340975|143066029|OTHER|Comparison|Mean Difference (Net)|11.1||||0.2376|TWO_SIDED|95.0|-0.7|23.0|||Fisher Exact|||||23.0|-0.7|0.2376
71783608|NCT02340975|143066029|OTHER|Comparison|Median Difference (Net)|2.8||||1|TWO_SIDED|95.0|-16.8|22.4|||Fisher Exact|||||22.4|-16.8|1.0000
71783609|NCT01288235|143066061|OTHER||3-Year Cumulative incidence|14.5|||||TWO_SIDED|95.0|8.3|22.3||||||||22.3|8.3|
71783610|NCT01288235|143066061|OTHER||5-Year Cumulative incidence|20.2|||||TWO_SIDED|95.0|12.7|28.9||||||||28.9|12.7|
71783611|NCT01288235|143066062|OTHER||Mean Difference (Net)|1.1||||0.543|TWO_SIDED|95.0|-2.6|4.9|||t-test, 2 sided|Paired t test||||4.9|-2.6|0.543
71783612|NCT01288235|143066063|OTHER||3-Year Local Disease Control Probability|89.9|||||TWO_SIDED|95.0|83.1|94.9||||||||94.9|83.1|
71783613|NCT01288235|143066063|OTHER||5-Year Local Disease Control Probability|85.9|||||TWO_SIDED|95.0|78.2|91.9||||||||91.9|78.2|
71783614|NCT01288235|143066063|OTHER||3-Year Distant Disease Control|97.0|||||TWO_SIDED|95.0|92.1|99.2||||||||99.2|92.1|
71783615|NCT01288235|143066063|OTHER||5-Year Distant Disease Control|95.0|||||TWO_SIDED|95.0|89.4|98.1||||||||98.1|89.4|
71783616|NCT01288235|143066064|OTHER||3-Year Cumulative incidence of grade 3+|12.2|||||TWO_SIDED|95.0|6.6|19.5||||||||19.5|6.6|
71783617|NCT01288235|143066064|OTHER||5-Year Cumulative incidence of grade 3+|16.3|||||TWO_SIDED|95.0|9.8|24.3||||||||24.3|9.8|
71783618|NCT01288235|143066065|OTHER||3-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
71783619|NCT01288235|143066065|OTHER||5-Year Cumulative inc. of hearing loss|12.5|||||TWO_SIDED|95.0|2.9|29.5||||||||29.5|2.9|
71783620|NCT01697566|143066107|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Body Weight||||0.006
71783621|NCT01697566|143066107|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Fat Mass||||<0.001
71783622|NCT01697566|143066109|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
71783623|NCT01930123|143066111|OTHER||Mean Difference (Final Values)|6.26|STANDARD_DEVIATION|9.98||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.01
71783624|NCT01930123|143066112|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Mild fibrosis vs. advanced fibrosis||||0.006
71783625|NCT01930123|143066113|OTHER||Median Difference (Final Values)|56.7|STANDARD_DEVIATION|2.6||0.09|TWO_SIDED||||||t-test, 1 sided|||||||0.09
71783626|NCT01447433|143066120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.439|STANDARD_ERROR_OF_MEAN|0.56||0.441|TWO_SIDED|95.0|-0.7|1.58|||t-test, 2 sided|||||1.58|-0.70|0.441
71783627|NCT01447433|143066121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_ERROR_OF_MEAN|0.41||0.038|TWO_SIDED|95.0|0.05|1.7|||t-test, 2 sided|||Body Fat Mass||1.70|0.05|0.038
71783628|NCT01447433|143066121|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.082|TWO_SIDED|95.0|-1.06|0.07|||t-test, 2 sided|||Body Lean Mass||0.07|-1.06|0.082
71751952|NCT01650558|143007318|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.47|||<=|0.05|TWO_SIDED|95.0|1.07|2.0||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||2.00|1.07|<=0.05
71751953|NCT01650558|143007318|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.43|||<=|0.05|TWO_SIDED|95.0|1.04|1.96||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.96|1.04|<=0.05
71751954|NCT01650558|143007319|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.31|||<=|0.05|TWO_SIDED|95.0|1.11|1.55||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.55|1.11|<=0.05
71751955|NCT01650558|143007319|NON_INFERIORITY|Will assess performance of each experimental group relative to TS with a noninferiority margin for 1-HR of 0.35 to test the null (1-HR ≥ 0.35) and alternative (1-HR \< 0.35) hypotheses. Each experimental group will be declared noninferior to TS if the upper bound of the 95% confidence interval of 1-HR is below 0.35. For ease of interpretation, the HRs have been recast with TS as the reference group, such that HRs greater than 1 indicate an increase in the experimental hazard rate relative to TS.|Hazard Ratio (HR)|1.34|||<=|0.05|TWO_SIDED|95.0|1.14|1.58||No adjustments for multiple comparisons were made.|Poisson|Rate ratio confidence intervals and p-values were adjusted for overdispersion using the Pearson's chi-square scale.||||1.58|1.14|<=0.05
71751956|NCT02732600|143007323|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.59||0.39|TWO_SIDED|95.0|-0.66|1.68|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||1.68|-0.66|0.39
71751957|NCT02732600|143007323|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.71||0.35|TWO_SIDED|95.0|-0.75|2.06|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.06|-0.75|0.35
71677099|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|||<|0.0001|TWO_SIDED|95.0|-20.98|-10.75||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-10.75|-20.98|<0.0001
71751958|NCT02732600|143007323|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.81||0.21|TWO_SIDED|95.0|-0.57|2.6|||t-test, 2 sided|||Analysis 1 is Comparison Across Conditions at BASELINE Analysis 2 is Comparison Across Conditions at 6 Months Analysis 3 is Comparison Across Conditions at 1 year||2.60|-0.57|0.21
71783629|NCT01447433|143066121|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.018|TWO_SIDED|95.0|0.03|0.32|||t-test, 2 sided|||Visceral Fat Mass||0.32|0.03|0.018
71783630|NCT01447433|143066122|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.49||0.031|TWO_SIDED|95.0|0.1|2.09|||t-test, 2 sided|||||2.09|0.10|0.031
71783631|NCT01447433|143066123|SUPERIORITY_OR_OTHER||Median Difference (Net)|5.72|STANDARD_ERROR_OF_MEAN|2.25||0.016|TWO_SIDED|95.0|1.15|10.29|||t-test, 2 sided|||||10.29|1.15|0.016
71783632|NCT01447433|143066124|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.14|STANDARD_ERROR_OF_MEAN|1.7||0.508|TWO_SIDED|95.0|-2.31|4.58|||t-test, 2 sided|||Waist Circumference||4.58|-2.31|0.508
71783633|NCT01447433|143066124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|2.07||0.56|TWO_SIDED|95.0|-5.42|2.98|||t-test, 2 sided|||Abdominal Circumference||2.98|-5.42|0.560
71783634|NCT01447433|143066124|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|0.85||0.255|TWO_SIDED|95.0|-0.74|2.7|||t-test, 2 sided|||Hip Circumference||2.70|-0.74|0.255
71783635|NCT01447433|143066125|SUPERIORITY_OR_OTHER||Median Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|4.5||0.404|TWO_SIDED|95.0|-12.9|5.3|||t-test, 2 sided|||Systolic Blood Pressure||5.3|-12.9|0.404
71783636|NCT01447433|143066125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|3.18||0.768|TWO_SIDED|95.0|-5.52|7.41|||t-test, 2 sided|||Diastolic Blood Pressure||7.41|-5.52|0.768
71783637|NCT01447433|143066126|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.565|TWO_SIDED|95.0|-0.36|0.2|||t-test, 2 sided|||TC||0.20|-0.36|0.565
71783638|NCT01447433|143066126|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.15||0.636|TWO_SIDED|95.0|-0.24|0.39|||t-test, 2 sided|||TG||0.39|-0.24|0.636
71783639|NCT01447433|143066126|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.112|TWO_SIDED|95.0|-0.58|0.06|||t-test, 2 sided|||HDL||0.06|-0.58|0.112
71783640|NCT01447433|143066126|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.15||0.647|TWO_SIDED|95.0|-0.11|0.05|||t-test, 2 sided|||LDL||0.05|-0.11|0.647
71783641|NCT01447433|143066127|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.26|TWO_SIDED|95.0|-0.1|0.35|||t-test, 2 sided|||||0.35|-0.10|0.260
71783642|NCT01447433|143066128|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.87|STANDARD_ERROR_OF_MEAN|1.63||0.598|TWO_SIDED|95.0|-2.44|4.17|||t-test, 2 sided|||||4.17|-2.44|0.598
71668951|NCT00550459|142854383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|0.55||0.08|TWO_SIDED|95.0|-0.03|0.5||Secondary endpoints were ordered in 5 tiers to be analyzed only when \>=1 of the endpoints in the prior tier were significant. Since primary endpoint not stat significant, analyses of secondary endpoint tiers presented for exploratory purposes only|ANCOVA|ANCOVA with factors of treatment, disease severity, age(6 Degrees of Freedom), and covariate baseline to fit primary endpoint using the ITT dataset.||Analysis of covariance (ANCOVA) with factors of treatment,disease severity (\<130mEq/L \[mmol/L\] or ≥130mEq/L \[mmol/L\] at baseline),age (\<65, ≥65 to \<75,and ≥75 years) (factor with 6 Degrees of Freedom), and covariate baseline used to fit primary endpoint using the intent-to-treat (ITT) dataset. Estimated treatment effect and its 95% confidence interval (CI) provided under the model with p-value. A 2-sided alpha (0.05) applied to the primary analysis. Primary analysis based on observed cases (OC).||0.50|-0.03|0.08
71668952|NCT00550459|142854384|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.63||0.21|TWO_SIDED|95.0|-0.12|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|-0.12|0.21
71668953|NCT00550459|142854385|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.27|STANDARD_DEVIATION|0.41||0.02|TWO_SIDED|95.0|0.04|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.51|0.04|0.02
71668954|NCT00550459|142854386|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.83||0.21|TWO_SIDED|95.0|-0.15|0.67||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.67|-0.15|0.21
71751959|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.6||0.156|TWO_SIDED|95.0|-2.2|13.48|||t-test, 2 sided|||t-test used to compare group differences in Cohesiveness at BASELINE||13.48|-2.2|0.156
71751960|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|7.97|STANDARD_ERROR_OF_MEAN|5.89||0.182|TWO_SIDED|95.0|-3.85|19.8|||t-test, 2 sided|||t-test to compare group means on Communication at BASELINE||19.8|-3.85|0.182
71751961|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|8.41|STANDARD_ERROR_OF_MEAN|6.31||0.234|TWO_SIDED|95.0|-5.74|22.57|||t-test, 2 sided|||t-test to compare group differences on Role Clarity at BASELINE||22.57|-5.74|0.234
71751962|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|14.14|STANDARD_ERROR_OF_MEAN|9.63||0.149|TWO_SIDED|95.0|-5.22|33.5|||t-test, 2 sided|||t-test to compare group values on Goals at Baseline||33.5|-5.22|0.149
71751963|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|7.1||0.947|TWO_SIDED|95.0|-14.7|13.8|||t-test, 2 sided|||t-test of differences between groups on Cohesiveness at 6-Months||13.8|-14.7|0.947
71751964|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|8.4||0.87|TWO_SIDED|95.0|-15.6|18.4|||t-test, 2 sided|||t-test of groups differences on Communication at 6 Months||18.4|-15.6|0.870
71751965|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|8.62||0.478|TWO_SIDED|95.0|-11.26|23.63|||t-test, 2 sided|||t-test of group differences on Role Clarity at 6 months||23.63|-11.26|0.478
71751966|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|2.23|STANDARD_ERROR_OF_MEAN|7.71||0.773|TWO_SIDED|95.0|-13.35|17.83|||t-test, 2 sided|||t-test of group differences on Goals at 6 Months||17.83|-13.35|0.773
71751967|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|9.09|STANDARD_ERROR_OF_MEAN|9.8||0.498|TWO_SIDED|95.0|-20.4|38.6|||t-test, 2 sided|||t-test of group differences on Cohesiveness at 1year||38.6|-20.4|0.498
71751968|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|11.4||0.78|TWO_SIDED|95.0|-20.3|26.7|||t-test, 2 sided|||t-test of group differences on Communication at 1 year||26.7|-20.3|0.780
71751969|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|11.46|STANDARD_ERROR_OF_MEAN|12.54||0.474|TWO_SIDED|95.0|-23.19|46.11|||t-test, 2 sided|||t-test of group differences on Role Clarity at 1 year||46.11|-23.19|0.474
71751970|NCT02732600|143007324|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.78||0.267|TWO_SIDED|95.0|-8.21|28.21|||t-test, 2 sided|||t-test of group differences on Goals at 1 year||28.21|-8.21|0.267
71751971|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.38||0.098|TWO_SIDED|95.0|-0.09|1.0|||t-test, 2 sided|||t test comparison across groups on CORE PEER at 6 months||1.00|-0.09|0.098
71751972|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.282|TWO_SIDED|95.0|-0.43|1.43|||t-test, 2 sided|||t-test comparison across groups on COLLABORATION at 6 months||1.43|-0.43|0.282
71751973|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|0.56||0.06|TWO_SIDED|95.0|-0.05|2.29|||t-test, 2 sided|||t-test comparison across groups on PEER SPECIALIST AS LIAISON at 6 months||2.29|-0.05|0.06
71751974|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.86||0.34|TWO_SIDED|95.0|0.07|1.59|||t-test, 2 sided|||t-test comparison across groups on PROVIDES INFO ON SERVICES at 6 months||1.59|0.07|0.34
71751975|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.34|TWO_SIDED|95.0|-0.94|2.62|||t-test, 2 sided|||t-test comparison across groups on Symptoms and Medication at 6-months||2.62|-0.94|0.34
71783643|NCT01447433|143066129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.5|STANDARD_ERROR_OF_MEAN|89.0||0.275|TWO_SIDED|95.0|-81.6|278.7|||t-test, 2 sided|||||278.7|-81.6|0.275
71836042|NCT03526861|143177418|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.7|31.0||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 300 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||31.0|9.7|<0.001
71836043|NCT03526861|143177418|SUPERIORITY|The statistical test was not controlled for multiplicity.|Risk Difference (RD)|21.8|||<|0.001|TWO_SIDED|95.0|10.9|32.7||Based on the primary analysis of the primary estimand 'composite'.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|Subjects with at least 3-point reduction in Adolescent Worst Pruritus NRS were considered responders. Subjects with missing data or who received rescue medication from Week 2 to Week 16 were considered non-responders. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rate between tralokinumab 150 mg Q2W and placebo was tested against the 2-sided alternative that there is a difference.||32.7|10.9|<0.001
71836044|NCT03526861|143177419|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.6||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.6|-8.4|<0.001
71836045|NCT03526861|143177419|SUPERIORITY|The statistical test was not controlled for multiplicity.|Difference of least square means|-5.4|||<|0.001|TWO_SIDED|95.0|-7.9|-3.0||Based on the primary analysis of the primary estimand 'hypothetical'.|Repeated measurements model|||Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0. Data collected after permanent discontinuation of IMP or after use of rescue treatment from Week 2 to Week 16 were not included in the analysis.||-3.0|-7.9|<0.001
71836046|NCT05862870|143177424|OTHER|Frequency count|exact count|20.0|STANDARD_DEVIATION|0.0||0.05|TWO_SIDED|0.0|20.0|20.0|||count|||Frequency count of patients retained in treatment.|Threshold for frequency count|20|20|.05
71836047|NCT04222660|143177468|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71836048|NCT04222660|143177469|OTHER||||||<|0.0025|||||||t-test, 2 sided|||||||<0.0025
71836049|NCT04222660|143177470|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71836050|NCT04222660|143177471|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71836051|NCT04222660|143177472|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71751976|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.64||0.66|TWO_SIDED|95.0|-1.03|1.5|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 6-months||1.50|-1.03|0.66
71836052|NCT04222660|143177473|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71836053|NCT04222660|143177474|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71836054|NCT04222660|143177475|OTHER||||||<|0.0017|||||||t-test, 2 sided|||||||<0.0017
71836055|NCT04222660|143177476|OTHER||||||<|0.0195|||||||t-test, 2 sided|||||||<0.0195
71836056|NCT02520063|143177478|OTHER||||||||||||||||||The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was be estimated at the end of the study along with two-sided 95% exact CIs (Clopper-Pearson intervals).|||
71836057|NCT05338086|143177492|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.51|0.91||Mixed-model for repeated measures (MMRM)|Mixed Models Analysis|MMRM included treatment, with stratification variables as classification factors and baseline BMD as a continuous covariate.||||0.91|-0.51|
71836058|NCT05338086|143177493|EQUIVALENCE|The estimated mean difference in %CfB lumbar spine BMD at Month 12 was presented with 95% CI and equivalence was concluded if this fell within the predefined equivalence margin of \[-1.45%, 1.45%\].|Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.69|0.74|||ANCOVA|ANCOVA included terms for treatment, with stratification variables as classification factors and baseline BMD included as a continuous covariate.|The estimated mean difference in %CfB lumbar spine BMD results was pooled using Rubin's methods and presented with 95% CI.|||0.74|-0.69|
71836059|NCT05338086|143177496|EQUIVALENCE|Equivalence criteria (analysis set mFAS): 95% CI for ratio of geometric LS mean ratios contained in acceptance limits (80.00%, 125.00%).|Ratio of Geometric means|99.91|||||TWO_SIDED|95.0|91.99|108.52|||ANCOVA|ANCOVA model including log-transformed baseline sCTX as a continuous covariate with treatment and stratification variables as fixed effects.||||108.52|91.99|
71836060|NCT05338086|143177497|EQUIVALENCE|Biosimilarity with respect to PD was concluded if the 95% CI for the test (MB09) to reference (EU-Prolia) ratios of the geometric LS means was contained within the \[80.00%, 125.00%\] interval.|Ratio of Geometric means|99.13|||||TWO_SIDED|95.0|96.31|102.02|||ANCOVA|||||102.02|96.31|
71836061|NCT05338086|143177498|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|104.13|||||TWO_SIDED|95.0|98.83|109.71|||ANCOVA|Cmax was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||109.71|98.83|
71836062|NCT05338086|143177499|EQUIVALENCE|Equivalence criteria (on Pharmacokinetic Parameter Analysis Set): the 95% CIs around the geometric LS mean contained in the acceptance limits (80.00%, 125.00%)|LS Geometric Mean Ratio|106.06|||||TWO_SIDED|95.0|99.84|112.66|||ANCOVA|AUC0-6 months was analysed on the log scale by ANCOVA. The model included treatment and stratification variables as fixed effects.||||112.66|99.84|
71836063|NCT02187003|143177622|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7944|TWO_SIDED|95.0|0.77|1.22|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95 percent (%) confidence interval (CI). A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P value.||1.22|0.77|0.7944
71751977|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.61||0.15|TWO_SIDED|95.0|-0.36|2.16|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 6 Months||2.16|-0.36|0.15
71751978|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.39||0.59|TWO_SIDED|95.0|-1.01|0.59|||t-test, 2 sided|||t-test comparison across groups on Leadership at 6-months||0.59|-1.01|0.59
71751979|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.84||0.95|TWO_SIDED|95.0|-1.77|1.68|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 6 months||1.68|-1.77|0.95
71751980|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.55||0.32|TWO_SIDED|95.0|-0.58|1.68|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 6 months||1.68|-0.58|0.32
71751981|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|0.64||0.27|TWO_SIDED|95.0|-0.6|2.04|||t-test, 2 sided|||t-test comparison across both groups on Resources at 6 months||2.04|-0.60|0.27
71751982|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.86||0.93|TWO_SIDED|95.0|-1.71|1.85|||t-test, 2 sided|||t-test comparison across groups on Performance Reviews at 6 months||1.85|-1.71|0.93
71751983|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.32||0.15|TWO_SIDED|95.0|-1.45|-0.005|||t-test, 2 sided|||t-test comparison across groups on CORE PEER at 1 year||-0.005|-1.45|0.15
71751984|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.45||0.04|TWO_SIDED|95.0|-1.7|0.32|||t-test, 2 sided|||t-test comparison across groups on Collaboration at 1 year||0.32|-1.7|0.04
71751985|NCT02732600|143007325|SUPERIORITY||Hazard Ratio, log|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-2.07|0.17|||t-test, 2 sided|||t-test comparison across groups on Peer Specialists as Liaison at 1 year||0.17|-2.07|0.08
71751986|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.26|TWO_SIDED|95.0|-0.58|0.18|||t-test, 2 sided|||t-test comparison across groups on Provides Info on Services at 1 year||0.18|-0.58|0.26
71751987|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.65||0.61|TWO_SIDED|95.0|-4.53|2.83|||t-test, 2 sided|||t-test comparison between groups on Symptoms and Medication at 1 year||2.83|-4.53|0.61
71751988|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.87||0.3|TWO_SIDED|95.0|-2.87|1.01|||t-test, 2 sided|||t-test comparison across groups on Training and Preparation at 1 year||1.01|-2.87|0.30
71751989|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.004|TWO_SIDED|95.0|-2.08|-0.52|||t-test, 2 sided|||t-test comparison across groups on Team Integration and Relationships at 1 year||-0.52|-2.08|0.004
71751990|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.81||0.01|TWO_SIDED|95.0|-4.2|-0.6|||t-test, 2 sided|||t-test comparison across groups on Leadership at 1 year||-0.60|-4.20|0.01
71751991|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.9|TWO_SIDED|95.0|-24.1|23.5|||t-test, 2 sided|||t-test comparison across groups on Fits to Experience at 1 year||23.5|-24.1|0.90
71751992|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.7||0.06|TWO_SIDED|95.0|-3.02|0.12|||t-test, 2 sided|||t-test comparison across groups on Role Clarity at 1 year||0.12|-3.02|0.06
71751993|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.53||0.71|TWO_SIDED|95.0|-0.97|1.37|||t-test, 2 sided|||t-test comparison across groups on Resources at 1 year||1.37|-0.97|0.71
71751994|NCT02732600|143007325|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.63||0.41|TWO_SIDED|95.0|-5.03|2.23|||t-test, 2 sided|||t-test comparison on Performance Reviews at 1 year||2.23|-5.03|0.41
71751995|NCT02732600|143007326|SUPERIORITY||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.17||0.002|TWO_SIDED|95.0|1.29|5.88||not adjusted for multiple comparisons|t-test, 2 sided|||Group Comparison at Baseline||5.88|1.29|0.002
71751996|NCT02732600|143007326|SUPERIORITY||Mean Difference (Final Values)|2.62|STANDARD_ERROR_OF_MEAN|1.6||0.1|TWO_SIDED|95.0|-0.54|5.78|||t-test, 2 sided|||Group Comparison at 6 Months||5.78|-0.54|0.10
71751997|NCT02732600|143007326|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.83||0.77|TWO_SIDED|95.0|-3.06|4.14|||t-test, 2 sided|||Group Comparison at 1 year||4.14|-3.06|0.77
71751998|NCT02732600|143007327|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.56||0.02|TWO_SIDED|95.0|0.56|6.38||p value for 1st year only|t-test, 2 sided|||||6.38|0.56|0.02
71751999|NCT02732600|143007327|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|2.39||0.93|TWO_SIDED|95.0|-4.67|5.04|||t-test, 2 sided|||||5.04|-4.67|0.93
71752000|NCT02732600|143007328|SUPERIORITY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.2||0.0001|TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|p value for 1st year||||1.37|0.68|0.0001
71752001|NCT02732600|143007329|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.26||0.02|TWO_SIDED|95.0|1.46|9.96|||t-test, 2 sided|||||9.96|1.46|0.02
71752002|NCT02732600|143007329|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|2.92||0.38|TWO_SIDED|95.0|-3.14|8.54|||t-test, 2 sided|||||8.54|-3.14|0.38
71752003|NCT02732600|143007330|SUPERIORITY||Mean Difference (Final Values)|-99.4|STANDARD_ERROR_OF_MEAN|41.73||0.027|TWO_SIDED|95.0|-186.2|-12.66|||t-test, 2 sided|||||-12.66|-186.2|0.027
71752004|NCT02732600|143007331|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.18||0.001|TWO_SIDED|95.0|0.28|0.92|||t-test, 2 sided|||||0.92|0.28|0.001
71758536|NCT02205736|143019222|SUPERIORITY|||||||0.005||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0050
71668955|NCT00550459|142854387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_DEVIATION|0.39||0.16|TWO_SIDED|95.0|-0.05|0.3||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.30|-0.05|0.16
71668956|NCT00550459|142854388|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.51|STANDARD_DEVIATION|3.53||0.23|TWO_SIDED|95.0|-4.02|1.0||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||1.00|-4.02|0.23
71668957|NCT00550459|142854389|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83|STANDARD_DEVIATION|3.51||0.18|TWO_SIDED|95.0|-2.04|0.38||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||0.38|-2.04|0.18
71668958|NCT00550459|142854390|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.75|STANDARD_DEVIATION|3.45|<|0.0001|TWO_SIDED|95.0|2.89|6.6||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.||6.60|2.89|<0.0001
71668959|NCT02623725|142854433|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.33|2.06||||||Dengue Virus Serotype 1||2.06|1.33|
71668960|NCT02623725|142854433|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.82|||||TWO_SIDED|95.0|1.43|2.31||||||Dengue Virus Serotype 2||2.31|1.43|
71668961|NCT02623725|142854433|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.04|||||TWO_SIDED|95.0|0.841|1.27||||||Dengue Virus Serotype 3||1.27|0.841|
71668962|NCT02623725|142854433|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \>1/2 for each serotype.|Geometric mean of titer ratio|1.32|||||TWO_SIDED|95.0|1.01|1.74||||||Dengue Virus Serotype 4||1.74|1.01|
71668963|NCT02623725|142854434|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.66|||||TWO_SIDED|95.0|1.34|2.05||||||Dengue Virus Serotype 1||2.05|1.34|
71668964|NCT02623725|142854434|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.89|||||TWO_SIDED|95.0|1.49|2.41||||||Dengue Virus Serotype 2||2.41|1.49|
71668965|NCT02623725|142854434|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.06|||||TWO_SIDED|95.0|0.86|1.3||||||Dengue Virus Serotype 3||1.30|0.860|
71668966|NCT02623725|142854434|SUPERIORITY|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was \>1.|Geometric mean of titer ratio|1.33|||||TWO_SIDED|95.0|1.02|1.73||||||Dengue Virus Serotype 4||1.73|1.02|
71668967|NCT00967330|142854447|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||||||<0.0001
71668968|NCT00967330|142854448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.588||||0.0012|TWO_SIDED|95.0|0.423|0.817|||Chi-squared|||||0.817|0.423|0.0012
71668969|NCT00967330|142854449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.8283|TWO_SIDED|95.0|0.684|1.354|||Chi-squared|||||1.354|0.684|0.8283
71758537|NCT02205736|143019222|SUPERIORITY|||||||0.0423||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0423
71668970|NCT00967330|142854451|SUPERIORITY_OR_OTHER||Difference in response rate|0.06||||0.34745|TWO_SIDED|95.0|-0.02|0.14|||Fisher Exact|||Response rate based on participants with CR at 4 weeks after RT.||0.14|-0.02|0.34745
71668971|NCT00967330|142854451|SUPERIORITY_OR_OTHER||Difference in response rate|0.09||||0.17923|TWO_SIDED|95.0|0.0|0.17|||Fisher Exact|||The response rate based on participants with CR at \>4 weeks after RT.||0.17|0.00|0.17923
71668972|NCT00967330|142854451|SUPERIORITY_OR_OTHER||Difference in response rate|0.0||||1|TWO_SIDED|95.0|-0.08|0.08|||Fisher Exact|||The response rate based on participants with CR at Month 6.||0.08|-0.08|1.00000
71668973|NCT00967330|142854451|SUPERIORITY_OR_OTHER||Difference in response rate|0.25||||0.0021|TWO_SIDED|95.0|0.12|0.38|||Fisher Exact|||Response rate based on participants with CR or PR at 4 weeks after RT.||0.38|0.12|0.00210
71752005|NCT00528957|143007332|NON_INFERIORITY_OR_EQUIVALENCE|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-8.5|||||TWO_SIDED|95.0|-21.5|4.5|||Normal approximation|The difference between the two proportions and its CI were based on normal approximation methods.|Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)|"The statistical hypotheses for the primary endpoint was as follows:~* Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations \< 400 copies/mL at Week 48.~* Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48."||4.5|-21.5|
71752006|NCT00528957|143007333|NON_INFERIORITY|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA \< 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at -15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA \< 400 copies/mL at Week 48.|Difference in percentages between groups|-0.9|||||TWO_SIDED|95.0|-13.7|11.8|||||The difference between the two proportions and its CI were based on normal approximation methods.|||11.8|-13.7|
71752007|NCT02051764|143007378|OTHER|||||||0.2837||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Overall change from baseline between groups. Test compared slopes of cognitively impaired (CI) vs healthy volunteers (HV). As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were the different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.2837
71668974|NCT00967330|142854451|SUPERIORITY_OR_OTHER||Difference in response rate|0.1||||0.18761|TWO_SIDED|95.0|-0.02|0.23|||Fisher Exact|||Response rate based on participants with CR and PR at \>4 weeks after RT.||0.23|-0.02|0.18761
71668975|NCT00967330|142854451|SUPERIORITY_OR_OTHER||Difference in response rate|-0.05||||0.38974|TWO_SIDED|95.0|-0.18|0.07|||Fisher Exact|||Response rate based on participants with CR or PR at Month 6.||0.07|-0.18|0.38974
71752008|NCT02051764|143007378|OTHER|||||||0.9276||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid negative only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.9276
71783644|NCT00036270|143066130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.118|TWO_SIDED|95.0|0.77|1.03|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.~To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis."||1.03|0.77|0.118
71783645|NCT00036270|143066131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.604|TWO_SIDED|95.0|0.88|1.08|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.~To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used."||1.08|0.88|0.604
71783646|NCT00036270|143066132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.951|TWO_SIDED|95.0|0.89|1.14|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.14|0.89|0.951
71813105|NCT03720938|143128560|SUPERIORITY|||||||0.259||||||The outcomes of fat ratio was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the fat ratio at baseline and confounding variable age.|ANCOVA|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.259
71891751|NCT02203149|143305060|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-14.5|10.0|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-14.5|
71668976|NCT00967330|142854453|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|2.1002||||0.4975|TWO_SIDED|95.0|-3.9855|8.186|||ANOVA|||Physical Functioning. Analysis of variance (ANOVA) included all post-baseline data (Months 3 through 21).||8.1860|-3.9855|0.4975
71668977|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4704||||0.76|TWO_SIDED|95.0|-10.9358|7.9951|||ANOVA|||Role Functioning. ANOVA included all post-baseline data (Months 3 through 21).||7.9951|-10.9358|0.7600
71668978|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02278||||0.9949|TWO_SIDED|95.0|-7.035|6.9895|||ANOVA|||Emotional Functioning. ANOVA included all post-baseline data (Months 3 through 21).||6.9895|-7.0350|0.9949
71668979|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8213||||0.6253|TWO_SIDED|95.0|-9.155|5.5125|||ANOVA|||Cognitive Functioning. ANOVA included all post-baseline data (Months 3 through 21).||5.5125|-9.1550|0.6253
71668980|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6126||||0.7219|TWO_SIDED|95.0|-7.2953|10.5205|||ANOVA|||Social Functioning. ANOVA included all post-baseline data (Months 3 through 21).||10.5205|-7.2953|0.7219
71752009|NCT02051764|143007378|OTHER|||||||0.6324||||||Not adjusted for multiple comparisons. No a priori threshold was selected.|ANCOVA|Adjustments included baseline tau deposition, age, time (in years) between imaging, and included an interaction of time and enrolling diagnosis.||Change from baseline between groups for amyloid positive only. Test compared slopes of CI vs HV. As the time between scans varied across subjects, an ANCOVA model was used to estimate slopes in each diagnosis group and test whether they were different at 1 year. The flortaucipir change from baseline was used as the dependent variable in the model.||||0.6324
71752010|NCT03155724|143007404|SUPERIORITY||||||<|0.0001|||||||Exact, binomial, one-sided|||The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing the binomial proportion of 'improved' patients to 3.0% with power of 80% and type 1 error (alpha) of 0.0224. A pre-planned interim analysis at 45 patients required a type 1 error (alpha) of 0.0026 to demonstrate significance.||||<0.0001
71783647|NCT00036270|143066134|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.293|TWO_SIDED|95.0|0.83|1.06|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.||1.06|0.83|0.293
71783648|NCT01964430|143066138|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1824|TWO_SIDED|95.0|0.729|1.063|||Log Rank|Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).|||1.063|0.729|0.1824
71783649|NCT01964430|143066139|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0128|TWO_SIDED|95.0|0.691|0.957|||Log Rank|Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus|||0.957|0.691|0.0128
71783650|NCT02446483|143066147|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|101.32|||||TWO_SIDED|90.0|95.81|107.15||||||||107.15|95.81|
71783651|NCT02446483|143066148|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.71|||||TWO_SIDED|90.0|92.54|105.28||||||Comparison of T- rabeprazole 20 mg and R- rabeprazole 20 mg for AUC0-t.||105.28|92.54|
71783652|NCT02446483|143066148|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.05|||||TWO_SIDED|90.0|91.81|104.71||||||Comparison of Treatment A- rabeprazole 20 mg and Treatment B- rabeprazole 20 mg for AUC0-infinity.||104.71|91.81|
71891752|NCT02203149|143305061|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-6.0|2.8|||Miettinen and Nurminen Method|||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.||2.8|-6.0|
71752011|NCT00321789|143007418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.44|TWO_SIDED|95.0|-3.6|8.3|||Mixed Models Analysis|Model was adjusted for a priori race and cardiovascular disease risk level strata.||||8.3|-3.6|0.44
71752012|NCT00321789|143007419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.03|TWO_SIDED|95.0|-0.23|-0.01|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.01|-0.23|0.03
71752013|NCT00321789|143007420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.02|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.02|-0.29|0.02
71752014|NCT00321789|143007421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.02|TWO_SIDED|95.0|-0.29|-0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||-0.03|-0.29|0.02
71752015|NCT00321789|143007422|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.11|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.03|-0.30|0.11
71752016|NCT00321789|143007423|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.26|TWO_SIDED|95.0|-0.06|0.2|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||0.20|-0.06|0.26
71752017|NCT00321789|143007424|SUPERIORITY_OR_OTHER||incident rate ratio|1.2||||0.06|TWO_SIDED|95.0|1.0|1.5|||generalized estimating equations|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.||||1.5|1.0|0.06
71752018|NCT00321789|143007425|SUPERIORITY_OR_OTHER||incident rate ratio|1.1||||0.37|TWO_SIDED|95.0|0.9|1.4|||generalized estimating equations|Model adjusted for a priori race and cardiovascular disease risk category.||||1.4|0.9|0.37
71752019|NCT00321789|143007426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.11||||0.04|TWO_SIDED|95.0|-4.13|-0.09|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||-0.09|-4.13|0.04
71752020|NCT00321789|143007427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.09|TWO_SIDED|95.0|-1.38|0.1|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.||||0.10|-1.38|0.09
71752021|NCT00321789|143007428|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|Model adjusted for a priori race and cardiovascular disease risk category.||||1.7|0.6|0.87
71752022|NCT02588599|143007431|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t=8.0; df=53||||||<0.0001
71783653|NCT02446483|143066149|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||Wilcoxon's Signed-Rank Test|||||||0.0029
71783654|NCT03736447|143066230|SUPERIORITY||Risk Difference (RD)|67.2|||<|0.0001|TWO_SIDED|95.0|50.0|84.5|||Farrington-Manning test|||||84.5|50.0|<0.0001
71783655|NCT03736447|143066231|SUPERIORITY||Risk Difference (RD)|64.2|||<|0.0001|TWO_SIDED|95.0|47.0|81.4|||Farrington-Manning test|||||81.4|47.0|<0.0001
71783656|NCT03736447|143066232|SUPERIORITY||Risk Difference (RD)|56.7|||<|0.0001|TWO_SIDED|95.0|39.8|73.5|||Farrington-Manning test|||||73.5|39.8|<0.0001
71783657|NCT04666051|143066257|SUPERIORITY|Data from both groups has been collected compared to verify significant statistical difference||||||0.022|||||||Chi-squared|||||||0.022
71891753|NCT01360996|143305064|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<.0001
71752023|NCT03309020|143007433|OTHER|||||||0.802||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses one month after cataract surgery||||0.802
71752024|NCT03309020|143007434|OTHER|||||||0.713||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||Null hypothesis is no difference in grade between survivor statuses three months after cataract surgery||||.713
71752025|NCT03309020|143007435|OTHER||Odds Ratio (OR)|0.1|||||TWO_SIDED|95.0|0.01|0.69|||||Odds of eye with at least 20/40 best corrected visual acuity (BCVA) 12 months after cataract surgery for controls vs. EVD survivors|Null hypothesis is no difference in the proportion of participants with at least 20/40 best corrected visual acuity (BCVA) between survivor statuses||0.69|0.01|
71752026|NCT03309020|143007436|OTHER|||||||0.832||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.832
71752027|NCT03309020|143007437|OTHER|||||||0.995||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||.995
71752028|NCT03309020|143007438|OTHER|||||||0.441||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment and gender (male or female) were included as covariates in the model||||||0.441
71752029|NCT03309020|143007439|OTHER|||||||0.892||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.892
71752030|NCT03309020|143007440|OTHER|||||||0.913||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Age at enrollment, survivor status (EVD survivor/control) included as covariates; within-subject measurement of distinct eyes treated as independent||||||.913
71752031|NCT03309020|143007441|OTHER|||||||0.106||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||.106
71752032|NCT03309020|143007442|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Gender (male/female), survivor status (EVD survivor/control) as covariates; within-subject measurement of distinct eyes treated as independent||||||0.09
71752033|NCT02919761|143007448|OTHER||||||=|0.242||||||At Week 4|One-sample binomial test|||||||=0.242
71752034|NCT02919761|143007448|OTHER||||||<|0.0001||||||At Week 8|One-sample binomial test|||||||<0.0001
71752035|NCT02919761|143007448|OTHER||||||<|0.0001|||||||One-sample binomial test|||||||<0.0001
71752036|NCT02919761|143007449|OTHER||||||=|0.313||||||Comparison at Week 12|Pearson's Chi-square test|||||||=0.313
71752037|NCT02919761|143007449|OTHER||||||=|0.439||||||Comparison at Week 16|Pearson's Chi-square test|||||||=0.439
71752038|NCT02919761|143007449|OTHER||||||=|0.028||||||Comparison at Week 20|Pearson's Chi-square test|||||||=0.028
71752039|NCT02919761|143007449|OTHER||||||=|0.019||||||Comparison at Week 24|Pearson's Chi-square test|||||||=0.019
71752040|NCT03525444|143007468|SUPERIORITY||Least Squares (LS) Mean Difference|13.8|||<|0.0001|TWO_SIDED|95.0|12.1|15.4|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.||15.4|12.1|<0.0001
71752041|NCT03525444|143007469|SUPERIORITY||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|12.7|15.8|||Mixed-effects model for repeated measure|||||15.8|12.7|<0.0001
71752042|NCT03525444|143007470|SUPERIORITY||Rate ratio|0.37|||<|0.0001|TWO_SIDED|95.0|0.25|0.55|||Negative binomial regression model|||||0.55|0.25|<0.0001
71752043|NCT03525444|143007471|SUPERIORITY||LS Mean Difference|-41.8|||<|0.0001|TWO_SIDED|95.0|-44.4|-39.3|||Mixed-effects model for repeated measure|||||-39.3|-44.4|<0.0001
71752044|NCT03525444|143007472|SUPERIORITY||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|17.5|23.0|||Mixed-effects model for repeated measure|||||23.0|17.5|<0.0001
71752045|NCT03525444|143007473|SUPERIORITY||LS Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.85|1.23|||Mixed-effects model for repeated measure|||||1.23|0.85|<0.0001
71752046|NCT03525444|143007474|SUPERIORITY||LS Mean Difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-44.0|-38.5|||Mixed-effects model for repeated measure|||||-38.5|-44.0|<0.0001
71752047|NCT03525444|143007475|SUPERIORITY||LS Mean Difference|20.1|||<|0.0001|TWO_SIDED|95.0|16.9|23.2|||Mixed-effects model for repeated measure|||||23.2|16.9|<0.0001
71752048|NCT03525444|143007477|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|95.0|0.17|0.43||||||||0.43|0.17|
71752049|NCT03525444|143007478|SUPERIORITY||LS Mean Difference|2.9|||||TWO_SIDED|95.0|2.3|3.4||||||||3.4|2.3|
71752050|NCT02973100|143007493|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53|||Mixed Models Analysis|||||-0.53|-1.07|<.001
71752051|NCT02973100|143007493|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.14|-0.6|||Mixed Models Analysis|||||-0.60|-1.14|<0.001
71752052|NCT02973100|143007493|SUPERIORITY||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.24|-0.69|||Mixed Models Analysis|||||-0.69|-1.24|<.001
71752053|NCT02973100|143007494|SUPERIORITY||Odds Ratio (OR)|24.489|||<|0.001|TWO_SIDED|95.0|8.368|71.667|||Regression, Logistic|||||71.667|8.368|<.001
71752054|NCT02973100|143007494|SUPERIORITY||Odds Ratio (OR)|27.906|||<|0.001|TWO_SIDED|95.0|9.238|84.3|||Regression, Logistic|||||84.300|9.238|<.001
71752055|NCT02973100|143007494|SUPERIORITY||Odds Ratio (OR)|21.852|||<|0.001|TWO_SIDED|95.0|7.672|62.242|||Regression, Logistic|||||62.242|7.672|<.001
71752056|NCT02973100|143007495|SUPERIORITY||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-2.02|-0.62|||Mixed Models Analysis|||||-0.62|-2.02|<0.001
71752057|NCT02973100|143007495|SUPERIORITY||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.91|-0.54|||Mixed Models Analysis|||||-0.54|-1.91|<0.001
71752058|NCT02973100|143007495|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.001|TWO_SIDED|95.0|-2.12|-0.72|||Mixed Models Analysis|||||-0.72|-2.12|<0.001
71752059|NCT02973100|143007496|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.025|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||||-0.2|-2.3|0.025
71752060|NCT02973100|143007496|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.4|-1.3|||Mixed Models Analysis|||||-1.3|-3.4|<0.001
71891754|NCT01360996|143305065|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71752061|NCT02973100|143007496|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.7|-1.5|||Mixed Models Analysis|||||-1.5|-3.7|<0.001
71752062|NCT00960622|143007515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.5|<|0.05|TWO_SIDED|95.0|-6.3|11.3|||t-test, 2 sided|||"Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P\<0.05 chosen for statistical significance"||11.3|-6.3|<0.05
71752063|NCT01959503|143007522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon Rank-Sum Test|||||||<0.0001
71752064|NCT01959503|143007523|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.0|||<|0.0001|TWO_SIDED|95.0|4.07|19.89|||Regression, Logistic|||||19.89|4.07|<0.0001
71752065|NCT01959503|143007524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.69|||<|0.0001|TWO_SIDED|95.0|3.27|18.11|||Regression, Logistic|||||18.11|3.27|<0.0001
71752066|NCT01600326|143007530|OTHER|Pair-wise comparison at Time point 1 compared to baseline|||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|See comments on P value||||||<0.0001
71752067|NCT01600326|143007530|SUPERIORITY||||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison||||<0.0001
71752068|NCT01600326|143007531|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>.99
71752069|NCT03224130|143007539|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||||||0.21
71752070|NCT03224130|143007540|SUPERIORITY|||||||0.31|||||||Regression, Linear|||||||0.31
71783658|NCT01651195|143066258|SUPERIORITY|We estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.14990 and α=0.05), we needed 467 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.|||||<|0.05|||||||Fisher Exact||||"Result variables were analyzed according to intention to treat (ITT) principle. Missing data was handled by statistic modeling. Data on symptom diaries were calculated as follows: the incidence and duration of individual infection symptoms and respiratory episodes were analyzed between the intervention groups using time to event analysis (cox model for hazard) and duration analysis (gamma regression model). The results are expressed as a hazard ratio (incidence rate ratio) of symptoms and the mean duration of symptoms (days) with 95% confidence intervals or standard deviations. The sums of respiratory and gastrointestinal symptoms were calculated with gamma regression analysis."|||< 0.05
71783659|NCT01651195|143066259|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
71783660|NCT01651195|143066260|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
71783661|NCT01651195|143066261|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||< 0.05
71891755|NCT01360996|143305066|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71891756|NCT01360996|143305067|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71752071|NCT03224130|143007541|SUPERIORITY|||||||0.24|||||||censored Poisson model|||||||0.24
71752072|NCT03224130|143007542|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
71752073|NCT03224130|143007543|SUPERIORITY|||||||0.5|||||||Regression, Logistic|||||||0.50
71752074|NCT03224130|143007544|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
71752075|NCT03224130|143007545|SUPERIORITY|||||||0.92|||||||Regression, Logistic|||||||0.92
71752076|NCT03284710|143007558|OTHER|||||||0.358||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.358
71752077|NCT03284710|143007558|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||1.000
71752078|NCT03284710|143007558|OTHER|||||||0.361||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.361
71752079|NCT03284710|143007559|OTHER|||||||0.238||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 2||||0.238
71752080|NCT03284710|143007559|OTHER|||||||0.893||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 2||||0.893
71752081|NCT03284710|143007559|OTHER|||||||0.411||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgGAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 2||||0.411
71752082|NCT03284710|143007560|OTHER|||||||1||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||1.000
71752083|NCT03284710|143007560|OTHER|||||||0.044||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.044
71752084|NCT03284710|143007560|OTHER|||||||0.045||||||The threshold for statistical significance was p = 0.05.|Barnard's test|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.045
71752085|NCT03284710|143007561|OTHER|||||||0.215||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 1086C\_D7gp120.avi/293F in Group 1 versus Group 3||||0.215
71752086|NCT03284710|143007561|OTHER|||||||0.683||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to 96ZM651.D11gp120.avi in Group 1 versus Group 3||||0.683
71752087|NCT03284710|143007561|OTHER|||||||0.322||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||IgAAb binding to TV1c8\_D11gp120.avi/293F in Group 1 versus Group 3||||0.322
71752088|NCT01706458|143007643|OTHER|||||||0.906|||||||Log Rank|||||||0.9060
71752089|NCT00072462|143007653|SUPERIORITY||Hazard Ratio (HR)|0.88|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|Univariate||||1.14|0.67|0.33
71752090|NCT00072462|143007653|SUPERIORITY||Hazard Ratio (HR)|0.87|STANDARD_DEVIATION|0.12||0.33|TWO_SIDED|95.0|0.66|1.15|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.15|0.66|0.33
71752091|NCT00072462|143007654|SUPERIORITY||Hazard Ratio (HR)|0.72|STANDARD_DEVIATION|0.12||0.06|TWO_SIDED|95.0|0.52|1.01|||Regression, Cox|Univariate||||1.01|0.52|0.06
71891757|NCT01360996|143305068|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||||||<0.0001
71891758|NCT01360996|143305069|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71752092|NCT00072462|143007654|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.13||0.09|TWO_SIDED|95.0|0.52|1.05|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.05|0.52|0.09
71752093|NCT00072462|143007655|SUPERIORITY||Hazard Ratio (HR)|1.64|STANDARD_DEVIATION|0.54||0.13|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Univariate||||2.84|0.75|0.13
71752094|NCT00072462|143007655|SUPERIORITY||Hazard Ratio (HR)|1.46|STANDARD_DEVIATION|0.5||0.26|TWO_SIDED|95.0|0.75|2.84|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||2.84|0.75|0.26
71752095|NCT00072462|143007656|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.97|TWO_SIDED|95.0|0.21|5.11|||Regression, Cox|Univariate||||5.11|0.21|0.97
71752096|NCT00072462|143007656|SUPERIORITY||Hazard Ratio (HR)|1.08|STANDARD_DEVIATION|0.88||0.93|TWO_SIDED|95.0|0.22|5.36|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||5.36|0.22|0.93
71752097|NCT00072462|143007657|SUPERIORITY||Hazard Ratio (HR)|0.93|STANDARD_DEVIATION|0.17||0.67|TWO_SIDED|95.0|0.65|1.32|||Regression, Cox|Univariate||||1.32|0.65|0.67
71752098|NCT00072462|143007657|SUPERIORITY||Hazard Ratio (HR)|0.85|STANDARD_DEVIATION|0.16||0.38|TWO_SIDED|95.0|0.59|1.22|||Regression, Cox|Covariates included in model: Hormone Replacement Therapy use, Age, BMI, Use of radiotherapy, Extent of margins, Grade(categorical: low, medium, high)||||1.22|0.59|0.38
71668981|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4989||||0.2443|TWO_SIDED|95.0|-2.4046|9.4023|||ANOVA|||Global Health Status /QoL. ANOVA included all post-baseline data (Months 3 through 21).||9.4023|-2.4046|0.2443
71668982|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3449||||0.3287|TWO_SIDED|95.0|-10.0739|3.3841|||ANOVA|||Fatigue. ANOVA included all post-baseline data (Months 3 through 21).||3.3841|-10.0739|0.3287
71668983|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.196||||0.0485|TWO_SIDED|95.0|-8.3635|-0.0285|||ANOVA|||Nausea/Vomiting. ANOVA included all post-baseline data (Months 3 through 21).||-0.02850|-8.3635|0.0485
71752099|NCT02927301|143007664|SUPERIORITY||Other/Percentage|20.3|||<|0.0001|ONE_SIDED|95.0|14.9||||binomial test||||||14.900|<.0001
71752100|NCT02927301|143007665|SUPERIORITY||Risk Difference (RD)|11.41||||0.0358|ONE_SIDED|80.0|5.279||||Fisher Exact||||||5.279|0.0358
71752101|NCT02927301|143007666|SUPERIORITY||Risk Difference (RD)|16.363||||0.0395|ONE_SIDED|80.0|6.509||||Chi-squared||||||6.509|0.0395
71752102|NCT03562195|143007693|SUPERIORITY||Posterior probablity|0.9999|||||||||||Bayesian Dynamic Borrowing|A BDB approach was used in the estimation of primary endpoint in the Chinese participants of this study, with information borrowed from MEA115588.|"Pr (rate ratio \<1 \| data)\>0.999. The 'positive result' is defined as if the posterior probability that the rate ratio is less than 1 is at least 0.95"|||||
71752103|NCT03562195|143007693|SUPERIORITY|The null hypothesis is defined as the rate ratio of events between Mepolizumab 100mg SC versus placebo is less than 1.|Rate Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5|||Negative binomial model|||||0.50|0.24|<0.001
71752104|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.049||||0.7239|TWO_SIDED|90.0|-0.288|0.19|||Mixed Model Repeated Measure|||Week 1||0.190|-0.288|0.7239
71752105|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.018||||0.8351|TWO_SIDED|90.0|-0.127|0.163|||Mixed Model Repeated Measure|||Week 2||0.163|-0.127|0.8351
71752106|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.4541|TWO_SIDED|90.0|-0.287|0.11|||Mixed Model Repeated Measure|||Week 3||0.110|-0.287|0.4541
71752107|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.4148|TWO_SIDED|90.0|-0.272|0.093|||Mixed Model Repeated Measure|||Week 4||0.093|-0.272|0.4148
71752108|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.086||||0.3887|TWO_SIDED|90.0|-0.082|0.254|||Mixed Model Repeated Measure|||Week 5||0.254|-0.082|0.3887
71752109|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.195||||0.2594|TWO_SIDED|90.0|-0.093|0.484|||Mixed Model Repeated Measure|||Week 6||0.484|-0.093|0.2594
71752110|NCT01009060|143007728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.4778|TWO_SIDED|90.0|-0.139|0.344|||Mixed Model Repeated Measure|||Week 7||0.344|-0.139|0.4778
71752111|NCT01009060|143007729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.737||||0.6947|TWO_SIDED|90.0|-3.884|2.409|||ANCOVA|||||2.409|-3.884|0.6947
71752112|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.252||||0.1399|TWO_SIDED|90.0|-0.535|0.03|||Mixed Model Repeated Measure||For Speed of Processing/Simple Reaction Time|||0.030|-0.535|0.1399
71752113|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.179||||0.3992|TWO_SIDED|90.0|-0.176|0.534|||Mixed Model Repeated Measure||For Attention/Vigilance|||0.534|-0.176|0.3992
71752114|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.391||||0.1547|TWO_SIDED|90.0|-0.063|0.845|||Mixed Model Repeated Measure||For Working Memory|||0.845|-0.063|0.1547
71752115|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.279||||0.2531|TWO_SIDED|90.0|-0.127|0.685|||Mixed Model Repeated Measure||For Visual Learning|||0.685|-0.127|0.2531
71752116|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.398||||0.2417|TWO_SIDED|90.0|-0.167|0.963|||Mixed Model Repeated Measure||For Verbal Learning|||0.963|-0.167|0.2417
71752117|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177||||0.2069|TWO_SIDED|90.0|-0.055|0.409|||Mixed Model Repeated Measure||For Reasoning/Problem Solving|||0.409|-0.055|0.2069
71891759|NCT01360996|143305070|SUPERIORITY_OR_OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
71891760|NCT01478958|143305094|SUPERIORITY_OR_OTHER|||||||0.238||||||Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.||To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.||||0.238
71891761|NCT01478958|143305094|SUPERIORITY_OR_OTHER|||||||0.021||||||Effect of the SFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||0.021
71752118|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.8645|TWO_SIDED|90.0|-0.262|0.322|||Mixed Model Repeated Measure||For Social Cognition|||0.322|-0.262|0.8645
71752119|NCT01009060|143007730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.7873|TWO_SIDED|90.0|-0.364|0.503|||Mixed Model Repeated Measure||For Working Memory (Two-Back Memory)|||0.503|-0.364|0.7873
71752120|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.024||||0.0225|TWO_SIDED|90.0|-6.872|-1.175|||ANCOVA||For Speed of Processing|||-1.175|-6.872|0.0225
71752121|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.24||||0.3317|TWO_SIDED|95.0|-6.085|1.605|||ANCOVA||For Attention/Vigilance|||1.605|-6.085|0.3317
71752122|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.038||||0.3243|TWO_SIDED|90.0|-5.482|1.406|||ANCOVA||For Working Memory|||1.406|-5.482|0.3243
71752123|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.746||||0.7497|TWO_SIDED|90.0|-4.667|3.175|||ANCOVA||For Visual Learning|||3.175|-4.667|0.7497
71752124|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.112||||0.1585|TWO_SIDED|90.0|-0.537|6.761|||ANCOVA||For Verbal Learning|||6.761|-0.537|0.1585
71752125|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.972||||0.6582|TWO_SIDED|90.0|-2.709|4.654|||ANCOVA||For Reasoning and Problem Solving|||4.654|-2.709|0.6582
71752126|NCT01009060|143007731|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.338||||0.9092|TWO_SIDED|90.0|-5.316|4.639|||ANCOVA||For Social Cognition|||4.639|-5.316|0.9092
71752127|NCT01009060|143007732|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.024||||0.4406|TWO_SIDED|90.0|-3.237|1.19|||Mixed Model Repeated Measure|||||1.190|-3.237|0.4406
71752128|NCT01009060|143007733|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.876||||0.5197|TWO_SIDED|90.0|-6.743|2.99|||Mixed Model Repeated Measure|||||2.990|-6.743|0.5197
71752129|NCT01009060|143007734|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.824||||0.4637|TWO_SIDED|90.0|-2.334|5.982|||Mixed Model Repeated Measure|||||5.982|-2.334|0.4637
71752130|NCT00119847|143007748|SUPERIORITY||Mean Difference (Net)|-0.04||||0.34|TWO_SIDED|95.0|-0.12|0.04||p\<0.05 required for statistical significance|t-test, 2 sided|||The planned sample size of 300 subjects was chosen to provide 80% power to detect a clinically relevant difference of 0.1 in the change in α1 from baseline to 1 year between the 2 treatment groups on the basis of data from prior studies that indicated that baseline levels of α1 would be 1.0 with a common SD of 0.2.||0.04|-0.12|0.34
71752131|NCT00119847|143007749|SUPERIORITY||Mean Difference (Net)|3.0||||0.45|TWO_SIDED|95.0|-4.8|10.7||p\<0.01 required for statistical significance|t-test, 2 sided|||||10.7|-4.8|0.45
71752132|NCT00119847|143007750|SUPERIORITY||Mean Difference (Net)|2.2||||0.23|TWO_SIDED|95.0|-1.4|5.9||p\<0.01 required for statistical significance|t-test, 2 sided|||||5.9|-1.4|0.23
71752133|NCT00286442|143007751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.32||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.32|-0.68|<0.001
71668984|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.095||||0.0354|TWO_SIDED|95.0|-17.5629|-0.6271|||ANOVA|||Pain. ANOVA included all post-baseline data (Months 3 through 21).||-0.6271|-17.5629|0.0354
71752134|NCT00286442|143007751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.67|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming SD=0.8%, 2-sided test at 0.05 significance level and \>=80% of participants meeting per protocol criteria.||-0.30|-0.67|<0.001
71752135|NCT00286442|143007752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.37|-0.16||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.16|-0.37|<0.001
71752136|NCT00286442|143007752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.19||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.40|<0.001
71752137|NCT00286442|143007753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
71783662|NCT02820753|143066348|SUPERIORITY||Mean Difference (Net)|0.26||||0.04|TWO_SIDED|95.0|0.01|0.51||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment difference = (Text or Portal) - Enhanced Usual Care|||0.51|0.01|0.04
71752138|NCT00286442|143007753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001|TWO_SIDED|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.24|-0.52|<0.001
71752139|NCT00286442|143007754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
71752140|NCT00286442|143007754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.66|-0.34||No multiplicity adjustments|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.66|<0.001
71752141|NCT00286442|143007755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.70|<0.001
71752142|NCT00286442|143007755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
71752143|NCT00286442|143007756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
71752144|NCT00286442|143007756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.69|<0.001
71783663|NCT02820753|143066349|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.15||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||Treatment Difference = (Text or Portal - Enhanced Usual Care|||0.15|-0.08|0.53
71783664|NCT02820753|143066350|SUPERIORITY||Mean Difference (Net)|-0.34||||0.41|TWO_SIDED|95.0|-1.16|0.48||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.48|-1.16|0.41
71783665|NCT02820753|143066351|SUPERIORITY||Mean Difference (Net)|1.83||||0.27|TWO_SIDED|95.0|-1.39|5.06||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment difference = (Text or Portal ) - Enhanced Usual Care|||5.06|-1.39|0.27
71783666|NCT02820753|143066352|SUPERIORITY||Mean Difference (Net)|-0.23||||0.33|TWO_SIDED|95.0|-0.68|0.23||The threshold for significance is p \< 0.05|Mixed Models Analysis||Treatment Difference = (Text or Portal) - Enhanced Usual Care|||0.23|-0.68|0.33
71783667|NCT02139228|143066371|SUPERIORITY_OR_OTHER||Vaccine Group Ratios|0.53|||||TWO_SIDED|95.0|0.36|0.76|||ANOVA|||||0.76|0.36|
71783668|NCT02139228|143066372|SUPERIORITY_OR_OTHER||Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-18.6|-4.2|||Clopper-Pearson|||||-4.2|-18.6|
71783669|NCT00133952|143066401|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.724|TWO_SIDED|95.0|0.15|2.67|||Fisher Exact|||||2.67|0.15|0.724
71783670|NCT00133952|143066402|SUPERIORITY_OR_OTHER||LS Mean difference|-3.3||||0.616|TWO_SIDED|95.0|-16.5|9.8|||Mixed models repeated measures|||||9.8|-16.5|0.616
71783671|NCT00133952|143066403|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||||1.44|0.68|0.971
71783672|NCT00133952|143066405|SUPERIORITY_OR_OTHER||LS Mean difference|0.5||||0.344|TWO_SIDED|95.0|-0.6|1.6|||Mixed models repeated measures|||||1.6|-0.6|0.344
71783673|NCT00133952|143066406|SUPERIORITY_OR_OTHER|||||||0.663||95.0|||||ANCOVA|||||||0.663
71783674|NCT00133952|143066407|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.203|TWO_SIDED|95.0|0.37|1.23|||Cochran-Mantel-Haenszel|||||1.23|0.37|0.203
71783675|NCT00133952|143066409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.749|TWO_SIDED|95.0|0.46|2.92|||Cochran-Mantel-Haenszel|||||2.92|0.46|0.749
71783676|NCT02128113|143066418|SUPERIORITY||LS Mean difference (Net)|26.95||||0.4529|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension (pooled) - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4529
71783677|NCT02128113|143066418|SUPERIORITY||LS Mean difference (Net)|64.31||||0.1276|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.1276
71783678|NCT02128113|143066418|SUPERIORITY||LS Mean difference (Net)|-11.08||||0.7996|TWO_SIDED||||||ANCOVA|Missing data were imputed.|Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.7996
71783679|NCT02128113|143066419|SUPERIORITY||Difference in proportion of patients|-13.55||||0.0647|TWO_SIDED|95.0|-26.75|-0.36|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.36|-26.75|0.0647
71891762|NCT01478958|143305094|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of MUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
71783680|NCT02128113|143066419|SUPERIORITY||Difference in proportion of patients|-15.15||||0.0517|TWO_SIDED|95.0|-28.34|-1.96|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||-1.96|-28.34|0.0517
71783681|NCT02128113|143066420|SUPERIORITY||Difference in proportion of patients|-0.11||||0.9258|TWO_SIDED|95.0|-8.91|8.68|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||8.68|-8.91|0.9258
71783682|NCT02128113|143066420|SUPERIORITY||Difference in proportion of patients|-3.03||||0.6547|TWO_SIDED|95.0|-12.27|6.21|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||6.21|-12.27|0.6547
71783683|NCT02128113|143066421|SUPERIORITY||Difference in proportion of patients|-13.56||||0.0657|TWO_SIDED|95.0|-26.84|-0.28|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||-0.28|-26.84|0.0657
71783684|NCT02128113|143066421|SUPERIORITY|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution|Difference in proportion of patients|-15.15||||0.0526|TWO_SIDED|95.0|-28.42|-1.88|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|||-1.88|-28.42|0.0526
71668985|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2088||||0.3724|TWO_SIDED|95.0|-10.2784|3.8608|||ANOVA|||Dyspnoea. ANOVA included all post-baseline data (Months 3 through 21).||3.8608|-10.2784|0.3724
71668986|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.876||||0.2884|TWO_SIDED|95.0|-13.9002|4.1482|||ANOVA|||Insomnia. ANOVA included all post-baseline data (Months 3 through 21).||4.1482|-13.9002|0.2884
71668987|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.782||||0.4081|TWO_SIDED|95.0|-9.3926|3.8282|||ANOVA|||Appetite loss. ANOVA included all post-baseline data (Months 3 through 21).||3.8282|-9.3926|0.4081
71668988|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9375||||0.275|TWO_SIDED|95.0|-11.0245|3.1495|||ANOVA|||Constipation. ANOVA included all post-baseline data (Months 3 through 21).||3.1495|-11.0245|0.2750
71668989|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1685||||0.0213|TWO_SIDED|95.0|-11.4129|-0.9241|||ANOVA|||Diarrhoea. ANOVA included all post-baseline data (Months 3 through 21).||-0.9241|-11.4129|0.0213
71668990|NCT00967330|142854453|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7295||||0.5201|TWO_SIDED|95.0|-11.0727|5.6137|||ANOVA|||Financial Problems. ANOVA included all post-baseline data (Months 3 through 21).||5.6137|-11.0727|0.5201
71668991|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2699||||0.3613|TWO_SIDED|95.0|-10.2983|3.7585|||ANOVA|||Future uncertainty. ANOVA included all post-baseline data (Months 3 through 21).||3.7585|-10.2983|0.3613
71668992|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1159||||0.6146|TWO_SIDED|95.0|-5.4654|3.2336|||ANOVA|||Visual disorder. ANOVA included all post-baseline data (Months 3 through 21).||3.2336|-5.4654|0.6146
71668993|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1014||||0.686|TWO_SIDED|95.0|-4.2449|6.4477|||ANOVA|||Motor dysfunction. ANOVA included all post-baseline data (Months 3 through 21).||6.4477|-4.2449|0.6860
71668994|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1009||||0.9706|TWO_SIDED|95.0|-5.468|5.2663|||ANOVA|||Communication deficit. ANOVA included all post-baseline data (Months 3 through 21).||5.2663|-5.4680|0.9706
71668995|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.3294||||0.0124|TWO_SIDED|95.0|-14.855|-1.8037|||ANOVA|||Headaches. ANOVA included all post-baseline data (Months 3 through 21).||-1.8037|-14.8550|0.0124
71783685|NCT02128113|143066422|SUPERIORITY||Difference in proportion of patients|0.0||||0.8771|TWO_SIDED|95.0|-10.87|10.87|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 0.5% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||10.87|-10.87|0.8771
71783686|NCT02128113|143066422|SUPERIORITY||Difference in proportion of patients|1.35||||0.8248|TWO_SIDED|95.0|-9.32|12.02|||Cochran-Mantel-Haenszel||Difference is Omaveloxolone Ophthalmic Suspension 1.0% - Vehicle Ophthalmic Solution|Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||12.02|-9.32|0.8248
71783687|NCT02128113|143066423|SUPERIORITY||LS Mean difference (Net)|27.21||||0.4686|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension pooled (0.5% and 1.0%) versus Vehicle Ophthalmic Solution||||0.4686
71783688|NCT02128113|143066423|SUPERIORITY||LS Mean difference (Net)|49.99||||0.2636|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 0.5% versus Vehicle Ophthalmic Solution||||0.2636
71783689|NCT02128113|143066423|SUPERIORITY||LS Mean difference (Net)|-1.74||||0.9691|TWO_SIDED||||||ANCOVA|Missing data were imputed.||Comparison of Omaveloxolone Ophthalmic Suspension 1.0% versus Vehicle Ophthalmic Solution||||0.9691
71668996|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0054||||0.5997|TWO_SIDED|95.0|-4.7654|2.7545|||ANOVA|||Seizures. ANOVA included all post-baseline data (Months 3 through 21).||2.7545|-4.7654|0.5997
71668997|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4399||||0.3458|TWO_SIDED|95.0|-10.6002|3.7204|||ANOVA|||Drowsiness. ANOVA included all post-baseline data (Months 3 through 21).||3.7204|-10.6002|0.3458
71668998|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5908||||0.2383|TWO_SIDED|95.0|-12.2279|3.0464|||ANOVA|||Hair loss. ANOVA included all post-baseline data (Months 3 through 21).||3.0464|-12.2279|0.2383
71668999|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9807||||0.7491|TWO_SIDED|95.0|-5.0373|6.9988|||ANOVA|||Itchy skin. ANOVA included all post-baseline data (Months 3 through 21).||6.9988|-5.0373|0.7491
71669000|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0341||||0.7755|TWO_SIDED|95.0|-8.1508|6.0827|||ANOVA|||Weakness of legs. ANOVA included all post-baseline data (Months 3 through 21).||6.0827|-8.1508|0.7755
71669001|NCT00967330|142854454|SUPERIORITY_OR_OTHER||LS Mean Difference|0.469||||0.841|TWO_SIDED|95.0|-4.1211|5.0591|||ANOVA|||Bladder control. ANOVA included all post-baseline data (Months 3 through 21).||5.0591|-4.1211|0.8410
71669002|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1933||||0.0817|TWO_SIDED|95.0|-0.411|0.02438|||ANOVA|||Orientation to time and place. ANOVA included all post-baseline data (Months 3 through 21).||0.02438|-0.4110|0.0817
71836064|NCT02187003|143177623|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7156|TWO_SIDED|95.0|0.77|1.19|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.19|0.77|0.7156
71752145|NCT00286442|143007757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-20.7|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-6.8|-20.7|<0.001
71836065|NCT02187003|143177624|SUPERIORITY||Mean Difference (Net)|-0.06||||0.852|TWO_SIDED|95.0|-1.27|0.88|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P-value was from analysis of covariance (ANCOVA) model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.88|-1.27|0.8520
71752146|NCT00286442|143007757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||<|0.001|TWO_SIDED|95.0|-18.9|-4.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.|||-4.9|-18.9|<0.001
71836066|NCT02187003|143177625|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8593|TWO_SIDED|95.0|0.82|1.26|||Log Rank|||A Cox proportional hazards regression model with age group and genotype group as stratification covariates was used to estimate the hazard ratio (Placebo/Rivipansel) and the corresponding 95% CI. A stratified log-rank test with age group and genotype group as stratification variables was performed to evaluate P- value.||1.26|0.82|0.8593
71836067|NCT02187003|143177626|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.9332|TWO_SIDED|95.0|-0.13|0.16|||ANCOVA|||The difference in medians (Rivipansel- Placebo) was estimated by the difference of treatment medians from summary statistics. The corresponding 95% CI was estimated by a bootstrap method with stratification for age and genotype groups. P value was from ANCOVA model based on rank-transformed values using age group and genotype group as the stratification covariates.||0.16|-0.13|0.9332
71836068|NCT02187003|143177627|SUPERIORITY||Difference in percentage of participants|-1.17||||0.5349|TWO_SIDED|95.0|-5.19|2.46|||Chan and Zhang|||P values and 95% CI for the difference in percentages were based on the exact method by Chan and Zhang.||2.46|-5.19|0.5349
71836069|NCT02187003|143177634|SUPERIORITY||Risk Difference (RD)|-3.336||||0.302|TWO_SIDED|95.0|-10.024|2.968|||Chan and Zhang|||||2.968|-10.024|0.3020
71669003|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02955||||0.0773|TWO_SIDED|95.0|-0.06234|0.003241|||ANOVA|||Immediate recall. ANOVA included all post-baseline data (Months 3 through 21).||0.003241|-0.06234|0.0773
71783690|NCT00299104|143066440|SUPERIORITY_OR_OTHER|||||||0.0016||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0016
71783691|NCT00299104|143066440|SUPERIORITY_OR_OTHER|||||||0.1824||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status||||0.1824
71783692|NCT00299104|143066440|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0004
71669004|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1429||||0.2608|TWO_SIDED|95.0|-0.1065|0.3924|||ANOVA|||Repetitions required. ANOVA included all post-baseline data (Months 3 through 21).||0.3924|-0.1065|0.2608
71752147|NCT00286442|143007758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-23.9|-9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.5|-23.9|<0.001
71783693|NCT00299104|143066441|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups||||0.0004
71836070|NCT02187003|143177635|SUPERIORITY||Risk Difference (RD)|1.203||||0.5429|TWO_SIDED|95.0|-2.379|5.104|||Chan and Zhang|||||5.104|-2.379|0.5429
71836071|NCT04549168|143177697|SUPERIORITY||LS geometric mean ratio|0.795||||0.0585|TWO_SIDED|95.0|0.627|1.008||Data was analyzed using mixed effect model repeated measurement analysis (MMRM), and the missing values were imputed using multiple imputation and assumed to be missing not at random (MNAR).|MMRM|||||1.008|0.627|0.0585
71836072|NCT04549168|143177698|SUPERIORITY||LSM difference|7.1|||<|0.0001|TWO_SIDED|95.0|4.39|9.81||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.81|4.39|<0.0001
71836073|NCT04549168|143177699|SUPERIORITY||LSM difference|-17.84||||0.0002|TWO_SIDED|95.0|-27.16|-8.51||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-8.51|-27.16|0.0002
71836074|NCT04549168|143177700|SUPERIORITY||LS geometric mean ratio|0.776||||0.0063|TWO_SIDED|95.0|0.647|0.93||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||0.930|0.647|0.0063
71836075|NCT04549168|143177701|SUPERIORITY||LSM difference|4.49||||0.0242|TWO_SIDED|95.0|0.59|8.39||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||8.39|0.59|0.0242
71836076|NCT04549168|143177702|SUPERIORITY||LSM difference|-10.36||||0.1625|TWO_SIDED|95.0|-24.95|4.22||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||4.22|-24.95|0.1625
71836077|NCT04549168|143177703|SUPERIORITY||LS geometric mean ratio|0.815||||0.0515|TWO_SIDED|95.0|0.663|1.001||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||1.001|0.663|0.0515
71783694|NCT00299104|143066441|SUPERIORITY_OR_OTHER|||||||0.1194||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.1194
71752148|NCT00286442|143007758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.001|TWO_SIDED|95.0|-24.1|-9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.6|-24.1|<0.001
71783695|NCT00299104|143066441|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.0001
71783696|NCT00299104|143066442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.3803||95.0|-0.05|0.13||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.13|-0.05|0.3803
71783697|NCT00299104|143066442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.0309||95.0|0.01|0.18||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||0.18|0.01|0.0309
71669005|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|0.003262||||0.9836|TWO_SIDED|95.0|-0.3092|0.3158|||ANOVA|||Calculations. ANOVA included all post-baseline data (Months 3 through 21).||0.3158|-0.3092|0.9836
71752149|NCT00286442|143007759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-24.6|-11.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-11.0|-24.6|<0.001
71752150|NCT00286442|143007759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-24.3|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-24.3|<0.001
71752151|NCT00286442|143007760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||<|0.001|TWO_SIDED|95.0|-28.0|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.2|-28.0|<0.001
71752152|NCT00286442|143007760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-25.6|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.7|-25.6|<0.001
71752153|NCT00286442|143007761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-25.6|-8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.9|-25.6|<0.001
71752154|NCT00286442|143007761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.4|-8.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.6|-25.4|<0.001
71752155|NCT00286442|143007762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-27.4|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.8|-27.4|<0.001
71752156|NCT00286442|143007762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.0|-8.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.3|-25.0|<0.001
71783698|NCT00299104|143066443|SUPERIORITY_OR_OTHER|||||||0.3752||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||0.3752
71783699|NCT00299104|143066443|SUPERIORITY_OR_OTHER|||||||0.0081||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.||||0.0081
71783700|NCT00299104|143066444|SUPERIORITY_OR_OTHER|||||||0.5939||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups.||||0.5939
71783701|NCT00299104|143066444|SUPERIORITY_OR_OTHER|||||||0.5478||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.5478
71783702|NCT00299104|143066444|SUPERIORITY_OR_OTHER|||||||0.3096||95.0||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||0.3096
71669006|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03782||||0.661|TWO_SIDED|95.0|-0.2071|0.1315|||ANOVA|||Short-term verbal memory. ANOVA included all post-baseline data (Months 3 through 21).||0.1315|-0.2071|0.6610
71783703|NCT00299104|143066449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
71783704|NCT00299104|143066449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status||||<0.0001
71783705|NCT00299104|143066459|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.||||<0.0001
71752157|NCT00286442|143007763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.1|||<|0.001|TWO_SIDED|95.0|-26.7|-9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.4|-26.7|<0.001
71752158|NCT00286442|143007763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.001|TWO_SIDED|95.0|-24.2|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.8|-24.2|<0.001
71752159|NCT00286442|143007764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|||<|0.001|TWO_SIDED|95.0|-27.3|-10.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.2|-27.3|<0.001
71752160|NCT00286442|143007764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.9|-8.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.8|-25.9|<0.001
71752161|NCT00286442|143007765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372|||<|0.001|TWO_SIDED|95.0|0.213|0.65||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.650|0.213|<0.001
71752162|NCT00286442|143007765|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.405||||0.002|TWO_SIDED|95.0|0.231|0.708||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.708|0.231|0.002
71783706|NCT00299104|143066459|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
71752163|NCT00286442|143007766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.302||||0.002|TWO_SIDED|95.0|0.143|0.635||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.635|0.143|0.002
71752164|NCT00286442|143007766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.236|||<|0.001|TWO_SIDED|95.0|0.109|0.51|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.510|0.109|<0.001
71752165|NCT00286442|143007767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.634|TWO_SIDED|95.0|-7.4|4.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.5|-7.4|0.634
71783707|NCT00299104|143066465|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.||||<0.0001
71783708|NCT00299104|143066469|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
71783709|NCT00299104|143066469|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.||||<0.0001
71783710|NCT00601458|143066477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.7||||0.005||97.8|-73.6|-8.0||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (pregabalin - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-8.0|-73.6|0.005
71783711|NCT00601458|143066477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-65.4||||0.0001||97.8|-81.7|-34.6||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (naproxen - placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.|||-34.6|-81.7|0.0001
71783712|NCT00601458|143066478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.46||||0.004||95.0|0.183|2.95||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||2.95|0.183|0.004
71783713|NCT00601458|143066478|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.7|||<|0.001||95.0|1.77|6.72||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians|||6.72|1.77|<0.001
71783714|NCT00370032|143066479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.131||95.0|-18.4|2.157|||paired t-test Hommel-Simes|||||2.157|-18.4|0.131
71752166|NCT00286442|143007767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.136|TWO_SIDED|95.0|-10.5|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.4|-10.5|0.136
71752167|NCT00286442|143007768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.274|TWO_SIDED|95.0|-6.9|2.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.0|-6.9|0.274
71752168|NCT00286442|143007768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.046|TWO_SIDED|95.0|-9.1|-0.1||No multiplicity adjustments.|ANCOVA||Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.1|-9.1|0.046
71752169|NCT00286442|143007769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.655|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.655
71752170|NCT00286442|143007769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.645|TWO_SIDED|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-7.4|0.645
71752171|NCT00286442|143007770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.748|TWO_SIDED|95.0|-6.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-6.3|0.748
71783715|NCT00370032|143066479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.11||||0.131||95.0|-21.2|2.997|||paired t-test Hommel-Simes|||||2.997|-21.2|0.131
71783716|NCT03129100|143066488|SUPERIORITY||Odds Ratio (OR)|4.35|||<|0.001|TWO_SIDED|95.0|2.03|9.35|||Regression, Logistic|||||9.35|2.03|<0.001
71783717|NCT03129100|143066489|SUPERIORITY||Odds Ratio (OR)|4.28||||0.003|TWO_SIDED|95.0|1.66|11.03|||Regression, Logistic|||||11.03|1.66|0.003
71783718|NCT03129100|143066489|SUPERIORITY||Odds Ratio (OR)|4.42||||0.001|TWO_SIDED|95.0|1.77|11.02|||Regression, Logistic|||||11.02|1.77|0.001
71783719|NCT03129100|143066491|SUPERIORITY||Odds Ratio (OR)|4.51||||0.001|TWO_SIDED|95.0|1.78|11.41|||Regression, Logistic|||||11.41|1.78|0.001
71783720|NCT03129100|143066491|SUPERIORITY||Odds Ratio (OR)|4.61|||<|0.001|TWO_SIDED|95.0|1.88|11.31|||Regression, Logistic|||||11.31|1.88|<0.001
71783721|NCT03129100|143066492|SUPERIORITY||Odds Ratio (OR)|5.17|||<|0.001|TWO_SIDED|95.0|2.11|12.69|||Regression, Logistic|||||12.69|2.11|<0.001
71783722|NCT03129100|143066492|SUPERIORITY||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|2.2|12.47|||Regression, Logistic|||||12.47|2.20|<0.001
71783723|NCT03129100|143066493|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|1.9|11.17|||Regression, Logistic|||||11.17|1.90|<0.001
71783724|NCT03129100|143066493|SUPERIORITY||Odds Ratio (OR)|3.55||||0.003|TWO_SIDED|95.0|1.56|8.09|||Regression, Logistic|||||8.09|1.56|0.003
71783725|NCT03129100|143066494|SUPERIORITY||Odds Ratio (OR)|4.92|||<|0.001|TWO_SIDED|95.0|2.07|11.72|||Regression, Logistic|||||11.72|2.07|<0.001
71783726|NCT03129100|143066494|SUPERIORITY||Odds Ratio (OR)|3.61||||0.003|TWO_SIDED|95.0|1.57|8.32|||Regression, Logistic|||||8.32|1.57|0.003
71783727|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.1|||ANCOVA|||Patient Global||-1.1|-3.1|<0.001
71783728|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.9|-1.0|||ANCOVA|||Patient Global||-1.0|-2.9|<0.001
71783729|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-3.1|-1.0|||ANCOVA|||Spinal Pain||-1.0|-3.1|<0.001
71783730|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-2.8|-0.8|||ANCOVA|||Spinal Pain||-0.8|-2.8|<0.001
71783731|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-1.55|STANDARD_ERROR_OF_MEAN|0.421|<|0.001|TWO_SIDED|95.0|-2.39|-0.72|||ANCOVA|||BASFI||-0.72|-2.39|<0.001
71783732|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.409|<|0.001|TWO_SIDED|95.0|-2.2|-0.59|||ANCOVA|||BASFI||-0.59|-2.20|<0.001
71783733|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-2.17|STANDARD_ERROR_OF_MEAN|0.448|<|0.001|TWO_SIDED|95.0|-3.05|-1.28|||ANCOVA|||Inflammation||-1.28|-3.05|<0.001
71783734|NCT03129100|143066495|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.433|<|0.001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||Inflammation||-0.95|-2.66|<0.001
71783735|NCT03129100|143066496|SUPERIORITY||Odds Ratio (OR)|5.34|||<|0.001|TWO_SIDED|95.0|2.13|13.35|||Regression, Logistic|||||13.35|2.13|<0.001
71783736|NCT03129100|143066496|SUPERIORITY||Odds Ratio (OR)|4.07||||0.001|TWO_SIDED|95.0|1.75|9.45|||Regression, Logistic|||||9.45|1.75|0.001
71783737|NCT03129100|143066497|SUPERIORITY||LS Mean Difference|-7.858|STANDARD_ERROR_OF_MEAN|1.9586|<|0.001|TWO_SIDED|95.0|-11.729|-3.987|||ANCOVA|||||-3.987|-11.729|<0.001
71783738|NCT03129100|143066497|SUPERIORITY||LS Mean Difference|-5.979|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|-9.655|-2.304|||ANCOVA|||||-2.304|-9.655|0.002
71783739|NCT03129100|143066498|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.104||0.062|TWO_SIDED|95.0|-0.4|0.01|||ANCOVA|||||0.01|-0.40|0.062
71783740|NCT03129100|143066498|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.099||0.018|TWO_SIDED|95.0|-0.43|-0.04|||ANCOVA|||||-0.04|-0.43|0.018
71783741|NCT03129100|143066499|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.335||0.757|TWO_SIDED|95.0|-0.56|0.77|||ANCOVA|||||0.77|-0.56|0.757
71783742|NCT03129100|143066499|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.322||0.67|TWO_SIDED|95.0|-0.77|0.5|||ANCOVA|||||0.50|-0.77|0.670
71669007|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08037||||0.4464|TWO_SIDED|95.0|-0.2875|0.1268|||ANOVA|||Language and construct ability. ANOVA included all post-baseline data (Months 3 through 21).||0.1268|-0.2875|0.4464
71669008|NCT00967330|142854455|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3128||||0.4717|TWO_SIDED|95.0|-1.1658|0.5402|||ANOVA|||Total score. ANOVA included all post-baseline data (Months 3 through 21).||0.5402|-1.1658|0.4717
71669009|NCT00967330|142854456|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.151||||0.2078|TWO_SIDED|95.0|-5.4983|1.1963|||ANOVA|||KPS score. ANOVA included all post-baseline data (Months 3 through 21).||1.1963|-5.4983|0.2078
71669010|NCT01243957|142854459|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.79|||||TWO_SIDED|90.0|1.61|2.0|||ANOVA|||||2.00|1.61|
71669011|NCT01243957|142854460|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.63|||||TWO_SIDED|90.0|1.49|1.79|||ANOVA|||||1.79|1.49|
71669012|NCT01243957|142854461|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5459|TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)|||||0.50|-0.50|0.5459
71669013|NCT01243957|142854462|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.99|1.04|||ANOVA|||Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.||1.04|0.99|
71669014|NCT01243957|142854462|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|1.01|1.06|||ANOVA|||Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.||1.06|1.01|
71669015|NCT01243957|142854463|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||ANOVA|||Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684||1.03|0.97|
71669016|NCT01243957|142854463|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.||1.07|1.00|
71669017|NCT01243957|142854464|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.423|TWO_SIDED|90.0|-3.0|1.42|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.||1.42|-3.00|0.4230
71669018|NCT01243957|142854464|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0||||0.0293|TWO_SIDED|90.0|-6.5|-1.0|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.||-1.00|-6.50|0.0293
71669019|NCT03759392|142854465|SUPERIORITY||Least squares mean difference|-0.447|STANDARD_ERROR_OF_MEAN|0.2931||0.13|TWO_SIDED|95.0|-1.024|0.131|||ANCOVA|Using multiple imputation||||0.131|-1.024|0.13
71752172|NCT00286442|143007770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.432|TWO_SIDED|95.0|-7.7|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.7|0.432
71783743|NCT03129100|143066500|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.338||0.236|TWO_SIDED|95.0|-1.07|0.27|||ANCOVA|||||0.27|-1.07|0.236
71783744|NCT03129100|143066500|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.319||0.373|TWO_SIDED|95.0|-0.92|0.35|||ANCOVA|||||0.35|-0.92|0.373
71783745|NCT03129100|143066501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.459||0.885|TWO_SIDED|95.0|-0.98|0.85|||ANCOVA|||||0.85|-0.98|0.885
71783746|NCT03129100|143066501|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.735|TWO_SIDED|95.0|-0.95|0.68|||ANCOVA|||||0.68|-0.95|0.735
71783747|NCT03129100|143066502|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.501||0.294|TWO_SIDED|95.0|-1.53|0.47|||ANCOVA|||||0.47|-1.53|0.294
71783748|NCT03129100|143066502|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.453||0.164|TWO_SIDED|95.0|-1.54|0.27|||ANCOVA|||||0.27|-1.54|0.164
71783749|NCT03129100|143066503|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.1||0.063|TWO_SIDED|95.0|-4.3|0.1|||ANCOVA|||||0.1|-4.3|0.063
71783750|NCT03129100|143066503|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.02||0.211|TWO_SIDED|95.0|-3.3|0.7|||ANCOVA|||||0.7|-3.3|0.211
71669020|NCT03759392|142854466|SUPERIORITY||Least squares mean difference|-5.388|STANDARD_ERROR_OF_MEAN|2.3937||0.025|TWO_SIDED|95.0|-10.108|-0.0668|||ANCOVA|Using multiple imputation||||-0.0668|-10.108|0.025
71669021|NCT03759392|142854467|SUPERIORITY||Least squares mean difference|0.414|STANDARD_ERROR_OF_MEAN|0.6215||0.51|TWO_SIDED|95.0|-0.81|1.639|||ANCOVA|Using multiple imputation||||1.639|-0.810|0.51
71669022|NCT03759392|142854468|SUPERIORITY||Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.42||0.54|TWO_SIDED|95.0|-0.6|1.1|||Repeated measures mixed model|||||1.1|-0.6|0.54
71669023|NCT04871776|142854472|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.67|1.14|||||How vs Usual Care|We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.14|0.67|
71669024|NCT04871776|142854472|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.81|1.28||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.28|0.81|
71669025|NCT04871776|142854472|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.96|1.51||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.51|0.96|
71669026|NCT04871776|142854473|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.67|1.01||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.01|0.67|
71669027|NCT04871776|142854473|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.23|0.87|
71669028|NCT04871776|142854473|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|1.06|1.49||||||We used generalized estimating equations with a logit link function and binary-distributed errors, adjusting for clinic-day clustering and including clinic as an adjustment variable for all models. This analysis is otherwise unadjusted.||1.49|1.06|
71669029|NCT05620082|142854477|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71669030|NCT05620082|142854478|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71752173|NCT00286442|143007771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.427|TWO_SIDED|95.0|-7.8|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.3|-7.8|0.427
71752174|NCT00286442|143007771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.746|TWO_SIDED|95.0|-4.6|6.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.5|-4.6|0.746
71752175|NCT00286442|143007772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0|-5.0|7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.2|-5.0|0.727
71752176|NCT00286442|143007772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.601||||1.6|TWO_SIDED|95.0|-4.5|7.8||No multiplicity adjustments|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-4.5|1.6
71752177|NCT00286442|143007773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19||||0.066|TWO_SIDED|95.0|-0.15|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-0.15|0.066
71752178|NCT00286442|143007773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.18|TWO_SIDED|95.0|-0.74|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-0.74|0.180
71752179|NCT00286442|143007774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.944|TWO_SIDED|95.0|-5.02|4.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.68|-5.02|0.944
71752180|NCT00286442|143007774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.316|TWO_SIDED|95.0|-7.4|2.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.40|-7.40|0.316
71783751|NCT03129100|143066504|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.9||0.334|TWO_SIDED|95.0|-2.7|0.9|||ANCOVA|||||0.9|-2.7|0.334
71783752|NCT03129100|143066504|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.88||0.168|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|0.168
71752181|NCT00286442|143007775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.901|TWO_SIDED|95.0|-5.42|4.77||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.77|-5.42|0.901
71752182|NCT00286442|143007775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.578|TWO_SIDED|95.0|-6.59|3.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.68|-6.59|0.578
71752183|NCT00286442|143007776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.708|TWO_SIDED|95.0|-2.67|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.93|-2.67|0.708
71752184|NCT00286442|143007776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.601|TWO_SIDED|95.0|-2.44|4.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.21|-2.44|0.601
71752185|NCT00286442|143007777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.398|TWO_SIDED|95.0|-1.48|3.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.72|-1.48|0.398
71783753|NCT03129100|143066506|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.1|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||||0.1|-1.5|0.100
71783754|NCT03129100|143066506|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.047|TWO_SIDED|95.0|-1.5|0.0|||ANCOVA|||||-0.0|-1.5|0.047
71783755|NCT03129100|143066507|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.479||0.068|TWO_SIDED|95.0|-1.83|0.06|||ANCOVA|||||0.06|-1.83|0.068
71783756|NCT03129100|143066507|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.465||0.307|TWO_SIDED|95.0|-1.4|0.44|||ANCOVA|||||0.44|-1.40|0.307
71669031|NCT05620082|142854479|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71669032|NCT05620082|142854480|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Appearance of supplements||||0.10
71669033|NCT05620082|142854480|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparing Smell of supplements between groups||||0.10
71669034|NCT05620082|142854480|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparing Taste of supplements||||0.08
71752186|NCT00286442|143007777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07||||0.425|TWO_SIDED|95.0|-1.56|3.69||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.69|-1.56|0.425
71752187|NCT00286442|143007778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87||||0.018|TWO_SIDED|95.0|0.5|5.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.23|0.50|0.018
71783757|NCT03129100|143066508|SUPERIORITY||LS Mean Difference|2.6021|STANDARD_ERROR_OF_MEAN|1.4684||0.079|TWO_SIDED|95.0|-0.3011|5.5053|||ANCOVA|||||5.5053|-0.3011|0.079
71783758|NCT03129100|143066508|SUPERIORITY||LS Mean Difference|2.4096|STANDARD_ERROR_OF_MEAN|1.3978||0.087|TWO_SIDED|95.0|-0.3541|5.1734|||ANCOVA|||||5.1734|-0.3541|0.087
71783759|NCT03129100|143066509|SUPERIORITY||LS Mean Difference|0.837|STANDARD_ERROR_OF_MEAN|1.1752||0.477|TWO_SIDED|95.0|-1.4864|3.1605|||ANCOVA|||||3.1605|-1.4864|0.477
71783760|NCT03129100|143066509|SUPERIORITY||LS Mean Difference|2.3009|STANDARD_ERROR_OF_MEAN|1.1192||0.042|TWO_SIDED|95.0|0.088|4.5138|||ANCOVA|||||4.5138|0.0880|0.042
71783761|NCT03129100|143066510|SUPERIORITY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.058|TWO_SIDED|95.0|-2.02|0.04|||ANCOVA|||||0.04|-2.02|0.058
71783762|NCT03129100|143066510|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.497||0.147|TWO_SIDED|95.0|-1.71|0.26|||ANCOVA|||||0.26|-1.71|0.147
71783763|NCT03129100|143066511|SUPERIORITY||LS Mean Difference|0.0418|STANDARD_ERROR_OF_MEAN|0.0334||0.213|TWO_SIDED|95.0|-0.0329|0.1164|||ANCOVA|||||0.1164|-0.0329|0.213
71783764|NCT03129100|143066511|SUPERIORITY||LS Mean Difference|0.0388|STANDARD_ERROR_OF_MEAN|0.0319||0.225|TWO_SIDED|95.0|-0.0324|0.1101|||ANCOVA|||||0.1101|-0.0324|0.225
71783765|NCT03129100|143066512|SUPERIORITY||LS Mean Difference|-10.62|STANDARD_ERROR_OF_MEAN|4.383||0.017|TWO_SIDED|95.0|-19.28|-1.95|||ANCOVA|||Percentage of Activity Impairment||-1.95|-19.28|0.017
71783766|NCT03129100|143066512|SUPERIORITY||LS Mean Difference|-7.14|STANDARD_ERROR_OF_MEAN|4.199||0.091|TWO_SIDED|95.0|-15.44|1.16|||ANCOVA|||Percentage of Activity Impairment||1.16|-15.44|0.091
71783767|NCT03129100|143066513|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.66||0.531|TWO_SIDED|95.0|-1.7|0.9|||ANCOVA|||||0.9|-1.7|0.531
71783768|NCT03129100|143066513|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.743|TWO_SIDED|95.0|-1.4|1.0|||ANCOVA|||||1.0|-1.4|0.743
71783769|NCT03845985|143066518|SUPERIORITY|||||||0.838||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.838
71783770|NCT03845985|143066519|SUPERIORITY|||||||0.62||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.620
71783771|NCT03845985|143066520|SUPERIORITY|||||||0.713||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.713
71783772|NCT03845985|143066521|SUPERIORITY|||||||0.509||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.509
71783773|NCT03845985|143066522|SUPERIORITY|||||||0.491||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.491
71783774|NCT03845985|143066523|SUPERIORITY|||||||0.715||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.715
71783775|NCT03845985|143066524|SUPERIORITY|||||||0.665||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.665
71783776|NCT03845985|143066525|SUPERIORITY|||||||0.875||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.875
71783777|NCT03845985|143066526|SUPERIORITY|||||||0.61||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Risk and Aggression/Liquid Courage/Sociability Subscale||||.610
71669035|NCT05620082|142854480|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Comparing Sweetness of supplements||||0.70
71783778|NCT03845985|143066526|SUPERIORITY|||||||0.658||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Self-Perception/Cognitive and Behavioral Impairment Subscale||||.658
71783779|NCT03845985|143066526|SUPERIORITY|||||||1||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Sexuality Subscale||||1.000
71783780|NCT03845985|143066526|SUPERIORITY|||||||0.007||||||Analysis was significantly underpowered.|t-test, 2 sided|||Comparison of the Tension Reduction Subscale||||.007
71783781|NCT03845985|143066527|SUPERIORITY|||||||0.407||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.407
71783782|NCT03845985|143066528|SUPERIORITY|||||||0.893||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.893
71783783|NCT03845985|143066529|SUPERIORITY|||||||0.709||||||Analysis was significantly underpowered.|t-test, 2 sided|||||||.709
71783784|NCT03334539|143066535|SUPERIORITY||Least Squares (LS) Mean Difference|0.11||||0.3378|TWO_SIDED|95.0|-0.12|0.34||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.34|-0.12|0.3378
71669036|NCT05620082|142854480|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparing Texture of supplements||||0.02
71669037|NCT05620082|142854480|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing Thickness of supplements||||0.45
71669038|NCT05620082|142854480|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Comparing Aftertaste of supplements||||0.25
71783785|NCT03334539|143066535|SUPERIORITY||LS Mean Difference|0.12||||0.2883|TWO_SIDED|95.0|-0.1|0.35||P-value was calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.35|-0.10|0.2883
71783786|NCT03334539|143066535|OTHER||LS Mean Difference|0.01||||0.9293|TWO_SIDED|95.0|-0.22|0.24||P-value calculated using a model with treatment, baseline score, and site as covariates|ANCOVA|||||0.24|-0.22|0.9293
71783787|NCT03334539|143066536|SUPERIORITY||LS Mean Difference|-0.3||||0.1473|TWO_SIDED|95.0|-0.7|0.1||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.1|-0.7|0.1473
71783788|NCT03334539|143066536|SUPERIORITY||LS Mean Difference|-0.3||||0.2321|TWO_SIDED|95.0|-0.7|0.2||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.2|-0.7|0.2321
71783789|NCT03334539|143066536|OTHER||LS Mean Difference|0.0||||0.8217|TWO_SIDED|95.0|-0.4|0.5||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.5|-0.4|0.8217
71836078|NCT04549168|143177704|SUPERIORITY||LSM difference|7.74|||<|0.0001|TWO_SIDED|95.0|5.61|9.86||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||9.86|5.61|<0.0001
71752188|NCT00286442|143007778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.067|TWO_SIDED|95.0|-0.15|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.60|-0.15|0.067
71752189|NCT00286442|143007779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036||||0.011|TWO_SIDED|95.0|-0.064|-0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.009|-0.064|0.011
71752190|NCT00286442|143007779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|||<|0.001|TWO_SIDED|95.0|-0.075|-0.019||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.019|-0.075|<0.001
71752191|NCT00286442|143007780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||<|0.001|TWO_SIDED|95.0|-0.07|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.021|-0.070|<0.001
71752192|NCT00286442|143007780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.004|TWO_SIDED|95.0|-0.062|-0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.012|-0.062|0.004
71752193|NCT00286442|143007781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.007|TWO_SIDED|95.0|-0.068|-0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.011|-0.068|0.007
71752194|NCT00286442|143007781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.011|TWO_SIDED|95.0|-0.066|-0.008||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm|||-0.008|-0.066|0.011
71783790|NCT04974697|143066603|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for myope.|Least-square Mean|58.1|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|50.9|65.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 22 subjects were required to test superiority for myope.||65.4|50.9|
71783791|NCT04974697|143066603|SUPERIORITY|The superiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points for hyperope.|Least-square Mean|55.0|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|47.2|62.8|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated using a 2-sided one sample means t-test with a family wise type I error rate of 5% and at least 80% statistical power, that 18 subjects were required to test superiority for hyperope.||62.8|47.2|
71752195|NCT00286442|143007782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|||<|0.001|TWO_SIDED|95.0|-0.08|-0.024||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.024|-0.080|<0.001
71752196|NCT00286442|143007782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.003|TWO_SIDED|95.0|-0.072|-0.015||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.015|-0.072|0.003
71752197|NCT00286442|143007783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046||||0.078|TWO_SIDED|95.0|-0.097|0.005||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.005|-0.097|0.078
71752198|NCT00286442|143007783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.86|TWO_SIDED|95.0|-0.056|0.047||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.047|-0.056|0.860
71836079|NCT04549168|143177705|SUPERIORITY||LSM difference|-21.25|||<|0.0001|TWO_SIDED|95.0|-28.15|-14.35||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM|||||-14.35|-28.15|<0.0001
71836080|NCT04549168|143177707|SUPERIORITY||LSM difference|-2.85|STANDARD_ERROR_OF_MEAN|0.811||0.0006|TWO_SIDED|95.0|-4.45|-1.25||Based on Analysis of Covariance (ANCOVA) model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-1.25|-4.45|0.0006
71669039|NCT05620082|142854480|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Feeling in mouth' of supplements||||0.45
71669040|NCT05620082|142854480|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparing 'Future choice' of supplements||||0.06
71669041|NCT05620082|142854481|SUPERIORITY|||||||0.004||||||Pairwise comparisons with Bonferroni correction revealed a significant increase in total daily energy intake from baseline to porridge timepoints (p\<0.001).|Related samples Friedman's Two-Way ANOVA|||||||0.004
71669042|NCT01402570|142854509|SUPERIORITY_OR_OTHER||REML|0.17||||0.66|TWO_SIDED|95.0|-0.67|0.95||Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.95|-0.67|0.66
71669043|NCT01402570|142854510|SUPERIORITY_OR_OTHER||REML|0.0||||0.44|TWO_SIDED|95.0|-0.01|0.02||Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.02|-0.01|0.44
71669044|NCT01402570|142854511|SUPERIORITY_OR_OTHER||REML|145.54||||0.35|TWO_SIDED|95.0|-178.93|470.02||Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||470.02|-178.93|0.35
71669045|NCT01402570|142854512|SUPERIORITY_OR_OTHER||REML|-1.05||||0.07|TWO_SIDED|95.0|-2.21|0.1||Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.||0.10|-2.21|0.07
71669046|NCT03514459|142854513|SUPERIORITY||Prevalence ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.54|2.2|||Poisson regression|Robust standard errors||||2.20|1.54|<0.001
71669047|NCT04179838|142854522|SUPERIORITY|||||||0.001||||||Corrected for multiple comparisons in piriform cortex|t-test, 1 sided|||Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.||||0.001
71669048|NCT04179838|142854523|SUPERIORITY|||||||0.021|||||||t-test, 1 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.021
71669049|NCT04179838|142854524|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.63
71783792|NCT04974697|143066604|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold 0.00 logMAR for Distance.|Least-square Mean|-0.129|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.167|-0.091|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 42 subjects were required to test superiority for distance (4m).||-0.091|-0.167|
71783793|NCT04974697|143066604|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate.|Least-square Mean|-0.046|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.084|-0.008|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 7 subjects were required to test superiority for intermediate (64 cm).||-0.008|-0.084|
71813106|NCT03720938|143128560|SUPERIORITY|||||||0.22||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.220
71669050|NCT04179838|142854525|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.08
71669051|NCT04179838|142854526|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.28
71669052|NCT04179838|142854527|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.50
71669053|NCT04179838|142854528|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.||||0.58
71669054|NCT00080912|142854534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.|Risk Difference (RD)|4.0||||0.03|ONE_SIDED|95.0||9.2||p-value is for one-sided non-inferiority test|Cochran-Mantel-Haenszel||The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary|||9.2||0.03
71752199|NCT00286442|143007784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053||||0.048|TWO_SIDED|95.0|-0.106|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.001|-0.106|0.048
71752200|NCT00286442|143007784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.889|TWO_SIDED|95.0|-0.057|0.05||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.050|-0.057|0.889
71752201|NCT00286442|143007785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.336||||0.031|TWO_SIDED|95.0|0.03|0.642||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.642|0.030|0.031
71752202|NCT00286442|143007785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304||||0.051|TWO_SIDED|95.0|-0.002|0.611||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.611|-0.002|0.051
71752203|NCT00286442|143007786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.563|TWO_SIDED|95.0|-0.209|0.384||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.384|-0.209|0.563
71752204|NCT00286442|143007786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.467|TWO_SIDED|95.0|-0.188|0.41||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.410|-0.188|0.467
71752205|NCT00286442|143007787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.243|TWO_SIDED|95.0|-0.127|0.501||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.501|-0.127|0.243
71752206|NCT00286442|143007787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279||||0.083|TWO_SIDED|95.0|-0.037|0.595||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.595|-0.037|0.083
71752207|NCT00286442|143007788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155||||0.321|TWO_SIDED|95.0|-0.152|0.463||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.463|-0.152|0.321
71752208|NCT00286442|143007788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.089|TWO_SIDED|95.0|-0.041|0.577||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.577|-0.041|0.089
71752209|NCT00286442|143007789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144||||0.305|TWO_SIDED|95.0|-0.132|0.42||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.420|-0.132|0.305
71752210|NCT00286442|143007789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191||||0.177|TWO_SIDED|95.0|-0.086|0.468||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.468|-0.086|0.177
71752211|NCT00286442|143007790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394||||0.007|TWO_SIDED|95.0|0.107|0.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.680|0.107|0.007
71752212|NCT00286442|143007790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263||||0.074|TWO_SIDED|95.0|-0.025|0.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.550|-0.025|0.074
71752213|NCT00286442|143007791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.15|||<|0.001|TWO_SIDED|95.0|2.117|17.864||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||17.864|2.117|<0.001
71783794|NCT04974697|143066604|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near.|Least-square Mean|0.067|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|0.029|0.105|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||It was calculated by using a 2-sided one sample mean t-test with a family wise type I error rate of 5% and at least 80% statistical power , 36 subjects were required to test superiority for near (40 cm).||0.105|0.029|
71669055|NCT02099786|142854535|SUPERIORITY||Odds Ratio (OR)|2.2||||0.27|TWO_SIDED|95.0|0.55|8.8|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with ASHA-significant threshold shifts between treatment arms.||8.8|.55|.27
71669056|NCT02099786|142854535|SUPERIORITY||Odds Ratio (OR)|1.4||||0.67|TWO_SIDED|95.0|0.3|5.9|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with CTCAE grade 1 or greater hearing loss between treatment arms.||5.9|.3|.67
71669057|NCT02099786|142854536|SUPERIORITY||Odds Ratio (OR)|0.92||||0.88|TWO_SIDED|95.0|0.29|2.9|||Regression, Logistic|||Null hypothesis is no difference in audiology clinic use between treatment arms.||2.9|.29|.88
71669058|NCT02099786|142854537|NON_INFERIORITY|We require a non-inferiority margin of no more than 1.1 mortality odds among COMP-VA patients relative to Usual Care patients. This means that the upper 95% confidence bound for the fitted odds ratio must be less than 1.1 to reject the null hypothesis that COMP-VA induces extra mortality risk.|Odds Ratio (OR)|1.9|||||ONE_SIDED|||||||||||||
71669059|NCT02099786|142854538|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance is .05|t-test, 2 sided|||||||.72
71783795|NCT04974697|143066605|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|8.4|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|3.1|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|3.1|
71783796|NCT04974697|143066605|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|5.0|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-1.2|11.2|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.2|-1.2|
71669060|NCT00818766|142854544|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.3||||0.26||95.0|-11.3|2.7|||Fisher Exact|||||2.7|-11.3|.26
71669061|NCT00818766|142854545|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.93||||0.77|TWO_SIDED|95.0|-6.1|4.3|||Fisher Exact|||||4.3|-6.1|0.77
71669062|NCT00818766|142854546|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.21|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|.21
71752214|NCT00286442|143007791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.322||||0.002|TWO_SIDED|95.0|1.82|15.564||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||15.564|1.820|0.002
71752215|NCT00286442|143007792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.092|||<|0.001|TWO_SIDED|95.0|3.271|11.345||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||11.345|3.271|<0.001
71752216|NCT00286442|143007792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.451|||<|0.001|TWO_SIDED|95.0|2.388|8.296||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.296|2.388|<0.001
71752217|NCT00286442|143007793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.238|||<|0.001|TWO_SIDED|95.0|2.327|7.717||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.717|2.327|<0.001
71752218|NCT00286442|143007793|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.293|||<|0.001|TWO_SIDED|95.0|1.814|5.979|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.979|1.814|<0.001
71836081|NCT04549168|143177708|SUPERIORITY||LSM difference|-1.74|STANDARD_ERROR_OF_MEAN|0.488||0.0005|TWO_SIDED|95.0|-2.7|-0.78||Based on ANCOVA model with factors of age group, site, treatment, and the baseline ISI as a covariate.|ANCOVA|||||-0.78|-2.70|0.0005
71669063|NCT00818766|142854547|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
71669064|NCT00818766|142854549|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
71669065|NCT00818766|142854550|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|||||||.25
71669066|NCT01996241|142854558|OTHER|Odds ratio (95% CI), p-value for all the outcomes.|Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.7|1.38||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.38|0.7|0.98
71669067|NCT01996241|142854559|OTHER||Odds Ratio (OR)|1.0||||0.98|TWO_SIDED|95.0|0.7|1.4||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.4|0.7|0.98
71669068|NCT01996241|142854560|OTHER||Odds Ratio (OR)|1.32||||0.331|TWO_SIDED|95.0|0.2|2.31||Adjusted for village strata and cluster, village type, caste, household literacy status, stratum using individual-level data and poor learning environment at school, school dropout, and marriage (in the form of cluster-level summaries).|Regression, Logistic|Mixed-effects||||2.31|0.2|0.331
71669069|NCT01996241|142854561|OTHER||Odds Ratio (OR)|0.83||||0.26|TWO_SIDED|95.0|0.6|1.15||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.15|0.6|0.26
71669070|NCT01996241|142854562|OTHER||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.7|1.55||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.55|0.7|0.79
71669071|NCT01996241|142854563|OTHER||Odds Ratio (OR)|0.83||||0.45|TWO_SIDED|95.0|0.5|1.34||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects||||1.34|0.5|0.45
71752219|NCT00286442|143007794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.103|||<|0.001|TWO_SIDED|95.0|2.428|6.934||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.934|2.428|<0.001
71752220|NCT00286442|143007794|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.314|||<|0.001|TWO_SIDED|95.0|2.545|7.312||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||7.312|2.545|<0.001
71752221|NCT00286442|143007795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.601|||<|0.001|TWO_SIDED|95.0|2.554|12.282||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.282|2.554|<0.001
71752222|NCT00286442|143007795|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.793|||<|0.001|TWO_SIDED|95.0|2.645|12.684||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||12.684|2.645|<0.001
71752223|NCT00286442|143007796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.449||||0.085|TWO_SIDED|95.0|0.883|6.797||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||6.797|0.883|0.085
71783797|NCT04974697|143066606|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|6.9|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|0.0|13.7|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||13.7|0.0|
71669072|NCT01111318|142854584|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.15|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|98.89|153.36|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||153.36|98.89|
71669073|NCT01111318|142854584|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|146.97|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|118.02|183.02|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||183.02|118.02|
71669074|NCT01111318|142854584|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|174.7|STANDARD_DEVIATION|29.0|||TWO_SIDED|90.0|140.29|217.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||217.55|140.29|
71669075|NCT01111318|142854585|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|103.81|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|82.29|130.95|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy||130.95|82.29|
71669076|NCT01111318|142854585|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.31|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|97.74|155.55|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy||155.55|97.74|
71669077|NCT01111318|142854585|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio|148.41|STANDARD_DEVIATION|30.7|||TWO_SIDED|90.0|117.65|187.23|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to hepatic impairment status).|Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy||187.23|117.65|
71669078|NCT02091856|142854599|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre \& post||It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.||||<0.001
71669079|NCT02091856|142854600|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).||||||>0.05
71669080|NCT02091856|142854601|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.01
71669081|NCT02091856|142854602|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|ANOVA|||||||<0.001
71669082|NCT02091856|142854603|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The a priori threshold for statistical significance was set at .05|t-test, 1 sided|||||||<0.01
71752224|NCT00286442|143007796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.958||||0.034|TWO_SIDED|95.0|1.087|8.046||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||8.046|1.087|0.034
71752225|NCT00286442|143007797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.404||||0.639|TWO_SIDED|95.0|0.34|5.803||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||5.803|0.340|0.639
71752226|NCT00286442|143007797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.956|TWO_SIDED|95.0|0.218|4.223||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \>1.0 indicates higher incidence of response compared to placebo.|||4.223|0.218|0.956
71752227|NCT00286442|143007798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.439|TWO_SIDED|95.0|-0.63|0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.27|-0.63|0.439
71752228|NCT00286442|143007798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.075|TWO_SIDED|95.0|-0.86|0.04||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.04|-0.86|0.075
71752229|NCT00286442|143007799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.305|TWO_SIDED|95.0|-0.26|0.83||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.83|-0.26|0.305
71752230|NCT00286442|143007799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.788|TWO_SIDED|95.0|-0.63|0.47||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.47|-0.63|0.788
71752231|NCT00286442|143007800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.93|TWO_SIDED|95.0|-0.58|0.63||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.63|-0.58|0.930
71752232|NCT00286442|143007800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.559|TWO_SIDED|95.0|-0.79|0.43||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.43|-0.79|0.559
71752233|NCT00286442|143007801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.66|0.66||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.66|-0.66|0.996
71669083|NCT02002221|142854656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.08|-0.73|||ANCOVA|||H0: δ vildagliptin 50 mg bid = δ placebo versus H1: δ Vildagliptin 50 mg bid \< δ placebo,||-0.73|-1.08|< 0.001
71752234|NCT00286442|143007801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.407|TWO_SIDED|95.0|-0.94|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.38|-0.94|0.407
71752235|NCT02542865|143007848|SUPERIORITY||Mean Difference (Net)|-6.0|STANDARD_ERROR_OF_MEAN|1.56||0.0628|TWO_SIDED|95.0|-12.7|0.8|||ANCOVA|Analysis of variance(ANCOVA):cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group (fortified malt based food plus dietary counselling) minus Control Group (dietary counselling only).|||0.8|-12.7|0.0628
71752236|NCT02542865|143007848|SUPERIORITY||Mean Difference (Net)|-4.9||||0.039|||||||ANCOVA|ANCOVA:cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group minus Control Group. The corresponding CI is not presented as there is no direct back-transformation.|Since the distribution of the data was found to be more skewed with more zero counts than was anticipated at the time the trial was designed, an additional analysis of log (+1)-transformed data was performed.||||0.0390
71752237|NCT04571944|143007881|SUPERIORITY||Difference in % vs Placebo|-8.7||||0.129|TWO_SIDED|95.0|-20.1|2.6|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.6|-20.1|0.129
71752238|NCT04571944|143007882|OTHER||Difference in % vs. Placebo|0.8|||||TWO_SIDED|95.0|-9.3|11.0||||||||11.0|-9.3|
71752239|NCT04571944|143007883|OTHER||Difference in % vs. Placebo|0.0|||||TWO_SIDED|95.0|-5.1|5.2||||||||5.2|-5.1|
71752240|NCT04571944|143007884|SUPERIORITY||Difference vs. Placebo|-0.5||||0.485|TWO_SIDED|95.0|-2.0|1.0||Based on aligned rank test.|Hodges-Lehmann method|||||1.0|-2.0|0.485
71783798|NCT04974697|143066606|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|3.3|STANDARD_ERROR_OF_MEAN|4.03|||TWO_SIDED|95.0|-4.7|11.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||11.3|-4.7|
71783799|NCT04974697|143066607|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for myope.|Least-square Mean|11.2|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|5.0|17.4|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.4|5.0|
71783800|NCT04974697|143066607|NON_INFERIORITY|The non-inferiority of the test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold -5 points for hyperope.|Least-square Mean|10.0|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|2.8|17.3|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||The study was only powered for the primary endpoint.||17.3|2.8|
71783801|NCT03302234|143066639|OTHER||Hazard Ratio (HR)|1.08||||0.74156|TWO_SIDED|95.0|0.85|1.37||One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|||1.37|0.85|0.74156
71783802|NCT03302234|143066640|OTHER||Hazard Ratio (HR)|1.06||||0.7172|TWO_SIDED|95.0|0.86|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||1.30|0.86|0.71720
71783803|NCT03302234|143066641|OTHER||Difference in percentage|-0.1||||0.50644|TWO_SIDED|95.0|-8.2|8.1|||Miettinen & Nurminen method|One-sided p-value for testing|Based on Miettinen \& Nurminen method stratified by ECOG, geographic region of the enrolling site and predominant tumor history.|||8.1|-8.2|0.50644
71783804|NCT03302234|143066643|OTHER||Hazard Ratio (HR)|0.9815||||0.9112|TWO_SIDED|95.0|0.7386|1.3042|||Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.|||1.3042|0.7386|0.9112
71669084|NCT01518322|142854661|SUPERIORITY_OR_OTHER||Kappa Statistics|0.049|||||TWO_SIDED|95.0|-0.0895|0.1875||||||Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.||0.1875|-0.0895|
71752241|NCT04571944|143007885|SUPERIORITY||Difference in % vs. Placebo|-8.6||||0.136|TWO_SIDED|95.0|-20.2|2.8|||Miettinen and Nurminen method|Analysis was stratified by hospitalization reason (acute disease, elective surgery) and age category (\<75 years, ≥75 years).||||2.8|-20.2|0.136
71783805|NCT03302234|143066646|OTHER||Difference in LS Means|-0.42||||0.8151|TWO_SIDED|95.0|-3.96|3.12|||cLDA Model|Constrained longitudinal data analysis (cLDA) Model|Based on a cLDA model with PRO scores as response variable, with covariates for treatment by time interaction, and stratification factors (ECOG, geographic region of the enrolling site, \& predominant tumor histology) as covariates.|||3.12|-3.96|0.8151
71783806|NCT02795832|143066647|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|12.441||0.5016|TWO_SIDED|90.0|-21.24|21.34||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Observed case||21.34|-21.24|0.5016
71783807|NCT02795832|143066647|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-3.01|STANDARD_ERROR_OF_MEAN|12.964||0.4082|TWO_SIDED|90.0|-24.39|18.36||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Multiple imputations||18.36|-24.39|0.4082
71783808|NCT02795832|143066647|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-18.27|STANDARD_ERROR_OF_MEAN|13.138||0.0878|TWO_SIDED|90.0|-40.65|4.11||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Last observation carried forward||4.11|-40.65|0.0878
71783809|NCT02795832|143066647|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-37.6|STANDARD_ERROR_OF_MEAN|18.748||0.0275|TWO_SIDED|90.0|-69.53|-5.66||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Worst case imputation||-5.66|-69.53|0.0275
71783810|NCT02795832|143066648|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-11.72||||0.1284|TWO_SIDED|90.0|-28.85|5.51||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 5||5.51|-28.85|0.1284
71783811|NCT02795832|143066648|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-5.95||||0.2765|TWO_SIDED|90.0|-22.85|10.95||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 8||10.95|-22.85|0.2765
71669085|NCT03787134|142854819|SUPERIORITY|||||||0.335|||||||t-test, 2 sided|||cued memory item reconstruction - test of reconstruction strength against 0||||.335
71669086|NCT03787134|142854819|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|||uncued memory item reconstruction - test of reconstruction strength against 0||||.016
71677100|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-18.81|-7.32||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-7.32|-18.81|<0.0001
71752242|NCT04913610|143007889|OTHER||||||=|0.036|||||||Mann-Whitney U test|The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.036
71752243|NCT04913610|143007889|OTHER||||||=|0.53||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.530
71783812|NCT02795832|143066648|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-6.01||||0.2765|TWO_SIDED|90.0|-23.08|11.06||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< the placebo LS mean.|ANCOVA|||Day 10||11.06|-23.08|0.2765
71783813|NCT02795832|143066648|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05||||0.5016|TWO_SIDED|90.0|-21.24|21.34|||ANCOVA|||Day 15||21.34|-21.24|0.5016
71752244|NCT04913610|143007889|OTHER||||||=|0.852||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.852
71752245|NCT04913610|143007889|OTHER||||||=|0.366||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.366
71752246|NCT04913610|143007890|OTHER||||||=|0.869||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.869
71752247|NCT04913610|143007890|OTHER||||||=|0.973||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.973
71752248|NCT04913610|143007890|OTHER||||||=|0.744||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.744
71752249|NCT04913610|143007890|OTHER||||||=|0.794||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the percentage per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.794
71752250|NCT04913610|143007891|OTHER||||||=|0.559||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.559
71783814|NCT02795832|143066649|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|1.55||||0.4789|TWO_SIDED|90.0|0.28|10.75||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI 50||10.75|0.28|0.4789
71783815|NCT02795832|143066649|SUPERIORITY|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|2.0||||0.3|TWO_SIDED|90.0|0.24|999.0||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|ANCOVA|||EASI-75||999|0.24|0.3000
71783816|NCT02795832|143066650|SUPERIORITY||Odds Ratio (OR)|0.45||||0.5|TWO_SIDED|95.0|0.01|19.2||Results for the ZPL-5212372 and placebo groups are estimated adjusted LS means from the fitted model.|Shapiro-Wilkes test|The p-value tests if the residuals are normally distributed.||||19.20|0.01|0.500
71836082|NCT04549168|143177710|SUPERIORITY||LSM difference|0.34||||0.0312|TWO_SIDED|95.0|0.03|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of treatment period|||0.65|0.03|0.0312
71836083|NCT04549168|143177710|SUPERIORITY||LSM difference|0.32||||0.146|TWO_SIDED|95.0|-0.11|0.76||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of treatment period|||0.76|-0.11|0.1460
71836084|NCT04549168|143177710|SUPERIORITY||LSM difference|0.29||||0.1613|TWO_SIDED|95.0|-0.12|0.7||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||First 7 mornings of follow-up period|||0.70|-0.12|0.1613
71836085|NCT04549168|143177710|SUPERIORITY||LSM difference|0.23||||0.2852|TWO_SIDED|95.0|-0.19|0.65||Data was analyzed using MMRM, and the missing values were imputed using multiple imputation and assumed to be MNAR.|MMRM||Last 7 mornings of follow-up period|||0.65|-0.19|0.2852
71836086|NCT02662062|143177740|OTHER|This is a single arm study looking at a binary value with the hypothesis suggesting it falls within a certain range.||||||||||||||||The null hypothesis is that the addition of pembrolizumab to chemoradiation is not unsafe (percentage of the population experiencing unacceptable toxicity is not \>50%)|A Clopper-Pearson method was used to determine the unacceptable toxicity rate and a 95% confidence interval for this binary outcome measure.|||
71836087|NCT02662062|143177741|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
71891763|NCT01478958|143305094|SUPERIORITY_OR_OTHER||||||>|0.05||||||Effect of n-6 PUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.||||||>0.05
71836088|NCT02662062|143177742|OTHER|Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||||||||||||||||Single arm study with no comparator arm and assessment of a binary variable. Clopper-Pearson method used to calculate the 95% confidence interval relating to this proportion.|||
71836089|NCT02662062|143177743|OTHER|Non comparative trial with a single arm|Kaplan Meier Estimate|39.0|||||TWO_SIDED|95.0|17.0||missing upper limit of 95% confidence interval on the survival estimate from Kaplan-Meier estimator due to small number events||||||||17|
71669087|NCT00683657|142854839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.16||0.0001|TWO_SIDED|95.0|-25.1|-8.5||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pre treatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-8.5|-25.1|0.0001
71836090|NCT02662062|143177744|OTHER|Kaplan Meier Estimate performed for a 12 month timepoint in a single arm non comparative study|Kaplan Meier Estimate|92.0|||||TWO_SIDED|95.0|72.0|98.0||||||||98|72|
71836091|NCT02662062|143177745|OTHER|Kaplan Meier Estimate of single arm non comparative study|Kaplan Meier Estimate|85.0|||||TWO_SIDED|95.0|64.0|94.0||||||||94|64|
71836092|NCT02662062|143177746|OTHER|Kaplan Meier estimate at a 12 month timepoint for a single arm non comparative study|Kaplan Meier Estimate|88.0|||||TWO_SIDED|95.0|68.0|98.0||||||||98|68|
71836093|NCT03988634|143177750|SUPERIORITY||Geometric Mean Ratio|0.8546||||0.0492|TWO_SIDED|95.0|0.7307|0.9994|||ANCOVA||Geometric Mean Ratio: sac/val vs valsartan|||0.9994|0.7307|0.0492
71836094|NCT03988634|143177751|SUPERIORITY||Win Ratio|1.193||||0.1578|TWO_SIDED|95.0|0.934|1.524|||unmatched pairwise win-ratio||A win ratio greater than 1 was in favor of sacubitril/valsartan arm|||1.524|0.934|0.1578
71836095|NCT03988634|143177752|SUPERIORITY||rate ratio|0.8346||||0.3563|TWO_SIDED|95.0|0.5684|1.2255|||LWYY model||A rate ratio \< 1 indicates an effect in favor of LCZ696|||1.2255|0.5684|0.3563
71836096|NCT03988634|143177753|SUPERIORITY||Rate ratio|0.6249||||0.3155|TWO_SIDED|95.0|0.2496|1.5649|||negative binomial regression model|||||1.5649|0.2496|0.3155
71677101|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0||||0.0001|TWO_SIDED|95.0|-17.91|-6.09||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-6.09|-17.91|0.0001
71836097|NCT03988634|143177754|SUPERIORITY||ratio of the change|0.9316||||0.4766|TWO_SIDED|95.0|0.7661|1.1329|||ANCOVA|||||1.1329|0.7661|0.4766
71836098|NCT03988634|143177755|SUPERIORITY||ratio of the change|0.8268|||<|0.0001|TWO_SIDED|95.0|0.76|0.91|||ANCOVA|||Week 4||0.91|0.76|<.0001
71836099|NCT03988634|143177755|SUPERIORITY||ratio of the change|0.8103|||<|0.0001|TWO_SIDED|95.0|0.74|0.89|||ANCOVA|||Week 8||0.89|0.74|<.0001
71836100|NCT04725240|143177758|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
71836101|NCT04725240|143177759|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
71836102|NCT04725240|143177760|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
71836103|NCT04725240|143177761|OTHER||||||<|0.0001||||||Threshold for significance at 0.001 level.|One-sided exact binomial test|||||||<0.0001
71836104|NCT00676715|143177776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
71836105|NCT00676715|143177776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||<0.0001
71836106|NCT00676715|143177776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7496|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).||||0.7496
71836107|NCT00676715|143177777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0019
71836108|NCT00676715|143177777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0136|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.0136
71836109|NCT00676715|143177777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1814|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.||||0.1814
71836110|NCT00676715|143177778|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.6||||0.1978|TWO_SIDED|95.0|0.27|1.34|||Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.||||1.34|0.27|0.1978
71836111|NCT00676715|143177778|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.53||||0.131|TWO_SIDED|95.0|0.23|1.22|||CMH chi-square test|CMH chi-square test stratified by geographical region only.||||1.22|0.23|0.1310
71836112|NCT00676715|143177778|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (RR)|0.92||||0.8206|TWO_SIDED|95.0|0.46|1.84|||CMH chi-square tes|CMH chi-square test stratified by geographical region only.||||1.84|0.46|0.8206
71836113|NCT00676715|143177779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1391
71836114|NCT00676715|143177779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1596|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.1596
71836115|NCT00676715|143177779|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4740
71836116|NCT00676715|143177780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
71836117|NCT00676715|143177780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
71836118|NCT00676715|143177780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4985|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.4985
71891764|NCT01499290|143305102|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-3.5|||||TWO_SIDED|95.0|-8.64|1.58||||||The primary objective of this study (FDA agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the mMITT in adult subjects with cIAI.||1.58|-8.64|
71891765|NCT01499290|143305103|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-6.9|2.1||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the MITT in adult subjects with cIAI.||2.10|-6.90|
71891766|NCT01499290|143305104|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.61|2.89||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the CE in adult subjects with cIAI.||2.89|-4.61|
71891767|NCT00655928|143305166|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71891768|NCT00215150|143305213|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Wilcoxon Signed Rank Test|||Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.||||< 0.001
71891769|NCT00215150|143305213|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.||||> .05
71752251|NCT04913610|143007891|OTHER||||||=|0.786||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.786
71752252|NCT04913610|143007891|OTHER||||||=|0.423||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.423
71752253|NCT04913610|143007891|OTHER||||||=|0.92||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.920
71783817|NCT02795832|143066651|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_DEVIATION|1.22||0.5233|TWO_SIDED|90.0|-2.02|2.16|||Shapiro-Wilkes test|||||2.16|-2.02|0.5233
71891770|NCT02091440|143305235|OTHER|Single group|Proportion|100.0|||||TWO_SIDED|95.0||||||||||||
71891771|NCT02091440|143305236|OTHER|Single group|Kaplan-Meier Survival|100.0|||||TWO_SIDED|||||||||||||
71783818|NCT02795832|143066652|SUPERIORITY||Odds Ratio (OR)|2.43||||0.2455|TWO_SIDED|95.0|0.45|13.26|||t-test, 1 sided|||||13.26|0.45|0.2455
71783819|NCT02795832|143066653|SUPERIORITY||Mean Difference (Net)|-2.66|STANDARD_ERROR_OF_MEAN|4.521||0.2812|TWO_SIDED|90.0|-10.4|5.09||The 1-sided p-value tests if the ZPL-5212372 LS mean is \< placebo LS mean.|Shapiro-Wilkes test|||||5.09|-10.40|0.2812
71783820|NCT04523220|143066657|OTHER||Cox Proportional Hazard|0.59|||=|0.222|TWO_SIDED|90.0|0.28|1.21||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.21|0.28|= 0.222
71783821|NCT04523220|143066657|OTHER||Cox Proportional Hazard|0.72|||=|0.427|TWO_SIDED|90.0|0.36|1.42||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.42|0.36|= 0.427
71783822|NCT04523220|143066658|OTHER||Cox Proportional Hazard|1.27|||=|0.128|TWO_SIDED|90.0|0.98|1.64||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.64|0.98|= 0.128
71783823|NCT04523220|143066658|OTHER||Cox Proportional Hazard|1.24|||=|0.166|TWO_SIDED|90.0|0.96|1.61||Due to the explorative nature of these analyses, no multiplicity adjustment was done.|Log Rank|||Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.||1.61|0.96|= 0.166
71891772|NCT02091440|143305237|OTHER|Single group|Incidence|1.24|||||TWO_SIDED|||||||||||||
71891773|NCT02091440|143305238|OTHER|Single group|Incidence|1.66|||||TWO_SIDED|||||||||||||
71891774|NCT02091440|143305239|OTHER|Single group|Change from baseline|19.4|STANDARD_DEVIATION|11.39|||TWO_SIDED|95.0|7.5|31.4|||||Confidence interval based on t-distribution.|||31.4|7.5|
71891775|NCT02091440|143305240|OTHER|Single group|Percentage change|-83.33|||||TWO_SIDED||||||||Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%|||||
71891776|NCT02091440|143305241|OTHER|Single group|Change from baseline|130.0|STANDARD_DEVIATION|275.32|||TWO_SIDED|95.0|-158.9|418.9|||||Confidence interval based on t-distribution.|||418.9|-158.9|
71891777|NCT03576144|143305243|OTHER||Slope|1.0474|STANDARD_ERROR_OF_MEAN|0.0283|||TWO_SIDED|90.0|0.9997|1.0951|||ANCOVA||Standard Error of the mean is actually standard error of slope.Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUC0-12 of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0951|0.9997|
71896220|NCT01709799|143314378|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,93.167)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.313
71669088|NCT00683657|142854840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-44.4|-16.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-16.1|-44.4|<0.0001
71752254|NCT04913610|143007892|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
71752255|NCT04913610|143007892|OTHER||||||=|0.981||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.981
71752256|NCT04913610|143007892|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
71752257|NCT04913610|143007892|OTHER||||||=|0.96||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.960
71752258|NCT04913610|143007893|OTHER||||||=|0.157||||||The p-value is for the pairwise comparison of Arm A to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.157
71836119|NCT00676715|143177781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.0004
71752259|NCT04913610|143007893|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm B to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
71752260|NCT04913610|143007893|OTHER||||||=|0.15||||||The p-value is for the pairwise comparison of Arm C to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.150
71752261|NCT04913610|143007893|OTHER||||||=|0.173||||||The p-value is for the pairwise comparison of Arm D to Arm E using the using the Chi-square test for the binary response per participant.|Chi-square test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.173
71752262|NCT04913610|143007894|OTHER||||||=|0.619||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.619
71752263|NCT04913610|143007894|OTHER||||||=|0.194||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.194
71752264|NCT04913610|143007894|OTHER||||||=|0.518||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.518
71752265|NCT04913610|143007894|OTHER||||||=|0.652||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.652
71677102|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.64|-6.32||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.|||-6.32|-15.64|<0.0001
71752266|NCT04913610|143007895|OTHER||||||=|0.386||||||The p-value is for the pairwise comparison of Arm A to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 pbo for 7 days (Arm A) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.386
71836120|NCT00676715|143177781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||<0.0001
71836121|NCT00676715|143177781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2725|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.||||||0.2725
71669089|NCT00683657|142854841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.4|STANDARD_ERROR_OF_MEAN|10.41||0.001|TWO_SIDED|95.0|-56.2|-14.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-14.7|-56.2|0.0010
71783824|NCT02010775|143066662|OTHER||Least Squares Mean (LS) Mean Difference|-3.88|||<|0.001|TWO_SIDED|95.0|-5.58|-2.19|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-2.19|-5.58|< 0.001
71783825|NCT02010775|143066662|OTHER||LS Mean Difference|-6.32|||<|0.001|TWO_SIDED|95.0|-8.02|-4.62|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-4.62|-8.02|<0.001
71783826|NCT02010775|143066662|OTHER||LS Mean Difference|-6.89|||<|0.001|TWO_SIDED|95.0|-8.56|-5.22|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-5.22|-8.56|<0.001
71669090|NCT00683657|142854842|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.7|STANDARD_ERROR_OF_MEAN|4.22|<|0.0001|TWO_SIDED|95.0|-27.1|-10.3||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-10.3|-27.1|<0.0001
71783827|NCT02010775|143066662|OTHER||LS Mean Difference|-7.68|||<|0.001|TWO_SIDED|95.0|-9.35|-6.0|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.||||-6.00|-9.35|<0.001
71783828|NCT02010775|143066663|OTHER||Percentage Difference|31.5||||0.008|TWO_SIDED|95.0|9.8|53.3|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using Cochran-Mantel-Haenszel (CMH) tests stratified by baseline MMPS.||||53.3|9.8|0.008
71783829|NCT02010775|143066663|OTHER||Percentage Difference|48.2|||<|0.001|TWO_SIDED|95.0|28.6|67.8|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||67.8|28.6|< 0.001
71783830|NCT02010775|143066663|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|< 0.001
71783831|NCT02010775|143066663|OTHER||Percentage Difference|54.3|||<|0.001|TWO_SIDED|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.||||72.6|36.1|<0.001
71783832|NCT00256750|143066664|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.7|||||TWO_SIDED|97.3|-1.1|9.0||||||||9.0|-1.1|
71783833|NCT00256750|143066664|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|2.7|||||TWO_SIDED|97.3|-2.5|8.1|||||If the lower bound of the CI (belatacept-CsA) was \> -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.|||8.1|-2.5|
71783834|NCT00256750|143066665|SUPERIORITY_OR_OTHER||Difference in Percent|-23.7|||<|0.0001|TWO_SIDED|97.3|-33.3|-13.7|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-13.7|-33.3|<.0001
71783835|NCT00256750|143066665|SUPERIORITY_OR_OTHER||Difference in Percent|-22.9|||<|0.0001|TWO_SIDED|97.3|-32.6|-12.9|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||||-12.9|-32.6|<.0001
71783836|NCT00256750|143066666|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|10.0|||||TWO_SIDED|97.3|3.3|17.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||17.1|3.3|
71783837|NCT00256750|143066666|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.5|22.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||22.2|7.5|
71783838|NCT00256750|143066667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|||<|0.0001|TWO_SIDED|97.3|7.3|18.7||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||18.7|7.3|<0.0001
71669091|NCT00683657|142854843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.0||0.0002|TWO_SIDED|95.0|-23.3|-7.4||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.||-7.4|-23.3|0.0002
71669092|NCT02586155|142854873|SUPERIORITY||Cox Proportional Hazard|0.823||||0.107|TWO_SIDED|95.0|0.649|1.044|||Stratified long-rank|||||1.044|0.649|0.1070
71669093|NCT02586155|142854874|SUPERIORITY||Cox Proportional Hazard|0.849||||0.1495|TWO_SIDED|95.0|0.679|1.061|||Stratified long-rank|||||1.061|0.679|0.1495
71669094|NCT02586155|142854875|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.03|TWO_SIDED|95.0|0.38|0.94|||Stratified long-rank|||||0.94|0.38|0.03
71752267|NCT04913610|143007895|OTHER||||||=|0.279||||||The p-value is for the pairwise comparison of Arm B to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole pbo for 7 days, then ABBV-4083 400 mg for 7 days (Arm B) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.279
71752268|NCT04913610|143007895|OTHER||||||=|0.385||||||The p-value is for the pairwise comparison of Arm C to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083 400 mg + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm C) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.385
71752269|NCT04913610|143007895|OTHER||||||=|0.755||||||The p-value is for the pairwise comparison of Arm D to Arm E using the Mann-Whitney U test for the change from baseline in skin microfilarial density per participant.|Mann-Whitney U test|||Part 1: ABBV-4083/albendazole 400 mg 3 d; ABBV-4083 400 mg/albendazole pbo 4 d; ABBV-4083 pbo 7 d (Arm D) versus Part 1: ABBV-4083 pbo + albendazole 400 mg for 7 days, then ABBV-4083 pbo for 7 days (Arm E)||||=0.755
71752270|NCT01210716|143007897|NON_INFERIORITY_OR_EQUIVALENCE|If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value \<=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%.|Mean Difference (Final Values)|6.69|STANDARD_DEVIATION|6.97|<|0.001|ONE_SIDED|95.0|4.0||||paired t-test|||A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.|||4.0|<0.001
71752271|NCT02913482|143007920|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71752272|NCT02913482|143007921|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71752273|NCT02913482|143007922|SUPERIORITY|Result compared to a performance criterion of 17% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71752274|NCT02913482|143007928|SUPERIORITY|Result compared to a performance criterion of 12% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71783839|NCT00256750|143066667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|||<|0.0001|TWO_SIDED|97.3|8.9|20.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12||20.4|8.9|<0.0001
71669095|NCT02586155|142854876|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.44|TWO_SIDED|95.0|0.62|1.24|||Stratified long-rank|||||1.24|0.62|0.44
71669096|NCT02586155|142854887|SUPERIORITY||Cox Proportional Hazard|0.78||||0.03|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.03
71669097|NCT04779879|142854893|OTHER||Ratio of geometric least squares mean|1.04|||||TWO_SIDED|90.0|0.98|1.09|||||Analysis was performed using an Analysis of covariance (ANCOVA) model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.09|0.98|
71669098|NCT04779879|142854894|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment, and Baseline logarithm (base10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.11|0.94|
71752275|NCT02913482|143007930|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71752276|NCT02913482|143007931|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.|||||<|0.0001|||||||One-sided Exact Binomial Test|||||||<0.0001
71752277|NCT02913482|143007932|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
71752278|NCT02913482|143007933|SUPERIORITY|Result compared to a performance criterion of 5% derived from natural history data.||||||1|||||||One-sided Exact Binomial Test|||||||1.0000
71752279|NCT02913482|143007937|SUPERIORITY|Result compared to a performance criterion of 42% derived from natural history data. Statistical analysis was only performed for Month 12 data.|||||<|0.0001|||||||One-sided Z-test|||||||<0.0001
71752280|NCT02913482|143007938|SUPERIORITY|Result compared to a performance criterion of 60% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.0005|||||||One-sided Z-test|||||||0.0005
71783840|NCT00256750|143066667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4|||<|0.0001|TWO_SIDED|97.3|11.5|23.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||23.4|11.5|<0.0001
71669099|NCT04779879|142854923|OTHER||Ratio of geometric least squares mean|1.05|||||TWO_SIDED|90.0|1.0|1.11|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.11|1.00|
71669100|NCT04779879|142854924|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Analysis was performed using an ANCOVA model with covariates of treatment and Baseline logarithm (base 10) viral load.|||1.07|0.97|
71669101|NCT04779879|142854925|OTHER||Ratio of geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.93|1.09|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.09|0.93|
71783841|NCT00256750|143066667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.5|||<|0.0001|TWO_SIDED|97.3|8.5|20.5||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24||20.5|8.5|<0.0001
71783842|NCT00256750|143066668|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-8.5||||0.0581|TWO_SIDED|97.3|-17.9|0.9|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||0.9|-17.9|0.0581
71783843|NCT00256750|143066668|NON_INFERIORITY_OR_EQUIVALENCE|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-14.2||||0.001|TWO_SIDED|97.3|-23.2|-5.0|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.||||-5.0|-23.2|0.0010
71783844|NCT00256750|143066673|SUPERIORITY_OR_OTHER||Difference in Percent|-8.5|||||TWO_SIDED|97.3|-14.6|-3.3|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-3.3|-14.6|
71783845|NCT00256750|143066673|SUPERIORITY_OR_OTHER||Difference in Percent|-10.3|||||TWO_SIDED|97.3|-16.1|-5.1|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine||-5.1|-16.1|
71783846|NCT00256750|143066677|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.3|||||TWO_SIDED|97.3|10.3|20.3|||||ANOVA model: GFR = treatment|Month 12||20.3|10.3|
71783847|NCT00256750|143066677|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|15.1|||||TWO_SIDED|97.3|10.1|20.1|||||ANOVA model: GFR = treatment|Month 12||20.1|10.1|
71783848|NCT00256750|143066677|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.5|||||TWO_SIDED|97.3|12.0|23.1|||||ANOVA model: GFR = treatment|Month 24||23.1|12.0|
71836122|NCT01820260|143177783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED|||||To account for multiple testing, the 4 pairwise tests with corresponding vehicle group were performed using Bonferroni method testing at a 1.25% significance level, securing that the overall significance level did not exceed 5%|Fisher Exact|||Complete clearance of AKs at Week 8 was to be analysed by log binomial regression with factors treatment group, anatomical location (face/chest or scalp) and analysis site. Due to the low numbers of subjects obtaining complete clearance in the vehicle groups,the proposed model did not converge and Fisher's exact test was used instead to compare active treatments with the respective vehicle arm.||||0.0002
71836123|NCT01820260|143177783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|TWO_SIDED|||||see comments in analysis 1|Fisher Exact|||See comment in analysis 1||||0.0037
71669102|NCT04779879|142854926|OTHER||Ratio of geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.94|1.1|||||Analysis was performed using an ANCOVA model with covariates of treatment, Baseline logarithm (base 10) viral load and randomization stratification factor (prior exposure to an authorized or approved SARS-CoV-2 vaccine).|||1.10|0.94|
71669103|NCT04779879|142854987|OTHER||Ratio of geometric least squares mean|0.66|||||TWO_SIDED|90.0|0.48|0.89|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.89|0.48|
71783849|NCT00256750|143066677|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|17.6|||||TWO_SIDED|97.3|12.0|23.3|||||ANOVA model: GFR = treatment|Month 24||23.3|12.0|
71783850|NCT00256750|143066677|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|21.4|||||TWO_SIDED|97.3|15.4|27.4|||||ANOVA model: GFR = treatment|Month 36||27.4|15.4|
71783851|NCT00256750|143066677|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|20.8|||||TWO_SIDED|97.3|14.8|26.9|||||ANOVA model: GFR = treatment|Month 36||26.9|14.8|
71783852|NCT00256750|143066679|SUPERIORITY_OR_OTHER||Difference in Percent|-5.7||||0.0687|TWO_SIDED|97.3|-12.6|0.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||0.5|-12.6|0.0687
71783853|NCT00256750|143066679|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8||||0.4825|TWO_SIDED|97.3|-10.2|4.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12||4.4|-10.2|0.4825
71783854|NCT00256750|143066679|SUPERIORITY_OR_OTHER||Difference in Percent|-5.1||||0.1267|TWO_SIDED|97.3|-12.3|1.5||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||1.5|-12.3|0.1267
71783855|NCT00256750|143066679|SUPERIORITY_OR_OTHER||Difference in Percent|-2.2||||0.6405|TWO_SIDED|97.3|-9.8|5.4||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24||5.4|-9.8|0.6405
71836124|NCT01820260|143177783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0171|TWO_SIDED|||||See comments in analysis 1|Fisher Exact|||See comments in analysis 1||||0.0171
71836125|NCT01820260|143177783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||||||0.0001
71783856|NCT00256750|143066679|SUPERIORITY_OR_OTHER||Difference in Percent|-4.6||||0.2043|TWO_SIDED|97.3|-12.0|2.5|||Chi-squared|Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.||Month 36||2.5|-12.0|0.2043
71783857|NCT00256750|143066679|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9||||0.9481|TWO_SIDED|97.3|-8.8|7.1||Normal approximation is used if N\>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 36||7.1|-8.8|0.9481
71783858|NCT00256750|143066680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.0002|TWO_SIDED|97.3|0.31|0.74|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.74|0.31|0.0002
71783859|NCT00256750|143066680|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.6||||0.0092|TWO_SIDED|97.3|0.38|0.92|||Chi-squared||Odds ratio is estimated by a cumulative logit model.|||0.92|0.38|0.0092
71783860|NCT00256750|143066681|SUPERIORITY_OR_OTHER||Difference in Percent|-21.2|||||TWO_SIDED|97.3|-67.6|43.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||43.2|-67.6|
71783861|NCT00256750|143066681|SUPERIORITY_OR_OTHER||Difference in Percent|-17.9|||||TWO_SIDED|97.3|-72.3|52.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||52.2|-72.3|
71783862|NCT00256750|143066682|SUPERIORITY_OR_OTHER||Difference in Percent|-1.13|||||TWO_SIDED|97.3|-7.51|5.23|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||5.23|-7.51|
71783863|NCT00256750|143066682|SUPERIORITY_OR_OTHER||Difference in Percent|-2.37|||||TWO_SIDED|97.3|-9.01|4.15|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 12||4.15|-9.01|
71783864|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.3|||||TWO_SIDED|97.3|-11.4|-3.3||||||Systolic, Month 12||-3.3|-11.4|
71783865|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-6.0|||||TWO_SIDED|97.3|-10.1|-2.0||||||Systolic, Month 12||-2.0|-10.1|
71783866|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.2|||||TWO_SIDED|97.3|-5.8|-0.7||||||Diastolic, Month 12||-0.7|-5.8|
71783867|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.6|||||TWO_SIDED|97.3|-5.1|0.0||||||Diastolic, Month 12||0.0|-5.1|
71836126|NCT01820260|143177784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||To account for multiple testing among the secondary endpoints, a hierarchical order of testing was determined, where the following evaluation was done separately for each of the four active groups: Provided the primary endpoint was significant at a 1.25% level, the comparison to vehicle in terms of reduction in AK count from baseline to week 8 was tested at a 1.25% level. Provided this test was significant, the second secondary endpoint,partial clearance, was tested(vs. vehicle) at a 1.25% level||||< 0.001
71836127|NCT01820260|143177784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment in analysis 1||||< 0.001
71836128|NCT01820260|143177784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||z-test|||See comment analysis 1||||< 0.001
71783868|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-4.9|||||TWO_SIDED|97.3|-9.2|-0.6||||||Systolic, Month 24||-0.6|-9.2|
71783869|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.5|||||TWO_SIDED|97.3|-9.9|-1.1||||||Systolic, Month 24||-1.1|-9.9|
71783870|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-1.9|||||TWO_SIDED|97.3|-4.4|0.5||||||Diastolic, Month 24||0.5|-4.4|
71783871|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.4|||||TWO_SIDED|97.3|-5.0|0.1||||||Diastolic, Month 24||0.1|-5.0|
71836129|NCT01820260|143177784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||z-test|||See comment in analysis 1||||< 0.001
71836130|NCT01820260|143177785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||Analysis of partial clearance of AK's at Week 8 was done in the same way as for the primary outcome (endpoint)||||<0.001
71836131|NCT01820260|143177785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71836132|NCT01820260|143177785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71669104|NCT04779879|142854987|OTHER||Ratio of geometric least squares mean|0.58|||||TWO_SIDED|90.0|0.43|0.79|||||Drug bioavailability was analyzed using an ANCOVA model with treatment and weight at Baseline as covariates.|||0.79|0.43|
71783872|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-5.8|||||TWO_SIDED|97.3|-10.0|-1.6||||||Systolic, Month 36||-1.6|-10.0|
71783873|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-7.5|||||TWO_SIDED|97.3|-11.7|-3.3||||||Systolic, Month 36||-3.3|-11.7|
71783874|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-2.9|||||TWO_SIDED|97.3|-5.4|-0.4||||||Diastolic, Month 36||-0.4|-5.4|
71783875|NCT00256750|143066683|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-3.4|||||TWO_SIDED|97.3|-6.0|-0.9||||||Diastolic, Month 36||-0.9|-6.0|
71783876|NCT00256750|143066684|SUPERIORITY_OR_OTHER||Difference in Percent|7.1|||||TWO_SIDED|97.3|-2.9|17.1|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||17.1|-2.9|
71783877|NCT00256750|143066684|SUPERIORITY_OR_OTHER||Difference in Percent|3.2|||||TWO_SIDED|97.3|-6.6|12.9|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12||12.9|-6.6|
71783878|NCT00256750|143066685|SUPERIORITY_OR_OTHER||Difference in Percent|7.01|||||TWO_SIDED|97.3|-2.79|16.71|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||16.71|-2.79|
71783879|NCT00256750|143066685|SUPERIORITY_OR_OTHER||Difference in Percent|3.77|||||TWO_SIDED|97.3|-5.86|13.35|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||13.35|-5.86|
71783880|NCT00256750|143066690|SUPERIORITY_OR_OTHER||Difference in Percent|-10.4|||||TWO_SIDED|97.3|-21.4|1.0||||||||1.0|-21.4|
71836133|NCT01820260|143177785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71836134|NCT02867384|143177805|SUPERIORITY|||||||0.0008|||||||Fisher Exact|||||||0.0008
71845402|NCT01478594|143205112|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.755|||||TWO_SIDED|95.0|0.375|1.521|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.521|0.375|
71783881|NCT00256750|143066690|SUPERIORITY_OR_OTHER||Difference in Percent|-8.7|||||TWO_SIDED|97.3|-19.9|2.7||||||||2.7|-19.9|
71783882|NCT00256750|143066692|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|11.4|||||TWO_SIDED|97.3|5.0|18.2|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||18.2|5.0|
71783883|NCT00256750|143066692|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|16.5|||||TWO_SIDED|97.3|9.6|23.8|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 6||23.8|9.6|
71783884|NCT00256750|143066692|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|8.2|||||TWO_SIDED|97.3|1.2|15.4|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used|Month 24||15.4|1.2|
71783885|NCT00256750|143066692|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|15.2|||||TWO_SIDED|97.3|7.5|23.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 24||23.0|7.5|
71783886|NCT00256750|143066692|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|7.8|||||TWO_SIDED|97.3|0.6|15.0|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||15.0|0.6|
71783887|NCT00256750|143066692|NON_INFERIORITY_OR_EQUIVALENCE|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|14.7|||||TWO_SIDED|97.3|7.0|22.6|||||For 97.3% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|Month 36||22.6|7.0|
71783888|NCT00256750|143066694|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
71783889|NCT00256750|143066694|SUPERIORITY_OR_OTHER||Difference in Percent|-3.2|||||TWO_SIDED|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N\>=5 in both arms. Otherwise exact method is used.|||-0.6|-6.6|
71783890|NCT00256750|143066698|SUPERIORITY_OR_OTHER||Difference in Percent|-0.5|||||TWO_SIDED|97.3|-6.5|5.3||||||Month 12||5.3|-6.5|
71836135|NCT04936035|143177861|SUPERIORITY||Difference in LS Mean|-16.7|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.2|-12.3||MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 300 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-12.3|-21.2|<0.0001
71836136|NCT04936035|143177861|SUPERIORITY||Difference in LS Mean|-15.7|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-20.8|-10.6||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|The adjusted 95% CI and p-value are based on Dunnett's test.|LS Mean Difference between zilebesiran 600 mg Q6M and placebo, 95% CI was calculated using Dunnett's procedure.|||-10.6|-20.8|<0.0001
71836137|NCT04936035|143177862|SUPERIORITY||Difference in LS Mean|-12.0|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-15.7|-8.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-8.3|-15.7|<0.0001
71669105|NCT04779879|142854988|OTHER||Ratio of geometric least squares mean|1.14|||||TWO_SIDED|90.0|0.67|1.95|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.95|0.67|
71783891|NCT00256750|143066698|SUPERIORITY_OR_OTHER||Difference in Percent|-0.9|||||TWO_SIDED|97.3|-6.9|4.8||||||||4.8|-6.9|
71783892|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6573|TWO_SIDED|95.0|-1.6|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.6|-1.6|0.6573
71783893|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1198|TWO_SIDED|95.0|-0.4|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.4|0.1198
71836138|NCT04936035|143177862|SUPERIORITY||Difference in LS Mean|-9.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.0001|TWO_SIDED|95.0|-13.4|-4.8||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-4.8|-13.4|<0.0001
71783894|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.0672|TWO_SIDED|95.0|-0.1|3.2||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.2|-0.1|0.0672
71783895|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0257|TWO_SIDED|95.0|0.2|3.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.6|0.2|0.0257
71783896|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4146|TWO_SIDED|95.0|-1.2|2.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.9|-1.2|0.4146
71783897|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7327|TWO_SIDED|95.0|-1.7|2.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.4|-1.7|0.7327
71783898|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0144|TWO_SIDED|95.0|0.4|3.8||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.8|0.4|0.0144
71783899|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||4.5|1.1|0.0015
71783900|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.234|TWO_SIDED|95.0|-0.8|3.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.8|0.2340
71783901|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6635|TWO_SIDED|95.0|-1.7|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.6|-1.7|0.6635
71783902|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0417|TWO_SIDED|95.0|0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.5|0.1|0.0417
71783903|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0026|TWO_SIDED|95.0|0.9|4.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||4.4|0.9|0.0026
71783904|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0953|TWO_SIDED|95.0|-0.3|4.1||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.1|-0.3|0.0953
71813107|NCT03720938|143128560|SUPERIORITY|||||||0.250006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.||||0.250006
71813108|NCT03720938|143128561|SUPERIORITY|||||||0||||||The outcome of visual reaction time was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the weight at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.000
71813109|NCT03720938|143128561|SUPERIORITY|Adjusted for the weight at baseline and confounding variable age.||||||1.196e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of visual reaction time was tested for any difference between groups by linear mixed-effects model analysis.||||0.00001196
71669106|NCT04779879|142854989|OTHER||Ratio of geometric least squares mean|1.06|||||TWO_SIDED|90.0|0.69|1.62|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.62|0.69|
71836139|NCT04936035|143177863|SUPERIORITY||Difference in LS Mean|-14.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|-18.9|-9.4||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.4|-18.9|<0.0001
71669107|NCT04779879|142854990|OTHER||Ratio of geometric least squares mean|1.11|||||TWO_SIDED|90.0|0.68|1.82|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||1.82|0.68|
71669108|NCT04779879|142854991|OTHER||Ratio of geometric least squares mean|1.28|||||TWO_SIDED|90.0|0.77|2.12|||||Dose proportionality was analyzed using an ANOVA model with treatment (250mg, 500mg) as a covariate, for each parameter of interest.|||2.12|0.77|
71669109|NCT01168427|142855033|OTHER|There was no formal statistical hypothesis tested. The goal was to estimate the procedure-related complications 90 days post implant using the Kaplan-Meier method.|Rate|0.034|||||ONE_SIDED|95.0||0.1292||||||||0.1292||
71752281|NCT02913482|143007939|SUPERIORITY|Result compared to a performance criterion of 89% derived from natural history data. Statistical analysis was only performed for Month 12 data.||||||0.2595|||||||One-sided Z-test|||||||0.2595
71752282|NCT01983228|143007952|SUPERIORITY||Odds Ratio (OR)|1.61||||0.09|TWO_SIDED|95.0|0.94|2.77||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.77|0.94|0.09
71752283|NCT01983228|143007953|SUPERIORITY||Median Difference (Final Values)|-0.2||||0.34|TWO_SIDED|95.0|-0.62|0.21||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.21|-0.62|0.34
71752284|NCT01983228|143007954|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.38|TWO_SIDED|95.0|-1.69|0.65||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.65|-1.69|0.38
71752285|NCT01983228|143007955|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.28|TWO_SIDED|95.0|-1.68|0.49||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.49|-1.68|0.28
71752286|NCT01983228|143007956|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED|95.0|0.0|0.77||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.77|-0.00|0.05
71752287|NCT01983228|143007957|SUPERIORITY|Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Mean Difference (Final Values)|193.9||||0.56|TWO_SIDED|95.0|-454.93|842.73||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||842.73|-454.93|0.56
71752288|NCT01983228|143007958|SUPERIORITY||Odds Ratio (OR)|1.49||||0.16|TWO_SIDED|95.0|0.85|2.62||Multiple logistic regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||measured change as a responder yes/no (30% or greater improvement from baseline).||2.62|0.85|0.16
71752289|NCT01983228|143007959|SUPERIORITY||Mean Difference (Final Values)|-0.61||||0.002|TWO_SIDED|95.0|-0.99|-0.23||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.23|-0.99|0.002
71752290|NCT01983228|143007960|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.54|TWO_SIDED|95.0|-0.79|1.51||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.51|-0.79|0.54
71752291|NCT01983228|143007961|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|95.0|-0.66|1.62||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.62|-0.66|0.41
71752292|NCT01983228|143007962|SUPERIORITY||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.38||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||-0.38|-1.07|<0.0001
71752293|NCT01983228|143007963|SUPERIORITY||Mean Difference (Final Values)|540.78||||0.06|TWO_SIDED|95.0|-28.77|1110.33||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1110.33|-28.77|0.06
71752294|NCT01983228|143007964|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.05|TWO_SIDED|95.0|-0.01|5.86||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||5.86|-0.01|0.05
71752295|NCT01983228|143007965|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.01|TWO_SIDED|95.0|0.15|1.36||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.36|0.15|0.01
71752296|NCT01983228|143007966|SUPERIORITY||Mean Difference (Final Values)|-1.07||||0.15|TWO_SIDED|95.0|-2.53|0.39||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.39|-2.53|0.15
71752297|NCT01983228|143007967|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.56|TWO_SIDED|95.0|-0.8|1.47||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||1.47|-0.80|0.56
71752298|NCT01983228|143007968|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.38|TWO_SIDED|95.0|-0.17|0.46||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.46|-0.17|0.38
71752299|NCT01983228|143007969|SUPERIORITY||Odds Ratio (OR)|1.2||||0.56|TWO_SIDED|95.0|0.66|2.19||Logistic regression modeling the odds of yes to using opioids for pain treatment adjusting for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Logistic|||||2.19|0.66|0.56
71836140|NCT04936035|143177863|SUPERIORITY||Difference in LS Mean|-14.2|STANDARD_ERROR_OF_MEAN|2.38|<|0.0001|TWO_SIDED|95.0|-18.9|-9.5||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with baseline 24-hour mean SBP assessed by ABPM as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-9.5|-18.9|<0.0001
71836141|NCT04936035|143177864|SUPERIORITY||Difference in LS Mean|-12.1|STANDARD_ERROR_OF_MEAN|2.55|<|0.0001|TWO_SIDED|95.0|-17.2|-7.1||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-7.1|-17.2|<0.0001
71836142|NCT04936035|143177864|SUPERIORITY||Difference in LS Mean|-10.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-15.1|-5.3||The MMRM model included treatment, visit, treatment-by-visit interaction, and race (categorized as Black and all other races) as fixed factors, with office SBP as a covariate.|MMRM|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||-5.3|-15.1|<0.0001
71891778|NCT03576144|143305244|OTHER||Slope|1.0091|STANDARD_ERROR_OF_MEAN|0.038|||TWO_SIDED|90.0|0.9451|1.0732|||ANCOVA||Standard Error of the is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.0732|0.9451|
71752300|NCT01983228|143007970|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.18|0.84||Multiple linear regression adjusted for use of walking aids and opioids (both significantly difference between arms at baseline).|Regression, Linear|||||0.84|-0.18|0.21
71752301|NCT02005016|143007974|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).|||||<|0.005|||||||t-test, 1 sided|||||||<0.005
71752302|NCT02005016|143007975|OTHER|This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71752303|NCT01323582|143007992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|11.7||0.76|TWO_SIDED|95.0|-21.5|28.6|||t-test, 2 sided|Satterthwaite corrected t-test was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||28.6|-21.5|0.76
71752304|NCT01323582|143007993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65||95.0|-4.8|7.5|||t-test, 2 sided|Satterthwaite Correction used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.||7.5|-4.8|0.65
71752305|NCT01323582|143007994|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.3||0.88|TWO_SIDED|95.0|-4.58|5.19|||t-test, 2 sided|Satterthwaite correction for unequal standard deviations was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Half of the period 2 minus period 1 differences were used, since the difference between these two derived means is an unbiased estimate of the effect size.||5.19|-4.58|0.88
71752306|NCT01323582|143007995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|5.7||0.8|TWO_SIDED|95.0|-13.9|10.9|||t-test, 2 sided|Satterthwaite Corrected t-test|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|||10.9|-13.9|0.80
71752307|NCT01323582|143007996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.8|STANDARD_ERROR_OF_MEAN|9.1||0.21|TWO_SIDED|95.0|-30.9|7.3|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||7.3|-30.9|0.21
71752308|NCT01323582|143007997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|STANDARD_ERROR_OF_MEAN|6.61||0.034|TWO_SIDED|95.0|-28.7|-1.26|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.|||-1.26|-28.7|0.034
71752309|NCT01323582|143007998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.32|STANDARD_ERROR_OF_MEAN|1.98||0.015|TWO_SIDED|95.0|-9.48|-1.16|||t-test, 2 sided||Lower scores are favorable.|||-1.16|-9.48|0.015
71752310|NCT01323582|143007999|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.4|STANDARD_ERROR_OF_MEAN|2.2||0.0083|TWO_SIDED|95.0|-10.97|-1.83|||t-test, 2 sided||Lower scores are favorable.|||-1.83|-10.97|0.0083
71752311|NCT00083889|143008001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5268|||<|0.0001|TWO_SIDED|95.0|0.4316|0.643||p-value from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.||0.6430|0.4316|<0.0001
71752312|NCT00083889|143008001|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5136|||<|1e-05|TWO_SIDED|95.0|0.4196|0.6288||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-a).||0.6288|0.4196|<.00001
71752313|NCT00083889|143008002|SUPERIORITY_OR_OTHER||treatment difference|30.93|||<|0.001|TWO_SIDED|95.0|25.31|36.56|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||36.56|25.31|<0.001
71752314|NCT00083889|143008003|SUPERIORITY_OR_OTHER||treatment difference|33.66|||<|0.001|TWO_SIDED|95.0|27.62|39.69|||Chi-squared||95% confidence interval was calculated based on a normal distribution.|||39.69|27.62|<0.001
71752315|NCT00083889|143008004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.051|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0510
71752316|NCT00083889|143008004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8209||||0.0128|TWO_SIDED|95.0|0.673|1.0013||p-value is from 2-sided, unstratified tests.|Wilcoxon (Mann-Whitney)||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||1.0013|0.6730|0.0128
71752317|NCT00083889|143008004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8179||||0.049|TWO_SIDED|95.0|0.6692|0.9995||p-value is from 2-sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.9995|0.6692|0.0490
71752318|NCT00083889|143008005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5332|||<|0.0001|TWO_SIDED|95.0|0.4345|0.6544||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6544|0.4345|<0.0001
71752319|NCT00083889|143008005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516|||<|1e-05|TWO_SIDED|95.0|0.4191|0.6352||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-a)||0.6352|0.4191|<.00001
71752320|NCT00083889|143008006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5454|||<|0.0001|TWO_SIDED|95.0|0.4558|0.6526||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio \> 1 indicates a reduction in hazard rate in favor of IFN-a.|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6526|0.4558|<0.0001
71752321|NCT00083889|143008006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5417|||<|1e-05|TWO_SIDED|95.0|0.4519|0.6492||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN-a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN-α)||0.6492|0.4519|<.00001
71752322|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.913|||<|0.0001|TWO_SIDED|95.0|1.376|2.45|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) baseline score (intercept and time since randomization are included as random effects).||2.450|1.376|<.0001
71752323|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.935|||<|0.0001|TWO_SIDED|95.0|1.421|2.449|||Mixed Models Analysis|||Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.449|1.421|<.0001
71783905|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1961|TWO_SIDED|95.0|-0.8|3.7||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||3.7|-0.8|0.1961
71752324|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.948|||<|0.0001|TWO_SIDED|95.0|1.443|2.452|||Mixed Models Analysis|||Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.452|1.443|<.0001
71752325|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001|TWO_SIDED|95.0|1.476|2.464|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.464|1.476|<.0001
71752326|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.983|||<|0.0001|TWO_SIDED|95.0|1.491|2.475|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.475|1.491|<.0001
71752327|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.005|||<|0.0001|TWO_SIDED|95.0|1.51|2.501|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.501|1.510|<.0001
71783906|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0191|TWO_SIDED|95.0|0.3|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.9|0.3|0.0191
71836143|NCT04936035|143177865|SUPERIORITY||Odds Ratio (OR)|10.73|||<|0.0001|TWO_SIDED|95.0|3.76|30.64||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||30.64|3.76|<0.0001
71836144|NCT04936035|143177865|SUPERIORITY||Odds Ratio (OR)|17.93|||<|0.0001|TWO_SIDED|95.0|6.24|51.52||Logistic regression model included treatment and race (black; all other races) as factors and baseline 24-hour mean SBP as a covariate|Regression, Logistic|Tested in hierarchical order with success criterion of nominal p-value \<0.05.||||51.52|6.24|<0.0001
71836145|NCT05529966|143177915|OTHER|||||||0.45490734||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.45490734
71836146|NCT05529966|143177916|OTHER|||||||0.9237611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.92376110
71836147|NCT05529966|143177917|OTHER|||||||0.94342221||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.94342221
71836148|NCT05529966|143177918|OTHER|||||||0.38902793||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||||||0.38902793
71836149|NCT05529966|143177919|OTHER|||||||0.0042494||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of comfort score||||0.00424940
71669110|NCT02456740|142855050|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.88|-0.92|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.92|-1.88|< 0.001
71752328|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.018|||<|0.0001|TWO_SIDED|95.0|1.517|2.519|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.519|1.517|<.0001
71752329|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.0001|TWO_SIDED|95.0|1.522|2.559|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.559|1.522|<.0001
71752330|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.053|||<|0.0001|TWO_SIDED|95.0|1.522|2.584|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.584|1.522|<.0001
71752331|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.075|||<|0.0001|TWO_SIDED|95.0|1.515|2.635|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.635|1.515|<.0001
71836150|NCT05529966|143177919|OTHER|||||||0.00223547||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.00223547
71836151|NCT05529966|143177919|OTHER|||||||1.858e-05||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.00001858
71836152|NCT05529966|143177919|OTHER|||||||0.03003194||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.03003194
71836153|NCT05529966|143177919|OTHER|||||||2.8e-07||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.00000028
71836154|NCT05529966|143177919|OTHER|||||||0.00112148||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.00112148
71891779|NCT03576144|143305245|OTHER||Slope|1.052|STANDARD_ERROR_OF_MEAN|0.0325|||TWO_SIDED|90.0|0.9972|1.1069|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for AUCτ,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1069|0.9972|
71896221|NCT01709799|143314379|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,115.573)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value \> .05)||||0.630
71752332|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||<|0.0001|TWO_SIDED|95.0|1.509|2.667|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.667|1.509|<.0001
71752333|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|||<|0.0001|TWO_SIDED|95.0|1.494|2.727|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.727|1.494|<.0001
71669111|NCT02456740|142855050|SUPERIORITY|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.33|-1.37|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.37|-2.33|< 0.001
71752334|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.123|||<|0.0001|TWO_SIDED|95.0|1.483|2.763|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.763|1.483|<.0001
71752335|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001|TWO_SIDED|95.0|1.461|2.83|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.830|1.461|<.0001
71752336|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.158|||<|0.0001|TWO_SIDED|95.0|1.447|2.869|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.869|1.447|<.0001
71752337|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.181|||<|0.0001|TWO_SIDED|95.0|1.42|2.941|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.941|1.420|<.0001
71752338|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.193|||<|0.0001|TWO_SIDED|95.0|1.404|2.983|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||2.983|1.404|<.0001
71752339|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.216|||<|0.0001|TWO_SIDED|95.0|1.373|3.059|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.059|1.373|<.0001
71752340|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.228|||<|0.0001|TWO_SIDED|95.0|1.355|3.102|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.102|1.355|<.0001
71752341|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.251|||<|0.0001|TWO_SIDED|95.0|1.321|3.18|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.180|1.321|<.0001
71752342|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.263|||<|0.0001|TWO_SIDED|95.0|1.302|3.225|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.225|1.302|<.0001
71752343|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.286|||<|0.0001|TWO_SIDED|95.0|1.266|3.305|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.305|1.266|<.0001
71783907|NCT00256750|143066700|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0684|TWO_SIDED|95.0|-0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.5|-0.1|0.0684
71752344|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001|TWO_SIDED|95.0|1.246|3.351|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.351|1.246|<.0001
71752345|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.321|||<|0.0001|TWO_SIDED|95.0|1.209|3.433|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.433|1.209|<.0001
71783908|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0714|TWO_SIDED|95.0|-0.2|3.9|||ANOVA|Domain Score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||3.9|-0.2|0.0714
71783909|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0536|TWO_SIDED|95.0|0.0|4.1|||ANOVA|Domain score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6||4.1|-0.0|0.0536
71669112|NCT02456740|142855051|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.52|2.98|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.98|1.52|< 0.001
71752346|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.333|||<|0.0001|TWO_SIDED|95.0|1.188|3.479|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.479|1.188|<.0001
71752347|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.356||||0.0001|TWO_SIDED|95.0|1.15|3.562|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.562|1.150|0.0001
71752348|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.369||||0.0002|TWO_SIDED|95.0|1.128|3.609|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.609|1.128|0.0002
71752349|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.391||||0.0003|TWO_SIDED|95.0|1.089|3.693|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.693|1.089|0.0003
71752350|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.404||||0.0004|TWO_SIDED|95.0|1.067|3.74|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.740|1.067|0.0004
71783910|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7543|TWO_SIDED|95.0|-1.6|2.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||2.2|-1.6|0.7543
71783911|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.2499|TWO_SIDED|95.0|-0.8|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6||3.0|-0.8|0.2499
71783912|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.2||||0.8332|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||2.3|-1.9|0.8332
71783913|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2523|TWO_SIDED|95.0|-0.9|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6||3.4|-0.9|0.2523
71783914|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3018|TWO_SIDED|95.0|-0.8|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.7|-0.8|0.3018
71783915|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.6||||0.5437|TWO_SIDED|95.0|-1.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6||2.3|-1.2|0.5437
71783916|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.237|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||3.6|-0.9|0.2370
71783917|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0588|TWO_SIDED|95.0|-0.1|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6||4.5|-0.1|0.0588
71783918|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0502|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Physical, Month 6||4.0|-0.0|0.0502
71783919|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.6||||0.0007|TWO_SIDED|95.0|1.5|5.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 6||5.6|1.5|0.0007
71783920|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.3||||0.7637|TWO_SIDED|95.0|-1.8|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.4|-1.8|0.7637
71836155|NCT05529966|143177919|OTHER|||||||951||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||00000951
71836156|NCT05529966|143177919|OTHER|||||||0.03493564||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.03493564
71836157|NCT05529966|143177919|OTHER|||||||0.12895248||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.12895248
71836158|NCT05529966|143177919|OTHER|||||||0.00279611||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.00279611
71836159|NCT05529966|143177920|OTHER|||||||0.959638658||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Comfort score||||.959638658
71783921|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.7006|TWO_SIDED|95.0|-1.7|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6||2.5|-1.7|0.7006
71752351|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.426||||0.0007|TWO_SIDED|95.0|1.027|3.825|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.825|1.027|0.0007
71752352|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.439||||0.0009||95.0|1.005|3.872|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.872|1.005|0.0009
71752353|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.461||||0.0013|TWO_SIDED|95.0|0.964|3.958|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||3.958|0.964|0.0013
71752354|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.474||||0.0016|TWO_SIDED|95.0|0.942|4.006|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.006|0.942|0.0016
71752355|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.496||||0.0022|TWO_SIDED|95.0|0.901|4.092|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.092|0.901|0.0022
71783922|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1222|TWO_SIDED|95.0|-0.4|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||3.4|-0.4|0.1222
71783923|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0289|TWO_SIDED|95.0|0.2|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6||4.1|0.2|0.0289
71783924|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0571|TWO_SIDED|95.0|-0.1|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||3.8|-0.1|0.0571
71783925|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.9||||0.0042|TWO_SIDED|95.0|0.9|4.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12||4.9|0.9|0.0042
71783926|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0423|TWO_SIDED|95.0|0.1|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||3.7|0.1|0.0423
71783927|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0174|TWO_SIDED|95.0|0.4|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12||4.1|0.4|0.0174
71783928|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.363|TWO_SIDED|95.0|-1.1|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 12||3.0|-1.1|0.3630
71836160|NCT05529966|143177920|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Visibility score||||.213464715
71836161|NCT05529966|143177920|OTHER|||||||0.213464715||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Image Quality score||||.213464715
71836162|NCT05529966|143177920|OTHER|||||||0.155899777||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Focus score||||.155899777
71836163|NCT05529966|143177920|OTHER|||||||0.055960023||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Depth Perception score||||.055960023
71836164|NCT05529966|143177920|OTHER|||||||0.000685499||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Staff Engagement score||||.000685499
71783929|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6319|TWO_SIDED|95.0|-1.6|2.6|||ANOVA|Missing data were imputed by LOCF|Missing data were imputed by LOCF|Mental Health, Month 12||2.6|-1.6|0.6319
71783930|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.8||||0.0503|TWO_SIDED|95.0|0.0|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||3.7|-0.0|0.0503
71783931|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.9||||0.3291|TWO_SIDED|95.0|-0.9|2.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12||2.8|-0.9|0.3291
71783932|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.386|TWO_SIDED|95.0|-1.2|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||3.1|-1.2|0.3860
71783933|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.0||||0.9672|TWO_SIDED|95.0|-2.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12||2.3|-2.2|0.9672
71783934|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0392|TWO_SIDED|95.0|0.1|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.1|0.1|0.0392
71836165|NCT05529966|143177920|OTHER|||||||0.004526118||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Teaching score||||.004526118
71836166|NCT05529966|143177920|OTHER|||||||0.299921137||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of En Face Confidence score||||.299921137
71836167|NCT05529966|143177920|OTHER|||||||0.368082084||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Hydrus Placement Confidence score||||.368082084
71752356|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.509||||0.0026|TWO_SIDED|95.0|0.878|4.14|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.140|0.878|0.0026
71752357|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.531||||0.0034|TWO_SIDED|95.0|0.836|4.226|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.226|0.836|0.0034
71752358|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.544||||0.004|TWO_SIDED|95.0|0.813|4.274|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.274|0.813|0.0040
71752359|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.566||||0.0051|TWO_SIDED|95.0|0.772|4.361|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.361|0.772|0.0051
71752360|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.579||||0.0058|TWO_SIDED|95.0|0.748|4.41|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.410|0.748|0.0058
71752361|NCT00083889|143008009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.602||||0.0071|TWO_SIDED|95.0|0.706|4.497|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FKSI-DRS baseline score (intercept and time since randomization are included as random effects).||4.497|0.706|0.0071
71752362|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.165|||<|0.0001|TWO_SIDED|95.0|2.234|4.095|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.095|2.234|<.0001
71752363|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.205|||<|0.0001|TWO_SIDED|95.0|2.318|4.092|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.092|2.318|<.0001
71752364|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.228|||<|0.0001|TWO_SIDED|95.0|2.358|4.097|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.097|2.358|<.0001
71891780|NCT03576144|143305246|OTHER||Slope|1.0361|STANDARD_ERROR_OF_MEAN|0.0379|||TWO_SIDED|90.0|0.9722|1.1001|||ANCOVA||Standard Error of the mean is actually standard error of slope. Based on the estimate for the slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|Dose proportionality for Cmax,ss of BI 1265162 in plasma was assessed using a power model (regression model applied to log-transformed data). The corresponding ANCOVA model included the logarithm of the dose as a covariate. No statistical hypotheses were tested in a confirmatory sense.||1.1001|0.9722|
71891781|NCT03263091|143305255|OTHER||Odds Ratio (OR)|1.582||||0.217|TWO_SIDED|95.0|0.761|3.29|||Cochran-Mantel-Haenszel|||The odds ratio along with its 95% confidence interval (CI) were calculated based on the Cochran-Mantel-Haenszel (CMH) chi-square test adjusting for the stratification factors (EPO level, International Prognostic Scoring System - Revised \[IPSS-R\] risk category and RBC transfusion burden).||3.290|0.761|0.217
71752365|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.268|||<|0.0001|TWO_SIDED|95.0|2.418|4.119|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.119|2.418|<.0001
71783935|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0151|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12||4.5|0.5|0.0151
71783936|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.3978|TWO_SIDED|95.0|-1.1|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||2.7|-1.1|0.3978
71783937|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1263|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12||3.5|-0.4|0.1263
71783938|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.016|TWO_SIDED|95.0|0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.2|0.4|0.0160
71783939|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0075|TWO_SIDED|95.0|0.7|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12||4.5|0.7|0.0075
71783940|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.699|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||2.4|-1.6|0.6990
71891782|NCT00318292|143305318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.003||95.0|-3.2|-0.7|||t-test, 2 sided|||||-0.7|-3.2|.003
71752366|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.291|||<|0.0001|TWO_SIDED|95.0|2.443|4.139|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.139|2.443|<.0001
71752367|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.331|||<|0.0001|TWO_SIDED|95.0|2.474|4.189|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.189|2.474|<.0001
71752368|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.354|||<|0.0001||95.0|2.484|4.224|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.224|2.484|<.0001
71783941|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1608|TWO_SIDED|95.0|-0.6|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24||3.5|-0.6|0.1608
71783942|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0214|TWO_SIDED|95.0|0.3|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.0|0.3|0.0214
71783943|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.00886|TWO_SIDED|95.0|0.6|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24||4.4|0.6|0.00886
71783944|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.2555|TWO_SIDED|95.0|-0.9|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||3.3|-0.9|0.2555
71783945|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4804|TWO_SIDED|95.0|-1.4|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24||2.9|-1.4|0.4804
71783946|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0276|TWO_SIDED|95.0|0.2|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||4.2|0.2|0.0276
71783947|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1285|TWO_SIDED|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24||3.5|-0.4|0.1285
71783948|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.1352|TWO_SIDED|95.0|-0.5|3.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.9|-0.5|0.1352
71783949|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2663|TWO_SIDED|95.0|-1.0|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24||3.5|-1.0|0.2663
71783950|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0164|TWO_SIDED|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||4.5|0.5|0.0164
71783951|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|3.9||||0.0002|TWO_SIDED|95.0|1.9|5.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24||5.9|1.9|0.0002
71783952|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1914|TWO_SIDED|95.0|-0.7|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||3.3|-0.7|0.1914
71783953|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.4||||0.6882|TWO_SIDED|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24||2.4|-1.6|0.6882
71783954|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.0547|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||4.0|-0.0|0.0547
71783955|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0992|TWO_SIDED|95.0|-0.3|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24||3.8|-0.3|0.0992
71783956|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0339|TWO_SIDED|95.0|0.2|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||4.4|0.2|0.0339
71783957|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3572|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36||3.1|-1.1|0.3572
71783958|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.3||||0.0211|TWO_SIDED|95.0|0.3|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.2|0.3|0.0211
71783959|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.0||||0.045|TWO_SIDED|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36||4.0|0.0|0.0450
71783960|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.171|TWO_SIDED|95.0|-0.7|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.7|-0.7|0.1710
71783961|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.2484|TWO_SIDED|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36||3.6|-0.9|0.2484
71783962|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1836|TWO_SIDED|95.0|-0.6|3.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||3.2|-0.6|0.1836
71783963|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.0||||0.3303|TWO_SIDED|95.0|-1.0|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36||2.9|-1.0|0.3303
71783964|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0299|TWO_SIDED|95.0|0.2|4.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.8|0.2|0.0299
71783965|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.1141|TWO_SIDED|95.0|-0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36||4.2|-0.4|0.1141
71752369|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.395|||<|0.0001|TWO_SIDED|95.0|2.489|4.3|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.300|2.489|<.0001
71752370|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.417|||<|0.0001|TWO_SIDED|95.0|2.486|4.348|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.348|2.486|<.0001
71783966|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.7||||0.0087|TWO_SIDED|95.0|0.7|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.7|0.0087
71783967|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.6||||0.0128|TWO_SIDED|95.0|0.6|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36||4.7|0.6|0.0128
71783968|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.5||||0.1369|TWO_SIDED|95.0|-0.5|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||3.5|-0.5|0.1369
71783969|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.5||||0.6331|TWO_SIDED|95.0|-1.5|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36||2.5|-1.5|0.6331
71783970|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0361|TWO_SIDED|95.0|0.1|4.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.3|0.1|0.0361
71783971|NCT00256750|143066701|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.1||||0.0525|TWO_SIDED|95.0|0.0|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36||4.2|-0.0|0.0525
71783972|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.015|-0.032|<0.0001
71783973|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.019|||<|0.0001|TWO_SIDED|95.0|-0.028|-0.011||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.011|-0.028|<0.0001
71783974|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.014||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.014|-0.031|<0.0001
71783975|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.035|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.||-0.017|-0.035|<0.0001
71783976|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.024|||<|0.0001|TWO_SIDED|95.0|-0.032|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.016|-0.032|<0.0001
71783977|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.029|-0.012||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.012|-0.029|<0.0001
71836168|NCT05529966|143177920|OTHER|||||||0.015036417||||||The a priori threshold for statistical significance after Bonferroni correction is \< 0.002083333|t-test, 2 sided|||Analysis of Scope Preference score||||.015036417
71836169|NCT04690673|143177921|EQUIVALENCE|Based on previous reports on the pharmacokinetics of oral paracetamol, the standard deviation of the within-subject difference in the Cmax for paracetamol was estimated to be 35% of the mean Cmax. Using this standard deviation, 10 participants were estimated to be sufficient, with a power of at least 80% (at 5% significance level). We recruited 12 volunteers to account for potential protocol violations or dropouts.|Geometric mean ratio|1.03||||0.05|TWO_SIDED|90.0|0.94|1.13||Not adjusted for multiple comparisons as the analysis was exploratory|t-test, 2 sided||Adhering|Highest paracetamol concentrations (Cmax) measured from capillary with the electrochemical method compared with measurements with mass-spectrometry.||1.13|0.94|0.05
71845403|NCT01478594|143205113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.877|||||TWO_SIDED|95.0|0.366|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.366|
71891783|NCT01552057|143305331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0988|TWO_SIDED|95.0|-0.7|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||0.06|-0.70|0.0988
71752371|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.458|||<|0.0001|TWO_SIDED|95.0|2.469|4.446|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.446|2.469|<.0001
71669113|NCT02456740|142855051|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|2.01|3.94|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).||3.94|2.01|< 0.001
71669114|NCT02456740|142855052|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|LS Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.23|-0.64|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.64|-1.23|< 0.001
71669115|NCT02456740|142855052|SUPERIORITY|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|LS Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.71|-1.12|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, (stratification factors region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.12|-1.71|< 0.001
71669116|NCT02456740|142855053|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.43|||<|0.001|TWO_SIDED|95.0|-3.51|-1.35|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.35|-3.51|< 0.001
71669117|NCT02456740|142855053|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.95|-0.77|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-0.77|-2.95|< 0.001
71669118|NCT02456740|142855054|SUPERIORITY|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.57|||<|0.001|TWO_SIDED|95.0|-3.62|-1.51|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.51|-3.62|< 0.001
71677103|NCT00356135|142872623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.67|-5.09||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|||-5.09|-14.67|<0.0001
71752372|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48|||<|0.0001|TWO_SIDED|95.0|2.455|4.505|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.505|2.455|<.0001
71752373|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.521|||<|0.0001|TWO_SIDED|95.0|2.422|4.62|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.620|2.422|<.0001
71752374|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.543|||<|0.0001|TWO_SIDED|95.0|2.399|4.687|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.687|2.399|<.0001
71752375|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.584|||<|0.0001||95.0|2.354|4.814|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)||4.814|2.354|<.0001
71752376|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.606|||<|0.0001|TWO_SIDED|95.0|2.326|4.887|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||4.887|2.326|<.0001
71891784|NCT01552057|143305332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0003|TWO_SIDED|95.0|-0.76|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.22|-0.76|0.0003
71677104|NCT00356135|142872624|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0005
71752377|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.647|||<|0.0001|TWO_SIDED|95.0|2.272|5.022|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.022|2.272|<.0001
71752378|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||<|0.0001|TWO_SIDED|95.0|2.24|5.099|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.099|2.240|<.0001
71752379|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||<|0.0001|TWO_SIDED|95.0|2.18|5.24|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.240|2.180|<.0001
71752380|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.733|||<|0.0001|TWO_SIDED|95.0|2.145|5.32|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.320|2.145|<.0001
71752381|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.773|||<|0.0001|TWO_SIDED|95.0|2.08|5.466|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.466|2.080|<.0001
71752382|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.796|||<|0.0001|TWO_SIDED|95.0|2.043|5.548|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.548|2.043|<.0001
71752383|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.836|||<|0.0001|TWO_SIDED|95.0|1.975|5.698|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.698|1.975|<.0001
71752384|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|||<|0.0001|TWO_SIDED|95.0|1.936|5.781|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.781|1.936|<.0001
71783978|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.026|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.017|-0.034|<0.0001
71783979|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.025|||<|0.0001|TWO_SIDED|95.0|-0.034|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.||-0.016|-0.034|<0.0001
71783980|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.013|-0.030|<0.0001
71783981|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.015|||<|0.0001|TWO_SIDED|95.0|-0.024|-0.007||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.||-0.007|-0.024|<0.0001
71783982|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.023|||<|0.0001|TWO_SIDED|95.0|-0.031|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.015|-0.031|<0.0001
71783983|NCT00256750|143066702|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|-0.021|||<|0.0001|TWO_SIDED|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24||-0.013|-0.030|<0.0001
71845404|NCT01478594|143205113|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.275|||||TWO_SIDED|95.0|0.614|2.646|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.646|0.614|
71677105|NCT00356135|142872624|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||<0.0001
71836170|NCT04850807|143177934|SUPERIORITY||average marginal effect|-0.4|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-6.9|6.0|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|6.0|-6.9|<0.05
71836171|NCT04850807|143177935|SUPERIORITY||Average Marginal Effect|0.1|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|95.0|-0.06|0.26|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI model), baseline CMAI (exclusive to ARBS model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.26|-0.06|<0.05
71836172|NCT04850807|143177936|SUPERIORITY||average marginal effect|4.0|STANDARD_ERROR_OF_MEAN|3.2|<|0.05|TWO_SIDED|95.0|-2.3|10.2|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|10.2|-2.3|<0.05
71836173|NCT04850807|143177937|SUPERIORITY||average marginal effect|-1.4|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-8.5|5.6|||Differences-in-Differences regression||||"Results are adjusted for baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~The model includes a random intercept for nursing home."|5.6|-8.5|<0.05
71836174|NCT04850807|143177938|SUPERIORITY||average marginal effect|-4.8|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-9.8|0.1|||Differences-in-Differences regression||||"Fixed effect covariates: baseline medication use, age, sex, race, activities of daily living score, cognitive function score, psychotic diagnosis, depression, anxiety, dementia, asthma, ARBS score, treatment group.~Random effects: random intercept for nursing home Imputed Outcomes: 37 Control Follow-Up , 35 Treatment Follow-Up"|0.1|-9.8|<0.05
71836175|NCT04850807|143177940|SUPERIORITY||average marginal effect|-0.31|||<|0.05|TWO_SIDED|95.0|-1.03|0.41|||Differences-in-Differences regression||||"Fixed effect covariates: age, sex, race, activities of daily living score, cognitive function score, psychotic disorder, bipolar disease, depression, anxiety, dementia, alzheimer's diagnosis, antidepressant use, antianxietal use, antipsychotic use, history of heart failure, baseline ARBS (exclusive to CMAI/PHQ-9 model), baseline CMAI (exclusive to ARBS/PHQ-9 model), indicator of baseline/follow-up score, treatment group, interaction of treatment group and baseline/follow-up score.~Random effects: random intercept for nursing home, random intercept for the interaction of baseline/follow-up measure and nursing home, and random intercept for individual.~Imputed Outcomes: 37 Control Follow-Up (Both CMAI and ARBS), 37 Treatment Follow-Up (ABRS), 35 Treatment Follow-Up (CMAI)"|0.41|-1.03|<0.05
71836176|NCT03328702|143177957|SUPERIORITY|Repeated measures ANOVA|Mean Difference (Net)|0.01|||<|0.05|TWO_SIDED|||||Repeated measures ANOVA, N=4|ANOVA|Repeated measures ANOVA||The null hypothesis is that there is no difference in total pharyngeal transit time with the use of CPAP||||<0.05
71836177|NCT04833777|143177958|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836178|NCT04833777|143177959|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836179|NCT04833777|143177960|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836180|NCT04833777|143177961|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836181|NCT04833777|143177962|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836182|NCT04833777|143177963|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836183|NCT04833777|143177964|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71752385|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.899||||0.0002|TWO_SIDED|95.0|1.866|5.933|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||5.933|1.866|0.0002
71752386|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.922||||0.0002|TWO_SIDED|95.0|1.826|6.018|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.018|1.826|0.0002
71836184|NCT04833777|143177965|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71836185|NCT04833777|143177966|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71836186|NCT04833777|143177967|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71836187|NCT04833777|143177968|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71836188|NCT04833777|143177969|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71677106|NCT00356135|142872624|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0150
71836189|NCT04833777|143177970|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71836190|NCT04833777|143177971|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71836191|NCT04833777|143177973|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71836192|NCT04833777|143177974|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71891785|NCT01552057|143305333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0012|TWO_SIDED|95.0|-0.71|-0.18||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.18|-0.71|0.0012
71752387|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.962||||0.0004|TWO_SIDED|95.0|1.753|6.172|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.172|1.753|0.0004
71677107|NCT00356135|142872624|SUPERIORITY_OR_OTHER|||||||0.0152||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0152
71752388|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.985||||0.0006||95.0|1.712|6.258|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.258|1.712|0.0006
71752389|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026||||0.001|TWO_SIDED|95.0|1.638|6.413|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.413|1.638|0.0010
71752390|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.048||||0.0012|TWO_SIDED|95.0|1.597|6.5|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.500|1.597|0.0012
71752391|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.089||||0.0018|TWO_SIDED|95.0|1.521|6.656|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.656|1.521|0.0018
71752392|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.111||||0.0022|TWO_SIDED|95.0|1.479|6.743|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.743|1.479|0.0022
71752393|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.152||||0.0031|TWO_SIDED|95.0|1.403|6.901|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.901|1.403|0.0031
71783984|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4498|TWO_SIDED|95.0|-1.2|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||2.7|-1.2|0.4498
71783985|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0584|TWO_SIDED|95.0|-0.1|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6||3.9|-0.1|0.0584
71783986|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.1||||0.1595|TWO_SIDED|95.0|-0.5|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||2.7|-0.5|0.1595
71783987|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.7||||0.0457|TWO_SIDED|95.0|0.0|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6||3.3|0.0|0.0457
71783988|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.3||||0.1729|TWO_SIDED|95.0|-0.6|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||3.2|-0.6|0.1729
71783989|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4209|TWO_SIDED|95.0|-1.1|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12||2.7|-1.1|0.4209
71783990|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0526|TWO_SIDED|95.0|0.0|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.2|-0.0|0.0526
71783991|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0077|TWO_SIDED|95.0|0.6|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12||3.9|0.6|0.0077
71783992|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.1849|TWO_SIDED|95.0|-0.6|3.4|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||3.4|-0.6|0.1849
71783993|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|0.8||||0.4633|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24||2.8|-1.3|0.4633
71783994|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.4||||0.0971|TWO_SIDED|95.0|-0.3|3.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.0|-0.3|0.0971
71783995|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.2||||0.0102|TWO_SIDED|95.0|0.5|3.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24||3.8|0.5|0.0102
71783996|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|2.5||||0.0186|TWO_SIDED|95.0|0.4|4.5|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.5|0.4|0.0186
71783997|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.9||||0.0775|TWO_SIDED|95.0|-0.2|4.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36||4.0|-0.2|0.0775
71836193|NCT04172441|143177977|SUPERIORITY||Difference in LS means|-5.21||||0.0037|TWO_SIDED|95.0|-8.29|-2.13|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: weighted mean IV GIR in the last 12 hours of treatment with dasiglucagon = weighted mean IV GIR in the last 12 hours of treatment with placebo||-2.13|-8.29|0.0037
71891786|NCT01552057|143305334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.35||||0.0073|TWO_SIDED|95.0|-9.26|-1.45||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.45|-9.26|0.0073
71783998|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.6||||0.0768|TWO_SIDED|95.0|-0.2|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||3.3|-0.2|0.0768
71783999|NCT00256750|143066703|SUPERIORITY_OR_OTHER||Mean Difference (Final Value)|1.2||||0.1876|TWO_SIDED|95.0|-0.6|2.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36||2.9|-0.6|0.1876
71784000|NCT00256750|143066705|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|4.2|||||TWO_SIDED|97.3|-1.3|10.1||||||Month 24||10.1|-1.3|
71784001|NCT00256750|143066705|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.6|||||TWO_SIDED|97.3|-2.2|9.6||||||Month 24||9.6|-2.2|
71784002|NCT00256750|143066705|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.3|||||TWO_SIDED|97.3|-2.9|9.8||||||Month 36||9.8|-2.9|
71784003|NCT00256750|143066705|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.5|||||TWO_SIDED|97.3|-2.8|10.0||||||||10.0|-2.8|
71891787|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.34||||0.0049|TWO_SIDED|95.0|1.32|7.35||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Physical Functioning||7.35|1.32|0.0049
71891788|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.76||||0.0003|TWO_SIDED|95.0|3.57|11.94||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Physical||11.94|3.57|0.0003
71752394|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.174||||0.0037||95.0|1.36|6.988|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||6.988|1.360|0.0037
71752395|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.215||||0.0048|TWO_SIDED|95.0|1.283|7.147|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.147|1.283|0.0048
71752396|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.237||||0.0056|TWO_SIDED|95.0|1.24|7.235|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.235|1.240|0.0056
71752397|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.278||||0.0071|TWO_SIDED|95.0|1.162|7.394|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.394|1.162|0.0071
71752398|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.0081|TWO_SIDED|95.0|1.119|7.482|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.482|1.119|0.0081
71752399|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.341||||0.0099|TWO_SIDED|95.0|1.041|7.642|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.642|1.041|0.0099
71752400|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.364||||0.0111|TWO_SIDED|95.0|0.997|7.73|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.730|0.997|0.0111
71752401|NCT00083889|143008010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.404||||0.0133|TWO_SIDED|95.0|0.918|7.89|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).||7.890|0.918|0.0133
71752402|NCT00083889|143008011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5404|||<|0.0001|TWO_SIDED|95.0|0.4532|0.6444||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6444|0.4532|<0.0001
71752403|NCT00083889|143008011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5418|||<|1e-05|TWO_SIDED|95.0|0.4536|0.6473||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) \> or \<= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN-α).||0.6473|0.4536|<.00001
71784004|NCT00256750|143066706|SUPERIORITY_OR_OTHER||Difference in Percent|5.9|||||TWO_SIDED|95.0|-1.0|12.8||||||Month 12||12.8|-1.0|
71784005|NCT00256750|143066706|SUPERIORITY_OR_OTHER||Difference in Percent|11.5|||||TWO_SIDED|95.0|4.2|18.9||||||Month 12||18.9|4.2|
71784006|NCT00256750|143066706|SUPERIORITY_OR_OTHER||Difference in Percent|1.8|||||TWO_SIDED|95.0|-5.5|9.1||||||Month 24||9.1|-5.5|
71784007|NCT00256750|143066706|SUPERIORITY_OR_OTHER||Difference in Percent|9.8|||||TWO_SIDED|95.0|1.9|17.6||||||Month 24||17.6|1.9|
71784008|NCT00256750|143066706|SUPERIORITY_OR_OTHER||Difference in Percent|0.9|||||TWO_SIDED|95.0|-6.6|8.4||||||Month 36||8.4|-6.6|
71784009|NCT00256750|143066706|SUPERIORITY_OR_OTHER||Difference in Percent|8.4|||||TWO_SIDED|95.0|0.4|16.4||||||Month 36||16.4|0.4|
71836194|NCT04172441|143177978|SUPERIORITY||Difference in LS means|-30.93||||0.0238|TWO_SIDED|95.0|-56.8|-5.05|||Mixed Models Analysis|A mixed model was used, with treatment and period as fixed effects and patient as random effect.|The comparison was in the direction of dasiglucagon minus placebo.|Null hypothesis: Total amount of carbohydrates administered (regardless of route) per day in patients treated with dasiglucagon = total amount of carbohydrates administered (regardless of route) per day in patients treated with placebo||-5.05|-56.80|0.0238
71784010|NCT01197560|143066710|SUPERIORITY|||||||0.079|||||||Fisher Exact|||Pertains to all participants; row 1||||0.079
71784011|NCT01197560|143066710|SUPERIORITY|||||||0.279|||||||Fisher Exact|||Pertains to GCB Subtype; row 2||||0.279
71784012|NCT01197560|143066710|SUPERIORITY|||||||0.179|||||||Fisher Exact|||Pertains to non-GCB Sub-type; row 3||||0.179
71784013|NCT01197560|143066711|SUPERIORITY|||||||0.091|||||||Fisher Exact|||Pertains to all participants||||0.091
71784014|NCT01197560|143066712|SUPERIORITY|||||||0.109|||||||Fisher Exact|||||||0.109
71784015|NCT01197560|143066713|SUPERIORITY|||||||0.16|||||||Fisher Exact|||Pertains to all participants; row 1||||0.160
71784016|NCT01197560|143066714|SUPERIORITY|||||||0.529|||||||Log Rank|||||||0.529
71784017|NCT01197560|143066715|SUPERIORITY|||||||0.972|||||||Log Rank|||||||0.972
71784018|NCT01197560|143066716|SUPERIORITY|||||||0.02|||||||Log Rank|||||||0.020
71752404|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.486|||<|0.0001|TWO_SIDED|95.0|3.852|7.119|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).||7.119|3.852|<.0001
71752405|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.535|||<|0.0001|TWO_SIDED|95.0|3.955|7.115|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.115|3.955|<.0001
71752406|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.562|||<|0.0001|TWO_SIDED|95.0|4.0|7.124|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.124|4.000|<.0001
71752407|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.611|||<|0.0001|TWO_SIDED|95.0|4.061|7.162|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.162|4.061|<.0001
71752408|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.639|||<|0.0001|TWO_SIDED|95.0|4.083|7.195|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.195|4.083|<.0001
71752409|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.688|||<|0.0001|TWO_SIDED|95.0|4.1|7.276|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.276|4.100|<.0001
71752410|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.715|||<|0.0001|TWO_SIDED|95.0|4.098|7.333|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.333|4.098|<.0001
71752411|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.764|||<|0.0001|TWO_SIDED|95.0|4.075|7.454|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.454|4.075|<.0001
71752412|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.792|||<|0.0001|TWO_SIDED|95.0|4.053|7.531|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.531|4.053|<.0001
71752413|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.841|||<|0.0001|TWO_SIDED|95.0|3.998|7.684|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.684|3.998|<.0001
71752414|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.868|||<|0.0001|TWO_SIDED|95.0|3.96|7.777|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.777|3.960|<.0001
71752415|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.917|||<|0.0001|TWO_SIDED|95.0|3.88|7.955|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||7.955|3.880|<.0001
71752416|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.945|||<|0.0001|TWO_SIDED|95.0|3.83|8.06|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.060|3.830|<.0001
71752417|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.994|||<|0.0001|TWO_SIDED|95.0|3.731|8.257|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.257|3.731|<.0001
71784019|NCT01197560|143066717|SUPERIORITY|||||||0.211|||||||Log Rank|||||||0.211
71784020|NCT04659161|143066740|SUPERIORITY||LS mean difference|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.9|-5.2|||Mixed Model for Repeated Measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-5.2|-13.9|<0.0001
71752418|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.021|||<|0.0001|TWO_SIDED|95.0|3.672|8.37|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.370|3.672|<.0001
71677108|NCT00356135|142872624|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0153
71752419|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.071|||<|0.0001|TWO_SIDED|95.0|3.56|8.581|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.581|3.560|<.0001
71752420|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.098|||<|0.0001|TWO_SIDED|95.0|3.495|8.701|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.701|3.495|<.0001
71752421|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.147|||<|0.0001|TWO_SIDED|95.0|3.373|8.921|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||8.921|3.373|<.0001
71752422|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.174|||<|0.0001|TWO_SIDED|95.0|3.303|9.045|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.045|3.303|<.0001
71752423|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.224|||<|0.0001|TWO_SIDED|95.0|3.174|9.273|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.273|3.174|<.0001
71752424|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.251||||0.0001|TWO_SIDED|95.0|3.101|9.401|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.401|3.101|0.0001
71752425|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.0002|TWO_SIDED|95.0|2.966|9.634|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.634|2.966|0.0002
71752426|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.327||||0.0003|TWO_SIDED|95.0|2.89|9.765|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||9.765|2.890|0.0003
71752427|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.377||||0.0006|TWO_SIDED|95.0|2.751|10.002|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.002|2.751|0.0006
71784021|NCT04659161|143066741|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
71784022|NCT04659161|143066742|SUPERIORITY|||||||0.0055|||||||Mixed Model Repeated Measures|||||||0.0055
71784023|NCT04659161|143066743|SUPERIORITY|||||||0.0022|||||||Mixed Model for Repeated Measures|||||||0.0022
71784024|NCT04659161|143066744|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
71784025|NCT04659161|143066745|SUPERIORITY||||||<|0.0001|||||||Mixed Model for Repeated Measures|||||||<0.0001
71784026|NCT02197130|143066754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.192||0.2033|TWO_SIDED|90.0|-0.45|3.49|||MMRM|MMRM: A linear mixed-effect repeated measures model||||3.49|-0.45|0.2033
71784027|NCT02197130|143066754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|1.118||0.7549|TWO_SIDED|90.0|-2.2|1.5|||MMRM|||||1.50|-2.20|0.7549
71784028|NCT02197130|143066766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|0.515||0.003|TWO_SIDED|90.0|0.69|2.39|||MMRM|||Week 13||2.39|0.69|0.0030
71784029|NCT02197130|143066766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.491||0.4656|TWO_SIDED|90.0|-0.45|1.17|||MMRM|||Week 13||1.17|-0.45|0.4656
71784030|NCT02197130|143066766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21|STANDARD_ERROR_OF_MEAN|0.492||0.0149|TWO_SIDED|90.0|0.39|2.02|||MMRM|||Week 26||2.02|0.39|0.0149
71784031|NCT02197130|143066766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8233|TWO_SIDED|90.0|-0.66|0.86|||MMRM|||Week 26||0.86|-0.66|0.8233
71784032|NCT02197130|143066768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.148||0.0181|TWO_SIDED|90.0|0.11|0.6|||MMRM|||Week 13||0.60|0.11|0.0181
71784033|NCT02197130|143066768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7133|TWO_SIDED|90.0|-0.18|0.28|||MMRM|||Week 13||0.28|-0.18|0.7133
71784034|NCT02197130|143066768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.163||0.4657|TWO_SIDED|90.0|-0.15|0.39|||MMRM|||Week 26||0.39|-0.15|0.4657
71784035|NCT02197130|143066768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.15||0.8339|TWO_SIDED|90.0|-0.22|0.28|||MMRM|||Week 26||0.28|-0.22|0.8339
71752428|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.404||||0.0008|TWO_SIDED|95.0|2.673|10.135|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.135|2.673|0.0008
71752429|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.453||||0.0013|TWO_SIDED|95.0|2.53|10.376|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.376|2.530|0.0013
71752430|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48||||0.0016|TWO_SIDED|95.0|2.451|10.51|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.510|2.451|0.0016
71752431|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0025|TWO_SIDED|95.0|2.306|10.754|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.754|2.306|0.0025
71752432|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.557||||0.003|TWO_SIDED|95.0|2.224|10.889|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||10.889|2.224|0.0030
71752433|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.606||||0.0043|TWO_SIDED|95.0|2.077|11.135|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.135|2.077|0.0043
71752434|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.634||||0.0051|TWO_SIDED|95.0|1.995|11.272|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.272|1.995|0.0051
71752435|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.683||||0.0068|TWO_SIDED|95.0|1.847|11.519|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.519|1.847|0.0068
71752436|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.71||||0.0079|TWO_SIDED|95.0|1.764|11.657|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.657|1.764|0.0079
71752437|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.759||||0.01|TWO_SIDED|95.0|1.613|11.905|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||11.905|1.613|0.0100
71752438|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.787||||0.0114|TWO_SIDED|95.0|1.53|12.043|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.043|1.530|0.0114
71752439|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.836||||0.0141|TWO_SIDED|95.0|1.378|12.293|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.293|1.378|0.0141
71752440|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.863||||0.0157|TWO_SIDED|95.0|1.294|12.432|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.432|1.294|0.0157
71752441|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.912||||0.0189|TWO_SIDED|95.0|1.142|12.683|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.683|1.142|0.0189
71784036|NCT02320669|143066769|SUPERIORITY||Cox Proportional Hazard|1.083|||<|0.05|TWO_SIDED|95.0|0.82|1.432|||Regression, Cox|||||1.432|.82|<.05
71784037|NCT01600638|143066778|OTHER||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|||||||||||||
71784038|NCT01600638|143066779|OTHER||sucess proportion|0.7823|||||TWO_SIDED|95.0|0.614|0.951||||||||0.951|0.614|
71784039|NCT03338998|143066782|SUPERIORITY||Geo-mean ratio|1.05||||0.585|TWO_SIDED|90.0|0.717|1.535|||ANCOVA|||||1.535|0.717|0.585
71784040|NCT02342327|143066809|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.55|1.22||||||Hazard ratio for time to lapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.22|0.55|
71677109|NCT00356135|142872624|SUPERIORITY_OR_OTHER|||||||0.0018||95.0||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient|||||||0.0018
71677110|NCT03963232|142872626|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.32|-1.32|||Mixed Models Analysis|||||-1.32|-2.32|<.0001
71752442|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.94||||0.0208|TWO_SIDED|95.0|1.057|12.822|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||12.822|1.057|0.0208
71752443|NCT00083889|143008012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.989||||0.0244|TWO_SIDED|95.0|0.904|13.074|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).||13.074|0.904|0.0244
71752444|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.459|||<|0.0001|TWO_SIDED|95.0|0.805|2.114|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.114|0.805|<.0001
71752445|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.453|||<|0.0001|TWO_SIDED|95.0|0.827|2.079|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.079|0.827|<.0001
71752446|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45|||<|0.0001|TWO_SIDED|95.0|0.837|2.063|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.063|0.837|<.0001
71752447|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.444|||<|0.0001|TWO_SIDED|95.0|0.847|2.041|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.041|0.847|<.0001
71752448|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|||<|0.0001|TWO_SIDED|95.0|0.848|2.032|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.032|0.848|<.0001
71752449|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.434|||<|0.0001|TWO_SIDED|95.0|0.844|2.024|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.024|0.844|<.0001
71752450|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.431|||<|0.0001|TWO_SIDED|95.0|0.838|2.023|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.023|0.838|<.0001
71752451|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.424|||<|0.0001|TWO_SIDED|95.0|0.819|2.029|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.029|0.819|<.0001
71752452|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.421|||<|0.0001|TWO_SIDED|95.0|0.805|2.037|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.037|0.805|<.0001
71752453|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.415|||<|0.0001|TWO_SIDED|95.0|0.774|2.056|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.056|0.774|<.0001
71784041|NCT02342327|143066810|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.42|1.06||||||Hazard ratio for time to relapse to smoking in the group switched to non-menthol cigarettes relative to the group continuing to smoke menthol cigarettes||1.06|0.42|
71784042|NCT00980057|143066844|NON_INFERIORITY|The non-inferiority margin was 12%.||||||0.0002|||||||Farrington-Manning test of two ind. prop|||||||0.0002
71784043|NCT00980057|143066845|SUPERIORITY|The pre-specified minimum objective performance criteria was 0.82|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71784044|NCT00980057|143066847|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71784045|NCT00980057|143066848|NON_INFERIORITY|The non-inferiority margin is 15|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71784046|NCT00980057|143066849|NON_INFERIORITY|The non-inferiority margin is 2.5||||||0.0009|||||||t-test, 1 sided|||||||0.0009
71784047|NCT00980057|143066850|NON_INFERIORITY|The non-inferiority margin is 0.3|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71784048|NCT00980057|143066851|NON_INFERIORITY|The non-inferiority margin is 30||||||0.0002|||||||t-test, 1 sided|||||||0.0002
71669119|NCT02456740|142855054|SUPERIORITY|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-2.22|||<|0.001|TWO_SIDED|95.0|-3.28|-1.16|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.||-1.16|-3.28|< 0.001
71669120|NCT00931528|142855088|SUPERIORITY_OR_OTHER||Difference in percentages|5.0||||0.49|TWO_SIDED|95.0|1.0|9.0|||Chi-squared|||Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.||9|1|0.49
71669121|NCT00931528|142855088|SUPERIORITY|||||||0.2386|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.2386
71669122|NCT00931528|142855088|SUPERIORITY|||||||0.7908|||||||Regression, Linear|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.||||0.7908
71669123|NCT00931528|142855088|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.0467
71784049|NCT00980057|143066852|NON_INFERIORITY|The non-inferiority margin is 5.1||||||0.002|||||||t-test, 1 sided|||||||0.002
71784050|NCT01315678|143066863|SUPERIORITY||Cox Proportional Hazard|1.51||||0.0286|TWO_SIDED|95.0|1.07|2.13|||Regression, Cox|||Stratified Cox proportional hazards model||2.13|1.07|0.0286
71784051|NCT01315678|143066864|SUPERIORITY||Cox Proportional Hazard|1.12||||0.6031|TWO_SIDED|95.0|0.76|1.66|||Regression, Cox|||||1.66|0.76|0.6031
71669124|NCT00931528|142855088|SUPERIORITY|||||||0.0068|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX vs. N0)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.0068
71669125|NCT00931528|142855089|SUPERIORITY|||||||0.93|||||||Chi-squared|2-sided significance level = 0.05||Year 1||||0.93
71669126|NCT00931528|142855089|SUPERIORITY|||||||0.58|||||||Chi-squared|2-sided significance level = 0.05||Year 2||||0.58
71669127|NCT00931528|142855089|SUPERIORITY|||||||0.9501|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.9501
71669128|NCT00931528|142855089|SUPERIORITY|||||||0.102|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.1020
71677111|NCT03963232|142872627|SUPERIORITY||Odds Ratio (OR)|2.674|||<|0.0001|TWO_SIDED|95.0|2.01|3.557|||GLIMMIX|||30% responder||3.557|2.010|<.0001
71677112|NCT03963232|142872627|SUPERIORITY||Odds Ratio (OR)|2.481|||<|0.0001|TWO_SIDED|95.0|1.869|3.293|||GLIMMIX|||50% responder||3.293|1.869|<.0001
71752454|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.411|||<|0.0001|TWO_SIDED|95.0|0.753|2.069|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.069|0.753|<.0001
71784052|NCT01315678|143066865|SUPERIORITY||Cox Proportional Hazard|0.84||||0.4861|TWO_SIDED|95.0|0.49|1.44|||Regression, Cox|||||1.44|0.49|0.4861
71784053|NCT00004978|143066873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.55|TWO_SIDED|95.0|0.75|1.16||P-value is 2-sided using an alpha of .05.|Regression, Cox|Hazard ratio is from unadjusted proportional hazards regression model.|HR is for rIL-2 vs control.|||1.16|0.75|.55
71784054|NCT00004978|143066874|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.62|TWO_SIDED|95.0|0.74|1.2|||Regression, Cox|||||1.20|0.74|.62
71784055|NCT00004978|143066875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.42|TWO_SIDED|95.0|0.69|1.17|||Regression, Cox|||||1.17|0.69|.42
71784056|NCT00004978|143066876|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.41|TWO_SIDED|95.0|0.73|1.14|||Regression, Cox|||||1.14|0.73|.41
71784057|NCT00004978|143066877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|159.0|||||TWO_SIDED|95.0|145.0|174.0|||||treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits|||174|145|
71836195|NCT04674358|143178002|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|1.67|4.14||||||||4.14|1.67|
71836196|NCT03648840|143178003|OTHER||||||<|0.2|||||||t-test, 2 sided|||2-tailed, unpaired T-test||||<0.2
71836197|NCT03703700|143178011|OTHER||Risk Ratio (RR)|1.23||||0.042|TWO_SIDED|95.0|1.01|1.5|||Chi-squared|||||1.50|1.01|0.042
71836198|NCT03703700|143178012|OTHER|||||||0.781|||||||Wilcoxon (Mann-Whitney)|||||||0.781
71836199|NCT03703700|143178013|OTHER|||||||0.609|||||||Wilcoxon (Mann-Whitney)|||||||0.609
71677113|NCT03963232|142872627|SUPERIORITY||Odds Ratio (OR)|2.824|||<|0.0001|TWO_SIDED|95.0|2.007|3.972|||GLIMMIX|||75% responder||3.972|2.007|<.0001
71752455|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.405|||<|0.0001|TWO_SIDED|95.0|0.711|2.099|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.099|0.711|<.0001
71752456|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.402||||0.0001|TWO_SIDED|95.0|0.685|2.119|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.119|0.685|0.0001
71752457|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.396||||0.0003|TWO_SIDED|95.0|0.634|2.157|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.157|0.634|0.0003
71752458|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.392||||0.0005|TWO_SIDED|95.0|0.604|2.18|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.180|0.604|0.0005
71752459|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.386||||0.0012|TWO_SIDED|95.0|0.547|2.225|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.225|0.547|0.0012
71752460|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.383||||0.0018|TWO_SIDED|95.0|0.514|2.252|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.252|0.514|0.0018
71752461|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.376||||0.0035|TWO_SIDED|95.0|0.451|2.301|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.301|0.451|0.0035
71752462|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.373||||0.0049|TWO_SIDED|95.0|0.416|2.33|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.330|0.416|0.0049
71752463|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.367||||0.0084|TWO_SIDED|95.0|0.35|2.383|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.383|0.350|0.0084
71752464|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.363||||0.011|TWO_SIDED|95.0|0.313|2.414|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.414|0.313|0.0110
71752465|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.357||||0.0168|TWO_SIDED|95.0|0.245|2.47|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.470|0.245|0.0168
71752466|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.354||||0.0208|TWO_SIDED|95.0|0.206|2.501|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.501|0.206|0.0208
71784058|NCT00004978|143066879|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.94||||0.07|TWO_SIDED|95.0|0.88|1.0|||Regression, Cox|Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.||||1.00|0.88|.07
71784059|NCT00004978|143066880|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.003|TWO_SIDED|95.0|1.07|1.41|||Regression, Cox||HR (IL-2 vs control) for first grade 4 event, ITT analysis.|||1.41|1.07|.003
71784060|NCT00004978|143066881|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||Chi-squared|||||||.97
71784061|NCT00004978|143066882|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.74|TWO_SIDED|95.0|0.76|1.22|||Regression, Cox|||||1.22|0.76|.74
71836200|NCT03703700|143178014|OTHER|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||||||0.528
71836201|NCT03703700|143178015|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.880
71836202|NCT03703700|143178016|OTHER|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||||||0.289
71752467|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.348||||0.0293|TWO_SIDED|95.0|0.136|2.559|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.559|0.136|0.0293
71836203|NCT03703700|143178017|OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
71836204|NCT03703700|143178018|OTHER|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||||||0.163
71836205|NCT03703700|143178019|OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||||||0.197
71836206|NCT03703700|143178020|OTHER|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||||||0.178
71836207|NCT03703700|143178021|OTHER|||||||0.549|||||||Wilcoxon (Mann-Whitney)|||||||0.549
71752468|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.344||||0.0348|TWO_SIDED|95.0|0.096|2.592|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.592|0.096|0.0348
71752469|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.338||||0.0459|TWO_SIDED|95.0|0.024|2.652|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.652|0.024|0.0459
71752470|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.335||||0.0528|TWO_SIDED|95.0|-0.016|2.685|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.685|-0.016|0.0528
71752471|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.328||||0.0663|TWO_SIDED|95.0|-0.09|2.746|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.746|-0.090|0.0663
71752472|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.325||||0.0744|TWO_SIDED|95.0|-0.131|2.78|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.780|-0.131|0.0744
71752473|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.319||||0.0898|TWO_SIDED|95.0|-0.205|2.842|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.842|-0.205|0.0898
71752474|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.315||||0.0988|TWO_SIDED|95.0|-0.246|2.877|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.877|-0.246|0.0988
71752475|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.309||||0.1156|TWO_SIDED|95.0|-0.321|2.94|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.940|-0.321|0.1156
71752476|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.306||||0.1252|TWO_SIDED|95.0|-0.363|2.975|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||2.975|-0.363|0.1252
71752477|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1429|TWO_SIDED|95.0|-0.439|3.038|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.038|-0.439|0.1429
71752478|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.296||||0.1529|TWO_SIDED|95.0|-0.481|3.074|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.074|-0.481|0.1529
71752479|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.1711|TWO_SIDED|95.0|-0.558|3.138|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.138|-0.558|0.1711
71752480|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.1813|TWO_SIDED|95.0|-0.6|3.173|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.173|-0.600|0.1813
71669129|NCT00931528|142855089|SUPERIORITY|||||||0.1855|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[none\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.1855
71669130|NCT00931528|142855089|SUPERIORITY|||||||0.5739|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.||||0.5739
71669131|NCT00931528|142855089|SUPERIORITY|||||||0.0422|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.||||0.0422
71669132|NCT00931528|142855089|SUPERIORITY|||||||0.5237|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.||||0.5237
71669133|NCT00931528|142855089|SUPERIORITY|||||||0.477|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (\> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics \[N stage (NX)\] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.||||0.4770
71669134|NCT00931528|142855090|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.97
71669135|NCT00931528|142855090|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.99
71752481|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.1998|TWO_SIDED|95.0|-0.677|3.238|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.238|-0.677|0.1998
71669136|NCT00931528|142855090|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.24
71752482|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277||||0.21|TWO_SIDED|95.0|-0.72|3.273|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.273|-0.720|0.2100
71752483|NCT00083889|143008013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.2283|TWO_SIDED|95.0|-0.797|3.338|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).||3.338|-0.797|0.2283
71752484|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.214|||<|0.0001|TWO_SIDED|95.0|0.719|1.708|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.708|0.719|<.0001
71669137|NCT00931528|142855091|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.70
71669138|NCT00931528|142855091|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.65
71669139|NCT00931528|142855091|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|Significance level = 0.05||||||0.72
71752485|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.216|||<|0.0001|TWO_SIDED|95.0|0.729|1.703|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.703|0.729|<.0001
71752486|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.217|||<|0.0001|TWO_SIDED|95.0|0.731|1.704|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.704|0.731|<.0001
71836208|NCT03703700|143178022|OTHER||Risk Ratio (RR)|1.19||||0.035|TWO_SIDED|95.0|1.01|1.4|||Chi-squared|||||1.40|1.01|0.035
71836209|NCT03703700|143178023|OTHER||Risk Ratio (RR)|1.18||||0.034|TWO_SIDED|95.0|1.01|1.37|||Chi-squared|||||1.37|1.01|0.034
71836210|NCT03703700|143178024|OTHER||Risk Ratio (RR)|1.22||||0.022|TWO_SIDED|95.0|1.03|1.45|||Chi-squared|||||1.45|1.03|0.022
71836211|NCT03703700|143178025|OTHER||Risk Ratio (RR)|0.94||||0.707|TWO_SIDED|95.0|0.68|1.3|||Chi-squared|||||1.30|0.68|0.707
71836212|NCT03703700|143178026|OTHER||Risk Ratio (RR)|0.97||||0.878|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.878
71836213|NCT03703700|143178027|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.564
71836214|NCT03703700|143178027|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.417
71891789|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.67||||0.0002|TWO_SIDED|95.0|2.76|8.59||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Bodily Pain||8.59|2.76|0.0002
71891790|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25||||0.0192|TWO_SIDED|95.0|0.53|5.96||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||General Health||5.96|0.53|0.0192
71891791|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7||||0.0002|TWO_SIDED|95.0|3.15|10.25||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Vitality||10.25|3.15|0.0002
71891792|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.04||||0.0014|TWO_SIDED|95.0|2.74|11.34||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Social Functioning||11.34|2.74|0.0014
71891793|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12||||0.0002|TWO_SIDED|95.0|4.41|13.83||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Emotional||13.83|4.41|0.0002
71669140|NCT00931528|142855092|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.14
71669141|NCT00931528|142855092|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.64
71669142|NCT00931528|142855092|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.18
71669143|NCT00931528|142855093|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.67
71836215|NCT03703700|143178028|OTHER|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Singleton||||0.985
71836216|NCT03703700|143178028|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Twin||||0.157
71836217|NCT03703700|143178029|OTHER||Risk Ratio (RR)|1.07||||0.789|TWO_SIDED|95.0|0.65|1.78|||Chi-squared|||||1.78|0.65|0.789
71836218|NCT03703700|143178030|OTHER||Risk Ratio (RR)|1.09||||0.769|TWO_SIDED|95.0|0.61|1.94|||Chi-squared|||||1.94|0.61|0.769
71836219|NCT03703700|143178031|OTHER||Risk Ratio (RR)|0.41||||0.59|TWO_SIDED|95.0|0.04|4.45|||Fisher Exact|||||4.45|0.04|0.590
71836220|NCT03703700|143178032|OTHER||Risk Ratio (RR)|2.04||||0.465|TWO_SIDED|95.0|0.4|10.39|||Fisher Exact|||||10.39|0.40|0.465
71836221|NCT02991534|143178122|SUPERIORITY||Odds Ratio (OR)|1.09||||0.003|TWO_SIDED|95.0|1.03|1.152|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.152|1.030|.003
71836222|NCT02991534|143178123|SUPERIORITY||Odds Ratio (OR)|1.0||||0.91|TWO_SIDED|95.0|0.976|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|0.976|0.91
71836223|NCT02991534|143178124|SUPERIORITY||Odds Ratio (OR)|1.06||||0.265|TWO_SIDED|95.0|0.959|1.165|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.165|.959|.265
71836224|NCT02991534|143178125|SUPERIORITY||Odds Ratio (OR)|1.01||||0.015|TWO_SIDED|95.0|1.002|1.022|||Non-linear model with Logit|Non-linear model with Logit Link Function with Robust Standard Errors||||1.022|1.002|0.015
71836225|NCT03978871|143178187|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<0.001
71836226|NCT03978871|143178188|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.023|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.023
71669144|NCT00931528|142855093|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.98
71669145|NCT00931528|142855093|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.96
71669146|NCT00931528|142855094|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|Significance level = 0.05||Week 30||||0.86
71669147|NCT00931528|142855094|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Significance level = 0.05||Year 1||||0.93
71669148|NCT00931528|142855094|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|Significance level = 0.05||Year 2||||0.52
71669149|NCT01321749|142855205|SUPERIORITY_OR_OTHER||||||<|0.05||5.0|||||Log Rank|||||||<0.05
71836227|NCT03978871|143178188|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.034|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.034
71836228|NCT03978871|143178189|SUPERIORITY|The threshold for statistical significance was p = 0.0.5|||||<|0.001|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||<.001
71891794|NCT01552057|143305335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.91|||<|0.0001|TWO_SIDED|95.0|4.39|11.43||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Mental Health||11.43|4.39|<0.0001
71891795|NCT01552057|143305336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.85||||0.0002|TWO_SIDED|95.0|-4.32|-1.38||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-1.38|-4.32|0.0002
71891796|NCT01552057|143305337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0029|TWO_SIDED|95.0|-2.12|-0.44||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||WPI||-0.44|-2.12|0.0029
71891797|NCT01552057|143305337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0906|TWO_SIDED|95.0|-0.79|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Symptom Severity||0.06|-0.79|0.0906
71891798|NCT01552057|143305338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0755|TWO_SIDED|95.0|-0.7|0.03||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Pain||0.03|-0.70|0.0755
71891799|NCT01552057|143305338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0232|TWO_SIDED|95.0|-0.88|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.06|-0.88|0.0232
71891800|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0126|TWO_SIDED|95.0|-0.99|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain||-0.12|-0.99|0.0126
71669150|NCT02750618|142855214|SUPERIORITY||Least Squares Mean Difference|0.96|||<|0.0001|TWO_SIDED|95.0|0.73|1.19|||GEE model|||||1.19|0.73|< 0.0001
71669151|NCT02750618|142855216|SUPERIORITY||Difference in LS Means|2.21|||<|0.0001|TWO_SIDED|95.0|2.07|2.35|||GEE model|||||2.35|2.07|< 0.0001
71784062|NCT03761277|143066884|NON_INFERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|ONE_SIDED|97.5||-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, i.e., the change in pain intensity is not greater than 0 by more than 10 points from Baseline to the 6-Month Visit.|Due to non-normality, the non-inferiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and the upper 97.5% confidence limit are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1||< 0.001
71784063|NCT03761277|143066884|SUPERIORITY|This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit, with change calculated as 6-Month - Baseline.|Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|25.0|<|0.001|TWO_SIDED|95.0|-22.7|-7.1|||Wilcoxon Signed Rank test|||This analysis was to demonstrate pain intensity scores (VAS) at the 6-Month Visit are less than VAS at Baseline, i.e., the reduction in pain intensity is less than 0 from Baseline to the 6-Month Visit.|Due to non-normality, the superiority test was conducted using a Wilcoxon Signed Rank test, rather than a one-sample t-test. Mean reduction in VAS and 95% confidence interval are presented, but the change from baseline was evaluated using non-parametric analysis methods.|-7.1|-22.7|< 0.001
71784064|NCT05426902|143066901|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
71784065|NCT05426902|143066902|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.6
71784066|NCT05426902|143066903|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline (month 1) vs. intervention period (month 2)||||0.2
71784067|NCT05426902|143066904|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||<0.0001
71669152|NCT02750618|142855217|SUPERIORITY||Difference in LS Means|2.23|||<|0.0001|TWO_SIDED|95.0|2.01|2.45|||GEE model|||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The least squares (LS) mean, standard error (SE), 95% confidence interval (CI) and 2-sided p-value are from the GEE model.||2.45|2.01|< 0.0001
71784068|NCT05426902|143066905|SUPERIORITY|||||||0.4|||||||Fisher Exact|||Baseline (month 1) vs. intervention period (month 2)||||0.4
71784069|NCT05426902|143066910|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"I feel good about my medical visit at baseline (month 1) vs. intervention period (month 2)."||||0.7
71784070|NCT05426902|143066910|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"My rheumatologist gave me his/her full attention at baseline (month 1) vs. intervention period (month 2)."||||0.8
71784071|NCT05426902|143066910|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"I was able to say everything I wanted to say to my rheumatologist at baseline (month 1) vs. intervention period (month 2)."||||1.0
71784072|NCT05426902|143066912|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"My rheumatologist and I agreed on how active my lupus was today at baseline (month 1) vs. intervention period (month 2)."||||0.7
71784073|NCT05426902|143066912|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||"I understand the care recommendations that my doctor or provider gave me today at baseline (month 1) vs. intervention period (month 2)."||||0.8
71784074|NCT05426902|143066913|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline vs. Follow-Up||||0.02
71784075|NCT05426902|143066914|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke meets my approval at baseline (month 1) vs. intervention period (month 2)."||||0.7
71784076|NCT05426902|143066914|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke is appealing to me at baseline (month 1) vs. intervention period (month 2)."||||1.0
71784077|NCT05426902|143066914|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||"I like SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.5
71784078|NCT05426902|143066914|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||"I welcome SLE@Duke at baseline (month 1) vs. intervention period (month 2)."||||0.6
71784079|NCT05426902|143066915|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems fitting at baseline (month 1) vs. intervention period (month 2)."||||0.7
71784080|NCT05426902|143066915|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||"SLE@Duke seems suitable at baseline (month 1) vs. intervention period (month 2)."||||0.7
71784081|NCT05426902|143066915|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems applicable at baseline (month 1) vs. intervention period (month 2)."||||1.0
71669153|NCT02750618|142855218|SUPERIORITY||Difference in LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.53|||GEE model|||||-1.53|-1.98|< 0.0001
71669154|NCT02750618|142855219|SUPERIORITY||Difference in LS Means|-2.02|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.8||The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|GEE model|||||-1.80|-2.25|< 0.0001
71784082|NCT05426902|143066915|SUPERIORITY|||||||1|||||||t-test, 2 sided|||"SLE@Duke seems like a good match at baseline (month 1) vs. intervention period (month 2)."||||1.0
71784083|NCT05426902|143066916|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems implementable at baseline (month 1) vs. intervention period (month 2)."||||0.3
71784084|NCT05426902|143066916|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems possible at baseline (month 1) vs. intervention period (month 2)."||||0.3
71784085|NCT05426902|143066916|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||"SLE@Duke seems doable at baseline (month 1) vs. intervention period (month 2)."||||0.4
71784086|NCT05426902|143066916|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||"SLE@Duke seems easy to use at baseline (month 1) vs. intervention period (month 2)."||||0.3
71784087|NCT01751867|143066987|SUPERIORITY_OR_OTHER||ORR %|29.4||||0.003|TWO_SIDED|95.0|15.1|47.5|||Exact binomial proportion test||ORR % = Number of participants who achieved response divided by total ITT participants|Null Hypothesis: threshold for statistical significance = 10%||47.5|15.1|0.003
71784088|NCT01751867|143066987|SUPERIORITY_OR_OTHER||ORR %|25.5|||<|0.001|TWO_SIDED|95.0|17.2|35.3|||Exact binomial proportion test|||Null Hypothesis: threshold for statistical significance = 10%||35.3|17.2|<0.001
71784089|NCT01806545|143066994|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.11||||0.1197|TWO_SIDED|95.0|-0.242|0.025||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.025|-0.242|0.1197
71784090|NCT01806545|143066995|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.08||||0.1962|TWO_SIDED|95.0|-0.204|0.045||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel|||||0.045|-0.204|0.1962
71784091|NCT01806545|143066996|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||||||0.090
71784092|NCT01806545|143066997|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Log Rank|P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.||Analysis of time to loss of patency||||0.193
71784093|NCT01806545|143066998|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.231
71784094|NCT01806545|143066999|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|TWO_SIDED|||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.158
71784095|NCT01806545|143067000|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.895|||||TWO_SIDED|95.0|-2.213|0.423||||||Treatment difference at week 12||0.423|-2.213|
71784096|NCT01806545|143067000|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|-0.232|||||TWO_SIDED|95.0|-1.791|1.327||||||Treatment difference at week 26||1.327|-1.791|
71784097|NCT01806545|143067001|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|-0.04|||||TWO_SIDED|95.0|-0.273|0.2||||||Analysis of week 12||0.200|-0.273|
71784098|NCT01806545|143067001|SUPERIORITY_OR_OTHER_LEGACY||Proportion treatment difference|0.08|||||TWO_SIDED|95.0|-0.165|0.318||||||Analysis of week 26||0.318|-0.165|
71784099|NCT01806545|143067002|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.154|||||TWO_SIDED|95.0|-0.096|0.404||||||Analysis of week 12||0.404|-0.096|
71784100|NCT01806545|143067002|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.565|||||TWO_SIDED|95.0|-0.023|1.152||||||Analysis of week 26||1.152|-0.023|
71784101|NCT02064894|143067005|SUPERIORITY_OR_OTHER|||||||0.81|||||||Cochran-Mantel-Haenszel|||||||0.81
71784102|NCT02864498|143067108|SUPERIORITY|||||||0.557|||||||General Linear Model|||||||0.5570
71784103|NCT02864498|143067108|SUPERIORITY|||||||0.8774|||||||General Linear Model|||||||0.8774
71784104|NCT04950998|143067115|SUPERIORITY||Mean Difference (Final Values)|604.07|STANDARD_DEVIATION|2560.36||0.376|TWO_SIDED|95.0|-813.815|2021.95|||t-test, 2 sided|||||2021.95|-813.815|0.376
71784105|NCT04950998|143067116|SUPERIORITY||Mean Difference (Final Values)|-35.019|STANDARD_DEVIATION|172.168||0.444|TWO_SIDED|95.0|-130.36|60.324|||t-test, 2 sided|||||60.324|-130.36|.444
71784106|NCT02557555|143067160|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Researched options for labor pain|Test of equal proportion (50/50)|||||||<0.0001
71784107|NCT02557555|143067160|OTHER|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Pamphlet better explained options for pain|Test of equal proportion (50/50)|||||||<0.0001
71784108|NCT02557555|143067160|OTHER||||||<|0.0001||||||Pamphlet should be given before onset labor pain|Test of equal proportion (50/50)|||||||<0.0001
71784109|NCT02557555|143067160|OTHER||||||<|0.0001||||||Pamphlet information helped to reduce anxiety|Test of equal proportion (50/50)|||||||<0.0001
71784110|NCT02557555|143067160|OTHER|||||||0.0002||||||Information corrected any misconception|Test of equal proportion (50/50)|||||||0.0002
71784111|NCT02557555|143067160|OTHER||||||<|0.0001||||||Written information should always be available|Test of equal proportion (50/50)|||||||<0.0001
71836229|NCT03978871|143178189|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.002|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.002
71784112|NCT01362205|143067183|OTHER|||||||0.2454|||||||Wilcoxon (Mann-Whitney)|||||||0.2454
71784113|NCT01372462|143067199|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||The primary endpoint was difference in endurance between nasal cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD, and α=0.05, a sample size of 15 yielded 85% power.||||<0.05
71784114|NCT01372462|143067199|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71784115|NCT01372462|143067199|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71784116|NCT01372462|143067200|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons test||||< 0.05
71784117|NCT01372462|143067200|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71784118|NCT01372462|143067200|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71784119|NCT01372462|143067201|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons tests|ANOVA|Newman-Keuls multiple comparisons tests||Per protocol||||<0.05
71784120|NCT01372462|143067201|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71784121|NCT01372462|143067201|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71784122|NCT01269463|143067205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
71784123|NCT01269463|143067206|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
71784124|NCT04404361|143067216|SUPERIORITY||Risk Difference (RD)|1.51||||0.8516|TWO_SIDED|95.0|-10.55|13.53|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5).||||13.53|-10.55|0.8516
71784125|NCT04404361|143067217|SUPERIORITY|||||||0.7494|||||||Wilcoxon (Mann-Whitney)|||||||0.7494
71784126|NCT04404361|143067218|SUPERIORITY||Odds Ratio (OR)|1.29||||0.6323|TWO_SIDED|95.0|0.46|3.58|||Cochran-Mantel-Haenszel||OR from a CMH test stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||3.58|0.46|0.6323
71784127|NCT04404361|143067219|SUPERIORITY||Odds Ratio (OR)|1.25||||0.7541|TWO_SIDED|95.0|0.31|4.96|||Cochran-Mantel-Haenszel||OR from a CMH test Stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS|||4.96|0.31|0.7541
71784128|NCT04404361|143067220|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.5666|TWO_SIDED|95.0|0.79|1.53||"log-rank test stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5) as entered in the IXRS"|Log Rank|"stratified by randomization stratification factors age (\<60 years versus~≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)"|estimated using a stratified Cox proportional hazards model stratified by randomization stratification factors age (\<60 years versus ≥60 years) and 7-point clinical status scale (baseline 3 or 4 versus 5)|||1.53|0.79|0.5666
71784129|NCT04404361|143067222|SUPERIORITY||Odds Ratio (OR)|2.46||||0.2722|TWO_SIDED|95.0|0.47|12.93|||Chi-squared|||||12.93|0.47|0.2722
71784130|NCT01125605|143067228|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed||||0.0033
71784131|NCT01125605|143067228|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit1) and last observation by duration of treatment||||0.0002
71784132|NCT01125605|143067229|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||||||0.0014
71784133|NCT01125605|143067230|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Fisher Exact|||||||0.0125
71784134|NCT01125605|143067231|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Fisher Exact|||||||0.0006
71784135|NCT01125605|143067232|SUPERIORITY_OR_OTHER|||||||0.0016||95.0|||||Fisher Exact|||||||0.0016
71669155|NCT02750618|142855220|SUPERIORITY||Difference in LS Means|1.21|||<|0.0001|TWO_SIDED|95.0|0.9|1.51|||GEE model|||||1.51|0.90|< 0.0001
71784136|NCT01125605|143067233|SUPERIORITY_OR_OTHER|||||||0.0504||95.0|||||Fisher Exact|||||||0.0504
71784137|NCT01125605|143067235|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||||||0.0002
71784138|NCT05405309|143067307|OTHER||||||||||||||||||"The primary analysis was of safety and included all patients who received at least one dose of the investigational regimen. The rate of adverse events was estimated after the first 5 patients were treated at Original DL1 (camonsertib 40mg daily and olaparib 100mg BID dosing 2 days per week, at 28 day cycles)~After the first 5 patients were treated, it was determined that this dosing strategy may not be appropriate for R/R CLL patients and reduced dosing frequency may be necessary to increase the safety of the combination therapy. The protocol and DLs were amended, and sought to enroll an additional 18 patients.~Before the enrollment of 18 additional participants and MTD determination, the study was terminated due to sponsor de-activation of all programs associated with camonsertib."|||
71784139|NCT00540514|143067333|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.313||||0.005|TWO_SIDED|95.1|1.082|1.593||Statistical significance defined as P-value \< 0.049.|Chi-squared||Response rate ratio = PA/PT. A response rate ratio \> 1 favors the albumin-bound paclitaxel/carboplatin arm of the study.|The null hypothesis is that the albumin-bound paclitaxel/carboplatin regimen response rate (PA) is equal to that of the paclitaxel (Taxol)/carboplatin regimen (PT). Superiority of albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin will be established if the lower bound of the 95.1% CI of the response rate ratio is \> 1.0.||1.593|1.082|0.005
71784140|NCT00540514|143067334|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.902||||0.214|TWO_SIDED|95.1|0.767|1.06||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.060|0.767|0.214
71784141|NCT00540514|143067335|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.922||||0.271|TWO_SIDED|95.1|0.797|1.066||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.066|0.797|0.271
71784142|NCT00540514|143067336|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.074||||0.239|TWO_SIDED|95.0|0.953|1.21|||Chi-squared|||||1.210|0.953|0.239
71784143|NCT00540514|143067337|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.901||||0.551|TWO_SIDED|95.0|0.652|1.244||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma or Non squamous cell carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) \<1 favors the albumin-bound paclitaxel/carboplatin group.|||1.244|0.652|0.551
71784144|NCT00540514|143067340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.302||95.0|||||Univariate Cox regression|||SPARC correlation with overall survival for the overall SPARC population.||||0.302
71784145|NCT00540514|143067341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036||95.0||||A nonsignificant interaction P-value (ie, p-value ≥ 0.100) indicates the treatment regimen effect was consistent within a prognostic factor.|Regression, Logistic|Logistic regression model with effects for treatment regimen, prognostic factor (histology), and treatment regimen by prognostic factor interaction.||||||0.036
71836230|NCT03978871|143178190|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.227|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.227
71836231|NCT03978871|143178191|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.272|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect for accuracy (Growth Mindset vs. Brain Education). This is a test of between-subjects effect.||||0.272
71836232|NCT03978871|143178192|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.217|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.217
71752487|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|||<|0.0001|TWO_SIDED|95.0|0.73|1.71|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.710|0.730|<.0001
71752488|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.221|||<|0.0001|TWO_SIDED|95.0|0.727|1.716|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.716|0.727|<.0001
71784146|NCT02674529|143067367|OTHER|This was a mechanistic trial and non-inferiority or equivalence analysis were not performed.|regression coefficient|-1.29864|STANDARD_ERROR_OF_MEAN|2.3||0.58|TWO_SIDED|95.0|||||Regression, Linear|Drug (antidepressant vs. placebo) prediction of changes in mood as measured by the MADRS scores.||||||0.58
71784147|NCT02674529|143067367|OTHER||r|0.02||||0.05|TWO_SIDED||||||Correlation|Change in MADRS after 8 weeks correlation with brain responses during the baseline fMRI task.||||||0.05
71836233|NCT03978871|143178192|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.458|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation involuntary dysregulation subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.458
71836234|NCT03978871|143178192|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.037|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect.||||0.037
71891801|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0092|TWO_SIDED|95.0|-0.87|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Least Pain||-0.12|-0.87|0.0092
71784148|NCT02674529|143067368|OTHER|This is a mechanistic trial, we did not perform non-inferiority or equivalence analysis.|regression coefficient|-1.4328918|STANDARD_DEVIATION|1.4||0.8|TWO_SIDED|95.0|||||Regression, Linear|||||||0.8
71784149|NCT02674529|143067369|OTHER||||||<|0.05||||||The resulting voxel-wise parametric maps are thresholded with height and extent values generated by Monte Carlo simulations with 3dClustSim to protect against overall type I error at p \< 0.05.|t-test, 2 sided|||At the group-level, a random-effects analysis determines the main effects of the regressors of interest (e.g., high vs. low expectancy) resulting in statistical parametric maps (t or F statistics). To control for potential confounders, sex and depression severity will be entered as covariates in statistical models.||||<0.05
71784150|NCT02891850|143067370|EQUIVALENCE|The hypothesis was that there was no difference in the satisfactory clinical response rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|2.78||||0.0007|TWO_SIDED|95.0|1.526|5.06|||Mantel Haenszel|Stratified by PAH category at baseline||||5.060|1.526|0.0007
71784151|NCT02891850|143067371|EQUIVALENCE|The hypothesis was that there was no difference in the change of 6MWD in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|22.56||||0.0542|TWO_SIDED|95.0|5.03|40.1|||t-test, 2 sided|Stratified by PAH category at baseline||||40.10|5.03|0.0542
71784152|NCT02891850|143067372|EQUIVALENCE|The hypothesis was that there was no difference in the change of NT-proBNP in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-169.65||||0.1067|TWO_SIDED|95.0|-426.18|86.88|||t-test, 2 sided|Stratified by PAH category at baseline||||86.88|-426.18|0.1067
71784153|NCT02891850|143067373|EQUIVALENCE|The hypothesis was that there was no difference in the change from baseline in WHO FC in terms of mean difference when treated with riociguat compared with participants who remained on their previous therapy.|Mean Difference (Final Values)|-0.26||||0.0007|TWO_SIDED|95.0|-0.42|-0.11|||t-test, 2 sided|Stratified by PAH category at baseline||||-0.11|-0.42|0.0007
71784154|NCT02891850|143067374|EQUIVALENCE|The hypothesis was that there was no difference in the clinical worsening rates in terms of odds ratio (OR) when treated with riociguat compared with participants who remained on their previous therapy.|Odds Ratio (OR)|0.1||||0.0047|TWO_SIDED|95.0|0.013|0.725|||Mantel Haenszel|Stratified by PAH category at baseline||||0.725|0.013|0.0047
71677114|NCT03963232|142872627|SUPERIORITY||Odds Ratio (OR)|3.309|||<|0.0001|TWO_SIDED|95.0|1.989|5.504|||GLIMMIX|||100% responder||5.504|1.989|<.0001
71784155|NCT02548650|143067388|NON_INFERIORITY|Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.|Mean Difference (Net)|12.0|||>|0.05|TWO_SIDED|95.0|3.0|21.0|||ANOVA|||The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment||21|3|>0.05
71784156|NCT01539538|143067390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of - 15% for lower boundary of 95% confidence interval|difference in proportion|12.9|||<|0.001|TWO_SIDED|95.0|3.69|22.11|||one-sided, z-test|||||22.11|3.69|<0.001
71784157|NCT01539538|143067390|SUPERIORITY_OR_OTHER||Difference in proportion|12.9||||0.007|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.007
71784158|NCT00378378|143067392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from basline||||0.258
71784159|NCT00378378|143067392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.735
71784160|NCT00378378|143067392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.194||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.||||0.194
71677115|NCT03963232|142872628|SUPERIORITY||LS Mean Difference|7.07|STANDARD_DEVIATION|0.95|<|0.0001|TWO_SIDED|95.0|5.2|8.95|||Mixed Models Analysis|||||8.95|5.20|<.0001
71784161|NCT00378378|143067393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint||||0.361
71669156|NCT02750618|142855221|SUPERIORITY||Difference in LS Means|1.51|||<|0.0001|TWO_SIDED|95.0|1.27|1.76||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|GEE|||||1.76|1.27|< 0.0001
71669157|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-82.91||||0.0004|TWO_SIDED|95.0|-128.68|-37.15|||GEE model|||Week 4||-37.15|-128.68|0.0004
71669158|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-83.84||||0.064|TWO_SIDED|95.0|-172.55|4.88|||GEE model|||Week 12||4.88|-172.55|0.0640
71669159|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-161.38|||<|0.0001|TWO_SIDED|95.0|-186.7|-136.05|||GEE model|||Week 20||-136.05|-186.70|< 0.0001
71669160|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-214.99|||<|0.0001|TWO_SIDED|95.0|-241.7|-188.28|||GEE model|||Week 40||-188.28|-241.70|< 0.0001
71669161|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-226.58|||<|0.0001|TWO_SIDED|95.0|-249.11|-204.06|||GEE model|||Week 48||-204.06|-249.11|< 0.0001
71669162|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-216.45|||<|0.0001|TWO_SIDED|95.0|-248.13|-184.77|||GEE model|||Week 56||-184.77|-248.13|< 0.0001
71669163|NCT02750618|142855225|SUPERIORITY||Difference in LS Means|-216.76|||<|0.0001|TWO_SIDED|95.0|-241.66|-191.86|||GEE model|||Week 64||-191.86|-241.66|< 0.0001
71669164|NCT02750618|142855225|SUPERIORITY||LS Mean|-231.22|||<|0.0001|TWO_SIDED|95.0|-262.51|-199.93|||GEE|||Week 76||-199.93|-262.51|< 0.0001
71669165|NCT02750618|142855225|SUPERIORITY||LS Mean|-237.78|||<|0.0001|TWO_SIDED|95.0|-262.94|-212.62|||GEE|||Week 88||-212.62|-262.94|< 0.0001
71669166|NCT02750618|142855225|SUPERIORITY||LS Mean|-218.14|||<|0.0001|TWO_SIDED|95.0|-248.21|-188.08|||GEE|||Week 100||-188.08|-248.21|< 0.0001
71669167|NCT02750618|142855225|SUPERIORITY||LS Mean|-233.91|||<|0.0001|TWO_SIDED|95.0|-255.66|-212.16|||GEE|||Week 112||-212.16|-255.66|< 0.0001
71669168|NCT02750618|142855225|SUPERIORITY||LS Mean|-252.22|||<|0.0001|TWO_SIDED|95.0|-268.51|-235.93|||GEE|||Week 124||-235.93|-268.51|< 0.0001
71669169|NCT02750618|142855225|SUPERIORITY||LS Mean|-267.89|||<|0.0001|TWO_SIDED|95.0|-293.61|-242.16|||GEE|||Week 136||-242.16|-293.61|< 0.0001
71669170|NCT02750618|142855225|SUPERIORITY||LS Mean|-248.05|||<|0.0001|TWO_SIDED|95.0|-272.85|-223.25|||GEE|||Week 148||-223.25|-272.85|< 0.0001
71669171|NCT02750618|142855225|SUPERIORITY||LS Mean|-248.47|||<|0.0001|TWO_SIDED|95.0|-270.01|-226.93|||GEE|||Week 160||-226.93|-270.01|< 0.0001
71669172|NCT01038336|142855227|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|||||||0.289
71669173|NCT01038336|142855228|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
71669174|NCT01038336|142855229|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||ANOVA|||||||0.072
71669175|NCT01038336|142855230|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||||||0.030
71669176|NCT01038336|142855231|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||ANOVA|||||||0.092
71669177|NCT01038336|142855232|SUPERIORITY_OR_OTHER|||||||0.832|TWO_SIDED||||||ANOVA|||||||0.832
71669178|NCT01038336|142855233|SUPERIORITY_OR_OTHER|||||||0.454|TWO_SIDED||||||ANOVA|||||||0.454
71669179|NCT01038336|142855234|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||ANOVA|||||||0.128
71784162|NCT00378378|143067393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.603
71784163|NCT00378378|143067393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193||95.0|||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.||||0.193
71784164|NCT00407797|143067394|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
71784165|NCT00407797|143067395|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<.0001
71784166|NCT00407797|143067396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
71784167|NCT00407797|143067397|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \<= 6 seizures during Baseline period.||||<.0001
71669180|NCT02763046|142855244|SUPERIORITY||Odds Ratio (OR)|1.32||||0.3512|TWO_SIDED|95.0|0.74|2.36|||Regression, Logistic|||||2.36|0.74|0.3512
71669181|NCT02763046|142855245|SUPERIORITY||Odds Ratio (OR)|1.33||||0.401|TWO_SIDED|95.0|0.68|2.6|||Regression, Logistic|||Week 12||2.60|0.68|0.4010
71669182|NCT02763046|142855245|SUPERIORITY||Odds Ratio (OR)|1.3||||0.4382|TWO_SIDED|95.0|0.67|2.55|||Regression, Logistic|||Week 12||2.55|0.67|0.4382
71669183|NCT02763046|142855245|SUPERIORITY||Odds Ratio (OR)|1.78||||0.0934|TWO_SIDED|95.0|0.91|3.5|||Regression, Logistic|||Week 16||3.50|0.91|0.0934
71669184|NCT02763046|142855245|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2619|TWO_SIDED|95.0|0.75|2.9|||Regression, Logistic|||Week 16||2.90|0.75|0.2619
71669185|NCT02763046|142855246|SUPERIORITY||LS (least square) Mean|-10.29|STANDARD_ERROR_OF_MEAN|6.25||0.0997|TWO_SIDED|95.0|-22.55|1.96|||Mixed Model for Repeated Measures (MMRM)|||||1.96|-22.55|0.0997
71669186|NCT02763046|142855246|SUPERIORITY||LS Mean|-12.3|STANDARD_ERROR_OF_MEAN|7.23||0.0888|TWO_SIDED|95.0|-26.47|1.87|||Mixed Model for Repeated Measures (MMRM)|||||1.87|-26.47|0.0888
71669187|NCT02763046|142855246|SUPERIORITY||LS Mean|-8.29|STANDARD_ERROR_OF_MEAN|7.18||0.2484|TWO_SIDED|95.0|-22.36|5.79|||Mixed Model for Repeated Measures (MMRM)|||||5.79|-22.36|0.2484
71669188|NCT02763046|142855247|SUPERIORITY||LS Mean|-2.06||||0.7735|TWO_SIDED|95.0|-16.11|11.98|||Mixed Model for Repeated Measures (MMRM)|||delayed tapering (W12) vs early tapering (W16)||11.98|-16.11|0.7735
71669189|NCT02763046|142855248|SUPERIORITY||LS Mean|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1926|TWO_SIDED|95.0|-0.99|0.2|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.20|-0.99|0.1926
71669190|NCT02763046|142855248|SUPERIORITY||LS Mean|-0.46|STANDARD_ERROR_OF_MEAN|0.35||0.1914|TWO_SIDED|95.0|-1.14|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.23|-1.14|0.1914
71669191|NCT02763046|142855248|SUPERIORITY||LS Mean|-0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3397|TWO_SIDED|95.0|-1.01|0.35|||Mixed Model for Repeated Measures (MMRM)|||Week 12||0.35|-1.01|0.3397
71669192|NCT02763046|142855248|SUPERIORITY||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.0384|TWO_SIDED|95.0|-1.33|-0.04|||Mixed Model for Repeated Measures (MMRM)|||Week 16||-0.04|-1.33|0.0384
71784168|NCT00407797|143067397|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Participants with \> 6 seizures during Baseline Period.||||<.0001
71752489|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.224|||<|0.0001|TWO_SIDED|95.0|0.716|1.732|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.732|0.716|<.0001
71784169|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0552
71784170|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0350
71784171|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||t-test, 2 sided|||Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.6743
71752490|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.225|||<|0.0001|TWO_SIDED|95.0|0.707|1.744|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.744|0.707|<.0001
71752491|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.228|||<|0.0001|TWO_SIDED|95.0|0.687|1.769|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.769|0.687|<.0001
71752492|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.229|||<|0.0001|TWO_SIDED|95.0|0.673|1.785|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.785|0.673|<.0001
71784172|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4736|TWO_SIDED||||||t-test, 2 sided|||LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.4736
71784173|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8173|TWO_SIDED||||||t-test, 2 sided|||Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8173
71784174|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9092|TWO_SIDED||||||t-test, 2 sided|||LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.9092
71784175|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1091|TWO_SIDED||||||t-test, 2 sided|||Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1091
71784176|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||t-test, 2 sided|||LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0944
71784177|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928|TWO_SIDED||||||t-test, 2 sided|||Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.8928
71784178|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7669|TWO_SIDED||||||t-test, 2 sided|||LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.7669
71784179|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1698|TWO_SIDED||||||t-test, 2 sided|||Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1698
71784180|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0898|TWO_SIDED||||||t-test, 2 sided|||LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0898
71784181|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0465|TWO_SIDED||||||t-test, 2 sided|||Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0465
71784182|NCT00407797|143067403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0316|TWO_SIDED||||||t-test, 2 sided|||LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0316
71784183|NCT00407797|143067404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2187|TWO_SIDED|95.0|||||t-test, 2 sided|||Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.2187
71784184|NCT00407797|143067404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1905|TWO_SIDED|95.0|||||t-test, 2 sided|||LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.1905
71784185|NCT00407797|143067405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
71784186|NCT00407797|143067405|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||<.0001
71784187|NCT00407797|143067405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0799|TWO_SIDED||||||t-test, 2 sided|||Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0799
71784188|NCT00407797|143067405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846|TWO_SIDED||||||t-test, 2 sided|||Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.||||0.0846
71813110|NCT03720938|143128561|SUPERIORITY||||||‬|2.82e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.||||0.0000282‬
71669193|NCT02763046|142855248|SUPERIORITY||LS Mean|-0.41|STANDARD_ERROR_OF_MEAN|0.33||0.2116|TWO_SIDED|95.0|-1.05|0.23|||Mixed Model for Repeated Measures (MMRM)|||Week 16||0.23|-1.05|0.2116
71669194|NCT02763046|142855249|SUPERIORITY||LS Mean|0.63|STANDARD_ERROR_OF_MEAN|1.02||0.5384|TWO_SIDED|95.0|-1.38|2.63|||Mixed Model for Repeated Measures (MMRM)|||||2.63|-1.38|0.5384
71669195|NCT02763046|142855249|SUPERIORITY||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|1.18||0.9251|TWO_SIDED|95.0|-2.43|2.21|||Mixed Model for Repeated Measures (MMRM)|||||2.21|-2.43|0.9251
71669196|NCT02763046|142855249|SUPERIORITY||LS Mean|1.36|STANDARD_ERROR_OF_MEAN|1.16||0.2432|TWO_SIDED|95.0|-0.93|3.66|||Mixed Model for Repeated Measures (MMRM)|||||3.66|-0.93|0.2432
71784189|NCT01537393|143067425|NON_INFERIORITY|The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.|Risk Difference (RD)|3.2|||||ONE_SIDED|95.0||5.4|||||||The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.|5.4||
71784190|NCT01537393|143067425|OTHER|Confounding and treatment interactions were assessed in Cox proportional hazards regression models|Hazard Ratio (HR)|1.71||||0.02|TWO_SIDED|95.0|1.09|2.71|||Regression, Cox|Unadjusted Hazard Ratio||||2.71|1.09|0.02
71784191|NCT01537393|143067426|OTHER|The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.|Mean Difference (Final Values)|73.0||||0.03|TWO_SIDED|95.0|8.0|138.0|||Mixed Models Analysis|Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor||||138|8|0.03
71784192|NCT04518293|143067427|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a mixed model for repeated measures (MMRM).|LS Means Difference|-5.44|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-6.774|-4.107|||MIANALYZE procedure|||The LS means (LSM) difference (95% CI) in home seated SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.107|-6.774|<.0001
71784193|NCT04518293|143067427|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.723|-1.251|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.251|-3.723|<.0001
71669197|NCT03052751|142855271|SUPERIORITY||LS Mean Difference vs Placebo|-0.7|||=|0.221|ONE_SIDED|95.0||0.8||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"Mixed Model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline QMG score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.8||=0.221
71784194|NCT04518293|143067427|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.42|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.758|-3.091|||MIANALYZE procedure|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.091|-5.758|<.0001
71784195|NCT04518293|143067428|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using a MMRM.|LS Means Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.863|<|0.0001|TWO_SIDED|95.0|-7.307|-3.902|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 between dual-TA arms.||-3.902|-7.307|<.0001
71784196|NCT04518293|143067428|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using a MMRM.|LS Means Difference|-4.33|STANDARD_ERROR_OF_MEAN|1.212||0.0005|TWO_SIDED|95.0|-6.718|-1.933|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.933|-6.718|0.0005
71784197|NCT04518293|143067428|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using a MMRM.|LS Means Difference|-6.33|STANDARD_ERROR_OF_MEAN|0.837|<|0.0001|TWO_SIDED|95.0|-7.984|-4.68|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-4.680|-7.984|<.0001
71784198|NCT04518293|143067429|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-5.01|STANDARD_ERROR_OF_MEAN|0.858|<|0.0001|TWO_SIDED|95.0|-6.703|-3.317|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TA arms.||-3.317|-6.703|<.0001
71784199|NCT04518293|143067429|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.91||0.0002|TWO_SIDED|95.0|-5.293|-1.7|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.700|-5.293|0.0002
71836235|NCT03978871|143178192|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.107|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation proactive engagement subscale post psycho-educational lesson. This is a test of between-subjects effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.107
71669198|NCT03052751|142855272|SUPERIORITY||LS Mean Difference vs Placebo|-1.8|||=|0.089|ONE_SIDED|95.0||0.4||One-sided p-value was presented for difference.|MMRM||Estimate included treatment and treatment by visit interaction effects.|"MMRM ANCOVA model included fixed terms for treatment group, visit, interaction between treatment group and visit, covariate of Baseline MG-composite score, and random effect for participant.~The differences presented was 'UCB7665 (7 mg/kg) minus Placebo'."||0.4||=0.089
71669199|NCT03052751|142855273|SUPERIORITY||LS Mean Difference vs Placebo|-1.4|||=|0.036|ONE_SIDED|95.0||-0.1||One-sided p-value was presented for difference.|ANCOVA||Estimate included treatment effect.|ANCOVA model included fixed terms for treatment group, covariate of Baseline MGADL score.||-0.1||=0.036
71836236|NCT03978871|143178192|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.369|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) for the ERS emotion regulation cognitive avoidance subscale post psycho-educational lesson. This is a test of between-subjects test.||||0.369
71752493|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.232|||<|0.0001|TWO_SIDED|95.0|0.646|1.818|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.818|0.646|<.0001
71752494|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.233|||<|0.0001|TWO_SIDED|95.0|0.629|1.838|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.838|0.629|<.0001
71752495|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.236||||0.0002|TWO_SIDED|95.0|0.595|1.876|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.876|0.595|0.0002
71784200|NCT04518293|143067429|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.35|STANDARD_ERROR_OF_MEAN|0.965|<|0.0001|TWO_SIDED|95.0|-7.251|-3.444|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.444|-7.251|<.0001
71891802|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0083|TWO_SIDED|95.0|-1.0|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Pain Right Now||-0.15|-1.00|0.0083
71784201|NCT04518293|143067430|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.72|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-4.692|-2.757|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.757|-4.692|<.0001
71784202|NCT04518293|143067430|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-3.51|STANDARD_ERROR_OF_MEAN|0.702|<|0.0001|TWO_SIDED|95.0|-4.897|-2.128|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-2.128|-4.897|<.0001
71784203|NCT04518293|143067430|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.665|<|0.0001|TWO_SIDED|95.0|-5.812|-3.189|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-3.189|-5.812|<.0001
71784204|NCT04518293|143067431|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.487|<|0.0001|TWO_SIDED|95.0|-3.392|-1.469|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TA arms.||-1.469|-3.392|<.0001
71784205|NCT04518293|143067431|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.29|STANDARD_ERROR_OF_MEAN|0.55|<|0.0001|TWO_SIDED|95.0|-3.371|-1.201|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.201|-3.371|<.0001
71784206|NCT04518293|143067431|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.562|<|0.0001|TWO_SIDED|95.0|-4.882|-2.664|||Mixed Models Analysis|||The LSM difference (95% CI) in clinic DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.664|-4.882|<.0001
71784207|NCT04518293|143067432|OTHER||Risk Difference (RD)|12.52||||0.0003|TWO_SIDED|95.0|5.63|19.487|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||19.487|5.630|0.0003
71784208|NCT04518293|143067432|OTHER||Risk Difference (RD)|13.36||||0.0001|TWO_SIDED|95.0|6.392|20.394|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||20.394|6.392|0.0001
71784209|NCT04518293|143067432|OTHER||Risk Difference (RD)|20.97|||<|0.0001|TWO_SIDED|95.0|13.812|28.013|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||28.013|13.812|<.0001
71784210|NCT04518293|143067433|OTHER||Risk Difference (RD)|10.31||||0.0044|TWO_SIDED|95.0|3.044|17.535|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||17.535|3.044|0.0044
71752496|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.237||||0.0003|TWO_SIDED|95.0|0.575|1.899|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.899|0.575|0.0003
71784211|NCT04518293|143067433|OTHER||Risk Difference (RD)|8.08||||0.0262|TWO_SIDED|95.0|0.804|15.373|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.373|0.804|0.0262
71784212|NCT04518293|143067433|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.201|25.746|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||25.746|11.201|<.0001
71784213|NCT04518293|143067434|OTHER||Risk Difference (RD)|16.51|||<|0.0001|TWO_SIDED|95.0|9.707|22.837|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||22.837|9.707|<.0001
71784214|NCT04518293|143067434|OTHER||Risk Difference (RD)|12.03||||0.0004|TWO_SIDED|95.0|4.982|18.658|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||18.658|4.982|0.0004
71784215|NCT04518293|143067434|OTHER||Risk Difference (RD)|18.19|||<|0.0001|TWO_SIDED|95.0|11.412|24.432|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||24.432|11.412|<.0001
71784216|NCT04518293|143067435|OTHER||Risk Difference (RD)|10.45||||0.0007|TWO_SIDED|95.0|3.993|16.433|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||16.433|3.993|0.0007
71784217|NCT04518293|143067435|OTHER||Risk Difference (RD)|8.93||||0.0046|TWO_SIDED|95.0|2.337|15.058|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||15.058|2.337|0.0046
71784218|NCT04518293|143067435|OTHER||Risk Difference (RD)|12.19|||<|0.0001|TWO_SIDED|95.0|5.792|18.073|||Wald test|||||18.073|5.792|<.0001
71669200|NCT01634048|142855288|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71891803|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0807|TWO_SIDED|95.0|-0.98|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With General Activity||0.06|-0.98|0.0807
71891804|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0057|TWO_SIDED|95.0|-1.29|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Mood||-0.22|-1.29|0.0057
71784219|NCT04518293|143067436|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.11|STANDARD_ERROR_OF_MEAN|0.495|<|0.0001|TWO_SIDED|95.0|-7.086|-5.144|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.144|-7.086|<.0001
71784220|NCT04518293|143067436|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.543|<|0.0001|TWO_SIDED|95.0|-4.06|-1.932|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.932|-4.060|<.0001
71784221|NCT04518293|143067436|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-5.09|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-6.274|-3.912|||Mixed Models Analysis|||The LSM difference (95% CI) in home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.912|-6.274|<.0001
71784222|NCT04518293|143067437|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.364|<|0.0001|TWO_SIDED|95.0|-4.069|-2.632|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.632|-4.069|<.0001
71784223|NCT04518293|143067437|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.456|<|0.0001|TWO_SIDED|95.0|-2.998|-1.2|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.200|-2.998|<.0001
71784224|NCT04518293|143067437|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.63|STANDARD_ERROR_OF_MEAN|0.499|<|0.0001|TWO_SIDED|95.0|-4.617|-2.649|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.649|-4.617|<.0001
71784225|NCT04518293|143067438|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-3.52|STANDARD_ERROR_OF_MEAN|0.311|<|0.0001|TWO_SIDED|95.0|-4.137|-2.908|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TA arms.||-2.908|-4.137|<.0001
71784226|NCT04518293|143067438|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.361|<|0.0001|TWO_SIDED|95.0|-2.803|-1.376|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-TI arms.||-1.376|-2.803|<.0001
71784227|NCT04518293|143067438|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-3.58|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-4.446|-2.713|||Mixed Models Analysis|||The LSM difference (95% CI) in home DBP reduction was calculated between GMRx2 and dual-AI arms.||-2.713|-4.446|<.0001
71784228|NCT04518293|143067439|OTHER|The difference between GMRx2 and dual-TA at Week 12 was estimated using MMRM.|LS Means Difference|-5.58|STANDARD_ERROR_OF_MEAN|0.713|<|0.0001|TWO_SIDED|95.0|-6.983|-4.169|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-4.169|-6.983|<.0001
71784229|NCT04518293|143067439|OTHER|The difference between GMRx2 and dual-TI at Week 12 was estimated using MMRM.|LS Means Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.662||0.0043|TWO_SIDED|95.0|-3.218|-0.607|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-0.607|-3.218|0.0043
71784230|NCT04518293|143067439|OTHER|The difference between GMRx2 and dual-AI at Week 12 was estimated using MMRM.|LS Means Difference|-3.74|STANDARD_ERROR_OF_MEAN|0.745|<|0.0001|TWO_SIDED|95.0|-5.214|-2.274|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-2.274|-5.214|<.0001
71784231|NCT04518293|143067440|OTHER|The difference between GMRx2 and dual-TA at Week 6 was estimated using MMRM.|LS Means Difference|-6.25|STANDARD_ERROR_OF_MEAN|0.546|<|0.0001|TWO_SIDED|95.0|-7.324|-5.168|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TA arms.||-5.168|-7.324|<.0001
71784232|NCT04518293|143067440|OTHER|The difference between GMRx2 and dual-TI at Week 6 was estimated using MMRM.|LS Means Difference|-2.72|STANDARD_ERROR_OF_MEAN|0.616|<|0.0001|TWO_SIDED|95.0|-3.941|-1.507|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-TI arms.||-1.507|-3.941|<.0001
71784233|NCT04518293|143067440|OTHER|The difference between GMRx2 and dual-AI at Week 6 was estimated using MMRM.|LS Means Difference|-4.43|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-5.489|-3.368|||Mixed Models Analysis|||The LSM difference (95% CI) in trough (i.e. before morning dose) home SBP reduction was calculated between GMRx2 and dual-AI arms.||-3.368|-5.489|<.0001
71784234|NCT04518293|143067441|OTHER||Risk Difference (RD)|14.79|||<|0.0001|TWO_SIDED|95.0|7.749|21.824|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||21.824|7.749|<.0001
71891805|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.1114|TWO_SIDED|95.0|-0.84|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Walking Ability||0.09|-0.84|0.1114
71891806|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1081|TWO_SIDED|95.0|-0.94|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Normal Work||0.09|-0.94|0.1081
71669201|NCT02719184|142855311|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-2.89|STANDARD_ERROR_OF_MEAN|1.23||0.0202|TWO_SIDED|95.0|-5.32|-0.45|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||-0.45|-5.32|0.0202
71677116|NCT03963232|142872629|SUPERIORITY||LS Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.25|-1.31|||Mixed Models Analysis|||||-1.31|-2.25|<.0001
71752497|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.0005|TWO_SIDED|95.0|0.537|1.942|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.942|0.537|0.0005
71752498|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.241||||0.0008|TWO_SIDED|95.0|0.515|1.967|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||1.967|0.515|0.0008
71752499|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.244||||0.0015|TWO_SIDED|95.0|0.474|2.013|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.013|0.474|0.0015
71752500|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.0021|TWO_SIDED|95.0|0.45|2.04|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.040|0.450|0.0021
71752501|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.248||||0.0037|TWO_SIDED|95.0|0.406|2.089|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.089|0.406|0.0037
71752502|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.249||||0.0048|TWO_SIDED|95.0|0.382|2.116|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.116|0.382|0.0048
71752503|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.251||||0.0074|TWO_SIDED|95.0|0.336|2.167|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.167|0.336|0.0074
71752504|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.253||||0.0092|TWO_SIDED|95.0|0.31|2.196|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.196|0.310|0.0092
71784235|NCT04518293|143067441|OTHER||Risk Difference (RD)|8.46||||0.0146|TWO_SIDED|95.0|1.58|15.501|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||15.501|1.580|0.0146
71752505|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.255||||0.0132|TWO_SIDED|95.0|0.262|2.248|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.248|0.262|0.0132
71752506|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.257||||0.0159|TWO_SIDED|95.0|0.236|2.278|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.278|0.236|0.0159
71784236|NCT04518293|143067441|OTHER||Risk Difference (RD)|16.07|||<|0.0001|TWO_SIDED|95.0|8.953|23.171|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||23.171|8.953|<.0001
71784237|NCT04518293|143067442|OTHER||Risk Difference (RD)|18.11|||<|0.0001|TWO_SIDED|95.0|10.778|25.226|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.226|10.778|<.0001
71784238|NCT04518293|143067442|OTHER||Risk Difference (RD)|6.64||||0.0674|TWO_SIDED|95.0|-0.613|13.926|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||13.926|-0.613|0.0674
71752507|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.259||||0.0213|TWO_SIDED|95.0|0.187|2.332|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.332|0.187|0.0213
71784239|NCT04518293|143067442|OTHER||Risk Difference (RD)|18.23|||<|0.0001|TWO_SIDED|95.0|10.839|25.392|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||25.392|10.839|<.0001
71784240|NCT04518293|143067443|OTHER||Risk Difference (RD)|17.25|||<|0.0001|TWO_SIDED|95.0|9.902|24.286|||Wald test|||The difference between GMRx2 and TA at Week 12 was estimated using Generalized Estimating Equation.||24.286|9.902|<.0001
71784241|NCT04518293|143067443|OTHER||Risk Difference (RD)|12.06||||0.001|TWO_SIDED|95.0|4.632|19.293|||Wald test|||The difference between GMRx2 and TI at Week 12 was estimated using Generalized Estimating Equation.||19.293|4.632|0.0010
71784242|NCT04518293|143067443|OTHER||Risk Difference (RD)|22.93|||<|0.0001|TWO_SIDED|95.0|15.622|29.796|||Wald test|||The difference between GMRx2 and AI at Week 12 was estimated using Generalized Estimating Equation.||29.796|15.622|<.0001
71669202|NCT02719184|142855311|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.78|STANDARD_ERROR_OF_MEAN|1.31||0.0003|TWO_SIDED|95.0|-7.36|-2.19|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.|||-2.19|-7.36|0.0003
71669203|NCT02719184|142855311|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-4.47|STANDARD_ERROR_OF_MEAN|1.51||0.0033|TWO_SIDED|95.0|-7.44|-1.5|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.50|-7.44|0.0033
71669204|NCT02719184|142855311|OTHER|The analysis was based on a Mixed Model for Repeated Measures (MMRM) approach with diagnosis group-by-visit and baseline ALD value-by-visit terms, and unstructured covariance matrix structure for repeated measurements within subject.|Adjusted mean difference|-5.86|STANDARD_ERROR_OF_MEAN|2.74||0.0334|TWO_SIDED|95.0|-11.26|-0.47|||Mixed Model for Repeated Measures (MMRM)||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-0.47|-11.26|0.0334
71752508|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.261||||0.0248|TWO_SIDED|95.0|0.16|2.362|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.362|0.160|0.0248
71752509|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263||||0.0318|TWO_SIDED|95.0|0.11|2.416|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.416|0.110|0.0318
71784243|NCT04518293|143067444|OTHER||Risk Difference (RD)|18.59|||<|0.0001|TWO_SIDED|95.0|11.579|25.124|||Wald test|||The difference between GMRx2 and TA at Week 6 was estimated using Generalized Estimating Equation.||25.124|11.579|<.0001
71784244|NCT04518293|143067444|OTHER||Risk Difference (RD)|12.22||||0.0005|TWO_SIDED|95.0|4.963|19.123|||Wald test|||The difference between GMRx2 and TI at Week 6 was estimated using Generalized Estimating Equation.||19.123|4.963|0.0005
71845405|NCT01478594|143205114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.345|1.507|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.507|0.345|
71669205|NCT02719184|142855312|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|14.4||0.9306|TWO_SIDED|95.0|-27.2|29.7|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD I group - value from Healthy subjects group.|||29.7|-27.2|0.9306
71669206|NCT02719184|142855312|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-19.2|STANDARD_ERROR_OF_MEAN|14.9||0.1983|TWO_SIDED|95.0|-48.5|10.1|||Random slope and intercept model|The mean difference was calculated as value from COPD GOLD II group - value from Healthy subjects group.||||10.1|-48.5|0.1983
71669207|NCT02719184|142855312|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-33.6|STANDARD_ERROR_OF_MEAN|16.1||0.0381|TWO_SIDED|95.0|-65.4|-1.9|||Random slope and intercept model||The mean difference was calculated as value from COPD GOLD III group - value from Healthy subjects group.|||-1.9|-65.4|0.0381
71669208|NCT02719184|142855312|OTHER|A random slope and intercept model with fixed categorical effects of diagnosis group, fixed continuous effects of time, and including diagnosis group-by-time interaction was applied. Random effect was included for subject specific intercept and time. Within-subject errors are modelled by an unstructured variance-covariance matrix.|Unadjusted mean difference|-61.8|STANDARD_ERROR_OF_MEAN|30.3||0.0419|TWO_SIDED|95.0|-121.3|-2.3|||Random slope and intercept model||The mean difference was calculated as value from COPD and A1AT group - value from Healthy subjects group.|||-2.3|-121.3|0.0419
71669209|NCT00725491|142855323|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Whitehead|||||||<0.001
71669210|NCT01495000|142855324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.05|||<|0.0001|TWO_SIDED|95.0|1.91|4.19|||ANCOVA|||||4.19|1.91|<0.0001
71669211|NCT01514461|142855342|SUPERIORITY_OR_OTHER||% change from reference treatment|-28.78||||0.0538|TWO_SIDED|95.0|-55.69|14.46|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||14.46|-55.69|0.0538
71669212|NCT01514461|142855342|SUPERIORITY_OR_OTHER||% change from reference treatment|-40.88||||0.0182|TWO_SIDED|95.0|-63.99|-2.94|||Mixed Models Analysis|Mixed Model of Repeated Measurements||||-2.94|-63.99|0.0182
71669213|NCT03207776|142855391|SUPERIORITY||Odds Ratio (OR)|0.8||||0.041|TWO_SIDED|95.0|0.64|0.99|||Mixed Models Analysis|||||0.99|0.64|0.041
71669214|NCT03207776|142855392|SUPERIORITY||Odds Ratio (OR)|0.99||||0.952|TWO_SIDED|95.0|0.69|1.42|||Mixed Models Analysis|||||1.42|0.69|0.952
71784245|NCT04518293|143067444|OTHER||Risk Difference (RD)|16.2|||<|0.0001|TWO_SIDED|95.0|9.06|22.914|||Wald test|||The difference between GMRx2 and AI at Week 6 was estimated using Generalized Estimating Equation.||22.914|9.060|<.0001
71784246|NCT04518293|143067445|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-1.529|2.768||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TA arms.||2.768|-1.529|
71669215|NCT03207776|142855393|SUPERIORITY||Odds Ratio (OR)|0.91||||0.472|TWO_SIDED|95.0|0.71|1.17|||Mixed Models Analysis|||||1.17|0.71|0.472
71669216|NCT03207776|142855394|SUPERIORITY||Odds Ratio (OR)|1.14||||0.544|TWO_SIDED|95.0|0.74|1.77|||Mixed Models Analysis|||||1.77|0.74|0.544
71669217|NCT00780338|142855395|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.58
71784247|NCT04518293|143067445|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-TI arms.||2.475|-2.098|
71784248|NCT04518293|143067445|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-2.098|2.475||||||The Risk difference (95% CI) in percentage of participants discontinuing trial medication due to AE/SAE at Week 12 was calculated between GMRx2 and dual-AI arms.||2.475|-2.098|
71784249|NCT04518293|143067451|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.07|||||TWO_SIDED|95.0|0.494|7.116||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||7.116|0.494|
71784250|NCT04518293|143067451|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-3.927|4.02||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||4.020|-3.927|
71784251|NCT04518293|143067451|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.64|||||TWO_SIDED|95.0|-0.07|6.764||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||6.764|-0.070|
71784252|NCT04518293|143067452|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.59|||||TWO_SIDED|95.0|-0.5|5.136||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.136|-0.500|
71784253|NCT04518293|143067452|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
71784254|NCT04518293|143067452|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.73|||||TWO_SIDED|95.0|-2.855|3.633||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration below 135 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||3.633|-2.855|
71784255|NCT04518293|143067453|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06|||||TWO_SIDED|95.0|-3.911|3.129||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||3.129|-3.911|
71784256|NCT04518293|143067453|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53|||||TWO_SIDED|95.0|-4.519|2.744||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.744|-4.519|
71784257|NCT04518293|143067453|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-3.228|3.647||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||3.647|-3.228|
71784258|NCT04518293|143067454|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-3.993|2.816||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||2.816|-3.993|
71784259|NCT04518293|143067454|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.82|||||TWO_SIDED|95.0|-1.513|4.517||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.517|-1.513|
71836237|NCT03978871|143178193|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative immerse \> neutral immerse) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.265||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -1.12||||||0.265
71836238|NCT03978871|143178194|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. An ROI mask was generated from left and right amygdala of the AAL1.V4 atlas. First-level contrast estimates (negative \> neutral) for each voxel within the ROI were averaged with MarsBaR to produce a single value for each person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.96||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = -0.53||||||0.96
71784260|NCT04518293|143067454|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.72|||||TWO_SIDED|95.0|-4.596|2.44||||||The Risk difference (95% CI) in percentage of participants with serum sodium concentration above 145 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||2.440|-4.596|
71784261|NCT04518293|143067455|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|6.72|||||TWO_SIDED|95.0|4.196|9.222||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||9.222|4.196|
71752510|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.265||||0.036|TWO_SIDED|95.0|0.083|2.447|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.447|0.083|0.0360
71752511|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.267||||0.0443|TWO_SIDED|95.0|0.032|2.502|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.502|0.032|0.0443
71752512|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.269||||0.0493|TWO_SIDED|95.0|0.004|2.533|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.533|0.004|0.0493
71752513|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.271||||0.0587|TWO_SIDED|95.0|-0.047|2.589|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.589|-0.047|0.0587
71752514|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.273||||0.0642|TWO_SIDED|95.0|-0.075|2.62|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.620|-0.075|0.0642
71752515|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.275||||0.0746|TWO_SIDED|95.0|-0.127|2.677|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.677|-0.127|0.0746
71752516|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.276||||0.0806|TWO_SIDED|95.0|-0.155|2.708|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.708|-0.155|0.0806
71752517|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.279||||0.0917|TWO_SIDED|95.0|-0.207|2.765|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.765|-0.207|0.0917
71752518|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.28||||0.098|TWO_SIDED|95.0|-0.236|2.797|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.797|-0.236|0.0980
71752519|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.283||||0.1095|TWO_SIDED|95.0|-0.288|2.854|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.854|-0.288|0.1095
71752520|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.284||||0.1161|TWO_SIDED|95.0|-0.318|2.886|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.886|-0.318|0.1161
71784262|NCT04518293|143067455|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-1.883|5.257||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||5.257|-1.883|
71784263|NCT04518293|143067455|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-5.97|||||TWO_SIDED|95.0|-10.979|-1.6||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||-1.600|-10.979|
71677117|NCT03963232|142872630|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.35|-1.29|||Mixed Models Analysis|||||-1.29|-2.35|<.0001
71677118|NCT03963232|142872631|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.92|4.81|||Regression, Logistic|||||4.81|1.92|<.0001
71677119|NCT03963232|142872632|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.15|-0.62|||Mixed Models Analysis|||||-0.62|-1.15|<.0001
71784264|NCT04518293|143067456|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.13|||||TWO_SIDED|95.0|0.123|5.632||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||5.632|0.123|
71677120|NCT03963232|142872633|SUPERIORITY||LS Mean Difference|-18.88|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-23.21|-14.56|||Mixed Models Analysis|||||-14.56|-23.21|<.0001
71752521|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.287||||0.128|TWO_SIDED|95.0|-0.37|2.944|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.944|-0.370|0.1280
71752522|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.288||||0.1346|TWO_SIDED|95.0|-0.399|2.976|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||2.976|-0.399|0.1346
71752523|NCT00083889|143008014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.291||||0.1466|TWO_SIDED|95.0|-0.452|3.034|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).||3.034|-0.452|0.1466
71752524|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.929||||0.0001|TWO_SIDED|95.0|0.46|1.398|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).||1.398|0.460|0.0001
71752525|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.922|||<|0.0001||95.0|0.469|1.375|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.375|0.469|<.0001
71752526|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.918|||<|0.0001||95.0|0.471|1.365|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.365|0.471|<.0001
71752527|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.911|||<|0.0001||95.0|0.469|1.352|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.352|0.469|<.0001
71752528|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.907|||<|0.0001||95.0|0.466|1.348|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.348|0.466|<.0001
71752529|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.899|||<|0.0001||95.0|0.453|1.345|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.345|0.453|<.0001
71752530|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.895||||0.0001||95.0|0.444|1.347|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.347|0.444|0.0001
71752531|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.888||||0.0002||95.0|0.421|1.355|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.355|0.421|0.0002
71784265|NCT04518293|143067456|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-2.245|4.134||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||4.134|-2.245|
71784266|NCT04518293|143067456|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.71|||||TWO_SIDED|95.0|-6.968|0.819||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||0.819|-6.968|
71891807|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0264|TWO_SIDED|95.0|-1.04|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Relationships With Other People||-0.07|-1.04|0.0264
71677121|NCT03963232|142872634|SUPERIORITY||LS Mean Difference|-19.24|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-23.73|-14.75|||Mixed Models Analysis|||||-14.75|-23.73|<.0001
71891808|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.3959|TWO_SIDED|95.0|-0.81|0.32||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Sleep||0.32|-0.81|0.3959
71891809|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0119|TWO_SIDED|95.0|-1.18|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Enjoyment of Life||-0.15|-1.18|0.0119
71677122|NCT03963232|142872635|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.22|-0.1|||Mixed Models Analysis|||||-0.10|-0.22|<.0001
71784267|NCT04518293|143067457|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.863|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TA arms.||2.231|-0.863|
71784268|NCT04518293|143067457|OTHER||Risk Difference (RD)|0.91|||||TWO_SIDED|95.0|-0.897|2.231||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-TI arms.||2.231|-0.897|
71784269|NCT04518293|143067457|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.55|||||TWO_SIDED|95.0|-1.494|1.913||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 12 was calculated between GMRx2 and dual-AI arms.||1.913|-1.494|
71784270|NCT04518293|143067458|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.01|||||TWO_SIDED|95.0|-1.931|1.149||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TA arms.||1.149|-1.931|
71784271|NCT04518293|143067458|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.979|1.143||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-TI arms.||1.143|-1.979|
71784272|NCT04518293|143067458|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-1.374|1.453||||||The Risk difference (95% CI) in percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 6 was calculated between GMRx2 and dual-AI arms.||1.453|-1.374|
71677123|NCT03963232|142872636|SUPERIORITY||LS Mean Difference|-0.224|STANDARD_ERROR_OF_MEAN|0.1021||0.0284|TWO_SIDED|95.0|-0.43|-0.02|||ANCOVA|||||-0.02|-0.43|0.0284
71784273|NCT04518293|143067459|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.39|||||TWO_SIDED|95.0|-2.014|2.087||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TA arms.||2.087|-2.014|
71784274|NCT04518293|143067459|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-TI arms.||2.633|-1.015|
71784275|NCT04518293|143067459|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|1.09|||||TWO_SIDED|95.0|-1.015|2.633||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 12 was calculated between GMRx2 and dual-AI arms.||2.633|-1.015|
71784276|NCT04518293|143067460|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-2.501|1.385||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TA arms.||1.385|-2.501|
71784277|NCT04518293|143067460|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.54|||||TWO_SIDED|95.0|-3.078|1.108||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-TI arms.||1.108|-3.078|
71784278|NCT04518293|143067460|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.18|||||TWO_SIDED|95.0|-2.571|1.37||||||The Risk difference (95% CI) in percentage of participants with eGFR drop of over 30% at Week 6 was calculated between GMRx2 and dual-AI arms.||1.370|-2.571|
71784279|NCT04518293|143067461|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|10.55|||||TWO_SIDED|95.0|5.422|15.138||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TA arms.||15.138|5.422|
71784280|NCT04518293|143067461|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|3.11|||||TWO_SIDED|95.0|-2.776|8.49||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-TI arms.||8.490|-2.776|
71784281|NCT04518293|143067461|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.807|4.174||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 12 was calculated between GMRx2 and dual-AI arms.||4.174|-7.807|
71891810|NCT01552057|143305339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0222|TWO_SIDED|95.0|-0.96|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Interference||-0.07|-0.96|0.0222
71891811|NCT01552057|143305340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0113|TWO_SIDED|95.0|-0.71|-0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.09|-0.71|0.0113
71677124|NCT03963232|142872637|SUPERIORITY||LS Mean Difference|-12.429|STANDARD_ERROR_OF_MEAN|3.2484||0.0001|TWO_SIDED|95.0|-18.81|-6.05|||ANCOVA|||||-6.05|-18.81|0.0001
71677125|NCT03467217|142872656|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.95|TWO_SIDED|95.0|-30.6|32.7|||ANCOVA|Adjusted for baseline value of ALT.||||32.7|-30.6|.95
71677126|NCT03467217|142872657|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.56|TWO_SIDED|95.0|-11.0|6.0|||ANCOVA|Adjusted for baseline value of GGT.||||6.0|-11.0|0.56
71784282|NCT04518293|143067462|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|5.47|||||TWO_SIDED|95.0|0.531|9.867||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TA arms.||9.867|0.531|
71891812|NCT01552057|143305341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.0005|TWO_SIDED|95.0|-0.94|-0.27||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.27|-0.94|0.0005
71891813|NCT01552057|143305342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.37||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.37|-1.07|<0.0001
71891814|NCT01552057|143305343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0226|TWO_SIDED|95.0|-0.82|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||||-0.06|-0.82|0.0226
71784283|NCT04518293|143067462|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|4.92|||||TWO_SIDED|95.0|-0.136|9.397||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-TI arms.||9.397|-0.136|
71784284|NCT04518293|143067462|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-7.299|3.567||||||The Risk difference (95% CI) in percentage of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at Week 6 was calculated between GMRx2 and dual-AI arms.||3.567|-7.299|
71784285|NCT04518293|143067463|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.06||||0.9677|TWO_SIDED|95.0|-3.825|3.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.019|-3.825|0.9677
71784286|NCT04518293|143067463|OTHER||Risk Difference (RD)|-2.35||||0.1952|TWO_SIDED|95.0|-6.55|1.125|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-TI arms.||1.125|-6.550|0.1952
71784287|NCT04518293|143067463|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.53||||0.7453|TWO_SIDED|95.0|-4.428|2.642|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 6 was calculated between GMRx2 and dual-AI arms.||2.642|-4.428|0.7453
71784288|NCT04518293|143067464|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.12||||0.9415|TWO_SIDED|95.0|-3.657|3.222|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TA arms.||3.222|-3.657|0.9415
71677127|NCT03467217|142872658|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.53|TWO_SIDED|95.0|-10.3|19.8|||ANCOVA|Adjusted for the baseline AST value.||||19.8|-10.3|0.53
71784289|NCT04518293|143067464|OTHER||Risk Difference (RD)|-2.53||||0.1719|TWO_SIDED|95.0|-6.799|1.019|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-TI arms.||1.019|-6.799|0.1719
71784290|NCT04518293|143067464|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.16||||0.2342|TWO_SIDED|95.0|-6.38|1.326|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypotension at Week 12 was calculated between GMRx2 and dual-AI arms.||1.326|-6.380|0.2342
71784291|NCT04518293|143067465|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.87||||0.3548|TWO_SIDED|95.0|-9.316|3.215|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TA arms.||3.215|-9.316|0.3548
71784292|NCT04518293|143067465|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.94||||0.7529|TWO_SIDED|95.0|-5.356|6.8|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-TI arms.||6.800|-5.356|0.7529
71784293|NCT04518293|143067465|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-2.32||||0.4563|TWO_SIDED|95.0|-8.791|3.772|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 6 was calculated between GMRx2 and dual-AI arms.||3.772|-8.791|0.4563
71784294|NCT04518293|143067466|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|0.11||||0.9691|TWO_SIDED|95.0|-6.063|5.859|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TA arms.||5.859|-6.063|0.9691
71784295|NCT04518293|143067466|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-3.59||||0.2454|TWO_SIDED|95.0|-10.018|2.462|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-TI arms.||2.462|-10.018|0.2454
71784296|NCT04518293|143067466|OTHER|95% CI for risk difference utilized Newcombe estimation method.|Risk Difference (RD)|-0.33||||0.913|TWO_SIDED|95.0|-6.583|5.488|||Wald test|||The Risk difference (95% CI) in percentage of participants with orthostatic hypertension at Week 12 was calculated between GMRx2 and dual-AI arms.||5.488|-6.583|0.9130
71784297|NCT01146418|143067493|SUPERIORITY_OR_OTHER_LEGACY||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-6.5|3.0|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.0|-6.5|
71784298|NCT01146418|143067494|SUPERIORITY_OR_OTHER_LEGACY||Estimated difference|-1.2|||||TWO_SIDED|95.0|-5.7|3.4|||Clopper-Pearson method|Difference calculated using generalized linear model including covariates for treatment group and age class as stratified (≤38 yrs vs \>38 yrs)||||3.4|-5.7|
71784299|NCT03789474|143067495|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||.443
71784300|NCT03789474|143067496|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||.063
71784301|NCT03789474|143067497|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||||||.057
71784302|NCT03789474|143067498|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||.038
71677128|NCT03467217|142872659|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.57|TWO_SIDED|95.0|-20.8|37.5|||ANCOVA|Adjusted for the baseline ALT value.||||37.5|-20.8|0.57
71784303|NCT03789474|143067499|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||.072
71784304|NCT03789474|143067500|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||.189
71784305|NCT03789474|143067501|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||.358
71784306|NCT03789474|143067502|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||.406
71784307|NCT03789474|143067503|SUPERIORITY|||||||0.256|||||||t-test, 2 sided|||||||.256
71784308|NCT03789474|143067504|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
71784309|NCT03789474|143067505|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||||||.316
71784310|NCT03789474|143067506|SUPERIORITY|||||||0.971|||||||t-test, 2 sided|||||||.971
71677129|NCT03467217|142872660|SUPERIORITY|Adjusted for the baseline ALT value.|Mean Difference (Final Values)|11.6||||0.25|TWO_SIDED|95.0|9.7|36.7|||ANCOVA|||||36.7|9.7|0.25
71784311|NCT03789474|143067507|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
71784312|NCT03789474|143067508|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||.009
71784313|NCT03789474|143067509|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||.704
71669218|NCT00780338|142855397|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
71752532|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||0.0003||95.0|0.406|1.362|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.362|0.406|0.0003
71752533|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.877||||0.0006||95.0|0.375|1.379|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.379|0.375|0.0006
71752534|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.873||||0.0009||95.0|0.356|1.39|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.390|0.356|0.0009
71752535|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.866||||0.002||95.0|0.318|1.414|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.414|0.318|0.0020
71752536|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.862||||0.0029||95.0|0.295|1.428|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.428|0.295|0.0029
71752537|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.854||||0.0055||95.0|0.251|1.457|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.457|0.251|0.0055
71752538|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0076||95.0|0.226|1.475|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.475|0.226|0.0076
71752539|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.843||||0.0129||95.0|0.179|1.508|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.508|0.179|0.0129
71752540|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.839||||0.0168||95.0|0.151|1.527|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.527|0.151|0.0168
71752541|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.832||||0.0257||95.0|0.101|1.563|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.563|0.101|0.0257
71752542|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.828||||0.0318||95.0|0.072|1.583|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.583|0.072|0.0318
71752543|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.821||||0.0447||95.0|0.019|1.622|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.622|0.019|0.0447
71784314|NCT03789474|143067510|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
71784315|NCT03789474|143067511|SUPERIORITY|||||||0.708|||||||t-test, 2 sided|||||||.708
71784316|NCT03789474|143067512|SUPERIORITY|||||||0.711|||||||t-test, 2 sided|||||||.711
71784317|NCT03789474|143067513|SUPERIORITY|||||||0.956|||||||t-test, 2 sided|||||||.956
71784318|NCT03789474|143067514|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||.139
71784319|NCT03789474|143067515|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||.035
71784320|NCT03789474|143067516|SUPERIORITY|||||||0.502|||||||t-test, 2 sided|||||||.502
71784321|NCT03789474|143067517|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.350
71784322|NCT03789474|143067518|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.380
71784323|NCT03789474|143067519|SUPERIORITY|||||||0.914|||||||t-test, 2 sided|||||||.914
71784324|NCT03789474|143067520|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|||||||.915
71784325|NCT03789474|143067521|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||.087
71784326|NCT03789474|143067522|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||.011
71784327|NCT03789474|143067523|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||.207
71784328|NCT03789474|143067524|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
71784329|NCT03789474|143067525|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||||||.021
71784330|NCT03789474|143067526|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71784331|NCT03789474|143067527|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.030
71784332|NCT03789474|143067528|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
71784333|NCT03789474|143067529|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
71891815|NCT01552057|143305344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0408|TWO_SIDED|95.0|-0.74|-0.02||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||||-0.02|-0.74|0.0408
71784334|NCT03789474|143067530|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
71784335|NCT03789474|143067531|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
71784336|NCT03789474|143067532|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
71784337|NCT03789474|143067533|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.020
71784338|NCT03789474|143067534|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
71784339|NCT03789474|143067535|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
71784340|NCT03789474|143067536|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||.746
71784341|NCT03789474|143067537|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
71784342|NCT03789474|143067538|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
71784343|NCT03789474|143067539|SUPERIORITY|||||||0.043|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.043
71784344|NCT03789474|143067540|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.160
71784345|NCT05425745|143067637|SUPERIORITY||Least Squares (LS) Means|-36.31|STANDARD_ERROR_OF_MEAN|3.019|<|0.0001|TWO_SIDED|95.0|-42.22|-30.39|||ANCOVA|||||-30.39|-42.22|<.0001
71784346|NCT05425745|143067638|SUPERIORITY||Least Squares (LS) Means|-37.78|STANDARD_ERROR_OF_MEAN|3.572|<|0.0001|TWO_SIDED|95.0|-44.79|-30.78|||ANCOVA|||||-30.78|-44.79|<.0001
71784347|NCT05425745|143067639|SUPERIORITY||Least Squares (LS) Means|-41.45|STANDARD_ERROR_OF_MEAN|4.938|<|0.0001|TWO_SIDED|95.0|-51.14|-31.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-31.76|-51.14|<.0001
71784348|NCT05425745|143067640|SUPERIORITY||Least Squares (LS) Means|-24.39|STANDARD_ERROR_OF_MEAN|2.136|<|0.0001|TWO_SIDED|95.0|-28.58|-20.2||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.20|-28.58|<.0001
71784349|NCT05425745|143067641|SUPERIORITY||Least Squares (LS) Means|-24.32|STANDARD_ERROR_OF_MEAN|2.583|<|0.0001|TWO_SIDED|95.0|-29.38|-19.25||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.25|-29.38|<.0001
71784350|NCT05425745|143067642|SUPERIORITY||Least Squares (LS) Means|-25.77|STANDARD_ERROR_OF_MEAN|3.114|<|0.0001|TWO_SIDED|95.0|-31.88|-19.67||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.67|-31.88|<.0001
71784351|NCT05425745|143067643|SUPERIORITY||Least Squares (LS) Means|-34.45|STANDARD_ERROR_OF_MEAN|2.661|<|0.0001|TWO_SIDED|95.0|-39.67|-29.24||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-29.24|-39.67|<.0001
71784352|NCT05425745|143067644|SUPERIORITY||Least Squares (LS) Means|-33.0|STANDARD_ERROR_OF_MEAN|3.241|<|0.0001|TWO_SIDED|95.0|-39.36|-26.65||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.65|-39.36|<.0001
71784353|NCT05425745|143067645|SUPERIORITY||Least Squares (LS) Means|-37.48|STANDARD_ERROR_OF_MEAN|4.535|<|0.0001|TWO_SIDED|95.0|-46.38|-28.58||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||-28.58|-46.38|<.0001
71784354|NCT05425745|143067646|SUPERIORITY||Least Squares (LS) Means|138.66|STANDARD_ERROR_OF_MEAN|6.244|<|0.0001|TWO_SIDED|95.0|126.42|150.9||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||150.90|126.42|<.0001
71784355|NCT05425745|143067647|SUPERIORITY||Least Squares (LS) Means|131.2|STANDARD_ERROR_OF_MEAN|6.595|<|0.0001|TWO_SIDED|95.0|118.27|144.13||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||144.13|118.27|<.0001
71784356|NCT05425745|143067648|SUPERIORITY||Least Squares (LS) Means|121.39|STANDARD_ERROR_OF_MEAN|7.333|<|0.0001|TWO_SIDED|95.0|107.02|135.76||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05|ANCOVA|||||135.76|107.02|<.0001
71784357|NCT05425745|143067649|SUPERIORITY||Least Squares (LS) Means|-45.94|STANDARD_ERROR_OF_MEAN|10.14|<|0.0001|TWO_SIDED|95.0|-65.88|-26.0||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.00|-65.88|<.0001
71784358|NCT05425745|143067650|SUPERIORITY||Least Squares (LS) Means|-54.3|STANDARD_ERROR_OF_MEAN|38.924||0.1648|TWO_SIDED|95.0|-131.13|22.53||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||22.53|-131.13|0.1648
71784359|NCT05231954|143067657|SUPERIORITY||Odds Ratio (OR)|1.29||||0.006|TWO_SIDED|95.0|1.08|1.55||P-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.55|1.08|0.006
71891816|NCT05127486|143305355|SUPERIORITY||Odds Ratio (OR)|1.06||||0.695|TWO_SIDED|95.0|0.81|1.38|||pseudo likelihood-based repeated measure|||||1.38|0.81|0.695
71891817|NCT05127486|143305356|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.89|1.56|||pseudo likelihood-based repeated measure|||||1.56|0.89|
71891818|NCT05127486|143305357|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.89|1.79|||pseudo likelihood-based repeated measure|||||1.79|0.89|
71752544|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.817||||0.0529||95.0|-0.01|1.643|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.643|-0.010|0.0529
71752545|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.809||||0.0696||95.0|-0.065|1.683|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.683|-0.065|0.0696
71752546|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.805||||0.0797||95.0|-0.095|1.706|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.706|-0.095|0.0797
71752547|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.798||||0.0994||95.0|-0.151|1.747|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.747|-0.151|0.0994
71784360|NCT05231954|143067657|SUPERIORITY||Odds Ratio (OR)|0.82||||0.081|TWO_SIDED|95.0|0.65|1.03||The p-value is adjusted for multiple comparisons, and a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.03|0.65|0.081
71784361|NCT05231954|143067658|SUPERIORITY||Odds Ratio (OR)|1.44||||0.044|TWO_SIDED|95.0|1.01|2.05||The p-value is adjusted for multiple comparisons, and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||2.05|1.01|0.044
71784362|NCT05231954|143067658|SUPERIORITY||Odds Ratio (OR)|1.02||||0.919|TWO_SIDED|95.0|0.69|1.5||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05|Mixed Models Analysis|||||1.50|0.69|0.919
71784363|NCT00279591|143067667|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Fisher Exact|||||||0.03
71784364|NCT02990910|143067670|SUPERIORITY||||||<|0.05|||||||Chi-squared|||Chi square test was used to compare the count data,p \< 0.05 was considered statistically significant.||||<0.05
71784365|NCT00583778|143067674|SUPERIORITY||Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using STATA 10 SE.Categorical variables were described using frequencies and relative frequencies. Distribution of continuous variables were evaluated for normality using the Shapiro-Walk test and graphically using histograms and box plots. Because most data were non-parametric, they were described using the median and 25th and 75th percentiles (interquartile range) and then compared using Wilcoxon rank sum test.|This study was designed to detect an absolute difference of 12 % in change of FEV-1percent predicted, with a standard deviation of 25% based on data provided to us from previous studies conducted by Sepracor. Based on this assumption, we sought to enter 76 patients in each group to have an 80% power to detect a 12 % absolute difference in charge of FEV-1 percent predicted over time at an alpha of 0.05. This accounted for a potential 10% dropout rate after randomization.|||< 0.05
71813111|NCT03720938|143128562|SUPERIORITY|||||||0||||||The outcome of visual reaction time of non-dominant hand was tested for any difference between groups.|ANCOVA|Adjusted for the visual reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.000
71891819|NCT05127486|143305358|SUPERIORITY||LS Mean difference|-0.37|||||TWO_SIDED|95.0|-0.82|0.09|||Mixed Models Analysis|||||0.09|-0.82|
71752548|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.794||||0.111||95.0|-0.182|1.77|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.770|-0.182|0.1110
71752549|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.787||||0.1328||95.0|-0.239|1.813|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.813|-0.239|0.1328
71752550|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.783||||0.1454||95.0|-0.271|1.836|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.836|-0.271|0.1454
71752551|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.776||||0.1686||95.0|-0.329|1.88|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.880|-0.329|0.1686
71752552|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.771||||0.1817||95.0|-0.361|1.904|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.904|-0.361|0.1817
71891820|NCT05127486|143305359|SUPERIORITY||LS Mean difference|-0.55|||||TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||||0.00|-1.11|
71891821|NCT05127486|143305360|SUPERIORITY||LS Mean difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|||||0.18|-0.90|
71891822|NCT05127486|143305361|SUPERIORITY||LS Mean difference|-0.18|||||TWO_SIDED|95.0|-0.73|0.37|||Mixed Models Analysis|||||0.37|-0.73|
71836239|NCT03978871|143178195|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.76||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = -.3047||||||0.76
71845406|NCT01478594|143205114|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.597|||||TWO_SIDED|95.0|0.672|3.795|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.795|0.672|
71891823|NCT05127486|143305362|SUPERIORITY||LS Mean difference|-0.49|||||TWO_SIDED|95.0|-0.86|-0.11|||Mixed Models Analysis|||||-0.11|-0.86|
71784366|NCT00790023|143067675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|||<|0.0001|TWO_SIDED|95.0|0.57|1.32||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.32|0.57|<0.0001
71784367|NCT00790023|143067675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.0001|TWO_SIDED|95.0|0.7|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.||1.45|0.70|<0.0001
71784368|NCT00790023|143067676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.5|1.25|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.25|0.50|<0.0001
71784369|NCT00790023|143067676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||<|0.0001|TWO_SIDED|95.0|0.63|1.37|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||1.37|0.63|<0.0001
71784370|NCT00790023|143067677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.0004|TWO_SIDED|95.0|0.28|0.95|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.95|0.28|0.0004
71784371|NCT00790023|143067677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.0005|TWO_SIDED|95.0|0.27|0.94|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.94|0.27|0.0005
71784372|NCT01652703|143067707|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.61|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-74.51|-62.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-62.71|-74.51|<0.001
71784373|NCT01652703|143067707|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.85|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-58.84|-46.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-46.86|-58.84|<0.001
71784374|NCT01652703|143067707|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.94|STANDARD_ERROR_OF_MEAN|3.18|<|0.001|TWO_SIDED|95.0|-70.23|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-57.66|-70.23|<0.001
71784375|NCT01652703|143067707|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.16|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-64.51|-51.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.81|-64.51|<0.001
71784376|NCT01652703|143067708|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-96.3|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-106.0|-86.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-86.5|-106.0|<0.001
71784377|NCT01652703|143067708|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-75.5|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-85.4|-65.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-65.5|-85.4|<0.001
71784378|NCT01652703|143067708|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-88.2|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-97.4|-79.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-79.0|-97.4|<0.001
71784379|NCT01652703|143067708|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-80.7|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|-90.0|-71.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-71.4|-90.0|<0.001
71784380|NCT01652703|143067709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1945.68|||<|0.001|TWO_SIDED|95.0|89.64|42232.63||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||42232.63|89.64|<0.001
71784381|NCT01652703|143067709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|281.13|||<|0.001|TWO_SIDED|95.0|14.74|5360.92||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference|||5360.92|14.74|<0.001
71784382|NCT01652703|143067709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|536.45|||<|0.001|TWO_SIDED|95.0|28.37|10143.4||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||10143.40|28.37|<0.001
71752553|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764||||0.2055||95.0|-0.419|1.948|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.948|-0.419|0.2055
71784383|NCT01652703|143067709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|595.59|||<|0.001|TWO_SIDED|95.0|31.11|11402.67||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference|||11402.67|31.11|<0.001
71752554|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76||||0.2188||95.0|-0.452|1.972|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||1.972|-0.452|0.2188
71752555|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753||||0.2427||95.0|-0.51|2.016|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.016|-0.510|0.2427
71752556|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.749||||0.2559||95.0|-0.543|2.041|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.041|-0.543|0.2559
71752557|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.742||||0.2794||95.0|-0.602|2.086|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.086|-0.602|0.2794
71752558|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.738||||0.2923||95.0|-0.635|2.111|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.111|-0.635|0.2923
71752559|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.3152||95.0|-0.695|2.156|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.156|-0.695|0.3152
71752560|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.726||||0.3276||95.0|-0.728|2.181|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.181|-0.728|0.3276
71752561|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719||||0.3497||95.0|-0.788|2.227|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.227|-0.788|0.3497
71752562|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.715||||0.3616||95.0|-0.822|2.252|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.252|-0.822|0.3616
71752563|NCT00083889|143008015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.708||||0.3827||95.0|-0.882|2.298|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G EWB subscale baseline score (intercept and time since randomization are included as random effects)||2.298|-0.882|0.3827
71752564|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.897|||<|0.0001|TWO_SIDED|95.0|1.261|2.533|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).||2.533|1.261|<.0001
71836240|NCT03978871|143178196|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 15 ROIs in the FPN of a modified Schaefer atlas and the 30 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.048||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.998, p = .048||||||.048
71669219|NCT00780338|142855398|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.09
71784384|NCT01652703|143067710|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.56|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-67.85|-57.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-57.27|-67.85|<0.001
71784385|NCT01652703|143067710|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.46|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|-54.83|-44.08||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-44.08|-54.83|<0.001
71784386|NCT01652703|143067710|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-58.08|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.93|-52.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-52.22|-63.93|<0.001
71784387|NCT01652703|143067710|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.54|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-59.46|-47.63||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.63|-59.46|<0.001
71784388|NCT01652703|143067711|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.69|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-65.67|-55.72||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.72|-65.67|<0.001
71784389|NCT01652703|143067711|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.75|STANDARD_ERROR_OF_MEAN|2.56|<|0.001|TWO_SIDED|95.0|-51.8|-41.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.70|-51.80|<0.001
71784390|NCT01652703|143067711|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-58.91|-47.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-47.97|-58.91|<0.001
71677130|NCT03467217|142872661|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.05|TWO_SIDED|95.0|0.0|6.8|||ANCOVA|Adjusted for the baseline HOMA-IR value.||||6.8|0.0|0.05
71784391|NCT01652703|143067711|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.37|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-52.9|-41.85||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.85|-52.90|<0.001
71784392|NCT01652703|143067712|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-34.49|STANDARD_ERROR_OF_MEAN|11.75||0.004|TWO_SIDED|95.0|-57.71|-11.26||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.26|-57.71|0.004
71784393|NCT01652703|143067712|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.25|STANDARD_ERROR_OF_MEAN|11.93||0.044|TWO_SIDED|95.0|-47.83|-0.68||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-0.68|-47.83|0.044
71784394|NCT01652703|143067712|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.82|STANDARD_ERROR_OF_MEAN|9.36||0.002|TWO_SIDED|95.0|-48.32|-11.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-11.32|-48.32|0.002
71784395|NCT01652703|143067712|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.82|STANDARD_ERROR_OF_MEAN|9.41||0.028|TWO_SIDED|95.0|-39.41|-2.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-2.22|-39.41|0.028
71784396|NCT01652703|143067713|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.98|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-52.21|-41.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.76|-52.21|<0.001
71784397|NCT01652703|143067713|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-37.22|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-42.52|-31.91||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-31.91|-42.52|<0.001
71784398|NCT01652703|143067713|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-46.66|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.32|-41.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.00|-52.32|<0.001
71784399|NCT01652703|143067713|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.3|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.02|-39.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-39.58|-51.02|<0.001
71784400|NCT01652703|143067714|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-61.35|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-67.14|-55.56||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-55.56|-67.14|<0.001
71784401|NCT01652703|143067714|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-47.53|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-53.41|-41.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-41.65|-53.41|<0.001
71677131|NCT03467217|142872662|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.64|TWO_SIDED|95.0|-1.5|2.5|||ANCOVA|Adjusted for the baseline weight value.||||2.5|-1.5|0.64
71669220|NCT00780338|142855399|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.01
71669221|NCT00780338|142855400|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
71784402|NCT01652703|143067714|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-63.73|-51.77||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-51.77|-63.73|<0.001
71784403|NCT01652703|143067714|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.22|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|-58.27|-46.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|||-46.18|-58.27|<0.001
71784404|NCT02155608|143067719|SUPERIORITY|||||||0.54||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .38, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.54
71784405|NCT02155608|143067719|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance|Mixed Models Analysis|Time: F=39.97, df = 1/228||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
71784406|NCT02155608|143067719|SUPERIORITY|||||||0.005||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 8.12, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.005
71836241|NCT03978871|143178197|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.833|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation). This is a test of between by within-subjects interaction effect.||||0.833
71836242|NCT03978871|143178198|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.321|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group effect (Growth Mindset vs. Brain Education) across self-reported affect on the SET task. This is a test of between-subjects effect.||||0.321
71836243|NCT03978871|143178199|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.002|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) for fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.002
71891824|NCT05127486|143305363|SUPERIORITY||LS Mean difference|4.39|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|95.0|1.42|7.37|||ANCOVA|||Total score||7.37|1.42|
71677132|NCT03467217|142872663|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.98|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|Adjusted for the baseline BMI value.||||0.6|-0.6|0.98
71677133|NCT03467217|142872664|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.1|TWO_SIDED|95.0|-0.5|5.3|||ANCOVA|Adjusted for the baseline waist circumference value.||||5.3|-0.5|0.10
71784407|NCT02155608|143067719|SUPERIORITY||||||<|0.0001||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time2: F = 28.96, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||<.0001
71784408|NCT02155608|143067719|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 6.23, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.02
71891825|NCT05127486|143305363|SUPERIORITY||LS Mean difference|5.24|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|1.9|8.58|||ANCOVA|||RF-R||8.58|1.90|
71891826|NCT05127486|143305363|SUPERIORITY||LS Mean difference|3.88|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|1.06|6.71|||ANCOVA|||RF-P||6.71|1.06|
71891827|NCT05127486|143305363|SUPERIORITY||LS Mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|95.0|-0.08|6.44|||ANCOVA|||EF||6.44|-0.08|
71784409|NCT02155608|143067719|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 4.18, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
71891828|NCT05127486|143305364|SUPERIORITY||LS Mean difference|-2.43|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-6.94|2.08|||ANCOVA|||||2.08|-6.94|
71752565|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.924|||<|0.0001||95.0|1.309|2.539|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.539|1.309|<.0001
71752566|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.939|||<|0.0001||95.0|1.331|2.546|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.546|1.331|<.0001
71752567|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.965|||<|0.0001||95.0|1.363|2.568|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.568|1.363|<.0001
71891829|NCT03193866|143305370|SUPERIORITY||Difference in proportion|1.5|||||TWO_SIDED|95.0|-1.8|4.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.9|-1.8|
71891830|NCT03193866|143305370|SUPERIORITY||Difference in proportion|-0.2|||||TWO_SIDED|95.0|-6.8|6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.5|-6.8|
71752568|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98|||<|0.0001||95.0|1.376|2.584|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.584|1.376|<.0001
71784410|NCT02155608|143067719|SUPERIORITY|||||||0.73||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .12, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
71891831|NCT03193866|143305370|SUPERIORITY||Difference in proportion|1.3|||||TWO_SIDED|95.0|-1.7|4.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.3|-1.7|
71891832|NCT03193866|143305370|SUPERIORITY||Difference in proportion|-0.9|||||TWO_SIDED|95.0|-4.3|2.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.4|-4.3|
71891833|NCT03193866|143305370|SUPERIORITY||Difference in proportion|1.7|||||TWO_SIDED|95.0|-1.3|4.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|-1.3|
71677134|NCT03467217|142872665|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.08|TWO_SIDED|95.0|0.0|0.05|||ANCOVA|Adjusted for the baseline waist-to-hip ratio.||||0.05|0.00|0.08
71752569|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.007|||<|0.0001||95.0|1.392|2.622|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.622|1.392|<.0001
71752570|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.022|||<|0.0001||95.0|1.396|2.647|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.647|1.396|<.0001
71784411|NCT02155608|143067720|SUPERIORITY|||||||0.003||||||p \< .05 for statistical significance|Chi-squared|Group: F = 8.75, df = 1/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.003
71784412|NCT02155608|143067720|SUPERIORITY|||||||0.17||||||p \< .05 for statistical significance.|Chi-squared|Time: F = 1.69, df = 3/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.||||.17
71677135|NCT03467217|142872666|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.29|TWO_SIDED|95.0|-2.8|9.0|||ANCOVA|Adjusted for the baseline PedsQOL Physical Health score.||||9.0|-2.8|0.29
71677136|NCT03467217|142872667|SUPERIORITY|||||||0.17|||||||Exact conditional binomial test|||||||0.17
71784413|NCT02155608|143067720|SUPERIORITY|||||||0.46|||||||Chi-squared|Group: Chi-square = .53, df = 1.||Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline.||||.46
71784414|NCT02155608|143067721|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|Group: F=.01; df =1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.91
71784415|NCT02155608|143067721|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F=13.03; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.0004
71784416|NCT02155608|143067721|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|Group \* time: F = .83; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.37
71784417|NCT02155608|143067721|SUPERIORITY|||||||0.007||||||Time2: F = 7.45, df = 1/209.|Mixed Models Analysis|||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.||||.007
71784418|NCT02155608|143067721|SUPERIORITY|||||||0.67||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .19, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.67
71784419|NCT02155608|143067721|SUPERIORITY|||||||0.68||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .17, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.68
71784420|NCT02155608|143067721|SUPERIORITY|||||||0.16||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.05, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.16
71784421|NCT02155608|143067722|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
71784422|NCT02155608|143067722|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.12, df = .15||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.15
71784423|NCT02155608|143067722|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .21, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
71784424|NCT02155608|143067722|SUPERIORITY|||||||0.66||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .20, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.66
71784425|NCT02155608|143067722|SUPERIORITY|||||||0.48||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .50, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.48
71784426|NCT02155608|143067722|SUPERIORITY|||||||0.81||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.81
71784427|NCT02155608|143067723|SUPERIORITY|||||||0.89||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .02, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.89
71784428|NCT02155608|143067723|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.28, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.14
71836244|NCT03978871|143178199|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.005|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons included as a covariate.||||0.005
71836245|NCT03978871|143178200|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.033|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on fixed emotion mindset scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||.033
71784429|NCT02155608|143067723|SUPERIORITY|||||||0.8||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .06, df = .81.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.80
71784430|NCT02155608|143067723|SUPERIORITY|||||||0.93||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.93
71784431|NCT02155608|143067723|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.22, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
71669222|NCT00780338|142855401|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.45
71896222|NCT01709799|143314379|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||P-value is not adjusted for multiple comparisons, and p \< .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,115.593)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value \> .05)||||0.498
71669223|NCT00780338|142855402|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.65
71784432|NCT02155608|143067723|SUPERIORITY|||||||0.28||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.23, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.28
71784433|NCT02155608|143067724|SUPERIORITY|||||||0.91||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01; df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.91
71784434|NCT02155608|143067724|SUPERIORITY|||||||0.11||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.62, df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.11
71784435|NCT02155608|143067724|SUPERIORITY|||||||0.4||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .71; df = .40.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.40
71784436|NCT02155608|143067724|SUPERIORITY|||||||0.49||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .48. df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.49
71784437|NCT02155608|143067724|SUPERIORITY|||||||0.18||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.87, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.18
71784438|NCT02155608|143067724|SUPERIORITY|||||||0.72||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .13, df = 1/38.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.72
71784439|NCT02155608|143067725|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|Group: F =.25, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.62
71784440|NCT02155608|143067725|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|Time: F = 3.58, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.06
71784441|NCT02155608|143067725|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 2.90, df 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.09
71784442|NCT02155608|143067725|SUPERIORITY|||||||0.06||||||p \< .05 for statistical significance|Mixed Models Analysis|Group: F = 3.36, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.06
71784443|NCT02155608|143067725|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.20, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
71784444|NCT02155608|143067725|SUPERIORITY|||||||0.42||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .66, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.42
71784445|NCT02155608|143067726|SUPERIORITY|||||||0.29||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 0.29, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.29
71784446|NCT02155608|143067726|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.83, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
71784447|NCT02155608|143067726|SUPERIORITY|||||||0.31||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.03, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.31
71784448|NCT02155608|143067726|SUPERIORITY|||||||0.69||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.69
71784449|NCT02155608|143067726|SUPERIORITY|||||||0.33||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .98, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.33
71896223|NCT00435539|143314380|SUPERIORITY_OR_OTHER|||||||0.4783|||||||Fisher Exact|||||||0.4783
71752571|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.048|||<|0.0001||95.0|1.397|2.7|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.700|1.397|<.0001
71752572|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.063|||<|0.0001||95.0|1.394|2.732|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.732|1.394|<.0001
71752573|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|||<|0.0001||95.0|1.383|2.797|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.797|1.383|<.0001
71752574|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.105|||<|0.0001||95.0|1.374|2.836|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.836|1.374|<.0001
71752575|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.132|||<|0.0001||95.0|1.353|2.91|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.910|1.353|<.0001
71752576|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.146|||<|0.0001||95.0|1.339|2.954|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||2.954|1.339|<.0001
71752577|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.173|||<|0.0001||95.0|1.311|3.036|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.036|1.311|<.0001
71752578|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.188|||<|0.0001||95.0|1.294|3.082|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.082|1.294|<.0001
71752579|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.215|||<|0.0001||95.0|1.26|3.169|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.169|1.260|<.0001
71752580|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|||<|0.0001||95.0|1.241|3.219|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.219|1.241|<.0001
71752581|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.256|||<|0.0001||95.0|1.203|3.309|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.309|1.203|<.0001
71752582|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.271|||<|0.0001||95.0|1.182|3.361|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.361|1.182|<.0001
71784450|NCT02155608|143067726|SUPERIORITY|||||||0.35||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .88, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.35
71784451|NCT02155608|143067727|SUPERIORITY|||||||0.21||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 1.62, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.21
71784452|NCT02155608|143067727|SUPERIORITY|||||||0.02||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.18, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.02
71784453|NCT02155608|143067727|SUPERIORITY|||||||0.01||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 6.89, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.01
71752583|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.298|||<|0.0001||95.0|1.142|3.454|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.454|1.142|<.0001
71784454|NCT02155608|143067727|SUPERIORITY|||||||0.15||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F= 2.16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.15
71677137|NCT03467217|142872668|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.64|TWO_SIDED|95.0|-13.9|8.7|||ANCOVA|Adjusted for baseline total cholesterol value.||||8.7|-13.9|0.64
71752584|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.313||||0.0001||95.0|1.119|3.507|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.507|1.119|0.0001
71752585|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.0003||95.0|1.076|3.603|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.603|1.076|0.0003
71752586|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.354||||0.0004||95.0|1.052|3.657|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.657|1.052|0.0004
71752587|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.381||||0.0007||95.0|1.008|3.754|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.754|1.008|0.0007
71752588|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.396||||0.0009||95.0|0.983|3.809|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.809|0.983|0.0009
71752589|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.423||||0.0014||95.0|0.938|3.908|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.908|0.938|0.0014
71784455|NCT02155608|143067727|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.15, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
71836246|NCT03978871|143178201|SUPERIORITY|Threshold for statistical significance was p = 0.05||||||0.403|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.403
71677138|NCT03467217|142872669|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.67|TWO_SIDED|95.0|-25.6|39.7|||ANCOVA|Adjusted for baseline triglyceride value.||||39.7|-25.6|0.67
71836247|NCT03978871|143178201|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.19|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.190
71784456|NCT02155608|143067727|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
71784457|NCT02155608|143067728|SUPERIORITY|||||||0.94||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.94
71836248|NCT03978871|143178202|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.784||||||degrees of freedom = 1.|ANOVA|||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.784
71836249|NCT03978871|143178202|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.586|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.586
71836250|NCT03978871|143178203|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.916|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.916
71836251|NCT03978871|143178203|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.343|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.343
71896224|NCT00435539|143314380|SUPERIORITY_OR_OTHER|||||||0.0932|||||||Fisher Exact|||||||0.0932
71896225|NCT00435539|143314380|SUPERIORITY_OR_OTHER|||||||0.0721|||||||Fisher Exact|||||||0.0721
71896226|NCT00435539|143314381|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
71836252|NCT03978871|143178204|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.048
71836253|NCT03978871|143178204|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.153|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on emotional self-efficacy vignette scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lesson was included as a covariate.||||0.153
71669224|NCT00780338|142855403|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.00
71669225|NCT00780338|142855404|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.||||.61
71677139|NCT03467217|142872670|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.45|TWO_SIDED|95.0|-3.4|1.5|||ANCOVA|Adjusted for baseline HDL cholesterol value.||||1.5|-3.4|0.45
71752590|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.438||||0.0017||95.0|0.912|3.963|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||3.963|0.912|0.0017
71752591|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.464||||0.0025||95.0|0.866|4.063|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.063|0.866|0.0025
71752592|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.479||||0.003||95.0|0.84|4.119|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.119|0.840|0.0030
71752593|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.506||||0.0042||95.0|0.792|4.219|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.219|0.792|0.0042
71752594|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.521||||0.0049||95.0|0.766|4.275|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.275|0.766|0.0049
71836254|NCT03978871|143178205|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.566|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.566
71836255|NCT03978871|143178205|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.048|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.048
71677140|NCT03467217|142872671|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.93|TWO_SIDED|95.0|-10.3|9.4|||ANCOVA|Adjusted for baseline LDL cholesterol value.||||9.4|-10.3|0.93
71836256|NCT03978871|143178205|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.266|||||||ANCOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.266
71752595|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.547||||0.0064||95.0|0.718|4.377|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.377|0.718|0.0064
71752596|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.562||||0.0073||95.0|0.691|4.433|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.433|0.691|0.0073
71896227|NCT00435539|143314381|SUPERIORITY_OR_OTHER|||||||0.4762|||||||Fisher Exact|||||||0.4762
71669226|NCT00780338|142855405|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.||||.02
71669227|NCT02023983|142855407|OTHER|||||||0.765|||||||Fisher Exact|||||||0.765
71669228|NCT02023983|142855408|OTHER|||||||1|||||||Fisher Exact|||||||1
71669229|NCT02792517|142855426|OTHER||Least Squares Geometric Mean Ratio|1.04|||||TWO_SIDED|90.0|0.88|1.22|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.22|0.88|
71669230|NCT02792517|142855427|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.14|0.91|
71752597|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.589||||0.0091||95.0|0.643|4.535|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.535|0.643|0.0091
71752598|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.604||||0.0103||95.0|0.616|4.592|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.592|0.616|0.0103
71752599|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.631||||0.0125||95.0|0.567|4.695|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.695|0.567|0.0125
71752600|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.645||||0.0138||95.0|0.539|4.752|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.752|0.539|0.0138
71784458|NCT02155608|143067728|SUPERIORITY|||||||0.76||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .09, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.76
71784459|NCT02155608|143067728|SUPERIORITY|||||||0.39||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .75, df =1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.39
71784460|NCT02155608|143067728|SUPERIORITY|||||||0.09||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.06, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.09
71784461|NCT02155608|143067728|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.79
71784462|NCT02155608|143067728|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.55, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.22
71896228|NCT00435539|143314381|SUPERIORITY_OR_OTHER|||||||0.5343|||||||Fisher Exact|||||||0.5343
71669231|NCT02792517|142855428|OTHER||Least Squares Geometric Mean Ratio|1.06|||||TWO_SIDED|90.0|0.97|1.16|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.16|0.97|
71669232|NCT02792517|142855429|OTHER||Least Squares Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.96|1.1|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.10|0.96|
71669233|NCT02792517|142855430|OTHER||Least Squares Geometric Mean Ratio|1.05|||||TWO_SIDED|90.0|0.9|1.23|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.23|0.90|
71784463|NCT02155608|143067729|SUPERIORITY|||||||0.64||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .22, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.64
71784464|NCT02155608|143067729|SUPERIORITY|||||||0.19||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.19
71784465|NCT02155608|143067729|SUPERIORITY|||||||0.22||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.22
71784466|NCT02155608|143067729|SUPERIORITY|||||||0.05||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.95, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.05
71896229|NCT04328623|143314400|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71752601|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.672||||0.0164||95.0|0.49|4.855|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.855|0.490|0.0164
71752602|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.687||||0.0179||95.0|0.462|4.912|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||4.912|0.462|0.0179
71752603|NCT00083889|143008016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.714||||0.0208||95.0|0.413|5.015|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline FACT-G FWB subscale baseline score (intercept and time since randomization are included as random effects)||5.015|0.413|0.0208
71752604|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049||||0.0004|TWO_SIDED|95.0|0.022|0.076|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).||0.076|0.022|0.0004
71752605|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.075|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|0.022|0.0003
71752606|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.074|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.022|0.0003
71752607|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0003||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0003
71752608|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.0004||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.021|0.0004
71752609|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0005||95.0|0.02|0.071|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.020|0.0005
71752610|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045||||0.0007||95.0|0.019|0.07|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.019|0.0007
71784467|NCT02155608|143067729|SUPERIORITY|||||||0.96||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 0.00, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.96
71784468|NCT02155608|143067729|SUPERIORITY|||||||0.92||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = .01, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.92
71845407|NCT01478594|143205115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.627|||||TWO_SIDED|95.0|0.58|4.564|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.564|0.580|
71752611|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044||||0.0011||95.0|0.017|0.07|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.017|0.0011
71784469|NCT02155608|143067730|SUPERIORITY|||||||0.79||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = .07, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.79
71784470|NCT02155608|143067730|SUPERIORITY|||||||0.3||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.10, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.30
71784471|NCT02155608|143067730|SUPERIORITY|||||||0.03||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 4.61, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.03
71784472|NCT02155608|143067730|SUPERIORITY|||||||0.14||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group: F = 2.24, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.14
71669234|NCT02792517|142855431|OTHER||Least Squares Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.94|1.12|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.||1.12|0.94|
71669235|NCT03743051|142855441|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|1.345|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.718|1.971|||ANOVA|||"To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:~H0w: MWa = MW; H1w: MWa ≠ MWp~Where MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm."||1.971|0.718|<0.0001
71669236|NCT03743051|142855442|SUPERIORITY|The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.|Mean Difference (Final Values)|0.622|STANDARD_ERROR_OF_MEAN|0.434||0.1514|TWO_SIDED|95.0|-0.228|1.472|||ANOVA|||"To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant.~The null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:~H0A: MAa = MAp; H1A: MAa ≠ MAp~Where MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm."||1.472|-0.228|0.1514
71669237|NCT03743051|142855443|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|0.532|<|0.0001|TWO_SIDED|95.0|1.367|3.453|||ANOVA|||||3.453|1.367|<0.0001
71784473|NCT02155608|143067730|SUPERIORITY|||||||0.82||||||p \< .05 for statistical significance.|Mixed Models Analysis|Time: F = .05, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.82
71784474|NCT02155608|143067730|SUPERIORITY|||||||0.07||||||p \< .05 for statistical significance.|Mixed Models Analysis|Group \* time: F = 3.35, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.07
71784475|NCT02155608|143067731|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|Group: F = .36, df = 1/52||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.||||.55
71784476|NCT02155608|143067731|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Time: F = .09, df = 1/52||Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.||||.34
71784477|NCT02155608|143067731|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|Group \* time: F = .06, df = 1/52||Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects.||||.81
71784478|NCT02155608|143067731|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|Group: F = .05, df = 1/59||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.83
71836257|NCT03978871|143178205|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.402|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.402
71784479|NCT02155608|143067731|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|Time: F = 4.52, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.04
71836258|NCT03978871|143178206|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.363|||||||ANOVA|degrees of freedom =1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD proactive engagement from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
71784480|NCT02155608|143067731|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|Group \* time: F = .12, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.73
71784481|NCT02155608|143067732|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.62, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.21
71784482|NCT02155608|143067732|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|Time: F = .74, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.39
71784483|NCT02155608|143067732|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|Time2: F = 1.88, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.18
71752612|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043||||0.0016||95.0|0.016|0.07|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.016|0.0016
71891834|NCT03193866|143305370|SUPERIORITY||Difference in proportion|0.3|||||TWO_SIDED|95.0|-2.7|3.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.7|
71752613|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0029||95.0|0.014|0.07|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.014|0.0029
71752614|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042||||0.0041||95.0|0.013|0.07|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.070|0.013|0.0041
71752615|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.0076||95.0|0.011|0.071|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.011|0.0076
71752616|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.0105||95.0|0.009|0.071|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.071|0.009|0.0105
71752617|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0179||95.0|0.007|0.072|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.007|0.0179
71752618|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039||||0.0236||95.0|0.005|0.072|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.072|0.005|0.0236
71752619|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.037||95.0|0.002|0.073|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.073|0.002|0.0370
71752620|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0464||95.0|0.001|0.074|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.074|0.001|0.0464
71784484|NCT02155608|143067732|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|Group \* time: F = 1.56; df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.||||.22
71891835|NCT03193866|143305370|SUPERIORITY||Difference in proportion|1.2|||||TWO_SIDED|95.0|-2.0|4.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.4|-2.0|
71669238|NCT03743051|142855444|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.336|STANDARD_ERROR_OF_MEAN|0.484||0.0057|TWO_SIDED|95.0|0.388|2.284|||ANOVA|||||2.284|0.388|0.0057
71669239|NCT03743051|142855445|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|1.027|STANDARD_ERROR_OF_MEAN|0.403||0.0108|TWO_SIDED|95.0|0.238|1.816|||ANOVA|||||1.816|0.238|0.0108
71677141|NCT03467217|142872672|SUPERIORITY||Median Difference (Final Values)|2.9||||0.29|TWO_SIDED|95.0|-2.5|20.1|||ANCOVA|Adjusted for baseline PedsQOL Psychosocial Health score.||||20.1|-2.5|0.29
71752621|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.0667||95.0|-0.002|0.075|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.075|-0.002|0.0667
71896230|NCT00479466|143314599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.6|||<|0.001|TWO_SIDED|95.0|-44.0|-17.3|||ANCOVA|||||-17.3|-44.0|<0.001
71669240|NCT03743051|142855446|SUPERIORITY|All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.|Mean Difference (Final Values)|0.535|STANDARD_ERROR_OF_MEAN|0.475||0.2605|TWO_SIDED|95.0|-0.397|1.466|||ANOVA|||||1.466|-0.397|0.2605
71669241|NCT01422200|142855448|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71669242|NCT00811733|142855450|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|21.3|73.4|||||The estimated value represents the percentage of participants with OR.|||73.4|21.3|
71669243|NCT00811733|142855450|SUPERIORITY_OR_OTHER||percentage of participants|68.0|||||TWO_SIDED|95.0|45.1|86.1|||||The estimated value represents the percentage of participants with OR.|||86.1|45.1|
71669244|NCT00811733|142855451|SUPERIORITY_OR_OTHER||percentage of participants|33.0|||||TWO_SIDED|95.0|11.8|61.6|||||The estimated value represents the percentage of participants with OR.|||61.6|11.8|
71752622|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.08||95.0|-0.004|0.076|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.076|-0.004|0.0800
71669245|NCT00811733|142855451|SUPERIORITY_OR_OTHER||percentage of participants|64.0|||||TWO_SIDED|95.0|40.7|82.8|||||The estimated value represents the percentage of participants with OR.|||82.8|40.7|
71752623|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035||||0.107||95.0|-0.007|0.077|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.077|-0.007|0.1070
71784485|NCT02155608|143067732|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.72, df = 1/12.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||.21
71669246|NCT03442751|142855496|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0004|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Repeated measures mixed analysis of covariance model||-0.4|-1.5|0.0004
71669247|NCT03442751|142855497|SUPERIORITY|last observation carried forward was used to impute missing Month 12 data|Mean Difference (Net)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||ANCOVA|||repeated measures mixed analysis of covariance model||-0.6|-1.6|<0.0001
71669248|NCT04583735|142855533|SUPERIORITY||LSMean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.396||0.0004|TWO_SIDED|95.0|-2.28|-0.69||MMRM analysis with an unstructured variance-covariance matrix including change from Baseline value as dependent variable \& covariates: Baseline value, treatment group, visit, visit-by-treatment \& visit-by-Baseline value interactions.|MMRM|||||-0.69|-2.28|0.0004
71669249|NCT02015611|142855561|SUPERIORITY|||||||0.63|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.63
71669250|NCT02015611|142855562|SUPERIORITY|||||||0.64|||||||Regression, Linear|adjusted for age, sex, race, season, and baseline value||||||0.64
71669251|NCT02015611|142855563|SUPERIORITY|||||||0.08|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.08
71669252|NCT02015611|142855564|SUPERIORITY|||||||0.53|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.53
71784486|NCT02155608|143067732|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Time: F = 0.00, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
71669253|NCT02015611|142855565|SUPERIORITY|||||||0.75|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.75
71669254|NCT02015611|142855566|SUPERIORITY|||||||0.92|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.92
71669255|NCT02015611|142855567|SUPERIORITY|||||||0.94|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.94
71669256|NCT02015611|142855568|SUPERIORITY|||||||0.61|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.61
71669257|NCT02015611|142855569|SUPERIORITY|||||||0.59|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.59
71669258|NCT02015611|142855570|SUPERIORITY|||||||0.21|||||||ANCOVA|adjusted for age, sex, race, season (time-varying)||||||0.21
71669259|NCT03737357|142855629|NON_INFERIORITY|The tolerance range or non-inferiority margin characterizes the largest absolute difference which is considered to be dismissible. A MBL of less than 0.5mm within the first year after implant loading constitutes an acceptable clinical standard(10, 18, 19). In this clinical trial, a non-inferiority margin of 20% of the acceptable clinical standard was chosen, which amounts to 0.1mm.|paired difference|0.01||||0.074|TWO_SIDED||||||t-test, 1 sided|Non-inferiority one-sided paired t-tests using a non-inferiority margin of -0.10mm.|The paired difference is (SLActive® bone level change from baseline (CFB) - SLA® CFB (i.e. resorption))||In the PP population, the paired difference between SLActive® and SLA® bone level change from baseline (CFB) was estimated at 0.01 mm with a standard deviation of 0.444 mm (95% CI: -Inf, 0.11; p = 0.074), based on a one-sided paired t-test with a non-inferiority margin of 0.10 mm.|||0.074
71669260|NCT01320293|142855639|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
71669261|NCT01320293|142855640|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||<0.05
71677142|NCT04304235|142872680|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|||||||||||||
71784487|NCT02155608|143067732|SUPERIORITY|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Group \* time: F = .87, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.||||1
71784488|NCT00543140|143067767|SUPERIORITY_OR_OTHER|||||||0.6919|TWO_SIDED|||||No adjustments for multiple comparisons were performed as only one hypothesis was tested in this study. The level of significance was set at 0.05.|Exact Binomial method|||The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.||||0.6919
71784489|NCT03808493|143067791|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the least square means (LS-Means) between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0211|||||TWO_SIDED|90.0|-0.0752|0.0329||||||||0.0329|-0.0752|
71784490|NCT03808493|143067791|EQUIVALENCE|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0019|||||TWO_SIDED|90.0|-0.0778|0.0815||||||||0.0815|-0.0778|
71784491|NCT03808493|143067792|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0698|||||TWO_SIDED|90.0|-0.1404|0.0008||||||||0.0008|-0.1404|
71784492|NCT03808493|143067792|EQUIVALENCE|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0811|||||TWO_SIDED|90.0|-0.1658|0.0036||||||||0.0036|-0.1658|
71784493|NCT03808493|143067793|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0199|||||TWO_SIDED|90.0|-0.0731|0.0333||||||||0.0333|-0.0731|
71784494|NCT03808493|143067793|EQUIVALENCE|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0035|||||TWO_SIDED|90.0|-0.076|0.083||||||||0.0830|-0.0760|
71784495|NCT03808493|143067794|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.1902|||||TWO_SIDED|90.0|0.0199|0.3605||||||||0.3605|0.0199|
71784496|NCT03808493|143067794|EQUIVALENCE|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.2142|||||TWO_SIDED|90.0|0.0558|0.3725||||||||0.3725|0.0558|
71784497|NCT03808493|143067795|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0311|||||TWO_SIDED|90.0|0.0022|0.0599||||||||0.0599|0.0022|
71784498|NCT03808493|143067795|EQUIVALENCE|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0306|||||TWO_SIDED|90.0|-0.0003|0.0616||||||||0.0616|-0.0003|
71836259|NCT03978871|143178206|SUPERIORITY|The threshold for statistical significance was p = 0.05||||||0.363|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.363
71896231|NCT00479466|143314599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6|||<|0.001|TWO_SIDED|95.0|-59.7|-33.4|||ANCOVA|||||-33.4|-59.7|<0.001
71784499|NCT03808493|143067796|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0209|||||TWO_SIDED|90.0|-0.0112|0.053||||||||0.0530|-0.0112|
71784500|NCT03808493|143067796|EQUIVALENCE|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0135|||||TWO_SIDED|90.0|-0.0508|0.0238||||||||0.0238|-0.0508|
71784501|NCT00429273|143067825|OTHER|Test for differences in treatment outcomes between three different tx|F-Value for variance component|18.9|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Analyses are based on a generalized linear mixed model (GLMM) modelling the effects of the medication when calibrated to optimal dosage and controlling for time effects and within-subject effects. The design is a combined within-between subject design, where each participant is exposed to, and provides information about multiple tx modalities.||||<.01
71784502|NCT01438957|143067826|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71784503|NCT01438957|143067826|SUPERIORITY|||||||0.003|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.003
71784504|NCT01438957|143067826|SUPERIORITY|||||||0.086|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.086
71784505|NCT01438957|143067826|SUPERIORITY||||||<|0.001|||||||Mantel-extension test|Stratified by the anesthesia type||Dose-response relationship is assessed using Mantel-extension test. In this analysis, dose of placebo group is hypothesized as 0 microg/kg. Dose-response relationship among Dexmedetomidine 4 dose groups excluding placebo group is also assessed using Mantel-extension test.||||<0.001
71784506|NCT01438957|143067827|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71784507|NCT01438957|143067827|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
71784508|NCT01438957|143067827|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
71784509|NCT01438957|143067827|SUPERIORITY|||||||0.329|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.329
71784510|NCT01438957|143067828|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71784511|NCT01438957|143067828|SUPERIORITY||||||<|0.001|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||<0.001
71784512|NCT01438957|143067828|SUPERIORITY|||||||0.006|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.006
71784513|NCT01438957|143067828|SUPERIORITY|||||||0.371|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||||||0.371
71891836|NCT03193866|143305370|SUPERIORITY||Difference in proportion|2.0|||||TWO_SIDED|95.0|-3.2|7.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.1|-3.2|
71669262|NCT01320293|142855641|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)||||0.05
71669263|NCT00070564|142855662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.32||||0.022|TWO_SIDED|95.0|1.04|1.68|||Log Rank|||||1.68|1.04|0.022
71669264|NCT00070564|142855662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.072|TWO_SIDED|95.0|0.98|1.59|||Log Rank|||||1.59|0.98|0.072
71669265|NCT00070564|142855662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.38|TWO_SIDED|95.0|0.87|1.44|||Log Rank|||||1.44|0.87|0.38
71669266|NCT00070564|142855662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||Log Rank|||||||0.11
71669267|NCT00070564|142855662|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.733|TWO_SIDED|95.0|0.61|1.41|||Log Rank|||||1.41|0.61|0.733
71669268|NCT00070564|142855663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.44||||0.013|TWO_SIDED|95.0|1.08|1.93|||Log Rank|||||1.93|1.08|0.013
71752624|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.1237||95.0|-0.009|0.078|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.078|-0.009|0.1237
71669269|NCT00070564|142855663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.011|TWO_SIDED|95.0|1.09|1.95|||Log Rank|||||1.95|1.09|0.011
71669270|NCT00070564|142855663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.24||||0.17|TWO_SIDED|95.0|0.91|1.68|||Log Rank|||||1.68|0.91|0.17
71669271|NCT00070564|142855663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.040
71669272|NCT00070564|142855663|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.724|TWO_SIDED|95.0|0.54|1.53|||Log Rank|||||1.53|0.54|0.724
71669273|NCT00070564|142855665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||Log Rank|||Overall treatment differences.||||0.67
71752625|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1561||95.0|-0.013|0.079|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.079|-0.013|0.1561
71784514|NCT01438957|143067829|SUPERIORITY||||||<|0.001|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71784515|NCT01438957|143067829|SUPERIORITY|||||||0.001|||||||Log Rank|Stratified by the anesthesia type||||||0.001
71784516|NCT01438957|143067829|SUPERIORITY|||||||0.212|||||||Log Rank|Stratified by the anesthesia type||||||0.212
71669274|NCT00070564|142855665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.42
71669275|NCT00070564|142855666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Log Rank|||Test of overall treatment differences.||||0.90
71669276|NCT00070564|142855666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.52
71669277|NCT00070564|142855667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076|||||||Log Rank|||Test of overall treatment differences.||||0.076
71669278|NCT00070564|142855667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.018
71669279|NCT00070564|142855668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Log Rank|||Test of overall treatment differences.||||0.062
71669280|NCT00070564|142855668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.010
71669281|NCT00070564|142855669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|||Test of overall treatment differences.||||0.69
71669282|NCT00070564|142855669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Log Rank|||Test of interaction two treatments: AC and paclitaxel.||||0.66
71669283|NCT00070564|142855670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||Test of overall treatment differences||||0.40
71669284|NCT00070564|142855670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.||||0.28
71669285|NCT02059512|142855671|SUPERIORITY|||||||0.24|||||||Kruskal-Wallis|||||||0.24
71784517|NCT01438957|143067830|SUPERIORITY|||||||0.869|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.869
71784518|NCT01438957|143067831|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
71784519|NCT01438957|143067832|SUPERIORITY|||||||0.897|TWO_SIDED|5.0|||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.897
71784520|NCT01438957|143067833|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||<0.001
71784521|NCT01438957|143067833|SUPERIORITY|||||||0.002|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.002
71784522|NCT01438957|143067833|SUPERIORITY|||||||0.116|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.116
71752626|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.1752||95.0|-0.015|0.08|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.080|-0.015|0.1752
71752627|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.2112||95.0|-0.018|0.081|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.081|-0.018|0.2112
71752628|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.2319||95.0|-0.02|0.082|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.082|-0.020|0.2319
71752629|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2698||95.0|-0.023|0.084|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.084|-0.023|0.2698
71752630|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.291||95.0|-0.025|0.085|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.085|-0.025|0.2910
71752631|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.3293||95.0|-0.029|0.086|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.086|-0.029|0.3293
71752632|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028||||0.3504||95.0|-0.031|0.087|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.087|-0.031|0.3504
71752633|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.3881||95.0|-0.034|0.089|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.089|-0.034|0.3881
71752634|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.4086||95.0|-0.036|0.09|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.090|-0.036|0.4086
71752635|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.4449||95.0|-0.04|0.091|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.091|-0.040|0.4449
71752636|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.4646||95.0|-0.042|0.092|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.092|-0.042|0.4646
71752637|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.499||95.0|-0.046|0.094|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.094|-0.046|0.4990
71752638|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.5176||95.0|-0.048|0.095|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.095|-0.048|0.5176
71784523|NCT01438957|143067834|SUPERIORITY|||||||0.088|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.088
71669286|NCT02059512|142855672|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of hospital stay.||||0.1
71752639|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023||||0.5501||95.0|-0.051|0.097|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.097|-0.051|0.5501
71784524|NCT01438957|143067835|SUPERIORITY|||||||0.085|||||||Log Rank|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.085
71752640|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.5675||95.0|-0.054|0.098|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.098|-0.054|0.5675
71752641|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.5979||95.0|-0.057|0.099|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.099|-0.057|0.5979
71752642|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021||||0.6141||95.0|-0.059|0.1|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.100|-0.059|0.6141
71784525|NCT01438957|143067836|SUPERIORITY|||||||0.005|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.005
71784526|NCT01438957|143067836|SUPERIORITY|||||||0.014|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.014
71784527|NCT01438957|143067836|SUPERIORITY|||||||0.055|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.055
71784528|NCT01438957|143067837|SUPERIORITY|||||||0.737|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.737
71784529|NCT01438957|143067838|SUPERIORITY|||||||0.11|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.11
71784530|NCT01438957|143067839|SUPERIORITY|||||||0.567|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.567
71669287|NCT02059512|142855672|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||Length of stay in the intensive care unit.||||0.1
71752643|NCT00083889|143008017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.6424||95.0|-0.063|0.102|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-5D Health state index baseline score (intercept and time since randomization are included as random effects)||0.102|-0.063|0.6424
71784531|NCT01438957|143067840|SUPERIORITY|||||||0.044|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.044
71669288|NCT02059512|142855673|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||||||0.4
71669289|NCT02059512|142855673|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Analysis of leukocytes 0-6 hours of the postoperative period.||||0.8
71669290|NCT02059512|142855673|SUPERIORITY|||||||0.9|||||||Kruskal-Wallis|||Analysis of leukocytes 12-18 hours of the postoperative period.||||0.9
71669291|NCT02059512|142855673|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||Analysis of leukocytes 18-24 hours of the postoperative period.||||0.2
71784532|NCT01438957|143067840|SUPERIORITY|||||||0.234|||||||Mantel Haenszel|Stratified by the anesthesia type||||||0.234
71784533|NCT01438957|143067841|SUPERIORITY|||||||0.729|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.729
71784534|NCT01438957|143067842|SUPERIORITY|||||||0.082|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.082
71784535|NCT01438957|143067843|SUPERIORITY|||||||0.451|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.451
71784536|NCT01438957|143067844|SUPERIORITY|||||||0.873|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.873
71784537|NCT01438957|143067845|SUPERIORITY|||||||0.374|||||||Mantel Haenszel|Stratified by the anesthesia type||The closed testing procedure is used taking multiplicity into consideration, in which Dexmedetomidine 1.0 mcg/kg group, 0.5 mcg/kg group, 0.25 mcg/kg group, 0.067 mcg/kg group and the placebo group are tested in this order||||0.374
71784538|NCT02495168|143067847|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance (ANCOVA) model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Referece LS Mean Ratio|101.9|||||TWO_SIDED|90.0|92.7|111.9|||||Fieller's formula was applied to calculate the 90% confidence interval (CI) for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||111.9|92.7|
71896232|NCT00479466|143314599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1|||<|0.001|TWO_SIDED|95.0|-64.3|-38.0|||ANCOVA|||||-38.0|-64.3|<0.001
71836260|NCT03978871|143178206|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.583|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD involuntary dysregulation scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.583
71752644|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.026|||<|0.0001|TWO_SIDED|95.0|2.088|5.965|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline Euro-QoL Visual Analog Scale (EQ-VAS) baseline score (intercept and time since randomization are included as random effects).||5.965|2.088|<.0001
71752645|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.165|||<|0.0001||95.0|2.269|6.061|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.061|2.269|<.0001
71752646|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.243|||<|0.0001||95.0|2.358|6.128|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.128|2.358|<.0001
71752647|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.382|||<|0.0001||95.0|2.494|6.269|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.269|2.494|<.0001
71752648|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.459|||<|0.0001||95.0|2.558|6.361|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.361|2.558|<.0001
71752649|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||<|0.0001||95.0|2.65|6.547|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.547|2.650|<.0001
71752650|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.676|||<|0.0001||95.0|2.689|6.662|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.662|2.689|<.0001
71752651|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.815|||<|0.0001||95.0|2.741|6.889|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||6.889|2.741|<.0001
71752652|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.892|||<|0.0001||95.0|2.76|7.024|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.024|2.760|<.0001
71752653|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.031|||<|0.0001||95.0|2.78|7.283|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.283|2.780|<.0001
71752654|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.109|||<|0.0001||95.0|2.783|7.435|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.435|2.783|<.0001
71752655|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.248|||<|0.0001||95.0|2.776|7.72|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.720|2.776|<.0001
71836261|NCT03978871|143178206|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.379|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.379
71752656|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.325|||<|0.0001||95.0|2.767|7.884|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||7.884|2.767|<.0001
71752657|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.464|||<|0.0001||95.0|2.741|8.188|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.188|2.741|<.0001
71669292|NCT02059512|142855673|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 48 hours of the postoperative period.||||0.5
71669293|NCT02059512|142855673|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 72 hours of the postoperative period.||||0.4
71669294|NCT02059512|142855673|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Analysis of leukocytes 96 hours of the postoperative period/||||0.6
71669295|NCT02059512|142855673|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Analysis of leukocytes 7 days of the postoperative period.||||0.4
71669296|NCT02059512|142855673|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||Analysis of leukocytes 14 days of the postoperative period.||||0.5
71752658|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.542||||0.0001||95.0|2.723|8.361|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.361|2.723|0.0001
71752659|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.681||||0.0002||95.0|2.683|8.679|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.679|2.683|0.0002
71752660|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.758||||0.0003||95.0|2.657|8.859|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||8.859|2.657|0.0003
71752661|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.898||||0.0004||95.0|2.607|9.188|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.188|2.607|0.0004
71752662|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.975||||0.0006||95.0|2.576|9.374|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.374|2.576|0.0006
71752663|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.114||||0.0009||95.0|2.517|9.711|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.711|2.517|0.0009
71784539|NCT02495168|143067848|SUPERIORITY||LS Mean Difference|2.334|||<|0.0001|TWO_SIDED|95.0|1.673|2.996||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||2.996|1.673|<0.0001
71784540|NCT02495168|143067848|SUPERIORITY||LS Mean Difference|2.606|||<|0.0001|TWO_SIDED|95.0|1.939|3.273||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||3.273|1.939|<0.0001
71784541|NCT02495168|143067849|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Reference LS Mean Ratio|99.8|||||TWO_SIDED|90.0|87.0|114.5|||||Fieller's formula was applied to calculate the 90% CI for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.|||114.5|87.0|
71784542|NCT02495168|143067850|SUPERIORITY||LS Mean Difference|0.159|||<|0.0001|TWO_SIDED|95.0|0.093|0.226||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.||0.226|0.093|<0.0001
71784543|NCT02495168|143067850|SUPERIORITY||LS Mean Difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.099|0.229||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.||0.229|0.099|<0.0001
71669297|NCT02059512|142855674|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||CRP initially.||||0.1
71669298|NCT02059512|142855674|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||CRP postoperative 4-6 days.||||0.4
71669299|NCT02059512|142855674|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||CRP postoperative 12-14 days.||||0.99
71669300|NCT02059512|142855675|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||The volume of discharge through the drains on the first day after surgery.||||0.2
71669301|NCT02059512|142855675|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||The volume of discharge through the drains on the second day after the operation.||||0.3
71669302|NCT02059512|142855676|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||Troponin I postoperative day 1.||||0.6
71669303|NCT02059512|142855676|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Troponin I postoperative day 3.||||0.4
71669304|NCT02059512|142855676|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Myoglobin postoperative day 1.||||0.8
71669305|NCT02059512|142855676|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||Myoglobin postoperative day 3.||||0.7
71752664|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.191||||0.0011||95.0|2.482|9.9|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||9.900|2.482|0.0011
71752665|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.331||||0.0015||95.0|2.417|10.244|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.244|2.417|0.0015
71752666|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.408||||0.0018||95.0|2.379|10.436|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.436|2.379|0.0018
71752667|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.547||||0.0025||95.0|2.309|10.785|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.785|2.309|0.0025
71752668|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.624||||0.0029||95.0|2.269|10.98|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||10.980|2.269|0.0029
71752669|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.764||||0.0037||95.0|2.195|11.332|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.332|2.195|0.0037
71752670|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.841||||0.0042||95.0|2.153|11.529|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.529|2.153|0.0042
71752671|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98||||0.0053||95.0|2.076|11.884|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||11.884|2.076|0.0053
71752672|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.057||||0.0059||95.0|2.032|12.083|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.083|2.032|0.0059
71752673|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.197||||0.0072||95.0|1.953|12.441|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.441|1.953|0.0072
71669306|NCT02059512|142855677|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||CPK-MB postoperative day 1.||||0.7
71669307|NCT02059512|142855677|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||CPK-MB postoperative day 3.||||0.8
71752674|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.274||||0.0079||95.0|1.908|12.64|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||12.640|1.908|0.0079
71784544|NCT02270957|143067854|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
71784545|NCT02270957|143067855|SUPERIORITY|||||||0.587|||||||Chi-squared|||||||0.587
71784546|NCT02270957|143067856|SUPERIORITY|||||||0.587|TWO_SIDED|95.0||||None of the endpoints were met in any pre-specified unbiased Full Analysis Set analysis|Chi-squared|||||||0.587
71784547|NCT01774604|143067866|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.33
71784548|NCT01774604|143067867|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71784549|NCT01774604|143067868|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71784550|NCT01774604|143067869|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||0.15
71784551|NCT01774604|143067870|SUPERIORITY_OR_OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
71784552|NCT01774604|143067871|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
71784553|NCT01774604|143067872|SUPERIORITY_OR_OTHER|||||||0.1|||||||Fisher Exact|||||||0.10
71784554|NCT02042183|143067892|OTHER|||||||0.1609||||||Cochran-Mantel-Haenszel (CMH) test stratified by baseline spontaneous bowel movement (SBM) frequency (\<1.5 or ≥1.5)|Cochran-Mantel-Haenszel|||||||0.1609
71784555|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.08|||<|0.001|TWO_SIDED|95.0|1.05|1.11||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.|Regression, Cox||The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF|The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.11|1.05|< 0.001
71813112|NCT03720938|143128562|SUPERIORITY|||||||9e-08||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||0.00000009
71669308|NCT02059512|142855678|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Hb intraoperatively before turning off the cardiopulmonary bypass(CPB).||||1.0
71752675|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.413||||0.0093||95.0|1.826|13.0|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.000|1.826|0.0093
71752676|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.491||||0.0101||95.0|1.78|13.201|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.201|1.780|0.0101
71752677|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63||||0.0117||95.0|1.697|13.562|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.562|1.697|0.0117
71752678|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.707||||0.0126||95.0|1.65|13.764|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||13.764|1.650|0.0126
71752679|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.846||||0.0144||95.0|1.565|14.127|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.127|1.565|0.0144
71752680|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.924||||0.0153||95.0|1.518|14.329|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.329|1.518|0.0153
71752681|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.063||||0.0172||95.0|1.432|14.693|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.693|1.432|0.0172
71752682|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.14||||0.0182||95.0|1.384|14.896|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||14.896|1.384|0.0182
71752683|NCT00083889|143008018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.279||||0.0201||95.0|1.297|15.261|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed-effects model with an intercept term, treatment, time since randomization, treatment-by-time interaction, and baseline EQ-VAS baseline score (intercept and time since randomization are included as random effects)||15.261|1.297|0.0201
71784556|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.02|TWO_SIDED|95.0|1.01|1.08||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.|Regression, Cox||The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF|The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.08|1.01|0.02
71784557|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.56|TWO_SIDED|95.0|0.77|1.61||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of being male on a patient's risk of developing AF.|The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).||1.61|0.77|0.56
71784558|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.66|TWO_SIDED|95.0|0.74|1.59||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.|The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.59|0.74|0.66
71896233|NCT00479466|143314599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.2|||<|0.001|TWO_SIDED|95.0|-74.6|-47.8|||ANCOVA|||||-47.8|-74.6|<0.001
71896234|NCT00479466|143314599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|||<|0.001|TWO_SIDED|95.0|-48.6|-22.4|||ANCOVA|||||-22.4|-48.6|<0.001
71752684|NCT03349723|143008032|OTHER||Slope|0.9806|STANDARD_ERROR_OF_MEAN|0.0322|||TWO_SIDED|95.0|0.9155|1.0457|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0457|0.9155|
71669309|NCT02059512|142855678|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Hb at the end of the operation.||||0.4
71752685|NCT03349723|143008033|OTHER||Slope|0.9892|STANDARD_ERROR_OF_MEAN|0.0339|||TWO_SIDED|95.0|0.9207|1.0577|||||Based on the estimate for the slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|The model consisted of a regression model applied to log-transformed data. The corresponding ANCOVA model included the logarithm of the dose as a covariate.||1.0577|0.9207|
71752686|NCT03409796|143008038|OTHER|||||||0.385|||||||t-test, 1 sided|||Gluten 3 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdBaseline (B) and Vh:Cd15.||||0.385
71752687|NCT03409796|143008038|OTHER|||||||0.003|||||||t-test, 1 sided|||Gluten 10 gram: Baseline versus Day 15. Change in Vh:Cd follows a normal distribution. A 1-sided paired t-test was used to compare Baseline and follow-up Vh:Cd measures. The normality assumption was checked using the Shapiro-Wilk test. If the data was not normal at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare Vh:CdB and Vh:Cd15.||||0.003
71752688|NCT03409796|143008039|OTHER|||||||0.01|||||||Poisson distribution|||Gluten 3 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson generalized linear mixed models (GLMM) was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.010
71752689|NCT03409796|143008039|OTHER|||||||0.006|||||||Poisson distribution|||Gluten 10 gram: Baseline versus Day 15. The Poisson distribution assumption was checked using Kolmogorov-Smirnov test. Poisson GLMM was fitted to data, where IEL measurements were grouped by participant (the random effect) and the change in IEL counts was the fixed effect. If the data was found to not be Poisson at alpha=0.05, a 1-sided Wilcoxon signed-rank test was used instead to compare IELB and IEL15.||||0.006
71752690|NCT01602224|143008055|SUPERIORITY||Odds Ratio (OR)|1.98||||0.401|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.401
71836262|NCT03978871|143178206|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.246|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (pre-manipulation and post-manipulation) on ERD disengagement scores from time 1 to time 3. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.246
71752691|NCT01602224|143008055|SUPERIORITY||Odds Ratio (OR)|1.84||||0.455|TWO_SIDED||||||Regression, Logistic|||300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.||||0.455
71752692|NCT01602224|143008055|SUPERIORITY||Odds Ratio (OR)|1.9||||0.419|TWO_SIDED||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.||||0.419
71752693|NCT01352117|143008057|SUPERIORITY|||||||0.911||||||The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (\<200 vs. \>=200 cells/mm\^3).||||||0.911
71836263|NCT03978871|143178207|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative reframe \> negative immerse) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were then averaged to produce a single value each.A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control)||||||0.455||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = .75||||||0.455
71896235|NCT00479466|143314600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|||<|0.001|TWO_SIDED|95.0|-1.53|-0.76|||ANCOVA|||||-0.76|-1.53|<0.001
71669310|NCT02059512|142855679|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||HCT intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.8
71752694|NCT00770653|143008096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA|||Null hypothesis (H0) = mean increase of HDL after 24 weeks of treatment of Pio/Met group ≤ the mean increase in the Gli/Met group. Alternate hypothesis (H1) = mean increase of HDL after 24 weeks of treatment of Pio/Met group \> the mean increase in the Gli/Met group. The relevant clinical effect size to detect with adequate power was 0.35. With this assumption, a one sided t-test with a type I error rate had 80% power to reject the H0 for the H1 when the sample size was 130 patients per group.||5.3076|1.2264|0.0018
71752695|NCT00770653|143008097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267||||0.0018|TWO_SIDED|95.0|1.2264|5.3076|||ANCOVA||Deviation from the normal distribution assumption was detected for original and rank-transformed data for all time-points due to p-value of Shapiro-Wilk test, indicating the normal distribution assumption might be distrusted for HDL-cholesterol data.|||5.3076|1.2264|0.0018
71752696|NCT00770653|143008098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1311||||0.1167|TWO_SIDED|95.0|-0.2951|0.0329|||ANCOVA|||||0.0329|-0.2951|0.1167
71752697|NCT00770653|143008099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9479||||0.1012|TWO_SIDED|95.0|-39.4331|3.5373|||ANCOVA|||||3.5373|-39.4331|0.1012
71752698|NCT00770653|143008100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1292||||0.7486|TWO_SIDED|95.0|-17.0109|23.2693|||ANCOVA|||||23.2693|-17.0109|0.7486
71752699|NCT00770653|143008101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2355||||0.9464|TWO_SIDED|95.0|-7.1253|6.6543|||ANCOVA|||||6.6543|-7.1253|0.9464
71752700|NCT00770653|143008102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1574||||0.0807|TWO_SIDED|95.0|-0.0193|0.3341|||ANCOVA|||||0.3341|-0.0193|0.0807
71752701|NCT00770653|143008103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5039|||<|0.0001|TWO_SIDED|95.0|-6.4222|-2.5855|||ANCOVA|||||-2.5855|-6.4222|<.0001
71752702|NCT00770653|143008104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0707||||0.7799|TWO_SIDED|95.0|-6.4665|8.6079|||ANCOVA|||||8.6079|-6.4665|0.7799
71752703|NCT00770653|143008105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3161|||<|0.0001|TWO_SIDED|95.0|5.0994|7.5329|||ANCOVA|||||7.5329|5.0994|<.0001
71752704|NCT00770653|143008106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8323||||0.4131|TWO_SIDED|95.0|-2.8312|1.1665|||ANCOVA|||||1.1665|-2.8312|0.4131
71752705|NCT00770653|143008107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8847|||<|0.0001|TWO_SIDED|95.0|-1.3067|-0.4627|||ANCOVA|||||-0.4627|-1.3067|<.0001
71669311|NCT02059512|142855679|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||HCT at the end of the operation.||||0.3
71669312|NCT02059512|142855680|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||K+ intraoperatively before turning off the cardiopulmonary bypass (CPB).||||0.4
71669313|NCT02059512|142855680|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||K+ at the end of the operation.||||0.1
71669314|NCT02059512|142855681|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71669315|NCT02059512|142855682|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71669316|NCT02059512|142855683|SUPERIORITY|||||||0.6|||||||Chi-squared|||Hydrothorax / postoperative period.||||0.6
71752706|NCT00770653|143008108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4903||||0.0929|TWO_SIDED|95.0|-5.3979|0.4172|||ANCOVA|||||0.4172|-5.3979|0.0929
71752707|NCT00770653|143008109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8832||||0.3279|TWO_SIDED|95.0|-2.6571|0.8906|||ANCOVA|||||0.8906|-2.6571|0.3279
71669317|NCT02059512|142855683|SUPERIORITY|||||||0.2|||||||Chi-squared|||Hydropericardium / postoperative period.||||0.2
71669318|NCT02059512|142855683|SUPERIORITY|||||||0.6|||||||Chi-squared|||Resternotomy / postoperative period.||||0.6
71752708|NCT00770653|143008110|SUPERIORITY_OR_OTHER||Fisher Exact|-3.33||||0.2895|TWO_SIDED|95.0|-14.83|8.39|||Fisher Exact|||The number and percentage of participants with a calculated compliance \>80% and \<120% are presented for both treatment groups. In addition, the p-values of Fisher's exact test, the two-sided 95% confidence intervals for the percentage of patients per treatment group and for the difference between the treatment groups are provided.||8.39|-14.83|0.2895
71669319|NCT02059512|142855683|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial fibrillation / postoperative period.||||0.06
71669320|NCT02059512|142855683|SUPERIORITY|||||||0.06|||||||Chi-squared|||Atrial flutter / postoperative period.||||0.06
71669321|NCT02059512|142855684|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||||||0.4
71669322|NCT02059512|142855685|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA kg / cm) - Evaluation of the left ventricular end-diastolic size index.||||0.5
71669323|NCT02059512|142855685|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - Evaluation of the left ventricular end-systolic size index.||||0.5
71669324|NCT02059512|142855685|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - Left Atrial Size Index Assessment.||||0.6
71669325|NCT02059512|142855686|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - Evaluation of the left ventricular end-diastolic volume index.||||0.4
71669326|NCT02059512|142855686|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||Evaluation of the left ventricular end-systolic volume index (LVESV MOD BP ind.)||||0.3
71669327|NCT02059512|142855687|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
71752709|NCT00770653|143008111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9516||||0.3517|TWO_SIDED|95.0|-94.1999|34.2967|||ANCOVA|||||34.2967|-94.1999|0.3517
71845408|NCT01478594|143205115|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.779|||||TWO_SIDED|95.0|0.397|1.531|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.531|0.397|
71669328|NCT02059512|142855689|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Physical Functioning SF-36. Comparison of patients of group 1 and group 2 with the control group - group 0.||||0.7
71669329|NCT02059512|142855689|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Role-Physical Functioning SF-36||||0.8
71669330|NCT02059512|142855689|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Bodily pain SF-36||||0.7
71669331|NCT02059512|142855689|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||General Health SF-36.||||0.6
71669332|NCT02059512|142855689|SUPERIORITY|||||||0.8|||||||RepeatedMeasures ANOVA|||Vitality SF-36.||||0.8
71669333|NCT02059512|142855689|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Social Functioning SF-36.||||0.7
71669334|NCT02059512|142855689|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Role- Emotional SF-36.||||0.7
71669335|NCT02059512|142855689|SUPERIORITY|||||||0.96|||||||RepeatedMeasures ANOVA|||Mental Health SF-36.||||0.96
71669336|NCT02059512|142855689|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Minnesota Quality of Life (MHFLQ).||||0.7
71669337|NCT02059512|142855689|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||Seattle QuestionnairePhysical limitation.||||0.6
71669338|NCT02059512|142855689|SUPERIORITY|||||||0.4|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina stability.||||0.4
71669339|NCT02059512|142855689|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireAngina frequency.||||0.6
71669340|NCT02059512|142855689|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaireTreatment satisfaction.||||0.7
71669341|NCT02059512|142855689|SUPERIORITY|||||||0.3|||||||RepeatedMeasures ANOVA|||SeattleQuestionnaire Disease perception.||||0.3
71669342|NCT02059512|142855690|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71669343|NCT02059512|142855691|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71669344|NCT02059512|142855692|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||||||0.35
71669345|NCT02059512|142855693|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvd ind. (Lvd mm./BSA) - left ventricular end-diastolic size index. All patients included in the study.||||0.2
71752710|NCT00770653|143008112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-151.4477||||0.1979|TWO_SIDED|95.0|-386.2256|83.3302|||ANCOVA|||||83.3302|-386.2256|0.1979
71752711|NCT00770653|143008113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.8589||||0.7186|TWO_SIDED|95.0|-163.3229|113.6052|||ANCOVA|||||113.6052|-163.3229|0.7186
71752712|NCT00770653|143008114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9728||||0.5058|TWO_SIDED|95.0|-39.9915|20.0459|||ANCOVA|||||20.0459|-39.9915|0.5058
71752713|NCT00770653|143008115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.3988||||0.523|TWO_SIDED|95.0|-60.7193|117.5169|||ANCOVA|||||117.5169|-60.7193|0.5230
71752714|NCT00770653|143008116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-367.2639||||0.2203|TWO_SIDED|95.0|-964.3923|229.8646|||ANCOVA|||||229.8646|-964.3923|0.2203
71752715|NCT00770653|143008117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0794||||0.585|TWO_SIDED|95.0|-95.6468|151.8057|||ANCOVA|||||151.8057|-95.6468|0.5850
71752716|NCT00770653|143008118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4205||||0.0138|TWO_SIDED|95.0|-4.3207|-0.5202|||ANCOVA|||||-0.5202|-4.3207|0.0138
71891837|NCT03193866|143305371|SUPERIORITY||Difference in proportion|0.7|||||TWO_SIDED|95.0|-7.5|8.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.8|-7.5|
71891838|NCT03193866|143305371|SUPERIORITY||Difference in proportion|-2.9|||||TWO_SIDED|95.0|-18.5|12.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.8|-18.5|
71896236|NCT00479466|143314600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|||<|0.001|TWO_SIDED|95.0|-1.91|-1.15|||ANCOVA|||||-1.15|-1.91|<0.001
71784559|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.73|TWO_SIDED|95.0|0.69|1.69||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.|The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.69|0.69|0.73
71784560|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.58|TWO_SIDED|95.0|0.58|2.6||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.|The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||2.60|0.58|0.58
71784561|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.65|TWO_SIDED|95.0|0.64|1.32||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.|The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.32|0.64|0.65
71784562|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.22|TWO_SIDED|95.0|0.45|1.2||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.|The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.20|0.45|0.22
71784563|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.53|TWO_SIDED|95.0|0.54|1.38||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.|The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.38|0.54|0.53
71784564|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.21|TWO_SIDED|95.0|0.53|1.15||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.|The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.15|0.53|0.21
71784565|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.19|TWO_SIDED|95.0|0.45|1.17||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.|The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.17|0.45|0.19
71784566|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|1.97||||0.16|TWO_SIDED|95.0|0.76|5.14||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.|The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||5.14|0.76|0.16
71784567|NCT01727297|143067895|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.63|TWO_SIDED|95.0|0.56|1.43||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.|The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).||1.43|0.56|0.63
71784568|NCT01192516|143067899|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, pain level, and body mass index at baseline.||||||.85
71784569|NCT01192516|143067902|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age, gender, and body mass index.||||||.06
71784570|NCT01192516|143067905|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED|||||Adjusted for age, gender, body mass index, and pain at baseline.|Mixed Models Analysis|||||||.36
71896237|NCT00479466|143314600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|||<|0.001|TWO_SIDED|95.0|-2.07|-1.31|||ANCOVA|||||-1.31|-2.07|<0.001
71669346|NCT02059512|142855693|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||Lvs ind. (Lvs mm./BSA kg / cm) - left ventricular end-systolic size index.||||0.2
71669347|NCT02059512|142855693|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||LAind. (LA mm./BSA kg / cm) - left atrial index.||||0.5
71752717|NCT00770653|143008119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0009||||0.0817|TWO_SIDED|95.0|-30.1139|1.8578|||ANCOVA|||||1.8578|-30.1139|0.0817
71752718|NCT00770653|143008120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9935||||0.1761|TWO_SIDED|95.0|-0.4843|2.4712|||ANCOVA|||||2.4712|-0.4843|0.1761
71752719|NCT00770653|143008121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5263||||0.0002|TWO_SIDED|95.0|1.3832|3.6695|||ANCOVA|||||3.6695|1.3832|0.0002
71752720|NCT00770653|143008122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2345||||0.0055|TWO_SIDED|95.0|1.0675|5.4016|||ANCOVA|||||5.4016|1.0675|0.0055
71752721|NCT00770653|143008123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9712||||0.0264|TWO_SIDED|95.0|0.3863|5.5562|||ANCOVA|||||5.5562|0.3863|0.0264
71752722|NCT00770653|143008124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5394||||0.0509|TWO_SIDED|95.0|-0.0114|5.0901|||ANCOVA|||||5.0901|-0.0114|0.0509
71752723|NCT00770653|143008125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1718||||0.1013|TWO_SIDED|95.0|-0.466|4.8097|||ANCOVA|||||4.8097|-0.4660|0.1013
71752724|NCT00770653|143008126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1346||||0.1363|TWO_SIDED|95.0|-0.7338|5.0031|||ANCOVA|||||5.0031|-0.7338|0.1363
71752725|NCT00770653|143008127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4181||||0.1165|TWO_SIDED|95.0|-0.6561|5.4922|||ANCOVA|||||5.4922|-0.6561|0.1165
71752726|NCT04906499|143008135|OTHER||Cohen's d effect size|0.13|||||TWO_SIDED|95.0|-0.68|0.93||||||||0.93|-0.68|
71784571|NCT03782792|143067913|OTHER||Risk Difference (RD)|0.487||||0.0004|TWO_SIDED|95.0|0.215|0.672||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the primary endpoint on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.672|0.215|0.0004
71845409|NCT01478594|143205116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.946|||||TWO_SIDED|95.0|0.636|5.956|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||5.956|0.636|
71752727|NCT04906499|143008137|OTHER||Cohen's d effect size|0.42|||||TWO_SIDED|95.0|-0.44|1.24||||||||1.24|-0.44|
71752728|NCT04906499|143008139|OTHER||Cohen's d effect size|0.85|||||TWO_SIDED|95.0|-0.13|1.77||||||||1.77|-0.13|
71752729|NCT04906499|143008141|OTHER||Cohen's d effect size|0.97|||||TWO_SIDED|95.0|-0.05|1.93||||||||1.93|-0.05|
71752730|NCT04906499|143008143|OTHER||Pearson's r Correlation Coefficient|0.32|||||TWO_SIDED|95.0|-0.67|0.9||||||||0.90|-0.67|
71752731|NCT04906499|143008144|OTHER||Pearson's r Correlation Coefficient|0.55|||||TWO_SIDED|95.0|-0.48|0.94||||||||0.94|-0.48|
71752732|NCT04906499|143008145|OTHER||Pearson's r Correlation Coefficient|0.23|||||TWO_SIDED|95.0|-0.88|0.71||||||||0.71|-0.88|
71752733|NCT04906499|143008146|OTHER||Pearson's r Correlation Coefficient|-0.19|||||TWO_SIDED|95.0|-0.87|0.73||||||||0.73|-0.87|
71752734|NCT04906499|143008148|OTHER||Cohen's d effect size|-0.42|||||TWO_SIDED|95.0|-1.24|0.44||||||||0.44|-1.24|
71752735|NCT00179621|143008151|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71752736|NCT00179621|143008151|SUPERIORITY_OR_OTHER||||||<|0.001||||||To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71752737|NCT00179621|143008152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71752738|NCT00179621|143008152|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus \>0) to compare lenalidomide treatment with placebo.||||||<0.001
71752739|NCT00179621|143008162|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71752740|NCT00179621|143008162|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71752741|NCT00179621|143008163|SUPERIORITY_OR_OTHER|||||||0.054||95.0|||||ANOVA|||||||0.054
71752742|NCT00179621|143008163|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.080
71752743|NCT00179621|143008164|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||ANOVA|||||||0.062
71752744|NCT00179621|143008164|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANOVA|||||||0.113
71752745|NCT02722564|143008167|OTHER||||||<|0.001||||||p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.|t-test, 2 sided|||||||<0.001
71752746|NCT02722564|143008167|OTHER||||||<|0.0001||||||p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.|t-test, 2 sided|||||||<0.0001
71752747|NCT01751061|143008180|SUPERIORITY|To test the primary hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|||||<|0.05||||||P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.|GEE|||We estimated that 210 patients (315 surrogates, assuming \~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.||||<0.05
71752748|NCT01751061|143008181|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||Generalized linear model.||||<0.05
71752749|NCT01751061|143008182|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear model|||||||<0.05
71752750|NCT01751061|143008183|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
71752751|NCT01751061|143008184|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
71669348|NCT02059512|142855694|SUPERIORITY|||||||0.6|||||||RepeatedMeasures ANOVA|||LVEDV MOD BP ind. (LVEDV MOD BP ml./BSA kg / cm) - left ventricular end-diastolic volume index.||||0.6
71752752|NCT01751061|143008185|SUPERIORITY||||||<|0.05||||||P values were calculated.|generalized linear models|||||||<0.05
71669349|NCT02059512|142855694|SUPERIORITY|||||||0.2|||||||RepeatedMeasures ANOVA|||LVESV MOD BP ind. (LVESV MOD BP ml./BSA kg / cm) - left ventricular end-systolic volume index.||||0.2
71669350|NCT02059512|142855695|SUPERIORITY|||||||0.35|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow||||0.35
71752753|NCT01751061|143008186|SUPERIORITY||||||<|0.05||||||P values were calculated.|GEE|||To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.||||<0.05
71752754|NCT01194830|143008189|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0005||95.0|-0.91|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.91|0.0005
71752755|NCT01194830|143008190|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.62|-0.22|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.22|-0.62|<0.0001
71784572|NCT03782792|143067914|OTHER||Risk Difference (RD)|0.317||||0.0118|TWO_SIDED|95.0|0.022|0.527||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.527|0.022|0.0118
71784573|NCT03782792|143067915|OTHER||Risk Difference (RD)|0.346||||0.0081|TWO_SIDED|95.0|0.058|0.554||One-sided P Value.|Suissa-Shuster Z-pooled test||Risk difference=Response rate of spesolimab - response rate of placebo.|The Suissa-Shuster Z-pooled test was implemented to test the treatment effect on the RS (estimand EN) at a 1-sided, alpha level of 0.025. Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.554|0.058|0.0081
71784574|NCT03782792|143067916|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
71669351|NCT02059512|142855695|SUPERIORITY|||||||0.7|||||||RepeatedMeasures ANOVA|||Peak A of transmitral flow.||||0.7
71669352|NCT02059512|142855696|SUPERIORITY|||||||0.5|||||||RepeatedMeasures ANOVA|||Peak E of transmitral flow/ Peak A of transmitral flow (E/A).||||0.5
71669353|NCT02059512|142855697|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||DT (Half-time of wave E).||||0.9
71752756|NCT01194830|143008191|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0002||95.0|-0.84|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.84|0.0002
71752757|NCT01194830|143008192|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003||95.0|-0.85|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs||||-0.26|-0.85|0.0003
71752758|NCT01194830|143008193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.063||||0.001|TWO_SIDED|95.0|1.764|9.358|||Regression, Logistic|||||9.358|1.764|0.0010
71752759|NCT01194830|143008194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.433||||0.0352|TWO_SIDED|95.0|1.124|26.26|||Regression, Logistic|||||26.260|1.124|0.0352
71752760|NCT01194830|143008195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.951||||0.0003|TWO_SIDED|95.0|1.651|5.274|||Regression, Logistic|||||5.274|1.651|0.0003
71752761|NCT01194830|143008196|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|7.2||0.0972||95.0|-26.1|2.2|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and number of other Oral Antidiabetic Drugs||||2.2|-26.1|0.0972
71752762|NCT01194830|143008197|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|24.45||0.9368||95.0|-53.8|49.86|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline 2-hour PPG, and number of other Oral Antidiabetic Drugs||||49.86|-53.80|0.9368
71752763|NCT00910104|143008261|SUPERIORITY||Hazard Ratio (HR)|8.6|||=|0.001|TWO_SIDED|95.0|2.0|37.3||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Crude (unadjusted) hazard ratios were estimated using proportional hazard regression. Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||37.3|2.0|=0.001
71784575|NCT03782792|143067917|OTHER|||||||0.0044||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0044
71813113|NCT03720938|143128562|SUPERIORITY|||||||55||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.||||000000055
71669354|NCT02059512|142855697|SUPERIORITY|||||||0.9|||||||RepeatedMeasures ANOVA|||time of isovolumic relaxation of the left ventricle||||0.9
71669355|NCT02059512|142855698|SUPERIORITY|||||||0.0367|||||||Kruskal-Wallis|||||||0.0367
71669356|NCT02059512|142855699|SUPERIORITY|||||||0.04|||||||Chi-squared|||Assessment of the functioning of grafts. Patency of grafts within a specified time of treatment (angiography).||||0.04
71669357|NCT02059512|142855700|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71669358|NCT02059512|142855701|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||||||0.05
71752764|NCT00910104|143008261|SUPERIORITY||Hazard Ratio (HR)|17.4||||0.001|TWO_SIDED|95.0|3.7|83.0||All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\<0.05 was established as an a priori threshold for statistical significance.|Regression, Cox|||The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \[DB\]\<=2 mg/dL). Adjusted hazard ratios were estimated using proportional hazard regression adjusted for baseline covariates (including duration of parenteral nutrition (PN) and baseline DB). Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).||83|3.7|0.001
71752765|NCT00910104|143008261|OTHER||||||<|0.0001|||||||Fisher Exact|||Comparison of proportion with reversal of cholestasis (direct bilirubin \<=2.0 mg/dL).||||<0.0001
71752766|NCT03547518|143008287|SUPERIORITY|||||||0.111|||||||t-test, 2 sided|||||||0.111
71752767|NCT03547518|143008288|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||||||0.487
71752768|NCT03547518|143008289|SUPERIORITY|||||||0.0393|||||||t-test, 2 sided|||||||0.0393
71784576|NCT03782792|143067918|OTHER|||||||0.0012||||||One-sided P Value.|Wilcoxon (Mann-Whitney)|||The effect of spesolimab was evaluated by a Wilcoxon rank test using the RS. Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 were assigned worst ranks for the testing. Missing data at Week 4 were imputed and handled via assessment of ranks.|The difference between treatments, based on the RS, using a modified Hodges-Lehmann (HL) estimate of the median difference and 95% Confidence Intervals could not be calculated due to lack of valid data.|||0.0012
71784577|NCT03782792|143067919|OTHER||Risk Difference (RD)|0.375|||||TWO_SIDED|95.0|0.058|0.581|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.581|0.058|
71784578|NCT03782792|143067920|OTHER||Risk Difference (RD)|0.403|||||TWO_SIDED|95.0|0.096|0.607|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.607|0.096|
71669359|NCT02059512|142855702|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||Mononuclear fraction %||||0.05
71752769|NCT03547518|143008290|SUPERIORITY|||||||0.242|||||||t-test, 2 sided|||||||0.242
71784579|NCT03782792|143067921|OTHER||Risk Difference (RD)|0.432|||||TWO_SIDED|95.0|0.096|0.636|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.636|0.096|
71784580|NCT03782792|143067923|OTHER||Risk Difference (RD)|0.151|||||TWO_SIDED|95.0|-0.138|0.401|||||Risk difference=Response rate of spesolimab - response rate of placebo.|Confidence intervals (95%) around the risk difference were produced using the Chan and Zhang method.||0.401|-0.138|
71836264|NCT03978871|143178208|SUPERIORITY|Data were collected using a Siemens Prisma MRI 3T scanner and preprocessed with fMRIprep. 12 ROI masks were generated from the CON network of a modified Schaefer atlas. First-level contrast estimates (negative \> neutral) for each voxel within each ROI were averaged with MarsBaR to produce 12 values for each person. These were subsequently averaged to produce a single value per person. A two-sample t-test was conducted in R to test for differences across intervention groups (mindset vs control).||||||0.43||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(145) = 0.80||||||0.43
71896238|NCT00479466|143314600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.45|-1.68|||ANCOVA|||||-1.68|-2.45|<0.001
71669360|NCT02059512|142855702|SUPERIORITY|||||||0.057|||||||Discriminant Analysis|Data were analyzed by 1, 2, and 3 sections according to the study design.||CD34+ %||||0.057
71669361|NCT02059512|142855702|SUPERIORITY|||||||0.05|||||||Discriminant Analysis|||CD133+ %||||0.05
71669362|NCT02059512|142855703|SUPERIORITY|||||||0.046|||||||Factor analysis|||Factor analysis - determining the influence of a factor, in this case, smoking, on the deficit in the number of meters passed according to the test with a 6-minute walk.||||0.046
71669363|NCT05017246|142855704|SUPERIORITY||Mean Difference (Final Values)|-44.9||||0.0249|TWO_SIDED|95.0|-84.0|-5.8|||Two-sample t-test|Unadjusted analysis|Intrathecal - Epidural|||-5.8|-84.0|0.0249
71752770|NCT03547518|143008291|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|||||||0.855
71752771|NCT01018030|143008292|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.386||||0.008|TWO_SIDED|95.0|-0.67|-0.1|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.10|-0.67|0.008
71752772|NCT01018030|143008292|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.357||||0.014|TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.|||-0.07|-0.64|0.014
71752773|NCT00189540|143008309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 3.||||0.35
71752774|NCT00189540|143008309|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||ANCOVA|||Comparison made is the difference from baseline at Month 6.||||0.17
71752775|NCT00189540|143008310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||95.0|||||Fisher Exact|||The comparison of groups at Month 3||||0.55
71752776|NCT00189540|143008310|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28||95.0|||||Fisher Exact|||The comparison of groups at Month 6.||||0.28
71752777|NCT00189540|143008311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||ANCOVA|||Comparison between groups at Month 3||||0.2
71752778|NCT00189540|143008311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0|||||ANCOVA|||Comparison between groups at Month 6||||0.04
71752779|NCT00189540|143008312|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.00
71752780|NCT00189540|143008313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||95.0|||||ANCOVA|||Comparison at Month 3||||0.77
71752781|NCT00189540|143008313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||95.0|||||ANCOVA|||Comparison at Month 6||||0.45
71836265|NCT03978871|143178209|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Timeseries were averaged to produce a single value representing each ROI's mean activity. Values for each ROI were then averaged to produce a single value per person representing mean network activity. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.29||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = -1.057||||||0.29
71836266|NCT03978871|143178210|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative reframe \> negative immerse) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.88||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(146) = 0.148||||||0.88
71836267|NCT03978871|143178211|SUPERIORITY|Data were preprocessed in fMRIprep. Separate right/left amygdala seeds were defined with the AAL1 atlas. Interaction regressors were created between seeds and task conditions. Average contrast estimates for interaction terms of relevant trials (negative \> neutral) were extracted with MarsBaR from 12 ROIs in the CON of a modified Schaefer atlas and the 24 values averaged. A two-sample t-test was conducted in R to compare average connectivity between groups (mindset vs control).||||||0.11||||||The threshold for statistical significance was p \< 0.05|t-test, 2 sided|t(145) = 1.631||||||.11
71836268|NCT03978871|143178212|SUPERIORITY|BOLD signals were spatially averaged within ROIs to produce a single time series for each ROI. Pearson correlations were calculated between each mean BOLD signal in the CON and each amygdala ROI to produce 24 connectivity values. These were averaged to produce a single value representing the strength of coupling of the CON network to the amygdala for each participant. These values were then submitted to a two-sample t-test to test for differences across intervention groups (mindset vs control).||||||0.92||||||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided|t(142) = 0.101||A two-sample t-test was conducted to compare average connectivity (between the amygdala and the CON network) during resting state between the mindset and control groups.||||0.92
71836269|NCT03978871|143178213|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||2.22e-05||||||Reported result for cluster localized in the Superior/Middle Temporal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000222
71836270|NCT03978871|143178213|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.17e-05||||||Reported result for cluster localized in the Middle Temporal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000117
71836271|NCT03978871|143178213|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||"Reported result for cluster localized in the Anterior Cingulate/Medial Frontal Gyrus.~FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels."|t-test, 2 sided|||||||.000000000
71669364|NCT05017246|142855705|SUPERIORITY||Risk Ratio (RR)|1.04||||0.94|TWO_SIDED|95.0|0.36|3.01|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||3.01|0.36|0.94
71836272|NCT03978871|143178213|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.86e-05||||||Reported result for cluster localized in the Middle Frontal Gyrus (Right). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000186
71836273|NCT03978871|143178213|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||0||||||Reported result for cluster localized in the Middle Frontal Gyrus (Left). FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.000000000
71836274|NCT03978871|143178213|SUPERIORITY|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative immerse \> neutral immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005. The WFU PickAtlas via xjview was used to determine anatomical localization for surviving clusters.||||||1.61e-05||||||Reported result for cluster localized in the Posterior Cingulate/Cingulate. FWE-corrected p-value is reported. pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 278 voxels.|t-test, 2 sided|||||||.0000161
71752782|NCT00189540|143008314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 3 versus baseline.||||0.06
71752783|NCT00189540|143008314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANCOVA|||Comparison between groups for mean TBI at Month 6 versus baseline.||||0.05
71669365|NCT05017246|142855706|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.59|TWO_SIDED|95.0|-1.01|0.48|||Bootstrap resampling method|Bootstrap resampling method based on raw data was applied for due to highly right-skewed data (5,000 Bootstrap samples were selected).|Intrathecal - Epidural|||0.48|-1.01|0.59
71752784|NCT01292486|143008340|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 2 days.|Median Difference (Final Values)|0.0|||<|0.025|TWO_SIDED|95.0|0.0|0.0|||Hodges-Lehman estimation|||The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.||0.0|0.0|<0.025
71752785|NCT04369404|143008347|SUPERIORITY|We hypothesize that participants who received the decision aid will have higher knowledge. This is pilot study, thus we did not have a power calculation.|Mean Difference (Final Values)|12.0||||0.06|TWO_SIDED|95.0|0.7|24.6|||t-test, 2 sided|||||24.6|0.7|0.06
71752786|NCT04369404|143008348|OTHER||Pearson Chi-Square|2.97||||0.085|TWO_SIDED||||||Chi-squared|||"a chisquare test was conducted to determine if the proportion of treatment unsure responses were different between the usual care and intervention arms."||||0.085
71752787|NCT04369404|143008349|OTHER||Pearson Chi-Square|1.524||||0.47|TWO_SIDED||||||Chi-squared|||||||0.47
71752788|NCT00265564|143008359|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||We investigated treatment condition differences in change of drug and alcohol use over four time-points using generalized linear mixed modeling analyses. A trajectory for each participant was modeled yielding estimates of baseline scores (intercept), slope, and error. Four between-person parameters were estimated: average baseline score for all participants, average slope over time in TAU condition, effect of being in SS on average intercept, effect of being in SS on average slope.||||> .05
71752789|NCT00265564|143008360|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71752790|NCT00265564|143008361|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Mixed Models Analysis|||Generalized linear mixed modeling analysis||||>.05
71784581|NCT03782792|143067924|OTHER||Median Difference (Final Values)|-16.88|||||TWO_SIDED|95.0|-67.32|12.76|||||Median difference was calculated by modified Hodges-Lehmann method.|Any assessments after death, the use of escape medication (before or after Day 8), open label spesolimab on Day 8, or rescue medication with spesolimab after Day 8 and assigned with the worst possible outcomes in rank analysis. Missing data at Week 4 were imputed and handled via assessment of ranks.||12.76|-67.32|
71845410|NCT01478594|143205116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.806|||||TWO_SIDED|95.0|0.422|1.538|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.538|0.422|
71669366|NCT05017246|142855707|SUPERIORITY||Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.61|1.48|||Chi-squared||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||1.48|0.61|0.82
71752791|NCT04739982|143008383|SUPERIORITY||Cohen's D|0.03|STANDARD_ERROR_OF_MEAN|1.36||0.41|TWO_SIDED|95.0|-0.21|0.27||An independent samples t-test was conducted to compare the change in baseline and follow-up scores of treatment and treatment as usual participants.|t-test, 1 sided|Degrees of freedom=274 Significance level=.05||||.27|-.21|.41
71752792|NCT04739982|143008384|SUPERIORITY||Cohen's D|0.153|STANDARD_ERROR_OF_MEAN|1.45||0.095|TWO_SIDED|95.0|-0.08|0.39|||t-test, 1 sided|||||.39|-.08|.095
71752793|NCT04739982|143008386|SUPERIORITY||Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.55||0.09|TWO_SIDED|95.0|-0.09|0.47|||t-test, 1 sided|||||.47|-.09|.09
71752794|NCT00988832|143008466|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71752795|NCT00988832|143008467|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANOVA|||||||0.0004
71752796|NCT00988832|143008468|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||ANOVA|||||||0.0041
71752797|NCT00988832|143008469|SUPERIORITY_OR_OTHER|||||||0.0423||95.0|||||ANOVA|||||||0.0423
71752798|NCT00988832|143008470|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANOVA|||||||0.0006
71752799|NCT00988832|143008471|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||ANOVA|||||||0.0014
71752800|NCT00988832|143008473|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71752801|NCT01283555|143008493|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||The p-value presented here represents a comparison of the total number of non-iatrogenic findings at baseline and after one week of product use.|Fisher Exact|||Fishers exact test was used to compare the frequency of non-iatrogenic colposcopic findings at baseline and follow-up visits (after one week of twice-daily product use).||||0.4870
71752802|NCT00537394|143008497|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.|Risk Difference (RD)|3.2|||||TWO_SIDED|95.0|-6.1|12.5|||||Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.|Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.||12.5|-6.1|
71752803|NCT04267380|143008512|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71752804|NCT04267380|143008513|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71752805|NCT04267380|143008514|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
71752806|NCT04267380|143008515|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
71752807|NCT04267380|143008516|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71752808|NCT04267380|143008517|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71752809|NCT04267380|143008518|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71752810|NCT04267380|143008519|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71752811|NCT04267380|143008521|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71752812|NCT04267380|143008522|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71752813|NCT04267380|143008523|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
71752814|NCT04267380|143008524|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||||||0.83
71752815|NCT04267380|143008525|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71752816|NCT04267380|143008526|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
71669367|NCT05017246|142855710|SUPERIORITY||Risk Ratio (RR)|1.56||||0.67|TWO_SIDED|95.0|0.27|8.95|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||8.95|0.27|0.67
71669368|NCT05017246|142855711|SUPERIORITY||Risk Ratio (RR)|2.08||||0.61|TWO_SIDED|95.0|0.19|22.2|||Fisher Exact||Estimated probability of having the event in Intrathecal group divided by that in Epidural group|||22.2|0.19|0.61
71669369|NCT02058069|142855715|NON_INFERIORITY_OR_EQUIVALENCE|The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.|Rare Adverse Event Rate|0.0|||||ONE_SIDED|95.0||0.0331|||||If the upper bound is \<0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.|||0.0331||
71669370|NCT02058069|142855717|OTHER|The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).|Alignment Difference <4.38 Degrees|1.0|||||ONE_SIDED|95.0|0.966||||||Estimation Parameter is: proportion of participants with limb alignment difference \<4.38 degrees If the lower bound is \>0.95 then the assessment passes.||||0.966|
71669371|NCT02058069|142855718|NON_INFERIORITY|The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.|Mean Difference (Final Values)|-33.1|||<|0.001|ONE_SIDED|95.0||-29.6|||t-test, 2 sided||If the upper bound is less than -9, then non-inferiority holds.|Change from pre-op to 3 months||-29.6||<0.001
71752817|NCT04267380|143008527|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
71752818|NCT04267380|143008528|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||||||0.99
71752819|NCT04267380|143008529|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71752820|NCT04267380|143008530|SUPERIORITY|||||||0.63|||||||Chi-squared|||||||0.63
71845411|NCT01478594|143205117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.776|||||TWO_SIDED|95.0|0.303|1.991|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.991|0.303|
71669372|NCT03290378|142855721|SUPERIORITY||||||<|0.005|TWO_SIDED|95.0|||||ANCOVA|||||||<.005
71669373|NCT01690117|142855722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|3.82|11.12||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||11.12|3.82|<0.001
71669374|NCT01690117|142855723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|STANDARD_ERROR_OF_MEAN|2.21|<|0.05|TWO_SIDED|95.0|1.0|9.86||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||9.86|1.00|<0.05
71669375|NCT01690117|142855724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.99|STANDARD_ERROR_OF_MEAN|1.0|<|0.01|TWO_SIDED|95.0|1.01|4.97||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.97|1.01|<0.01
71669376|NCT01690117|142855725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.87||0.06|TWO_SIDED|95.0|-0.05|3.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||3.45|-0.05|0.06
71669377|NCT01690117|142855726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.22||0.3|TWO_SIDED|95.0|-0.65|2.07||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.07|-0.65|0.30
71669378|NCT01690117|142855727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|1.02||0.24|TWO_SIDED|95.0|-0.66|2.59||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.59|-0.66|0.24
71669379|NCT01690117|142855728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|1.04|<|0.05|TWO_SIDED|95.0|-2.5|1.62||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||1.62|-2.50|<0.05
71752821|NCT04267380|143008531|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
71752822|NCT00534365|143008586|NON_INFERIORITY_OR_EQUIVALENCE|We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.||||||0.43|||||||Regression, Logistic|||||||0.43
71752823|NCT00534365|143008589|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
71752824|NCT00534365|143008590|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||||||0.015
71752825|NCT04886154|143008608|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.67|||||TWO_SIDED|97.5|3.38|5.97|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,6-months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.97|3.38|
71752826|NCT04886154|143008608|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY low dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|-0.17|||||TWO_SIDED|97.5|-1.65|1.3|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (low dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||1.30|-1.65|
71752827|NCT04886154|143008608|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_06 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|4.6|||||TWO_SIDED|97.5|3.33|5.89|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,6- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||5.89|3.33|
71752828|NCT04886154|143008608|SUPERIORITY|Superiority was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of samples with bactericidal serum activity is above 5% between the ABCWY high dose\_02 group compared to the Control group at 1 month after the last vaccination.|Difference in percentage|2.01|||||TWO_SIDED|97.5|0.6|3.42|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the superiority of the effectiveness of the MenABCWY-2Gen vaccine (high dose) when administered at 0,2- months schedule, compared to the MenB vaccine administered at 0,6-months schedule.||3.42|0.60|
71752829|NCT04886154|143008609|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.03|||||TWO_SIDED|97.5|-4.21|10.17|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.17|-4.21|
71752830|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|4.66|||||TWO_SIDED|97.5|-2.71|11.64|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||11.64|-2.71|
71752831|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|5.48|||||TWO_SIDED|97.5|-0.71|12.25|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||12.25|-0.71|
71752832|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|3.87|||||TWO_SIDED|97.5|-3.7|10.97|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men A).||10.97|-3.70|
71752833|NCT04886154|143008609|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|35.03|||||TWO_SIDED|97.5|25.22|44.75|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.75|25.22|
71669380|NCT01690117|142855729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|8.86||0.88|TWO_SIDED|95.0|-2.63|2.25||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||2.25|-2.63|0.88
71752834|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|34.16|||||TWO_SIDED|97.5|23.76|44.1|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||44.10|23.76|
71813114|NCT03720938|143128563|SUPERIORITY|||||||0||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.000
71813115|NCT03720938|143128563|SUPERIORITY|||||||1.633e-05||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by linear mixed-effects analysis.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.00001633
71784582|NCT02321800|143067961|NON_INFERIORITY|The margin of noninferiority was 20%. Noninferiority was concluded if the lower bound of a 2-sided 95% CI for the difference in response rates between the 2 treatment groups was greater than -20%. If the noninferiority inference based on the 20% margin was concluded successfully, noninferiority inference based on the 15% margin was performed.|Treatment Difference|18.58|||||TWO_SIDED|95.0|8.23|28.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||28.92|8.23|
71784583|NCT02321800|143067962|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-6.48|7.79||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.79|-6.48|
71784584|NCT02321800|143067963|OTHER||Treatment Difference|0.72|||||TWO_SIDED|95.0|-3.48|4.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||4.92|-3.48|
71784585|NCT02321800|143067964|OTHER||Treatment Difference|15.31|||||TWO_SIDED|95.0|4.69|25.92||||||||25.92|4.69|
71836275|NCT03978871|143178213|OTHER|Data were preprocessed in fMRIprep. A first-level contrast estimate of interest (negative reframe \> negative immerse) was submitted to a second-level t-test for group-level differences across experimental conditions (mindset \> control). Monte Carlo simulations using 3dClustSim in AFNI controlled cluster-level family-wise error rate at p \< 0.001 with a cluster-defining threshold of p \< 0.005.|||||>|0.001||||||pvoxel-level \< .005, pcluster-level \< .001. Cluster extent = 298 voxels.|t-test, 2 sided|||||||>.001
71836276|NCT03978871|143178214|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.56|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.560
71836277|NCT03978871|143178215|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.327|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on depression levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.327
71836278|NCT03978871|143178216|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.439|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect.||||0.439
71836279|NCT03978871|143178216|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.545|||||||ANCOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 2. This is a test of between by within-subjects interaction effect. Clarity of the psycho-educational lessons was included as a covariate.||||0.545
71669381|NCT01690117|142855730|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.93|STANDARD_ERROR_OF_MEAN|1.92|<|0.05|TWO_SIDED|95.0|-8.74|-1.11||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-1.11|-8.74|<0.05
71784586|NCT02321800|143067965|OTHER||Treatment Difference|17.25|||||TWO_SIDED|95.0|6.92|27.58||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||27.58|6.92|
71784587|NCT02321800|143067966|OTHER||Treatment Difference|1.28|||||TWO_SIDED|95.0|-4.83|7.39||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||7.39|-4.83|
71784588|NCT02321800|143067967|OTHER||Treatment Difference|1.1|||||TWO_SIDED|95.0|-3.04|5.25||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||5.25|-3.04|
71784589|NCT02321800|143067968|OTHER||Treatment Difference|13.92|||||TWO_SIDED|95.0|3.21|24.63||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||24.63|3.21|
71784590|NCT02321800|143067973|OTHER||Treatment Difference|2.39|||||TWO_SIDED|95.0|-4.66|9.44||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||9.44|-4.66|
71784591|NCT02321800|143067974|OTHER||Treatment Difference|-0.26|||||TWO_SIDED|95.0|-6.57|6.05||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||6.05|-6.57|
71836280|NCT03978871|143178217|SUPERIORITY|The threshold for statistical significance was p = 0.05.||||||0.74|||||||ANOVA|degrees of freedom = 1.||We are reporting the p-value for the group (Growth Mindset vs. Brain Education) by time effect (baseline and follow-up) on anxiety levels from time 1 to time 3. This is a test of between by within-subjects interaction effect.||||0.740
71669382|NCT01690117|142855731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-13.31|-3.66||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-3.66|-13.31|<0.001
71752835|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.88|||||TWO_SIDED|97.5|19.26|40.19|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||40.19|19.26|
71752836|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.54|||||TWO_SIDED|97.5|23.09|43.54|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men C).||43.54|23.09|
71752837|NCT04886154|143008609|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|30.88|||||TWO_SIDED|97.5|21.61|40.32|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||40.32|21.61|
71752838|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the MenABCWY-2Gen MenACWY vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.35|||||TWO_SIDED|97.5|19.31|39.08|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||39.08|19.31|
71752839|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.02|||||TWO_SIDED|97.5|19.42|38.67|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||38.67|19.42|
71752840|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|25.13|||||TWO_SIDED|97.5|14.2|35.45|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men W).||35.45|14.20|
71752841|NCT04886154|143008609|NON_INFERIORITY|Non-inferiority (NI) was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|33.38|||||TWO_SIDED|97.5|23.08|43.26|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||43.26|23.08|
71752842|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY low dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|28.18|||||TWO_SIDED|97.5|16.61|38.86|||||The 97.5% CIs for the difference in percentages between ABCWY low dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (low dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.86|16.61|
71752843|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_06 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|29.37|||||TWO_SIDED|97.5|18.67|39.63|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_06 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,6-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||39.63|18.67|
71669383|NCT01690117|142855732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.91|STANDARD_ERROR_OF_MEAN|1.98||0.05|TWO_SIDED|95.0|-7.86|0.04||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||0.04|-7.86|0.05
71784592|NCT02321800|143067975|OTHER||Treatment Difference|-1.07|||||TWO_SIDED|95.0|-3.42|1.29||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||1.29|-3.42|
71784593|NCT02321800|143067976|OTHER||Treatment Difference|9.02|||||TWO_SIDED|95.0|-0.37|18.41||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.||18.41|-0.37|
71784594|NCT00730132|143068027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Pearson Chi-Square|||Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.||||0.007
71784595|NCT00730132|143068028|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Chi square, continuity corrected. Asymptotic significance.|McNemar|||Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison||||<0.001
71784596|NCT00730132|143068029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.757|STANDARD_DEVIATION|12.30606||||95.0||||||||Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2||||
71784597|NCT00730132|143068029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|15.662||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
71784598|NCT00730132|143068029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.8181|STANDARD_DEVIATION|14.03545||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2||||
71784599|NCT00730132|143068029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.80928|STANDARD_ERROR_OF_MEAN|1.48621||0.143|TWO_SIDED|95.0|-6.307|0.6884|||Games-Howell|||Statin Dose Titration compared to New Statin||.6884|-6.3070|.143
71784600|NCT00730132|143068029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.74811|STANDARD_ERROR_OF_MEAN|1.56351||0.001|TWO_SIDED|95.0|-9.4298|-2.0664|||Games-Howell|||Statin Dose Titration compared to Ezetimbe||-2.0664|-9.4298|.001
71784601|NCT00730132|143068029|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.93883|STANDARD_ERROR_OF_MEAN|1.38286||0.086|TWO_SIDED|95.0|-6.1948|0.3171|||Games-Howell|||New Statin compared to Ezetimibe||.3171|-6.1948|.086
71784602|NCT00730132|143068030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.8174|STANDARD_DEVIATION|19.85205||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
71784603|NCT00730132|143068030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.2488|STANDARD_DEVIATION|20.78727||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
71784604|NCT00730132|143068030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.0665|STANDARD_DEVIATION|15.5901||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)||||
71784605|NCT00730132|143068030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.43138|STANDARD_ERROR_OF_MEAN|2.01009||0.756|TWO_SIDED|95.0|-6.1604|3.2977|||Games-Howell|||Statin Dose Titration compared to New Statin||3.2977|-6.1604|.756
71784606|NCT00730132|143068030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.24911|STANDARD_ERROR_OF_MEAN|1.97821||0.023|TWO_SIDED|95.0|-9.9072|-0.591|||Games-Howell|||Statin Dose Titration compared to Ezetimibe||-.5910|-9.9072|.023
71784607|NCT00730132|143068030|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.81773|STANDARD_ERROR_OF_MEAN|1.88425||0.107|TWO_SIDED|95.0|-8.2523|0.6169|||Games-Howell|||New Statin compared to Ezetimibe||.6169|-8.2523|.107
71784608|NCT01233258|143068055|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as only 1 primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.||||0.0001
71784609|NCT01233258|143068056|SUPERIORITY_OR_OTHER|||||||0.0001||||||No multiplicity adjustment as this is not primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
71784610|NCT01233258|143068057|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.||||0.0001
71784611|NCT01233258|143068058|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 10%|Median Difference (Net)|-0.0001||||0.0001|ONE_SIDED|95.0|-0.049|||No multiplicity adjustment as not primary endpoint.|Exact Permutation Test for paired sample||Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ|Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.|||-0.0490|0.0001
71784612|NCT00843024|143068067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.003|TWO_SIDED|95.0|0.09|0.3||Adjusted for multiplicity according to the fixed sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 10 mg/Naproxen 60 mg minus placebo|||0.30|0.09|0.003
71784613|NCT00843024|143068067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.003|TWO_SIDED|95.0|0.07|0.26||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 30 mg/Naproxen180 mg minus placebo|||0.26|0.07|0.003
71784614|NCT00843024|143068067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.003|TWO_SIDED|95.0|0.05|0.22||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 85 mg/Naproxen 500 mg minus placebo|||0.22|0.05|0.003
71784615|NCT00006237|143068111|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Log Rank|||||||0.49
71784616|NCT00006237|143068112|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||||||0.02
71784617|NCT02837783|143068137|SUPERIORITY|||||||0.283|||||||Wilcoxon rank sum test|||||||0.283
71752844|NCT04886154|143008609|NON_INFERIORITY|NI was to be demonstrated if the lower limit of the 2-sided 97.5% CI for the difference in percentages of participants achieving a 4-fold rise in hSBA titres is above -10% at 1 month after the last MenABCWY-2Gen vaccination in the ABCWY high dose\_02 group compared to the MenACWY vaccination in the Control group.|Difference in percentage|27.21|||||TWO_SIDED|97.5|15.46|38.02|||||The 97.5% CIs for the difference in percentages between ABCWY high dose\_02 group and the control group is constructed using the method of Miettinen and Nurminen.|To demonstrate the immunological non-inferiority of the MenABCWY-2Gen vaccine (high dose) administered at 0,2-months schedule compared to the MenACWY vaccine administered at month 0 in the control group (Men Y).||38.02|15.46|
71752845|NCT02099864|143008646|OTHER||Odds Ratio (OR)|10.0||||0.055|TWO_SIDED|95.0|0.9|108.8|||Fisher Exact|Due to sample size, Fisher's exact test was used rather than simple logistic regression.||||108.8|0.9|0.055
71752846|NCT02099864|143008647|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.1|5.3|||Fisher Exact|Due to sample size, Fisher's exact was used rather than regression.||||5.3|0.1|1.000
71752847|NCT02099864|143008648|OTHER||Odds Ratio (OR)|0.7||||1|TWO_SIDED|95.0|0.0|17.0|||Fisher Exact|||||17.0|0.0|1.000
71752848|NCT02099864|143008649|OTHER||Median Difference (Final Values)|23.2||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.84
71784618|NCT02216591|143068147|SUPERIORITY|||||||0.013|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.||||||.013
71669384|NCT01690117|142855733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.1||0.91|TWO_SIDED|95.0|-3.96|4.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||4.45|-3.96|0.91
71752849|NCT02099864|143008650|OTHER||Median Difference (Final Values)|-1.9||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for responders minus the median for non-responders.|||||0.14
71752850|NCT02099864|143008651|OTHER||Odds Ratio (OR)|2.7||||1|TWO_SIDED|95.0|0.1|60.2|||Fisher Exact|||||60.2|0.1|1.00
71752851|NCT02099864|143008653|OTHER||Median Difference (Final Values)|4.8||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Difference is the median for the responders minus the median for the non-responders.|||||0.01
71752852|NCT02099864|143008656|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
71752853|NCT02099864|143008657|OTHER||Hazard Ratio (HR)|0.22||||0.002|TWO_SIDED|95.0|0.08|0.56|||Regression, Cox|||||0.56|0.08|0.002
71752854|NCT02099864|143008658|OTHER||Hazard Ratio (HR)|0.23||||0.23|TWO_SIDED|95.0|0.02|0.59|||Regression, Cox|||||0.59|0.02|0.23
71752855|NCT02099864|143008659|OTHER||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.07|0.45|||Regression, Cox|||||0.45|0.07|<0.001
71784619|NCT02216591|143068148|SUPERIORITY|||||||0.274|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274||||||.274
71669385|NCT01690117|142855734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.47||0.05|TWO_SIDED|95.0|-0.01|5.81||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||5.81|-0.01|0.05
71669386|NCT01690117|142855735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|1.91|<|0.05|TWO_SIDED|95.0|0.68|8.33||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||8.33|0.68|<0.05
71669387|NCT01690117|142855736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53|STANDARD_ERROR_OF_MEAN|1.95|<|0.01|TWO_SIDED|95.0|-8.4|-0.65||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||-0.65|-8.40|<0.01
71669388|NCT01690117|142855737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.01|TWO_SIDED|95.0|4.78|10.83||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||||10.83|4.78|<0.01
71752856|NCT02099864|143008664|OTHER||Hazard Ratio (HR)|4.9|||<|0.001|TWO_SIDED|95.0|2.03|11.82|||Regression, Cox|||||11.82|2.03|<0.001
71752857|NCT01841281|143008714|OTHER|||||||0.78||||||The p-value is for the interaction term|testing for interaction term|||||||0.78
71752858|NCT01841281|143008715|OTHER|||||||0.09||||||The p-value is for the interaction term|testing for interaction term|||The treatment effect was tested as an interaction term between treatment and FeNO. The null hypothesis is the effect of treatment is stratified by the FeNO status. We used a regression model instead of t-test or Wilcoxon signed-rank test in order to control period and carry-over effect which is common in a cross-over study design||||0.09
71669389|NCT01288807|142855749|OTHER|repeated measure ANOVA|||||<|0.01|||||||ANOVA|||||||< 0.01
71669390|NCT01288807|142855750|OTHER|two-tailed paired t-test|||||<|0.05|||||||t-test, 2 sided|||This analysis looks at the cold threshold measured in degrees celcius before and after treatment.||||< 0.05
71669391|NCT01288807|142855751|OTHER||||||>|0.05|||||||t-test, 2 sided|||This analysis looks at the pressure threshold measured in pounds per square inch before and after treatment||||> 0.05
71669392|NCT01288807|142855752|OTHER||||||>|0.05||||||one-way repeated measure ANOVA|ANOVA|||||||> 0.05
71669393|NCT01113892|142855778|NON_INFERIORITY|"The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products."|Mean Difference (Net)|16.4|||<|0.0001|TWO_SIDED|95.0|2.7|29.9||The threshold for significance was p = .05|Exact 1-sided test||Difference = Patency (Fusion Bioline) - Patency (EXXCEL)|It was calculated that 200 participants randomized in a 1:1 fashion would have at least 80% power to detect a difference of 15% in the number of participants with primary patency between FUSION Bioline and EXXCEL groups at 6 months. It was assumed that the ratio of Above-Knee to Below-Knee procedures was 60:40; based on this, the primary patency rate for the combined Above-Knee and Below-Knee patients was 79%. Assumptions included a 10% withdrawal rate prior to the 6-month evaluation.||29.9|2.7|<.0001
71752859|NCT02891174|143008716|EQUIVALENCE|margin=10 mmHg|Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-3.7|5.7|||||The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.|||5.7|-3.7|
71784620|NCT02216591|143068149|SUPERIORITY|||||||0.41|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410||||||.410
71896239|NCT00479466|143314600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.7|-0.95|||ANCOVA|||||-0.95|-1.70|<0.001
71669394|NCT01113892|142855779|EQUIVALENCE|Fisher's Exact test was used to evaluate whether subjects with any MALE event or POD were homogeneous across the treatment arms.||||||0.033|ONE_SIDED|95.0|||||Fisher Exact|||The number and percentage of subjects with a MALE or POD event were summarized by treatment group.||||.033
71669395|NCT01113892|142855780|OTHER|||||||0.017|||||||Chi-squared|Proportion of subjects who achieved primary assisted patency for both treatment groups were compared using a Chi-Square test||||||.017
71669396|NCT01113892|142855781|OTHER|||||||0.137|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi-Square test||||||.137
71669397|NCT01113892|142855782|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Difference between groups were compared with the Wilcoxon Rank Sum Test||||<.0001
71752860|NCT02891174|143008717|SUPERIORITY|||||||0.59||||||Abdominal pain|t-test, 2 sided|||Change in abdominal pain||||0.59
71752861|NCT02891174|143008717|SUPERIORITY|||||||0.91||||||Perineal pain|t-test, 2 sided|||Change in perineal pain||||0.91
71752862|NCT02891174|143008717|SUPERIORITY|||||||0.88||||||Overall pain|t-test, 2 sided|||Change in overall pain||||0.88
71752863|NCT02891174|143008718|OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
71752864|NCT02891174|143008719|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||First intervention (24 hours)||||0.02
71752865|NCT02891174|143008719|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Second intervention (24 hours)||||0.06
71752866|NCT02891174|143008719|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Overall satisfaction with pain control during study period||||0.04
71784621|NCT02207244|143068150|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
71784622|NCT02207244|143068151|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
71784623|NCT02207244|143068152|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
71784624|NCT02207244|143068153|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
71784625|NCT02207244|143068154|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||< 0.001
71784626|NCT02207244|143068155|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|||p value is based on the log-rank test stratified by investigator site (pooled).||||< 0.001
71752867|NCT04516746|143008736|SUPERIORITY||Vaccine efficacy|73.98|||<|0.001|TWO_SIDED|95.0|65.34|80.47|||Poisson regression with robust variance|||The 95% confidence interval (CI) and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.47|65.34|<0.001
71752868|NCT04516746|143008740|SUPERIORITY||Vaccine efficacy|64.32|||<|0.001|TWO_SIDED|95.0|56.05|71.03|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||71.03|56.05|<0.001
71677143|NCT02821338|142872692|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference ratio|0.9863|||||TWO_SIDED|90.0|0.9598|1.0134||||||90% confidence interval of the geometric mean ratio of test/reference||1.0134|0.9598|
71752869|NCT04516746|143008741|SUPERIORITY||Vaccine efficacy|69.65|||<|0.001|TWO_SIDED|95.0|60.68|76.57|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||76.57|60.68|<0.001
71752870|NCT04516746|143008742|SUPERIORITY||Vaccine efficacy|70.7|||<|0.001|TWO_SIDED|95.0|61.62|77.64|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||77.64|61.62|<0.001
71752871|NCT04516746|143008743|SUPERIORITY||Vaccine efficacy|73.68|||<|0.001|TWO_SIDED|95.0|65.13|80.13|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||80.13|65.13|<0.001
71752872|NCT04516746|143008744|SUPERIORITY||Vaccine efficacy|100.0|||<|0.001|ONE_SIDED|97.5|71.62||||Poisson regression exact conditional|||The exact 1-sided 97.5% CI and p-value were estimated based on stratified Poisson regression with exact conditional method (including study arm and stratification factor \[age group at informed consent\] as strata factor and log of total number of participants for each combination of study arm and strata as an offset).|||71.62|<0.001
71752873|NCT04516746|143008745|SUPERIORITY||Vaccine efficacy|84.97|||<|0.001|TWO_SIDED|95.0|58.97|94.5|||Poisson regression with robust variance|||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||94.50|58.97|<0.001
71752874|NCT04516746|143008746|SUPERIORITY||Vaccine efficacy|94.8||||0.005|TWO_SIDED|95.0|58.98|99.34|||Poisson regression with robust variance|||The 95% CI and p-value were estimated based on Poisson regression with robust variance (including study arm and stratification factor \[age group at informed consent\] as covariates, and log of the follow up time as an offset).||99.34|58.98|0.005
71752875|NCT04516746|143008753|SUPERIORITY||Vaccine efficacy|54.47|||||TWO_SIDED|95.0|46.48|61.26||||||The 95% CI were estimated based on Poisson regression with robust variance (including study arm and age group at screening (18-65 years, ≥ 65 years) as covariates and log of the follow-up time as an offset).||61.26|46.48|
71752876|NCT04231669|143008778|SUPERIORITY|||||||0.05|||||||Linear Mixed-effects regression|||||||0.05
71784627|NCT02207244|143068156|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
71752877|NCT05543265|143008793|SUPERIORITY||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|6.4|28.8|||Chi-squared|||||28.8|6.4|<0.001
71784628|NCT02207244|143068157|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|16.4|||<|0.001|TWO_SIDED|95.0|10.0|23.2|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||23.2|10.0|< 0.001
71677144|NCT02821338|142872693|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|0.9785|||||TWO_SIDED|90.0|0.9484|1.0095||||||||1.0095|0.9484|
71752878|NCT05316597|143008821|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.914|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.914
71752879|NCT05316597|143008822|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.554|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||.554
71752880|NCT05316597|143008823|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.905|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|||||||0.905
71752881|NCT05316597|143008824|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.076|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.076
71752882|NCT05316597|143008824|SUPERIORITY|||||||0.02||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.02
71752883|NCT05316597|143008825|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.21|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.210
71752884|NCT05316597|143008825|SUPERIORITY|||||||0.57||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||Exploratory ANOVA results comparing full and reduced models to test the effect of terpene exposure on pattern of outcome over time.||||0.57
71784629|NCT02207244|143068157|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71784630|NCT02207244|143068158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10.0%|Difference in Percentage|23.3|||<|0.001|TWO_SIDED|95.0|16.0|30.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||30.4|16.0|< 0.001
71784631|NCT02207244|143068158|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71784632|NCT02207244|143068159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -10%|Difference in percentage|17.7|||<|0.001|TWO_SIDED|95.0|11.4|24.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||24.4|11.4|< 0.001
71784633|NCT02207244|143068159|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71784634|NCT02207244|143068160|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71784635|NCT02207244|143068161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
71784636|NCT02207244|143068162|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71784637|NCT00279305|143068190|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.104||0.05|TWO_SIDED|95.0|-0.0699|0.348|||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||0.348|-0.0699|0.05
71784638|NCT03919799|143068207|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|1.06||||0.9472|TWO_SIDED|95.0|0.19|5.82||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg QD versus Placebo||5.82|0.19|0.9472
71784639|NCT03919799|143068207|SUPERIORITY|The LOCF imputation was followed by logistic regression analysis. Comparison analysis between belumosudil dose regimen and placebo was performed using a logistic regression analysis with treatment in the model.|Odds Ratio (OR)|0.39||||0.3078|TWO_SIDED|95.0|0.07|2.35||Threshold for significance at 0.05 level.|Regression, Logistic|||Belumosudil 200 mg BID versus Placebo||2.35|0.07|0.3078
71677145|NCT02821338|142872694|EQUIVALENCE|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|1.047|||||TWO_SIDED|90.0|1.0079|1.0877||||||||1.0877|1.0079|
71784640|NCT03919799|143068208|SUPERIORITY|MMRM analysis used rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-0.04||||0.9889|TWO_SIDED|95.0|-6.51|6.42||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||6.42|-6.51|0.9889
71784641|NCT03919799|143068208|SUPERIORITY|MMRM analysis using rank-transformed data, with CRISS score as a dependent variable and treatment, visit, and visit x treatment interaction as fixed effects. Visit was a repeated factor, and analyses were done through week 24.|Least square mean difference|-4.18||||0.1916|TWO_SIDED|95.0|-10.59|2.23||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||2.23|-10.59|0.1916
71784642|NCT03919799|143068210|SUPERIORITY||Least square mean difference|-0.6||||0.771|TWO_SIDED|95.0|-4.7|3.6||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||3.6|-4.7|0.7710
71677146|NCT00712881|142872740|OTHER|||||||0.154||||||Threshold for significance at 0.05 level.|2-sided, binomial proportions|||||||0.154
71784643|NCT03919799|143068210|SUPERIORITY||Least square mean difference|4.6||||0.0308|TWO_SIDED|95.0|0.5|8.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||8.8|0.5|0.0308
71784644|NCT03919799|143068211|SUPERIORITY||Least square mean difference|1.4||||0.6533|TWO_SIDED|95.0|-4.9|7.7||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||7.7|-4.9|0.6533
71784645|NCT03919799|143068211|SUPERIORITY||Least square mean difference|-1.5||||0.6338|TWO_SIDED|95.0|-8.1|5.0||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||5.0|-8.1|0.6338
71784646|NCT03919799|143068212|SUPERIORITY||Least square mean difference|14.6||||0.0916|TWO_SIDED|95.0|-2.5|31.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||31.8|-2.5|0.0916
71784647|NCT03919799|143068212|SUPERIORITY||Least square mean difference|-8.6||||0.3146|TWO_SIDED|95.0|-25.7|8.6|||MMRM|||Belumosudil 200 mg BID versus Placebo||8.6|-25.7|0.3146
71784648|NCT03919799|143068213|SUPERIORITY||Least square mean difference|-10.0||||0.3753|TWO_SIDED|95.0|-32.8|12.8||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||12.8|-32.8|0.3753
71784649|NCT03919799|143068213|SUPERIORITY||Least square mean difference|-0.7||||0.9481|TWO_SIDED|95.0|-23.5|22.1||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||22.1|-23.5|0.9481
71784650|NCT03919799|143068214|SUPERIORITY||Least square mean difference|-0.036||||0.8387|TWO_SIDED|95.0|-0.392|0.32||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||0.320|-0.392|0.8387
71784651|NCT03919799|143068214|SUPERIORITY||Least square mean difference|0.039||||0.8234|TWO_SIDED|95.0|-0.317|0.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||0.395|-0.317|0.8234
71784652|NCT03919799|143068215|SUPERIORITY||Least square mean difference|-3.009||||0.7535|TWO_SIDED|95.0|-22.413|16.395||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||16.395|-22.413|0.7535
71784653|NCT03919799|143068215|SUPERIORITY||Least square mean difference|-21.015||||0.0348|TWO_SIDED|95.0|-40.419|-1.611||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||-1.611|-40.419|0.0348
71784654|NCT03919799|143068216|SUPERIORITY||Least square mean difference|45.566||||0.0343|TWO_SIDED|95.0|3.621|87.512||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||87.512|3.621|0.0343
71784655|NCT03919799|143068216|SUPERIORITY||Least square mean difference|-21.984||||0.2922|TWO_SIDED|95.0|-63.93|19.962||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||19.962|-63.930|0.2922
71784656|NCT03919799|143068217|SUPERIORITY||Least square mean difference|-16.757||||0.532|TWO_SIDED|95.0|-70.933|37.419||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||37.419|-70.933|0.5320
71784657|NCT03919799|143068217|SUPERIORITY||Least square mean difference|4.02||||0.8804|TWO_SIDED|95.0|-50.156|58.196||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg BID versus Placebo||58.196|-50.156|0.8804
71752885|NCT05316597|143008826|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.921|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.921
71752886|NCT05316597|143008826|SUPERIORITY|||||||0.82||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.82
71752887|NCT05316597|143008827|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.265|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.265
71752888|NCT05316597|143008827|SUPERIORITY|||||||0.63||||||Threshold of P \< 0.05 for significance. ANCOVA results of comparing reduced vs. full model over time.|ANOVA|||||||0.63
71752889|NCT05316597|143008828|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.724|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.724
71752890|NCT05316597|143008829|SUPERIORITY||Mean Difference (Final Values)|-2.85||||0.716|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.716
71752891|NCT05316597|143008830|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.852|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.852
71752892|NCT05316597|143008831|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.166|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.166
71752893|NCT05316597|143008832|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.046|TWO_SIDED|||||a priori threshold for statistical significance = p \< 0.05.|Mixed Models Analysis|Control for that session's baseline included in the mixed model.||||||0.046
71752894|NCT05526716|143008849|NON_INFERIORITY|Serotype 3|Geometric Mean Titers Ratio (GMT Ratio)|0.84|||||TWO_SIDED|95.0|0.72|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.97|0.72|
71784658|NCT03919799|143068218|SUPERIORITY||Least square mean difference|7.522||||0.8628|TWO_SIDED|95.0|-80.837|95.88||Threshold for significance at 0.05 level.|MMRM|||Belumosudil 200 mg QD versus Placebo||95.880|-80.837|0.8628
71752895|NCT05526716|143008849|NON_INFERIORITY|Serotype 6A|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.66|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.66|
71752896|NCT05526716|143008849|NON_INFERIORITY|Serotype 7F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.63|
71896240|NCT00479466|143314601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-56.8|||<|0.001|TWO_SIDED|95.0|-79.4|-34.3|||ANCOVA|||||-34.3|-79.4|<0.001
71752897|NCT05526716|143008849|NON_INFERIORITY|Serotype 8|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.61|0.82||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.82|0.61|
71752898|NCT05526716|143008849|NON_INFERIORITY|Serotype 9N|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.57|0.79||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.79|0.57|
71752899|NCT05526716|143008849|NON_INFERIORITY|Serotype 10A|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
71752900|NCT05526716|143008849|NON_INFERIORITY|Serotype 11A|GMT Ratio|0.64|||||TWO_SIDED|95.0|0.54|0.75||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.75|0.54|
71752901|NCT05526716|143008849|NON_INFERIORITY|Serotype 12F|GMT Ratio|0.76|||||TWO_SIDED|95.0|0.62|0.94||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.94|0.62|
71752902|NCT05526716|143008849|NON_INFERIORITY|Serotype 15A|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.6|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.60|
71752903|NCT05526716|143008849|NON_INFERIORITY|Serotype 15C|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.58|
71752904|NCT05526716|143008849|NON_INFERIORITY|Serotype 16F|GMT Ratio|0.69|||||TWO_SIDED|95.0|0.59|0.81||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.81|0.59|
71752905|NCT05526716|143008849|NON_INFERIORITY|Serotype 17F|GMT Ratio|0.73|||||TWO_SIDED|95.0|0.62|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.62|
71752906|NCT05526716|143008849|NON_INFERIORITY|Serotype 19A|GMT Ratio|0.75|||||TWO_SIDED|95.0|0.65|0.85||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.85|0.65|
71752907|NCT05526716|143008849|NON_INFERIORITY|Serotype 20A|GMT Ratio|0.74|||||TWO_SIDED|95.0|0.63|0.87||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.87|0.63|
71784659|NCT03919799|143068218|SUPERIORITY||Least square mean difference|-42.442||||0.3196|TWO_SIDED|95.0|-128.242|43.359|||MMRM|||Belumosudil 200 mg BID versus Placebo||43.359|-128.242|0.3196
71784660|NCT01411774|143068341|SUPERIORITY|||||||0.95||||||p \< .05 was the threshold of significance.|Mixed Models Analysis|Analysis for the outcomes used linear mixed-effects models, with treatment group as the between-participant factor and time as the within group factor||||||.95
71669398|NCT01113892|142855784|NON_INFERIORITY|"Repeated 6 month analyses for 12 month results.The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate for FUSION Bioline (PF), and the primary patency rate for EXXCEL (PE).~H0: PF - PE \< - 0.15; HA: PF - PE \> - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products, with a p-value ≤ .05 indicating significance."|Mean Difference (Net)|9.5||||0.0001|TWO_SIDED|95.0|-4.8|23.0|||Exact 1-sided test|||||23.0|-4.8|.0001
71669399|NCT01113892|142855786|OTHER|||||||0.181|||||||Chi-squared|Proportion of subjects who achieve primary assisted patency for both treatment groups will be compared using a Chi-Square test||||||.181
71669400|NCT01113892|142855788|OTHER|||||||0.68|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi Square test||||||.68
71669401|NCT02200055|142855795|SUPERIORITY_OR_OTHER|This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.|Mean Difference (Final Values)|0.53|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71669402|NCT01015534|142855818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.9||||0.019|TWO_SIDED|95.0|1.3|12.9||The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29|Chi-squared|||||12.9|1.3|0.019
71752908|NCT05526716|143008849|NON_INFERIORITY|Serotype 22F|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.91|0.65|
71752909|NCT05526716|143008849|NON_INFERIORITY|Serotype 23A|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.63|0.96||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.96|0.63|
71752910|NCT05526716|143008849|NON_INFERIORITY|Serotype 23B|GMT Ratio|0.56|||||TWO_SIDED|95.0|0.44|0.72||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.72|0.44|
71752911|NCT05526716|143008849|NON_INFERIORITY|Serotype 24F|GMT Ratio|0.72|||||TWO_SIDED|95.0|0.61|0.86||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.86|0.61|
71752912|NCT05526716|143008849|NON_INFERIORITY|Serotype 31|GMT Ratio|0.68|||||TWO_SIDED|95.0|0.56|0.83||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||0.83|0.56|
71752913|NCT05526716|143008849|NON_INFERIORITY|Serotype 33F|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of the serotypes is \>0.50.||1.01|0.70|
71784661|NCT00056316|143068344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
71784662|NCT00056316|143068345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.07||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control|||||.05
71784663|NCT04617509|143068350|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric means|1.4514|||||TWO_SIDED|90.0|1.111|1.4514||||||Relative bioavailability (A versus B)||1.4514|1.1110|
71669403|NCT01015534|142855819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.704|TWO_SIDED|95.0|0.138|3.422|||Fisher Exact|||||3.422|.138|.704
71669404|NCT01015534|142855820|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Log Rank|||||||0.84
71669405|NCT00793455|142855824|SUPERIORITY_OR_OTHER||Rate Ratio|3.1|||<|0.05|TWO_SIDED|95.0|1.5|6.2|||Chi-squared|||We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value \< .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.||6.2|1.5|<0.05
71752914|NCT05526716|143008849|NON_INFERIORITY|Serotype 35B|GMT Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the OPA GMT ratio (GMTcon/GMTseq) for each of serotypes is \>0.50.||0.89|0.67|
71752915|NCT05526716|143008850|NON_INFERIORITY|A/H1N1|GMT Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.97|0.70|
71752916|NCT05526716|143008850|NON_INFERIORITY|A/H3N2|GMT Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.93||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.93|0.67|
71752917|NCT05526716|143008850|NON_INFERIORITY|B/Victoria|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||0.95|0.70|
71784664|NCT04617509|143068350|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on Cmax ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.5497|||||TWO_SIDED|90.0|0.3977|0.7597||||||Relative bioavailability (A FED versus A FASTED)||0.7597|0.3977|
71784665|NCT04617509|143068351|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.3441|||||TWO_SIDED|90.0|1.0953|1.6495||||||Relative bioavailability (A versus B)||1.6495|1.0953|
71784666|NCT04617509|143068351|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-inf ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7327|||||TWO_SIDED|90.0|0.591|0.9083||||||Relative bioavailability (A FED versus A FASTED)||0.9083|0.5910|
71669406|NCT00793455|142855825|SUPERIORITY_OR_OTHER||Rate Ratio|1.5|||<|0.05|TWO_SIDED|95.0|1.03|2.2|||Chi-squared|||Same as primary outcome.||2.2|1.03|<0.05
71669407|NCT04782076|142855827|OTHER||LS Mean Difference (Final Values)|1.43|||||TWO_SIDED|90.0|1.33|1.55|||Mixed Models Analysis|Least Squares Mean (LS Mean)||||1.55|1.33|
71752918|NCT05526716|143008850|NON_INFERIORITY|B/Yamagata|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.0||||||The concomitant group will be considered noninferior to the sequential group if the lower bound of the 2-sided 95% CI of the HAI GMT ratio (GMTcon/GMTseq) for each of the strains is \>0.67.||1.00|0.78|
71752919|NCT05526716|143008851|OTHER|Serotype 3|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.8|1.02||||||||1.02|0.80|
71752920|NCT05526716|143008851|OTHER|Serotype 6A|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.79|1.11||||||||1.11|0.79|
71752921|NCT05526716|143008851|OTHER|Serotype 7F|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.67|0.9||||||||0.90|0.67|
71752922|NCT05526716|143008851|OTHER|Serotype 8|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.95||||||||0.95|0.70|
71784667|NCT04617509|143068352|SUPERIORITY|Relative bioavailability for Formulation A (FASTED) versus Formulation B (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|1.371|||||TWO_SIDED|90.0|1.112|1.6904||||||Relative bioavailability (A versus B)||1.6904|1.1120|
71784668|NCT04617509|143068352|SUPERIORITY|Relative bioavailability for Formulation A (FED) versus Formulation A (FASTED). The calculated relative bioavailability is based on AUC0-24h ratio (ratio of geometric means) and is presented with 90% CI.|Ratio of geometric mean|0.7083|||||TWO_SIDED|90.0|0.5728|0.8759||||||Relative bioavailability (A FED versus A FASTED)||0.8759|0.5728|
71784669|NCT00903695|143068363|SUPERIORITY_OR_OTHER|||||||0.8133||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio = 0.06, t-test = -0.25."||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.8133
71784670|NCT00903695|143068364|SUPERIORITY_OR_OTHER|||||||0.31||||||a priori threshold for statistical sginficance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio=1.22, t-test=1.1"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.31
71784671|NCT00903695|143068365|SUPERIORITY_OR_OTHER|||||||0.27||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.5, t-test = -1.23"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.27
71896241|NCT00479466|143314601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||<|0.001|TWO_SIDED|95.0|-91.8|-48.2|||ANCOVA|||||-48.2|-91.8|<0.001
71669408|NCT04782076|142855828|OTHER||LS Mean Difference (Final Values)|1.38|||||TWO_SIDED|90.0|1.3|1.46|||Mixed Models Analysis|||||1.46|1.30|
71669409|NCT04910100|142855832|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|6.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71752923|NCT05526716|143008851|OTHER|Serotype 9N|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.05||||||||1.05|0.75|
71752924|NCT05526716|143008851|OTHER|Serotype 10A|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.94||||||||0.94|0.67|
71752925|NCT05526716|143008851|OTHER|Serotype 11A|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.96||||||||0.96|0.72|
71752926|NCT05526716|143008851|OTHER|Serotype 12F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.01||||||||1.01|0.69|
71752927|NCT05526716|143008851|OTHER|Serotype 15A|GMC Ratio|0.75|||||TWO_SIDED|95.0|0.63|0.9||||||||0.90|0.63|
71752928|NCT05526716|143008851|OTHER|Serotype 15C|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
71752929|NCT05526716|143008851|OTHER|Serotype 16F|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.99||||||||0.99|0.70|
71752930|NCT05526716|143008851|OTHER|Serotype 17F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
71752931|NCT05526716|143008851|OTHER|Serotype 19A|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||||0.93|0.71|
71752932|NCT05526716|143008851|OTHER|Serotype 20A|GMC Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.97||||||||0.97|0.70|
71752933|NCT05526716|143008851|OTHER|Serotype 22F|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||||1.10|0.80|
71752934|NCT05526716|143008851|OTHER|Serotype 23A|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.7|1.03||||||||1.03|0.70|
71752935|NCT05526716|143008851|OTHER|Serotype 23B|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||||1.02|0.72|
71752936|NCT05526716|143008851|OTHER|Serotype 24F|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
71752937|NCT05526716|143008851|OTHER|Serotype 31|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
71752938|NCT05526716|143008851|OTHER|Serotype 33F|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.69|0.94||||||||0.94|0.69|
71784672|NCT00903695|143068366|SUPERIORITY_OR_OTHER|||||||0.24||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.7, t-test = 1.3"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.24
71784673|NCT00903695|143068367|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 0.15, t-test = 0.39"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.71
71784674|NCT00903695|143068368|SUPERIORITY_OR_OTHER|||||||0.18||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 2.25, ttest = -1.5"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.18
71784675|NCT00903695|143068369|SUPERIORITY_OR_OTHER|||||||0.34||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.06, t-test = -1.03"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).||||0.34
71752939|NCT05526716|143008851|OTHER|Serotype 35B|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.72|0.99||||||||0.99|0.72|
71752940|NCT04742556|143008863|OTHER||Probability of true DLT rate in [0.33-1]|0.0051||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71752941|NCT04742556|143008863|OTHER||Probability of true DLT rate in [0.33-1]|0.03105||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71752942|NCT04742556|143008863|OTHER||Probability of true DLT rate in [0.33-1]|0.27405||||||||||||||Probability of true DLT rate was determined using a Bayesian 2-parameter logistic regression model with overdose control.||||
71752943|NCT03631940|143008872|SUPERIORITY||Least squares mean difference|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||Hierarchical generalized linear mixed mo|Hierarchical generalized linear mixed models||||5.37|-6.36|.87
71752944|NCT02201524|143008897|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-5.08|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|90.0|-9.15|-1.01||||||PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.01|-9.15|
71752945|NCT02201524|143008897|SUPERIORITY_OR_OTHER||LS mean difference|-5.61|STANDARD_ERROR_OF_MEAN|2.375|||TWO_SIDED|90.0|-9.61|-1.62||||||PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.62|-9.61|
71752946|NCT02201524|143008897|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|STANDARD_ERROR_OF_MEAN|2.506|||TWO_SIDED|90.0|-14.19|-5.77||||||PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.77|-14.19|
71752947|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-9.32|STANDARD_ERROR_OF_MEAN|8.291|||TWO_SIDED|90.0|-23.19|4.56||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||4.56|-23.19|
71752948|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-11.19|STANDARD_ERROR_OF_MEAN|8.177|||TWO_SIDED|90.0|-24.87|2.5||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.50|-24.87|
71752949|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-19.22|STANDARD_ERROR_OF_MEAN|8.504|||TWO_SIDED|90.0|-33.45|-4.99||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.99|-33.45|
71752950|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.387|||TWO_SIDED|90.0|-21.71|13.11||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||13.11|-21.71|
71752951|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.273|||TWO_SIDED|90.0|-35.25|-0.82||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.82|-35.25|
71752952|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-27.07|STANDARD_ERROR_OF_MEAN|10.646|||TWO_SIDED|90.0|-44.9|-9.23||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-9.23|-44.90|
71752953|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|11.013|||TWO_SIDED|90.0|-28.53|8.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.39|-28.53|
71752954|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-29.23|STANDARD_ERROR_OF_MEAN|10.793|||TWO_SIDED|90.0|-47.33|-11.13||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.13|-47.33|
71752955|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-49.99|STANDARD_ERROR_OF_MEAN|11.299|||TWO_SIDED|90.0|-68.92|-31.05||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-31.05|-68.92|
71752956|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-24.25|STANDARD_ERROR_OF_MEAN|11.33|||TWO_SIDED|90.0|-43.26|-5.24||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.24|-43.26|
71752957|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-27.47|STANDARD_ERROR_OF_MEAN|11.155|||TWO_SIDED|90.0|-46.18|-8.75||||||PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-8.75|-46.18|
71752958|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-52.63|STANDARD_ERROR_OF_MEAN|11.697|||TWO_SIDED|90.0|-72.24|-33.02||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-33.02|-72.24|
71752959|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-17.98|STANDARD_ERROR_OF_MEAN|10.605|||TWO_SIDED|90.0|-35.8|-0.15|||LANCOVA|||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.15|-35.80|
71752960|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-14.78|STANDARD_ERROR_OF_MEAN|10.513|||TWO_SIDED|90.0|-32.44|2.88||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.88|-32.44|
71752961|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-47.94|STANDARD_ERROR_OF_MEAN|11.125|||TWO_SIDED|90.0|-66.61|-29.27||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-29.27|-66.61|
71752962|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean|-21.75|STANDARD_ERROR_OF_MEAN|11.459|||TWO_SIDED|90.0|-41.0|-2.49||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.49|-41.00|
71784676|NCT02111772|143068386|SUPERIORITY|||||||0.049|||||||Negative binomial regression|||||||0.049
71677147|NCT01194999|142872749|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No significant difference from baseline to final follow-up.||||0.001
71752963|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-17.75|STANDARD_ERROR_OF_MEAN|11.416|||TWO_SIDED|90.0|-36.92|1.42||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.42|-36.92|
71752964|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-35.88|STANDARD_ERROR_OF_MEAN|11.893|||TWO_SIDED|90.0|-55.85|-15.9||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-15.90|-55.85|
71752965|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|12.985|||TWO_SIDED|90.0|-32.57|11.07||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||11.07|-32.57|
71752966|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-13.03|STANDARD_ERROR_OF_MEAN|12.902|||TWO_SIDED|90.0|-34.71|8.64||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||8.64|-34.71|
71752967|NCT02201524|143008898|SUPERIORITY_OR_OTHER||LS mean difference|-34.46|STANDARD_ERROR_OF_MEAN|13.69|||TWO_SIDED|90.0|-57.44|-11.48||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-11.48|-57.44|
71752968|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.626|||TWO_SIDED|90.0|-4.73|0.72||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.72|-4.73|
71752969|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|1.603|||TWO_SIDED|90.0|-4.99|0.38||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.38|-4.99|
71752970|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|90.0|-6.45|-0.86||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.86|-6.45|
71752971|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.032|||TWO_SIDED|90.0|-4.49|2.32||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||2.32|-4.49|
71752972|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.011|||TWO_SIDED|90.0|-7.23|-0.49||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.49|-7.23|
71784677|NCT02111772|143068387|SUPERIORITY||||||<|0.001|||||||Negative binomial regression|||||||<0.001
71784678|NCT01603056|143068388|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||t-test, 2 sided|||||||0.743
71784679|NCT01603056|143068389|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||t-test, 2 sided|||||||0.627
71784680|NCT01603056|143068390|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||||||0.74
71784681|NCT01603056|143068391|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||t-test, 2 sided|||||||0.641
71784682|NCT01603056|143068392|SUPERIORITY_OR_OTHER|||||||0.818|TWO_SIDED||||||t-test, 2 sided|||||||0.818
71784683|NCT01603056|143068393|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||t-test, 2 sided|||||||0.391
71784684|NCT01603056|143068394|SUPERIORITY_OR_OTHER|||||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||0.497
71784685|NCT01603056|143068395|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||t-test, 2 sided|||||||0.222
71784686|NCT01603056|143068396|SUPERIORITY_OR_OTHER|||||||0.438|TWO_SIDED||||||Fisher Exact|||||||0.438
71784687|NCT01603056|143068397|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED||||||t-test, 2 sided|||||||0.465
71784688|NCT01603056|143068398|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|||||||0.123
71784689|NCT01603056|143068399|SUPERIORITY_OR_OTHER|||||||0.719|TWO_SIDED||||||t-test, 2 sided|||||||0.719
71784690|NCT01246401|143068411|SUPERIORITY|||||||0.431|||||||Welch's T Test|||||||0.431
71784691|NCT01246401|143068412|SUPERIORITY|||||||0.087|||||||Welch's T Test|||||||0.087
71784692|NCT01246401|143068414|SUPERIORITY|||||||0.03||||||Wilcoxon one sided|Wilcoxon (Mann-Whitney)|||||||0.03
71784693|NCT01246401|143068419|SUPERIORITY|||||||0.03962|||||||Chi-squared|||||||0.03962
71784694|NCT00919724|143068421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|0.6||0.1||||||Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.|Regression, Linear|||||||0.10
71784695|NCT00166114|143068422|SUPERIORITY_OR_OTHER|||||||0.918|||||||Chi-squared|||Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.||||.918
71784696|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.473|||||TWO_SIDED|95.0|-15.7096|26.6553|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1||26.6553|-15.7096|
71784697|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.598|||||TWO_SIDED|95.0|-21.784|20.5888|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1||20.5888|-21.7840|
71784698|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.906|||||TWO_SIDED|95.0|-9.3489|33.1602|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||33.1602|-9.3489|
71784699|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.671|||||TWO_SIDED|95.0|-16.9957|24.3384|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1||24.3384|-16.9957|
71784700|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.618|||||TWO_SIDED|95.0|-28.2069|37.4425|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1||37.4425|-28.2069|
71752973|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-5.16|STANDARD_ERROR_OF_MEAN|2.084|||TWO_SIDED|90.0|-8.65|-1.67||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.67|-8.65|
71836281|NCT01889199|143178243|OTHER||Mean Difference (Final Values)|1.12||||0.004|TWO_SIDED|||||a priori threshold p\<0.05|t-test, 2 sided|||Only PCOS women were randomized to flutamide versus placebo; controls were not randomized A sample size of 11 per group (PCOS women versus controls) provided adequate power (approximately 80%) to detect effect sizes as small as 1.25 using a two-sample t-test (alpha=0.05, 2 tailed). A sample size of 5 per group (flutamide-treated versus placebo-treated PCOS women) also gave adequate power (approximately 80%) to detect effect sizes as small as 2 using a two-sample t-test (alpha=0.05, 2 tailed).||||0.004
71752974|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-2.34|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|90.0|-6.07|1.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.39|-6.07|
71752975|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-6.12|STANDARD_ERROR_OF_MEAN|2.177|||TWO_SIDED|90.0|-9.78|-2.47||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.47|-9.78|
71752976|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-9.39|STANDARD_ERROR_OF_MEAN|2.286|||TWO_SIDED|90.0|-13.22|-5.56||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-5.56|-13.22|
71752977|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-3.25|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|90.0|-6.71|0.21||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.21|-6.71|
71752978|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|2.035|||TWO_SIDED|90.0|-6.4|0.45||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.45|-6.40|
71752979|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-8.59|STANDARD_ERROR_OF_MEAN|2.167|||TWO_SIDED|90.0|-12.24|-4.95||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-4.95|-12.24|
71752980|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-3.98|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|90.0|-7.89|-0.08||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-0.08|-7.89|
71752981|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|2.304|||TWO_SIDED|90.0|-7.68|0.07||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||0.07|-7.68|
71752982|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.412|||TWO_SIDED|90.0|-11.0|-2.89||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-2.89|-11.00|
71752983|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|2.607|||TWO_SIDED|90.0|-5.65|3.11||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||3.11|-5.65|
71836282|NCT01889199|143178244|OTHER||Mean Difference (Net)|0.024|||||TWO_SIDED|||||||||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||
71836283|NCT01889199|143178246|OTHER||Mean Difference (Net)|0.04||||0.04|TWO_SIDED||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.040
71836284|NCT01889199|143178247|OTHER|||||||0.034|||||||t-test, 2 sided|||6-month changes from baseline were compared between placebo- and flutamide-treated PCOS women using an unpaired Student's t-test to determine whether one group changed more than the other over this time interval.||||0.034
71752984|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|2.586|||TWO_SIDED|90.0|-7.18|1.51||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||1.51|-7.18|
71752985|NCT02201524|143008899|SUPERIORITY_OR_OTHER||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|2.758|||TWO_SIDED|90.0|-11.15|-1.89||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.||-1.89|-11.15|
71752986|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|90.0|-21.5|19.6||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||19.6|-21.5|
71752987|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-5.9|40.3||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||40.3|-5.9|
71752988|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|90.0|-9.3|38.0|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||38.0|-9.3|
71752989|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|-14.3|||||TWO_SIDED|90.0|-38.0|9.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||9.3|-38.0|
71752990|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|90.0|-25.4|29.1||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||29.1|-25.4|
71752991|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|20.2|||||TWO_SIDED|90.0|-10.2|48.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||48.3|-10.2|
71752992|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|1.9|||||TWO_SIDED|90.0|-26.7|31.0||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||31.0|-26.7|
71784701|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.713|||||TWO_SIDED|95.0|-17.0405|39.8527|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein A1||39.8527|-17.0405|
71784702|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.934|||||TWO_SIDED|95.0|-21.0153|31.5504|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein A1||31.5504|-21.0153|
71784703|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.466|||||TWO_SIDED|95.0|-23.7517|24.7608|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein A1||24.7608|-23.7517|
71784704|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.743|||||TWO_SIDED|95.0|-3.246|33.7161|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100||33.7161|-3.2460|
71784705|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.428|||||TWO_SIDED|95.0|-21.3243|8.9224|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.9224|-21.3243|
71784706|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.96|||||TWO_SIDED|95.0|-26.8137|1.1513|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||1.1513|-26.8137|
71784707|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.903|||||TWO_SIDED|95.0|-16.6557|13.1191|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100||13.1191|-16.6557|
71784708|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.231|||||TWO_SIDED|95.0|-45.1045|-11.3579|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100||-11.3579|-45.1045|
71752993|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|23.6|||||TWO_SIDED|90.0|-6.9|49.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||49.8|-6.9|
71752994|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|67.8|||||TWO_SIDED|90.0|36.4|85.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||85.3|36.4|
71784709|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||||TWO_SIDED|95.0|-23.5021|11.3014|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein B100||11.3014|-23.5021|
71784710|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.49|||||TWO_SIDED|95.0|-25.2721|8.2918|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein B100||8.2918|-25.2721|
71784711|NCT01218204|143068461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.687|||||TWO_SIDED|95.0|-26.0247|6.6498|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein B100||6.6498|-26.0247|
71784712|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.471|||||TWO_SIDED|95.0|-47.9323|3.202|||||Statistical analysis was performed using LS mean value Atorvastatin|||3.2020|-47.9323|
71784713|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.91|||||TWO_SIDED|95.0|-38.1027|25.3126|||||Statistical analysis was performed using LS mean value Atorvastatin|||25.3126|-38.1027|
71784714|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.985|||||TWO_SIDED|95.0|-45.5492|1.8605|||||Statistical analysis was performed using LS mean value Atorvastatin|||1.8605|-45.5492|
71677148|NCT03834974|142872775|SUPERIORITY||||||<|0.0286|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in intent to tan outdoors 10 or more times in the next year.||||<0.0286
71784715|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.697|||||TWO_SIDED|95.0|-45.0846|13.3024|||||Statistical analysis was performed using LS mean value Atorvastatin|||13.3024|-45.0846|
71784716|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.036|||||TWO_SIDED|95.0|-27.2281|15.1569|||||Statistical analysis was performed using LS mean value of Atorvastatin|||15.1569|-27.2281|
71784717|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.198|||||TWO_SIDED|95.0|-24.2901|32.6057|||||Statistical analysis was performed using LS mean value of GSK1292263|||32.6057|-24.2901|
71784718|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.117|||||TWO_SIDED|95.0|-40.4767|1.906|||||Statistical analysis was performed using LS mean value of GSK1292263|||1.9060|-40.4767|
71784719|NCT01218204|143068462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.798|||||TWO_SIDED|95.0|-48.3842|-12.5064|||||Statistical analysis was performed using LS mean value of GSK1292263|||-12.5064|-48.3842|
71784720|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.101|||||TWO_SIDED|95.0|-4.5469|14.7495|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||14.7495|-4.5469|
71784721|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.273|||||TWO_SIDED|95.0|2.5937|21.9532|||||Statistical analysis was performed using LS mean value of Atorvastatin|Fo HDLc||21.9532|2.5937|
71752995|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
71784722|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.833|||||TWO_SIDED|95.0|18.955|38.7102|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||38.7102|18.9550|
71752996|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|7.6|67.1||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||67.1|7.6|
71752997|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|55.0|||||TWO_SIDED|90.0|19.7|77.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||77.6|19.7|
71784723|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.701|||||TWO_SIDED|95.0|-5.5562|12.9578|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||12.9578|-5.5562|
71784724|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.946|||||TWO_SIDED|95.0|8.612|33.281|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc||33.2810|8.6120|
71784725|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.561|||||TWO_SIDED|95.0|-0.9675|22.0898|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.0898|-0.9675|
71784726|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.122|||||TWO_SIDED|95.0|-0.2902|22.5351|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||22.5351|-0.2902|
71836285|NCT02323321|143178250|OTHER|The primary hypothesis for this study is that the true (success) proportion of transplanted patients meeting the primary effectiveness endpoint, patient survival at day 30 post-transplantation and absence of severe PGD (left or right ventricle) in the first 24 hours post-transplantation, is greater than the Performance Goal value of 0.65.|Proportion|88.0|||<|0.0001|TWO_SIDED|95.0|78.4|94.4|||one-sided exact binomial test|||||94.4|78.4|<0.0001
71836286|NCT00446225|143178251|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0001|TWO_SIDED|95.0|0.27|0.64|||Log Rank|||||0.64|0.27|0.0001
71836287|NCT00446225|143178253|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.043|TWO_SIDED|95.0|0.36|0.99|||Log Rank|||||0.99|0.36|0.043
71836288|NCT00220740|143178291|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.||||<0.001
71836289|NCT00220740|143178292|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||ANCOVA|||||||0.542
71836290|NCT00220740|143178293|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Dominant hand||||<0.001
71836291|NCT00220740|143178293|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||Non-dominant hand||||0.005
71836292|NCT02814838|143178355|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.3303|TWO_SIDED|95.0|-0.14|0.42|||Student's t test for unpaired samples|||Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.||0.42|-0.14|0.3303
71836293|NCT02814838|143178356|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|0.0984||||0.517|TWO_SIDED|95.0|-0.2028|0.3995|||Mixed Models Analysis|||at FUP week 26||0.3995|-0.2028|0.517
71836294|NCT02814838|143178356|SUPERIORITY|The comparisons between groups on 2-hour AUC C-peptide efficacy endpoint was carried-out using a mixed linear model where the log(x+1) transformed 2-hour AUC C-peptide was the dependent variable, while treatment group, visit, treatment by visit interaction were the fixed factors of the model and patient will be the random effect. An unstructured covariance matrix for each patient is considered and the Kenward-Roger adjustment is used for the degrees of freedom.|adjusted mean difference|-0.0486||||0.7999|TWO_SIDED|95.0|-0.4294|0.3322|||Mixed Models Analysis|||At FUP week 52||0.3322|-0.4294|0.7999
71836295|NCT02814838|143178357|SUPERIORITY||adjusted mean difference|12.0411||||0.2224|TWO_SIDED|95.0|-7.3823|31.4644|||Mixed Models Analysis|||at week 13||31.4644|-7.3823|0.2224
71836296|NCT02814838|143178357|SUPERIORITY||adjusted mean difference|8.4803||||0.3931|TWO_SIDED|95.0|-11.0935|28.0541|||Mixed Models Analysis|||At week 26||28.0541|-11.0935|0.3931
71836297|NCT02814838|143178357|SUPERIORITY||adjusted mean difference|-2.9502||||0.7664|TWO_SIDED|95.0|-22.5476|16.6473|||Mixed Models Analysis|||At week 52||16.6473|-22.5476|0.7664
71836298|NCT02814838|143178358|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.048||||0.2225|TWO_SIDED|95.0|-0.1257|0.0298|||Mixed Models Analysis|||at week 13||0.0298|-0.1257|0.2225
71836299|NCT02814838|143178358|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.0369||||0.551|TWO_SIDED|95.0|-0.1596|0.0858|||Mixed Models Analysis|||at week 26||0.0858|-0.1596|0.551
71836300|NCT02814838|143178358|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Daily Insulin Requirement (IU/kg/day) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.063||||0.2501|TWO_SIDED|95.0|-0.1712|0.0453|||Mixed Models Analysis|||at week 52||0.0453|-0.1712|0.2501
71836301|NCT02814838|143178359|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.1494||||0.6252|TWO_SIDED|95.0|-0.7514|0.4526|||Mixed Models Analysis|||at FU week 13||0.4526|-0.7514|0.6252
71836302|NCT02814838|143178359|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2804||||0.366|TWO_SIDED|95.0|-0.8904|0.3297|||Mixed Models Analysis|||At FU week 26||0.3297|-0.8904|0.366
71836303|NCT02814838|143178359|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with HbA1c (%) as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|-0.2063||||0.5026|TWO_SIDED|95.0|-0.3992|0.8118|||Mixed Models Analysis|||At FU week 52||0.8118|-0.3992|0.5026
71836304|NCT02814838|143178360|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0242||||0.2527|TWO_SIDED|95.0|-0.0174|0.0658|||Mixed Models Analysis|||at week 13||0.0658|-0.0174|0.2527
71836305|NCT02814838|143178360|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|0.0236||||0.2743|TWO_SIDED|95.0|-0.0188|0.066|||Mixed Models Analysis|||at week 26||0.066|-0.0188|0.2743
71836306|NCT02814838|143178360|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with C-peptide (nmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0059||||0.7856|TWO_SIDED|95.0|-0.0485|0.0367|||Mixed Models Analysis|||at week 52||0.0367|-0.0485|0.7856
71784727|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.689|||||TWO_SIDED|95.0|9.7527|31.6262|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc||31.6262|9.7527|
71891839|NCT03193866|143305371|SUPERIORITY||Difference in proportion|-0.1|||||TWO_SIDED|95.0|-8.8|8.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.6|-8.8|
71891840|NCT03193866|143305371|SUPERIORITY||Difference in proportion|-0.5|||||TWO_SIDED|95.0|-8.1|7.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.2|-8.1|
71677149|NCT03834974|142872775|SUPERIORITY|||||||0.0937|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in change in in intent to tan later in life.||||0.0937
71677150|NCT03834974|142872779|SUPERIORITY||||||<|0.0002|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There would be no difference in tanning outside at follow-up||||<0.0002
71784728|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.549|||||TWO_SIDED|95.0|-18.775|9.6768|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||9.6768|-18.7750|
71784729|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.337|||||TWO_SIDED|95.0|-24.4549|3.7803|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||3.7803|-24.4549|
71784730|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.317|||||TWO_SIDED|95.0|-36.0144|-6.619|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.6190|-36.0144|
71784731|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.173|||||TWO_SIDED|95.0|-34.271|-6.0755|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-6.0755|-34.2710|
71784732|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.472|||||TWO_SIDED|95.0|-49.3385|-8.1558|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc||-8.1558|-49.3385|
71784733|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.128|||||TWO_SIDED|95.0|-23.3049|-0.9514|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-0.9514|-23.3049|
71784734|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.798|||||TWO_SIDED|95.0|-27.1364|-4.4589|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-4.4589|-27.1364|
71784735|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.789|||||TWO_SIDED|95.0|-32.3413|-11.2372|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc||-11.2372|-32.3413|
71784736|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.498|||||TWO_SIDED|95.0|-38.446|-2.4169|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-2.4169|-38.4460|
71784737|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.781|||||TWO_SIDED|95.0|-39.1603|-4.513|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-4.5130|-39.1603|
71784738|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.923|||||TWO_SIDED|95.0|-52.3394|-24.2717|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-24.2717|-52.3394|
71784739|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.444|||||TWO_SIDED|95.0|-33.502|2.491|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||2.4910|-33.5020|
71784740|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.781|||||TWO_SIDED|95.0|-40.296|-3.2667|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides||-3.2667|-40.2960|
71784741|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.421|||||TWO_SIDED|95.0|-38.3519|-4.4911|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-4.4911|-38.3519|
71784742|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.361|||||TWO_SIDED|95.0|-63.465|-29.2561|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-29.2561|-63.4650|
71784743|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.843|||||TWO_SIDED|95.0|-70.7854|-38.9007|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides||-38.9007|-70.7854|
71784744|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.756|||||TWO_SIDED|95.0|-21.7561|2.2448|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||2.2448|-21.7561|
71784745|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.014|||||TWO_SIDED|95.0|-25.7497|-2.2787|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-2.2787|-25.7497|
71784746|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.675|||||TWO_SIDED|95.0|-39.8454|-15.5045|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-15.5045|-39.8454|
71784747|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.937|||||TWO_SIDED|95.0|-32.6057|-9.269|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-9.2690|-32.6057|
71784748|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.702|||||TWO_SIDED|95.0|-29.0346|-14.3696|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc||-14.3696|-29.0346|
71784749|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.18|||||TWO_SIDED|95.0|-23.0636|-3.2961|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-3.2961|-23.0636|
71784750|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.151|||||TWO_SIDED|95.0|-31.942|-12.3605|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-12.3605|-31.9420|
71836307|NCT02814838|143178361|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.0253||||0.9307|TWO_SIDED|95.0|-0.5986|0.548|||Mixed Models Analysis|||at week 13||0.548|-0.5986|0.9307
71836308|NCT02814838|143178361|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.7236||||0.0139|TWO_SIDED|95.0|-1.2989|-0.1483|||Mixed Models Analysis|||At week 26||-0.1483|-1.2989|0.0139
71836309|NCT02814838|143178361|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with Glucose (mmol/L) actual value as dependent variable, treatment, visit, time, treatment by visit interaction, time by visit interaction, treatment by visit by time interaction as fixed effects and time by visit interaction is specified in repeated statement.|adjusted mean difference|-0.5979||||0.0432|TWO_SIDED|95.0|-1.1775|-0.0184|||Mixed Models Analysis|||at week 52||-0.0184|-1.1775|0.0432
71836310|NCT02814838|143178363|SUPERIORITY|||||||0.1171|||||||Fisher Exact|||at week 13||||0.1171
71836311|NCT02814838|143178363|SUPERIORITY|||||||0.6586|||||||Fisher Exact|||At week 26||||0.6586
71836312|NCT02814838|143178363|SUPERIORITY|||||||0.5056|||||||Fisher Exact|||At week 52||||0.5056
71836313|NCT02814838|143178364|SUPERIORITY|||||||0.0779|||||||Fisher Exact|||at week 13||||0.0779
71836314|NCT02814838|143178364|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||At week 26||||0.0248
71836315|NCT02814838|143178364|SUPERIORITY|||||||0.4504|||||||Fisher Exact|||At week 52||||0.4504
71836316|NCT02814838|143178365|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.1402||||0.4163|TWO_SIDED|95.0|-0.2015|0.4819|||Mixed Models Analysis|||At week 13||0.4819|-0.2015|0.4163
71891841|NCT03193866|143305371|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-5.7|8.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.9|-5.7|
71896242|NCT00479466|143314601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.4|||<|0.001|TWO_SIDED|95.0|-109.4|-65.3|||ANCOVA|||||-65.3|-109.4|<0.001
71677151|NCT00090220|142872796|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|88.7||||||95.0|78.1|94.8|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||94.8|78.1|
71677152|NCT00090220|142872822|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|94.8||||||95.0|79.9|99.4|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||99.4|79.9|
71836317|NCT02814838|143178365|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.177||||0.3575|TWO_SIDED|95.0|-0.2039|0.558|||Mixed Models Analysis|||At week 26||0.558|-0.2039|0.3575
71836318|NCT02814838|143178365|SUPERIORITY|Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction as fixed effects and patient as random effect.|adjusted mean difference|0.0451||||0.8386|TWO_SIDED|95.0|-0.3948|0.4851|||Mixed Models Analysis|||At week 52||0.4851|-0.3948|0.8386
71836319|NCT02814838|143178366|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.354|||=|0.1114|TWO_SIDED|95.0|-0.09|0.75|||t-test, 2 sided|||At week 13||0.75|-0.09|= 0.1114
71836320|NCT02814838|143178366|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.502|||=|0.0411|TWO_SIDED|95.0|0.02|0.98|||t-test, 2 sided|||At week 26||0.98|0.02|= 0.0411
71836321|NCT02814838|143178366|SUPERIORITY|Transformed AUC was analyzed with Student t-test for unpaired data using PROC TTEST within SAS® to compare Ladarixin and placebo groups. The estimated treatment difference between Ladarixin and placebo was also presented together with the corresponding 95% confidence interval.|Mean Difference (Final Values)|0.223|||=|0.4506|TWO_SIDED|95.0|-0.37|0.82|||t-test, 2 sided|||At week 52||0.82|-0.37|= 0.4506
71836322|NCT02814838|143178367|SUPERIORITY||Adjusted mean difference|0.3631||||0.1847|TWO_SIDED|95.0|-0.1817|0.908|||Mixed Models Analysis|||Week 13 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.908|-0.1817|0.1847
71836323|NCT02814838|143178367|SUPERIORITY||Adjusted mean difference|0.6304||||0.031|TWO_SIDED|95.0|0.0609|1.1998|||Mixed Models Analysis|||Week 26 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||1.1998|0.0609|0.031
71836324|NCT02814838|143178367|SUPERIORITY||Adjusted mean difference|0.1639||||0.6299|TWO_SIDED|95.0|-0.5202|0.8479|||Mixed Models Analysis|||Week 52 Analysis is based on a linear mixed model for repeated measures with log(AUC(15-120 minutes)+1) of C-peptide above fasting value as dependent variable, treatment, visit and treatment by visit interaction||0.8479|-0.5202|0.6299
71836325|NCT02814838|143178368|SUPERIORITY|||||||0.163|||||||Fisher Exact|||Week 13||||0.163
71836326|NCT02814838|143178368|SUPERIORITY|||||||0.0074|||||||Fisher Exact|||Week 26||||0.0074
71896243|NCT00479466|143314601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.6|||<|0.001|TWO_SIDED|95.0|-124.2|-79.1|||ANCOVA|||||-79.1|-124.2|<0.001
71896244|NCT00479466|143314601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.8|||<|0.001|TWO_SIDED|95.0|-82.7|-38.8|||ANCOVA|||||-38.8|-82.7|<0.001
71891842|NCT03193866|143305371|SUPERIORITY||Difference in proportion|1.6|||||TWO_SIDED|95.0|-4.7|8.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.0|-4.7|
71677153|NCT00090220|142872830|SUPERIORITY_OR_OTHER||Percent Relative Risk Reduction|84.7||||||95.0|67.5|93.7|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.|||93.7|67.5|
71784751|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.948|||||TWO_SIDED|95.0|-36.2874|-17.6092|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc||-17.6092|-36.2874|
71784752|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.904|||||TWO_SIDED|95.0|-11.8484|4.04|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||4.0400|-11.8484|
71784753|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.437|||||TWO_SIDED|95.0|-14.346|1.4722|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||1.4722|-14.3460|
71784754|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.294|||||TWO_SIDED|95.0|-18.3923|-2.196|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-2.1960|-18.3923|
71784755|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.065|||||TWO_SIDED|95.0|-19.7688|-4.3609|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-4.3609|-19.7688|
71784756|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.941|||||TWO_SIDED|95.0|-13.9778|-1.9039|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol||-1.9039|-13.9778|
71784757|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.384|||||TWO_SIDED|95.0|-15.9023|-0.866|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-0.8660|-15.9023|
71784758|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.7|||||TWO_SIDED|95.0|-23.1404|-8.2592|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol||-8.2592|-23.1404|
71784759|NCT01218204|143068463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.728|||||TWO_SIDED|95.0|-23.8395|-9.6161||||||For Cholesterol||-9.6161|-23.8395|
71784760|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.123|||||TWO_SIDED|95.0|-26.6276|2.3814|||||Statistical analysis was performed using LS mean value of Atorvastatin|||2.3814|-26.6276|
71677154|NCT00537316|142872845|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Chi-squared|||||||0.032
71784761|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.63|||||TWO_SIDED|95.0|-35.9419|-7.3181|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-7.3181|-35.9419|
71784762|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-41.506|||||TWO_SIDED|95.0|-56.3924|-26.6205|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-26.6205|-56.3924|
71784763|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.041|||||TWO_SIDED|95.0|-42.2554|-13.8263|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-13.8263|-42.2554|
71784764|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.293|||||TWO_SIDED|95.0|-51.5654|-12.4042|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-12.4042|-51.5654|
71784765|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.042|||||TWO_SIDED|95.0|-34.8358|-5.2472|||||Statistical analysis was performed using LS mean value of GSK1292263|||-5.2472|-34.8358|
71784766|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.903|||||TWO_SIDED|95.0|-36.6155|-7.1913|||||Statistical analysis was performed using LS mean value of GSK1292263|||-7.1913|-36.6155|
71784767|NCT01218204|143068464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.735|||||TWO_SIDED|95.0|-49.722|-21.7485|||||Statistical analysis was performed using LS mean value of GSK1292263|||-21.7485|-49.7220|
71784768|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.409|||||TWO_SIDED|95.0|-1.0123|0.1942|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1942|-1.0123|
71784769|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.296|||||TWO_SIDED|95.0|-0.9063|0.3141|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.3141|-0.9063|
71784770|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.811|||||TWO_SIDED|95.0|-1.4125|-0.2098|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.2098|-1.4125|
71784771|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.422|||||TWO_SIDED|95.0|-0.9831|0.1394|||||Statistical analysis was performed using LS mean value of Atorvastatin|||0.1394|-0.9831|
71784772|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.384|||||TWO_SIDED|95.0|-0.6009|-0.1669|||||Statistical analysis was performed using LS mean value of Atorvastatin|||-0.1669|-0.6009|
71784773|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.648|||||TWO_SIDED|95.0|-1.1657|-0.1302|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.1302|-1.1657|
71784774|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.782|||||TWO_SIDED|95.0|-1.2804|-0.2844|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.2844|-1.2804|
71784775|NCT01218204|143068465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.884|||||TWO_SIDED|95.0|-1.3652|-0.4026|||||Statistical analysis was performed using LS mean value of GSK1292263|||-0.4026|-1.3652|
71784776|NCT00489541|143068486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||t-test, 2 sided|||A superiority test of TAXUX Element vs bare metal (BMS) Express historical control. The null hypothesis that the true difference in means (TAXUS Element - BMS Express) is equal to zero was tested against the two-sided alternative that the true difference in means is different from zero. A sample size of 224 patients in the TAXUS Element group (190 after 15% attrition due to angiographic follow-up) provided 85% power.||-0.30|-0.54|<0.0001
71784777|NCT00489541|143068487|SUPERIORITY_OR_OTHER||12-month TLR rate|7.34|||<|0.0001|ONE_SIDED|95.0||10.8|||Chi-squared|||One-sided, single-sample binomial test to compare the observed TLF rate in PERSEUS SV to the pre-specified performance goal (19.5%). The normal approximation of the test statistic was used. The null hypothesis that the true TAXUS Element TLF rate is greater than or equal to the performance goal was tested against the one-sided alternative that the true rate is less than the performance goal. A sample size of 224 patients (accounting for 5% attrition to follow-up) provided 80% power.||10.8||<0.0001
71677155|NCT00823043|142872851|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<.001
71836327|NCT02814838|143178368|SUPERIORITY|||||||0.4437|||||||Fisher Exact|||Week 52||||0.4437
71836328|NCT03811366|143178369|OTHER||||||<|0.001||||||significance when p\<0;05|generalized estimated equation|generalized estimated equation with normal distribution and logarithmic link function||||||<0.001
71836329|NCT03811366|143178372|OTHER|||||||0.054||||||significance when p\<0.05|Fisher Exact|||Recurrence or worsening of cells in anterior chamber in ERG-stable and ERG worsening group.||||0.054
71836330|NCT03811366|143178373|OTHER|||||||0.478||||||17 eyes presented dark dots fluctuation during follow up in stable ERG group when compared to 5 eyes in worsening ERG group.|generalized estimated equation|Generalized estimated equation with Poisson distribution and identity link function supposing an interchangeable correlation matrix between the eyes||||||0.478
71836331|NCT03811366|143178375|OTHER|9 (52.9%) eyes in ERG stable group x 4 (57.1%)eyes presented change in perivascular leakage during follow up (p=0.936).||||||0.936|||||||Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||Change in perivascular leakage in ERG-stable and ERG- worsening groups.||||0.936
71836332|NCT03811366|143178376|OTHER|||||||0.853||||||significance when p\<0.05|Generalized estimated equation|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;||||||0.853
71836333|NCT03811366|143178377|OTHER|||||||0.272||||||significance when p\<0.05|Fisher Exact|||||||0.272
71836334|NCT03811366|143178378|OTHER|||||||0.983||||||significance when p\<0.05|Generalized estimated equation with bino|Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes||||||0.983
71836335|NCT02596126|143178384|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI). If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.76|||<|0.025|TWO_SIDED|95.0|0.6|0.96|||Regression, Cox|||||0.96|0.6|< 0.025
71836336|NCT02596126|143178384|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71836337|NCT02596126|143178385|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Risk Ratio (RR)|1.13|||<|0.005|TWO_SIDED|95.0|1.06|1.2|||Chi-squared|||Statistical analysis title - Treatment adherence at 6 months||1.2|1.06|< 0.005
71836338|NCT02596126|143178386|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|0.97|||<|0.05|TWO_SIDED|95.0|0.75|1.25|||Log Rank|||Statistical analysis title - All-cause death||1.25|0.75|< 0.05
71836339|NCT02596126|143178387|EQUIVALENCE|Treatment adherence is measured at visit 1 (6 months) and visit 3 (24 months) using the Morisky- Medication Adherence Scale (8 item) Questionnaire (MMAS-8). The number and percentage of patients with low (0-5), medium (6-7) and high(8) adherence will be reported by treatment group. The distributions of the MMAS-8 score at 6 months and 24 months will be compared between treatment groups using an ordinal logistic regression model.|Hazard Ratio (HR)|1.17|||<|0.005|TWO_SIDED|95.0|1.1|1.25|||Chi-squared|||Statistical analysis title - Treatment adherence at 24 months||1.25|1.1|< 0.005
71836340|NCT02596126|143178388|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.3|||<|0.05|TWO_SIDED|95.0|-1.8|1.2||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 6 months||1.2|-1.8|< 0.05
71836341|NCT02596126|143178389|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|1.4|||<|0.05|TWO_SIDED|95.0|-0.1|3.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 12 months||3|-0.1|< 0.05
71836342|NCT02596126|143178390|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-1.7|1.4||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - SBP - 24 months||1.4|-1.7|< 0.05
71891843|NCT03193866|143305371|SUPERIORITY||Difference in proportion|0.9|||||TWO_SIDED|95.0|-6.2|7.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.9|-6.2|
71752998|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|12.1|||||TWO_SIDED|90.0|-21.4|43.4||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||43.4|-21.4|
71752999|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|3.8|||||TWO_SIDED|90.0|-29.4|36.4||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-29.4|
71753000|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|45.5|||||TWO_SIDED|90.0|17.1|69.0||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||69.0|17.1|
71753001|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|1.9|63.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||63.4|1.9|
71753002|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|14.5|||||TWO_SIDED|90.0|-21.4|47.0||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||47.0|-21.4|
71753003|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|24.5|||||TWO_SIDED|90.0|-11.8|54.9||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-11.8|
71753004|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|-4.5|||||TWO_SIDED|90.0|-40.4|32.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||32.3|-40.4|
71753005|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-23.7|48.2||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.2|-23.7|
71753006|NCT02201524|143008900|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-28.0|49.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|-28.0|
71753007|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
71753008|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
71753009|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|8.2|||||TWO_SIDED|90.0|-14.4|32.2||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||32.2|-14.4|
71753010|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-6.7|43.6||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||43.6|-6.7|
71784778|NCT03266107|143068495|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71784779|NCT03266107|143068496|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71753011|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.7|||||TWO_SIDED|90.0|-28.8|12.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||12.1|-28.8|
71784780|NCT03266107|143068499|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71784781|NCT01191801|143068551|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.0305|ONE_SIDED|95.0||||Unstratified one sided P-Value|Unstratified Log Rank|Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).||||||0.0305
71753012|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|32.3|||||TWO_SIDED|90.0|5.4|55.4||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.4|5.4|
71753013|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|90.0|0.8|55.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.3|0.8|
71753014|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-27.3|27.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||27.3|-27.3|
71753015|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|1.0|59.8||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||59.8|1.0|
71753016|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|43.3|||||TWO_SIDED|90.0|8.8|69.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||69.3|8.8|
71753017|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
71753018|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|50.0|||||TWO_SIDED|90.0|25.4|71.8||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||71.8|25.4|
71753019|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|66.7|||||TWO_SIDED|90.0|39.2|86.1||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||86.1|39.2|
71753020|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.1|||||TWO_SIDED|90.0|-36.3|18.3||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||18.3|-36.3|
71753021|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|41.8|||||TWO_SIDED|90.0|6.2|68.5||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||68.5|6.2|
71753022|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|31.8|||||TWO_SIDED|90.0|-2.9|60.5||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||60.5|-2.9|
71753023|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.9|||||TWO_SIDED|90.0|-47.8|13.7||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||13.7|-47.8|
71753024|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|-6.8|||||TWO_SIDED|90.0|-40.6|24.8||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-40.6|
71753025|NCT02201524|143008901|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|90.0|-36.4|36.4||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||36.4|-36.4|
71753026|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
71753027|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|-7.1|||||TWO_SIDED|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||10.2|-27.0|
71753028|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|0.5|||||TWO_SIDED|90.0|-20.7|22.8||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||22.8|-20.7|
71836343|NCT02596126|143178391|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|95.0|-0.7|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 6 months||1|-0.7|< 0.05
71896245|NCT02255838|143314606|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|paired t-test||||||<0.05
71753029|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|1.2|||||TWO_SIDED|90.0|-20.3|24.8||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||24.8|-20.3|
71753030|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-5.6|33.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-5.6|
71753031|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|36.4|||||TWO_SIDED|90.0|15.3|61.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||61.1|15.3|
71753032|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|33.3|||||TWO_SIDED|90.0|11.3|57.3||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||57.3|11.3|
71753033|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|60.0|||||TWO_SIDED|90.0|34.7|80.9||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||80.9|34.7|
71753034|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|2.1|49.3||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||49.3|2.1|
71753035|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|44.4|||||TWO_SIDED|90.0|19.4|70.2||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||70.2|19.4|
71784782|NCT01191801|143068552|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
71784783|NCT01191801|143068555|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Two sided P-Value|Chi-squared|||||||<0.0001
71784784|NCT01191801|143068556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||<|0.0001|ONE_SIDED|95.0||||Unstratified one-sided P-Value|Log Rank|||||||<0.0001
71784785|NCT01191801|143068557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3134|TWO_SIDED|95.0||||One sided P-Value|Log Rank|||||||0.3134
71784786|NCT02221947|143068606|OTHER||mean Tmax(h)|0.92|||||TWO_SIDED||||||||SD=0.206|Bryostatin plasma concentration: mean Tmax (h)||||
71784787|NCT02221947|143068606|OTHER||mean (h*ng/mL)|1.05|||||TWO_SIDED||||||||SD=0.330|Bryostatin plasma concentration AUC0-last (h\*ng/mL)||||
71784788|NCT00114101|143068607|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.|Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.53||Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.|Log Rank|||||0.53|0.26|<0.001
71784789|NCT00114101|143068609|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52||||0.7|TWO_SIDED|95.0|0.26|1.02|||Log Rank|||||1.02|0.26|0.70
71784790|NCT00114101|143068610|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.41|0.69|||Fisher Exact|||||0.69|0.41|<0.001
71784791|NCT00420927|143068684|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Chi-squared|P value is from Pearson's chi-square test.||||||0.023
71784792|NCT00420927|143068685|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Regression, Logistic|||||||0.082
71784793|NCT00420927|143068686|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Logistic|||||||0.280
71784794|NCT00420927|143068686|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Regression, Logistic|||||||0.287
71784795|NCT00420927|143068687|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Regression, Logistic|||||||0.026
71784796|NCT00420927|143068687|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Logistic|||||||0.009
71784797|NCT00420927|143068688|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
71784798|NCT00420927|143068688|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||Regression, Logistic|||||||0.063
71753036|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|20.0|||||TWO_SIDED|90.0|-2.7|46.6||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.6|-2.7|
71753037|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|30.0|||||TWO_SIDED|90.0|6.4|56.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||56.4|6.4|
71753038|NCT02201524|143008902|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-4.9|54.9||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||54.9|-4.9|
71753039|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|13.3|||||TWO_SIDED|90.0|-4.4|33.8||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||33.8|-4.4|
71753040|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-5.2|32.0||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||32.0|-5.2|
71753041|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|7.1|||||TWO_SIDED|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.||27.0|-10.2|
71753042|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|21.4|||||TWO_SIDED|90.0|-3.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-3.2|
71784799|NCT00420927|143068689|SUPERIORITY_OR_OTHER|||||||0.395||95.0|||||Regression, Logistic|||||||0.395
71784800|NCT00420927|143068689|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||Regression, Logistic|||||||0.640
71891844|NCT03193866|143305371|SUPERIORITY||Difference in proportion|-1.6|||||TWO_SIDED|95.0|-10.8|7.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||7.5|-10.8|
71891845|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.5|3.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.3|-2.5|
71891846|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|-4.5|||||TWO_SIDED|95.0|-12.5|3.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-12.5|
71891847|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.5|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-2.5|
71891848|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-4.9|-0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.1|-4.9|
71891849|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.6|1.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.1|-2.6|
71891850|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.2|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.2|
71891851|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-4.0|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-4.0|
71891852|NCT03193866|143305372|SUPERIORITY||Mean Difference (Net)|2.6|||||TWO_SIDED|95.0|-0.6|5.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.8|-0.6|
71891853|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-2.2|6.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.8|-2.2|
71891854|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|-8.3|||||TWO_SIDED|95.0|-20.3|3.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.7|-20.3|
71891855|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-2.6|3.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.5|-2.6|
71896246|NCT01508676|143314614|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||.04
71677156|NCT00823043|142872852|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||t-test, 2 sided|||||||0.024
71677157|NCT00823043|142872853|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
71896247|NCT02532543|143314617|SUPERIORITY|||||||0.863|||||||ANOVA|||||||0.863
71891856|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-5.8|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-5.8|
71896248|NCT02532543|143314618|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.718
71753043|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|15.9|||||TWO_SIDED|90.0|-8.1|40.7||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||40.7|-8.1|
71753044|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|34.5|||||TWO_SIDED|90.0|7.3|59.4||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.||59.4|7.3|
71753045|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|90.0|-11.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||45.5|-11.2|
71753046|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|31.3|||||TWO_SIDED|90.0|1.7|55.7||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||55.7|1.7|
71784801|NCT00420927|143068690|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Regression, Logistic|||||||0.159
71784802|NCT00420927|143068690|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Regression, Logistic|||||||0.217
71784803|NCT00420927|143068691|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Regression, Logistic|||||||0.060
71784804|NCT00420927|143068691|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Regression, Logistic|||||||0.043
71784805|NCT00420927|143068692|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.004
71784806|NCT00420927|143068692|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.049
71677158|NCT00823043|142872854|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||t-test, 2 sided|||||||0.69
71753047|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|30.1|||||TWO_SIDED|90.0|-1.2|57.4|||Difference in Percentage Analysed using|||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.||57.4|-1.2|
71784807|NCT00420927|143068693|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Regression, Logistic|||||||0.240
71784808|NCT00420927|143068693|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||Regression, Logistic|||||||0.271
71784809|NCT00420927|143068694|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Regression, Logistic|||||||0.230
71784810|NCT00420927|143068694|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Regression, Logistic|||||||0.550
71784811|NCT00420927|143068695|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Regression, Logistic|||||||0.301
71784812|NCT00420927|143068695|SUPERIORITY_OR_OTHER|||||||0.188||95.0|||||Regression, Logistic|||||||0.188
71784813|NCT00420927|143068696|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||Regression, Logistic|||||||0.314
71784814|NCT00420927|143068696|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||Regression, Logistic|||||||0.235
71784815|NCT00420927|143068697|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.030
71784816|NCT00420927|143068697|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.403
71784817|NCT00420927|143068698|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.036
71784818|NCT00420927|143068698|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.349
71784819|NCT00420927|143068699|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||0.037
71753048|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|25.0|||||TWO_SIDED|90.0|-6.4|52.5||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||52.5|-6.4|
71753049|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|41.7|||||TWO_SIDED|90.0|8.7|66.7||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||66.7|8.7|
71753050|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|53.3|||||TWO_SIDED|90.0|18.5|76.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.||76.6|18.5|
71753051|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|6.1|||||TWO_SIDED|90.0|-26.1|36.6||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||36.6|-26.1|
71753052|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|14.4|||||TWO_SIDED|90.0|-18.9|44.5||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||44.5|-18.9|
71753053|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|50.5|||||TWO_SIDED|90.0|12.9|75.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.||75.3|12.9|
71753054|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|9.1|||||TWO_SIDED|90.0|-25.2|41.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||41.4|-25.2|
71784820|NCT00420927|143068699|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance adjusting for baseline||||||<0.001
71784821|NCT00420927|143068700|SUPERIORITY_OR_OTHER|||||||0.192||95.0|||||Regression, Logistic|||||||0.192
71784822|NCT00420927|143068700|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Regression, Logistic|||||||0.241
71784823|NCT00420927|143068701|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|||||||0.028
71784824|NCT00420927|143068701|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Regression, Logistic|||||||0.014
71784825|NCT00420927|143068702|SUPERIORITY_OR_OTHER|||||||0.074||95.0|||||Regression, Logistic|||||||0.074
71784826|NCT00420927|143068702|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Regression, Logistic|||||||0.077
71784827|NCT00320411|143068754|SUPERIORITY_OR_OTHER||percentage of participants|17.2||||||95.0|8.6|29.4||||||||29.4|8.6|
71784828|NCT00320411|143068756|SUPERIORITY_OR_OTHER||percentage of participants|32.3||||||95.0|20.0|44.7||||||||44.7|20.0|
71784829|NCT00320411|143068757|SUPERIORITY_OR_OTHER||percentage of participants|22.8||||||95.0|11.6|34.0||||||||34.0|11.6|
71896249|NCT02532543|143314618|SUPERIORITY|||||||0.853|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.853
71891857|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.7|-2.9|
71891858|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-4.5|1.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.6|-4.5|
71891859|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-4.7|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-4.7|
71891860|NCT03193866|143305373|SUPERIORITY||Mean Difference (Net)|2.3|||||TWO_SIDED|95.0|-1.7|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-1.7|
71891861|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.39|||||TWO_SIDED|95.0|0.3|0.48||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.48|0.30|
71896250|NCT02532543|143314619|SUPERIORITY|||||||0.718|||||||ANOVA|||Comparison between each arm/group of change in mid buccal bone height||||0.718
71784830|NCT02397785|143068769|SUPERIORITY|||||||0.8979|||||||t-test, 2 sided|||It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.||||0.8979
71784831|NCT02397785|143068770|SUPERIORITY|||||||0.9338|||||||Sign test|||||||0.9338
71784832|NCT02397785|143068771|SUPERIORITY|||||||0.1568|||||||Sign test|||||||0.1568
71784833|NCT02397785|143068772|SUPERIORITY|||||||0.3817|||||||Sign test|||||||0.3817
71784834|NCT02397785|143068773|SUPERIORITY|||||||0.286|||||||Sign test|||||||0.2860
71784835|NCT02397785|143068774|SUPERIORITY|||||||0.2884|||||||Sign test|||||||0.2884
71784836|NCT02397785|143068775|SUPERIORITY|||||||0.0855|||||||Sign test|||||||0.0855
71784837|NCT02397785|143068776|SUPERIORITY|||||||0.0287|||||||Sign test|||||||0.0287
71784838|NCT02397785|143068777|SUPERIORITY|||||||0.2887|||||||Sign test|||||||0.2887
71784839|NCT02397785|143068778|SUPERIORITY|||||||0.9954|||||||Sign test|||||||0.9954
71784840|NCT02397785|143068779|SUPERIORITY|||||||0.0574|||||||Sign test|||||||0.0574
71784841|NCT02397785|143068780|SUPERIORITY|||||||0.7827|||||||Sign test|||||||0.7827
71784842|NCT02397785|143068781|SUPERIORITY|||||||0.2114|||||||Sign test|||||||0.2114
71784843|NCT02397785|143068782|SUPERIORITY|||||||0.4986|||||||Sign test|||||||0.4986
71784844|NCT02397785|143068783|SUPERIORITY|||||||0.461|||||||Sign test|||||||0.4610
71784845|NCT02397785|143068784|SUPERIORITY|||||||0.2556|||||||Sign test|||||||0.2556
71784846|NCT02397785|143068785|SUPERIORITY|||||||0.0723|||||||t-test, 2 sided|||||||0.0723
71784847|NCT02397785|143068786|SUPERIORITY|||||||0.7456|||||||t-test, 2 sided|||||||0.7456
71784848|NCT02397785|143068787|SUPERIORITY|||||||0.138|||||||t-test, 2 sided|||||||0.1380
71784849|NCT02397785|143068788|SUPERIORITY|||||||0.3155|||||||t-test, 2 sided|||||||0.3155
71784850|NCT02557646|143068792|SUPERIORITY_OR_OTHER|||||||0.0437|TWO_SIDED||||||Chi-squared|||Cumulative dose of ribavirin \>90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.||||0.0437
71784851|NCT02557646|143068794|SUPERIORITY_OR_OTHER|||||||0.6859|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.||||0.6859
71784852|NCT02557646|143068795|SUPERIORITY_OR_OTHER|||||||0.374|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.||||0.3740
71784853|NCT02557646|143068796|SUPERIORITY_OR_OTHER|||||||0.0263|TWO_SIDED||||||Chi-squared, Corrected|||The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.||||0.0263
71784854|NCT02557646|143068797|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.||||0.0475
71784855|NCT02557646|143068803|SUPERIORITY_OR_OTHER|||||||0.1499|TWO_SIDED||||||Chi-squared|||The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.1499
71784856|NCT02557646|143068804|SUPERIORITY_OR_OTHER|||||||0.5885|TWO_SIDED||||||Chi-squared|||The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.5885
71784857|NCT02557646|143068805|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.||||0.0062
71845412|NCT01478594|143205117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.615|2.501|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.501|0.615|
71784858|NCT00518986|143068807|SUPERIORITY_OR_OTHER|||||||0.3043||95.0|||||ANCOVA|Study drug was fixed factor and corresponding baseline value was a covariate.||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.3043
71784859|NCT00518986|143068808|SUPERIORITY_OR_OTHER|||||||0.012|||||||Chi-squared|P-value for comparison is from a Pearson's chi-square test||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were \<= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was \> 0.05and the other was \<=0.025, the variable with a p-value \<= 0.025 was claimed as significant.||||0.0120
71784860|NCT00518986|143068809|SUPERIORITY_OR_OTHER|||||||0.0027||||||Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.|ANCOVA|||Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.||||0.0027
71784861|NCT00518986|143068810|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
71784862|NCT00518986|143068811|SUPERIORITY_OR_OTHER|||||||0.3145|||||||ANCOVA|||||||0.3145
71784863|NCT00518986|143068812|SUPERIORITY_OR_OTHER|||||||0.2196|||||||ANCOVA|||||||0.2196
71896251|NCT02532543|143314619|SUPERIORITY|||||||0.999|||||||ANOVA|||Comparison between each arm/group of change in mid palatal bone height||||0.999
71784864|NCT00518986|143068813|SUPERIORITY_OR_OTHER|||||||0.2017||||||P-value is from Pearson's chi-square test|Chi-squared|||||||0.2017
71784865|NCT00518986|143068814|SUPERIORITY_OR_OTHER|||||||0.0032||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0032
71784866|NCT00518986|143068815|SUPERIORITY_OR_OTHER|||||||0.0207||||||P-value from Pearson's chi-square test|Chi-squared|||||||0.0207
71784867|NCT00518986|143068816|SUPERIORITY_OR_OTHER|||||||0.0529||||||P-value was generated from a Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel|||||||0.0529
71784868|NCT00518986|143068817|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
71784869|NCT00518986|143068818|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|||||||0.0064
71845413|NCT01478594|143205118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.343|2.63|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.630|0.343|
71784870|NCT00518986|143068819|SUPERIORITY_OR_OTHER|||||||0.1072|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1072
71896252|NCT02532543|143314619|SUPERIORITY|||||||0.44|||||||ANOVA|||Comparison between each arm/group of change in mesial bone height||||0.440
71784871|NCT00518986|143068820|SUPERIORITY_OR_OTHER|||||||0.0355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0355
71784872|NCT00518986|143068821|SUPERIORITY_OR_OTHER|||||||0.0591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0591
71784873|NCT00518986|143068822|SUPERIORITY_OR_OTHER|||||||0.0025|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0025
71784874|NCT00518986|143068823|SUPERIORITY_OR_OTHER|||||||0.0794||||||P-value for treatment comparison is from Pearson's chi-square test|Chi-squared|||||||0.0794
71784875|NCT00518986|143068824|SUPERIORITY_OR_OTHER|||||||0.0888||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||||||0.0888
71784876|NCT00518986|143068825|SUPERIORITY_OR_OTHER|||||||0.0433||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0433
71784877|NCT00518986|143068826|SUPERIORITY_OR_OTHER|||||||0.0105||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||||||0.0105
71784878|NCT00518986|143068827|SUPERIORITY_OR_OTHER|||||||0.0523|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0523
71784879|NCT00518986|143068828|SUPERIORITY_OR_OTHER|||||||0.0289|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0289
71784880|NCT00518986|143068829|SUPERIORITY_OR_OTHER|||||||0.1272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1272
71784881|NCT00518986|143068830|SUPERIORITY_OR_OTHER|||||||0.0349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0349
71784882|NCT00518986|143068831|SUPERIORITY_OR_OTHER|||||||0.0094|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0094
71896253|NCT02532543|143314619|SUPERIORITY|||||||0.729|||||||ANOVA|||Comparison between each arm/group of change in distal bone height||||0.729
71753055|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|3.6|||||TWO_SIDED|90.0|-30.5|37.3||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||37.3|-30.5|
71784883|NCT00518986|143068832|SUPERIORITY_OR_OTHER|||||||0.0754|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0754
71784884|NCT00518986|143068833|SUPERIORITY_OR_OTHER|||||||0.0105|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0105
71784885|NCT00518986|143068834|SUPERIORITY_OR_OTHER|||||||0.2888|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2888
71784886|NCT00518986|143068835|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0130
71784887|NCT00518986|143068836|SUPERIORITY_OR_OTHER|||||||0.0354|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0354
71784888|NCT00518986|143068837|SUPERIORITY_OR_OTHER|||||||0.3854||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7 after baseline||||0.3854
71784889|NCT00518986|143068838|SUPERIORITY_OR_OTHER|||||||0.0145||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders were defined as subjects with worst fatigue score \< 7||||0.0145
71784890|NCT00518986|143068839|SUPERIORITY_OR_OTHER|||||||0.6475||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders were patients with worst fatigue scores \< 7||||0.6475
71784891|NCT00518986|143068840|SUPERIORITY_OR_OTHER|||||||0.0118||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score \< 7||||0.0118
71784892|NCT00518986|143068841|SUPERIORITY_OR_OTHER|||||||0.3483||||||P-value for the treatment comparison is from the Pearson's chi-square test.|Chi-squared|||Responders are subjects with a worst fatigue score of \< 7||||0.3483
71784893|NCT00518986|143068842|SUPERIORITY_OR_OTHER|||||||0.0879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0879
71784894|NCT00518986|143068843|SUPERIORITY_OR_OTHER|||||||0.0277|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0277
71784895|NCT00518986|143068844|SUPERIORITY_OR_OTHER|||||||0.1245|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1245
71784896|NCT00518986|143068845|SUPERIORITY_OR_OTHER|||||||0.0305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0305
71784897|NCT00518986|143068846|SUPERIORITY_OR_OTHER|||||||0.0129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0129
71784898|NCT00518986|143068847|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0308
71784899|NCT00518986|143068848|SUPERIORITY_OR_OTHER|||||||0.0679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0679
71784900|NCT00518986|143068849|SUPERIORITY_OR_OTHER|||||||0.0153|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0153
71896254|NCT02532543|143314620|SUPERIORITY|||||||0.613|||||||ANOVA|||||||0.613
71896255|NCT02532543|143314621|SUPERIORITY|||||||0.492|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest||||0.492
71753056|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|13.6|||||TWO_SIDED|90.0|-21.9|46.2||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.||46.2|-21.9|
71753057|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|90.0|-33.2|34.6||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||34.6|-33.2|
71753058|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|20.5|||||TWO_SIDED|90.0|-17.6|51.9||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||51.9|-17.6|
71753059|NCT02201524|143008903|SUPERIORITY_OR_OTHER||Difference in Percentage|12.5|||||TWO_SIDED|90.0|-26.4|48.1||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.||48.1|-26.4|
71753060|NCT02546609|143008945|OTHER|||||||0.0572|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.0572
71753061|NCT02546609|143008945|OTHER|||||||0.377|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.||||0.3770
71753062|NCT02546609|143008946|OTHER|||||||0.3811|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3811
71753063|NCT02546609|143008946|OTHER|||||||0.8479|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8479
71753064|NCT02546609|143008947|OTHER|||||||0.7742|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.7742
71753065|NCT02546609|143008947|OTHER|||||||0.6666|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6666
71753066|NCT02546609|143008948|OTHER|||||||0.002|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0020
71753067|NCT02546609|143008948|OTHER|||||||0.0164|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0164
71753068|NCT02546609|143008949|OTHER|||||||0.4099|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4099
71753069|NCT02546609|143008949|OTHER|||||||0.1455|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.1455
71753070|NCT02546609|143008950|OTHER|||||||0.2559|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2559
71753071|NCT02546609|143008950|OTHER|||||||0.9776|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.9776
71753072|NCT02546609|143008951|OTHER|||||||0.2265|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.2265
71753073|NCT02546609|143008951|OTHER|||||||0.8366|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8366
71753074|NCT02546609|143008952|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
71753075|NCT02546609|143008952|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
71753076|NCT02546609|143008953|OTHER|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3470
71753077|NCT02546609|143008953|OTHER|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.6221
71753078|NCT02546609|143008954|OTHER|||||||0.0129|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.0129
71753079|NCT02546609|143008954|OTHER|||||||0.4316|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4316
71753080|NCT02546609|143008955|OTHER|MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||||0.1946|||||||MMRM|||||||0.1946
71753081|NCT02546609|143008955|OTHER|||||||0.4697|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.4697
71753082|NCT02546609|143008956|OTHER|||||||0.3474|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.3474
71753083|NCT02546609|143008956|OTHER|||||||0.8832|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||0.8832
71753084|NCT01553084|143008971|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3623|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|||Combination NRT will be compared statististically versus Nicotine patch only (the reference or control group).||1.7|0.8|.3623
71753085|NCT01553084|143008971|SUPERIORITY||Odds Ratio (OR)|0.9||||0.1947|TWO_SIDED|95.0|0.6|1.2|||Regression, Logistic|||Varenicline will be compared statististically versus Nicotine patch only (the reference or control group).||1.2|0.6|.1947
71753086|NCT01553084|143008972|SUPERIORITY||Hazard Ratio (HR)|0.915||||0.3613|TWO_SIDED|95.0|0.756|1.107|||Regression, Cox|||||1.107|.756|.3613
71753087|NCT01553084|143008972|SUPERIORITY||Hazard Ratio (HR)|0.943||||0.5503|TWO_SIDED|95.0|0.779|1.142|||Regression, Cox|||||1.142|.779|.5503
71753088|NCT01553084|143008973|SUPERIORITY||Odds Ratio (OR)|1.5||||0.03|TWO_SIDED|95.0|1.1|2.2|||Regression, Logistic|||||2.2|1.1|.03
71753089|NCT01553084|143008973|SUPERIORITY||Odds Ratio (OR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Logistic|||||1.1|0.6|.19
71891862|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.27|||||TWO_SIDED|95.0|0.11|0.42||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.42|0.11|
71891863|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.17|||||TWO_SIDED|95.0|0.1|0.23||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.23|0.10|
71891864|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.05|||||TWO_SIDED|95.0|-0.03|0.13||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.13|-0.03|
71753090|NCT01553084|143008974|SUPERIORITY||Mean Difference (Final Values)|-0.00612|STANDARD_ERROR_OF_MEAN|0.00625||0.3282|TWO_SIDED||||||t-test, 2 sided|df=710||||||.3282
71753091|NCT03988400|143008975|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
71753092|NCT03988400|143008976|SUPERIORITY|||||||0.017||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.017
71753093|NCT03988400|143008977|SUPERIORITY|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1
71753094|NCT03988400|143008978|SUPERIORITY|||||||0.72||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.72
71753095|NCT03988400|143008979|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.001
71784901|NCT00518986|143068850|SUPERIORITY_OR_OTHER|||||||0.0296|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0296
71753096|NCT03988400|143008980|SUPERIORITY|||||||0.68||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||||0.68
71784902|NCT00518986|143068851|SUPERIORITY_OR_OTHER|||||||0.0107|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0107
71753097|NCT03988400|143008981|SUPERIORITY|||||||0.25||||||The a priori threshold for statistical significance was 0.05|t-test, 2 sided|||||||0.25
71753098|NCT03988400|143008982|SUPERIORITY|||||||0.69||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.69
71753099|NCT03988400|143008983|SUPERIORITY|||||||0.2||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.20
71753100|NCT03988400|143008984|SUPERIORITY|||||||0.62||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.62
71753101|NCT04201431|143008990|OTHER|Comparison of pooled data from Groups 1 and 2 volunteers who completed primary CHMI with pooled data of infectivity controls undergoing primary CHMI from VAC069 study running in parallel (NCT03797989).||||||0.01||||||Two tailed p value reported for Mann-Whitney test comparing infectivity controls with vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of parasite multiplication rate in vaccinated subjects compared to infectivity controls in a blood-stage controlled human malaria infection model||||0.01
71753102|NCT03164668|143009025|SUPERIORITY||Estimated mean ratio|0.31|||||TWO_SIDED|95.0|0.13|0.72|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||0.72|0.13|
71753103|NCT03164668|143009025|SUPERIORITY||Estimated mean ratio|0.98|||||TWO_SIDED|95.0|0.78|1.22|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||1.22|0.78|
71753104|NCT03164668|143009026|SUPERIORITY||Estimated mean ratio|3.03|||||TWO_SIDED|95.0|1.39|6.61|||||Model estimated mean ratio in puffs of e-cigarettes used per day among those randomized to conditions in which menthol cigarettes are avoided relative to conditions in which participants can continue smoking usual cigarettes|Comparison of those assigned to conditions in which menthol cigarettes are avoided relative to conditions in which can continue smoking usual cigarettes||6.61|1.39|
71753105|NCT03164668|143009026|SUPERIORITY||Estimated mean ratio|0.74|||||TWO_SIDED|95.0|0.59|0.92|||||Estimated mean ratio of number of puffs of e-cigarettes used per day among those in conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes|Comparison of those assigned to conditions in which they receive tobacco flavored e-cigarettes relative to conditions in which they receive menthol flavored e-cigarettes||0.92|0.59|
71753106|NCT00168844|143009046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
71753107|NCT00168844|143009046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
71784903|NCT00518986|143068852|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as patients with a total score on FOSQ \> 17.9||||0.0100
71669410|NCT04910100|142855832|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|9.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71784904|NCT00518986|143068853|SUPERIORITY_OR_OTHER|||||||0.0854||95.0||||P-value for treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score of \> 17.9||||0.0854
71784905|NCT00518986|143068854|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score \> 17.9||||0.0027
71784906|NCT00518986|143068855|SUPERIORITY_OR_OTHER|||||||0.0189||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||Responders are defined as subjects who had a total score of \> 17.9||||0.0189
71784907|NCT00518986|143068856|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with total score \> 17.9||||0.0240
71784908|NCT00518986|143068857|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3320
71784909|NCT00518986|143068858|SUPERIORITY_OR_OTHER|||||||0.893||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8930
71784910|NCT00518986|143068859|SUPERIORITY_OR_OTHER|||||||0.1774||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1774
71784911|NCT00518986|143068860|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1000
71784912|NCT00518986|143068861|SUPERIORITY_OR_OTHER|||||||0.2428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2428
71784913|NCT00518986|143068862|SUPERIORITY_OR_OTHER|||||||0.1816||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1816
71784914|NCT00518986|143068863|SUPERIORITY_OR_OTHER|||||||0.1627||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1627
71784915|NCT00518986|143068864|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0018
71784916|NCT00518986|143068865|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
71836344|NCT02596126|143178392|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.8|||<|0.05|TWO_SIDED|95.0|-0.1|1.6||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 12 months||1.6|-0.1|< 0.05
71784917|NCT00518986|143068866|SUPERIORITY_OR_OTHER|||||||0.0126||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0126
71784918|NCT03366337|143068942|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|9.31|STANDARD_ERROR_OF_MEAN|1.3743|<|0.0001|TWO_SIDED|95.0|6.5|12.13|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.13|6.5|<0.0001
71784919|NCT03366337|143068942|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|8.0|STANDARD_ERROR_OF_MEAN|1.57|<|0.0001|TWO_SIDED|95.0|4.75|11.25|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||11.25|4.75|<0.0001
71784920|NCT03366337|143068942|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|5.46|STANDARD_ERROR_OF_MEAN|2.2792||0.0247|TWO_SIDED|95.0|0.76|10.16|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||10.16|0.76|0.0247
71784921|NCT03366337|143068942|SUPERIORITY|A formal test of mean change from baseline in eGFR ≠ 0 was conducted at Week 12.|LS Mean change from baseline|7.83|STANDARD_ERROR_OF_MEAN|2.216||0.003|TWO_SIDED|95.0|3.11|12.55|||Mixed Models Analysis|Available data from analysis visits Week 1 to Week 12 were included. Missing data were not imputed.||||12.55|3.11|0.0030
71669411|NCT04910100|142855832|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71669412|NCT04910100|142855832|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71669413|NCT04910100|142855832|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.5 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71669414|NCT04910100|142855832|NON_INFERIORITY|To demonstrate noninferiority, the upper limits of the 2-sided 95% confidence interval for the difference between each comparison must be lower than 1.5 mmHg at all timepoints and lower than 1.0 mmHg for the majority of the timepoints (i.e. at least 5 of 9). This was a Phase 2 study and so the sample size was not based on a formal sample size calculation. The study was planned to provide sufficient data to power a Phase 3 study.|Timepoints with Mean IOP < 1.0 mm Hg|0.0|||||TWO_SIDED|||||||||The primary efficacy analysis was the between group comparison of the mean IOP values in the study eye at each time point at each visit (a total of 9 between-group comparisons). A hierarchical analysis was conducted to compare each of the investigational products against the comparator, timolol 0.5% as follows: (1) Timolol Suspensions 0.5% (2) Nebivolol Suspension 1% (3) Nebivolol Suspension 0.5%.||||
71669415|NCT07034820|142855839|SUPERIORITY||Risk Difference (RD)|56.0|||<|0.001|TWO_SIDED|95.0|48.0|64.0||A priori statistical significance threshold for the primary endpoint was set at a two-sided alpha level of 0.05. No adjustment for multiple comparisons was applied to the primary outcome analysis, as it was the sole primary endpoint.|Chi-squared||The Risk Difference (RD) indicates the absolute difference in hemorrhoid regression rates between the Nimsai Herbal Group and the Placebo Group. Calculation: Nimsai Herbal (78%) - Placebo (22%) = 56%.|Powered for 56% difference (80% power, alpha=0.05) to detect the anticipated difference in hemorrhoid regression rates between groups. The sample size of N=300 (150 participants per arm) was calculated based on an expected regression rate of 22% in the placebo group and 78% in the Nimsai Herbal group. This ensured sufficient statistical power for the primary efficacy analysis.||64|48|<0.001
71669416|NCT02845700|142855840|SUPERIORITY|||||||0.08|||||||ANOVA|2 (time) x 2 (group) x 5 (dilution %) repeated measures ANOVA||||||.08
71845414|NCT01478594|143205118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.983|||||TWO_SIDED|95.0|0.503|1.918|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.918|0.503|
71669417|NCT02845700|142855841|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|t(4) = -1.19, p = .39||Post-hoc estimates of observed power for the difference between group means was calculated to be .15.||||.39
71669418|NCT02845700|142855844|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|t(4) = 0.66, p = .54||Post-hoc estimates of observed power for the difference between group means was calculated to be .08.||||.54
71753108|NCT00168844|143009047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.269|STANDARD_ERROR_OF_MEAN|0.996||0.0011||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||0.0011
71753109|NCT00168844|143009047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.242|STANDARD_ERROR_OF_MEAN|0.999|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|||||<0.0001
71753110|NCT00168844|143009048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.053|STANDARD_ERROR_OF_MEAN|0.165|<|0.0001|TWO_SIDED|95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|||||<0.0001
71753111|NCT00168844|143009048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.075|STANDARD_ERROR_OF_MEAN|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.||||||<0.0001
71753112|NCT00168844|143009049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.782||||0.0002|TWO_SIDED|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg - Placebo|||0.890|0.687|0.0002
71753113|NCT00168844|143009049|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.725|||<|0.0001|TWO_SIDED|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg - Placebo|||0.828|0.635|<0.0001
71753114|NCT00168844|143009093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71753115|NCT00168844|143009093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71784922|NCT00534430|143069037|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Log Rank|No adjustments.||Log-rank test. (Mantel-Haenszel test). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing.||||>0.05
71784923|NCT00534430|143069038|EQUIVALENCE|Given the small sample-size of the disease sub-groups, this was a hypothesis generating study.|Median Difference (Net)|0.0|||>|0.05|TWO_SIDED|||||Not adjusted for multiple comparisons. A-priori threshold for statistical significance was 0.05.|Gray's Test|No adjustments.||Gray's estimate. (Fine and Gray). Null hypothesis is all four groups are statistically from the same population. Alternative hypothesis is that at least one of the groups is from a population different from the remaining groups. Anticipated sample-sizes comparing Active ALL (anticipated N= 12) with the combined AML patients (anticipated N=38) was deemed to be too small for formal hypothesis testing||||>0.05
71784924|NCT02324569|143069059|SUPERIORITY||Least square (LS) mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.826|-0.443|||ANCOVA|||||-0.443|-0.826|<0.0001
71784925|NCT00911820|143069074|SUPERIORITY|||||||0.714|||||||Log Rank|||||||0.714
71784926|NCT00911820|143069076|SUPERIORITY|||||||0.605|||||||Fisher Exact|||||||0.605
71784927|NCT00911820|143069077|SUPERIORITY|||||||0.721|||||||Log Rank|||||||0.721
71784928|NCT00759031|143069133|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71896256|NCT02532543|143314621|SUPERIORITY|||||||0.917|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest||||0.917
71784929|NCT00309387|143069136|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.03|TWO_SIDED|95.0|0.68|0.98|||Regression, Cox|||||0.98|0.68|0.03
71784930|NCT00616200|143069144|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Sickness Impact Profile scores improved.||||.001
71784931|NCT02483520|143069146|SUPERIORITY||LSM Estimate|0.03||||0.977|TWO_SIDED|95.0|-2.02|2.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||2.08|-2.02|.977
71784932|NCT02483520|143069147|SUPERIORITY||LSM Estimate|-0.22||||0.812|TWO_SIDED|95.0|-2.09|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-2.09|.812
71784933|NCT02483520|143069150|SUPERIORITY||LSM Estimate|-1.5||||0.343|TWO_SIDED|95.0|-4.64|1.64|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.64|-4.64|.343
71784934|NCT02483520|143069151|SUPERIORITY||LSM Estimate|-4.79||||0.012|TWO_SIDED|95.0|-8.51|-1.08|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||-1.08|-8.51|.012
71784935|NCT02483520|143069152|SUPERIORITY||LSM Estimate|0.77||||0.033|TWO_SIDED|95.0|0.07|1.47|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||1.47|0.07|.033
71784936|NCT02483520|143069155|SUPERIORITY|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.211
71784937|NCT02483520|143069155|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||<.001
71784938|NCT02483520|143069156|SUPERIORITY|||||||0.476|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.476
71784939|NCT02483520|143069156|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.005
71784940|NCT02483520|143069157|SUPERIORITY|||||||0.677|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for differences between mean group changes using Wilcoxon rank-sum test at 3 months||||.677
71784941|NCT02483520|143069157|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||p-values were calculated for within- group changes using Wilcoxon signed-rank test between baseline and 3 months||||.020
71784942|NCT02483520|143069158|SUPERIORITY||LSM Estimate|-0.62||||0.432|TWO_SIDED|95.0|-2.18|0.94|||Mixed Models Analysis|||Linear mixed models were fitted to changes in outcomes with SAS Procedure Mixed. Efficacy of the FamTechCare intervention versus attention control was expressed as the model-estimated difference between the groups on mean change from baseline to 3 months. Burden, Depression, Sleep disturbance, Competence, Desire to institutionalize, Reaction to memory symptoms, Reaction to depression symptoms, Reaction to disruptive symptoms were included in the model.||0.94|-2.18|.432
71784943|NCT02483520|143069159|SUPERIORITY|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||||||.255
71784944|NCT04492618|143069165|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71784945|NCT03462082|143069191|SUPERIORITY|||||||0.163||||||"Holm-adjusted P-Value: 0.326~\*Gait Velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.163
71784946|NCT03462082|143069191|SUPERIORITY|||||||0.749||||||"Holm-adjusted P-Value: 0.749~\*Gait Velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.749
71784947|NCT03462082|143069192|SUPERIORITY|||||||0.031||||||"Holm-adjusted P-Value: 0.155~\*MDS-UPDRS (total) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.031
71784948|NCT03462082|143069192|SUPERIORITY|||||||0.778||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS total for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to report the changes associated with the 2 asymmetric conditions.||||0.778
71784949|NCT03462082|143069192|SUPERIORITY|||||||0.039||||||"Holm-adjusted P-Value: 0.157~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.039
71784950|NCT03462082|143069192|SUPERIORITY|||||||0.451||||||"Holm-adjusted P-Value: 0.902~\*MDS-UPDRS (motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.451
71784951|NCT03462082|143069192|SUPERIORITY|||||||0.111||||||"Holm-adjusted P-Value: 0.333~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.111
71784952|NCT03462082|143069192|SUPERIORITY|||||||0.005||||||"Holm-adjusted P-Value: 0.030~\*MDS-UPDRS (axial motor) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.005
71784953|NCT03462082|143069193|SUPERIORITY|||||||0.984||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.984
71784954|NCT03462082|143069193|SUPERIORITY|||||||0.067||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.067
71784955|NCT03462082|143069194|SUPERIORITY|||||||0.44||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.440
71784956|NCT03462082|143069194|SUPERIORITY|||||||0.051||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.051
71784957|NCT03462082|143069195|SUPERIORITY|||||||0.945||||||Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.945
71784958|NCT03462082|143069195|SUPERIORITY|||||||0.024||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.024
71784959|NCT03462082|143069196|SUPERIORITY|||||||0.097||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.097
71845415|NCT01478594|143205119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.226|||||TWO_SIDED|95.0|0.468|3.214|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.214|0.468|
71669419|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.93|TWO_SIDED|95.0|-0.4|0.44|||Mixed model for repeated measurements|||"Day 1, 30 min post dose.~SpO2/FiO2 and FiO2 (%) over the first 24 hours: analyzed using a linear mixed model for repeated measures (MMRM) including treatment, timepoint, treatment by timepoint interaction, investigational site and gestational age (GA) group as fixed effects, and predose values as covariates. The adjusted mean difference between treatments, and their 95% confidence intervals (CIs) at each timepoint and averaged over the first 24 hours were estimated by the model."||0.44|-0.40|0.930
71669420|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.346|TWO_SIDED|95.0|-0.59|0.21|||Mixed model for repeated measurements|||Day 1, 1 h post dose||0.21|-0.59|0.346
71753116|NCT00168844|143009094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71753117|NCT00168844|143009094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71753118|NCT00168844|143009095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71753119|NCT00168844|143009095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.419|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71753120|NCT00168844|143009096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71753121|NCT00168844|143009096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71753122|NCT00168844|143009097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71753123|NCT00168844|143009097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71753124|NCT00168844|143009098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48||||<0.0001
71753125|NCT00168844|143009098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48||||<0.0001
71836345|NCT02596126|143178393|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.9|1.0||The difference in mean change from baseline between groups will be compared using ANCOVA (adjusting for baseline levels) at 6 months, 12 months and 24 months. The difference in mean change adjusting for baseline and 95% CI will be reported.|ANCOVA|||Statistical analysis title - DBP - 24 months||1|-0.9|< 0.05
71845416|NCT01478594|143205119|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232|||||TWO_SIDED|95.0|0.447|3.396|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.396|0.447|
71896257|NCT02532543|143314622|SUPERIORITY|||||||0.353|||||||ANOVA|||Comparison between each arm/group of change in mid buccal soft tissue height||||0.353
71753126|NCT01377584|143009104|OTHER||Effect size|-0.51|||||TWO_SIDED|||||||||||||
71753127|NCT01377584|143009104|OTHER||Effect size|-0.42|||||TWO_SIDED|||||||||||||
71753128|NCT01377584|143009104|OTHER||Effect size|-0.82|||||TWO_SIDED|||||||||||||
71753129|NCT01377584|143009104|OTHER||Effect size|-1.31|||||TWO_SIDED|||||||||||||
71753130|NCT01377584|143009104|OTHER||Effect size|-0.08|||||TWO_SIDED|||||||||||||
71753131|NCT01377584|143009104|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
71753132|NCT01377584|143009105|OTHER||Effect size|0.51|||||TWO_SIDED|||||||||||||
71753133|NCT01377584|143009105|OTHER||Effect size|0.41|||||TWO_SIDED|||||||||||||
71753134|NCT01377584|143009105|OTHER||Effect size|0.57|||||TWO_SIDED|||||||||||||
71753135|NCT01377584|143009105|OTHER||Effect size|1.54|||||TWO_SIDED|||||||||||||
71753136|NCT01377584|143009105|OTHER||Effect size|0.0|||||TWO_SIDED|||||||||||||
71753137|NCT01377584|143009105|OTHER||Effect size|0.65|||||TWO_SIDED|||||||||||||
71753138|NCT01377584|143009106|OTHER||Effect size|-1.01|||||TWO_SIDED|||||||||||||
71753139|NCT01377584|143009106|OTHER||Effect size|-0.94|||||TWO_SIDED|||||||||||||
71753140|NCT01377584|143009106|OTHER||Effect size|-0.4|||||TWO_SIDED|||||||||||||
71753141|NCT01377584|143009106|OTHER||Effect size|-0.31|||||TWO_SIDED|||||||||||||
71753142|NCT01377584|143009106|OTHER||Effect size|-0.65|||||TWO_SIDED|||||||||||||
71753143|NCT01377584|143009106|OTHER||Effect size|-0.77|||||TWO_SIDED|||||||||||||
71753144|NCT01377584|143009107|OTHER||Effect size|0.52|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
71753145|NCT01377584|143009107|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month and 3 months|||||
71753146|NCT01377584|143009107|OTHER||Effect size|0.5|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
71753147|NCT01377584|143009107|OTHER||Effect size|-0.63|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
71753148|NCT01377584|143009107|OTHER||Effect size|-0.92|||||TWO_SIDED||||||||Comparing 1 week to 1 month|||||
71753149|NCT01377584|143009107|OTHER||Effect size|-0.26|||||TWO_SIDED||||||||Comparing 1 month to 3 months|||||
71669421|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.549|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 3 h post dose||0.23|-0.43|0.549
71784960|NCT03462082|143069196|SUPERIORITY|||||||0.75||||||"Holm-adjusted P-Value: 1.00~\*Gait velocity for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.750
71784961|NCT03462082|143069197|SUPERIORITY|||||||0.128||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.128
71784962|NCT03462082|143069197|SUPERIORITY|||||||0.117||||||"Holm-adjusted P-Value: 1.00~\*Step length (mean) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.117
71784963|NCT03462082|143069197|SUPERIORITY|||||||0.145||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.145
71784964|NCT03462082|143069197|SUPERIORITY|||||||0.056||||||"Holm-adjusted P-Value: 1.00~\*Step length (right) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.056
71784965|NCT03462082|143069197|SUPERIORITY|||||||0.151||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.151
71836346|NCT02596126|143178394|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|2.1|||<|0.05|TWO_SIDED|95.0|-0.2|4.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 12 months||4.4|-0.2|< 0.05
71669422|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.539|TWO_SIDED|95.0|-0.43|0.23|||Mixed model for repeated measurements|||Day 1, 6 h post dose||0.23|-0.43|0.539
71784966|NCT03462082|143069197|SUPERIORITY|||||||0.129||||||"Holm-adjusted P-Value: 1.00~\*Step length (left) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.129
71784967|NCT03462082|143069197|SUPERIORITY|||||||0.698||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.698
71784968|NCT03462082|143069197|SUPERIORITY|||||||0.779||||||"Holm-adjusted P-Value: 1.00~\*Step length difference for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.779
71784969|NCT03462082|143069198|SUPERIORITY|||||||0.874||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.874
71784970|NCT03462082|143069198|SUPERIORITY|||||||0.976||||||"Holm-adjusted P-Value: 1.00~\*Step length ratio for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.976
71836347|NCT02596126|143178395|EQUIVALENCE|The following three CV risk factors, systolic blood pressure(SBP), diastolic blood pressure (DBP) and low-density lipoprotein (LDL) cholesterol levels are measured at baseline, visit 1 (6 months), visit 2 (12 months) and visit 3 (24 months).For each of the three risk factors the frequency, mean and standard deviation at each visit will be reported by treatment group. The difference in mean change from baseline between groups will be compared using ANCOVA.|Mean Difference (Final Values)|-0.1|||<|0.05|TWO_SIDED|95.0|-2.5|2.4|||ANCOVA|||Statistical analysis title - LDL cholesterol - 24 months||2.4|-2.5|< 0.05
71669423|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.491|TWO_SIDED|95.0|-0.21|0.43|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.43|-0.21|0.491
71669424|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.623|TWO_SIDED|95.0|-0.22|0.37|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.37|-0.22|0.623
71669425|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.608|TWO_SIDED|95.0|-0.25|0.43|||Mixed model for repeated measurements|||Day 1, 24 h post dose||0.43|-0.25|0.608
71836348|NCT02596126|143178396|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.54|0.9|||Regression, Cox|||||0.90|0.54|< 0.025
71836349|NCT02596126|143178396|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71836350|NCT02596126|143178397|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.67|||<|0.025|TWO_SIDED|95.0|0.47|0.97|||Regression, Cox|||||0.97|0.47|< 0.025
71836351|NCT02596126|143178397|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71836352|NCT02596126|143178398|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.71|||<|0.025|TWO_SIDED|95.0|0.48|1.05|||Regression, Cox|||||1.05|0.48|< 0.025
71836353|NCT02596126|143178398|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71836354|NCT02596126|143178399|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.7|||<|0.025|TWO_SIDED|95.0|0.39|1.26|||Regression, Cox|||||1.26|0.39|< 0.025
71836355|NCT02596126|143178399|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71836356|NCT02596126|143178400|NON_INFERIORITY|"Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country.~One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%.~All statistical analyses will use 95% confidence intervals (CI).If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test."|Hazard Ratio (HR)|0.96|||<|0.025|TWO_SIDED|95.0|0.57|1.63|||Regression, Cox|||||1.63|0.57|< 0.025
71836357|NCT02596126|143178400|SUPERIORITY|If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a logrank test.|||||<|0.05|||||||Log Rank|||||||< 0.05
71669426|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.869|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||0.30|-0.35|0.869
71669427|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.833|TWO_SIDED|95.0|-0.38|0.31|||Mixed Models Analysis|||Day 3, post dose||0.31|-0.38|0.833
71836358|NCT02596126|143178401|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.09|||<|0.05|TWO_SIDED|95.0|1.38|4.79|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||4.79|1.38|< 0.05
71836359|NCT02596126|143178402|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|-5.19|||<|0.05|TWO_SIDED|95.0|-12.73|2.35|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||2.35|-12.73|< 0.05
71845417|NCT01478594|143205120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.803|||||TWO_SIDED|95.0|0.307|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.100|0.307|
71669428|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.772|TWO_SIDED|95.0|-0.39|0.29|||Mixed Models Analysis|||Day 5, post dose||0.29|-0.39|0.772
71669429|NCT02452476|142855845|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.963|TWO_SIDED|95.0|-0.33|0.35|||Mixed Models Analysis|||Day 7, post dose||0.35|-0.33|0.963
71669430|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.519|TWO_SIDED|95.0|-7.87|3.99|||Mixed model for repeated measurements|||Day 1, 30 min post dose||3.99|-7.87|0.519
71669431|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|2.45||||0.282|TWO_SIDED|95.0|-2.04|6.93|||Mixed model for repeated measurements|||Day 1, 1 h post dose||6.93|-2.04|0.282
71836360|NCT02596126|143178403|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.09|||<|0.05|TWO_SIDED|95.0|5.57|8.62|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.62|5.57|< 0.05
71784971|NCT03462082|143069198|SUPERIORITY|||||||0.859||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.859
71784972|NCT03462082|143069198|SUPERIORITY|||||||0.86||||||"Holm-adjusted P-Value: 1.00~\*Step length symmetry for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.860
71753150|NCT00310765|143009125|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measure analysis of variance modeling was used to evaluate whether the two study groups differed regarding the pain score change that occurred across each of the two study phases (weeks 0-7 and weeks 7-10). To conform to the analysis of variance assumption of distributional normality, the pain scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on exact rates from reference articles cited in the paper. Patients were randomly assigned to active drug (pregabalin) or look alike placebo.||4.0|0.0|<0.05
71753151|NCT00310765|143009126|SUPERIORITY_OR_OTHER_LEGACY|The group-by-time interaction result from repeated-measures analysis of variance modeling was used to evaluate whether the two study groups differed regarding the sleep score change that occurred during the two study phases (weeks 0-7 and weeks 7-11. to conform to the analysis of variance assumption of distributional normality the sleep scores were square root transformed before the analysis.|Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.5|<|0.05|TWO_SIDED|95.0|0.0|4.0|||ANOVA|||The number of patients required per treatment group to achieve a \>80% power with an alpha=0.05 were based on the exact rates from the reference articles cited in the paper.||4.0|0.0|<0.05
71753152|NCT01247324|143009143|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.536|||<|0.0001|TWO_SIDED|95.0|0.4|0.719|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.719|0.4|<0.0001
71753153|NCT01247324|143009144|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0139|TWO_SIDED|95.0|0.37|0.9|||Log Rank|||Time to onset CDP at week 12||0.90|0.37|= 0.0139
71753154|NCT01247324|143009145|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.058|||<|0.0001||95.0|0.032|0.104|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.104|0.032|< 0.0001
71753155|NCT01247324|143009146|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.229|||<|0.0001||95.0|0.174|0.3|||Negative Binomial Model||Adjusted by baseline T2 lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.300|0.174|< 0.0001
71753156|NCT01247324|143009147|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.61|||=|0.0106|TWO_SIDED|95.0|1.11|2.33|||CMH Chi-Squared test (stratified)|CMH (Cochran-Mantel-Haenszel) Chi-Squared test Stratified by Geographical Region (US vs. Rest of World) and Baseline EDSS (\<4.0 vs. \>=4.0)||||2.33|1.11|= 0.0106
71753157|NCT01247324|143009148|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||=|0.0278|TWO_SIDED|95.0|0.34|0.95|||Log Rank|||Time to onset CDP at week 24||0.95|0.34|= 0.0278
71753158|NCT01247324|143009149|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.428|||<|0.0001||95.0|0.328|0.557|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.557|0.328|< 0.0001
71753159|NCT01247324|143009150|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.039|STANDARD_ERROR_OF_MEAN|0.039|=|0.3261|TWO_SIDED|95.0|-0.039|0.116|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.116|-0.039|= 0.3261
71753160|NCT01247324|143009151|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.168|STANDARD_ERROR_OF_MEAN|0.058|=|0.0042|TWO_SIDED|95.0|0.053|0.283|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 22.8%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.283|0.053|= 0.0042
71753161|NCT01247324|143009152|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.693|STANDARD_ERROR_OF_MEAN|0.564|=|0.2193|TWO_SIDED|95.0|-0.414|1.8|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||1.800|-0.414|= 0.2193
71784973|NCT03462082|143069199|SUPERIORITY|||||||0.04||||||"Holm-adjusted P-Value: 0.480~\*Pitch (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.040
71836361|NCT02596126|143178404|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|3.79|||<|0.05|TWO_SIDED|95.0|2.04|5.55|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||5.55|2.04|< 0.05
71753162|NCT01247324|143009153|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.74|||<|0.0001|TWO_SIDED|95.0|1.39|2.17|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.17|1.39|< 0.0001
71753163|NCT00844844|143009201|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols:C08-002A (adult) and C08-002B (Adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
71753164|NCT00844844|143009202|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
71784974|NCT03462082|143069199|SUPERIORITY|||||||0.883||||||"Holm-adjusted P-Value: 1.00~\*Pitch (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.883
71784975|NCT03462082|143069199|SUPERIORITY|||||||0.071||||||"Holm-adjusted P-Value: 0.781~\*Pitch (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.071
71784976|NCT03462082|143069199|SUPERIORITY|||||||0.327||||||"Holm-adjusted P-Value: 1.00~\*Pitch (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.327
71784977|NCT03462082|143069200|SUPERIORITY|||||||0.487||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.487
71784978|NCT03462082|143069200|SUPERIORITY|||||||0.861||||||"Holm-adjusted P-Value: 1.00~\*Loudness (minimum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.861
71891865|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.08|0.19||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.19|0.08|
71669432|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.854|TWO_SIDED|95.0|-4.04|4.86|||Mixed model for repeated measurements|||Day 1, 3 h post dose||4.86|-4.04|0.854
71784979|NCT03462082|143069200|SUPERIORITY|||||||0.411||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.411
71784980|NCT03462082|143069200|SUPERIORITY|||||||0.997||||||"Holm-adjusted P-Value: 1.00~\*Loudness (maximum) for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.997
71784981|NCT03462082|143069201|SUPERIORITY|||||||0.388||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.388
71784982|NCT03462082|143069201|SUPERIORITY|||||||0.684||||||"Holm-adjusted P-Value: 1.00~\*Jitter for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.684
71669433|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.861|TWO_SIDED|95.0|-5.0|4.19|||Mixed model for repeated measurements|||Day 1, 6 h post dose||4.19|-5.00|0.861
71669434|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.117|TWO_SIDED|95.0|-6.24|0.7|||Mixed model for repeated measurements|||Day 1, 12 h post dose||0.70|-6.24|0.117
71753165|NCT00844844|143009203|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
71753166|NCT00844844|143009204|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
71753167|NCT00844844|143009205|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
71753168|NCT00844844|143009206|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline was analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
71753169|NCT00844844|143009207|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
71753170|NCT00844844|143009208|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
71753171|NCT00844844|143009209|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
71753172|NCT00844844|143009210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
71753173|NCT03593044|143009243|OTHER|||||||0.002|||||||t-test, 2 sided|||Photopic pupil size||||0.002
71753174|NCT03593044|143009243|OTHER|||||||0.66|||||||t-test, 2 sided|||Mesopic pupil size||||0.66
71753175|NCT03593044|143009244|OTHER|||||||0.96|||||||t-test, 2 sided|||High contrast distance visual acuity||||0.96
71753176|NCT03593044|143009244|OTHER|||||||0.77|||||||t-test, 2 sided|||High contrast near visual acuity||||0.77
71753177|NCT03593044|143009244|OTHER|||||||0.82|||||||t-test, 2 sided|||Low contrast distance visual acuity||||0.82
71753178|NCT03593044|143009245|OTHER|||||||0.1|||||||t-test, 2 sided|||Accommodative amplitude||||0.10
71753179|NCT03593044|143009245|OTHER|||||||0.66|||||||t-test, 2 sided|||Accommodative lag||||0.66
71753180|NCT03593044|143009245|OTHER|||||||0.24|||||||t-test, 2 sided|||Accommodative facility||||0.24
71753181|NCT03593044|143009246|OTHER|||||||0.3|||||||t-test, 2 sided|||Glare||||0.3
71753182|NCT03593044|143009246|OTHER|||||||0.5|||||||t-test, 2 sided|||Ghost images||||0.5
71753183|NCT03593044|143009246|OTHER|||||||0.9|||||||t-test, 2 sided|||Strain/tiredness||||0.9
71753184|NCT03593044|143009246|OTHER|||||||0.9|||||||t-test, 2 sided|||Changing vision||||0.9
71753185|NCT03593044|143009246|OTHER|||||||0.3|||||||t-test, 2 sided|||Headache frequency||||0.3
71753186|NCT03593044|143009246|OTHER|||||||0.7|||||||t-test, 2 sided|||Distance clarity||||0.7
71753187|NCT03593044|143009246|OTHER|||||||0.3|||||||t-test, 2 sided|||Computer clarity||||0.3
71753188|NCT03593044|143009246|OTHER|||||||0.1|||||||t-test, 2 sided|||Small print clarity||||0.1
71753189|NCT03593044|143009246|OTHER|||||||1|||||||t-test, 2 sided|||Vision during sports/hobbies||||1.0
71753190|NCT03593044|143009246|OTHER|||||||0.2|||||||t-test, 2 sided|||Overall vision||||0.2
71669435|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.185|TWO_SIDED|95.0|-4.79|0.94|||Mixed model for repeated measurements|||Day 1, 18 h post dose||0.94|-4.79|0.185
71669436|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.678|TWO_SIDED|95.0|-5.82|3.8|||Mixed model for repeated measurements|||Day 1, 24 h post dose||3.80|-5.82|0.678
71753191|NCT03593044|143009246|OTHER|||||||0.7|||||||t-test, 2 sided|||Light sensitivity||||0.7
71753192|NCT03593044|143009246|OTHER|||||||0.002|||||||t-test, 2 sided|||Discomfort during bright light||||0.002
71753193|NCT03593044|143009247|OTHER|||||||0.001|||||||t-test, 2 sided|||Right eye intraocular pressure||||0.001
71753194|NCT03593044|143009247|OTHER|||||||0.05|||||||t-test, 2 sided|||Left eye intraocular pressure||||0.05
71753195|NCT03577275|143009249|OTHER|||||||||||||||||"The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.~Assay sensitivity was evaluated by concentration-QTc analysis of the effect on delta delta QTcF of moxifloxacin using a similar model as for the primary analysis."|The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect \> 10 msec at clinically relevant icosabutate plasma concentrations.|||
71753196|NCT03270436|143009280|SUPERIORITY|||||||0.3599||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3599
71753197|NCT03270436|143009280|SUPERIORITY|||||||0.3207||||||The p-value above reflects results of between-arms analysis of change in mean weight from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3207
71669437|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.961|TWO_SIDED|95.0|-3.49|3.67|||Mixed Models Analysis|||"Day 2, post dose~SpO2/FiO2 was compared between treatments at the remaining post-treatment time points (i.e., Days 2, 3, 5, 7): analyzed using mixed model including treatment, investigational site and gestational age group as fixed effects and pre-dose ratio as covariate."||3.67|-3.49|0.961
71669438|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.544|TWO_SIDED|95.0|-6.53|3.46|||Mixed Models Analysis|||Day 3, post dose||3.46|-6.53|0.544
71669439|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|1.74||||0.492|TWO_SIDED|95.0|-3.28|6.76|||Mixed Models Analysis|||Day 5, post dose||6.76|-3.28|0.492
71753198|NCT03270436|143009281|SUPERIORITY|||||||0.5698||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5698
71753199|NCT03270436|143009281|SUPERIORITY|||||||0.4106||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4106
71784983|NCT03462082|143069202|SUPERIORITY|||||||0.85||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.850
71784984|NCT03462082|143069202|SUPERIORITY|||||||0.712||||||"Holm-adjusted P-Value: 1.00~\*Shimmer for Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS"|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.712
71784985|NCT03462082|143069203|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|Asymmetric STN-DBS 1 (right STN-DBS reduced) vs. Bilateral STN-DBS||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.501
71784986|NCT03462082|143069203|SUPERIORITY|||||||0.216||||||Asymmetric STN-DBS 2 (left STN-DBS reduced) vs. Bilateral STN-DBS|Mixed Models Analysis|||Bilateral (baseline) values are the average of the outcome measure data obtained during the 2 bilateral (baseline) conditions: 1) at enrollment before randomization and 2) after randomization. These average values are used to compare the changes associated with the 2 asymmetric conditions.||||0.216
71784987|NCT03462082|143069204|SUPERIORITY||||||>|0.05||||||Non-adjusted P-Values were \>0.05 and Holm-adjusted P-Values were 1.00 for all comparisons, except for the Hopkins Verbal Learning Test-Revised: Delayed Recall. For this test, the non-adjusted P-Value was 0.04 and the Holm-adjusted P-Value was 0.44.|Friedman test|Using ranks for repeated measures (3 conditions)||||||>0.05
71784988|NCT03454997|143069214|SUPERIORITY||Mean Difference (Net)|5.5|||||TWO_SIDED|95.0|3.9|7.1||||||comparison of baseline and 6 months across both groups||7.1|3.9|
71784989|NCT03454997|143069214|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||||||between groups differences of change between baseline and 6 months||1.1|-2.3|
71784990|NCT03454997|143069215|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.4|0.4||||||leading behavioral weight loss group baseline to 6 months comparison||0.4|-1.4|
71784991|NCT03454997|143069215|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-2.0|1.0||||||leading behavioral weight loss group between group comparison of change||1.0|-2.0|
71784992|NCT03454997|143069215|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.4|0.2||||||completing weight ins baseline to 6 month comparison||0.2|-1.4|
71784993|NCT03454997|143069215|SUPERIORITY||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.5|0.5||||||completing weigh ins between groups comparison of change||0.5|-2.5|
71784994|NCT03454997|143069215|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.2|0.3||||||managing a group session baseline to 6 months comparison||0.3|-1.2|
71784995|NCT03454997|143069215|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.0|1.1||||||managing a group session between groups comparison of change||1.1|-2.0|
71784996|NCT03454997|143069216|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-2.0|2.9||||||comparison between baseline and 6 months across groups||2.9|-2.0|
71784997|NCT03454997|143069216|SUPERIORITY||Mean Difference (Net)|-4.1|||||TWO_SIDED|95.0|-9.1|0.8||||||between groups comparison of change post training to 6 months||0.8|-9.1|
71784998|NCT03454997|143069217|SUPERIORITY||Mean Difference (Net)|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||comparison of baseline to 6 months across both groups||0.3|-6.9|
71784999|NCT03454997|143069217|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-11.4|1.8||||||comparison of between group differences baseline to 6 months||1.8|-11.4|
71669440|NCT02452476|142855846|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.634|TWO_SIDED|95.0|-3.9|6.36|||Mixed Models Analysis|||Day 7, post dose||6.36|-3.90|0.634
71785000|NCT03454997|143069218|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||Comparison of Baseline \& 6 Months across both groups||1.1|-0.4|
71785001|NCT03454997|143069218|SUPERIORITY||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.0|0.2||||||Between Groups Differences of Change between Baseline \& 6 Months||0.2|-2.0|
71785002|NCT03454997|143069219|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.3||||||comparison of between group differences baseline to 6 months||3.3|-4.5|
71669441|NCT02452476|142855847|SUPERIORITY|Mortality or BPD incidence at 36-week PMA was compared by treatment, using Cochran-Mantel-Haenszel (CMH), adjusting for stratification gestational age (GA) group. Relative risk (RR) and its 95% confidence interval are also provided.|Relative risk|1.03||||0.811|TWO_SIDED|95.0|0.81|1.32|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of BPD||1.32|0.81|0.811
71669442|NCT02452476|142855847|SUPERIORITY||Relative risk|1.0||||0.972|TWO_SIDED|95.0|0.81|1.25|||Cochran-Mantel-Haenszel|||Week 36 PMA Incidence of Mortality/BPD||1.25|0.81|0.972
71669443|NCT02452476|142855847|SUPERIORITY||Relative risk|0.74||||0.619|TWO_SIDED|95.0|0.23|2.42|||Cochran-Mantel-Haenszel|||Week 36 PMA Mortality||2.42|0.23|0.619
71753200|NCT03270436|143009282|SUPERIORITY|||||||0.0293||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0293
71753201|NCT03270436|143009282|SUPERIORITY|||||||0.4686||||||The p-value above reflects results of between-arms analysis of mean change in systolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4686
71753202|NCT03270436|143009283|SUPERIORITY|||||||0.0068||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.0068
71753203|NCT03270436|143009283|SUPERIORITY|||||||0.9181||||||The p-value above reflects results of between-arms analysis of mean change in diastolic blood pressure from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9181
71753204|NCT03270436|143009284|SUPERIORITY|||||||0.5984||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.5984
71753205|NCT03270436|143009284|SUPERIORITY|||||||0.3376||||||The p-value above reflects results of between-arms analysis of mean change in sugar-sweetened beverages consumed per day from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.3376
71753206|NCT03270436|143009285|SUPERIORITY|||||||0.296||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.2960
71753207|NCT03270436|143009285|SUPERIORITY|||||||0.1519||||||The p-value above reflects results of between-arms analysis of mean change in fruit \& vegetable consumption scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1519
71753208|NCT03270436|143009286|SUPERIORITY|||||||0.2824||||||The p-value above reflects results of between-arms analysis of change from baseline to immediate post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.2824
71753209|NCT03270436|143009286|SUPERIORITY|||||||0.7547||||||The p-value above reflects results of between-arms analysis of change from baseline to 6 months post-intervention. Analyses do not include imputed values.|Mantel Haenszel|The model includes only the study arm and time interaction.||Adjusted repeated measures generalized estimating equations (GEE) model.||||0.7547
71753210|NCT03270436|143009287|SUPERIORITY|||||||0.6928||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.6928
71669444|NCT02452476|142855847|SUPERIORITY||Relative risk|1.46||||0.602|TWO_SIDED|95.0|0.35|6.09|||Cochran-Mantel-Haenszel|||Day 28 PNA Mortality||6.09|0.35|0.602
71669445|NCT02452476|142855847|SUPERIORITY||Relative risk|0.56||||0.606|TWO_SIDED|95.0|0.06|5.29|||Cochran-Mantel-Haenszel|||Day 14 PNA RDS-associated mortality in 14 days of life||5.29|0.06|0.606
71669446|NCT02452476|142855848|SUPERIORITY||Odds Ratio (OR)|0.69||||0.409|TWO_SIDED|95.0|0.3|1.57|||Fisher Exact|||||1.57|0.30|0.409
71669447|NCT02452476|142855849|SUPERIORITY|The percentage of patients requiring at least one rescue surfactant dose were compared by treatment group using the Fisher's exact test at 5% significance interval. Odds ratio (OR) and related exact 95% CI are also provided.|Odds Ratio (OR)|1.21||||0.689|TWO_SIDED|95.0|0.55|2.67|||Fisher Exact|||The percentage of patients requiring at least one rescue surfactant dose.||2.67|0.55|0.689
71669448|NCT02452476|142855850|SUPERIORITY|||||||0.935|||||||Wilcoxon (Mann-Whitney)|||||||0.935
71669449|NCT02654054|142855943|SUPERIORITY||Odds Ratio (OR)|56.79|||<|0.001|TWO_SIDED|95.0|23.002|140.227||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||140.227|23.002|< 0.001
71669450|NCT02654054|142855943|SUPERIORITY||Odds Ratio (OR)|22.98|||<|0.001|TWO_SIDED|95.0|10.466|50.451||The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.|Regression, Logistic|||||50.451|10.466|< 0.001
71785003|NCT03454997|143069219|SUPERIORITY||Mean Difference (Net)|-1.6|||||TWO_SIDED|95.0|-3.1|0.2||||||comparison of baseline to 6 months across groups||0.2|-3.1|
71785004|NCT03454997|143069220|SUPERIORITY||Mean Difference (Net)|-3.8|||||TWO_SIDED|95.0|-6.1|-1.6||||||comparison of baseline and 6 months across groups||-1.6|-6.1|
71785005|NCT03454997|143069220|SUPERIORITY||Mean Difference (Net)|-6.6|||||TWO_SIDED|95.0|-20.2|6.9||||||between groups differences of change between baseline to 6 months||6.9|-20.2|
71785006|NCT00299975|143069231|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
71785007|NCT00299975|143069232|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis.||||||<0.05
71785008|NCT00299975|143069233|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785009|NCT00299975|143069234|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785010|NCT00299975|143069235|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between three treatment groups in each time frame.||||||<0.05
71785011|NCT00299975|143069236|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785012|NCT00299975|143069237|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785013|NCT00299975|143069238|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785014|NCT00299975|143069239|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785015|NCT00299975|143069240|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785016|NCT00299975|143069241|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71785017|NCT00299975|143069243|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71785018|NCT00299975|143069244|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71785019|NCT00299975|143069245|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71785020|NCT00299975|143069246|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.||||||<0.05
71785021|NCT01115101|143069258|NON_INFERIORITY_OR_EQUIVALENCE|VAS score at 24h were defined as primary endpoint because of the expectation of the maximal effect at this time. Testing for differences of continuous variables between the study groups at baseline was accomplished by the 2-sample t test for independent samples or the Mann-Whitney U test, as appropriate.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|<|0.05||95.0|||||Chi-squared|Test selection was based on evaluating the variables for normal distribution employing the Kolmogorov-Smirnov test.||"The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time)."||||<0.05
71785022|NCT02454296|143069280|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71785023|NCT02454296|143069281|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71785024|NCT02454296|143069282|SUPERIORITY_OR_OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71785025|NCT01370356|143069322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.0001|TWO_SIDED|95.0|6.09|12.53||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.||12.53|6.09|<0.0001
71785026|NCT01370356|143069323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.0001|TWO_SIDED|95.0|4.21|7.61||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||7.61|4.21|<0.0001
71785027|NCT01370356|143069324|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.94|5.5||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 - 24, 2) CA for Weeks 21 - 24, 3) CA for Weeks 21 - 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||5.50|2.94|<0.0001
71836362|NCT02596126|143178405|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|5.26|||<|0.05|TWO_SIDED|95.0|3.59|6.94|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||6.94|3.59|< 0.05
71836363|NCT02596126|143178406|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|4.55|||<|0.05|TWO_SIDED|95.0|-4.35|13.46|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||13.46|-4.35|< 0.05
71836364|NCT02596126|143178407|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|7.11|||<|0.05|TWO_SIDED|95.0|5.55|8.67|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.67|5.55|< 0.05
71836365|NCT02596126|143178408|EQUIVALENCE|Mean and standard devation for each score will be reported by treatment group at 6 months and 2 years. Comparison of mean scores between treatment groups at 6 months and 2 years will be made using a two-sample t-test. The difference in mean score and 95% CI will be reported.|Mean Difference (Final Values)|6.6|||<|0.05|TWO_SIDED|95.0|4.93|8.27|||t-test, 2 sided|||Patient satisfaction is measured at visit 1 (6 months) and visit 3 (2 years) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument comprising of four domains: effectiveness (questions 1 to 3), side effects (questions 4 to 8), convenience (questions 9 to 11) and global satisfaction (questions 12 to 14).||8.27|4.93|< 0.05
71836366|NCT02596126|143178409|SUPERIORITY|Time to first event will be investigated using Cox proportional hazards regression. Hazard ratios and 95% confidence intervals will be obtained from the Cox proportional hazards model. P-values will be obtained using the log-rank test.|Hazard Ratio (HR)|1.42|||<|0.05|TWO_SIDED|95.0|0.97|2.07|||Log Rank|||Statistical analysis title - Non-cardiovascular death||2.07|0.97|< 0.05
71836367|NCT00812461|143178419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.68||0.012|TWO_SIDED|95.0|-3.07|-0.38|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||-0.38|-3.07|0.012
71836368|NCT00812461|143178420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.95|STANDARD_ERROR_OF_MEAN|2.89||0.088|TWO_SIDED|95.0|-10.63|0.73|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.73|-10.63|0.088
71836369|NCT00812461|143178421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.63|TWO_SIDED|95.0|0.67|1.27|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.27|0.67|0.630
71836370|NCT00812461|143178422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.02|-0.44|0.029
71836371|NCT00812461|143178423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.111|TWO_SIDED|95.0|-0.38|0.04|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||0.04|-0.38|0.111
71845418|NCT01478594|143205120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.505|||||TWO_SIDED|95.0|0.585|3.873|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.873|0.585|
71896258|NCT02532543|143314622|SUPERIORITY|||||||0.823|||||||ANOVA|||Comparison between each arm/group of change in mid palatal soft tissue height||||0.823
71785028|NCT01370356|143069325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.03|12.51||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||12.51|6.03|<0.0001
71785029|NCT01370356|143069325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.51|5.98||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||5.98|3.51|<0.0001
71785030|NCT01370356|143069325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.66|||<|0.0001|TWO_SIDED|95.0|2.05|3.44||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.||3.44|2.05|<0.0001
71785031|NCT01370356|143069326|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|2.05|3.47||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.||3.47|2.05|<0.0001
71785032|NCT00729651|143069327|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.0|0.08|||Cochran-Mantel-Haenszel|Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.08|0.00|<0.0001
71785033|NCT00729651|143069328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091||95.0|||||ANCOVA|Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.||||||0.0091
71785034|NCT00729651|143069329|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.01|0.04|||Cochran-Mantel-Haenszel|It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.|||0.04|0.01|<0.0001
71785035|NCT01218243|143069368|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.51|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|2.67|6.36|||ANCOVA|||||6.36|2.67|< 0.01
71785036|NCT01218243|143069369|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|6.6|>|0.05|TWO_SIDED|95.0|-9.76|16.44|||Wilcoxon (Mann-Whitney)|||||16.44|-9.76|>0.05
71785037|NCT01218243|143069370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.184|STANDARD_ERROR_OF_MEAN|0.8|>|0.05|TWO_SIDED|95.0|-1.41|1.78|||ANCOVA|||||1.78|-1.41|> 0.05
71785038|NCT01218243|143069371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|0.93|<|0.01|TWO_SIDED|95.0|1.36|5.05|||ANCOVA|||||5.05|1.36|< 0.01
71785039|NCT01218243|143069372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.12|STANDARD_ERROR_OF_MEAN|1.03|<|0.01|TWO_SIDED|95.0|2.07|6.18|||ANCOVA|||||6.18|2.07|<0.01
71785040|NCT01049308|143069373|SUPERIORITY_OR_OTHER||percentage|57.6|||||TWO_SIDED|||||||||Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure||||
71785041|NCT00545662|143069377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.83|1.14||a priori threshold for statistical significance is 0.05|Regression, Logistic|Logistic regression estimated global OR. GEE accounted for correlations of the scales. Models adjusted for site \& injury severity.|The odds in the citicoline group were compared to the odds in the placebo group.|"Null hypothesis: The placebo and citicoline groups do not differ at 90-days on the Core Battery~Power:~1. Two sided type I error of 0.05~2. 85% power~3. Expected OR=1.40 for the global statistic~4. Response rate in the control group~5. Correlations among the nine measures were accounted for. Response rates for the whole sample were a weighted average of the rates provided by TBI severity.~1240 participants were required to detect an OR \>= 1.4 for the global statistic."||1.14|0.83|0.76
71785042|NCT03926169|143069378|SUPERIORITY||Adjusted Response Rate Difference (%)|6.0||||0.422|TWO_SIDED|97.5|-10.8|22.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||22.8|-10.8|0.422
71836372|NCT00812461|143178424|SUPERIORITY_OR_OTHER||Ratio to placebo|0.96||||0.529|TWO_SIDED|95.0|0.86|1.08|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 224 participants in the placebo group and 207 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.08|0.86|0.529
71845419|NCT01478594|143205121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.921|||||TWO_SIDED|95.0|0.356|2.385|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.385|0.356|
71785043|NCT03926169|143069378|SUPERIORITY||Adjusted Response Rate Difference (%)|1.3||||0.858|TWO_SIDED|97.5|-15.4|18.1||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||18.1|-15.4|0.858
71785044|NCT03926169|143069379|SUPERIORITY||Adjusted Response Rate Difference (%)|-3.0||||0.725|TWO_SIDED|97.5|-21.8|15.9||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||15.9|-21.8|0.725
71891866|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.09|||||TWO_SIDED|95.0|0.01|0.16||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.16|0.01|
71753211|NCT03270436|143009287|SUPERIORITY|||||||0.4947||||||The p-value above reflects results of between-arms analysis of mean change in eating self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4947
71753212|NCT03270436|143009288|SUPERIORITY|||||||0.1539||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to immediate post-intervention. Analyses do not include imputed values|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1539
71753213|NCT03270436|143009288|SUPERIORITY|||||||0.1878||||||The p-value above reflects results of between-arms analysis of mean change in physical activity self-efficacy scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.1878
71753214|NCT03270436|143009289|SUPERIORITY|||||||0.4322||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to immediate post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.4322
71753215|NCT03270436|143009289|SUPERIORITY|||||||0.9529||||||The p-value above reflects results of between-arms analysis of mean change in family support scale scores from baseline to 6 months post-intervention. Analyses do not include imputed values.|linear mixed effects regression|Model includes group, time, g x t interaction, state, age, gender, marital status, employment, education, and accounts for clustering within churches.||Repeated measures regression model used all available participant data (no listwise deletion).||||0.9529
71753216|NCT02177695|143009294|SUPERIORITY||Odds Ratio (OR)|2.63||||0.1|TWO_SIDED|95.0|0.82|8.36|||Regression, Logistic|||To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.||8.36|0.82|0.1
71753217|NCT02177695|143009294|SUPERIORITY||Odds Ratio (OR)|1.12||||0.82|TWO_SIDED|95.0|0.42|2.95|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.||2.95|0.42|0.82
71753218|NCT02177695|143009295|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.11|4.89|||Regression, Logistic|||To determine the relationship of GC COXEN scores to \<= pT1, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the GC treatment group.||4.89|1.11|0.02
71753219|NCT02177695|143009295|SUPERIORITY||Odds Ratio (OR)|0.9||||0.76|TWO_SIDED|95.0|0.46|1.75|||Regression, Logistic|||To determine the relationship of ddMVAC COXEN scores to \<=pT1, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT1 or better within the ddMVAC treatment group.||1.75|0.46|0.76
71753220|NCT00904943|143009324|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|104.27|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Mean falls within 80-125.|||||
71753221|NCT00904943|143009325|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|102.35|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
71753222|NCT00904943|143009326|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|103.66|||||TWO_SIDED||||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.|||||
71753223|NCT05546476|143009328|SUPERIORITY||Difference in Posterior Median|1.33|||||TWO_SIDED|90.0|0.49|2.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||2.34|0.49|
71753224|NCT05546476|143009328|SUPERIORITY||Difference in Posterior Median|2.08|||||TWO_SIDED|90.0|1.08|3.15||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||3.15|1.08|
71753225|NCT05546476|143009328|SUPERIORITY||Difference in Posterior Median|3.0|||||TWO_SIDED|90.0|1.68|4.34||||||Bayesian Emax model was used for statistical calculation. The posterior medians and 90% credible intervals (5th and 95th percentiles of the relevant posterior distribution) were reported for differences relative to placebo). No adjustments were made for multiplicity.||4.34|1.68|
71753226|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|53.36|||=|0.826|TWO_SIDED|90.0|-40.89|147.6|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||147.60|-40.89|=0.8260
71753227|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|-37.9|||=|0.254|TWO_SIDED|90.0|-132.94|57.14|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||57.14|-132.94|=0.2540
71753228|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|-1.95|||=|0.487|TWO_SIDED|90.0|-101.63|97.73|||MMRM analysis; 1-sided|||Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||97.73|-101.63|=0.4870
71753229|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|37.76|||=|0.0497|TWO_SIDED|90.0|0.07|75.46|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||75.46|0.07|=0.0497
71753230|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|-4.36|||=|0.5745|TWO_SIDED|90.0|-42.94|34.22|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||34.22|-42.94|=0.5745
71753231|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|49.85|||=|0.0189|TWO_SIDED|90.0|10.62|89.08|||MMRM analysis; 1-sided|||Non-Sedentary Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||89.08|10.62|=0.0189
71785045|NCT03926169|143069379|SUPERIORITY||Adjusted Response Rate Difference (%)|8.8||||0.301|TWO_SIDED|97.5|-10.3|27.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||27.8|-10.3|0.301
71785046|NCT03926169|143069380|SUPERIORITY||Adjusted Response Rate Difference (%)|3.7||||0.65|TWO_SIDED|97.5|-14.5|21.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||21.8|-14.5|0.650
71669451|NCT02654054|142855944|SUPERIORITY||LS Mean of Difference|-222.3|STANDARD_ERROR_OF_MEAN|20.77|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71753232|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|8.51|||=|0.1302|TWO_SIDED|90.0|-4.0|21.03|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.03|-4.00|=0.1302
71753233|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|4.49|||=|0.278|TWO_SIDED|90.0|-8.18|17.16|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||17.16|-8.18|=0.2780
71753234|NCT05546476|143009329|SUPERIORITY||Difference in LS Mean|8.11|||=|0.1529|TWO_SIDED|90.0|-5.01|21.23|||MMRM analysis; 1-sided|||Moderate to Vigorous Physical Activity Time: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||21.23|-5.01|=0.1529
71785047|NCT03926169|143069380|SUPERIORITY||Adjusted Response Rate Difference (%)|12.3||||0.147|TWO_SIDED|97.5|-6.7|31.3||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||31.3|-6.7|0.147
71785048|NCT03926169|143069381|SUPERIORITY||Adjusted Response Rate Difference (%)|-6.5||||0.342|TWO_SIDED|97.5|-21.8|8.8||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||8.8|-21.8|0.342
71845420|NCT01478594|143205121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|0.462|3.22|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.220|0.462|
71669452|NCT02654054|142855944|SUPERIORITY||LS Mean of Difference|-177.5|STANDARD_ERROR_OF_MEAN|18.24|<|0.001|TWO_SIDED|||||The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|ANCOVA|||||||< 0.001
71785049|NCT03926169|143069381|SUPERIORITY||Adjusted Response Rate Difference (%)|-10.6||||0.108|TWO_SIDED|97.5|-25.3|4.2||Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.|Cochran-Mantel-Haenszel|||||4.2|-25.3|0.108
71785050|NCT03926169|143069382|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.97||0.179|TWO_SIDED|97.5|-3.5|0.9||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.9|-3.5|0.179
71785051|NCT03926169|143069382|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.98||0.105|TWO_SIDED|97.5|-3.8|0.6||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.6|-3.8|0.105
71785052|NCT03926169|143069383|SUPERIORITY||LS Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.3385||0.727|TWO_SIDED|97.5|-0.646|0.883||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.883|-0.646|0.727
71785053|NCT03926169|143069383|SUPERIORITY||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.3273||0.963|TWO_SIDED|97.5|-0.755|0.724||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.724|-0.755|0.963
71785054|NCT03926169|143069384|SUPERIORITY||LS Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.2941||0.886|TWO_SIDED|97.5|-0.622|0.706||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.706|-0.622|0.886
71785055|NCT03926169|143069384|SUPERIORITY||LS Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.2851||0.409|TWO_SIDED|97.5|-0.408|0.879||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.879|-0.408|0.409
71785056|NCT03926169|143069385|SUPERIORITY||LS Mean Difference|-0.252|STANDARD_ERROR_OF_MEAN|0.3212||0.434|TWO_SIDED|97.5|-0.977|0.473||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.473|-0.977|0.434
71785057|NCT03926169|143069385|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.3123||0.813|TWO_SIDED|97.5|-0.779|0.631||Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.|mixed-effect model repeat measures|||||0.631|-0.779|0.813
71785058|NCT02615145|143069394|SUPERIORITY|||||||0.111||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||||0.1110
71785059|NCT02615145|143069394|SUPERIORITY||difference in LS means|1.64||||0.2704|TWO_SIDED|95.0|-1.28|4.56||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||4.56|-1.28|0.2704
71785060|NCT02615145|143069394|SUPERIORITY||difference in LS means|-0.09||||0.9516|TWO_SIDED|95.0|-3.17|2.98||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||2.98|-3.17|0.9516
71836373|NCT00812461|143178425|SUPERIORITY_OR_OTHER||Ratio to placebo|0.92||||0.049|TWO_SIDED|95.0|0.84|1.0|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 222 participants in the placebo group and 205 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.00|0.84|0.049
71836374|NCT04402489|143178445|SUPERIORITY||Least Square Mean Difference vs Placebo|9.8|STANDARD_ERROR_OF_MEAN|14.35||0.496|TWO_SIDED|95.0|-18.52|38.12|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - lower dose||38.12|-18.52|0.496
71836375|NCT04402489|143178445|SUPERIORITY||Least Square Mean Difference vs Placebo|22.7|STANDARD_ERROR_OF_MEAN|14.38||0.116|TWO_SIDED|95.0|-5.68|51.09|||Mixed-effect model for repeated measures|||Change from BL at Week 26 (DBT EOT) - higher dose||51.09|-5.68|0.116
71836376|NCT04402489|143178446|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.84|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.23|-0.44|||Mixed-effect model for repeated measures|||||-0.44|-1.23|< 0.001
71836377|NCT04402489|143178446|SUPERIORITY||Least Square Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.83|-1.03|||Mixed-effect model for repeated measures|||||-1.03|-1.83|< 0.001
71836378|NCT04402489|143178447|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.76||||0.199|TWO_SIDED|95.0|0.49|1.16|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||1.16|0.49|0.199
71669453|NCT02654054|142855945|SUPERIORITY||Between-Group Difference (%)|79.6|||<|0.001|TWO_SIDED|95.0|71.13|88.16||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||88.16|71.13|< 0.001
71669454|NCT02654054|142855945|SUPERIORITY||Between-Group Difference (%)|52.4|||<|0.001|TWO_SIDED|95.0|44.11|60.76||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|Chi-square or Fisher's exact test|||||60.76|44.11|< 0.001
71753235|NCT05546476|143009330|SUPERIORITY||Difference in LS Mean|-130.27|||=|0.5762|TWO_SIDED|90.0|-1257.31|996.77|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||996.77|-1257.31|=0.5762
71753236|NCT05546476|143009330|SUPERIORITY||Difference in LS Mean|724.14|||=|0.1486|TWO_SIDED|90.0|-425.81|1874.09|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1874.09|-425.81|=0.1486
71753237|NCT05546476|143009330|SUPERIORITY||Difference in LS Mean|185.62|||=|0.3972|TWO_SIDED|90.0|-997.94|1369.18|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1369.18|-997.94|=0.3972
71753238|NCT05546476|143009331|SUPERIORITY||Difference in LS Mean|1587.26|||=|0.0985|TWO_SIDED|90.0|-443.79|3618.31|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3618.31|-443.79|=0.0985
71753239|NCT05546476|143009331|SUPERIORITY||Difference in LS Mean|-98.54|||=|0.5315|TWO_SIDED|90.0|-2169.67|1972.58|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1972.58|-2169.67|=0.5315
71753240|NCT05546476|143009331|SUPERIORITY||Difference in LS Mean|2203.18|||=|0.0437|TWO_SIDED|90.0|84.51|4321.85|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||4321.85|84.51|=0.0437
71785061|NCT02615145|143069394|SUPERIORITY||difference in LS means|-1.73||||0.0489|TWO_SIDED|95.0|-3.46|-0.01||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12||-0.01|-3.46|0.0489
71785062|NCT02615145|143069394|SUPERIORITY|||||||0.9785||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||||0.9785
71785063|NCT02615145|143069394|SUPERIORITY||difference in LS means|-0.13||||0.9379|TWO_SIDED|95.0|-3.37|3.11||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.11|-3.37|0.9379
71785064|NCT02615145|143069394|SUPERIORITY||difference in LS means|0.07||||0.9678|TWO_SIDED|95.0|-3.33|3.47||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||3.47|-3.33|0.9678
71785065|NCT02615145|143069394|SUPERIORITY||difference in LS means|0.2||||0.8373|TWO_SIDED|95.0|-1.7|2.1||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48||2.10|-1.70|0.8373
71785066|NCT02615145|143069394|SUPERIORITY||Mean Difference (Final Values)|6.37|||<|0.0001|TWO_SIDED|95.0|5.417|7.32|||paired t-test|paired t-test of whether difference in means is 0||Week 12 vs Baseline across all participants||7.320|5.417|< 0.0001
71785067|NCT02615145|143069394|SUPERIORITY||Mean Difference (Final Values)|10.15|||<|0.0001|TWO_SIDED|95.0|8.936|11.362|||paired t-test|paired t-test of whether difference in means is 0||Week 48 vs Baseline across all participants||11.362|8.936|< 0.0001
71785068|NCT02615145|143069399|SUPERIORITY|||||||0.5751||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EOT||||0.5751
71785069|NCT02615145|143069399|SUPERIORITY||difference in LS means|2.29||||0.5176|TWO_SIDED|95.0|-4.66|9.23||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||9.23|-4.66|0.5176
71785070|NCT02615145|143069399|SUPERIORITY||difference in LS means|0.324||||0.9308|TWO_SIDED|95.0|-7.0|7.64||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||7.64|-7.00|0.9308
71785071|NCT02615145|143069399|SUPERIORITY||difference in LS means|-1.96||||0.3462|TWO_SIDED|95.0|-6.06|2.13||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT||2.13|-6.06|0.3462
71785072|NCT02615145|143069399|SUPERIORITY|||||||0.7016||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 Weeks after EoT||||0.7016
71785073|NCT02615145|143069399|SUPERIORITY||difference in LS means|-2.61||||0.4002|TWO_SIDED|95.0|-8.71|3.49||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.49|-8.71|0.4002
71836379|NCT04402489|143178447|SUPERIORITY|Negative binomial regression model with log link was used.|Incident rate ratio|0.55||||0.006|TWO_SIDED|95.0|0.36|0.84|||Refer to comments below:|Negative binomial regression model with log link was used for other method.||||0.84|0.36|0.006
71669455|NCT02654054|142855946|SUPERIORITY||LS Mean of Difference|-234.0|STANDARD_ERROR_OF_MEAN|19.27|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71669456|NCT02654054|142855946|SUPERIORITY||LS Mean of Difference|-192.5|STANDARD_ERROR_OF_MEAN|16.7|<|0.001|TWO_SIDED|||||The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71669457|NCT02654054|142855947|SUPERIORITY||LS Mean of Difference|-240.8|STANDARD_ERROR_OF_MEAN|21.69|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71669458|NCT02654054|142855947|SUPERIORITY||LS Mean of Difference|-198.2|STANDARD_ERROR_OF_MEAN|18.76|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71785074|NCT02615145|143069399|SUPERIORITY||difference in LS means|-2.33||||0.475|TWO_SIDED|95.0|-8.74|4.08||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||4.08|-8.74|0.4750
71785075|NCT02615145|143069399|SUPERIORITY||difference in LS means|0.282||||0.874|TWO_SIDED|95.0|-3.21|3.77||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT||3.77|-3.21|0.8740
71785076|NCT02615145|143069399|SUPERIORITY|||||||0.7211||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||||0.7211
71785077|NCT02615145|143069399|SUPERIORITY||difference in LS means|-3.67||||0.4256|TWO_SIDED|95.0|-12.7|5.39||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.39|-12.7|0.4256
71785078|NCT02615145|143069399|SUPERIORITY||difference in LS means|-3.01||||0.5347|TWO_SIDED|95.0|-12.6|6.54||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||6.54|-12.6|0.5347
71785079|NCT02615145|143069399|SUPERIORITY||difference in LS means|0.654||||0.792|TWO_SIDED|95.0|-4.23|5.54||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F \[0-100\] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT||5.54|-4.23|0.7920
71785080|NCT02615145|143069399|SUPERIORITY||Mean Difference (Final Values)|5.64|||<|0.0001|TWO_SIDED|95.0|3.355|7.935|||paired t-test|paired t-test of mean difference from 0||Baseline to EOT across all participants||7.935|3.355|< 0.0001
71785081|NCT02615145|143069399|SUPERIORITY||Mean Difference (Final Values)|10.21|||<|0.0001|TWO_SIDED|95.0|8.113|12.299|||paired t-test|paired t-test of mean difference versus 0||Baseline vs 12 weeks after EOT across all participants||12.299|8.113|< 0.0001
71785082|NCT02615145|143069399|SUPERIORITY||Mean Difference (Final Values)|10.13|||<|0.0001|TWO_SIDED|95.0|7.259|12.992|||paired t-test|paired t-test of mean difference versus 0||baseline vs 48 weeks after EOT across all participants||12.992|7.259|< 0.0001
71836380|NCT04402489|143178448|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.55|TWO_SIDED|95.0|-0.62|0.33|||mixed-effect model for repeated measures|||||0.33|-0.62|0.55
71836381|NCT04402489|143178448|SUPERIORITY||Least Square Mean Difference vs Placebo|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.343|TWO_SIDED|95.0|-0.72|0.25|||mixed-effect model for repeated measures|||||0.25|-0.72|0.343
71785083|NCT02615145|143069400|SUPERIORITY|||||||0.3869||||||Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||||0.3869
71785084|NCT02615145|143069400|SUPERIORITY||difference in LS means|-1.89||||0.3125|TWO_SIDED|95.0|-5.57|1.79||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.79|-5.57|0.3125
71785085|NCT02615145|143069400|SUPERIORITY||difference in LS means|-2.65||||0.1741|TWO_SIDED|95.0|-6.48|1.18||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.18|-6.48|0.1741
71785086|NCT02615145|143069400|SUPERIORITY||difference in LS means|-0.76||||0.4941|TWO_SIDED|95.0|-2.94|1.42||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||||1.42|-2.94|0.4941
71785087|NCT02615145|143069400|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8842|TWO_SIDED|95.0|-1.271|1.096|||paired t-test|paired t-test of mean difference vs 0||Change from Baseline to Final visit across all participants||1.096|-1.271|0.8842
71785088|NCT03727347|143069404|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the improvement (decrease) in rTNSS mean score, from baseline to 12 weeks, would exceed 1 point||||||<0.0001
71785089|NCT03200860|143069410|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.18
71785090|NCT03200860|143069411|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
71785091|NCT03200860|143069412|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71785092|NCT03200860|143069413|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71785093|NCT03200860|143069414|SUPERIORITY|||||||0.31|||||||Regression, Logistic|||||||0.31
71785094|NCT03200860|143069415|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
71836382|NCT04402489|143178449|SUPERIORITY||Odds Ratio (OR)|0.805||||0.642|TWO_SIDED|95.0|0.323|2.007|||Regression, Logistic|||||2.007|0.323|0.642
71785095|NCT02634320|143069434|OTHER|Statistical test is to confirm the change from baseline is statistically different from 0.||||||0.078||||||Change from baseline at last on-treatment visit|t-test, 2 sided|||||||0.078
71836383|NCT04402489|143178449|SUPERIORITY||Odds Ratio (OR)|1.412||||0.431|TWO_SIDED|95.0|0.598|3.336|||Regression, Logistic|||||3.336|0.598|0.431
71669459|NCT02654054|142855948|SUPERIORITY||Between-Group Difference (%)|49.7|||<|0.001|TWO_SIDED|95.0|30.27|69.18||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||69.18|30.27|< 0.001
71753241|NCT05546476|143009332|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5052|TWO_SIDED|90.0|-0.046|0.045|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.046|=0.5052
71753242|NCT05546476|143009332|SUPERIORITY||Difference in LS Mean|-0.004|||=|0.5599|TWO_SIDED|90.0|-0.05|0.042|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.042|-0.050|=0.5599
71753243|NCT05546476|143009332|SUPERIORITY||Difference in LS Mean|0.017|||=|0.277|TWO_SIDED|90.0|-0.03|0.064|||MMRM analysis; 1-sided|||Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.064|-0.030|=0.2770
71753244|NCT05546476|143009332|SUPERIORITY||Difference in LS Mean|0.0|||=|0.5047|TWO_SIDED|90.0|-0.071|0.07|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.070|-0.071|=0.5047
71753245|NCT05546476|143009332|SUPERIORITY||Difference in LS Mean|-0.026|||=|0.7316|TWO_SIDED|90.0|-0.097|0.045|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.045|-0.097|=0.7316
71753246|NCT05546476|143009332|SUPERIORITY||Difference in LS Mean|0.01|||=|0.4145|TWO_SIDED|90.0|-0.063|0.082|||MMRM analysis; 1-sided|||95th Percentile of Gait Speed: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.082|-0.063|=0.4145
71753247|NCT05546476|143009333|SUPERIORITY||Difference in LS Mean|4.24|||=|0.0114|TWO_SIDED|90.0|1.19|7.28|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.28|1.19|=0.0114
71753248|NCT05546476|143009333|SUPERIORITY||Difference in LS Mean|0.64|||=|0.36|TWO_SIDED|90.0|-2.3|3.57|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.57|-2.30|=0.3600
71753249|NCT05546476|143009333|SUPERIORITY||Difference in LS Mean|4.11|||=|0.0138|TWO_SIDED|90.0|1.06|7.17|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||7.17|1.06|=0.0138
71753250|NCT05546476|143009334|SUPERIORITY||Difference in LS Mean|2.35|||=|0.009|TWO_SIDED|90.0|0.72|3.97|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.97|0.72|=0.0090
71753251|NCT05546476|143009334|SUPERIORITY||Difference in LS Mean|0.0|||=|0.4987|TWO_SIDED|90.0|-1.55|1.56|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.56|-1.55|=0.4987
71785096|NCT02970422|143069442|OTHER|||||||0.91|||||||Chi-squared|Chi-squared value= .57||Relief of breathlessness||||.91
71785097|NCT02970422|143069442|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.56||Improve your ability to perform activities in and out of your home||||.31
71785098|NCT02970422|143069442|OTHER|||||||0.96|||||||Chi-squared|Chi-squared value=.32||Prevent lung flare-ups||||.96
71785099|NCT02970422|143069442|OTHER|||||||0.04|||||||Chi-squared|Chi-squared value= 8.09||Discuss COPD and its progression||||.04
71785100|NCT02970422|143069442|OTHER|||||||0.7|||||||Chi-squared|Chi-squared value: 1.41||Improve your physical well-being||||.70
71785101|NCT02970422|143069442|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 10.81||Relief of breathlessness||||.01
71785102|NCT02970422|143069442|OTHER|||||||0.49|||||||Chi-squared|Chi-squared value= 2.41||Improve your ability to perform activities in and out of your home||||.49
71785103|NCT02970422|143069442|OTHER|||||||0.93|||||||Chi-squared|Chi-squared value= .44||Prevent lung flare-ups||||.93
71785104|NCT02970422|143069442|OTHER|||||||0.6|||||||Chi-squared|Chi-squared value= 1.87||Discuss COPD and its progression||||.60
71891867|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.14|||||TWO_SIDED|95.0|0.06|0.21||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.21|0.06|
71891868|NCT03193866|143305374|SUPERIORITY||Difference in proportion|0.23|||||TWO_SIDED|95.0|0.13|0.33||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.33|0.13|
71891869|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-71.6|||||TWO_SIDED|95.0|-76.6|-66.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-66.6|-76.6|
71785105|NCT02970422|143069442|OTHER|||||||0.31|||||||Chi-squared|Chi-squared value= 3.61||Improve your physical well-being||||.31
71785106|NCT02970422|143069443|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value: 1.31||To relieve breathlessness in adults living with COPD||||.73
71785107|NCT02970422|143069443|OTHER|||||||0.23|||||||Chi-squared|Chi-squared value= 4.28||To prevent the development of COPD||||.23
71785108|NCT02970422|143069443|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.51||To prevent lung flare-ups in adults living with COPD||||.14
71785109|NCT02970422|143069443|OTHER|||||||0.52|||||||Chi-squared|Chi-squared value= 2.28||To increase the ability of adults living with COPD to exercise||||.52
71785110|NCT02970422|143069443|OTHER|||||||0.11|||||||Chi-squared|Chi-squared value= 5.88||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.11
71785111|NCT02970422|143069443|OTHER|||||||0.14|||||||Chi-squared|Chi-squared value= 5.57||To relieve breathlessness in adults living with COPD||||.14
71891870|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-66.3|||||TWO_SIDED|95.0|-76.3|-56.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-56.4|-76.3|
71785112|NCT02970422|143069443|OTHER|||||||0.73|||||||Chi-squared|Chi-squared value= 1.29||To prevent the development of COPD||||.73
71896259|NCT02532543|143314622|SUPERIORITY|||||||0.243|||||||ANOVA|||Comparison between each arm/group of change in mesial soft tissue height||||0.243
71896260|NCT02532543|143314622|SUPERIORITY|||||||0.756|||||||ANOVA|||Comparison between each arm/group of change in distal soft tissue height||||0.756
71785113|NCT02970422|143069443|OTHER|||||||0.2|||||||Chi-squared|Chi-squared value= 4.64||To prevent lung flare-ups in adults living with COPD||||.20
71785114|NCT02970422|143069443|OTHER|||||||0.17|||||||Chi-squared|Chi-squared value= 5.02||To increase the ability of adults living with COPD to exercise||||.17
71785115|NCT02970422|143069443|OTHER|||||||0.02|||||||Chi-squared|Chi-square value= 9.97||To improve the maximal amount of exercise of adults living with COPD in and out of the home||||.02
71785116|NCT02970422|143069444|OTHER|||||||0.05|||||||Chi-squared|Chi squared value= 17.20||Activity 1: Walking from one place to another outside of your home on a flat surface||||.05
71785117|NCT02970422|143069444|OTHER|||||||0.87|||||||Chi-squared|Chi-squared value= 4.56||Activity 2: Moving from one place to another using motorized transportation||||.87
71785118|NCT02970422|143069444|OTHER|||||||0.65|||||||Chi-squared|Chi-squared value= 6.85||Activity 3: Climbing two or more flights of stairs||||.65
71785119|NCT02970422|143069444|OTHER|||||||0.35|||||||Chi-squared|Chi-squared value= 10.00||Activity 4: Walking up a hill||||.35
71785120|NCT02970422|143069444|OTHER|||||||0.03|||||||Chi-squared|Chi-squared value= 18.75||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.03
71785121|NCT02970422|143069444|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 35.52||Activity 1: Walking from one place to another outside of your home on a flat surface||||.00
71785122|NCT02970422|143069444|OTHER|||||||0.33|||||||Chi-squared|Chi-squared value= 10.23||Activity 2: Moving from one place to another using motorized transportation||||.33
71785123|NCT02970422|143069444|OTHER|||||||0|||||||Chi-squared|Chi-squared value= 23.94||Activity 3: Climbing two or more flights of stairs||||.00
71785124|NCT02970422|143069444|OTHER|||||||0.01|||||||Chi-squared|Chi-squared value= 22.80||Activity 4: Walking up a hill||||.01
71785125|NCT02970422|143069444|OTHER|||||||0.02|||||||Chi-squared|Chi-squared value= 20.43||Activity 5: Participating in regular exercise requiring physical effort, to maintain or improve health or fitness||||.02
71785126|NCT02970422|143069445|OTHER|||||||0|||||||Kruskal-Wallis|Non-parametric led to equal variance (levene's test) which couldn't be assumed, independent samples were taken (Kruskal-Wallis)|||F(3,144)=137.82|||.00
71785127|NCT02970422|143069446|OTHER|||||||0|||||||ANOVA|Factorial ANOVA used because variance could be assumed|||F(3,144)=55.89 Partial ETA squared (effect size)=0.54|||.000
71785128|NCT02970422|143069447|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,142)=7.61|||.00
71785129|NCT02970422|143069448|OTHER|||||||0.31|||||||ANOVA|One-way ANOVA|||F(3,142)=1.21|||.31
71785130|NCT02970422|143069449|OTHER|||||||0.04|||||||Kruskal-Wallis|Non-parametric independent sample Kruskal-Wallis test (failed variance assumed|||F(3,139)=8.09|||.04
71785131|NCT02970422|143069450|OTHER|||||||0|||||||ANOVA|One-way ANOVA|||F(3,143)=8.01|||.00
71785132|NCT02846779|143069462|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.75|1.03||||||||1.03|0.75|
71785133|NCT02846779|143069462|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.77|1.06||||||||1.06|0.77|
71785134|NCT02846779|143069463|SUPERIORITY||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.34|0.05||||||||0.05|-0.34|
71753252|NCT05546476|143009334|SUPERIORITY||Difference in LS Mean|2.3|||=|0.01|TWO_SIDED|90.0|0.68|3.92|||MMRM analysis; 1-sided|||MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||3.92|0.68|=0.0100
71753253|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.43|||=|0.1912|TWO_SIDED|90.0|-0.38|1.24|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.24|-0.38|=0.1912
71753254|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.46|||=|0.1866|TWO_SIDED|90.0|-0.39|1.3|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.30|-0.39|=0.1866
71753255|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.92|||=|0.0349|TWO_SIDED|90.0|0.09|1.75|||MMRM analysis; 1-sided|||Appetite: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.75|0.09|=0.0349
71753256|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.47|||=|0.8754|TWO_SIDED|90.0|-0.2|1.14|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.14|-0.20|=0.8754
71753257|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.38|||=|0.8205|TWO_SIDED|90.0|-0.31|1.08|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.08|-0.31|=0.8205
71753258|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|-0.17|||=|0.3375|TWO_SIDED|90.0|-0.86|0.51|||MMRM analysis; 1-sided|||Nausea: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||0.51|-0.86|=0.3375
71753259|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.66|||=|0.9138|TWO_SIDED|90.0|-0.14|1.45|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.45|-0.14|=0.9138
71753260|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.64|||=|0.9011|TWO_SIDED|90.0|-0.18|1.46|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.46|-0.18|=0.9011
71753261|NCT05546476|143009335|SUPERIORITY||Difference in LS Mean|0.21|||=|0.6618|TWO_SIDED|90.0|-0.61|1.02|||MMRM analysis; 1-sided|||Physical Fatigue: MMRM model included participant as a random term, and baseline, time (as a factor), baseline-by-time interaction, treatment and treatment-by-time interaction, type of therapy \[platinum or not at randomization +/- 28 days\], and type of cancer as fixed terms, with an unstructured covariance matrix and Kenwood-Roger degrees of freedom.||1.02|-0.61|=0.6618
71753262|NCT03583099|143009343|SUPERIORITY||Difference in proportion|4.0||||0.47|TWO_SIDED|95.0|-6.9|15.0|||generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-6.9|0.47
71753263|NCT03583099|143009344|SUPERIORITY||Difference in proportion|10.4||||0.05|TWO_SIDED|95.0|0.1|20.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||20.7|0.1|0.05
71753264|NCT03583099|143009345|SUPERIORITY||Difference in proportion|1.3||||0.75|TWO_SIDED|95.0|-6.7|9.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.2|-6.7|0.75
71753265|NCT03583099|143009346|SUPERIORITY||Difference in proportion|-2.7||||0.54|TWO_SIDED|95.0|-11.5|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||6.1|-11.5|0.54
71785135|NCT02846779|143069463|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.43|-0.06||||||||-0.06|-0.43|
71785136|NCT02846779|143069464|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.95|1.11||||||||1.11|0.95|
71785137|NCT02846779|143069464|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.92|1.06||||||||1.06|0.92|
71785138|NCT02846779|143069465|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.02||||||||1.02|0.97|
71785139|NCT02846779|143069465|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.96|1.0||||||||1.00|0.96|
71785140|NCT02846779|143069466|SUPERIORITY||Risk Ratio (RR)|1.38|||||TWO_SIDED|95.0|1.24|1.53||||||||1.53|1.24|
71785141|NCT02846779|143069466|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.85|1.07||||||||1.07|0.85|
71785142|NCT02846779|143069467|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|1.06|1.41||||||||1.41|1.06|
71785143|NCT02846779|143069467|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.99|1.32||||||||1.32|0.99|
71785144|NCT01325584|143069476|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||.07
71785145|NCT01325584|143069478|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||.53
71785146|NCT01325584|143069479|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||.48
71785147|NCT00887978|143069480|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.089|TWO_SIDED|95.0|-2.0|22.0|||non-parametric ANCOVA|||Using an allocation ratio of 1:1 between UT-15C SR and placebo, a fixed sample size of approximately 266 subjects would provide at least 90% power at a significance level of 0.05 (two-sided hypothesis) to detect a 30 meter between-treatment difference in the change from Baseline in distance traversed during the 6-Minute Walk, assuming a standard deviation of 75 meters. A total sample size of approximately 300 subjects was determined to account for discontinuations during the enrollment period.||22.0|-2.0|0.089
71785148|NCT00887978|143069481|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71785149|NCT00887978|143069482|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) Estimate|0.0||||0.22|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum test|||||0.0|-1.0|0.22
71669460|NCT02654054|142855948|SUPERIORITY||Between-Group Difference (%)|45.4|||<|0.001|TWO_SIDED|95.0|26.9|63.92||The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count \< 5).|chi-square or Fisher's exact test|||||63.92|26.90|< 0.001
71785150|NCT00887978|143069483|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.43|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for the 26 UT-15C subjects and 17 placebo subjects without values reported at Week 16.|Wilcoxon rank sum test|||||0.0|0.0|0.43
71785151|NCT00887978|143069485|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L) estimate|0.0||||0.3|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon rank sum test|||||1.0|0.0|0.30
71785152|NCT00887978|143069488|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|14.0||||0.058|TWO_SIDED|95.0|0.0|28.0|||ANCOVA|||||28.0|0.0|0.058
71785153|NCT00887978|143069489|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|15.0||||0.054|TWO_SIDED|95.0|-1.0|29.0|||ANCOVA|||||29.0|-1.0|0.054
71785154|NCT00887978|143069491|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|4.0||||0.674|TWO_SIDED|95.0|-16.0|24.0|||ANCOVA|||||24.0|-16.0|0.674
71785155|NCT00887978|143069492|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|28.0||||0.059|TWO_SIDED|95.0|1.0|59.0|||ANCOVA|||||59.0|1.0|0.059
71785156|NCT00887978|143069493|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|10.0||||0.22|TWO_SIDED|95.0|-10.0|31.0|||ANCOVA|||||31.0|-10.0|0.22
71785157|NCT00887978|143069494|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|3.0||||0.99|TWO_SIDED|95.0|-23.0|28.0|||ANCOVA|||||28.0|-23.0|0.99
71785158|NCT00887978|143069495|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||0.84||95.0|-25.0|22.0|||ANCOVA|||||22.0|-25.0|0.84
71785159|NCT00040937|143069497|SUPERIORITY_OR_OTHER||4-yr survival (%)|64.0|||||TWO_SIDED|95.0|55.0|74.0|||Kaplan and Meier|||The study was designed to have 82% power for detecting a 50% improvement in survival from a median of 4 years, as observed in SWOG S9321.||74|55|
71785160|NCT02016560|143069509|OTHER||Cox Proportional Hazard|1.581||||0.067|TWO_SIDED|95.0|0.968|2.581||A p-value of \<0.05 was the a priori threshold for statistical significance.|Cox proportional hazards|The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.||The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).||2.581|0.968|0.067
71785161|NCT02016560|143069510|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and Older Cognitively Healthy within amyloid positive group.||||<0.0001
71785162|NCT02016560|143069510|OTHER|||||||0.0622||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between MCI and Older Cognitively Healthy within the amyloid positive group.||||0.0622
71785163|NCT02016560|143069510|OTHER||||||<|0.0001||||||No adjustment for multiple comparisons. No a priori threshold was set.|ANCOVA|Adjusted for age||ANCOVA model comparing the mean SUVr between AD and MCI within the amyloid positive group.||||<0.0001
71785164|NCT02016560|143069511|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero|||||<|0.0001|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid positive subjects only.||||<0.0001
71785165|NCT02016560|143069511|EQUIVALENCE|Test of whether the least squares mean change is significantly different than zero||||||0.7851|||||||Mixed Models Analysis|||SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid negative subjects only.||||0.7851
71785166|NCT02016560|143069512|OTHER||||||||||||||||||The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% confidence intervals ≥50%, for both sensitivity and specificity.|||
71785167|NCT02016560|143069513|OTHER||Pearson's correlation coefficient|-0.0925||||0.4361|TWO_SIDED||||||Pearson|||Pearson's correlation coefficient||||0.4361
71785168|NCT01852110|143069514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.7623|TWO_SIDED|95.0|-1.0|1.37|||Constrained Longitudinal Data Analysis|||||1.37|-1.00|0.7623
71785169|NCT01852110|143069518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.9604|TWO_SIDED|95.0|-2.42|2.54|||Constrained Longitudinal Data Analysis|||||2.54|-2.42|0.9604
71785170|NCT01852110|143069519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.0829|TWO_SIDED|95.0|-0.01|0.22|||Constrained Longitudinal Data Analysis|||||0.22|-0.01|0.0829
71785171|NCT00208091|143069539|SUPERIORITY_OR_OTHER||||||=|0.06||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.06
71785172|NCT00208091|143069540|SUPERIORITY_OR_OTHER||||||=|0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.23
71785173|NCT04677374|143069547|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
71785174|NCT04677374|143069547|OTHER|||||||0.259|||||||Test of proportions|||||||0.259
71785175|NCT04677374|143069547|OTHER|||||||0.044|||||||Test of proportions|||||||0.044
71785176|NCT04677374|143069548|OTHER||Hazard Ratio (HR)|2.23|||||TWO_SIDED|95.0|1.01|4.93||||||||4.93|1.01|
71785177|NCT04677374|143069548|OTHER||Hazard Ratio (HR)|1.66|||||TWO_SIDED|95.0|0.69|4.0||||||||4.00|0.69|
71785178|NCT04677374|143069548|OTHER||Hazard Ratio (HR)|2.31|||||TWO_SIDED|95.0|1.0|5.36||||||||5.36|1.00|
71753266|NCT03583099|143009347|SUPERIORITY||Difference in proportion|5.1||||0.16|TWO_SIDED|95.0|-2.1|12.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.3|-2.1|0.16
71753267|NCT03583099|143009348|SUPERIORITY||Difference in proportion|-0.6||||0.82|TWO_SIDED|95.0|-6.4|5.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.1|-6.4|0.82
71753268|NCT03583099|143009349|SUPERIORITY||Difference in proportion|-6.3||||0.06|TWO_SIDED|95.0|-13.0|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-13.0|0.06
71753269|NCT03583099|143009350|SUPERIORITY||Difference in proportion|-2.5||||0.68|TWO_SIDED|95.0|-14.5|9.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||9.5|-14.5|0.68
71753270|NCT03583099|143009351|SUPERIORITY||Difference in proportion|13.3||||0.19|TWO_SIDED|95.0|-6.72|33.38|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||33.38|-6.72|0.19
71753271|NCT03583099|143009352|SUPERIORITY||Difference in proportion|0.85||||0.93|TWO_SIDED|95.0|-17.82|19.52|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||19.52|-17.82|0.93
71753272|NCT03583099|143009353|SUPERIORITY||Difference in proportion|6.83||||0.45|TWO_SIDED|95.0|-10.84|24.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||24.50|-10.84|0.45
71753273|NCT03583099|143009354|SUPERIORITY||Difference in proportion|7.6||||0.41|TWO_SIDED|95.0|-10.58|25.78|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.78|-10.58|0.41
71753274|NCT03583099|143009355|SUPERIORITY||Difference in proportion|1.85||||0.81|TWO_SIDED|95.0|-13.17|16.88|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.88|-13.17|0.81
71785179|NCT01599234|143069559|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.23||||0.22||95.0|-0.59|0.14|||ANCOVA|||The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.||0.14|-0.59|0.220
71753275|NCT03583099|143009356|SUPERIORITY||Difference in proportion|8.01||||0.51|TWO_SIDED|95.0|-15.38|31.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||31.40|-15.38|0.51
71753276|NCT03583099|143009357|SUPERIORITY||Difference in proportion|-10.34||||0.41|TWO_SIDED|95.0|-34.78|14.09|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.09|-34.78|0.41
71785180|NCT01599234|143069560|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.341||||0.231|TWO_SIDED|95.0|0.83|2.167|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.167|0.830|0.231
71785181|NCT01599234|143069561|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.16||||0.857|TWO_SIDED|95.0|-1.94|1.61|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.61|-1.94|0.857
71785182|NCT01599234|143069562|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.07||||0.734|TWO_SIDED|95.0|-0.55|0.4|||ANCOVA|||The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||0.40|-0.55|0.734
71669461|NCT02654054|142855949|SUPERIORITY||LS Mean of Difference|-190.0|STANDARD_ERROR_OF_MEAN|22.59|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71669462|NCT02654054|142855949|SUPERIORITY||LS Mean of Difference|-116.2|STANDARD_ERROR_OF_MEAN|19.7|<|0.001|TWO_SIDED|||||The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.|mixed model repeated measures|||||||< 0.001
71785183|NCT01599234|143069564|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.0||||0.624|TWO_SIDED|95.0|-2.0|1.0|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.0|-2.0|0.624
71785184|NCT01599234|143069565|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.248||||0.27|TWO_SIDED|95.0|0.842|1.849|||Regression, Logistic|||The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.||1.849|0.842|0.270
71785185|NCT01599234|143069566|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.15||||0.867|TWO_SIDED|95.0|-1.95|1.64|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.||1.64|-1.95|0.867
71785186|NCT01599234|143069567|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.215||||0.569|TWO_SIDED|95.0|0.622|2.373|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.||2.373|0.622|0.569
71785187|NCT02033694|143069569|OTHER||Cox Proportional Hazard|1.21||||0.0004|TWO_SIDED|95.0|1.09|1.35|||Regression, Cox|||Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.||1.35|1.09|0.0004
71785188|NCT02033694|143069569|OTHER||Cox Proportional Hazard|1.45|||<|0.0001|TWO_SIDED|95.0|1.3|1.6|||Regression, Cox|||Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.||1.60|1.30|<0.0001
71785189|NCT02033694|143069570|OTHER||Cox Proportional Hazard|2.18|||<|0.0001|TWO_SIDED|95.0|1.48|3.22|||Regression, Cox|||Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 as the independent variable and NC-MACE during 2 years as the outcome.||3.22|1.48|<0.0001
71785190|NCT02033694|143069570|OTHER||Cox Proportional Hazard|4.22|||<|0.0001|TWO_SIDED|95.0|2.39|7.45|||Regression, Cox|||Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm \> 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.||7.45|2.39|<0.0001
71785191|NCT02899988|143069571|SUPERIORITY||Risk Difference (RD)|29.4||||0.009|TWO_SIDED|95.0|16.9|41.9|||Regression, Logistic|||||41.9|16.9|0.009
71785192|NCT02899988|143069571|SUPERIORITY||Risk Difference (RD)|58.8|||<|0.001|TWO_SIDED|95.0|45.3|72.3|||Regression, Logistic|||||72.3|45.3|<0.001
71785193|NCT02899988|143069571|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.7|79.6|||Regression, Logistic|||||79.6|53.7|<0.001
71785194|NCT02899988|143069572|SUPERIORITY||Risk Difference (RD)|15.7||||0.039|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||||25.7|5.7|0.039
71785195|NCT02899988|143069572|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
71785196|NCT02899988|143069572|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||||44.1|18.6|0.007
71785197|NCT02899988|143069573|SUPERIORITY||Risk Difference (RD)|22.49|||<|0.001|TWO_SIDED|95.0|5.62|89.97|||Regression, Logistic|||||89.97|5.62|<0.001
71785198|NCT02899988|143069573|SUPERIORITY||Risk Difference (RD)|74.6|||<|0.001|TWO_SIDED|95.0|62.1|87.0|||Regression, Logistic|||||87.0|62.1|<0.001
71785199|NCT02899988|143069573|SUPERIORITY||Risk Difference (RD)|70.7|||<|0.001|TWO_SIDED|95.0|57.6|83.7|||Regression, Logistic|||||83.7|57.6|<0.001
71836384|NCT04402489|143178450|SUPERIORITY||Least Square Mean Difference vs Placebo|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.072|TWO_SIDED|95.0|-0.08|1.82|||mixed-effect model for repeated measures|||||1.82|-0.08|0.072
71836385|NCT04402489|143178450|SUPERIORITY||Least Square Mean Difference vs Placebo|0.56|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|95.0|-0.4|1.51|||mixed-effect model for repeated measures|||||1.51|-0.4|0.252
71836386|NCT05902793|143178451|NON_INFERIORITY|the non-inferiority margin is 20%|least square means difference|0.89|||||TWO_SIDED|95.0|-14.3|16.07|||||To establish non-inferiority the lower limit of the least square mean difference had to be \> -20%.|||16.07|-14.30|
71836387|NCT05902793|143178453|SUPERIORITY|||||||0.24|||||||ANCOVA|ANCOVA model had fixed effects of treatment arm, center and wound size||||||0.24
71836388|NCT05418296|143178477|SUPERIORITY||||||<|0.46|||||||t-test, 1 sided|||||||<0.46
71836389|NCT05418296|143178478|SUPERIORITY||||||<|0.00314|||||||t-test, 1 sided|||||||<0.00314
71836390|NCT05418296|143178479|SUPERIORITY||||||<|0.066|||||||t-test, 1 sided|||||||<0.066
71836391|NCT05418296|143178480|SUPERIORITY||||||<|0.085|||||||t-test, 1 sided|||||||<0.0850
71836392|NCT05418296|143178481|SUPERIORITY||||||<|0.0716|||||||t-test, 1 sided|||||||<0.0716
71836393|NCT01180634|143178540|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.0715|TWO_SIDED|95.0|0.96|1.84||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.84|0.96|0.0715
71785200|NCT02899988|143069574|SUPERIORITY||Risk Difference (RD)|15.7||||0.041|TWO_SIDED|95.0|5.7|25.7|||Regression, Logistic|||sPGA (0)||25.7|5.7|0.041
71785201|NCT02899988|143069574|SUPERIORITY||Risk Difference (RD)|31.4||||0.007|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.007
71785202|NCT02899988|143069574|SUPERIORITY||Risk Difference (RD)|31.4||||0.008|TWO_SIDED|95.0|18.6|44.1|||Regression, Logistic|||sPGA (0)||44.1|18.6|0.008
71785203|NCT02899988|143069574|SUPERIORITY||Risk Difference (RD)|35.3|||<|0.001|TWO_SIDED|95.0|21.5|49.1|||Regression, Logistic|||sPGA (0/1)||49.1|21.5|<0.001
71836394|NCT01180634|143178541|SUPERIORITY||LSMean difference|1.41||||0.0213|TWO_SIDED|95.0|0.21|2.6|||Repeared Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.60|0.21|0.0213
71836395|NCT01180634|143178542|SUPERIORITY||LSMean difference|-0.63||||0.0002|TWO_SIDED|95.0|-0.95|-0.3|||Repeated Measures Model||Estimates are determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||-0.30|-0.95|0.0002
71836396|NCT01180634|143178543|SUPERIORITY||LSMean difference|0.28||||0.8335|TWO_SIDED|95.0|-2.3|2.85|||Repeated Measures Model||Estimates were determined from a repeated measures model with terms for treatment, visit, treatment\*visit, region (US, non-US), age (12 to 18 years, \> 18 years), Baseline FEV1 (\<55%, ≥ 55%), and Baseline value.|||2.85|-2.30|0.8335
71669463|NCT00273182|142855950|SUPERIORITY_OR_OTHER||Overall survival rate at 36 month|71.0|||||TWO_SIDED|95.0|68.6|73.2||No p values for the analysis.|Kaplan-Meier (product limit) estimates|Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates.|The estimate is the overall survival rate at 36 month. left-truncation methods were used in the survival analysis for previously implanted subjects.|For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.||73.2|68.6|
71785204|NCT02899988|143069574|SUPERIORITY||Risk Difference (RD)|68.7|||<|0.001|TWO_SIDED|95.0|55.6|81.7|||Regression, Logistic|||sPGA (0/1)||81.7|55.6|<0.001
71785205|NCT02899988|143069574|SUPERIORITY||Risk Difference (RD)|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Regression, Logistic|||sPGA (0/1)||80.0|53.4|<0.001
71785206|NCT02899988|143069575|SUPERIORITY||Mean Difference (Net)|-26.84|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785207|NCT02899988|143069575|SUPERIORITY||Mean Difference (Net)|-37.99|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71836397|NCT01180634|143178544|SUPERIORITY||LSMean difference|2.42||||0.0122|TWO_SIDED|95.0|0.53|4.31|||Repeated Measures Model|||||4.31|0.53|0.0122
71836398|NCT01180634|143178545|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3|TWO_SIDED|95.0|0.6|1.12||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||1.12|0.60|0.3000
71836399|NCT01180634|143178546|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.47|2.04||P-value is determined using a log-rank test stratified by region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|Log Rank||Hazard ratio is obtained from a Cox proportional hazards regression model adjusting for region (US, non-US), age (12-18 years, \>18 years), and baseline FEV1 (\<55%, \>=55%).|||2.04|0.47|0.8670
71669464|NCT00273182|142855950|SUPERIORITY_OR_OTHER||Cause specific survival rate at 36 month|85.3|||||TWO_SIDED|95.0|83.3|87.1||No p value for this analysis.|Kaplan-Meier (product limit) estimates|Cause specific survival rate at 36 month.|left-truncation methods were used in the survival analysis for previously implanted subjects.|For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.||87.1|83.3|
71836400|NCT04419168|143178559|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.57|TWO_SIDED|95.0|-1.3|2.37|||Mixed Models Analysis|||||2.37|-1.30|.57
71836401|NCT04419168|143178560|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|95.0|-0.46|0.61|||Mixed Models Analysis|||||0.61|-0.46|0.79
71836402|NCT04419168|143178561|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.75|TWO_SIDED|95.0|-1.55|1.12|||Mixed Models Analysis|||||1.12|-1.55|0.75
71836403|NCT04419168|143178562|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.31|TWO_SIDED|95.0|-0.6|1.87|||Mixed Models Analysis|||||1.87|-0.60|0.31
71836404|NCT04419168|143178563|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.91|TWO_SIDED|95.0|-1.77|1.99|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||1.99|-1.77|0.91
71753277|NCT03583099|143009358|SUPERIORITY||Difference in proportion|-3.94||||0.76|TWO_SIDED|95.0|-31.03|23.16|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.16|-31.03|0.76
71836405|NCT04419168|143178563|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.05|TWO_SIDED|95.0|-0.03|3.46|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.46|-0.03|0.05
71836406|NCT04419168|143178564|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.12|TWO_SIDED|95.0|-0.31|2.56|||Mixed Models Analysis|||||2.56|-0.31|0.12
71836407|NCT04419168|143178565|SUPERIORITY||Mean Difference (Final Values)|-0.0024||||0.91|TWO_SIDED|95.0|-0.0443|0.0395|||Mixed Models Analysis|||||0.0395|-0.0443|0.91
71836408|NCT04419168|143178566|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.68|TWO_SIDED|95.0|-1.61|2.48|||Mixed Models Analysis|||||2.48|-1.61|0.68
71836409|NCT04419168|143178567|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.75|TWO_SIDED|95.0|-0.46|0.63|||Mixed Models Analysis|||||0.63|-0.46|0.75
71836410|NCT04419168|143178568|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.14|TWO_SIDED|95.0|-2.56|0.35|||Mixed Models Analysis|||||0.35|-2.56|0.14
71836411|NCT04419168|143178569|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.75|TWO_SIDED|95.0|-1.69|1.21|||Mixed Models Analysis|||||1.21|-1.69|0.75
71836412|NCT04419168|143178570|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.49|TWO_SIDED|95.0|-1.3|2.71|||Mixed Models Analysis|||These results correspond to ASCQ-Me Social Functioning Impact only.||2.71|-1.30|0.49
71836413|NCT04419168|143178570|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.037|TWO_SIDED|95.0|0.12|3.88|||Mixed Models Analysis|||These results correspond to ASCQ-Me Emotional Impact only.||3.88|0.12|0.037
71836414|NCT04419168|143178571|SUPERIORITY||Mean Difference (Final Values)|2.13||||0.008|TWO_SIDED|95.0|0.56|3.71|||Mixed Models Analysis|||||3.71|0.56|0.008
71836415|NCT04419168|143178572|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.56|TWO_SIDED|95.0|-1.51|0.82|||Mixed Models Analysis|||||0.82|-1.51|0.56
71836416|NCT04419168|143178573|SUPERIORITY||Mean Difference (Final Values)|-0.0013||||0.95|TWO_SIDED|95.0|-0.0464|0.0437|||Mixed Models Analysis|||||0.0437|-0.0464|0.95
71836417|NCT04419168|143178574|SUPERIORITY||Incidence Rate Ratio|1.11||||0.49|TWO_SIDED|95.0|0.83|1.48|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||1.48|0.83|0.49
71836418|NCT04419168|143178575|SUPERIORITY||Incidence Rate Ratio|1.43||||0.1|TWO_SIDED|95.0|0.93|2.18|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.18|0.93|0.10
71836419|NCT04419168|143178576|SUPERIORITY||Incidence Rate Ratio|1.31||||0.22|TWO_SIDED|95.0|0.85|2.03|||Negative Binomial Regression|Adjustments were made for clinic site, baseline depression (high vs low), and corresponding health care use in the 12 months prior to study entry.||||2.03|0.85|0.22
71836420|NCT04490915|143178577|SUPERIORITY||LS Mean Difference|-17.022|STANDARD_ERROR_OF_MEAN|3.433|<|0.0001|TWO_SIDED|95.0|-23.802|-10.243|||ANCOVA||LS Mean Difference of Crinecerfont - Placebo|||-10.243|-23.802|<0.0001
71836421|NCT05009251|143178589|SUPERIORITY|||||||0.054|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to Reminder Control patients who were sent messages that did not disclose their risk status. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate vs. messages that do not disclose risk status; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||.054
71836422|NCT05009251|143178589|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||This analysis compared groups that were informed they were high risk (High Risk Only, High Risk Based on Medical Records, High Risk Based on Algorithm) to No-Contact Control patients who were not sent messages. Null hypothesis: messages that inform patients they are high risk do not increase flu vaccination rate relative to no messages; Alternative hypothesis: messages that inform patients they are high risk increase flu vaccination rate.||||<.001
71753278|NCT03583099|143009359|SUPERIORITY||Difference in proportion|-0.76||||0.95|TWO_SIDED|95.0|-25.36|23.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||23.83|-25.36|0.95
71753279|NCT03583099|143009360|SUPERIORITY||Difference in means|-0.32||||0.55|TWO_SIDED|95.0|-2.01|1.36||The p-value is adjusted for baseline CAT score.|Mixed Models Analysis||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.36|-2.01|0.55
71753280|NCT03583099|143009361|SUPERIORITY||Difference in proportion|8.7||||0.05|TWO_SIDED|95.0|-0.1|17.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.4|-0.1|0.05
71753281|NCT03583099|143009362|SUPERIORITY||Difference in proportion|1.81||||0.88|TWO_SIDED|95.0|-21.47|25.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.08|-21.47|0.88
71753282|NCT03583099|143009363|SUPERIORITY||Difference in proportion|-5.62||||0.53|TWO_SIDED|95.0|-23.21|11.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.97|-23.21|0.53
71753283|NCT03583099|143009364|SUPERIORITY||Difference in proportion|10.68||||0.24|TWO_SIDED|95.0|-7.27|28.63|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education|||28.63|-7.27|0.24
71753284|NCT03583099|143009365|SUPERIORITY||Difference in proportion|-13.55||||0.19|TWO_SIDED|95.0|-33.65|6.55|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.55|-33.65|0.19
71753285|NCT03583099|143009366|SUPERIORITY||Difference in proportion|0.38||||0.95|TWO_SIDED|95.0|-12.5|13.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.27|-12.50|0.95
71753286|NCT03583099|143009367|SUPERIORITY||Difference in proportion|-6.97||||0.14|TWO_SIDED|95.0|-16.12|2.17|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.17|-16.12|0.14
71753287|NCT03583099|143009368|SUPERIORITY||Difference in proportion|-1.06||||0.87|TWO_SIDED|95.0|-13.39|11.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.27|-13.39|0.87
71753288|NCT03583099|143009369|SUPERIORITY||Difference in proportion|-1.8||||0.81|TWO_SIDED|95.0|-15.9|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-15.9|0.81
71753289|NCT03583099|143009370|SUPERIORITY||Difference in proportion|2.3||||0.63|TWO_SIDED|95.0|-7.2|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-7.2|0.63
71753290|NCT03583099|143009371|SUPERIORITY||Difference in proportion|5.8||||0.17|TWO_SIDED|95.0|-2.5|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-2.5|0.17
71753291|NCT03583099|143009372|SUPERIORITY||Difference in proportion|-2.9||||0.58|TWO_SIDED|95.0|-13.0|7.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.3|-13.0|0.58
71753292|NCT03583099|143009373|SUPERIORITY||Difference in proportion|-0.6||||0.89|TWO_SIDED|95.0|-8.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-8.3|0.89
71753293|NCT03583099|143009374|SUPERIORITY||Difference in proportion|-3.9||||0.16|TWO_SIDED|95.0|-9.2|1.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.5|-9.2|0.16
71785208|NCT02899988|143069575|SUPERIORITY||Mean Difference (Net)|-29.32|STANDARD_ERROR_OF_MEAN|3.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785209|NCT02899988|143069576|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785210|NCT02899988|143069576|SUPERIORITY||Mean Difference (Net)|2.56|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785211|NCT02899988|143069576|SUPERIORITY||Mean Difference (Net)|2.47|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785212|NCT02899988|143069577|SUPERIORITY||Mean Difference (Net)|-8.12|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785213|NCT02899988|143069577|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785214|NCT02899988|143069577|SUPERIORITY||Mean Difference (Net)|-8.57|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71785215|NCT02899988|143069578|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.24||0.009|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.009
71785216|NCT02899988|143069578|SUPERIORITY||Mean Difference (Net)|2.74|STANDARD_ERROR_OF_MEAN|1.22||0.002|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.002
71785217|NCT02899988|143069578|SUPERIORITY||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.24||0.087|TWO_SIDED||||||ANCOVA|||Mental Component Summary (MCS)||||0.087
71669465|NCT00273182|142855954|SUPERIORITY_OR_OTHER||event free rate|89.8|||||TWO_SIDED|95.0|88.3|91.2||No p value for this analysis.|Kaplan-Meier (product limit) estimate|||Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.||91.2|88.3|
71669466|NCT00420420|142855955|SUPERIORITY_OR_OTHER|||||||0.283||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.283
71669467|NCT00420420|142855956|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at week 4||||0.180
71669468|NCT00420420|142855957|SUPERIORITY_OR_OTHER|||||||0.716||95.0||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4||||0.716
71669469|NCT00856492|142855961|SUPERIORITY_OR_OTHER|||||||0.019|||||||Chi-squared|||||||0.019
71669470|NCT00856492|142855962|SUPERIORITY_OR_OTHER|||||||0.64|||||||Log Rank|||||||0.64
71669471|NCT00856492|142855963|SUPERIORITY_OR_OTHER|||||||0.71|||||||Log Rank|||||||0.71
71669472|NCT00868530|142855980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.120
71669473|NCT05411991|142855986|SUPERIORITY||Net treatment benefit|10.5||||0.357|TWO_SIDED|95.0|-11.9|31.9|||General pairwaise comparison|||||31.9|-11.9|0.357
71669474|NCT03848715|142856018|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||.16
71669475|NCT05842967|142856039|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.57|||||TWO_SIDED|95.0|1.396|1.759|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV A.|||1.759|1.396|
71669476|NCT05842967|142856039|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|GMR|1.52|||||TWO_SIDED|95.0|1.333|1.725|||||GMRs (ratio of GMTs from C3671023 SSA to C3671013 immunogenicity subset), 2-sided CI were calculated by exponentiating difference in LS means, corresponding CIs based on regression model. Data reported here is for RSV B.|||1.725|1.333|
71785218|NCT02899988|143069578|SUPERIORITY||Mean Difference (Net)|3.35|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
71669477|NCT05842967|142856040|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|5.1|||||TWO_SIDED|95.0|1.2|9.2|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV A.|||9.2|1.2|
71669478|NCT05842967|142856040|NON_INFERIORITY|Noninferiority was declared if both the null hypothesis of GMR and the null hypothesis of difference in seroresponse rates were rejected for both RSV A and RSV B serum NTs, with a type I error (2-sided) of 5%.|Difference in percentage|8.3|||||TWO_SIDED|95.0|4.2|12.6|||||Difference (C3671023 SSA, compared to C3671013 immunogenicity subset) in proportions, expressed as a percentage; 95% CIs for percentage difference were calculated using exact method based on Miettinen and Nurminen. Data reported here is for RSV B.|||12.6|4.2|
71669479|NCT06192589|142856064|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.43|||<|0.01|TWO_SIDED|90.0|1.34|1.52||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.52|1.34|<0.01
71669480|NCT06192589|142856065|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12|||<|0.01|TWO_SIDED|90.0|1.06|1.17||Analyses are not adjusted for multiplicity.|Mixed Models Analysis||Comparison was the effect of cannabidiol on citalopram compared to citalopram alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.06|<0.01
71669481|NCT06192589|142856066|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.06||||0.34|TWO_SIDED|90.0|0.96|1.16|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.16|0.96|0.34
71669482|NCT06192589|142856066|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.1|TWO_SIDED|90.0|1.0|1.26|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.26|1.00|0.10
71785219|NCT02899988|143069578|SUPERIORITY||Mean Difference (Net)|3.16|STANDARD_ERROR_OF_MEAN|1.18|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
71785220|NCT02899988|143069578|SUPERIORITY||Mean Difference (Net)|3.86|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||ANCOVA|||Physical Component Summary||||<0.001
71753294|NCT03583099|143009375|SUPERIORITY||Difference in proportion|-2.2||||0.62|TWO_SIDED|95.0|-10.9|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-10.9|0.62
71753295|NCT03583099|143009376|SUPERIORITY||Difference in proportion|-1.64||||0.84|TWO_SIDED|95.0|-17.27|13.99|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.99|-17.27|0.84
71753296|NCT03583099|143009377|SUPERIORITY||Difference in proportion|6.09||||0.27|TWO_SIDED|95.0|-4.63|16.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.80|-4.63|0.27
71753297|NCT03583099|143009378|SUPERIORITY||Difference in proportion|2.91||||0.55|TWO_SIDED|95.0|-6.59|12.41|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.41|-6.59|0.55
71753298|NCT03583099|143009379|SUPERIORITY||Difference in proportion|2.37||||0.69|TWO_SIDED|95.0|-9.09|13.83|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.83|-9.09|0.69
71753299|NCT03583099|143009380|SUPERIORITY||Difference in proportion|0.36||||0.93|TWO_SIDED|95.0|-8.13|8.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.85|-8.13|0.93
71753300|NCT03583099|143009381|SUPERIORITY||Difference in proportion|-4.01||||0.26|TWO_SIDED|95.0|-10.97|2.95|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.95|-10.97|0.26
71753301|NCT03583099|143009382|SUPERIORITY||Difference in proportion|-2.04||||0.74|TWO_SIDED|95.0|-14.28|10.21|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.21|-14.28|0.74
71785221|NCT05025241|143069600|OTHER||||||<|0.0001|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||<0.0001
71785222|NCT05025241|143069601|OTHER|||||||0.0003|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0003
71891871|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-47.3|||||TWO_SIDED|95.0|-53.0|-41.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.7|-53.0|
71753302|NCT03583099|143009383|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
71753303|NCT03583099|143009384|SUPERIORITY||Difference in proportion|2.6||||0.46|TWO_SIDED|95.0|-4.3|9.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.6|-4.3|0.46
71753304|NCT03583099|143009385|SUPERIORITY||Difference in proportion|1.5||||0.5|TWO_SIDED|95.0|-3.0|6.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.1|-3.0|0.50
71753305|NCT03583099|143009386|SUPERIORITY||Difference in proportion|-0.2||||0.96|TWO_SIDED|95.0|-6.8|6.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.5|-6.8|0.96
71753306|NCT03583099|143009387|SUPERIORITY||Difference in proportion|2.2||||0.4|TWO_SIDED|95.0|-3.0|7.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.5|-3.0|0.40
71753307|NCT03583099|143009388|SUPERIORITY||Difference in proportion|-0.1||||0.96|TWO_SIDED|95.0|-4.3|4.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.0|-4.3|0.96
71753308|NCT03583099|143009389|SUPERIORITY||Difference in proportion|0.1||||0.98|TWO_SIDED|95.0|-7.9|8.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.1|-7.9|0.98
71753309|NCT03583099|143009390|SUPERIORITY||Difference in proportion|-4.2||||0.46|TWO_SIDED|95.0|-15.2|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-15.2|0.46
71785223|NCT05025241|143069602|OTHER|Change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
71785224|NCT05025241|143069603|OTHER|Change from baseline||||||0.0005|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0005
71785225|NCT05025241|143069604|OTHER|||||||0.0647|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0647
71785226|NCT05025241|143069605|OTHER|Change from baseline||||||0.0984|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0984
71836423|NCT05009251|143178589|SUPERIORITY|||||||0.24|||||||Regression, Linear|||This analysis compared groups who received messages including risk reasons (High Risk Based on Medical Records, High Risk Based on Algorithm) to messages that mentioned patients' risk status but do not include reasons (High Risk Only). Null hypothesis: messages that include risk reasons do not increase flu vaccination rate relative to high-risk messages that do not include risk reasons; Alternative hypothesis: messages including risk reasons are more effective at increasing vaccination rates.||||.240
71891872|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-43.1|||||TWO_SIDED|95.0|-49.6|-36.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.6|-49.6|
71891873|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-41.3|||||TWO_SIDED|95.0|-46.4|-36.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-36.2|-46.4|
71669483|NCT06192589|142856067|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.19||||0.02|TWO_SIDED|90.0|1.05|1.35|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.35|1.05|0.02
71891874|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.8|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.8|
71891875|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-33.9|||||TWO_SIDED|95.0|-39.7|-28.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-28.0|-39.7|
71785227|NCT05025241|143069606|OTHER|Change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
71753310|NCT03583099|143009391|SUPERIORITY||Difference in proportion|3.9||||0.37|TWO_SIDED|95.0|-4.7|12.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.4|-4.7|0.37
71753311|NCT03583099|143009392|SUPERIORITY||Difference in proportion|-0.8||||0.75|TWO_SIDED|95.0|-6.0|4.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.4|-6.0|0.75
71753312|NCT03583099|143009393|SUPERIORITY||Difference in proportion|-8.7||||0.08|TWO_SIDED|95.0|-18.3|0.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.9|-18.3|0.08
71753313|NCT03583099|143009394|SUPERIORITY||Difference in proportion|-4.8||||0.11|TWO_SIDED|95.0|-10.6|1.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.1|-10.6|0.11
71753314|NCT03583099|143009395|SUPERIORITY||Difference in proportion|0.4||||0.89|TWO_SIDED|95.0|-5.1|5.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.9|-5.1|0.89
71753315|NCT03583099|143009396|SUPERIORITY||Difference in proportion|-8.8||||0.05|TWO_SIDED|95.0|-17.5|0.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.0|-17.5|0.05
71753316|NCT03583099|143009397|SUPERIORITY||Difference in proportion|16.76||||0.09|TWO_SIDED|95.0|-2.89|36.42|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||36.42|-2.89|0.09
71753317|NCT03583099|143009398|SUPERIORITY||Difference in proportion|3.7||||0.56|TWO_SIDED|95.0|-8.6|15.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.9|-8.6|0.56
71753318|NCT03583099|143009399|SUPERIORITY||Difference in proportion|10.41||||0.49|TWO_SIDED|95.0|-19.39|40.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||40.20|-19.39|0.49
71785228|NCT05025241|143069607|OTHER|Change from baseline||||||0.0191|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0191
71753319|NCT03583099|143009400|SUPERIORITY||Difference in proportion|10.8||||0.06|TWO_SIDED|95.0|-0.5|22.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||22.1|-0.5|0.06
71753320|NCT03583099|143009401|SUPERIORITY||Difference in proportion|0.41||||0.94|TWO_SIDED|95.0|-10.97|11.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.79|-10.97|0.94
71753321|NCT03583099|143009402|SUPERIORITY||Difference in proportion|2.7||||0.57|TWO_SIDED|95.0|-6.5|11.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.8|-6.5|0.57
71753322|NCT03583099|143009403|SUPERIORITY||Difference in proportion|1.36||||0.89|TWO_SIDED|95.0|-18.01|20.73|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||20.73|-18.01|0.89
71753323|NCT03583099|143009404|SUPERIORITY||Difference in proportion|-2.2||||0.65|TWO_SIDED|95.0|-12.1|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-12.1|0.65
71753324|NCT03583099|143009405|SUPERIORITY||Difference in proportion|12.48||||0.16|TWO_SIDED|95.0|-5.0|29.96|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||29.96|-5.00|0.16
71753325|NCT03583099|143009406|SUPERIORITY||Difference in proportion|4.3||||0.29|TWO_SIDED|95.0|-3.6|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-3.6|0.29
71753326|NCT03583099|143009407|SUPERIORITY||Difference in proportion|5.28||||0.44|TWO_SIDED|95.0|-8.07|18.62|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.62|-8.07|0.44
71753327|NCT03583099|143009408|SUPERIORITY||Difference in proportion|-1.5||||0.62|TWO_SIDED|95.0|-7.6|4.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.5|-7.6|0.62
71785229|NCT05025241|143069608|OTHER|change from baseline||||||0.0013|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0013
71753328|NCT03583099|143009409|SUPERIORITY||Difference in proportion|-7.1||||0.39|TWO_SIDED|95.0|-23.18|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-23.18|0.39
71753329|NCT03583099|143009410|SUPERIORITY||Difference in proportion|-6.6||||0.08|TWO_SIDED|95.0|-13.9|0.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.8|-13.9|0.08
71753330|NCT03583099|143009411|SUPERIORITY||Difference in proportion|-11.3||||0.23|TWO_SIDED|95.0|-29.06|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.00|-29.06|0.23
71785230|NCT05025241|143069609|OTHER|change from baseline||||||0.171|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1710
71669484|NCT06192589|142856067|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.29|TWO_SIDED|90.0|0.94|1.3|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.30|0.94|0.29
71669485|NCT06192589|142856074|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.01||||0.47|TWO_SIDED|90.0|0.98|1.05|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.05|0.98|0.47
71753331|NCT03583099|143009412|SUPERIORITY||Difference in means|-1.14||||0.97|TWO_SIDED|95.0|-6.42|4.13||The p-value adjusts for baseline CAT score.|Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.13|-6.42|0.97
71753332|NCT03583099|143009413|SUPERIORITY||Difference in means|-0.003||||0.47|TWO_SIDED|95.0|-1.86|1.85|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.85|-1.86|0.47
71753333|NCT03583099|143009414|SUPERIORITY||Difference in proportion|17.84||||0.02|TWO_SIDED|95.0|2.34|33.34|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||33.34|2.34|0.02
71753334|NCT03583099|143009415|SUPERIORITY||Difference in proportion|7.8||||0.12|TWO_SIDED|95.0|-2.0|17.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.6|-2.0|0.12
71753335|NCT03583099|143009416|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test. This test is appropriate since only one outcome per practice was seen.||||||1.0
71753336|NCT03583099|143009417|SUPERIORITY||Difference in proportion|2.06||||0.87|TWO_SIDED|95.0|-22.67|26.79|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||26.79|-22.67|0.87
71785231|NCT05025241|143069610|OTHER|change from baseline||||||0.0066|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0066
71785232|NCT05025241|143069611|OTHER|change form baseline||||||0.1094|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.1094
71785233|NCT05025241|143069612|OTHER|change from baseline||||||0.0156|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0156
71753337|NCT03583099|143009418|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71753338|NCT03583099|143009419|SUPERIORITY||Difference in proportion|-5.53||||0.56|TWO_SIDED|95.0|-24.33|13.28|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.28|-24.33|0.56
71753339|NCT03583099|143009420|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71753340|NCT03583099|143009421|SUPERIORITY||Difference in proportion|12.66||||0.21|TWO_SIDED|95.0|-7.05|32.37|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||32.37|-7.05|0.21
71753341|NCT03583099|143009422|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71753342|NCT03583099|143009423|SUPERIORITY||Difference in proportion|-18.29||||0.08|TWO_SIDED|95.0|-38.66|2.08|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.08|-38.66|0.08
71753343|NCT03583099|143009424|SUPERIORITY|||||||1|||||||Fisher Exact|The p-value is calculated from a two-sided Fisher's exact test.||||||1.0
71753344|NCT03583099|143009425|SUPERIORITY||Difference in proportion|-0.67||||0.92|TWO_SIDED|95.0|-14.06|12.71|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.71|-14.06|0.92
71753345|NCT03583099|143009427|SUPERIORITY||Difference in proportion|-5.47||||0.29|TWO_SIDED|95.0|-15.72|4.77|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||4.77|-15.72|0.29
71669486|NCT06192589|142856074|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.99||||0.73|TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.03|0.96|0.73
71785234|NCT05025241|143069613|OTHER|change from baseline||||||0.0326|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period. Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants||||0.0326
71785235|NCT02984709|143069642|SUPERIORITY||Estimated Mean Difference|-0.17||||0.593|TWO_SIDED|95.0|-0.81|0.47||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.47|-0.81|0.593
71785236|NCT02984709|143069643|SUPERIORITY||Estimated Mean Difference|-1.137||||0.581|TWO_SIDED|95.0|-5.27|2.99||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||2.99|-5.27|0.581
71785237|NCT02984709|143069644|SUPERIORITY||Estimated Mean Difference|-0.587||||0.206|TWO_SIDED|95.0|-1.52|0.34||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||0.34|-1.52|0.206
71669487|NCT06192589|142856075|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.12||||0.03|TWO_SIDED|90.0|1.03|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.03|0.03
71785238|NCT02984709|143069645|SUPERIORITY||Estimated Mean Difference|-2.494||||0.511|TWO_SIDED|95.0|-10.11|5.13||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Child-reported family conflict||5.13|-10.11|0.511
71785239|NCT02984709|143069645|SUPERIORITY||Estimated Mean Difference|-3.354||||0.19|TWO_SIDED|95.0|-8.44|1.73||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Parent-reported family conflict||1.73|-8.44|0.190
71785240|NCT02984709|143069646|SUPERIORITY||Estimated Mean Difference|0.396||||0.873|TWO_SIDED|95.0|-4.57|5.36||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||5.36|-4.57|0.873
71785241|NCT02984709|143069647|SUPERIORITY||Estimated Mean Difference|2.996||||0.603|TWO_SIDED|95.0|-8.57|14.56||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||||14.56|-8.57|0.603
71785242|NCT02854631|143069672|SUPERIORITY|||||||1|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||1.00
71785243|NCT02854631|143069673|SUPERIORITY|||||||0.061|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.061
71785244|NCT02854631|143069674|SUPERIORITY|||||||0.06|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.||||||0.060
71785245|NCT02854631|143069675|SUPERIORITY|||||||0.22||||||P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|Fisher Exact|||||||0.22
71785246|NCT02854631|143069691|SUPERIORITY|||||||0.3|||||||Fisher Exact|Fisher's exact test (2-sided) was used to explore differences between groups in the percentage of participants with response/non-response.||||||0.30
71785247|NCT04774328|143069733|OTHER|Analysis of Variance (ANOVA)|Median Difference (Final Values)|-39.28|STANDARD_ERROR_OF_MEAN|54.818||0.4812|TWO_SIDED|95.0|-152.97|74.4|||ANOVA|||||74.40|-152.97|0.4812
71785248|NCT04774328|143069734|OTHER|ANOVA|Mean Difference (Final Values)|-158.08|STANDARD_ERROR_OF_MEAN|64.232||0.0222|TWO_SIDED|95.0|-291.29|-24.87|||ANOVA|||"Applies to evoked measure of after coughing."||-24.87|-291.29|0.0222
71785249|NCT04774328|143069734|OTHER|ANOVA|Mean Difference (Final Values)|-55.04|STANDARD_ERROR_OF_MEAN|43.19||0.2158|TWO_SIDED|95.0|-144.61|34.53|||ANOVA|||"Applies to evoked measure for after sitting up."||34.53|-144.61|0.2158
71785250|NCT04774328|143069734|OTHER|ANOVA|Mean Difference (Final Values)|-78.73|STANDARD_ERROR_OF_MEAN|42.532||0.0777|TWO_SIDED|95.0|-166.93|9.48|||ANOVA|||"Applies to evoked measure of after ambulation."||9.48|-166.93|0.0777
71785251|NCT04774328|143069735|OTHER|ANOVA|Mean Difference (Final Values)|-9.375|STANDARD_ERROR_OF_MEAN|12.7245||0.469|TWO_SIDED|95.0|-35.764|17.014|||ANOVA|||Entry applies to OC 0-96 hours.||17.014|-35.764|0.4690
71785252|NCT04774328|143069735|OTHER|ANOVA|Mean Difference (Final Values)|-8.125|STANDARD_ERROR_OF_MEAN|14.5059||0.5811|TWO_SIDED|95.0|-38.208|21.958|||ANOVA|||Applies to OC 0 - Day 8.||21.958|-38.208|0.5811
71785253|NCT00357968|143069751|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.21|||<|0.0001|TWO_SIDED|95.0|38.04|48.38|||ANCOVA|||||48.38|38.04|<0.0001
71785254|NCT00357968|143069752|SUPERIORITY_OR_OTHER||LS Mean difference|14.93|||<|0.0001|TWO_SIDED|95.0|10.6|19.26|||Mixed Models Analysis|||||19.26|10.6|<0.0001
71785255|NCT00357968|143069753|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.75|||<|0.0001|TWO_SIDED|95.0|38.35|51.15|||ANCOVA|||||51.15|38.35|<0.0001
71785256|NCT00357968|143069758|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71669488|NCT06192589|142856075|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|0.98||||0.66|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.06|0.91|0.66
71669489|NCT06192589|142856076|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies.|Geometric mean ratio|1.08||||0.13|TWO_SIDED|90.0|0.99|1.18|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect.||1.18|0.99|0.13
71669490|NCT06192589|142856076|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.26|||<|0.01|TWO_SIDED|90.0|1.17|1.36|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Area under the curve was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.36|1.17|<0.01
71669491|NCT06192589|142856077|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.08||||0.12|TWO_SIDED|90.0|1.0|1.17|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of a single dose of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.17|1.00|0.12
71669492|NCT06192589|142856077|OTHER|A difference in exposure was concluded if the 2-sided 90% CI of the geometric mean ratio excluded 1, which is standard in pharmacokinetic studies|Geometric mean ratio|1.11||||0.07|TWO_SIDED|90.0|1.01|1.21|||Mixed Models Analysis|Analyses are not adjusted for multiplicity.|Comparison was the effect of multiple doses of cannabidiol on morphine compared to morphine alone.|Maximum concentration was log-transformed and the values between groups were compared using a linear mixed effects model with group as a categorical variable and subject as a random effect||1.21|1.01|0.07
71669493|NCT01866826|142856081|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71785257|NCT00357968|143069759|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Fisher Exact|||||||0.0629
71785258|NCT00357968|143069760|SUPERIORITY_OR_OTHER|||||||0.1827||95.0|||||Fisher Exact|||||||0.1827
71785259|NCT00357968|143069761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.3|||<|0.0001|TWO_SIDED|95.0|-61.2|-47.4|||ANCOVA|||||-47.4|-61.2|<0.0001
71785260|NCT00357968|143069762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-60.5|||<|0.0001|TWO_SIDED|95.0|-67.1|-54.0|||ANCOVA|||||-54.0|-67.1|<0.0001
71785261|NCT00357968|143069763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.2|||<|0.0001|TWO_SIDED|95.0|-63.2|-49.2|||ANCOVA|||||-49.2|-63.2|<0.0001
71785262|NCT00357968|143069764|SUPERIORITY_OR_OTHER||LS Mean difference|-20.1|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.5|||Mixed Models Analysis|||||-14.5|-25.7|<0.0001
71785263|NCT00357968|143069765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.7058|TWO_SIDED|95.0|-2.95|2.0|||ANCOVA|||||2.00|-2.95|0.7058
71785264|NCT00357968|143069766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.33||||0.4029|TWO_SIDED|95.0|-4.48|1.82|||ANCOVA|||||1.82|-4.48|0.4029
71785265|NCT00357968|143069767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.7893|TWO_SIDED|95.0|-0.06|0.08|||ANCOVA|||||0.08|-0.06|0.7893
71785266|NCT00357968|143069768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.4528|TWO_SIDED|95.0|-0.25|0.07|||ANCOVA|||||0.07|-0.25|0.4528
71785267|NCT04216329|143069803|OTHER|||||||0.02|||||||Students t-test|||||||0.02
71785268|NCT04216329|143069803|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
71785269|NCT04216329|143069803|OTHER|||||||0.02|||||||Students t-test|||||||0.02
71785270|NCT04216329|143069803|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
71785271|NCT04216329|143069803|OTHER|||||||0.02|||||||Students t-test|||||||0.02
71785272|NCT04216329|143069803|OTHER|||||||0.07||||||P-value 0.07 represents the difference between baseline depression scores and completion of treatment scores.|Students t-test|||||||0.07
71785273|NCT04216329|143069805|OTHER|||||||0.09|||||||Students t-test|||||||0.09
71785274|NCT04216329|143069805|OTHER|||||||0.09|||||||Students t-test|||||||0.09
71785275|NCT04216329|143069805|OTHER|||||||0.09|||||||Students t-test|||||||0.09
71785276|NCT04600921|143069825|SUPERIORITY|The parameters required to calculate sample size were the expected rate of VT/VF episodes/year in the placebo group, the minimal VT/VF rate ratio to be detected in the ertugliflozin group compared with the placebo group, the average follow-up of treatment duration, the negative binomial dispersion parameter, type 1 error probability, and the desired power.|Rate Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.04|0.61||The yearly rate ratio was adjusted for baseline number of sVT/VF episodes.|Negative binomial regression model|A prespecified sensitivity analysis was done to mitigate the effect of outliers by using the robust estimation approaches for negative binomial model.|Ertugliflozin is the numerator and the placebo is the denominator.|We compared the rate of sVT/VF episodes between experimental arms after 52 weeks.The initial sample calculation was based on the mathematical formula provided by Zhu and Lakkis for comparing event rates of two negative binomial distributiuons. To detect a 30% reduction in VT/VF episode rates in the ertugliflozin group compared to placebo group, with 80% power and an alpha level of 0.05, accounting for 5% drop out in each group, a total sample size of 402 was estimated to be required.||0.61|0.04|<0.001
71785277|NCT04600921|143069826|SUPERIORITY||Rate Ratio|0.34|||||TWO_SIDED|95.0|0.12|0.97||||||The number of incident nsVT episodes were analyzed using a beta binomial model.||0.97|0.12|
71785278|NCT04600921|143069827|SUPERIORITY||Rate Ratio|0.47|||||TWO_SIDED|95.0|0.13|1.81||||||The number of appropriate ICD therapies were analyzed by using beta binomial model.||1.81|0.13|
71785279|NCT04600921|143069828|SUPERIORITY||Difference in mean change|0.17|||>|0.05|TWO_SIDED|95.0|-0.35|0.69|||Regression, Linear|||The change in NTproBNP levels was analyzed by using a multiple linear regression model.||0.69|-0.35|>0.05
71785280|NCT04600921|143069829|SUPERIORITY||Mean Difference (Final Values)|0.72|||||TWO_SIDED|95.0|-1.69|3.13||||||The change in HbA1c levels from baseline to week 52 was analyzed by multiple linear regression model.||3.13|-1.69|
71785281|NCT04600921|143069830|SUPERIORITY||Rate Ratio|0.6|||||TWO_SIDED|95.0|0.2|1.7||||||||1.7|0.2|
71785282|NCT03758274|143069839|SUPERIORITY|||||||0.746|||||||Based on simple path model in Mplus.|||||||0.746
71785283|NCT03758274|143069840|SUPERIORITY|||||||0.247|||||||Based on simple path model in Mplus.|||||||0.247
71785284|NCT03758274|143069841|SUPERIORITY|||||||0.689|||||||Chi-squared|||||||0.689
71785285|NCT00410046|143069847|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Admissions to hospital||||1.0
71785286|NCT00410046|143069847|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||Therapeutic warm bath sessions||||0.23
71891876|NCT03193866|143305375|SUPERIORITY||Difference in proportion|-49.8|||||TWO_SIDED|95.0|-58.0|-41.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-41.6|-58.0|
71785287|NCT00410046|143069847|SUPERIORITY_OR_OTHER|||||||0.567|||||||Fisher Exact|||Physiotherapist visits||||0.567
71785288|NCT00410046|143069847|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Out-patient physician visit||||0.475
71785289|NCT00410046|143069848|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANCOVA|One-way ANCOVA, baseline was a covariate.||Inpatient hospitalization days per patient||||0.628
71785290|NCT00410046|143069848|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|||Therapeutic warm bath sessions per patient||||0.045
71785291|NCT00410046|143069848|SUPERIORITY_OR_OTHER|||||||0.361|||||||ANCOVA|||Physiotherapist visits per patient||||0.361
71785292|NCT00410046|143069848|SUPERIORITY_OR_OTHER|||||||0.816|||||||ANCOVA|||Out-patient physician visit per patient||||0.816
71785293|NCT00410046|143069849|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Analysis completed for patients with sick leave during the past 12 months||||1.00
71785294|NCT00410046|143069850|SUPERIORITY_OR_OTHER|||||||0.906|||||||ANCOVA|||||||0.906
71785295|NCT00410046|143069855|SUPERIORITY_OR_OTHER|||||||0.743||||||Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks|Fisher Exact|||||||0.743
71785296|NCT00410046|143069855|SUPERIORITY_OR_OTHER|||||||0.362||||||Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks|Fisher Exact|||Comparison of percentages||||0.362
71785297|NCT00410046|143069855|SUPERIORITY_OR_OTHER|||||||0.005||||||Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks|Fisher Exact|||||||0.005
71785298|NCT00410046|143069855|SUPERIORITY_OR_OTHER|||||||0.091||||||Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks|Fisher Exact|||||||0.091
71785299|NCT00410046|143069856|SUPERIORITY_OR_OTHER|||||||0.576||||||Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment|Fisher Exact|||||||0.576
71785300|NCT00875212|143069861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.001||95.0|||||ANOVA|repeated measure anova|The median value of each parameter (pH baseline, minimal pH) was obtained and these values were compared between each group|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The null hyphothesis was no difference between pH values of the groups. The statistical analysis was by repeated measurements ANOVA.||||0.001
71785301|NCT00875212|143069861|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.5|STANDARD_DEVIATION|0.1||0.001||95.0|||||ANOVA|repeated-measurements ANOVA||The comparison was based on mean and median values of plaque pH in different moments of cariogenic challenge. The null hypothesis was that no diference between the groups wil be found. The test hypothesis was that the experimental dentifrice of CaGP-F would provide a better control of plaque pH after 14 days of use.||||0.001
71785302|NCT00875212|143069862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_DEVIATION|0.25||0.01||95.0|||||ANOVA|repeated measurements ANOVA|The difference of pH values between groups was above 1.0 unit.|The groups were compared by repeated measurements anova. There was no power calculation, but a pilot study to check the minimal number necessary of subjects in order to find a signifcant difference between interventions.||||0.01
71785303|NCT00482612|143069878|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
71785304|NCT00482612|143069878|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
71785305|NCT00482612|143069878|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.||||||<0.0001
71785306|NCT00482612|143069879|SUPERIORITY_OR_OTHER|||||||0.0014|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0014
71785307|NCT00482612|143069879|SUPERIORITY_OR_OTHER|||||||0.0135|||||||ANCOVA|Baseline SL was used as a covariate.||||||0.0135
71785308|NCT00482612|143069879|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Baseline SL was used as a covariate.||||||<0.0001
71785309|NCT04180488|143069933|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.23||||0.0005|TWO_SIDED|95.0|-6.63|-1.84||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an analysis of covariance (ANCOVA) model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.84|-6.63|0.0005
71785310|NCT04180488|143069933|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.87||||0.0449|TWO_SIDED|95.0|-5.68|-0.07||Threshold for significance at 2-sided 0.043 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.07|-5.68|0.0449
71669494|NCT01866826|142856082|SUPERIORITY|||||||||||||||||We calculated the proportion of pts with elevated viral levels \>50 copies/ml at each phase of the study.|We estimated that four of the seven patients would have an elevation in viral Ribonucleic Acid (RNA) level \>50 copies/ml.|||
71669495|NCT01866826|142856084|SUPERIORITY||Mean Difference (Net)|0.7872|||||TWO_SIDED|||||||||We calculated the percentage of total lymphocytes that were expressing activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the Wilcoxon test to detect differences between the differences in percentages in the control and Rifaximin groups.||||
71669496|NCT01866826|142856084|SUPERIORITY|||||||0.54|||||||Wilcoxon|||We calculated the percentage of total lymphocytes that were expressing the activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the T-test to detect differences between the differences in percentages in the control group and Rifaximin groups.||||0.54
71669497|NCT02493660|142856106|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints. The primary analysis method was a multilinear regression model for month 12 success with age (\<65 years, ≥65 years), gender, and treatment as the model covariates for the PP population for noninferiority testing.||||||0.0049|||||||Regression, Logistic|Primary analysis method was for month 12 success with age (\<65 years, ≥65 years), sex, and treatment as the model covariates.||||||0.0049
71669498|NCT02493660|142856109|NON_INFERIORITY|The non-inferiority margin was 10% for all composite endpoints.|||||<|0.05|||||||Regression, Logistic|||Results from logistic regression model.||||<0.05
71669499|NCT02502149|142856143|OTHER||Adjusted Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.24|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.24|0.93|
71836424|NCT05009251|143178589|SUPERIORITY|||||||0.047|||||||Regression, Linear|||Null hypothesis: flu-shot messages that do not mention high-risk status do not increase vaccination relative to no messages; Alternative hypothesis: flu shot messages that do not mention high-risk status increase flu shots relative to no messages.||||.047
71836425|NCT05009251|143178589|SUPERIORITY|||||||0.781||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Medical Records messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Medical Records.||||.781
71836426|NCT05009251|143178589|SUPERIORITY|||||||0.361||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Only and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Only and High Risk Based on Algorithm.||||.361
71669500|NCT02502149|142856144|OTHER||Adjusted Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.87|1.16|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).|||1.16|0.87|
71669501|NCT02222922|142856249|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|79.38||||0.3105|TWO_SIDED|90.0|54.01|116.65|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||116.65|54.01|0.3105
71669502|NCT02222922|142856250|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|77.23||||0.2316|TWO_SIDED|90.0|53.8|110.87|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||110.87|53.80|0.2316
71669503|NCT02222922|142856251|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.97||||0.4264|TWO_SIDED|90.0|60.05|120.22|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||120.22|60.05|0.4264
71669504|NCT02222922|142856252|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.32||||0.5123|TWO_SIDED|90.0|64.03|121.82|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||121.82|64.03|0.5123
71669505|NCT02222922|142856253|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.15||||0.824|TWO_SIDED|90.0|44.79|185.5|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.50|44.79|0.8240
71836427|NCT05009251|143178589|SUPERIORITY|||||||0.77||||||Pairwise comparisons between high-risk messages (Analyses 5, 6 and 7) were analyzed in the same regression. Reported p-values were adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: High Risk Based on Medical Records and High Risk Based on Algorithm messages are equally effective at promoting flu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High Risk Based on Medical Records and High Risk Based on Algorithm.||||.770
71669506|NCT02222922|142856254|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|89.58||||0.7922|TWO_SIDED|90.0|43.94|182.62|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||182.62|43.94|0.7922
71669507|NCT02222922|142856255|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|91.17||||0.824|TWO_SIDED|90.0|44.87|185.25|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||185.25|44.87|0.8240
71669508|NCT02222922|142856256|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|102.31||||0.9553|TWO_SIDED|90.0|51.08|204.9|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||204.90|51.08|0.9553
71669509|NCT02222922|142856257|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|81.14||||0.2951|TWO_SIDED|90.0|57.99|113.54|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||113.54|57.99|0.2951
71669510|NCT02222922|142856258|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|84.02||||0.3769|TWO_SIDED|90.0|60.24|117.19|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||117.19|60.24|0.3769
71753346|NCT03583099|143009429|SUPERIORITY||Difference in proportion|-2.87||||0.69|TWO_SIDED|95.0|-17.14|11.39|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||11.39|-17.14|0.69
71753347|NCT03583099|143009430|SUPERIORITY||Difference in proportion|-13.15||||0.32|TWO_SIDED|95.0|-39.06|12.76|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.76|-39.06|0.32
71753348|NCT03583099|143009431|SUPERIORITY||Difference in proportion|-0.2||||0.98|TWO_SIDED|95.0|-15.5|15.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.0|-15.5|0.98
71753349|NCT03583099|143009433|SUPERIORITY||Difference in proportion|3.1||||0.55|TWO_SIDED|95.0|-7.0|13.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.1|-7.0|0.55
71753350|NCT03583099|143009434|SUPERIORITY||Difference in proportion|-8.61||||0.43|TWO_SIDED|95.0|-30.19|12.97|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.97|-30.19|0.43
71753351|NCT03583099|143009435|SUPERIORITY||Difference in proportion|7.6||||0.1|TWO_SIDED|95.0|-1.4|16.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||16.5|-1.4|0.10
71785311|NCT04180488|143069933|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.54||||0.0184|TWO_SIDED|95.0|-4.65|-0.43||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.43|-4.65|0.0184
71785312|NCT04180488|143069934|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-8.53||||0.0003|TWO_SIDED|95.0|-13.16|-3.9||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-3.90|-13.16|0.0003
71785313|NCT04180488|143069934|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.65||||0.0226|TWO_SIDED|95.0|-8.65|-0.65||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.65|-8.65|0.0226
71785314|NCT04180488|143069935|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-4.38||||0.0003|TWO_SIDED|95.0|-6.78|-1.98||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-1.98|-6.78|0.0003
71785315|NCT04180488|143069935|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.17||||0.0316|TWO_SIDED|95.0|-4.15|-0.19||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.19|-4.15|0.0316
71785316|NCT04180488|143069936|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.413||||0.0014|TWO_SIDED|95.0|1.596|7.299||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test was performed on association between responder status and intervention group, adjusted by baseline disease severity (UAS7\<28,\>=28), presence of angioedema at baseline and region.||7.299|1.596|0.0014
71785317|NCT04180488|143069936|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.507||||0.0109|TWO_SIDED|95.0|1.231|5.107||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||5.107|1.231|0.0109
71785318|NCT04180488|143069937|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.848||||0.0075|TWO_SIDED|95.0|1.301|6.234||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.234|1.301|0.0075
71785319|NCT04180488|143069937|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|3.137||||0.0045|TWO_SIDED|95.0|1.371|7.176||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.176|1.371|0.0045
71836428|NCT05374837|143178597|SUPERIORITY||Odds Ratio (OR)|0.9585||||0.145|TWO_SIDED|95.0|0.4276|2.1485||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in control group at endline.|||2.1485|0.4276|0.145
71785320|NCT04180488|143069938|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.908||||0.0199|TWO_SIDED|95.0|1.173|7.209||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||7.209|1.173|0.0199
71785321|NCT04180488|143069938|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.677||||0.0187|TWO_SIDED|95.0|1.127|6.359||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.359|1.127|0.0187
71785322|NCT04180488|143069939|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|0.93||||0.194|TWO_SIDED|95.0|-0.48|2.34||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||2.34|-0.48|0.1940
71785323|NCT04180488|143069940|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-2.37||||0.0377|TWO_SIDED|95.0|-4.6|-0.13||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.13|-4.60|0.0377
71785324|NCT04180488|143069941|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS Mean Difference|-5.02||||0.0223|TWO_SIDED|95.0|-9.32|-0.72||Threshold for significance at 2-sided 0.05 level.|ANCOVA|||Analyzed by fitting an ANCOVA model with the corresponding baseline value, intervention group, presence of angioedema at baseline, and regions as covariates.||-0.72|-9.32|0.0223
71785325|NCT04180488|143069942|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|2.645||||0.0215|TWO_SIDED|95.0|1.154|6.061||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||6.061|1.154|0.0215
71785326|NCT04180488|143069943|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Odds Ratio (OR)|1.872||||0.0971|TWO_SIDED|95.0|0.893|3.923||Threshold for significance at 2-sided 0.05 level.|Cochran-Mantel-Haenszel|||CMH test was performed on the association between the responder status and intervention group, adjusted by baseline disease severity (UAS7 \<28, \>=28), presence of angioedema at baseline, and region.||3.923|0.893|0.0971
71785327|NCT01104493|143069983|NON_INFERIORITY_OR_EQUIVALENCE|H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference \< 5 percentage points.|rate difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6|||score statistic|||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.||2.6|-5.2|
71785328|NCT03975790|143070001|SUPERIORITY|||||||0.4695|||||||Chi-squared|||||||0.4695
71785329|NCT03975790|143070001|SUPERIORITY|||||||0.7644|||||||Chi-squared|||||||0.7644
71785330|NCT03975790|143070001|SUPERIORITY|||||||0.8316|||||||Chi-squared|||||||0.8316
71785331|NCT03975790|143070002|SUPERIORITY|||||||0.9829|||||||Chi-squared|||||||0.9829
71785332|NCT03975790|143070002|SUPERIORITY|||||||0.8021|||||||Chi-squared|||||||0.8021
71785333|NCT03975790|143070002|SUPERIORITY|||||||0.8376|||||||Chi-squared|||||||0.8376
71785334|NCT03975790|143070003|SUPERIORITY|||||||0.2864|||||||t-test|||||||0.2864
71785335|NCT03975790|143070003|SUPERIORITY|||||||0.1583|||||||t-test|||||||0.1583
71785336|NCT03975790|143070003|SUPERIORITY|||||||0.4546|||||||t-test|||||||0.4546
71785337|NCT03975790|143070004|SUPERIORITY|||||||0.028|||||||t-test|||||||0.0280
71785338|NCT03975790|143070004|SUPERIORITY|||||||0.0106|||||||t-test|||||||0.0106
71785339|NCT03975790|143070004|SUPERIORITY|||||||0.7293|||||||t-test|||||||0.7293
71785340|NCT03975790|143070005|SUPERIORITY|||||||0.9215|||||||Chi-squared|||||||0.9215
71785341|NCT03975790|143070005|SUPERIORITY|||||||0.6078|||||||Chi-squared|||||||0.6078
71785342|NCT03975790|143070005|SUPERIORITY|||||||0.6258|||||||Chi-squared|||||||0.6258
71785343|NCT03975790|143070006|SUPERIORITY|||||||0.3586|||||||Chi-squared|||||||0.3586
71785344|NCT03975790|143070006|SUPERIORITY|||||||0.5117|||||||Chi-squared|||||||0.5117
71785345|NCT03975790|143070007|SUPERIORITY|||||||0.5372|||||||t-test|||||||0.5372
71785346|NCT03975790|143070007|SUPERIORITY|||||||0.6155|||||||t-test|||||||0.6155
71785347|NCT03975790|143070007|SUPERIORITY|||||||0.9696|||||||t-test|||||||0.9696
71785348|NCT03975790|143070008|SUPERIORITY|||||||0.2514|||||||t-test|||||||0.2514
71785349|NCT03975790|143070008|SUPERIORITY|||||||0.9851|||||||t-test|||||||0.9851
71785350|NCT03975790|143070008|SUPERIORITY|||||||0.4309|||||||t-test|||||||0.4309
71785351|NCT03975790|143070009|SUPERIORITY|||||||0.6033|||||||t-test|||||||0.6033
71785352|NCT03975790|143070009|SUPERIORITY|||||||0.348|||||||t-test|||||||0.3480
71785353|NCT03975790|143070009|SUPERIORITY|||||||0.5375|||||||t-test|||||||0.5375
71785354|NCT03975790|143070010|SUPERIORITY|||||||0.0345|||||||Chi-squared|||Other aftercare||||0.0345
71785355|NCT03975790|143070010|SUPERIORITY|||||||0.2316|||||||Chi-squared|||Other aftercare||||0.2316
71785356|NCT03975790|143070010|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other aftercare||||0.7349
71785357|NCT03975790|143070010|SUPERIORITY|||||||0.0774|||||||Chi-squared|||Other connective tissue disease||||0.0774
71785358|NCT03975790|143070010|SUPERIORITY|||||||0.4228|||||||Chi-squared|||Other connective tissue disease||||0.4228
71785359|NCT03975790|143070010|SUPERIORITY|||||||0.0583|||||||Chi-squared|||Other connective tissue disease||||0.0583
71785360|NCT03975790|143070010|SUPERIORITY|||||||0.9683|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9683
71785361|NCT03975790|143070010|SUPERIORITY|||||||0.8877|||||||Chi-squared|||Other non-traumatic joint disorders||||0.8877
71785362|NCT03975790|143070010|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Other non-traumatic joint disorders||||0.9228
71785363|NCT03975790|143070010|SUPERIORITY|||||||0.7661|||||||Chi-squared|||Medical examination/evaluation||||0.7661
71785364|NCT03975790|143070010|SUPERIORITY|||||||0.3034|||||||Chi-squared|||Medical examination/evaluation||||0.3034
71785365|NCT03975790|143070010|SUPERIORITY|||||||0.2765|||||||Chi-squared|||Medical examination/evaluation||||0.2765
71785366|NCT03975790|143070010|SUPERIORITY|||||||0.8652|||||||Chi-squared|||Other suspected conditions||||0.8652
71785367|NCT03975790|143070010|SUPERIORITY|||||||0.2243|||||||Chi-squared|||Other suspected conditions||||0.2243
71785368|NCT03975790|143070010|SUPERIORITY|||||||0.3449|||||||Chi-squared|||Other suspected conditions||||0.3449
71785369|NCT03975790|143070010|SUPERIORITY|||||||0.3529|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.3529
71785370|NCT03975790|143070010|SUPERIORITY|||||||0.1012|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1012
71785371|NCT03975790|143070010|SUPERIORITY|||||||0.4123|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4123
71669511|NCT02222922|142856259|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|86.15||||0.4385|TWO_SIDED|90.0|62.2|119.32|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||119.32|62.20|0.4385
71669512|NCT02222922|142856260|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Geometric Mean Ratio (GMR)|88.75||||0.5678|TWO_SIDED|90.0|62.24|126.56|||ANOVA|||Test: PF-06647020 1.4 mg/kg + Fluconazole(Q3W-DDI) group; Reference: PF-06647020 2.8 mg/kg (Q3W-DDI) group.||126.56|62.24|0.5678
71785372|NCT03975790|143070010|SUPERIORITY|||||||0.2742|||||||Chi-squared|||Osteoarthritis||||0.2742
71785373|NCT03975790|143070010|SUPERIORITY|||||||0.1009|||||||Chi-squared|||Osteoarthritis||||0.1009
71785374|NCT03975790|143070010|SUPERIORITY|||||||0.0318|||||||Chi-squared|||Osteoarthritis||||0.0318
71785375|NCT03975790|143070010|SUPERIORITY|||||||0.4808|||||||Chi-squared|||Essential hypertension||||0.4808
71785376|NCT03975790|143070010|SUPERIORITY|||||||0.0778|||||||Chi-squared|||Essential hypertension||||0.0778
71785377|NCT03975790|143070010|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Essential hypertension||||0.2871
71785378|NCT03975790|143070010|SUPERIORITY|||||||0.7356|||||||Chi-squared|||Residual codes; unclassified||||0.7356
71785379|NCT03975790|143070010|SUPERIORITY|||||||0.4975|||||||Chi-squared|||Residual codes; unclassified||||0.4975
71785380|NCT03975790|143070010|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
71785381|NCT03975790|143070010|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Disorders of lipid metabolism||||0.3559
71785382|NCT03975790|143070010|SUPERIORITY|||||||0.7725|||||||Chi-squared|||Disorders of lipid metabolism||||0.7725
71785383|NCT03975790|143070010|SUPERIORITY|||||||0.3875|||||||Chi-squared|||Disorders of lipid metabolism||||0.3875
71785384|NCT03975790|143070010|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Back problems||||0.0225
71785385|NCT03975790|143070010|SUPERIORITY|||||||0.4427|||||||Chi-squared|||Back problems||||0.4427
71785386|NCT03975790|143070010|SUPERIORITY|||||||0.4094|||||||Chi-squared|||Back problems||||0.4094
71785387|NCT03975790|143070010|SUPERIORITY|||||||0.8775|||||||Chi-squared|||Other upper respiratory infections||||0.8775
71785388|NCT03975790|143070010|SUPERIORITY|||||||0.3525|||||||Chi-squared|||Other upper respiratory infections||||0.3525
71785389|NCT03975790|143070010|SUPERIORITY|||||||0.4724|||||||Chi-squared|||Other upper respiratory infections||||0.4724
71785390|NCT03975790|143070010|SUPERIORITY|||||||0.717|||||||Chi-squared|||Other lower respiratory disease||||0.7170
71785391|NCT03975790|143070010|SUPERIORITY|||||||0.2909|||||||Chi-squared|||Other lower respiratory disease||||0.2909
71785392|NCT03975790|143070010|SUPERIORITY|||||||0.5057|||||||Chi-squared|||Other lower respiratory disease||||0.5057
71785393|NCT03975790|143070010|SUPERIORITY|||||||0.2613|||||||Chi-squared|||Other nervous system disorders||||0.2613
71785394|NCT03975790|143070010|SUPERIORITY|||||||0.9901|||||||Chi-squared|||Other nervous system disorders||||0.9901
71785395|NCT03975790|143070010|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Other nervous system disorders||||0.4768
71785396|NCT03975790|143070010|SUPERIORITY|||||||0.0219|||||||Chi-squared|||Other skin disorders||||0.0219
71785397|NCT03975790|143070010|SUPERIORITY|||||||0.5172|||||||Chi-squared|||Other skin disorders||||0.5172
71785398|NCT03975790|143070010|SUPERIORITY|||||||0.0278|||||||Chi-squared|||Other skin disorders||||0.0278
71785399|NCT03975790|143070010|SUPERIORITY|||||||0.6103|||||||Chi-squared|||Thyroid disorders||||0.6103
71785400|NCT03975790|143070010|SUPERIORITY|||||||0.1682|||||||Chi-squared|||Thyroid disorders||||0.1682
71785401|NCT03975790|143070010|SUPERIORITY|||||||0.3654|||||||Chi-squared|||Thyroid disorders||||0.3654
71785402|NCT03975790|143070010|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7637
71785403|NCT03975790|143070010|SUPERIORITY|||||||0.8693|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.8693
71785404|NCT03975790|143070010|SUPERIORITY|||||||0.7349|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.7349
71785405|NCT03975790|143070010|SUPERIORITY|||||||0.7324|||||||Chi-squared|||Malaise/fatigue||||0.7324
71785406|NCT03975790|143070010|SUPERIORITY|||||||0.4182|||||||Chi-squared|||Malaise/fatigue||||0.4182
71785407|NCT03975790|143070010|SUPERIORITY|||||||0.62|||||||Chi-squared|||Malaise/fatigue||||0.6200
71785408|NCT03975790|143070010|SUPERIORITY|||||||0.6064|||||||Chi-squared|||Esophageal disorders||||0.6064
71785409|NCT03975790|143070010|SUPERIORITY|||||||0.636|||||||Chi-squared|||Esophageal disorders||||0.6360
71785410|NCT03975790|143070010|SUPERIORITY|||||||0.9445|||||||Chi-squared|||Esophageal disorders||||0.9445
71785411|NCT03975790|143070010|SUPERIORITY|||||||0.8135|||||||Chi-squared|||Nutritional deficiencies||||0.8135
71785412|NCT03975790|143070010|SUPERIORITY|||||||0.6705|||||||Chi-squared|||Nutritional deficiencies||||0.6705
71785413|NCT03975790|143070010|SUPERIORITY|||||||0.8331|||||||Chi-squared|||Nutritional deficiencies||||0.8331
71785414|NCT03975790|143070010|SUPERIORITY|||||||0.4158|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.4158
71785415|NCT03975790|143070010|SUPERIORITY|||||||0.636|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.6360
71785416|NCT03975790|143070010|SUPERIORITY|||||||0.3336|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders||||0.3336
71785417|NCT03975790|143070010|SUPERIORITY|||||||0.6402|||||||Chi-squared|||Diabetes mellitus without complication||||0.6402
71785418|NCT03975790|143070010|SUPERIORITY|||||||0.8068|||||||Chi-squared|||Diabetes mellitus without complication||||0.8068
71785419|NCT03975790|143070010|SUPERIORITY|||||||0.5983|||||||Chi-squared|||Diabetes mellitus without complication||||0.5983
71785420|NCT03975790|143070010|SUPERIORITY|||||||0.9759|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.9759
71785421|NCT03975790|143070010|SUPERIORITY|||||||0.136|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1360
71785422|NCT03975790|143070010|SUPERIORITY|||||||0.1815|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.1815
71785423|NCT03975790|143070010|SUPERIORITY|||||||0.2731|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.2731
71785424|NCT03975790|143070010|SUPERIORITY|||||||0.8327|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.8327
71836429|NCT05374837|143178597|SUPERIORITY||Odds Ratio (OR)|0.9669||||0.145|TWO_SIDED|95.0|0.43|2.1742||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic||Odds of consuming a minimum acceptable diet in intervention group at endline.|||2.1742|0.43|0.145
71669513|NCT00116779|142856373|SUPERIORITY_OR_OTHER||Percentage of participants|86.0||||||95.0|73.0|94.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||94|73|
71669514|NCT00116779|142856373|SUPERIORITY_OR_OTHER||Percentage of participants|77.0||||||95.0|64.0|88.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||88|64|
71669515|NCT00116779|142856374|SUPERIORITY_OR_OTHER||Percentage of participants|90.0||||||95.0|79.0|96.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||96|79|
71836430|NCT05374837|143178598|SUPERIORITY||Odds Ratio (OR)|0.3084||||0.179|TWO_SIDED|95.0|0.1977|0.481||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.481|0.1977|0.179
71836431|NCT05374837|143178598|SUPERIORITY||Odds Ratio (OR)|0.438||||0.179|TWO_SIDED|95.0|0.2983|0.6431||The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.|Regression, Logistic|||||0.6431|0.2983|0.179
71836432|NCT05374837|143178604|SUPERIORITY|||||||0.054||||||A priori threshold for statistical significance \<0.05.|Chi-squared|||||||0.054
71836433|NCT05374837|143178605|SUPERIORITY|||||||0.65||||||A priori threshold for statistical significance \<0.05|Chi-squared|||||||0.65
71836434|NCT03149315|143178611|SUPERIORITY|Values for grouped data were reported as mean ± SD and were calculated using Graphpad Prism 7 software (La Jolla, CA), which was also used for generating figures and for statistical analyses. Changes in skin test area (wheal and flare) were analyzed at each time point (after 2 doses, 4 doses, etc) using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.|||||<|0.0001||||||The above p value reflects the statistical analysis of skin test area between baseline and 2 doses of ibrutinib.|Wilcoxon (Mann-Whitney)|Changes in skin test area at each time point were analyzed using Friedman tests for grouped analysis and Wilcoxon signed rank tests between pairs.||||||<0.0001
71669516|NCT00116779|142856374|SUPERIORITY_OR_OTHER||Percentage of participants|89.0||||||95.0|78.0|95.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||95|78|
71669517|NCT00116779|142856374|SUPERIORITY_OR_OTHER|||||||0.8413||95.0|||||Chi-squared|||||||0.8413
71669518|NCT00116779|142856375|SUPERIORITY_OR_OTHER||Percentage of participants|93.0||||||95.0|82.0|99.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||99|82|
71669519|NCT00116779|142856375|SUPERIORITY_OR_OTHER||Percentage of participants|98.0||||||95.0|87.0|100.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.|||100|87|
71836435|NCT03149315|143178612|SUPERIORITY|Changes in BAT were analyzed at each time point (after 2 doses, 4 doses, etc) using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs. A p value \< 0.05 was considered significant.|||||<|0.001||||||The above p value reflects the statistical analysis of BAT between baseline and 2 doses of ibrutinib.|ANOVA|Changes in BAT were analyzed at each time point using repeated measures ANOVA for grouped analysis and paired Students t tests between pairs.||||||<0.001
71836436|NCT05406921|143178615|SUPERIORITY||Mean Difference (Net)|0.32|||<|0.05|TWO_SIDED||||||ANOVA|||This was a feasibility study and not powered to detect significant differences pre-/post-intervention.||||<0.05
71836437|NCT04299009|143178617|OTHER|multilevel linear models with Epworth sleepiness score scores as the dependent variable; treatment block (BLT vs sBLT) as a fixed effect; treatment sequence as a covariate; and participant intercept as a random effect.|regression coefficient|2.45|||<|0.05|TWO_SIDED|95.0|-0.3|5.19|||Mixed Models Analysis|||||5.19|-0.30|<0.05
71836438|NCT05059262|143178625|SUPERIORITY||Difference in ORR|39.0|||<|0.0001|TWO_SIDED|95.0|28.4|49.6||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on Interactive Response Technology (IRT).|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT|||49.6|28.4|<0.0001
71836439|NCT05059262|143178626|SUPERIORITY||Difference in ORR|67.2|||<|0.0001|TWO_SIDED|95.0|57.0|77.3||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||77.3|57.0|<0.0001
71669520|NCT00116779|142856376|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Log Rank|||Time to 50% reduction||||.904
71669521|NCT00116779|142856376|SUPERIORITY_OR_OTHER|||||||0.778||95.0|||||Log Rank|||Days to 90% reduction||||.778
71669522|NCT02105467|142856386|SUPERIORITY_OR_OTHER||||||<|0.001|||||||One-sided, one-sample exact test|||Superiority of SVR12 in the Immediate Treatment group was tested against the historical response rate of 73%.||||<0.001
71669523|NCT02105467|142856387|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-10.8|9.6|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||9.6|-10.8|
71669524|NCT02105467|142856388|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-4.4|2.0|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.|||2.0|-4.4|
71669525|NCT01037218|142856391|SUPERIORITY_OR_OTHER||Difference in LS Means|3.38|||<|0.0001|TWO_SIDED|95.0|1.7|5.07|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||5.07|1.70|<0.0001
71669526|NCT01037218|142856391|SUPERIORITY_OR_OTHER||Difference in LS Means|5.74|||<|0.0001|TWO_SIDED|95.0|4.05|7.43|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||7.43|4.05|<0.0001
71891877|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
71669527|NCT01037218|142856391|SUPERIORITY_OR_OTHER||Difference in LS Means|7.53|||<|0.0001|TWO_SIDED|95.0|5.86|9.2|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||9.20|5.86|<0.0001
71785425|NCT03975790|143070010|SUPERIORITY|||||||0.342|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions||||0.3420
71785426|NCT03975790|143070011|SUPERIORITY|||||||0.059|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.0590
71785427|NCT03975790|143070011|SUPERIORITY|||||||0.7055|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.7055
71785428|NCT03975790|143070011|SUPERIORITY|||||||0.3088|||||||Chi-squared|||Rheumatoid arthritis/related disease||||0.3088
71785429|NCT03975790|143070011|SUPERIORITY|||||||0.0036|||||||Chi-squared|||Other aftercare||||0.0036
71785430|NCT03975790|143070011|SUPERIORITY|||||||0.3772|||||||Chi-squared|||Other aftercare||||0.3772
71785431|NCT03975790|143070011|SUPERIORITY|||||||0.3|||||||Chi-squared|||Other aftercare||||0.3000
71785432|NCT03975790|143070011|SUPERIORITY|||||||0.7354|||||||Chi-squared|||Other connective tissue disease||||0.7354
71785433|NCT03975790|143070011|SUPERIORITY|||||||0.1435|||||||Chi-squared|||Other connective tissue disease||||0.1435
71785434|NCT03975790|143070011|SUPERIORITY|||||||0.2876|||||||Chi-squared|||Other connective tissue disease||||0.2876
71785435|NCT03975790|143070011|SUPERIORITY|||||||0.2848|||||||Chi-squared|||Other non-traumatic joint disorders||||0.2848
71785436|NCT03975790|143070011|SUPERIORITY|||||||0.183|||||||Chi-squared|||Other non-traumatic joint disorders||||0.1830
71785437|NCT03975790|143070011|SUPERIORITY|||||||0.6453|||||||Chi-squared|||Other non-traumatic joint disorders||||0.6453
71785438|NCT03975790|143070011|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
71785439|NCT03975790|143070011|SUPERIORITY|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation||||0.8717
71785440|NCT03975790|143070011|SUPERIORITY|||||||0.3422|||||||Chi-squared|||Medical examination/evaluation||||0.3422
71785441|NCT03975790|143070011|SUPERIORITY|||||||0.3465|||||||Chi-squared|||Other suspected conditions||||0.3465
71785442|NCT03975790|143070011|SUPERIORITY|||||||0.4953|||||||Chi-squared|||Other suspected conditions||||0.4953
71785443|NCT03975790|143070011|SUPERIORITY|||||||0.9796|||||||Chi-squared|||Other suspected conditions||||0.9796
71785444|NCT03975790|143070011|SUPERIORITY|||||||0.4187|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.4187
71785445|NCT03975790|143070011|SUPERIORITY|||||||0.151|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.1510
71785446|NCT03975790|143070011|SUPERIORITY|||||||0.0751|||||||Chi-squared|||Immunizations/screening for infectious disease||||0.0751
71785447|NCT03975790|143070011|SUPERIORITY|||||||0.7577|||||||Chi-squared|||Osteoarthritis||||0.7577
71785448|NCT03975790|143070011|SUPERIORITY|||||||0.802|||||||Chi-squared|||Osteoarthritis||||0.8020
71785449|NCT03975790|143070011|SUPERIORITY|||||||0.9879|||||||Chi-squared|||Osteoarthritis||||0.9879
71785450|NCT03975790|143070011|SUPERIORITY|||||||0.1717|||||||Chi-squared|||Essential hypertension||||0.1717
71785451|NCT03975790|143070011|SUPERIORITY|||||||0.3065|||||||Chi-squared|||Essential hypertension||||0.3065
71785452|NCT03975790|143070011|SUPERIORITY|||||||0.992|||||||Chi-squared|||Essential hypertension||||0.9920
71785453|NCT03975790|143070011|SUPERIORITY|||||||0.4626|||||||Chi-squared|||Residual codes; unclassified||||0.4626
71785454|NCT03975790|143070011|SUPERIORITY|||||||0.8922|||||||Chi-squared|||Residual codes; unclassified||||0.8922
71785455|NCT03975790|143070011|SUPERIORITY|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified||||0.7143
71785456|NCT03975790|143070011|SUPERIORITY|||||||0.8212|||||||Chi-squared|||Disorders of lipid metabolism||||0.8212
71785457|NCT03975790|143070011|SUPERIORITY|||||||0.5732|||||||Chi-squared|||Disorders of lipid metabolism||||0.5732
71785458|NCT03975790|143070011|SUPERIORITY|||||||0.7319|||||||Chi-squared|||Disorders of lipid metabolism||||0.7319
71785459|NCT03975790|143070011|SUPERIORITY|||||||0.9272|||||||Chi-squared|||Back problems||||0.9272
71785460|NCT03975790|143070011|SUPERIORITY|||||||0.1441|||||||Chi-squared|||Back problems||||0.1441
71785461|NCT03975790|143070011|SUPERIORITY|||||||0.1859|||||||Chi-squared|||Back problems||||0.1859
71785462|NCT03975790|143070011|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Other upper respiratory infections||||0.3109
71785463|NCT03975790|143070011|SUPERIORITY|||||||0.3313|||||||Chi-squared|||Other upper respiratory infections||||0.3313
71785464|NCT03975790|143070011|SUPERIORITY|||||||0.1279|||||||Chi-squared|||Other upper respiratory infections||||0.1279
71785465|NCT03975790|143070011|SUPERIORITY|||||||0.7575|||||||Chi-squared|||Other lower respiratory disease||||0.7575
71785466|NCT03975790|143070011|SUPERIORITY|||||||0.1583|||||||Chi-squared|||Other lower respiratory disease||||0.1583
71785467|NCT03975790|143070011|SUPERIORITY|||||||0.1569|||||||Chi-squared|||Other lower respiratory disease||||0.1569
71785468|NCT03975790|143070011|SUPERIORITY|||||||0.0745|||||||Chi-squared|||Other nervous system disorders||||0.0745
71785469|NCT03975790|143070011|SUPERIORITY|||||||0.0933|||||||Chi-squared|||Other nervous system disorders||||0.0933
71785470|NCT03975790|143070011|SUPERIORITY|||||||0.791|||||||Chi-squared|||Other nervous system disorders||||0.7910
71785471|NCT03975790|143070011|SUPERIORITY|||||||0.6755|||||||Chi-squared|||Other skin disorders||||0.6755
71785472|NCT03975790|143070011|SUPERIORITY|||||||0.4183|||||||Chi-squared|||Other skin disorders||||0.4183
71785473|NCT03975790|143070011|SUPERIORITY|||||||0.6749|||||||Chi-squared|||Other skin disorders||||0.6749
71836440|NCT05059262|143178627|SUPERIORITY||LS Mean Difference|14.6||||0.0077|TWO_SIDED|95.0|4.0|25.3||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.)+joint type (knee, ankle, or other)+the most impaired ROM baseline value.|Mixed model repeated measures|||||25.3|4.0|0.0077
71785474|NCT03975790|143070011|SUPERIORITY|||||||0.6626|||||||Chi-squared|||Thyroid disorders||||0.6626
71785475|NCT03975790|143070011|SUPERIORITY|||||||0.5766|||||||Chi-squared|||Thyroid disorders||||0.5766
71785476|NCT03975790|143070011|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Thyroid disorders||||0.8376
71785477|NCT03975790|143070011|SUPERIORITY|||||||0.2857|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.2857
71785478|NCT03975790|143070011|SUPERIORITY|||||||0.956|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.9560
71785479|NCT03975790|143070011|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Other bone disease/musculoskeletal deformities||||0.4384
71785480|NCT03975790|143070011|SUPERIORITY|||||||0.6082|||||||Chi-squared|||Malaise/fatigue||||0.6082
71785481|NCT03975790|143070011|SUPERIORITY|||||||0.3374|||||||Chi-squared|||Malaise/fatigue||||0.3374
71785482|NCT03975790|143070011|SUPERIORITY|||||||0.5984|||||||Chi-squared|||Malaise/fatigue||||0.5984
71785483|NCT03975790|143070011|SUPERIORITY|||||||0.8568|||||||Chi-squared|||Esophageal disorders||||0.8568
71785484|NCT03975790|143070011|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Esophageal disorders||||0.7698
71785485|NCT03975790|143070011|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Esophageal disorders||||0.7089
71785486|NCT03975790|143070011|SUPERIORITY|||||||0.3446|||||||Chi-squared|||Nutritional deficiencies||||0.3446
71785487|NCT03975790|143070011|SUPERIORITY|||||||0.0815|||||||Chi-squared|||Nutritional deficiencies||||0.0815
71785488|NCT03975790|143070011|SUPERIORITY|||||||0.402|||||||Chi-squared|||Nutritional deficiencies||||0.4020
71785489|NCT03975790|143070011|SUPERIORITY|||||||0.4246|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.4246
71785490|NCT03975790|143070011|SUPERIORITY|||||||0.8118|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.8118
71785491|NCT03975790|143070011|SUPERIORITY|||||||0.7454|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders||||0.7454
71785492|NCT03975790|143070011|SUPERIORITY|||||||0.3559|||||||Chi-squared|||Diabetes mellitus without complication||||0.3559
71785493|NCT03975790|143070011|SUPERIORITY|||||||0.7698|||||||Chi-squared|||Diabetes mellitus without complication||||0.7698
71785494|NCT03975790|143070011|SUPERIORITY|||||||0.7323|||||||Chi-squared|||Diabetes mellitus without complication||||0.7323
71785495|NCT03975790|143070011|SUPERIORITY|||||||0.5935|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.5935
71785496|NCT03975790|143070011|SUPERIORITY|||||||0.3928|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.3928
71785497|NCT03975790|143070011|SUPERIORITY|||||||0.7089|||||||Chi-squared|||Other/unspecified benign neoplasm||||0.7089
71785498|NCT03975790|143070011|SUPERIORITY|||||||0.8746|||||||Chi-squared|||Other upper respiratory disease||||0.8746
71785499|NCT03975790|143070011|SUPERIORITY|||||||0.3835|||||||Chi-squared|||Other upper respiratory disease||||0.3835
71785500|NCT03975790|143070011|SUPERIORITY|||||||0.4992|||||||Chi-squared|||Other upper respiratory disease||||0.4992
71785501|NCT03975790|143070012|SUPERIORITY|||||||0.2336|||||||t-test|||||||0.2336
71785502|NCT03975790|143070012|SUPERIORITY|||||||0.2109|||||||t-test|||||||0.2109
71785503|NCT03975790|143070012|SUPERIORITY|||||||0.0691|||||||t-test|||||||0.0691
71785504|NCT03975790|143070013|SUPERIORITY|||||||0.9758|||||||Chi-squared|||MTX Sodium||||0.9758
71785505|NCT03975790|143070013|SUPERIORITY|||||||0.9978|||||||Chi-squared|||MTX Sodium||||0.9978
71785506|NCT03975790|143070013|SUPERIORITY|||||||0.9861|||||||Chi-squared|||MTX Sodium||||0.9861
71785507|NCT03975790|143070013|SUPERIORITY|||||||0.5744|||||||Chi-squared|||Folic Acid||||0.5744
71785508|NCT03975790|143070013|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Folic Acid||||0.8542
71785509|NCT03975790|143070013|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Folic Acid||||0.8363
71785510|NCT03975790|143070013|SUPERIORITY|||||||0.0473|||||||Chi-squared|||Prednisone||||0.0473
71785511|NCT03975790|143070013|SUPERIORITY|||||||0.0327|||||||Chi-squared|||Prednisone||||0.0327
71785512|NCT03975790|143070013|SUPERIORITY|||||||0.5348|||||||Chi-squared|||Prednisone||||0.5348
71785513|NCT03975790|143070013|SUPERIORITY|||||||0.6934|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6934
71785514|NCT03975790|143070013|SUPERIORITY|||||||0.6017|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.6017
71785515|NCT03975790|143070013|SUPERIORITY|||||||0.4768|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.4768
71785516|NCT03975790|143070013|SUPERIORITY|||||||0.2315|||||||Chi-squared|||Azithromycin||||0.2315
71785517|NCT03975790|143070013|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Azithromycin||||0.2588
71785518|NCT03975790|143070013|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Azithromycin||||0.8576
71785519|NCT03975790|143070013|SUPERIORITY|||||||0.5909|||||||Chi-squared|||Adalimumab||||0.5909
71785520|NCT03975790|143070013|SUPERIORITY|||||||0.057|||||||Chi-squared|||Adalimumab||||0.0570
71785521|NCT03975790|143070013|SUPERIORITY|||||||0.0408|||||||Chi-squared|||Adalimumab||||0.0408
71785522|NCT03975790|143070013|SUPERIORITY|||||||0.6465|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.6465
71785523|NCT03975790|143070013|SUPERIORITY|||||||0.5654|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.5654
71785524|NCT03975790|143070013|SUPERIORITY|||||||0.8371|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.8371
71785525|NCT03975790|143070013|SUPERIORITY|||||||0.9654|||||||Chi-squared|||Etanercept||||0.9654
71785526|NCT03975790|143070013|SUPERIORITY|||||||0.1013|||||||Chi-squared|||Etanercept||||0.1013
71785527|NCT03975790|143070013|SUPERIORITY|||||||0.158|||||||Chi-squared|||Etanercept||||0.1580
71785528|NCT03975790|143070013|SUPERIORITY|||||||0.1663|||||||Chi-squared|||Levothyroxine Sodium||||0.1663
71785529|NCT03975790|143070013|SUPERIORITY|||||||0.6563|||||||Chi-squared|||Levothyroxine Sodium||||0.6563
71669528|NCT01037218|142856392|SUPERIORITY_OR_OTHER||Difference in LS Means|20.19|||<|0.0001|TWO_SIDED|95.0|13.44|26.93|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.93|13.44|<0.0001
71753352|NCT03583099|143009436|SUPERIORITY||Difference in proportion|0.82||||0.94|TWO_SIDED|95.0|-20.92|21.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||21.92|-20.92|0.94
71785530|NCT03975790|143070013|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
71785531|NCT03975790|143070013|SUPERIORITY|||||||0.4166|||||||Chi-squared|||Methylprednisolone||||0.4166
71785532|NCT03975790|143070013|SUPERIORITY|||||||0.0636|||||||Chi-squared|||Methylprednisolone||||0.0636
71785533|NCT03975790|143070013|SUPERIORITY|||||||0.3137|||||||Chi-squared|||Methylprednisolone||||0.3137
71785534|NCT03975790|143070013|SUPERIORITY|||||||0.4568|||||||Chi-squared|||Omeprazole||||0.4568
71785535|NCT03975790|143070013|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Omeprazole||||0.5785
71785536|NCT03975790|143070013|SUPERIORITY|||||||0.9541|||||||Chi-squared|||Omeprazole||||0.9541
71785537|NCT03975790|143070013|SUPERIORITY|||||||0.1956|||||||Chi-squared|||Tramadol Hydrochloride||||0.1956
71785538|NCT03975790|143070013|SUPERIORITY|||||||0.3633|||||||Chi-squared|||Tramadol Hydrochloride||||0.3633
71785539|NCT03975790|143070013|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Tramadol Hydrochloride||||0.9481
71785540|NCT03975790|143070013|SUPERIORITY|||||||0.3653|||||||Chi-squared|||Meloxicam||||0.3653
71785541|NCT03975790|143070013|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Meloxicam||||0.9255
71785542|NCT03975790|143070013|SUPERIORITY|||||||0.5137|||||||Chi-squared|||Meloxicam||||0.5137
71785543|NCT03975790|143070013|SUPERIORITY|||||||0.6338|||||||Chi-squared|||Amoxicillin||||0.6338
71785544|NCT03975790|143070013|SUPERIORITY|||||||0.6329|||||||Chi-squared|||Amoxicillin||||0.6329
71785545|NCT03975790|143070013|SUPERIORITY|||||||0.9228|||||||Chi-squared|||Amoxicillin||||0.9228
71785546|NCT03975790|143070013|SUPERIORITY|||||||0.8433|||||||Chi-squared|||Albuterol Sulfate||||0.8433
71785547|NCT03975790|143070013|SUPERIORITY|||||||0.1175|||||||Chi-squared|||Albuterol Sulfate||||0.1175
71785548|NCT03975790|143070013|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Albuterol Sulfate||||0.1215
71785549|NCT03975790|143070013|SUPERIORITY|||||||0.9007|||||||Chi-squared|||Gabapentin||||0.9007
71785550|NCT03975790|143070013|SUPERIORITY|||||||0.8789|||||||Chi-squared|||Gabapentin||||0.8789
71785551|NCT03975790|143070013|SUPERIORITY|||||||0.8305|||||||Chi-squared|||Gabapentin||||0.8305
71785552|NCT03975790|143070013|SUPERIORITY|||||||0.0694|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.0694
71785553|NCT03975790|143070013|SUPERIORITY|||||||0.8606|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.8606
71785554|NCT03975790|143070013|SUPERIORITY|||||||0.3363|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.3363
71785555|NCT03975790|143070013|SUPERIORITY|||||||0.3319|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.3319
71785556|NCT03975790|143070013|SUPERIORITY|||||||0.5615|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.5615
71785557|NCT03975790|143070013|SUPERIORITY|||||||0.8898|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8898
71785558|NCT03975790|143070013|SUPERIORITY|||||||0.367|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.3670
71785559|NCT03975790|143070013|SUPERIORITY|||||||0.8155|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.8155
71785560|NCT03975790|143070013|SUPERIORITY|||||||0.7091|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7091
71785561|NCT03975790|143070013|SUPERIORITY|||||||0.9769|||||||Chi-squared|||Fluticasone Propionate||||0.9769
71785562|NCT03975790|143070013|SUPERIORITY|||||||0.5032|||||||Chi-squared|||Fluticasone Propionate||||0.5032
71785563|NCT03975790|143070013|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Fluticasone Propionate||||0.5631
71785564|NCT03975790|143070013|SUPERIORITY|||||||0.4426|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.4426
71785565|NCT03975790|143070013|SUPERIORITY|||||||0.5734|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5734
71785566|NCT03975790|143070013|SUPERIORITY|||||||0.3071|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.3071
71785567|NCT03975790|143070013|SUPERIORITY|||||||0.1608|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1608
71785568|NCT03975790|143070013|SUPERIORITY|||||||0.4092|||||||Chi-squared|||Duloxetine Hydrochloride||||0.4092
71785569|NCT03975790|143070013|SUPERIORITY|||||||0.1215|||||||Chi-squared|||Duloxetine Hydrochloride||||0.1215
71785570|NCT03975790|143070013|SUPERIORITY|||||||0.7279|||||||Chi-squared|||Atorvastatin Calcium||||0.7279
71785571|NCT03975790|143070013|SUPERIORITY|||||||0.7703|||||||Chi-squared|||Atorvastatin Calcium||||0.7703
71785572|NCT03975790|143070013|SUPERIORITY|||||||0.6254|||||||Chi-squared|||Atorvastatin Calcium||||0.6254
71785573|NCT03975790|143070013|SUPERIORITY|||||||0.1615|||||||Chi-squared|||Diclofenac Sodium||||0.1615
71785574|NCT03975790|143070013|SUPERIORITY|||||||0.505|||||||Chi-squared|||Diclofenac Sodium||||0.5050
71785575|NCT03975790|143070013|SUPERIORITY|||||||0.1592|||||||Chi-squared|||Diclofenac Sodium||||0.1592
71785576|NCT03975790|143070013|SUPERIORITY|||||||0.6088|||||||Chi-squared|||Levofloxacin||||0.6088
71785577|NCT03975790|143070013|SUPERIORITY|||||||0.4713|||||||Chi-squared|||Levofloxacin||||0.4713
71785578|NCT03975790|143070013|SUPERIORITY|||||||0.3399|||||||Chi-squared|||Levofloxacin||||0.3399
71785579|NCT03975790|143070014|SUPERIORITY|||||||0.2349|||||||Chi-squared|||MTX Sodium||||0.2349
71785580|NCT03975790|143070014|SUPERIORITY|||||||0.3956|||||||Chi-squared|||MTX Sodium||||0.3956
71785581|NCT03975790|143070014|SUPERIORITY|||||||0.55|||||||Chi-squared|||Folic Acid||||0.5500
71785582|NCT03975790|143070014|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Folic Acid||||0.7131
71785583|NCT03975790|143070014|SUPERIORITY|||||||0.942|||||||Chi-squared|||Folic Acid||||0.9420
71785584|NCT03975790|143070014|SUPERIORITY|||||||0.0571|||||||Chi-squared|||Prednisone||||0.0571
71785585|NCT03975790|143070014|SUPERIORITY|||||||0.049|||||||Chi-squared|||Prednisone||||0.0490
71836441|NCT05059262|143178628|SUPERIORITY||LS Mean Difference|3.3||||0.0007|TWO_SIDED|95.0|1.4|5.2||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+PROMIS-PF baseline value.|Mixed model repeated measures|||||5.2|1.4|0.0007
71753353|NCT03583099|143009437|SUPERIORITY||Difference in proportion|-3.4||||0.55|TWO_SIDED|95.0|-14.4|7.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.6|-14.4|0.55
71753354|NCT03583099|143009439|SUPERIORITY||Difference in proportion|-1.1||||0.8|TWO_SIDED|95.0|-9.3|7.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.1|-9.3|0.80
71753355|NCT03583099|143009441|SUPERIORITY||Difference in proportion|-3.9||||0.18|TWO_SIDED|95.0|-9.7|1.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.8|-9.7|0.18
71785586|NCT03975790|143070014|SUPERIORITY|||||||0.5631|||||||Chi-squared|||Prednisone||||0.5631
71785587|NCT03975790|143070014|SUPERIORITY|||||||0.2198|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.2198
71753356|NCT03583099|143009442|SUPERIORITY||Difference in proportion|-0.17||||0.99|TWO_SIDED|95.0|-26.06|25.72|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||25.72|-26.06|0.99
71753357|NCT03583099|143009443|SUPERIORITY||Difference in proportion|-2.6||||0.59|TWO_SIDED|95.0|-12.0|6.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.8|-12.0|0.59
71753358|NCT03583099|143009445|SUPERIORITY||Difference in proportion|1.9||||0.82|TWO_SIDED|95.0|-14.5|18.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||18.4|-14.5|0.82
71753359|NCT03583099|143009447|SUPERIORITY||Difference in proportion|7.6||||0.2|TWO_SIDED|95.0|-4.1|19.3|||Wilcoxon (Mann-Whitney)||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.3|-4.1|0.20
71753360|NCT03583099|143009449|SUPERIORITY||Difference in proportion|4.9||||0.36|TWO_SIDED|95.0|-5.5|15.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||15.3|-5.5|0.36
71753361|NCT03583099|143009451|SUPERIORITY||Difference in proportion|4.6||||0.47|TWO_SIDED|95.0|-7.9|17.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||17.1|-7.9|0.47
71753362|NCT03583099|143009453|SUPERIORITY||Difference in proportion|0.6||||0.88|TWO_SIDED|95.0|-7.8|9.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.0|-7.8|0.88
71753363|NCT03583099|143009455|SUPERIORITY||Difference in proportion|-4.3||||0.27|TWO_SIDED|95.0|-12.0|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-12.0|0.27
71753364|NCT03583099|143009456|SUPERIORITY||Difference in proportion|-4.94||||0.82|TWO_SIDED|95.0|-47.92|38.04|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||38.04|-47.92|0.82
71753365|NCT03583099|143009457|SUPERIORITY||Difference in proportion|-1.1||||0.87|TWO_SIDED|95.0|-14.5|12.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||12.2|-14.5|0.87
71753366|NCT03583099|143009458|SUPERIORITY||Difference in proportion|-37.6||||0.03|TWO_SIDED|95.0|-71.8|-3.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-3.5|-71.8|0.03
71753367|NCT03583099|143009459|SUPERIORITY||Difference in proportion|2.3||||0.56|TWO_SIDED|95.0|-5.6|10.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.3|-5.6|0.56
71753368|NCT03583099|143009460|SUPERIORITY||Difference in proportion|-23.07||||0.06|TWO_SIDED|95.0|-47.4|1.27|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||1.27|-47.40|0.06
71753369|NCT03583099|143009461|SUPERIORITY||Difference in proportion|3.2||||0.39|TWO_SIDED|95.0|-4.0|10.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||10.4|-4.0|0.39
71785588|NCT03975790|143070014|SUPERIORITY|||||||0.385|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.3850
71785589|NCT03975790|143070014|SUPERIORITY|||||||0.1165|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate||||0.1165
71785590|NCT03975790|143070014|SUPERIORITY|||||||0.4291|||||||Chi-squared|||Azithromycin||||0.4291
71785591|NCT03975790|143070014|SUPERIORITY|||||||0.385|||||||Chi-squared|||Azithromycin||||0.3850
71785592|NCT03975790|143070014|SUPERIORITY|||||||0.8143|||||||Chi-squared|||Azithromycin||||0.8143
71785593|NCT03975790|143070014|SUPERIORITY|||||||0.7272|||||||Chi-squared|||Adalimumab||||0.7272
71785594|NCT03975790|143070014|SUPERIORITY|||||||0.0501|||||||Chi-squared|||Adalimumab||||0.0501
71785595|NCT03975790|143070014|SUPERIORITY|||||||0.05|||||||Chi-squared|||Adalimumab||||0.0500
71785596|NCT03975790|143070014|SUPERIORITY|||||||0.3116|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.3116
71785597|NCT03975790|143070014|SUPERIORITY|||||||0.4882|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.4882
71785598|NCT03975790|143070014|SUPERIORITY|||||||0.9505|||||||Chi-squared|||Hydroxychloroquine Sulfate||||0.9505
71836442|NCT05059262|143178629|SUPERIORITY||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+Worst Stiffness NRS baseline value.|Mixed model repeated measures|||||-1.1|-2.5|<0.0001
71785599|NCT03975790|143070014|SUPERIORITY|||||||0.408|||||||Chi-squared|||Etanercept||||0.4080
71785600|NCT03975790|143070014|SUPERIORITY|||||||0.7644|||||||Chi-squared|||Etanercept||||0.7644
71785601|NCT03975790|143070014|SUPERIORITY|||||||0.4146|||||||Chi-squared|||Etanercept||||0.4146
71785602|NCT03975790|143070014|SUPERIORITY|||||||0.1348|||||||Chi-squared|||Levothyroxine Sodium||||0.1348
71785603|NCT03975790|143070014|SUPERIORITY|||||||0.5948|||||||Chi-squared|||Levothyroxine Sodium||||0.5948
71785604|NCT03975790|143070014|SUPERIORITY|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium||||0.5785
71785605|NCT03975790|143070014|SUPERIORITY|||||||0.1033|||||||Chi-squared|||Methylprednisolone||||0.1033
71785606|NCT03975790|143070014|SUPERIORITY|||||||0.2117|||||||Chi-squared|||Methylprednisolone||||0.2117
71785607|NCT03975790|143070014|SUPERIORITY|||||||0.992|||||||Chi-squared|||Methylprednisolone||||0.9920
71785608|NCT03975790|143070014|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
71785609|NCT03975790|143070014|SUPERIORITY|||||||0.9212|||||||Chi-squared|||Omeprazole||||0.9212
71785610|NCT03975790|143070014|SUPERIORITY|||||||0.4384|||||||Chi-squared|||Omeprazole||||0.4384
71785611|NCT03975790|143070014|SUPERIORITY|||||||0.0162|||||||Chi-squared|||Tramadol Hydrochloride||||0.0162
71785612|NCT03975790|143070014|SUPERIORITY|||||||0.3239|||||||Chi-squared|||Tramadol Hydrochloride||||0.3239
71785613|NCT03975790|143070014|SUPERIORITY|||||||0.4837|||||||Chi-squared|||Tramadol Hydrochloride||||0.4837
71785614|NCT03975790|143070014|SUPERIORITY|||||||0.7183|||||||Chi-squared|||Meloxicam||||0.7183
71785615|NCT03975790|143070014|SUPERIORITY|||||||0.2667|||||||Chi-squared|||Meloxicam||||0.2667
71785616|NCT03975790|143070014|SUPERIORITY|||||||0.451|||||||Chi-squared|||Meloxicam||||0.4510
71785617|NCT03975790|143070014|SUPERIORITY|||||||0.7993|||||||Chi-squared|||Amoxicillin||||0.7993
71785618|NCT03975790|143070014|SUPERIORITY|||||||0.9896|||||||Chi-squared|||Amoxicillin||||0.9896
71785619|NCT03975790|143070014|SUPERIORITY|||||||0.8576|||||||Chi-squared|||Amoxicillin||||0.8576
71785620|NCT03975790|143070014|SUPERIORITY|||||||0.9373|||||||Chi-squared|||Albuterol Sulfate||||0.9373
71785621|NCT03975790|143070014|SUPERIORITY|||||||0.1253|||||||Chi-squared|||Albuterol Sulfate||||0.1253
71785622|NCT03975790|143070014|SUPERIORITY|||||||0.1851|||||||Chi-squared|||Albuterol Sulfate||||0.1851
71785623|NCT03975790|143070014|SUPERIORITY|||||||0.8697|||||||Chi-squared|||Gabapentin||||0.8697
71785624|NCT03975790|143070014|SUPERIORITY|||||||0.9719|||||||Chi-squared|||Gabapentin||||0.9719
71785625|NCT03975790|143070014|SUPERIORITY|||||||0.938|||||||Chi-squared|||Gabapentin||||0.9380
71785626|NCT03975790|143070014|SUPERIORITY|||||||0.1079|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.1079
71785627|NCT03975790|143070014|SUPERIORITY|||||||0.2588|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.2588
71785628|NCT03975790|143070014|SUPERIORITY|||||||0.9358|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride||||0.9358
71785629|NCT03975790|143070014|SUPERIORITY|||||||0.1984|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.1984
71785630|NCT03975790|143070014|SUPERIORITY|||||||0.8542|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.8542
71785631|NCT03975790|143070014|SUPERIORITY|||||||0.2973|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium||||0.2973
71785632|NCT03975790|143070014|SUPERIORITY|||||||0.1046|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.1046
71785633|NCT03975790|143070014|SUPERIORITY|||||||0.7961|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.7961
71785634|NCT03975790|143070014|SUPERIORITY|||||||0.214|||||||Chi-squared|||Cyclobenzaprine Hydrochloride||||0.2140
71785635|NCT03975790|143070014|SUPERIORITY|||||||0.8578|||||||Chi-squared|||Fluticasone Propionate||||0.8578
71785636|NCT03975790|143070014|SUPERIORITY|||||||0.7131|||||||Chi-squared|||Fluticasone Propionate||||0.7131
71785637|NCT03975790|143070014|SUPERIORITY|||||||0.8421|||||||Chi-squared|||Fluticasone Propionate||||0.8421
71785638|NCT03975790|143070014|SUPERIORITY|||||||0.7637|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.7637
71785639|NCT03975790|143070014|SUPERIORITY|||||||0.6355|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.6355
71785640|NCT03975790|143070014|SUPERIORITY|||||||0.5425|||||||Chi-squared|||Ciprofloxacin Hydrochloride||||0.5425
71785641|NCT03975790|143070014|SUPERIORITY|||||||0.041|||||||Chi-squared|||Duloxetine Hydrochloride||||0.0410
71785642|NCT03975790|143070014|SUPERIORITY|||||||0.8251|||||||Chi-squared|||Duloxetine Hydrochloride||||0.8251
71785643|NCT03975790|143070014|SUPERIORITY|||||||0.2871|||||||Chi-squared|||Duloxetine Hydrochloride||||0.2871
71785644|NCT03975790|143070014|SUPERIORITY|||||||0.1174|||||||Chi-squared|||Diclofenac Sodium||||0.1174
71785645|NCT03975790|143070014|SUPERIORITY|||||||0.9702|||||||Chi-squared|||Diclofenac Sodium||||0.9702
71785646|NCT03975790|143070014|SUPERIORITY|||||||0.3109|||||||Chi-squared|||Diclofenac Sodium||||0.3109
71669529|NCT01037218|142856392|SUPERIORITY_OR_OTHER||Difference in LS Means|25.06|||<|0.0001|TWO_SIDED|95.0|18.32|31.81|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||31.81|18.32|<0.0001
71669530|NCT01037218|142856392|SUPERIORITY_OR_OTHER||Difference in LS Means|32.84|||<|0.0001|TWO_SIDED|95.0|26.18|39.5|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||39.50|26.18|<0.0001
71669531|NCT01037218|142856393|SUPERIORITY_OR_OTHER||Difference in LS Means|21.72|||<|0.0001|TWO_SIDED|95.0|14.19|29.24|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||29.24|14.19|<0.0001
71891878|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.4|-0.3|
71891879|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
71669532|NCT01037218|142856393|SUPERIORITY_OR_OTHER||Difference in LS Means|26.82|||<|0.0001|TWO_SIDED|95.0|19.27|34.37|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||34.37|19.27|<0.0001
71785647|NCT03975790|143070014|SUPERIORITY|||||||0.6744|||||||Chi-squared|||Levofloxacin||||0.6744
71785648|NCT03975790|143070014|SUPERIORITY|||||||0.8121|||||||Chi-squared|||Levofloxacin||||0.8121
71785649|NCT03975790|143070014|SUPERIORITY|||||||0.9451|||||||Chi-squared|||Levofloxacin||||0.9451
71785650|NCT03975790|143070014|SUPERIORITY|||||||0.166|||||||Chi-squared|||Cephalexin||||0.1660
71785651|NCT03975790|143070014|SUPERIORITY|||||||0.9549|||||||Chi-squared|||Cephalexin||||0.9549
71785652|NCT03975790|143070014|SUPERIORITY|||||||0.3104|||||||Chi-squared|||Cephalexin||||0.3104
71785653|NCT03975790|143070014|SUPERIORITY|||||||0.0489|||||||Chi-squared|||Ibuprofen||||0.0489
71785654|NCT03975790|143070014|SUPERIORITY|||||||0.1515|||||||Chi-squared|||Ibuprofen||||0.1515
71785655|NCT03975790|143070014|SUPERIORITY|||||||0.9481|||||||Chi-squared|||Ibuprofen||||0.9481
71785656|NCT03975790|143070015|SUPERIORITY|||||||0.2178|||||||Chi-squared|||||||0.2178
71785657|NCT03975790|143070015|SUPERIORITY|||||||0.5237|||||||Chi-squared|||||||0.5237
71785658|NCT03975790|143070015|SUPERIORITY|||||||0.7964|||||||Chi-squared|||||||0.7964
71785659|NCT03975790|143070016|SUPERIORITY|||||||0.9085|||||||Chi-squared|||||||0.9085
71785660|NCT03975790|143070016|SUPERIORITY|||||||0.6283|||||||Chi-squared|||||||0.6283
71785661|NCT03975790|143070016|SUPERIORITY|||||||0.7293|||||||Chi-squared|||||||0.7293
71785662|NCT03975790|143070017|SUPERIORITY|||||||0.9392|||||||Chi-squared|||||||0.9392
71785663|NCT03975790|143070017|SUPERIORITY|||||||0.3063|||||||Chi-squared|||||||0.3063
71785664|NCT03975790|143070017|SUPERIORITY|||||||0.3467|||||||Chi-squared|||||||0.3467
71785665|NCT03975790|143070018|SUPERIORITY|||||||0.7977|||||||Chi-squared|||||||0.7977
71785666|NCT03975790|143070018|SUPERIORITY|||||||0.5241|||||||Chi-squared|||||||0.5241
71785667|NCT03975790|143070018|SUPERIORITY|||||||0.4702|||||||Chi-squared|||||||0.4702
71785668|NCT03975790|143070019|SUPERIORITY|||||||0.1461|||||||t-test|||||||0.1461
71785669|NCT03975790|143070019|SUPERIORITY|||||||0.1411|||||||t-test|||||||0.1411
71785670|NCT03975790|143070019|SUPERIORITY|||||||0.4201|||||||t-test|||||||0.4201
71785671|NCT03975790|143070020|SUPERIORITY|||||||0.3955|||||||t-test|||||||0.3955
71785672|NCT03975790|143070020|SUPERIORITY|||||||0.6356|||||||t-test|||||||0.6356
71785673|NCT03975790|143070020|SUPERIORITY|||||||0.3833|||||||t-test|||||||0.3833
71785674|NCT03975790|143070021|SUPERIORITY|||||||0.3292|||||||t-test|||||||0.3292
71785675|NCT03975790|143070021|SUPERIORITY|||||||0.2959|||||||t-test|||||||0.2959
71785676|NCT03975790|143070021|SUPERIORITY|||||||0.6962|||||||t-test|||||||0.6962
71785677|NCT03975790|143070022|SUPERIORITY|||||||0.8138|||||||t-test|||||||0.8138
71785678|NCT03975790|143070022|SUPERIORITY|||||||0.007|||||||t-test|||||||0.0070
71753370|NCT03583099|143009462|SUPERIORITY||Difference in proportion|-1.72||||0.84|TWO_SIDED|95.0|-18.24|14.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.80|-18.24|0.84
71753371|NCT03583099|143009463|SUPERIORITY||Difference in proportion|2.0||||0.42|TWO_SIDED|95.0|-2.9|6.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.9|-2.9|0.42
71753372|NCT03583099|143009464|SUPERIORITY||Difference in proportion|-42.09||||0.01|TWO_SIDED|95.0|-74.27|-9.92|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-9.92|-74.27|0.01
71753373|NCT03583099|143009465|SUPERIORITY||Difference in proportion|2.4||||0.47|TWO_SIDED|95.0|-4.2|9.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||9.1|-4.2|0.47
71753374|NCT03583099|143009466|SUPERIORITY||Difference in proportion|-12.27||||0.34|TWO_SIDED|95.0|-37.72|13.18|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.18|-37.72|0.34
71753375|NCT03583099|143009467|SUPERIORITY||Difference in proportion|2.4||||0.39|TWO_SIDED|95.0|-3.1|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-3.1|0.39
71753376|NCT03583099|143009469|SUPERIORITY||Difference in proportion|-1.2||||0.59|TWO_SIDED|95.0|-5.5|3.1|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.1|-5.5|0.59
71753377|NCT03583099|143009471|SUPERIORITY||Difference in proportion|0.3||||0.94|TWO_SIDED|95.0|-8.2|8.8|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.8|-8.2|0.94
71785679|NCT03975790|143070022|SUPERIORITY|||||||0.0358|||||||t-test|||||||0.0358
71785680|NCT03975790|143070023|SUPERIORITY|||||||0.8453|||||||t-test|||||||0.8453
71836443|NCT05059262|143178630|SUPERIORITY||LS Mean Difference|7.4||||0.0155|TWO_SIDED|95.0|1.4|13.4||Model included treatment+visit+treatment by visit interaction+stratification factor for region (U.S. versus non-U.S.) and tumor location (lower limb/all other) based on IRT+VAS baseline value.|Mixed model repeated measures|||||13.4|1.4|0.0155
71753378|NCT03583099|143009472|SUPERIORITY||Difference in proportion|0.6||||0.93|TWO_SIDED|95.0|-12.2|13.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||13.4|-12.2|0.93
71753379|NCT03583099|143009473|SUPERIORITY||Difference in proportion|-8.2||||0.25|TWO_SIDED|95.0|-22.0|5.7|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||5.7|-22.0|0.25
71753380|NCT03583099|143009474|SUPERIORITY||Difference in proportion|-3.4||||0.48|TWO_SIDED|95.0|-12.7|6.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||6.0|-12.7|0.48
71753381|NCT03583099|143009475|SUPERIORITY||Difference in proportion|3.9||||0.45|TWO_SIDED|95.0|-6.3|14.2|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||14.2|-6.3|0.45
71753382|NCT03583099|143009477|SUPERIORITY||Difference in proportion|-2.2||||0.48|TWO_SIDED|95.0|-8.4|3.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.9|-8.4|0.48
71753383|NCT03583099|143009478|SUPERIORITY||Difference in proportion|-0.4||||0.97|TWO_SIDED|95.0|-20.4|19.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||19.5|-20.4|0.97
71753384|NCT03583099|143009479|SUPERIORITY||Difference in proportion|-12.1||||0.04|TWO_SIDED|95.0|-23.5|-0.6|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||-0.6|-23.5|0.04
71753385|NCT03583099|143009480|SUPERIORITY||Difference in proportion|-1.8||||0.39|TWO_SIDED|95.0|-5.8|2.3|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.3|-5.8|0.39
71785681|NCT03975790|143070023|SUPERIORITY|||||||0.4806|||||||t-test|||||||0.4806
71785682|NCT03975790|143070023|SUPERIORITY|||||||0.4809|||||||t-test|||||||0.4809
71785683|NCT03975790|143070024|SUPERIORITY|||||||0.3076|||||||t-test|||||||0.3076
71785684|NCT03975790|143070024|SUPERIORITY|||||||0.2509|||||||t-test|||||||0.2509
71785685|NCT03975790|143070024|SUPERIORITY|||||||0.7827|||||||t-test|||||||0.7827
71785686|NCT03975790|143070025|SUPERIORITY|||||||0.4261|||||||Chi-squared|||During Persistency||||0.4261
71785687|NCT03975790|143070025|SUPERIORITY|||||||0.5247|||||||Chi-squared|||During Persistency||||0.5247
71785688|NCT03975790|143070025|SUPERIORITY|||||||0.2809|||||||Chi-squared|||During Persistency||||0.2809
71785689|NCT03975790|143070025|SUPERIORITY|||||||0.1153|||||||Chi-squared|||Post Persistency||||0.1153
71785690|NCT03975790|143070025|SUPERIORITY|||||||0.1344|||||||Chi-squared|||Post Persistency||||0.1344
71785691|NCT03975790|143070025|SUPERIORITY|||||||0.8229|||||||Chi-squared|||Post Persistency||||0.8229
71785692|NCT03975790|143070026|SUPERIORITY|||||||0.7816|||||||Chi-squared|||During Persistency||||0.7816
71753386|NCT03583099|143009481|SUPERIORITY||Difference in proportion|-7.3||||0.06|TWO_SIDED|95.0|-14.9|0.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||0.4|-14.9|0.06
71785693|NCT03975790|143070026|SUPERIORITY|||||||0.7124|||||||Chi-squared|||During Persistency||||0.7124
71785694|NCT03975790|143070026|SUPERIORITY|||||||0.6148|||||||Chi-squared|||During Persistency||||0.6148
71785695|NCT03975790|143070026|SUPERIORITY|||||||0.4876|||||||Chi-squared|||Post Persistency||||0.4876
71785696|NCT03975790|143070026|SUPERIORITY|||||||0.7826|||||||Chi-squared|||Post Persistency||||0.7826
71785697|NCT03975790|143070026|SUPERIORITY|||||||0.8337|||||||Chi-squared|||Post Persistency||||0.8337
71785698|NCT03975790|143070027|SUPERIORITY|||||||0.1344|||||||Chi-squared|||||||0.1344
71785699|NCT03975790|143070027|SUPERIORITY|||||||0.0095|||||||Chi-squared|||||||0.0095
71785700|NCT03975790|143070027|SUPERIORITY|||||||0.1406|||||||Chi-squared|||||||0.1406
71785701|NCT03975790|143070028|SUPERIORITY|||||||0.9379|||||||Chi-squared|||||||0.9379
71785702|NCT03975790|143070028|SUPERIORITY|||||||0.3025|||||||Chi-squared|||||||0.3025
71785703|NCT03975790|143070028|SUPERIORITY|||||||0.3388|||||||Chi-squared|||||||0.3388
71785704|NCT03975790|143070029|SUPERIORITY|||||||0.8205|||||||t-test|||||||0.8205
71785705|NCT03975790|143070029|SUPERIORITY|||||||0.0467|||||||t-test|||||||0.0467
71785706|NCT03975790|143070029|SUPERIORITY|||||||0.1083|||||||t-test|||||||0.1083
71785707|NCT03975790|143070030|SUPERIORITY|||||||0.8899|||||||t-test|||||||0.8899
71785708|NCT03975790|143070030|SUPERIORITY|||||||0.6183|||||||t-test|||||||0.6183
71785709|NCT03975790|143070030|SUPERIORITY|||||||0.6496|||||||t-test|||||||0.6496
71785710|NCT03975790|143070031|SUPERIORITY|||||||0.5027|||||||t-test|||||||0.5027
71785711|NCT03975790|143070031|SUPERIORITY|||||||0.2375|||||||t-test|||||||0.2375
71785712|NCT03975790|143070031|SUPERIORITY|||||||0.5577|||||||t-test|||||||0.5577
71785713|NCT03975790|143070032|SUPERIORITY|||||||0.6908|||||||t-test|||||||0.6908
71785714|NCT03975790|143070032|SUPERIORITY|||||||0.0859|||||||t-test|||||||0.0859
71785715|NCT03975790|143070032|SUPERIORITY|||||||0.2764|||||||t-test|||||||0.2764
71785716|NCT03975790|143070033|SUPERIORITY|||||||0.1906|||||||t-test|||||||0.1906
71785717|NCT03975790|143070033|SUPERIORITY|||||||0.8744|||||||t-test|||||||0.8744
71785718|NCT03975790|143070033|SUPERIORITY|||||||0.3295|||||||t-test|||||||0.3295
71785719|NCT03975790|143070034|SUPERIORITY|||||||0.0056|||||||t-test|||All cause||||0.0056
71785720|NCT03975790|143070034|SUPERIORITY|||||||0.4222|||||||t-test|||All cause||||0.4222
71785721|NCT03975790|143070034|SUPERIORITY|||||||0.0041|||||||t-test|||All cause||||0.0041
71785722|NCT03975790|143070034|SUPERIORITY|||||||0.2277|||||||t-test|||RA related||||0.2277
71785723|NCT03975790|143070034|SUPERIORITY|||||||0.2812|||||||t-test|||RA related||||0.2812
71785724|NCT03975790|143070034|SUPERIORITY|||||||0.0772|||||||t-test|||RA related||||0.0772
71785725|NCT03975790|143070035|SUPERIORITY|||||||0.293|||||||t-test|||All cause||||0.2930
71785726|NCT03975790|143070035|SUPERIORITY|||||||0.439|||||||t-test|||All cause||||0.4390
71785727|NCT03975790|143070035|SUPERIORITY|||||||0.153|||||||t-test|||All cause||||0.1530
71785728|NCT03975790|143070035|SUPERIORITY|||||||0.9439|||||||t-test|||RA related||||0.9439
71785729|NCT03975790|143070035|SUPERIORITY|||||||0.4477|||||||t-test|||RA related||||0.4477
71785730|NCT03975790|143070035|SUPERIORITY|||||||0.4519|||||||t-test|||RA related||||0.4519
71785731|NCT03975790|143070036|SUPERIORITY|||||||0.9829|||||||Chi-squared|||Cardiovascular Disease||||0.9829
71785732|NCT03975790|143070036|SUPERIORITY|||||||0.8021|||||||Chi-squared|||Cardiovascular Disease||||0.8021
71785733|NCT03975790|143070036|SUPERIORITY|||||||0.8376|||||||Chi-squared|||Cardiovascular Disease||||0.8376
71785734|NCT03975790|143070036|SUPERIORITY|||||||0.5927|||||||Chi-squared|||COPD||||0.5927
71785735|NCT03975790|143070036|SUPERIORITY|||||||0.5202|||||||Chi-squared|||COPD||||0.5202
71785736|NCT03975790|143070036|SUPERIORITY|||||||0.8517|||||||Chi-squared|||COPD||||0.8517
71785737|NCT03975790|143070036|SUPERIORITY|||||||8.33|||||||Chi-squared|||Asthma||||8.33
71785738|NCT03975790|143070036|SUPERIORITY|||||||0.7483|||||||Chi-squared|||Asthma||||0.7483
71785739|NCT03975790|143070036|SUPERIORITY|||||||0.9713|||||||Chi-squared|||Asthma||||0.9713
71785740|NCT03975790|143070036|SUPERIORITY|||||||0.9148|||||||Chi-squared|||Kidney disease||||0.9148
71785741|NCT03975790|143070036|SUPERIORITY|||||||0.7248|||||||Chi-squared|||Kidney disease||||0.7248
71785742|NCT03975790|143070036|SUPERIORITY|||||||0.82|||||||Chi-squared|||Kidney disease||||0.8200
71785743|NCT03975790|143070036|SUPERIORITY|||||||0.9657|||||||Chi-squared|||Diabetes||||0.9657
71785744|NCT03975790|143070036|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Diabetes||||0.9255
71785745|NCT03975790|143070036|SUPERIORITY|||||||0.9575|||||||Chi-squared|||Diabetes||||0.9575
71785746|NCT03975790|143070036|SUPERIORITY|||||||0.941|||||||Chi-squared|||Depression||||0.9410
71785747|NCT03975790|143070036|SUPERIORITY|||||||0.9146|||||||Chi-squared|||Depression||||0.9146
71785748|NCT03975790|143070036|SUPERIORITY|||||||0.9641|||||||Chi-squared|||Depression||||0.9641
71785749|NCT03975790|143070036|SUPERIORITY|||||||0.2596|||||||Chi-squared|||Anxiety||||0.2596
71785750|NCT03975790|143070036|SUPERIORITY|||||||0.2228|||||||Chi-squared|||Anxiety||||0.2228
71785751|NCT03975790|143070036|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Anxiety||||0.7824
71785752|NCT03975790|143070036|SUPERIORITY|||||||0.4184|||||||Chi-squared|||Liver disease||||0.4184
71785753|NCT03975790|143070036|SUPERIORITY|||||||0.4371|||||||Chi-squared|||Liver disease||||0.4371
71785754|NCT03975790|143070036|SUPERIORITY|||||||0.2074|||||||Chi-squared|||Liver disease||||0.2074
71785755|NCT03975790|143070036|SUPERIORITY|||||||0.785|||||||Chi-squared|||Sleep disorders||||0.7850
71785756|NCT03975790|143070036|SUPERIORITY|||||||0.1288|||||||Chi-squared|||Sleep disorders||||0.1288
71785757|NCT03975790|143070036|SUPERIORITY|||||||0.2839|||||||Chi-squared|||Sleep disorders||||0.2839
71785758|NCT03975790|143070037|SUPERIORITY|||||||0.2242|||||||Chi-squared|||||||0.2242
71785759|NCT03975790|143070037|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
71785760|NCT03975790|143070037|SUPERIORITY|||||||0.0557|||||||Chi-squared|||||||0.0557
71836444|NCT05059262|143178631|SUPERIORITY||Difference in responder rate|26.2||||0.0056|TWO_SIDED|95.0|9.5|42.8||Stratified by tumor location (lower limb/all other) and region (U.S./non-U.S.) based on IRT.|Cochran-Mantel-Haenszel||Stratified Mantel-Haenszel with stratification factors based on IRT.|||42.8|9.5|0.0056
71836445|NCT04501861|143178691|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure.|Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.043|0.022|||Mixed Models Analysis|||||0.022|-0.043|0.53
71836446|NCT04501861|143178691|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who with preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 52 and in vasopressin group is 40. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.022||||0.26|TWO_SIDED|95.0|-0.061|0.016|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.016|-0.061|0.26
71836447|NCT04501861|143178691|EQUIVALENCE|Compare mPAP-to-MAP ratio between patients who without preop PH received norepinephrine versus vasopressin intraoperatively. Post intervention measurements will be recorded after protamine administration until end of chest closure. The number of patients in norepinephrine group is 31 and in vasopressin group is 29. The significance level was 0.05 for all analyses. All tests were 2-sided. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-0.0035||||0.88|TWO_SIDED|95.0|-0.05|0.043|||Mixed Models Analysis|||mPAP-to-MAP ratio was compared between patients without pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension.||0.043|-0.05|0.88
71836448|NCT04501861|143178692|EQUIVALENCE|Imbalanced confounders such as female, coronary artery disease, preoperative ejection fraction, surgery type, primary or repeat surgery, and bypass time were additionally adjusted. A different inverse probability of treatment weighting was fit for secondary analysis and a linear mixed regression model with random intercept to account for intra-week correlation to estimate the effect of norepinephrine on right ventricular free wall strain using the new obtained stabilized weights|Mean Difference (Final Values)|-1.8||||0.37|TWO_SIDED|95.0|-6.0|2.3|||Mixed Models Analysis|||||2.3|-6.0|0.37
71836449|NCT04501861|143178692|EQUIVALENCE|We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by considering patients who have preoperative pulmonary hypertension. The number of patients in norepinephrine group is 34 and in vasopressin group is 28. The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-2.1||||0.39|TWO_SIDED|95.0|-7.1|2.8|||Mixed Models Analysis|||RV free wall strain compare between patients with pre-existing pulmonary hypertension of use of vasopressin and norepinephrine. Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension;||2.8|-7.1|0.39
71836450|NCT04501861|143178692|EQUIVALENCE|We're going to explore the interaction between preoperative pulmonary arterial hypertension status and treatment group by equivalence analysis. The number of patients in norepinephrine group is 22 and in vasopressin group is 18.The significance level was 0.05 for all analyses. All tests were 2-sided. The significance levels of subgroup analyses were not corrected for multiple comparisons. Interactions were considered significant when the interaction P was \< 0.10.|Mean Difference (Final Values)|-1.5||||0.63|TWO_SIDED|95.0|-7.6|4.6|||Mixed Models Analysis|||"We examined the effect of norepinephrine versus vasopressin on right ventricular free wall strain by separately considering patients who did not have preoperative pulmonary hypertension.~Preoperative pulmonary arterial hypertension was defined by using the cut-off value of 25 mmHg for the time-weighted average mPAP, i.e., time weighted average mPAP \< 25 mmHg indicated absence of preoperative pulmonary arterial hypertension; otherwise, presence of preoperative pulmonary hypertension."||4.6|-7.6|0.63
71836451|NCT05458011|143178741|OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.66|-0.95|||ANCOVA|||||-0.95|-2.66|<0.0001
71836452|NCT02724878|143178758|SUPERIORITY||Response Rate|33.0|||||TWO_SIDED|80.0|25.0|42.0||||||A sample size of 60 would provide 95% power to distinguish the ORR rate of 25% from 10% (historical control) with 1-sided alpha of 0.07. The treatment would be considered effective if 10 or more responses are observed out of 60 patients.||42|25|
71836453|NCT04838262|143178785|OTHER|||||||0.57|||||||Regression, Linear|||||||0.57
71669533|NCT01037218|142856393|SUPERIORITY_OR_OTHER||Difference in LS Means|35.41|||<|0.0001|TWO_SIDED|95.0|27.98|42.83|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||42.83|27.98|<0.0001
71836454|NCT04838262|143178785|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
71836455|NCT03175029|143178787|SUPERIORITY||Mean Difference (Final Values)|10.552|||<|0.001|TWO_SIDED|95.0|5.514|15.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the TAC-302 group||15.590|5.514|<0.001
71753387|NCT03583099|143009482|SUPERIORITY||Difference in proportion|-0.9||||0.82|TWO_SIDED|95.0|-8.8|7.0|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.0|-8.8|0.82
71785761|NCT03975790|143070038|SUPERIORITY|||||||0.5944|||||||Chi-squared|||Switch immediately||||0.5944
71785762|NCT03975790|143070038|SUPERIORITY|||||||0.9255|||||||Chi-squared|||Switch immediately||||0.9255
71785763|NCT03975790|143070038|SUPERIORITY|||||||0.7824|||||||Chi-squared|||Switch immediately||||0.7824
71785764|NCT03975790|143070038|SUPERIORITY|||||||0.3975|||||||Chi-squared|||Discontinue then switch||||0.3975
71753388|NCT03583099|143009483|SUPERIORITY||Difference in proportion|0.6||||0.86|TWO_SIDED|95.0|-6.6|7.9|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||7.9|-6.6|0.86
71753389|NCT03583099|143009484|SUPERIORITY||Difference in proportion|-7.4||||0.14|TWO_SIDED|95.0|-17.3|2.5|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||2.5|-17.3|0.14
71753390|NCT03583099|143009486|SUPERIORITY||Difference in proportion|-14.66||||0.21|TWO_SIDED|95.0|-37.54|8.22|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||8.22|-37.54|0.21
71753391|NCT03583099|143009487|SUPERIORITY||Difference in proportion|0.4||||0.76|TWO_SIDED|95.0|-2.0|2.7|||Generalized estimating equation contrast|||||2.7|-2.0|0.76
71753392|NCT03583099|143009490|SUPERIORITY||Difference in proportion|0.6||||0.66|TWO_SIDED|95.0|-2.1|3.4|||Generalized estimating equation contrast||The direction of the difference is Intervention: COPD education plus CAPTURE education and patient-level CAPTURE screening results minus the Enhanced Usual Care: COPD education.|||3.4|-2.1|0.66
71753393|NCT00807911|143009493|OTHER||Hazard Ratio (HR)|0.657||||0.047|TWO_SIDED|95.0|0.434|0.994|||t-test, 1 sided|||||0.994|0.434|0.047
71753394|NCT00807911|143009494|OTHER||Hazard Ratio (HR)|0.602||||0.04|TWO_SIDED|95.0|0.371|0.977|||t-test, 1 sided|||||0.977|0.371|0.040
71753395|NCT00807911|143009495|OTHER||Hazard Ratio (HR)|0.744||||0.47|TWO_SIDED|95.0|0.334|1.657|||t-test, 1 sided|||||1.657|0.334|0.47
71753396|NCT00807911|143009496|OTHER||Hazard Ratio (HR)|0.456||||0.036|TWO_SIDED|95.0|0.215|0.97|||t-test, 1 sided|||||0.970|0.215|0.036
71753397|NCT00836589|143009537|NON_INFERIORITY|"Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).~Type I error (alpha) is 0.05 (one-sided for non-inferiority).~Statistical power is 80%."||||||0.002|||||||Binomial Proportion|||||||0.0020
71753398|NCT01890343|143009553|SUPERIORITY_OR_OTHER|||||||0.002|||||||Kruskal-Wallis|||The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.||||0.002
71753399|NCT00772538|143009583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.034||0.011||95.0|0.02|0.152||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.152|0.020|0.0110
71753400|NCT00772538|143009584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.005||95.0|0.027|0.149||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.027|0.0050
71753401|NCT00772538|143009585|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
71753402|NCT00772538|143009586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.043||0.0362||95.0|0.006|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.006|0.0362
71753403|NCT00772538|143009587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.04||0.0007||95.0|0.058|0.214||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.214|0.058|0.0007
71753404|NCT00772538|143009588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.032||0.0067||95.0|0.024|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.024|0.0067
71753405|NCT00772538|143009589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.04||0.0139||95.0|0.02|0.176||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.176|0.020|0.0139
71753406|NCT00772538|143009590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.034||0.0347||95.0|0.005|0.14||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|0.005|0.0347
71753407|NCT00772538|143009591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.032||0.1896||95.0|-0.021|0.104||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.104|-0.021|0.1896
71669534|NCT01037218|142856394|SUPERIORITY_OR_OTHER||Difference in LS Means|1.52|||<|0.0001|TWO_SIDED|95.0|0.81|2.23|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.23|0.81|<0.0001
71669535|NCT01037218|142856394|SUPERIORITY_OR_OTHER||Difference in LS Means|2.29|||<|0.0001|TWO_SIDED|95.0|1.58|3.0|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.00|1.58|<0.0001
71669536|NCT01037218|142856394|SUPERIORITY_OR_OTHER||Difference in LS Means|2.9|||<|0.0001|TWO_SIDED|95.0|2.2|3.6|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||3.60|2.20|<0.0001
71669537|NCT01037218|142856395|SUPERIORITY_OR_OTHER||Difference in LS Means|0.59||||0.0673|TWO_SIDED|95.0|-0.04|1.22|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.22|-0.04|0.0673
71785765|NCT03975790|143070038|SUPERIORITY|||||||0.0552|||||||Chi-squared|||Discontinue then switch||||0.0552
71785766|NCT03975790|143070038|SUPERIORITY|||||||0.3914|||||||Chi-squared|||Discontinue then switch||||0.3914
71785767|NCT03975790|143070038|SUPERIORITY|||||||0.2036|||||||Chi-squared|||Discontinue then restart||||0.2036
71785768|NCT03975790|143070038|SUPERIORITY|||||||0.1336|||||||Chi-squared|||Discontinue then restart||||0.1336
71785769|NCT03975790|143070038|SUPERIORITY|||||||0.7095|||||||Chi-squared|||Discontinue then restart||||0.7095
71785770|NCT03975790|143070038|SUPERIORITY|||||||0.2241|||||||Chi-squared|||Discontinue without switch or restart||||0.2241
71785771|NCT03975790|143070038|SUPERIORITY|||||||0.0024|||||||Chi-squared|||Discontinue without switch or restart||||0.0024
71785772|NCT03975790|143070038|SUPERIORITY|||||||0.1204|||||||Chi-squared|||Discontinue without switch or restart||||0.1204
71785773|NCT03975790|143070039|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
71785774|NCT03975790|143070039|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
71785775|NCT03975790|143070039|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
71785776|NCT03975790|143070040|SUPERIORITY|||||||0.2036|||||||Chi-squared|||||||0.2036
71785777|NCT03975790|143070040|SUPERIORITY|||||||0.1336|||||||Chi-squared|||||||0.1336
71785778|NCT03975790|143070040|SUPERIORITY|||||||0.7095|||||||Chi-squared|||||||0.7095
71785779|NCT03975790|143070042|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<0.0001
71785780|NCT03975790|143070042|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
71785781|NCT03975790|143070042|SUPERIORITY||||||<|0.0001|||||||t-test|||||||<.0001
71785782|NCT03975790|143070043|SUPERIORITY|||||||0.0309|||||||Chi-squared|||Leflunomide||||0.0309
71785783|NCT03975790|143070043|SUPERIORITY|||||||0.9978|||||||Chi-squared|||Leflunomide||||0.9978
71785784|NCT03975790|143070043|SUPERIORITY|||||||0.2629|||||||Chi-squared|||Leflunomide||||0.2629
71785785|NCT03975790|143070043|SUPERIORITY|||||||0.0225|||||||Chi-squared|||Sulfasalazine||||0.0225
71785786|NCT03975790|143070043|SUPERIORITY|||||||0.4456|||||||Chi-squared|||Sulfasalazine||||0.4456
71785787|NCT03975790|143070043|SUPERIORITY|||||||0.5065|||||||Chi-squared|||Sulfasalazine||||0.5065
71785788|NCT03975790|143070043|SUPERIORITY|||||||0.6617|||||||Chi-squared|||Hydroxychloroquine||||0.6617
71785789|NCT03975790|143070043|SUPERIORITY|||||||0.7309|||||||Chi-squared|||Hydroxychloroquine||||0.7309
71785790|NCT03975790|143070043|SUPERIORITY|||||||0.9861|||||||Chi-squared|||Hydroxychloroquine||||0.9861
71785791|NCT03975790|143070044|SUPERIORITY|||||||0.088|||||||Chi-squared|||||||0.0880
71785792|NCT03975790|143070044|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71785793|NCT03975790|143070044|SUPERIORITY|||||||0.0065|||||||Chi-squared|||||||0.0065
71785794|NCT03975790|143070045|SUPERIORITY|||||||0.5157|||||||Chi-squared|||||||0.5157
71785795|NCT03975790|143070045|SUPERIORITY|||||||0.1231|||||||Chi-squared|||||||0.1231
71785796|NCT03975790|143070045|SUPERIORITY|||||||0.2109|||||||Chi-squared|||||||0.2109
71785797|NCT03975790|143070046|SUPERIORITY|||||||0.8424|||||||Chi-squared|||||||0.8424
71785798|NCT03975790|143070046|SUPERIORITY|||||||0.3278|||||||Chi-squared|||||||0.3278
71785799|NCT03975790|143070046|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
71785800|NCT03975790|143070047|SUPERIORITY|||||||0.0654|||||||Chi-squared|||||||0.0654
71785801|NCT03975790|143070047|SUPERIORITY|||||||0.7315|||||||Chi-squared|||||||0.7315
71785802|NCT03975790|143070047|SUPERIORITY|||||||0.1897|||||||Chi-squared|||||||0.1897
71785803|NCT03975790|143070048|SUPERIORITY|||||||0.5146|||||||Chi-squared|||||||0.5146
71785804|NCT03975790|143070048|SUPERIORITY|||||||0.7121|||||||Chi-squared|||||||0.7121
71785805|NCT03975790|143070048|SUPERIORITY|||||||0.4434|||||||Chi-squared|||||||0.4434
71785806|NCT03975790|143070049|SUPERIORITY|||||||0.8966|||||||Chi-squared|||||||0.8966
71785807|NCT03975790|143070049|SUPERIORITY|||||||0.2105|||||||Chi-squared|||||||0.2105
71785808|NCT03975790|143070049|SUPERIORITY|||||||0.3336|||||||Chi-squared|||||||0.3336
71785809|NCT03975790|143070051|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.3610
71785810|NCT03975790|143070051|SUPERIORITY|||||||0.4519|||||||Chi-squared|||||||0.4519
71785811|NCT03975790|143070051|SUPERIORITY|||||||0.9612|||||||Chi-squared|||||||0.9612
71785812|NCT03975790|143070052|SUPERIORITY|||||||0.8135|||||||Chi-squared|||||||0.8135
71785813|NCT03975790|143070052|SUPERIORITY|||||||0.591|||||||Chi-squared|||||||0.5910
71785814|NCT03975790|143070052|SUPERIORITY|||||||0.7635|||||||Chi-squared|||||||0.7635
71785815|NCT03975790|143070053|SUPERIORITY|||||||0.597|||||||Chi-squared|||||||0.5970
71785816|NCT03975790|143070053|SUPERIORITY|||||||0.7055|||||||Chi-squared|||||||0.7055
71785817|NCT03975790|143070054|SUPERIORITY|||||||0.5435|||||||Chi-squared|||||||0.5435
71785818|NCT03975790|143070054|SUPERIORITY|||||||0.679|||||||Chi-squared|||||||0.6790
71785819|NCT03975790|143070054|SUPERIORITY|||||||0.9676|||||||Chi-squared|||||||0.9676
71836456|NCT03175029|143178787|SUPERIORITY||Mean Difference (Final Values)|-0.826||||0.819|TWO_SIDED|95.0|-8.676|7.023|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BCI in the Placebo group||7.023|-8.676|0.819
71785820|NCT03975790|143070055|SUPERIORITY|||||||0.8035|||||||Chi-squared|||||||0.8035
71785821|NCT03975790|143070055|SUPERIORITY|||||||0.4184|||||||Chi-squared|||||||0.4184
71785822|NCT03975790|143070055|SUPERIORITY|||||||0.395|||||||Chi-squared|||||||0.3950
71785823|NCT03975790|143070057|SUPERIORITY|||||||0.7871|||||||Chi-squared|||||||0.7871
71785824|NCT03975790|143070057|SUPERIORITY|||||||0.0722|||||||Chi-squared|||||||0.0722
71785825|NCT03975790|143070057|SUPERIORITY|||||||0.181|||||||Chi-squared|||||||0.1810
71785826|NCT03975790|143070058|SUPERIORITY|||||||0.1984|||||||Chi-squared|||||||0.1984
71785827|NCT03975790|143070058|SUPERIORITY|||||||0.2043|||||||Chi-squared|||||||0.2043
71785828|NCT03975790|143070058|SUPERIORITY|||||||0.0439|||||||Chi-squared|||||||0.0439
71785829|NCT03975790|143070059|SUPERIORITY|||||||0.1702|||||||Chi-squared|||||||0.1702
71785830|NCT03975790|143070059|SUPERIORITY|||||||0.5926|||||||Chi-squared|||||||0.5926
71785831|NCT03975790|143070059|SUPERIORITY|||||||0.3088|||||||Chi-squared|||||||0.3088
71785832|NCT03975790|143070060|SUPERIORITY|||||||0.9141|||||||Chi-squared|||||||0.9141
71785833|NCT03975790|143070060|SUPERIORITY|||||||0.7623|||||||Chi-squared|||||||0.7623
71785834|NCT03975790|143070060|SUPERIORITY|||||||0.8517|||||||Chi-squared|||||||0.8517
71785835|NCT03975790|143070061|SUPERIORITY|||||||0.1208|||||||Chi-squared|||||||0.1208
71785836|NCT03975790|143070061|SUPERIORITY|||||||0.0425|||||||Chi-squared|||||||0.0425
71785837|NCT03975790|143070061|SUPERIORITY|||||||0.0046|||||||Chi-squared|||||||0.0046
71785838|NCT03975790|143070062|SUPERIORITY|||||||0.8698|||||||t-test|||||||0.8698
71785839|NCT03975790|143070062|SUPERIORITY|||||||0.7391|||||||t-test|||||||0.7391
71785840|NCT03975790|143070062|SUPERIORITY|||||||0.7043|||||||t-test|||||||0.7043
71785841|NCT03975790|143070063|SUPERIORITY|||||||0.0536|||||||t-test|||||||0.0536
71785842|NCT03975790|143070063|SUPERIORITY|||||||0.9313|||||||t-test|||||||0.9313
71785843|NCT03975790|143070063|SUPERIORITY|||||||0.374|||||||t-test|||||||0.3740
71785844|NCT03975790|143070064|SUPERIORITY|||||||0.6963|||||||t-test|||||||0.6963
71785845|NCT03975790|143070064|SUPERIORITY|||||||0.9816|||||||t-test|||||||0.9816
71785846|NCT03975790|143070064|SUPERIORITY|||||||0.8349|||||||t-test|||||||0.8349
71785847|NCT03975790|143070065|SUPERIORITY|||||||0.0003|||||||t-test|||||||0.0003
71785848|NCT03975790|143070065|SUPERIORITY|||||||0.9431|||||||t-test|||||||0.9431
71785849|NCT03975790|143070065|SUPERIORITY|||||||0.2964|||||||t-test|||||||0.2964
71785850|NCT03975790|143070066|SUPERIORITY|||||||0.2614|||||||t-test|||||||0.2614
71785851|NCT03975790|143070066|SUPERIORITY|||||||0.0014|||||||t-test|||||||0.0014
71785852|NCT03975790|143070066|SUPERIORITY|||||||0.0535|||||||t-test|||||||0.0535
71785853|NCT03975790|143070067|SUPERIORITY|||||||0.0051|||||||t-test|||1 months before index date||||0.0051
71785854|NCT03975790|143070067|SUPERIORITY|||||||0.3041|||||||t-test|||1 months before index date||||0.3041
71785855|NCT03975790|143070067|SUPERIORITY|||||||0.4432|||||||t-test|||1 months before index date||||0.4432
71785856|NCT03975790|143070067|SUPERIORITY|||||||0.8641|||||||t-test|||2 months before index date||||0.8641
71785857|NCT03975790|143070067|SUPERIORITY|||||||0.0435|||||||t-test|||2 months before index date||||0.0435
71785858|NCT03975790|143070067|SUPERIORITY|||||||0.153|||||||t-test|||2 months before index date||||0.1530
71785859|NCT03975790|143070067|SUPERIORITY|||||||0.1188|||||||t-test|||3 months before index date||||0.1188
71785860|NCT03975790|143070067|SUPERIORITY|||||||0.6807|||||||t-test|||3 months before index date||||0.6807
71785861|NCT03975790|143070067|SUPERIORITY|||||||0.1772|||||||t-test|||3 months before index date||||0.1772
71785862|NCT03975790|143070067|SUPERIORITY|||||||0.6104|||||||t-test|||4 months before index date||||0.6104
71785863|NCT03975790|143070067|SUPERIORITY|||||||0.9564|||||||t-test|||4 months before index date||||0.9564
71785864|NCT03975790|143070067|SUPERIORITY|||||||0.7688|||||||t-test|||4 months before index date||||0.7688
71785865|NCT03975790|143070067|SUPERIORITY|||||||0.5685|||||||t-test|||5 months before index date||||0.5685
71785866|NCT03975790|143070067|SUPERIORITY|||||||0.5122|||||||t-test|||5 months before index date||||0.5122
71785867|NCT03975790|143070067|SUPERIORITY|||||||0.4321|||||||t-test|||5 months before index date||||0.4321
71785868|NCT03975790|143070067|SUPERIORITY|||||||0.7892|||||||t-test|||6 months before index date||||0.7892
71785869|NCT03975790|143070067|SUPERIORITY|||||||0.2874|||||||t-test|||6 months before index date||||0.2874
71785870|NCT03975790|143070067|SUPERIORITY|||||||0.2662|||||||t-test|||6 months before index date||||0.2662
71785871|NCT03975790|143070067|SUPERIORITY|||||||0.3091|||||||t-test|||7 months before index date||||0.3091
71785872|NCT03975790|143070067|SUPERIORITY|||||||0.5783|||||||t-test|||7 months before index date||||0.5783
71785873|NCT03975790|143070067|SUPERIORITY|||||||0.4021|||||||t-test|||7 months before index date||||0.4021
71785874|NCT03975790|143070067|SUPERIORITY|||||||0.767|||||||t-test|||8 months before index date||||0.7670
71785875|NCT03975790|143070067|SUPERIORITY|||||||0.6978|||||||t-test|||8 months before index date||||0.6978
71785876|NCT03975790|143070067|SUPERIORITY|||||||0.6328|||||||t-test|||8 months before index date||||0.6328
71785877|NCT03975790|143070067|SUPERIORITY|||||||0.0541|||||||t-test|||9 months before index date||||0.0541
71785878|NCT03975790|143070067|SUPERIORITY|||||||0.6999|||||||t-test|||9 months before index date||||0.6999
71785879|NCT03975790|143070067|SUPERIORITY|||||||0.359|||||||t-test|||9 months before index date||||0.3590
71785880|NCT03975790|143070067|SUPERIORITY|||||||0.936|||||||t-test|||10 months before index date||||0.9360
71753408|NCT00772538|143009592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.032||0.0247||95.0|0.009|0.136||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.136|0.009|0.0247
71753409|NCT00772538|143009593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.043||0.0039||95.0|0.04|0.21||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.210|0.040|0.0039
71753410|NCT00772538|143009594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.19||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.190|0.031|0.0063
71753411|NCT00772538|143009595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.041||0.0027||95.0|0.042|0.201||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.201|0.042|0.0027
71785881|NCT03975790|143070067|SUPERIORITY|||||||0.626|||||||t-test|||10 months before index date||||0.6260
71785882|NCT03975790|143070067|SUPERIORITY|||||||0.7797|||||||t-test|||10 months before index date||||0.7797
71785883|NCT03975790|143070067|SUPERIORITY|||||||0.0934|||||||t-test|||11 months before index date||||0.0934
71785884|NCT03975790|143070067|SUPERIORITY|||||||0.396|||||||t-test|||11 months before index date||||0.3960
71753412|NCT00772538|143009596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.293|STANDARD_ERROR_OF_MEAN|4.584|<|0.0001||95.0|13.279|31.308||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||31.308|13.279|<0.0001
71785885|NCT03975790|143070067|SUPERIORITY|||||||0.4292|||||||t-test|||11 months before index date||||0.4292
71785886|NCT03975790|143070067|SUPERIORITY|||||||0.854|||||||t-test|||12 months before index date||||0.8540
71785887|NCT03975790|143070067|SUPERIORITY|||||||0.96|||||||t-test|||12 months before index date||||0.9600
71753413|NCT00772538|143009597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.267|STANDARD_ERROR_OF_MEAN|4.699|<|0.0001||95.0|14.027|32.507||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||32.507|14.027|<0.0001
71753414|NCT00772538|143009598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.061|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.173|0.061|<0.0001
71753415|NCT00772538|143009599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.068|0.181||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.181|0.068|<0.0001
71753416|NCT00772538|143009600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.736||0.7012||95.0|-1.165|1.731||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||1.731|-1.165|0.7012
71753417|NCT00772538|143009601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0499||95.0|0.49|1.0||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.00|0.49|0.0499
71753418|NCT00772538|143009602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71|STANDARD_ERROR_OF_MEAN|0.09||0.0102||95.0|0.55|0.92||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.92|0.55|0.0102
71753419|NCT00772538|143009603|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.64|STANDARD_ERROR_OF_MEAN|0.1||0.0062||95.0|0.46|0.88||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||0.88|0.46|0.0062
71753420|NCT00772538|143009604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0065||95.0|0.4|0.88||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.88|0.40|0.0065
71753421|NCT00772538|143009605|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.0561||95.0|0.42|1.01||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.01|0.42|0.0561
71753422|NCT00772538|143009606|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.5604||95.0|0.3|1.92||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium|||1.92|0.30|0.5604
71753423|NCT00772538|143009607|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.21||0.5538||95.0|0.54|1.39||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.39|0.54|0.5538
71753424|NCT00772538|143009608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.633||95.0|0.25|2.13||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.13|0.25|0.6330
71753425|NCT00772538|143009609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.074||0.5714||95.0|-0.103|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|-0.103|0.5714
71785888|NCT03975790|143070067|SUPERIORITY|||||||0.9374|||||||t-test|||12 months before index date||||0.9374
71753426|NCT00772538|143009610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.075||0.6099||95.0|-0.109|0.185||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.185|-0.109|0.6099
71753427|NCT00772538|143009611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.126|STANDARD_ERROR_OF_MEAN|0.066||0.0586||95.0|-0.256|0.005||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.005|-0.256|0.0586
71753428|NCT00772538|143009612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.067||0.0727||95.0|-0.253|0.011||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.011|-0.253|0.0727
71753429|NCT00772538|143009613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.024||0.9807||95.0|-0.048|0.047||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.047|-0.048|0.9807
71753430|NCT00772538|143009614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.172||0.5927||95.0|-0.43|0.246||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.246|-0.430|0.5927
71753431|NCT00772538|143009615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
71753432|NCT00772538|143009615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
71753433|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.692||||||For ILC|ANCOVA|||||||0.692
71753434|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.467||||||For ILC|ANCOVA|||||||0.467
71753435|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.281||||||For ILC|ANCOVA|||||||0.281
71753436|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.075||||||For ILC|ANCOVA|||||||0.075
71753437|NCT00713609|143009616|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
71753438|NCT00713609|143009616|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71753439|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.803||||||For NILC|ANCOVA|||||||0.803
71753440|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.175||||||For NILC|ANCOVA|||||||0.175
71753441|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.552||||||For NILC|ANCOVA|||||||0.552
71753442|NCT00713609|143009616|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71753443|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
71753444|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.618||||||For TC|ANCOVA|||||||0.618
71753445|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.149||||||For TC|ANCOVA|||||||0.149
71753446|NCT00713609|143009616|SUPERIORITY_OR_OTHER|||||||0.255||||||For TC|ANCOVA|||||||0.255
71753447|NCT00713609|143009616|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
71753448|NCT00713609|143009617|SUPERIORITY_OR_OTHER|||||||0.922|||||||Cochran-Mantel-Haenszel|||||||0.922
71753449|NCT00713609|143009617|SUPERIORITY_OR_OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
71753450|NCT00713609|143009617|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
71753451|NCT00713609|143009617|SUPERIORITY_OR_OTHER|||||||0.706|||||||Cochran-Mantel-Haenszel|||||||0.706
71753452|NCT00713609|143009617|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||||||0.009
71753453|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
71753454|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.504||||||For ILC|ANCOVA|||||||0.504
71753455|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.177||||||For ILC|ANCOVA|||||||0.177
71753456|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.084||||||For ILC|ANCOVA|||||||0.084
71753457|NCT00713609|143009618|SUPERIORITY_OR_OTHER||||||<|0.001||||||For ILC|ANCOVA|||||||<0.001
71753458|NCT00713609|143009618|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71753459|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.776||||||For NILC|ANCOVA|||||||0.776
71753460|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.465||||||For NILC|ANCOVA|||||||0.465
71753461|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.288||||||For NILC|ANCOVA|||||||0.288
71753462|NCT00713609|143009618|SUPERIORITY_OR_OTHER||||||<|0.001||||||For NILC|ANCOVA|||||||<0.001
71753463|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.006||||||For TC|ANCOVA|||||||0.006
71753464|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.62||||||For TC|ANCOVA|||||||0.620
71753465|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.291||||||For TC|ANCOVA|||||||0.291
71753466|NCT00713609|143009618|SUPERIORITY_OR_OTHER|||||||0.085||||||For TC|ANCOVA|||||||0.085
71785889|NCT03975790|143070067|SUPERIORITY|||||||0.6674|||||||t-test|||1 month after index date||||0.6674
71785890|NCT03975790|143070067|SUPERIORITY|||||||0.0776|||||||t-test|||1 month after index date||||0.0776
71785891|NCT03975790|143070067|SUPERIORITY|||||||0.335|||||||t-test|||1 month after index date||||0.3350
71785892|NCT03975790|143070067|SUPERIORITY|||||||0.8461|||||||t-test|||2 month after index date||||0.8461
71785893|NCT03975790|143070067|SUPERIORITY|||||||0.8111|||||||t-test|||2 month after index date||||0.8111
71785894|NCT03975790|143070067|SUPERIORITY|||||||0.7267|||||||t-test|||2 month after index date||||0.7267
71785895|NCT03975790|143070067|SUPERIORITY|||||||0.2453|||||||t-test|||3 month after index date||||0.2453
71836457|NCT03175029|143178787|SUPERIORITY||Mean Difference (Final Values)|11.378|STANDARD_ERROR_OF_MEAN|4.454||0.015|TWO_SIDED|95.0|2.345|20.411|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BCI from baseline to Week 12||20.411|2.345|0.015
71669538|NCT01037218|142856395|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.9|2.16|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.16|0.90|<0.0001
71669539|NCT01037218|142856395|SUPERIORITY_OR_OTHER||Difference in LS Means|1.53|||<|0.0001|TWO_SIDED|95.0|0.91|2.15|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.15|0.91|<0.0001
71669540|NCT01037218|142856396|SUPERIORITY_OR_OTHER||Difference in LS Means|0.36||||0.0566|TWO_SIDED|95.0|-0.01|0.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.73|-0.01|0.0566
71669541|NCT01037218|142856396|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0002|TWO_SIDED|95.0|0.34|1.08|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.08|0.34|0.0002
71669542|NCT01037218|142856396|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.0001|TWO_SIDED|95.0|0.34|1.07|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.07|0.34|0.0001
71669543|NCT01037218|142856397|SUPERIORITY_OR_OTHER||Difference in LS Means|0.86||||0.0019|TWO_SIDED|95.0|0.32|1.4|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||1.40|0.32|0.0019
71669544|NCT01037218|142856397|SUPERIORITY_OR_OTHER||Difference in LS Means|1.55|||<|0.0001|TWO_SIDED|95.0|1.01|2.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.09|1.01|<0.0001
71669545|NCT01037218|142856397|SUPERIORITY_OR_OTHER||Difference in LS Means|2.09|||<|0.0001|TWO_SIDED|95.0|1.55|2.62|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||2.62|1.55|<0.0001
71669546|NCT01037218|142856398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71836458|NCT03175029|143178788|SUPERIORITY||Mean Difference (Final Values)|10.604|STANDARD_DEVIATION|8.76|<|0.001|TWO_SIDED|95.0|5.753|15.455|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the TAC-302 group||15.455|5.753|<0.001
71836459|NCT03175029|143178788|SUPERIORITY||Mean Difference (Final Values)|4.926|STANDARD_DEVIATION|7.62||0.138|TWO_SIDED|95.0|-2.121|11.973|||t-test, 2 sided|||Baseline vs. Week 12 for the mean PIP1 in the Placebo group||11.973|-2.121|0.138
71753467|NCT00713609|143009618|SUPERIORITY_OR_OTHER||||||<|0.001||||||For TC|ANCOVA|||||||<0.001
71753468|NCT00713609|143009619|SUPERIORITY_OR_OTHER|||||||0.652|||||||Cochran-Mantel-Haenszel|||||||0.652
71753469|NCT00713609|143009619|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|||||||0.279
71669547|NCT01037218|142856398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71669548|NCT01037218|142856398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71669549|NCT01037218|142856398|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||||<0.0001
71669550|NCT01037218|142856399|SUPERIORITY_OR_OTHER||Difference in LS Means|12.65|||<|0.0001|TWO_SIDED|95.0|7.01|18.29|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||18.29|7.01|<0.0001
71669551|NCT01037218|142856399|SUPERIORITY_OR_OTHER||Difference in LS Means|19.61|||<|0.0001|TWO_SIDED|95.0|13.95|25.27|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.27|13.95|<0.0001
71669552|NCT01037218|142856399|SUPERIORITY_OR_OTHER||Difference in LS Means|27.01|||<|0.0001|TWO_SIDED|95.0|21.44|32.59|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||32.59|21.44|<0.0001
71669553|NCT01037218|142856400|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.57|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.57|0.30|<0.0001
71785896|NCT03975790|143070067|SUPERIORITY|||||||0.5889|||||||t-test|||3 month after index date||||0.5889
71785897|NCT03975790|143070067|SUPERIORITY|||||||0.4162|||||||t-test|||3 month after index date||||0.4162
71785898|NCT03975790|143070067|SUPERIORITY|||||||0.0307|||||||t-test|||4 month after index date||||0.0307
71785899|NCT03975790|143070067|SUPERIORITY|||||||0.1147|||||||t-test|||4 month after index date||||0.1147
71785900|NCT03975790|143070067|SUPERIORITY|||||||0.9481|||||||t-test|||4 month after index date||||0.9481
71785901|NCT03975790|143070067|SUPERIORITY|||||||0.4455|||||||t-test|||5 month after index date||||0.4455
71785902|NCT03975790|143070067|SUPERIORITY|||||||0.9445|||||||t-test|||5 month after index date||||0.9445
71785903|NCT03975790|143070067|SUPERIORITY|||||||0.6191|||||||t-test|||5 month after index date||||0.6191
71785904|NCT03975790|143070067|SUPERIORITY|||||||0.0805|||||||t-test|||6 month after index date||||0.0805
71785905|NCT03975790|143070067|SUPERIORITY|||||||0.7037|||||||t-test|||6 month after index date||||0.7037
71785906|NCT03975790|143070067|SUPERIORITY|||||||0.4288|||||||t-test|||6 month after index date||||0.4288
71785907|NCT03975790|143070067|SUPERIORITY|||||||0.3731|||||||t-test|||7 month after index date||||0.3731
71785908|NCT03975790|143070067|SUPERIORITY|||||||0.4803|||||||t-test|||7 month after index date||||0.4803
71785909|NCT03975790|143070067|SUPERIORITY|||||||0.5831|||||||t-test|||7 month after index date||||0.5831
71785910|NCT03975790|143070067|SUPERIORITY|||||||0.0944|||||||t-test|||8 month after index date||||0.0944
71785911|NCT03975790|143070067|SUPERIORITY|||||||0.88|||||||t-test|||8 month after index date||||0.8800
71785912|NCT03975790|143070067|SUPERIORITY|||||||0.4949|||||||t-test|||8 month after index date||||0.4949
71785913|NCT03975790|143070067|SUPERIORITY|||||||0.6373|||||||t-test|||9 month after index date||||0.6373
71785914|NCT03975790|143070067|SUPERIORITY|||||||0.0497|||||||t-test|||9 month after index date||||0.0497
71785915|NCT03975790|143070067|SUPERIORITY|||||||0.1695|||||||t-test|||9 month after index date||||0.1695
71785916|NCT03975790|143070067|SUPERIORITY|||||||0.6373|||||||t-test|||10 month after index date||||0.6373
71785917|NCT03975790|143070067|SUPERIORITY|||||||0.7866|||||||t-test|||10 month after index date||||0.7866
71785918|NCT03975790|143070067|SUPERIORITY|||||||0.7643|||||||t-test|||10 months after index date||||0.7643
71785919|NCT03975790|143070067|SUPERIORITY|||||||0.2307|||||||t-test|||11 month after index date||||0.2307
71785920|NCT03975790|143070067|SUPERIORITY|||||||0.6712|||||||t-test|||11 month after index date||||0.6712
71785921|NCT03975790|143070067|SUPERIORITY|||||||0.6953|||||||t-test|||11 months after index date||||0.6953
71785922|NCT03975790|143070067|SUPERIORITY|||||||0.3675|||||||t-test|||12 month after index date||||0.3675
71785923|NCT03975790|143070067|SUPERIORITY|||||||0.8027|||||||t-test|||12 month after index date||||0.8027
71785924|NCT03975790|143070067|SUPERIORITY|||||||0.4817|||||||t-test|||12 month after index date||||0.4817
71785925|NCT03975790|143070068|SUPERIORITY|||||||0.0063|||||||t-test|||1 month before index date||||0.0063
71785926|NCT03975790|143070068|SUPERIORITY|||||||0.0162|||||||t-test|||1 month before index date||||0.0162
71785927|NCT03975790|143070068|SUPERIORITY|||||||0.8715|||||||t-test|||1 month before index date||||0.8715
71785928|NCT03975790|143070068|SUPERIORITY|||||||0.2799|||||||t-test|||2 months before index date||||0.2799
71669554|NCT01037218|142856400|SUPERIORITY_OR_OTHER||Difference in LS Means|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.68|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.68|0.40|<0.0001
71753470|NCT00713609|143009619|SUPERIORITY_OR_OTHER|||||||0.312|||||||Cochran-Mantel-Haenszel|||||||0.312
71753471|NCT00713609|143009619|SUPERIORITY_OR_OTHER|||||||0.063|||||||Cochran-Mantel-Haenszel|||||||0.063
71785929|NCT03975790|143070068|SUPERIORITY|||||||0.0126|||||||t-test|||2 months before index date||||0.0126
71753472|NCT00713609|143009619|SUPERIORITY_OR_OTHER|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71753473|NCT01903356|143009620|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.|The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration|||<0.0001
71753474|NCT01903356|143009623|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment|The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration|||<0.0001
71785930|NCT03975790|143070068|SUPERIORITY|||||||0.2126|||||||t-test|||2 months before index date||||0.2126
71785931|NCT03975790|143070068|SUPERIORITY|||||||0.7004|||||||t-test|||3 months before index date||||0.7004
71785932|NCT03975790|143070068|SUPERIORITY|||||||0.1476|||||||t-test|||3 months before index date||||0.1476
71753475|NCT04529083|143009625|OTHER||Mean Difference (Net)|-0.625||||0.011|TWO_SIDED|95.0|-1.06|-0.19|||t-test, 2 sided|||||-0.19|-1.06|0.011
71753476|NCT04529083|143009627|SUPERIORITY||Mean Difference (Net)|1.94||||0.006|TWO_SIDED|95.0|0.63|3.26|||t-test, 2 sided|||||3.26|0.63|0.006
71753477|NCT03305666|143009628|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||||||0.12
71753478|NCT03305666|143009629|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.41|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #1.||||0.41
71753479|NCT03305666|143009629|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.25|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #2.||||0.25
71753480|NCT03305666|143009629|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.12|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #3.||||0.12
71753481|NCT03305666|143009629|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.04|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #4.||||0.04
71753482|NCT03305666|143009629|NON_INFERIORITY|Statistical analyses were conducted using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.32|||||||ANOVA|||This is the P-Value for between groups comparison of Postoperative Day #5.||||0.32
71753483|NCT03305666|143009630|NON_INFERIORITY|Statistical analyses were conduced using SAS version 9.4. This non-inferiority test was conducted via a one-way ANOVA test, with statistical significance set at p \< 0.05.||||||0.23|||||||ANOVA|||||||0.23
71753484|NCT04196686|143009634|OTHER||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.25|0.51|||Cox mixed effects model|||||0.51|0.25|<0.001
71753485|NCT04196686|143009635|OTHER||Mean Difference (Net)|0.455||||0.2|TWO_SIDED|95.0|0.32|0.59|||Linear mixed effects model|||Analysis was controlled for dominant hand treatment assignment, dominant hand order, and gender. Overall mean difference calculated from regression model.||0.59|0.32|0.200
71785933|NCT03975790|143070068|SUPERIORITY|||||||0.2057|||||||t-test|||3 months before index date||||0.2057
71785934|NCT03975790|143070068|SUPERIORITY|||||||0.2905|||||||t-test|||4 months before index date||||0.2905
71785935|NCT03975790|143070068|SUPERIORITY|||||||0.8273|||||||t-test|||4 months before index date||||0.8273
71785936|NCT03975790|143070068|SUPERIORITY|||||||0.627|||||||t-test|||4 months before index date||||0.6270
71785937|NCT03975790|143070068|SUPERIORITY|||||||0.3256|||||||t-test|||5 months before index date||||0.3256
71785938|NCT03975790|143070068|SUPERIORITY|||||||0.5631|||||||t-test|||5 months before index date||||0.5631
71785939|NCT03975790|143070068|SUPERIORITY|||||||0.4491|||||||t-test|||5 months before index date||||0.4491
71785940|NCT03975790|143070068|SUPERIORITY|||||||0.2009|||||||t-test|||6 months before index date||||0.2009
71785941|NCT03975790|143070068|SUPERIORITY|||||||0.3011|||||||t-test|||6 months before index date||||0.3011
71669555|NCT01037218|142856400|SUPERIORITY_OR_OTHER||Difference in LS Means|0.83|||<|0.0001|TWO_SIDED|95.0|0.69|0.97|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||0.97|0.69|<0.0001
71669556|NCT01037218|142856401|SUPERIORITY_OR_OTHER||Difference in LS Means|15.18|||<|0.0001|TWO_SIDED|95.0|10.21|20.14|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||20.14|10.21|<0.0001
71669557|NCT01037218|142856401|SUPERIORITY_OR_OTHER||Difference in LS Means|14.94|||<|0.0001|TWO_SIDED|95.0|9.96|19.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||19.92|9.96|<0.0001
71669558|NCT01037218|142856401|SUPERIORITY_OR_OTHER||Difference in LS Means|21.06|||<|0.0001|TWO_SIDED|95.0|16.15|25.96|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||25.96|16.15|<0.0001
71669559|NCT01037218|142856402|SUPERIORITY_OR_OTHER||Difference in LS Means|17.51|||<|0.0001|TWO_SIDED|95.0|10.22|24.81|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||24.81|10.22|<0.0001
71669560|NCT01037218|142856402|SUPERIORITY_OR_OTHER||Difference in LS Means|28.32|||<|0.0001|TWO_SIDED|95.0|21.01|35.62|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||35.62|21.01|<0.0001
71785942|NCT03975790|143070068|SUPERIORITY|||||||0.2065|||||||t-test|||6 months before index date||||0.2065
71785943|NCT03975790|143070068|SUPERIORITY|||||||0.6098|||||||t-test|||7 months before index date||||0.6098
71785944|NCT03975790|143070068|SUPERIORITY|||||||0.2586|||||||t-test|||7 months before index date||||0.2586
71785945|NCT03975790|143070068|SUPERIORITY|||||||0.4074|||||||t-test|||7 months before index date||||0.4074
71785946|NCT03975790|143070068|SUPERIORITY|||||||0.0345|||||||t-test|||8 months before index date||||0.0345
71785947|NCT03975790|143070068|SUPERIORITY|||||||0.4377|||||||t-test|||8 months before index date||||0.4377
71785948|NCT03975790|143070068|SUPERIORITY|||||||0.7191|||||||t-test|||8 months before index date||||0.7191
71785949|NCT03975790|143070068|SUPERIORITY|||||||0.0199|||||||t-test|||9 months before index date||||0.0199
71785950|NCT03975790|143070068|SUPERIORITY|||||||0.1032|||||||t-test|||9 months before index date||||0.1032
71785951|NCT03975790|143070068|SUPERIORITY|||||||0.904|||||||t-test|||9 months before index date||||0.9040
71836460|NCT03175029|143178788|SUPERIORITY||Mean Difference (Final Values)|5.678|STANDARD_ERROR_OF_MEAN|3.861||0.157|TWO_SIDED|95.0|-2.375|13.731|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12||13.731|-2.375|0.157
71785952|NCT03975790|143070068|SUPERIORITY|||||||0.0316|||||||t-test|||10 months before index date||||0.0316
71785953|NCT03975790|143070068|SUPERIORITY|||||||0.6748|||||||t-test|||10 months before index date||||0.6748
71785954|NCT03975790|143070068|SUPERIORITY|||||||0.2679|||||||t-test|||10 months before index date||||0.2679
71785955|NCT03975790|143070068|SUPERIORITY|||||||0.501|||||||t-test|||11 months before index date||||0.5010
71785956|NCT03975790|143070068|SUPERIORITY|||||||0.3228|||||||t-test|||11 months before index date||||0.3228
71785957|NCT03975790|143070068|SUPERIORITY|||||||0.7881|||||||t-test|||11 months before index date||||0.7881
71785958|NCT03975790|143070068|SUPERIORITY|||||||0.0876|||||||t-test|||12 months before index date||||0.0876
71785959|NCT03975790|143070068|SUPERIORITY|||||||0.1226|||||||t-test|||12 months before index date||||0.1226
71785960|NCT03975790|143070068|SUPERIORITY|||||||0.9753|||||||t-test|||12 months before index date||||0.9753
71785961|NCT03975790|143070068|SUPERIORITY|||||||0.0336|||||||t-test|||1 month after index date||||0.0336
71785962|NCT03975790|143070068|SUPERIORITY|||||||0.2551|||||||t-test|||1 month after index date||||0.2551
71785963|NCT03975790|143070068|SUPERIORITY|||||||0.6189|||||||t-test|||1 month after index date||||0.6189
71836461|NCT03175029|143178789|SUPERIORITY||Mean Difference (Final Values)|10.91|STANDARD_DEVIATION|26.48||0.006|TWO_SIDED|95.0|3.22|18.59|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||18.59|3.22|0.006
71836462|NCT03175029|143178789|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_DEVIATION|20.09||0.57|TWO_SIDED|95.0|-6.27|11.1|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.10|-6.27|0.570
71669561|NCT01037218|142856402|SUPERIORITY_OR_OTHER||Difference in LS Means|33.82|||<|0.0001|TWO_SIDED|95.0|26.61|41.02|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||41.02|26.61|<0.0001
71677159|NCT03557931|142872898|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.02||0.858|TWO_SIDED|90.0|-1.51|1.88|||MMRM Method|||Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (least square (LS) Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 50 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 50 mg vs placebo is 0.035.|1.88|-1.51|0.858
71836463|NCT03175029|143178789|SUPERIORITY||Mean Difference (Final Values)|8.49|STANDARD_ERROR_OF_MEAN|6.24||0.178|TWO_SIDED|95.0|-3.96|20.95|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||20.95|-3.96|0.178
71836464|NCT03175029|143178790|SUPERIORITY||Mean Difference (Final Values)|18.41|STANDARD_DEVIATION|24.39|<|0.001|TWO_SIDED|95.0|9.13|27.69|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||27.69|9.13|<0.001
71836465|NCT03175029|143178790|SUPERIORITY||Mean Difference (Final Values)|2.88|STANDARD_DEVIATION|15.7||0.489|TWO_SIDED|95.0|-5.81|11.58|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||11.58|-5.81|0.489
71836466|NCT03175029|143178790|SUPERIORITY||Mean Difference (Final Values)|15.53|STANDARD_ERROR_OF_MEAN|6.96||0.031|TWO_SIDED|95.0|1.48|29.58|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||29.58|1.48|0.031
71836467|NCT03175029|143178791|SUPERIORITY||Mean Difference (Final Values)|23.57|STANDARD_DEVIATION|25.54|<|0.001|TWO_SIDED|95.0|11.26|35.88|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the TAC-302 group||35.88|11.26|<0.001
71836468|NCT03175029|143178791|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|17.18||0.708|TWO_SIDED|95.0|-10.19|14.4|||t-test, 2 sided|||Baseline vs. Week 12 for the mean BVE in the Placebo group||14.40|-10.19|0.708
71836469|NCT03175029|143178791|SUPERIORITY||Mean Difference (Final Values)|21.47|STANDARD_ERROR_OF_MEAN|9.02||0.025|TWO_SIDED|95.0|2.96|39.98|||t-test, 2 sided|||TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12||39.98|2.96|0.025
71836470|NCT02384317|143178816|SUPERIORITY||Slope|-2.4|STANDARD_DEVIATION|141.77||0.965|TWO_SIDED|95.0|-133.6|128.7|||Random coefficients regression|||||128.7|-133.6|0.965
71836471|NCT05956002|143178866|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.66|||||TWO_SIDED|90.0|91.33|98.12|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2mg mini tablets in applesauce vs etrasimod 2mg clinical IR tablet mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.12|91.33|
71836472|NCT05956002|143178866|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.96|||||TWO_SIDED|90.0|91.69|98.34|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.34|91.69|
71836473|NCT05956002|143178866|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.86|||||TWO_SIDED|90.0|82.9|88.92|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.92|82.90|
71836474|NCT05956002|143178866|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUClast for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.24|||||TWO_SIDED|90.0|89.76|96.84|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||96.84|89.76|
71836475|NCT05956002|143178867|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.36|||||TWO_SIDED|90.0|90.97|97.89|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.89|90.97|
71669562|NCT01037218|142856403|SUPERIORITY_OR_OTHER||Difference in LS Means|18.73|||<|0.0001|TWO_SIDED|95.0|11.23|26.23|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||26.23|11.23|<0.0001
71836476|NCT05956002|143178867|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.75|||||TWO_SIDED|90.0|91.41|98.2|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||98.20|91.41|
71836477|NCT05956002|143178867|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|85.44|||||TWO_SIDED|90.0|82.43|88.55|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||88.55|82.43|
71836478|NCT05956002|143178867|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of AUCinf for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|93.28|||||TWO_SIDED|90.0|89.61|97.1|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.10|89.61|
71836479|NCT05956002|143178868|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with applesauce (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|94.7|||||TWO_SIDED|90.0|90.38|99.22|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in applesauce vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||99.22|90.38|
71836480|NCT05956002|143178868|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with chocolate pudding (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.72|||||TWO_SIDED|90.0|88.59|97.04|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in chocolate pudding vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.04|88.59|
71836481|NCT05956002|143178868|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with water (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|87.24|||||TWO_SIDED|90.0|83.35|91.31|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in water vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||91.31|83.35|
71836482|NCT05956002|143178868|EQUIVALENCE|For bioequivalence, the 90% CIs of the adjusted geometric mean ratio of Cmax for etrasimod 2 mg mini tablets mixed with yogurt (tests) compared with etrasimod 2 mg clinical IR tablet (reference) were required to be within the 80 to 125% range.|Ratio of adjusted geometric means|92.59|||||TWO_SIDED|90.0|88.24|97.17|||||The ratio and 90% CIs are expressed as percentages.|Analysis was performed for etrasimod 2 mg mini tablets in yogurt vs etrasimod 2 mg clinical IR tablet using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||97.17|88.24|
71836483|NCT04391894|143178933|SUPERIORITY||Least Squares Mean (LS Mean)|-1.1|STANDARD_ERROR_OF_MEAN|2.01||0.585|TWO_SIDED|95.0|-5.0|2.8|||Mixed Models Analysis|||||2.8|-5.0|0.585
71836484|NCT04391894|143178933|SUPERIORITY||Least Squares Mean (LS Mean)|-3.2|STANDARD_ERROR_OF_MEAN|2.0||0.107|TWO_SIDED|95.0|-7.01|0.7|||Mixed Models Analysis|||||0.7|-7.01|0.107
71891880|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.3|
71677160|NCT03557931|142872898|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-1.93|1.36|||0.775|||MMRM analysis model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at week 12 as response; treatment, site (pooled where necessary), visit, treatment\*visit, and visit\*baseline as fixed effects, and baseline as a covariate.|Cohen's d Effect Size was defined as: (t-value for the least squares mean pairwise difference of ASP4345 150 mg vs placebo) \* sqrt(1/n\[PLACEBO\] + 1/n\[ASP4345\]). The Cohen's d Effect Size value for ASP4345 150 mg vs placebo is - 0.053.|1.36|-1.93|
71891881|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.1|
71836485|NCT04391894|143178933|SUPERIORITY||Least Squares Mean (LS Mean)|4.3|STANDARD_ERROR_OF_MEAN|2.02||0.033|TWO_SIDED|95.0|0.3|8.3|||Mixed Models Analysis|||||8.3|0.3|0.033
71669563|NCT01037218|142856403|SUPERIORITY_OR_OTHER||Difference in LS Means|29.39|||<|0.0001|TWO_SIDED|95.0|21.86|36.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).||36.92|21.86|<0.0001
71677161|NCT03557931|142872904|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|1.6||0.639|TWO_SIDED|90.0|-1.9|3.41|||ANCOVA|||Analysis of covariance (ANCOVA) model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||3.41|-1.90|0.639
71753486|NCT04196686|143009636|OTHER||Mean Difference (Net)|0.002||||0.047|TWO_SIDED|95.0|0.00007|0.00368|||Linear mixed effects model|||The variables in the physiologic model were SCRD change over time and the SCRD change between groups, defined as those with and without VR.||0.00368|0.00007|0.047
71753487|NCT02587221|143009643|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|19.8|||||TWO_SIDED|97.45|-5.27|38.91|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||38.91|-5.27|
71753488|NCT02587221|143009648|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as the presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|32.12|||||TWO_SIDED|95.0|10.23|48.67|||Regression, Cox|Adjusted for covariates||||48.67|10.23|
71785964|NCT03975790|143070068|SUPERIORITY|||||||0.7051|||||||t-test|||2 months after index date||||0.7051
71785965|NCT03975790|143070068|SUPERIORITY|||||||0.9775|||||||t-test|||2 months after index date||||0.9775
71785966|NCT03975790|143070068|SUPERIORITY|||||||0.7643|||||||t-test|||2 months after index date||||0.7643
71785967|NCT03975790|143070068|SUPERIORITY|||||||0.2953|||||||t-test|||3 months after index date||||0.2953
71785968|NCT03975790|143070068|SUPERIORITY|||||||0.6257|||||||t-test|||3 months after index date||||0.6257
71785969|NCT03975790|143070068|SUPERIORITY|||||||0.4753|||||||t-test|||3 months after index date||||0.4753
71836486|NCT04391894|143178934|SUPERIORITY||Least Squares Mean (LS Mean)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.605|TWO_SIDED|95.0|-0.8|0.4|||Mixed Models Analysis|||||0.4|-0.8|0.605
71836487|NCT04391894|143178934|SUPERIORITY||Least Squares Mean (LS Mean)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.646|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.646
71836488|NCT04391894|143178934|SUPERIORITY||Least Squares Mean (LS Mean)|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.847|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.847
71785970|NCT03975790|143070068|SUPERIORITY|||||||0.0926|||||||t-test|||4 months after index date||||0.0926
71785971|NCT03975790|143070068|SUPERIORITY|||||||0.0013|||||||t-test|||4 months after index date||||0.0013
71785972|NCT03975790|143070068|SUPERIORITY|||||||0.0065|||||||t-test|||4 months after index date||||0.0065
71785973|NCT03975790|143070068|SUPERIORITY|||||||0.2212|||||||t-test|||5 months after index date||||0.2212
71785974|NCT03975790|143070068|SUPERIORITY|||||||0.9688|||||||t-test|||5 months after index date||||0.9688
71785975|NCT03975790|143070068|SUPERIORITY|||||||0.5647|||||||t-test|||5 months after index date||||0.5647
71785976|NCT03975790|143070068|SUPERIORITY|||||||0.0023|||||||t-test|||6 months after index date||||0.0023
71785977|NCT03975790|143070068|SUPERIORITY|||||||0.1142|||||||t-test|||6 months after index date||||0.1142
71785978|NCT03975790|143070068|SUPERIORITY|||||||0.3842|||||||t-test|||6 months after index date||||0.3842
71785979|NCT03975790|143070068|SUPERIORITY|||||||0.9097|||||||t-test|||7 months after index date||||0.9097
71785980|NCT03975790|143070068|SUPERIORITY|||||||0.3885|||||||t-test|||7 months after index date||||0.3885
71785981|NCT03975790|143070068|SUPERIORITY|||||||0.3834|||||||t-test|||7 months after index date||||0.3834
71785982|NCT03975790|143070068|SUPERIORITY|||||||0.3075|||||||t-test|||8 months after index date||||0.3075
71785983|NCT03975790|143070068|SUPERIORITY|||||||0.9075|||||||t-test|||8 months after index date||||0.9075
71785984|NCT03975790|143070068|SUPERIORITY|||||||0.5993|||||||t-test|||8 months after index date||||0.5993
71785985|NCT03975790|143070068|SUPERIORITY|||||||0.0775|||||||t-test|||9 months after index date||||0.0775
71785986|NCT03975790|143070068|SUPERIORITY|||||||0.1536|||||||t-test|||9 months after index date||||0.1536
71785987|NCT03975790|143070068|SUPERIORITY|||||||0.8553|||||||t-test|||9 months after index date||||0.8553
71785988|NCT03975790|143070068|SUPERIORITY|||||||0.6295|||||||t-test|||10 months after index date||||0.6295
71785989|NCT03975790|143070068|SUPERIORITY|||||||0.0551|||||||t-test|||10 months after index date||||0.0551
71785990|NCT03975790|143070068|SUPERIORITY|||||||0.2215|||||||t-test|||10 months after index date||||0.2215
71785991|NCT03975790|143070068|SUPERIORITY|||||||0.1948|||||||t-test|||11 months after index date||||0.1948
71785992|NCT03975790|143070068|SUPERIORITY|||||||0.6621|||||||t-test|||11 months after index date||||0.6621
71785993|NCT03975790|143070068|SUPERIORITY|||||||0.6629|||||||t-test|||11 months after index date||||0.6629
71785994|NCT03975790|143070068|SUPERIORITY|||||||0.5699|||||||t-test|||12 months after index date||||0.5699
71785995|NCT03975790|143070068|SUPERIORITY|||||||0.7105|||||||t-test|||12 months after index date||||0.7105
71836489|NCT04391894|143178935|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
71836490|NCT04391894|143178935|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
71836491|NCT04391894|143178935|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
71669564|NCT01037218|142856403|SUPERIORITY_OR_OTHER||Difference in LS Means|34.35|||<|0.0001|TWO_SIDED|95.0|26.94|41.75|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).||41.75|26.94|<0.0001
71669565|NCT02676882|142856404|OTHER|A Chi Squared analysis was performed to determine how the rate of relapse in Group 1 (27.3%) compared to that of historical controls in the literature (67.7%). (Cohen, JAMA 2006)||||||0.005||||||A priori threshold for statistical significance: p\<0.05|Chi-squared|||||||0.005
71669566|NCT02676882|142856405|OTHER|A one-way repeated measures ANOVA was used to examine the overall course of Group 2 participants' MADRS scores. (F(6, 29)=5.16, p=0.001).||||||0.001||||||a priori threshold for statistical significance: p \<0.05|ANOVA|||||||0.001
71669567|NCT02568072|142856406|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71669568|NCT02568072|142856407|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71669569|NCT02568072|142856408|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
71669570|NCT00707239|142856450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.4|||||TWO_SIDED|70.0|-21.6|10.9||||||Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||10.9|-21.6|
71669571|NCT00707239|142856450|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.0|||||TWO_SIDED|70.0|-6.1|24.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||24.8|-6.1|
71669572|NCT00707239|142856451|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2|||||TWO_SIDED|70.0|-14.3|14.0||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||14.0|-14.3|
71669573|NCT00707239|142856451|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5|||||TWO_SIDED|70.0|4.3|31.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||31.8|4.3|
71669574|NCT00707239|142856454|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-18.5|||||TWO_SIDED|70.0|-39.6|4.2||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||4.2|-39.6|
71669575|NCT00707239|142856454|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|70.0|-23.8|20.9||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.||20.9|-23.8|
71669576|NCT00707239|142856455|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Nausea: p-value was calculated using 2-tail Fischer's exact test.||||0.527
71669577|NCT00707239|142856455|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||Vomiting: p-value was calculated using 2-tail Fischer's exact test.||||0.390
71785996|NCT03975790|143070068|SUPERIORITY|||||||0.5965|||||||t-test|||12 months after index date||||0.5965
71785997|NCT01059825|143070093|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0.002|TWO_SIDED|80.0|-0.65|-0.25||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.25|-0.65|0.002
71785998|NCT01059825|143070093|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0|TWO_SIDED|80.0|-0.89|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.49|-0.89|0.000
71836492|NCT04391894|143178936|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
71669578|NCT00707239|142856456|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
71669579|NCT00707239|142856457|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.||||1.000
71669580|NCT00707239|142856463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0479||||0.78|TWO_SIDED|95.0|0.754|1.46|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced nausea and did not experience nausea.||1.46|0.754|0.78
71669581|NCT00707239|142856463|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84644||||0.356|TWO_SIDED|95.0|0.593|1.21|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced vomiting and did not experience vomiting.||1.21|0.593|0.356
71669582|NCT00707239|142856464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0054||||0.836|TWO_SIDED|95.0|0.956|1.06|||Regression, Logistic|||Statistical analysis was carried out between categories, cure and failure/indeterminate.||1.06|0.956|0.836
71669583|NCT00707239|142856468|SUPERIORITY_OR_OTHER|||||||0.245|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Intravenous antibiotic treatment: One-way analysis of variance (ANOVA) with treatment as factor was used to calculate p-value.||||0.245
71669584|NCT00707239|142856468|SUPERIORITY_OR_OTHER|||||||0.484|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||Hospital stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.484
71753489|NCT02587221|143009649|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the vaccine strains.~An ILI was defined as the presence of ≥1 respiratory symptom (eg. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|49.94|||||TWO_SIDED|95.0|-24.03|79.79|||Regression, Cox|Adjusted for covariates||The efficacy of aQIV would be demonstrated if the LL of the two-sided multiplicity adjusted 95%CI for the vaccine efficacy is \>40%||79.79|-24.03|
71753490|NCT02587221|143009650|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|61.5|||||TWO_SIDED|95.0|-7.98|86.28|||Regression, Cox|Adjusted for covariates||||86.28|-7.98|
71669585|NCT00707239|142856468|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED|||||Statistical testing was done at 5% alpha.|ANOVA|||ICU stay: One-way ANOVA with treatment as factor was used to calculate p-value.||||0.192
71669586|NCT01651117|142856471|EQUIVALENCE|Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.|Mean Difference (Final Values)|-0.3268|STANDARD_ERROR_OF_MEAN|0.1739||0.0611|TWO_SIDED|95.0|-0.669|0.0154||Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).|Mixed Models Analysis|Multiple imputation used for intent-to-treat analysis.|Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.|||0.0154|-0.6690|0.0611
71669587|NCT02714218|142856501|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0144|TWO_SIDED|95.0|0.38|0.9|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.90|0.38|0.0144
71669588|NCT02714218|142856501|SUPERIORITY||Estimated Difference of rates|-12.7|||||TWO_SIDED|95.0|-22.7|-2.6|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-2.6|-22.7|
71669589|NCT02714218|142856502|SUPERIORITY||Odds Ratio (OR)|0.55||||0.0059|TWO_SIDED|95.0|0.36|0.84|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3||||0.84|0.36|0.0059
71669590|NCT02714218|142856502|SUPERIORITY||Estimated Difference of rates|-14.4|||||TWO_SIDED|95.0|-24.5|-4.3|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS|||-4.3|-24.5|
71785999|NCT01059825|143070093|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62||||0|TWO_SIDED|80.0|-0.82|-0.42||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.42|-0.82|0.000
71786000|NCT01059825|143070093|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.72||||0|TWO_SIDED|80.0|-0.93|-0.52||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.||-0.52|-0.93|0.000
71786001|NCT01059825|143070093|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0|TWO_SIDED|80.0|-0.97|-0.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-0.97|0.000
71786002|NCT01059825|143070094|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.13||||0.049|TWO_SIDED|80.0|-0.24|-0.03||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.03|-0.24|0.049
71786003|NCT01059825|143070094|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.29||||0|TWO_SIDED|80.0|-0.39|-0.18||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.18|-0.39|0.000
71669591|NCT02714218|142856503|SUPERIORITY||Odds Ratio (OR)|0.8||||0.2923|TWO_SIDED|95.0|0.53|1.21|||Cochran-Mantel-Haenszel||p-value from CMH Test for the comparison of the odds ratio of N3I1 over N1I3|||1.21|0.53|0.2923
71786004|NCT01059825|143070094|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.22||||0.004|TWO_SIDED|80.0|-0.32|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.32|0.004
71786005|NCT01059825|143070094|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.17||||0.02|TWO_SIDED|80.0|-0.27|-0.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.06|-0.27|0.020
71786006|NCT01059825|143070094|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.25||||0.001|TWO_SIDED|80.0|-0.36|-0.15||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.15|-0.36|0.001
71669592|NCT02714218|142856504|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.79|1.47|||||Hazard Ratio is N3I1 over N1I3. (NIVO 3 + IPI 1 (N3I1) over NIVO 1 + IPI 3 (N1I3))|||1.47|0.79|
71669593|NCT02714218|142856505|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4512|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||||1.48|0.84|0.4512
71669594|NCT00663793|142856565|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05|||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon sign-rank|||||||<0.05
71669595|NCT00663793|142856566|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study.|||||<|0.05||95.0|||||Wilcoxon sign-rank|||||||<0.05
71669596|NCT00663793|142856567|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was performed for this pilot study||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Area-under-the-curve for serum estradiol||||0.05
71669597|NCT01400477|142856594|SUPERIORITY|||||||0.89||||||A priori vape was \<0.05|ANOVA|df 1, 37||||||0.89
71753491|NCT02587221|143009651|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any vaccine strain regardless of antigenic match.~An ILI was defined as the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|28.66|||||TWO_SIDED|95.0|0.05|49.08|||Regression, Cox|Adjusted for covariates||||49.08|0.05|
71753492|NCT02587221|143009652|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|33.47|||||TWO_SIDED|95.0|2.56|54.57|||Regression, Cox|Adjusted for covariates||||54.57|2.56|
71753493|NCT02587221|143009653|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the vaccine strains.~An ILI is the presence of ≥1 respiratory symptom (e.g. sore throat, cough, sputum production, wheezing, or difficulty breathing) concurrently with ≥1 systemic symptom (temp \>37.2°C/99°F, chills, tiredness, headache, or myalgia) (protocol defined ILI definition)."|Vaccine efficacy (VE)|23.79|||||TWO_SIDED|95.0|-9.69|47.05|||Regression, Cox|Adjusted for covariates||||47.05|-9.69|
71753494|NCT02587221|143009654|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature \>37.2°C) with cough or sore throat (modified CDC ILI definition)."|Vaccine efficacy (VE)|26.11|||||TWO_SIDED|95.0|-11.71|51.13|||Regression, Cox|Adjusted for covariates||||51.13|-11.71|
71753495|NCT02587221|143009659|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of RT-PCR confirmed due to any strain.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|51.08|||||TWO_SIDED|95.0|28.21|66.67|||Regression, Cox|Adjusted for covariates||||66.67|28.21|
71753496|NCT02587221|143009660|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically matched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)"|Vaccine efficacy (VE)|74.96|||||TWO_SIDED|95.0|-17.93|94.68|||Regression, Cox|Adjusted for covariates||||94.68|-17.93|
71753497|NCT02587221|143009661|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza regardless of antigenic match.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|60.17|||||TWO_SIDED|95.0|31.19|76.94|||Regression, Cox|Adjusted for covariates||||76.94|31.19|
71753498|NCT02587221|143009662|OTHER|"VE=1-HR, where HR is the hazard ratio estimated by the Cox proportional hazards model for time to first occurrence of culture confirmed influenza due to any strain of influenza antigenically unmatched to the strains selected for the seasonal vaccine.~An ILI was defined as presence of fever (temperature ≥38°C) with cough (WHO ILI definition)."|Vaccine efficacy (VE)|57.02|||||TWO_SIDED|95.0|22.73|76.09|||Regression, Cox|Adjusted for covariates||||76.09|22.73|
71753499|NCT01791244|143009719|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.9148|TWO_SIDED|95.0|-8.3|9.25|||linear mixed model|||Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.||9.25|-8.30|0.9148
71753500|NCT02893293|143009850|OTHER|||||||0.002||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.002
71753501|NCT02893293|143009851|OTHER|||||||0.02||||||A p-value less than the a priori threshold of 0.05 was considered statistically significant.|Mixed Models Analysis|Mixed effects model including a random effect term accounting for correlation among the measures with a same patient.||||||0.02
71753502|NCT02960217|143009882|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|1.46||||0.2684|TWO_SIDED|95.0|-1.12|4.36||Hodges-Lehmann estimate of the location shift with 95% confidence interval (CI) and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Participants completing both UX007 treatment period and placebo period (n=42). Per protocol, when the normality assumption is not met (p value for Wilk-Shapiro test \< 0.05), Wilcoxon rank-sum test will be considered as the primary analysis to assess treatment difference in movement disorder event frequency.||4.36|-1.12|0.2684
71753503|NCT02960217|143009882|SUPERIORITY||||||<|0.0001|||||||Wilk-Shapiro test for normality|||||||< 0.0001
71786007|NCT01059825|143070095|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0|TWO_SIDED|80.0|-0.5|-0.23||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-0.50|0.000
71753504|NCT02960217|143009885|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|25.0||||0.6419|TWO_SIDED|95.0|-62.5|91.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=34).||91.5|-62.5|0.6419
71753505|NCT02960217|143009885|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
71753506|NCT02960217|143009886|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.9513|TWO_SIDED|95.0|-2.0|1.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.9|-2.0|0.9513
71753507|NCT02960217|143009886|SUPERIORITY|||||||0.8214|||||||Wilk-Shapiro Test for Normality|||||||0.8214
71753508|NCT02960217|143009887|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.32||0.1572|TWO_SIDED|95.0|-0.8|4.7||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.7|-0.8|0.1572
71753509|NCT02960217|143009887|SUPERIORITY|||||||0.8451|||||||Wilk-Shapiro Test for Normality|||||||0.8451
71669598|NCT04052620|142856637|NON_INFERIORITY|Non-inferiority criteria: if the upper 95% Confidence Interval (CI) of Least Square (LS) mean difference was less than 13 mm then DDEA 2.32% gel BID was concluded as non-inferior.|Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|2.09||0.595|TWO_SIDED|95.0|-3.0|5.22|||ANCOVA|||||5.22|-3.00|0.5950
71669599|NCT04052620|142856639|OTHER||Mean Difference (Final Values)|-2.43|STANDARD_ERROR_OF_MEAN|2.12||0.2536|TWO_SIDED|95.0|-6.61|1.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||1.75|-6.61|0.2536
71669600|NCT04052620|142856639|OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|1.76||0.6643|TWO_SIDED|95.0|-4.23|2.7|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||2.70|-4.23|0.6643
71669601|NCT04052620|142856640|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.19||0.3118|TWO_SIDED|95.0|-1.13|3.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.54|-1.13|0.3118
71669602|NCT04052620|142856640|OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|1.35||0.4937|TWO_SIDED|95.0|-3.6|1.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.74|-3.60|0.4937
71669603|NCT04052620|142856640|OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.67||0.3825|TWO_SIDED|95.0|-1.83|4.74|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.74|-1.83|0.3825
71669604|NCT04052620|142856641|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.26||0.836|TWO_SIDED|95.0|-2.23|2.75|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||2.75|-2.23|0.8360
71669605|NCT04052620|142856641|OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.24||0.3119|TWO_SIDED|95.0|-3.69|1.18|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||1.18|-3.69|0.3119
71669606|NCT04052620|142856641|OTHER||Mean Difference (Final Values)|1.66|STANDARD_ERROR_OF_MEAN|1.45||0.2535|TWO_SIDED|95.0|-1.2|4.52|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||4.52|-1.20|0.2535
71669607|NCT04052620|142856642|OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.51||0.6242|TWO_SIDED|95.0|-2.23|3.71|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||3.71|-2.23|0.6242
71669608|NCT04052620|142856642|OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|2.06||0.8905|TWO_SIDED|95.0|-4.33|3.77|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.77|-4.33|0.8905
71786008|NCT01059825|143070095|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.45||||0|TWO_SIDED|80.0|-0.59|-0.32||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.32|-0.59|0.000
71669609|NCT04052620|142856642|OTHER||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|2.24||0.3439|TWO_SIDED|95.0|-2.29|6.54|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||6.54|-2.29|0.3439
71669610|NCT04052620|142856643|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1554|TWO_SIDED|95.0|-0.44|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.44|0.1554
71669611|NCT04052620|142856643|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0047|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||-0.12|-0.66|0.0047
71669612|NCT04052620|142856643|OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.10|-0.66|0.0082
71669613|NCT04052620|142856644|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2182|TWO_SIDED|95.0|-0.3|0.07|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 3|||0.07|-0.30|0.2182
71786009|NCT01059825|143070095|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
71669614|NCT04052620|142856644|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.0574|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.01|-0.36|0.0574
71669615|NCT04052620|142856644|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.0194|TWO_SIDED|95.0|-0.37|-0.03|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 8|||-0.03|-0.37|0.0194
71669616|NCT04052620|142856645|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.821||0.6545|TWO_SIDED|95.0|-1.25|1.986|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.986|-1.250|0.6545
71669617|NCT04052620|142856645|OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.721||0.4924|TWO_SIDED|95.0|-1.915|0.924|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||0.924|-1.915|0.4924
71669618|NCT04052620|142856646|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.823||0.9491|TWO_SIDED|95.0|-1.675|1.57|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 1|||1.570|-1.675|0.9491
71669619|NCT04052620|142856646|OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.451||0.582|TWO_SIDED|95.0|-2.059|3.659|||ANCOVA||DDEA 2.32% gel vs DDEA 1.16% gel, Day 5|||3.659|-2.059|0.5820
71669620|NCT00473590|142856688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956||||0.9179|TWO_SIDED|95.0|0.404|2.261|||Log Rank|The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratios were estimated using Cox regression.|Stratified analysis||2.261|0.404|0.9179
71669621|NCT00473590|142856688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.6665|TWO_SIDED|95.0|0.369|1.893||The tests were exploratory because patients were not randomized to the two arms with respect to response status.|Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis.||1.893|0.369|0.6665
71669622|NCT00473590|142856689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.633||||0.3134|TWO_SIDED|95.0|0.258|1.552|||Log Rank||The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|Stratified analysis||1.552|0.258|0.3134
71669623|NCT00473590|142856689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2634|TWO_SIDED|95.0|0.251|1.468|||Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis||1.468|0.251|0.2634
71669624|NCT00473590|142856690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743||||0.2804|TWO_SIDED|95.0|0.432|1.276|||Log Rank|The analysis was stratified for number of prior cancer treatments (1, \> 1) and β2-microglobulin level (\< 3.5, ≥ 3.5 mg/L).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.||1.276|0.432|0.2804
71669625|NCT00473590|142856690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.713||||0.2009|TWO_SIDED|95.0|0.424|1.2|||Log Rank||Hazard ratio relative to BORT + P was estimated using Cox regression.|Unstratified Analysis.||1.200|0.424|0.2009
71669626|NCT01112059|142856700|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.05|TWO_SIDED|95.0|0.128|0.633|||Wilcoxon (Mann-Whitney)|||||0.633|0.128|<0.05
71669627|NCT00395161|142856703|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Log Rank|Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)||Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).||||0.29
71669628|NCT00395161|142856704|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Rate analysis (see comments)|95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.||Null hypothesis of equal event rates in the two study arms.||||0.81
71669629|NCT00395161|142856705|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
71669630|NCT00395161|142856706|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Chi-squared|||||||0.07
71753510|NCT02960217|143009888|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.66||0.8345|TWO_SIDED|95.0|-3.8|3.1||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.1|-3.8|0.8345
71753511|NCT02960217|143009888|SUPERIORITY|||||||0.2894|||||||Wilk-Shapiro Test for Normality|||||||0.2894
71753512|NCT02960217|143009889|SUPERIORITY|||||||0.0005|||||||Wilk-Shapiro Test for Normality|||||||0.0005
71753513|NCT02960217|143009889|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.2||||0.4898|TWO_SIDED|95.0|-5.4|5.8||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=21).||5.8|-5.4|0.4898
71786010|NCT01059825|143070095|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.36||||0|TWO_SIDED|80.0|-0.49|-0.22||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.22|-0.49|0.000
71786011|NCT01059825|143070095|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.44||||0|TWO_SIDED|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.57|0.000
71786012|NCT01059825|143070096|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.47||||0|TWO_SIDED|80.0|-0.64|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-0.64|0.000
71669631|NCT00395161|142856707|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Chi-squared|||||||0.16
71753514|NCT02960217|143009890|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.42||0.5853|TWO_SIDED|95.0|-2.2|3.8||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||3.8|-2.2|0.5853
71753515|NCT02960217|143009890|SUPERIORITY|||||||0.1066|||||||Wilk-Shapiro Test for Normality|||||||0.1066
71786013|NCT01059825|143070096|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.66||||0|TWO_SIDED|80.0|-0.83|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.49|-0.83|0.000
71669632|NCT04199104|142856710|SUPERIORITY||point estimate|19.3||||1.9e-06|TWO_SIDED|95.0|11.2|27.3|||Miettinen and Nurminen method|||||27.3|11.2|0.0000019
71669633|NCT04199104|142856711|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0001129|TWO_SIDED|95.0|0.55|0.83|||Regression, Cox|||||0.83|0.55|0.0001129
71669634|NCT04199104|142856712|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.8819584|TWO_SIDED|95.0|0.91|1.45|||Regression, Cox|||||1.45|0.91|0.8819584
71669635|NCT05258773|142856743|SUPERIORITY||LS Mean difference Arm A - Arm B|-11.0||||0.1406|TWO_SIDED|95.0|-25.9|3.9||An analysis of covariance (ANCOVA) model was used to assess changes from baseline at 500Hz at the Day 49 visit comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||3.9|-25.9|0.1406
71677162|NCT03557931|142872904|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|1.54||0.721|TWO_SIDED|90.0|-3.11|2.01|||ANCOVA|||ANCOVA model is performed with change from baseline (LS Mean estimate for observed value from separate model using observed values) at the Week 12 timepoint as response, treatment and site (pooled where necessary) and baseline as a covariate.||2.01|-3.11|0.721
71677163|NCT00737204|142872906|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||ANCOVA|||||||<0.001
71753516|NCT02960217|143009891|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.33||0.1875|TWO_SIDED|95.0|-4.6|1.0||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||1.0|-4.6|0.1875
71753517|NCT02960217|143009891|SUPERIORITY|||||||0.2034|||||||Wilk-Shapiro Test for Normality|||||||0.2034
71753518|NCT02960217|143009892|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.56||0.1138|TWO_SIDED|95.0|-0.7|5.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.9|-0.7|0.1138
71753519|NCT02960217|143009892|SUPERIORITY|||||||0.1478|||||||Wilk-Shapiro Test for Normality|||||||0.1478
71753520|NCT02960217|143009893|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.62||0.5505|TWO_SIDED|95.0|-4.6|2.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||2.6|-4.6|0.5505
71753521|NCT02960217|143009893|SUPERIORITY|||||||0.4459|||||||Wilk-Shapiro Test for Normality|||||||0.4459
71669636|NCT05258773|142856743|SUPERIORITY||LS Mean difference Arm A - Arm B|-14.4||||0.0567|TWO_SIDED|95.0|-29.24|0.45||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at the Day 49 visit comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||0.45|-29.24|0.0567
71669637|NCT05258773|142856743|SUPERIORITY||LS Mean difference Arm A - Arm B|-9.0||||0.2588|TWO_SIDED|95.0|-25.0|7.1||An ANCOVA model was used to assess changes from baseline at 500Hz at EOS on Day 105 comparing the treatment groups.The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||7.1|-25.0|0.2588
71669638|NCT05258773|142856743|SUPERIORITY||LS Mean difference Arm A - Arm B|-13.84||||0.0979|TWO_SIDED|95.0|-30.49|2.8||An ANCOVA model was used to assess changes from baseline at the average across three frequencies (250-750 Hz) at EOS on Day 105, comparing the treatment groups. The treatment group was included as a fixed factor, with baseline values as a covariate.|ANCOVA||The change in hearing threshold from baseline was expected to be smaller in the treated group (arm A) than in the control group (arm B).|||2.80|-30.49|0.0979
71669639|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|0.9999|||||TWO_SIDED|95.0|0.8313|1.2025||||||||1.2025|0.8313|
71669640|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.2454|||||TWO_SIDED|95.0|1.0355|1.4979||||||||1.4979|1.0355|
71786014|NCT01059825|143070096|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.63||||0|TWO_SIDED|80.0|-0.8|-0.45||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.45|-0.80|0.000
71786015|NCT01059825|143070096|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.65||||0|TWO_SIDED|80.0|-0.82|-0.47||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.47|-0.82|0.000
71669641|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.2392|||||TWO_SIDED|95.0|1.0304|1.4904||||||||1.4904|1.0304|
71669642|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.2394|||||TWO_SIDED|95.0|1.0305|1.4906||||||||1.4906|1.0305|
71669643|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|0.995|||||TWO_SIDED|95.0|0.8273|1.1967||||||||1.1967|0.8273|
71669644|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.5058|||||TWO_SIDED|95.0|1.252|1.811||||||||1.8110|1.2520|
71669645|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.506|||||TWO_SIDED|95.0|1.2522|1.8113||||||||1.8113|1.2522|
71669646|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.2091|||||TWO_SIDED|95.0|1.0053|1.4541||||||||1.4541|1.0053|
71669647|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.2151|||||TWO_SIDED|95.0|1.0103|1.4614||||||||1.4614|1.0103|
71669648|NCT05277922|142856745|SUPERIORITY||Geometric mean ratio|1.2456|||||TWO_SIDED|95.0|1.0357|1.4981||||||||1.4981|1.0357|
71786016|NCT01059825|143070096|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.67||||0|TWO_SIDED|80.0|-0.84|-0.5||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.50|-0.84|0.000
71786017|NCT01059825|143070098|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.15||||0.007|TWO_SIDED|80.0|-1.75|-0.55||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.75|0.007
71836493|NCT04391894|143178936|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.3|0.1||||||||0.1|-0.3|
71836494|NCT04391894|143178936|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.1|0.6||||||||0.6|0.1|
71836495|NCT03526874|143178938|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
71669649|NCT06700512|142856765|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|paired||"H0 (Objective 1) SRT (study HA) is either not significantly different from SRT without HAs or significantly worse than SRT without HAs.~H1(Objective 1) SRT(study HA) is significantly better than SRT without HAs. A mean difference in SRT of 1 dB measured with the Oldenburg sentence test can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement."||||<0.001
71669650|NCT06700512|142856765|NON_INFERIORITY|A mean difference in SRT of 1 dB measured with the Oldenburg sentence test (Wagener et al, 1999a-c), can be assumed as a typical difference in speech intelligibility to show a clinically meaningful improvement (Kollmeier et al, 2011). Thus if SRT with study hearing aids is 1dB or more worse than with subjects' own hearing aids and the difference is significant (p\<0.05), inferiority of study hearing aid is assumed otherwise study hearing aids are considered non-inferior|||||<|0.001||||||paired|t-test, 1 sided|||H0 (Objective 2) SRT (study HA) is significantly worse than SRT(own HAs). H1(Objective 2) There is no difference between SRT(study HA) and SRT(own HAs) or SRT (study HA) is significantly better than SRT (own HAs) SRT= Speech Reception Threshold in dB||||<0.001
71669651|NCT01415518|142856797|SUPERIORITY_OR_OTHER||Ratio|1.069|||<|0.0001|TWO_SIDED|95.0|1.043|1.096|||ANCOVA|multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.096|1.043|<.0001
71669652|NCT01415518|142856798|SUPERIORITY_OR_OTHER||Ratio|1.067|||<|0.0001|TWO_SIDED|95.0|1.044|1.09|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.090|1.044|<.0001
71669653|NCT01415518|142856799|SUPERIORITY_OR_OTHER||Ratio|1.068|||<|0.0001||95.0|1.043|1.092|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.092|1.043|<.0001
71669654|NCT01415518|142856800|SUPERIORITY_OR_OTHER||Ratio|1.04||||0.0007|TWO_SIDED|95.0|1.017|1.064|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.064|1.017|0.0007
71669655|NCT01415518|142856801|SUPERIORITY_OR_OTHER||Ratio|1.045|||<|0.0001|TWO_SIDED|95.0|1.024|1.065|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.065|1.024|<.0001
71669656|NCT01415518|142856802|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0003|TWO_SIDED|95.0|1.017|1.06|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.060|1.017|0.0003
71891882|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.1|-0.2|
71891883|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.2|-0.1|
71891884|NCT03193866|143305376|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.3|-0.1|
71891885|NCT03193866|143305377|SUPERIORITY||Difference in proportion|4.8|||||TWO_SIDED|95.0|-2.2|11.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||11.9|-2.2|
71891886|NCT03193866|143305377|SUPERIORITY||Difference in proportion|9.0|||||TWO_SIDED|95.0|-2.6|20.6||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||20.6|-2.6|
71669657|NCT01415518|142856803|SUPERIORITY_OR_OTHER||Ratio|1.035||||0.0248|TWO_SIDED|95.0|1.004|1.066|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.066|1.004|0.0248
71677164|NCT00737204|142872907|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||ANCOVA|||Repeated measure analysis||||.01
71786018|NCT01059825|143070098|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.75||||0|TWO_SIDED|80.0|-2.35|-1.14||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.14|-2.35|0.000
71786019|NCT01059825|143070098|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.15||||0|TWO_SIDED|80.0|-2.76|-1.54||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.54|-2.76|0.000
71786020|NCT01059825|143070098|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.91||||0|TWO_SIDED|80.0|-2.52|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.52|0.000
71786021|NCT01059825|143070098|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.833|TWO_SIDED|80.0|-0.15|1.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.06|-0.15|0.833
71786022|NCT01059825|143070099|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.42||||0.043|TWO_SIDED|80.0|-0.73|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-0.73|0.043
71786023|NCT01059825|143070099|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.13||||0|TWO_SIDED|80.0|-1.44|-0.81||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.81|-1.44|0.000
71786024|NCT01059825|143070099|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.9||||0|TWO_SIDED|80.0|-1.22|-0.59||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-1.22|0.000
71786025|NCT01059825|143070099|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.87||||0|TWO_SIDED|80.0|-1.18|-0.55||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.55|-1.18|0.000
71786026|NCT01059825|143070099|SUPERIORITY_OR_OTHER||Difference in least squares means|0.45||||0.967|TWO_SIDED|80.0|0.14|0.76||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.76|0.14|0.967
71786027|NCT01059825|143070100|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.008|TWO_SIDED|80.0|-1.17|-0.36||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.36|-1.17|0.008
71786028|NCT01059825|143070100|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.32||||0|TWO_SIDED|80.0|-1.73|-0.91||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.91|-1.73|0.000
71786029|NCT01059825|143070100|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24||||0|TWO_SIDED|80.0|-1.65|-0.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.83|-1.65|0.000
71669658|NCT01415518|142856804|SUPERIORITY_OR_OTHER||Ratio|1.038||||0.0074|TWO_SIDED|95.0|1.01|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate||||1.067|1.010|0.0074
71753522|NCT02960217|143009894|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.84||0.5544|TWO_SIDED|95.0|-8.1|4.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.6|-8.1|0.5544
71753523|NCT02960217|143009894|SUPERIORITY|||||||0.1104|||||||Wilk-Shapiro Test for Normality|||||||0.1104
71669659|NCT01415518|142856805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.172||||0.0001|TWO_SIDED|95.0|12.733|37.611|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||37.611|12.733|0.0001
71669660|NCT01415518|142856806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.136|||<|0.0001|TWO_SIDED|95.0|12.163|30.11|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||30.110|12.163|<.0001
71753524|NCT02960217|143009895|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|3.27||0.7145|TWO_SIDED|95.0|-8.5|6.1|||ANCOVA|||||6.1|-8.5|0.7145
71753525|NCT02960217|143009895|SUPERIORITY|||||||0.8255|||||||Wilk-Shapiro Test for Normality|||||||0.8255
71753526|NCT02960217|143009896|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.82||0.4176|TWO_SIDED|95.0|-2.5|5.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||5.6|-2.5|0.4176
71753527|NCT02960217|143009896|SUPERIORITY|||||||0.6557|||||||Wilk-Shapiro Test for Normality|||||||0.6557
71753528|NCT02960217|143009897|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.09||0.0935|TWO_SIDED|95.0|-0.4|4.5||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA|||||4.5|-0.4|0.0935
71753529|NCT02960217|143009897|SUPERIORITY|||||||0.7267|||||||Wilk-Shapiro Test for Normality|||||||0.7267
71753530|NCT02960217|143009898|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8329|TWO_SIDED|95.0|-0.6|0.5||Based on an ANCOVA model including covariate for study baseline CGI-S score, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||0.5|-0.6|0.8329
71753531|NCT02960217|143009898|SUPERIORITY|||||||0.2348|||||||Wilk-Shapiro Test for Normality|||||||0.2348
71753532|NCT02960217|143009900|SUPERIORITY|||||||0.0315|||||||Wilk-Shapiro Test for Normality|||||||0.0315
71753533|NCT02960217|143009900|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|-0.5||||0.2425|TWO_SIDED|95.0|-1.5|0.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||0.5|-1.5|0.2425
71753534|NCT02960217|143009901|SUPERIORITY|||||||0.0072|||||||Wilk-Shapiro Test for Normality|||||||0.0072
71753535|NCT02960217|143009901|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|0.0||||1|TWO_SIDED|95.0|-14.5|13.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=12).||13.5|-14.5|1.0000
71753536|NCT02960217|143009902|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.54||0.1076|TWO_SIDED|95.0|-0.3|2.2||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.2|-0.3|0.1076
71753537|NCT02960217|143009902|SUPERIORITY|||||||0.7698|||||||Wilk-Shapiro Test for Normality|||||||0.7698
71753538|NCT02960217|143009903|SUPERIORITY|||||||0.0138|||||||Wilk-Shapiro Test for Normality|||||||0.0138
71753539|NCT02960217|143009903|SUPERIORITY||Hodges-Lehmann estimate (Median Diff.)|2.0||||0.3907|TWO_SIDED|95.0|-3.5|20.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).||20.5|-3.5|0.3907
71753540|NCT02960217|143009904|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.5233|TWO_SIDED|95.0|-4.4|2.4||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA|||||2.4|-4.4|0.5233
71753541|NCT02960217|143009904|SUPERIORITY|||||||0.6918|||||||Wilk-Shapiro Test for Normality|||||||0.6918
71753542|NCT00214045|143009905|SUPERIORITY_OR_OTHER|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||.39
71753543|NCT00214045|143009905|NON_INFERIORITY_OR_EQUIVALENCE|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
71753544|NCT01743469|143009910|SUPERIORITY_OR_OTHER|||||||0.142||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.142
71753545|NCT01743469|143009910|SUPERIORITY_OR_OTHER|||||||1||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>35%).||||1.000
71753546|NCT01743469|143009910|SUPERIORITY_OR_OTHER|||||||0.8||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>20%).||||0.800
71753547|NCT01743469|143009910|SUPERIORITY_OR_OTHER|||||||0.63||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (\>15%).||||0.630
71753548|NCT01743469|143009911|SUPERIORITY_OR_OTHER|||||||0.5||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with a prespecified threshold (\>20%).||||0.500
71836496|NCT03526874|143178939|SUPERIORITY|||||||0.031|||||||t-test, 2 sided|||||||0.031
71836497|NCT03526874|143178940|SUPERIORITY|||||||0.0162|||||||ANOVA|Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0162
71836498|NCT03526874|143178941|SUPERIORITY|||||||0.04||||||Two-way Anova to test sex interaction with treatment effect. The study was not powered for subgroup analyses.|ANOVA|||||||0.04
71669661|NCT01415518|142856807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.044|||<|0.0001|TWO_SIDED|95.0|14.927|31.161|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||31.161|14.927|<.0001
71753549|NCT01446159|143009950|SUPERIORITY||Hazard Ratio (HR)|0.991||||0.86|TWO_SIDED|95.0|0.689|1.429|||Log Rank|||||1.429|0.689|0.86
71753550|NCT00795535|143009979|SUPERIORITY_OR_OTHER||||||<|0.15|TWO_SIDED|||||To avoid overfitting the models, only predictors with p\<0.15 were included in the final models.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.||||< 0.15
71753551|NCT01766050|143009981|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
71753552|NCT01766050|143009981|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
71753553|NCT01766050|143009981|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
71753554|NCT01766050|143009999|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.976|1.13||||||AUC (0-T)||1.130|0.976|
71753555|NCT01766050|143009999|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.966|||||TWO_SIDED|90.0|0.889|1.049||||||AUC (0-T)||1.049|0.889|
71753556|NCT01766050|143009999|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.033|||||TWO_SIDED|90.0|0.95|1.123||||||AUC (0-T)||1.123|0.950|
71753557|NCT01766050|143009999|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.049|||||TWO_SIDED|90.0|0.975|1.127||||||AUC (INF)||1.127|0.975|
71753558|NCT01766050|143009999|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.968|||||TWO_SIDED|90.0|0.892|1.049||||||AUC (INF)||1.049|0.892|
71786030|NCT01059825|143070100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.08||||0|TWO_SIDED|80.0|-1.49|-0.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward..||||-0.67|-1.49|0.000
71786031|NCT01059825|143070100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.922|TWO_SIDED|80.0|0.04|0.86||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.86|0.04|0.922
71786032|NCT01059825|143070101|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.03||||0.003|TWO_SIDED|80.0|-1.51|-0.56||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.56|-1.51|0.003
71786033|NCT01059825|143070101|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.57||||0|TWO_SIDED|80.0|-2.04|-1.09||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.09|-2.04|0.000
71786034|NCT01059825|143070101|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.68||||0|TWO_SIDED|80.0|-2.16|-1.21||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.21|-2.16|0.000
71669662|NCT01415518|142856808|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.513|||<|0.0001|TWO_SIDED|95.0|18.74|44.286|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||44.286|18.740|<.0001
71669663|NCT01415518|142856809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.322|||<|0.0001|TWO_SIDED|95.0|14.425|34.22|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||34.220|14.425|<.0001
71753559|NCT01766050|143009999|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.948|1.121||||||AUC(INF)||1.121|0.948|
71753560|NCT01766050|143010000|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.991|||||TWO_SIDED|90.0|0.898|1.093||||||||1.093|0.898|
71753561|NCT01766050|143010000|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.911|||||TWO_SIDED|90.0|0.83|1.0||||||||1.000|0.830|
71753562|NCT01766050|143010000|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.994|||||TWO_SIDED|90.0|0.885|1.116||||||||1.116|0.885|
71753563|NCT01766050|143010001|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.013|||||TWO_SIDED|90.0|0.944|1.088||||||AUC (0-T)||1.088|0.944|
71753564|NCT01766050|143010001|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.936|1.103||||||AUC (0-T)||1.103|0.936|
71753565|NCT01766050|143010001|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.001|||||TWO_SIDED|90.0|0.893|1.121||||||AUC (0-T)||1.121|0.893|
71753566|NCT01766050|143010001|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.011|||||TWO_SIDED|90.0|0.942|1.085||||||AUC (INF)||1.085|0.942|
71753567|NCT01766050|143010001|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.016|||||TWO_SIDED|90.0|0.938|1.101||||||AUC (INF)||1.101|0.938|
71753568|NCT01766050|143010001|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.896|1.121||||||AUC (INF)||1.121|0.896|
71753569|NCT01766050|143010002|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.26|||||TWO_SIDED|90.0|1.118|1.421||||||||1.421|1.118|
71753570|NCT01766050|143010002|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.292|||||TWO_SIDED|90.0|1.09|1.531||||||||1.531|1.090|
71753571|NCT01766050|143010002|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.178|||||TWO_SIDED|90.0|0.971|1.429||||||||1.429|0.971|
71753572|NCT01766050|143010003|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.159|||||TWO_SIDED|90.0|1.056|1.272||||||AUC (0-T)||1.272|1.056|
71753573|NCT01766050|143010003|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.228|||||TWO_SIDED|90.0|1.092|1.381||||||AUC (0-T)||1.381|1.092|
71753574|NCT01766050|143010003|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.215|||||TWO_SIDED|90.0|1.047|1.41||||||AUC (0-T)||1.410|1.047|
71753575|NCT01766050|143010003|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.193|||||TWO_SIDED|90.0|1.091|1.304||||||AUC (INF)||1.304|1.091|
71669664|NCT01415518|142856810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.168|||<|0.0001|TWO_SIDED|95.0|18.906|35.431|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate||||35.431|18.906|<.0001
71669665|NCT01415518|142856811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.297||||0.0102|TWO_SIDED|95.0|-0.522|-0.071|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.071|-0.522|0.0102
71669666|NCT01415518|142856812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.343||||0.0004|TWO_SIDED|95.0|-0.533|-0.153|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.153|-0.533|0.0004
71669667|NCT01415518|142856813|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.342||||0.0002|TWO_SIDED|95.0|-0.523|-0.162|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.162|-0.523|0.0002
71669668|NCT01415518|142856814|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.279|||<|0.0001|TWO_SIDED|95.0|-0.381|-0.177|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.177|-0.381|<.0001
71669669|NCT01415518|142856815|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.193||||0.0002|TWO_SIDED|95.0|-0.294|-0.092|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.092|-0.294|0.0002
71669670|NCT01415518|142856816|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.208||||0.0001|TWO_SIDED|95.0|-0.308|-0.108|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate||||-0.108|-0.308|0.0001
71669671|NCT01415518|142856817|SUPERIORITY_OR_OTHER||Rate ratio|0.565||||0.0425|TWO_SIDED|95.0|0.325|0.981|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable||||0.981|0.325|0.0425
71753576|NCT01766050|143010003|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.227|||||TWO_SIDED|90.0|1.093|1.379||||||AUC (INF)||1.379|1.093|
71786035|NCT01059825|143070101|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.78||||0|TWO_SIDED|80.0|-2.26|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.30|-2.26|0.000
71669672|NCT01415518|142856817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.604||||0.088|TWO_SIDED|95.0|0.339|1.078|||Regression, Cox|Time to the first COPD exacerbation||||1.078|0.339|0.0880
71669673|NCT01415518|142856817|SUPERIORITY_OR_OTHER|||||||0.0845|||||||Log Rank|Time to the first COPD exacerbation||||||0.0845
71669674|NCT01415518|142856818|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.055||||0.2281|TWO_SIDED|95.0|-0.144|0.035|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||0.035|-0.144|0.2281
71669675|NCT01415518|142856819|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.122||||0.001|TWO_SIDED|95.0|-0.194|-0.049|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.049|-0.194|0.0010
71669676|NCT01415518|142856820|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.106||||0.0073|TWO_SIDED|95.0|-0.183|-0.029|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate||||-0.029|-0.183|0.0073
71669677|NCT01730053|142856829|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.2|||<|0.0001|TWO_SIDED|98.75|-49.2|-19.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.||-19.3|-49.2|<0.0001
71669678|NCT01730053|142856829|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-36.1|||<|0.0001|TWO_SIDED|98.75|-51.5|-20.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||-20.7|-51.5|<0.0001
71669679|NCT01730053|142856829|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||=|0.0453|TWO_SIDED|98.75|-45.8|5.1||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||5.1|-45.8|=0.0453
71669680|NCT01730053|142856829|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-25.3|||=|0.0136|TWO_SIDED|98.75|-50.9|0.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.||0.3|-50.9|=0.0136
71669681|NCT01730053|142856830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-23.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1.25 % level.||-23.0|-47.4|<0.0001
71753577|NCT01766050|143010003|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.3|||||TWO_SIDED|90.0|1.141|1.482||||||AUC (INF)||1.482|1.141|
71753578|NCT01766050|143010004|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.746|0.997||||||||0.997|0.746|
71753579|NCT01766050|143010004|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.793|1.071||||||||1.071|0.793|
71753580|NCT01766050|143010004|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.856|||||TWO_SIDED|90.0|0.709|1.034||||||||1.034|0.709|
71753581|NCT01766050|143010005|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.915|||||TWO_SIDED|90.0|0.817|1.024||||||AUC (0-T)||1.024|0.817|
71753582|NCT01766050|143010005|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.003|||||TWO_SIDED|90.0|0.856|1.175||||||AUC (0-T)||1.175|0.856|
71753583|NCT01766050|143010005|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.963|||||TWO_SIDED|90.0|0.821|1.13||||||AUC (0-T)||1.130|0.821|
71753584|NCT01766050|143010005|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.877|||||TWO_SIDED|90.0|0.783|0.982||||||AUC (INF)||0.982|0.783|
71786036|NCT01059825|143070101|SUPERIORITY_OR_OTHER||Difference in least squares means|0.24||||0.741|TWO_SIDED|80.0|-0.24|0.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.71|-0.24|0.741
71669682|NCT01730053|142856830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|98.75|-45.9|-20.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-20.5|-45.9|<0.0001
71677165|NCT00737204|142872908|SUPERIORITY_OR_OTHER||||||>=|0.805||95.0|||||Paired t-tests|||Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.||||>=.805
71669683|NCT01730053|142856830|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.5|||=|0.0131|TWO_SIDED|98.75|-49.2|0.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||0.2|-49.2|=0.0131
71669684|NCT01730053|142856831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|98.75|-47.4|-17.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-17.9|-47.4|<0.0001
71753585|NCT01766050|143010005|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.031|||||TWO_SIDED|90.0|0.885|1.2||||||AUC (INF)||1.200|0.885|
71753586|NCT01766050|143010005|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.022|||||TWO_SIDED|90.0|0.839|1.245||||||AUC (INF)||1.245|0.839|
71753587|NCT01766050|143010006|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.948|||||TWO_SIDED|90.0|0.88|1.021||||||||1.021|0.880|
71753588|NCT01766050|143010006|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.922|||||TWO_SIDED|90.0|0.857|0.993||||||||0.993|0.857|
71753589|NCT01766050|143010006|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.954|||||TWO_SIDED|90.0|0.885|1.028||||||||1.028|0.885|
71753590|NCT01766050|143010007|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.941|||||TWO_SIDED|90.0|0.874|1.013||||||AUC (0-T)||1.013|0.874|
71753591|NCT01766050|143010007|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.986|||||TWO_SIDED|90.0|0.902|1.076||||||AUC (0-T)||1.076|0.902|
71753592|NCT01766050|143010007|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.027|||||TWO_SIDED|90.0|0.942|1.12||||||AUC (0-T)||1.120|0.942|
71753593|NCT01766050|143010007|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.939|||||TWO_SIDED|90.0|0.868|1.017||||||AUC (INF)||1.017|0.868|
71786037|NCT01059825|143070103|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.13||||0.163|TWO_SIDED|80.0|-4.92|0.65||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.65|-4.92|0.163
71786038|NCT01059825|143070103|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.48||||0.056|TWO_SIDED|80.0|-6.28|-0.68||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.68|-6.28|0.056
71786039|NCT01059825|143070103|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.88||||0.096|TWO_SIDED|80.0|-5.7|-0.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.05|-5.70|0.096
71836499|NCT03526874|143178942|SUPERIORITY|||||||0.0098|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0098
71836500|NCT03526874|143178943|SUPERIORITY|||||||0.02|||||||ANOVA|Two-way Anova to test ethnicity interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.02
71753594|NCT01766050|143010007|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.002|||||TWO_SIDED|90.0|0.914|1.098||||||||1.098|0.914|
71753595|NCT01766050|143010007|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.036|||||TWO_SIDED|90.0|0.94|1.142||||||AUC (INF)||1.142|0.940|
71753596|NCT02535481|143010087|SUPERIORITY|||||||0.366||||||At 6 weeks|Fisher Exact|||||||0.366
71753597|NCT02535481|143010087|SUPERIORITY|||||||0.24||||||At 3 months|Fisher Exact|||||||0.24
71753598|NCT02535481|143010088|SUPERIORITY||||||<|0.0001|||||||Log Rank|Kaplan-Meier analysis of cumulative wound healing followed by a log rank test||||||<0.0001
71753599|NCT02535481|143010089|SUPERIORITY|||||||0.12|||||||Log Rank|||||||0.12
71753600|NCT02535481|143010090|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71753601|NCT02535481|143010091|SUPERIORITY|||||||0.001||||||At 6 weeks|Wilcoxon (Mann-Whitney)|||||||0.001
71753602|NCT02535481|143010091|SUPERIORITY|||||||0.001||||||At 3 months|Wilcoxon (Mann-Whitney)|||||||0.001
71753603|NCT02764385|143010093|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.01||||||||2.01|1.73|
71753604|NCT02764385|143010093|SUPERIORITY||Odds Ratio (OR)|0.68||||0.05|TWO_SIDED|95.0|0.45|1.02|||Regression, Logistic|We adjust for clustering of visit within clinician and clinical site and the stepped wedge study design using generalized estimating equation methods.||||1.02|.45|.05
71753605|NCT02764385|143010094|SUPERIORITY||Odds Ratio (OR)|1.87|||||TWO_SIDED|95.0|1.73|2.1||||||||2.10|1.73|
71753606|NCT04607668|143010099|OTHER||Mean Difference (Final Values)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.7|-0.6||Two-sided p-value for treatment effect was generated from a nonparametric ANCOVA controlling for stratification factors of Region and Prior chemotherapy with study baseline ANC value as a covariate.|ANCOVA|||||-0.6|-1.7|<0.001
71753607|NCT04607668|143010100|OTHER||aRR|0.04|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.01|0.19|||modified Poisson model|||||0.19|0.01|<0.001
71753608|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.16||||0.0029|TWO_SIDED|95.0|0.06|0.26||estimates of total lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2600|0.0600|0.0029
71753609|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.1825||||0.0007|TWO_SIDED|95.0|0.0855|0.2795||estimates of left lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2795|0.0855|0.0007
71753610|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.1565||||0.0093|TWO_SIDED|95.0|0.0419|0.2711||estimates of right lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2711|0.0419|0.0093
71786040|NCT01059825|143070103|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.37||||0.064|TWO_SIDED|80.0|-6.21|-0.53||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.53|-6.21|0.064
71786041|NCT01059825|143070103|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.54||||0.403|TWO_SIDED|80.0|-3.33|2.26||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.26|-3.33|0.403
71836501|NCT03526874|143178944|SUPERIORITY|||||||0.01|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.01
71669685|NCT01730053|142856831|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.2|||<|0.0001|TWO_SIDED|98.75|-47.0|-17.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.5|-47|<0.0001
71753611|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.1764||||0.0007|TWO_SIDED|95.0|0.0823|0.2704||estimates of left lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2704|0.0823|0.0007
71669686|NCT01730053|142856832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|98.75|-48.2|-22.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.5|-48.2|<0.0001
71753612|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.1999||||0.001|TWO_SIDED|95.0|0.0894|0.3103||estimates of left lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3103|0.0894|0.0010
71669687|NCT01730053|142856832|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|98.75|-45.6|-19.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-19.0|-45.6|<0.0001
71786042|NCT01059825|143070104|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.425|TWO_SIDED|80.0|-2.91|2.17||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.17|-2.91|0.425
71786043|NCT01059825|143070104|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.81||||0.082|TWO_SIDED|80.0|-5.38|-0.23||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.23|-5.38|0.082
71786044|NCT01059825|143070104|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.35||||0.43|TWO_SIDED|80.0|-2.92|2.21||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.21|-2.92|0.430
71786045|NCT01059825|143070104|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.47||||0.043|TWO_SIDED|80.0|-6.05|-0.89||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.89|-6.05|0.043
71786046|NCT01059825|143070104|SUPERIORITY_OR_OTHER||Difference in least squares means|1.01||||0.694|TWO_SIDED|80.0|-1.55|3.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.58|-1.55|0.694
71786047|NCT01059825|143070105|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38||||0.234|TWO_SIDED|80.0|-3.81|1.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.05|-3.81|0.234
71786048|NCT01059825|143070105|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.59||||0.087|TWO_SIDED|80.0|-5.03|-0.14||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.14|-5.03|0.087
71786049|NCT01059825|143070105|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.86||||0.068|TWO_SIDED|80.0|-5.33|-0.4||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.40|-5.33|0.068
71786050|NCT01059825|143070105|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.77||||0.346|TWO_SIDED|80.0|-3.25|1.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.71|-3.25|0.346
71786051|NCT01059825|143070105|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76||||0.346|TWO_SIDED|80.0|-3.21|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-3.21|0.346
71786052|NCT01059825|143070106|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.1||||0.306|TWO_SIDED|80.0|-3.87|1.67||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.67|-3.87|0.306
71786053|NCT01059825|143070106|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.41||||0.133|TWO_SIDED|80.0|-5.19|0.37||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.37|-5.19|0.133
71786054|NCT01059825|143070106|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.61||||0.117|TWO_SIDED|80.0|-5.42|0.2||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.20|-5.42|0.117
71786055|NCT01059825|143070106|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.87||||0.097|TWO_SIDED|80.0|-5.69|-0.04||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.04|-5.69|0.097
71786056|NCT01059825|143070106|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.0||||0.179|TWO_SIDED|80.0|-4.78|0.79||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.79|-4.78|0.179
71786057|NCT01059825|143070108|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.93||||0.072|TWO_SIDED|80.0|-3.62|-0.24||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.24|-3.62|0.072
71786058|NCT01059825|143070108|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.81||||0.086|TWO_SIDED|80.0|-3.51|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.11|-3.51|0.086
71786059|NCT01059825|143070108|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.99||||0.002|TWO_SIDED|80.0|-5.71|-2.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-2.27|-5.71|0.002
71786060|NCT01059825|143070108|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.025|TWO_SIDED|80.0|-4.37|-0.92||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.92|-4.37|0.025
71836502|NCT03526874|143178945|SUPERIORITY|||||||0.0329|||||||ANOVA|Two-way Anova to test race interaction with treatment effect. The study was not powered for subgroup analyses.||||||0.0329
71836503|NCT03526874|143178946|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||||||0.294
71836504|NCT03526874|143178947|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
71669688|NCT01730053|142856833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.2|||<|0.0001|TWO_SIDED|98.75|-40.1|-18.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.3|-40.1|<0.0001
71669689|NCT01730053|142856833|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-26.8|||<|0.0001|TWO_SIDED|98.75|-37.9|-15.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-15.7|-37.9|<0.0001
71669690|NCT01730053|142856834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.7|||<|0.0001|TWO_SIDED|98.75|-40.1|-21.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-21.3|-40.1|<0.0001
71669691|NCT01730053|142856834|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|98.75|-38.0|-18.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-18.7|-38.0|<0.0001
71669692|NCT01730053|142856835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-31.4|||<|0.0001|TWO_SIDED|98.75|-43.9|-18.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-18.9|-43.9|<0.0001
71836505|NCT03526874|143178948|SUPERIORITY|||||||0.182|||||||t-test, 2 sided|||||||0.182
71669693|NCT01730053|142856835|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.3|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-16.4|-42.1|<0.0001
71669694|NCT01730053|142856836|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-32.8|||<|0.0001|TWO_SIDED|98.75|-43.2|-22.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-22.4|-43.2|<0.0001
71669695|NCT01730053|142856836|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|98.75|-39.1|-17.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-17.3|-39.1|<0.0001
71669696|NCT01730053|142856837|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6|||<|0.0001|TWO_SIDED|98.75|-29.4|-11.8||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-11.8|-29.4|<0.0001
71669697|NCT01730053|142856837|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.3|||<|0.0001|TWO_SIDED|98.75|-29.3|-11.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-11.2|-29.3|<0.0001
71669698|NCT01730053|142856838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.1|||<|0.0001|TWO_SIDED|98.75|-39.7|-16.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.5|-39.7|<0.0001
71669699|NCT01730053|142856838|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.0|||<|0.0001|TWO_SIDED|98.75|-35.7|-12.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.3|-35.7|<0.0001
71669700|NCT01730053|142856839|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-29.5|||<|0.0001|TWO_SIDED|98.75|-42.1|-16.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-16.9|-42.1|<0.0001
71669701|NCT01730053|142856839|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|98.75|-37.7|-12.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-12.2|-37.7|<0.0001
71836506|NCT03526874|143178949|SUPERIORITY|||||||0.423|||||||Fisher Exact|||||||0.423
71836507|NCT03526874|143178950|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.030
71836508|NCT03526874|143178951|SUPERIORITY|||||||0.112|||||||Fisher Exact|||||||0.112
71836509|NCT03526874|143178952|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
71836510|NCT03526874|143178953|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
71836511|NCT04285567|143178980|SUPERIORITY||Difference in Rates|26.6||||0.0004|TWO_SIDED|95.0|12.33|40.87|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.||40.87|12.33|0.0004
71836512|NCT04285567|143178982|SUPERIORITY||Difference in Rates|20.78||||0.0053|TWO_SIDED|95.0|6.66|34.9|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||34.90|6.66|0.0053
71836513|NCT04285567|143178983|SUPERIORITY||Difference in Rates|31.63|||<|0.0001|TWO_SIDED|95.0|16.55|46.71|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||46.71|16.55|< .0001
71836514|NCT04285567|143178984|SUPERIORITY||Difference in Response Rates|9.68||||0.1119|TWO_SIDED|95.0|-2.05|21.41|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||21.41|-2.05|0.1119
71836515|NCT04285567|143178985|SUPERIORITY||Difference in Response Rates|17.44||||0.0154|TWO_SIDED|95.0|1.96|32.93|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||32.93|1.96|0.0154
71891887|NCT03193866|143305377|SUPERIORITY||Difference in proportion|-0.7|||||TWO_SIDED|95.0|-7.6|6.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.2|-7.6|
71786061|NCT01059825|143070108|SUPERIORITY_OR_OTHER||Difference in least squares means|0.88||||0.746|TWO_SIDED|80.0|-0.82|2.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||2.58|-0.82|0.746
71786062|NCT01059825|143070109|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.69||||0.289|TWO_SIDED|80.0|-2.27|0.9||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.90|-2.27|0.289
71786063|NCT01059825|143070109|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.288|TWO_SIDED|80.0|-2.31|0.91||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.91|-2.31|0.288
71786064|NCT01059825|143070109|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.41||||0.13|TWO_SIDED|80.0|-3.01|0.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.19|-3.01|0.130
71786065|NCT01059825|143070109|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.44||||0.026|TWO_SIDED|80.0|-4.05|-0.84||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.84|-4.05|0.026
71786066|NCT01059825|143070109|SUPERIORITY_OR_OTHER||Difference in least squares means|1.49||||0.883|TWO_SIDED|80.0|-0.11|3.08||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||3.08|-0.11|0.883
71786067|NCT01059825|143070110|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.67||||0.063|TWO_SIDED|80.0|-3.07|-0.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.27|-3.07|0.063
71786068|NCT01059825|143070110|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.29||||0.019|TWO_SIDED|80.0|-3.69|-0.88||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.88|-3.69|0.019
71786069|NCT01059825|143070110|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.035|TWO_SIDED|80.0|-3.43|-0.59||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.59|-3.43|0.035
71786070|NCT01059825|143070110|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.3||||0.121|TWO_SIDED|80.0|-2.73|0.12||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.12|-2.73|0.121
71786071|NCT01059825|143070110|SUPERIORITY_OR_OTHER||Difference in least squares means|0.29||||0.602|TWO_SIDED|80.0|-1.13|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.70|-1.13|0.602
71786072|NCT01059825|143070111|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.2||||0.045|TWO_SIDED|80.0|-3.86|-0.54||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.54|-3.86|0.045
71786073|NCT01059825|143070111|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.49||||0.126|TWO_SIDED|80.0|-3.16|0.18||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||0.18|-3.16|0.126
71786074|NCT01059825|143070111|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.03||||0.011|TWO_SIDED|80.0|-4.72|-1.34||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-1.34|-4.72|0.011
71786075|NCT01059825|143070111|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.99||||0.066|TWO_SIDED|80.0|-3.69|-0.3||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-0.30|-3.69|0.066
71786076|NCT01059825|143070111|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.357|TWO_SIDED|80.0|-2.15|1.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||1.19|-2.15|0.357
71786077|NCT01059825|143070113|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.99||||0|TWO_SIDED|80.0|-28.29|-13.69||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.69|-28.29|0.000
71786078|NCT01059825|143070113|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.82||||0|TWO_SIDED|80.0|-33.17|-18.47||P-value is one-sided.P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-18.47|-33.17|0.000
71786079|NCT01059825|143070113|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.23||||0|TWO_SIDED|80.0|-41.64|-26.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-26.83|-41.64|0.000
71786080|NCT01059825|143070113|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.02||||0|TWO_SIDED|80.0|-39.49|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.49|0.000
71786081|NCT01059825|143070113|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.05||||0|TWO_SIDED|80.0|-27.39|-12.72||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.72|-27.39|0.000
71786082|NCT01059825|143070114|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.96||||0|TWO_SIDED|80.0|-28.58|-13.34||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.34|-28.58|0.000
71669702|NCT01730053|142856840|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.1|||<|0.0001|TWO_SIDED|98.75|-29.4|-10.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).||-10.7|-29.4|<0.0001
71836516|NCT04285567|143178986|SUPERIORITY||Difference in Rates|18.93||||0.0054|TWO_SIDED|95.0|0.91|36.95|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||36.95|0.91|0.0054
71836517|NCT04285567|143178987|SUPERIORITY||Difference in Rates|26.79||||0.0038|TWO_SIDED|95.0|3.86|49.72|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||49.72|3.86|0.0038
71669703|NCT01730053|142856840|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.2|||<|0.0001|TWO_SIDED|98.75|-26.7|-7.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.||-7.7|-26.7|<0.0001
71669704|NCT01730053|142856841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.4|||<|0.0001|TWO_SIDED|98.75|2.6|59.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||59.5|2.6|<0.0001
71669705|NCT01730053|142856841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||=|0.0007|TWO_SIDED|98.75|1.8|40.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||40.5|1.8|=0.0007
71786083|NCT01059825|143070114|SUPERIORITY_OR_OTHER||Difference in least squares means|-21.57||||0|TWO_SIDED|80.0|-29.27|-13.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-13.86|-29.27|0.000
71786084|NCT01059825|143070114|SUPERIORITY_OR_OTHER||Difference in least squares means|-32.54||||0|TWO_SIDED|80.0|-40.2|-24.88||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.88|-40.20|0.000
71786085|NCT01059825|143070114|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.33||||0|TWO_SIDED|80.0|-30.05|-14.61||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-14.61|-30.05|0.000
71786086|NCT01059825|143070114|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.57||||0|TWO_SIDED|80.0|-28.19|-12.96||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-12.96|-28.19|0.000
71786087|NCT01059825|143070115|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.09||||0|TWO_SIDED|80.0|-29.16|-15.01||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.01|-29.16|0.000
71786088|NCT01059825|143070115|SUPERIORITY_OR_OTHER||Difference in least squares means|-27.94||||0|TWO_SIDED|80.0|-35.06|-20.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-20.83|-35.06|0.000
71786089|NCT01059825|143070115|SUPERIORITY_OR_OTHER||Difference in least squares means|-33.12||||0|TWO_SIDED|80.0|-40.29|-25.95||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-25.95|-40.29|0.000
71786090|NCT01059825|143070115|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.79||||0|TWO_SIDED|80.0|-39.02|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-24.56|-39.02|0.000
71786091|NCT01059825|143070115|SUPERIORITY_OR_OTHER||Difference in least squares means|-23.17||||0|TWO_SIDED|80.0|-30.28|-16.07||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-16.07|-30.28|0.000
71786092|NCT01059825|143070116|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.07||||0|TWO_SIDED|80.0|-28.87|-15.27||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.27|-28.87|0.000
71786093|NCT01059825|143070116|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.51||||0|TWO_SIDED|80.0|-35.35|-21.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-21.67|-35.35|0.000
71786094|NCT01059825|143070116|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.4||||0|TWO_SIDED|80.0|-42.3|-28.51||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-28.51|-42.30|0.000
71786095|NCT01059825|143070116|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-41.76|-27.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-27.86|-41.76|0.000
71786096|NCT01059825|143070116|SUPERIORITY_OR_OTHER||Difference in least squares means|-22.75||||0|TWO_SIDED|80.0|-29.58|-15.92||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p \<0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||||-15.92|-29.58|0.000
71786097|NCT05620563|143070146|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.28|0.87|||||Posterior mean difference with 95% credible interval is reported.|||0.87|-0.28|
71753613|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.136||||0.0159|TWO_SIDED|95.0|0.0276|0.2443||estimates of right lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2443|0.0276|0.0159
71753614|NCT02135861|143010141|OTHER||Mean Difference (Final Values)|0.1748||||0.0064|TWO_SIDED|95.0|0.0535|0.2961||estimates of right lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2961|0.0535|0.0064
71753615|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|-0.0137||||0.7381|TWO_SIDED|95.0|-0.0968|0.0695||estimates of total lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0695|-0.0968|0.7381
71786098|NCT05620563|143070147|SUPERIORITY||Posterior Mean Difference|-0.15|||||TWO_SIDED|95.0|-1.13|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-1.13|
71786099|NCT05620563|143070148|SUPERIORITY||Posterior Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.99|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.99|
71786100|NCT05620563|143070149|SUPERIORITY||Posterior Mean Difference|-0.55|||||TWO_SIDED|95.0|-3.82|2.69|||||Posterior mean difference with 95% credible interval is reported.|||2.69|-3.82|
71786101|NCT05620563|143070150|SUPERIORITY||Posterior Mean Difference|0.09|||||TWO_SIDED|95.0|-0.33|0.51|||||Posterior mean difference with 95% credible interval is reported.|||0.51|-0.33|
71786102|NCT05620563|143070151|SUPERIORITY||Posterior Mean Difference|0.3|||||TWO_SIDED|95.0|-0.35|0.95|||||Posterior mean difference with 95% credible interval is reported.|||0.95|-0.35|
71786103|NCT05620563|143070152|SUPERIORITY||Posterior Mean Difference|2.2|||||TWO_SIDED|95.0|-5.7|9.99|||||Posterior mean difference with 95% credible interval is reported.|||9.99|-5.70|
71786104|NCT05620563|143070153|SUPERIORITY||Posterior Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.39|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.39|
71786105|NCT05620563|143070154|SUPERIORITY||Posterior Mean Difference|24.16|||||TWO_SIDED|95.0|-115.48|166.06|||||Posterior mean difference with 95% credible interval is reported.|||166.06|-115.48|
71786106|NCT05620563|143070155|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.09|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.09|
71786107|NCT00869206|143070156|NON_INFERIORITY_OR_EQUIVALENCE|Based on the published data on the effect of a standard of dosing schedule of \> zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0|||||<=|0.05|||||||Cochran-Mantel-Haenszel|||||||<=.05
71786108|NCT00869206|143070157|SUPERIORITY_OR_OTHER||Slope|-0.00394|STANDARD_ERROR_OF_MEAN|0.00962||0.68|TWO_SIDED||||||Mixed Models Analysis|Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status||||||0.68
71786109|NCT00869206|143070158|SUPERIORITY_OR_OTHER||Slope|0.0016|STANDARD_ERROR_OF_MEAN|0.0034||0.64|TWO_SIDED||||||Mixed Models Analysis|Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status||||||0.64
71786110|NCT00869206|143070160|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.1|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.10
71786111|NCT00411645|143070174|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.902||||0.789|TWO_SIDED|95.0|0.424|1.92||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|||1.920|0.424|0.789
71753616|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|0.0136||||0.6992|TWO_SIDED|95.0|-0.058|0.0852||estimates of left lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0852|-0.0580|0.6992
71786112|NCT00411645|143070175|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.721||||0.056|TWO_SIDED|95.0|0.515|1.008||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||1.008|0.515|0.056
71786113|NCT00411645|143070175|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.979||||0.904|TWO_SIDED|95.0|0.697|1.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.375|0.697|0.904
71786114|NCT00411645|143070175|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.838||||0.289|TWO_SIDED|95.0|0.606|1.161||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia or CMV DNA PCR assay||1.161|0.606|0.289
71786115|NCT00411645|143070175|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.891||||0.493|TWO_SIDED|95.0|0.64|1.239||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.239|0.640|0.493
71786116|NCT00411645|143070176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129|TWO_SIDED||||||Log Rank|||||||0.129
71786117|NCT00411645|143070176|SUPERIORITY_OR_OTHER_LEGACY||Adjusted hazard ratio|0.83||||0.13|TWO_SIDED|95.0|0.65|1.06||The p-value from Wald Chi-Square test for treatment effect.|Wald Chi-squared||Maribavir versus placebo; based on Cox's proportional hazards regression model: time = recipient CMV serostatus (R+ or R-) + transplant type (myeloablative or non-myeloablative/reduced intensity) + treatment.|||1.06|0.65|0.130
71836518|NCT04285567|143178989|SUPERIORITY||Difference in Response Rates|3.05||||0.4199|TWO_SIDED|95.0|-5.73|11.84|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|P-value estimated using CMH test stratified by the IvRS randomization stratification factors.||11.84|-5.73|0.4199
71836519|NCT04986501|143179003|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
71836520|NCT04986501|143179005|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
71891888|NCT03193866|143305377|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-9.4|4.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.1|-9.4|
71669706|NCT01730053|142856842|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|98.75|2.58|88.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||88.2|2.58|<0.0001
71836521|NCT03964350|143179008|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71836522|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MontgomeryÅsberg Depression Rating Scale (MADRS) ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0105|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0105
71836523|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.03||0.0134|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.03|-0.14|0.0134
71836524|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3495|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3495
71836525|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.7008|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex right||0.04|-0.07|0.7008
71836526|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6635|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.05|-0.08|0.6635
71836527|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8792|TWO_SIDED|90.0|-0.09|0.07|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.07|-0.09|0.8792
71836528|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0419|TWO_SIDED|90.0|-0.15|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.02|-0.15|0.0419
71836529|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1658|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.01|-0.12|0.1658
71836530|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6673|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % change/ Amygdala Left||0.05|-0.08|0.6673
71669707|NCT01730053|142856842|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.9|||=|0.001|TWO_SIDED|98.75|1.7|56.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||56.7|1.7|=0.001
71836531|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0778|TWO_SIDED|90.0|-0.14|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD Signal % Change/ Amygdala Right||-0.01|-0.14|0.0778
71836532|NCT03854578|143179010|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3258|TWO_SIDED|90.0|-0.08|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.08|0.3258
71836533|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5954|TWO_SIDED|90.0|-0.07|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.04|-0.07|0.5954
71669708|NCT01730053|142856843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.6|||<|0.0001|TWO_SIDED|98.75|3.6|96.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||96.2|3.6|<0.0001
71786118|NCT00411645|143070177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.542|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.542
71786119|NCT00411645|143070177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.637
71786120|NCT00411645|143070177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.825|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 12 months post-transplant||||0.825
71786121|NCT00411645|143070178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.669||||0.022|TWO_SIDED|95.0|0.474|0.946||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay||0.946|0.474|0.022
71786122|NCT00411645|143070178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.878||||0.468|TWO_SIDED|95.0|0.617|1.247||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay||1.247|0.617|0.468
71786123|NCT00411645|143070178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.772||||0.125|TWO_SIDED|95.0|0.555|1.075||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay or CMV DNA PCR assay||1.075|0.555|0.125
71786124|NCT00411645|143070178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.731||||0.069|TWO_SIDED|95.0|0.521|1.026||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy||1.026|0.521|0.069
71786125|NCT00411645|143070178|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.913||||0.86|TWO_SIDED|95.0|0.332|2.508||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of EC-confirmed disease||2.508|0.332|0.860
71786126|NCT00411645|143070179|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.835||||0.617|TWO_SIDED|95.0|0.411|1.693||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 12 months post-transplant||1.693|0.411|0.617
71786127|NCT00411645|143070180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.7808|TWO_SIDED|95.0|0.754|1.457||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||1.457|0.754|0.7808
71786128|NCT00411645|143070180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.068||||0.6946|TWO_SIDED|95.0|0.771|1.479||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.479|0.771|0.6946
71786129|NCT00411645|143070181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.186||||0.6304|TWO_SIDED|95.0|0.592|2.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant||2.375|0.592|0.6304
71836534|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5911|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.04|-0.08|0.5911
71836535|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8283|TWO_SIDED|90.0|-0.11|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.08|-0.11|0.8283
71753617|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|-0.0258||||0.5778|TWO_SIDED|95.0|-0.1201|0.0684||estimates of right lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0684|-0.1201|0.5778
71753618|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|0.0005||||0.9899|TWO_SIDED|95.0|-0.0738|0.0747||estimates of left lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0747|-0.0738|0.9899
71753619|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|0.0396||||0.2912|TWO_SIDED|95.0|-0.036|0.1153||estimates of left lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1153|-0.0360|0.2912
71753620|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|-0.0362||||0.4592|TWO_SIDED|95.0|-0.1355|0.0631||estimates of right lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0631|-0.1355|0.4592
71753621|NCT02135861|143010142|OTHER||Mean Difference (Final Values)|-0.0118||||0.7936|TWO_SIDED|95.0|-0.1036|0.08||estimates of right lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0800|-0.1036|0.7936
71753622|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1148||||0.0156|TWO_SIDED|95.0|0.0236|0.2061||estimates of total lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2061|0.0236|0.0156
71753623|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1366||||0.0026|TWO_SIDED|95.0|0.0523|0.2209||estimates of left lung- Pre-exercise|ANOVA|estimates of left lung- Pre-exercise|||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2209|0.0523|0.0026
71753624|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1067||||0.0328|TWO_SIDED|95.0|0.0094|0.204||estimates of right lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2040|0.0094|0.0328
71753625|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1145||||0.0158|TWO_SIDED|95.0|0.0235|0.2056||estimates of left lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2056|0.0235|0.0158
71753626|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1776||||0.0002|TWO_SIDED|95.0|0.0917|0.2635||estimates of left lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2635|0.0917|0.0002
71753627|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.0956||||0.0658|TWO_SIDED|95.0|-0.0067|0.1979||estimates of right lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.1979|-0.0067|0.0658
71753628|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1194||||0.015|TWO_SIDED|95.0|0.0251|0.2137||estimates of right lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2137|0.0251|0.0150
71786130|NCT00411645|143070181|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.726||||0.1019|TWO_SIDED|95.0|0.495|1.066||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant||1.066|0.495|0.1019
71786131|NCT04626297|143070185|OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|90.0|-10.2|11.2||||||||11.2|-10.2|
71786132|NCT04626297|143070186|OTHER||Risk Difference (RD)|12.2|||||TWO_SIDED|90.0|2.5|22.0||||||||22.0|2.5|
71786133|NCT04626297|143070187|OTHER||Risk Difference (RD)|21.7|||<|0.001|TWO_SIDED|95.0|10.3|33.2|||Cochran-Mantel-Haenszel|||||33.2|10.3|<0.001
71786134|NCT04626297|143070188|OTHER||Risk Difference (RD)|25.3|||<|0.001|TWO_SIDED|95.0|12.6|38.0|||Cochran-Mantel-Haenszel|||||38|12.6|<0.001
71786135|NCT04626297|143070189|OTHER||Risk Difference (RD)|20.3|||<|0.001|TWO_SIDED|95.0|9.0|31.6|||Cochran-Mantel-Haenszel|||||31.6|9.0|<0.001
71786136|NCT04626297|143070190|OTHER||Risk Difference (RD)|11.9||||0.138|TWO_SIDED|95.0|-3.8|27.5|||Cochran-Mantel-Haenszel|||||27.5|-3.8|0.138
71786137|NCT04626297|143070191|OTHER||LS Mean Difference|-8.21|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-13.04|-3.39|||Mixed Models Analysis||The mixed model repeated measures (MMRM) included treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, geographic region, age group, baseline IGA score as fixed factors.|||-3.39|-13.04|<0.001
71786138|NCT04626297|143070192|OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.152||0.001658|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001658
71786139|NCT01425281|143070195|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm \[258 lesions\] vs Xience arm \[130 lesions\]).||||0.49
71753629|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1428||||0.0015|TWO_SIDED|95.0|0.0598|0.2259||estimates of total lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2259|0.0598|0.0015
71786140|NCT01425281|143070196|NON_INFERIORITY|Using t-test with non-inferiority margin of 0.140mm||||||0.78|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.||||0.78
71786141|NCT03250845|143070301|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%||||<0.0001
71786142|NCT03250845|143070302|SUPERIORITY||||||<|0.0005|||||||t-test, 1 sided|||H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%||||<0.0005
71786143|NCT03250845|143070304|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion||||0.03
71786144|NCT03167411|143070311|EQUIVALENCE|The ratio of the least squares (LS) geometric means of Cmax when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|125.27|||||TWO_SIDED|90.0|104.45|150.24|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||150.24|104.45|
71786145|NCT03167411|143070314|EQUIVALENCE|The ratio of the least squares (LS) geometric means of AUC0-inf when bexagliflozin is dosed in combination with exenatide versus when dosed alone, with 80-125% defined as the lack of interaction boundaries. 90% confidence intervals was constructed.|Point Estimate (%)|137.56|||||TWO_SIDED|90.0|122.28|154.75|||||Estimated ratio (%) of exponentiated mean difference of log-transformed PK parameter from ANOVA (linear mixed-effects model), with treatment, period, and sequence as fixed effects, and subject as a random effect.|||154.75|122.28|
71786146|NCT02602496|143070316|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9942||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9942
71786147|NCT02602496|143070316|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0062|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0062
71786148|NCT02602496|143070316|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6843|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6843
71786149|NCT02602496|143070317|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.5096||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.5096
71786150|NCT02602496|143070317|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2276|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2276
71786151|NCT02602496|143070317|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0006|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0006
71786152|NCT02602496|143070318|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9708||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9708
71786153|NCT02602496|143070318|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.1642|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.1642
71786154|NCT02602496|143070318|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.6043|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.6043
71786155|NCT02602496|143070319|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0868||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.0868
71786156|NCT02602496|143070319|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0083|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0083
71786157|NCT02602496|143070319|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0151|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0151
71786158|NCT02602496|143070320|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.9255||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.9255
71786159|NCT02602496|143070320|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.0454|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.0454
71786160|NCT02602496|143070320|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.292|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.2920
71786161|NCT02602496|143070321|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.2252||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.2252
71786162|NCT02602496|143070321|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.4715|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.4715
71786163|NCT02602496|143070321|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.7157|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.7157
71786164|NCT02602496|143070322|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8323||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA|||||||0.8323
71786165|NCT02602496|143070322|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.8927|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.8927
71786166|NCT02602496|143070322|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.3173|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index||||||0.3173
71786167|NCT02602496|143070323|EQUIVALENCE|Value at week 8 minus value at week 0||||||0.27||||||Corrected for baseline concentrations, age and gender|ANOVA|||||||0.27
71786168|NCT04294472|143070349|SUPERIORITY|Cohort 1 vs Placebo||||||0.1866|||||||Log Rank|||||||0.1866
71786169|NCT04294472|143070349|SUPERIORITY|Cohort 2 vs Placebo||||||0.2627|||||||Log Rank|||||||0.2627
71786170|NCT04294472|143070350|SUPERIORITY|Cohort 1 vs Placebo||||||0.0639|||||||Log Rank|||||||0.0639
71786171|NCT04294472|143070350|SUPERIORITY|Cohort 2 vs Placebo||||||0.0508|||||||Log Rank|||||||0.0508
71813116|NCT03720938|143128563|SUPERIORITY|||||||3.67e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.||||0.0000367
71845421|NCT01478594|143205122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915|||||TWO_SIDED|95.0|0.334|2.512|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||2.512|0.334|
71786172|NCT01897402|143070474|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.6|||||TWO_SIDED|95.0|-7.9|9.1|||||Serogroup A|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-7.9|
71786173|NCT01897402|143070474|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-6.0|||||TWO_SIDED|95.0|-14.6|2.6|||||Serogroup C|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||2.6|-14.6|
71786174|NCT01897402|143070474|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-1.0|||||TWO_SIDED|95.0|-9.9|7.9|||||Serogroup Y|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||7.9|-9.9|
71786175|NCT01897402|143070474|NON_INFERIORITY_OR_EQUIVALENCE|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-8.5|9.1|||||Serogroup W-135|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.||9.1|-8.5|
71786176|NCT01482884|143070481|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.8||||0.4062|TWO_SIDED|95.0|-13.0|22.5||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.||22.5|-13.0|0.4062
71786177|NCT01482884|143070482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.3937|TWO_SIDED|95.0|-1.63|0.65|||ANCOVA|Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.||||0.65|-1.63|0.3937
71786178|NCT01482884|143070483|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.1043|TWO_SIDED|95.0|-4.0|28.3||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||28.3|-4.0|0.1043
71786179|NCT01482884|143070484|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.0326|TWO_SIDED|95.0|0.7|24.1||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||||24.1|0.7|0.0326
71786180|NCT01482884|143070486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.33||0.449|TWO_SIDED|95.0|-0.41|0.91|||ANCOVA|Modified Riley score at baseline as a covariate, and treatment as factors in the model.||||0.91|-0.41|0.4490
71786181|NCT05353985|143070492|SUPERIORITY||LS Mean Difference|0.017|||=|0.847|TWO_SIDED|95.0|-0.162|0.197||P-value was based on a MMRM analysis with treatment group, week, treatment-by-week interaction, \& the randomization stratification factors as fixed effects \& baseline CDSD GI symptom severity scores as covariates, and participant as a random effect.|MMRM|||||0.197|-0.162|=0.847
71786182|NCT05353985|143070493|SUPERIORITY||LS Mean Difference|-0.331|||<|0.001|TWO_SIDED|95.0|-0.481|-0.181||P-value was based on a ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline Vh:Cd as covariates.|ANCOVA|||||-0.181|-0.481|<0.001
71786183|NCT00842712|143070555|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.718||||0.0845|TWO_SIDED|95.0|0.492|1.048|||Log Rank|||PFS Time: Independent read||1.048|0.492|0.0845
71786184|NCT00842712|143070556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.5912|TWO_SIDED|95.0|0.642|1.286|||Log Rank|||||1.286|0.642|0.5912
71786185|NCT00842712|143070557|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.813||||0.2648|TWO_SIDED|95.0|0.564|1.171|||Log Rank|||||1.171|0.564|0.2648
71786186|NCT04493281|143070562|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-t for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
71786187|NCT04493281|143070563|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of AUC0-inf for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||||1.04|0.92|
71786188|NCT04493281|143070564|EQUIVALENCE|The analysis was performed by analysis of variance (ANOVA), which included factors accounting for the following sources of variation: sequence, subjects nested in sequences, period, and treatment. For bioequivalence, the 90% CIs of the geometric mean ratio of Cmax for oral suspension and intravenous formulation were required to be within the range of 0.80 to 1.25.|Ratio (PO/IV)|1.22|||||TWO_SIDED|90.0|1.09|1.36||||||||1.36|1.09|
71753630|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1776|||<|0.0001|TWO_SIDED|95.0|0.1057|0.2496||estimates of left lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2496|0.1057|<.0001
71753631|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.126||||0.0114|TWO_SIDED|95.0|0.0308|0.2212||estimates of right lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2212|0.0308|0.0114
71786189|NCT03143894|143070597|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.47|TWO_SIDED||||||t-test, 2 sided|||||||0.47
71786190|NCT03143894|143070598|SUPERIORITY||Mean Difference (Net)|0.69||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
71786191|NCT03143894|143070599|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
71786192|NCT02442869|143070612|SUPERIORITY||Net difference in proportion|1.73||||0.19|TWO_SIDED|95.0|-2.41|15.35|||Chi-squared|Df (1)|NNT = 5.59|Due to the large number of zeroes in the Suicidal Ideation (SI)-Current Subscale of the SSI at post (over a third of the participants reported no SI at the end of treatment), a zero-altered model was utilized which divided the outcome into (1) the probability of any SI and (2) the intensity of SI when non-zero, as done in other studies. This analysis tested the difference between the CAMS and TAU arms based on number of participants reporting no SI post Stage 1 treatment.||15.35|-2.41|0.19
71786193|NCT02442869|143070613|SUPERIORITY||Net difference in proportion|1.3||||0.25|TWO_SIDED||||||Regression, Logistic|||||||0.25
71786194|NCT02442869|143070614|SUPERIORITY|Power analyses. We determined that with a sample size of 62 clients, the outcome analyses had at least 80% power to detect an effect size of 0.80 (Ahn etal., 2001)|Mean Difference (Net)|0.55||||0.035|TWO_SIDED|95.0|0.04|1.05|||t-test, 2 sided|t(60) = 2.15||||1.05|0.04|0.035
71786195|NCT03521934|143070615|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.52|0.85|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.85|0.52|< 0.001
71786196|NCT03521934|143070616|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.49|< 0.001
71786197|NCT03521934|143070617|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.36|TWO_SIDED|95.0|0.58|1.22|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.22|0.58|= 0.36
71786198|NCT03521934|143070618|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.56|0.92||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.92|0.56|
71845422|NCT01478594|143205122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.384|||||TWO_SIDED|95.0|0.554|3.455|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||3.455|0.554|
71753632|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1464||||0.0002|TWO_SIDED|95.0|0.0774|0.2153||estimates of left lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2153|0.0774|0.0002
71669709|NCT01730053|142856843|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.6|||<|0.0001|TWO_SIDED|98.75|2.5|53.1||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||53.1|2.5|<0.0001
71753633|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.2137|||<|0.0001|TWO_SIDED|95.0|0.1266|0.3008||estimates of left lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.3008|0.1266|<.0001
71786199|NCT03521934|143070619|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.86||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.86|0.54|
71786200|NCT03521934|143070620|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.59|1.14||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.14|0.59|
71786201|NCT03521934|143070621|SUPERIORITY||Hazard Ratio (HR)|4.1|||||TWO_SIDED|95.0|1.3|7.0||||||The change from baseline to Month 4 was analyzed using an ANCOVA model with treatment groups as factor and baseline KCCQ-12 score and randomization stratification factors as covariates.||7|1.3|
71786202|NCT03521934|143070622|SUPERIORITY||Difference in Least Squares Means|-0.16|||||TWO_SIDED|95.0|-1.3|0.98||||||Rate of decline in eGFR observed over time was analyzed by MMRM with absolute change in eGFR from baseline as the outcome, a random effect for intercept, and fixed effects for treatment, baseline value, and time.||0.98|-1.3|
71836536|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1797|TWO_SIDED|90.0|-0.12|0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.01|-0.12|0.1797
71836537|NCT03854578|143179010|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.5772|TWO_SIDED|90.0|-0.08|0.04|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.04|-0.08|0.5772
71836538|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0147|TWO_SIDED|90.0|-0.14|-0.03|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||-0.03|-0.14|0.0147
71836539|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.048|TWO_SIDED|90.0|-0.13|-0.01|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||-0.01|-0.13|0.0480
71753634|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1111||||0.025|TWO_SIDED|95.0|0.0151|0.2071||estimates of right lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2071|0.0151|0.0250
71836540|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0294|TWO_SIDED|90.0|-0.12|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||-0.02|-0.12|0.0294
71753635|NCT02135861|143010143|OTHER||Mean Difference (Final Values)|0.1458||||0.0052||95.0|0.0475|0.2442||estimates of right lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.2442|0.0475|0.0052
71786203|NCT05048784|143070623|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for Cmax.|Ratio of geometric least squares means|1.009|||||TWO_SIDED|90.0|0.98|1.04|||||The geometric least squares mean ratios and confidence intervals (Cls) were obtained by taking the exponential of the corresponding differences and Cls on the natural-log (In) scale.|||1.040|0.980|
71845423|NCT01478594|143205123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.538|||||TWO_SIDED|95.0|0.548|4.32|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||4.320|0.548|
71669710|NCT01730053|142856844|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|20.3|||<|0.0001|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||67.7|2.4|<0.0001
71786204|NCT05048784|143070624|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUClast.|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.967|1.055|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.055|0.967|
71845424|NCT01478594|143205123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.744|||||TWO_SIDED|95.0|0.299|1.85|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.|||1.850|0.299|
71845425|NCT03542305|143205142|OTHER||Ratio (%) of Adjusted Geometric Means|104.25|||||TWO_SIDED|90.0|79.73|136.31|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||136.31|79.73|
71845426|NCT03542305|143205142|OTHER||Ratio (%) of Adjusted Geometric Means|118.75|||||TWO_SIDED|90.0|91.43|154.24|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||154.24|91.43|
71845427|NCT03542305|143205142|OTHER||Ratio (%) of Adjusted Geometric Means|141.14|||||TWO_SIDED|90.0|97.82|203.66|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||203.66|97.82|
71786205|NCT05048784|143070625|OTHER|Statistical analysis was conducted to investigate the bioequivalence of treatment A (test 1) to treatment B (reference) for AUCinf.|Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.977|1.065|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.065|0.977|
71786206|NCT05048784|143070627|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for Cmax.|Ratio of geometric least squares means|1.001|||||TWO_SIDED|90.0|0.836|1.199|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.199|0.836|
71753636|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0524||||0.173|TWO_SIDED|95.0|-0.1292|0.0244||estimates of total lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0244|-0.1292|0.1730
71753637|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0423||||0.2704|TWO_SIDED|95.0|-0.1196|0.0349||estimates of left lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0349|-0.1196|0.2704
71753638|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0515||||0.2072|TWO_SIDED|95.0|-0.1334|0.0303||estimates of right lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0303|-0.1334|0.2072
71753639|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0603||||0.1307|TWO_SIDED|95.0|-0.1398|0.0191||estimates of left lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0191|-0.1398|0.1307
71753640|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0078||||0.8427|TWO_SIDED|95.0|-0.0879|0.0722||estimates of left lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0722|-0.0879|0.8427
71786207|NCT05048784|143070628|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUClast.|Ratio of geometric least squares means|1.447|||||TWO_SIDED|90.0|1.2|1.745|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.745|1.200|
71786208|NCT05048784|143070629|OTHER|Statistical analysis was conducted to investigate the food effect of treatment C (test 2) to treatment A (test 1) for AUCinf.|Ratio of geometric least squares means|1.484|||||TWO_SIDED|90.0|1.236|1.783|||||The geometric least squares mean ratios and Cls were obtained by taking the exponential of the corresponding differences and Cls on the In scale.|||1.783|1.236|
71786209|NCT02509156|143070805|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.57||0.746|TWO_SIDED|95.0|-4.52|6.11|||ANCOVA|The change in LVEF was compared using ANCOVA analyses adjusting for baseline values.|Confidence intervals based on t-test|||6.11|-4.52|0.746
71786210|NCT02509156|143070806|SUPERIORITY||slope of time|1.53|STANDARD_ERROR_OF_MEAN|0.63||0.024|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate of the slope of time."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.024
71786211|NCT02509156|143070807|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.94||0.328|TWO_SIDED|95.0|-2.68|1.26|||ANCOVA||Confidence intervals based on t-test|The change in global strain was compared using ANCOVA analyses adjusting for baseline values.||1.26|-2.68|0.328
71669711|NCT01730053|142856844|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.7|||=|0.0002|TWO_SIDED|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.||67.7|2.4|=0.0002
71753641|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0506||||0.1848|TWO_SIDED|95.0|-0.1269|0.0257||estimates of right lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0257|-0.1269|0.1848
71753642|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0413||||0.3408|TWO_SIDED|95.0|-0.1286|0.0461||estimates of right lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0461|-0.1286|0.3408
71753643|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0267||||0.3682|TWO_SIDED|95.0|-0.0866|0.0332||estimates of total lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0332|-0.0866|0.3682
71753644|NCT02135861|143010144|OTHER||Mean Difference (Net)|-0.0201||||0.4531|TWO_SIDED|95.0|-0.0744|0.0342||estimates of left lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0342|-0.0744|0.4531
71786212|NCT02509156|143070808|SUPERIORITY||slope of time|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.261|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.261
71786213|NCT02509156|143070809|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|1.41||0.071|TWO_SIDED|95.0|-4.51|1.35|||ANCOVA||Confidence intervals based on t-test|The change in regional strain was compared using ANCOVA analyses adjusting for baseline values.||1.35|-4.51|0.071
71845428|NCT03542305|143205143|OTHER||Ratio (%) of Adjusted Geometric Means|100.53|||||TWO_SIDED|90.0|66.48|152.02|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Mild renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||152.02|66.48|
71845429|NCT03542305|143205143|OTHER||Slope|88.87|||||TWO_SIDED|90.0|64.18|123.06|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Moderate renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||123.06|64.18|
71753645|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0188||||0.597|TWO_SIDED|95.0|-0.0909|0.0533||estimates of right lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0533|-0.0909|0.5970
71753646|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0159||||0.5472|TWO_SIDED|95.0|-0.0693|0.0375||estimates of left lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0375|-0.0693|0.5472
71753647|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0125||||0.6793|TWO_SIDED|95.0|-0.0742|0.0491||estimates of left lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0491|-0.0742|0.6793
71753648|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0249||||0.4806|TWO_SIDED|95.0|-0.0964|0.0466||estimates of right lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0466|-0.0964|0.4806
71753649|NCT02135861|143010144|OTHER||Mean Difference (Final Values)|-0.0029||||0.9379|TWO_SIDED|95.0|-0.0789|0.0731||estimates of right lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor|0.0731|-0.0789|0.9379
71753650|NCT03186209|143010170|SUPERIORITY||Rate Ratio|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.36||Multiplicity protected by hierarchy testing procedure. First in line hypothesis testing, requiring p-value \<0.05.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||0.36|0.19|<0.0001
71753651|NCT03186209|143010171|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.17|0.34||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.34|0.17|<0.0001
71753652|NCT03186209|143010172|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0126|TWO_SIDED|95.0|-0.45|-0.05||Test after significant primary endpoint. Two secondary endpoints (change in FEV1 and total asthma symptom score) using Holm's procedure; smaller p-value to be \<0.025, and larger p-value to be \<0.05.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.05|-0.45|0.0126
71753653|NCT03186209|143010173|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1835|TWO_SIDED|95.0|-0.42|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma rescue medication use, region, use of maintenance oral corticosteroids, visit, treatment\*visit||||0.08|-0.42|0.1835
71753654|NCT03186209|143010174|SUPERIORITY||Mean Difference (Final Values)|38.66|||<|0.0001|TWO_SIDED|95.0|24.24|53.07||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline morning PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||53.07|24.24|<0.0001
71753655|NCT03186209|143010175|SUPERIORITY||Mean Difference (Final Values)|35.85|||<|0.0001|TWO_SIDED|95.0|21.52|50.18||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline evening PEF, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||50.18|21.52|<0.0001
71836541|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.07|STANDARD_ERROR_OF_MEAN|0.03||0.0359|TWO_SIDED|90.0|-0.13|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||-0.02|-0.13|0.0359
71836542|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.13|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.19|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||-0.06|-0.19|0.0022
71753656|NCT03186209|143010176|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.3385|TWO_SIDED|95.0|-0.03|0.01||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline proportion of nights awakening, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.01|-0.03|0.3385
71753657|NCT03186209|143010177|SUPERIORITY||Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.58|-0.28||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline ACQ-6 score, use of maintenance oral corticosteroids, visit, and treatment by visit||||-0.28|-0.58|<0.0001
71753658|NCT03186209|143010178|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.23|0.43||Nominal p-value. Not multiplicity protected by testing procedure.|Regression, Cox|model including covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids||||0.43|0.23|<0.0001
71753659|NCT03186209|143010179|SUPERIORITY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.19|0.42||Nominal p-value. Not multiplicity protected by testing procedure.|Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year (2, \>=3), use of OCS||||0.42|0.19|<0.0001
71891889|NCT03193866|143305377|SUPERIORITY||Difference in proportion|-2.6|||||TWO_SIDED|95.0|-8.6|3.4||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||3.4|-8.6|
71753660|NCT03186209|143010180|SUPERIORITY||Mean Difference (Final Values)|-9.19|||<|0.0001|TWO_SIDED|95.0|-12.79|-5.6||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model with covariates: treatment group, baseline SGRQ total score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-5.60|-12.79|<0.0001
71753661|NCT03186209|143010181|SUPERIORITY||Rate ratio|0.46||||0.0222|TWO_SIDED|95.0|0.24|0.9||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model includes Treatment, use of maintenance oral corticosteroids, categorical variable of ER/UC or hospitalization exacerbations during previous year||||0.90|0.24|0.0222
71786214|NCT02509156|143070810|SUPERIORITY||slope of time|-0.14|STANDARD_ERROR_OF_MEAN|0.35||0.689|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.689
71786215|NCT02509156|143070811|SUPERIORITY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|6.46||0.935|TWO_SIDED|95.0|-12.33|14.45|||ANCOVA||Confidence intervals based on t-test|The change in LVEDVI was compared using ANCOVA analyses adjusting for baseline values.||14.45|-12.33|0.935
71786216|NCT02509156|143070812|SUPERIORITY||slope of time|-1.56|STANDARD_ERROR_OF_MEAN|1.55||0.325|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.325
71786217|NCT02509156|143070813|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|5.99||0.919|TWO_SIDED|95.0|-11.75|13.08|||ANCOVA||Confidence intervals based on t-test|The change in LVESVI was compared using ANCOVA analyses adjusting for baseline values.||13.08|-11.75|0.919
71786218|NCT02509156|143070814|SUPERIORITY||slope of time|-1.99|STANDARD_ERROR_OF_MEAN|1.45||0.183|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.183
71786219|NCT02509156|143070815|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.035||0.124|TWO_SIDED|95.0|0.003|0.15|||ANCOVA||Confidence intervals based on t-test|The change in LV sphericity index was compared using ANCOVA analyses adjusting for baseline values.||0.15|0.003|0.124
71786220|NCT02509156|143070816|SUPERIORITY|||||||||||||||||Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. A time by treatment interaction was assessed.|There was a significant treatment and time interaction (p=0.024), so we report a slope for each treatment arm.|||
71786221|NCT02509156|143070817|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.14||0.993|TWO_SIDED|95.0|-3.05|1.74|||ANCOVA||Confidence intervals based on t-test|The change in scar percent was compared using ANCOVA analyses adjusting for baseline values.||1.74|-3.05|0.993
71786222|NCT02509156|143070818|SUPERIORITY||slope of time|-0.44|STANDARD_ERROR_OF_MEAN|0.29||0.151|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.151
71786223|NCT02509156|143070819|SUPERIORITY||Mean Difference (Final Values)|38.03|STANDARD_ERROR_OF_MEAN|20.96||0.056|TWO_SIDED|95.0|-5.84|81.89|||ANCOVA||Confidence intervals based on t-test|The change in distance walked was compared using ANCOVA analyses adjusting for baseline values.||81.89|-5.84|0.056
71836543|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.104|TWO_SIDED|90.0|-0.15|0.0|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.00|-0.15|0.1040
71836544|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.12|STANDARD_ERROR_OF_MEAN|0.04||0.0022|TWO_SIDED|90.0|-0.18|-0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||-0.06|-0.18|0.0022
71836545|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.08|STANDARD_ERROR_OF_MEAN|0.04||0.0331|TWO_SIDED|90.0|-0.14|-0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||-0.02|-0.14|0.0331
71845430|NCT03542305|143205143|OTHER||Ratio (%) of Adjusted Geometric Means|92.32|||||TWO_SIDED|90.0|56.58|150.63|||ANOVA|The natural log transformed parameter was used.|Normal renal function was the reference group. Severe renal impairment was test group. The estimate was derived from ratio (%) of adjusted geometric means of Test and Reference.|||150.63|56.58|
71786224|NCT02509156|143070820|SUPERIORITY||slope of time|2.82|STANDARD_ERROR_OF_MEAN|5.06||0.583|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.583
71786225|NCT02509156|143070821|SUPERIORITY||Mean Difference (Final Values)|-12.82|STANDARD_ERROR_OF_MEAN|8.37||0.048|TWO_SIDED|95.0|-30.49|4.84|||ANCOVA||Confidence intervals based on t-test|The change in MLHFQ summary score was compared using ANCOVA analyses adjusting for baseline values.||4.84|-30.49|0.048
71753662|NCT03186209|143010185|SUPERIORITY||Mean Difference (Final Values)|-119.31|||<|0.0001|TWO_SIDED|95.0|-169.78|-68.84||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|model includes treatment , baseline eosinophil count, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||-68.84|-169.78|<0.0001
71669712|NCT01730053|142856845|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.9|||<|0.0001|TWO_SIDED|98.75|-38.6|-9.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-9.1|-38.6|<0.0001
71669713|NCT01730053|142856845|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-23.6|||=|0.0001|TWO_SIDED|98.75|-39.0|-8.2||Threshold for significance ≤ 0.0125.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.||-8.2|-39.0|=0.0001
71669714|NCT01730053|142856846|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.4|||=|0.0311|TWO_SIDED|98.75|-1.2|16.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.||16.1|-1.2|=0.0311
71753663|NCT03186209|143010186|SUPERIORITY||Rate Ratio|0.83||||0.4519|TWO_SIDED|95.0|0.51|1.35||Nominal p-value. Not multiplicity protected by testing procedure.|Negative binomial|Model with covariates: treatment group, region (China/Non-China), number of exacerbations in previous year, use of maintenance oral corticosteroids||||1.35|0.51|0.4519
71753664|NCT03186209|143010187|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.0214|TWO_SIDED|95.0|0.02|0.22||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline pre-bronchodilator FEV1, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.22|0.02|0.0214
71753665|NCT03186209|143010188|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.1589|TWO_SIDED|95.0|-0.51|0.08||Nominal p-value. Not multiplicity protected by testing procedure.|Mixed Models Analysis|Model includes Treatment, baseline total asthma symptom score, region, use of maintenance oral corticosteroids, visit, and treatment by visit||||0.08|-0.51|0.1589
71753666|NCT00333775|143010205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0318|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0318
71753667|NCT00333775|143010205|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.72||||0.0036|TWO_SIDED|95.0|0.57|0.9|||Log Rank|||||0.90|0.57|0.0036
71753668|NCT00333775|143010208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1105|TWO_SIDED|95.0|0.69|1.04|||Log Rank|||||1.04|0.69|0.1105
71753669|NCT00333775|143010208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0241|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||||0.97|0.65|0.0241
71753670|NCT00333775|143010209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6962|TWO_SIDED|95.0|0.62|1.37|||Log Rank|||||1.37|0.62|0.6962
71753671|NCT00333775|143010209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0765|TWO_SIDED|95.0|0.45|1.04|||Log Rank|||||1.04|0.45|0.0765
71786226|NCT02509156|143070822|SUPERIORITY||slope of time|-8.07|STANDARD_ERROR_OF_MEAN|1.86||0.0002|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope."|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported.||||0.0002
71786227|NCT02509156|143070823|SUPERIORITY||Mean Difference (Final Values)|-315.8|STANDARD_ERROR_OF_MEAN|295.0||0.199|TWO_SIDED|95.0|-947.5|315.8|||ANCOVA||Confidence intervals based on t-test|The change in NT-proBNP was compared using ANCOVA analyses adjusting for baseline values. Data log transformed. p-values were obtained from transformed data.||315.80|-947.50|0.199
71786228|NCT02509156|143070824|SUPERIORITY||slope of time|-23.391|STANDARD_ERROR_OF_MEAN|202.08||0.229|TWO_SIDED|||||No adjustments for multiplicity were made in this Phase I trial.|Repeated Measures Linear Regression||"Standard error of the mean is the standard error of the estimate over time of the slope"|Repeated-measures linear regression models were used to address trajectories (upward or downward trends) over time within each of the treatment groups. If there was no significant interaction, only one trajectory (slope) was reported. Log transformation used for the regression. p-values were obtained from transformed data.||||0.229
71753672|NCT01856270|143010244|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.114||||0.101|ONE_SIDED|95.0|-0.017|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.|||-0.017|.101
71786229|NCT01750242|143070842|SUPERIORITY_OR_OTHER_LEGACY||% of leads|86.5|||||ONE_SIDED|95.0|73.7|||||||A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.|||73.7|
71786230|NCT01750242|143070843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.5|STANDARD_DEVIATION|8.7|||TWO_SIDED|95.0|-26.5|-18.4||||||Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.||-18.4|-26.5|
71786231|NCT04380116|143070917|SUPERIORITY|||||||0.366|||||||ANOVA|||||||.366
71845431|NCT02195232|143205154|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
71845432|NCT00731614|143205157|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322|||||||Repeated Measure ANOVA|||Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.||||.322
71845433|NCT03229408|143205162|SUPERIORITY||||||<|0.004|||||||Unpaired t-test, 2-Sided|||||||<0.004
71669715|NCT05085834|142856857|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.01|TWO_SIDED|95.0|0.43|0.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zinc, μg/dL)||0.98|0.43|<0.01
71669716|NCT05085834|142856858|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.002|STANDARD_ERROR_OF_MEAN|0.29||1|TWO_SIDED|95.0|-0.57|0.57|||linear combination of coefficients|||effect of Zinc supplementation on ln(hsCRP ng/mL)||0.57|-0.57|1.00
71753673|NCT01856270|143010245|SUPERIORITY|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.194||||0.017|ONE_SIDED|95.0|0.057|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain \>=6.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening|||.057|.017
71753674|NCT01856270|143010246|SUPERIORITY||Difference of proportions|0.093||||0.456|TWO_SIDED|95.0|-0.106|0.286||A priori significance threshold α=.05|Fisher Exact||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).|||.286|-.106|.456
71786232|NCT02408315|143070921|NON_INFERIORITY|Estimates obtained from Kaplan-Meier method and results of Log-rank test. P-value for non-inferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs. HA: HR \> .74), p-value \< .05 provides evidence to reject inferiority and conclude BM is non-inferior to VM.||||||0.663|||||||Cox proportional|||||||0.663
71753675|NCT01856270|143010247|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.684|TWO_SIDED|95.0|-5.1|3.4||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||3.4|-5.1|.684
71753676|NCT01856270|143010248|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.306|TWO_SIDED|95.0|-1.0|2.9||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||2.9|-1.0|.306
71753677|NCT01856270|143010249|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.583|TWO_SIDED|95.0|-0.9|1.6||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||1.6|-0.9|.583
71753678|NCT01856270|143010250|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.444|TWO_SIDED|95.0|-4.0|8.8||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||8.8|-4.0|.444
71753679|NCT01856270|143010251|SUPERIORITY||Mean Difference (Final Values)|27.3||||0.041|TWO_SIDED|95.0|1.2|53.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||53.3|1.2|.041
71753680|NCT01856270|143010252|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.089|TWO_SIDED|95.0|-3.8|0.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)|||0.3|-3.8|.089
71753681|NCT01451606|143010297|SUPERIORITY|||||||0.52||||||Note that sample size was well below our target, making this test very low power.|Wilcoxon (Mann-Whitney)|||||||0.52
71669717|NCT05085834|142856858|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.08|TWO_SIDED|95.0|-0.18|0.01|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD14, ng/mL)||0.01|-0.18|0.08
71753682|NCT01451606|143010298|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71753683|NCT03668873|143010308|SUPERIORITY||Difference of Least Squares Means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.88|-0.81||Threshold for significance was p=0.05.|Mixed Models Analysis|Mixed models with repeated measures with fixed effects for baseline CSI, treatment, week as a categorical variable, and treatment-week interaction.|Treatment difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on change in CSI score at 10 weeks. Assuming a standard deviation of 2.5 units and an attrition rate of 10%, an enrollment target of 90 participants would provide 90% power to detect a difference of 1.85 points or greater with a type I error rate of 0.05 using a two-tailed two-sample t-test.||-0.81|-2.88|<0.001
71753684|NCT03668873|143010309|SUPERIORITY||Absolute percent difference|24.0||||0.037|TWO_SIDED|95.0|2.0|46.0||Threshold for significance was 0.05|Chi-squared||Difference = SPT minus SPE.|The null hypothesis was that the SPE and SPT groups did not differ on the rate of positive response to CGI-I at 10 weeks. Assuming a 25%-40% positive response rate at 10 weeks in the SPE group and 45 patients per group, power was 90% to detect a 32% or greater difference in positive response rate (57%-72% in SPT group, respectively), with a type I error rate of 0.05 using a Chi-square test.||46|2|0.037
71753685|NCT03668873|143010310|SUPERIORITY|||||||0.81||||||threshold for significant 0.05|Mixed Models Analysis|||||||0.81
71786233|NCT01985867|143070939|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.399|TWO_SIDED|95.0|0.24|1.5|||risk analysis (prospective)|||||1.5|0.24|0.399
71786234|NCT01985867|143070940|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.2||||0.589|TWO_SIDED|95.0|-0.6|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.6|0.589
71786235|NCT01985867|143070941|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.0||||0.005|TWO_SIDED|95.0|0.5|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|0.5|0.005
71786236|NCT01985867|143070942|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.659|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.659
71786237|NCT01985867|143070943|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.790
71786238|NCT01985867|143070944|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.698|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.698
71836546|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.2149|TWO_SIDED|90.0|-0.11|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Left||0.02|-0.11|0.2149
71836547|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6896|TWO_SIDED|90.0|-0.08|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Amygdala Right||0.05|-0.08|0.6896
71836548|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.4769|TWO_SIDED|90.0|-0.06|0.02|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Left||0.02|-0.06|0.4769
71836549|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.768|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Anterior Cingulate Cortex Right||0.05|-0.07|0.7680
71836550|NCT03854578|143179011|OTHER|ANOVA model with treatment (BI 1358894 versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7997|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Left||0.06|-0.08|0.7997
71836551|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.8334|TWO_SIDED|90.0|-0.08|0.06|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Right||0.06|-0.08|0.8334
71836552|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.7402|TWO_SIDED|90.0|-0.07|0.05|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Left||0.05|-0.07|0.7402
71836553|NCT03854578|143179011|OTHER|ANOVA model with treatment (Citalopram versus placebo) and severity of depression (MADRS ≥20 versus \<20) as fixed effects. The Citalopram treatment arm was used as a positive control group. It was not planned to compare pharmacodynamic effects between Citalopram and BI 1358894.|Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.812|TWO_SIDED|90.0|-0.06|0.08|||ANOVA||Mean change calculated as: BI - Placebo.|Mean BOLD signal % change/ Insula Right||0.08|-0.06|0.8120
71836554|NCT05063994|143179022|NON_INFERIORITY|Non-inferiority of Chronocort to Cortef was declared if the 95% CI for the difference in biochemical response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above minus 15 percentage points.|Treatment Difference|25.7|STANDARD_ERROR_OF_MEAN|11.82||0.0003|TWO_SIDED|95.0|2.5|48.9||One-sided non-inferiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||48.9|2.5|0.0003
71836555|NCT05063994|143179023|SUPERIORITY|Superiority of Chronocort to Cortef with respect to the dose response after 28 weeks of randomized treatment was declared if the two-sided 95% CI for the difference in response rates between the 2 treatment arms (Chronocort minus Cortef) was wholly above zero, provided that non-inferiority of Chronocort to Cortef with respect to the biochemical response had been declared under the primary efficacy objective.|Treatment Difference|25.3|STANDARD_ERROR_OF_MEAN|11.24||0.012|TWO_SIDED|95.0|3.3|47.3||One-sided superiority. The Ge et al (2011) method was used to calculate the estimate, standard error, confidence interval and P-value for the treatment difference from the results of a logistic regression analysis.|Regression, Logistic|||||47.3|3.3|0.012
71836556|NCT05063994|143179024|SUPERIORITY|Superiority of Chronocort to Cortef (with respect to the total daily dose after 28 weeks of randomized treatment) was declared if the two-sided 95% CI for the difference in means between the 2 treatment arms (Chronocort minus Cortef) was wholly below zero, provided that non-inferiority of Chronocort to Cortef in terms of biochemical response had been declared under the primary efficacy objective, and superiority of Chronocort to Cortef in terms of dose response has been declared.|Treatment Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|-9.2|-2.5||One-sided superiority.|MMRM|||||-2.5|-9.2|0.0005
71836557|NCT00616967|143179047|SUPERIORITY_OR_OTHER_LEGACY||Pathological complete response rate|0.274|||||TWO_SIDED|95.0|0.169|0.402|||||The Estimation Parameter provided above is for overall pCR for both arms combined. We estimated pCR for each arm separately as well.|Patients were stratified by hormone receptor status and randomly assigned to either arm 1 or 2. This study was designed using Simon's two-stage design for each arm in parallel. Interim analysis of early stopping for futility was conducted for the first 32 patients (16 patients per arm) and the study proceeded as more than 2 patients achieved a pCR in each arm (31 patients per arm). This design had 80% power to detect a 25% pCR rate versus a null rate of 10% with a type I error rate of 0.10.||0.402|0.169|
71836558|NCT00616967|143179047|SUPERIORITY_OR_OTHER_LEGACY||pCR in placebo arm (arm 1)|0.29|||||TWO_SIDED|95.0|0.142|0.48||||||||0.48|0.142|
71677166|NCT02989649|142872960|OTHER||Least Square Mean (LSM)|-1.25|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-1.44|-1.05|||Regression, Linear||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|<0.001
71786239|NCT01985867|143070945|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|2.3||||0.12|TWO_SIDED|95.0|0.9|6.2|||risk analysis (prospective)|||||6.2|0.9|0.120
71786240|NCT01985867|143070946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
71786241|NCT01985867|143070947|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.5||||0.612|TWO_SIDED|95.0|-0.6|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.6|0.612
71786242|NCT01985867|143070948|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.0||||0.004|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.0|0.0|0.004
71786243|NCT01985867|143070949|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.708|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.708
71786244|NCT01985867|143070950|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.522|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|-1.0|0.522
71786245|NCT01985867|143070951|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.185|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.0|0.0|0.185
71786246|NCT01985867|143070952|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.973
71786247|NCT01985867|143070953|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.642|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|0.0|0.642
71786248|NCT01025752|143070967|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|0.07||||0.007|TWO_SIDED|95.0|-0.67|0.8||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.80) fell below the non-inferiority margin of 1.|post-treatment (12 weeks) time point||0.80|-0.67|0.007
71836559|NCT00616967|143179047|SUPERIORITY_OR_OTHER_LEGACY||pCR in vorinostat arm (arm 2)|0.258|||||TWO_SIDED|95.0|0.119|0.446||||||||0.446|0.119|
71836560|NCT00616967|143179050|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1||||0.023|TWO_SIDED|95.0|1.3|22.7|||Regression, Logistic|||The estimates provided are based upon a multivariate analysis using a logistic regression adjusting for hormone receptor status. Patients with ≥50% reduction in SULmax were more likely to achieve a pCR.||22.7|1.3|0.023
71836561|NCT02910583|143179059|SUPERIORITY||Difference in Rates|4.7||||0.1475|TWO_SIDED|95.0|-1.6|10.9||P-value is from Z test for the difference of two proportions based on Kaplan-Meier estimates with standard error of each arm computed using Greenwood's formula.|Z test||comparison: ibrutininb vs. placebo|||10.9|-1.6|0.1475
71836562|NCT02910583|143179060|SUPERIORITY||||||<|0.0001||||||One-sided P-value from asymptotic test for the binomial proportion (CRR \<= 37% vs CRR \> 37%).|asymptotic test for binomial proportion|||||||< 0.0001
71836563|NCT03205800|143179089|SUPERIORITY||||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
71836564|NCT01007591|143179119|SUPERIORITY||Mean Difference (Final Values)|-6.02||||0.75|TWO_SIDED|95.0|-43.7|31.7|||ANOVA|Treatment comparison using an ANOVA model with age group and treatment as design variables.||||31.7|-43.7|0.75
71836565|NCT04083235|143179124|OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Stratified log-rank test||The HR and 95% confidence interval (CI) was based on a stratified Cox proportional hazards regression model, stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status, region and liver metastases as per IWRS.|||0.99|0.70|0.04
71836566|NCT04083235|143179125|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.83|||Stratified log-rank test||The HR and 95% CI was based on a stratified Cox proportional hazards regression model, stratified by baseline ECOG performance status, region and liver metastases as per IWRS.|||0.83|0.58|<0.0001
71836567|NCT04083235|143179126|OTHER||Odds Ratio (OR)|1.26||||0.11|TWO_SIDED|95.0|0.95|1.69|||Cochran-Mantel-Haenszel||OR, 95% CI and p-value were obtained from the Cochran-Mantel-Haenszel test adjusting by baseline ECOG performance status, region and liver metastases as per IWRS.|||1.69|0.95|0.11
71836568|NCT02549339|143179127|SUPERIORITY||Ratio of clearance rates|7.57||||0.001|TWO_SIDED|95.0|2.26|25.31|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||25.31|2.26|0.001
71836569|NCT02549339|143179128|SUPERIORITY||Ratio of clearance rates|5.9|||<|0.001|TWO_SIDED|95.0|3.3|10.54|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.54|3.30|<0.001
71836570|NCT02549339|143179129|SUPERIORITY||Ratio of clearance rates|5.75|||<|0.001|TWO_SIDED|95.0|3.24|10.2|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.20|3.24|<0.001
71836571|NCT02549339|143179130|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.35||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.35|0.25|<0.001
71836572|NCT03381261|143179144|OTHER|While descriptive statistics were presented in the original mRNA units using median and interquartile range (25th, 75th), statistical group comparison and effect sizes were reported as the ratio of the geometric means.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71845434|NCT03229408|143205163|SUPERIORITY||||||<|0.03|||||||Unpaired T-test, 2-Sided|||||||<0.03
71845435|NCT03229408|143205164|SUPERIORITY|||||||0.18|||||||Unpaired t-test, 2-Sided|||||||0.180
71845436|NCT03229408|143205165|SUPERIORITY||||||<|0.002|||||||Unpaired T-test, 2-Sided|||||||<0.002
71845437|NCT03229408|143205166|SUPERIORITY||||||<|0.04|||||||Unpaired t-test, 2-Sided|||||||<0.04
71845438|NCT03229408|143205167|SUPERIORITY||||||<|0.003|||||||Unpaired t-test, 2-Sided|||||||<0.003
71669718|NCT05085834|142856858|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.77|TWO_SIDED|95.0|-0.21|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(sCD163, ng/mL)||0.15|-0.21|0.77
71669719|NCT05085834|142856858|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.19|TWO_SIDED|95.0|-0.1|0.5|||linear combination of coefficients|||effect of Zinc supplementation on ln(D-dimer, ng/mL)||0.50|-0.10|0.19
71669720|NCT05085834|142856858|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1|TWO_SIDED|95.0|-0.41|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(VCAM, ng/mL)||0.04|-0.41|0.10
71669721|NCT05085834|142856858|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.41|STANDARD_ERROR_OF_MEAN|20.19||0.98|TWO_SIDED|95.0|-39.16|39.98|||linear combination of coefficients|||effect of Zinc supplementation on ln(ICAM, ng/mL)||39.98|-39.16|0.98
71669722|NCT05085834|142856859|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.55|TWO_SIDED|95.0|-0.09|0.16|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RI , pg/mL)||0.16|-0.09|0.55
71753686|NCT03668873|143010311|SUPERIORITY|||||||0.77||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.77
71786249|NCT01025752|143070967|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.23|||<|0.0001|TWO_SIDED|95.0|-0.94|0.49||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.49) fell below the non-inferiority margin of 1.|3 month post-baseline time point||0.49|-0.94|<0.0001
71845439|NCT03229408|143205168|SUPERIORITY||||||<|0.0004|||||||Unpaired t-test, 2-Sided|||||||<0.0004
71845440|NCT03229408|143205169|SUPERIORITY||||||<|0.007|||||||Unpaired t-test, 2-Sided|||||||<0.007
71669723|NCT05085834|142856859|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.004|STANDARD_ERROR_OF_MEAN|0.07||0.95|TWO_SIDED|95.0|-0.13|0.13|||linear combination of coefficients|||effect of Zinc supplementation on ln(sTNF-RII, pg/m)||0.13|-0.13|0.95
71669724|NCT05085834|142856859|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.19||0.73|TWO_SIDED|95.0|-0.3|0.43|||linear combination of coefficients|||effect of Zinc supplementation on ln(IL-6, pg/mL)||0.43|-0.30|0.73
71669725|NCT05085834|142856859|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.12|STANDARD_ERROR_OF_MEAN|0.18||0.48|TWO_SIDED|95.0|-0.22|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(IP-10, pg/mL)||0.47|-0.22|0.48
71677167|NCT02989649|142872961|OTHER|||||||0.423|||||||Regression, Linear|||Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used||||0.423
71677168|NCT02989649|142872961|OTHER|||||||0.747|||||||Regression, Linear|||Statistical analysis for subgroup: Sex, Male or Female||||0.747
71677169|NCT02989649|142872961|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Age, \<45 or \>=45 to \<65 years or \>=65 years||||<0.001
71753687|NCT03668873|143010312|SUPERIORITY|||||||0.003||||||Threshold for significance was 0.05|Mixed Models Analysis|||||||0.003
71753688|NCT02183675|143010314|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|108.39|STANDARD_ERROR_OF_MEAN|1.094|||TWO_SIDED|90.0|93.081|126.225|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||126.225|93.081|
71753689|NCT02183675|143010314|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|114.86|STANDARD_ERROR_OF_MEAN|1.097|||TWO_SIDED|90.0|98.216|134.326|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||134.326|98.216|
71753690|NCT02183675|143010315|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|97.53|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|90.43|105.19|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||105.19|90.43|
71753691|NCT02183675|143010315|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.04|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|96.94|107.4|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||107.40|96.94|
71753692|NCT02183675|143010316|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|104.8|STANDARD_ERROR_OF_MEAN|1.016|||TWO_SIDED|90.0|101.949|107.734|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||107.734|101.949|
71786250|NCT01025752|143070967|NON_INFERIORITY|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.08||||0.004|TWO_SIDED|95.0|-0.86|0.71||The non-inferiority margin is 1.|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA \& back pain cause)|The upper limit (0.71) fell below the non-inferiority margin of 1.|6 month post- baseline time point.||0.71|-0.86|0.004
71786251|NCT01025752|143070968|OTHER||Mean Difference (Final Values)|-0.33||||0.12|TWO_SIDED|95.0|-0.74|0.09|||Mixed Models Analysis|||Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.09|-0.74|0.12
71786252|NCT01025752|143070968|OTHER||Mean Difference (Final Values)|-0.34||||0.2|TWO_SIDED|95.0|-0.87|0.18|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.18|-0.87|0.20
71786253|NCT01025752|143070968|OTHER||Mean Difference (Final Values)|-0.02||||0.93|TWO_SIDED|95.0|-0.57|0.52|||Mixed Models Analysis|||6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)||0.52|-0.57|0.93
71786254|NCT01025752|143070969|OTHER||Mean Difference (Final Values)|-0.5||||0.58|TWO_SIDED|95.0|-2.29|1.29|||Mixed Models Analysis|||post-treatment (12 weeks) time point||1.29|-2.29|0.58
71786255|NCT01025752|143070969|OTHER||Mean Difference (Final Values)|-1.53||||0.12|TWO_SIDED|95.0|-3.46|0.41|||Mixed Models Analysis|||3 months post-baseline time point||0.41|-3.46|0.12
71786256|NCT01025752|143070969|OTHER||Mean Difference (Final Values)|-0.61||||0.51|TWO_SIDED|95.0|-2.42|1.2|||Mixed Models Analysis|||6 months post-baseline time point||1.20|-2.42|0.51
71786257|NCT01025752|143070970|OTHER||Mean Difference (Final Values)|0.29||||0.83|TWO_SIDED|95.0|-2.3|2.87|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||2.87|-2.30|0.83
71786258|NCT01025752|143070970|OTHER||Mean Difference (Final Values)|1.15||||0.42|TWO_SIDED|95.0|-1.68|3.98|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||3.98|-1.68|0.42
71786259|NCT01025752|143070970|OTHER||Mean Difference (Final Values)|-0.58||||0.68|TWO_SIDED|95.0|-3.4|2.24|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.24|-3.40|0.68
71786260|NCT01025752|143070971|OTHER||Mean Difference (Final Values)|1.25||||0.4|TWO_SIDED|95.0|-1.66|4.16|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||4.16|-1.66|0.40
71786261|NCT01025752|143070971|OTHER||Mean Difference (Final Values)|0.38||||0.81|TWO_SIDED|95.0|-2.82|3.58|||Mixed Models Analysis|||3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)||3.58|-2.82|0.81
71786262|NCT01025752|143070971|OTHER||Mean Difference (Final Values)|2.43||||0.16|TWO_SIDED|95.0|-0.96|5.82|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||5.82|-0.96|0.16
71786263|NCT01025752|143070972|OTHER||Mean Difference (Final Values)|0.24||||0.85|TWO_SIDED|95.0|-2.32|2.8|||Mixed Models Analysis|||post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)||2.80|-2.32|0.85
71786264|NCT01025752|143070972|OTHER||Mean Difference (Final Values)|-1.27||||0.4|TWO_SIDED|95.0|-4.27|1.73|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.73|-4.27|0.40
71786265|NCT01025752|143070972|OTHER||Mean Difference (Final Values)|-0.74||||0.68|TWO_SIDED|95.0|-4.3|2.83|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||2.83|-4.30|0.68
71786266|NCT01025752|143070973|OTHER||Mean Difference (Final Values)|-0.94||||0.17|TWO_SIDED|95.0|-2.28|0.4|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)||0.40|-2.28|0.17
71786267|NCT01025752|143070973|OTHER||Mean Difference (Final Values)|-0.12||||0.86|TWO_SIDED|95.0|-1.39|1.16|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.16|-1.39|0.86
71786268|NCT01025752|143070973|OTHER||Mean Difference (Final Values)|0.37||||0.64|TWO_SIDED|95.0|-1.22|1.97|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)||1.97|-1.22|0.64
71786269|NCT02289417|143071059|SUPERIORITY||Stratified Difference|19.2||||0.0142|TWO_SIDED|95.0|3.4|33.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of oral (PO) corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.6|3.4|0.0142
71786270|NCT02289417|143071059|SUPERIORITY||Stratified Difference|7.7||||0.2689|TWO_SIDED|95.0|-6.9|22.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method|||22.0|-6.9|0.2689
71786271|NCT02289417|143071060|SUPERIORITY||Stratified Difference|14.6||||0.1224|TWO_SIDED|95.0|-3.6|31.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.5|-3.6|0.1224
71669726|NCT05085834|142856860|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|1819.18|STANDARD_ERROR_OF_MEAN|8530.03||0.83|TWO_SIDED|95.0|-14899.37|18537.74|||linear combination of coefficients|||effect of Zinc supplementation on ln(OxLDL, U/L)||18537.74|-14899.37|0.83
71786272|NCT02289417|143071060|SUPERIORITY||Stratified Difference|19.4||||0.0401|TWO_SIDED|95.0|1.1|36.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.0|1.1|0.0401
71786273|NCT02289417|143071061|SUPERIORITY||Stratified Difference|5.2||||0.2472|TWO_SIDED|95.0|-5.7|16.7|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||16.7|-5.7|0.2472
71786274|NCT02289417|143071061|SUPERIORITY||Stratified Difference|3.1||||0.4628|TWO_SIDED|95.0|-7.5|14.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||14.6|-7.5|0.4628
71786275|NCT02289417|143071062|SUPERIORITY||Stratified Difference|32.0||||0.0005|TWO_SIDED|95.0|13.8|47.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.4|13.8|0.0005
71786276|NCT02289417|143071062|SUPERIORITY||Stratified Difference|3.7||||0.6878|TWO_SIDED|95.0|-14.4|21.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.5|-14.4|0.6878
71786277|NCT02289417|143071063|SUPERIORITY||Stratified Difference|11.5||||0.1388|TWO_SIDED|95.0|-4.1|26.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||26.1|-4.1|0.1388
71786278|NCT02289417|143071063|SUPERIORITY||Stratified Difference|13.5||||0.0788|TWO_SIDED|95.0|-1.6|27.7||Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Cochran-Mantel-Haenszel||Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||27.7|-1.6|0.0788
71786279|NCT02289417|143071064|SUPERIORITY||Stratified Difference|24.8||||0.0046|TWO_SIDED|95.0|7.5|40.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||40.1|7.5|0.0046
71786280|NCT02289417|143071064|SUPERIORITY||Stratified Difference|6.0||||0.4476||95.0|-9.8|21.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||21.6|-9.8|0.4476
71786281|NCT02289417|143071065|SUPERIORITY||Stratified Difference|16.7||||0.0755|TWO_SIDED|95.0|-1.4|33.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.5|-1.4|0.0755
71786282|NCT02289417|143071065|SUPERIORITY||Stratified Difference|19.8||||0.037|TWO_SIDED|95.0|1.5|36.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||36.4|1.5|0.0370
71786283|NCT02289417|143071066|SUPERIORITY||Stratified Difference|14.6||||0.1167|TWO_SIDED|95.0|-3.3|31.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||31.4|-3.3|0.1167
71786284|NCT02289417|143071066|SUPERIORITY||Stratified Difference|18.1||||0.0534|TWO_SIDED|95.0|-0.3|34.9|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||34.9|-0.3|0.0534
71786285|NCT02289417|143071067|SUPERIORITY||Stratified Difference|16.6||||0.0758|TWO_SIDED|95.0|-1.5|33.3|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||33.3|-1.5|0.0758
71669727|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.84|TWO_SIDED|95.0|-0.12|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(Non-HDL Cholesterol (mg/dL))||0.15|-0.12|0.84
71753693|NCT02183675|143010317|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.95|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|90.0|101.023|106.964|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||106.964|101.023|
71669728|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.08|STANDARD_ERROR_OF_MEAN|0.06||0.18|TWO_SIDED|95.0|-0.19|0.04|||linear combination of coefficients|||effect of Zinc supplementation on ln(HDL (mg/dL))||0.04|-0.19|0.18
71753694|NCT02183675|143010318|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|102.49|STANDARD_ERROR_OF_MEAN|1.014|||TWO_SIDED|90.0|100.167|104.867|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-A5|||104.867|100.167|
71753695|NCT02183675|143010319|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|105.35|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|99.23|111.847|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||111.847|99.230|
71753696|NCT02183675|143010320|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limits: 80% - 125%|Adjusted geometric mean ratio (%)|103.39|STANDARD_ERROR_OF_MEAN|1.028|||TWO_SIDED|90.0|98.73|108.28|||ANOVA|The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.|Ratio calculated as T80-A5-H12.5 divided by T80-H12.5|||108.280|98.730|
71753697|NCT02761330|143010348|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
71753698|NCT02761330|143010348|OTHER|||||||0.012||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.012
71753699|NCT02761330|143010348|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
71753700|NCT02761330|143010348|OTHER|||||||0.203||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Digital Symbol Substitution Task (DSST) reaction time.||||0.203
71753701|NCT02761330|143010348|OTHER|||||||0.008||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.008
71753702|NCT02761330|143010348|OTHER|||||||0.496||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Motor Praxis Task (MP) reaction time.||||0.496
71753703|NCT02761330|143010348|OTHER|||||||0.844||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.844
71753704|NCT02761330|143010348|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Visual Object Learning Task (VOLT) reaction time.||||0.016
71753705|NCT02761330|143010348|OTHER|||||||0.062||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.062
71753706|NCT02761330|143010348|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Abstract Matching task (AM) reaction time.||||0.039
71753707|NCT02761330|143010349|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Psychomotor Vigilance Task (PVT) reaction time.||||0.016
71753708|NCT02761330|143010349|OTHER|||||||0.039||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the recovery rate of Psychomotor Vigilance Task (PVT) reaction time.||||0.039
71753709|NCT02761330|143010349|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||0.031
71753710|NCT02761330|143010349|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Digital Symbol Substitution Task (DSST) reaction time.||||1.0
71753711|NCT02761330|143010349|OTHER|||||||0.195||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.195
71753712|NCT02761330|143010349|OTHER|||||||0.57||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Motor Praxis task (MP) reaction time.||||0.570
71753713|NCT02761330|143010349|OTHER|||||||0.031||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.031
71753714|NCT02761330|143010349|OTHER|||||||0.016||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Visual Object Learning Task (VOLT) reaction time.||||0.016
71753715|NCT02761330|143010349|OTHER|||||||1||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Etomidate + ECT and Ketamine + ECT groups for the initial decrement of Abstract Matching (AM) task reaction time.||||1.00
71836573|NCT03761537|143179150|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.018|TWO_SIDED|95.0|2.5|25.7||This endpoint was the first endpoint in the sequential testing hierarchy.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.7|2.5|0.018
71836574|NCT03761537|143179151|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|9.7||||0.106|TWO_SIDED|95.0|-2.0|21.4||This endpoint was the second endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||21.4|-2.0|0.106
71836575|NCT03761537|143179152|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.6|||<|0.001|TWO_SIDED|95.0|-13.0|-4.2||This was the third endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline SCORAD interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.2|-13.0|<0.001
71836576|NCT03761537|143179153|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.5||||0.009|TWO_SIDED|95.0|-2.6|-0.4||This was the fourth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Treatment effect at each visit adjusted for baseline DLQI interacting with each visit, prior CSA, and baseline disease severity (IGA 3 or 4).||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.4|-2.6|0.009
71753716|NCT02761330|143010349|OTHER|||||||0.109||||||Not adjusted for multiple comparisons.|Wilcoxon Signed-Ranked Test|||Comparison between the Ketamine + ECT and Ketamine Alone groups for the initial decrement of Abstract Matching (AM) task reaction time.||||0.109
71891890|NCT03193866|143305377|SUPERIORITY||Difference in proportion|3.8|||||TWO_SIDED|95.0|-4.7|12.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||12.2|-4.7|
71891891|NCT03193866|143305377|SUPERIORITY||Difference in proportion|0.6|||||TWO_SIDED|95.0|-6.9|8.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||8.1|-6.9|
71753717|NCT02761330|143010357|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
71753718|NCT02761330|143010357|OTHER|||||||0.301|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.301
71753719|NCT02761330|143010357|OTHER|||||||0.557|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the delta band at baseline compared to T0 following return of responsiveness.||||0.557
71677170|NCT02989649|142872961|OTHER|||||||0.99|||||||Regression, Linear|||Statistical analysis for subgroup: Cardiovascular risk group, Yes or No||||0.990
71677171|NCT02989649|142872961|OTHER|||||||0.841|||||||Regression, Linear|||Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy||||0.841
71753720|NCT02761330|143010358|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.910
71753721|NCT02761330|143010358|OTHER|||||||0.734|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.734
71753722|NCT02761330|143010358|OTHER|||||||0.322|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the theta band at baseline compared to T0 following return of responsiveness.||||0.322
71753723|NCT02761330|143010359|OTHER|||||||0.164|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.164
71753724|NCT02761330|143010359|OTHER|||||||0.039|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.039
71753725|NCT02761330|143010359|OTHER|||||||0.375|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the alpha band at baseline compared to T0 following return of responsiveness.||||0.375
71753726|NCT02761330|143010360|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
71753727|NCT02761330|143010360|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.910
71836577|NCT03761537|143179154|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|15.6||||0.005|TWO_SIDED|95.0|4.8|26.3||This endpoint was the fifth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||26.3|4.8|0.005
71845441|NCT03387189|143205199|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|0.39||||0.031|TWO_SIDED|95.0|0.17|0.91|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||0.91|0.17|0.031
71786286|NCT02289417|143071067|SUPERIORITY||Stratified Difference|32.5||||0.0004|TWO_SIDED|95.0|14.9|47.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.|||47.5|14.9|0.0004
71786287|NCT04786990|143071074|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71669729|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.84|TWO_SIDED|95.0|-0.19|0.15|||linear combination of coefficients|||effect of Zinc supplementation on ln(LDL (mg/dL))||0.15|-0.19|0.84
71786288|NCT04786990|143071074|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71677172|NCT02989649|142872961|OTHER|||||||0.847|||||||Regression, Linear|||Statistical analysis for subgroup: Baseline BMI, \<25 or 25 to \<30 or \>=30 kg/m\^2||||0.847
71753728|NCT02761330|143010360|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of relative power in the beta band at baseline compared to T0 following return of responsiveness.||||0.625
71753729|NCT02761330|143010361|OTHER|||||||0.129|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.129
71786289|NCT04786990|143071075|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71786290|NCT04786990|143071075|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71786291|NCT04786990|143071077|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71677173|NCT02989649|142872961|OTHER||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Initial glycemic control, \<7% or \>=7%||||<0.001
71753730|NCT02761330|143010361|OTHER|||||||0.91|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.910
71753731|NCT02761330|143010361|OTHER|||||||0.625|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior functional connectivity (coherence) at baseline compared to T0 following return of responsiveness.||||0.625
71753732|NCT02761330|143010362|OTHER|||||||1|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||1.000
71753733|NCT02761330|143010362|OTHER|||||||0.496|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.496
71753734|NCT02761330|143010362|OTHER|||||||0.16|||||||Wilcoxon signed-rank paired test|||Comparison of anterior-posterior phase-lag (PLI) at baseline compared to T0 following return of responsiveness.||||0.160
71753735|NCT02761330|143010363|OTHER|||||||0.008|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.008
71669730|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.11||0.55|TWO_SIDED|95.0|-0.15|0.29|||linear combination of coefficients|||effect of Zinc supplementation on ln(VLDL (mg/dL))||0.29|-0.15|0.55
71669731|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.78|TWO_SIDED|95.0|-0.11|0.09|||linear combination of coefficients|||effect of Zinc supplementation on ln(Cholesterol (mg/dl))||0.09|-0.11|0.78
71669732|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.58|TWO_SIDED|95.0|-0.17|0.31|||linear combination of coefficients|||effect of Zinc supplementation on ln(Triglycerides (mg/dL))||0.31|-0.17|0.58
71669733|NCT05085834|142856861|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.44|STANDARD_ERROR_OF_MEAN|0.47||0.35|TWO_SIDED|95.0|-1.36|0.48|||linear combination of coefficients|||effect of Zinc supplementation on Metabolic Syndrome||0.48|-1.36|0.35
71669734|NCT05085834|142856862|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.07||0.36|TWO_SIDED|95.0|-0.07|0.2|||linear combination of coefficients|||effect of Zinc supplementation on ln(Chol:HDL Ratio)||0.20|-0.07|0.36
71669735|NCT05085834|142856863|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.35|STANDARD_ERROR_OF_MEAN|2.01||0.86|TWO_SIDED|95.0|-4.29|3.6|||linear combination of coefficients|||effect of Zinc supplementation on BMI (kg/m2)||3.60|-4.29|0.86
71786292|NCT04786990|143071077|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0002
71669736|NCT05085834|142856864|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.74|TWO_SIDED|95.0|-0.08|0.05|||linear combination of coefficients|||effect of Zinc supplementation on ln(Waist-umbilicus (cm))||0.05|-0.08|0.74
71669737|NCT05085834|142856865|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-2.99|STANDARD_ERROR_OF_MEAN|12.23||0.81|TWO_SIDED|95.0|-26.97|20.99|||linear combination of coefficients|||effect of Zinc supplementation on Weight (lbs)||20.99|-26.97|0.81
71669738|NCT05085834|142856866|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.07|0.03|||linear combination of coefficients|||effect of Zinc supplementation on ln(Systolic blood pressure (mmHg))||0.03|-0.07|0.41
71669739|NCT05085834|142856866|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-1.68|STANDARD_ERROR_OF_MEAN|2.06||0.42|TWO_SIDED|95.0|-5.71|2.36|||linear combination of coeff|||effect of Zinc supplementation on Diastolic blood pressure (mmHg)||2.36|-5.71|0.42
71669740|NCT05085834|142856867|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7|TWO_SIDED|95.0|-0.26|0.17|||linear combination of coefficients|||effect of Zinc supplementation on ln(10 year ASCVD (%))||0.17|-0.26|0.70
71786293|NCT04786990|143071078|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71786294|NCT04786990|143071078|OTHER||||||<|0.0001||||||The p-value generated for the comparison between time points for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed. There is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71786295|NCT04786990|143071079|OTHER|||||||0.0685||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0685
71753736|NCT02761330|143010363|OTHER|||||||0.359|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.359
71753737|NCT02761330|143010363|OTHER|||||||0.375|||||||Wilcoxon Signed-Ranked Test|||Comparison of EEG Entropy using Permutation Entropy (PE) measures at baseline compared to T0 following return of responsiveness.||||0.375
71753738|NCT00980954|143010368|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.56|TWO_SIDED|90.0|0.65|1.68||One-sided significance level = 0.05.|Log Rank||Reference level = Arm I|Sample size calculations are based on the primary hypothesis that 4 additional cycles of carboplatin and paclitaxel following concurrent radiation and weekly cisplatin will increase 4-year DFS from 80% to 90% for patients with cervical carcinoma with positive nodes and/or positive margins after a radical hysterectomy. One-sided alpha=0.05, statistical power=80%, 5.5 years of accrual with 4 years of follow-up, 2 interim significance tests. 50 DFS events are required to trigger this analysis.||1.68|0.65|0.56
71753739|NCT00980954|143010369|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.4|TWO_SIDED|90.0|0.49|1.69||One-sided significance level = 0.05.|Log Rank|||The 4-year overall survival rate for the control arm is expected to be approximately 85%. The overall survival will be compared between the two arms. The final targeted sample size of 235 patients with the longer accrual time, will provide 64% and 78% power to detect an increase in overall survival to 92% and 93% respectively, with a 1- sided alpha of 0.05.||1.69|0.49|0.40
71753740|NCT04576988|143010407|OTHER||Treatment difference|40.8|||<|0.001|TWO_SIDED|95.0|27.53|54.14||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|Aligned Rank Stratified Wilcoxon (ARSW)|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% confidence interval (CI) was reported.|||54.14|27.53|<0.001
71753741|NCT04576988|143010410|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
71753742|NCT04576988|143010411|OTHER||Treatment difference|-234.6|||<|0.001|TWO_SIDED|95.0|-288.37|-180.75||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-180.75|-288.37|<0.001
71753743|NCT04576988|143010412|OTHER||Treatment difference|-441.6|||<|0.001|TWO_SIDED|95.0|-573.54|-309.61||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-309.61|-573.54|<.001
71753744|NCT04576988|143010413|OTHER|A 2-sided p-value was calculated using CMH method with WHO FC II/III and background PAH therapy as strata.|||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71753745|NCT04576988|143010414|OTHER|A 2-sided p-value was calculated using Log rank test with WHO FC II/III and background PAH therapy as strata.|Hazard Ratio (HR)|0.163|||<|0.001|TWO_SIDED|95.0|0.076|0.347|||Log Rank||Cox proportional hazard model was used to generate hazard ratio (HR) and 95% CI was reported with treatment group as the covariate stratified by the WHO FC II/III and background PAH therapy.|||0.347|0.076|<0.001
71786296|NCT04786990|143071079|OTHER|||||||0.2575||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.2575
71753746|NCT04576988|143010415|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|A 2-sided p-value was calculated using Cochran-Mantel-Haenszel (CMH) method with WHO FC II/III and background PAH therapy as strata.||||||<0.001
71753747|NCT04576988|143010416|OTHER||Treatment difference|-0.26||||0.01|TWO_SIDED|95.0|-0.49|-0.04||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.040|-0.490|0.010
71786297|NCT04786990|143071080|OTHER|||||||0.0832||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0832
71786298|NCT04786990|143071080|OTHER|||||||0.3715||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.3715
71786299|NCT04786990|143071081|OTHER|||||||0.0042||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||0.0042
71786300|NCT04786990|143071081|OTHER|||||||0.0019||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0019
71786301|NCT04786990|143071082|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 4||||<0.0001
71753748|NCT04576988|143010417|OTHER||Treatment difference|-0.13||||0.028|TWO_SIDED|95.0|-0.256|-0.014||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||-0.014|-0.256|0.028
71786302|NCT04786990|143071082|OTHER|||||||0.0025||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data|t-test, 2 sided|||Week 8||||0.0025
71753749|NCT04576988|143010418|OTHER||Treatment difference|-0.16||||0.156|TWO_SIDED|95.0|-0.399|0.084||A 2-sided p-value was calculated using ARSW test with WHO FC II/III and background PAH therapy as strata.|ARSW test|Participants who died were assigned the worst rank and who had missing data due to non-fatal clinical worsening event were assigned next worst-rank.|Hodges-Lehmann location-shift estimate of the overall treatment difference with 95% CI was reported.|||0.084|-0.399|0.156
71753750|NCT01576341|143010419|OTHER||Incidence rate|0.019|||||TWO_SIDED||||||||Incidence rate is based on duration of treatment period (years)|||||
71753751|NCT00617734|143010456|SUPERIORITY_OR_OTHER|||||||0.0667|||||||Log Rank|||||||0.0667
71753752|NCT00617734|143010457|SUPERIORITY_OR_OTHER|||||||0.1935|||||||Fisher Exact|||||||0.1935
71753753|NCT00617734|143010459|SUPERIORITY_OR_OTHER|||||||0.7455|||||||Log Rank|||||||0.7455
71786303|NCT04786990|143071083|OTHER|||||||0.0161||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0161
71786304|NCT04786990|143071083|OTHER|||||||0.0122||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||0.0122
71786305|NCT04786990|143071084|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71753754|NCT02485691|143010472|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73||P-value from 2-sided stratified log-rank test, stratified for ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization. Significance threshold was at 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.73|0.40|<0.0001
71786306|NCT04786990|143071084|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71669741|NCT05085834|142856868|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|-0.03|STANDARD_ERROR_OF_MEAN|0.07||0.62|TWO_SIDED|95.0|-0.17|0.1|||linear combination of coefficients|||effect of Zinc supplementation on Reactive Hyperemic Index||0.10|-0.17|0.62
71677174|NCT02989649|142872964|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-1.29|-0.62|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.62|-1.29|
71753755|NCT02485691|143010473|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.64||||0.0078|TWO_SIDED|95.0|0.46|0.89||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.89|0.46|0.0078
71758538|NCT02205736|143019222|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71786307|NCT04786990|143071085|OTHER|||||||0.0002||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||0.0002
71786308|NCT04786990|143071085|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71786309|NCT04786990|143071086|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71786310|NCT04786990|143071086|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71669742|NCT05085834|142856868|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.59|STANDARD_ERROR_OF_MEAN|2.43||0.81|TWO_SIDED|95.0|-4.19|5.36|||linear combination of coefficients|||effect of Zinc supplementation on Augmentation Index||5.36|-4.19|0.81
71786311|NCT04786990|143071087|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
71669743|NCT05085834|142856869|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.9|TWO_SIDED|95.0|-0.26|0.3|||linear combination of coefficients|||effect of Zinc supplementation on ln(IFAB (pg/mL))||0.30|-0.26|0.90
71669744|NCT05085834|142856869|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.18|STANDARD_ERROR_OF_MEAN|0.15||0.24|TWO_SIDED|95.0|-0.12|0.47|||linear combination of coefficients|||effect of Zinc supplementation on ln(BDG (pg/mL))||0.47|-0.12|0.24
71669745|NCT05085834|142856870|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.69|TWO_SIDED|95.0|-0.21|0.32|||v|||effect of Zinc supplementation on ln(LBP (ng/mL))||0.32|-0.21|0.69
71669746|NCT05085834|142856870|OTHER|Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.|β coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.49|TWO_SIDED|95.0|-0.16|0.34|||linear combination of coefficients|||effect of Zinc supplementation on ln(Zonulin (ng/mL)||0.34|-0.16|0.49
71669747|NCT00742209|142856895|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.3||||0.579|TWO_SIDED|95.0|-0.6|1.1||A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.|ANCOVA|An ANCOVA model with baseline number of MHD and IHS Headache Classification for presence or absence of aura as covariates was used.|Adjusted mean difference versus placebo|||1.1|-0.6|0.579
71669748|NCT02562066|142856914|OTHER||Mean Difference (Net)|1.63||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.085
71669749|NCT02562066|142856914|OTHER||Mean Difference (Net)|0.56|||||TWO_SIDED|95.0|-0.97|2.09|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with SGI raw scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||2.09|-0.97|
71669750|NCT02562066|142856915|OTHER||Mean Difference (Net)|3.17||||0.376|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.376
71669751|NCT02562066|142856915|OTHER||Mean Difference (Net)|1.14|||||TWO_SIDED|95.0|-2.31|4.58|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-32 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||4.58|-2.31|
71669752|NCT02562066|142856916|OTHER||Mean Difference (Net)|-1.0||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Results show the difference in mean CFB at the end of Study Period 1.|A Mann-Whitney-Wilcoxon test for equality of the change from baseline (CFB) in the two treatments in Period 1 will be presented.||||0.800
71669753|NCT02562066|142856916|OTHER||Mean Difference (Net)|0.63|||||TWO_SIDED|95.0|-5.25|6.5|||Mixed Models Analysis||Results show the LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.|A mixed effects linear model will be fit to the data with Overall MFM-20 scores as the response and fixed effect terms for treatment, period, age group, mutation type and sequence\*period, and a random effect for patient. The LSMeans for the estimated difference between treatments in Period 1 along with a 95% confidence interval for this difference.||6.50|-5.25|
71669754|NCT01998919|142856925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.34|||||TWO_SIDED|95.0|-10.3|17.0|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||17.0|-10.3|
71669755|NCT01998919|142856926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|||||TWO_SIDED|95.0|-5.6|26.8|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||26.8|-5.6|
71669756|NCT01998919|142856927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.48|||||TWO_SIDED|95.0|-2.7|27.7|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||27.7|-2.7|
71669757|NCT01998919|142856928|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Log Rank|||||||0.0075
71669758|NCT01998919|142856928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.0099|TWO_SIDED|95.0|0.22|0.81|||Wald test|||||0.81|0.22|0.0099
71669759|NCT01998919|142856929|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
71669760|NCT01998919|142856929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48||||0.0001|TWO_SIDED|95.0|0.33|0.7|||Wald Test|||||0.70|0.33|0.0001
71753756|NCT02485691|143010474|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||P-value from two-sided stratified log-rank test, stratified for ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Log Rank||Cabazitaxel vs Abiraterone Acetate or Enzalutamide|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was stratified by ECOG performance status, time from AR- targeted agent initiation progression, timing of AR targeted agent as specified at the time of randomization.||0.68|0.40|<0.0001
71753757|NCT02485691|143010475|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0003||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0003
71753758|NCT02485691|143010476|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.||||||0.0004||||||Cochran-Mantel-Haenszel test stratified by ECOG performance status, time from AR-targeted agent initiation to progression, timing of AR-targeted agent as specified at the time of randomization. Significance threshold = 0.05.|Cochran-Mantel-Haenszel|||||||0.0004
71753759|NCT03413891|143010518|SUPERIORITY||Risk Ratio (RR)|0.93|||=|0.72|TWO_SIDED|95.0|0.6|1.42|||Chi-squared|||||1.42|0.60|=0.72
71753760|NCT03413891|143010520|SUPERIORITY||Rate Ratio|0.76|||=|0.36|TWO_SIDED|95.0|0.42|1.37|||negative-binomial regression|||||1.37|0.42|=0.36
71753761|NCT03413891|143010521|SUPERIORITY||Rate Ratio|0.32|||=|0.03|TWO_SIDED|95.0|0.12|0.89|||negative-binomial regression|||||0.89|0.12|=0.03
71753762|NCT03413891|143010522|SUPERIORITY||Rate Ratio|0.6|||=|0.11|TWO_SIDED|95.0|0.32|1.12|||negative-binomial regression|||||1.12|0.32|=0.11
71786312|NCT04786990|143071088|OTHER|||||||0.0005||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0005
71786313|NCT04786990|143071089|OTHER|||||||0.0016||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0016
71786314|NCT04786990|143071090|OTHER|||||||0.89||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.8900
71786315|NCT04786990|143071091|OTHER|||||||0.3269||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3269
71669761|NCT01998919|142856930|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
71753763|NCT03413891|143010523|SUPERIORITY||Rate Ratio|0.42|||=|0.15|TWO_SIDED|95.0|0.13|1.38|||negative-binomial regression|||||1.38|0.13|=0.15
71753764|NCT03413891|143010525|SUPERIORITY||Rate Ratio|0.57|||=|0.37|TWO_SIDED|95.0|0.17|1.91|||negative-binomial regression|||||1.91|0.17|=0.37
71753765|NCT03413891|143010526|SUPERIORITY||Risk Ratio (RR)|0.7|||=|0.66|TWO_SIDED|95.0|0.26|1.91|||Chi-squared|||||1.91|0.26|=0.66
71786316|NCT04786990|143071092|OTHER|||||||0.5085||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5085
71786317|NCT04786990|143071093|OTHER|||||||0.3484||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.3484
71669762|NCT01998919|142856930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.33|0.68|||Wald test|||||0.68|0.33|<0.0001
71669763|NCT01998919|142856931|SUPERIORITY_OR_OTHER|||||||0.5991|||||||Log Rank|||||||0.5991
71669764|NCT01998919|142856931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3774|TWO_SIDED|95.0|0.58|1.23|||Wald test|||||1.23|0.58|0.3774
71753766|NCT03413891|143010527|SUPERIORITY||Rate Ratio|0.4|||=|0.04|TWO_SIDED|95.0|0.16|0.98|||negative-binomial regression|||||0.98|0.16|=0.04
71753767|NCT03413891|143010528|SUPERIORITY||Rate Ratio|0.37|||<|0.01|TWO_SIDED|95.0|0.18|0.78|||negative-binomial regression|||||0.78|0.18|<0.01
71753768|NCT04905134|143010554|OTHER|||||||0.04|||||||Fisher Exact|||Flexible scope compared with the SOC scope||||0.04
71753769|NCT02234843|143010623|OTHER||Hazard Ratio (HR)|0.4||||0.1509|TWO_SIDED|95.0|0.11|1.41|||Expl. Cox Proportional Hazards Model|||||1.41|0.11|0.1509
71753770|NCT03905096|143010658|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|92.63|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|85.34|100.53|||ANOVA|"The statistical model was analysis of variance (ANOVA) on the logarithmic scale considering the effects subjects as random and treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||100.53|85.34|
71753771|NCT03905096|143010659|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.64|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|93.21|104.39|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||104.39|93.21|
71669765|NCT00897715|142856935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.||||0.03
71669766|NCT00897715|142856936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||0.05 is the a priori threshold for statistical significance|ANCOVA|||||||0.01
71669767|NCT02321111|142856937|OTHER|ANOVA||||||0.02|||||||ANOVA|||||||0.02
71669768|NCT02550561|142856956|SUPERIORITY|||||||0.317||||||Subjects that reported either moderately or markedly improved on the GRA scale at 6 weeks compared to 12 weeks.|McNemar|||||||0.317
71669769|NCT02550561|142856957|OTHER|||||||0.47|||||||paired t-tests|||The mean change in Visual Analog Scale (VAS) score for bladder pain||||0.47
71753772|NCT03905096|143010660|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|98.48|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|90.74|106.88|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||106.88|90.74|
71669770|NCT02550561|142856957|OTHER|||||||0.17|||||||paired t-test|||The mean change in Pelvis Pain and Urgency/Frequency Patient Symptom (PUF) score||||0.17
71669771|NCT02550561|142856957|OTHER|||||||0.08|||||||paired t-test|||The mean change for O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)||||.08
71786318|NCT04786990|143071094|OTHER|||||||0.4385||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.4385
71786319|NCT04786990|143071095|OTHER|||||||0.5073||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.5073
71786320|NCT04786990|143071096|OTHER|||||||0.9119||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.9119
71669772|NCT02550561|142856957|OTHER|||||||0.51|||||||paired t-test|||The mean change O'Leary-Sant Interstitial Cystitis Problem Index (ICPI)||||0.51
71669773|NCT02550561|142856957|OTHER|||||||0.22|||||||paired t-test|||The mean change in 24-h urinary frequency||||0.22
71669774|NCT00791778|142856962|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.655|TWO_SIDED|95.0|0.72|1.63|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.||1.63|0.72|0.655
71669775|NCT00791778|142856963|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.951|TWO_SIDED|95.0|0.93|2.2|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|||2.20|0.93|0.951
71669776|NCT00791778|142856964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.84|TWO_SIDED|95.0|0.69|3.23|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization.|Sorafenib compared to Placebo|||3.23|0.69|0.84
71669777|NCT00235755|142856988|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
71669778|NCT00235755|142856988|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||0.007
71669779|NCT00235755|142856989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71669780|NCT00235755|142856989|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71669781|NCT01532934|142857014|SUPERIORITY_OR_OTHER|||||||0.02||||||As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.|Regression, Linear|||A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.||||.02
71753773|NCT03905096|143010661|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.15|STANDARD_DEVIATION|14.4|||TWO_SIDED|90.0|89.01|112.68|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||112.68|89.01|
71753774|NCT03905096|143010662|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|94.77|STANDARD_DEVIATION|10.6|||TWO_SIDED|90.0|88.36|101.64|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||101.64|88.36|
71753775|NCT03905096|143010663|OTHER|Relative bioavailability|Ratio of the geometric means (T/R) %|100.06|STANDARD_DEVIATION|6.9|||TWO_SIDED|90.0|94.56|105.87|||ANOVA|"The statistical model was ANOVA on the logarithmic scale considering the effect subjects as random and the effect treatment as fixed."|The standard deviation is actually the geometric coefficient of variation (gCV) T=Test, R=Reference|||105.87|94.56|
71753776|NCT02016781|143010664|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|Wald test of difference in adjusted OS estimates.||The null hypothesis is that the rates of three-year OS are the same for both treatments. The results posted are from the interim analysis per protocol study design.||||0.0001
71753777|NCT02016781|143010664|SUPERIORITY|||||||0.3345||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between response to hypomethylating therapy and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of response to hypomethylating therapy (No Response to Hypomethylation vs. Any Response or Hematologic Improvement to Hypomethylation vs. No Prior Hypomethylation) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3345
71753778|NCT02016781|143010664|SUPERIORITY|||||||0.7328||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between patient age and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of patient age (\< vs. \>= 65) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.7328
71753779|NCT02016781|143010664|SUPERIORITY|||||||0.6261||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between disease duration and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.6261
71753780|NCT02016781|143010664|SUPERIORITY|||||||0.4134||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS score and treatment assignment in regression model.||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4134
71753781|NCT02016781|143010664|SUPERIORITY|||||||0.3147||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|Overall Wald test of interaction terms between IPSS-R score and treatment assignment in regression model.||Statistical Analysis 6: This subgroup analysis investigated the differential impact of IPSS-R score (Very Low, Low, or Intermediate vs. High vs. Very High) on the treatment effect for OS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.3147
71753782|NCT02016781|143010665|SUPERIORITY|||||||0.003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments.||||0.0030
71753783|NCT02016781|143010665|SUPERIORITY|||||||0.9908||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of response to hypomethylating therapy on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.9908
71753784|NCT02016781|143010665|SUPERIORITY|||||||0.8981||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of patient age (\< or \>= 65) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.8981
71669782|NCT01532934|142857015|SUPERIORITY_OR_OTHER|||||||0.34||||||As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p\<.05.|Regression, Linear|||Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.||||.34
71753785|NCT02016781|143010665|SUPERIORITY|||||||0.1465||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of disease duration (less than vs. 3 months or more) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.1465
71786321|NCT04786990|143071097|OTHER|||||||0.014||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0140
71786322|NCT04786990|143071098|OTHER|||||||0.1542||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.1542
71786323|NCT04786990|143071099|OTHER|||||||0.0086||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4 versus Week 8||||0.0086
71786324|NCT04786990|143071100|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71786325|NCT04786990|143071100|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71891892|NCT03193866|143305377|SUPERIORITY||Difference in proportion|3.9|||||TWO_SIDED|95.0|-6.3|14.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||14.1|-6.3|
71891893|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-34.1|||||TWO_SIDED|95.0|-40.3|-27.9||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.9|-40.3|
71753786|NCT02016781|143010665|SUPERIORITY|Statistical significance was determined using a pre-specified threshold of 0.05.||||||0.4991|||||||pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS score (Intermediate-2 vs. High) on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4991
71891894|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-32.2|||||TWO_SIDED|95.0|-43.0|-21.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-21.5|-43.0|
71891895|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-21.8|||||TWO_SIDED|95.0|-27.9|-15.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-15.7|-27.9|
71891896|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-7.8|||||TWO_SIDED|95.0|-14.5|-1.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.2|-14.5|
71891897|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-23.6|||||TWO_SIDED|95.0|-28.9|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-28.9|
71891898|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-12.7|||||TWO_SIDED|95.0|-18.9|-6.5||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.5|-18.9|
71891899|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-26.5|||||TWO_SIDED|95.0|-32.8|-20.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.2|-32.8|
71891900|NCT03193866|143305378|SUPERIORITY||Difference in proportion|-31.7|||||TWO_SIDED|95.0|-40.1|-23.2||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-23.2|-40.1|
71669783|NCT01532934|142857016|SUPERIORITY_OR_OTHER|||||||0.69||||||a priori threshold p\<.05|Regression, Logistic|||Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.||||.69
71753787|NCT02016781|143010665|SUPERIORITY|||||||0.4953||||||Statistical significance was determined using a pre-specified threshold of 0.05.|pseudo-value regression models|||This subgroup analysis investigated the differential impact of IPSS-R score on the treatment effect for LFS at three years post-consent for the HCT arm vs. the non-HCT arm. The analysis was conducted using pseudo-value regression models via an interaction term between the factor and the treatment group with a logit link function.||||0.4953
71753788|NCT02016781|143010666|SUPERIORITY|||||||0.2777||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the FACT-G scores are the same at Enrollment for both treatments.||||0.2777
71669784|NCT02291237|142857020|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.55||||0.416|TWO_SIDED|95.0|-1.87|0.78|||ANCOVA|P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.||The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).||0.78|-1.87|0.416
71669785|NCT02291237|142857021|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.42||||0.517|TWO_SIDED|95.0|-1.68|0.85||P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.|ANCOVA|||The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).||0.85|-1.68|0.517
71669786|NCT02291237|142857022|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|1.54||||0.513|TWO_SIDED|95.0|-3.11|6.19|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||6.19|-3.11|0.513
71669787|NCT02291237|142857023|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.1||||0.964|TWO_SIDED|95.0|-4.36|4.56|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||4.56|-4.36|0.964
71669788|NCT02291237|142857024|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|-0.04||||0.944|TWO_SIDED|95.0|-1.18|1.1|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||1.10|-1.18|0.944
71669789|NCT02291237|142857025|SUPERIORITY||LS Mean Difference(Eleclazine - Placebo)|0.0||||0.993|TWO_SIDED|95.0|-0.96|0.97|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).||0.97|-0.96|0.993
71669790|NCT00699998|142857054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.915||||0.21|TWO_SIDED|95.0|0.793|1.055||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.055|0.793|0.210
71753789|NCT02016781|143010666|SUPERIORITY|||||||0.225||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 6 Months for both treatments.||||0.2250
71753790|NCT02016781|143010666|SUPERIORITY|||||||0.1048||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 12 Months for both treatments.||||0.1048
71753791|NCT02016781|143010666|SUPERIORITY|||||||0.0888||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 18 Months for both treatments.||||0.0888
71753792|NCT02016781|143010666|SUPERIORITY|||||||0.5844||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 24 Months for both treatments.||||0.5844
71669791|NCT00699998|142857054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.731|TWO_SIDED|95.0|0.865|1.225||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.225|0.865|0.731
71753793|NCT02016781|143010666|SUPERIORITY|||||||0.0344||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in FACT-G scores from enrollment are the same at 36 Months for both treatments.||||0.0344
71786326|NCT04786990|143071101|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 4||||<0.0001
71786327|NCT04786990|143071101|OTHER||||||<|0.0001||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||Week 8||||<0.0001
71786328|NCT04786990|143071102|OTHER|||||||0.5582||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 4; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5582
71669792|NCT00699998|142857055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.388|TWO_SIDED|95.0|0.812|1.088|||Log Rank|Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.088|0.812|0.388
71753794|NCT02016781|143010667|SUPERIORITY|||||||0.5583||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 PCS scores are the same at Enrollment for both treatments.||||0.5583
71753795|NCT02016781|143010667|SUPERIORITY|||||||0.669||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 6 Months for both treatments.||||0.6690
71753796|NCT02016781|143010667|SUPERIORITY|||||||0.2089||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 12 Months for both treatments.||||0.2089
71753797|NCT02016781|143010667|SUPERIORITY|||||||0.4343||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 18 Months for both treatments.||||0.4343
71753798|NCT02016781|143010667|SUPERIORITY|||||||0.5942||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 24 Months for both treatments.||||0.5942
71786329|NCT04786990|143071103|OTHER|||||||0.5061||||||The p-value generated from the statistical test for this efficacy measure is considered nominal. An adjustment for multiplicity was not performed, and as a result, there is no control of Type 1 error in the statistical analysis of these data.|t-test, 2 sided|||"Week 8; Morning PR-ADHD-RS-5 Total score versus Evening PR-ADHD-RS-5 Total score"||||0.5061
71786330|NCT00923247|143071115|SUPERIORITY_OR_OTHER|||||||0.019|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).||||0.019
71836578|NCT03761537|143179155|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.1||||0.014|TWO_SIDED|95.0|2.9|25.3||This endpoint was the sixth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.3|2.9|0.014
71836579|NCT03761537|143179156|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|7.3||||0.228|TWO_SIDED|95.0|-4.6|19.2||This endpoint was the seventh endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|HaenszMantelel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||19.2|-4.6|0.228
71669793|NCT00699998|142857055|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.99|TWO_SIDED|95.0|0.833|1.195||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.195|0.833|0.990
71753799|NCT02016781|143010667|SUPERIORITY|||||||0.1615||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 PCS scores from enrollment are the same at 36 Months for both treatments.||||0.1615
71753800|NCT02016781|143010667|SUPERIORITY|||||||0.5659||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the MOS SF-36 MCS scores are the same at Enrollment for both treatments.||||0.5659
71753801|NCT02016781|143010667|SUPERIORITY|||||||0.8555||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 6 Months for both treatments.||||0.8555
71753802|NCT02016781|143010667|SUPERIORITY|||||||0.8995||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 12 Months for both treatments.||||0.8995
71753803|NCT02016781|143010667|SUPERIORITY|||||||0.0105||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 18 Months for both treatments.||||0.0105
71753804|NCT02016781|143010667|SUPERIORITY|||||||0.2596||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 24 Months for both treatments.||||0.2596
71753805|NCT02016781|143010667|SUPERIORITY|||||||0.5022||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in MOS SF-36 MCS scores from enrollment are the same at 36 Months for both treatments.||||0.5022
71753806|NCT02016781|143010668|SUPERIORITY|||||||0.1768||||||Statistical significance was determined using a pre-specified threshold of 0.05.|t-test, 2 sided|||The null hypothesis is that the EQ-5D scores are the same at Enrollment for both treatments.||||0.1768
71753807|NCT02016781|143010668|SUPERIORITY|||||||0.8318||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 6 Months for both treatments.||||0.8318
71753808|NCT02016781|143010668|SUPERIORITY|||||||0.4752||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 12 Months for both treatments.||||0.4752
71753809|NCT02016781|143010668|SUPERIORITY|||||||0.5671||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 18 Months for both treatments.||||0.5671
71753810|NCT02016781|143010668|SUPERIORITY|||||||0.3009||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 24 Months for both treatments.||||0.3009
71753811|NCT02016781|143010668|SUPERIORITY|||||||0.3403||||||Statistical significance was determined using a pre-specified threshold of 0.05.|ANOVA|Changes in scores from enrollment were compared between arms using ANOVA models with treatment arm as main effect and enrollment score as a covariate||The null hypothesis is that the changes in EQ-5D scores from enrollment are the same at 36 Months for both treatments.||||0.3403
71753812|NCT02016781|143010669|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year OS are the same for both treatments in treated population.||||< 0.0001
71753813|NCT02016781|143010670|SUPERIORITY||||||<|0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wald test|||The null hypothesis is that the rates of three-year LFS are the same for both treatments in treated population.||||< 0.0001
71753814|NCT03563209|143010688|OTHER||||||<|0.001||||||p-value was adjusted for multiple comparisons. A priori threshold for statistical significance was set to 0.05/3 (0.0167)|Friedman|||Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)||||<0.001
71753815|NCT01488045|143010769|EQUIVALENCE|We compared patient satisfaction for those receiving the 2 sedation regimens using the Schuirmann 2 one-sided t test procedure.15 The groups were declared to be equivalent in terms of patient satisfaction if the 90% CI for the difference in mean satisfaction had outer boundaries indicating \<5% difference on the 100-point VAS. Nonequivalence was declared if the lower 90% CI boundary for the difference was less than -5.0, or if the upper 90% CI boundary for the difference was \>5.0.|Mean Difference (Final Values)|-14.0741|STANDARD_DEVIATION|22.2|||TWO_SIDED|95.0|-18.5|-9.6||||||To calculate the required sample size for this study, the equivalence limit was set at 5 units difference on the VAS, with an expected mean difference of 0. The common SD of 16.2 was estimated based on the range of expected scores for the VAS from Ulmer et al. Using these inputs, a total sample size of 262 patients was estimated to have 80% power to reject the null hypothesis that the test and standard were not equivalent and conclude that they were equivalent.||-9.6|-18.5|
71753816|NCT00989911|143010775|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71753817|NCT02212015|143010782|OTHER||Rate|0.46|||||TWO_SIDED|||||||||Question is, if 6 months progression free survival rate (PFS-R) denoted by pPFS is higher than 35%. Test hypothesis is thus formulated as: H0: pPFS ≤0.35 versus H1: pPFS ≥0.35. This hypothesis is tested at the one-side significance level of 0.05. A 6 months PFS-R of 0.55 of cases or more is considered as clinically relevant success rate. The design is chosen such that rates of 0.55 or higher can be detected with a power of at least 0.8.||||
71753818|NCT02212015|143010783|SUPERIORITY||Rate difference|0.486|||||TWO_SIDED|||||||||||||
71753819|NCT02212015|143010784|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|||||||||||||
71753820|NCT02212015|143010785|OTHER||Median|21.6|||||TWO_SIDED|||||||||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||
71786331|NCT00923247|143071116|SUPERIORITY_OR_OTHER|||||||0.052|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).||||0.052
71786332|NCT00923247|143071117|SUPERIORITY_OR_OTHER|||||||0.44|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.||||0.440
71669794|NCT00699998|142857056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.353|TWO_SIDED|95.0|0.826|1.073||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.073|0.826|0.353
71786333|NCT00923247|143071118|SUPERIORITY_OR_OTHER|||||||0.016|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.||||0.016
71786334|NCT00923247|143071119|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.||||0.010
71786335|NCT01782222|143071121|SUPERIORITY_OR_OTHER||Least Square Mean|0.04|STANDARD_ERROR_OF_MEAN|1.24||0.977|TWO_SIDED|95.0|-2.42|2.5|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.50|-2.42|0.977
71786336|NCT01782222|143071121|SUPERIORITY_OR_OTHER||Least Square Mean|-0.22|STANDARD_ERROR_OF_MEAN|1.21||0.859|TWO_SIDED|95.0|-2.61|2.18|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.18|-2.61|0.859
71786337|NCT01782222|143071122|SUPERIORITY_OR_OTHER||Least Square Mean|-7.29|STANDARD_ERROR_OF_MEAN|2.53||0.005|TWO_SIDED|95.0|-12.3|-2.28|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-2.28|-12.30|0.005
71786338|NCT01782222|143071122|SUPERIORITY_OR_OTHER||Least Square Mean|-6.06|STANDARD_ERROR_OF_MEAN|2.45||0.015|TWO_SIDED|95.0|-10.9|-1.21|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.21|-10.90|0.015
71786339|NCT01782222|143071123|SUPERIORITY_OR_OTHER||Least Square Mean|-3.2|STANDARD_ERROR_OF_MEAN|2.46||0.2|TWO_SIDED|95.0|-8.17|1.76|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.76|-8.17|0.200
71786340|NCT01782222|143071123|SUPERIORITY_OR_OTHER||Least Square Mean|-3.04|STANDARD_ERROR_OF_MEAN|2.55||0.239|TWO_SIDED|95.0|-8.19|2.1|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.10|-8.19|0.239
71786341|NCT01782222|143071124|SUPERIORITY_OR_OTHER||Least Square Mean|-2.09|STANDARD_ERROR_OF_MEAN|3.23||0.519|TWO_SIDED|95.0|-8.48|4.31|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||4.31|-8.48|0.519
71669795|NCT00699998|142857056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.029||||0.719|TWO_SIDED|95.0|0.869|1.218||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.218|0.869|0.719
71786342|NCT01782222|143071124|SUPERIORITY_OR_OTHER||Least Square Mean|-5.06|STANDARD_ERROR_OF_MEAN|3.15||0.111|TWO_SIDED|95.0|-11.29|1.17|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||1.17|-11.29|0.111
71786343|NCT01782222|143071125|SUPERIORITY_OR_OTHER||Least Square Mean|-3.62|STANDARD_ERROR_OF_MEAN|1.9||0.06|TWO_SIDED|95.0|-7.39|0.15|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||0.15|-7.39|0.060
71786344|NCT01782222|143071125|SUPERIORITY_OR_OTHER||Least Square Mean|-3.88|STANDARD_ERROR_OF_MEAN|1.8||0.034|TWO_SIDED|95.0|-7.46|-0.3|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||-0.30|-7.46|0.034
71786345|NCT01782222|143071126|SUPERIORITY_OR_OTHER||Least Square Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.334|TWO_SIDED|95.0|-1.16|0.4|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.40|-1.16|0.334
71786346|NCT01782222|143071126|SUPERIORITY_OR_OTHER||Least Square Mean|0.02|STANDARD_ERROR_OF_MEAN|0.38||0.968|TWO_SIDED|95.0|-0.74|0.77|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||0.77|-0.74|0.968
71786347|NCT01782222|143071127|SUPERIORITY_OR_OTHER||Least Square Mean|0.16|STANDARD_ERROR_OF_MEAN|1.26||0.899|TWO_SIDED|95.0|-2.34|2.66|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||2.66|-2.34|0.899
71786348|NCT01782222|143071127|SUPERIORITY_OR_OTHER||Least Square Mean|-0.33|STANDARD_ERROR_OF_MEAN|1.19||0.785|TWO_SIDED|95.0|-2.68|2.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.||||2.03|-2.68|0.785
71786349|NCT01782222|143071128|SUPERIORITY_OR_OTHER||Least Square Mean|-4.96|STANDARD_ERROR_OF_MEAN|1.99||0.014|TWO_SIDED|95.0|-8.91|-1.01|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.01|-8.91|0.014
71786350|NCT01782222|143071128|SUPERIORITY_OR_OTHER||Least Square Mean|-4.83|STANDARD_ERROR_OF_MEAN|1.92||0.013|TWO_SIDED|95.0|-8.63|-1.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.||||-1.03|-8.63|0.013
71669796|NCT00699998|142857057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.27|TWO_SIDED|95.0|0.81|1.063||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.063|0.810|0.270
71753821|NCT02212015|143010786|SUPERIORITY|||||||0.752|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 1 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.752
71786351|NCT01209260|143071157|SUPERIORITY_OR_OTHER|||||||0.005||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|t-test, 2 sided|||Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.||||0.005
71786352|NCT01209260|143071159|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05|Chi-squared|||||||<0.001
71786353|NCT01209260|143071160|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p\<0.05.|Chi-squared|||||||<0.001
71786354|NCT01179568|143071182|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|0.82|1.81|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)||1.81|0.82|<0.05
71786355|NCT01179568|143071182|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||<|0.05|TWO_SIDED|95.0|0.88|1.17|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.||1.17|0.88|<0.05
71786356|NCT01179568|143071182|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||<|0.05|TWO_SIDED|95.0|1.0|1.46|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) \& race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.||1.46|1|<0.05
71786357|NCT01179568|143071183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.04||0.74|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||0.74
71669797|NCT00699998|142857057|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017||||0.831|TWO_SIDED|95.0|0.862|1.2||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.|||1.200|0.862|0.831
71786358|NCT01179568|143071184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|1.98||0.53|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.53
71786359|NCT01179568|143071184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.37|STANDARD_ERROR_OF_MEAN|2.08|<|0.001|TWO_SIDED|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||<.001
71786360|NCT01179568|143071185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|1.57||0.59|TWO_SIDED|||||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear|||||||.59
71786361|NCT01179568|143071186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.44||0.4|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.40
71786362|NCT01179568|143071186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|1.46||0.005|TWO_SIDED||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, \& race/ethnicity, and with inverse probability weighting to adjust for missing assessments.||||.005
71786363|NCT00646776|143071188|SUPERIORITY_OR_OTHER||Point Estimate|1.477|||||TWO_SIDED|90.0|1.188|1.835|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.835|1.188|
71786364|NCT00646776|143071189|SUPERIORITY_OR_OTHER||Point Estimate|2.489|||||TWO_SIDED|90.0|2.025|3.06|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||3.060|2.025|
71753822|NCT02212015|143010787|SUPERIORITY|||||||0.621|||||||Log Rank|||"The analysis of secondary endpoints is of descriptive nature and generally consists of summary statistics and interval estimation.~Overall survival (OS) for subgroup 2 was defined as the time of start of treatment until death (event status=1) or last contact (censoring, event status=0). OS was analyzed using Kaplan-Meier curves. Median survival time is provided alonsgside two-sided 95% confidence interval (CI), if possible."||||0.621
71753823|NCT02212015|143010788|OTHER||||||||||||||||||Frequency of each category is given|||
71669798|NCT00699998|142857058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.208|||<|0.001|TWO_SIDED|95.0|-107.872|-92.545||p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for Day 30 comparison|||-92.545|-107.872|<0.001
71669799|NCT00699998|142857058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-104.475|||<|0.001|TWO_SIDED|95.0|-115.383|-93.566||p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for 12 month comparison.|||-93.566|-115.383|<0.001
71669800|NCT00699998|142857058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.413|||<|0.001|TWO_SIDED|95.0|-63.718|-33.108||p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 30 day comparison.|||-33.108|-63.718|<0.001
71669801|NCT00699998|142857058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.264|||<|0.001|TWO_SIDED|95.0|-69.061|-23.468||p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 12 month comparison.|||-23.468|-69.061|<0.001
71669802|NCT00699998|142857059|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|0.982||||0.631|TWO_SIDED|95.0|0.91|1.059||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.059|0.910|0.631
71669803|NCT00699998|142857059|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.01||||0.844|TWO_SIDED|95.0|0.916|1.113||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.113|0.916|0.844
71753824|NCT02212015|143010789|SUPERIORITY|||||||0.349|||||||Chi squared test, exact|||Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies. Categories of BOR are CR, PR, SD, PD and NE)|Response Rate (RR) is given as Best Overall Response (BOR) and given be absolute and relative frequencies applied to the total of 26 enrolled subjects.. Categories of BOR are CR, PR, SD, PD and NE).|||0.349
71753825|NCT02212015|143010790|SUPERIORITY|||||||0.385|||||||Chi squared test, exact|||||||0.385
71753826|NCT03448406|143010806|SUPERIORITY||Median difference (HL-estimate)|4.0||||0.366|TWO_SIDED|95.0|-5.0|13.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||13.0|-5.0|0.3660
71786365|NCT00646776|143071190|SUPERIORITY_OR_OTHER||Point Estimate|1.402|||||TWO_SIDED|90.0|1.052|1.867|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||1.867|1.052|
71786366|NCT00646776|143071191|SUPERIORITY_OR_OTHER||Point Estimate|0.947|||||TWO_SIDED|90.0|0.817|1.098|||ANOVA|||||1.098|0.817|
71786367|NCT00646776|143071192|SUPERIORITY_OR_OTHER||Point Estimate|0.745||||0.0963|TWO_SIDED|90.0|0.5569|0.9967|||ANOVA|||||0.9967|0.5569|0.0963
71669804|NCT00699998|142857059|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.138||||0.098|TWO_SIDED|95.0|0.977|1.325||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.325|0.977|0.098
71669805|NCT00699998|142857059|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.066||||0.545|TWO_SIDED|95.0|0.867|1.31||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.310|0.867|0.545
71753827|NCT03448406|143010807|SUPERIORITY||Median difference (HL-estimate)|2.08||||0.2783|TWO_SIDED|95.0|-2.08|6.25|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||6.25|-2.08|0.2783
71753828|NCT03448406|143010808|SUPERIORITY||Median difference (HL-estimate)|-0.07||||0.5512|TWO_SIDED|95.0|-0.35|0.2|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||0.20|-0.35|0.5512
71753829|NCT03448406|143010809|SUPERIORITY||Median Difference (HL-estimate)|3.0||||0.3657|TWO_SIDED|95.0|-4.0|11.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodges-Lehmann (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of Placebo and the effect of empagliflozin.||11.0|-4.0|0.3657
71753830|NCT03448406|143010810|OTHER||Difference of adjusted mean|-0.09|STANDARD_DEVIATION|0.11||0.444|TWO_SIDED|95.0|-0.31|0.14|||Mixed Model Repeated Measure (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||0.14|-0.31|0.4440
71753831|NCT03448406|143010811|OTHER|||||||0.3924|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.3924
71753832|NCT03448406|143010812|OTHER|||||||0.4435|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.4435
71753833|NCT03448406|143010813|OTHER|||||||0.5124|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5124
71753834|NCT03448406|143010814|OTHER|||||||0.5713|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5713
71753835|NCT03448406|143010815|OTHER||Adjusted geometric mean ratio|0.95||||0.4032|TWO_SIDED|95.0|0.85|1.07|||Mixed model repeated Measure (MMRM)|Covariates: Visit-by-treatment interaction and baseline-by-visit interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|||1.07|0.85|0.4032
71786368|NCT00646776|143071193|SUPERIORITY_OR_OTHER||Point Estimate|0.857|||||TWO_SIDED|90.0|0.723|1.015|||ANOVA|||||1.015|0.723|
71786369|NCT00646776|143071196|SUPERIORITY_OR_OTHER||Point Estimate|0.66|||||TWO_SIDED|90.0|0.538|0.809|||ANOVA|||||0.809|0.538|
71786370|NCT00646776|143071197|SUPERIORITY_OR_OTHER||Point Estimate|0.651|||||TWO_SIDED|90.0|0.43|0.986|||ANOVA|||||0.986|0.430|
71836580|NCT03761537|143179157|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-8.9|||<|0.001|TWO_SIDED|95.0|-13.2|-4.6||This endpoint was the eighth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline SCORAD in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-4.6|-13.2|<0.001
71669806|NCT00699998|142857060|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.018||||0.727|TWO_SIDED|95.0|0.919|1.129||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.129|0.919|0.727
71669807|NCT00699998|142857060|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.057||||0.346|TWO_SIDED|95.0|0.942|1.187||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.187|0.942|0.346
71669808|NCT00699998|142857060|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.096||||0.458|TWO_SIDED|95.0|0.859|1.399||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.|||1.399|0.859|0.458
71669809|NCT00699998|142857060|SUPERIORITY_OR_OTHER||Geometric Ratio Estimate|1.033||||0.802|TWO_SIDED|95.0|0.803|1.329||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.|||1.329|0.803|0.802
71669810|NCT00699998|142857062|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.5
71669811|NCT00699998|142857062|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.72
71669812|NCT00699998|142857062|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.63
71669813|NCT00699998|142857062|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA|||||||0.53
71753836|NCT03405792|143010816|OTHER|||||||||||||||||We will use one-sample log-rank test to compare PFS between the triple combination arm relative to the historical control arm.|We took a look at median survival time and CI of our population and we compared it to the median PFS and CI of the historical control descriptively. There is no yielded P value.|||
71753837|NCT03405792|143010817|OTHER||||||||||||||||||Every participant (26/26; 100%) experienced an adverse event.|||
71753838|NCT03882021|143010829|OTHER||Kaplan Meier Survival Estimate|57.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|51.2|62.8|||||Kaplan-Meier estimate of freedom from recurrence after removal from AAD at one year.|||62.8|51.2|
71669814|NCT00725920|142857109|SUPERIORITY_OR_OTHER|||||||0.0076||95.0|||||t-test, 2 sided|||||||0.0076
71669815|NCT03918629|142857110|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for geometric mean ratio (GMR) was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Adjusted geometric mean ratio (GMR) was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.90|0.74|
71669816|NCT03918629|142857110|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean difference in logarithmic scale.|Toxin B||0.66|0.49|
71669817|NCT03918629|142857111|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.8|||||TWO_SIDED|95.0|-6.4|2.9|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||2.9|-6.4|
71753839|NCT03882021|143010830|OTHER|Kaplan Meier Estimate of freedom from symptomatic recurrence.|Kaplan-Meier Survival Estimate|61.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|55.8|67.1|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT recurrence after removal from AAD|||67.1|55.8|
71753840|NCT03882021|143010831|OTHER|Kaplan Meier estimate of single procedure clinical success.|Kaplan-Meier Survival Estimate|79.4|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|74.2|83.6|||||Kaplan-Meier estimate of freedom from symptomatic AF/AFL/AT without new or increased dose of Class I/III AAD at one year.|||83.6|74.2|
71753841|NCT03882021|143010832|OTHER|Kaplan Meier estimate of freedom from AF/AFL/AT|Kaplan Meier Survival Estimate|75.5|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|69.9|80.1|||||Kaplan Meier estimate of freedom from AF/AFL/AT at 12 months.|||80.1|69.9|
71753842|NCT02242942|143010844|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.22|0.51|||Log Rank||Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.51|0.22|<0.0001
71891901|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-33.2|||||TWO_SIDED|95.0|-39.4|-27.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-27.0|-39.4|
71669818|NCT03918629|142857111|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-16.8|||||TWO_SIDED|95.0|-21.3|-12.2|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-12.2|-21.3|
71786371|NCT00646776|143071198|SUPERIORITY_OR_OTHER||Point Estimate|0.696|||||TWO_SIDED|90.0|0.563|0.862|||ANOVA|||||0.862|0.563|
71786372|NCT00646776|143071204|SUPERIORITY_OR_OTHER||Point Estimate|10.902|||||TWO_SIDED|90.0|8.135|14.61|||ANOVA|||||14.610|8.135|
71786373|NCT00646776|143071205|SUPERIORITY_OR_OTHER||Point Estimate|7.766|||||TWO_SIDED|90.0|6.133|9.833|||ANCOVA|||||9.833|6.133|
71786374|NCT00646776|143071206|SUPERIORITY_OR_OTHER||Point Estimate|11.451|||||TWO_SIDED|90.0|8.147|16.095|||ANOVA|||||16.095|8.147|
71786375|NCT00646776|143071207|SUPERIORITY_OR_OTHER||Point Estimate|2.19|||||TWO_SIDED|90.0|1.783|2.691|||ANOVA||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.|||2.691|1.783|
71786376|NCT00580606|143071221|SUPERIORITY_OR_OTHER||Risk Difference (RD)|55.0|||<|0.001|TWO_SIDED|95.0|22.2|77.6||No adjustments were made to the p-value.|Barnard's Statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.||77.6|22.2|<0.001
71786377|NCT04847557|143071238|SUPERIORITY||Median Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.6|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||10.6|3.3|<0.001
71786378|NCT04847557|143071239|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.026|TWO_SIDED|95.0|0.41|0.95|||Regression, Cox|||Heart Failure Outcomes||0.95|0.41|0.026
71786379|NCT04847557|143071240|SUPERIORITY||Median Difference (Net)|18.3|||<|0.001|TWO_SIDED|95.0|9.9|26.7|||Stratified Wilcoxon|Stratified Wilcoxon test used to control for stratification factors of HF decompensation within 12 months of screening,diagnosed T2DM \& baseline BMI|The Hodges-Lehmann estimate for the median difference and 95% CIs was reported.|||26.7|9.9|<0.001
71786380|NCT04847557|143071241|SUPERIORITY||LS Mean Difference|-11.62|||<|0.001|TWO_SIDED|95.0|-12.85|-10.38|||ANCOVA|||||-10.38|-12.85|<0.001
71786381|NCT04847557|143071242|SUPERIORITY||LS Mean Difference|-34.91|||<|0.001|TWO_SIDED|95.0|-45.6|-22.17|||ANCOVA|||||-22.17|-45.60|<0.001
71786382|NCT04847557|143071243|SUPERIORITY||Win Ratio|1.63|||||TWO_SIDED|95.0|1.17|2.28|||||The win ratio was reported as the measure of treatment effect based on the principle that each participant is compared with every other participant within each stratum in a pair-wise manner that proceeds in a hierarchical fashion.|||2.28|1.17|
71786383|NCT04847557|143071244|SUPERIORITY||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.53|3.4||||||||3.40|1.53|
71786384|NCT04847557|143071245|SUPERIORITY||Hazard Ratio (HR)|1.245|||||TWO_SIDED|95.0|0.633|2.452||||||||2.452|0.633|
71786385|NCT04847557|143071246|SUPERIORITY||Hazard Ratio (HR)|0.539|||||TWO_SIDED|95.0|0.342|0.85||||||||0.850|0.342|
71786386|NCT04847557|143071247|SUPERIORITY||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.46|1.14||||||||1.14|0.46|
71786387|NCT04847557|143071248|SUPERIORITY||Rate Ratio|0.62|||||TWO_SIDED|95.0|0.37|1.05||||||||1.05|0.37|
71786388|NCT01549860|143071256|SUPERIORITY_OR_OTHER||||||<|0.024|TWO_SIDED||||||t-test, 2 sided|||||||<0.024
71786389|NCT01549860|143071258|SUPERIORITY_OR_OTHER||||||<|0.0126|TWO_SIDED|||||The MIST+SOC subjects decreased in their reported mean pain scores and reduced from a median of 3.0 to 0.6 cm after four weeks of study treatment.|ANCOVA|||||||<0.0126
71786390|NCT01327885|143071259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.768|||=|0.0169|TWO_SIDED|95.0|0.618|0.954||The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (\~353 deaths) was observed.||0.954|0.618|=0.0169
71813117|NCT03720938|143128564|SUPERIORITY|||||||0.008||||||The outcomes of auditory reaction time of non-dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.008
71753843|NCT02242942|143010845|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.23|0.53|||Log Rank||Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.|||0.53|0.23|<0.0001
71753844|NCT02242942|143010846|SUPERIORITY||Difference in Response Rates|13.43||||0.0007|TWO_SIDED|95.0|5.47|21.38||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||21.38|5.47|0.0007
71753845|NCT02242942|143010847|SUPERIORITY||Difference in Response Rates|26.39|||<|0.0001|TWO_SIDED|95.0|17.41|35.36||P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||35.36|17.41|<0.0001
71753846|NCT02242942|143010848|SUPERIORITY||Difference in MRD Negative Rates|40.28|||<|0.0001|TWO_SIDED|95.0|31.45|49.1|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||49.10|31.45|<0.0001
71836581|NCT03761537|143179158|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Difference|-1.6||||0.005|TWO_SIDED|95.0|-2.7|-0.5||This endpoint was the ninth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Repeated measurements model|Unstructured covariance matrix. Adjusted for baseline DLQI in interaction with each visit, prior CSA use, and baseline disease severity (IGA 3 or 4)||Data collected after permanent discontinuation of IMP, after initiation of rescue treatment, or after subject-onset of the COVID-19 pandemic will not be included in the analysis.||-0.5|-2.7|0.005
71669819|NCT03918629|142857120|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.87|||||TWO_SIDED|95.0|0.8|0.95|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin A||0.95|0.80|
71669820|NCT03918629|142857120|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was \>0.67 for both Toxin A and Toxin B.|Adjusted Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean or the mean difference in logarithmic scale.|Toxin B||0.81|0.62|
71669821|NCT03918629|142857121|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|1.7|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin A||1.7|-3.7|
71669822|NCT03918629|142857121|NON_INFERIORITY|The noninferiority objective was achieved if the lower limit of the 95% CI for the difference was \>-10% for both Toxin A and Toxin B.|Percentage difference|-10.3|||||TWO_SIDED|95.0|-15.1|-5.5|||||The difference (2-Dose - 3-Dose) and the associated 95% CIs for the difference were calculated using the Miettinen and Nurminen method.|Toxin B||-5.5|-15.1|
71845442|NCT03387189|143205200|SUPERIORITY|Alpha - 0.05|Odds Ratio (OR)|1.46||||0.465|TWO_SIDED|95.0|0.53|4.03|||Regression, Logistic|Adjusted for length of second stage cesarean section, fetal station, delivery method, use of instrumentation , parity, and gestational age|Y = Intervention + Time + Intervention\*Time + Covariates. Provided estimation parameter is the OR from the interaction term and can be interpreted as the differential change in odds of outcome from pre to post period associated with the intervention.|||4.03|0.53|0.465
71845443|NCT03387189|143205201|SUPERIORITY|alpha - 0.05|Mean Difference (Final Values)|-11.4||||0.01|TWO_SIDED|95.0|-20.4|-2.5|||t-test, 2 sided|||||-2.5|-20.4|0.01
71669823|NCT01891864|142857129|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.|Risk Difference (RD)|-2.3|||||TWO_SIDED|95.0|-9.85|5.3||||||PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval \[-18%; 18%\]. A logistic regression model was to be employed.||5.3|-9.85|
71669824|NCT01891864|142857130|NON_INFERIORITY_OR_EQUIVALENCE|A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.64|||||TWO_SIDED|95.0|-3.474|2.204||||||||2.204|-3.474|
71677175|NCT02989649|142872964|OTHER||Least Square Mean (LSM)|-0.87|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|-1.36|-0.39|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-0.39|-1.36|
71753847|NCT02242942|143010849|SUPERIORITY||Difference in MRD Negative Rates|39.81|||<|0.0001|TWO_SIDED|95.0|31.27|48.36|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.|||48.36|31.27|<0.0001
71753848|NCT02242942|143010851|SUPERIORITY||Difference in MRD Negative Rates|32.87|||<|0.0001|TWO_SIDED|95.0|23.76|41.98|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||41.98|23.76|<0.0001
71753849|NCT02242942|143010852|SUPERIORITY||Difference in MRD Negative Rates|38.43|||<|0.0001|TWO_SIDED|95.0|30.15|46.71|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.|||46.71|30.15|<0.0001
71845444|NCT03387189|143205202|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-1.0||||0.75|TWO_SIDED|95.0|-76.0|5.5|||t-test, 2 sided|||||5.5|-76.0|0.75
71845445|NCT03387189|143205203|SUPERIORITY|Alpha - 0.05|Mean Difference (Final Values)|-0.5||||0.02|TWO_SIDED|95.0|-1.0|-0.1|||t-test, 2 sided|||||-0.1|-1.0|0.02
71845446|NCT03387189|143205206|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.116||||0.1|TWO_SIDED|95.0|-0.01|0.24|||Fisher Exact|||||0.24|-0.01|0.10
71753850|NCT02242942|143010853|SUPERIORITY||Difference in Response Rates|1.85||||0.5612|TWO_SIDED|95.0|-4.63|8.33||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.|||8.33|-4.63|0.5612
71753851|NCT02242942|143010855|SUPERIORITY||Difference in Response Rates|0.93||||0.7169|TWO_SIDED|95.0|-4.66|6.51|||Cochran-Mantel-Haenszel|P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|95% CI for difference in rates were constructed using Anderson-Hauck method.|||6.51|-4.66|0.7169
71753852|NCT02559622|143010911|SUPERIORITY||Least Square (LS) mean difference|1.17||||0.223|TWO_SIDED|95.0|-0.72|3.06|||ANCOVA|||||3.06|-0.72|0.2230
71753853|NCT02163538|143010929|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71753854|NCT02163538|143010930|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71753855|NCT02163538|143010931|SUPERIORITY|||||||0.582|||||||Chi-squared|||||||0.582
71753856|NCT02163538|143010932|SUPERIORITY|||||||0.0031|||||||Chi-squared|||||||0.0031
71753857|NCT02163538|143010933|SUPERIORITY|||||||0.0281|||||||Wilcoxon (Mann-Whitney)|||||||0.0281
71753858|NCT02163538|143010934|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|||||||.0821
71786391|NCT01327885|143071260|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.877|||=|0.2287|TWO_SIDED|95.0|0.71|1.085||P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.085|0.710|=0.2287
71786392|NCT01327885|143071261|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3||||0.253|TWO_SIDED|95.0|0.8|1.9||The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The odds ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the odds ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified Cochran-Mantel-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.9|0.8|0.253
71786393|NCT01327885|143071262|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.9|||=|0.741|TWO_SIDED|95.0|0.7|1.4||The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.||1.4|0.7|=0.741
71845447|NCT03387189|143205208|SUPERIORITY|Alpha - 0.05|Risk Difference (RD)|0.028||||0.81|TWO_SIDED|95.0|-0.12|17.8|||Fisher Exact|||||17.8|-0.12|0.81
71677176|NCT02989649|142872965|OTHER||Least Square Mean (LSM)|-0.95|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-1.18|-0.72|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3||-0.72|-1.18|
71753859|NCT00468169|143010971|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1225||||||Log-rank test comparing PFS between two treatment arms|Log Rank|||||||0.1225
71753860|NCT01283139|143010993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.057|TWO_SIDED|90.0|1.03|2.71|||Regression, Logistic|||||2.71|1.03|0.057
71753861|NCT01283139|143010993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.094|TWO_SIDED|90.0|1.01|2.54|||Regression, Logistic|||||2.54|1.01|0.094
71753862|NCT01283139|143010993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.031|TWO_SIDED|90.0|1.16|2.94|||Regression, Logistic|||||2.94|1.16|0.031
71753863|NCT01283139|143010994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.042|TWO_SIDED|90.0|1.13|3.14|||Regression, Logistic|||||3.14|1.13|0.042
71753864|NCT01283139|143010994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.264|TWO_SIDED|90.0|0.85|2.35|||Regression, Logistic|||||2.35|0.85|0.264
71753865|NCT01283139|143010994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.038|TWO_SIDED|90.0|1.14|3.19|||Regression, Logistic|||||3.19|1.14|0.038
71753866|NCT01283139|143010995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.808|TWO_SIDED|90.0|0.37|3.81|||Regression, Logistic|||||3.81|0.37|0.808
71753867|NCT01283139|143010995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.598|TWO_SIDED|90.0|0.45|4.66|||Regression, Logistic|||||4.66|0.45|0.598
71753868|NCT01283139|143010995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.884|TWO_SIDED|90.0|0.27|3.02|||Regression, Logistic|||||3.02|0.27|0.884
71753869|NCT01283139|143010996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.044|TWO_SIDED|90.0|1.22|7.01|||Regression, Logistic|||||7.01|1.22|0.044
71753870|NCT01283139|143010996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.498|TWO_SIDED|90.0|0.62|3.19|||Regression, Logistic|||||3.19|0.62|0.498
71753871|NCT01283139|143010996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03||||0.049|TWO_SIDED|90.0|1.2|7.68|||Regression, Logistic|||||7.68|1.20|0.049
71753872|NCT01283139|143010997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.27|TWO_SIDED|90.0|0.85|2.25|||Regression, Logistic|||||2.25|0.85|0.270
71753873|NCT01283139|143010997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.077|TWO_SIDED|90.0|1.04|2.74|||Regression, Logistic|||||2.74|1.04|0.077
71753874|NCT01283139|143010997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.453|TWO_SIDED|90.0|0.76|2.05|||Regression, Logistic|||||2.05|0.76|0.453
71753875|NCT00627393|143011003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.2|||Regression, Logistic|Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|||3.20|0.44|0.73
71669825|NCT01891864|142857130|NON_INFERIORITY_OR_EQUIVALENCE|The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval \[-15%; 15%\].|Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-3.61|1.845||||||||1.845|-3.61|
71669826|NCT02892331|142857140|SUPERIORITY|||||||0.006||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and the HIGH-INT group||||0.006
71669827|NCT02892331|142857140|SUPERIORITY|||||||0.045||||||VO2 testing was not performed for one participant in the HIGH-INT group.|ANCOVA|||Comparison between the CON and MOD-INT group||||0.045
71669828|NCT02892331|142857140|SUPERIORITY|VO2 testing was not performed for one participant in the HIGH-INT group.||||||0.449|||||||ANCOVA|||Comparison between MOD-INT and High-INT groups||||0.449
71669829|NCT02892331|142857141|SUPERIORITY|||||||0.276|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.276
71669830|NCT02892331|142857141|SUPERIORITY|||||||0.633|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.633
71669831|NCT02892331|142857141|SUPERIORITY|||||||0.555|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.555
71753876|NCT00627393|143011006|SUPERIORITY_OR_OTHER||Log Rank P-Value|0.43||||0.43|TWO_SIDED|||||Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).|Competing Risks|||||||0.43
71753877|NCT00627393|143011011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.293|STANDARD_ERROR_OF_MEAN|0.25885||0.35|TWO_SIDED|95.0|0.778|2.147|||Log Rank|Log-rank test to compare survival distributions between the control group and treatment group.|The control group is considered the reference group.|||2.147|0.778|0.35
71845448|NCT03387189|143205209|SUPERIORITY|Alpha - 0.05|Risk Ratio (RR)|0.01||||1|TWO_SIDED|95.0|-0.11|0.13|||Fisher Exact|||||0.13|-0.11|1.0
71669832|NCT02892331|142857142|SUPERIORITY|||||||0.37|||||||ANCOVA|||Comparison between the CON group and the HIGH-INT group||||0.370
71669833|NCT02892331|142857142|SUPERIORITY|||||||0.383|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.383
71669834|NCT02892331|142857142|SUPERIORITY|||||||0.0972|||||||ANCOVA|||Comparison for the MOD-INT and HIGH-INT groups||||0.0972
71669835|NCT02892331|142857143|SUPERIORITY|||||||0.932|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.932
71669836|NCT02892331|142857143|SUPERIORITY|||||||0.307|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.307
71669837|NCT02892331|142857143|SUPERIORITY|||||||0.376|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.376
71669838|NCT02892331|142857144|SUPERIORITY|||||||0.136|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.136
71669839|NCT02892331|142857144|SUPERIORITY|||||||0.262|||||||ANCOVA|||Comparison between the CON and the MOD-INT group||||0.262
71669840|NCT02892331|142857144|SUPERIORITY|||||||0.715|||||||ANCOVA|||Comparison between the MOD-INT group and the HIGH-INT groups||||0.715
71669841|NCT02892331|142857145|SUPERIORITY|||||||0.056|||||||ANCOVA|||Comparison between the CON and High-INT groups||||0.056
71669842|NCT02892331|142857145|SUPERIORITY|||||||0.349|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.349
71669843|NCT02892331|142857145|SUPERIORITY|||||||0.359|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.359
71669844|NCT02892331|142857146|SUPERIORITY|||||||0.224|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.224
71669845|NCT02892331|142857146|SUPERIORITY|||||||0.199|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.199
71669846|NCT02892331|142857146|SUPERIORITY|||||||0.952|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.952
71669847|NCT02892331|142857147|SUPERIORITY|||||||0.783|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.783
71669848|NCT02892331|142857147|SUPERIORITY|||||||0.098|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.098
71669849|NCT02892331|142857147|SUPERIORITY|||||||0.071|||||||ANCOVA|||Comparison between the MOD and HIGH-INT groups||||0.071
71669850|NCT02892331|142857148|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the CON and the HIGH-INT groups||||0.940
71669851|NCT02892331|142857148|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the CON and MOD-INT groups||||0.994
71669852|NCT02892331|142857148|SUPERIORITY|||||||0.94|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.940
71669853|NCT02892331|142857149|SUPERIORITY|||||||0.769|||||||ANCOVA|||Comparison of the CON and HIGH-INT groups||||0.769
71669854|NCT02892331|142857149|SUPERIORITY|||||||0.8|||||||ANCOVA|||Comparison of the CON and MOD-INT groups||||0.800
71669855|NCT02892331|142857149|SUPERIORITY|||||||0.769|||||||ANCOVA|||||||0.769
71669856|NCT02892331|142857150|SUPERIORITY|||||||1|||||||ANCOVA|||Comparison between the CON and the MOD groups||||1.000
71669857|NCT02892331|142857150|SUPERIORITY|||||||0.993|||||||ANCOVA|||Comparison of HIGH-INT and CON groups||||0.993
71669858|NCT02892331|142857150|SUPERIORITY|||||||0.994|||||||ANCOVA|||Comparison between the MOD-INT and the HIGH-INT groups||||0.994
71669859|NCT02892331|142857151|SUPERIORITY|||||||0.821|||||||ANCOVA|||Change in insulin sensitivity (CON vs. HIGH-INT)||||0.821
71669860|NCT02892331|142857151|SUPERIORITY|||||||0.985|||||||ANCOVA|||Change in insulin sensitivity (CON vs. MOD-INT)||||0.985
71669861|NCT02892331|142857151|SUPERIORITY|||||||0.856|||||||ANCOVA|||Change in insulin sensitivity (MOD-INT vs. HIGH-INT)||||0.856
71669862|NCT02892331|142857152|SUPERIORITY|||||||0.093|||||||ANCOVA|||Comparison between the CON and HIGH-INT groups||||0.093
71669863|NCT02892331|142857152|SUPERIORITY|||||||0.033|||||||ANCOVA|||Comparison between the CON and the MOD-INT groups||||0.033
71669864|NCT02892331|142857152|SUPERIORITY|||||||0.602|||||||ANCOVA|||Comparison between the MOD-INT and HIGH-INT groups||||0.602
71669865|NCT02892331|142857153|SUPERIORITY|||||||0.424|||||||ANCOVA|||Change in PGC1A (CON vs. HIGH-INT)||||0.424
71813118|NCT03720938|143128564|SUPERIORITY|||||||0.006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006
71845449|NCT00291694|143205216|SUPERIORITY_OR_OTHER|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
71753878|NCT00784563|143011040|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.|Regression, Linear|||Sample size was estimated using 80% power to detect an effect size of 0.66 SD in VO2max (estimated improvement=10% /estimated SD of change=15%) within each arm at alpha=0.05 and an attrition rate of 25%.||||<0.001
71753879|NCT00784563|143011041|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71753880|NCT00784563|143011042|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Regression, Linear|||||||0.029
71753881|NCT00784563|143011043|SUPERIORITY_OR_OTHER|||||||0.271|TWO_SIDED||||||Regression, Linear|||||||0.271
71753882|NCT00784563|143011044|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||unadjusted p-value=0.009|Regression, Linear|||||||0.070
71753883|NCT00784563|143011045|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71786394|NCT02692703|143071297|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.|Percentage of Participants|98.0|||||TWO_SIDED|95.0|95.3|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides \>90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|95.3|
71786395|NCT01979016|143071343|SUPERIORITY||Least Squares (LS) Mean Difference|-69.4|||<|0.0001|TWO_SIDED|95.0|-92.5|-46.2|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a mixed model repeated measures (MMRM) model.||-46.2|-92.5|< 0.0001
71836582|NCT03761537|143179159|SUPERIORITY|The null hypothesis of no difference between Tralokinumab+TCS and placebo+TCS was tested at a 5% significance level against the 2-sided alternative that there was a difference.|Risk Difference (RD)|14.3||||0.014|TWO_SIDED|95.0|2.9|25.6||This endpoint was the tenth endpoint in the sequential testing hierarchy. Acceptance of this endpoint depends on prior endpoints' acceptance.|Mantel Haenszel|Mantel-Haenszel (MH) test stratified by prior CSA use and baseline disease severity. MH risk differences and standard errors combined by Rubin's rule.||Subjects who received rescue treatment or permanently discontinued IMP, without prior subject-onset of the COVID-19 pandemic (SOC19), were considered non-responders after the relevant event occurred. Any data from subjects who had SOC19 as their first prior intercurrent event (ICE) were multiple imputed (MI) assuming missing at random (MAR) following start of SOC19. Data missing prior to any ICE were handled as non-response, except data missing due to the pandemic, which was MI assuming MAR.||25.6|2.9|0.014
71786396|NCT01979016|143071344|SUPERIORITY||Percentage difference|37.0|||=|0.0006|TWO_SIDED|95.0|18.82|55.25|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||55.25|18.82|= 0.0006
71786397|NCT01979016|143071345|SUPERIORITY||Percentage difference|48.1|||<|0.0001|TWO_SIDED|95.0|28.0|68.3|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||68.30|28.00|< 0.0001
71786398|NCT01979016|143071346|SUPERIORITY||LS Mean Difference|-2.66|||<|0.0001|TWO_SIDED|95.0|-3.8|-1.52|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-1.52|-3.80|< 0.0001
71669866|NCT02892331|142857153|SUPERIORITY|||||||0.308|||||||ANCOVA|||Change in PGC1A (CON vs. MOD-INT)||||0.308
71786399|NCT01979016|143071347|SUPERIORITY||LS Mean Difference|-48.08|||=|0.0001|TWO_SIDED|95.0|-71.31|-24.85|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-24.85|-71.31|= 0.0001
71786400|NCT01979016|143071348|SUPERIORITY||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-29.0|-14.0|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-14.0|-29.0|<0.0001
71845450|NCT00291694|143205217|SUPERIORITY_OR_OTHER|||||||0.053||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Difference between groups, two-sided. Endpoint not specifically powered for effect.||||0.053
71669867|NCT02892331|142857153|SUPERIORITY|||||||0.844|||||||ANCOVA|||Change in PGC1a (MOD-INT vs. HIGH-INT)||||0.844
71669868|NCT02892331|142857153|SUPERIORITY|||||||0.135|||||||ANCOVA|||Change in citrate synthase (CON vs. HIGH-INT)||||0.135
71753884|NCT00784563|143011046|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Regression, Linear|||||||0.006
71753885|NCT00784563|143011047|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
71753886|NCT00784563|143011048|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Regression, Linear|Adjusted for change in total daily equivalent levodopa dose||||||0.003
71753887|NCT00784563|143011049|SUPERIORITY_OR_OTHER||||||=|0.146|TWO_SIDED||||||t-test, 2 sided|||||||=0.146
71753888|NCT00784563|143011050|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||0.037
71753889|NCT00784563|143011051|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.057
71753890|NCT01614249|143011052|SUPERIORITY_OR_OTHER||Slope|1.01|STANDARD_ERROR_OF_MEAN|0.8||0.21|TWO_SIDED|95.0|-0.58|2.6||The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.|ANCOVA|In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.||Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV-seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.||2.60|-0.58|0.21
71753891|NCT02787564|143011277|OTHER||||||<|0.001||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||<0.001
71753892|NCT02787564|143011278|OTHER|||||||0.038||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.038
71753893|NCT02787564|143011279|OTHER|||||||0.026||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.026
71753894|NCT02787564|143011280|OTHER|||||||0.443||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.443
71753895|NCT02787564|143011281|OTHER|||||||0.006||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.006
71669869|NCT02892331|142857153|SUPERIORITY|||||||0.8|||||||ANCOVA|||Change in Citrate synthase (CON vs. MOD-INT)||||0.800
71753896|NCT02787564|143011282|OTHER|||||||0.029||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)|||||||0.029
71786401|NCT01979016|143071349|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|95.0|-41.5|-21.1|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.||-21.1|-41.5|< 0.0001
71786402|NCT01979016|143071350|SUPERIORITY||LS Mean Difference|-46.6|||<|0.0001|TWO_SIDED|95.0|-62.0|-31.3|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by MMRM model.||-31.3|-62.0|< 0.0001
71786403|NCT01979016|143071351|SUPERIORITY||Percentage difference|55.6|||<|0.0001|TWO_SIDED|95.0|33.38|77.73|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.||77.73|33.38|< 0.0001
71786404|NCT01979016|143071351|SUPERIORITY||Percentage difference|51.9|||=|0.0001|TWO_SIDED|95.0|29.59|74.12|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.||74.12|29.59|= 0.0001
71786405|NCT01979016|143071351|SUPERIORITY||Percentage difference|33.3|||=|0.0011|TWO_SIDED|95.0|15.55|51.11|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.||51.11|15.55|= 0.0011
71786406|NCT01979016|143071352|SUPERIORITY||Percentage difference|48.1|||=|0.0002|TWO_SIDED|95.0|27.0|69.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.||69.3|27.0|= 0.0002
71786407|NCT01979016|143071352|SUPERIORITY||Percentage difference|11.1|||=|0.0792|TWO_SIDED|95.0|-0.7|23.0|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.||23.0|-0.7|= 0.0792
71786408|NCT01979016|143071352|SUPERIORITY||Percentage difference|7.4|||=|0.1573|TWO_SIDED|95.0|-2.5|17.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.||17.3|-2.5|= 0.1573
71786409|NCT01979016|143071353|SUPERIORITY||LS Mean Difference|-10.4|||<|0.0001|TWO_SIDED|95.0|-14.3|-6.6|||ANCOVA|||Analysis was performed by a MMRM model.||-6.6|-14.3|< 0.0001
71786410|NCT01979016|143071354|SUPERIORITY||LS Mean Difference|-46.2|||<|0.0001|TWO_SIDED|95.0|-63.9|-28.5|||ANCOVA|||Analysis was performed by a MMRM model.||-28.5|-63.9|< 0.0001
71786411|NCT01979016|143071356|SUPERIORITY||LS Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.02|-2.39|||ANCOVA|||||-2.39|-5.02|< 0.0001
71786412|NCT03765918|143071406|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.3|||<|1e-05|TWO_SIDED|95.0|6.7|12.8||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||12.8|6.7|<0.00001
71786413|NCT03765918|143071407|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|13.7|||<|1e-05|TWO_SIDED|95.0|9.7|18.7||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||18.7|9.7|<0.00001
71669870|NCT02892331|142857153|SUPERIORITY|||||||0.195|||||||ANCOVA|||Change in citrate synthase||||0.195
71786414|NCT03765918|143071408|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|9.8|||<|1e-05|TWO_SIDED|95.0|7.0|13.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||13.3|7.0|<0.00001
71786415|NCT03765918|143071409|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.0||||0.0006|TWO_SIDED|95.0|1.5|5.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.3|1.5|0.0006
71669871|NCT02892331|142857153|SUPERIORITY|||||||0.459|||||||ANCOVA|||Change in complex I||||0.459
71669872|NCT02892331|142857153|SUPERIORITY|||||||0.213|||||||ANCOVA|||Change in complex 1 (CON vs. MOD-INT groups)||||0.213
71669873|NCT02892331|142857153|SUPERIORITY|||||||0.971|||||||ANCOVA|||Change in complex II (MOD-INT vs. HIGH-INT)||||0.971
71753897|NCT02443688|143011300|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% confidence interval (CI)|Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|95.0|-1.34|4.12|||ANOVA|||||4.12|-1.34|
71753898|NCT02443688|143011300|OTHER|Single Group Difference from Placebo Mean Change from Baseline with 95% CI|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-3.78|1.64|||ANOVA|||||1.64|-3.78|
71753899|NCT02443688|143011300|SUPERIORITY|Difference from placebo of pooled arms (100mg CTX-4430 and 50mg CTX-4430) in change from baseline in ppFEV1 at Week 48.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-2.2|2.5||0.1 alpha level (2-sided) prespecified|ANOVA|||||2.50|-2.20|0.45
71753900|NCT02443688|143011301|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.57|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.22|2.02|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.02|1.22|
71786416|NCT03765918|143071410|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|4.2||||0.0011|TWO_SIDED|95.0|2.1|7.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||7.6|2.1|0.0011
71845451|NCT00291694|143205218|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
71669874|NCT02892331|142857153|SUPERIORITY|||||||0.634|||||||ANCOVA|||Change in complex III (CON vs. HIGH-INT)||||0.634
71669875|NCT02892331|142857153|SUPERIORITY|||||||0.919|||||||ANCOVA|||Change in Complex III (CON vs. MOD-INT groups)||||0.919
71753901|NCT02443688|143011301|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.46|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|1.13|1.89|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.89|1.13|
71669876|NCT02892331|142857153|SUPERIORITY|||||||0.574|||||||ANCOVA|||Change in complex III||||0.574
71669877|NCT02892331|142857153|SUPERIORITY|||||||0.295|||||||ANCOVA|||Change in Complex IV (CON vs. HIGH-INT)||||0.295
71753902|NCT02443688|143011301|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.56|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|1.21|2.01|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.01|1.21|
71753903|NCT02443688|143011301|OTHER|Pooled Group Rate with 95% CI|see Estimation Comment below|1.51|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|1.26|1.81|||||Estimated using negative binomial distribution unadjusted for multiple comparisons.|||1.81|1.26|
71753904|NCT02443688|143011302|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.88|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.58|1.34|||Regression, Cox|||||1.34|0.58|
71753905|NCT02443688|143011302|OTHER|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.56|1.31|||Regression, Cox|||||1.31|0.56|
71753906|NCT02443688|143011302|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.61|1.25|||Regression, Cox|||||1.25|0.61|
71753907|NCT02443688|143011308|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|0.84|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.49|1.44|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.44|0.49|
71753908|NCT02443688|143011308|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.28|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|0.84|1.96|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.96|0.84|
71753909|NCT02443688|143011308|OTHER|Single Group Rate with 95% CI|see Estimation Comment below|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|1.07|2.42|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||2.42|1.07|
71753910|NCT02443688|143011308|OTHER|Group Rate with 95% CI|see Estimation Comment below|1.04|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.74|1.46|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.|||1.46|0.74|
71753911|NCT02443688|143011309|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|0.25|1.1|||Regression, Cox|||||1.10|0.25|
71753912|NCT02443688|143011309|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.62|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.3|1.27|||Regression, Cox|||||1.27|0.30|
71753913|NCT02443688|143011309|OTHER|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.57|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.31|1.05|||Regression, Cox|||||1.05|0.31|
71753914|NCT03182374|143011315|SUPERIORITY||||||<|0.0001||||||ITT Population|t-test, 2 sided|||||||<0.0001
71753915|NCT03182374|143011316|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
71753916|NCT03182374|143011317|SUPERIORITY|||||||0.6655||||||PP Population|t-test, 2 sided|||||||0.6655
71753917|NCT03182374|143011318|SUPERIORITY||||||<|0.0001||||||PP Population|t-test, 2 sided|||||||<0.0001
71753918|NCT03182374|143011319|SUPERIORITY||||||<|0.05||||||PP population|t-test, 2 sided|||||||<0.05
71669878|NCT02892331|142857153|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change in complex IV (CON vs. MOD-INT)||||0.097
71669879|NCT02892331|142857153|SUPERIORITY|||||||0.468|||||||ANCOVA|||Change in complex IV||||0.468
71669880|NCT02892331|142857153|SUPERIORITY|||||||0.589|||||||ANCOVA|||Change in complex V||||0.589
71669881|NCT02892331|142857153|SUPERIORITY|||||||0.196|||||||ANCOVA|||Change in complex V (CON vs. MOD-INT)||||0.196
71669882|NCT02892331|142857153|SUPERIORITY|||||||0.436|||||||ANCOVA|||Change in Complex V (MOD-INT vs. HIGH-INT)||||0.436
71669883|NCT02892331|142857154|SUPERIORITY|||||||0.756|||||||ANCOVA|||Comparison of general health subscale (CON vs. HIGH INT)||||0.756
71669884|NCT02892331|142857154|SUPERIORITY|||||||0.115|||||||ANCOVA|||General Health Subscale (CON vs. MOD-INT)||||0.115
71669885|NCT02892331|142857154|SUPERIORITY|||||||0.225|||||||ANCOVA|||General Health Subscale (MOD-INT vs. HIGH-INT)||||0.225
71753919|NCT03182374|143011320|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71753920|NCT01231984|143011344|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 8mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units.|Effect of 4mm versus 8mm PN on HbA1c|-0.076|||||TWO_SIDED|95.0|-0.209|0.058|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.058|-0.209|
71753921|NCT01231984|143011345|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4 mm PN and the longer PNs (pooled) was calculated. Equivalence limits for HbA1c were defined a-priori as +/- 0.4% units.|Effect of 4mm PN vs. longer PN on HbA1c|-0.09|||||TWO_SIDED|95.0|-0.23|0.051|||Two one-sided 95% confidence limits|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||0.051|-0.23|
71753922|NCT01231984|143011346|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.36|||<|0.05|ONE_SIDED|95.0|0.37|||p\< 0.05 was considered statistically significant in this study|t-test, 1 sided|||"Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period."|||0.37|<0.05
71786417|NCT03765918|143071411|OTHER|Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen \& Nurminen method stratified by primary tumor site and tumor stage.|Difference in Percentage|3.1||||0.0006|TWO_SIDED|95.0|1.6|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen|||||5.6|1.6|0.0006
71786418|NCT03765918|143071418|OTHER|Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.29||||0.4671|TWO_SIDED|95.0|-4.78|2.2||Two-sided p-value based on cLDA model.|cLDA model|||||2.20|-4.78|0.4671
71786419|NCT03765918|143071419|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1606|TWO_SIDED|95.0|-7.27|1.21||Two-sided p-value based on cLDA model.|cLDA model|||||1.21|-7.27|0.1606
71786420|NCT03765918|143071420|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.41||||0.4374|TWO_SIDED|95.0|-4.96|2.15||Two-sided p-value based on cLDA model.|cLDA model|||||2.15|-4.96|0.4374
71786421|NCT03765918|143071421|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.39||||0.8379|TWO_SIDED|95.0|-3.35|4.13||Two-sided p-value based on cLDA model.|cLDA model|||||4.13|-3.35|0.8379
71786422|NCT03765918|143071422|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.39||||0.8643|TWO_SIDED|95.0|-4.84|4.07||Two-sided p-value based on cLDA model.|cLDA model|||||4.07|-4.84|0.8643
71786423|NCT03765918|143071423|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.29||||0.8813|TWO_SIDED|95.0|-4.12|3.54||Two-sided p-value based on cLDA model.|cLDA model|||||3.54|-4.12|0.8813
71786424|NCT03765918|143071430|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.34||||0.8287|TWO_SIDED|95.0|-2.76|3.45||Two-sided p-value based on cLDA model.|cLDA model|||||3.45|-2.76|0.8287
71786425|NCT03765918|143071431|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.53||||0.7761|TWO_SIDED|95.0|-3.12|4.18||Two-sided p-value based on cLDA model.|cLDA model|||||4.18|-3.12|0.7761
71786426|NCT03765918|143071432|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.65||||0.688|TWO_SIDED|95.0|-2.54|3.84||Two-sided p-value based on cLDA model.|cLDA model|||||3.84|-2.54|0.6880
71786427|NCT03765918|143071433|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.45||||0.3858|TWO_SIDED|95.0|-4.73|1.83||Two-sided p-value based on cLDA model.|cLDA model|||||1.83|-4.73|0.3858
71786428|NCT03765918|143071434|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.45||||0.237|TWO_SIDED|95.0|-6.53|1.62||Two-sided p-value based on cLDA model.|cLDA model|||||1.62|-6.53|0.2370
71786429|NCT03765918|143071435|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.76||||0.3138|TWO_SIDED|95.0|-5.2|1.67||Two-sided p-value based on cLDA model.|cLDA model|||||1.67|-5.20|0.3138
71786430|NCT03765918|143071442|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.28||||0.1763|TWO_SIDED|95.0|-8.05|1.48||Two-sided p-value based on cLDA model.|cLDA model|||||1.48|-8.05|0.1763
71786431|NCT03765918|143071443|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-1.18||||0.6882|TWO_SIDED|95.0|-6.95|4.59||Two-sided p-value based on cLDA model.|cLDA model|||||4.59|-6.95|0.6882
71786432|NCT03765918|143071444|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.52||||0.3103|TWO_SIDED|95.0|-7.39|2.35||Two-sided p-value based on cLDA model.|cLDA model|||||2.35|-7.39|0.3103
71669886|NCT02892331|142857154|SUPERIORITY|||||||0.758|||||||ANCOVA|||Physical health Sub-scale (CON vs. HIGH-INT)||||0.758
71669887|NCT02892331|142857154|SUPERIORITY|||||||0.759|||||||ANCOVA|||Physical health subscale (CON vs. MOD-INT)||||0.759
71669888|NCT02892331|142857154|SUPERIORITY|||||||0.465|||||||ANCOVA|||Physical Health subscale (MOD-INT vs. HIGH-INT)||||0.465
71669889|NCT02892331|142857154|SUPERIORITY|||||||0.549|||||||ANCOVA|||Role Physical subscale (CON vs. HIGH-INT)||||0.549
71669890|NCT02892331|142857154|SUPERIORITY|||||||0.679|||||||ANCOVA|||Role Physical Subscale (CON vs. MOD-INT)||||0.679
71669891|NCT02892331|142857154|SUPERIORITY|||||||0.334|||||||ANCOVA|||Role Physical Subscale (MOD-INT vs. HIGH-INT)||||0.334
71669892|NCT02892331|142857154|SUPERIORITY|||||||0.273|||||||ANCOVA|||Bodily pain subscale (CON vs. HIGH-INT)||||0.273
71669893|NCT02892331|142857154|SUPERIORITY|||||||0.642|||||||ANCOVA|||Bodily pain subscale (CON vs. MOD-INT)||||0.642
71753923|NCT01231984|143011347|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.83|||<|0.05|ONE_SIDED|95.0|18.54|||p\< 0.05 was considered statistically significant in this study.|t-test, 1 sided||||||18.54|<0.05
71836583|NCT03281291|143179162|OTHER||Vaccine Efficacy|29.7|||||TWO_SIDED|95.0|14.7|42.1|||Regression, Cox||VE = 1 minus the Hazard Ratio (HR). HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy (VE) in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||42.1|14.7|
71836584|NCT03281291|143179162|OTHER||Vaccine Efficacy|31.2|||||TWO_SIDED|95.0|16.4|43.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||43.3|16.4|
71891902|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-30.6|||||TWO_SIDED|95.0|-41.4|-19.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.8|-41.4|
71891903|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-20.8|||||TWO_SIDED|95.0|-27.0|-14.7||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-14.7|-27.0|
71891904|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-7.0|||||TWO_SIDED|95.0|-13.6|-0.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.3|-13.6|
71669894|NCT02892331|142857154|SUPERIORITY|||||||0.52|||||||ANCOVA|||Bodily Pain Subscale (MOD-INT vs. HIGH-INT)||||0.520
71669895|NCT02892331|142857154|SUPERIORITY|||||||0.46|||||||ANCOVA|||Vitality subscale (CON vs. HIGH-INT)||||0.460
71753924|NCT01231984|143011349|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 12.7mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units|Effect of 4 mm vs.12.7mm PN on HbA1c|-0.095|||||TWO_SIDED|95.0|-0.19|0.0|||Two one-sided 95% confidence limit|For equivalence testing, a 95% test is the same as two one-sided 95% confidence limits.||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.||-0.000|-0.190|
71753925|NCT02923726|143011351|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.9|0.57|0.92|||Log Rank||Shock only was the reference group. Confidence interval adjusted for interim analyses.|||0.92|0.57|0.005
71753926|NCT02923726|143011352|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.284|TWO_SIDED|95.0|0.78|1.07|||Log Rank||Shock Only was the reference group.|||1.07|0.78|0.284
71753927|NCT02923726|143011353|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.56|0.95|||Log Rank||Shock Only arm is reference group.|||0.95|0.56|0.020
71753928|NCT02923726|143011354|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.033|TWO_SIDED|95.0|0.44|0.97|||Log Rank||Shock Only is the reference group.|||0.97|0.44|0.033
71753929|NCT02923726|143011355|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.184|TWO_SIDED|95.0|0.94|1.41|||Log Rank||Shock Only is the reference group.|||1.41|0.94|0.184
71669896|NCT02892331|142857154|SUPERIORITY|||||||0.203|||||||ANCOVA|||Vitality sub-scale (CON vs. MOD-INT group)||||0.203
71753930|NCT03402217|143011360|SUPERIORITY|||||||0.383|||||||Wilcoxon (Mann-Whitney)|||Pre and post-score paired comparison.||||.383
71753931|NCT03402217|143011361|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Information pre-post paired comparison||||.001
71753932|NCT03402217|143011361|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Motivation pre- and post-paired comparison.||||.07
71753933|NCT03402217|143011361|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Behavior pre and post paired comparison||||.230
71753934|NCT02992288|143011391|SUPERIORITY|||||||0.2297||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2297
71753935|NCT02992288|143011391|SUPERIORITY|||||||0.4409||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4409
71836585|NCT03281291|143179162|OTHER||Vaccine Efficacy|24.6|||||TWO_SIDED|95.0|9.0|37.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||37.6|9.0|
71669897|NCT02892331|142857154|SUPERIORITY|||||||0.058|||||||ANCOVA|||Vitality subscale (MOD-INT vs. HIGH-INT)||||0.058
71669898|NCT02892331|142857154|SUPERIORITY|||||||0.739|||||||ANCOVA|||Social Function subscale (CON vs. HIGH-INT)||||0.739
71669899|NCT02892331|142857154|SUPERIORITY|||||||0.059|||||||ANCOVA|||Social Function subscale (CON vs. MOD-INT)||||0.059
71669900|NCT02892331|142857154|SUPERIORITY|||||||0.038|||||||ANCOVA|||Social Function sub-scale (HIGH-INT vs. MOD-INT)||||0.0380
71836586|NCT03281291|143179162|OTHER||Vaccine Efficacy|28.8|||||TWO_SIDED|95.0|13.9|41.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||41.1|13.9|
71753936|NCT02992288|143011391|SUPERIORITY|||||||0.2842||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2842
71836587|NCT03281291|143179163|OTHER||Vaccine Efficacy|42.8|||||TWO_SIDED|95.0|30.7|52.8|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||52.8|30.7|
71836588|NCT03281291|143179163|OTHER||Vaccine Efficacy|36.7|||||TWO_SIDED|95.0|21.2|49.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 14, for Fx012-14-mFxD Group vs Control Group.||49.2|21.2|
71836589|NCT03281291|143179163|OTHER||Vaccine Efficacy|41.4|||||TWO_SIDED|95.0|26.7|53.1|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 19, for Fx017-mFxD Group vs Control Group.||53.1|26.7|
71836590|NCT03281291|143179164|OTHER||Vaccine Efficacy|29.6|||||TWO_SIDED|95.0|15.4|41.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||41.5|15.4|
71836591|NCT03281291|143179164|OTHER||Vaccine Efficacy|30.6|||||TWO_SIDED|95.0|16.6|42.2|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||42.2|16.6|
71836592|NCT03281291|143179164|OTHER||Vaccine Efficacy|27.4|||||TWO_SIDED|95.0|13.1|39.4|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||39.4|13.1|
71836593|NCT03281291|143179164|OTHER||Vaccine Efficacy|26.3|||||TWO_SIDED|95.0|11.9|38.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the TVC against the first new genotypic infection, between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||38.3|11.9|
71836594|NCT03281291|143179165|OTHER||Vaccine Efficacy|41.8|||||TWO_SIDED|95.0|28.6|52.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-20 Group vs Control Group.||52.5|28.6|
71836595|NCT03281291|143179165|OTHER||Vaccine Efficacy|39.9|||||TWO_SIDED|95.0|26.8|50.6|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for R012-14-mD Group vs Control Group.||50.6|26.8|
71753937|NCT02992288|143011391|SUPERIORITY|||||||0.2534||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.2534
71836596|NCT03281291|143179165|OTHER||Vaccine Efficacy|33.6|||||TWO_SIDED|95.0|19.3|45.3|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 2.5 and 26, for Fx012-14-mFxD Group vs Control Group.||45.3|19.3|
71753938|NCT02992288|143011391|SUPERIORITY|||||||0.3842||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.3842
71836597|NCT03281291|143179165|OTHER||Vaccine Efficacy|40.6|||||TWO_SIDED|95.0|27.2|51.5|||Regression, Cox||VE = 1 minus HR. HR was defined as the ratio of relative risk of infection in the vaccinated group compared to the control group.|Comparison of vaccine efficacy in the ATP cohort against the first new genotypic infection, between months 7.5 and 31, for Fx017-mFxD Group vs Control Group.||51.5|27.2|
71836598|NCT03281291|143179166|OTHER||Additive difference|-1.5|||||TWO_SIDED|95.0|-1.979|-1.022|||Wald Test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-20 Group vs Control Group.||-1.022|-1.979|
71836599|NCT03281291|143179166|OTHER||Additive difference|-1.544|||||TWO_SIDED|95.0|-2.027|-1.061|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for R012-14-mD Group vs Control Group.||-1.061|-2.027|
71845452|NCT00291694|143205219|SUPERIORITY_OR_OTHER|||||||0.39||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.39
71845453|NCT00291694|143205220|SUPERIORITY_OR_OTHER|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.37
71753939|NCT02992288|143011392|SUPERIORITY|||||||0.8966||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8966
71753940|NCT02992288|143011392|SUPERIORITY|||||||0.9233||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9233
71753941|NCT02992288|143011392|SUPERIORITY|||||||0.9296||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9296
71753942|NCT02992288|143011392|SUPERIORITY|||||||0.7357||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7357
71753943|NCT02992288|143011392|SUPERIORITY|||||||0.9083||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9083
71753944|NCT02992288|143011393|SUPERIORITY|||||||0.4596||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.4596
71753945|NCT02992288|143011393|SUPERIORITY|||||||0.7859||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7859
71753946|NCT02992288|143011393|SUPERIORITY|||||||0.5562||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5562
71753947|NCT02992288|143011393|SUPERIORITY|||||||0.5338||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5338
71753948|NCT02992288|143011393|SUPERIORITY|||||||0.7303||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.7303
71753949|NCT02992288|143011394|SUPERIORITY|||||||0.5703||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.5703
71753950|NCT02992288|143011394|SUPERIORITY|||||||0.8253||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8253
71845454|NCT01367236|143205248|SUPERIORITY|||||||0.68|||||||Regression, Linear|||24 weeks||||0.68
71669901|NCT02892331|142857154|SUPERIORITY|||||||0.95|||||||ANCOVA|||Comparison of mental health subscale (CON vs. HIGH-INT)||||0.950
71669902|NCT02892331|142857154|SUPERIORITY|||||||0.096|||||||ANCOVA|||Change in mental health subscale (CON Vs. MOD INT)||||0.096
71669903|NCT02892331|142857154|SUPERIORITY|||||||0.127|||||||ANCOVA|||Change in mental health subscale (MOD-INT vs. HIGH-INT)||||0.127
71845455|NCT01367236|143205248|SUPERIORITY|||||||0.43|||||||Regression, Linear|||48 weeks||||0.43
71845456|NCT01367236|143205249|SUPERIORITY|||||||0.0009|||||||Regression, Linear|||||||0.0009
71669904|NCT02892331|142857154|SUPERIORITY|||||||0.373|||||||ANCOVA|||Change in role emotional subscale (CON vs HIGH-INT)||||0.373
71669905|NCT02892331|142857154|SUPERIORITY|||||||0.63|||||||ANCOVA|||Change in role emotional sub-scale||||0.630
71669906|NCT02892331|142857154|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in role emotional subscale (MOD vs. HIGH-INT)||||0.034
71669907|NCT02892331|142857154|SUPERIORITY|||||||0.07|||||||ANCOVA|||Change in role emotional subscale (CON vs. MOD-INT)||||0.070
71786433|NCT03765918|143071445|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.48||||0.8475|TWO_SIDED|95.0|-5.41|4.45||Two-sided p-value based on cLDA model.|cLDA model|||||4.45|-5.41|0.8475
71786434|NCT03765918|143071446|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.42||||0.8881|TWO_SIDED|95.0|-6.36|5.51||Two-sided p-value based on cLDA model.|cLDA model|||||5.51|-6.36|0.8881
71786435|NCT03765918|143071447|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.22||||0.9307|TWO_SIDED|95.0|-5.22|4.78||Two-sided p-value based on cLDA model.|cLDA model|||||4.78|-5.22|0.9307
71786436|NCT03765918|143071454|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|1.3||||0.5752|TWO_SIDED|95.0|-3.25|5.85||Two-sided p-value based on cLDA model.|cLDA model|||||5.85|-3.25|0.5752
71786437|NCT03765918|143071455|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.98||||0.7196|TWO_SIDED|95.0|-4.38|6.34||Two-sided p-value based on cLDA model.|cLDA model|||||6.34|-4.38|0.7196
71786438|NCT03765918|143071456|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.74||||0.7522|TWO_SIDED|95.0|-3.88|5.37||Two-sided p-value based on cLDA model.|cLDA model|||||5.37|-3.88|0.7522
71786439|NCT03765918|143071457|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-0.24||||0.9255|TWO_SIDED|95.0|-5.3|4.82||Two-sided p-value based on cLDA model.|cLDA model|||||4.82|-5.30|0.9255
71786440|NCT03765918|143071458|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|2.22||||0.4926|TWO_SIDED|95.0|-4.15|8.6||Two-sided p-value based on cLDA model.|cLDA model|||||8.60|-4.15|0.4926
71786441|NCT03765918|143071459|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.99||||0.7087|TWO_SIDED|95.0|-4.23|6.21||Two-sided p-value based on cLDA model.|cLDA model|||||6.21|-4.23|0.7087
71836600|NCT03281291|143179166|OTHER||Additive difference|-1.575|||||TWO_SIDED|95.0|-2.065|-1.085|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx012-14-mFxD Group vs Control Group.||-1.085|-2.065|
71891905|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-23.7|||||TWO_SIDED|95.0|-29.2|-18.3||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-18.3|-29.2|
71669908|NCT02892331|142857154|SUPERIORITY|||||||0.945|||||||ANCOVA|||Change in physical health sub-scale (MOD-INT vs. HIGH-INT)||||0.945
71786442|NCT03765918|143071466|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.75||||0.1654|TWO_SIDED|95.0|-6.65|1.14||Two-sided p-value based on cLDA model.|cLDA model|||||1.14|-6.65|0.1654
71786443|NCT03765918|143071467|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|0.26||||0.9117|TWO_SIDED|95.0|-4.29|4.8||Two-sided p-value based on cLDA model.|cLDA model|||||4.80|-4.29|0.9117
71786444|NCT03765918|143071468|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.22||||0.2808|TWO_SIDED|95.0|-6.25|1.82||Two-sided p-value based on cLDA model.|cLDA model|||||1.82|-6.25|0.2808
71836601|NCT03281291|143179166|OTHER||Additive difference|-1.11|||||TWO_SIDED|95.0|-1.635|-0.586|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 20 visit, for Fx017-mFxD Group vs Control Group.||-0.586|-1.635|
71669909|NCT02892331|142857155|SUPERIORITY|||||||0.65|||||||ANCOVA|||Change in the mental health sum scale (CON vs. HIGH-INT)||||0.650
71669910|NCT02892331|142857155|SUPERIORITY|||||||0.034|||||||ANCOVA|||Change in mental health (sum) subscale (MOD-INT vs. HIGH-INT)||||0.034
71669911|NCT02892331|142857155|SUPERIORITY|||||||0.33|||||||ANCOVA|||Change in physical health (sum)||||0.330
71669912|NCT02892331|142857155|SUPERIORITY|||||||0.297|||||||ANCOVA|||Change in physical health (sum) subscale||||0.297
71669913|NCT02892331|142857156|SUPERIORITY|||||||0.109|||||||ANCOVA|||Change in steps (CON vs. HIGH-INT)||||0.109
71669914|NCT02892331|142857156|SUPERIORITY|||||||0.099|||||||ANCOVA|||Change in steps (CON vs. MOD-INT)||||0.099
71669915|NCT02892331|142857156|SUPERIORITY|||||||0.947|||||||ANCOVA|||Change in steps (MOD-INT vs. HIGH-INT)||||0.947
71669916|NCT00610428|142857159|SUPERIORITY|||||||0.084||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||Survival time is defined as time to the first successful headache relief.||||0.0840
71669917|NCT00610428|142857159|SUPERIORITY|Survival time is defined as time to the first successful headache relief.||||||0.0383||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||||||0.0383
71669918|NCT02490631|142857181|SUPERIORITY|||||||0.456|||||||Chi-squared|||||||0.456
71669919|NCT02490631|142857182|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||.019
71669920|NCT05120193|142857196|NON_INFERIORITY|The primary safety analysis is performed at a one-sided Type I error rate of α = 0.05. The Farrington-Manning method is used to calculate the upper 95% confidence bound for the difference (QI - QC) between the rate of the primary safety endpoint in the investigational arm (QI) and the rate of the primary safety endpoint in the control arm (QC). If the upper confidence bound is less than 0.08, the study is considered to have demonstrated safety of the investigational device.|Risk Difference (RD)|0.005|||<|0.0001|TWO_SIDED|90.0|-0.028|0.037|||Farrington-Manning|||"The null hypothesis (H0) for the primary safety analysis is that the true rate of primary safety events for the investigational device (QI) is equal to or greater than the true rate for the control device (QC) plus a non-inferiority margin (NIM) of 0.08. The alternative hypothesis (HA) is that the rate of primary safety events for the investigational arm (QI) is less than the rate of primary safety events for the control arm (QC) plus the NIM of 0.08.~H0: QI ≥ QC + 0.08 HA: QI \< QC + 0.08"||0.037|-0.028|<0.0001
71753951|NCT02992288|143011394|SUPERIORITY|||||||0.6506||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6506
71669921|NCT05120193|142857197|NON_INFERIORITY|The primary effectiveness analysis (PSE) is performed at a one-sided Type I error rate of α = 0.025. The Farrington-Manning method is used to calculate the lower 97.5% confidence bound for the difference (PI - PC) between the rate of the PSE in the investigational arm (PI) and the rate of the PSE in the control arm (PC). If the lower confidence bound is greater than -0.15, the study is considered to have demonstrated effectiveness of the investigational device.|Risk Difference (RD)|0.08||||0.025|TWO_SIDED|95.0|-0.009|0.168|||Farrington-Manning|||"The null hypothesis (H0) is that the true rate of primary effectiveness endpoint success (no failures through Day 360) for the investigational device (PI) is less than or equal to the true rate for the control device (PC) minus the NIM of 0.15. The alternative hypothesis (HA) is that the success rate for the investigational arm (PI) is greater than the success rate for the control device (PC) minus the NIM of 0.15.~H0: PI ≤ PC - 0.15 HA: PI \> PC - 0.15"||0.168|-0.009|0.025
71753952|NCT02992288|143011394|SUPERIORITY|||||||0.6923||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.6923
71753953|NCT02992288|143011394|SUPERIORITY|||||||0.8036||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.8036
71669922|NCT05120193|142857198|SUPERIORITY||Mean Difference (Final Values)|-29.2|||<|0.0001|TWO_SIDED|95.0|-31.7|-26.8|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean total energy application time during the ablation procedure for the investigational device (ETI) is greater than or equal to the mean time for the control device (ETC). The alternative hypothesis (HA) is that the mean total energy application time for the investigational device is less.~H0: ETI ≥ ETC versus HA: ETI \< ETC"||-26.8|-31.7|<0.0001
71669923|NCT05120193|142857199|SUPERIORITY||Mean Difference (Final Values)|-26.8|||<|0.0001|TWO_SIDED|95.0|-32.2|-21.4|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean treatment time for the investigational device (TTI) is greater than or equal to the mean treatment time for the control device (TTC). The alternative hypothesis (HA) is that the mean treatment time for the investigational device is less.~H0: TTI ≥ TTC versus HA: TTI \< TTC"||-21.4|-32.2|<0.0001
71753954|NCT02992288|143011395|SUPERIORITY|||||||0.9955||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9955
71753955|NCT02992288|143011395|SUPERIORITY|||||||0.9946||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9946
71669924|NCT05120193|142857200|SUPERIORITY||Mean Difference (Final Values)|-25.1||||0.025|TWO_SIDED|95.0|-33.0|-17.3|||t-test, 1 sided|||"The null hypothesis (H0) is that the mean procedure time for the investigational device (PTI) is greater than or equal to the mean procedure time for the control device (PTC). The alternative hypothesis (HA) is that the mean procedure time for the investigational device is less.~H0: PTI ≥ PTC versus HA: PTI \< PTC"||-17.3|-33.0|0.025
71669925|NCT02546986|142857257|SUPERIORITY||Hazard Ratio (HR)|1.374||||0.1789|TWO_SIDED|90.0|0.926|2.038|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.038|0.926|0.1789
71669926|NCT02546986|142857258|SUPERIORITY||Disease Control Rate Difference|-13.3||||0.1572|TWO_SIDED|90.0|-29.0|3.5|||Cochran-Mantel-Haenszel|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma||||3.5|-29.0|0.1572
71836602|NCT03281291|143179167|OTHER||Additive difference|-0.769|||||TWO_SIDED|95.0|-1.068|-0.469|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for R012-20 + R012-14-mD Pooled Group vs Control Group.||-0.469|-1.068|
71836603|NCT03281291|143179167|OTHER||Additive difference|-0.786|||||TWO_SIDED|95.0|-1.133|-0.439|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 14, for Fx012-14-mFxD groups vs Control Group.||-0.439|-1.133|
71836604|NCT03281291|143179167|OTHER||Additive difference|-1.275|||||TWO_SIDED|95.0|-1.592|-0.959|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 19, for Fx017-mFxD groups vs Control Group.||-0.959|-1.592|
71836605|NCT03281291|143179168|OTHER||Additive difference|-2.686|||||TWO_SIDED|95.0|-3.448|-1.924|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-20 Group vs Control Group.||-1.924|-3.448|
71836606|NCT03281291|143179168|OTHER||Additive difference|-2.452|||||TWO_SIDED|95.0|-3.217|-1.686|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for R012-14-mD Group vs Control Group.||-1.686|-3.217|
71836607|NCT03281291|143179168|OTHER||Additive difference|-2.585|||||TWO_SIDED|95.0|-3.345|-1.824|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx012-14-mFxD Group vs Control Group.||-1.824|-3.345|
71836608|NCT03281291|143179168|OTHER||Additive difference|-1.897|||||TWO_SIDED|95.0|-2.726|-1.067|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the TVC between enrollment and Month 32 visit, for Fx017-mFxD Group vs Control Group.||-1.067|-2.726|
71836609|NCT03281291|143179169|OTHER||Additive difference|-1.633|||||TWO_SIDED|95.0|-2.252|-1.015|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-20 group vs Control Group.||-1.015|-2.252|
71836610|NCT03281291|143179169|OTHER||Additive difference|-1.997|||||TWO_SIDED|95.0|-2.601|-1.393|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for R012-14 group vs Control Group.||-1.393|-2.601|
71753956|NCT02992288|143011395|SUPERIORITY|||||||0.9913||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9913
71836611|NCT03281291|143179169|OTHER||Additive difference|-1.776|||||TWO_SIDED|95.0|-2.399|-1.153|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 2.5 to 26, for Fx012-14-mFxD group vs Control Group.||-1.153|-2.399|
71836612|NCT03281291|143179169|OTHER||Additive difference|-1.843|||||TWO_SIDED|95.0|-2.527|-1.158|||Wald test|Wald tests were used to test for additive differences in VE differing from zero and to obtain a 95% confidence interval.|Additive difference was defined as the difference in the mean number of new molecularly confirmed malaria infections between each vaccine arm and the control arm.|To detect a significant difference in the mean number of new molecularly confirmed malaria infections in the ATP cohort between months 7.5 to 31, for Fx017-mFxD group vs Control Group.||-1.158|-2.527|
71836613|NCT04382898|143179188|SUPERIORITY|||||||0.1041|||||||Fisher Exact|||||||0.1041
71753957|NCT02992288|143011395|SUPERIORITY|||||||0.9982||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9982
71669927|NCT02546986|142857259|SUPERIORITY||Hazard Ratio (HR)|1.375||||0.2968|TWO_SIDED|90.0|0.83|2.276|||Stratified Log Rank|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).|Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.|||2.276|0.830|0.2968
71753958|NCT02992288|143011395|SUPERIORITY|||||||0.9959||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.||||||0.9959
71753959|NCT03416985|143011399|OTHER|||||||0.1561||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to plaque level after 30 days||||0.1561
71753960|NCT03416985|143011400|OTHER|||||||0.2161||||||p \< 0.05 considered significant|ANOVA|||Compare groups with respect to Gingival scores at 30 days||||0.2161
71753961|NCT02006472|143011401|SUPERIORITY||LSM difference|1.42||||0.3202|TWO_SIDED|95.0|-1.39|4.23|||Mixed Models Analysis|||||4.23|-1.39|0.3202
71753962|NCT02006472|143011401|SUPERIORITY||LSM difference|1.7||||0.2266|TWO_SIDED|95.0|-1.06|4.46|||Mixed Models Analysis|||||4.46|-1.06|0.2266
71753963|NCT02006472|143011401|SUPERIORITY||LSM difference|0.66||||0.6348|TWO_SIDED|95.0|-2.07|3.39|||Mixed Models Analysis|||||3.39|-2.07|0.6348
71753964|NCT02006472|143011401|SUPERIORITY||LSM difference|2.04||||0.1447|TWO_SIDED|95.0|-0.71|4.8|||Mixed Models Analysis|||||4.8|-0.71|0.1447
71753965|NCT02006472|143011403|SUPERIORITY||LSM difference|0.87||||0.0032|TWO_SIDED|95.0|0.29|1.45|||Mixed Models Analysis|||||1.45|0.29|0.0032
71753966|NCT02006472|143011403|SUPERIORITY||LSM difference|0.11||||0.7042|TWO_SIDED|95.0|-0.46|0.68|||Mixed Models Analysis|||||0.68|-0.46|0.7042
71753967|NCT02006472|143011403|SUPERIORITY||LSM difference|0.19||||0.5099|TWO_SIDED|95.0|-0.37|0.75|||Mixed Models Analysis|||||0.75|-0.37|0.5099
71753968|NCT02006472|143011403|SUPERIORITY||LSM difference|0.24||||0.4061|TWO_SIDED|95.0|-0.33|0.82|||Mixed Models Analysis|||||0.82|-0.33|0.4061
71753969|NCT02006472|143011404|SUPERIORITY||LSM difference|1.16||||0.0003|TWO_SIDED|95.0|0.54|1.78|||Mixed Models Analysis|||||1.78|0.54|0.0003
71753970|NCT02006472|143011405|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71753971|NCT02006472|143011406|SUPERIORITY||LSM difference|-0.0341||||0.0346|TWO_SIDED|95.0|-0.0658|-0.0026|||Mixed Models Analysis|||At Week 26||-0.0026|-0.0658|0.0346
71753972|NCT02006472|143011406|SUPERIORITY||LSM difference|-0.0444||||0.0305|TWO_SIDED|95.0|-0.0847|-0.0042|||Mixed Models Analysis|||At Week 52||-0.0042|-0.0847|0.0305
71753973|NCT00656513|143011408|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%||||0.45
71753974|NCT00656513|143011410|SUPERIORITY|||||||0.11||||||Two-sided test of values at 4 months.|Wilcoxon (Mann-Whitney)|||||||0.11
71753975|NCT00656513|143011410|SUPERIORITY|||||||0.31||||||Two-sided test of values at 6 months.|Wilcoxon (Mann-Whitney)|||||||0.31
71753976|NCT00656513|143011410|SUPERIORITY|||||||0.21||||||Two-sided test of values at 15 months.|Wilcoxon (Mann-Whitney)|||||||0.21
71753977|NCT00656513|143011411|SUPERIORITY|||||||0.35||||||4-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.35
71753978|NCT00656513|143011411|SUPERIORITY|||||||0.78||||||4 months Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
71753979|NCT00656513|143011411|SUPERIORITY|||||||0.12||||||4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.12
71753980|NCT00656513|143011411|SUPERIORITY|||||||0.28||||||4-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
71753981|NCT00656513|143011411|SUPERIORITY|||||||0.98||||||6-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.98
71753982|NCT00656513|143011411|SUPERIORITY|||||||0.28||||||6-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
71753983|NCT00656513|143011411|SUPERIORITY|||||||0.13||||||6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.13
71753984|NCT00656513|143011411|SUPERIORITY|||||||0.58||||||6-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
71753985|NCT00656513|143011411|SUPERIORITY|||||||0.88||||||9-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.88
71753986|NCT00656513|143011411|SUPERIORITY|||||||0.09||||||9-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.09
71753987|NCT00656513|143011411|SUPERIORITY|||||||0.49||||||9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.49
71753988|NCT00656513|143011411|SUPERIORITY|||||||0.45||||||9-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
71753989|NCT00656513|143011411|SUPERIORITY|||||||0.45||||||15-month Physical Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.45
71753990|NCT00656513|143011411|SUPERIORITY|||||||0.3||||||15-month Pain/Discomfort; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
71753991|NCT00656513|143011411|SUPERIORITY|||||||0.48||||||15-month Personal/Psychological Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.48
71753992|NCT00656513|143011411|SUPERIORITY|||||||0.68||||||15-month Social Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.68
71753993|NCT00656513|143011412|SUPERIORITY|||||||0.97||||||4-month score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.97
71753994|NCT00656513|143011412|SUPERIORITY|||||||0.83||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.83
71753995|NCT00656513|143011412|SUPERIORITY|||||||0.28||||||9-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.28
71836614|NCT04382898|143179194|SUPERIORITY|||||||0.0541|||||||Binomial test|||||||0.0541
71836615|NCT05229120|143179195|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.124|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||A single-sided paired-samples t-test comparing k-values at baseline to k-values at follow-up (approximately 4 weeks after baseline assessment) was examined. Given that k-values are typically skewed (and to be consistent with the existing literature) we used a log-k as our outcome variable.||||.124
71836616|NCT05229120|143179196|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.219|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 14.||Changes in consideration of future consequences (parenting) was evaluated using one-sided paired samples t-tests.||||.219
71836617|NCT05229120|143179197|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5|TWO_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 5||Performed a one-sided paired samples t-test examining changes in both positive parenting.||||.50
71836618|NCT05229120|143179197|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.187|TWO_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in negative parenting.||||.187
71836619|NCT05229120|143179198|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.498|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental involvement using a paired-samples t-test.||||.498
71836620|NCT05229120|143179198|SUPERIORITY||Mean Difference (Final Values)|1.301||||0.108|TWO_SIDED||||||t-test, 1 sided|||Examined changes in positive parenting using paired samples t-tests||||.108
71669928|NCT02546986|142857260|SUPERIORITY||Overall Response Rate (ORR) Difference|5.3|||||TWO_SIDED|90.0|-11.5|21.3|||||The 90% exact unconditional confidence interval was used for ORR difference.|||21.3|-11.5|
71753996|NCT00656513|143011412|SUPERIORITY|||||||0.89||||||15-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.89
71753997|NCT00656513|143011413|SUPERIORITY|||||||0.54||||||4-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.54
71836621|NCT05229120|143179198|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.145|TWO_SIDED||||||t-test, 1 sided|||Examined changes in parental monitoring using a paired samples t-test||||.145
71836622|NCT05229120|143179198|SUPERIORITY||Mean Difference (Final Values)|-0.688||||0.252|TWO_SIDED||||||t-test, 1 sided|||Examined changes in inconsistent parenting using a paired samples one-sided t-test||||.252
71836623|NCT05229120|143179198|SUPERIORITY||Mean Difference (Final Values)|0.306||||0.382|TWO_SIDED||||||t-test, 1 sided|||Examined changes in corporal punishment using a paired samples one-tailed t-test||||.382
71836624|NCT03932682|143179207|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided confidence interval (CI) for absolute vaccine efficacy (aVE) of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|41.26|||||TWO_SIDED|97.98|21.55|56.02||||||||56.02|21.55|
71836625|NCT03932682|143179208|OTHER|The primary objective would be achieved if efficacy was demonstrated for at least one of the two primary efficacy endpoints, that is, if the interim analysis-adjusted lower limit of the two-sided CI for aVE of QIVc versus the comparator vaccine was greater than 0%.|Cox Proportional Hazard|46.9|||||TWO_SIDED|97.5|19.19|65.11||||||||65.11|19.19|
71836626|NCT03932682|143179209|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|54.49|||||TWO_SIDED|95.0|22.55|73.26||||||||73.26|22.55|
71836627|NCT03932682|143179210|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|50.67|||||TWO_SIDED|95.0|32.83|63.77||||||||63.77|32.83|
71753998|NCT00656513|143011413|SUPERIORITY|||||||0.99||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
71753999|NCT00656513|143011413|SUPERIORITY|||||||0.56||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.56
71754000|NCT00656513|143011413|SUPERIORITY|||||||0.58||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)|||||||0.58
71754001|NCT00656513|143011414|SUPERIORITY|||||||0.14||||||Two-sided test, significance level 0.05|t-test, 2 sided|||||||0.14
71836628|NCT03932682|143179211|OTHER|The secondary efficacy objectives were not associated with any hypothesis testing|Cox Proportional Hazard|100.0|||||TWO_SIDED|95.0|||||||"The 2-sided 95% confidence interval was calculated with a lower limit of not estimable and an upper limit of 100."|||||
71836629|NCT01566695|143179250|SUPERIORITY||Rate Difference|18.9||||0.0005|TWO_SIDED|95.0|8.3|29.6||2 sided|Stratified Mantel-Haenszel Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||29.6|8.3|0.0005
71836630|NCT01566695|143179254|SUPERIORITY||Rate Difference|21.6|||<|0.0001|TWO_SIDED|95.0|11.9|31.3||2 sided|Stratified Mantel-Haenszel; Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 vs \>4 units of RBC per 28 days; BL platelet tfx status: dependent or ind. \&ECOG PS: 0 to 1 vs 2||||31.3|11.9|<0.0001
71836631|NCT01566695|143179255|SUPERIORITY|||||||0.4347|||||||Two-Sided Unstratified Log Rank Test|||||||0.4347
71836632|NCT01566695|143179257|SUPERIORITY|HI-E|Rate Difference|10.9||||0.1467|TWO_SIDED|95.0|-2.0|23.7|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.7|-2.0|0.1467
71669929|NCT02546986|142857262|SUPERIORITY||Hazard Ratio (HR)|1.352||||0.199|TWO_SIDED|90.0|0.914|2.0|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model|||2.000|0.914|0.1990
71669930|NCT05016960|142857274|OTHER|one group paired samples t test to compare scores at pre vs. post treatment||||||0.503|||||||t-test, 2 sided|||||||.503
71754002|NCT03486912|143011439|SUPERIORITY||Odds Ratio (OR)|0.88||||0.773|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.773
71836633|NCT01566695|143179257|SUPERIORITY|≥ 1.5 g/dL Hemoglobin Increase|Rate Diffrence|17.9||||0.0002|TWO_SIDED|95.0|8.8|26.9|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.9|8.8|0.0002
71836634|NCT01566695|143179257|SUPERIORITY|RBC Transfusion Reduction|Rate Difference|10.9||||0.1431|TWO_SIDED|95.0|-1.9|23.6|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||23.6|-1.9|0.1431
71669931|NCT05016960|142857275|NON_INFERIORITY|one group paired samples t test||||||0.23|||||||t-test, 2 sided|||||||.230
71669932|NCT05016960|142857276|OTHER|one group paired samples t test||||||0.061|||||||t-test, 2 sided|||||||.061
71754003|NCT03486912|143011439|SUPERIORITY||Odds Ratio (OR)|0.72||||0.544|TWO_SIDED|95.0|0.23|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.23|0.544
71669933|NCT05016960|142857277|OTHER|one group paired samples t test|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71669934|NCT05016960|142857278|OTHER|one group paired samples t test||||||0.01|||||||t-test, 2 sided|||||||.01
71669935|NCT05016960|142857279|OTHER|one group paired samples t test||||||0.625|||||||t-test, 2 sided|||||||.625
71669936|NCT05016960|142857280|OTHER|one group paired samples t test||||||0.134|||||||t-test, 2 sided|||||||.134
71669937|NCT05016960|142857281|OTHER|one group paired samples t test||||||0.515|||||||t-test, 2 sided|||||||.515
71669938|NCT05016960|142857282|OTHER|one group paired samples t test||||||0.41|||||||t-test, 2 sided|||||||.410
71669939|NCT05016960|142857283|OTHER|one group paired samples t test||||||0.706|||||||t-test, 2 sided|||||||.706
71669940|NCT05016960|142857284|OTHER|one group paired samples t test||||||0.062|||||||t-test, 2 sided|||||||.062
71754004|NCT03486912|143011439|SUPERIORITY||Odds Ratio (OR)|0.88||||0.811|TWO_SIDED|95.0|0.3|2.62|||Cochran-Mantel-Haenszel|||||2.62|0.30|0.811
71754005|NCT03486912|143011440|SUPERIORITY||Odds Ratio (OR)|1.12||||0.836|TWO_SIDED|95.0|0.4|3.09|||Cochran-Mantel-Haenszel|||||3.09|0.40|0.836
71754006|NCT03486912|143011440|SUPERIORITY||Odds Ratio (OR)|0.86||||0.763|TWO_SIDED|95.0|0.3|2.46|||Cochran-Mantel-Haenszel|||||2.46|0.30|0.763
71754007|NCT03486912|143011440|SUPERIORITY||Odds Ratio (OR)|0.89||||0.821|TWO_SIDED|95.0|0.32|2.51|||Cochran-Mantel-Haenszel|||||2.51|0.32|0.821
71754008|NCT03486912|143011441|SUPERIORITY||Odds Ratio (OR)|1.13||||0.837|TWO_SIDED|95.0|0.39|3.25|||Cochran-Mantel-Haenszel|||||3.25|0.39|0.837
71754009|NCT03486912|143011441|SUPERIORITY||Odds Ratio (OR)|1.53||||0.359|TWO_SIDED|95.0|0.54|4.4|||Cochran-Mantel-Haenszel|||||4.40|0.54|0.359
71754010|NCT03486912|143011441|SUPERIORITY||Odds Ratio (OR)|1.26||||0.627|TWO_SIDED|95.0|0.44|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.44|0.627
71754011|NCT03486912|143011442|SUPERIORITY||Odds Ratio (OR)|1.12||||0.864|TWO_SIDED|95.0|0.4|3.16|||Cochran-Mantel-Haenszel|||||3.16|0.40|0.864
71754012|NCT03486912|143011442|SUPERIORITY||Odds Ratio (OR)|0.85||||0.743|TWO_SIDED|95.0|0.29|2.49|||Cochran-Mantel-Haenszel|||||2.49|0.29|0.743
71754013|NCT03486912|143011442|SUPERIORITY||Odds Ratio (OR)|0.79||||0.63|TWO_SIDED|95.0|0.27|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.27|0.630
71754014|NCT03486912|143011443|SUPERIORITY||Odds Ratio (OR)|1.43||||0.477|TWO_SIDED|95.0|0.48|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.48|0.477
71754015|NCT03486912|143011443|SUPERIORITY||Odds Ratio (OR)|1.04||||0.814|TWO_SIDED|95.0|0.32|3.44|||Cochran-Mantel-Haenszel|||||3.44|0.32|0.814
71754016|NCT03486912|143011443|SUPERIORITY||Odds Ratio (OR)|0.64||||0.367|TWO_SIDED|95.0|0.21|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.21|0.367
71754017|NCT03486912|143011444|SUPERIORITY|||||||0.309|||||||Cochran-Mantel-Haenszel|||||||0.309
71754018|NCT03486912|143011444|SUPERIORITY|||||||0.146|||||||Cochran-Mantel-Haenszel|||||||0.146
71786445|NCT03765918|143071469|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.77||||0.1577|TWO_SIDED|95.0|-6.62|1.08||Two-sided p-value based on cLDA model.|cLDA model|||||1.08|-6.62|0.1577
71754019|NCT03486912|143011444|SUPERIORITY|||||||0.317|||||||Cochran-Mantel-Haenszel|||||||0.317
71754020|NCT03486912|143011445|SUPERIORITY||Odds Ratio (OR)|6.91||||0.054|TWO_SIDED|95.0|0.76|325.97|||Cochran-Mantel-Haenszel|||||325.97|0.76|0.054
71754021|NCT03486912|143011445|SUPERIORITY||Odds Ratio (OR)|12.21||||0.004|TWO_SIDED|95.0|1.5|549.08|||Cochran-Mantel-Haenszel|||||549.08|1.50|0.004
71754022|NCT03486912|143011445|SUPERIORITY||Odds Ratio (OR)|5.59||||0.087|TWO_SIDED|95.0|0.57|271.11|||Cochran-Mantel-Haenszel|||||271.11|0.57|0.087
71754023|NCT02491684|143011446|SUPERIORITY_OR_OTHER||Ratio of proportions|1.29||||0.645|TWO_SIDED|95.0|0.43|3.85|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.85|0.43|0.645
71754024|NCT02491684|143011447|SUPERIORITY_OR_OTHER||Ratio of proportions|1.97||||0.411|TWO_SIDED|95.0|0.39|9.89|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 7|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||9.89|0.39|0.411
71754025|NCT02491684|143011447|SUPERIORITY_OR_OTHER||Ratio of proportions|1.25||||0.659|TWO_SIDED|95.0|0.46|3.41|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||3.41|0.46|0.659
71754026|NCT02491684|143011448|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 14|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
71754027|NCT02491684|143011448|SUPERIORITY_OR_OTHER||Ratio of proportions|1.1||||0.944|TWO_SIDED|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.||15.79|0.08|0.944
71754028|NCT02491684|143011449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.634|TWO_SIDED|95.0|0.45|3.77|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first severe exacerbation within 30 days of treatment start.||3.77|0.45|0.634
71754029|NCT02491684|143011450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.973|TWO_SIDED|95.0|0.07|16.78|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first moderate exacerbation within 30 days of treatment start.||16.78|0.07|0.973
71669941|NCT05016960|142857285|OTHER|one group paired samples t test||||||0.39|||||||t-test, 2 sided|||||||.390
71669942|NCT05016960|142857286|OTHER|one group paired samples t test||||||0.38|||||||t-test, 2 sided|||||||.38
71754030|NCT02491684|143011452|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|0.09||||0.495|TWO_SIDED|95.0|-0.17|0.35|||ANCOVA|Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo for change from baseline in total score at Visit 4.|Analysis of change from baseline in total score at Visit 4.||0.35|-0.17|0.495
71836635|NCT01566695|143179258|SUPERIORITY||Rate Difference|17.0||||0.0007|TWO_SIDED|95.0|7.5|26.4|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus \>4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2||||26.4|7.5|0.0007
71669943|NCT05016960|142857287|OTHER|One group paired samples t test||||||0.064|||||||t-test, 2 sided|||||||.064
71669944|NCT04796961|142857288|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|0.1|0.7||||||||0.7|0.1|
71669945|NCT04796961|142857289|SUPERIORITY||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-0.1|1.1||||||smoking screening||1.1|-0.1|
71669946|NCT04796961|142857289|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.1|1.2||||||readiness to quit assessments||1.2|-0.1|
71669947|NCT04796961|142857289|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|0.8|2.0||||||smoking cessation counseling||2.0|0.8|
71754031|NCT02491684|143011452|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.715|TWO_SIDED|95.0|-0.26|0.38|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 6.||0.38|-0.26|0.715
71754032|NCT02491684|143011452|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.687|TWO_SIDED|95.0|-0.42|0.28|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 8.||0.28|-0.42|0.687
71754033|NCT02491684|143011453|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.516|TWO_SIDED|95.0|-0.23|0.45|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-14.||0.45|-0.23|0.516
71754034|NCT02491684|143011453|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.417|TWO_SIDED|95.0|-0.16|0.37|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-7.||0.37|-0.16|0.417
71754035|NCT02491684|143011453|SUPERIORITY_OR_OTHER||LS mean difference|0.01||||0.954|TWO_SIDED|95.0|-0.34|0.36|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 8-14.||0.36|-0.34|0.954
71754036|NCT02491684|143011453|SUPERIORITY_OR_OTHER||LS Mean difference|0.0||||0.985|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 15-30.||0.35|-0.35|0.985
71754037|NCT02491684|143011455|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07||||0.66|TWO_SIDED|95.0|-0.38|0.24|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 6.||0.24|-0.38|0.660
71754038|NCT02491684|143011455|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09||||0.624|TWO_SIDED|95.0|-0.48|0.29|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 8.||0.29|-0.48|0.624
71754039|NCT02491684|143011456|SUPERIORITY_OR_OTHER||LS Mean difference|0.54||||0.309|TWO_SIDED|95.0|-0.51|1.59|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||1.59|-0.51|0.309
71754040|NCT02491684|143011457|SUPERIORITY_OR_OTHER||LS Mean difference|16.98||||0.059|TWO_SIDED|95.0|-0.63|34.6|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||34.60|-0.63|0.059
71754041|NCT02491684|143011457|SUPERIORITY_OR_OTHER||LS Mean difference|19.35||||0.01|TWO_SIDED|95.0|4.66|34.05|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||34.05|4.66|0.010
71754042|NCT02491684|143011457|SUPERIORITY_OR_OTHER||LS Mean difference|14.38||||0.153|TWO_SIDED|95.0|-5.44|34.2|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||34.20|-5.44|0.153
71754043|NCT02491684|143011457|SUPERIORITY_OR_OTHER||LS Mean difference|19.26||||0.096|TWO_SIDED|95.0|-3.44|41.97|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.97|-3.44|0.096
71754044|NCT02491684|143011458|SUPERIORITY_OR_OTHER||LS Mean difference|0.07||||0.161|TWO_SIDED|95.0|-0.03|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.17|-0.03|0.161
71754045|NCT02491684|143011458|SUPERIORITY_OR_OTHER||LS Mean difference|0.08||||0.087|TWO_SIDED|95.0|-0.01|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.17|-0.01|0.087
71754046|NCT02491684|143011458|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.28|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.280
71836636|NCT01566695|143179261|OTHER||Hazard Ratio (HR)|1.08||||0.6257|TWO_SIDED|95.0|0.79|1.49|||Log Rank||||Cox proportional hazards model with stratifies factors|1.49|0.79|0.6257
71836637|NCT01566695|143179267|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.214
71836638|NCT01566695|143179268|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.446
71836639|NCT01566695|143179269|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.248
71836640|NCT01566695|143179270|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.058
71836641|NCT01566695|143179271|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.130
71836642|NCT01566695|143179272|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.123
71836643|NCT01566695|143179273|SUPERIORITY|||||||0.069|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.069
71836644|NCT01566695|143179274|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.078
71836645|NCT01566695|143179275|SUPERIORITY|||||||0.073|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.||||||0.073
71836646|NCT01566695|143179276|SUPERIORITY||Common Odds Raatio|0.77||||0.56|TWO_SIDED|95.0|0.54|1.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.30|0.54|0.560
71836647|NCT01566695|143179277|SUPERIORITY||Common Odds Raatio|0.72||||0.48|TWO_SIDED|95.0|0.29|1.78|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|1.78|0.29|0.480
71836648|NCT01566695|143179278|SUPERIORITY||Common Odds Ratio|1.67||||0.197|TWO_SIDED|95.0|0.76|3.65|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.65|0.76|0.197
71836649|NCT01566695|143179279|SUPERIORITY||Common Odds Ratio|2.14||||0.121|TWO_SIDED|95.0|0.82|5.57|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|5.57|0.82|0.121
71836650|NCT01566695|143179280|SUPERIORITY||Common Odds Ratio|2.0||||0.075|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.30|0.93|0.075
71836651|NCT01566695|143179281|SUPERIORITY||Common Odds Ratio|1.58||||0.222|TWO_SIDED|95.0|0.76|3.29|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.29|0.76|0.222
71836652|NCT01566695|143179282|SUPERIORITY||Common Odds Ratio|1.65||||0.249|TWO_SIDED|95.0|0.71|3.83|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|3.83|0.71|0.249
71836653|NCT01566695|143179283|SUPERIORITY||Common Odds Ratio|2.03||||0.082|TWO_SIDED|95.0|0.92|4.48|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.48|0.92|0.082
71836654|NCT01566695|143179284|SUPERIORITY||Common Odds Ratio|1.86||||0.153|TWO_SIDED|95.0|0.79|4.34|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.|4.34|0.79|0.153
71836655|NCT01566695|143179285|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71836656|NCT01566695|143179286|SUPERIORITY|||||||0.046|||||||Fisher Exact|||||||0.046
71669948|NCT04796961|142857289|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.7||||||smoking cessation pharmacotherapy||1.7|-0.5|
71669949|NCT02218463|142857313|SUPERIORITY|||||||0.206|||||||Fisher Exact|||Assessment of complete resolution between the 2 study arms.||||0.206
71669950|NCT02218463|142857314|SUPERIORITY|||||||0.0001|||||||ANOVA|||Time Effect||||0.0001
71669951|NCT02218463|142857314|SUPERIORITY|||||||0.37|||||||ANOVA|||Treatment Effect||||0.370
71786446|NCT03765918|143071470|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-2.81||||0.2485|TWO_SIDED|95.0|-7.59|1.97||Two-sided p-value based on cLDA model.|cLDA model|||||1.97|-7.59|0.2485
71786447|NCT03765918|143071471|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.|Difference in Least Square Means|-3.03||||0.1364|TWO_SIDED|95.0|-7.03|0.96||Two-sided p-value based on cLDA model.|cLDA model|||||0.96|-7.03|0.1364
71786448|NCT03765918|143071477|SUPERIORITY|Hazard ratio (HR) and associated 95% confidence interval (CI) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.73||||0.00411|TWO_SIDED|95.0|0.58|0.92|||Stratified Log Rank|One-sided p-value was based on log-rank test stratified by primary tumor site and tumor stage.||||0.92|0.58|0.00411
71669952|NCT02218463|142857314|SUPERIORITY|||||||0.425|||||||ANOVA|||Treatment by time interaction||||0.425
71786449|NCT03765918|143071478|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.66||||0.00217|TWO_SIDED|95.0|0.49|0.88|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.88|0.49|0.00217
71786450|NCT03765918|143071479|SUPERIORITY|HR and associated 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by primary tumor site and tumor stage.|Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.55|0.89|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by primary tumor site and tumor stage.||||0.89|0.55|0.00140
71786451|NCT00555321|143071528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.9|||||TWO_SIDED|95.0|16.1|49.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||49.8|16.1|
71786452|NCT00555321|143071528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.6|||||TWO_SIDED|95.0|9.6|43.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||43.5|9.6|
71786453|NCT00555321|143071528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|||||TWO_SIDED|95.0|14.8|48.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||48.5|14.8|
71786454|NCT00555321|143071528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-8.7|29.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||29.6|-8.7|
71786455|NCT00555321|143071528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-15.3|23.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||23.2|-15.3|
71786456|NCT00555321|143071528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-9.8|28.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||28.4|-9.8|
71786457|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.7|-12.9|
71786458|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-13.6|8.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||8.5|-13.6|
71786459|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||||TWO_SIDED|95.0|-23.8|1.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||1.5|-23.8|
71836657|NCT01566695|143179287|SUPERIORITY|||||||0.134|||||||Fisher Exact|||||||0.134
71669953|NCT02513160|142857326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|150.0|||<|0.0001|TWO_SIDED|95.0|86.8|213.2||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||213.2|86.8|<0.0001
71677177|NCT02989649|142872965|OTHER||Least Square Mean|-1.25|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-1.44|-1.05|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6||-1.05|-1.44|
71786460|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||||
71786461|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-12.1|11.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||11.3|-12.1|
71786462|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||||TWO_SIDED|95.0|-22.9|4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.1|-22.9|
71786463|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-12.9|
71786464|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||||TWO_SIDED|95.0|-18.1|5.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.4|-18.1|
71786465|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.1|||||TWO_SIDED|95.0|-38.9|-9.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-9.5|-38.9|
71786466|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-9.9|14.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||14.4|-9.9|
71786467|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-15.5|10.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||10.7|-15.5|
71786468|NCT00555321|143071529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|95.0|-35.5|-4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.1|-35.5|
71786469|NCT00555321|143071530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-14.5|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-14.5|
71786470|NCT00555321|143071530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-25.7|8.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||8.8|-25.7|
71786471|NCT00555321|143071530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-13.2|17.5|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||17.5|-13.2|
71786472|NCT00555321|143071530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|||||TWO_SIDED|95.0|-18.1|13.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||13.1|-18.1|
71786473|NCT00555321|143071530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-29.4|6.2|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||6.2|-29.4|
71786474|NCT00555321|143071530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-16.9|15.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||15.3|-16.9|
71786475|NCT00555321|143071531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.1|||||TWO_SIDED|95.0|15.8|50.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||50.6|15.8|
71786476|NCT00555321|143071531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.0|||||TWO_SIDED|95.0|11.4|46.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||46.3|11.4|
71677178|NCT00281632|142872970|SUPERIORITY_OR_OTHER||Reponse rate|31.0||||||95.0|16.3|48.1|||||50% Response Rate (Normalized and Non-Normalized)|||48.1|16.3|
71786477|NCT00555321|143071531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.2|||||TWO_SIDED|95.0|16.9|51.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||51.5|16.9|
71786478|NCT00555321|143071531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0|||||TWO_SIDED|95.0|-7.1|31.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||31.6|-7.1|
71786479|NCT00555321|143071531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||||TWO_SIDED|95.0|-11.5|27.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||27.2|-11.5|
71669954|NCT02513160|142857326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|144.0|||<|0.0001|TWO_SIDED|95.0|80.7|206.6||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.||206.6|80.7|<0.0001
71669955|NCT02513160|142857326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|148.0|||<|0.0001|TWO_SIDED|95.0|84.7|211.4||a priori threshold for significance of 0.05. The p-value was not adjusted.|ANCOVA|Difference of LS means and 95% CI represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|||211.4|84.7|<0.0001
71669956|NCT02513160|142857327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.9||||0.0003|TWO_SIDED|95.0|10.11|33.71||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Treatment comparisons began with am PEF for BAI 640 mcg/day vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BAI 640 mcg/day vs placebo 2) the am PEF for BAI 320 mcg/day vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.||33.71|10.11|0.0003
71669957|NCT02513160|142857327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|30.1|||<|0.0001|TWO_SIDED|95.0|18.33|41.9||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in previous analysis.||41.90|18.33|<0.0001
71669958|NCT02513160|142857327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.0||||0.0006|TWO_SIDED|95.0|9.14|32.83||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||32.83|9.14|0.0006
71669959|NCT02513160|142857328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|143.0|||<|0.0001|TWO_SIDED|95.0|71.7|214.1||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||214.1|71.7|<0.0001
71669960|NCT02513160|142857328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|170.0|||<|0.0001|TWO_SIDED|95.0|98.5|240.5||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||240.5|98.5|<0.0001
71669961|NCT02513160|142857328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|133.0||||0.0003|TWO_SIDED|95.0|61.3|204.3||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||204.3|61.3|0.0003
71677179|NCT00281632|142872974|SUPERIORITY_OR_OTHER||Response rate|17.6||||||95.0|3.8|43.4|||||Response rate (CR+PR)|||43.4|3.8|
71754047|NCT02491684|143011458|SUPERIORITY_OR_OTHER||LS Mean difference|0.11||||0.086|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.24|-0.02|0.086
71754048|NCT02491684|143011459|SUPERIORITY_OR_OTHER||LS Mean difference|11.69||||0.211|TWO_SIDED|95.0|-6.76|30.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||30.14|-6.76|0.211
71754049|NCT02491684|143011459|SUPERIORITY_OR_OTHER||LS Mean difference|11.19||||0.125|TWO_SIDED|95.0|-3.18|25.56|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||25.56|-3.18|0.125
71754050|NCT02491684|143011459|SUPERIORITY_OR_OTHER||LS Mean difference|11.14||||0.277|TWO_SIDED|95.0|-9.08|31.36|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||31.36|-9.08|0.277
71754051|NCT02491684|143011459|SUPERIORITY_OR_OTHER||LS Mean difference|17.13||||0.161|TWO_SIDED|95.0|-6.92|41.18|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||41.18|-6.92|0.161
71754052|NCT02491684|143011460|SUPERIORITY_OR_OTHER||LS Mean difference|0.06||||0.287|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.||0.16|-0.05|0.287
71754053|NCT02491684|143011460|SUPERIORITY_OR_OTHER||LS Mean difference|0.04||||0.457|TWO_SIDED|95.0|-0.06|0.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.||0.14|-0.06|0.457
71754054|NCT02491684|143011460|SUPERIORITY_OR_OTHER||LS Mean difference|0.05||||0.315|TWO_SIDED|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.||0.16|-0.05|0.315
71786480|NCT00555321|143071531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1|||||TWO_SIDED|95.0|-5.9|32.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|||32.6|-5.9|
71836658|NCT01566695|143179288|SUPERIORITY|||||||0.324|||||||Fisher Exact|||||||0.324
71836659|NCT01566695|143179289|SUPERIORITY|||||||0.442|||||||Fisher Exact|||||||0.442
71836660|NCT01566695|143179290|SUPERIORITY|||||||0.063|||||||Fisher Exact|||||||0.063
71836661|NCT01566695|143179291|SUPERIORITY|||||||0.198|||||||Fisher Exact|||||||0.198
71836662|NCT01566695|143179292|SUPERIORITY|||||||0.972|||||||Fisher Exact|||||||0.972
71836663|NCT01566695|143179293|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
71836664|NCT01566695|143179294|SUPERIORITY|||||||0.07|||||||Fisher Exact|||||||0.070
71669962|NCT02513160|142857329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.408|-0.64||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.640|-1.408|<0.0001
71677180|NCT00281632|142872974|SUPERIORITY_OR_OTHER||Response rate|21.1||||||95.0|6.1|45.6|||||Response rate (CR+PR)|||45.6|6.1|
71677181|NCT00281632|142872974|SUPERIORITY_OR_OTHER||Response rate|19.4||||||95.0|8.2|36.0|||||Response rate (CR+PR)|||36.0|8.2|
71836665|NCT01566695|143179295|SUPERIORITY|||||||0.436|||||||Fisher Exact|||||||0.436
71836666|NCT01566695|143179296|SUPERIORITY|||||||0.683|||||||Fisher Exact|||||||0.683
71836667|NCT03940963|143179330|NON_INFERIORITY|The visual analog scale (VAS, 0-100 scale) pain score change from baseline value to 12 months was tested for non-inferiority of neurectomy with Axoguard Nerve Cap to standard neurectomy alone using closed testing procedures.||||||0.011||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.011
71836668|NCT03940963|143179333|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.485||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.485
71836669|NCT03940963|143179334|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.259||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.259
71836670|NCT03940963|143179335|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.14||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.140
71836671|NCT03940963|143179336|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.544||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.544
71836672|NCT03940963|143179338|EQUIVALENCE|A predefined equivalence margin was not considered.||||||0.049||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||0.049
71836673|NCT04382404|143179354|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.63|1.15|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Velpatasvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 449.39 (77.12).||1.15|0.63|
71836674|NCT04382404|143179355|OTHER||Geometric mean ratio|1.19|||||TWO_SIDED|90.0|0.88|1.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of Sofosbuvir in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1226.16 (59.46).||1.60|0.88|
71836675|NCT04382404|143179356|OTHER||Geometric mean ratio|0.57|||||TWO_SIDED|90.0|0.49|0.67|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Maximum concentration of GS-331007 in plasma was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean concentration (percent coefficient of variation) for the non-pregnant cohort was 1312.17 (32.55).||0.67|0.49|
71836676|NCT04382404|143179357|OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.67|1.23|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|Area under the plasma concentration versus time curve tau of Velpatasvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 3570.65 (72.04).||1.23|0.67|
71836677|NCT04382404|143179358|OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|1.06|1.78||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 1483.83 (66.43).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|1.78|1.06|
71836678|NCT04382404|143179359|OTHER||Geometric mean ratio|0.62|||||TWO_SIDED|90.0|0.55|0.71||||||Area under the plasma concentration versus time curve tau of Sofosbuvir was compared between the 10 pregnant women in this study to 25 non-pregnant historical control women. The geometric mean (percent coefficient of variation) for the non-pregnant cohort was 15361.31 (22.35).|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|0.71|0.55|
71836679|NCT04382404|143179360|OTHER||Geometric mean ratio|1.43|||||TWO_SIDED|95.0|0.91|2.25||||||The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.|The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|2.25|0.91|
71845457|NCT02350634|143205255|OTHER||Correlation coefficient|0.429|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
71845458|NCT02350634|143205256|OTHER||Correlation coefficient|0.681|||<|0.001|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||<0.001
71845459|NCT02350634|143205257|OTHER||Correlation coefficient|0.644||||0.00278|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.00278
71754055|NCT02491684|143011460|SUPERIORITY_OR_OTHER||LS Mean difference|0.09||||0.134|TWO_SIDED|95.0|-0.03|0.22|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.||0.22|-0.03|0.134
71754056|NCT01436149|143011474|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.96||0.883|TWO_SIDED|95.0|-1.7|2.0|||Mixed- effects Model for Repeat Measures|||||2.0|-1.7|0.883
71754057|NCT01436149|143011475|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.69||0.576|TWO_SIDED|95.0|-1.8|1.0|||Mixed- effects Model for Repeat Measures|||||1.0|-1.8|0.576
71754058|NCT00894803|143011494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|an exact logistic regression was used due to the number of events|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
71754059|NCT00894803|143011495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.23|TWO_SIDED|95.0|0.7|4.31|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.31|0.70|0.23
71754060|NCT00894803|143011495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.53|TWO_SIDED|95.0|0.51|3.71|||Regression, Logistic|adjusting for age, baseline NIHSS score and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.71|0.51|0.53
71754061|NCT00894803|143011497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15||||0.053|TWO_SIDED|95.0|0.01|1.4|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||1.40|0.01|0.053
71754062|NCT00894803|143011498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.76||95.0|0.35|8.02|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||8.02|0.35|0.76
71754063|NCT00894803|143011499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to small number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
71754064|NCT00894803|143011500|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.99999|TWO_SIDED|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.92|0.24|0.99999
71754065|NCT00894803|143011501|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.78|TWO_SIDED|95.0|0.38|5.76|||Regression, Logistic|Exact methods used due t number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.76|0.38|0.78
71754066|NCT00894803|143011502|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.99999|TWO_SIDED|95.0|0.26|4.18|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.18|0.26|0.99999
71786481|NCT00555321|143071532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.6|||||TWO_SIDED|95.0|-5.8|36.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.8|-5.8|
71754067|NCT00894803|143011503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.35|TWO_SIDED|95.0|0.63|3.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.67|0.63|0.35
71754068|NCT00894803|143011503|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|3.02|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.02|0.40|0.85
71677182|NCT01369108|142872994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||null hypothesis no difference in anatomic form||||0.8
71754069|NCT00894803|143011504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.3|TWO_SIDED|95.0|0.65|3.88|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.88|0.65|0.30
71754070|NCT00894803|143011504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.73|TWO_SIDED|95.0|0.44|3.24|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||3.24|0.44|0.73
71754071|NCT00894803|143011505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.61|4.99|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.99|0.61|0.31
71754072|NCT00894803|143011506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.55|TWO_SIDED|95.0|0.47|4.07|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||4.07|0.47|0.55
71754073|NCT00894803|143011507|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.46|2.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||2.67|0.46|0.82
71754074|NCT00894803|143011508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.07|TWO_SIDED|95.0|0.9|6.64|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||6.64|0.90|0.07
71754075|NCT00894803|143011508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.22|TWO_SIDED|95.0|0.67|5.88|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator|||5.88|0.67|0.22
71754076|NCT01075243|143011526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.71||||0.0009|TWO_SIDED|95.0|1.53|5.89|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.||5.89|1.53|0.0009
71754077|NCT01075243|143011526|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.33|||<|0.0001|TWO_SIDED|95.0|8.66|14.0|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 1000 mg caplet and placebo caplet.||14.00|8.66|<0.0001
71786482|NCT00555321|143071532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|-6.0|38.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||38.0|-6.0|
71669963|NCT02513160|142857329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.482|-0.717||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.717|-1.482|<0.0001
71836680|NCT04382404|143179361|OTHER||Geometric mean ratio|1.91|||||TWO_SIDED|95.0|1.14|3.19|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||3.19|1.14|
71836681|NCT04382404|143179362|OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|95.0|0.87|2.6|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in peripheral blood mononuclear cells was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 1474 (488, 4453) fmol /10\^6 cells in the nonpregnant cohort.||2.60|0.87|
71836682|NCT04382404|143179363|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.5|0.56|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.56|.50|
71669964|NCT02513160|142857329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.415|-0.643||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.643|-1.415|<0.0001
71754078|NCT01075243|143011526|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.63|||<|0.0001||95.0|4.94|10.31|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID\^6h between Paracetamol 650 mg caplet and placebo caplet.||10.31|4.94|<0.0001
71754079|NCT03094416|143011556|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.783797|STANDARD_ERROR_OF_MEAN|0.158271|<|0.0001|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||<0.0001
71754080|NCT03094416|143011557|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.037312|STANDARD_ERROR_OF_MEAN|0.026128||0.1607|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.1607
71754081|NCT03094416|143011558|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|3.397559|STANDARD_ERROR_OF_MEAN|4.174962||0.4204|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4204
71754082|NCT03094416|143011559|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.055199|STANDARD_ERROR_OF_MEAN|0.019171||0.0062|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0062
71754083|NCT03094416|143011560|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|0.100127|STANDARD_ERROR_OF_MEAN|0.048171||0.0438|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0438
71754084|NCT03094416|143011561|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.216479|STANDARD_ERROR_OF_MEAN|0.093366||0.0254|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0254
71836683|NCT04382404|143179364|OTHER||Geometric mean ratio|0.53|||||TWO_SIDED|95.0|0.49|0.58|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.58|.49|
71677183|NCT01369108|142872994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89|||||||ANOVA|||null hypothesis no difference in margin adaptation||||0.89
71836684|NCT04382404|143179365|OTHER||Geometric mean ratio|0.55|||||TWO_SIDED|95.0|0.48|0.64|||||The pregnant cohort was the numerator, and the non-pregnant cohort was the denominator.|The geometric mean (95 percent confidence interval) concentration of GS-461203 in dried blood spots was compared between the pregnant cohort and 58 nonpregnant persons. The geometric mean (95 percent confidence interval) concentration of GS-461203 was 647 (571, 723) fmol/punch in the nonpregnant cohort.||.64|.48|
71845460|NCT02350634|143205258|OTHER||Correlation coefficient|0.437||||0.12|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.12
71836685|NCT02960893|143179390|SUPERIORITY||LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.519|TWO_SIDED|95.0|-0.5|0.9||Significance was evaluated at a 2-sided alpha level of 0.05|Mixed Model with Repeated Measures|Fixed effects: treatment, baseline (BL) gait severity, visit, treatment-by-visit interaction; Covariate: BL Total SARA score; Random effect: subject||||0.9|-0.5|0.519
71836686|NCT05687916|143179401|SUPERIORITY||LS Mean Difference Estimate|-0.24|STANDARD_ERROR_OF_MEAN|3.277|=|0.989|TWO_SIDED|95.0|-6.67|6.18||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||6.18|-6.67|=0.989
71836687|NCT05687916|143179401|SUPERIORITY||LS Mean Difference Estimate|2.4|STANDARD_ERROR_OF_MEAN|3.227|=|0.916|TWO_SIDED|95.0|-3.93|8.72||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||8.72|-3.93|=0.916
71836688|NCT05687916|143179402|SUPERIORITY||LS Mean Difference Estimate|-0.32|STANDARD_ERROR_OF_MEAN|1.656|=|0.989|TWO_SIDED|95.0|-3.57|2.92||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.|LS in LS Mean Difference denotes least squares.|||2.92|-3.57|=0.989
71836689|NCT05687916|143179402|SUPERIORITY||LS Mean Difference Estimate|-3.06|STANDARD_ERROR_OF_MEAN|1.59|=|0.216|TWO_SIDED|95.0|-6.18|0.06||The analysis used a linear MMRM with fixed effects for Baseline, age, prior use of narcolepsy medications, treatment, visit, and treatment-by-visit interaction as covariates. Reported p-value is adjusted for multiplicity.|MMRM|An unstructured variance-covariance structure was used.||||0.06|-6.18|=0.216
71669965|NCT02513160|142857330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.44|-0.203||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.203|-0.440|<0.0001
71669966|NCT02513160|142857330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.365|-0.128||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.||-0.128|-0.365|<0.0001
71669967|NCT02513160|142857330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.423|-0.185||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.||-0.185|-0.423|<0.0001
71836690|NCT01809691|143179409|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.08|TWO_SIDED|95.0|0.72|1.02|||Regression, Cox|||||1.02|0.72|.080
71836691|NCT01809691|143179410|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.51|0.67|||Regression, Cox|||||0.67|0.51|<0.001
71836692|NCT03892616|143179438|OTHER||Ratio of adjusted geometric means [%]|97.4|||||TWO_SIDED|90.0|82.3|115.3|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||115.3|82.3|
71669968|NCT02513160|142857331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|||||||Log Rank|||||||0.0058
71836693|NCT03892616|143179438|OTHER||Ratio of adjusted geometric means [%]|183.0|||||TWO_SIDED|90.0|154.0|217.4|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||217.4|154.0|
71836694|NCT03892616|143179438|OTHER||Ratio of adjusted geometric means [%]|114.8|||||TWO_SIDED|90.0|96.5|136.6|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||136.6|96.5|
71845461|NCT02350634|143205259|OTHER||Correlation coefficient|0.324||||0.0712|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0712
71669969|NCT02513160|142857331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||Log Rank|||||||0.0014
71669970|NCT02513160|142857331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|||||||Log Rank|||||||0.0062
71669971|NCT03593473|142857333|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -40 minutes.||||0.37
71669972|NCT03593473|142857333|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at -20 minutes.||||0.40
71669973|NCT03593473|142857333|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 0 minutes.||||0.63
71669974|NCT03593473|142857333|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 10 minutes.||||0.72
71669975|NCT03593473|142857333|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 15 minutes.||||0.88
71669976|NCT03593473|142857333|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 28 minutes.||||0.85
71669977|NCT03593473|142857333|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 38 minutes.||||0.72
71836695|NCT03892616|143179438|OTHER||Ratio of adjusted geometric means [%]|66.5|||||TWO_SIDED|90.0|55.5|79.5|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 25.44|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||79.5|55.5|
71836696|NCT03892616|143179439|OTHER||Ratio of adjusted geometric means [%]|60.2|||||TWO_SIDED|90.0|55.3|65.5|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.5|55.3|
71836697|NCT03892616|143179439|OTHER||Ratio of adjusted geometric means [%]|71.5|||||TWO_SIDED|90.0|65.6|78.0|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||78.0|65.6|
71836698|NCT03892616|143179439|OTHER||Ratio of adjusted geometric means [%]|177.9|||||TWO_SIDED|90.0|162.8|194.3|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||194.3|162.8|
71836699|NCT03892616|143179439|OTHER||Ratio of adjusted geometric means [%]|152.9|||||TWO_SIDED|90.0|139.5|167.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.65|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||167.7|139.5|
71836700|NCT03892616|143179440|OTHER||Ratio of adjusted geometric means [%]|60.3|||||TWO_SIDED|90.0|55.4|65.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||65.7|55.4|
71836701|NCT03892616|143179440|OTHER||Ratio of adjusted geometric means [%]|71.1|||||TWO_SIDED|90.0|65.2|77.6|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.6|65.2|
71669978|NCT03593473|142857333|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||T-test comparing mean cortisol by study arm at 48 minutes.||||0.57
71836702|NCT03892616|143179440|OTHER||Ratio of adjusted geometric means [%]|175.8|||||TWO_SIDED|90.0|160.8|192.2|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||192.2|160.8|
71836703|NCT03892616|143179440|OTHER||Ratio of adjusted geometric means [%]|150.2|||||TWO_SIDED|90.0|136.9|164.7|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 12.70|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||164.7|136.9|
71836704|NCT03892616|143179441|OTHER||Ratio of adjusted geometric means [%]|56.5|||||TWO_SIDED|90.0|51.8|61.7|||||The ratio was calculated as adjusted geometric mean of TF2a fasted (C) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||61.7|51.8|
71669979|NCT03593473|142857333|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. Times are restricted to times 0, +10, +15, and +28, which reflect the measures taken during the Trier Social Stress Test. The p-value presented below is for the interaction term between time and study arm.||||0.96
71836705|NCT03892616|143179441|OTHER||Ratio of adjusted geometric means [%]|70.5|||||TWO_SIDED|90.0|64.4|77.1|||||The ratio was calculated as adjusted geometric mean of TF2b fasted (E) as numerator and adjusted geometric mean of TF1 fed (A) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||77.1|64.4|
71669980|NCT03593473|142857334|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -40 minutes.||||0.71
71669981|NCT03593473|142857334|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at -20 minutes.||||0.92
71836706|NCT03892616|143179441|OTHER||Ratio of adjusted geometric means [%]|185.3|||||TWO_SIDED|90.0|169.4|202.8|||||The ratio was calculated as adjusted geometric mean of TF2a fed (B) as numerator and adjusted geometric mean of TF2a fasted (C) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||202.8|169.4|
71836707|NCT03892616|143179441|OTHER||Ratio of adjusted geometric means [%]|158.4|||||TWO_SIDED|90.0|144.3|173.9|||||The ratio was calculated as adjusted geometric mean of TF2b fed (D) as numerator and adjusted geometric mean of TF2b fasted (E) as denominator, \*100. Intra-individual geometric coefficient of variation (gCV \[%\]) = 13.02|Relative bioavailability: ratio of adjusted geometric means was calculated using an analysis of variance (ANOVA). The model on logarithmic scale included random effect of 'subjects within sequences' and fixed effect of 'sequence or block', 'period', 'treatment'.||173.9|144.3|
71836708|NCT01787383|143179462|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.13
71836709|NCT01787383|143179463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|TWO_SIDED||||||Regression, Logistic|||||||0.34
71836710|NCT01787383|143179464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|TWO_SIDED||||||Regression, Logistic|||||||0.088
71836711|NCT01787383|143179465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.20
71836712|NCT01787383|143179466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
71836713|NCT01787383|143179467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.033
71836714|NCT01787383|143179468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.37
71836715|NCT01787383|143179469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.66
71669982|NCT03593473|142857334|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 0 minutes.||||0.92
71669983|NCT03593473|142857334|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 10 minutes.||||0.40
71836716|NCT04533347|143179470|SUPERIORITY|||||||0.1879|TWO_SIDED|95.0|||||Fisher Exact|||Assuming an 85% clinical recovery rate in the TQ group and a 70% clinical recovery rate in the placebo group, sample sizes of 125 per treatment group were expected to achieve 80% power with a two-sided alpha of 0.05.||||0.1879
71836717|NCT03562377|143179482|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|-4.1|||||TWO_SIDED|95.0|-11.3|3.1|||Mantel Haenszel|||||3.1|-11.3|
71836718|NCT03562377|143179483|NON_INFERIORITY|The difference in response rates was calculated using the Mantel-Haenszel estimate of the risk difference stratified by baseline disease severity together with the 2-sided 95% CI. Non-inferiority of tralokinumab was demonstrated if the lower limit of the 95% CI was greater than -25%. Power calculation assumed 160 subjects in the per protocol analysis set, providing 98% power to establish non-inferiority, assuming response rates of 80% in both treatment groups and a non-inferiority margin of -25%|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-9.2|12.8|||Mantel Haenszel|||||12.8|-9.2|
71669984|NCT03593473|142857334|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 15 minutes.||||0.97
71669985|NCT03593473|142857334|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 28 minutes.||||0.71
71836719|NCT03562377|143179484|SUPERIORITY||Risk Difference (RD)|11.4||||0.049|TWO_SIDED|95.0|0.2|22.6||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||22.6|0.2|0.049
71836720|NCT03562377|143179485|SUPERIORITY||Risk Difference (RD)|12.7||||0.057|TWO_SIDED|95.0|-0.2|25.7||The p-value was adjusted for multiplicity by a pre-specified testing hierarchy. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.|Cochran-Mantel-Haenszel|The difference in response rates was analysed using the Cochran-Mantel-Haenszel test stratified by baseline disease severity (moderate or severe).||||25.7|-0.2|0.057
71836721|NCT03958955|143179592|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having an IGA score of 0 (clear) or 1 (almost clear) at Week 6.|||0.09|-0.37|0.4531
71836722|NCT03958955|143179595|SUPERIORITY||Attributable risk|0.07||||0.5|TWO_SIDED|95.0|-0.02|0.17||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success (i.e. no lesion-specific treatment-related AEs) of delgocitinib compared to vehicle. Exact p-value of McNemar's test.|||0.17|-0.02|0.5000
71836723|NCT03958955|143179596|SUPERIORITY||Attributable risk|-0.14||||0.4531|TWO_SIDED|95.0|-0.37|0.09||Exact p-value of McNemar's test.|McNemar||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib vs vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|||0.09|-0.37|0.4531
71836724|NCT03958955|143179597|SUPERIORITY||Attributable risk|0.0||||1|TWO_SIDED|95.0|-0.22|0.22||Exact p-value of McNemar's test.|McNemar||||Attributable risk is defined as the difference in estimated probability of treatment success of delgocitinib compared to vehicle. Exact p-value of McNemar's test. Success is defined as having at least a 2-point reduction in IGA score from baseline to Week 6.|0.22|-0.22|1.0000
71836725|NCT03958955|143179598|SUPERIORITY|||||||0.5797||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|Erythema is scored as 0=absent, 1=pink, faint, 2=red, 3=dark red, purple/violaceous/crusted/haemorrhagic. P-value of the Wilcoxon signed rank test.||||||0.5797
71754085|NCT03094416|143011562|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.011187|STANDARD_ERROR_OF_MEAN|0.036679||0.7619|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.7619
71754086|NCT03094416|143011563|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.121537|STANDARD_ERROR_OF_MEAN|0.064264||0.0655|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0655
71754087|NCT03094416|143011564|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.031636|STANDARD_ERROR_OF_MEAN|0.053033||0.5542|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5542
71754088|NCT03094416|143011565|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.019322|STANDARD_ERROR_OF_MEAN|0.046827||0.682|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.6820
71754089|NCT03094416|143011566|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|-0.049243|STANDARD_ERROR_OF_MEAN|0.024025||0.0468|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0468
71754090|NCT03094416|143011567|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.213171|STANDARD_ERROR_OF_MEAN|0.088103||0.0203|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.0203
71754091|NCT03094416|143011568|OTHER|"A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).~Normal distribution of data was tested with Shapiro Wilks. No data transformation was done."|Mean Difference (Final Values)|-0.030904|STANDARD_ERROR_OF_MEAN|0.038699||0.4291|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.4291
71754092|NCT03094416|143011569|OTHER|Normal distribution of data was tested with Shapiro Wilks. Data were log transformed. A mixed model ANCOVA repeated measures model was used to test differences in means at Visit 4 vs baseline on original data. As covariates the following baseline variables were considered: Age, Sex, BMI and the prescribed Tirosint dosage (dose/Kg).|Mean Difference (Final Values)|0.025502|STANDARD_ERROR_OF_MEAN|0.047802||0.5967|TWO_SIDED|||||level of significance p-value \< 0.05|Mixed Models Analysis|||||||0.5967
71754093|NCT03474588|143011599|SUPERIORITY|||||||0.3||||||Presented is the p value for the interaction between time and treatment.|Regression, Linear|Random Effects Regression Models (RERM), time was log transformed to account for expectation of greater change closer to baseline||||||0.30
71754094|NCT03474588|143011600|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.14|TWO_SIDED|95.0|-0.46|3.24||presented is the p value for the interaction of treatment and time in the model.|Regression, Linear|||Random Effects Regression Model (RERM), included in the model were treatment, time and the interaction of time and treatment.||3.24|-0.46|0.14
71754095|NCT03474588|143011601|SUPERIORITY|||||||0.097|||||||ANOVA|||||||0.097
71754096|NCT03474588|143011602|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
71754097|NCT01607957|143011603|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.81|||Stratified log-rank test|||||0.81|0.58|<0.0001
71754098|NCT01607957|143011604|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001|TWO_SIDED|95.0|0.41|0.57|||Stratified log-rank test|||||0.57|0.41|<0.0001
71754099|NCT00498940|143011613|SUPERIORITY_OR_OTHER|||||||0.14||||||Differences in cardiac index between groups were assessed by an independent 2-sample t test.|t-test, 2 sided|||||||.14
71669986|NCT03593473|142857334|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 38 minutes.||||0.78
71754100|NCT04607005|143011619|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.067|TWO_SIDED|95.0|-0.89|0.03||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||0.03|-0.89|0.067
71754101|NCT04607005|143011620|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.043|TWO_SIDED|95.0|-0.92|-0.02||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.02|-0.92|0.043
71754102|NCT04607005|143011621|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.003|TWO_SIDED|95.0|-2.37|-0.5||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.50|-2.37|0.003
71786483|NCT00555321|143071532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|||||TWO_SIDED|95.0|-16.6|26.8|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.8|-16.6|
71669987|NCT03593473|142857334|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||T-test comparing mean ACTH by study arm at 48 minutes.||||0.63
71754103|NCT04607005|143011622|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.002|TWO_SIDED|95.0|-2.35|-0.51||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.51|-2.35|0.002
71754104|NCT04607005|143011623|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.003|TWO_SIDED|95.0|-2.52|-0.55||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.55|-2.52|0.003
71786484|NCT00555321|143071532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||||TWO_SIDED|95.0|-10.8|36.1|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||36.1|-10.8|
71669988|NCT03593473|142857334|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol as the outcome variable with time, study arm, and an interaction between time and study arm as the exposure variables. This is the p-value for the interaction term between time and study arm.||||0.11
71669989|NCT03593473|142857335|SUPERIORITY|||||||0.07|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -40 minutes and Cortisol at -20 minutes.||||0.07
71669990|NCT03593473|142857335|SUPERIORITY|||||||0.22|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at -20 minutes and Cortisol at 0 minutes.||||0.22
71754105|NCT04607005|143011624|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.51|-0.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.57|-2.51|0.002
71754106|NCT04607005|143011625|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.012|TWO_SIDED|95.0|-2.9|-0.37||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.37|-2.90|0.012
71754107|NCT04607005|143011626|SUPERIORITY||Mean Difference (Final Values)|-1.67||||0.009|TWO_SIDED|95.0|-2.93|-0.42||p-Value was based on a ANCOVA Model.|ANCOVA|||||-0.42|-2.93|0.009
71754108|NCT04607005|143011627|SUPERIORITY||Mean Difference (Final Values)|-1.17||||0.005|TWO_SIDED|95.0|-1.99|-0.35||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.35|-1.99|0.005
71754109|NCT04607005|143011628|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.004|TWO_SIDED|95.0|-2.02|-0.4||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.40|-2.02|0.004
71754110|NCT04607005|143011629|SUPERIORITY||Mean Difference (Final Values)|-10.63||||0.01|TWO_SIDED|95.0|-18.68|-2.57||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-2.57|-18.68|0.010
71754111|NCT04607005|143011630|SUPERIORITY||Mean Difference (Final Values)|-11.39||||0.004|TWO_SIDED|95.0|-19.19|-3.6||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-3.60|-19.19|0.004
71754112|NCT04607005|143011631|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.009|TWO_SIDED|95.0|-1.43|-0.21||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.21|-1.43|0.009
71754113|NCT04607005|143011632|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.004|TWO_SIDED|95.0|-1.49|-0.28||p-Value was based on a mixed model repeated measures (MMRM) Model.|Mixed Models Analysis|||||-0.28|-1.49|0.004
71754114|NCT04607005|143011633|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.026|TWO_SIDED|95.0|0.26|0.92||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.92|0.26|0.026
71754115|NCT04607005|143011634|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.018|TWO_SIDED|95.0|0.25|0.88||p-Value was based on Cox Proportional Hazards Model.|Cox proportional hazards model|||||0.88|0.25|0.018
71786485|NCT00555321|143071532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|||||TWO_SIDED|95.0|-10.9|37.3|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||37.3|-10.9|
71754116|NCT03919773|143011637|SUPERIORITY|||||||0.629|||||||Kruskal-Wallis|||Intention-to-treat analysis||||0.629
71786486|NCT00555321|143071532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-21.8|26.0|||||For 95% CI of difference, normal approximation was used if N\>=5 in both arms. Otherwise exact method was used.|||26.0|-21.8|
71786487|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|||||TWO_SIDED|95.0|-6.7|43.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||43.3|-6.7|
71669991|NCT03593473|142857335|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at 0 minutes and Cortisol at +10 minutes.||||0.14
71669992|NCT03593473|142857335|SUPERIORITY|||||||0.14|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +10 minutes and Cortisol at +15 minutes.||||0.14
71669993|NCT03593473|142857335|SUPERIORITY|||||||0.05|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +15 minutes and Cortisol at +28 minutes.||||0.05
71669994|NCT03593473|142857335|SUPERIORITY|||||||0.1|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +28 minutes and Cortisol at +38 minutes.||||0.10
71754117|NCT03919773|143011638|SUPERIORITY|||||||0.718|||||||Fisher Exact|||comparison of proportion with positive treatment response (as defined) in IVIG group compared to albumin||||0.718
71754118|NCT02977403|143011639|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for AB reaction time measures. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. AB reaction times were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-1.948|||||TWO_SIDED|95.0|-20.79|16.894||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in AB, change scores were computed (post-pre = delta). Positive scores represent an increase in AB from pre- to post- intervention. Negative ∆reaction time scores represent a decrease in AB from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in AB following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||16.894|-20.790|
71754119|NCT02977403|143011639|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.952|||||TWO_SIDED|95.0|-35.28|33.377||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||33.377|-35.280|
71786488|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-21.6|25.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||25.5|-21.6|
71786489|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-20.1|28.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||28.7|-20.1|
71786490|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-21.2|32.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||32.1|-21.2|
71891906|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-12.3|||||TWO_SIDED|95.0|-18.6|-6.1||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-6.1|-18.6|
71891907|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-25.3|||||TWO_SIDED|95.0|-31.7|-19.0||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-19.0|-31.7|
71891908|NCT03193866|143305379|SUPERIORITY||Difference in proportion|-29.5|||||TWO_SIDED|95.0|-38.2|-20.8||||||Data shown are adjusted difference in proportion, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-20.8|-38.2|
71891909|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.07|0.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.00|-0.07|
71891910|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.09|
71891911|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.03|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.03|
71669995|NCT03593473|142857335|SUPERIORITY|||||||0.9|||||||Fisher's Z test|||Fisher's Z test for correlation between ACTH at +38 minutes and Cortisol at +48 minutes.||||0.90
71754120|NCT02977403|143011640|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficent|0.047|||||TWO_SIDED|95.0|-0.025|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.025|
71754121|NCT02977403|143011640|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.134|||||TWO_SIDED|95.0|-0.288|0.019||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.019|-0.288|
71786491|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||||TWO_SIDED|95.0|-36.0|14.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||14.2|-36.0|
71786492|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||||TWO_SIDED|95.0|-34.6|17.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.3|-34.6|
71786493|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-18.8|35.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||35.1|-18.8|
71891912|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.05||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.05|-0.03|
71669996|NCT03593473|142857335|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||A mixed effects model with random intercept and slope was used to model cortisol at time j+1 as the outcome with ACTH at time j, study arm, and an interaction term between ACTH at time j and study arm as the exposure variables. The p-value presented below is for the interaction term between ACTH at time j and study arm.||||0.21
71669997|NCT03593473|142857336|SUPERIORITY|||||||0.8441|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -40 to -35||||0.8441
71669998|NCT03593473|142857336|SUPERIORITY|||||||0.7919|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -35 to -30||||0.7919
71786494|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|||||TWO_SIDED|95.0|-46.3|6.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.3|-46.3|
71786495|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4|||||TWO_SIDED|95.0|-48.2|5.2|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.2|-48.2|
71786496|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|||||TWO_SIDED|95.0|-5.2|48.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||48.4|-5.2|
71786497|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-32.9|19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.8|-32.9|
71786498|NCT00555321|143071556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9|||||TWO_SIDED|95.0|-34.8|18.7|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||18.7|-34.8|
71786499|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||||TWO_SIDED|95.0|-42.4|26.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||26.3|-42.4|
71786500|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||||TWO_SIDED|95.0|-49.2|19.0|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||19.0|-49.2|
71786501|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.8|||||TWO_SIDED|95.0|-81.6|-19.8|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-19.8|-81.6|
71786502|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||16.9|-55.9|
71786503|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1|||||TWO_SIDED|95.0|-62.6|9.4|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||9.4|-62.6|
71786504|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.7|||||TWO_SIDED|95.0|-94.0|-33.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12||-33.1|-94.0|
71786505|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-32.6|34.3|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||34.3|-32.6|
71786506|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|||||TWO_SIDED|95.0|-47.4|20.6|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||20.6|-47.4|
71786507|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.5|||||TWO_SIDED|95.0|-72.6|0.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||0.5|-72.6|
71786508|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-41.1|31.1|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||31.1|-41.1|
71786509|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|||||TWO_SIDED|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||16.9|-55.9|
71786510|NCT00555321|143071557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.5|||||TWO_SIDED|95.0|-81.9|-3.5|||||For 95% CI of difference, normal approximation was used if N \>= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock||-3.5|-81.9|
71786511|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-21.2|6.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||6.0|-21.2|
71669999|NCT03593473|142857336|SUPERIORITY|||||||0.5639|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -30 to -25||||0.5639
71670000|NCT03593473|142857336|SUPERIORITY|||||||0.3139|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -25 to -20||||0.3139
71670001|NCT03593473|142857336|SUPERIORITY|||||||0.4222|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -20 to -15||||0.4222
71670002|NCT03593473|142857336|SUPERIORITY|||||||0.834|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -15 to -10||||0.834
71786512|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||5.3|-18.2|
71786513|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-14.9|
71786514|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-25.1|7.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||7.1|-25.1|
71670003|NCT03593473|142857336|SUPERIORITY|||||||0.7562|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -10 to -5||||0.7562
71670004|NCT03593473|142857336|SUPERIORITY|||||||0.4245|||||||t-test, 2 sided|||High frequency heart rate variability at minutes -5 to 0||||0.4245
71786515|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||4.5|-15.6|
71786516|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||3.9|-12.7|
71786517|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
71786518|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||5.3|-18.2|
71786519|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-14.9|
71786520|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||||
71786521|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||4.5|-15.6|
71786522|NCT00555321|143071570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||3.9|-12.7|
71786523|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-25.6|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-25.6|
71836726|NCT03958955|143179599|SUPERIORITY|||||||0.7862||||||P-value of the Wilcoxon signed rank test.|Wilcoxon signed rank test|P-value of the Wilcoxon signed rank test.||Total skin disease activity score is the sum of the scores for erythema, scaling/hyperkeratosis, and oedema/infiltration. Total skin disease activity score ranges from 0 to 7 with lower score indicating better state.||||0.7862
71786524|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|-11.7|22.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||22.3|-11.7|
71786525|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-20.1|15.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||15.2|-20.1|
71786526|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-24.0|12.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||12.5|-24.0|
71786527|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-10.5|24.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||24.2|-10.5|
71786528|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-18.5|17.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||17.6|-18.5|
71836727|NCT04638829|143179601|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71836728|NCT04638829|143179602|OTHER|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
71836729|NCT04638829|143179603|OTHER|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71670005|NCT03593473|142857336|SUPERIORITY|||||||0.1425|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 5 to 8||||0.1425
71670006|NCT03593473|142857336|SUPERIORITY|||||||0.7175|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 13||||0.7175
71670007|NCT03593473|142857336|SUPERIORITY|||||||0.1417|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 13 to 18||||0.1417
71786529|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.3|9.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||9.4|-23.3|
71836730|NCT04638829|143179604|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71836731|NCT02807636|143179627|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0073|TWO_SIDED|95.0|0.7|0.96||inverse normal combination|Log Rank|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||0.96|0.70|0.0073
71836732|NCT02807636|143179628|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.023|TWO_SIDED|95.0|0.73|1.0||one-sided, inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.0|0.73|0.0230
71836733|NCT02807636|143179629|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.3968|TWO_SIDED|95.0|0.82|1.16|||Log Rank|one-sided||Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.16|0.82|0.3968
71836734|NCT02807636|143179634|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0373|TWO_SIDED|95.0|0.73|1.01||inverse normal combination|Regression, Cox|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||1.01|0.73|0.0373
71836735|NCT02807636|143179635|SUPERIORITY||Difference in Event Free Rate|5.0||||0.1509|TWO_SIDED|95.0|-1.82|11.81|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||11.81|-1.82|0.1509
71836736|NCT02807636|143179636|SUPERIORITY||Difference in Event Free Rate|3.36||||0.3761|TWO_SIDED|95.0|-4.08|10.79|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||10.79|-4.08|0.3761
71836737|NCT02807636|143179637|SUPERIORITY||Difference in Event Free Rate|-8.29||||0.0083|TWO_SIDED|95.0|-14.45|-2.13|||Z-test|||Stratification factors: Enrollment stage, PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.||-2.13|-14.45|0.0083
71836738|NCT02807636|143179638|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0542|TWO_SIDED|95.0|0.64|1.0|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.00|0.64|0.0542
71836739|NCT02807636|143179639|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6139|TWO_SIDED|95.0|0.74|1.19|||Log Rank|||Strata are: PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.19|0.74|0.6139
71836740|NCT02807636|143179640|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.554|TWO_SIDED|95.0|0.86|1.32|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.32|0.86|0.5540
71786530|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5|||||TWO_SIDED|95.0|-27.4|6.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||6.5|-27.4|
71786531|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|||||TWO_SIDED|95.0|-37.5|-2.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-2.7|-37.5|
71786532|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-15.5|19.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||19.7|-15.5|
71786533|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-19.4|16.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||16.9|-19.4|
71786534|NCT00555321|143071571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-29.3|7.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.9|-29.3|
71786535|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|-6.3|36.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||36.0|-6.3|
71836741|NCT02807636|143179641|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.0241|TWO_SIDED|95.0|1.03|1.62|||Log Rank|||Strata are: Enrollment Stage, PD-L1 Status, BAJORIN Risk Factor Score and Stratum 4 for all participants.||1.62|1.03|0.0241
71836742|NCT02807636|143179645|SUPERIORITY||Hazard Ratio (HR)|1.42||||1|TWO_SIDED|95.0|1.19|1.69|||Log Rank|||Stratification factors: PD-L1 status and Bajorin risk score/presence of liver metastases and investigator choice of chemotherapy.||1.69|1.19|1.0000
71836743|NCT04088630|143179655|SUPERIORITY|||||||0.0427||||||p\<0.05 considered significant. Between group pairwise comparisons performed with Bonferroni correction.|Fisher Exact|||Difference in proportion of subjects with cardiac events up to 30 days post-ictus tested between three groups.||||0.0427
71836744|NCT04088630|143179656|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Difference in proportion of subjects with nosocomial infections up to 90 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.19
71836745|NCT04088630|143179657|SUPERIORITY|||||||0.3|||||||Fisher Exact|||Difference in proportion of subjects with neurologic decline up to 30 days post-ictus tested between three groups. No pairwise comparisons performed.||||0.30
71670008|NCT03593473|142857336|SUPERIORITY|||||||0.0514|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 18 to 23||||0.0514
71836746|NCT05634226|143179691|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71836747|NCT05634226|143179692|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71836748|NCT02111798|143179701|SUPERIORITY|||||||0.889|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.889
71836749|NCT02111798|143179702|SUPERIORITY|||||||0.605|||||||Mixed Models Analysis|||Comparisons were conducted as a function of medication condition, collapsed across abstinence initiation and relapse prevention groups, according to a priori-stated statistical analysis.||||0.605
71836750|NCT05493787|143179703|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Active Control message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Active Control message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
71845462|NCT02350634|143205260|OTHER||Correlation coefficient|0.564||||0.0958|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.0958
71670009|NCT03593473|142857336|SUPERIORITY|||||||0.1507|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 23 to 28||||0.1507
71670010|NCT03593473|142857336|SUPERIORITY|||||||0.4204|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 8 to 33||||0.4204
71670011|NCT03593473|142857336|SUPERIORITY|||||||0.4209|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 33 to 38||||0.4209
71670012|NCT03593473|142857336|SUPERIORITY|||||||0.2569|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 38 to 43||||0.2569
71670013|NCT03593473|142857336|SUPERIORITY|||||||0.0828|||||||t-test, 2 sided|||High frequency heart rate variability at minutes 43 to 48||||0.0828
71670014|NCT03593473|142857337|SUPERIORITY|||||||0.6452|||||||t-test, 2 sided|||Pre-ejection period at minutes -40 to -35||||0.6452
71670015|NCT03593473|142857337|SUPERIORITY|||||||0.3228|||||||t-test, 2 sided|||Pre-ejection period at minutes -35 to -30||||0.3228
71670016|NCT03593473|142857337|SUPERIORITY|||||||0.3541|||||||t-test, 2 sided|||Pre-ejection period at minutes -30 to -25||||0.3541
71786536|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-23.4|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.2|-23.4|
71786537|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-23.4|10.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||10.0|-23.4|
71786538|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-22.0|23.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||23.4|-22.0|
71836751|NCT05493787|143179703|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Ease message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending an Ease message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
71670017|NCT03593473|142857337|SUPERIORITY|||||||0.4311|||||||t-test, 2 sided|||Pre-ejection period at minutes -25 to -20||||0.4311
71670018|NCT03593473|142857337|SUPERIORITY|||||||0.3349|||||||t-test, 2 sided|||Pre-ejection period at minutes -20 to -15||||0.3349
71670019|NCT03593473|142857337|SUPERIORITY|||||||0.2646|||||||t-test, 2 sided|||Pre-ejection period at minutes -15 to -10||||0.2646
71670020|NCT03593473|142857337|SUPERIORITY|||||||0.1095|||||||t-test, 2 sided|||Pre-ejection period at minutes -10 to -5||||0.1095
71670021|NCT03593473|142857337|SUPERIORITY|||||||0.0194|||||||t-test, 2 sided|||Pre-ejection period at minutes -5 to 0||||0.0194
71670022|NCT03593473|142857337|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||Pre-ejection period at minutes 5 to 8||||0.473
71670023|NCT03593473|142857337|SUPERIORITY|||||||0.5768|||||||t-test, 2 sided|||Pre-ejection period at minutes 8 to 13||||0.5768
71670024|NCT03593473|142857337|SUPERIORITY|||||||0.3477|||||||t-test, 2 sided|||Pre-ejection period at minutes 13 to 18||||0.3477
71670025|NCT03593473|142857337|SUPERIORITY|||||||0.1413|||||||t-test, 2 sided|||Pre-ejection period at minutes 18 to 23||||0.1413
71670026|NCT03593473|142857337|SUPERIORITY|||||||0.2128|||||||t-test, 2 sided|||Pre-ejection period at minutes 23 to 28||||0.2128
71670027|NCT03593473|142857337|SUPERIORITY|||||||0.1415|||||||t-test, 2 sided|||Pre-ejection period at minutes 28 to 33||||0.1415
71670028|NCT03593473|142857337|SUPERIORITY|||||||0.1126|||||||t-test, 2 sided|||Pre-ejection period at minutes 33 to 38||||0.1126
71670029|NCT03593473|142857337|SUPERIORITY|||||||0.1647|||||||t-test, 2 sided|||Pre-ejection period at minutes 38 to 43||||0.1647
71670030|NCT03593473|142857337|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||Pre-ejection period at minutes 43 to 48||||0.088
71670031|NCT02157935|142857365|SUPERIORITY_OR_OTHER||Rate ratio|0.76||||0.0059|TWO_SIDED|95.0|0.62|0.92|||Negative binomial model|||||0.92|0.62|0.0059
71670032|NCT02157935|142857366|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Regression, Cox|||||0.96|0.64|0.0164
71670033|NCT02157935|142857367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343||||0.007|TWO_SIDED|95.0|-2.318|-0.368|||Mixed Models Analysis|||||-0.368|-2.318|0.0070
71670034|NCT02157935|142857368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.0091|TWO_SIDED|95.0|0.008|0.053|||Mixed Models Analysis|||||0.053|0.008|0.0091
71670035|NCT02157935|142857369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.203||||0.0082|TWO_SIDED|95.0|-0.353|-0.053|||ANCOVA|||||-0.053|-0.353|0.0082
71670036|NCT02157935|142857370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.0048|TWO_SIDED|95.0|-0.048|-0.009|||ANCOVA|||||-0.009|-0.048|0.0048
71670037|NCT00572936|142857391|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for significance was \<0.05|ANOVA|||||||<.05
71670038|NCT00572936|142857392|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
71670039|NCT00572936|142857393|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.93||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.93
71670040|NCT00572936|142857394|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.84||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.84
71670041|NCT00572936|142857395|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was \<0.05|ANOVA|||||||<0.05
71670042|NCT00572936|142857396|EQUIVALENCE|ANOVA was performed to compare the results between the three interventions.||||||0.89||||||threshold for statistical significance was \<0.05|ANOVA|||||||0.89
71670043|NCT00572936|142857397|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences between outflow facility for the three interventions|||||<|0.05||||||threshold for statistical significance was \<0.05|Kruskal-Wallis|||||||<0.05
71836752|NCT05493787|143179703|SUPERIORITY||||||<|0.001||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent an Waiting for You message message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Waiting for You message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||<.001
71836753|NCT05493787|143179703|SUPERIORITY|||||||0.003||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Rare message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Rare Message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.003
71836754|NCT05493787|143179703|SUPERIORITY|||||||0.035||||||Comparisons between Passive Control and all other arms (Analyses 1-5) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Flu shot self-scheduling does not differ between those sent a Protect Yourself - Frequent message and those not sent a message (i.e., those in the Passive Control group); Alternative hypothesis: Sending a Protect Yourself - Frequent message increases self-scheduling compared with sending no message. Analysis combines across November and December send dates.||||.035
71836755|NCT05493787|143179703|SUPERIORITY|||||||0.593||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Ease messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Ease messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.593
71670044|NCT00572936|142857398|EQUIVALENCE|Kruskal-Wallis test was used to compare the differences in uveoscleral outflow between the three interventions|||||<|0.05||||||threshold for statistical analysis was \<0.05|Kruskal-Wallis|||||||<0.05
71786539|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|||||TWO_SIDED|95.0|-38.6|-0.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-0.1|-38.6|
71786540|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|||||TWO_SIDED|95.0|-39.1|-1.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6||-1.8|-39.1|
71786541|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|-8.7|34.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||34.0|-8.7|
71786542|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||||TWO_SIDED|95.0|-25.2|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||8.7|-25.2|
71786543|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||||TWO_SIDED|95.0|-26.3|7.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||7.7|-26.3|
71786544|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-24.5|21.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12.||21.1|-24.5|
71786545|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|||||TWO_SIDED|95.0|-40.5|-1.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-1.9|-40.5|
71786546|NCT00555321|143071578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|||||TWO_SIDED|95.0|-41.8|-4.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N \>= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12||-4.3|-41.8|
71786547|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.62|||||TWO_SIDED|90.0|-1.2|2.44||||||Comparison at 0.5 hours postdose.||2.44|-1.20|
71786548|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.89|||||TWO_SIDED|90.0|1.05|4.73||||||Comparison at 2.0 hours postdose.||4.73|1.05|
71786549|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.11|||||TWO_SIDED|90.0|0.28|3.95||||||Comparison at 3.0 hours postdose.||3.95|0.28|
71786550|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 4.0 hours postdose.||3.32|-0.36|
71786551|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.48|||||TWO_SIDED|90.0|-0.36|3.32||||||Comparison at 5.0 hours postdose.||3.32|-0.36|
71786552|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.48|||||TWO_SIDED|90.0|1.64|5.32||||||Comparison at 6.0 hours postdose.||5.32|1.64|
71786553|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.12|||||TWO_SIDED|90.0|0.27|3.97||||||Comparison at 8.0 hours postdose.||3.97|0.27|
71786554|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.67|||||TWO_SIDED|90.0|-0.17|3.51||||||Comparison at 12.0 hours postdose.||3.51|-0.17|
71786555|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.01|||||TWO_SIDED|90.0|-1.57|3.59||||||Comparison at 0.5 hours postdose.||3.59|-1.57|
71786556|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.99|||||TWO_SIDED|90.0|2.4|7.57||||||Comparison at 2.0 hours postdose.||7.57|2.40|
71786557|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.28|||||TWO_SIDED|90.0|3.71|8.86||||||Comparison at 3.0 hours postdose.||8.86|3.71|
71670045|NCT02547428|142857399|SUPERIORITY||Treatment difference|-8.1|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-11.0|-5.1|||ANCOVA||Sample size of 60 participants (30 per treatment sequence) was needed to provide minimum 85% power to detect 5 point difference between treatments at a 2-sided significance level of 5% using a paired t-test.|Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR and placebo. The analysis of covariance (ANCOVA) model included terms for period, sequence, and treatment as fixed effects, and Baseline score as a covariate, and a participate-within-sequence term as a random effect.||-5.1|-11.0|<0.001
71670046|NCT02547428|142857400|SUPERIORITY||Treatment difference|-7.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.001|TWO_SIDED|95.0|-10.7|-3.6|||ANCOVA|||Null hypothesis was that there was no difference in ADHD-RS-IV total score change from Baseline between CTN SR 400 mg/day and placebo.||-3.6|-10.7|<0.001
71670047|NCT01479465|142857421|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0395|TWO_SIDED|95.0|1.01|2.06|||Log Rank|||"The null hypothesis was that the hazard ratio (HR) equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% confidence interval \[CI\]) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level Eastern Cooperative Oncology Group (ECOG) performance status (0 or \> 0) at randomization."||2.06|1.01|0.0395
71670048|NCT01479465|142857421|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.1042|TWO_SIDED|95.0|0.92|1.89|||Log Rank|||"The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or \> 0) at randomization."||1.89|0.92|0.1042
71670049|NCT02806908|142857424|SUPERIORITY|||||||0.0022|||||||ANOVA|||||||0.0022
71670050|NCT02806908|142857425|SUPERIORITY|||||||0.0416|||||||ANOVA|||||||0.0416
71786558|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.35|||||TWO_SIDED|90.0|3.78|8.93||||||Comparison at 4.0 hours postdose.||8.93|3.78|
71786559|NCT01606436|143071621|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.71|||||TWO_SIDED|90.0|2.11|7.31||||||Comparison at 12.0 hours postdose.||7.31|2.11|
71670051|NCT02806908|142857426|SUPERIORITY|||||||0.0963|||||||McNemar|||||||0.0963
71670052|NCT02806908|142857427|SUPERIORITY|||||||0.3018|||||||McNemar|||||||0.3018
71670053|NCT02806908|142857428|SUPERIORITY|||||||0.424|||||||McNemar|||||||0.4240
71670054|NCT02806908|142857429|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
71670055|NCT02806908|142857430|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
71670056|NCT02806908|142857431|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71670057|NCT02806908|142857432|SUPERIORITY|||||||0.6291|||||||McNemar|||||||0.6291
71670058|NCT02806908|142857433|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71670059|NCT02806908|142857434|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71670060|NCT02806908|142857435|SUPERIORITY|||||||1|||||||McNemar|||||||1.0000
71670061|NCT02806908|142857436|SUPERIORITY|||||||0.7744|||||||McNemar|||||||0.7744
71670062|NCT02806908|142857437|SUPERIORITY|||||||0.7539|||||||McNemar|||||||0.7539
71670063|NCT02806908|142857438|SUPERIORITY|||||||0.1141|||||||ANOVA|||||||0.1141
71670064|NCT02806908|142857439|SUPERIORITY|||||||0.4441|||||||ANOVA|||||||0.4441
71754122|NCT02977403|143011641|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass and height, race and ethnicity.|beta coefficent|-0.002|||||TWO_SIDED|95.0|-0.085|0.082||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post-intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.082|-0.085|
71786560|NCT03334448|143071633|SUPERIORITY||Ratio of Geometric Least Square Means|0.83|||||TWO_SIDED|90.0|0.818|0.957||||||||0.957|0.818|
71786561|NCT03334448|143071634|SUPERIORITY||Ration of Lease Square Means|0.97|||||TWO_SIDED|90.0|0.83|1.09||||||||1.09|0.83|
71813119|NCT03720938|143128564|SUPERIORITY|||||||0.006602||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.||||0.006602
71670065|NCT02806908|142857440|SUPERIORITY|||||||0.3423|||||||ANOVA|||||||0.3423
71670066|NCT02806908|142857441|SUPERIORITY|||||||0.9384|||||||ANOVA|||||||0.9384
71670067|NCT02806908|142857442|SUPERIORITY|||||||0.0939|||||||ANOVA|||||||0.0939
71670068|NCT02806908|142857443|SUPERIORITY|||||||0.0246|||||||ANOVA|||||||0.0246
71670069|NCT02806908|142857444|SUPERIORITY|||||||0.1475|||||||ANOVA|||||||0.1475
71670070|NCT02806908|142857445|SUPERIORITY|||||||0.1513|||||||ANOVA|||||||0.1513
71670071|NCT02806908|142857446|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
71670072|NCT02806908|142857447|SUPERIORITY|||||||0.0005|||||||ANOVA|||||||0.0005
71670073|NCT02806908|142857448|SUPERIORITY|||||||0.4774|||||||ANOVA|||||||0.4774
71670074|NCT02806908|142857449|SUPERIORITY|||||||0.3801|||||||ANOVA|||||||0.3801
71670075|NCT02806908|142857450|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71670076|NCT01760304|142857451|SUPERIORITY|||||||0.769|||||||2-sided paired t-test|||a paired t-test was calculated comparing baseline measures and post intervention||||0.769
71670077|NCT01760304|142857451|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||paired T-test|||a paired t-test was calculated comparing baseline measures and post intervention||||<0.0001
71786562|NCT02850965|143071639|EQUIVALENCE|Protocol defined margins are: \[-18.0%, +18.0%\] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set.|Difference in PASI 75 Response Rate|-2.2|||||TWO_SIDED|95.0|-14.4|8.7|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|8.7|-14.4|
71786563|NCT02850965|143071640|OTHER|Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in PASI 75 Response Rate|2.9|||||TWO_SIDED|95.0|-8.5|12.6|||Regression, Logistic||Difference in PASI 75 Response Rate = (BI 695501 - US-licensed Humira, %).|The week 24 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.|12.6|-8.5|
71786564|NCT02850965|143071641|OTHER||Difference of Least Squares Means|1.7|||||TWO_SIDED|95.0|-2.7|6.0|||ANCOVA|Analysis of covariance (ANCOVA)|Difference of Least Squares Means (LSM)= LSM of (BI 695501 - Humira)|Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.||6.0|-2.7|
71786565|NCT02850965|143071642|OTHER|Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in sPGA <= 1 Response Rate|7.5|||||TWO_SIDED|95.0|-4.8|19.1|||Regression, Logistic||Difference in sPGA \<= 1 Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|19.1|-4.8|
71786566|NCT02850965|143071643|OTHER|Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in DLQI Response Rate|0.4|||||TWO_SIDED|95.0|-11.7|11.3|||Regression, Logistic||Difference in DLQI (0, 1) Response Rate = (BI 695501 - US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.|11.3|-11.7|
71786567|NCT01767155|143071645|OTHER||Kaplan-Meier|69.8|||||TWO_SIDED|95.0|63.6|75.1||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||75.1|63.6|
71786568|NCT01767155|143071645|OTHER||Kaplan-Meier|45.8|||||TWO_SIDED|95.0|39.5|52.0||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||52.0|39.5|
71786569|NCT01767155|143071645|OTHER||Kaplan-Meier|72.1|||||TWO_SIDED|95.0|66.0|77.3||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||77.3|66.0|
71786570|NCT01767155|143071645|OTHER||Kaplan-Meier|44.6|||||TWO_SIDED|95.0|38.2|50.7||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||50.7|38.2|
71786571|NCT01767155|143071645|OTHER||Hazard Ratio (HR)|1.06||||0.5441|TWO_SIDED|95.0|0.87|1.3|||Log Rank|2-sided||A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.||1.30|0.87|0.5441
71786572|NCT01767155|143071646|OTHER||Odds Ratio (OR)|0.87||||0.5907|TWO_SIDED|95.0|0.52|1.45|||Mantel Haenszel|2-sided test||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.||1.45|0.52|0.5907
71786573|NCT01767155|143071647|OTHER||Kaplan-Meier|46.7|||||TWO_SIDED|95.0|39.5|53.6||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months.||53.6|39.5|
71786574|NCT01767155|143071647|OTHER||Kaplan-Meier|20.6|||||TWO_SIDED|95.0|14.6|27.4||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||27.4|14.6|
71786575|NCT01767155|143071647|OTHER||Kaplan-Meier|47.5|||||TWO_SIDED|95.0|40.0|54.7||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months||54.7|40.0|
71786576|NCT01767155|143071647|OTHER||Kaplan-Meier|12.3|||||TWO_SIDED|95.0|6.9|19.3||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months||19.3|6.9|
71786577|NCT01767155|143071647|OTHER||Hazard Ratio (HR)|0.89||||0.3089|TWO_SIDED|95.0|0.71|1.11|||Log Rank|2-sided||Hypothesis testing between the two treatment arms was performed using a log rank test.||1.11|0.71|0.3089
71786578|NCT01767155|143071648|OTHER||Odds Ratio (OR)|1.07||||0.6924|TWO_SIDED|95.0|0.76|1.52|||Mantel Haenszel|2-sided||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.||1.52|0.76|0.6924
71786579|NCT00371137|143071653|SUPERIORITY_OR_OTHER||||||>|0.001||95.0|||||Chi-squared|||Overall Comparison||||>0.001
71786580|NCT00371137|143071653|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 4.5g||||<0.001
71786581|NCT00371137|143071653|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||Pairwise comparison of placebo and Xyrem 6.0g||||0.015
71670078|NCT01760304|142857453|SUPERIORITY_OR_OTHER||||||<|0.05|||||||paired t-test|||||||<0.05
71786582|NCT01753856|143071689|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
71786583|NCT01753856|143071690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in CC.|Fisher Exact|||||||<0.001
71786584|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||SL Only, in CC.|Fisher Exact|||||||0.002
71786585|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.494|TWO_SIDED|||||No Label, in CC.|Fisher Exact|||||||0.494
71786586|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||DL and SL, in EC.|Fisher Exact|||||||0.001
71670079|NCT04429503|142857454|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|Least Square (LS) Mean Difference|-0.57|||<|0.0001|TWO_SIDED|95.0|-2.26|1.13|||Mixed Model for Repeated Measurements||HDq12 minus 2q8|||1.13|-2.26|<0.0001
71670080|NCT04429503|142857454|NON_INFERIORITY|p-value for one-sided non-inferiority (NI) test at a margin of 4 letters|LS Mean Difference|-1.44||||0.0031|TWO_SIDED|95.0|-3.27|0.39|||Mixed Model for Repeated Measurements||HDq16 minus 2q8|||0.39|-3.27|0.0031
71670081|NCT04429503|142857455|NON_INFERIORITY|The non-inferiority margin was set at 15%|Adjusted Difference (%)|1.98|||||TWO_SIDED|95.0|-6.61|10.57|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||10.57|-6.61|
71677184|NCT01369108|142872994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||null hypothesis no difference in margin discoloration||||0.79
71754123|NCT02977403|143011641|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.053|||||TWO_SIDED|95.0|-0.177|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.177|
71754124|NCT02977403|143011642|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.08|||||TWO_SIDED|95.0|-0.022|0.182||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.182|-0.022|
71754125|NCT02977403|143011642|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.018|||||TWO_SIDED|95.0|-0.139|0.103||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.103|-0.139|
71754126|NCT02977403|143011643|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.086|0.113||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.113|-0.086|
71754127|NCT02977403|143011643|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.035|||||TWO_SIDED|95.0|-0.179|0.109||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.109|-0.179|
71754128|NCT02977403|143011644|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.083|||||TWO_SIDED|95.0|-0.001|0.167||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.167|-0.001|
71754129|NCT02977403|143011644|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.069|||||TWO_SIDED|95.0|-0.201|0.063||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.063|-0.201|
71758539|NCT02205736|143019222|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71786587|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED|||||SL Only, in EC.|Fisher Exact|||||||0.027
71786588|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.118|TWO_SIDED|||||No Label, in EC.|Fisher Exact|||||||0.118
71786589|NCT01753856|143071690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and SL, in IC.|Fisher Exact|||||||<0.001
71670082|NCT04429503|142857455|NON_INFERIORITY|The non-inferiority margin was set at 15%.|Adjusted Difference (%)|-7.52|||||TWO_SIDED|95.0|-16.88|1.84|||||Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors|||1.84|-16.88|
71670083|NCT05516108|142857476|OTHER|||||||0.004|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.004
71786590|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||SL Only, in IC.|Fisher Exact|||||||0.001
71786591|NCT01753856|143071690|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED|||||No Label, in IC.|Fisher Exact|||||||>0.999
71786592|NCT01753856|143071690|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL and SL, in PC.|Fisher Exact|||||||0.002
71786593|NCT01753856|143071690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SL Only, in PC.|Fisher Exact|||||||<0.001
71786594|NCT01753856|143071690|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No Label, in PC.|Fisher Exact|||||||<0.001
71786595|NCT01753856|143071691|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
71786596|NCT01753856|143071691|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
71786597|NCT01753856|143071691|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
71786598|NCT01753856|143071692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786599|NCT01753856|143071692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786600|NCT01753856|143071692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786601|NCT01753856|143071692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786602|NCT01753856|143071693|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Remodeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
71786603|NCT01753856|143071693|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||Modeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)|||||||0.740
71786604|NCT01753856|143071693|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Remodeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
71786605|NCT01753856|143071693|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Modeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)|||||||0.008
71786606|NCT01753856|143071693|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Remodeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
71786607|NCT01753856|143071693|SUPERIORITY_OR_OTHER|||||||0.661|TWO_SIDED|||||Modeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)|||||||0.661
71670084|NCT05516108|142857477|OTHER|||||||0.02|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.020
71670085|NCT05516108|142857478|OTHER|||||||0.74|||||||Mixed Models Analysis|Stata melogit||time (pre, post, follow-up) x condition (mindfulness, coping)||||.74
71670086|NCT05516108|142857479|OTHER|||||||0.1|||||||Mixed Models Analysis|||time (pre, post, follow-up) x condition (mindfulness, coping)||||.10
71786608|NCT01753856|143071695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786609|NCT01753856|143071695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786610|NCT01753856|143071695|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|||||PC.|Wilcoxon (Mann-Whitney)|||||||0.740
71786611|NCT01753856|143071696|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786612|NCT01753856|143071696|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
71786613|NCT01753856|143071696|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786614|NCT01753856|143071696|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.850
71786615|NCT01753856|143071697|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.004
71786616|NCT01753856|143071697|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in the CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786617|NCT01753856|143071697|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786618|NCT01753856|143071697|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786619|NCT01753856|143071697|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786620|NCT01753856|143071697|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786621|NCT01753856|143071697|SUPERIORITY_OR_OTHER|||||||0.931|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.931
71786622|NCT01753856|143071697|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.549
71786623|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786624|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786625|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786626|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786627|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71670087|NCT05516108|142857480|OTHER|||||||0.009|||||||Mixed Models Analysis|Stata mixed||time (pre, post, follow-up) x condition (mindfulness, coping)||||.009
71754130|NCT02977403|143011645|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity|beta coefficient|0.031|||||TWO_SIDED|95.0|-0.059|0.121||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.121|-0.059|
71754131|NCT02977403|143011645|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.002|||||TWO_SIDED|95.0|-0.157|0.152||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.152|-0.157|
71754132|NCT02977403|143011646|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.042|||||TWO_SIDED|95.0|-0.149|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.149|
71754133|NCT02977403|143011646|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.068|||||TWO_SIDED|95.0|-0.266|0.131||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.131|-0.266|
71786628|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786629|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786630|NCT01753856|143071698|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786631|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786632|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786633|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786634|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786635|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786636|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||dLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786637|NCT01753856|143071699|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||sLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||<0.001
71786638|NCT01753856|143071699|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||dLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.||||||0.028
71786639|NCT01753856|143071700|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786640|NCT01753856|143071700|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71677185|NCT01369108|142872994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||ANOVA|||null hypothesis no difference in surface integrity||||0.18
71677186|NCT01369108|142872994|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||null hypothesis no difference in secondary caries||||0.66
71786641|NCT01753856|143071700|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786642|NCT01753856|143071701|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786643|NCT01753856|143071701|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786644|NCT01753856|143071701|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786645|NCT01753856|143071702|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786646|NCT01753856|143071702|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786647|NCT01753856|143071702|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71677187|NCT01369108|142872995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||ANOVA|||null hypothesis no difference in sensitivity to cold||||0.522
71677188|NCT01369108|142872995|SUPERIORITY_OR_OTHER_LEGACY|||||||0.449|||||||Chi-squared|||null hypothesis no difference in biting pressure||||.449
71670088|NCT02717507|142857520|OTHER||Slope|0.163|STANDARD_ERROR_OF_MEAN|0.112||0.15|TWO_SIDED|95.0|-0.057|0.383|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVWT/Dz was statistically significant at a two-sided p\<0.05 and the expected LVWT/Dz was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVWT/Dz across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 0.6-0.8 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVWT/Dz at 24m.||0.383|-0.057|0.15
71670089|NCT02717507|142857521|OTHER||Slope|-3.764|STANDARD_ERROR_OF_MEAN|1.705||0.03|TWO_SIDED|95.0|-7.105|-0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.424|-7.105|0.03
71670090|NCT02717507|142857522|OTHER||Slope|-0.045|STANDARD_ERROR_OF_MEAN|0.023||0.05|TWO_SIDED|95.0|-0.09|0.001|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.001|-0.09|0.05
71670091|NCT02717507|142857523|OTHER||Slope|-2.194|STANDARD_ERROR_OF_MEAN|1.605||0.17|TWO_SIDED|95.0|-5.34|0.951|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVESV was statistically significant at a two-sided p\<0.05 and the expected LVESV was lower for carvedilol than placebo over time.|||0.951|-5.34|0.17
71670092|NCT02717507|142857524|OTHER||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.01|TWO_SIDED|95.0|-141.0|-0.024|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||-0.024|-0141|0.01
71670093|NCT02717507|142857525|OTHER||Slope|-2.397|STANDARD_ERROR_OF_MEAN|2.603||0.36|TWO_SIDED|95.0|-7.499|2.704|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEDV was statistically significant at a two-sided p\<0.05 and the expected LVEDV was lower for carvedilol than placebo over time.|||2.704|-7.499|0.36
71670094|NCT02717507|142857526|OTHER||Slope|0.433|STANDARD_ERROR_OF_MEAN|0.799||0.59|TWO_SIDED|95.0|-1.134|1.999|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||1.999|-1.134|0.59
71670095|NCT02717507|142857527|OTHER||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.302||0.84|TWO_SIDED|95.0|-0.652|0.532|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is positive|||0.532|-0.652|0.84
71670096|NCT02717507|142857528|OTHER||Slope|0.259|STANDARD_ERROR_OF_MEAN|0.373||0.49|TWO_SIDED|95.0|-0.472|0.991|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment was considered efficacious if the group by time interaction for LVEF was statistically significant at a two-sided p\<0.05 and the expected LVEF was higher for carvedilol than placebo over time.|The null hypothesis is that change in LVEF across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 1.2-1.6 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVEF at 24m.||0.991|-0.472|0.49
71670097|NCT02717507|142857529|OTHER||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.038||0.82|TWO_SIDED|95.0|-0.065|0.082|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.082|-0.065|0.82
71670098|NCT02717507|142857530|OTHER||Slope|2.121|STANDARD_ERROR_OF_MEAN|1.79||0.24|TWO_SIDED|95.0|-1.387|5.63|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||5.63|-1.387|0.24
71670099|NCT02717507|142857531|OTHER||Slope|5.113|STANDARD_ERROR_OF_MEAN|8.532||0.55|TWO_SIDED|95.0|-11.608|21.835|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative|||21.835|-11.608|0.55
71670100|NCT02717507|142857532|OTHER||Slope|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.51|TWO_SIDED|95.0|-0.004|0.002|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.002|-0.004|0.51
71670101|NCT02717507|142857533|OTHER||Slope|-0.022|STANDARD_ERROR_OF_MEAN|0.228||0.92|TWO_SIDED|95.0|-0.468|0.424|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||0.424|-0.468|0.92
71670102|NCT02717507|142857535|OTHER||Slope|0.024|STANDARD_ERROR_OF_MEAN|0.104||0.82|TWO_SIDED|95.0|-0.18|0.229|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|||0.229|-0.18|0.82
71670103|NCT02717507|142857536|OTHER||Slope|-0.096|STANDARD_ERROR_OF_MEAN|2.439||0.97|TWO_SIDED|95.0|-4.877|4.685|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.||||4.685|-4.877|0.97
71786648|NCT01753856|143071703|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 month.|Wilcoxon (Mann-Whitney)|||||||<0.001
71670104|NCT02717507|142857537|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|3.491||0.72|TWO_SIDED|95.0|-5.595|8.091|||Generalized Estimating Equation (GEE)|The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.|The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.|The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.||8.091|-5.595|0.72
71670105|NCT03500198|142857588|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
71670106|NCT03500198|142857590|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71670107|NCT03500198|142857591|SUPERIORITY||||||<|0.0001|||||||1-sided logistic regression|||||||<0.0001
71754134|NCT02977403|143011647|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.122|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.122|
71754135|NCT02977403|143011647|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.233|0.092||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.092|-0.233|
71754136|NCT02977403|143011648|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.042|||||TWO_SIDED|95.0|-0.041|0.126||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.126|-0.041|
71754137|NCT02977403|143011648|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.252|0.082||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.082|-0.252|
71786649|NCT01753856|143071703|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||3 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786650|NCT01753856|143071703|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||6 months.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786651|NCT01753856|143071704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786652|NCT01753856|143071704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786653|NCT01753856|143071704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786654|NCT01753856|143071704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786655|NCT01753856|143071704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786656|NCT01753856|143071704|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786657|NCT01753856|143071705|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||DL Only, in CC.|Wilcoxon (Mann-Whitney)|||||||0.002
71786658|NCT01753856|143071705|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786659|NCT01753856|143071705|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||DL Only, in EC.|Wilcoxon (Mann-Whitney)|||||||0.214
71786660|NCT01753856|143071705|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)|||||||0.031
71786661|NCT01753856|143071705|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL Only, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786662|NCT01753856|143071705|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786663|NCT01753856|143071706|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71786664|NCT01753856|143071707|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71670108|NCT01641640|142857620|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial exact test|||Superiority would be demonstrated if the SVR12 rate was higher than the 60% null SVR rate based on historical control data.||||< 0.001
71670109|NCT01234350|142857626|OTHER||IRR|0.829||||0.4007|TWO_SIDED|95.0|0.536|1.283||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|The IRs were estimated using a Poisson-mixture regression model.||1.283|0.536|0.4007
71670110|NCT01234350|142857627|OTHER||IRR|0.874||||0.671|TWO_SIDED|95.0|0.47|1.626||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.||1.626|0.470|0.6710
71836756|NCT05493787|143179703|SUPERIORITY|||||||0.052||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Waiting for You messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.052
71836757|NCT05493787|143179703|SUPERIORITY|||||||0.952||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Rare messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.952
71786665|NCT01753856|143071707|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786666|NCT01753856|143071707|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786667|NCT01753856|143071708|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786668|NCT01753856|143071708|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786669|NCT01753856|143071708|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786670|NCT01753856|143071709|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of DLs in the CC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
71786671|NCT01753856|143071709|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Average length of double labels in EC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.004
71786672|NCT01753856|143071709|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Average length of double labels in IC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||<0.001
71786673|NCT01753856|143071709|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|||||Average length of double labels in the PC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.||||||0.850
71786674|NCT01753856|143071710|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC.|Wilcoxon (Mann-Whitney)|||||||<0.001
71786675|NCT01753856|143071710|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED|||||EC.|Wilcoxon (Mann-Whitney)|||||||0.042
71786676|NCT01753856|143071710|SUPERIORITY_OR_OTHER|||||||0.678|TWO_SIDED|||||IC.|Wilcoxon (Mann-Whitney)|||||||0.678
71786677|NCT01753856|143071711|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CC|Wilcoxon (Mann-Whitney)|||||||<0.001
71786678|NCT01753856|143071711|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||EC|Wilcoxon (Mann-Whitney)|||||||<0.001
71786679|NCT01753856|143071711|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||IC|Wilcoxon (Mann-Whitney)|||||||<0.001
71786680|NCT00064844|143071715|SUPERIORITY_OR_OTHER_LEGACY||chi square|7.25|||<|0.01||95.0|||||Chi-squared|df = 1, N = 96||||||<0.01
71845463|NCT02350634|143205261|OTHER||Correlation coefficient|-0.189||||0.558|TWO_SIDED|||||A two-sided correlation test (rho ≠ 0) was performed with a significance level of alpha = 0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|||Null hypothesis is no correlation (correlation coefficient = 0)||||0.558
71786681|NCT04853225|143071801|OTHER||Adjusted rate of change|-59.46|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786682|NCT04853225|143071801|OTHER||Adjusted rate of change|-62.73|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786683|NCT04853225|143071801|OTHER||Adjusted rate of change|-48.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786684|NCT04853225|143071801|OTHER||Adjusted rate of change|-50.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786685|NCT04853225|143071801|OTHER||Adjusted rate of change|-22.67|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786686|NCT04853225|143071801|OTHER||Adjusted rate of change|-33.32|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786687|NCT04853225|143071801|OTHER||Adjusted rate of change|-20.4|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786688|NCT04853225|143071801|OTHER||Adjusted rate of change|-31.08|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786689|NCT04853225|143071801|OTHER||Adjusted rate of change|-64.74|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786690|NCT04853225|143071801|OTHER||Adjusted rate of change|-60.26|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786691|NCT04853225|143071801|OTHER||Adjusted rate of change|-27.85|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71836758|NCT05493787|143179703|SUPERIORITY|||||||0.386||||||Comparisons between Active Control and all other arms (Analyses 6-9) were analyzed in the same regression. The p-value reported is 2-tailed.|Regression, Linear|||Null hypothesis: Active Control messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: Protect Yourself - Frequent messages are more effective at promoting flu shot self-scheduling than Active Control messages. Analysis combines across November and December send dates.||||.386
71836759|NCT05493787|143179703|SUPERIORITY|||||||0.498||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Waiting for You messages. Analysis combines across November and December send dates.||||.498
71836760|NCT05493787|143179703|SUPERIORITY|||||||0.935||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Rare messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Rare messages. Analysis combines across November and December send dates.||||.935
71836761|NCT05493787|143179703|SUPERIORITY|||||||0.504||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Ease messages and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Ease and Protect Yourself - Frequent message messages. Analysis combines across November and December send dates.||||.504
71836762|NCT05493787|143179703|SUPERIORITY|||||||0.19||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Waiting for You messages. Analysis combines across November and December send dates.||||.190
71836763|NCT05493787|143179703|SUPERIORITY|||||||0.027||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Frequent messages and Waiting for You messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Frequent and Waiting for You messages. Analysis combines across November and December send dates.||||.027
71836764|NCT05493787|143179703|SUPERIORITY|||||||0.854||||||Pairwise comparisons between experimental arms (Analyses 10-15) were analyzed in the same regression. Reported p-values were 2-tailed and adjusted using Tukey's HSD test.|Regression, Linear|||Null hypothesis: Protect Yourself - Rare and Protect Yourself - Frequent messages are equally effective at promoting flu shot self-scheduling; Alternative hypothesis: There is a difference in effectiveness between Protect Yourself - Rare and Protect Yourself - Frequent messages. Analysis combines across November and December send dates.||||.854
71845464|NCT04241848|143205267|SUPERIORITY||||||=|0.007|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.007
71845465|NCT04241848|143205267|SUPERIORITY||||||=|0.24|||||||ANOVA|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.240
71670111|NCT01234350|142857627|OTHER||IRR|1.857||||0.4544|TWO_SIDED|95.0|0.367|9.403||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For bone fracture events. The IRs were estimated using Poisson-mixture regression model.||9.403|0.367|0.4544
71845466|NCT04241848|143205267|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||Within-group comparison of Five Times Sit to Stand Test (5xSTS), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.04
71845467|NCT04241848|143205270|SUPERIORITY|||||||0.129|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.129
71845468|NCT04241848|143205270|SUPERIORITY|||||||0.25|||||||ANOVA|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.250
71786692|NCT04853225|143071801|OTHER||Adjusted rate of change|-28.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786693|NCT04853225|143071802|OTHER||Adjusted rate of change|-87.47|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786694|NCT04853225|143071802|OTHER||Adjusted rate of change|-83.25|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786695|NCT04853225|143071802|OTHER||Adjusted rate of change|-77.54|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786696|NCT04853225|143071802|OTHER||Adjusted rate of change|-77.41|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786697|NCT04853225|143071802|OTHER||Adjusted rate of change|-60.1|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786698|NCT04853225|143071802|OTHER||Adjusted rate of change|-73.65|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786699|NCT04853225|143071802|OTHER||Adjusted rate of change|-45.44|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786700|NCT04853225|143071802|OTHER||Adjusted rate of change|-79.49|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786701|NCT04853225|143071802|OTHER||Adjusted rate of change|-74.39|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786702|NCT04853225|143071802|OTHER||Adjusted rate of change|-63.04|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786703|NCT04853225|143071802|OTHER||Adjusted rate of change|-25.59|||||||||||||Pre-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786704|NCT04853225|143071802|OTHER||Adjusted rate of change|-38.69|||||||||||||Post-bronchodilator. Adjusted rate of change was analyzed using Random Coefficient Model. The model was fitted with an unstructured variance-covariance matrix.|||||
71786705|NCT03918447|143071803|SUPERIORITY||Least Square Means Difference|0.97|STANDARD_ERROR_OF_MEAN|1.122|=|0.3886|TWO_SIDED|95.0|-1.25|3.19|||ANCOVA|||ANCOVA model with baseline eGFR as a covariate, and treatment group as fixed effects.||3.19|-1.25|=0.3886
71786706|NCT03918447|143071805|SUPERIORITY||Least Square Means Difference|7.94|STANDARD_ERROR_OF_MEAN|0.777|<|0.0001|TWO_SIDED|95.0|6.41|9.47|||MMRM|||Mixed model repeated measure (MMRM) model used baseline eGFR as a covariate, and the following fixed factors: treatment group, time (Week 1 to 100, excluding Week 52), and the interaction between treatment and time. Within-participant errors are modeled using an unstructured covariance matrix.||9.47|6.41|<0.0001
71786707|NCT01405456|143071862|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months||||0.71
71786708|NCT01405456|143071863|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months||||0.42
71786709|NCT01405456|143071864|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.51
71786710|NCT01405456|143071865|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months||||0.04
71786711|NCT01405456|143071866|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months||||0.44
71845469|NCT04241848|143205270|SUPERIORITY||||||=|0.073|||||||t-test, 2 sided|||Within-group comparison of Six Minute Walk Test (6MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.073
71786712|NCT01405456|143071867|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Mean serum measurements of Potassium||||0.07
71786713|NCT01405456|143071868|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change in Hemoglobin A1c from baseline to 6 months||||0.70
71786714|NCT01405456|143071869|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in C-Reactive Protein from baseline to 6 months||||0.10
71786715|NCT01405456|143071870|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months||||0.37
71786716|NCT01405456|143071871|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change in Adiponectin from baseline to 6 months||||0.78
71786717|NCT01405456|143071872|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in IL-6 from baseline to 6 months||||0.10
71786718|NCT01405456|143071873|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Change in MCP-1 from baseline to 6 months||||0.04
71786719|NCT05355805|143071875|SUPERIORITY||Risk Difference (RD)|8.27|STANDARD_ERROR_OF_MEAN|8.075||0.3055|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/Janus Kinase (JAK) inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.3055
71786720|NCT05355805|143071875|SUPERIORITY||Risk Difference (RD)|4.19|STANDARD_ERROR_OF_MEAN|8.427||0.6192|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error was estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR75."||||0.6192
71786721|NCT05355805|143071878|SUPERIORITY||Risk Difference (RD)|10.14|STANDARD_ERROR_OF_MEAN|7.229||0.1606|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.1606
71813120|NCT03720938|143128565|SUPERIORITY|||||||0.615648||||||The outcome of self-perception for sports competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for sports competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.615648
71670112|NCT01234350|142857628|OTHER||IRR|1.193||||0.2529|TWO_SIDED|95.0|0.882|1.613||Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.||1.613|0.882|0.2529
71670113|NCT01234350|142857628|OTHER||IRR|2.623||||0.0208|TWO_SIDED|95.0|1.158|5.944||Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit \>1 suggest increased risk of AESI; upper confidence limit \<1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For T2DM. The IRs were estimated using Poisson-mixture regression model.||5.944|1.158|0.0208
71670114|NCT01234350|142857635|OTHER||Odds Ratio (OR)|0.747||||0.0821|TWO_SIDED|95.0|0.537|1.038||A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.|Regression, Logistic|Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.||The analyses of all-cause mortality was based on logistic regressions.||1.038|0.537|0.0821
71670115|NCT01051960|142857640|OTHER|comparison of means|Mean Difference (Final Values)|-93.0||||0.0008|TWO_SIDED|||||significant at p\<0.05|t-test, 2 sided|||Whether change from baseline to 24-weeks is significantly different from zero||||.0008
71670116|NCT01051960|142857641|OTHER||Mean Difference (Final Values)|44.5||||7e-05|TWO_SIDED||||||t-test, 2 sided|||change from baseline to 24 weeks||||0.00007
71670117|NCT00776035|142857673|SUPERIORITY||||||<|0.005|||||||Student's t-test|||Average myocardial blood flow, men versus women||||<0.005
71754138|NCT02977403|143011649|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.06|0.102||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.102|-0.060|
71754139|NCT02977403|143011649|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.071|||||TWO_SIDED|95.0|-0.26|0.119||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.119|-0.260|
71754140|NCT02977403|143011650|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.107|||||TWO_SIDED|95.0|0.03|0.185||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.185|0.030|
71754141|NCT02977403|143011650|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.197|||||TWO_SIDED|95.0|-0.346|-0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.047|-0.346|
71754142|NCT02977403|143011651|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.092|||||TWO_SIDED|95.0|0.01|0.175||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.175|0.010|
71845470|NCT04241848|143205271|SUPERIORITY||||||=|0.091|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.091
71845471|NCT04241848|143205271|SUPERIORITY|||||||0.296|||||||ANOVA|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.296
71845472|NCT04241848|143205271|SUPERIORITY|||||||0.427|||||||t-test, 2 sided|||Within-group comparison of Ten Meter Walk Test (10MWT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.427
71670118|NCT00776035|142857674|SUPERIORITY||||||<|0.05|||||||Student's t-test|||Average myocardial fatty acid utilization, men versus women||||<0.05
71754143|NCT02977403|143011651|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.049|||||TWO_SIDED|95.0|-0.204|0.107||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.107|-0.204|
71754144|NCT02977403|143011652|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.046|||||TWO_SIDED|95.0|-0.032|0.123||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.123|-0.032|
71754145|NCT02977403|143011652|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.007|||||TWO_SIDED|95.0|-0.163|0.177||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.177|-0.163|
71754146|NCT02977403|143011653|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.041|||||TWO_SIDED|95.0|-0.03|0.112||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.112|-0.03|
71754147|NCT02977403|143011653|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.014|||||TWO_SIDED|95.0|-0.168|0.14||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.140|-0.168|
71754148|NCT02977403|143011654|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.037|||||TWO_SIDED|95.0|-0.125|0.052||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.052|-0.125|
71754149|NCT02977403|143011654|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.034|||||TWO_SIDED|95.0|-0.196|0.129||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.129|-0.196|
71813121|NCT03720938|143128565|SUPERIORITY|||||||0.608||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.608
71813122|NCT03720938|143128565|SUPERIORITY|||||||0.60938||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.||||0.60938
71813123|NCT03720938|143128566|SUPERIORITY|||||||0.094||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for physical condition competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.094
71813124|NCT03720938|143128566|SUPERIORITY|||||||0.085||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.||||0.085
71670119|NCT03335475|142857705|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
71754150|NCT02977403|143011655|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.001|||||TWO_SIDED|95.0|-0.091|0.093||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.093|-0.091|
71754151|NCT02977403|143011655|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.286|0.001||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.001|-0.286|
71670120|NCT03335475|142857706|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71786722|NCT05355805|143071878|SUPERIORITY||Risk Difference (RD)|4.79|STANDARD_ERROR_OF_MEAN|7.294||0.5116|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR90."||||0.5116
71670121|NCT03335475|142857707|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71786723|NCT05355805|143071879|SUPERIORITY||Risk Difference (RD)|13.67|STANDARD_ERROR_OF_MEAN|7.019||0.0514|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.0514
71813125|NCT03720938|143128566|SUPERIORITY|||||||0.08818||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.||||0.08818
71845473|NCT04241848|143205272|SUPERIORITY|||||||0.063|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.063
71670122|NCT02224157|142857759|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Upper limit of the 1-sided 95% confidence limit \<1.2 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid|Rate ratio|0.97|||||ONE_SIDED|95.0||1.16|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.16||
71813126|NCT03720938|143128567|SUPERIORITY|||||||0.058102||||||The outcome of self-perception for strength competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for strength competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.058102
71813127|NCT03720938|143128567|SUPERIORITY|||||||0.051||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.051
71813128|NCT03720938|143128567|SUPERIORITY|||||||0.0534||||||The outcome of self-perception for strength competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.||||0.0534
71813129|NCT03720938|143128568|SUPERIORITY|||||||0.638505||||||The outcome of self-perception for body attractiveness was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for body attractiveness at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.638505
71813130|NCT03720938|143128568|SUPERIORITY|||||||0.632||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.632
71754152|NCT02977403|143011656|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.065|||||TWO_SIDED|95.0|-0.001|0.132||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.132|-0.001|
71754153|NCT02977403|143011656|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.246|0.055||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.055|-0.246|
71670123|NCT02224157|142857760|SUPERIORITY||Hazard Ratio (HR)|0.955||||0.664|TWO_SIDED|95.0|0.777|1.174|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.174|0.777|0.664
71754154|NCT02977403|143011657|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.023|||||TWO_SIDED|95.0|-0.055|0.101||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.101|-0.055|
71754155|NCT02977403|143011657|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.02|||||TWO_SIDED|95.0|-0.178|0.137||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.137|-0.178|
71754156|NCT02977403|143011658|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.116|0.051||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.051|-0.116|
71754157|NCT02977403|143011658|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.06|||||TWO_SIDED|95.0|-0.104|0.223||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.223|-0.104|
71754158|NCT02977403|143011659|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.012|||||TWO_SIDED|95.0|-0.078|0.053||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.053|-0.078|
71786724|NCT05355805|143071879|SUPERIORITY||Risk Difference (RD)|6.56|STANDARD_ERROR_OF_MEAN|6.764||0.3322|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR100."||||0.3322
71845474|NCT04241848|143205272|SUPERIORITY|||||||0.447|||||||ANOVA|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.447
71754159|NCT02977403|143011659|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.064|||||TWO_SIDED|95.0|-0.248|0.12||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.120|-0.248|
71754160|NCT02977403|143011660|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.089|||||TWO_SIDED|95.0|0.004|0.174||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.174|0.004|
71754161|NCT02977403|143011660|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.021|||||TWO_SIDED|95.0|-0.159|0.201||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.201|-0.159|
71754162|NCT02977403|143011661|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.113|0.081||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.081|-0.113|
71754163|NCT02977403|143011661|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.072|||||TWO_SIDED|95.0|-0.206|0.062||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.062|-0.206|
71754164|NCT02977403|143011662|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.129|||||TWO_SIDED|95.0|0.049|0.209||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.209|0.049|
71754165|NCT02977403|143011662|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.181|||||TWO_SIDED|95.0|-0.33|-0.033||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.033|-0.330|
71754166|NCT02977403|143011663|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.126|||||TWO_SIDED|95.0|0.045|0.207||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.207|0.045|
71754167|NCT02977403|143011663|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.056|||||TWO_SIDED|95.0|-0.223|0.112||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.112|-0.223|
71758540|NCT02205736|143019222|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71786725|NCT05355805|143071880|SUPERIORITY||Risk Difference (RD)|8.63|STANDARD_ERROR_OF_MEAN|8.78||0.3258|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.3258
71786726|NCT05355805|143071880|SUPERIORITY||Risk Difference (RD)|7.28|STANDARD_ERROR_OF_MEAN|8.775||0.4068|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Non-response imputation was used for participants with missing HiSCR50."||||0.4068
71786727|NCT05355805|143071881|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|-7.4|STANDARD_ERROR_OF_MEAN|7.661||0.3329|TWO_SIDED|||||The estimated risk difference divided by the standard error will be used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.3329
71813131|NCT03720938|143128568|SUPERIORITY|||||||0.6328||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.||||0.63280
71813132|NCT03720938|143128569|SUPERIORITY|||||||0.007061||||||The outcome of self-perception of global physical self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global physical self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.007061
71836765|NCT05493787|143179703|SUPERIORITY|||||||0.637||||||The reported p-value (2-tailed) is for the interaction term between message send date (November, December) and message (any message arm no message)|Regression, Linear|||"Null Hypothesis: Messages sent in November and December are equally effective at promoting flu-shot self-scheduling. Alternative hypothesis: Messages sent in November and December are differentially effective.~To test the alternative hypothesis, all message arms (Active control, Ease, Waiting for you, Protect yourself - rare, Protect yourself - frequent) were combined and compared with Passive control."||||.637
71836766|NCT02437318|143179714|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.00065|TWO_SIDED|95.0|0.5|0.85||(one-sided)|Log Rank|||||0.85|0.50|0.00065
71836767|NCT05493423|143179728|NON_INFERIORITY|The null hypothesis is that the difference between the rates of completed hemodialysis sessions for the test and control groups is less than or equal to the non-inferiority margin (indicating inferior success rate). Rejection of the null hypothesis indicates the data supports the alternative hypothesis that the difference between the rates of successfully completed HD sessions for the test and control groups is at least the non-inferiority margin (indicating non-inferior success rate).||||||0.008|||||||Farrington-Manning|non-inferiority margin = 0.08||||||.008
71836768|NCT05493423|143179728|EQUIVALENCE|non-inferiority margin = 0.08||||||0.002|||||||Equivalence Test with paired data|||||||.002
71836769|NCT05493423|143179729|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
71836770|NCT05493423|143179730|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
71836771|NCT05493423|143179731|SUPERIORITY|||||||0.132|||||||t-test, 2 sided|||||||0.132
71836772|NCT05493423|143179732|SUPERIORITY|||||||0.84||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.84
71891913|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.04|-0.02|
71891914|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.01|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|-0.01|
71836773|NCT05493423|143179733|SUPERIORITY|||||||0.197||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.197
71670124|NCT02224157|142857761|SUPERIORITY||Least Square Mean Difference|-32.6||||0.003|TWO_SIDED|95.0|-53.7|-11.4|||Mixed Models Analysis|Rand treatment,pre-study treatment,region,visit,rand treatment by visit; fixed effects. Patient; random effect, baseline FEV1; covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. Estimate corresponds to average treatment effect across all treatment visits.|||-11.4|-53.7|0.003
71670125|NCT02224157|142857763|SUPERIORITY||Least Square Mean Difference|0.03|||||TWO_SIDED|95.0|0.0|0.07||No p-value was calculated for this efficacy variable|ANCOVA|Model with randomised treatment, pre-study treatment and region as factors, and no. of 'as needed' inhalations at baseline as continuous covariate|A mean difference less than zero indicates a larger mean reduction in number of 'as needed' inhalations in the Symbicort 'as needed' group.|||0.07|0.00|
71670126|NCT02224157|142857764|SUPERIORITY||Least Square Mean Difference|-6.85|||<|0.001|TWO_SIDED|95.0|-8.37|-5.34|||ANCOVA|adjusted for randomised treatment, pre-study treatment and region as factors and the percent 'as needed' free days during run-in as a cont covariate.|An estimate of difference \>0 means that there was a larger increase in the % of 'as needed' free days in the Symbicort 'as-needed' arm.|||-5.34|-8.37|< 0.001
71670127|NCT02224157|142857765|SUPERIORITY||Least Square Mean Difference|-37.48|||<|0.001|TWO_SIDED|95.0|-39.18|-35.77|||ANOVA|model adjusted for: randomised treatment, pre-study treatment and region.|An estimate of difference \>0 means that there was a higher % of controller use days in the Symbicort 'as-needed' group.|||-35.77|-39.18|<0.001
71670128|NCT02224157|142857766|SUPERIORITY||Least Square Mean Difference|0.109|||<|0.001|TWO_SIDED|95.0|0.068|0.15|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random, and baseline ACQ-5 as covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.150|0.068|<0.001
71670129|NCT02224157|142857767|SUPERIORITY||Least Square Mean Difference|-0.096|||<|0.001|TWO_SIDED|95.0|-0.137|-0.054|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random and baseline AQLQ as covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.054|-0.137|<0.001
71670130|NCT02224157|142857768|SUPERIORITY||Rate ratio|0.97||||0.754|TWO_SIDED|95.0|0.78|1.2|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.|||1.20|0.78|0.754
71670131|NCT05906628|142857796|SUPERIORITY||Odds Ratio (OR)|9.82|||<|0.0001|TWO_SIDED|95.0|4.48|21.49|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||||21.49|4.48|<0.0001
71670132|NCT05906628|142857796|SUPERIORITY||Response rate difference|42.5|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|30.7|54.36||||||||54.36|30.70|
71670133|NCT05906628|142857797|SUPERIORITY||Odds Ratio (OR)|4.23|||<|0.0001|TWO_SIDED|95.0|2.14|8.38|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 4||8.38|2.14|<0.0001
71670134|NCT05906628|142857797|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.52|||TWO_SIDED|95.0|16.69|42.24||||||Week 4||42.24|16.69|
71786728|NCT05355805|143071881|SUPERIORITY|Predictors in the regression model for missing values at Week 16 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, BMI and Prior Biologic/JAK inhibitor use for HS plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.|Risk Difference (RD)|4.06|STANDARD_ERROR_OF_MEAN|7.574||0.5882|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||"The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.~Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern."||||0.5882
71670135|NCT05906628|142857797|SUPERIORITY||Odds Ratio (OR)|3.9|||<|0.0001|TWO_SIDED|95.0|2.02|7.51|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||7.51|2.02|<0.0001
71836774|NCT05493423|143179734|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
71836775|NCT05493423|143179735|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
71836776|NCT05493423|143179736|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to as 0 by the statistical software.|t-test, 2 sided|||||||0
71670136|NCT05906628|142857797|SUPERIORITY||Response rate difference|29.5|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|95.0|16.34|42.57||||||Week 16||42.57|16.34|
71670137|NCT05906628|142857798|SUPERIORITY||Odds Ratio (OR)|2.06||||0.1789|TWO_SIDED|95.0|0.718|5.923|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Day 3||5.923|0.718|0.1789
71670138|NCT05906628|142857798|SUPERIORITY||Odds Ratio (OR)|3.79||||0.0024|TWO_SIDED|95.0|1.603|8.951|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 1 (Day 7)||8.951|1.603|0.0024
71670139|NCT05906628|142857799|SUPERIORITY||Odds Ratio (OR)|9.91|||<|0.0001|TWO_SIDED|95.0|4.44|22.13|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by stratification factors IGA-CHE score (3 or 4) and region (North America or outside of North America).||Week 16||22.13|4.44|<0.0001
71670140|NCT05906628|142857799|SUPERIORITY||Response rate difference|45.6|STANDARD_ERROR_OF_MEAN|6.49|||TWO_SIDED|95.0|32.83|58.27||||||Week 16||58.27|32.83|
71836777|NCT05493423|143179737|SUPERIORITY|||||||0.57||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.57
71836778|NCT05493423|143179738|SUPERIORITY|||||||0||||||The p-value was calculated, but was low enough to be rounded down to 0 by the statistical software.|t-test, 2 sided|||||||0
71836779|NCT05493423|143179739|SUPERIORITY|||||||0.211|||||||t-test, 2 sided|||||||0.211
71670141|NCT05906628|142857801|SUPERIORITY||Cox regression model|1.719||||0.0025|TWO_SIDED|95.0|1.211|2.44|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||2.440|1.211|0.0025
71786729|NCT05355805|143071882|SUPERIORITY||Risk Difference (RD)|7.31|STANDARD_ERROR_OF_MEAN|11.995||0.5422|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.5422
71786730|NCT05355805|143071882|SUPERIORITY||Risk Difference (RD)|-5.23|STANDARD_ERROR_OF_MEAN|11.77||0.6569|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.6569
71786731|NCT05355805|143071883|SUPERIORITY||Risk Difference (RD)|7.48|STANDARD_ERROR_OF_MEAN|8.951||0.4031|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg QW arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.4031
71786732|NCT05355805|143071883|SUPERIORITY||Risk Difference (RD)|21.27|STANDARD_ERROR_OF_MEAN|9.959||0.0327|TWO_SIDED|||||The estimated risk difference divided by the standard error was used as the test statistic and a p-value calculated assuming that the test statistic follows a standard normal distribution under the null hypothesis.|Cochran-Mantel-Haenszel|||The common risk difference between placebo QW/Q2W and the izokibep 160 mg Q2W arm among the four strata, prior biologic/JAK inhibitor use for HS (Yes/No) and Hurley Stage (II or III), used for randomization and associated standard error will be estimated by combining the observed risk differences using Cochran-Mantel-Haenszel weighting.||||0.0327
71786733|NCT01804075|143071914|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.6
71786734|NCT02310568|143071920|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.01||0.784|TWO_SIDED|90.0|-2.8|3.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.9|-2.8|0.784
71786735|NCT02310568|143071920|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.94||0.184|TWO_SIDED|90.0|-0.6|5.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||5.8|-0.6|0.184
71786736|NCT02310568|143071920|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.22||0.36|TWO_SIDED|90.0|-5.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||1.6|-5.7|0.360
71786737|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.36||0.708|TWO_SIDED|90.0|-3.2|5.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.0|-3.2|0.708
71786738|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.36||0.646|TWO_SIDED|90.0|-5.2|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.0|-5.2|0.646
71836780|NCT05493423|143179740|SUPERIORITY|||||||0.804||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.804
71836781|NCT05493423|143179741|SUPERIORITY|||||||0.307||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.307
71836782|NCT05493423|143179742|SUPERIORITY|||||||0.315||||||P \< 0.05 is considered significant|t-test, 2 sided|||||||0.315
71836783|NCT01426425|143179769|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.926|||<|0.0001|TWO_SIDED|95.0|0.895|0.948|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.83~Ha: PE \> 0.83~Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal."||0.948|0.895|<0.0001
71845475|NCT04241848|143205272|SUPERIORITY|||||||0.096|||||||t-test, 2 sided|||Within-group comparison of Timed Up and Go (TUG) Test, from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.096
71670142|NCT05906628|142857804|SUPERIORITY||Cox regression model|1.279||||0.1319|TWO_SIDED|95.0|0.931|1.759|||Log Rank|stratified by randomization stratification factors|Cox regression model stratified by stratification factors (Baseline IGA-CHE 3/4, Region : North America or outside of North America) was conducted to compare the difference in hazard rate between treatment and vehicle.|||1.759|0.931|0.1319
71754168|NCT02977403|143011664|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.115|||||TWO_SIDED|95.0|0.027|0.203||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.203|0.027|
71754169|NCT02977403|143011664|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.058|||||TWO_SIDED|95.0|-0.203|0.087||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.087|-0.203|
71754170|NCT02977403|143011665|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.037|||||TWO_SIDED|95.0|-0.053|0.127||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.127|-0.053|
71754171|NCT02977403|143011665|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.24|0.069||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.069|-0.240|
71754172|NCT02977403|143011666|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.021|||||TWO_SIDED|95.0|-0.092|0.05||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.050|-0.092|
71754173|NCT02977403|143011666|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.249|0.056||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.056|-0.249|
71754174|NCT02977403|143011667|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.095|0.069||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.069|-0.095|
71754175|NCT02977403|143011667|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.078|||||TWO_SIDED|95.0|-0.227|0.071||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.071|-0.227|
71786739|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.09||0.352|TWO_SIDED|90.0|-1.6|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||5.6|-1.6|0.352
71786740|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.99||0.495|TWO_SIDED|90.0|-3.1|7.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.3|-3.1|0.495
71845476|NCT04241848|143205273|SUPERIORITY|||||||0.035|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.035
71836784|NCT01426425|143179770|SUPERIORITY_OR_OTHER_LEGACY||Safety failure probability at 6 months|0.01|||<|0.0001|TWO_SIDED|95.0|0.004|0.027|||Kaplan-Meier log-log 95% CI||The chronic safety failure probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: Ps ≥ 0.07~Ha: Ps \< 0.07~Where Ps is the probability of a subject experiencing at least one safety event through 6 months with a 0.07 pre-specified performance goal."||0.027|0.004|<0.0001
71836785|NCT01426425|143179771|SUPERIORITY_OR_OTHER_LEGACY||Chronic effectiveness prob at 6 months|0.973|||<|0.0001|TWO_SIDED|95.0|0.95|0.985|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.80~Ha: PE \> 0.80~Where PE is the probability of a subject achieving chronic effectiveness success at 6-month follow-up, and 0.80 is the pre-specified performance goal. As pre-defined in the study protocol, this hypothesis is tested if the primary effectiveness objective null hypothesis (Ho) is rejected."||0.985|0.950|<0.0001
71836786|NCT04321031|143179814|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.02|0.2|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the statistical analysis plan (SAP).||0.20|-0.02|
71845477|NCT04241848|143205273|SUPERIORITY||||||=|0.677|||||||ANOVA|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.677
71786741|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.99||0.422|TWO_SIDED|90.0|-2.7|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-2.7|0.422
71786742|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.65||0.889|TWO_SIDED|90.0|-5.0|4.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.2|-5.0|0.889
71786743|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|2.71||0.324||90.0|-2.0|7.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.4|-2.0|0.324
71786744|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.69||0.939|TWO_SIDED|90.0|-4.5|4.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||4.9|-4.5|0.939
71786745|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.42||0.308|TWO_SIDED|90.0|-1.7|6.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||6.7|-1.7|0.308
71845478|NCT04241848|143205273|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||Within-group comparison of Step Length of Paretic (Pa) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.022
71845479|NCT04241848|143205274|SUPERIORITY||||||=|0.098|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.098
71845480|NCT04241848|143205274|SUPERIORITY|||||||0.666|||||||ANOVA|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||0.666
71845481|NCT04241848|143205274|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||Within-group comparison of Step lengths of the non-paretic (NP) Lower Extremities (LE), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||=0.007
71845482|NCT04241848|143205275|SUPERIORITY||||||=|0.001|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.001
71845483|NCT04241848|143205275|SUPERIORITY||||||=|0.009|||||||ANOVA|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while not wearing the Powered Exoskeleton.||||=0.009
71845484|NCT04241848|143205275|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Within-group comparison of the Stair Climb Power Test (SCPT), from Baseline to after completing 36 training sessions. Assessed while wearing the Powered Exoskeleton.||||0.018
71845485|NCT02063659|143205281|SUPERIORITY||Hodges-Lehman estimator of difference|-53.955|||<|0.001|TWO_SIDED|95.0|-84.955|-25.119|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-25.119|-84.955|< 0.001
71845486|NCT02063659|143205281|SUPERIORITY||Hodges-Lehman estimator of difference|-89.662|||<|0.001|TWO_SIDED|95.0|-113.104|-63.863|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.|-63.863|-113.104|< 0.001
71845487|NCT01532999|143205297|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks. Data structure involved repeated measures over time nested within participant, who in turn, was nested within a therapy group. Models included a random intercept, a random slope, and fixed effects for treatment condition, time, and the stratification variable (site). Rejection of the null hypothesis of no treatment effect if this interaction was statistically significant (two-tailed α = .05).||||0.5
71754176|NCT02977403|143011668|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.005|||||TWO_SIDED|95.0|-0.103|0.092||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.092|-0.103|
71786746|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|3.92||0.846|TWO_SIDED|90.0|-6.0|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||7.6|-6.0|0.846
71786747|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|3.89||0.449|TWO_SIDED|90.0|-9.8|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||3.7|-9.8|0.449
71786748|NCT02310568|143071922|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|3.51||0.295|TWO_SIDED|90.0|-2.3|9.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).||9.9|-2.3|0.295
71754177|NCT02977403|143011668|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.032|||||TWO_SIDED|95.0|-0.173|0.11||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.110|-0.173|
71754178|NCT02977403|143011669|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.02|||||TWO_SIDED|95.0|-0.069|0.109||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.109|-0.069|
71754179|NCT02977403|143011669|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.088|||||TWO_SIDED|95.0|-0.252|0.077||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.077|-0.252|
71754180|NCT02977403|143011670|OTHER|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.099|0.08||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.080|-0.099|
71754181|NCT02977403|143011670|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.155|||||TWO_SIDED|95.0|-0.294|-0.017||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.017|-0.294|
71758541|NCT02205736|143019222|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
71836787|NCT04321031|143179814|SUPERIORITY||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-0.03|0.24|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.24|-0.03|
71670143|NCT05317312|142857827|SUPERIORITY||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|12.08||0.123|TWO_SIDED|95.0|-5.2|42.7|||Emax||The estimated difference between 1.25mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||42.7|-5.2|0.123
71754182|NCT02977403|143011671|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.013|||||TWO_SIDED|95.0|-0.069|0.095||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.095|-0.069|
71786749|NCT02310568|143071924|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.72||0.514|TWO_SIDED|90.0|-4.0|1.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-4.0|0.514
71786750|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.65||0.302|TWO_SIDED|90.0|-4.5|1.0|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.0|-4.5|0.302
71786751|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.736|TWO_SIDED|90.0|-2.6|3.8|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.8|-2.6|0.736
71786752|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.85||0.775|TWO_SIDED|90.0|-5.6|7.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||7.8|-5.6|0.775
71786753|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.0||0.553|TWO_SIDED|90.0|-9.4|4.5|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.5|-9.4|0.553
71836788|NCT04321031|143179814|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.03|0.26|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.26|-0.03|
71836789|NCT04321031|143179814|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.04|0.28|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.28|-0.04|
71836790|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.32||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|-0.04|
71836791|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.11|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.11|
71836792|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.12|||||TWO_SIDED|90.0|-0.07|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.07|
71836793|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.07|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|0.07|
71836794|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|90.0|-0.12|0.27||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.27|-0.12|
71836795|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.04|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.04|
71836796|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|50.0|0.08|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.08|
71836797|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.31||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.31|-0.03|
71786754|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|3.3||0.299|TWO_SIDED|90.0|-2.2|9.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||9.3|-2.2|0.299
71786755|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.65||0.994|TWO_SIDED|90.0|-1.1|1.1|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.1|0.994
71786756|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.87|TWO_SIDED|90.0|-0.9|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-0.9|0.870
71786757|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.74||0.885|TWO_SIDED|90.0|-1.3|1.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-1.3|0.885
71786758|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.834|TWO_SIDED|90.0|-3.5|2.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.7|-3.5|0.834
71836798|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|50.0|0.09|0.26||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|0.09|
71836799|NCT04321031|143179815|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|-0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|-0.03|
71836800|NCT04321031|143179816|SUPERIORITY||Least Square (LS) Mean|-25.98|||||TWO_SIDED|90.0|-58.42|-2.57||||||||-2.57|-58.42|
71836801|NCT04321031|143179816|SUPERIORITY||LS Mean|-35.41|||||TWO_SIDED|90.0|-69.41|-5.42||||||||-5.42|-69.41|
71836802|NCT04321031|143179816|SUPERIORITY||LS Mean|-40.54|||||TWO_SIDED|90.0|-75.55|-7.32||||||||-7.32|-75.55|
71670144|NCT05317312|142857827|SUPERIORITY||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|10.25|<|0.001|TWO_SIDED|95.0|14.4|55.0|||Emax||||The estimated difference between 5mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|55.0|14.4|<0.001
71836803|NCT04321031|143179816|SUPERIORITY||LS Mean|-44.74|||||TWO_SIDED|90.0|-81.72|-8.42||||||||-8.42|-81.72|
71845488|NCT01532999|143205298|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.57
71845489|NCT01532999|143205300|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
71845490|NCT01532999|143205301|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.8
71845491|NCT01532999|143205302|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.4
71845492|NCT01532999|143205303|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.||||0.35
71845493|NCT01532999|143205304|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.3
71845494|NCT01532999|143205305|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Regression, Logistic|||Mixed effects logistic regression analysis.||||0.7
71845495|NCT01274338|143205412|SUPERIORITY|||||||0.065||||||This design provides at least 80% power at a one sided type I error rate of 0.003.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.065
71845496|NCT01274338|143205413|SUPERIORITY|This design will provide 80% power to detect the difference between the two arms at a one-sided type I error rate of 0.022.||||||0.044|||||||Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.044
71670145|NCT05317312|142857827|SUPERIORITY||Mean Difference (Final Values)|42.8|STANDARD_ERROR_OF_MEAN|9.53|<|0.001|TWO_SIDED|95.0|23.9|61.7|||Emax||The estimated difference between 15mg bid and placebo is based on the Emax model. The values that appear in the Outcome Measure Data Table are observed values.|||61.7|23.9|<0.001
71786759|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.8||0.281|TWO_SIDED|90.0|-5.1|1.1|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.1|-5.1|0.281
71786760|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.43||0.272|TWO_SIDED|90.0|-0.9|4.1|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||4.1|-0.9|0.272
71786761|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.249|TWO_SIDED|90.0|-2.1|0.4|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.4|-2.1|0.249
71786762|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|90.0|-2.9|-0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.6|-2.9|0.016
71786763|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.285|TWO_SIDED|0.285|-0.5|2.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.3|-0.5|0.285
71786764|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.38||0.635|TWO_SIDED|90.0|-3.1|1.8|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.8|-3.1|0.635
71670146|NCT05317312|142857828|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.0|0.2|||||The estimated difference between 1.5mg bid and placebo is based on Mixed Model Repeated Measures.The values in the Outcome Measure Data are observed mean values.|||0.2|-2.0|
71786765|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.43||0.217|TWO_SIDED|90.0|-4.4|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-4.4|0.217
71786766|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.399|TWO_SIDED|90.0|-1.2|3.6|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.6|-1.2|0.399
71786767|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.429|TWO_SIDED|90.0|-1.5|0.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.5|-1.5|0.429
71786768|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.26|TWO_SIDED|90.0|-1.7|0.3|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.3|-1.7|0.260
71836804|NCT04321031|143179817|SUPERIORITY||LS Mean|-41.82|||||TWO_SIDED|90.0|-62.57|-9.57||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-9.57|-62.57|
71754183|NCT02977403|143011671|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.085|||||TWO_SIDED|95.0|-0.216|0.047||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.047|-0.216|
71754184|NCT02977403|143011672|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.041|||||TWO_SIDED|95.0|-0.123|0.041||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.041|-0.123|
71786769|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.799|TWO_SIDED|90.0|-1.0|1.3|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.3|-1.0|0.799
71786770|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.22||0.738|TWO_SIDED|90.0|-1.7|2.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.5|-1.7|0.738
71786771|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|-0.5||0.691|TWO_SIDED|90.0|-2.7|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-2.7|0.691
71670147|NCT05317312|142857828|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.8|0.4|||||The estimated difference between 5mg bid and placebo is based on Mixed Model Repeated Measures. The values in the Outcome Measure Data are observed mean values|||0.4|-1.8|
71836805|NCT04321031|143179817|SUPERIORITY||LS Mean|-43.33|||||TWO_SIDED|90.0|-62.37|-14.64||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-14.64|-62.37|
71836806|NCT04321031|143179817|SUPERIORITY||LS Mean|-59.35|||||TWO_SIDED|90.0|-73.95|-36.55||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-36.55|-73.95|
71836807|NCT04321031|143179817|SUPERIORITY||LS Mean|-68.21|||||TWO_SIDED|90.0|-79.72|-50.15||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.15|-79.72|
71836808|NCT04321031|143179817|SUPERIORITY||LS Mean|-50.46|||||TWO_SIDED|90.0|-69.53|-19.44||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-19.44|-69.53|
71836809|NCT04321031|143179817|SUPERIORITY||LS Mean|-69.27|||||TWO_SIDED|90.0|-81.08|-50.07||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-50.07|-81.08|
71836810|NCT04321031|143179817|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|50.0|-34.02|-7.32||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-7.32|-34.02|
71836811|NCT04321031|143179817|SUPERIORITY||LS Mean|-21.8|||||TWO_SIDED|90.0|-48.51|18.76||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||18.76|-48.51|
71836812|NCT04321031|143179817|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|50.0|-49.4|-23.95||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||-23.95|-49.40|
71836813|NCT04321031|143179817|SUPERIORITY||LS Mean|-37.97|||||TWO_SIDED|90.0|-62.41|2.37||||||Log-transformed relative changes from baseline are modelled using an ANCOVA model with treatment and baseline fibrosis stage (F2/F3) as factors, and log-transformed baseline liver fat as a covariate.||2.37|-62.41|
71836814|NCT04321031|143179818|SUPERIORITY||Risk Difference (RD)|0.21|||||TWO_SIDED|90.0|0.09|0.32|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.32|0.09|
71670148|NCT05317312|142857828|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-1.9|0.3|||||The estimated difference between 15mg bid and placebo is based on Mixed Model Repeated Measures.. The values in the Outcome Measure Data are observed mean values|||0.3|-1.9|
71670149|NCT05317312|142857829|SUPERIORITY|||||||0.036|||||||Log Rank|||||||0.036
71836815|NCT04321031|143179818|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.15|0.37|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.37|0.15|
71836816|NCT04321031|143179818|SUPERIORITY||Risk Difference (RD)|0.29|||||TWO_SIDED|90.0|0.18|0.39|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.39|0.18|
71836817|NCT04321031|143179818|SUPERIORITY||Risk Difference (RD)|0.31|||||TWO_SIDED|90.0|0.19|0.42|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.42|0.19|
71836818|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.04|0.51||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.51|0.04|
71836819|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.37|||||TWO_SIDED|90.0|0.13|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.13|
71836820|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.04|0.49||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.49|0.04|
71670150|NCT05317312|142857829|SUPERIORITY|||||||0.006|||||||Log Rank|||||||0.006
71670151|NCT05317312|142857829|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71670152|NCT05317312|142857830|SUPERIORITY|||||||0.411|||||||Log Rank|||||||0.411
71670153|NCT05317312|142857830|SUPERIORITY|||||||0.383|||||||Log Rank|||||||0.383
71670154|NCT05317312|142857830|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71670155|NCT05317312|142857831|SUPERIORITY||Risk Difference (RD)|27.4||||0.042|TWO_SIDED|95.0|2.0|52.7|||Chi-squared|||||52.7|2.0|0.042
71670156|NCT05317312|142857831|SUPERIORITY||Risk Difference (RD)|34.5||||0.01|TWO_SIDED|95.0|9.7|59.3|||Chi-squared|||||59.3|9.7|0.01
71836821|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.54|||||TWO_SIDED|90.0|0.26|0.75||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.75|0.26|
71836822|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.34|||||TWO_SIDED|90.0|0.1|0.61||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.61|0.10|
71836823|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.2|0.72||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.72|0.20|
71836824|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|50.0|0.24|0.39||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.39|0.24|
71670157|NCT05317312|142857831|SUPERIORITY||Risk Difference (RD)|51.9|||<|0.001|TWO_SIDED|95.0|29.6|74.1|||Chi-squared|||||74.1|29.6|<0.001
71670158|NCT05317312|142857832|SUPERIORITY||Risk Difference (RD)|-31.2||||0.019|TWO_SIDED|95.0|-55.9|-6.5|||Chi-squared|||||-6.5|-55.9|0.019
71670159|NCT05317312|142857832|SUPERIORITY||Risk Difference (RD)|-16.9||||0.187|TWO_SIDED|95.0|-41.6|7.8|||Chi-squared|||||7.8|-41.6|0.187
71670160|NCT05317312|142857832|SUPERIORITY||Risk Difference (RD)|-44.4||||0.001|TWO_SIDED|95.0|-68.3|20.6|||Chi-squared|||||20.6|-68.3|0.001
71670161|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2536||||||Cycle 1. No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.2536
71670162|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.23||0.5757||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.5757
71670163|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6065||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6065
71670164|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.31||0.4301||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.4301
71670165|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.49||0.3125||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.3125
71670166|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.8169||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.8169
71670167|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.4||0.9359|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.9359
71754185|NCT02977403|143011672|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.213|0.021||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.021|-0.213|
71836825|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.32|||||TWO_SIDED|90.0|0.12|0.48||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.48|0.12|
71836826|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|50.0|0.06|0.23||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|0.06|
71836827|NCT04321031|143179819|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.06|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.06|
71670168|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6233|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.6233
71670169|NCT00380874|142857839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.5||0.1569||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.||||0.1569
71754186|NCT02977403|143011673|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.038|||||TWO_SIDED|95.0|-0.142|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.142|
71754187|NCT02977403|143011673|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.096|||||TWO_SIDED|95.0|-0.29|0.097||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.097|-0.290|
71754188|NCT02977403|143011674|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.023|||||TWO_SIDED|95.0|-0.105|0.059||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.059|-0.105|
71891915|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|0.0|0.06||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.06|0.00|
71754189|NCT02977403|143011674|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.124|||||TWO_SIDED|95.0|-0.277|0.029||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.029|-0.277|
71754190|NCT02977403|143011675|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.057|||||TWO_SIDED|95.0|-0.14|0.027||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.027|-0.140|
71754191|NCT02977403|143011675|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.161|||||TWO_SIDED|95.0|-0.302|-0.02||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.020|-0.302|
71670170|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7207||95.0|-0.25|0.17||Model terms include treatment, study center, and baseline score.|ANCOVA|Cycle 1. No multiple comparisons adjustment was made.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1.||0.17|-0.25|0.7207
71786772|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.11||0.417|TWO_SIDED|90.0|-1.0|2.9|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.9|-1.0|0.417
71786773|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.11||0.998|TWO_SIDED|90.0|-3.7|3.7|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||3.7|-3.7|0.998
71786774|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.16||0.353|TWO_SIDED|90.0|-5.8|1.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-5.8|0.353
71670171|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.3111||95.0|-0.36|1.1||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2.||1.10|-0.36|0.3111
71836828|NCT04321031|143179820|SUPERIORITY||Risk Difference (RD)|-0.05|||||TWO_SIDED|90.0|-0.16|0.02|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.02|-0.16|
71836829|NCT04321031|143179820|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.2|0.03|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.03|-0.20|
71670172|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.48||0.5925||95.0|-0.7|1.22||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3.||1.22|-0.70|0.5925
71670173|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5812||95.0|-0.8|1.41||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4.||1.41|-0.80|0.5812
71836830|NCT04321031|143179820|SUPERIORITY||Risk Difference (RD)|-0.09|||||TWO_SIDED|90.0|-0.23|0.04|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.04|-0.23|
71836831|NCT04321031|143179820|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.05|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.05|-0.26|
71836832|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|-0.07|||||TWO_SIDED|90.0|-0.21|0.13||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.13|-0.21|
71670174|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.7||0.2925||95.0|-0.67|2.16||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5.||2.16|-0.67|0.2925
71836833|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|-0.14|||||TWO_SIDED|90.0|-0.25|0.02||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.02|-0.25|
71836834|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|-0.02|||||TWO_SIDED|90.0|-0.17|0.17||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.17|-0.17|
71836835|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|90.0|-0.15|0.22||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.22|-0.15|
71836836|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|-0.22|||||TWO_SIDED|90.0|-0.3|-0.05||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||-0.05|-0.30|
71836837|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.13|0.26||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.26|-0.13|
71836838|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|50.0|-0.03|0.12||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.12|-0.03|
71836839|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.12|0.23||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.23|-0.12|
71836840|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|50.0|0.17|0.38||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|0.17|
71836841|NCT04321031|143179821|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.06|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.06|
71836842|NCT04321031|143179822|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.01|0.08|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.08|-0.01|
71836843|NCT04321031|143179822|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.09|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.09|-0.02|
71836844|NCT04321031|143179822|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.11|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.11|-0.02|
71891916|NCT03193866|143305380|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.03||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.03|-0.06|
71670175|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.54||0.9276||95.0|-1.15|1.05||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.||1.05|-1.15|0.9276
71836845|NCT04321031|143179822|SUPERIORITY||Risk Difference (RD)|0.05|||||TWO_SIDED|90.0|-0.02|0.12|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.12|-0.02|
71670176|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9952||95.0|-1.06|1.07|||ANCOVA|Model terms include treatment, study center, and baseline score.||Cycle 7.||1.07|-1.06|0.9952
71786775|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.296|TWO_SIDED|90.0|-1.3|5.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||5.4|-1.3|0.296
71786776|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95||0.841|TWO_SIDED|90.0|-1.8|1.5|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.5|-1.8|0.841
71786777|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.95||0.332|TWO_SIDED|90.0|-2.6|0.7|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.7|-2.6|0.332
71786778|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.81||0.359|TWO_SIDED|90.0|-0.6|2.2|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.2|-0.6|0.359
71786779|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78||0.347|TWO_SIDED|90.0|-2.1|0.6|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-2.1|0.347
71786780|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.8||0.041|TWO_SIDED|90.0|-3.2|-0.4|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||-0.4|-3.2|0.041
71786781|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.79||0.212|TWO_SIDED|90.0|-0.4|2.4|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||2.4|-0.4|0.212
71836846|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
71670177|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.6265||95.0|-0.85|1.38|||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8.||1.38|-0.85|0.6265
71836847|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.03|||||TWO_SIDED|90.0|-0.02|0.29||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.29|-0.02|
71836848|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.09|||||TWO_SIDED|90.0|-0.01|0.43||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.43|-0.01|
71836849|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.57||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.57|0.01|
71836850|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.04|||||TWO_SIDED|90.0|-0.02|0.33||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.33|-0.02|
71836851|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.17|||||TWO_SIDED|90.0|0.01|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.01|
71891917|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.3|5.2||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.2|-3.3|
71891918|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-9.4|6.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||6.4|-9.4|
71670178|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.62||0.4209||95.0|-1.77|0.76||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.||0.76|-1.77|0.4209
71836852|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|50.0|0.02|0.16||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.16|0.02|
71836853|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.08|||||TWO_SIDED|90.0|-0.04|0.3||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.30|-0.04|
71836854|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|50.0|0.06|0.24||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.24|0.06|
71836855|NCT04321031|143179823|SUPERIORITY||Risk Difference (RD)|0.13|||||TWO_SIDED|90.0|-0.01|0.44||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.44|-0.01|
71836856|NCT04321031|143179824|SUPERIORITY||Risk Difference (RD)|0.18|||||TWO_SIDED|90.0|0.05|0.31|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.31|0.05|
71754192|NCT02977403|143011676|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.0002|||||TWO_SIDED|95.0|-0.091|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.091|
71754193|NCT02977403|143011676|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.004|||||TWO_SIDED|95.0|-0.157|0.149||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.149|-0.157|
71754194|NCT02977403|143011677|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.01|||||TWO_SIDED|95.0|-0.092|0.071||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.071|-0.092|
71670179|NCT00380874|142857840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.54||0.9657||95.0|-1.06|1.11||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Last Observation Carried Forward (LOCF)endpoint.||1.11|-1.06|0.9657
71670180|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.5392||95.0|-0.24|0.12|||ANCOVA|||Cycle 1.||0.12|-0.24|0.5392
71670181|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5412||95.0|-0.3|0.57|||ANCOVA|||Cycle 2.||0.57|-0.30|0.5412
71670182|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.34||0.5358||95.0|-0.48|0.9|||ANCOVA|||Cycle 3.||0.90|-0.48|0.5358
71786782|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.69||0.954|TWO_SIDED|90.0|-1.2|1.2|||ANCOVA|||(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.2|-1.2|0.954
71786783|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.407|TWO_SIDED|90.0|-1.8|0.6|||ANCOVA|||(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||0.6|-1.8|0.407
71786784|NCT02310568|143071924|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.66||0.412|TWO_SIDED|90.0|-0.6|1.7|||ANCOVA|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.||1.7|-0.6|0.412
71786785|NCT02310568|143071925|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.45||0.856|TWO_SIDED|90.0|-2.2|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.7|-2.2|0.856
71786786|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.647|TWO_SIDED|90.0|-1.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.9|-1.7|0.647
71786787|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.817|TWO_SIDED|90.0|-3.0|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.3|-3.0|0.817
71670183|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.41||0.4059||95.0|-0.48|1.17|||ANCOVA|||Cycle 4.||1.17|-0.48|0.4059
71670184|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.2712||95.0|-0.44|1.52|||ANCOVA|||Cycle 5.||1.52|-0.44|0.2712
71670185|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.38||0.9181||95.0|-0.81|0.73|||ANCOVA|||Cycle 6.||0.73|-0.81|0.9181
71670186|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.42||0.4357||95.0|-0.52|1.17|||ANCOVA|||Cycle 7.||1.17|-0.52|0.4357
71670187|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.49||0.5103||95.0|-0.67|1.33|||ANCOVA|||||1.33|-0.67|0.5103
71670188|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.58||0.8499||95.0|-1.29|1.07|||ANCOVA|||Cycle 9.||1.07|-1.29|0.8499
71670189|NCT00380874|142857841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.39||0.7359||95.0|-0.9|0.64|||ANCOVA|||LOCF endpoint.||0.64|-0.90|0.7359
71786788|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.81||0.67|TWO_SIDED|90.0|-3.8|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.2|-3.8|0.670
71786789|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.74||0.736|TWO_SIDED|90.0|-2.3|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.5|-2.3|0.736
71786790|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.99||0.496|TWO_SIDED|90.0|-4.7|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.0|-4.7|0.496
71786791|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.72||0.575|TWO_SIDED|90.0|-1.9|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||3.8|-1.9|0.575
71836857|NCT04321031|143179824|SUPERIORITY||Risk Difference (RD)|0.23|||||TWO_SIDED|90.0|0.09|0.36|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.36|0.09|
71836858|NCT04321031|143179824|SUPERIORITY||Risk Difference (RD)|0.25|||||TWO_SIDED|90.0|0.1|0.38|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.38|0.10|
71836859|NCT04321031|143179824|SUPERIORITY||Risk Difference (RD)|0.27|||||TWO_SIDED|90.0|0.11|0.4|||||Reported values reflect a 90% Credible Interval rather than a 90% Confidence Interval.|The model was applied to the raw number of responders and non-responders utilizing a Bayesian methodology approach with non-informative priors as described in the SAP.||0.40|0.11|
71670190|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.2034||95.0|-0.06|0.29|||ANCOVA|||Burning Spontaneous Pain Cycle 3||0.29|-0.06|0.2034
71786792|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.67||0.362|TWO_SIDED|90.0|-1.2|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||4.3|-1.2|0.362
71786793|NCT02310568|143071925|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.9||0.771|TWO_SIDED|90.0|-3.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.||2.6|-3.7|0.771
71786794|NCT02310568|143071926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|90.0|0.45|1.26|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.26|0.45|
71786795|NCT02310568|143071926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|90.0|0.23|1.54|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||1.54|0.23|
71786796|NCT02310568|143071926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|90.0|0.69|2.32|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.32|0.69|
71786797|NCT02310568|143071926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||||TWO_SIDED|90.0|0.27|5.78|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||5.78|0.27|
71786798|NCT02310568|143071926|SUPERIORITY_OR_OTHER||Odds Ratio, log|2.13|||||TWO_SIDED|90.0|0.19|24.51|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||24.51|0.19|
71786799|NCT02310568|143071926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.16|2.09|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.||2.09|0.16|
71836860|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.14|||||TWO_SIDED|90.0|-0.04|0.36||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.36|-0.04|
71836861|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.35|||||TWO_SIDED|90.0|0.15|0.53||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.53|0.15|
71836862|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.26|||||TWO_SIDED|90.0|0.06|0.46||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.46|0.06|
71836863|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.48|||||TWO_SIDED|90.0|0.27|0.63||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.63|0.27|
71836864|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.16|||||TWO_SIDED|90.0|-0.03|0.38||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.38|-0.03|
71670191|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.3062||95.0|-0.4|0.13|||ANCOVA|||Burning Spontaneous Pain Cycle 4||0.13|-0.40|0.3062
71786800|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.801|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.801
71786801|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.416|TWO_SIDED|90.0|-0.5|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.5|0.416
71786802|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.634|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.634
71786803|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.47|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.470
71670192|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2787||95.0|-0.37|0.11|||ANCOVA|||Burning Spontaneous Pain Cycle 5||0.11|-0.37|0.2787
71786804|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.683|TWO_SIDED|90.0|-0.5|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.5|0.683
71786805|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.775|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.775
71786806|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.848|TWO_SIDED|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.4|0.848
71786807|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.23||0.49|TWO_SIDED|90.0|-0.2|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-0.2|0.490
71786808|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.433|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.433
71786809|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.796|TWO_SIDED|90.0|-0.4|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.4|0.796
71786810|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.624|TWO_SIDED|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.3|0.624
71786811|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.844|TWO_SIDED|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.5|0.844
71786812|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.5||0.743|TWO_SIDED|90.0|-0.7|1.0|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.7|0.743
71836865|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|90.0|0.18|0.58||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.58|0.18|
71670193|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.4124||95.0|-0.2|0.47|||ANCOVA|||Burning Spontaneous Pain Cycle 6||0.47|-0.20|0.4124
71670194|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.35||0.9541||95.0|-0.68|0.73|||ANCOVA|||Burning Spontaneous Pain Cycle 7||0.73|-0.68|0.9541
71836866|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|50.0|0.15|0.28||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.28|0.15|
71836867|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.22|||||TWO_SIDED|90.0|0.03|0.35||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.35|0.03|
71836868|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|50.0|0.16|0.32||||||Risk difference and 2-sided 50% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.32|0.16|
71836869|NCT04321031|143179825|SUPERIORITY||Risk Difference (RD)|0.24|||||TWO_SIDED|90.0|0.03|0.42||||||Risk difference and 2-sided 90% confidence interval for risk difference were calculated by using the observed placebo/corresponding BID rate and estimated odds ratio from the logistic regression model.||0.42|0.03|
71786813|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.48||0.356|TWO_SIDED|90.0|-1.3|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.3|0.356
71754195|NCT02977403|143011677|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.029|||||TWO_SIDED|95.0|-0.126|0.183||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.183|-0.126|
71786814|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|90.0|-0.2|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-0.2|0.180
71786815|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.589|TWO_SIDED|90.0|-0.6|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-0.6|0.589
71786816|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.873|TWO_SIDED|90.0|-0.8|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.8|0.873
71836870|NCT04556656|143179848|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.167|TWO_SIDED|95.0|-0.54|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.54|0.1670
71754196|NCT02977403|143011678|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.013|||||TWO_SIDED|95.0|-0.101|0.076||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.076|-0.101|
71754197|NCT02977403|143011678|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.273|0.06||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.060|-0.273|
71754198|NCT02977403|143011679|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.033|||||TWO_SIDED|95.0|-0.11|0.043||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.043|-0.110|
71754199|NCT02977403|143011679|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.166|||||TWO_SIDED|95.0|-0.335|0.003||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.003|-0.335|
71754200|NCT02977403|143011680|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.011|||||TWO_SIDED|95.0|-0.069|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.069|
71754201|NCT02977403|143011680|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.167|||||TWO_SIDED|95.0|-0.332|-0.002||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.002|-0.332|
71670195|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3383||95.0|-0.33|0.92|||ANOVA|||Burning Spontaneous Pain Cycle 8||0.92|-0.33|0.3383
71670196|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.39||0.8918||95.0|-0.84|0.74|||ANCOVA|||Burning Spontaneous Pain||0.74|-0.84|0.8918
71891919|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-4.2|1.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.4|-4.2|
71670197|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.26||0.9614||95.0|-0.54|0.51|||ANCOVA|||Burning Spontaneous Pain LOCF endpoint||0.51|-0.54|0.9614
71754202|NCT02977403|143011681|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.054|||||TWO_SIDED|95.0|-0.037|0.146||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.146|-0.037|
71754203|NCT02977403|143011681|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.019|||||TWO_SIDED|95.0|-0.127|0.09||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.090|-0.127|
71891920|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-5.9|0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.8|-5.9|
71891921|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.9|2.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.5|-2.9|
71891922|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-4.0|1.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.8|-4.0|
71891923|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|-3.1|||||TWO_SIDED|95.0|-7.0|0.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.9|-7.0|
71891924|NCT03193866|143305381|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.9|5.4||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||5.4|-2.9|
71891925|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|-5.5|||||TWO_SIDED|95.0|-8.1|-2.9||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-2.9|-8.1|
71670198|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.3022||95.0|-0.17|0.05|||ANCOVA|||Pressing Spontaneous Pain Cycle 2||0.05|-0.17|0.3022
71670199|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.3747||95.0|-0.04|0.12|||ANCOVA|||Pressing Spontaneous Pain Cycle 3||0.12|-0.04|0.3747
71670200|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.163||95.0|-0.4|0.07|||ANCOVA|||Pressing Spontaneous Pain Cycle 4||0.07|-0.40|0.1630
71670201|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9568||95.0|-0.12|0.11|||ANOVA|||Pressing Spontaneous Pain Cycle 5||0.11|-0.12|0.9568
71670202|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9793||95.0|-0.13|0.13|||ANCOVA|||Pressing Spontaneous Pain Cycle 6||0.13|-0.13|0.9793
71670203|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.25||0.885||95.0|-0.54|0.47|||ANCOVA|||Pressing Spontaneous Pain Cycle 7||0.47|-0.54|0.8850
71670204|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2199||95.0|-0.17|0.7|||ANCOVA|||Pressing Spontaneous Pain Cycle 8||0.70|-0.17|0.2199
71670205|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4017||95.0|-0.14|0.35|||ANCOVA|||Pressing Spontaneous Pain Cycle 9||0.35|-0.14|0.4017
71670206|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4113||95.0|-0.1|0.24|||ANCOVA|||Pressing Spontaneous Pain LOCF Endpoint||0.24|-0.10|0.4113
71670207|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3011||95.0|-0.06|0.02|||ANCOVA|||Paroxysmal Pain Cycle 3||0.02|-0.06|0.3011
71670208|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.4482||95.0|-0.26|0.12|||ANCOVA|||Paroxysmal Pain Cycle 4||0.12|-0.26|0.4482
71670209|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.3058||95.0|-0.31|0.1|||ANCOVA|||Paroxysmal Pain Cycle 5||0.10|-0.31|0.3058
71786817|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.667|TWO_SIDED|90.0|-0.6|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-0.6|0.667
71786818|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.548|TWO_SIDED|90.0|-0.5|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.5|0.548
71786819|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.567|TWO_SIDED|90.0|-1.0|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-1.0|0.567
71786820|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.208|TWO_SIDED|90.0|-0.2|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.2|0.208
71786821|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.858|TWO_SIDED|90.0|-1.2|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.2|0.858
71670210|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.3035||95.0|-0.38|0.12|||ANCOVA|||Paroxysmal Pain Cycle 6||0.12|-0.38|0.3035
71670211|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.23||0.9636||95.0|-0.46|0.48|||ANCOVA|||Paroxysmal Pain Cycle 7||0.48|-0.46|0.9636
71670212|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.35||0.366||95.0|-0.38|1.02|||ANCOVA|||Paroxysmal Pain Cycle 8||1.02|-0.38|0.3660
71670213|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.4093||95.0|-0.69|0.29|||ANCOVA|||Paroxysmal Pain Cycle 9||0.29|-0.69|0.4093
71670214|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5208||95.0|-0.39|0.2|||ANCOVA|||Paroxysmal Pain LOCF Endpoint||0.20|-0.39|0.5208
71670215|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9931||95.0|-0.17|0.17|||ANCOVA|||Evoke Pain Cycle 2||0.17|-0.17|0.9931
71670216|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.5867||95.0|-0.25|0.44|||ANCOVA|||Evoke Pain Cycle 3||0.44|-0.25|0.5867
71670217|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.2748||95.0|-0.37|0.11|||ANCOVA|||Evoke Pain Cycle 4||0.11|-0.37|0.2748
71670218|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.5521||95.0|-0.51|0.28|||ANCOVA|||Evoke Pain Cycle 5||0.28|-0.51|0.5521
71670219|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.39||0.6734||95.0|-0.96|0.62|||ANCOVA|||Evoke Pain Cycle 6||0.62|-0.96|0.6734
71670220|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.1214||95.0|-0.16|1.33|||ANCOVA|||Evoke Pain Cycle 7||1.33|-0.16|0.1214
71670221|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.51||0.1845||95.0|-0.34|1.72|||ANCOVA|||Evoke Pain Cycle 8||1.72|-0.34|0.1845
71670222|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.37||0.6863||95.0|-0.6|0.9|||ANCOVA|||Evoke Pain Cycle 9||0.90|-0.60|0.6863
71670223|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9273||95.0|-0.51|0.56|||ANCOVA|||Evoke Pain LOCF Endpoint||0.56|-0.51|0.9273
71670224|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.12||0.0416||95.0|0.01|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 2||0.50|0.01|0.0416
71786822|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.329|TWO_SIDED|90.0|-1.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-1.7|0.329
71786823|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.272|TWO_SIDED|90.0|-0.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.4|0.272
71786824|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.33||0.946|TWO_SIDED|90.0|-0.6|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.6|0.946
71786825|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.407|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.3|-0.8|0.407
71786826|NCT02310568|143071927|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.436|TWO_SIDED|90.0|-0.3|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.8|-0.3|0.436
71786827|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.325|TWO_SIDED|90.0|-0.6|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.1|-0.6|0.325
71786828|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.996|TWO_SIDED|90.0|-0.3|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.3|0.996
71786829|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.377|TWO_SIDED|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.6|0.377
71786830|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.291|TWO_SIDED|90.0|-0.7|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-0.7|0.291
71786831|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.925|TWO_SIDED|90.0|-0.4|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-0.4|0.925
71786832|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.39|TWO_SIDED|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.2|-0.7|0.390
71786833|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.502|TWO_SIDED|90.0|-0.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.7|0.502
71786834|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.29||0.348|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.348
71786835|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.16|TWO_SIDED|90.0|-1.0|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.1|-1.0|0.160
71786836|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.965|TWO_SIDED|90.0|-0.5|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.5|-0.5|0.965
71786837|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.389|TWO_SIDED|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-0.2|0.389
71670225|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1819||95.0|-0.1|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 3||0.50|-0.10|0.1819
71670226|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0331||95.0|0.03|0.7|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 4||0.70|0.03|0.0331
71670227|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0608||95.0|-0.02|0.83|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 5||0.83|-0.02|0.0608
71786838|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.34||0.433|TWO_SIDED|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.3|-0.8|0.433
71786839|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.94|TWO_SIDED|90.0|-0.9|0.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-0.9|0.940
71786840|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.757|TWO_SIDED|90.0|-1.0|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.7|-1.0|0.757
71786841|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.836|TWO_SIDED|90.0|-0.7|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-0.7|0.836
71786842|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.827|TWO_SIDED|90.0|-0.9|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-0.9|0.827
71786843|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.507|TWO_SIDED|90.0|-0.6|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.6|0.507
71786844|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.632
71786845|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.51||0.442|TWO_SIDED|90.0|-0.5|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.3|-0.5|0.442
71786846|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.643|TWO_SIDED|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-1.1|0.643
71786847|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.47||0.188|TWO_SIDED|90.0|-0.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.2|0.188
71836871|NCT04556656|143179849|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.162||0.1598|TWO_SIDED|95.0|-0.55|0.09|||Mixed Models Analysis|||In the mixed model for repeated measures (MMRM), change from baseline in TFC score was the dependent variable, and independent variables included treatment arm, baseline TFC, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level.||0.09|-0.55|0.1598
71670228|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.33||0.2809||95.0|-0.31|1.03|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 6||1.03|-0.31|0.2809
71670229|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.32||0.3445||95.0|-0.34|0.95|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 7||0.95|-0.34|0.3445
71670230|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.47||0.2806||95.0|-0.44|1.46|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 8||1.46|-0.44|0.2806
71786848|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.701|TWO_SIDED|90.0|-1.4|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.9|-1.4|0.701
71670231|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.49||0.5217||95.0|-0.68|1.33|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 9||1.33|-0.68|0.5217
71670232|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.34||0.3628||95.0|-0.37|1.0|||ANCOVA|||Parethesia/Dysesthesia Pain LOCF Endpoint||1.00|-0.37|0.3628
71786849|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63||0.271|TWO_SIDED|90.0|-1.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.4|-1.8|0.271
71786850|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.445|TWO_SIDED|90.0|-0.6|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-0.6|0.445
71670233|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.3557||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 2||0.01|-0.00|0.3557
71670234|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.2824||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 3||0.01|-0.00|0.2824
71786851|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.714|TWO_SIDED|90.0|-0.8|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.5|-0.8|0.714
71786852|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|90.0|-0.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.4|-0.8|0.515
71786853|NCT02310568|143071928|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.778|TWO_SIDED|90.0|-0.5|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||0.7|-0.5|0.778
71786854|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.93||0.562|TWO_SIDED|90.0|-2.1|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.0|-2.1|0.562
71786855|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.92||0.708|TWO_SIDED|90.0|-1.9|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.2|-1.9|0.708
71786856|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05||0.852|TWO_SIDED|90.0|-1.9|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.9|0.852
71670235|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5931||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 4||0.01|-0.01|0.5931
71670236|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.9865||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 5||0.01|-0.01|0.9865
71670237|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9854||95.0|-0.02|0.02|||ANCOVA|||Total Score Cycle 6||0.02|-0.02|0.9854
71670238|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3403||95.0|-0.01|0.04|||ANCOVA|||Total Score Cycle 7||0.04|-0.01|0.3403
71670239|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.2226||95.0|-0.01|0.05|||ANCOVA|||Total Score Cycle 8||0.05|-0.01|0.2226
71670240|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9694||95.0|-0.03|0.03|||ANCOVA|||Total Score Cycle 9||0.03|-0.03|0.9694
71670241|NCT00380874|142857842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8957||95.0|-0.02|0.02|||ANCOVA|||Total Score LOCF Endpoint||0.02|-0.02|0.8957
71786857|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.14||0.347|TWO_SIDED|90.0|-3.0|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.8|-3.0|0.347
71836872|NCT04556656|143179850|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.148||0.4544|TWO_SIDED|95.0|-0.4|0.18|||Mixed Models Analysis|||In the MMRM, change in cUHDRS score from baseline was the dependent variable, while independent variables included treatment arm, baseline cUHDRS, region, neuroleptic use or no use, baseline HD stage (HD1 and HD2), categorical week, and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. The unstructured covariance matrix was used for repeated measurements at patient level. No imputation was performed on missing data.||0.18|-0.4|0.4544
71836873|NCT04556656|143179851|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.156||0.0038|TWO_SIDED|95.0|0.15|0.76|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in cUHDRS score from baseline was the dependent variable and independent variables included treatment group, baseline cUHDRS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.76|0.15|0.0038
71836874|NCT04556656|143179851|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.179||0.0135|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis|||From baseline to Week 39||0.80|0.09|0.0135
71836875|NCT04556656|143179851|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.193||0.0351|TWO_SIDED|95.0|0.03|0.79|||Mixed Models Analysis|||From baseline to Week 52||0.79|0.03|0.0351
71836876|NCT04556656|143179851|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.197||0.1683|TWO_SIDED|95.0|-0.12|0.66|||Mixed Models Analysis|||From baseline to Week 65.||0.66|-0.12|0.1683
71836877|NCT04556656|143179851|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.223||0.5315|TWO_SIDED|95.0|-0.3|0.58|||Mixed Models Analysis|||From baseline to Week 78||0.58|-0.30|0.5315
71836878|NCT04556656|143179852|SUPERIORITY||Mean Difference (Final Values)|-21.15|STANDARD_ERROR_OF_MEAN|9.406||0.0253|TWO_SIDED|95.0|-39.66|-2.64|||Mixed Models Analysis||Negative change = improvement.|From baseline to Week 26. In the MMRM model, change in Q-Motor Finger Tapping IOI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Finger Tapping IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed.||-2.64|-39.66|0.0253
71836879|NCT04556656|143179852|SUPERIORITY||Mean Difference (Final Values)|-14.31|STANDARD_ERROR_OF_MEAN|9.853||0.1474|TWO_SIDED|95.0|-33.71|5.08|||Mixed Models Analysis|||From baseline to Week 52.||5.08|-33.71|0.1474
71836880|NCT04556656|143179852|SUPERIORITY||Mean Difference (Final Values)|-24.71|STANDARD_ERROR_OF_MEAN|10.185||0.0159|TWO_SIDED|95.0|-44.76|-4.67|||Mixed Models Analysis|||From baseline to Week 65.||-4.67|-44.76|0.0159
71836881|NCT04556656|143179852|SUPERIORITY||Mean Difference (Final Values)|-22.9|STANDARD_ERROR_OF_MEAN|10.38||0.0283|TWO_SIDED|95.0|-43.34|-2.45|||Mixed Models Analysis|||From baseline to Week 78.||-2.45|-43.34|0.0283
71836882|NCT04556656|143179853|SUPERIORITY||Mean Difference (Final Values)|-38.06|STANDARD_ERROR_OF_MEAN|10.999||0.0007|TWO_SIDED|95.0|-59.74|-16.37|||Mixed Models Analysis|||From baseline to Week 26. In MMRM model, change in Q-Motor Pronation/Supination ITI Mean from baseline was the dependent variable and independent variables included treatment group, baseline Q-Motor Pronation/Supination ITI Mean, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-16.37|-59.74|0.0007
71836883|NCT04556656|143179853|SUPERIORITY||Mean Difference (Final Values)|-20.21|STANDARD_ERROR_OF_MEAN|12.547||0.1087|TWO_SIDED|95.0|-44.95|4.53|||Mixed Models Analysis|||From baseline to Week 52.||4.53|-44.95|0.1087
71836884|NCT04556656|143179853|SUPERIORITY||Mean Difference (Final Values)|-23.92|STANDARD_ERROR_OF_MEAN|11.541||0.0395|TWO_SIDED|95.0|-46.68|-1.16|||Mixed Models Analysis|||From baseline to Week 65.||-1.16|-46.68|0.0395
71670242|NCT00380874|142857844|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.49||0.7489||95.0||||No multiple comparisons adjustment was necessary.|ANCOVA|Model terms include treatment, study center, and baseline score.|Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.|LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects \& 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.||||0.7489
71670243|NCT01451463|142857865|SUPERIORITY_OR_OTHER|||||||0.009|||||||t-test, 2 sided|||||||.009
71836885|NCT04556656|143179853|SUPERIORITY||Mean Difference (Final Values)|-22.23|STANDARD_ERROR_OF_MEAN|13.587||0.1038|TWO_SIDED|95.0|-49.08|4.61|||Mixed Models Analysis|||From baseline to Week 78.||4.61|-49.08|0.1038
71836886|NCT04556656|143179854|SUPERIORITY||Mean Difference (Final Values)|-30.38|STANDARD_ERROR_OF_MEAN|12.902||0.0193|TWO_SIDED|95.0|-55.78|-4.98|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in Pronation/Supination IOI Mean from BL was the dependent variable and independent variables included treatment group, BL Pronation/Supination IOI Mean, region, categorical week, baseline HD stage (HD1 and HD2), treatment by categorical week interaction, conc. use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||-4.98|-55.78|0.0193
71670244|NCT01451463|142857866|SUPERIORITY_OR_OTHER|||||||0.114|||||||t-test, 2 sided|||||||.114
71670245|NCT05479435|142857882|OTHER|||||||0.83|||||||Kruskal-Wallis|||||||0.830
71786858|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.14||0.759|TWO_SIDED|90.0|-2.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.2|0.759
71786859|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.28||0.574|TWO_SIDED|90.0|-2.9|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.9|0.574
71786860|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.09||0.831|TWO_SIDED|90.0|-2.1|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-2.1|0.831
71754204|NCT02977403|143011682|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.061|0.065||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.065|-0.061|
71754205|NCT02977403|143011682|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.086|||||TWO_SIDED|95.0|-0.215|0.042||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.042|-0.215|
71754206|NCT02977403|143011683|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.032|||||TWO_SIDED|95.0|-0.05|0.115||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.115|-0.05|
71754207|NCT02977403|143011683|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.248|0.058||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.058|-0.248|
71754208|NCT02977403|143011684|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.075|0.042||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.042|-0.075|
71754209|NCT02977403|143011684|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.025|||||TWO_SIDED|95.0|-0.13|0.18||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.180|-0.130|
71754210|NCT02977403|143011685|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.03|||||TWO_SIDED|95.0|-0.039|0.099||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).||||Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.099|-0.039|
71670246|NCT05479435|142857883|OTHER|||||||0.654|||||||ANCOVA|||||||0.654
71836887|NCT04556656|143179854|SUPERIORITY||Mean Difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|15.17||0.268|TWO_SIDED|95.0|-46.69|13.02|||Mixed Models Analysis|||From baseline to Week 52.||13.02|-46.69|0.2680
71836888|NCT04556656|143179854|SUPERIORITY||Mean Difference (Final Values)|-22.79|STANDARD_ERROR_OF_MEAN|14.829||0.1255|TWO_SIDED|95.0|-51.97|6.4|||Mixed Models Analysis|||From baseline to Week 65.||6.4|-51.97|0.1255
71836889|NCT04556656|143179854|SUPERIORITY||Mean Difference (Final Values)|-22.72|STANDARD_ERROR_OF_MEAN|17.777||0.2024|TWO_SIDED|95.0|-57.72|12.28|||Mixed Models Analysis|||From baseline to Week 78.||12.28|-57.72|0.2024
71670247|NCT05479435|142857884|OTHER|||||||0.803|||||||ANCOVA|||||||0.803
71670248|NCT05479435|142857885|OTHER|||||||0.398|||||||ANCOVA|||||||0.398
71670249|NCT05479435|142857886|OTHER|||||||0.132|||||||Kruskal-Wallis|||||||0.132
71836890|NCT04556656|143179855|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.179||0.2088|TWO_SIDED|95.0|-0.13|0.58|||Mixed Models Analysis|||"From baseline to Week 26.~In the MMRM model, change in UHDRS-TFC score from baseline was the dependent variable and independent variables included treatment group, Baseline UHDRS-TFC, region, categorical week, Baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data."||0.58|-0.13|0.2088
71670250|NCT05479435|142857887|OTHER|||||||0.991|||||||Kruskal-Wallis|||||||0.991
71670251|NCT05479435|142857888|OTHER|||||||0.278|||||||Kruskal-Wallis|||||||0.278
71670252|NCT05479435|142857889|OTHER|||||||0.479|||||||ANCOVA|||||||0.479
71670253|NCT05479435|142857890|OTHER|||||||0.849|||||||Kruskal-Wallis|||||||0.849
71670254|NCT05479435|142857891|OTHER|||||||0.504|||||||Kruskal-Wallis|||||||0.504
71836891|NCT04556656|143179855|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.188||0.2991|TWO_SIDED|95.0|-0.17|0.57|||Mixed Models Analysis|||From baseline to Week 39.||0.57|-0.17|0.2991
71670255|NCT05479435|142857892|OTHER|||||||0.017|||||||ANCOVA|||||||0.017
71670256|NCT05479435|142857893|OTHER|||||||0.025|||||||Kruskal-Wallis|||||||0.025
71670257|NCT05479435|142857894|OTHER|||||||0.016|||||||ANCOVA|||||||0.016
71670258|NCT05479435|142857895|OTHER|||||||0.041|||||||ANCOVA|||||||0.041
71670259|NCT05479435|142857896|OTHER|||||||0.352|||||||Kruskal-Wallis|||||||0.352
71670260|NCT05479435|142857897|OTHER|||||||0.39|||||||Kruskal-Wallis|||||||0.390
71670261|NCT05479435|142857898|OTHER|||||||0.928|||||||ANCOVA|||||||0.928
71670262|NCT05479435|142857899|OTHER|||||||0.558|||||||Kruskal-Wallis|||||||0.558
71670263|NCT05479435|142857900|OTHER|||||||0.133|||||||Kruskal-Wallis|||||||0.133
71670264|NCT05479435|142857901|OTHER|||||||0.367|||||||Kruskal-Wallis|||||||0.367
71670265|NCT05479435|142857902|OTHER|||||||0.631|||||||ANCOVA|||||||0.631
71670266|NCT05479435|142857903|OTHER|||||||0.056|||||||ANCOVA|||||||0.056
71670267|NCT05479435|142857904|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
71670268|NCT05479435|142857905|OTHER|||||||0.377|||||||ANCOVA|||||||0.377
71670269|NCT05479435|142857906|OTHER|||||||0.979|||||||ANCOVA|||||||0.979
71670270|NCT05479435|142857907|OTHER|||||||0.055|||||||ANCOVA|||||||0.055
71670271|NCT03851406|142857956|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
71670272|NCT03851406|142857957|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||> 0.99
71836892|NCT04556656|143179855|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.205||0.2116|TWO_SIDED|95.0|-0.15|0.66|||Mixed Models Analysis|||From baseline to Week 52.||0.66|-0.15|0.2116
71836893|NCT04556656|143179855|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.215||0.8242|TWO_SIDED|95.0|-0.38|0.47|||Mixed Models Analysis|||From baseline to Week 65.||0.47|-0.38|0.8242
71836894|NCT04556656|143179855|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.5918|TWO_SIDED|95.0|-0.33|0.58|||Mixed Models Analysis|||From baseline to Week 78.||0.58|-0.33|0.5918
71670273|NCT03851406|142857958|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||> 0.99
71670274|NCT03851406|142857958|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||> 0.99
71786861|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.705|TWO_SIDED|90.0|-1.4|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.4|0.705
71786862|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.24||0.6|TWO_SIDED|90.0|-2.7|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-2.7|0.600
71786863|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.23||0.848|TWO_SIDED|90.0|-2.3|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-2.3|0.848
71786864|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.24||0.237|TWO_SIDED|90.0|-0.6|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-0.6|0.237
71786865|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.4||0.224|TWO_SIDED|90.0|-4.0|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||0.6|-4.0|0.224
71786866|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.38||0.747|TWO_SIDED|90.0|-1.9|2.8|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.8|-1.9|0.747
71786867|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.37||0.764|TWO_SIDED|90.0|-2.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-2.8|0.764
71786868|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.22||0.487|TWO_SIDED|90.0|-1.3|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.0|-1.3|0.487
71786869|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.53||0.744|TWO_SIDED|90.0|-2.1|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-2.1|0.744
71786870|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.52||0.34|TWO_SIDED|90.0|-1.1|4.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.1|-1.1|0.340
71786871|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.36||0.477|TWO_SIDED|90.0|-3.3|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-3.3|0.477
71670275|NCT03851406|142857959|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
71670276|NCT03851406|142857959|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
71670277|NCT03851406|142857960|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.25
71670278|NCT03851406|142857960|OTHER|||||||0.63||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.63
71786872|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.51||0.482|TWO_SIDED|90.0|-1.5|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.7|-1.5|0.482
71836895|NCT04556656|143179856|SUPERIORITY||Mean Difference (Final Values)|3.16|STANDARD_ERROR_OF_MEAN|1.326||0.0178|TWO_SIDED|95.0|0.55|5.77|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SWR score from baseline was the dependent variable and independent variables included treatment group, baseline SWR, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, concomitant use of select medications and Treatment x Concomitant use of select medications, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||5.77|0.55|0.0178
71836896|NCT04556656|143179856|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.518||0.0576|TWO_SIDED|95.0|-0.09|5.88|||Mixed Models Analysis|||From baseline to Week 39.||5.88|-0.09|0.0576
71836897|NCT04556656|143179856|SUPERIORITY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.493||0.0418|TWO_SIDED|95.0|0.11|5.99|||Mixed Models Analysis|||From baseline to Week 52.||5.99|0.11|0.0418
71836898|NCT04556656|143179856|SUPERIORITY||Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|1.719||0.1775|TWO_SIDED|95.0|-1.06|5.71|||Mixed Models Analysis|||From baseline to Week 65.||5.71|-1.06|0.1775
71670279|NCT03851406|142857961|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
71786873|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.49||0.719|TWO_SIDED|90.0|-3.1|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-3.1|0.719
71786874|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.36||0.245|TWO_SIDED|90.0|-0.7|4.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.0|-0.7|0.245
71836899|NCT04556656|143179856|SUPERIORITY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.772||0.2627|TWO_SIDED|95.0|-1.5|5.48|||Mixed Models Analysis|||From baseline to Week 78.||5.48|-1.50|0.2627
71786875|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.93||0.586|TWO_SIDED|90.0|-2.3|4.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.4|-2.3|0.586
71786876|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.9||0.44|TWO_SIDED|90.0|-4.8|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.8|-4.8|0.440
71786877|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.75||0.159|TWO_SIDED|90.0|-0.5|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||5.6|-0.5|0.159
71786878|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.15||0.72|TWO_SIDED|90.0|-1.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.6|0.720
71786879|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.13||0.991|TWO_SIDED|90.0|-2.0|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.9|-2.0|0.991
71836900|NCT04556656|143179857|SUPERIORITY||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|0.712||0.1586|TWO_SIDED|95.0|-0.4|2.41|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.41|-0.4|0.1586
71836901|NCT04556656|143179857|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.701||0.2144|TWO_SIDED|95.0|-0.51|2.25|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.25|-0.51|0.2144
71670280|NCT03851406|142857961|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
71670281|NCT03851406|142857962|OTHER|||||||0.88||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.88
71670282|NCT03851406|142857962|OTHER|||||||0.25||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.25
71786880|NCT02310568|143071931|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.12||0.704|TWO_SIDED|90.0|-1.5|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.4|-1.5|0.704
71670283|NCT03851406|142857963|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||>0.99
71786881|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82||0.539|TWO_SIDED|90.0|-0.9|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.9|0.539
71786882|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.78||0.439|TWO_SIDED|90.0|-0.7|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.9|-0.7|0.439
71786883|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92||0.914|TWO_SIDED|90.0|-1.6|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.4|-1.6|0.914
71786884|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.86||0.892|TWO_SIDED|90.0|-1.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-1.3|0.892
71786885|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.82||0.463|TWO_SIDED|90.0|-0.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.0|-0.8|0.463
71670284|NCT03851406|142857963|OTHER||||||>|0.99||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||>0.99
71670285|NCT03851406|142857964|OTHER|||||||0.75||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.75
71670286|NCT03851406|142857964|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.38
71670287|NCT03511105|142857992|OTHER||Absolute Difference|-30.46|STANDARD_ERROR_OF_MEAN|48.662|||TWO_SIDED|95.0|-127.07|65.51|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI has been presented.|||65.51|-127.07|
71670288|NCT03511105|142857992|OTHER||Percentage change|8.73|STANDARD_ERROR_OF_MEAN|13.453|||TWO_SIDED|95.0|-21.41|31.3|||||Percentage change on GSK2798745 relative to placebo has been presented.|||31.30|-21.41|
71670289|NCT03511105|142857993|OTHER||Absolute Difference|-4.26|STANDARD_ERROR_OF_MEAN|13.679|||TWO_SIDED|95.0|-31.49|22.87|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||22.87|-31.49|
71670290|NCT03511105|142857993|OTHER||Percentage change|7.31|STANDARD_ERROR_OF_MEAN|22.837|||TWO_SIDED|95.0|-48.2|41.64|||||Percentage change on GSK2798745 relative to placebo has been presented.|||41.64|-48.20|
71670291|NCT03511105|142857994|OTHER||Absolute Difference|-0.06|STANDARD_ERROR_OF_MEAN|3.178|||TWO_SIDED|95.0|-6.28|6.2|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.|||6.20|-6.28|
71836902|NCT04556656|143179857|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.793||0.9119|TWO_SIDED|95.0|-1.65|1.48|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.48|-1.65|0.9119
71836903|NCT04556656|143179857|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.844||0.7339|TWO_SIDED|95.0|-1.38|1.95|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.95|-1.38|0.7339
71836904|NCT04556656|143179857|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.859||0.6213|TWO_SIDED|95.0|-1.27|2.12|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in SDMT score from baseline was the dependent variable and independent variables included treatment group, baseline SDMT, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||2.12|-1.27|0.6213
71836905|NCT04556656|143179858|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.777||0.8205|TWO_SIDED|95.0|-1.71|1.36|||Mixed Models Analysis|||From baseline to Week 26. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.36|-1.71|0.8205
71836906|NCT04556656|143179858|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.067||0.4028|TWO_SIDED|95.0|-3.0|1.21|||Mixed Models Analysis|||From baseline to Week 39. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.21|-3.0|0.4028
71836907|NCT04556656|143179858|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.051||0.7577|TWO_SIDED|95.0|-2.4|1.75|||Mixed Models Analysis|||From baseline to Week 52. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.75|-2.4|0.7577
71836908|NCT04556656|143179858|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|1.158||0.7605|TWO_SIDED|95.0|-2.64|1.93|||Mixed Models Analysis|||From baseline to Week 65. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||1.93|-2.64|0.7605
71836909|NCT04556656|143179858|SUPERIORITY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.323||0.6694|TWO_SIDED|95.0|-2.05|3.18|||Mixed Models Analysis|||From baseline to Week 78. In the MMRM model, change in TMS score from baseline was the dependent variable and independent variables included treatment group, baseline TMS, region, categorical week, baseline HD stage (HD1 and HD2), and treatment by categorical week interaction, with Kenward-Roger approximation for degrees of freedom. No imputation was performed on missing data.||3.18|-2.05|0.6694
71845497|NCT01274338|143205415|SUPERIORITY|||||||0.289||||||If low dose Ipi (LIP) vs. HDI is significant for OS at the 2.2% level, then we will compare high dose Ipi (HIP) vs. HDI at the 2.2% level.|Log Rank|Stratified logrank test||This study has a two-step hierarchical approach. In the first step, the low-dose Ipi (LIP) will be compared with HDI. If the low-dose Ipi is significantly better than HDI, then the high-dose Ipi will be compared with HDI as a second step. When comparing the two investigational treatment groups, the primary comparison will be an intent to treat analysis of recurrence free survival (RFS; First Co-primary Endpoint) and overall survival (OS; Second Co-primary Endpoint).||||0.289
71670292|NCT03511105|142857994|OTHER||Percentage change|0.1|STANDARD_ERROR_OF_MEAN|5.429|||TWO_SIDED|95.0|-11.15|10.16|||||Percentage change on GSK2798745 relative to placebo has been presented.|||10.16|-11.15|
71670293|NCT02810457|142858018|EQUIVALENCE|A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.|Ratio in ORR|0.96|||||TWO_SIDED|90.0|0.86|1.08||||||||1.08|0.86|
71670294|NCT02810457|142858019|OTHER|Ratio in ORR analysis of FKB238 versus Avastin.|Ratio in ORR|0.94|||||TWO_SIDED|90.0|0.83|1.06||||||Comparison between groups: Risk ratio in ORR at Week 19 by BICR.||1.06|0.83|
71670295|NCT02810457|142858020|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.82|1.16|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.16|0.82|
71670296|NCT02810457|142858021|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.96|1.45|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.45|0.96|
71670297|NCT02810457|142858022|OTHER|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.23|||||Treatment hazard ratio \<1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.||1.23|0.74|
71670298|NCT02810457|142858023|OTHER|Comparison between arms: Odds ratio.|Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.58|||||Odds ratio \>1 favors FKB238.|The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).||1.58|0.64|
71670299|NCT04231825|142858043|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
71836910|NCT03498651|143179859|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|1.04|1.16|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||1.16|1.04|
71836911|NCT03498651|143179859|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.43|0.2|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.20|-0.43|
71836912|NCT03498651|143179860|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.69|-0.57|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.57|-0.69|
71836913|NCT03498651|143179860|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.26|
71836914|NCT03498651|143179861|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|0.42|0.54|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.||"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|0.54|0.42|
71836915|NCT03498651|143179861|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.23|0.39|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.39|-0.23|
71670300|NCT04231825|142858044|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
71670301|NCT04231825|142858045|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.80
71670302|NCT04231825|142858046|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.02
71670303|NCT04231825|142858047|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71670304|NCT02019472|142858048|SUPERIORITY_OR_OTHER||LS mean difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.07|-0.46|||ANCOVA|||||-0.46|-1.07|< 0.001
71670305|NCT02019472|142858048|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.39|||=|0.013|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||||-0.08|-0.69|=0.013
71670306|NCT02019472|142858049|SUPERIORITY_OR_OTHER||Percentage Difference|-4.8||||0.306|TWO_SIDED|95.0|-14.1|4.4|||Cochran-Mantel-Haenszel|||||4.4|-14.1|0.306
71670307|NCT02019472|142858049|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.464|TWO_SIDED|95.0|-6.0|13.1|||Cochran-Mantel-Haenszel|||||13.1|-6|0.464
71670308|NCT02019472|142858050|SUPERIORITY_OR_OTHER||Percentage Difference|5.4||||0.086|TWO_SIDED|95.0|-0.7|11.4|||Cochran-Mantel-Haenszel|||||11.4|-0.7|0.086
71670309|NCT02019472|142858050|SUPERIORITY_OR_OTHER||Percentage Difference|12.8|||<|0.001|TWO_SIDED|95.0|5.9|19.7|||Cochran-Mantel-Haenszel|||||19.7|5.9|< 0.001
71836916|NCT03498651|143179862|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_DEVIATION|0.02|||TWO_SIDED|95.0|-0.6|-0.51|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.51|-0.60|
71836917|NCT03498651|143179862|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13|||TWO_SIDED|95.0|-0.23|0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.27|-0.23|
71891926|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-10.9|-1.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-1.0|-10.9|
71891927|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.0|-0.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||-0.8|-4.0|
71891928|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.1|1.5||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||1.5|-2.1|
71891929|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.2|0.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||0.6|-2.2|
71891930|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-0.3|2.8||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||2.8|-0.3|
71670310|NCT02019472|142858051|SUPERIORITY_OR_OTHER||Percentage Difference|-2.7||||0.603|TWO_SIDED|95.0|-12.8|7.4|||Cochran-Mantel-Haenszel|||||7.4|-12.8|0.603
71670311|NCT02019472|142858051|SUPERIORITY_OR_OTHER||Percentage Difference|2.4||||0.644|TWO_SIDED|95.0|-7.6|12.3|||Cochran-Mantel-Haenszel|||||12.3|-7.6|0.644
71891931|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|0.9|4.6||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.6|0.9|
71670312|NCT03861390|142858052|OTHER|||||||0.24||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.24
71670313|NCT03861390|142858053|OTHER|||||||0.17||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.17
71670314|NCT03861390|142858054|OTHER|||||||0.7||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.70
71670315|NCT03861390|142858054|OTHER|||||||0.37||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.37
71670316|NCT03861390|142858055|OTHER|||||||0.77||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.77
71670317|NCT03861390|142858055|OTHER|||||||0.48||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.48
71670318|NCT03861390|142858056|OTHER|||||||0.96||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.96
71786886|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.611|TWO_SIDED|90.0|-2.1|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.1|-2.1|0.611
71786887|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.88||0.321|TWO_SIDED|90.0|-0.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.4|-0.6|0.321
71786888|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.85||0.294|TWO_SIDED|90.0|-0.5|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-0.5|0.294
71786889|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.99||0.987|TWO_SIDED|90.0|-1.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-1.7|0.987
71786890|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.04||0.599|TWO_SIDED|90.0|-1.2|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.3|-1.2|0.599
71786891|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.322|TWO_SIDED|90.0|-0.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.6|-0.7|0.322
71786892|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.17||0.704|TWO_SIDED|90.0|-2.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.5|-2.4|0.704
71786893|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.38||0.804|TWO_SIDED|90.0|-2.0|2.7|||LS Mean Difference|||(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-2.0|0.804
71786894|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.38||0.559|TWO_SIDED|90.0|-3.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-3.2|0.559
71786895|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.27||0.369|TWO_SIDED|90.0|-1.0|3.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.4|-1.0|0.369
71786896|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.56||0.313|TWO_SIDED|90.0|-1.1|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-1.1|0.313
71845498|NCT06072170|143205459|OTHER|Proportionality analysis was done using a power model.|Slope|0.829|||||TWO_SIDED|90.0|0.659|0.998||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.998|0.659|
71670319|NCT03861390|142858056|OTHER|||||||0.91||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.91
71670320|NCT03861390|142858057|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.46
71670321|NCT03861390|142858057|OTHER|||||||0.46||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.46
71786897|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.56||0.56|TWO_SIDED|90.0|-1.8|3.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.6|-1.8|0.560
71845499|NCT06072170|143205459|OTHER|Proportionality analysis was done using a power model.|Slope|0.843|||||TWO_SIDED|90.0|0.713|0.973||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.973|0.713|
71786898|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.43||0.635|TWO_SIDED|90.0|-1.8|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.2|-1.8|0.635
71786899|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.62||0.538|TWO_SIDED|90.0|-1.8|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.8|-1.8|0.538
71786900|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.6||0.942|TWO_SIDED|90.0|-2.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.9|-2.7|0.942
71786901|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.5||0.555|TWO_SIDED|90.0|-1.7|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||3.5|-1.7|0.555
71786902|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.96||0.728|TWO_SIDED|90.0|-4.1|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||2.7|-4.1|0.728
71786903|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.95||0.362|TWO_SIDED|90.0|-5.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||1.6|-5.2|0.362
71845500|NCT06072170|143205459|OTHER|Proportionality analysis was done using a power model.|Slope|0.811|||||TWO_SIDED|90.0|0.637|0.984||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.984|0.637|
71845501|NCT06072170|143205459|OTHER|Proportionality analysis was done using a power model.|Slope|0.814|||||TWO_SIDED|90.0|0.633|0.994||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||0.994|0.633|
71670322|NCT03861390|142858058|OTHER|||||||0.82||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.82
71670323|NCT03861390|142858058|OTHER|The a priori threshold for statistical significance is \< 0.05.||||||0.99|||||||Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.99
71670324|NCT03861390|142858059|OTHER|||||||0.38||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.38
71670325|NCT03861390|142858059|OTHER|||||||0.84||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.84
71670326|NCT03861390|142858060|OTHER|||||||0.49||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||4 hours post WSP exposure||||0.49
71670327|NCT03861390|142858060|OTHER|||||||0.52||||||The a priori threshold for statistical significance is \< 0.05.|Wilcoxon (Mann-Whitney)|||24 hours post WSP exposure||||0.52
71670328|NCT01217112|142858062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.044||0.766|TWO_SIDED|90.0|-0.09|0.06|||ANCOVA|||Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.09|0.766
71670329|NCT01217112|142858062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.043||0.424|TWO_SIDED|90.0|-0.04|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.04|0.424
71786904|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|1.81||0.538|TWO_SIDED|90.0|-2.0|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).||4.3|-2.0|0.538
71786905|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.949|TWO_SIDED|90.0|-2.0|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.8|-2.0|0.949
71670330|NCT01217112|142858062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.041||0.412|TWO_SIDED|90.0|-0.1|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.10|0.412
71670331|NCT01217112|142858062|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.043||0.668|TWO_SIDED|90.0|-0.05|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.05|0.668
71670332|NCT01217112|142858063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.046||0.978|TWO_SIDED|90.0|-0.08|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.08|0.978
71670333|NCT01217112|142858063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.045||0.864|TWO_SIDED|90.0|-0.08|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.08|0.864
71670334|NCT01217112|142858063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.537|TWO_SIDED|90.0|-0.12|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-0.12|0.537
71670335|NCT01217112|142858063|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.045||0.26|TWO_SIDED|90.0|-0.02|0.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.13|-0.02|0.260
71670336|NCT01217112|142858064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.088|TWO_SIDED|90.0|-0.61|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.61|0.088
71670337|NCT01217112|142858064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.177||0.583|TWO_SIDED|90.0|-0.2|0.39|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.39|-0.20|0.583
71670338|NCT01217112|142858064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.388|TWO_SIDED|90.0|-0.14|0.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.43|-0.14|0.388
71670339|NCT01217112|142858064|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.17||0.58|TWO_SIDED|90.0|-0.19|0.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.38|-0.19|0.580
71670340|NCT01217112|142858065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.198||0.829|TWO_SIDED|90.0|-0.29|0.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.37|-0.29|0.829
71845502|NCT06072170|143205459|OTHER|Proportionality analysis was done using a power model.|Slope|0.88|||||TWO_SIDED|90.0|0.72|1.039||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.039|0.720|
71670341|NCT01217112|142858065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.196||0.575|TWO_SIDED|90.0|-0.22|0.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.44|-0.22|0.575
71670342|NCT01217112|142858065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.203||0.356|TWO_SIDED|90.0|-0.15|0.53|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.53|-0.15|0.356
71670343|NCT01217112|142858065|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.188||0.472|TWO_SIDED|90.0|-0.18|0.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.45|-0.18|0.472
71670344|NCT01217112|142858066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.181||0.115|TWO_SIDED|90.0|-0.59|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.59|0.115
71670345|NCT01217112|142858066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.177||0.782|TWO_SIDED|90.0|-0.25|0.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.35|-0.25|0.782
71670346|NCT01217112|142858066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.173||0.902|TWO_SIDED|90.0|-0.27|0.31|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.31|-0.27|0.902
71670347|NCT01217112|142858066|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.166||0.993|TWO_SIDED|90.0|-0.28|0.28|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.28|-0.28|0.993
71670348|NCT01217112|142858067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.143||0.956|TWO_SIDED|90.0|-0.23|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.23|0.956
71670349|NCT01217112|142858067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.144||0.705|TWO_SIDED|90.0|-0.19|0.3|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.30|-0.19|0.705
71670350|NCT01217112|142858067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.148||0.466|TWO_SIDED|90.0|-0.14|0.36|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.36|-0.14|0.466
71670351|NCT01217112|142858067|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.136||0.876|TWO_SIDED|90.0|-0.21|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.25|-0.21|0.876
71845503|NCT06072170|143205461|OTHER|Proportionality analysis was done using a power model.|Slope|0.946|||||TWO_SIDED|90.0|0.768|1.123||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.123|0.768|
71836918|NCT03498651|143179863|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.46|-0.37|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.37|-0.46|
71836919|NCT03498651|143179863|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.14|||TWO_SIDED|95.0|-0.23|0.32|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.32|-0.23|
71836920|NCT03498651|143179864|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|0.03|||TWO_SIDED|95.0|-0.39|-0.27|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% bootstrap confidence interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation)."||-0.27|-0.39|
71836921|NCT03498651|143179864|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.16|||TWO_SIDED|95.0|-0.14|0.48|||Mixed Models Analysis|We compared the two groups in a piecewise linear multilevel model (one slope during treatment, one during follow-up), controlling for income and age.|From the model (run in Bayesian with non-informative priors), we report the between-group SMD (with empirical SD \& 95% HPD credible interval) at Session 5 (at mean income \& age), adjusted for baseline differences \& using pooled baseline SD.|"Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach)."||0.48|-0.14|
71836922|NCT03138512|143179876|SUPERIORITY||Cox Proportional Hazard|0.95||||0.6676||95.0|0.75|1.2|||Log Rank|||||1.20|0.75|0.6676
71836923|NCT03138512|143179876|SUPERIORITY||Cox Proportional Hazard|0.93||||0.6556||95.0|0.67|1.28|||Log Rank|||||1.28|0.67|0.6556
71836924|NCT03138512|143179877|SUPERIORITY||Cox Proportional Hazard|1.26||||0.2436||95.0|0.85|1.85|||Log Rank|||Treatment Part A||1.85|0.85|0.2436
71836925|NCT03138512|143179877|SUPERIORITY||Cox Proportional Hazard|1.36||||0.45||95.0|0.61|3.07|||Log Rank|||Treatment Part B||3.07|0.61|0.4500
71836926|NCT03138512|143179879|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.89|1.67||||||||1.67|0.89|
71836927|NCT03138512|143179880|SUPERIORITY||Cox Proportional Hazard|0.75||||||95.0|0.33|1.68||||||||1.68|0.33|
71836928|NCT03332017|143179889|SUPERIORITY|||||||0.0017|||||||Cochran-Mantel-Haenszel|P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.||||||0.0017
71836929|NCT04401800|143179933|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||||||0.0002
71836930|NCT04401800|143179935|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||||||< 0.0001
71836931|NCT04401800|143179936|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
71836932|NCT04401800|143179936|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||< 0.0001
71836933|NCT04401800|143179937|SUPERIORITY||||||<|0.0001|||||||Binomial exact test|||ORR as Assessed by the Investigator||||< 0.0001
71836934|NCT04401800|143179937|SUPERIORITY|||||||0.0002|||||||Binomial exact test|||ORR as Assessed by Central Site Imaging Facility||||0.0002
71845504|NCT06072170|143205461|OTHER|Proportionality analysis was done using a power model.|Slope|0.978|||||TWO_SIDED|90.0|0.821|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.821|
71845505|NCT06072170|143205461|OTHER|Proportionality analysis was done using a power model.|Slope|1.075|||||TWO_SIDED|90.0|0.901|1.249||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.249|0.901|
71845506|NCT06072170|143205461|OTHER|Proportionality analysis was done using a power model.|Slope|1.046|||||TWO_SIDED|90.0|0.87|1.222||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.222|0.870|
71845507|NCT06072170|143205461|OTHER|Proportionality analysis was done using a power model.|Slope|1.011|||||TWO_SIDED|90.0|0.844|1.178||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.178|0.844|
71845508|NCT06072170|143205462|OTHER|Proportionality analysis was done using a power model.|Slope|0.959|||||TWO_SIDED|90.0|0.775|1.143||||||Statistical Analysis for Dose-Proportionality of Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.143|0.775|
71845509|NCT06072170|143205462|OTHER|Proportionality analysis was done using a power model.|Slope|0.974|||||TWO_SIDED|90.0|0.815|1.134||||||Statistical Analysis for Dose-Proportionality of 7-Hydroxy-Mitragynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.134|0.815|
71670352|NCT01217112|142858068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.034||0.408|TWO_SIDED|90.0|-0.03|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.03|0.408
71670353|NCT01217112|142858068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.714|TWO_SIDED|90.0|-0.04|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.07|-0.04|0.714
71670354|NCT01217112|142858068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.032||0.267|TWO_SIDED|90.0|-0.09|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.09|0.267
71670355|NCT01217112|142858068|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.032||0.484|TWO_SIDED|90.0|-0.03|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.03|0.484
71670356|NCT01217112|142858069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.039||0.56|TWO_SIDED|90.0|-0.09|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.09|0.560
71670357|NCT01217112|142858069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.037||0.956|TWO_SIDED|90.0|-0.06|0.06|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.06|-0.06|0.956
71670358|NCT01217112|142858069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.039||0.403|TWO_SIDED|90.0|-0.1|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.10|0.403
71670359|NCT01217112|142858069|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.617|TWO_SIDED|90.0|-0.04|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.08|-0.04|0.617
71670360|NCT01217112|142858070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.108||0.815|TWO_SIDED|90.0|-0.16|0.21|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.21|-0.16|0.815
71670361|NCT01217112|142858070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.105||0.418|TWO_SIDED|90.0|-0.09|0.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.26|-0.09|0.418
71670362|NCT01217112|142858070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.111||0.236|TWO_SIDED|90.0|-0.05|0.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.32|-0.05|0.236
71670363|NCT01217112|142858070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.103||0.556|TWO_SIDED|90.0|-0.11|0.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.23|-0.11|0.556
71670364|NCT01217112|142858071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.241||0.329|TWO_SIDED|90.0|-0.64|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.64|0.329
71670365|NCT01217112|142858071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.236||0.232|TWO_SIDED|90.0|-0.11|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.11|0.232
71754211|NCT02977403|143011685|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.143|||||TWO_SIDED|95.0|-0.335|0.049||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.049|-0.335|
71754212|NCT02977403|143011686|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.016|||||TWO_SIDED|95.0|-0.097|0.066||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.066|-0.097|
71754213|NCT02977403|143011686|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.162|||||TWO_SIDED|95.0|-0.314|-0.01||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||-0.01|-0.314|
71670366|NCT01217112|142858071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.222||0.164|TWO_SIDED|90.0|-0.06|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.68|-0.06|0.164
71670367|NCT01217112|142858071|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.232||0.302|TWO_SIDED|90.0|-0.15|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-0.15|0.302
71670368|NCT01217112|142858072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.614|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.614
71670369|NCT01217112|142858072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.227||0.669|TWO_SIDED|90.0|-0.28|0.48|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.48|-0.28|0.669
71786906|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.09||0.708|TWO_SIDED|90.0|-2.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||1.5|-2.3|0.708
71670370|NCT01217112|142858072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.24||0.621|TWO_SIDED|90.0|-0.28|0.52|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.52|-0.28|0.621
71670371|NCT01217112|142858072|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.222||0.867|TWO_SIDED|90.0|-0.33|0.41|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.41|-0.33|0.867
71670372|NCT01217112|142858073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|2.624||0.335|TWO_SIDED|90.0|-1.84|6.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.95|-1.84|0.335
71786907|NCT02310568|143071932|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07||0.752|TWO_SIDED|90.0|-1.5|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\*treatment and baseline\*week interaction as fixed effects, week repeated in each participant as repeated effect.||2.2|-1.5|0.752
71786908|NCT02310568|143071933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|90.0|0.37|2.45|||Regression, Logistic|||(PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||2.45|0.37|
71786909|NCT02310568|143071933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|90.0|0.39|6.88|||Regression, Logistic|||(PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||6.88|0.39|
71670373|NCT01217112|142858073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.36|STANDARD_ERROR_OF_MEAN|2.545||0.358|TWO_SIDED|90.0|-1.9|6.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.62|-1.90|0.358
71786910|NCT02310568|143071933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|90.0|0.23|1.49|||Regression, Logistic|||(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).||1.49|0.23|
71891932|NCT03193866|143305382|SUPERIORITY||Mean Difference (Final Values)|2.1|||||TWO_SIDED|95.0|0.2|4.0||||||Data shown are adjusted mean differences, stratified by DMT line with rituximab as reference, from multivariable linear regression adjusted for age, sex, year of treatment start, country of birth, geographical region, education level, duration since MS diagnosis, baseline EDSS and MSIS-29 scores, history of serious infection, malignancy, major adverse cardiovascular event, arrhythmia, use of antidepressants, diabetes. Confidence intervals are based on robust (Huber-White) standard errors.||4.0|0.2|
71891933|NCT04971226|143305389|SUPERIORITY||Risk Difference (RD)|18.88|||<|0.001|TWO_SIDED|95.0|9.59|28.17|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|28.17|9.59|<0.001
71786911|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.158||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.||||0.158
71786912|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.025||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.||||0.025
71786913|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.007||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.||||0.007
71670374|NCT01217112|142858073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.406||0.9|TWO_SIDED|90.0|-3.72|4.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.33|-3.72|0.900
71786914|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.061||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.||||0.061
71786915|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.107||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.||||0.107
71786916|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.237||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.||||0.237
71786917|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.497||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.||||0.497
71786918|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.704||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.||||0.704
71670375|NCT01217112|142858073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|2.486||0.019|TWO_SIDED|90.0|1.86|10.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.19|1.86|0.019
71786919|NCT02989194|143071939|SUPERIORITY|Descriptive statistics. All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.585||||||All p-values are presented for informational purposes only, there were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.||||0.585
71670376|NCT01217112|142858074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.245||0.325|TWO_SIDED|90.0|-0.65|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.65|0.325
71670377|NCT01217112|142858074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.238||0.438|TWO_SIDED|90.0|-0.21|0.59|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.59|-0.21|0.438
71786920|NCT02989194|143071950|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.083|||||||t-test, 2 sided|||A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.||||0.083
71786921|NCT02989194|143071951|SUPERIORITY|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level.||||||0.169||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|t-test, 2 sided|||The null hypothesis was defined as no treatment difference.||||0.169
71670378|NCT01217112|142858074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.226||0.701|TWO_SIDED|90.0|-0.29|0.47|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.47|-0.29|0.701
71754214|NCT02977403|143011687|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.053|||||TWO_SIDED|95.0|-0.051|0.156||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.156|-0.051|
71754215|NCT02977403|143011687|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.07|||||TWO_SIDED|95.0|-0.251|0.111||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.111|-0.251|
71754216|NCT02977403|143011688|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.015|||||TWO_SIDED|95.0|-0.061|0.091||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.091|-0.061|
71754217|NCT02977403|143011688|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.108|||||TWO_SIDED|95.0|-0.26|0.044||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.044|-0.260|
71845510|NCT06072170|143205462|OTHER|Proportionality analysis was done using a power model.|Slope|1.036|||||TWO_SIDED|90.0|0.866|1.207||||||Statistical Analysis for Dose-Proportionality of Paynantheine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.207|0.866|
71670379|NCT01217112|142858074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.232||0.624|TWO_SIDED|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.27|-0.50|0.624
71670380|NCT01217112|142858075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.058||0.233|TWO_SIDED|90.0|-0.17|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.17|0.233
71670381|NCT01217112|142858075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.056||0.727|TWO_SIDED|90.0|-0.07|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.07|0.727
71670382|NCT01217112|142858075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.593|TWO_SIDED|90.0|-0.06|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.06|0.593
71670383|NCT01217112|142858075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.075|TWO_SIDED|90.0|-0.2|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.01|-0.20|0.075
71670384|NCT01217112|142858076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.084||0.236|TWO_SIDED|90.0|-0.04|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.04|0.236
71670385|NCT01217112|142858076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.082||0.579|TWO_SIDED|90.0|-0.09|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.09|0.579
71786922|NCT02989194|143071952|SUPERIORITY|Descriptive Statistics. Statistical comparisons were performed using log rank test.||||||0.028||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|||Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.|All statistical comparisons were performed using 2-sided tests at the 0.05 significance level, unless specifically stated otherwise. All null hypotheses were defined as no treatment difference. All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|||0.028
71670386|NCT01217112|142858076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.077||0.837|TWO_SIDED|90.0|-0.15|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.11|-0.15|0.837
71786923|NCT02989194|143071954|EQUIVALENCE|Descriptive Statistics. All statistical comparisons were performed at the 0.05 significance level.||||||0.173||||||All p-values are presented for informational purposes only; there were no adjustments for multiple comparisons.|Log Rank|Kaplan-Meier methods were used to calculate the median time, 25th percentile and 75th percentile.||All null hypotheses were defined as no treatment difference.||||0.173
71786924|NCT01635101|143071960|OTHER||LS Mean Difference|-11.8||||0.736|TWO_SIDED|97.5|-91.0|67.3|||ANOVA|||Difference in Least Squares (LS) Means||67.3|-91.0|0.736
71786925|NCT01635101|143071960|OTHER||LS Mean Difference|1.4||||0.967|TWO_SIDED|97.5|-75.9|78.7|||ANOVA|||LS Mean Difference||78.7|-75.9|0.967
71786926|NCT03232801|143071970|SUPERIORITY||chi-squared|4.86||||0.027|TWO_SIDED||||||Chi-squared|||||||0.027
71786927|NCT03232801|143071971|SUPERIORITY||chi-squared|0.45||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
71845511|NCT06072170|143205462|OTHER|Proportionality analysis was done using a power model.|Slope|0.967|||||TWO_SIDED|90.0|0.79|1.145||||||Statistical Analysis for Dose-Proportionality of Speciogynine Pharmacokinetic Parameters (Pharmacokinetic Population)||1.145|0.790|
71670387|NCT01217112|142858076|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.467|TWO_SIDED|90.0|-0.08|0.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.19|-0.08|0.467
71786928|NCT01577329|143072016|SUPERIORITY_OR_OTHER|||||||0.05||||||This is a calculated P value and was not adjusted for multiple comparisons.|ANOVA|||This is a calculated P value comparing two groups at baseline and follow-up||||0.05
71786929|NCT03395886|143072035|OTHER|||||||0.831|||||||Chi-squared|||Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.||||0.831
71786930|NCT03395886|143072036|OTHER|||||||0.8|||||||Generalized estimating equations|||||||0.800
71786931|NCT02557698|143072052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.002|TWO_SIDED|95.0|-3.1|-0.8|||t-test, 2 sided|||H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groups||-0.8|-3.1|0.002
71786932|NCT02557698|143072053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.5|-1.2|||t-test, 2 sided|||||-1.2|-3.5|<0.001
71786933|NCT02557698|143072054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.024|TWO_SIDED|95.0|-3.2|-0.2|||t-test, 2 sided|||||-0.2|-3.2|0.024
71786934|NCT02557698|143072055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.017|TWO_SIDED|95.0|-3.1|-0.3|||t-test, 2 sided|||||-0.3|-3.1|0.017
71786935|NCT02557698|143072056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.964|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.964
71670388|NCT01217112|142858077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.613||0.533|TWO_SIDED|90.0|-1.41|0.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.64|-1.41|0.533
71786936|NCT02557698|143072057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.025|TWO_SIDED|95.0|0.5|8.2|||t-test, 2 sided|||||8.2|0.5|0.025
71786937|NCT02557698|143072058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.458|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||||1.1|-2.5|0.458
71786938|NCT02557698|143072059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.066|TWO_SIDED|95.0|-3.5|0.1|||t-test, 2 sided|||||0.1|-3.5|0.066
71786939|NCT02557698|143072060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.171|TWO_SIDED|95.0|-13.7|2.5|||t-test, 2 sided|||||2.5|-13.7|0.171
71786940|NCT02557698|143072061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5||||0.059|TWO_SIDED|95.0|-15.3|0.3|||t-test, 2 sided|||||0.3|-15.3|0.059
71786941|NCT02557698|143072062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4|TWO_SIDED|95.0|-0.2|0.5|||t-test, 2 sided|||||0.5|-0.2|0.400
71786942|NCT02557698|143072063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.4|||t-test, 2 sided|||||0.4|-0.1|0.100
71786943|NCT02557698|143072064|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71786944|NCT02557698|143072065|SUPERIORITY_OR_OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
71786945|NCT02557698|143072066|SUPERIORITY_OR_OTHER|||||||0.822|||||||Wilcoxon (Mann-Whitney)|||||||0.822
71786946|NCT02557698|143072067|SUPERIORITY_OR_OTHER|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
71786947|NCT02557698|143072068|SUPERIORITY_OR_OTHER|||||||0.259|||||||Wilcoxon (Mann-Whitney)|||||||0.259
71670389|NCT01217112|142858077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.585||0.804|TWO_SIDED|90.0|-0.84|1.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.13|-0.84|0.804
71786948|NCT02557698|143072069|SUPERIORITY_OR_OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||||||0.581
71786949|NCT02557698|143072070|SUPERIORITY_OR_OTHER|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||||||0.182
71786950|NCT02557698|143072071|SUPERIORITY_OR_OTHER|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||||||0.759
71786951|NCT02557698|143072072|SUPERIORITY_OR_OTHER|||||||0.831|||||||Wilcoxon (Mann-Whitney)|||||||0.831
71786952|NCT02557698|143072073|SUPERIORITY_OR_OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
71786953|NCT02557698|143072074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.07|TWO_SIDED|95.0|-0.3|7.4|||t-test, 2 sided|||||7.4|-0.3|0.07
71786954|NCT02557698|143072075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1||||0.029|TWO_SIDED|95.0|0.4|7.7|||t-test, 2 sided|||||7.7|0.4|0.029
71786955|NCT02557698|143072076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.325|TWO_SIDED|95.0|-1.8|0.6|||t-test, 2 sided|||||0.6|-1.8|0.325
71786956|NCT02557698|143072077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.365|TWO_SIDED|95.0|-2.6|0.9|||t-test, 2 sided|||||0.9|-2.6|0.365
71786957|NCT02557698|143072078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.143|TWO_SIDED|95.0|-8.5|1.3|||t-test, 2 sided|||||1.3|-8.5|0.143
71786958|NCT02557698|143072079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.662|TWO_SIDED|95.0|-6.5|4.2|||t-test, 2 sided|||||4.2|-6.5|0.662
71786959|NCT02557698|143072080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.326|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||||0.1|-0.4|0.326
71786960|NCT02557698|143072081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.687|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.687
71786961|NCT02289690|143072082|OTHER||RP2D for veliparib in mg BID for 14 days|240.0|||||TWO_SIDED||||||||The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL\*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.|A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.||||
71786962|NCT02289690|143072098|SUPERIORITY||Hazard Ratio (HR)|0.665||||0.059|TWO_SIDED|80.0|0.503|0.88|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"The primary efficacy analysis in the Phase 2 portion of the study was the comparison of PFS among participants who received veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A) vs. placebo in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm C).~Statistical significance was determined by a two-sided p-value ≤ 0.2"||0.880|0.503|0.059
71786963|NCT02289690|143072098|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.924|TWO_SIDED|80.0|0.744|1.288|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.288|0.744|0.924
71813133|NCT03720938|143128569|SUPERIORITY|||||||0.005||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.005
71836935|NCT02651428|143179954|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0006|TWO_SIDED|95.0|0.14|0.62||The threshold significance level at the interim and final statistical analyses for the primary efficacy endpoint was 0.0294.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the survival functions for CRBSI between the two treatments. Based on 80% power to detect a 55% reduction in the risk of CRBSI relative to the control treatment, a 1:1 randomization, a 2-sided log-rank test, one interim analysis using the method of Pocock, and an overall alpha of 0.05, it was determined that 56 CRBSIs would be needed. These are the results of the final analysis.||0.62|0.14|0.0006
71836936|NCT02651428|143179955|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4161|TWO_SIDED|95.0|0.9|1.29||The threshold for statistical significance was p \< 0.05.|Log Rank||The numerator for the hazard ratio was the estimated hazard for the Neutrolin treatment arm, and the denominator was the estimated hazard for the Heparin treatment arm.|The null hypothesis was that there was no difference in the time until catheter removal for any reason between the two treatments.||1.29|0.90|0.4161
71836937|NCT03843151|143180038|OTHER||Ratio|192.67|||||TWO_SIDED|90.0|175.19|211.89|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 14.9."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||211.89|175.19|
71670390|NCT01217112|142858077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.556||0.916|TWO_SIDED|90.0|-0.87|0.99|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.99|-0.87|0.916
71836938|NCT03843151|143180039|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 21.7."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
71836939|NCT03843151|143180040|OTHER||Ratio|120.72|||||TWO_SIDED|90.0|105.69|137.87|||||"The effect of itraconazole on BI 1358894 is estimated by the ratio of geometric mean (BI 1358894 + itraconazole / BI 1358894).~geometric coefficient of variation (gCV) \[%\] = 13.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for 'subject' and 'treatment'. The 'subject' effect was considered as random, whereas the 'treatment' effect was considered as fixed.||137.87|105.69|
71836940|NCT03001414|143180041|SUPERIORITY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|16.69||0.42|TWO_SIDED|95.0|-20.08|47.48|||ANOVA|Global test of difference between the arms analyzed as absolute change from baseline.||Due to sample size restriction, the primary analysis plan was modified to analyze change from baseline to each time point using repeated measures of ANOVA.||47.48|-20.08|0.42
71836941|NCT03001414|143180041|SUPERIORITY||Mean Difference (Final Values)|13.7||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Calculation of raw change from baseline in meters using non-parametric Wilcoxon test.||||0.57
71836942|NCT03001414|143180041|SUPERIORITY||Mean Difference (Final Values)|4.55||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Secondary analysis of primary outcome using non-parametric Wilcoxon test of percent change from baseline.||||||0.53
71836943|NCT03001414|143180042|SUPERIORITY|Change from baseline calculated in meters using non-parametric analysis.|Mean Difference (Final Values)|41.97||||0.1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of these arms is in accordance with the statistical analysis plan.||||0.10
71836944|NCT03001414|143180043|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The selected arm for this outcome measure is in accordance with the statistical analysis plan.||||0.50
71836945|NCT03001414|143180044|SUPERIORITY||Mean Difference (Final Values)|22.92||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Comparison of change from baseline in meters at 6 and 12 months.||Selection of the arm for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.88
71836946|NCT03001414|143180045|SUPERIORITY||Mean Difference (Final Values)|0.132||||0.81|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.81
71836947|NCT03001414|143180046|SUPERIORITY||Median Difference (Final Values)|2.06||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.63
71836948|NCT03001414|143180047|SUPERIORITY||Mean Difference (Final Values)|1.39||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
71836949|NCT03001414|143180048|SUPERIORITY||Mean Difference (Final Values)|5.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|This analysis represents the results for the Physical Component score of the questionnaire.||Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||1.0
71836950|NCT03001414|143180048|SUPERIORITY||Median Difference (Final Values)|0.1||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the mental component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.64
71836951|NCT03001414|143180049|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.4|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This analysis represents the difference in score for the physical component of the questionnaire.|Selection of the arms for analysis of this outcome measure is in accordance with the statistical analysis plan.||||0.40
71836952|NCT03001414|143180049|SUPERIORITY||Mean Difference (Final Values)|15.4||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||This analysis represents the change in score for the mental component of the questionnaire.|||0.23
71754218|NCT02977403|143011689|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.036|||||TWO_SIDED|95.0|-0.047|0.119||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.119|-0.047|
71754219|NCT02977403|143011689|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.106|||||TWO_SIDED|95.0|-0.276|0.064||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.064|-0.276|
71758542|NCT02205736|143019222|SUPERIORITY|||||||0.7456||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.7456
71786964|NCT02289690|143072099|SUPERIORITY||Hazard Ratio (HR)|1.432||||0.088|TWO_SIDED|80.0|1.092|1.879|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.879|1.092|0.088
71786965|NCT02289690|143072099|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.083|TWO_SIDED|80.0|1.104|1.931|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of \< 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.931|1.104|0.083
71670391|NCT01217112|142858077|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.583||0.04|TWO_SIDED|90.0|-2.2|-0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||-0.25|-2.20|0.040
71670392|NCT01217112|142858078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|10.838||0.366|TWO_SIDED|90.0|-28.06|8.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||8.27|-28.06|0.366
71670393|NCT01217112|142858078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|10.692||0.844|TWO_SIDED|90.0|-15.81|20.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||20.03|-15.81|0.844
71670394|NCT01217112|142858078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.96|STANDARD_ERROR_OF_MEAN|10.026||0.118|TWO_SIDED|90.0|-32.76|0.84|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.84|-32.76|0.118
71786966|NCT02289690|143072100|SUPERIORITY||Odds Ratio (OR)|1.9||||0.115|TWO_SIDED|80.0|1.1|3.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||3.2|1.1|0.115
71813134|NCT03720938|143128569|SUPERIORITY|||||||0.00603||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.||||0.00603
71813135|NCT03720938|143128570|SUPERIORITY|||||||0.002879||||||The outcome of self-perception for global self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002879
71670395|NCT01217112|142858078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|10.256||0.518|TWO_SIDED|90.0|-23.86|10.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.51|-23.86|0.518
71754220|NCT02977403|143011690|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|-0.017|||||TWO_SIDED|95.0|-0.092|0.057||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.057|-0.092|
71754221|NCT02977403|143011690|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|0.002|||||TWO_SIDED|95.0|-0.15|0.153||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.153|-0.150|
71786967|NCT02289690|143072100|SUPERIORITY||Odds Ratio (OR)|0.8||||0.604|TWO_SIDED|80.0|0.5|1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of \> 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~1. OS (Arm A vs Arm C)~2. PFS (Arms B vs Arm C)~3. OS (Arm B vs Arm C)~4. ORR (Arm A vs Arm C)~5. ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."||1.3|0.5|0.604
71786968|NCT01170754|143072102|NON_INFERIORITY|Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score||||||0.45|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.45
71786969|NCT01170754|143072103|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.13|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.13
71836953|NCT04831216|143180050|OTHER|||||||0.0107||||||The p-value reflects results of analysis of change in HbA1c from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0107
71836954|NCT04831216|143180051|OTHER|||||||0.7927||||||The p-value reflects results of analysis of change in skin carotenoid levels from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.7927
71836955|NCT04831216|143180052|OTHER|||||||0.4651||||||The p-value reflects results of analysis of change in HEI score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.4651
71836956|NCT04831216|143180053|OTHER|||||||0.2439||||||The p-value reflects results of analysis of change in BMI from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2439
71836957|NCT04831216|143180055|OTHER|||||||0.6794||||||The p-value reflects results of analysis of change in DMSES scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.6794
71836958|NCT04831216|143180056|OTHER|||||||0.1043||||||The p-value reflects results of analysis of change in oral health behavior from baseline to post-intervention.|Mixed Models Analysis|Cumulative logit mixed effects model included time, age, household size, gender, race, education, and employment.||Cumulative logit mixed effects model (using PROC GLIMMIX) for repeated measures used all available participant data. This model is specifically designed for ordinal outcomes. Analyses do not include imputed missing values.||||0.1043
71836959|NCT04831216|143180057|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in PAID-5 scale score from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
71836960|NCT04831216|143180059|OTHER|||||||0.5332||||||The p-value reflects results of analysis of change in number of visits to food pantries in the past 30 days from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.5332
71836961|NCT04831216|143180060|OTHER|||||||0.0468||||||The p-value reflects results of analysis of change in ARMS-D scale scores from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0468
71670396|NCT01217112|142858079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.294||0.576|TWO_SIDED|90.0|-0.66|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-0.66|0.576
71670397|NCT01217112|142858079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.283||0.648|TWO_SIDED|90.0|-0.6|0.34|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.34|-0.60|0.648
71670398|NCT01217112|142858079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.269||0.447|TWO_SIDED|90.0|-0.66|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.24|-0.66|0.447
71670399|NCT01217112|142858079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.283||0.273|TWO_SIDED|90.0|-0.79|0.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.16|-0.79|0.273
71670400|NCT01217112|142858080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|1.097||0.615|TWO_SIDED|90.0|-2.4|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-2.40|0.615
71670401|NCT01217112|142858080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.973||0.342|TWO_SIDED|90.0|-0.7|2.57|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.57|-0.70|0.342
71670402|NCT01217112|142858080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.934||0.314|TWO_SIDED|90.0|-2.52|0.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.62|-2.52|0.314
71670403|NCT01217112|142858080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.964||0.889|TWO_SIDED|90.0|-1.48|1.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.75|-1.48|0.889
71670404|NCT01217112|142858081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.89|STANDARD_ERROR_OF_MEAN|168.459||0.764|TWO_SIDED|90.0|-232.02|333.8|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||333.80|-232.02|0.764
71754222|NCT02977403|143011691|SUPERIORITY|Change scores were computed (post-intervention - pre-intervention = delta) for oscillatory power. A linear mixed model was run with change scores as the dependent variable. Between-subject factors were condition, recent LOC-eating (0=absent, 1=present), and a condition by LOC-eating interaction term. Oscillatory power analyses were nested within subject. Models included a random intercept and were adjusted for stimuli pairing type, age, fat mass, height, and race and ethnicity.|beta coefficient|0.07|||||TWO_SIDED|95.0|-0.019|0.159||Effect sizes and 95% CIs, rather than statistical significance, were used. Cohen's d was interpreted as minimal to no effect (\<.02) small effect (0.2-0.49) medium effect (0.5-0.79) large effect (0.8).|||To examine changes in oscillatory power, change scores were computed (post-pre=delta). Positive scores represent an increase from pre- to post- intervention. Negative scores represent a decrease from pre- to post- intervention.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||0.159|-0.019|
71670405|NCT01217112|142858081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|156.72||0.654|TWO_SIDED|90.0|-333.96|192.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||192.44|-333.96|0.654
71670406|NCT01217112|142858081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-111.5|STANDARD_ERROR_OF_MEAN|146.276||0.45|TWO_SIDED|90.0|-357.17|134.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||134.16|-357.17|0.450
71754223|NCT02977403|143011691|SUPERIORITY|See Statistical Analysis 1 for details. No p-values supplied, only confidence intervals and Cohen's d|beta coefficient|-0.095|||||TWO_SIDED|95.0|-0.26|0.07||||||Interaction of Loss of Control Eating with attention bias. See Statistical Analysis 1 for details.||0.070|-0.260|
71754224|NCT02977403|143011692|SUPERIORITY||beta coefficient|-0.8707|STANDARD_ERROR_OF_MEAN|0.766||0.256|TWO_SIDED||||||Generalized estimation equations||Reported variable is a condition by time (pre or post-intervention) interaction term. The model included a Poisson distribution, log link function, exchangeable covariance matrix and was adjusted for age, fat mass, height, and race and ethnicity.|Sample size estimation was based on the power analysis for the first hypothesis (examine changes in oscillatory power following completion of the smartphone program). Assuming 35% attrition, 80 girls, 40 with LOC-eating and 40 without LOC-eating, were estimated to provide \>80% power to detect medium to large effects.||||0.256
71836962|NCT04831216|143180063|OTHER||||||<|0.0001||||||The p-value reflects results of analysis of change in days per week following general healthful diet from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||<0.0001
71754225|NCT03589859|143011703|OTHER|This was a physiology study, not a treatment trial. The test was for a change in VOR gain.|||||<|0.001|||||||Mixed Models Analysis|||A linear mixed effects model was used to compare pre- and post-training VOR gains||||<0.001
71670407|NCT01217112|142858081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|97.42|STANDARD_ERROR_OF_MEAN|149.124||0.517|TWO_SIDED|90.0|-153.02|347.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||347.86|-153.02|0.517
71670408|NCT01217112|142858082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.33|STANDARD_ERROR_OF_MEAN|40.94||0.84|TWO_SIDED|90.0|-60.28|76.94|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||76.94|-60.28|0.840
71754226|NCT04966013|143011706|SUPERIORITY||Hazard Ratio (HR)|1.005||||0.9784|TWO_SIDED|95.0|0.717|1.408|||Regression, Cox|||Log Rank Test and Cox PH Regression analyses were performed unstratified||1.408|0.717|0.9784
71754227|NCT04966013|143011707|SUPERIORITY||Hazard Ratio (HR)|1.388||||0.1512|TWO_SIDED|95.0|0.887|2.172||Log Rank Test and Cox PH Regression analyses were performed unstratified|Regression, Cox|||||2.172|0.887|0.1512
71754228|NCT05010707|143011718|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||Time x treatment (month 0, and 1 month)||||0.005
71754229|NCT05010707|143011718|SUPERIORITY||Mean Difference (Final Values)|-225.3||||0.02|TWO_SIDED|95.0|-421.71|-28.79|||Mixed Models Analysis|||||-28.79|-421.71|0.02
71786970|NCT01170754|143072104|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.31|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.31
71786971|NCT01170754|143072105|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.87|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.87
71786972|NCT01170754|143072106|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.25|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.25
71786973|NCT01170754|143072107|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.47|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.47
71786974|NCT01170754|143072108|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.34|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.34
71786975|NCT01170754|143072109|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.18|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.18
71786976|NCT01170754|143072110|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.75|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.75
71754230|NCT05010707|143011718|SUPERIORITY||Mean Difference (Final Values)|-250.6||||0.009|TWO_SIDED|95.0|-447.1|-54.19|||Mixed Models Analysis|||||-54.19|-447.10|0.009
71754231|NCT05010707|143011719|SUPERIORITY|||||||0.951|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.951
71754232|NCT05010707|143011719|SUPERIORITY||Mean Difference (Final Values)|-1.6||||1|TWO_SIDED|95.0|-29.6|26.4|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||26.4|-29.6|1
71754233|NCT05010707|143011719|SUPERIORITY||Mean Difference (Final Values)|-7.1||||1|TWO_SIDED|95.0|-35.1|20.8|||Mixed Models Analysis||The mean difference is computed using the model based estimates rather than from the raw data.|||20.8|-35.1|1
71754234|NCT05010707|143011720|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||Time x treatment (month 0 and month 1)||||0.004
71754235|NCT05010707|143011720|SUPERIORITY||Mean Difference (Final Values)|-280.4||||0.005|TWO_SIDED|95.0|-487.3|-73.5|||Mixed Models Analysis|||||-73.5|-487.3|0.005
71754236|NCT05010707|143011720|SUPERIORITY||Mean Difference (Final Values)|-204.1||||0.054|TWO_SIDED|95.0|-411.1|2.8|||Mixed Models Analysis|||||2.8|-411.1|0.054
71754237|NCT03518086|143011721|SUPERIORITY||Risk Difference (RD)|11.1||||6e-05|TWO_SIDED|99.875|3.2|19.1|||Cochran-Mantel-Haenszel|||||19.1|3.2|0.00006
71754238|NCT03518086|143011722|SUPERIORITY||Risk Difference (RD)|21.4|||<|1e-05|TWO_SIDED|99.875|10.8|32.0|||Cochran-Mantel-Haenszel|||||32.0|10.8|<0.00001
71754239|NCT03518086|143011723|SUPERIORITY||Risk Difference (RD)|15.4|||<|1e-05|TWO_SIDED|99.875|6.3|24.5|||Cochran-Mantel-Haenszel|||||24.5|6.3|<0.00001
71754240|NCT03518086|143011724|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|99.875|11.4|23.6|||Cochran-Mantel-Haenszel|||||23.6|11.4|<0.001
71754241|NCT03518086|143011725|SUPERIORITY||Risk Difference (RD)|20.2|||<|0.001|TWO_SIDED|95.0|13.8|26.6|||Cochran-Mantel-Haenszel|||||26.6|13.8|<0.001
71754242|NCT03518086|143011726|SUPERIORITY||Risk Difference (RD)|13.7|||<|0.001|TWO_SIDED|95.0|8.6|18.7|||Cochran-Mantel-Haenszel|||||18.7|8.6|<0.001
71786977|NCT01170754|143072111|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.92|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.92
71786978|NCT01170754|143072112|EQUIVALENCE|Equivalence between the two groups was defined as a p-value = or \>.05.||||||0.6|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided|||||||.60
71786979|NCT01170754|143072113|NON_INFERIORITY|Inferiority between groups was defined as a difference of 10% in the overall BBPS score.||||||0.98|TWO_SIDED|95.0||||p\<.05 was defined as the a priori threshold for statistical significance.|t-test, 2 sided|||||||.98
71786980|NCT02254486|143072114|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|0.14||||0.528|ONE_SIDED|97.5|-8.15|||P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-8.15|0.528
71670409|NCT01217112|142858082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|39.521||0.834|TWO_SIDED|90.0|-57.92|74.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||74.55|-57.92|0.834
71670410|NCT01217112|142858082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.62|STANDARD_ERROR_OF_MEAN|39.044||0.767|TWO_SIDED|90.0|-77.06|53.81|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||53.81|-77.06|0.767
71670411|NCT01217112|142858082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.51|STANDARD_ERROR_OF_MEAN|39.68||0.289|TWO_SIDED|90.0|-23.99|109.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||109.01|-23.99|0.289
71786981|NCT02254486|143072115|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|6.58||||0.059|ONE_SIDED|97.5|-1.69|||P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value \<0.025; the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-1.69|0.059
71786982|NCT02254486|143072116|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-3.01||||0.863|TWO_SIDED|95.0|-11.36|5.28||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||5.28|-11.36|0.863
71786983|NCT02254486|143072117|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.66||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.660
71786984|NCT02254486|143072118|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.953||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||||0.953
71786985|NCT02254486|143072119|NON_INFERIORITY_OR_EQUIVALENCE|Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.||||||0.781|||||||Fisher Exact|||If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||||0.781
71836963|NCT04831216|143180064|OTHER|||||||0.0649||||||The p-value reflects results of analysis of change in days per week following specific diet recommendations from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0649
71845512|NCT06072170|143205462|OTHER|Proportionality analysis was done using a power model.|Slope|1.025|||||TWO_SIDED|90.0|0.859|1.191||||||Statistical Analysis for Dose-Proportionality of Speciociliatine Dose Adjusted Pharmacokinetic Parameters (Pharmacokinetic Population)||1.191|0.859|
71845513|NCT06072170|143205466|SUPERIORITY||Least-Square Mean|18.5|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|6.16|30.78||||||||30.78|6.16|
71670412|NCT01217112|142858083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.106||0.569|TWO_SIDED|90.0|-0.24|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.12|-0.24|0.569
71891934|NCT04971226|143305421|SUPERIORITY||Risk Difference (RD)|29.55|||<|0.001|TWO_SIDED|95.0|16.91|42.18|||Mantel Haenszel||The Estimate Value is a percentage.||The Confidence Interval are percentages.|42.18|16.91|<0.001
71891935|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.36|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-21.96|15.24|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 1||15.24|-21.96|
71891936|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-30.01|6.4|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg versus Placebo Day 1||6.40|-30.01|
71754243|NCT03518086|143011727|SUPERIORITY||Risk Difference (RD)|19.5|||<|1e-05|TWO_SIDED|95.0|13.2|25.8|||Cochran-Mantel-Haenszel|||||25.8|13.2|<0.00001
71891937|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-25.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-42.99|-8.32|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 1||-8.32|-42.99|
71891938|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|14.74|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-5.06|34.53|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 28||34.53|-5.06|
71754244|NCT03518086|143011728|SUPERIORITY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.159|<|1e-05|TWO_SIDED|99.875|-1.47|-0.44|||Mixed Models Analysis||The confidence interval of 99.875 % was chosen to match the significance level.|||-0.44|-1.47|<0.00001
71754245|NCT03518086|143011729|SUPERIORITY||Mean Difference (Net)|13.21|STANDARD_ERROR_OF_MEAN|2.005|<|0.001|TWO_SIDED|95.0|9.28|17.15|||ANCOVA|||||17.15|9.28|<0.001
71754246|NCT03518086|143011730|SUPERIORITY||Mean Difference (Net)|-935.6|STANDARD_ERROR_OF_MEAN|218.09|<|0.001|TWO_SIDED|95.0|-1363.64|-507.55|||Mixed Models Analysis|||||-507.55|-1363.64|<0.001
71754247|NCT00626106|143011755|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.542|TWO_SIDED|95.0|-0.11|0.07|||ANCOVA|||||0.07|-0.11|0.542
71754248|NCT02994108|143011774|SUPERIORITY||Chi-Square|0.415||||0.601|TWO_SIDED||||||Chi-squared|||||||.601
71754249|NCT02994108|143011775|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.249|TWO_SIDED||||||t-test, 2 sided|||||||.249
71754250|NCT02994108|143011776|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.675|TWO_SIDED||||||t-test, 2 sided|||||||.675
71754251|NCT02994108|143011777|SUPERIORITY||Odds Ratio (OR)|3.43||||0.025|TWO_SIDED|95.0|1.17|10.08|||Regression, Logistic|||||10.08|1.17|.025
71754252|NCT02994108|143011778|SUPERIORITY||Odds Ratio (OR)|1.14||||0.923|TWO_SIDED|95.0|0.08|16.95|||Regression, Logistic|||||16.95|0.08|.923
71754253|NCT02994108|143011779|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.174|TWO_SIDED||||||t-test, 2 sided|||||||.174
71754254|NCT02994108|143011780|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||.002
71754255|NCT02994108|143011781|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.964|TWO_SIDED||||||t-test, 2 sided|||||||.964
71754256|NCT02994108|143011782|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||.053
71754257|NCT02994108|143011783|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.183|TWO_SIDED||||||t-test, 2 sided|||||||.183
71754258|NCT02994108|143011784|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.064|TWO_SIDED||||||t-test, 2 sided|||||||.064
71754259|NCT02994108|143011785|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.147|TWO_SIDED||||||t-test, 2 sided|||||||.147
71754260|NCT02994108|143011786|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.096|TWO_SIDED||||||t-test, 2 sided|||||||.096
71754261|NCT02994108|143011787|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.013|TWO_SIDED||||||t-test, 2 sided|||||||.013
71754262|NCT00781768|143011788|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED||||||Chi-squared|||The null hypothesis is that there will be a higher proportion of complete responders among those subjects receiving the combination therapy.||||<.001
71754263|NCT04567628|143011791|OTHER||||||=|0.003|||||||Spearman's Rank Correlation|||||||=0.003
71754264|NCT04567628|143011792|OTHER||||||=|0.25||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||=0.25
71754265|NCT04567628|143011795|OTHER||||||<|0.001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.001
71754266|NCT04567628|143011797|OTHER||||||<|0.0001||||||A two-sided p-value of \<0.05 was considered statistically significant.|Log Rank|||||||<0.0001
71754267|NCT02458313|143011803|SUPERIORITY|DMXB-A vs. Placebo groups compared at baseline||||||0.647|||||||t-test, 2 sided|||||||0.647
71754268|NCT02458313|143011803|SUPERIORITY|||||||0.679|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.679
71754269|NCT02458313|143011804|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared at baseline||||0.951
71754270|NCT02458313|143011804|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||DMXB-A vs. Placebo groups compared post-intervention||||0.884
71754271|NCT01097668|143011860|SUPERIORITY_OR_OTHER||||||<|0.001|||||||negative binomial model|||Comparison of the baseline 'ITT population' MRI data with week 16 data.||||<0.001
71754272|NCT01097668|143011860|SUPERIORITY_OR_OTHER|||||||0.03|||||||negative binomial model|||Comparison of the baseline 'MRI population' data with data from week 16.||||0.030
71758543|NCT02205736|143019222|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 10 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71754273|NCT00385671|143011885|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.49||||0.076|TWO_SIDED|95.0|-0.05|1.04||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin \& duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||1.04|-0.05|0.076
71754274|NCT00385671|143011886|NON_INFERIORITY_OR_EQUIVALENCE|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.23||||0.417|TWO_SIDED|95.0|-0.32|0.78||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine \& duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.||0.78|-0.32|0.417
71754275|NCT00385671|143011887|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
71754276|NCT00385671|143011887|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.520
71754277|NCT00385671|143011887|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||||0.463
71754278|NCT00385671|143011888|SUPERIORITY_OR_OTHER|||||||0.389||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.389
71754279|NCT00385671|143011888|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.126
71754280|NCT00385671|143011888|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.||||0.489
71786986|NCT00356369|143072178|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (\>) -15%.|Difference in % for rSBA-MenA antibodies|13.0|||||TWO_SIDED|95.0|3.52|23.5||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||23.5|3.52|
71845514|NCT06072170|143205469|SUPERIORITY||Least-Squared Mean|45.9|STANDARD_ERROR_OF_MEAN|7.74|<|0.001|TWO_SIDED|95.0|30.2|61.67|||ANOVA|||Statistical Analysis for High Visual Analog Scale (Emax)||61.67|30.20|<0.001
71670413|NCT01217112|142858083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.101||0.984|TWO_SIDED|90.0|-0.17|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.17|-0.17|0.984
71754281|NCT00385671|143011889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.602|TWO_SIDED|95.0|-0.2|0.35||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.35|-0.20|0.602
71754282|NCT00385671|143011889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.469|TWO_SIDED|95.0|-0.17|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.37|-0.17|0.469
71754283|NCT00385671|143011889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.841|TWO_SIDED|95.0|-0.24|0.3||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.||0.30|-0.24|0.841
71754284|NCT00385671|143011890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.276|TWO_SIDED|95.0|-0.16|0.55||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.55|-0.16|0.276
71754285|NCT00385671|143011890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.929|TWO_SIDED|95.0|-0.33|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.||0.37|-0.33|0.929
71754286|NCT00385671|143011890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.313|TWO_SIDED|95.0|-0.53|0.17||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.||0.17|-0.53|0.313
71754287|NCT00385671|143011891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.078|TWO_SIDED|95.0|-0.06|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.04|-0.06|0.078
71754288|NCT00385671|143011891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.025|TWO_SIDED|95.0|0.08|1.2||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||1.20|0.08|0.025
71754289|NCT00385671|143011891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.||0.70|-0.41|0.602
71754290|NCT00385671|143011892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.353|TWO_SIDED|95.0|-0.34|0.94||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||0.94|-0.34|0.353
71754291|NCT00385671|143011892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.039|TWO_SIDED|95.0|0.03|1.34||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.||1.34|0.03|0.039
71754292|NCT00385671|143011892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.244|TWO_SIDED|95.0|-0.27|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.||1.04|-0.27|0.244
71670414|NCT01217112|142858083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.098||0.176|TWO_SIDED|90.0|-0.3|0.03|||ANCOVA|||v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.30|0.176
71670415|NCT01217112|142858083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.099||0.895|TWO_SIDED|90.0|-0.15|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.18|-0.15|0.895
71670416|NCT01217112|142858084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.745||0.871|TWO_SIDED|90.0|-1.13|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.13|0.871
71670417|NCT01217112|142858084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.721||0.826|TWO_SIDED|90.0|-1.05|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-1.05|0.826
71754293|NCT00385671|143011893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.298|TWO_SIDED|95.0|-0.25|0.8||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.80|-0.25|0.298
71670418|NCT01217112|142858084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.703||0.693|TWO_SIDED|90.0|-1.46|0.9|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.90|-1.46|0.693
71670419|NCT01217112|142858084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.722||0.536|TWO_SIDED|90.0|-0.76|1.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.66|-0.76|0.536
71670420|NCT01217112|142858085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|8.633||0.878|TWO_SIDED|90.0|-15.8|13.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||13.13|-15.80|0.878
71754294|NCT00385671|143011893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.304|TWO_SIDED|95.0|-0.25|0.81||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.||0.81|-0.25|0.304
71786987|NCT00356369|143072178|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenC antibodies|4.18|||||TWO_SIDED|95.0|-1.03|11.36||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.36|-1.03|
71786988|NCT00356369|143072178|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in%for rSBA-MenW-135 antibody|4.58|||||TWO_SIDED|95.0|-0.07|11.49||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||11.49|-0.07|
71786989|NCT00356369|143072178|NON_INFERIORITY|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenY antibodies|8.05|||||TWO_SIDED|95.0|1.72|16.17||||||To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.||16.17|1.72|
71786990|NCT00356369|143072179|NON_INFERIORITY|Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.|Difference in % Grade 3 general symptoms|1.34|||||TWO_SIDED|95.0|-1.64|3.09||||||To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.||3.09|-1.64|
71786991|NCT03530098|143072227|SUPERIORITY||Odds Ratio (OR)|-0.59||||0.04|TWO_SIDED|95.0|-1.14|-0.04|||t-test, 2 sided|||||-0.04|-1.14|0.04
71786992|NCT03530098|143072228|OTHER|||||||0.001|||||||Wilcoxon rank-sum test|||||||0.001
71786993|NCT02730455|143072297|SUPERIORITY||Odds Ratio (OR)|0.64||||0.086|TWO_SIDED|95.0|0.38|1.07|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline National Institute of Health Stroke Scale (NIHSS) category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tissue plasminogen activator (tPA) use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, United States of America \[USA\]) as covariates and unstructured working correlation structure||1.07|0.38|0.086
71786994|NCT02730455|143072297|SUPERIORITY||Odds Ratio (OR)|0.57||||0.031|TWO_SIDED|95.0|0.34|0.95|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||0.95|0.34|0.031
71754295|NCT00385671|143011893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.989|TWO_SIDED|95.0|-0.53|0.54||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.||0.54|-0.53|0.989
71754296|NCT00385671|143011894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.145|TWO_SIDED|95.0|-0.14|0.97||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||0.97|-0.14|0.145
71754297|NCT00385671|143011894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.112|TWO_SIDED|95.0|-0.11|1.03||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.||1.03|-0.11|0.112
71754298|NCT00385671|143011894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.865|TWO_SIDED|95.0|-0.52|0.62||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.||0.62|-0.52|0.865
71754299|NCT00385671|143011895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.263|TWO_SIDED|95.0|-0.26|0.95||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||0.95|-0.26|0.263
71754300|NCT00385671|143011895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.007|TWO_SIDED|95.0|0.24|1.49||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.49|0.24|0.007
71754301|NCT00385671|143011895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.102|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.||1.13|-0.10|0.102
71754302|NCT00385671|143011896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.922|TWO_SIDED|95.0|-0.61|0.55||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.55|-0.61|0.922
71786995|NCT02730455|143072298|SUPERIORITY||Odds Ratio (OR)|0.67||||0.222|TWO_SIDED|95.0|0.35|1.28|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.28|0.35|0.222
71786996|NCT02730455|143072298|SUPERIORITY||Odds Ratio (OR)|0.54||||0.073|TWO_SIDED|95.0|0.28|1.06|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure||1.06|0.28|0.073
71786997|NCT02730455|143072299|SUPERIORITY||Odds Ratio (OR)|0.56||||0.085|TWO_SIDED|95.0|0.29|1.08|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.08|0.29|0.085
71786998|NCT02730455|143072299|SUPERIORITY||Odds Ratio (OR)|0.54||||0.067|TWO_SIDED|95.0|0.28|1.04|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (\<60, 60-69, 70-80), tPA use (yes/no), treatment window (\<=9, \>9 and \<=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.||1.04|0.28|0.067
71786999|NCT02730455|143072300|SUPERIORITY||Adjusted Mean Difference|-7.7||||0.106|TWO_SIDED|95.0|-16.97|1.64|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.64|-16.97|0.106
71754303|NCT00385671|143011896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.99||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||0.99|-0.20|0.195
71754304|NCT00385671|143011896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.162|TWO_SIDED|95.0|-0.17|1.02||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.||1.02|-0.17|0.162
71754305|NCT00385671|143011897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.541|TWO_SIDED|95.0|-0.46|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||0.87|-0.46|0.541
71670421|NCT01217112|142858085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|8.377||0.919|TWO_SIDED|90.0|-13.18|14.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||14.89|-13.18|0.919
71670422|NCT01217112|142858085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.72|STANDARD_ERROR_OF_MEAN|7.989||0.557|TWO_SIDED|90.0|-8.67|18.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||18.11|-8.67|0.557
71670423|NCT01217112|142858085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|8.328||0.275|TWO_SIDED|90.0|-4.76|23.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||23.16|-4.76|0.275
71670424|NCT01217112|142858086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|16.445||0.528|TWO_SIDED|90.0|-17.12|38.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||38.01|-17.12|0.528
71754306|NCT00385671|143011897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.051|TWO_SIDED|95.0|0.0|1.36||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.36|-0.00|0.051
71754307|NCT00385671|143011897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.173|TWO_SIDED|95.0|-0.21|1.15||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.||1.15|-0.21|0.173
71754308|NCT00385671|143011898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.451|TWO_SIDED|95.0|-0.4|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.||0.90|-0.40|0.451
71754309|NCT00385671|143011898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.485|TWO_SIDED|95.0|-0.43|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.90|-0.43|0.485
71754310|NCT00385671|143011898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.68|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.||0.65|-0.68|0.969
71787000|NCT02730455|143072300|SUPERIORITY||Adjusted Mean Difference|-6.1||||0.202|TWO_SIDED|95.0|-15.43|3.27|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.27|-15.43|0.202
71845515|NCT02949297|143205480|OTHER|One-sided Clopper-Pearson 95% confidence interval|Clopper-Pearson|80.0|||||ONE_SIDED|95.0||95.0|||||One-sided Clopper-Pearson 95% confidence interval|||95||
71670425|NCT01217112|142858086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|15.825||0.99|TWO_SIDED|90.0|-26.32|26.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||26.72|-26.32|0.990
71754311|NCT00385671|143011899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.479|TWO_SIDED|95.0|-0.36|0.76||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.||0.76|-0.36|0.479
71754312|NCT00385671|143011899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.301|TWO_SIDED|95.0|-0.27|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.87|-0.27|0.301
71754313|NCT00385671|143011899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.47|0.67||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.||0.67|-0.47|0.731
71754314|NCT00385671|143011900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.528|TWO_SIDED|95.0|-0.45|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.87|-0.45|0.528
71754315|NCT00385671|143011900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.626|TWO_SIDED|95.0|-0.84|0.51||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.51|-0.84|0.626
71754316|NCT00385671|143011900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.27|TWO_SIDED|95.0|-1.06|0.3||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.||0.30|-1.06|0.270
71754317|NCT00385671|143011901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.098|TWO_SIDED|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||1.13|-0.10|0.098
71787001|NCT02730455|143072301|SUPERIORITY||Adjusted Mean Difference|-0.3||||0.78|TWO_SIDED|95.0|-2.64|1.99|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.99|-2.64|0.780
71787002|NCT02730455|143072301|SUPERIORITY||Adjusted Mean Difference|-0.6||||0.622|TWO_SIDED|95.0|-2.89|1.73|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.73|-2.89|0.622
71787003|NCT02730455|143072302|SUPERIORITY||Adjusted Mean Difference|1.2||||0.315|TWO_SIDED|95.0|-1.1|3.4|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||3.40|-1.10|0.315
71787004|NCT02730455|143072302|SUPERIORITY||Adjusted Mean Difference|-0.7||||0.542|TWO_SIDED|95.0|-2.96|1.56|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (\<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.||1.56|-2.96|0.542
71670426|NCT01217112|142858086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|15.369||0.776|TWO_SIDED|90.0|-21.37|30.15|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||30.15|-21.37|0.776
71787005|NCT02730455|143072305|SUPERIORITY|||||||0.028|||||||Cochran-Armitage trend test|||"mRS: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome.~Dose levels are log transformed."||||0.028
71787006|NCT02730455|143072305|SUPERIORITY|||||||0.049|||||||Cochran-Armitage trend test|||BI: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome. Dose levels are log transformed.||||0.049
71787007|NCT02480439|143072313|SUPERIORITY_OR_OTHER||Point Estimate|0.966|||||TWO_SIDED|90.0|0.8747|1.0668|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0668|0.8747|
71787008|NCT02480439|143072313|SUPERIORITY_OR_OTHER||Point Estimate|0.9223|||||TWO_SIDED|90.0|0.8352|1.0185|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0185|0.8352|
71787009|NCT02480439|143072314|SUPERIORITY_OR_OTHER||Point Estimate|0.9998|||||TWO_SIDED|90.0|0.954|1.0477|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0477|0.9540|
71787010|NCT02480439|143072314|SUPERIORITY_OR_OTHER||Point Estimate|1.0149|||||TWO_SIDED|90.0|0.9685|1.0636|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0636|0.9685|
71787011|NCT02480439|143072315|SUPERIORITY_OR_OTHER||Point Estimate|0.9992|||||TWO_SIDED|90.0|0.9541|1.0464|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0464|0.9541|
71787012|NCT02480439|143072315|SUPERIORITY_OR_OTHER||Point Estimate|1.0134|||||TWO_SIDED|90.0|0.9676|1.0612|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.|||1.0612|0.9676|
71787013|NCT02268084|143072319|SUPERIORITY|||||||0.007|||||||ANOVA|||Null hypothesis is that the active treatment group does not differ from the sham group in changes in the PCL-M total scores.||||.007
71787014|NCT02268084|143072320|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||.326
71787015|NCT01683383|143072343|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Adjusted Wald estimation|||||||<0.001
71787016|NCT01683383|143072344|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71787017|NCT01683383|143072346|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71787018|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.06|||||TWO_SIDED|95.0|2.55|6.46|||||Ratio of GMTs at Day 22|||6.46|2.55|
71787019|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.25|||||TWO_SIDED|95.0|1.42|3.56|||||Ratio of GMTs at Day 22|||3.56|1.42|
71787020|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.49|||||TWO_SIDED|95.0|2.8|7.19|||||Ratio of GMTs at Day 22|||7.19|2.8|
71787021|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.49|||||TWO_SIDED|95.0|1.56|3.96|||||Ratio of GMTs at Day 22|||3.96|1.56|
71787022|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|8.01|||||TWO_SIDED|95.0|5.52|12.0|||||Ratio of GMTs at Day 43|||12|5.52|
71787023|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.25|||||TWO_SIDED|95.0|2.94|6.15|||||Ratio of GMTs at Day 43|||6.15|2.94|
71787024|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|7.81|||||TWO_SIDED|95.0|5.36|11.0|||||Ratio of GMTs at Day 43|||11|5.36|
71787025|NCT00996307|143072353|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratios of GMTs|4.15|||||TWO_SIDED|95.0|2.86|6.02|||||Ratio of GMTs at Day 43|||6.02|2.86|
71787026|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|3.66|||||TWO_SIDED|95.0|2.37|5.65||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22||5.65|2.37|
71787027|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.21|||||TWO_SIDED|95.0|1.43|3.4||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||3.4|1.43|
71787028|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.42|||||TWO_SIDED|95.0|2.85|6.86||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||6.86|2.85|
71787029|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|2.67|||||TWO_SIDED|95.0|1.72|4.13||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.||4.13|1.72|
71787030|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.82|||||TWO_SIDED|95.0|5.54|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.54|
71787031|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.55|||||TWO_SIDED|95.0|3.23|6.42||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines||6.42|3.23|
71670427|NCT01217112|142858086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|44.51|STANDARD_ERROR_OF_MEAN|15.834||0.007|TWO_SIDED|90.0|17.98|71.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||71.05|17.98|0.007
71670428|NCT01217112|142858087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.536||0.717|TWO_SIDED|90.0|-0.7|1.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.09|-0.70|0.717
71836964|NCT04831216|143180065|OTHER|||||||0.0049||||||The p-value reflects results of analysis of change in days per week engaging in exercise from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0049
71670429|NCT01217112|142858087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.531||0.218|TWO_SIDED|90.0|-0.23|1.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.55|-0.23|0.218
71670430|NCT01217112|142858087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.514||0.378|TWO_SIDED|90.0|-0.4|1.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.32|-0.40|0.378
71836965|NCT04831216|143180066|OTHER|||||||0.0086||||||The p-value reflects results of analysis of change in days per week conducted blood glucose testing from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0086
71836966|NCT04831216|143180067|OTHER|||||||0.0243||||||The p-value reflects results of analysis of change in days per week conducting food checks from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.0243
71836967|NCT04831216|143180068|OTHER|||||||0.2861||||||The p-value reflects results of analysis of change in smoking status (yes/no) from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.2861
71836968|NCT04831216|143180069|OTHER|||||||0.9933||||||The p-value reflects results of analysis of change in days per week adhering to prescribed medications from baseline to post-intervention.|Mixed Models Analysis|Linear mixed effects regression model included time, age, household size, gender, race, education, and employment.||Linear mixed effects regression model for repeated measures used all available participant data. Analyses do not include imputed missing values.||||0.9933
71836969|NCT03930342|143180086|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.83|1.07|||Regression, Logistic|Used marginal standardization to estimate relative risk from logistic regression||Results here reflect analysis of the relative risk for AEP that is a combination of risk from baseline to the 3 month timepoint and risk between the 3 month timepoint and 6 month timepoint. This reflects changes in AEP risk across the course of exposure to the intervention (baseline to 3 month) and enduring change post-exposure (3 months to 6 months)||1.07|0.83|
71836970|NCT01804816|143180141|EQUIVALENCE|a=0.05||||||0.063|||||||t-test, 2 sided|||||||0.063
71836971|NCT01804816|143180142|EQUIVALENCE|a = 0.05||||||0.005|||||||t-test, 2 sided|||Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.||||0.005
71836972|NCT01804816|143180142|EQUIVALENCE|a=0.05||||||0.002|||||||t-test, 2 sided|||||||0.002
71670431|NCT01217112|142858087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.532||0.361|TWO_SIDED|90.0|-0.4|1.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.38|-0.40|0.361
71836973|NCT01804816|143180142|EQUIVALENCE|a=0.05||||||0.441|||||||t-test, 2 sided|||||||0.441
71836974|NCT01804816|143180143|EQUIVALENCE|a=0.05||||||0.729|||||||t-test, 2 sided|||||||0.729
71836975|NCT03400059|143180145|SUPERIORITY||Mean Difference (Final Values)|-2.23||||0.0132|TWO_SIDED|95.0|-4.11|-0.49||"analysis of covariance (ANCOVA) model containing terms for treatment, baseline value and medication overuse.~Group-sequential analysis using updated boundaries from interim analysis"|ANCOVA|||||-0.49|-4.11|0.0132
71836976|NCT03400059|143180146|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0014|TWO_SIDED|95.0|-4.32|-1.04|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-1.04|-4.32|0.0014
71836977|NCT03400059|143180147|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.0048|TWO_SIDED|95.0|-4.06|-0.73|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse||||-0.73|-4.06|0.0048
71836978|NCT03400059|143180148|SUPERIORITY||Mean Difference (Final Values)|-2.87||||0.0008|TWO_SIDED|95.0|-4.54|-1.2|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-1.20|-4.54|0.0008
71836979|NCT03400059|143180149|SUPERIORITY||Mean Difference (Final Values)|-1.53||||0.0598|TWO_SIDED|95.0|-3.12|0.06|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||0.06|-3.12|0.0598
71836980|NCT03400059|143180150|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.031|TWO_SIDED|95.0|-3.63|-0.17|||ANCOVA|ANCOVA model containing terms for treatment, baseline value and medication overuse.||||-0.17|-3.63|0.0310
71754318|NCT00385671|143011901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.383|TWO_SIDED|95.0|-0.35|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.90|-0.35|0.383
71787032|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|7.52|||||TWO_SIDED|95.0|5.3|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||11|5.3|
71670432|NCT01217112|142858088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.417|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.417
71670433|NCT01217112|142858088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.34|TWO_SIDED|90.0|-0.01|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.04|-0.01|0.340
71670434|NCT01217112|142858088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.013||0.915|TWO_SIDED|90.0|-0.02|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.02|-0.02|0.915
71670435|NCT01217112|142858088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.013||0.465|TWO_SIDED|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.01|0.465
71787033|NCT00996307|143072353|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.37|||||TWO_SIDED|95.0|3.09|6.19||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.||6.19|3.09|
71670436|NCT01217112|142858089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|1.616||0.646|TWO_SIDED|90.0|-1.96|3.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.45|-1.96|0.646
71670437|NCT01217112|142858089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.99|STANDARD_ERROR_OF_MEAN|1.598||0.219|TWO_SIDED|90.0|-0.69|4.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.66|-0.69|0.219
71670438|NCT01217112|142858089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.61|STANDARD_ERROR_OF_MEAN|1.563||0.307|TWO_SIDED|90.0|-1.0|4.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.23|-1.00|0.307
71754319|NCT00385671|143011901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.452|TWO_SIDED|95.0|-0.86|0.39||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.||0.39|-0.86|0.452
71754320|NCT00385671|143011902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.309|TWO_SIDED|95.0|-0.26|0.82||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.82|-0.26|0.309
71754321|NCT00385671|143011902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38||||0.174|TWO_SIDED|95.0|-0.17|0.93||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.93|-0.17|0.174
71754322|NCT00385671|143011902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.717|TWO_SIDED|95.0|-0.45|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.||0.65|-0.45|0.717
71787034|NCT00536198|143072370|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||Group comparison||||0.21
71787035|NCT00536198|143072370|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71787036|NCT00536198|143072370|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.06
71787037|NCT00536198|143072370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.88|STANDARD_ERROR_OF_MEAN|0.95||0.049|TWO_SIDED|95.0|0.01|3.75|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||3.75|0.01|0.049
71787038|NCT00536198|143072371|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||ANOVA|||Group comparison||||0.54
71787039|NCT00536198|143072371|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71670439|NCT01217112|142858089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.52|STANDARD_ERROR_OF_MEAN|1.612||0.348|TWO_SIDED|90.0|-1.17|4.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.22|-1.17|0.348
71670440|NCT01217112|142858090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.299||0.187|TWO_SIDED|90.0|-0.44|3.91|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.91|-0.44|0.187
71670441|NCT01217112|142858090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|1.28||0.578|TWO_SIDED|90.0|-1.43|2.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.86|-1.43|0.578
71670442|NCT01217112|142858090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|1.249||0.368|TWO_SIDED|90.0|-0.96|3.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.22|-0.96|0.368
71670443|NCT01217112|142858090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|1.304||0.696|TWO_SIDED|90.0|-1.67|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.67|0.696
71670444|NCT01217112|142858091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|1.32||0.327|TWO_SIDED|90.0|-0.9|3.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.51|-0.90|0.327
71670445|NCT01217112|142858091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|1.303||0.851|TWO_SIDED|90.0|-1.93|2.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.43|-1.93|0.851
71670446|NCT01217112|142858091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.281||0.672|TWO_SIDED|90.0|-1.6|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.69|-1.60|0.672
71670447|NCT01217112|142858091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.327||0.978|TWO_SIDED|90.0|-2.26|2.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.18|-2.26|0.978
71787040|NCT00536198|143072371|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison of rates of change||||0.02
71787041|NCT00536198|143072371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.14|STANDARD_ERROR_OF_MEAN|1.62||0.0015|TWO_SIDED|95.0|1.97|8.31|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||8.31|1.97|0.0015
71670448|NCT01217112|142858092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.512||0.857|TWO_SIDED|90.0|-0.95|0.76|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.76|-0.95|0.857
71670449|NCT01217112|142858092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.549||0.543|TWO_SIDED|90.0|-0.58|1.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.26|-0.58|0.543
71670450|NCT01217112|142858092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.495||0.859|TWO_SIDED|90.0|-0.74|0.92|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.92|-0.74|0.859
71670451|NCT01217112|142858092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.526||0.467|TWO_SIDED|90.0|-1.27|0.5|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.50|-1.27|0.467
71670452|NCT01217112|142858093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.406||0.124|TWO_SIDED|90.0|-1.32|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.05|-1.32|0.124
71670453|NCT01217112|142858093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.439||0.909|TWO_SIDED|90.0|-0.68|0.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.79|-0.68|0.909
71670454|NCT01217112|142858093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.392||0.245|TWO_SIDED|90.0|-1.12|0.2|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.20|-1.12|0.245
71787042|NCT00536198|143072372|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group comparison||||0.46
71787043|NCT00536198|143072372|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.0001
71787044|NCT00536198|143072372|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.69
71836981|NCT03400059|143180151|SUPERIORITY|||||||0.0102|||||||Chi-squared|||||||0.0102
71670455|NCT01217112|142858093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.412||0.382|TWO_SIDED|90.0|-1.05|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.33|-1.05|0.382
71670456|NCT01217112|142858094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.837||0.376|TWO_SIDED|90.0|-2.15|0.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.66|-2.15|0.376
71670457|NCT01217112|142858094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.908||0.688|TWO_SIDED|90.0|-1.15|1.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.89|-1.15|0.688
71670458|NCT01217112|142858094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.803||0.637|TWO_SIDED|90.0|-1.73|0.96|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.96|-1.73|0.637
71670459|NCT01217112|142858094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.849||0.355|TWO_SIDED|90.0|-2.22|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.63|-2.22|0.355
71670460|NCT01217112|142858095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.391||0.482|TWO_SIDED|90.0|-0.39|0.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.95|-0.39|0.482
71670461|NCT01217112|142858095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.489||0.708|TWO_SIDED|90.0|-0.65|1.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.02|-0.65|0.708
71670462|NCT01217112|142858095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.434||0.166|TWO_SIDED|90.0|-0.12|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.37|-0.12|0.166
71670463|NCT01217112|142858095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.408||0.424|TWO_SIDED|90.0|-0.37|1.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.03|-0.37|0.424
71670464|NCT01217112|142858096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.26||0.022|TWO_SIDED|90.0|0.94|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.94|0.022
71670465|NCT01217112|142858096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|1.532||0.014|TWO_SIDED|90.0|1.44|6.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.69|1.44|0.014
71670466|NCT01217112|142858096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|1.4||0.053|TWO_SIDED|90.0|0.45|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.25|0.45|0.053
71670467|NCT01217112|142858096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|1.299||0.012|TWO_SIDED|90.0|1.33|5.78|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.78|1.33|0.012
71670468|NCT01217112|142858097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.35|STANDARD_ERROR_OF_MEAN|1.463||0.032|TWO_SIDED|90.0|0.84|5.85|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.85|0.84|0.032
71670469|NCT01217112|142858097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|1.798||0.026|TWO_SIDED|90.0|1.18|7.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.35|1.18|0.026
71787045|NCT00536198|143072372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.84|TWO_SIDED|95.0|0.83|1.26|||Mixed Models Analysis|||Estimated mean difference from Cycle 1 to end point between active vs. placebo||1.26|0.83|0.84
71787046|NCT00536198|143072373|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
71787047|NCT00536198|143072373|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Change over time in both groups||||<0.001
71787048|NCT00536198|143072373|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||0.28
71787049|NCT00536198|143072373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.056|TWO_SIDED|95.0|0.3|1.19|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.19|0.30|0.056
71787050|NCT00536198|143072375|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||Group comparison||||0.30
71787051|NCT00536198|143072375|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.01
71787052|NCT00536198|143072375|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
71891939|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.22|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-14.64|23.08|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg vs Placebo Day 28||23.08|-14.64|
71891940|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.65|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.18|24.47|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 28||24.47|-11.18|
71670470|NCT01217112|142858097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.44|STANDARD_ERROR_OF_MEAN|1.626||0.046|TWO_SIDED|90.0|0.65|6.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.22|0.65|0.046
71670471|NCT01217112|142858097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.512||0.018|TWO_SIDED|90.0|1.26|6.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.45|1.26|0.018
71670472|NCT01217112|142858098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.806||0.294|TWO_SIDED|90.0|-0.52|2.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.25|-0.52|0.294
71670473|NCT01217112|142858098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|0.988||0.092|TWO_SIDED|90.0|0.05|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|0.05|0.092
71754323|NCT00385671|143011903|SUPERIORITY_OR_OTHER|||||||0.975||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.975
71754324|NCT00385671|143011903|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.448
71836982|NCT03400059|143180152|SUPERIORITY|||||||0.1615|||||||Chi-squared|||||||0.1615
71836983|NCT03400059|143180153|SUPERIORITY|||||||0.0798|||||||Chi-squared|||||||0.0798
71836984|NCT03400059|143180154|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.1300
71670474|NCT01217112|142858098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.26|STANDARD_ERROR_OF_MEAN|0.893||0.173|TWO_SIDED|90.0|-0.28|2.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||2.79|-0.28|0.173
71836985|NCT03400059|143180155|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.066|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0660
71836986|NCT03400059|143180156|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.0152|TWO_SIDED|||||posthoc|Van-Elteren|||||||0.0152
71836987|NCT05034952|143180188|SUPERIORITY|||||||0.3914|||||||ANCOVA|||||||0.3914
71836988|NCT05034952|143180188|SUPERIORITY|||||||0.1266|||||||ANCOVA|||||||0.1266
71836989|NCT05034952|143180188|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
71836990|NCT05034952|143180189|SUPERIORITY|||||||0.5476|||||||ANCOVA|||||||0.5476
71836991|NCT05034952|143180189|SUPERIORITY|||||||0.0825|||||||ANCOVA|||||||0.0825
71836992|NCT05034952|143180189|SUPERIORITY|||||||0.0036|||||||ANCOVA|||||||0.0036
71836993|NCT05034952|143180190|SUPERIORITY|||||||0.4712|||||||Cochran-Mantel-Haenszel|||||||0.4712
71836994|NCT05034952|143180190|SUPERIORITY|||||||0.1635|||||||Cochran-Mantel-Haenszel|||||||0.1635
71836995|NCT05034952|143180190|SUPERIORITY|||||||0.1158|||||||Cochran-Mantel-Haenszel|||||||0.1158
71836996|NCT05034952|143180191|SUPERIORITY|||||||0.2882|||||||Cochran-Mantel-Haenszel|||||||0.2882
71836997|NCT05034952|143180191|SUPERIORITY|||||||0.2344|||||||Cochran-Mantel-Haenszel|||||||0.2344
71836998|NCT05034952|143180191|SUPERIORITY|||||||0.1724|||||||Cochran-Mantel-Haenszel|||||||0.1724
71836999|NCT05034952|143180192|SUPERIORITY|||||||0.1343|||||||Cochran-Mantel-Haenszel|||||||0.1343
71837000|NCT05034952|143180192|SUPERIORITY|||||||0.4501|||||||Cochran-Mantel-Haenszel|||||||0.4501
71837001|NCT05034952|143180192|SUPERIORITY|||||||0.1009|||||||Cochran-Mantel-Haenszel|||||||0.1009
71837002|NCT06074523|143180240|EQUIVALENCE|Comparing three conditions in a basic science experiment in healthy adults.|partial eta squared|0.81|||<|0.001|TWO_SIDED||||||ANOVA|||Comparing Cued Suppression Task; Positive, Negative, and Neutral Cue condtions||||<.001
71837003|NCT06074523|143180241|EQUIVALENCE|P\<.05 criterion|cohen's d|0.24||||0.08|TWO_SIDED||||||t-test, 2 sided|||Comparing performance on target absent and target present trials||||.08
71670475|NCT01217112|142858098|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.837||0.545|TWO_SIDED|90.0|-0.92|1.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.95|-0.92|0.545
71754325|NCT00385671|143011903|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.||||0.280
71754326|NCT00385671|143011904|SUPERIORITY_OR_OTHER|||||||0.548||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.548
71754327|NCT00385671|143011904|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||0.599
71754328|NCT00385671|143011904|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.||||1.00
71754329|NCT00385671|143011905|SUPERIORITY_OR_OTHER|||||||0.905||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.905
71754330|NCT00385671|143011905|SUPERIORITY_OR_OTHER|||||||0.368||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.368
71754331|NCT00385671|143011905|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.||||0.200
71754332|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.572
71754333|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.||||0.345
71787053|NCT00536198|143072375|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12||||0.06|TWO_SIDED|95.0|0.92|1.35|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.35|0.92|0.06
71787054|NCT00536198|143072376|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||ANOVA|||Group comparison||||0.80
71787055|NCT00536198|143072376|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71787056|NCT00536198|143072376|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.43
71787057|NCT00536198|143072376|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11||||0.61|TWO_SIDED|95.0|0.85|1.45|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo||1.45|0.85|0.61
71787058|NCT00536198|143072377|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||ANOVA|||Group comparison||||0.83
71787059|NCT00536198|143072377|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71787060|NCT00536198|143072377|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.02
71787061|NCT00536198|143072377|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.169|TWO_SIDED|95.0|0.96|1.25|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.25|0.96|0.169
71787062|NCT00536198|143072378|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||ANOVA|||Group comparison||||0.37
71787063|NCT00536198|143072378|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71670476|NCT01217112|142858099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.67|STANDARD_ERROR_OF_MEAN|1.214||0.038|TWO_SIDED|90.0|0.59|4.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.75|0.59|0.038
71670477|NCT01217112|142858099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|1.486||0.004|TWO_SIDED|90.0|2.16|7.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.26|2.16|0.004
71670478|NCT01217112|142858099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.35||0.088|TWO_SIDED|90.0|0.09|4.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||4.72|0.09|0.088
71670479|NCT01217112|142858099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|1.252||0.01|TWO_SIDED|90.0|1.39|5.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||5.68|1.39|0.010
71670480|NCT01217112|142858100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.814||0.064|TWO_SIDED|90.0|0.42|6.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||6.64|0.42|0.064
71670481|NCT01217112|142858100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.55|STANDARD_ERROR_OF_MEAN|2.237||0.008|TWO_SIDED|90.0|2.72|10.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||10.38|2.72|0.008
71670482|NCT01217112|142858100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.65|STANDARD_ERROR_OF_MEAN|2.016||0.084|TWO_SIDED|90.0|0.19|7.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.10|0.19|0.084
71670483|NCT01217112|142858100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.871||0.041|TWO_SIDED|90.0|0.84|7.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.25|0.84|0.041
71670484|NCT01217112|142858101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.129|TWO_SIDED|90.0|-0.14|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.14|0.129
71670485|NCT01217112|142858101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.051||0.961|TWO_SIDED|90.0|-0.08|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.09|-0.08|0.961
71670486|NCT01217112|142858101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.048||0.128|TWO_SIDED|90.0|-0.16|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.01|-0.16|0.128
71670487|NCT01217112|142858101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.045||0.3|TWO_SIDED|90.0|-0.12|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.03|-0.12|0.300
71670488|NCT01217112|142858102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|5.38||0.625|TWO_SIDED|90.0|-6.37|11.67|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||11.67|-6.37|0.625
71670489|NCT01217112|142858102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.77|STANDARD_ERROR_OF_MEAN|5.519||0.226|TWO_SIDED|90.0|-2.48|16.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||16.02|-2.48|0.226
71787064|NCT00536198|143072378|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.73
71787065|NCT00536198|143072378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.08||||0.13|TWO_SIDED|95.0|0.91|1.28|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.28|0.91|0.13
71787066|NCT00536198|143072379|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||ANOVA|||Group comparison||||0.31
71787067|NCT00536198|143072379|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71787068|NCT00536198|143072379|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||0.46
71787069|NCT00536198|143072379|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.94|TWO_SIDED|95.0|0.96|1.23|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.23|0.96|0.94
71787070|NCT00536198|143072380|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Group comparison||||<0.001
71787071|NCT00536198|143072380|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||Change over time in both groups||||<0.001
71787072|NCT00536198|143072380|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|||Group by time: comparison rates of change||||<0.01
71670490|NCT01217112|142858102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|5.103||0.904|TWO_SIDED|90.0|-7.94|9.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||9.18|-7.94|0.904
71670491|NCT01217112|142858102|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|5.71||0.285|TWO_SIDED|90.0|-3.41|15.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||15.75|-3.41|0.285
71754334|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.||||0.699
71787073|NCT00536198|143072380|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.22||||0.027|TWO_SIDED|95.0|1.05|1.41|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo||1.41|1.05|0.027
71787074|NCT00536198|143072381|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Group comparison||||0.01
71787075|NCT00536198|143072381|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Group by time: comparison rates of change||||<0.001
71787076|NCT00536198|143072381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.056|TWO_SIDED|95.0|0.3|1.02|||Mixed Models Analysis|||Estimated mean difference between active and placebo groups at end-point only||1.02|0.30|0.056
71787077|NCT03791489|143072428|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71787078|NCT03791489|143072429|SUPERIORITY||||||<|0.03||||||Threshold for statistical significance = p\<0.05.|t-test, 2 sided|||||||<0.03
71787079|NCT01691781|143072430|SUPERIORITY|||||||0.049||||||This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.049
71787080|NCT01691781|143072430|SUPERIORITY|||||||0.8||||||This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).||||0.80
71787081|NCT01691781|143072431|SUPERIORITY|||||||0.22||||||This p-value reflects the comparison of means among the primary hyperparathyroidism group only.|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.22
71787082|NCT01691781|143072431|SUPERIORITY|||||||0.86||||||This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.86
71837004|NCT06074523|143180242|OTHER||Slope|-0.37||||0.007|TWO_SIDED|95.0|-0.5803|-0.1135|||correlation|||Relationship between Cued Attention Negative Cue Benefit (Neutral Cue RT- Negative Cue RT) and working memory capacity.||-0.1135|-0.5803|.007
71670492|NCT01217112|142858103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.568||0.138|TWO_SIDED|90.0|-1.81|0.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.10|-1.81|0.138
71787083|NCT01691781|143072432|SUPERIORITY|||||||0.48||||||This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.||||0.48
71787084|NCT01691781|143072432|SUPERIORITY|||||||0.8||||||This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.||||0.80
71787085|NCT00850564|143072457|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Paired t-test|||Paired t-test comparing baseline and 2 week mean overnight growth hormone||||<0.005
71787086|NCT00850564|143072458|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Paired t-test|||Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.||||0.61
71787087|NCT02700815|143072459|SUPERIORITY||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.277||0.0303|TWO_SIDED|95.0|-1.15|-0.06|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.06|-1.15|0.0303
71787088|NCT02700815|143072459|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.197||0.2886|TWO_SIDED|95.0|-0.18|0.6|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.60|-0.18|0.2886
71837005|NCT06074523|143180243|OTHER||Slope|-0.27||||0.046|TWO_SIDED|95.0|-0.5015|-0.002414|||correlation|||Correlation of Inattentive Traits subscale and learned suppression (difference in RT between target absent and target present trials)||-0.002414|-0.5015|.046
71845516|NCT00458783|143205495|SUPERIORITY||Odds Ratio (OR)|0.77||||0.08|TWO_SIDED|95.0|0.5|1.2|||generalized estimating equation (GEE)|Generalized estimating equation (GEE) distinct-effects model||||1.2|0.50|0.08
71837006|NCT03143153|143180263|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|98.6|0.46|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model.|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.90|0.46|0.0010
71837007|NCT03143153|143180263|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.001|TWO_SIDED|95.0|0.49|0.84||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy.||0.84|0.49|0.0010
71837008|NCT03143153|143180263|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|99.5|0.37|0.8||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.80|0.37|<0.0001
71837009|NCT03143153|143180263|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.71|0.41|<0.0001
71837010|NCT03143153|143180264|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|98.5|0.73|1.43||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.43|0.73|0.8958
71837011|NCT03143153|143180264|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8958|TWO_SIDED|95.0|0.78|1.34||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.34|0.78|0.8958
71837012|NCT03143153|143180264|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|98.5|0.46|0.92||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.92|0.46|0.0023
71837013|NCT03143153|143180264|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0023|TWO_SIDED|95.0|0.49|0.86||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.86|0.49|0.0023
71670493|NCT01217112|142858103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.547||0.505|TWO_SIDED|90.0|-1.28|0.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||0.55|-1.28|0.505
71837014|NCT03143153|143180265|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||95.0|0.65|0.95||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.95|0.65|0.0110
71837015|NCT03143153|143180265|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.011||98.2|0.62|0.98||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT.|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||0.98|0.62|0.0110
71837016|NCT03143153|143180265|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021||99.1|0.58|0.96||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.96|0.58|0.0021
71670494|NCT01217112|142858103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.54||0.743|TWO_SIDED|90.0|-0.73|1.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.08|-0.73|0.743
71837017|NCT03143153|143180265|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0021|TWO_SIDED|95.0|0.61|0.9||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.90|0.61|0.0021
71837018|NCT03143153|143180266|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|1.04|1.52|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: Nivolumab + Ipilimumab over Arm C: Chemotherapy||1.52|1.04|
71837019|NCT03143153|143180266|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|95.0|0.67|0.99||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||0.99|0.67|0.0355
71837020|NCT03143153|143180266|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0355|TWO_SIDED|98.5|0.64|1.04||Log-rank test stratified by ECOG Performance Status (0 vs 1), number of organs with metastases (\<= 1 vs. \>= 2), PD-L1 status (\>= 1% vs. \< 1% or indeterminate) as recorded in IRT|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm B: Nivolumab + Chemotherapy over Arm C: Chemotherapy||1.04|0.64|0.0355
71837021|NCT02312557|143180268|OTHER||Proportion|0.19|||<|0.01|TWO_SIDED|95.0|0.09|0.29|||One-sample binomial test of proportion|||||0.29|0.09|<0.01
71837022|NCT02736409|143180282|SUPERIORITY||Difference in Proportion|-0.19||||0.131|TWO_SIDED|95.0|-0.452|0.082|||Fisher Exact|||||0.082|-0.452|0.131
71845517|NCT00458783|143205496|SUPERIORITY||Odds Ratio, log|0.64|||||TWO_SIDED|95.0|0.25|1.6||||||||1.6|0.25|
71845518|NCT00458783|143205497|SUPERIORITY||Odds Ratio, log|0.72|||||TWO_SIDED|95.0|0.26|2.0||||||||2.0|0.26|
71845519|NCT00458783|143205498|SUPERIORITY||Odds Ratio, log|0.9|||||TWO_SIDED|95.0|0.59|1.4||||||||1.4|0.59|
71845520|NCT00458783|143205499|SUPERIORITY||Odds Ratio, log|0.86|||||TWO_SIDED|95.0|0.43|1.8||||||||1.8|0.43|
71845521|NCT00458783|143205500|SUPERIORITY||Risk Ratio, log|0.81|||||TWO_SIDED|95.0|0.24|2.8||||||||2.8|0.24|
71670495|NCT01217112|142858103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.565||0.54|TWO_SIDED|90.0|-0.6|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||1.29|-0.60|0.540
71670496|NCT01217112|142858105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|1.664||0.701|TWO_SIDED|90.0|-2.14|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.43|-2.14|0.701
71787089|NCT02700815|143072459|SUPERIORITY||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|0.197||0.0003|TWO_SIDED|95.0|-1.1|-0.33|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.33|-1.10|0.0003
71787090|NCT02700815|143072460|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.221||0.0956|TWO_SIDED|95.0|-0.8|0.07|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between placebo and combination therapy diclofenac + capsaicin||0.07|-0.80|0.0956
71787091|NCT02700815|143072460|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.157||0.0564|TWO_SIDED|95.0|-0.01|0.61|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin||0.61|-0.01|0.0564
71787092|NCT02700815|143072460|SUPERIORITY||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.157||0.0004|TWO_SIDED|95.0|-0.87|-0.25|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.25|-0.87|0.0004
71787093|NCT02700815|143072461|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.238||0.0347|TWO_SIDED|95.0|-0.97|-0.04|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between placebo and combination therapy diclofenac + capsaicin||-0.04|-0.97|0.0347
71837023|NCT05285618|143180351|OTHER|A linear mixed model accounted for repeated measures ('subject\_id' as a random factor). No power calculation was performed, but the sample size (1,485 observations, 6 subjects) supports robust estimation.||||||0.002||||||P-values are unadjusted for multiple comparisons, as the analysis focused on a limited number of predictors. The a priori threshold for statistical significance was set at p\<0.05.|Mixed Models Analysis|||The model tested whether stimulation delay ('abs\_delay'), retinal distance ('dist\_ret'), and their interaction ('abs\_delay:dist\_ret') affect the number of elicited phosphenes ('num\_phosphenes').|We hypothesize that the parameter 'dist\_ret' may influence the number of phosphenes perceived ('num\_phosphenes'), while the roles of 'abs\_delay' and its interaction with 'dist\_ret' may be less pronounced. Further evaluation of these parameters will be conducted in the Results section|||0.002
71837024|NCT05722704|143180354|SUPERIORITY||Median Difference (Net)|0.118|STANDARD_DEVIATION|0.05||0.986|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.986
71837025|NCT05722704|143180355|SUPERIORITY||Median Difference (Net)|0.016|STANDARD_DEVIATION|0.05|<|0.118|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.118
71837026|NCT05722704|143180356|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.225|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.225
71670497|NCT01217112|142858105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|1.662||0.006|TWO_SIDED|90.0|1.99|7.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||7.55|1.99|0.006
71837027|NCT05722704|143180357|SUPERIORITY||Median Difference (Net)|95.0|STANDARD_DEVIATION|0.05||0.424|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.424
71670498|NCT01217112|142858105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.589||0.542|TWO_SIDED|90.0|-1.68|3.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.64|-1.68|0.542
71670499|NCT01217112|142858105|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.627||0.827|TWO_SIDED|90.0|-2.36|3.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.||3.08|-2.36|0.827
71670500|NCT03192488|142858106|SUPERIORITY||Mean Difference (Final Values)|1.06||||0.047|TWO_SIDED|95.0|0.01|2.11|||ANOVA|"The overall model was adjusted for the co-variate VO2max."||||2.11|0.01|0.047
71670501|NCT03192488|142858107|SUPERIORITY|||||||0.327|||||||ANOVA|||||||0.327
71845522|NCT00458783|143205501|SUPERIORITY||Odds Ratio, log|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||||1.5|0.80|
71845523|NCT00458783|143205502|SUPERIORITY||Odds Ratio, log|0.43|||||TWO_SIDED|95.0|0.16|1.1||||||||1.1|0.16|
71845524|NCT00458783|143205503|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.39|1.7||||||||1.7|0.39|
71845525|NCT00458783|143205504|SUPERIORITY||Odds Ratio, log|0.82|||||TWO_SIDED|95.0|0.5|1.3||||||||1.3|0.50|
71845526|NCT00458783|143205505|SUPERIORITY||Odds Ratio, log|0.76|||||TWO_SIDED|95.0|0.18|3.2||||||||3.2|0.18|
71845527|NCT00458783|143205506|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox||The 95%CI is interim adjusted.|||1.29|0.94|0.9
71754335|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.954
71754336|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.734||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.||||0.734
71754337|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.||||0.693
71837028|NCT04784559|143180398|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8751|TWO_SIDED|95.0|0.727|1.53||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors,|Plitidepsin 2.5 mg arm versus Control arm||1.53|0.727|0.8751
71754338|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.720
71754339|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.722
71754340|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.||||0.480
71754341|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.498
71754342|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.865||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.865
71754343|NCT00385671|143011906|SUPERIORITY_OR_OTHER|||||||0.408||95.0||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.||||0.408
71754344|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.635|TWO_SIDED|95.0|-2.18|1.33||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||1.33|-2.18|0.635
71837029|NCT04784559|143180398|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.0625|TWO_SIDED|95.0|0.96|1.96||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.96|0.960|0.0625
71845528|NCT00458783|143205507|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.07|TWO_SIDED|95.0|0.85|1.18|||Regression, Cox||The 95%CI is interim adjusted.|||1.18|0.85|0.07
71845529|NCT01737398|143205508|OTHER||Least Square Mean Difference|-19.73||||4e-08|TWO_SIDED|95.0|-26.43|-13.03|||MMRM|||||-13.03|-26.43|0.00000004
71670502|NCT03192488|142858107|SUPERIORITY|||||||0.557|||||||ANOVA|||||||0.557
71787094|NCT02700815|143072461|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.169||0.0622|TWO_SIDED|95.0|-0.02|0.65|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin||0.65|-0.02|0.0622
71787095|NCT02700815|143072461|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.169|<|0.0001|TWO_SIDED|95.0|-1.01|-0.35|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin||-0.35|-1.01|<0.0001
71787096|NCT02700815|143072462|SUPERIORITY||Odds Ratio (OR)|1.882||||0.0202|TWO_SIDED|95.0|1.1|3.21|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.21|1.10|0.0202
71787097|NCT02700815|143072462|SUPERIORITY||Odds Ratio (OR)|0.732||||0.1206|TWO_SIDED|95.0|0.49|1.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.09|0.49|0.1206
71787098|NCT02700815|143072462|SUPERIORITY||Odds Ratio (OR)|1.629||||0.0122|TWO_SIDED|95.0|1.11|2.39|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||2.39|1.11|0.0122
71787099|NCT02700815|143072463|SUPERIORITY||Odds Ratio (OR)|1.729||||0.0643|TWO_SIDED|95.0|0.97|3.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.09|0.97|0.0643
71787100|NCT02700815|143072463|SUPERIORITY||Odds Ratio (OR)|0.833||||0.3479|TWO_SIDED|95.0|0.57|1.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||1.22|0.57|0.3479
71787101|NCT02700815|143072463|SUPERIORITY||Odds Ratio (OR)|2.125||||0.0004|TWO_SIDED|95.0|1.4|3.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.||3.22|1.40|0.0004
71787102|NCT02700815|143072464|SUPERIORITY||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.313||0.0008|TWO_SIDED|95.0|-1.67|-0.44|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.44|-1.67|0.0008
71787103|NCT02700815|143072464|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.223||0.3726|TWO_SIDED|95.0|-0.24|0.64|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||0.64|-0.24|0.3726
71787104|NCT02700815|143072464|SUPERIORITY||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.56|-0.68|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.||-0.68|-1.56|<0.0001
71787105|NCT02700815|143072465|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.844||0.881|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.53|-1.78|0.8810
71845530|NCT01737398|143205509|OTHER||Least Square Mean Difference|-11.68||||0.0006|TWO_SIDED|95.0|-18.29|-5.06|||MMRM|||||-5.06|-18.29|0.0006
71837030|NCT04784559|143180399|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.5945|TWO_SIDED|95.0|0.655|1.37||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||1.37|0.655|0.5945
71837031|NCT04784559|143180399|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3358|TWO_SIDED|95.0|0.827|1.7||Unadjusted 2-sided p-value, for multiplicity adjustment uses the Hochberg step-up procedure|Log Rank|Stratified log-rank test, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Stratified Cox proportional-hazards regression model, including the fixed effect of the treatment group and levels of the randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||1.70|0.827|0.3358
71837032|NCT04784559|143180400|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7252|TWO_SIDED|95.0|0.604|2.06||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 2.5 mg arm versus Control arm||2.06|0.604|0.7252
71837033|NCT04784559|143180400|SUPERIORITY||Odds Ratio (OR)|1.69||||0.091|TWO_SIDED|95.0|0.92|3.11||2-sided|p-value based on proportional odds model|Proportional odds model with fixed effects of treatment group and randomisation stratification factors|Adjusted Odds Ratio and 95% CI based on a proportional odds model with fixed effects of treatment group and randomisation stratification factors|Plitidepsin 1.5 mg arm versus Control arm||3.11|0.920|0.0910
71837034|NCT05671029|143180423|NON_INFERIORITY|Null hypothesis: difference to placebo of change from baseline QTcF ≥ 10 ms.|Prediction @ mean max concentration|0.8|||<|0.05|TWO_SIDED|90.0|-1.3|2.9|||Mixed Models Analysis|||||2.9|-1.3|<0.05
71837035|NCT05481216|143180461|OTHER|Unadjusted and adjusted hazard ratios (HR) will be calculated using a proportional Cox regression model. The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||||2.29|0.73|
71837036|NCT05481216|143180461|OTHER||Adjusted Hazard Ratio|1.3|||||TWO_SIDED|95.0|0.73|2.29||||||The adjusted variables were body mass index (BMI), dementia, peripheral vascular disease, history of pneumonia, connective tissue disease, liver disease, diabetes, chronic kidney disease, glucocorticoids, hydroxychloroquine, tocilizumab, and anti-IL6 inhibitors.||2.29|0.73|
71837037|NCT05481216|143180465|OTHER|||||||0.009|||||||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19.||||0.009
71837038|NCT05481216|143180486|OTHER||Odds Ratio (OR)|0.85||||0.033|TWO_SIDED|95.0|0.74|0.99|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||0.99|0.74|0.033
71837039|NCT05481216|143180487|OTHER||Odds Ratio (OR)|1.93||||0.012|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||3.22|1.16|0.012
71837040|NCT05481216|143180488|OTHER||Odds Ratio (OR)|0.99||||0.458|TWO_SIDED|95.0|0.95|1.02|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||1.02|0.95|0.458
71837041|NCT05481216|143180489|OTHER||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.61|4.57|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||4.57|1.61|<0.001
71837042|NCT05481216|143180490|OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.34|2.25|||Regression, Logistic|||Conditional logistic regression models accounting for case-control matching will be used to identify risk factors for advanced immunodeficiency associated with COVID-19. Odds ratio (OR), and the 95% confidence intervals of the OR will be calculated||2.25|1.34|<0.001
71837043|NCT04005716|143180491|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.004|TWO_SIDED|95.0|0.61|0.93|||Log Rank|Stratified log rank test with ECOG performance status, and investigator chosen platinum as stratification factors.|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|The null hypothesis stated that the overall survival in Arm A (Tislelizumab + Chemotherapy) is less than or equal to that in Arm B (the placebo group), while the alternative hypothesis posits that the overall survival in Arm A is greater than that in Arm B.||0.93|0.61|0.0040
71837044|NCT04005716|143180492|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.78|||Log Rank|One-sided log-rank test p-value, stratified by ECOG performance status (1 vs 0) and type of platinum therapy (carboplatin vs cisplatin).|The hazard ratio was estimated using a stratified Cox regression model with Efron's method for ties, stratified by ECOG performance status and investigator-selected platinum agents, with Arm B as the reference group.|||0.78|0.52|<0.0001
71837045|NCT04005716|143180493|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.9|1.96|||||Odds ratio was calculated using Cochran-Mantel-Haenszel estimates and stratified by ECOG performance (1 vs 0) and platinum (Carboplatin vs Cisplatin)|||1.96|0.90|
71837046|NCT04005716|143180500|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.642|1.33|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-C30 Physical Functioning Score||1.330|0.642|
71845531|NCT06307457|143205552|OTHER|||||||0.031|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.031
71670503|NCT01366417|142858145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|0.133|<|0.05|TWO_SIDED|95.0|1.95|2.48|||ANOVA|||Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm\^2 at 30 seconds after application.||2.48|1.95|< 0.05
71670504|NCT01366417|142858145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.25|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|1.99|2.51|||ANOVA|||hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm\^2 at 30 seconds after treatment||2.51|1.99|<0.05
71754345|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.092|TWO_SIDED|95.0|-3.24|0.24||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.24|-3.24|0.092
71754346|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.221|TWO_SIDED|95.0|-2.8|0.65||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.||0.65|-2.80|0.221
71754347|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.974|TWO_SIDED|95.0|-0.88|0.85||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.85|-0.88|0.974
71754348|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.093|TWO_SIDED|95.0|-1.63|0.13||P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.13|-1.63|0.093
71754349|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.091|TWO_SIDED|95.0|-1.59|0.12||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.||0.12|-1.59|0.091
71754350|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.733|TWO_SIDED|95.0|-0.75|0.52||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.||0.52|-0.75|0.733
71754351|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.102|TWO_SIDED|95.0|-1.15|0.11||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.11|-1.15|0.102
71754352|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.193|TWO_SIDED|95.0|-1.04|0.21||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.||0.21|-1.04|0.193
71754353|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.584|TWO_SIDED|95.0|-0.76|0.43||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.43|-0.76|0.584
71837047|NCT04005716|143180500|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.473|1.123|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Coughing Score||1.123|0.473|
71670505|NCT01366417|142858146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.65|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.39|2.91|||ANOVA|||Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.||2.91|2.39|<0.05
71670506|NCT01366417|142858146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.6|STANDARD_DEVIATION|0.133|<|0.05|TWO_SIDED|95.0|2.33|2.86|||ANOVA|||Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment||2.86|2.33|<0.05
71670507|NCT01839708|142858147|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71837048|NCT04005716|143180500|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.485|1.057|||||Hazard ratio was based on unstratified Cox regression model including treatment as covariate.|Analyses of Time to Deterioration of EORTC QLQ-LC13 Chest Pain Score||1.057|0.485|
71837049|NCT02226276|143180523|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71837050|NCT02226276|143180524|OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71837051|NCT05592418|143180581|SUPERIORITY||Mean Difference (Final Values)|0.0288||||0.9851|TWO_SIDED|95.0|-3.0397|3.0972|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.0972|-3.0397|0.9851
71837052|NCT05592418|143180582|SUPERIORITY||Mean Difference (Final Values)|-1.9076||||0.3095|TWO_SIDED|95.0|-5.6279|1.8128|||ANCOVA|||||1.8128|-5.6279|0.3095
71837053|NCT05592418|143180583|SUPERIORITY||Mean Difference (Final Values)|0.6086||||0.7663|TWO_SIDED|95.0|-3.4656|4.6829|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.6829|-3.4656|0.7663
71837054|NCT05592418|143180584|SUPERIORITY||Mean Difference (Final Values)|23.7749||||0.3162|TWO_SIDED|95.0|-23.2463|70.7962|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||70.7962|-23.2463|0.3162
71837055|NCT05592418|143180585|SUPERIORITY|||||||||||||||||P-value is from The Cochran-Mantel-Haenszel test (CMH) stratified by stratification factors|Since all patients analyzed achieved MCID, there are no comparison results|||
71837056|NCT05592418|143180586|SUPERIORITY||Mean Difference (Final Values)|-3.2342||||0.4232|TWO_SIDED|95.0|-11.2586|4.7901|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||4.7901|-11.2586|0.4232
71670508|NCT01839708|142858148|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71837057|NCT05592418|143180587|SUPERIORITY||Mean Difference (Final Values)|-0.5161||||0.7823|TWO_SIDED|95.0|-4.2356|3.2035|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|||3.2035|-4.2356|0.7823
71837058|NCT05592418|143180589|SUPERIORITY||Mean Difference (Final Values)|0.2779||||0.5185|TWO_SIDED|95.0|-0.5775|1.1333|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|||1.1333|-0.5775|0.5185
71837059|NCT05592418|143180590|OTHER||||||||||||||||||No patients were hospitalized.|||
71837060|NCT05592418|143180592|SUPERIORITY||Mean Difference (Final Values)|169.389||||0.2175|TWO_SIDED|95.0|-105.892|444.6702|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo.|444.6702|-105.892|0.2175
71837061|NCT05592418|143180593|SUPERIORITY||Mean Difference (Final Values)|-56.9984||||0.2086|TWO_SIDED|95.0|-147.021|33.0241|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|33.0241|-147.021|0.2086
71837062|NCT05592418|143180594|SUPERIORITY||Mean Difference (Final Values)|0.1733||||0.0975|TWO_SIDED|95.0|-0.0327|0.3792|||ANCOVA||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo||LS Mean difference = LS Mean of Ampligen® - LS Mean of Placebo|0.3792|-0.0327|0.0975
71837063|NCT05592418|143180596|SUPERIORITY||Mean Difference (Final Values)|20.7131||||0.4545|TWO_SIDED|95.0|-34.4079|75.8341|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||75.8341|-34.4079|0.4545
71837064|NCT05592418|143180597|SUPERIORITY||Mean Difference (Final Values)|44.1231||||0.0333|TWO_SIDED|95.0|4.6338|83.6123|||ANCOVA||LS Mean Difference - LS Mean of Ampligen® - LS Mean of Placebo|||83.6123|4.6338|0.0333
71837065|NCT01781468|143180611|SUPERIORITY|||||||0.9601|||||||Fisher Exact|||||||0.9601
71837066|NCT01781468|143180612|SUPERIORITY|||||||0.7877|||||||Fisher Exact|||||||0.7877
71837067|NCT01781468|143180613|SUPERIORITY|||||||0.3272|||||||Kruskal-Wallis|||||||0.3272
71837068|NCT01781468|143180614|SUPERIORITY|||||||0.9122|||||||Kruskal-Wallis|||Baseline to Week 4||||0.9122
71837069|NCT01781468|143180614|SUPERIORITY|||||||0.8559|||||||Kruskal-Wallis|||Baseline to Week 8||||0.8559
71837070|NCT04150718|143180672|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at \<0.05|ANOVA|Repeated measures ANOVA, main effect of time, F(1,35) =4.73||||||<0.05
71837071|NCT04150718|143180673|OTHER||||||<|0.05||||||a priori threshold for statistical significance set at p\<0.05.|ANOVA|Repeated Measures ANOVA, main effect of time, F(1,39) = 4.20||||||<0.05
71837072|NCT04150718|143180674|OTHER||||||<|0.001||||||a priori threshold for statistical significance set at p \<0.05|ANOVA|Repeated measures ANOVA interaction, F(1,48) = 61.849||||||<0.001
71837073|NCT03661840|143180729|SUPERIORITY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|17.0||0.82|TWO_SIDED|95.0|-31.0|39.0||Unadjusted model comparing the mean difference (change from 12 weeks - baseline) in outcome by intervention group.|Regression, Linear|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||39|-31|0.82
71837074|NCT03661840|143180730|SUPERIORITY||Mean Difference (Final Values)|12.0|STANDARD_ERROR_OF_MEAN|6.4||0.06|TWO_SIDED|95.0|-0.7|25.0||Unadjusted model comparing the change in outcome by intervention group|Regression, Linear|||||25|-0.7|0.06
71837075|NCT03661840|143180730|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||ANOVA|||Sample size was estimated using d= 0.61, with power at 0.80 and α = .05, two-tailed. It is assumed that the correlation between pre and post-test measures will be high at .5. With these parameters and using repeated measures ANOVA to evaluate treatment difference, sample size is powered for clinical outcomes at 92 participants; with an estimated 30% attrition and conservatively including the possibility of screening failures, a maximum sample of 140 participants will be targeted for enrollment.||||0.05
71837076|NCT02120456|143180804|SUPERIORITY||Rate ratio|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.58|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.58|0.34|<0.001
71837077|NCT02120456|143180804|SUPERIORITY||Rate ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.44|0.73|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.73|0.44|<0.001
71837078|NCT02120456|143180804|SUPERIORITY||Rate ratio|1.26||||0.058|TWO_SIDED|95.0|0.99|1.6|||Negative binominal regression|||||1.60|0.99|0.058
71670509|NCT01839708|142858149|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71670510|NCT01839708|142858150|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71670511|NCT01839708|142858151|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71837079|NCT02120456|143180805|SUPERIORITY||Ratio of clearance rates|1.05||||0.94|TWO_SIDED|95.0|0.3|4.73|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.73|0.30|0.94
71837080|NCT02120456|143180805|SUPERIORITY||Ratio of clearance rates|1.0||||1|TWO_SIDED|95.0|0.28|4.51|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||4.51|0.28|1.00
71837081|NCT02120456|143180805|SUPERIORITY||Ratio of clearance rates|0.95||||0.93|TWO_SIDED|95.0|0.31|2.89|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||2.89|0.31|0.93
71837082|NCT02120456|143180806|SUPERIORITY||Ratio of clearance rates|2.88||||0.003|TWO_SIDED|95.0|1.36|7.85|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.85|1.36|0.003
71754354|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.077|TWO_SIDED|95.0|-1.12|0.06||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.06|-1.12|0.077
71787106|NCT02700815|143072465|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.601||0.6094|TWO_SIDED|95.0|-0.87|1.49|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.49|-0.87|0.6094
71787107|NCT02700815|143072465|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|0.602||0.2047|TWO_SIDED|95.0|-0.42|1.95|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||1.95|-0.42|0.2047
71787108|NCT02700815|143072466|SUPERIORITY||Mean Difference (Net)|1.65|STANDARD_ERROR_OF_MEAN|1.339||0.2193|TWO_SIDED|95.0|-0.98|4.27|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||4.27|-0.98|0.2193
71837083|NCT02120456|143180806|SUPERIORITY||Ratio of clearance rates|2.84||||0.004|TWO_SIDED|95.0|1.35|7.74|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||7.74|1.35|0.004
71670512|NCT01839708|142858152|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71754355|NCT00385671|143011907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.221|TWO_SIDED|95.0|-0.95|0.22||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.||0.22|-0.95|0.221
71754356|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.096|TWO_SIDED|95.0|-3.96|0.32||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||0.32|-3.96|0.096
71837084|NCT02120456|143180806|SUPERIORITY||Ratio of clearance rates|0.99||||0.95|TWO_SIDED|95.0|0.66|1.47|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.||1.47|0.66|0.95
71837085|NCT02243709|143180829|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
71837086|NCT03443323|143180840|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
71837087|NCT03443323|143180841|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (OTMP skills \[COSS-P, COSS-T\]).|Mixed Models Analysis|||||||<.001
71837088|NCT03443323|143180842|SUPERIORITY|||||||0.007||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||0.007
71837089|NCT03443323|143180843|SUPERIORITY||||||<|0.001||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (homework performance \[HPC, HPQ-T\]).|Mixed Models Analysis|||||||<.001
71670513|NCT01839708|142858153|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71787109|NCT02700815|143072466|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.949||0.7672|TWO_SIDED|95.0|-1.58|2.15|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||2.15|-1.58|0.7672
71787110|NCT02700815|143072466|SUPERIORITY||Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.0339|TWO_SIDED|95.0|0.15|3.88|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.||3.88|0.15|0.0339
71787111|NCT00524368|143072467|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.|Difference in proportion of response|0.0019|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.054|0.092|||Regression, Logistic|The model includes treatment as factor and baseline viral load (log10) as covariate.|Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.|Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.||0.092|-0.054|<0.001
71787112|NCT00524368|143072468|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.|Difference in proportion of response|0.007|STANDARD_ERROR_OF_MEAN|0.034|<|0.001|TWO_SIDED|95.0|-0.06|0.075|||Regression, Logistic|A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.|Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)|||0.075|-0.060|<0.001
71787113|NCT00524368|143072469|SUPERIORITY_OR_OTHER||Difference between least square means|-0.003|STANDARD_ERROR_OF_MEAN|0.094||0.977|TWO_SIDED|95.0|-0.188|0.182|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.|||0.182|-0.188|0.977
71787114|NCT00524368|143072470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.094||0.917|TWO_SIDED|95.0|0.824|1.191|||Cox proportional hazards|Including treatment as fixed factor and baseline plasma viral load as a covariate||||1.191|0.824|0.917
71787115|NCT00524368|143072471|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.945|STANDARD_ERROR_OF_MEAN|0.154||0.716|TWO_SIDED|95.0|0.699|1.279|||Regression, Cox|Including baseline log10 viral load as covariate||||1.279|0.699|0.716
71787116|NCT00524368|143072472|SUPERIORITY_OR_OTHER||Difference in least square means|-0.03|STANDARD_ERROR_OF_MEAN|0.072||0.711|TWO_SIDED|95.0|-0.169|0.115|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)|||0.115|-0.169|0.711
71787117|NCT00524368|143072473|SUPERIORITY_OR_OTHER||Difference in least square means|-5.95|STANDARD_ERROR_OF_MEAN|10.26||0.562|TWO_SIDED|95.0|-26.09|14.2|||ANCOVA|The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||14.20|-26.09|0.562
71787118|NCT00524368|143072474|SUPERIORITY_OR_OTHER||Difference in least square means|0.55|STANDARD_ERROR_OF_MEAN|1.79||0.761|TWO_SIDED|95.0|-2.97|4.06|||ANCOVA|Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.|||4.06|-2.97|0.761
71670514|NCT01839708|142858154|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71787119|NCT02785354|143072539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.51|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).||0.66|0.51|<0.0001
71787120|NCT02785354|143072539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0006|TWO_SIDED|95.0|0.75|0.92|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.92|0.75|0.0006
71787121|NCT02785354|143072540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.66|0.46|<0.0001
71670515|NCT01839708|142858155|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71670516|NCT01839708|142858156|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71670517|NCT01839708|142858157|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71670518|NCT01839708|142858158|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71670519|NCT01839708|142858159|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71670520|NCT01839708|142858160|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71787122|NCT02785354|143072540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.58|0.79|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||0.79|0.58|<0.0001
71670521|NCT01836471|142858192|SUPERIORITY_OR_OTHER||least squares mean|0.01|STANDARD_ERROR_OF_MEAN|0.038||0.7269|TWO_SIDED|90.0|-0.5|0.08|||Mixed Models Analysis|||||0.08|-0.5|0.7269
71670522|NCT01836471|142858193|SUPERIORITY_OR_OTHER||least sqares mean|0.01|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|-0.08|0.09||||||||0.09|-0.08|
71670523|NCT01836471|142858193|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|90.0|-0.04|0.13||||||||0.13|-0.04|
71670524|NCT01836471|142858193|SUPERIORITY_OR_OTHER||least squares mean|-0.04|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|90.0|-0.13|0.05||||||||0.05|-0.13|
71670525|NCT01836471|142858194|SUPERIORITY_OR_OTHER|||||||0.9179|||||||Mixed Models Analysis|||||||0.9179
71670526|NCT01836471|142858195|SUPERIORITY_OR_OTHER||least squares mean|-0.02|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|95.0|-0.22|0.17||||||||0.17|-0.22|
71787123|NCT02785354|143072541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0007|TWO_SIDED|95.0|0.63|0.88|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.88|0.63|0.0007
71787124|NCT02785354|143072541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8341|TWO_SIDED|95.0|0.85|1.14|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.14|0.85|0.8341
71787125|NCT02785354|143072542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0147|TWO_SIDED|95.0|0.65|0.95|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).||0.95|0.65|0.0147
71670527|NCT01836471|142858195|SUPERIORITY_OR_OTHER||least sqares mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.32|0.19||||||||0.19|-0.32|
71670528|NCT01836471|142858195|SUPERIORITY_OR_OTHER||least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
71670529|NCT01836471|142858195|SUPERIORITY_OR_OTHER||least squares mean|-0.17|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.43|0.09||||||||0.09|-0.43|
71670530|NCT01836471|142858196|SUPERIORITY_OR_OTHER|||||||0.793|||||||Mixed Models Analysis|||||||0.7930
71670531|NCT03051100|142858198|SUPERIORITY||Least squares mean difference|-60.5|STANDARD_ERROR_OF_MEAN|3.67|<|0.001|TWO_SIDED|95.0|-68.0|-53.0|||ANCOVA||Triplet therapy minus placebo|||-53.0|-68.0|<0.001
71670532|NCT03051100|142858199|SUPERIORITY||Least squares mean difference|-58.7|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-64.9|-52.6|||ANCOVA||Triplet therapy minus placebo|non-HDL-C||-52.6|-64.9|<0.001
71787126|NCT02785354|143072542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0501|TWO_SIDED|95.0|0.71|1.0|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).||1.00|0.71|0.0501
71787127|NCT02785354|143072543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.67|0.82|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.82|0.67|<0.0001
71670533|NCT03051100|142858199|SUPERIORITY||Least squares mean difference|-46.0|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-51.6|-40.4|||ANCOVA||Triplet therapy minus placebo|TC||-40.4|-51.6|<0.001
71787128|NCT02785354|143072543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.71|0.84|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.84|0.71|<0.0001
71670534|NCT03051100|142858199|SUPERIORITY||Least squares mean difference|-54.1|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-59.7|-48.6|||ANCOVA|||apoB||-48.6|-59.7|<0.001
71670535|NCT03051100|142858199|SUPERIORITY||Least squares mean difference|-36.3|STANDARD_ERROR_OF_MEAN|6.58|<|0.001|TWO_SIDED|95.0|-49.7|-22.8|||ANCOVA|||TG||-22.8|-49.7|<0.001
71670536|NCT03051100|142858199|SUPERIORITY||Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|2.7|=|0.588|TWO_SIDED|95.0|-7.0|4.0|||ANCOVA|||HDL-C||4.0|-7.0|=0.588
71670537|NCT03051100|142858200|SUPERIORITY||Median treatment difference|-41.9|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-60.0|-21.4|||Wilcoxon rank sum test|||||-21.4|-60.0|<0.001
71670538|NCT03051100|142858201|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71670539|NCT03051100|142858202|SUPERIORITY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71670540|NCT05921903|142858244|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.52|||||TWO_SIDED|95.0|2.26|5.48|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 2.||5.48|2.26|
71787129|NCT02785354|143072544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.66|0.76|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.||0.76|0.66|<0.0001
71670541|NCT05921903|142858244|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.28|2.04|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 3.||2.04|1.28|
71670542|NCT05921903|142858245|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.26|||||TWO_SIDED|95.0|0.94|1.69|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-A strain at Visit 4.||1.69|0.94|
71670543|NCT05921903|142858246|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.31|||||TWO_SIDED|95.0|1.01|1.68|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.68|1.01|
71670544|NCT05921903|142858247|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.8|1.3|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-A strain at Visit 4.||1.30|0.80|
71787130|NCT02785354|143072544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001|TWO_SIDED|95.0|0.79|0.89|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.||0.89|0.79|<0.0001
71787131|NCT01752907|143072545|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3479|TWO_SIDED|95.0|-0.4|1.0|||t-test, 2 sided||Treatment difference = bone pain DVD - general education DVD|There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.||1.0|-0.4|0.3479
71787132|NCT00720434|143072586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.||-0.53485|-4.19228|0.0131
71787133|NCT00720434|143072586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
71787134|NCT00720434|143072586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
71670545|NCT05921903|142858249|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|3.37|||||TWO_SIDED|95.0|2.28|4.98|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 2.||4.98|2.28|
71677189|NCT04143594|142873003|SUPERIORITY||Difference in percentage|-2.6||||0.7178|TWO_SIDED|95.0|-18.4|13.2||P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||13.2|-18.4|0.7178
71787135|NCT00720434|143072586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
71787136|NCT00720434|143072586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
71837090|NCT03443323|143180844|SUPERIORITY||||||<|0.06||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||<.06
71670546|NCT05921903|142858249|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.67|||||TWO_SIDED|95.0|1.32|2.13|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/Pooled RSV\_IC) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant (Pooled RSV\_IC group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 3.||2.13|1.32|
71677190|NCT04143594|142873003|SUPERIORITY||Difference in percentage|-7.1||||0.39|TWO_SIDED|95.0|-23.4|9.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.3|-23.4|0.3900
71787137|NCT00720434|143072586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
71787138|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.6|||||TWO_SIDED|95.0|0.1565|0.8785||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.8785|0.1565|
71787139|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.75|||||TWO_SIDED|95.0|0.233|0.969||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9690|0.2330|
71787140|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.625|||||TWO_SIDED|95.0|0.0871|0.9191||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.9191|0.0871|
71787141|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025|||||TWO_SIDED|95.0|-0.4769|0.4336||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
71787142|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125||||||95.0|-0.4024|0.6049||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
71787143|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
71837091|NCT03443323|143180845|SUPERIORITY||||||>|0.0083||||||Statistical significance was evaluated using a threshold p value of .0083, accounting for the estimation of three contrasts of time-by-treatment differences per outcome and two measures per domain (academic performance \[ACES, APS\]).|Mixed Models Analysis|||||||>.0083
71787144|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.3|||||TWO_SIDED|95.0|-0.1836|0.6931||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6931|-0.1836|
71787145|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.375|||||TWO_SIDED|95.0|-0.1732|0.7797||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.7797|-0.1732|
71787146|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
71787147|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.175|||||TWO_SIDED|95.0|-0.2934|0.5917||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5917|-0.2934|
71787148|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
71787149|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.075|||||TWO_SIDED|95.0|-0.5144|0.388||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3880|-0.5144|
71787150|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.1|||||TWO_SIDED|95.0|-0.3728|0.5414||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5414|-0.3728|
71787151|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.25|||||TWO_SIDED|95.0|-0.2913|0.696||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6960|-0.2913|
71787152|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
71837092|NCT03443323|143180846|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
71837093|NCT03443323|143180847|SUPERIORITY||||||>|0.05||||||Statistical significance was evaluated using a threshold p value of .05.|Mixed Models Analysis|||||||>.05
71845532|NCT06307457|143205553|OTHER|||||||0.012|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all age groups.||||0.012
71670547|NCT05921903|142858250|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.97|1.7|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_IC\_2/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). ANCOVA model included the group as fixed effect, and SOT type and baseline log10-transformed titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of vaccine (RSV\_IC\_1 group) and participants that received lung or kidney solid organ transplant and 2 doses of vaccine (RSV\_IC\_2 group) for the RSV-B strain at Visit 4.||1.70|0.97|
71670548|NCT05921903|142858251|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.29|||||TWO_SIDED|95.0|1.0|1.65|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_1) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 1 dose of study intervention (RSV\_IC\_1 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.65|1.00|
71670549|NCT05921903|142858252|OTHER|The statistical analyses performed for the study objectives were descriptive. No success criteria were defined for the statistical analyses conducted in this study.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.8|1.26|||ANCOVA||The comparison is done using the group ratio of adjusted GMT (RSV\_HA/RSV\_IC\_2) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate.|To evaluate the humoral immune response to the RSVPreF3 OA investigational vaccine in participants that received lung or kidney solid organ transplant and 2 doses of study intervention (RSV\_IC\_2 group) and healthy participants (RSV\_HA group) for the RSV-B strain at Visit 4.||1.26|0.80|
71670550|NCT00789854|142858275|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-2.322||||||97.5|-4.6|-0.05||The CI is for comparing add-on quetiapine versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The -0.05 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between add-on quetiapine XR and add-on lithium was shown in the Per Protocol analysis set.||Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium.||-0.05|-4.6|
71670551|NCT00789854|142858275|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha\* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-1.639||||||97.5|-3.24|1.312||The CI is for comparing quetiapine XR mono versus add-on Lithium. The CI = confidence interval was adjusted for multiple comparisons. The 1.312 value should have been +3 or above to fail to reject the null hypothesis.|ANCOVA|Non-inferiority between quetiapine XR mono and add-on lithium was shown in the Per Protocol analysis set.||Quetiapine XR mono was tested versus add-on lithium for non-inferiority. The null hypothesis was that the quetiapine XR mono treatment was non-inferior to add-on lithium.||1.312|-3.24|
71670552|NCT00789854|142858276|SUPERIORITY_OR_OTHER|||||||0.0489||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the add-on quetiapine XR treatment was not different to the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.0489
71787153|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.025||||||95.0|-0.4769|0.4336||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.4336|-0.4769|
71787154|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.125|||||TWO_SIDED|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.6049|-0.4024|
71787155|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.15|||||TWO_SIDED|95.0|-0.5729|0.3149||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.3149|-0.5729|
71787156|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
71787157|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
71787158|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
71787159|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
71845533|NCT06307457|143205554|OTHER|||||||0.061|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.061
71845534|NCT06307457|143205555|OTHER|||||||0.08|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all CCI scores.||||0.080
71845535|NCT06307457|143205556|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.2
71670553|NCT00789854|142858276|SUPERIORITY_OR_OTHER|||||||0.4368||95.0||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the quetiapine XR mono treatment was not different from the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.||||0.4368
71837094|NCT04610892|143180873|SUPERIORITY||Least Square Mean difference|-8.3797||||0.065||90.0|-17.498|0.7387||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||0.7387|-17.4980|0.065
71754357|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.353|TWO_SIDED|95.0|-3.16|1.13||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.13|-3.16|0.353
71754358|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.444|TWO_SIDED|95.0|-1.27|2.88||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||2.88|-1.27|0.444
71754359|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.682|TWO_SIDED|95.0|-2.29|3.48||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||3.48|-2.29|0.682
71754360|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.45|TWO_SIDED|95.0|-4.08|1.82||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.82|-4.08|0.450
71754361|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.218|TWO_SIDED|95.0|-4.49|1.04||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.||1.04|-4.49|0.218
71754362|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.747|TWO_SIDED|95.0|-0.36|0.26||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.26|-0.36|0.747
71837095|NCT04610892|143180873|SUPERIORITY||Least Square Mean difference|2.3915||||0.747||90.0|-3.5338|8.3167||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||8.3167|-3.5338|0.747
71837096|NCT04610892|143180873|SUPERIORITY||Least Square Mean difference|0.5766||||0.563||90.0|-5.4389|6.5921||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.5921|-5.4389|0.563
71670554|NCT01416636|142858308|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71670555|NCT01416636|142858308|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
71670556|NCT01416636|142858309|SUPERIORITY|||||||0.605|||||||Wilcoxon (Mann-Whitney)|||||||0.605
71670557|NCT01416636|142858310|SUPERIORITY|||||||0.307|||||||Wilcoxon (Mann-Whitney)|||||||0.307
71670558|NCT01416636|142858311|SUPERIORITY|||||||0.0019|||||||Chi-squared|||||||0.0019
71754363|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.18|0.45||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.45|-0.18|0.390
71754364|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.228|TWO_SIDED|95.0|-0.12|0.49||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.49|-0.12|0.228
71754365|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.67|-0.18|0.260
71754366|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.141|TWO_SIDED|95.0|-0.76|0.11||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||0.11|-0.76|0.141
71754367|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.007|TWO_SIDED|95.0|-0.98|-0.16||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.||-0.16|-0.98|0.007
71754368|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.409|TWO_SIDED|95.0|-0.61|0.25||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.25|-0.61|0.409
71754369|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.715|TWO_SIDED|95.0|-0.51|0.35||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.35|-0.51|0.715
71787160|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
71891941|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-12.92|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-28.73|2.9|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of the Placebo arm||2.90|-28.73|
71670559|NCT01416636|142858312|SUPERIORITY|||||||0.557|||||||Wilcoxon (Mann-Whitney)|||||||0.557
71670560|NCT01416636|142858313|SUPERIORITY|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71670561|NCT01416636|142858314|SUPERIORITY|||||||1e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00001
71670562|NCT01416636|142858315|SUPERIORITY|||||||3e-06|||||||Wilcoxon (Mann-Whitney)|||||||0.000003
71670563|NCT01416636|142858316|SUPERIORITY|||||||8e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00008
71670564|NCT01416636|142858317|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71670565|NCT01416636|142858318|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71670566|NCT02301169|142858320|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo|Mean Difference (Final Values)|0.3748299||||0.4162|TWO_SIDED|95.0|-0.5479411|1.297601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons|t-test, 2 sided|Welch two sample t-test||||1.2976010|-0.5479411|0.4162
71754370|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.641|TWO_SIDED|95.0|-0.32|0.52||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.32|0.641
71754371|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.767|TWO_SIDED|95.0|-0.64|0.47||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.47|-0.64|0.767
71787161|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
71845536|NCT06307457|143205557|OTHER|||||||0.093|||||||Log Rank|||Statistical data for this outcome measure is provided combined for all number of comorbidities.||||0.093
71837097|NCT04610892|143180873|SUPERIORITY||Least Square Mean difference|1.5204||||0.685||90.0|-3.6657|6.7064||One-sided p-value|ANCOVA|The treatment as a fixed effects and the baseline value and the geographic region and statin therapy intensity at screening as covariates.||||6.7064|-3.6657|0.685
71787162|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
71787163|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
71787164|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
71787165|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
71787166|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|0.0|||||TWO_SIDED|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.5070|-0.5070|
71787167|NCT00720434|143072587|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.2|||||TWO_SIDED|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.||0.2811|-0.6191|
71787168|NCT00720434|143072590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.36357||||0.0131|TWO_SIDED|95.0|-4.19228|-0.53485|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53485|-4.19228|0.0131
71787169|NCT00720434|143072590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4919||||0.0142|TWO_SIDED|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||-0.53760|-4.44619|0.0142
71787170|NCT00720434|143072590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.46325||||0.1368|TWO_SIDED|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.49248|-3.41898|0.1368
71837098|NCT04610892|143180874|SUPERIORITY||Geometric LS mean ratio estimate|1.12||||0.854||90.0|0.94|1.33||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.33|0.94|0.854
71787171|NCT00720434|143072590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.90032||||0.3321|TWO_SIDED|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.96648|-2.76711|0.3321
71787172|NCT00720434|143072590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.02865||||0.2839|TWO_SIDED|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||0.89844|-2.95573|0.2839
71787173|NCT00720434|143072590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.12833||||0.8891|TWO_SIDED|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.||1.99342|-1.73676|0.8891
71787174|NCT02782780|143072591|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.01||||||Test of treatment effect: t(91.6)=3.21|Mixed Models Analysis|||||||<0.01
71787175|NCT02782780|143072591|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTI group: t(92.3)=4.10|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||||||<0.001
71787176|NCT02782780|143072592|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001||||||test of treatment effect: t(94.7)=6.10|Mixed Models Analysis|||||||<0.001
71787177|NCT02782780|143072592|SUPERIORITY||||||<|0.001||||||baseline vs. 6-month follow-up in CBTI group: t(94)=6.67|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTI group.||To compare baseline data to 6-month follow-up data in the CBT-I group, planned contrasts following the mixed models were used.||||<0.001
71787178|NCT02782780|143072593|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(104)=3.40||||||<0.001
71787179|NCT02782780|143072593|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(91.6)=4.37|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
71837099|NCT04610892|143180874|SUPERIORITY||Geometric LS mean ratio estimate|1.06||||0.79||90.0|0.94|1.18||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.18|0.94|0.790
71837100|NCT04610892|143180874|SUPERIORITY||Geometric LS mean ratio estimate|1.0||||0.498||90.0|0.89|1.12||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.12|0.89|0.498
71670567|NCT02301169|142858321|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.|Mean Difference (Final Values)|0.1255102||||0.7887|TWO_SIDED|95.0|-0.8152493|1.0662697||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.0662697|-0.8152493|0.7887
71670568|NCT02301169|142858322|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo|Mean Difference (Final Values)|0.802381||||0.2353|TWO_SIDED|95.0|-0.5457743|2.1505362||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||2.1505362|-0.5457743|0.2353
71787180|NCT02782780|143072594|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|test of treatment effect: t(99.9)=2.09||||||<0.05
71787181|NCT02782780|143072594|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(92.1)=2.56||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||<0.01
71787182|NCT02782780|143072595|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||=|0.991|||||||Mixed Models Analysis|Test of treatment effect: t(110)=-0.41||||||=0.991
71787183|NCT02782780|143072595|SUPERIORITY||||||=|0.41||||||Baseline vs. 6-month follow-up in CBTi group: t(91.8)=0.94|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||=0.41
71787184|NCT02782780|143072596|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses|||||<|0.05|||||||Mixed Models Analysis|Test of treatment effect: t(83.7)=2.51||||||<0.05
71787185|NCT02782780|143072596|SUPERIORITY||||||=|0.49||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(90.9)=0.27||||||=0.49
71787186|NCT02782780|143072597|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.01|||||||Mixed Models Analysis|test of treatment effect: t(105)=4.55||||||<0.01
71787187|NCT02782780|143072597|SUPERIORITY||||||<|0.01||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(91.3)=3.23||||||<0.01
71787188|NCT02782780|143072598|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(91.6)=3.37||||||<0.001
71670569|NCT02301169|142858323|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.|Mean Difference (Final Values)|0.7656429||||0.06204|TWO_SIDED|95.0|-0.0406744|1.5719601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||1.5719601|-0.0406744|0.06204
71787189|NCT02782780|143072598|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: (92.1)=3.64|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
71787190|NCT02782780|143072599|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(99.2)=5.45||||||<0.001
71787191|NCT02782780|143072599|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(93.4)=6.06|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
71787192|NCT02782780|143072600|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|test of treatment effect: t(76.9)=-4.20||||||<0.001
71787193|NCT02782780|143072600|SUPERIORITY||||||<|0.001||||||Baseline vs. 6-month follow-up in CBTi group: t(33.1)=6.52|Mixed Models Analysis|Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.||||||<0.001
71787194|NCT02782780|143072601|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.6)=4.33||||||<0.001
71787195|NCT02782780|143072601|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month follow-up in CBTi group: t(34.4)=4.75||||||<0.001
71787196|NCT02782780|143072602|SUPERIORITY|Linear mixed models with random effects for subjects were used to analyze all available data for the intent-to-treat analysis. Because sex was used as a stratification variable in the randomization procedure, it was not included as a covariate the analyses.|||||<|0.001|||||||Mixed Models Analysis|Test of treatment effect: t(75.1)=3.91||||||<0.001
71787197|NCT02782780|143072602|SUPERIORITY||||||<|0.001||||||Planned contrasts following the mixed models were used to compare baseline data to 6-month follow-up data in the CBTi group.|Mixed Models Analysis|Baseline vs. 6-month in CBTi group: t(34.5)=4.39||||||<0.001
71670570|NCT02301169|142858324|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.|Mean Difference (Final Values)|1.683333||||0.3386|TWO_SIDED|95.0|-1.83119|5.197857||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test||||5.197857|-1.831190|0.3386
71670571|NCT02949973|142858331|OTHER||Percentage|70.0|||||TWO_SIDED|||||||||||||
71670572|NCT02949973|142858332|OTHER||Percentage|40.0|||||TWO_SIDED|||||||||||||
71787198|NCT01571427|143072603|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.35||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.25
71787199|NCT01571427|143072603|EQUIVALENCE|Power calculation was based on the entire sample (CDR=0 and CDR=0.5 combined). Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.25|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.25
71787200|NCT01571427|143072603|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.62||0.85|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: AMONG CDR=0.5 (Mild Cognitive Impairment) group, N=34 .||||0.85
71787201|NCT01571427|143072604|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.92||0.02|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.02
71787202|NCT01571427|143072604|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.28||0.003|TWO_SIDED|||||Statistically significant based on the Bonferroni multiple comparison adjusted P value of P\<0.004.|Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)||||0.003
71787203|NCT01571427|143072604|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|1.14||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: CDR=0.5 (Mild Cognitive Impairment) group, N=34||||0.65
71787204|NCT01571427|143072605|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.33||0.98|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.98
71787205|NCT01571427|143072605|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|1.63||0.96|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: Among CDR 0 (n=49)||||0.96
71787206|NCT01571427|143072605|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.38||0.83|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: Among CDR 0.5 (n=34)||||0.83
71787207|NCT01571427|143072606|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.64||0.68|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.68
71787208|NCT01571427|143072606|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.84||0.69|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.69
71670573|NCT02949973|142858333|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
71670574|NCT02949973|142858334|OTHER||Percentage|20.0|||||TWO_SIDED|||||||||||||
71670575|NCT02949973|142858335|OTHER||Percentage|70.0|||||TWO_SIDED|95.0|34.8|93.3||||||||93.3|34.8|
71670576|NCT02949973|142858336|OTHER||Percentage|50.0|||||TWO_SIDED|95.0|15.7|84.3||||||||84.3|15.7|
71787209|NCT01571427|143072606|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.02||0.86|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.86
71787210|NCT01571427|143072607|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.43||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.92
71787211|NCT01571427|143072607|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.61||0.92|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.92
71787212|NCT01571427|143072607|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.62||0.94|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.94
71787213|NCT01571427|143072608|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.84||0.46|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.46
71787214|NCT01571427|143072608|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|2.08||0.61|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.61
71787215|NCT01571427|143072608|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|6.42||0.8|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.80
71787216|NCT01571427|143072609|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|8.88||0.72|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.72
71787217|NCT01571427|143072609|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|11.1||0.84|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.84
71787218|NCT01571427|143072609|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|12.39|STANDARD_ERROR_OF_MEAN|14.4||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
71787219|NCT01571427|143072610|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.91||0.38|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.38
71837101|NCT04610892|143180874|SUPERIORITY||Geometric LS mean ratio estimate|1.03||||0.678||90.0|0.93|1.13||One sided p-value|Mixed model with repeated measurements|The model was adjusted for the baseline value and the stratification factors (geographic region and statin therapy intensity at screening).||||1.13|0.93|0.678
71837102|NCT04610892|143180875|SUPERIORITY||Least Squares mean difference|-1.44||||0.99||90.0|-2.44|-0.43||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.43|-2.44|0.990
71837103|NCT04610892|143180875|SUPERIORITY||Least Squares mean difference|-0.21||||0.697||90.0|-0.87|0.45||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.45|-0.87|0.697
71670577|NCT01422213|142858337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.22|0.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the mixed model for repeated measurements (MMRM) with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.50|0.22|<0.0001
71670578|NCT01422213|142858337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.19|0.47||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.||0.47|0.19|<0.0001
71670579|NCT01422213|142858338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|2.5|5.9||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.90|2.50|<0.0001
71670580|NCT01422213|142858338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|2.57|5.94||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||5.94|2.57|<0.0001
71670581|NCT01422213|142858339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|0.46||0.0287|TWO_SIDED|95.0|0.11|1.93||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.93|0.11|0.0287
71670582|NCT01422213|142858339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.46||0.1988|TWO_SIDED|95.0|-0.31|1.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.50|-0.31|0.1988
71837104|NCT04610892|143180875|SUPERIORITY||Least Squares mean difference|-0.42||||0.849||90.0|-1.08|0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.25|-1.08|0.849
71837105|NCT04610892|143180875|SUPERIORITY||Least Squares mean difference|-0.31||||0.811||90.0|-0.89|0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.27|-0.89|0.811
71837106|NCT04610892|143180876|SUPERIORITY||Least Squares mean difference|-3.5||||0.972||90.0|-6.49|-0.5||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.50|-6.49|0.972
71837107|NCT04610892|143180876|SUPERIORITY||Least Squares mean difference|-1.1||||0.777||90.0|-3.49|1.3||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.30|-3.49|0.777
71837108|NCT04610892|143180876|SUPERIORITY||Least Squares mean difference|-0.32||||0.596||90.0|-2.54|1.89||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.89|-2.54|0.596
71837109|NCT04610892|143180876|SUPERIORITY||Least Squares mean difference|-0.63||||0.698||90.0|-2.64|1.38||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||1.38|-2.64|0.698
71837110|NCT04610892|143180877|SUPERIORITY||Least Squares mean difference|-1.29||||0.981||90.0|-2.32|-0.27||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.27|-2.32|0.981
71837111|NCT04610892|143180877|SUPERIORITY||Least Squares mean difference|-0.8||||0.974||90.0|-1.47|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-1.47|0.974
71837112|NCT04610892|143180877|SUPERIORITY||Least Squares mean difference|-0.86||||0.983||90.0|-1.53|-0.2||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.20|-1.53|0.983
71837113|NCT04610892|143180877|SUPERIORITY||Least Squares mean difference|-0.83||||0.99||90.0|-1.42|-0.25||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.25|-1.42|0.990
71837114|NCT04610892|143180878|SUPERIORITY||Least Squares mean difference|-2.14||||0.959||90.0|-4.16|-0.12||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.12|-4.16|0.959
71837115|NCT04610892|143180878|SUPERIORITY||Least Squares mean difference|-2.92||||0.998||90.0|-4.53|-1.31||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-1.31|-4.53|0.998
71837116|NCT04610892|143180878|SUPERIORITY||Least Squares mean difference|-1.35||||0.939||90.0|-2.79|0.09||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||0.09|-2.79|0.939
71837117|NCT04610892|143180878|SUPERIORITY||Least Squares mean difference|-1.94||||0.991||90.0|-3.27|-0.62||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||-0.62|-3.27|0.991
71837118|NCT04610892|143180879|SUPERIORITY||Least Squares mean difference|-16.137||||0.077||90.0|-34.7829|2.5089||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.5089|-34.7829|0.077
71837119|NCT04610892|143180879|SUPERIORITY||Least Squares mean difference|-0.5927||||0.468||90.0|-12.7267|11.5413||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||11.5413|-12.7267|0.468
71837120|NCT04610892|143180879|SUPERIORITY||Least Squares mean difference|-0.1767||||0.491||90.0|-12.4678|12.1144||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||12.1144|-12.4678|0.491
71670583|NCT01422213|142858340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.24||0.0033|TWO_SIDED|95.0|0.24|1.19||Since the p-value for RAVLT acquisition for 10 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.19|0.24|0.0033
71670584|NCT01422213|142858340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.24||0.0073|TWO_SIDED|95.0|0.17|1.12||Since the p-value for RAVLT acquisition for 20 mg was \>0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||1.12|0.17|0.0073
71670585|NCT01422213|142858341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.37||0.0061|TWO_SIDED|95.0|-6.45|-1.08||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.08|-6.45|0.0061
71670586|NCT01422213|142858341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|1.35||0.0052|TWO_SIDED|95.0|-6.46|-1.14||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.14|-6.46|0.0052
71670587|NCT01422213|142858342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.57|STANDARD_ERROR_OF_MEAN|2.73||0.0058|TWO_SIDED|95.0|-12.93|-2.2||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.20|-12.93|0.0058
71837121|NCT04610892|143180879|SUPERIORITY||Least Squares mean difference|-0.393||||0.476||90.0|-11.0022|10.2162||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||10.2162|-11.0022|0.476
71837122|NCT04610892|143180880|SUPERIORITY||Least Squares mean difference|-4.3435||||0.136||90.0|-10.8637|2.1768||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.1768|-10.8637|0.136
71837123|NCT04610892|143180880|SUPERIORITY||Least Squares mean difference|-1.2369||||0.316||90.0|-5.4796|3.0059||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.0059|-5.4796|0.316
71837124|NCT04610892|143180880|SUPERIORITY||Least Squares mean difference|-0.7015||||0.394||90.0|-5.0096|3.6065||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||3.6065|-5.0096|0.394
71837125|NCT04610892|143180880|SUPERIORITY||Least Squares mean difference|-0.9799||||0.332||90.0|-4.6927|2.7329||One sided p-value|ANCOVA|The model was adjusted for the baseline value and stratification factors (geographic region and statin therapy intensity at screening).||||2.7329|-4.6927|0.332
71837126|NCT05520190|143180890|SUPERIORITY||Standardized Response Mean|-0.47|||||TWO_SIDED||||||||Baseline Attitude score - 1-month Attitude score / SD of average change|||||
71837127|NCT05520190|143180891|SUPERIORITY||Standardized Response Mean|-0.23|||||TWO_SIDED||||||||Baseline Norm score - 1-month Norm score / SD of average change|||||
71837128|NCT05520190|143180892|SUPERIORITY||Standardized Response Mean|-0.03|||||TWO_SIDED||||||||Baseline Perceived Behavioral Control score - 1-month Perceived Behavioral Control score / SD of average change|||||
71837129|NCT05520190|143180893|SUPERIORITY||Standardized Response Mean|-0.16|||||TWO_SIDED||||||||Baseline Intention score - 1-month Intention score / SD of average change|||||
71837130|NCT05520190|143180894|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinks per day - 1-month drinks per day / avg change in drinks per day|||||
71837131|NCT05520190|143180895|SUPERIORITY||Standardized Response Mean|0.35|||||TWO_SIDED||||||||Baseline drinking days - 1-month drinking days / SD of avg change in drinking days|||||
71845537|NCT06307457|143205558|OTHER||||||>|0.9|||||||Log Rank|||Statistical data for participants with cardiac disease comorbidity reported.||||>0.9
71670588|NCT01422213|142858342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.01|STANDARD_ERROR_OF_MEAN|2.7||0.0009|TWO_SIDED|95.0|-14.32|-3.7||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-3.70|-14.32|0.0009
71670589|NCT01422213|142858343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.28||0.0018|TWO_SIDED|95.0|-6.5|-1.49||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.49|-6.50|0.0018
71670590|NCT01422213|142858343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.26||0.0005|TWO_SIDED|95.0|-6.93|-1.97||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-1.97|-6.93|0.0005
71670591|NCT01422213|142858344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-10.76|-2.74||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.74|-10.76|0.0010
71670592|NCT01422213|142858344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.52|STANDARD_ERROR_OF_MEAN|2.02||0.0013|TWO_SIDED|95.0|-10.49|-2.54||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.54|-10.49|0.0013
71670593|NCT01422213|142858345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|-0.07|-0.02||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.02|-0.07|0.0002
71670594|NCT01422213|142858345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0157|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0157
71670595|NCT01422213|142858346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.009||0.0005|TWO_SIDED|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.01|-0.05|0.0005
71670596|NCT01422213|142858346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.009||0.3549|TWO_SIDED|95.0|-0.03|0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||0.01|-0.03|0.3549
71670597|NCT01422213|142858347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.45|-2.96||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-2.96|-6.45|<0.0001
71670598|NCT01422213|142858347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-8.43|-4.98||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-4.98|-8.43|<0.0001
71670599|NCT01422213|142858348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.88|-0.42||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.42|-0.88|<0.0001
71670600|NCT01422213|142858348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.08|-0.62||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.||-0.62|-1.08|<0.0001
71670601|NCT01422213|142858349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.4||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.40|-0.81|<0.0001
71787220|NCT01571427|143072610|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.31||0.39|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.39
71837132|NCT05520190|143180896|SUPERIORITY||Standardized Response Mean|0.3|||||TWO_SIDED||||||||Baseline binge drinking days - 1-month binge drinking days / avg change in binge drinking days|||||
71754372|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.881|TWO_SIDED|95.0|-0.61|0.52||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.52|-0.61|0.881
71754373|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.885|TWO_SIDED|95.0|-0.51|0.59||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.||0.59|-0.51|0.885
71754374|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.325|TWO_SIDED|95.0|-0.96|0.32||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.32|-0.96|0.325
71754375|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.798|TWO_SIDED|95.0|-0.73|0.56||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.56|-0.73|0.798
71754376|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.461|TWO_SIDED|95.0|-0.39|0.87||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.87|-0.39|0.461
71754377|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.67|TWO_SIDED|95.0|-1.02|0.66||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.66|-1.02|0.670
71754378|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.243|TWO_SIDED|95.0|-1.37|0.35||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.35|-1.37|0.243
71754379|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.423|TWO_SIDED|95.0|-1.14|0.48||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.||0.48|-1.14|0.423
71787221|NCT01571427|143072610|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.26||0.59|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.59
71813136|NCT03720938|143128570|SUPERIORITY|||||||0.002||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.002
71787222|NCT01571427|143072611|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.03|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.03
71787223|NCT01571427|143072611|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.24
71787224|NCT01571427|143072611|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.04
71787225|NCT01571427|143072612|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.65|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.65
71787226|NCT01571427|143072612|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.64
71787227|NCT01571427|143072612|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.42
71787228|NCT01571427|143072613|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.45||0.45|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.45
71787229|NCT01571427|143072613|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.05||0.93|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.93
71787230|NCT01571427|143072613|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.40
71787231|NCT01571427|143072614|EQUIVALENCE|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|||||0.30
71837133|NCT05520190|143180897|SUPERIORITY||Standardized Response Mean|1.23|||||TWO_SIDED||||||||Baseline depression - 1-month depression / SD of avg change in depression|||||
71837134|NCT05520190|143180898|SUPERIORITY||Standardized Response Mean|1.06|||||TWO_SIDED||||||||Baseline anxiety - 1-month anxiety / SD avg change in anxiety|||||
71837135|NCT05520190|143180899|SUPERIORITY||Standardized Response Mean|0.9|||||TWO_SIDED||||||||Baseline PTSD - 1-month PTSd / SD avg change in PTSD|||||
71837136|NCT05520190|143180900|SUPERIORITY||Standardized Response Mean|0.6|||||TWO_SIDED||||||||Baseline insomnia - 1-month insomnia / SD avg change in insomnia|||||
71837137|NCT05520190|143180901|SUPERIORITY||Standardized Response Mean|0.58|||||TWO_SIDED||||||||Baseline Alcohol Screen - 1-month Alcohol Screen / SD avg change|||||
71837138|NCT05520190|143180902|SUPERIORITY||Standardized Response Mean|-0.39|||||TWO_SIDED||||||||Baseline behavioral beliefs - 1-month behavioral beliefs / avg change in behavioral beliefs|||||
71837139|NCT05520190|143180903|SUPERIORITY||Standardized Response Mean|-0.62|||||TWO_SIDED||||||||Baseline normative beliefs - 1-month normative beliefs / SD avg change in normative beliefs|||||
71670602|NCT01422213|142858349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.06|-0.65||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.||-0.65|-1.06|<0.0001
71670603|NCT01422213|142858350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0002|TWO_SIDED|95.0|1.44|3.33||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.33|1.44|0.0002
71670604|NCT01422213|142858350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.43|||<|0.0001|TWO_SIDED|95.0|2.26|5.21||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.21|2.26|<0.0001
71670605|NCT01422213|142858351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.003|TWO_SIDED|95.0|1.29|3.41||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||3.41|1.29|0.0030
71670606|NCT01422213|142858351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|1.95|5.03||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic|||||5.03|1.95|<0.0001
71670607|NCT01422213|142858352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.059||0.0393|TWO_SIDED|95.0|0.01|0.24||No adjustment for multiplicity was made.|ANCOVA|||||0.24|0.01|0.0393
71670608|NCT01422213|142858353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.068||0.0007|TWO_SIDED|95.0|0.1|0.36||No adjustment for multiplicity was made.|ANCOVA|||||0.36|0.10|0.0007
71754380|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.333|TWO_SIDED|95.0|-1.04|0.35||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.35|-1.04|0.333
71891942|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.18|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-11.69|22.05|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 10 mg arm||22.05|-11.69|
71787232|NCT01571427|143072614|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.75|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)||||0.75
71787233|NCT01571427|143072614|EQUIVALENCE|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.15||0.12|TWO_SIDED||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)||||0.12
71813137|NCT03720938|143128570|SUPERIORITY|||||||0.00238||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite's degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.||||0.00238
71891943|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.11|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|-13.13|19.36|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 50 mg arm||19.36|-13.13|
71891944|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.39|STANDARD_DEVIATION|14.47|||TWO_SIDED|95.0|4.47|34.3|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment\*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 125 mg arm||34.30|4.47|
71891945|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 1 Diabetes, Day 1|Intercept estimate was 125.45 and between participant standard deviation was 21.63|-0.129|-0.320|
71891946|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078|||||TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|||Type 1 Diabetes, Day 28|Intercept estimate was 125.45 and between participant standard deviation was 21.63|0.016|-0.171|
71670609|NCT01422213|142858353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.068||0.0246|TWO_SIDED|95.0|0.02|0.29||No adjustment for multiplicity was made.|ANCOVA|||||0.29|0.02|0.0246
71670610|NCT03197389|142858355|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|||||||||||||
71670611|NCT04129125|142858356|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|83.4|||<|0.0001|TWO_SIDED|95.0|78.0|88.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||88|78|<0.0001
71670612|NCT04129125|142858357|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|1.9|||||TWO_SIDED|95.0|0.6|4.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||4.4|0.6|
71813138|NCT03720938|143128571|SUPERIORITY|||||||0.194||||||Tested the significance of gender between genders|Wilcoxon (Mann-Whitney)|||"Enjoyment scale of physical activity sports in intervention group between male and female genders"||||0.194
71891947|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.225|||||TWO_SIDED|95.0|-0.32|-0.129|||Mixed Models Analysis|||Type 2 Diabetes, Day 1|Intercept estimate was 113.23 and between participant standard deviation was 21.63|-0.129|-0.320|
71670613|NCT04129125|142858358|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|84.0||||0.0001|TWO_SIDED|95.0|78.0|89.0||The p-value a priori threshold for statistical significance was \<0.025|Fisher Exact|||The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%||89|78|0.0001
71787234|NCT03510884|143072615|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-43.3|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-56.0|-30.7||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per interactive voice response system (IVRS), time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.7|-56.0|<0.0001
71787235|NCT03510884|143072615|SUPERIORITY|Bonferroni adjustment was applied to handle multiplicity for the comparison of each alirocumab dosing regimen group versus its placebo group for the primary efficacy endpoint.|LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.0001|TWO_SIDED|97.5|-46.4|-21.2||The threshold for statistical significance was 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.2|-46.4|<0.0001
71787236|NCT03510884|143072616|SUPERIORITY|Hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-45.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-56.3|-34.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-34.7|-56.3|<0.0001
71787237|NCT03510884|143072616|SUPERIORITY|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported and independently for each dosing regimen. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Statistical significance of the primary endpoint was required before testing the first secondary endpoint for each dosing regimen independently.|LS mean difference|-41.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-52.7|-30.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline LDL-C value and Baseline value by time-point interaction. Comparison was performed using an appropriate contrast.||-30.2|-52.7|<0.0001
71787238|NCT03510884|143072617|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED|97.5|-47.5|-28.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-28.2|-47.5|<0.0001
71787239|NCT03510884|143072617|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.7|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|97.5|-42.0|-19.4||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.4|-42.0|<0.0001
71813139|NCT03720938|143128572|SUPERIORITY|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the Active video game group for the variable of enjoyment from sports category.||||0.809
71813140|NCT03720938|143128573|SUPERIORITY|||||||0.843|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from balance category.||||0.843
71813141|NCT03720938|143128574|SUPERIORITY|||||||0.247|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from aerobic category.||||0.247
71787240|NCT03510884|143072618|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-40.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001|TWO_SIDED|97.5|-52.2|-29.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.1|-52.2|<0.0001
71787241|NCT03510884|143072618|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-31.9|STANDARD_ERROR_OF_MEAN|5.3|<|0.0001|TWO_SIDED|97.5|-44.1|-19.7||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-19.7|-44.1|<0.0001
71787242|NCT03510884|143072619|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-30.8|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|97.5|-39.8|-21.9||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-21.9|-39.8|<0.0001
71787243|NCT03510884|143072619|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|97.5|-33.5|-13.1||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-13.1|-33.5|<0.0001
71787244|NCT03510884|143072620|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-38.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|97.5|-48.2|-29.6||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-29.6|-48.2|<0.0001
71787245|NCT03510884|143072620|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED|97.5|-42.8|-22.7|||MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Apo B value and Baseline Apo B value by time-point interaction. Comparison was performed using an appropriate contrast.||-22.7|-42.8|<0.0001
71787246|NCT03510884|143072621|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001|TWO_SIDED|97.5|-53.8|-31.8||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Non-HDL-C value and Baseline Non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-31.8|-53.8|<0.0001
71787247|NCT03510884|143072621|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|97.5|-47.9|-27.0||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline non-HDL-C value and Baseline non-HDL-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-27.0|-47.9|<0.0001
71670614|NCT04129125|142858359|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|0.9|||||TWO_SIDED|95.0|0.1|3.4||||||The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%||3.4|0.1|
71787248|NCT03510884|143072622|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|97.5|-41.3|-24.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q2W versus Placebo Q2W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-24.2|-41.3|<0.0001
71787249|NCT03510884|143072622|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|97.5|-35.6|-20.2||Threshold for significance at 0.025 level.|MMRM||Alirocumab Q4W versus Placebo Q4W|The MMRM model included the fixed categorical effects of treatment group (alirocumab, placebo), randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS, time point, treatment-by-time point interaction, and BW strata-by-time point interaction, as well as the continuous fixed covariates of Baseline Total-C value and Baseline Total-C value by time-point interaction. Comparison was performed using an appropriate contrast.||-20.2|-35.6|<0.0001
71787250|NCT03510884|143072623|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|77.6|||=|0.0001|TWO_SIDED|97.5|6.3|960.0||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||960.0|6.3|=0.0001
71787251|NCT03510884|143072623|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|14.9|||<|0.0001|TWO_SIDED|97.5|3.2|69.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. Logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||69.8|3.2|<0.0001
71837140|NCT05520190|143180904|SUPERIORITY||Standardized Response Mean|-0.83|||||TWO_SIDED||||||||Baseline control beliefs - 1-month control beliefs / SD avg change in control beliefs|||||
71837141|NCT03683719|143180905|SUPERIORITY||||||<|0.001||||||"P-values were adjusted for multiple comparisons. Models with an adjusted p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: IGA-CHE TS = Treatment + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||The primary endpoint was evaluated by determining if there was a dose-response relationship between the IGA-CHE response rate at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve.||||<0.001
71837142|NCT03683719|143180905|SUPERIORITY||Risk Difference (RD)|13.29|||>|0.05|TWO_SIDED|95.0|0.34|26.24||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||26.24|0.34|>0.05
71845538|NCT06307457|143205558|OTHER|||||||0.9|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.9
71845539|NCT06307457|143205558|OTHER|||||||0.4|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.4
71845540|NCT06307457|143205559|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants cardiac disease comorbidity reported.||||0.7
71845541|NCT06307457|143205559|OTHER|||||||0.3|||||||Log Rank|||Statistical data for participants with vascular disease comorbidity reported.||||0.3
71670615|NCT04129125|142858368|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.7|||||TWO_SIDED|95.0|8.5|16.7|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the all-cause mortality endpoint was for the observed rate to be ≤20.3%||16.7|8.5|
71845542|NCT06307457|143205559|OTHER|||||||0.7|||||||Log Rank|||Statistical data for participants with metabolic disease comorbidity reported.||||0.7
71845543|NCT06307457|143205560|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
71845544|NCT06307457|143205561|OTHER|||||||0.005|||||||Log Rank|||Statistical data for this outcome measure is provided combined for visceral disease status.||||0.005
71845545|NCT06307457|143205562|OTHER|||||||0.14|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.14
71845546|NCT06307457|143205563|OTHER|||||||0.2|||||||Log Rank|||Statistical data for this outcome measure is provided combined for bone disease status.||||0.2
71845547|NCT06307457|143205564|OTHER|||||||0.047|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.047
71754381|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.334|TWO_SIDED|95.0|-1.05|0.36||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.36|-1.05|0.334
71787252|NCT03510884|143072624|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|26.5|||<|0.0001|TWO_SIDED|97.5|4.0|174.8||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||174.8|4.0|<0.0001
71787253|NCT03510884|143072624|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|40.9|||<|0.0001|TWO_SIDED|97.5|5.7|290.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||290.9|5.7|<0.0001
71670616|NCT04129125|142858379|OTHER|The study sample size of 260 subjects was selected to have at least 90 percent power for primary safety and efficacy endpoints and all-cause mortality|Event rate|12.3|||||TWO_SIDED|95.0|8.1|17.2|||||Event and CI estimated using Kaplan-Meier method|The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤20.3%||17.2|8.1|
71670617|NCT03832686|142858556|OTHER|||||||0.86||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.86
71670618|NCT03832686|142858557|OTHER|||||||0.69||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.69
71670619|NCT03832686|142858558|OTHER|||||||0.47||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Eating in Public Score||||0.47
71670620|NCT03832686|142858558|OTHER|||||||0.73||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of Normalcy of Diet score||||0.73
71670621|NCT03832686|142858559|OTHER|||||||0.65||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Oral score||||0.65
71754382|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-0.69|0.68||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.68|-0.69|0.990
71754383|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.665|TWO_SIDED|95.0|-0.7|1.09||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||1.09|-0.70|0.665
71754384|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.1|0.74||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.74|-1.10|0.700
71754385|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.386|TWO_SIDED|95.0|-1.23|0.48||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.||0.48|-1.23|0.386
71754386|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.12|TWO_SIDED|95.0|-1.27|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.27|0.120
71754387|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.119|TWO_SIDED|95.0|-1.29|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.15|-1.29|0.119
71754388|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.71|0.69||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.69|-0.71|0.976
71754389|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17||||0.026|TWO_SIDED|95.0|0.14|2.2||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||2.20|0.14|0.026
71813142|NCT03720938|143128575|SUPERIORITY|||||||0.543|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from training category.||||0.543
71813143|NCT00499863|143128576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The null hypothesis was that there is no difference between MTS and placebo.||||< 0.001
71813144|NCT00499863|143128577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71813145|NCT00499863|143128578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71813146|NCT00499863|143128579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71813147|NCT00499863|143128580|SUPERIORITY_OR_OTHER|||||||0.288||95.0|||||ANCOVA|||||||0.288
71813148|NCT00571701|143128588|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71813149|NCT00571701|143128589|SUPERIORITY_OR_OTHER|||||||0.43|||||||Fisher Exact|||||||0.43
71670622|NCT03832686|142858559|OTHER|||||||0.24||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||Comparison of MBSImP Pharyngeal score||||0.24
71670623|NCT03832686|142858560|OTHER|||||||0.53||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.53
71670624|NCT03832686|142858561|OTHER|||||||0.5||||||A p-value of \<0.05 would be considered statistically significant.|Logistic Regression|||||||0.50
71670625|NCT04581824|142858622|OTHER||Difference in Response Rate|9.32|||||TWO_SIDED|80.0|1.46|17.18|||||Mantel and Haenszel method with Sato's variance estimator was used for between arms comparison and was stratified by PD-L1 status and smoking status based on the strata data collected in interactive response technology (IRT) at randomization|||17.18|1.46|
71754390|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36||||0.497|TWO_SIDED|95.0|-0.69|1.42||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||1.42|-0.69|0.497
71754391|NCT00385671|143011909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.112|TWO_SIDED|95.0|-1.8|0.19||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.||0.19|-1.80|0.112
71754392|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.486
71754393|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.983
71754394|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.411
71754395|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.554
71787254|NCT03510884|143072625|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|52.7|||=|0.0011|TWO_SIDED|97.5|3.5|804.3||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q2W versus Placebo Q2W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||804.3|3.5|=0.0011
71813150|NCT00571701|143128590|SUPERIORITY_OR_OTHER||||||>|0.3||||||Adjusted for multiple comparisons|Fisher Exact|||||||>0.3
71813151|NCT00571701|143128591|SUPERIORITY_OR_OTHER|||||||1||||||Adjusted for multiple comparisons|Fisher Exact|||||||1.00
71670626|NCT04796909|142858623|SUPERIORITY|||||||0.05|||||||Repeated-measures ANCOVA|||||||0.05
71813152|NCT00571701|143128592|SUPERIORITY_OR_OTHER||||||>|0.5||||||Adjusted for multiple comparisons|Fisher Exact|||||||> 0.5
71670627|NCT04796909|142858624|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71670628|NCT04796909|142858625|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71670629|NCT04796909|142858626|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71670630|NCT04796909|142858627|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71670631|NCT04796909|142858628|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71670632|NCT04796909|142858629|SUPERIORITY|||||||0.05|||||||Repeated-Measures ANCOVA|||||||0.05
71670633|NCT04796909|142858630|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71670634|NCT04796909|142858631|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71670635|NCT04796909|142858632|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71670636|NCT04162847|142858668|SUPERIORITY||Odds Ratio (OR)|0.98||||0.76|TWO_SIDED|95.0|0.88|1.1|||Regression, Logistic|||Baseline||1.10|.88|.76
71670637|NCT04162847|142858668|SUPERIORITY||Odds Ratio (OR)|0.84||||0.001|TWO_SIDED|95.0|0.76|0.93|||Regression, Logistic|||6 week follow-up||.93|.76|.001
71670638|NCT04162847|142858668|SUPERIORITY||Odds Ratio (OR)|0.82||||0|TWO_SIDED|95.0|0.74|0.9|||Regression, Logistic|||6 month follow-up||.90|.74|.000
71837143|NCT03683719|143180905|SUPERIORITY||Risk Difference (RD)|-0.03|||>|0.05|TWO_SIDED|95.0|-10.44|10.39||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||10.39|-10.44|>0.05
71837144|NCT03683719|143180905|SUPERIORITY||Risk Difference (RD)|28.22|||<|0.001|TWO_SIDED|95.0|13.8|42.64||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||42.64|13.8|<0.001
71837145|NCT03683719|143180905|SUPERIORITY||Risk Difference (RD)|29.61|||<|0.001|TWO_SIDED|95.0|14.56|44.67||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue medication before Week 16 were considered missing and imputed as non-responders (as were any other missing data).|Cochran-Mantel-Haenszel|||The difference in response rates between the active delgocitinib cream doses and delgocitinib cream vehicle was analysed separately for each of the active dose groups using the Cochran-Mantel-Haenszel test stratified by region and disease severity (baseline IGA-CHE score). The null hypothesis of no difference in response rates between the delgocitinib cream active doses and delgocitinib cream vehicle was tested against the 2-sided alternative that there is a difference.||44.67|14.56|<0.001
71837146|NCT03683719|143180906|SUPERIORITY||||||<|0.0001||||||"P-values were adjusted for multiple comparisons. Models with an adj. p-value \<0.025 were statistically sign. different from a flat dose-response model. Model: Change = Treatment + Baseline + Region + Baseline IGA-CHE.~Model selected: Emax model"|Multiple contrast test|||"The secondary endpoint Change from baseline to Week 16 in HECSI score was evaluated by determining if there was a dose-response relationship between the change from baseline in HECSI score at Week 16 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. Several candidate parametric models were assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve."||||<0.0001
71845548|NCT06307457|143205565|OTHER|||||||0.041|||||||Log Rank|||Statistical data for this outcome measure is provided combined for endocrine status.||||0.041
71845549|NCT04401267|143205566|SUPERIORITY|||||||0.7139|||||||Fisher Exact|||||||0.7139
71845550|NCT02962284|143205581|SUPERIORITY||||||>|0.1|||||||ANCOVA|||||||>0.1
71670639|NCT04162847|142858668|SUPERIORITY||Odds Ratio (OR)|0.86||||0.002|TWO_SIDED|95.0|0.77|0.95|||Regression, Logistic|||2 year||.95|.77|.002
71670640|NCT04162847|142858669|SUPERIORITY||Odds Ratio (OR)|6.7||||0|TWO_SIDED|95.0|5.98|7.5|||Chi-squared|||A comparison of service uptake between the intervention and control groups over the 6-month follow-up period.||7.50|5.98|.000
71845551|NCT00357994|143205606|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.91|STANDARD_ERROR_OF_MEAN|0.57||0.0015|TWO_SIDED|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA|||||-0.76|-3.05|0.0015
71845552|NCT00357994|143205607|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.86|STANDARD_ERROR_OF_MEAN|0.65||0.0059|TWO_SIDED|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||3.17|0.56|0.0059
71845553|NCT00357994|143205608|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-7.0|STANDARD_ERROR_OF_MEAN|2.8||0.0155|TWO_SIDED|95.0|-12.6|-1.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-1.4|-12.6|0.0155
71845554|NCT00357994|143205609|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0258|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.1|-1.4|0.0258
71845555|NCT00357994|143205610|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.0|STANDARD_ERROR_OF_MEAN|1.1||0.0086|TWO_SIDED|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||-0.8|-5.3|0.0086
71845556|NCT00357994|143205611|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|1.4|STANDARD_ERROR_OF_MEAN|2.1||0.502|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||5.6|-2.8|0.5020
71670641|NCT04162847|142858669|SUPERIORITY||Odds Ratio (OR)|1.83||||0|TWO_SIDED|95.0|1.64|2.04|||Chi-squared|||A secondary analysis using the same criterion for the intervention group (access to the digital intervention during the 6-month follow-up) but expanding the control group definition to include individuals who reported having psychotherapy or starting a new medication at any point during the full 2-year follow-up period.||2.04|1.64|.000
71670642|NCT04162847|142858670|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 week||||.000
71670643|NCT04162847|142858670|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 6 months||||.000
71670644|NCT04162847|142858670|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PHQ-9 2 year||||.02
71670645|NCT04162847|142858670|SUPERIORITY|||||||0.002|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 week||||.002
71670646|NCT04162847|142858670|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 6 month||||.80
71670647|NCT04162847|142858670|SUPERIORITY|||||||0.51|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||GADQ-IV 2 year||||.51
71670648|NCT04162847|142858670|SUPERIORITY|||||||0.004|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 week||||.004
71670649|NCT04162847|142858670|SUPERIORITY|||||||0.02|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 6 month||||.02
71670650|NCT04162847|142858670|SUPERIORITY|||||||0.09|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||SPDQ 2 year||||.09
71670651|NCT04162847|142858670|SUPERIORITY|||||||0.66|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 week||||.66
71670652|NCT04162847|142858670|SUPERIORITY|||||||0.85|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 6 month||||.85
71670653|NCT04162847|142858670|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||PDSR 2 year||||.97
71787255|NCT03510884|143072625|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|43.1|||=|0.0006|TWO_SIDED|97.5|3.7|498.6||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||498.6|3.7|=0.0006
71813153|NCT00571701|143128593|SUPERIORITY_OR_OTHER||||||>|0.56|||||||t-test, 2 sided|||||||>0.56
71754396|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.128
71891948|NCT01262898|143305440|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.078||||||95.0|-0.171|0.016|||Mixed Models Analysis|||Type 2 Diabetes, Day 28|Intercept estimate was 113.23 and between participant standard deviation was 21.63|0.016|-0.171|
71670654|NCT04162847|142858670|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 week||||.000
71670655|NCT04162847|142858670|SUPERIORITY|||||||0|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 6 month||||.000
71670656|NCT04162847|142858670|SUPERIORITY|||||||0.54|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||EDE-Q Global 2 year||||.54
71670657|NCT04162847|142858671|SUPERIORITY|||||||0.48|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 6 months||||.48
71670658|NCT04162847|142858671|SUPERIORITY|||||||0.04|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Mental component summary 2 years||||.04
71670659|NCT04162847|142858671|SUPERIORITY|||||||0.97|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 6 months||||.97
71670660|NCT04162847|142858671|SUPERIORITY|||||||0.8|||||||multilevel modeling methods|Multilevel modeling was used to examine differences in changes in each outcome measure between the two conditions.||Physical component summary 2 years||||.80
71670661|NCT05022667|142858678|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71670662|NCT05022667|142858679|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
71670663|NCT05022667|142858680|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.2
71670664|NCT05022667|142858681|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71670665|NCT05022667|142858682|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
71670666|NCT05022667|142858684|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||.3
71670667|NCT00813150|142858688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||Null Hypothesis: The (median) time to progression is equal in both treatment groups||1.19|0.43|0.196
71670668|NCT00813150|142858689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.196|TWO_SIDED|95.0|0.43|1.19|||Regression, Cox|||||1.19|0.43|0.196
71787256|NCT03510884|143072626|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|41.3|||<|0.0001|TWO_SIDED|97.5|6.6||The percentage of participants reaching LDL-C level lower than 110 mg/dL was 0% in the placebo arm, as a result it was possible to derive the estimated odds-ratio, but the estimated confidence interval (CI) was very wide, with the upper limit estimated to Infinity, therefore upper limit of 97.5% CI was not available to report.|Threshold for significance at 0.025 level.|Exact conditional logistic regression||Alirocumab Q2W versus Placebo Q2W: Odds ratios and confidence intervals estimated from exact conditional logistic regression model.|The LOCF approach followed by exact conditional logistic regression model. The exact conditional logistic regression model stratified by randomization factors (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the quartiles of the Baseline LDL-C value.|||6.6|<0.0001
71813154|NCT03815019|143128630|SUPERIORITY||Odds Ratio, log|7.2218|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the megestrol group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
71813155|NCT03815019|143128630|SUPERIORITY||Odds Ratio, log|9.1544|STANDARD_ERROR_OF_MEAN|13083.0|||TWO_SIDED||||||||Participants in the placebo group who successfully transitioned to oral feeding.|Analysis conducted using Generalized Linear Mixed Models with a logit link within SAS Proc GLIMMIX to model the binary outcome of transitioned to oral feeding (y/n) defined as at least 90 percent of calories consumed orally. Fixed effects (dummy variables) will be entered for each site as described by McNeish and Stapleton (2016) to account for the clustering of the participants within sites. This will result in essentially, a logistic regression model with appropriate standard errors.||||
71813156|NCT03815019|143128632|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED||||||||Pr(\>F) = 0.7846, Nested model using site as a predictor|||||
71813157|NCT03815019|143128633|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED||||||||Pr(\>F) = 0.7025, Nested model using site as a predictor|||||
71670669|NCT00813150|142858690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.645|TWO_SIDED|95.0|0.41|1.73|||Regression, Cox|||||1.73|0.41|0.645
71670670|NCT00813150|142858691|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
71670671|NCT03103087|142858706|SUPERIORITY||Treatment Difference|56.47|||<|0.0001|TWO_SIDED|95.0|46.45|66.49||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo.|||66.49|46.45|<0.0001
71813158|NCT03815019|143128634|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED||||||||Pr(\>F) = 0.6764, Nested model using site as a predictor|||||
71813159|NCT03815019|143128635|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7649, Nested model using site as a predictor|||||
71813160|NCT03815019|143128636|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||Pr(\>F) = 0.9487, Nested model using site as a predictor|||||
71813161|NCT03815019|143128637|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED||||||||Pr(\>F) = 0.7669, Nested model using site as a predictor|||||
71813162|NCT03815019|143128638|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED||||||||Pr(\>F) = 0.5883, Nested model using site as a predictor|||||
71813163|NCT03815019|143128639|SUPERIORITY||Mean Difference (Final Values)|0.52|||||TWO_SIDED||||||||Pr(\>F) = 0.4749, Nested model using site as a predictor|||||
71813164|NCT03815019|143128640|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED||||||||Pr(\>F) = 0.8781, Nested model using site as a predictor|||||
71813165|NCT03937219|143128648|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0131|TWO_SIDED|95.0|0.57|0.94|||Log Rank|||||0.94|0.57|0.0131
71813166|NCT00532155|143128650|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.8985|TWO_SIDED|95.0|0.868|1.174|||Stratified log-rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||1.174|0.868|0.8985
71813167|NCT00532155|143128651|SUPERIORITY_OR_OTHER_LEGACY||Stratified Hazard ratio|0.819||||0.0035|TWO_SIDED|95.0|0.716|0.937|||Stratified Log-Rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||0.937|0.716|0.0035
71813168|NCT02134925|143128661|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
71813169|NCT02134925|143128666|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71813170|NCT01091948|143128675|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Regression, Cox|Intubations accomplished with another device due to difficulty with assigned device and those took \>180 s were considered as failed intubations.||||||0.19
71813171|NCT01091948|143128676|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89||||0.58|TWO_SIDED|95.0|0.58|1.35|||ANCOVA||The mean intubation difficulty score was tested after logarithmic transformation, and then back transformed for the estimated treatment effect.|||1.35|0.58|0.58
71813172|NCT01091948|143128677|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.15|TWO_SIDED|95.0|0.95|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.95|0.15
71813173|NCT01091948|143128678|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.67||||0.57|TWO_SIDED|95.0|0.28|10.2|||Cochran-Mantel-Haenszel|||||10.2|0.28|0.57
71813174|NCT01091948|143128679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01||||0.79|TWO_SIDED|95.0|0.93|1.09|||Cochran-Mantel-Haenszel|||||1.09|0.93|0.79
71813175|NCT01091948|143128680|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.82|TWO_SIDED|95.0|0.45|2.76|||Regression, Logistic|proportional odds logistic regression model||||2.76|0.45|0.82
71896345|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|3.804||||0.01|TWO_SIDED|95.0|1.372|10.544||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||10.544|1.372|0.010
71787257|NCT03510884|143072626|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Odds Ratio (OR)|104.8|||=|0.0005|TWO_SIDED|97.5|5.2|2095.9||Threshold for significance at 0.025 level.|Regression, Logistic||Alirocumab Q4W versus Placebo Q4W: Combined estimate for odds ratio was obtained by combining the logarithm of odds ratio from logistic regression model analyses of the different imputed data sets, using Rubin's formulae.|Multiple imputation approach followed by logistic regression model. The logistic regression model stratified by randomization factors (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS included the fixed categorical effect of treatment group and the continuous fixed covariate of Baseline LDL-C value.||2095.9|5.2|=0.0005
71787258|NCT03510884|143072627|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-15.2|STANDARD_ERROR_OF_MEAN|6.7|=|0.0237|TWO_SIDED|97.5|-30.3|-0.1||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-0.1|-30.3|=0.0237
71787259|NCT03510884|143072627|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-24.9|STANDARD_ERROR_OF_MEAN|8.7|=|0.0043|TWO_SIDED|97.5|-44.4|-5.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||-5.4|-44.4|=0.0043
71787260|NCT03510884|143072628|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-5.6|STANDARD_ERROR_OF_MEAN|7.1|=|0.4288|TWO_SIDED|97.5|-21.7|10.4||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q2W versus Placebo Q2W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (previous participation \[yes or no\] to DFI14223 study, Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||10.4|-21.7|=0.4288
71787261|NCT03510884|143072628|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the considered dosing regimen).|Adjusted mean difference|-13.5|STANDARD_ERROR_OF_MEAN|8.6|=|0.1148|TWO_SIDED|97.5|-32.7|5.7||Threshold for significance at 0.025 level.|Robust regression model||Alirocumab Q4W versus Placebo Q4W|Multiple imputation approach followed by robust regression model. The robust regression model included the fixed categorical effect of treatment group and randomization strata (Baseline BW \[\<50 or \>=50 kg\]) as per IVRS and the continuous fixed covariate of Baseline lipoprotein (a) value.||5.7|-32.7|=0.1148
71787262|NCT00856284|143072658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.03|||||ONE_SIDED|98.75||0.059||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||0.059||
71787263|NCT00856284|143072658|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.003||||||||0.003||
71813176|NCT00462280|143128683|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
71813177|NCT00079001|143128728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.|Hazard Ratio (HR)|0.97||||0.385|TWO_SIDED|95.0|0.0|1.174||Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.|Log Rank||Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo|The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.||1.174|0|0.385
71813178|NCT00079001|143128729|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.29|TWO_SIDED|95.0|0.7|1.12|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.12|0.70|0.29
71670672|NCT03103087|142858707|SUPERIORITY||Treatment Difference|47.3|||<|0.0001|TWO_SIDED|95.0|38.04|56.56||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel|Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for the difference is based on the normal approximation.||||56.56|38.04|<0.0001
71670673|NCT03103087|142858708|SUPERIORITY||Treatment Difference|-69.2|STANDARD_ERROR_OF_MEAN|7.58|<|0.0001|TWO_SIDED|95.0|-84.1|-54.3||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. Assessed at a 2-sided α = 0.05 significance.|Mixed Models Analysis||Treatment difference was relugolix plus E2/NETA minus placebo.|||-54.3|-84.1|<0.0001
71670674|NCT03103087|142858709|SUPERIORITY||Treatment Difference|55.88|||<|0.0001|TWO_SIDED|95.0|37.25|74.52||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||74.52|37.25|<0.0001
71670675|NCT03103087|142858710|SUPERIORITY||Treatment Difference|29.99|||<|0.0001|TWO_SIDED|95.0|15.6|44.38||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||44.38|15.6|<0.0001
71670676|NCT03103087|142858711|SUPERIORITY||Treatment Difference|-10.0|STANDARD_ERROR_OF_MEAN|8.03|=|0.2153|TWO_SIDED|95.0|-25.8|5.8||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||5.8|-25.8|=0.2153
71670677|NCT03103087|142858712|SUPERIORITY||Treatment Difference|-12.2|STANDARD_ERROR_OF_MEAN|4.57|=|0.0078|TWO_SIDED|95.0|-21.3|-3.2||LS Means based on analysis of covariance model including treatment, randomization stratification factors, Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World), and Baseline values as covariate.|ANCOVA|||||-3.2|-21.3|=0.0078
71670678|NCT03103087|142858713|SUPERIORITY||Treatment Difference|-33.4|STANDARD_ERROR_OF_MEAN|3.98|<|0.0001|TWO_SIDED|95.0|-41.2|-25.5||Assessed at a 2-sided α = 0.05 significance level.|Mixed Models Analysis||Relugolix plus E2/NETA minus placebo. Treatment, visit, region, Baseline MBL and treatment by visit interaction as fixed effects.|||-25.5|-41.2|<0.0001
71670679|NCT03103087|142858716|OTHER||Risk Ratio (RR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.07|0.33|||Fisher Exact|||||0.33|0.07|<0.0001
71670680|NCT03103087|142858721|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
71670681|NCT03103087|142858722|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71670682|NCT03103087|142858723|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
71670683|NCT03103087|142858724|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||< 0.0001
71670684|NCT03103087|142858725|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||<0.0001
71670685|NCT03103087|142858726|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71670686|NCT03103087|142858727|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||<0.0001
71670687|NCT03103087|142858728|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
71670688|NCT03103087|142858729|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71670689|NCT03103087|142858730|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71670690|NCT03103087|142858731|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71670691|NCT03103087|142858732|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71670692|NCT03103087|142858733|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included.|Mixed Models Analysis|||||||<0.0001
71670693|NCT03103087|142858734|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71754397|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.488
71754398|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.226
71754399|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.710
71754400|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.133||95.0||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.133
71670694|NCT03103087|142858735|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71754401|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.257
71754402|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.412||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.412
71754403|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.030
71754404|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.024
71754405|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.250
71787264|NCT00856284|143072664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.13|||||ONE_SIDED|98.75||-0.006||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.||-0.006||
71787265|NCT00856284|143072664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||ONE_SIDED|98.75||0.035||||||||0.035||
71754406|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.489
71754407|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.682||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.682
71754408|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.953
71754409|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.803||95.0||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.803
71787266|NCT02560584|143072665|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for a single propor|||"The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.~Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients"||||<0.0001
71787267|NCT02560584|143072667|SUPERIORITY||||||<|0.0001|||||||Exact one-sided test for single proporti|||"The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).~Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients."||||<0.0001
71787268|NCT01391559|143072674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.17||95.0|||||t-test, 2 sided|||||||0.17
71787269|NCT00267046|143072675|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fine and Gray method.|||||||<0.001
71787270|NCT01077856|143072713|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.34|||||TWO_SIDED|95.0|0.89|2.0|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.00|0.89|
71787271|NCT01077856|143072713|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|1.59|||||TWO_SIDED|95.0|0.0|4.77|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||4.77|0.00|
71787272|NCT01077856|143072713|SUPERIORITY_OR_OTHER_LEGACY||Standardized Prevalence Ratio (SPR)|0.86|||||TWO_SIDED|95.0|0.0|2.02|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)|||2.02|0.00|
71787273|NCT03950167|143072718|OTHER||Mean Difference (Final Values)|0.85||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting CCK level difference: hyperemesis group-control group|||||0.05
71787274|NCT03950167|143072718|OTHER||Mean Difference (Net)|0.68||||0.05|TWO_SIDED||||||t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial CCK level difference: hyperemesis group-control group|Since this is the first study comparing both CCK levels and GB functions in patients diagnosed with hyperemesis gravidarum (HG) and healthy pregnant women, a power analysis was not feasible.||||0.05
71787275|NCT03950167|143072719|OTHER||Mean Difference (Final Values)|0.91||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB wall thickness: Hyperemesis group-control group|||||0.05
71787276|NCT03950167|143072719|OTHER||Mean Difference (Final Values)|0.23||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB wall thickness: hyperemesis group-control group|||||0.05
71787277|NCT03950167|143072720|OTHER||Mean Difference (Final Values)|0.41||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB volume: hyperemesis group-control group|||||0.05
71754410|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.694
71754411|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.835||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.835
71754412|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.435
71754413|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.379
71754414|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.247
71754415|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.784
71754416|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.696
71670695|NCT03103087|142858736|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71754417|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.725
71754418|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.899
71787278|NCT03950167|143072720|OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB volume: hyperemesis group-control group|||||0.05
71787279|NCT03950167|143072721|OTHER||Mean Difference (Final Values)|0.22||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Fasting GB ejection fraction: hyperemesis group-control group|||||0.05
71787280|NCT03950167|143072721|OTHER||Mean Difference (Final Values)|0.63||||0.05|TWO_SIDED|||||A p value of \<0.05 was accepted as significant in all statistical analyses.|t-test, 2 sided||p value demonstrated above is the calculated value. Postprandial GB ejection fraction: hyperemesis group-control group|||||0.05
71787281|NCT02533427|143072722|OTHER||% Geometric Least Square Mean(GLSM)Ratio|107.36|||||TWO_SIDED|90.0|103.19|111.69|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||111.69|103.19|
71787282|NCT02533427|143072723|OTHER||% GLSM Ratio|115.14|||||TWO_SIDED|90.0|106.49|124.5|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||124.50|106.49|
71754419|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.782||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.782
71754420|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.307||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.307
71754421|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.457
71754422|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.712
71754423|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.403||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.403
71754424|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.713
71754425|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.498
71754426|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.963
71891949|NCT00461175|143305498|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.61|||||TWO_SIDED|95.0|0.96|2.7|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, breastfeeding at time of insertion and parity status.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.70|0.96|
71787283|NCT02533427|143072724|OTHER||% GLSM Ratio|105.43|||||TWO_SIDED|90.0|96.95|114.66|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||114.66|96.95|
71787284|NCT02533427|143072725|OTHER||% GLSM Ratio|248.89|||||TWO_SIDED|90.0|33.11|1870.81|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||1870.81|33.11|
71787285|NCT02533427|143072726|OTHER||% GLSM Ratio|107.71|||||TWO_SIDED|90.0|97.78|118.65|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||118.65|97.78|
71670696|NCT03103087|142858738|SUPERIORITY||||||<|0.0001||||||LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.|Mixed Models Analysis|||||||<0.0001
71670697|NCT03103087|142858745|SUPERIORITY|||||||0.0004||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||0.0004
71670698|NCT02549859|142858772|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71670699|NCT02549859|142858773|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71670700|NCT02549859|142858774|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71670701|NCT02549859|142858775|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71787286|NCT02533427|143072727|OTHER||% GLSM Ratio|115.02|||||TWO_SIDED|90.0|108.12|122.37|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||122.37|108.12|
71787287|NCT02533427|143072728|OTHER||% GLSM Ratio|121.06|||||TWO_SIDED|90.0|106.1|138.12|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||138.12|106.10|
71787288|NCT02533427|143072729|OTHER||% GLSM Ratio|112.11|||||TWO_SIDED|90.0|87.19|144.14|||||Test/Reference: Norgestimate Part B/Part A|Norgestimate Part B/Part A||144.14|87.19|
71670702|NCT02549859|142858776|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71754427|NCT00385671|143011910|SUPERIORITY_OR_OTHER|||||||0.338||95.0||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).||||0.338
71787289|NCT02533427|143072730|OTHER||% GLSM Ratio|114.19|||||TWO_SIDED|90.0|107.4|121.39|||||Test/Reference: Norelgestromin Part B/Part A|Norelgestromin Part B/Part A||121.39|107.40|
71787290|NCT02533427|143072731|OTHER||% GLSM Ratio|121.62|||||TWO_SIDED|90.0|110.85|133.44|||||Test/Reference: Norgestrel Part B/Part A|Norgestrel Part B/Part A||133.44|110.85|
71787291|NCT02533427|143072732|OTHER||% GLSM Ratio|92.86|||||TWO_SIDED|90.0|82.55|104.45|||||Test/Reference: Ethinyl estradiol Part B/Part A|Ethinyl estradiol Part B/Part A||104.45|82.55|
71670703|NCT02549859|142858777|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71670704|NCT02549859|142858778|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71670705|NCT02549859|142858779|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71670706|NCT02549859|142858780|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71670707|NCT02549859|142858781|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71787292|NCT01442493|143072750|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
71787293|NCT01442493|143072751|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||0.06
71787294|NCT01442493|143072752|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71787295|NCT01442493|143072753|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71787296|NCT01442493|143072754|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
71787297|NCT01442493|143072755|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71787298|NCT01442493|143072756|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71813179|NCT00079001|143128730|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.22|TWO_SIDED|95.0|0.74|1.07|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group|||1.07|0.74|0.22
71813180|NCT02332590|143128731|SUPERIORITY||LS Mean Difference|-1.077|||<|0.0001|TWO_SIDED|95.0|-1.361|-0.793||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline DAS28-ESR score as a continuous covariate. Hierarchical testing procedure was used to control overall alpha error rate at 0.05 level and handle multiple endpoint analyses. Testing was then performed sequentially in order endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-0.793|-1.361|<0.0001
71813181|NCT02332590|143128732|SUPERIORITY||Odds Ratio (OR)|4.879|||<|0.0001|TWO_SIDED|95.0|2.536|9.389||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||9.389|2.536|<0.0001
71813182|NCT02332590|143128733|SUPERIORITY||Odds Ratio (OR)|1.976||||0.0017|TWO_SIDED|95.0|1.289|3.028||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||3.028|1.289|0.0017
71813183|NCT02332590|143128734|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0036|TWO_SIDED|95.0|1.3|4.02||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||4.020|1.300|0.0036
71813184|NCT02332590|143128735|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0074|TWO_SIDED|95.0|1.168|2.773||Threshold for significance 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.||2.773|1.168|0.0074
71813185|NCT02332590|143128736|SUPERIORITY||LS Mean Difference|-0.182||||0.0037|TWO_SIDED|95.0|-0.305|-0.059||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI score as a continuous covariate.||-0.059|-0.305|0.0037
71813186|NCT02332590|143128737|SUPERIORITY||LS Mean Difference|2.65||||0.0006|TWO_SIDED|95.0|1.147|4.153||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline SF-36 PCS score as a continuous covariate.||4.153|1.147|0.0006
71813187|NCT02332590|143128738|SUPERIORITY||LS Mean Difference|1.768||||0.0689|TWO_SIDED|95.0|-0.137|3.674||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline FACIT-F score as a continuous covariate.||3.674|-0.137|0.0689
71754428|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.645
71754429|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.248
71754430|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.||||0.470
71754431|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.914||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.914
71891950|NCT00461175|143305498|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.65|||||TWO_SIDED|95.0|0.99|2.78|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, time since last delivery, experience of the inserting health care provider.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.||2.78|0.99|
71754432|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.505
71670708|NCT02549859|142858782|SUPERIORITY||||||<|0.01|||||||Paired t-test, 2 sided|||||||<0.01
71813188|NCT00916032|143128784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.103||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.103
71813189|NCT00916032|143128785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||95.0|||||paired t-test done on the Log(AUC 0-48h)|||||||0.162
71891951|NCT00461175|143305499|SUPERIORITY_OR_OTHER||Pearl Index|0.06|||||TWO_SIDED|95.0|0.04|0.09||||||||0.09|0.04|
71891952|NCT00461175|143305499|SUPERIORITY_OR_OTHER||Pearl Index|0.52|||||TWO_SIDED|95.0|0.42|0.64||||||||0.64|0.42|
71891953|NCT00461175|143305499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||||TWO_SIDED|95.0|0.1|0.25|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, and parity.|||0.25|0.10|
71891954|NCT00327444|143305505|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|31.8|STANDARD_ERROR_OF_MEAN|10.59||0.0019|TWO_SIDED|95.0|10.56|53.05||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||53.05|10.56|0.0019
71891955|NCT00327444|143305506|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|375.5|STANDARD_ERROR_OF_MEAN|205.99||0.016|TWO_SIDED|95.0|-46.48|797.42||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference was estimated for aflibercept versus placebo (aflibercept-placebo).|||797.42|-46.48|0.0160
71891956|NCT00327444|143305507|SUPERIORITY_OR_OTHER||Least squares (LS) Mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.94||0.0035|TWO_SIDED|95.0|-4.33|-0.54||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=\<2 weeks versus \>2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).|||-0.54|-4.33|0.0035
71670709|NCT02549859|142858783|SUPERIORITY||||||<|0.001|||||||Paired t-test, 2 sided|||||||<0.001
71670710|NCT02549859|142858784|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71896346|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|2.555||||0.083|TWO_SIDED|95.0|0.886|7.369||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||7.369|0.886|0.083
71670711|NCT02549859|142858785|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71670712|NCT02549859|142858786|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71670713|NCT02549859|142858787|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71670714|NCT02549859|142858788|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71670715|NCT02549859|142858789|SUPERIORITY||||||<|0.05|||||||Paired t-test, 2 sided|||||||<0.05
71670716|NCT02549859|142858790|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71670717|NCT02549859|142858791|SUPERIORITY||||||>|0.05|||||||Paired t-test, 2 sided|||||||>0.05
71670718|NCT03664232|142858793|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09|=|0.284|TWO_SIDED|80.0|-0.17|0.07|||Mixed effects model for repeatedmeasures|||||0.07|-0.17|=0.284
71670719|NCT03664232|142858794|SUPERIORITY||Least-Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.1|=|0.29|TWO_SIDED|80.0|-0.18|0.07|||MMRM|||||0.07|-0.18|=0.290
71670720|NCT03664232|142858795|SUPERIORITY||Least-Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.1|=|0.231|TWO_SIDED|80.0|-0.21|0.06|||MMRM|||||0.06|-0.21|=0.231
71670721|NCT01062425|142858918|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||One-sided test with significance level of 0.15.|Z-test|||The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.||||0.005
71670722|NCT01062425|142858919|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.44|TWO_SIDED|95.0|0.6|1.24||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||1.24|0.6|0.44
71670723|NCT01062425|142858919|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.648|TWO_SIDED|95.0|0.62|1.34|||Regression, Cox||Placebo is reference level for the hazard ratio.|Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.||1.34|0.62|0.648
71670724|NCT01062425|142858920|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.03|TWO_SIDED|95.0|0.47|0.95||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.|||0.95|0.47|0.03
71670725|NCT01062425|142858920|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.036|TWO_SIDED|95.0|0.46|0.97|||Regression, Cox||Placebo is the reference arm.|Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.||0.97|0.46|0.036
71670726|NCT01062425|142858921|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Significance level 0.05, two-sided test.|Chi-squared|||||||0.02
71787299|NCT01830699|143072767|NON_INFERIORITY_OR_EQUIVALENCE|For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.|Mean Difference (Final Values)|-23.9||||0.004|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.004
71670727|NCT02342678|142858922|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||||2.2|-0.3|0.13
71670728|NCT02342678|142858923|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.18|TWO_SIDED|95.0|-0.2|1.1|||ANCOVA|||||1.1|-0.2|0.18
71787300|NCT01830699|143072768|NON_INFERIORITY_OR_EQUIVALENCE|See details above regarding effect size, power, etc.||||||0.044|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."||||0.044
71670729|NCT02342678|142858924|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||ANCOVA|||||1.3|-1.2|0.89
71670730|NCT02342678|142858925|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.13|TWO_SIDED|95.0|-0.3|2.0|||ANCOVA|||||2.0|-0.3|0.13
71670731|NCT02342678|142858926|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.73|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.73
71670732|NCT02342678|142858927|SUPERIORITY||Mean Difference (Final Values)|-19.3||||0.38|TWO_SIDED|95.0|-62.9|24.3|||ANCOVA|||||24.3|-62.9|0.38
71670733|NCT02342678|142858928|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.24|TWO_SIDED|95.0|-3.7|14.8|||ANCOVA|||||14.8|-3.7|0.24
71670734|NCT02342678|142858929|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|||||0.9|-0.4|0.46
71670735|NCT00460603|142858955|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.585||||0.9726|TWO_SIDED|95.0|0.332|1.031|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus \[vs.\] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.031|0.332|0.9726
71670736|NCT00460603|142858955|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.735||||0.8391|TWO_SIDED|95.0|0.399|1.352|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.352|0.399|0.8391
71670737|NCT00460603|142858955|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.797||||0.8192|TWO_SIDED|95.0|0.489|1.299|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.||1.299|0.489|0.8192
71670738|NCT00460603|142858987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.5699|TWO_SIDED|95.0|0.47|2.45|||Log Rank|||Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.45|0.47|0.5699
71670739|NCT00460603|142858987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.2167|TWO_SIDED|95.0|0.33|1.61|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.61|0.33|0.2167
71787301|NCT01111149|143072785|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Cotinine at Week 12||||>0.05
71670740|NCT00460603|142858987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.8746|TWO_SIDED|95.0|0.75|2.98|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.98|0.75|0.8746
71670741|NCT00460603|142858988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8884|TWO_SIDED|95.0|0.81|2.41|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.41|0.81|0.8884
71670742|NCT00460603|142858988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.6648|TWO_SIDED|95.0|0.66|1.89|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.89|0.66|0.6648
71670743|NCT00460603|142858988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.8065|TWO_SIDED|95.0|0.75|2.07|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.07|0.75|0.8065
71670744|NCT00460603|142858989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.155||||0.6904|TWO_SIDED|95.0|0.656|2.033|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.033|0.656|0.6904
71670745|NCT00460603|142858989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.203||||0.7364|TWO_SIDED|95.0|0.676|2.141|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||2.141|0.676|0.7364
71670746|NCT00460603|142858989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.941||||0.414|TWO_SIDED|95.0|0.535|1.653|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).||1.653|0.535|0.4140
71754433|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.||||0.570
71754434|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.430
71754435|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.090
71787302|NCT01111149|143072785|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Nicotine at Week 12||||>0.05
71787303|NCT01111149|143072785|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Cotinine at Week 12||||>0.05
71787304|NCT01111149|143072785|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Nicotine at Week 12||||>0.05
71787305|NCT01111149|143072786|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)||||>0.05
71787306|NCT01111149|143072786|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)||||>0.05
71787307|NCT01111149|143072786|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)||||>0.05
71787308|NCT01111149|143072786|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)||||>0.05
71787309|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Composite (Week 12)||||>0.05
71787310|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Global (Week 12)||||>0.05
71787311|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Affective Flattening (Week 12)||||>0.05
71787312|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Alogia (Week 12)||||>0.05
71787313|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Avolition (Week 12)||||>0.05
71787314|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Anhedonia (Week 12)||||>0.05
71787315|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Attention (Week 12)||||>0.05
71754436|NCT00385671|143011911|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.||||0.341
71754437|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.130
71754438|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.192||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.192
71754439|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.||||0.936
71754440|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.480
71670747|NCT00289848|142859004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_DEVIATION|1.08|<|0.001||95.0|-1.23|-0.83|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline A1C as a covariate||||-0.83|-1.23|<0.001
71670748|NCT00289848|142859005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0|STANDARD_DEVIATION|39.8|<|0.001||95.0|-38.4|-23.7|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline FPG as a covariate||||-23.7|-38.4|<0.001
71670749|NCT00289848|142859006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-56.6|STANDARD_DEVIATION|59.2|<|0.001||95.0|-68.8|-44.3|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline 2-hr PMG as a covariate||||-44.3|-68.8|<0.001
71670750|NCT00860795|142859007|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||.17
71754441|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.690
71754442|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.923||95.0||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.||||0.923
71754443|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.202||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.202
71787316|NCT01111149|143072787|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Inappropriate Affect at Week 12||||>0.05
71787317|NCT01111149|143072788|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT % Omissions (Week 12)||||>0.05
71787318|NCT01111149|143072788|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT% commissions (Week 12)||||>0.05
71787319|NCT01111149|143072788|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for perseveration % (week 12)||||>0.05
71787320|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Anxiety at week 12||||>0.05
71787321|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dizziness at week 12||||>0.05
71670751|NCT00860795|142859008|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|95.0|||||Regression, Linear|||||||.72
71670752|NCT00860795|142859009|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Regression, Linear|||||||.2
71670753|NCT00860795|142859011|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|95.0|||||Regression, Linear|||||||.51
71670754|NCT00860795|142859012|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Regression, Linear|||||||.43
71787322|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Mania at week 12||||>0.05
71787323|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for abnormal dreams at week 12||||>0.05
71787324|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Abdominal Pain at week 12||||>0.05
71754444|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.114
71754445|NCT00385671|143011912|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.||||0.954
71754446|NCT00385671|143011913|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.|Regression, Linear|||||||0.107
71754447|NCT00385671|143011914|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.968
71787325|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Headache at week 12||||>0.05
71787326|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Insomnia at week 12||||>0.05
71787327|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Nausea at week 12||||>0.05
71787328|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Psychosis at week 12||||>0.05
71787329|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dry Mouth at week 12||||>0.05
71787330|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Chest Pain at Week 12||||>0.05
71787331|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irregular Heart Beat at week 12||||>0.05
71787332|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Weakness/Fainting at week 12||||>0.05
71787333|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Diarrhea at week 12||||>0.05
71787334|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Vomiting at week 12||||>0.05
71787335|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Constipation at week 12||||>0.05
71787336|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Confusion at week 12||||>0.05
71787337|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irritability at week 12||||>0.05
71787338|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for drooling at week 12||||>0.05
71787339|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Cold Sweats at week 12||||>0.05
71787340|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Blurred Vision at week 12||||>0.05
71787341|NCT01111149|143072789|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Leg Pain/Cramps||||>0.05
71787342|NCT01111149|143072790|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for FTND (Week 12)||||>0.05
71787343|NCT01111149|143072790|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 24 Hour Total (Week 12)||||>0.05
71787344|NCT01111149|143072790|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 7 day total (Week 12)||||>0.05
71787345|NCT01111149|143072790|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS Resistance (Week 12)||||>0.05
71787346|NCT01111149|143072791|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis of Beck Depression Inventory (Week 12)||||>0.05
71787347|NCT01111149|143072792|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAS (Week 12)||||>0.05
71787348|NCT01111149|143072792|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS items 1-3 (week 12)||||>0.05
71787349|NCT01111149|143072792|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS item 4 (Week 12)||||>0.05
71787350|NCT01111149|143072793|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for systolic blood pressure (Week 12)||||>0.05
71787351|NCT01111149|143072793|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for diastolic blood pressure (Week 12)||||>0.05
71787352|NCT01111149|143072794|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Weight (Week 12)||||>0.05
71787353|NCT01111149|143072795|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)||||>0.05
71787354|NCT01111149|143072796|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)||||>0.05
71787355|NCT01111149|143072797|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Pulse (Week 12)||||>0.05
71787356|NCT01111149|143072798|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicidal Ideation (Week 12)||||>0.05
71787357|NCT01111149|143072798|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicide Attempts (Week 12)||||>0.05
71787358|NCT01111149|143072799|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Composite Score - Week 12||||>0.05
71754448|NCT00385671|143011914|SUPERIORITY_OR_OTHER|||||||0.492||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.492
71754449|NCT00385671|143011914|SUPERIORITY_OR_OTHER|||||||0.463||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.||||0.463
71787359|NCT01111149|143072799|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Global - Week 12||||>0.05
71787360|NCT01111149|143072799|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Hallucinations - Week 12||||>0.05
71787361|NCT01111149|143072799|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Delusions - Week 12||||>0.05
71787362|NCT01111149|143072799|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for SAPS Bizarre Behavior - Week 12||||>0.05
71787363|NCT01111149|143072799|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Thought Disorder - Week 12||||>0.05
71787364|NCT01111149|143072800|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Total - Week 12||||>0.05
71787365|NCT01111149|143072800|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Positive Subscale - Week 12||||>0.05
71787366|NCT01111149|143072800|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Negative Subscale - Week 12||||>0.05
71787367|NCT01111149|143072800|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Mania Subscale - Week 12||||>0.05
71787368|NCT01111149|143072800|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Disorientation Subscale - Week 12||||>0.05
71787369|NCT01111149|143072800|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Depression Subscale - Week 12||||>0.05
71787370|NCT01111149|143072801|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Hit Reaction Time - CPT (Week 12)||||>0.05
71787371|NCT01111149|143072802|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Variability of Standard Error - CPT (Week 12)||||>0.05
71787372|NCT01111149|143072803|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)||||>0.05
71787373|NCT01111149|143072804|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)||||>0.05
71787374|NCT01111149|143072805|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Total (Week 12)||||>0.05
71787375|NCT01111149|143072805|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for WISDM Cognition (Week 12)||||>0.05
71787376|NCT01111149|143072805|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Craving (Week 12)||||>0.05
71787377|NCT01111149|143072806|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Urge to Smoke (Week 12)||||>0.05
71787378|NCT01111149|143072806|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Strong Urge (Week 12)||||>0.05
71787379|NCT01111149|143072807|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Total (Week 12)||||>0.05
71787380|NCT01111149|143072807|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Severity Index (Week 12)||||>0.05
71787381|NCT01111149|143072807|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Statistical Analysis for AIMS Global Score (Week 12)||||>0.05
71787382|NCT00759954|143072808|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|97.19|||<|0.05||90.0|91.31|103.45|||ANOVA|||||103.45|91.31|<0.05
71787383|NCT00759954|143072810|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|95.82|||<|0.05||90.0|92.93|98.8|||ANOVA|Analysis of Variance for the log-transformed AUC. The 90% confidence interval for the ratio of AUC(Test)/AUC(Ref) is provided.||||98.80|92.93|< 0.05
71787384|NCT00759954|143072811|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p \< 0.05.|mean ratio|98.1|||<|0.05||90.0|94.2|102.1|||ANOVA|||||102.1|94.2|< 0.05
71787385|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.01||||90.0|-0.041|-0.007|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.041|
71787386|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.04|-0.003|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.003|-0.040|
71787387|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.038|0.001|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.001|-0.038|
71754450|NCT00385671|143011917|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.103
71754451|NCT00385671|143011917|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.167
71754452|NCT00385671|143011917|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.||||0.919
71754453|NCT00385671|143011920|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.008
71754454|NCT00385671|143011920|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.033
71754455|NCT00385671|143011920|SUPERIORITY_OR_OTHER|||||||0.688||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.||||0.688
71754456|NCT00385671|143011922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.365|TWO_SIDED|95.0|-0.33|0.9||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.90|-0.33|0.365
71754457|NCT00385671|143011922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.172|TWO_SIDED|95.0|-0.2|1.13||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||1.13|-0.20|0.172
71754458|NCT00385671|143011922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.594|TWO_SIDED|95.0|-0.49|0.85||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.||0.85|-0.49|0.594
71754459|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.622|TWO_SIDED|95.0|-0.48|0.8||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||0.80|-0.48|0.622
71754460|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49||||0.153|TWO_SIDED|95.0|-0.18|1.16||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.16|-0.18|0.153
71670755|NCT00860795|142859013|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||.61
71670756|NCT03871543|142859014|OTHER|Statistical Difference|Mean difference|0.159|STANDARD_ERROR_OF_MEAN|0.287|||ONE_SIDED|95.0|-0.402||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Upper Lid|||-0.402|
71670757|NCT03871543|142859014|OTHER|Statistical Difference|Mean Difference|0.236|STANDARD_ERROR_OF_MEAN|0.289|||ONE_SIDED|95.0|-0.328||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|Lower Lid|||-0.328|
71670758|NCT03871543|142859015|OTHER|Statistical difference|Mean Ratio|0.918|||||ONE_SIDED|95.0||1.227|||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean ratio was calculated as Symptomatic divided by Asymptomatic|||1.227||
71670759|NCT03871543|142859016|OTHER|Statistical difference|Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.019|||ONE_SIDED|95.0||0.022|||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic|||0.022||
71670760|NCT03871543|142859017|OTHER|Statistical difference|Mean Difference|1.185|STANDARD_ERROR_OF_MEAN|3.483|||ONE_SIDED|95.0|-4.613||||Mixed Models Analysis|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Symptomatic minus Asymptomatic||||-4.613|
71670761|NCT03871543|142859018|OTHER|Statistical difference|Mean Ratio|1.984|||||ONE_SIDED|95.0|1.198||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Upper Lid|||1.198|
71670762|NCT03871543|142859018|OTHER|Statistical Difference|Mean Ratio|1.8|||||ONE_SIDED|95.0|1.093||||Generalized Linear Mixed Model|The Kenward and Roger Method was used for the denominator degrees of freedom.|Mean Ratio was calculated as Symptomatic divided by Asymptomatic|Lower Lid|||1.093|
71670763|NCT03871543|142859019|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1416||||0.3446|TWO_SIDED|95.0|-0.4148|0.1551|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1551|-0.4148|0.3446
71670764|NCT03871543|142859020|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0887||||0.5556|TWO_SIDED|95.0|-0.207|0.3694|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3694|-0.2070|0.5556
71670765|NCT03871543|142859021|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2052||||0.1676|TWO_SIDED|95.0|-0.4676|0.0905|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0905|-0.4676|0.1676
71670766|NCT03871543|142859022|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0903||||0.5483|TWO_SIDED|95.0|-0.2054|0.3709|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3709|-0.2054|0.5483
71754461|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.344|TWO_SIDED|95.0|-0.35|1.0||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.00|-0.35|0.344
71787388|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.012||||90.0|-0.058|-0.019|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.058|
71787389|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.065|-0.02|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.065|
71787390|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.043|0.002|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.043|
71787391|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.066|-0.02|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.020|-0.066|
71670767|NCT03871543|142859023|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2679||||0.0719|TWO_SIDED|95.0|-0.5205|0.0278|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0278|-0.5205|0.0719
71670768|NCT03871543|142859024|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.3434||||0.019|TWO_SIDED|95.0|-0.5786|0.0554|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.0554|-0.5786|0.0190
71670769|NCT03871543|142859025|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.2975||||0.042|TWO_SIDED|95.0|-0.541|-0.0078|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||-0.0078|-0.5410|0.0420
71670770|NCT03871543|142859026|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.127||||0.3973|TWO_SIDED|95.0|-0.1696|0.4024|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.4024|-0.1696|0.3973
71670771|NCT03871543|142859027|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.021||||0.8894|TWO_SIDED|95.0|-0.3094|0.271|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.2710|-0.3094|0.8894
71670772|NCT03871543|142859028|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|0.0762||||0.6129|TWO_SIDED|95.0|-0.219|0.3585|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.3585|-0.2190|0.6129
71754462|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.058|TWO_SIDED|95.0|-0.02|1.45||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.45|-0.02|0.058
71754463|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.032|TWO_SIDED|95.0|0.07|1.59||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||1.59|0.07|0.032
71754464|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.762|TWO_SIDED|95.0|-0.66|0.9||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.||0.90|-0.66|0.762
71754465|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.029|TWO_SIDED|95.0|0.09|1.73||P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.73|0.09|0.029
71754466|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12||||0.01|TWO_SIDED|95.0|0.27|1.97||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.97|0.27|0.010
71754467|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.619|TWO_SIDED|95.0|-0.63|1.06||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.||1.06|-0.63|0.619
71754468|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.058|TWO_SIDED|95.0|-0.03|1.69||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||1.69|-0.03|0.058
71754469|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.001|TWO_SIDED|95.0|0.61|2.41||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.||2.41|0.61|0.001
71754470|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.142|TWO_SIDED|95.0|-0.23|1.58||P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.58|-0.23|0.142
71754471|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.065|TWO_SIDED|95.0|-0.05|1.76||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.76|-0.05|0.065
71813190|NCT03764072|143128802|SUPERIORITY|||||||0.2107||||||Dose response Model - Linear|Multiple Comparison Procedure-Modelling|||||||0.2107
71813191|NCT03764072|143128802|SUPERIORITY|||||||0.0766||||||Dose response Model - Emax|Multiple Comparison Procedure-Modelling|||||||0.0766
71891957|NCT00552110|143305512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||"Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.~Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points."||||0.002
71891958|NCT00552110|143305512|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.||||<0.001
71891959|NCT00552110|143305512|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.||||<0.001
71891960|NCT00552110|143305513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021||95.0||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.||||0.021
71891961|NCT00552110|143305513|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily||||<0.001
71891962|NCT00552110|143305513|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo||||<0.001
71891963|NCT02700451|143305514|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||Threshold for statistical significance was p = 0.05|Kruskal-Wallis|||The distribution of OME total in the first 72H is the same across these arms||||<0.001
71891964|NCT02700451|143305514|EQUIVALENCE|Two-sided 95% confidence interval|||||<|0.001||||||The thresholds for statistical significant was p = 0.05|Kruskal-Wallis|||The distribution of OME total to discharge is the same across these arms||||<0.001
71891965|NCT02700451|143305515|EQUIVALENCE|Two-sided||||||0.048|||||||Chi-squared|||Similar Distribution of opioid use between the 3 arms||||0.048
71891966|NCT02700451|143305516|EQUIVALENCE|Two-sided||||||0.595|||||||Chi-squared|||||||0.595
71670773|NCT03871543|142859029|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1402||||0.3493|TWO_SIDED|95.0|-0.4137|0.1565|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1565|-0.4137|0.3493
71670774|NCT03871543|142859030|OTHER|Statistical significance correlation: Statistically Significant correlations were concluded if the upper CL is below 0 or the lower CL is above 0|Correlation Coefficient|-0.1192||||0.427|TWO_SIDED|95.0|-0.3958|0.1772|||Pearson correlation|Pearson correlation statistics using Fisher's z transformation||||0.1772|-0.3958|0.4270
71670775|NCT02069015|142859038|SUPERIORITY||Mean Difference|0.05|||<|0.001|TWO_SIDED|95.0|-4.781|6.906|||paired t-test|||||6.906|-4.781|<0.001
71891967|NCT02700451|143305519|EQUIVALENCE|Two-sided 95% confidence interval||||||0.732|||||||Kruskal-Wallis|||The distribution of POD1 - Current pain level is the same across the 3 arms||||0.732
71891968|NCT02700451|143305519|EQUIVALENCE|Two-sided 95% confidence interval||||||0.896|||||||Kruskal-Wallis|||The distribution of POD1 - Best pain level is the same across the 3 arms||||0.896
71891969|NCT02700451|143305519|EQUIVALENCE|Two-sided 95% confidence interval||||||0.004|||||||Kruskal-Wallis|||The distribution of POD1 - Worst pain level is the same across the 3 arms||||0.004
71891970|NCT02700451|143305519|EQUIVALENCE|Two-sided 95% confidence interval||||||0.325|||||||Kruskal-Wallis|||The distribution of POD3 - Current pain level is the same across the 3 arms||||0.325
71670776|NCT01169064|142859044|SUPERIORITY_OR_OTHER|||||||0.365|||||||Chi-squared|||||||.365
71670777|NCT01169064|142859045|SUPERIORITY|||||||0.282|||||||Mixed Models Analysis|||||||.282
71891971|NCT02700451|143305519|EQUIVALENCE|Two-sided 95% confidence interval||||||0.283|||||||Kruskal-Wallis|||The distribution of POD3 - Best pain level is the same across the 3 arms||||0.283
71891972|NCT02700451|143305519|EQUIVALENCE|Two-sided 95% confidence interval||||||0.61|||||||Kruskal-Wallis|||The distribution of POD3 - Worst pain level is the same across the 3 arms||||0.610
71891973|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with General Activity is the same across the 3 arms||||0.016
71891974|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.294|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Mood is the same across the 3 arms||||0.294
71891975|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.016|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.016
71891976|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.082|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Normal work is the same across the 3 arms||||0.082
71891977|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.117|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Relation with other is the same across the 3 arms||||0.117
71813192|NCT03764072|143128802|SUPERIORITY|||||||0.0989||||||Dose response Model - Logistic|Multiple Comparison Procedure-Modelling|||||||0.0989
71813193|NCT03764072|143128802|SUPERIORITY|||||||0.0927||||||Dose-response Model - Sigmoid Emax|Multiple Comparison Procedure-Modelling|||||||0.0927
71813194|NCT03764072|143128804|SUPERIORITY|||||||0.3162|||||||Cochran-Mantel-Haenszel|||||||0.3162
71813195|NCT03764072|143128804|SUPERIORITY|||||||0.4613|||||||Cochran-Mantel-Haenszel|||||||0.4613
71813196|NCT03764072|143128804|SUPERIORITY|||||||0.4095|||||||Cochran-Mantel-Haenszel|||||||0.4095
71813197|NCT03764072|143128804|SUPERIORITY|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.1570
71813198|NCT03764072|143128804|SUPERIORITY|||||||0.9843|||||||Cochran-Mantel-Haenszel|||||||0.9843
71813199|NCT03764072|143128805|SUPERIORITY|||||||0.8714|||||||Cochran-Mantel-Haenszel|||||||0.8714
71787392|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.058|-0.009|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.009|-0.058|
71787393|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.039|0.009|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.009|-0.039|
71787394|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.027|0.017|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.017|-0.027|
71787395|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.037|0.012|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.012|-0.037|
71787396|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.014|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.014|-0.076|
71787397|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.076|-0.013|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.013|-0.076|
71787398|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.008|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.071|
71787399|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.074|-0.008|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.008|-0.074|
71891978|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.061|||||||Fisher Exact|||The distribution of POD1 - Pain has interfered with Sleep is the same across the 3 arms||||0.061
71891979|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.023|||||||Kruskal-Wallis|||The distribution of POD1 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.023
71787400|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.088|-0.025|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.025|-0.088|
71787401|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.019||||90.0|-0.071|-0.007|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.007|-0.071|
71787402|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.021||||90.0|-0.079|-0.01|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.079|
71787403|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.055|0.016|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.016|-0.055|
71787404|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.079|-0.004|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.079|
71787405|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.055|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.091|-0.019|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.019|-0.091|
71787406|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.081|-0.01|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.010|-0.081|
71787407|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.073|0.002|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.002|-0.073|
71813200|NCT03764072|143128805|SUPERIORITY|||||||0.5815|||||||Cochran-Mantel-Haenszel|||||||0.5815
71813201|NCT03764072|143128805|SUPERIORITY|||||||0.4308|||||||Cochran-Mantel-Haenszel|||||||0.4308
71813202|NCT03764072|143128805|SUPERIORITY|||||||0.4434|||||||Cochran-Mantel-Haenszel|||||||0.4434
71813203|NCT03764072|143128805|SUPERIORITY|||||||0.855|||||||Cochran-Mantel-Haenszel|||||||0.8550
71813204|NCT03764072|143128806|SUPERIORITY|||||||0.687|||||||Cochran-Mantel-Haenszel|||||||0.6870
71813205|NCT03764072|143128806|SUPERIORITY|||||||0.1515|||||||Cochran-Mantel-Haenszel|||||||0.1515
71813206|NCT03764072|143128806|SUPERIORITY|||||||0.603|||||||Cochran-Mantel-Haenszel|||||||0.6030
71813207|NCT03764072|143128806|SUPERIORITY|||||||0.1361|||||||Cochran-Mantel-Haenszel|||||||0.1361
71813208|NCT03764072|143128806|SUPERIORITY|||||||0.564|||||||Cochran-Mantel-Haenszel|||||||0.5640
71813209|NCT03764072|143128807|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.5405|TWO_SIDED|95.0|0.6|2.67|||Regression, Cox|||||2.67|0.60|0.5405
71787408|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.121|-0.038|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.038|-0.121|
71787409|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.038||||90.0|-0.124|0.003|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.003|-0.124|
71787410|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.02||||90.0|-0.098|-0.033|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.033|-0.098|
71787411|NCT00137046|143072812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.004|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.004|-0.085|
71787412|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.055||||90.0|-0.06|0.122|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.122|-0.060|
71787413|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.062||||90.0|0.033|0.239|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.239|0.033|
71787414|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.068||||90.0|0.0|0.224|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.000|
71787415|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.257|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.141|0.374|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.374|0.141|
71787416|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.071||||90.0|0.04|0.273|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.273|0.040|
71787417|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.072||||90.0|0.065|0.3|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.300|0.065|
71787418|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.078||||90.0|0.06|0.319|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.319|0.060|
71787419|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|STANDARD_ERROR_OF_MEAN|0.077||||90.0|0.19|0.443|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.443|0.190|
71787420|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.079||||90.0|-0.037|0.224|||ANCOVA|||Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.224|-0.037|
71787421|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.103|0.145|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.145|-0.103|
71845557|NCT00357994|143205612|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.07|STANDARD_ERROR_OF_MEAN|0.038||0.067|TWO_SIDED|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||0.146|-0.005|0.0670
71891980|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.681|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with General Activity is the same across the 3 arms||||0.681
71891981|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.405|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Mood is the same across the 3 arms||||0.405
71670778|NCT02857816|142859066|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.||||<0.0001
71670779|NCT02723344|142859070|OTHER|||||||0.056|||||||Wilcoxon-rank sum|||||||.056
71670780|NCT02723344|142859071|OTHER|||||||0.26||||||Wilcoxon Rank-Sum|Wilcoxon (Mann-Whitney)|||||||.26
71787422|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.082||||90.0|-0.023|0.248|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.248|-0.023|
71787423|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.273|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.126|0.419|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.419|0.126|
71787424|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|0.087||||90.0|0.219|0.507|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.507|0.219|
71891982|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.458|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Walking Ability is the same across the 3 arms||||0.458
71891983|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.482|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Normal work is the same across the 3 arms||||0.482
71670781|NCT02723344|142859073|OTHER|||||||0.64|||||||Wilcoxon Rank-Sum|||||||.64
71754472|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|0.75|2.65||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||2.65|0.75|<0.001
71754473|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.079|TWO_SIDED|95.0|-0.1|1.79||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.||1.79|-0.10|0.079
71754474|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.093|TWO_SIDED|95.0|-0.13|1.71||P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.71|-0.13|0.093
71754475|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56||||0.002|TWO_SIDED|95.0|0.59|2.53||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||2.53|0.59|0.002
71754476|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.119|TWO_SIDED|95.0|-0.2|1.74||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.||1.74|-0.20|0.119
71754477|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.036|TWO_SIDED|95.0|0.06|1.91||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.91|0.06|0.036
71754478|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.65|||<|0.001|TWO_SIDED|95.0|0.68|2.61||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.61|0.68|<0.001
71754479|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.178|TWO_SIDED|95.0|-0.3|1.63||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||1.63|-0.30|0.178
71787425|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.128|0.428|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.428|0.128|
71787426|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.091||||90.0|0.144|0.442|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.442|0.144|
71787427|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.094||||90.0|0.058|0.369|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.369|0.058|
71787428|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.086||||90.0|0.101|0.386|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.386|0.101|
71670782|NCT03473184|142859078|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||1|||||||ANOVA|||Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.||||1.0000
71670783|NCT03473184|142859078|OTHER|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||0.0008|||||||ANOVA|||Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.||||0.0008
71670784|NCT02964247|142859079|SUPERIORITY||Treatment difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.89|-0.48|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in HbA1c from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate.||-0.48|-0.89|<.001
71677191|NCT04143594|142873003|SUPERIORITY||Difference in percentage|-7.2||||0.3797|TWO_SIDED|95.0|-23.5|9.1||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.1|-23.5|0.3797
71754480|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81||||0.093|TWO_SIDED|95.0|-0.14|1.75||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.||1.75|-0.14|0.093
71754481|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.003|TWO_SIDED|95.0|0.53|2.51||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.||2.51|0.53|0.003
71787429|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.09||||90.0|0.079|0.376|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.376|0.079|
71787430|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.089||||90.0|0.079|0.372|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.372|0.079|
71787431|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.095||||90.0|0.055|0.368|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.368|0.055|
71787432|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.092||||90.0|0.18|0.483|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.483|0.180|
71787433|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462|STANDARD_ERROR_OF_MEAN|0.097||||90.0|0.302|0.622|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.622|0.302|
71787434|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.115||||90.0|0.221|0.6|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.600|0.221|
71787435|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|STANDARD_ERROR_OF_MEAN|0.161||||90.0|0.183|0.718|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.718|0.183|
71787436|NCT00137046|143072814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.174|0.237|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.||0.237|-0.174|
71787437|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|STANDARD_ERROR_OF_MEAN|6.33||||90.0|-25.24|-4.39|||ANCOVA|||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.39|-25.24|
71787438|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.83|STANDARD_ERROR_OF_MEAN|6.27||||90.0|-35.16|-14.51|||ANCOVA|||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.51|-35.16|
71787439|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|STANDARD_ERROR_OF_MEAN|6.92||||90.0|-37.56|-14.75|||ANCOVA|||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.75|-37.56|
71787440|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.46|STANDARD_ERROR_OF_MEAN|6.74||||90.0|-30.56|-8.36|||ANCOVA|||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-8.36|-30.56|
71670785|NCT02964247|142859079|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.74|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.94|-0.53|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand.The change in HbA1c from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate, all nested within visit.||-0.53|-0.94|<.001
71670786|NCT02964247|142859080|SUPERIORITY||Treatment difference|-0.82|STANDARD_ERROR_OF_MEAN|0.46||0.077|TWO_SIDED|95.0|-1.73|0.09|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in body weight from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate.||0.09|-1.73|0.077
71670787|NCT02964247|142859080|SUPERIORITY|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.062|TWO_SIDED|95.0|-1.77|0.04|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand. The change in body weight from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate, all nested within visit.||0.04|-1.77|0.062
71754482|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.157|TWO_SIDED|95.0|-0.28|1.71||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.||1.71|-0.28|0.157
71754483|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.063|TWO_SIDED|95.0|-0.05|1.82||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.82|-0.05|0.063
71670788|NCT01709500|142859105|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|95.0|-58.1|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the placebo group using an appropriate contrast statement.||-44.8|-58.1|<0.0001
71754484|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.7|2.66||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||2.66|0.70|<0.001
71754485|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.114|TWO_SIDED|95.0|-0.19|1.77||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.||1.77|-0.19|0.114
71787441|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.97|STANDARD_ERROR_OF_MEAN|6.65||||90.0|-50.93|-29.0|||ANCOVA|||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-29.00|-50.93|
71787442|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|STANDARD_ERROR_OF_MEAN|7.02||||90.0|-27.65|-4.51|||ANCOVA|||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.51|-27.65|
71787443|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|6.76||||90.0|-24.69|-2.39|||ANCOVA|||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-2.39|-24.69|
71787444|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.86|STANDARD_ERROR_OF_MEAN|7.29||||90.0|-30.88|-6.84|||ANCOVA|||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-6.84|-30.88|
71787445|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|8.12||||90.0|-9.83|16.96|||ANCOVA|||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||16.96|-9.83|
71787446|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|8.2||||90.0|-31.32|-4.27|||ANCOVA|||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-4.27|-31.32|
71787447|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|STANDARD_ERROR_OF_MEAN|7.72||||90.0|-33.44|-7.99|||ANCOVA|||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-7.99|-33.44|
71754486|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.295|TWO_SIDED|95.0|-0.44|1.46||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.46|-0.44|0.295
71754487|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.005|TWO_SIDED|95.0|0.45|2.44||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||2.44|0.45|0.005
71754488|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.066|TWO_SIDED|95.0|-0.06|1.94||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.||1.94|-0.06|0.066
71754489|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.208|TWO_SIDED|95.0|-0.35|1.58||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.58|-0.35|0.208
71754490|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.49|2.51||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||2.51|0.49|0.004
71754491|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.086|TWO_SIDED|95.0|-0.13|1.89||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.||1.89|-0.13|0.086
71754492|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.328|TWO_SIDED|95.0|-0.49|1.45||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.45|-0.49|0.328
71787448|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|7.8||||90.0|-11.06|14.66|||ANCOVA|||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||14.66|-11.06|
71787449|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.72|STANDARD_ERROR_OF_MEAN|9.02||||90.0|-23.61|6.17|||ANCOVA|||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||6.17|-23.61|
71787450|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.34|STANDARD_ERROR_OF_MEAN|7.84||||90.0|-29.28|-3.4|||ANCOVA|||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-3.40|-29.28|
71787451|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.99|STANDARD_ERROR_OF_MEAN|8.25||||90.0|-26.6|0.63|||ANCOVA|||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||0.63|-26.60|
71787452|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.22|STANDARD_ERROR_OF_MEAN|8.58||||90.0|-24.39|3.94|||ANCOVA|||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.94|-24.39|
71787453|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.64|STANDARD_ERROR_OF_MEAN|8.82||||90.0|-43.19|-14.09|||ANCOVA|||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||-14.09|-43.19|
71787454|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.99|STANDARD_ERROR_OF_MEAN|8.91||||90.0|-23.69|5.71|||ANCOVA|||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.71|-23.69|
71787455|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|STANDARD_ERROR_OF_MEAN|8.8||||90.0|-24.04|5.0|||ANCOVA|||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||5.00|-24.04|
71670789|NCT01709500|142859106|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.2|||<|0.0001|TWO_SIDED|95.0|-58.7|-45.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.||-45.6|-58.7|<0.0001
71891984|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.544|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Relation with other is the same across the 3 arms||||0.544
71891985|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.202|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Sleep is the same across the 3 arms||||0.202
71670790|NCT01709500|142859107|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.7|-42.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.2|-54.7|<0.0001
71670791|NCT01709500|142859108|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-55.0|-42.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-42.5|-55|<0.0001
71754493|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.005|TWO_SIDED|95.0|0.44|2.47||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||2.47|0.44|0.005
71754494|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98||||0.059|TWO_SIDED|95.0|-0.04|1.99||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.||1.99|-0.04|0.059
71754495|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.117|TWO_SIDED|95.0|-0.09|0.79||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.79|-0.09|0.117
71754496|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.412|TWO_SIDED|95.0|-0.25|0.62||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.62|-0.25|0.412
71754497|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.445|TWO_SIDED|95.0|-0.6|0.26||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.||0.26|-0.60|0.445
71787456|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|8.67||||90.0|-24.71|3.92|||ANCOVA|||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||3.92|-24.71|
71787457|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.17|STANDARD_ERROR_OF_MEAN|9.24||||90.0|-21.42|9.09|||ANCOVA|||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||9.09|-21.42|
71670792|NCT01709500|142859109|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.3|||<|0.0001|TWO_SIDED|95.0|-44.1|-34.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-34.5|-44.1|<0.0001
71670793|NCT01709500|142859110|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.8|||<|0.0001|TWO_SIDED|95.0|-44.5|-35.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-35.1|-44.5|<0.0001
71787458|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|9.44||||90.0|-20.98|10.21|||ANCOVA|||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||10.21|-20.98|
71787459|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.58|STANDARD_ERROR_OF_MEAN|13.77||||90.0|-38.43|7.26|||ANCOVA|||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||7.26|-38.43|
71891986|NCT02700451|143305520|EQUIVALENCE|Two-sided 95% confidence interval||||||0.58|||||||Kruskal-Wallis|||The distribution of POD3 - Pain has interfered with Enjoyment of life is the same across the 3 arms||||0.580
71891987|NCT02700451|143305522|EQUIVALENCE|Two-sided 95% confidence interval||||||0.928|||||||Kruskal-Wallis|||The distribution of Total Drain output at 24H is the same across the 3 arms||||0.928
71837147|NCT03683719|143180906|SUPERIORITY||Mean Difference (Net)|-13.41|||<|0.01|TWO_SIDED|95.0|-22.82|-4.01||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-4.01|-22.82|<0.01
71837148|NCT03683719|143180906|SUPERIORITY||Mean Difference (Net)|-9.53|||<|0.05|TWO_SIDED|95.0|-19.04|-0.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-0.02|-19.04|<0.05
71837149|NCT03683719|143180906|SUPERIORITY||Mean Difference (Net)|-20.29|||<|0.0001|TWO_SIDED|95.0|-29.56|-11.02||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-11.02|-29.56|<0.0001
71891988|NCT02700451|143305522|EQUIVALENCE|Two-sided 95% confidence interval||||||0.906|||||||Kruskal-Wallis|||The distribution of Total Drain output at 48H is the same across the 3 arms||||0.906
71891989|NCT02700451|143305522|EQUIVALENCE|Two-sided 95% confidence interval||||||0.926|||||||Kruskal-Wallis|||The distribution of Total Drain output at 72H is the same across the 3 arms||||0.926
71891990|NCT02700451|143305522|EQUIVALENCE|Two-sided 95% confidence interval||||||0.934|||||||Kruskal-Wallis|||The distribution of Total Drain output at Discharge is the same across the 3 arms||||0.934
71891991|NCT02700451|143305523|EQUIVALENCE|Two-sided||||||0.078|||||||Chi-squared|||Proportion of patient receiving at least 1 transfusion is the same across the 3 arms||||0.078
71891992|NCT02700451|143305524|EQUIVALENCE|Two-sided 95% confidence interval||||||792|||||||Chi-squared|||||||0792
71891993|NCT02700451|143305525|EQUIVALENCE|Two-sided 95% confidence interval||||||0.034|||||||Kruskal-Wallis|||The distribution of Length of stay in day is the same across these arms||||0.034
71891994|NCT02700451|143305525|EQUIVALENCE|Two-sided 95% confidence interval||||||0.03|||||||Kruskal-Wallis|||The distribution of Length of stay in hour is the same across these arms||||0.030
71891995|NCT02700451|143305526|EQUIVALENCE|Two-sided 95% confidence interval||||||0.974|||||||ANOVA|||Comparison of the PCS score between the 3 arms||||0.974
71891996|NCT02700451|143305526|EQUIVALENCE|Two-sided 95% confidence interval||||||0.444|||||||ANOVA|||Comparison of the MCS between the 3 ams||||0.444
71891997|NCT02700451|143305527|EQUIVALENCE|Two-sided 95% confidence interval||||||0.215|||||||ANOVA|||||||0.215
71891998|NCT02700451|143305528|EQUIVALENCE|Two-sided 95% confidence interval||||||0.044|||||||ANOVA|||Comparison PCS score between the 3 arms||||0.044
71891999|NCT02700451|143305528|EQUIVALENCE|Two-sided 95% confidence interval||||||0.767|||||||ANOVA|||Comparison MCS score between the 3 arms||||0.767
71892000|NCT02700451|143305529|EQUIVALENCE|Two-sided 95% confidence interval||||||0.191|||||||ANOVA|||||||0.191
71892001|NCT04373460|143305539|SUPERIORITY||Risk Difference (RD)|3.4||||0.005|TWO_SIDED|95.0|1.0|5.8|||Fisher Exact|||||5.8|1.0|0.005
71892002|NCT04373460|143305540|SUPERIORITY||Risk Difference (RD)|-0.05||||0.16|TWO_SIDED|95.0|-0.11|0.02|||Rate per person-years|||||0.02|-0.11|0.16
71892003|NCT04373460|143305541|SUPERIORITY||Incidence rate difference|0.18||||0.02|TWO_SIDED|95.0|0.03|0.32|||Rate per person-years|||||0.32|0.03|0.02
71892004|NCT04373460|143305542|SUPERIORITY||Risk Difference (RD)|0.01||||0.32|TWO_SIDED|95.0|-0.01|0.02|||Rate per person-years|||||0.02|-0.01|0.32
71892005|NCT04373460|143305547|SUPERIORITY|||||||0.65|||||||Fisher Exact|||||||0.65
71670794|NCT01709500|142859111|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.7|||<|0.0001|TWO_SIDED|95.0|-51.8|-39.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-39.7|-51.8|<0.0001
71892006|NCT04373460|143305551|SUPERIORITY||Risk Ratio (RR)|0.525|||||TWO_SIDED|95.0|0.192|1.425||||||||1.425|0.192|
71892007|NCT02115308|143305597|SUPERIORITY|||||||0.001|||||||paired, t-test|non-adjusted||REST-TO-REGADENOSON STRESS||||0.001
71892008|NCT02115308|143305597|SUPERIORITY|||||||0.017||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.017
71892009|NCT02115308|143305597|SUPERIORITY|||||||0.495||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS||||0.495
71892010|NCT02115308|143305597|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|non-adjusted||REST||||0.365
71892011|NCT02115308|143305597|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|non adjusted||REST||||0.602
71892012|NCT02115308|143305597|SUPERIORITY|||||||0.915|||||||t-test, 2 sided|non adjusted||REST||||0.915
71892013|NCT02115308|143305597|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.033
71892014|NCT02115308|143305597|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
71892015|NCT02115308|143305597|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.087
71892016|NCT02115308|143305597|SUPERIORITY|||||||0.399|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS CHANGE||||0.399
71892017|NCT02115308|143305597|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.030
71892018|NCT02115308|143305597|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change||||0.048
71892019|NCT02115308|143305598|SUPERIORITY|||||||0.011||||||Non-adjusted.|paired, t-test|||Rest VS Regadenoson Stress||||0.011
71892020|NCT02115308|143305598|SUPERIORITY|||||||0.003||||||non-adjusted|paired t-test|||Rest VS Regadenoson Stress||||0.003
71892021|NCT02115308|143305598|SUPERIORITY|non-adjusted||||||0.39|||||||paired, t-test|||Rest VS Regadenoson Stress||||0.390
71892022|NCT02115308|143305598|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
71892023|NCT02115308|143305598|SUPERIORITY|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST||||<0.000
71892024|NCT02115308|143305598|SUPERIORITY|non-adjusted||||||0.022|||||||t-test, 2 sided|||REST||||0.022
71892025|NCT02115308|143305598|SUPERIORITY|||||||0.001||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.001
71787460|NCT00137046|143072817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84|STANDARD_ERROR_OF_MEAN|11.27||||90.0|-15.79|21.46|||ANCOVA|||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.||21.46|-15.79|
71787461|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.523|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.846|-0.199|||ANCOVA|||Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.199|-0.846|
71787462|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.113|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-1.541|-0.685|||ANCOVA|||Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.685|-1.541|
71787463|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.359|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.836|-0.882|||ANCOVA|||Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.882|-1.836|
71787464|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.184|STANDARD_ERROR_OF_MEAN|0.314||||90.0|-1.702|-0.666|||ANCOVA|||Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.666|-1.702|
71787465|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.426|STANDARD_ERROR_OF_MEAN|0.338||||90.0|-1.984|-0.869|||ANCOVA|||Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.869|-1.984|
71787466|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.717|STANDARD_ERROR_OF_MEAN|0.384||||90.0|-2.35|-1.084|||ANCOVA|||Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.084|-2.350|
71787467|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.273|STANDARD_ERROR_OF_MEAN|0.411||||90.0|-1.95|-0.596|||ANCOVA|||Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.596|-1.950|
71787468|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.069|STANDARD_ERROR_OF_MEAN|0.439||||90.0|-1.792|-0.346|||ANCOVA|||Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.346|-1.792|
71787469|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.785|STANDARD_ERROR_OF_MEAN|0.418||||90.0|-1.475|-0.096|||ANCOVA|||Follow-up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.096|-1.475|
71787470|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|0.406||||90.0|-1.114|0.224|||ANCOVA|||Follow-up Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.224|-1.114|
71787471|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-1.133|1.025|||ANCOVA|||Extension Month 1; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||1.025|-1.133|
71787472|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.438|-0.235|||ANCOVA|||Extension Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.235|-2.438|
71787473|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.462|STANDARD_ERROR_OF_MEAN|0.542||||90.0|-2.356|-0.568|||ANCOVA|||Extension Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.568|-2.356|
71787474|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.385|STANDARD_ERROR_OF_MEAN|0.564||||90.0|-2.316|-0.454|||ANCOVA|||Extension Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.454|-2.316|
71787475|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.955|STANDARD_ERROR_OF_MEAN|0.559||||90.0|-1.877|-0.034|||ANCOVA|||Extension Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.034|-1.877|
71787476|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.588||||90.0|-1.97|-0.03|||ANCOVA|||Extension Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.030|-1.970|
71813210|NCT03764072|143128807|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9011|TWO_SIDED|95.0|0.49|2.27|||Regression, Cox|||||2.27|0.49|0.9011
71892026|NCT02115308|143305598|SUPERIORITY||||||<|0||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||<0.000
71892027|NCT02115308|143305598|SUPERIORITY|||||||0.006||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS||||0.006
71892028|NCT02115308|143305598|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||<0.000
71892029|NCT02115308|143305598|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Changes||||0.058
71892030|NCT02115308|143305598|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change||||0.310
71892031|NCT02115308|143305599|SUPERIORITY|||||||0.001|||||||paired, t-test|non adjusted||REST vs STRESS||||0.001
71892032|NCT02115308|143305599|SUPERIORITY|||||||0.002|||||||paired, t-test|non adjusted||REST vs STRESS||||0.002
71892033|NCT02115308|143305599|SUPERIORITY|||||||0.721|||||||paired, t-test|non adjusted||REST vs STRESS||||0.721
71670795|NCT01709500|142859112|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.3|-40.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-40.4|-52.3|<0.0001
71754498|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.025|TWO_SIDED|95.0|0.07|1.09||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||1.09|0.07|0.025
71837150|NCT03683719|143180906|SUPERIORITY||Mean Difference (Net)|-15.59|||<|0.01|TWO_SIDED|95.0|-24.82|-6.36||The statistical test was not controlled for multiplicity. Data at visits following premature discont. of IMP or initiation of rescue med. before Week 16 were considered missing and imputed with MMRM predicted values (as were any other missing data).|Mixed Models Analysis|||"Least Square (LS) Means were calculated using a mixed model for repeated measurements on the post-baseline responses up to Week 16 with an unstructured covariance matrix, Kenward-Roger approximation to estimate denominator degrees of freedom, and the mean modelled as follows:~Change from baseline in HECSI~= treatment × visit + baseline HECSI × visit + region + baseline IGA-CHE.~The primary comparison between each active delgocitinib dose and vehicle was at Week 16."||-6.36|-24.82|<0.01
71670796|NCT01709500|142859113|SUPERIORITY_OR_OTHER||LS Mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-37.4|-28.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-28.1|-37.4|<0.0001
71754499|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.257|TWO_SIDED|95.0|-0.21|0.79||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.79|-0.21|0.257
71754500|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.257|TWO_SIDED|95.0|-0.79|0.21||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.||0.21|-0.79|0.257
71754501|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.04||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||1.04|-0.05|0.075
71754502|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.634|TWO_SIDED|95.0|-0.42|0.68||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.68|-0.42|0.634
71754503|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.193|TWO_SIDED|95.0|-0.91|0.19||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.||0.19|-0.91|0.193
71754504|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.688|TWO_SIDED|95.0|-0.46|0.7||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.70|-0.46|0.688
71754505|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.944|TWO_SIDED|95.0|-0.6|0.56||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.56|-0.60|0.944
71892034|NCT02115308|143305599|SUPERIORITY|||||||0.797|||||||t-test, 2 sided|non adjusted||REST||||0.797
71892035|NCT02115308|143305599|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|non adjusted||REST||||0.474
71892036|NCT02115308|143305599|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|non adjusted||||||0.537
71892037|NCT02115308|143305599|SUPERIORITY|||||||0.717|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.717
71670797|NCT01709500|142859114|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-39.2|-29.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-29.8|-39.2|<0.0001
71670798|NCT01709500|142859115|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.0|||<|0.0001|TWO_SIDED|95.0|-47.8|-36.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-36.2|-47.8|<0.0001
71754506|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.64|TWO_SIDED|95.0|-0.73|0.45||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.||0.45|-0.73|0.640
71754507|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.439|TWO_SIDED|95.0|-0.37|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.37|0.439
71754508|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.461|TWO_SIDED|95.0|-0.38|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.84|-0.38|0.461
71787477|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.655||||90.0|-2.041|0.121|||ANCOVA|||Extension Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||0.121|-2.041|
71787478|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.667|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-2.77|-0.565|||ANCOVA|||Extension Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.565|-2.770|
71787479|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.872|STANDARD_ERROR_OF_MEAN|0.692||||90.0|-3.013|-0.73|||ANCOVA|||Extension Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.730|-3.013|
71787480|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.887|STANDARD_ERROR_OF_MEAN|0.725||||90.0|-3.084|-0.69|||ANCOVA|||Extension Month 27; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.690|-3.084|
71787481|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.794|STANDARD_ERROR_OF_MEAN|0.891||||90.0|-4.264|-1.324|||ANCOVA|||Extension Month 30; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.324|-4.264|
71787482|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.287|STANDARD_ERROR_OF_MEAN|1.091||||90.0|-5.088|-1.485|||ANCOVA|||Extension Month 33; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-1.485|-5.088|
71892038|NCT02115308|143305599|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.041
71892039|NCT02115308|143305599|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.050
71754509|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.976|TWO_SIDED|95.0|-0.62|0.6||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.||0.60|-0.62|0.976
71787483|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.486|STANDARD_ERROR_OF_MEAN|0.857||||90.0|-2.901|-0.071|||ANCOVA|||Extension Month 36; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.071|-2.901|
71787484|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.131|STANDARD_ERROR_OF_MEAN|1.356||||90.0|-5.382|-0.88|||ANCOVA|||Extension Month 39; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.880|-5.382|
71787485|NCT00137046|143072818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.487|STANDARD_ERROR_OF_MEAN|0.866||||90.0|-2.918|-0.055|||ANCOVA|||Extension Follow Up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.||-0.055|-2.918|
71787486|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.144||||90.0|-0.981|-0.506|||ANCOVA|||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.506|-0.981|
71813211|NCT03764072|143128807|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9127|TWO_SIDED|95.0|0.48|2.26|||Regression, Cox|||||2.26|0.48|0.9127
71892040|NCT02115308|143305599|SUPERIORITY|||||||0.908||||||non adjusted|t-test, 2 sided|||REST-to-STRESS Change||||0.908
71892041|NCT02115308|143305599|SUPERIORITY|||||||0.233|||||||t-test, 2 sided|non adjusted||||||0.233
71892042|NCT02115308|143305599|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.187
71670799|NCT01709500|142859116|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.9|||<|0.0001|TWO_SIDED|95.0|-34.5|-25.4|||Mixed Models Analysis|Threshold for significance ≤ 0.05.||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-25.4|-34.5|<0.0001
71670800|NCT01709500|142859117|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.8|||<|0.0001|TWO_SIDED|95.0|-66.8|-50.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||-50.8|-66.8|<0.0001
71787487|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.797|STANDARD_ERROR_OF_MEAN|0.167||||90.0|-1.073|-0.522|||ANCOVA|||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.522|-1.073|
71787488|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|STANDARD_ERROR_OF_MEAN|0.171||||90.0|-0.949|-0.384|||ANCOVA|||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.384|-0.949|
71670801|NCT01709500|142859118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|52.2|||<|0.0001|TWO_SIDED|95.0|20.9|130.0||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||130|20.9|<0.0001
71670802|NCT01709500|142859119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.3|||<|0.0001|TWO_SIDED|95.0|21.4|132.6||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||132.6|21.4|<0.0001
71787489|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.181||||90.0|-1.123|-0.528|||ANCOVA|||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.528|-1.123|
71787490|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.19||||90.0|-0.923|-0.296|||ANCOVA|||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.296|-0.923|
71892043|NCT02115308|143305601|SUPERIORITY|||||||0.008|||||||paired, t-test|non adjusted||REST vs STRESS||||0.008
71892044|NCT02115308|143305601|SUPERIORITY|||||||0.006|||||||paired, t-test|non adjusted||REST vs STRESS||||0.006
71892045|NCT02115308|143305601|SUPERIORITY|||||||0.428|||||||paired, t-test|non adjusted||REST vs STRESS||||0.428
71892046|NCT02115308|143305601|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
71892047|NCT02115308|143305601|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST||||<0.000
71892048|NCT02115308|143305601|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|non adjusted||REST||||0.006
71892049|NCT02115308|143305601|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.002
71670803|NCT01709500|142859120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|239.7|||<|0.0001|TWO_SIDED|95.0|31.6|1820.3||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1820.3|31.6|<0.0001
71787491|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.577|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.91|-0.245|||ANCOVA|||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.245|-0.910|
71787492|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-0.962|-0.263|||ANCOVA|||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.263|-0.962|
71787493|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.736|-0.034|||ANCOVA|||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.034|-0.736|
71813212|NCT03764072|143128807|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5619|TWO_SIDED|95.0|0.6|2.56|||Regression, Cox|||||2.56|0.60|0.5619
71892050|NCT02115308|143305601|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||<0.000
71892051|NCT02115308|143305601|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS||||0.004
71813213|NCT03764072|143128807|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.709|TWO_SIDED|95.0|0.5|2.79|||Regression, Cox|||||2.79|0.50|0.7090
71813214|NCT03764072|143128808|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.5141|TWO_SIDED|95.0|0.61|2.72|||Regression, Cox|||||2.72|0.61|0.5141
71813215|NCT03764072|143128808|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9614|TWO_SIDED|95.0|0.45|2.12|||Regression, Cox|||||2.12|0.45|0.9614
71813216|NCT03764072|143128808|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9756|TWO_SIDED|95.0|0.46|2.14|||Regression, Cox|||||2.14|0.46|0.9756
71813217|NCT03764072|143128808|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.5582|TWO_SIDED|95.0|0.6|2.57|||Regression, Cox|||||2.57|0.60|0.5582
71813218|NCT03764072|143128808|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7543|TWO_SIDED|95.0|0.49|2.71|||Regression, Cox|||||2.71|0.49|0.7543
71813219|NCT00558064|143128832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|0.57|<|0.0001|TWO_SIDED|95.0|3.98|6.23|||Mixed Models Analysis||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus amlodipine 5 mg monotherapy|||6.23|3.98|<0.0001
71813220|NCT03152084|143128844|OTHER|Within-group change|Least square mean|-5.21||||0.4462|TWO_SIDED|95.0|-19.542|9.12||Start of treatment vs baseline|Mixed Models Analysis|||||9.120|-19.542|0.4462
71813221|NCT03152084|143128845|OTHER|Within-group change|Least square mean|3.69||||0.7842|TWO_SIDED|95.0|-24.817|32.195||End of treatment vs baseline|Mixed Models Analysis|||||32.195|-24.817|0.7842
71813222|NCT03152084|143128845|OTHER|Within-group change|Least square mean|-16.72||||0.0581|TWO_SIDED|95.0|-34.109|0.664||Follow-up vs End of treatment|Regression, Linear|||||0.664|-34.109|0.0581
71670804|NCT01709500|142859121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|240.6|||<|0.0001|TWO_SIDED|95.0|31.4|1841.7||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.||1841.7|31.4|<0.0001
71670805|NCT01709500|142859122|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-20.3|||<|0.0001|TWO_SIDED|95.0|-26.4|-14.2||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-14.2|-26.4|<0.0001
71670806|NCT01709500|142859123|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8|||=|0.0009|TWO_SIDED|95.0|2.8|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||10.7|2.8|= 0.0009
71754510|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.829|TWO_SIDED|95.0|-0.55|0.68||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.68|-0.55|0.829
71670807|NCT01709500|142859124|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.9|||=|0.0012|TWO_SIDED|95.0|-17.5|-4.3||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.||-4.3|-17.5|= 0.0012
71754511|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.713|TWO_SIDED|95.0|-0.5|0.74||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.74|-0.50|0.713
71754512|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.878|TWO_SIDED|95.0|-0.58|0.67||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.||0.67|-0.58|0.878
71754513|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.447|TWO_SIDED|95.0|-0.38|0.85||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.85|-0.38|0.447
71754514|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.511|TWO_SIDED|95.0|-0.41|0.83||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.83|-0.41|0.511
71754515|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.924|TWO_SIDED|95.0|-0.65|0.59||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.||0.59|-0.65|0.924
71787494|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.211||||90.0|-0.197|0.497|||ANCOVA|||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.497|-0.197|
71787495|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.16|0.492|||ANCOVA|||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.492|-0.160|
71787496|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.208||||90.0|-0.274|0.411|||ANCOVA|||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.411|-0.274|
71787497|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.252||||90.0|-0.876|-0.043|||ANCOVA|||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-0.876|
71787498|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.579|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.986|-0.172|||ANCOVA|||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.172|-0.986|
71670808|NCT01709500|142859125|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4|||=|0.0062|TWO_SIDED|95.0|1.3|7.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.5|1.3|= 0.0062
71670809|NCT01709500|142859126|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.1|||<|0.0001|TWO_SIDED|95.0|-25.0|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-13.1|-25|<0.0001
71670810|NCT01709500|142859127|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|||=|0.0147|TWO_SIDED|95.0|0.9|7.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||7.8|0.9|= 0.0147
71670811|NCT01709500|142859128|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.6|||=|0.024|TWO_SIDED|95.0|-16.1|-1.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.||-1.1|-16.1|= 0.024
71670812|NCT01709500|142859129|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3|||=|0.1475|TWO_SIDED|95.0|-0.8|5.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).||5.5|-0.8|= 0.1475
71670813|NCT01609790|142859131|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Z-test|One-sided test, significance level 0.15||Assuming a 36% 6-month (6m) rate in the placebo arm \[from the March 2009 Food and Drug Administration (FDA) briefing\], a 55% rate in the AMG 386 arm, and an exponential distribution corresponds to median PFS of 4.1 and 7 months, respectively, with a hazard ratio of 0.59 (AMG 386 arm vs. placebo arm). A total of 114 patients (57 per arm) will yield 85% power to detect an absolute 19% difference of 6m PFS rate at a 1-sided alpha level of 0.15 based on a 2-sample proportion test.||||0.98
71670814|NCT01609790|142859132|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|||||||Chi-squared|||||||0.85
71787499|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.255||||90.0|-0.88|-0.04|||ANCOVA|||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.040|-0.880|
71787500|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.385|STANDARD_ERROR_OF_MEAN|0.265||||90.0|-0.822|0.053|||ANCOVA|||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.053|-0.822|
71787501|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.268||||90.0|-1.372|-0.487|||ANCOVA|||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.487|-1.372|
71670815|NCT01609790|142859133|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.46||||0.09|TWO_SIDED|95.0|0.95|2.27|||Log Rank|||||2.27|0.95|0.09
71670816|NCT01609790|142859134|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.51||||0.04|TWO_SIDED|95.0|1.02|2.24|||Log Rank|||||2.24|1.02|0.04
71787502|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.823|STANDARD_ERROR_OF_MEAN|0.286||||90.0|-1.296|-0.351|||ANCOVA|||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.351|-1.296|
71787503|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.525|STANDARD_ERROR_OF_MEAN|0.267||||90.0|-0.965|-0.084|||ANCOVA|||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.084|-0.965|
71837151|NCT03683719|143180907|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.05||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.05
71670817|NCT01609790|142859135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Chi-squared|||||||0.7
71670818|NCT03190993|142859194|OTHER|Linear mixed effect models were used to test if changes (Day 28 - Baseline) were equal between treatment groups (primary outcome).|Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.43|=|0.22|TWO_SIDED||||||Regression, Linear|||||||=0.22
71670819|NCT03588910|142859198|SUPERIORITY|Wilcoxon rank-sum tests||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||.87
71670820|NCT03588910|142859199|SUPERIORITY|Wilcoxon rank-sum tests||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||.36
71670821|NCT03588910|142859200|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||.91
71670822|NCT03588910|142859201|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
71670823|NCT03588910|142859202|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||.36
71670824|NCT01108718|142859247|SUPERIORITY_OR_OTHER||Rate of Preference|0.45|STANDARD_DEVIATION|0.5|>|0.1|TWO_SIDED|95.0|0.43|0.47|||McNemar||Rate of preference refers specifically to Tempur-Pedic Mattress.|h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress||.47|.43|>0.1
71670825|NCT00806403|142859259|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Fisher Exact|||Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.||||0.56
71670826|NCT00806403|142859260|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71787504|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|STANDARD_ERROR_OF_MEAN|0.276||||90.0|-1.104|-0.191|||ANCOVA|||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.191|-1.104|
71787505|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.853|STANDARD_ERROR_OF_MEAN|0.295||||90.0|-1.34|-0.367|||ANCOVA|||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.367|-1.340|
71787506|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.303||||90.0|-0.89|0.111|||ANCOVA|||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.111|-0.890|
71787507|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.636|STANDARD_ERROR_OF_MEAN|0.293||||90.0|-1.119|-0.153|||ANCOVA|||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.153|-1.119|
71787508|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.522|STANDARD_ERROR_OF_MEAN|0.29||||90.0|-1.0|-0.043|||ANCOVA|||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.043|-1.000|
71787509|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.744|STANDARD_ERROR_OF_MEAN|0.346||||90.0|-1.315|-0.173|||ANCOVA|||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.173|-1.315|
71787510|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.378|STANDARD_ERROR_OF_MEAN|0.628||||90.0|-2.42|-0.335|||ANCOVA|||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.335|-2.420|
71787511|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-1.183|-0.258|||ANCOVA|||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||-0.258|-1.183|
71787512|NCT00137046|143072827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.323||||90.0|-0.594|0.472|||ANCOVA|||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.||0.472|-0.594|
71787513|NCT02725710|143072836|OTHER|||||||0.56|||||||Regression, Linear|||||||0.56
71787514|NCT03978520|143072867|SUPERIORITY||Response Rate Difference|12.8|||=|0.081|TWO_SIDED|95.0|-1.6|27.1|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||27.1|-1.6|=0.081
71787515|NCT03978520|143072867|SUPERIORITY||Response Rate Difference|16.9|||=|0.028|TWO_SIDED|95.0|1.8|31.9|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||31.9|1.8|=0.028
71787516|NCT03978520|143072867|SUPERIORITY||Response Rate Difference|-4.7|||=|0.566|TWO_SIDED|95.0|-20.8|11.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||11.4|-20.8|=0.566
71787517|NCT03978520|143072868|SUPERIORITY||Response Rate Difference|18.3|||=|0.013|TWO_SIDED|95.0|3.9|32.6|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||32.6|3.9|=0.013
71787518|NCT03978520|143072868|SUPERIORITY||Response Rate Difference|18.1|||=|0.018|TWO_SIDED|95.0|3.0|33.2|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||33.2|3.0|=0.018
71813223|NCT03152084|143128846|OTHER|Within-group change|Least square mean|344.85|||<|0.0001|TWO_SIDED|95.0|272.785|416.905||Start of treatment vs baseline|Mixed Models Analysis|||||416.905|272.785|<0.0001
71892052|NCT02115308|143305601|SUPERIORITY||||||<|0|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||<0.000
71670827|NCT00806403|142859261|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.||||0.04
71787519|NCT03978520|143072868|SUPERIORITY||Response Rate Difference|-1.2|||=|0.882|TWO_SIDED|95.0|-17.6|15.2|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||15.2|-17.6|=0.882
71787520|NCT03978520|143072869|SUPERIORITY||Response Rate Difference|14.7|||=|0.049|TWO_SIDED|95.0|0.0|29.4|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||29.4|0.0|=0.049
71787521|NCT03978520|143072869|SUPERIORITY||Response Rate Difference|13.9|||=|0.091|TWO_SIDED|95.0|-2.2|30.1|||Cochran-Mantel-Haenszel|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||30.1|-2.2|=0.091
71787522|NCT03978520|143072869|SUPERIORITY||Response Rate Difference|-6.3|||=|0.447|TWO_SIDED|95.0|-22.5|9.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||9.9|-22.5|=0.447
71787523|NCT03978520|143072870|SUPERIORITY||Response Rate Difference|16.7|||=|0.007|TWO_SIDED|95.0|4.5|28.9|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||28.9|4.5|=0.007
71787524|NCT03978520|143072870|SUPERIORITY||Response Rate Difference|31.0|||<|0.001|TWO_SIDED|95.0|18.1|44.0|||Cochran-Mantel-Haenszel|||Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo||44.0|18.1|<0.001
71787525|NCT03978520|143072870|SUPERIORITY||Response Rate Difference|-13.7|||=|0.068|TWO_SIDED|95.0|-28.4|1.0|||Cochran-Mantel-Haenszel|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The difference between the groups was assessed using the Cochran-Mantel-Haenszel (CMH) test, stratified by baseline corticosteroid dose above 10 mg prednisone-equivalent (≤10 mg or \> 10 mg), screening SLEDAI-2K (\< 10 or ≥10), baseline interferon score (high or low or NA), baseline immunosuppressant (azathioprine, tacrolimus, cyclosporine, methotrexate \[MTX\], mycophenolate) (yes or no)."||1.0|-28.4|=0.068
71813224|NCT03152084|143128847|OTHER|Within-group change|Least square mean|311.3|||<|0.0001|TWO_SIDED|95.0|224.528|398.064||End of treatment vs baseline|Mixed Models Analysis|||||398.064|224.528|<0.0001
71754516|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.185|TWO_SIDED|95.0|-0.2|1.06||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||1.06|-0.20|0.185
71813225|NCT03152084|143128848|OTHER|Within-group change|Least square mean|-203.07|||<|0.0001|TWO_SIDED|95.0|-235.983|-170.162||Follow-up vs end of treatment|Regression, Linear|||||-170.162|-235.983|<0.0001
71813226|NCT03152084|143128849|OTHER|Within-group change|Least square mean|-5.2658||||0.0047|TWO_SIDED|95.0|-8.5459|-1.9856||Start of treatment vs baseline|Mixed Models Analysis|||||-1.9856|-8.5459|0.0047
71670828|NCT00806403|142859262|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.50
71813227|NCT03152084|143128850|OTHER|Within-group change|Least square mean|-7.0987||||0.0003|TWO_SIDED|95.0|-10.0379|-4.1595||End of treatment vs baseline|Mixed Models Analysis|||||-4.1595|-10.0379|0.0003
71813228|NCT03152084|143128851|OTHER|Within-group change|Least square mean|0.7287||||0.5592|TWO_SIDED|95.0|-1.9894|3.4468||Follow-up vs end of treatment|Regression, Linear|||||3.4468|-1.9894|0.5592
71670829|NCT00806403|142859263|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||||||0.21
71754517|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.403|TWO_SIDED|95.0|-0.37|0.91||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.91|-0.37|0.403
71754518|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.636|TWO_SIDED|95.0|-0.79|0.49||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.||0.49|-0.79|0.636
71670830|NCT01597778|142859279|SUPERIORITY||Difference in Kaplan-Meier estimates|6.1||||0.4092|TWO_SIDED|95.0|-5.2|17.4||Statistical significance was determined using a pre-specified threshold of 0.05. Final p-value is adjusted for the interim looks per study design.|Z-test to compare the Kaplan-Meier Est.|||The primary null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM.||17.4|-5.2|0.4092
71670831|NCT01597778|142859279|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.06|TWO_SIDED|95.0|0.99|1.7||Statistical significance was determined using a pre-specified threshold of 0.05|Regression, Cox|||The null hypothesis of the study is that there is no difference between the 2 year PFS probabilities for dUCB vs. haplo-BM after adjustment for age, performance score, and disease type.||1.70|0.99|0.060
71670832|NCT01597778|142859281|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before neutrophil recovery is competing risk.||The null hypothesis is that there is no difference between the neutrophil engraftment post-transplantation for dUCB vs. haplo-BM.||||0.046
71754519|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.304|TWO_SIDED|95.0|-0.3|0.95||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.95|-0.30|0.304
71754520|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.295|TWO_SIDED|95.0|-0.29|0.97||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.97|-0.29|0.295
71754521|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.975|TWO_SIDED|95.0|-0.62|0.64||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.||0.64|-0.62|0.975
71754522|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.349|TWO_SIDED|95.0|-0.33|0.93||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.93|-0.33|0.349
71892053|NCT02115308|143305601|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.172
71892054|NCT02115308|143305601|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change||||0.957
71670833|NCT01597778|142859282|SUPERIORITY|||||||0.16||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 20k post-transplantation for dUCB vs. haplo-BM.||||0.160
71670834|NCT01597778|142859282|SUPERIORITY|||||||0.146||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before Platelet recovery is competing risk.||The null hypothesis is that there is no difference between the platelet engraftment to 50k post-transplantation for dUCB vs. haplo-BM.||||0.146
71754523|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.351|TWO_SIDED|95.0|-0.34|0.94||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.94|-0.34|0.351
71813229|NCT03152084|143128852|OTHER|Within-group change|Least square mean|0.0315||||0.9288|TWO_SIDED|95.0|-0.7274|0.7904||Start of treatment vs baseline|Mixed Models Analysis|||||0.7904|-0.7274|0.9288
71813230|NCT03152084|143128853|OTHER|Within-group change|Least square mean|-0.4318||||0.1659|TWO_SIDED|95.0|-1.0761|0.2125||End of treatment vs baseline|Mixed Models Analysis|||||0.2125|-1.0761|0.1659
71813231|NCT03152084|143128854|OTHER|Within-group change|Least square mean|0.4755||||0.019|TWO_SIDED|95.0|0.0963|0.8548||Follow-up vs end of treatment|Regression, Linear|||||0.8548|0.0963|0.0190
71813232|NCT03152084|143128855|OTHER|Within-group change|Least square mean|-0.6713||||0.0157|TWO_SIDED|95.0|-1.1914|-0.1511||Start of treatment vs baseline|Mixed Models Analysis|||||-0.1511|-1.1914|0.0157
71813233|NCT03152084|143128856|OTHER|Within-group change|Least square mean|-0.0324||||0.87|TWO_SIDED|95.0|-0.4631|0.3984||End of treatment vs baseline|Mixed Models Analysis|||||0.3984|-0.4631|0.8700
71754524|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.992|TWO_SIDED|95.0|-0.64|0.65||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.||0.65|-0.64|0.992
71787526|NCT03978520|143072871|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.527|=|0.71|TWO_SIDED|95.0|-0.84|1.23|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.23|-0.84|=0.710
71787527|NCT03978520|143072871|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.545|=|0.963|TWO_SIDED|95.0|-1.05|1.1|||Mixed-effect model repeat measurement|||"Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.10|-1.05|=0.963
71670835|NCT01597778|142859284|SUPERIORITY|||||||0.693||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before 2nd graft failure is competing risk.||The null hypothesis is that there is no difference between the secondary graft failure probabilities post-transplantation for dUCB vs. haplo-BM.||||0.693
71670836|NCT01597778|142859285|SUPERIORITY|||||||0.142||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade II - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.142
71787528|NCT03978520|143072871|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.547|=|0.754|TWO_SIDED|95.0|-0.9|1.25|||Mixed-effect model repeat measurement|||"ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~The Mixed-Effect Model Repeat Measurement model included fixed effects of Tx, visit and Tx-by-visit interaction, stratification factors (Baseline corticosteroid dose \> 10 mg prednisone-equivalent (≤ 10 mg or \>10 mg), screening SLEDAI-2K (\<10 or ≥ 10), baseline interferon score (high/low/NA, baseline immunosuppressant (yes/no)), and continuous fixed covariates of measurements at Baseline."||1.25|-0.90|=0.754
71787529|NCT03978520|143072872|SUPERIORITY||Rate difference|-1.06|||=|0.002|TWO_SIDED|95.0|-1.74|-0.39|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs Elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.39|-1.74|=0.002
71787530|NCT03978520|143072872|SUPERIORITY||Rate Difference|-0.69|||=|0.059|TWO_SIDED|95.0|-1.41|0.03|||Binomial regression|||"Mild/Moderate~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.03|-1.41|=0.059
71787531|NCT03978520|143072872|SUPERIORITY||Rate Difference|-0.37|||=|0.252|TWO_SIDED|95.0|-1.01|0.27|||Binomial regression|||"Mild/Moderate~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.27|-1.01|=0.252
71787532|NCT03978520|143072872|SUPERIORITY||Rate Difference|-0.1|||=|0.467|TWO_SIDED|95.0|-0.37|0.17|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.17|-0.37|=0.467
71787533|NCT03978520|143072872|SUPERIORITY||Rate Difference|-0.26|||=|0.033|TWO_SIDED|95.0|-0.49|-0.02|||Binomial regression|||"Severe~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.02|-0.49|=0.033
71787534|NCT03978520|143072872|SUPERIORITY||Rate Difference|0.15|||=|0.156|TWO_SIDED|95.0|-0.06|0.37|||Binomial regression|||"Severe~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.37|-0.06|=0.156
71787535|NCT03978520|143072872|SUPERIORITY||Rate Difference|-1.16|||=|0.002|TWO_SIDED|95.0|-1.89|-0.44|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.44|-1.89|=0.002
71787536|NCT03978520|143072872|SUPERIORITY||Rate Difference|-0.95|||=|0.014|TWO_SIDED|95.0|-1.7|-0.19|||Binomial regression|||"Overall~Elsubrutinib placebo/upadacitinib 30 mg vs elsubrutinib placebo/upadacitinib placebo~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||-0.19|-1.70|=0.014
71787537|NCT03978520|143072872|SUPERIORITY||Rate Difference|-0.22|||=|0.526|TWO_SIDED|95.0|-0.89|0.46|||Binomial regression|||"Overall~ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) vs elsubrutinib placebo/upadacitinib 30 mg~A negative binomial regression model was used to assess treatment effect with treatment, visit, and stratification factors as covariates."||0.46|-0.89|=0.526
71787538|NCT01648205|143072877|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_DEVIATION|26.8||0.7958|TWO_SIDED|95.0|-14.1|11.0|||t-test, 2 sided|Paired t-test was used||||11.0|-14.1|0.7958
71670837|NCT01597778|142859285|SUPERIORITY|||||||0.604||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to aGVHD is competing risk.||The null hypothesis is that there is no difference between the aGVHD grade III - IV probabilities post-transplantation for dUCB vs. haplo-BM.||||0.604
71670838|NCT01597778|142859286|SUPERIORITY|||||||0.361||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death before cGVHD is competing risk.||The null hypothesis is that there is no difference between the cGVHD probabilities post-transplantation for dUCB vs. haplo-BM.||||0.361
71754525|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.681|TWO_SIDED|95.0|-0.5|0.77||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.77|-0.50|0.681
71670839|NCT01597778|142859287|SUPERIORITY|||||||0.0373||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-randomization for dUCB vs. haplo-BM.||||0.0373
71754526|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.569|TWO_SIDED|95.0|-0.46|0.83||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.83|-0.46|0.569
71670840|NCT01597778|142859287|SUPERIORITY|||||||0.0235||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference between the OS probabilities at year 2 post-transplant for dUCB vs. haplo-BM.||||0.0235
71754527|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.871|TWO_SIDED|95.0|-0.6|0.7||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.||0.70|-0.60|0.871
71754528|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.675|TWO_SIDED|95.0|-0.5|0.78||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.78|-0.50|0.675
71754529|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.823|TWO_SIDED|95.0|-0.57|0.72||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.72|-0.57|0.823
71787539|NCT01648205|143072878|SUPERIORITY||Median Difference (Final Values)|8.4|STANDARD_DEVIATION|35.9||0.3369|TWO_SIDED|95.0|-9.5|26.2|||t-test, 2 sided|Paired t-test was used||||26.2|-9.5|0.3369
71787540|NCT01414010|143072879|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||"Statistical analysis was performed using a variety of computer packages including XLstat, NCSS 2007, R and NCSS 2010"||||<0.05
71787541|NCT02142959|143072887|SUPERIORITY||LS Mean Difference Final Values|-0.1||||0.237|TWO_SIDED|65.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factors: treatment grp \& wk of visit; covariates of site, smoking status \& surgery. Missing data imputed using each patient's worst-observation.||Comparison of omaveloxolone lotion pooled (0.5% and 3%) versus vehicle lotion||0.0|-0.2|0.237
71787542|NCT02142959|143072887|SUPERIORITY||LS Mean Difference Final Values|-0.1|||>|0.05|TWO_SIDED|95.0|-0.2|0.0||Omaveloxolone treatment arms were compared with Vehicle Lotion using a hierarchical testing strategy to control the overall type I error.|Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 0.5% versus Vehicle Lotion||0.0|-0.2|>0.05
71787543|NCT02142959|143072887|SUPERIORITY||LS Mean Difference Final Values|0.0|||>|0.05|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|Fixed factor: treatment grp \& visit wk; Covariates: site, smoking status \& breast surgery. Missing data imputed using each patient's worst-observation||Comparison of Omaveloxolone Lotion 3% versus Vehicle Lotion||0.1|-0.1|>0.05
71813234|NCT03152084|143128857|OTHER|Within-group change|Least square mean|0.1718||||0.2446|TWO_SIDED|95.0|-0.1358|0.4795||Follow-up vs end of treatment|Regression, Linear|||||0.4795|-0.1358|0.2446
71813235|NCT03152084|143128858|OTHER|Within-group change|Least square mean|-2.1||||0.0023|TWO_SIDED|95.0|-3.299|-0.902||Start of treatment vs baseline|Mixed Models Analysis|||||-0.902|-3.299|0.0023
71813236|NCT03152084|143128858|OTHER|Within-group change|Least square mean|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.929|-1.256||End of treatment vs baseline|Mixed Models Analysis|||||-1.256|-1.929|<0.0001
71787544|NCT06092710|143072971|OTHER|Then, to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.||||||0.05572|||||||Kruskal-Wallis|||Non-parametric tests on patient sensitivity, given the non-normal distribution, (based on the median of the data) were applied to analyse the diﬀerences between the groups (ST1+ ST2 according to the STATUS3 and STATUS4 classification criteria). To analyse any diﬀerences in sensitivity between patient groups, Kruskal-Wallis tests were applied. In this type of analysis, having a p-value greater than 1% and ideally greater than 5% would indicate the absence of diﬀerences between groups.||||0.05572
71787545|NCT06092710|143072971|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected.|||||<|8e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000008
71787546|NCT06092710|143072971|OTHER|Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.|||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|||to see if the median of a particular group is diﬀerent from 0 (= no sensitivity: not feeling the diﬀerences in airflow induced by the diﬀerent tests given by the operator), Wilcoxon tests were performed on each group of data. If the p-value is small (less than 5%, ideally less than 1%), the null hypothesis that the score is identical to 0 is rejected. In this case, it means that the patients in the test group feel the diﬀerences in airflow depending on their position.||||<0.0000001
71670841|NCT01597778|142859288|SUPERIORITY|||||||0.039||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-randomization for dUCB vs. haplo-BM.||||0.039
71754530|NCT00385671|143011923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.85|TWO_SIDED|95.0|-0.72|0.59||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\*Week+ Baseline\*Week+Subgroup\*Week+Subgroup\*Treatment+Subgroup\*Treatment\*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.||0.59|-0.72|0.850
71754531|NCT00385671|143011925|SUPERIORITY_OR_OTHER|||||||0.448||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.448
71787547|NCT06092710|143072972|SUPERIORITY|||||||1.06e-06||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||Parametric tests on the prediction of patients' pathological status with SFI (Intermediate Final Score) For these analyses, as the SFI score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another.||||0.00000106
71787548|NCT06092710|143072972|SUPERIORITY|||||||48||||||Confidence level used: 0.95 Tukey multiple comparisons of means (95% family-wise confidence level)|ANOVA|||"Parametric tests on the prediction of patients' pathological status with SFT score (Final Total score):~For these analyses, as SFT score follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value, a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0000000048
71787549|NCT06092710|143072972|SUPERIORITY||Odds Ratio (OR)|8.73||||7.7e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFI:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000077
71787550|NCT06092710|143072972|SUPERIORITY||Odds Ratio (OR)|9.37||||6.9e-07|TWO_SIDED||||||Fisher Exact|||"Determination of cut-oﬀ values for SFT:~The Cutoﬀ\_final txt file includes the various sensitivity and specificity calculations as well as the Youden index in order to determine the best cut-oﬀ value (largest Youden). The ROC curves allow the values in the file to be appreciated graphically."||||0.00000069
71787551|NCT06092710|143072973|SUPERIORITY|||||||0.0142266|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0142266
71787552|NCT06092710|143072973|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
71787553|NCT06092710|143072973|SUPERIORITY|||||||0.0023308|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.0023308
71754532|NCT00385671|143011925|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.118
71754533|NCT00385671|143011925|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.||||0.021
71754534|NCT00385671|143011925|SUPERIORITY_OR_OTHER|||||||0.537||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.537
71754535|NCT00385671|143011925|SUPERIORITY_OR_OTHER|||||||0.911||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.911
71754536|NCT00385671|143011925|SUPERIORITY_OR_OTHER|||||||0.627||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.||||0.627
71754537|NCT00385671|143011926|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.078
71670842|NCT01597778|142859288|SUPERIORITY|||||||0.03||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality across the two treatment groups.||The null hypothesis is that there is no difference between the TRM probabilities post-transplantation for dUCB vs. haplo-BM||||0.030
71754538|NCT00385671|143011926|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.130
71754539|NCT00385671|143011926|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.||||0.850
71754540|NCT00385671|143011927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
71754541|NCT00385671|143011927|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.||||<0.001
71787554|NCT06092710|143072973|SUPERIORITY|||||||0.9915779|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9915779
71787555|NCT06092710|143072973|SUPERIORITY|||||||0.9999943|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9999943
71813237|NCT03152084|143128858|OTHER|Within-group change|Least square mean|3.88||||0.0002|TWO_SIDED|95.0|2.215|5.553||Follow-up vs end of treatment|Regression, Linear|||||5.553|2.215|0.0002
71754542|NCT00385671|143011927|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\*Week+Baseline\*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.||||0.011
71754543|NCT00385671|143011928|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||0.830
71787556|NCT06092710|143072973|SUPERIORITY|||||||0.9905111|||||||TUKEY TEST|||"Parametric tests on the prediction of patients' pathological status (SFI and SFT scores):~For these analyses, as the SFI and SFT scores follow a normal distribution, ANOVAs (analyses of variance) were performed. For discrete variables with more than 2 levels of value (STATUS4), a post-hoc 2-to-2 comparison analysis was performed (Tukey) to see which level of the variable diﬀered from one another."||||0.9905111
71787557|NCT03789318|143072974|SUPERIORITY|||||||0.2912|||||||ANOVA|||||||0.2912
71787558|NCT03789318|143072975|SUPERIORITY|||||||0.498|||||||ANOVA|||||||0.4980
71787559|NCT03789318|143072976|SUPERIORITY|||||||0.1958|||||||Log Rank|||||||0.1958
71787560|NCT03789318|143072977|SUPERIORITY|||||||0.9546|||||||Regression, Logistic|||||||0.9546
71787561|NCT03789318|143072978|SUPERIORITY|||||||0.4434|||||||ANOVA|||||||0.4434
71787562|NCT03700671|143072979|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||A P-value of 0.05 was used as the threshold for significance|ANOVA|||A sample size of 38 using G\*Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and moderate intensity continuous training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at = 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study||||<0.01
71787563|NCT03700671|143072980|SUPERIORITY||||||<|0.01|TWO_SIDED|95.0||||0.05 was used as a threshold for significance|ANOVA|||||||<0.01
71670843|NCT01597778|142859289|SUPERIORITY|||||||0.968||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post-randomization for dUCB vs. haplo-BM.||||0.968
71787564|NCT01774968|143072983|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.1||||0.3709|TWO_SIDED|95.0|-0.33|0.12|||Mixed Models Analysis|||Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.||0.12|-0.33|0.3709
71787565|NCT02044393|143072998|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.07|STANDARD_ERROR_OF_MEAN|32.1|||TWO_SIDED|90.0|62.371|87.959|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 69175 treatment (in plasma)||87.959|62.371|
71787566|NCT02044393|143072998|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|86.35|STANDARD_ERROR_OF_MEAN|18.6|||TWO_SIDED|90.0|78.04|95.56|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||95.56|78.04|
71787567|NCT02044393|143072999|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|95.59|STANDARD_ERROR_OF_MEAN|23.5|||TWO_SIDED|90.0|84.195|108.537|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in plasma)||108.537|84.195|
71787568|NCT02044393|143072999|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|93.54|STANDARD_ERROR_OF_MEAN|15.1|||TWO_SIDED|90.0|86.142|101.57|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in whole blood)||101.570|86.142|
71787569|NCT02044393|143073000|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.86|STANDARD_ERROR_OF_MEAN|32.4|||TWO_SIDED|90.0|62.946|89.035|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in plasma)||89.035|62.946|
71787570|NCT02044393|143073000|NON_INFERIORITY_OR_EQUIVALENCE|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|88.19|STANDARD_ERROR_OF_MEAN|20.7|||TWO_SIDED|90.0|78.6|98.95|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)||98.95|78.60|
71670844|NCT01597778|142859289|SUPERIORITY|||||||0.907||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|Estimate cumulative incidence functions from competing risks data and test equality of 2 trt grps. Death prior to relapse is competing risk.||The null hypothesis is that there is no difference between the relapse/progression probabilities post- transplantation for dUCB vs. haplo-BM.||||0.907
71754544|NCT00385671|143011928|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
71754545|NCT00385671|143011928|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.||||1.00
71754546|NCT00385671|143011928|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.060
71754547|NCT00385671|143011928|SUPERIORITY_OR_OTHER|||||||0.502||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.502
71754548|NCT00385671|143011928|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.||||0.376
71754549|NCT00385671|143011929|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.281
71754550|NCT00385671|143011929|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.060
71754551|NCT00385671|143011929|SUPERIORITY_OR_OTHER|||||||0.596||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.||||0.596
71670845|NCT01597778|142859292|SUPERIORITY|||||||0.0003||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference between the total duration of hospitalization within 6 months post-randomization for dUCB vs. haplo-BM.||||0.0003
71754552|NCT00385671|143011930|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.332
71787571|NCT02345850|143073008|SUPERIORITY||Hazard Ratio (HR)|0.805||||0.2368|TWO_SIDED|95.0|0.562|1.154||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Tac/MTX Control. The data in primary outcome table provides point estimates at specific time points (1 year and 2 years post randomization). The statistics in this session provides comparisons between different arms for the entire period of the study.||1.154|0.562|0.2368
71787572|NCT02345850|143073008|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.4134|TWO_SIDED|95.0|0.609|1.228||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.228|0.609|0.4134
71754553|NCT00385671|143011930|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.||||0.065
71754554|NCT00385671|143011930|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.||||0.622
71670846|NCT04740918|142859338|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (estrogen receptors (ER) and/or progesterone receptor (PgR) positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the Hazard Ratio (HR).|Hazard Ratio (HR)|0.75||||0.2876|TWO_SIDED|95.0|0.44|1.28|||Log Rank|||||1.28|0.44|0.2876
71670847|NCT04740918|142859339|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.59||||0.5151|TWO_SIDED|95.0|0.39|6.43|||Log Rank|||||6.43|0.39|0.5151
71670848|NCT04740918|142859340|SUPERIORITY|A Cochran-Mantel-Haenszel chi-square test, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis), was used to test for difference in response rates.|Odds Ratio (OR)|1.16||||0.724|TWO_SIDED|95.0|0.5|2.7|||Cochran-Mantel-Haenszel|||||2.70|0.50|0.7240
71670849|NCT04740918|142859341|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|0.65||||0.3531|TWO_SIDED|95.0|0.26|1.61|||Log Rank|||||1.61|0.26|0.3531
71670850|NCT04740918|142859342|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.35||||0.7175|TWO_SIDED|95.0|0.27|6.81|||Log Rank|||||6.81|0.27|0.7175
71754555|NCT00385671|143011930|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.103
71754556|NCT00385671|143011930|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.||||0.034
71754557|NCT00385671|143011930|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.||||0.808
71787573|NCT02345850|143073008|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.7166|TWO_SIDED|95.0|0.643|1.355||The primary pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The primary null hypothesis of the study is that there is no difference of the CRFS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||1.355|0.643|0.7166
71787574|NCT02345850|143073008|SUPERIORITY|||||||0.386||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the CRFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk. The data in primary outcome table provides point estimates. The statistics in this session provides comparisons between different arms for the entire period of the study.||||0.386
71787575|NCT02345850|143073008|SUPERIORITY|||||||0.461||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and disease risk (Low/Intermediate vs. High) for CRFS.||||0.461
71787576|NCT02345850|143073008|SUPERIORITY|||||||0.115||||||Cox proportional hazards regression|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Age (\<=50 vs. \>50) for CRFS.||||0.115
71837152|NCT03683719|143180907|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||>|0.1||||||"IGA-CHE TS was reached in less than 50% of participants, therefore the median time was not estimable.~The statistical test was not controlled for multiplicity."|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||>0.1
71754558|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.055
71787577|NCT02345850|143073008|SUPERIORITY|||||||0.227||||||A Bonferroni adjusted significance level of 0.05/3=0.0167 is used for each of three interaction tests to account for multiple testing.|Cox proportional hazards regression|||Subgroup analyses are conducted for CRFS according to disease, disease risk and age. Interaction tests between treatment group and subgroup are conducted within a Cox proportional hazards regression model with treatment, subgroup, and a treatment\*subgroup interaction term. The null hypothesis is that there is no Interaction between treatment group and Disease (AML vs. ALL vs. MDS) for CRFS.||||0.227
71787578|NCT02345850|143073009|SUPERIORITY||Hazard Ratio (HR)|1.744||||0.0197|TWO_SIDED|95.0|1.086|2.8||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Tac/MTX Control.||2.800|1.086|0.0197
71787579|NCT02345850|143073009|SUPERIORITY||Hazard Ratio (HR)|1.016||||0.9525|TWO_SIDED|95.0|0.599|1.724||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between Post-Transplant Cyclophosphamide vs. Tac/MTX Control.||1.724|0.599|0.9525
71787580|NCT02345850|143073009|SUPERIORITY||Hazard Ratio (HR)|1.774||||0.0185|TWO_SIDED|95.0|1.093|2.877||The OS pairwise comparisons are tested at a Bonferroni adjusted significance level of 0.05/3.|Log Rank|||The null hypothesis is that there is no difference of the OS hazard ratio between CD34 select graft vs. Post-Transplant Cyclophosphamide.||2.877|1.093|0.0185
71787581|NCT02345850|143073009|SUPERIORITY|||||||0.026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the OS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.026
71787582|NCT02345850|143073010|SUPERIORITY|||||||0.029||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Relapse-Free Survival between the treatment groups.||||0.029
71787583|NCT02345850|143073010|SUPERIORITY|||||||0.145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the RFS hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.145
71787584|NCT02345850|143073011|SUPERIORITY|||||||0.02||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Transplant-Related Mortality between the treatment groups.||||0.020
71787585|NCT02345850|143073011|SUPERIORITY|||||||0.04||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the TRM hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.040
71787586|NCT02345850|143073012|SUPERIORITY|||||||0.2389||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Chi-squared|||The null hypothesis is that there is no difference of immunosuppression-free survival at 1-year post-transplant between the treatment groups.||||0.2389
71892055|NCT00642642|143305602|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||a priori threshold for statistical significance was 0.05|McNemar|Paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||0.0109
71787587|NCT02345850|143073012|SUPERIORITY||||||<|0.0001|||||||Cohen's Kappa|||The null hypothesis is that there is no agreement between CRFS and immunosuppression-free survival at 1-year post-transplant.||||<0.0001
71787588|NCT02345850|143073013|SUPERIORITY|||||||0.076||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Disease Relapse between the treatment groups.||||0.076
71787589|NCT02345850|143073013|SUPERIORITY|||||||0.106||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the Disease Relapse hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.106
71787590|NCT02345850|143073014|SUPERIORITY|||||||0.0764||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Neutrophil Engraftment post-transplantation between the treatment groups.||||0.0764
71787591|NCT02345850|143073015|SUPERIORITY|||||||0.0001||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Platelet recovery post-transplantation between the treatment groups.||||0.0001
71787592|NCT02345850|143073017|SUPERIORITY|||||||0.1478|||||||Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Secondary graft failure post-transplantation between the treatment groups.||||0.1478
71787593|NCT02345850|143073018|SUPERIORITY|||||||0.0026||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade II-IV acute GVHD post-transplantation between the treatment groups.||||0.0026
71787594|NCT02345850|143073018|SUPERIORITY|||||||0.0369||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of grade III-IV acute GVHD post-transplantation between the treatment groups.||||0.0369
71787595|NCT02345850|143073018|SUPERIORITY|||||||0.002||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade II-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.002
71787596|NCT02345850|143073018|SUPERIORITY|||||||0.046||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the grade III-IV acute GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.046
71754559|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.||||0.051
71754560|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.993||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.||||0.993
71754561|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.928||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.928
71754562|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.||||0.609
71754563|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.675||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.||||0.675
71754564|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.985
71754565|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.847||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.||||0.847
71754566|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.832||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.||||0.832
71754567|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.169
71754568|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.||||0.910
71754569|NCT00385671|143011931|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.||||0.134
71845558|NCT00357994|143205613|SUPERIORITY_OR_OTHER||Treament Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.1||0.1501|TWO_SIDED|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.||1.7|-10.7|0.1501
71754570|NCT00385671|143011932|SUPERIORITY_OR_OTHER|||||||0.285||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.||||0.285
71754571|NCT00385671|143011932|SUPERIORITY_OR_OTHER|||||||0.505||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.||||0.505
71754572|NCT00385671|143011932|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.||||0.679
71754573|NCT00385671|143011933|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.047
71754574|NCT00385671|143011933|SUPERIORITY_OR_OTHER|||||||0.232||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.232
71754575|NCT00385671|143011933|SUPERIORITY_OR_OTHER|||||||0.424||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.||||0.424
71754576|NCT00385671|143011934|SUPERIORITY_OR_OTHER|||||||0.298||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.298
71754577|NCT00385671|143011934|SUPERIORITY_OR_OTHER|||||||0.987||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.987
71754578|NCT00385671|143011934|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model \& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.||||0.297
71754579|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||1.00
71754580|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.749
71787597|NCT02345850|143073020|SUPERIORITY|||||||0.0024||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of chronic GVHD post-transplantation between the treatment groups.||||0.0024
71787598|NCT02345850|143073020|SUPERIORITY|||||||0.005||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Regression, Cox|||The null hypothesis is that there is no difference of the chronic GVHD hazard ratio between treatment groups after adjustment for age, donor type, performance status, primary disease, and disease risk.||||0.005
71787599|NCT02345850|143073021|SUPERIORITY|||||||0.229||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Log Rank|||The null hypothesis is that there is no difference of Chronic GVHD-free Survival post-transplantation between the treatment groups.||||0.229
71845559|NCT00357994|143205614|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.08|STANDARD_ERROR_OF_MEAN|0.45||0.8574|TWO_SIDED|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.82|-0.98|0.8574
71845560|NCT00357994|143205615|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-10.4|STANDARD_ERROR_OF_MEAN|4.3||0.0184|TWO_SIDED|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-1.8|-19.1|0.0184
71754581|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.||||0.750
71754582|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.050
71787600|NCT02345850|143073023|SUPERIORITY|||||||0.0006||||||Superiority - Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades II-III infection post-transplantation between the treatment groups.||||0.0006
71787601|NCT02345850|143073023|SUPERIORITY|||||||0.0145||||||Statistical significance was determined using a pre-specified threshold of 0.05.|Gray's test for cumulative Incidence|||The null hypothesis is that there is no difference of Grades III infection post-transplantation between the treatment groups.||||0.0145
71787602|NCT01991067|143073032|OTHER|Furthermore, a multivariable logistic regression model was applied accounting for group as well as age, body mass index, and gender as possible influence factors.|||||<|0.001||||||The threshold for statistical significance was a p-value of \<0.05.|Fisher Exact|||The calculation of the sample size was performed using nQuery 6.1. The primary endpoint was the outcome of the NT 4 weeks after the second vaccination. A Fisher exact tes was calculated to analyze the primary hypothesis on the difference in NT-titer response between patients and controls||||<0.001
71787603|NCT01991067|143073033|OTHER|||||||0.02|||||||Fisher Exact|||A Fisher exact test was calculated to analyze antibody response by ELISA between patients and controls. To measure the Agreement between the NT and ELISA response, Cohens Kappa and the corresponding 95% confidence interval were calculated||||0.02
71787604|NCT01991067|143073034|OTHER||||||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"For titer values the geometric mean was calculated and the corresponding two-sided 95% confidence intervals were constructed by back-transfomration of the CI for the mean of the logarithmically transformed results.~To investigate the difference in absolute titer values and geometric mean fold changes between time point and Groups, Wilcoxon tests were performed."||||<0.01
71787605|NCT01075204|143073043|SUPERIORITY_OR_OTHER|||||||0.334||95.0|||||Chi-squared|9 degrees of freedom.||Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).||||0.334
71787606|NCT02670083|143073055|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.354|||TWO_SIDED|95.0|-0.86|0.53||||||||0.53|-0.86|
71787607|NCT02670083|143073056|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|95.0|-2.39|1.87||||||||1.87|-2.39|
71787608|NCT02670083|143073057|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-2.08|1.88||||||||1.88|-2.08|
71787609|NCT02670083|143073058|SUPERIORITY||Least Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.076|||TWO_SIDED|95.0|-0.1|0.2||||||||0.20|-0.10|
71787610|NCT02670083|143073059|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.486|||TWO_SIDED|95.0|-0.62|1.29||||||||1.29|-0.62|
71787611|NCT02670083|143073060|SUPERIORITY||Least Squares Mean Difference|1.88|STANDARD_ERROR_OF_MEAN|1.679|||TWO_SIDED|95.0|-1.43|5.18||||||||5.18|-1.43|
71787612|NCT02670083|143073061|SUPERIORITY||Least Squares Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|1.306|||TWO_SIDED|95.0|-1.35|3.79||||||||3.79|-1.35|
71787613|NCT02670083|143073063|SUPERIORITY||Least Squares Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.723|||TWO_SIDED|95.0|-1.95|0.9||||||||0.90|-1.95|
71787614|NCT02670083|143073064|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|95.0|-0.81|1.6||||||||1.60|-0.81|
71787615|NCT02670083|143073065|SUPERIORITY||Least Squares Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|6.214|||TWO_SIDED|95.0|-13.64|10.86||||||||10.86|-13.64|
71787616|NCT02670083|143073066|SUPERIORITY||Least Squares Mean Difference|1.82|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.64|6.27||||||||6.27|-2.64|
71787617|NCT02670083|143073067|SUPERIORITY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|2.222|||TWO_SIDED|95.0|-3.45|5.32||||||||5.32|-3.45|
71787618|NCT02670083|143073073|SUPERIORITY||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.24|0.22||||||||0.22|-0.24|
71754583|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.320
71754584|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.||||0.440
71787619|NCT02670083|143073074|SUPERIORITY||Least Squares Mean Difference|-1.28|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-3.72|1.17||||||||1.17|-3.72|
71787620|NCT02670083|143073075|SUPERIORITY||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.1|0.89||||||||0.89|-0.10|
71787621|NCT02014597|143073077|OTHER|||||||0.0583||||||Scotopic logCS|Kruskal-Wallis|||||||0.0583
71787622|NCT02014597|143073077|OTHER|||||||0.1762||||||Photopic logCS|Kruskal-Wallis|||||||0.1762
71787623|NCT02014597|143073078|OTHER|||||||0.183||||||Scotopic|Pearson correlation|||Correlation between logCS and MD.||||0.183
71787624|NCT02014597|143073078|OTHER|||||||0.771||||||Photopic|Pearson correlation|||Correlation between logCS and MD.||||0.771
71787625|NCT02014597|143073078|OTHER|||||||0.492||||||Scotopic|Pearson correlation|||Correlation between logCS and PSD.||||0.492
71787626|NCT02014597|143073078|OTHER|||||||0.83||||||Photopic|Pearson correlation|||Correlation between logCS and PSD.||||0.830
71787627|NCT02057406|143073098|SUPERIORITY|The EPA/DHA arm versus placebo at Week 12.||||||0.74|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.74
71754585|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.498
71754586|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.245||95.0||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.||||0.245
71754587|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.160
71754588|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.||||0.280
71754589|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.||||1.00
71754590|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.023
71754591|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.264
71754592|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.||||0.325
71754593|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||1.00
71754594|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.121
71754595|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.||||0.095
71754596|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||1.00
71754597|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.720
71754598|NCT00385671|143011935|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.||||0.722
71754599|NCT04944992|143011936|SUPERIORITY||Difference in least squared means|30.4|||<|0.0001|TWO_SIDED|90.0|22.1|38.7|||Mixed Models Analysis|||||38.7|22.1|<0.0001
71754600|NCT04944992|143011937|OTHER|Difference (Efinopegdutide - Semaglutide) in %|difference in percentage|16.3||||||95.0|3.5|29.1||||||||29.1|3.5|
71754601|NCT04944992|143011938|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in percentage|5.6||||||95.0|0.4|13.5||||||||13.5|0.4|
71754602|NCT04944992|143011939|SUPERIORITY||Difference in least squared means|6.1|||<|0.001|TWO_SIDED|90.0|4.6|7.7|||Mixed Models Analysis|||||7.7|4.6|<0.001
71754603|NCT04944992|143011940|SUPERIORITY||Difference in Least Squared Means|-1.4||||0.085|TWO_SIDED|90.0|-2.7|-0.1|||Mixed Models Analysis|||||-0.1|-2.7|0.085
71670851|NCT04740918|142859343|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.||||||0.3173|||||||Log Rank|||||||0.3173
71670852|NCT04740918|142859344|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.19||||0.8658|TWO_SIDED|95.0|0.16|8.6|||Log Rank|||||8.60|0.16|0.8658
71754604|NCT04944992|143011941|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in Least Squared Means|-7.2|||||TWO_SIDED|90.0|-11.2|-3.1||||||||-3.1|-11.2|
71754605|NCT04944992|143011942|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.7||||||90.0|-10.9|-0.6||||||||-0.6|-10.9|
71754606|NCT04944992|143011943|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-11.7||||||90.0|-15.8|-7.7||||||||-7.7|-15.8|
71754607|NCT04944992|143011944|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-6.1||||||90.0|-12.0|-0.1||||||||-0.1|-12.0|
71754608|NCT04944992|143011945|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-7.6|||||TWO_SIDED|90.0|-14.3|-0.9||||||||-0.9|-14.3|
71754609|NCT04944992|143011946|OTHER|Difference (Efinopegdutide - Semaglutide) in %|Difference in least squared means|-5.4|||||TWO_SIDED|90.0|-10.4|-0.4||||||||-0.4|-10.4|
71787628|NCT02057406|143073098|SUPERIORITY|High EPA group versus placebo group at Week 12.||||||0.45|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.||||0.45
71787629|NCT02057406|143073099|SUPERIORITY|Active supplements (2:1 EPA/DHA and High EPA combined) versus placebo at Week 12.|||||<|0.0001|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||<0.0001
71787630|NCT02057406|143073099|SUPERIORITY|2:1 EPA/DHA versus High EPA at Week 12.||||||0.12|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.||||0.12
71787631|NCT02425046|143073100|SUPERIORITY|||||||0.67||||||Threshold for statistical significance \<0.05|t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||||||0.67
71837153|NCT03683719|143180907|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.0001||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.0001
71845561|NCT00357994|143205616|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-11.6|STANDARD_ERROR_OF_MEAN|4.5||0.0129|TWO_SIDED|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-2.5|-20.6|0.0129
71845562|NCT00357994|143205617|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-2.2|STANDARD_ERROR_OF_MEAN|3.4||0.5246|TWO_SIDED|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.6|-9.0|0.5246
71754610|NCT01295814|143011947|NON_INFERIORITY_OR_EQUIVALENCE|"The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.~The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12."|Mean Difference (Final Values)|7.9||||0.75|TWO_SIDED|95.0|4.0|11.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||11.8|4.0|0.75
71754611|NCT01295814|143011948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.99|TWO_SIDED|95.0|1.7|6.3||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||6.3|1.7|0.99
71845563|NCT00357994|143205618|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.5|STANDARD_ERROR_OF_MEAN|3.8||0.2423|TWO_SIDED|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||3.1|-12.0|0.2423
71754612|NCT01295814|143011949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.76|TWO_SIDED|95.0|2.1|5.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||5.8|2.1|0.76
71787632|NCT02425046|143073101|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||null hypothesis - there will be no difference between the groups.||||0.735
71787633|NCT02425046|143073102|SUPERIORITY|||||||0.599|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis that there would be no difference in change in FNPA scores between the two groups over 12 months.||||0.599
71754613|NCT01295814|143011950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.76|TWO_SIDED|95.0|2.6|10.0||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||10.0|2.6|0.76
71754614|NCT01295814|143011951|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided|||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.||||0.67
71754615|NCT03414983|143011952|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|80.0|0.61|1.07||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.07|0.61|0.3022
71754616|NCT03414983|143011952|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.3022|TWO_SIDED|95.0|0.53|1.23||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.23|0.53|0.3022
71754617|NCT03414983|143011953|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.19|||||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.19|0.54|
71754618|NCT03414983|143011968|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|80.0|0.67|1.15||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.15|0.67|0.5041
71754619|NCT03414983|143011968|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.5041|TWO_SIDED|95.0|0.58|1.32||Stratified regular log-rank test|Log Rank||Stratified Cox proportional hazard model|Hazard Ratio is Arm A: NIV+mFOLFOX+BEV over Arm B: mFOLFOX+BEV||1.32|0.58|0.5041
71787634|NCT02425046|143073103|SUPERIORITY|||||||0.583|||||||t-test, 2 sided|Multiple imputation used to fill in missing data - imputation included demographic and 6 month data. 5 datasets created and results averaged.||Null hypothesis: Change in MVPA from baseline to 12 months will not be different between target children in the two groups.||||0.583
71787635|NCT02425046|143073104|SUPERIORITY|||||||0.312|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||Null hypothesis is that there will be no difference between the two arms in change in sugar sweetened beverage intake over 12 months.||||0.312
71754620|NCT01428258|143012018|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-147.0|STANDARD_ERROR_OF_MEAN|39.0||0.0008|TWO_SIDED||||||ANCOVA|||||||0.0008
71787636|NCT02425046|143073105|SUPERIORITY||difference in change between two arms|75.0||||0.1|TWO_SIDED|95.0|-15.0|165.0|||Linear quantile mixed model|Linear quantile mixed models (a non-parametric linear mixed model) was used because of non-normal distribution that could not be transformed.|Comparison of the intervention target adult change in reported physical activity compared to the control group.|Linear quantile mixed models (a non-parametric linear mixed model) was used because because of non-normal distribution that could not be remedied by transformation.||165|-15|0.10
71787637|NCT02425046|143073106|SUPERIORITY||difference in change between two arms|-2.54||||0.057|TWO_SIDED|95.0|-5.14|0.07|||Mixed Models Analysis||The intervention arm in comparison to the control arm.|||0.07|-5.14|0.057
71787638|NCT02425046|143073107|SUPERIORITY|||||||0.874|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.874
71787639|NCT02425046|143073108|SUPERIORITY||% difference in change between arms|7.0||||0.31|TWO_SIDED|95.0|-7.0|23.0|||Mixed Models Analysis|Screen time was log transformed to normalized the distribution. Results have been back transformed from log 10 scale.|% change in screen time of the intervention arm compared to the control arm.|||23|-7|0.31
71670853|NCT04740918|142859345|SUPERIORITY|Cox proportional hazards model, stratified by local hormonal status (ER and/or PgR positive vs. ER and PgR negative/unknown) and Disease status (visceral metastasis without brain metastasis vs. non-visceral metastasis only without brain metastasis \[including locally advanced disease\] vs. Brain metastasis) were used to estimate the HR.|Hazard Ratio (HR)|1.16||||0.8407|TWO_SIDED|95.0|0.27|4.99|||Log Rank|||||4.99|0.27|0.8407
71754621|NCT01428258|143012018|OTHER|||||||0.136|||||||ANCOVA|||||||0.136
71787640|NCT02425046|143073109|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|Multiple imputation including demographics and 6 month data used to complete dataset. 5 datasets created and t-score averaged.||||||0.516
71787641|NCT02692716|143073118|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|< 0.0001
71754622|NCT01428258|143012018|OTHER|||||||0.044|||||||ANCOVA|||||||0.044
71754623|NCT01428258|143012019|OTHER|||||||0.576|||||||ANOVA|||||||0.576
71754624|NCT01428258|143012020|OTHER|||||||0.902|||||||t-test, 2 sided|||||||0.902
71754625|NCT01428258|143012021|OTHER|||||||0.797|||||||t-test, 2 sided|||||||0.797
71754626|NCT01428258|143012022|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
71754627|NCT00248625|143012026|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.19
71754628|NCT00248625|143012027|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
71754629|NCT00248625|143012028|SUPERIORITY_OR_OTHER|||||||0.21|||||||Pepe and Mori test of CIF difference|||||||0.21
71754630|NCT00248625|143012029|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Kruskal-Wallis|||||||0.053
71754631|NCT00248625|143012030|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Cochran-Armitage trend|||||||0.29
71754632|NCT00248625|143012031|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Armitage trend|||||||0.74
71754633|NCT00248625|143012032|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Cochran-Armitage tren|||||||0.54
71754634|NCT00248625|143012033|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Chi-squared|||||||0.86
71754635|NCT03085095|143012034|NON_INFERIORITY|The lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups was calculated with a noninferiority margin of -10%.|Treatment difference|7.9|||||TWO_SIDED|95.0|4.1|11.8|||||Treatment difference= Relugolix - Leuprolide acetate|Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of non-inferiority was conducted.||11.8|4.1|
71754636|NCT03085095|143012034|SUPERIORITY|If non-inferiority was demonstrated, superiority could be claimed if the lower bound of the 95% CI for the difference in the cumulative probability of sustained profound castration rate between the 2 treatment groups also excluded 0%. The p value was calculated post hoc.|||||<|0.0001|||||||t-test, 2 sided|Two-sided type I error of 0.05.||Following statistical analysis of the lower bound of the 95% CI ≥ 90% for the relugolix group, secondary statistical analysis of superiority was conducted.||||< 0.0001
71787642|NCT02692716|143073118|SUPERIORITY|This hypothesis was controlled for multiplicity.|Hazard Ratio (HR)|0.79|||=|0.1749|TWO_SIDED|95.0|0.57|1.11||Unadjusted two-sided p-value from test of no difference from 1 (superiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.11|0.57|= 0.1749
71670854|NCT02524847|142859355|OTHER||Overall response rate (%)|55.2|||<|0.001|TWO_SIDED|95.0|35.7|73.6|||t-test, 2 sided|2-sided p-value for testing the null hypothesis H0: Standard therapy has a CR+PR rate = 10% after 4 weeks, using the exact Binomial test.||||73.6|35.7|<.001
71670855|NCT01268527|142859376|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|711.4||||0.0038|TWO_SIDED|95.0|292.5|1130.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, Least Squares Means (LSM), and Confidence Intervals (CI) were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1130.3|292.5|0.0038
71670856|NCT01268527|142859376|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1119.8|||<|0.0001|TWO_SIDED|95.0|858.9|1380.6|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1380.6|858.9|<0.0001
71670857|NCT01268527|142859376|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|780.0||||0.0523|TWO_SIDED|95.0|-8.5|1568.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1568.5|-8.5|0.0523
71670858|NCT01268527|142859376|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|1775.1|||<|0.0001|TWO_SIDED|95.0|1392.3|2158.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||2158.0|1392.3|<0.0001
71670859|NCT01268527|142859376|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|921.4||||0.0002|TWO_SIDED|95.0|515.7|1327.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1327.1|515.7|0.0002
71670860|NCT01268527|142859376|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|937.8||||0.0115|TWO_SIDED|95.0|267.6|1607.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||1607.9|267.6|0.0115
71670861|NCT01268527|142859377|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|101.5||||0.0042|TWO_SIDED|95.0|36.0|167.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||167.0|36.0|0.0042
71787643|NCT02692716|143073119|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.82|||=|0.1827|TWO_SIDED|95.0|0.61|1.1||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.10|0.61|= 0.1827
71845564|NCT00357994|143205619|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.8|STANDARD_ERROR_OF_MEAN|3.1||0.2243|TWO_SIDED|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.4|-9.9|0.2243
71670862|NCT01268527|142859377|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|182.4|||<|0.0001|TWO_SIDED|95.0|140.3|224.4|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||224.4|140.3|<0.0001
71754637|NCT03085095|143012035|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
71754638|NCT03085095|143012036|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
71754639|NCT03085095|143012037|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|Cochran-Mantel-Haenszel|||Alpha-protected statistical analysis.||||< 0.0001
71845565|NCT00357994|143205620|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-4.0|STANDARD_ERROR_OF_MEAN|3.4||0.2407|TWO_SIDED|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||2.8|-10.8|0.2407
71670863|NCT01268527|142859377|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|169.5|||<|0.0001|TWO_SIDED|95.0|127.4|211.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||211.5|127.4|<0.0001
71670864|NCT01268527|142859377|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|246.6|||<|0.0001|TWO_SIDED|95.0|185.0|308.1|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||308.1|185.0|<0.0001
71754640|NCT03085095|143012038|SUPERIORITY||Treatment difference|77.41|||<|0.0001|TWO_SIDED|95.0|73.98|80.83||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.|Treatment difference= Relugolix - Leuprolide acetate|Alpha-protected statistical analysis.||80.83|73.98|< 0.0001
71754641|NCT03085095|143012039|SUPERIORITY||||||<|0.0001||||||Statistically significance was met if p-value \< 0.05.|t-test, 2 sided|Two-sided type I error rate of 0.05.||Alpha-protected statistical analysis.||||< 0.0001
71754642|NCT03085095|143012043|OTHER||Treatment difference|13.0|||||TWO_SIDED|95.0|6.9|19.1|||||Treatment difference= Relugolix - Leuprolide acetate|||19.1|6.9|
71754643|NCT03085095|143012045|OTHER||Treatment difference|-2.9|||||TWO_SIDED|95.0|-7.8|2.0|||||Treatment difference= Relugolix - Leuprolide acetate|||2.0|-7.8|
71754644|NCT00408317|143012061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.74|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CFA% values including sequence, period, and treatment group as fixed effects; participant identification (ID) as random effect.||||<0.0001
71754645|NCT00408317|143012062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.68|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CNA% values including sequence, period, and treatment group as fixed effects, and participant ID as random effect.||||<0.0001
71754646|NCT00834977|143012073|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.08||||||90.0|97.23|105.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.09|97.23|
71754647|NCT00834977|143012074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.38||||||90.0|96.63|102.22|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||102.22|96.63|
71787644|NCT02692716|143073120|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.49|||=|0.0261|TWO_SIDED|95.0|0.27|0.92||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.92|0.27|= 0.0261
71670865|NCT01268527|142859377|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|132.3||||0.0043|TWO_SIDED|95.0|53.9|210.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||210.7|53.9|0.0043
71754648|NCT00834977|143012075|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.48||||||90.0|95.8|101.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.23|95.80|
71754649|NCT00834977|143012076|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.72||||||90.0|86.95|112.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||112.09|86.95|
71754650|NCT00834977|143012077|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.69||||||90.0|90.54|101.14|||||Metabolite presented for informational purposes only.|||101.14|90.54|
71754651|NCT00834977|143012078|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|99.43||||||90.0|96.48|102.46|||||Metabolite presented for informational purposes only.|||102.46|96.48|
71754652|NCT00834977|143012079|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|97.2||||||90.0|92.82|101.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.78|92.82|
71754653|NCT00834977|143012080|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|96.99||||||90.0|92.52|101.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||101.68|92.52|
71754654|NCT00834977|143012081|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.24||||||90.0|96.21|102.35|||||Metabolite presented for informational purposes only.|||102.35|96.21|
71758544|NCT02205736|143019222|SUPERIORITY|||||||0.0028||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 11 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0028
71787645|NCT02692716|143073120|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.18|||=|0.5044|TWO_SIDED|95.0|0.73|1.9||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.90|0.73|= 0.5044
71787646|NCT02692716|143073120|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.74|||=|0.435|TWO_SIDED|95.0|0.35|1.57||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.57|0.35|= 0.4350
71787647|NCT02692716|143073120|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.56|||=|0.3605|TWO_SIDED|95.0|0.6|4.01||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||4.01|0.60|= 0.3605
71787648|NCT02692716|143073120|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.86|||=|0.6227|TWO_SIDED|95.0|0.48|1.55||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.55|0.48|= 0.6227
71787649|NCT02692716|143073121|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0952|TWO_SIDED|95.0|0.56|1.05||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.05|0.56|= 0.0952
71787650|NCT02692716|143073122|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.04||||0.8583|TWO_SIDED|95.0|0.66|1.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.||1.66|0.66|0.8583
71787651|NCT02692716|143073123|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.76||||0.4485|TWO_SIDED|95.0|0.37|1.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||1.56|0.37|0.4485
71787652|NCT02692716|143073124|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.51||||0.0078|TWO_SIDED|95.0|0.31|0.84||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.||0.84|0.31|0.0078
71787653|NCT02692716|143073125|OTHER|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.42|2.3||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.||2.30|1.42|<0.0001
71787654|NCT03562481|143073138|EQUIVALENCE|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.|F statistic|0.8||||0.38|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|Analysis of variance for a 2x2 crossover study implemented using the pkcross routine of Stata 16.1, accounting of sequence and period effects.||||||0.38
71787655|NCT03562481|143073139|EQUIVALENCE|Equivalence was defined as a non-statistically significant difference.|F statistic|1.21||||0.28|TWO_SIDED|||||The threshold for statistical significance p\<0.05|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 and accounting for sequence and period effects.||||0.28
71787656|NCT03562481|143073140|EQUIVALENCE|Equivalence was defined based on statistical significance in the cross-over ANOVA.|F statistic|11.1||||0.003|TWO_SIDED|||||This is adjusted for period and sequence effects and is statistically significant at the p\<0.05 level.|ANOVA|||Analysis of variance for 2x2 crossover study using the pkcross routine of Stata 16.1 adjusting for perio and sequence effects.||||0.003
71787657|NCT03562481|143073141|EQUIVALENCE|Equivalence was determined based on the statistical significance of the Wilcoxon signed-rank test.|Z score|-0.996||||0.33|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sign test|Wilcoxon signed-rank test||||||0.33
71787658|NCT03562481|143073142|EQUIVALENCE|Equivalence was determined based on the statistical significance of the chi square test.|Chi-square test|0.81||||0.37|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Chi-squared|||||||0.37
71670866|NCT01268527|142859377|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|145.0||||0.0036|TWO_SIDED|95.0|64.2|225.8|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM) and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||225.8|64.2|0.0036
71754655|NCT00286468|143012089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.59|-0.19||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level, and \>=80% of subjects meeting per protocol criteria.||-0.19|-0.59|<0.001
71754656|NCT00286468|143012089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.73|-0.33||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size \>=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided \>0.05 significance level and \>=80% of subjects meeting per-protocol criteria.||-0.33|-0.73|<0.001
71754657|NCT00286468|143012090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.13||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.13|-0.33|<0.001
71754658|NCT00286468|143012090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.18|-0.38|<0.001
71754659|NCT00286468|143012091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001|TWO_SIDED|95.0|-0.53|-0.26||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.26|-0.53|<0.001
71754660|NCT00286468|143012091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.61|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.61|<0.001
71754661|NCT00286468|143012092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.25|-0.57|<0.001
71754662|NCT00286468|143012092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.68|-0.36||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.36|-0.68|<0.001
71754663|NCT00286468|143012093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001|TWO_SIDED|95.0|-0.54|-0.19||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.19|-0.54|<0.001
71754664|NCT00286468|143012093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.33|-0.68|<0.001
71787659|NCT03562481|143073143|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|0.2||||0.65|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Stuart-Maxwell test of marginal homogeneity implemented with the symmetry routine in Stata 16.1||||0.65
71892056|NCT00642642|143305603|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||a priori threshold for statistical significance = 0.05|McNemar|paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar's paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks \& 50% correlation between endpoints"||||<0.0001
71670867|NCT01268527|142859378|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|80.7||||0.0013|TWO_SIDED|95.0|34.6|126.7|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||126.7|34.6|0.0013
71670868|NCT01268527|142859378|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|127.9|||<|0.0001|TWO_SIDED|95.0|92.4|163.5|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.5|92.4|<0.0001
71670869|NCT01268527|142859378|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|110.2||||0.0458|TWO_SIDED|95.0|2.4|218.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||218.0|2.4|0.0458
71670870|NCT01268527|142859378|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|207.5|||<|0.0001|TWO_SIDED|95.0|155.2|259.9|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||259.9|155.2|<0.0001
71670871|NCT01268527|142859378|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|125.3||||0.0003|TWO_SIDED|95.0|71.5|179.0|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||179.0|71.5|0.0003
71670872|NCT01268527|142859378|SUPERIORITY||Difference in LSM (vehicle - E6201 gel)|128.6||||0.0029|TWO_SIDED|95.0|93.9|163.3|||ANCOVA|||The following hypotheses were based on the Full Analysis Population: null Hypothesis and alternative hypothesis. P values, LSM, and CI were obtained from ANCOVA model with factors for treatment and baseline psoriatic infiltrate thickness as a continuous covariate.||163.3|93.9|0.0029
71670873|NCT01288079|142859383|SUPERIORITY_OR_OTHER||LS mean|-1.5|STANDARD_ERROR_OF_MEAN|2.95||0.617|TWO_SIDED|95.0|-7.35|4.39|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||4.39|-7.35|0.617
71670874|NCT01288079|142859383|SUPERIORITY_OR_OTHER||LS mean|-3.6|STANDARD_ERROR_OF_MEAN|3.26||0.277|TWO_SIDED|95.0|-10.06|2.91|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.91|-10.06|0.277
71754665|NCT00286468|143012094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.17|-0.54|<0.001
71754666|NCT00286468|143012094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.001|TWO_SIDED|95.0|-0.71|-0.34||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.34|-0.71|<0.001
71754667|NCT00286468|143012095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1||||0.006|TWO_SIDED|95.0|-20.8|-3.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-3.4|-20.8|0.006
71754668|NCT00286468|143012095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|||<|0.001|TWO_SIDED|95.0|-28.0|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-10.6|-28.0|<0.001
71787660|NCT03562481|143073144|EQUIVALENCE|Equivalence was defined based on significance in the symmetry test.|Chi-square test|0.14||||0.71|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry or marginal homogeneity (Stuart-Maxwell) implemented with the symmetry routine in Stata 16.1.||||0.71
71670875|NCT01288079|142859383|SUPERIORITY_OR_OTHER||LS mean|-3.9|STANDARD_ERROR_OF_MEAN|2.95||0.194|TWO_SIDED|95.0|-9.72|2.0|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.||2.00|-9.72|0.194
71670876|NCT03170544|142859393|OTHER||Mean|1.33|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.63|2.04|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|2.04|0.63|
71787661|NCT03562481|143073145|EQUIVALENCE|Equivalence was defined based on statistical significance in the symmetry test.|Chi-square test|1.0||||0.32|TWO_SIDED|||||The threshold for statistical significance p\<0.05|Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.32
71892057|NCT00332202|143305637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.541|TWO_SIDED|95.0|0.689|1.216|||Log Rank|||||1.216|0.689|0.541
71670877|NCT03170544|142859393|OTHER||Mean|2.74|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|2.03|3.44|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).|3.44|2.03|
71670878|NCT00908544|142859417|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|0.2||||0.98|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.98
71670879|NCT00908544|142859417|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-1.7|-1.1|||t-test, 1 sided|||||-1.1|-1.7|<0.01
71670880|NCT00908544|142859417|OTHER|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|0.12||||0.93|TWO_SIDED|95.0|-0.1|0.3|||t-test, 1 sided|||||0.3|-0.1|0.93
71670881|NCT00908544|142859417|OTHER|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|-1.3|||<|0.01|TWO_SIDED|95.0|-1.6|-1.0|||t-test, 1 sided|||||-1.0|-1.6|<0.01
71670882|NCT00908544|142859418|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|0.2||||0.99|TWO_SIDED|95.0|0.0|0.4|||t-test, 1 sided|||||0.4|0.0|0.99
71670883|NCT00908544|142859418|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.5|||t-test, 1 sided|||||-1.5|-2.0|<0.01
71670884|NCT00908544|142859418|OTHER|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|0.2||||0.97|TWO_SIDED|95.0|0.0|0.3|||t-test, 1 sided|||||0.3|-0.0|0.97
71670885|NCT00908544|142859418|OTHER|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|-1.7|||<|0.01|TWO_SIDED|95.0|-2.0|-1.4|||t-test, 1 sided|||||-1.4|-2.0|<0.01
71754669|NCT00286468|143012096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|||<|0.001|TWO_SIDED|95.0|-22.5|-7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-7.2|-22.5|<0.001
71754670|NCT00286468|143012096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||<|0.001|TWO_SIDED|95.0|-27.7|-12.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-12.4|-27.7|<0.001
71754671|NCT00286468|143012097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.01|TWO_SIDED|95.0|-19.3|-2.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.6|-19.3|0.010
71754672|NCT00286468|143012097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.8|-9.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-9.1|-25.8|<0.001
71754673|NCT00286468|143012098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-25.2|-8.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-8.2|-25.2|<0.001
71787662|NCT03562481|143073146|EQUIVALENCE|Equivalence was defined based on the statistical significance of the symmetry test.|Chi-square test|1.29||||0.26|TWO_SIDED||||||Sruart-Maxwell symmetry test|||Test of symmetry (marginal homogeneity, Stuart-Maxwell) implemented using the symmetry routine in Stata 16.1.||||0.26
71787663|NCT02664441|143073147|SUPERIORITY||Mean Difference (Net)|-1.7||||0.4|TWO_SIDED|95.0|-4.1|0.6|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||0.6|-4.1|0.40
71670886|NCT02387840|142859436|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.0002
71754674|NCT00286468|143012098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|||<|0.001|TWO_SIDED|95.0|-23.9|-6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-6.9|-23.9|<0.001
71787664|NCT02664441|143073148|SUPERIORITY||Mean Difference (Net)|-3.1||||0.02|TWO_SIDED|95.0|-5.7|-0.4|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||-0.4|-5.7|0.02
71670887|NCT02387840|142859436|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.0003
71670888|NCT02387840|142859437|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.081
71670889|NCT02387840|142859437|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.081|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.081
71754675|NCT00286468|143012099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1||||0.03|TWO_SIDED|95.0|-19.2|-1.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-1.0|-19.2|0.030
71754676|NCT00286468|143012099|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.012|TWO_SIDED|95.0|-20.8|-2.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.5|-20.8|0.012
71754677|NCT00286468|143012100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.701|TWO_SIDED|95.0|-11.6|7.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.8|-11.6|0.701
71754678|NCT00286468|143012100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.228|TWO_SIDED|95.0|-15.7|3.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.7|-15.7|0.228
71754679|NCT00286468|143012101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0||||0.097|TWO_SIDED|95.0|-19.6|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.6|-19.6|0.097
71754680|NCT00286468|143012101|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.3||||0.014|TWO_SIDED|95.0|-23.9|-2.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-2.7|-23.9|0.014
71754681|NCT00286468|143012102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8||||0.241|TWO_SIDED|95.0|-18.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.6|-18.3|0.241
71754682|NCT00286468|143012102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.5||||0.072|TWO_SIDED|95.0|-22.0|0.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.9|-22.0|0.072
71754683|NCT00286468|143012103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.775||||0.338|TWO_SIDED|95.0|0.46|1.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||1.306|0.460|0.338
71754684|NCT00286468|143012103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.521||||0.016|TWO_SIDED|95.0|0.306|0.887||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.887|0.306|0.016
71754685|NCT00286468|143012104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.374||||0.003|TWO_SIDED|95.0|0.194|0.72||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.720|0.194|0.003
71754686|NCT00286468|143012104|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.372||||0.003|TWO_SIDED|95.0|0.193|0.718||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||0.718|0.193|0.003
71787665|NCT02664441|143073149|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.032|TWO_SIDED|95.0|-37.8|-2.7|||Regression, Linear|Adjusted for baseline values||Analysis for Fat Intake||-2.7|-37.8|.032
71787666|NCT02664441|143073149|SUPERIORITY||Mean Difference (Net)|-430.0||||0.02|TWO_SIDED|95.0|-761.0|-100.0|||Regression, Linear|Adjusted for baseline values||Analysis for Total Calorie Intake||-100|-761|.02
71787667|NCT02664441|143073150|SUPERIORITY||Geometric Mean Ratio|1.42||||0.19|TWO_SIDED|95.0|0.97|2.08|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.08|0.97|0.19
71845566|NCT00357994|143205621|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-13.8|STANDARD_ERROR_OF_MEAN|3.5||0.0002|TWO_SIDED|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-6.8|-20.8|0.0002
71670890|NCT02387840|142859438|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Comparison of T1 values||||0.12
71670891|NCT02387840|142859438|OTHER|This test was a two-sample test using non-parametric data. A predefined margin was not used because no gold standard exists. A p-value of less than 0.05 was considered statistically different||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Comparison of T2 values||||0.14
71670892|NCT03888469|142859453|NON_INFERIORITY|Non-inferiority margin = 0.05|Least Squares Mean Difference|0.0|||||ONE_SIDED|95.0||0.0|||Mixed effects repeated measures model|Mixed effects repeated measures model with terms for lens, period and sequence as fixed effects and subject as a random effect.|Difference = DDT2 - Moist|||0.00||
71670893|NCT03477006|142859457|SUPERIORITY|||||||0.91|||||||Chi-squared|||||||0.91
71670894|NCT03477006|142859458|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
71670895|NCT03477006|142859459|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
71670896|NCT02174627|142859472|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% confidence interval (CI) of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|1.27|1.43|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.43|1.27|<0.001
71670897|NCT02174627|142859473|SUPERIORITY||Relative Risk|9.12|||<|0.001|TWO_SIDED|95.0|7.63|10.89|||Cochran-Mantel-Haenszel|||Comparison of the percentage of responders for roxadustat versus placebo was analysed using a Cochran-Mantel-Haenszel test adjusting for baseline Hb, baseline eGFR, geographic region and CV history.||10.89|7.63|<0.001
71754687|NCT00286468|143012105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.923|TWO_SIDED|95.0|-6.1|6.7||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.7|-6.1|0.923
71754688|NCT00286468|143012105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.259|TWO_SIDED|95.0|-2.7|10.1||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||10.1|-2.7|0.259
71754689|NCT00286468|143012106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.916|TWO_SIDED|95.0|-6.6|5.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.9|-6.6|0.916
71754690|NCT00286468|143012106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.305|TWO_SIDED|95.0|-3.0|9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||9.5|-3.0|0.305
71754691|NCT00286468|143012107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.953|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.953
71892058|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 2||||0.606
71892059|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 4||||0.971
71892060|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.580
71892061|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 12||||0.265
71892062|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 18||||0.460
71670898|NCT02174627|142859474|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.91|1.35|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.||1.35|0.91|<0.001
71670899|NCT02174627|142859475|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.47|0.52|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.52|0.47|<0.001
71670900|NCT02174627|142859476|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.013|<|0.001|TWO_SIDED|95.0|0.4|0.45|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||0.45|0.40|<0.001
71670901|NCT02174627|142859477|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.033|<|0.001|TWO_SIDED|95.0|-0.42|-0.29|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.||-0.29|-0.42|<0.001
71670902|NCT02174627|142859478|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.26|||<|0.001|TWO_SIDED|95.0|0.23|0.31|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.31|0.23|<0.001
71754692|NCT00286468|143012107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.957|TWO_SIDED|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||5.8|-6.1|0.957
71754693|NCT00286468|143012108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.908|TWO_SIDED|95.0|-5.9|6.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.6|-5.9|0.908
71787668|NCT02664441|143073151|SUPERIORITY||Geometric Mean Ratio|1.0||||0.82|TWO_SIDED|95.0|0.91|1.11|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for HDL Cholesterol||1.11|0.91|0.82
71787669|NCT02664441|143073151|SUPERIORITY||Geometric Mean Ratio|1.0||||0.92|TWO_SIDED|95.0|0.83|1.19|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|Analysis for Triglycerides||1.19|0.83|0.92
71787670|NCT02664441|143073152|SUPERIORITY||Geometric Mean Ratio|0.62||||0.03|TWO_SIDED|95.0|0.41|0.92|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||0.92|0.41|0.03
71837154|NCT03683719|143180907|OTHER|Treatment groups were compared using a 2-sided log-rank test stratified by region and baseline IGA-CHE score. An event was defined as the first time achieving IGA-CHE TS.|||||<|0.01||||||The statistical test was not controlled for multiplicity.|Log Rank|||Time to IGA-CHE TS was defined as the time from the date of the first IMP application to first assessment of IGA-CHE TS. Subjects without baseline observation were censored at the date of the first IMP application. Subjects with baseline observation not achieving IGA-CHE TS during the treatment period were censored at the date of the last visit with a valid post-baseline assessment on or prior to the date of discontinuation of IMP or initiation of rescue medication, whichever occurred first.||||<0.01
71754694|NCT00286468|143012108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.826|TWO_SIDED|95.0|-5.6|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||7.0|-5.6|0.826
71754695|NCT00286468|143012109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.894|TWO_SIDED|95.0|-5.9|6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.8|-5.9|0.894
71754696|NCT00286468|143012109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.432|TWO_SIDED|95.0|-3.8|8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||8.9|-3.8|0.432
71754697|NCT00286468|143012110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.548|TWO_SIDED|95.0|-8.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.3|-8.1|0.548
71754698|NCT00286468|143012110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.986|TWO_SIDED|95.0|-6.3|6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.2|-6.3|0.986
71754699|NCT00286468|143012111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26||||0.415|TWO_SIDED|95.0|-1.78|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.30|-1.78|0.415
71837155|NCT03135548|143180951|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% confidence intervals (CI) are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
71754700|NCT00286468|143012111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51||||0.332|TWO_SIDED|95.0|-1.54|4.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.55|-1.54|0.332
71787671|NCT02664441|143073153|SUPERIORITY||Geometric Mean Ratio|1.39||||0.32|TWO_SIDED|95.0|0.9|2.14|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) as covariates|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals|||2.14|0.90|0.32
71787672|NCT02664441|143073154|SUPERIORITY||Geometric Mean Ratio|0.95||||0.69|TWO_SIDED|95.0|0.81|1.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.|Data were log-transformed prior to analysis. Results were back-transformed through exponentiation and presented as geometric mean ratios with 95% confidence intervals.|||1.10|0.81|0.69
71754701|NCT00286468|143012112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.89|TWO_SIDED|95.0|-2.47|2.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||2.85|-2.47|0.890
71754702|NCT00286468|143012112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.38|TWO_SIDED|95.0|-1.48|3.86||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.86|-1.48|0.380
71754703|NCT00286468|143012113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35||||0.448|TWO_SIDED|95.0|-2.14|4.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.85|-2.14|0.448
71754704|NCT00286468|143012113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.568|TWO_SIDED|95.0|-2.48|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.52|-2.48|0.568
71754705|NCT00286468|143012114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95||||0.077|TWO_SIDED|95.0|-0.32|6.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||6.22|-0.32|0.077
71787673|NCT02664441|143073155|SUPERIORITY||Mean Difference (Net)|-166.4||||0.004|TWO_SIDED|95.0|-269.7|-63.1|||Regression, Linear|Adjusted for baseline values||||-63.1|-269.7|0.004
71892063|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.441|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.441
71754706|NCT00286468|143012114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.303|TWO_SIDED|95.0|-1.55|4.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.99|-1.55|0.303
71754707|NCT00286468|143012115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.461|TWO_SIDED|95.0|-2.08|4.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.57|-2.08|0.461
71754708|NCT00286468|143012115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99||||0.559|TWO_SIDED|95.0|-2.34|4.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.32|-2.34|0.559
71754709|NCT00286468|143012116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.43|TWO_SIDED|95.0|-1.54|3.62||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||3.62|-1.54|0.430
71754710|NCT00286468|143012116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.124|TWO_SIDED|95.0|-0.56|4.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||4.61|-0.56|0.124
71754711|NCT00286468|143012117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056||||0.011|TWO_SIDED|95.0|-0.099|-0.013||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.013|-0.099|0.011
71754712|NCT00286468|143012117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035||||0.116|TWO_SIDED|95.0|-0.078|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.078|0.116
71787674|NCT02664441|143073156|SUPERIORITY||Mean Difference (Net)|-145.0||||0.58|TWO_SIDED|95.0|-653.5|363.4|||Regression, Linear|Adjusted for baseline||||363.4|-653.5|0.58
71787675|NCT02664441|143073157|SUPERIORITY||Mean Difference (Net)|-8.5||||0.088|TWO_SIDED|95.0|-19.1|2.1|||Mixed Models Analysis|Randomization stratification variables (site, sex and age group) were used as covariates.||||2.1|-19.1|0.088
71787676|NCT03654651|143073165|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||Mixed Models Analysis|||||1.6|-2.7|
71787677|NCT03654651|143073165|OTHER|change from baseline|Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|||||0.9|-2.7|
71892064|NCT00332202|143305643|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 36||||0.357
71787678|NCT03654651|143073165|OTHER|Change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4|||Mixed Models Analysis|||||1.4|-2.2|
71787679|NCT03654651|143073166|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-4.8|3.4|||Mixed Models Analysis|||||3.4|-4.8|
71892065|NCT00332202|143305644|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 6||||0.267
71754713|NCT00286468|143012118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044||||0.024|TWO_SIDED|95.0|-0.081|-0.006||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.006|-0.081|0.024
71754714|NCT00286468|143012118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.037||||0.059|TWO_SIDED|95.0|-0.074|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.074|0.059
71754715|NCT00286468|143012119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028||||0.159|TWO_SIDED|95.0|-0.067|0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.011|-0.067|0.159
71754716|NCT00286468|143012119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038||||0.055|TWO_SIDED|95.0|-0.077|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.001|-0.077|0.055
71754717|NCT00286468|143012120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039||||0.062|TWO_SIDED|95.0|-0.08|0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.002|-0.080|0.062
71754718|NCT00286468|143012120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.043||||0.041|TWO_SIDED|95.0|-0.084|-0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||-0.002|-0.084|0.041
71754719|NCT00286468|143012121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.148|TWO_SIDED|95.0|-0.069|0.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.010|-0.069|0.148
71670903|NCT02174627|142859479|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.3|0.44|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.||0.44|0.30|<0.001
71670904|NCT02174627|142859480|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.283||0.12|TWO_SIDED|95.0|-0.11|0.99|||Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||0.99|-0.11|0.120
71670905|NCT02174627|142859481|OTHER||Rate of Change Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.254||0.046|TWO_SIDED|95.0|-1.0|-0.01||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Random Effects Analysis|||Difference between groups (roxadustat minus placebo) in rate of change in eGFR; random effects analysis.||-0.01|-1.00|0.046
71670906|NCT02174627|142859482|SUPERIORITY|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.269||0.051|TWO_SIDED|95.0|0.0|1.05||Nominal p-value (as prior sequential outcome measure p-value did not meet \< 0.05.|Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.||1.05|0.00|0.051
71787680|NCT03654651|143073166|OTHER|change from baseline|Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
71787681|NCT03654651|143073166|OTHER|change from baseline|Mean Difference (Final Values)|-3.8|||||TWO_SIDED|95.0|-5.1|5.4|||Mixed Models Analysis|||||5.4|-5.1|
71787682|NCT03654651|143073167|SUPERIORITY||Mean Difference (Final Values)|0.45|||||TWO_SIDED|95.0|-1.2|2.1|||Mixed Models Analysis|||||2.1|-1.2|
71892066|NCT00332202|143305644|SUPERIORITY_OR_OTHER|||||||0.807|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 24||||0.807
71787683|NCT03654651|143073167|OTHER|change from baseline|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-1.5|1.0|||Mixed Models Analysis|||||1.0|-1.5|
71670907|NCT00071110|142859516|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistic (t): -1.00|t-test, 2 sided|||||||0.32
71670908|NCT00071110|142859517|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||Statistic (t): 1.56|t-test, 2 sided|||||||0.09
71670909|NCT00071110|142859518|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||Statistic (t): 1.40|t-test, 2 sided|||||||0.17
71670910|NCT03578367|142859550|OTHER|No test performed|Risk Difference (RD)|19.5|||||TWO_SIDED|90.0|5.0|33.1||||||||33.1|5.0|
71670911|NCT03578367|142859550|OTHER|No test performed|Risk Difference (RD)|28.57|||||TWO_SIDED|90.0|12.4|44.8||||||||44.8|12.4|
71787684|NCT03654651|143073167|OTHER|change from baseline|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5|||Mixed Models Analysis|||||0.5|-2.1|
71787685|NCT03654651|143073168|SUPERIORITY||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-3.1|4.6|||Mixed Models Analysis|||peripheral systolic BP||4.6|-3.1|
71787686|NCT03654651|143073168|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||peripheral diastolic BP||2.9|-2.1|
71787687|NCT03654651|143073168|OTHER|change from baseline|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||peripheral systolic BP change from baseline||3.3|-2.5|
71892067|NCT00332202|143305644|SUPERIORITY_OR_OTHER|||||||0.864|TWO_SIDED||||||Mixed Models Analysis|||Analysis for Month 33||||0.864
71787688|NCT03654651|143073168|OTHER|change from baseline|Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-3.1|2.6|||Mixed Models Analysis|||peripheral systolic BP change from baseline||2.6|-3.1|
71787689|NCT03654651|143073168|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2.5|-1.5|
71787690|NCT03654651|143073168|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Mixed Models Analysis|||peripheral diastolic BP change from baseline||2|-2|
71787691|NCT03654651|143073169|SUPERIORITY||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.4|4.4|||Mixed Models Analysis|||central systolic BP||4.4|-2.4|
71787692|NCT03654651|143073169|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-1.7|3.3|||Mixed Models Analysis|||central diastolic BP||3.3|-1.7|
71787693|NCT03654651|143073169|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||Mixed Models Analysis|||central systolic BP change from baseline||3.1|-1.9|
71787694|NCT03654651|143073169|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.9|2.1|||Mixed Models Analysis|||central systolic BP change from baseline||2.1|-2.9|
71787695|NCT03654651|143073169|OTHER|change from baseline|Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.6|||Mixed Models Analysis|||central diastolic BP change from baseline||2.6|-1.5|
71787696|NCT03654651|143073169|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.4|1.6|||Mixed Models Analysis|||central diastolic BP change from baseline||1.6|-2.4|
71787697|NCT03654651|143073170|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|0.5|||Mixed Models Analysis|||||0.5|-0.1|
71787698|NCT03654651|143073170|OTHER|change from baseline|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||||0.6|0.1|
71787699|NCT03654651|143073170|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|
71670912|NCT03578367|142859551|OTHER|No test performed|Risk Difference (RD)|14.29|||||TWO_SIDED|90.0|-1.7|30.3||||||||30.3|-1.7|
71787700|NCT03654651|143073171|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-5.9|3.3|||Mixed Models Analysis|||||3.3|-5.9|
71787701|NCT03654651|143073171|OTHER|change from baseline|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-3.7|2.9|||Mixed Models Analysis|||||2.9|-3.7|
71787702|NCT03654651|143073171|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-4.0|4.3|||Mixed Models Analysis|||||4.3|-4.0|
71787703|NCT03654651|143073172|SUPERIORITY||Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-1.4|9.8|||Mixed Models Analysis|||||9.8|-1.4|
71787704|NCT03654651|143073172|OTHER|change from baseline|Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-2.1|6.9|||Mixed Models Analysis|||||6.9|-2.1|
71787705|NCT03654651|143073172|OTHER|change from baseline|Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-6.8|2.2|||Mixed Models Analysis|||||2.2|-6.8|
71787706|NCT03654651|143073173|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.3|2.3|||Mixed Models Analysis|||||2.3|-2.3|
71787707|NCT03654651|143073173|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|
71787708|NCT03654651|143073173|OTHER|change from baseline|Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||||2.3|-1.6|
71787709|NCT03654651|143073174|SUPERIORITY||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-3.8|8.2|||Mixed Models Analysis|||||8.2|-3.8|
71787710|NCT03654651|143073174|OTHER|change from baseline|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-4.9|5.1|||Mixed Models Analysis|||||5.1|-4.9|
71787711|NCT03654651|143073174|OTHER|change from baseline|Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-7.8|2.3|||Mixed Models Analysis|||||2.3|-7.8|
71787712|NCT03654651|143073175|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-18.3|2.8|||Mixed Models Analysis|||||2.8|-18.3|
71787713|NCT03654651|143073175|OTHER|change from baseline|Mean Difference (Final Values)|-17.0|||||TWO_SIDED|95.0|-29.1|-4.8|||Mixed Models Analysis|||||-4.8|-29.1|
71787714|NCT03654651|143073175|OTHER|change from baseline|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-17.1|5.7|||Mixed Models Analysis|||||5.7|-17.1|
71787715|NCT03654651|143073176|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|
71670913|NCT03578367|142859551|OTHER|No test performed|Risk Difference (RD)|23.81|||||TWO_SIDED|90.0|5.9|41.7||||||||41.7|5.9|
71787716|NCT03654651|143073176|OTHER|change from baseline|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.1|1.5|||Mixed Models Analysis|||||1.5|-0.1|
71787717|NCT03654651|143073176|OTHER|change from baseline|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||||0.5|-0.5|
71787718|NCT01702454|143073178|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|8.97|||||TWO_SIDED|95.0|6.21|12.96|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||12.96|6.21|
71837156|NCT03135548|143180951|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||TWO_SIDED|95.0|-0.19|0.338|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.338|-0.190|
71837157|NCT03135548|143180953|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.095|||||TWO_SIDED|95.0|-0.289|0.086|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.086|-0.289|
71845567|NCT00357994|143205622|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-3.3|STANDARD_ERROR_OF_MEAN|5.1||0.5213|TWO_SIDED|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||6.9|-13.6|0.5213
71787719|NCT01702454|143073178|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|2.7|||||TWO_SIDED|95.0|1.81|4.02|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval|The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||4.02|1.81|
71754720|NCT00286468|143012121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031||||0.135|TWO_SIDED|95.0|-0.071|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.009|-0.071|0.135
71754721|NCT00286468|143012122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
71754722|NCT00286468|143012122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026||||0.177|TWO_SIDED|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.012|-0.065|0.177
71754723|NCT00286468|143012123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162||||0.324|TWO_SIDED|95.0|-0.161|0.486||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.486|-0.161|0.324
71754724|NCT00286468|143012123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.284|TWO_SIDED|95.0|-0.147|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.500|-0.147|0.284
71754725|NCT00286468|143012124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268||||0.053|TWO_SIDED|95.0|-0.004|0.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.540|-0.004|0.053
71754726|NCT00286468|143012124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349||||0.012|TWO_SIDED|95.0|0.077|0.621||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.621|0.077|0.012
71754727|NCT00286468|143012125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.196|TWO_SIDED|95.0|-0.094|0.458||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.458|-0.094|0.196
71754728|NCT00286468|143012125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226||||0.11|TWO_SIDED|95.0|-0.051|0.502||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.502|-0.051|0.110
71754729|NCT00286468|143012126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228||||0.121|TWO_SIDED|95.0|-0.06|0.517||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.517|-0.060|0.121
71754730|NCT00286468|143012126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159||||0.28|TWO_SIDED|95.0|-0.13|0.448||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.448|-0.130|0.280
71787720|NCT01702454|143073178|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|3.94|||||TWO_SIDED|95.0|2.89|5.37|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||5.37|2.89|
71787721|NCT01702454|143073178|NON_INFERIORITY_OR_EQUIVALENCE|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|6.71|||||TWO_SIDED|95.0|5.21|8.63|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.||8.63|5.21|
71670914|NCT02729025|142859569|SUPERIORITY||LS Mean Treatment Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.24||0.18|TWO_SIDED|95.0|-7.4|1.39|||Multivariate regression model||Treatment difference used placebo as the reference|A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp\[a\] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp\[a\]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.||1.39|-7.40|0.18
71754731|NCT00286468|143012127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015||||0.924|TWO_SIDED|95.0|-0.29|0.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.320|-0.290|0.924
71754732|NCT00286468|143012127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138||||0.376|TWO_SIDED|95.0|-0.168|0.444||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.444|-0.168|0.376
71754733|NCT00286468|143012128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075||||0.642|TWO_SIDED|95.0|-0.242|0.393||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.393|-0.242|0.642
71754734|NCT00286468|143012128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063||||0.698|TWO_SIDED|95.0|-0.255|0.381||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||0.381|-0.255|0.698
71754735|NCT00286468|143012129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.596|TWO_SIDED|95.0|0.503|3.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.306|0.503|0.596
71754736|NCT00286468|143012129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.148|TWO_SIDED|95.0|0.787|4.885||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.885|0.787|0.148
71754737|NCT00286468|143012130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.925||||0.046|TWO_SIDED|95.0|1.011|3.666||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.666|1.011|0.046
71754738|NCT00286468|143012130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.505||||0.005|TWO_SIDED|95.0|1.313|4.78||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||4.780|1.313|0.005
71754739|NCT00286468|143012131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.025|TWO_SIDED|95.0|1.086|3.519||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.519|1.086|0.025
71754740|NCT00286468|143012131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.707|||<|0.001|TWO_SIDED|95.0|2.012|6.831||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.831|2.012|<0.001
71754741|NCT00286468|143012132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.994|||<|0.001|TWO_SIDED|95.0|1.72|5.213||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.213|1.720|<0.001
71787722|NCT01702454|143073180|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|44.74|||||TWO_SIDED|95.0|35.87|52.84||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||52.84|35.87|
71787723|NCT01702454|143073180|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|45.31|||||TWO_SIDED|95.0|36.58|53.3||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||53.3|36.58|
71670915|NCT02729025|142859570|SUPERIORITY||LS Mean Treatment Difference|-13.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED|95.0|-19.29|-8.49|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-8.49|-19.29|<0.0001
71787724|NCT01702454|143073180|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|37.86||||||95.0|28.83|46.26||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||46.26|28.83|
71892068|NCT00332202|143305645|SUPERIORITY||Hazard Ratio (HR)|0.768||||0.4|TWO_SIDED|95.0|0.415|1.42|||Regression, Cox|||||1.420|0.415|0.400
71754742|NCT00286468|143012132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.401|||<|0.001|TWO_SIDED|95.0|1.95|5.933||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.933|1.950|<0.001
71754743|NCT00286468|143012133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.776||||0.115|TWO_SIDED|95.0|0.87|3.627||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||3.627|0.870|0.115
71754744|NCT00286468|143012133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.416|||<|0.001|TWO_SIDED|95.0|1.703|6.851||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||6.851|1.703|<0.001
71754745|NCT00286468|143012134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.991||||0.986|TWO_SIDED|95.0|0.365|2.689||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||2.689|0.365|0.986
71754746|NCT00286468|143012134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.131|TWO_SIDED|95.0|0.808|5.203||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR \<1.0 indicates lower incidence compared to placebo.|||5.203|0.808|0.131
71754747|NCT00286468|143012135|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.626
71787725|NCT01702454|143073180|NON_INFERIORITY_OR_EQUIVALENCE|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in percentages|56.0||||||95.0|48.32|63.04||||||"To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.04|48.32|
71787726|NCT01702454|143073182|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|62.43|||||TWO_SIDED|95.0|55.27|68.89||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains||68.89|55.27|
71787727|NCT01702454|143073182|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|47.4|||||TWO_SIDED|95.0|39.08|55.06||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||55.06|39.08|
71837158|NCT03135548|143180953|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.115|||||TWO_SIDED|95.0|-0.116|0.348|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.|Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.|||0.348|-0.116|
71754748|NCT00286468|143012135|SUPERIORITY_OR_OTHER|||||||0.178||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.||||||0.178
71754749|NCT00286468|143012136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.001|TWO_SIDED|95.0|0.32|1.16||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.16|0.32|<0.001
71787728|NCT01702454|143073182|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in SPR|56.68|||||TWO_SIDED|95.0|49.44|63.43||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.||63.43|49.44|
71837159|NCT03135548|143180954|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|7.24|||||TWO_SIDED|95.0|-20.01|34.48|||Student's t-distribution|CIs were based on Student's t-distribution.||||34.48|-20.01|
71754750|NCT00286468|143012136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.006|TWO_SIDED|95.0|0.17|1.02||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.02|0.17|0.006
71754751|NCT00286468|143012137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.006|TWO_SIDED|95.0|0.2|1.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.18|0.20|0.006
71787729|NCT01702454|143073182|NON_INFERIORITY_OR_EQUIVALENCE|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|56.72|||||TWO_SIDED|95.0|49.41|63.49||||||"To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"||63.49|49.41|
71837160|NCT03135548|143180954|OTHER|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-28.35|16.7|||Student's t-distribution|CIs were based on Student's t-distribution.||||16.70|-28.35|
71837161|NCT03135548|143180955|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.143|||||TWO_SIDED|95.0|-0.346|0.049|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.049|-0.346|
71670916|NCT02729025|142859571|SUPERIORITY||LS Mean Treatment Difference|-60.66|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-65.81|-55.51|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-55.51|-65.81|<0.0001
71670917|NCT02729025|142859572|SUPERIORITY||LS Mean Treatment Difference|-51.29|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-55.85|-47.33|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference|||-47.33|-55.85|<0.0001
71754752|NCT00286468|143012137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.04|TWO_SIDED|95.0|0.02|1.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.01|0.02|0.040
71754753|NCT00286468|143012138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.47|1.73||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.73|0.47|<0.001
71754754|NCT00286468|143012138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.005|TWO_SIDED|95.0|0.28|1.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.55|0.28|0.005
71754755|NCT00286468|143012139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.018|TWO_SIDED|95.0|0.14|1.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.46|0.14|0.018
71754756|NCT00286468|143012139|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.01|TWO_SIDED|95.0|0.21|1.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|||1.54|0.21|0.010
71754757|NCT03324607|143012140|OTHER|||||||0.006|||||||Paired t-test|||||||0.006
71754758|NCT00129402|143012173|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71754759|NCT00129402|143012174|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71754760|NCT00129402|143012175|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71754761|NCT00129402|143012176|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48||95.0|||||non-parametric model|||||||.48
71754762|NCT00129402|143012177|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||ANOVA|||||||<0.01
71670918|NCT01267019|142859573|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).||||< .05
71787730|NCT03247530|143073219|SUPERIORITY||Least Square Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.61||0.0004|TWO_SIDED|95.0|-8.9|-2.6|||Mixed Models for Repeated Measures|||||-2.6|-8.9|0.0004
71787731|NCT03247530|143073219|SUPERIORITY||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-10.0|-3.8|||Mixed Models for Repeated Measures|||||-3.8|-10.0|<0.0001
71754763|NCT00129402|143012178|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95||95.0|||||ANOVA|||||||.95
71754764|NCT00573508|143012212|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.4|||<|0.0001||95.0|6.6|12.2|||ANCOVA|||Statistical Analysis applies to 'Change at End of Treatment'.||12.2|6.6|<0.0001
71754765|NCT00573508|143012213|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.||||<.0001
71754766|NCT00573508|143012214|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-Value represents change from Baseline to Week 12.|ANCOVA|||Statistical Analysis applies to 'Change at Week 12'.||||<.0001
71754767|NCT00573508|143012215|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71754768|NCT00573508|143012223|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-16.8|||<|0.0001||95.0|-22.1|-11.6|||ANCOVA|||Statistical Analysis applies to 'Change at EOT'.||-11.6|-22.1|<.0001
71754769|NCT03253796|143012226|SUPERIORITY||Difference in percentage|50.2|||<|0.001|TWO_SIDED|95.0|34.1|63.6|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||63.6|34.1|<0.001
71754770|NCT03253796|143012226|SUPERIORITY||Difference in percentage|34.4|||<|0.001|TWO_SIDED|95.0|17.0|49.7|||Meittinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||49.7|17.0|<0.001
71787732|NCT03247530|143073220|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.2|-0.7|0.0020
71837162|NCT03135548|143180955|OTHER|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.015|||||TWO_SIDED|95.0|-0.213|0.252|||Wilson/Newcombe|95% CIs are calculated using the method of Wilson/Newcombe.||||0.252|-0.213|
71837163|NCT03924986|143180956|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.73|0.38|
71837164|NCT03924986|143180957|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.11|3.07|||||||Arm B was the reference group, and the odds ratio between arms was calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by gender and liver metastases status.|3.07|1.11|
71754771|NCT03253796|143012229|SUPERIORITY||Difference in percentage|9.5|||||TWO_SIDED|95.0|3.3|19.4|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||19.4|3.3|
71754772|NCT03253796|143012229|SUPERIORITY||Difference in percentage|3.2|||||TWO_SIDED|95.0|-2.8|10.9|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||10.9|-2.8|
71754773|NCT03253796|143012231|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
71754774|NCT03253796|143012231|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|-5.9|5.8|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||5.8|-5.9|
71754775|NCT03253796|143012233|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.0|0.2|
71754776|NCT03253796|143012233|SUPERIORITY||Difference in percentage|14.7|||||TWO_SIDED|95.0|0.2|29.1|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||29.1|0.2|
71670919|NCT01267019|142859574|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71754777|NCT03253796|143012235|SUPERIORITY||Difference in percentage|24.9|||||TWO_SIDED|95.0|8.5|40.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||40.3|8.5|
71754778|NCT03253796|143012235|SUPERIORITY||Difference in percentage|5.9|||||TWO_SIDED|95.0|-9.9|21.3|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||21.3|-9.9|
71754779|NCT03253796|143012237|SUPERIORITY||Difference in percentage|24.4|||||TWO_SIDED|95.0|9.1|39.0|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||39.0|9.1|
71787733|NCT03247530|143073220|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.3|-0.8|<0.0001
71787734|NCT03247530|143073221|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.16||0.0003|TWO_SIDED|95.0|-6.5|-1.9|||ANCOVA|||||-1.9|-6.5|0.0003
71892069|NCT00332202|143305645|SUPERIORITY||Hazard Ratio (HR)|1.309||||0.539|TWO_SIDED|95.0|0.557|3.08|||Regression, Cox|||||3.080|0.557|0.539
71670920|NCT01267019|142859575|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<.05
71670921|NCT03504397|142859665|SUPERIORITY||Hazard Ratio (HR)|0.734||||0.0024|TWO_SIDED|95.0|0.591|0.91||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.910|0.591|0.0024
71754780|NCT03253796|143012237|SUPERIORITY||Difference in percentage|22.8|||||TWO_SIDED|95.0|7.3|37.7|||||Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor|||37.7|7.3|
71754781|NCT03253796|143012241|SUPERIORITY||Difference in percentage|32.9|||<|0.001|TWO_SIDED|95.0|19.2|44.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||44.5|19.2|<0.001
71754782|NCT03253796|143012242|SUPERIORITY||Difference in percentage|15.9||||0.037|TWO_SIDED|95.0|0.9|30.5|||Miettinen and Nurminen|Derived based on the stratified Miettinen and Nurminen method with CRP level (\>6 mg/L or ≤ 6 mg/L) as a stratification factor||||30.5|0.9|0.037
71754783|NCT00528112|143012243|SUPERIORITY_OR_OTHER||failure rate|0.009|||||TWO_SIDED|95.0|0.005|0.017||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.017|0.005|
71754784|NCT00528112|143012243|SUPERIORITY_OR_OTHER||failure rate|0.01||||||95.0|0.005|0.018||||||Cumulative failure rate (Kaplan-Meier) at 3 years||0.018|0.005|
71754785|NCT00528112|143012265|SUPERIORITY_OR_OTHER||failure rate|0.01445|||||TWO_SIDED|95.0|0.00823|0.02531||||||Cumulative failure rate (Kaplan-Meier) at 5 years||0.02531|0.00823|
71754786|NCT02718898|143012270|SUPERIORITY||Odds Ratio (OR)|33.8|||<|0.001|TWO_SIDED|95.0|12.39|92.23|||Regression, Logistic|||||92.23|12.39|<0.001
71754787|NCT02718898|143012271|SUPERIORITY||Odds Ratio (OR)|102.55|||<|0.001|TWO_SIDED|95.0|22.79|461.43|||Regression, Logistic|||||461.43|22.79|<0.001
71754788|NCT02718898|143012272|SUPERIORITY||Odds Ratio (OR)|16.27|||<|0.001|TWO_SIDED|95.0|5.71|46.4|||Regression, Logistic|||||46.40|5.71|<0.001
71754789|NCT02718898|143012273|SUPERIORITY||Odds Ratio (OR)|13.57|||<|0.001|TWO_SIDED|95.0|4.57|40.29|||Regression, Logistic|||||40.29|4.57|<0.001
71754790|NCT02718898|143012274|SUPERIORITY||Odds Ratio (OR)|9.84|||<|0.001|TWO_SIDED|95.0|3.08|31.4|||Regression, Logistic|||||31.40|3.08|<0.001
71754791|NCT02718898|143012275|SUPERIORITY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|-10.1|-6.7|||Mixed Models Analysis|||||-6.7|-10.1|<0.001
71754792|NCT02718898|143012276|SUPERIORITY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-24.3|-15.8|||Mixed Models Analysis|||||-15.8|-24.3|<0.001
71754793|NCT02718898|143012277|SUPERIORITY||Odds Ratio (OR)|13.95|||<|0.001|TWO_SIDED|95.0|6.12|31.8|||Regression, Logistic|||||31.80|6.12|<0.001
71754794|NCT02718898|143012278|SUPERIORITY||Mean Difference (Final Values)|4.506|STANDARD_ERROR_OF_MEAN|1.1339|<|0.001|TWO_SIDED|95.0|2.264|6.748|||ANCOVA|||||6.748|2.264|<0.001
71754795|NCT02718898|143012279|SUPERIORITY||Mean Difference (Final Values)|1.797|STANDARD_ERROR_OF_MEAN|1.0367||0.085|TWO_SIDED|95.0|-0.253|3.847|||ANCOVA|||||3.847|-0.253|0.085
71754796|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|3.015|<|0.001|TWO_SIDED|95.0|-34.72|-22.78|||Mixed Models Analysis|||Total Score||-22.78|-34.72|<0.001
71754797|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.399|<|0.001|TWO_SIDED|95.0|-4.6|-3.02|||Mixed Models Analysis|||Itch||-3.02|-4.60|<0.001
71787735|NCT03247530|143073221|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.15||0.0002|TWO_SIDED|95.0|-6.6|-2.1|||ANCOVA|||||-2.1|-6.6|0.0002
71787736|NCT03247530|143073222|SUPERIORITY||Least Square Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.047||0.0019|TWO_SIDED|95.0|-0.24|-0.05|||ANCOVA|||||-0.05|-0.24|0.0019
71670922|NCT03504397|142859666|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.0075|TWO_SIDED|95.0|0.644|0.954||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||0.954|0.644|0.0075
71670923|NCT03504397|142859667|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.028|TWO_SIDED|95.0|0.994|1.687||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.687|0.994|0.0280
71754798|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|0.405|<|0.001|TWO_SIDED|95.0|-4.3|-2.7|||Mixed Models Analysis|||Pain||-2.70|-4.30|<0.001
71754799|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.85|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.66|-3.04|||Mixed Models Analysis|||Discomfort||-3.04|-4.66|<0.001
71754800|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-4.04|-2.42|||Mixed Models Analysis|||Stinging||-2.42|-4.04|<0.001
71754801|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-3.99|-2.41|||Mixed Models Analysis|||Burning||-2.41|-3.99|<0.001
71754802|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|-4.59|-3.03|||Mixed Models Analysis|||Redness||-3.03|-4.59|<0.001
71754803|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.78|STANDARD_ERROR_OF_MEAN|0.377|<|0.001|TWO_SIDED|95.0|-4.53|-3.03|||Mixed Models Analysis|||Scaling||-3.03|-4.53|<0.001
71754804|NCT02718898|143012280|SUPERIORITY||Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|0.385|<|0.001|TWO_SIDED|95.0|-4.31|-2.79|||Mixed Models Analysis|||Cracking||-2.79|-4.31|<0.001
71670924|NCT03504397|142859668|SUPERIORITY||Hazard Ratio (HR)|0.713||||0.0508|TWO_SIDED|95.0|0.475|1.071||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|Log Rank|||||1.071|0.475|0.0508
71754805|NCT03337308|143012288|SUPERIORITY||Difference of Least Squares (LS) means|-38.0|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-46.5|-29.6|||ANCOVA||Standard Error of the Difference of Least Squares (LS) Means|||-29.6|-46.5|<0.001
71754806|NCT03337308|143012288|SUPERIORITY||Difference of LS means|-19.0|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-26.1|-11.9|||ANCOVA||Standard Error of the Difference of LS Means|||-11.9|-26.1|<0.001
71754807|NCT03337308|143012288|SUPERIORITY||Difference of LS means|-13.1|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-19.7|-6.5|||ANCOVA||Standard Error of the Difference of LS Means|||-6.5|-19.7|<0.001
71754808|NCT03337308|143012289|SUPERIORITY||Location shift|-46.1|STANDARD_ERROR_OF_MEAN|12.22|<|0.001|TWO_SIDED|99.0|-78.75|-15.78||using alpha = 0.01|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-15.78|-78.75|<0.001
71754809|NCT03337308|143012289|SUPERIORITY||Median Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|8.14||0.002|TWO_SIDED|98.0|-45.0|-7.15||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||-7.15|-45.00|0.002
71754810|NCT03337308|143012289|SUPERIORITY||Median Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|8.08||0.734|TWO_SIDED|98.0|-21.35|16.25||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference|||16.25|-21.35|0.734
71754811|NCT03337308|143012290|SUPERIORITY|using alpha = 0.01|Difference in LS mean|-33.7|STANDARD_ERROR_OF_MEAN|3.97|<|0.001|TWO_SIDED|99.0|-43.9|-23.4|||ANCOVA||Standard Error of the Difference of LS Means|||-23.4|-43.9|<0.001
71754812|NCT03337308|143012290|SUPERIORITY||Difference in LS means|-17.8|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|98.0|-25.1|-10.5||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-10.5|-25.1|<0.001
71754813|NCT03337308|143012290|SUPERIORITY||Difference in LS means|-12.1|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|98.0|-19.1|-5.0||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.0|-19.1|<0.001
71754814|NCT03337308|143012291|SUPERIORITY||Difference of LS means|-27.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|99.0|-35.1|-19.1||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-19.1|-35.1|<0.001
71754815|NCT03337308|143012291|SUPERIORITY||Difference of LS means|-14.2|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|98.0|-20.4|-8.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-8.1|-20.4|<0.001
71754816|NCT03337308|143012291|SUPERIORITY||Difference of LS means|-10.4|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|98.0|-16.1|-4.6||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-4.6|-16.1|<0.001
71787737|NCT03247530|143073222|SUPERIORITY||Least Square Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.046||0.002|TWO_SIDED|95.0|-0.26|-0.08|||ANCOVA|||||-0.08|-0.26|0.0020
71787738|NCT03247530|143073223|SUPERIORITY||Risk Difference (RD)|14.5||||0.0063|TWO_SIDED|95.0|4.3|24.6|||Regression, Logistic|||||24.6|4.3|0.0063
71787739|NCT03247530|143073223|SUPERIORITY||Risk Difference (RD)|21.5|||<|0.0001|TWO_SIDED|95.0|11.3|31.6|||Regression, Logistic|||||31.6|11.3|<0.0001
71787740|NCT03247530|143073224|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9974|TWO_SIDED|95.0|-4.5|4.5|||ANCOVA|||||4.5|-4.5|0.9974
71787741|NCT03247530|143073224|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.26||0.4557|TWO_SIDED|95.0|-6.1|2.7|||ANCOVA|||||2.7|-6.1|0.4557
71787742|NCT03247530|143073225|SUPERIORITY||Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.85||0.0006|TWO_SIDED|95.0|-4.6|-1.2|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.2|-4.6|0.0006
71787743|NCT03247530|143073225|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-5.2|-1.9|||ANCOVA|||This statistical analysis pertains to the Inattention subscale score||-1.9|-5.2|<0.0001
71787744|NCT03247530|143073225|SUPERIORITY||Least Square Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.83||0.0026|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.9|-4.1|0.0026
71787745|NCT03247530|143073225|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-4.8|-1.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-1.7|-4.8|<0.0001
71787746|NCT03247530|143073226|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.1292|TWO_SIDED|95.0|-4.2|0.5|||ANCOVA|||||0.5|-4.2|0.1292
71754817|NCT03337308|143012292|SUPERIORITY||Difference of LS means|-30.1|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|99.0|-39.9|-20.3||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means|||-20.3|-39.9|<0.001
71754818|NCT03337308|143012292|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|3.23|<|0.001|TWO_SIDED|98.0|-20.3|-5.3||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-5.3|-20.3|<0.001
71754819|NCT03337308|143012292|SUPERIORITY||Difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.09||0.003|TWO_SIDED|98.0|-16.5|-2.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means|||-2.1|-16.5|0.003
71754820|NCT03341299|143012305|SUPERIORITY||Ratio of geometric least square means|0.991||||0.7734|TWO_SIDED|95.0|0.932|1.05|||Mixed Models Analysis|||||1.05|0.932|0.7734
71754821|NCT03341299|143012306|SUPERIORITY||difference in LS means|-14.5||||0.719|TWO_SIDED|95.0|-94.38|65.38|||Mixed Models Analysis|||||65.38|-94.38|0.7190
71892070|NCT00332202|143305646|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.775||||0.084|TWO_SIDED|95.0|0.947|3.329|||Regression, Cox|||||3.329|0.947|0.084
71754822|NCT00303069|143012316|SUPERIORITY_OR_OTHER||Risk Difference (RD)|84.5|||<|0.001|TWO_SIDED|95.0|65.2|93.6||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||93.6|65.2|<0.001
71754823|NCT00303069|143012316|SUPERIORITY_OR_OTHER||Risk Difference (RD)|81.6|||<|0.01|TWO_SIDED|95.0|61.6|92.0||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||92.0|61.6|<0.01
71754824|NCT00303069|143012316|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0|||<|0.001|TWO_SIDED|95.0|6.7|43.8||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||43.8|6.7|<0.001
71754825|NCT00303069|143012317|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.9|||<|0.001|TWO_SIDED|95.0|17.2|48.3||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||48.3|17.2|<0.001
71754826|NCT00303069|143012317|SUPERIORITY_OR_OTHER||Risk Difference (RD)|14.4|||<|0.001|TWO_SIDED|95.0|1.6|32.1||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||32.1|1.6|<0.001
71754827|NCT00303069|143012317|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||<|0.001|TWO_SIDED|95.0|-8.2|16.9||P-value \< 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (\<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.||16.9|-8.2|<0.001
71892071|NCT00332202|143305646|SUPERIORITY||Hazard Ratio (HR)|1.286||||0.585|TWO_SIDED|95.0|0.527|3.137|||Regression, Cox|||||3.137|0.527|0.585
71754828|NCT01972217|143012330|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.017|TWO_SIDED|95.0|0.438|0.969|||Log Rank|||The 1-sided p-value provides a test for rejecting the null hypothesis of no treatment effect versus the superiority alternative that patients on olaparib have a lower risk of progression compared with placebo.||0.969|0.438|0.017
71754829|NCT01972217|143012343|OTHER||Odds Ratio (OR)|0.813||||0.309|TWO_SIDED|95.0|0.285|2.261||The p value was calculated with a 1-sided significance level of 2.5%.|Regression, Logistic|||||2.261|0.285|0.309
71892072|NCT03871491|143305648|SUPERIORITY||Risk Ratio (RR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.79||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of maternal death or sepsis within 6 weeks (42 days) post-delivery||0.79|0.56|<0.001
71892073|NCT03871491|143305649|SUPERIORITY||Risk Ratio (RR)|1.02||||0.56|TWO_SIDED|95.0|0.95|1.09||We calculated P values to test each of the primary hypotheses at an alpha level of 0.05 overall, with a nominal alpha level of 0.0001 at the interim analysis.|Regression, Logistic|Used multiple imputation for missing outcomes by means of logistic regression imputation.||The null hypothesis is there is no treatment effect on the incidence of Intrapartum/Neonatal Death or Sepsis Within 4 Weeks (28 Days) Post-delivery in Intervention vs. Placebo Group||1.09|0.95|0.56
71892074|NCT03871491|143305650|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.55|0.77||||||||0.77|0.55|
71892075|NCT03871491|143305651|SUPERIORITY||Risk Ratio (RR)|4.04|||||TWO_SIDED|95.0|0.45|36.14||||||||36.14|0.45|
71670925|NCT03504397|142859669|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.1685|TWO_SIDED|95.0|0.874|1.492|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.492|0.874|0.1685
71754830|NCT01972217|143012344|OTHER||Hazard Ratio (HR)|0.781||||0.095|TWO_SIDED|95.0|0.54|1.13||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olapatib + abiraterone versus placebo + abiraterone: TFST||1.130|0.540|0.095
71754831|NCT01972217|143012344|OTHER||Hazard Ratio (HR)|0.809||||0.147|TWO_SIDED|95.0|0.545|1.201||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olaparib + abiraterone versus placebo + abiraterone: TSST||1.201|0.545|0.147
71754832|NCT01972217|143012345|OTHER||Hazard Ratio (HR)|0.911||||0.331|TWO_SIDED|95.0|0.6|1.384||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.384|0.600|0.331
71754833|NCT01972217|143012346|OTHER||Hazard Ratio (HR)|0.788||||0.14|TWO_SIDED|95.0|0.511|1.215||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||||1.215|0.511|0.140
71754834|NCT02958917|143012347|SUPERIORITY||Mean Difference (Final Values)|-0.76|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71892076|NCT03871491|143305653|SUPERIORITY||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.55|0.79||||||||0.79|0.55|
71892077|NCT03871491|143305654|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.43|0.75||||||||0.75|0.43|
71892078|NCT03871491|143305655|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.65|0.99||||||||0.99|0.65|
71892079|NCT03871491|143305656|SUPERIORITY||Risk Ratio (RR)|0.69|||||TWO_SIDED|95.0|0.56|0.85||||||||0.85|0.56|
71670926|NCT03504397|142859670|SUPERIORITY|||||||0.4536|||||||Cochran-Mantel-Haenszel|Based on 1-sided Cochran-Mantel-Haenszel (CMH) test. Stratification factors were Region, Number of Metastatic Sites and Prior Gastrectomy.||||||0.4536
71892080|NCT03871491|143305657|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.95|1.01||||||||1.01|0.95|
71892081|NCT03871491|143305659|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.52|0.82||||||||0.82|0.52|
71892082|NCT03871491|143305660|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15||||||||1.15|0.70|
71892083|NCT03871491|143305661|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.73|0.84||||||||0.84|0.73|
71892084|NCT03871491|143305662|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41||||||||1.41|0.84|
71892085|NCT03871491|143305663|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.96|1.1||||||||1.1|0.96|
71892086|NCT03871491|143305664|SUPERIORITY||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.73|1.47||||||||1.47|0.73|
71670927|NCT03504397|142859671|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.0721|TWO_SIDED|95.0|0.573|1.087|||Log Rank||"Log-rank test stratified by:~* Region (Asia vs Non-Asia)~* Number of organs with metastatic sites (0 to 2 vs ≥ 3)~* Prior gastrectomy (Yes or No)"|||1.087|0.573|0.0721
71754835|NCT02958917|143012348|SUPERIORITY||Cox Proportional Hazard|0.264|||<|0.05|TWO_SIDED|95.0|||||Regression, Cox|||||||<0.05
71754836|NCT02958917|143012349|SUPERIORITY||Slope|2.03|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754837|NCT02958917|143012350|SUPERIORITY||Median Difference (Final Values)|-0.108|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754838|NCT02958917|143012351|SUPERIORITY||Risk Difference (RD)|0.364|||<|0.05|TWO_SIDED||||||Log Rank|||||||<0.05
71754839|NCT02958917|143012352|SUPERIORITY||Risk Difference (RD)|0.128|||<|0.05|TWO_SIDED|95.0|||||Log Rank|||||||<0.05
71754840|NCT02958917|143012353|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754841|NCT02958917|143012354|SUPERIORITY||Mean Difference (Final Values)|-6.72|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754842|NCT02958917|143012355|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754843|NCT02958917|143012356|SUPERIORITY||Mean Difference (Final Values)|-7.92|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754844|NCT02958917|143012357|SUPERIORITY||Mean Difference (Final Values)|-2.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71754845|NCT02364700|143012358|EQUIVALENCE|Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.|||||<|0.05|||||||Friedman Test|||||||<.05
71754846|NCT00804908|143012364|SUPERIORITY_OR_OTHER||||||=|0.071|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.071
71892087|NCT03871491|143305665|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.88|1.07||||||||1.07|0.88|
71892088|NCT03871491|143305667|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.96|1.21||||||||1.21|0.96|
71892089|NCT03871491|143305668|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.94|1.12||||||||1.12|0.94|
71892090|NCT03871491|143305669|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.93|1.0||||||||1.0|0.93|
71892091|NCT03871491|143305670|SUPERIORITY||Risk Ratio (RR)|2.68|||||TWO_SIDED|95.0|0.71|10.1||||||||10.1|0.71|
71892092|NCT00490542|143305690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||||TWO_SIDED|95.0|0.6|10.2||||||||10.2|0.6|
71892093|NCT03658954|143305691|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Testing for group effect.||||0.75
71670928|NCT01662635|142859680|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student's t test. The x2 or Fisher's exact tests were used to assess significance among categorical variables.||||< 0.05
71670929|NCT00611923|142859692|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.57|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 1 between flutamide and placebo groups||||= 0.57
71670930|NCT00611923|142859692|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.27|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 2 between flutamide and placebo groups.||||= .27
71670931|NCT00611923|142859693|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.52|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 1 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.52
71670932|NCT00611923|142859693|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 2 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.||||= 0.2
71670933|NCT00611923|142859694|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.8|||||||t-test, 2 sided|||||||= 0.8
71754847|NCT00804908|143012364|SUPERIORITY_OR_OTHER||||||=|0.233|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; \>1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.||||=0.233
71754848|NCT01280903|143012372|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71787747|NCT03247530|143073226|SUPERIORITY||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|1.19||0.3447|TWO_SIDED|95.0|-3.4|1.2|||ANCOVA|||||1.2|-3.4|0.3447
71670934|NCT00611923|142859694|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1|||||||t-test, 2 sided|||||||= 0.1
71670935|NCT00611923|142859695|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.15|||||||t-test, 2 sided|||paired t-test was performed comparing the Clinical Global Improvement score at month 1 between placebo and flutamide groups||||=.15
71892094|NCT03658954|143305692|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Testing for group effect.||||0.05
71670936|NCT00611923|142859695|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.05|||||||t-test, 2 sided|||t-test was performed comparing the Clinical Global Improvement score at month 2 between placebo and flutamide groups||||= .05
71670937|NCT00611923|142859696|SUPERIORITY_OR_OTHER_LEGACY|Comparison of change from baseline score to treatment month 1 between placebo and flutamide treated subjects.|||||=|0.5|||||||t-test, 2 sided|||||||=0.5
71670938|NCT00611923|142859696|SUPERIORITY_OR_OTHER_LEGACY|paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups|||||<|0.04|||||||t-test, 2 sided|||||||<.04
71670939|NCT00611923|142859697|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|||||||t-test, 2 sided|||paired t-test was performed comparing the Patient Global Improvement score at month 1 between placebo and flutamide groups||||=0.2
71670940|NCT00611923|142859697|SUPERIORITY_OR_OTHER_LEGACY|paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups|||||=|0.06|||||||t-test, 2 sided|||||||=0.06
71670941|NCT00838903|142859698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91|||||TWO_SIDED|95.0|-1.16|-0.65|||ANCOVA|||||-0.65|-1.16|
71670942|NCT00838903|142859698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.53|-0.17|||ANCOVA|||||-0.17|-0.53|
71670943|NCT00838903|142859698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.45|-0.09|||ANCOVA|||||-0.09|-0.45|
71670944|NCT00838903|142859698|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value is for superiority testing of albiglutide over placebo at 0.05 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - placebo) is equal to zero||||||<0.0001
71670945|NCT00838903|142859698|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.|t-test, 1 sided|||||||<0.0001
71670946|NCT00838903|142859698|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.|t-test, 1 sided|||||||<0.0001
71670947|NCT00838903|142859698|SUPERIORITY_OR_OTHER|||||||0.0001||||||The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - sitagliptin) is equal to zero.||||||0.0001
71670948|NCT00838903|142859698|SUPERIORITY_OR_OTHER|||||||0.0033||||||The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.||||||0.0033
71670949|NCT03096314|142859707|SUPERIORITY|||||||0.26|||||||Generalized linear model|||||||0.26
71670950|NCT03096314|142859708|SUPERIORITY||Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-0.1|8.6||||||||8.6|-0.1|
71670951|NCT03096314|142859709|SUPERIORITY||Risk Difference (RD)|3.7|||||TWO_SIDED|95.0|-0.5|8.0||||||||8.0|-0.5|
71670952|NCT03096314|142859710|SUPERIORITY||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-5.4|6.0||||||||6.0|-5.4|
71670953|NCT03096314|142859711|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-2.7|0.0||||||||0.0|-2.7|
71754849|NCT01280903|143012373|SUPERIORITY|||||||0.13||||||p=0.130 for None to very low|Mixed Models Analysis|||||||0.130
71754850|NCT01280903|143012373|SUPERIORITY|||||||0.573||||||p=0.573 for Light|Mixed Models Analysis|||||||0.573
71754851|NCT01280903|143012373|SUPERIORITY|||||||0.197||||||p=0.197 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.197
71754852|NCT01280903|143012374|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||||||0.461
71754853|NCT01280903|143012375|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.180
71754854|NCT01280903|143012376|SUPERIORITY|||||||0.258|||||||Mixed Models Analysis|||||||0.258
71787748|NCT03247530|143073227|SUPERIORITY|||||||0.0005|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.0005
71787749|NCT03247530|143073227|SUPERIORITY|||||||0.0212|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0212
71754855|NCT01280903|143012377|SUPERIORITY|||||||0.416|||||||Mixed Models Analysis|||||||0.416
71754856|NCT01280903|143012378|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71754857|NCT01280903|143012379|SUPERIORITY|||||||0.272||||||p=0.272 for None to very low|Mixed Models Analysis|||||||0.272
71754858|NCT01280903|143012379|SUPERIORITY|||||||0.823||||||p=0.823 for Light|Mixed Models Analysis|||||||0.823
71754859|NCT01280903|143012379|SUPERIORITY|||||||0.076||||||p=0.076 for Moderate-to-vigorous|Mixed Models Analysis|||||||0.076
71787750|NCT03247530|143073227|SUPERIORITY|||||||0.0115|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0115
71787751|NCT03247530|143073227|SUPERIORITY|||||||0.0027|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0027
71787752|NCT03247530|143073227|SUPERIORITY|||||||0.0066|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0066
71787753|NCT03247530|143073227|SUPERIORITY|||||||0.0065|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0065
71892095|NCT03658954|143305693|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Testing for group effect.||||0.02
71787754|NCT03247530|143073227|SUPERIORITY|||||||0.5826|||||||Chi-squared|||This analysis pertains to Week 1 of treatment||||0.5826
71787755|NCT03247530|143073227|SUPERIORITY|||||||0.0099|||||||Chi-squared|||This analysis pertains to Week 2 of treatment||||0.0099
71787756|NCT03247530|143073227|SUPERIORITY|||||||0.0225|||||||Chi-squared|||This analysis pertains to Week 3 of treatment||||0.0225
71892096|NCT02863198|143305708|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71754860|NCT01280903|143012380|SUPERIORITY|||||||0.561|||||||Mixed Models Analysis|||||||0.561
71754861|NCT01280903|143012381|SUPERIORITY|||||||0.856|||||||Mixed Models Analysis|||||||0.856
71754862|NCT01280903|143012382|SUPERIORITY|||||||0.292|||||||Mixed Models Analysis|||||||0.292
71787757|NCT03247530|143073227|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 4 of treatment||||0.0008
71754863|NCT01280903|143012383|SUPERIORITY|||||||0.396|||||||Mixed Models Analysis|||||||0.396
71754864|NCT01280903|143012384|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.424
71754865|NCT01280903|143012385|SUPERIORITY|||||||0.586|||||||Mixed Models Analysis|||||||0.586
71754866|NCT01280903|143012386|SUPERIORITY|||||||0.596|||||||Mixed Models Analysis|||||||0.596
71754867|NCT01280903|143012387|SUPERIORITY|||||||0.639|||||||Mixed Models Analysis|||||||0.639
71754868|NCT01280903|143012388|SUPERIORITY|||||||0.466|||||||Mixed Models Analysis|||||||0.466
71754869|NCT01280903|143012389|SUPERIORITY|||||||0.322||||||p=0.322 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.322
71754870|NCT01280903|143012389|SUPERIORITY|||||||0.979||||||p=0.979 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.979
71754871|NCT01280903|143012390|SUPERIORITY|||||||0.71||||||p=0.710 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.710
71754872|NCT01280903|143012390|SUPERIORITY|||||||0.133||||||p=0.133 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.133
71754873|NCT01280903|143012391|SUPERIORITY|||||||0.005||||||p=0.005 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.005
71754874|NCT01280903|143012391|SUPERIORITY|||||||0.948||||||p=0.948 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.948
71754875|NCT01280903|143012391|SUPERIORITY|||||||0.663||||||p=0.663 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.663
71754876|NCT01280903|143012392|SUPERIORITY|||||||0.001||||||p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.001
71754877|NCT01280903|143012392|SUPERIORITY|||||||0.031||||||p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension|Mixed Models Analysis|||||||0.031
71754878|NCT01280903|143012393|SUPERIORITY|||||||0.816|||||||Mixed Models Analysis|||||||0.816
71754879|NCT01280903|143012394|SUPERIORITY|||||||0.895|||||||Mixed Models Analysis|||||||0.895
71754880|NCT01280903|143012395|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|||||||0.260
71754881|NCT01280903|143012396|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
71787758|NCT03247530|143073227|SUPERIORITY|||||||0.002|||||||Chi-squared|||This analysis pertains to Week 5 of treatment||||0.0020
71787759|NCT03247530|143073227|SUPERIORITY|||||||0.0002|||||||Chi-squared|||This analysis pertains to Week 6 of treatment||||0.0002
71787760|NCT01124422|143073228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.6|STANDARD_ERROR_OF_MEAN|20.58||0.181|TWO_SIDED|95.0|-68.2|13.0||ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value|ANCOVA|||||13.0|-68.2|0.181
71787761|NCT02959944|143073247|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
71787762|NCT02959944|143073248|SUPERIORITY||Difference in Rates|0.043||||0.5384|TWO_SIDED|95.0|-0.094|0.181||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.181|-0.094|0.5384
71787763|NCT02959944|143073249|SUPERIORITY|||||||0.324||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.324
71787764|NCT02959944|143073250|SUPERIORITY|||||||0.281||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.281
71787765|NCT02959944|143073251|SUPERIORITY|||||||0.275||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.275
71787766|NCT02959944|143073252|SUPERIORITY|||||||0.216||||||Gray's chi-square test (p-value) was calculated using SAS lifetest procedure adjusting for competing risks including death, cGVHD progression, relapse of underlying disease, and start of subsequent cGVHD therapy.|Chi-squared|||||||0.216
71787767|NCT02959944|143073253|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
71754882|NCT01280903|143012397|SUPERIORITY|||||||0.947|||||||Mixed Models Analysis|||||||0.947
71754883|NCT01280903|143012398|SUPERIORITY|||||||0.406||||||p=0.406 for Short Form-36v2 Mental Component|Mixed Models Analysis|||||||0.406
71754884|NCT01280903|143012398|SUPERIORITY|||||||0.826||||||p=0.826 for Short Form-36v2 Physical Component|Mixed Models Analysis|||||||0.826
71754885|NCT01280903|143012399|SUPERIORITY|||||||0.95||||||p=0.950 for Exercise Barriers Self-Efficacy|Mixed Models Analysis|||||||0.950
71754886|NCT01280903|143012399|SUPERIORITY|||||||0.365||||||p=0.365 for Exercise Self-Efficacy|Mixed Models Analysis|||||||0.365
71754887|NCT01280903|143012400|SUPERIORITY|||||||0.219||||||p=0.219 for Arthritis Self Efficacy Pain|Mixed Models Analysis|||||||0.219
71754888|NCT01280903|143012400|SUPERIORITY|||||||0.34||||||p=0.340 for Arthritis Self Efficacy Function|Mixed Models Analysis|||||||0.340
71754889|NCT01280903|143012400|SUPERIORITY|||||||0.806||||||p=0.806 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis|||||||0.806
71754890|NCT01280903|143012401|SUPERIORITY|||||||0.008||||||p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis|||||||0.008
71754891|NCT01280903|143012401|SUPERIORITY|||||||0.12||||||p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension|t-test, 1 sided|||||||0.120
71837165|NCT03924986|143180959|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.05|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|||1.05|0.51|
71754892|NCT01968447|143012427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71670954|NCT03096314|142859712|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.8|0.4||||||||0.4|-4.8|
71754893|NCT02766023|143012434|SUPERIORITY||Risk Difference (RD)|0.04||||0.467|TWO_SIDED|95.0|-0.1|0.18|||Fisher Exact|||||0.18|-0.10|0.467
71754894|NCT02766023|143012435|SUPERIORITY||Odds Ratio (OR)|0.54||||0.031|TWO_SIDED|95.0|0.3|0.95|||Chi-squared|||||0.95|0.30|0.031
71754895|NCT02766023|143012436|SUPERIORITY||Risk Difference (RD)|0.03||||0.643|TWO_SIDED|95.0|-0.08|0.15|||Chi-squared|||Analysis is for self-reported compliance||0.15|-0.08|0.643
71754896|NCT02766023|143012436|SUPERIORITY||Risk Difference (RD)|0.05||||0.446|TWO_SIDED|95.0|-0.07|0.17|||Chi-squared|||Analysis is for compliance assessed by staining.||0.17|-0.07|0.446
71754897|NCT02766023|143012445|SUPERIORITY||Odds Ratio (OR)|79.64|||<|0.001|TWO_SIDED|95.0|29.02|218.57|||Chi-squared|||||218.57|29.02|<0.001
71754898|NCT02766023|143012453|SUPERIORITY||Odds Ratio (OR)|72.78|||<|0.001|TWO_SIDED|95.0|28.07|188.66|||Chi-squared|||||188.66|28.07|<0.001
71754899|NCT02766023|143012454|SUPERIORITY||Odds Ratio (OR)|0.54||||0.03|TWO_SIDED|95.0|0.31|0.94|||Chi-squared|||||0.94|0.31|0.030
71754900|NCT04026113|143012466|SUPERIORITY||Difference|1.17|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|95.0|0.651|1.689||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||1.689|0.651|< 0.0001
71754901|NCT04026113|143012466|SUPERIORITY|||||||0.4323||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4323
71754902|NCT04026113|143012468|SUPERIORITY||Difference|0.423|STANDARD_ERROR_OF_MEAN|0.109||0.0001|TWO_SIDED|95.0|0.208|0.638||ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA|||||0.638|0.208|0.0001
71754903|NCT04026113|143012468|SUPERIORITY|||||||0.4381||||||Treatment-by-Age Group Interaction P-value: Interaction P-value base on ANCOVA model with treatment, age group, treatment-by-age group interaction as factors and baseline value as a covariate.|ANCOVA|||||||0.4381
71892097|NCT02863198|143305709|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71670955|NCT03096314|142859713|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-2.1|0.5||||||||0.5|-2.1|
71670956|NCT03096314|142859714|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|0|
71754904|NCT04613362|143012486|SUPERIORITY||Odds Ratio (OR)|0.82||||0.61|TWO_SIDED|95.0|0.34|1.97||adjusted for gender which is included as a covariate|Mixed Models Analysis|||||1.97|0.34|0.61
71754905|NCT04613362|143012488|SUPERIORITY||Mean Difference (Net)|-8.8028|STANDARD_ERROR_OF_MEAN|6.3895||0.1724|TWO_SIDED|95.0|-21.5314|3.9257|||Mixed Models Analysis|||3 month||3.9257|-21.5314|0.1724
71754906|NCT04613362|143012488|SUPERIORITY||Mean Difference (Net)|-4.6533|STANDARD_ERROR_OF_MEAN|5.9929||0.4399|TWO_SIDED|95.0|-16.5917|7.2851|||Mixed Models Analysis|||6 months||7.2851|-16.5917|0.4399
71754907|NCT04613362|143012489|SUPERIORITY||Mean Difference (Net)|18.7886|STANDARD_ERROR_OF_MEAN|18.0826||0.3021|TWO_SIDED|95.0|-17.2261|54.8032|||Mixed Models Analysis|||3 months||54.8032|-17.2261|0.3021
71754908|NCT04613362|143012489|SUPERIORITY||Mean Difference (Net)|-5.1996|STANDARD_ERROR_OF_MEAN|17.1338||0.7624|TWO_SIDED|95.0|-39.3245|28.9254|||Mixed Models Analysis|||6 months||28.9254|-39.3245|0.7624
71754909|NCT04613362|143012490|SUPERIORITY||Mean Difference (Net)|5.9613|STANDARD_ERROR_OF_MEAN|4.3867||0.1783|TWO_SIDED|95.0|-2.7794|14.7019|||Mixed Models Analysis|||3 months||14.7019|-2.7794|0.1783
71754910|NCT04613362|143012490|SUPERIORITY||Mean Difference (Net)|-0.2145|STANDARD_ERROR_OF_MEAN|4.1565||0.959|TWO_SIDED|95.0|-8.4965|8.0675|||Mixed Models Analysis|||6 months||8.0675|-8.4965|0.959
71754911|NCT04613362|143012491|SUPERIORITY||Mean Difference (Net)|-12.6627|STANDARD_ERROR_OF_MEAN|7.3097||0.0873|TWO_SIDED|95.0|-27.2243|1.8989|||Mixed Models Analysis|||3 months||1.8989|-27.2243|0.0873
71754912|NCT04613362|143012491|SUPERIORITY||Mean Difference (Net)|-7.3578|STANDARD_ERROR_OF_MEAN|6.8559||0.2866|TWO_SIDED|95.0|-21.0154|6.2999|||Mixed Models Analysis|||6 months||6.2999|-21.0154|0.2866
71754913|NCT04613362|143012493|SUPERIORITY||Mean Difference (Net)|-1.5655|STANDARD_ERROR_OF_MEAN|1.4313||0.2776|TWO_SIDED|95.0|-4.4168|1.2859|||Mixed Models Analysis|||3 months||1.2859|-4.4168|0.2776
71754914|NCT04613362|143012493|SUPERIORITY||Mean Difference (Net)|0.7202|STANDARD_ERROR_OF_MEAN|1.6492||0.6636|TWO_SIDED|95.0|-2.5651|4.0055|||Mixed Models Analysis|||6 months||4.0055|-2.5651|0.6636
71754915|NCT04613362|143012494|SUPERIORITY||Mean Difference (Net)|2.3254|STANDARD_ERROR_OF_MEAN|1.6911||0.1733|TWO_SIDED|95.0|-1.0443|5.695|||Mixed Models Analysis|||3 months||5.695|-1.0443|0.1733
71754916|NCT04613362|143012494|SUPERIORITY||Mean Difference (Net)|-0.5408|STANDARD_ERROR_OF_MEAN|1.622||0.7398|TWO_SIDED|95.0|-3.7726|2.6911|||Mixed Models Analysis|||6 months||2.6911|-3.7726|0.7398
71670957|NCT03096314|142859715|SUPERIORITY||Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-2.1|3.6||||||||3.6|-2.1|
71754917|NCT04613362|143012495|SUPERIORITY||Mean Difference (Net)|-0.1491|STANDARD_ERROR_OF_MEAN|1.5551||0.9239|TWO_SIDED|95.0|-3.2476|2.9494|||Mixed Models Analysis|||Physical Component Scale - 3 months||2.9494|-3.2476|0.9239
71754918|NCT04613362|143012495|SUPERIORITY||Mean Difference (Net)|-0.2879|STANDARD_ERROR_OF_MEAN|1.4735||0.8456|TWO_SIDED|95.0|-3.2238|2.6481|||Mixed Models Analysis|||Physical Component Scale - 6 months||2.6481|-3.2238|0.8456
71754919|NCT04613362|143012495|SUPERIORITY||Mean Difference (Net)|-0.1757|STANDARD_ERROR_OF_MEAN|2.3798||0.9413|TWO_SIDED|95.0|-4.9175|4.5661|||Mixed Models Analysis|||Mental Component Scale - 3 months||4.5661|-4.9175|0.9413
71754920|NCT04613362|143012495|SUPERIORITY||Mean Difference (Net)|-2.9597|STANDARD_ERROR_OF_MEAN|2.2549||0.1934|TWO_SIDED|95.0|-7.4526|1.5333|||Mixed Models Analysis|||Mental Component Scale - 6 months||1.5333|-7.4526|0.1934
71837166|NCT03924986|143180960|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.76|||||Estimated using a Cox proportional hazards model with Efron's method for tied events, with Arm B as the reference group. The analysis was stratified by gender and liver metastases status.|The null hypothesis to be tested is that progression-free survival (PFS) in Arm A is less than or equal to PFS in Arm B. This is compared against the alternative hypothesis, which posits that PFS in Arm A is greater than PFS in Arm B.||0.76|0.38|
71837167|NCT03665597|143180991|OTHER|Geometric Least-Square Mean Ratio (GMR) = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.73|||||TWO_SIDED|90.0|0.68|0.78||||||||0.78|0.68|
71754921|NCT04613362|143012496|SUPERIORITY||Mean Difference (Net)|3.0999|STANDARD_ERROR_OF_MEAN|2.1004||0.1442|TWO_SIDED|95.0|-1.0852|7.2849|||Mixed Models Analysis|||3 months||7.2849|-1.0852|0.1442
71754922|NCT04613362|143012496|SUPERIORITY||Mean Difference (Net)|2.0675|STANDARD_ERROR_OF_MEAN|2.036||0.3132|TWO_SIDED|95.0|-1.9892|6.1243|||Mixed Models Analysis|||6 months||6.1243|-1.9892|0.3132
71754923|NCT02218372|143012499|OTHER||adjusted treatment difference|7.5|||||TWO_SIDED|95.0|-7.4|23.9||||||Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.||23.9|-7.4|
71754924|NCT02218372|143012500|OTHER||adjusted treatment difference|16.3|||||TWO_SIDED|95.0|1.8|34.2||||||Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.2|1.8|
71754925|NCT02218372|143012501|OTHER||adjusted treatment difference|21.3|||||TWO_SIDED|95.0|4.5|37.7||||||Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||37.7|4.5|
71754926|NCT02218372|143012502|OTHER||adjusted treatment difference|-16.3|||||TWO_SIDED|95.0|-34.2|-1.8||||||Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.8|-34.2|
71787768|NCT02959944|143073254|SUPERIORITY||Difference in Rates|-0.067||||0.351|TWO_SIDED|95.0|-0.208|0.074||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.074|-0.208|0.3510
71787769|NCT02959944|143073255|SUPERIORITY||Difference in Rates|0.124||||0.0659|TWO_SIDED|95.0|-0.007|0.256||P-value is computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval is computed using normal approximation.|||0.256|-0.007|0.0659
71837168|NCT03665597|143180991|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|GMR|0.69|||||TWO_SIDED|90.0|0.64|0.74||||||||0.74|0.64|
71754927|NCT02218372|143012503|OTHER||adjusted treatment difference|17.2|||||TWO_SIDED|95.0|1.9|35.6||||||Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.6|1.9|
71754928|NCT02218372|143012504|OTHER||adjusted treatment difference|19.4|||||TWO_SIDED|95.0|2.3|35.9||||||Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.9|2.3|
71754929|NCT02218372|143012505|OTHER||adjusted treatment difference|-17.2|||||TWO_SIDED|95.0|-35.6|-1.9||||||Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||-1.9|-35.6|
71754930|NCT02218372|143012506|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
71754931|NCT02218372|143012507|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
71787770|NCT02959944|143073256|SUPERIORITY||Difference in Rates|0.125||||0.0708|TWO_SIDED|95.0|-0.01|0.261||P-value is computed using non-stratified Chi-Square test.|Chi-squared|||||0.261|-0.010|0.0708
71787771|NCT02959944|143073257|SUPERIORITY||Difference in Rates|-0.059||||0.4064|TWO_SIDED|95.0|-0.199|0.08||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.080|-0.199|0.4064
71837169|NCT03665597|143180992|OTHER|GMR = GM of Pembrolizumab 130 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.4|||||TWO_SIDED|90.0|0.36|0.44||||||||0.44|0.36|
71670958|NCT03096314|142859716|SUPERIORITY||Risk Difference (RD)|6.5|||||TWO_SIDED|95.0|-22.0|34.9||||||Mild ARDS||34.9|-22.0|
71670959|NCT03096314|142859716|SUPERIORITY||Risk Difference (RD)|-25.6|||||TWO_SIDED|95.0|-56.3|5.1||||||Moderate ARDS||5.1|-56.3|
71670960|NCT03096314|142859716|SUPERIORITY||Risk Difference (RD)|19.1|||||TWO_SIDED|95.0|-2.9|41.1||||||Severe ARDS||41.1|-2.9|
71670961|NCT03096314|142859717|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-7.3|5.0||||||No AKI||5.0|-7.3|
71670962|NCT03096314|142859717|SUPERIORITY||Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-5.6|3.4||||||Mild AKI||3.4|-5.6|
71670963|NCT03096314|142859717|SUPERIORITY||Risk Difference (RD)|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Moderate AKI||3.2|-4.4|
71670964|NCT03096314|142859717|SUPERIORITY||Risk Difference (RD)|2.8|||||TWO_SIDED|95.0|-1.7|7.3||||||Severe AKI||7.3|-1.7|
71670965|NCT03096314|142859718|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-1.9|2.9||||||||2.9|-1.9|
71754932|NCT02218372|143012508|OTHER||adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
71754933|NCT02218372|143012509|OTHER||adjusted treatment difference|15.8|||||TWO_SIDED|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||34.5|-0.5|
71754934|NCT02218372|143012510|OTHER||adjusted treatment difference|18.8|||||TWO_SIDED|95.0|1.5|35.3||||||Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||35.3|1.5|
71787772|NCT02959944|143073258|SUPERIORITY||Difference in Rates|-0.049||||0.4955|TWO_SIDED|95.0|-0.188|0.091||P-value was computed using non-stratified Chi-Square test.|Chi-squared||Confidence interval was computed using normal approximation.|||0.091|-0.188|0.4955
71787773|NCT02959944|143073259|SUPERIORITY||Hazard Ratio (HR)|0.994|||||TWO_SIDED|95.0|0.507|1.949|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.949|0.507|
71787774|NCT02959944|143073260|SUPERIORITY||Hazard Ratio (HR)|1.061|||||TWO_SIDED|95.0|0.591|1.904|||||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|||1.904|0.591|
71670966|NCT03096314|142859719|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
71754935|NCT02218372|143012511|OTHER|Newcombe 95% CIs presented for adjusted treatment difference.|adjusted treatment difference|-15.8|||||TWO_SIDED|95.0|-34.5|0.5||||||Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.||0.5|-34.5|
71754936|NCT02218372|143012512|OTHER|||||||0.579|||||||Log Rank|||Time to resolution of diarrhea.||||0.579
71892098|NCT02863198|143305710|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
71670967|NCT03096314|142859720|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-4.4|5.1||||||||5.1|-4.4|
71754937|NCT02218372|143012513|OTHER|||||||0.023|||||||Log Rank|||Time to recurrence of CDAD.||||0.023
71754938|NCT02753283|143012522|SUPERIORITY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.48||0.007|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.007
71754939|NCT02753283|143012522|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.09||0.018|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.018
71754940|NCT02753283|143012523|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|1.45||0.014|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.014
71787775|NCT02959944|143073261|SUPERIORITY||Hazard Ratio (HR)|0.697||||0.101|TWO_SIDED|95.0|0.451|1.076|||Regression, Cox|||||1.076|0.451|0.1010
71754941|NCT02753283|143012523|SUPERIORITY||Mean Difference (Final Values)|5.16|STANDARD_ERROR_OF_MEAN|1.45||0.002|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.002
71754942|NCT02753283|143012524|SUPERIORITY||Mean Difference (Final Values)|2.54|STANDARD_ERROR_OF_MEAN|1.26||0.06|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.060
71754943|NCT02753283|143012524|SUPERIORITY||Mean Difference (Final Values)|2.45|STANDARD_ERROR_OF_MEAN|1.22||0.055|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.055
71754944|NCT02753283|143012525|SUPERIORITY||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.37||0.112|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.112
71754945|NCT02753283|143012525|SUPERIORITY||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|1.34||0.07|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.070
71754946|NCT02753283|143012526|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.39||0.904|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.904
71754947|NCT02753283|143012526|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|2.29||0.616|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.616
71787776|NCT02959944|143073262|SUPERIORITY||Hazard Ratio (HR)|0.717||||0.1004|TWO_SIDED|95.0|0.482|1.068|||Regression, Cox|||||1.068|0.482|0.1004
71787777|NCT02288559|143073302|SUPERIORITY||Difference in Adjusted Means|0.435||||0.0428|TWO_SIDED|80.0|0.162|0.707|||Mixed-Effect Model Repeated Measures|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.707|0.162|0.0428
71787778|NCT02288559|143073302|SUPERIORITY||Difference in Adjusted Means|-0.21||||0.3361|TWO_SIDED|80.0|-0.491|0.071|||MMRM|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.||||0.071|-0.491|0.3361
71787779|NCT02320149|143073308|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.7|-3.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-3.6|-6.7|< 0.0001
71837170|NCT03665597|143180992|OTHER|GMR = GM of Pembrolizumab 165 mg/mL SC/GM of Pembrolizumab 200 mg IV|Geometric Least-Square Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.41||||||||0.41|0.34|
71845568|NCT00357994|143205623|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3741|TWO_SIDED|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.9|-0.4|0.3741
71670968|NCT03096314|142859721|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
71670969|NCT03096314|142859722|SUPERIORITY||Mean Difference (Final Values)|35.5|||||TWO_SIDED|95.0|31.5|39.6||||||||39.6|31.5|
71670970|NCT03096314|142859723|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71670971|NCT03096314|142859724|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71670972|NCT03096314|142859725|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71670973|NCT03096314|142859726|SUPERIORITY|||||||0.25|||||||Fisher Exact|||||||0.25
71754948|NCT02753283|143012527|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||<.001
71754949|NCT02753283|143012527|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.03||0.005|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.005
71754950|NCT02753283|143012528|SUPERIORITY||Mean Difference (Final Values)|-26.2|STANDARD_ERROR_OF_MEAN|6.0||0.001|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.001
71754951|NCT02753283|143012528|SUPERIORITY||Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|3.9||0.038|TWO_SIDED||||||Mixed Models Analysis|Using multiple imputation for missing data||||||.038
71754952|NCT04386291|143012529|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.071|TWO_SIDED||||||t-test, 1 sided|||||||0.071
71754953|NCT04386291|143012529|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.46|TWO_SIDED||||||t-test, 1 sided|||||||0.46
71754954|NCT04386291|143012530|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.01|TWO_SIDED||||||t-test, 1 sided|||||||0.01
71754955|NCT04386291|143012530|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.04|TWO_SIDED||||||t-test, 1 sided|||||||0.04
71754956|NCT04386291|143012531|SUPERIORITY||Mean Difference (Final Values)|-1.47||||0.08|TWO_SIDED||||||t-test, 1 sided|||||||0.08
71754957|NCT04386291|143012531|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.5|TWO_SIDED||||||t-test, 1 sided|||||||0.5
71754958|NCT04386291|143012532|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.25|TWO_SIDED||||||t-test, 1 sided|||||||0.25
71754959|NCT04386291|143012532|SUPERIORITY||Mean Difference (Final Values)|-1.54||||0.065|TWO_SIDED||||||t-test, 1 sided|||||||0.065
71754960|NCT04386291|143012533|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.88|TWO_SIDED||||||t-test, 1 sided|||||||0.88
71754961|NCT04386291|143012533|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.7|TWO_SIDED||||||t-test, 1 sided|||||||0.7
71754962|NCT04386291|143012534|SUPERIORITY||Mean Difference (Final Values)|-1.84||||0.038|TWO_SIDED||||||t-test, 1 sided|||||||0.038
71754963|NCT04386291|143012534|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.059|TWO_SIDED||||||t-test, 1 sided|||||||0.059
71754964|NCT04386291|143012535|SUPERIORITY||Median Difference (Final Values)|1.58||||0.9|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.9
71754965|NCT04386291|143012535|SUPERIORITY||Mean Difference (Net)|-0.73||||0.23|TWO_SIDED||||||t-test, 1 sided|||Subpression subscale analysis||||0.23
71837171|NCT00450658|143181028|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||0.0018|TWO_SIDED|95.0|3.0|15.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjects developing UGI (gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative proportion of subjects developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||15.9|3.0|0.0018
71754966|NCT04386291|143012535|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.7|TWO_SIDED||||||t-test, 1 sided|||Reappraisal subscale analysis||||0.7
71754967|NCT04386291|143012535|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED||||||t-test, 1 sided|||Suppression subscale analysis||||0.5
71754968|NCT04386291|143012536|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5|TWO_SIDED||||||ANOVA|||||||0.5
71754969|NCT04386291|143012537|SUPERIORITY||mean rank difference|79.0||||0.076|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann-Witney was used because assumption of normality of variance was violated||||||0.076
71754970|NCT04386291|143012537|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.8|TWO_SIDED||||||t-test, 1 sided|||||||0.8
71754971|NCT05172128|143012538|OTHER||||||>|0.05|||||||t-test, 2 sided||||Paired t-test comparing baseline value to endpoint value revealed a p-value of 0.80.|||>0.05
71754972|NCT05172128|143012539|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71754973|NCT05172128|143012540|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71754974|NCT05172128|143012541|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71754975|NCT05172128|143012544|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71754976|NCT01921205|143012546|SUPERIORITY||Percent reduction over Placebo|31.72|||=|0.0003|TWO_SIDED|95.0|16.342|44.277|||ANCOVA|Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.|Percent reduction over placebo is estimated as 100 x (1-exp\[LSMLacosamide-LSMPlacebo\]). Where LSM is Least Square Mean.|||44.277|16.342|=0.0003
71754977|NCT00412984|143012631|SUPERIORITY|With an average 2.1 years follow-up and assuming a stroke rate of 1.20 per hundred patient-years, \~18,000 randomized subjects allocated in a 1:1 ratio to apixaban or warfarin group would be needed to achieve the desired power. These calculations assumed an incidence of 1% loss to follow-up. Non-inferiority for the primary efficacy endpoint will be assessed first. If non-inferiority (using a NI margin of 1.38) is demonstrated then, superiority for the primary efficacy endpoint will be tested|Hazard Ratio (HR)|0.79||||0.0114|TWO_SIDED|95.0|0.66|0.95||2-sided P-value for superiority test|Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status. (experienced, naïve).|apixaban / warfarin|With 448 subjects with confirmed strokes or systemic emboli, study would have at least 90% power to meet both regulatory definitions of non-inferiority described in the following: (1) the non-inferiority (NI) of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for relative risk (RR) was less than 1.38; (2) the NI of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 99% CI for RR was less than 1.44.||.95|.66|0.0114
71754978|NCT00412984|143012633|SUPERIORITY|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.6|0.8|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|||0.80|0.60|<.0001
71754979|NCT00412984|143012635|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0465|TWO_SIDED|95.0|0.8|1.0|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~1. superiority for the primary efficacy will be tested~2. if superiority for the primary efficacy is~   1. not demonstrated, stop~  2. demonstrated, then superiority for MB will be tested~3. if superiority for MB is~   1. not demonstrated, stop~  2. demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"||1.00|0.80|0.0465
71754980|NCT00412984|143012636|OTHER||Hazard Ratio (HR)|0.92||||0.422|TWO_SIDED|95.0|0.74|1.13||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Ischemic or Unspecified Stroke||1.13|0.74|0.4220
71754981|NCT00412984|143012636|OTHER||Hazard Ratio (HR)|0.51||||0.0006|TWO_SIDED|95.0|0.35|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Hemorrhagic Stroke||0.75|0.35|0.0006
71754982|NCT00412984|143012636|OTHER||Hazard Ratio (HR)|0.87||||0.702|TWO_SIDED|95.0|0.44|1.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Systemic Embolism||1.75|0.44|0.7020
71754983|NCT00412984|143012636|OTHER||Hazard Ratio (HR)|0.88||||0.372|TWO_SIDED|95.0|0.66|1.17||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Myocardial Infarction||1.17|0.66|0.3720
71670974|NCT03096314|142859727|SUPERIORITY|||||||0.69|||||||Chi-squared|||||||0.69
71670975|NCT03096314|142859728|SUPERIORITY|||||||0.24|||||||Chi-squared|||||||0.24
71670976|NCT03003962|142859729|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.84||||0.037|TWO_SIDED|95.0|0.706|0.989|||Stratified Log-rank test||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model|||0.989|0.706|0.037
71670977|NCT03003962|142859730|OTHER|"The analysis was performed using the stratified log-rank test, adjusting for PD-L1 expression (TC 25% to 49% versus \>= 50%) and histology and smoking status (squamous vs. non-squamous + never smoker vs.~non-squamous + former/current smoker) and using the rank tests of association approach."|Hazard Ratio (HR)|0.96||||0.628|TWO_SIDED|95.0|0.793|1.151|||Stratified log-rank test||The HR and CI were calculated using a stratified Cox proportional hazards model.|||1.151|0.793|0.628
71892099|NCT02863198|143305711|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71670978|NCT04242498|142859780|SUPERIORITY||Odds Ratio (OR)|2.422||||0.004|TWO_SIDED|97.5|1.221|4.804|||Regression, Logistic|||||4.804|1.221|0.004
71670979|NCT04242498|142859780|SUPERIORITY||Odds Ratio (OR)|2.287||||0.003|TWO_SIDED|97.5|1.22|4.291|||Regression, Logistic|||||4.291|1.220|0.003
71670980|NCT04242498|142859781|SUPERIORITY||Odds Ratio (OR)|2.722||||0.007|TWO_SIDED|97.5|1.182|6.267|||Regression, Logistic|||||6.267|1.182|0.007
71670981|NCT04242498|142859781|SUPERIORITY||Odds Ratio (OR)|3.007||||0.002|TWO_SIDED|97.5|1.374|6.581|||Regression, Logistic|||||6.581|1.374|0.002
71670982|NCT04242498|142859782|SUPERIORITY||Odds Ratio (OR)|0.798||||0.497|TWO_SIDED|97.5|0.378|1.683|||Regression, Logistic|||||1.683|0.378|0.497
71670983|NCT04242498|142859782|SUPERIORITY||Odds Ratio (OR)|1.05||||0.868|TWO_SIDED|97.5|0.541|2.041|||Regression, Logistic|||||2.041|0.541|0.868
71754984|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding||0.86|0.69|<.0001
71754985|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.89||||0.0192|TWO_SIDED|95.0|0.81|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / All-Cause Death||0.98|0.81|0.0192
71754986|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.85||||0.0002|TWO_SIDED|95.0|0.78|0.92||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding / All-Cause Death||0.92|0.78|0.0002
71754987|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.88||||0.0107|TWO_SIDED|95.0|0.8|0.97||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / MI / All-Cause Death||0.97|0.80|0.0107
71754988|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.9||||0.0432|TWO_SIDED|95.0|0.82|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Ischemic or Unspecified Stroke / All-Cause Death||1.00|0.82|0.0432
71892100|NCT02863198|143305712|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71670984|NCT04242498|142859783|SUPERIORITY||LS mean difference|-2.393|||<|0.001|TWO_SIDED|97.5|-3.92|-0.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.867|-3.920|<0.001
71670985|NCT04242498|142859783|SUPERIORITY||LS mean difference|-2.309|||<|0.001||97.5|-3.705|-0.914||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.914|-3.705|<0.001
71670986|NCT04242498|142859784|SUPERIORITY||LS mean difference|-0.898||||0.01|TWO_SIDED|97.5|-1.684|-0.113||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.113|-1.684|0.010
71670987|NCT04242498|142859784|SUPERIORITY||LS mean difference|-1.265|||<|0.001|TWO_SIDED|97.5|-1.978|-0.552||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|ANCOVA|||||-0.552|-1.978|<0.001
71670988|NCT04242498|142859785|SUPERIORITY||Odds Ratio (OR)|3.273||||0.028|TWO_SIDED|97.5|0.974|10.997||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||10.997|0.974|0.028
71670989|NCT04242498|142859785|SUPERIORITY||Odds Ratio (OR)|3.756||||0.01|TWO_SIDED|97.5|1.189|11.867||Nominal p-value only due to the testing hierarchy failing on the flare outcome.|Regression, Logistic|||||11.867|1.189|0.010
71670990|NCT03380429|142859798|SUPERIORITY||Mean Difference (Final Values)|12.0|||<|0.001|TWO_SIDED|95.0|5.2|18.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||18.8|5.2|<0.001
71670991|NCT03380429|142859799|OTHER||Mean Difference (Final Values)|8.2||||0.016|TWO_SIDED|95.0|1.6|14.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.9|1.6|0.016
71670992|NCT03380429|142859799|OTHER||Mean Difference (Final Values)|9.3||||0.006|TWO_SIDED|95.0|2.7|16.0||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.0|2.7|0.006
71670993|NCT03380429|142859799|OTHER||Mean Difference (Final Values)|8.1||||0.018|TWO_SIDED|95.0|1.4|14.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||14.8|1.4|0.018
71670994|NCT03380429|142859800|OTHER||Mean Difference (Final Values)|9.3||||0.003|TWO_SIDED|95.0|3.2|15.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||15.3|3.2|0.003
71670995|NCT03380429|142859800|OTHER||Mean Difference (Final Values)|7.7||||0.011|TWO_SIDED|95.0|1.8|13.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.7|1.8|0.011
71670996|NCT03380429|142859800|OTHER||Mean Difference (Final Values)|5.5||||0.066|TWO_SIDED|95.0|-0.4|11.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||11.4|-0.4|0.066
71670997|NCT03380429|142859800|OTHER||Mean Difference (Final Values)|2.8||||0.359|TWO_SIDED|95.0|-3.1|8.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||8.7|-3.1|0.359
71670998|NCT03380429|142859801|OTHER||Mean Difference (Final Values)|9.7||||0.004|TWO_SIDED|95.0|3.1|16.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||16.3|3.1|0.004
71670999|NCT03380429|142859801|OTHER||Mean Difference (Final Values)|7.1||||0.032|TWO_SIDED|95.0|0.6|13.5||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||13.5|0.6|0.032
71671000|NCT03380429|142859801|OTHER||Mean Difference (Final Values)|5.9||||0.07|TWO_SIDED|95.0|-0.5|12.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||12.4|-0.5|0.070
71671001|NCT03380429|142859801|OTHER||Mean Difference (Final Values)|3.4||||0.294|TWO_SIDED|95.0|-3.0|9.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.|||9.9|-3.0|0.294
71837172|NCT00450658|143181029|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|8.2||||0.0051|TWO_SIDED|95.0|1.9|14.4|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||||14.4|1.9|0.0051
71671002|NCT03380429|142859802|OTHER||Mean Difference (Final Values)|4.8||||0.118|TWO_SIDED|95.0|-1.2|10.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.8|-1.2|0.118
71671003|NCT03380429|142859802|OTHER||Mean Difference (Final Values)|4.8||||0.105|TWO_SIDED|95.0|-1.0|10.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||10.7|-1.0|0.105
71671004|NCT03380429|142859802|OTHER||Mean Difference (Final Values)|9.2||||0.002|TWO_SIDED|95.0|3.3|15.1||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||15.1|3.3|0.002
71671005|NCT03380429|142859802|OTHER||Mean Difference (Final Values)|7.3||||0.015|TWO_SIDED|95.0|1.5|13.2||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.|||13.2|1.5|0.015
71671006|NCT03380429|142859804|OTHER||Mean Difference (Net)|-0.5||||0.4|TWO_SIDED|95.0|-1.6|0.6||p-value was calculated using Mixed Model Repeated Measures (MMRM).|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||0.6|-1.6|0.400
71671007|NCT03380429|142859804|OTHER||Mean Difference (Net)|0.4||||0.441|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.5|-0.7|0.441
71671008|NCT03380429|142859804|OTHER||Mean Difference (Net)|0.8||||0.164|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.9|-0.3|0.164
71671009|NCT03380429|142859804|OTHER||Mean Difference (Net)|0.3||||0.661|TWO_SIDED|95.0|-0.9|1.4||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.|||1.4|-0.9|0.661
71892101|NCT02863198|143305713|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared|||||||<0.05
71671010|NCT03380429|142859805|OTHER||Odds Ratio (OR)|0.75||||0.385|TWO_SIDED|95.0|0.39|1.44||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.44|0.39|0.385
71671011|NCT03380429|142859805|OTHER||Odds Ratio (OR)|1.24||||0.517|TWO_SIDED|95.0|0.64|2.42||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.42|0.64|0.517
71754989|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.88||||0.0167|TWO_SIDED|95.0|0.79|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Hemorrhagic Stroke / All-Cause Death||0.98|0.79|0.0167
71754990|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.89||||0.0464|TWO_SIDED|95.0|0.8|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Systemic Embolism / All-Cause Death||1.00|0.80|0.0464
71754991|NCT00412984|143012637|OTHER||Hazard Ratio (HR)|0.89||||0.0253|TWO_SIDED|95.0|0.8|0.99||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Myocardial Infarction / All-Cause Death||0.99|0.80|0.0253
71754992|NCT00412984|143012639|OTHER||Hazard Ratio (HR)|0.8||||0.0098|TWO_SIDED|95.0|0.67|0.95||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite Stroke/Systemic Embolism/Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants||0.95|0.67|0.0098
71754993|NCT00412984|143012642|OTHER||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.61|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.61|<.0001
71754994|NCT00412984|143012644|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.68|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.75|0.68|<.0001
71754995|NCT00412984|143012645|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.6||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe GUSTO bleeding events||0.60|0.35|<.0001
71754996|NCT00412984|143012645|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.5|0.71||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe or Moderate GUSTO bleeding events||0.71|0.50|<.0001
71754997|NCT00412984|143012646|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.46|0.7||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Major TIMI bleeding event||0.70|0.46|<.0001
71671012|NCT03380429|142859805|OTHER||Odds Ratio (OR)|0.97||||0.921|TWO_SIDED|95.0|0.51|1.85||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.85|0.51|0.921
71671013|NCT03380429|142859805|OTHER||Odds Ratio (OR)|0.72||||0.321|TWO_SIDED|95.0|0.38|1.38||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.38|0.38|0.321
71671014|NCT03380429|142859806|OTHER||Odds Ratio (OR)|1.04||||0.911|TWO_SIDED|95.0|0.54|1.98||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.98|0.54|0.911
71671015|NCT03380429|142859806|OTHER||Odds Ratio (OR)|1.33||||0.383|TWO_SIDED|95.0|0.7|2.54||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.54|0.70|0.383
71754998|NCT00412984|143012646|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.54|0.75|||Cox Proportional Hazard Model||apixaban / warfarin|Major or Minor TIMI bleeding criteria||0.75|0.54|<.0001
71754999|NCT00412984|143012648|OTHER||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.83||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|||0.83|0.65|<.0001
71755000|NCT04218240|143012650|SUPERIORITY|||||||0.05|||||||Chi-squared|1 degree of freedom||A nonparametric (Kruskal-Wallis) comparison of the two groups (p=0.049)||||.05
71755001|NCT04218240|143012651|OTHER|Chi-square analysis||||||0.27|||||||Chi-squared|||hypothesis: more people in active PGB/LFX will complete withdrawal CI = 95% P = 0.5||||0.27
71755002|NCT01668784|143012669|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0018|TWO_SIDED|98.52|0.57|0.93||The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.|Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.|||0.93|0.57|0.0018
71755003|NCT01668784|143012673|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.034|TWO_SIDED|95.0|0.72|0.99|||Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.|||0.99|0.72|0.0340
71755004|NCT01668784|143012679|SUPERIORITY||Stratified Cox Proportional hazard Model|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Log Rank|||||0.86|0.63|0.0001
71755005|NCT00311766|143012684|SUPERIORITY_OR_OTHER||ANCOVA|0.8|||>|0.05|TWO_SIDED|95.0|||||Fisher Exact|||The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded||||>0.05
71755006|NCT01436526|143012686|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.35||||0.0438||90.0|101.59|115.57|||ANOVA|||||115.57|101.59|0.0438
71892102|NCT00666562|143305728|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
71755007|NCT01436526|143012687|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.19||||0.0514||90.0|101.31|115.54|||ANOVA|||||115.54|101.31|0.0514
71755008|NCT01436526|143012688|NON_INFERIORITY_OR_EQUIVALENCE|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2\*5 mg and 1\*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|111.64||||0.0685||90.0|101.14|123.23|||ANOVA|||||123.23|101.14|0.0685
71755009|NCT03605667|143012694|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.93||0.9809|TWO_SIDED|95.0|-1.8|1.8|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, mini-mental state examination (MMSE) randomization stratification, apolipoprotein E (APoE) status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||1.8|-1.8|0.9809
71671016|NCT03380429|142859806|OTHER||Odds Ratio (OR)|1.08||||0.814|TWO_SIDED|95.0|0.57|2.04||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.04|0.57|0.814
71671017|NCT03380429|142859806|OTHER||Odds Ratio (OR)|1.01||||0.986|TWO_SIDED|95.0|0.53|1.89||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.89|0.53|0.986
71671018|NCT03380429|142859807|OTHER||Odds Ratio (OR)|0.93||||0.833|TWO_SIDED|95.0|0.48|1.81||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.81|0.48|0.833
71671019|NCT03380429|142859807|OTHER||Odds Ratio (OR)|1.35||||0.383|TWO_SIDED|95.0|0.69|2.67||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||2.67|0.69|0.383
71671020|NCT03380429|142859807|OTHER||Odds Ratio (OR)|0.85||||0.628|TWO_SIDED|95.0|0.44|1.63||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.63|0.44|0.628
71671021|NCT03380429|142859807|OTHER||Odds Ratio (OR)|0.94||||0.844|TWO_SIDED|95.0|0.49|1.8||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.|||1.80|0.49|0.844
71787780|NCT02320149|143073309|SUPERIORITY||Treatment Rate Difference|11.05|||<|0.0001|TWO_SIDED|95.0|6.39|15.72||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||15.72|6.39|< 0.0001
71787781|NCT02320149|143073310|SUPERIORITY||Least Squares Mean Difference|-16.7|||<|0.0001|TWO_SIDED|95.0|-21.9|-11.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-11.6|-21.9|< 0.0001
71787782|NCT02320149|143073311|SUPERIORITY||Least Squares Mean Difference|-12.5|||<|0.0001||95.0|-16.9|-8.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-8.0|-16.9|< 0.0001
71671022|NCT01805089|142859808|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71671023|NCT03762265|142859811|SUPERIORITY||Difference in percentage|5.73|STANDARD_ERROR_OF_MEAN|7.535||0.4469|TWO_SIDED|95.0|-9.037|20.5|||Cochran-Mantel-Haenszel|||P-value and 95% confidence interval (CI) were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed greater than \[\>\] 6 months prior to screening\]).||20.500|-9.037|0.4469
71671024|NCT03762265|142859812|SUPERIORITY||Difference in percentage|8.13|STANDARD_ERROR_OF_MEAN|7.085||0.251|TWO_SIDED|95.0|-5.752|22.019|||Cochran-Mantel-Haenszel|||P-value and 95% CI were based on Cochran-Mantel-Haenszel general association test stratified by disease type (PV or PF) and disease history (newly diagnosed \[\<=6 months prior to screening\] or relapsing \[diagnosed \>6 months prior to screening\]).||22.019|-5.752|0.2510
71671025|NCT01383174|142859856|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||0.015
71671026|NCT01383174|142859857|SUPERIORITY_OR_OTHER|||||||0.465|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.465
71787783|NCT02320149|143073312|SUPERIORITY||Least Squares Mean Difference|-13.3|||<|0.0001|TWO_SIDED|95.0|-17.5|-9.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-9.1|-17.5|< 0.0001
71787784|NCT02320149|143073313|SUPERIORITY||Least Squares Mean Difference|-7.2||||0.0003|TWO_SIDED|95.0|-11.1|-3.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-3.3|-11.1|0.0003
71755010|NCT03605667|143012695|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4474|TWO_SIDED|95.0|-0.8|0.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APoE status (carrier/non carrier), as covariates, and repeated measures for visit within participant.||0.3|-0.8|0.4474
71755011|NCT03605667|143012696|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.867|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Model based summary statistics were from an analysis of covariance (ANCOVA) with baseline MMSE total score as covariate.||0.5|-0.6|0.8670
71755012|NCT03605667|143012697|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.21||0.195|TWO_SIDED|95.0|-0.8|3.9|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||3.9|-0.8|0.1950
71755013|NCT03605667|143012698|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.31||0.2583|TWO_SIDED|95.0|-1.1|4.1|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||4.1|-1.1|0.2583
71755014|NCT03605667|143012699|SUPERIORITY|Unstructure covariance structure.|Least square mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4191|TWO_SIDED|95.0|-0.6|1.3|||Mixed model with repeated measures|||Model based summary statistics are from a mixed model with repeated measures, including fixed effects for pooled site ID, treatment, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction, MMSE randomization stratification, APOE status (carrier/non-carrier), as covariates, and repeated measures for visit within participant.||1.3|-0.6|0.4191
71755015|NCT03605667|143012701|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.224|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||Model based summary statistics are from an ANCOVA with baseline MMSE total score as covariate.||0.3|-1.2|0.2240
71755016|NCT03605667|143012702|SUPERIORITY|||||||0.0161|||||||Fisher Exact|||||||0.0161
71671027|NCT01383174|142859858|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.025
71755017|NCT02867436|143012720|SUPERIORITY||Mean Difference (Final Values)|205.0|||<|0.05|TWO_SIDED|95.0|-223.0|633.0|||Regression, Linear|||||633|-223|<0.05
71755018|NCT02867436|143012721|SUPERIORITY||Mean Difference (Final Values)|-7.8|||<|0.05|TWO_SIDED|95.0|-14.1|-1.6|||Regression, Linear|||||-1.6|-14.1|<0.05
71755019|NCT02867436|143012722|SUPERIORITY||Mean Difference (Final Values)|-0.15|||<|0.05|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||||0.01|-0.31|<0.05
71755020|NCT02867436|143012723|SUPERIORITY||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71755021|NCT02867436|143012724|SUPERIORITY||||||<|0.05||||||After Benjamini-Hochberg correction for multiple comparisons|ANOVA|||||||<0.05
71755022|NCT05178173|143012817|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.59
71755023|NCT05178173|143012817|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N1||||0.18
71787785|NCT02320149|143073314|SUPERIORITY||Least Squares Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.3|< 0.0001
71671028|NCT01383174|142859859|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.004
71755024|NCT05178173|143012817|SUPERIORITY|||||||0.78||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.78
71755025|NCT05178173|143012817|SUPERIORITY|||||||0.08||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||SARS CoV-2 N2||||0.08
71755026|NCT00400179|143012829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3952||95.0|||||Fisher Exact|||||||0.3952
71755027|NCT00400179|143012830|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0808|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0808
71755028|NCT00400179|143012831|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.9158|TWO_SIDED|95.0|0.86|1.14|||Log Rank|||||1.14|0.86|0.9158
71755029|NCT00400179|143012832|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.032|TWO_SIDED|95.0|0.77|0.99|||Log Rank|||||0.99|0.77|0.0320
71755030|NCT00400179|143012833|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.1983|TWO_SIDED|95.0|0.8|1.05|||Log Rank|||||1.05|0.80|0.1983
71755031|NCT04272242|143012854|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.91|0.93|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmax, comparing Day 28 to Day 0.||0.93|0.91|
71755032|NCT04272242|143012855|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.96|0.96|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for AUC0-24, comparing Day 28 to Day 0.||0.96|0.96|
71755033|NCT04272242|143012856|EQUIVALENCE|GMRs and associated 90% confidence intervals were calculated to assess the overall effect of 1HP on DTG PK.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||The numerator represents Day 28 and the denominator represents Entry.|Statistical analysis for Cmin, comparing Day 28 to Day 0.||1.00|0.97|
71755034|NCT02711891|143012898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Paired Sample T-test|||||||0.8
71671029|NCT01383174|142859860|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.013
71671030|NCT01383174|142859861|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.267
71671031|NCT01383174|142859862|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.030
71755035|NCT02711891|143012898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Paired Sample T-test|||||||.003
71755036|NCT02711891|143012898|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71755037|NCT02711891|143012900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||t-test, 1 sided|||||||0.01
71755038|NCT02711891|143012900|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|0.05|||||Chi-squared|||||||.001
71755039|NCT02711891|143012902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.876||||||Comparison of mean BPM during lance procedure for L1 vs L2 Loperamide.|t-test, 1 sided|||The population BPM lance one = population BPM mean lance two. Loperamide 1= Loperamide 2. Placebo 1=Placebo 2.||||.876
71755040|NCT02711891|143012902|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085||||||Comparison of the mean between HR one and HR two during the procedure for lance one will equal the mean HR lance two following loperamide gel application.|ANOVA|df 16.||Mean HR during the procedure for lance one will equal mean HR lance two following loperamide gel applciation||||.085
71755041|NCT02677493|143012913|EQUIVALENCE|"All statistical significance testing was performed at a two-sided significance level (α) of 5%.~Exceptionally, non-inferiority was tested at a one-sided CI of 97.5%."||||||0.09135|||||||ANCOVA|||To evaluate if the seroconversion (SCR) and seroprotection (SPR) rates on Day 28 after vaccination of IL-YANG Quadrivalent Influenza Vaccine Inj. meet the following criteria in all age groups of healthy male and female adults at the age of 19 or older.||||0.09135
71787786|NCT02320149|143073315|SUPERIORITY||Least Squares Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.9|-5.4|< 0.0001
71787787|NCT02320149|143073316|SUPERIORITY||Least Squares Mean Difference|-2.1||||0.0005|TWO_SIDED|95.0|-3.3|-0.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-0.9|-3.3|0.0005
71837173|NCT00450658|143181030|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.9||||0.0017|TWO_SIDED|95.0|0.8|7.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||The secondary efficacy endpoint was the proportion of subjects developing duodenal ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative proportion of subjects developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||7.1|0.8|0.0017
71671032|NCT01383174|142859863|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.045
71671033|NCT01383174|142859864|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.005
71671034|NCT01383174|142859865|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED|||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis|||||||.226
71755042|NCT02318706|143012920|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.03||||0.8773|TWO_SIDED|95.0|-0.35|0.3|||Mixed Models Analysis|||Week 14 change from baseline||0.30|-0.35|0.8773
71755043|NCT02318706|143012920|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.15||||0.3494|TWO_SIDED|95.0|-0.48|0.17|||Mixed Models Analysis|||Week 14 change from baseline||0.17|-0.48|0.3494
71755044|NCT02318706|143012920|SUPERIORITY|DS-5565 20 mg and 30 mg are tested against placebo at significance level of 0.025, respectively. If both arms are statistically significant, DS-5565 15 mg arm will be tested at level of 0.05. If neither of the arms is statistically significant, DS-5565 15 mg arm is no longer tested. If either DS-5565 20 mg or DS-5565 30 mg is statistically significant, DS-5565 15 mg arm is tested at level of 0.025.|Hazard Ratio (HR)|-0.5||||0.0027|TWO_SIDED|95.0|-0.82|-0.17|||Mixed Models Analysis|||Week 14 change from baseline||-0.17|-0.82|0.0027
71755045|NCT02798627|143012930|SUPERIORITY||||||=|0.97|||||||Chi-squared|||||||=0.97
71755046|NCT03821402|143012932|SUPERIORITY|||||||0.7645|||||||ANCOVA|||||||0.7645
71755047|NCT03821402|143012932|SUPERIORITY|||||||0.5509|||||||ANCOVA|||||||0.5509
71755048|NCT03821402|143012932|SUPERIORITY|||||||0.0488|||||||ANCOVA|||||||0.0488
71755049|NCT03821402|143012933|SUPERIORITY|||||||0.3698|||||||ANCOVA|||||||0.3698
71755050|NCT03821402|143012933|SUPERIORITY|||||||0.1972|||||||ANCOVA|||||||0.1972
71837174|NCT04410042|143181053|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4|||||||Wilcoxon rank sum test|||||||0.4000
71837175|NCT04410042|143181054|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.4286|||||||Wilcoxon rank sum test|||||||0.4286
71755051|NCT03821402|143012933|SUPERIORITY|||||||0.2037|||||||ANCOVA|||||||0.2037
71755052|NCT03821402|143012938|SUPERIORITY|||||||0.4324|||||||ANCOVA|||||||0.4324
71755053|NCT03821402|143012938|SUPERIORITY|||||||0.3893|||||||ANCOVA|||||||0.3893
71755054|NCT03821402|143012938|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71755055|NCT03821402|143012939|SUPERIORITY|||||||0.0562|||||||ANCOVA|||||||0.0562
71755056|NCT03821402|143012939|SUPERIORITY|||||||0.015|||||||ANCOVA|||||||0.0150
71755057|NCT03821402|143012939|SUPERIORITY|||||||0.0092|||||||ANCOVA|||||||0.0092
71755058|NCT03175367|143012960|SUPERIORITY||Least Squares Mean Difference|-38.5|STANDARD_ERROR_OF_MEAN|9.1|<|0.0001|TWO_SIDED|95.0|-56.5|-20.6|||Mixed Models Analysis|||||-20.6|-56.5|< .0001
71755059|NCT03175367|143012960|SUPERIORITY||Least Squares Mean Difference|-52.9|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-70.7|-35.1|||Mixed Models Analysis|||||-35.1|-70.7|< .0001
71755060|NCT03175367|143012960|SUPERIORITY||Least Squares Mean Difference|-56.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-73.7|-38.3|||Mixed Models Analysis|||||-38.3|-73.7|< .0001
71787788|NCT02320149|143073317|SUPERIORITY||Least Squares Mean Difference|-4.3||||0.5786|TWO_SIDED|95.0|-19.4|10.8||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||10.8|-19.4|0.5786
71755061|NCT03175367|143012960|SUPERIORITY||Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|9.3|=|0.0109|TWO_SIDED|95.0|-42.6|-5.7||P-Value is not adjusted for multiplicity|Mixed Models Analysis|||||-5.7|-42.6|= 0.0109
71787789|NCT02320149|143073318|SUPERIORITY||Least Squares Mean Difference|-2.8||||0.6969|TWO_SIDED|95.0|-17.1|11.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||11.4|-17.1|0.6969
71787790|NCT02320149|143073319|SUPERIORITY||Least Squares Mean Difference|3.0||||0.7377|TWO_SIDED|95.0|-14.7|20.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||20.7|-14.7|0.7377
71787791|NCT02320149|143073320|SUPERIORITY||Least Squares Mean Difference|6.4||||0.2861|TWO_SIDED|95.0|-5.3|18.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||18.1|-5.3|0.2861
71755062|NCT03175367|143012960|SUPERIORITY||Least Squares Mean Difference|-50.5|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|-68.4|-32.6|||Mixed Models Analysis|||||-32.6|-68.4|< .0001
71755063|NCT03175367|143012961|SUPERIORITY||Least Squares Mean Difference|-26.6|STANDARD_ERROR_OF_MEAN|7.2|=|0.0003|TWO_SIDED|95.0|-40.9|-12.4|||Mixed Models Analysis|||||-12.4|-40.9|= 0.0003
71755064|NCT03175367|143012961|SUPERIORITY||Least Squares Mean Difference|-42.0|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-56.1|-27.9|||Mixed Models Analysis|||||-27.9|-56.1|< 0.0001
71755065|NCT03175367|143012961|SUPERIORITY||Least Squares Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|TWO_SIDED|95.0|-59.5|-31.5|||Mixed Models Analysis|||||-31.5|-59.5|< 0.0001
71755066|NCT03175367|143012961|SUPERIORITY||Least Squares Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|6.6|=|0.0132|TWO_SIDED|95.0|-29.7|-3.5|||Mixed Models Analysis|||||-3.5|-29.7|= 0.0132
71755067|NCT03175367|143012961|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED|95.0|-52.0|-26.8|||Mixed Models Analysis|||||-26.8|-52.0|< 0.0001
71755068|NCT03175367|143012962|SUPERIORITY||Least Squares Mean Difference|-21.8|STANDARD_ERROR_OF_MEAN|8.4|=|0.0111|TWO_SIDED|95.0|-38.4|-5.1|||Mixed Models Analysis|||||-5.1|-38.4|= 0.0111
71787792|NCT02320149|143073321|SUPERIORITY||Least Squares Mean Difference|-3.9||||0.0014|TWO_SIDED|95.0|-6.3|-1.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 12||-1.5|-6.3|0.0014
71787793|NCT02320149|143073322|SUPERIORITY||Least Squares Mean Difference|-3.4||||0.001|TWO_SIDED|95.0|-5.5|-1.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-1.4|-5.5|0.0010
71787794|NCT02320149|143073323|SUPERIORITY||Least Squares Mean Difference|-2.0||||0.0371|TWO_SIDED|95.0|-4.0|-0.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-0.1|-4.0|0.0371
71837176|NCT04410042|143181055|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9307|||||||Wilcoxon rank sum test|||||||0.9307
71837177|NCT04410042|143181056|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.0714|||||||Wilcoxon rank sum test|||||||0.0714
71837178|NCT04410042|143181057|EQUIVALENCE|Two-sided test at 0.05 level.||||||0.9004|||||||Wilcoxon rank sum test|||||||0.9004
71755069|NCT03175367|143012962|SUPERIORITY||Least Squares Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|8.2|<|0.0001|TWO_SIDED|95.0|-56.7|-24.0|||Mixed Models Analysis|||||-24.0|-56.7|< 0.0001
71755070|NCT03175367|143012963|SUPERIORITY||Least Squares Mean Difference|-39.3|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-54.4|-24.3|||Mixed Models Analysis|||||-24.3|-54.4|< 0.0001
71755071|NCT03175367|143012963|SUPERIORITY||Least Squares Mean Difference|-53.8|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|95.0|-68.8|-38.9|||Mixed Models Analysis|||||-38.9|-68.8|< 0.0001
71755072|NCT03175367|143012963|SUPERIORITY||Least Squares Mean Difference|-58.5|STANDARD_ERROR_OF_MEAN|7.5|<|0.0001|TWO_SIDED|95.0|-73.4|-43.7|||Mixed Models Analysis|||||-43.7|-73.4|< 0.0001
71755073|NCT03175367|143012963|SUPERIORITY||Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|8.1|=|0.0042|TWO_SIDED|95.0|-39.7|-7.7|||Mixed Models Analysis|||||-7.7|-39.7|= 0.0042
71755074|NCT03175367|143012963|SUPERIORITY||Least Squares Mean Difference|-50.9|STANDARD_ERROR_OF_MEAN|7.8|<|0.0001|TWO_SIDED|95.0|-66.4|-35.4|||Mixed Models Analysis|||||-35.4|-66.4|< 0.0001
71755075|NCT03175367|143012964|SUPERIORITY||Least Squares Mean Difference|-30.6|STANDARD_ERROR_OF_MEAN|9.7|=|0.0021|TWO_SIDED|95.0|-49.8|-11.4|||Mixed Models Analysis|||||-11.4|-49.8|= 0.0021
71837179|NCT01573442|143181070|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||||||0.4952
71837180|NCT01573442|143181071|SUPERIORITY|||||||0.2116|||||||Fisher Exact|||||||0.2116
71837181|NCT01573442|143181072|SUPERIORITY|||||||0.676|||||||Wilcoxon (Mann-Whitney)|||||||0.6760
71755076|NCT03175367|143012964|SUPERIORITY||Least Squares Mean Difference|-54.6|STANDARD_ERROR_OF_MEAN|9.5|<|0.0001|TWO_SIDED|95.0|-73.4|-35.8|||Mixed Models Analysis|||||-35.8|-73.4|< 0.0001
71787795|NCT02320149|143073324|SUPERIORITY||Least Squares Mean Difference|-0.8||||0.3806|TWO_SIDED|95.0|-2.5|1.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||1.0|-2.5|0.3806
71787796|NCT01156311|143073336|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.17|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.17|<0.0001
71787797|NCT01156311|143073336|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.17||||0.0124|TWO_SIDED|95.0|-1.83|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.||-0.33|-1.83|0.0124
71787798|NCT01156311|143073337|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-1.5|-0.25|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||-0.25|-1.50|0.0010
71787799|NCT01156311|143073337|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.0339|TWO_SIDED|95.0|-1.25|0.0|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.||0.00|-1.25|0.0339
71787800|NCT01741701|143073339|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
71755077|NCT03175367|143012965|SUPERIORITY||Odds Ratio, log|19.4|||<|0.0001|TWO_SIDED|95.0|5.1|72.8|||Regression, Logistic|||||72.8|5.1|< 0.0001
71755078|NCT03175367|143012965|SUPERIORITY||Odds Ratio, log|23.9|||<|0.0001|TWO_SIDED|95.0|6.4|89.2|||Regression, Logistic|||||89.2|6.4|< 0.0001
71755079|NCT03175367|143012965|SUPERIORITY||Odds Ratio, log|22.1|||<|0.0001|TWO_SIDED|95.0|6.0|80.5|||Regression, Logistic|||||80.5|6.0|< 0.0001
71755080|NCT03175367|143012965|SUPERIORITY||Odds Ratio, log|8.5|||=|0.0007|TWO_SIDED|95.0|2.5|29.2|||Regression, Logistic|||||29.2|2.5|= 0.0007
71755081|NCT03175367|143012965|SUPERIORITY||Odds Ratio, log|42.3|||<|0.0001|TWO_SIDED|95.0|10.4|172.3|||Regression, Logistic|||||172.3|10.4|< 0.0001
71755082|NCT03175367|143012966|SUPERIORITY||Odds Ratio (OR)|9.6|||=|0.01|TWO_SIDED|95.0|1.7|53.5|||Regression, Logistic|||||53.5|1.7|= 0.0100
71755083|NCT03175367|143012966|SUPERIORITY||Odds Ratio (OR)|24.8|||=|0.0001|TWO_SIDED|95.0|4.7|129.9|||Regression, Logistic|||||129.9|4.7|= 0.0001
71755084|NCT03175367|143012966|SUPERIORITY||Odds Ratio (OR)|36.1|||<|0.0001|TWO_SIDED|95.0|6.7|194.7|||Regression, Logistic|||||194.7|6.7|< 0.0001
71755085|NCT03175367|143012966|SUPERIORITY||Odds Ratio (OR)|2.0|||=|0.3185|TWO_SIDED|95.0|0.5|8.2|||Regression, Logistic|||||8.2|0.5|= 0.3185
71755086|NCT03175367|143012966|SUPERIORITY||Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|3.9|54.2|||Regression, Logistic|||||54.2|3.9|< 0.0001
71755087|NCT03175367|143012967|SUPERIORITY||Odds Ratio (OR)|4.8|||=|0.0718|TWO_SIDED|95.0|0.9|26.5|||Regression, Logistic|||||26.5|0.9|= 0.0718
71787801|NCT01741701|143073340|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of change between groups from baseline to 4 months||||0.51
71787802|NCT01741701|143073341|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||0.97
71755088|NCT03175367|143012967|SUPERIORITY||Odds Ratio (OR)|11.4|||=|0.0048|TWO_SIDED|95.0|2.1|62.1|||Regression, Logistic|||||62.1|2.1|= 0.0048
71755089|NCT03175367|143012967|SUPERIORITY||Odds Ratio (OR)|14.7|||=|0.0015|TWO_SIDED|95.0|2.8|76.8|||Regression, Logistic|||||76.8|2.8|= 0.0015
71787803|NCT01741701|143073342|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months||||.77
71787804|NCT01741701|143073343|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.90
71787805|NCT01741701|143073344|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months||||.95
71755090|NCT03175367|143012967|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.527|TWO_SIDED|95.0|0.3|8.4|||Regression, Logistic|||||8.4|0.3|= 0.5270
71755091|NCT03175367|143012967|SUPERIORITY||Odds Ratio (OR)|7.7|||=|0.0047|TWO_SIDED|95.0|1.9|31.7|||Regression, Logistic|||||31.7|1.9|= 0.0047
71755092|NCT03175367|143012968|SUPERIORITY||Least Squares Mean Difference|-32.5|STANDARD_ERROR_OF_MEAN|11.5|=|0.0059|TWO_SIDED|95.0|-55.5|-9.6|||Mixed Models Analysis|||||-9.6|-55.5|= 0.0059
71755093|NCT03175367|143012968|SUPERIORITY||Least Squares Mean Difference|-54.5|STANDARD_ERROR_OF_MEAN|11.3|<|0.0001|TWO_SIDED|95.0|-77.0|-32.0|||Mixed Models Analysis|||||-32.0|-77.0|< 0.0001
71755094|NCT03175367|143012969|SUPERIORITY||Least Squares Mean Difference|-37.1|STANDARD_ERROR_OF_MEAN|5.7|<|0.0001|TWO_SIDED|95.0|-48.4|-25.8|||Mixed Models Analysis|||||-25.8|-48.4|< .0001
71755095|NCT03175367|143012969|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-57.5|-35.2|||Mixed Models Analysis|||||-35.2|-57.5|< .0001
71755096|NCT03175367|143012969|SUPERIORITY||Least Squares Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|-62.5|-40.4|||Mixed Models Analysis|||||-40.4|-62.5|< .0001
71755097|NCT03175367|143012969|SUPERIORITY||Least Squares Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.2|=|0.0006|TWO_SIDED|95.0|-34.6|-9.8|||Mixed Models Analysis|||||-9.8|-34.6|= 0.0006
71787806|NCT01669915|143073345|SUPERIORITY||Mean Difference (Net)|0.01||||0.31|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.31
71787807|NCT01669915|143073345|SUPERIORITY||Mean Difference (Net)|-0.01||||0.14|TWO_SIDED|95.0|-0.02|0.003|||Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 fatty acids active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.003|-0.02|0.14
71671035|NCT01787292|142859866|SUPERIORITY|||||||0.001||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation||||||.001
71671036|NCT01787292|142859867|SUPERIORITY|||||||0.8|||||||ANCOVA|||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.||||.8
71671037|NCT01787292|142859868|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|||||||.05
71787808|NCT01669915|143073346|SUPERIORITY||Mean Difference (Net)|0.01||||0.49|TWO_SIDED|95.0|-0.01|0.03||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.03|-0.01|0.49
71787809|NCT01669915|143073346|SUPERIORITY||Mean Difference (Net)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.002|-0.04|0.03
71671038|NCT01787292|142859869|SUPERIORITY|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.||||||.05
71787810|NCT01669915|143073347|SUPERIORITY||Mean Difference (Net)|0.01||||0.23|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.02|-0.01|0.23
71787811|NCT01669915|143073347|SUPERIORITY||Mean Difference (Net)|0.003||||0.68|TWO_SIDED|95.0|-0.01|0.02||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization)||0.02|-0.01|0.68
71837182|NCT01573442|143181073|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 1||||0.029
71837183|NCT01573442|143181073|SUPERIORITY|||||||0.8214|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 2||||0.8214
71837184|NCT01573442|143181073|SUPERIORITY|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 3||||0.4952
71671039|NCT01787292|142859870|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71671040|NCT01787292|142859871|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71755098|NCT03175367|143012969|SUPERIORITY||Least Squares Mean Difference|-46.4|STANDARD_ERROR_OF_MEAN|6.1|<|0.0001|TWO_SIDED|95.0|-58.4|-34.4|||Mixed Models Analysis|||||-34.4|-58.4|< .0001
71755099|NCT03175367|143012970|SUPERIORITY||Least Squares Mean Difference|-28.4|STANDARD_ERROR_OF_MEAN|7.1|=|0.0001|TWO_SIDED|95.0|-42.6|-14.3|||Mixed Models Analysis|||||-14.3|-42.6|= 0.0001
71837185|NCT01573442|143181073|SUPERIORITY|||||||0.5232|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 4||||0.5232
71671041|NCT01787292|142859872|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71671042|NCT01787292|142859873|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||.5
71671043|NCT01787292|142859874|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|A Kenward-Rogers adjustment for df was made to account for carryover effects.||||||.6
71671044|NCT01787292|142859875|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||.4
71671045|NCT01787292|142859876|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
71837186|NCT01573442|143181073|SUPERIORITY|||||||0.5522|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 5||||0.5522
71837187|NCT01573442|143181073|SUPERIORITY|||||||0.7005|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 6||||0.7005
71671046|NCT01787292|142859877|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||.25
71837188|NCT01573442|143181077|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
71837189|NCT01573442|143181078|SUPERIORITY|||||||0.8761|||||||Wilcoxon (Mann-Whitney)|||||||0.8761
71671047|NCT01787292|142859878|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71671048|NCT00226499|142859911|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.943|||<|0.0001|TWO_SIDED|97.5|92.446|96.615|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||96.615|92.446|<0.0001
71755100|NCT03175367|143012970|SUPERIORITY||Least Squares Mean Difference|-49.3|STANDARD_ERROR_OF_MEAN|7.0|<|0.0001|TWO_SIDED|95.0|-63.2|-35.4|||Mixed Models Analysis|||||-35.4|-63.2|< .0001
71755101|NCT03175367|143012971|SUPERIORITY||Adjusted Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|6.0|<|0.0001|TWO_SIDED|95.0|-57.8|-34.3|||Regression, Linear|||||-34.3|-57.8|< .0001
71755102|NCT03175367|143012971|SUPERIORITY||Adjusted Mean Difference|-55.8|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-67.3|-44.3|||Regression, Linear|||||-44.3|-67.3|< .0001
71755103|NCT03175367|143012971|SUPERIORITY||Adjusted Mean Difference|-61.5|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|95.0|-72.9|-50.0|||Regression, Linear|||||-50.0|-72.9|< .0001
71755104|NCT03175367|143012971|SUPERIORITY||Adjusted Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|6.5|=|0.0001|TWO_SIDED|95.0|-38.0|-12.4|||Regression, Linear|||||-12.4|-38.0|= 0.0001
71755105|NCT03175367|143012971|SUPERIORITY||Adjusted Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|6.3|<|0.0001|TWO_SIDED|95.0|-58.4|-33.5|||Regression, Linear|||||-33.5|-58.4|< .0001
71755106|NCT03175367|143012972|SUPERIORITY||Adjusted Mean Difference|-17.1|STANDARD_ERROR_OF_MEAN|7.5|=|0.0228|TWO_SIDED|95.0|-31.8|-2.4|||Regression, Linear|||||-2.4|-31.8|= 0.0228
71755107|NCT03175367|143012972|SUPERIORITY||Adjusted Mean Difference|-45.3|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-59.6|-31.0|||Regression, Linear|||||-31.0|-59.6|< .0001
71755108|NCT03175367|143012973|SUPERIORITY||Adjusted Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|5.7|=|0.0635|TWO_SIDED|95.0|-21.8|0.6|||Regression, Linear|||||0.6|-21.8|= 0.0635
71755109|NCT03175367|143012973|SUPERIORITY||Adjusted Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|5.5|=|0.0314|TWO_SIDED|95.0|-22.8|-1.1|||Regression, Linear|||||-1.1|-22.8|= 0.0314
71755110|NCT03175367|143012973|SUPERIORITY||Adjusted Mean Difference|-9.2|STANDARD_ERROR_OF_MEAN|5.5|=|0.0923|TWO_SIDED|95.0|-19.9|1.5|||Regression, Linear|||||1.5|-19.9|= 0.0923
71755111|NCT03175367|143012973|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|5.3|=|0.0017|TWO_SIDED|95.0|-26.8|-6.2|||Regression, Linear|||||-6.2|-26.8|= 0.0017
71755112|NCT03175367|143012973|SUPERIORITY||Adjusted Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|4.9|=|0.0009|TWO_SIDED|95.0|-26.2|-6.8|||Regression, Linear|||||-6.8|-26.2|= 0.0009
71837190|NCT01573442|143181079|SUPERIORITY|||||||0.0176|||||||Wilcoxon (Mann-Whitney)|||||||0.0176
71755113|NCT03175367|143012974|SUPERIORITY||Adjusted Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|5.8|=|0.0054|TWO_SIDED|95.0|-27.4|-4.7|||Regression, Linear|||||-4.7|-27.4|= 0.0054
71755114|NCT03175367|143012974|SUPERIORITY||Adjusted Mean Difference|-14.6|STANDARD_ERROR_OF_MEAN|5.5|=|0.0085|TWO_SIDED|95.0|-25.4|-3.7|||Regression, Linear|||||-3.7|-25.4|= 0.0085
71755115|NCT02151058|143012975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.659|STANDARD_ERROR_OF_MEAN|0.0999|<|0.001|TWO_SIDED|95.0|-0.8559|-0.4622||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4622|-0.8559|<0.001
71755116|NCT02151058|143012975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.993|STANDARD_ERROR_OF_MEAN|0.1005|<|0.001|TWO_SIDED|95.0|-1.1909|-0.7946||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.7946|-1.1909|<0.001
71755117|NCT02151058|143012975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.0812|<|0.001|TWO_SIDED|95.0|-0.4937|-0.1737||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1737|-0.4937|<0.001
71755118|NCT02151058|143012976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.286|STANDARD_ERROR_OF_MEAN|0.0809|<|0.001|TWO_SIDED|95.0|-0.445|-0.1263||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1263|-0.4450|<0.001
71755119|NCT02151058|143012976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.328|STANDARD_ERROR_OF_MEAN|0.0811|<|0.001|TWO_SIDED|95.0|-0.4877|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.4877|<0.001
71755120|NCT02151058|143012976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.0653||0.52|TWO_SIDED|95.0|-0.1709|0.0866||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0866|-0.1709|0.520
71755121|NCT02151058|143012977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.0971|<|0.001|TWO_SIDED|95.0|-0.7043|-0.3217||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3217|-0.7043|<0.001
71837191|NCT01573442|143181080|SUPERIORITY|||||||0.7077|||||||Wilcoxon (Mann-Whitney)|||||||0.7077
71837192|NCT01573442|143181081|SUPERIORITY|||||||0.8748|||||||Wilcoxon (Mann-Whitney)|||||||0.8748
71837193|NCT01573442|143181082|SUPERIORITY|||||||0.4335|||||||Wilcoxon (Mann-Whitney)|||||||0.4335
71837194|NCT01573442|143181083|SUPERIORITY|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||||||0.286
71755122|NCT02151058|143012977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.685|STANDARD_ERROR_OF_MEAN|0.0975|<|0.001|TWO_SIDED|95.0|-0.877|-0.4925||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.4925|-0.8770|<0.001
71755123|NCT02151058|143012977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.0786||0.03|TWO_SIDED|95.0|-0.3268|-0.0168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0168|-0.3268|0.030
71755124|NCT02151058|143012978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0369||0.026|TWO_SIDED|95.0|-0.1556|-0.0102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0102|-0.1556|0.026
71837195|NCT01573442|143181084|SUPERIORITY|||||||0.7694|||||||Wilcoxon (Mann-Whitney)|||||||0.7694
71837196|NCT01573442|143181085|SUPERIORITY|||||||0.9609|||||||Wilcoxon (Mann-Whitney)|||||||0.9609
71671049|NCT00226499|142859911|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|65.428||||0.1265|TWO_SIDED|97.5|57.182|72.086|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||72.086|57.182|0.1265
71755125|NCT02151058|143012978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|STANDARD_ERROR_OF_MEAN|0.0372||0.002|TWO_SIDED|95.0|-0.1917|-0.0451||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0451|-0.1917|0.002
71755126|NCT02151058|143012978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.0297||0.234|TWO_SIDED|95.0|-0.094|0.0231||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0231|-0.0940|0.234
71755127|NCT02151058|143012979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.0568||0.002|TWO_SIDED|95.0|-0.2882|-0.0644||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0644|-0.2882|0.002
71755128|NCT02151058|143012979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_ERROR_OF_MEAN|0.0573|<|0.001|TWO_SIDED|95.0|-0.4638|-0.2378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2378|-0.4638|<0.001
71755129|NCT02151058|143012979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.0458|<|0.001|TWO_SIDED|95.0|-0.2648|-0.0841||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0841|-0.2648|<0.001
71755130|NCT02151058|143012980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.0631|<|0.001|TWO_SIDED|95.0|-0.3713|-0.1226||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||Treatment and baseline value as covariates.||-0.1226|-0.3713|<0.001
71755131|NCT02151058|143012980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.498|STANDARD_ERROR_OF_MEAN|0.0638|<|0.001|TWO_SIDED|95.0|-0.6236|-0.3722||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3722|-0.6236|<0.001
71755132|NCT02151058|143012980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.0511|<|0.001|TWO_SIDED|95.0|-0.3516|-0.1503||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1503|-0.3516|<0.001
71755133|NCT02151058|143012981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0372||0.001|TWO_SIDED|95.0|-0.197|-0.0504||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0504|-0.1970|0.001
71755134|NCT02151058|143012981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.0373|<|0.001|TWO_SIDED|95.0|-0.2413|-0.0941||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0941|-0.2413|<0.001
71755135|NCT02151058|143012981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.0301||0.145|TWO_SIDED|95.0|-0.1034|0.0152||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.0152|-0.1034|0.145
71755136|NCT02151058|143012982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.0497|<|0.001|TWO_SIDED|95.0|-0.3282|-0.1321||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1321|-0.3282|<0.001
71787812|NCT01669915|143073348|SUPERIORITY||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.04|0.09||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in vitamin D active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||0.09|-0.04|0.46
71787813|NCT01669915|143073348|SUPERIORITY||Mean Difference (Net)|-0.1||||0.003|TWO_SIDED|95.0|-0.17|-0.04||Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167).|Mixed Models Analysis|||The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization).||-0.04|-0.17|0.003
71787814|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-3.48|7.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.||7.70|-3.48|
71787815|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|5.33|||||TWO_SIDED|95.0|-0.41|11.07||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.||11.07|-0.41|
71787816|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|2.49|||||TWO_SIDED|95.0|-3.35|8.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.||8.33|-3.35|
71755137|NCT02151058|143012982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4113|-0.2141||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.2141|-0.4113|<0.001
71671050|NCT00226499|142859912|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.498||||0.0001|TWO_SIDED|95.0|97.522|99.898|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.898|97.522|0.0001
71755138|NCT02151058|143012982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|STANDARD_ERROR_OF_MEAN|0.0404||0.042|TWO_SIDED|95.0|-0.1621|-0.0031||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.0031|-0.1621|0.042
71787817|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-6.11|5.36||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.||5.36|-6.11|
71787818|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|4.36|||||TWO_SIDED|95.0|-1.57|10.29||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.||10.29|-1.57|
71787819|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|4.6|||||TWO_SIDED|95.0|-1.45|10.65||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.||10.65|-1.45|
71787820|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|-4.25|||||TWO_SIDED|95.0|-10.44|1.93||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.||1.93|-10.44|
71787821|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|-0.45|||||TWO_SIDED|95.0|-7.22|6.32||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.||6.32|-7.22|
71787822|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|-1.46|||||TWO_SIDED|95.0|-8.25|5.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.||5.33|-8.25|
71671051|NCT00226499|142859912|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|90.741||||0.1265|TWO_SIDED|95.0|85.866|93.934|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||93.934|85.866|0.1265
71671052|NCT00226499|142859913|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|92.487|||<|0.0001|TWO_SIDED|95.0|89.927|94.396|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||94.396|89.927|<0.0001
71671053|NCT00226499|142859913|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|64.585||||0.1265|TWO_SIDED|95.0|57.503|70.486|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||70.486|57.503|0.1265
71755139|NCT02151058|143012983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.275|STANDARD_ERROR_OF_MEAN|0.0543|<|0.001|TWO_SIDED|95.0|-0.382|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1679|-0.3820|<0.001
71755140|NCT02151058|143012983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_ERROR_OF_MEAN|0.0548|<|0.001|TWO_SIDED|95.0|-0.5724|-0.3565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.3565|-0.5724|<0.001
71755141|NCT02151058|143012983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.0442|<|0.001|TWO_SIDED|95.0|-0.2767|-0.1023||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.1023|-0.2767|<0.001
71787823|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-5.98|6.29||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.||6.29|-5.98|
71787824|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|8.3|||||TWO_SIDED|95.0|1.52|15.08||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.||15.08|1.52|
71787825|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|3.82|||||TWO_SIDED|95.0|-2.85|10.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.||10.50|-2.85|
71787826|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-7.16|4.97||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.||4.97|-7.16|
71787827|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|6.78|||||TWO_SIDED|95.0|-0.11|13.66||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.||13.66|-0.11|
71787828|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|3.29|||||TWO_SIDED|95.0|-3.58|10.15||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.||10.15|-3.58|
71787829|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-7.64|5.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.||5.40|-7.64|
71787830|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|3.59|||||TWO_SIDED|95.0|-3.71|10.89||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.||10.89|-3.71|
71787831|NCT00372112|143073351|SUPERIORITY||Mean Difference (Net)|2.11|||||TWO_SIDED|95.0|-4.96|9.18||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.||9.18|-4.96|
71787832|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|2.1|||||TWO_SIDED|95.0|-7.7|12.0||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.||12.0|-7.7|
71755142|NCT03181932|143012988|SUPERIORITY|The primary efficacy endpoint was tested sequentially at Week 4 (end of Cycle 1), Week 12 (end of Cycle 2) and at Week 20 (end of Cycle 3). If a statistically significant difference was observed in favor of vancomycin inhalation powder compared to placebo after Cycle 1, then the mean change in the FEV1 percent predicted during Cycle 2 was to be tested. Similarly, if the effect after Cycle 2 was statistically significant, then the analysis of Baseline to end of Cycle 3 was to be tested.|Least square mean difference|1.4||||0.325|TWO_SIDED|95.0|-1.4|4.1|||Mixed Models Analysis|||Based on previous experience, a sample size of 45 participants per arm would provide 89% power to detect a statistically significant difference at alpha level of 0.05. To account for potential dropouts and/or smaller effect size in a 3-cycle trial, a sample size of 75 participants per arm was to be enrolled in the primary analysis population, which if all completed would provide 90% power to detect a difference of 3.4% at 20 weeks assuming the same standard deviation of 6.3%.||4.1|-1.4|0.325
71755143|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0187|=|0.02|TWO_SIDED|90.0|0.008|0.069|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour||0.069|0.008|=0.020
71755144|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.0227|<|0.001|TWO_SIDED|90.0|0.101|0.176|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.176|0.101|<0.001
71755145|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0217|<|0.001|TWO_SIDED|90.0|0.087|0.158|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.158|0.087|<0.001
71755146|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0185|=|0.22|TWO_SIDED|90.0|-0.016|0.045|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.045|-0.016|=0.220
71755147|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|90.0|0.087|0.161|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.161|0.087|<0.001
71755148|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.0214|<|0.001|TWO_SIDED|90.0|0.105|0.176|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.176|0.105|<0.001
71755149|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.0188||0.155|TWO_SIDED|90.0|-0.012|0.05|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.050|-0.012|0.155
71755150|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.0229|<|0.001|TWO_SIDED|90.0|0.053|0.129|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour||0.129|0.053|<0.001
71755151|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|90.0|0.09|0.162|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.162|0.090|<0.001
71671054|NCT00226499|142859933|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|95.855|||<|0.0001|TWO_SIDED|95.0|94.075|97.101|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||97.101|94.075|<0.0001
71755152|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.188|TWO_SIDED|90.0|-0.015|0.048|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.048|-0.015|0.188
71755153|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.023|=|0.009|TWO_SIDED|90.0|0.017|0.093|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.093|0.017|=0.009
71755154|NCT00674817|143013004|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|90.0|0.086|0.159|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.159|0.086|<0.001
71755155|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.0616|=|0.856|TWO_SIDED|90.0|-0.168|0.036|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour||0.036|-0.168|=0.856
71755156|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.0496|=|0.033|TWO_SIDED|90.0|0.01|0.174|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour||0.174|0.010|=0.033
71755157|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.0523|=|0.099|TWO_SIDED|90.0|-0.019|0.154|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour||0.154|-0.019|=0.099
71755158|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.067|STANDARD_ERROR_OF_MEAN|0.0612|=|0.862|TWO_SIDED|90.0|-0.168|0.034|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour||0.034|-0.168|=0.862
71755159|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.0493|=|0.008|TWO_SIDED|90.0|0.039|0.201|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour||0.201|0.039|=0.008
71755160|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0516||0.027|TWO_SIDED|90.0|0.015|0.185|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour||0.185|0.015|0.027
71755161|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.0621|=|0.2|TWO_SIDED|90.0|-0.05|0.155|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour||0.155|-0.050|=0.200
71787833|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-7.2|13.1||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.||13.1|-7.2|
71787834|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-10.2|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.||10.1|-10.2|
71787835|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|2.2|||||TWO_SIDED|95.0|-6.1|10.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.||10.4|-6.1|
71671055|NCT00226499|142859933|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|69.812||||0.1265|TWO_SIDED|95.0|62.848|75.47|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.||75.470|62.848|0.1265
71787836|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|5.8|||||TWO_SIDED|95.0|-2.8|14.3||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.||14.3|-2.8|
71787837|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-6.9|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.||10.1|-6.9|
71755162|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.05|=|0.031|TWO_SIDED|90.0|0.011|0.177|||Mix model|||GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour||0.177|0.011|=0.031
71787838|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|-4.9|||||TWO_SIDED|95.0|-16.1|6.2||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.||6.2|-16.1|
71787839|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-14.0|10.2||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.||10.2|-14.0|
71787840|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|-4.8|||||TWO_SIDED|95.0|-17.1|7.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.||7.5|-17.1|
71755163|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.053|=|0.043|TWO_SIDED|90.0|0.004|0.179|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour||0.179|0.004|=0.043
71755164|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.0625|=|0.637|TWO_SIDED|90.0|-0.125|0.081|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour||0.081|-0.125|=0.637
71755165|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.05|=|0.004|TWO_SIDED|90.0|0.053|0.218|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour||0.218|0.053|=0.004
71755166|NCT00674817|143013005|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.0534|=|0.031|TWO_SIDED|90.0|0.012|0.189|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour||0.189|0.012|=0.031
71755167|NCT00674817|143013011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.747|STANDARD_ERROR_OF_MEAN|2.1768|||TWO_SIDED|95.0|-0.547|8.041||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||8.041|-0.547|
71755168|NCT00674817|143013011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.712|STANDARD_ERROR_OF_MEAN|2.1453|||TWO_SIDED|95.0|-2.521|5.944||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours||5.944|-2.521|
71755169|NCT00674817|143013011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.755|STANDARD_ERROR_OF_MEAN|2.1869|||TWO_SIDED|95.0|-2.559|6.069||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours||6.069|-2.559|
71755170|NCT00674817|143013011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.231|STANDARD_ERROR_OF_MEAN|2.197|||TWO_SIDED|95.0|-5.565|3.103||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||3.103|-5.565|
71787841|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|-4.1|10.9||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.||10.9|-4.1|
71787842|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|2.6|19.0||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.||19.0|2.6|
71787843|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|3.1|||||TWO_SIDED|95.0|-5.2|11.4||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.||11.4|-5.2|
71787844|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-17.0|2.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.||2.7|-17.0|
71787845|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|5.4|||||TWO_SIDED|95.0|-6.0|16.8||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.||16.8|-6.0|
71787846|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-13.8|8.0||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.||8.0|-13.8|
71787847|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-7.8|8.3||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.||8.3|-7.8|
71787848|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|6.8|||||TWO_SIDED|95.0|-2.1|15.6||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.||15.6|-2.1|
71787849|NCT00372112|143073353|SUPERIORITY||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-4.5|13.3||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.||13.3|-4.5|
71787850|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.1131|||||TWO_SIDED|95.0|-0.0031|0.2293|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2293|-0.0031|
71755171|NCT00674817|143013012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.558|STANDARD_ERROR_OF_MEAN|2.7064|||TWO_SIDED|95.0|-0.781|9.897||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours||9.897|-0.781|
71755172|NCT00674817|143013012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.266|STANDARD_ERROR_OF_MEAN|2.6691|||TWO_SIDED|95.0|-2.999|7.532||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours||7.532|-2.999|
71787851|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.159|||||TWO_SIDED|95.0|0.0408|0.2771|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.||0.2771|0.0408|
71787852|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.0764|||||TWO_SIDED|95.0|-0.0375|0.1903|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.||0.1903|-0.0375|
71787853|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.1741|||||TWO_SIDED|95.0|0.0178|0.3305|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3305|0.0178|
71671056|NCT00226499|142859934|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.072|||<|0.0001|TWO_SIDED|95.0|97.907|99.589|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||99.589|97.907|<0.0001
71671057|NCT00226499|142859934|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|89.532||||0.1265|TWO_SIDED|95.0|86.126|92.102|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.||92.102|86.126|0.1265
71671058|NCT00226499|142859935|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.816|||<|0.0001|TWO_SIDED|95.0|92.838|96.248|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||96.248|92.838|<0.0001
71671059|NCT00226499|142859935|OTHER|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|68.932||||0.1265|TWO_SIDED|95.0|61.893|74.671|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.||74.671|61.893|0.1265
71671060|NCT00946920|142859954|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between treatments (degarelix versus goserelin acetate) was chosen to be -5 percentage points.|Kaplan-Meier estimate|79.6|||||TWO_SIDED|95.0|75.6|83.7||||||The cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364 was estimated by the Kaplan-Meier method. Only testosterone measurements taken at scheduled trial visits from Day 3 to Day 364 were included in the analysis. The hypothesis to test was the following: a non-inferiority assessment determined whether degarelix was non-inferior to goserelin with respect to the cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364.||83.7|75.6|
71671061|NCT04616612|142859959|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||.04
71671062|NCT04616612|142859960|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||.04
71671063|NCT04616612|142859961|OTHER||||||||||||||||||"Qualitative data evaluated from interviews tailored after the acceptability scale questionnaire. These interview questions specifically asked participant to rate from strongly disagree to strongly agree on each question and then rationalize answers.~Mobile support: 77% of participants agreed that mobile messages supported their health behaviors.~Time required: 85% disagreed that the intervention took too much time to learn.~Program effectiveness: 92% enjoyed this learning approach, with 100% agreeing they could use the information to improve health behaviors.~Rationalization feedback found participants in rural areas reported difficulties accessing texts."|||
71787854|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.1713|||||TWO_SIDED|95.0|0.006|0.3365|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.||0.3365|0.0060|
71787855|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.1377|||||TWO_SIDED|95.0|-0.0233|0.2987|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.||0.2987|-0.0233|
71787856|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.0266|0.3046|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3046|-0.0266|
71837197|NCT03649659|143181086|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|99.9|2.54|6.48|||Regression, Logistic|Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.||||6.48|2.54|<0.0001
71671064|NCT04616612|142859962|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71787857|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.1906|||||TWO_SIDED|95.0|0.0177|0.3635|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.||0.3635|0.0177|
71787858|NCT00372112|143073368|SUPERIORITY||Mean Difference (Net)|0.0956|||||TWO_SIDED|95.0|-0.0686|0.2599|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline FEV1, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.||0.2599|-0.0686|
71787859|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.009|||||TWO_SIDED|95.0|-0.59|0.608|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.608|-0.590|
71837198|NCT03649659|143181087|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.0001|TWO_SIDED|99.9|2.84|8.05||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||8.05|2.84|<0.0001
71671065|NCT04616612|142859963|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71671066|NCT04616612|142859964|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
71671067|NCT04616612|142859965|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||||||0.66
71671068|NCT04616612|142859966|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||.84
71671069|NCT04616612|142859967|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||||||0.84
71671070|NCT01597973|142859968|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
71671071|NCT01597973|142859969|SUPERIORITY|||||||0.583|||||||Chi-squared|||||||0.5830
71671072|NCT01597973|142859970|SUPERIORITY|||||||0.07|||||||Chi-squared|||||||0.07
71671073|NCT01597973|142859971|SUPERIORITY|||||||0.255|||||||Chi-squared|||||||0.255
71671074|NCT01597973|142859972|SUPERIORITY|||||||0.59|||||||Chi-squared|||nephrotoxicity analysis||||0.59
71671075|NCT01597973|142859972|SUPERIORITY|||||||0.22|||||||Fisher Exact|||Hypersensitivity analysis||||0.22
71787860|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.237|||||TWO_SIDED|95.0|-0.354|0.829|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.||0.829|-0.354|
71787861|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.093|||||TWO_SIDED|95.0|-0.469|0.654|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.||0.654|-0.469|
71787862|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.199|||||TWO_SIDED|95.0|-0.591|0.988|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.||0.988|-0.591|
71787863|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.633|||||TWO_SIDED|95.0|-0.152|1.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.||1.418|-0.152|
71787864|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.065|||||TWO_SIDED|95.0|-0.667|0.797|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.||0.797|-0.667|
71787865|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.097|||||TWO_SIDED|95.0|-0.476|0.67|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.||0.670|-0.476|
71787866|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.408|||||TWO_SIDED|95.0|-0.208|1.024|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.||1.024|-0.208|
71787867|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.471|0.631|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.||0.631|-0.471|
71787868|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.245|||||TWO_SIDED|95.0|-0.66|1.149|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.149|-0.660|
71787869|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.796|||||TWO_SIDED|95.0|-0.174|1.766|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.||1.766|-0.174|
71787870|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.144|||||TWO_SIDED|95.0|-0.742|1.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.||1.030|-0.742|
71787871|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.056|||||TWO_SIDED|95.0|-0.556|0.669|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.669|-0.556|
71787872|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.138|||||TWO_SIDED|95.0|-0.767|0.491|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.||0.491|-0.767|
71787873|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.187|||||TWO_SIDED|95.0|-0.765|0.391|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.||0.391|-0.765|
71787874|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.094|||||TWO_SIDED|95.0|-0.619|0.806|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.||0.806|-0.619|
71787875|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.358|||||TWO_SIDED|95.0|-0.39|1.105|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.||1.105|-0.390|
71787876|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.178|||||TWO_SIDED|95.0|-0.522|0.877|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.||0.877|-0.522|
71837199|NCT03649659|143181088|SUPERIORITY||Odds Ratio (OR)|5.84|||<|0.0001|TWO_SIDED|99.9|3.59|9.51||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||9.51|3.59|<0.0001
71837200|NCT03649659|143181089|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8942|TWO_SIDED|99.9|0.25|3.54||Multiple imputation (25) of missing data, FCS methods. Group comparisons using GEE logistic model, exchangeable correlation, study site as covariate.|Regression, Logistic|||||3.54|0.25|0.8942
71837201|NCT01963793|143181116|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.58|TWO_SIDED|95.0|-7.12|4.11|||t-test, 2 sided|||||4.11|-7.12|0.58
71671076|NCT01597973|142859972|SUPERIORITY|||||||0.94|||||||Chi-squared|||Hepatoxicity analysis||||0.94
71671077|NCT01597973|142859972|SUPERIORITY|||||||1|||||||Fisher Exact|||Seizures analysis||||1.00
71671078|NCT01597973|142859972|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Neurotoxicity analysis||||0.20
71787877|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.294|||||TWO_SIDED|95.0|-0.586|-0.001|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.001|-0.586|
71787878|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.371|||||TWO_SIDED|95.0|-0.657|-0.085|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.||-0.085|-0.657|
71671079|NCT00503698|142859995|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.91|TWO_SIDED|95.0|0.6|1.57|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.57|0.60|0.91
71671080|NCT00503698|142859996|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.4977|TWO_SIDED|95.0|0.6|1.28|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates||||1.28|0.60|0.4977
71671081|NCT00503698|142859997|SUPERIORITY_OR_OTHER||Rate ratio|1.13||||0.4409|TWO_SIDED|95.0|0.83|1.53|||Negative binomial regression|||||1.53|0.83|0.4409
71671082|NCT02259010|142860014|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.82|1.19|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.19|0.82|
71671083|NCT02259010|142860015|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.35|||||TWO_SIDED|90.0|1.02|1.79|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.79|1.02|
71671084|NCT02259010|142860016|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Ratio|1.39|||||TWO_SIDED|90.0|0.99|1.95|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.|||1.95|0.99|
71671085|NCT03830333|142860027|NON_INFERIORITY|Ceftolozane/tazobactam + metronidazole is concluded to be non-inferior to meropenem + placebo if the lower bound of the 95% CI for the treatment difference in percent response is above -12.5 percentage points.|Difference in percentages|2.1|||||TWO_SIDED|95.0|-4.7|8.8||||||Difference in percentage was based on Miettinen and Nurminen method with the Cochran-Mantel-Haenszel (CMH) weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||8.8|-4.7|
71671086|NCT03830333|142860028|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-12.6|3.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||3.7|-12.6|
71671087|NCT03830333|142860029|OTHER||Difference in percentages|1.4|||||TWO_SIDED|95.0|-3.8|6.7||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||6.7|-3.8|
71787879|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.153|||||TWO_SIDED|95.0|-0.44|0.133|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.||0.133|-0.440|
71671088|NCT03830333|142860030|OTHER||Difference in percentages|-1.5|||||TWO_SIDED|95.0|-8.0|4.8||||||Difference in percentage was based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||4.8|-8.0|
71671089|NCT03830333|142860031|OTHER||Difference in percentages|1.2|||||TWO_SIDED|95.0|-9.2|10.4||||||Difference in percentage based on Miettinen and Nurminen method with the CMH weighting stratified by anatomic site of infection (bowel \[small or large\] versus other site of cIAI).||10.4|-9.2|
71671090|NCT03830333|142860032|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.0|||||TWO_SIDED|95.0|-11.9|8.7||||||Gram-negative aerobes comparison: Based on unstratified Miettinen and Nurminen method.||8.7|-11.9|
71671091|NCT03830333|142860032|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-12.5|8.5||||||All enterobacteriaceae comparison: Based on unstratified Miettinen and Nurminen method.||8.5|-12.5|
71671092|NCT03830333|142860032|OTHER|Difference in percentage was based on unstratified Miettinen and Nurminen method. Confidence Interval is displayed only when there are at least 4 participants in at least one treatment group.|Difference in percentages|-8.2|||||TWO_SIDED|95.0|-42.2|20.0||||||Gram-positive aerobes comparison: Based on unstratified Miettinen and Nurminen method.||20.0|-42.2|
71671093|NCT03830333|142860033|OTHER||Difference in Percentages|-0.7|||||TWO_SIDED|95.0|-12.6|11.2||||||Difference in percentage was based on Miettinen \& Nurminen method.||11.2|-12.6|
71671094|NCT03830333|142860034|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-4.4|4.4||||||Difference in percentage was based on Miettinen \& Nurminen method.||4.4|-4.4|
71671095|NCT02996227|142860057|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Mean Difference (Final Values)|0.09|||<|0.001|TWO_SIDED|95.2|-0.12|0.3|||Mixed Models Analysis|||||0.30|-0.12|<0.001
71671096|NCT02996227|142860058|NON_INFERIORITY|The noninferiority was defined as no more than 25% greater opioid consumption and no worse than 1-point higher pain score at rest. Non-inferiority of TAP with liposomal bupivacaine to epidural could be claimed if the upper limit of the 95.2% CI for the mean difference of pain scores at rest was less than 1 point and the CI for the ratio of geometric means in opioid consumption was less than 1.25.|Ratio of Geometric means|1.37||||0.754|TWO_SIDED|95.2|1.05|1.79|||Mixed Models Analysis|||||1.79|1.05|0.754
71671097|NCT02996227|142860059|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.56|TWO_SIDED|99.0|0.53|2.76|||Regression, Linear|linear regression after logarithm transformation||||2.76|0.53|0.560
71787880|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.216|||||TWO_SIDED|95.0|-0.679|0.247|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.||0.247|-0.679|
71787881|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.536|||||TWO_SIDED|95.0|-0.998|-0.074|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.||-0.074|-0.998|
71755173|NCT00674817|143013012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.717|||TWO_SIDED|95.0|-4.429|6.29||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours||6.290|-4.429|
71755174|NCT00674817|143013012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.152|STANDARD_ERROR_OF_MEAN|2.731|||TWO_SIDED|95.0|-6.539|4.236||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours||4.236|-6.539|
71755175|NCT00674817|143013013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.249|STANDARD_ERROR_OF_MEAN|1.6816|||TWO_SIDED|95.0|-2.069|4.566||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||4.566|-2.069|
71787882|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.018|||||TWO_SIDED|95.0|-0.452|0.416|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.||0.416|-0.452|
71755176|NCT00674817|143013013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.418|STANDARD_ERROR_OF_MEAN|1.6565|||TWO_SIDED|95.0|-2.85|3.687||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours||3.687|-2.850|
71787883|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.486|||||TWO_SIDED|95.0|-0.878|-0.095|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.095|-0.878|
71671098|NCT02996227|142860060|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.357|TWO_SIDED|99.0|-0.65|1.37|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure|||1.37|-0.65|0.357
71671099|NCT02996227|142860061|SUPERIORITY||Risk Ratio (RR)|0.64||||0.006|TWO_SIDED|99.0|0.42|0.98|||generalized linear regression|||||0.98|0.42|0.006
71755177|NCT00674817|143013013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-4.013|2.714||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||2.714|-4.013|
71787884|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.562|||||TWO_SIDED|95.0|-0.99|-0.135|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.||-0.135|-0.990|
71787885|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.575|0.196|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.||0.196|-0.575|
71787886|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.075|||||TWO_SIDED|95.0|-0.235|0.385|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.385|-0.235|
71787887|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.275|||||TWO_SIDED|95.0|-0.623|0.073|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.||0.073|-0.623|
71845569|NCT00357994|143205624|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0361|TWO_SIDED|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||-0.1|-2.4|0.0361
71845570|NCT00357994|143205625|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3578|TWO_SIDED|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||0.4|-1.1|0.3578
71755178|NCT00674817|143013013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.949|STANDARD_ERROR_OF_MEAN|1.7112|||TWO_SIDED|95.0|-5.325|1.427||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours||1.427|-5.325|
71845571|NCT00357994|143205626|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|-1.5|STANDARD_ERROR_OF_MEAN|2.9||0.6088|TWO_SIDED|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||4.4|-7.4|0.6088
71755179|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.198|STANDARD_ERROR_OF_MEAN|2.5039|||TWO_SIDED|95.0|5.258|15.139||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||15.139|5.258|
71755180|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.686|STANDARD_ERROR_OF_MEAN|2.4738|||TWO_SIDED|95.0|-2.195|7.567||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||7.567|-2.195|
71755181|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.854|STANDARD_ERROR_OF_MEAN|2.5196|||TWO_SIDED|95.0|2.883|12.825||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||12.825|2.883|
71787888|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.103|||||TWO_SIDED|95.0|-0.213|0.418|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.||0.418|-0.213|
71671100|NCT02996227|142860062|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.695|TWO_SIDED|99.0|-4.31|5.85|||Regression, Linear||Difference in means between two groups was assessed using mixed effects model with repeated measurements with unstructured correlation structure.|||5.85|-4.31|0.695
71755182|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|2.5244|||TWO_SIDED|95.0|-5.864|4.097||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||4.097|-5.864|
71755183|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.227|STANDARD_ERROR_OF_MEAN|2.9782|||TWO_SIDED|95.0|5.352|17.103||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||17.103|5.352|
71755184|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|2.9434|||TWO_SIDED|95.0|-1.418|10.197||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||10.197|-1.418|
71755185|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.975|STANDARD_ERROR_OF_MEAN|2.9958|||TWO_SIDED|95.0|0.065|11.886||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||11.886|0.065|
71755186|NCT00674817|143013014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.083|STANDARD_ERROR_OF_MEAN|3.0023|||TWO_SIDED|95.0|-8.006|3.84||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||3.840|-8.006|
71755187|NCT00674817|143013015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|1.6941|||TWO_SIDED|95.0|1.857|8.542||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||8.542|1.857|
71755188|NCT00674817|143013015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|1.6727|||TWO_SIDED|95.0|-3.294|3.307||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.307|-3.294|
71755189|NCT00674817|143013015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.956|STANDARD_ERROR_OF_MEAN|1.7178|||TWO_SIDED|95.0|-0.433|6.345||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||6.345|-0.433|
71755190|NCT00674817|143013015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.683|STANDARD_ERROR_OF_MEAN|1.7199|||TWO_SIDED|95.0|-5.076|1.711||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.711|-5.076|
71755191|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.588|STANDARD_ERROR_OF_MEAN|1.3932|||TWO_SIDED|95.0|3.839|9.336||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||9.336|3.839|
71755192|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.255|STANDARD_ERROR_OF_MEAN|1.3725|||TWO_SIDED|95.0|-1.453|3.962||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||3.962|-1.453|
71755193|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.985|STANDARD_ERROR_OF_MEAN|1.396|||TWO_SIDED|95.0|4.231|9.738||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||9.738|4.231|
71787889|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.299|||||TWO_SIDED|95.0|-0.64|0.042|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.042|-0.640|
71755194|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.255|STANDARD_ERROR_OF_MEAN|1.4077|||TWO_SIDED|95.0|-0.522|5.031||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.031|-0.522|
71755195|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.121|STANDARD_ERROR_OF_MEAN|1.2464|||TWO_SIDED|95.0|1.662|6.58||||||GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours||6.580|1.662|
71787890|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.271|||||TWO_SIDED|95.0|-0.621|0.079|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.||0.079|-0.621|
71845572|NCT00357994|143205627|SUPERIORITY_OR_OTHER||Treatment Difference (LS Mean)|11.4|STANDARD_ERROR_OF_MEAN|3.7||0.0033|TWO_SIDED|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||||18.9|4.0|0.0033
71671101|NCT02996227|142860063|SUPERIORITY||Ratio of geometric means|0.98||||0.738|TWO_SIDED|99.0|0.86|1.12|||Regression, Linear|linear regression after logarithmic transformation||||1.12|0.86|0.738
71671102|NCT04242446|142860070|SUPERIORITY||Odds Ratio (OR)|2.0||||0.03|TWO_SIDED|97.5|0.979|4.089|||Regression, Logistic|||||4.089|0.979|0.030
71755196|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|1.2278|||TWO_SIDED|95.0|-2.142|2.703||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.703|-2.142|
71755197|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.266|STANDARD_ERROR_OF_MEAN|1.249|||TWO_SIDED|95.0|1.802|6.729||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||6.729|1.802|
71755198|NCT00674817|143013016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.621|STANDARD_ERROR_OF_MEAN|1.2593|||TWO_SIDED|95.0|-0.863|4.106||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||4.106|-0.863|
71755199|NCT00674817|143013017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.094|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|2.456|5.732||||||GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||5.732|2.456|
71755200|NCT00674817|143013017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.646|STANDARD_ERROR_OF_MEAN|0.8172|||TWO_SIDED|95.0|-0.967|2.258||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||2.258|-0.967|
71755201|NCT00674817|143013017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.98|STANDARD_ERROR_OF_MEAN|0.8395|||TWO_SIDED|95.0|2.324|5.636||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||5.636|2.324|
71755202|NCT00674817|143013017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.934|STANDARD_ERROR_OF_MEAN|0.846|||TWO_SIDED|95.0|-0.735|2.603||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||2.603|-0.735|
71787891|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.095|||||TWO_SIDED|95.0|-0.432|0.243|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.||0.243|-0.432|
71845573|NCT03244800|143205630|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71755203|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.836|STANDARD_ERROR_OF_MEAN|1.8168|||TWO_SIDED|95.0|-5.42|1.748||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.748|-5.420|
71755204|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.599|STANDARD_ERROR_OF_MEAN|1.7809|||TWO_SIDED|95.0|-2.914|4.113||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.113|-2.914|
71755205|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|1.8174|||TWO_SIDED|95.0|-3.261|3.909||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||3.909|-3.261|
71755206|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.182|STANDARD_ERROR_OF_MEAN|1.8242|||TWO_SIDED|95.0|-5.781|1.416||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.416|-5.781|
71755207|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.266|STANDARD_ERROR_OF_MEAN|1.7723|||TWO_SIDED|95.0|-6.762|0.23||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.230|-6.762|
71755208|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|1.7361|||TWO_SIDED|95.0|-3.502|3.348||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||3.348|-3.502|
71755209|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.827|STANDARD_ERROR_OF_MEAN|1.7743|||TWO_SIDED|95.0|-1.673|5.327||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||5.327|-1.673|
71787892|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.173|||||TWO_SIDED|95.0|-0.158|0.505|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.505|-0.158|
71671103|NCT04242446|142860070|SUPERIORITY||Odds Ratio (OR)|2.234||||0.006|TWO_SIDED|97.5|1.159|4.307|||Regression, Logistic|||||4.307|1.159|0.006
71671104|NCT04242446|142860071|SUPERIORITY||Odds Ratio (OR)|1.416||||0.35|TWO_SIDED|97.5|0.615|3.26||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||3.260|0.615|0.350
71755210|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.232|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-4.743|2.279||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.279|-4.743|
71755211|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.394|STANDARD_ERROR_OF_MEAN|1.3084|||TWO_SIDED|95.0|-3.976|1.187||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||1.187|-3.976|
71755212|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.181|STANDARD_ERROR_OF_MEAN|1.2819|||TWO_SIDED|95.0|-1.348|3.71||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||3.710|-1.348|
71755213|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|1.3201|||TWO_SIDED|95.0|-2.498|2.71||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||2.710|-2.498|
71787893|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.196|||||TWO_SIDED|95.0|-0.535|0.143|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.||0.143|-0.535|
71671105|NCT04242446|142860071|SUPERIORITY||Odds Ratio (OR)|2.175||||0.021|TWO_SIDED|97.5|1.021|4.635|||Regression, Logistic|||||4.635|1.021|0.021
71671106|NCT04242446|142860072|SUPERIORITY||LS mean difference|-2.574||||0.002|TWO_SIDED|97.5|-4.472|-0.675||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||-0.675|-4.472|0.002
71671107|NCT04242446|142860072|SUPERIORITY||LS mean difference|-2.682|||<|0.001|TWO_SIDED|97.5|-4.394|-0.97|||ANCOVA|||||-0.970|-4.394|<0.001
71755214|NCT00674817|143013018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.713|STANDARD_ERROR_OF_MEAN|1.3241|||TWO_SIDED|95.0|-3.325|1.899||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.899|-3.325|
71755215|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.561|STANDARD_ERROR_OF_MEAN|1.2351|||TWO_SIDED|95.0|-2.997|1.876||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||1.876|-2.997|
71755216|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.705|STANDARD_ERROR_OF_MEAN|1.2125|||TWO_SIDED|95.0|-0.687|4.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||4.097|-0.687|
71755217|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.337|STANDARD_ERROR_OF_MEAN|1.2341|||TWO_SIDED|95.0|-3.771|1.098||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.098|-3.771|
71755218|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.067|STANDARD_ERROR_OF_MEAN|1.2416|||TWO_SIDED|95.0|-3.516|1.382||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||1.382|-3.516|
71755219|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.376|STANDARD_ERROR_OF_MEAN|1.0997|||TWO_SIDED|95.0|-2.545|1.794||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.794|-2.545|
71755220|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|1.0786|||TWO_SIDED|95.0|-1.588|2.668||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||2.668|-1.588|
71755221|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|1.0999|||TWO_SIDED|95.0|-2.185|2.154||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.154|-2.185|
71755222|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.1058|||TWO_SIDED|95.0|-1.715|2.648||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||2.648|-1.715|
71755223|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.18|STANDARD_ERROR_OF_MEAN|0.881|||TWO_SIDED|95.0|-2.918|0.559||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.559|-2.918|
71787894|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.139|||||TWO_SIDED|95.0|-0.198|0.475|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.||0.475|-0.198|
71845574|NCT03244800|143205631|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71787895|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-1.18|0.9|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.||0.90|-1.18|
71787896|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.29|||||TWO_SIDED|95.0|-0.72|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.||1.30|-0.72|
71787897|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-1.15|0.8|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.||0.80|-1.15|
71787898|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.64|1.44|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.||1.44|-0.64|
71787899|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|-0.32|1.7|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.||1.70|-0.32|
71787900|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.74|1.2|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.||1.20|-0.74|
71755224|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.876|STANDARD_ERROR_OF_MEAN|0.8644|||TWO_SIDED|95.0|-0.829|2.582||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||2.582|-0.829|
71755225|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.809|STANDARD_ERROR_OF_MEAN|0.8882|||TWO_SIDED|95.0|-2.561|0.944||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.944|-2.561|
71787901|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-1.11|1.01|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.||1.01|-1.11|
71787902|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-0.57|1.62|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.||1.62|-0.57|
71787903|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.89|1.15|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.||1.15|-0.89|
71787904|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|-0.98|1.5|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.||1.50|-0.98|
71787905|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|-0.42|2.14|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.||2.14|-0.42|
71787906|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|-0.9|1.54|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.||1.54|-0.90|
71787907|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-1.2|1.3|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.||1.30|-1.20|
71787908|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|-0.53|2.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.||2.03|-0.53|
71787909|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.23|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.||1.23|-1.23|
71787910|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.22|||||TWO_SIDED|95.0|-0.78|1.23|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.||1.23|-0.78|
71787911|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|-0.21|1.89|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.||1.89|-0.21|
71671108|NCT04242446|142860073|SUPERIORITY||LS mean difference|-0.551||||0.201|TWO_SIDED|97.5|-1.521|0.418||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|ANCOVA|||||0.418|-1.521|0.201
71755226|NCT00674817|143013019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.8929|||TWO_SIDED|95.0|-2.122|1.401||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||1.401|-2.122|
71755227|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.2352|||TWO_SIDED|95.0|0.066|0.994||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.994|0.066|
71755228|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.388|STANDARD_ERROR_OF_MEAN|0.2318|||TWO_SIDED|95.0|-0.069|0.846||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.846|-0.069|
71755229|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2363|||TWO_SIDED|95.0|-0.157|0.775||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.775|-0.157|
71787912|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.49|||||TWO_SIDED|95.0|-0.5|1.48|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline glucose, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.||1.48|-0.50|
71755230|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.309|STANDARD_ERROR_OF_MEAN|0.2392|||TWO_SIDED|95.0|-0.163|0.78||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.780|-0.163|
71755231|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.874|STANDARD_ERROR_OF_MEAN|0.3099|||TWO_SIDED|95.0|0.262|1.485||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||1.485|0.262|
71755232|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.3056|||TWO_SIDED|95.0|-0.656|0.55||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.550|-0.656|
71755233|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.829|STANDARD_ERROR_OF_MEAN|0.3112|||TWO_SIDED|95.0|0.215|1.443||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.443|0.215|
71755234|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.567|STANDARD_ERROR_OF_MEAN|0.3151|||TWO_SIDED|95.0|-0.054|1.189||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||1.189|-0.054|
71755235|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.312|STANDARD_ERROR_OF_MEAN|0.1021|||TWO_SIDED|95.0|0.11|0.513||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.513|0.110|
71671109|NCT04242446|142860073|SUPERIORITY||LS mean difference|-1.186||||0.002|TWO_SIDED|97.5|-2.05|-0.322|||ANCOVA|||||-0.322|-2.050|0.002
71755236|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.1006|||TWO_SIDED|95.0|-0.025|0.372||||||GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||0.372|-0.025|
71755237|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1035|||TWO_SIDED|95.0|0.006|0.414||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.414|0.006|
71755238|NCT00674817|143013020|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.1047|||TWO_SIDED|95.0|-0.103|0.311||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.311|-0.103|
71755239|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.0503|||TWO_SIDED|95.0|-0.276|-0.078||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours||-0.078|-0.276|
71755240|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|-0.096|0.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.097|-0.096|
71755241|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.174|0.022||||||SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.022|-0.174|
71755242|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0507|||TWO_SIDED|95.0|-0.128|0.072||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours||0.072|-0.128|
71787913|NCT00372112|143073373|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.47|0.09|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.||0.09|-0.47|
71845575|NCT03244800|143205632|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71755243|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.166|STANDARD_ERROR_OF_MEAN|0.0493|||TWO_SIDED|95.0|-0.263|-0.069||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours||-0.069|-0.263|
71755244|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057|STANDARD_ERROR_OF_MEAN|0.0481|||TWO_SIDED|95.0|-0.152|0.038||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours||0.038|-0.152|
71755245|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.171|STANDARD_ERROR_OF_MEAN|0.0489|||TWO_SIDED|95.0|-0.267|-0.075||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours||-0.075|-0.267|
71845576|NCT03244800|143205633|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71845577|NCT03244800|143205634|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71845578|NCT03244800|143205635|SUPERIORITY||Odds Ratio (OR)|10.76||||0.04|TWO_SIDED|90.0|1.61|72.03|||Regression, Logistic|||||72.03|1.61|0.040
71845579|NCT05230433|143205665|OTHER||Percent Consumed|86.0||||0.15|TWO_SIDED|||||p-value was not adjusted for multiple comparisons|Chi-squared|||High fat agents were weighed pre- and post- providing the shake to the participant. All containers were tared to take into account straw, lid, and glass weight. Percentage of high-fat challenge consumed was calculated by post-shake weight / pre-shake weight. 13 out of 15 partcipants drank \>75% of the shake.||||0.15
71755246|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.0498|||TWO_SIDED|95.0|-0.108|0.089||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours||0.089|-0.108|
71755247|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.0522|||TWO_SIDED|95.0|-0.211|-0.005||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)||-0.005|-0.211|
71755248|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.0509|||TWO_SIDED|95.0|-0.087|0.114||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours||0.114|-0.087|
71755249|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.18|0.026||||||GSK961081 1200 mcg Plus SAL GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.026|-0.180|
71755250|NCT00674817|143013021|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.0529|||TWO_SIDED|95.0|-0.129|0.08||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)||0.080|-0.129|
71755251|NCT03199976|143013032|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
71787914|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.49|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.||0.04|-0.49|
71787915|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.46|0.07|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.||0.07|-0.46|
71787916|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.47|0.27|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.||0.27|-0.47|
71787917|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.73|-0.03|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.||-0.03|-0.73|
71787918|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.37|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.||0.34|-0.37|
71787919|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.97|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.97|
71787920|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.55|||||TWO_SIDED|95.0|-0.98|-0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.||-0.12|-0.98|
71787921|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.76|0.08|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.||0.08|-0.76|
71787922|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.26|0.33|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.||0.33|-0.26|
71755252|NCT03199976|143013033|SUPERIORITY|||||||0.595|||||||Chi-squared|||||||0.595
71755253|NCT03199976|143013034|SUPERIORITY||||||<|0.01||||||Bonferroni correction was applied in pairwise analyses.|Wilcoxon (Mann-Whitney)|||||||<0.01
71755254|NCT03199976|143013035|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71787923|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.||-0.10|-0.70|
71755255|NCT03697252|143013045|SUPERIORITY||LS mean difference|-11.56|||<|0.0001|TWO_SIDED|95.0|-16.07|-7.05|||Mixed model for repeated measures||||Statistics are from a mixed model for repeated measures (MMRM). The model includes the treatment group (KarXT or placebo), visit, and the interaction between the treatment group and visit as fixed factors, and baseline PANSS total score, site, age, and gender as covariates. An unstructured covariance matrix is used to model the correlation among repeated measurements and the denominator degrees of freedom are computed using the Kenward-Roger method.|-7.05|-16.07|<0.0001
71755256|NCT03697252|143013047|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of KarXT and Placebo at Week 5||||<0.001
71755257|NCT01780506|143013051|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.|Difference in percentages|0.5||||0.78|TWO_SIDED|95.002|-3.0|4.0||P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|Cochran-Mantel-Haenszel||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|||4.0|-3.0|0.78
71755258|NCT02435212|143013082|SUPERIORITY||Least squares mean|2.58|STANDARD_ERROR_OF_MEAN|2.803||0.3598|TWO_SIDED|95.0|-2.99|8.15|||ANCOVA|||||8.15|-2.99|0.3598
71755259|NCT02435212|143013083|SUPERIORITY||Least squares mean|176.36|STANDARD_ERROR_OF_MEAN|153.933||0.2546|TWO_SIDED|95.0|-129.0|481.72|||ANCOVA|||||481.72|-129.00|0.2546
71755260|NCT05179785|143013103|OTHER|||||||0.2938909|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.29389090
71755261|NCT05179785|143013103|OTHER|||||||0.97863544|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.97863544
71755262|NCT05179785|143013103|OTHER|||||||0.60236264|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.60236264
71755263|NCT05179785|143013103|OTHER|||||||0.35845126|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35845126
71755264|NCT05179785|143013103|OTHER|||||||0.91766025|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.91766025
71755265|NCT05179785|143013103|OTHER|||||||0.09605169|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delayed discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delayed discounting task"||||0.09605169
71755266|NCT05179785|143013104|OTHER|||||||0.50030946|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.50030946
71755267|NCT05179785|143013104|OTHER|||||||0.3751738|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.37517380
71787924|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.||0.34|-0.26|
71787925|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.15|||||TWO_SIDED|95.0|-0.42|0.12|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.||0.12|-0.42|
71787926|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.51|0.04|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.||0.04|-0.51|
71671110|NCT04242446|142860074|SUPERIORITY||Odds Ratio (OR)|1.618||||0.367|TWO_SIDED|97.5|0.489|5.352||Nominal p-value only due to the testing hierarchy failing on the HISCR50 outcome.|Regression, Logistic|||||5.352|0.489|0.367
71755268|NCT05179785|143013104|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
71755269|NCT05179785|143013104|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
71755270|NCT05179785|143013104|OTHER|||||||0.47876971|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.47876971
71755271|NCT05179785|143013104|OTHER|||||||0.21798816|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21798816
71755272|NCT05179785|143013105|OTHER|||||||0.75298499|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75298499
71755273|NCT05179785|143013105|OTHER|||||||0.16043787|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.16043787
71755274|NCT05179785|143013105|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
71755275|NCT05179785|143013105|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
71787927|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.34|0.21|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.||0.21|-0.34|
71671111|NCT04242446|142860074|SUPERIORITY||Odds Ratio (OR)|2.757||||0.041|TWO_SIDED|97.5|0.909|8.364|||Regression, Logistic|||||8.364|0.909|0.041
71755276|NCT05179785|143013105|OTHER|||||||0.67902693|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.67902693
71755277|NCT05179785|143013105|OTHER|||||||0.33832977|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.33832977
71755278|NCT05179785|143013106|OTHER|||||||0.73357221|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.73357221
71671112|NCT03349060|142860115|SUPERIORITY||Difference in Percentage|15.8||||0.0037|TWO_SIDED|95.0|6.8|24.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.8|6.8|0.0037
71787928|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.25|0.35|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.||0.35|-0.25|
71787929|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.66|-0.05|||Regression, Linear|||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.||-0.05|-0.66|
71787930|NCT00372112|143073373|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.26|0.34|||Regression, Linear|Analysis performed using linear regression ANCOVA with covariates of Baseline potassium, gender, age and treatment.||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.||0.34|-0.26|
71787931|NCT01025791|143073388|OTHER||0.1 mg vs. placebo|-7.06||||0.003|TWO_SIDED|90.0|-11.1|-3.0|||ANOVA|||||-3.00|-11.1|0.003
71787932|NCT01025791|143073388|OTHER||0.2 mg vs. placebo|-1.23||||0.31|TWO_SIDED|90.0|-5.42|2.96|||ANOVA|||||2.96|-5.42|0.310
71787933|NCT01025791|143073388|OTHER||0.5 mg vs. placebo|0.01||||0.498|TWO_SIDED|90.0|-4.05|4.06|||ANOVA|||||4.06|-4.05|0.498
71787934|NCT01025791|143073388|OTHER||1 mg vs. placebo|-5.69||||0.012|TWO_SIDED|90.0|-9.74|-1.63|||ANOVA|||||-1.63|-9.74|0.012
71892103|NCT03128957|143305753|EQUIVALENCE|Given the small sample permutation are feasible.||||||0.036|||||||permutation test|Given the non-parametric nature of spearman's correlation coefficient and a small sample we used a permutation test to calculate p-values.||Non-parametric covariance adjusted Spearman's correlation ρ\_s. To test the Null that Ho: ρ\_s.=0 vs alternative that Ha: ρ\_s.≠0, we used a method that calculates the probability that it would be greater than or equal to the observed ρ ̂, given the null hypothesis, by using a permutation test. An advantage of this approach is that it automatically takes into account the number of tied data values in the sample and the way they are treated in computing the rank correlation.||||0.036
71892104|NCT03128957|143305754|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.015
71755279|NCT05179785|143013106|OTHER|||||||0.43954526|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.43954526
71755280|NCT05179785|143013106|OTHER|||||||0.4419898|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.44198980
71755281|NCT05179785|143013106|OTHER|||||||0.39565784|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.39565784
71755282|NCT05179785|143013106|OTHER|||||||0.35602382|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.35602382
71787935|NCT01025791|143073388|OTHER||1 mg + 0.8 mg vs. placebo|-3.97||||0.059|TWO_SIDED|90.0|-8.16|0.22|||ANOVA|||||0.22|-8.16|0.059
71787936|NCT01025791|143073388|OTHER||0.4 mg vs. placebo|2.22||||0.191|TWO_SIDED|90.0|-2.09|6.54|||ANOVA|||||6.54|-2.09|0.191
71787937|NCT01025791|143073388|OTHER||1.2 mg vs. placebo|1.24||||0.333|TWO_SIDED|90.0|-3.67|6.15|||ANOVA|||||6.15|-3.67|0.333
71787938|NCT01025791|143073388|OTHER||1.2 mg + 0.6 mg vs. placebo|-1.43||||0.314|TWO_SIDED|90.0|-6.5|3.63|||ANOVA|||||3.63|-6.50|0.314
71787939|NCT01025791|143073388|OTHER||1 mg + 0.8 mg vs. placebo|-9.31||||0.001|TWO_SIDED|90.0|-14.2|-4.37|||ANOVA|||||-4.37|-14.2|0.001
71787940|NCT01025791|143073388|OTHER||1.2 mg + 1.0 mg vs. placebo|-6.45||||0.017|TWO_SIDED|90.0|-11.4|-1.51|||ANOVA|||||-1.51|-11.4|0.017
71787941|NCT01025791|143073388|OTHER||1.0 mg + 0.6 mg + 0.6 mg vs. placebo|-9.96||||0.001|TWO_SIDED|90.0|-14.9|-5.02|||ANOVA|||||-5.02|-14.9|0.001
71787942|NCT01025791|143073388|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|-9.0||||0.002|TWO_SIDED|95.0|-13.8|-4.17|||ANOVA|||||-4.17|-13.8|0.002
71787943|NCT01025791|143073393|OTHER||GMR (Fed/Fasted)|0.89|||||TWO_SIDED|95.0|0.86|0.92||||||||0.92|0.86|
71787944|NCT01025791|143073394|OTHER||GMR (Fed/fasted)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
71787945|NCT01025791|143073395|OTHER||0.1 mg vs placebo|-0.53||||0.396|TWO_SIDED|90.0|-3.92|2.86|||ANOVA|||||2.86|-3.92|0.396
71787946|NCT01025791|143073395|OTHER||0.2 mg vs. placebo|2.33||||0.1329|TWO_SIDED|90.0|-1.17|5.83|||ANOVA|||||5.83|-1.17|0.1329
71787947|NCT01025791|143073395|OTHER||0.5mg vs. placebo|-2.96||||0.0741|TWO_SIDED|90.0|-6.35|0.43|||ANOVA|||||0.43|-6.35|0.0741
71787948|NCT01025791|143073395|OTHER||1 mg vs. placebo|7.08|||<|0.001|TWO_SIDED|90.0|3.69|10.47|||ANOVA|||||10.47|3.69|<0.001
71787949|NCT01025791|143073395|OTHER||1 mg + 0.8 mg vs. placebo|4.39||||0.0211|TWO_SIDED|90.0|0.89|7.09|||ANOVA|||||7.09|0.89|0.0211
71755283|NCT05179785|143013106|OTHER|||||||0.30499144|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.30499144
71755284|NCT05179785|143013107|OTHER|||||||0.81601415|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.81601415
71755285|NCT05179785|143013107|OTHER|||||||0.20563452|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20563452
71787950|NCT01025791|143073395|OTHER||0.4 mg vs. placebo|0.85||||0.399|TWO_SIDED|90.0|-4.79|6.48|||ANOVA|||||6.48|-4.79|0.399
71787951|NCT01025791|143073395|OTHER||1.2 mg vs. placebo|4.54||||0.1|TWO_SIDED|90.0|-1.94|11.02|||ANOVA|||||11.02|-1.94|0.100
71787952|NCT01025791|143073395|OTHER||1.2 mg + 0.6 mg vs. placebo|3.38||||0.195|TWO_SIDED|90.0|-3.29|10.06|||ANOVA|||||10.06|-3.29|0.195
71671113|NCT03349060|142860115|SUPERIORITY||Difference in Percentage|36.0|||<|0.0001|TWO_SIDED|95.0|26.2|45.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.7|26.2|<0.0001
71671114|NCT03349060|142860116|SUPERIORITY||Difference in Percentage|27.9|||<|0.0001|TWO_SIDED|95.0|17.4|38.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.3|17.4|<0.0001
71671115|NCT03349060|142860116|SUPERIORITY||Difference in Percentage|51.0|||<|0.0001|TWO_SIDED|95.0|40.5|61.5|||Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||61.5|40.5|<0.0001
71755286|NCT05179785|143013107|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
71755287|NCT05179785|143013107|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
71755288|NCT05179785|143013107|OTHER|||||||0.21947623|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.21947623
71755289|NCT05179785|143013107|OTHER|||||||0.45535329|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.45535329
71755290|NCT05179785|143013108|OTHER|||||||0.83462055|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.83462055
71755291|NCT05179785|143013108|OTHER|||||||0.21582586|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.21582586
71755292|NCT05179785|143013108|OTHER|||||||0.59574875|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.59574875
71755293|NCT05179785|143013108|OTHER|||||||0.75948776|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.75948776
71755294|NCT05179785|143013108|OTHER|||||||0.7238414|||||||t-test, 2 sided|||"Paired t-test examining delayed choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.72384140
71755295|NCT05179785|143013108|OTHER|||||||0.00477281|||||||t-test, 2 sided|||"Paired t-test examining immediate choices on the delay discounting task (post versus pre).~One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task"||||0.00477281
71755296|NCT05179785|143013109|OTHER|||||||0.20047055|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.20047055
71755297|NCT05179785|143013109|OTHER|||||||0.77922802|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.77922802
71755298|NCT05179785|143013109|OTHER|||||||0.29196708|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.29196708
71787953|NCT01025791|143073395|OTHER||1.0 mg + 0.8 mg vs. placebo|9.16||||0.022|TWO_SIDED|90.0|1.74|16.58|||ANOVA|||||16.58|1.74|0.022
71787954|NCT01025791|143073395|OTHER||1.2 mg + 1.0 mg vs. placebo|5.74||||0.098|TWO_SIDED|90.0|-1.68|13.16|||ANOVA|||||13.16|-1.68|0.098
71787955|NCT01025791|143073395|OTHER||1 mg + 0.6 mg + 0.6 mg vs. placebo|3.48||||0.214|TWO_SIDED|90.0|-3.94|10.9|||ANOVA|||||10.90|-3.94|0.214
71787956|NCT01025791|143073395|OTHER||1 mg + 1 mg + 0.6 mg vs. placebo|4.24||||0.163|TWO_SIDED|95.0|-3.03|11.52|||ANOVA|||||11.52|-3.03|0.163
71892105|NCT03128957|143305755|SUPERIORITY|||||||0.047|||||||Kruskal-Wallis|||Set point 1 (FiO2 0.3 and PaCO2 30 mmHg) compared to set point 2 (FiO2 1.0 and PaCO2 40 mmHg)||||0.047
71671116|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|18.0||||0.0004|TWO_SIDED|95.0|10.2|25.8|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.8|10.2|0.0004
71755299|NCT05179785|143013109|OTHER|||||||0.05605962|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.05605962
71755300|NCT05179785|143013109|OTHER|||||||0.57368284|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.57368284
71755301|NCT05179785|143013109|OTHER|||||||0.56397238|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.56397238
71755302|NCT05179785|143013110|OTHER|||||||0.86107891|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.86107891
71671117|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|42.5|||<|0.0001|TWO_SIDED|95.0|33.6|51.4|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||51.4|33.6|<0.0001
71671118|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|15.0||||0.0251|TWO_SIDED|95.0|1.9|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|1.9|0.0251
71671119|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|41.1|||<|0.0001|TWO_SIDED|95.0|27.8|54.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||54.4|27.8|<0.0001
71671120|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|20.0||||0.0019|TWO_SIDED|95.0|7.4|32.7|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||32.7|7.4|0.0019
71755303|NCT05179785|143013110|OTHER|||||||0.62228799|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62228799
71755304|NCT05179785|143013110|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
71755305|NCT05179785|143013110|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
71755306|NCT05179785|143013110|OTHER|||||||0.79477883|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.79477883
71755307|NCT05179785|143013110|OTHER|||||||0.12634435|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (dorsal anterior cingulate cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.12634435
71755308|NCT05179785|143013110|OTHER|||||||0.62461968|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.62461968
71755309|NCT05179785|143013110|OTHER|||||||0.51324793|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.51324793
71755310|NCT05179785|143013110|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
71755311|NCT05179785|143013110|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
71755312|NCT05179785|143013110|OTHER|||||||0.60543603|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.60543603
71755313|NCT05179785|143013110|OTHER|||||||0.75565448|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre) (posterior parietal cortex). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.75565448
71755314|NCT05179785|143013111|OTHER|||||||0.09266386|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.09266386
71755315|NCT05179785|143013111|OTHER|||||||0.53980185|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.53980185
71787957|NCT04649060|143073396|SUPERIORITY||Hazard Ratio (HR)|0.184|||=|0.0032|TWO_SIDED|95.0|0.052|0.65|||Log Rank|||||0.650|0.052|=0.0032
71787958|NCT04649060|143073397|SUPERIORITY|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
71787959|NCT04649060|143073398|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.525|TWO_SIDED|95.0|0.026|6.693|||Log Rank|||||6.693|0.026|0.525
71787960|NCT04649060|143073400|SUPERIORITY|||||||0.0997|||||||Cochran-Mantel-Haenszel|||||||0.0997
71787961|NCT04649060|143073401|SUPERIORITY||Hazard Ratio (HR)|0.111||||0.016|TWO_SIDED|95.0|0.013|0.96|||Log Rank|||||0.960|0.013|0.016
71671121|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|45.3|||<|0.0001|TWO_SIDED|95.0|32.7|57.8|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.8|32.7|<0.0001
71787962|NCT04649060|143073403|SUPERIORITY||Hazard Ratio (HR)|0.231||||0.0187|TWO_SIDED|95.0|0.063|0.846|||Log Rank|||||0.846|0.063|0.0187
71787963|NCT04649060|143073404|SUPERIORITY||Hazard Ratio (HR)|0.224||||0.0384|TWO_SIDED|95.0|0.047|1.056|||Log Rank|||||1.056|0.047|0.0384
71787964|NCT04649060|143073405|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.3721|TWO_SIDED|95.0|0.086|2.569|||Log Rank|||||2.569|0.086|0.3721
71892106|NCT05198713|143305757|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71755316|NCT05179785|143013111|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
71755317|NCT05179785|143013111|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
71671122|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|22.5||||0.0003|TWO_SIDED|95.0|10.3|34.8|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||34.8|10.3|0.0003
71671123|NCT03349060|142860117|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|29.6|53.9|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.9|29.6|<0.0001
71671124|NCT03349060|142860118|SUPERIORITY||Difference in Percentage|16.3||||0.0055|TWO_SIDED|95.0|7.4|25.2|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||25.2|7.4|0.0055
71787965|NCT04044716|143073411|SUPERIORITY|||||||0.048|||||||ANCOVA|age, joint involved in surgery, sex, baseline pain||||||.048
71755318|NCT05179785|143013111|OTHER|||||||0.30223686|||||||t-test, 2 sided|||Paired t-test examining delayed choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.30223686
71755319|NCT05179785|143013111|OTHER|||||||0.39166649|||||||t-test, 2 sided|||Paired t-test examining immediate choices on the delay discounting task (post versus pre). One participant was excluded from the EEG data analysis due to lack of immediate choices on the delay discounting task||||0.39166649
71787966|NCT04044716|143073412|SUPERIORITY|||||||0.29|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline pain||||||0.29
71787967|NCT04044716|143073413|SUPERIORITY|||||||0.64|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline morphine milligram equivalents (MME)||||||0.64
71787968|NCT04044716|143073414|SUPERIORITY|||||||0.86|||||||ANCOVA|adjusted for age, sex, type of surgery (joint), baseline MME, and time in hospital||||||0.86
71787969|NCT04044716|143073415|SUPERIORITY|||||||0.661||||||adjusted for age, type of surgery (joint), and sex|ANCOVA|||||||0.661
71787970|NCT01018186|143073440|SUPERIORITY_OR_OTHER||Ratio|1.67|||||TWO_SIDED|95.0|1.34|2.08|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||2.08|1.34|
71787971|NCT01018186|143073440|SUPERIORITY_OR_OTHER||Ratio|1.65|||||TWO_SIDED|95.0|1.29|2.13|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||2.13|1.29|
71787972|NCT01018186|143073440|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.83|1.33|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.33|0.83|
71787973|NCT01018186|143073440|SUPERIORITY_OR_OTHER||Ratio|1.52|||||TWO_SIDED|95.0|1.22|1.89|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12|||1.89|1.22|
71787974|NCT01018186|143073440|SUPERIORITY_OR_OTHER||Ratio|1.43|||||TWO_SIDED|95.0|1.11|1.84|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28|||1.84|1.11|
71787975|NCT01018186|143073440|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|95.0|0.87|1.38|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52|||1.38|0.87|
71787976|NCT01018186|143073441|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.67|||<|0.001|TWO_SIDED|95.0|1.34|2.08|||ANCOVA|||||2.08|1.34|<0.001
71787977|NCT01018186|143073441|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.52|||<|0.001|TWO_SIDED|95.0|1.22|1.89|||ANCOVA|||||1.89|1.22|<0.001
71787978|NCT01018186|143073442|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.65|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||ANCOVA|||||2.13|1.29|<0.001
71787979|NCT01018186|143073442|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||ANCOVA|||||1.84|1.11|0.006
71787980|NCT01018186|143073443|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.05||||0.674|TWO_SIDED|95.0|0.83|1.33|||ANCOVA|||||1.33|0.83|0.674
71787981|NCT01018186|143073443|SUPERIORITY_OR_OTHER||Ratio of LSGM to Baseline|1.09||||0.444|TWO_SIDED|95.0|0.87|1.38|||ANCOVA|||||1.38|0.87|0.444
71787982|NCT03552198|143073460|OTHER|||||||0.964|||||||ANCOVA|ANCOVA, adjusted for baseline measures, tested for differences between intervention and control groups in preventative behaviours at 4 weeks||We predicted that the groups receiving the alternative format of air quality notifications would report greater frequency of behaviour change at 4 weeks compared to the groups receiving the usual format.||||.964
71787983|NCT03552198|143073461|OTHER|||||||0.043|||||||Chi-squared|χ2(1)=4.11, V=0.229||We predicted that more respondents in the intervention groups (i.e. receiving alternative health advice) would consider making permanent changes to their daily travel route, exercise location or exercise time compared to the control groups||||0.043
71787984|NCT03552198|143073462|OTHER||||||>|0.05|||||||Fisher Exact|||We predicted that the alternative health advice would lead to greater actual behaviour change compared to the usual format||||>0.05
71787985|NCT03552198|143073463|OTHER||||||>|0.05|||||||ANCOVA|ANCOVA, adjusted for baseline intentions, tested for differences between groups in intentions in relation to an high-air-pollution scenario at 4 weeks||We predicted that the alternative format would lead to stronger intentions to adhere to recommendations associated with an hypothetical high air pollution episode compared to the usual format.||||>0.05
71755320|NCT05179785|143013112|OTHER|||||||0.0265|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0265
71755321|NCT05179785|143013112|OTHER|||||||0.1053|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.1053
71755322|NCT05179785|143013112|OTHER|||||||0.0033|||||||t-test, 2 sided|||Paired t-test (post versus pre)||||0.0033
71755323|NCT05966142|143013113|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.5913|TWO_SIDED|95.0|-0.42|0.74|||t-test, 2 sided|||||0.74|-0.42|0.5913
71755324|NCT05966142|143013114|SUPERIORITY|||||||0.6803|||||||t-test, 2 sided|||||||0.6803
71755325|NCT05966142|143013115|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
71755326|NCT05966142|143013116|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.5252|TWO_SIDED|95.0|-1.7|0.9|||t-test, 2 sided|||||0.9|-1.7|0.5252
71755327|NCT05966142|143013117|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
71755328|NCT04852302|143013122|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-1.81|STANDARD_DEVIATION|4.81||0.168|TWO_SIDED|95.0|-4.47|0.86||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||Null hypothesis was that the mean difference between the paired observations is zero.||0.86|-4.47|0.168
71755329|NCT04852302|143013123|EQUIVALENCE|We evaluated the same group to determine whether their reported depression was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-0.3|STANDARD_DEVIATION|3.59||0.752|TWO_SIDED|95.0|-2.29|1.69||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||1.69|-2.29|0.752
71755330|NCT04852302|143013124|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 3-months compared to baseline.|Mean Difference (Net)|-4.67|STANDARD_DEVIATION|16.26||0.285|TWO_SIDED|95.0|-13.67|4.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||4.34|-13.67|0.285
71755331|NCT04852302|143013124|EQUIVALENCE|We evaluated the same group to determine whether their reported anxiety via the Death and Dying Distress Scale was the same, worse, or better at 6-months compared to baseline.|Mean Difference (Net)|-2.2|STANDARD_DEVIATION|17.22||0.628|TWO_SIDED|95.0|-11.74|7.34||The a priori threshold for statistical significance was \< 0.05. We did not adjust for multiple comparisons as this was exploratory.|paired sample t-Test, 2-sided|||||7.34|-11.74|0.628
71755332|NCT00135226|143013171|OTHER||Rate Ratio|0.88||||0.01|TWO_SIDED|95.0|0.79|0.97|||Log Rank|||||0.97|0.79|0.01
71755333|NCT00135226|143013171|OTHER||Rate Ratio|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08|||Log Rank|||||1.08|0.87|0.55
71755334|NCT00135226|143013172|OTHER||Rate Ratio|1.29||||0.003|TWO_SIDED|95.0|1.09|1.52|||Log Rank|||||1.52|1.09|0.003
71755335|NCT00135226|143013173|OTHER||Rate Ratio|0.88|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
71755336|NCT00135226|143013173|OTHER||Rate Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.09||||||||1.09|0.91|
71755337|NCT00135226|143013174|OTHER||Rate Ratio|0.99|||||TWO_SIDED|95.0|0.8|1.24||||||||1.24|0.80|
71755338|NCT00135226|143013175|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.04||||||||1.04|0.85|
71755339|NCT00135226|143013175|OTHER||Risk Ratio|0.95|||||TWO_SIDED|95.0|0.86|1.05||||||||1.05|0.86|
71755340|NCT00135226|143013176|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||||1.12|0.66|
71755341|NCT00135226|143013176|OTHER||Rate ratio|0.79|||||TWO_SIDED|95.0|0.61|1.02||||||||1.02|0.61|
71755342|NCT00135226|143013177|OTHER||Rate Ratio|1.12|||||TWO_SIDED|95.0|0.7|1.77||||||||1.77|0.7|
71755343|NCT00135226|143013177|OTHER||Rate Ratio|0.94|||||TWO_SIDED|95.0|0.59|1.5||||||||1.50|0.59|
71755344|NCT00135226|143013178|OTHER||Rate Ratio|0.96|||||TWO_SIDED|95.0|0.68|1.34||||||||1.34|0.68|
71755345|NCT00135226|143013178|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.57|1.12||||||||1.12|0.57|
71755346|NCT00135226|143013179|OTHER||Rate Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15||||||||1.15|0.84|
71755347|NCT00135226|143013179|OTHER||Rate ratio|0.95|||||TWO_SIDED|95.0|0.82|1.12||||||||1.12|0.82|
71755348|NCT00135226|143013180|OTHER||Rate ratio|1.19|||||TWO_SIDED|95.0|0.86|1.63||||||||1.63|0.86|
71755349|NCT00135226|143013180|OTHER||Rate Ratio|0.93|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
71755350|NCT00135226|143013181|OTHER||Rate Ratio|0.8|||||TWO_SIDED|95.0|0.64|1.01||||||||1.01|0.64|
71755351|NCT00135226|143013181|OTHER||Rate Ratio|1.26|||||TWO_SIDED|95.0|1.0|1.59||||||||1.59|1.00|
71755352|NCT00135226|143013182|OTHER||Rate Ratio|0.86|||||TWO_SIDED|95.0|0.46|1.6||||||||1.60|0.46|
71755353|NCT00135226|143013182|OTHER||Rate ratio|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
71755354|NCT00135226|143013183|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.3||||||||3.30|0.17|
71755355|NCT00135226|143013183|OTHER||Rate Ratio|0.75|||||TWO_SIDED|95.0|0.17|3.31||||||||3.31|0.17|
71755356|NCT00135226|143013184|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
71755357|NCT00135226|143013184|OTHER||Risk Ratio|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.10|0.91|
71755358|NCT00135226|143013185|OTHER||Rate Ratio|1.06|||||TWO_SIDED|95.0|0.78|1.43||||||||1.43|0.78|
71755359|NCT00135226|143013186|OTHER||Rate ratio|0.98|||||TWO_SIDED|95.0|0.74|1.29||||||||1.29|0.74|
71755360|NCT00135226|143013186|OTHER||Rate Ratio|1.04|||||TWO_SIDED|95.0|0.79|1.37||||||||1.37|0.79|
71755361|NCT00135226|143013187|OTHER||Rate Ratio|1.13|||||TWO_SIDED|95.0|0.97|1.32||||||||1.32|0.97|
71755362|NCT00135226|143013187|OTHER||Rate Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.25||||||||1.25|0.91|
71755363|NCT00135226|143013188|OTHER||Rate Ratio|1.02|||||TWO_SIDED|95.0|0.76|1.38||||||||1.38|0.76|
71755364|NCT00135226|143013188|OTHER||Rate Ratio|1.17|||||TWO_SIDED|95.0|0.87|1.58||||||||1.58|0.87|
71755365|NCT00135226|143013189|OTHER||Rate Ratio|1.01|||||TWO_SIDED|95.0|0.76|1.34||||||||1.34|0.76|
71755366|NCT00135226|143013189|OTHER||Rate Ratio|1.14|||||TWO_SIDED|95.0|0.86|1.52||||||||1.52|0.86|
71755367|NCT00135226|143013190|OTHER||Rate Ratio|0.85|||||TWO_SIDED|95.0|0.58|1.23||||||||1.23|0.58|
71755368|NCT00135226|143013190|OTHER||Rate ratio|1.02|||||TWO_SIDED|95.0|0.7|1.48||||||||1.48|0.70|
71755369|NCT00135226|143013191|OTHER||Rate Ratio|0.83|||||TWO_SIDED|95.0|0.49|1.41||||||||1.41|0.49|
71755370|NCT00135226|143013191|OTHER||Rate Ratio|0.72|||||TWO_SIDED|95.0|0.42|1.22||||||||1.22|0.42|
71755371|NCT00135226|143013192|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.5|1.41||||||||1.41|0.50|
71755372|NCT00135226|143013192|OTHER||Rate Ratio|0.78|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
71755373|NCT00135226|143013193|OTHER||Rate Ratio|1.23|||||TWO_SIDED|95.0|0.98|1.54||||||||1.54|0.98|
71755374|NCT00135226|143013194|OTHER||Rate Ratio|0.84|||||TWO_SIDED|95.0|0.63|1.12||||||||1.12|0.63|
71755375|NCT04531176|143013217|NON_INFERIORITY|The results of non-inferiority test results are between pairwise groups. Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison.||||||0.004||||||The non-inferiority regions were set to be 1% for weight loss change. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.004
71755376|NCT04531176|143013218|NON_INFERIORITY|Non-inferiority was tested at the 0.05 level at 1 year and performed pairwise with Bonferroni adjusted significance levels for each paired comparison||||||0.05||||||The non-inferiority regions were set to be 0.5% for A1C. When both primary endpoints are non-inferior, superiority testing at the 0.025 overall error level with Bonferroni adjustment for each endpoint at 1 year was then performed.|t-test, 1 sided|||||||0.05
71755377|NCT01345240|143013389|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.|Difference in percent seroprotection|-3.95|||||TWO_SIDED|95.0|-7.12|-2.16||||||Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.||-2.16|-7.12|
71755378|NCT01345240|143013392|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|0.91|||||TWO_SIDED|95.0|0.69|1.2|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.20|0.69|
71755379|NCT01345240|143013392|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.32|0.76|
71755380|NCT01345240|143013392|EQUIVALENCE|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within \[0.5, 2\].|GMC ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANOVA|||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.||1.45|0.84|
71755381|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.15|||||TWO_SIDED|95.0|0.95|1.39|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.39|0.95|
71755382|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.2|||||TWO_SIDED|95.0|0.97|1.48|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.48|0.97|
71755383|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.27|||||TWO_SIDED|95.0|1.06|1.52|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.52|1.06|
71755384|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.17|||||TWO_SIDED|95.0|0.83|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.83|
71755385|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.94|1.33|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.33|0.94|
71755386|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.32|||||TWO_SIDED|95.0|1.08|1.63|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.63|1.08|
71755387|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.77|1.27|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.27|0.77|
71755388|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.81|||||TWO_SIDED|95.0|1.38|2.38|||ANOVA|||To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||2.38|1.38|
71755389|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.21|||||TWO_SIDED|95.0|0.89|1.65|||ANOVA|||To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.65|0.89|
71755390|NCT01345240|143013400|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||TWO_SIDED|95.0|0.81|1.55|||ANOVA|||To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.||1.55|0.81|
71755391|NCT01345240|143013406|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.2|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.20|0.97|
71755392|NCT01345240|143013406|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||TWO_SIDED|95.0|0.97|1.21|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.21|0.97|
71755393|NCT01345240|143013406|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||ANOVA|||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.||1.22|0.98|
71755394|NCT01345240|143013407|NON_INFERIORITY|Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.11|||||TWO_SIDED|95.0|0.76|1.61|||ANOVA|||To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen||1.61|0.76|
71755395|NCT00449696|143013419|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.91||||0.122||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.122
71755396|NCT00449696|143013420|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42||||0.071||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.071
71755397|NCT00449696|143013421|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.64||||0.058||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.058
71755398|NCT00449696|143013422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.022||95.0||||P-value for strict OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.022
71755399|NCT00449696|143013422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.242||95.0||||P-value for OMERACT-OARSI response.|Generalized Estimating Equation Model|||||||0.242
71755400|NCT00449696|143013423|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||P-value for physical component scores, physical function subscale, role physical subscale, and bodily pain subscale.|Wilcoxon (Mann-Whitney)|||||||>0.05
71755401|NCT00449696|143013424|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.39||||0.037||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.037
71755402|NCT00449696|143013425|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92||||0.746||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.746
71755403|NCT00449696|143013426|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.166||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.|||||0.166
71755404|NCT00449696|143013427|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.041
71755405|NCT01903460|143013446|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-40.707||||0.574|TWO_SIDED|95.0|-191.679|110.265|||ANCOVA|||Analysis of LUM001 140ug/kg/day||110.265|-191.679|0.5740
71837202|NCT01552473|143181138|OTHER|This is a functional Magnetic Resonance Imaging analysis. We aimed to determine whether functional brain network connectivity was equivalent between the two intervention arms prior to the interventions beginning. This was computed in significant numbers of connections between the two groups.|pNBS|0.0001||||0.01|TWO_SIDED|||||This is a p-value that is used in Network Based Statistics analysis for resting-state functional brain network data.|Network Based Statistics analysis|This is a type of statistical analysis used to test for group differences among functional connectivity levels between two or more groups.|This analysis evaluated monotonic changes from time point 1 (pre-intervention) to time points 2 (immediate post-intervention) and 3 (12 weeks post-intervention) that may have occurred between the SMART and BHW groups.|A network-based statistics analysis was carried out to determine brain connectivity differences observed at time points two (initial post-intervention testing phase) and three (the final post-intervention phase) occurring three months post-intervention.||||0.01
71837203|NCT05089734|143181162|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0534|TWO_SIDED|95.0|0.68|1.04||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.04|0.68|0.0534
71837204|NCT05089734|143181163|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1938|TWO_SIDED|95.0|0.77|1.11||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||1.11|0.77|0.1938
71837205|NCT05089734|143181164|SUPERIORITY||Difference in Proportions|-4.3||||0.9255|TWO_SIDED|95.0|-10.1|1.5||The 1-sided p-value is calculated using Cochran Mantel-Haenszel test adjusted for randomization stratification factors of histology, and best response to last prior immune therapy received.|Cochran-Mantel-Haenszel|||||1.5|-10.1|0.9255
71837206|NCT05089734|143181169|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.002|TWO_SIDED|95.0|0.61|0.91||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.91|0.61|0.0020
71837207|NCT05089734|143181170|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0125|TWO_SIDED|95.0|0.66|0.97||Stratified log-rank test adjusted for stratification factors: histology and best response to last prior immune therapy received.|Log Rank|||||0.97|0.66|0.0125
71837208|NCT02754882|143181175|EQUIVALENCE|Pre-defined equivalence margin was \[0.737, 1.357\]|Risk Ratio (RR)|1.11|||||TWO_SIDED|90.0|0.975|1.269|||||SB8 vs. Avastin|||1.269|0.975|
71837209|NCT04648033|143181190|OTHER||Probability of DLT at dose level 4|0.116|||||TWO_SIDED|95.0|0.032|0.26||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.26|0.032|
71837210|NCT01212029|143181202|OTHER|One sample t-tests of standardized regression coefficients of RMSSD predicting O2Hb during baseline||||||0.008||||||t-test was performed 16 times for 16 fNIRS channels. The reported p-value is an uncorrected value for channel 10.|t-test, 2 sided|||Null hypothesis: there is no significant correlation between RMSSD and O2Hb levels during baseline||||0.008
71892107|NCT00824564|143305797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.5|STANDARD_ERROR_OF_MEAN|58.63||0.348|TWO_SIDED|95.0|-172.7|61.7|||t-test, 2 sided|||The mean difference with associated standard error (SE), and corresponding 95% confidence interval (CI) for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||61.7|-172.7|0.348
71892108|NCT00824564|143305798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.0|STANDARD_ERROR_OF_MEAN|32.78||0.466|TWO_SIDED|95.0|-41.3|89.3|||t-test, 2 sided|||The mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||89.3|-41.3|0.466
71755406|NCT01903460|143013446|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-7.231||||0.9147|TWO_SIDED|95.0|-148.726|134.264|||ANCOVA|||Analysis of LUM001 280ug/kg/day||134.264|-148.726|0.9147
71755407|NCT01903460|143013446|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-23.969||||0.6954|TWO_SIDED|95.0|-151.969|104.031|||ANCOVA|||Analysis of all doses of LUM001||104.031|-151.969|0.6954
71755408|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|56.7||||0.0783|TWO_SIDED|95.0|-7.2|120.6|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALT||120.6|-7.2|0.0783
71755409|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|7.8||||0.7827|TWO_SIDED|95.0|-51.4|67.0|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALT||67.0|-51.4|0.7827
71755410|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|32.2||||0.2235|TWO_SIDED|95.0|-21.9|86.3|||ANCOVA|||Analysis of all doses of LUM001 for ALT||86.3|-21.9|0.2235
71755411|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|24.0||||0.2372|TWO_SIDED|95.0|-17.5|65.5|||ANCOVA|||Analysis of LUM001 140ug/kg/day for AST||65.5|-17.5|0.2372
71755412|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-15.8||||0.3914|TWO_SIDED|95.0|-54.1|22.4|||ANCOVA|||Analysis of LUM001 280ug/kg/day for AST||22.4|-54.1|0.3914
71755413|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|4.1||||0.8081|TWO_SIDED|95.0|-31.0|39.1|||ANCOVA|||Analysis of all doses of LUM001 for AST||39.1|-31.0|0.8081
71755414|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|51.7||||0.5748|TWO_SIDED|95.0|-140.3|243.7|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALP||243.7|-140.3|0.5748
71755415|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|11.9||||0.8835|TWO_SIDED|95.0|-158.4|182.2|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALP||182.2|-158.4|0.8835
71837211|NCT01212029|143181203|OTHER|||||||0.0105|||||||Tukey method|||||||0.0105
71845580|NCT05230433|143205666|OTHER|No test vs. control groups.||||||0.65||||||This p-value is not adjusted for multiple comparisons.|Pearson Correlation|||Fold change from 60 to 180 minutes of average medium chain acylcarnitine was calculated for each participant. Pearson correlation between BMI percentile and fold change was calculated.|Pearson Correlation between both secondary outcomes reported: BMI percentile and fold change between acylcarnitine at 60 minutes and 180 minutes post the high fat challenge.|||0.65
71845581|NCT02927249|143205669|SUPERIORITY||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.91|1.56||||||||1.56|0.91|
71845582|NCT02927249|143205670|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.74|1.69||||||||1.69|0.74|
71755416|NCT01903460|143013447|SUPERIORITY_OR_OTHER||LS mean difference from placebo|31.8||||0.6917|TWO_SIDED|95.0|-135.8|199.4|||ANCOVA|||Analysis of all doses of LUM001 for ALP||199.4|-135.8|0.6917
71755417|NCT01903460|143013448|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.348||||0.6907|TWO_SIDED|95.0|-2.468|1.772|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Patient ItchRO||1.772|-2.468|0.6907
71755418|NCT01903460|143013448|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.202||||0.7897|TWO_SIDED|95.0|-1.647|2.052|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Patient ItchRO||2.052|-1.647|0.7897
71755419|NCT01903460|143013448|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.073||||0.9203|TWO_SIDED|95.0|-1.85|1.705|||ANCOVA|||Analysis of all doses of LUM001 for Patient ItchRO||1.705|-1.850|0.9203
71755420|NCT01903460|143013448|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.21||||0.5966|TWO_SIDED|95.0|-1.038|0.618|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Observer ItchRO||0.618|-1.038|0.5966
71755421|NCT01903460|143013448|SUPERIORITY_OR_OTHER||LS mean difference from placebo|0.173||||0.632|TWO_SIDED|95.0|-0.58|0.926|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Observer ItchRO||0.926|-0.580|0.6320
71755422|NCT01903460|143013448|SUPERIORITY_OR_OTHER||LS mean difference from placebo|-0.019||||0.9547|TWO_SIDED|95.0|-0.71|0.673|||ANCOVA|||Analysis of all doses of LUM001 for Observer ItchRO||0.673|-0.710|0.9547
71755423|NCT05712460|143013493|OTHER||Ratio|126.65|||||TWO_SIDED|90.0|106.87|150.1|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||150.10|106.87|
71755424|NCT05712460|143013494|OTHER||Ratio|142.94|||||TWO_SIDED|90.0|117.2|174.32|||||Analysis was performed using mixed effect model with sequence, and treatment as fixed effects and participant within sequence as a random effect.|||174.32|117.20|
71755425|NCT02735863|143013503|SUPERIORITY|||||||0.5352|||||||Log Rank|||||||0.5352
71755426|NCT00829426|143013504|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|Geometric Test/Ref Ratio x 100|102.56|||||TWO_SIDED|90.0|98.74|106.52|||||Bioequivalence is established when 90% Confidence Interval falls withi 80-125.|||106.52|98.74|
71755427|NCT00829426|143013505|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|92.88||||||90.0|90.34|95.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||95.48|90.34|
71671125|NCT03349060|142860118|SUPERIORITY||Difference in Percentage|43.3|||<|0.0001|TWO_SIDED|95.0|33.1|53.6|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||53.6|33.1|<0.0001
71755428|NCT00829426|143013506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|93.92||||||90.0|91.47|96.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||96.44|91.47|
71755429|NCT05560425|143013508|EQUIVALENCE|"The equivalence margin is a range of the compliance score for which the independent training of skills in each group is close enough to be considered equivalent."|Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|3.45|<|0.05|TWO_SIDED|95.0|-6.22|8.79|||t-test, 1 sided|degrees of freedom = 12||Null hypothesis: Compliance with independent training of skills is not equivalent between groups.||8.79|-6.22|<0.05
71755430|NCT02260934|143013516|SUPERIORITY|||||||0.58||||||Two-sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 24||||0.58
71845583|NCT02927249|143205671|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.83|1.52||||||||1.52|0.83|
71755431|NCT02260934|143013516|SUPERIORITY|||||||0.25||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 48||||0.25
71755432|NCT02260934|143013516|SUPERIORITY|||||||0.15||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 96.||||0.15
71755433|NCT02260934|143013518|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms.|||||||||||||Regression, Logistic|Two sided test. P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 24|Treatment group was the independent variable in the logistic regression.|||
71755434|NCT02260934|143013518|SUPERIORITY||||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms.||Week 0 to Week 48|P-value could not be produced because of zero count in at least one of the treatment arms.|||
71755435|NCT02260934|143013518|SUPERIORITY|P-value could not be produced because of zero count in at least one of the treatment arms|||||||||||||Regression, Logistic|P-value could not be produced because of zero count in at least one of the treatment arms||Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|P-value could not be produced because of zero count in at least one of the treatment arms|||
71755436|NCT02260934|143013519|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.66||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 24||||0.66
71755437|NCT02260934|143013519|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.65||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 48|Treatment group was the independent variable in the logistic regression.|||0.65
71755438|NCT02260934|143013520|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.64||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 24 Treatment group was the independent variable in the logistic regression.||||0.64
71755439|NCT02260934|143013520|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.37||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 48||||0.37
71755440|NCT02260934|143013520|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.32|||||||Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 96||||0.32
71755441|NCT02260934|143013521|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.91||||||2 sided test|Regression, Logistic|2 sided test||Week 96||||0.91
71755442|NCT02260934|143013522|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.73||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 24||||.73
71755443|NCT02260934|143013522|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.26||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 48||||0.26
71755444|NCT02260934|143013522|SUPERIORITY|Treatment group was the independent variable in the logistic regression.||||||0.29||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 96||||0.29
71755445|NCT02260934|143013523|SUPERIORITY|2 sided test|||||>|0.99||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 24||||>0.99
71755446|NCT02260934|143013524|SUPERIORITY|2 sided test||||||0.49||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 48||||0.49
71755447|NCT02260934|143013526|SUPERIORITY|2 sided test||||||0.89||||||2 sided test|Regression, Logistic|||Treatment group was the independent variable in the logistic regression.||||0.89
71755448|NCT02260934|143013526|SUPERIORITY|Week 48||||||0.47||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.47
71755449|NCT02260934|143013526|SUPERIORITY|Week 96||||||0.94||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.94
71755450|NCT02260934|143013527|SUPERIORITY|Week 24||||||0.08||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.08
71755451|NCT02260934|143013527|SUPERIORITY|Week 48||||||0.11||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.11
71755452|NCT02260934|143013527|SUPERIORITY|Week 96||||||0.05||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.05
71755453|NCT02260934|143013528|SUPERIORITY|Week 24||||||0.2||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||.20
71755454|NCT02260934|143013528|SUPERIORITY|Week 48|||||>|0.99||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||>0.99
71755455|NCT02260934|143013528|SUPERIORITY|Week 96||||||0.63||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.||||0.63
71755456|NCT05720897|143013553|SUPERIORITY|||||||0.399||||||The calculations are based on a Mann Whitney calculation.|Wilcoxon (Mann-Whitney)|||The study has an 80% power to detect changes in patient's self-reported anxiety as measured by their responses to the psychometrically validated STAI-S \& T instrument of 3.6 within each group (with an effect size of 0.55) and differences of a 5.0 between groups (with an effect size of 0.77).||||.399
71755457|NCT04780061|143013559|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||An area under the curve approach was used to analyze the primary outcome, whereby participants' scores for each assessment were summed over the 21-day period. For missing values, we imputed the mean of the most recent and first subsequent measurement or carried the last observation forward if there was no subsequent measurement.||||0.53
71755458|NCT04780061|143013561|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71755459|NCT04780061|143013562|SUPERIORITY|||||||0.81|||||||Log Rank|||||||0.81
71755460|NCT01456039|143013574|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)|Binomial test for dichotomized response|||||||<0.0001
71755461|NCT00335777|143013602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||0.289|TWO_SIDED|95.0|||||McNemar|2 sided McNemar||Null hypothesis: there is no difference in the proportion of subjects who were pain free when treating early, as compared to treating late.||||0.289
71755462|NCT00335777|143013603|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|2 sided McNemar test||||||1|||||||McNemar|2 sided McNemar test||Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.||||1.000
71755463|NCT00124943|143013618|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.396
71755464|NCT00124943|143013619|SUPERIORITY_OR_OTHER|||||||0.783||95.0|||||Fisher Exact|||Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.||||0.783
71755465|NCT00124943|143013620|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||Fisher Exact|||Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.||||0.293
71755466|NCT00124943|143013620|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposes||||0.400
71755467|NCT00124943|143013621|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||>0.999
71755468|NCT00124943|143013622|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.||||0.061
71755469|NCT00124943|143013623|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Fisher Exact|||Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.709
71755470|NCT00124943|143013623|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Fisher Exact|||Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.||||0.495
71755471|NCT00124943|143013624|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||ANOVA|P-value testing dose group differences based on an analysis of variance with dose effect in the model.||||||0.317
71755472|NCT01887327|143013632|OTHER||LS Mean Difference vs Placebo|-31.64|||=|2.1e-06|TWO_SIDED|95.0|-44.0|-19.283|||LS Mean Difference vs Placebo|||||-19.283|-44.000|=0.0000021
71755473|NCT01887327|143013632|OTHER||LS Mean Difference vs Placebo|-27.4|||=|2.6e-05|TWO_SIDED|95.0|-39.657|-15.142|||LS Mean Difference vs Placebo|||||-15.142|-39.657|=0.0000260
71671126|NCT03349060|142860118|SUPERIORITY||Difference in Percentage|12.5||||0.1138|TWO_SIDED|95.0|-3.0|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||28.0|-3.0|0.1138
71671127|NCT03349060|142860118|SUPERIORITY||Difference in Percentage|41.8|||<|0.0001|TWO_SIDED|95.0|26.2|57.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||57.4|26.2|<0.0001
71671128|NCT03349060|142860118|SUPERIORITY||Difference in Percentage|28.7|||<|0.0001|TWO_SIDED|95.0|15.3|42.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||42.1|15.3|<0.0001
71671129|NCT03349060|142860118|SUPERIORITY||Difference in Percentage|47.8|||<|0.0001|TWO_SIDED|95.0|34.6|61.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.||61.1|34.6|<0.0001
71755474|NCT03027609|143013636|SUPERIORITY|comparison between the treatment and placebo|Risk Difference (RD)|-5.54||||0.6154|TWO_SIDED|95.0|-21.9|10.8||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||10.8|-21.9|0.6154
71755475|NCT03027609|143013637|SUPERIORITY||Risk Difference (RD)|4.01||||0.8426|TWO_SIDED|95.0|-18.5|10.5||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||10.5|-18.5|0.8426
71755476|NCT03027609|143013638|SUPERIORITY|comparison between the treatment and placebo|P value CMH|3.6||||0.3562|TWO_SIDED|95.0|-13.1|20.3||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||Comparison between the treatment and placebo||20.3|-13.1|0.3562
71755477|NCT03027609|143013639|SUPERIORITY|Comparison between the treatment and placebo|P value CMH|-2.81||||0.8472|TWO_SIDED|95.0|-18.9|13.2||P-value was obtained with the stratified CMH test adjusted for baseline randomization strata|Cochran-Mantel-Haenszel|||||13.2|-18.9|0.8472
71755478|NCT03027609|143013640|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4616|TWO_SIDED|95.0|-16.2|60.6||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||60.6|-16.2|0.4616
71755479|NCT03027609|143013640|SUPERIORITY||Mean Difference (Final Values)|22.3||||0.4053|TWO_SIDED|95.0|-13.3|57.8||Data for Day 21|Chi-squared|||Data for Day 21||57.8|-13.3|0.4053
71755480|NCT03027609|143013641|SUPERIORITY||Mean Difference (Final Values)|38.1||||0.0833|TWO_SIDED|90.0|-14.8|90.9||Marginally statistically significant only if p\<0.1|Chi-squared|||Data for Day 14||90.9|-14.8|0.0833
71755481|NCT03027609|143013641|SUPERIORITY||Mean Difference (Net)|23.8||||0.5151|TWO_SIDED|90.0|-30.5|78.1||Data for Day 21|Chi-squared|Marginally statistically significant only if p\<0.1 Day 21||Data for Day 21||78.1|-30.5|0.5151
71755482|NCT01462370|143013646|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority margin is -3.7 units.|Difference in LS Means|0.89||||0.043|TWO_SIDED|95.0|0.03|1.76||A priori threshold for statistical significance = \<0.025 (one-sided).|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.||1.76|0.03|0.043
71755483|NCT01462370|143013647|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.2||||0.768|TWO_SIDED|95.0|-1.16|1.57||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||1.57|-1.16|0.768
71755484|NCT01462370|143013648|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.007|TWO_SIDED|95.0|0.07|0.45||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.07|0.007
71755485|NCT01462370|143013649|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.36|||<|0.001|TWO_SIDED|95.0|0.17|0.54||A nominal threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.54|0.17|<0.001
71787986|NCT03235154|143073466|OTHER|There was no comparator arm in this small single arm study||||||||||||No confidence intervals around point estimates provided given very small number of participants||||This was a single arm intervention study with a very small number of participants. Therefore, only descriptive statistics are provided.|No confidence intervals around point estimates provided given very small number of participants|||
71787987|NCT02326025|143073467|SUPERIORITY||Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.964|1.13|||||Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.|||1.13|0.964|
71787988|NCT02326025|143073467|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.957|1.11||||||||1.11|0.957|
71787989|NCT02326025|143073468|SUPERIORITY||Ratio of LS Means|0.944|||||TWO_SIDED|90.0|0.77|1.16||||||||1.16|0.770|
71787990|NCT02326025|143073468|SUPERIORITY||Ratio of LS Means|1.03|||||TWO_SIDED|90.0|0.801|1.33||||||||1.33|0.801|
71787991|NCT00001723|143073475|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|||||||0.007
71787992|NCT02643082|143073480|SUPERIORITY||LS Mean ratio between treatments|1.75|||<|0.0001|TWO_SIDED|95.0|1.65|1.86|||Mixed Models Analysis|||||1.86|1.65|<0.0001
71787993|NCT02643082|143073481|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.26|0.33|||Mixed Models Analysis|||||0.33|0.26|<0.0001
71787994|NCT02643082|143073482|SUPERIORITY||LS Mean ratio between treatments|0.29|||<|0.0001|TWO_SIDED|95.0|0.25|0.33|||Mixed Models Analysis|||||0.33|0.25|<0.0001
71787995|NCT02643082|143073483|SUPERIORITY||LS Mean ratio between treatments|1.79|||<|0.0001|TWO_SIDED|95.0|1.67|1.92|||Mixed Models Analysis|||||1.92|1.67|<0.0001
71755486|NCT01462370|143013650|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.371|TWO_SIDED|95.0|0.7|1.14||A priori threshold for statistical significance = \<0.05.|Regression, Cox|Adjusted for treatment, period, and baseline pain intensity.||||1.14|0.70|0.371
71755487|NCT01462370|143013651|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.051|TWO_SIDED|95.0|0.0|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|-0.00|0.051
71755488|NCT01462370|143013652|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference in LS Means|0.17||||0.019|TWO_SIDED|95.0|0.03|0.32||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.32|0.03|0.019
71755489|NCT01462370|143013654|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.31||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.31|0.10|<0.001
71755490|NCT01462370|143013655|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.28||||0.002|TWO_SIDED|95.0|0.1|0.45||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.45|0.10|0.002
71671130|NCT03349060|142860119|SUPERIORITY||Difference in least squares (LS) mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.4|<0.0001
71671131|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-2.0|<0.0001
71755491|NCT01462370|143013656|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.11||||0.011|TWO_SIDED|95.0|0.03|0.2||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.20|0.03|0.011
71755492|NCT01462370|143013657|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.26||||0.004|TWO_SIDED|95.0|0.08|0.44||A priori threshold for statistical significance = \<0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||||0.44|0.08|0.004
71755493|NCT01462370|143013658|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.112|TWO_SIDED|95.0|0.9|2.87||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||2.87|0.90|0.112
71755494|NCT01462370|143013659|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.019|TWO_SIDED|95.0|1.12|3.45||A priori threshold for statistical significance = \<0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.||||3.45|1.12|0.019
71755495|NCT02220920|143013660|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.33|-0.87|||ANCOVA|||||-0.87|-1.33|<0.001
71755496|NCT02220920|143013661|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-32.6|STANDARD_ERROR_OF_MEAN|6.9|<|0.001|TWO_SIDED|95.0|-46.3|-18.9|||ANCOVA|||||-18.9|-46.3|<0.001
71671132|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.6|<0.0001
71755497|NCT02220920|143013662|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.37|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.09|-1.65|||ANCOVA|||||-1.65|-3.09|<0.001
71755498|NCT02220920|143013663|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.19|STANDARD_ERROR_OF_MEAN|1.67||0.058|TWO_SIDED|95.0|-6.49|0.11|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.|||0.11|-6.49|0.058
71755499|NCT02220920|143013663|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|1.03||0.232|TWO_SIDED|95.0|-3.27|0.8|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.|||0.80|-3.27|0.232
71755500|NCT04723056|143013667|OTHER|||||||0.282||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.282
71755501|NCT04723056|143013668|OTHER|||||||0.217||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.217
71755502|NCT04723056|143013669|OTHER|||||||0.462||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||0.462
71755503|NCT04723056|143013669|OTHER|||||||0.179||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||0.179
71755504|NCT04723056|143013670|OTHER|||||||0.573||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.573
71755505|NCT04723056|143013670|OTHER|||||||0.606||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.606
71755506|NCT04723056|143013671|OTHER|||||||0.181||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.181
71755507|NCT04723056|143013672|OTHER|||||||0.407||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.407
71755508|NCT04723056|143013673|OTHER|||||||0.643||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.643
71755509|NCT04723056|143013674|OTHER|||||||0.625||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 8||||.625
71755510|NCT04723056|143013674|OTHER|||||||0.707||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||Between-group analysis at week 24||||.707
71787996|NCT02643082|143073484|SUPERIORITY||LS Mean Difference Between Treatments|0.443|||<|0.0001|TWO_SIDED|95.0|0.318|0.569|||Mixed Models Analysis|||||0.569|0.318|<0.0001
71755511|NCT04196777|143013714|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 3. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.089||||0.004|TWO_SIDED|95.0|0.016|0.445|||Regression, Logistic|||To model the primary outcome for site 3, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||0.445|0.016|0.004
71755512|NCT04196777|143013714|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 1. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|1.593||||0.259|TWO_SIDED|95.0|0.71|3.585|||Regression, Logistic|||To model the primary outcome for site 1, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||3.585|0.710|0.259
71755513|NCT04196777|143013714|OTHER|We performed a logistic regression analysis that measured the effect of the intervention at site 2. The below results show the interaction term between time and the intervention from this model. Time was measured in days divided by 365, giving an annualized figure for the time coefficient estimate and interaction coefficient.|Odds Ratio (OR)|0.748||||0.738|TWO_SIDED|95.0|0.135|4.147|||Regression, Logistic|||To model the primary outcome for site 2, we used a logistic regression model and a set of three explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, and an interaction term between these two main effects (time and intervention).||4.147|0.135|0.738
71755514|NCT04196777|143013715|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 3 between the baseline and intervention periods.|Rank sum test statistic|1280.5||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 3 were compared using the Wilcoxon rank-sum test.||||0.001
71755515|NCT04196777|143013715|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 1 between the baseline and intervention periods.|Rank sum test statistic|28662.0||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 1 were compared using the Wilcoxon rank-sum test.Type of statistical test||||0.013
71755516|NCT04196777|143013715|OTHER|The Wilcoxon rank-sum test assessed whether the post-procedural antimicrobial duration significantly differed at site 2 between the baseline and intervention periods.|Rank sum test statistic|784.0||||0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The median duration of post-procedural antimicrobial prescriptions at site 2 were compared using the Wilcoxon rank-sum test.||||0.14
71755517|NCT04196777|143013716|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.76||||0.04|TWO_SIDED|95.0|0.58|0.99|||Regression, Logistic|||To model this secondary outcome, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome. This last variable was included to assess the risk of these secondary outcomes in patients who were not exposed to post-procedural antimicrobials compared to those who were exposed.||0.99|0.58|0.04
71755518|NCT04196777|143013717|OTHER|We performed a logistic regression model that included patients across all 3 sites.|Odds Ratio (OR)|0.68|||<|0.01|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||To model this secondary outcome across all sites, we used a logistic regression model and a set of four explanatory variables: time, a binary indicator for an observation occurring within the intervention phase, an interaction term between these two main effects (time and intervention), and a binary indicator for the primary outcome.||0.87|0.53|<0.01
71671133|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-2.8|<0.0001
71755519|NCT00981656|143013724|OTHER|No testing is done, conclusions are made based on the confidence interval.||||||||||||||||Null hypothesis = this treatment will result in 75% of participants free from radical cystectomy at 3 years. A lower confidence bound of 60% will be promising enough to pursue this regimen further. A sample size of 33 analyzable patients provides a one-sided 97.5% lower bound of 60% relative to the hypothesized 75%. In terms of type I error, this design provides a 2.5% chance of observing a 3-year percentage less than 60% if the true rate is 75%.|If the lower confidence interval (CI) limit was above 60% then the regimen would be considered promising enough to warrant further study for this treatment regimen. If the lower limit was below 25% then the treatment would not be considered worthy of further study. If the lower limit fell between 25% and 60%, the investigators would consider the possibility of further investigation.|||
71755520|NCT00837434|143013785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED||||||ANCOVA|P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory||Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.||||0.3
71755521|NCT01122238|143013792|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.665
71787997|NCT02643082|143073485|SUPERIORITY||LS Mean ratio between treatments|0.87|||<|0.0001|TWO_SIDED|95.0|0.82|0.92|||Mixed Models Analysis|||||0.92|0.82|<0.0001
71787998|NCT01324999|143073486|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing baseline to week 24.||||0.68
71755522|NCT01122238|143013792|SUPERIORITY_OR_OTHER|||||||0.562|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.562
71755523|NCT01122238|143013792|SUPERIORITY_OR_OTHER|||||||0.536|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.536
71755524|NCT01122238|143013792|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.||||.206
71755525|NCT01122238|143013793|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.98|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.98
71755526|NCT01122238|143013793|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.4|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.40
71755527|NCT01122238|143013793|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|0.0||||0.99|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.99
71755528|NCT01122238|143013793|SUPERIORITY_OR_OTHER||Standardized Regression Coefficient|-0.04||||0.33|TWO_SIDED||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.||||.33
71755529|NCT02121158|143013815|EQUIVALENCE|Unadjusted|Hazard Ratio (HR)|0.915||||0.7457|TWO_SIDED|95.0|0.534|1.568|||Cox Proportional Hazards|||||1.568|0.534|0.7457
71755530|NCT03367793|143013897|OTHER||f statistic|1.1||||0.341|TWO_SIDED|||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.341
71755531|NCT03367793|143013897|OTHER||least square means|0.31|||||TWO_SIDED|95.0|0.26|0.36|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.36|0.26|
71671134|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-0.9||||0.0035|TWO_SIDED|95.0|-1.5|-0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.5|0.0035
71755532|NCT03367793|143013897|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.27|0.38|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.38|0.27|
71755533|NCT03367793|143013897|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.39|||||Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.39|0.28|
71755534|NCT03367793|143013898|OTHER||f statistic|0.93||||0.41|TWO_SIDED|||||The threshold for statistical significance was 0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.410
71755535|NCT03367793|143013898|OTHER||least square means|0.35|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST.|||0.41|0.28|
71755536|NCT03367793|143013898|OTHER||least square means|0.33|||||TWO_SIDED|95.0|0.26|0.39|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX.|||0.39|0.26|
71755537|NCT03367793|143013898|OTHER||least square means|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.|||0.41|0.28|
71755538|NCT03367793|143013899|OTHER||f statistic|1.09||||0.351|TWO_SIDED|||||The threshold for statistical significance was alpha=0.05.|f test|||It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.||||0.351
71755539|NCT03367793|143013899|OTHER||least square means|11.0|||||TWO_SIDED|95.0|9.3|12.7|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST.|||12.7|9.3|
71755540|NCT03367793|143013899|OTHER||least square means|10.9|||||TWO_SIDED|95.0|9.2|12.6|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX.|||12.6|9.2|
71787999|NCT01324999|143073487|OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
71788000|NCT01324999|143073488|OTHER|||||||0.99|||||||t-test, 2 sided|||||||0.99
71755541|NCT03367793|143013899|OTHER||least square means|11.2|||||TWO_SIDED|95.0|9.5|12.9|||||Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction.|||12.9|9.5|
71755542|NCT03367793|143013900|OTHER||f statistic|0.58||||0.562|TWO_SIDED||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||0.562
71755543|NCT03367793|143013900|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST.|||||
71755544|NCT03367793|143013900|OTHER||proportion|0.933|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX.|||||
71755545|NCT03367793|143013900|OTHER||proportion|0.897|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction.|||||
71755546|NCT03367793|143013901|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
71755547|NCT03367793|143013901|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST.|||||
71755548|NCT03367793|143013901|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX.|||||
71755549|NCT03367793|143013901|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction.|||||
71755550|NCT03367793|143013902|OTHER||||||>|0.99|||||||Mixed Models Analysis|||It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).||||>0.99
71755551|NCT03367793|143013902|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST.|||||
71755552|NCT03367793|143013902|OTHER||proportion|0.967|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX.|||||
71755553|NCT03367793|143013902|OTHER||proportion|0.966|||||TWO_SIDED||||||||Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction.|||||
71755554|NCT02224560|143013915|SUPERIORITY||Median Difference (Final Values)|-21.57||||0.0047|TWO_SIDED|95.0|-34.79|-6.67|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-6.67|-34.79|0.0047
71755555|NCT02224560|143013915|SUPERIORITY||Median Difference (Final Values)|-19.19||||0.0016|TWO_SIDED|95.0|-31.24|-7.69|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.69|-31.24|0.0016
71755556|NCT02224560|143013916|SUPERIORITY||Odds Ratio (OR)|3.85||||0.0006|TWO_SIDED|95.0|1.75|8.47||Calculated using a Cochran-Mantel-Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||8.47|1.75|0.0006
71755557|NCT02224560|143013916|SUPERIORITY||Odds Ratio (OR)|3.27||||0.003|TWO_SIDED|95.0|1.47|7.26||Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel|||||7.26|1.47|0.0030
71788001|NCT01324999|143073489|OTHER|||||||0.19|||||||t-test, 2 sided|||comparing baseline to week 24||||0.19
71788002|NCT01324999|143073490|OTHER|||||||0.68|||||||t-test, 2 sided|||Comparing Baseline to week 24.||||0.68
71755558|NCT02224560|143013917|SUPERIORITY||Median Difference (Final Values)|-18.76||||0.0091|TWO_SIDED|95.0|-31.8|-4.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.43|-31.80|0.0091
71755559|NCT02224560|143013917|SUPERIORITY||Median Difference (Final Values)|-19.47||||0.0015|TWO_SIDED|95.0|-30.37|-7.47|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-7.47|-30.37|0.0015
71755560|NCT02224560|143013918|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0439|TWO_SIDED|95.0|1.02|3.3|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||3.30|1.02|0.0439
71755561|NCT02224560|143013918|SUPERIORITY||Odds Ratio (OR)|2.57||||0.002|TWO_SIDED|95.0|1.41|4.66|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale|||4.66|1.41|0.0020
71755562|NCT03165617|143013919|SUPERIORITY|Success criterion were met as the LL of the 2-sided 95% CI was above 20%.|Absolute Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical Analysis title - Absolute Vaccine Efficacy Any Strain. Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 20% (primary endpoint) using the protocol definition of ILI for the entire age range (2 to \<18 years of age).||62.12|45.67|
71755563|NCT03165617|143013920|SUPERIORITY|Success criteria was met as the LL of the 2-sided 95% CI of the VE estimate was greater than 30% (co-primary endpoint)|Absolute Vaccine Efficacy|54.03|||||TWO_SIDED|95.0|44.8|61.71||||||Statistical analysis title - Absolute Vaccine Efficacy, Any Strain Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 30% (co-primary endpoint) using the protocol definition of ILI for the entire age range (≥ 3 to \<18 years of age).||61.71|44.8|
71755564|NCT03165617|143013921|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
71755565|NCT03165617|143013921|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|50.51|||||TWO_SIDED|95.0|38.43|60.22||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||60.22|38.43|
71788003|NCT01324999|143073491|OTHER|||||||0.92|||||||t-test, 2 sided|||comparing baseline to week 24||||0.92
71755566|NCT03165617|143013921|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|53.33|||||TWO_SIDED|95.0|43.38|61.54||||||Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||61.54|43.38|
71755567|NCT03165617|143013921|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.85|||||TWO_SIDED|95.0|47.37|72.34||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||72.34|47.37|
71755568|NCT03165617|143013922|SUPERIORITY|Absolute Vaccine Efficacy (aVE) for 2 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints|Absolute Vaccine Efficacy|54.63|||||TWO_SIDED|95.0|45.67|62.12||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||62.12|45.67|
71755569|NCT03165617|143013922|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
71755570|NCT03165617|143013922|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||68.05|49.08|
71755571|NCT03165617|143013922|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
71755572|NCT03165617|143013923|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.81|||||TWO_SIDED|95.0|51.3|68.46||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||68.46|51.3|
71755573|NCT03165617|143013923|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.78|||||TWO_SIDED|95.0|49.01|69.83||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||69.83|49.01|
71788004|NCT01324999|143073492|OTHER|||||||0.44|||||||t-test, 2 sided|||comparison of baseline to week 24||||0.44
71788005|NCT01317160|143073585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Chi-squared|||Domeij-Arverud et al., Bone Joint J 2015;97-B:675-80.||||0.042
71788006|NCT01317160|143073585|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.81|||<|0.05|TWO_SIDED|95.0|1.25|6.32|||Regression, Logistic|Age was adjusted for in the calculation.|Risk of VTE by routine care (numerator) divided by IPC treatment (denominator)|||6.32|1.25|<0.05
71788007|NCT01317160|143073587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.737|TWO_SIDED||||||Chi-squared|||||||0.737
71755574|NCT03165617|143013923|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|59.66|||||TWO_SIDED|95.0|49.08|68.05||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||68.05|49.08|
71755575|NCT03165617|143013923|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|60.72|||||TWO_SIDED|95.0|42.14|73.33||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||73.33|42.14|
71755576|NCT03165617|143013924|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.64|||||TWO_SIDED|95.0|53.64|71.48||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<18yrs||71.48|53.64|
71755577|NCT03165617|143013924|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 2 to \<9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|63.04|||||TWO_SIDED|95.0|50.66|72.32||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to \<9yrs||72.32|50.66|
71755578|NCT03165617|143013924|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 4 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|61.58|||||TWO_SIDED|95.0|50.25|70.53||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to \<18yrs||70.53|50.25|
71755579|NCT03165617|143013924|SUPERIORITY|"Statistical analysis description:~Absolute Vaccine Efficacy (aVE) for 9 to \<18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints"|Absolute Vaccine Efficacy|64.78|||||TWO_SIDED|95.0|44.84|77.51||||||Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to \<18yrs||77.51|44.84|
71755580|NCT03279081|143013959|SUPERIORITY||Difference in Combined Remission Rate|2.37|||=|0.571|TWO_SIDED|95.0|-5.82|10.55||P-value was based on stratified Cochran-Mantel-Haenszel (CMH) test adjusting for interactive web response system (IWRS) randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals (CI) are displayed.|||10.55|-5.82|=0.571
71755581|NCT03279081|143013960|SUPERIORITY||Difference in Clinical Remission Rate|2.72|||=|0.515|TWO_SIDED|95.0|-5.47|10.9||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||10.90|-5.47|=0.515
71788008|NCT02715076|143073610|OTHER||||||<|0.05|||||||mixed-effects model|||||||<0.05
71788009|NCT02771990|143073633|OTHER|Pilot study|z-score|3.11||||0.002|TWO_SIDED||||||Regression, Linear|||||||0.002
71788010|NCT02771990|143073634|OTHER|Pilot study||||||0.67|||||||Regression, Linear|||||||0.67
71788011|NCT00848081|143073635|SUPERIORITY_OR_OTHER|||||||0.403||||||1-sided test|Fisher Exact|||The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.||||0.403
71755582|NCT03279081|143013961|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.374|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate the hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.374
71755583|NCT03279081|143013962|SUPERIORITY||Difference in Combined Remission Rate|1.27|||=|0.757|TWO_SIDED|95.0|-6.77|9.31||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.31|-6.77|=0.757
71892109|NCT00824564|143305799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.57||0.109|TWO_SIDED|95.0|-20.7|2.2|||t-test, 2 sided|||For 1 hour post-surgery, the mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||2.2|-20.7|0.109
71892110|NCT00824564|143305799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.24||0.045|TWO_SIDED|95.0|-13.4|-0.1|||t-test, 2 sided|||For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||-0.1|-13.4|0.045
71671135|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.3|-2.5|<0.0001
71755584|NCT03279081|143013963|SUPERIORITY||Difference in Clinical Remission Rate|1.6|||=|0.697|TWO_SIDED|95.0|-6.46|9.66||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||9.66|-6.46|=0.697
71755585|NCT03279081|143013964|SUPERIORITY||Difference in Clinical Response Rate|3.23|||=|0.428|TWO_SIDED|95.0|-4.76|11.21||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.21|-4.76|=0.428
71755586|NCT03279081|143013965|SUPERIORITY||Difference in Clinical Response Rate|2.84|||=|0.497|TWO_SIDED|95.0|-5.35|11.03||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||11.03|-5.35|=0.497
71755587|NCT03279081|143013966|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.363|TWO_SIDED|95.0|0.9|1.32||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.32|0.90|=0.363
71755588|NCT03279081|143013967|SUPERIORITY||Hazard Ratio (HR)|0.98|||=|0.833|TWO_SIDED|95.0|0.82|1.18||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.18|0.82|=0.833
71788012|NCT00848081|143073637|SUPERIORITY_OR_OTHER|||||||0.13||||||p-value is on change from baseline|ANCOVA|||The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.||||0.130
71788013|NCT00848081|143073638|SUPERIORITY_OR_OTHER|||||||0.258||||||p-value is on change from baseline|ANOVA|The p-value is from Type III sums of squares ANOVA on rank-transformed data.||||||0.258
71892111|NCT00824564|143305799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|4.2||0.119|TWO_SIDED|95.0|-15.4|1.8|||t-test, 2 sided|||For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||1.8|-15.4|0.119
71755589|NCT03279081|143013968|SUPERIORITY||Hazard Ratio (HR)|0.97|||=|0.717|TWO_SIDED|95.0|0.81|1.16||P-value was based on a stratified log-rank test adjusting for IWRS randomization stratification factors.|Log Rank||Cox Proportional Hazard Regression model was used to estimate hazard ratio and 95% CI, adjusting for IWRS randomization stratification factors.|||1.16|0.81|=0.717
71788014|NCT00848081|143073639|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.||||||0.828
71755590|NCT03279081|143013969|SUPERIORITY||Difference in Relapse Rate|3.03|||=|0.599|TWO_SIDED|95.0|-8.28|14.34||P-value was based on stratified CMH test adjusting for IWRS randomization stratification factors.|Cochran-Mantel-Haenszel||The asymptotic Wald's confidence intervals are displayed.|||14.34|-8.28|=0.599
71788015|NCT02064868|143073640|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0172|TWO_SIDED|95.0|0.51|0.98||One-sided p-value|Gehan's generalized Wilcoxon test|||||0.98|0.51|0.0172
71788016|NCT02064868|143073641|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0634|TWO_SIDED|95.0|0.61|1.02||Two-sided p-value|Gehan's generalized Wilcoxon test|||||1.02|0.61|0.0634
71788017|NCT02064868|143073642|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71788018|NCT02064868|143073643|SUPERIORITY|||||||0.0002|||||||Chi-squared|||||||0.0002
71755591|NCT01710345|143013987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|4.45||0.742|ONE_SIDED|95.0|||||ANCOVA|||||||0.742
71755592|NCT01710345|143013987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.66|STANDARD_ERROR_OF_MEAN|4.47||0.003|ONE_SIDED|95.0|||||ANCOVA|||||||0.003
71755593|NCT02105740|143014023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|STANDARD_DEVIATION|1.178||0.034|TWO_SIDED|95.0|0.224|5.11|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.||5.110|0.224|0.034
71788019|NCT02064868|143073644|SUPERIORITY|||||||0.1392|||||||Wilcoxon (Mann-Whitney)|||||||0.1392
71788020|NCT02064868|143073646|SUPERIORITY|||||||0.3115|||||||Mixed Models Analysis|||Day 5||||0.3115
71788021|NCT02064868|143073646|SUPERIORITY|||||||0.1236|||||||Mixed Models Analysis|||Day 14||||0.1236
71755594|NCT02105740|143014023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.66|STANDARD_DEVIATION|0.856||0.004|TWO_SIDED|95.0|1.253|6.08|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.||6.080|1.253|0.004
71755595|NCT02105740|143014023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.25|STANDARD_DEVIATION|0.827||0|TWO_SIDED|95.0|2.918|7.582|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.||7.582|2.918|0.000
71755596|NCT02105740|143014024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.||||
71755597|NCT02105740|143014024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|||||||||Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.||||
71755598|NCT05810740|143014078|OTHER||LS-Mean Ratio, Percent|96.43|||||TWO_SIDED|90.0|92.57|100.46||||||||100.46|92.57|
71755599|NCT05810740|143014079|OTHER||Geometric Mean Ratio|97.19|||||TWO_SIDED|90.0|93.47|101.06||||||||101.06|93.47|
71755600|NCT05810740|143014080|OTHER||Geometric Mean Ratio|94.02|||||TWO_SIDED|90.0|87.25|101.33||||||||101.33|87.25|
71755601|NCT05452486|143014110|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|-3.89|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Dichotic digits comparison||||<0.01
71755602|NCT05452486|143014110|EQUIVALENCE|The purpose of this study was to evaluate whether the mean performance on auditory processing assessments differed depending on whether the tests were administered in Spanish or English.|Slope|5.18||||0.69|TWO_SIDED||||||Mixed Models Analysis|||Dichotic words comparison||||0.69
71755603|NCT00107653|143014111|SUPERIORITY_OR_OTHER||SVR for Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08||P-values are calculated based on the difference in proportion between Latino and Non-Latino White group|Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.|SVR for Latino Versus (VS) Non-Latino White||-0.08|-0.24|<0.0001
71755604|NCT00107653|143014112|SUPERIORITY_OR_OTHER||Study Group Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.031||0.0454|TWO_SIDED|95.0|-0.12|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.00|-0.12|0.0454
71755605|NCT00107653|143014112|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.07|-0.23|0.0003
71788022|NCT00711711|143073647|SUPERIORITY_OR_OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.51
71755606|NCT00107653|143014112|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.039||0.0004|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 24||-0.06|-0.22|0.0004
71755607|NCT00107653|143014112|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 48||-0.09|-0.24|<0.0001
71755608|NCT00107653|143014112|SUPERIORITY_OR_OTHER||Study Group Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.25|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 60||-0.09|-0.25|<0.0001
71755609|NCT00107653|143014112|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 72||-0.08|-0.24|<0.0001
71755610|NCT00107653|143014113|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.036||0.0353|TWO_SIDED|95.0|-0.15|-0.01|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4||-0.01|-0.15|0.0353
71755611|NCT00107653|143014114|SUPERIORITY_OR_OTHER||Study Group Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.033||0.0014|TWO_SIDED|95.0|-0.17|-0.04|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12||-0.04|-0.17|0.0014
71755612|NCT00107653|143014116|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0006|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 4||-0.06|-0.22|0.0006
71892112|NCT00824564|143305799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|15.16||0.139|TWO_SIDED|95.0|-52.9|7.5|||t-test, 2 sided|||For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||7.5|-52.9|0.139
71892113|NCT00824564|143305800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.2|STANDARD_ERROR_OF_MEAN|132.1||0.849|TWO_SIDED|95.0|-238.2|288.6|||t-test, 2 sided|||The mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.||288.6|-238.2|0.849
71755613|NCT00107653|143014116|SUPERIORITY_OR_OTHER||Study Group Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 12||-0.08|-0.24|<0.0001
71892114|NCT00824564|143305801|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||Chi-square test was used at 5% level of significance.||||0.714
71755614|NCT00107653|143014116|SUPERIORITY_OR_OTHER||Study Group Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003|TWO_SIDED|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 24||-0.07|-0.23|0.0003
71755615|NCT00107653|143014116|SUPERIORITY_OR_OTHER||Study Group Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.042||0.0008|TWO_SIDED|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 48||-0.06|-0.22|0.0008
71788023|NCT00711711|143073648|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P\<.05.||||0.58
71892115|NCT00824564|143305802|SUPERIORITY_OR_OTHER||Least square means difference|0.37|STANDARD_ERROR_OF_MEAN|0.295||0.208|TWO_SIDED|95.0|-0.21|0.96|||Mixed Models Analysis|||For change at end of surgery, a Mixed Model Repeated Measures (MMRM) approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.96|-0.21|0.208
71755616|NCT00107653|143014116|SUPERIORITY_OR_OTHER||Study Group Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.26|-0.1|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 60||-0.10|-0.26|<0.0001
71755617|NCT00107653|143014116|SUPERIORITY_OR_OTHER||Study Group Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.27|-0.11|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 72||-0.11|-0.27|<0.0001
71755618|NCT00107653|143014117|SUPERIORITY_OR_OTHER||Study Group Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0285|TWO_SIDED|95.0|-0.2|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with ISHAK HAI response. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI Response For Latino VS Non-Latino White||-0.0|-0.2|0.0285
71892116|NCT00824564|143305802|SUPERIORITY_OR_OTHER||Least square means difference|0.1|STANDARD_ERROR_OF_MEAN|0.255||0.682|TWO_SIDED|95.0|-0.4|0.61|||Mixed Models Analysis|||For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.61|-0.40|0.682
71788024|NCT00754624|143073668|SUPERIORITY_OR_OTHER||Slope|-0.048|||||TWO_SIDED|95.0|-0.059|-0.037|||Random coefficient|Adjusted for Baseline FEV1 value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FEV1 data to estimate the annual rate of decline. The model included terms for baseline FEV1 and time (in years) of FEV1 measurements. Missing pulmonary functions were not imputed.||-0.037|-0.059|
71892117|NCT00824564|143305802|SUPERIORITY_OR_OTHER||Least square means difference|0.14|STANDARD_ERROR_OF_MEAN|0.244||0.569|TWO_SIDED|95.0|-0.35|0.63|||Mixed Models Analysis|||For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.63|-0.35|0.569
71892118|NCT00824564|143305802|SUPERIORITY_OR_OTHER||Least square means difference|0.2|STANDARD_ERROR_OF_MEAN|0.249||0.413|TWO_SIDED|95.0|-0.29|0.7|||Mixed Models Analysis|||For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.70|-0.29|0.413
71755619|NCT00107653|143014118|SUPERIORITY_OR_OTHER||Study Group Difference|0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.5|1.3|||Normal approximation to the binomial.||The estimated value is the difference in change from baseline of ISHAK HAI activity (necroinflammatory) scores between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI activity For Latino VS Non-Latino White||1.3|0.5|<0.0001
71755620|NCT00107653|143014127|SUPERIORITY_OR_OTHER||Study Group Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|95.0|-0.96|-0.33|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 48||-0.33|-0.96|<0.0001
71755621|NCT00107653|143014127|SUPERIORITY_OR_OTHER||Study Group Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.156||0.0921|TWO_SIDED|95.0|-0.57|0.04|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 72||0.04|-0.57|0.0921
71755622|NCT00107653|143014127|SUPERIORITY_OR_OTHER||Study Group Difference|-8.72|STANDARD_ERROR_OF_MEAN|2.725||0.0015|TWO_SIDED|95.0|-14.07|-3.36|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 48 between Latino and Non-Latino White participants The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 48||-3.36|-14.07|0.0015
71755623|NCT00107653|143014127|SUPERIORITY_OR_OTHER||Study Group Difference|4.83|STANDARD_ERROR_OF_MEAN|2.37||0.0421|TWO_SIDED|95.0|0.18|9.49|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 72||9.49|0.18|0.0421
71755624|NCT00107653|143014128|SUPERIORITY_OR_OTHER||Study Group Difference|3.49|STANDARD_ERROR_OF_MEAN|0.864|<|0.0001|TWO_SIDED|95.0|1.79|5.18|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 48||5.18|1.79|<0.0001
71755625|NCT00107653|143014128|SUPERIORITY_OR_OTHER||Study Group Difference|0.1|STANDARD_ERROR_OF_MEAN|0.808||0.9047|TWO_SIDED|95.0|-1.49|1.68|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 72||1.68|-1.49|0.9047
71755626|NCT00107653|143014128|SUPERIORITY_OR_OTHER||Study Group Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.914||0.9286|TWO_SIDED|95.0|-1.88|1.71|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 48||1.71|-1.88|0.9286
71755627|NCT00107653|143014128|SUPERIORITY_OR_OTHER||Study Group Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1653|TWO_SIDED|95.0|-2.98|0.51|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 72||0.51|-2.98|0.1653
71755628|NCT04314284|143014162|SUPERIORITY|||||||0.15|||||||Kruskal-Wallis|||||||0.15
71755629|NCT04314284|143014163|SUPERIORITY|||||||0.35|||||||Kruskal-Wallis|||||||0.35
71755630|NCT04314284|143014164|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
71755631|NCT04314284|143014168|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
71755632|NCT04314284|143014169|SUPERIORITY|||||||0.52|||||||Kruskal-Wallis|||||||0.52
71892119|NCT00824564|143305802|SUPERIORITY_OR_OTHER||Least square means difference|0.11|STANDARD_ERROR_OF_MEAN|0.276||0.686|TWO_SIDED|95.0|-0.44|0.66|||Mixed Models Analysis|||For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.||0.66|-0.44|0.686
71892120|NCT00824564|143305803|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||Fisher Exact|||Fisher's exact test at 5% level of significance was used as the event rate was low and the expected count for any cell in the (unstratified) 2\*2 contingency table was less than 5.||||0.241
71755633|NCT04314284|143014170|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71755634|NCT04314284|143014173|OTHER|2-sided||||||0.71|||||||t-test, 2 sided|||||||0.71
71755635|NCT04314284|143014174|OTHER|2-sided||||||0.12|||||||t-test, 2 sided|||||||0.12
71755636|NCT04314284|143014176|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||0.66
71755637|NCT03829228|143014186|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.62|2.01||The threshold for statistical significance was p=0.01|ANOVA||Treatment Difference= Visit5-Baseline|||2.01|0.62|<0.0001
71755638|NCT03829228|143014187|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significance was p=0.01|Regression, Logistic|||||||<0.0001
71755639|NCT03829228|143014188|SUPERIORITY||Mean Difference (Net)|1.31|||<|0.0001|TWO_SIDED|95.0|0.64|1.98||The threshold for statistical significance was p=0.01|ANOVA||Treatment difference=Visit5-Baseline|||1.98|0.64|<0.0001
71755640|NCT03829228|143014189|SUPERIORITY||||||<|0.0001||||||The threshold for statistical significant was p=0.01.|Regression, Logistic|||||||<0.0001
71755641|NCT02844569|143014190|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71755642|NCT02844569|143014191|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71755643|NCT02844569|143014192|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71755644|NCT05106894|143014197|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-7.4|5.5||||||||5.5|-7.4|
71755645|NCT05106894|143014198|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Median Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-8.3|3.6||||||||3.6|-8.3|
71755646|NCT05106894|143014199|EQUIVALENCE|Adjusted difference between groups in composite scores calculated using an ordinary least squares linear regression model (with adjustments for sex of child, caregiver educational level, poverty score, birth weight and change in length for age Z score from 0 to 6 months).|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-5.6|2.1||||||||2.1|-5.6|
71671136|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-1.1||||0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0010
71671137|NCT03349060|142860119|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.7|<0.0001
71755647|NCT03137381|143014236|SUPERIORITY|||||||0.177|||||||Chi-squared|||||||0.177
71788025|NCT00754624|143073669|SUPERIORITY_OR_OTHER||Slope|-0.058|||||TWO_SIDED|95.0|-0.072|-0.043|||Random Coefficient|Adjusted for Baseline FVC value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FVC data to estimate the annual rate of decline. The model included terms for baseline FVC and time (in years) of FVC measurements. Missing pulmonary functions were not imputed.||-0.043|-0.072|
71788026|NCT00754624|143073670|SUPERIORITY_OR_OTHER||Slope|-0.311|||||TWO_SIDED|95.0|-0.454|-0.168|||Random Coefficient|Adjusted for Baseline DLCo value||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed DLco data to estimate the annual rate of decline. The model included terms for baseline DLco and time (in years) of DLco measurements. Missing pulmonary functions were not imputed.||-0.168|-0.454|
71788027|NCT00106392|143073678|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-Values were not adjusted.|Wilcoxon (Mann-Whitney)|||A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.||||0.111
71892121|NCT04178590|143305806|SUPERIORITY|||||||0.429||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.429
71755648|NCT03137381|143014236|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71755649|NCT03137381|143014236|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71671138|NCT03349060|142860120|SUPERIORITY||Difference in LS mean|-1.3||||0.0002|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0002
71755650|NCT01684917|143014238|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71755651|NCT01684917|143014238|SUPERIORITY||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71788028|NCT00106392|143073679|SUPERIORITY_OR_OTHER|||||||0.453||95.0|||||Fisher Exact|||||||0.453
71788029|NCT00106392|143073680|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.790
71788030|NCT00106392|143073681|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||Fisher Exact|||||||0.099
71755652|NCT01684917|143014239|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
71755653|NCT01684917|143014240|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
71788031|NCT00106392|143073682|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.575
71788032|NCT00106392|143073683|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.879
71813238|NCT03881696|143128886|SUPERIORITY||Odds Ratio (OR)|27.853|||<|1e-05|TWO_SIDED|95.0|9.1274|111.2144||The a priori threshold for statistical significance was p \< 0.0001 at the interim analysis OR p \< 0.05 at the final analysis. Gatekeeping and multiple testing strategies were performed to ensure the overall family-wise error rate was ≤ 5%.|Fisher Exact||The odds ratio (OR) represents the odds of success among subjects randomized to omalizumab (numerator) compared to the odds of success among subjects randomized to placebo (denominator, reference group).|The null hypothesis is that the odds of 'success' (defined as consumption of a single dose of ≥600 mg of peanut protein without dose-limiting symptoms during the DBPCFC at the end of Stage 1) in omalizumab and placebo for omalizumab arms are equal. Participants missing the blinded OFC to peanut at the end of Stage 1 will be considered a 'failure' for the primary efficacy endpoint.||111.2144|9.1274|<0.00001
71892122|NCT04178590|143305807|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892123|NCT04178590|143305808|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892124|NCT04178590|143305809|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892125|NCT04178590|143305810|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
71892126|NCT04178590|143305811|SUPERIORITY|||||||0.575||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.575
71892127|NCT04178590|143305812|SUPERIORITY|||||||0.249||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.249
71671139|NCT03349060|142860120|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.6|-3.0|<0.0001
71755654|NCT01684917|143014241|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71755655|NCT01684917|143014241|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71755656|NCT01684917|143014241|SUPERIORITY||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks||||<0.05
71755657|NCT01684917|143014243|SUPERIORITY|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."||||<0.05
71755658|NCT00459316|143014247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Two-sided p-value \<0.05 was specified as statistically significant a priori. There were no adjustments for multiple outcomes.|Fisher Exact|||The null hypothesis was that there would be no difference between CD4% strata.||||0.03
71755659|NCT00459316|143014248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||Two sided-p-value \<0.05 was specified as statistically significant a priori. No adjustment for multiple primary outcomes was made.|Fisher Exact|||The null hypothesis was that there were no differences between CD4% strata.||||0.01
71755660|NCT03044106|143014262|SUPERIORITY||Mean Difference (Final Values)|3.825|STANDARD_DEVIATION|3.308759||0.0068|TWO_SIDED|95.0|1.058809|6.591192|||t-test, 2 sided|||This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.||6.591192|1.058809|0.0068
71788033|NCT00589914|143073684|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-1.62|2.38||No p-value to report.|ANCOVA|ANCOVA model with factors treatment, country and baseline score. Weighted approach used to account for interim analysis for sample size re-estimation.||Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.||2.38|-1.62|
71788034|NCT00589914|143073685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.07|0.17||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||0.17|-0.07|
71788035|NCT00589914|143073686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-1.22|1.69||No P-values reported.|ANCOVA|||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.||1.69|-1.22|
71788036|NCT01737944|143073689|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A - SC injection with the Vibex MTX device and Treatment B - SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.24|||||TWO_SIDED|90.0|92.33|100.31||||||||100.31|92.33|
71788037|NCT01737944|143073689|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.28|||||TWO_SIDED|90.0|97.17|105.56||||||||105.56|97.17|
71788038|NCT01737944|143073690|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.22|||||TWO_SIDED|90.0|92.32|100.28||||||||100.28|92.32|
71788039|NCT01737944|143073690|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.14|||||TWO_SIDED|90.0|97.06|105.4||||||||105.40|97.06|
71788040|NCT01737944|143073691|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.76|||||TWO_SIDED|90.0|87.93|106.47||||||||106.47|87.93|
71788041|NCT01737944|143073691|NON_INFERIORITY_OR_EQUIVALENCE|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|89.79|||||TWO_SIDED|90.0|81.61|98.78||||||||98.78|81.61|
71788042|NCT00010374|143073757|OTHER|Performance goal of 35%|Exact two-sided binomial test|96.2|||<|0.001|TWO_SIDED|95.0|87.0|99.5|||Exact two-sided binomial test|||||99.5|87.0|<0.001
71788043|NCT02746874|143073792|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
71788044|NCT02746874|143073794|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||||||.978
71788045|NCT02746874|143073795|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||.371
71788046|NCT02746874|143073796|SUPERIORITY|||||||0.325|||||||t-test, 2 sided|||||||.325
71671140|NCT03349060|142860121|SUPERIORITY|||||||0.0071||||||P-value was controlled by randomization strata.|Log Rank|||||||0.0071
71671141|NCT03349060|142860121|SUPERIORITY||||||<|0.0001||||||P-value was controlled by randomization strata.|Log Rank|||||||<0.0001
71755661|NCT03044106|143014262|SUPERIORITY||Median Difference (Final Values)|1.0|STANDARD_DEVIATION|3.431784||0.2185|TWO_SIDED|95.0|-1.869044|3.869044|||t-test, 2 sided|||This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.||3.869044|-1.869044|0.2185
71755662|NCT03044106|143014262|SUPERIORITY||Mean Difference (Final Values)|0.6638904|STANDARD_DEVIATION|3.450892||0.1281|TWO_SIDED|95.0|-0.5037233|1.831504|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.||1.831504|-.5037233|0.1281
71788047|NCT02746874|143073797|SUPERIORITY|||||||0.466|||||||t-test, 2 sided|||||||.466
71788048|NCT02746874|143073798|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||.368
71837212|NCT03131648|143181206|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|8.6||||0.002|TWO_SIDED|95.0|4.1|13.1||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||13.1|4.1|0.002
71837213|NCT03131648|143181207|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|12.1|||<|0.001|TWO_SIDED|95.0|6.5|17.7||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||17.7|6.5|<0.001
71845584|NCT04250194|143205717|NON_INFERIORITY|The noninferiority margin was 10%.|absolute difference in percentage points|5.4||||0.003|TWO_SIDED|95.0|-6.5|17.2||The threshold for statistical significance was p = 0.05. The p value was not adjusted for multiple comparisons.|One-sided two-sample z-test||Difference in diagnostic accuracy = navigational bronchoscopy % - transthoracic biopsy %|||17.2|-6.5|0.003
71755663|NCT03044106|143014262|SUPERIORITY||Mean Difference (Final Values)|2.688237|STANDARD_DEVIATION|3.241751||0|TWO_SIDED|95.0|1.557137|3.819337|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.||3.819337|1.557137|0.00
71755664|NCT03044106|143014262|SUPERIORITY||Mean Difference (Final Values)|2.825||||0.09|TWO_SIDED|95.0|-0.4543|6.0581|||Mixed Models Analysis|||This is the mean difference in effect between active and sham in those with a history of hamstring strain||6.0581|-0.4543|0.090
71755665|NCT03044106|143014262|SUPERIORITY||Mean Difference (Final Values)|-2.024||||0.018|TWO_SIDED|95.0|-3.4474|-0.3406|||Mixed Models Analysis|||This is the mean difference of effect between active and sham in those without a history of hamstring strain.||-0.3406|-3.4474|0.018
71755666|NCT02435992|143014266|SUPERIORITY||Odds Ratio (OR)|3.586||||0.0001|TWO_SIDED|95.0|1.938|6.636|||Cochran-Mantel-Haenszel|||||6.636|1.938|0.0001
71755667|NCT02435992|143014267|SUPERIORITY||Odds Ratio (OR)|2.755||||0.0001|TWO_SIDED|95.0|1.767|4.294|||Cochran-Mantel-Haenszel|||||4.294|1.767|0.0001
71755668|NCT01761877|143014277|OTHER|Mixed Models Analysis|||||<|0.05||||||A p value was calculated for change in breast density from baseline to 12 months separately for each study arm.|Mixed Models Analysis|||The study was designed to assess change in breast density using fat/water MRI after 12 months of sulindac intervention in postmenopausal breast cancer patients taking aromatase inhibitors for the treatment of estrogen receptor positive breast cancer. A non-randomized observation arm was included with the same eligibility criteria to assess change in breast density over 12 months using the fat/water MRI method of quantifying breast density. Change was examined separately for each arm.||||<0.05
71755669|NCT01761877|143014278|OTHER||||||<|0.05||||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
71788049|NCT02746874|143073799|SUPERIORITY|||||||0.509|||||||Wilcoxon (Mann-Whitney)|||||||.509
71788050|NCT02746874|143073800|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||.593
71788051|NCT02746874|143073801|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||0.687
71788052|NCT02746874|143073802|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
71788053|NCT02746874|143073803|SUPERIORITY|||||||0.687|||||||Wilcoxon (Mann-Whitney)|||||||.687
71788054|NCT02746874|143073804|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.840
71788055|NCT02746874|143073805|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||||||.913
71788056|NCT02746874|143073806|SUPERIORITY|||||||0.301|||||||Wilcoxon (Mann-Whitney)|||||||0.301
71788057|NCT02746874|143073807|SUPERIORITY|||||||0.826|||||||Wilcoxon (Mann-Whitney)|||||||0.826
71788058|NCT02746874|143073808|SUPERIORITY|||||||0.813|||||||Wilcoxon (Mann-Whitney)|||||||.813
71788059|NCT02746874|143073810|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||.047
71788060|NCT02746874|143073811|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||||||.115
71788061|NCT02746874|143073812|SUPERIORITY|||||||0.349|||||||Wilcoxon (Mann-Whitney)|||||||.349
71788062|NCT02205814|143073841|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||||||<0.05
71892128|NCT04178590|143305813|SUPERIORITY|||||||0.871||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.871
71892129|NCT04178590|143305814|SUPERIORITY|||||||0.773||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.773
71892130|NCT04178590|143305815|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892131|NCT04178590|143305816|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|p\<0.05||||||0.000
71892132|NCT04178590|143305817|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892133|NCT04178590|143305818|SUPERIORITY|||||||0.063||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.063
71892134|NCT04178590|143305819|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71755670|NCT01761877|143014279|OTHER||||||<|0.05|TWO_SIDED|95.0||||A p value of \<0.05 was selected for change in each arm. The study did not include a direct comparison between the two arms.|Mixed Models Analysis|||||||<0.05
71755671|NCT01353898|143014301|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.62|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 200 mg MK-1972 once daily||||
71755672|NCT01353898|143014301|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 800 mg MK-1972 once daily||||
71755673|NCT01353898|143014302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||||||||||||||||
71755674|NCT01353898|143014302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||||||||||||||||
71755675|NCT01353898|143014302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||||||||||||||||
71755676|NCT01353898|143014302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||||||||||||||||
71755677|NCT01353898|143014302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.83||||||||||||||||||
71755678|NCT04973449|143014336|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.08|1.32||||||The analyses were derived using analysis of covariance (ANCOVA).||1.32|1.08|
71755679|NCT04973449|143014337|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.14||||||The analyses were derived using ANCOVA.||1.14|0.90|
71755680|NCT04973449|143014338|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|1.68|||||TWO_SIDED|95.0|-3.11|6.49||||||The analyses were derived using ANCOVA.||6.49|-3.11|
71755681|NCT04973449|143014339|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|3.47|||||TWO_SIDED|95.0|3.09|3.89||||||The analyses were derived using ANCOVA.||3.89|3.09|
71755682|NCT04973449|143014342|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.21|||||TWO_SIDED|95.0|3.06|3.36||||||The analyses were derived using ANCOVA.||3.36|3.06|
71788063|NCT02205814|143073842|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||All secondary efficacy variables were analysed on the ITT population only. Multiplicity was adjusted using the Hochberg procedure. The continuous secondary efficacy variables were analysed over time and were treated in the same way as the primary efficacy variable with respective output.||||<0.05
71788064|NCT02756689|143073874|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71755683|NCT04973449|143014343|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.45|0.56||||||The analyses were derived using ANCOVA.||0.56|0.45|
71755684|NCT04973449|143014344|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.31|||||TWO_SIDED|95.0|0.27|0.35||||||The analyses were derived using ANCOVA.||0.35|0.27|
71671142|NCT03349060|142860122|SUPERIORITY||Difference in Percentage|6.5||||0.0869|TWO_SIDED|95.0|-0.3|13.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.3|-0.3|0.0869
71755685|NCT04973449|143014345|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.25|1.58||||||The analyses were derived using ANCOVA.||1.58|1.25|
71755686|NCT04973449|143014346|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.84|||||TWO_SIDED|95.0|1.63|2.08||||||The analyses were derived using ANCOVA.||2.08|1.63|
71755687|NCT04973449|143014347|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||The analyses were derived using ANCOVA.||0.99|0.78|
71755688|NCT04973449|143014348|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97||||||The analyses were derived using ANCOVA.||0.97|0.78|
71755689|NCT04973449|143014349|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.95|||||TWO_SIDED|95.0|0.83|1.08||||||The analyses were derived using ANCOVA.||1.08|0.83|
71755690|NCT04973449|143014350|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|6.56|||||TWO_SIDED|95.0|5.82|7.4||||||The analyses were derived using ANCOVA.||7.40|5.82|
71755691|NCT04973449|143014351|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.22|||||TWO_SIDED|95.0|1.99|2.47||||||The analyses were derived using ANCOVA.||2.47|1.99|
71755692|NCT04973449|143014352|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group is \> 0.67.|GMT ratio|4.35|||||TWO_SIDED|95.0|3.86|4.9||||||The analyses were derived using ANCOVA.||4.90|3.86|
71788065|NCT02756689|143073875|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
71788066|NCT02756689|143073876|SUPERIORITY||Risk Ratio (RR)|2.1||||0.09|TWO_SIDED|95.0|0.8|5.3|||Chi-squared|||||5.3|0.8|0.09
71671143|NCT03349060|142860122|SUPERIORITY||Difference in Percentage|20.3||||0.0001|TWO_SIDED|95.0|12.0|28.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.6|12.0|0.0001
71755693|NCT04973449|143014353|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.25|||||TWO_SIDED|95.0|1.13|1.39||||||The analyses were derived using ANCOVA.||1.39|1.13|
71755694|NCT04973449|143014354|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|4.42|||||TWO_SIDED|95.0|3.85|5.08||||||The analyses were derived using ANCOVA.||5.08|3.85|
71755695|NCT04973449|143014355|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-1.24|||||TWO_SIDED|95.0|-6.62|3.84||||||The analyses were derived using ANCOVA.||3.84|-6.62|
71755696|NCT04973449|143014356|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.86|||||TWO_SIDED|95.0|10.18|23.32||||||The analyses were derived using ANCOVA.||23.32|10.18|
71755697|NCT04973449|143014357|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.12|||||TWO_SIDED|95.0|-24.22|-12.07||||||The analyses were derived using ANCOVA.||-12.07|-24.22|
71755698|NCT04973449|143014358|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-7.28|7.23||||||The analyses were derived using ANCOVA.||7.23|-7.28|
71755699|NCT04973449|143014359|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|31.36|||||TWO_SIDED|95.0|24.44|37.82||||||The analyses were derived using ANCOVA.||37.82|24.44|
71755700|NCT04973449|143014360|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-3.55|||||TWO_SIDED|95.0|-9.4|1.9||||||The analyses were derived using ANCOVA.||1.90|-9.40|
71755701|NCT04973449|143014361|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|23.01|||||TWO_SIDED|95.0|15.41|30.23||||||The analyses were derived using ANCOVA.||30.23|15.41|
71755702|NCT04973449|143014362|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-34.24|||||TWO_SIDED|95.0|-40.77|-27.45||||||The analyses were derived using ANCOVA.||-27.45|-40.77|
71788067|NCT02756689|143073877|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||0.12
71755703|NCT04973449|143014363|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.96|||||TWO_SIDED|95.0|-1.31|15.1||||||The analyses were derived using ANCOVA.||15.10|-1.31|
71755704|NCT04973449|143014364|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|29.05|||||TWO_SIDED|95.0|21.76|35.81||||||The analyses were derived using ANCOVA.||35.81|21.76|
71755705|NCT04973449|143014366|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.3|1.42||||||The analyses were derived using ANCOVA.||1.42|1.30|
71755706|NCT04973449|143014367|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||The analyses were derived using ANCOVA.||0.81|0.70|
71755707|NCT04973449|143014368|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|3.87|||||TWO_SIDED|95.0|3.4|4.39||||||The analyses were derived using ANCOVA.||4.39|3.40|
71755708|NCT04973449|143014369|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.67|||||TWO_SIDED|95.0|0.64|0.7||||||The analyses were derived using ANCOVA.||0.70|0.64|
71755709|NCT04973449|143014370|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.58|||||TWO_SIDED|95.0|-0.61|2.09||||||The analyses were derived using ANCOVA.||2.09|-0.61|
71755710|NCT04973449|143014371|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-35.18|||||TWO_SIDED|95.0|-41.46|-28.44||||||The analyses were derived using ANCOVA.||-28.44|-41.46|
71755711|NCT04973449|143014372|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-24.93|||||TWO_SIDED|95.0|-31.06|-18.56||||||The analyses were derived using ANCOVA.||-18.56|-31.06|
71755712|NCT04973449|143014373|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-0.02|||||TWO_SIDED|95.0|-1.63|1.56||||||The analyses were derived using ANCOVA.||1.56|-1.63|
71788068|NCT02756689|143073878|SUPERIORITY||Risk Ratio (RR)|3.3||||0.06|TWO_SIDED|95.0|0.9|11.4|||Chi-squared|||||11.4|0.9|0.06
71788069|NCT02756689|143073879|SUPERIORITY||Risk Ratio (RR)|0.8||||0.74|TWO_SIDED|95.0|0.2|2.8|||Chi-squared|||||2.8|0.2|0.74
71788070|NCT02756689|143073880|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71788071|NCT02756689|143073881|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
71671144|NCT03349060|142860122|SUPERIORITY||Difference in Percentage|13.1||||0.0259|TWO_SIDED|95.0|2.6|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.6|2.6|0.0259
71755713|NCT04973449|143014374|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-19.18|||||TWO_SIDED|95.0|-23.8|-14.98||||||The analyses were derived using ANCOVA.||-14.98|-23.80|
71755714|NCT04973449|143014375|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|39.18|||||TWO_SIDED|95.0|32.68|45.21||||||The analyses were derived using ANCOVA.||45.21|32.68|
71755715|NCT04973449|143014376|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-1.62|1.62||||||The analyses were derived using ANCOVA.||1.62|-1.62|
71755716|NCT04973449|143014377|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.52|||||TWO_SIDED|95.0|0.45|0.59||||||The analyses were derived using ANCOVA.||0.59|0.45|
71755717|NCT04973449|143014378|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.76|||||TWO_SIDED|95.0|0.68|0.86||||||The analyses were derived using ANCOVA.||0.86|0.68|
71755718|NCT04973449|143014379|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.6|||||TWO_SIDED|95.0|1.43|1.79||||||The analyses were derived using ANCOVA.||1.79|1.43|
71755719|NCT04973449|143014380|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||The analyses were derived using ANCOVA.||0.85|0.67|
71788072|NCT02756689|143073882|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71788073|NCT02756689|143073883|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
71788074|NCT02756689|143073884|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71837214|NCT03131648|143181208|SUPERIORITY||Risk Difference (RD)|9.7||||0.002|TWO_SIDED|95.0|4.4|15.0||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance.||15|4.4|0.002
71837215|NCT03131648|143181209|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-10.4|||<|0.001|TWO_SIDED|95.0|-14.4|-6.5||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or after initiation of rescue medication were not included in the analysis.||-6.5|-14.4|<0.001
71837216|NCT03131648|143181210|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-2.1||||0.002|TWO_SIDED|95.0|-3.4|-0.8||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-0.8|-3.4|0.002
71892135|NCT04178590|143305820|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71755720|NCT04973449|143014381|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
71755721|NCT04973449|143014382|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.5|||||TWO_SIDED|95.0|7.07|21.71||||||The analyses were derived using ANCOVA.||21.71|7.07|
71755722|NCT04973449|143014383|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-18.1|||||TWO_SIDED|95.0|-24.13|-12.1||||||The analyses were derived using ANCOVA.||-12.10|-24.13|
71755723|NCT04973449|143014384|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|16.87|||||TWO_SIDED|95.0|10.15|23.4||||||The analyses were derived using ANCOVA.||23.40|10.15|
71755724|NCT04973449|143014385|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|0.0|||||TWO_SIDED|95.0|-7.21|7.21||||||The analyses were derived using ANCOVA.||7.21|-7.21|
71788075|NCT02756689|143073885|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.2|4.7|||Chi-squared|||||4.7|0.2|>0.99
71788076|NCT02756689|143073886|SUPERIORITY||Risk Ratio (RR)|0.7||||0.43|TWO_SIDED|95.0|0.3|1.7|||Chi-squared|||||1.7|0.3|0.43
71788077|NCT02756689|143073887|SUPERIORITY||Risk Ratio (RR)|0.3||||0.09|TWO_SIDED|95.0|0.1|1.3|||Chi-squared|||||1.3|0.1|0.09
71788078|NCT02756689|143073888|SUPERIORITY||Risk Ratio (RR)|0.7||||0.68|TWO_SIDED|95.0|0.1|3.8|||Chi-squared|||||3.8|0.1|0.68
71788079|NCT02756689|143073889|SUPERIORITY||Risk Ratio (RR)|0.8||||0.73|TWO_SIDED|95.0|0.3|2.6|||Chi-squared|||||2.6|0.3|0.73
71788080|NCT02756689|143073890|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71788081|NCT02756689|143073891|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.1|15.4|||Chi-squared|||||15.4|0.1|>0.99
71788082|NCT02756689|143073892|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71755725|NCT04973449|143014386|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28||||||The analyses were derived using ANCOVA.||2.28|1.75|
71755726|NCT04973449|143014387|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|2.96|||||TWO_SIDED|95.0|2.64|3.32||||||The analyses were derived using ANCOVA.||3.32|2.64|
71755727|NCT04973449|143014388|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.35|1.69||||||The analyses were derived using ANCOVA.||1.69|1.35|
71755728|NCT04973449|143014389|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.85|||||TWO_SIDED|95.0|0.78|0.94||||||The analyses were derived using ANCOVA.||0.94|0.78|
71755729|NCT04973449|143014390|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-41.2|||||TWO_SIDED|95.0|-47.57|-34.41||||||The analyses were derived using ANCOVA.||-34.41|-47.57|
71755730|NCT04973449|143014391|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|6.05|||||TWO_SIDED|95.0|-1.81|13.77||||||The analyses were derived using ANCOVA.||13.77|-1.81|
71755731|NCT04973449|143014392|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|-26.56|||||TWO_SIDED|95.0|-33.1|-19.94||||||The analyses were derived using ANCOVA.||-19.94|-33.10|
71755732|NCT04973449|143014393|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|30.69|||||TWO_SIDED|95.0|22.94|37.9||||||The analyses were derived using ANCOVA.||37.90|22.94|
71755733|NCT04973449|143014394|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI rate difference in seroresponse between the comparator group and reference group was \> or =-10%.|Seroresponse difference|14.64|||||TWO_SIDED|95.0|6.36|22.64||||||The analyses were derived using ANCOVA.||22.64|6.36|
71755734|NCT04973449|143014395|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.84|||||TWO_SIDED|95.0|0.74|0.96||||||The analyses were derived using analysis of covariance (ANCOVA).||0.96|0.74|
71755735|NCT04973449|143014396|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.62|1.8||||||The analyses were derived using ANCOVA.||1.80|1.62|
71755736|NCT04973449|143014397|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.5|||||TWO_SIDED|95.0|0.44|0.56||||||The analyses were derived using ANCOVA.||0.56|0.44|
71755737|NCT04973449|143014398|NON_INFERIORITY|Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio of the comparator group and reference group was \> 0.67.|GMT ratio|0.38|||||TWO_SIDED|95.0|0.32|0.44||||||The analyses were derived using ANCOVA.||0.44|0.32|
71755738|NCT04408989|143014568|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.943|||||TWO_SIDED|90.0|0.899|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.899|
71755739|NCT04408989|143014568|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.0|||||TWO_SIDED|90.0|0.956|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.956|
71755740|NCT04408989|143014568|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of AUC(0-∞) were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter AUC(0-∞) was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.01|1.12|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.12|1.01|
71755741|NCT04408989|143014569|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.937|||||TWO_SIDED|90.0|0.887|0.989|||||For the comparison, MB02 SP represents the numerator and MB02 DM represents the denominator.|||0.989|0.887|
71755742|NCT04408989|143014569|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.983|||||TWO_SIDED|90.0|0.925|1.05|||||For the comparison, MB02 SP represents the numerator and US Avastin represents the denominator.|||1.05|0.925|
71788083|NCT02756689|143073893|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71788084|NCT02756689|143073894|SUPERIORITY||Risk Ratio (RR)|0.3||||0.37|TWO_SIDED|95.0|0.03|2.3|||Chi-squared|||||2.3|0.03|0.37
71788085|NCT02756689|143073895|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71788086|NCT02756689|143073896|SUPERIORITY||Risk Ratio (RR)|0.5||||0.62|TWO_SIDED|95.0|0.05|5.3|||Chi-squared|||||5.3|0.05|0.62
71788087|NCT02756689|143073897|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.3|3.2|||Chi-squared|||||3.2|0.3|>0.99
71788088|NCT02756689|143073898|SUPERIORITY|||||||0.234|||||||Wilcoxon (Mann-Whitney)|||||||0.234
71671145|NCT03349060|142860122|SUPERIORITY||Difference in Percentage|33.0|||<|0.0001|TWO_SIDED|95.0|21.7|44.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.2|21.7|<0.0001
71671146|NCT03349060|142860122|SUPERIORITY||Difference in Percentage|25.0||||0.0001|TWO_SIDED|95.0|14.2|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.8|14.2|0.0001
71755743|NCT04408989|143014569|EQUIVALENCE|"PK similarity was achieved if the 90% CIs for the biosimilar-to-reference ratios of Cmax were within the predefined 0.80-1.25 acceptance similarity criteria.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.05|||||TWO_SIDED|90.0|0.991|1.11|||||For the comparison, MB02 DM represents the numerator and US Avastin represents the denominator.|||1.11|0.991|
71755744|NCT03373240|143014608|OTHER|Examining stop signal reaction time changed across the 4-week training period|Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|2.79||0.003|TWO_SIDED|95.0|-14.17|-3.06|||Mixed Models Analysis|||||-3.06|-14.17|.003
71788089|NCT02756689|143073899|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71788090|NCT02756689|143073900|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71788091|NCT02756689|143073901|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71788092|NCT02756689|143073902|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71788093|NCT02756689|143073903|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71788094|NCT02756689|143073904|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71755745|NCT03373240|143014609|SUPERIORITY||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.127||0.049|TWO_SIDED|95.0|-0.333|0.184|||ANOVA|||||.184|-.333|.049
71788095|NCT02756689|143073905|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71788096|NCT02756689|143073906|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71788097|NCT02756689|143073907|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71788098|NCT02756689|143073908|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71788099|NCT02756689|143073909|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71671147|NCT03349060|142860122|SUPERIORITY||Difference in Percentage|44.6|||<|0.0001|TWO_SIDED|95.0|33.6|55.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.6|33.6|<0.0001
71755746|NCT03373240|143014610|SUPERIORITY||Mean Difference (Net)|-1.914|STANDARD_ERROR_OF_MEAN|1.011||0.236|TWO_SIDED|95.0|-3.965|0.136|||ANOVA|||||.136|-3.965|.236
71788100|NCT02756689|143073910|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71788101|NCT02756689|143073911|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71788102|NCT02756689|143073912|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71788103|NCT02756689|143073913|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71788104|NCT02756689|143073914|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71788105|NCT02237950|143073915|SUPERIORITY|||||||0.015|||||||Regression, Logistic|||||||0.015
71788106|NCT02237950|143073916|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
71788107|NCT02237950|143073917|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||||||0.002
71788108|NCT02237950|143073918|SUPERIORITY|||||||0.014|||||||Regression, Logistic|||||||0.014
71788109|NCT02237950|143073919|SUPERIORITY|||||||0.012|||||||Regression, Logistic|||||||0.012
71788110|NCT02237950|143073920|SUPERIORITY|||||||0.059|||||||Regression, Logistic|||||||0.059
71788111|NCT02237950|143073921|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||||||0.008
71788112|NCT01574326|143073926|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.9||||0.001|TWO_SIDED|95.0|-1.44|-0.37|||ANCOVA|Threshold for significance ≤ 0.05.||Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.||-0.37|-1.44|0.001
71788113|NCT01862874|143074039|SUPERIORITY||Vaccine Efficacy|85.9|||<|0.001|TWO_SIDED|95.0|52.7|97.3|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 group versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.|97.3|52.7|<0.001
71788114|NCT01862874|143074040|OTHER|Statistical testing of no difference in incidence of maximum temperature ≥37.5°C|Risk Difference (RD)|-1.2||||0.256|TWO_SIDED|95.0|-3.5|0.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.9|-3.5|0.256
71788115|NCT01862874|143074041|OTHER|Statistical testing of no difference in incidence of injection-site erythema|Risk Difference (RD)|2.9||||0.251|TWO_SIDED|95.0|-2.1|7.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site erythema||7.9|-2.1|0.251
71788116|NCT01862874|143074041|OTHER|Statistical testing of no difference in incidence of injection-site pain|Risk Difference (RD)|6.4||||0.033|TWO_SIDED|95.0|0.5|12.2|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site pain||12.2|0.5|0.033
71755747|NCT03373240|143014611|OTHER|Examining whether percentage of risky choices decreased across the 4-wwek training period.|Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.77||0.039|TWO_SIDED|95.0|-3.15|-0.08|||Mixed Models Analysis|||||-.08|-3.15|.039
71755748|NCT03373240|143014612|OTHER||Mean Difference (Net)|-1.77|STANDARD_ERROR_OF_MEAN|0.82||0.035|TWO_SIDED|95.0|-3.4|-0.13|||Mixed Models Analysis|||||-.13|-3.40|.035
71755749|NCT03373240|143014613|OTHER||Mean Difference (Net)|4.26|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|3.12|5.39|||Mixed Models Analysis|||||5.39|3.12|<.001
71755750|NCT03373240|143014614|SUPERIORITY||Mean Difference (Net)|0.933|STANDARD_ERROR_OF_MEAN|0.403||0.008|TWO_SIDED|95.0|0.111|1.755|||ANOVA|||||1.755|.111|.008
71755751|NCT03373240|143014615|SUPERIORITY||Mean Difference (Net)|0.019|STANDARD_ERROR_OF_MEAN|0.096||0.077|TWO_SIDED|97.0|-0.177|0.214|||ANOVA|||||.214|-.177|.077
71755752|NCT03373240|143014616|SUPERIORITY||Mean Difference (Net)|-0.964|STANDARD_ERROR_OF_MEAN|1.902||0.547|TWO_SIDED|95.0|-4.822|2.895|||ANOVA|||||2.895|-4.822|.547
71755753|NCT03373240|143014617|SUPERIORITY||Mean Difference (Net)|-0.532|STANDARD_ERROR_OF_MEAN|0.628||0.436|TWO_SIDED|95.0|-1.805|0.742|||ANOVA|||||.742|-1.805|.436
71755754|NCT05737069|143014629|EQUIVALENCE|The two products were considered to be bioequivalent if 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0008|||||TWO_SIDED|90.0|0.9698|1.0327||||||||1.0327|0.9698|
71755755|NCT05737069|143014630|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|1.0023|||||TWO_SIDED|90.0|0.971|1.0346||||||||1.0346|0.9710|
71755756|NCT05737069|143014631|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9825|||||TWO_SIDED|90.0|0.9383|1.0288||||||||1.0288|0.9383|
71755757|NCT05737069|143014632|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC(0-t) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9916|||||TWO_SIDED|90.0|0.9755|1.0081||||||||1.0081|0.9755|
71755758|NCT05737069|143014633|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for AUC (0-inf) were contained within the acceptance interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9776|||||TWO_SIDED|90.0|0.9432|1.0133||||||||1.0133|0.9432|
71755759|NCT05737069|143014634|EQUIVALENCE|The two products were considered to be bioequivalent if 90% CIs for the GMR (Test/Reference) for Cmax were contained within the interval of 0.8 to 1.25.|Geometric Mean Ratio|0.9982|||||TWO_SIDED|90.0|0.9431|1.0567||||||||1.0567|0.9431|
71755760|NCT04050553|143014646|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.7556|TWO_SIDED|95.0|-3.64|2.67|||Mixed Models Analysis|||||2.67|-3.64|0.7556
71755761|NCT04050553|143014647|SUPERIORITY||LS Mean Difference|-174.77||||0.0043|TWO_SIDED|95.0|-290.34|-59.21|||Mixed Models Analysis|||||-59.21|-290.34|0.0043
71755762|NCT04050553|143014648|SUPERIORITY||LS Mean Difference|-488.31|||<|0.0001|TWO_SIDED|95.0|-621.25|-355.36|||Mixed Models Analysis|||||-355.36|-621.25|<0.0001
71755763|NCT04050553|143014649|SUPERIORITY||LS Mean Difference|4.39||||0.0023|TWO_SIDED|95.0|1.69|7.08|||Mixed Models Analysis|||||7.08|1.69|0.0023
71755764|NCT04050553|143014650|SUPERIORITY||LS Mean Difference|-0.06||||0.0505|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 100 mg/dL.||0.00|-0.13|0.0505
71755765|NCT04050553|143014650|SUPERIORITY||LS Mean Difference|-0.18||||0.0104|TWO_SIDED|95.0|-0.31|-0.05|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 63 mg/dL.||-0.05|-0.31|0.0104
71755766|NCT04050553|143014650|SUPERIORITY||LS Mean Difference|-0.19||||0.0068|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 45 mg/dL.||-0.06|-0.32|0.0068
71755767|NCT04050553|143014650|SUPERIORITY||LS Mean Difference|-0.11||||0.2302|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||For Overall Hypoglycemia Symptom Score at concentration of 72 mg/dL.||0.08|-0.30|0.2302
71755768|NCT04050553|143014651|SUPERIORITY||LS Mean Difference|-0.51||||0.8298|TWO_SIDED|95.0|-5.28|4.27|||Mixed Models Analysis|||For systolic blood pressure.||4.27|-5.28|0.8298
71755769|NCT04050553|143014651|SUPERIORITY||LS Mean Difference|1.96||||0.1516|TWO_SIDED|95.0|-0.76|4.67|||Mixed Models Analysis|||For diastolic blood pressure.||4.67|-0.76|0.1516
71755770|NCT04050553|143014652|SUPERIORITY||LS Mean Difference|-0.89||||0.5776|TWO_SIDED|95.0|-4.1|2.33|||Mixed Models Analysis|||||2.33|-4.10|0.5776
71755771|NCT02201953|143014663|NON_INFERIORITY_OR_EQUIVALENCE|Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)|Difference in proportions|14.4|||||TWO_SIDED|95.0|9.2|19.6|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||19.6|9.2|
71755772|NCT02201953|143014663|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.|Cochran-Mantel-Haenszel|||If the lower bound of 95% CI on the difference was \> -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.||||<0.001
71755773|NCT02153632|143014675|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|1.75||0.031|TWO_SIDED|95.0|-10.5|-0.5|||ANCOVA|||||-0.5|-10.5|0.031
71755774|NCT02153632|143014675|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|1.71||0.011|TWO_SIDED|95.0|-11.5|-1.5|||ANCOVA|||||-1.5|-11.5|0.011
71755775|NCT02892344|143014710|SUPERIORITY||Mean Difference (Net)|0.182|||<|0.001|TWO_SIDED|95.0|0.148|0.217|||Mixed Models Analysis|||||0.217|0.148|<0.001
71755776|NCT02892344|143014711|SUPERIORITY||Mean Difference (Net)|-0.218|||<|0.001|TWO_SIDED|95.0|-0.293|-0.143|||Mixed Models Analysis|||||-0.143|-0.293|<0.001
71755777|NCT02892344|143014712|SUPERIORITY||Mean Difference (Net)|0.132|||<|0.001|TWO_SIDED|95.0|0.105|0.158|||Mixed Models Analysis|||||0.158|0.105|<0.001
71755778|NCT02892344|143014713|SUPERIORITY||Mean Difference (Net)|0.176|||<|0.001|TWO_SIDED|95.0|0.145|0.207|||Mixed Models Analysis|||||0.207|0.145|<0.001
71755779|NCT02892344|143014714|SUPERIORITY||Mean Difference (Net)|0.1|||<|0.001|TWO_SIDED|95.0|0.061|0.139|||Mixed Models Analysis|||Pre-dose trough FVC||0.139|0.061|<0.001
71755780|NCT02892344|143014714|SUPERIORITY||Mean Difference (Net)|0.288|||<|0.001|TWO_SIDED|95.0|0.231|0.345|||Mixed Models Analysis|||Pre-dose trough FEF25-75%||0.345|0.231|<0.001
71755781|NCT02892344|143014715|SUPERIORITY||Mean Difference (Net)|27.2|||<|0.001|TWO_SIDED|95.0|22.1|32.4|||Mixed Models Analysis|||Mean Morning PEF||32.4|22.1|<0.001
71755782|NCT02892344|143014715|SUPERIORITY||Mean Difference (Net)|26.1|||<|0.001|TWO_SIDED|95.0|21.0|31.2|||Mixed Models Analysis|||Mean Evening PEF||31.2|21.0|<0.001
71755783|NCT02892344|143014718|SUPERIORITY||Mean Difference (Net)|-0.204|||<|0.001|TWO_SIDED|95.0|-0.277|-0.131|||Mixed Models Analysis|||||-0.131|-0.277|<0.001
71755784|NCT02892344|143014719|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.05|||Mixed Models Analysis|||Night-time number of puffs of rescue medication||-0.05|-0.16|<0.001
71755785|NCT02892344|143014719|SUPERIORITY||Mean Difference (Net)|-0.15|||<|0.001|TWO_SIDED|95.0|-0.22|-0.08|||Mixed Models Analysis|||Daytime number of puffs of rescue medication||-0.08|-0.22|<0.001
71671148|NCT03349060|142860123|SUPERIORITY||Difference in Percentage|3.9||||0.0802|TWO_SIDED|95.0|-0.7|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||8.5|-0.7|0.0802
71755786|NCT02892344|143014720|SUPERIORITY||Mean Difference (Net)|8.1|||<|0.001|TWO_SIDED|95.0|4.3|11.8|||Mixed Models Analysis|||||11.8|4.3|<0.001
71755787|NCT02892344|143014721|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.064|0.234|||Mixed Models Analysis|||||0.234|0.064|<0.001
71755788|NCT02892344|143014724|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.14|0.59|||Regression, Cox|||||0.59|0.14|<0.001
71755789|NCT01084655|143014778|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square(LS)Means|1.204|||||TWO_SIDED|90.0|0.87|1.666||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.666|0.870|
71755790|NCT01084655|143014779|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.074|||||TWO_SIDED|90.0|0.793|1.455||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.455|0.793|
71755791|NCT01084655|143014782|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.066|||||TWO_SIDED|90.0|0.802|1.417||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.417|0.802|
71755792|NCT01084655|143014783|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.068|||||TWO_SIDED|90.0|0.955|1.195||||||ANOVA with dose level as a fixed effect and participant as a random effect.||1.195|0.955|
71755793|NCT01074814|143014798|OTHER||||||||||||||||||Results for the primary objective - evaluation of GMI - were presented with descriptive statistics as the ration of PFS on current therapy over the PFS on latest therapy. The percentage of patients with GMI greater than 1.3 was displayed along with its corresponding 95% exact confidence interval.|||
71755794|NCT05024032|143014805|SUPERIORITY||LS Mean Difference|-12.0|||<|0.001|TWO_SIDED|95.0|-14.8|-9.3|||Mixed Models Analysis|||||-9.3|-14.8|<0.001
71755795|NCT05024032|143014805|SUPERIORITY||LS Mean Difference|-17.5|||<|0.001|TWO_SIDED|95.0|-20.3|-14.8|||Mixed Models Analysis|||||-14.8|-20.3|<0.001
71755796|NCT05024032|143014806|SUPERIORITY||Odds Ratio (OR)|23.11|||<|0.001|TWO_SIDED|95.0|8.8|60.69|||Regression, Logistic|||||60.69|8.80|<0.001
71755797|NCT05024032|143014806|SUPERIORITY||Odds Ratio (OR)|26.53|||<|0.001|TWO_SIDED|95.0|9.61|73.24|||Regression, Logistic|||||73.24|9.61|<0.001
71755798|NCT05024032|143014807|SUPERIORITY||LS Mean Difference|-7.2|||<|0.001|TWO_SIDED|95.0|-8.8|-5.5|||Mixed Models Analysis|||||-5.5|-8.8|<0.001
71755799|NCT05024032|143014807|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-10.9|-7.5|||Mixed Models Analysis|||||-7.5|-10.9|<0.001
71755800|NCT05024032|143014808|SUPERIORITY||Odds Ratio (OR)|13.19|||<|0.001|TWO_SIDED|95.0|5.63|30.89|||Regression, Logistic|||||30.89|5.63|<0.001
71755801|NCT05024032|143014808|SUPERIORITY||Odds Ratio (OR)|28.58|||<|0.001|TWO_SIDED|95.0|11.23|72.71|||Regression, Logistic|||||72.71|11.23|<0.001
71755802|NCT05024032|143014809|SUPERIORITY||Odds Ratio (OR)|25.64|||<|0.001|TWO_SIDED|95.0|6.68|98.49|||Regression, Logistic|||||98.49|6.68|<0.001
71755803|NCT05024032|143014809|SUPERIORITY||Odds Ratio (OR)|69.79|||<|0.001|TWO_SIDED|95.0|17.69|275.37|||Regression, Logistic|||||275.37|17.69|<0.001
71755804|NCT05024032|143014810|SUPERIORITY||LS Mean Difference|-9.2|||<|0.001|TWO_SIDED|95.0|-11.5|-6.9|||Mixed Models Analysis|||||-6.9|-11.5|<0.001
71755805|NCT05024032|143014810|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-16.0|-11.3|||Mixed Models Analysis|||||-11.3|-16.0|<0.001
71892136|NCT04178590|143305821|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892137|NCT04178590|143305822|SUPERIORITY|||||||0.085||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.085
71892138|NCT04178590|143305823|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892139|NCT04178590|143305824|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892140|NCT04178590|143305825|SUPERIORITY|||||||0.895||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.895
71892141|NCT04178590|143305826|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
71892142|NCT04178590|143305827|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
71892143|NCT04178590|143305828|SUPERIORITY|||||||0.008||||||p\<0.05|McNemar|||||||0.008
71892144|NCT04178590|143305829|SUPERIORITY|||||||0.5||||||p\<0.05|McNemar|||||||0.500
71892145|NCT04178590|143305830|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
71892146|NCT04178590|143305831|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
71755806|NCT05024032|143014811|SUPERIORITY||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-13.5|-8.3|||Mixed Models Analysis|||||-8.3|-13.5|<0.001
71755807|NCT05024032|143014811|SUPERIORITY||LS Mean Difference|-16.0|||<|0.001|TWO_SIDED|95.0|-18.6|-13.4|||Mixed Models Analysis|||||-13.4|-18.6|<0.001
71755808|NCT05024032|143014812|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-4.8|-3.1|||Mixed Models Analysis|||||-3.1|-4.8|<0.001
71755809|NCT05024032|143014812|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|95.0|-6.4|-4.8|||Mixed Models Analysis|||||-4.8|-6.4|<0.001
71755810|NCT05024032|143014813|SUPERIORITY||LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.46|-0.28|||Mixed Models Analysis|||||-0.28|-0.46|<0.001
71755811|NCT05024032|143014813|OTHER||LS Mean Difference|-0.39|||<|0.001|TWO_SIDED|95.0|-0.48|-0.29|||Mixed Models Analysis|||||-0.29|-0.48|<0.001
71755812|NCT05024032|143014814|SUPERIORITY||LS Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.61|-0.32|||Mixed Models Analysis|||||-0.32|-0.61|<0.001
71755813|NCT05024032|143014814|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.69|-0.4|||Mixed Models Analysis|||||-0.40|-0.69|<0.001
71755814|NCT05024032|143014815|SUPERIORITY||LS Mean Difference|1.2||||0.044|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.044
71755815|NCT05024032|143014815|SUPERIORITY||LS Mean Difference|1.2||||0.05|TWO_SIDED|95.0|0.0|2.3|||ANCOVA|||||2.3|0.0|0.050
71755816|NCT05024032|143014816|SUPERIORITY||LS Mean Difference|7.8|||<|0.001|TWO_SIDED|95.0|3.7|11.8|||ANCOVA|||||11.8|3.7|<0.001
71788117|NCT01862874|143074041|OTHER|Statistical testing of no difference in incidence of injection-site swelling|Risk Difference (RD)|6.8||||0.003|TWO_SIDED|95.0|2.3|11.3|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|Injection-site swelling||11.3|2.3|0.003
71788118|NCT01862874|143074042|OTHER|Statistical testing of no difference in incidence of systemic AEs|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-5.2|3.3|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||3.3|-5.2|
71788119|NCT01862874|143074043|OTHER|Statistical testing of no difference in incidence of vaccine-related systemic AEs|Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-4.1|0.8|||||Risk difference (V501 - placebo) was estimated using the Miettinen \& Nurminen method.|||0.8|-4.1|
71755817|NCT05024032|143014816|SUPERIORITY||LS Mean Difference|8.5|||<|0.001|TWO_SIDED|95.0|4.4|12.7|||ANCOVA|||||12.7|4.4|<0.001
71755818|NCT05024032|143014817|SUPERIORITY||LS Mean Difference|-4.8|||<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||Mixed Models Analysis|||||-2.7|-6.9|<0.001
71788120|NCT01862874|143074044|SUPERIORITY||Vaccine Efficacy|86.5|||<|0.001|TWO_SIDED|95.0|55.2|97.4|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.|97.4|55.2|<0.001
71788121|NCT03178903|143074045|SUPERIORITY||Mean Difference (Final Values)|0.678||||0.87|TWO_SIDED|||||p\<.05 was the a priori threshold for statistical significance.|ANCOVA|Covarying for baseline depressive symptoms and MVPA.||||||.87
71788122|NCT00060008|143074046|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71671149|NCT03349060|142860123|SUPERIORITY||Difference in Percentage|9.8||||0.0045|TWO_SIDED|95.0|4.0|15.7||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.7|4.0|0.0045
71755819|NCT05024032|143014818|SUPERIORITY||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-9.1|-3.1|||Mixed Models Analysis|||||-3.1|-9.1|<0.001
71755820|NCT05024032|143014819|SUPERIORITY||LS Mean Difference|-0.31|||||TWO_SIDED|95.0|-0.51|-0.11||||||||-0.11|-0.51|
71755821|NCT05024032|143014820|SUPERIORITY||LS Mean Difference|0.09|||||TWO_SIDED|95.0|0.03|0.14||||||||0.14|0.03|
71755822|NCT05024032|143014821|SUPERIORITY||LS Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.25|0.13||||||||0.13|-0.25|
71755823|NCT05024032|143014822|SUPERIORITY||LS Mean Difference|-0.25|||||TWO_SIDED|95.0|-0.34|-0.16||||||||-0.16|-0.34|
71755824|NCT05024032|143014823|SUPERIORITY||LS Mean Difference|-0.58|||||TWO_SIDED|95.0|-0.79|-0.37||||||||-0.37|-0.79|
71755825|NCT05024032|143014824|SUPERIORITY||LS Mean Difference|-0.07|||||TWO_SIDED|95.0|-0.12|-0.01||||||||-0.01|-0.12|
71755826|NCT05024032|143014825|SUPERIORITY||LS Mean Difference|-6.3|||||TWO_SIDED|95.0|-8.6|-4.0||||||||-4.0|-8.6|
71755827|NCT03591406|143014834|NON_INFERIORITY|Pre-defined non-inferiority margin of -15%|Difference in proportions|1.12|||||TWO_SIDED|95.0|-2.15|4.71|||||2-sided 95% Confidence Interval (CI) was computed using the Wilson score method with continuity correction described by Newcombe.|||4.71|-2.15|
71755828|NCT02066181|143014846|SUPERIORITY||Hazard Ratio (HR)|11.3|||<|0.001|ONE_SIDED|95.0|5.7||||Log Rank||||||5.7|<0.001
71758545|NCT02205736|143019222|SUPERIORITY|||||||0.0707||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 12 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0707
71788123|NCT02848651|143074108|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3502|TWO_SIDED|90.0|0.54|1.18|||Log Rank|||||1.18|0.54|0.3502
71788124|NCT02848651|143074115|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1783|TWO_SIDED|90.0|0.4|1.1|||Log Rank|||||1.10|0.40|0.1783
71788125|NCT02848651|143074115|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.0358|TWO_SIDED|90.0|0.23|0.85|||Log Rank|||||0.85|0.23|0.0358
71788126|NCT02848651|143074116|SUPERIORITY||Differences in Rates|13.27||||0.0326|TWO_SIDED|90.0|2.53|24.0|||Cochran-Mantel-Haenszel|||||24.00|2.53|0.0326
71788127|NCT02848651|143074116|SUPERIORITY||Difference in Rates|30.22|||<|0.0001|TWO_SIDED|90.0|14.82|45.62|||Cochran-Mantel-Haenszel|||||45.62|14.82|<0.0001
71788128|NCT02848651|143074116|SUPERIORITY||Differences in Rates|41.37|||<|0.0001|TWO_SIDED|90.0|22.13|60.61|||Cochran-Mantel-Haenszel|||||60.61|22.13|<0.0001
71837217|NCT03131648|143181211|SUPERIORITY||Risk Difference (RD)|6.0||||0.68|TWO_SIDED|95.0|-21.8|33.7||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant."|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated.|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||33.7|-21.8|0.68
71837218|NCT03131648|143181211|SUPERIORITY||Risk Difference (RD)|-9.5||||0.5|TWO_SIDED|95.0|-37.1|18.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||18.0|-37.1|0.50
71837219|NCT03131648|143181212|SUPERIORITY||Risk Difference (RD)|21.2||||0.056|TWO_SIDED|95.0|-0.2|42.6||Test not evaluated for significance. Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||42.6|-0.2|0.056
71755829|NCT02851615|143014882|SUPERIORITY|Power analyses were calculated on the PAM-13, our primary outcome measure. Analyses were conducted using the internal Monte Carlo simulation capabilities of Mplus (Version 1.20). Based on the effect size obtained from published pilot data, we expected the change in baseline/posttreatment Behavioral Activation for the SCThrive intervention group to be n2 = .14 (large effect). Based on these assumptions, the desired sample size was 54 participants (N = 27 per group) to achieve power of .80.|Mean Difference (Net)|7.75|STANDARD_ERROR_OF_MEAN|13.14||0.09|TWO_SIDED|95.0|-1.27|19.22||The threshold for statistical significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the PAM-13.||19.22|-1.27|.09
71755830|NCT02851615|143014883|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.55||0.28|TWO_SIDED|95.0|-0.19|0.66||The threshold for significance was p =.05|ANCOVA|||We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the TRAQ-5||.66|-.19|.28
71755831|NCT02851615|143014884|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.13||0.27|TWO_SIDED|95.0|-0.018|0.06||The threshold for statistical significance was p =.05|t-test, 2 sided|||We conducted a paired-samples t-test to assess for the effects of time (baseline/post-treatment) for participants (n=16) in the SCThrive intervention arm for the UNC TRxANSITION Scale.||.06|-.018|.27
71755832|NCT05764785|143014886|SUPERIORITY|||||||0.182||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.182
71788129|NCT00662363|143074138|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||independent sample t test|||Primary outcome measures chosen were between group comparisons for change on Constipation Symptom Questionnaire ratings at exit from the study. The PAC-SYM is a symptom scale where higher numbers indicate more symptoms. Change from baseline to Day 7 was calculated and larger negative differences indicated greater improvement in constipation symptoms. The PAC-QOL is a quality of life scale where higher numbers indicate better quality of life. Change from baseline to 7 days was calculated.||||<0.05
71788130|NCT01428453|143074140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|39.8||||0.133|TWO_SIDED|95.0|-12.4|92.0|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-42 and Age.|Comparison of CSF Abeta42 between placebo and rilapladib 250 mg.|||92.0|-12.4|0.133
71788131|NCT01428453|143074140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-250.3|STANDARD_ERROR_OF_MEAN|265.66||0.829|TWO_SIDED|95.0|-771.9|271.2|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-40 and Age.|Comparison of CSF Abeta40 between placebo and rilapladib 250 mg.|||271.2|-771.9|0.829
71788132|NCT01428453|143074141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.016|||||TWO_SIDED|95.0|-0.003|0.036|||||The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Ratio Abeta1-42/Abeta1-40 and Age.|||0.036|-0.003|
71837220|NCT03131648|143181212|SUPERIORITY||Risk Difference (RD)|11.7||||0.27|TWO_SIDED|95.0|-8.7|32.0||Test not evaluated for significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo."||32.0|-8.7|0.27
71837221|NCT03131648|143181215|SUPERIORITY|"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.3|26.8|||Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||26.8|13.3|<0.001
71845585|NCT01886872|143205816|SUPERIORITY||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.26|0.58||(1-sided)|Log Rank|||Arm B (Ibrutinib) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.58|0.26|<0.001
71892147|NCT04178590|143305832|SUPERIORITY|||||||0.4||||||p\<0.05|McNemar|||||||0.40
71892148|NCT04178590|143305833|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
71892149|NCT04178590|143305834|SUPERIORITY|||||||0.999||||||p\<0.05|McNemar|||||||0.999
71892150|NCT04178590|143305835|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
71892151|NCT04178590|143305836|SUPERIORITY|||||||0.453||||||p\<0.05|McNemar|||||||0.453
71892152|NCT04178590|143305837|SUPERIORITY|||||||0.625||||||p\<0.05|McNemar|||||||0.625
71892153|NCT04178590|143305838|SUPERIORITY|||||||0.999|||||||McNemar|||||||0.999
71755833|NCT05764785|143014887|SUPERIORITY|||||||0.461||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.461
71755834|NCT05764785|143014888|SUPERIORITY|||||||0.228||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.228
71755835|NCT05764785|143014889|SUPERIORITY|||||||0.295||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.295
71755836|NCT05764785|143014890|SUPERIORITY|||||||0.915||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.915
71755837|NCT05764785|143014891|SUPERIORITY|||||||0.226||||||Assumption of Sphericity was violated and Greenhouse-Geisser was above .75, thus Huynh-Feldt correction was used.|Mixed ANOVA|||||||.226
71755838|NCT02670811|143014902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71755839|NCT02670811|143014902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.|t-test, 2 sided|||||||<0.05
71755840|NCT02670811|143014903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71755841|NCT02670811|143014904|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71788133|NCT01428453|143074142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.1|STANDARD_ERROR_OF_MEAN|44.4||0.902|TWO_SIDED|95.0|-144.5|30.3|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF tau and Age.|Comparison of CSF tau between placebo and rilapladib 250 mg.|||30.3|-144.5|0.902
71788134|NCT01428453|143074142|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.46||0.892|TWO_SIDED|95.0|-7.9|1.8|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF P-tau and Age.|Comparison of P-tau between placebo and rilapladib 250 mg.|||1.8|-7.9|0.892
71788135|NCT01428453|143074143|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.167||||0.026|TWO_SIDED|95.0|0.021|0.313||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Working Memory/Executive Function Composite Score, Treatment by Visit and Baseline Working Memory/Executive Function Composite Score by Visit.|Mixed-Model Repeated Measures analysis||A positive treatment difference indicates benefit, relative to placebo.|||0.313|0.021|0.026
71788136|NCT01428453|143074144|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.256||0.828|TWO_SIDED|95.0|-0.74|0.26|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Albumin Quotient and Age.||||0.26|-0.74|0.828
71788137|NCT01428453|143074145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.9|1.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta42 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||1.2|-3.9|
71788138|NCT01428453|143074145|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||||95.0|-10.2|12.2|||Mixed-Model Repeated Measures analysis||Comparison of Abeta40 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||12.2|-10.2|
71892154|NCT04178590|143305839|SUPERIORITY|||||||0||||||p\<0.05|McNemar|||||||0.000
71755842|NCT02670811|143014905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71755843|NCT02670811|143014906|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71755844|NCT02670811|143014907|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided|||||||<0.05
71755845|NCT03714672|143014914|SUPERIORITY||Mean Difference (Final Values)|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.4|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.4|-4.8|<0.0001
71755846|NCT03714672|143014914|SUPERIORITY||Mean Difference (Final Values)|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.2|-3.8|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.||-3.8|-5.2|<0.0001
71755847|NCT03714672|143014914|SUPERIORITY||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.5|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.5|-3.9|<0.0001
71755848|NCT03714672|143014914|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.1|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.||-2.1|-3.5|<0.0001
71892155|NCT04178590|143305840|SUPERIORITY|||||||0.001||||||p\<0.05|McNemar|||||||0.001
71892156|NCT04178590|143305841|SUPERIORITY|||||||0.065||||||p\<0.05|McNemar|||||||0.065
71892157|NCT04178590|143305842|SUPERIORITY|||||||0.821||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.821
71892158|NCT04178590|143305843|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892159|NCT04178590|143305844|SUPERIORITY|||||||0.001||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.001
71892160|NCT04178590|143305845|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892161|NCT04178590|143305846|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71755849|NCT02345070|143014938|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least Square (LS) Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.05|=|0.6339|TWO_SIDED|95.0|-2.56|1.56||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg qw versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||1.56|-2.56|= 0.6339
71755850|NCT02345070|143014938|SUPERIORITY|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.04|=|0.5874|TWO_SIDED|95.0|-1.47|2.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg q2w versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was performed sequentially in the order outcome measures were reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.||2.6|-1.47|= 0.5874
71755851|NCT03081117|143014942|SUPERIORITY|||||||0.669|||||||Fisher Exact|||Analysis of Enrolled group.||||0.669
71755852|NCT03081117|143014943|SUPERIORITY||Mean Difference (Net)|-0.3914||||0.0366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 14||Analysis for Intent-to-Treat group.||||0.0366
71755853|NCT03081117|143014943|SUPERIORITY||Mean Difference (Net)|-0.5146||||0.0103|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 12||Analysis for Per Protocol group.||||0.0103
71755854|NCT03081117|143014946|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71788139|NCT01428453|143074146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|||||TWO_SIDED|95.0|-0.016|0.01|||Mixed-Model Repeated Measures analysis||The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.|||0.010|-0.016|
71671150|NCT03349060|142860123|SUPERIORITY||Difference in Percentage|5.2||||0.1888|TWO_SIDED|95.0|-1.9|12.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.4|-1.9|0.1888
71671151|NCT03349060|142860123|SUPERIORITY||Difference in Percentage|21.7|||<|0.0001|TWO_SIDED|95.0|13.0|30.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.5|13.0|<0.0001
71788140|NCT01428453|143074148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.067|||||TWO_SIDED|95.0|-0.191|0.057|||Mixed-Model Repeated Measures analysis||"The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit. A positive treatment difference indicates benefit, relative to placebo.~placebo."|||0.057|-0.191|
71671152|NCT03349060|142860123|SUPERIORITY||Difference in Percentage|13.8||||0.0071|TWO_SIDED|95.0|5.2|22.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||22.4|5.2|0.0071
71755855|NCT03081117|143014947|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71755856|NCT03081117|143014948|SUPERIORITY||Unstandardized beta coefficient|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.244|TWO_SIDED||||||Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||0.244
71755857|NCT03081117|143014949|SUPERIORITY||||||>|0.25||||||The threshold for statistical significance was p = 0.05.|Wald test, two-sided|||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71755858|NCT03081117|143014950|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71755859|NCT03081117|143014951|SUPERIORITY||||||>|0.25|||||||Wald test, two-sided|The threshold for statistical significance was p = 0.05.||Comparisons of change from W0 to W24 between treatment and placebo are based on a mixed effects regression model using a two-sided Wald test of the interaction term for treatment and time.||||>0.25
71788141|NCT01428453|143074148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138||||0.982|TWO_SIDED|95.0|0.01|0.267||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Overall Composite Score, Treatment by Visit and Baseline Overall Composite Score by Visit.|Mixed-Model Repeated Measures analysis|The probability (effect size) for change from Baseline in CogState battery overall composite score \>0 is presented.|A positive treatment difference indicates benefit, relative to placebo. Comparison of overall composite score between placebo and rilapladib 250 mg at Week 24.|||0.267|0.010|0.982
71788142|NCT01428453|143074149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.063|||||TWO_SIDED|95.0|-0.257|0.13|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 12. A positive treatment difference indicates benefit, relative to placebo.|||0.130|-0.257|
71755860|NCT03081117|143014952|SUPERIORITY||Mean Difference (Net)|0.0031351||||0.366|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.366
71755861|NCT03081117|143014952|SUPERIORITY||Mean Difference (Net)|0.0025586||||0.505|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees fo freedom = 10||Analysis for Per Protocol group.||||0.505
71755862|NCT03081117|143014953|SUPERIORITY||Mean Difference (Net)|0.00000061||||0.98|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 13||Analysis for All Available group (participants who had both Baseline and Week 24 scans).||||0.98
71755863|NCT03081117|143014953|SUPERIORITY||Mean Difference (Net)|-0.0000054||||0.86|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of freedom = 10||Analysis for Per Protocol group.||||0.86
71788143|NCT01428453|143074149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.13|0.269|||Mixed-Model Repeated Measures analysis|The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit.|Comparison of attention composite score between placebo and rilapladib 250 mg at Week 24. A positive treatment difference indicates benefit, relative to placebo.|||0.269|-0.130|
71788144|NCT02607033|143074150|OTHER|Wilxocon signed Rank test||||||0.028|||||||Wilxocon signed Rank test|||Wilxocon signed Rank test to compare pre to post onset of pain time in the Exercise + Weight loss group. Due to low sample size were unable to compare changes between the Exercise + Weight Loss group and the Exercise only groups.||||0.028
71788145|NCT04203238|143074159|SUPERIORITY||Median Difference (Final Values)|0.89|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71788146|NCT01134783|143074172|SUPERIORITY_OR_OTHER|||||||0.707|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.707
71788147|NCT01134783|143074173|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED|||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic|||||||0.049
71788148|NCT04346537|143074180|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
71788149|NCT04346537|143074181|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||||||< 0.001
71837222|NCT03131648|143181216|SUPERIORITY||Risk Difference (RD)|10.3|||<|0.001|TWO_SIDED|95.0|6.4|14.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||14.1|6.4|<0.001
71755864|NCT00321620|143014970|NON_INFERIORITY_OR_EQUIVALENCE|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82||||0.0002||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)|||0.95|0.71|0.0002
71755865|NCT00321620|143014971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0085||95.0|0.71|0.95|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.95|0.71|0.0085
71788150|NCT04346537|143074182|OTHER|Two-one sided t-tests (TOST) -- the 90% confidence interval was required to be contained with 300 and 1300 ohms.|||||<|0.001|||||||Two one-sided t-tests|||||||< 0.001
71788151|NCT02423577|143074241|SUPERIORITY||Risk Ratio (RR)|1.14||||0.1436|TWO_SIDED|90.0|0.98|1.31|||Chi-squared|||||1.31|0.98|0.1436
71788152|NCT02392247|143074242|SUPERIORITY_OR_OTHER||Slope|0.34|||<|0.001|TWO_SIDED|95.0|0.26|0.44||This study was not designed to determine which method is 'superior'.Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming Regression||Slope measured deviation from 1:1 concordance between SEER and TEG with TEG measurement as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)||0.44|0.26|<0.001
71788153|NCT02392247|143074243|SUPERIORITY_OR_OTHER||Slope|3.1|||<|0.001|TWO_SIDED|95.0|2.9|3.4||This study was not designed to determine which method is 'superior'. Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming regression|Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 'bleeding' patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )||3.4|2.9|<0.001
71788154|NCT03010254|143074244|SUPERIORITY||Least Squares Mean Difference|-0.138|STANDARD_ERROR_OF_MEAN|0.021|<|0.001|TWO_SIDED|95.0|-0.18|-0.097||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.097|-0.180|<0.001
71837223|NCT03131648|143181217|SUPERIORITY||Difference of least square means|-6.4|||<|0.001|TWO_SIDED|95.0|-8.8|-4.1||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-4.1|-8.8|<0.001
71755866|NCT00321620|143014972|SUPERIORITY_OR_OTHER||Rate ratio|0.82||||0.0085||95.0|0.71|0.94|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).|||0.94|0.71|0.0085
71755867|NCT00423579|143014976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.5||||0||95.0|-18.9|-10.1|||Student's t test for independent data||Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe \[EZ\]/Simvastatin \[S\] \[10/20mg\] + S \[placebo\] group minus the EZ/S \[10mg/placebo\] + S \[40mg\] group)|||-10.1|-18.9|0.0000
71755868|NCT02392637|143014977|SUPERIORITY|||||||0.62|||||||Log Rank|||||||0.62
71755869|NCT02392637|143014978|SUPERIORITY|||||||0.39|||||||Log Rank|||||||0.39
71755870|NCT03773978|143014981|SUPERIORITY||Hazard Ratio (HR)|0.241|||<|0.001|TWO_SIDED|95.0|0.128|0.453|||Log Rank|||||0.453|0.128|<0.001
71755871|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|2.72||||0.052|TWO_SIDED|95.0|0.99|7.46|||Regression, Logistic|||at week 16||7.46|0.99|0.052
71755872|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.28|||Regression, Logistic|||at week 20||8.28|1.60|0.002
71755873|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|4.34|||<|0.001|TWO_SIDED|95.0|2.0|9.41|||Regression, Logistic|||at week 24||9.41|2.00|<0.001
71755874|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|3.37||||0.001|TWO_SIDED|95.0|1.62|7.01|||Regression, Logistic|||at week 28||7.01|1.62|0.001
71755875|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|3.0||||0.002|TWO_SIDED|95.0|1.48|6.07|||Regression, Logistic|||at week 32||6.07|1.48|0.002
71755876|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|3.25|||<|0.001|TWO_SIDED|95.0|1.62|6.52|||Regression, Logistic|||at week 36||6.52|1.62|<0.001
71755877|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|3.7|||<|0.001|TWO_SIDED|95.0|1.85|7.41|||Regression, Logistic|||at week 40||7.41|1.85|<0.001
71755878|NCT03773978|143014982|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.65|6.5|||Regression, Logistic|||at week 44||6.50|1.65|<0.001
71671153|NCT03349060|142860123|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.8|38.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.7|19.8|<0.0001
71755879|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|1.25||||0.568|TWO_SIDED|95.0|0.59|2.65|||Regression, Logistic|||at week 16||2.65|0.59|0.568
71837224|NCT03131648|143181218|SUPERIORITY||Risk Difference (RD)|5.7||||0.007|TWO_SIDED|95.0|2.5|8.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered nonresponders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||8.9|2.5|0.007
71755880|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|2.92||||0.004|TWO_SIDED|95.0|1.4|6.09|||Regression, Logistic|||at week 20||6.09|1.40|0.004
71755881|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.001|TWO_SIDED|95.0|2.1|9.15|||Regression, Logistic|||at week 24||9.15|2.10|<0.001
71755882|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|3.09||||0.002|TWO_SIDED|95.0|1.51|6.32|||Regression, Logistic|||at week 28||6.32|1.51|0.002
71755883|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|2.99||||0.003|TWO_SIDED|95.0|1.47|6.11|||Regression, Logistic|||at week 32||6.11|1.47|0.003
71755884|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|2.84||||0.003|TWO_SIDED|95.0|1.44|5.6|||Regression, Logistic|||at week 36||5.60|1.44|0.003
71755885|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.74|6.97|||Regression, Logistic|||at week 40||6.97|1.74|<0.001
71755886|NCT03773978|143014983|SUPERIORITY||Odds Ratio (OR)|2.87||||0.002|TWO_SIDED|95.0|1.46|5.66|||Regression, Logistic|||at week 44||5.66|1.46|0.002
71755887|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Regression, Logistic|||at week 16||1.87|0.52|0.972
71755888|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|2.47||||0.008|TWO_SIDED|95.0|1.27|4.81|||Regression, Logistic|||at week 20||4.81|1.27|0.008
71755889|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|2.57||||0.005|TWO_SIDED|95.0|1.33|4.97|||Regression, Logistic|||at week 24||4.97|1.33|0.005
71755890|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|3.06|||<|0.001|TWO_SIDED|95.0|1.57|5.94|||Regression, Logistic|||at week 28||5.94|1.57|<0.001
71755891|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|2.42||||0.009|TWO_SIDED|95.0|1.25|4.71|||Regression, Logistic|||at week 32||4.71|1.25|0.009
71755892|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|2.8||||0.003|TWO_SIDED|95.0|1.43|5.47|||Regression, Logistic|||at week 36||5.47|1.43|0.003
71755893|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|2.93||||0.002|TWO_SIDED|95.0|1.47|5.83|||Regression, Logistic|||at week 40||5.83|1.47|0.002
71755894|NCT03773978|143014984|SUPERIORITY||Odds Ratio (OR)|1.93||||0.052|TWO_SIDED|95.0|0.99|3.74|||Regression, Logistic|||at week 44||3.74|0.99|0.052
71755895|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|1.35||||0.409|TWO_SIDED|95.0|0.66|2.75|||Regression, Logistic|||at week 16||2.75|0.66|0.409
71755896|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|2.13||||0.03|TWO_SIDED|95.0|1.07|4.23|||Regression, Logistic|||at week 20||4.23|1.07|0.030
71755897|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|2.36||||0.022|TWO_SIDED|95.0|1.13|4.92|||Regression, Logistic|||at week 24||4.92|1.13|0.022
71755898|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|2.05||||0.04|TWO_SIDED|95.0|1.03|4.08|||Regression, Logistic|||at week 28||4.08|1.03|0.040
71755899|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|2.13||||0.032|TWO_SIDED|95.0|1.07|4.24|||Regression, Logistic|||at week 32||4.24|1.07|0.032
71755900|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|1.71||||0.132|TWO_SIDED|95.0|0.85|3.42|||Regression, Logistic|||at week 36||3.42|0.85|0.132
71845586|NCT01886872|143205816|SUPERIORITY||Hazard Ratio (HR)|0.38|||<|0.001|TWO_SIDED|95.0|0.25|0.59||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm A (Rituximab, Bendamustine Hydrochloride)||0.59|0.25|<0.001
71845587|NCT01886872|143205816|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.49|TWO_SIDED|95.0|0.62|1.62||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm B (Ibrutinib)||1.62|0.62|0.49
71755901|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|2.02||||0.05|TWO_SIDED|95.0|1.0|4.1|||Regression, Logistic|||at week 40||4.10|1.00|0.050
71755902|NCT03773978|143014985|SUPERIORITY||Odds Ratio (OR)|2.32||||0.019|TWO_SIDED|95.0|1.15|4.71|||Regression, Logistic|||at week 44||4.71|1.15|0.019
71755903|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|0.8||||0.62|TWO_SIDED|95.0|0.33|1.92|||Regression, Logistic|||at week 16||1.92|0.33|0.620
71755904|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|1.3||||0.492|TWO_SIDED|95.0|0.61|2.78|||Regression, Logistic|||at week 20||2.78|0.61|0.492
71755905|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|1.17||||0.715|TWO_SIDED|95.0|0.5|2.75|||Regression, Logistic|||at week 24||2.75|0.50|0.715
71755906|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|1.4||||0.384|TWO_SIDED|95.0|0.66|2.99|||Regression, Logistic|||at week 28||2.99|0.66|0.384
71755907|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|1.47||||0.311|TWO_SIDED|95.0|0.7|3.1|||Regression, Logistic|||at week 32||3.10|0.70|0.311
71755908|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|1.58||||0.231|TWO_SIDED|95.0|0.75|3.34|||Regression, Logistic|||at week 36||3.34|0.75|0.231
71755909|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|1.82||||0.129|TWO_SIDED|95.0|0.84|3.95|||Regression, Logistic|||at week 40||3.95|0.84|0.129
71755910|NCT03773978|143014986|SUPERIORITY||Odds Ratio (OR)|2.23||||0.043|TWO_SIDED|95.0|1.02|4.84|||Regression, Logistic|||at week 44||4.84|1.02|0.043
71755911|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|1.1||||0.853|TWO_SIDED|95.0|0.4|2.98|||Regression, Logistic|||at week 16||2.98|0.40|0.853
71755912|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|0.7||||0.432|TWO_SIDED|95.0|0.29|1.71|||Regression, Logistic|||at week 20||1.71|0.29|0.432
71755913|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|0.98||||0.96|TWO_SIDED|95.0|0.41|2.31|||Regression, Logistic|||at week 24||2.31|0.41|0.960
71755914|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|1.71||||0.215|TWO_SIDED|95.0|0.73|4.01|||Regression, Logistic|||at week 28||4.01|0.73|0.215
71788155|NCT03010254|143074246|NON_INFERIORITY|Non-inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.037|STANDARD_ERROR_OF_MEAN|0.0115|||ONE_SIDED|97.5||0.059|||||Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.|||0.059||
71755915|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|1.8||||0.173|TWO_SIDED|95.0|0.77|4.22|||Regression, Logistic|||at week 32||4.22|0.77|0.173
71755916|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|1.46||||0.367|TWO_SIDED|95.0|0.64|3.33|||Regression, Logistic|||at week 36||3.33|0.64|0.367
71755917|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|1.9||||0.162|TWO_SIDED|95.0|0.77|4.67|||Regression, Logistic|||at week 40||4.67|0.77|0.162
71755918|NCT03773978|143014987|SUPERIORITY||Odds Ratio (OR)|1.96||||0.113|TWO_SIDED|95.0|0.85|4.5|||Regression, Logistic|||at week 44||4.50|0.85|0.113
71755919|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|0.8||||0.511|TWO_SIDED|95.0|0.42|1.55|||Regression, Logistic|||at week 16||1.55|0.42|0.511
71755920|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.64||||0.145|TWO_SIDED|95.0|0.84|3.2|||Regression, Logistic|||at week 20||3.20|0.84|0.145
71755921|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.38||||0.349|TWO_SIDED|95.0|0.7|2.72|||Regression, Logistic|||at week 24||2.72|0.70|0.349
71755922|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.63||||0.167|TWO_SIDED|95.0|0.82|3.25|||Regression, Logistic|||at week 28||3.25|0.82|0.167
71755923|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.55||||0.212|TWO_SIDED|95.0|0.78|3.07|||Regression, Logistic|||at week 32||3.07|0.78|0.212
71755924|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.21||||0.577|TWO_SIDED|95.0|0.62|2.39|||Regression, Logistic|||at week 36||2.39|0.62|0.577
71755925|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.51||||0.225|TWO_SIDED|95.0|0.78|2.95|||Regression, Logistic|||at week 40||2.95|0.78|0.225
71755926|NCT03773978|143014988|SUPERIORITY||Odds Ratio (OR)|1.96||||0.055|TWO_SIDED|95.0|0.98|3.9|||Regression, Logistic|||at week 44||3.90|0.98|0.055
71755927|NCT03773978|143014990|SUPERIORITY||LS Mean difference|-4.33|STANDARD_ERROR_OF_MEAN|1.328||0.001|TWO_SIDED|95.0|-6.95|-1.7|||ANCOVA|||||-1.70|-6.95|0.001
71755928|NCT03773978|143014991|SUPERIORITY||LS Mean difference|-12.97|STANDARD_ERROR_OF_MEAN|4.262||0.003|TWO_SIDED|95.0|-21.39|-4.55|||ANCOVA|||||-4.55|-21.39|0.003
71755929|NCT03773978|143014992|SUPERIORITY||LS Mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.526||0.574|TWO_SIDED|95.0|-2.62|1.91|||ANCOVA|||||1.91|-2.62|0.574
71755930|NCT03773978|143014993|SUPERIORITY||LS Mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.348||0.208|TWO_SIDED|95.0|-0.26|1.15|||ANCOVA|||||1.15|-0.26|0.208
71755931|NCT03773978|143014994|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.438||0.019|TWO_SIDED|95.0|-1.98|-0.19|||ANCOVA|||||-0.19|-1.98|0.019
71755932|NCT04659863|143015001|OTHER||Mean Difference (Net)|-33.25|||||TWO_SIDED|95.0|-59.17|-7.34||||||||-7.34|-59.17|
71755933|NCT04672239|143015023|SUPERIORITY||Mean Difference (Final Values)|7.3341||||0.0219|TWO_SIDED|95.0|1.0734|13.5948||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||13.5948|1.0734|0.0219
71755934|NCT04672239|143015023|SUPERIORITY||Mean Difference (Final Values)|8.7775||||0.0072|TWO_SIDED|95.0|2.407|15.148||We used hierarchical linear mixed models with maximum likelihood estimation of all available longitudinal data to handle missing data, then used a planned, pairwise comparison to test for end-of-treatment group differences.|Mixed Models Analysis||Model-estimated difference for the pairwise group difference at week 6 post-quit (end-of-treatment).|This proof-of-concept RCT was powered to detect an effect size of d=0.50 between SiS3 and either of the two control groups. Using SAS PROC POWER, it was determined that a sample size of n=64 per group would be needed to detect this effect in a 2-sided t-test with p=.05. Assuming a retention rate of 85%, it was determined that one needed to enroll n=75 per group in order to retain n=64 by end of treatment.||15.1480|2.4070|0.0072
71892162|NCT04178590|143305847|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71755935|NCT04672239|143015024|SUPERIORITY||Odds Ratio (OR)|1.5072||||0.2259|TWO_SIDED|95.0|0.7759|2.9281|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the QG app treatment at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the QuitGuide app treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., end-of-treatment).||2.9281|0.7759|0.2259
71755936|NCT04672239|143015024|SUPERIORITY||Odds Ratio (OR)|1.963||||0.0579|TWO_SIDED|95.0|0.9776|3.9415|||Generalized Linear Model|We used a Generalized Linear Model with binomial distribution (abstinent vs. smoking) and logit link with repeated measures over time.|The odds ratio compares the SiS app treatment to the CtA pamphlet at week 6 post-quit (end-of-treatment).|This was an exploratory aim, so no power analysis was conducted. We hypothesized, that the 30-day point prevalence smoking cessation prevalence would be higher in the SiS app treatment compared to the Clearing the Air pamphlet treatment. Participants with missing data were assumed to be smoking. We modeled all available data over time and present the cross-sectional group difference test at week 6 post quit (i.e., post-treatment).||3.9415|0.9776|0.0579
71755937|NCT04672239|143015025|SUPERIORITY||Wilcoxon Z|0.401||||0.9152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app treatment vs. QuitGuide app treatment at week 6 post-quit (end-of-treatment)|||||0.9152
71671154|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71755938|NCT04672239|143015025|SUPERIORITY||Wilcoxon Z|1.372||||0.3557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|Pairwise comparison, SiS app treatment vs. CTA pamphlet at week 6 post-quit (end-of-treatment)|||||0.3557
71755939|NCT04672239|143015026|SUPERIORITY||Mean Difference (Final Values)|0.2936||||0.7469|TWO_SIDED|95.0|-1.4983|2.0856||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the QuitGuide treatment as control (Contrast coding SiS 1, QG -1)|||2.0856|-1.4983|0.7469
71755940|NCT04672239|143015026|SUPERIORITY||Mean Difference (Final Values)|1.2569||||0.1747|TWO_SIDED|95.0|-0.5628|3.0766||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided||Comparison of SiS app treatment to the Clearing the Air pamphlet treatment as control (Contrast coding SiS 1, CtA -1)|||3.0766|-0.5628|0.1747
71755941|NCT04672239|143015027|SUPERIORITY||Wilcoxon Z|1.9255||||0.1315|TWO_SIDED|||||p-values were not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method||||||0.1315
71788156|NCT03010254|143074247|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.0216|<|0.001|TWO_SIDED|95.0|-0.133|-0.048||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.048|-0.133|<0.001
71788157|NCT03010254|143074248|OTHER||Mean difference in depth of focus|0.52|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Mean difference in depth of focus (DFT015 - SN60WF)|||||
71788158|NCT03010254|143074249|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.0551|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|Without glare|||-0.287|
71788159|NCT03010254|143074249|NON_INFERIORITY|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.181|STANDARD_ERROR_OF_MEAN|0.0541|||ONE_SIDED|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|With glare|||-0.287|
71788160|NCT03010254|143074250|SUPERIORITY||Difference in percentage|20.2|||||TWO_SIDED|95.0|8.77|31.04|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||31.04|8.77|
71837225|NCT03131648|143181219|SUPERIORITY||Risk Difference (RD)|14.1|||<|0.001|TWO_SIDED|95.0|8.6|19.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||19.6|8.6|<0.001
71892163|NCT04178590|143305848|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71671155|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with event was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71755942|NCT04672239|143015027|SUPERIORITY||Wilcoxon Z|1.401||||0.3403|TWO_SIDED|||||the p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|Pairwise Two-Sided Multiple Comparison Analysis Dwass, Steel, Critchlow-Fligner Method|SiS app vs. Clearing the Air pamphlet|||||0.3403
71755943|NCT04672239|143015028|SUPERIORITY||Mean Difference (Final Values)|0.2289||||0.0429|TWO_SIDED|95.0|0.007364|0.4505||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app|0.4505|0.007364|0.0429
71755944|NCT04672239|143015028|SUPERIORITY||Mean Difference (Final Values)|0.1609||||0.16|TWO_SIDED|95.0|-0.06415|0.386||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet|0.3860|-0.06415|0.1600
71788161|NCT03010254|143074251|SUPERIORITY||Percent difference|21.7|||||TWO_SIDED|95.0|7.92|35.06|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||35.06|7.92|
71788162|NCT01404325|143074252|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71788163|NCT02144233|143074281|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71788164|NCT01529346|143074318|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.38|0.22||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.22|-0.38|
71837226|NCT03131648|143181220|SUPERIORITY||Difference of least square means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.4||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.4|-1.4|<0.001
71892164|NCT04178590|143305849|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
71892165|NCT04178590|143305850|SUPERIORITY|||||||0.671||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.671
71892166|NCT04178590|143305851|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71755945|NCT04672239|143015029|SUPERIORITY||Mean Difference (Final Values)|0.152||||0.1996|TWO_SIDED|95.0|-0.08092|0.3848||p-value is not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QG app|0.3848|-0.08092|0.1996
71755946|NCT04672239|143015029|SUPERIORITY||Mean Difference (Final Values)|0.292||||0.0154|TWO_SIDED|95.0|0.05636|0.5276||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|0.5276|0.05636|0.0154
71755947|NCT04672239|143015030|SUPERIORITY||Mean Difference (Final Values)|2.6255||||0.2988|TWO_SIDED|95.0|-2.3458|7.5968||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. QuitGuide app (control)|7.5968|-2.3458|0.2988
71755948|NCT04672239|143015030|SUPERIORITY||Mean Difference (Final Values)|3.9277||||0.1251|TWO_SIDED|95.0|-1.1015|8.9569||p-value was not adjusted for multiple comparisons|t-test, 2 sided||||SiS app vs. CtA pamphlet (control)|8.9569|-1.1015|0.1251
71755949|NCT04672239|143015031|SUPERIORITY||Wilcoxon Z|-0.8096||||0.4182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4182
71755950|NCT04672239|143015032|SUPERIORITY||Wilcoxon Z|1.909||||0.0563|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0563
71755951|NCT04672239|143015033|SUPERIORITY||Mean Difference (Final Values)|0.1106||||0.5018|TWO_SIDED|95.0|-0.2143|0.4354|||t-test, 2 sided|||||0.4354|-0.2143|0.5018
71755952|NCT04672239|143015034|SUPERIORITY||Mean Difference (Final Values)|0.1406||||0.4246|TWO_SIDED|95.0|-0.2068|0.488|||t-test, 2 sided|||||0.4880|-0.2068|0.4246
71755953|NCT04672239|143015035|SUPERIORITY||Mean Difference (Final Values)|2.4296||||0.4078|TWO_SIDED|95.0|-3.3597|8.2188|||t-test, 2 sided||SiS app vs. QG (control)|||8.2188|-3.3597|0.4078
71755954|NCT05565742|143015080|SUPERIORITY||LS Mean difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|8.82|<|0.001|TWO_SIDED|95.0|-55.8|-20.6|||Mixed Models Analysis|||||-20.6|-55.8|<0.001
71755955|NCT05565742|143015080|SUPERIORITY||LS Mean difference (Final Values)|-75.2|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-80.4|-68.5|||Mixed Models Analysis|||||-68.5|-80.4|<0.001
71755956|NCT05565742|143015080|SUPERIORITY||LS Mean difference (Final Values)|-93.9|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-95.1|-92.5|||Mixed Models Analysis|||||-92.5|-95.1|<0.001
71755957|NCT05565742|143015081|SUPERIORITY||LS Mean difference (Final Values)|-38.9|STANDARD_ERROR_OF_MEAN|9.43||0.002|TWO_SIDED|95.0|-54.9|-17.2|||Mixed Models Analysis|||||-17.2|-54.9|0.002
71755958|NCT05565742|143015081|SUPERIORITY||LS Mean difference (Final Values)|-77.4|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-82.4|-71.1|||Mixed Models Analysis|||||-71.1|-82.4|<0.001
71755959|NCT05565742|143015081|SUPERIORITY||LS Mean difference (Final Values)|-95.0|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-96.1|-93.6|||Mixed Models Analysis|||||-93.6|-96.1|<0.001
71755960|NCT05565742|143015081|SUPERIORITY||LS Mean difference (Final Values)|-76.8|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-81.9|-70.2|||Mixed Models Analysis|||||-70.2|-81.9|<0.001
71755961|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|112.03||||0.001|TWO_SIDED|95.0|6.35|1975.13|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1975.13|6.35|0.001
71755962|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|2762.52|||<|0.001|TWO_SIDED|95.0|142.74|53463.34|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||53463.34|142.74|<0.001
71755963|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|50904.09|||<|0.001|TWO_SIDED|95.0|1700.95|1523398.1|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 60||1523398.10|1700.95|<0.001
71755964|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|27.94||||0.026|TWO_SIDED|95.0|1.48|527.74|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||527.74|1.48|0.026
71755965|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|309.36|||<|0.001|TWO_SIDED|95.0|17.99|5320.81|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||5320.81|17.99|<0.001
71755966|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|3060.16|||<|0.001|TWO_SIDED|95.0|166.84|56127.55|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 180||56127.55|166.84|<0.001
71755967|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|32.91||||0.021|TWO_SIDED|95.0|1.7|635.94|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||635.94|1.70|0.021
71755968|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|579.62|||<|0.001|TWO_SIDED|95.0|31.48|10673.41|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||10673.41|31.48|<0.001
71755969|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|14659.81|||<|0.001|TWO_SIDED|95.0|646.35|332498.98|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 60||332498.98|646.35|<0.001
71755970|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|15.94||||0.071|TWO_SIDED|95.0|0.79|321.21|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||321.21|0.79|0.071
71755971|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|86.32||||0.002|TWO_SIDED|95.0|5.07|1468.36|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||1468.36|5.07|0.002
71755972|NCT05565742|143015082|SUPERIORITY||Odds Ratio (OR)|956.84|||<|0.001|TWO_SIDED|95.0|55.75|16422.76|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 180||16422.76|55.75|<0.001
71755973|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|32.05|||<|0.001|TWO_SIDED|95.0|5.36|191.58|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||191.58|5.36|<0.001
71755974|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|602.39|||<|0.001|TWO_SIDED|95.0|95.36|3805.22|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||3805.22|95.36|<0.001
71755975|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|6953.37|||<|0.001|TWO_SIDED|95.0|527.56|91646.24|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||91646.24|527.56|<0.001
71755976|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|347.76|||<|0.001|TWO_SIDED|95.0|57.46|2104.62|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 240||2104.62|57.46|<0.001
71755977|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|54.99||||0.007|TWO_SIDED|95.0|2.98|1015.84|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||1015.84|2.98|0.007
71755978|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|363.15|||<|0.001|TWO_SIDED|95.0|20.83|6332.68|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6332.68|20.83|<0.001
71671156|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with event was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
71671157|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
71671158|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|4.6||||0.0592|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0592
71671159|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
71671160|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|7.0||||0.019|TWO_SIDED|95.0|1.7|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.3|1.7|0.0190
71671161|NCT03349060|142860124|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
71755979|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|2953.53|||<|0.001|TWO_SIDED|95.0|150.95|57790.71|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||57790.71|150.95|<0.001
71755980|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|375.16|||<|0.001|TWO_SIDED|95.0|21.46|6571.66|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 360||6571.66|21.46|<0.001
71755981|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|16.43||||0.068|TWO_SIDED|95.0|0.81|331.69|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||331.69|0.81|0.068
71788165|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.2|0.39||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.39|-0.20|
71788166|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.28|0.32||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.32|-0.28|
71755982|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|84.97||||0.002|TWO_SIDED|95.0|4.99|1447.48|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1447.48|4.99|0.002
71755983|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|594.66|||<|0.001|TWO_SIDED|95.0|33.99|10405.09|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||10405.09|33.99|<0.001
71755984|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|110.17||||0.001|TWO_SIDED|95.0|6.47|1875.77|||Regression, Logistic|||Lp(a) \<125 nmol/L: Day 540||1875.77|6.47|0.001
71755985|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|11.61||||0.01|TWO_SIDED|95.0|1.81|74.29|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||74.29|1.81|0.010
71788167|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-0.41|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.41|
71892167|NCT04178590|143305852|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71671162|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|24.0|||<|0.0001|TWO_SIDED|95.0|13.9|34.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.1|13.9|<0.0001
71671163|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|45.1|||<|0.0001|TWO_SIDED|95.0|34.7|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|34.7|<0.0001
71755986|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|233.25|||<|0.001|TWO_SIDED|95.0|39.92|1362.79|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||1362.79|39.92|<0.001
71813239|NCT01392300|143128997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
71813240|NCT01392300|143128998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.003|TWO_SIDED|95.0|0.1|0.5|||ANCOVA|||||0.5|0.1|0.003
71813241|NCT01392300|143128999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.28|||<|0.001|TWO_SIDED|95.0|2.43|7.52|||Regression, Logistic|||||7.52|2.43|<0.001
71813242|NCT01392300|143129000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.56|4.63|||Regression, Logistic|||||4.63|1.56|<0.001
71813243|NCT01392300|143129001|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.48||||0.004|TWO_SIDED|95.0|1.33|4.61|||Regression, Logistic|||||4.61|1.33|0.004
71813244|NCT01392300|143129002|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.76|5.57|||Regression, Logistic|||||5.57|1.76|<0.001
71671164|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|33.5|||<|0.0001|TWO_SIDED|95.0|21.6|45.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.4|21.6|<0.0001
71671165|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|52.7|||<|0.0001|TWO_SIDED|95.0|41.2|64.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.2|41.2|<0.0001
71671166|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|34.1|||<|0.0001|TWO_SIDED|95.0|21.9|46.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.3|21.9|<0.0001
71755987|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|3087.58|||<|0.001|TWO_SIDED|95.0|331.26|28778.1|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||28778.10|331.26|<0.001
71755988|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|144.58|||<|0.001|TWO_SIDED|95.0|25.2|829.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 240||829.42|25.20|<0.001
71755989|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|11.16||||0.125|TWO_SIDED|95.0|0.51|243.85|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||243.85|0.51|0.125
71755990|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|148.3|||<|0.001|TWO_SIDED|95.0|8.64|2546.89|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2546.89|8.64|<0.001
71755991|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|1431.38|||<|0.001|TWO_SIDED|95.0|77.76|26349.86|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||26349.86|77.76|<0.001
71755992|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|147.78|||<|0.001|TWO_SIDED|95.0|8.6|2538.95|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 360||2538.95|8.60|<0.001
71755993|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|1.99||||0.733|TWO_SIDED|95.0|0.04|104.02|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||104.02|0.04|0.733
71788168|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.44||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.32|
71788169|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.01|0.77||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.01|
71755994|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|34.28||||0.015|TWO_SIDED|95.0|1.98|594.46|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||594.46|1.98|0.015
71755995|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|159.77|||<|0.001|TWO_SIDED|95.0|9.4|2716.42|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||2716.42|9.40|<0.001
71755996|NCT05565742|143015083|SUPERIORITY||Odds Ratio (OR)|37.98||||0.013|TWO_SIDED|95.0|2.19|659.75|||Regression, Logistic|||Lp(a) \<75 nmol/L: Day 540||659.75|2.19|0.013
71755997|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-47.4|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-59.9|-30.9|||Mixed Models Analysis|||Baseline to Day 60||-30.9|-59.9|<0.001
71755998|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-80.9|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-84.7|-76.1|||Mixed Models Analysis|||Baseline to Day 60||-76.1|-84.7|<0.001
71755999|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
71756000|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-95.5|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|-96.3|-94.5|||Mixed Models Analysis|||Baseline to Day 60||-94.5|-96.3|<0.001
71756001|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|11.1||0.019|TWO_SIDED|95.0|-50.6|-6.2|||Mixed Models Analysis|||Baseline to Day 180||-6.2|-50.6|0.019
71756002|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-66.0|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-73.8|-55.9|||Mixed Models Analysis|||Baseline to Day 180||-55.9|-73.8|<0.001
71756003|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
71788170|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.22|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|-0.22|
71671167|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|52.9|||<|0.0001|TWO_SIDED|95.0|41.3|64.6|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||64.6|41.3|<0.0001
71756004|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-90.7|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|-92.6|-88.3|||Mixed Models Analysis|||Baseline to Day 180||-88.3|-92.6|<0.001
71756005|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-47.3|STANDARD_ERROR_OF_MEAN|8.25|<|0.001|TWO_SIDED|95.0|-61.3|-28.3|||Mixed Models Analysis|||Baseline to Day 240||-28.3|-61.3|<0.001
71813245|NCT01392300|143129003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.021|TWO_SIDED|95.0|1.1|3.34|||Regression, Logistic|||||3.34|1.10|0.021
71813246|NCT01392300|143129004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.32|5.05|||Regression, Logistic|||||5.05|1.32|0.006
71813247|NCT01392300|143129005|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.06|6.72|||Regression, Logistic|||||6.72|2.06|<0.001
71756006|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-88.1|-80.3|||Mixed Models Analysis|||Baseline to Day 240||-80.3|-88.1|<0.001
71756007|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-96.8|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-97.4|-95.9|||Mixed Models Analysis|||Baseline to Day 240||-95.9|-97.4|<0.001
71756008|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-84.7|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-87.9|-80.8|||Mixed Models Analysis|||Baseline to Day 240||-80.8|-87.9|<0.001
71756009|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|11.45||0.029|TWO_SIDED|95.0|-49.4|-3.6|||Mixed Models Analysis|||Baseline to Day 360||-3.6|-49.4|0.029
71756010|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-67.4|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-74.9|-57.6|||Mixed Models Analysis|||Baseline to Day 360||-57.6|-74.9|<0.001
71756011|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-91.0|STANDARD_ERROR_OF_MEAN|1.11|<|0.001|TWO_SIDED|95.0|-92.9|-88.5|||Mixed Models Analysis|||Baseline to Day 360||-88.5|-92.9|<0.001
71756012|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-67.8|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-74.8|-59.0|||Mixed Models Analysis|||Baseline to Day 360||-59.0|-74.8|<0.001
71756013|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-19.7|STANDARD_ERROR_OF_MEAN|10.45||0.093|TWO_SIDED|95.0|-37.8|3.7|||Mixed Models Analysis|||Baseline to Day 540||3.7|-37.8|0.093
71756014|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-45.8|STANDARD_ERROR_OF_MEAN|5.76|<|0.001|TWO_SIDED|95.0|-56.0|-33.2|||Mixed Models Analysis|||Baseline to Day 540||-33.2|-56.0|<0.001
71788171|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.24|1.07||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.07|0.24|
71756015|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-74.2|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-78.8|-68.5|||Mixed Models Analysis|||Baseline to Day 540||-68.5|-78.8|<0.001
71756016|NCT05565742|143015084|SUPERIORITY||LS Mean difference (Final Values)|-53.4|STANDARD_ERROR_OF_MEAN|4.67|<|0.001|TWO_SIDED|95.0|-61.7|-43.3|||Mixed Models Analysis|||Baseline to Day 540||-43.3|-61.7|<0.001
71756017|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|3.74||0.01|TWO_SIDED|95.0|-17.5|-2.6|||Mixed Models Analysis|||Baseline to Day 60||-2.6|-17.5|0.010
71756018|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|3.02|<|0.001|TWO_SIDED|95.0|-17.7|-5.8|||Mixed Models Analysis|||Baseline to Day 60||-5.8|-17.7|<0.001
71788172|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.37|0.42||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.42|-0.37|
71892168|NCT04178590|143305853|SUPERIORITY|||||||0|||||||Wilcoxon (Mann-Whitney)|||||||0.000
71756019|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
71756020|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-19.0|-8.8|||Mixed Models Analysis|||Baseline to Day 60||-8.8|-19.0|<0.001
71756021|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.27||0.068|TWO_SIDED|95.0|-16.2|0.6|||Mixed Models Analysis|||Baseline to Day 180||0.6|-16.2|0.068
71756022|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|3.4||0.003|TWO_SIDED|95.0|-17.1|-3.8|||Mixed Models Analysis|||Baseline to Day 180||-3.8|-17.1|0.003
71756023|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
71756024|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-19.3|-7.9|||Mixed Models Analysis|||Baseline to Day 180||-7.9|-19.3|<0.001
71756025|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|3.93||0.026|TWO_SIDED|95.0|-16.7|-1.2|||Mixed Models Analysis|||Baseline to Day 240||-1.2|-16.7|0.026
71756026|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-21.1|-9.3|||Mixed Models Analysis|||Baseline to Day 240||-9.3|-21.1|<0.001
71756027|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-21.0|-9.6|||Mixed Models Analysis|||Baseline to Day 240||-9.6|-21.0|<0.001
71756028|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-10.6|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-16.3|-4.4|||Mixed Models Analysis|||Baseline to Day 240||-4.4|-16.3|<0.001
71756029|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|4.21||0.111|TWO_SIDED|95.0|-14.9|1.7|||Mixed Models Analysis|||Baseline to Day 360||1.7|-14.9|0.111
71756030|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|3.25|<|0.001|TWO_SIDED|95.0|-18.1|-5.3|||Mixed Models Analysis|||Baseline to Day 360||-5.3|-18.1|<0.001
71756031|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-20.0|-7.8|||Mixed Models Analysis|||Baseline to Day 360||-7.8|-20.0|<0.001
71756032|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|3.3||0.013|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||400 mg LY3819469, Placebo||-1.9|-14.9|0.013
71756033|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|4.2||0.51|TWO_SIDED|95.0|-10.7|5.8|||Mixed Models Analysis|||Baseline to Day 540||5.8|-10.7|0.510
71892169|NCT04178590|143305854|SUPERIORITY|||||||0.753||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.753
71756034|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|3.35||0.173|TWO_SIDED|95.0|-11.1|2.1|||Mixed Models Analysis|||Baseline to Day 540||2.1|-11.1|0.173
71671168|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|35.3|||<|0.0001|TWO_SIDED|95.0|23.3|47.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.4|23.3|<0.0001
71671169|NCT03349060|142860125|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|42.0|65.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||65.0|42.0|<0.0001
71756035|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-18.6|-6.8|||Mixed Models Analysis|||Baseline to Day 540||-6.8|-18.6|<0.001
71756036|NCT05565742|143015085|SUPERIORITY||LS Mean difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|3.27||0.139|TWO_SIDED|95.0|-11.2|1.7|||Mixed Models Analysis|||Baseline to Day 540||1.7|-11.2|0.139
71756037|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|16.71||0.353|TWO_SIDED|95.0|-44.3|23.3|||Mixed Models Analysis|||Baseline to Day 60||23.3|-44.3|0.353
71756038|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|15.84||0.902|TWO_SIDED|95.0|-28.7|34.7|||Mixed Models Analysis|||Baseline to Day 60||34.7|-28.7|0.902
71756039|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
71756040|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|13.65||0.779|TWO_SIDED|95.0|-27.4|27.1|||Mixed Models Analysis|||Baseline to Day 60||27.1|-27.4|0.779
71756041|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|20.41||0.987|TWO_SIDED|95.0|-32.8|49.7|||Mixed Models Analysis|||Baseline to Day 180||49.7|-32.8|0.987
71756042|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|13.96||0.316|TWO_SIDED|95.0|-38.7|17.2|||Mixed Models Analysis|||Baseline to Day 180||17.2|-38.7|0.316
71837227|NCT03131648|143181221|SUPERIORITY||Risk Difference (RD)|15.2|||<|0.001|TWO_SIDED|95.0|9.2|21.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||21.3|9.2|<0.001
71837228|NCT03131648|143181222|SUPERIORITY||Risk Difference (RD)|13.0||||0.001|TWO_SIDED|95.0|5.4|20.5||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||20.5|5.4|0.001
71671170|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|0.6||||0.7285|TWO_SIDED|95.0|-3.9|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.2|-3.9|0.7285
71756043|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
71837229|NCT02671903|143181223|SUPERIORITY||Fixed Effect for Treatment|0.25||||0.3|TWO_SIDED|95.0|-0.23|0.73|||Mixed Models Analysis|||Change in treatment effect taken from mixed-model output||0.73|-0.23|0.3
71837230|NCT03779204|143181235|OTHER||Mean Difference (Final Values)|-2.0||||0.18|TWO_SIDED|95.0|-5.0|1.0|||ANCOVA|||||1.0|-5.0|0.18
71671171|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|4.0||||0.1448|TWO_SIDED|95.0|-1.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.2|-1.2|0.1448
71756044|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|15.37||0.72|TWO_SIDED|95.0|-20.9|40.4|||Mixed Models Analysis|||Baseline to Day 180||40.4|-20.9|0.720
71756045|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|14.66||0.461|TWO_SIDED|95.0|-36.1|22.6|||Mixed Models Analysis|||Baseline to Day 240||22.6|-36.1|0.461
71756046|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|11.29||0.194|TWO_SIDED|95.0|-35.6|9.4|||Mixed Models Analysis|||Baseline to Day 240||9.4|-35.6|0.194
71756047|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|12.87||0.898|TWO_SIDED|95.0|-24.0|27.2|||Mixed Models Analysis|||Baseline to Day 240||27.2|-24.0|0.898
71756048|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|11.81||0.448|TWO_SIDED|95.0|-29.9|17.0|||Mixed Models Analysis|||Baseline to Day 240||17.0|-29.9|0.448
71756049|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|29.6|STANDARD_ERROR_OF_MEAN|28.05||0.233|TWO_SIDED|95.0|-15.4|98.4|||Mixed Models Analysis|||Baseline to Day 360||98.4|-15.4|0.233
71756050|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|18.04||0.891|TWO_SIDED|95.0|-27.6|44.9|||Mixed Models Analysis|||Baseline to Day 360||44.9|-27.6|0.891
71756051|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|17.18||0.984|TWO_SIDED|95.0|-29.0|39.9|||Mixed Models Analysis|||Baseline to Day 360||39.9|-29.0|0.984
71756052|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|19.4|STANDARD_ERROR_OF_MEAN|20.52||0.302|TWO_SIDED|95.0|-14.8|67.5|||Mixed Models Analysis|||Baseline to Day 360||67.5|-14.8|0.302
71756053|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|18.49||0.684|TWO_SIDED|95.0|-37.9|36.8|||Mixed Models Analysis|||Baseline to Day 540||36.8|-37.9|0.684
71756054|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|16.19||0.933|TWO_SIDED|95.0|-28.6|36.3|||Mixed Models Analysis|||Baseline to Day 540||36.3|-28.6|0.933
71756055|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|16.33||0.962|TWO_SIDED|95.0|-26.7|38.6|||Mixed Models Analysis|||Baseline to Day 540||38.6|-26.7|0.962
71756056|NCT05565742|143015086|SUPERIORITY||LS Mean difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|18.52||0.422|TWO_SIDED|95.0|-17.2|56.9|||Mixed Models Analysis|||Baseline to Day 540||56.9|-17.2|0.422
71756057|NCT02855125|143015088|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2744|TWO_SIDED|95.0|0.71|1.88|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model .|||1.88|0.71|0.2744
71756058|NCT02855125|143015089|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.1431|TWO_SIDED|95.0|0.8|2.14|||Log Rank|1-sided stratified log-rank test.|Based on stratified Cox regression model.|||2.14|0.80|0.1431
71756059|NCT04467905|143015094|SUPERIORITY||Mean Difference (Final Values)|-29.9|||<|0.0001|TWO_SIDED|95.0|-40.3|-19.3|||ANCOVA||The mean difference is the difference in adjusted means for the change between baseline value and nadir in the placebo group and the change between baseline and nadir in the etripamil group.|||-19.3|-40.3|<0.0001
71756060|NCT05523089|143015099|SUPERIORITY||Hodges-Lehmann estimator|-1.2||||0.039|TWO_SIDED|95.0|-5.7|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-5.7|0.0390
71756061|NCT05523089|143015101|SUPERIORITY||Mean Difference (Net)|-1.4||||0.0185|TWO_SIDED|95.0|-2.9|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.0|-2.9|0.0185
71671172|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|3.9||||0.2576|TWO_SIDED|95.0|-2.6|10.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||10.5|-2.6|0.2576
71671173|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|20.4||||0.0001|TWO_SIDED|95.0|12.0|28.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.9|12.0|0.0001
71756062|NCT05523089|143015103|SUPERIORITY|||||||0.0613||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.0613
71756063|NCT05523089|143015104|SUPERIORITY||Hodges-Lehmann estimator|0.0||||0.1587|TWO_SIDED|95.0|-2.4|0.0||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.0|-2.4|0.1587
71756064|NCT05523089|143015106|SUPERIORITY||Mean Difference (Net)|-1.1||||0.0236|TWO_SIDED|95.0|-2.0|-0.1||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||-0.1|-2.0|0.0236
71756065|NCT05523089|143015108|SUPERIORITY|||||||0.1282||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.1282
71756066|NCT05523089|143015109|SUPERIORITY||Mean Difference (Net)|-5.4||||0.2877|TWO_SIDED|95.0|-11.2|0.3||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.3|-11.2|0.2877
71671174|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|9.0||||0.0423|TWO_SIDED|95.0|1.3|16.8|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.8|1.3|0.0423
71756067|NCT05523089|143015111|SUPERIORITY||Mean Difference (Net)|-1.8||||0.2517|TWO_SIDED|95.0|-4.1|0.6||alpha = 0.025 one-sided|Wilcoxon (Mann-Whitney)|||||0.6|-4.1|0.2517
71756068|NCT05523089|143015115|SUPERIORITY|||||||0.9024||||||alpha = 0.025 one-sided|Gehan-Wilcoxon|||||||0.9024
71756069|NCT05523089|143015116|SUPERIORITY|||||||0.0248||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.0248
71756070|NCT05523089|143015118|SUPERIORITY|||||||0.1224||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1224
71756071|NCT05523089|143015120|SUPERIORITY|||||||0.1023||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1023
71756072|NCT05523089|143015122|SUPERIORITY|||||||0.1477||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1477
71756073|NCT05523089|143015124|SUPERIORITY|||||||0.1645||||||alpha = 0.025 one-sided|Fisher Exact|||||||0.1645
71756074|NCT00744497|143015180|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9009|TWO_SIDED|95.53|0.87|1.13||An interim analysis on survival was performed and the final test was corrected for multiplicity.|Log Rank|||Confidence intervals for median overall survival calculated using Brookmeyer and Crowley method. Compared survival in arms by 2-sided, alpha=0.0447 level, log-rank test, stratified by bisphosphonate intake (yes/no) and urinary N-telopeptide category (\<60 vs ≥60 nmol/mmol creatinine) defined at randomization. Null hypothesis was survival equal in both arms. Power calculations were that ≥858 deaths would lead to ≥90% power at 5% level for rejecting null hypothesis, given true hazard ratio of 0.8.||1.13|0.87|0.9009
71756075|NCT00744497|143015181|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.935|||||TWO_SIDED|95.0|0.688|1.271||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.271|0.688|
71756076|NCT00744497|143015182|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.02|0.64|
71756077|NCT00744497|143015183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.93|1.763||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.||1.763|0.930|
71756078|NCT00744497|143015184|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.82|1.05||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.05|0.82|
71756079|NCT00744497|143015185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.79|1.01||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.||1.01|0.79|
71756080|NCT00744497|143015186|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791|||||TWO_SIDED|95.0|0.594|1.052||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for of experimental to control group.||1.052|0.594|
71756081|NCT01116986|143015204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.954||||0.312|TWO_SIDED|95.0|0.871|1.045|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.045|.871|.312
71756082|NCT01116986|143015204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.664|TWO_SIDED|95.0|0.894|1.074|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.074|.894|.664
71756083|NCT01116986|143015204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.989||||0.814|TWO_SIDED|95.0|0.903|1.084|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.084|.903|.814
71756084|NCT01116986|143015204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.925||||0.093|TWO_SIDED|95.0|0.844|1.013|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.013|.844|.093
71756085|NCT01116986|143015204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983||||0.716|TWO_SIDED|95.0|0.898|1.077|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.077|.898|.716
71756086|NCT01116986|143015204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.031||||0.511|TWO_SIDED|95.0|0.941|1.13|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).||1.130|.941|.511
71756087|NCT01116986|143015205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.087||||0.341|TWO_SIDED|95.0|0.916|1.29|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.||1.290|.916|.341
71756088|NCT01116986|143015205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.207|TWO_SIDED|95.0|0.941|1.325|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.325|.941|.207
71756089|NCT01116986|143015205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.196||||0.041|TWO_SIDED|95.0|1.008|1.42|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.420|1.008|.041
71788173|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.0|0.78||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.78|-0.00|
71756090|NCT01116986|143015205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.056||||0.536|TWO_SIDED|95.0|0.889|1.254|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.254|.889|.536
71756091|NCT01116986|143015205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.587|TWO_SIDED|95.0|0.883|1.246|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.||1.246|.883|.587
71788174|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.29|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.29|
71813248|NCT01392300|143129006|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.002|TWO_SIDED|95.0|1.4|4.46|||Regression, Logistic|||||4.46|1.40|0.002
71892170|NCT04178590|143305855|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71756092|NCT01116986|143015205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.389|TWO_SIDED|95.0|0.909|1.278|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.||1.278|.909|.389
71756093|NCT03819114|143015207|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.2|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.20|0.81|
71756094|NCT03819114|143015207|EQUIVALENCE|Confidence Interval on Geometric Mean Ratio compared to reference interval (0.7, 1.43).|Geometric Mean Ratio|1.34|||||TWO_SIDED|90.0|1.12|1.6|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.60|1.12|
71756095|NCT03819114|143015207|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.27|2.18|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.18|1.27|
71756096|NCT03819114|143015207|SUPERIORITY|Confidence Interval on Geometric Mean Ratio excluding 1.|Geometric Mean Ratio|0.59|||||TWO_SIDED|90.0|0.45|0.78|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.45|
71756097|NCT03819114|143015208|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p\<0.05.|Fisher Exact|||||||1.00
71756098|NCT03819114|143015209|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.96|1.41|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.41|0.96|
71756099|NCT03819114|143015209|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.43|||||TWO_SIDED|90.0|1.21|1.69|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.69|1.21|
71756100|NCT03819114|143015209|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.17|1.96|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.96|1.17|
71756101|NCT03819114|143015209|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.6|1.0|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.00|0.60|
71756102|NCT03819114|143015210|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.37|||||TWO_SIDED|90.0|0.22|0.61|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.61|0.22|
71756103|NCT03819114|143015210|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.25|||||TWO_SIDED|90.0|0.15|0.44|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.44|0.15|
71756104|NCT03819114|143015210|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.11|||||TWO_SIDED|90.0|1.2|3.7|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.70|1.20|
71756105|NCT03819114|143015210|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.17|||||TWO_SIDED|90.0|0.09|0.32|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.32|0.09|
71756106|NCT03819114|143015211|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|4.03|||||TWO_SIDED|90.0|3.17|5.12|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||5.12|3.17|
71756107|NCT03819114|143015211|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.92|||||TWO_SIDED|90.0|2.33|3.65|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||3.65|2.33|
71756108|NCT03819114|143015211|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.82|1.52|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.52|0.82|
71756109|NCT03819114|143015211|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|3.62|||||TWO_SIDED|90.0|2.65|4.93|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||4.93|2.65|
71788175|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|0.59|1.45||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.45|0.59|
71788176|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.21|0.62||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.21|
71813249|NCT01392300|143129007|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.102|TWO_SIDED|95.0|0.9|3.22|||Regression, Logistic|||||3.22|0.90|0.102
71813250|NCT01392300|143129008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.67|5.23|||Regression, Logistic|||||5.23|1.67|<0.001
71756110|NCT03819114|143015212|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|2.1|||||TWO_SIDED|90.0|1.66|2.65|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.65|1.66|
71756111|NCT03819114|143015212|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.39|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.39|0.89|
71756112|NCT03819114|143015212|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.2|||||TWO_SIDED|90.0|0.87|1.66|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.66|0.87|
71756113|NCT03819114|143015212|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.24|2.45|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.24|
71756114|NCT03819114|143015213|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.52|||||TWO_SIDED|90.0|0.46|0.59|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.59|0.46|
71756115|NCT03819114|143015213|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.38|||||TWO_SIDED|90.0|0.34|0.43|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.43|0.34|
71756116|NCT03819114|143015213|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.25|0.93|
71756117|NCT03819114|143015213|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.48|||||TWO_SIDED|90.0|0.41|0.56|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.56|0.41|
71756118|NCT03819114|143015215|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.75|||||TWO_SIDED|90.0|0.6|0.93|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.93|0.60|
71788177|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.07|0.76||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|-0.07|
71788178|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-0.11|0.72||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.11|
71788179|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|0.85|1.75||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.75|0.85|
71756119|NCT03819114|143015215|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.9|1.36|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.36|0.90|
71756120|NCT03819114|143015215|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.74|||||TWO_SIDED|90.0|1.29|2.33|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.33|1.29|
71756121|NCT03819114|143015215|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.43|||||TWO_SIDED|90.0|0.32|0.58|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.58|0.32|
71756122|NCT03819114|143015216|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.62|||||TWO_SIDED|90.0|0.49|0.78|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.78|0.49|
71756123|NCT03819114|143015216|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.71|1.1|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||1.10|0.71|
71756124|NCT03819114|143015216|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.77|||||TWO_SIDED|90.0|1.31|2.4|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.40|1.31|
71756125|NCT03819114|143015216|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.35|||||TWO_SIDED|90.0|0.26|0.47|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.47|0.26|
71813251|NCT01392300|143129009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.002|TWO_SIDED|95.0|1.37|4.41|||Regression, Logistic|||||4.41|1.37|0.002
71813252|NCT01392300|143129010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.069|TWO_SIDED|95.0|0.95|3.69|||Regression, Logistic|||||3.69|0.95|0.069
71813253|NCT01392300|143129011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.034|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.034
71813254|NCT01392300|143129012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.169|TWO_SIDED|95.0|0.82|3.16|||Regression, Logistic|||||3.16|0.82|0.169
71813255|NCT01392300|143129013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.49|2.18|||Regression, Logistic|||||2.18|0.49|0.920
71756126|NCT03819114|143015217|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.5|||||TWO_SIDED|90.0|0.39|0.63|||||The ratios of the geometric means (group B / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.63|0.39|
71756127|NCT03819114|143015217|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.69|||||TWO_SIDED|90.0|0.55|0.86|||||The ratios of the geometric means (group D / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.86|0.55|
71756128|NCT03819114|143015217|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|1.8|||||TWO_SIDED|90.0|1.32|2.45|||||The ratios of the geometric means (group B / group A) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||2.45|1.32|
71756129|NCT03819114|143015217|OTHER|No hypothesis testing was performed.|Geometric Mean Ratio|0.28|||||TWO_SIDED|90.0|0.2|0.38|||||The ratios of the geometric means (group A / group C) and its 90% CI were obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|||0.38|0.20|
71756130|NCT02492763|143015218|SUPERIORITY||Difference in Least Squares Means|-0.39||||0.126|TWO_SIDED|95.0|-0.88|0.11|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.11|-0.88|0.126
71756131|NCT02492763|143015218|SUPERIORITY||Difference in Least Squares Means|0.6||||0.017|TWO_SIDED|95.0|0.11|1.08|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.08|0.11|0.017
71756132|NCT02492763|143015218|SUPERIORITY||Difference in Least Squares Means|-0.61||||0.018|TWO_SIDED|95.0|-1.12|-0.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.10|-1.12|0.018
71756133|NCT02492763|143015218|SUPERIORITY||Difference in Least Squares Means|0.37||||0.146|TWO_SIDED|95.0|-0.13|0.87|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.87|-0.13|0.146
71756134|NCT02492763|143015218|SUPERIORITY||Difference in the Least Squares Means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.49|-0.48||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.48|-1.49|<0.001
71788180|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.04|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.04|
71788181|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.1|0.75||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.75|-0.10|
71756135|NCT02492763|143015221|SUPERIORITY||Difference in % vs Placebo|-2.3||||0.301|TWO_SIDED|95.0|-12.1|5.6|||Miettinen & Nurminen method|||||5.6|-12.1|0.301
71756136|NCT02492763|143015221|SUPERIORITY||Difference in % vs Placebo|2.2||||0.573|TWO_SIDED|95.0|-8.1|13.2|||Miettinen & Nurminen method|||||13.2|-8.1|0.573
71756137|NCT02492763|143015221|SUPERIORITY||Difference in % vs Liraglutide|-2.4||||0.295|TWO_SIDED|95.0|-12.4|5.5|||Miettinen & Nurminen method|||||5.5|-12.4|0.295
71756138|NCT02492763|143015221|SUPERIORITY||Difference in % vs Liraglutide|2.2||||0.587|TWO_SIDED|95.0|-8.4|13.2|||Miettinen & Nurminen method|||||13.2|-8.4|0.587
71756139|NCT02492763|143015222|SUPERIORITY||Difference in the LS Means vs. Placebo|6.9|||||TWO_SIDED|95.0|3.42|10.37|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|10.37|3.42|
71756140|NCT02492763|143015222|SUPERIORITY||Difference in LS Means vs. Liraglutide|3.84|||||TWO_SIDED|95.0|0.35|7.33|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|7.33|0.35|
71756141|NCT02492763|143015222|SUPERIORITY||Difference in LS Means vs. Placebo|7.7|||||TWO_SIDED|95.0|4.17|11.23|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|11.23|4.17|
71756142|NCT02492763|143015222|SUPERIORITY||Difference in LS Means vs. Liraglutide|4.65|||||TWO_SIDED|95.0|1.11|8.19|||||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis|8.19|1.11|
71813256|NCT01392300|143129014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.83|6.91|||Regression, Logistic|||||6.91|1.83|<0.001
71813257|NCT01392300|143129015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.007|TWO_SIDED|95.0|1.28|4.56|||Regression, Logistic|||||4.56|1.28|0.007
71813258|NCT01392300|143129016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26||||0.018|TWO_SIDED|95.0|1.15|4.41|||Regression, Logistic|||||4.41|1.15|0.018
71813259|NCT01392300|143129017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
71813260|NCT01392300|143129018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.011|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.011
71813261|NCT01392300|143129019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.032
71813262|NCT01392300|143129020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|<0.001
71813263|NCT01392300|143129021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|<0.001
71813264|NCT01392300|143129022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.029|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.029
71756143|NCT02492763|143015223|SUPERIORITY||Difference in Least Squares Means|-0.7||||0.285|TWO_SIDED|95.0|-2.0|0.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||0.6|-2.0|0.285
71756144|NCT02492763|143015223|SUPERIORITY||Difference in Least Squares Means|0.9||||0.183|TWO_SIDED|95.0|-0.4|2.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.2|-0.4|0.183
71756145|NCT02492763|143015223|SUPERIORITY||Difference in Least Squares Means|-1.8||||0.01|TWO_SIDED|95.0|-3.1|-0.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-0.4|-3.1|0.010
71756146|NCT02492763|143015223|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.2|-1.5|0.811
71756147|NCT02492763|143015223|SUPERIORITY||Difference in the Least Squares Means|-1.6||||0.018|TWO_SIDED|95.0|-2.9|-0.3||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-0.3|-2.9|0.018
71756148|NCT02492763|143015224|SUPERIORITY||Difference in Least Squares Means|-8.6||||0.385|TWO_SIDED|95.0|-28.2|10.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||10.9|-28.2|0.385
71756149|NCT02492763|143015224|SUPERIORITY||Difference in Least Squares Means|29.1||||0.004|TWO_SIDED|95.0|9.7|48.6|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||48.6|9.7|0.004
71756150|NCT02492763|143015224|SUPERIORITY||Difference in Least Squares Means|-29.5||||0.004|TWO_SIDED|95.0|-49.6|-9.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||-9.4|-49.6|0.004
71756151|NCT02492763|143015224|SUPERIORITY||Difference in Least Squares Means|8.3||||0.416|TWO_SIDED|95.0|-11.7|28.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||28.2|-11.7|0.416
71756152|NCT02492763|143015224|SUPERIORITY||Difference in the Least Squares Means|-37.8|||<|0.001|TWO_SIDED|95.0|-57.5|-18.0||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||-18.0|-57.5|<0.001
71756153|NCT02492763|143015228|SUPERIORITY||Difference in Least Squares Means|-3.7||||0.151|TWO_SIDED|95.0|-8.8|1.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||1.4|-8.8|0.151
71756154|NCT02492763|143015228|SUPERIORITY||Difference in Least Squares Means|-1.1||||0.682|TWO_SIDED|95.0|-6.2|4.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.1|-6.2|0.682
71756155|NCT02492763|143015228|SUPERIORITY||Difference in Least Squares Means|-2.5||||0.344|TWO_SIDED|95.0|-7.7|2.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||2.7|-7.7|0.344
71756156|NCT02492763|143015228|SUPERIORITY||Difference in Least Squares Means|0.2||||0.948|TWO_SIDED|95.0|-5.0|5.4|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||5.4|-5.0|0.948
71756157|NCT02492763|143015228|SUPERIORITY||Difference in the Least Squares Means|-2.7||||0.306|TWO_SIDED|95.0|-7.8|2.5||Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis|||||2.5|-7.8|0.306
71756158|NCT02492763|143015229|SUPERIORITY||Difference in Least Squares Means|1.5||||0.347|TWO_SIDED|95.0|-1.7|4.8|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.8|-1.7|0.347
71756159|NCT02492763|143015229|SUPERIORITY||Difference in Least Squares Means|-0.1||||0.963|TWO_SIDED|95.0|-3.3|3.2|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.2|-3.3|0.963
71756160|NCT02492763|143015229|SUPERIORITY||Difference in Least Squares Means|1.4||||0.394|TWO_SIDED|95.0|-1.9|4.7|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.7|-1.9|0.394
71756161|NCT02492763|143015229|SUPERIORITY||Difference in Least Squares Means|-0.2||||0.905|TWO_SIDED|95.0|-3.5|3.1|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||3.1|-3.5|0.905
71756162|NCT02492763|143015229|SUPERIORITY||Difference in the Least Squares Means|1.6||||0.325|TWO_SIDED|95.0|-1.6|4.9|||Longitudinal data analysis|Terms for treatment, time, A1C (\<8.5%, ≥8.5%), BMI (\<30 kg/m\^2, ≥30 kg/m\^2) and AHA washout status (Yes, No), and the interaction of time by treatment||||4.9|-1.6|0.325
71756163|NCT01337960|143015230|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Fisher Exact|||||||< 0.01
71756164|NCT01337960|143015231|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||Fisher Exact|||||||<.02
71756165|NCT01337960|143015232|SUPERIORITY_OR_OTHER||||||=|0.17|TWO_SIDED||||||Fisher Exact|||||||=0.17
71837231|NCT03779204|143181236|OTHER||Mean Difference (Final Values)|-1.4||||0.44|TWO_SIDED|95.0|-5.0|2.3|||ANCOVA|||||2.3|-5.0|0.44
71837232|NCT03779204|143181237|OTHER||Mean Difference (Final Values)|7.3||||0.38|TWO_SIDED|95.0|-9.7|24.4|||ANCOVA|||||24.4|-9.7|.38
71837233|NCT03779204|143181238|OTHER||Mean Difference (Final Values)|0.6||||0.76|TWO_SIDED|95.0|-3.3|4.4|||ANCOVA|||||4.4|-3.3|0.76
71837234|NCT03779204|143181239|OTHER|||||||0.68|||||||ANCOVA|||||||0.68
71671175|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|28.0|||<|0.0001|TWO_SIDED|95.0|18.7|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|18.7|<0.0001
71671176|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|13.3||||0.0066|TWO_SIDED|95.0|5.4|21.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||21.2|5.4|0.0066
71671177|NCT03349060|142860126|SUPERIORITY||Difference in Percentage|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.5|24.3|<0.0001
71671178|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71671179|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.8|3.8||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.8|-3.8|
71671180|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-3.9|3.9||P-value could not be calculated since percentage of participants with events was 0.||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||3.9|-3.9|
71671181|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|6.5||||0.0234|TWO_SIDED|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|1.3|0.0234
71671182|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|4.6||||0.0604|TWO_SIDED|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.5|-0.3|0.0604
71837235|NCT03779204|143181240|OTHER||Mean Difference (Final Values)|-7.2||||0.12|TWO_SIDED|95.0|-16.4|2.0|||ANCOVA|||||2.0|-16.4|0.12
71671183|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|11.7||||0.0022|TWO_SIDED|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|5.5|0.0022
71671184|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|6.4||||0.0255|TWO_SIDED|95.0|1.2|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.6|1.2|0.0255
71756166|NCT01337960|143015233|SUPERIORITY_OR_OTHER||||||=|0.35|TWO_SIDED||||||Fisher Exact|||||||=0.35
71892171|NCT04178590|143305856|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71671185|NCT03349060|142860127|SUPERIORITY||Difference in Percentage|13.1||||0.001|TWO_SIDED|95.0|6.7|19.4|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.4|6.7|0.0010
71671186|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-5.8|||<|0.0001|TWO_SIDED|95.0|-8.2|-3.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-8.2|<0.0001
71671187|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.0|-8.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.1|-13.0|<0.0001
71756167|NCT02584686|143015393|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the study group using the t-test.||||0.0049
71837236|NCT03779204|143181241|OTHER||Mean Difference (Final Values)|-4.4||||0.34|TWO_SIDED|95.0|-13.7|5.0|||ANCOVA|||||5.0|-13.7|0.34
71837237|NCT03779204|143181243|OTHER||Mean Difference (Final Values)|-1.3||||0.62|TWO_SIDED|95.0|-6.6|4.0|||ANCOVA|||||4.0|-6.6|0.62
71837238|NCT04258709|143181246|SUPERIORITY|||||||0.12|||||||Chi-squared|||||||.1200
71837239|NCT04258709|143181246|SUPERIORITY||Odds Ratio (OR)|0.593||||0.0474|TWO_SIDED|95.0|0.352|0.9907|||Regression, Logistic||Adjusted for race, Iowa Infant Feeding Attitudes Score at baseline, infant gestational age, NICU admission, maternal age at enrollment, WIC enrollment at baseline, maternal pre-pregnancy BMI. This is an adjusted odds ratio.|||.9907|.352|.0474
71892172|NCT04178590|143305857|SUPERIORITY|||||||0||||||p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.000
71892173|NCT00310310|143305890|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
71892174|NCT00310310|143305891|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 1 sided|||||||0.023
71892175|NCT00310310|143305892|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 1 sided|||||||0.8
71892176|NCT00310310|143305894|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 1 sided|||||||0.96
71892177|NCT00310310|143305895|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 1 sided|||||||0.59
71756168|NCT02584686|143015393|SUPERIORITY_OR_OTHER|||||||0.68|||||||t-test, 1 sided|||Comparing the mean PSV before \& after treatment in the control group using the t-test.||||0.68
71756169|NCT02584686|143015395|SUPERIORITY_OR_OTHER|||||||0.01086956|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the study group.||||0.01086956
71756170|NCT02584686|143015395|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before \& after treatment in the control group.||||0.6618176
71756171|NCT02584686|143015397|SUPERIORITY_OR_OTHER|||||||0.00751288|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the study group before \& after treatment.||||0.00751288
71756172|NCT02584686|143015397|SUPERIORITY_OR_OTHER|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the control group before \& after treatment.||||0.6618176
71756173|NCT02584686|143015398|SUPERIORITY_OR_OTHER|||||||0.027191||||||"Due to the small sample size Fisher exact test was chosen. 7 out of 12 in the treatment group answered yes, while 1 out of 12 in the control group answered yes."|Fisher Exact|||||||0.027191
71756174|NCT02584686|143015400|SUPERIORITY_OR_OTHER|||||||0.109091|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in the number of in patients who answered Yes in Secondary Outcome 8 (SEP-Q2 Question Before Treatment) to patients who answered Yes in Secondary Outcome 9 (SEP-Q2 Question after Treatment), for both (BTXA) and Saline groups."||||0.109091
71756175|NCT02584686|143015402|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in patients who answered Yes in Secondary Outcome 10 (SEP-Q3 Question Before Treatment) to patients who answered Yes in Secondary Outcome 11 (SEP-Q3 Question after Treatment)."||||1
71756176|NCT01709721|143015403|SUPERIORITY|||||||0.147|||||||Chi-squared|Pearson's chi-square test||Superiority of intrathecal hydromorphone hydrochloride as compared to a control arm.||||0.147
71756177|NCT01709721|143015404|SUPERIORITY|||||||0.0342|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0342
71756178|NCT01709721|143015405|SUPERIORITY|||||||0.1642|||||||ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.1642
71756179|NCT01709721|143015406|SUPERIORITY|||||||0.016|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0160
71756180|NCT01709721|143015407|SUPERIORITY|||||||0.0007|||||||ANCOVA|ANCOVA, with randomization group as the factor and initial parameter value as covariate.||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0007
71756181|NCT01709721|143015408|SUPERIORITY|||||||0.0088||||||ANCOVA, with randomization group as the factor and initial parameter value as covariate.|ANCOVA|||"P-value by ANCOVA, with randomization group as the factor and initial parameter value as covariate.~Note: For subjects with missing endpoint on Day 119, value is imputed using the Last Observation Carried Forward (LOCF).~Note: Baseline for this analysis is the Day 84 visit."||||0.0088
71756182|NCT01709721|143015409|SUPERIORITY|||||||0.011||||||Log-rank test for Kaplan-Meier Estimate of Time to Rescue (days).|Log Rank|||||||0.011
71756183|NCT01709721|143015410|SUPERIORITY|||||||0.0335|||||||Cochran-Mantel-Haenszel|||P-value by the Cochran-Mantel-Haenszel mean score test (using equally spaced scores).||||0.0335
71756184|NCT01709721|143015412|SUPERIORITY|Pearson's chi-square test||||||0.01||||||Pearson's chi-square test|Chi-squared|||||||0.010
71671188|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-7.9|||<|0.0001|TWO_SIDED|95.0|-10.7|-5.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.0|-10.7|<0.0001
71756185|NCT00106704|143015440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-90.0|-0.57|||ANCOVA|Model terms: treatment, stratum (on metformin or not), baseline A1C||||-0.57|-90.0|<0.001
71756186|NCT00106704|143015441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.1|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-28.4|-11.8|||ANCOVA|Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C||||-11.8|-28.4|<0.001
71756187|NCT00001959|143015466|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||H0: GFR Decrease during baseline period and treatment period are same||||<0.01
71756188|NCT00001959|143015467|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Kruskal-Wallis|||H0: Proteinuria during baseline and treatment periods are same||||0.16
71756189|NCT04825678|143015580|OTHER||Least squares mean (LSM)|40.72|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|36.05|45.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline monthly migraine days (MMD), and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||45.39|36.05|< 0.001
71756190|NCT04825678|143015580|OTHER||LSM|30.84|STANDARD_ERROR_OF_MEAN|14.53||0.058|TWO_SIDED|95.0|-1.3|62.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||62.98|-1.30|0.058
71756191|NCT04825678|143015581|OTHER||LSM|37.87|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|28.62|47.12||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||47.12|28.62|< 0.001
71671189|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-12.7|||<|0.0001|TWO_SIDED|95.0|-15.6|-9.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.9|-15.6|<0.0001
71671190|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.5|-11.6|<0.0001
71671191|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-13.5|||<|0.0001|TWO_SIDED|95.0|-16.5|-10.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.4|-16.5|<0.0001
71671192|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.6|-5.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.1|-11.6|<0.0001
71671193|NCT03349060|142860128|SUPERIORITY||Difference in LS mean|-14.0|||<|0.0001|TWO_SIDED|95.0|-17.3|-10.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.8|-17.3|<0.0001
71671194|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-7.8||||0.0004|TWO_SIDED|95.0|-12.1|-3.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.5|-12.1|0.0004
71671195|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-14.8|||<|0.0001|TWO_SIDED|95.0|-19.0|-10.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-10.5|-19.0|<0.0001
71671196|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.6|-6.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.9|-16.6|<0.0001
71756192|NCT04825678|143015581|OTHER||LSM|43.25|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|38.06|48.44||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes Baseline TSQM overall satisfaction scale score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.||48.44|38.06|< 0.001
71756193|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.9|STANDARD_ERROR_OF_MEAN|2.28|<|0.001|TWO_SIDED|95.0|-49.39|-40.41||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Physical Function Domain||-40.41|-49.39|< 0.001
71756194|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-54.15|STANDARD_ERROR_OF_MEAN|8.43|<|0.001|TWO_SIDED|95.0|-73.43|-34.86||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Physical Function Domain||-34.86|-73.43|< 0.001
71813265|NCT01392300|143129023|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
71671197|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-18.5|||<|0.0001|TWO_SIDED|95.0|-23.4|-13.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-13.6|-23.4|<0.0001
71671198|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.7|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.7|<0.0001
71671199|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-22.6|||<|0.0001|TWO_SIDED|95.0|-28.0|-17.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-28.0|<0.0001
71671200|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.3|-8.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-8.2|-19.3|<0.0001
71671201|NCT03349060|142860129|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.6|-16.5|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.5|-27.6|<0.0001
71671202|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|1.3||||0.521|TWO_SIDED|95.0|-3.4|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.0|-3.4|0.5210
71671203|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|4.0||||0.1416|TWO_SIDED|95.0|-1.3|9.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.3|-1.3|0.1416
71671204|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|4.6||||0.2002|TWO_SIDED|95.0|-2.1|11.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.2|-2.1|0.2002
71671205|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|23.6|||<|0.0001|TWO_SIDED|95.0|15.1|32.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.2|15.1|<0.0001
71671206|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|9.6||||0.0434|TWO_SIDED|95.0|1.3|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.9|1.3|0.0434
71837240|NCT04258709|143181247|SUPERIORITY|||||||0.5201|||||||t-test, 1 sided|||||||.5201
71837241|NCT04258709|143181247|SUPERIORITY||Slope|0.1399||||0.9178|TWO_SIDED|95.0|-2.5299|2.8098|||Regression, Linear|||||2.8098|-2.5299|.9178
71837242|NCT04258709|143181248|SUPERIORITY|||||||0.8614|||||||t-test, 1 sided|||||||.8614
71837243|NCT04258709|143181248|SUPERIORITY||Odds Ratio (OR)|1.0763||||0.7836|TWO_SIDED|95.0|0.6364|1.8216|||Regression, Logistic|||||1.8216|.6364|.7836
71671207|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|26.6|||<|0.0001|TWO_SIDED|95.0|17.1|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.2|17.1|<0.0001
71671208|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|15.8||||0.0019|TWO_SIDED|95.0|7.5|24.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||24.0|7.5|0.0019
71756195|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.35|STANDARD_ERROR_OF_MEAN|1.99|<|0.001|TWO_SIDED|95.0|-48.26|-40.44||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Usual Activities Domain||-40.44|-48.26|< 0.001
71813266|NCT01392300|143129024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.019|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.019
71671209|NCT03349060|142860130|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|24.0|42.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||42.7|24.0|<0.0001
71671210|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|10.8||||0.0151|TWO_SIDED|95.0|3.3|18.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.3|3.3|0.0151
71813267|NCT01392300|143129025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.137|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.137
71813268|NCT01392300|143129026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.013|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.013
71813269|NCT01392300|143129027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.131|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.131
71813270|NCT01392300|143129028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.714|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.714
71813271|NCT01392300|143129029|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||||-0.2|-0.5|<0.001
71813272|NCT01392300|143129030|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.008
71813273|NCT01392300|143129031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.062|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.062
71813274|NCT01392300|143129032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.006
71813275|NCT01392300|143129033|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.076|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.076
71813276|NCT01392300|143129034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.416|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.416
71837244|NCT04258709|143181249|SUPERIORITY|||||||0.9788|||||||Chi-squared|||||||.9788
71837245|NCT04258709|143181249|SUPERIORITY||Odds Ratio (OR)|1.0307||||0.9119|TWO_SIDED|95.0|0.603|1.7067|||Regression, Logistic|||||1.7067|.603|.9119
71671211|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||39.0|21.0|<0.0001
71671212|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|21.2||||0.001|TWO_SIDED|95.0|10.2|32.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.3|10.2|0.0010
71671213|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|37.9|||<|0.0001|TWO_SIDED|95.0|26.6|49.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.3|26.6|<0.0001
71788182|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.05|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.81|-0.05|
71788183|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|1.22|2.15||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.15|1.22|
71788184|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.01|0.99||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.99|0.01|
71788185|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.05|1.03||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.05|
71788186|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.04|0.94||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.04|
71788187|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.79|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.26|2.31||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.31|1.26|
71788188|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.06|1.11||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.06|
71788189|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.17||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.17|0.11|
71813277|NCT01392300|143129035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|<0.001
71813278|NCT01392300|143129036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.175|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.175
71813279|NCT01392300|143129037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.14|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.140
71813280|NCT01392300|143129038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|||||-0.1|-0.4|0.007
71813281|NCT01392300|143129039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.018|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.018
71813282|NCT01392300|143129040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.105|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.105
71813283|NCT01392300|143129041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.016
71813284|NCT01392300|143129042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.014|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|0.014
71813285|NCT01392300|143129043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.22|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.220
71813286|NCT01392300|143129044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.429|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.429
71813287|NCT01392300|143129045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.884|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.884
71813288|NCT01392300|143129046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.844|TWO_SIDED|95.0|-0.2|0.2|||ANCOVA|||||0.2|-0.2|0.844
71671214|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|23.5||||0.0003|TWO_SIDED|95.0|12.6|34.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.3|12.6|0.0003
71671215|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|41.7|||<|0.0001|TWO_SIDED|95.0|30.7|52.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||52.7|30.7|<0.0001
71671216|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|19.6||||0.0026|TWO_SIDED|95.0|8.1|31.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.1|8.1|0.0026
71671217|NCT03349060|142860131|SUPERIORITY||Difference in Percentage|40.0|||<|0.0001|TWO_SIDED|95.0|28.3|51.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||51.7|28.3|<0.0001
71671218|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|1.3||||0.3151|TWO_SIDED|95.0|-2.9|5.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.6|-2.9|0.3151
71756196|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-43.8|STANDARD_ERROR_OF_MEAN|4.47|<|0.001|TWO_SIDED|95.0|-53.51|-34.08||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Usual Activities Domain||-34.08|-53.51|< 0.001
71756197|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-44.39|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-48.65|-40.14||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Social Function Domain||-40.14|-48.65|< 0.001
71756198|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.03|STANDARD_ERROR_OF_MEAN|6.97|<|0.001|TWO_SIDED|95.0|-60.28|-29.79||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Social Function Domain||-29.79|-60.28|< 0.001
71756199|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-45.5|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-50.29|-40.7||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Continued SoC: Emotional Function Domain||-40.70|-50.29|< 0.001
71837246|NCT04258709|143181250|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.2173
71837247|NCT04258709|143181251|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.5209|TWO_SIDED|95.0|0.4192|1.216|||Regression, Logistic|||||1.216|.4192|.5209
71837248|NCT04258709|143181254|SUPERIORITY|||||||0.4258|||||||Chi-squared|||||||.4258
71837249|NCT04258709|143181254|SUPERIORITY||Odds Ratio (OR)|0.8882||||0.6246|TWO_SIDED|95.0|0.5523|1.4283|||Regression, Logistic|||||1.4283|.5523|.6246
71671219|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|6.0||||0.0292|TWO_SIDED|95.0|0.7|11.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.3|0.7|0.0292
71671220|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|-0.2||||0.9402|TWO_SIDED|95.0|-5.9|5.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.5|-5.9|0.9402
71671221|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|15.3||||0.0019|TWO_SIDED|95.0|7.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|7.3|0.0019
71837250|NCT04258709|143181255|SUPERIORITY|||||||0.5613|||||||Chi-squared|||||||.5613
71837251|NCT04258709|143181255|SUPERIORITY||Odds Ratio (OR)|0.7157||||0.2173|TWO_SIDED|95.0|0.4206|1.2178|||Regression, Logistic|||||1.2178|.4206|.2173
71671222|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|10.8||||0.0078|TWO_SIDED|95.0|4.2|17.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.4|4.2|0.0078
71837252|NCT04258709|143181256|SUPERIORITY|||||||0.6291|||||||Chi-squared|||||||.6291
71837253|NCT04258709|143181256|SUPERIORITY||Odds Ratio (OR)|1.1955||||0.5426|TWO_SIDED|95.0|0.8745|1.3931|||Regression, Logistic|||||1.3931|.8745|.5426
71837254|NCT04258709|143181257|SUPERIORITY|||||||0.9071|||||||Chi-squared|||||||.9071
71756200|NCT04825678|143015590|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-60.06|STANDARD_ERROR_OF_MEAN|10.98|<|0.001|TWO_SIDED|95.0|-85.16|-34.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||Discontinued SoC: Emotional Function Domain||-34.96|-85.16|< 0.001
71756201|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-34.38|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-41.72|-27.03||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Physical Function Domain||-27.03|-41.72|< 0.001
71756202|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-49.56|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-54.44|-44.69||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Physical Function Domain||-44.69|-54.44|< 0.001
71788190|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|0.11|1.15||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.15|0.11|
71788191|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|90.0|1.33|2.4||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.40|1.33|
71788192|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.07|1.05||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.05|-0.07|
71788193|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.24|0.91||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.24|
71788194|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.13|0.98||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.98|-0.13|
71788195|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|1.05|2.17||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||2.17|1.05|
71788196|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.74|0.64||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|-0.74|
71788197|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.86|0.56||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.56|-0.86|
71788198|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-0.57|0.8||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.57|
71788199|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|0.22|1.58||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.58|0.22|
71837255|NCT04258709|143181257|SUPERIORITY||Odds Ratio (OR)|1.0233||||0.9328|TWO_SIDED|95.0|0.7751|1.2084|||Regression, Logistic|||||1.2084|.7751|.9328
71837256|NCT04258709|143181258|SUPERIORITY||Slope|0.8213||||0.5548|TWO_SIDED|95.0|-1.9161|3.5588|||Regression, Linear|||||3.5588|-1.9161|.5548
71671223|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.2|30.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.1|14.2|<0.0001
71837257|NCT04258709|143181259|SUPERIORITY||Slope|1.2412||||0.3861|TWO_SIDED|95.0|-1.5771|4.0594|||Regression, Linear|||||4.0594|-1.5771|.3861
71837258|NCT04258709|143181260|SUPERIORITY|||||||0.4779|||||||t-test, 1 sided|||||||.4779
71837259|NCT04258709|143181261|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71837260|NCT04258709|143181261|SUPERIORITY||Odds Ratio (OR)|0.9508||||0.9163|TWO_SIDED|95.0|0.3669|2.4621|||Regression, Logistic|||||2.4621|.3669|.9163
71671224|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|8.2||||0.0528|TWO_SIDED|95.0|1.0|15.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||15.3|1.0|0.0528
71671225|NCT03349060|142860132|SUPERIORITY||Difference in Percentage|26.4|||<|0.0001|TWO_SIDED|95.0|17.6|35.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.3|17.6|<0.0001
71671226|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.9|<0.0001
71756203|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed baseline MMD, and selected baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-35.76|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-41.47|-30.06||P-value is nominal to compare the mean change from baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Usual Activities Domain||-30.06|-41.47|< 0.001
71756204|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.7|STANDARD_ERROR_OF_MEAN|2.23|<|0.001|TWO_SIDED|95.0|-51.1|-42.29||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Usual Activities Domain||-42.29|-51.10|< 0.001
71788200|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.93|0.59||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.59|-0.93|
71788201|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.98|0.62||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.98|
71788202|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.05|0.45||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-1.05|
71788203|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-0.47|1.02||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.02|-0.47|
71788204|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|0.15|1.11||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.11|0.15|
71788205|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.74||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.74|-0.27|
71788206|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-0.03|0.91||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.91|-0.03|
71788207|NCT01529346|143074318|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.3|0.67||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.67|-0.30|
71788208|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.19|0.14||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.14|-0.19|
71788209|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.03|0.37||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.37|0.03|
71837261|NCT04258709|143181262|SUPERIORITY||Odds Ratio (OR)|1.1084||||0.8031|TWO_SIDED|95.0|0.4937|2.4882|||Regression, Logistic|||||2.4882|.4937|.8031
71671227|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-3.0|<0.0001
71892178|NCT00310310|143305896|SUPERIORITY_OR_OTHER|||||||0|||||||t-test, 1 sided|||||||0.00
71756205|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-36.42|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-42.89|-29.96||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Social Function Domain||-29.96|-42.89|< 0.001
71756206|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-46.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-51.49|-41.98||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Social Function Domain||-41.98|-51.49|< 0.001
71756207|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-41.44|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-49.47|-33.4||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||EM: Emotional Function Domain||-33.40|-49.47|< 0.001
71756208|NCT04825678|143015591|OTHER|Adjusted analysis utilizes a generalized linear mixed model which includes Baseline function domain score, visit, the prevailing erenumab dose from Week 12 onwards, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure.|LSM|-47.67|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-52.95|-42.39||P-value is nominal to compare the mean change from Baseline at Week 24 to zero.|Mixed Models Analysis|||CM: Emotional Function Domain||-42.39|-52.95|< 0.001
71788210|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-0.1|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.24|-0.10|
71788211|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.16|0.21||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.21|-0.16|
71788212|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|-0.06|0.45||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.06|
71788213|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.19|0.7||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.70|0.19|
71788214|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|90.0|0.04|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.54|0.04|
71788215|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.32|0.87||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.87|0.32|
71788216|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.16|0.4||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.16|
71788217|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.12|0.68||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|0.12|
71788218|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.05|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.50|-0.05|
71837262|NCT04258709|143181263|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8175|TWO_SIDED|95.0|0.3882|3.3161|||Regression, Logistic|||||3.3161|.3882|.8175
71837263|NCT04258709|143181264|SUPERIORITY||Odds Ratio (OR)|0.6964||||0.434|TWO_SIDED|95.0|0.2813|1.7241|||Regression, Logistic|||||1.7241|.2813|.434
71837264|NCT04258709|143181265|SUPERIORITY||Odds Ratio (OR)|1.2533||||0.4968|TWO_SIDED|95.0|0.6534|2.4041|||Regression, Logistic|||||2.4041|.6534|.4968
71837265|NCT04258709|143181266|SUPERIORITY||Odds Ratio (OR)|1.0288||||0.9005|TWO_SIDED|95.0|0.659|1.6062|||Regression, Logistic|||||1.6062|.659|.9005
71837266|NCT04258709|143181267|SUPERIORITY||Slope|-1.4018||||0.127|TWO_SIDED|95.0|-3.2052|0.4015|||Regression, Linear|||||.4015|-3.2052|.127
71837267|NCT04258709|143181268|SUPERIORITY||Slope|-1.8958||||0.07|TWO_SIDED|95.0|-3.9475|0.1559|||Regression, Linear|||||.1559|-3.9475|.07
71837268|NCT04258709|143181269|SUPERIORITY||Slope|-0.506||||0.6299|TWO_SIDED|95.0|-2.574|1.562|||Regression, Linear|||||1.562|-2.574|.6299
71892179|NCT00310310|143305897|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
71671228|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.2|<0.0001
71671229|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-3.4|<0.0001
71671230|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-2.3|<0.0001
71671231|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.8|-3.2|<0.0001
71756209|NCT02086175|143015592|SUPERIORITY||percent|48.0||||0.044|TWO_SIDED|90.0|31.0|66.0|||Fisher Exact|||"Patients will be accrued in a single stage design, with a goal accrual of 25 patients.~Assuming a 30% response rate with rituximab alone, if the true but unknown rate of CR or PR is 50% with the addition of Imprime PGG, the probability of observing 11 or more patients with a response is 0.79 with 0.098 one-sided type-I error.~Therefore a study with 25 patients, in which an observed response rate of 11/25 (44%) would be considered worthy of further consideration."||66|31|0.044
71756210|NCT00664443|143015644|OTHER||Sensitivity|65.9|||||TWO_SIDED|95.0|63.5|68.2||||||||68.2|63.5|
71756211|NCT00664443|143015645|OTHER||Specificity|32.3|||||TWO_SIDED|95.0|29.0|35.9||||||||35.9|29.0|
71756212|NCT04586205|143015667|OTHER|||||||0.024|||||||ANOVA|||The baseline measurement for this analysis is the Sternberg Sorting Task (SST) at Baseline. This task is designed to assess how individuals store and retrieve random information from short-term memory. This task was administered to all participants before they were randomized into one of two groups (active TMS first then sham TMS or sham TMS first then active TMS).||||0.024
71756213|NCT04586205|143015668|OTHER||Mean Difference (Final Values)|0.02||||0.18|TWO_SIDED||||||t-test, 2 sided||The difference in means between High-Load IAPS (.69) and Low-Load IAPS (.67) in the group that received active then sham TMS.|The baseline measurement for this analysis is the International Affective Picture System (IAPS) at baseline. This is an emotional task using IAPS picture that will also compare low load and high load conditions. The number of images will vary by condition load, but for both the high-load \& low-load conditions, participants will look at IAPS pictures and answer questions about the images. We compare mean High-Load IAPS and Low-Load IAPS scores in the group that received active then sham TMS.||||0.18
71756214|NCT04586205|143015669|OTHER|||||||0.19|||||||Chi-squared|||The outcome measure for this analysis was the International Affective Picture System (IAPS).||||0.19
71756215|NCT04586205|143015670|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71756216|NCT04684836|143015671|SUPERIORITY|The analysis leveraged a difference-in-differences research design in an intent-to-treat framework, comparing outcomes for patients receiving care at high-telehealth practices with patients at comparable low-telehealth practices, before relative to after the onset of the pandemic (when telehealth use increased significantly).|Mean Difference (Net)|-0.0255||||0.0793|TWO_SIDED||||||Regression, Linear|All models included practice and year-quarter fixed effects, and clustered standard errors at the practice level.|This is the Unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|||||0.0793
71756217|NCT04684836|143015671|SUPERIORITY|Difference-in-differences model|Mean Difference (Net)|-0.0786||||0.5739|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||||||0.5739
71756218|NCT04684836|143015672|SUPERIORITY||Mean Difference (Net)|-0.0014||||0.3261|TWO_SIDED|||||This is an adjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences model||||0.3261
71756219|NCT04684836|143015672|SUPERIORITY||Mean Difference (Net)|0.0806|||<|0.01|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences model||||<0.01
71756220|NCT04684836|143015673|SUPERIORITY||Mean Difference (Net)|-0.0217||||0.1101|TWO_SIDED|||||This is an adjusted unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction.|Regression, Linear|||Difference-in-differences||||0.1101
71756221|NCT04684836|143015673|SUPERIORITY||Mean Difference (Net)|0.5551||||0.4618|TWO_SIDED|||||This is a fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.4618
71756222|NCT04684836|143015675|SUPERIORITY||Mean Difference (Net)|-0.0012||||0.8577|TWO_SIDED|||||This is an unadjusted model, which included only an indicator for high telemedicine practice, post-period, and its two-way interaction|Regression, Linear|||Difference-in-differences||||0.8577
71756223|NCT04684836|143015675|SUPERIORITY||Mean Difference (Net)|0.2014||||0.5954|TWO_SIDED|||||This is the fully adjusted regression model, which controlled for patient age group, gender, dual status, race, average percent of 65+ patients, risk score category, rural vs urban, and zip-code level characteristics.|Regression, Linear|||Difference-in-differences||||0.5954
71756224|NCT04328077|143015793|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|9.44||0.7755|TWO_SIDED|95.0|-16.1|21.5|||ANCOVA|||||21.5|-16.1|0.7755
71756225|NCT04328077|143015793|SUPERIORITY||Mean Difference (Final Values)|-12.66|STANDARD_ERROR_OF_MEAN|9.369||0.1798|TWO_SIDED|95.0|-31.3|5.9|||ANCOVA|||||5.9|-31.3|0.1798
71756226|NCT04328077|143015793|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.807||0.4229|TWO_SIDED|95.0|-27.4|11.6|||ANCOVA|||||11.6|-27.4|0.4229
71756227|NCT01347112|143015832|SUPERIORITY_OR_OTHER|||||||0.034||||||1 tailed fisher's exact test|Fisher Exact|1 tailed||||||0.034
71756228|NCT01347112|143015833|SUPERIORITY_OR_OTHER|||||||0.044||||||1 tailed fisher's exact|Fisher Exact|1 tailed||||||0.044
71756229|NCT01347112|143015834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|90.0|-4.7|2.1|||||data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate|||2.1|-4.7|
71756230|NCT00313014|143015860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.163|<|0.001|TWO_SIDED|95.0|-0.99|-0.35||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.35|-0.99|<.001
71756231|NCT00313014|143015860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.161|<|0.001|TWO_SIDED|95.0|-1.07|-0.44||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effect.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.44|-1.07|<.001
71756232|NCT00313014|143015861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.006|TWO_SIDED|95.0|-0.9|-0.13||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.13|-0.90|.006
71788219|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|0.4|1.01||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.01|0.40|
71788220|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.19|0.4||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.40|-0.19|
71788221|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.1|0.49||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.49|-0.10|
71788222|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.16|0.43||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.43|-0.16|
71788223|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|0.41|1.06||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.06|0.41|
71788224|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.01|0.64||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.64|0.01|
71788225|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.01|0.62||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.62|-0.01|
71788226|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|0.08|0.71||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.71|0.08|
71837269|NCT04258709|143181270|SUPERIORITY||Odds Ratio (OR)|0.7573||||0.3835|TWO_SIDED|95.0|0.4029|1.4138|||Regression, Logistic|||||1.4138|.4029|.3835
71837270|NCT04258709|143181271|SUPERIORITY||Odds Ratio (OR)|0.784||||0.459|TWO_SIDED|95.0|0.409|1.4912|||Regression, Logistic|||||1.4912|.409|.459
71837271|NCT04258709|143181272|SUPERIORITY||Odds Ratio (OR)|0.9338||||0.8499|TWO_SIDED|95.0|0.458|1.9039|||Regression, Logistic|||||1.9039|.458|.8499
71837272|NCT05324124|143181283|OTHER||Ratio of Geometric Least Squares Mean|0.952|||||TWO_SIDED|90.0|0.876|1.03||||||||1.03|0.876|
71837273|NCT05324124|143181284|OTHER||Ratio of Geometric Least Squares Mean|0.949|||||TWO_SIDED|90.0|0.869|1.04||||||||1.04|0.869|
71837274|NCT05324124|143181285|OTHER||Ratio of Geometric Least Squares Mean|0.829|||||TWO_SIDED|90.0|0.744|0.925||||||||0.925|0.744|
71892180|NCT00310310|143305898|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 1 sided|||||||0.08
71892181|NCT00310310|143305899|SUPERIORITY_OR_OTHER|||||||0.38|||||||t-test, 1 sided|||||||0.38
71892182|NCT00363415|143305900|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||<|0.01||95.0|1.27|1.92|||Log Rank|||||1.92|1.27|<0.01
71892183|NCT00363415|143305901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sex: Male|Log Rank|||||||<0.001
71892184|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Sex: Female|Log Rank|||||||0.023
71892185|NCT00363415|143305901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Race: Caucasian.|Log Rank|||||||<0.001
71756233|NCT00313014|143015861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.158|TWO_SIDED|95.0|-0.7|0.09||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took \> 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.09|-0.70|.158
71756234|NCT00313014|143015862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.065|TWO_SIDED|95.0|-3.55|0.11||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||0.11|-3.55|.065
71756235|NCT00313014|143015862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.031||95.0|-3.79|-0.18||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-0.18|-3.79|.031
71756236|NCT00313014|143015863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.735|<|0.001|TWO_SIDED|95.0|-9.64|-2.82||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed linear model: treatment, time as fixed effects, screening, prerandomization sleep disturbance subscale as covariates; subject as a random effect||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.||-2.82|-9.64|<.001
71756237|NCT00313014|143015863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.65|STANDARD_ERROR_OF_MEAN|1.709||0.121||95.0|-6.01|0.7||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that BTDS 20 arm was different from the BTDS 5 arm.||0.70|-6.01|.121
71788227|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|90.0|0.92|1.61||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.61|0.92|
71788228|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.04|0.76||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.76|0.04|
71892186|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for Race: Non-Caucasian.|Log Rank|||||||0.030
71756238|NCT01181349|143015865|SUPERIORITY_OR_OTHER||||||=|0.169|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.169
71756239|NCT01181349|143015867|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher's Exact Test. All tests were performed at a significance level of 0.05.||||=0.01
71892187|NCT00363415|143305901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.|Log Rank|||||||<0.001
71892188|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.|Log Rank|||||||0.519
71892189|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||P-value for Region: United States.|Log Rank|||||||0.084
71892190|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Region: European Union.|Log Rank|||||||0.001
71892191|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Region: Intercontinental Region.|Log Rank|||||||0.003
71892192|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for LDH (lactate dehydrogenase): \>Upper Limit of Normal.|Log Rank|||||||0.005
71892193|NCT00363415|143305901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Age: \<=65 years.|Log Rank|||||||<0.001
71892194|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Age: \>65 years.|Log Rank|||||||0.013
71892195|NCT00363415|143305901|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Number Metastatic Sites: \<=2.|Log Rank|||||||0.092
71892196|NCT00363415|143305901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Number Metastatic Sites: \>=3.|Log Rank|||||||<0.001
71892197|NCT00363415|143305901|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for History of Brain Metastases: No.|Log Rank|||||||<0.001
71892198|NCT03464045|143305924|OTHER||Hazard Ratio (HR)|0.8||||0.122|TWO_SIDED|95.0|0.61|1.06|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.06|0.61|0.122
71671232|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.1|0.0005
71671233|NCT03349060|142860133|SUPERIORITY||Difference in LS mean|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-2.9|<0.0001
71671234|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-10.9|||<|0.0001|TWO_SIDED|95.0|-14.8|-7.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.0|-14.8|<0.0001
71671235|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-18.9|||<|0.0001|TWO_SIDED|95.0|-22.7|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-15.1|-22.7|<0.0001
71671236|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.8|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.8|-17.3|<.0001
71788229|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.03|0.69||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.69|-0.03|
71788230|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|0.05|0.77||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|0.05|
71837275|NCT03771898|143181378|SUPERIORITY|Survival probability free of loss of locomotion estimated up to Week 106 (or two years).|Difference in survival probability (%)|-2.2|||=|0.585|TWO_SIDED|95.0|-22.2|17.7||One-sided, over time intervals during entire follow-up. Stratified generalized log-rank test was used, where matching identification created from matching process in SAS PSMATCH Procedure used as strata.|Log Rank||For the shared time interval up to Week 106 (or two years).|Interval censoring survival analysis.||17.7|-22.2|=0.585
71837276|NCT05563246|143181405|SUPERIORITY||LS Mean Difference (Final Values)|-47.61|||<|0.001|TWO_SIDED|95.0|-57.68|-35.14|||Mixed Models Analysis|||||-35.14|-57.68|<.001
71671237|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-22.1|||<|0.0001|TWO_SIDED|95.0|-26.8|-17.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-17.3|-26.8|<.0001
71671238|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.5|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-9.0|-19.5|<.0001
71671239|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-22.0|||<|0.0001|TWO_SIDED|95.0|-27.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.7|-27.2|<.0001
71671240|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-13.3|||<|0.0001|TWO_SIDED|95.0|-19.0|-7.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-7.7|-19.0|<0.0001
71671241|NCT03349060|142860134|SUPERIORITY||Difference in LS mean|-21.9|||<|0.0001|TWO_SIDED|95.0|-27.5|-16.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-16.3|-27.5|<.0001
71837277|NCT05563246|143181405|SUPERIORITY||LS Mean Difference (Final Values)|-81.66|||<|0.001|TWO_SIDED|95.0|-84.62|-78.13|||Mixed Models Analysis|||||-78.13|-84.62|<.001
71671242|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|22.3||||0.0028|TWO_SIDED|95.0|8.7|35.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.9|8.7|0.0028
71671243|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|40.1|||<|0.0001|TWO_SIDED|95.0|27.1|53.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.2|27.1|<0.0001
71671244|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|17.1||||0.0217|TWO_SIDED|95.0|2.8|31.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.4|2.8|0.0217
71671245|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|32.2|||<|0.0001|TWO_SIDED|95.0|18.5|45.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||45.9|18.5|<0.0001
71756240|NCT01391546|143015885|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was achieved if the lower bound of the 2-sided 95% confidence interval (CI) for the GMT ratio was greater than 2/3|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18|||longitudinal regression model|Model adjusted for pre-vaccination titres and age at vaccination in years|GMT ratio = GMT IM route divided by GMT SC route|||1.18|0.93|<0.001
71788231|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.92|1.68||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.68|0.92|
71788232|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.16|0.95||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.95|0.16|
71837278|NCT05563246|143181405|SUPERIORITY||LS Mean Difference (Final Values)|-85.77|||<|0.001|TWO_SIDED|95.0|-88.03|-83.09|||Mixed Models Analysis|||||-83.09|-88.03|<.001
71837279|NCT05563246|143181406|SUPERIORITY||LS Mean Difference (Final Values)|-40.38|||<|0.001|TWO_SIDED|95.0|-50.45|-28.27|||Mixed Models Analysis|||||-28.27|-50.45|<.001
71756241|NCT01391546|143015886|SUPERIORITY_OR_OTHER||GMFR|2.7|||||TWO_SIDED|95.0|2.4|3.0|||||GMFR = GMT Post-vaccination/GMT Pre-vaccination|Acceptability was demonstrated if the lower bound of the two-sided 95% CI was \>1.4||3.0|2.4|
71756242|NCT01744977|143015907|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.300
71756243|NCT01744977|143015908|NON_INFERIORITY_OR_EQUIVALENCE|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.|Mean Difference (Final Values)|-0.7||||0.839|TWO_SIDED|95.0|-8.0|6.5||As measured at 12m|Mixed Models Analysis||This value summarizes the full 12 month period so Mean Difference (Final Values) is appropriate.|||6.5|-8.0|0.839
71756244|NCT04090203|143015950|SUPERIORITY||Percentage|75.0||||0.001|ONE_SIDED|95.0|40.0|||The test was performed at a one-sided significance level of 0.05.|Exact binomial test|The null hypothesis of the exact binomial test was that the percentage of patients who were successfully desensitized was less than or equal to 20%.|The percentage of successfully desensitized participants is presented with a one-sided 95% CI, obtained from the lower bound of the two-sided 90% Clopper-Pearson exact confidence interval.|The null hypothesis was that the percentage of patients who were successfully desensitized was less than or equal to 20%, and the alternative hypothesis was that this percentage was greater than 20%. Assuming 80% of study participants would be successfully desensitized, a sample size of 10 patients would provide greater than 90% power to reject the null hypothesis using a one-sided exact binomial test with a significance level of 0.05.|||40.0|0.001
71756245|NCT04225897|143015983|OTHER||Difference|-8.02|||||TWO_SIDED|95.0|-31.78|15.74||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||15.74|-31.78|
71756246|NCT04225897|143015983|OTHER||Difference|-15.22|||||TWO_SIDED|95.0|-40.15|9.7|||Mixed effects analysis of covariance|||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||9.70|-40.15|
71756247|NCT04225897|143015984|OTHER||Difference|14.82|||||TWO_SIDED|95.0|-91.68|121.33||||||60 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||121.33|-91.68|
71756248|NCT04225897|143015984|OTHER||Difference|-31.19|||||TWO_SIDED|95.0|-143.96|81.57||||||156 hours. Analysis was performed using mixed effects analysis of covariance model on change from baseline in viral load, including a random effect for participant and fixed effects for treatment group, baseline human rhinovirus/enterovirus status (present or absent), visit, vist by treatment group interaction, and baseline viral load as a covariate.||81.57|-143.96|
71756249|NCT01285323|143016031|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.4063|||<|0.0001|TWO_SIDED|95.0|0.2819|0.5855||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5855|0.2819|<0.0001
71756250|NCT01285323|143016032|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.0397||0.0109|TWO_SIDED|95.0|0.023|0.179||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.179|0.023|0.0109
71756251|NCT01285323|143016033|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.093|STANDARD_ERROR_OF_MEAN|0.0317||0.0037|TWO_SIDED|95.0|0.03|0.155||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active-placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.155|0.030|0.0037
71671246|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|15.7||||0.0363|TWO_SIDED|95.0|1.4|30.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.0|1.4|0.0363
71671247|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|23.7||||0.0011|TWO_SIDED|95.0|9.8|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|9.8|0.0011
71788233|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.17|0.97||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.97|0.17|
71788234|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.24|1.03||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.03|0.24|
71788235|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|0.97|1.78||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.78|0.97|
71788236|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.08|0.92||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.92|0.08|
71788237|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.03|0.84||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.84|-0.03|
71788238|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.09|0.93||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.93|0.09|
71788239|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|0.75|1.59||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.59|0.75|
71788240|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.27|0.72||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.72|-0.27|
71788241|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.37|0.65||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.65|-0.37|
71788242|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-0.23|0.77||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.77|-0.23|
71788243|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|0.33|1.31||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.31|0.33|
71788244|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.24|0.89||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.89|-0.24|
71788245|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.25|0.94||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.94|-0.25|
71788246|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.31|0.8||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.80|-0.31|
71837280|NCT05563246|143181406|SUPERIORITY||LS Mean Difference (Final Values)|-69.95|||<|0.001|TWO_SIDED|95.0|-74.23|-64.96|||Mixed Models Analysis|||||-64.96|-74.23|<.001
71837281|NCT05563246|143181406|SUPERIORITY||LS Mean Difference (Final Values)|-68.9|||<|0.001|TWO_SIDED|95.0|-73.27|-63.81|||Mixed Models Analysis|||||-63.81|-73.27|<.001
71671248|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|20.1||||0.008|TWO_SIDED|95.0|5.8|34.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||34.5|5.8|0.0080
71671249|NCT03349060|142860135|SUPERIORITY||Difference in Percentage|29.1|||<|0.0001|TWO_SIDED|95.0|15.0|43.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|15.0|<0.0001
71671250|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.4|-2.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.2|-5.4|<0.0001
71671251|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.9|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.9|-7.1|<0.0001
71671252|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-3.3||||0.0001|TWO_SIDED|95.0|-5.0|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.7|-5.0|0.0001
71671253|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.8|-4.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.5|-7.8|<.0001
71671254|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-2.8||||0.0075|TWO_SIDED|95.0|-4.8|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.8|0.0075
71756252|NCT01285323|143016034|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.937||0.0259|TWO_SIDED|95.0|0.025|0.393||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.393|0.025|0.0259
71788247|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|0.08|1.19||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||1.19|0.08|
71788248|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|0.07|0.83||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.83|0.07|
71671255|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-3.3|-7.4|<0.0001
71671256|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-2.8||||0.0072|TWO_SIDED|95.0|-4.8|-0.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.8|-4.8|0.0072
71671257|NCT03349060|142860136|SUPERIORITY||Difference in LS mean|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.9|-2.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.9|-6.9|<0.0001
71788249|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-0.36|0.44||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.44|-0.36|
71671258|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-1.3||||0.275|TWO_SIDED|95.0|-3.5|1.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||1.0|-3.5|0.2750
71671259|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-2.5||||0.028|TWO_SIDED|95.0|-4.8|-0.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-4.8|0.0280
71671260|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-3.5||||0.0051|TWO_SIDED|95.0|-5.9|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-5.9|0.0051
71671261|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-6.4|||<|0.0001|TWO_SIDED|95.0|-8.8|-4.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.0|-8.8|<0.0001
71892199|NCT03464045|143305924|OTHER||Hazard Ratio (HR)|0.89||||0.417|TWO_SIDED|95.0|0.67|1.18|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.18|0.67|0.417
71892200|NCT03464045|143305924|OTHER||Hazard Ratio (HR)|0.88||||0.376|TWO_SIDED|95.0|0.66|1.17|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.17|0.66|0.376
71671262|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-2.1||||0.1706|TWO_SIDED|95.0|-5.1|0.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.9|-5.1|0.1706
71671263|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.4|-7.4|0.0048
71788250|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-0.07|0.68||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.68|-0.07|
71788251|NCT01529346|143074319|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.32|0.45||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.||0.45|-0.32|
71788252|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.43|3.71||||||SPID(6): LS mean estimate of the treatment difference along with 90% confidence interval (CI) were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.71|0.43|
71788253|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|1.69|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.05|3.33||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.33|0.05|
71788254|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|2.34|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|0.69|3.99||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||3.99|0.69|
71788255|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|6.99|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|5.19|8.79||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||8.79|5.19|
71788256|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|1.97|17.63||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||17.63|1.97|
71788257|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|3.55|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|90.0|-4.28|11.37||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||11.37|-4.28|
71788258|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|10.82|STANDARD_ERROR_OF_MEAN|4.76|||TWO_SIDED|90.0|2.97|18.68||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||18.68|2.97|
71788259|NCT01529346|143074320|SUPERIORITY_OR_OTHER||LS Mean Difference|22.39|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|13.82|30.97||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.||30.97|13.82|
71788260|NCT01529346|143074321|SUPERIORITY_OR_OTHER||LS Mean Difference|12.26|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|1.26|23.27||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||23.27|1.26|
71788261|NCT01529346|143074321|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|STANDARD_ERROR_OF_MEAN|6.66|||TWO_SIDED|90.0|-6.82|15.18||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.||15.18|-6.82|
71788262|NCT01529346|143074321|SUPERIORITY_OR_OTHER||LS Mean Difference|12.57|STANDARD_ERROR_OF_MEAN|6.69|||TWO_SIDED|90.0|1.52|23.61||||||||23.61|1.52|
71788263|NCT01529346|143074321|SUPERIORITY_OR_OTHER||LS Mean Difference|32.56|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|90.0|20.51|44.61||||||||44.61|20.51|
71788264|NCT01529346|143074322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|90.0|0.6|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.5|0.6|
71788265|NCT01529346|143074322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|90.0|0.9|1.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.9|0.9|
71756253|NCT01285323|143016035|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.196|STANDARD_ERROR_OF_MEAN|0.0664||0.0032|TWO_SIDED|95.0|-0.327|-0.066||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||-0.066|-0.327|0.0032
71756254|NCT01285323|143016036|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.353|0.67|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.||0.670|0.353|<0.0001
71756255|NCT01285323|143016037|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.012||0.0037|TWO_SIDED|95.0|0.011|0.059||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.059|0.011|0.0037
71756256|NCT01285323|143016038|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.1775||0.7263|TWO_SIDED|95.0|-0.411|0.287||Statistical significance at \<=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p\>0.05, no further comparisons were interpreted inferentially.||0.287|-0.411|0.7263
71756257|NCT01285323|143016041|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio (reslizumab vs placebo)|0.3893|||<|0.0001|TWO_SIDED|95.0|0.2621|0.5782||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||0.5782|0.2621|<0.0001
71756258|NCT01285323|143016041|SUPERIORITY_OR_OTHER_LEGACY||CAE rate ratio|0.6686||||0.402|TWO_SIDED|95.0|0.2878|1.6479||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.||1.6479|0.2878|0.4020
71756259|NCT02703597|143016045|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8|TWO_SIDED|95.0|0.32|4.2|||Mixed Models Analysis|||"Hypothesis: Participants in the GSA-ASPIRE-Network Group will be more likely to decrease in susceptibility to vaping than participants in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||4.20|0.32|0.80
71756260|NCT02703597|143016045|SUPERIORITY||Odds Ratio (OR)|0.17|||<|0.01|TWO_SIDED|95.0|0.06|0.43|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility to vaping over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.43|0.06|<0.01
71756261|NCT02703597|143016046|SUPERIORITY||Odds Ratio (OR)|0.76||||0.7|TWO_SIDED|95.0|0.16|3.49|||Mixed Models Analysis|||"Hypothesis: Adolescents who participated in the GSA-ASPIRE-Network group will be more likely to decrease in susceptibility to using conventional tobacco than adolescents who participated in the ASPIRE group.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||3.49|0.16|0.70
71788266|NCT01529346|143074322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.7|1.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.6|0.7|
71788267|NCT01529346|143074322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||||TWO_SIDED|90.0|1.0|2.4||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||2.4|1.0|
71788268|NCT01529346|143074323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|90.0|1.1|3.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||3.8|1.1|
71788269|NCT01529346|143074323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6|||||TWO_SIDED|90.0|1.4|4.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.9|1.4|
71837282|NCT05563246|143181407|SUPERIORITY||Risk Difference (RD)|58.15|||<|0.001|TWO_SIDED|95.0|40.3|75.99|||Regression, Logistic|||||75.99|40.30|<.001
71837283|NCT05563246|143181407|SUPERIORITY||Risk Difference (RD)|89.87|||<|0.001|TWO_SIDED|95.0|81.54|98.2|||Regression, Logistic|||||98.20|81.54|<.001
71837284|NCT05563246|143181407|SUPERIORITY||Risk Difference (RD)|90.71|||<|0.001|TWO_SIDED|95.0|82.8|98.62|||Regression, Logistic|||||98.62|82.80|<.001
71837285|NCT05563246|143181408|SUPERIORITY||Risk Difference (RD)|35.18|||<|0.001|TWO_SIDED|95.0|18.9|51.46|||Regression, Logistic|||||51.46|18.90|<.001
71837286|NCT05563246|143181408|SUPERIORITY||Risk Difference (RD)|78.18|||<|0.001|TWO_SIDED|95.0|67.7|88.65|||Regression, Logistic|||||88.65|67.70|<.001
71837287|NCT05563246|143181408|SUPERIORITY||Risk Difference (RD)|73.62|||<|0.001|TWO_SIDED|95.0|63.65|83.58|||Regression, Logistic|||||83.58|63.65|<.001
71837288|NCT05563246|143181409|SUPERIORITY||LS Mean Difference (Final Values)|-8.94||||0.11|TWO_SIDED|95.0|-18.84|2.17|||Mixed Models Analysis|||||2.17|-18.84|0.110
71837289|NCT05563246|143181409|SUPERIORITY||LS Mean Difference (Final Values)|-13.05||||0.004|TWO_SIDED|95.0|-20.92|-4.4|||Mixed Models Analysis|||||-4.40|-20.92|0.004
71837290|NCT05563246|143181409|SUPERIORITY||LS Mean Difference (Final Values)|-16.13|||<|0.001|TWO_SIDED|95.0|-23.69|-7.84|||Mixed Models Analysis|||||-7.84|-23.69|<.001
71837291|NCT05563246|143181410|SUPERIORITY||LS Mean Difference (Final Values)|35.27||||0.131|TWO_SIDED|95.0|-8.63|100.27|||Mixed Models Analysis|||||100.27|-8.63|0.131
71837292|NCT05563246|143181410|SUPERIORITY||LS Mean Difference (Final Values)|8.32||||0.627|TWO_SIDED|95.0|-21.62|49.7|||Mixed Models Analysis|||||49.70|-21.62|0.627
71671264|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-2.5||||0.0629|TWO_SIDED|95.0|-5.2|0.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.1|-5.2|0.0629
71756262|NCT02703597|143016046|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.01|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||"Hypothesis: Participants in both arms will decrease in susceptibility of using conventional tobacco over time.~The statistical analysis was conducted for 10 out of the 15 participating sites, to avoid bias with respect to the sites that participated in different conditions (i.e., 1 site in a school classroom during class time and 4 sites in the summer camp during summer time)."||0.40|0.04|<0.01
71756263|NCT03418714|143016058|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||T test on the change in network activity across all networks, from before to after salvinorin A administration.||||.006
71756264|NCT03418714|143016059|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||T test on the change in within- and between-network connectivity across all values, from before to after salvinorin A administration.||||.001
71756265|NCT00089752|143016071|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was designed to achieve at least 80% power, using n 1⁄4 123 per group with an effect size of at least 0.36|Adjusted difference in mean change|-1.76||||0.09|TWO_SIDED|95.0|-3.8|0.3||a priori threshold was p\<0.05|ANCOVA|||Intent to Treat analysis with Last Observation Carried Forward.||0.3|-3.8|0.09
71837293|NCT05563246|143181410|SUPERIORITY||LS Mean Difference (Final Values)|-6.08||||0.701|TWO_SIDED|95.0|-31.89|29.51|||Mixed Models Analysis|||||29.51|-31.89|0.701
71837294|NCT02167867|143181414|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||t=+7.76||||<0.0001
71837295|NCT03420833|143181427|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71837296|NCT03420833|143181427|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
71756266|NCT03879772|143016083|SUPERIORITY|||||||0.95|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).||||0.95
71756267|NCT03879772|143016083|SUPERIORITY|||||||0.78|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.78
71756268|NCT03879772|143016083|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
71837297|NCT03420833|143181430|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
71837298|NCT03420833|143181432|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71837299|NCT03420833|143181432|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
71837300|NCT03336333|143181438|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.63||One-sided|Log Rank|||||0.63|0.28|<0.0001
71837301|NCT04927065|143181463|OTHER||Geometric Mean Ratio (GMR)|2.5|||||TWO_SIDED|95.0|2.0|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAB: Part A.2 versus Part A.1|||3.0|2.0|
71837302|NCT04927065|143181463|OTHER||GMR|2.0|||||TWO_SIDED|95.0|1.7|2.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||2.3|1.7|
71837303|NCT04927065|143181464|OTHER||Geometric Mean Ratio (GMR)|6.3|||||TWO_SIDED|95.0|4.5|8.9|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||8.9|4.5|
71837304|NCT04927065|143181464|OTHER||GMR|2.8|||||TWO_SIDED|95.0|2.1|3.6|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||3.6|2.1|
71837305|NCT04927065|143181465|OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.1|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||5.6|-3.1|
71837306|NCT04927065|143181465|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
71837307|NCT04927065|143181466|OTHER||Percentage Difference|-1.3|||||TWO_SIDED|95.0|-6.9|4.3|||||Omicron variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||4.3|-6.9|
71837308|NCT04927065|143181466|OTHER||Percentage Difference|-2.6|||||TWO_SIDED|95.0|-9.6|4.5|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||4.5|-9.6|
71837309|NCT04927065|143181467|OTHER||Percentage Difference|12.9|||||TWO_SIDED|95.0|4.1|21.6|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||21.6|4.1|
71837310|NCT04927065|143181467|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||||
71837311|NCT04927065|143181468|OTHER||Percentage Difference|2.9|||||TWO_SIDED|95.0|-11.4|17.1|||||Omicron BA.1 variant (B.1.1.529) nAb: Part A.2 versus Part A.1|||17.1|-11.4|
71837312|NCT04927065|143181468|OTHER||Percentage Difference|-7.1|||||TWO_SIDED|95.0|-21.6|7.3|||||SARS-CoV-2 (D614G) nAb: Part A.2 versus Part A.1|||7.3|-21.6|
71837313|NCT04927065|143181469|OTHER||GMR|1.777|||||TWO_SIDED|95.0|1.523|2.073|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.073|1.523|
71837314|NCT04927065|143181470|OTHER||Percentage Difference|0.6|||||TWO_SIDED|95.0|-1.7|3.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||3.0|-1.7|
71837315|NCT04927065|143181471|OTHER||Percentage Difference|17.9|||||TWO_SIDED|95.0|9.8|26.0|||||Omicron BA.1 Variant (B.1.1.529) nAb - Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||26.0|9.8|
71756269|NCT03879772|143016083|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71756270|NCT03879772|143016083|SUPERIORITY|||||||0.82|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.82
71837316|NCT04927065|143181472|OTHER||GMR|1.744|||||TWO_SIDED|97.5|1.492|2.04|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.040|1.492|
71837317|NCT04927065|143181472|OTHER||GMR|1.211|||||TWO_SIDED|97.5|1.074|1.366|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.366|1.074|
71837318|NCT04927065|143181473|OTHER||GMR|1.676|||||TWO_SIDED|97.5|1.396|2.013|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.013|1.396|
71756271|NCT03879772|143016083|SUPERIORITY|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.98
71756272|NCT03879772|143016083|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71756273|NCT03879772|143016083|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
71756274|NCT03879772|143016083|SUPERIORITY|||||||0.02|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.02
71756275|NCT03879772|143016083|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71756276|NCT03879772|143016084|SUPERIORITY|||||||0.56|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.56
71756277|NCT03879772|143016084|SUPERIORITY|||||||0.74|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.74
71756278|NCT03879772|143016084|SUPERIORITY|||||||0.68|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.68
71756279|NCT03879772|143016084|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756280|NCT03879772|143016084|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
71756281|NCT03879772|143016084|SUPERIORITY|||||||0.33|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.33
71756282|NCT03879772|143016084|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71756283|NCT03879772|143016084|SUPERIORITY|||||||0.46|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.46
71756284|NCT03879772|143016084|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756285|NCT03879772|143016084|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756286|NCT03879772|143016085|SUPERIORITY|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.8
71756287|NCT03879772|143016085|SUPERIORITY|||||||0.45|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.45
71756288|NCT03879772|143016085|SUPERIORITY|||||||0.12|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.12
71756289|NCT03879772|143016085|SUPERIORITY|||||||0.36|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.36
71756290|NCT03879772|143016085|SUPERIORITY|||||||0.6|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.6
71756291|NCT03879772|143016085|SUPERIORITY|||||||0.17|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.17
71756292|NCT03879772|143016085|SUPERIORITY|||||||0.23|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.23
71756293|NCT03879772|143016085|SUPERIORITY|||||||0.42|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.42
71756294|NCT03879772|143016085|SUPERIORITY|||||||0.09|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.09
71756295|NCT03879772|143016085|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71756296|NCT03879772|143016086|SUPERIORITY|||||||0.03|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.03
71756297|NCT03879772|143016086|SUPERIORITY|||||||0.04|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.04
71756298|NCT03879772|143016086|SUPERIORITY|||||||0.08|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.08
71756299|NCT03879772|143016086|SUPERIORITY|||||||0.49|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.49
71756300|NCT03879772|143016086|SUPERIORITY|||||||0.93|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.93
71756301|NCT03879772|143016086|SUPERIORITY|||||||0.75|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.75
71756302|NCT03879772|143016086|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756303|NCT03879772|143016086|SUPERIORITY|||||||0.71|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.71
71756304|NCT03879772|143016086|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71837319|NCT04927065|143181473|OTHER||GMR|1.105|||||TWO_SIDED|97.5|0.97|1.26|||||SARS-CoV-2 (D614G) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||1.260|0.970|
71837320|NCT04927065|143181474|OTHER||Percentage Difference|1.5|||||TWO_SIDED|97.5|-1.1|4.1|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||4.1|-1.1|
71837321|NCT04927065|143181475|OTHER||Percentage Difference|21.5|||||TWO_SIDED|97.5|12.8|30.2|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||30.2|12.8|
71671265|NCT03349060|142860137|SUPERIORITY||Difference in LS mean|-3.6||||0.01|TWO_SIDED|95.0|-6.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-6.2|0.0100
71671266|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|6.6||||0.1238|TWO_SIDED|95.0|-0.7|13.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||13.9|-0.7|0.1238
71671267|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|20.1||||0.0008|TWO_SIDED|95.0|11.0|29.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||29.2|11.0|0.0008
71671268|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|6.8||||0.2091|TWO_SIDED|95.0|-2.8|16.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.4|-2.8|0.2091
71671269|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|24.0||||0.0005|TWO_SIDED|95.0|12.9|35.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.0|12.9|0.0005
71756305|NCT03879772|143016086|SUPERIORITY|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.01
71788270|NCT01529346|143074323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.2|||||TWO_SIDED|90.0|1.1|4.1||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||4.1|1.1|
71756306|NCT03879772|143016087|SUPERIORITY|||||||0.16|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.16
71756307|NCT03879772|143016087|SUPERIORITY|||||||0.22|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.22
71788271|NCT01529346|143074323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.3|||||TWO_SIDED|90.0|2.8|9.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||9.9|2.8|
71788272|NCT01529346|143074324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|90.0|0.4|1.0||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.0|0.4|
71788273|NCT01529346|143074324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|90.0|0.5|1.2||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||1.2|0.5|
71788274|NCT01529346|143074324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||||TWO_SIDED|90.0|0.3|0.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.8|0.3|
71671270|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|9.1||||0.1161|TWO_SIDED|95.0|-0.9|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-0.9|0.1161
71756308|NCT03879772|143016087|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
71756309|NCT03879772|143016087|SUPERIORITY|||||||0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.14
71837322|NCT04927065|143181476|OTHER||Percentage Difference|1.8|||||TWO_SIDED|97.5|-1.9|5.6|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||5.6|-1.9|
71837323|NCT04927065|143181477|OTHER||Percentage Difference|20.6|||||TWO_SIDED|97.5|12.4|28.7|||||Omicron BA.1 Variant (B.1.1.529) nAb: Part G: mRNA-1273.214 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||28.7|12.4|
71837324|NCT04927065|143181478|OTHER||GMR|6.412|||||TWO_SIDED|95.0|5.369|7.658|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||7.658|5.369|
71756310|NCT03879772|143016087|SUPERIORITY|||||||0.85|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.85
71756311|NCT03879772|143016087|SUPERIORITY|||||||0.96|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.96
71756312|NCT03879772|143016087|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756313|NCT03879772|143016087|SUPERIORITY|||||||0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.81
71756314|NCT03879772|143016087|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756315|NCT03879772|143016087|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756316|NCT03879772|143016088|SUPERIORITY|||||||0.05|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.05
71756317|NCT03879772|143016088|SUPERIORITY|||||||0.07|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.07
71788275|NCT01529346|143074324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||||TWO_SIDED|90.0|0.2|0.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.||0.6|0.2|
71837325|NCT04927065|143181478|OTHER||GMR|1.967|||||TWO_SIDED|95.0|1.708|2.265|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||2.265|1.708|
71788276|NCT01500629|143074340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.156|TWO_SIDED|95.0|-1.9|0.33|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.33|-1.90|0.156
71788277|NCT01500629|143074341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.625|TWO_SIDED|95.0|-1.49|0.92|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.92|-1.49|0.625
71788278|NCT01500629|143074342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.291|TWO_SIDED|95.0|-2.12|0.67|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.67|-2.12|0.291
71788279|NCT01500629|143074343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.899|TWO_SIDED|95.0|-1.21|1.07|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.07|-1.21|0.899
71788280|NCT01500629|143074344|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.701||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.701
71788281|NCT01500629|143074345|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.108||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.108
71788282|NCT01500629|143074346|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.253||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.253
71788283|NCT01500629|143074347|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.287||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.287
71788284|NCT01500629|143074348|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.409||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.409
71788285|NCT01500629|143074349|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.092||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.092
71788286|NCT01500629|143074350|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.042||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.042
71788287|NCT01500629|143074351|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.307||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.307
71788288|NCT01500629|143074352|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.5||||0.903||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.903
71788289|NCT01500629|143074353|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.121||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.121
71837326|NCT04927065|143181479|OTHER||Percentage Difference|12.2|||||TWO_SIDED|95.0|6.9|17.4|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||17.4|6.9|
71837327|NCT04927065|143181479|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||||
71837328|NCT04927065|143181480|OTHER||Percentage Difference|54.7|||||TWO_SIDED|95.0|47.5|61.8|||||Omicron Variant (BA.4/BA.5) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||61.8|47.5|
71837329|NCT04927065|143181480|OTHER||Percentage Difference|37.6|||||TWO_SIDED|95.0|29.3|45.9|||||SARS-CoV-2 (D614G) nAb: Part H mRNA-1273.222 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||45.9|29.3|
71837330|NCT04927065|143181489|OTHER||GMR|0.836|||||TWO_SIDED|95.0|0.745|0.938|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||0.938|0.745|
71837331|NCT04927065|143181490|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|||||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg 95% CI could not be calculated due to the SRR difference is 0.|||||
71837332|NCT04927065|143181491|OTHER||SRR Difference|-13.1|||||TWO_SIDED|95.0|-21.2|-5.0|||||SARS-CoV-2 (D614G) nAb: Part F (Cohort 2): mRNA-1273.529 50 μg versus Part F (Cohort 2): mRNA-1273 50 μg|||-5.0|-21.2|
71837333|NCT04927065|143181492|OTHER||SRR Difference|0.0|||||TWO_SIDED|97.5|||||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273 95% CI could not be calculated due to the SRR difference is 0.|||||
71837334|NCT04927065|143181492|OTHER||SRR Difference|0.9|||||TWO_SIDED|97.5|-1.6|3.5|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||3.5|-1.6|
71837335|NCT04927065|143181492|OTHER||SRR Difference|-0.1|||||TWO_SIDED|95.0|-2.3|2.1|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.1|-2.3|
71892201|NCT03464045|143305925|OTHER||Hazard Ratio (HR)|0.79||||0.22|TWO_SIDED|95.0|0.55|1.15|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.15|0.55|0.220
71892202|NCT03464045|143305925|OTHER||Hazard Ratio (HR)|0.91||||0.628|TWO_SIDED|95.0|0.63|1.32|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.32|0.63|0.628
71756318|NCT03879772|143016088|SUPERIORITY|||||||0.11|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.11
71756319|NCT03879772|143016088|SUPERIORITY|||||||0.31|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.31
71837336|NCT04927065|143181492|OTHER||SRR Difference|-1.9|||||TWO_SIDED|95.0|-5.3|1.5|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.5|-5.3|
71837337|NCT04927065|143181493|OTHER||SRR Difference|10.9|||||TWO_SIDED|97.5|1.7|20.1|||||SARS-CoV-2 (D614G) nAb at Day 29: Part G versus Part F (Cohort 2) mRNA-1273|||20.1|1.7|
71837338|NCT04927065|143181493|OTHER||SRR Difference|9.2|||||TWO_SIDED|97.5|1.4|17.0|||||SARS-CoV-2 (D614G) nAb at Day 91: Part G versus Part F (Cohort 2) mRNA-1273|||17.0|1.4|
71837339|NCT04927065|143181493|OTHER||SRR Difference|10.1|||||TWO_SIDED|95.0|3.0|17.2|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||17.2|3.0|
71837340|NCT04927065|143181493|OTHER||SRR Difference|4.3|||||TWO_SIDED|95.0|-5.0|13.6|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||13.6|-5.0|
71837341|NCT04927065|143181495|OTHER||GMR|1.818|||||TWO_SIDED|95.0|1.469|2.249|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.249|1.469|
71837342|NCT04927065|143181497|OTHER||SRR Difference|0.0|||||TWO_SIDED|95.0|-2.6|2.5|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||2.5|-2.6|
71837343|NCT04927065|143181499|OTHER||SRR Difference|25.5|||||TWO_SIDED|95.0|16.9|34.1|||||SARS-CoV-2 (D614G) nAb: Part H versus Part F (Cohort 2) mRNA-1273|||34.1|16.9|
71756320|NCT03879772|143016088|SUPERIORITY|||||||0.94|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.94
71756321|NCT03879772|143016088|SUPERIORITY|||||||0.73|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.73
71756322|NCT03879772|143016088|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756323|NCT03879772|143016088|SUPERIORITY|||||||0.79|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||0.79
71756324|NCT03879772|143016088|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756325|NCT03879772|143016088|SUPERIORITY||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.||||<0.01
71756326|NCT00871975|143016101|SUPERIORITY_OR_OTHER||Sensitivity (percent)|80.6|||||TWO_SIDED||||||||We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
71756327|NCT00871975|143016101|SUPERIORITY_OR_OTHER||Specificity (percent)|28.1|||||TWO_SIDED||||||||We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.||||
71756328|NCT02668653|143016114|OTHER||Hazard Ratio (HR)|0.776||||0.0324|TWO_SIDED|95.0|0.615|0.979|||Log Rank|Stratification factors include region, age, and WBC count at the time of diagnosis of AML.||||0.979|0.615|0.0324
71756329|NCT00979940|143016124|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Chi-squared|||||||0.97
71756330|NCT01294553|143016126|SUPERIORITY_OR_OTHER||Percentage of participants|15.4|||||TWO_SIDED|95.0|12.8|18.1|||||The estimated value represents the percentage of participants with an adverse event.|||18.1|12.8|
71756331|NCT00926237|143016138|SUPERIORITY||Mean Difference (Final Values)|-5.74||||0.04|ONE_SIDED|||||t value = -1.40|Mixed Models Analysis||1Hz active rTMS - Sham rTMS|||||.04
71788290|NCT01500629|143074354|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.689||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.689
71788291|NCT01500629|143074355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.314||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.314
71788292|NCT01500629|143074356|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.8||||0.034||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.034
71788293|NCT01500629|143074357|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.845||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.845
71788294|NCT01500629|143074358|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.619||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.619
71788295|NCT01500629|143074359|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.803||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.803
71788296|NCT01500629|143074360|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.175||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.175
71788297|NCT01500629|143074361|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.206|||||||Wilcoxon (Mann-Whitney)|The rank sum test was based on period difference for comparison between sequence.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.206
71788298|NCT01500629|143074362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.072||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||0.072
71788299|NCT01500629|143074363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.014||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||||.0140
71788300|NCT01500629|143074364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.907|TWO_SIDED|95.0|-0.24|0.22|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.22|-0.24|0.907
71837344|NCT04927065|143181500|OTHER||SRR Difference|5.0|||||TWO_SIDED|95.0|0.3|9.8|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||9.8|0.3|
71837345|NCT04927065|143181500|OTHER||SRR Difference|5.6|||||TWO_SIDED|95.0|-0.3|11.5|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||11.5|-0.3|
71837346|NCT04927065|143181501|OTHER||SRR Difference|14.5|||||TWO_SIDED|95.0|6.7|22.3|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||22.3|6.7|
71756332|NCT00926237|143016138|SUPERIORITY||Mean Difference (Final Values)|-6.77||||0.02|ONE_SIDED|||||t value = -2.03|Mixed Models Analysis||10 Hz active rTMS - Sham rTMS|||||.02
71756333|NCT00926237|143016138|SUPERIORITY||Mean Difference (Final Values)|-4.73||||0.2|ONE_SIDED|||||t value = -1..28|Mixed Models Analysis||10 Hz washout - sham washout period|||||.20
71756334|NCT00926237|143016138|SUPERIORITY||Mean Difference (Final Values)|-5.19||||0.19|ONE_SIDED|||||t value = -1.29|Mixed Models Analysis||1Hz washout - sham washout|||||.19
71756335|NCT00632229|143016145|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
71756336|NCT00632229|143016146|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.||||<0.05
71756337|NCT05386329|143016148|SUPERIORITY|Comparison of mid-treatment to end-of-treatment|Mean Difference (Final Values)|1.0308|STANDARD_ERROR_OF_MEAN|0.5485|=|0.0719|TWO_SIDED|95.0|-0.09883|2.1605||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CSQ-8 score compared to the end-point (week 8) CSQ-8 score.|Null hypothesis: there is no significant difference in CSQ-8 total scores between midpoint (week 4) and end-of-treatment (week 8).||2.1605|-0.09883|=.0719
71756338|NCT05386329|143016149|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline|Mean Difference (Final Values)|0.4296|STANDARD_ERROR_OF_MEAN|0.8857|=|0.6316|TWO_SIDED|95.0|-1.3884|2.2475||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ credibility score compared to the baseline (week 0) CEQ credibility score.|Null hypothesis: there is no significant difference in treatment credibility total scores between baseline (week 0) and midpoint (week 4).||2.2475|-1.3884|=.6316
71788301|NCT01500629|143074365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.666|TWO_SIDED|95.0|-0.28|0.18|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.18|-0.28|0.666
71788302|NCT01500629|143074366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.972|TWO_SIDED|95.0|-0.29|0.28|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.28|-0.29|0.972
71788303|NCT01500629|143074367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.521|TWO_SIDED|95.0|-0.31|0.59|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.59|-0.31|0.521
71788304|NCT01500629|143074368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.376|TWO_SIDED|95.0|-0.15|0.39|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.39|-0.15|0.376
71788305|NCT01500629|143074369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.35|TWO_SIDED|95.0|-0.11|0.3|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.30|-0.11|0.350
71788306|NCT01500629|143074370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.36|0.34|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.34|-0.36|0.947
71788307|NCT01500629|143074371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.651|TWO_SIDED|95.0|-0.3|0.19|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.19|-0.30|0.651
71788308|NCT01500629|143074376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.261|TWO_SIDED|95.0|-1.3|0.38|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.38|-1.30|0.261
71788309|NCT01500629|143074377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.481|TWO_SIDED|95.0|-0.51|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.51|0.481
71788310|NCT01500629|143074378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.961|TWO_SIDED|95.0|-0.85|0.89|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||0.89|-0.85|0.961
71788311|NCT01500629|143074379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.546|TWO_SIDED|95.0|-0.57|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.||1.04|-0.57|0.546
71788312|NCT03454581|143074391|SUPERIORITY||Mean Difference (Final Values)|0.05|||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
71837347|NCT04927065|143181501|OTHER||SRR Difference|8.0|||||TWO_SIDED|95.0|-2.1|18.0|||||Omicron BA.1 Variant (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||18.0|-2.1|
71671271|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|26.5||||0.0002|TWO_SIDED|95.0|15.3|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.7|15.3|0.0002
71671272|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|8.1||||0.1837|TWO_SIDED|95.0|-2.8|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||19.1|-2.8|0.1837
71788313|NCT03454581|143074392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71788314|NCT03454581|143074393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71788315|NCT03454581|143074394|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Generalized Estimating Equation|||||||<0.05
71788316|NCT03454581|143074395|OTHER||||||<|0.01|||||||Generalized Estimating Equation|||||||<0.01
71788317|NCT03454581|143074396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71788318|NCT03454581|143074397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71788319|NCT03454581|143074398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Generalized Estimating Equation|||||||0.05
71788320|NCT02902965|143074399|OTHER||median PFS|8.5|||||TWO_SIDED|95.0|6.2|10.8|||||Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||10.8|6.2|
71788321|NCT02902965|143074400|OTHER||ORR in %|56.8|||||TWO_SIDED|95.0|44.7|68.2|||||Overall response = confirmed sCR + CR + VGPR + PR with corresponding 95% Exact binomial Cl|||68.2|44.7|
71671273|NCT03349060|142860138|SUPERIORITY||Difference in Percentage|19.8||||0.0046|TWO_SIDED|95.0|8.1|31.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||31.6|8.1|0.0046
71788322|NCT02902965|143074401|OTHER||PFS rate|6.6|||||TWO_SIDED|95.0|1.6|16.9|||||Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.|||16.9|1.6|
71788323|NCT02902965|143074404|OTHER||median TTP|10.6|||||TWO_SIDED|95.0|7.8|12.0|||||KM estimates for median TTP with associated 95% CI|||12|7.8|
71788324|NCT01067456|143074412|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.57||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
71788325|NCT00799487|143074420|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-27.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-20.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.2|-34.4|<0.0001
71788326|NCT00799487|143074421|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.1|-20.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||-20.8|-35.1|<0.0001
71788327|NCT00799487|143074422|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.0|||<|0.0001|TWO_SIDED|95.0|3.4|6.6||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||6.6|3.4|<0.0001
71788328|NCT00799487|143074423|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|||<|0.0001|TWO_SIDED|95.0|3.2|5.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||5.8|3.2|<0.0001
71788329|NCT00799487|143074424|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|9.5|||<|0.0001|TWO_SIDED|95.0|6.9|12.0||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta|||12.0|6.9|<0.0001
71788330|NCT00799487|143074425|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.51|||<|0.0001|TWO_SIDED|95.0|-4.27|-2.74||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-2.74|-4.27|<0.0001
71788331|NCT00799487|143074426|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.58|||<|0.0001|TWO_SIDED|95.0|-23.72|-11.45||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.45|-23.72|<0.0001
71788332|NCT00799487|143074427|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-30.33|||<|0.0001|TWO_SIDED|95.0|-39.29|-21.37||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-21.37|-39.29|<0.0001
71788333|NCT00799487|143074428|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13||||0.0297|TWO_SIDED|95.0|-2.15|-0.12||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.12|-2.15|0.0297
71788334|NCT00799487|143074429|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84||||0.0955|TWO_SIDED|95.0|-1.84|0.15||P-values were determined by using a general linear mixed model. Finger Windows Forwards was the first non-significant p-value in the gatekeeper sequence.|Mixed Models Analysis|Testing of additional endpoints in the sequence was still performed without any unqualified statements about the individual statistical significance.|Placebo minus Concerta|||0.15|-1.84|0.0955
71788335|NCT00799487|143074430|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.37||||0.0002|TWO_SIDED|95.0|-21.52|-7.23||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-7.23|-21.52|0.0002
71788336|NCT00799487|143074431|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26||||0.2335|TWO_SIDED|95.0|-0.7|0.17||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.17|-0.70|0.2335
71788337|NCT00799487|143074432|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.51||||0.2321|TWO_SIDED|95.0|-6.67|1.65||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||1.65|-6.67|0.2321
71788338|NCT00799487|143074433|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.52||||0.0015|TWO_SIDED|95.0|-5.64|-1.4||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.40|-5.64|0.0015
71788339|NCT00799487|143074434|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.38||||0.0101|TWO_SIDED|95.0|-9.43|-1.33||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-1.33|-9.43|0.0101
71788340|NCT00799487|143074435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09||||0.6642|TWO_SIDED|95.0|-0.53|0.34||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.34|-0.53|0.6642
71788341|NCT00799487|143074436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-35.3||||0.004|TWO_SIDED|95.0|-58.89|-11.71||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-11.71|-58.89|0.0040
71788342|NCT00799487|143074437|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08||||0.0012|TWO_SIDED|95.0|-0.14|-0.03||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.03|-0.14|0.0012
71788343|NCT00799487|143074438|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07||||0.0051|TWO_SIDED|95.0|-0.12|-0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||-0.02|-0.12|0.0051
71788344|NCT00799487|143074439|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05||||0.1768|TWO_SIDED|95.0|-0.13|0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.02|-0.13|0.1768
71788345|NCT00799487|143074440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02||||0.4245|TWO_SIDED|95.0|-0.09|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.09|0.4245
71788346|NCT00799487|143074441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.0||||0.9729|TWO_SIDED|95.0|-0.09|0.09||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.09|-0.09|0.9729
71788347|NCT00799487|143074442|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04||||0.3486|TWO_SIDED|95.0|-0.12|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.04|-0.12|0.3486
71788348|NCT00799487|143074443|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03||||0.1466|TWO_SIDED|95.0|-0.07|0.01||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.01|-0.07|0.1466
71788349|NCT00799487|143074444|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03||||0.1368|TWO_SIDED|95.0|-0.01|0.08||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta|||0.08|-0.01|0.1368
71788350|NCT03070782|143074452|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0032|TWO_SIDED|95.0|-46.0|-12.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-12|-46|0.0032
71788351|NCT03070782|143074452|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-41.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-41|-64|<.0001
71788352|NCT03070782|143074452|SUPERIORITY||Mean Difference in % CFB|-70.0|||<|0.0001|TWO_SIDED|95.0|-77.0|-62.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-62|-77|<.0001
71788353|NCT03070782|143074452|SUPERIORITY||Mean Difference in % CFB|-56.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-43.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-43|-65|<.0001
71788354|NCT03070782|143074452|SUPERIORITY||Mean Difference in % CFB|-78.0|||<|0.0001|TWO_SIDED|95.0|-83.0|-72.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-72|-83|<.0001
71788355|NCT03070782|143074456|SUPERIORITY||Mean Difference in % CFB|-6.0||||0.4407|TWO_SIDED|95.0|-19.0|9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||9|-19|0.4407
71788356|NCT03070782|143074456|SUPERIORITY||Mean Difference in % CFB|-25.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-13.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-13|-35|<.0001
71788357|NCT03070782|143074456|SUPERIORITY||Mean Difference in % CFB|-14.0||||0.0368|TWO_SIDED|95.0|-26.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-26|0.0368
71788358|NCT03070782|143074456|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0216|TWO_SIDED|95.0|-28.0|-3.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-3|-28|0.0216
71788359|NCT03070782|143074456|SUPERIORITY||Mean Difference in % CFB|-22.0||||0.0012|TWO_SIDED|95.0|-33.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-33|0.0012
71788360|NCT03070782|143074457|SUPERIORITY||Odds Ratio (OR)|4.98||||0.0286|TWO_SIDED|95.0|1.2|21.0|||Regression, Logistic|||||21.0|1.2|0.0286
71788361|NCT03070782|143074457|SUPERIORITY||Odds Ratio (OR)|31.07|||<|0.0001|TWO_SIDED|95.0|7.3|131.4|||Regression, Logistic|||||131.4|7.3|<.0001
71788362|NCT03070782|143074457|SUPERIORITY||Odds Ratio (OR)|122.81|||<|0.0001|TWO_SIDED|95.0|24.0|627.4|||Regression, Logistic|||||627.4|24.0|<.0001
71756339|NCT05386329|143016150|SUPERIORITY|Comparison of mid-treatment (week 4) to baseline.|Mean Difference (Final Values)|1.1512|STANDARD_ERROR_OF_MEAN|0.9213|=|0.2225|TWO_SIDED|95.0|-0.7422|3.0446||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT midpoint (week 4) CEQ expectancy scores compared to the baseline (week 0) CEQ expectancy scores.|Null hypothesis: there is no significant difference in treatment expectancy total scores between baseline (week 0) and midpoint (week 4).||3.0446|-0.7422|=.2225
71892203|NCT03464045|143305925|OTHER||Hazard Ratio (HR)|0.91||||0.632|TWO_SIDED|95.0|0.63|1.33|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.33|0.63|0.632
71756340|NCT05386329|143016152|SUPERIORITY|Comparison of post-treatment (week 8) to mid-treatment (week 4)|Wilcoxon Z|0.2712|||=|0.7873|TWO_SIDED|||||The a priori threshold for statistical significance was alpha=.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no significant difference in treatment utilization between midpoint (week 4) and end of treatment (week 8).||||=.7873
71756341|NCT05386329|143016153|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-7.8424|STANDARD_ERROR_OF_MEAN|1.2858|<|0.0001|TWO_SIDED|95.0|-10.4944|-5.1903||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) HAM-D score compared to the baseline (week 0) HAM-D score.|Null hypothesis: there is no significant difference in HAM-D total scores between baseline (week 0) and end of treatment (week 8).||-5.1903|-10.4944|<.0001
71756342|NCT05386329|143016154|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|-9.9409|STANDARD_ERROR_OF_MEAN|1.7329|<|0.0001|TWO_SIDED|95.0|-13.5043|-6.3776||The p-value was not adjusted for multiple comparisons because this was the pre-specified secondary outcome that addresses complementary aspects of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) WSAS scores compared to the baseline (week 0) WSAS scores.|Null hypothesis: there is no significant difference in WSAS total scores between baseline (week 0) and end of treatment (week 8).||-6.3776|-13.5043|<.0001
71756343|NCT05386329|143016155|SUPERIORITY|Pre-post comparison|Mean Difference (Final Values)|21.5463|STANDARD_ERROR_OF_MEAN|3.4152|<|0.0001|TWO_SIDED|95.0|14.512|28.5806||The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary outcome assessing a complementary aspect of the patient experience. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with an unstructured covariance matrix.|The effect is presented as the therapist-guided smartphone-delivered CBT end of treatment (week 8) Q-LES-Q-SF percent scores compared to the baseline (week 0) Q-LES-Q-SF percent scores.|Null hypothesis: there is no significant difference in Q-LES-Q-SF total scores between baseline (week 0) and end of treatment (week 8).||28.5806|14.5120|<.0001
71756344|NCT02667119|143016161|SUPERIORITY||F|4.75||||0.041|TWO_SIDED||||||ANCOVA|Controlled for baseline scores on the National Stressful Events PTSD Scale||Compared the two groups at 3 months post-baseline||||.041
71756345|NCT02667119|143016162|SUPERIORITY||F|6.89||||0.016|TWO_SIDED||||||ANCOVA|Controlled for baseline score on the National Stressful Events PTSD Scale||||||.016
71788363|NCT03070782|143074457|SUPERIORITY||Odds Ratio (OR)|43.78|||<|0.0001|TWO_SIDED|95.0|9.8|195.0|||Regression, Logistic|||||195.0|9.8|<.0001
71671274|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|3.2||||0.4795|TWO_SIDED|95.0|-10.3|16.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||16.6|-10.3|0.4795
71671275|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7||P-value could not be calculated since percentage of participants with events was 0.||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||12.7|-12.7|
71756346|NCT02667119|143016163|SUPERIORITY||t|-2.19||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||.04
71756347|NCT02667119|143016164|SUPERIORITY||F|2.25||||0.148|TWO_SIDED|||||Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale|ANCOVA|||||||.148
71756348|NCT02667119|143016165|SUPERIORITY||F|4.64||||0.043|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Center for Epidemiological Studies-Depressed Mood scale||||||.043
71756349|NCT02667119|143016166|SUPERIORITY||F|1.4||||0.25|TWO_SIDED|||||Controlling for baseline score on the Quality of Life Scale|ANCOVA|||||||.250
71756350|NCT02667119|143016167|SUPERIORITY||F|0.45||||0.508|TWO_SIDED||||||ANCOVA|Controlling for baseline score on the Quality of Life Scale||||||.508
71756351|NCT02059278|143016180|EQUIVALENCE|Analysis at 8 am on Day 15|Mean Difference (Final Values)|0.781||||0.0091|TWO_SIDED|95.0|0.195|1.366|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.366|0.195|0.0091
71788364|NCT03070782|143074457|SUPERIORITY||Odds Ratio (OR)|1124.56|||<|0.0001|TWO_SIDED|95.0|109.3|11571.0|||Regression, Logistic|||||11571|109.3|<.0001
71788365|NCT03070782|143074458|SUPERIORITY||Odds Ratio (OR)|7.34||||0.2007|TWO_SIDED|95.0|0.3|155.3|||Regression, Logistic|||||155.3|0.3|0.2007
71756352|NCT02059278|143016180|EQUIVALENCE|Analysis at 10 am on Day 15|Mean Difference (Final Values)|0.664||||0.0098|TWO_SIDED|95.0|0.161|1.167|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.167|0.161|0.0098
71756353|NCT02059278|143016180|EQUIVALENCE|Analysis at 4 pm on Day 15|Mean Difference (Final Values)|0.542||||0.0398|TWO_SIDED|95.0|0.025|1.058|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.058|0.025|0.0398
71756354|NCT02059278|143016180|EQUIVALENCE|Analysis at 8 am on Day 42|Mean Difference (Final Values)|0.478||||0.1008|TWO_SIDED|95.0|-0.093|1.05|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.050|-0.093|0.1008
71756355|NCT02059278|143016180|EQUIVALENCE|Analysis at 10 am on Day 42|Mean Difference (Final Values)|0.505||||0.0558|TWO_SIDED|95.0|-0.013|1.024|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.024|-0.013|0.0558
71756356|NCT02059278|143016180|EQUIVALENCE|Analysis at 4 pm on Day 42|Mean Difference (Final Values)|0.538||||0.0491|TWO_SIDED|95.0|0.002|1.074|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.074|0.002|0.0491
71756357|NCT02059278|143016180|EQUIVALENCE|Analysis at 8 am on Day 84|Mean Difference (Final Values)|0.808||||0.0025|TWO_SIDED|95.0|0.286|1.329|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.329|0.286|0.0025
71756358|NCT02059278|143016180|EQUIVALENCE|Analysis at 10 am on Day 84|Mean Difference (Final Values)|0.627||||0.0113|TWO_SIDED|95.0|0.143|1.111|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||1.111|0.143|0.0113
71756359|NCT02059278|143016180|EQUIVALENCE|Analysis at 4 pm on Day 84|Mean Difference (Final Values)|0.456||||0.0649|TWO_SIDED|95.0|-0.063|0.975|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.||0.975|-0.063|0.0649
71756360|NCT00737672|143016206|SUPERIORITY_OR_OTHER|||||||0.53|||||||Log Rank|||||||0.530
71756361|NCT00737672|143016209|SUPERIORITY_OR_OTHER|||||||0.475|||||||Log Rank|||||||0.475
71756362|NCT00737672|143016212|SUPERIORITY_OR_OTHER|||||||0.008||||||P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data.|Log Rank|||||||0.008
71756363|NCT00737672|143016213|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test of non-inferior proportions with delta = 0.15.|||||<|0.001|||||||Z-test|One-sided.||||||<0.001
71756364|NCT00737672|143016214|SUPERIORITY_OR_OTHER|||||||0.035|||||||Log Rank|||||||0.035
71756365|NCT00737672|143016217|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|Two-tailed.||||||1.000
71756366|NCT00737672|143016218|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
71756367|NCT00737672|143016219|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|Two-tailed.||||||<0.001
71756368|NCT03818256|143016251|SUPERIORITY||Least Squares Mean Difference|0.11||||0.8511|TWO_SIDED|95.0|-1.03|1.24|||Mixed Models Analysis|||||1.24|-1.03|0.8511
71756369|NCT03818256|143016255|SUPERIORITY||Odds Ratio (OR)|0.82||||0.8169|TWO_SIDED|95.0|0.15|4.474|||Regression, Logistic|||||4.474|0.150|0.8169
71756370|NCT03818256|143016256|SUPERIORITY||Location shift|0.175||||0.9285|TWO_SIDED|95.0|-2.86|2.78|||Wilcoxon rank-sum test|||||2.780|-2.860|0.9285
71671276|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|13.3||||0.1452|TWO_SIDED|95.0|-3.6|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||30.3|-3.6|0.1452
71671277|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
71671278|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|5.8||||0.5707|TWO_SIDED|95.0|-13.7|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-13.7|0.5707
71671279|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|5.8||||0.5777|TWO_SIDED|95.0|-13.6|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-13.6|0.5777
71671280|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|19.3||||0.0744|TWO_SIDED|95.0|1.0|37.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.5|1.0|0.0744
71671281|NCT03349060|142860139|SUPERIORITY||Difference in Percentage|9.7||||0.2232|TWO_SIDED|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.4|-6.1|0.2232
71788366|NCT03070782|143074458|SUPERIORITY||Odds Ratio (OR)|27.92||||0.0258|TWO_SIDED|95.0|1.5|521.5|||Regression, Logistic|||||521.5|1.5|0.0258
71788367|NCT03070782|143074458|SUPERIORITY||Odds Ratio (OR)|113.92||||0.0014|TWO_SIDED|95.0|6.2|2098.5|||Regression, Logistic|||||2098.5|6.2|0.0014
71671282|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|31.6|||<|0.0001|TWO_SIDED|95.0|17.2|46.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.0|17.2|<0.0001
71671283|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|35.7|||<|0.0001|TWO_SIDED|95.0|21.5|49.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||49.9|21.5|<0.0001
71671284|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|20.4||||0.009|TWO_SIDED|95.0|5.2|35.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.6|5.2|0.0090
71671285|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|33.3|||<|0.0001|TWO_SIDED|95.0|19.0|47.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||47.7|19.0|<0.0001
71671286|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|16.5||||0.0421|TWO_SIDED|95.0|0.6|32.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||32.4|0.6|0.0421
71671287|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|33.8|||<|0.0001|TWO_SIDED|95.0|18.9|48.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.8|18.9|<0.0001
71671288|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|23.5||||0.0035|TWO_SIDED|95.0|8.2|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.8|8.2|0.0035
71756371|NCT03818256|143016257|SUPERIORITY||Least squares mean difference|0.007||||0.5669|TWO_SIDED|95.0|-0.018|0.033|||Mixed Models Analysis|||||0.033|-0.018|0.5669
71756372|NCT02121535|143016296|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|101.97|||||TWO_SIDED|90.0|98.94|105.08|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||105.08|98.94|
71756373|NCT02121535|143016297|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|103.77|||||TWO_SIDED|90.0|97.03|110.99|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||110.99|97.03|
71756374|NCT02121535|143016298|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.24|||||TWO_SIDED|90.0|96.8|103.8|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||103.80|96.80|
71892204|NCT03464045|143305926|OTHER||Hazard Ratio (HR)|0.84||||0.42|TWO_SIDED|95.0|0.54|1.29|||Regression, Cox||Crude hazard ratio of empagliflozin/DPP-4i|Crude HRs were calculated using a Cox proportional hazards model with as-treated exposure (continuous exposure to the study drugs, defined as having consecutive treatment episodes separated by a grace period of 30 days, starting from index date) as the only included variable. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.29|0.54|0.420
71892205|NCT03464045|143305926|OTHER||Hazard Ratio (HR)|0.89||||0.606|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Base hazard ratio of empagliflozin/DPP-4i|"Base HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level to avoid converge failure.~Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes."||1.38|0.57|0.606
71671289|NCT03349060|142860140|SUPERIORITY||Difference in Percentage|28.8||||0.0002|TWO_SIDED|95.0|13.8|43.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.9|13.8|0.0002
71671290|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|17.1||||0.2497|TWO_SIDED|95.0|-9.1|43.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.2|-9.1|0.2497
71671291|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|17.1||||0.2371|TWO_SIDED|95.0|-9.0|43.3|||Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||43.3|-9.0|0.2371
71671292|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|28.8||||0.0697|TWO_SIDED|95.0|-0.8|58.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.3|-0.8|0.0697
71788368|NCT03070782|143074458|SUPERIORITY||Odds Ratio (OR)|59.85||||0.0063|TWO_SIDED|95.0|3.2|1128.0|||Regression, Logistic|||||1128.0|3.2|0.0063
71788369|NCT03070782|143074458|SUPERIORITY||Odds Ratio (OR)|347.02|||<|0.0001|TWO_SIDED|95.0|18.3|6597.9|||Regression, Logistic|||||6597.9|18.3|<.0001
71788370|NCT03070782|143074459|SUPERIORITY||Mean Difference in % CFB|-4.0||||0.4022|TWO_SIDED|95.0|-12.0|5.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||5|-12|0.4022
71837348|NCT04927065|143181502|OTHER||GMR|1.637|||||TWO_SIDED|95.0|1.243|2.155|||||SARS-CoV-2 (B.1.1.529) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||2.155|1.243|
71837349|NCT04927065|143181502|OTHER||GMR|1.373|||||TWO_SIDED|95.0|0.953|1.976|||||SARS-CoV-2 (B.1.1.529) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.976|0.953|
71837350|NCT04927065|143181502|OTHER||GMR|1.271|||||TWO_SIDED|95.0|1.051|1.537|||||SARS-CoV-2 (D614G) nAb at Day 181: Part G versus Part F (Cohort 2) mRNA-1273|||1.537|1.051|
71837351|NCT04927065|143181502|OTHER||GMR|1.101|||||TWO_SIDED|95.0|0.83|1.461|||||SARS-CoV-2 (D614G) nAb at Day 366: Part G versus Part F (Cohort 2) mRNA-1273|||1.461|0.830|
71837352|NCT03378570|143181522|OTHER|comparative effectiveness trial||||||0.945|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.945
71837353|NCT03378570|143181523|OTHER|comparative effectiveness trial||||||0.828|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.828
71837354|NCT03378570|143181524|OTHER|comparative effectiveness trial||||||0.252|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||0.252
71892206|NCT03464045|143305926|OTHER||Hazard Ratio (HR)|0.89||||0.609|TWO_SIDED|95.0|0.57|1.38|||Regression, Cox||Adjusted hazard ratio of empagliflozin/DPP-4i|Adjusted HRs were calculated using a Cox proportional hazards model by adjusting for variables unbalanced after PS matching, and pre-specified time-varying covariates. To be included in the Cox model, each covariate is required to have a minimum of 5 events per category level. Country-level HRs were analyzed separately. Thereafter, random-effects meta-analyses were conducted to pool the HRs from all countries, accounting for potential heterogeneity between the country-level effect sizes.||1.38|0.57|0.609
71756375|NCT02121535|143016299|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.42|||||TWO_SIDED|90.0|97.94|100.93|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||100.93|97.94|
71756376|NCT02121535|143016300|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.5|||||TWO_SIDED|90.0|98.08|100.94|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||100.94|98.08|
71788371|NCT03070782|143074459|SUPERIORITY||Mean Difference in % CFB|-16.0|||<|0.0001|TWO_SIDED|95.0|-23.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-23|<.0001
71788372|NCT03070782|143074459|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.0323|TWO_SIDED|95.0|-17.0|-1.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-1|-17|0.0323
71788373|NCT03070782|143074459|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.0157|TWO_SIDED|95.0|-18.0|-2.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-2|-18|0.0157
71788374|NCT03070782|143074459|SUPERIORITY||Mean Difference in % CFB|-17.0|||<|0.0001|TWO_SIDED|95.0|-24.0|-9.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-9|-24|<.0001
71788375|NCT03070782|143074460|SUPERIORITY||Mean Difference in % CFB|-9.0||||0.4956|TWO_SIDED|95.0|-32.0|21.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||21|-32|0.4956
71788376|NCT03070782|143074460|SUPERIORITY||Mean Difference in % CFB|-36.0||||0.0027|TWO_SIDED|95.0|-52.0|-14.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-14|-52|0.0027
71788377|NCT03070782|143074460|SUPERIORITY||Mean Difference in % CFB|-54.0|||<|0.0001|TWO_SIDED|95.0|-65.0|-38.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-38|-65|<.0001
71837355|NCT03378570|143181525|OTHER|||||||0.505||||||p value for response rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.505
71837356|NCT03378570|143181525|OTHER|||||||0.888||||||p value for remission rate|Chi-squared|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.888
71756377|NCT02121535|143016301|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.07|||||TWO_SIDED|90.0|98.45|101.72|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||101.72|98.45|
71788378|NCT03070782|143074460|SUPERIORITY||Mean Difference in % CFB|-31.0||||0.0114|TWO_SIDED|95.0|-48.0|-8.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-8|-48|0.0114
71788379|NCT03070782|143074460|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-49.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-49|-72|<.0001
71788380|NCT03070782|143074461|SUPERIORITY||Mean Difference in % CFB|-45.0||||0.002|TWO_SIDED|95.0|-62.0|-19.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-19|-62|0.0020
71788381|NCT03070782|143074461|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-74.0|-46.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-46|-74|<.0001
71788382|NCT03070782|143074461|SUPERIORITY||Mean Difference in % CFB|-82.0|||<|0.0001|TWO_SIDED|95.0|-87.0|-73.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-73|-87|<.0001
71788383|NCT03070782|143074461|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-78.0|-54.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-78|<.0001
71788384|NCT03070782|143074461|SUPERIORITY||Mean Difference in % CFB|-89.0|||<|0.0001|TWO_SIDED|95.0|-93.0|-84.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-84|-93|<.0001
71788385|NCT00558025|143074482|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: -15 %, power: 80%|Risk Difference (RD)|-10.75||||||95.0|-20.51|1.48|||Wilson score interval|||Successfully switched patients||1.48|-20.51|
71788386|NCT00558025|143074482|SUPERIORITY_OR_OTHER|||||||0.0803||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.0803
71892207|NCT01051739|143306049|SUPERIORITY_OR_OTHER|||||||0.21||||||The a priori threshold of statistical significance is p\<0.05|Kaplan Meyer survival curves|||||||.21
71892208|NCT00707577|143306050|SUPERIORITY||||||<|0.05|||||||Regression, Linear|random effects regression models for panel data adjusted for clustering within team||||||<0.05
71892209|NCT00064701|143306078|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-1.9|||||TWO_SIDED|95.2|-8.9|5.2||||||||5.2|-8.9|
71892210|NCT00064701|143306078|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.0|||||TWO_SIDED|95.2|-9.9|4.0||||||||4.0|-9.9|
71671293|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|43.9||||0.003|TWO_SIDED|95.0|16.2|71.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||71.7|16.2|0.0030
71671294|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|31.0||||0.0583|TWO_SIDED|95.0|2.0|59.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||59.9|2.0|0.0583
71671295|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|41.2||||0.0085|TWO_SIDED|95.0|13.2|69.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||69.1|13.2|0.0085
71671296|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|19.3||||0.1948|TWO_SIDED|95.0|-9.8|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-9.8|0.1948
71756378|NCT02121535|143016302|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|110.16|||||TWO_SIDED|90.0|106.87|113.54|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.||113.54|106.87|
71671297|NCT03349060|142860141|SUPERIORITY||Difference in Percentage|30.6||||0.0296|TWO_SIDED|95.0|2.8|58.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.5|2.8|0.0296
71671298|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.1|0.1718
71671299|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-1.1||||0.0018|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.7|0.0018
71671300|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-1.3||||0.0005|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-2.0|0.0005
71756379|NCT02121535|143016303|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.3|||||TWO_SIDED|90.0|102.53|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.||106.10|102.53|
71756380|NCT02121535|143016304|NON_INFERIORITY_OR_EQUIVALENCE|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.37|||||TWO_SIDED|90.0|102.68|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.||106.10|102.68|
71671301|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.1|-2.5|<0.0001
71788387|NCT00558025|143074483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2061||95.0|-2.8|0.6|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.6|-2.8|0.2061
71788388|NCT00558025|143074484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4694||95.0|-0.8|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-0.8|0.4694
71756381|NCT00091949|143016305|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.0067|TWO_SIDED|95.0|0.62|0.93||P-value adjusted for interim looks.|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for interim looks.|||0.93|0.62|.0067
71756382|NCT00091949|143016306|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.19|TWO_SIDED|95.0|0.61|1.1||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; conference interval (CI) adjusted for multiplicity (5 secondary outcomes).|||1.1|0.61|0.19
71788389|NCT00558025|143074485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.1804||95.0|-2.3|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate||||0.4|-2.3|0.1804
71788390|NCT00558025|143074486|SUPERIORITY_OR_OTHER|||||||0.1623|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1623
71788391|NCT00558025|143074487|SUPERIORITY_OR_OTHER|||||||0.1299|||||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.1299
71788392|NCT00558025|143074488|SUPERIORITY_OR_OTHER|||||||0.619||95.0|||||Cochran-Mantel-Haenszel|test with stratification by country||||||0.6190
71788393|NCT02135146|143074490|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
71788394|NCT02135146|143074490|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71788395|NCT00982592|143074511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.874|TWO_SIDED|95.0|0.7|1.54|||Log Rank|||||1.54|0.70|0.874
71788396|NCT00982592|143074513|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.253|TWO_SIDED|95.0|0.83|2.05|||Log Rank|||||2.05|0.83|0.253
71892211|NCT00064701|143306079|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.3|||||TWO_SIDED|95.0|-7.2|0.6||||||||0.6|-7.2|
71756383|NCT00091949|143016307|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.11|TWO_SIDED|95.0|0.52|1.07||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.07|0.52|0.11
71756384|NCT00091949|143016309|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.52|TWO_SIDED|95.0|0.73|1.17||p-value adjusted for multiplicity (5 secondary outcomes)|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.17|0.73|0.52
71756385|NCT00091949|143016310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.023||||0.88|TWO_SIDED|95.0|-0.326|0.28|||Mixed Models Analysis||Pioglitazone arm compared to placebo.|Changes in modified mini-mental examination (3MS) score from baseline (to annual scores) were analyzed using a longitudinal repeated measures mixed effects model.||0.280|-0.326|0.88
71756386|NCT00091949|143016311|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.11|TWO_SIDED|95.0|0.65|1.05||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).|||1.05|0.65|0.11
71756387|NCT02230995|143016318|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.22|STANDARD_DEVIATION|5.0|<|1e-05|TWO_SIDED|90.0|96.11|100.39|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.39|96.11|<0.00001
71756388|NCT02230995|143016319|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|102.14|STANDARD_DEVIATION|7.9|<|1e-05|TWO_SIDED|90.0|98.65|105.76|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||105.76|98.65|<0.00001
71756389|NCT02230995|143016320|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.7|STANDARD_DEVIATION|12.3|<|1e-05|TWO_SIDED|90.0|93.51|104.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||104.17|93.51|<0.00001
71756390|NCT02230995|143016321|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|105.69|STANDARD_DEVIATION|10.9|<|1e-05|TWO_SIDED|90.0|100.78|110.84|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||110.84|100.78|<0.00001
71756391|NCT02230995|143016322|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|98.32|STANDARD_DEVIATION|5.1|||TWO_SIDED|90.0|96.16|100.53|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||100.53|96.16|
71788397|NCT00333866|143074520|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.23||||0.2361|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.||0.15|-0.61|0.2361
71756392|NCT02230995|143016323|SUPERIORITY_OR_OTHER||Adjusted gMean ratio|104.66|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|101.36|108.07|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).|||108.07|101.36|
71756393|NCT00906204|143016324|NON_INFERIORITY_OR_EQUIVALENCE|A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.||||||0.64|TWO_SIDED||||||Fisher Exact|||The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.||||0.64
71788398|NCT00333866|143074520|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.0132|TWO_SIDED|95.0|-0.94|-0.17|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||-0.17|-0.94|0.0132
71892212|NCT00064701|143306079|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||||3.2|-3.1|
71892213|NCT00064701|143306080|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.8|||||TWO_SIDED|95.0|-8.5|0.9||||||||0.9|-8.5|
71671302|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-0.7||||0.0476|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.5|0.0476
71671303|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.0|-2.4|<0.0001
71892214|NCT00064701|143306080|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||TWO_SIDED|95.0|-4.0|4.1||||||||4.1|-4.0|
71892215|NCT00064701|143306081|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-8.0|||||TWO_SIDED|95.0|-13.1|-3.0||||||Comparison of tacrolimus with cyclosporine at 6 months||-3.0|-13.1|
71756394|NCT00906204|143016325|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Log Rank|||||||0.35
71756395|NCT00906204|143016326|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Log Rank|||||||0.47
71756396|NCT00906204|143016327|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Log Rank|||||||0.78
71756397|NCT00906204|143016328|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Fisher Exact|||||||0.72
71756398|NCT00906204|143016329|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
71892216|NCT00064701|143306081|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-3.8|||||TWO_SIDED|95.0|-9.5|1.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 6 months||1.8|-9.5|
71892217|NCT00064701|143306081|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 Months|-6.1|||||TWO_SIDED|95.0|-12.0|-0.3||||||Comparison of tacrolimus with cyclosporine at 12 months||-0.3|-12.0|
71892218|NCT00064701|143306081|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 months|-3.4|||||TWO_SIDED|95.0|-9.6|2.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 12 months||2.8|-9.6|
71892219|NCT00064701|143306091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-6.5|5.5||||||||5.5|-6.5|
71892220|NCT00064701|143306091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-3.9|6.9||||||||6.9|-3.9|
71892221|NCT00064701|143306092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-9.1|6.6||||||||6.6|-9.1|
71892222|NCT00064701|143306092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-7.1|8.6||||||||8.6|-7.1|
71892223|NCT02249052|143306093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|STANDARD_DEVIATION|25.0311|<|0.0001|TWO_SIDED|95.0|-95.394|-71.265|||t-test, 2 sided|||||-71.265|-95.394|<0.0001
71892224|NCT02249052|143306094|SUPERIORITY_OR_OTHER||Binomial proportion|0.8947|||<|0.0001|TWO_SIDED|95.0|0.6686|0.987|||Sign test|||||.9870|.6686|<.0001
71892225|NCT04898166|143306121|SUPERIORITY|||||||0|||||||Chi-squared|Chi-square value 18.90 and its asymptotic significance .000||||||0.000
71892226|NCT04898166|143306122|SUPERIORITY|||||||0.081|||||||Chi-squared|Chi-square value 7.544 and its asymptotic significance .273||||||0.081
71892227|NCT05202808|143306239|NON_INFERIORITY|"The endothelial cell loss (ECL) at 6 months was compared between the LAL and Control groups. The statistical hypothesis is:~* H0: Median(LAL) - Median(control) ≥ 5% vs~* Ha: Median(LAL) - Median(control) \< 5%~The median ECL for the LAL group is at most 5% higher than the median ECL for the Control group.~The first co-primary safety endpoint is met if the median ECL of the LAL group is non-inferior to the Control group using a right-tail Wilcoxon test using a significance level of 0.05."|Median Difference (Final Values)|0.2|||<|0.0001|TWO_SIDED|90.0|-1.0|1.66|||Wilcoxon (Mann-Whitney)|||With a one-sided significance level of 0.05, a power of 0.80, a randomization ratio of 2:1, and then the Mann-Whitney-Wilcoxon asymptotic relative efficiency (A.R.E.) efficiency adjustment, the sample size per two-sample t-test is 192 LAL eyes and 96 Control eyes (total of 288), with an assumed dropout rate of 10%.||1.66|-1.00|<0.0001
71892228|NCT05202808|143306241|OTHER||Odds Ratio (OR)|4.61|||||TWO_SIDED|95.0|2.97|7.15|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and Control group is the denominator. At Month 6, the odds of achieving UCDVA of 20/20 or better were 4.61 times greater for the LAL group than the Control group.|||7.15|2.97|
71892229|NCT05202808|143306242|OTHER||Odds Ratio (OR)|20.74|||||TWO_SIDED|95.0|12.05|36.14|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving Absolute MRCYL of 0.5D or less was 20.74 for the LAL group versus the Control group at month 6.|||36.14|12.05|
71892230|NCT05202808|143306243|OTHER||Odds Ratio (OR)|14.46|||||TWO_SIDED|95.0|8.89|23.57|||||Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving simultaneous Absolute MRSE and MRCL of 0.5 D or less was 14.46 in the LAL group vs. Control at month 6.|||23.57|8.89|
71892231|NCT02747004|143306247|SUPERIORITY|||||||0.293||||||Two-sided P-value.|Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||||0.2930
71892232|NCT02747004|143306247|OTHER|Informal phase 2 non-inferiority.|Hazard Ratio (HR)|1.045|||||TWO_SIDED|95.0|0.711|1.535|||Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.||||1.535|0.711|
71892233|NCT05087030|143306259|NON_INFERIORITY|The analysis was performed with an ANCOVA model with %CfB in lumbar spine BMD at Week 52 as the dependent variable, covariates were treatment arm (RGB-14-P and US-licensed Prolia).|Estimated Difference|0.18|||||TWO_SIDED|90.0|-0.465|0.826|||ANCOVA|||||0.826|-0.465|
71892234|NCT05087030|143306259|SUPERIORITY|Non-Superiority Test|Estimated Difference|0.55|||||TWO_SIDED|90.0|-0.099|1.191|||ANCOVA|||||1.191|-0.099|
71892235|NCT05087030|143306260|OTHER||Geometric mean ratio|1.01||||0.494|TWO_SIDED|95.0|0.978|1.046|||ANCOVA|||Comparison between Study Treatment Groups||1.046|0.978|0.494
71892236|NCT05087030|143306261|OTHER||Estimated difference|-0.31||||0.199|TWO_SIDED|95.0|-0.792|0.165|||Mixed model repeated measures|||at Week 26||0.165|-0.792|0.199
71671304|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-1.1||||0.0028|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.4|-1.9|0.0028
71671305|NCT03349060|142860142|SUPERIORITY||Difference in LS mean|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-2.3|<0.0001
71671306|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-0.2||||0.6134|TWO_SIDED|95.0|-0.9|0.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.5|-0.9|0.6134
71671307|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-0.7||||0.0422|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.0|-1.4|0.0422
71671308|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-0.5||||0.205|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2050
71671309|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-1.2||||0.0012|TWO_SIDED|95.0|-1.9|-0.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-1.9|0.0012
71788399|NCT00333866|143074520|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-0.33||||0.1694|TWO_SIDED|95.0|-0.72|0.05|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.||0.05|-0.72|0.1694
71671310|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-0.4||||0.2657|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.3|-1.2|0.2657
71671311|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-1.2||||0.0019|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.5|-2.0|0.0019
71671312|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-0.5||||0.1675|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.2|-1.3|0.1675
71671313|NCT03349060|142860143|SUPERIORITY||Difference in LS mean|-1.0||||0.0085|TWO_SIDED|95.0|-1.8|-0.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.3|-1.8|0.0085
71671314|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|8.8||||0.5539|TWO_SIDED|95.0|-19.6|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||37.2|-19.6|0.5539
71671315|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|27.9||||0.0561|TWO_SIDED|95.0|0.8|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|0.8|0.0561
71671316|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|-4.9||||0.746|TWO_SIDED|95.0|-33.4|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-33.4|0.7460
71671317|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|0.0||||1|TWO_SIDED|95.0|-28.3|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||28.3|-28.3|1.0000
71671318|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|20.8||||0.1474|TWO_SIDED|95.0|-4.5|46.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||46.2|-4.5|0.1474
71671319|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|37.3||||0.0123|TWO_SIDED|95.0|12.1|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||62.5|12.1|0.0123
71671320|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|-0.4||||0.976|TWO_SIDED|95.0|-28.5|27.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.6|-28.5|0.9760
71788400|NCT00333866|143074521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0227
71788401|NCT00333866|143074521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0017
71788402|NCT00333866|143074521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0768||95.0|||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.||||0.0768
71788403|NCT00333866|143074522|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|||<|0.0001|TWO_SIDED|95.0|-1.42|-0.6|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.60|-1.42|<.0001
71788404|NCT00333866|143074522|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78||||0.0002|TWO_SIDED|95.0|-1.2|-0.37|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.37|-1.20|0.0002
71788405|NCT00333866|143074522|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48||||0.0222|TWO_SIDED|95.0|-0.89|-0.07|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.||-0.07|-0.89|0.0222
71788406|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
71788407|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
71788408|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
71788409|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
71788410|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
71788411|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
71788412|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.5|<.0001
71788413|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
71788414|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67||||0.0005|TWO_SIDED|95.0|-1.0|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.0|0.0005
71788415|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.28|||<|0.0001||95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
71788416|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.3|<.0001
71788417|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
71756399|NCT02141295|143016360|OTHER||Hazard Ratio (HR)|0.91|||=|0.6753|TWO_SIDED|95.0|0.6|1.39||log-rank|Regression, Cox|||Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.39|0.60|= 0.6753
71837357|NCT03378570|143181526|OTHER|||||||0.994|||||||Chi-squared|p value for response rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.994
71892237|NCT05087030|143306261|OTHER||Estimated difference|-0.16||||0.543|TWO_SIDED|95.0|-0.68|0.358|||mixed model repeated measures|||At Week 52||0.358|-0.680|0.543
71671321|NCT03349060|142860144|SUPERIORITY||Difference in Percentage|7.8||||0.5965|TWO_SIDED|95.0|-20.4|36.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.1|-20.4|0.5965
71756400|NCT02141295|143016363|OTHER||Hazard Ratio (HR)|0.85|||=|0.574|TWO_SIDED|95.0|0.49|1.49|||Log Rank|||Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. \>1) and country/region (USA vs rest of the world).||1.49|0.49|= 0.5740
71756401|NCT00071890|143016385|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Chi-squared|||||||0.025
71756402|NCT00071890|143016386|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups|Wilcoxon (Mann-Whitney)|||||||0.069
71756403|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||MI at 0-6 Months||||>0.999
71756404|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-12 Months||||0.4889
71756405|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.4889|||||||Fisher Exact|||MI at 0-18 Months||||0.4889
71756406|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-6 Months||||>0.999
71756407|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-12 Months||||>0.999
71756408|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Stroke at 0-18 Months||||>0.999
71756409|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.7381|||||||Fisher Exact|||Major amputation at 0-6 Months||||0.7381
71756410|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-12 Months||||>0.999
71756411|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-18 Months||||>0.999
71756412|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||Revascularization at 0-6 Months||||>0.999
71756413|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-12 Months||||0.4591
71756414|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.4591|||||||Fisher Exact|||Revascularization at 0-18 Months||||0.4591
71756415|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-6 Months||||>0.999
71756416|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-12 Months||||>0.999
71756417|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-18 Months||||>0.999
71756418|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.5136|||||||Fisher Exact|||0-6 Months (Major Amputation or Death)||||0.5136
71756419|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-12 Months (Major Amputation or Death)||||0.7575
71756420|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Death)||||>0.999
71756421|NCT02144610|143016397|SUPERIORITY_OR_OTHER|||||||0.7575|||||||Fisher Exact|||0-6 Months (Major Amputation or Revascularization)||||0.7575
71756422|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-12 Months (Major Amputation or Revascularization)||||>0.999
71756423|NCT02144610|143016397|SUPERIORITY_OR_OTHER||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Revascularization)||||>0.999
71756424|NCT02144610|143016398|SUPERIORITY_OR_OTHER|||||||0.514|||||||ANCOVA|||Change from Baseline at Month 3||||0.514
71756425|NCT02144610|143016398|SUPERIORITY_OR_OTHER|||||||0.445|||||||ANCOVA|||Change from Baseline at Month 6||||0.445
71756426|NCT02144610|143016398|SUPERIORITY_OR_OTHER|||||||0.863|||||||ANCOVA|||Change from Baseline at Month 9||||0.863
71756427|NCT02144610|143016398|SUPERIORITY_OR_OTHER|||||||0.111|||||||ANCOVA|||Change from Baseline at Month 12||||0.111
71756428|NCT02144610|143016398|SUPERIORITY_OR_OTHER|||||||0.153|||||||ANCOVA|||Change from Baseline at Month 15||||0.153
71756429|NCT02144610|143016398|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||Change from Baseline at last observation carried forward (LOCF)||||0.002
71756430|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.733|||||||ANCOVA|||Change from baseline at Month 3 (right brachial)||||0.733
71756431|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.808|||||||ANCOVA|||Change from baseline at Month 6 (right brachial)||||0.808
71756432|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.487|||||||ANCOVA|||Change from baseline at Month 9 (right brachial)||||0.487
71756433|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.216|||||||ANCOVA|||Change from baseline at Month 12 (right brachial)||||0.216
71756434|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|||Change from baseline at Month 15 (right brachial)||||0.896
71756435|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.167|||||||ANCOVA|||Change from baseline at last observation carried forward (LOCF) (right brachial)||||0.167
71756436|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.378|||||||ANCOVA|||Change from baseline at Month 3 (left brachial)||||0.378
71788418|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
71788419|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
71788420|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.2|<.0001
71788421|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
71788422|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
71788423|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72||||0.0003|TWO_SIDED|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.1|0.0003
71788424|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
71788425|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
71788426|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0037|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0037
71788427|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.7|<.0001
71788428|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.4|<.0001
71788429|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0031|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0031
71788430|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.5|<.0001
71788431|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
71892238|NCT05087030|143306262|OTHER||Estimated Difference|0.03||||0.929|TWO_SIDED|95.0|-0.703|0.769|||mixed model for repeated measures|||Week 26||0.769|-0.703|0.929
71892239|NCT01444300|143306272|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.51
71892240|NCT01444300|143306273|SUPERIORITY_OR_OTHER|||||||0.7|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo after 12 weeks.||||0.7
71892241|NCT01444300|143306274|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo||||0.8
71892242|NCT02370121|143306292|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71892243|NCT02370121|143306293|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71892244|NCT02370121|143306294|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71892245|NCT02370121|143306295|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71892246|NCT02370121|143306296|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71892247|NCT02370121|143306297|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71892248|NCT02370121|143306298|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71671322|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|24.0||||0.2278|TWO_SIDED|95.0|-9.9|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||58.0|-9.9|0.2278
71671323|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|35.2||||0.0996|TWO_SIDED|95.0|-2.0|72.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||72.4|-2.0|0.0996
71671324|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|14.5||||0.4449|TWO_SIDED|95.0|-21.6|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||50.6|-21.6|0.4449
71671325|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|16.9||||0.4139|TWO_SIDED|95.0|-21.6|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.5|-21.6|0.4139
71671326|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|-6.7||||0.729|TWO_SIDED|95.0|-40.7|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.4|-40.7|0.7290
71756437|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.39|||||||ANCOVA|||Change from baseline at Month 6 (left brachial)||||0.390
71756438|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.521|||||||ANCOVA|||Change from baseline at Month 9 (left brachial)||||0.521
71756439|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|||Change from baseline at Month 12 (left brachial)||||0.044
71756440|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.423|||||||ANCOVA|||Change from baseline at Month 15 (left brachial)||||0.423
71756441|NCT02144610|143016401|SUPERIORITY_OR_OTHER|||||||0.989|||||||ANCOVA|||Change from baseline at LOCF (left brachial)||||0.989
71756442|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.803|||||||ANCOVA|||Change from Baseline at Month 3 (Dorsalis Pedis)||||0.803
71756443|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.668|||||||ANCOVA|||Change from Baseline at Month 6 (Dorsalis Pedis)||||0.668
71788432|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.0117|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-0.9|0.0117
71756444|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.789|||||||ANCOVA|||Change from Baseline at Month 9 (Dorsalis Pedis)||||0.789
71756445|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|||Change from Baseline at Month 12 (Dorsalis Pedis)||||0.280
71756446|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.324|||||||ANCOVA|||Change from Baseline at LOCF (Dorsalis Pedis)||||0.324
71756447|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||Change from Baseline at Month 3 (Posterior Tibial)||||0.759
71756448|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.414|||||||ANCOVA|||Change from Baseline at Month 6 (Posterior Tibial)||||0.414
71756449|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.886|||||||ANCOVA|||Change from Baseline at Month 9 (Posterior Tibial)||||0.886
71756450|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.114|||||||ANCOVA|||Change from Baseline at Month 12 (Posterior Tibial)||||0.114
71756451|NCT02144610|143016402|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Change from Baseline at LOCF (Posterior Tibial)||||0.051
71756452|NCT02144610|143016403|SUPERIORITY_OR_OTHER|||||||0.211|||||||ANCOVA|||Change from Baseline at Month 3||||0.211
71756453|NCT02144610|143016403|SUPERIORITY_OR_OTHER|||||||0.036|||||||ANCOVA|||Change from Baseline at Month 6||||0.036
71756454|NCT02144610|143016403|SUPERIORITY_OR_OTHER|||||||0.725|||||||ANCOVA|||Change from Baseline at Month 9||||0.725
71756455|NCT02144610|143016403|SUPERIORITY_OR_OTHER|||||||0.468|||||||ANCOVA|||Change from Baseline at Month 12||||0.468
71756456|NCT02144610|143016403|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANCOVA|||Change from Baseline at Month 15||||0.854
71756457|NCT02144610|143016403|SUPERIORITY_OR_OTHER|||||||0.233|||||||ANCOVA|||Change from Baseline at LOCF||||0.233
71756458|NCT02144610|143016404|SUPERIORITY_OR_OTHER|||||||0.268|||||||ANCOVA|||Change from Baseline at Month 3||||0.268
71756459|NCT02144610|143016404|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANCOVA|||Change from Baseline at Month 6||||0.320
71756460|NCT02144610|143016404|SUPERIORITY_OR_OTHER|||||||0.315|||||||ANCOVA|||Change from Baseline at Month 9||||0.315
71756461|NCT02144610|143016404|SUPERIORITY_OR_OTHER|||||||0.327|||||||ANCOVA|||Change from Baseline at Month 12||||0.327
71756462|NCT02144610|143016404|SUPERIORITY_OR_OTHER|||||||0.643|||||||ANCOVA|||Change from Baseline at Month 15||||0.643
71756463|NCT02144610|143016404|SUPERIORITY_OR_OTHER|||||||0.74|||||||ANCOVA|||Change from Baseline at LOCF||||0.740
71756464|NCT02144610|143016405|SUPERIORITY_OR_OTHER|||||||0.147|||||||ANCOVA|||Change from Baseline at Month 3||||0.147
71756465|NCT02144610|143016405|SUPERIORITY_OR_OTHER|||||||0.032|||||||ANCOVA|||Change from Baseline at Month 6||||0.032
71756466|NCT02144610|143016405|SUPERIORITY_OR_OTHER|||||||0.709|||||||ANCOVA|||Change from Baseline at Month 9||||0.709
71756467|NCT02144610|143016405|SUPERIORITY_OR_OTHER|||||||0.771|||||||ANCOVA|||Change from Baseline at Month 12||||0.771
71756468|NCT02144610|143016405|SUPERIORITY_OR_OTHER|||||||0.83|||||||ANCOVA|||Change from Baseline at Month 15||||0.830
71756469|NCT02144610|143016405|SUPERIORITY_OR_OTHER|||||||0.033|||||||ANCOVA|||Change from Baseline at LOCF||||0.033
71756470|NCT02144610|143016406|SUPERIORITY_OR_OTHER|||||||0.105|||||||ANCOVA|||Pain (LOCF)||||0.105
71756471|NCT02144610|143016406|SUPERIORITY_OR_OTHER|||||||0.557|||||||ANCOVA|||Symptom (LOCF)||||0.557
71756472|NCT02144610|143016406|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||Activities (LOCF)||||0.940
71756473|NCT02144610|143016406|SUPERIORITY_OR_OTHER|||||||0.905|||||||ANCOVA|||Social (LOCF)||||0.905
71671327|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|8.7||||0.6585|TWO_SIDED|95.0|-27.3|44.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.6|-27.3|0.6585
71671328|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|18.2||||0.3638|TWO_SIDED|95.0|-18.7|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||55.1|-18.7|0.3638
71756474|NCT02144610|143016406|SUPERIORITY_OR_OTHER|||||||0.782|||||||ANCOVA|||Emotional Functioning (LOCF)||||0.782
71756475|NCT02144610|143016406|SUPERIORITY_OR_OTHER|||||||0.802|||||||ANCOVA|||Composite Overall (LOCF)||||0.802
71756476|NCT02144610|143016407|SUPERIORITY_OR_OTHER|||||||0.941|||||||ANCOVA|||Change from Baseline at Month 3||||0.941
71788433|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
71788434|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
71788435|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0040
71788436|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.7|-1.6|<.0001
71788437|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.2|<.0001
71788438|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.01|TWO_SIDED|95.0|-1.0|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.1|-1.0|0.0100
71788439|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.5|<.0001
71788440|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.0006|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.3|-1.2|0.0006
71756477|NCT02144610|143016407|SUPERIORITY_OR_OTHER|||||||0.584|||||||ANCOVA|||Change from Baseline at Month 6||||0.584
71756478|NCT02144610|143016407|SUPERIORITY_OR_OTHER|||||||0.1|||||||ANCOVA|||Change from Baseline at Month 9||||0.100
71756479|NCT02144610|143016407|SUPERIORITY_OR_OTHER|||||||0.916|||||||ANCOVA|||Change from Baseline at Month 12||||0.916
71756480|NCT02144610|143016407|SUPERIORITY_OR_OTHER|||||||0.486|||||||ANCOVA|||Change from Baseline at Month 15||||0.486
71756481|NCT02144610|143016407|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANCOVA|||Change from Baseline at LOCF||||0.835
71756482|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.046||||0.085|TWO_SIDED|95.0|-0.006|0.098|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.098|-0.006|0.085
71756483|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.123|TWO_SIDED|95.0|-0.011|0.093|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.093|-0.011|0.123
71756484|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.185|||<|0.001|TWO_SIDED|95.0|0.133|0.237|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.237|0.133|<0.001
71756485|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.214|||<|0.001|TWO_SIDED|95.0|0.161|0.266||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.266|0.161|<0.001
71756486|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.209|||<|0.001|TWO_SIDED|95.0|0.157|0.261|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.261|0.157|<0.001
71756487|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.116|0.22||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.220|0.116|<0.001
71756488|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.168|||<|0.001|TWO_SIDED|95.0|0.117|0.219|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.219|0.117|<0.001
71756489|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.274|TWO_SIDED|95.0|-0.023|0.081|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.081|-0.023|0.274
71892249|NCT02370121|143306299|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71671329|NCT03349060|142860145|SUPERIORITY||Difference in Percentage|40.5||||0.055|TWO_SIDED|95.0|2.4|78.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||78.5|2.4|0.0550
71756490|NCT01054885|143016409|SUPERIORITY_OR_OTHER||Least squares mean difference|0.024||||0.357|TWO_SIDED|95.0|-0.027|0.075|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.075|-0.027|0.357
71756491|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.044||||0.095|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.095
71756492|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.008||||0.756|TWO_SIDED|95.0|-0.044|0.06|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.060|-0.044|0.756
71756493|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.048|0.151|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.151|0.048|<0.001
71756494|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.144|||<|0.001|TWO_SIDED|95.0|0.091|0.197||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.197|0.091|<0.001
71788441|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||0.0|-0.8|0.0690
71892250|NCT02370121|143306300|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71671330|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
71756495|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.131|||<|0.001|TWO_SIDED|95.0|0.08|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.183|0.080|<0.001
71892251|NCT02370121|143306301|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71756496|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.1|||<|0.001|TWO_SIDED|95.0|0.047|0.152||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.152|0.047|<0.001
71756497|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.123|||<|0.001|TWO_SIDED|95.0|0.072|0.174||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.174|0.072|<0.001
71756498|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.045||||0.093|TWO_SIDED|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.097|-0.008|0.093
71756499|NCT01054885|143016410|SUPERIORITY_OR_OTHER||Least squares mean difference|0.032||||0.224|TWO_SIDED|95.0|-0.019|0.083|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.083|-0.019|0.224
71756500|NCT01399372|143016420|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.015|TWO_SIDED|95.0|0.27|0.95||One-sided significance level = 0.15|Log Rank||Reference arm = Chemotherapy|Sample size of 89 provided 80% power to detect a hazard ratio of 0.63 at a one-sided alpha level of 0.15.||0.95|0.27|0.015
71756501|NCT01399372|143016421|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.48|TWO_SIDED|95.0|0.38|1.58||Two-sided significance level = 0.05|Log Rank||Reference arm = Chemotherapy|||1.58|0.38|0.48
71756502|NCT01399372|143016423|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||A mixed effects model of EORTC QLQ-C30 GHS was run with independent variables treatment arm, time, baseline Memorial Sloan-Kettering Cancer Center (MSKCC) recursive partitioning analysis (RPA) class, and baseline neurologic symptoms (none/minor vs. moderate/severe), including the interaction of treatment and time, representing difference in the longitudinal trajectory of the scores between the treatment arms. Prospectively, the interaction effect was of most interest and is reported here,||||0.005
71892252|NCT02370121|143306302|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71892253|NCT02370121|143306303|SUPERIORITY_OR_OTHER|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71892254|NCT02370121|143306304|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71892255|NCT02370121|143306305|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71892256|NCT02370121|143306306|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71892257|NCT02370121|143306307|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71671331|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|-35.3||||0.158|TWO_SIDED|95.0|-75.9|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||5.3|-75.9|0.1580
71671332|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|-14.2||||0.514|TWO_SIDED|95.0|-53.5|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.1|-53.5|0.5140
71756503|NCT01399372|143016424|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.18|TWO_SIDED|95.0|0.21|1.31|||Gray's test||Reference arm = Chemotherapy arm|||1.31|0.21|0.18
71756504|NCT01432730|143016426|SUPERIORITY||Log mean difference (Active - Placebo)|-0.6027||||0.0003|TWO_SIDED|95.0|-0.9049|-0.3005|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.3005|-0.9049|0.0003
71837358|NCT03378570|143181526|OTHER|||||||0.911|||||||Chi-squared|p value for remission rates||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.911
71837359|NCT03378570|143181527|OTHER|||||||0.778|||||||t-test, 2 sided|||"The null hypothesis of this study was that there would be no differences between targets across all measures.~A power analysis revealed that a total sample size of 144 would have 80% power when testing for differences between target groups at alpha = 0.05. Accounting for potential attrition, the study conservatively planned to enroll 200 participants, with a planned interim analysis after 100 participants were randomized."||||0.778
71756505|NCT01432730|143016427|SUPERIORITY||Mean Difference (Final Values)|-25.57||||0.003|TWO_SIDED|95.0|-41.53|-9.62|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-9.62|-41.53|0.003
71756506|NCT01432730|143016428|SUPERIORITY||Log mean difference (Active - Placebo)|-0.4212||||0.057|TWO_SIDED|95.0|-0.8568|0.01438|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||0.01438|-0.8568|0.057
71756507|NCT01432730|143016429|SUPERIORITY||Mean Difference (Final Values)|-8.53||||0.172|TWO_SIDED|95.0|-20.93|3.87|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||3.87|-20.93|0.172
71756508|NCT01432730|143016430|SUPERIORITY||Log mean difference (Active - Placebo)|-0.582||||0.001|TWO_SIDED|95.0|-0.8934|-0.2707|||Mixed Models Analysis|Mixed model included terms for treatment sequence, participant within sequence, treatment \& period. Average \& period baseline covariates included.||||-0.2707|-0.8934|0.001
71756509|NCT01432730|143016431|SUPERIORITY||Mean Difference (Final Values)|-2.538||||0.033|TWO_SIDED|95.0|-4.849|-0.227|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.227|-4.849|0.033
71788442|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
71788443|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.5|-1.3|<.0001
71671333|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|-19.8||||0.4149|TWO_SIDED|95.0|-63.3|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.7|-63.3|0.4149
71671334|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|-18.8||||0.4036|TWO_SIDED|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||20.9|-58.4|0.4036
71756510|NCT01432730|143016432|SUPERIORITY||Median Difference (Final Values)|-2.267||||0.049|TWO_SIDED|95.0|-4.523|-0.01|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-0.010|-4.523|0.049
71788444|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.0|0.0054
71788445|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.8|-1.6|<.0001
71756511|NCT01432730|143016433|SUPERIORITY||Mean Difference (Final Values)|-9.237||||0.018|TWO_SIDED|95.0|-16.759|-1.716|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.716|-16.759|0.018
71671335|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|-30.7||||0.2092|TWO_SIDED|95.0|-70.9|9.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||9.6|-70.9|0.2092
71756512|NCT01432730|143016434|SUPERIORITY||Mean Difference (Final Values)|-21.25||||0.035|TWO_SIDED|95.0|-40.96|-1.54|||Mixed Models Analysis|Mixed effect model fitting terms for treatment sequence, participant within sequence, treatment, and period.||||-1.54|-40.96|0.035
71756513|NCT03881852|143016449|SUPERIORITY||||||<|0.001||||||P-value calculated from LSMean|Mixed Models Analysis|||||||<0.001
71756514|NCT01421719|143016450|SUPERIORITY_OR_OTHER|||||||0.0087||95.0|||||t-test, 2 sided|||Paired t test comparison of baseline number of urinary leaks per day versus number of leaks per day at 6 month evaluation after treatment.||||0.0087
71756515|NCT01298648|143016472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed cases at Baseline and Week 4.||||||<0.0001
71756516|NCT01298648|143016474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|Paired t-test using observed values at Baseline and Week 8.||||||<0.0001
71756517|NCT01298648|143016475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed values at Baseline and Week 24.||||||<0.0001
71756518|NCT04226742|143016526|SUPERIORITY||Mean Difference (Net)|0.58||||0.79|TWO_SIDED|95.0|-3.71|4.88||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.88|-3.71|0.79
71756519|NCT04226742|143016527|SUPERIORITY||Mean Difference (Net)|0.9||||0.61|TWO_SIDED|95.0|-2.52|4.32||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||4.32|-2.52|.61
71756520|NCT04226742|143016528|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.088|TWO_SIDED|95.0|-0.05|0.68||Significance threshold of alpha = 0.05|Mixed Models Analysis|||||0.68|-0.05|0.088
71756521|NCT04226742|143016529|SUPERIORITY||Mean Difference (Final Values)|13.68||||0.142|TWO_SIDED|95.0|-4.62|31.99||Threshold for statistical significance of alpha = 0.05|Mixed Models Analysis|||||31.99|-4.62|0.142
71756522|NCT04226742|143016530|SUPERIORITY||Mean Difference (Final Values)|-6.87||||0.109|TWO_SIDED|95.0|-15.28|1.54||Threshold for statistical significance of alpha = .05|Mixed Models Analysis|||||1.54|-15.28|0.109
71788446|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.3|<.0001
71788447|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65||||0.0036|TWO_SIDED|95.0|-1.1|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.2|-1.1|0.0036
71788448|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.16|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.9|-1.5|<.0001
71788449|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.6|-1.1|<.0001
71788450|NCT00333866|143074523|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.||-0.4|-1.0|<.0001
71788451|NCT00333866|143074524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.537|TWO_SIDED|95.0|0.71|1.95|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.95|0.71|0.5370
71788452|NCT00333866|143074524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.92||||0.0109|TWO_SIDED|95.0|1.16|3.18|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||3.18|1.16|0.0109
71788453|NCT00333866|143074524|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.9613|TWO_SIDED|95.0|0.61|1.68|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.||1.68|0.61|0.9613
71788454|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.71|||<|0.0001|TWO_SIDED|95.0|-17.56|-7.86|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-7.86|-17.56|<.0001
71756523|NCT04226742|143016531|SUPERIORITY||Mean Difference (Final Values)|-1.01||||0.736|TWO_SIDED|95.0|-6.92|4.89|||Mixed Models Analysis|||||4.89|-6.92|0.736
71756524|NCT02606643|143016562|SUPERIORITY_OR_OTHER|||||||0.814|||||||Chi-squared|||an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group||||0.814
71756525|NCT00912808|143016571|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.049
71892258|NCT02370121|143306308|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71892259|NCT01587989|143306314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327||||0.188|TWO_SIDED|95.0|-0.165|0.82|||t-test, 2 sided|||||0.820|-0.165|0.188
71892260|NCT01587989|143306314|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANCOVA|||At Week 12.||||0.015
71671336|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|11.9||||0.5982|TWO_SIDED|95.0|-29.1|53.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||53.0|-29.1|0.5982
71756526|NCT00912808|143016572|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.||||0.27
71671337|NCT03349060|142860146|SUPERIORITY||Difference in Percentage|4.2||||0.8647|TWO_SIDED|95.0|-36.3|44.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||44.7|-36.3|0.8647
71671338|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|-78.6||||0.0546|TWO_SIDED|95.0|-117.5|-39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||-39.6|-117.5|0.0546
71671339|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|-27.9||||0.3573|TWO_SIDED|95.0|-62.5|6.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||6.7|-62.5|0.3573
71671340|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|-3.6||||0.9219|TWO_SIDED|95.0|-55.6|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||48.5|-55.6|0.9219
71756527|NCT03873116|143016573|SUPERIORITY||negative binomial regression model|-24.6||||0.181|TWO_SIDED|95.0|-50.1|14.0|||negative binomial regression model|||||14.0|-50.1|0.181
71756528|NCT03873116|143016573|SUPERIORITY||negative binomial regression model|-49.1||||0.003|TWO_SIDED|95.0|-67.5|-20.4|||negative binomial regression model|||||-20.4|-67.5|0.003
71756529|NCT03873116|143016576|SUPERIORITY||Difference in Least Square Means|0.018||||0.814|TWO_SIDED|95.0|-0.143|0.179|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.179|-0.143|0.814
71756530|NCT03873116|143016576|SUPERIORITY||Difference in Least Square Means|-0.122||||0.12|TWO_SIDED|95.0|-0.28|0.036|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms.||0.036|-0.280|0.120
71756531|NCT03873116|143016577|SUPERIORITY||mixed-model repeated measures analysis|24.5||||0.188|TWO_SIDED|95.0|-14.7|50.3|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||50.3|-14.7|0.188
71756532|NCT03873116|143016577|SUPERIORITY||mixed-model repeated measures analysis|47.6||||0.005|TWO_SIDED|95.0|17.7|66.6|||mixed-model repeated measures analysis|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of rate of expert-confirmed angioedema events during dosing in the effective treatment period for statistical significance would not be completed. Therefore, P-values reported are nominal.||66.6|17.7|0.005
71756533|NCT03873116|143016578|SUPERIORITY||mixed-model repeated measures analysis|-12.65||||0.213|TWO_SIDED|95.0|-33.33|8.03|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||8.03|-33.33|0.213
71756534|NCT03873116|143016578|SUPERIORITY||mixed-model repeated measures analysis|-19.0||||0.061|TWO_SIDED|95.0|-39.0|0.99|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of change from baseline in AE-QoL total score at Week 24 for statistical significance would not be completed. P-values that are reported are nominal.||0.99|-39.00|0.061
71756535|NCT03755934|143016624|SUPERIORITY||LS mean estimate|-1.96|STANDARD_ERROR_OF_MEAN|0.961||0.0437|TWO_SIDED|95.0|-3.87|-0.06||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.06|-3.87|0.0437
71756536|NCT03755934|143016624|SUPERIORITY||LS mean estimate|0.72|STANDARD_ERROR_OF_MEAN|0.541||0.1878|TWO_SIDED|95.0|-0.36|1.79||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||1.79|-0.36|0.1878
71837360|NCT03378570|143181528|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures.||||.951
71837361|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.278|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Positive Affect.||||.278
71837362|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.024|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, General Life Satisfaction.||||.024
71837363|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.439|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Meaning \& Purpose.||||.439
71837364|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.025|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Emotional Support.||||.025
71837365|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.007|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Instrumental Support.||||.007
71837366|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Friendship.||||.014
71837367|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.398|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Loneliness.||||.398
71837368|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.064|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Rejection.||||.064
71837369|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.368|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Hostility.||||.368
71837370|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.504|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Self-Efficacy.||||.504
71837371|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.371|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Perceived Stress.||||.371
71837372|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.438|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Affect.||||.438
71837373|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.096|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Fear-Somatic Arousal.||||.096
71837374|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.132|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Sadness.||||.132
71837375|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.951|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Affect.||||.951
71837376|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.852|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Hostility.||||.852
71837377|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.083|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Anger-Physical Aggression.||||.083
71837378|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.391|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Negative Affect.||||.391
71837379|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.014|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Social Satisfaction.||||.014
71837380|NCT03378570|143181529|OTHER|comparative effectiveness trial||||||0.109|||||||t-test, 2 sided|||The null hypothesis of this study was that there would be no differences between targets across all measures. Results below are for the subscale, Psychological Well Being.||||.109
71837381|NCT03378570|143181530|SUPERIORITY|||||||0.231||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.875 Week 1 p = 0.084 Week 2 p = 0.277 Week 3 p = 0.686 Week 4 p = 0.369 Week 5 p = 0.806"||||||0.231
71756537|NCT03755934|143016624|SUPERIORITY||LS mean estimate|-1.39|STANDARD_ERROR_OF_MEAN|0.407||0.0009|TWO_SIDED|95.0|-2.19|-0.58||ANCOVA by dose using NRS baseline value and co-medication as covariates, with CFB to Week 12 (LOCF) as dependent variable was used to derive p-value.|ANCOVA|||||-0.58|-2.19|0.0009
71756538|NCT00307801|143016647|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
71756539|NCT03431259|143016701|SUPERIORITY|||||||0.0574|||||||Chi-squared|||||||.0574
71756540|NCT03431259|143016701|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.570
71756541|NCT00551642|143016703|OTHER||Odds Ratio (OR)|1.05||||0.734|TWO_SIDED||||||Wald Chi-square|||||||0.7340
71756542|NCT03994081|143016711|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||||||0.332
71756543|NCT03994081|143016712|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.790
71756544|NCT03994081|143016713|SUPERIORITY|||||||0.464|||||||Pearson's correlation|||||||0.464
71756545|NCT03994081|143016713|SUPERIORITY|||||||0.765|||||||Pearson's correlation|||||||0.765
71788455|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.28|||<|0.0001|TWO_SIDED|95.0|-18.18|-8.38|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-8.38|-18.18|<.0001
71788456|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.2||||0.0038|TWO_SIDED|95.0|-12.06|-2.33|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.33|-12.06|0.0038
71788457|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.9||||0.0142|TWO_SIDED|95.0|1.19|10.61|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||10.61|1.19|0.0142
71788458|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.92||||0.0414|TWO_SIDED|95.0|0.19|9.66|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.66|0.19|0.0414
71788459|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.21||||0.6165|TWO_SIDED|95.0|-3.53|5.95|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.95|-3.53|0.6165
71756546|NCT03994081|143016714|SUPERIORITY|||||||0.072|||||||Pearson's correlation|||||||0.072
71756547|NCT03994081|143016714|SUPERIORITY|||||||0.811|||||||Pearson's correlation|||||||0.811
71756548|NCT03955146|143016727|OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.062||0.2926|TWO_SIDED|95.0|-0.06|0.19|||Mixed Models Analysis|||||0.19|-0.06|0.2926
71756549|NCT04363320|143016736|SUPERIORITY||Slope|0.538|STANDARD_DEVIATION|0.169||0.002|TWO_SIDED|||||a prior threshold 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.002
71756550|NCT04363320|143016736|SUPERIORITY||Slope|0.38|STANDARD_DEVIATION|0.113||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.0008
71756551|NCT04363320|143016736|SUPERIORITY||Slope|0.207|STANDARD_DEVIATION|0.129||0.111|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.111
71756552|NCT04363320|143016736|SUPERIORITY||Slope|0.017|STANDARD_DEVIATION|0.014||0.235|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.235
71756553|NCT04363320|143016737|SUPERIORITY||Slope|0.153|STANDARD_DEVIATION|0.218||0.485|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in new patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.485
71756554|NCT04363320|143016737|SUPERIORITY||Slope|0.642|STANDARD_DEVIATION|0.19||0.0008|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new Justice Involved Person counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.0008
71756555|NCT04363320|143016737|SUPERIORITY||Slope|-0.377|STANDARD_DEVIATION|0.154||0.015|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Methadone) for Sustainability Phase (from 13 to 24 months)||||0.015
71756556|NCT04363320|143016737|SUPERIORITY||Slope|-0.02|STANDARD_DEVIATION|0.017||0.241|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in new patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.241
71756557|NCT04363320|143016738|SUPERIORITY||Slope|1.912|STANDARD_DEVIATION|0.438||2e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Intervention Phase (from baseline to 12 months)||||0.00002
71756558|NCT04363320|143016738|SUPERIORITY||Slope|0.855|STANDARD_DEVIATION|0.206||4e-05|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Intervention Phase (from baseline to 12 months)||||0.00004
71756559|NCT04363320|143016738|SUPERIORITY||Slope|0.322|STANDARD_DEVIATION|0.206||0.118|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Methadone) for Intervention Phase (from baseline to 12 months)||||0.118
71756560|NCT04363320|143016738|SUPERIORITY||Slope|0.073|STANDARD_DEVIATION|0.031||0.02|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Intervention Phase (from baseline to 12 months)||||0.020
71756561|NCT04363320|143016739|SUPERIORITY||Slope|0.617|STANDARD_DEVIATION|0.307||0.045|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Combined MOUD) for Sustainability Phase (from 13 to 24 months)||||0.045
71756562|NCT04363320|143016739|SUPERIORITY||Slope|1.103|STANDARD_DEVIATION|0.229||2e-06|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Buprenorphine) for Sustainability Phase (from 13 to 24 months)||||0.000002
71756563|NCT04363320|143016739|SUPERIORITY||Slope|-0.387|STANDARD_DEVIATION|0.218||0.076|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month|Change in census patient counts (Methadone) for Sustainability Phase (13 to 24 months)||||0.076
71756564|NCT04363320|143016739|SUPERIORITY||Slope|0.086|STANDARD_DEVIATION|0.036||0.019|TWO_SIDED|||||a priori threshold: 0.05|Mixed Models Analysis||Slope is per month.|Change in census patient counts (Naltrexone) for Sustainability Phase (from 13 to 24 months)||||0.019
71756565|NCT02628873|143016752|EQUIVALENCE|Degree of agreement between the 2 Assessors|Degree of agreement / Kappa|0.48|||<|0.01|TWO_SIDED||||||Kappa|||||||< 0.01
71756566|NCT02628873|143016753|SUPERIORITY|T-test to determine whether one method had greater reported pain|Mean Difference (Final Values)|-0.925|STANDARD_DEVIATION|2.71|<|0.3|TWO_SIDED|95.0|-2.69|1.0|||t-test, 2 sided|||||1.00|-2.69|< 0.30
71756567|NCT02628873|143016754|SUPERIORITY||Mean Difference (Final Values)|-0.431|STANDARD_DEVIATION|2.76|<|0.67|TWO_SIDED|95.0|-2.4|1.56|||t-test, 2 sided|Paired t-test (pre-procedure versus post-procedure)||||1.56|-2.40|< 0.67
71756568|NCT00541658|143016755|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.233|||||TWO_SIDED|95.0|-0.812|0.345|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.345|-0.812|
71756569|NCT00541658|143016755|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.296|||||TWO_SIDED|95.0|-0.869|0.277|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.277|-0.869|
71756570|NCT00541658|143016756|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265||||0.2955|TWO_SIDED|95.0|-0.763|0.232|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant used.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.232|-0.763|0.2955
71756571|NCT00541658|143016757|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.131|||||TWO_SIDED|95.0|-0.674|0.412|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.412|-0.674|
71788460|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.24||||0.0005|TWO_SIDED|95.0|-14.44|-4.05|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.05|-14.44|0.0005
71788461|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.92|||<|0.0001||95.0|-17.17|-6.68|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-6.68|-17.17|<.0001
71837382|NCT03378570|143181531|SUPERIORITY|||||||0.963||||||Week 6-7 Follow-up p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~Evaluation p = 0.570 Week 2-3 Follow-up p = 0.063 Week 4-5 Follow-up p = 0.792"||||||0.963
71756572|NCT00541658|143016757|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|0.156|||||TWO_SIDED|95.0|-0.382|0.695|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.695|-0.382|
71788462|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.95||||0.0008|TWO_SIDED|95.0|-14.16|-3.74|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.74|-14.16|0.0008
71788463|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.0127|TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.64|0.08|0.0127
71671341|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
71671342|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
71671343|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
71788464|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.0005|TWO_SIDED|95.0|0.22|0.79|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.79|0.22|0.0005
71788465|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21||||0.1453|TWO_SIDED|95.0|-0.07|0.49|||ANCOVA|||Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.07|0.1453
71788466|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.34||||0.1033|TWO_SIDED|95.0|-0.88|9.57|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.57|-0.88|0.1033
71788467|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14||||0.0007|TWO_SIDED|95.0|3.88|14.41|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||14.41|3.88|0.0007
71788468|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.56||||0.337|TWO_SIDED|95.0|-2.68|7.81|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.81|-2.68|0.3370
71671344|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|-25.0||||0.5408|TWO_SIDED|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||27.0|-77.0|0.5408
71837383|NCT03378570|143181532|SUPERIORITY|||||||0.051||||||Week 6 timepoint p-value listed above|Mixed Models Analysis|"Other timepoint p-values below:~First Visit p = 0.772 Week 1 p = 0.194 Week 2 p = 0.127 Week 3 p = 0.196 Week 4 p = 0.079 Week 5 p = 0.187"||||||0.051
71892261|NCT01587989|143306314|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED||||||ANCOVA|||Adjusted change in DAS28 score from Weeks 12-24.||||0.304
71892262|NCT01587989|143306315|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED||||||Fisher Exact|||||||0.732
71671345|NCT03349060|142860147|SUPERIORITY||Difference in Percentage|24.6||||0.3173|TWO_SIDED|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||63.6|-14.4|0.3173
71671346|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-2.8||||0.0006|TWO_SIDED|95.0|-4.4|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-1.2|-4.4|0.0006
71892263|NCT01587989|143306316|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Fisher Exact|||||||0.207
71756573|NCT00541658|143016758|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.258|||||TWO_SIDED|95.0|-0.836|0.321|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.321|-0.836|
71756574|NCT00541658|143016758|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.322|||||TWO_SIDED|95.0|-0.9|0.256|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.256|-0.900|
71756575|NCT00541658|143016759|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.154|||||TWO_SIDED|95.0|-1.903|-0.405|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.405|-1.903|
71892264|NCT01587989|143306317|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Fisher Exact|||||||0.453
71892265|NCT01587989|143306318|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||Fisher Exact|||||||0.084
71892266|NCT01587989|143306319|SUPERIORITY_OR_OTHER|||||||0.842|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.842
71671347|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.9|-4.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-7.9|<0.0001
71671348|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.6|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-2.0|-5.6|<0.0001
71788469|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.01||||0.3308|TWO_SIDED|95.0|-2.05|6.07|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.07|-2.05|0.3308
71788470|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7||||0.7364|TWO_SIDED|95.0|-3.39|4.8|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.80|-3.39|0.7364
71788471|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.76||||0.7132|TWO_SIDED|95.0|-3.31|4.84|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.84|-3.31|0.7132
71788472|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.9||||0.0002|TWO_SIDED|95.0|-10.54|-3.25|||ANCOVA|||Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-3.25|-10.54|0.0002
71788473|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.25|||<|0.0001|TWO_SIDED|95.0|-11.94|-4.55|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-4.55|-11.94|<.0001
71788474|NCT00333866|143074525|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.36||||0.0197|TWO_SIDED|95.0|-8.02|-0.7|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.70|-8.02|0.0197
71788475|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.17||||0.3627|TWO_SIDED|95.0|-0.54|0.2|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.20|-0.54|0.3627
71788476|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26||||0.1686|TWO_SIDED|95.0|-0.63|0.11|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.11|-0.63|0.1686
71788477|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.3468|TWO_SIDED|95.0|-0.55|0.19|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-0.55|0.3468
71788478|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7147|TWO_SIDED|95.0|-0.71|0.49|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.49|-0.71|0.7147
71788479|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.63||||0.0409|TWO_SIDED|95.0|-1.23|-0.03|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.03|-1.23|0.0409
71788480|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04||||0.9077|TWO_SIDED|95.0|-0.56|0.63|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.63|-0.56|0.9077
71788481|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5923|TWO_SIDED|95.0|-0.64|0.37|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.37|-0.64|0.5923
71671349|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.2|-6.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-6.6|-10.2|<0.0001
71788482|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61||||0.0174|TWO_SIDED|95.0|-1.12|-0.11|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.11|-1.12|0.0174
71788483|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16||||0.5408|TWO_SIDED|95.0|-0.66|0.35|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.66|0.5408
71788484|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.7236|TWO_SIDED|95.0|-0.57|0.4|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.40|-0.57|0.7236
71788485|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.71||||0.0045|TWO_SIDED|95.0|-1.19|-0.22|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.22|-1.19|0.0045
71788486|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5613||95.0|-0.63|0.34|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.63|0.5613
71892267|NCT01587989|143306320|SUPERIORITY_OR_OTHER|||||||0.417|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Physical standardized value||||0.417
71788487|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14||||0.5609|TWO_SIDED|95.0|-0.6|0.33|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.33|-0.60|0.5609
71788488|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75||||0.0016|TWO_SIDED|95.0|-1.22|-0.28|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.28|-1.22|0.0016
71788489|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.3692|TWO_SIDED|95.0|-0.68|0.25|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.68|0.3692
71788490|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.3294|TWO_SIDED|95.0|-0.73|0.25|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.25|-0.73|0.3294
71788491|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56||||0.027|TWO_SIDED|95.0|-1.05|-0.06|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.06|-1.05|0.0270
71788492|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.8432|TWO_SIDED|95.0|-0.54|0.44|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.54|0.8432
71788493|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46||||0.0806|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.06|-0.98|0.0806
71788494|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53||||0.047|TWO_SIDED|95.0|-1.06|-0.01|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.01|-1.06|0.0470
71788495|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23||||0.3845|TWO_SIDED|95.0|-0.75|0.29|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-0.75|0.3845
71788496|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12||||0.6326|TWO_SIDED|95.0|-0.37|0.6|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.60|-0.37|0.6326
71788497|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22||||0.374|TWO_SIDED|95.0|-0.71|0.27|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.27|-0.71|0.3740
71788498|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03||||0.8936|TWO_SIDED|95.0|-0.45|0.52|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.52|-0.45|0.8936
71788499|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19||||0.4743|TWO_SIDED|95.0|-0.73|0.34|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.73|0.4743
71788500|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64||||0.0192|TWO_SIDED|95.0|-1.18|-0.1|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.10|-1.18|0.0192
71788501|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18||||0.5101|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.35|-0.71|0.5101
71788502|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2||||0.4617|TWO_SIDED|95.0|-0.75|0.34|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.34|-0.75|0.4617
71788503|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.97||||0.0006|TWO_SIDED|95.0|-1.51|-0.42|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-0.42|-1.51|0.0006
71671350|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-2.7||||0.0096|TWO_SIDED|95.0|-4.7|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-4.7|0.0096
71788504|NCT00333866|143074526|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33||||0.229|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.21|-0.88|0.2290
71788505|NCT00333866|143074527|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.42|TWO_SIDED|95.0|-4.95|2.06|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.06|-4.95|0.4200
71892268|NCT01587989|143306320|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Mental standardized value||||0.112
71892269|NCT01587989|143306321|SUPERIORITY_OR_OTHER|||||||0.655|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.655
71892270|NCT01587989|143306321|SUPERIORITY_OR_OTHER|||||||0.839|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Pain||||0.839
71892271|NCT01587989|143306322|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Effectiveness||||0.580
71892272|NCT01587989|143306322|SUPERIORITY_OR_OTHER|||||||0.975|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Side-effects||||0.975
71892273|NCT01587989|143306322|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Convenience||||0.421
71892274|NCT01587989|143306322|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Global satisfaction||||0.277
71892275|NCT00275561|143306325|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Fisher Exact|||||||0.74
71892276|NCT00275561|143306326|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Fisher Exact|||||||0.49
71892277|NCT00275561|143306327|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71892278|NCT00963807|143306338|SUPERIORITY_OR_OTHER|||||||0.336|||||||t-test, 2 sided|||||||0.336
71892279|NCT00684177|143306341|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.4||||0.098|TWO_SIDED|95.0|-1.6|18.4|||Chi-squared|||||18.4|-1.6|0.098
71892280|NCT00684177|143306342|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
71892281|NCT00684177|143306343|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.1||||0.04|TWO_SIDED|95.0|0.6|23.6|||Chi-squared|||||23.6|0.6|0.04
71892282|NCT02511522|143306383|SUPERIORITY|||||||0.004|||||||Cochran-Mantel-Haenszel|Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.004
71892283|NCT02511522|143306384|SUPERIORITY|||||||0.068|||||||Log Rank|Stratified Log Rank test adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.068
71788506|NCT00333866|143074527|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.85||||0.0012|TWO_SIDED|95.0|-9.38|-2.31|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.31|-9.38|0.0012
71788507|NCT00333866|143074527|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.17||||0.5126|TWO_SIDED|95.0|-4.68|2.34|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||2.34|-4.68|0.5126
71788508|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51||||0.7781|TWO_SIDED|95.0|-4.07|3.05|||ANCOVA|||Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.05|-4.07|0.7781
71788509|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.2792|TWO_SIDED|95.0|-1.62|5.59|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.59|-1.62|0.2792
71788510|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.58||||0.7512|TWO_SIDED|95.0|-3.0|4.15|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.15|-3.00|0.7512
71788511|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.02||||0.649|TWO_SIDED|95.0|-3.39|5.43|||ANCOVA|||Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.43|-3.39|0.6490
71788512|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5||||0.5105|TWO_SIDED|95.0|-2.96|5.96|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.96|-2.96|0.5105
71788513|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.39||||0.8625|TWO_SIDED|95.0|-4.04|4.82|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|-4.04|0.8625
71788514|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.87||||0.1489|TWO_SIDED|95.0|-1.39|9.12|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.12|-1.39|0.1489
71788515|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.24||||0.0213|TWO_SIDED|95.0|0.93|11.54|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||11.54|0.93|0.0213
71788516|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.162|TWO_SIDED|95.0|-1.51|9.02|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.02|-1.51|0.1620
71788517|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.85||||0.2446|TWO_SIDED|95.0|-1.95|7.65|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.65|-1.95|0.2446
71788518|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.01||||0.0429|TWO_SIDED|95.0|0.16|9.85|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.85|0.16|0.0429
71788519|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.35||||0.1721|TWO_SIDED|95.0|-1.46|8.16|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.16|-1.46|0.1721
71788520|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.08||||0.0291|TWO_SIDED|95.0|0.42|7.74|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||7.74|0.42|0.0291
71788521|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.93||||0.0017|TWO_SIDED|95.0|2.23|9.62|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||9.62|2.23|0.0017
71788522|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.32||||0.0763|TWO_SIDED|95.0|-0.35|6.99|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.35|0.0763
71671351|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-7.2|||<|0.0001|TWO_SIDED|95.0|-9.3|-5.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-5.2|-9.3|<0.0001
71892284|NCT02511522|143306385|SUPERIORITY|||||||0.45|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.45
71671352|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-3.1||||0.0049|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.9|-5.2|0.0049
71788523|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58||||0.1524|TWO_SIDED|95.0|-0.95|6.11|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.11|-0.95|0.1524
71788524|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.36||||0.0032|TWO_SIDED|95.0|1.8|8.93|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.93|1.80|0.0032
71788525|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.82||||0.118|TWO_SIDED|95.0|-0.72|6.36|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.36|-0.72|0.1180
71788526|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.15||||0.1081|TWO_SIDED|95.0|-0.69|6.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||6.99|-0.69|0.1081
71788527|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1||||0.0101|TWO_SIDED|95.0|1.22|8.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||8.99|1.22|0.0101
71788528|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.75||||0.7031|TWO_SIDED|95.0|-3.1|4.6|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.60|-3.10|0.7031
71788529|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.27||||0.4253|TWO_SIDED|95.0|-1.86|4.39|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.39|-1.86|0.4253
71788530|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.091|TWO_SIDED|95.0|-0.44|5.89|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.89|-0.44|0.0910
71788531|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.82||||0.2526|TWO_SIDED|95.0|-1.3|4.95|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.95|-1.30|0.2526
71788532|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62||||0.0195|TWO_SIDED|95.0|0.42|4.82|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.82|0.42|0.0195
71788533|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.66||||0.0013|TWO_SIDED|95.0|1.44|5.88|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||5.88|1.44|0.0013
71788534|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.14||||0.0568|TWO_SIDED|95.0|-0.06|4.34|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||4.34|-0.06|0.0568
71788535|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.8529|TWO_SIDED|95.0|-1.54|1.27|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.27|-1.54|0.8529
71788536|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54||||0.4564|TWO_SIDED|95.0|-0.88|1.96|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.96|-0.88|0.4564
71892285|NCT02511522|143306386|SUPERIORITY|||||||0.07|||||||Cochran-Mantel-Haenszel|adjusting for the stratification factor (Hepatocellular carcinoma versus liver metastases)||||||0.07
71892286|NCT02660580|143306387|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval \[-15%, 15%\]).|Least Square (LS) Mean difference|0.88|||||TWO_SIDED|95.0|-1.21|2.98||||||||2.98|-1.21|
71892287|NCT02660580|143306403|EQUIVALENCE|MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).|Percentage difference|-1.9|||||TWO_SIDED|95.0|-7.82|4.07||||||||4.07|-7.82|
71671353|NCT03349060|142860148|SUPERIORITY||Difference in LS mean|-6.9|||<|0.0001|TWO_SIDED|95.0|-9.0|-4.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-4.7|-9.0|<0.0001
71671354|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.4||||0.002|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.1|-0.6|0.0020
71671355|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.0|<0.0001
71671356|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.5||||0.0011|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.7|0.0011
71671357|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.7|-1.2|<0.0001
71671358|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.5||||0.002|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0020
71892288|NCT01381094|143306447|SUPERIORITY||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|0.24|
71671359|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.6|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.2|<0.0001
71671360|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.5||||0.0014|TWO_SIDED|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.2|-0.8|0.0014
71671361|NCT03349060|142860149|SUPERIORITY||Difference in LS mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||-0.6|-1.3|<0.0001
71671362|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|6.0||||0.0575|TWO_SIDED|95.0|0.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||11.7|0.3|0.0575
71671363|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|18.1||||0.0002|TWO_SIDED|95.0|10.7|25.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||25.5|10.7|0.0002
71671364|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|9.2||||0.0411|TWO_SIDED|95.0|1.3|17.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||17.1|1.3|0.0411
71671365|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.9|35.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||35.5|16.9|<0.0001
71671366|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|8.9||||0.0781|TWO_SIDED|95.0|-0.1|18.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||18.0|-0.1|0.0781
71671367|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|26.2|||<|0.0001|TWO_SIDED|95.0|16.2|36.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||36.3|16.2|<0.0001
71892289|NCT01381094|143306447|SUPERIORITY||Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.2|1.33||||||||1.33|0.20|
71671368|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|14.2||||0.0075|TWO_SIDED|95.0|5.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||23.2|5.3|0.0075
71788537|NCT00333866|143074528|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13||||0.8576|TWO_SIDED|95.0|-1.28|1.54|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.54|-1.28|0.8576
71892290|NCT01381094|143306447|SUPERIORITY||Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.73|1.83||||||||1.83|0.73|
71892291|NCT01381094|143306447|SUPERIORITY||Mean Difference (Net)|1.45|||||TWO_SIDED|95.0|0.91|2.0||||||||2.00|0.91|
71892292|NCT01381094|143306447|SUPERIORITY||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<0.0001
71671369|NCT03349060|142860150|SUPERIORITY||Difference in Percentage|29.3|||<|0.0001|TWO_SIDED|95.0|19.6|38.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.||38.9|19.6|<0.0001
71671370|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.034||||0.0453|TWO_SIDED|95.0|0.001|0.066|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.066|0.001|0.0453
71671371|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.068|||<|0.0001|TWO_SIDED|95.0|0.036|0.101|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.101|0.036|<0.0001
71671372|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.025||||0.1821|TWO_SIDED|95.0|-0.012|0.062|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.062|-0.012|0.1821
71671373|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.055||||0.0038|TWO_SIDED|95.0|0.018|0.092|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.092|0.018|0.0038
71671374|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.048||||0.0241|TWO_SIDED|95.0|0.006|0.09|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.090|0.006|0.0241
71671375|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.093|||<|0.0001|TWO_SIDED|95.0|0.051|0.134|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.134|0.051|<0.0001
71788538|NCT00333866|143074529|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29||||0.7384|TWO_SIDED|95.0|-1.98|1.4|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.40|-1.98|0.7384
71788539|NCT00333866|143074529|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.41||||0.1044|TWO_SIDED|95.0|-3.12|0.29|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.29|-3.12|0.1044
71788540|NCT00333866|143074529|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87||||0.3137|TWO_SIDED|95.0|-2.58|0.83|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.83|-2.58|0.3137
71788541|NCT00333866|143074530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.09|TWO_SIDED|95.0|-1.28|0.09|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.09|-1.28|0.0900
71788542|NCT00333866|143074530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5||||0.1564|TWO_SIDED|95.0|-1.2|0.19|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.19|-1.20|0.1564
71788543|NCT00333866|143074530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.11||||0.7519|TWO_SIDED|95.0|-0.8|0.58|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.58|-0.80|0.7519
71788544|NCT00333866|143074530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15||||0.6416|TWO_SIDED|95.0|-0.5|0.8|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.80|-0.50|0.6416
71788545|NCT00333866|143074530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.59||||0.0778|TWO_SIDED|95.0|-1.25|0.07|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.07|-1.25|0.0778
71788546|NCT00333866|143074530|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21||||0.5191|TWO_SIDED|95.0|-0.87|0.44|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||0.44|-0.87|0.5191
71788547|NCT00333866|143074531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.44||||0.534|TWO_SIDED|95.0|-5.97|3.09|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||3.09|-5.97|0.5340
71788548|NCT00333866|143074531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.44||||0.0014|TWO_SIDED|95.0|-12.0|-2.88|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||-2.88|-12.00|0.0014
71788549|NCT00333866|143074531|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56||||0.2694|TWO_SIDED|95.0|-7.09|1.98|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.||1.98|-7.09|0.2694
71788550|NCT00333866|143074532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|263.77||||0.1277|TWO_SIDED|95.0|-75.78|603.33|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.||603.33|-75.78|0.1277
71892293|NCT01381094|143306448|SUPERIORITY||||||=|0.9355|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9355
71892294|NCT01381094|143306448|SUPERIORITY||||||=|0.6594|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6594
71892295|NCT01381094|143306448|SUPERIORITY||||||=|0.0203|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0203
71892296|NCT01381094|143306448|SUPERIORITY||||||=|0.0369|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0369
71892297|NCT01381094|143306448|SUPERIORITY|p-value was based on the comparison within treatment group (Change from Baseline to Week 1).|||||=|0.3713|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.3713
71892298|NCT01381094|143306448|SUPERIORITY||||||=|0.163|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1630
71671376|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.044||||0.0461|TWO_SIDED|95.0|0.001|0.087|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.087|0.001|0.0461
71756576|NCT00541658|143016759|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.044|||||TWO_SIDED|95.0|-1.789|-0.299|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.299|-1.789|
71756577|NCT00541658|143016760|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.059|||||TWO_SIDED|95.0|-1.762|-0.355|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.355|-1.762|
71788551|NCT00333866|143074532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|47.89||||0.7829|TWO_SIDED|95.0|-293.2|389.02|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||389.02|-293.2|0.7829
71892299|NCT01381094|143306448|SUPERIORITY||||||=|0.7615|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7615
71788552|NCT00333866|143074532|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.51||||0.9471|TWO_SIDED|95.0|-351.9|328.86|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.||328.86|-351.9|0.9471
71788553|NCT01454947|143074534|SUPERIORITY|||||||0.007||||||P values computed using difference between proportions (z value) with Bonferroni correction.|2 proportion Z-test|||||||0.007
71788554|NCT00673465|143074543|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.4||||0.5269|TWO_SIDED|95.0|-18.5|9.7|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||9.7|-18.5|0.5269
71756578|NCT00541658|143016760|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.922|||||TWO_SIDED|95.0|-1.62|-0.223|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.223|-1.620|
71892300|NCT01381094|143306448|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0040
71788555|NCT00673465|143074543|SUPERIORITY_OR_OTHER||Difference in least squares mean|-53.9|||<|0.0001|TWO_SIDED|95.0|-68.1|-39.8|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-39.8|-68.1|<0.0001
71756579|NCT00541658|143016761|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0524|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0524
71756580|NCT00541658|143016761|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.1207|TWO_SIDED|95.0|0.99|1.15|||Fisher Exact|||||1.15|0.99|0.1207
71756581|NCT00541658|143016762|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.0729|TWO_SIDED|95.0|1.0|1.15|||Fisher Exact|||||1.15|1.00|0.0729
71756582|NCT00541658|143016762|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.06||||0.1639|TWO_SIDED|95.0|0.98|1.14|||Fisher Exact|||||1.14|0.98|0.1639
71788556|NCT00673465|143074547|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.81||||0.741|TWO_SIDED|95.0|-20.1|14.5|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||14.5|-20.1|0.7410
71788557|NCT00673465|143074547|SUPERIORITY_OR_OTHER||Difference in least squares mean|-63.6|||<|0.0001|TWO_SIDED|95.0|-80.9|-46.2|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-46.2|-80.9|<0.0001
71788558|NCT00673465|143074549|SUPERIORITY_OR_OTHER||Difference in least squares mean|-3.59||||0.3146|TWO_SIDED|95.0|-10.8|3.6|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||3.6|-10.8|0.3146
71788559|NCT00673465|143074549|SUPERIORITY_OR_OTHER||Difference in least squares mean|-26.6|||<|0.0001|TWO_SIDED|95.0|-33.8|-19.4|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.||||-19.4|-33.8|<0.0001
71837384|NCT04169373|143181535|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|17.9|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.||34.9|17.9|<0.0001
71892301|NCT01381094|143306448|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0003
71813289|NCT01342458|143129058|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Mixed Models Analysis|||Sample size was calculated based on pain WOMAC score and was accomplished using a moderate effect size (f=0.30). Standard deviation estimates were taken from our previous study. A sample size of 56 patients was needed to provide 80% power for detecting a moderate effect difference between the highest and lowest group pain means, with an alpha level of 0.05, a statistical design of F test of repeated measures (between and within effects), and assuming a 10% loss to follow-up.||||0.006
71813290|NCT01342458|143129058|SUPERIORITY_OR_OTHER||Effect Size|1.46|||<|0.001|TWO_SIDED||||||post hoc newman keuls|||From baseline to 3rd month.||||<0.001
71813291|NCT01342458|143129058|SUPERIORITY_OR_OTHER||Effect size|1.94|||<|0.001|TWO_SIDED||||||post hoc Newman Keuls|||From baseline to 6th month.||||<0.001
71671377|NCT03349060|142860151|SUPERIORITY||Difference in LS mean|0.064||||0.0037|TWO_SIDED|95.0|0.021|0.107|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.107|0.021|0.0037
71837385|NCT04169373|143181536|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP status.|Response Rate Difference = Upadacitinib - Placebo|"Efficacy analyses and hypothesis testing including multiplicity adjustment were performed independently for Study 1 and Study 2.~Binary endpoints in Study 2 were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the main stratification factor of positivity for MRI inflammation in the sacroiliac joints and screening hsCRP status (MRI-positive and hsCRP \> ULN vs MRI-positive and hsCRP ≤ ULN vs MRI-negative and hsCRP \> ULN)."||32.3|12.1|<0.0001
71788560|NCT02648178|143074563|OTHER|We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, by week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), Nicotine, Cotinine, Hydro and Creatinine and CO (Carbon Monoxide) level,by week and their interactions.||||||||||||We tested whether there were significant associations between cigarette smoking and e-cigarette smoking, as well as whether there were significant associations between biomarkers mentioned above with CO level.||We provided estimated values of coefficients from model and their 95% confidence intervals.|||We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.|||
71788561|NCT01285310|143074565|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.4||||0.3134|TWO_SIDED|95.0|-27.1|7.0|||Chi-squared||2-sided 95% CI of the proportion difference is based on a normal approximation to the binomial distribution|Significance testing was done using the following closed procedure; if the overall test among treatments is statistically significant at the 0.05 level, pair-wise comparisons (30 mg versus PBO, and 20 mg versus PBO, using a 0.05 two-sided significance level) will be performed||7.0|-27.1|0.3134
71788562|NCT01285310|143074565|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.2||||0.8721|TWO_SIDED|95.0|-16.2|13.8|||Chi-squared||2-sided 95% CI is based on a normal approximation to the binomial distribution|||13.8|-16.2|0.8721
71788563|NCT01285310|143074566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.004|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788564|NCT01285310|143074566|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.091|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788565|NCT01285310|143074567|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-4.5||||||||||||||||||
71788566|NCT01285310|143074567|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.6||||||||||||||||||
71788567|NCT01285310|143074568|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.007||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
71788568|NCT01285310|143074568|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, treatment group as a factor and the baseline value as a covariate.|||||
71788569|NCT01285310|143074569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate|||||
71788570|NCT01285310|143074569|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.|||||
71788571|NCT01285310|143074570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.21||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.||||||
71788572|NCT01285310|143074570|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
71788573|NCT01285310|143074571|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.5||||||||||||||||||
71788574|NCT01285310|143074571|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-7.2||||||||||||||||||
71788575|NCT01285310|143074572|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, treatment group as a factor and the baseline value as a covariate.||||||
71788576|NCT01285310|143074572|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.02|||||TWO_SIDED|||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
71788577|NCT01285310|143074573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.15|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
71788578|NCT01285310|143074573|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
71788579|NCT01285310|143074574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.58|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788580|NCT01285310|143074574|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.26||||||||||||||||||
71756583|NCT00541658|143016763|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0476|TWO_SIDED|95.0|1.0|1.16|||Fisher Exact|||||1.16|1.00|0.0476
71756584|NCT00541658|143016763|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.12||||0.0014|TWO_SIDED|95.0|1.04|1.2|||ANOVA|||||1.20|1.04|0.0014
71788581|NCT01285310|143074575|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-35.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788582|NCT01285310|143074575|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-38.37|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788583|NCT01285310|143074576|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.35|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71671378|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|4.548||||0.0319|TWO_SIDED|95.0|0.397|8.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||8.700|0.397|0.0319
71671379|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|8.659|||<|0.0001|TWO_SIDED|95.0|4.496|12.822|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||12.822|4.496|<0.0001
71788584|NCT01285310|143074576|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788585|NCT01285310|143074577|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.59|||||TWO_SIDED||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788586|NCT01285310|143074577|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.84|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788587|NCT01285310|143074578|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.93|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788588|NCT01285310|143074578|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
71671380|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|4.361||||0.0702|TWO_SIDED|95.0|-0.362|9.084|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||9.084|-0.362|0.0702
71788589|NCT01285310|143074579|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71837386|NCT04169373|143181536|OTHER||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.7|4.5|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.5|1.7|
71788590|NCT01285310|143074579|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|58.05||||||||||||||||||
71788591|NCT01285310|143074580|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|7.18|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788592|NCT01285310|143074580|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-16.19|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71788593|NCT01285310|143074581|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.|||||
71756585|NCT00541658|143016764|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0547|TWO_SIDED|95.0|1.0|1.16|||ANOVA|||||1.16|1.00|0.0547
71837387|NCT04169373|143181537|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Least Squares (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.85|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.85|-1.20|<0.0001
71837388|NCT04169373|143181538|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.9|||<|0.0001|TWO_SIDED|95.0|-5.47|-2.33|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.33|-5.47|<0.0001
71837389|NCT04169373|143181539|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|26.4|||<|0.0001|TWO_SIDED|95.0|18.0|34.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||34.8|18.0|<0.0001
71837390|NCT04169373|143181540|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.9|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||36.3|17.9|<0.0001
71837391|NCT04169373|143181541|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9|||<|0.0001|TWO_SIDED|95.0|6.0|15.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||15.8|6.0|<0.0001
71837392|NCT04169373|143181542|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.11|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.11|-1.96|<0.0001
71837393|NCT04169373|143181543|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.14|<0.0001
71837394|NCT04169373|143181544|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|34.0|||<|0.0001|TWO_SIDED|95.0|26.2|41.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||41.8|26.2|<0.0001
71892302|NCT01381094|143306448|SUPERIORITY||||||=|0.3978|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3978
71892303|NCT01381094|143306448|SUPERIORITY||||||=|0.0083|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0083
71892304|NCT01381094|143306448|SUPERIORITY||||||=|0.0323|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0323
71892305|NCT01381094|143306448|SUPERIORITY||||||=|0.0003|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0003
71892306|NCT01381094|143306448|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0001
71892307|NCT01381094|143306448|SUPERIORITY||||||=|0.423|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4230
71671381|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|10.085|||<|0.0001|TWO_SIDED|95.0|5.349|14.821|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.821|5.349|<0.0001
71788594|NCT01285310|143074581|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-0.1|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate|||||
71671382|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|6.045||||0.03|TWO_SIDED|95.0|0.589|11.501|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.501|0.589|0.0300
71788595|NCT01285310|143074582|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
71788596|NCT01285310|143074582|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||||||||||||||||
71788597|NCT01285310|143074583|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-3.9||||||||||||||||||
71788598|NCT01285310|143074583|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.9||||||||||||||||||
71788599|NCT01285310|143074584|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.4||||||||||||||||||
71788600|NCT01285310|143074584|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|2.1||||||||||||||||||
71788601|NCT01285310|143074585|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-6.5||||||||||||||||||
71892308|NCT01381094|143306448|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0023
71671383|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|9.803||||0.0005|TWO_SIDED|95.0|4.368|15.237|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.237|4.368|0.0005
71788602|NCT01285310|143074585|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.2||||||||||||||||||
71788603|NCT01285310|143074586|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.3||||||||||||||||||
71892309|NCT01381094|143306448|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0009
71788604|NCT01285310|143074586|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.5||||||||||||||||||
71788605|NCT01285310|143074587|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.5||||||||||||||||||
71788606|NCT01285310|143074587|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.5||||||||||||||||||
71788607|NCT01285310|143074588|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||||||
71788608|NCT01285310|143074588|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|1.5|||||TWO_SIDED|||||||||||||
71788609|NCT01285310|143074589|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
71788610|NCT01285310|143074589|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.98|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
71788611|NCT01285310|143074590|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
71788612|NCT01285310|143074590|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-1.24||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||||||
71788613|NCT01285310|143074591|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-4.3||||||||||||||||||
71788614|NCT01285310|143074591|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|4.6||||||||||||||||||
71788615|NCT01285310|143074592|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
71813292|NCT01342458|143129058|SUPERIORITY_OR_OTHER||Effect size|0.82||||0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||0.001
71756586|NCT00541658|143016764|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.1||||0.0066|TWO_SIDED|95.0|1.03|1.18|||ANOVA|||||1.18|1.03|0.0066
71756587|NCT00541658|143016765|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.135|||||TWO_SIDED|95.0|-0.504|0.234|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.234|-0.504|
71756588|NCT00541658|143016765|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.072|||||TWO_SIDED|95.0|-0.437|0.294|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.294|-0.437|
71756589|NCT00541658|143016766|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.321|||||TWO_SIDED|95.0|-0.724|0.082|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.082|-0.724|
71788616|NCT01285310|143074592|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.|||||
71756590|NCT00541658|143016766|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.692|0.112|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.112|-0.692|
71756591|NCT00541658|143016767|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.288|||||TWO_SIDED|95.0|-0.682|0.106|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.106|-0.682|
71788617|NCT01285310|143074593|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788618|NCT01285310|143074593|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.01|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.|||||
71788619|NCT01285310|143074594|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.86|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
71756592|NCT00541658|143016767|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||TWO_SIDED|95.0|-0.681|0.101|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.101|-0.681|
71756593|NCT00541658|143016768|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.644|||||TWO_SIDED|95.0|-1.179|-0.11|||ANOVA|||||-0.110|-1.179|
71788620|NCT01285310|143074594|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-7.02|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
71788621|NCT01285310|143074595|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
71671384|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|7.569||||0.0067|TWO_SIDED|95.0|2.119|13.019|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||13.019|2.119|0.0067
71671385|NCT03349060|142860152|SUPERIORITY||Difference in LS mean|9.374||||0.0008|TWO_SIDED|95.0|3.933|14.815|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||14.815|3.933|0.0008
71671386|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|-0.004||||0.9568|TWO_SIDED|95.0|-0.137|0.13|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.130|-0.137|0.9568
71671387|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.09||||0.1782|TWO_SIDED|95.0|-0.042|0.223|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.223|-0.042|0.1782
71671388|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.174||||0.0491|TWO_SIDED|95.0|0.001|0.347|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.347|0.001|0.0491
71671389|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.284||||0.0015|TWO_SIDED|95.0|0.112|0.456|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.456|0.112|0.0015
71756594|NCT00541658|143016768|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.587|||||TWO_SIDED|95.0|-1.116|-0.059|||ANOVA|||||-0.059|-1.116|
71671390|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.004||||0.9638|TWO_SIDED|95.0|-0.185|0.194|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.194|-0.185|0.9638
71671391|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.08||||0.4016|TWO_SIDED|95.0|-0.109|0.27|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.270|-0.109|0.4016
71671392|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.007||||0.9429|TWO_SIDED|95.0|-0.184|0.198|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.198|-0.184|0.9429
71671393|NCT03349060|142860153|SUPERIORITY||Difference in LS mean|0.062||||0.5212|TWO_SIDED|95.0|-0.13|0.254|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||0.254|-0.130|0.5212
71671394|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|2.131||||0.6467|TWO_SIDED|95.0|-7.095|11.358|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||11.358|-7.095|0.6467
71788622|NCT01285310|143074595|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-37.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
71671395|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|11.549||||0.0147|TWO_SIDED|95.0|2.338|20.761|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.761|2.338|0.0147
71671396|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|6.853||||0.1894|TWO_SIDED|95.0|-3.453|17.159|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||17.159|-3.453|0.1894
71671397|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|16.99||||0.0015|TWO_SIDED|95.0|6.699|27.281|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||27.281|6.699|0.0015
71756595|NCT00541658|143016769|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.03|-0.014|||ANOVA|||||-0.014|-1.030|
71671398|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|8.672||||0.1267|TWO_SIDED|95.0|-2.518|19.862|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||19.862|-2.518|0.1267
71671399|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|9.354||||0.1009|TWO_SIDED|95.0|-1.866|20.573|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||20.573|-1.866|0.1009
71756596|NCT00541658|143016769|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.468|||||TWO_SIDED|95.0|-0.973|0.037|||ANOVA|||||0.037|-0.973|
71788623|NCT01285310|143074596|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-14.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788624|NCT01285310|143074596|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-12.5|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788625|NCT01285310|143074597|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.85|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788626|NCT01285310|143074597|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.8|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788627|NCT01285310|143074598|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.57|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788628|NCT01285310|143074598|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.72|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788629|NCT01285310|143074599|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|8.29|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788630|NCT01285310|143074599|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|67.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71671400|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|6.071||||0.1915|TWO_SIDED|95.0|-3.107|15.249|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||15.249|-3.107|0.1915
71788631|NCT01285310|143074600|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|12.05|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788632|NCT01285310|143074600|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.|||||
71788633|NCT01285310|143074601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
71788634|NCT01285310|143074601|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate|||||
71788635|NCT01285310|143074602|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|5.4||||||||||||||||||
71788636|NCT01285310|143074602|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|12.6||||||||||||||||||
71788637|NCT01285310|143074603|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.9||||||||||||||||||
71788638|NCT01285310|143074603|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.3||||||||||||||||||
71788639|NCT01285310|143074604|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-11.2||||||||||||||||||
71788640|NCT01285310|143074604|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.0||||||||||||||||||
71788641|NCT00143403|143074638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.67|1.2|||||HR: Irinotecan+5-FU/FA / 5-FU/FA|||1.20|0.67|
71788642|NCT00143403|143074638|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Log Rank|||||||0.468
71788643|NCT00514540|143074640|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.005|ONE_SIDED|95.0||||"Stoppage of trial early if 1) probability of response with the frontline treatment DC in the 1st 2 courses is unacceptably low compared to a target of 30% Pr(p1\*p2 \> .30\|data) \< 0.005, or 2) risk of a SAE is unacceptably high Pr(m \> m\* \|data) \< 0.001"|Bayesian probability model|Operating Characteristics of futility monitoring rule 1 \& safety monitoring rule 2 applied simultaneously for frontline treatment DC in courses 1 \& 2.||Disease status evaluated at the end of course 1 \& the end of course 2. Primary outcomes are response, defined as the absence of disease progression, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death. Bayesian probability model \& decision rules used to monitor patient outcomes.||||< 0.005
71788644|NCT00533845|143074649|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||t-test, 2 sided|||||||.0022
71813293|NCT01342458|143129058|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71756597|NCT00541658|143016770|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.731|0.201|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.201|-0.731|
71892310|NCT01381094|143306448|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71756598|NCT00541658|143016770|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.588|0.336|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.336|-0.588|
71788645|NCT01288469|143074656|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.82|||<|0.0001|TWO_SIDED|95.0|-65.62|-46.03||Threshold for significance ≤0.05.|ANCOVA||Alirocumab vs. placebo|Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.||-46.03|-65.62|<0.0001
71788646|NCT01867021|143074695|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.85|||||TWO_SIDED|95.0|1.66|2.06|||ANCOVA|Not applicable(NA)||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 22||2.06|1.66|
71788647|NCT01867021|143074695|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.5|||||TWO_SIDED|95.0|1.38|1.64|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 22||1.64|1.38|
71788648|NCT01867021|143074695|NON_INFERIORITY_OR_EQUIVALENCE|The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.93|1.08|||ANCOVA|||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 22||1.08|0.93|
71788649|NCT01867021|143074696|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|9.0|||||TWO_SIDED|95.0|5.6|11.5|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 22||11.5|5.6|
71788650|NCT01867021|143074696|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H3N2 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|13.0|||||TWO_SIDED|95.0|10.1|16.1|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 22||16.1|10.1|
71788651|NCT01867021|143074696|NON_INFERIORITY_OR_EQUIVALENCE|Percentage of subjects with HI seroconversion of TIV vaccine for strain B considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|-1.0|||||TWO_SIDED|95.0|-5.0|2.3|||Miettinen and Nurminen|||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 22||2.3|-5|
71788652|NCT00560859|143074723|SUPERIORITY_OR_OTHER||difference of change from baseline|2.0||||0.16|||||||ANCOVA|||||||0.16
71892311|NCT01381094|143306448|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71892312|NCT01381094|143306448|SUPERIORITY||||||=|0.5291|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5291
71788653|NCT00824512|143074760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9133|TWO_SIDED|95.0||||No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.|Non parametric ANCOVA on the rank test|The baseline value was used as a covariate.||||||0.9133
71892313|NCT01381094|143306448|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
71837395|NCT04169373|143181545|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.17|||<|0.0001|TWO_SIDED|95.0|-1.55|-0.8|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.80|-1.55|<0.0001
71837396|NCT04169373|143181546|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) model adjusted by main stratification factor of screening hsCRP level (\> ULN vs ≤ ULN).|Response Rate Difference = Upadacitinib - Placebo|||19.0|7.4|<0.0001
71671401|NCT03349060|142860154|SUPERIORITY||Difference in LS mean|12.948||||0.0064|TWO_SIDED|95.0|3.754|22.143|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.||22.143|3.754|0.0064
71837397|NCT04169373|143181547|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.24|-3.90|<0.0001
71837398|NCT04169373|143181548|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.47|-1.24|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-1.24|-2.47|<0.0001
71837399|NCT04169373|143181549|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.46|-0.18|||ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.18|-0.46|<0.0001
71837400|NCT04169373|143181550|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.9|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit and treatment-by-visit interaction, screening hsCRP level (\> ULN vs ≤ ULN) and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.9|-2.0|<0.0001
71837401|NCT04169373|143181551|OTHER||LS Mean Difference|-3.31|||<|0.0001|TWO_SIDED|95.0|-4.5|-2.12||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and screening hsCRP level as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.12|-4.50|<0.0001
71837402|NCT04169373|143181552|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.45|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.45|-0.85|<0.0001
71671402|NCT03349060|142860155|SUPERIORITY||Difference in LS mean|3.6||||0.0102|TWO_SIDED|95.0|0.9|6.4||Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.4|0.9|0.0102
71892314|NCT01381094|143306448|SUPERIORITY||||||=|0.0222|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0222
71892315|NCT01381094|143306448|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
71671403|NCT03349060|142860155|SUPERIORITY||Difference in LS mean|4.5||||0.0013|TWO_SIDED|95.0|1.8|7.3||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.3|1.8|0.0013
71671404|NCT03349060|142860156|SUPERIORITY||Difference in LS mean|1.0||||0.5241|TWO_SIDED|95.0|-2.1|4.2||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.2|-2.1|0.5241
71892316|NCT01381094|143306448|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
71837403|NCT04169373|143181553|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-3.06|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.04|||ANCOVA|ANCOVA model including treatment, main stratification factor, treatment and stratification factor interaction and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-2.04|-4.08|<0.0001
71837404|NCT04169373|143181554|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|20.1||||0.0001|TWO_SIDED|95.0|10.1|30.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.1|10.1|0.0001
71837405|NCT04169373|143181554|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.6|4.2|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.2|1.6|
71837406|NCT04169373|143181555|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|8.8||||0.0063|TWO_SIDED|95.0|2.5|15.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||15.2|2.5|0.0063
71837407|NCT04169373|143181555|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|1.3|7.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||7.0|1.3|
71837408|NCT04169373|143181556|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.92||||0.0004|TWO_SIDED|95.0|-1.42|-0.41|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.41|-1.42|0.0004
71671405|NCT03349060|142860156|SUPERIORITY||Difference in LS mean|0.9||||0.5821|TWO_SIDED|95.0|-2.3|4.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.1|-2.3|0.5821
71837409|NCT04169373|143181557|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.12||||0.0001|TWO_SIDED|95.0|-1.68|-0.55|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.55|-1.68|0.0001
71892317|NCT01381094|143306448|SUPERIORITY||||||=|0.9314|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9314
71892318|NCT01381094|143306449|SUPERIORITY||||||=|0.5219|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5219
71892319|NCT01381094|143306449|SUPERIORITY||||||=|0.6743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.6743
71892320|NCT01381094|143306449|SUPERIORITY||||||=|0.0078|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0078
71892321|NCT01381094|143306449|SUPERIORITY||||||=|0.0301|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0301
71671406|NCT03349060|142860157|SUPERIORITY||Difference in LS mean|3.8||||0.0013|TWO_SIDED|95.0|1.5|6.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||6.1|1.5|0.0013
71671407|NCT03349060|142860157|SUPERIORITY||Difference in LS mean|4.7|||<|0.0001|TWO_SIDED|95.0|2.4|7.0||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||7.0|2.4|<0.0001
71756599|NCT00541658|143016771|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.328|||||TWO_SIDED|95.0|-0.811|0.156|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.156|-0.811|
71788654|NCT00071513|143074786|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Mean changes in Short Moods and Feelings measure of depression was the unit of analysis.||||<0.05
71788655|NCT00071513|143074786|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||A secondary hypothesis of the study was that attachment to school and/or perceptions of school supportiveness would mediate the effect of the HSTS intervention on depressive symptoms.||||<0.01
71788656|NCT02260921|143074788|SUPERIORITY||Difference in Least Squares (LS) Means|-7.53||||0.0002|TWO_SIDED|95.0|-11.48|-3.58||P-values are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|ANCOVA||LS estimates are obtained by fitting an ANCOVA model with treatment as factor and WOMAC baseline pain score as a covariate.|||-3.58|-11.48|0.0002
71788657|NCT01244425|143074797|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood-ratio chi square test|||||||<0.001
71788658|NCT01244425|143074798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||likelihood ratio chi-square test|||||||<0.001
71788659|NCT01244425|143074799|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||likelihood ratio chi-square test|||||||0.028
71788660|NCT01244425|143074800|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||likelihood ratio chi-square test|||||||0.017
71788661|NCT01244425|143074801|SUPERIORITY_OR_OTHER|||||||0.293||95.0|||||likelihood ratio chi-square test|||||||0.293
71788662|NCT01244425|143074802|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||likelihood ratio chi-square test|||||||0.237
71788663|NCT01244425|143074803|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||likelihood ratio chi-square test|||||||0.808
71788664|NCT02421315|143074828|OTHER|a t-test comparing groups in a specific region-of-interest (ROI); the insula|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.057||0.0585|TWO_SIDED|95.0|-0.004|0.224|||t-test, 2 sided|||We hypothesized that compared to HC, children and adolescents with OCD would have increased activation in subcortical structures (insula, and putamen) comprising a right hemisphere dorsal frontostriatal circuit.||0.224|-0.004|0.0585
71813294|NCT01342458|143129059|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.015
71813295|NCT01342458|143129059|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71788665|NCT02421315|143074829|SUPERIORITY|We selected 'arbitrary units' as the unit of measure here because we are looking at connectivity strengths|Mean Difference (Final Values)|0.49512921|STANDARD_ERROR_OF_MEAN|0.06553315||0.037|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p\<.05 with 20,000 permutations was used."|t-test, 1 sided||Direction of the comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the FC-strength indices between 352 regions. Edge-wise functional connectivity analyses was then be conducted across the resulting matrix comprised of 352 nodes and 123,904 edges, using the Network-Based Statistics (NBS) Toolbox. We hypothesized that youth with OCD would show altered FC between task-control circuit regions.||||.037
71788666|NCT02421315|143074829|OTHER||Slope|-0.521|||<|0.05|TWO_SIDED||||||Regression, Linear|||Separate cross-lagged panel models were computed in the OCD group for the three functional connections that differed significantly across groups at baseline (see Statistical Analysis 1). These models were constructed using IBM SPSS Amos (v.23) to test for directional relationships between OCD symptoms and FC pre- to post-treatment in the OCD patients. CY-BOCS total scores at each time point were used as the OCD symptoms measure.||||<.05
71788667|NCT02421315|143074830|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0464|TWO_SIDED|95.0|0.0018|0.218|||t-test, 2 sided|||||0.218|0.0018|0.0464
71788668|NCT02421315|143074831|SUPERIORITY|only participants were assigned to groups (OCD, HC) and we measured streamline count in these participants to index structural connectivity|Slope|-102.67|||<|0.025|TWO_SIDED|||||"NBS controls for family-wise error rate using permutation testing to identify components or clusters of contiguous region-to-region connections. A statistical threshold of p=.025 with 10,000 permutations was used."|Regression, Linear||Direction of comparison: HC\>OCD|Whole-Brain Connectome-Level Analyses were performed on the structural connectivity indices (streamline count) between 164 regions. Edge-wise structural connectivity analyses was then be conducted across the resulting matrix comprised of 164 nodes and 26,896 edges, using the Network-Based Statistics (NBS) Toolbox.||||<0.025
71788669|NCT02480114|143074840|SUPERIORITY||Odds Ratio (OR)|0.549||||0.004|TWO_SIDED|95.0|0.364|0.827|||Proportional Odds Regression|||||0.827|0.364|0.004
71788670|NCT02480114|143074841|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1
71788671|NCT02480114|143074842|SUPERIORITY||Odds Ratio (OR)|0.371|||<|0.001|TWO_SIDED|95.0|0.244|0.597|||Proportional Odds Regression|||||0.597|0.244|<0.001
71788672|NCT02879305|143074870|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.81|1.07|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|
71788673|NCT02879305|143074871|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.18|||||TWO_SIDED|95.0|0.12|0.24|||||Analysis of covariance (ANCOVA) model adjusted for treatment, Baseline Hgb, dialysis type and region along with 95% CI for treatment difference (daprodustat-rhEPO).|||0.24|0.12|
71788674|NCT02879305|143074872|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.156123|TWO_SIDED|95.0|0.81|1.07||The p-value was compared against 0.0125 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.81|0.156123
71788675|NCT02879305|143074873|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.023539|TWO_SIDED|95.0|0.78|1.0||The p-value was compared against 0.006250 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.00|0.78|0.023539
71788676|NCT02879305|143074874|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.325797|TWO_SIDED|95.0|0.85|1.11||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.11|0.85|0.325797
71788677|NCT02879305|143074875|SUPERIORITY||LS mean difference|-9.1||||0.026947|TWO_SIDED|95.0|-18.4|0.2||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|ANCOVA||Analysis was carried out by using ANCOVA model with terms for treatment, Baseline monthly IV iron dose, dialysis type and region.|||0.2|-18.4|0.026947
71788678|NCT02879305|143074876|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.3281|TWO_SIDED|95.0|0.82|1.13|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.13|0.82|0.3281
71788679|NCT02879305|143074877|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3553|TWO_SIDED|95.0|0.74|1.23|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.23|0.74|0.3553
71788680|NCT02879305|143074878|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0524|TWO_SIDED|95.0|0.63|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.63|0.0524
71788681|NCT02879305|143074879|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1927|TWO_SIDED|95.0|0.56|1.25|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.25|0.56|0.1927
71788682|NCT02879305|143074880|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0351|TWO_SIDED|95.0|0.8|1.01|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.01|0.80|0.0351
71788683|NCT02879305|143074880|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
71813296|NCT01342458|143129059|SUPERIORITY_OR_OTHER||Effect size|0.7|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71813297|NCT01342458|143129059|SUPERIORITY_OR_OTHER||Effect size|0.25|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71671408|NCT03349060|142860158|SUPERIORITY||Difference in LS mean|1.7||||0.2256|TWO_SIDED|95.0|-1.0|4.4||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||4.4|-1.0|0.2256
71671409|NCT03349060|142860158|SUPERIORITY||Difference in LS mean|3.0||||0.0275|TWO_SIDED|95.0|0.3|5.8||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA|||||5.8|0.3|0.0275
71671410|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|3.9|||<|0.0001|TWO_SIDED|95.0|2.0|7.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||7.7|2.0|<0.0001
71788684|NCT02879305|143074880|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0158|TWO_SIDED|95.0|0.58|0.98|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.98|0.58|0.0158
71788685|NCT02879305|143074880|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0981|TWO_SIDED|95.0|0.47|1.17|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.17|0.47|0.0981
71788686|NCT02879305|143074880|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3258|TWO_SIDED|95.0|0.85|1.11|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.11|0.85|0.3258
71788687|NCT02879305|143074880|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0058|TWO_SIDED|95.0|0.6|0.94|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||0.94|0.60|0.0058
71788688|NCT02879305|143074881|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0872|TWO_SIDED|95.0|0.73|1.06|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.06|0.73|0.0872
71788689|NCT02879305|143074882|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.154|TWO_SIDED|95.0|0.87|1.04|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.04|0.87|0.1540
71788690|NCT02879305|143074883|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1244|TWO_SIDED|95.0|0.77|1.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.07|0.77|0.1244
71788691|NCT02879305|143074884|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.054|TWO_SIDED|95.0|0.81|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.81|0.0540
71788692|NCT02879305|143074885|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7658|TWO_SIDED|95.0|0.84|1.45|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.45|0.84|0.7658
71671411|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.1|0.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.6|0.1|<0.0001
71788693|NCT02879305|143074886|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0425|TWO_SIDED|95.0|0.69|1.02|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, dialysis type and region as covariates.|||1.02|0.69|0.0425
71788694|NCT02879305|143074887|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.12|||||TWO_SIDED|95.0|0.03|0.21||||||||0.21|0.03|
71788695|NCT02879305|143074888|SUPERIORITY||Difference in response rate|3.5||||0.0367|TWO_SIDED|95.0|-0.1|7.1|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for dialysis type, and region was used to compare the number of responders between the treatment groups.|||7.1|-0.1|0.0367
71788696|NCT02879305|143074889|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|1.06|||||TWO_SIDED|95.0|0.0|3.86|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||3.86|0.00|
71788697|NCT02879305|143074890|SUPERIORITY||Probability|0.52||||0.0805|TWO_SIDED|95.0|0.49|0.54|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.54|0.49|0.0805
71788698|NCT02879305|143074891|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.18|||||TWO_SIDED|95.0|0.28|4.05|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-rhEPO) and associated two-sided asymptotic 95% CI is presented.|||4.05|0.28|
71788699|NCT02879305|143074892|SUPERIORITY||Probability|0.53||||0.0139|TWO_SIDED|95.0|0.5|0.55|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.55|0.50|0.0139
71788700|NCT02879305|143074893|SUPERIORITY||LS mean difference|0.33||||0.6551|TWO_SIDED|95.0|-1.28|1.94|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||1.94|-1.28|0.6551
71837410|NCT04169373|143181558|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|23.8|||<|0.0001|TWO_SIDED|95.0|14.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|14.2|<0.0001
71788701|NCT02879305|143074893|SUPERIORITY||LS mean difference|-0.46||||0.1586|TWO_SIDED|95.0|-1.36|0.44|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.44|-1.36|0.1586
71788702|NCT02879305|143074893|SUPERIORITY||LS mean difference|-0.18||||0.3646|TWO_SIDED|95.0|-1.2|0.84|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in means between arms.|||0.84|-1.20|0.3646
71788703|NCT02879305|143074894|SUPERIORITY||LS mean difference|0.0||||0.5012|TWO_SIDED|95.0|-1.54|1.54|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.54|-1.54|0.5012
71788704|NCT02879305|143074894|SUPERIORITY||LS mean difference|0.45||||0.8451|TWO_SIDED|95.0|-0.42|1.31|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.31|-0.42|0.8451
71788705|NCT02879305|143074894|SUPERIORITY||LS mean difference|0.31||||0.7312|TWO_SIDED|95.0|-0.67|1.28|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, dialysis type, region and Baseline value.|||1.28|-0.67|0.7312
71671412|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|1.5||||0.6334|TWO_SIDED|95.0|0.8|3.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.0|0.8|0.6334
71671413|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.6||||0.8065|TWO_SIDED|95.0|0.2|1.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.6|0.2|0.8065
71788706|NCT02879305|143074895|SUPERIORITY||Ratio of exacerbation rate|1.0||||0.529|TWO_SIDED|95.0|0.91|1.11|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.11|0.91|0.5290
71788707|NCT02879305|143074897|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5772|TWO_SIDED|95.0|0.71|1.52|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and region.|||1.52|0.71|0.5772
71788708|NCT02879305|143074898|SUPERIORITY||LS mean difference|0.29||||0.162|TWO_SIDED|95.0|-0.29|0.86|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-0.29|0.1620
71788709|NCT02879305|143074898|SUPERIORITY||LS mean difference|0.61||||0.018|TWO_SIDED|95.0|0.04|1.18|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.18|0.04|0.0180
71788710|NCT02879305|143074898|SUPERIORITY||LS mean difference|0.33||||0.153|TWO_SIDED|95.0|-0.31|0.97|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.97|-0.31|0.1530
71788711|NCT02879305|143074898|SUPERIORITY||LS mean difference|0.53||||0.0686|TWO_SIDED|95.0|-0.17|1.22|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.22|-0.17|0.0686
71788712|NCT02879305|143074899|SUPERIORITY||LS mean difference|-0.17||||0.6807|TWO_SIDED|95.0|-0.88|0.54|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and the model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.88|0.6807
71788713|NCT02879305|143074899|SUPERIORITY||LS mean difference|0.17||||0.3256|TWO_SIDED|95.0|-0.57|0.91|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and the model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.91|-0.57|0.3256
71788714|NCT02879305|143074899|SUPERIORITY||LS mean difference|-0.01||||0.5144|TWO_SIDED|95.0|-0.81|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and the model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.81|0.5144
71788715|NCT02879305|143074899|SUPERIORITY||LS mean difference|-0.6||||0.912|TWO_SIDED|95.0|-1.47|0.27|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and the model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.27|-1.47|0.9120
71788716|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.25||||0.7432|TWO_SIDED|95.0|-0.99|0.5|||MMRM||Bodily pain,Week8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.50|-0.99|0.7432
71788717|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.58||||0.0631|TWO_SIDED|95.0|-0.16|1.33|||MMRM||Bodily pain,Week12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.33|-0.16|0.0631
71788718|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.04||||0.4604|TWO_SIDED|95.0|-0.79|0.87|||MMRM||Bodily pain,Week28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.87|-0.79|0.4604
71788719|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.28||||0.2688|TWO_SIDED|95.0|-0.6|1.15|||MMRM||Bodily pain,Week52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.15|-0.60|0.2688
71813298|NCT01342458|143129059|SUPERIORITY_OR_OTHER||Effect size|0.16|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71813299|NCT01342458|143129060|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
71813300|NCT01342458|143129060|SUPERIORITY_OR_OTHER||Effect size|1.28|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71813301|NCT01342458|143129060|SUPERIORITY_OR_OTHER||Effect size|1.58|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71813302|NCT01342458|143129060|SUPERIORITY_OR_OTHER||Effect size|0.68|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71813303|NCT01342458|143129060|SUPERIORITY_OR_OTHER||Effect size|0.42|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71837411|NCT04169373|143181558|OTHER||Odds Ratio (OR)|3.2|||||TWO_SIDED|95.0|1.9|5.4|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.4|1.9|
71837412|NCT04169373|143181559|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|10.9||||0.0035|TWO_SIDED|95.0|3.6|18.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||18.3|3.6|0.0035
71837413|NCT04169373|143181559|OTHER||Odds Ratio (OR)|2.7|||||TWO_SIDED|95.0|1.3|5.6|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||5.6|1.3|
71837414|NCT04169373|143181560|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.68|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.68|-1.60|<0.0001
71837415|NCT04169373|143181561|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-2.23|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.21|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.21|-3.26|<0.0001
71837416|NCT04169373|143181562|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-1.78|||<|0.0001|TWO_SIDED|95.0|-2.56|-1.0|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-1.00|-2.56|<0.0001
71892322|NCT01381094|143306449|SUPERIORITY||||||=|0.4502|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.4502
71892323|NCT01381094|143306449|SUPERIORITY||||||=|0.6967|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6967
71892324|NCT01381094|143306449|SUPERIORITY||||||=|0.7385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7385
71837417|NCT04169373|143181563|SUPERIORITY|To preserve the overall type I error rate at α = 0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|Response Rate Difference|22.8|||<|0.0001|TWO_SIDED|95.0|12.2|33.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.4|12.2|<0.0001
71837418|NCT04169373|143181563|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|1.6|4.0|||||Upadacitinib : Placebo|A post-hoc logistic regression adjusting for the main stratification factor of MRI and screening hsCRP status was conducted for the multiplicity-controlled binary endpoints assessed at Week 14.||4.0|1.6|
71892325|NCT01381094|143306449|SUPERIORITY||||||=|0.0176|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0176
71892326|NCT01381094|143306449|SUPERIORITY||||||=|0.0057|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0057
71892327|NCT01381094|143306449|SUPERIORITY||||||=|0.5551|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5551
71892328|NCT01381094|143306449|SUPERIORITY||||||=|0.0086|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0086
71892329|NCT01381094|143306449|SUPERIORITY||||||=|0.2385|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2385
71892330|NCT01381094|143306449|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0007
71671414|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|10.0|||<|0.0001|TWO_SIDED|95.0|3.8|26.6||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||26.6|3.8|<0.0001
71671415|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
71671416|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.3|0.0|<0.0001
71671417|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
71837419|NCT04169373|143181564|SUPERIORITY|To preserve the overall type I error rate at α=0.05 level, a multiple testing procedure was used to test the primary and multiplicity-controlled secondary endpoints. Testing began with the primary endpoint using two-sided α = 0.05; significance could be claimed for a lower ranked endpoint only if the previous endpoints in the sequence met the requirement of significance.|LS Mean Difference|-0.1||||0.1781|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|ANCOVA model including treatment and main stratification factor MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||0.05|-0.25|0.1781
71837420|NCT04169373|143181565|OTHER||LS Mean Difference|-0.7||||0.0193|TWO_SIDED|95.0|-1.3|-0.1|||Mixed-effect Model Repeated Measurement|MMRM model includes treatment, visit, treatment-by-visit interaction, main stratification factors MRI and screening hsCRP status, and Baseline value.|Treatment difference = Upadacitinib - Placebo|||-0.1|-1.3|0.0193
71837421|NCT04169373|143181566|SUPERIORITY||Response Rate Difference|20.1||||0.0003|TWO_SIDED|95.0|9.3|30.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.9|9.3|0.0003
71837422|NCT04169373|143181567|OTHER||LS Mean Difference|-1.13||||0.0206|TWO_SIDED|95.0|-2.08|-0.17||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model including treatment and main stratification factors MRI and hsCRP status as fixed factors and Baseline value as covariate.|Treatment difference = Upadacitinib - Placebo|||-0.17|-2.08|0.0206
71837423|NCT04169373|143181569|SUPERIORITY||Response Rate Difference|17.6||||0.0004|TWO_SIDED|95.0|7.9|27.3||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||27.3|7.9|0.0004
71837424|NCT04169373|143181570|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|13.2|30.6||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||30.6|13.2|<0.0001
71837425|NCT04169373|143181571|SUPERIORITY||Response Rate Difference|23.1|||<|0.0001|TWO_SIDED|95.0|12.4|33.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by main stratification factor of MRI and screening hsCRP level status.|Response Rate Difference = Upadacitinib - Placebo|||33.7|12.4|<0.0001
71671418|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.4||||0.0011|TWO_SIDED|95.0|0.2|0.8||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.8|0.2|0.0011
71837426|NCT01999075|143181572|SUPERIORITY||Mean Difference (Net)|1.9||||0.68|TWO_SIDED|95.0|-6.9|10.7||The a priori threshold for statistical significance was a two-sided p-value of 0.05.|ANCOVA||"The mean difference between the intervention and the control group in the change from baseline to 2 years was estimated.~Estimates presented here are based on multiple imputation of missing values."|||10.7|-6.9|0.68
71671419|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
71671420|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|2.6||||0.0718|TWO_SIDED|95.0|1.0|6.9||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||6.9|1.0|0.0718
71671421|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
71671422|NCT02861586|142860160|SUPERIORITY||Gemetric mean ratio|0.4||||0.0593|TWO_SIDED|95.0|0.1|1.0||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.0|0.1|0.0593
71837427|NCT01999075|143181576|SUPERIORITY||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|-1.92|2.18||||||Difference in change in peak cough flow (L/min) from baseline to 2 years, between conventional treatment and intervention group.||2.18|-1.92|
71837428|NCT01999075|143181577|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
71837429|NCT01999075|143181578|SUPERIORITY|||||||1|||||||Mixed Models Analysis|||||||1.00
71837430|NCT01999075|143181579|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
71837431|NCT05081583|143181582|OTHER||AUC ratio (geometric mean)|0.88|||||TWO_SIDED|90.0|0.82|0.96||||||The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.||0.96|0.82|
71837432|NCT05081583|143181583|OTHER|The predefined no effect range was 0.80-1.25; that is, if the geometric mean ratio lay outside this range, a pharmacokinetic interaction was evident.|Cmax ratio (geometric mean)|0.93|||||TWO_SIDED|90.0|0.85|1.01||||||||1.01|0.85|
71837433|NCT05081583|143181584|OTHER||Half-life ratio (geometric mean)|1.01|||||TWO_SIDED|90.0|0.93|1.07||||||||1.07|0.93|
71837434|NCT05081583|143181585|OTHER||Renal clearance ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.84|1.12||||||||1.12|0.84|
71837435|NCT05081583|143181586|OTHER||AUC ratio (geometric mean)|0.97|||||TWO_SIDED|90.0|0.81|1.15||||||||1.15|0.81|
71837436|NCT03675282|143181617|SUPERIORITY||Mean Difference (Final Values)|19.8||||0.66|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.66
71837437|NCT03675282|143181617|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.63|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.63
71837438|NCT03675282|143181617|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.99|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.99
71837439|NCT03675282|143181617|SUPERIORITY||Mean Difference (Final Values)|11.5||||0.67|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.67
71837440|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.625||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part I (Baseline vs. 24 months)||||0.40
71837441|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-1.453||||0.4|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part II (Baseline vs. 24 months)||||0.40
71837442|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-6.15||||0.04|TWO_SIDED|||||Parkinson Disease - Stage 1 UPDRS Part III (Baseline vs. 24 months)|paired t-test|||||||0.04
71837443|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.056||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 UPDRS Part IV (Baseline vs. 24 months)||||0.94
71837444|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.414||||0.53|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part I (Baseline vs. 24 months)||||0.53
71837445|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-1.779||||0.38|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part II (Baseline vs. 24 months)||||0.38
71671423|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|5.2|||<|0.0001|TWO_SIDED|95.0|2.6|10.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||10.4|2.6|<0.0001
71837446|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-3.59||||0.24|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part III (Baseline vs. 24 months)||||0.24
71837447|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.73|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 UPDRS Part IV (Baseline vs. 24 months)||||0.73
71837448|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-1.187||||0.16|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part I (Baseline vs. 24 months)||||0.16
71837449|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.154||||0.75|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part II (Baseline vs. 24 months)||||0.75
71837450|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.28|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part III (Baseline vs. 24 months)||||0.28
71837451|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.077||||0.85|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder UPDRS Part IV (Baseline vs. 24 months)||||0.85
71837452|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|0.204||||0.78|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part I (Baseline vs. 24 months)||||0.78
71837453|NCT03675282|143181618|SUPERIORITY||Mean Difference (Final Values)|-0.381||||0.03|TWO_SIDED||||||paired t-test|||Healthy Controls UPDRS Part IV (Baseline vs. 24 months)||||0.03
71837454|NCT03675282|143181619|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.3|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 1 (Baseline vs. 24 months)||||0.30
71837455|NCT03675282|143181619|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.94|TWO_SIDED||||||paired t-test|||Parkinson Disease - Stage 2 (Baseline vs. 24 months)||||0.94
71837456|NCT03675282|143181619|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.45|TWO_SIDED||||||paired t-test|||REM Sleep Behavior Disorder (Baseline vs. 24 months)||||0.45
71837457|NCT03675282|143181619|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8|TWO_SIDED||||||paired t-test|||Healthy Controls (Baseline vs. 24 months)||||0.80
71837458|NCT03056040|143181631|NON_INFERIORITY|A difference in percent change in LDH between the ravulizumab and eculizumab treatment groups at Day 183 along with a 2-sided 95% confidence interval (CI) was calculated. Noninferiority margin (NIM) was based on the upper bound of the 95% CI. NIM was 15%.|Treatment Difference|-9.21|||||TWO_SIDED|95.0|-18.84|0.42|||||Treatment difference was estimated for ravulizumab - eculizumab.|Adjusting for a possible 10% dropout rate, a minimum of 192 participants were estimated to provide 90% power to demonstrate noninferiority of ravulizumab to eculizumab.||0.42|-18.84|
71837459|NCT03056040|143181632|NON_INFERIORITY|NIM was based on the upper bound of the 95% CI. NIM was 20%.|Treatment Difference|-5.1|||||TWO_SIDED|95.0|-18.99|8.89|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with BTH was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||8.89|-18.99|
71837460|NCT03056040|143181633|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM margin was -3.|Treatment Difference|1.47|||||TWO_SIDED|95.0|-0.21|3.15|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.15|-0.21|
71837461|NCT03056040|143181634|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|5.5|||||TWO_SIDED|95.0|-4.27|15.68|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants achieving transfusion avoidance was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug||15.68|-4.27|
71837462|NCT03056040|143181635|NON_INFERIORITY|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|1.4|||||TWO_SIDED|95.0|-10.41|13.31|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with stabilized hemoglobin was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.||13.31|-10.41|
71756600|NCT00541658|143016771|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.563|||||TWO_SIDED|95.0|-1.045|-0.08|||ANOVA|Fixed effects for treatment, pooled center, anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.080|-1.045|
71756601|NCT00541658|143016772|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.327|||||TWO_SIDED|95.0|-0.793|0.138|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.138|-0.793|
71756602|NCT00541658|143016772|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.537|||||TWO_SIDED|95.0|-1.0|-0.074|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.074|-1.000|
71756603|NCT00541658|143016773|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.578|||||TWO_SIDED|95.0|-1.189|0.032|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.032|-1.189|
71756604|NCT00541658|143016773|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.799|||||TWO_SIDED|95.0|-1.403|-0.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.194|-1.403|
71837463|NCT04650087|143181640|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.44|1.95||||||||1.95|0.44|
71837464|NCT04650087|143181641|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.83|1.31||||||||1.31|0.83|
71837465|NCT04650087|143181642|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.78|1.24||||||||1.24|0.78|
71756605|NCT00541658|143016774|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.555|||||TWO_SIDED|95.0|-1.128|0.018|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.018|-1.128|
71837466|NCT04650087|143181643|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.44|1.74||||||||1.74|0.44|
71671424|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|2.2||||0.2005|TWO_SIDED|95.0|0.8|5.7||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||5.7|0.8|0.2005
71671425|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|35.0|||<|0.0001|TWO_SIDED|95.0|13.1|93.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||93.1|13.1|<0.0001
71671426|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
71671427|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.0|||<|0.0001|TWO_SIDED|0.0|0.0|0.1|||ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.1|0.0|<0.0001
71756606|NCT00541658|143016774|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.616|||||TWO_SIDED|95.0|-1.185|-0.046|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.046|-1.185|
71756607|NCT00541658|143016775|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.249|||||TWO_SIDED|95.0|-0.86|0.363|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.363|-0.860|
71756608|NCT00541658|143016775|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||TWO_SIDED|95.0|-0.871|0.342|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.342|-0.871|
71756609|NCT00541658|143016776|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.557|||||TWO_SIDED|95.0|-1.185|0.071|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.071|-1.185|
71756610|NCT00541658|143016776|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.522|||||TWO_SIDED|95.0|-1.149|0.105|||ANOVA||LS Mean Difference is 5 mg daily minus weekly treatment.|||0.105|-1.149|
71756611|NCT00541658|143016777|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.546|||||TWO_SIDED|95.0|-1.17|0.078|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.078|-1.170|
71788720|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.26||||0.1918|TWO_SIDED|95.0|-0.32|0.84|||MMRM||General health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.84|-0.32|0.1918
71788721|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.45||||0.0677|TWO_SIDED|95.0|-0.14|1.04|||MMRM||General health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.04|-0.14|0.0677
71788722|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.33||||0.8386|TWO_SIDED|95.0|-0.98|0.32|||MMRM||General health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.32|-0.98|0.8386
71837467|NCT04650087|143181644|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.12||||||||2.12|0.58|
71837468|NCT04650087|143181645|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.29|3.42||||||||3.42|0.29|
71837469|NCT04650087|143181646|SUPERIORITY||Risk Ratio (RR)|0.33|||||TWO_SIDED|95.0|0.03|3.18||||||||3.18|0.03|
71837470|NCT04650087|143181647|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.34|2.28||||||||2.28|0.34|
71837471|NCT05229146|143181695|SUPERIORITY|||||||0.191||||||No adjustment for multiple comparisons.|t-test, 1 sided|t-statistic = .913, df = 10||One-sided paired-samples t-test comparing baseline to responses immediately following the intervention (approximately one week after baseline).||||.191
71837472|NCT05229146|143181695|SUPERIORITY|||||||0.043||||||Not adjusted for multiple comparisons.|t-test, 1 sided|t-statistic = 1.92, df = 9||One-sided paired-samples t-test comparing baseline to responses at two week follow-up (approximately four weeks after baseline).||||.043
71837473|NCT05229146|143181696|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.319|TWO_SIDED|||||No adjustments were made. DF = 15.|t-test, 2 sided|||Comparison is between future orientation subscale pre- and post-subscale scores.||||.319
71837474|NCT05229146|143181696|SUPERIORITY||Mean Difference (Final Values)|-0.711||||0.488|TWO_SIDED||||||t-test, 2 sided|No adjustments were made. DF = 15.||Comparison between immediate-orientation subscales.||||.488
71837475|NCT05229146|143181697|SUPERIORITY||Mean Difference (Final Values)|0.438||||0.34|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a paired-samples one-sided t-test comparing positive parenting before the intervention to after the intervention.||||.34
71837476|NCT05229146|143181697|SUPERIORITY||Mean Difference (Final Values)|-0.363||||0.362|ONE_SIDED||||||t-test, 1 sided|No adjustments were made. DF = 10.||Performed a one-sided paired-samples t-test to compare negative parenting before and after the intervention.||||.362
71837477|NCT05229146|143181698|SUPERIORITY||Mean Difference (Final Values)|-3.77|||<|0.001|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15||Used a one-sided paired samples t-test to examine changes in the parental involvement subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||<.001
71837478|NCT05229146|143181698|SUPERIORITY||Median Difference (Final Values)|-1.14||||0.137|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the positive parenting subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.137
71671428|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.4||||0.1138|TWO_SIDED|95.0|0.2|1.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||1.1|0.2|0.1138
71671429|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|6.7|||<|0.0001|TWO_SIDED|95.0|2.5|18.1||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||18.1|2.5|<0.0001
71837479|NCT05229146|143181698|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.018|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the inconsistent discipline subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.018
71837480|NCT05229146|143181698|SUPERIORITY||Mean Difference (Final Values)|2.39||||0.015|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15.||Used a one-sided paired samples t-test to examine changes in the use of corporal punishment subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.015
71837481|NCT05229146|143181698|SUPERIORITY||Mean Difference (Final Values)|2.23||||0.021|ONE_SIDED||||||t-test, 1 sided|||Used a one-sided paired samples t-test to examine changes in the poor parental monitoring/supervision subscale from pre-intervention to post-intervention (approximately 4 weeks later).||||.021
71837482|NCT05229146|143181699|SUPERIORITY||Mean Difference (Final Values)|0.878||||0.197|ONE_SIDED||||||t-test, 1 sided|No adjustments; DF = 15||Used a one-sided paired-samples t-test to examine changes in emotion regulation subscale from pre-intervention to post-intervention.||||.197
71837483|NCT05229146|143181699|SUPERIORITY||Mean Difference (Final Values)|0.857||||0.203|ONE_SIDED||||||t-test, 1 sided|No adjustments, DF = 15.||Used a one-sided paired-samples t-test to examine changes in lability/negativity subscale from pre-intervention to post-intervention.||||.203
71837484|NCT03891667|143181740|SUPERIORITY||Odds Ratio (OR)|4.0|||||TWO_SIDED|95.0|0.21|75.66||||||||75.66|.21|
71837485|NCT03891667|143181741|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.05|9.47||||||||9.47|0.05|
71837486|NCT04055090|143181762|OTHER||Least Square Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.438||0.046|TWO_SIDED|95.0|-1.76|-0.02|||Mixed Models Analysis|Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects|Mixed-effects Model for Repeated Measures with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. The Baseline average 24-hour pain score was included as a covariate.|||-0.02|-1.76|0.0460
71837487|NCT04055090|143181764|OTHER|||||||0.219|||||||Cochran-Mantel-Haenszel|||||||0.2190
71837488|NCT04055090|143181765|OTHER||Least-Squares Mean Difference|-1.48||||0.0155|TWO_SIDED|95.0|-2.67|-0.29|||Mixed Models Analysis||Mixed-effects Model for Repeated Measures (MMRM) with treatment, visit, treatment-by-visit, and use of gabapentin/pregabalin as main fixed effects. Baseline average 24-hour pain score is included as a covariate.|||-0.29|-2.67|0.0155
71837489|NCT05071807|143181766|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-1.17|1.33|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and BMI (kg/m2)||To detect a 1.2 percentage point (standard deviation 2.4; effect size 0.5) between-group difference in the change in FMD with 80% power (α=0.05), it was estimated that a sample size of 128 participants was needed (64 per group)||1.33|-1.17|
71837490|NCT05071807|143181767|SUPERIORITY||Mean Difference (Net)|-7.2|||||TWO_SIDED|95.0|-12.3|-2.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.1|-12.3|
71837491|NCT05071807|143181768|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-0.8|2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||2.9|-0.8|
71837492|NCT05071807|143181769|SUPERIORITY||Mean Difference (Net)|-16.4|||||TWO_SIDED|95.0|-30.0|-2.9|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-2.9|-30.0|
71837493|NCT05071807|143181770|SUPERIORITY||Mean Difference (Net)|-75.3|||||TWO_SIDED|95.0|-144.0|-6.93|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Total LDL particle mean difference||-6.93|-144|
71756612|NCT00541658|143016777|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.579|||||TWO_SIDED|95.0|-1.199|0.042|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||0.042|-1.199|
71788723|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.29||||0.7928|TWO_SIDED|95.0|-0.99|0.41|||MMRM||General health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.41|-0.99|0.7928
71892331|NCT01381094|143306449|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0002
71892332|NCT01381094|143306449|SUPERIORITY||||||=|0.8895|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8895
71892333|NCT01381094|143306449|SUPERIORITY||||||=|0.0127|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0127
71892334|NCT01381094|143306449|SUPERIORITY||||||=|0.0076|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0076
71671430|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
71788724|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.04||||0.4537|TWO_SIDED|95.0|-0.63|0.71|||MMRM||Mental health,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.71|-0.63|0.4537
71788725|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.05||||0.5548|TWO_SIDED|95.0|-0.74|0.65|||MMRM||Mental health,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.65|-0.74|0.5548
71788726|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.13||||0.3626|TWO_SIDED|95.0|-0.61|0.88|||MMRM||Mental health,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.88|-0.61|0.3626
71788727|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.81||||0.9721|TWO_SIDED|95.0|-1.64|0.02|||MMRM||Mental health,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-1.64|0.9721
71788728|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.09||||0.5789|TWO_SIDED|95.0|-0.96|0.78|||MMRM||Role-emotional,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.78|-0.96|0.5789
71788729|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.37||||0.2054|TWO_SIDED|95.0|-0.51|1.24|||MMRM||Role-emotional,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.51|0.2054
71788730|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.05||||0.5389|TWO_SIDED|95.0|-0.98|0.89|||MMRM||Role-emotional,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||0.89|-0.98|0.5389
71788731|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.09||||0.4289|TWO_SIDED|95.0|-0.91|1.09|||MMRM||Role-emotional,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions.|||1.09|-0.91|0.4289
71788732|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.08||||0.4096|TWO_SIDED|95.0|-0.6|0.75|||MMRM||Role-physical,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.75|-0.60|0.4096
71788733|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.4||||0.1196|TWO_SIDED|95.0|-0.27|1.07|||MMRM||Role-physical,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.07|-0.27|0.1196
71788734|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.3||||0.2093|TWO_SIDED|95.0|-0.42|1.01|||MMRM||Role-physical,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.01|-0.42|0.2093
71788735|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.39||||0.1674|TWO_SIDED|95.0|-0.4|1.19|||MMRM||Role-physical,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region,Baseline value and Baseline value by time and treatment by time interactions|||1.19|-0.40|0.1674
71756613|NCT00541658|143016778|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.095|||||TWO_SIDED|95.0|-1.861|-0.329|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.329|-1.861|
71756614|NCT00541658|143016778|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.19|||||TWO_SIDED|95.0|-1.948|-0.432|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.432|-1.948|
71756615|NCT00541658|143016779|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.919|||||TWO_SIDED|95.0|-1.655|-0.184|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.184|-1.655|
71756616|NCT00541658|143016779|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.056|||||TWO_SIDED|95.0|-1.787|-0.326|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||-0.326|-1.787|
71756617|NCT00541658|143016780|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.771|||||TWO_SIDED|95.0|-0.885|8.427|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.427|-0.885|
71837494|NCT05071807|143181770|SUPERIORITY||Mean Difference (Net)|-27.9|||||TWO_SIDED|95.0|-69.3|13.4|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||For Large LDL particle subclass||13.4|-69.3|
71837495|NCT05071807|143181771|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.56|0.75|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||Results for total HDL particle count||0.75|-0.56|
71756618|NCT00541658|143016780|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.826|||||TWO_SIDED|95.0|-1.819|7.471|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.471|-1.819|
71756619|NCT00541658|143016781|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.63|||||TWO_SIDED|95.0|-2.171|7.431|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||7.431|-2.171|
71756620|NCT00541658|143016781|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.617|||||TWO_SIDED|95.0|-0.152|9.386|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.386|-0.152|
71788736|NCT02879305|143074900|SUPERIORITY||LS mean difference|-0.14||||0.6585|TWO_SIDED|95.0|-0.82|0.54|||MMRM||Social fun, Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.54|-0.82|0.6585
71788737|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.69||||0.0293|TWO_SIDED|95.0|-0.03|1.4|||MMRM||Social fun, Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.40|-0.03|0.0293
71788738|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.33||||0.2057|TWO_SIDED|95.0|-0.45|1.11|||MMRM||Social fun, Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.11|-0.45|0.2057
71837496|NCT05071807|143181771|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.75|0.8||||Adjusted for baseline value, age, sex, and BMI||Results for Small HDL particles||0.80|-0.75|
71671431|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.4|0.1|<0.0001
71788739|NCT02879305|143074900|SUPERIORITY||LS mean difference|0.02||||0.4849|TWO_SIDED|95.0|-0.86|0.9|||MMRM||Social fun, Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.90|-0.86|0.4849
71788740|NCT02879305|143074901|SUPERIORITY||LS mean difference|0.03||||0.4621|TWO_SIDED|95.0|-0.58|0.64|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.64|-0.58|0.4621
71788741|NCT02879305|143074901|SUPERIORITY||LS mean difference|0.35||||0.1439|TWO_SIDED|95.0|-0.29|0.98|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.98|-0.29|0.1439
71788742|NCT02879305|143074901|SUPERIORITY||LS mean difference|0.24||||0.2392|TWO_SIDED|95.0|-0.43|0.92|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.92|-0.43|0.2392
71837497|NCT05071807|143181771|SUPERIORITY||Mean Difference (Net)|-0.33|||||TWO_SIDED|95.0|-0.85|0.19|||Regression, Linear|Adjusted for baseline value, age, sex, and BMI||Results for Medium HDL||0.19|-0.85|
71837498|NCT05071807|143181772|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-3.09|3.13|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results from brachial systolic blood pressure are reported below||3.13|-3.09|
71837499|NCT05071807|143181772|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.67|2.07|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for Brachial Diastolic Blood pressure||2.07|-1.67|
71837500|NCT05071807|143181773|SUPERIORITY||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-3.24|2.28|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central systolic blood pressure||2.28|-3.24|
71837501|NCT05071807|143181773|SUPERIORITY||Median Difference (Net)|0.21|||||TWO_SIDED|95.0|-1.69|2.1|||Regression, Linear|Adjusted for baseline value, age, sex, BMI||Results for central diastolic blood pressure||2.10|-1.69|
71837502|NCT05071807|143181774|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.26|0.24|||Regression, Linear|were adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.24|-0.26|
71837503|NCT05071807|143181775|SUPERIORITY||Mean Difference (Net)|-1.65|||||TWO_SIDED|95.0|-4.25|0.95|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||0.95|-4.25|
71837504|NCT05071807|143181776|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.6|3.0|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||3.0|-0.6|
71837505|NCT05071807|143181777|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-2.3|1.6|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||1.6|-2.3|
71837506|NCT05071807|143181778|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.1|0.0|
71837507|NCT05071807|143181779|SUPERIORITY||Mean Difference (Net)|9.4|||||TWO_SIDED|95.0|5.0|13.7||When a significant group by time point interaction was detected, post hoc testing was conducted and the Tukey-Kramer method was used to adjust for multiple comparisons.|Mixed Models Analysis|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||13.7|5.0|
71837508|NCT05071807|143181780|SUPERIORITY||Median Difference (Net)|-8.1|||||TWO_SIDED|95.0|-14.5|-1.7|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||||-1.7|-14.5|
71837509|NCT05071807|143181781|SUPERIORITY||Mean Difference (Net)|-25.5|||||TWO_SIDED|95.0|-98.6|47.5|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2)||Results for medium subclass; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||47.5|-98.6|
71837510|NCT05071807|143181781|SUPERIORITY||Mean Difference (Net)|1.86|||||TWO_SIDED|95.0|-91.8|95.5|||Regression, Linear|adjustment for the baseline value, age (years), sex (male or female) and body mass index (BMI) (kg/m2)||Results for Small LDL particles; Measure Description: LDL particle size classifications are as follows: 22-25.5 nm is small, 25.6-26.5 nm medium, and 26.6-28.5 nm large. Typically, smaller LDL is associated with increased cardiovascular risk compared to larger.||95.5|-91.8|
71837511|NCT05071807|143181782|SUPERIORITY||Mean Difference (Net)|0.35|||||TWO_SIDED|95.0|0.07|0.63|||Regression, Linear|adjusted for outcome baseline value, age (years), sex (male or female) and baseline BMI (kg/m2).||||0.63|0.07|
71837512|NCT00667251|143181819|OTHER||Hazard Ratio (HR)|1.367||||0.001|TWO_SIDED|95.0|1.133|1.648|||Log Rank|||PFS at the time of Primary Analysis (IIT population)||1.648|1.133|0.0010
71837513|NCT00667251|143181819|OTHER||Hazard Ratio (HR)|1.484||||0.0002|TWO_SIDED|95.0|1.204|1.829|||Log Rank|||PFS at the time of Primary Analysis (Central HER2+ population)||1.829|1.204|0.0002
71837514|NCT00667251|143181820|OTHER||Hazard Ratio (HR)|1.3722|||||TWO_SIDED|95.0|1.1466|1.6422|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (IIT population)||1.6422|1.1466|
71837515|NCT00667251|143181820|OTHER||Hazard Ratio (HR)|1.4968|||||TWO_SIDED|95.0|1.2251|1.8288|||||Stratified HR for LTax/L versus TTax/T|PFS at the time of Final Analysis (Central HER2+ population)||1.8288|1.2251|
71837516|NCT00667251|143181821|OTHER||Hazard Ratio (HR)|1.3786|||||TWO_SIDED|95.0|1.0246|1.8549|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (IIT population)||1.8549|1.0246|
71837517|NCT00667251|143181822|OTHER||Hazard Ratio (HR)|1.5818|||||TWO_SIDED|95.0|1.1181|2.2379|||||Stratified HR for LTax/L versus TTax/T|Overall Survival (OS) (Central HER2+ population)||2.2379|1.1181|
71837518|NCT00667251|143181825|OTHER||Hazard Ratio (HR)|1.0916|||||TWO_SIDED|95.0|0.7271|1.6389|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (IIT population)||1.6389|0.7271|
71671432|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|16.0|||<|0.0001|TWO_SIDED|95.0|4.9|52.4||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||52.4|4.9|<0.0001
71671433|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
71671434|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|0.1|||<|0.0001|TWO_SIDED|95.0|0.0|0.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||0.2|0.0|<0.0001
71671435|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
71671436|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.3||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.3|0.3|1.0000
71671437|NCT02861586|142860160|SUPERIORITY||Geometric mean ratio|1.0||||1|TWO_SIDED|95.0|0.3|3.2||Pairwise comparisons were adjusted for multiple tests according to Tukey-Kramer. The threshold for significance was 0.05.|ANOVA|Analysis of variance was conducted with treatment group as a fixed factor.||||3.2|0.3|1.0000
71671438|NCT02861586|142860169|SUPERIORITY||Geometric mean ratio|0.9||||0.9775|TWO_SIDED|95.0|0.4|2.0|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.0|0.4|0.9775
71788743|NCT02879305|143074901|SUPERIORITY||LS mean difference|-0.15||||0.6545|TWO_SIDED|95.0|-0.9|0.6|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.60|-0.90|0.6545
71671439|NCT02861586|142860169|SUPERIORITY||Geometric mean ratio|1.3||||0.8366|TWO_SIDED|95.0|0.6|3.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.1|0.6|0.8366
71788744|NCT02879305|143074902|SUPERIORITY||LS mean difference|0.64||||0.029|TWO_SIDED|95.0|-0.02|1.31|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.31|-0.02|0.0290
71788745|NCT02879305|143074902|SUPERIORITY||LS mean difference|0.56||||0.0509|TWO_SIDED|95.0|-0.11|1.24|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.24|-0.11|0.0509
71788746|NCT02879305|143074902|SUPERIORITY||LS mean difference|0.77||||0.0237|TWO_SIDED|95.0|0.01|1.53|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.53|0.01|0.0237
71788747|NCT02879305|143074902|SUPERIORITY||LS mean difference|0.58||||0.0828|TWO_SIDED|95.0|-0.24|1.39|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||1.39|-0.24|0.0828
71837519|NCT00667251|143181826|OTHER||Hazard Ratio (HR)|1.0951|||||TWO_SIDED|95.0|0.7144|1.6787|||||Stratified HR for LTax/L versus TTax/T|Time to Central Nervous System (CNS) metastasis (Central HER2+ population)||1.6787|0.7144|
71837520|NCT00667251|143181831|OTHER||Hazard Ratio (HR)|1.0091|||||TWO_SIDED|95.0|0.809|1.2586|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (IIT population)||1.2586|0.8090|
71837521|NCT00667251|143181832|OTHER||Hazard Ratio (HR)|0.9573|||||TWO_SIDED|95.0|0.7544|1.2148|||||Stratified HR for LTax/L versus TTax/T|Time to Response (TTR) (Central HER2+ population)||1.2148|0.7544|
71837522|NCT00667251|143181833|OTHER||Hazard Ratio (HR)|1.4866|||||TWO_SIDED|95.0|1.1479|1.9251|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (IIT population)||1.9251|1.1479|
71671440|NCT02861586|142860169|SUPERIORITY||Geometric mean ratio|1.5||||0.5625|TWO_SIDED|95.0|0.7|3.6|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.6|0.7|0.5625
71671441|NCT02861586|142860169|SUPERIORITY||Geometric mean ratio|1.5||||0.5924|TWO_SIDED|95.0|0.6|3.5|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||3.5|0.6|0.5924
71788748|NCT02879305|143074903|SUPERIORITY||LS mean difference|0.0003||||0.4939|TWO_SIDED|95.0|-0.0326|0.0331|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0331|-0.0326|0.4939
71788749|NCT02879305|143074904|SUPERIORITY||LS mean difference|-1.8||||0.9292|TWO_SIDED|95.0|-4.2|0.6|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.6|-4.2|0.9292
71788750|NCT02879305|143074905|SUPERIORITY||LS mean difference|-0.06||||0.0428|TWO_SIDED|95.0|-0.13|0.01|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.01|-0.13|0.0428
71788751|NCT02879305|143074905|SUPERIORITY||LS mean difference|-0.04||||0.1155|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1155
71788752|NCT02879305|143074905|SUPERIORITY||LS mean difference|-0.04||||0.1426|TWO_SIDED|95.0|-0.12|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.12|0.1426
71671442|NCT02861586|142860169|SUPERIORITY||Geometric mean ratio|1.8||||0.3122|TWO_SIDED|95.0|0.8|4.1|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||4.1|0.8|0.3122
71756621|NCT00541658|143016782|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.04|||||TWO_SIDED|95.0|0.091|9.989|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.989|0.091|
71756622|NCT00541658|143016782|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.64|||||TWO_SIDED|95.0|-0.293|9.574|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.574|-0.293|
71756623|NCT00541658|143016783|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.372|||||TWO_SIDED|95.0|1.329|11.414|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.414|1.329|
71756624|NCT00541658|143016783|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.403|||||TWO_SIDED|95.0|-0.619|9.425|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.425|-0.619|
71756625|NCT00541658|143016784|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.739|||||TWO_SIDED|95.0|-0.793|10.271|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.271|-0.793|
71756626|NCT00541658|143016784|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.999|||||TWO_SIDED|95.0|-1.518|9.515|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.515|-1.518|
71756627|NCT00541658|143016785|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.817|||||TWO_SIDED|95.0|-0.693|10.327|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.327|-0.693|
71756628|NCT00541658|143016785|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.192|||||TWO_SIDED|95.0|-2.295|8.68|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.680|-2.295|
71756629|NCT00541658|143016786|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.45|||||TWO_SIDED|95.0|-0.26|9.16|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.160|-0.260|
71671443|NCT02861586|142860169|SUPERIORITY||Geometric mean ratio|1.2||||0.9665|TWO_SIDED|95.0|0.5|2.8|||ANOVA|Analysis of variance was performed with baseline measles titer group as a fixed factor.||||2.8|0.5|0.9665
71788753|NCT02879305|143074905|SUPERIORITY||LS mean difference|-0.05||||0.1152|TWO_SIDED|95.0|-0.13|0.03|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented, with factors for treatment, time, dialysis type, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.13|0.1152
71788754|NCT02068443|143074909|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.821|-0.48|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin alone (Metformin QD - Alogliptin alone).|||-0.480|-0.821|
71788755|NCT02068443|143074909|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of Alogliptin + Metformin Hydrochloride QD to Alogliptin + Metformin Hydrochloride BID.|LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.069|||TWO_SIDED|95.0|-0.026|0.247|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin + Metformin Hydrochloride BID (Metformin QD - Metformin BID).|||0.247|-0.026|
71788756|NCT01986855|143074921|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.807|TWO_SIDED|95.0|-0.23|0.18||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.18|-0.23|0.807
71788757|NCT01986855|143074921|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.15||||0.155|TWO_SIDED|95.0|-0.35|0.06||The cLDA model included fixed effects for treatment, time, eGFR stratum (\<45 or ≥45 mL/min/1.73m\^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.06|-0.35|0.155
71788758|NCT01986855|143074922|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.6|||||TWO_SIDED|95.0|-4.8|12.1|||||Miettinen \& Nurminen Method|||12.1|-4.8|
71788759|NCT01986855|143074922|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-7.0|||||TWO_SIDED|95.0|-16.3|2.3|||||Miettinen \& Nurminen Method|||2.3|-16.3|
71788760|NCT01986855|143074923|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|3.0|||||TWO_SIDED|95.0|-2.7|9.0|||||Miettinen \& Nurminen Method|||9.0|-2.7|
71788761|NCT01986855|143074923|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-1.3|||||TWO_SIDED|95.0|-6.5|3.7|||||Miettinen \& Nurminen Method|||3.7|-6.5|
71788762|NCT01986855|143074924|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.03||||0.828|TWO_SIDED|95.0|-0.28|0.23||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.23|-0.28|0.828
71788763|NCT01986855|143074924|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.09||||0.496|TWO_SIDED|95.0|-0.35|0.17||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.17|-0.35|0.496
71671444|NCT00803790|142860182|SUPERIORITY_OR_OTHER_LEGACY||least square mean ratio|1.01|||||TWO_SIDED|90.0|0.92|1.11||||||||1.11|0.92|
71788764|NCT01986855|143074925|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||<|0.001|TWO_SIDED|95.0|-2.57|-0.96||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-0.96|-2.57|<0.001
71788765|NCT01986855|143074925|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.84|||<|0.001|TWO_SIDED|95.0|-2.66|-1.02||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-1.02|-2.66|<0.001
71788766|NCT01986855|143074926|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.42||||0.451|TWO_SIDED|95.0|-5.13|2.29||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||2.29|-5.13|0.451
71788767|NCT01986855|143074926|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.46||||0.072|TWO_SIDED|95.0|-7.24|0.31||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||0.31|-7.24|0.072
71788768|NCT01986855|143074927|SUPERIORITY_OR_OTHER||Difference in the least squares means|-6.81||||0.291|TWO_SIDED|96.0|-19.47|5.85||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.85|-19.47|0.291
71788769|NCT01986855|143074927|SUPERIORITY_OR_OTHER||Difference in the least squares means|-15.51||||0.019|TWO_SIDED|95.0|-28.5|-2.53||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis|||||-2.53|-28.50|0.019
71671445|NCT00803790|142860183|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||Least squares mean ratio for AUC 0-80 hr for vitamin D following administration of combination tablet and vitamin D alone. No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis.||1.00|0.89|
71788770|NCT01986855|143074928|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.16||||0.713|TWO_SIDED|95.0|0.53|2.56||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.56|0.53|0.713
71788771|NCT01986855|143074928|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.06||||0.89|TWO_SIDED|95.0|0.44|2.55||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model|||||2.55|0.44|0.890
71788772|NCT00710710|143074933|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
71788773|NCT00710710|143074933|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
71788774|NCT00710710|143074933|OTHER||Maximum likelihood estimation|0.0233||||0.7021|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.7021
71837523|NCT00667251|143181834|OTHER||Hazard Ratio (HR)|1.5594|||||TWO_SIDED|95.0|1.1767|2.0666|||||Stratified HR for LTax/L versus TTax/T|Duration of Response (DoR) (Central HER2+ population)||2.0666|1.1767|
71837524|NCT02995434|143181867|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model.|Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.86|-0.3|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|Null hypothesis: There is no difference between the reported daily pain experiences of participants during, or after exposure to VR immersive environments, overall and within four different VR immersive environments, compared to the equivalent applications experienced on a 2D computer screen.||-0.30|-3.86|
71788775|NCT00710710|143074933|OTHER||Maximum likelihood estimation|0.0233||||0.9156|TWO_SIDED|95.0|0.0006|0.1229||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.1229|0.0006|0.9156
71788776|NCT00710710|143074936|OTHER||Hazard Ratio (HR)|1.22||||0.38|TWO_SIDED|95.0|0.78|1.91|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.91|0.78|0.38
71788777|NCT00710710|143074937|OTHER||Hazard Ratio (HR)|1.1||||0.69|TWO_SIDED|95.0|0.68|1.78|||Regression, Cox||if HR is below 1, then 60mg BI 2536 IV on day 1-3 is better.|||1.78|0.68|0.69
71788778|NCT00710710|143074938|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
71788779|NCT00710710|143074938|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
71788780|NCT00710710|143074938|OTHER||Maximum likelihood estimation|0.0||||0.9161|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.056, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9161
71788781|NCT00710710|143074938|OTHER||Maximum likelihood estimation|0.0||||0.9842|TWO_SIDED|95.0|0.0|0.0822||p0 = 0.092, one sided exact binomial test with a 2.5% significance level|Exact binomial test|||Confirmed objective response, comparison with historical controls (Gemcitabine)||0.0822|0.0000|0.9842
71788782|NCT00715078|143074945|NON_INFERIORITY_OR_EQUIVALENCE|Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|ratio of geometric means (GeoMean)|1.046||||0.5019|TWO_SIDED|90.0|0.936|1.168|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.168|0.936|0.5019
71837525|NCT02995434|143181867|EQUIVALENCE|As reliable estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model|Mean Difference (Net)|0.53|||||TWO_SIDED|95.0|-1.24|2.37|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.37|-1.24|
71788783|NCT00715078|143074945|NON_INFERIORITY_OR_EQUIVALENCE|Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is \>0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of \<20% in upregulation ratios may not be clinically significant.|the ratio of geometric means|0.907||||0.1443|TWO_SIDED|90.0|0.813|1.013|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).||1.013|0.813|0.1443
71788784|NCT02259582|143074991|SUPERIORITY|Based on RECIST v1.1. Response outcomes from an assessment done anytime less than Day 35 were considered as not evaluable unless the response assessment was progress disease.|Hazard Ratio (HR)|0.04|||=|0.0401|TWO_SIDED|95.0|0.013|0.095|||Log Rank|||The Kaplan-Meier method was used to estimate both the survival curves and the median survival time. The 95% confidence interval (CI) for the median survival time was calculated. A p-value for treatment effect was generated using a stratified Cox proportional hazards model.||.095|.013|=0.0401
71788785|NCT02436889|143075054|SUPERIORITY|||||||0.949|||||||ANCOVA|||||||0.949
71788786|NCT02436889|143075055|SUPERIORITY||Mean Difference (Final Values)|3.11||||0.2415|TWO_SIDED|95.0|-2.09|8.31|||ANCOVA|change from baseline, adjusted for baseline value||||8.31|-2.09|0.2415
71788787|NCT02436889|143075056|SUPERIORITY||Mean Difference (Final Values)|-12.01||||0.0001|TWO_SIDED|95.0|-18.16|-5.87|||ANCOVA|||||-5.87|-18.16|0.0001
71788788|NCT02436889|143075057|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.1956|TWO_SIDED|95.0|-1.59|0.33|||ANCOVA|||||0.33|-1.59|0.1956
71788789|NCT02436889|143075058|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.0168|TWO_SIDED|95.0|0.34|3.4|||ANCOVA|||||3.40|0.34|0.0168
71788790|NCT02436889|143075059|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.0101|TWO_SIDED|95.0|0.5|3.71|||ANCOVA|||||3.71|0.50|0.0101
71788791|NCT01084174|143075063|OTHER|||||||0.003|||||||Regression, Linear|Analyzed by linear regression models using generalized estimating equations to account for repeated measures over time with robust standard errors||||||.003
71788792|NCT01084174|143075064|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
71788793|NCT01084174|143075065|OTHER||||||<|0.001|||||||Regression, Linear|||||||<.001
71788794|NCT01084174|143075066|OTHER|||||||0.4|||||||Regression, Linear|||||||0.40
71788795|NCT01084174|143075067|OTHER|||||||0.07|||||||Regression, Linear|||||||.07
71788796|NCT01084174|143075068|OTHER|||||||0.007|||||||Regression, Linear|||||||.007
71671446|NCT00803790|142860184|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Ratio|0.94|||||TWO_SIDED|90.0|0.88|1.0||||||"Least squares mean ratio for Cmax for vitamin D following administration of combination tablet and vitamin D alone.~No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis."||1.00|0.88|
71671447|NCT05161481|142860190|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-8.4|STANDARD_ERROR_OF_MEAN|8.9|||TWO_SIDED|95.0|-26.25|9.45||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||9.45|-26.25|
71671448|NCT05161481|142860190|OTHER|"The adjusted mean values for percentage change at Week 24 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|-14.18|STANDARD_ERROR_OF_MEAN|9.93|||TWO_SIDED|95.0|-34.09|5.72||||||Model includes baseline HVPG as linear covariate and treatment and use of NSBBs or carvedilol as fixed effects, treatment by visit interaction and baseline HVPG by visit interaction. The following covariance structure has been used to fit the mixed model: Unstructured.||5.72|-34.09|
71671449|NCT05161481|142860191|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|3.51|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|-8.94|15.96||||||The analysis of covariance (ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||15.96|-8.94|
71671450|NCT05161481|142860191|OTHER|"The adjusted mean values for percentage change at Week 8 are derived for each group using the MMRM. The mean difference for the Comparison vs Placebo, is the adjusted mean of the treatment group subtracted from the adjusted mean of the placebo group."|Difference of adjusted means|2.69|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-10.94|16.33||||||ANCOVA) model includes baseline hepatic venous pressure gradient (HVPG) as a linear covariate, with treatment and use of non-selective beta-blockers (NSBBs) or carvedilol as fixed effects. All intercurrent events (ICEs) will be handled using the treatment policy for the primary objective as a sensitivity analysis. That is, all data collected after the intercurrent events will be included in the analysis.||16.33|-10.94|
71788797|NCT01034462|143075069|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.095||||0.0051|TWO_SIDED|95.0|-5.256|-0.935|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.935|-5.256|0.0051
71788798|NCT01034462|143075070|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.632||||0.001|TWO_SIDED|95.0|-4.193|-1.07|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.070|-4.193|0.0010
71837526|NCT02995434|143181868|EQUIVALENCE|See section for primary outcome.|Mean Difference (Net)|1.08|||||TWO_SIDED|95.0|-1.59|3.95|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.95|-1.59|
71671451|NCT03985800|142860199|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.26||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.26 with two degrees of freedom.||Null hypothesis: The trajectory of IBD complexity score does not differ by treatment group.||||0.53
71671452|NCT03985800|142860199|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.14||||0.57||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.14 with two degrees of freedom.||Aim 2b., moderation by age. Null hypothesis: Age does not moderate the trajectory of complexity score by treatment group.||||0.57
71671453|NCT03985800|142860199|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.08||||0.96||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 0.08 with two degrees of freedom.||Aim 2b., moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of complexity score by treatment group.||||0.96
71788799|NCT02618434|143075086|SUPERIORITY||Median Difference (Net)|-0.56||||0.9383|TWO_SIDED|95.0|-8.96|7.84|||Wilcoxon (Mann-Whitney)|||||7.84|-8.96|0.9383
71788800|NCT02618434|143075087|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.0979|TWO_SIDED|95.0|-0.33|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.33|0.0979
71788801|NCT02618434|143075087|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.50|0.0502
71837527|NCT02995434|143181868|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.16|||||TWO_SIDED|95.0|-0.55|5.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.08|-0.55|
71837528|NCT02995434|143181868|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-2.64|3.42|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||3.42|-2.64|
71837529|NCT02995434|143181868|EQUIVALENCE|See section on primary outcome|Mean Difference (Net)|2.56|||||TWO_SIDED|95.0|-0.08|5.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.48|-0.08|
71837530|NCT02995434|143181869|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.37|||||TWO_SIDED|95.0|-0.71|1.5|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.5|-0.71|
71837531|NCT02995434|143181869|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.62|||||TWO_SIDED|95.0|-0.49|1.89|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.89|-0.49|
71837532|NCT02995434|143181869|EQUIVALENCE|See comments in primary outcome|Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-1.19|1.09|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.09|-1.19|
71837533|NCT02995434|143181869|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|0.33|||||TWO_SIDED|95.0|-0.88|1.57|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||1.57|-0.88|
71837534|NCT02995434|143181870|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.48|||||TWO_SIDED|95.0|0.02|4.7|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.70|0.02|
71837535|NCT02995434|143181870|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|2.04|||||TWO_SIDED|95.0|-0.42|4.39|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||4.39|-0.42|
71671454|NCT03985800|142860199|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|6.41||||0.17||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 6.41 with two degrees of freedom.||Aim 2b., moderation by site. Null hypothesis: Site does not moderate the trajectory of complexity score by treatment group.||||0.17
71837536|NCT02995434|143181870|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.79|||||TWO_SIDED|95.0|1.02|6.08|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||6.08|1.02|
71837537|NCT02995434|143181870|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|3.18|||||TWO_SIDED|95.0|0.68|5.69|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||5.69|0.68|
71837538|NCT02995434|143181871|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-2.31|||||TWO_SIDED|95.0|-5.63|0.98|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||0.98|-5.63|
71837539|NCT02995434|143181871|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-7.35|-0.48|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||-0.48|-7.35|
71837540|NCT02995434|143181871|EQUIVALENCE|See comment in primary outcome|Mean Difference (Net)|-0.87|||||TWO_SIDED|95.0|-4.11|2.62|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method|||2.62|-4.11|
71837541|NCT02995434|143181871|EQUIVALENCE|See comments in primary outcome|Median Difference (Net)|-2.95|||||TWO_SIDED|95.0|-6.1|0.41|||||Treatment effect = VR group - Control group; 95% confidence intervals estimated using the bootstrapping method.|||0.41|-6.10|
71837542|NCT04318548|143181896|NON_INFERIORITY|NI was to be demonstrated if the lower limit (LL) of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M14459 (fHbp) strain was above (\>) 0.5|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority (NI) of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.77|
71837543|NCT04318548|143181896|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against 96217 (NadA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.04|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.04|0.75|
71837544|NCT04318548|143181896|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against NZ98/254 (PorA) strain was \>0.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.12|0.76|
71837545|NCT04318548|143181896|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the GMT ratio between the MenB+MenACWY group and MenB group for hSBA titers against M13520 (NHBA) strain was \>0.5|GMT Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis serogroup B indicator strains at one month after the second vaccination with rMenB+OMV NZ (at Day 91).||1.06|0.73|
71892335|NCT01381094|143306449|SUPERIORITY||||||=|0.0007|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0007
71756630|NCT00541658|143016786|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.723|||||TWO_SIDED|95.0|-0.975|8.421|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||8.421|-0.975|
71892336|NCT01381094|143306449|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71677192|NCT04143594|142873004|SUPERIORITY||Difference in percentage|-5.5||||0.2398|TWO_SIDED|95.0|-15.9|4.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.8|-15.9|0.2398
71756631|NCT00541658|143016787|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.798|||||TWO_SIDED|95.0|-0.195|9.79|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.790|-0.195|
71756632|NCT00541658|143016787|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.972|||||TWO_SIDED|95.0|0.02|9.924|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||9.924|0.020|
71756633|NCT00541658|143016788|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.775|||||TWO_SIDED|95.0|-0.514|10.065|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.065|-0.514|
71756634|NCT00541658|143016788|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.638||||||95.0|0.356|10.92|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.920|0.356|
71756635|NCT00541658|143016789|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.552|||||TWO_SIDED|95.0|1.162|11.942|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||11.942|1.162|
71788802|NCT02618434|143075087|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.141||0.4769|TWO_SIDED|95.0|-0.38|0.18|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.18|-0.38|0.4769
71788803|NCT02618434|143075088|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.113||0.0881|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.03|-0.41|0.0881
71788804|NCT02618434|143075088|SUPERIORITY||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.135||0.0522|TWO_SIDED|95.0|-0.53|0.0|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.00|-0.53|0.0522
71788805|NCT02618434|143075088|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.156||0.1766|TWO_SIDED|95.0|-0.52|0.1|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.10|-0.52|0.1766
71892337|NCT01381094|143306449|SUPERIORITY||||||=|0.5522|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5522
71892338|NCT01381094|143306449|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0031
71892339|NCT01381094|143306449|SUPERIORITY||||||=|0.2188|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2188
71837546|NCT04318548|143181897|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men A serogroup was \>0.5.|GMT Ratio|0.94|||||TWO_SIDED|95.0|0.78|1.14|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men A, at one month after the vaccination with MenACWY (at Day 31).||1.14|0.78|
71837547|NCT04318548|143181897|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men C serogroup was \>0.5.|GMT Ratio|1.11|||||TWO_SIDED|95.0|0.86|1.44|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men C, at one month after the vaccination with MenACWY (at Day 31).||1.44|0.86|
71837548|NCT04318548|143181897|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men W serogroup was \>0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.21|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men W, at one month after the vaccination with MenACWY (at Day 31).||1.21|0.82|
71892340|NCT01381094|143306449|SUPERIORITY||||||=|0.0054|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0054
71837549|NCT04318548|143181897|NON_INFERIORITY|NI was to be demonstrated if LL of the 2-sided 95% CI of the between-group ratio of hSBA GMTs between MenB+MenACWY group and MenACWY group for Men Y serogroup was \>0.5.|GMT Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.27|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To demonstrate the non-inferiority of the antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against the N. meningitidis serogroup Men Y, at one month after the vaccination with MenACWY (at Day 31).||1.27|0.84|
71837550|NCT04318548|143181899|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M14459 (fHbp) strain at one month after the fisrt vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.64|
71892341|NCT01381094|143306449|SUPERIORITY||||||=|0.0037|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0037
71892342|NCT01381094|143306449|SUPERIORITY||||||=|0.9521|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9521
71892343|NCT01381094|143306450|SUPERIORITY||||||=|0.3943|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.3943
71892344|NCT01381094|143306450|SUPERIORITY||||||=|0.2096|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.2096
71892345|NCT01381094|143306450|SUPERIORITY||||||=|0.0637|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0637
71892346|NCT01381094|143306450|SUPERIORITY||||||=|0.5016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.5016
71892347|NCT01381094|143306450|SUPERIORITY||||||=|0.7549|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.7549
71892348|NCT01381094|143306450|SUPERIORITY||||||=|0.5991|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5991
71892349|NCT01381094|143306450|SUPERIORITY||||||=|0.4258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4258
71892350|NCT01381094|143306450|SUPERIORITY||||||=|0.0336|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0336
71756636|NCT00541658|143016789|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.531|||||TWO_SIDED|95.0|0.164|10.897|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||10.897|0.164|
71756637|NCT00541658|143016790|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.83|||||TWO_SIDED|95.0|1.175|14.485|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.485|1.175|
71756638|NCT00541658|143016790|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|8.383|||||TWO_SIDED|95.0|1.757|15.01|||ANOVA|Fixed effects for treatment, pooled centers and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||15.010|1.757|
71756639|NCT00541658|143016791|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.802|||||TWO_SIDED|95.0|1.385|14.22|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||14.220|1.385|
71756640|NCT00541658|143016791|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.301|||||TWO_SIDED|95.0|0.911|13.69|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||13.690|0.911|
71756641|NCT00541658|143016792|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.755|||||TWO_SIDED|95.0|-1.145|4.655|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.655|-1.145|
71756642|NCT00541658|143016792|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.805|||||TWO_SIDED|95.0|-1.087|4.698|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.698|-1.087|
71756643|NCT00541658|143016793|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.407|||||TWO_SIDED|95.0|-0.502|5.316|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.316|-0.502|
71756644|NCT00541658|143016793|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.309|||||TWO_SIDED|95.0|-1.576|4.194|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.194|-1.576|
71756645|NCT00541658|143016794|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.555|||||TWO_SIDED|95.0|-1.617|4.727|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.727|-1.617|
71788806|NCT02618434|143075089|SUPERIORITY||Mean Difference (Net)|1.54|STANDARD_ERROR_OF_MEAN|1.613||0.3409|TWO_SIDED|95.0|-1.64|4.72|||ANCOVA|||This analysis pertains to the Physical Functioning Summary Score at Visit 6.||4.72|-1.64|0.3409
71671455|NCT03985800|142860199|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|2.6||||0.27||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 2.6 with two degrees of freedom.||Aim 2b., moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of complexity score by treatment group.||||0.27
71837551|NCT04318548|143181899|OTHER||GMT Ratio|0.62|||||TWO_SIDED|95.0|0.49|0.77|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis 96217 (NadA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.77|0.49|
71837552|NCT04318548|143181899|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.91|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis NZ98/254 (PorA) strain at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.91|0.58|
71837553|NCT04318548|143181899|OTHER||GMT Ratio|0.76|||||TWO_SIDED|95.0|0.64|0.9|||ANOVA||The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.|To assess the immune response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, measured by hSBA GMTs against N. meningitidis M13520 (NHBA) at one month after the first vaccination with rMenB+OMV NZ (at Day 31).||0.90|0.64|
71837554|NCT05521308|143181980|SUPERIORITY||Mean Difference (Final Values)|0.38|||<|0.001|TWO_SIDED|95.0|0.2|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #2 and Same counts.||1.00|0.20|<0.001
71837555|NCT05521308|143181980|SUPERIORITY||Mean Difference (Final Values)|3.23||||0.02|TWO_SIDED|95.0|0.41|6.05|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #2 preference counts per participant.||6.05|0.41|0.02
71837556|NCT05521308|143181980|SUPERIORITY||Mean Difference (Final Values)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #1, Variation #3 and Same counts.||1.00|0.18|<0.001
71837557|NCT05521308|143181980|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.54|TWO_SIDED|95.0|-1.36|3.55|||t-test, 2 sided|||This is to see if there is a difference between Variation #1 and Variation #3 preference counts per participant.||3.55|-1.36|.54
71892351|NCT01381094|143306450|SUPERIORITY||||||=|0.0258|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0258
71892352|NCT01381094|143306450|SUPERIORITY||||||=|0.2412|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.2412
71756646|NCT00541658|143016794|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.612|||||TWO_SIDED|95.0|-1.556|4.779|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.779|-1.556|
71837558|NCT05521308|143181980|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.231|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in preference count per participant between Variation #2, Variation #3, and Same counts.||1.00|0|.231
71837559|NCT05521308|143181982|SUPERIORITY||Cramer's V|0.14||||0.13|TWO_SIDED||||||Chi-squared|This is to see if there is a difference in preference counts between standard curve, variation #4, and # of times they were rated as the same. -Indoor||||||.13
71837560|NCT05521308|143181982|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED|||||This is to see if there is a difference in preference counts between standard curve, variation #4, and # of time they were rated as the same. -Outdoor|Chi-squared|||||||0.04
71837561|NCT05521308|143181982|SUPERIORITY||Cramer's V|0.2||||0.04|TWO_SIDED||||||Chi-squared|||The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors.||||0.04
71837562|NCT05521308|143181983|SUPERIORITY||Effect Size|0.26|||<|0.001|TWO_SIDED|95.0|0.1|1.0|||ANOVA|Initally this is to see if there is a differnce between Unaided, Aided #1 and Aided #2.||Standard Curve vs Variation #4||1.00|0.10|<0.001
71837563|NCT05521308|143181983|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.855|TWO_SIDED|95.0|-2.83|2.35||Post-Hoc Pairwise Comparison|t-test, 2 sided|Standard Curve vs Variation #4||||2.35|-2.83|0.855
71837564|NCT05875142|143182015|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0008|||||||t-test, 1 sided|||T compared with TM||||0.0008
71892353|NCT01381094|143306450|SUPERIORITY||||||=|0.0031|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0031
71892354|NCT01381094|143306450|SUPERIORITY||||||=|0.7705|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7705
71671456|NCT03985800|142860200|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.21||||0.9||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 0.21 with two degrees of freedom.||Aim 1. The trajectory of PHQ-ADS does not differ by treatment group.||||0.90
71756647|NCT00541658|143016795|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.434|||||TWO_SIDED|95.0|-1.652|4.521|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.521|-1.652|
71837565|NCT05875142|143182015|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||5.03e-06|||||||t-test, 1 sided|||T compared with TMC.||||0.00000503
71837566|NCT05875142|143182016|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0176|||||||t-test, 1 sided|||T compared with T||||0.0176
71837567|NCT05875142|143182016|NON_INFERIORITY|test of non-inferiority is H0: control\>=treatment vs HA: control\<treatment||||||0.0056|||||||t-test, 1 sided|||Comparing T with TMC.||||0.0056
71837568|NCT05875142|143182017|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4066|||||||t-test, 1 sided|||T compared with TM||||0.4066
71837569|NCT05875142|143182017|NON_INFERIORITY|test of non-inferiority is H0: control\<=treatment vs HA: control\>treatment||||||0.4045|||||||t-test, 1 sided|||T compared with TMC||||0.4045
71837570|NCT04274764|143182030|OTHER|||||||0.7399|||||||Chi-squared|||||||0.7399
71837571|NCT02677298|143182031|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71837572|NCT02677298|143182032|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
71837573|NCT02677298|143182033|SUPERIORITY|||||||0.003||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.003
71837574|NCT02677298|143182034|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
71837575|NCT02677298|143182034|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
71837576|NCT02677298|143182035|SUPERIORITY|||||||0.084||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.084
71837577|NCT02677298|143182036|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for the Modified Skindex-16 (GL-QoL) Emotional domain change from baseline at week 4||||<0.001
71837578|NCT02677298|143182036|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Functioning domain - Change from baseline at Week 4||||<0.001
71837579|NCT02677298|143182036|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||This test was performed for the Modified Skindex-16 (GL-QoL) Overall score||||<0.001
71837580|NCT02677298|143182036|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Appraisal of Lines Between Eyebrows Scale - Change from Baseline at Week 4||||<0.001
71837581|NCT02677298|143182036|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test was performed for the FACE-Q Age Appraisal VAS score||||<0.001
71677193|NCT04143594|142873004|SUPERIORITY||Difference in percentage|-7.4||||0.1639|TWO_SIDED|95.0|-18.3|3.4||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||3.4|-18.3|0.1639
71837582|NCT03210272|143182057|OTHER||Geometric Mean Ratio T/R (%)|155.6|||||TWO_SIDED|90.0|130.66|185.3|||||intra-individual gCV (%) = 18.1|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||185.30|130.66|
71837583|NCT03210272|143182057|OTHER||Ratio T/R (%)|240.12|||||TWO_SIDED|90.0|196.25|293.81|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||293.81|196.25|
71837584|NCT03210272|143182058|OTHER||Geometric Mean Ratio T/R (%)|156.37|||||TWO_SIDED|90.0|132.73|184.22|||||intra-individual gCV (%) = 17.0|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||184.22|132.73|
71788807|NCT02618434|143075089|SUPERIORITY||Mean Difference (Net)|-2.21|STANDARD_ERROR_OF_MEAN|0.952||0.0215|TWO_SIDED|95.0|-4.08|-0.33|||ANCOVA|||This analysis pertains to the Psychosocial Health Summary Score at Visit 6.||-0.33|-4.08|0.0215
71788808|NCT02618434|143075090|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|2.0||0.5977|TWO_SIDED|95.0|-5.0|2.89|||ANCOVA|||This analysis pertains to the Total Score at Visit 6.||2.89|-5.00|0.5977
71788809|NCT02618434|143075090|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.807||0.8049|TWO_SIDED|95.0|-1.39|1.79|||ANCOVA|||This analysis pertains to the Parental Distress Domain score at Visit 6.||1.79|-1.39|0.8049
71788810|NCT02618434|143075090|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.801||0.8911|TWO_SIDED|95.0|-1.47|1.69|||ANCOVA|||This analysis pertains to the Parent-Child Dysfunctional Interaction score at Visit 6.||1.69|-1.47|0.8911
71788811|NCT02618434|143075090|SUPERIORITY||Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.849||0.1426|TWO_SIDED|95.0|-2.93|0.42|||ANCOVA|||This analysis pertains to the Difficult Child Domain score Visit 6.||0.42|-2.93|0.1426
71788812|NCT02618434|143075091|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.134||0.6171|TWO_SIDED|95.0|-0.33|0.2|||Mixed Models Analysis|||This analysis pertains to Visit 4||0.20|-0.33|0.6171
71788813|NCT02618434|143075091|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.143||0.0617|TWO_SIDED|95.0|-0.55|0.01|||Mixed Models Analysis|||This analysis pertains to Visit 5||0.01|-0.55|0.0617
71788814|NCT02618434|143075091|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.4419|TWO_SIDED|95.0|-0.47|0.21|||Mixed Models Analysis|||This analysis pertains to Visit 6||0.21|-0.47|0.4419
71788815|NCT02618434|143075092|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.0416|TWO_SIDED|95.0|-0.32|-0.01|||ANCOVA|||This analysis pertains to the Inattention subscale at Visit 6.||-0.01|-0.32|0.0416
71788816|NCT02618434|143075092|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.089||0.0921|TWO_SIDED|95.0|-0.33|0.02|||ANCOVA|||This analysis pertains to Hyperactivity/Impulsivity subscale at Visit 6||0.02|-0.33|0.0921
71788817|NCT02618434|143075092|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.094||0.448|TWO_SIDED|95.0|-0.26|0.11|||ANCOVA|||This analysis pertains to the Oppositional Defiant Disorder subscale at Visit 6||0.11|-0.26|0.4480
71788818|NCT02618434|143075092|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.077||0.0457|TWO_SIDED|95.0|-0.31|0.0|||ANCOVA|||This analysis pertains to the Combined Scale score at Visit 6||-0.00|-0.31|0.0457
71788819|NCT02618434|143075093|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8525|TWO_SIDED|95.0|0.58|1.93|||Regression, Logistic|||This analysis pertains to ≥ 30% Responders.||1.93|0.58|0.8525
71788820|NCT02618434|143075093|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6635|TWO_SIDED|95.0|0.52|1.51|||Regression, Logistic|||This analysis pertains to ≥ 50% Responders.||1.51|0.52|0.6635
71788821|NCT01988103|143075094|SUPERIORITY_OR_OTHER_LEGACY||Difference|16.4||||0.0032|TWO_SIDED|95.0|5.8|27.0|||Chi-squared|||||27.0|5.8|0.0032
71788822|NCT01988103|143075094|SUPERIORITY_OR_OTHER_LEGACY||Difference|21.1||||0.0003|TWO_SIDED|95.0|10.1|32.1|||Chi-squared|||||32.1|10.1|0.0003
71788823|NCT01988103|143075095|SUPERIORITY_OR_OTHER_LEGACY||Difference|15.1||||0.0165|TWO_SIDED|95.0|3.1|27.1|||Chi-squared|||||27.1|3.1|0.0165
71788824|NCT01988103|143075095|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.8||||0.002|TWO_SIDED|95.0|8.2|33.3|||Chi-squared||Missing values were imputed using the LOCF method.|||33.3|8.2|0.0020
71788825|NCT01988103|143075096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.1||||0.0003|TWO_SIDED|95.0|-44.5|-13.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-13.6|-44.5|0.0003
71788826|NCT01988103|143075096|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.0|||<|0.0001|TWO_SIDED|95.0|-53.4|-22.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-22.6|-53.4|<0.0001
71788827|NCT01988103|143075097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.5||||0.0002|TWO_SIDED|95.0|-44.9|-14.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-14.0|-44.9|0.0002
71788828|NCT01988103|143075097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.5|||<|0.0001|TWO_SIDED|95.0|-54.9|-24.1|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-24.1|-54.9|<0.0001
71788829|NCT01988103|143075098|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.7||||0.0057|TWO_SIDED|95.0|6.1|33.4|||Chi-squared|||||33.4|6.1|0.0057
71788830|NCT01988103|143075098|SUPERIORITY_OR_OTHER_LEGACY||Difference|29.2|||<|0.0001|TWO_SIDED|95.0|15.4|42.9|||Chi-squared|||||42.9|15.4|<0.0001
71788831|NCT01988103|143075099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6||||0.0003|TWO_SIDED|95.0|-22.6|-6.7|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-6.7|-22.6|0.0003
71671457|NCT03985800|142860200|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.21||||0.55||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|||Aim 2a, moderation by disease activity. Null hypothesis: Disease activity does not moderate the trajectory of behavioral health score by treatment group.||||0.55
71788832|NCT01988103|143075099|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.7|-16.9|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate. Missing values were imputed using the LOCF method.|||-16.9|-32.7|<0.0001
71788833|NCT01988103|143075100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0204|TWO_SIDED|95.0|-3.2|-0.3|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-0.3|-3.2|0.0204
71788834|NCT01988103|143075100|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|||<|0.0001|TWO_SIDED|95.0|-4.9|-2.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||-2.0|-4.9|<0.0001
71788835|NCT01988103|143075101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88||||0.5149|TWO_SIDED|95.0|-1.78|3.53|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||3.53|-1.78|0.5149
71788836|NCT01988103|143075101|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.85||||0.1693|TWO_SIDED|95.0|-0.79|4.5|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.|||4.50|-0.79|0.1693
71788837|NCT03590041|143075107|SUPERIORITY|||||||0.04||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in Patient-Driven SMAs would have greater reductions in Diabetes Distress than those in Standardized SMAs. We expected seeing an effect size of a .6 unit decrease (.30) in Standardized SMAs and 1.2 unit decrease (.60) in Patient-Driven SMAs. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.04
71788838|NCT03590041|143075108|SUPERIORITY|||||||0.82||||||Linear Mixed Model adjusted for a priori patient covariates: Race/Ethnicity, Gender, Health Literacy, Food Availability, Charlson Score, Mental Illness, Substance use. Adjusted P-value represents the significance test for the time x group interaction|Mixed Models Analysis|||We hypothesized that patients in the Patient-Driven condition would have a greater reduction in HbA1c than patients in the Standardized condition. We estimate we have \>80% power to detect effect sizes between .29 (ICC=3%) and .34 (ICC=5%).||||0.82
71788839|NCT03315208|143075110|SUPERIORITY||Chi-squared statistic value|0.23||||0.63|TWO_SIDED||||||Chi-squared, Corrected|df=1||||||0.63
71788840|NCT03315208|143075111|SUPERIORITY||Slope|0.72||||0.29|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.29
71788841|NCT03315208|143075112|SUPERIORITY||Slope|-0.56||||0.5|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.50
71788842|NCT03315208|143075113|SUPERIORITY||Slope|-1.96||||0.45|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. BSI scores were binarized (0 and \>=1) for this analysis due to the non-normal distribution of this outcome.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.45
71788843|NCT03315208|143075115|SUPERIORITY||Slope|-0.19||||0.76|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||0.76
71813304|NCT01342458|143129061|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||<0.001
71813305|NCT01342458|143129061|SUPERIORITY_OR_OTHER||Effect size|1.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71837585|NCT03210272|143182058|OTHER||Ratio T/R (%)|245.56|||||TWO_SIDED|90.0|200.7|300.44|||||intra-individual gCV (%) = 27.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||300.44|200.70|
71813306|NCT01342458|143129061|SUPERIORITY_OR_OTHER||Effect size|1.69||||0.019|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||0.019
71813307|NCT01342458|143129061|SUPERIORITY_OR_OTHER||Effect size|0.66|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71813308|NCT01342458|143129061|SUPERIORITY_OR_OTHER||Effect size|0.44|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71813309|NCT01342458|143129062|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.019
71813310|NCT01342458|143129062|SUPERIORITY_OR_OTHER||Effect size|1.07|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71813311|NCT01342458|143129062|SUPERIORITY_OR_OTHER||Effect size|1.31|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71813312|NCT01342458|143129062|SUPERIORITY_OR_OTHER||Effect size|0.71|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 3rd month.||||<0.001
71813313|NCT01342458|143129062|SUPERIORITY_OR_OTHER||Effect size|0.45|||<|0.001|TWO_SIDED||||||post hoc Newman-Keuls|||From baseline to 6th month.||||<0.001
71813314|NCT01342458|143129063|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.425
71813315|NCT01342458|143129064|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).||||0.443
71813316|NCT01342458|143129065|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference in paracetamol intake at 6-month.||||<0.001
71813317|NCT01181726|143129074|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.66|||||TWO_SIDED|90.0|94.22|116.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.25|94.22|
71813318|NCT01181726|143129075|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||TWO_SIDED|90.0|93.91|101.02|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.02|93.91|
71813319|NCT01181726|143129076|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|94.05|101.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.30|94.05|
71813320|NCT01181726|143129077|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.35|||||TWO_SIDED|90.0|92.21|107.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.06|92.21|
71813321|NCT01181726|143129078|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.21|||||TWO_SIDED|90.0|91.21|99.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.39|91.21|
71813322|NCT01181726|143129079|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.25|||||TWO_SIDED|90.0|91.18|99.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.51|91.18|
71837586|NCT03210272|143182059|OTHER||Geometric Mean Ratio T/R (%)|158.74|||||TWO_SIDED|90.0|114.25|220.56|||||intra-individual gCV (%) = 34.8|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||220.56|114.25|
71837587|NCT03210272|143182059|OTHER||Ratio T/R (%)|246.13|||||TWO_SIDED|90.0|203.37|297.89|||||intra-individual gCV (%) = 26.2|The statistical model to assess relative bioavailability in the FE part was an analysis of variance (ANOVA) on the ln-transformed parameters AUC and Cmax including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'||297.89|203.37|
71837588|NCT03039023|143182078|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.2||||||A p-value \<0.05 was considered significant.|Wilcoxon signed-rank test|||||||0.20
71671458|NCT03985800|142860200|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|1.37||||0.5||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*age interaction term is 1.37 with two degrees of freedom.||Aim 2b, moderation by age. Null hypothesis: Age does not moderate the trajectory of behavioral health score by treatment group.||||0.50
71671459|NCT03985800|142860200|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|5.16||||0.08||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*diagnosis interaction term is 5.16 with two degrees of freedom.||Aim 2b, moderation by diagnosis. Null hypothesis: Diagnosis does not moderate the trajectory of behavioral health score by treatment group.||||0.08
71671460|NCT03985800|142860200|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|0.11||||1||||||Threshold for statistical significance was 0.05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*site interaction term is 0.11 with two degrees of freedom.||Aim 2b, moderation by site. Null hypothesis: Site does not moderate the trajectory of behavioral health score by treatment group.||||1.0
71756648|NCT00541658|143016795|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.462|||||TWO_SIDED|95.0|-1.611|4.535|||ANOVA|Fixed effect for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||4.535|-1.611|
71756649|NCT00541658|143016796|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.749|||||TWO_SIDED|95.0|-0.938|6.436|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||6.436|-0.938|
71756650|NCT00541658|143016796|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.416|||||TWO_SIDED|95.0|-0.255|7.087|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus daily treatment.|||7.087|-0.255|
71837589|NCT03039023|143182078|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837590|NCT03039023|143182078|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837591|NCT03039023|143182078|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837592|NCT03039023|143182078|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.27||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.27
71837593|NCT03039023|143182079|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.1||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.10
71837594|NCT03039023|143182079|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.0002||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.0002
71837595|NCT03039023|143182079|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
71837596|NCT03039023|143182079|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.006||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.006
71837597|NCT03039023|143182079|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.79||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.79
71756651|NCT00541658|143016797|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.197|||||TWO_SIDED|95.0|-1.318|5.711|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.711|-1.318|
71756652|NCT00541658|143016797|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.251|||||TWO_SIDED|95.0|-1.248|5.751|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant use.|LS Mean Difference is 5 mg daily minus weekly treatment.|||5.751|-1.248|
71756653|NCT00541658|143016798|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
71756654|NCT00541658|143016798|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
71756655|NCT00541658|143016799|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
71756656|NCT00541658|143016799|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
71788844|NCT03315208|143075116|SUPERIORITY||Slope|-1.07||||0.21|TWO_SIDED|||||p-value is for the model parameter of the condition-by-time interaction term.|Mixed Models Analysis||The treatment condition effect was determined by the model parameter of the condition-by-time interaction term. Due to the non-normal distribution of the Craving Scale, scores on this measure were binarized (\< 15 and \>= 15) for this analysis.|Linear mixed effects models with random intercepts (as best practice likelihood ratio tests dropping random slopes and intercepts indicated that only random intercepts should be retained) were used, with restricted maximum likelihood estimation (REML) for missing data. Analyses were intent-to-treat so included all randomized participants (n=29 in the UP+TAU group and n=18 in the TAU alone group), regardless of whether or not they completed the mid- or post-treatment assessments.||||.21
71837598|NCT03039023|143182080|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.28||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.28
71837599|NCT03039023|143182080|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837600|NCT03039023|143182080|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837601|NCT03039023|143182080|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837602|NCT03039023|143182080|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.11||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.11
71837603|NCT03039023|143182081|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.005||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.005
71837604|NCT03039023|143182081|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
71837605|NCT03039023|143182081|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.001
71837606|NCT03039023|143182081|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.009||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.009
71837607|NCT03039023|143182081|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
71837608|NCT03039023|143182082|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.93||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.93
71837609|NCT03039023|143182082|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.01||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.01
71837610|NCT03039023|143182082|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.003||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.003
71671461|NCT03985800|142860200|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.23||||0.2||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|The Chi-squared statistic for the group\*time\*eHealth literacy interaction term is 3.23 with two degrees of freedom.||Aim 2b, moderation by eHealth literacy. Null hypothesis: eHealth literacy does not moderate the trajectory of behavioral health score by treatment group.||||0.20
71837611|NCT03039023|143182082|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.04||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.04
71837612|NCT03039023|143182082|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.99||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.99
71837613|NCT03039023|143182083|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
71837614|NCT03039023|143182083|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837615|NCT03039023|143182083|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.|||||<|0.0001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||<0.0001
71837616|NCT03039023|143182083|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.001||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.001
71837617|NCT03039023|143182083|EQUIVALENCE|For equivalence testing, the difference was assumed to be 0.||||||0.02||||||A p-value \<0.05 was considered significant.|Wilcoxon Signed Rank test|||||||0.02
71837618|NCT03232138|143182113|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.22||||0.452|TWO_SIDED|95.0|0.03|0.41||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking.||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.41|0.03|0.452
71837619|NCT03232138|143182113|EQUIVALENCE|2-sided P-value in the analysis|Mean Difference (Final Values)|0.12||||0.452|TWO_SIDED|95.0|-0.04|0.28||Hypothesis: sulforaphane treatment slows or reverse the progression of lung histological lesions or lower the dysplasia score.|ANCOVA|ANCOVA model includes baseline average endobronchial histopathological scores,age,sex,cigarettes per day,years of smoking, years since quit smoking||Derived from ANCOVA model with adjustment for baseline average endobronchial histopathological scores, age, sex, cigarettes per day, years of smoking, and years since quit smoking.||0.28|-0.04|0.452
71837620|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.738||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||All positive nuclei. Mean (95%CI) changes in baseline.||||0.738
71837621|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.78||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.780
71837622|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.733||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Moderate intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.733
71837623|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.751||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Strong-Intensity positive nuclei. Mean (95%CI) changes in baseline.||||0.751
71837624|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.014||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of Ki-67 positive nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.014
71837625|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.056|||||||Covariance|Analysis of Covariance adjustment age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Week intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.056
71756657|NCT00541658|143016800|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
71756658|NCT00541658|143016800|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
71756659|NCT00541658|143016801|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
71756660|NCT00541658|143016801|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
71756661|NCT00541658|143016802|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|TWO_SIDED|95.0|0.14|7.05|||Fisher Exact|||||7.05|0.14|1.0000
71756662|NCT00541658|143016802|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|TWO_SIDED|95.0|0.25|8.9|||Fisher Exact|||||8.90|0.25|1.0000
71756663|NCT00541658|143016803|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|TWO_SIDED|95.0|0.15|7.29|||Fisher Exact|||||7.29|0.15|1.0000
71756664|NCT00541658|143016803|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|TWO_SIDED|95.0|0.25|8.87|||Fisher Exact|||||8.87|0.25|1.0000
71756665|NCT00541658|143016804|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|TWO_SIDED|95.0|0.08|2.14|||Fisher Exact|||||2.14|0.08|0.4505
71756666|NCT00541658|143016804|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|TWO_SIDED|95.0|0.22|3.03|||Fisher Exact|||||3.03|0.22|1.0000
71788845|NCT03315208|143075117|SUPERIORITY||t statistic|0.29||||0.77|TWO_SIDED||||||t-test, 2 sided|||Due to the non-normal distribution of the PDA variable, this variable was treated as binary (\<50% and \>=50%) for mixed models; however, due to the small numbers of participants (\< 5) in certain cells of treatment condition (UP versus TAU) by time point, we ran into issues with convergence of linear mixed models. Thus, here we report the results from an independent samples t-test of means (percentage of past 30 days abstinent) at post-treatment (UP versus TAU).||||0.77
71788846|NCT00456547|143075139|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Adjusted for 12 comparisons|t-test, 2 sided|||||||<0.05
71788847|NCT00456547|143075140|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons.|t-test, 2 sided|||||||<0.05
71788848|NCT00456547|143075141|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|t-test, 2 sided|||||||<0.05
71788849|NCT00456547|143075142|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Corrected for 12 comparisons|Wilcoxon (Mann-Whitney)|||||||<0.05
71788850|NCT01896531|143075176|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.12|||=|0.56|TWO_SIDED|90.0|0.81|1.55|||Log Rank|||All randomized participants||1.55|0.81|= 0.56
71837626|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.028|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Moderate Intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.028
71671462|NCT03985800|142860201|SUPERIORITY|Considering a range of effect sizes for B1, B2, and B3, we estimated the outcome Y as Y=B1\*X+B2\*M+B3\*X\*M+ε, where ε\~N(0,1). Using Monte Carlo methods, we averaged across scenarios to determine the typical effect of B3 that can be detected with our current and projected sample sizes after 25% attrition. With our projected sample sizes we expect 0.80 power to detect a significant interaction when the magnitude of B3 is at least 0.50.|Type III Wald chi-squared|3.09||||0.53||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 3.09 with two degrees of freedom.||Null hypothesis: The trajectory of functional impairment does not differ by treatment group.||||0.53
71837627|NCT03232138|143182114|EQUIVALENCE|2-sided P-value in the analysis||||||0.004|||||||Analysis of Covariance|Analysis of Covariance adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking,baseline values of the same cellular biomarker||Strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.004
71837628|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.377||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) baseline.||||0.377
71837629|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis||||||0.413||||||Hypothesis: Sulforaphane treatment inhibits or reduces number of Ki-67 positive nuclei in bronchial biopsy as compared with the placebo.|Analysis of Covariance|||Weak-intensity positive nuclei. Mean (95%CI) baseline.||||0.413
71837630|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline Moderate-intensity positive nuclei. TUNEL positive (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.338||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies compared with the place|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate Intensity positive nuclei. Mean (95%CI) at baseline.||||0.338
71837631|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) at baseline for positive cells. TUNEL positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) baseline.||||0.547
71837632|NCT03232138|143182115|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.291||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.291
71837633|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.552||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Weak-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.552
71677194|NCT04143594|142873004|SUPERIORITY||Difference in percentage|-5.7||||0.2307|TWO_SIDED|95.0|-16.3|4.9||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||4.9|-16.3|0.2307
71837634|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.205||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Moderate-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.205
71788851|NCT01896531|143075176|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.07|||=|0.86|TWO_SIDED|90.0|0.54|2.11|||Log Rank|||Participants with PTEN loss tumors||2.11|0.54|= 0.86
71788852|NCT01896531|143075177|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.52|||=|0.0234|TWO_SIDED|90.0|1.12|2.07|||Log Rank|||All randomized participants||2.07|1.12|= 0.0234
71788853|NCT01896531|143075177|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.2867|TWO_SIDED|90.0|0.75|3.65|||Log Rank|||Participants with PTEN loss tumors||3.65|0.75|= 0.2867
71788854|NCT01896531|143075177|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.66|||=|0.1369|TWO_SIDED|90.0|0.94|2.93|||Log Rank|||Participants who are Akt Dx+||2.93|0.94|= 0.1369
71788855|NCT01896531|143075178|SUPERIORITY||Difference in Response Rates|-5.2|||=|0.5202|TWO_SIDED|90.0|-18.46|8.06|||Cochran-Mantel-Haenszel|||All randomized participants||8.06|-18.46|= 0.5202
71788856|NCT01896531|143075178|SUPERIORITY||Difference in Response Rates|-23.33|||=|0.2035|TWO_SIDED|90.0|-52.24|5.58|||Cochran-Mantel-Haenszel|||Participants with PTEN loss tumors||5.58|-52.24|= 0.2035
71788857|NCT01896531|143075178|SUPERIORITY||Difference in Response Rates|-4.35|||=|0.7697|TWO_SIDED|90.0|-28.48|19.79|||Cochran-Mantel-Haenszel|||Participants who are Akt Dx+||19.79|-28.48|= 0.7697
71788858|NCT01896531|143075179|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|1.14|||=|0.5974|TWO_SIDED|90.0|0.76|1.73|||Log Rank|||All randomized participants||1.73|0.76|= 0.5974
71788859|NCT01896531|143075179|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.71|||=|0.5385|TWO_SIDED|90.0|0.28|1.79|||Log Rank|||Participants with PTEN loss tumors||1.79|0.28|= 0.5385
71788860|NCT01896531|143075179|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.78|||=|0.6097|TWO_SIDED|90.0|0.35|1.75|||Log Rank|||Participants who are Akt Dx+||1.75|0.35|= 0.6097
71788861|NCT01860651|143075186|OTHER||mean difference over time|-0.002||||0.22|TWO_SIDED|95.0|-0.005|0.001|||Mixed Effect Model|||"Statistical analysis of Medical adherence in study Medication adm. at home were analysed using a Mixed Effect Model (MEM). The MEM model included a random patient effect and a fixed effect interaction between group and time, to evaluate difference between the groups over time."||0.001|-0.005|0.22
71788862|NCT00862745|143075192|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustment for multiple comparisons, threshold for significance is P \< .05|ANCOVA|Mean difference=Drug A minus Drug B||Null hypothesis: fesoterodine treatment is not associated with greater reduction in urgency incontinence frequency compared to placebo in women diagnosed using the 3IQ||||<0.001
71788863|NCT00563381|143075206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83|||<|0.0001||95.0|0.77|0.9|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.90|0.77|<0.0001
71788864|NCT00563381|143075207|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.73|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.66|0.82|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium vs. Salmeterol||0.82|0.66|<0.0001
71788865|NCT00563381|143075208|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0002||95.0|0.85|0.95|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.95|0.85|0.0002
71892355|NCT01381094|143306450|SUPERIORITY||||||=|0.0024|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0024
71788866|NCT00563381|143075209|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0017||95.0|0.83|0.96|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.96|0.83|0.0017
71788867|NCT00563381|143075210|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.0001||95.0|0.61|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.61|<0.0001
71788868|NCT00563381|143075211|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.0005||95.0|0.66|0.89|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||0.89|0.66|0.0005
71788869|NCT00563381|143075212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0242||95.0|0.78|0.98|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.98|0.78|0.0242
71788870|NCT00563381|143075213|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.0406||95.0|0.82|1.0|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol||1.00|0.82|0.0406
71788871|NCT00563381|143075214|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.0001||95.0|0.78|0.91|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.91|0.78|<0.0001
71788872|NCT00563381|143075215|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||<|0.0001||95.0|0.69|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.85|0.69|<0.0001
71788873|NCT00563381|143075216|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||<|0.0001||95.0|0.78|0.92|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.92|0.78|<0.0001
71788874|NCT00563381|143075217|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.68|0.86|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol||0.86|0.68|<0.0001
71788875|NCT00563381|143075218|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.82|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.76|0.9|||Poisson regression|Poisson regression correcting for overdispersion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.90|0.76|<0.0001
71788876|NCT00563381|143075219|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.9|STANDARD_ERROR_OF_MEAN|0.03||0.0036||95.0|0.84|0.97|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.97|0.84|0.0036
71788877|NCT00563381|143075220|SUPERIORITY_OR_OTHER||Rate ratio (ratio of incidence rates)|0.8|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.73|0.88|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol||0.88|0.73|<0.0001
71788878|NCT00563381|143075221|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.6||||0.1035||95.0|-3.53|0.33|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.33|-3.53|0.1035
71788879|NCT00563381|143075222|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.06||||0.0369||95.0|-3.99|-0.12|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week).||Tiotropium versus Salmeterol||-0.12|-3.99|0.0369
71788880|NCT00563381|143075223|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-2.07||||0.0362||95.0|-4.0|-0.13|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||-0.13|-4.00|0.0362
71788881|NCT00563381|143075224|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.88||||0.0573||95.0|-3.82|0.06|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.06|-3.82|0.0573
71788882|NCT00563381|143075225|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2641||95.0|-3.04|0.83|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.83|-3.04|0.2641
71788883|NCT00563381|143075226|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.01||||0.3068||95.0|-2.95|0.93|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.93|-2.95|0.3068
71788884|NCT00563381|143075227|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.78||||0.4299||95.0|-2.72|1.16|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.16|-2.72|0.4299
71788885|NCT00563381|143075228|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.48||||0.6277||95.0|-2.42|1.46|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.46|-2.42|0.6277
71788886|NCT00563381|143075229|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.85||||0.3931||95.0|-2.8|1.1|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.10|-2.80|0.3931
71788887|NCT00563381|143075230|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.97||||0.3297||95.0|-2.92|0.98|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.98|-2.92|0.3297
71788888|NCT00563381|143075231|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.3||||0.1904||95.0|-3.25|0.65|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.65|-3.25|0.1904
71892356|NCT01381094|143306450|SUPERIORITY||||||=|0.0006|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0006
71892357|NCT01381094|143306450|SUPERIORITY||||||=|0.6189|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6189
71892358|NCT01381094|143306450|SUPERIORITY||||||=|0.0075|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0075
71892359|NCT01381094|143306450|SUPERIORITY||||||=|0.0259|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0259
71892360|NCT01381094|143306450|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71892361|NCT01381094|143306450|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71892362|NCT01381094|143306450|SUPERIORITY||||||=|0.8898|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8898
71892363|NCT01381094|143306450|SUPERIORITY||||||=|0.001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0010
71892364|NCT01381094|143306450|SUPERIORITY||||||=|0.2864|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2864
71756667|NCT00541658|143016805|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|TWO_SIDED|95.0|0.08|2.11|||Fisher Exact|||||2.11|0.08|0.4505
71756668|NCT00541658|143016805|NON_INFERIORITY_OR_EQUIVALENCE|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|TWO_SIDED|95.0|0.37|3.9|||Fisher Exact|||||3.90|0.37|0.7719
71756669|NCT02344108|143016858|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71756670|NCT02344108|143016859|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71756671|NCT02344108|143016860|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71756672|NCT02344108|143016861|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
71756673|NCT02344108|143016862|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
71756674|NCT02344108|143016863|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
71756675|NCT02344108|143016864|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71756676|NCT02344108|143016865|SUPERIORITY|||||||0.467|||||||t-test, 2 sided|||||||0.467
71756677|NCT02344108|143016866|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
71788889|NCT00563381|143075232|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.99||||0.3172||95.0|-2.94|0.95|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.95|-2.94|0.3172
71671463|NCT03985800|142860202|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|6.01||||0.05||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 6.01 with two degrees of freedom.||Null hypothesis: The trajectory of IBD-IBS symptom severity does not differ by treatment group.||||0.05
71756678|NCT02344108|143016867|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
71756679|NCT02344108|143016868|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71756680|NCT02344108|143016869|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71756681|NCT02344108|143016870|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71756682|NCT00911170|143016894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.014|TWO_SIDED|95.0|0.19|0.86|||Cochran-Mantel-Haenszel|The p-value is adjusted for the randomization stratification factors (chemotherapy regimen, geographic region, disease stage).|Odds ratio adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|The primary hypothesis was that the percentage of participants treated with study chemotherapy and bevacizumab who experience grade 3/4 febrile neutropenia (FN) would be lower in participants randomized to the pegfilgrastim arm compared to placebo arm. The study was designed to have at least 90% power at the 2-sided 0.05 significance level to detect a 6% difference in incidence of grade 3/4 FN from 9% to 3%, which is approximately a 66.7% relative reduction.||0.86|0.19|0.014
71756683|NCT00911170|143016895|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.704|TWO_SIDED|95.0|0.81|1.36|||Log Rank|P-values based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.36|0.81|0.704
71756684|NCT00911170|143016896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.552|TWO_SIDED|95.0|0.88|1.26|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.26|0.88|0.552
71756685|NCT00911170|143016897|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.502|TWO_SIDED|95.0|0.88|1.29|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR\< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.|||1.29|0.88|0.502
71756686|NCT00911170|143016898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.683|TWO_SIDED|95.0|0.81|1.39|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \> 1.0 indicates a higher event rate for the pegfilgrastim arm relative to the placebo arm.|||1.39|0.81|0.683
71756687|NCT00911170|143016899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.312||95.0|0.29|1.49|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||1.49|0.29|0.312
71671464|NCT03985800|142860203|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|4.14||||0.13||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For hospitalizations, the Chi-squared statistic for the group\*time interaction term is 4.14 with two degrees of freedom||Null hypothesis: The trajectory of hospitalizations does not differ by treatment group.||||0.13
71671465|NCT03985800|142860203|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|0.82||||0.67||||||The threshold for statistical significance was .05.|Mixed Models Analysis|For ED visits, the Chi-squared statistic for the group\*time interaction term is 0.82 with two degrees of freedom.||Null hypothesis: The trajectory of ED visits does not differ by treatment group.||||0.67
71671466|NCT03985800|142860204|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|1.98||||0.37||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 1.98 with two degrees of freedom.||Null hypothesis: The trajectory of self-efficacy does not differ by treatment group.||||0.37
71671467|NCT03985800|142860205|SUPERIORITY|We calculated statistical power for the target sample size of 675 (\~337 in each of TEAM and TECH arms). After adjusting for the multiple testing in Aim 1 (2 tests) and considering 25% attrition, a sample size of 505 (\~252 per treatment group) will provide over 99.9% power for the hypothesis test for Aim 1.|Type III Wald chi-squared|5.57||||0.06||||||The threshold for statistical significance was .05.|Mixed Models Analysis|The Chi-squared statistic for the group\*time interaction term is 5.57 with two degrees of freedom.||Null hypothesis: The trajectory of quality of life does not differ by treatment group.||||0.06
71756688|NCT00911170|143016900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.18|||<|0.001||95.0|0.1|0.32|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.32|0.10|<.001
71756689|NCT00911170|143016901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.13|0.56|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR \< 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|||0.56|0.13|<.001
71788890|NCT00563381|143075233|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.67||||0.5017||95.0|-2.62|1.28|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.28|-2.62|0.5017
71756690|NCT00905164|143016903|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|99.5|||||TWO_SIDED|90.0|94.27|105.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125|||105.03|94.27|
71756691|NCT00905164|143016904|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|100.13||||||90.0|97.6|102.72|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102.72|97.60|
71756692|NCT00905164|143016905|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|101.53||||||90.0|99.01|104.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.12|99.01|
71756693|NCT01389596|143016907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.2577|TWO_SIDED|95.0|-0.29|0.08|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||0.08|-0.29|0.2577
71756694|NCT01389596|143016907|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0185|TWO_SIDED|95.0|-0.41|-0.04|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.||-0.04|-0.41|0.0185
71756695|NCT01389596|143016908|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.036||||0.8024|TWO_SIDED|95.0|0.528|2.03|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||2.030|0.528|0.8024
71788891|NCT00563381|143075234|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.23||||0.2174||95.0|-3.18|0.72|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.72|-3.18|0.2174
71788892|NCT00563381|143075235|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-1.1||||0.2682||95.0|-3.05|0.85|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||0.85|-3.05|0.2682
71756696|NCT01389596|143016908|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.636||||0.0092|TWO_SIDED|95.0|0.851|3.147|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.||3.147|0.851|0.0092
71788893|NCT00563381|143075236|SUPERIORITY_OR_OTHER||difference in peak expiratory flow rates|-0.59||||0.552||95.0|-2.55|1.36|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment\*week; covariates: baseline PEFR, baseline PEFR\*week)||Tiotropium versus Salmeterol||1.36|-2.55|0.5520
71788894|NCT00110149|143075237|OTHER|As the study was not able to be completed the simple number of patients per outcome is listed.|||||||||||||||||The trial was to measure the response rate and EFS of patients but the manufacturer of the investigational agent closed and sold the agent to a new company so the trial was not able to be completed.|||
71837635|NCT03232138|143182115|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. TUNEL all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on number of TUNEL positive nuclei in bronchial biopsies|Analysis of Covariance|Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking, baseline values of positive TUNEL nuclei||Strong-intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.295
71837636|NCT03232138|143182116|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.295||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) at baseline.||||0.295
71837637|NCT03232138|143182116|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.242||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||weak intensity positive nuclei. Mean (95%CI) at baseline.||||0.242
71837638|NCT03232138|143182116|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.985||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) at baseline.||||0.985
71837639|NCT03232138|143182116|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) baseline positive cells. Caspase-3 positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.547||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Strong intensity positive nuclei. Mean (95%CI) at baseline.||||0.547
71837640|NCT03232138|143182116|EQUIVALENCE|used 2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for all positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker.||||||0.778||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||All positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.778
71837641|NCT03232138|143182116|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.685||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Weak intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.685
71837642|NCT03232138|143182116|EQUIVALENCE|-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarker||||||0.469||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||Moderate intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.469
71892365|NCT01381094|143306450|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0002
71671468|NCT04281485|142860206|SUPERIORITY||Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.78|=|0.9116|TWO_SIDED|95.0|-1.46|1.64|||Mixed Models Analysis||||The Mixed Model Repeated Measures (MMRM) model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|1.64|-1.46|=0.9116
71671469|NCT04281485|142860207|SUPERIORITY||Least Square Mean Difference|85.75|STANDARD_ERROR_OF_MEAN|17.17|=|0.0002|TWO_SIDED|95.0|49.15|122.35|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||122.35|49.15|=0.0002
71671470|NCT04281485|142860208|SUPERIORITY||Least Square Mean Difference|51.46|STANDARD_ERROR_OF_MEAN|9.49|<|0.0001|TWO_SIDED|95.0|31.43|71.49|||ANCOVA|The ANCOVA model contained treatment group (categorical variable) and screening age (continuous variable).||||71.49|31.43|<0.0001
71671471|NCT04281485|142860209|SUPERIORITY||Geometric Ratio of LS Means|0.64|||=|0.0002|TWO_SIDED|95.0|0.5|0.81|||Mixed Models Analysis||||MMRM approach for log transformed data including visits through Week 52 where serum CK concentration was assessed with fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction, and with additional fixed effects for natural log of baseline (continuous variable), screening age covariate (continuous variable), natural log of baseline by visit interaction, and screening age covariate by visit interaction with an unstructured variance-covariance matrix.|0.81|0.50|=0.0002
71671472|NCT04281485|142860210|SUPERIORITY||Odds Ratio (OR)|1.73|||=|0.2784|TWO_SIDED|95.0|0.64|4.62|||Binomial regression||||The generalized mixed linear model assumed a binomial distribution with logit link \& contains fixed effects for treatment group (categorical variable) \& screening age (continuous variable).|4.62|0.64|=0.2784
71671473|NCT04281485|142860211|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.5437|TWO_SIDED|95.0|0.63|1.28|||Binomial Regression||||The generalized mixed linear model assumed a binomial distribution with a logit link and contained fixed effects for treatment group (categorical variable) and screening age (continuous variable).|1.28|0.63|=0.5437
71671474|NCT04281485|142860212|SUPERIORITY||Least Square Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.082|=|0.3343|TWO_SIDED|95.0|-0.242|0.083|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.083|-0.242|=0.3343
71671475|NCT04281485|142860213|SUPERIORITY||Least Square Mean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.024|=|0.8826|TWO_SIDED|95.0|-0.052|0.045|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|0.045|-0.052|=0.8826
71671476|NCT04281485|142860214|SUPERIORITY||Least Square Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|1.63|=|0.219|TWO_SIDED|95.0|-1.22|5.24|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|5.24|-1.22|=0.2190
71671477|NCT04281485|142860215|SUPERIORITY||Least Square Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|2.96|=|0.7096||95.0|-4.79|7.0|||Mixed Models Analysis||||The MMRM model contained fixed effects for treatment group (categorical variable), visit (ordered categorical variable), and treatment group by visit interaction with additional fixed effects for baseline value (continuous variable), screening age (continuous variable), baseline value by visit interaction, and screening age by visit interaction with an unstructured variance-covariance matrix.|7.00|-4.79|=0.7096
71756697|NCT00565084|143016933|SUPERIORITY_OR_OTHER||Difference in LS Means|0.06||||0.743||90.0|-0.23|0.35|||ANOVA|||Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.||0.35|-0.23|0.743
71756698|NCT02085161|143016964|SUPERIORITY_OR_OTHER||Treatment ratio|1.458|STANDARD_ERROR_OF_MEAN|0.147||0.0002|TWO_SIDED|95.0|1.196|1.777||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|This treatment comparison is the first one in the alpha-protected hierarchical testing chain.||1.777|1.196|0.0002
71756699|NCT02085161|143016964|SUPERIORITY_OR_OTHER||Treatment ratio|1.292|STANDARD_ERROR_OF_MEAN|0.129||0.0109|TWO_SIDED|95.0|1.061|1.573||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the second one in the alpha-protected hierarchical testing chain.||1.573|1.061|0.0109
71756700|NCT02085161|143016964|SUPERIORITY_OR_OTHER||Treatment ratio|1.041|STANDARD_ERROR_OF_MEAN|0.106||0.6895|TWO_SIDED|95.0|0.853|1.272||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is \>0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.||1.272|0.853|0.6895
71756701|NCT02085161|143016964|SUPERIORITY_OR_OTHER||Treatment ratio|1.128|STANDARD_ERROR_OF_MEAN|0.11||0.2188|TWO_SIDED|95.0|0.931|1.368||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.368|0.931|0.2188
71788895|NCT03336853|143075239|SUPERIORITY||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.66|0.82|||t-test, 2 sided|||||0.82|0.66|<.0001
71788896|NCT00667368|143075240|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.9||||0.754|TWO_SIDED|95.0|-12.0|10.1|||Two-sample test, Poisson||The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years.|||10.1|-12.0|0.754
71788897|NCT00667368|143075241|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71892366|NCT01381094|143306450|SUPERIORITY||||||=|0.0016|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0016
71892367|NCT01381094|143306450|SUPERIORITY||||||=|0.9697|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9697
71892368|NCT01381094|143306451|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=1.0000
71892369|NCT01381094|143306451|SUPERIORITY||||||=|0.0055|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0055
71892370|NCT01381094|143306451|SUPERIORITY||||||=|0.0009|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0009
71788898|NCT01911689|143075242|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the Control group and AP group.||||<0.01
71788899|NCT01911689|143075243|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2\* value between the edematous AP and necrotizing AP||||0.05
71788900|NCT01911689|143075244|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Analysis of variance (ANOVA) was used to assess the differences in the T2\* value between the mild, moderate, and severe AP groups according to the MRSI score.||||<0.01
71788901|NCT01911689|143075244|SUPERIORITY_OR_OTHER|||||||0.0111|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value in the mild and moderate AP according to MRSI||||0.0111
71788902|NCT01911689|143075244|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the mild and severe AP||||0.002
71788903|NCT01911689|143075244|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED|95.0|||||t-test, 2 sided|||compare the T2\* value between the moderate and severe AP according to MRSI||||0.071
71788904|NCT01911689|143075245|SUPERIORITY_OR_OTHER|||||||0.629|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.629
71788905|NCT01846611|143075291|SUPERIORITY||Hazard Ratio (HR)|0.925|||=|0.5236|TWO_SIDED|95.0|0.727|1.177|||Unstratified log rank test|||||1.177|0.727|= 0.5236
71788906|NCT01846611|143075292|SUPERIORITY||Hazard Ratio (HR)|0.935|||=|0.5174|TWO_SIDED|95.0|0.762|1.147|||Unstratified log rank test|||||1.147|0.762|= 0.5174
71788907|NCT01846611|143075293|SUPERIORITY||Odds Ratio (OR)|1.523|||=|0.0142|TWO_SIDED|95.0|1.075|2.158|||Fisher Exact|||||2.158|1.075|= 0.0142
71788908|NCT04772755|143075294|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
71788909|NCT04772755|143075295|SUPERIORITY|||||||0.8918|||||||Mantel Haenszel|||||||0.8918
71788910|NCT04772755|143075296|SUPERIORITY|||||||0.6587|||||||Wilcoxon (Mann-Whitney)|||||||0.6587
71788911|NCT04772755|143075297|SUPERIORITY|||||||0.0059|||||||Wilcoxon (Mann-Whitney)|||||||0.0059
71788912|NCT04772755|143075298|SUPERIORITY|||||||0.1647|||||||Chi-squared|||||||0.1647
71788913|NCT04772755|143075299|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.0090
71788914|NCT04772755|143075300|SUPERIORITY|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||||||0.0273
71788915|NCT04772755|143075301|SUPERIORITY|||||||0.0458|||||||Chi-squared|||||||0.0458
71788916|NCT04772755|143075302|SUPERIORITY|||||||0.0976|||||||Chi-squared|||||||0.0976
71788917|NCT01905657|143075307|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.54||||0.00024|TWO_SIDED|95.0|0.38|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.38|0.00024
71788918|NCT01905657|143075307|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.5||||2e-05|TWO_SIDED|95.0|0.36|0.7|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.70|0.36|0.00002
71788919|NCT01905657|143075307|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.71||||0.00076|TWO_SIDED|95.0|0.58|0.88|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.88|0.58|0.00076
71892371|NCT01381094|143306451|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.0002
71892372|NCT01381094|143306451|SUPERIORITY||||||=|0.9722|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 1).||||=0.9722
71892373|NCT01381094|143306451|SUPERIORITY||||||=|1|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=1.0000
71892374|NCT01381094|143306451|SUPERIORITY||||||=|0.0008|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0008
71671478|NCT00127231|142860216|EQUIVALENCE||Odds Ratio (OR)|0.42|||<|0.005|TWO_SIDED|95.0|0.23|0.75|||Mixed Models Analysis|||Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.||0.75|0.23|<0.005
71671479|NCT00191477|142860354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.946||||0.777||95.0|0.643|1.392||Only 87 recurrences and 7 deaths were documented at planned end of follow-up. The study was stopped early for futility reasons based on an interim analysis using pre-defined stopping boundaries for the hazard ratio (HR) of RFS.|Log Rank|||Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).||1.392|0.643|0.777
71671480|NCT01256450|142860388|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.587|TWO_SIDED|95.0|-0.646|0.366|||ANCOVA|||||0.366|-0.646|.5870
71671481|NCT03889418|142860420|SUPERIORITY||Odds Ratio, log|-0.009|STANDARD_ERROR_OF_MEAN|0.153||0.956|TWO_SIDED|95.0|-0.309|0.292|||Mixed Models Analysis|||||0.292|-0.309|0.956
71671482|NCT03889418|142860421|SUPERIORITY||Risk Ratio, log|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.039|TWO_SIDED|95.0|-0.2|-0.005|||Mixed Models Analysis|||||-.005|-0.200|0.039
71671483|NCT03889418|142860422|SUPERIORITY||Rate Ratio, log|0.049|STANDARD_ERROR_OF_MEAN|0.282||0.864|TWO_SIDED|95.0|-0.506|0.603|||Mixed Models Analysis|||||0.603|-0.506|0.864
71671484|NCT03889418|142860423|SUPERIORITY||rate ratio, log|0.018|STANDARD_ERROR_OF_MEAN|0.148||0.901|TWO_SIDED|95.0|-0.272|0.308|||Mixed Models Analysis|||||0.308|-0.272|0.901
71671485|NCT04760626|142860453|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec with doseguide minus once daily basal insulin analogue) was strictly below 0.3 percent point.|Treatment difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.09|||ANCOVA|||The response and change from baseline in response after 52 weeks were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors, and baseline HbA1c as a covariate.||-0.09|-0.66|<0.0001
71671486|NCT02946463|142860460|NON_INFERIORITY|LDH-N was analyzed using a generalized estimating equation (GEE) approach. The model included the following terms: treatment group, history of transfusion (as a categorical variable based on the stratification factor levels), and baseline LDH level (as a continuous variable). Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the odds ratio (OR) of ravulizumab versus eculizumab for LDH normalization being greater than an OR of 0.39.|Odds Ratio (OR)|1.187|||||TWO_SIDED|95.0|0.796|1.769||||||A minimum of 142 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab.||1.769|0.796|
71756702|NCT02085161|143016964|SUPERIORITY_OR_OTHER||Treatment ratio|1.241|STANDARD_ERROR_OF_MEAN|0.123||0.0303|TWO_SIDED|95.0|1.021|1.507||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.507|1.021|0.0303
71756703|NCT02085161|143016965|SUPERIORITY_OR_OTHER||LSMean Difference|-331.975|STANDARD_ERROR_OF_MEAN|296.375||0.2639|TWO_SIDED|95.0|-916.015|252.064||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||252.064|-916.015|0.2639
71756704|NCT02085161|143016965|SUPERIORITY_OR_OTHER||LSMean Difference|161.072|STANDARD_ERROR_OF_MEAN|293.506||0.5837|TWO_SIDED|95.0|-417.314|739.459||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||739.459|-417.314|0.5837
71756705|NCT02085161|143016965|SUPERIORITY_OR_OTHER||LSMean Difference|-524.926|STANDARD_ERROR_OF_MEAN|296.802||0.0783|TWO_SIDED|95.0|-1109.806|59.954||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||59.954|-1109.806|0.0783
71756706|NCT02085161|143016965|SUPERIORITY_OR_OTHER||LSMean Difference|-493.048|STANDARD_ERROR_OF_MEAN|289.566||0.09|TWO_SIDED|95.0|-1063.67|77.575||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||77.575|-1063.670|0.0900
71756707|NCT02085161|143016965|SUPERIORITY_OR_OTHER||LSMean Difference|685.998|STANDARD_ERROR_OF_MEAN|289.435||0.0186|TWO_SIDED|95.0|115.635|1256.362||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||1256.362|115.635|0.0186
71756708|NCT02085161|143016966|SUPERIORITY_OR_OTHER||LSMean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.5186|TWO_SIDED|95.0|-0.01|0.005||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.005|-0.010|0.5186
71756709|NCT02085161|143016966|SUPERIORITY_OR_OTHER||LSMean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.004||0.6436|TWO_SIDED|95.0|-0.006|0.009||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.009|-0.006|0.6436
71756710|NCT02085161|143016966|SUPERIORITY_OR_OTHER||LSMean Difference|-0.006|STANDARD_ERROR_OF_MEAN|0.004||0.1081|TWO_SIDED|95.0|-0.014|0.001||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.001|-0.014|0.1081
71837643|NCT03232138|143182116|EQUIVALENCE|2-sided P-value in the analysis, Mean (95%CI) changes from pre to pos treatment for positive cells. Caspase-3 all positive nuclei (counts/µm2) From Analysis of Covariance with adjustment for age, sex, cigarettes/day, years of smoking, years of quit smoking and baseline values of the same cellular biomarke||||||0.052||||||Hypothesis: Sulforaphane treatment has significant impact on the number of cells with positive Caspase-3 in bronchial biopsies than the placebo.|Analysis of Covariance|Analysis of Covariance adjustment for age,sex,cigarettes/day,years of smoking,years of quit smoking,baseline values of Caspase-3 positive cells||strong intensity positive nuclei. Mean (95%CI) changes from pre to pos treatment.||||0.052
71837644|NCT03232138|143182117|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. the objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RNA integrity number or RIN.|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.82|TWO_SIDED|||||Hypothesis: Sulforaphane treatment downregulate these genes whose over-expressions are associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.82
71837645|NCT03232138|143182118|EQUIVALENCE|This analysis was focused on the gene set that were found to be down-regulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated down-regulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-expressions are associated with lung cancer risk.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after 12-month sulforaphane treatment.|||||0.50
71837646|NCT03232138|143182119|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated upregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.15|STANDARD_ERROR_OF_MEAN|0.15||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate these genes whose over-expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
71837647|NCT03232138|143182120|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung pre-malignant lesions. The objective was to examine if sulforaphane treatment for 12 months would have any significant impact on the expression of these pre-malignant lesions associated downregulated genes in bronchial brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate these genes whose down-regulated expressions are associated with risk of lung pre-malignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.5
71837648|NCT03232138|143182121|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED|||||Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.012
71892375|NCT01381094|143306451|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0002
71756711|NCT02085161|143016966|SUPERIORITY_OR_OTHER||LSMean Difference|-0.004|STANDARD_ERROR_OF_MEAN|0.004||0.2612|TWO_SIDED|95.0|-0.011|0.003||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.003|-0.011|0.2612
71756712|NCT02085161|143016966|SUPERIORITY_OR_OTHER||LSMean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.004||0.0361|TWO_SIDED|95.0|0.001|0.015||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.015|0.001|0.0361
71756713|NCT02085161|143016967|SUPERIORITY_OR_OTHER||LSMean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.056||0.1727|TWO_SIDED|95.0|-0.034|0.187||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.187|-0.034|0.1727
71756714|NCT02085161|143016967|SUPERIORITY_OR_OTHER||LSMean Difference|0.143|STANDARD_ERROR_OF_MEAN|0.055||0.0097|TWO_SIDED|95.0|0.035|0.252||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.252|0.035|0.0097
71756715|NCT02085161|143016967|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.056||0.7815|TWO_SIDED|95.0|-0.095|0.126||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.126|-0.095|0.7815
71756716|NCT02085161|143016967|SUPERIORITY_OR_OTHER||LSMean Difference|-0.067|STANDARD_ERROR_OF_MEAN|0.054||0.2183|TWO_SIDED|95.0|-0.174|0.04||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.040|-0.174|0.2183
71756717|NCT02085161|143016967|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.055||0.0203|TWO_SIDED|95.0|0.02|0.236||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.236|0.020|0.0203
71756718|NCT02085161|143016968|SUPERIORITY_OR_OTHER||Treatment ratio|1.333|STANDARD_ERROR_OF_MEAN|0.142||0.0077|TWO_SIDED|95.0|1.08|1.645||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|||1.645|1.080|0.0077
71756719|NCT02085161|143016968|SUPERIORITY_OR_OTHER||Treatment ratio|1.244|STANDARD_ERROR_OF_MEAN|0.131||0.039|TWO_SIDED|95.0|1.011|1.53||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|||1.530|1.011|0.0390
71756720|NCT02085161|143016968|SUPERIORITY_OR_OTHER||Treatment ratio|1.051|STANDARD_ERROR_OF_MEAN|0.113||0.6452|TWO_SIDED|95.0|0.85|1.299||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|||1.299|0.850|0.6452
71756721|NCT02085161|143016968|SUPERIORITY_OR_OTHER||Treatment ratio|1.071|STANDARD_ERROR_OF_MEAN|0.111||0.5048|TWO_SIDED|95.0|0.874|1.313||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.|||1.313|0.874|0.5048
71756722|NCT02085161|143016968|SUPERIORITY_OR_OTHER||Treatment ratio|1.184|STANDARD_ERROR_OF_MEAN|0.123||0.1066|TWO_SIDED|95.0|0.964|1.453||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.|||1.453|0.964|0.1066
71756723|NCT02085161|143016969|SUPERIORITY_OR_OTHER||LSMean Difference|0.329|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.255|0.403||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.403|0.255|<0.0001
71756724|NCT02085161|143016969|SUPERIORITY_OR_OTHER||LSMean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.282|0.429||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.429|0.282|<0.0001
71756725|NCT02085161|143016969|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.099|0.249||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.249|0.099|<0.0001
71756726|NCT02085161|143016969|SUPERIORITY_OR_OTHER||LSMean Difference|-0.027|STANDARD_ERROR_OF_MEAN|0.037||0.4677|TWO_SIDED|95.0|-0.099|0.045||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.045|-0.099|0.4677
71756727|NCT02085161|143016969|SUPERIORITY_OR_OTHER||LSMean Difference|0.182|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.109|0.255||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.255|0.109|<0.0001
71756728|NCT02085161|143016970|SUPERIORITY_OR_OTHER||LSMean Difference|0.478|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|0.35|0.606||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.606|0.350|<0.0001
71756729|NCT02085161|143016970|SUPERIORITY_OR_OTHER||LSMean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|0.403|0.657||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.657|0.403|<0.0001
71756730|NCT02085161|143016970|SUPERIORITY_OR_OTHER||LSMean Difference|0.286|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.157|0.415||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.415|0.157|<0.0001
71756731|NCT02085161|143016970|SUPERIORITY_OR_OTHER||LSMean Difference|-0.052|STANDARD_ERROR_OF_MEAN|0.063||0.4107|TWO_SIDED|95.0|-0.176|0.072||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.072|-0.176|0.4107
71671487|NCT02946463|142860461|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|6.8|||||TWO_SIDED|95.0|-4.66|18.14|||||Treatment difference was estimated for ravulizumab - eculizumab.|A minimum of 193 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab. The difference of percentages were calculated using stratified Newcombe CI method. Stratification factors were: observed stratification groups of packed red blood cells (pRBC)/whole blood units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||18.14|-4.66|
71756732|NCT02085161|143016970|SUPERIORITY_OR_OTHER||LSMean Difference|0.244|STANDARD_ERROR_OF_MEAN|0.064||0.0002|TWO_SIDED|95.0|0.119|0.37||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.370|0.119|0.0002
71756733|NCT02085161|143016971|SUPERIORITY_OR_OTHER||LSMean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|0.179|0.457||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)|||0.457|0.179|<0.0001
71756734|NCT02085161|143016971|SUPERIORITY_OR_OTHER||LSMean Difference|0.302|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|0.165|0.439||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)|||0.439|0.165|<0.0001
71756735|NCT02085161|143016971|SUPERIORITY_OR_OTHER||LSMean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.071||0.0145|TWO_SIDED|95.0|0.035|0.314||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)|||0.314|0.035|0.0145
71756736|NCT02085161|143016971|SUPERIORITY_OR_OTHER||LSMean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.068||0.815|TWO_SIDED|95.0|-0.118|0.151||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM|||0.151|-0.118|0.8150
71756737|NCT02085161|143016971|SUPERIORITY_OR_OTHER||LSMean Difference|0.128|STANDARD_ERROR_OF_MEAN|0.069||0.0642|TWO_SIDED|95.0|-0.008|0.263||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM|||0.263|-0.008|0.0642
71756738|NCT03651479|143016991|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71756739|NCT02399163|143016997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.76|||<|0.0001|TWO_SIDED|95.0|11.061|22.454||From ANOVA: participant (random), treatment (fixed), period (fixed)|ANCOVA||Difference is Placebo dentifrice/Fluoride rinse minus Placebo dentifrice/No rinse such that a positive difference implies a larger response value for the Placebo dentifrice/Fluoride rinse.|||22.454|11.061|<0.0001
71788920|NCT01905657|143075307|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.61|||<|1e-05|TWO_SIDED|95.0|0.49|0.75|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.75|0.49|<0.00001
71788921|NCT01905657|143075308|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.58||||9e-05|TWO_SIDED|95.0|0.43|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.77|0.43|0.00009
71788922|NCT01905657|143075308|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.59||||7e-05|TWO_SIDED|95.0|0.45|0.78|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with strongly PD-L1 positive tumors||0.78|0.45|0.00007
71788923|NCT01905657|143075308|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.88||||0.06758|TWO_SIDED|95.0|0.73|1.04|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||1.04|0.73|0.06758
71671488|NCT02946463|142860462|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-6.7|||||TWO_SIDED|95.0|-14.21|0.18|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||0.18|-14.21|
71671489|NCT02946463|142860463|NON_INFERIORITY|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-0.83|||||TWO_SIDED|95.0|-5.21|3.56|||||Treatment difference was estimated for ravulizumab - eculizumab.|||3.56|-5.21|
71788924|NCT01905657|143075308|SUPERIORITY_OR_OTHER_LEGACY|Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.|Hazard Ratio (HR)|0.79||||0.00462|TWO_SIDED|95.0|0.66|0.94|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\^2|In participants with PD-L1 positive tumors||0.94|0.66|0.00462
71788925|NCT01905657|143075311|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|-2.3||||0.66608|TWO_SIDED|95.0|-12.7|8.2||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||8.2|-12.7|0.66608
71788926|NCT01905657|143075311|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|22.2|||<|1e-05|TWO_SIDED|95.0|14.0|30.7||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with strongly PD-L1 positive tumors||30.7|14.0|<0.00001
71671490|NCT02946463|142860464|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -5%.|Treatment difference|0.67|||||TWO_SIDED|95.0|-1.21|2.55|||||Treatment difference was estimated for ravulizumab - eculizumab.|||2.55|-1.21|
71671491|NCT02946463|142860465|NON_INFERIORITY|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|2.9|||||TWO_SIDED|95.0|-8.8|14.64|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.||14.64|-8.80|
71671492|NCT05691712|142860482|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-19.9|-12.36|||Mixed Models Analysis|||||-12.36|-19.9|<0.001
71671493|NCT05691712|142860482|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-19.7|-12.1|||Mixed Models Analysis|||||-12.10|-19.7|<0.001
71671494|NCT05691712|142860483|SUPERIORITY||LS Mean Difference|-13.06|||<|0.001|TWO_SIDED|95.0|-16.8|-9.34|||Mixed Models Analysis|||||-9.34|-16.8|<0.001
71671495|NCT05691712|142860484|SUPERIORITY||LS Mean Difference|-4.4|||<|0.001|TWO_SIDED|95.0|-5.8|-2.9|||Mixed Models Analysis|||||-2.9|-5.8|<0.001
71671496|NCT05691712|142860484|SUPERIORITY||LS Mean Difference|-6.5|||<|0.001|TWO_SIDED|95.0|-8.0|-5.0|||Mixed Models Analysis|||||-5.0|-8.0|<0.001
71671497|NCT05691712|142860484|SUPERIORITY||LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|95.0|-7.5|-4.5|||Mixed Models Analysis|||||-4.5|-7.5|<0.001
71671498|NCT05691712|142860486|SUPERIORITY||LS Mean Difference|-21.9|||<|0.001|TWO_SIDED|95.0|-32.4|-11.3|||Mixed Models Analysis|||||-11.3|-32.4|<0.001
71671499|NCT05691712|142860486|SUPERIORITY||LS Mean Difference|-28.9|||<|0.001|TWO_SIDED|95.0|-39.6|-18.1|||Mixed Models Analysis|||||-18.1|-39.6|<0.001
71788927|NCT01905657|143075311|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|8.7||||0.00045|TWO_SIDED|95.0|3.6|13.9||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||13.9|3.6|0.00045
71788928|NCT01905657|143075311|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|9.1||||0.00024|TWO_SIDED|95.0|4.1|14.3||P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.|Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen \& Nurminen method.|In participants with PD-L1 positive tumors||14.3|4.1|0.00024
71788929|NCT00157950|143075357|SUPERIORITY_OR_OTHER||Proportion|98.2|||||TWO_SIDED|95.0|93.6|99.8|||||Exact binomial confidence interval|||99.8|93.6|
71788930|NCT00157950|143075358|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|100.0|||||TWO_SIDED|95.0|96.8|100.0|||||Exact binomial confidence interval|||100|96.8|
71788931|NCT00157950|143075359|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.2|100.0|||||Exact binomial confidence interval|||100|95.2|
71788932|NCT00157950|143075360|NON_INFERIORITY_OR_EQUIVALENCE|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||TWO_SIDED|95.0|95.0|100.0|||||Exact binomial confidence interval|||100|95.0|
71671500|NCT05691712|142860486|SUPERIORITY||LS Mean Difference|-27.3|||<|0.001|TWO_SIDED|95.0|-38.2|-16.5|||Mixed Models Analysis|||||-16.5|-38.2|<0.001
71671501|NCT00204490|142860498|OTHER|||||||0.071|||||||t-test, 2 sided|||(FGBT% at 1 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.071
71671502|NCT00204490|142860498|OTHER|||||||0.08|||||||t-test, 2 sided|||(FGBT% at 2 year of treatment minus FGBT% at baseline) divided by FGBT% at baseline.||||0.080
71671503|NCT00204490|142860498|OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.045||0.019|TWO_SIDED||||||Regression, Linear|Mixed model|slope for interaction of treatment and time, placebo was the reference group; square root transformed outcome.|Intention to treat||||0.019
71671504|NCT04225715|142860505|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using Cochran-Mantel-Haenszel (CMH) method.|||16.4|-2.1|
71756740|NCT03594110|143017028|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0017 required at interim analysis."|Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|99.83|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|<0.0001
71788933|NCT02564042|143075380|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID has been presented|||76.6|25.9|
71788934|NCT02564042|143075380|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD has been presented|||73.2|22.2|
71788935|NCT02564042|143075380|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID has been presented|||60.5|6.3|
71788936|NCT02564042|143075380|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD has been presented|||55.9|1.6|
71892376|NCT01381094|143306451|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
71756741|NCT03594110|143017029|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0145 required at interim analysis."|Hazard Ratio (HR)|0.84||||0.1363|TWO_SIDED|98.55|0.63|1.12|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first hospitalization for heart failure or cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.12|0.63|0.1363
71756742|NCT03594110|143017030|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin. Two-sided significance level of \<0.0097 required at interim analysis.|Hazard Ratio (HR)|0.86||||0.0022|TWO_SIDED|99.03|0.76|0.98|||Joint frailty model||Comparison vs. Placebo|Hazard ratio (HR) of the time to occurrences of all-cause hospitalizations (first and recurrent combined). HR based on an analysis of recurrent events accounting for terminal events using a joint frailty model with terms for age, log(local screening UACR), local screening Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), treatment, sex, screening diabetes status, region.||0.98|0.76|0.0022
71756743|NCT03594110|143017031|SUPERIORITY|"Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.~Two-sided significance level of \<0.0290 required at interim analysis."|Hazard Ratio (HR)|0.87||||0.2122|TWO_SIDED|97.1|0.68|1.11|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to death from any cause. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||1.11|0.68|0.2122
71756744|NCT03594110|143017032|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.81|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.81|0.62|<0.0001
71756745|NCT03594110|143017033|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.83||||0.2932|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to cardiovascular death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||1.17|0.59|0.2932
71756746|NCT03594110|143017034|SUPERIORITY|Null hypothesis: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.72||||0.0017|TWO_SIDED|95.0|0.59|0.89|||Regression, Cox||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence cardiovascular death or end stage kidney disease (ESKD). HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.89|0.59|0.0017
71788937|NCT02564042|143075381|OTHER||Proportion difference|2.9|||||TWO_SIDED|95.0|-21.0|26.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented|||26.6|-21.0|
71788938|NCT02564042|143075381|OTHER||Proportion difference|6.3||||||95.0|-20.5|32.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||32.4|-20.5|
71788939|NCT02564042|143075381|OTHER||Proportion difference|15.2|||||TWO_SIDED|95.0|-9.6|39.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented|||39.1|-9.6|
71788940|NCT02564042|143075381|OTHER||Proportion difference|3.3|||||TWO_SIDED|95.0|-23.6|29.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented|||29.9|-23.6|
71788941|NCT02564042|143075381|OTHER||Proportion difference|3.1|||||TWO_SIDED|95.0|-22.2|28.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||28.1|-22.2|
71788942|NCT02564042|143075381|OTHER||Proportion difference|27.6|||||TWO_SIDED|95.0|-0.5|52.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||52.4|-0.5|
71788943|NCT02564042|143075381|OTHER||Proportion difference|25.8|||||TWO_SIDED|95.0|-0.4|49.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented|||49.3|-0.4|
71671505|NCT04225715|142860505|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|||10|-3.1|
71671506|NCT04225715|142860505|SUPERIORITY||Difference in Response Rate|24.3|||||TWO_SIDED|95.0|9.0|39.5|||||95% CI for difference of two proportions was calculated using CMH method.|||39.5|9|
71756747|NCT03594110|143017035|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression or CV death. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening Urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
71756748|NCT03594110|143017036|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.72|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of kidney disease progression. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.72|
71756749|NCT03594110|143017037|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.72|0.9|||||Comparison vs. Placebo|Hazard ratio (HR) of the time to first occurrence of death from any cause or ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.90|0.72|
71756750|NCT03594110|143017038|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.87|||||Comparison vs. Placebo|Hazard ratio (HR) of ESKD. HR is based on a Cox regression model with terms for age, sex, screening diabetes status, local screening estimated glomerular filtration rate Chronic Kidney Disease Epidemiology Collaboration (eGFR (CKD-EPI)), local screening urine albumin-to-creatinine ratio (UACR), region and treatment.||0.87|0.64|
71756751|NCT03594110|143017039|OTHER||Mean Difference (Net)|-0.24|||<|0.001|TWO_SIDED|95.0|-0.38|-0.11|||Mixed Models Analysis||\[Comparator\] - \[Placebo\]|A mixed model of repeated measures (MMRM) with terms for baseline, age, sex, screening diabetes status, local screening eGFR, local screening UACR, treatment, treatment-by-time interaction and baseline-by-time interaction.||-0.11|-0.38|< 0.001
71756752|NCT03594110|143017040|OTHER||Mean Difference (Net)|-12.0||||0.41|TWO_SIDED|95.0|-42.0|17.0|||Regression, Linear||\[Comparator\]-\[Placebo\]|Differences in MRI measurements between treatment groups were assessed using a linear regression with terms for age, sex, screening diabetes status, local screening eGFR, local screening UACR was used in the analysis.||17|-42|0.41
71756753|NCT00684021|143017060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|2.0||0.959|TWO_SIDED|95.0|-4.1|3.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||3.9|-4.1|0.959
71756754|NCT00684021|143017061|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.93|TWO_SIDED|95.0|0.42|2.23|||Fisher Exact|||Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.||2.23|0.42|0.93
71756755|NCT00684021|143017062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|4.8||0.585|TWO_SIDED|95.0|-12.2|6.9|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||6.9|-12.2|0.585
71756756|NCT00684021|143017063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|3.7||0.831|TWO_SIDED|95.0|-6.6|8.2|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||8.2|-6.6|0.831
71756757|NCT00684021|143017064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|3.7||0.817|TWO_SIDED|95.0|-5.5|7.0|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||7.0|-5.5|0.817
71756758|NCT00684021|143017065|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|4.27||0.272|TWO_SIDED|95.0|-13.7|3.67|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.||3.67|-13.7|0.272
71788944|NCT02564042|143075381|OTHER||Proportion difference|9.2|||||TWO_SIDED|95.0|-18.4|35.7|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||35.7|-18.4|
71788945|NCT02564042|143075381|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.7|31.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented|||31.7|-19.7|
71788946|NCT02564042|143075381|OTHER||Proportion difference|45.0|||||TWO_SIDED|95.0|16.6|68.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||68.4|16.6|
71756759|NCT00684021|143017066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.1||0.409|TWO_SIDED|95.0|-3.0|1.2|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||1.2|-3.0|0.409
71788947|NCT02564042|143075381|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
71788948|NCT02564042|143075381|OTHER||Proportion difference|32.0|||||TWO_SIDED|95.0|3.5|57.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented|||57.2|3.5|
71788949|NCT02564042|143075381|OTHER||Proportion difference|34.4|||||TWO_SIDED|95.0|6.3|58.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented|||58.7|6.3|
71788950|NCT02564042|143075381|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented|||72.4|20.1|
71788951|NCT02564042|143075381|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
71788952|NCT02564042|143075381|OTHER||Proportion difference|30.4|||||TWO_SIDED|95.0|1.0|56.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||56.1|1.0|
71892377|NCT01381094|143306451|SUPERIORITY||||||=|0.6579|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6579
71671507|NCT04225715|142860505|SUPERIORITY||Difference in Response Rate|12.3|||||TWO_SIDED|95.0|1.3|23.3|||||95% CI for difference of two proportions was calculated using CMH method.|||23.3|1.3|
71756760|NCT00684021|143017066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|100.0|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|15.0|1000.0|||Regression, Linear|||||1000|15|0.02
71756761|NCT00684021|143017067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.777|TWO_SIDED|95.0|-3.9|2.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.||||2.9|-3.9|0.777
71756762|NCT01598532|143017079|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.004
71756763|NCT01598532|143017080|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments||||<0.003
71756764|NCT01598532|143017081|SUPERIORITY_OR_OTHER||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for effect of LED treatments||||<0.003
71756765|NCT01598532|143017082|SUPERIORITY_OR_OTHER||||||<|0.006|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effects of LED treatments||||<0.006
71756766|NCT00728689|143017155|SUPERIORITY_OR_OTHER|||||||0.4591|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.4591
71756767|NCT00728689|143017156|SUPERIORITY_OR_OTHER|||||||0.0048|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-τ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0048
71756768|NCT00728689|143017157|SUPERIORITY_OR_OTHER|||||||0.0997|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-∞ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0997
71756769|NCT00728689|143017158|SUPERIORITY_OR_OTHER|||||||0.0422|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, Cmax was analyzed on a log scale, to assess bioequivalence between Form I and Form V.||||0.0422
71756770|NCT00728689|143017159|SUPERIORITY_OR_OTHER|||||||0.8581|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.||||0.8581
71756771|NCT01867671|143017160|SUPERIORITY||Odds Ratio (OR)|205.45|||<|0.0001|TWO_SIDED|95.0|24.0|1758.51|||Regression, Logistic|||||1758.51|24.00|<0.0001
71756772|NCT01867671|143017161|SUPERIORITY||Odds Ratio (OR)|27.82|||<|0.0031|TWO_SIDED|95.0|3.07|252.33|||Regression, Logistic|||||252.33|3.07|<0.0031
71756773|NCT01867671|143017162|OTHER|McNemar's Test|Simple Kappa Coefficient|0.162|||<|0.0001|TWO_SIDED|95.0|0.0628|0.2612|||McNemar|||||0.2612|0.0628|<0.0001
71671508|NCT04225715|142860505|SUPERIORITY||Difference in Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||95% CI for difference of two proportions was calculated using CMH method.|||0|0|
71756774|NCT01867671|143017163|SUPERIORITY||Mean Difference (Final Values)|1464.0|||<|0.0001|TWO_SIDED|95.0|944.0|1985.0|||Chi-squared|||||1985|944|<0.0001
71756775|NCT01523366|143017165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-167.2|STANDARD_ERROR_OF_MEAN|14.6|<|0.001|TWO_SIDED|95.0|-197.0|-137.4|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|||-137.4|-197.0|<.001
71756776|NCT01523366|143017166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.2|STANDARD_ERROR_OF_MEAN|18.23|<|0.001|TWO_SIDED|95.0|-172.3|-98.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 0.5 hours after the loading dose||-98.0|-172.3|<.001
71756777|NCT01523366|143017166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-168.9|STANDARD_ERROR_OF_MEAN|17.28|<|0.001|TWO_SIDED|95.0|-204.0|-133.7|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 8 hours after the loading dose||-133.7|-204.0|<.001
71788953|NCT02564042|143075381|OTHER||Proportion difference|41.4|||||TWO_SIDED|95.0|12.7|65.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||65.0|12.7|
71788954|NCT02564042|143075381|OTHER||Proportion difference|49.4|||||TWO_SIDED|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||72.4|20.1|
71756778|NCT01523366|143017167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-150.5|STANDARD_ERROR_OF_MEAN|12.97|<|0.001|TWO_SIDED|95.0|-176.9|-124.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-124.1|-176.9|<.001
71788955|NCT02564042|143075381|OTHER||Proportion difference|60.1|||||TWO_SIDED|95.0|33.2|80.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||80.1|33.2|
71788956|NCT02564042|143075381|OTHER||Proportion difference|30.0|||||TWO_SIDED|95.0|0.2|56.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||56.5|0.2|
71788957|NCT02564042|143075381|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|14.4|66.5|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||66.5|14.4|
71788958|NCT02564042|143075381|OTHER||Proportion difference|52.0|||||TWO_SIDED|95.0|23.2|74.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||74.4|23.2|
71892378|NCT01381094|143306451|SUPERIORITY||||||=|0.4102|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.4102
71892379|NCT01381094|143306451|SUPERIORITY||||||=|0.0023|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0023
71671509|NCT04225715|142860505|SUPERIORITY||Difference in Response Rate|6.7|||||TWO_SIDED|95.0|-2.2|15.7|||||95% CI for difference of two proportions was calculated using CMH method.|||15.7|-2.2|
71788959|NCT02564042|143075381|OTHER||Proportion difference|52.4|||||TWO_SIDED|95.0|24.4|74.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||74.0|24.4|
71788960|NCT02564042|143075381|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||60.5|6.3|
71788961|NCT02564042|143075381|OTHER||Proportion difference|48.3|||||TWO_SIDED|95.0|19.7|71.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||71.1|19.7|
71788962|NCT02564042|143075381|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
71788963|NCT02564042|143075381|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
71788964|NCT02564042|143075390|OTHER||Proportion difference|-3.6|||||TWO_SIDED|95.0|-28.8|21.9|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented|||21.9|-28.8|
71788965|NCT02564042|143075390|OTHER||Proportion difference|-0.3|||||TWO_SIDED|95.0|-25.4|25.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented|||25.1|-25.4|
71788966|NCT02564042|143075390|OTHER||Proportion difference|9.4|||||TWO_SIDED|95.0|-17.5|35.3|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented|||35.3|-17.5|
71892380|NCT01381094|143306451|SUPERIORITY||||||=|0.0052|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0052
71671510|NCT04225715|142860506|SUPERIORITY||6.2|6.2|||||TWO_SIDED|95.0|-2.0|14.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 7: Week 24||14.5|-2|
71788967|NCT02564042|143075390|OTHER||Proportion difference|9.1|||||TWO_SIDED|95.0|-15.4|33.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .|||33.3|-15.4|
71788968|NCT02564042|143075390|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-17.1|36.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .|||36.1|-17.1|
71788969|NCT02564042|143075390|OTHER||Proportion difference|6.3|||||TWO_SIDED|95.0|-19.3|31.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented|||31.0|-19.3|
71788970|NCT02564042|143075390|OTHER||Proportion difference|9.7|||||TWO_SIDED|95.0|-18.2|36.7|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented|||36.7|-18.2|
71788971|NCT02564042|143075390|OTHER||Proportion difference|19.4|||||TWO_SIDED|95.0|-6.9|43.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .|||43.6|-6.9|
71788972|NCT02564042|143075390|OTHER||Proportion difference|12.7|||||TWO_SIDED|95.0|-15.1|38.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented|||38.9|-15.1|
71788973|NCT02564042|143075390|OTHER||Proportion difference|12.5|||||TWO_SIDED|95.0|-13.6|37.4|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .|||37.4|-13.6|
71788974|NCT02564042|143075390|OTHER||Proportion difference|42.3|||||TWO_SIDED|95.0|13.8|66.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented|||66.0|13.8|
71788975|NCT02564042|143075390|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented|||61.3|8.7|
71788976|NCT02564042|143075390|OTHER||Proportion difference|33.3|||||TWO_SIDED|95.0|4.8|58.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .|||58.2|4.8|
71788977|NCT02564042|143075390|OTHER||Proportion difference|40.6|||||TWO_SIDED|95.0|12.8|63.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.|||63.9|12.8|
71788978|NCT02564042|143075390|OTHER||Proportion difference|54.7|||||TWO_SIDED|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.|||76.6|25.9|
71788979|NCT02564042|143075390|OTHER||Proportion difference|51.0|||||TWO_SIDED|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented|||73.2|22.2|
71788980|NCT02564042|143075390|OTHER||Proportion difference|35.6|||||TWO_SIDED|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented|||60.5|6.3|
71788981|NCT02564042|143075390|OTHER||Proportion difference|30.7|||||TWO_SIDED|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented|||55.9|1.6|
71788982|NCT02564042|143075390|OTHER||Proportion difference|51.3|||||TWO_SIDED|95.0|22.0|74.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented|||74.0|22.0|
71788983|NCT02564042|143075390|OTHER||Proportion difference|61.5|||||TWO_SIDED|95.0|34.6|81.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented|||81.0|34.6|
71892381|NCT01381094|143306451|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0017
71892382|NCT01381094|143306451|SUPERIORITY||||||=|0.7378|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7378
71892383|NCT01381094|143306451|SUPERIORITY||||||=|0.3371|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3371
71671511|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|13.4|||||TWO_SIDED|95.0|1.2|25.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 8: Week 36||25.6|1.2|
71671512|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|7.2|||||TWO_SIDED|95.0|-2.1|16.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: Week 48||16.4|-2.1|
71671513|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|3.5|||||TWO_SIDED|95.0|-3.1|10.0|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: Week 48||10|-3.1|
71788984|NCT02564042|143075390|OTHER||Proportion difference|23.9|||||TWO_SIDED|95.0|-6.1|51.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented|||51.0|-6.1|
71788985|NCT02564042|143075390|OTHER||Proportion difference|37.0|||||TWO_SIDED|95.0|7.8|61.6|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented|||61.6|7.8|
71788986|NCT02564042|143075390|OTHER||Proportion difference|53.1|||||TWO_SIDED|95.0|24.7|75.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented|||75.6|24.7|
71788987|NCT02564042|143075390|OTHER||Proportion difference|53.8|||||TWO_SIDED|95.0|25.8|75.5|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented|||75.5|25.8|
71788988|NCT02564042|143075390|OTHER||Proportion difference|29.4|||||TWO_SIDED|95.0|-0.3|55.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented|||55.0|-0.3|
71788989|NCT02564042|143075390|OTHER||Proportion difference|35.7|||||TWO_SIDED|95.0|6.5|60.2|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented|||60.2|6.5|
71788990|NCT02564042|143075390|OTHER||Proportion difference|10.0|||||TWO_SIDED|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented|||53.9|-36.9|
71788991|NCT02564042|143075390|OTHER||Proportion difference|42.9|||||TWO_SIDED|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented|||81.6|-6.3|
71671514|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|31.2|||||TWO_SIDED|95.0|14.7|47.6|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: Week 48||47.6|14.7|
71671515|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|18.4|||||TWO_SIDED|95.0|5.4|31.4|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: Week 48||31.4|5.4|
71788992|NCT02564042|143075390|OTHER||Proportion difference|25.0|||||TWO_SIDED|95.0|-35.7|80.6|||||Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented|||80.6|-35.7|
71671516|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|8.1|||||TWO_SIDED|95.0|-3.9|20.1|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 2: FUW 48||20.1|-3.9|
71671517|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|-2.7|||||TWO_SIDED|95.0|-8.1|2.7|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 3: FUW 48||2.7|-8.1|
71671518|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|14.6|||||TWO_SIDED|95.0|0.4|28.8|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 4: FUW 48||28.8|0.4|
71671519|NCT04225715|142860506|SUPERIORITY||Difference in Response Rate|9.5|||||TWO_SIDED|95.0|-2.5|21.5|||||95% CI for difference of two proportions was calculated using CMH method.|Combo 6: FUW 48||21.5|-2.5|
71671520|NCT05251337|142860530|SUPERIORITY|||||||0.462|||||||Mixed Models Analysis|||||||0.462
71671521|NCT05251337|142860531|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||||||0.285
71788993|NCT00303498|143075440|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|43.0||||0.0302|||||||ANCOVA|Change at Week 24: P-value was obtained from the non-parametric analysis of covariance (ANCOVA) controlling for baseline treadmill exercise time.||The median of the treatment difference was calculated using the Hodges-Lehmann estimator.||||0.0302
71788994|NCT00303498|143075441|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.495|||||||ANCOVA|Change at Week 24: P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.4950
71788995|NCT00303498|143075442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.6||||0.3874|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PLAX 2D mode||||0.3874
71788996|NCT00303498|143075442|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.8||||0.7038|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||Change at Week 24 for PSAX M-mode||||0.7038
71788997|NCT00303498|143075443|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.9||||0.8998|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8998
71788998|NCT00303498|143075444|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7||||0.7245|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.7245
71788999|NCT00303498|143075445|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5||||0.8649|||||||ANCOVA|P-value was calculated from an ANCOVA with effect for treatment and baseline value as a covariate.||||||0.8649
71789000|NCT00303498|143075446|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5909||||||The statistical analysis (P value) was performed on the composite change for all categories.|Cochran-Mantel-Haenszel|||Change at Week 24||||0.5909
71789001|NCT02289898|143075450|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.7158|TWO_SIDED|95.0|0.63|1.375|||Wilcoxon (Mann-Whitney)|||Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.||1.375|0.630|=0.7158
71789002|NCT01493570|143075451|OTHER||Ratio CSF to Plasma in %|28.31||||1|TWO_SIDED|90.0|25.418|31.532||p-value for ratio outside interval 80% - 125%|ANOVA||Intra Individual geometric coefficient of variation (gCV \[%\]) = 17.50 .|Dose-adjusted CSF to plasma ratio for Cmax. The Analysis of Variance (ANOVA) model was used with 'subject nested within treatment' considered as random effect.||31.532|25.418|1.0000
71789003|NCT02598076|143075465|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
71789004|NCT02598076|143075466|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||||||0.034
71789005|NCT02598076|143075467|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71789006|NCT02598076|143075468|SUPERIORITY|||||||0.095|||||||Fisher Exact|||||||0.095
71789007|NCT02598076|143075469|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71671522|NCT05251337|142860533|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
71671523|NCT00471081|142860545|SUPERIORITY||Percentage of subjects with hSBA titers|88.4|||||TWO_SIDED|95.0|81.9|93.2|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.||93.2|81.9|
71789008|NCT02611778|143075475|EQUIVALENCE|The confidence interval (CI) for treatment difference (FYB201 - Lucentis) was calculated using Least Square Means. If the 90% CI was completely contained in the interval \]-3.5;3.5\[ ETDRS letters, equivalence of FYB201 and Lucentis could be concluded.|Difference in least square means|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.6|0.9|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|The hypothesis of biosimilarity of FYB201 and Lucentis was tested with a two-sided equivalence test with an equivalence margin of 3 ETDRS letters. An ANCOVA model was used with the change in BCVA between baseline and Week 8 as the dependent variable, the baseline BCVA as covariate, and the country and the treatment group as fixed effects.||0.9|-1.6|
71789009|NCT02611778|143075476|OTHER||Difference in least square means|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.6|1.5|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 24 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.5|-1.6|
71789010|NCT02611778|143075477|OTHER||Difference in least square means|-0.1|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-1.8|1.7|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and Week 48 as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.7|-1.8|
71789011|NCT02611778|143075478|OTHER||Difference in least square means|0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.6|1.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in BCVA between baseline and 12 months (average of Weeks 40, 44 and 48) as the dependent variable, the baseline BCVA as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.8|-1.6|
71789012|NCT02611778|143075479|OTHER||Difference in least square means|0.69|STANDARD_ERROR_OF_MEAN|11.469|||TWO_SIDED|90.0|-18.22|19.6|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||19.60|-18.22|
71789013|NCT02611778|143075480|OTHER||Difference in least square means|2.68|STANDARD_ERROR_OF_MEAN|11.632|||TWO_SIDED|90.0|-16.49|21.85|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCP retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCP retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||21.85|-16.49|
71789014|NCT02611778|143075481|OTHER||Difference in least square means|-5.91|STANDARD_ERROR_OF_MEAN|10.136|||TWO_SIDED|90.0|-22.62|10.8|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 24 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||10.80|-22.62|
71789015|NCT02611778|143075482|OTHER||Difference in least square means|3.68|STANDARD_ERROR_OF_MEAN|10.285|||TWO_SIDED|90.0|-13.28|20.63|||ANCOVA||An ANCOVA model was used for the analysis with the change in FCS retinal thickness between baseline and Week 48 as the dependent variable, the baseline FCS retinal thickness as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||20.63|-13.28|
71789016|NCT02611778|143075483|OTHER||Difference in least square means|0.07|STANDARD_ERROR_OF_MEAN|0.4709|||TWO_SIDED|90.0|-0.706|0.846|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 24 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||0.846|-0.706|
71789017|NCT02611778|143075484|OTHER||Difference in least square means|0.342|STANDARD_ERROR_OF_MEAN|0.5387|||TWO_SIDED|90.0|-0.547|1.23|||ANCOVA||An ANCOVA model was used for the analysis with the change in total lesion area between baseline and Week 48 as the dependent variable, the baseline total lesion area as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.230|-0.547|
71789018|NCT02611778|143075485|OTHER||Difference in least square means|0.21|STANDARD_ERROR_OF_MEAN|0.886|||TWO_SIDED|90.0|-1.25|1.67|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 24 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||1.67|-1.25|
71789019|NCT02611778|143075486|OTHER||Difference in least square means|1.73|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|90.0|0.04|3.42|||ANCOVA||An ANCOVA model was used for the analysis with change in NEI VFQ-25 composite score between baseline and Week 48 as dependent variable, baseline NEI VFQ-25 composite score as covariate, and (pooled) country and treatment group as fixed effects.|There was no formal hypothesis testing.||3.42|0.04|
71789020|NCT00770289|143075511|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.899|||<|0.0001|TWO_SIDED|95.0|0.886|0.911||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.911|0.886|<0.0001
71892384|NCT01381094|143306451|SUPERIORITY||||||=|0.0916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0916
71789021|NCT00770289|143075511|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.797|||<|0.0001|TWO_SIDED|95.0|0.771|0.82||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.820|0.771|<0.0001
71892385|NCT01381094|143306451|SUPERIORITY||||||=|0.4656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4656
71892386|NCT01381094|143306451|SUPERIORITY||||||=|0.1629|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1629
71892387|NCT01381094|143306451|SUPERIORITY||||||=|0.7032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.7032
71892388|NCT01381094|143306451|SUPERIORITY||||||=|0.5194|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5194
71892389|NCT01381094|143306451|SUPERIORITY||||||=|0.8516|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8516
71671524|NCT00471081|142860545|SUPERIORITY||Percentage of subjects with hSBA titers|100.0|||||TWO_SIDED|95.0|97.3|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 90%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.||100|97.3|
71789022|NCT00770289|143075511|SUPERIORITY_OR_OTHER||Pearson's correlation coefficient|0.765|||<|0.0001|TWO_SIDED|95.0|0.736|0.791||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.||0.791|0.736|<0.0001
71789023|NCT02956486|143075513|SUPERIORITY||Least Square (LS) Mean Difference|-0.17||||0.385|TWO_SIDED|95.0|-0.57|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (mild cognitive impairment \[MCI\]/Prodromal, mild alzheimer's disease \[AD\]), concurrent AD medication use, region, apolipoprotein E (ApoE4) status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.57|0.385
71789024|NCT02956486|143075515|SUPERIORITY||LS Mean Difference|-0.02||||0.345|TWO_SIDED|95.0|-0.06|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.06|0.345
71789025|NCT02956486|143075516|SUPERIORITY||LS Mean Difference|-12.83|||<|0.001|TWO_SIDED|95.0|-18.79|-6.88|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||-6.88|-18.79|<.001
71789026|NCT02956486|143075517|SUPERIORITY||LS Mean Difference|-0.23||||0.316|TWO_SIDED|95.0|-0.67|0.22|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.22|-0.67|0.316
71789027|NCT02956486|143075518|SUPERIORITY||LS Mean Difference|-0.03||||0.254|TWO_SIDED|95.0|-0.07|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.02|-0.07|0.254
71789028|NCT02956486|143075519|SUPERIORITY||Difference of Mean Slope|-0.008||||0.9088|TWO_SIDED|95.0|-0.145|0.129|||Linear mixed effects model|||Based on the linear mixed effects model, which included assessment time and treatment group by assessment time interaction as covariate with random intercept and slope.||0.129|-0.145|0.9088
71789029|NCT02956486|143075520|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6155|TWO_SIDED|95.0|0.77|1.16|||Regression, Cox|||Based on a Cox regression model which included treatment group, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.16|0.77|0.6155
71789030|NCT02956486|143075521|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.1281|TWO_SIDED|95.0|0.96|1.35|||Regression, Cox|||Based on a Cox regression model which included treatment group, concurrent AD medication use, region, APOE4 status (positive, negative) as covariate.||1.35|0.96|0.1281
71789031|NCT02956486|143075522|SUPERIORITY||LS Mean Difference|-0.43||||0.525|TWO_SIDED|95.0|-1.75|0.9|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.90|-1.75|0.525
71789032|NCT02956486|143075523|SUPERIORITY||LS Mean Difference|-0.01||||0.977|TWO_SIDED|95.0|-0.64|0.62|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.62|-0.64|0.977
71789033|NCT02956486|143075524|SUPERIORITY||LS Mean Difference|0.11||||0.854|TWO_SIDED|95.0|-1.09|1.32|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.32|-1.09|0.854
71756779|NCT01523366|143017167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-140.2|STANDARD_ERROR_OF_MEAN|13.84|<|0.001|TWO_SIDED|95.0|-168.4|-111.9|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at 8 hours on Day 7 after multiple doses||-111.9|-168.4|<.001
71789034|NCT02956486|143075525|SUPERIORITY||LS Mean Difference|-0.27||||0.314|TWO_SIDED|95.0|-0.79|0.26|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||0.26|-0.79|0.314
71789035|NCT02956486|143075526|SUPERIORITY||LS Mean Difference|0.07||||0.895|TWO_SIDED|95.0|-0.93|1.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value and the baseline value by visit interaction as covariate.||1.07|-0.93|0.895
71789036|NCT02956486|143075527|SUPERIORITY||LS Mean Difference|0.04||||0.542|TWO_SIDED|95.0|-0.09|0.17|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.17|-0.09|0.542
71789037|NCT02956486|143075528|SUPERIORITY||LS Mean Difference|-0.01||||0.38|TWO_SIDED|95.0|-0.02|0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.01|-0.02|0.380
71789038|NCT02956486|143075529|SUPERIORITY||LS Mean Difference|-0.4||||0.063|TWO_SIDED|95.0|-0.82|0.02|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.02|-0.82|0.063
71789039|NCT02956486|143075530|SUPERIORITY||LS Mean Difference|-0.56||||0.045|TWO_SIDED|95.0|-1.11|-0.01|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.01|-1.11|0.045
71789040|NCT02956486|143075531|SUPERIORITY||LS Mean Difference|-0.04||||0.799|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||0.24|-0.32|0.799
71789041|NCT02956486|143075532|SUPERIORITY||LS Mean Difference|-0.32||||0.012|TWO_SIDED|95.0|-0.56|-0.07|||MMRM|||Analysis was based on the MMRM and factors for treatment group, visit, treatment group by visit interaction, clinical disease staging (MCI/Prodromal, mild AD), concurrent AD medication use, region, ApoE4 status (positive, negative) as fixed effects, and the baseline value as covariate.||-0.07|-0.56|0.012
71789042|NCT00345254|143075549|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71671525|NCT00471081|142860545|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.||100|96.2|
71756780|NCT01523366|143017167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-130.6|STANDARD_ERROR_OF_MEAN|13.41|<|0.001|TWO_SIDED|95.0|-158.0|-103.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at end of dosing interval on Day 8||-103.2|-158.0|<.001
71789043|NCT02663232|143075625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage (IIIC \[referral category\] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.001
71789044|NCT02663232|143075625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIC/M1a/M1b \[referral category\] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.196
71789045|NCT02663232|143075625|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||||0.002
71789046|NCT02663232|143075625|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.716||||0.028|TWO_SIDED|95.0|1.115|6.616|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||6.616|1.115|0.028
71789047|NCT02663232|143075625|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.466||||0.142|TWO_SIDED|95.0|0.168|1.291|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.291|0.168|0.142
71892390|NCT01381094|143306451|SUPERIORITY||||||=|0.0017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0017
71756781|NCT00929695|143017191|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71756782|NCT00929695|143017191|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.4
71756783|NCT00929695|143017199|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.14|1.33||||||||1.33|0.14|
71837649|NCT03232138|143182122|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung cancer. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these lung-cancer associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.38|STANDARD_ERROR_OF_MEAN|0.12||0.0045|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in nasal epithelial cells have been found to be associated with risk of lung cancer.|Mixed Models Analysis||Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.0045
71837650|NCT03232138|143182123|EQUIVALENCE|This analysis was focused on the gene set that were found to be upregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated upregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would downregulate the expression of these genes whose upregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.32
71837651|NCT03232138|143182124|EQUIVALENCE|This analysis was focused on the gene set that were found to be downregulated in lung premalignant lesions. The objective was to examine if sulforaphane treatment for 12 months had any significant impact on the expression of these premalignant lesion-associated downregulated genes in nasal brushing samples. A linear mixed model was used to evaluate the effect of sulforaphane treatment over time on GSVA enrichment score with adjustment for age at study entry, sex, and RIN.|Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.14||0.27|TWO_SIDED|||||Hypothesis: Sulforaphane treatment would upregulate the expression of these genes whose downregulated expressions in bronchial epithelial cells have been found to be associated with risk of lung premalignant lesions.|Mixed Models Analysis|The model includes treatment, time, time\*treatment, age at study entry, sex, and RIN.|Changes (beta) of gene expression after the 12-month sulforaphane treatment.|||||0.27
71837652|NCT03232138|143182125|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.59||||||For severity by treatment group.|Fisher Exact|||||||0.590
71837653|NCT03232138|143182125|EQUIVALENCE|Total number of adverse events by attrition and severity by treatment group during the study period, The Pittsburgh Clinical Trial of Sulforaphane (SFN) on Risk Markers of Lung Cancer||||||0.131||||||For attribution by treatment group.|Fisher Exact|||||||0.131
71837654|NCT05260684|143182151|OTHER||Hazard Ratio (HR)|1.32||||0.02|TWO_SIDED|95.0|1.05|1.65|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.65|1.05|0.02
71837655|NCT05260684|143182151|OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.79|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.79|0.76|0.47
71892391|NCT01381094|143306451|SUPERIORITY||||||=|0.0656|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0656
71837656|NCT05260684|143182152|OTHER||Hazard Ratio (HR)|1.49|||<|0.001|TWO_SIDED|95.0|1.2|1.87|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Dabrafenib+Trametinib relative to Encorafenib+Binimetinib (reference).||1.87|1.20|<0.001
71892392|NCT01381094|143306451|SUPERIORITY||||||=|0.6495|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6495
71756784|NCT00929695|143017200|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.009|TWO_SIDED|95.0|0.12|0.74|||Regression, Cox|||||0.74|0.12|0.009
71837657|NCT05260684|143182152|OTHER||Hazard Ratio (HR)|1.2||||0.4|TWO_SIDED|95.0|0.79|1.82|||Wald Chi- Square Statistic||HR was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Vemurafenib + Cobimetinib relative to Encorafenib+Binimetinib (reference).||1.82|0.79|0.40
71837658|NCT03519581|143182169|OTHER|The primary statistical analysis was an intention-to-treat analysis. The primary outcome was analyzed by Kruskal-Wallis test because the data was non-parametric.||||||0.76|||||||Kruskal-Wallis|||The target sample size for the study was 30 eyes, based on power calculations to achieve 80% power assuming 40% of sham-treated eyes will reach the vision loss threshold within 2 years, while SML treatment will reduce that value to 15%, using a 2:1 ratio for randomization (2 treatment : 1 sham).||||.76
71837659|NCT03519581|143182170|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||.16
71837660|NCT03519581|143182171|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
71837661|NCT03519581|143182172|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||.68
71837662|NCT03519581|143182173|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
71837663|NCT03519581|143182174|SUPERIORITY|Two-tailed t-tests and mixed effects regression models||||||0.5|||||||t-test, 2 sided|||||||.50
71837664|NCT03850678|143182268|SUPERIORITY|||||||0.774|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression speed experiment (instant, fast, slow).||||.774
71892393|NCT01381094|143306452|SUPERIORITY||||||=|0.2065|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.2065
71892394|NCT01381094|143306452|SUPERIORITY||||||=|0.1807|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.1807
71756785|NCT00929695|143017202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.95|TWO_SIDED|95.0|0.6|1.74|||Regression, Cox|||||1.74|0.6|0.95
71756786|NCT01352715|143017219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.|Cumulative probability difference|-3.4|||||TWO_SIDED|95.0|-8.4|1.5||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.||1.5|-8.4|
71837665|NCT03850678|143182268|SUPERIORITY||||||<|0.001|||||||ANOVA|||This analysis examined Q10 for those participants who completed the compression channel conditions (4, 8, 16).||||<.001
71837666|NCT03850678|143182268|SUPERIORITY|||||||0.167|||||||ANOVA|||This analysis compared Q10 for those participants who completed the unaided and aided conditions.||||.167
71671526|NCT00471081|142860545|SUPERIORITY||Percentage of subjects with hSBA titers|99.3|||||TWO_SIDED|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.||100|96.2|
71789048|NCT02663232|143075625|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.822||||0.653|TWO_SIDED|95.0|0.351|1.928|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.||1.928|0.351|0.653
71789049|NCT02663232|143075626|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.240
71789050|NCT02663232|143075627|SUPERIORITY_OR_OTHER_LEGACY|||||||0.719|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.719
71789051|NCT02663232|143075628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of primary tumor site (trunk \[referral category\] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.262
71789052|NCT02663232|143075629|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of LDH (elevated \[referral category\] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.313
71789053|NCT02663232|143075630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.291
71671527|NCT04537078|142860579|OTHER||Median Difference (Final Values)|1.5||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
71671528|NCT04537078|142860580|OTHER||Median Difference (Final Values)|9.48||||0.219|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.219
71756787|NCT04109547|143017286|SUPERIORITY||Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.3|-1.8|<0.0001
71756788|NCT04109547|143017286|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-1.2|-1.6|<0.0001
71756789|NCT04109547|143017286|SUPERIORITY||Treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM|||||-0.8|-1.2|<0.0001
71756790|NCT01656408|143017352|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|3.8||0.978|TWO_SIDED|90.0|-6.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||6.6|-6.4|0.978
71789054|NCT02663232|143075631|SUPERIORITY_OR_OTHER_LEGACY|||||||0.164|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample source (primary tumor \[referral category\] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.164
71837667|NCT03850678|143182269|SUPERIORITY|||||||0.741|||||||ANOVA|||Statistical analysis of number of compression channels (unaided, 4 channel, 16 channels)||||.741
71837668|NCT03850678|143182269|SUPERIORITY|||||||0.062||||||Due to Levene's Test for Equality of Variances, equal variances were not assumed.|t-test, 1 sided|||Spatial Release from Masking, unaided.||||.062
71837669|NCT03850678|143182270|SUPERIORITY|||||||0.805|||||||Regression, Linear|||Linear regression of score for the reading span (independent variable) to Q10 (dependent variable, 16 channel compression condition) for the participants who completed the compression channel experiment.||||.805
71837670|NCT04640298|143182275|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71837671|NCT04640298|143182276|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71837672|NCT04640298|143182277|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71837673|NCT00534469|143182303|OTHER|Two-sided test.||||||0.43||||||Log-rank test (Mantel-Haenszel test). This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Log Rank|||Null hypothesis: All four groups are drawn from the same distribution. Alternative hypothesis: At least one of the groups has measurably different survival from the others.||||0.43
71837674|NCT05717907|143182308|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.000
71789055|NCT02663232|143075632|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample type (paraffin-embedded blocks \[referral category\] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.505
71789056|NCT02663232|143075633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of method of fixation (buffered formalin \[referral category\] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.701
71789057|NCT02663232|143075634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.683|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Berslow thickness (≤1 mm \[referral category\] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.683
71789058|NCT02663232|143075635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Ulceration (no \[referral category\] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.615
71789059|NCT02663232|143075636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.949|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of presence of regression (Without regression \[referral category\] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.949
71789060|NCT02663232|143075637|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|TWO_SIDED||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Vascular invasion (Without vascular invasion \[referral category\] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.||||0.374
71837675|NCT04166773|143182313|SUPERIORITY||Odds Ratio (OR)|7.45|||<|0.001|TWO_SIDED|95.0|2.27|24.44|||Regression, Logistic||Odds ratio, Confidence Interval (CI), and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||24.44|2.27|<0.001
71837676|NCT04166773|143182313|SUPERIORITY||Odds Ratio (OR)|11.86|||<|0.001|TWO_SIDED|95.0|3.59|39.11|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||39.11|3.59|<0.001
71789061|NCT00732615|143075671|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|52.3|||<|0.001|TWO_SIDED|95.0|40.6|64.0||A fixed sequence test procedure was used to control the study level type I error. Order of test sequence started with the primary efficacy endpoint and proceeded to the 3 secondary efficacy endpoints, in the order defined in the protocol.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between NPSP558 and the placebo treatment groups.|The above two sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis is that the % of subjects meeting primary efficacy endpoint criteria are the same for both tmt arms. The sample size was determined based on the assumption that 40% and 10% of subjects for NPSP558 and pbo arms would meet the endpt criteria, respectively. Based on 2-tailed test, alpha of 0.05 and 2-to-1 randomization ratio, 84 (56 NPSP558, 28 pbo) subjects who completing the study would achieve 80% statistical power. Adjusted for dropouts, planned enrollment was 110 subjects.||64.0|40.6|<0.001
71789062|NCT00732615|143075672|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the primary endpoint reached statistical significance.|ANCOVA|ANCOVA analysis conducted using percentage change from baseline as dependent variable, treatment as factor, and baseline calcium dose as covariate.||The null hypothesis is that there is no difference between the percentage changes from baseline for the two treatment arms.||||<0.001
71837677|NCT04166773|143182313|SUPERIORITY||Odds Ratio (OR)|19.63|||<|0.001|TWO_SIDED|95.0|5.73|67.25|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||67.25|5.73|<0.001
71837678|NCT04166773|143182314|SUPERIORITY||Odds Ratio (OR)|3.01||||0.025|TWO_SIDED|95.0|1.15|7.9|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||7.90|1.15|0.025
71789063|NCT00732615|143075673|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.711|||<|0.001|TWO_SIDED|95.0|2.619|52.363||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the first secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the proportions of subjects (who achieved this secondary endpoint) from the two treatment arms.||52.363|2.619|<0.001
71837679|NCT04166773|143182314|SUPERIORITY||Odds Ratio (OR)|2.37||||0.074|TWO_SIDED|95.0|0.92|6.13|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors|||6.13|0.92|0.074
71837680|NCT04166773|143182314|SUPERIORITY||Odds Ratio (OR)|2.47||||0.063|TWO_SIDED|95.0|0.95|6.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||6.40|0.95|0.063
71837681|NCT04166773|143182315|SUPERIORITY||Odds Ratio (OR)|0.91||||0.893|TWO_SIDED|95.0|0.25|3.4|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||3.40|0.25|0.893
71837682|NCT04166773|143182315|SUPERIORITY||Odds Ratio (OR)|0.73||||0.647|TWO_SIDED|95.0|0.18|2.87|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||2.87|0.18|0.647
71837683|NCT04166773|143182315|SUPERIORITY||Odds Ratio (OR)|0.39||||0.246|TWO_SIDED|95.0|0.08|1.91|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||1.91|0.08|0.246
71671529|NCT04537078|142860581|OTHER||Median Difference (Final Values)|1.0||||0.269|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.269
71671530|NCT04537078|142860582|OTHER||Median Difference (Final Values)|0.0||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.072
71671531|NCT04537078|142860583|OTHER|||||||1|||||||Fisher Exact|||||||1
71671532|NCT04537078|142860584|OTHER|||||||0.72|||||||Chi-squared|||||||0.720
71671533|NCT04537078|142860585|OTHER||Median Difference (Final Values)|2.0||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.002
71671534|NCT04537078|142860586|OTHER||Median Difference (Final Values)|600.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71671535|NCT04537078|142860587|OTHER||Median Difference (Final Values)|2.0||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.001
71671536|NCT04537078|142860588|OTHER||Median Difference (Final Values)|33.33||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71671537|NCT04537078|142860589|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71671538|NCT04537078|142860590|OTHER||Median Difference (Final Values)|0.0||||0.851|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.851
71756791|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.9|STANDARD_ERROR_OF_MEAN|3.2||0.005|TWO_SIDED|90.0|-15.4|-4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.5|-15.4|0.005
71756792|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.1|STANDARD_ERROR_OF_MEAN|3.3||0|TWO_SIDED|90.0|-19.8|-8.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-8.4|-19.8|0.000
71756793|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|3.2||0.03|TWO_SIDED|90.0|-13.0|-1.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-1.9|-13.0|0.030
71789064|NCT00732615|143075674|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.879||||0.747|TWO_SIDED|95.0|0.402|1.922||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the second secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that the percentages of subjects with any reported clinical symptoms for the two treatment arms are the same.||1.922|0.402|0.747
71789065|NCT00748033|143075718|OTHER|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0650
71671539|NCT04537078|142860591|OTHER||Median Difference (Final Values)|25.0||||0.304|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.304
71671540|NCT04537078|142860592|OTHER||Median Difference (Final Values)|1.0||||0.486|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.486
71671541|NCT01568892|142860593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|||<|0.001|TWO_SIDED|95.0|-1.52|-0.8|||ANCOVA||The estimated value represents the adjusted mean difference between the two treatment arms.|||-0.80|-1.52|<0.001
71671542|NCT01697748|142860671|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.44|1.96||Variables with at least a borderline association with a treatment arm (P≤ .10) were included in a multiple logistic regression model to verify which is independently associated with the outcome of interest||No P values were reported for the association between dressing type and infection, only relative risk and 95% confidence intervals were reported.||With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate|1.96|0.44|
71671543|NCT01697748|142860671|SUPERIORITY|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|||||<|0.05|TWO_SIDED|95.0||||Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest|Mixed Models Analysis|In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.||||||<0.05
71671544|NCT01697748|142860672|SUPERIORITY||||||<|0.05|||||||see below|Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate|||In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate|||<.05
71756794|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|4.9||0.484|TWO_SIDED|90.0|-4.9|11.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||11.9|-4.9|0.484
71756795|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.0||0.169|TWO_SIDED|90.0|-9.3|0.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||0.9|-9.3|0.169
71756796|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|3.6||0.023|TWO_SIDED|90.0|-14.9|-2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-2.6|-14.9|0.023
71756797|NCT01656408|143017352|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|4.6||0.605|TWO_SIDED|90.0|-10.4|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||5.5|-10.4|0.605
71756798|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.9||0.635|TWO_SIDED|90.0|-4.9|8.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||8.7|-4.9|0.635
71756799|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.8||0.077|TWO_SIDED|90.0|-10.1|-0.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.4|-10.1|0.077
71756800|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|90.0|-15.0|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.7|-15.0|0.001
71789066|NCT00748033|143075719|OTHER|||||||0.2487|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.2487
71671545|NCT01697748|142860673|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate|||<.05
71789067|NCT00748033|143075720|OTHER|||||||0.7288|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.7288
71789068|NCT00748033|143075721|OTHER|||||||0.0045|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test, two-sided. Testing the hypothesis that the perception is same.||||0.0045
71789069|NCT00748033|143075722|OTHER|||||||0.4561|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at insertion.||||0.4561
71789070|NCT00748033|143075723|OTHER|||||||0.1797|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||Testing the hypothesis that 5s and 24 h are equal at withdrawal.||||0.1797
71789071|NCT00748033|143075724|OTHER|||||||0.5171|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test if the difference between 5s and 24h is equal to 0.||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.5171
71789072|NCT00748033|143075725|OTHER|||||||0.7105|||||||Wilcoxon (Mann-Whitney)|||The mean perception of the 5s and the 24h catheter is calculated for each patient. The patients are then divided in two groups depending on the order the patients received the two catheters and the hypotheses that the mean of the 5s and the 24h catheter is equal in the two groups are tested. If the test results in a significant p-value it can be concluded that a carry-over effect is present.||||0.7105
71789073|NCT00748033|143075726|OTHER|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||||||0.0003
71789074|NCT00748033|143075727|OTHER|||||||0.0346|||||||Wilcoxon (Mann-Whitney)|||||||0.0346
71789075|NCT00748033|143075728|OTHER|||||||0.0016|||||||Wilcoxon (Mann-Whitney)|||||||0.0016
71789076|NCT00459667|143075767|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|17.4||||||95.0|14.4|20.7||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||20.7|14.4|
71837684|NCT04166773|143182316|SUPERIORITY||Odds Ratio (OR)|6.94|||<|0.001|TWO_SIDED|95.0|2.41|20.0|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||20.00|2.41|<0.001
71789077|NCT00459667|143075767|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|15.8||||||95.0|13.1|18.9||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||18.9|13.1|
71789078|NCT00459667|143075767|SUPERIORITY_OR_OTHER||Number of patients w/ Flu-Like-Syndrome|31.1||||||95.0|24.4|38.4||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome||38.4|24.4|
71789079|NCT00459667|143075768|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|28.0|35.7||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||35.7|28.0|
71789080|NCT00459667|143075768|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|26.2||||||95.0|22.8|29.8||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||29.8|22.8|
71789081|NCT00459667|143075768|SUPERIORITY_OR_OTHER||number of patients w/ IS reactions.|31.7||||||95.0|24.9|39.0||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.||39.0|24.9|
71789082|NCT02671422|143075776|OTHER||1 year-survival rate|0.342|||||TWO_SIDED|95.0|0.0|0.894|||||Confidence interval is computed based on the LOGLOG method.|||0.894|0.000|
71789083|NCT04702997|143075787|SUPERIORITY||LS Mean difference (Net)|7.71|STANDARD_ERROR_OF_MEAN|1.268|<|0.0001|TWO_SIDED|95.0|5.18|10.24||KDIGO strata, treatment group, time (Week 1 to 12), and the interaction between treatment and time were used as fixed factors.|Mixed Models Analysis||Difference is bardoxolone methyl - placebo|||10.24|5.18|<0.0001
71789084|NCT00353262|143075949|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.79|1.02||||||Cycle 2, Day 1 versus Cycle 1, Day 1||1.02|0.79|
71789085|NCT00353262|143075949|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.76|0.99||||||Cycle 3, Day 1 versus Cycle 1, Day 1||0.99|0.76|
71789086|NCT00353262|143075949|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.85|1.1||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.10|0.85|
71789087|NCT00353262|143075950|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.01|1.08||||||Cycle 2, Day 1 versus Cycle 1, Day 2||1.08|1.01|
71789088|NCT00353262|143075950|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05||||||Cycle 3, Day 1 to Cycle 1, Day 2||1.05|0.98|
71789089|NCT00353262|143075950|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Cycle 3, Day 1 to Cycle 2, Day 1||1.00|0.94|
71789090|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.83|1.24||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.24|0.83|
71789091|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|90.0|0.94|1.42||||||Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1||1.42|0.94|
71789092|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.17|||||TWO_SIDED|90.0|0.96|1.44||||||Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1||1.44|0.96|
71789093|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.69|1.08||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.69|
71789094|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.86|1.34||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.34|0.86|
71789095|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.25|||||TWO_SIDED|90.0|1.0|1.55||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.55|1.00|
71789096|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.66|1.01||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||1.01|0.66|
71789097|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.79|||||TWO_SIDED|90.0|0.64|0.97||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.97|0.64|
71671546|NCT01697748|142860673|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate|||<.05
71892395|NCT01381094|143306452|SUPERIORITY||||||=|0.7869|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.7869
71671547|NCT01697748|142860675|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate|||<0.05
71671548|NCT01697748|142860676|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||||In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate|||<0.05
71671549|NCT01704495|142860685|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.56||||0.119|TWO_SIDED|90.0|0.98|2.49||2-sided p-value|Poisson regression|Correction for overdispersion made by Pearson chi-square|AZD5069 45 mg BID vs Placebo|||2.49|0.98|0.119
71671550|NCT01704495|142860685|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.53||||0.141|TWO_SIDED|90.0|0.95|2.46||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 15 mg BID vs Placebo|||2.46|0.95|0.141
71671551|NCT01704495|142860685|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.397|TWO_SIDED|90.0|0.79|2.11||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 5 mg BID vs Placebo|||2.11|0.79|0.397
71671552|NCT00997373|142860730|SUPERIORITY_OR_OTHER|||||||0.0373|TWO_SIDED||||||Fisher Exact|||||||0.0373
71789098|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.78|1.19||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.19|0.78|
71789099|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.04|0.91|
71789100|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.9|1.04||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||1.04|0.90|
71789101|NCT00353262|143075951|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.93|
71789102|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.61|0.9||||||5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1||0.90|0.61|
71671553|NCT01753310|142860772|SUPERIORITY_OR_OTHER||Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-12.17|-4.47|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-4.47|-12.17|<0.001
71671554|NCT01753310|142860773|SUPERIORITY_OR_OTHER||Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|1.65|=|0.001|TWO_SIDED|95.0|-8.67|-2.14|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).||-2.14|-8.67|=0.001
71789103|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.64|||||TWO_SIDED|90.0|0.53|0.79||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1||0.79|0.53|
71789104|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.71|1.06||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.06|0.71|
71789105|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.63|1.08||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1||1.08|0.63|
71789106|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03|||||TWO_SIDED|90.0|0.78|1.34||||||Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1||1.34|0.78|
71789107|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.65|1.1||||||Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1||1.10|0.65|
71789108|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.65|1.18||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1||1.18|0.65|
71789109|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.71|1.3||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1||1.30|0.71|
71789110|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1|||||TWO_SIDED|90.0|0.81|1.49||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1||1.49|0.81|
71789111|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.74|||||TWO_SIDED|90.0|0.56|0.98||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1||0.98|0.56|
71789112|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.58|||||TWO_SIDED|90.0|0.44|0.76||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1||0.76|0.44|
71789113|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.78|||||TWO_SIDED|90.0|0.59|1.03||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1||1.03|0.59|
71789114|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1||1.00|0.83|
71789115|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.76|0.91||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1||0.91|0.76|
71789116|NCT00353262|143075953|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.83|1.0||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1||1.00|0.83|
71789117|NCT00353262|143075955|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|1.09|1.33||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.33|1.09|
71789118|NCT00353262|143075955|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.34|||||TWO_SIDED|90.0|1.21|1.48||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.48|1.21|
71892396|NCT01381094|143306452|SUPERIORITY||||||=|0.4743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.4743
71892397|NCT01381094|143306452|SUPERIORITY||||||=|0.6407|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.6407
71892398|NCT01381094|143306453|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71837685|NCT04166773|143182316|SUPERIORITY||Odds Ratio (OR)|10.46|||<|0.001|TWO_SIDED|95.0|3.36|32.61|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||32.61|3.36|<0.001
71671555|NCT01753310|142860774|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.||||<0.001
71671556|NCT01753310|142860775|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||=0.033
71671557|NCT01753310|142860776|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||<0.001
71671558|NCT01753310|142860777|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.||||<0.001
71671559|NCT01753310|142860778|SUPERIORITY_OR_OTHER||||||=|0.174|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.174
71671560|NCT01753310|142860779|SUPERIORITY_OR_OTHER||||||=|0.583|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.||||=0.583
71837686|NCT04166773|143182316|SUPERIORITY||Odds Ratio (OR)|12.85|||<|0.001|TWO_SIDED|95.0|3.87|42.65|||Regression, Logistic||Odds ratio, CI, and p-value for endpoint measures are from logistic regression model with baseline diabetes status, region, treatment as factors.|||42.65|3.87|<0.001
71837687|NCT04166773|143182317|SUPERIORITY||LS Mean difference (Final Values)|-8.81|STANDARD_ERROR_OF_MEAN|1.632|<|0.001|TWO_SIDED|95.0|-12.04|-5.58|||Mixed Models Analysis|||||-5.58|-12.04|<0.001
71837688|NCT04166773|143182317|SUPERIORITY||LS Mean difference (Final Values)|-8.83|STANDARD_ERROR_OF_MEAN|1.566|<|0.001|TWO_SIDED|95.0|-11.93|-5.73|||Mixed Models Analysis|||||-5.73|-11.93|<0.001
71837689|NCT04166773|143182317|SUPERIORITY||LS Mean difference (Final Values)|-10.02|STANDARD_ERROR_OF_MEAN|1.591|<|0.001|TWO_SIDED|95.0|-13.17|-6.87|||Mixed Models Analysis|||||-6.87|-13.17|<0.001
71671561|NCT02166333|142860790|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.54|TWO_SIDED|95.0|0.76|1.15||The P value is nominal and two-sided.|Log Rank||The Experience on Best Dose versus 200 IU/day hazard ratio and its 95% confidence interval were derived from a Cox regression model with dose group as the single model variable.|The Experience on Best Dose group includes all participants assigned or switched to best dose (1000 IU/day) and excludes 41 participants randomized to 2000 or 4000 IU/day who were never issued a bottle of best dose. For those randomized to 2000 or 4000 IU/day, at-risk time and events are measured from the date of their switch to best dose. 150 Experience on Best Dose participants (median follow-up, 10.2 mos) and 125 200 IU/day participants (median follow-up, 20.3 mos) were censored.||1.15|0.76|0.54
71837690|NCT04166773|143182318|SUPERIORITY||LS Mean difference (Final Values)|-10.42|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-14.32|-6.52|||Mixed Models Analysis|||||-6.52|-14.32|<0.001
71671562|NCT02166333|142860790|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.86|1.25|||||The comparison of the Pooled Higher Doses group versus the 200 IU/d group is a sensitivity analysis.|||1.25|0.86|
71671563|NCT02166333|142860791|SUPERIORITY|The overall P tests for difference between groups in differential change from baseline over time and is from a 3 degree of freedom test of the combined 3 treatment-by-time interaction terms from the longitudinal mixed effects model.||||||0.15||||||The P value is nominal and not adjusted for multiple comparisons.|Regression, Linear|3 degree of freedom interaction test||The two groups were assessed for differential change over time in change from baseline using a longitudinal mixed effects regression model with gait speed as the outcome and fixed effects including a single treatment term, 3 time point terms and 3 treatment-by-time interaction terms and a random intercept for participant.||||0.15
71671564|NCT00359424|142860817|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.5||||0.7031|TWO_SIDED|95.0|-6.1|9.1||The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).||9.1|-6.1|.7031
71756801|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.5||0.556|TWO_SIDED|90.0|-8.0|3.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.9|-8.0|0.556
71756802|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.3||0.527|TWO_SIDED|90.0|-5.5|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||2.5|-5.5|0.527
71756803|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.8||0.234|TWO_SIDED|90.0|-8.1|1.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||1.4|-8.1|0.234
71756804|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|90.0|-12.7|-4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-4.1|-12.7|0.002
71756805|NCT01656408|143017353|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|3.1||0.726|TWO_SIDED|90.0|-4.2|6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.5|-4.2|0.726
71756806|NCT01656408|143017354|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.5||0.855|TWO_SIDED|90.0|-9.0|7.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||7.3|-9.0|0.855
71756807|NCT01656408|143017354|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|8.1||0.658|TWO_SIDED|90.0|-10.8|18.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||18.1|-10.8|0.658
71837691|NCT04166773|143182318|SUPERIORITY||LS Mean difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-17.05|-9.32|||Mixed Models Analysis|||||-9.32|-17.05|<0.001
71837692|NCT04166773|143182318|SUPERIORITY||LS Mean difference (Final Values)|-16.84|STANDARD_ERROR_OF_MEAN|1.957|<|0.001|TWO_SIDED|95.0|-20.71|-12.98|||Mixed Models Analysis|||||-12.98|-20.71|<0.001
71837693|NCT04717492|143182368|OTHER||Cox Proportional Hazard|1.01||||0.962|TWO_SIDED|95.0|0.66|1.54||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to death, or first hospitalization or revascularization event was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.54|0.66|0.962
71837694|NCT04717492|143182370|OTHER||Cox Proportional Hazard|1.11||||0.694|TWO_SIDED|95.0|0.65|1.92||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to CVD-related death or hospitalization/revascularization was analyzed using cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.92|0.65|0.694
71837695|NCT04717492|143182372|OTHER||Cox Proportional Hazard|0.75||||0.476|TWO_SIDED|95.0|0.34|1.66||No adjustments for multiplicity were performed.|Regression, Cox|Cox proportional hazard model with inverse probability of treatment weighting as described in primary manuscript.||Time to respiratory/COPD-related death or hospitalization was analyzed using Cox proportional hazards models with inverse probability of treatment weighting (IPTW) to reduce confounding. Missing data were imputed using multivariate imputation by chained equations with predictive mean matching.||1.66|0.34|0.476
71671565|NCT00359424|142860818|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.5241|TWO_SIDED|99.0|-10.3|6.2||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).||6.2|-10.3|.5241
71837696|NCT04072380|143182386|SUPERIORITY|||||||0.024||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.024
71837697|NCT04072380|143182387|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.009
71837698|NCT04072380|143182388|SUPERIORITY|||||||0.734||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Mixed model for repeated measures (MMRM)||||||0.734
71837699|NCT04072380|143182389|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71837700|NCT04072380|143182390|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71837701|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.0|-1.0|
71837702|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup A if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.8|||||TWO_SIDED|95.0|-0.6|3.7||||||For serogroup A, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.7|-0.6|
71837703|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.3|1.9||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||1.9|-2.3|
71837704|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup C if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-0.8|||||TWO_SIDED|95.0|-3.3|2.5||||||For serogroup C, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||2.5|-3.3|
71837705|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-6.3|0.8||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||0.8|-6.3|
71892399|NCT01381094|143306453|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
71892400|NCT01381094|143306453|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71756808|NCT01656408|143017354|SUPERIORITY_OR_OTHER||LS Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|7.1||0.392|TWO_SIDED|90.0|-6.3|18.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||18.9|-6.3|0.392
71756809|NCT01656408|143017355|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|2.5||0.563|TWO_SIDED|90.0|-6.0|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-6.0|0.563
71756810|NCT01656408|143017355|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.9||0.381|TWO_SIDED|90.0|-0.8|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||2.5|-0.8|0.381
71756811|NCT01656408|143017355|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.0||0.387|TWO_SIDED|90.0|-1.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||5.2|-1.7|0.387
71756812|NCT01656408|143017356|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|4.7||0.357|TWO_SIDED|90.0|-3.9|12.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||12.8|-3.9|0.357
71756813|NCT01656408|143017356|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4|STANDARD_ERROR_OF_MEAN|4.8||0.15|TWO_SIDED|90.0|-1.2|15.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||15.9|-1.2|0.150
71756814|NCT01656408|143017356|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|5.2||0.578|TWO_SIDED|90.0|-6.3|12.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||12.3|-6.3|0.578
71756815|NCT01656408|143017357|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|3.0||0.942|TWO_SIDED|90.0|-5.1|5.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||5.5|-5.1|0.942
71756816|NCT01656408|143017357|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|3.7||0.627|TWO_SIDED|90.0|-4.8|8.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||8.5|-4.8|0.627
71756817|NCT01656408|143017357|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|1.9||0.046|TWO_SIDED|90.0|0.9|7.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.6|0.9|0.046
71756818|NCT01656408|143017358|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.8|STANDARD_ERROR_OF_MEAN|3.8||0.025|TWO_SIDED|90.0|-18.0|-3.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.6|-18.0|0.025
71756819|NCT01656408|143017358|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.6||0.055|TWO_SIDED|90.0|-11.0|-1.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-1.1|-11.0|0.055
71756820|NCT01656408|143017359|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.6||0.999|TWO_SIDED|90.0|-4.4|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.4|-4.4|0.999
71756821|NCT01656408|143017359|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.2||0.934|TWO_SIDED|90.0|-5.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||5.2|-5.7|0.934
71756822|NCT01656408|143017359|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|3.4||0.547|TWO_SIDED|90.0|-3.7|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.9|-3.7|0.547
71756823|NCT01656408|143017359|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|2.9||0.906|TWO_SIDED|90.0|-5.2|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.5|-5.2|0.906
71756824|NCT01656408|143017359|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.1||0.682|TWO_SIDED|90.0|-4.0|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||6.6|-4.0|0.682
71756825|NCT01656408|143017360|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|2.8||0.099|TWO_SIDED|90.0|-11.1|0.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||0.0|-11.1|0.099
71756826|NCT01656408|143017360|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.1||0.034|TWO_SIDED|90.0|-10.1|-1.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.7|-10.1|0.034
71756827|NCT01656408|143017361|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.0||0.281|TWO_SIDED|90.0|-6.5|1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||1.6|-6.5|0.281
71756828|NCT01656408|143017361|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.333|TWO_SIDED|90.0|-1.2|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||4.0|-1.2|0.333
71756829|NCT01656408|143017362|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.4||0.279|TWO_SIDED|90.0|-9.7|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.1|-9.7|0.279
71756830|NCT01656408|143017362|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.4||0.817|TWO_SIDED|90.0|-6.9|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||5.2|-6.9|0.817
71756831|NCT01656408|143017363|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|2.4||0.756|TWO_SIDED|90.0|-3.2|4.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.7|-3.2|0.756
71756832|NCT01656408|143017363|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|2.8||0.158|TWO_SIDED|90.0|-0.7|8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.6|-0.7|0.158
71756833|NCT01656408|143017363|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.8||0.404|TWO_SIDED|90.0|-2.4|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-2.4|0.404
71756834|NCT01656408|143017363|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.4||0.214|TWO_SIDED|90.0|-1.0|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||7.1|-1.0|0.214
71756835|NCT01656408|143017363|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|2.9||0.086|TWO_SIDED|90.0|0.2|10.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||10.0|0.2|0.086
71756836|NCT01656408|143017364|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|90.0|-16.8|-5.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-5.9|-16.8|0.003
71756837|NCT01656408|143017364|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|3.5||0.105|TWO_SIDED|90.0|-12.3|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.1|-12.3|0.105
71837706|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup W if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|0.3|||||TWO_SIDED|95.0|-1.8|3.5||||||For serogroup W, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||3.5|-1.8|
71837707|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|-3.0|||||TWO_SIDED|95.0|-5.4|-0.4||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||-0.4|-5.4|
71837708|NCT05093829|143182433|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup Y if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. Difference in proportions and confidence intervals are reported as percentages (number of infants per 100).|Difference in proportions|1.4|||||TWO_SIDED|95.0|-0.6|4.8||||||For serogroup Y, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||4.8|-0.6|
71837709|NCT05093829|143182434|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|2.3|||||TWO_SIDED|95.0|0.3|4.7||||||For the 9-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup W is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.7|0.3|
71837710|NCT05093829|143182434|NON_INFERIORITY|NmCV-5 will be deemed non-inferior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval (CI) for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes -0.10 (-10%). The CI is estimated using bootstrap resampling stratified by vaccine arm, and the 95% CI is estimated as the interval between the 2.5th and 97.5th percentiles of the bootstrap empirical distribution. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|1.9|||||TWO_SIDED|95.0|0.004|4.4||||||For the 15-months study age group, the proportion of infants with a seroprotective response to MenACWY-TT in serogroup Y is subtracted from the proportion of infants with a seroprotective response to NmCV-5 in serogroup X to determine the difference in proportions.||4.4|0.004|
71837711|NCT05093829|143182438|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|82.5|||||TWO_SIDED|95.0|76.4|87.2||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||87.2|76.4|
71837712|NCT05093829|143182438|SUPERIORITY|NmCV-5 will be deemed superior to MenACWY-TT for serogroup X if the lower limit of the 95% confidence interval for the difference in proportion (NmCV-5 minus MenACWY-TT) excludes 0.30 (30%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|68.4|||||TWO_SIDED|95.0|61.3|74.7||||||For serogroup X, the proportion of infants with a seroprotective response to MenACWY-TT is subtracted from the proportion of infants with a seroprotective response to NmCV-5 to determine the difference in proportions.||74.7|61.3|
71892401|NCT01381094|143306453|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71671566|NCT00359424|142860819|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.4||||0.8275|TWO_SIDED|99.0|-4.6|5.5||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (\<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).||5.5|-4.6|.8275
71671567|NCT03805412|142860870|SUPERIORITY|||||||0.694|||||||t-test, 2 sided|||||||0.694
71671568|NCT05514873|142860877|NON_INFERIORITY|Non-inferiority of Week 12 MG-ADL over Baseline was shown if the upper limit of the 2-sided 95% confidence interval (CI) is less than 2.|||||<|0.001|||||||Mixed Model for Repeated Measures (MMRM)|||||||<0.001
71671569|NCT07091916|142860898|OTHER|This objective was for the purpose of gathering data pertaining to device safety over the first 2 weeks post-implant. There were no pre-specified performance criteria or hypotheses for this objective.|Proportion|92.9|||||TWO_SIDED||||||descriptive statistics|||The first primary objective is to characterize the freedom from major complications related to the EV ICD System and/or procedure at 2 weeks post-implant. The endpoint is defined as a subject's first occurrence of a major complication related to the EV ICD System and/or procedure, as determined by an independent Clinical Events Committee (CEC), that occurs on or prior to 2 weeks (14 days) post-implant.||||
71671570|NCT07091916|142860899|OTHER|There were no hypotheses for this objective.|Proportion|100.0|||||||||||descriptive statistics|||The primary efficacy objective was to characterize the defibrillation efficacy at implant of the EV ICD System.||||
71671571|NCT03158038|142861025|SUPERIORITY||Rate difference|0.0|||||TWO_SIDED|95.0|-6.7|1.9||||||||1.9|-6.7|
71671572|NCT03158038|142861026|SUPERIORITY||Rate difference|1.3|||||TWO_SIDED|95.0|-12.8|13.2||||||Statistical analysis up to Day 8||13.2|-12.8|
71671573|NCT03158038|142861026|SUPERIORITY||Rate difference|0.4|||||TWO_SIDED|95.0|-14.1|13.2||||||Statistical analysis up to Day 15||13.2|-14.1|
71756838|NCT01656408|143017365|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|3.6||0.691|TWO_SIDED|90.0|-7.5|4.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.6|-7.5|0.691
71756839|NCT01656408|143017365|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.9||0.57|TWO_SIDED|90.0|-4.3|8.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 8||8.8|-4.3|0.570
71756840|NCT01656408|143017365|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|3.4||0.666|TWO_SIDED|90.0|-4.2|7.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||7.1|-4.2|0.666
71756841|NCT01656408|143017365|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|4.7||0.534|TWO_SIDED|90.0|-10.9|4.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 22||4.9|-10.9|0.534
71756842|NCT01656408|143017365|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|4.0||0.528|TWO_SIDED|90.0|-4.1|9.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||9.2|-4.1|0.528
71756843|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.0||0.848|TWO_SIDED|90.0|-3.8|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.0|-3.8|0.848
71789119|NCT00353262|143075955|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.01|1.23||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.23|1.01|
71756844|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-8.0|-4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-4.0|-8.0|<0.0001
71756845|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.5||0.025|TWO_SIDED|90.0|-14.4|-2.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.4|-14.4|0.025
71789120|NCT00353262|143075957|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.96|
71789121|NCT00353262|143075957|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.95|
71789122|NCT00353262|143075957|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.05|0.93|
71789123|NCT00353262|143075957|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2||1.09|0.94|
71789124|NCT00353262|143075957|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2||1.08|0.92|
71789125|NCT00353262|143075957|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.07||||||Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1||1.07|0.91|
71756846|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.8||0.044|TWO_SIDED|90.0|-7.0|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.8|-7.0|0.044
71756847|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.0||0.139|TWO_SIDED|90.0|-0.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||6.6|-0.4|0.139
71756848|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5||0.088|TWO_SIDED|90.0|-8.9|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-0.2|-8.9|0.088
71756849|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|2.2||0.023|TWO_SIDED|90.0|-9.3|-1.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-1.6|-9.3|0.023
71756850|NCT01656408|143017390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.878|TWO_SIDED|90.0|-4.5|3.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||3.8|-4.5|0.878
71756851|NCT01656408|143017391|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|3.2||0.512|TWO_SIDED|90.0|-3.4|7.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.7|-3.4|0.512
71789126|NCT02927080|143075990|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the TA muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|9.54|STANDARD_ERROR_OF_MEAN|3.876||0.0138|TWO_SIDED|90.0|3.17|15.92|||ANCOVA|||D190 Percent change from baseline in TMV||15.92|3.17|0.0138
71789127|NCT02927080|143075990|SUPERIORITY|Percent Change in Total Muscle Volume (TMV) of the BB muscle in patients with FSHD administered ACE-083 when compared to placebo During Part 2 (randomized, controlled portion)|Mean Difference (Net)|16.39|STANDARD_ERROR_OF_MEAN|4.032|<|0.0001|TWO_SIDED|90.0|9.75|23.02|||ANCOVA|||D190 Percent change from baseline in TMV||23.02|9.75|<0.0001
71789128|NCT02927080|143075992|SUPERIORITY||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|1.299||0.0359|TWO_SIDED|90.0|-4.86|-0.59|||ANCOVA|||D190 Absolute change from baseline in FF for the TA group administered ACE-083 when compared to Placebo in part 2||-0.59|-4.86|0.0359
71789129|NCT02927080|143075992|SUPERIORITY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|1.359||0.3582|TWO_SIDED|90.0|-3.49|0.99|||ANCOVA|||D190 Absolute change from baseline in FF for the BB group administered ACE-083 when compared to Placebo in part 2||0.99|-3.49|0.3582
71789130|NCT02927080|143075993|SUPERIORITY||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|4.068||0.1945|TWO_SIDED|90.0|-11.97|1.41|||ANCOVA|||D190 Percent change from baseline in 6 Minute Walk Test (MWT) distance from baseline||1.41|-11.97|0.1945
71789131|NCT02927080|143075993|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|4.968||0.3451|TWO_SIDED|90.0|-3.48|12.86|||ANCOVA|||D190 Percent change from baseline in time to complete a 10 meter walk/run||12.86|-3.48|0.3451
71756852|NCT01656408|143017391|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|3.0||0.429|TWO_SIDED|90.0|-7.5|2.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.7|-7.5|0.429
71756853|NCT01656408|143017391|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|2.9||0.166|TWO_SIDED|90.0|-9.3|0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.8|-9.3|0.166
71756854|NCT01656408|143017391|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|3.8||0.591|TWO_SIDED|90.0|-8.6|4.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.5|-8.6|0.591
71756855|NCT01656408|143017392|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|4.7||0.248|TWO_SIDED|90.0|-2.5|13.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.5|-2.5|0.248
71756856|NCT01656408|143017392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|2.9||0.836|TWO_SIDED|90.0|-5.6|4.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.4|-5.6|0.836
71756857|NCT01656408|143017392|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2||0.109|TWO_SIDED|90.0|-10.7|0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.1|-10.7|0.109
71756858|NCT01656408|143017392|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|3.7||0.785|TWO_SIDED|90.0|-5.4|7.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.5|-5.4|0.785
71756859|NCT01656408|143017393|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|3.2||0.365|TWO_SIDED|90.0|-2.5|8.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.3|-2.5|0.365
71756860|NCT01656408|143017393|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.9||0.424|TWO_SIDED|90.0|-7.4|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.6|-7.4|0.424
71789132|NCT02927080|143075993|SUPERIORITY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|6.03||0.9402|TWO_SIDED|90.0|-9.47|10.37|||ANCOVA|||D190 Percent change from baseline in time to complete 4-stair climb (ascend)||10.37|-9.47|0.9402
71789133|NCT02927080|143075994|SUPERIORITY||Mean Difference (Final Values)|36.12|STANDARD_ERROR_OF_MEAN|14.18||0.0183|TWO_SIDED|90.0|11.78|60.46|||ANCOVA|||||60.46|11.78|0.0183
71892402|NCT01381094|143306453|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71671574|NCT02612623|142861079|OTHER||LSM Difference|-0.56|||||TWO_SIDED|95.0|-2.08|0.96|||||Gefapixant minus Placebo|Least squares mean (LSM) difference: Mixed effect repeated measures model (MMRM) uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.96|-2.08|
71756861|NCT01656408|143017393|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|3.2||0.025|TWO_SIDED|90.0|-13.3|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.2|-13.3|0.025
71756862|NCT01656408|143017393|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|3.1||0.475|TWO_SIDED|90.0|-7.5|3.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.0|-7.5|0.475
71756863|NCT01656408|143017394|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.4||0.715|TWO_SIDED|90.0|-7.4|4.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||4.8|-7.4|0.715
71756864|NCT01656408|143017394|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|4.3||0.338|TWO_SIDED|90.0|-11.9|3.4|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||3.4|-11.9|0.338
71756865|NCT01656408|143017394|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.4||0.281|TWO_SIDED|90.0|-10.0|2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||2.3|-10.0|0.281
71756866|NCT01656408|143017395|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.8||0.317|TWO_SIDED|90.0|-2.1|7.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.9|-2.1|0.317
71756867|NCT01656408|143017396|SUPERIORITY_OR_OTHER||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|3.6||0.09|TWO_SIDED|90.0|0.2|13.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||13.2|0.2|0.090
71756868|NCT01656408|143017397|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.0||0.128|TWO_SIDED|90.0|-0.3|6.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.8|-0.3|0.128
71756869|NCT01656408|143017398|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|3.1||0.477|TWO_SIDED|90.0|-7.9|3.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||3.3|-7.9|0.477
71756870|NCT01656408|143017398|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.0||0.09|TWO_SIDED|90.0|-11.0|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 6||-0.2|-11.0|0.090
71756871|NCT01656408|143017398|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.0||0.028|TWO_SIDED|90.0|-13.0|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 15||-2.2|-13.0|0.028
71756872|NCT01656408|143017399|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.5||0.877|TWO_SIDED|90.0|-4.9|4.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.1|-4.9|0.877
71756873|NCT01656408|143017400|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|4.6||0.827|TWO_SIDED|90.0|-9.3|7.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.2|-9.3|0.827
71756874|NCT01656408|143017401|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|3.5||0.161|TWO_SIDED|90.0|-11.4|1.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.0|-11.4|0.161
71756875|NCT01656408|143017402|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.5|STANDARD_ERROR_OF_MEAN|4.4||0.046|TWO_SIDED|90.0|-18.8|-2.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-2.3|-18.8|0.046
71756876|NCT01656408|143017402|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.3||0.001|TWO_SIDED|90.0|-17.2|-8.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-8.6|-17.2|0.001
71789134|NCT02927080|143075995|SUPERIORITY||Mean Difference (Final Values)|2.89|STANDARD_ERROR_OF_MEAN|1.7||0.0895|TWO_SIDED|90.0|0.09|5.69|||ANCOVA|||||5.69|0.09|0.0895
71892403|NCT01381094|143306454|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
71756877|NCT01656408|143017403|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.6||0.91|TWO_SIDED|90.0|-4.6|5.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.2|-4.6|0.910
71756878|NCT01656408|143017404|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|3.6||0.906|TWO_SIDED|90.0|-6.6|5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.7|-6.6|0.906
71671575|NCT02612623|142861079|OTHER||LSM Difference|-0.71|||||TWO_SIDED|95.0|-2.34|0.92|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.92|-2.34|
71756879|NCT01656408|143017405|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|2.4||0.87|TWO_SIDED|90.0|-4.4|3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.7|-4.4|0.870
71756880|NCT01656408|143017406|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|90.0|-5.0|-3.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-3.7|-5.0|<0.0001
71756881|NCT01656408|143017406|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.2|STANDARD_ERROR_OF_MEAN|1.2||0.001|TWO_SIDED|90.0|-10.7|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 10||-5.7|-10.7|0.001
71756882|NCT01656408|143017407|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.038|TWO_SIDED|90.0|-4.9|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.8|-4.9|0.038
71756883|NCT01656408|143017408|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.238|TWO_SIDED|90.0|-6.0|1.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.2|-6.0|0.238
71789135|NCT02927080|143075996|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|3.459||0.5661|TWO_SIDED|90.0|-7.67|3.7|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for TA group part 2; compared to Placebo||3.70|-7.67|0.5661
71789136|NCT02927080|143075996|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.618||0.976|TWO_SIDED|90.0|-6.06|5.84|||ANCOVA|||Change from baseline in FSHD-HI, patient-reported outcome (PRO) measures Part 2 (Randomized, Controlled Portion)- Total Score for BB group part 2; compared to Placebo||5.84|-6.06|0.9760
71789137|NCT01199289|143076005|SUPERIORITY||LS Mean Difference|-0.068||||0.5838|TWO_SIDED|95.0|-0.311|0.175|||ANCOVA|||||0.175|-0.311|0.5838
71789138|NCT01199289|143076005|SUPERIORITY||LS Mean Difference|-0.075||||0.5391|TWO_SIDED|95.0|-0.316|0.166|||ANCOVA|||||0.166|-0.316|0.5391
71789139|NCT01199289|143076005|SUPERIORITY||LS Mean Difference|-0.113||||0.3583|TWO_SIDED|95.0|-0.355|0.129|||ANCOVA|||||0.129|-0.355|0.3583
71671576|NCT02612623|142861079|OTHER||LSM Difference|-1.35|||||TWO_SIDED|95.0|-2.99|0.3|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||0.30|-2.99|
71756884|NCT01656408|143017409|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.048|TWO_SIDED|90.0|-4.7|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.6|-4.7|0.048
71756885|NCT01656408|143017410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.83|TWO_SIDED|90.0|-3.2|2.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||2.5|-3.2|0.830
71756886|NCT01656408|143017410|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|2.9||0.063|TWO_SIDED|90.0|-10.8|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||-0.7|-10.8|0.063
71756887|NCT01656408|143017411|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|3.7||0.892|TWO_SIDED|90.0|-7.1|6.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.1|-7.1|0.892
71756888|NCT01656408|143017412|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|3.1||0.571|TWO_SIDED|90.0|-3.4|6.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.9|-3.4|0.571
71756889|NCT01656408|143017413|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.8||0.816|TWO_SIDED|90.0|-5.4|4.0|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.0|-5.4|0.816
71756890|NCT01656408|143017414|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|2.2||0.061|TWO_SIDED|90.0|-8.4|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 1||-0.6|-8.4|0.061
71756891|NCT01656408|143017414|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|2.6||0.161|TWO_SIDED|90.0|-8.3|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|Day 28||0.7|-8.3|0.161
71756892|NCT01656408|143017415|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.0||0.786|TWO_SIDED|90.0|-4.0|2.9|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.9|-4.0|0.786
71756893|NCT01656408|143017416|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|3.3||0.263|TWO_SIDED|90.0|-9.3|1.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.8|-9.3|0.263
71756894|NCT01656408|143017417|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.0||0.565|TWO_SIDED|90.0|-4.4|2.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.1|-4.4|0.565
71756895|NCT05465317|143017418|OTHER||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.65|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.65|<0.001
71789140|NCT01199289|143076006|SUPERIORITY||LS Mean Difference|-0.047||||0.4076|TWO_SIDED|95.0|-0.157|0.064|||ANCOVA|||Pre-Bronchodilator||0.064|-0.157|0.4076
71789141|NCT01199289|143076006|SUPERIORITY||LS Mean Difference|-0.022||||0.6915|TWO_SIDED|95.0|-0.13|0.086|||ANCOVA|||Pre-Bronchodilator||0.086|-0.130|0.6915
71789142|NCT01199289|143076006|SUPERIORITY||LS Mean Difference|-0.019||||0.7271|TWO_SIDED|95.0|-0.126|0.088|||ANCOVA|||Pre-Bronchodilator||0.088|-0.126|0.7271
71789143|NCT01199289|143076006|SUPERIORITY||LS Mean Difference|0.005||||0.921|TWO_SIDED|95.0|-0.086|0.095|||ANCOVA|||Post-Bronchodilator||0.095|-0.086|0.9210
71789144|NCT01199289|143076006|SUPERIORITY||LS Mean Difference|0.07||||0.1139|TWO_SIDED|95.0|-0.017|0.157|||ANCOVA|||Post-Bronchodilator||0.157|-0.017|0.1139
71789145|NCT01199289|143076006|SUPERIORITY||LS Mean Difference|0.021||||0.6426|TWO_SIDED|95.0|-0.066|0.107|||ANCOVA|||Post-Bronchodilator||0.107|-0.066|0.6426
71671577|NCT02612623|142861079|OTHER||Percentage Change|-42.6|||||TWO_SIDED|95.0|-87.5|162.3|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||162.3|-87.5|
71671578|NCT02612623|142861079|OTHER||Percentage Change|-50.8|||||TWO_SIDED|95.0|-90.3|151.1|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||151.1|-90.3|
71789146|NCT01199289|143076007|SUPERIORITY||LS Mean Difference|-16.847||||0.0262|TWO_SIDED|95.0|-31.686|-2.009|||ANCOVA|||AM||-2.009|-31.686|0.0262
71789147|NCT01199289|143076007|SUPERIORITY||LS Mean Difference|-6.723||||0.3627|TWO_SIDED|95.0|-21.239|7.793|||ANCOVA|||AM||7.793|-21.239|0.3627
71789148|NCT01199289|143076007|SUPERIORITY||LS Mean Difference|-5.488||||0.4507|TWO_SIDED|95.0|-19.791|8.814|||ANCOVA|||AM||8.814|-19.791|0.4507
71789149|NCT01199289|143076007|SUPERIORITY||LS Mean Difference|-10.426||||0.1228|TWO_SIDED|95.0|-23.686|2.834|||ANCOVA|||PM||2.834|-23.686|0.1228
71789150|NCT01199289|143076007|SUPERIORITY||LS Mean Difference|-6.738||||0.3092|TWO_SIDED|95.0|-19.758|6.281|||ANCOVA|||PM||6.281|-19.758|0.3092
71789151|NCT01199289|143076007|SUPERIORITY||LS Mean Difference|-8.043||||0.2167|TWO_SIDED|95.0|-20.831|4.744|||ANCOVA|||PM||4.744|-20.831|0.2167
71789152|NCT01199289|143076008|SUPERIORITY||LS Mean Difference|0.331||||0.5157|TWO_SIDED|95.0|-0.67|1.332|||ANCOVA|||||1.332|-0.670|0.5157
71789153|NCT01199289|143076008|SUPERIORITY||LS Mean Difference|-0.234||||0.6434|TWO_SIDED|95.0|-1.229|0.76|||ANCOVA|||||0.760|-1.229|0.6434
71789154|NCT01199289|143076008|SUPERIORITY||LS Mean Difference|-0.199||||0.6954|TWO_SIDED|95.0|-1.196|0.799|||ANCOVA|||||0.799|-1.196|0.6954
71789155|NCT01199289|143076009|SUPERIORITY||LS Mean Difference|-0.283||||0.5577|TWO_SIDED|95.0|-1.231|0.665|||ANCOVA|||||0.665|-1.231|0.5577
71837713|NCT05093829|143182439|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.0||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.0|-1.0|
71837714|NCT05093829|143182439|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to measles if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to measles vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to measles vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
71837715|NCT05093829|143182440|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.5|2.6||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.6|-10.5|
71837716|NCT05093829|143182440|NON_INFERIORITY|The NmCV-5 co-administered MR vaccine will be deemed non-inferior to the MenACWY-TT co-administered MR vaccine in eliciting seropositive response to rubella if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.0|2.1||||||For this comparison, the proportion of infants with a seropositive response to rubella vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seropositive response to rubella vaccine in the NmCV-5 arm to determine the difference in proportions.||2.1|-1.0|
71789156|NCT01199289|143076009|SUPERIORITY||LS Mean Difference|0.038||||0.9366|TWO_SIDED|95.0|-0.904|0.98|||ANCOVA|||||0.980|-0.904|0.9366
71789157|NCT01199289|143076009|SUPERIORITY||LS Mean Difference|0.138||||0.7745|TWO_SIDED|95.0|-0.808|1.084|||ANCOVA|||||1.084|-0.808|0.7745
71789158|NCT01199289|143076010|SUPERIORITY||LS Mean Difference|0.026||||0.8524|TWO_SIDED|95.0|-0.251|0.303|||ANCOVA|||||0.303|-0.251|0.8524
71789159|NCT01199289|143076010|SUPERIORITY||LS Mean Difference|-0.033||||0.8139|TWO_SIDED|95.0|-0.305|0.24|||ANCOVA|||||0.240|-0.305|0.8139
71789160|NCT01199289|143076010|SUPERIORITY||LS Mean Difference|-0.002||||0.9881|TWO_SIDED|95.0|-0.281|0.276|||ANCOVA|||||0.276|-0.281|0.9881
71789161|NCT01199289|143076011|SUPERIORITY|With use of SABA|LS Mean Difference|-0.062||||0.1213|TWO_SIDED|95.0|-0.141|0.017|||ANCOVA|||||0.017|-0.141|0.1213
71789162|NCT01199289|143076011|SUPERIORITY|With use of SABA|LS Mean Difference|-0.017||||0.6643|TWO_SIDED|95.0|-0.095|0.061|||ANCOVA|||||0.061|-0.095|0.6643
71789163|NCT01199289|143076011|SUPERIORITY||LS Mean Difference|-0.042||||0.2879|TWO_SIDED|95.0|-0.121|0.036|||ANCOVA|With use of SABA||||0.036|-0.121|0.2879
71789164|NCT01199289|143076011|SUPERIORITY|Without use of SABA|LS Mean Difference|-0.074||||0.0546|TWO_SIDED|95.0|-0.15|0.001|||ANCOVA|||||0.001|-0.150|0.0546
71789165|NCT01199289|143076011|SUPERIORITY||LS Mean Difference|-0.004||||0.9078|TWO_SIDED|95.0|-0.08|0.071|||ANCOVA|||Without use of SABA||0.071|-0.080|0.9078
71789166|NCT01199289|143076011|SUPERIORITY||LS Mean Difference|-0.035||||0.3616|TWO_SIDED|95.0|-0.111|0.04|||ANCOVA|||Without use of SABA||0.040|-0.111|0.3616
71837717|NCT05093829|143182441|NON_INFERIORITY|The NmCV-5 co-administered yellow fever vaccine will be deemed non-inferior to the MenACWY-TT co-administered yellow fever vaccine in eliciting seroprotective response to yellow fever if the lower limit of the 95% confidence interval for the difference in proportions excludes -0.10 (-10%). Confidence Intervals are calculated using the Miettinen-Nurminen method. The difference in proportions and CI are reported as percentages (number of infants per 100).|Difference in proportions|-1.9|||||TWO_SIDED|95.0|-4.2|0.6||||||For this comparison, the proportion of infants with a seroprotective response to yellow fever vaccine in the MenACWY-TT arm is subtracted from the proportion of infants with a seroprotective response to yellow fever vaccine in the NmCV-5 arm to determine the difference in proportions.||0.6|-4.2|
71837718|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
71671579|NCT02612623|142861079|OTHER||Percentage Change|-74.0|||||TWO_SIDED|95.0|-95.0|34.7|||||100 x \[(Exponent of LSM Difference) minus 1\]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.||34.7|-95.0|
71671580|NCT03971071|142861120|SUPERIORITY||Common odds ratio|1.37||||0.13|TWO_SIDED|95.0|0.92|2.05|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.05|0.92|0.13
71671581|NCT03971071|142861120|SUPERIORITY||Common odds ratio|2.01|||<|0.001|TWO_SIDED|95.0|1.33|3.05|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.05|1.33|<0.001
71671582|NCT03971071|142861121|SUPERIORITY||Least squares mean difference|-1.23||||0.033|TWO_SIDED|95.0|-2.35|-0.1||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.10|-2.35|0.033
71671583|NCT03971071|142861121|SUPERIORITY||Least squares mean difference|-2.74|||<|0.001|TWO_SIDED|95.0|-3.87|-1.62||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-1.62|-3.87|<0.001
71789167|NCT00127712|143076024|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71671584|NCT03971071|142861122|SUPERIORITY||Common odds ratio|1.62||||0.019|TWO_SIDED|95.0|1.08|2.43|||Cochran-Mantel-Haenszel||Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||2.43|1.08|0.019
71671585|NCT03971071|142861122|SUPERIORITY||Common odds ratio|2.63|||<|0.001|TWO_SIDED|95.0|1.75|3.96|||Cochran-Mantel-Haenszel||Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).|||3.96|1.75|<0.001
71789168|NCT00127712|143076025|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71837719|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|1.2|||||TWO_SIDED|95.0|1.0|1.6|||||NmCV-5 divided by MenACWY-TT|For serogroup A, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.6|1.0|
71671586|NCT03971071|142861123|SUPERIORITY||Least squares mean difference|-3.25||||0.007|TWO_SIDED|95.0|-5.62|-0.88||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.88|-5.62|0.007
71671587|NCT03971071|142861123|SUPERIORITY||Least squares mean difference|-2.13||||0.075|TWO_SIDED|95.0|-4.48|0.22||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||0.22|-4.48|0.075
71789169|NCT00127712|143076026|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71789170|NCT00127712|143076027|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
71789171|NCT02642614|143076029|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.59|STANDARD_ERROR_OF_MEAN|0.51||0.154|TWO_SIDED|90.0|0.93|2.72|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 5 milligram BI 1026706 divided by Placebo."|Adjusted means were calculated by exponentiating Least Square (LS) means of corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive pharmacokinetic (PK) sub-study participation and Multiple-breath washout (MBW) sub-study participation)||2.72|0.93|0.1540
71789172|NCT02642614|143076029|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.58|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|90.0|0.94|2.65|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 25 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.65|0.94|0.1430
71789173|NCT02642614|143076029|SUPERIORITY_OR_OTHER||Ratio of adjusted mean|1.44|STANDARD_ERROR_OF_MEAN|0.45||0.2398|TWO_SIDED|90.0|0.86|2.41|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 100 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)||2.41|0.86|0.2398
71789174|NCT04615923|143076045|SUPERIORITY||Disease Rate Ratio|0.99|STANDARD_DEVIATION|0.103|||TWO_SIDED|95.0|0.801|1.207||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. Pridopidine slowed progression) was (0.5475). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.207|0.801|
71789175|NCT04615923|143076047|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.334||0.78|TWO_SIDED|95.0|-0.75|0.57|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.57|-0.75|0.78
71789176|NCT04615923|143076048|SUPERIORITY||Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.217||0.6594|TWO_SIDED|95.0|-0.33|0.52|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.52|-0.33|0.6594
71789177|NCT04615923|143076049|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|1.745||0.7918|TWO_SIDED|95.0|-3.89|2.96|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||2.96|-3.89|0.7918
71789178|NCT04615923|143076050|SUPERIORITY||Median Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.426||0.9903|TWO_SIDED|95.0|-0.83|0.84|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||0.84|-0.83|0.9903
71789179|NCT04615923|143076051|SUPERIORITY|Analysis performed using interval-censored survival analysis. This type of model accommodates interval censoring between ALSFRS-R assessments|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.69|1.27|||Regression, Cox|Interval censored cox model adjusted for time since symptom onset, pre-baseline change in ALSFRS-R, baseline use of edaravone, riluzole, and neudexta||||1.27|0.69|
71789180|NCT04615923|143076052|SUPERIORITY||Mean Difference (Net)|-1.78|STANDARD_ERROR_OF_MEAN|3.285||0.5888|TWO_SIDED|95.0|-8.23|4.67|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Pridopidine 24-week change from baseline relative to placebo 24-week change from baseline.|||4.67|-8.23|0.5888
71789181|NCT04615923|143076053|SUPERIORITY|||||||0.969|||||||Log Rank|||||||0.9690
71789182|NCT02282020|143076054|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.4|4.58|||Regression, Logistic|Model includes a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months)|An odds ratio \>1 favours the olaparib arm|||4.58|1.40|0.002
71837720|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.6|0.4|
71789183|NCT02282020|143076055|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.013|TWO_SIDED|95.0|0.43|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.43|0.013
71789184|NCT02282020|143076056|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.229|TWO_SIDED|95.0|0.56|1.15||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.15|0.56|0.229
71789185|NCT02282020|143076057|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.714|TWO_SIDED|95.0|0.76|1.49||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.49|0.76|0.714
71837721|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|0.4|||||TWO_SIDED|95.0|0.3|0.5|||||NmCV-5 divided by MenACWY-TT|For serogroup C, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||0.5|0.3|
71837722|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.6|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.6|
71892404|NCT01381094|143306454|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0004
71671588|NCT03971071|142861124|SUPERIORITY||Least squares mean difference|-2.61||||0.028|TWO_SIDED|95.0|-4.92|-0.29||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.29|-4.92|0.028
71671589|NCT03971071|142861124|SUPERIORITY||Least squares mean difference|-2.37||||0.043|TWO_SIDED|95.0|-4.67|-0.07||Nominal p-value is presented without multiplicity adjustment.|Linear Mixed Model||Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.|||-0.07|-4.67|0.043
71671590|NCT03810092|142861147|OTHER||Odds Ratio, log|-0.04||||0.05|TWO_SIDED|95.0|-0.55|0.42|||Regression, Linear|||Relationship between ADL score evolution and hemoglobine rate, in the no transfusion group||0.42|-0.55|0.05
71671591|NCT03810092|142861147|OTHER||Odds Ratio, log|0.39||||0.05|TWO_SIDED|95.0|-1.0|2.2|||Regression, Logistic|||Relationship between ADL score evolution and hemoglobine rate, in the transfusion group||2.2|-1|0.05
71671592|NCT02816736|142861148|SUPERIORITY||ratio of the AUCs|0.95||||0.45|TWO_SIDED|95.0|0.84|1.08|||Regression, Linear|||AUC was normalized for time; With the log-scale, the value of 0 indicates, on average, no change in NTproBNP from baseline.||1.08|0.84|0.45
71671593|NCT02816736|142861149|SUPERIORITY||Mean Difference (Net)|-11.22||||0.15|TWO_SIDED|95.0|-26.4|3.97|||general linear model|||||3.97|-26.4|0.15
71671594|NCT02816736|142861150|SUPERIORITY||Odds Ratio (OR)|1.14||||0.51|TWO_SIDED|95.0|0.78|1.68|||ordinal logistic regression|||||1.68|0.78|0.51
71671595|NCT02816736|142861151|SUPERIORITY||Odds Ratio (OR)|1.55||||0.16|TWO_SIDED|95.0|0.84|2.87|||Regression, Logistic|||||2.87|0.84|0.16
71671596|NCT02816736|142861152|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.34|2.91|||Regression, Logistic|||||2.91|0.34|0.99
71671597|NCT02816736|142861153|SUPERIORITY||Odds Ratio (OR)|2.05||||0.035|TWO_SIDED|95.0|1.05|4.0|||Regression, Logistic|||||4.00|1.05|0.035
71671598|NCT01139775|142861164|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.96|||||TWO_SIDED||||||||Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.|The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.||||
71671599|NCT01139775|142861166|SUPERIORITY_OR_OTHER|||||||0.2294|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Log Rank|||||||0.2294
71671600|NCT01139775|142861167|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0824
71671601|NCT01139775|142861168|SUPERIORITY_OR_OTHER|||||||0.4924|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Wilcoxon (Mann-Whitney)|||||||0.4924
71671602|NCT01139775|142861179|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED|||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared|||||||0.0946
71789186|NCT02282020|143076058|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.005|TWO_SIDED|95.0|0.41|0.85||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \<1 favours the olaparib arm|||0.85|0.41|0.005
71789187|NCT02282020|143076059|SUPERIORITY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.69||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.69|0.35|<0.001
71789188|NCT02282020|143076060|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.089|TWO_SIDED|95.0|0.53|1.05||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.05|0.53|0.089
71789189|NCT02282020|143076061|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.14|0.29||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.29|0.14|<0.001
71789190|NCT02282020|143076064|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.108|TWO_SIDED|95.0|-0.5|5.5|||Mixed Models Analysis|Model includes factors for patient, treatment, visit, treatment by visit interaction, baseline TOI score and baseline TOI score by visit interaction.||||5.5|-0.5|0.108
71789191|NCT02282020|143076065|SUPERIORITY||Odds Ratio (OR)|2.24||||0.092|TWO_SIDED|95.0|0.88|6.86||Estimated from an unadjusted logistic regression model|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||6.86|0.88|0.092
71789192|NCT02282020|143076066|SUPERIORITY||Odds Ratio (OR)|2.4||||0.004|TWO_SIDED|95.0|1.32|4.39||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Regression, Logistic||An odds ratio \> 1 favours the olaparib arm|||4.39|1.32|0.004
71671603|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.89|||||TWO_SIDED|95.0|0.68|1.16|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.16|0.68|
71671604|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.95|||||TWO_SIDED|95.0|0.73|1.23|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.73|
71671605|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.81|1.38|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.38|0.81|
71671606|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.2|||||TWO_SIDED|95.0|0.9|1.6|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.6|0.9|
71789193|NCT02282020|143076067|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.014|TWO_SIDED|95.0|0.42|0.91||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.91|0.42|0.014
71789194|NCT02282020|143076068|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.213|TWO_SIDED|95.0|0.56|1.14||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.14|0.56|0.213
71789195|NCT02282020|143076069|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.699|TWO_SIDED|95.0|0.76|1.51||Determined using a log-rank test with a factor for time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.51|0.76|0.699
71789196|NCT02282020|143076070|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001|TWO_SIDED|95.0|0.12|0.27||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.27|0.12|<0.001
71789197|NCT02282020|143076071|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.66||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||0.66|0.33|<0.001
71789198|NCT02282020|143076072|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.055|TWO_SIDED|95.0|0.51|1.01||Model included factors for number of prior chemotherapy regimens received for ovarian cancer (2 or 3 prior lines vs 4 or more lines) and time to disease progression after the end of last platinum based chemotherapy (6-12 months vs \> 12 months).|Log Rank||A hazard ratio \< 1 favours the olaparib arm|||1.01|0.51|0.055
71837723|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|1.6|||||TWO_SIDED|95.0|1.1|2.1|||||NmCV-5 divided by MenACWY-TT|For serogroup W, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||2.1|1.1|
71789199|NCT03227029|143076127|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|46.0|80.0|||||Proportions of study participants were calculated and presented with 90% exact confidence intervals. This highlights that we are 95% sure that the true proportion is not higher that the upper limit of the confidence interval.|||80|46|
71789200|NCT03227029|143076127|OTHER||% vaccine recipients with solicited AEs|84.0|||||TWO_SIDED|90.0|67.0|94.0||||||||94|67|
71789201|NCT03227029|143076127|OTHER||% placebo recipients with solicited AEs|58.0|||||TWO_SIDED|90.0|32.0|82.0||||||||82|32|
71789202|NCT03227029|143076128|OTHER||% vaccine recipients with usolicited AEs|36.0|||||TWO_SIDED|90.0|20.0|54.0||||||||54|20|
71789203|NCT03227029|143076128|OTHER||% vaccine recipients with usolicited AEs|52.0|||||TWO_SIDED|90.0|34.0|69.0||||||||69|34|
71789204|NCT03227029|143076128|OTHER||% placebo recipients with usolicited AEs|42.0|||||TWO_SIDED|90.0|18.0|68.0||||||||68|18|
71789205|NCT03227029|143076130|OTHER||% recipients infected with vaccine virus|88.0|||||TWO_SIDED|90.0|72.0|97.0||||||||97|72|
71789206|NCT03227029|143076130|OTHER||% recipients infected with vaccine virus|96.0|||||TWO_SIDED|90.0|82.0|100.0||||||||100|82|
71789207|NCT03227029|143076130|OTHER||% recipients infected with vaccine virus|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
71756896|NCT05465317|143017418|OTHER||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.52|0.86|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.86|0.52|0.001
71756897|NCT05465317|143017418|OTHER||Hazard Ratio (HR)|0.79||||0.008|TWO_SIDED|95.0|0.67|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.67|0.008
71756898|NCT05465317|143017419|OTHER||Hazard Ratio (HR)|0.74||||0.005|TWO_SIDED|95.0|0.6|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.60|0.005
71756899|NCT05465317|143017419|OTHER||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.41|0.91|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.91|0.41|0.02
71756900|NCT05465317|143017419|OTHER||Hazard Ratio (HR)|0.8||||0.08|TWO_SIDED|95.0|0.63|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.63|0.08
71756901|NCT05465317|143017420|OTHER||Hazard Ratio (HR)|0.68||||0.05|TWO_SIDED|95.0|0.46|1.0|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.00|0.46|0.05
71756902|NCT05465317|143017420|OTHER||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.35|1.09|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.09|0.35|0.09
71756903|NCT05465317|143017420|OTHER||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.29|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.29|0.43|0.30
71756904|NCT05465317|143017421|OTHER||Hazard Ratio (HR)|0.73||||0.11|TWO_SIDED|95.0|0.49|1.08|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.08|0.49|0.11
71756905|NCT05465317|143017421|OTHER||Hazard Ratio (HR)|0.63||||0.12|TWO_SIDED|95.0|0.35|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.35|0.12
71756906|NCT05465317|143017421|OTHER||Hazard Ratio (HR)|0.84||||0.52|TWO_SIDED|95.0|0.5|1.42|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.42|0.50|0.52
71756907|NCT05465317|143017423|OTHER||Hazard Ratio (HR)|0.84||||0.02|TWO_SIDED|95.0|0.72|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.72|0.02
71789208|NCT03227029|143076133|OTHER||% with >=4 fold rise in RSV-PRNT|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
71789209|NCT03227029|143076133|OTHER||% with >=4 fold rise in RSV-PRNT|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
71789210|NCT03227029|143076133|OTHER||% with >=4 fold rise in RSV-PRNT|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
71789211|NCT03227029|143076133|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
71789212|NCT03227029|143076133|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
71892405|NCT01381094|143306454|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
71892406|NCT01381094|143306454|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71892407|NCT01381094|143306454|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0002
71892408|NCT01381094|143306455|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71892409|NCT01381094|143306455|SUPERIORITY||||||=|0.0043|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0043
71892410|NCT01381094|143306455|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71892411|NCT01381094|143306455|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71892412|NCT01381094|143306455|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
71677195|NCT04143594|142873005|SUPERIORITY||Difference in percentage|-6.7||||0.3142|TWO_SIDED|95.0|-20.7|7.3||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||7.3|-20.7|0.3142
71789213|NCT03227029|143076134|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
71892413|NCT01381094|143306456|SUPERIORITY||||||=|0.0027|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0027
71892414|NCT01381094|143306456|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71892415|NCT01381094|143306456|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0001
71892416|NCT01381094|143306456|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||<0.0001
71892417|NCT01381094|143306456|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group.||||=0.0005
71789214|NCT03227029|143076134|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
71789215|NCT03227029|143076135|OTHER||% with >=4 fold rise in RSV F protein|60.0|||||TWO_SIDED|90.0|42.0|76.0||||||||76|42|
71892418|NCT01381094|143306462|SUPERIORITY||||||=|0.6051|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6051
71892419|NCT01381094|143306462|SUPERIORITY||||||=|0.5197|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5197
71892420|NCT01381094|143306462|SUPERIORITY||||||=|0.1073|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1073
71789216|NCT03227029|143076135|OTHER||% with >=4 fold rise in RSV F protein|92.0|||||TWO_SIDED|90.0|76.0|98.0||||||||98|76|
71789217|NCT03227029|143076135|OTHER||% with >=4 fold rise in RSV F protein|0.0|||||TWO_SIDED|90.0|0.0|22.0||||||||22|0|
71789218|NCT03227029|143076135|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
71789219|NCT03227029|143076135|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.01
71671607|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.33|||||TWO_SIDED|95.0|1.0|1.77|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.77|1|
71837724|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.6|1.0|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.0|0.6|
71837725|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||NmCV-5 divided by MenACWY-TT|For serogroup Y, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1.3|0.8|
71837726|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|1511.1|||||TWO_SIDED|95.0|1169.5|1952.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1952.4|1169.5|
71892421|NCT01381094|143306462|SUPERIORITY||||||=|0.1321|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1321
71892422|NCT01381094|143306462|SUPERIORITY||||||=|0.4358|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.4358
71892423|NCT01381094|143306462|SUPERIORITY||||||=|0.8109|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8109
71892424|NCT01381094|143306462|SUPERIORITY||||||=|0.2575|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2575
71892425|NCT01381094|143306462|SUPERIORITY||||||=|0.8361|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8361
71756908|NCT05465317|143017423|OTHER||Hazard Ratio (HR)|0.82||||0.12|TWO_SIDED|95.0|0.65|1.05|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.05|0.65|0.12
71789220|NCT03227029|143076136|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
71756909|NCT05465317|143017423|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.70|0.10
71789221|NCT03227029|143076136|SUPERIORITY||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Wilcoxon test was used to test the hypothesis that antibody levels at Day 56 were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.01
71789222|NCT05081011|143076159|OTHER|||||||0.006||||||A p-value of 0.05 would be considered statistically significant|Log Rank|||||||0.006
71756910|NCT05465317|143017424|OTHER||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.72|1.11|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.11|0.72|0.32
71756911|NCT05465317|143017424|OTHER||Hazard Ratio (HR)|0.9||||0.5|TWO_SIDED|95.0|0.65|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.65|0.50
71756912|NCT05465317|143017424|OTHER||Hazard Ratio (HR)|0.91||||0.5|TWO_SIDED|95.0|0.68|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.68|0.50
71756913|NCT05465317|143017425|OTHER||Hazard Ratio (HR)|0.75||||0.005|TWO_SIDED|95.0|0.62|0.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.92|0.62|0.005
71756914|NCT05465317|143017425|OTHER||Hazard Ratio (HR)|0.69||||0.03|TWO_SIDED|95.0|0.49|0.96|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.96|0.49|0.03
71789223|NCT05081011|143076160|OTHER||Mean Difference (Final Values)|32.7||||0.01|TWO_SIDED|95.0|8.0|57.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||57.4|8.0|0.01
71789224|NCT05081011|143076161|OTHER||Mean Difference (Final Values)|-3.6||||0.03|TWO_SIDED|95.0|-6.8|-0.4||A p-value of 0.05 would be considered statistically significant.|Welch 2-sample method|||||-0.4|-6.8|0.03
71789225|NCT05081011|143076162|OTHER||Mean Difference (Final Values)|1.4||||0.06|TWO_SIDED|95.0|-0.03|2.8|||Welch 2-sample method|||||2.8|-0.03|0.06
71789226|NCT05081011|143076163|OTHER||Mean Difference (Final Values)|1.0||||0.46|TWO_SIDED|95.0|-1.6|3.5|||Welch 2-sample method|||||3.5|-1.6|0.46
71789227|NCT05081011|143076164|OTHER||Mean Difference (Final Values)|0.56||||0.005|TWO_SIDED|95.0|0.21|0.91|||2-sample test|2-sample test for equality of proportions with Yates continuity correction|Comparison of percentage (proportion) of participants achieving glycemic control.|Comparison of percentage (proportion) of participants achieving glycemic control.||0.91|0.21|0.005
71789228|NCT05081011|143076165|OTHER||Mean Difference (Final Values)|-68.9||||0.001|TWO_SIDED|95.0|-107.1|-30.1|||Welch 2-sample method|||||-30.1|-107.1|0.001
71789229|NCT01949051|143076167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.943|-0.756|||Mixed Model ANOVA|||||-0.756|-1.943|<0.0001
71789230|NCT01949051|143076167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.118||||0.0003|TWO_SIDED|95.0|-1.712|-0.525|||Mixed Model ANOVA|||||-0.525|-1.712|0.0003
71789231|NCT01949051|143076167|NON_INFERIORITY_OR_EQUIVALENCE|Levocabastine OD would be declared as non-inferior to levocabastine BID if upper limit of 95% confidence interval of the treatment difference estimate (OD vs BD) was less than 1|Mean Difference (Final Values)|0.231|||||TWO_SIDED|95.0|-0.361|0.823||||||||0.823|-0.361|
71789232|NCT00923598|143076236|EQUIVALENCE|A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.|Mean Difference (Final Values)|3.0||||0.05|TWO_SIDED|95.0|-10.0|17.0|||Fisher Exact|||||17|-10|0.05
71837727|NCT05093829|143182442|OTHER||Ratio of geometric mean titers|767.3|||||TWO_SIDED|95.0|553.2|1064.4|||||NmCV-5 divided by MenACWY-TT|For serogroup X, the point and interval estimates for the Geometric Mean Titer (GMT) ratio will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMT ratio of rSBA titers at Day 29 is calculated for the NmCV-5 arm relative to the MenACWY-TT arm.||1064.4|553.2|
71789233|NCT00828347|143076244|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Fisher Exact|||||||0.036
71789234|NCT01129960|143076245|SUPERIORITY_OR_OTHER|||||||0.3726|||||||Dunnett's test (analysis of covariance)|||||||0.3726
71789235|NCT01129960|143076245|SUPERIORITY_OR_OTHER|||||||0.8034|||||||Dunnett's test (analysis of covariance)|||||||0.8034
71789236|NCT01129960|143076245|SUPERIORITY_OR_OTHER|||||||0.1391|||||||Dunnett's test (analysis of covariance)|||||||0.1391
71837728|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|2756.4|||||TWO_SIDED|95.0|1976.3|3844.5|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3844.5|1976.3|
71837729|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|2506.9|||||TWO_SIDED|95.0|1404.0|4476.1|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4476.1|1404.0|
71837730|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1179.0|||||TWO_SIDED|95.0|709.8|1958.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1958.6|709.8|
71789237|NCT02622321|143076254|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.057|0.277||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (less than \[\<\] 9 or greater than or equal to \[\>/=\] 9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.277|0.057|<0.0001
71789238|NCT02622321|143076255|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.2|||<|0.0001|TWO_SIDED|95.0|0.102|0.375||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.375|0.102|<0.0001
71837731|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1096.2|||||TWO_SIDED|95.0|513.4|2340.6|||||Day 29 divided by Day 1|For serogroup A, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2340.6|513.4|
71837732|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|288.7|||||TWO_SIDED|95.0|212.6|392.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||392.0|212.6|
71837733|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|654.5|||||TWO_SIDED|95.0|385.5|1111.0|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1111.0|385.5|
71837734|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|287.9|||||TWO_SIDED|95.0|213.9|387.5|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||387.5|213.9|
71837735|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|834.6|||||TWO_SIDED|95.0|496.7|1402.3|||||Day 29 divided by Day 1|For serogroup C, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1402.3|496.7|
71837736|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1068.4|||||TWO_SIDED|95.0|683.3|1670.6|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1670.6|683.3|
71837737|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1933.1|||||TWO_SIDED|95.0|1224.7|3051.1|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3051.1|1224.7|
71837738|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|3163.1|||||TWO_SIDED|95.0|2247.5|4451.7|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||4451.7|2247.5|
71837739|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1524.1|||||TWO_SIDED|95.0|913.5|2543.0|||||Day 29 divided by Day 1|For serogroup W, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2543.0|913.5|
71837740|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|799.4|||||TWO_SIDED|95.0|532.9|1199.4|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1199.4|532.9|
71789239|NCT02622321|143076256|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.055|0.218||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.218|0.055|<0.0001
71671608|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.68|1.2|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.2|0.68|
71756915|NCT05465317|143017425|OTHER||Hazard Ratio (HR)|0.8||||0.074|TWO_SIDED|95.0|0.63|1.02|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.02|0.63|0.074
71756916|NCT05465317|143017426|OTHER||Hazard Ratio (HR)|1.03||||0.46|TWO_SIDED|95.0|0.95|1.12|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.12|0.95|0.46
71756917|NCT05465317|143017426|OTHER||Hazard Ratio (HR)|1.04||||0.63|TWO_SIDED|95.0|0.9|1.2|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.20|0.90|0.63
71756918|NCT05465317|143017426|OTHER||Hazard Ratio (HR)|1.03||||0.52|TWO_SIDED|95.0|0.94|1.14|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.14|0.94|0.52
71756919|NCT05465317|143017427|OTHER||Hazard Ratio (HR)|0.81||||0.007|TWO_SIDED|95.0|0.7|0.94|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.94|0.70|0.007
71756920|NCT05465317|143017427|OTHER||Hazard Ratio (HR)|0.74||||0.03|TWO_SIDED|95.0|0.57|0.97|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||0.97|0.57|0.03
71756921|NCT05465317|143017427|OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.71|1.03|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.03|0.71|0.10
71756922|NCT05465317|143017428|OTHER||Hazard Ratio (HR)|1.37||||0.15|TWO_SIDED|95.0|0.89|2.1|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.10|0.89|0.15
71756923|NCT05465317|143017428|OTHER||Hazard Ratio (HR)|1.05||||0.93|TWO_SIDED|95.0|0.4|2.72|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.72|0.40|0.93
71756924|NCT05465317|143017428|OTHER||Hazard Ratio (HR)|1.47||||0.113|TWO_SIDED|95.0|0.91|2.38|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.38|0.91|0.113
71756925|NCT05465317|143017429|OTHER||Hazard Ratio (HR)|0.9||||0.43|TWO_SIDED|95.0|0.71|1.16|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.16|0.71|0.43
71756926|NCT05465317|143017429|OTHER||Hazard Ratio (HR)|0.8||||0.32|TWO_SIDED|95.0|0.51|1.24|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.24|0.51|0.32
71756927|NCT05465317|143017429|OTHER||Hazard Ratio (HR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.30|0.71|0.81
71756928|NCT05465317|143017430|OTHER||Hazard Ratio (HR)|0.93||||0.69|TWO_SIDED|95.0|0.65|1.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.33|0.65|0.69
71789240|NCT02622321|143076257|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.031|0.198||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.198|0.031|<0.0001
71671609|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.63|0.97|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||0.97|0.63|
71671610|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||TWO_SIDED|95.0|0.86|1.13|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.86|
71671611|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.35|||||TWO_SIDED|95.0|1.09|1.67|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.67|1.09|
71671612|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.02|0.61|
71671613|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.91|||||TWO_SIDED|95.0|0.7|1.18|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.18|0.7|
71756929|NCT05465317|143017430|OTHER||Hazard Ratio (HR)|0.93||||0.82|TWO_SIDED|95.0|0.51|1.7|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.70|0.51|0.82
71756930|NCT05465317|143017430|OTHER||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.45|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.45|0.60|0.76
71756931|NCT05465317|143017431|OTHER||Hazard Ratio (HR)|0.68||||0.39|TWO_SIDED|95.0|0.29|1.62|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.62|0.29|0.39
71671614|NCT00450437|142861215|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.16|||||TWO_SIDED|95.0|0.89|1.5|||ANOVA|||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).||1.5|0.89|
71756932|NCT05465317|143017431|OTHER||Hazard Ratio (HR)|0.46||||0.34|TWO_SIDED|95.0|0.09|2.27|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.27|0.09|0.34
71756933|NCT05465317|143017431|OTHER||Hazard Ratio (HR)|0.82||||0.72|TWO_SIDED|95.0|0.29|2.33|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.33|0.29|0.72
71756934|NCT05465317|143017432|OTHER||Hazard Ratio (HR)|0.84||||0.62|TWO_SIDED|95.0|0.43|1.66|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.66|0.43|0.62
71671615|NCT00450437|142861216|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|8.0|||||TWO_SIDED|95.0|3.0|14.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||14|3|
71671616|NCT00450437|142861216|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|-2|
71756935|NCT05465317|143017432|OTHER||Hazard Ratio (HR)|0.59||||0.31|TWO_SIDED|95.0|0.21|1.64|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.64|0.21|0.31
71756936|NCT05465317|143017432|OTHER||Hazard Ratio (HR)|1.16||||0.76|TWO_SIDED|95.0|0.46|2.92|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.92|0.46|0.76
71756937|NCT05465317|143017433|OTHER||Hazard Ratio (HR)|1.72|||<|0.001|TWO_SIDED|95.0|1.58|1.88|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.88|1.58|<0.001
71756938|NCT05465317|143017433|OTHER||Hazard Ratio (HR)|1.84|||<|0.001|TWO_SIDED|95.0|1.48|2.3|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||2.30|1.48|<0.001
71756939|NCT05465317|143017433|OTHER||Hazard Ratio (HR)|1.7|||<|0.001|TWO_SIDED|95.0|1.54|1.87|||Regression, Cox||Ratio calculated as Empagliflozin/DPP4i|Outcomes were assessed using Cox proportional hazards (PH) models in a 2-arm comparison. The analysis included all patients with a valid overlap weight and was performed using the reweighted population. The main analysis assessed outcomes while patients remain on initial treatment.||1.87|1.54|<0.001
71758546|NCT02205736|143019222|SUPERIORITY|||||||0.0026||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 13 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0026
71671617|NCT00450437|142861216|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|6.0|18.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||18|6|
71671618|NCT00450437|142861216|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|27.0|||||TWO_SIDED|95.0|20.0|33.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||33|20|
71671619|NCT00450437|142861217|NON_INFERIORITY_OR_EQUIVALENCE|MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction \[MenACWY minus Menactra\] was less than 6%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|2.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.||2|-1|
71671620|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
71756940|NCT03592186|143017445|SUPERIORITY|In zero-inflated distributions, two outcomes can be specified: 1) probability of being an excess zero (falling outside expected negative binomial distribution), and 2) count value, if not an excess zero. Our focal effect of interest was Time\*Condition in the count distribution, i.e. effect of condition over time on predicting the percent of days used greater than zero.|Risk Ratio (RR)|1.15|STANDARD_ERROR_OF_MEAN|2.57||0.12|TWO_SIDED|95.0|0.97|1.36|||Mixed Models Analysis|||Mixed models with zero-inflated distributions evaluated whether there was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used. We tested the primary outcome (percent of days of use over the past 90 days, adjusted for time in a controlled environment) for overall number of days of use.||1.36|.97|.12
71756941|NCT03592186|143017446|SUPERIORITY||Risk Ratio (RR)|-0.1|STANDARD_ERROR_OF_MEAN|0.34||0.19|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||Mixed models using a linear distribution evaluated whether change in substance-related problems differed by condition. The focal effect was a Time\*Condition interaction, using data from the baseline, 12-week, and 24-week assessments. Full maximum likelihood estimation was used.||.07|-.34|.19
71756942|NCT03592186|143017447|SUPERIORITY||Chi-square value|0.01||||0.92|TWO_SIDED||||||Chi-squared|||Comparison of the count of positive urine screens by condition at 12 weeks||||.92
71756943|NCT00817843|143017451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.295||0.766||95.0|||||ANOVA|||"Between treatment difference in the change in FMD from the fasting to the post-fat load state.~Null hypothesis was that combination therapy (simvastatin/ezetimibe) would protect the FMD in the post-fat load phase and would therefore be associated with a smaller drop in FMD~Power calculation was based on the results from a pilot study. To detect a 1.0% difference between treatments with a SD of 2.7% and a power of 90% (alfa 0.05, two tailed) 80 evaluable patients were needed."||||0.766
71756944|NCT00198822|143017467|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.65||||0.05|ONE_SIDED|95.0||0.99||We set an a priori level of statistical significance of p equal to 0.05.|generalized estimating equations|RR with 95% CIs were estimated by GEE binomial regression, with a log link function and exchangeable correlation appropriate for binary data.|The vitamin A group and the Beta-carotene group were compared to the placebo group.|Sample size was based on an expected placebo group MR of 600/100,000 pregnancies, requiring 18,000 pregnancies to detect a 35% reduction in all-cause mortality, with a 5% type I error, 80% power, 1.21 design effect, 15% early pregnancy loss and 10% loss to follow-up. A mid-study DSMB analysis suggested a lower MR, leading the SS to be increased to 67,740. However, with no mortality difference evident at a DSMB meeting in Dec 2006, the trial was halted leaving 59,721 in the trial cohort.||0.99||0.05
71892426|NCT01381094|143306462|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0294
71671621|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
71756945|NCT02072668|143017489|SUPERIORITY|||||||0.6281|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.6281
71756946|NCT02072668|143017490|SUPERIORITY|||||||0.7973|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7973
71892427|NCT01381094|143306462|SUPERIORITY||||||=|0.8809|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.8809
71837741|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1469.2|||||TWO_SIDED|95.0|995.3|2168.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2168.8|995.3|
71837742|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|549.4|||||TWO_SIDED|95.0|371.8|811.8|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||811.8|371.8|
71837743|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|642.6|||||TWO_SIDED|95.0|309.2|1335.9|||||Day 29 divided by Day 1|For serogroup Y, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||1335.9|309.2|
71837744|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|2630.0|||||TWO_SIDED|95.0|2037.6|3394.6|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3394.6|2037.6|
71837745|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|2.0|||||TWO_SIDED|95.0|1.2|3.4|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.4|1.2|
71837746|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1431.2|||||TWO_SIDED|95.0|905.2|2262.9|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||2262.9|905.2|
71837747|NCT05093829|143182444|OTHER||Ratio of geometric mean titers|1.7|||||TWO_SIDED|95.0|0.9|3.3|||||Day 29 divided by Day 1|For serogroup X, the point and interval estimates for the Geometric Mean Fold Rise (GMFR) will be obtained from a back transformation (exponentiation) of the estimated mean ratio of the log-transformed rSBA titers. The GMFR from baseline to Day 29 of rSBA titers is calculated as Day 29 divided by Day 1.||3.3|0.9|
71837748|NCT05178316|143182516|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|2.175|=|0.8862|TWO_SIDED|95.0|-3.98|4.6|||Mixed Models Analysis|||||4.60|-3.98|=0.8862
71837749|NCT05178316|143182516|SUPERIORITY||Least squares mean difference|-0.74|STANDARD_ERROR_OF_MEAN|1.817|=|0.6832|TWO_SIDED|95.0|-4.32|2.84|||Mixed Models Analysis|||||2.84|-4.32|=0.6832
71837750|NCT05178316|143182517|SUPERIORITY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.204|=|0.4522|TWO_SIDED|95.0|-0.55|0.25|||Mixed Models Analysis|||||0.25|-0.55|=0.4522
71892428|NCT01381094|143306462|SUPERIORITY||||||=|0.4971|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4971
71837751|NCT05178316|143182517|SUPERIORITY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.169|=|0.2032|TWO_SIDED|95.0|-0.55|0.12|||Mixed Models Analysis|||||0.12|-0.55|=0.2032
71837752|NCT05178316|143182518|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.165|=|0.717|TWO_SIDED|95.0|-0.38|0.26|||Mixed Models Analysis|||||0.26|-0.38|=0.7170
71837753|NCT05178316|143182518|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.137|=|0.2423|TWO_SIDED|95.0|-0.43|0.11|||Mixed Models Analysis|||||0.11|-0.43|=0.2423
71837754|NCT03457142|143182520|OTHER|No formal test, a confidence interval estimate for the grade 3+ treatment related AE rate.|grade 3+ treatment related AE rate|0.33|||||TWO_SIDED|90.0|0.17|0.54||||||||0.54|0.17|
71837755|NCT01333969|143182525|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.043|TWO_SIDED|95.0|-1.4|-0.02|||GEE|Regression analysis using the generalized estimating equations (GEE) method to compare the changes over time in VAS scores at rest and with exercise||||-0.02|-1.40|.043
71837756|NCT01333969|143182526|OTHER||Mean Difference (Final Values)|0.043||||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
71837757|NCT01333969|143182527|SUPERIORITY||Mean Difference (Final Values)|0.584||||0.584|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.584
71837758|NCT01333969|143182528|SUPERIORITY||Mean Difference (Final Values)|0.763||||0.763|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.763
71837759|NCT01333969|143182529|SUPERIORITY||Mean Difference (Final Values)|0.602||||0.602|TWO_SIDED||||||GEE|Regression analyses based on the generalized estimating equations (GEE) method||||||.602
71837760|NCT01333969|143182530|SUPERIORITY||Mean Difference (Final Values)|0.8656||||0.8656|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8656
71837761|NCT01333969|143182531|SUPERIORITY||Mean Difference (Final Values)|0.8422||||0.8422|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.8422
71837762|NCT01333969|143182532|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
71837763|NCT01333969|143182533|SUPERIORITY||Mean Difference (Final Values)|0.526||||0.526|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.526
71837764|NCT04760678|143182549|OTHER|Fisher's exact test||||||0.107|||||||Fisher Exact|||||||0.107
71837765|NCT01748448|143182564|SUPERIORITY||Cox Proportional Hazard|1.27|||=|0.324|TWO_SIDED|95.0|0.79|2.03|||Fisher Exact|||||2.03|0.79|= 0.324
71892429|NCT01381094|143306462|SUPERIORITY||||||=|0.3994|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3994
71892430|NCT01381094|143306462|SUPERIORITY||||||=|0.5022|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.5022
71789241|NCT02622321|143076258|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.11||||0.005|TWO_SIDED|95.0|0.025|0.52||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.520|0.025|0.0050
71789242|NCT02622321|143076259|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.119|0.435||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.||0.435|0.119|<0.0001
71837766|NCT02907099|143182571|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
71837767|NCT02907099|143182572|OTHER|||||||0.5|||||||t-test, 2 sided|||||||0.5
71837768|NCT05516147|143182580|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.|t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Constructive Engagement mean of 0.85 for standard programming.||||<.01
71837769|NCT05516147|143182581|SUPERIORITY||||||<|0.01||||||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Passive Engagement mean of 1.06 for standard programming.||||<.01
71837770|NCT05516147|143182582|SUPERIORITY|||||||0.06||||||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.|t-test, 2 sided|A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||A one-sample t-test was used to assess whether the mean was different from a known Other Engagement mean of 0.42 for standard programming.||||0.06
71837771|NCT05516147|143182583|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||A one-sample t-test was used to assess whether the mean was different from a known Non Engagement mean of 0.40 for standard programming.||||<.01
71837772|NCT05516147|143182585|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||baseline score vs. post-treatment, paired sample t-test||||0.81
71837773|NCT05516147|143182586|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.20
71837774|NCT05516147|143182587|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.83
71837775|NCT05516147|143182588|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||baseline vs. post-treatment, paired sample t-test||||0.320
71837776|NCT00999804|143182598|SUPERIORITY_OR_OTHER_LEGACY||proportion of pCR|0.25|||||TWO_SIDED||||||||No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.|"The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.~The analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants."||||
71837777|NCT00999804|143182599|SUPERIORITY_OR_OTHER_LEGACY||proportion of patients with AE|0.72|||||TWO_SIDED||||||||61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.|This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.||||
71837778|NCT00999804|143182600|SUPERIORITY_OR_OTHER_LEGACY||proportion of tpCR in 24 weeks arm|0.1|||||TWO_SIDED|||||||||No comparison between the two arms is required.||||
71677196|NCT04143594|142873005|SUPERIORITY||Difference in percentage|-7.2||||0.3009|TWO_SIDED|95.0|-21.3|6.8||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.8|-21.3|0.3009
71837779|NCT00999804|143182601|SUPERIORITY_OR_OTHER_LEGACY||proportion of CR+PR in 24 weeks arm|0.69|||||TWO_SIDED|||||||||No comparison between the 2 arm is required for this study.||||
71837780|NCT05386758|143182608|OTHER||Gemetric Mean Ratio (GMR)|1.24|||||TWO_SIDED|90.0|0.94|1.64||||||||1.64|0.94|
71837781|NCT05386758|143182609|OTHER||Geometric Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.9|1.62||||||||1.62|0.90|
71837782|NCT05908344|143182614|OTHER|Effect size determination|Cohen's d|-0.24|||||TWO_SIDED|||||||||Comparison for NREM1 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design||||
71837783|NCT05908344|143182614|OTHER|Effect size determination|Cohen's d|-0.15|||||TWO_SIDED|||||||||Comparison for NREM2 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71789243|NCT02622321|143076260|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.21||||0.0003|TWO_SIDED|95.0|0.089|0.486||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.||0.486|0.089|0.0003
71837784|NCT05908344|143182614|OTHER|Effect size determination|Cohen's d|0.69|||||TWO_SIDED|||||||||Comparison for NREM3 minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71837785|NCT05908344|143182614|OTHER|Effect size determination|Cohen's d|-0.82|||||TWO_SIDED|||||||||Comparison for REM minutes. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71837786|NCT05908344|143182615|OTHER|Effect size determination|Cohen's d|-0.04|||||TWO_SIDED|||||||||Comparison for NREM1 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71837787|NCT05908344|143182615|OTHER|Effect size determination|Cohen's d|0.24|||||TWO_SIDED|||||||||Comparison for NREM2 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71837788|NCT05908344|143182615|OTHER|Effect size determination|Cohen's d|0.8|||||TWO_SIDED|||||||||Comparison for NREM3 percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71789244|NCT02622321|143076261|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.037|0.154||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.154|0.037|<0.0001
71789245|NCT02622321|143076262|SUPERIORITY_OR_OTHER_LEGACY||ABR Ratio|0.05||||0.0002|TWO_SIDED|95.0|0.009|0.227||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant's number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (\<9 or \>/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.||0.227|0.009|0.0002
71789246|NCT02622321|143076266|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|21.55||||0.0029|TWO_SIDED|95.0|7.89|35.22||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm. Analysis was performed using Analysis of Covariance (ANCOVA).||35.22|7.89|0.0029
71789247|NCT02622321|143076267|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|14.01||||0.0019|TWO_SIDED|95.0|5.56|22.45||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||22.45|5.56|0.0019
71789248|NCT02622321|143076268|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-9.72||||0.0171|TWO_SIDED|95.0|-17.62|-1.82||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-1.82|-17.62|0.0171
71789249|NCT02622321|143076269|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.16||||0.0014|TWO_SIDED|95.0|-0.25|-0.07||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.||-0.07|-0.25|0.0014
71789250|NCT00965718|143076292|SUPERIORITY_OR_OTHER_LEGACY|||||||0.123||||||Global health status scores at baseline and final observation point were compared via a 2-sided t-test.|t-test, 2 sided|||||||0.123
71789251|NCT01958008|143076301|SUPERIORITY_OR_OTHER||Slope|1.2674|STANDARD_ERROR_OF_MEAN|0.1019|||TWO_SIDED|95.0|1.0636|1.4713|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint Cmax,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.4713|1.0636|
71789252|NCT01958008|143076302|SUPERIORITY_OR_OTHER||Slope|1.2139|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|1.0519|1.3759|||Regression, Linear|Power model that describes the functional relationship between the dose and pharmacokinetic endpoint AUC tau,ss||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model||1.3759|1.0519|
71837789|NCT05908344|143182615|OTHER|Effect size determination|Cohen's d|-0.78|||||TWO_SIDED|||||||||Comparison for REM percentage. Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71837790|NCT05908344|143182616|OTHER|Effect size determination|Cohen's d|0.11|||||TWO_SIDED|||||||||Group Selection refers to study device Condition (Active/Sham); repeated-measures design.||||
71837791|NCT06393088|143182703|SUPERIORITY|It was calculated that 24 participants randomized 1:1 between 2 arms would have at least an 85% power to detect a difference in pain relief of 30 points as measured using a Visual Analog Device. The actual difference in the mean of the change in pain level, as measured using a Visual Analog Scale, between the two independent groups is 41.67. Results of the post trial calculation was a 95.7% power to detect the difference in pain relief using 29 randomized participants.|Mean Difference (Net)|41.67|||<|0.01|TWO_SIDED|95.0|20.15|61.67||The threshold is P-value \<.0.05 for statistical significance A bootstrap N=20,000 was used for all estimates|t-test, 2 sided|||"Null Hypothesis:~There is not a statistically significant difference in nociceptive musculoskeletal pain when using an IR REHAB device when compared with a sham (placebo) device as a therapy in an approved and standardized clinical protocol."||61.67|20.15|<0.01
71677197|NCT04143594|142873005|SUPERIORITY||Difference in percentage|-7.6||||0.2859|TWO_SIDED|95.0|-21.8|6.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||6.7|-21.8|0.2859
71756947|NCT02072668|143017491|SUPERIORITY|||||||0.4442|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4442
71756948|NCT02072668|143017492|SUPERIORITY|||||||0.2545|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.2545
71756949|NCT02072668|143017498|SUPERIORITY|||||||0.4374|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4374
71756950|NCT02072668|143017499|SUPERIORITY|||||||0.347|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.3470
71756951|NCT02072668|143017500|SUPERIORITY|||||||0.0755|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0755
71756952|NCT02072668|143017502|SUPERIORITY|||||||0.0708|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0708
71756953|NCT02072668|143017503|SUPERIORITY|||||||0.4501|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.4501
71789253|NCT02028065|143076310|SUPERIORITY_OR_OTHER||Difference in incidence|5.3|||||TWO_SIDED|95.0|-0.9|10.7|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||10.7|-0.9|
71756954|NCT02072668|143017504|SUPERIORITY|||||||0.0767|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.0767
71756955|NCT02072668|143017505|SUPERIORITY|||||||0.725|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.7250
71789254|NCT02028065|143076310|SUPERIORITY_OR_OTHER||Difference in incidence|8.1|||||TWO_SIDED|95.0|1.7|14.2|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen(Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26\[4\]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).||14.2|1.7|
71789255|NCT02028065|143076311|SUPERIORITY_OR_OTHER||Difference in incidence|0.0|||||TWO_SIDED|95.0|-4.8|2.5|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||2.5|-4.8|
71789256|NCT02028065|143076311|SUPERIORITY_OR_OTHER||Difference in incidence|0.7|||||TWO_SIDED|95.0|-4.2|3.7|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|||3.7|-4.2|
71789257|NCT00867009|143076349|SUPERIORITY_OR_OTHER||Percentage of participants with response|38.5|||||TWO_SIDED|80.0|32.3|45.09||||||||45.09|32.30|
71789258|NCT00867009|143076350|SUPERIORITY_OR_OTHER||Median number of months|5.82|||||TWO_SIDED|80.0|4.4|6.7||||||||6.70|4.40|
71789259|NCT00867009|143076351|SUPERIORITY_OR_OTHER||Percentage of participants with response|45.0|||||TWO_SIDED|80.0|39.0|51.0||||||||51|39|
71789260|NCT00867009|143076352|SUPERIORITY_OR_OTHER||Percentage of participants with response|59.6|||||TWO_SIDED|80.0|53.06|65.94||||||||65.94|53.06|
71837792|NCT02515773|143182704|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
71837793|NCT02515773|143182705|SUPERIORITY||Mean Difference (Net)|0.07||||0.044|TWO_SIDED||||||ANCOVA|||||||0.044
71837794|NCT02515773|143182706|SUPERIORITY||Mean Difference (Net)|0.08|||<|0.001|TWO_SIDED|||||This is a calculated p-value less than 0.001|ANCOVA|||||||<0.001
71837795|NCT02515773|143182707|SUPERIORITY||Mean Difference (Net)|0.09||||0.041|TWO_SIDED||||||ANCOVA|||||||0.041
71837796|NCT04176965|143182716|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in means between the 2 groups (FINEVISION HP - AcrySof SN60AT). Non-inferiority margin = 0.10 logMAR.|Mean difference|0.045|STANDARD_ERROR_OF_MEAN|0.0084|<|0.0001|TWO_SIDED|90.0|0.0316|0.0592|||t-test, 1 sided|||||0.0592|0.0316|<0.0001
71837797|NCT04176965|143182717|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71837798|NCT04176965|143182718|NON_INFERIORITY|Noninferiority of FINEVISION HP compared to control in percentages of first operative eyes with secondary surgical interventions related to the optical properties of the IOL was evaluated using two-sided 90% Farrington method confidence intervals around the difference in percentages between the 2 groups. If the upper limit of the confidence interval is less than 1.4%, the FINEVISION HP IOL will be considered statistically non-inferior to the control IOL.|Difference in percentages|0.3|||||TWO_SIDED|90.0|-0.76|1.36||||||||1.36|-0.76|
71756956|NCT01409707|143017506|SUPERIORITY_OR_OTHER||||||=|0.068||95.0||||The a priori threshold for statistical significance was set at p = .05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.||||=.068
71756957|NCT01409707|143017507|SUPERIORITY_OR_OTHER||||||=|0.39||95.0||||The a priori threshold for statistical significance was set at p=.05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.||||= 0.39
71756958|NCT05366738|143017576|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.36|||||TWO_SIDED|90.0|97.64|109.41||||||||109.41|97.64|
71756959|NCT05366738|143017576|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.83|||||TWO_SIDED|90.0|92.42|103.56||||||||103.56|92.42|
71756960|NCT05366738|143017577|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|102.56|||||TWO_SIDED|90.0|97.25|108.15||||||||108.15|97.25|
71671622|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
71671623|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|0|
71677198|NCT04143594|142873006|SUPERIORITY||Difference in percentage|-7.1||||0.3686|TWO_SIDED|95.0|-23.2|9.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||9.0|-23.2|0.3686
71756961|NCT05366738|143017577|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|97.61|||||TWO_SIDED|90.0|92.55|102.93||||||||102.93|92.55|
71756962|NCT05366738|143017578|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|103.96|||||TWO_SIDED|90.0|96.49|112.0||||||||112.00|96.49|
71756963|NCT05366738|143017578|EQUIVALENCE|Bioequivalence was concluded if the 90% confidence interval for the geometric mean ratio between the test treatments (20 mg sprinkle capsule, either sprinkled on pudding or on applesauce) and the reference treatment (20 mg tablet) were wholly contained within 80.00% and 125.00% for the vonoprazan PK parameters.|Ratio of Geometric Least Square Means|100.6|||||TWO_SIDED|90.0|93.38|108.39||||||||108.39|93.38|
71756964|NCT03038100|143017613|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2785|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2785
71756965|NCT03038100|143017614|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0376|TWO_SIDED|95.0|0.65|0.99|||Log Rank|||||0.99|0.65|0.0376
71756966|NCT03038100|143017615|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3432|TWO_SIDED|95.0|0.78|1.09|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2), tumor PD-L1 status (IC0 vs. IC1/2/3), and treatment strategy (adjuvant vs. neoadjuvant).||1.09|0.78|0.3432
71756967|NCT03038100|143017616|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.83||||0.1316|TWO_SIDED|95.0|0.66|1.06|||Log Rank|||Stratified by: stage and/or surgical status (Stage III vs. Stage IV), ECOG performance status (0 vs. 1 or 2) and treatment strategy (adjuvant vs. neoadjuvant).||1.06|0.66|0.1316
71756968|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.9096|TWO_SIDED|95.0|0.58|1.62|||Cochran-Mantel-Haenszel|||Emotional Functioning, Presurgical/Surgery||1.62|0.58|0.9096
71756969|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.4662|TWO_SIDED|95.0|0.73|2.01|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 4 Day 1||2.01|0.73|0.4662
71756970|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.5237|TWO_SIDED|95.0|0.51|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 6 Day 1||1.40|0.51|0.5237
71756971|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.25||||0.3826|TWO_SIDED|95.0|0.76|2.07|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||2.07|0.76|0.3826
71756972|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.56|1.76|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.76|0.56|0.9893
71756973|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.6892|TWO_SIDED|95.0|0.49|1.61|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.61|0.49|0.6892
71756974|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.1324|TWO_SIDED|95.0|0.3|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.17|0.30|0.1324
71756975|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.9176|TWO_SIDED|95.0|0.62|1.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/Early Termination Visit||1.70|0.62|0.9176
71756976|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7861|TWO_SIDED|95.0|0.5|1.68|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.68|0.50|0.7861
71756977|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.31||||0.4539|TWO_SIDED|95.0|0.65|2.65|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||2.65|0.65|0.4539
71756978|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.71||||0.4849|TWO_SIDED|95.0|0.27|1.86|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.86|0.27|0.4849
71756979|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.747|TWO_SIDED|95.0|0.19|3.34|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||3.34|0.19|0.7470
71756980|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.0896|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.0896
71837799|NCT04176965|143182723|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71789261|NCT00147199|143076366|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate|20.0||||0.00044|TWO_SIDED|95.0|8.0|32.8|||ANCOVA|Lowest rank was assigned for death, discontinuation due to disease progression, and for patients who initiated additional approved PAH therapy.||Sample size was calculated based on the primary endpoint; change in 6MWD at Week 12. Assuming a between-treatment difference of 35m, a standard deviation of 75m, and a type I (alpha) error of 0.05 (i.e., two-sided p-value of less than 0.05), in order to have 90% power to detect this difference, 100 subjects per treatment group were required for this trial (total n=200). This allowed for a dropout rate of 10% as 110 subjects per group was planned.||32.8|8.0|0.00044
71789262|NCT00147199|143076368|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.623|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank sum test|||||0.0|-0.5|0.623
71789263|NCT00147199|143076369|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.807|TWO_SIDED|95.0|0.0|0.0||Imputation strategies were implemented for 16 inhaled treprostinil subjects and 9 placebo subjects without values reported at Week 12|Wilcoxon rank sum test|||||0.0|0.0|0.807
71789264|NCT00147199|143076370|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.7||||0.007|TWO_SIDED|95.0|4.0|24.8|||ANCOVA|||||24.8|4.0|0.007
71789265|NCT00147199|143076371|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|18.5||||0.0003|TWO_SIDED|95.0|8.5|28.3|||Wilcoxon rank sum test|||||28.3|8.5|0.0003
71789266|NCT00147199|143076372|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-4.0||||0.027|TWO_SIDED|95.0|-8.0|0.0|||Wilcoxon rank sum test|||Global Score||0|-8.0|0.027
71789267|NCT00147199|143076372|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-2.0||||0.037|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon rank sum test|||Physical Dimension||0.0|-3.0|0.037
71789268|NCT00147199|143076372|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-1.0||||0.173|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon rank sum test|||Emotional Dimension Score||0.0|-2.0|0.173
71789269|NCT00147199|143076374|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman Estimate|-167.0||||0.001|TWO_SIDED|95.0|-333.0|-64.0|||Wilcoxon rank sum test|||||-64|-333|0.001
71789270|NCT01850524|143076375|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.073|TWO_SIDED|95.0|0.676|1.018|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.||||1.018|0.676|0.073
71789271|NCT01850524|143076376|SUPERIORITY||Hazard Ratio (HR)|0.998||||0.988|TWO_SIDED|95.0|0.79|1.261|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an Unadjusted Cox's proportional hazard regression model is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.261|0.790|0.988
71789272|NCT01850524|143076377|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.43|3.09|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||3.09|1.43|<0.001
71789273|NCT01850524|143076378|SUPERIORITY||Odds Ratio (OR)|0.98||||0.9195|TWO_SIDED|95.0|0.656|1.463|||Regression, Logistic|Logistic regression model with prognostic factor: age (\<75 years vs \>=75) and ISS (stage I or II vs stage III).|Odds ratio \> 1 favors Ixazomib+LenDex versus LenDex alone.|||1.463|0.656|0.9195
71789274|NCT01850524|143076379|SUPERIORITY||Odds Ratio (OR)|1.16||||0.436|TWO_SIDED|95.0|0.79|1.7|||Cochran-Mantel-Haenszel|CMH test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Odds ratio and confidence interval are based on logistic regression model with treatment group as categorical predictor variable,age(\<75 years vs \>=75), ISS(stage I or II vs stage III),and BPI-SF worst pain score(\<4 vs \>=4)at screening as covariates.|||1.70|0.79|0.436
71789275|NCT01850524|143076380|SUPERIORITY||Hazard Ratio (HR)|1.402|||<|0.001|TWO_SIDED|95.0|1.185|1.659|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.659|1.185|<0.001
71789276|NCT01850524|143076382|SUPERIORITY||Hazard Ratio (HR)|0.738||||0.008|TWO_SIDED|95.0|0.589|0.925|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||0.925|0.589|0.008
71789277|NCT01850524|143076383|SUPERIORITY||Hazard Ratio (HR)|0.859||||0.189|TWO_SIDED|95.0|0.684|1.078|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|||1.078|0.684|0.189
71837800|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837801|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Cystoid macular oedema. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837802|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837803|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Hypopyon. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71671624|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-1.0|10.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||10|-1|
71671625|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||5|-6|
71671626|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||0|-13|
71671627|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|-3.0|11.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||11|-3|
71756981|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Emotional Functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
71756982|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.7347|TWO_SIDED|95.0|0.56|1.5|||Cochran-Mantel-Haenszel|||Physical Functioning, Presurgical/Surgery||1.50|0.56|0.7347
71837804|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837805|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Endophthalmitis. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71756983|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.56||||0.0479|TWO_SIDED|95.0|0.32|1.0|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 4 Day 1||1.00|0.32|0.0479
71756984|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.61||||0.0712|TWO_SIDED|95.0|0.36|1.05|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 6 Day 1||1.05|0.36|0.0712
71756985|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8168|TWO_SIDED|95.0|0.56|1.58|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 8 Day 1||1.58|0.56|0.8168
71756986|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.6417|TWO_SIDED|95.0|0.5|1.52|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 12 Day 1||1.52|0.50|0.6417
71756987|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8821|TWO_SIDED|95.0|0.53|1.72|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 16 Day 1||1.72|0.53|0.8821
71756988|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.2158|TWO_SIDED|95.0|0.32|1.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Cycle 20 Day 1||1.30|0.32|0.2158
71756989|NCT03038100|143017622|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4762|TWO_SIDED|95.0|0.51|1.37|||Cochran-Mantel-Haenszel|||Physical Functioning, Completion of Treatment/Early Termination Visit||1.37|0.51|0.4762
71756990|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.7585|TWO_SIDED|95.0|0.61|1.96|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 3 Months||1.96|0.61|0.7585
71756991|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9985|TWO_SIDED|95.0|0.52|1.93|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 6 Months||1.93|0.52|0.9985
71756992|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.07||||0.1067|TWO_SIDED|95.0|0.85|5.06|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 9 Months||5.06|0.85|0.1067
71756993|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.42||||0.6171|TWO_SIDED|95.0|0.36|5.61|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 12 Months||5.61|0.36|0.6171
71756994|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 18 Months||23.57|0.08|0.8084
71756995|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-50.0||||0.3173|TWO_SIDED|95.0|-100.0|94.3|||Cochran-Mantel-Haenszel|||Physical Functioning, Post-Treatment Follow Up 24 Months||94.30|-100.00|0.3173
71756996|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6802|TWO_SIDED|95.0|0.69|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Presurgical/Surgery||1.77|0.69|0.6802
71756997|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.347|TWO_SIDED|95.0|0.48|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 4 Day 1||1.29|0.48|0.3470
71756998|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.5564|TWO_SIDED|95.0|0.53|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 6 Day 1||1.41|0.53|0.5564
71756999|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.5|TWO_SIDED|95.0|0.72|1.99|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.99|0.72|0.5000
71757000|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9778|TWO_SIDED|95.0|0.57|1.78|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.78|0.57|0.9778
71757001|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6005|TWO_SIDED|95.0|0.65|2.12|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||2.12|0.65|0.6005
71757002|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.5|2.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||2.00|0.50|0.9900
71757003|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.32||||0.2634|TWO_SIDED|95.0|0.81|2.15|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/Early Termination Visit||2.15|0.81|0.2634
71757004|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.964|TWO_SIDED|95.0|0.56|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.56|0.9640
71757005|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.76||||0.4117|TWO_SIDED|95.0|0.4|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.46|0.40|0.4117
71757006|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.3505|TWO_SIDED|95.0|0.63|3.62|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||3.62|0.63|0.3505
71677199|NCT04143594|142873006|SUPERIORITY||Difference in percentage|-16.5||||0.0887|TWO_SIDED|95.0|-34.0|1.0||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||1.0|-34.0|0.0887
71757007|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.28||||0.2439|TWO_SIDED|95.0|0.55|9.45|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||9.45|0.55|0.2439
71757008|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33||||0.1573|TWO_SIDED|95.0|-44.86|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||100.00|-44.86|0.1573
71757009|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-94.30|
71757010|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.182|TWO_SIDED|95.0|0.45|1.16|||Cochran-Mantel-Haenszel|||Role Functioning, Presurgical/Surgery||1.16|0.45|0.1820
71757011|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.47||||0.0046|TWO_SIDED|95.0|0.28|0.8|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 4 Day 1||0.80|0.28|0.0046
71757012|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.59||||0.0361|TWO_SIDED|95.0|0.36|0.97|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 6 Day 1||0.97|0.36|0.0361
71757013|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.0848|TWO_SIDED|95.0|0.39|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.06|0.39|0.0848
71757014|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1224|TWO_SIDED|95.0|0.37|1.13|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.13|0.37|0.1224
71757015|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.3127|TWO_SIDED|95.0|0.41|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.33|0.41|0.3127
71757016|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.6065|TWO_SIDED|95.0|0.42|1.65|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.65|0.42|0.6065
71757017|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2173|TWO_SIDED|95.0|0.45|1.2|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.20|0.45|0.2173
71757018|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.64||||0.1316|TWO_SIDED|95.0|0.35|1.15|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.15|0.35|0.1316
71757019|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.7678|TWO_SIDED|95.0|0.46|1.76|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.76|0.46|0.7678
71757020|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.7331|TWO_SIDED|95.0|0.34|2.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||2.14|0.34|0.7331
71757021|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.83||||0.1235|TWO_SIDED|95.0|0.73|10.92|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||10.92|0.73|0.1235
71757022|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|0.0|||||TWO_SIDED|95.0|-84.09|84.09||||||Role functioning, Post-Treatment Follow Up 18 Months||84.09|-84.09|
71757023|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
71757024|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7869|TWO_SIDED|95.0|0.65|1.78|||Cochran-Mantel-Haenszel|||Social functioning, Presurgical/Surgery||1.78|0.65|0.7869
71757025|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.2502|TWO_SIDED|95.0|0.43|1.25|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 4 Day 1||1.25|0.43|0.2502
71671628|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|10.0|||||TWO_SIDED|95.0|4.0|17.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||17|4|
71757026|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.5066|TWO_SIDED|95.0|0.5|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 6 Day 1||1.41|0.50|0.5066
71757027|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.8124|TWO_SIDED|95.0|0.56|1.59|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.59|0.56|0.8124
71757028|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.4656|TWO_SIDED|95.0|0.7|2.17|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||2.17|0.70|0.4656
71757029|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6725|TWO_SIDED|95.0|0.62|2.12|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||2.12|0.62|0.6725
71837806|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71757030|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.578|TWO_SIDED|95.0|0.41|1.64|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.64|0.41|0.5780
71757031|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7611|TWO_SIDED|95.0|0.66|1.76|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/Early Termination Visit||1.76|0.66|0.7611
71757032|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.7588|TWO_SIDED|95.0|0.62|1.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.94|0.62|0.7588
71757033|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.1428|TWO_SIDED|95.0|0.3|1.19|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.19|0.30|0.1428
71757034|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9802|TWO_SIDED|95.0|0.41|2.39|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||2.39|0.41|0.9802
71757035|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.34||||0.1967|TWO_SIDED|95.0|0.63|8.7|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||8.70|0.63|0.1967
71757036|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Respnders|8.33||||0.4795|TWO_SIDED|95.0|-69.28|85.94|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||85.94|-69.28|0.4795
71757037|NCT03038100|143017622|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0|||||TWO_SIDED|95.0|-94.3|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-94.30|
71757038|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6651|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.25|0.70|0.6651
71757039|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9927|TWO_SIDED|95.0|0.75|1.34|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.34|0.75|0.9927
71757040|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.03||||0.8209|TWO_SIDED|95.0|0.77|1.39|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.39|0.77|0.8209
71757041|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.6507|TWO_SIDED|95.0|0.79|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.45|0.79|0.6507
71757042|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.21||||0.2596|TWO_SIDED|95.0|0.87|1.67|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.67|0.87|0.2596
71837807|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Lens dislocated from posterior chamber. The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837808|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837809|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Pupillary block.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837810|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837811|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Retinal detachment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71757043|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.6532|TWO_SIDED|95.0|0.75|1.58|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.58|0.75|0.6532
71757044|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7592|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion Of Treatment/ Early Termination Visit||1.45|0.76|0.7592
71757045|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.7424|TWO_SIDED|95.0|0.62|1.4|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.40|0.62|0.7424
71671629|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-13.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-13|
71671630|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-6.0|8.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||8|-6|
71837812|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71757046|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.1912|TWO_SIDED|95.0|0.85|2.19|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||2.19|0.85|0.1912
71757047|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.5526|TWO_SIDED|95.0|0.45|1.53|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||1.53|0.45|0.5526
71757048|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.3609|TWO_SIDED|95.0|0.32|1.52|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||1.52|0.32|0.3609
71757049|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7527|TWO_SIDED|95.0|0.2|3.23|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||3.23|0.20|0.7527
71757050|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Emotional functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
71757051|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.3177|TWO_SIDED|95.0|0.62|1.17|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.17|0.62|0.3177
71757052|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4184|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.21|0.63|0.4184
71757053|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.571|TWO_SIDED|95.0|0.67|1.24|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.24|0.67|0.5710
71757054|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3973|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.19|0.65|0.3973
71789278|NCT01850524|143076389|SUPERIORITY||Hazard Ratio (HR)|1.118||||0.662|TWO_SIDED|95.0|0.678|1.845|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|OS in High-risk Population Carrying Del(17p), Amp(1q21), t(4;14), or t(14;16) Mutations||1.845|0.678|0.662
71837813|NCT04176965|143182724|NON_INFERIORITY|Cumulative: Secondary surgical intervention.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837814|NCT04176965|143182724|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837815|NCT04176965|143182724|NON_INFERIORITY|Persistent: Corneal stroma oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71757055|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.5163|TWO_SIDED|95.0|0.8|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.55|0.80|0.5163
71757056|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6897|TWO_SIDED|95.0|0.64|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.35|0.64|0.6897
71757057|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.5735|TWO_SIDED|95.0|0.67|1.25|||Cochran-Mantel-Haenszel|||Physical functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.67|0.5735
71757058|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.75||||0.1414|TWO_SIDED|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.10|0.50|0.1414
71757059|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8655|TWO_SIDED|95.0|0.59|1.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.55|0.59|0.8655
71757060|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.72||||0.3017|TWO_SIDED|95.0|0.38|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.35|0.38|0.3017
71757061|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.6||||0.2325|TWO_SIDED|95.0|0.26|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||1.39|0.26|0.2325
71757062|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.33||||0.1717|TWO_SIDED|95.0|0.06|1.69|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||1.69|0.06|0.1717
71837816|NCT04176965|143182724|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71757063|NCT03038100|143017623|SUPERIORITY|Stratified Analsyis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Physical functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
71837817|NCT04176965|143182724|NON_INFERIORITY|Persistent: Cystoid macular oedema.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837818|NCT04176965|143182724|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837819|NCT04176965|143182724|NON_INFERIORITY|Persistent: Iritis.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837820|NCT04176965|143182724|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the FINEVISION HP group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837821|NCT04176965|143182724|NON_INFERIORITY|Persistent: Raised Intraocular Pressure (IOP) requiring treatment.The observed AE rates in the control group were compared to the SPE rates from ISO 11979-7 Table E.2. A p value of \>0.05 indicates that the rates were statistically not significant when compared to SPE rates.|||||>|0.05|||||||One-sided exact binomial test|||||||>0.05
71837822|NCT03033576|143182732|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.04|TWO_SIDED|90.0|0.41|0.97||Pre-specified one-sided alpha=0.1|Log Rank|||The statistical design assumed exponential PFS with a median of 3.0 months on the ipilimumab group (null hypothesis). The study was powered to detect a change in median PFS to 6.0 months in the combination therapy group (corresponding to an HR of 0.50). A total of 84 participants (63 randomized to combination group and 21 to ipilimumab group) with 78 events (across both groups) would provide 89% power for a one-sided alpha of 10% using a log-rank test.||0.97|0.41|0.04
71837823|NCT03033576|143182735|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.28|TWO_SIDED|90.0|0.5|1.39|||Log Rank|||||1.39|0.50|0.28
71837824|NCT05026320|143182863|EQUIVALENCE|The primary efficacy hypothesis to be tested was the equality of tenderness (algometry) over the initial 72 hours (algometry AUC 0-72).||||||0.0221|||||||ANCOVA|||||||0.0221
71757064|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4745|TWO_SIDED|95.0|0.84|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.46|0.84|0.4745
71757065|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5499|TWO_SIDED|95.0|0.69|1.22|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.22|0.69|0.5499
71757066|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8436|TWO_SIDED|95.0|0.73|1.29|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 8 Day 1||1.29|0.73|0.8436
71757067|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5798|TWO_SIDED|95.0|0.81|1.46|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.46|0.81|0.5798
71837825|NCT05478499|143182866|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.3|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||15.3|2.5|<0.0001
71837826|NCT05478499|143182866|SUPERIORITY||Odds Ratio (OR)|7.0|||<|0.0001|TWO_SIDED|95.0|2.7|18.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||18.4|2.7|<0.0001
71837827|NCT05478499|143182867|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.0001||95.0|4.6|352.0|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Full Analysis Set||352.0|4.6|<0.0001
71837828|NCT05478499|143182867|SUPERIORITY||Odds Ratio (OR)|37.3|||<|0.0001|TWO_SIDED|95.0|4.4|317.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|Patient sub-population (s-PGA ≥ 3)||317.6|4.4|<0.0001
71757068|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9094|TWO_SIDED|95.0|0.74|1.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.39|0.74|0.9094
71757069|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.4006|TWO_SIDED|95.0|0.81|1.67|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||1.67|0.81|0.4006
71757070|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4024|TWO_SIDED|95.0|0.65|1.19|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.19|0.65|0.4024
71757071|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8796|TWO_SIDED|95.0|0.67|1.41|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.41|0.67|0.8796
71837829|NCT05478499|143182868|SUPERIORITY||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.3|-1.6|||analysis of covariance model||analysis of covariance model|Full Analysis Set||-1.6|-3.3|<0.0001
71837830|NCT05478499|143182868|SUPERIORITY||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.3|-1.5|||analysis of covariance model||analysis of covariance model|Patient sub-population (s-PGA ≥ 3)||-1.5|-3.3|<0.0001
71837831|NCT05478499|143182869|SUPERIORITY||Odds Ratio (OR)|23.9|||<|0.0001|TWO_SIDED|95.0|5.4|105.6|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel|||105.6|5.4|<0.0001
71837832|NCT02962895|143182875|SUPERIORITY||Least Squares Mean Difference|0.75||||0.5161|TWO_SIDED|95.0|-1.52|3.02|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.02|-1.52|0.5161
71757072|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.435|TWO_SIDED|95.0|0.53|1.32|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.32|0.53|0.4350
71757073|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.6225|TWO_SIDED|95.0|0.47|1.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 9 Months||1.56|0.47|0.6225
71757074|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.5775|TWO_SIDED|95.0|0.36|1.77|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||1.77|0.36|0.5775
71789279|NCT01850524|143076390|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.271|TWO_SIDED|95.0|0.466|1.24|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations||1.240|0.466|0.271
71789280|NCT01850524|143076392|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.26|TWO_SIDED|95.0|0.661|1.12|||Log Rank|Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.|Time to Pain Progression||1.120|0.661|0.260
71789281|NCT00556712|143076445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.62|0.82|||Log Rank|||||0.82|0.62|<0.0001
71789282|NCT00556712|143076449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0097|TWO_SIDED|95.0|0.72|0.96|||Log Rank|||||0.96|0.72|0.0097
71789283|NCT00556712|143076452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.005|TWO_SIDED|95.0|0.66|0.93|||Log Rank|||||0.93|0.66|0.0050
71789284|NCT00556712|143076455|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.1768|TWO_SIDED|95.0|0.51|1.14|||Log Rank|||||1.14|0.51|0.1768
71789285|NCT00556712|143076458|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4797|TWO_SIDED|95.0|0.49|1.4|||Log Rank|||||1.40|0.49|0.4797
71789286|NCT00556712|143076460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.82|||Log Rank|||||0.82|0.61|<0.0001
71789287|NCT00556712|143076462|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.53||||0.0006|TWO_SIDED|95.0|2.7|10.3|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||10.3|2.7|0.0006
71837833|NCT02962895|143182875|SUPERIORITY||Least Squares Mean Difference|-0.55||||0.6332|TWO_SIDED|95.0|-2.8|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.71|-2.80|0.6332
71837834|NCT02962895|143182875|SUPERIORITY||Least Squares Mean Difference|-1.92||||0.0921|TWO_SIDED|95.0|-4.15|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.32|-4.15|0.0921
71837835|NCT02962895|143182877|SUPERIORITY||Least Squares Mean Difference|0.32||||0.4457|TWO_SIDED|95.0|-0.5|1.13|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||1.13|-0.50|0.4457
71789288|NCT00556712|143076464|SUPERIORITY_OR_OTHER||Difference in Response Upgrade Rates|4.2||||0.0007|TWO_SIDED|95.0|1.6|6.7|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|||6.7|1.6|0.0007
71837836|NCT02962895|143182877|SUPERIORITY||Least Square Mean Difference|0.01||||0.301|TWO_SIDED|95.0|-0.79|0.82|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||0.82|-0.79|0.301
71837837|NCT02962895|143182877|SUPERIORITY||Least Square Mean Difference|-0.06||||0.8858|TWO_SIDED|95.0|-0.86|0.74|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||0.74|-0.86|0.8858
71837838|NCT02962895|143182879|SUPERIORITY||Least Squares Mean Difference|-1.93||||0.3424|TWO_SIDED|95.0|-5.93|2.07|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||2.07|-5.93|0.3424
71892431|NCT01381094|143306462|SUPERIORITY||||||=|0.9916|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.9916
71892432|NCT01381094|143306462|SUPERIORITY||||||=|0.2292|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.2292
71837839|NCT02962895|143182879|SUPERIORITY||Least Squares Mean Difference|-2.56||||0.2092|TWO_SIDED|95.0|-6.58|1.45|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||1.45|-6.58|0.2092
71789289|NCT00556712|143076466|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|9.8||||0.0035|TWO_SIDED|95.0|3.1|16.4|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD rate.||16.4|3.1|0.0035
71789290|NCT00556712|143076466|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|13.4|||<|0.0001|TWO_SIDED|95.0|7.1|19.7|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD \> 12 weeks rate.||19.7|7.1|<0.0001
71789291|NCT00556712|143076468|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.3787|TWO_SIDED|95.0|0.74|1.12|||Log Rank|||||1.12|0.74|0.3787
71789292|NCT00556712|143076470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|< 0.0001
71837840|NCT02962895|143182879|SUPERIORITY||Least Squares Mean Difference|0.31||||0.874|TWO_SIDED|95.0|-3.58|4.2|||Mixed Models Analysis|Confidence intervals and p-values are derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.20|-3.58|0.8740
71892433|NCT01381094|143306462|SUPERIORITY||||||=|0.1331|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1331
71757075|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.37||||0.2343|TWO_SIDED|95.0|0.07|1.94|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||1.94|0.07|0.2343
71837841|NCT02962895|143182881|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.5768|TWO_SIDED|95.0|-4.61|2.57|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Mental Component Score||2.57|-4.61|0.5768
71837842|NCT02962895|143182881|SUPERIORITY||Least Squares Mean Difference|0.68||||0.7113|TWO_SIDED|95.0|-2.93|4.28|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Mental Component Score||4.28|-2.93|0.7113
71837843|NCT02962895|143182881|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5722|TWO_SIDED|95.0|-2.49|4.48|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Mental Component Score||4.48|-2.49|0.5722
71837844|NCT02962895|143182881|SUPERIORITY||Least Squares Mean Difference|1.84||||0.4138|TWO_SIDED|95.0|-1.59|3.83|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo / Physical Component Score||3.83|-1.59|0.4138
71837845|NCT02962895|143182881|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.4663|TWO_SIDED|95.0|-3.72|1.71|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo / Physical Component Score||1.71|-3.72|0.4663
71837846|NCT02962895|143182881|SUPERIORITY||Least Squares Mean Difference|1.84||||0.1694|TWO_SIDED|95.0|-0.79|4.47|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo / Physical Component Score||4.47|-0.79|0.1694
71757076|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-66.67||||0.0833|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.0833
71757077|NCT03038100|143017623|SUPERIORITY|Superiority|Odds Ratio (OR)|0.93||||0.6012|TWO_SIDED|95.0|0.71|1.21|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.21|0.71|0.6012
71757078|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.2291|TWO_SIDED|95.0|0.65|1.11|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.11|0.65|0.2291
71837847|NCT02962895|143182883|SUPERIORITY||Least Squares Mean Difference|-4.17||||0.2671|TWO_SIDED|95.0|-11.56|3.22|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||3.22|-11.56|0.2671
71837848|NCT02962895|143182883|SUPERIORITY||Least Squares Mean Difference|-4.49||||0.2248|TWO_SIDED|95.0|-11.78|2.79|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||2.79|-11.78|0.2248
71837849|NCT02962895|143182883|SUPERIORITY||Least Squares Mean Difference|-8.36||||0.0224|TWO_SIDED|95.0|-15.51|-1.2|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||-1.20|-15.51|0.0224
71837850|NCT02962895|143182885|SUPERIORITY||Least Squares Mean Difference|2.27||||0.6457|TWO_SIDED|95.0|-7.46|12.0|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo||12.00|-7.46|0.6457
71837851|NCT02962895|143182885|SUPERIORITY||Least Squares Mean Difference|3.26||||0.5132|TWO_SIDED|95.0|-6.55|13.06|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo||13.06|-6.55|0.5132
71837852|NCT02962895|143182885|SUPERIORITY||Least Squares Mean Difference|-4.77||||95|TWO_SIDED|95.0|-14.21|4.68|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo||4.68|-14.21|95
71837853|NCT02962895|143182886|SUPERIORITY||Least Squares Mean Difference|0.11||||0.271|TWO_SIDED|95.0|-0.08|0.3|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Stimulated salivary flow rate)||0.30|-0.08|0.2710
71837854|NCT02962895|143182886|SUPERIORITY||Least Squares Mean Difference|0.13||||0.1618|TWO_SIDED|95.0|-0.05|0.32|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Stimulated salivary flow rate)||0.32|-0.05|0.1618
71757079|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6574|TWO_SIDED|95.0|0.71|1.24|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.24|0.71|0.6574
71757080|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9217|TWO_SIDED|95.0|0.76|1.35|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.35|0.76|0.9217
71837855|NCT02962895|143182886|SUPERIORITY||Least Squares Mean Difference|0.2||||0.0374|TWO_SIDED|95.0|0.01|0.38|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Stimulated salivary flow rate)||0.38|0.01|0.0374
71757081|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7693|TWO_SIDED|95.0|0.7|1.3|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.30|0.70|0.7693
71757082|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.647|TWO_SIDED|95.0|0.64|1.31|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.31|0.64|0.6470
71757083|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.6391|TWO_SIDED|95.0|0.7|1.25|||Cochran-Mantel-Haenszel|||Role functioning, Completion Of Treatment/ Early Termination Visit||1.25|0.70|0.6391
71837856|NCT02962895|143182886|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9559|TWO_SIDED|95.0|-0.09|0.09|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 5 mg vs. Placebo (Unstimulated salivary flow rate)||0.09|-0.09|0.9559
71757084|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.0892|TWO_SIDED|95.0|0.51|1.05|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.05|0.51|0.0892
71757085|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.055|TWO_SIDED|95.0|0.41|1.01|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||1.01|0.41|0.0550
71757086|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.49||||0.0168|TWO_SIDED|95.0|0.27|0.88|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||0.88|0.27|0.0168
71757087|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.29||||0.0021|TWO_SIDED|95.0|0.13|0.65|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||0.65|0.13|0.0021
71757088|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.7817|TWO_SIDED|95.0|0.17|3.8|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||3.80|0.17|0.7817
71757089|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|-33.33|||||TWO_SIDED|95.0|-100.0|75.44||||||Role functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|
71757090|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.6646|TWO_SIDED|95.0|0.8|1.41|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.41|0.80|0.6646
71757091|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8677|TWO_SIDED|95.0|0.73|1.3|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.30|0.73|0.8677
71757092|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.767|TWO_SIDED|95.0|0.79|1.38|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.38|0.79|0.7670
71757093|NCT03038100|143017623|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7487|TWO_SIDED|95.0|0.71|1.28|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.28|0.71|0.7487
71757094|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.23||||0.1882|TWO_SIDED|95.0|0.9|1.68|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.68|0.90|0.1882
71757095|NCT03038100|143017623|SUPERIORITY||Odds Ratio (OR)|1.21||||0.3015|TWO_SIDED|95.0|0.84|1.72|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.72|0.84|0.3015
71757096|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.9059|TWO_SIDED|95.0|0.73|1.32|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.32|0.73|0.9059
71757097|NCT03038100|143017623|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7125|TWO_SIDED|95.0|0.65|1.35|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.35|0.65|0.7125
71757098|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.68||||0.0947|TWO_SIDED|95.0|0.43|1.07|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||1.07|0.43|0.0947
71789293|NCT00556712|143076473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5385|TWO_SIDED|95.0|0.87|1.31|||Log Rank|||||1.31|0.87|0.5385
71789294|NCT00556712|143076476|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.653|TWO_SIDED|95.0|0.79|1.16|||Log Rank|||||1.16|0.79|0.6530
71789295|NCT00501293|143076490|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.028
71757099|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.58||||0.0686|TWO_SIDED|95.0|0.32|1.05|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||1.05|0.32|0.0686
71757100|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.39||||0.0175|TWO_SIDED|95.0|0.17|0.86|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||0.86|0.17|0.0175
71757101|NCT03038100|143017623|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.46||||0.3376|TWO_SIDED|95.0|0.09|2.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||2.30|0.09|0.3376
71757102|NCT03038100|143017623|SUPERIORITY||Difference in Proportion of Responders|-50.0||||0.5637|TWO_SIDED|95.0|-100.0|23.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 24 Months||23.34|-100.00|0.5637
71757103|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.977|TWO_SIDED|95.0|0.76|1.3|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 3 Day 1||1.30|0.76|0.9770
71757104|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7317|TWO_SIDED|95.0|0.8|1.37|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 5 Day 1||1.37|0.80|0.7317
71757105|NCT03038100|143017624|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6937|TWO_SIDED|95.0|0.8|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 8 Day 1||1.39|0.80|0.6937
71757106|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.3916|TWO_SIDED|95.0|0.66|1.18|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 12 Day 1||1.18|0.66|0.3916
71757107|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.3363|TWO_SIDED|95.0|0.63|1.17|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 16 Day 1||1.17|0.63|0.3363
71757108|NCT03038100|143017624|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6761|TWO_SIDED|95.0|0.75|1.55|||Cochran-Mantel-Haenszel|||Emotional Functioning, Cycle 20 Day 1||1.55|0.75|0.6761
71757109|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6997|TWO_SIDED|95.0|0.71|1.26|||Cochran-Mantel-Haenszel|||Emotional Functioning, Completion of Treatment/ Early Termination Visit||1.26|0.71|0.6997
71757110|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.19||||0.3592|TWO_SIDED|95.0|0.82|1.72|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 3 Months||1.72|0.82|0.3592
71789296|NCT00501293|143076490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
71789297|NCT00501293|143076491|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.027
71789298|NCT00501293|143076491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||<0.001
71789299|NCT00501293|143076494|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|t-test of MTS at baseline and 6 months||||||0.071
71789300|NCT00501293|143076494|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|t-test of placebo at baseline and 6 months||||||0.017
71789301|NCT03316131|143076544|OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|-8.67|9.22||||||||9.22|-8.67|
71789302|NCT03316131|143076545|OTHER||Geometric mean ratio|1.14|||||TWO_SIDED|90.0|1.03|1.25||||||Treatment A/Treatment B, for Verinurad||1.25|1.03|
71789303|NCT03316131|143076545|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.88|1.07||||||Treatment A/Treatment B, for M1||1.07|0.88|
71789304|NCT03316131|143076545|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08||||||Treatment A/Treatment B, for M8||1.08|0.91|
71789305|NCT03316131|143076546|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
71837857|NCT02962895|143182886|SUPERIORITY||Least Squares Mean Difference|0.0||||0.929|TWO_SIDED|95.0|-0.09|0.08|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 50 mg vs. Placebo (Unstimulated salivary flow rate)||0.08|-0.09|0.9290
71757111|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8798|TWO_SIDED|95.0|0.62|1.51|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 6 Months||1.51|0.62|0.8798
71757112|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.3857|TWO_SIDED|95.0|0.43|1.39|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 9 Months||1.39|0.43|0.3857
71789306|NCT03316131|143076546|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
71789307|NCT03316131|143076546|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
71789308|NCT03316131|143076550|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad||1.13|1.00|
71757113|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.85||||0.6854|TWO_SIDED|95.0|0.39|1.85|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 12 Months||1.85|0.39|0.6854
71757114|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.54||||0.4533|TWO_SIDED|95.0|0.11|2.7|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 18 Months||2.70|0.11|0.4533
71757115|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|-33.33||||0.3173|TWO_SIDED|95.0|-100.0|75.44|||Cochran-Mantel-Haenszel|||Emotional Functioning, Post-Treatment Follow Up 24 Months||75.44|-100.00|0.3173
71757116|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.13||||0.3658|TWO_SIDED|95.0|0.87|1.47|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.47|0.87|0.3658
71757117|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7619|TWO_SIDED|95.0|0.8|1.36|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.36|0.80|0.7619
71757118|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.658|TWO_SIDED|95.0|0.81|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.81|0.6580
71757119|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.18||||0.2726|TWO_SIDED|95.0|0.88|1.57|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.57|0.88|0.2726
71757120|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.6973|TWO_SIDED|95.0|0.69|1.29|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.29|0.69|0.6973
71789309|NCT03316131|143076550|OTHER||Geometric mean ratio|0.96||||||90.0|0.9|1.02||||||Treatment A/Treatment B, for M1||1.02|0.90|
71789310|NCT03316131|143076550|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8||1.04|0.94|
71789311|NCT02328755|143076563|OTHER|Single group|cumulative incidence|0.39|||||TWO_SIDED|95.0|0.24|0.58||||||The analysis applies only to the first row, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).||0.58|0.24|
71789312|NCT02328755|143076564|OTHER|Single group|Kaplan-Meier|55.0|||||TWO_SIDED|95.0|40.0|75.0||||||The analysis applies only to the first row, data at 6 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|75|40|
71789313|NCT02328755|143076564|OTHER|Single group|Kaplan-Meier|33.0|||||TWO_SIDED|95.0|19.0|58.0||||||The analysis applies only to the 3rd row, data at 24 months, for recipients of HLA-matched HCT who received the phase II MTD (180mcg) peg-IFN-a (n=31).|Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|58|19|
71837858|NCT02962895|143182886|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.7276|TWO_SIDED|95.0|-0.1|0.07|||Mixed Models Analysis|Confidence intervals and p-values derived from a mixed model for repeated measures (MMRM)||Week 24: VAY736 300 mg vs. Placebo (Unstimulated salivary flow rate)||0.07|-0.10|0.7276
71757121|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.447|TWO_SIDED|95.0|0.8|1.64|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.64|0.80|0.4470
71757122|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.515|TWO_SIDED|95.0|0.68|1.21|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.21|0.68|0.5150
71757123|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2103|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.82|0.88|0.2103
71757124|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.7969|TWO_SIDED|95.0|0.68|1.66|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.66|0.68|0.7969
71757125|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.6|1.91|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||1.91|0.60|0.8300
71757126|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.6987|TWO_SIDED|95.0|0.53|2.55|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||2.55|0.53|0.6987
71757127|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.32||||0.1441|TWO_SIDED|95.0|0.62|17.77|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||17.77|0.62|0.1441
71757128|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Difference in proportion of Responders|-66.67||||0.3173|TWO_SIDED|95.0|-100.0|4.39|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||4.39|-100.00|0.3173
71757129|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7591|TWO_SIDED|95.0|0.74|1.25|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 3 Day 1||1.25|0.74|0.7591
71757130|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.09||||0.5403|TWO_SIDED|95.0|0.83|1.42|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 5 Day 1||1.42|0.83|0.5403
71757131|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.2654|TWO_SIDED|95.0|0.89|1.55|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 8 Day 1||1.55|0.89|0.2654
71671631|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|7.0|||||TWO_SIDED|95.0|0.0|14.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||14|0|
71757132|NCT03038100|143017624|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5138|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 12 Day 1||1.48|0.82|0.5138
71757133|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.22||||0.2138|TWO_SIDED|95.0|0.89|1.67|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 16 Day 1||1.67|0.89|0.2138
71757134|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.26||||0.2114|TWO_SIDED|95.0|0.88|1.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Cycle 20 Day 1||1.82|0.88|0.2114
71789314|NCT02328755|143076565|OTHER|Single group|||||||||||||||||Survival proportion estimates at 6 months and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method.|||
71757135|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.3938|TWO_SIDED|95.0|0.85|1.53|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Completion of Treatment/ Early Termination Visit||1.53|0.85|0.3938
71757136|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7793|TWO_SIDED|95.0|0.65|1.38|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 3 Months||1.38|0.65|0.7793
71757137|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.737|TWO_SIDED|95.0|0.69|1.39|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 6 Months||1.39|0.69|0.7370
71757138|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9658|TWO_SIDED|95.0|0.55|1.79|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 9 Months||1.79|0.55|0.9658
71757139|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.3015|TWO_SIDED|95.0|0.29|1.46|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 12 Months||1.46|0.29|0.3015
71757140|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.77||||0.7534|TWO_SIDED|95.0|0.15|3.94|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 18 Months||3.94|0.15|0.7534
71757141|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Global health status/ QoL, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
71757142|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.8||||0.1177|TWO_SIDED|95.0|0.61|1.06|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.06|0.61|0.1177
71757143|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.17||||0.273|TWO_SIDED|95.0|0.88|1.56|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.56|0.88|0.2730
71757144|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9306|TWO_SIDED|95.0|0.73|1.33|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.33|0.73|0.9306
71789315|NCT02328755|143076566|OTHER|Single group|||||||||||||||||GVHD proportion estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
71677200|NCT04143594|142873006|SUPERIORITY||Difference in percentage|-5.4||||0.4949|TWO_SIDED|95.0|-21.5|10.7||P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (\<= 100,000 vs. \> 100,000 copies/mL).|Cochran-Mantel-Haenszel||The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs \> 100,000 copies/mL).|||10.7|-21.5|0.4949
71757145|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.97||||0.8631|TWO_SIDED|95.0|0.72|1.32|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.32|0.72|0.8631
71757146|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.0977|TWO_SIDED|95.0|0.95|1.86|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.86|0.95|0.0977
71757147|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.43||||0.0726|TWO_SIDED|95.0|0.97|2.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||2.10|0.97|0.0726
71757148|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9974|TWO_SIDED|95.0|0.73|1.38|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.38|0.73|0.9974
71789316|NCT02328755|143076567|OTHER|Single group|||||||||||||||||Non-relapse mortality estimates and corresponding 95% confidence intervals were calculated using methods of Fine and Gray.|||
71789317|NCT05022784|143076570|OTHER||||||<|0.0001|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compares the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||<.0001
71789318|NCT05022784|143076571|OTHER||||||<|0.0001|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||<.0001
71757149|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.7069|TWO_SIDED|95.0|0.72|1.63|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||1.63|0.72|0.7069
71757150|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.3||||0.3068|TWO_SIDED|95.0|0.78|2.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.16|0.78|0.3068
71757151|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.64||||0.1375|TWO_SIDED|95.0|0.85|3.16|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.16|0.85|0.1375
71757152|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.954|TWO_SIDED|95.0|0.46|2.29|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||2.29|0.46|0.9540
71837859|NCT03476460|143182900|NON_INFERIORITY|"We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable.~The non-inferiority of oral hydration would be shown if the upper limit of the 95% CI of the absolute risk difference between the groups was less than 5% (non-inferiority margin, indicated by the black dashed line)"|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-4.8|7.0|||||The 95% confidence interval for the difference between the two independent proportions was calculated according to Wilson's method.|Sample size was calculated to assess the non-inferiority of oral compared to intravenous hydration. We expected a primary outcome rate of 7% in the intravenous arm. We considered a priori a difference of no more than 5% in the incidence of CA-AKI in the oral compared to the intravenous arm (non-inferiority margin) to be acceptable. Thus, 266 participants, 133 per arm, were required to ensure at least 80% power at a significance level of α = 2.5% (one-sided).||7.0|-4.8|
71837860|NCT03476460|143182901|SUPERIORITY|||||||0.299||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 24h from baseline||||0.299
71837861|NCT03476460|143182902|SUPERIORITY|||||||0.477||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||Comparison between means of both arms at 48h from baseline||||0.477
71837862|NCT03476460|143182903|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.042||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.042
71837863|NCT03476460|143182904|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.121||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.121
71837864|NCT03476460|143182905|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.418||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.418
71837865|NCT03476460|143182906|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.901||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.901
71892434|NCT01381094|143306462|SUPERIORITY||||||=|0.5518|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5518
71892435|NCT01381094|143306462|SUPERIORITY||||||=|0.9032|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9032
71677201|NCT04143594|142873007|SUPERIORITY||Difference in LSM|0.08||||0.5755|TWO_SIDED|95.0|-0.2|0.37||P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.37|-0.20|0.5755
71837866|NCT03476460|143182907|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.72||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.720
71837867|NCT03476460|143182908|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.688||||||A p-value \<0.05 (two-sided) was considered for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.688
71837868|NCT03476460|143182909|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.535||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.535
71837869|NCT03476460|143182910|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.338||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.338
71837870|NCT03476460|143182911|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.764||||||A p-value \<0.05 (two-sided) was considered for statistical significance|t-test, 2 sided|||||||0.764
71837871|NCT03476460|143182912|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.458||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.458
71837872|NCT03476460|143182913|SUPERIORITY|Comparison between means of both arms at 24h from baseline||||||0.893||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.893
71837873|NCT03476460|143182914|SUPERIORITY|Comparison between means of both arms at 48h from baseline||||||0.645||||||A p-value \<0.05 (two-sided) was considered for statistical significance.|t-test, 2 sided|||||||0.645
71837874|NCT01606215|143182944|OTHER|||||||0.84|||||||t-test, 2 sided|||Week 4 data||||0.84
71837875|NCT01606215|143182944|OTHER|||||||0.62|||||||t-test, 2 sided|||Week 12 data||||0.62
71837876|NCT01606215|143182944|OTHER|||||||0.61|||||||t-test, 2 sided|||Week 24 data||||0.61
71837877|NCT01606215|143182947|OTHER|||||||0.77|||||||t-test, 2 sided|||Week 4||||0.77
71837878|NCT01606215|143182947|OTHER|||||||0.68|||||||t-test, 2 sided|||Week 12||||0.68
71837879|NCT01606215|143182947|OTHER|Week 24||||||0.48|||||||t-test, 2 sided|||Week 24||||0.48
71837880|NCT06132867|143182997|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90 percent (%) confidence intervals (CIs) were calculated using the exponentiation of the difference between treatment least square means (LSM) from the analyses on the natural log-transformed of Cmax.|Geometric Mean Ratio (GMR) (%)|92.2|||||TWO_SIDED|90.0|86.98|97.74|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||97.74|86.98|
71837881|NCT06132867|143182998|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUClast.|GMR (%)|96.0|||||TWO_SIDED|90.0|88.48|104.16|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||104.16|88.48|
71892436|NCT01381094|143306462|SUPERIORITY||||||=|0.2387|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2387
71757153|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.53||||0.4283|TWO_SIDED|95.0|0.1|2.64|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||2.64|0.10|0.4283
71757154|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-95.56|100.0||||||Role functioning, Post-Treatment Follow Up 24 Months||100.00|-95.56|
71757155|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.2153|TWO_SIDED|95.0|0.64|1.1|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 3 Day 1||1.10|0.64|0.2153
71757156|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.7878|TWO_SIDED|95.0|0.73|1.27|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 5 Day 1||1.27|0.73|0.7878
71757157|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.81||||0.1544|TWO_SIDED|95.0|0.61|1.08|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 8 Day 1||1.08|0.61|0.1544
71757158|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8017|TWO_SIDED|95.0|0.77|1.4|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 12 Day 1||1.40|0.77|0.8017
71757159|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.88||||0.4295|TWO_SIDED|95.0|0.63|1.21|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 16 Day 1||1.21|0.63|0.4295
71757160|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio, log|0.99||||0.954|TWO_SIDED|95.0|0.68|1.44|||Cochran-Mantel-Haenszel|||Social Functioning, Cycle 20 Day 1||1.44|0.68|0.9540
71757161|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.95||||0.7494|TWO_SIDED|95.0|0.69|1.3|||Cochran-Mantel-Haenszel|||Social Functioning, Completion of Treatment/ Early Termination Visit||1.30|0.69|0.7494
71757162|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.6412|TWO_SIDED|95.0|0.74|1.62|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 3 Months||1.62|0.74|0.6412
71757163|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.8652|TWO_SIDED|95.0|0.65|1.67|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 6 Months||1.67|0.65|0.8652
71789319|NCT05022784|143076572|OTHER|||||||0.37|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.37
71789320|NCT05022784|143076573|OTHER|||||||0.477|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.477
71789321|NCT05022784|143076574|OTHER|||||||0.644|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.644
71789322|NCT05022784|143076575|OTHER|||||||0.206|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.206
71789323|NCT05022784|143076576|OTHER|||||||0.052|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.052
71789324|NCT05022784|143076577|OTHER|||||||0.044|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.044
71789325|NCT05022784|143076578|OTHER|||||||0.525|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.525
71892437|NCT01381094|143306462|SUPERIORITY||||||=|0.4251|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.4251
71757164|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.14||||0.6912|TWO_SIDED|95.0|0.6|2.18|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 9 Months||2.18|0.60|0.6912
71757165|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.79||||0.5834|TWO_SIDED|95.0|0.33|1.86|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 12 Months||1.86|0.33|0.5834
71757166|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.93||||0.9578|TWO_SIDED|95.0|0.05|16.05|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 18 Months||16.05|0.05|0.9578
71757167|NCT03038100|143017624|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67||||0.5637|TWO_SIDED|95.0|-46.49|79.82|||Cochran-Mantel-Haenszel|||Social Functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|0.5637
71757168|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.6063|TWO_SIDED|95.0|0.75|1.63|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 3 Day 1||1.63|0.75|0.6063
71757169|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.9||||0.5739|TWO_SIDED|95.0|0.63|1.29|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 5 Day 1||1.29|0.63|0.5739
71757170|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.84||||0.3792|TWO_SIDED|95.0|0.56|1.25|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 8 Day 1||1.25|0.56|0.3792
71757171|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6022|TWO_SIDED|95.0|0.73|1.73|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 12 Day 1||1.73|0.73|0.6022
71757172|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.7893|TWO_SIDED|95.0|0.59|1.49|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 16 Day 1||1.49|0.59|0.7893
71757173|NCT03038100|143017625|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2125|TWO_SIDED|95.0|0.42|1.22|||Cochran-Mantel-Haenszel|||Emotional functioning, Cycle 20 Day 1||1.22|0.42|0.2125
71757174|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9661|TWO_SIDED|95.0|0.7|1.46|||Cochran-Mantel-Haenszel|||Emotional functioning, Completion of Treatment/ Early Termination Visit||1.46|0.70|0.9661
71757175|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.83||||0.4299|TWO_SIDED|95.0|0.52|1.32|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 3 Months||1.32|0.52|0.4299
71789326|NCT05022784|143076579|OTHER|||||||0.024|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.024
71789327|NCT05022784|143076580|OTHER|||||||0.016|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.016
71789328|NCT05022784|143076581|OTHER|||||||0.913|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.913
71789329|NCT05022784|143076582|OTHER|||||||0.448|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.448
71789330|NCT05022784|143076583|OTHER|||||||0.515|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.515
71837882|NCT06132867|143182999|OTHER|A linear mixed-effects analysis of variance model was used for the analysis. The model included sequence, treatment, and period as fixed effects and participants nested within sequence as a random effect. Geometric mean ratios and 90% CIs were calculated using the exponentiation of the difference between treatment LSM from the analyses on the natural log-transformed of AUCinf.|GMR (%)|95.84|||||TWO_SIDED|90.0|88.81|103.42|||||GMR (%) was calculated as 100\*(Treatment A/Treatment B).|||103.42|88.81|
71677202|NCT04143594|142873007|SUPERIORITY||Difference in LSM|0.02||||0.8697|TWO_SIDED|95.0|-0.25|0.29||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.29|-0.25|0.8697
71789331|NCT05022784|143076584|OTHER|||||||0.829|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.829
71837883|NCT04873401|143183001|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.928|TWO_SIDED|95.0|0.39|2.79|||Regression, Logistic|||||2.79|0.39|0.928
71837884|NCT04873401|143183002|SUPERIORITY||Median Difference (Final Values)|-0.173|STANDARD_ERROR_OF_MEAN|0.147||0.24|TWO_SIDED|95.0|-0.24|0.115|||Regression, Linear|||||0.115|-0.24|0.240
71837885|NCT04873401|143183003|SUPERIORITY||Slope|0.1171|STANDARD_ERROR_OF_MEAN|0.062||0.367|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.367
71837886|NCT04873401|143183004|SUPERIORITY||Slope|0.171|STANDARD_ERROR_OF_MEAN|0.062||0.005|TWO_SIDED|95.0|0.05|0.29|||Regression, Linear|||||0.29|0.05|0.005
71789332|NCT05022784|143076585|OTHER|||||||0.471|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.471
71789333|NCT05022784|143076586|OTHER|||||||0.915|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.915
71789334|NCT05022784|143076587|OTHER|||||||0.19|||||||Chi-squared|||||||0.190
71837887|NCT02921230|143183021|SUPERIORITY|||||||0.0077|||||||Chi-squared|||||||0.0077
71837888|NCT01926496|143183065|SUPERIORITY||Risk Ratio (RR)|0.89||||0.03|TWO_SIDED|95.0|0.8|0.99|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.99|0.80|0.03
71837889|NCT01926496|143183066|SUPERIORITY||Risk Ratio (RR)|0.95||||0.18|TWO_SIDED|95.0|0.87|1.03|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||1.03|0.87|0.18
71837890|NCT01926496|143183067|SUPERIORITY||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84|||Cochran-Mantel-Haenszel|Stratified by country, anatomical location and history of squamous cell carcinoma.|Cochran-Mantel-Haenszel relative risk (ingenol mebutate / imiquimod), stratified by country, anatomical location and history of squamous cell carcinoma.|||0.84|0.52|<0.001
71837891|NCT03064217|143183069|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71837892|NCT05546749|143183092|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.93||0.17|TWO_SIDED|95.0|-3.1|0.54|||Mixed Models Analysis|||A mixed effects model was performed to predict pain intensity by arm at weeks 3 and 6, controlling for baseline pain intensity score.||0.54|-3.1|0.17
71837893|NCT05546749|143183093|SUPERIORITY||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|13.6||0.32|TWO_SIDED|95.0|-40.3|13.1|||Mixed Models Analysis|||A mixed effects model was used to predict opioid craving score by arm at weeks 3 and 6, controlling for baseline opioid craving score.||13.1|-40.3|0.32
71837894|NCT05546749|143183102|SUPERIORITY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|6.1||0.137|TWO_SIDED|95.0|-23.1|3.6|||Regression, Linear||RelieVRx was associated with lower stress score.|We performed a mixed effects model to predict stress score at week 6 by arm, controlling for baseline stress score.||3.6|-23.1|0.137
71837895|NCT02100813|143183116|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.23|0.42|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.42|0.23|<0.001
71837896|NCT02100813|143183116|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.33|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||0.33|0.18|<0.001
71837897|NCT02100813|143183116|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79|||=|0.096|TWO_SIDED|95.0|0.59|1.04|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||1.04|0.59|=0.096
71837898|NCT02100813|143183117|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|7.02|||=|0.007|TWO_SIDED|95.0|1.53|124.0|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||124|1.53|=0.007
71677203|NCT04143594|142873007|SUPERIORITY||Difference in LSM|0.06||||0.7052|TWO_SIDED|95.0|-0.23|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.23|0.7052
71757176|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.65||||0.1542|TWO_SIDED|95.0|0.36|1.18|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 6 Months||1.18|0.36|0.1542
71837899|NCT02100813|143183117|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.82|||=|0.001|TWO_SIDED|95.0|1.99|154.5|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||154.5|1.99|=0.001
71837900|NCT02100813|143183117|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.26|||=|0.43|TWO_SIDED|95.0|0.72|2.31|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.31|0.72|=0.43
71837901|NCT02100813|143183118|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|8.73|||<|0.001|TWO_SIDED|95.0|2.93|51.66|||Log binomial regression|||||51.66|2.93|<0.001
71837902|NCT02100813|143183118|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|9.55|||<|0.001|TWO_SIDED|95.0|3.22|56.4|||Log binomial regression|||||56.4|3.22|<0.001
71837903|NCT02100813|143183118|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|1.09|||=|0.55|TWO_SIDED|95.0|0.81|1.49|||Log binomial regression|||||1.49|0.81|=0.55
71837904|NCT04359108|143183129|OTHER|||||||0.02|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.02
71837905|NCT04359108|143183129|OTHER|||||||0.22|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.22
71837906|NCT04359108|143183129|OTHER|||||||0.017|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.017
71837907|NCT04359108|143183129|OTHER|||||||0.98|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.98
71837908|NCT04359108|143183129|OTHER|||||||0.014|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.014
71837909|NCT04359108|143183129|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71837910|NCT04359108|143183129|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71837911|NCT04359108|143183129|OTHER|||||||0.156|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.156
71837912|NCT04359108|143183129|OTHER|||||||0.541|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.541
71837913|NCT04359108|143183129|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71837914|NCT04359108|143183129|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.10"|||
71671632|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-10.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||3|-10|
71789335|NCT05022784|143076588|OTHER|||||||0.928|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.928
71789336|NCT05022784|143076589|OTHER|||||||0.49|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.490
71789337|NCT05022784|143076590|OTHER|||||||0.667|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.667
71789338|NCT05022784|143076591|OTHER|||||||0.032|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.032
71789339|NCT05022784|143076592|OTHER|||||||0.721|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.721
71789340|NCT05022784|143076593|OTHER|||||||0.352|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.352
71789341|NCT05022784|143076594|OTHER|||||||0.136|||||||Chi-squared|||The statistical method applied in this analysis is Chi-squared hypothesis test, which tested if the count in each group was impacted by any confounding variable.||||0.136
71789342|NCT05022784|143076595|OTHER|||||||0.27|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.270
71789343|NCT05022784|143076596|OTHER|||||||0.306|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.306
71789344|NCT05022784|143076597|OTHER|||||||0.145|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.145
71837915|NCT04359108|143183129|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
71837916|NCT04359108|143183129|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.88"|||
71677204|NCT04143594|142873008|SUPERIORITY||Difference in LSM|0.02||||0.8942|TWO_SIDED|95.0|-0.26|0.3||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.30|-0.26|0.8942
71757177|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.65||||0.0363|TWO_SIDED|95.0|1.04|6.76|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 9 Months||6.76|1.04|0.0363
71757178|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.75||||0.0814|TWO_SIDED|95.0|0.85|8.93|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 12 Months||8.93|0.85|0.0814
71757179|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|4.03||||0.1915|TWO_SIDED|95.0|0.43|38.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 18 Months||38.00|0.43|0.1915
71757180|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|66.67||||0.3173|TWO_SIDED|95.0|-4.39|100.0|||Cochran-Mantel-Haenszel|||Emotional functioning, Post-Treatment Follow Up 24 Months||100.00|-4.39|0.3173
71757181|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9818|TWO_SIDED|95.0|0.73|1.35|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 3 Day 1||1.35|0.73|0.9818
71757182|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.08||||0.6263|TWO_SIDED|95.0|0.8|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 5 Day 1||1.45|0.80|0.6263
71757183|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9407|TWO_SIDED|95.0|0.73|1.4|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 8 Day 1||1.40|0.73|0.9407
71757184|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.64|1.39|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 12 Day 1||1.39|0.64|0.7700
71757185|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8458|TWO_SIDED|95.0|0.63|1.45|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 16 Day 1||1.45|0.63|0.8458
71757186|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.91||||0.7028|TWO_SIDED|95.0|0.57|1.46|||Cochran-Mantel-Haenszel|||Physical functioning, Cycle 20 Day 1||1.46|0.57|0.7028
71757187|NCT03038100|143017625|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1391|TWO_SIDED|95.0|0.92|1.83|||Cochran-Mantel-Haenszel|||Physical functioning, Completion of Treatment/ Early Termination Visit||1.83|0.92|0.1391
71757188|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.06||||0.8002|TWO_SIDED|95.0|0.69|1.62|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 3 Months||1.62|0.69|0.8002
71757189|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.01||||0.9751|TWO_SIDED|95.0|0.6|1.68|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 6 Months||1.68|0.60|0.9751
71757190|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.37||||0.3811|TWO_SIDED|95.0|0.68|2.78|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 9 Months||2.78|0.68|0.3811
71757191|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.51||||0.395|TWO_SIDED|95.0|0.58|3.9|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 12 Months||3.90|0.58|0.3950
71757192|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.89||||0.8993|TWO_SIDED|95.0|0.16|5.12|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 18 Months||5.12|0.16|0.8993
71757193|NCT03038100|143017625|SUPERIORITY|Stratified|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Physical functioning, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
71757194|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.92||||0.5988|TWO_SIDED|95.0|0.68|1.25|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 3 Day 1||1.25|0.68|0.5988
71757195|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8859|TWO_SIDED|95.0|0.72|1.34|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 5 Day 1||1.34|0.72|0.8859
71757196|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.82||||0.2531|TWO_SIDED|95.0|0.58|1.16|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Cycle 8 Day 1||1.16|0.58|0.2531
71757197|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.69||||0.0785|TWO_SIDED|95.0|0.46|1.04|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 12 Day 1||1.04|0.46|0.0785
71757198|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.67||||0.0641|TWO_SIDED|95.0|0.43|1.03|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 16 Day 1||1.03|0.43|0.0641
71757199|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.48||||0.0046|TWO_SIDED|95.0|0.29|0.8|||Cochran-Mantel-Haenszel|||Global health status/QoL, Cycle 20 Day 1||0.80|0.29|0.0046
71757200|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.98||||0.8928|TWO_SIDED|95.0|0.7|1.37|||Cochran-Mantel-Haenszel|||Global health status/QoL, Completion of Treatment/ Early Termination Visit||1.37|0.70|0.8928
71757201|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.12||||0.6106|TWO_SIDED|95.0|0.72|1.74|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 3 Months||1.74|0.72|0.6106
71837917|NCT04359108|143183129|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.6"|||
71837918|NCT04359108|143183129|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A \*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
71837919|NCT04359108|143183129|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.10"|||
71837920|NCT04359108|143183129|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.45"|||
71837921|NCT04359108|143183129|OTHER|||||||||||||||||Navigate to Destination Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.02"|||
71837922|NCT04359108|143183130|OTHER|||||||0.3|||||||ANOVA|||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||0.30
71837923|NCT04359108|143183130|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71837924|NCT04359108|143183130|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71837925|NCT04359108|143183130|OTHER|||||||0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.01
71837926|NCT04359108|143183130|OTHER|||||||0.93|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.93
71837927|NCT04359108|143183130|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71837928|NCT04359108|143183130|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.27"|||
71837929|NCT04359108|143183130|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.00"|||
71837930|NCT04359108|143183130|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.75"|||
71837931|NCT04359108|143183130|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.60"|||
71837932|NCT04359108|143183130|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
71837933|NCT04359108|143183130|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.72"|||
71677205|NCT04143594|142873008|SUPERIORITY||Difference in LSM|-0.02||||0.9058|TWO_SIDED|95.0|-0.28|0.25||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.25|-0.28|0.9058
71837934|NCT04359108|143183130|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.47"|||
71757202|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.15||||0.6159|TWO_SIDED|95.0|0.67|1.95|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 6 Months||1.95|0.67|0.6159
71757203|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.5372|TWO_SIDED|95.0|0.62|2.49|||Cochran-Mantel-Haenszel|Stratified Analysis||Global health status/QoL, Post-Treatment Follow Up 9 Months||2.49|0.62|0.5372
71757204|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22||||0.0845|TWO_SIDED|95.0|0.89|5.58|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 12 Months||5.58|0.89|0.0845
71757205|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|3.67||||0.1344|TWO_SIDED|95.0|0.62|21.56|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 18 Months||21.56|0.62|0.1344
71757206|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|50.0||||0.3173|TWO_SIDED|95.0|-23.34|100.0|||Cochran-Mantel-Haenszel|||Global health status/QoL, Post-Treatment Follow Up 24 Months||100.00|-23.34|0.3173
71757207|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.026|TWO_SIDED|95.0|1.04|1.92|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 3 Day 1||1.92|1.04|0.0260
71757208|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.02||||0.9179|TWO_SIDED|95.0|0.75|1.37|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 5 Day 1||1.37|0.75|0.9179
71757209|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.1||||0.582|TWO_SIDED|95.0|0.79|1.53|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 8 Day 1||1.53|0.79|0.5820
71757210|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.99||||0.9772|TWO_SIDED|95.0|0.67|1.47|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 12 Day 1||1.47|0.67|0.9772
71757211|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.73||||0.13|TWO_SIDED|95.0|0.49|1.1|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 16 Day 1||1.10|0.49|0.1300
71757212|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.66||||0.099|TWO_SIDED|95.0|0.4|1.08|||Cochran-Mantel-Haenszel|||Role functioning, Cycle 20 Day 1||1.08|0.40|0.0990
71757213|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.07||||0.7133|TWO_SIDED|95.0|0.76|1.5|||Cochran-Mantel-Haenszel|||Role functioning, Completion of Treatment/ Early Termination Visit||1.50|0.76|0.7133
71757214|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.38||||0.1384|TWO_SIDED|95.0|0.9|2.11|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 3 Months||2.11|0.90|0.1384
71757215|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.33||||0.2895|TWO_SIDED|95.0|0.78|2.26|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 6 Months||2.26|0.78|0.2895
71757216|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.55||||0.2221|TWO_SIDED|95.0|0.77|3.14|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 9 Months||3.14|0.77|0.2221
71757217|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|7.37||||0.0005|TWO_SIDED|95.0|2.08|26.1|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 12 Months||26.10|2.08|0.0005
71757218|NCT03038100|143017625|SUPERIORITY||Odds Ratio (OR)|3.72||||0.2171|TWO_SIDED|95.0|0.4|34.56|||Cochran-Mantel-Haenszel|||Role functioning, Post-Treatment Follow Up 18 Months||34.56|0.40|0.2171
71757219|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|16.67|||||TWO_SIDED|95.0|-46.49|79.82||||||Role functioning, Post-Treatment Follow Up 24 Months||79.82|-46.49|
71757220|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.11||||0.4647|TWO_SIDED|95.0|0.84|1.48|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 3 Day 1||1.48|0.84|0.4647
71757221|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.04||||0.7676|TWO_SIDED|95.0|0.78|1.4|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 5 Day 1||1.40|0.78|0.7676
71757222|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.24||||0.1983|TWO_SIDED|95.0|0.89|1.71|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 8 Day 1||1.71|0.89|0.1983
71757223|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.0||||0.9874|TWO_SIDED|95.0|0.69|1.44|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 12 Day 1||1.44|0.69|0.9874
71757224|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.86||||0.4716|TWO_SIDED|95.0|0.58|1.29|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 16 Day 1||1.29|0.58|0.4716
71757225|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.74||||0.2041|TWO_SIDED|95.0|0.46|1.18|||Cochran-Mantel-Haenszel|||Social functioning, Cycle 20 Day 1||1.18|0.46|0.2041
71757226|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.05||||0.7771|TWO_SIDED|95.0|0.76|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Completion of Treatment/ Early Termination Visit||1.45|0.76|0.7771
71757227|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|0.96||||0.8542|TWO_SIDED|95.0|0.64|1.45|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 3 Months||1.45|0.64|0.8542
71757228|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.5||||0.123|TWO_SIDED|95.0|0.9|2.5|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 6 Months||2.50|0.90|0.1230
71757229|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.72||||0.1089|TWO_SIDED|95.0|0.88|3.34|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 9 Months||3.34|0.88|0.1089
71757230|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|5.82||||0.0011|TWO_SIDED|95.0|1.85|18.3|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 12 Months||18.30|1.85|0.0011
71671633|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||TWO_SIDED|95.0|-12.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||0|-12|
71671634|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
71671635|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|2.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
71671636|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-2.0|7.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||7|-2|
71837935|NCT04359108|143183130|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 3.81"|||
71671637|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|6.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||6|-3|
71757231|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.51||||0.295|TWO_SIDED|95.0|0.43|14.74|||Cochran-Mantel-Haenszel|||Social functioning, Post-Treatment Follow Up 18 Months||14.74|0.43|0.2950
71757232|NCT03038100|143017625|SUPERIORITY|Stratified Analysis|Difference in Proportion of Responders|33.33|||||TWO_SIDED|95.0|-37.72|100.0||||||Social functioning, Post-Treatment Follow Up 24 Months||100.00|-37.72|
71757233|NCT02392624|143017630|SUPERIORITY||Clinical Worsening Rate Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-54.5|-22.5|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-22.5|-54.5|<0.0001
71757234|NCT02392624|143017631|SUPERIORITY||||||<|0.0001|||||||Log Rank|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||||<0.0001
71757235|NCT02392624|143017632|SUPERIORITY||Clinical Worsening Rate Difference|-32.1||||0.0004|TWO_SIDED|95.0|-47.9|-14.9|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.||-14.9|-47.9|0.0004
71757236|NCT02392624|143017633|OTHER||||||<|0.0001|||||||One-sample t-test, 1 sided|The p-value from this test was used to determine the importance of continued treatment in this study. P-value is one-sided with alpha = 0.05.||The null hypothesis for this test was that the mean change from Week 24 to Week 48 in UAS7 score was \>/=5 and the alternative hypothesis was that the mean change from Week 24 to Week 48 in UAS7 score was \<5.||||<0.0001
71757237|NCT02392624|143017634|OTHER||||||<|0.0001|||||||One-sample t-test, 2 sided|The p-value from this test was used to evaluate the importance of retreatment after experiencing clinical worsening.||The null hypothesis for this test was that the mean change from the time of retreatment to 12 weeks after retreatment in UAS7 was zero and the alternative hypothesis was that this change was non-zero.||||<0.0001
71757238|NCT03841604|143017651|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1695|TWO_SIDED|95.0|-1.75|0.32|||Mixed Model Repeated Measures|||||0.32|-1.75|0.1695
71757239|NCT03841604|143017652|OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.55||0.0784|TWO_SIDED|95.0|-2.1|0.12|||Mixed Model Repeated Measures|||||0.12|-2.1|0.0784
71757240|NCT03841604|143017653|OTHER||Risk Difference (RD)|-0.23||||0.0744|TWO_SIDED|95.0|-0.45|-0.01|||Cochran-Mantel-Haenszel|||||-0.01|-0.45|0.0744
71757241|NCT03841604|143017654|OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7247|TWO_SIDED|95.0|-0.7|0.49|||Mixed Model Repeated Measures|||||0.49|-0.70|0.7247
71837936|NCT04359108|143183131|OTHER||||||<|0.001|||||||ANOVA|navigation system mode and test block as factors||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71837937|NCT04359108|143183131|OTHER||||||<|0.01|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71837938|NCT04359108|143183131|OTHER|||||||0.037||||||within-participant, 2 sided t-test|t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.037
71757242|NCT03841604|143017655|OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9052|TWO_SIDED|95.0|-0.43|0.38|||Mixed Model Repeated Measures|||||0.38|-0.43|0.9052
71757243|NCT03841604|143017656|OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7115|TWO_SIDED|95.0|-0.61|0.88|||Mixed Model Repeated Measures|||||0.88|-0.61|0.7115
71757244|NCT03841604|143017657|SUPERIORITY||Risk Difference (RD)|0.04||||0.1967|TWO_SIDED|95.0|-0.04|0.12|||Cochran-Mantel-Haenszel|||||0.12|-0.04|0.1967
71757245|NCT03841604|143017658|SUPERIORITY||Risk Difference (RD)|0.06||||0.5122|TWO_SIDED|95.0|-0.13|0.26|||Cochran-Mantel-Haenszel|||||0.26|-0.13|0.5122
71757246|NCT03841604|143017660|OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.29||0.7376|TWO_SIDED|95.0|-3.03|2.16|||ANCOVA|||||2.16|-3.03|0.7376
71757247|NCT03841604|143017661|OTHER||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|3.92||0.5349|TWO_SIDED|95.0|-10.33|5.43|||Mixed Model Repeated Measures|||||5.43|-10.33|0.5349
71757248|NCT01774721|143017678|SUPERIORITY||Hazard Ratio (HR)|0.589|||<|0.0001|TWO_SIDED|95.0|0.469|0.739|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.739|0.469|<0.0001
71757249|NCT01774721|143017679|SUPERIORITY||Hazard Ratio (HR)|0.748||||0.0077|TWO_SIDED|95.0|0.591|0.947|||1-sided stratified log-rank test||Based on stratified Cox Regression model|||0.947|0.591|0.0077
71757250|NCT01774721|143017681|SUPERIORITY||Hazard Ratio (HR)|0.622|||<|0.0001|TWO_SIDED|95.0|0.497|0.779|||1-sided stratified log-rank test||Based on stratified Cox regression model|||0.779|0.497|<0.0001
71757251|NCT01774721|143017684|SUPERIORITY||Hazard Ratio (HR)|0.403|||<|0.0001|TWO_SIDED|95.0|0.307|0.529|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on IRC review||0.529|0.307|<0.0001
71757252|NCT01774721|143017684|SUPERIORITY||Hazard Ratio (HR)|0.545|||<|0.0001|TWO_SIDED|95.0|0.418|0.711|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on Investigator assessment||0.711|0.418|<0.0001
71757253|NCT01774721|143017685|SUPERIORITY|||||||0.1942|||||||Cochran-Mantel-Haenszel|||||||0.1942
71757254|NCT01774721|143017686|SUPERIORITY|||||||0.0924|||||||Cochran-Mantel-Haenszel|||||||0.0924
71757255|NCT01774721|143017693|SUPERIORITY||Cox Proportional Hazard|1.173||||0.1641|TWO_SIDED|95.0|0.928|1.483|||Unstratified Log-rank Test|||||1.483|0.928|0.1641
71757256|NCT01907854|143017725|SUPERIORITY_OR_OTHER||Treatment difference|-0.61|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.4|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.||-0.40|-0.82|<0.0001
71757257|NCT01907854|143017726|SUPERIORITY_OR_OTHER||Treatment difference|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.34|-0.99|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and \>8.5%), metformin dose (\<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.||-0.99|-2.34|<0.0001
71757258|NCT01208207|143017778|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|-0.64|||||TWO_SIDED|95.0|-5.47|4.19|||ANCOVA|||||4.19|-5.47|
71757259|NCT01208207|143017779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|1.59|||||TWO_SIDED|95.0|-2.19|5.37|||ANCOVA|||||5.37|-2.19|
71757260|NCT01208207|143017780|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-1.58||||0.396|TWO_SIDED|80.0|-3.96|0.81|||ANCOVA|||||0.81|-3.96|0.396
71757261|NCT01208207|143017781|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-2.7||||0.112||80.0|-4.88|-0.52|||ANCOVA|||||-0.52|-4.88|0.112
71757262|NCT01929317|143017852|SUPERIORITY_OR_OTHER||Mean change from Baseline|-4.8|||<|0.001|TWO_SIDED|95.0|-6.3|-3.2|||t-test, 1 sided|||||-3.2|-6.3|<0.001
71757263|NCT01929317|143017853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 2.|||2.0|-2.4|
71757264|NCT01929317|143017853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.9|3.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 4.|||3.1|-1.9|
71757265|NCT01929317|143017853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.3|3.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 6.|||3.0|-2.3|
71757266|NCT01929317|143017853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 8.|||2.0|-3.4|
71757267|NCT01929317|143017853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-2.0|3.9|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 12.|||3.9|-2.0|
71757268|NCT01929317|143017855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 2.|||0.3|-0.2|
71757269|NCT01929317|143017855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 4.|||0.4|-0.2|
71757270|NCT01929317|143017855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.4|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 6.|||0.3|-0.4|
71757271|NCT01929317|143017855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.3|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 8.|||0.3|-0.3|
71757272|NCT01929317|143017855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 12.|||0.6|-0.2|
71757273|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.8|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, On status.|||0.1|-1.8|
71757274|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.4|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, On status.|||0.1|-2.4|
71757275|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-2.6|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, On status.|||0.3|-2.6|
71757276|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.8|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, On status.|||0.3|-2.8|
71757277|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, On status.|||0.7|-2.7|
71757278|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.8|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, Off status.|||0.5|-1.8|
71757279|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.6|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, Off status.|||0.8|-2.6|
71789345|NCT05022784|143076598|OTHER|||||||0.109|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.109
71757280|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-2.8|1.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, Off status.|||1.0|-2.8|
71757281|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.1|1.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, Off status.|||1.8|-2.1|
71757282|NCT01929317|143017856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, Off status.|||2.1|-2.2|
71757283|NCT01929317|143017857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 2.|||0.4|-0.7|
71757284|NCT01929317|143017857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.7|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 4.|||0.6|-0.7|
71757285|NCT01929317|143017857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 6.|||0.8|-0.7|
71789346|NCT05022784|143076599|OTHER|||||||0.454|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.454
71789347|NCT05022784|143076600|OTHER|||||||0.96|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.960
71789348|NCT05022784|143076601|OTHER|||||||0.265|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.265
71789349|NCT05022784|143076602|OTHER|||||||0.026|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.026
71789350|NCT05022784|143076603|OTHER|||||||0.016|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.016
71789351|NCT05022784|143076604|OTHER|||||||0.937|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.937
71789352|NCT05022784|143076605|OTHER|||||||0.948|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.948
71789353|NCT05022784|143076606|OTHER|||||||0.574|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.574
71671638|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
71757286|NCT01929317|143017857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 8.|||0.7|-0.7|
71757287|NCT01929317|143017857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 12.|||0.5|-0.9|
71789354|NCT05022784|143076607|OTHER|||||||0.491|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.491
71789355|NCT05022784|143076608|OTHER|||||||0.432|||||||ANOVA|||The statistical method applied in this analysis is Analysis of Variance (ANOVA), which compared the mean value in each group and tests if they are significantly different via a fixed-effect regression model.||||0.432
71789356|NCT00708162|143076609|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-6.0|8.2|||||The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.|The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA \< 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.||8.2|-6.0|
71789357|NCT00708162|143076610|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA \< 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.|Difference in percentages|2.6|||||TWO_SIDED|95.0|-4.6|9.9|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.9|-4.6|
71789358|NCT00708162|143076611|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.0|7.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.7|-6.0|
71789359|NCT00708162|143076612|SUPERIORITY_OR_OTHER||Difference in percentages|0.9|||||TWO_SIDED|95.0|-6.4|8.2|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||8.2|-6.4|
71789360|NCT00708162|143076613|SUPERIORITY_OR_OTHER||Difference in percentages|2.2|||||TWO_SIDED|95.0|-5.0|9.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||9.3|-5.0|
71789361|NCT00708162|143076614|SUPERIORITY_OR_OTHER||Difference in percentages|-0.5|||||TWO_SIDED|95.0|-7.9|6.8|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||6.8|-7.9|
71789362|NCT00708162|143076619|SUPERIORITY_OR_OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-6.9|7.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||7.3|-6.9|
71789363|NCT00708162|143076620|SUPERIORITY_OR_OTHER||Difference in percentages|-2.9|||||TWO_SIDED|95.0|-10.2|4.4|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.4|-10.2|
71789364|NCT00708162|143076621|SUPERIORITY_OR_OTHER||Difference in percentages|-2.0|||||TWO_SIDED|95.0|-8.6|4.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||4.7|-8.6|
71757288|NCT01929317|143017870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.65|1.04|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 2."|||1.04|-1.65|
71757289|NCT01929317|143017870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-1.34|1.45|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 4."|||1.45|-1.34|
71789365|NCT00708162|143076622|SUPERIORITY_OR_OTHER||Difference in percentages|-1.7|||||TWO_SIDED|95.0|-8.8|5.5|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.|||5.5|-8.8|
71789366|NCT00708162|143076623|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.01|||||TWO_SIDED|95.0|-0.16|0.19|||||The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.19|-0.16|
71789367|NCT00708162|143076624|SUPERIORITY_OR_OTHER||Difference in log10 copies/mL|0.05|||||TWO_SIDED|95.0|-0.12|0.22|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||0.22|-0.12|
71671639|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
71837939|NCT04359108|143183131|OTHER|||||||0.34|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.34
71837940|NCT04359108|143183131|OTHER|||||||0.1|||||||t-test, 2 sided|within-participant, 2 sided t-test||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||0.10
71837941|NCT04359108|143183131|OTHER||||||<|0.001|||||||ANOVA|||Obstacle Avoidance Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71837942|NCT04359108|143183131|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71837943|NCT04359108|143183131|OTHER|||||||0.67|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.67
71837944|NCT04359108|143183131|OTHER|||||||0.23|||||||t-test, 2 sided|||Obstacle Avoidance Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.23
71837945|NCT04359108|143183131|OTHER||||||<|0.01|||||||t-test, 2 sided|||Obstacle Avoidance Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71677206|NCT04143594|142873008|SUPERIORITY||Difference in LSM|0.04||||0.8129|TWO_SIDED|95.0|-0.27|0.35||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.35|-0.27|0.8129
71757290|NCT01929317|143017870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.95|1.24|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 6."|||1.24|-1.95|
71837946|NCT04359108|143183131|OTHER|||||||||||||||||Obstacle Avoidance Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.79"|||
71837947|NCT04359108|143183131|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 1.38"|||
71837948|NCT04359108|143183131|OTHER|||||||||||||||||Obstacle Avoidance Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 2.24"|||
71837949|NCT04359108|143183131|OTHER|||||||||||||||||Obstacle Avoidance Test - Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.85"|||
71837950|NCT04359108|143183131|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = N/A\*~\* N/A for Argus Vision test because subject did not successfully reach intended destination for any trial using this mode."|||
71837951|NCT04359108|143183131|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = 0.18"|||
71837952|NCT04359108|143183131|OTHER|||||||||||||||||Navigate to Destination Test - Depth Vision + Haptic/Audio: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -0.97"|||
71837953|NCT04359108|143183131|OTHER|||||||||||||||||Navigate to Destination Test - Argus Vision: test for null hypothesis that the single Argus participant in this arm has performance that lies in-distribution with performance statistics computed for the normally sighted subjects arm of the study.|"Test Method: Z-Score comparison of the performance of the single Argus participant to the performance distribution of normally sighted subjects.~Significance threshold: \|Z\| = 2.8 for p = 0.05, 2-tailed (reject null hypothesis above threshold) Result: Z-Score = -1.23"|||
71837954|NCT04359108|143183132|OTHER||||||<|0.001|||||||ANOVA|Single-factor test on navigation system mode||Navigate to Destination Test - Significance of Navigation Mode: test for null hypothesis of equivalent performance among all navigation system modes||||<0.001
71837955|NCT04359108|143183132|OTHER|||||||0.17|||||||t-test, 2 sided|||Navigate to Destination Test - Argus Vision vs. Depth Vision: test for null hypothesis of equivalent performance||||0.17
71671640|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||4|-2|
71671641|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
71671642|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||2|-8|
71671643|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||5|-5|
71757291|NCT01929317|143017870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-2.44|0.75|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 8."|||0.75|-2.44|
71757292|NCT01929317|143017870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07|||||TWO_SIDED|95.0|-2.73|0.58|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 12."|||0.58|-2.73|
71837956|NCT04359108|143183132|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||<0.01
71837957|NCT04359108|143183132|OTHER|||||||0.33|||||||t-test, 2 sided|||Navigate to Destination Test - Haptic/Audio vs. Depth Vision + Haptic/Audio: test for null hypothesis of equivalent performance||||0.33
71837958|NCT04359108|143183132|OTHER||||||<|0.01|||||||t-test, 2 sided|||Navigate to Destination Test - Depth Vision vs. High Field-of-View Depth Vision: test for null hypothesis of equivalent performance||||<0.01
71671644|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-9.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-9|
71757293|NCT01929317|143017871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|95.0|-8.77|6.71|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 2."|||6.71|-8.77|
71837959|NCT04359108|143183133|OTHER|||||||0.023|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high resolution vision modes||||0.023
71837960|NCT04359108|143183133|OTHER|||||||0.039|||||||ANOVA|2X2 within-participant test with factors of resolution and field-of-view||Significance of Resolution: test for null hypothesis of equivalent performance between low and high field-of-view vision modes||||0.039
71837961|NCT04359108|143183133|OTHER|||||||0.801|||||||ANOVA|2x2 within-participant test with factors of resolution and field-of-view||Significance of Interaction between Resolution and Field-of-View: test for null hypothesis of no interaction||||.801
71837962|NCT03652688|143183134|SUPERIORITY||F|14.463|||<|0.001|TWO_SIDED||||||ANOVA|||The unit of analyses was the individual, nested within groups.||||<0.001
71837963|NCT03652688|143183135|SUPERIORITY|||||||0.08|||||||Chi-squared, Corrected|||||||.08
71837964|NCT03652688|143183136|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||||||0.954
71837965|NCT03652688|143183137|SUPERIORITY||Chi-Square|4.436||||0.035|TWO_SIDED||||||Chi-squared, Corrected|||||||.035
71837966|NCT03652688|143183138|SUPERIORITY||Chi-Square|2.615||||0.106|TWO_SIDED||||||Chi-squared, Corrected|||||||.106
71837967|NCT03652688|143183139|SUPERIORITY||Chi-Square|11.636|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71671645|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||1|-11|
71677207|NCT04143594|142873009|SUPERIORITY||Difference in LSM|0.04||||0.7864|TWO_SIDED|95.0|-0.25|0.33||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.33|-0.25|0.7864
71837968|NCT04749615|143183196|NON_INFERIORITY|Noninferiority Margin = (-Infinity, 1.28)||||||0.11|||||||t-test, 1 sided|||||||0.11
71837969|NCT04749615|143183197|NON_INFERIORITY|a noninferiority margin of 1.0 and 10% attrition|Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0||||this is the calculated p-value.|t-test, 2 sided|||||||0.5
71837970|NCT03736720|143183224|OTHER|No statistical test.|Proportion|0.091|||||TWO_SIDED|80.0|0.033|0.301|||||Estimated using Jeffrey's prior method.|||0.301|0.033|
71837971|NCT03736720|143183230|SUPERIORITY|||||||0.289|||||||Sign test|two-sided test.||Comparing the pre-treatment and end of treatment QoL scores.||||0.289
71837972|NCT03194217|143183236|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.68|1.08|||ANCOVA|||||1.08|-1.68|0.668
71837973|NCT03194217|143183236|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.7||0.213|TWO_SIDED|95.0|-0.5|2.26|||ANCOVA|||||2.26|-0.50|0.213
71837974|NCT03194217|143183236|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.7||0.575|TWO_SIDED|95.0|-1.76|0.98|||ANCOVA|||||0.98|-1.76|0.575
71837975|NCT05894577|143183239|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.92|1.12|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.12|0.92|
71837976|NCT05894577|143183240|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.14|7.07|||||Low event rate precluded covariate adjustment.|No hypothesis test or decision rule was evaluated.||7.07|0.14|
71837977|NCT05894577|143183243|SUPERIORITY|Posterior probability of efficacy (P(HR\<1))|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.45|1.84|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.84|0.45|
71837978|NCT05894577|143183244|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.31|||||TWO_SIDED|95.0|0.5|2.29|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.29|0.50|
71837979|NCT05894577|143183245|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.16|1.49|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.49|0.16|
71837980|NCT05894577|143183246|SUPERIORITY|Posterior probability of efficacy (P(OR\<1))|Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.33|2.96|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||2.96|0.33|
71837981|NCT05894577|143183247|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.71|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.71|
71837982|NCT05894577|143183247|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.75|1.51|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.51|0.75|
71837983|NCT05894577|143183247|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.88|0.84|
71837984|NCT05894577|143183247|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.65|1.6|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.60|0.65|
71837985|NCT05894577|143183247|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.57|1.36|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.36|0.57|
71837986|NCT05894577|143183247|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.69|2.0|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||2.00|0.69|
71837987|NCT05894577|143183248|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.15|0.66|
71757294|NCT01929317|143017871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-7.94|8.22|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 4."|||8.22|-7.94|
71757295|NCT01929317|143017871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.78|||||TWO_SIDED|95.0|-12.06|6.49|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 6."|||6.49|-12.06|
71757296|NCT01929317|143017871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.46|||||TWO_SIDED|95.0|-14.06|5.14|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 8."|||5.14|-14.06|
71757297|NCT01929317|143017871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98|||||TWO_SIDED|95.0|-15.92|3.96|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 12."|||3.96|-15.92|
71757298|NCT01929317|143017872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||||TWO_SIDED|95.0|-1.07|1.21|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 2."|||1.21|-1.07|
71757299|NCT01929317|143017872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-0.75|1.7|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 4."|||1.70|-0.75|
71757300|NCT01929317|143017872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.65|1.86|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 6."|||1.86|-0.65|
71671646|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-8.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).||4|-8|
71757301|NCT01929317|143017872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.52|2.22|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 8."|||2.22|-0.52|
71757302|NCT01929317|143017872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||||TWO_SIDED|95.0|-0.55|2.26|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 12."|||2.26|-0.55|
71757303|NCT01929317|143017873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.98|1.36|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 2."|||1.36|-0.98|
71757304|NCT01929317|143017873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|||||TWO_SIDED|95.0|-0.64|1.78|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 4."|||1.78|-0.64|
71757305|NCT01929317|143017873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-0.71|1.84|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 6."|||1.84|-0.71|
71757306|NCT01929317|143017873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-0.47|2.39|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 8."|||2.39|-0.47|
71757307|NCT01929317|143017873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|||||TWO_SIDED|95.0|-0.63|2.33|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 12."|||2.33|-0.63|
71789368|NCT00708162|143076625|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|-9.0|||||TWO_SIDED|95.0|-33.0|16.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||16|-33|
71757308|NCT04322526|143017883|OTHER|||||||0.01|||||||t-test, 2 sided|||Changes in BOLD signal in the rACC during the processing of contextual cues (pleasant \> unpleasant).||||0.01
71757309|NCT04322526|143017884|OTHER|Mechanistic hypothesis: naltrexone will block contextual processing.||||||0.0002|||||||t-test, 2 sided|||Changes in BOLD fMRI signal from the Placebo vs. the Naltrexone session.||||0.0002
71789369|NCT00708162|143076626|SUPERIORITY_OR_OTHER||Difference in cells/mm^3|7.0|||||TWO_SIDED|95.0|-25.0|39.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).|||39|-25|
71789370|NCT00708643|143076627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0047|STANDARD_ERROR_OF_MEAN|2.2863|||TWO_SIDED|98.75|-3.0047|2.7153|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.||2.7153|-3.0047|
71671647|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-3.0|5.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)||5|-3|
71671648|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
71789371|NCT00708643|143076628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0804|STANDARD_ERROR_OF_MEAN|0.7605|||TWO_SIDED|99.0|-0.0804|1.8821|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.||1.8821|-0.0804|
71789372|NCT00708643|143076629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2228|STANDARD_ERROR_OF_MEAN|1.7002|||TWO_SIDED|99.0|0.2228|4.6564|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.||4.6564|0.2228|
71789373|NCT00708643|143076630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2596|STANDARD_ERROR_OF_MEAN|1.1873|||TWO_SIDED|98.75|1.2596|4.2599|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus the habitual lens.|||4.2599|1.2596|
71789374|NCT00708643|143076631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8625|STANDARD_ERROR_OF_MEAN|2.3407|||TWO_SIDED|98.75|-0.8625|5.0524|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.||5.0524|-0.8625|
71789375|NCT00708643|143076632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|1.6975|||TWO_SIDED|98.75|-0.241|4.0043|||Mixed Models Analysis||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.||4.0043|-0.2410|
71789376|NCT04309656|143076700|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|85.85||||0.0001|TWO_SIDED|90.0|81.21|90.75|||ANOVA|||||90.75|81.21|0.0001
71789377|NCT04309656|143076700|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|92.99||||0.3001|TWO_SIDED|90.0|82.65|104.62|||ANOVA|||||104.62|82.65|0.3001
71671649|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-4.0|4.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).||4|-4|
71677208|NCT04143594|142873009|SUPERIORITY||Difference in LSM|-0.05||||0.7013|TWO_SIDED|95.0|-0.31|0.21||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.21|-0.31|0.7013
71789378|NCT04309656|143076701|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|100.6||||0.6686|TWO_SIDED|90.0|98.23|103.03|||ANOVA|||||103.03|98.23|0.6686
71789379|NCT04309656|143076701|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.7||||0.0745|TWO_SIDED|90.0|81.2|99.1|||ANOVA|||||99.10|81.20|0.0745
71789380|NCT04309656|143076702|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|101.03||||0.4683|TWO_SIDED|90.0|98.65|103.47|||ANOVA|||||103.47|98.65|0.4683
71789381|NCT04309656|143076702|EQUIVALENCE|Comparisons performed: Treatment B (test) versus Treatment A (reference). Relative bioavailability of test compared to reference assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model.|Geometric mean ratio (%)|89.63||||0.0734|TWO_SIDED|90.0|81.1|99.05|||ANOVA|||||99.05|81.10|0.0734
71757310|NCT00935584|143017981|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
71757311|NCT00935584|143017981|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||>0.05
71757312|NCT00935584|143017982|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
71757313|NCT00935584|143017982|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wicoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||>0.05
71757314|NCT00935584|143017983|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
71757315|NCT00935584|143017983|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.||||>0.05
71757316|NCT00935584|143017984|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71757317|NCT00935584|143017984|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71757318|NCT00935584|143017985|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
71789382|NCT03720470|143076707|SUPERIORITY||Difference in percentage|23.1|||<|0.0001|TWO_SIDED|95.0|14.7|31.4|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and confidence interval (CI) for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||31.4|14.7|<0.0001
71789383|NCT03720470|143076707|SUPERIORITY||Difference in Percentage|34.8|||<|0.0001|TWO_SIDED|95.0|26.1|43.5|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.5|26.1|<0.0001
71789384|NCT03720470|143076708|SUPERIORITY||Difference in percentage|31.9|||<|0.0001|TWO_SIDED|95.0|22.2|41.6|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||41.6|22.2|<0.0001
71789385|NCT03720470|143076708|SUPERIORITY||Difference in Percentage|43.2|||<|0.0001|TWO_SIDED|95.0|33.7|52.7|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||52.7|33.7|<0.0001
71837988|NCT05894577|143183248|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.63|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.14|0.63|
71677209|NCT04143594|142873009|SUPERIORITY||Difference in LSM|0.22||||0.2753|TWO_SIDED|95.0|-0.18|0.62||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.62|-0.18|0.2753
71757319|NCT00935584|143017985|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.||||<0.05
71837989|NCT05894577|143183248|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.56|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.56|
71757320|NCT00935584|143017986|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71757321|NCT00935584|143017986|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.||||<0.05
71757322|NCT03863080|143018077|SUPERIORITY||Least square mean difference|-56.33|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Total IgG levels has been presented.|||||<0.0001
71757323|NCT03863080|143018077|SUPERIORITY||Least square mean difference|-74.49|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Total IgG levels has been presented.|||||<0.0001
71757324|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-62.7|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 1 subclass has been presented.|||||<0.001
71757325|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-73.0|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 1 subclass has been presented.|||||<0.001
71757326|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-52.5|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 2 subclass has been presented.|||||<0.001
71789386|NCT03720470|143076709|SUPERIORITY||Difference in percentage|17.9||||0.0002|TWO_SIDED|95.0|9.5|26.3|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||26.3|9.5|0.0002
71757327|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-61.4|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 2 subclass has been presented.|||||<0.001
71757328|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-66.1|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 3 subclass has been presented.|||||<0.001
71757329|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-80.8|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 3 subclass has been presented.|||||<0.001
71757330|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-44.9|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of IgG 4 subclass has been presented.|||||<0.001
71757331|NCT03863080|143018078|SUPERIORITY||Least square mean difference|-61.6|||<|0.001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of IgG 4 subclass has been presented.|||||<0.001
71757332|NCT03863080|143018079|SUPERIORITY||Least square mean difference|-62.58||||0.0009|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 340 mg/week of Anti-AChR-IgG has been presented.|||||0.0009
71757333|NCT03863080|143018079|SUPERIORITY||Least square mean difference|-101.2|||<|0.0001|TWO_SIDED||||||ANCOVA||Treatment comparison between Placebo and RVT-1401 680 mg/week of Anti-AChR-IgG has been presented.|||||<0.0001
71757334|NCT01342211|143018095|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|-5.63|STANDARD_ERROR_OF_MEAN|9.759||0.5661|TWO_SIDED|95.0|-25.09|13.83|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||13.83|-25.09|0.5661
71757335|NCT01342211|143018095|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|9.422||0.808|TWO_SIDED|95.0|-21.08|16.49|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||16.49|-21.08|0.8080
71757336|NCT01342211|143018095|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.72|STANDARD_ERROR_OF_MEAN|9.404||0.0001|TWO_SIDED|95.0|-56.47|-18.97|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-18.97|-56.47|0.0001
71757337|NCT01342211|143018095|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.11|STANDARD_ERROR_OF_MEAN|9.514|<|0.0001|TWO_SIDED|95.0|-68.08|-30.14|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.||-30.14|-68.08|<0.0001
71757338|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.172||||0.8998|TWO_SIDED|95.0|0.1|13.92|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||13.92|0.10|0.8998
71757339|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.063||||0.5273|TWO_SIDED|95.0|0.22|19.48|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||19.48|0.22|0.5273
71757340|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|53.924||||0.0004|TWO_SIDED|95.0|5.93|490.67|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||490.67|5.93|0.0004
71757341|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|280.366|||<|0.0001|TWO_SIDED|95.0|18.65|4214.35|||Regression, Logistic|||Day 29, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||4214.35|18.65|<0.0001
71789387|NCT03720470|143076709|SUPERIORITY||Difference in Percentage|34.9|||<|0.0001|TWO_SIDED|95.0|26.0|43.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.0|<.0001
71677210|NCT04143594|142873010|SUPERIORITY||Difference in LSM|0.08||||0.564|TWO_SIDED|95.0|-0.19|0.34||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.34|-0.19|0.5640
71757342|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.262||||0.086|TWO_SIDED|95.0|0.06|1.21|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.21|0.06|0.0860
71757343|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.4308|TWO_SIDED|95.0|0.15|2.25|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||2.25|0.15|0.4308
71757344|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.272||||0.0127|TWO_SIDED|95.0|1.57|43.56|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.56|1.57|0.0127
71757345|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.528||||0.0096|TWO_SIDED|95.0|1.89|97.0|||Regression, Logistic|||Day 29, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||97.00|1.89|0.0096
71757346|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||0.9519|TWO_SIDED|95.0|0.02|61.54|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||61.54|0.02|0.9519
71757347|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.069||||0.974|TWO_SIDED|95.0|0.02|58.0|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||58.00|0.02|0.9740
71757348|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.286||||0.0273|TWO_SIDED|95.0|1.46|549.78|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||549.78|1.46|0.0273
71789388|NCT03720470|143076709|SUPERIORITY||Difference in Percentage|5.2||||0.2084|TWO_SIDED|95.0|-2.9|13.4|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||13.4|-2.9|0.2084
71837990|NCT05894577|143183248|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.73|1.45|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.45|0.73|
71671650|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||TWO_SIDED|95.0|-5.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||1|-5|
71671651|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||2|-4|
71757349|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|114.508||||0.0022|TWO_SIDED|95.0|5.5|2384.03|||Regression, Logistic|||Day 57, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||2384.03|5.50|0.0022
71757350|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.216||||0.0684|TWO_SIDED|95.0|0.04|1.12|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||1.12|0.04|0.0684
71757351|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.081||||0.9068|TWO_SIDED|95.0|0.29|3.99|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||3.99|0.29|0.9068
71757352|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.251||||0.2235|TWO_SIDED|95.0|0.61|8.31|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||8.31|0.61|0.2235
71757353|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25||||0.012|TWO_SIDED|95.0|1.59|42.82|||Regression, Logistic|||Day 57, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||42.82|1.59|0.0120
71757354|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.5449|TWO_SIDED|95.0|0.01|9.92|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||9.92|0.01|0.5449
71757355|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.5585|TWO_SIDED|95.0|0.22|16.85|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||16.85|0.22|0.5585
71757356|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.059||||0.0022|TWO_SIDED|95.0|3.0|147.65|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||147.65|3.00|0.0022
71757357|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.851||||0.002|TWO_SIDED|95.0|3.15|165.99|||Regression, Logistic|||Day 85, \<70 mg/dL: The standard logistic regression model was used to assess treatment effect.||165.99|3.15|0.0020
71757358|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.375|TWO_SIDED|95.0|0.48|7.12|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||7.12|0.48|0.3750
71757359|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078||||0.914|TWO_SIDED|95.0|0.28|4.23|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||4.23|0.28|0.9140
71757360|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.548||||0.0036|TWO_SIDED|95.0|2.09|43.57|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||43.57|2.09|0.0036
71757361|NCT01342211|143018096|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.093||||0.0149|TWO_SIDED|95.0|1.42|26.1|||Regression, Logistic|||Day 85, \<100 mg/dL: The standard logistic regression model was used to assess treatment effect.||26.10|1.42|0.0149
71757362|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.674||||0.5436|TWO_SIDED|95.0|0.32|8.83|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||8.83|0.32|0.5436
71757363|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.734||||0.742|TWO_SIDED|95.0|0.12|4.63|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||4.63|0.12|0.7420
71757364|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.151||||0.0002|TWO_SIDED|95.0|4.73|167.62|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||167.62|4.73|0.0002
71757365|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.214||||0.0001|TWO_SIDED|95.0|7.88|643.42|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.||643.42|7.88|0.0001
71757366|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.203||||0.321|TWO_SIDED|95.0|0.01|4.74|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||4.74|0.01|0.3210
71757367|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.3786|TWO_SIDED|95.0|0.39|12.27|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||12.27|0.39|0.3786
71757368|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.576||||0.0144|TWO_SIDED|95.0|1.5|38.38|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||38.38|1.50|0.0144
71757369|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.465||||0.0007|TWO_SIDED|95.0|3.59|116.6|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.||116.60|3.59|0.0007
71757370|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.161||||0.8626|TWO_SIDED|95.0|0.21|6.3|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||6.30|0.21|0.8626
71757371|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.497||||0.6237|TWO_SIDED|95.0|0.3|7.51|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||7.51|0.30|0.6237
71757372|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.029||||0.0072|TWO_SIDED|95.0|1.76|36.65|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||36.65|1.76|0.0072
71757373|NCT01342211|143018097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.557||||0.0005|TWO_SIDED|95.0|3.73|113.2|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.||113.20|3.73|0.0005
71757374|NCT06482125|143018112|SUPERIORITY||Odds Ratio (OR)|40.955||||0.001|TWO_SIDED|95.0|14.098|118.972|||Chi-squared, Corrected|||||118.972|14.098|0.001
71757375|NCT06482125|143018113|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.345|||||||Wilcoxon (Mann-Whitney)|||||||0.345
71757376|NCT06482125|143018114|EQUIVALENCE|The threshold for statistical significance is p \< 0.05||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.450
71757377|NCT06482125|143018115|EQUIVALENCE|Reject H0 = the means are equivalent|Median Difference (Net)|1.0||||0.356|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.356
71757378|NCT06482125|143018116|EQUIVALENCE|Reject H0 = the means are equivalent|Mean Difference (Final Values)|8.202||||0.07|TWO_SIDED|95.0|2.31|14.095|||t-test, 2 sided|||||14.095|2.310|0.07
71757379|NCT05786651|143018156|EQUIVALENCE|Comparison of conditions|||||<|0.05|||||||ANOVA|||||||<.05
71757380|NCT05786651|143018157|EQUIVALENCE|Comparisons of mean values of conditions|||||<|0.05|||||||ANOVA|||||||<.05
71757381|NCT04390763|143018163|OTHER||Hazard Ratio (HR)|0.7|||||ONE_SIDED|90.0||1.04|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.04||
71757382|NCT04390763|143018163|OTHER||Hazard Ratio (HR)|1.41|||||ONE_SIDED|90.0||1.96|||Bayesian two-piece hazard model||Estimated posterior median of the HR after the risk changing timepoint and one-sided 90% credible interval are reported.|||1.96||
71757383|NCT04390763|143018164|OTHER||Hazard Ratio (HR)|1.02||||0.46|ONE_SIDED|90.0||1.37|||Regression, Cox|||||1.37||0.46
71757384|NCT04390763|143018164|OTHER||Hazard Ratio (HR)|1.08||||0.38|ONE_SIDED|90.0||1.44|||Regression, Cox|||||1.44||0.38
71757385|NCT00554216|143018213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.36|STANDARD_ERROR_OF_MEAN|0.476|<|0.0001|TWO_SIDED|95.0|8.43|10.3||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||10.30|8.43|<0.0001
71837991|NCT05894577|143183248|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.71|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.40|0.71|
71837992|NCT05894577|143183248|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.60|
71757386|NCT00554216|143018213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|2.38|4.71||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.71|2.38|<0.0001
71757387|NCT00554216|143018213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.82|STANDARD_ERROR_OF_MEAN|0.596|<|0.0001|TWO_SIDED|95.0|4.65|6.99||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||6.99|4.65|<0.0001
71757388|NCT00554216|143018214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.61|STANDARD_ERROR_OF_MEAN|1.463|<|0.0001|TWO_SIDED|95.0|7.13|12.95||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||12.95|7.13|<0.0001
71837993|NCT05894577|143183249|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.7|1.31|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.31|0.70|
71757389|NCT00554216|143018214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|2.8|5.63||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||5.63|2.80|<0.0001
71757390|NCT00554216|143018214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|STANDARD_ERROR_OF_MEAN|0.394|<|0.0001|TWO_SIDED|95.0|1.76|3.33||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.33|1.76|<0.0001
71757391|NCT03077412|143018242|SUPERIORITY||Risk Difference in Percentages|22.1|||||TWO_SIDED|90.0|-9.9|50.0|||||The 90% exact confidence interval (CI) was calculated based on binomial distribution (Clopper-Pearson method).|||50.0|-9.9|
71757392|NCT03077412|143018242|SUPERIORITY||Risk Difference in Percentages|4.2|||||TWO_SIDED|90.0|-26.5|34.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||34.3|-26.5|
71757393|NCT03077412|143018243|SUPERIORITY||Risk Difference in Percentages|30.4|||||TWO_SIDED|90.0|-1.3|57.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||57.3|-1.3|
71671652|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-2.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).||3|-2|
71671653|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||TWO_SIDED|95.0|-8.0|1.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||1|-8|
71671654|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-4.0|||||TWO_SIDED|95.0|-9.0|0.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||0|-9|
71671655|NCT00450437|142861218|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-5.0|3.0|||ANOVA|||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).||3|-5|
71671656|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
71671657|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|5.0|||||TWO_SIDED|95.0|1.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||9|1|
71671658|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|11.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.||20|11|
71837994|NCT05894577|143183249|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.72|1.4|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.40|0.72|
71671659|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is \> -10%.|Vaccine group difference|23.0|||||TWO_SIDED|95.0|19.0|28.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||28|19|
71671660|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|4.0|||||TWO_SIDED|95.0|0.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||8|0|
71671661|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|0.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||7|0|
71837995|NCT05894577|143183249|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.55|1.2|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.20|0.55|
71671662|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|4.0|9.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||9|4|
71757394|NCT03077412|143018243|SUPERIORITY||Risk Difference in Percentages|8.3|||||TWO_SIDED|90.0|-22.5|38.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||38.1|-22.5|
71757395|NCT03077412|143018244|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|90.0|0.64|2.49|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.49|0.64|
71757396|NCT03077412|143018244|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|90.0|0.47|1.75|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||1.75|0.47|
71757397|NCT03077412|143018245|SUPERIORITY||Hazard Ratio (HR)|1.87|||||TWO_SIDED|90.0|0.87|4.01|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||4.01|0.87|
71757398|NCT03077412|143018245|SUPERIORITY||Hazard Ratio (HR)|1.37|||||TWO_SIDED|90.0|0.65|2.92|||||Hazard ratio was derived from Cox Proportional-Hazards model.|||2.92|0.65|
71757399|NCT03077412|143018246|SUPERIORITY||Risk Difference in Percentages|-18.6|||||TWO_SIDED|90.0|-55.6|21.3|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||21.3|-55.6|
71757400|NCT03077412|143018246|SUPERIORITY||Risk Difference in Percentages|-13.2|||||TWO_SIDED|90.0|-51.0|24.1|||||The 90% exact CI was calculated based on binomial distribution (Clopper-Pearson method).|||24.1|-51.0|
71757401|NCT02266888|143018247|SUPERIORITY||Hazard Ratio (HR)|0.673||||0.514|TWO_SIDED|90.0|0.248|1.826|||Regression, Cox||Hazard ratio estimated for Rituximab vs. Placebo|||1.826|0.248|0.514
71757402|NCT02266888|143018251|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71757403|NCT02266888|143018252|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71757404|NCT02266888|143018253|SUPERIORITY|||||||0.188|||||||Fisher Exact|||||||0.188
71757405|NCT02266888|143018256|SUPERIORITY||Mean Difference (Net)|-1.62||||0.015|TWO_SIDED|90.0|-2.64|-0.6|||Paired t-Test|||This is not a comparison between treatment groups, but rather a comparison between timepoints.The Rituximab and Placebo groups were combined for purposes of testing the hypothesis that there would be no change in SD between pre-enrollment and 180 days post-enrollment into the TVI.||-0.60|-2.64|0.015
71757406|NCT02266888|143018258|SUPERIORITY|||||||0.502|||||||Cochran-Mantel-Haenszel|||||||0.502
71757407|NCT02266888|143018259|SUPERIORITY|||||||0.448|||||||Fisher Exact|||||||0.448
71757408|NCT00918255|143018276|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.022
71757409|NCT00918255|143018276|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.025
71757410|NCT00918255|143018276|SUPERIORITY_OR_OTHER|||||||0.252||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.252
71837996|NCT05894577|143183249|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.62|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.39|0.62|
71757411|NCT00918255|143018277|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|ANCOVA|||||||0.062
71757412|NCT00918255|143018277|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.019
71757413|NCT00918255|143018277|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).||||||0.286
71757414|NCT00918255|143018278|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
71757415|NCT00918255|143018278|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
71757416|NCT00918255|143018278|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.097
71757417|NCT00918255|143018279|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.044
71757418|NCT00918255|143018279|SUPERIORITY_OR_OTHER|||||||0.051||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.051
71757419|NCT00918255|143018279|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.320
71757420|NCT00918255|143018280|SUPERIORITY_OR_OTHER|||||||1||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||1.000
71757421|NCT00918255|143018280|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||1.000
71757422|NCT00918255|143018280|SUPERIORITY_OR_OTHER|||||||0.673||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.673
71757423|NCT00918255|143018281|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel|||||||0.012
71837997|NCT05894577|143183249|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.65|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.65|
71757424|NCT00918255|143018281|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.020
71757425|NCT00918255|143018281|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.||||||0.721
71671663|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is \> -10%.|Vaccine group difference|15.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||20|12|
71757426|NCT00918255|143018282|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Van Elteren test|||||||0.045
71757427|NCT00918255|143018282|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.014
71757428|NCT00918255|143018282|SUPERIORITY_OR_OTHER|||||||0.169||95.0|||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.||||||0.169
71757429|NCT01193244|143018285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.707|||<|1e-05||95.0|0.626|0.799|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.||0.799|0.626|<0.00001
71757430|NCT01193244|143018286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.963||||0.59755||95.0|0.838|1.107|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio \<1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.107|0.838|0.59755
71789389|NCT03720470|143076709|SUPERIORITY||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.5|30.7|||Cochran-Mantel-Haenszel|||Week 2: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.7|13.5|<0.0001
71789390|NCT03720470|143076710|OTHER||Difference in Percentage|22.1|||<|0.0001|TWO_SIDED|95.0|13.7|30.5|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||30.5|13.7|<0.0001
71789391|NCT03720470|143076710|OTHER||Difference in Percentage|35.0|||<|0.0001|TWO_SIDED|95.0|26.3|43.7|||Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||43.7|26.3|<0.0001
71789392|NCT03720470|143076710|OTHER||Difference in Percentage|-3.5|||||TWO_SIDED|95.0|-12.2|5.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||5.2|-12.2|
71789393|NCT03720470|143076710|OTHER||Difference in Percentage|9.4|||||TWO_SIDED|95.0|0.4|18.5||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||18.5|0.4|
71837998|NCT05894577|143183249|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.48|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.48|
71757431|NCT01193244|143018287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|||<|0.001||95.0|1.724|2.721|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline Eastern Cooperative Oncology Group (ECOG) score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio greater than (\>)1 favored orteronel. P-values tested for odds ratio equal to 1.||2.721|1.724|<0.001
71789394|NCT03720470|143076711|OTHER||Difference in percentage|24.1|||<|0.0001|TWO_SIDED|95.0|14.0|34.1|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||34.1|14.0|<0.0001
71789395|NCT03720470|143076711|OTHER||Difference in Percentage|30.1|||<|0.0001|TWO_SIDED|95.0|20.3|39.8|||Cochran-Mantel-Haenszel|||Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||39.8|20.3|<0.0001
71789396|NCT03720470|143076711|OTHER||Difference in Percentage|-2.7|||||TWO_SIDED|95.0|-9.6|4.2||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||4.2|-9.6|
71671664|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|3.0|||||TWO_SIDED|95.0|-1.0|7.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||7|-1|
71757432|NCT01193244|143018288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.712||||0.001||95.0|1.235|2.373|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline ECOG score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio \> 1 favored orteronel. P-values tested for odds ratio equal to 1.||2.373|1.235|0.001
71757433|NCT01193244|143018289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.885||||0.33906||95.0|0.688|1.138|||Log Rank|||Hazard ratio is based on a stratified Cox's proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (\<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.||1.138|0.688|0.33906
71757434|NCT03763877|143018315|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|7.926||0.9883|TWO_SIDED|95.0|-15.42|15.66|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||15.66|-15.42|0.9883
71757435|NCT03763877|143018315|SUPERIORITY||Mean Difference (Final Values)|-13.14|STANDARD_ERROR_OF_MEAN|7.609||0.0842|TWO_SIDED|95.0|-28.06|1.78|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.78|-28.06|0.0842
71757436|NCT03763877|143018315|SUPERIORITY||Mean Difference (Final Values)|-13.54|STANDARD_ERROR_OF_MEAN|7.636||0.0763|TWO_SIDED|95.0|-28.51|1.43|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.43|-28.51|0.0763
71757437|NCT03763877|143018316|SUPERIORITY||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|7.265||0.8283|TWO_SIDED|95.0|-16.01|12.85|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||12.85|-16.01|0.8283
71757438|NCT03763877|143018316|SUPERIORITY||Mean Difference (Final Values)|-13.25|STANDARD_ERROR_OF_MEAN|7.221||0.0698|TWO_SIDED|95.0|-27.6|1.1|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||1.10|-27.60|0.0698
71757439|NCT03763877|143018316|SUPERIORITY||Mean Difference (Final Values)|-17.31|STANDARD_ERROR_OF_MEAN|7.207||0.0184|TWO_SIDED|95.0|-31.63|-2.99|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||-2.99|-31.63|0.0184
71757440|NCT03763877|143018317|SUPERIORITY||Location Shift|-4.22||||0.5537|TWO_SIDED|95.0|-15.64|8.65|||Wilcoxon (Mann-Whitney)|||||8.65|-15.64|0.5537
71757441|NCT03763877|143018317|SUPERIORITY||Location Shift|-13.64||||0.1005|TWO_SIDED|95.0|-26.19|1.88|||Wilcoxon (Mann-Whitney)|||||1.88|-26.19|0.1005
71757442|NCT03763877|143018317|SUPERIORITY||Location Shift|-18.72||||0.0387|TWO_SIDED|95.0|-31.95|-1.58|||Wilcoxon (Mann-Whitney)|||||-1.58|-31.95|0.0387
71789397|NCT03720470|143076711|OTHER||Difference in Percentage|3.1|||||TWO_SIDED|95.0|-3.3|9.6||||||Week 16: Difference in percentage (PF-04965842 versus dupilumab) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity.||9.6|-3.3|
71789398|NCT02772081|143076758|SUPERIORITY||Adjusted difference|-15.4||||0.39|TWO_SIDED|95.0|-47.9|17.1|||Cochran-Mantel-Haenszel|||First Administration; Treatment comparison. Adjusted difference, its 95% confidence interval (CI) and p-value are estimated using Cochran-Mantel-Haenszel test||17.1|-47.9|0.390
71837999|NCT05894577|143183250|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.62|1.24|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.24|0.62|
71757443|NCT03763877|143018318|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|0.5733||0.5733|TWO_SIDED|95.0|-18.0|32.51|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||32.51|-18.00|0.5733
71757444|NCT03763877|143018318|SUPERIORITY||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|12.236||0.3861|TWO_SIDED|95.0|-34.6|13.38|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||13.38|-34.60|0.3861
71757445|NCT03763877|143018318|SUPERIORITY||Mean Difference (Final Values)|-21.13|STANDARD_ERROR_OF_MEAN|12.916||0.1019|TWO_SIDED|95.0|-46.46|4.19|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||4.19|-46.46|0.1019
71757446|NCT03763877|143018319|SUPERIORITY||Mean Difference (Final Values)|-0.242|STANDARD_ERROR_OF_MEAN|1.3873||0.8617|TWO_SIDED|95.0|-2.961|2.478|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||2.478|-2.961|0.8617
71757447|NCT03763877|143018319|SUPERIORITY||Mean Difference (Final Values)|-2.571|STANDARD_ERROR_OF_MEAN|1.3712||0.0609|TWO_SIDED|95.0|-5.26|0.117|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method|||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|0.117|-5.260|0.0609
71789399|NCT02772081|143076764|SUPERIORITY||Median Difference (Final Values)|5.0||||0.563|TWO_SIDED|95.0|-13.8|23.8|||Wilcoxon (Mann-Whitney)|||Duration of standalone oxygen supplementation||23.8|-13.8|0.563
71789400|NCT02772081|143076764|SUPERIORITY||Median Difference (Final Values)|1.0||||0.612|TWO_SIDED|95.0|-19.7|21.7|||Wilcoxon (Mann-Whitney)|||Duration of NIV||21.7|-19.7|0.612
71671665|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|1.0|||||TWO_SIDED|95.0|-1.0|4.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.||4|-1|
71671666|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|6.0|||||TWO_SIDED|95.0|3.0|8.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||8|3|
71757448|NCT03763877|143018319|SUPERIORITY||Mean Difference (Final Values)|-2.414|STANDARD_ERROR_OF_MEAN|1.3633||0.0766|TWO_SIDED|95.0|-5.087|0.258|||ANCOVA|ANCOVA using a multiple imputation procedure based on the fully conditional specification method|Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.258|-5.087|0.0766
71757449|NCT03763877|143018320|SUPERIORITY||Odds Ratio (OR)|1.744||||0.5592|TWO_SIDED|95.0|0.27|11.267|||Regression, Logistic|Logistic regression with multiple imputation||||11.267|0.270|0.5592
71671667|NCT00450437|142861219|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is \> -10%.|Vaccine group difference|12.0|||||TWO_SIDED|95.0|9.0|16.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||16|9|
71757450|NCT03763877|143018320|SUPERIORITY||Odds Ratio (OR)|2.287||||0.3747|TWO_SIDED|95.0|0.368|14.208|||Regression, Logistic|Logistic regression with multiple imputation||||14.208|0.368|0.3747
71757451|NCT03763877|143018320|SUPERIORITY||Odds Ratio (OR)|5.669||||0.0501|TWO_SIDED|95.0|1.0|32.149|||Regression, Logistic|Logistic regression with multiple imputation||||32.149|1.000|0.0501
71757452|NCT03763877|143018321|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|3.71||0.8013|TWO_SIDED|95.0|-8.3|6.4|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.4|-8.3|0.8013
71757453|NCT03763877|143018321|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|3.81||0.8694|TWO_SIDED|95.0|-8.2|7.0|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|7.0|-8.2|0.8694
71757454|NCT03763877|143018321|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|3.8||0.0581|TWO_SIDED|95.0|-14.9|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures|||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|0.3|-14.9|0.0581
71757455|NCT03763877|143018322|SUPERIORITY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|2.44||0.6681|TWO_SIDED|95.0|-3.8|5.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-3.8|0.6681
71757456|NCT03763877|143018322|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|2.51||0.8224|TWO_SIDED|95.0|-4.4|5.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.5|-4.4|0.8224
71757457|NCT03763877|143018322|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|2.5||0.0924|TWO_SIDED|95.0|-9.2|0.7|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7|-9.2|0.0924
71757458|NCT03763877|143018323|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.256||0.5148|TWO_SIDED|95.0|-0.68|0.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.34|-0.68|0.5148
71757459|NCT03763877|143018323|SUPERIORITY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.261||0.0434|TWO_SIDED|95.0|-1.05|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.02|-1.05|0.0434
71757460|NCT03763877|143018323|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.261||0.0494|TWO_SIDED|95.0|-1.04|0.0|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.00|-1.04|0.0494
71757461|NCT03763877|143018324|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.111||0.2449|TWO_SIDED|95.0|-0.35|0.09|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.09|-0.35|0.2449
71757462|NCT03763877|143018324|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.115||0.0502|TWO_SIDED|95.0|-0.46|0.0|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.00|-0.46|0.0502
71789401|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|-0.619||||0.137|TWO_SIDED|95.0|-1.447|0.21|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an mixed model for repeated measures (MMRM) with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.210|-1.447|0.137
71757463|NCT03763877|143018324|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.113||0.0123|TWO_SIDED|95.0|-0.51|-0.06|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.06|-0.51|0.0123
71757464|NCT03763877|143018325|SUPERIORITY||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.2172||0.251|TWO_SIDED|95.0|-0.682|0.18|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.180|-0.682|0.2510
71757465|NCT03763877|143018325|SUPERIORITY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.2202||0.8246|TWO_SIDED|95.0|-0.486|0.388|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.388|-0.486|0.8246
71757466|NCT03763877|143018325|SUPERIORITY||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.2216||0.9067|TWO_SIDED|95.0|-0.466|0.414|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.414|-0.466|0.9067
71757467|NCT03763877|143018326|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.0468||0.6951|TWO_SIDED|95.0|-0.111|0.075|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.075|-0.111|0.6951
71757468|NCT03763877|143018326|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.0472||0.103|TWO_SIDED|95.0|-0.171|0.016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.016|-0.171|0.1030
71757469|NCT03763877|143018326|SUPERIORITY||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.0471||0.8583|TWO_SIDED|95.0|-0.085|0.102|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.102|-0.085|0.8583
71757470|NCT03763877|143018327|SUPERIORITY||Mean Difference (Final Values)|-0.105|STANDARD_ERROR_OF_MEAN|0.1777||0.5576|TWO_SIDED|95.0|-0.457|0.248|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.248|-0.457|0.5576
71757471|NCT03763877|143018327|SUPERIORITY||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.1799||0.4261|TWO_SIDED|95.0|-0.213|0.501|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.501|-0.213|0.4261
71757472|NCT03763877|143018327|SUPERIORITY||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.1822||0.6571|TWO_SIDED|95.0|-0.281|0.443|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.443|-0.281|0.6571
71757473|NCT03763877|143018328|SUPERIORITY||Mean Difference (Final Values)|-0.161|STANDARD_ERROR_OF_MEAN|0.2851||0.5732|TWO_SIDED|95.0|-0.727|0.405|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.405|-0.727|0.5732
71757474|NCT03763877|143018328|SUPERIORITY||Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.2884||0.6312|TWO_SIDED|95.0|-0.712|0.434|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.434|-0.712|0.6312
71757475|NCT03763877|143018328|SUPERIORITY||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.2865||0.4857|TWO_SIDED|95.0|-0.769|0.368|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.368|-0.769|0.4857
71757476|NCT03763877|143018329|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.074||0.5737|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.19|-0.11|0.5737
71789402|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.268||||0.534|TWO_SIDED|95.0|-0.604|1.14|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.140|-0.604|0.534
71789403|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.27||||0.53|TWO_SIDED|95.0|-0.597|1.136|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.136|-0.597|0.530
71677211|NCT04143594|142873010|SUPERIORITY||Difference in LSM|-0.01||||0.9555|TWO_SIDED|95.0|-0.28|0.26||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.26|-0.28|0.9555
71757477|NCT03763877|143018329|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.074||0.7563|TWO_SIDED|95.0|-0.12|0.17|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.17|-0.12|0.7563
71757478|NCT03763877|143018329|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.075||0.5695|TWO_SIDED|95.0|-0.19|0.11|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANCOVA model.|||0.11|-0.19|0.5695
71757479|NCT03763877|143018330|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.659||0.9552|TWO_SIDED|95.0|-1.34|1.27|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.27|-1.34|0.9552
71757480|NCT03763877|143018330|SUPERIORITY||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.674||0.2633|TWO_SIDED|95.0|-2.1|0.58|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.58|-2.10|0.2633
71757481|NCT03763877|143018330|SUPERIORITY||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.673||0.1962|TWO_SIDED|95.0|-2.21|0.46|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.46|-2.21|0.1962
71757482|NCT03763877|143018331|SUPERIORITY||Odds Ratio (OR)|1.353||||0.8245|TWO_SIDED|95.0|0.094|19.554|||Regression, Logistic|||||19.554|0.094|0.8245
71757483|NCT03763877|143018331|SUPERIORITY||Odds Ratio (OR)|2.791||||0.414|TWO_SIDED|95.0|0.238|32.752|||Regression, Logistic|||||32.752|0.238|0.4140
71757484|NCT03763877|143018331|SUPERIORITY||Odds Ratio (OR)|14.872||||0.0341|TWO_SIDED|95.0|1.226|180.452|||Regression, Logistic|||||180.452|1.226|0.0341
71757485|NCT03763877|143018332|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.84||0.4626|TWO_SIDED|95.0|-16.1|7.5|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.5|-16.1|0.4626
71757486|NCT03763877|143018332|SUPERIORITY||Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|5.88||0.316|TWO_SIDED|95.0|-17.9|5.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.9|-17.9|0.3160
71757487|NCT03763877|143018332|SUPERIORITY||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|6.19||0.0204|TWO_SIDED|95.0|-27.4|-2.4|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-2.4|-27.4|0.0204
71757488|NCT03763877|143018333|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|3.91||0.4601|TWO_SIDED|95.0|-10.8|5.0|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||5.0|-10.8|0.4601
71892438|NCT01381094|143306463|SUPERIORITY||||||=|0.0448|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0448
71757489|NCT03763877|143018333|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.95||0.9782|TWO_SIDED|95.0|-8.1|7.9|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.9|-8.1|0.9782
71757490|NCT03763877|143018333|SUPERIORITY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.13||0.0205|TWO_SIDED|95.0|-18.3|-1.6|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.6|-18.3|0.0205
71789404|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.641||||0.091|TWO_SIDED|95.0|-0.108|1.389|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||1.389|-0.108|0.091
71757491|NCT03763877|143018334|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.538||0.9529|TWO_SIDED|95.0|-1.12|1.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.05|-1.12|0.9529
71757492|NCT03763877|143018334|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.532||0.1285|TWO_SIDED|95.0|-1.9|0.25|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.25|-1.90|0.1285
71757493|NCT03763877|143018334|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.565||0.0417|TWO_SIDED|95.0|-2.32|-0.05|||Mixed Models Analysis||Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.05|-2.32|0.0417
71757494|NCT03763877|143018335|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3141|TWO_SIDED|95.0|-0.69|0.23|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.23|-0.69|0.3141
71789405|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.463||||0.04|TWO_SIDED|95.0|0.023|0.903|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.903|0.023|0.040
71789406|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.166||||0.532|TWO_SIDED|95.0|-0.371|0.703|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.703|-0.371|0.532
71789407|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.048||||0.877|TWO_SIDED|95.0|-0.578|0.674|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.674|-0.578|0.877
71789408|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.244||||0.356|TWO_SIDED|95.0|-0.289|0.776|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.776|-0.289|0.356
71789409|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.303||||0.258|TWO_SIDED|95.0|-0.235|0.841|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.841|-0.235|0.258
71789410|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|0.022||||0.945|TWO_SIDED|95.0|-0.616|0.66|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.660|-0.616|0.945
71757495|NCT03763877|143018335|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0656|TWO_SIDED|95.0|-0.88|0.03|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||0.03|-0.88|0.0656
71757496|NCT03763877|143018335|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.237||0.0101|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Mean difference (final values) is the difference in LS Means estimated in the ANOVA model.|||-0.16|-1.12|0.0101
71757497|NCT03537404|143018350|OTHER||Geometric Mean Ratio|0.02|||||TWO_SIDED|90.0|-0.103|0.142|||||Cmax parameters were logarithmically transformed|||0.142|-0.103|
71757498|NCT03537404|143018350|OTHER||Geometric Mean Ratio|-0.022|||||TWO_SIDED|90.0|-0.22|0.175|||||Cmax parameters were logarithmically transformed|||0.175|-0.220|
71757499|NCT03537404|143018351|OTHER||Geometric Mean Ratio|0.041|||||TWO_SIDED|90.0|-0.075|0.157|||||AUCtau parameters were logarithmically transformed.|||0.157|-0.075|
71757500|NCT03537404|143018351|OTHER||Geometric Mean Ratio|-0.069|||||TWO_SIDED|90.0|-0.201|0.064|||||AUCtau parameters were logarithmically transformed|||0.064|-0.201|
71757501|NCT03537404|143018352|OTHER||Geometric Mean Ratio|0.271|||||TWO_SIDED|90.0|0.159|0.383|||||Cmax parameters were logarithmically transformed|||0.383|0.159|
71757502|NCT03537404|143018353|OTHER||Geometric Mean Ratio|0.074|||||TWO_SIDED|90.0|0.016|0.132|||||AUCtau parameters were logarithmically transformed|||0.132|0.016|
71757503|NCT03537404|143018354|OTHER||Geometric Mean Ratio|-0.148|||||TWO_SIDED|90.0|-0.45|0.153|||||Cmax parameters were logarithmically transformed|||0.153|-0.450|
71757504|NCT03537404|143018355|OTHER||Geometric Mean Ratio|-0.093|||||TWO_SIDED|90.0|-0.354|0.168|||||AUCtau parameters were logarithmically transformed|||0.168|-0.354|
71757505|NCT00068692|143018361|SUPERIORITY|||||||0.35||||||One-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration||||||0.35
71757506|NCT00068692|143018361|SUPERIORITY|||||||0.69||||||one-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration||||||0.69
71789411|NCT02772081|143076767|SUPERIORITY||Adjusted mean difference|-0.075||||0.766|TWO_SIDED|95.0|-0.586|0.436|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2/FiO2 as a covariate.||0.436|-0.586|0.766
71671668|NCT00450437|142861220|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.|hSBA GMT ratios|1.32|||||TWO_SIDED|95.0|1.12|1.56|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5."||1.56|1.12|
71838000|NCT05894577|143183250|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.38|0.65|
71838001|NCT05894577|143183250|OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.13|0.49|
71838002|NCT05894577|143183250|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.67|1.55|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.55|0.67|
71838003|NCT05894577|143183250|OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.19|0.51|
71838004|NCT05894577|143183250|OTHER||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.49|1.35|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.35|0.49|
71838005|NCT05894577|143183251|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.41|0.77|
71838006|NCT05894577|143183251|OTHER||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.82|1.69|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.69|0.82|
71838007|NCT05894577|143183251|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.52|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.14|0.52|
71838008|NCT05894577|143183251|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.65|1.43|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.43|0.65|
71892439|NCT01381094|143306463|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
71671669|NCT00450437|142861220|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.|hSBA GMT ratios|1.4|||||TWO_SIDED|95.0|1.17|1.67|||ANOVA|||"Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5."||1.67|1.17|
71757507|NCT00248040|143018382|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.275||||0.9076|TWO_SIDED|95.0|-5.0|4.45|||Other|||This analysis refers to the 1-3 hours time point||4.45|-5.00|0.9076
71838009|NCT05894577|143183251|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.41|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.41|0.63|
71838010|NCT05894577|143183251|OTHER||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.44|1.19|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.19|0.44|
71838011|NCT05894577|143183252|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.39|0.75|
71838012|NCT05894577|143183252|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.76|1.44|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.44|0.76|
71892440|NCT01381094|143306463|SUPERIORITY||||||=|0.0813|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0813
71838013|NCT05894577|143183252|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.84|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.71|0.84|
71838014|NCT05894577|143183252|OTHER||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.76|1.71|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.71|0.76|
71838015|NCT05894577|143183252|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.67|1.46|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.46|0.67|
71838016|NCT05894577|143183252|OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.59|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.59|0.62|
71757508|NCT00248040|143018382|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|2.444||||0.3084|TWO_SIDED|95.0|-2.32|7.21|||Other|||This analysis refers to the 1-3 hours timepoint.||7.21|-2.32|0.3084
71757509|NCT00248040|143018382|OTHER||Difference between means|-2.719||||0.2565|TWO_SIDED|95.0|-7.47|2.03|||Other|||||2.03|-7.47|0.2565
71757510|NCT00248040|143018382|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.063||||0.9855|TWO_SIDED|95.0|-6.91|6.79|||Other|||This analysis refers to the 10-12 hours time point.||6.79|-6.91|0.9855
71757511|NCT00248040|143018382|SUPERIORITY|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|4.519||||0.1934|TWO_SIDED|95.0|-2.36|11.39|||Other|||This analysis refers to the 10-12 hours timepoint.||11.39|-2.36|0.1934
71757512|NCT00248040|143018382|OTHER|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-4.582||||0.1797|TWO_SIDED|95.0|-11.3|2.17|||Other|||This analysis refers to the 10-12 hours time point.||2.17|-11.3|0.1797
71757513|NCT02930824|143018411|SUPERIORITY|We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||||0.78||||||Analysis was done of adult patients enrolled that have a CYP2C19 Rapid or Ultra-rapid metabolizer result.|t-test, 2 sided|||We will test the hypothesis that CYP2C19 rapid metabolizers or ultra rapid metabolizers (1 or 2 gain-of-function alleles) in the genotype-supported arm have better gastroesophageal reflux disease and symptom control than CYP2C19 rapid metabolizers or ultra rapid metabolizers in the conventional treatment group because they will have their dose increased based on their genotype.||||0.78
71757514|NCT02930824|143018412|SUPERIORITY|||||||0.031||||||Adjusted for baseline score, race, baseline proton pump inhibitor use, baseline histamine receptor antagonist use. A sensitivity analysis of participants only on omeprazole revealed similar findings.|Wilcoxon (Mann-Whitney)|Adjusted these end points for covariates, including the baseline score, race, and baseline medications using logistic regression||||||0.031
71757515|NCT02930824|143018413|SUPERIORITY||Hazard Ratio (HR)|2.42||||0.07|TWO_SIDED|95.0|0.9|6.3||unadjusted|Log Rank|||||6.3|0.9|0.07
71757516|NCT02930824|143018414|SUPERIORITY|||||||0.97||||||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.|Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.97
71757517|NCT02930824|143018415|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||If a participant did not complete a follow-up questionnaire during their third to fifth week of proton pump inhibitor therapy, their questionnaire results were excluded from the analyses.||||0.83
71757518|NCT02540629|143018416|EQUIVALENCE|Chi-squared test||||||0.01|||||||Chi-squared|||||||0.01
71757519|NCT01524796|143018451|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||paired Wilcoxon signed-rank test|||||||<0.001
71757520|NCT01524796|143018452|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
71838017|NCT05894577|143183253|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.74|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 7||1.14|0.74|
71838018|NCT05894577|143183253|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.79|1.22|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 14||1.22|0.79|
71838019|NCT05894577|143183253|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.71|1.08|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 28||1.08|0.71|
71838020|NCT05894577|143183253|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.8|1.21|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 90||1.21|0.80|
71838021|NCT05894577|143183253|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.84|1.29|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 120||1.29|0.84|
71838022|NCT05894577|143183253|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.68|1.14|||||Initially estimated on the log relative odds scale, and then transformed to the odds ratio scale. On the log relative odds scale, the estimated parameter value was the posterior mean. Interval estimate is highest density Bayesian credible interval.|Day 180||1.14|0.68|
71838023|NCT05894577|143183254|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|-0.24|||||TWO_SIDED|95.0|-0.6|0.1|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.1|-0.6|
71838024|NCT05894577|143183255|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimated means|0.31|||||TWO_SIDED|95.0|-0.13|0.75|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.75|-0.13|
71838025|NCT04509674|143183274|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.2061|TWO_SIDED|95.0|0.76|1.06||"Null hypothesis: there is no difference regarding the risk of the endpoint in question between empagliflozin and placebo.~p\<=0.05 required for testing of subsequent key secondary endpoint hypotheses"|Regression, Cox||Empagliflozin vs. Placebo|The primary endpoint was analysed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.||1.06|0.76|0.2061
71838026|NCT04509674|143183275|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.2423|TWO_SIDED|95.0|0.68|1.1|||Negative binomial regression||Empagliflozin vs. Placebo|||1.10|0.68|0.2423
71838027|NCT04509674|143183276|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.92||||0.2867|TWO_SIDED|95.0|0.78|1.07|||Negative binomial regression||Empagliflozin vs. Placebo|||1.07|0.78|0.2867
71838028|NCT04509674|143183277|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|0.87||||0.0463|TWO_SIDED|95.0|0.7654|0.9978|||Negative binomial regression||Empagliflozin vs. Placebo|||0.9978|0.7654|0.0463
71838029|NCT04509674|143183278|OTHER|The statistical model used was a negative binomial model, including factors for treatment and type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates. The log(observation time) was used as an offset variable.|Adjusted event rate ratio|1.06||||0.6311|TWO_SIDED|95.0|0.83|1.35|||Negative binomial regression||Empagliflozin vs. Placebo|||1.35|0.83|0.6311
71677212|NCT04143594|142873010|SUPERIORITY||Difference in LSM|0.14||||0.4025|TWO_SIDED|95.0|-0.19|0.46||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||0.46|-0.19|0.4025
71757521|NCT01524796|143018453|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon signed-rank test|||||||<0.001
71757522|NCT01002339|143018469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||||||0.02
71757523|NCT01002339|143018470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Chi-squared|||||||0.06
71757524|NCT01002339|143018471|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
71838030|NCT04509674|143183279|OTHER|The statistical analysis was performed using a Cox proportional hazards model with treatment, type-2 diabetes at baseline, geographical region, age at baseline, estimated glomerular filtration rate at baseline, left ventricular ejection fraction at baseline, persistent or permanent atrial fibrillation at baseline, prior myocardial infarction at baseline, peripheral artery disease at baseline and smoking at baseline as covariates.|Hazard Ratio (HR)|1.03||||0.8124||95.0|0.81|1.31|||Regression, Cox||Empagliflozin vs. Placebo|||1.31|0.81|0.8124
71892441|NCT01381094|143306463|SUPERIORITY||||||=|0.0038|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0038
71671670|NCT00450437|142861220|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.|hSBA GMT ratios|1.76|||||TWO_SIDED|95.0|1.51|2.05|||ANOVA|||"Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5."||2.05|1.51|
71892442|NCT01381094|143306463|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6861
71671671|NCT00450437|142861220|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.|hSBA GMT ratios|2.49|||||TWO_SIDED|95.0|2.11|2.95|||ANOVA|||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5."||2.95|2.11|
71757525|NCT01002339|143018472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Chi-squared|||||||0.07
71757526|NCT01002339|143018473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|||||||ANOVA|||||||0.2
71757527|NCT01002339|143018474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||ANOVA|||||||0.4
71757528|NCT01002339|143018475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||ANOVA|||||||0.8
71757529|NCT01002339|143018476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||ANOVA|||||||0.56
71757530|NCT01002339|143018477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Kruskal-Wallis|||||||0.8
71789412|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|0.051||||0.59|TWO_SIDED|95.0|-0.141|0.243|||Mixed model for repeated measures|||T0, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.243|-0.141|0.590
71757531|NCT01002339|143018478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||ANOVA|||||||0.66
71789413|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.051||||0.511|TWO_SIDED|95.0|-0.21|0.107|||Mixed model for repeated measures|||5 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.107|-0.210|0.511
71789414|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.05||||0.488|TWO_SIDED|95.0|-0.196|0.096|||Mixed model for repeated measures|||15 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.096|-0.196|0.488
71757532|NCT01002339|143018479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|||||||ANOVA|||||||0.37
71757533|NCT01002339|143018480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||||||0.45
71757534|NCT01002339|143018481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.50
71757535|NCT01002339|143018482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||Chi-squared|||||||0.17
71789415|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.11||||0.091|TWO_SIDED|95.0|-0.239|0.019|||Mixed model for repeated measures|||30 min, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.019|-0.239|0.091
71789416|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.024||||0.344|TWO_SIDED|95.0|-0.076|0.027|||Mixed model for repeated measures|||1 hour, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.027|-0.076|0.344
71789417|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.026||||0.376|TWO_SIDED|95.0|-0.084|0.033|||Mixed model for repeated measures|||6 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.033|-0.084|0.376
71789418|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.04||||0.396|TWO_SIDED|95.0|-0.135|0.055|||Mixed model for repeated measures|||12 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.135|0.396
71789419|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.026||||0.268|TWO_SIDED|95.0|-0.074|0.021|||Mixed model for repeated measures|||24 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.021|-0.074|0.268
71789420|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.037||||0.147|TWO_SIDED|95.0|-0.089|0.014|||Mixed model for repeated measures|||48 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.014|-0.089|0.147
71789421|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.055|0.055|||Mixed model for repeated measures|||72 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.055|-0.055|0.994
71789422|NCT02772081|143076768|SUPERIORITY||Adjusted mean difference|-0.004||||0.853|TWO_SIDED|95.0|-0.048|0.04|||Mixed model for repeated measures|||120 hours, Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure FiO2 as a covariate.||0.040|-0.048|0.853
71789423|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|-10.4||||0.09|TWO_SIDED|95.0|-22.6|1.7|||Mixed model for repeated measures|||T0; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||1.7|-22.6|0.090
71671672|NCT00450437|142861222|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-7.0|5.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.||5|-7|
71671673|NCT00450437|142861222|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|3.0|15.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.||15|3|
71757536|NCT01002339|143018483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||ANOVA|||||||0.5
71757537|NCT01002339|143018484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Chi-squared|||||||0.9
71757538|NCT02215252|143018485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.355|||TWO_SIDED|90.0|-1.0|0.17||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||0.17|-1.00|
71757539|NCT02215252|143018485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|0.23|||TWO_SIDED|90.0|-0.91|-0.2||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.||-0.20|-0.91|
71757540|NCT02215252|143018486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||||TWO_SIDED|90.0|0.78|4.69||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.69|0.78|
71757541|NCT02215252|143018486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|90.0|1.06|6.56||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||6.56|1.06|
71757542|NCT02215252|143018487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|90.0|0.33|4.74||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||4.74|0.33|
71757543|NCT02215252|143018487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.75|||||TWO_SIDED|90.0|1.43|15.81||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.||15.81|1.43|
71757544|NCT02215252|143018488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-1.75|-0.32||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.32|-1.75|
71671674|NCT00450437|142861222|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|9.0|||||TWO_SIDED|95.0|2.0|17.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.||17|2|
71671675|NCT00450437|142861222|NON_INFERIORITY_OR_EQUIVALENCE|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is \> -10%.|Vaccine group difference|16.0|||||TWO_SIDED|95.0|9.0|23.0|||ANOVA|||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.||23|9|
71757545|NCT02215252|143018488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-1.43|0.04||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.04|-1.43|
71757546|NCT02215252|143018489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-0.86|0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.43|-0.86|
71757547|NCT02215252|143018489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|90.0|-1.33|0.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4||0.00|-1.33|
71757548|NCT02215252|143018490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|90.0|-0.87|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.87|
71757549|NCT02215252|143018490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-1.36|0.2||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.20|-1.36|
71757550|NCT02215252|143018491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.49|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.67|-0.49|
71757551|NCT02215252|143018491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.13||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.13|-1.05|
71757552|NCT02215252|143018492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.09|0.39||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.39|-1.09|
71757553|NCT02215252|143018492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-1.0|0.51||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||0.51|-1.00|
71757554|NCT02215252|143018493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|2.92|||TWO_SIDED|90.0|-5.12|4.57||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||4.57|-5.12|
71757555|NCT02215252|143018493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.61|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-10.57|-0.66||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.66|-10.57|
71838031|NCT03721952|143183301|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.13|STANDARD_ERROR_OF_MEAN|0.323||0.688|TWO_SIDED|95.0|-0.505|0.764|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average depression score \& negative sign of estimate defined as higher average depression score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.764|-0.505|0.688
71757556|NCT02215252|143018494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|0.34|1.45||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.45|0.34|
71757557|NCT02215252|143018494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|90.0|0.24|1.07||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.||1.07|0.24|
71757558|NCT02215252|143018495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.16|-0.02||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.02|-1.16|
71757559|NCT02215252|143018495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-1.57|-0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||-0.43|-1.57|
71757560|NCT02215252|143018496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.0|STANDARD_ERROR_OF_MEAN|816.0|||TWO_SIDED|90.0|-1161.0|1544.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1544|-1161|
71757561|NCT02215252|143018496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|611.0|STANDARD_ERROR_OF_MEAN|812.0|||TWO_SIDED|90.0|-735.0|1956.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.||1956|-735|
71757562|NCT02215252|143018500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.99|STANDARD_ERROR_OF_MEAN|3.03|||TWO_SIDED|90.0|2.98|13.01||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||13.01|2.98|
71757563|NCT02215252|143018500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|3.14|||TWO_SIDED|90.0|-4.46|5.95||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||5.95|-4.46|
71757564|NCT02215252|143018501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.55|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|90.0|2.94|20.17||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||20.17|2.94|
71757565|NCT02215252|143018501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-11.38|6.54||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.||6.54|-11.38|
71757566|NCT02633306|143018503|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71757567|NCT02633306|143018504|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71757568|NCT02633306|143018505|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71757569|NCT02633306|143018506|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71789424|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|-0.3||||0.917|TWO_SIDED|95.0|-6.4|5.8|||Mixed model for repeated measures|||5 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.8|-6.4|0.917
71789425|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|-1.5||||0.668|TWO_SIDED|95.0|-8.5|5.6|||Mixed model for repeated measures|||15 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.6|-8.5|0.668
71789426|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|4.0||||0.149|TWO_SIDED|95.0|-1.5|9.6|||Mixed model for repeated measures|||30 min; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||9.6|-1.5|0.149
71677213|NCT04143594|142873011|SUPERIORITY||Difference in LSM|12.0||||0.7751|TWO_SIDED|95.0|-73.0|97.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||97|-73|0.7751
71838032|NCT03721952|143183301|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.510
71838033|NCT03721952|143183302|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.143|STANDARD_ERROR_OF_MEAN|0.323||0.658|TWO_SIDED|95.0|-0.491|0.777|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average anxiety score \& negative sign of estimate defined as higher average anxiety score, over 3 follow-up points for the intervention group vs. the control group.|Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||0.777|-0.491|0.658
71838034|NCT03721952|143183302|SUPERIORITY|||||||0.268|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.268
71838035|NCT03721952|143183303|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.2|STANDARD_ERROR_OF_MEAN|0.077||0.01|TWO_SIDED|95.0|-0.353|-0.048|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score over 3 follow-up points for intervention vs control groups.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||-0.048|-0.353|0.010
71838036|NCT03721952|143183303|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.175
71757570|NCT02633306|143018507|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71838037|NCT03721952|143183304|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.021|STANDARD_ERROR_OF_MEAN|0.092||0.817|TWO_SIDED|95.0|-0.203|0.16|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average quality-of-relationship score \& negative sign of estimate defined as higher average quality-of-relationship score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.160|-0.203|0.817
71838038|NCT03721952|143183304|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.949
71757571|NCT02633306|143018508|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71789427|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|1.8||||0.318|TWO_SIDED|95.0|-1.9|5.5|||Mixed model for repeated measures|||1 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||5.5|-1.9|0.318
71789428|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|1.6||||0.148|TWO_SIDED|95.0|-0.6|3.7|||Wilcoxon (Mann-Whitney)|||6 hour; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.7|-0.6|0.148
71838039|NCT03721952|143183305|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.45|STANDARD_ERROR_OF_MEAN|0.239||0.06|TWO_SIDED|95.0|-0.919|0.02|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional information: Positive sign of estimate defined as lower average preparation score \& negative sign of estimate defined as higher average preparation score, over 3 follow-up points for intervention vs control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.020|-0.919|0.060
71757572|NCT02633306|143018509|OTHER|||||||||||||||||In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|In an exploratory trial with such a small number of participants no statistical analysis beyond descriptive statistics of the findings is appropriate. The descriptive statistics are reported.|||
71757573|NCT00956007|143018510|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0747|TWO_SIDED|95.0|0.6|1.08||One-sided significance level = 0.0183|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|This trial was designed to detect a hazard ratio (HR) of 0.74 with 80% statistical power and overall one-sided alpha of 0.025 (372 deaths) using a stratified log-rank test, assuming a control arm 3-year survival rate of 60.1%. The amended protocol based on ≥ 5 years potential follow-up projected 169 events, providing 55%, 66%, and 79% power to detect HRs of 0.71, 0.68, and 0.64, respectively, using the original one-sided alpha of 0.0183 the final analysis.||1.08|0.60|0.0747
71757574|NCT00956007|143018511|SUPERIORITY|||||||0.0075|||||||Fisher Exact|||Dysphagia||||0.0075
71757575|NCT00956007|143018511|SUPERIORITY|||||||0.2955|||||||Fisher Exact|||Dry mouth||||0.2955
71757576|NCT00956007|143018511|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||Dermatitis radiation||||0.0001
71757577|NCT00956007|143018511|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Rach acneiform||||<0.0001
71757578|NCT00956007|143018512|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71757579|NCT00956007|143018513|SUPERIORITY|||||||0.1641|||||||Fisher Exact|||Dysphagia||||0.1641
71838040|NCT03721952|143183305|SUPERIORITY|||||||0.701|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.701
71838041|NCT03721952|143183306|SUPERIORITY||Avg. Intervention Effect (CON--INT)|-0.393||||0.053|TWO_SIDED|95.0|-0.791|0.005|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.|Additional estimation information: Positive sign of estimate defined as lower average goal-concordant care \& negative sign of estimate defined as higher average goal-concordant care, over 3 follow-up points for intervention group vs. control group.|Superior outcome for Group 2 (Facilitator-based INTERVENTION: Family)||0.005|-0.791|0.053
71838042|NCT03721952|143183306|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.039
71892443|NCT01381094|143306463|SUPERIORITY||||||=|0.0553|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0553
71892444|NCT01381094|143306463|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0004
71892445|NCT01381094|143306463|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
71671676|NCT03296527|142861229|NON_INFERIORITY|If the lower-limit of the two-sided 95% confidence interval (CI) was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected. In that case, it would be claimed that FE 999049 was non-inferior to GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.|Risk Difference (RD)|5.4|||||TWO_SIDED|95.0|-0.2|11.0|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing pregnancy rate||11.0|-0.2|
71757580|NCT00956007|143018513|SUPERIORITY|||||||0.2623|||||||Fisher Exact|||Dry mouth||||0.2623
71757581|NCT00956007|143018513|SUPERIORITY|||||||0.5378|||||||Fisher Exact|||Dermatitis radiation||||0.5378
71757582|NCT00956007|143018513|SUPERIORITY|||||||0.057|||||||Fisher Exact|||Rash acneiform||||0.0570
71757583|NCT00956007|143018514|SUPERIORITY|||||||0.1575|||||||Fisher Exact|||||||0.1575
71757584|NCT00956007|143018515|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0168|TWO_SIDED|95.0|0.57|0.98||One-sided|Log Rank|Stratified by EGFR and site/p16 status|Stratified by EGFR and site/p16 status. Reference level = IMRT.|||0.98|0.57|0.0168
71757585|NCT01746901|143018521|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|30.5|||<|0.0001|TWO_SIDED|95.0|24.4|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|24.4|<0.0001
71757586|NCT01746901|143018521|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7||||0.0132|TWO_SIDED|95.0|1.6|13.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.7|1.6|0.0132
71757587|NCT01746901|143018521|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
71789429|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|3.3||||0.333|TWO_SIDED|95.0|-3.6|10.2|||Mixed model for repeated measures|||12 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||10.2|-3.6|0.333
71789430|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|0.9||||0.56|TWO_SIDED|95.0|-2.2|4.0|||Mixed model for repeated measures|||24 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.0|-2.2|0.560
71789431|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|2.0||||0.089|TWO_SIDED|95.0|-0.3|4.3|||Mixed model for repeated measures|||48 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.3|-0.3|0.089
71892446|NCT01381094|143306463|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
71892447|NCT01381094|143306463|SUPERIORITY||||||=|0.7379|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.7379
71892448|NCT01381094|143306463|SUPERIORITY||||||=|0.072|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0720
71757588|NCT01746901|143018521|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9|||<|0.0001|TWO_SIDED|95.0|16.8|28.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|16.8|<0.0001
71757589|NCT01746901|143018521|SUPERIORITY_OR_OTHER||LS Mean Difference|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.4|9.3|<0.0001
71757590|NCT01746901|143018521|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||18.5|TWO_SIDED|95.0|12.5|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|12.5|18.5
71757591|NCT01746901|143018522|SUPERIORITY_OR_OTHER||LS Mean Difference|49.3|||<|0.0001|TWO_SIDED|95.0|39.2|59.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.5|39.2|<0.0001
71757592|NCT01746901|143018522|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9994|TWO_SIDED|95.0|-10.1|10.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.1|-10.1|0.9994
71757593|NCT01746901|143018522|SUPERIORITY_OR_OTHER||LS Mean Difference|22.2|||<|0.0001|TWO_SIDED|95.0|12.1|32.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.4|12.1|<0.0001
71757594|NCT01746901|143018522|SUPERIORITY_OR_OTHER||LS Mean Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.0|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|17.0|<0.0001
71757595|NCT01746901|143018522|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0|||<|0.0001|TWO_SIDED|95.0|12.8|33.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.1|12.8|<0.0001
71838043|NCT03721952|143183307|SUPERIORITY||Avg. Intervention Effect (CON--INT)|0.636||||0.239|TWO_SIDED|95.0|-0.425|1.7|||Mixed Models Analysis|Linear mixed-effects: 1-, 3-, 6-mo outcomes, intervention \& time predictors. Primary analysis: avg control-intervention effect over 3 time points.||Superior outcome for Group2 (Facilitator-based INTERVENTION: Family)||1.700|-0.425|0.239
71671677|NCT03296527|142861230|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|0.3|12.3|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with positive beta-hCG||12.3|0.3|
71757596|NCT01746901|143018522|SUPERIORITY_OR_OTHER||LS Mean Difference|18.2||||0.0005|TWO_SIDED|95.0|8.1|28.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.4|8.1|0.0005
71757597|NCT01746901|143018523|SUPERIORITY_OR_OTHER||LS Mean Difference|63.2|||<|0.0001|TWO_SIDED|95.0|51.5|74.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.9|51.5|<0.0001
71757598|NCT01746901|143018523|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0402|TWO_SIDED|95.0|0.6|24.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|0.6|0.0402
71789432|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|1.9||||0.115|TWO_SIDED|95.0|-0.5|4.4|||Mixed model for repeated measures|||72 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||4.4|-0.5|0.115
71789433|NCT02772081|143076769|SUPERIORITY||Adjusted mean difference|1.1||||0.284|TWO_SIDED|95.0|-1.0|3.3|||Mixed model for repeated measures|||120 hours; Treatment comparison. The analysis was based on an MMRM with treatment, timepoint, treatment by timepoint interaction, and GA group as fixed effects and pre-procedure SpO2 as a covariate.||3.3|-1.0|0.284
71757599|NCT01746901|143018523|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|21.1|44.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.7|21.1|<0.0001
71757600|NCT01746901|143018523|SUPERIORITY_OR_OTHER||LS Mean Difference|42.6|||<|0.0001|TWO_SIDED|95.0|30.9|54.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||54.4|30.9|<0.0001
71757601|NCT01746901|143018523|SUPERIORITY_OR_OTHER||LS Mean Difference|32.1|||<|0.0001|TWO_SIDED|95.0|20.3|43.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.9|20.3|<0.0001
71757602|NCT01746901|143018523|SUPERIORITY_OR_OTHER||LS Mean Difference|36.3|||<|0.0001|TWO_SIDED|95.0|24.6|48.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.1|24.6|<0.0001
71757603|NCT01746901|143018524|SUPERIORITY_OR_OTHER||LS Mean Difference|108.0|||<|0.0001|TWO_SIDED|95.0|91.6|124.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.5|91.6|<0.0001
71757604|NCT01746901|143018524|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4125|TWO_SIDED|95.0|-9.6|23.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.3|-9.6|0.4125
71757605|NCT01746901|143018524|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1|||<|0.0001|TWO_SIDED|95.0|29.6|62.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||62.5|29.6|<0.0001
71757606|NCT01746901|143018524|SUPERIORITY_OR_OTHER||LS Mean Difference|68.8|||<|0.0001|TWO_SIDED|95.0|52.4|85.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.2|52.4|<0.0001
71757607|NCT01746901|143018524|SUPERIORITY_OR_OTHER||LS Mean Difference|56.7|||<|0.0001|TWO_SIDED|95.0|40.3|73.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.2|40.3|<0.0001
71757608|NCT01746901|143018524|SUPERIORITY_OR_OTHER||LS Mean Difference|52.6|||<|0.0001|TWO_SIDED|95.0|36.2|69.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||69.0|36.2|<0.0001
71757609|NCT01746901|143018525|SUPERIORITY_OR_OTHER||LS Mean Difference|32.8|||<|0.0001|TWO_SIDED|95.0|21.8|43.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||43.7|21.8|<0.0001
71757610|NCT01746901|143018525|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.6434|TWO_SIDED|95.0|-8.4|13.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.5|-8.4|0.6434
71838044|NCT03721952|143183307|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|Average Intervention effect with time interaction (control-intervention)||||||0.170
71671678|NCT03296527|142861231|OTHER||Risk Difference (RD)|4.9|||||TWO_SIDED|95.0|-0.9|10.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer||10.7|-0.9|
71671679|NCT03296527|142861232|OTHER||Risk Difference (RD)|4.2|||||TWO_SIDED|95.0|-1.5|9.8|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer||9.8|-1.5|
71671680|NCT03296527|142861233|OTHER||Risk Difference (RD)|3.9|||||TWO_SIDED|95.0|-1.6|9.5|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of implanted embryos 5-6 weeks after transfer||9.5|-1.6|
71671681|NCT03296527|142861234|OTHER||Risk Difference (RD)|4.4|||||TWO_SIDED|95.0|-0.9|9.7|||||The difference (FE 999049 - GONAL-F) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across age strata.|Percentage of participants with ongoing implantation rate||9.7|-0.9|
71838045|NCT03721952|143183308|SUPERIORITY||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.041||0.029|TWO_SIDED|95.0|0.009|0.169|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher proportion of readmissions \& negative sign of estimate defined as lower proportion of readmissions, for the intervention group vs. the control group|Superior outcome for Group2 (Patient-Intervention)||0.169|0.009|0.029
71838046|NCT03721952|143183309|SUPERIORITY||Slope|1.078|STANDARD_ERROR_OF_MEAN|0.808||0.183|TWO_SIDED|95.0|-0.511|2.666|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||2.666|-0.511|0.183
71838047|NCT03721952|143183310|SUPERIORITY||Slope|1.687|STANDARD_ERROR_OF_MEAN|3.157||0.593|TWO_SIDED|95.0|-4.518|7.892|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||7.892|-4.518|0.593
71892449|NCT01381094|143306463|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
71671682|NCT03296527|142861235|SUPERIORITY|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.79||||0.083|TWO_SIDED|95.0|0.6|1.03||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=15 oocytes retrieved||1.03|0.60|0.083
71671683|NCT03296527|142861235|OTHER|Logistic regression including AMH group as a factor.|Odds Ratio (OR)|0.89||||0.489|TWO_SIDED|95.0|0.65|1.23||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with \<4 or \>=20 oocytes retrieved||1.23|0.65|0.489
71671684|NCT03296527|142861236|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.6||||0.075|TWO_SIDED|95.0|0.34|1.06||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade)||1.06|0.34|0.075
71757611|NCT01746901|143018525|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1072|TWO_SIDED|95.0|-2.0|20.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.0|-2.0|0.1072
71757612|NCT01746901|143018525|SUPERIORITY_OR_OTHER||LS Mean Difference|26.3|||<|0.0001|TWO_SIDED|95.0|15.4|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.3|15.4|<0.0001
71757613|NCT01746901|143018525|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|14.7|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.6|14.7|<0.0001
71757614|NCT01746901|143018525|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0335|TWO_SIDED|95.0|0.9|22.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.9|0.9|0.0335
71671685|NCT03296527|142861236|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.75||||0.365|TWO_SIDED|95.0|0.4|1.4||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe)||1.40|0.40|0.365
71757615|NCT01746901|143018526|SUPERIORITY_OR_OTHER||LS Mean Difference|35.0|||<|0.0001|TWO_SIDED|95.0|24.0|46.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.0|24.0|<0.0001
71757616|NCT01746901|143018526|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9811|TWO_SIDED|95.0|-11.1|10.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.8|-11.1|0.9811
71757617|NCT01746901|143018526|SUPERIORITY_OR_OTHER||LS Mean Difference|9.0||||0.1083|TWO_SIDED|95.0|-2.0|19.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.9|-2.0|0.1083
71757618|NCT01746901|143018526|SUPERIORITY_OR_OTHER||LS Mean Difference|25.9|||<|0.0001|TWO_SIDED|95.0|14.9|36.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.9|14.9|<0.0001
71757619|NCT01746901|143018526|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|12.3|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|12.3|<0.0001
71757620|NCT01746901|143018526|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0408|TWO_SIDED|95.0|0.5|22.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.4|0.5|0.0408
71757621|NCT01746901|143018527|SUPERIORITY_OR_OTHER||LS Mean Difference|36.9|||<|0.0001|TWO_SIDED|95.0|25.2|48.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.7|25.2|<0.0001
71757622|NCT01746901|143018527|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2||||0.5968|TWO_SIDED|95.0|-14.9|8.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.6|-14.9|0.5968
71757623|NCT01746901|143018527|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1471|TWO_SIDED|95.0|-3.1|20.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.4|-3.1|0.1471
71757624|NCT01746901|143018527|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
71757625|NCT01746901|143018527|SUPERIORITY_OR_OTHER||LS Mean Difference|22.4||||0.0002|TWO_SIDED|95.0|10.6|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.2|10.6|0.0002
71892450|NCT01381094|143306463|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71757626|NCT01746901|143018527|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5||||0.1136|TWO_SIDED|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.3|-2.3|0.1136
71757627|NCT01746901|143018529|SUPERIORITY_OR_OTHER||LS Mean Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.6|37.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.4|19.6|<0.0001
71757628|NCT01746901|143018529|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6209|TWO_SIDED|95.0|-6.7|11.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|-6.7|0.6209
71757629|NCT01746901|143018529|SUPERIORITY_OR_OTHER||LS Mean Difference|7.5||||0.0997|TWO_SIDED|95.0|-1.4|16.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.3|-1.4|0.0997
71757630|NCT01746901|143018529|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2|||<|0.0001|TWO_SIDED|95.0|14.4|32.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.1|14.4|<0.0001
71757631|NCT01746901|143018529|SUPERIORITY_OR_OTHER||LS Mean Difference|16.6||||0.0003|TWO_SIDED|95.0|7.7|25.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|7.7|0.0003
71757632|NCT01746901|143018529|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0036|TWO_SIDED|95.0|4.4|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|4.4|0.0036
71757633|NCT01746901|143018530|SUPERIORITY_OR_OTHER||LS Mean Difference|29.9|||<|0.0001|TWO_SIDED|95.0|21.1|38.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.8|21.1|<0.0001
71757634|NCT01746901|143018530|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.4||||0.5951|TWO_SIDED|95.0|-11.2|6.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|-11.2|0.5951
71757635|NCT01746901|143018530|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.0841|TWO_SIDED|95.0|-1.1|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-1.1|0.0841
71757636|NCT01746901|143018530|SUPERIORITY_OR_OTHER||LS Mean Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.0|28.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.6|11.0|<0.0001
71757637|NCT01746901|143018530|SUPERIORITY_OR_OTHER||LS Mean Difference|14.5||||0.0014|TWO_SIDED|95.0|5.7|23.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.4|5.7|0.0014
71892451|NCT01381094|143306463|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71671686|NCT03296527|142861236|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.33||||0.012|TWO_SIDED|95.0|0.13|0.83||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with any preventive intervention||0.83|0.13|0.012
71892452|NCT01381094|143306463|SUPERIORITY||||||=|0.6781|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.6781
71757638|NCT01746901|143018530|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0172|TWO_SIDED|95.0|1.9|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|1.9|0.0172
71757639|NCT01746901|143018531|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4|||<|0.0001|TWO_SIDED|95.0|21.0|39.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.9|21.0|<0.0001
71757640|NCT01746901|143018531|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.9||||0.2166|TWO_SIDED|95.0|-15.4|3.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-15.4|0.2166
71757641|NCT01746901|143018531|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0777|TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-1.0|0.0777
71757642|NCT01746901|143018531|SUPERIORITY_OR_OTHER||LS Mean Difference|16.0||||0.0011|TWO_SIDED|95.0|6.5|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|6.5|0.0011
71757643|NCT01746901|143018531|SUPERIORITY_OR_OTHER||LS Mean Difference|12.7||||0.0086|TWO_SIDED|95.0|3.3|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.2|3.3|0.0086
71757644|NCT01746901|143018531|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5||||0.0775|TWO_SIDED|95.0|-0.9|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-0.9|0.0775
71757645|NCT01746901|143018533|SUPERIORITY_OR_OTHER||LS Mean Difference|61.2|||<|0.0001|TWO_SIDED|95.0|48.8|73.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.6|48.8|<0.0001
71757646|NCT01746901|143018533|SUPERIORITY_OR_OTHER||LS Mean Difference|18.8||||0.0032|TWO_SIDED|95.0|6.4|31.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.2|6.4|0.0032
71757647|NCT01746901|143018533|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
71757648|NCT01746901|143018533|SUPERIORITY_OR_OTHER||LS Mean Difference|47.2|||<|0.0001|TWO_SIDED|95.0|34.8|59.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.6|34.8|<0.0001
71757649|NCT01746901|143018533|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|61.1|86.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||86.0|61.1|<0.0001
71757650|NCT01746901|143018533|SUPERIORITY_OR_OTHER||LS Mean Difference|38.4|||<|0.0001|TWO_SIDED|95.0|26.0|50.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.8|26.0|<0.0001
71757651|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9|||<|0.0001|TWO_SIDED|95.0|36.0|51.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.8|36.0|<0.0001
71757652|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.4154|TWO_SIDED|95.0|-4.6|11.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.2|-4.6|0.4154
71757653|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|13.9|29.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|13.9|<0.0001
71757654|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|25.4|||<|0.0001|TWO_SIDED|95.0|17.5|33.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||33.3|17.5|<0.0001
71757655|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|20.2|||<|0.0001|TWO_SIDED|95.0|12.3|28.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|12.3|<0.0001
71892453|NCT01381094|143306463|SUPERIORITY||||||=|0.0524|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0524
71892454|NCT01381094|143306463|SUPERIORITY||||||=|0.0367|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0367
71892455|NCT01381094|143306463|SUPERIORITY||||||=|0.6671|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6671
71892456|NCT01381094|143306463|SUPERIORITY||||||=|0.6861|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.6861
71671687|NCT03296527|142861236|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.49||||0.004|TWO_SIDED|95.0|0.3|0.81||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (any grade) and/or preventive interventions||0.81|0.30|0.004
71671688|NCT03296527|142861236|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.56||||0.029|TWO_SIDED|95.0|0.33|0.95|||Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions||0.95|0.33|0.029
71671689|NCT03296527|142861237|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.52|13.74||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor response||13.74|1.52|0.002
71789434|NCT02772081|143076770|SUPERIORITY||Adjusted difference|-15.7||||0.22|TWO_SIDED|95.0|-39.6|8.2|||Cochran-Mantel-Haenszel|||Any intubation procedure in first 72 hours of life.||8.2|-39.6|0.220
71789435|NCT02772081|143076770|SUPERIORITY||Adjusted difference|4.9||||0.741|TWO_SIDED|95.0|-22.8|32.5|||Cochran-Mantel-Haenszel|||Any intubation procedure within 36 weeks PMA.||32.5|-22.8|0.741
71789436|NCT02772081|143076771|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.333|TWO_SIDED|95.0|-32.3|16.3|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV in first 28 days PNA.||16.3|-32.3|0.333
71789437|NCT02772081|143076771|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.334|TWO_SIDED|95.0|-49.5|33.5|||Wilcoxon (Mann-Whitney)|||Duration of invasive MV within 36 weeks PMA.||33.5|-49.5|0.334
71789438|NCT02772081|143076772|SUPERIORITY||Adjusted difference|-28.6||||0.596|TWO_SIDED|95.0|-120.9|63.6|||Wilcoxon (Mann-Whitney)|||Duration of invasive mechanical ventilation.||63.6|-120.9|0.596
71789439|NCT02772081|143076773|SUPERIORITY||CMH adjusted difference|-18.6||||0.219|TWO_SIDED|95.0|-47.0|9.8||The percentage of neonates needing invasive MV in the first 72 hours of life, was compared between the treatment groups using the Cochran-Mantel-Haenszel (CMH) test, adjusted for gestational age (GA) group.|Cochran-Mantel-Haenszel|||Invasive MV in the first 72 hours of life.||9.8|-47.0|0.219
71789440|NCT02772081|143076773|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV in first 28 days PNA||26.7|-33.5|0.826
71789441|NCT02772081|143076773|SUPERIORITY||Adjusted difference|-3.4||||0.826|TWO_SIDED|95.0|-33.5|26.7|||Cochran-Mantel-Haenszel|||Invasive MV within 36 weeks PMA.||26.7|-33.5|0.826
71789442|NCT02451839|143076780|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||< 0.001
71789443|NCT02451839|143076781|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789444|NCT02451839|143076782|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789445|NCT02451839|143076783|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789446|NCT02451839|143076784|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789447|NCT02451839|143076785|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789448|NCT02451839|143076786|SUPERIORITY|||||||0.015|||||||paired t-test|||||||0.015
71789449|NCT02451839|143076787|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789450|NCT02451839|143076788|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
71789451|NCT02451839|143076789|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789452|NCT02451839|143076790|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789453|NCT02451839|143076791|SUPERIORITY|||||||0.006|||||||paired t-test|||||||0.006
71789454|NCT02451839|143076792|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789455|NCT02451839|143076793|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789456|NCT02451839|143076794|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789457|NCT02451839|143076795|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71789458|NCT01291173|143076797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.014||||0.8825|TWO_SIDED|95.0|-0.203|0.175|||Mixed Models Analysis|||||0.175|-0.203|0.8825
71789459|NCT01291173|143076797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.258||||0.0077|TWO_SIDED|95.0|-0.446|-0.069|||Mixed Models Analysis|||||-0.069|-0.446|0.0077
71789460|NCT01291173|143076797|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.345||||0.0004|TWO_SIDED|95.0|-0.534|-0.155|||Mixed Models Analysis|||||-0.155|-0.534|0.0004
71789461|NCT01291173|143076798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4676|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.4676
71789462|NCT01291173|143076798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0198|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0198
71789463|NCT01291173|143076798|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0031
71789464|NCT01291173|143076799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3341|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.3341
71789465|NCT01291173|143076799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
71789466|NCT01291173|143076799|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0022
71789467|NCT01291173|143076800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0937|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0937
71789468|NCT01291173|143076800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0127
71789469|NCT01291173|143076800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0009
71789470|NCT01291173|143076803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0091|TWO_SIDED|95.0|||||Chi-squared|||||||0.0091
71789471|NCT01291173|143076803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED|95.0|||||Chi-squared|||||||0.0004
71789472|NCT01291173|143076803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||||||<0.0001
71671690|NCT03296527|142861237|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.24|0.62||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with transfer cancellation due to excessive ovarian response/OHSS risk||0.62|0.24|<0.001
71838048|NCT03721952|143183311|SUPERIORITY||Slope|4.365|STANDARD_ERROR_OF_MEAN|6.987||0.533|TWO_SIDED|95.0|-9.367|18.097|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of hospital free days \& negative sign of estimate defined as lower number of hospital free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||18.097|-9.367|0.533
71838049|NCT03721952|143183312|SUPERIORITY||Slope|1.07|STANDARD_ERROR_OF_MEAN|1.07||0.318|TWO_SIDED|95.0|-1.032|3.173|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||3.173|-1.032|0.318
71838050|NCT03721952|143183313|SUPERIORITY||Slope|4.117|STANDARD_ERROR_OF_MEAN|3.506||0.241|TWO_SIDED|95.0|-2.773|11.007|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||11.007|-2.773|0.241
71838051|NCT03721952|143183314|SUPERIORITY||Slope|8.195|STANDARD_ERROR_OF_MEAN|7.466||0.273|TWO_SIDED|95.0|-6.479|22.868|||Regression, Linear|Linear regression of outcome on group (0=control, 1=interv), adjusted for hospital, w robust standard error estimate using bias correction 1/(1-h)\^2.|Additional estimation information: Positive sign of estimate defined as higher number of ICU free days \& negative sign of estimate defined as lower number of ICU free days, for the intervention group vs. the control group.|Superior outcome for Group2 (Patient-Intervention)||22.868|-6.479|0.273
71838052|NCT03721952|143183315|SUPERIORITY||Slope|-0.0000009|STANDARD_ERROR_OF_MEAN|0.00000248||0.71|TWO_SIDED|95.0|-0.0000057|0.0000039|||other type of regression|Regression \[gamma family, link function g(u)=u-0.9\], outcome on random group (0=control, 1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000039|-0.0000057|0.710
71838053|NCT03721952|143183316|SUPERIORITY||Slope|0.00000113|STANDARD_ERROR_OF_MEAN|0.00000215||0.599|TWO_SIDED|95.0|-0.000003|0.0000053|||other type of regression|Regression \[inverse Gaussian family, link function g(u)=u-0.9\], outcome on random group (0=control,1=intervention), adjusted for hospital, robust SEs.||Superior outcome for Group2 (Patient-Intervention)||0.0000053|-0.0000030|0.599
71838054|NCT01000961|143183409|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104|Mean Difference (Final Values)|0.0785||||0.0001|TWO_SIDED|95.8|0.0107|0.1464|||t-test, 1 sided||95.8% confidence interval was used instead of 95% to take into account a sample size re-estimation calculation that was performed after 20 patients were enrolled.|16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.||0.1464|0.0107|0.0001
71838055|NCT01000961|143183410|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.4|||||TWO_SIDED|95.0|1.17|1.67||||||||1.67|1.17|
71838056|NCT01000961|143183411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|105.0|||||TWO_SIDED|95.0|90.0|150.0||||||||150|90|
71671691|NCT03296527|142861237|OTHER|Treatment groups were compared using a logistic regression model including age stratum as factor.|Odds Ratio (OR)|0.62||||0.02|TWO_SIDED|95.0|0.42|0.93||The p-value is based on the likelihood ratio test.|Regression, Logistic||Odds ratio is equal to FE 999049/GONAL-F.|Proportion of participants with cycle cancellation due to poor or excessive response, or transfer cancellation due to excessive response/OHSS risk||0.93|0.42|0.020
71671692|NCT03296527|142861238|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
71671693|NCT03296527|142861238|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
71671694|NCT03296527|142861238|SUPERIORITY|||||||0.568||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||0.568
71838057|NCT01000961|143183412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.03|||||TWO_SIDED|95.0|1.75|2.39||||||||2.39|1.75|
71838058|NCT03896789|143183417|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.95|TWO_SIDED|95.0|-3.3|3.5||The primary outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||"Null hypothesis: Assuming no difference between usual care (control) and PEGASUS (intervention).~We used 2011-2012 results from prior pilot work in Argentina (58.6% TBI guideline adherence) to determine a sample size of 432 eligible patients (216 per arm) for the planned parallel cluster RCT, which would have 80% power to detect a 18.7% higher ICU TBI guideline adherence rate with programme implementation, with a two-sided alpha of 5%, and an intraclass coefficient of 0.05."||3.5|-3.3|.95
71838059|NCT03896789|143183423|SUPERIORITY||Mean Difference (Final Values)|7.9||||0.01|TWO_SIDED|95.0|1.9|13.8||The outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.|Mixed Models Analysis|Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.||||13.8|1.9|.01
71838060|NCT05480124|143183426|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
71838061|NCT05480124|143183428|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||||||0.098
71838062|NCT05480124|143183429|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71789473|NCT01291173|143076804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.97||||0.0142|TWO_SIDED|95.0|-5.34|-0.6|||Mixed Models Analysis|||||-0.60|-5.34|0.0142
71757656|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|18.9|||<|0.0001|TWO_SIDED|95.0|11.0|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.0|<0.0001
71757657|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|114.2|||<|0.0001|TWO_SIDED|95.0|97.1|131.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||131.3|97.1|<0.0001
71757658|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3985|TWO_SIDED|95.0|-9.8|24.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.4|-9.8|0.3985
71757659|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.8|38.5|<0.0001
71757660|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|65.9|||<|0.0001|TWO_SIDED|95.0|48.8|83.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.0|48.8|<0.0001
71789474|NCT01291173|143076804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.25||||0.0075|TWO_SIDED|95.0|-5.62|-0.88|||Mixed Models Analysis|||||-0.88|-5.62|0.0075
71789475|NCT01291173|143076804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.93|||<|0.0001|TWO_SIDED|95.0|-7.3|-2.56|||Mixed Models Analysis|||||-2.56|-7.30|<0.0001
71671695|NCT03296527|142861238|SUPERIORITY|||||||0.839||||||2-sided|van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.839
71757661|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|55.6|||<|0.0001|TWO_SIDED|95.0|38.5|72.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.7|38.5|<0.0001
71757662|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|54.1|||<|0.0001|TWO_SIDED|95.0|37.0|71.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.2|37.0|<0.0001
71757663|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|302.8|||<|0.0001|TWO_SIDED|95.0|248.8|356.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.8|248.8|<0.0001
71757664|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|47.8||||0.0824|TWO_SIDED|95.0|-6.2|101.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.7|-6.2|0.0824
71757665|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|188.5|||<|0.0001|TWO_SIDED|95.0|134.6|242.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||242.5|134.6|<0.0001
71757666|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|162.0|||<|0.0001|TWO_SIDED|95.0|108.0|216.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||216.0|108.0|<0.0001
71757667|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|141.9|||<|0.0001|TWO_SIDED|95.0|87.9|195.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||195.8|87.9|<0.0001
71757668|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|135.7|||<|0.0001|TWO_SIDED|95.0|81.7|189.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.6|81.7|<0.0001
71757669|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|287.6|||<|0.0001|TWO_SIDED|95.0|219.1|356.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||356.1|219.1|<0.0001
71757670|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|101.4||||0.004|TWO_SIDED|95.0|32.9|169.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||169.8|32.9|0.0040
71757671|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|218.5|||<|0.0001|TWO_SIDED|95.0|150.0|287.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||287.0|150.0|<0.0001
71757672|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|170.5|||<|0.0001|TWO_SIDED|95.0|102.0|239.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||239.0|102.0|<0.0001
71789476|NCT01291173|143076805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15||||0.7538|TWO_SIDED|95.0|-1.11|0.8|||Mixed Models Analysis|||||0.80|-1.11|0.7538
71789477|NCT01291173|143076805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49||||0.3062|TWO_SIDED|95.0|-0.45|1.44|||Mixed Models Analysis|||||1.44|-0.45|0.3062
71789478|NCT01291173|143076805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.7697|TWO_SIDED|95.0|-0.81|1.09|||Mixed Models Analysis|||||1.09|-0.81|0.7697
71789479|NCT01291173|143076806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53||||0.2046|TWO_SIDED|95.0|-0.29|1.35|||Mixed Models Analysis|||||1.35|-0.29|0.2046
71671696|NCT03296527|142861239|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 10 mm||||<.001
71671697|NCT03296527|142861239|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 12 mm||||<.001
71671698|NCT03296527|142861239|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 15 mm||||<.001
71671699|NCT03296527|142861239|SUPERIORITY|||||||0.011|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of follicles \>= 17 mm||||0.011
71757673|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|158.6|||<|0.0001|TWO_SIDED|95.0|90.1|227.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.1|90.1|<0.0001
71789480|NCT01291173|143076806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3348|TWO_SIDED|95.0|-0.42|1.22|||Mixed Models Analysis|||||1.22|-0.42|0.3348
71789481|NCT01291173|143076806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.81||||0.0505|TWO_SIDED|95.0|0.0|1.63|||Mixed Models Analysis|||||1.63|-0.00|0.0505
71789482|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0371|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0371
71789483|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.1380
71789484|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED|95.0|||||Mixed Models Analysis|||Cognitive Restraint of Eating||||0.0459
71789485|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0278|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0278
71789486|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||0.0022
71671700|NCT03296527|142861240|SUPERIORITY|||||||0.14|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.140
71671701|NCT03296527|142861240|SUPERIORITY|||||||0.155|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.155
71671702|NCT03296527|142861240|SUPERIORITY|||||||0.159|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Treatment comparison: Average size of 3 largest follicles (mm)||||0.159
71671703|NCT03296527|142861241|SUPERIORITY|||||||0.848|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Largest follicle (mm)||||0.848
71671704|NCT03296527|142861241|SUPERIORITY|||||||0.629|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average follicle size (mm)||||0.629
71671705|NCT03296527|142861241|SUPERIORITY|||||||0.768|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Average size of 3 largest follicles (mm)||||0.768
71671706|NCT03296527|142861242|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Mean number of oocytes retrieved||||<.001
71671707|NCT03296527|142861244|SUPERIORITY|||||||0.197|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Percentage of MII oocytes / oocytes retrieved||||0.197
71671708|NCT03296527|142861245|SUPERIORITY|||||||0.79|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Fertilization rate relative to oocytes retrieved||||0.790
71671709|NCT03296527|142861246|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of embryos on day 3||||<.001
71757674|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|152.2|||<|0.0001|TWO_SIDED|95.0|83.7|220.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||220.7|83.7|<0.0001
71757675|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0002|TWO_SIDED|95.0|90.1|281.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.8|90.1|0.0002
71789487|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Disinhibition||||<0.0001
71789488|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0149|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0149
71789489|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||0.0009
71789490|NCT01291173|143076807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||Hunger||||<0.0001
71789491|NCT01291173|143076808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9||||0.03|TWO_SIDED|95.0|-7.44|-0.38|||Mixed Models Analysis|||||-0.38|-7.44|0.030
71789492|NCT01291173|143076808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||0.002|TWO_SIDED|95.0|-8.95|-1.94|||Mixed Models Analysis|||||-1.94|-8.95|0.002
71789493|NCT01291173|143076808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-11.99|-4.92|||Mixed Models Analysis|||||-4.92|-11.99|<0.001
71789494|NCT01291173|143076809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.65||||0.0824|TWO_SIDED|95.0|-5.64|0.34|||Mixed Models Analysis|||||0.34|-5.64|0.0824
71789495|NCT01291173|143076809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.07||||0.1725|TWO_SIDED|95.0|-5.05|0.91|||Mixed Models Analysis|||||0.91|-5.05|0.1725
71789496|NCT01291173|143076809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.71||||0.0148|TWO_SIDED|95.0|-6.69|-0.73|||Mixed Models Analysis|||||-0.73|-6.69|0.0148
71789497|NCT01291173|143076810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.2504|TWO_SIDED|95.0|-0.89|3.38|||Mixed Models Analysis|||Aggregate Physical Score||3.38|-0.89|0.2504
71838063|NCT05480124|143183430|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
71789498|NCT01291173|143076810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.09||||0.309|TWO_SIDED|95.0|-1.02|3.21|||Mixed Models Analysis|||Aggregate Physical Score||3.21|-1.02|0.3090
71789499|NCT01291173|143076810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0216|TWO_SIDED|95.0|0.37|4.64|||Mixed Models Analysis|||Aggregate Physical Score||4.64|0.37|0.0216
71789500|NCT01291173|143076810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.9587|TWO_SIDED|95.0|-2.75|2.9|||Mixed Models Analysis|||Aggregate Mental Score||2.90|-2.75|0.9587
71789501|NCT01291173|143076810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.653|TWO_SIDED|95.0|-2.17|3.45|||Mixed Models Analysis|||Aggregate Mental Score||3.45|-2.17|0.6530
71789502|NCT01291173|143076810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03||||0.9814|TWO_SIDED|95.0|-2.79|2.86|||Mixed Models Analysis|||Aggregate Mental Score||2.86|-2.79|0.9814
71789503|NCT01506479|143076828|SUPERIORITY||Mean Difference (Final Values)|14.3|||<|0.0001|TWO_SIDED|95.0|12.0|16.6|||t-test, 2 sided|||||16.6|12.0|<0.0001
71789504|NCT01506479|143076829|OTHER||Mean Difference (Final Values)|2.9||||0.34|ONE_SIDED|90.0||4.6||The a priori threshold for statistical significance was 0.10|t-test, 1 sided|||The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.||4.6||0.34
71789505|NCT01506479|143076829|OTHER||Mean Difference (Final Values)|1.2||||0.03|ONE_SIDED|90.0||2.8||The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).|t-test, 1 sided||"The estimate is the difference between the control group and the moderate exercise group.~The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis."|The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .||2.8||0.03
71789506|NCT01506479|143076830|SUPERIORITY|||||||0.1334|||||||t-test, 2 sided|||||||0.1334
71789507|NCT00810407|143076833|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was diagnosis. The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events."||||<0.001
71789508|NCT00810407|143076834|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||"The factor tested was gender. The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events."||||<0.001
71789509|NCT00810407|143076835|SUPERIORITY_OR_OTHER|||||||0.587|||||||Fisher Exact|||"The factor tested was age. The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events."||||0.587
71671710|NCT03296527|142861246|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value based on van Elteren test adjusted for age stratum.||Number of good-quality embryos on Day 3||||<.001
71789510|NCT00810407|143076835|SUPERIORITY_OR_OTHER|||||||0.428|||||||Cochran-Armitage (EXACT)|||"The factor tested was age. The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline."||||0.428
71789511|NCT00530764|143076853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.33|TWO_SIDED|95.0|0.72|2.6|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.||2.60|0.72|0.33
71789512|NCT00530764|143076853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.62|TWO_SIDED|95.0|0.46|1.76|||Regression, Logistic|||As for Sativex Low dose versus placebo||1.76|0.46|0.62
71789513|NCT00530764|143076853|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.61|TWO_SIDED|95.0|0.62|2.28|||Regression, Logistic|||As for Sativex Low dose versus placebo||2.28|0.62|0.61
71789514|NCT00530764|143076854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.5||||0.0077|TWO_SIDED|95.0|-21.35|-3.33|||Wilcoxon rank sum tests|||Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.||-3.33|-21.35|0.0077
71789515|NCT00530764|143076854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.97||||0.67|TWO_SIDED|95.0|-11.04|7.14|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||7.14|-11.04|0.67
71789516|NCT00530764|143076854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.75||||0.039|TWO_SIDED|95.0|-17.14|0.0|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo||0.00|-17.14|0.039
71789517|NCT00530764|143076855|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.75||||0.006|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.||-0.22|-1.28|0.006
71789518|NCT00530764|143076855|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.09||||0.75|TWO_SIDED|95.0|-0.62|0.44|||ANCOVA|||As for Sativex low dose versus placebo||0.44|-0.62|0.75
71789519|NCT00530764|143076855|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.36||||0.19|TWO_SIDED|95.0|-0.89|0.18|||ANCOVA|||As for Sativex low dose versus placebo||0.18|-0.89|0.19
71789520|NCT00530764|143076856|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.73||||0.011|TWO_SIDED|95.0|-1.3|-0.17|||ANCOVA|||The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.17|-1.30|0.011
71789521|NCT00530764|143076856|SUPERIORITY_OR_OTHER||Estimated treatment effect|-0.35||||0.14|TWO_SIDED|95.0|-0.81|0.11|||ANCOVA|||As for Sativex low dose versus placebo||0.11|-0.81|0.14
71789522|NCT00530764|143076856|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.24||||0.4|TWO_SIDED|95.0|-0.81|0.32|||ANCOVA|||As for Sativex low dose versus placebo||0.32|-0.81|0.40
71789523|NCT00530764|143076857|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.88||||0.003|TWO_SIDED|95.0|-1.45|-0.31|||ANCOVA|||The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.||-0.31|-1.45|0.003
71671711|NCT03296527|142861247|SUPERIORITY||Mean ratio|0.81|||<|0.001|TWO_SIDED|95.0|0.74|0.88||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of LH on stimulation Day 6||0.88|0.74|<0.001
71671712|NCT03296527|142861248|SUPERIORITY||Mean ratio|0.9||||0.018|TWO_SIDED|95.0|0.82|0.98||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of LH at end-of-stimulation||0.98|0.82|0.018
71789524|NCT00530764|143076857|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.08||||0.78|TWO_SIDED|95.0|-0.65|0.49|||ANCOVA|||As for Sativex low dose versus placebo||0.49|-0.65|0.78
71789525|NCT00530764|143076857|SUPERIORITY_OR_OTHER||Estimated Treatment Effect|-0.33||||0.26|TWO_SIDED|95.0|-0.9|0.24|||ANCOVA|||As for Sativex low dose versus placebo.||0.24|-0.90|0.26
71789526|NCT03557151|143076874|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.33||0.895|TWO_SIDED|95.0|-0.68|0.6|||Mixed Models Analysis|||Transdisciplinary Care is being compared to Usual Care using the Time 2 HbA1c (as baseline) and Time 5 HbA1c (as the outcome) controlling for race/ethnicity, gender, and age of the patient. The interaction of condition and time is used to evaluate the treatment effect. Missing data were not imputed.||0.60|-0.68|0.895
71789527|NCT03557151|143076875|SUPERIORITY||Slope|2.29|STANDARD_ERROR_OF_MEAN|2.34||0.33|TWO_SIDED|95.0|-2.29|6.88|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data, controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to examine the treatment effect. Missing data were not imputed.||6.88|-2.29|.33
71789528|NCT03557151|143076876|SUPERIORITY||Slope|4.1|STANDARD_ERROR_OF_MEAN|2.25||0.07|TWO_SIDED|95.0|-0.32|8.53|||Mixed Models Analysis|||TC is being compared to UC using baseline and 12 month data and controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to evaluate the treatment effect. Missing data are not imputed.||8.53|-.32|.07
71789529|NCT03557151|143076877|SUPERIORITY||Slope|-2.38|STANDARD_ERROR_OF_MEAN|3.77||0.527|TWO_SIDED|95.0|-9.77|5.0|||Mixed Models Analysis|||This analysis included baseline and 12-month data. The interaction of condition (TC or UC) and time was used to examine the treatment effect. Child sex, age, and race/ethnicity were covariates. Missing data were not imputed.||5.0|-9.77|.527
71789530|NCT03557151|143076878|SUPERIORITY||Slope|-3.3|STANDARD_ERROR_OF_MEAN|2.89||0.253|TWO_SIDED|95.0|-8.94|2.35|||Mixed Models Analysis|||This analysis uses baseline and 12 month data. The interaction of condition and time is used to evaluate the treatment effect. Child sex, age, and race/ethnicity were used as covariates. Missing data were not imputed.||2.35|-8.94|.253
71789531|NCT03557151|143076879|SUPERIORITY||Slope|9.69|STANDARD_ERROR_OF_MEAN|3.77||0.01|TWO_SIDED|95.0|2.31|17.08|||Mixed Models Analysis|||This analysis included baseline and 12 month data. The condition by time interaction was used to evaluate the treatment effect. Child age, sex, and race/ethnicity were included as covariates. Missing data were not imputed.||17.08|2.31|0.01
71789532|NCT03557151|143076880|SUPERIORITY||Slope|0.45|STANDARD_ERROR_OF_MEAN|2.07||0.83|TWO_SIDED|95.0|-3.62|4.35|||Mixed Models Analysis|||This analysis uses baseline and 12-month data. The interaction between condition and time is used to evaluate the treatment effect. Child age, sex, and race/ethnicity were covariates. Missing data were not imputed.||4.35|-3.62|.83
71789533|NCT01414075|143076881|OTHER|||||||0.0757||||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0757
71789534|NCT01414075|143076881|OTHER|||||||0.063||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.0630
71789535|NCT01414075|143076881|OTHER|||||||0.8653||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8653
71789536|NCT01414075|143076881|OTHER|||||||0.8982||||||Threshold for significance at 0.05 level.|ANCOVA|||ANCOVA model with treatment as a factor, baseline Hb and iron repletion status as covariates was used to compare treatments.||||0.8982
71789537|NCT00467259|143076925|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
71671713|NCT03296527|142861249|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.84||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol on stimulation Day 6||0.84|0.70|<0.001
71789538|NCT00467259|143076926|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
71789539|NCT00467259|143076927|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.||||1.0000
71838064|NCT05480124|143183431|SUPERIORITY|||||||0.201|||||||t-test, 2 sided|||||||0.201
71838065|NCT05349500|143183435|SUPERIORITY||Mean Difference (Final Values)|-11.0||||0.019|TWO_SIDED|95.0|-20.1|-1.9|||Mixed Models Analysis|||||-1.9|-20.1|0.019
71671714|NCT03296527|142861250|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.81||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Estradiol at end-of-stimulation||0.81|0.68|<0.001
71671715|NCT03296527|142861251|SUPERIORITY||Mean Ratio|0.89||||0.003|TWO_SIDED|95.0|0.82|0.96||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone on stimulation Day 6||0.96|0.82|0.003
71671716|NCT03296527|142861252|SUPERIORITY||Mean ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.79||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Progesterone at end-of-stimulation||0.79|0.68|<0.001
71671717|NCT03296527|142861253|SUPERIORITY||Mean ratio|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.||Circulating concentrations of Inhibin A on stimulation Day 6||0.83|0.70|<0.001
71671718|NCT03296527|142861254|SUPERIORITY||Mean ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin A at end-of-stimulation||0.83|0.71|<0.001
71671719|NCT03296527|142861255|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.89||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B on stimulation Day 6||0.89|0.77|<0.001
71671720|NCT03296527|142861256|SUPERIORITY||Mean ratio|0.87||||0.001|TWO_SIDED|95.0|0.8|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of Inhibin B at end-of-stimulation||0.95|0.80|0.001
71757676|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|205.0|||<|0.0001|TWO_SIDED|95.0|109.2|300.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||300.8|109.2|<0.0001
71757677|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|221.0|||<|0.0001|TWO_SIDED|95.0|125.2|316.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.7|125.2|<0.0001
71789540|NCT00818662|143076953|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.8||||0.476||95.0|-3.1|1.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||1.5|-3.1|0.476
71789541|NCT00818662|143076953|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.53||95.0|-1.6|3.0|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.0|-1.6|0.530
71671721|NCT03296527|142861257|SUPERIORITY||Mean ratio|1.08|||<|0.001|TWO_SIDED|95.0|1.04|1.12||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH on stimulation Day 6||1.12|1.04|<0.001
71671722|NCT03296527|142861258|SUPERIORITY||Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.95||The p-value corresponds to F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at end-of-stimulation||0.95|0.89|<0.001
71671723|NCT03296527|142861259|SUPERIORITY||Mean ratio|1.03||||0.184|TWO_SIDED|95.0|0.99|1.07||The p-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The multiplicative ANCOVA model included treatment and age stratum as fixed factors.|Mean ratio is equal to FE 999049/GONAL-F.|Circulating concentrations of FSH at oocyte retrieval visit||1.07|0.99|0.184
71757678|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0006|TWO_SIDED|95.0|74.1|265.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||265.8|74.1|0.0006
71757679|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|185.7||||0.0002|TWO_SIDED|95.0|89.9|281.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||281.5|89.9|0.0002
71757680|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|144.9||||0.0033|TWO_SIDED|95.0|49.1|240.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.8|49.1|0.0033
71757681|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|170.0||||0.0017|TWO_SIDED|95.0|65.2|274.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||274.9|65.2|0.0017
71789542|NCT00818662|143076954|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.812||95.0|-2.9|3.7|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||3.7|-2.9|0.812
71789543|NCT00818662|143076954|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.9||||0.602||95.0|-4.3|2.5|||ANCOVA||Results combined from 100 imputations from estimates \& standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, \& continuous covariates age at baseline, baseline ADAS-Cog \& education level|||2.5|-4.3|0.602
71789544|NCT00818662|143076955|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.7||||0.368||95.0|-2.3|0.8|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||0.8|-2.3|0.368
71671724|NCT03296527|142861260|SUPERIORITY||||||<|0.001|||||||van Elteren test|p-value is based on van Elteren test adjusted for AMH group.||Total gonadotropin dose||||<.001
71671725|NCT03296527|142861262|SUPERIORITY|Treatment groups were compared using the van Elteren test.||||||0.001|||||||van Elteren|p-value is based on van Elteren test adjusted for AMH group.||Number of stimulation days||||0.001
71671726|NCT00122382|142861290|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.1|||<|0.001|TWO_SIDED|95.0|6.0|24.2||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving an ACR 50 response.||24.2|6.0|<0.001
71671727|NCT00122382|142861291|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|15.5|||<|0.001|TWO_SIDED|95.0|8.2|22.8||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving MCR.||22.8|8.2|<0.001
71671728|NCT00122382|142861292|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|-0.73|||<|0.001|TWO_SIDED|95.0|-0.98|-0.48||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||||-0.48|-0.98|<0.001
71671729|NCT00122382|142861293|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|9.8||||0.024|TWO_SIDED|95.0|1.3|18.4||p-value of \<0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving HAQ response.||18.4|1.3|0.024
71789545|NCT00818662|143076955|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.8||||0.319||95.0|-0.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)|||2.4|-0.8|0.319
71789546|NCT00818662|143076956|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.778||95.0|-1.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||2.4|-1.8|0.778
71789547|NCT00818662|143076956|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.851||95.0|-2.3|1.9|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)|||1.9|-2.3|0.851
71789548|NCT00818662|143076957|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.306||95.0|-0.1|0.3|||Mixed Models Analysis|||||0.3|-0.1|0.306
71671730|NCT00122382|142861294|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|2.5||||0.005|TWO_SIDED|95.0|0.77|4.23||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||PCS Adjusted Mean Change from Baseline to Month 12||4.23|0.77|0.005
71671731|NCT00122382|142861294|SUPERIORITY_OR_OTHER||Estimate of/Adjusted Difference|1.81||||0.046|TWO_SIDED|95.0|0.03|3.6||p-value of \<0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||MCS Adjusted Mean Change from Baseline to Month 12||3.60|0.03|0.046
71671732|NCT00122382|142861295|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in erosion scores between abatacept and placebo||||0.033
71671733|NCT00122382|142861295|SUPERIORITY_OR_OTHER|||||||0.353||95.0||||P-value of \<0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in JSN scores between abatacept and placebo||||0.353
71671734|NCT00122382|142861297|SUPERIORITY_OR_OTHER||Estimated Difference between ABA and PLA|18.1|||<|0.001|TWO_SIDED|95.0|9.6|26.6||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving DAS28-CRP remission.||26.6|9.6|<0.001
71671735|NCT00122382|142861298|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|non-parametric ANCOVA|||||||<0.040
71671736|NCT00122382|142861313|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||signed rank test|||||||<0.001
71789549|NCT00818662|143076957|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.3||||0.028||95.0|0.0|0.5|||Mixed Models Analysis|||||0.5|0.0|0.028
71671737|NCT02040805|142861316|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 5 points.||||||0.04|||||||t-test, 1 sided|||Test of non-inferiority.||||0.04
71671738|NCT02040805|142861317|NON_INFERIORITY|Margin based on clinically meaningful change of \>= 2.5 points.||||||0.05|||||||t-test, 1 sided|||Test of non-inferiority.||||0.05
71671739|NCT02040805|142861318|OTHER|linear mixed models analysis|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
71789550|NCT00818662|143076958|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.66||95.0|-0.3|0.2|||Mixed Models Analysis|||||0.2|-0.3|0.660
71789551|NCT00818662|143076958|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.766||95.0|-0.2|0.3|||Mixed Models Analysis|||||0.3|-0.2|0.766
71789552|NCT00818662|143076959|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.9||||0.206||95.0|-1.0|4.8|||ANCOVA|||||4.8|-1.0|0.206
71789553|NCT00818662|143076959|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.4||||0.331||95.0|-4.3|1.5|||ANCOVA|||||1.5|-4.3|0.331
71789554|NCT00818662|143076960|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.7||||0.64||95.0|-2.1|3.4|||ANCOVA|||||3.4|-2.1|0.640
71789555|NCT00818662|143076960|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|2.5||||0.075||95.0|-0.3|5.3|||ANCOVA|||||5.3|-0.3|0.075
71671740|NCT02040805|142861319|OTHER|linear mixed model|||||<|0.0001|||||||Mixed Models Analysis|df=1||||||<0.0001
71757682|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|211.4||||0.0001|TWO_SIDED|95.0|106.6|316.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||316.2|106.6|0.0001
71757683|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|219.2|||<|0.0001|TWO_SIDED|95.0|114.5|324.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||324.0|114.5|<0.0001
71757684|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|162.2||||0.0027|TWO_SIDED|95.0|57.3|267.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||267.0|57.3|0.0027
71757685|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|185.9||||0.0006|TWO_SIDED|95.0|81.1|290.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.7|81.1|0.0006
71757686|NCT01746901|143018534|SUPERIORITY_OR_OTHER||LS Mean Difference|135.5||||0.0116|TWO_SIDED|95.0|30.7|240.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||240.4|30.7|0.0116
71757687|NCT01746901|143018535|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.3|-1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.5|-4.3|<0.0001
71757688|NCT01746901|143018535|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.0001|TWO_SIDED|95.0|1.4|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.4|0.0001
71757689|NCT01746901|143018535|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7005|TWO_SIDED|95.0|-1.7|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.7|0.7005
71757690|NCT01746901|143018535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.844|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8440
71757691|NCT01746901|143018535|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7295|TWO_SIDED|95.0|-1.6|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.1|-1.6|0.7295
71757692|NCT01746901|143018535|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.8757|TWO_SIDED|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-1.3|0.8757
71757693|NCT01746901|143018536|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|47.4|72.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||72.9|47.4|<0.0001
71789556|NCT00818662|143076961|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.093||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.093
71789557|NCT00818662|143076961|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.1||||0.094||95.0|-0.2|2.3|||ANCOVA|||||2.3|-0.2|0.094
71757694|NCT01746901|143018536|SUPERIORITY_OR_OTHER||LS Mean Difference|12.6||||0.0514|TWO_SIDED|95.0|-0.1|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.4|-0.1|0.0514
71757695|NCT01746901|143018536|SUPERIORITY_OR_OTHER||LS Mean Difference|29.7|||<|0.0001|TWO_SIDED|95.0|17.0|42.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||42.4|17.0|<0.0001
71757696|NCT01746901|143018536|SUPERIORITY_OR_OTHER||LS Mean Difference|43.0|||<|0.0001|TWO_SIDED|95.0|30.3|55.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.8|30.3|<0.0001
71757697|NCT01746901|143018536|SUPERIORITY_OR_OTHER||LS Mean Difference|33.7|||<|0.0001|TWO_SIDED|95.0|21.0|46.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.4|21.0|<0.0001
71757698|NCT01746901|143018536|SUPERIORITY_OR_OTHER||LS Mean Difference|36.4|||<|0.0001|TWO_SIDED|95.0|23.7|49.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.1|23.7|<0.0001
71757699|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|39.5|||<|0.0001|TWO_SIDED|95.0|31.8|47.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.2|31.8|<0.0001
71892457|NCT01381094|143306463|SUPERIORITY||||||=|0.9012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9012
71789558|NCT00818662|143076962|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.096||95.0|-2.3|0.2|||ANCOVA|||||0.2|-2.3|0.096
71789559|NCT00818662|143076962|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.0||||0.123||95.0|-2.2|0.3|||ANCOVA|||||0.3|-2.2|0.123
71789560|NCT00818662|143076963|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.167||95.0|-0.2|1.0|||ANCOVA|||||1.0|-0.2|0.167
71789561|NCT00818662|143076963|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.998||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.998
71892458|NCT01381094|143306464|SUPERIORITY||||||=|0.3953|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.3953
71789562|NCT00818662|143076964|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.173||95.0|-0.2|0.9|||ANCOVA|||||0.9|-0.2|0.173
71789563|NCT00818662|143076964|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.1||||0.744||95.0|-0.4|0.6|||ANCOVA|||||0.6|-0.4|0.744
71789564|NCT00818662|143076965|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|1.5||||0.238||95.0|-1.0|4.0|||ANCOVA|||||4.0|-1.0|0.238
71838066|NCT05349500|143183436|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.286|TWO_SIDED|95.0|-14.1|4.3|||Mixed Models Analysis|||||4.3|-14.1|0.286
71838067|NCT05349500|143183437|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.046|TWO_SIDED|95.0|-4.0|0.0|||Mixed Models Analysis|||||-0.0|-4.0|0.046
71838068|NCT05349500|143183438|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.128|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||||0.5|-3.8|0.128
71671741|NCT01008605|142861320|SUPERIORITY_OR_OTHER||Lower limit, 95% one-sided CI|95.83|||||ONE_SIDED|95.0|87.46||||||||||87.46|
71671742|NCT01213966|142861327|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||PPR24 was summarized descriptively. No statistical test was performed. The PRR24 values were summarised when the corresponding regression fit had a p-value of p ≤0.01 and an adjusted coefficient of determination (R2) ≥0.85.|Regression, Linear|||PPR24 was summarised descriptively. No statistical test was performed.||||0.01
71757700|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.2739|TWO_SIDED|95.0|-3.4|12.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.0|-3.4|0.2739
71757701|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4|||<|0.0001|TWO_SIDED|95.0|8.7|24.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.1|8.7|<0.0001
71757702|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4|||<|0.0001|TWO_SIDED|95.0|19.7|35.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.0|19.7|<0.0001
71757703|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|20.5|||<|0.0001|TWO_SIDED|95.0|12.8|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|12.8|<0.0001
71757704|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|12.0|27.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.4|12.0|<0.0001
71757705|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|104.7|||<|0.0001|TWO_SIDED|95.0|87.7|121.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.8|87.7|<0.0001
71757706|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.4003|TWO_SIDED|95.0|-9.8|24.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.3|-9.8|0.4003
71757707|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|43.6|||<|0.0001|TWO_SIDED|95.0|26.6|60.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||60.7|26.6|<0.0001
71757708|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|68.4|||<|0.0001|TWO_SIDED|95.0|51.3|85.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||85.4|51.3|<0.0001
71757709|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|54.3|||<|0.0001|TWO_SIDED|95.0|37.3|71.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.4|37.3|<0.0001
71757710|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|53.0|||<|0.0001|TWO_SIDED|95.0|36.0|70.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||70.1|36.0|<0.0001
71757711|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|292.5|||<|0.0001|TWO_SIDED|95.0|240.0|345.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||345.1|240.0|<0.0001
71757712|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|32.2||||0.2277|TWO_SIDED|95.0|-20.3|84.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.7|-20.3|0.2277
71789565|NCT00818662|143076965|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.1||||0.4||95.0|-3.6|1.4|||ANCOVA|||||1.4|-3.6|0.400
71789566|NCT00818662|143076966|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.6||||0.695||95.0|-3.6|2.4|||ANCOVA|||||2.4|-3.6|0.695
71789567|NCT00818662|143076966|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.3||||0.41||95.0|-4.5|1.9|||ANCOVA|||||1.9|-4.5|0.410
71789568|NCT00818662|143076967|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.0||||0.988||95.0|-1.5|1.5|||ANCOVA|||||1.5|-1.5|0.988
71838069|NCT05349500|143183439|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.031|TWO_SIDED|95.0|-14.3|-0.7|||Mixed Models Analysis|||||-0.7|-14.3|0.031
71838070|NCT05349500|143183440|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.564|TWO_SIDED|95.0|-8.8|4.9|||Mixed Models Analysis|||||4.9|-8.8|0.564
71838071|NCT05349500|143183441|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.349|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.349
71838072|NCT05349500|143183442|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.303
71838073|NCT05349500|143183443|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.507|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.2|-0.1|0.507
71838074|NCT05349500|143183444|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.729|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||||0.2|-0.2|0.729
71757713|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|173.1|||<|0.0001|TWO_SIDED|95.0|120.5|225.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.6|120.5|<0.0001
71757714|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|151.7|||<|0.0001|TWO_SIDED|95.0|99.1|204.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||204.2|99.1|<0.0001
71838075|NCT05349500|143183445|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.421|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.421
71838076|NCT05349500|143183446|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.648|TWO_SIDED|95.0|-0.2|0.1|||Mixed Models Analysis|||||0.1|-0.2|0.648
71757715|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|129.8|||<|0.0001|TWO_SIDED|95.0|77.2|182.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||182.3|77.2|<0.0001
71838077|NCT05349500|143183447|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.034|TWO_SIDED|95.0|0.3|6.5|||Mixed Models Analysis|||||6.5|0.3|0.034
71757716|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|122.6|||<|0.0001|TWO_SIDED|95.0|70.0|175.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||175.1|70.0|<0.0001
71757717|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|295.3|||<|0.0001|TWO_SIDED|95.0|228.3|362.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||362.2|228.3|<0.0001
71757718|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|69.6||||0.0416|TWO_SIDED|95.0|2.7|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|2.7|0.0416
71757719|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|204.4|||<|0.0001|TWO_SIDED|95.0|137.5|271.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||271.3|137.5|<0.0001
71789569|NCT00818662|143076967|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|0.4||||0.555||95.0|-1.0|1.9|||ANCOVA|||||1.9|-1.0|0.555
71789570|NCT00818662|143076968|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.5||||0.783||95.0|-12.2|9.2|||ANCOVA|||||9.2|-12.2|0.783
71757720|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|160.5|||<|0.0001|TWO_SIDED|95.0|93.5|227.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.4|93.5|<0.0001
71757721|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|133.0||||0.0001|TWO_SIDED|95.0|66.1|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|66.1|0.0001
71757722|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|140.1|||<|0.0001|TWO_SIDED|95.0|73.1|207.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.0|73.1|<0.0001
71757723|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|219.5|||<|0.0001|TWO_SIDED|95.0|127.6|311.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||311.3|127.6|<0.0001
71757724|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|145.0||||0.0022|TWO_SIDED|95.0|53.2|236.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.8|53.2|0.0022
71757725|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|200.2|||<|0.0001|TWO_SIDED|95.0|108.4|292.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||292.0|108.4|<0.0001
71757726|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|164.3||||0.0005|TWO_SIDED|95.0|72.4|256.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||256.1|72.4|0.0005
71757727|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|146.6||||0.0019|TWO_SIDED|95.0|54.8|238.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||238.4|54.8|0.0019
71838078|NCT05349500|143183448|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.315|TWO_SIDED|95.0|-2.1|6.3|||Mixed Models Analysis|||||6.3|-2.1|0.315
71789571|NCT00818662|143076968|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-2.1||||0.7||95.0|-13.1|8.8|||ANCOVA|||||8.8|-13.1|0.700
71789572|NCT00818662|143076969|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-15.2||||0.191||95.0|-38.0|7.7|||ANCOVA|||||7.7|-38.0|0.191
71789573|NCT00818662|143076969|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-1.6||||0.892||95.0|-25.4|22.1|||ANCOVA|||||22.1|-25.4|0.892
71838079|NCT05349500|143183449|SUPERIORITY||Mean Difference (Final Values)|13.4||||0.444|TWO_SIDED|95.0|-21.5|48.2|||Mixed Models Analysis|||||48.2|-21.5|0.444
71838080|NCT05349500|143183450|SUPERIORITY||Mean Difference (Final Values)|9.3||||0.638|TWO_SIDED|95.0|-30.6|49.2|||Mixed Models Analysis|||||49.2|-30.6|0.638
71838081|NCT05349500|143183451|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.688|TWO_SIDED|95.0|-13.4|8.9|||Mixed Models Analysis|||||8.9|-13.4|0.688
71838082|NCT05349500|143183452|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.709|TWO_SIDED|95.0|-2.5|1.7|||Mixed Models Analysis|||||1.7|-2.5|0.709
71838083|NCT05349500|143183453|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.089|TWO_SIDED|95.0|-3.3|0.2|||Mixed Models Analysis|||||0.2|-3.3|0.089
71838084|NCT05349500|143183454|SUPERIORITY||Mean Difference (Final Values)|14.9||||0.066|TWO_SIDED|95.0|-1.0|30.8|||Mixed Models Analysis|||||30.8|-1.0|0.066
71671743|NCT03655405|142861353|SUPERIORITY||Incidence Rate Ratio|0.972||||0.723|TWO_SIDED|95.0|0.83|1.138|||Regression, Poisson|Number of PIMs at follow-up, adjusted for baseline value||||1.138|0.830|0.723
71671744|NCT03655405|142861354|SUPERIORITY||Incidence Rate Ratio|0.763||||0.033|TWO_SIDED|95.0|0.594|0.979|||Regression, Poisson|Number of potentially inappropriate DDD at follow-up, adjusted for baseline value||||0.979|0.594|0.033
71789574|NCT00818662|143076970|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.1||||0.588||95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.588
71789575|NCT00818662|143076970|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-square means|-0.2||||0.351||95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.351
71789576|NCT01346839|143076988|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Cox|||||||<0.05
71789577|NCT02723084|143077063|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of -10%, then arm A was considered non-inferior to arm B.|Risk Difference (RD)|4.3|||||TWO_SIDED|95.0|-3.5|12.1|||||95% CI was calculated using the normal approximation to the binomial distribution.|Difference in SVR12 rates (Arm A - Arm B)||12.1|-3.5|
71789578|NCT01409564|143077080|SUPERIORITY_OR_OTHER|||||||0.14|||||||Repeated ANOVA|Uncorrected, Repeated ANOVA||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.14
71789579|NCT01409564|143077080|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).||||0.08
71789580|NCT01409564|143077080|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||<0.01
71789581|NCT01409564|143077080|SUPERIORITY_OR_OTHER|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group\*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).||||0.08
71789582|NCT01409564|143077081|SUPERIORITY_OR_OTHER|||||||0.93|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)||||0.93
71789583|NCT01409564|143077082|SUPERIORITY_OR_OTHER|||||||0.15|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)||||0.15
71789584|NCT01409564|143077083|SUPERIORITY_OR_OTHER|||||||0.82|||||||Repeated ANOVA|||Repeated ANOVA, tested for group\*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)||||0.82
71671745|NCT03655405|142861355|SUPERIORITY||Incidence Rate Ratio|0.915||||0.064|TWO_SIDED|95.0|0.834|1.005|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.005|0.834|0.064
71671746|NCT03655405|142861356|SUPERIORITY||Incidence Rate Ratio|1.019||||0.857|TWO_SIDED|95.0|0.833|1.246|||Regression, Poisson|Number of chronic drugs at follow-up, adjusted for baseline value||||1.246|0.833|0.857
71671747|NCT03655405|142861358|SUPERIORITY||Slope|-1.36||||0.769|TWO_SIDED|95.0|-10.6|7.89|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the scale component||7.89|-10.60|0.769
71671748|NCT03655405|142861358|SUPERIORITY||Slope|-0.096||||0.075|TWO_SIDED|95.0|-0.202|0.01|||Regression, Linear|Scale value at follow-up, adjusted for baseline value||Analysis for the index component||0.01|-0.202|0.075
71789585|NCT01409564|143077084|SUPERIORITY_OR_OTHER|||||||0.79|||||||Chi-squared|||Repeated ANOVA, tested for group\*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)||||0.79
71671749|NCT03655405|142861359|SUPERIORITY||Incidence Rate Ratio|1.237||||0.212|TWO_SIDED|95.0|0.886|1.727|||Mixed-effect regression, Poisson|Number at follow-up, adjusted for baseline value||||1.727|0.886|0.212
71671750|NCT03655405|142861360|SUPERIORITY||p-value|0.675||||0.675|TWO_SIDED||||||Fisher Exact|||||||0.675
71671751|NCT03655405|142861361|SUPERIORITY||p-value|0.615||||0.615|TWO_SIDED||||||Fisher Exact|||||||0.615
71789586|NCT01409564|143077085|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||Distribution of Fazekas scale in two groups according to Chi-square test results.||||0.87
71789587|NCT01042236|143077140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.88||0.4907|TWO_SIDED|95.0|-1.18|2.41||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||2.41|-1.18|0.4907
71789588|NCT01042236|143077140|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.88||0.5944|TWO_SIDED|95.0|-2.27|1.32||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.32|-2.27|0.5944
71838085|NCT03640312|143183468|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18||Adjusting for baseline systolic blood pressure.|Mixed Models Analysis|Difference in Least Squared Means (LSM). Random participant effect, fixed baseline, study arm, and time effects.||||1.18|-10.74|0.114
71838086|NCT03640312|143183469|SUPERIORITY|Adjusted for baseline systolic blood pressure.|Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.18|||Mixed Models Analysis|||||1.18|-10.74|0.114
71671752|NCT03655405|142861362|SUPERIORITY||p-value|0.366||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.366
71671753|NCT03655405|142861363|SUPERIORITY||p-value|0.738||||0.738|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.738
71671754|NCT03655405|142861364|SUPERIORITY||p-value|0.781||||0.781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.781
71671755|NCT03655405|142861365|SUPERIORITY||p-value|0.958||||0.958|TWO_SIDED||||||Fisher Exact|||||||0.958
71838087|NCT03640312|143183470|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11||Adjusted Least Squares Mean.|Mixed Models Analysis|||Adjusted for baseline diastolic blood pressure.||-1.11|-8.62|0.012
71838088|NCT03640312|143183471|SUPERIORITY||Mean Difference (Net)|-4.86|STANDARD_ERROR_OF_MEAN|1.87||0.012|TWO_SIDED|95.0|-8.62|-1.11|||Mixed Models Analysis|||||-1.11|-8.62|0.012
71838089|NCT03640312|143183472|SUPERIORITY||Odds Ratio (OR)|2.4||||0.077|TWO_SIDED|95.0|0.91|6.35|||Mixed Models Analysis|Generalized Linear Mixed Model (binomial distribution assumption with logit link).||||6.35|0.91|0.077
71838090|NCT03640312|143183473|SUPERIORITY||Odds Ratio (OR)|0.13||||0.003|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||0.48|0.03|0.003
71838091|NCT03640312|143183474|SUPERIORITY||Odds Ratio (OR)|0.8||||0.71|TWO_SIDED|95.0|0.24|2.69|||Mixed Models Analysis|||Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.||2.69|0.24|0.710
71838092|NCT03640312|143183475|SUPERIORITY||Odds Ratio (OR)|0.64||||0.437|TWO_SIDED|95.0|0.21|1.98|||Regression, Logistic|||Logistic regression model adjusting for baseline systolic and diastolic blood pressure.||1.98|0.21|0.437
71838093|NCT03640312|143183476|SUPERIORITY||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|2.01||0.09|TWO_SIDED|95.0|-7.49|0.59||Adjusted for baseline T score|ANCOVA|||Statistical test for difference in Physical Health T Score||0.59|-7.49|0.09
71671756|NCT03655405|142861366|SUPERIORITY||p-value|0.911||||0.911|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.911
71671757|NCT01445730|142861395|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71838094|NCT03640312|143183476|SUPERIORITY||Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|1.88||0.77|TWO_SIDED|95.0|-3.22|4.32||Adjusted for baseline mental health T score|ANCOVA|||Statistical test for difference in Mental Health T Score||4.32|-3.22|0.77
71838095|NCT03640312|143183477|SUPERIORITY||Mean Difference (Net)|-4.78|STANDARD_ERROR_OF_MEAN|2.97||0.114|TWO_SIDED|95.0|-10.74|1.182|||Mixed Models Analysis|||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.||1.182|-10.74|0.114
71838096|NCT03640312|143183478|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.49|TWO_SIDED|95.0|-0.15|0.02|||Fisher Exact|||||0.02|-0.15|0.49
71838097|NCT03640312|143183479|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.21|TWO_SIDED|95.0|-0.33|0.03|||Chi-squared|||||0.03|-0.33|0.21
71838098|NCT03640312|143183480|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.18|TWO_SIDED|95.0|-0.41|0.08|||Chi-squared|||||0.08|-0.41|0.18
71671758|NCT01445730|142861396|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71671759|NCT01445730|142861397|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71671760|NCT01445730|142861398|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71671761|NCT01445730|142861399|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71838099|NCT03640312|143183481|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.56|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||||0.13|-0.24|0.56
71838100|NCT03640312|143183482|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.45||0.12|TWO_SIDED|95.0|-1.61|0.19||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.19|-1.61|0.12
71838101|NCT03640312|143183483|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.95||0.94|TWO_SIDED|95.0|-1.84|1.99||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis||The model estimated mean differences, adjusted for covariates, will not be equal to the raw mean differences observed.|||1.99|-1.84|0.94
71838102|NCT03640312|143183484|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.55|TWO_SIDED|95.0|-0.07|0.04||Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.|Mixed Models Analysis|||||0.04|-0.07|0.55
71757728|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|132.7||||0.0049|TWO_SIDED|95.0|40.8|224.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.5|40.8|0.0049
71838103|NCT04709783|143183495|OTHER|One group pre-post test.|Median Difference (Final Values)|-2.67||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||.01
71671762|NCT01445730|142861400|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71757729|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|209.3|||<|0.0001|TWO_SIDED|95.0|108.3|310.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||310.3|108.3|<0.0001
71757730|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|145.7||||0.005|TWO_SIDED|95.0|44.7|246.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|44.7|0.0050
71757731|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|200.7||||0.0001|TWO_SIDED|95.0|99.7|301.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.6|99.7|0.0001
71757732|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3||||0.003|TWO_SIDED|95.0|53.3|255.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||255.3|53.3|0.0030
71757733|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|146.8||||0.0046|TWO_SIDED|95.0|45.9|247.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||247.8|45.9|0.0046
71757734|NCT01746901|143018537|SUPERIORITY_OR_OTHER||LS Mean Difference|123.3||||0.0171|TWO_SIDED|95.0|22.3|224.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||224.3|22.3|0.0171
71757735|NCT01746901|143018538|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0016|TWO_SIDED|95.0|-3.7|-0.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.9|-3.7|0.0016
71757736|NCT01746901|143018538|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0105|TWO_SIDED|95.0|0.4|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.4|0.0105
71757737|NCT01746901|143018538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7259|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.7|0.7259
71757738|NCT01746901|143018538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.7813|TWO_SIDED|95.0|-1.6|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.6|0.7813
71789589|NCT01042236|143077141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.94||0.987|TWO_SIDED|95.0|-1.91|1.94||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.94|-1.91|0.9870
71838104|NCT04709783|143183496|OTHER||Median Difference (Final Values)|-2.49||||0.01|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.01
71838105|NCT04709783|143183497|OTHER||Median Difference (Final Values)|-1.84||||0.07|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
71671763|NCT01445730|142861401|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71757739|NCT01746901|143018538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5235|TWO_SIDED|95.0|-1.9|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-1.9|0.5235
71757740|NCT01746901|143018538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8512|TWO_SIDED|95.0|-1.6|1.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.6|0.8512
71838106|NCT04709783|143183498|OTHER||Median Difference (Final Values)|-2.37||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
71838107|NCT05794243|143183506|OTHER||Ratio of Geometric Least Squares Means|0.13|||||TWO_SIDED|90.0|0.0741|0.228|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The least square means (LSMs) and differences in LSMs were back transformed to produce the ratio between geometric least square means (GLSMs).||0.228|0.0741|
71892459|NCT01381094|143306464|SUPERIORITY||||||=|0.085|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0850
71671764|NCT01465412|142861405|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.075|||||TWO_SIDED|90.0|0.695|1.662||||||The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||1.662|0.695|
71757741|NCT01746901|143018539|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0883|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0883
71757742|NCT01746901|143018539|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0241|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0241
71789590|NCT01042236|143077141|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.94||0.4167|TWO_SIDED|95.0|-2.71|1.15||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||1.15|-2.71|0.4167
71789591|NCT01042236|143077142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||0.9403|TWO_SIDED|95.0|-0.24|0.26||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.26|-0.24|0.9403
71789592|NCT01042236|143077142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.12||0.1881|TWO_SIDED|95.0|-0.42|0.09||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.09|-0.42|0.1881
71789593|NCT01042236|143077143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.8602|TWO_SIDED|95.0|-0.26|0.22||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.22|-0.26|0.8602
71789594|NCT01042236|143077143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1271|TWO_SIDED|95.0|-0.43|0.06||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.||0.06|-0.43|0.1271
71789595|NCT00227903|143077151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power||||0.88
71789596|NCT00227903|143077152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0|||||Fisher Exact|||||||0.08
71789597|NCT00227903|143077153|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0||||Not corrected for multiple comparison.|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power.||||0.88
71789598|NCT00227903|143077154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Fisher Exact|||||||0.41
71789599|NCT00227903|143077155|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.79|TWO_SIDED|95.0|0.36|1.67|||Regression, Logistic|||||1.67|0.36|0.79
71789600|NCT00227903|143077156|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.79|TWO_SIDED|95.0|0.42|2.62|||Regression, Logistic|||||2.62|0.42|0.79
71789601|NCT00227903|143077157|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.88|TWO_SIDED|95.0|0.34|2.72|||Regression, Logistic|||||2.72|0.34|0.88
71789602|NCT00227903|143077158|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.88|TWO_SIDED|95.0|0.57|2.57|||Regression, Logistic|||||2.57|0.57|0.88
71789603|NCT00227903|143077159|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77||||0.5|TWO_SIDED|95.0|0.32|1.84|||Regression, Logistic|||||1.84|0.32|0.50
71789604|NCT00227903|143077160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
71789605|NCT00227903|143077161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
71757743|NCT01746901|143018539|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0235|TWO_SIDED|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.6|2.0|0.0235
71757744|NCT01746901|143018539|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.0901|TWO_SIDED|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.9|-1.7|0.0901
71757745|NCT01746901|143018539|SUPERIORITY_OR_OTHER||LS Mean Difference|9.8||||0.1313|TWO_SIDED|95.0|-3.0|22.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.6|-3.0|0.1313
71757746|NCT01746901|143018539|SUPERIORITY_OR_OTHER||LS Mean Difference|10.8||||0.0982|TWO_SIDED|95.0|-2.0|23.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.6|-2.0|0.0982
71757747|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0351|TWO_SIDED|95.0|0.2|6.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|0.2|0.0351
71789606|NCT00227903|143077162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
71789607|NCT00227903|143077163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Mixed Models Analysis|||||||0.10
71789608|NCT00227903|143077164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.5|TWO_SIDED|95.0|0.27|2.11|||Regression, Logistic|||||2.11|0.27|0.50
71789609|NCT00227903|143077165|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.07|TWO_SIDED|95.0|0.44|3.14|||Regression, Logistic|||||3.14|0.44|0.07
71789610|NCT00227903|143077166|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.46||||0.07|TWO_SIDED|95.0|0.47|4.52|||Regression, Logistic|||||4.52|0.47|0.07
71789611|NCT00227903|143077167|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.07|TWO_SIDED|95.0|0.08|1.02|||Regression, Logistic|||||1.02|0.08|0.07
71789612|NCT00227903|143077168|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.07|TWO_SIDED|95.0|0.1|3.9|||Regression, Logistic|||||3.90|0.10|0.07
71789613|NCT00227903|143077169|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.91|TWO_SIDED|95.0|0.32|4.2|||Regression, Logistic|||||4.20|0.32|0.91
71671765|NCT01465412|142861405|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.598|||||TWO_SIDED|90.0|1.334|5.06||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.060|1.334|
71671766|NCT01465412|142861406|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.305|||||TWO_SIDED|90.0|0.84|2.027||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.027|0.840|
71789614|NCT00227903|143077170|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.91|TWO_SIDED|95.0|0.35|5.07|||Regression, Logistic|||||5.07|0.35|0.91
71789615|NCT00227903|143077171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.91|TWO_SIDED|95.0|0.14|5.23|||Regression, Logistic|||||5.23|0.14|0.91
71789616|NCT00227903|143077172|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.91|TWO_SIDED|95.0|0.21|7.12|||Regression, Logistic|||||7.12|0.21|0.91
71789617|NCT00227903|143077173|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.04|TWO_SIDED|95.0|0.46|3.55|||Regression, Logistic|||||3.55|0.46|.04
71789618|NCT00227903|143077174|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.04|TWO_SIDED|95.0|0.35|4.17|||Regression, Logistic|||||4.17|0.35|0.04
71789619|NCT00227903|143077175|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.25||||0.04|TWO_SIDED|95.0|0.04|1.63|||Regression, Logistic|||||1.63|0.04|0.04
71789620|NCT00227903|143077176|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.04|TWO_SIDED|95.0|0.04|3.74|||Regression, Logistic|||||3.74|0.04|0.04
71789621|NCT00227903|143077177|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||||||0.01
71789622|NCT00227903|143077178|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
71789623|NCT00453921|143077227|OTHER||||||<|0.04||||||For active therapy/placebo relative to both placebo|Kruskal-Wallis|||||||<0.04
71789624|NCT00453921|143077229|EQUIVALENCE|Looking for statistical difference, p \< .01, between groups looking at change scores|||||<|0.05|||||||ANOVA|||||||<0.05
71789625|NCT00453921|143077230|EQUIVALENCE|group differences|||||<|0.05|||||||ANCOVA|||||||<0.05
71789626|NCT00453921|143077233|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71789627|NCT00453921|143077233|SUPERIORITY||||||<|0.05||||||a priopr|ANCOVA|||||||<0.05
71789628|NCT03103919|143077241|SUPERIORITY||Mean Difference (Final Values)|-4.31|||=|0.134|TWO_SIDED|95.0|-10.04|1.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||1.41|-10.04|=0.134
71789629|NCT03103919|143077242|SUPERIORITY||Mean Difference (Final Values)|0.01|||=|0.982|TWO_SIDED|95.0|-0.44|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.44|=0.982
71789630|NCT03103919|143077243|SUPERIORITY||Mean Difference (Final Values)|-0.18|||=|0.566|TWO_SIDED|95.0|-0.81|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.45|-0.81|=0.566
71789631|NCT03103919|143077244|SUPERIORITY||Mean Difference (Final Values)|-0.07|||=|0.72|TWO_SIDED|95.0|-0.5|0.35|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.35|-0.50|=0.720
71789632|NCT03103919|143077245|SUPERIORITY||Mean Difference (Final Values)|0.15|||=|0.443|TWO_SIDED|95.0|-0.24|0.53|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.53|-0.24|=0.443
71789633|NCT03103919|143077246|SUPERIORITY||Mean Difference (Final Values)|-0.09|||=|0.777|TWO_SIDED|95.0|-0.75|0.57|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.57|-0.75|=0.777
71789634|NCT03103919|143077247|SUPERIORITY||Mean Difference (Final Values)|-0.01|||=|0.947|TWO_SIDED|95.0|-0.33|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.33|=0.947
71789635|NCT03103919|143077248|SUPERIORITY||Mean Difference (Final Values)|-0.27|||=|0.306|TWO_SIDED|95.0|-0.79|0.26|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.26|-0.79|=0.306
71789636|NCT03103919|143077249|SUPERIORITY||Mean Difference (Final Values)|0.03|||=|0.819|TWO_SIDED|95.0|-0.25|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).|||0.31|-0.25|=0.819
71789637|NCT03103919|143077250|SUPERIORITY||Mean Difference (Final Values)|0.07|||=|0.663|TWO_SIDED|95.0|-0.26|0.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.41|-0.26|=0.663
71789638|NCT03103919|143077251|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.197|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.||||0.11|-0.51|=0.197
71789639|NCT03103919|143077254|SUPERIORITY||Odds Ratio (OR)|1.14|||=|0.876|TWO_SIDED|95.0|0.23|5.66||P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.|Regression, Logistic||Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.|||5.66|0.23|=0.876
71789640|NCT03108027|143077272|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6096|||||TWO_SIDED|90.0|0.538|0.6811|||Mixed Models Analysis|||||0.6811|0.5380|
71789641|NCT03108027|143077272|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6152|||||TWO_SIDED|90.0|0.5437|0.6868|||Mixed Models Analysis|||||0.6868|0.5437|
71789642|NCT03108027|143077272|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.0057|||||TWO_SIDED|90.0|-0.076|0.0647|||Mixed Models Analysis|||||0.0647|-0.0760|
71789643|NCT03108027|143077273|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.6206|||||TWO_SIDED|90.0|0.5335|0.7077|||Mixed Models Analysis|||||0.7077|0.5335|
71789644|NCT03108027|143077273|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|0.7347|||||TWO_SIDED|90.0|0.6469|0.8225|||Mixed Models Analysis|||||0.8225|0.6469|
71789645|NCT03108027|143077273|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-0.1141|||||TWO_SIDED|90.0|-0.197|-0.0311|||Mixed Models Analysis|||||-0.0311|-0.1970|
71789646|NCT03108027|143077274|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|72.1|||||TWO_SIDED|90.0|61.3|82.9|||Mixed Models Analysis|||Morning average PEF||82.9|61.3|
71789647|NCT03108027|143077274|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|86.9|||||TWO_SIDED|90.0|76.1|97.8|||Mixed Models Analysis|||Morning average PEF||97.8|76.1|
71789648|NCT03108027|143077274|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|-14.8|||||TWO_SIDED|90.0|-25.6|-4.1|||Mixed Models Analysis|||Morning average PEF||-4.1|-25.6|
71789649|NCT03108027|143077274|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|73.1|||||TWO_SIDED|90.0|61.9|84.2|||Mixed Models Analysis|||Evening average PEF||84.2|61.9|
71757748|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8751|TWO_SIDED|95.0|-3.3|2.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-3.3|0.8751
71757749|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0795|TWO_SIDED|95.0|-0.3|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-0.3|0.0795
71757750|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8382|TWO_SIDED|95.0|-2.7|3.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.4|-2.7|0.8382
71789650|NCT03108027|143077274|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|58.7||||||90.0|47.5|69.9|||Mixed Models Analysis|||Evening average PEF||69.9|47.5|
71789651|NCT03108027|143077274|OTHER|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.'|Mean Difference (Net)|14.4|||||TWO_SIDED|90.0|3.3|25.5|||Mixed Models Analysis|||Evening average PEF||25.5|3.3|
71789652|NCT02574247|143077276|OTHER|||||||0.34|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -9 dB SNR||||0.34
71789653|NCT02574247|143077276|OTHER|||||||0.64|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -6 dB SNR||||0.64
71789654|NCT02574247|143077276|OTHER|||||||0.24|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -6 dB SNR||||0.24
71671767|NCT01465412|142861406|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.434|||||TWO_SIDED|90.0|0.643|3.198||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||3.198|0.643|
71671768|NCT01465412|142861407|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.852|||||TWO_SIDED|90.0|0.81|4.234||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||4.234|0.810|
71757751|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.0289|TWO_SIDED|95.0|0.4|6.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.4|0.4|0.0289
71757752|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7878|TWO_SIDED|95.0|-2.6|3.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.5|-2.6|0.7878
71757753|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|14.8||||0.0019|TWO_SIDED|95.0|5.6|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|5.6|0.0019
71757754|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.821|TWO_SIDED|95.0|-8.1|10.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.3|-8.1|0.821
71892460|NCT01381094|143306464|SUPERIORITY||||||=|0.6045|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.6045
71757755|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.0094|TWO_SIDED|95.0|3.1|21.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.5|3.1|0.0094
71892461|NCT01381094|143306464|SUPERIORITY||||||=|0.7743|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.7743
71892462|NCT01381094|143306464|SUPERIORITY||||||=|0.5326|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.5326
71892463|NCT01381094|143306464|SUPERIORITY||||||=|0.3465|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.3465
71892464|NCT01381094|143306464|SUPERIORITY||||||=|0.2756|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.2756
71671769|NCT01465412|142861407|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.392|||||TWO_SIDED|90.0|1.306|4.382||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||4.382|1.306|
71757756|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4454|TWO_SIDED|95.0|-5.6|12.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.8|-5.6|0.4454
71892465|NCT01381094|143306464|SUPERIORITY||||||=|0.1414|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1414
71757757|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|7.9||||0.0934|TWO_SIDED|95.0|-1.3|17.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.1|-1.3|0.0934
71757758|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.1358|TWO_SIDED|95.0|-2.2|16.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.2|-2.2|0.1358
71757759|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|59.8||||0.0004|TWO_SIDED|95.0|27.0|92.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||92.7|27.0|0.0004
71757760|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7||||0.2365|TWO_SIDED|95.0|-13.1|52.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||52.6|-13.1|0.2365
71757761|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0091|TWO_SIDED|95.0|11.1|76.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||76.7|11.1|0.0091
71757762|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|35.7||||0.0335|TWO_SIDED|95.0|2.8|68.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||68.5|2.8|0.0335
71757763|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8||||0.0661|TWO_SIDED|95.0|-2.1|63.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.6|-2.1|0.0661
71757764|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.1074|TWO_SIDED|95.0|-5.9|59.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.8|-5.9|0.1074
71757765|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|55.3||||0.0064|TWO_SIDED|95.0|15.8|94.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.9|15.8|0.0064
71757766|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8||||0.0543|TWO_SIDED|95.0|-0.7|78.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.3|-0.7|0.0543
71757767|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|50.2||||0.0131|TWO_SIDED|95.0|10.7|89.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.7|10.7|0.0131
71757768|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|43.9||||0.0297|TWO_SIDED|95.0|4.4|83.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.5|4.4|0.0297
71757769|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|41.3||||0.0407|TWO_SIDED|95.0|1.8|80.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.8|1.8|0.0407
71757770|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|27.5||||0.171|TWO_SIDED|95.0|-12.0|67.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.1|-12.0|0.1710
71757771|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0||||0.3362|TWO_SIDED|95.0|-106.7|36.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.7|-106.7|0.3362
71757772|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|126.9||||0.0006|TWO_SIDED|95.0|55.2|198.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.5|55.2|0.0006
71757773|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|53.2||||0.1449|TWO_SIDED|95.0|-18.5|124.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||124.8|-18.5|0.1449
71757774|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|38.7||||0.2882|TWO_SIDED|95.0|-33.0|110.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||110.4|-33.0|0.2882
71757775|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|55.0||||0.1314|TWO_SIDED|95.0|-16.6|126.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||126.7|-16.6|0.1314
71671770|NCT01465412|142861408|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.548|||||TWO_SIDED|90.0|0.918|2.61||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.610|0.918|
71789655|NCT02574247|143077276|OTHER|||||||0.2|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -3 dB SNR||||0.20
71789656|NCT02574247|143077279|OTHER|||||||0.03|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM slope||||0.03
71789657|NCT02574247|143077279|OTHER|||||||0.04|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for row IEEE slope||||0.04
71789658|NCT00268996|143077280|SUPERIORITY_OR_OTHER||Adjusted percentage change|-11.717||||0.348|TWO_SIDED|95.0|-31.995|14.607|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||14.607|-31.995|0.348
71789659|NCT00268996|143077281|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.082||||0.22|TWO_SIDED|95.0|-0.214|0.049|||ANCOVA||Difference in adjusted means is shown (Darapladib 160 mg EC tablet - Placebo).|||0.049|-0.214|0.220
71789660|NCT00268996|143077282|SUPERIORITY_OR_OTHER||Adjusted percentage change|3.977||||0.751|TWO_SIDED|95.0|-18.331|32.379|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|||32.379|-18.331|0.751
71789661|NCT00268996|143077283|SUPERIORITY_OR_OTHER||Adjusted percentage change|-60.737|||<|0.001|TWO_SIDED|95.0|-63.486|-57.78|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 26 (LOCF)||-57.780|-63.486|<0.001
71789662|NCT00268996|143077283|SUPERIORITY_OR_OTHER||Adjusted percentage change|-59.326|||<|0.001|TWO_SIDED|95.0|-62.21|-56.222|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet at Week 52 (LOCF)||-56.222|-62.210|<0.001
71892466|NCT01381094|143306464|SUPERIORITY||||||=|0.6941|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.6941
71671771|NCT01465412|142861408|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.407|||||TWO_SIDED|90.0|0.72|2.75||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.750|0.720|
71789663|NCT00268996|143077284|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.253||||0.945|TWO_SIDED|95.0|-6.998|7.504|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||7.504|-6.998|0.945
71789664|NCT00268996|143077285|SUPERIORITY_OR_OTHER||Difference in adjusted means|-0.062||||0.898|TWO_SIDED|95.0|-1.009|0.886|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||0.886|-1.009|0.898
71789665|NCT00268996|143077286|SUPERIORITY_OR_OTHER||Difference in adjusted means|-5.165||||0.012|TWO_SIDED|95.0|-9.185|-1.145|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-1.145|-9.185|0.012
71789666|NCT00268996|143077287|SUPERIORITY_OR_OTHER||Difference in adjusted means|-1.967||||0.047|TWO_SIDED|95.0|-3.912|-0.022|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).|||-0.022|-3.912|0.047
71789667|NCT00268996|143077288|SUPERIORITY_OR_OTHER||Adjusted percentage change|6.958||||0.487|TWO_SIDED|95.0|-11.568|29.364|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 26 (LOCF): Comparison between Placebo vs Darapladib 160 mg EC tablet||29.364|-11.568|0.487
71789668|NCT00268996|143077288|SUPERIORITY_OR_OTHER||Adjusted percentage change|12.255||||0.247|TWO_SIDED|95.0|-7.725|36.562|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100\]|Week 52 (LOCF): Comparison between Placebo Vs Darapladib 160 mg EC tablet||36.562|-7.725|0.247
71789669|NCT00268996|143077289|SUPERIORITY_OR_OTHER||Adjusted percentage change|-1.112||||0.687|TWO_SIDED|95.0|-6.363|4.433|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||4.433|-6.363|0.687
71789670|NCT00268996|143077289|SUPERIORITY_OR_OTHER||Adjusted percentage change|-3.237||||0.29|TWO_SIDED|95.0|-8.976|2.865|||ANOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|||2.865|-8.976|0.290
71789671|NCT00268996|143077290|SUPERIORITY_OR_OTHER||Adjusted percentage change|16.725||||0.022|TWO_SIDED|95.0|2.232|33.271|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||33.271|2.232|0.022
71789672|NCT00268996|143077290|SUPERIORITY_OR_OTHER||Adjusted percentage change|9.256||||0.252|TWO_SIDED|95.0|-6.136|27.172|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||27.172|-6.136|0.252
71789673|NCT00268996|143077291|SUPERIORITY_OR_OTHER||Adjusted percentage change|15.449||||0.196|TWO_SIDED|95.0|-7.204|43.632|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26||43.632|-7.204|0.196
71789674|NCT00268996|143077291|SUPERIORITY_OR_OTHER||Adjusted percentage change|38.567||||0.024|TWO_SIDED|95.0|4.355|83.997|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52||83.997|4.355|0.024
71789675|NCT00268996|143077292|SUPERIORITY_OR_OTHER||Adjusted percentage change|-2.098||||0.79|TWO_SIDED|95.0|-16.303|14.517|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||14.517|-16.303|0.790
71838108|NCT05794243|143183506|OTHER||Ratio of Geometric Least Squares Means|0.399|||||TWO_SIDED|90.0|0.237|0.669|||Mixed Models Analysis|||AUC (0-∞) was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.669|0.237|
71757776|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|20.1||||0.5808|TWO_SIDED|95.0|-51.6|91.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||91.8|-51.6|0.5808
71757777|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.2||||0.1415|TWO_SIDED|95.0|-154.6|22.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.3|-154.6|0.1415
71757778|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|149.1||||0.0011|TWO_SIDED|95.0|60.7|237.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||237.5|60.7|0.0011
71757779|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|52.5||||0.2423|TWO_SIDED|95.0|-35.9|140.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||140.9|-35.9|0.2423
71757780|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|30.4||||0.498|TWO_SIDED|95.0|-58.0|118.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.8|-58.0|0.4980
71757781|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|54.5||||0.2253|TWO_SIDED|95.0|-33.9|142.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.9|-33.9|0.2253
71757782|NCT01746901|143018540|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.7945|TWO_SIDED|95.0|-76.8|100.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|-76.8|0.7945
71757783|NCT01746901|143018541|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.0129|TWO_SIDED|95.0|-5.1|-0.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.6|-5.1|0.0129
71757784|NCT01746901|143018541|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0003|TWO_SIDED|95.0|2.0|6.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.5|2.0|0.0003
71757785|NCT01746901|143018541|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5483|TWO_SIDED|95.0|-1.6|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.6|0.5483
71757786|NCT01746901|143018541|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.5284|TWO_SIDED|95.0|-1.5|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-1.5|0.5284
71757787|NCT01746901|143018541|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1331|TWO_SIDED|95.0|-0.5|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-0.5|0.1331
71757788|NCT01746901|143018541|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.8732|TWO_SIDED|95.0|-2.1|2.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.4|-2.1|0.8732
71671772|NCT01465412|142861409|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.555|||||TWO_SIDED|90.0|0.617|3.917||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||3.917|0.617|
71757789|NCT01746901|143018542|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.4555|TWO_SIDED|95.0|-5.9|13.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-5.9|0.4555
71757790|NCT01746901|143018542|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.1495|TWO_SIDED|95.0|-2.5|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-2.5|0.1495
71757791|NCT01746901|143018542|SUPERIORITY_OR_OTHER||LS Mean Difference|11.4||||0.02|TWO_SIDED|95.0|1.8|20.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|1.8|0.0200
71838109|NCT05794243|143183508|OTHER||Ratio of Geometric Least Squares Means|0.106|||||TWO_SIDED|90.0|0.062|0.182|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.182|0.0620|
71757792|NCT01746901|143018542|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.8668|TWO_SIDED|95.0|-10.3|8.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.7|-10.3|0.8668
71757793|NCT01746901|143018542|SUPERIORITY_OR_OTHER||LS Mean Difference|4.1||||0.3904|TWO_SIDED|95.0|-5.3|13.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.6|-5.3|0.3904
71757794|NCT01746901|143018542|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.6524|TWO_SIDED|95.0|-7.3|11.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|-7.3|0.6524
71838110|NCT05794243|143183508|OTHER||Ratio of Geometric Least Squares Means|0.343|||||TWO_SIDED|90.0|0.206|0.569|||Mixed Models Analysis|||Cmax was log-transformed and analyzed via mixed model for repeated measures with fixed effects for treatment, profile day and the treatment-by-day interaction, and a random effect for participant. The LSMs and differences in LSMs were back transformed to produce the ratio between GLSMs.||0.569|0.206|
71671773|NCT01465412|142861409|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.806|||||TWO_SIDED|90.0|2.77|8.335||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||8.335|2.770|
71677214|NCT04143594|142873011|SUPERIORITY||Difference in LSM|-2.0||||0.9549|TWO_SIDED|95.0|-79.0|75.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||75|-79|0.9549
71757795|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1771|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1771
71757796|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.3944|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3944
71757797|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.1778|TWO_SIDED|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.1|-0.4|0.1778
71757798|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.396|TWO_SIDED|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-1.7|0.3960
71757799|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.6125|TWO_SIDED|95.0|-0.9|1.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-0.9|0.6125
71757800|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.9059|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.3|-1.1|0.9059
71757801|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.4585|TWO_SIDED|95.0|-2.9|6.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.3|-2.9|0.4585
71757802|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.8986|TWO_SIDED|95.0|-4.2|4.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.8|-4.2|0.8986
71757803|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.3641|TWO_SIDED|95.0|-2.5|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.5|0.3641
71789676|NCT00268996|143077292|SUPERIORITY_OR_OTHER||Adjusted percentage change|1.986||||0.818|TWO_SIDED|95.0|-13.807|20.673|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||20.673|-13.807|0.818
71789677|NCT00268996|143077293|SUPERIORITY_OR_OTHER||Adjusted percentage change|-0.252||||0.98|TWO_SIDED|95.0|-18.151|21.561|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)||21.561|-18.151|0.980
71757804|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.9674|TWO_SIDED|95.0|-4.6|4.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|-4.6|0.9674
71789678|NCT00268996|143077293|SUPERIORITY_OR_OTHER||Adjusted percentage change|-8.585||||0.663|TWO_SIDED|95.0|-39.007|37.012|||ANCOVA||Adjusted percentage change is shown \[(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100\]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)||37.012|-39.007|0.663
71789679|NCT00268996|143077295|SUPERIORITY_OR_OTHER||Adjusted treatment Difference|1.758||||0.811|TWO_SIDED|95.0|-12.675|16.192|||ANCOVA||Difference in adjusted means are shown (Darapladib 160mg EC tablet once daily - Placebo).|For vessel volume||16.192|-12.675|0.811
71838111|NCT02761057|143183527|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.019|TWO_SIDED|95.0|0.37|0.97|||Regression, Cox|||A proportional hazards model was used to compare the Hazard Ratio (HR) for PFS.||0.97|0.37|0.019
71757805|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.5744|TWO_SIDED|95.0|-3.2|5.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-3.2|0.5744
71757806|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.3457|TWO_SIDED|95.0|-2.4|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.7|-2.4|0.3457
71838112|NCT02761057|143183528|SUPERIORITY|||||||0.1|||||||Chi-squared|||The Chi-Square test will be used to compare RR between sunitinib and cabozantinib.||||0.10
71838113|NCT02761057|143183529|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.47|1.51|||Log Rank|||The log-rank test will be used to compare OS.||1.51|0.47|
71838114|NCT05492318|143183554|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|105.67|||||TWO_SIDED|90.0|91.72|121.74||||||"Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV.~Cmax"||121.74|91.72|
71757807|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.6664|TWO_SIDED|95.0|-13.3|20.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.8|-13.3|0.6664
71757808|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.1949|TWO_SIDED|95.0|-5.8|28.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.0|-5.8|0.1949
71757809|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|11.1||||0.2009|TWO_SIDED|95.0|-6.0|28.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.1|-6.0|0.2009
71757810|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8||||0.6595|TWO_SIDED|95.0|-13.1|20.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.7|-13.1|0.6595
71757811|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.3176|TWO_SIDED|95.0|-8.3|25.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.5|-8.3|0.3176
71757812|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0||||0.6423|TWO_SIDED|95.0|-12.9|20.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.9|-12.9|0.6423
71757813|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.4358|TWO_SIDED|95.0|-10.5|24.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.2|-10.5|0.4358
71757814|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7||||0.1789|TWO_SIDED|95.0|-5.4|28.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.9|-5.4|0.1789
71892467|NCT01381094|143306464|SUPERIORITY||||||=|0.9403|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.9403
71757815|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|14.0||||0.1131|TWO_SIDED|95.0|-3.3|31.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.3|-3.3|0.1131
71757816|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.5965|TWO_SIDED|95.0|-12.6|21.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.8|-12.6|0.5965
71757817|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.3175|TWO_SIDED|95.0|-8.5|25.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.9|-8.5|0.3175
71757818|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.6551|TWO_SIDED|95.0|-13.3|21.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||21.0|-13.3|0.6551
71757819|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3||||0.0354|TWO_SIDED|95.0|-87.5|-3.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.1|-87.5|0.0354
71757820|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|55.2||||0.01|TWO_SIDED|95.0|13.4|97.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||97.0|13.4|0.0100
71757821|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.5379|TWO_SIDED|95.0|-29.0|55.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||55.4|-29.0|0.5379
71757822|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3||||0.8768|TWO_SIDED|95.0|-45.1|38.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-45.1|0.8768
71757823|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.7031|TWO_SIDED|95.0|-33.8|49.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.9|-33.8|0.7031
71892468|NCT01381094|143306464|SUPERIORITY||||||=|0.831|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.8310
71757824|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.8507|TWO_SIDED|95.0|-45.8|37.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.8|-45.8|0.8507
71757825|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.3||||0.0381|TWO_SIDED|95.0|-121.2|-3.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.5|-121.2|0.0381
71757826|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|64.0||||0.0318|TWO_SIDED|95.0|5.7|122.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||122.3|5.7|0.0318
71757827|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|15.2||||0.6095|TWO_SIDED|95.0|-43.6|74.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||74.1|-43.6|0.6095
71838115|NCT05492318|143183554|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric least square mean|91.56|||||TWO_SIDED|90.0|86.16|97.31||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||97.31|86.16|
71838116|NCT05492318|143183554|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|92.13|||||TWO_SIDED|90.0|75.97|111.73||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||111.73|75.97|
71671774|NCT01465412|142861410|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.269|||||TWO_SIDED|90.0|0.703|2.288||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.288|0.703|
71671775|NCT01465412|142861410|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.98|||||TWO_SIDED|90.0|1.316|2.977||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||2.977|1.316|
71671776|NCT01465412|142861411|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.326|||||TWO_SIDED|90.0|0.749|2.348||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.348|0.749|
71789680|NCT00268996|143077295|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.627||||0.708|TWO_SIDED|95.0|-11.171|16.425|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet once daily - Placebo).|For lumen volume||16.425|-11.171|0.708
71789681|NCT00268996|143077296|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.012||||0.873|TWO_SIDED|95.0|-0.16|0.136||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.136|-0.160|0.873
71789682|NCT00268996|143077296|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.048||||0.756|TWO_SIDED|95.0|-0.258|0.354|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area||0.354|-0.258|0.756
71789683|NCT00268996|143077296|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.061||||0.687|TWO_SIDED|95.0|-0.237|0.36|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean lumen area||0.360|-0.237|0.687
71789684|NCT00268996|143077297|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-0.584||||0.854|TWO_SIDED|95.0|-6.819|5.65|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue volume||5.650|-6.819|0.854
71789685|NCT00268996|143077297|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.926||||0.418|TWO_SIDED|95.0|-2.748|6.6||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty volume||6.600|-2.748|0.418
71789686|NCT00268996|143077298|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.0||||0.021|TWO_SIDED|95.0|0.299|3.701|||ANOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue as % of VH plaque||3.701|0.299|0.021
71789687|NCT00268996|143077298|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.739||||0.54|TWO_SIDED|95.0|-1.635|3.114|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty as percentage of VH plaque||3.114|-1.635|0.540
71789688|NCT01340898|143077308|SUPERIORITY_OR_OTHER||Percentage of subjects|100.0|||||TWO_SIDED|95.0|98.9|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.9|
71789689|NCT01340898|143077308|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants.||100|98.3|
71789690|NCT01340898|143077308|SUPERIORITY_OR_OTHER||Percentage of subjects|99.4|||||TWO_SIDED|95.0|97.8|99.9|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup W-135 one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||99.9|97.8|
71838117|NCT05492318|143183554|OTHER|please note that GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|93.59|||||TWO_SIDED|90.0|83.72|104.63||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - Cmax||104.63|83.72|
71838118|NCT05492318|143183554|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|124.02|||||TWO_SIDED|90.0|114.38|134.47||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||134.47|114.38|
71838119|NCT05492318|143183554|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|117.47|||||TWO_SIDED|90.0|104.78|131.69||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Max||131.69|104.78|
71838120|NCT05492318|143183554|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|139.28|||||TWO_SIDED|90.0|128.71|150.67||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||150.67|128.71|
71838121|NCT05492318|143183554|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of geometric LS means|141.61|||||TWO_SIDED|90.0|122.36|163.88||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - Cmax||163.88|122.36|
71838122|NCT05492318|143183555|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.68|||||TWO_SIDED|90.0|60.77|89.33||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||89.33|60.77|
71838123|NCT05492318|143183555|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.38|||||TWO_SIDED|90.0|57.94|85.5||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||85.50|57.94|
71838124|NCT05492318|143183555|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|65.31|||||TWO_SIDED|90.0|53.33|79.98||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - Cmax||79.98|53.33|
71838125|NCT05492318|143183555|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|62.18|||||TWO_SIDED|90.0|50.86|75.95||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. Cmax||75.95|50.86|
71838126|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the geometric LS means|107.35|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.49|103.35|
71838127|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|106.18|||||TWO_SIDED|90.0|100.84|111.8||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||111.80|100.84|
71838128|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|121.77|||||TWO_SIDED|90.0|117.56|126.12||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||126.12|117.56|
71892469|NCT01381094|143306464|SUPERIORITY||||||=|0.0654|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0654
71838129|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|122.97|||||TWO_SIDED|90.0|115.08|131.41||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-t||131.41|115.08|
71838130|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|137.42|||||TWO_SIDED|90.0|128.09|147.43||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||147.43|128.09|
71838131|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|131.21|||||TWO_SIDED|90.0|122.47|140.59||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-t||140.59|122.47|
71892470|NCT01381094|143306464|SUPERIORITY||||||=|0.4169|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.4169
71892471|NCT01381094|143306464|SUPERIORITY||||||=|0.0103|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0103
71892472|NCT01381094|143306464|SUPERIORITY||||||=|0.3968|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.3968
71671777|NCT01465412|142861411|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|4.041|||||TWO_SIDED|90.0|1.46|11.187||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||11.187|1.460|
71671778|NCT01465412|142861412|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|1.609|||||TWO_SIDED|90.0|1.007|2.572||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.||2.572|1.007|
71671779|NCT01465412|142861412|NON_INFERIORITY_OR_EQUIVALENCE|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval \[0.50, 2.00\].|LSM Ratio|2.231|||||TWO_SIDED|90.0|0.844|5.896||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.||5.896|0.844|
71757828|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.6||||0.647|TWO_SIDED|95.0|-71.9|44.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||44.8|-71.9|0.6470
71757829|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0||||0.8136|TWO_SIDED|95.0|-51.4|65.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.4|-51.4|0.8136
71757830|NCT01746901|143018543|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.6||||0.6699|TWO_SIDED|95.0|-71.0|45.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.7|-71.0|0.6699
71757831|NCT01746901|143018544|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1728|TWO_SIDED|95.0|-3.9|0.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.7|-3.9|0.1728
71757832|NCT01746901|143018544|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.2616|TWO_SIDED|95.0|-1.0|3.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.6|-1.0|0.2616
71757833|NCT01746901|143018544|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7307|TWO_SIDED|95.0|-1.9|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-1.9|0.7307
71757834|NCT01746901|143018544|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5473|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5473
71757835|NCT01746901|143018544|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.4999|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.1|0.4999
71671780|NCT04390113|142861413|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6253|TWO_SIDED|95.0|0.55|1.55|||Log Rank|||||1.55|0.55|0.6253
71671781|NCT00030901|142861421|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is adjusted for stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.|Regression, Logistic|||With target sample size of 466 randomized patients (233 per arm), there is a 90% of power to detect a one-third reduction in the three-year incidence rate of prostate cancer. The alpha level is set at 0.025, one-sided.||||0.73
71757836|NCT01746901|143018544|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.5592|TWO_SIDED|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-3.0|0.5592
71671782|NCT01205776|142861427|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Hazard Ratio (HR)|-3.1|||<|0.0001|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Com-Nougue|||||||<0.0001
71757837|NCT01746901|143018545|SUPERIORITY_OR_OTHER||LS Mean Difference|13.3||||0.0217|TWO_SIDED|95.0|2.0|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.6|2.0|0.0217
71757838|NCT01746901|143018545|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.5513|TWO_SIDED|95.0|-7.8|14.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.6|-7.8|0.5513
71757839|NCT01746901|143018545|SUPERIORITY_OR_OTHER||LS Mean Difference|11.5||||0.0469|TWO_SIDED|95.0|0.2|22.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.8|0.2|0.0469
71757840|NCT01746901|143018545|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.3604|TWO_SIDED|95.0|-6.0|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|-6.0|0.3604
71757841|NCT01746901|143018545|SUPERIORITY_OR_OTHER||LS Mean Difference|6.2||||0.2725|TWO_SIDED|95.0|-5.0|17.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|-5.0|0.2725
71757842|NCT01746901|143018545|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4||||0.3461|TWO_SIDED|95.0|-5.8|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.6|-5.8|0.3461
71671783|NCT01205776|142861439|NON_INFERIORITY|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Hazard Ratio (HR)|4.0||||0.011|TWO_SIDED|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Com-Nougue Approach|||||||0.011
71671784|NCT03817190|142861522|SUPERIORITY||Proportion of participants|-0.2277||||0.688|TWO_SIDED|95.0|-1.0415|0.586|||GLMM|||||0.5860|-1.0415|0.6880
71757843|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1828|TWO_SIDED|95.0|-1.1|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.8|-1.1|0.1828
71757844|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5||||0.3908|TWO_SIDED|95.0|-5.0|1.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.9|-5.0|0.3908
71757845|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.2513|TWO_SIDED|95.0|-1.5|5.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.5|-1.5|0.2513
71757846|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.5035|TWO_SIDED|95.0|-4.6|2.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-4.6|0.5035
71757847|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.1452|TWO_SIDED|95.0|-0.9|6.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.0|-0.9|0.1452
71757848|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.9303|TWO_SIDED|95.0|-3.6|3.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-3.6|0.9303
71757849|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8||||0.0283|TWO_SIDED|95.0|0.9|16.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.7|0.9|0.0283
71757850|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7||||0.4861|TWO_SIDED|95.0|-10.5|5.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-10.5|0.4861
71757851|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|5.3||||0.1809|TWO_SIDED|95.0|-2.5|13.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.2|-2.5|0.1809
71757852|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.856|TWO_SIDED|95.0|-7.1|8.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.5|-7.1|0.8560
71838132|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|157.77|||||TWO_SIDED|90.0|147.49|168.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam. - AUC0-t||168.76|147.49|
71838133|NCT05492318|143183560|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|158.3|||||TWO_SIDED|90.0|145.23|172.54||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: - AUC0-t||172.54|145.23|
71671785|NCT03817190|142861523|SUPERIORITY||Proportion of participants|-0.276||||0.4321|TWO_SIDED|95.0|-0.9185|0.3665|||GLMM|||||0.3665|-0.9185|0.4321
71892473|NCT01381094|143306464|SUPERIORITY||||||=|0.0325|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0325
71757853|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.2385|TWO_SIDED|95.0|-3.1|12.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.4|-3.1|0.2385
71892474|NCT01381094|143306464|SUPERIORITY||||||=|0.2151|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2151
71757854|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7||||0.3479|TWO_SIDED|95.0|-4.1|11.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.5|-4.1|0.3479
71757855|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|27.7||||0.0185|TWO_SIDED|95.0|4.7|50.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||50.6|4.7|0.0185
71757856|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.5471|TWO_SIDED|95.0|-15.8|29.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||29.7|-15.8|0.5471
71892475|NCT01381094|143306464|SUPERIORITY||||||=|0.8436|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.8436
71892476|NCT01381094|143306464|SUPERIORITY||||||=|0.5962|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5962
71757857|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5||||0.0367|TWO_SIDED|95.0|1.5|47.4|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||47.4|1.5|0.0367
71671786|NCT00437021|142861535|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.97|1.99|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||1.99|0.97|
71757858|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|10.1||||0.3797|TWO_SIDED|95.0|-12.6|32.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.9|-12.6|0.3797
71757859|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|16.4||||0.1557|TWO_SIDED|95.0|-6.3|39.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.1|-6.3|0.1557
71789691|NCT01340898|143077308|SUPERIORITY_OR_OTHER||Percentage of subjects|99.7|||||TWO_SIDED|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup Y one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants||100|98.3|
71671787|NCT00437021|142861536|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.895|||||TWO_SIDED|95.0|2.22|3.69|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.69|2.22|
71757860|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2||||0.2904|TWO_SIDED|95.0|-10.5|34.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.9|-10.5|0.2904
71757861|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|26.0||||0.0467|TWO_SIDED|95.0|0.4|51.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.6|0.4|0.0467
71757862|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|10.7||||0.4056|TWO_SIDED|95.0|-14.6|36.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||36.0|-14.6|0.4056
71671788|NCT00437021|142861544|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|1.65|2.76|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||2.76|1.65|
71671789|NCT00437021|142861545|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group A is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|3.08|||||TWO_SIDED|95.0|2.57|3.59|||||Estimate and corresponding 95% confidence interval are calculated on the log2 scale.|Null hypothesis: The mean difference in log2 transformed titers between Group B and Group A \>= 1.||3.59|2.57|
71757863|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|23.3||||0.0738|TWO_SIDED|95.0|-2.3|48.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.9|-2.3|0.0738
71757864|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4||||0.2987|TWO_SIDED|95.0|-12.0|38.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.7|-12.0|0.2987
71838134|NCT05492318|143183561|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.9|||||TWO_SIDED|90.0|58.43|83.64||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics - AUC0-t||83.64|58.43|
71838135|NCT05492318|143183561|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.43|||||TWO_SIDED|90.0|58.67|86.98||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||86.98|58.67|
71757865|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0763|TWO_SIDED|95.0|-2.4|48.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.2|-2.4|0.0763
71757866|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|12.3||||0.3396|TWO_SIDED|95.0|-13.1|37.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||37.6|-13.1|0.3396
71757867|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2||||0.2425|TWO_SIDED|95.0|-89.1|22.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||22.7|-89.1|0.2425
71757868|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1||||0.0281|TWO_SIDED|95.0|6.8|117.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||117.5|6.8|0.0281
71838136|NCT05492318|143183561|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.94|||||TWO_SIDED|90.0|58.82|83.15||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||83.15|58.82|
71671790|NCT00607620|142861604|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||||0.98|0.79|
71757869|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.4189|TWO_SIDED|95.0|-33.0|78.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||78.8|-33.0|0.4189
71757870|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.831|TWO_SIDED|95.0|-49.4|61.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||61.4|-49.4|0.8310
71757871|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|34.8||||0.2161|TWO_SIDED|95.0|-20.6|90.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.1|-20.6|0.2161
71757872|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9||||0.8905|TWO_SIDED|95.0|-51.5|59.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.2|-51.5|0.8905
71757873|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8||||0.1597|TWO_SIDED|95.0|-124.2|20.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||20.6|-124.2|0.1597
71757874|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|70.9||||0.0525|TWO_SIDED|95.0|-0.8|142.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||142.6|-0.8|0.0525
71757875|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|23.1||||0.5294|TWO_SIDED|95.0|-49.3|95.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||95.4|-49.3|0.5294
71838137|NCT05492318|143183561|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|72.3|||||TWO_SIDED|90.0|59.92|87.25||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-t||87.25|59.92|
71838138|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|107.55|||||TWO_SIDED|90.0|103.35|111.49||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV: AUC0-inf||111.49|103.35|
71671791|NCT00607620|142861605|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3|||||The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.|||-0.3|-2.1|
71789692|NCT02056340|143077343|OTHER|||||||0.611||||||Threshold for significaance was p value \<0.05.|Mixed Models Analysis|||We used a linear mixed-effects model which accounted for all measurements taken and the time that those measurements were taken.||||0.611
71789693|NCT02056340|143077344|OTHER|||||||0.029||||||P value reflects baseline to 72 hours between groups. A p-value \<0.05 will be considered significant.|Mixed Models Analysis|||The primary comparison was at 72 hours for the self-reported influenza severity score.||||0.029
71789694|NCT02669433|143077372|SUPERIORITY||Mean Difference (Final Values)|-2.01||||0.158|TWO_SIDED|95.0|-4.8|0.79||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.79|-4.80|0.158
71789695|NCT02669433|143077372|SUPERIORITY||Mean Difference (Final Values)|0.74||||0.6069|TWO_SIDED|95.0|-2.08|3.55||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||3.55|-2.08|0.6069
71789696|NCT02669433|143077373|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.6531|TWO_SIDED|95.0|-2.55|1.6|||Mixed Models Analysis||Placebo - active|||1.60|-2.55|0.6531
71789697|NCT02669433|143077373|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.5274|TWO_SIDED|95.0|-1.41|2.75||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||2.75|-1.41|0.5274
71789698|NCT02669433|143077374|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3953|TWO_SIDED|95.0|-0.2|0.5||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.5|-0.2|0.3953
71789699|NCT02669433|143077374|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7008|TWO_SIDED|95.0|-0.28|0.42||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active|||0.42|-0.28|0.7008
71789700|NCT00576927|143077376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.655|TWO_SIDED|95.0|0.156|8.717||p-value suspect because of sparse cell counts|Chi-squared|||||8.717|0.156|0.655
71838139|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|112.17|||||TWO_SIDED|90.0|106.21|118.46||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||118.46|106.21|
71838140|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|124.01|||||TWO_SIDED|90.0|119.44|128.76||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV - AUC0-inf||128.76|119.44|
71838141|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Midazolam IV Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Midazolam of IV Alone (Day 1)|ratio of the Geometric LSmeans|134.29|||||TWO_SIDED|90.0|126.15|142.96||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Midazolam IV. AUC0-inf||142.96|126.15|
71838142|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 7) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|138.75|||||TWO_SIDED|90.0|129.05|149.18||||||Midazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||149.18|129.05|
71838143|NCT05492318|143183562|OTHER||GMR corresponds to the ratio of the Geom|134.18|||||TWO_SIDED|90.0|124.19|144.97||||||1-Hydroxymidazolam: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||144.97|124.19|
71838144|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|162.76|||||TWO_SIDED|90.0|151.13|175.28||||||Midazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam: AUC0-inf||175.28|151.13|
71838145|NCT05492318|143183562|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Oral Midazolam Co-Administered with Givinostat (Day 18) and the Geometric LSmeans of Oral Midazolam Alone (Day 2)|ratio of the Geometric LSmeans|161.2|||||TWO_SIDED|90.0|147.8|175.82||||||1-Hydroxymidazolam: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Oral Midazolam - AUC0-inf||175.82|147.80|
71671792|NCT00607620|142861606|SUPERIORITY||Mean Difference (Net)|3.4|||||TWO_SIDED|95.0|0.4|6.4|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||6.4|0.4|
71671793|NCT00607620|142861607|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.3|1.9|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||1.9|-3.3|
71789701|NCT02157298|143077419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1053|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.39|-0.81|<0.0001
71789702|NCT02157298|143077420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|5.301|<|0.0001|TWO_SIDED|95.0|-33.2|-12.2||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-12.2|-33.2|<0.0001
71789703|NCT02157298|143077421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.255|<|0.0001|TWO_SIDED|95.0|-1.7|-0.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||-0.7|-1.7|<0.0001
71671794|NCT00607620|142861608|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-1.02|0.99|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.|||0.99|-1.02|
71757876|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.0||||0.9126|TWO_SIDED|95.0|-75.7|67.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.7|-75.7|0.9126
71757877|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|34.6||||0.3418|TWO_SIDED|95.0|-37.1|106.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||106.3|-37.1|0.3418
71789704|NCT02157298|143077422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.4017||0.0743|TWO_SIDED|95.0|-1.51|0.07||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0||0.07|-1.51|0.0743
71789705|NCT02157298|143077423|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4|STANDARD_ERROR_OF_MEAN|3.769||0.3727|TWO_SIDED|95.0|-4.0|10.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsitatis, Davidian, Zhang \& Lu, with adjustment with adjustment for baseline value and DPP-4||H0: proportion(dapa) minus proportion(placebo) = 0 versus alternative HA: proportion(dapa) minus proportion(placebo) =/= 0||10.7|-4.0|0.3727
71789706|NCT03171415|143077427|SUPERIORITY||||||>|0.05|TWO_SIDED|5.0|||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||>0.05
71789707|NCT03171415|143077427|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups, at day 28 and Day 56||||<0.05
71789708|NCT03171415|143077427|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
71789709|NCT03171415|143077427|SUPERIORITY||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups||||<0.05
71789710|NCT03171415|143077428|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71789711|NCT03171415|143077428|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71892477|NCT01381094|143306464|SUPERIORITY||||||=|0.3957|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.3957
71671795|NCT01620138|142861609|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71671796|NCT03907488|142861615|SUPERIORITY||||||<|0.005||||||One sided P-value|Log Rank|||The primary analysis of PFS used a stratified log rank test statistic and is reported as two-sided test. Stratified Cox regression was used to estimate treatment hazard ratios for treatment effect. 95% two-sided intervals are reported. The Kaplan-Meier method was used to estimate PFS curves.||||<0.005
71671797|NCT01766076|142861625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Mann Whitney test was used for nonparametric variables||||||<0.05
71789712|NCT03171415|143077428|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71789713|NCT03171415|143077428|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71789714|NCT03171415|143077434|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71789715|NCT04059094|143077436|OTHER||Adjusted means difference|1.5|STANDARD_ERROR_OF_MEAN|2.45||0.5468|TWO_SIDED|95.0|-3.5|6.5|||Mixed model with repeated measurements||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|Mixed Model for Repeated Measures (MMRM) with fixed effects for baseline, visit, treatment, treatment-by-visit interaction, baseline-by-visit interaction, and random effect for patient was applied. No hypothesis testing was performed, as this trial was prematurely discontinued. MMRM only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-3.5|0.5468
71789716|NCT04059094|143077437|OTHER||Adjuste means difference|2.1|STANDARD_ERROR_OF_MEAN|1.83||0.3039|TWO_SIDED|95.0|-2.4|6.5|||ANCOVA||Adjusted means difference was calculated as value from BI 1265162 200μg minus value from placebo group.|ANCOVA based on analysis of covariance with fixed effects for baseline and treatment was applied. Statistical analysis was performed for 200μg BI and placebo groups only. No hypothesis testing was performed, as this trial was prematurely discontinued. ANCOVA only included data from 200µg BI and placebo, as the sample size of the BI 20µg, BI 50µg and BI 100µg dose levels was limited because of the premature discontinuation of the trial.||6.5|-2.4|0.3039
71789717|NCT03715764|143077450|SUPERIORITY|||||||0.87||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.87
71789718|NCT03715764|143077450|SUPERIORITY||||||<|0.001||||||Results for the final model for the variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||<0.001
71789719|NCT03715764|143077450|SUPERIORITY|||||||0.18||||||Results for the final model, variable Group x Time (Statistical interaction of group and time), adjusted for confounders.|Mixed Models Analysis|||||||0.18
71789720|NCT03715764|143077451|SUPERIORITY|||||||0.56||||||Results for the final model, variable GROUP, adjusted for confounders.|Mixed Models Analysis|||||||0.56
71789721|NCT03715764|143077451|SUPERIORITY|||||||0.0049||||||Results for the final model, variable TIME, adjusted for confounders.|Mixed Models Analysis|||||||0.0049
71757878|NCT01746901|143018546|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.8833|TWO_SIDED|95.0|-77.0|66.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.4|-77.0|0.8833
71757879|NCT01746901|143018547|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6||||0.0041|TWO_SIDED|95.0|-6.1|-1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.2|-6.1|0.0041
71789722|NCT03715764|143077451|SUPERIORITY|||||||0.49||||||Results for the final model, adjusted for confounders, for the variable Group x Time (Statistical interaction of group and time).|Mixed Models Analysis|||||||0.49
71789723|NCT03715764|143077452|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
71789724|NCT03715764|143077453|SUPERIORITY|Used as a confounder in the mixed effect model analysis for primary outcome. All participants enrolled in the study were included in the 12 months analysis.|||||<|0.2||||||Confounding variables with p-values \< 0.2 were carried forward to the final model.|Mixed Models Analysis|||||||<0.2
71789725|NCT01338493|143077459|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71789726|NCT01338493|143077460|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71789727|NCT00775645|143077497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.17|TWO_SIDED|95.0|-2.2|0.4|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||0.4|-2.2|0.17
71789728|NCT00775645|143077498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.92|TWO_SIDED|95.0|-3.0|2.7|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||2.7|-3|0.92
71789729|NCT00775645|143077499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2|TWO_SIDED|95.0|-0.7|3.3|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.||||3.3|-0.7|0.20
71789730|NCT00775645|143077500|SUPERIORITY|||||||0.46|||||||Regression, Linear|Adjusted for randomization stratification factors.||||||0.46
71789731|NCT03388294|143077509|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|7.32||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
71789732|NCT03388294|143077510|OTHER||Mean Difference (Net)|12.75|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||The focus for this analysis is change over time||||<0.001
71789733|NCT03388294|143077511|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||||||0.87
71789734|NCT03388294|143077512|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.61||||0.006|TWO_SIDED||||||Mixed Models Analysis|||||||0.006
71789735|NCT03388294|143077513|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|||||||0.76
71789736|NCT03388294|143077514|OTHER|The focus for this analysis is change over time||||||0.849|||||||Mixed Models Analysis|||||||0.849
71789737|NCT03388294|143077515|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.2||||0.063|TWO_SIDED||||||Mixed Models Analysis|||||||0.063
71789738|NCT03388294|143077516|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.48|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71789739|NCT03388294|143077520|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|-2.9||||0.036|TWO_SIDED||||||Mixed Models Analysis|||||||0.036
71789740|NCT03388294|143077521|OTHER|The focus for this analysis is change over time||||||0.0002|||||||Mixed Models Analysis|||||||0.0002
71789741|NCT03388294|143077522|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.36||||0.864|TWO_SIDED||||||Mixed Models Analysis|||||||0.864
71789742|NCT03388294|143077523|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|3.14||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71789743|NCT03388294|143077524|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.881|TWO_SIDED||||||Mixed Models Analysis|||||||0.881
71789744|NCT03388294|143077525|OTHER|The focus for this analysis is change over time|Mean Difference (Net)|0.02||||0.846|TWO_SIDED||||||Mixed Models Analysis|||||||0.846
71789745|NCT03143569|143077533|OTHER|||||||0.45|||||||Fisher Exact|||||||.45
71789746|NCT03143569|143077534|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71838146|NCT05492318|143183563|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|69.96|||||TWO_SIDED|90.0|58.83|83.2||||||Total Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.20|58.83|
71789747|NCT03143569|143077535|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71789748|NCT03143569|143077536|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71789749|NCT03143569|143077537|OTHER|||||||0.018|||||||Chi-squared|||||||.018
71789750|NCT01031069|143077553|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-16 type.|Adjusted GMT ratio|2.95|||||TWO_SIDED|95.0|1.92|4.52||||||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.52|1.92|
71789751|NCT01031069|143077553|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (\>) 0.5 for HPV-18 type.|Adjusted GMT ratio|7.83|||||TWO_SIDED|95.0|4.84|12.66||||||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|12.66|4.84|
71813323|NCT01181726|143129080|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.33|||||TWO_SIDED|90.0|92.21|107.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.00|92.21|
71789752|NCT01031069|143077554|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.|Adjusted GMT ratio|7.44|||<|0.0001|TWO_SIDED|95.0|4.79|11.54|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|11.54|4.79|<0.0001
71789753|NCT01031069|143077554|SUPERIORITY|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.|Adjusted GMT ratio|2.74|||<|0.0001|TWO_SIDED|95.0|1.83|4.11|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.|4.11|1.83|<0.0001
71789754|NCT01031069|143077571|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|5.38|||<|0.0001|TWO_SIDED|97.5|3.2|9.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||9.06|3.20|<0.0001
71838147|NCT05492318|143183563|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 6) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|71.65|||||TWO_SIDED|90.0|59.08|86.88||||||Free Dabigatran: Potential Inhibitory Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||86.88|59.08|
71838148|NCT05492318|143183563|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric LSmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|70.37|||||TWO_SIDED|90.0|59.64|83.03||||||Total Dabigatran: Potential Inducing Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate - AUC0-inf||83.03|59.64|
71671798|NCT01611883|142861652|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe treatment group will be considered non-inferior to the placebo control group if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference (ezetimibe minus placebo) in means for change in HbA1c from baseline to the end of treatment does not exceed 0.5%.|Difference in Least-squares Means|0.08|||||TWO_SIDED|95.0|-0.07|0.23|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||0.23|-0.07|
71892478|NCT01381094|143306465|SUPERIORITY||||||=|0.0294|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0294
71892479|NCT01381094|143306465|SUPERIORITY||||||=|0.0021|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0021
71892480|NCT01381094|143306465|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0004
71892481|NCT01381094|143306465|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0001
71892482|NCT01381094|143306465|SUPERIORITY||||||=|0.0925|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0925
71892483|NCT01381094|143306465|SUPERIORITY||||||=|0.0433|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0433
71892484|NCT01381094|143306465|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
71892485|NCT01381094|143306465|SUPERIORITY||||||=|0.0005|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0005
71892486|NCT01381094|143306465|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
71671799|NCT01611883|142861653|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|95.0|-0.47|0.47|||Longitudinal analysis of covariance||ezetimibe minus placebo|||0.47|-0.47|
71671800|NCT01611883|142861654|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-4.8|||||TWO_SIDED|95.0|-12.1|2.5|||Longitudinal Analysis of Covariance||ezetimibe minus placebo|||2.5|-12.1|
71671801|NCT01611883|142861655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.779
71757880|NCT01746901|143018547|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0006|TWO_SIDED|95.0|1.9|6.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.8|1.9|0.0006
71757881|NCT01746901|143018547|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8765|TWO_SIDED|95.0|-2.7|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-2.7|0.8765
71757882|NCT01746901|143018547|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.4746|TWO_SIDED|95.0|-1.6|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|-1.6|0.4746
71757883|NCT01746901|143018547|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.4607|TWO_SIDED|95.0|-3.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.5|-3.3|0.4607
71757884|NCT01746901|143018547|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.2316|TWO_SIDED|95.0|-1.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|-1.0|0.2316
71757885|NCT01746901|143018548|SUPERIORITY_OR_OTHER||LS Mean Difference|38.8|||<|0.0001|TWO_SIDED|95.0|26.4|51.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||51.3|26.4|<0.0001
71757886|NCT01746901|143018548|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0136|TWO_SIDED|95.0|3.3|28.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.3|3.3|0.0136
71789755|NCT01031069|143077571|SUPERIORITY|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|3.05|||<|0.0001|TWO_SIDED|97.5|1.84|5.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.||5.06|1.84|<0.0001
71789756|NCT01103284|143077586|SUPERIORITY_OR_OTHER|||||||0.33||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The Mixed-Effect Model Repeated Measure (MMRM) was adjusted for the following baseline covariates: age, C-peptide, insulin dose by body weight and AUC||||||0.33
71671802|NCT01611883|142861656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo||||0.365
71671803|NCT01611883|142861657|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-21.05|||<|0.001|TWO_SIDED|95.0|-25.06|-17.03|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-17.03|-25.06|<0.001
71671804|NCT01611883|142861658|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.54|||<|0.001|TWO_SIDED|95.0|-16.66|-10.42|||Longitudinal analysis of covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-10.42|-16.66|<0.001
71757887|NCT01746901|143018548|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0039|TWO_SIDED|95.0|6.1|31.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||31.0|6.1|0.0039
71757888|NCT01746901|143018548|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1|||<|0.0001|TWO_SIDED|95.0|23.6|48.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||48.5|23.6|<0.0001
71671805|NCT01611883|142861659|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.36||||0.025|TWO_SIDED|95.0|-21.27|-1.44|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-1.44|-21.27|0.025
71757889|NCT01746901|143018548|SUPERIORITY_OR_OTHER||LS Mean Difference|15.4||||0.0157|TWO_SIDED|95.0|2.9|27.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.8|2.9|0.0157
71757890|NCT01746901|143018548|SUPERIORITY_OR_OTHER||LS Mean Difference|32.9|||<|0.0001|TWO_SIDED|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|20.5|<0.0001
71757891|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|12.5|||<|0.0001|TWO_SIDED|95.0|6.4|18.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|6.4|<0.0001
71757892|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5||||0.255|TWO_SIDED|95.0|-2.6|9.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||9.6|-2.6|0.2550
71757893|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|10.4||||0.001|TWO_SIDED|95.0|4.3|16.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||16.4|4.3|0.0010
71671806|NCT01611883|142861660|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|2.45||||0.246|TWO_SIDED|95.0|-1.71|6.61|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||6.61|-1.71|0.246
71671807|NCT01611883|142861661|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-19.07|||<|0.001|TWO_SIDED|95.0|-22.71|-15.43|||Longitudinal Analysis of Covariance|"Treatment group, HbA1c level, insulin use, time, and time × treatment group interaction as factors, and baseline as covariate"|ezetimibe minus placebo|||-15.43|-22.71|<0.001
71757894|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|5.7||||0.0667|TWO_SIDED|95.0|-0.4|11.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.8|-0.4|0.0667
71757895|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|8.3||||0.0075|TWO_SIDED|95.0|2.3|14.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|2.3|0.0075
71757896|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6||||0.1354|TWO_SIDED|95.0|-1.5|10.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.7|-1.5|0.1354
71757897|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|50.9|||<|0.0001|TWO_SIDED|95.0|34.2|67.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||67.5|34.2|<0.0001
71757898|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.3905|TWO_SIDED|95.0|-9.4|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||24.0|-9.4|0.3905
71757899|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|28.6||||0.0009|TWO_SIDED|95.0|11.9|45.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.3|11.9|0.0009
71757900|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|29.6||||0.0006|TWO_SIDED|95.0|12.9|46.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||46.3|12.9|0.0006
71789757|NCT01103284|143077587|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED|||||A priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC.||||||0.68
71789758|NCT01103284|143077588|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC||||||0.44
71789759|NCT01103284|143077590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.07|TWO_SIDED|95.0|-0.02|0.79||Standard multiple imputation was used to predict the number and timing of hypoglycemic events after discontinuing the study for subjects who did not remain in the study until Month 25.|negative binomial regression|||The number of hypoglycemia events during the study was analyzed using a negative binomial regression model, with number of events as the dependent variable, and treatment, age, baseline daily insulin dose, and baseline C-peptide as covariates. The log of duration in the study for each patient was used as an offset variable in the model.||0.79|-0.02|0.07
71671808|NCT01622673|142861662|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.678|||||TWO_SIDED|90.0|0.531|0.866|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for TUMS® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.866|0.531|
71813324|NCT01181726|143129081|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.19|||||TWO_SIDED|90.0|91.18|99.38|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.38|91.18|
71813325|NCT01181726|143129082|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.23|||||TWO_SIDED|90.0|91.17|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||99.47|91.17|
71757901|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|22.9||||0.0072|TWO_SIDED|95.0|6.3|39.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.5|6.3|0.0072
71757902|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0||||0.0035|TWO_SIDED|95.0|8.4|41.6|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||41.6|8.4|0.0035
71757903|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|248.4|||<|0.0001|TWO_SIDED|95.0|188.6|308.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||308.3|188.6|<0.0001
71757904|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|68.2||||0.0263|TWO_SIDED|95.0|8.2|128.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||128.2|8.2|0.0263
71789760|NCT02801942|143077606|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|3.307|||TWO_SIDED|95.0|-4.59|9.21|||||The mean difference in circulating B lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||9.21|-4.59|
71789761|NCT02801942|143077606|OTHER||Mean Difference (Final Values)|3.54|STANDARD_ERROR_OF_MEAN|2.398|||TWO_SIDED|95.0|-1.46|8.54|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||8.54|-1.46|
71838149|NCT05492318|143183563|OTHER|GMR corresponds to the ratio of the Geometric LSmeans of Dabigatran Etexilate Co-Administered with Givinostat (Day 17) and the Geometric Lsmeans of Dabigatran Etexilate Alone (Day 1)|ratio of the Geometric LSmeans|73.45|||||TWO_SIDED|90.0|60.79|88.75||||||Free Dabigatran: Potential Induction Effect of Givinostat on the Pharmacokinetics of Dabigatran Etexilate. AUC0-inf||88.75|60.79|
71838150|NCT03365882|143183641|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.44|TWO_SIDED|95.0|0.43|1.45|||Log Rank|||||1.45|0.43|0.44
71838151|NCT03365882|143183643|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
71789762|NCT02801942|143077606|OTHER||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.854|||TWO_SIDED|95.0|-6.87|0.86|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||0.86|-6.87|
71789763|NCT02801942|143077606|OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|4.482||||95.0|-11.86|6.84|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.|||6.84|-11.86|
71789764|NCT02801942|143077607|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|2.658|||TWO_SIDED|95.0|-2.22|8.98|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.98|-2.22|
71789765|NCT02801942|143077607|OTHER||Mean Difference (Final Values)|8.59|STANDARD_ERROR_OF_MEAN|5.833|||TWO_SIDED|95.0|-3.72|20.91|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||20.91|-3.72|
71838152|NCT04323137|143183645|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||"This analysis compared all groups that were informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm) to control patients who were not sent a message.~Null hypothesis: informing patients they are high risk for flu and flu-related complications does not increase flu vaccination rate; Alternative hypothesis: informing patients they are high risk for flu and flu-related complications increases flu vaccination rate"||||0.0035
71838153|NCT04323137|143183645|SUPERIORITY|||||||0.613||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on medical records messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on medical records. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.613
71838154|NCT04323137|143183645|SUPERIORITY|||||||0.889||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk only and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk only and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||0.889
71838155|NCT04323137|143183645|SUPERIORITY|||||||0.714||||||The p-value reported is uncorrected, but the Holm method was used to determine whether the p-value reached statistical significance.|Regression, Logistic|||Null hypothesis: the High risk based on medical records and High risk based on algorithm messages are equally effective at promoting ﬂu vaccinations; Alternative hypothesis: there is a difference in effectiveness between High risk based on medical records and High risk based on algorithm messages. Separate regressions were run to assess pairwise differences between the high-risk arms (analyses 2, 3, and 4). The Holm method was used to test whether each comparison reached significance.||||.714
71838156|NCT04323137|143183646|SUPERIORITY|||||||0.181||||||This p-value is from the same regression as the top 10% risk vs. top 3% risk contrast (analysis 2).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same risk level who were sent messages with a vague verbal (high risk) vs. specific numeric (top 10%) risk framing.~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.181
71789766|NCT02801942|143077607|OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-6.53|3.38|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.38|-6.53|
71789767|NCT02801942|143077607|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|5.221|||TWO_SIDED|95.0|-19.32|2.71|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.71|-19.32|
71789768|NCT02801942|143077608|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.9|2.75|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.75|-0.90|
71789769|NCT02801942|143077608|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.07|0.19|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.19|-0.07|
71789770|NCT02801942|143077608|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-3.41|2.84|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.84|-3.41|
71789771|NCT02801942|143077608|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.1|0.13|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||0.13|-0.10|
71789772|NCT02801942|143077608|OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.19|0.31|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.31|-0.19|
71671809|NCT01622673|142861662|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.373|||||TWO_SIDED|90.0|0.293|0.475|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean C12hrs for MINTOX® + raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.475|0.293|
71671810|NCT01622673|142861663|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.437|||||TWO_SIDED|90.0|0.344|0.554|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® before raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.554|0.344|
71671811|NCT01622673|142861663|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.433|||||TWO_SIDED|90.0|0.341|0.55|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® after raltegravir / geometric least squares mean C12hrs for raltegravir alone|||0.550|0.341|
71671812|NCT01622673|142861664|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.445|||||TWO_SIDED|90.0|0.35|0.565|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for TUMS® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.565|0.350|
71677215|NCT04143594|142873011|SUPERIORITY||Difference in LSM|44.0||||0.2603|TWO_SIDED|95.0|-33.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-33|0.2603
71757905|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|151.2|||<|0.0001|TWO_SIDED|95.0|91.3|211.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||211.1|91.3|<0.0001
71757906|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|165.4|||<|0.0001|TWO_SIDED|95.0|105.6|225.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||225.3|105.6|<0.0001
71757907|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|97.9||||0.0015|TWO_SIDED|95.0|38.3|157.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||157.6|38.3|0.0015
71757908|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|138.4|||<|0.0001|TWO_SIDED|95.0|78.7|198.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||198.2|78.7|<0.0001
71757909|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|241.3|||<|0.0001|TWO_SIDED|95.0|162.8|319.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||319.9|162.8|<0.0001
71757910|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|121.1||||0.0028|TWO_SIDED|95.0|42.4|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.9|42.4|0.0028
71757911|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|164.4|||<|0.0001|TWO_SIDED|95.0|85.8|243.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.1|85.8|<0.0001
71757912|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|198.0|||<|0.0001|TWO_SIDED|95.0|119.4|276.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||276.6|119.4|<0.0001
71757913|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|111.1||||0.0057|TWO_SIDED|95.0|32.8|189.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||189.4|32.8|0.0057
71757914|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|168.1|||<|0.0001|TWO_SIDED|95.0|89.7|246.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.6|89.7|<0.0001
71757915|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|128.4||||0.036|TWO_SIDED|95.0|8.5|248.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||248.3|8.5|0.0360
71757916|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|221.5||||0.0004|TWO_SIDED|95.0|101.2|341.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||341.7|101.2|0.0004
71757917|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0388|TWO_SIDED|95.0|6.6|246.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||246.8|6.6|0.0388
71757918|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|223.2||||0.0003|TWO_SIDED|95.0|103.2|343.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.2|103.2|0.0003
71671813|NCT01622673|142861664|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.51|||||TWO_SIDED|90.0|0.402|0.646|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.646|0.402|
71671814|NCT01622673|142861665|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.351|0.669|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® before raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.669|0.351|
71671815|NCT01622673|142861665|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.696|||||TWO_SIDED|90.0|0.504|0.96|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® after raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone|||0.960|0.504|
71789773|NCT02801942|143077608|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.482|||TWO_SIDED|95.0|-3.23|2.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.96|-3.23|
71789774|NCT02801942|143077609|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.231|||TWO_SIDED|95.0|-3.14|6.23|||||The mean difference in B-cells in (Healthy participants versus NOT1D participants) iLN has been presented.|||6.23|-3.14|
71789775|NCT02801942|143077609|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.25|0.34|||||The mean difference in CD56bright sNK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.25|
71789776|NCT02801942|143077609|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.253|||TWO_SIDED|95.0|-0.54|0.52|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.52|-0.54|
71789777|NCT02801942|143077609|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.15|0.1|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.10|-0.15|
71789778|NCT02801942|143077609|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|-0.21|0.34|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.21|
71838157|NCT04323137|143183646|SUPERIORITY|||||||0.301||||||This p-value is from the same regression as the high risk vs. top 10% risk contrast (analysis 1).|Regression, Logistic|||"This analysis tested whether vaccination differed in patients with the same numeric risk phrasing are differentially affected due to different specific risk levels (3% vs. 10%).~This analysis was limited to those informed they were high risk (High risk only, High risk based on medical records, High risk based on algorithm)."||||.301
71838158|NCT04229992|143183663|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo."||||<0.05
71838159|NCT04229992|143183664|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear mode adjusted for age, sex, BMI and baseline level||"1. GG genotype and magnesium treatment vs GG genotype and placebo;~2. GA/AA genotype and magnesium treatment vs GA/AA genotype and Placebo"||||<0.05
71838160|NCT03770273|143183665|OTHER|||||||0.774|||||||Regression, Linear|||||||0.7740
71838161|NCT03770273|143183667|OTHER|||||||0.1071|||||||Regression, Linear|||||||0.1071
71838162|NCT03770273|143183668|OTHER|||||||0.4904|||||||Regression, Linear|||||||0.4904
71677216|NCT04143594|142873012|SUPERIORITY||Difference in LSM|-31.0||||0.4827|TWO_SIDED|95.0|-119.0|57.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||57|-119|0.4827
71789779|NCT02801942|143077609|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.487|||TWO_SIDED|95.0|-1.1|0.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-1.10|
71789780|NCT02801942|143077610|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.326|||TWO_SIDED|95.0|-1.73|3.8|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.80|-1.73|
71838163|NCT03770273|143183669|OTHER|||||||0.1399|||||||Regression, Linear|||||||0.1399
71838164|NCT05177848|143183687|OTHER|||||||0.9793||||||"A linear mixed effects model tested the interaction between group and condition on the rate of substitution~Results:~Condition: X2(6) = 4.30, p = 0.64 Group: X2(1) 0.22, p = 0.64 Condition:Group: X2(6) = 1.15, p = 0.98"|Mixed Models Analysis|||||||0.9793
71838165|NCT05177848|143183688|OTHER|||||||0.29||||||"A linear mixed effects model tested the interaction between group and condition on Q0 (derived intensity).~Results:~Condition: X2(6) = 6.59, p = 0.36 Group: X2(1) = 0.07, p = 0.79 Condition:Group: X2(6) = 7.38, p = 0.29"|Mixed Models Analysis|||||||0.29
71838166|NCT05177848|143183688|OTHER|||||||0.46||||||"A linear mixed effects model tested the interaction between group and condition on Alpha (demand elasticity).~Results:~Condition: X2(6) = 0.0001, p = 1.00 Group: X2(1) = 0.00, p = 0.99 Condition:Group: X2(6) = 5.65, p = 0.46"|Mixed Models Analysis|||||||0.46
71838167|NCT01084876|143183689|EQUIVALENCE|The therapeutic equivalence between CT-P6 and Herceptin is concluded if the 95% confidence interval (CI) for the risk difference (CT-P6 - Herceptin) estimate in ORR ITRC review during the Main Study Treatment Period is entirely within the predefined equivalence margin of -0.15 to 0.15.|Risk Difference (RD)|-0.0535|||||TWO_SIDED|95.0|-0.143|0.036||||||||0.036|-0.143|
71789781|NCT02801942|143077610|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|2.324|||TWO_SIDED|95.0|-7.54|2.16|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.|||2.16|-7.54|
71671816|NCT01622673|142861666|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.476|||||TWO_SIDED|90.0|0.362|0.627|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for TUMS® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.627|0.362|
71671817|NCT01622673|142861666|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.555|||||TWO_SIDED|95.0|0.423|0.729|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and treatment period and random effect for participant|The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean Cmax for MINTOX® + raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.729|0.423|
71671818|NCT01622673|142861667|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||TWO_SIDED|90.0|0.332|0.709|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® before raltegravir / geometric least squares mean Cmax for raltegravir alone|||0.709|0.332|
71671819|NCT01622673|142861667|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.775|||||TWO_SIDED|90.0|0.53|1.132|||Mixed Models Analysis|Analysis incorporated fixed effect for treatment and random effect for participant|The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® after raltegravir / geometric least squares mean Cmax for raltegravir alone|||1.132|0.530|
71671820|NCT05142722|142861694|SUPERIORITY||Least Squares (LS) Means|-32.65|STANDARD_ERROR_OF_MEAN|1.602|<|0.0001|TWO_SIDED|95.0|-35.79|-29.5|||ANCOVA|||||-29.50|-35.79|<.0001
71671821|NCT05142722|142861695|SUPERIORITY||Least Squares (LS) Means|-33.78|STANDARD_ERROR_OF_MEAN|1.678|<|0.0001|TWO_SIDED|95.0|-37.07|-30.49|||ANCOVA|||||-30.49|-37.07|<.0001
71671822|NCT05142722|142861696|SUPERIORITY||Least Squares (LS) Means|-23.98|STANDARD_ERROR_OF_MEAN|1.979|<|0.0001|TWO_SIDED|95.0|-27.87|-20.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-20.09|-27.87|<.0001
71671823|NCT05142722|142861697|SUPERIORITY||Least Squares (LS) Means|-18.92|STANDARD_ERROR_OF_MEAN|0.936|<|0.0001|TWO_SIDED|95.0|-20.76|-17.09||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-17.09|-20.76|<.0001
71671824|NCT05142722|142861698|SUPERIORITY||Least Squares (LS) Means|-18.31|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-20.38|-16.23||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-16.23|-20.38|<.0001
71671825|NCT05142722|142861699|SUPERIORITY||Least Squares (LS) Means|-13.8|STANDARD_ERROR_OF_MEAN|1.219|<|0.0001|TWO_SIDED|95.0|-16.2|-11.41||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-11.41|-16.20|<.0001
71671826|NCT05142722|142861700|SUPERIORITY||Least Squares (LS) Means|-29.44|STANDARD_ERROR_OF_MEAN|1.251|<|0.0001|TWO_SIDED|95.0|-31.89|-26.99||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-26.99|-31.89|<.0001
71671827|NCT05142722|142861701|SUPERIORITY||Least Squares (LS) Means|-28.32|STANDARD_ERROR_OF_MEAN|1.339|<|0.0001|TWO_SIDED|95.0|-30.94|-25.69||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-25.69|-30.94|<.0001
71671828|NCT05142722|142861702|SUPERIORITY||Least Squares (LS) Means|-23.02|STANDARD_ERROR_OF_MEAN|1.564|<|0.0001|TWO_SIDED|95.0|-26.09|-19.95||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||-19.95|-26.09|<.0001
71757919|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|107.2||||0.0787|TWO_SIDED|95.0|-12.4|226.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||226.8|-12.4|0.0787
71757920|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|181.3||||0.0033|TWO_SIDED|95.0|61.5|301.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||301.0|61.5|0.0033
71757921|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1||||0.1688|TWO_SIDED|95.0|-41.2|233.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||233.3|-41.2|0.1688
71789782|NCT02801942|143077610|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.12|1.95|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.|||1.95|-1.12|
71757922|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|220.3||||0.0019|TWO_SIDED|95.0|82.6|358.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||358.0|82.6|0.0019
71757923|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|106.0||||0.1298|TWO_SIDED|95.0|-31.5|243.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||243.5|-31.5|0.1298
71757924|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|210.4||||0.0029|TWO_SIDED|95.0|73.0|347.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.8|73.0|0.0029
71671829|NCT05142722|142861703|SUPERIORITY||Least Squares (LS) Means|136.26|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|132.46|140.07||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||140.07|132.46|<.0001
71671830|NCT05142722|142861704|SUPERIORITY||Least Squares (LS) Means|134.43|STANDARD_ERROR_OF_MEAN|2.343|<|0.0001|TWO_SIDED|95.0|129.84|139.03||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||139.03|129.84|<.0001
71789783|NCT02801942|143077611|OTHER||Mean Difference (Final Values)|6.84|STANDARD_ERROR_OF_MEAN|5.564|||TWO_SIDED|95.0|-4.92|18.6|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||18.60|-4.92|
71789784|NCT02801942|143077611|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|7.918|||TWO_SIDED|95.0|-24.77|9.0|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.00|-24.77|
71789785|NCT02801942|143077611|OTHER||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-6.66|3.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.73|-6.66|
71789786|NCT02801942|143077612|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|4.558|||TWO_SIDED|95.0|-8.17|10.84|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.84|-8.17|
71789787|NCT02801942|143077612|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|4.658|||TWO_SIDED|95.0|-11.57|7.86|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.86|-11.57|
71789788|NCT02801942|143077613|OTHER||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|5.658|||TWO_SIDED|95.0|0.38|24.09|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||24.09|0.38|
71789789|NCT02801942|143077613|OTHER||Mean Difference (Final Values)|-10.87|STANDARD_ERROR_OF_MEAN|6.961|||TWO_SIDED|95.0|-25.52|3.78|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.78|-25.52|
71789790|NCT02801942|143077616|OTHER||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|6.329|||TWO_SIDED|95.0|-11.41|14.99|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||14.99|-11.41|
71789791|NCT02801942|143077616|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-4.6|4.91|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||4.91|-4.60|
71671831|NCT05142722|142861705|SUPERIORITY||Least Squares (LS) Means|122.04|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|95.0|117.53|126.55||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05|ANCOVA|||||126.55|117.53|<.0001
71671832|NCT05142722|142861706|SUPERIORITY||Least Squares (LS) Means|-14.12|STANDARD_ERROR_OF_MEAN|20.183||0.4841|TWO_SIDED|95.0|-53.68|25.44||The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints|ANCOVA|||||25.44|-53.68|0.4841
71789792|NCT02801942|143077616|OTHER||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|3.297|||TWO_SIDED|95.0|-2.5|11.26|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||11.26|-2.50|
71789793|NCT02801942|143077616|OTHER||Mean Difference (Final Values)|-6.06|STANDARD_ERROR_OF_MEAN|5.729|||TWO_SIDED|95.0|-18.01|5.89|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||5.89|-18.01|
71789794|NCT02801942|143077616|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-0.67|0.6|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in blood has been presented.|||0.60|-0.67|
71789795|NCT02801942|143077617|OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|3.133|||TWO_SIDED|95.0|-5.33|7.73|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.73|-5.33|
71789796|NCT02801942|143077617|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.466|||TWO_SIDED|95.0|-3.73|2.41|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.41|-3.73|
71789797|NCT02801942|143077617|OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-7.67|3.96|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.96|-7.67|
71789798|NCT02801942|143077617|OTHER||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|6.342|||TWO_SIDED|95.0|-12.54|13.87|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||13.87|-12.54|
71789799|NCT02801942|143077617|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-1.71|0.36|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.36|-1.71|
71838168|NCT05746494|143183704|OTHER|Omnibus analysis||||||0.023|||||||ANOVA|||||||0.023
71838169|NCT05746494|143183705|OTHER|Omnibus analysis||||||0.042|||||||Multilevel Modeling|||||||0.042
71671833|NCT01467713|142861752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.286|TWO_SIDED|98.3|0.42|1.39|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.39|0.42|0.286
71671834|NCT01467713|142861752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.332|TWO_SIDED|98.3|0.43|1.43|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.43|0.43|0.332
71671835|NCT01467713|142861752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.808|TWO_SIDED|98.3|0.6|1.86|||Log Rank||Cox proportional hazards model with only treatment in the model.|||1.86|0.60|0.808
71671836|NCT01467713|142861752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.286|TWO_SIDED|98.3|0.48|1.61|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.61|0.48|0.286
71671837|NCT01467713|142861752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.332|TWO_SIDED|98.3|0.42|1.49|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.49|0.42|0.332
71757925|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|108.7||||0.1189|TWO_SIDED|95.0|-28.3|245.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||245.7|-28.3|0.1189
71757926|NCT01746901|143018549|SUPERIORITY_OR_OTHER||LS Mean Difference|153.6||||0.0284|TWO_SIDED|95.0|16.4|290.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||290.8|16.4|0.0284
71757927|NCT01746901|143018550|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0327|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.1|-3.4|0.0327
71757928|NCT01746901|143018550|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0019|TWO_SIDED|95.0|1.0|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.2|1.0|0.0019
71757929|NCT01746901|143018550|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.7508|TWO_SIDED|95.0|-1.9|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.9|0.7508
71757930|NCT01746901|143018550|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.1868|TWO_SIDED|95.0|-0.5|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.7|-0.5|0.1868
71757931|NCT01746901|143018550|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-1.6|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.6|-1.6|0.9944
71757932|NCT01746901|143018550|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.2322|TWO_SIDED|95.0|-0.6|2.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.6|-0.6|0.2322
71757933|NCT01746901|143018551|SUPERIORITY_OR_OTHER||LS Mean Difference|28.2|||<|0.0001|TWO_SIDED|95.0|16.8|39.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||39.6|16.8|<0.0001
71757934|NCT01746901|143018551|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.1421|TWO_SIDED|95.0|-2.8|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||19.6|-2.8|0.1421
71757935|NCT01746901|143018551|SUPERIORITY_OR_OTHER||LS Mean Difference|20.9||||0.0004|TWO_SIDED|95.0|9.5|32.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||32.2|9.5|0.0004
71789800|NCT02801942|143077620|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|95.0|-0.84|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.16|-0.84|
71789801|NCT02801942|143077621|OTHER||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-15.37|2.96|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.96|-15.37|
71789802|NCT02801942|143077622|OTHER||Mean Difference (Final Values)|1.03|STANDARD_ERROR_OF_MEAN|1.269|||TWO_SIDED|95.0|-1.61|3.68|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.68|-1.61|
71789803|NCT02801942|143077622|OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|3.152|||TWO_SIDED|95.0|-8.12|5.03|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.03|-8.12|
71757936|NCT01746901|143018551|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.0064|TWO_SIDED|95.0|4.5|27.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||27.0|4.5|0.0064
71757937|NCT01746901|143018551|SUPERIORITY_OR_OTHER||LS Mean Difference|7.4||||0.1974|TWO_SIDED|95.0|-3.9|18.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.6|-3.9|0.1974
71757938|NCT01746901|143018551|SUPERIORITY_OR_OTHER||LS Mean Difference|19.5||||0.0008|TWO_SIDED|95.0|8.3|30.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.8|8.3|0.0008
71757939|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|12.2|||<|0.0001|TWO_SIDED|95.0|7.1|17.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||17.4|7.1|<0.0001
71757940|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.6868|TWO_SIDED|95.0|-4.1|6.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||6.2|-4.1|0.6868
71789804|NCT02801942|143077622|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.089|||TWO_SIDED|95.0|-4.59|4.13|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.13|-4.59|
71789805|NCT02801942|143077622|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|3.835|||TWO_SIDED|95.0|-7.08|8.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.92|-7.08|
71789806|NCT02801942|143077622|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|-0.4|0.21|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.21|-0.40|
71789807|NCT02801942|143077623|OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.236||||95.0|-0.23|0.75|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.75|-0.23|
71838170|NCT05746494|143183706|OTHER|Omnibus analysis||||||0.98|||||||t-test, 2 sided|||||||0.980
71838171|NCT05746494|143183707|OTHER|Omnibus analysis||||||0.01|||||||Multilevel Modeling|||||||0.010
71671838|NCT01467713|142861752|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.808|TWO_SIDED|98.3|0.6|1.95|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.|||1.95|0.60|0.808
71838172|NCT05746494|143183708|OTHER|Omnibus analysis||||||0.064|||||||t-test, 2 sided|||||||0.064
71838173|NCT05746494|143183709|OTHER|Omnibus analysis||||||0.306|||||||t-test, 2 sided|||||||0.306
71838174|NCT05746494|143183710|OTHER|Omnibus analysis||||||0.041|||||||t-test, 2 sided|||||||0.041
71838175|NCT05746494|143183711|OTHER|Omnibus analysis||||||0.019|||||||t-test, 2 sided|||||||0.019
71838176|NCT05409183|143183712|OTHER||LS Mean of Treatment Difference|26.473|STANDARD_ERROR_OF_MEAN|9.216||0.0032|TWO_SIDED|95.0|7.847|45.099|||ANCOVA|||||45.099|7.847|0.0032
71838177|NCT04489771|143183724|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC risk categories (favorable vs. intermediate or poor).|Difference in Percentage|-0.5||||0.5312|TWO_SIDED|95.0|-14.0|12.9||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan 200 mg minus Belzutifan 120 mg|||12.9|-14.0|0.5312
71892487|NCT01381094|143306465|SUPERIORITY||||||=|0.1626|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.1626
71671839|NCT04846569|142861764|SUPERIORITY||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.38|0.39||||||||0.39|-0.38|
71671840|NCT04846569|142861765|SUPERIORITY||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.78|0.47||||||||0.47|-0.78|
71757941|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0058|TWO_SIDED|95.0|2.2|12.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.5|2.2|0.0058
71757942|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9||||0.0229|TWO_SIDED|95.0|0.8|11.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.1|0.8|0.0229
71757943|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2||||0.2168|TWO_SIDED|95.0|-1.9|8.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||8.3|-1.9|0.2168
71757944|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8||||0.0096|TWO_SIDED|95.0|1.7|11.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.9|1.7|0.0096
71757945|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|33.0|||<|0.0001|TWO_SIDED|95.0|20.0|45.9|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||45.9|20.0|<0.0001
71757946|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6||||0.8009|TWO_SIDED|95.0|-11.2|14.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||14.4|-11.2|0.8009
71757947|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|17.4||||0.0086|TWO_SIDED|95.0|4.5|30.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.3|4.5|0.0086
71757948|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|17.2||||0.0089|TWO_SIDED|95.0|4.4|30.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||30.0|4.4|0.0089
71757949|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.4224|TWO_SIDED|95.0|-7.6|18.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||18.0|-7.6|0.4224
71757950|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|22.6||||0.0006|TWO_SIDED|95.0|9.8|35.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||35.5|9.8|0.0006
71757951|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|96.1|||<|0.0001|TWO_SIDED|95.0|57.9|134.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||134.2|57.9|<0.0001
71757952|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|21.9||||0.253|TWO_SIDED|95.0|-15.8|59.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||59.7|-15.8|0.2530
71757953|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|78.6|||<|0.0001|TWO_SIDED|95.0|40.5|116.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||116.8|40.5|<0.0001
71757954|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|39.3||||0.0414|TWO_SIDED|95.0|1.6|77.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||77.1|1.6|0.0414
71757955|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|28.9||||0.1329|TWO_SIDED|95.0|-8.9|66.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||66.6|-8.9|0.1329
71757956|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|45.5||||0.0187|TWO_SIDED|95.0|7.7|83.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|7.7|0.0187
71757957|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|76.9||||0.0009|TWO_SIDED|95.0|31.9|121.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||121.9|31.9|0.0009
71789808|NCT02801942|143077623|OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|3.943|||TWO_SIDED|95.0|-10.2|6.29|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.29|-10.20|
71789809|NCT02801942|143077623|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.621|||TWO_SIDED|95.0|-5.38|9.69|||||The mean difference in Effector Memory Conv T cells(Healthy participants versus NOT1D participants) in iLN has been presented.|||9.69|-5.38|
71789810|NCT02801942|143077623|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|4.629|||TWO_SIDED|95.0|-10.47|8.86|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.86|-10.47|
71789811|NCT02801942|143077623|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|-0.77|0.34|||||The mean difference in Stem cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.34|-0.77|
71789812|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|2.556|||TWO_SIDED|95.0|-10.42|0.25|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.25|-10.42|
71789813|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.15|0.07|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.07|-0.15|
71789814|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.08|2.88|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.88|-3.08|
71789815|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|4.294|||TWO_SIDED|95.0|-6.87|11.05|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||11.05|-6.87|
71789816|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-4.94|5.0|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||5.00|-4.94|
71892488|NCT01381094|143306465|SUPERIORITY||||||=|0.0366|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0366
71671841|NCT04846569|142861766|SUPERIORITY|||||||||||||||||All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated.|All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated as originally planned.|||
71671842|NCT04846569|142861767|SUPERIORITY||Median Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.2|0.53||||||||0.53|-0.20|
71671843|NCT04846569|142861768|OTHER|Qualitative data analysis|||||||||||||||||Thematic qualitative data analysis was conducted to determine the count of participants reporting positively about the intervention|||
71789817|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.112|||TWO_SIDED|95.0|-2.31|2.32|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.32|-2.31|
71789818|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|95.0|-2.73|1.55|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.55|-2.73|
71789819|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|1.474|||TWO_SIDED|95.0|-1.51|4.64|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||4.64|-1.51|
71789820|NCT02801942|143077624|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.504|||TWO_SIDED|95.0|-1.05|1.05|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-1.05|
71789821|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|3.607|||TWO_SIDED|95.0|-5.99|9.07|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||9.07|-5.99|
71789822|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.855|||TWO_SIDED|95.0|-2.43|1.18|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.18|-2.43|
71789823|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|1.391|||TWO_SIDED|95.0|-2.49|3.31|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.31|-2.49|
71789824|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.824|||TWO_SIDED|95.0|-9.39|2.39|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.39|-9.39|
71789825|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.738|||TWO_SIDED|95.0|-1.29|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.78|-1.29|
71789826|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.544|||TWO_SIDED|95.0|-0.73|1.54|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.54|-0.73|
71789827|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.246|||TWO_SIDED|95.0|-2.12|3.07|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.07|-2.12|
71789828|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|2.641|||TWO_SIDED|95.0|-2.45|8.55|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||8.55|-2.45|
71789829|NCT02801942|143077625|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|95.0|-0.92|0.96|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||0.96|-0.92|
71789830|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|-4.83|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.71|1.05|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.05|-10.71|
71789831|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.953|||TWO_SIDED|95.0|-2.82|1.16|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.16|-2.82|
71671844|NCT01100086|142861782|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|102.0|||||TWO_SIDED|90.0|99.35|105.42|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||105.42|99.35|
71789832|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|-2.88|STANDARD_ERROR_OF_MEAN|1.536||||95.0|-6.08|0.33|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.33|-6.08|
71789833|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|0.963|||TWO_SIDED|95.0|-0.2|3.81|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.81|-0.20|
71789834|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.289|||TWO_SIDED|95.0|-2.99|2.39|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.39|-2.99|
71789835|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.907|||TWO_SIDED|95.0|-0.59|7.36|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.36|-0.59|
71789836|NCT02801942|143077626|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.413|||TWO_SIDED|95.0|-4.11|1.78|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.78|-4.11|
71789837|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|2.918|||TWO_SIDED|95.0|-5.6|6.63|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-5.60|
71789838|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.842|||TWO_SIDED|95.0|-7.93|-0.26|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||-0.26|-7.93|
71789839|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|1.209|||TWO_SIDED|95.0|-4.34|1.24|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.24|-4.34|
71789840|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.725|||TWO_SIDED|95.0|-4.51|2.77|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.77|-4.51|
71789841|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.193|||TWO_SIDED|95.0|-5.02|4.09|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.09|-5.02|
71789842|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|3.405|||TWO_SIDED|95.0|-6.52|7.68|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.68|-6.52|
71789843|NCT02801942|143077627|OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.811|||TWO_SIDED|95.0|-2.21|1.4|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.40|-2.21|
71838178|NCT04489771|143183725|OTHER||Hazard Ratio (HR)|0.94||||0.3861|TWO_SIDED|95.0|0.63|1.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.40|0.63|0.3861
71671845|NCT01100086|142861783|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.0|||||TWO_SIDED|90.0|94.94|101.19|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.19|94.94|
71838179|NCT04489771|143183727|OTHER|One-sided nominal p-value, difference in percentage and associated 95% CIs were based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate or poor).|Miettinen & Nurminen method|-6.3||||0.7832|TWO_SIDED|95.0|-21.7|9.4|||Miettinen & Nurminen method|||||9.4|-21.7|0.7832
71671846|NCT01100086|142861784|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
71789844|NCT02801942|143077628|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.86|1.65|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.65|-0.86|
71789845|NCT02801942|143077629|OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.929|||TWO_SIDED|95.0|-2.18|1.7|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||1.70|-2.18|
71789846|NCT02801942|143077630|OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|95.0|0.02|1.87|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.87|0.02|
71789847|NCT02801942|143077630|OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.04|0.38|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.38|-2.04|
71789848|NCT02801942|143077631|OTHER||Mean Difference (Final Values)|-2.77|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.81|6.27|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.27|-11.81|
71789849|NCT02801942|143077631|OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-0.04|4.44|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.44|-0.04|
71789850|NCT02801942|143077632|OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|2.214|||TWO_SIDED|95.0|-5.91|3.32|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.32|-5.91|
71789851|NCT02801942|143077632|OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.28|1.57|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.28|
71838180|NCT04489771|143183728|OTHER||Hazard Ratio (HR)|1.11||||0.6448|TWO_SIDED|95.0|0.65|1.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Log Rank|One-sided nominal p-value based on log-rank test stratified by IMDC risk group (favorable vs. intermediate or poor).|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate or poor).|||1.90|0.65|0.6448
71838181|NCT03241459|143183735|NON_INFERIORITY|15.0% is the absolute noninferiority margin (50% of the difference in primary patency rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|-3.7||||0.0029|ONE_SIDED|97.5|-11.7|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary effectiveness endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to efficacy endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-11.7|0.0029
71838182|NCT03241459|143183736|NON_INFERIORITY|10.0% is the absolute noninferiority margin (50% of the difference in primary safety endpoint rate between IN.PACT Admiral DCB and PTA).|Difference in percentage|2.0|||<|0.0001|ONE_SIDED|97.5|-4.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 10% and a one-sided significance level of 0.025.|Farrington-Manning test||For subjects missing primary safety endpoint status, a logistic regression model was used for multiple imputation with pre-specified baseline variables as model predictors.|The SurVeil DCB will be declared noninferior to IN.PACT Admiral DCB with respect to safety endpoint if the null hypothesis of inferiority is rejected at a one-sided significance level of 0.025.|||-4.1|<.0001
71838183|NCT03241459|143183737|SUPERIORITY|||||||0.579|TWO_SIDED|95.0||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a p-value from a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||0.579
71838184|NCT03241459|143183738|SUPERIORITY|||||||1||||||Both arms demonstrated 100% success, therefore, Fisher's exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.00
71838185|NCT03241459|143183739|SUPERIORITY|||||||1||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||The incidence estimates will be reported along with a two-sided Fisher's exact test comparing the SurVeil and the IN.PACT Admiral groups.||||1.000
71892489|NCT01381094|143306465|SUPERIORITY||||||=|0.0004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0004
71789852|NCT02801942|143077632|OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|3.017|||TWO_SIDED|95.0|-2.08|10.51|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||10.51|-2.08|
71789853|NCT02801942|143077632|OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-3.03|1.08|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.08|-3.03|
71789854|NCT02801942|143077632|OTHER||Mean Difference (Final Values)|-4.86|STANDARD_ERROR_OF_MEAN|3.802|||TWO_SIDED|95.0|-12.8|3.07|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.07|-12.80|
71789855|NCT02801942|143077632|OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.733|||TWO_SIDED|95.0|-1.27|18.47|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||18.47|-1.27|
71789856|NCT02801942|143077633|OTHER||Mean Difference (Final Values)|6.53|STANDARD_ERROR_OF_MEAN|4.905||||95.0|-3.78|16.85|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||16.85|-3.78|
71789857|NCT02801942|143077633|OTHER||Mean Difference (Final Values)|-8.54|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-18.17|1.1|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.10|-18.17|
71789858|NCT02801942|143077633|OTHER||Mean Difference (Final Values)|2.11|STANDARD_ERROR_OF_MEAN|2.519|||TWO_SIDED|95.0|-3.23|7.45|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.45|-3.23|
71892490|NCT01381094|143306465|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0012
71892491|NCT01381094|143306465|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71892492|NCT01381094|143306465|SUPERIORITY||||||=|0.1779|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.1779
71789859|NCT02801942|143077633|OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-0.98|7.59|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.|||7.59|-0.98|
71838186|NCT03241459|143183740|SUPERIORITY|||||||0.494||||||P-value is derived from two-sided Fisher's exact test.|Fisher Exact|||||||0.494
71838187|NCT03241459|143183741|NON_INFERIORITY|The Farrington and Manning test for noninferiority of proportions at a one-sided significance level of 0.025.|Difference in percentage|-1.9||||0.0059|ONE_SIDED|97.5|-12.1|||P-value is derived from one-sided Farrington-Manning test with noninferiority margin of 15% and a one-sided significance level of 0.025.|Farrington-Manning test|||The objective is to assess whether the primary patency rate of subjects in the SurVeil DCB group is noninferior to that of the IN.PACT Admiral DCB group:|||-12.1|0.0059
71671847|NCT01100086|142861784|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|98.3|||||TWO_SIDED|90.0|95.2|101.48|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.48|95.20|
71671848|NCT02954601|142861785|OTHER|Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment, Period and Baseline value (for change and percent change) are factors in the model with repeated values for a subject.||||||0.1311|||||||Mixed Models Analysis|||||||0.1311
71789860|NCT02801942|143077633|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.026|||TWO_SIDED|95.0|-8.23|8.67|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||8.67|-8.23|
71671849|NCT02954601|142861788|OTHER|||||||0.3061|TWO_SIDED|95.0|||||Mixed Models Analysis|||Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment period and Baseline value (for change and percent change) are factors in the model with repeated values for subject.||||0.3061
71757958|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|45.4||||0.0456|TWO_SIDED|95.0|0.9|89.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||89.9|0.9|0.0456
71757959|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|82.8||||0.0004|TWO_SIDED|95.0|37.8|127.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||127.7|37.8|0.0004
71757960|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|39.6||||0.0812|TWO_SIDED|95.0|-5.0|84.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||84.1|-5.0|0.0812
71757961|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|35.5||||0.1174|TWO_SIDED|95.0|-9.0|80.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.0|-9.0|0.1174
71757962|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|46.1||||0.0427|TWO_SIDED|95.0|1.5|90.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||90.6|1.5|0.0427
71757963|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0||||0.9318|TWO_SIDED|95.0|-66.9|73.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||73.0|-66.9|0.9318
71757964|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|110.4||||0.002|TWO_SIDED|95.0|41.2|179.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||179.6|41.2|0.0020
71757965|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|81.5||||0.0226|TWO_SIDED|95.0|11.6|151.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||151.4|11.6|0.0226
71757966|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|32.0||||0.3629|TWO_SIDED|95.0|-37.3|101.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||101.2|-37.3|0.3629
71757967|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|35.9||||0.3077|TWO_SIDED|95.0|-33.4|105.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||105.1|-33.4|0.3077
71757968|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|39.1||||0.2662|TWO_SIDED|95.0|-30.1|108.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||108.4|-30.1|0.2662
71757969|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.4||||0.7875|TWO_SIDED|95.0|-94.7|71.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||71.9|-94.7|0.7875
71757970|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|115.0||||0.0066|TWO_SIDED|95.0|32.6|197.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||197.4|32.6|0.0066
71757971|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|81.7||||0.054|TWO_SIDED|95.0|-1.4|164.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.9|-1.4|0.0540
71757972|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8||||0.6014|TWO_SIDED|95.0|-60.6|104.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||104.3|-60.6|0.6014
71757973|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|36.1||||0.3885|TWO_SIDED|95.0|-46.3|118.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||118.5|-46.3|0.3885
71757974|NCT01746901|143018552|SUPERIORITY_OR_OTHER||LS Mean Difference|29.5||||0.4801|TWO_SIDED|95.0|-52.9|112.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||112.0|-52.9|0.4801
71757975|NCT01746901|143018553|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.5494|TWO_SIDED|95.0|-2.5|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-2.5|0.5494
71789861|NCT02801942|143077633|OTHER||Mean Difference (Final Values)|8.31|STANDARD_ERROR_OF_MEAN|4.595|||TWO_SIDED|95.0|-1.32|17.95|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||17.95|-1.32|
71789862|NCT02801942|143077634|OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.601|||TWO_SIDED|95.0|-0.94|1.57|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|-0.94|
71789863|NCT02801942|143077634|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|95.0|0.0|1.28|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.28|0.00|
71838188|NCT03241459|143183742|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 12 months.||||||0.699||||||12-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||0.699
71789864|NCT02801942|143077634|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|95.0|-0.33|1.11|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.11|-0.33|
71789865|NCT02801942|143077634|OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.78|0.47|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.47|-0.78|
71789866|NCT02801942|143077635|OTHER||Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.989|||TWO_SIDED|95.0|-0.3|3.86|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.86|-0.30|
71789867|NCT02801942|143077635|OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|4.716|||TWO_SIDED|95.0|-12.45|7.35|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.35|-12.45|
71789868|NCT02801942|143077635|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.957|||TWO_SIDED|95.0|-1.86|2.14|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||2.14|-1.86|
71789869|NCT02801942|143077635|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.9|4.58|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||4.58|0.90|
71789870|NCT02801942|143077636|OTHER||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|1.344|||TWO_SIDED|95.0|-2.23|3.38|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||3.38|-2.23|
71838189|NCT03241459|143183742|SUPERIORITY|Target Vessel Patency for SurVeil DCB vs. Target Vessel Patency for IN.PACT DCB at 24 months.||||||1||||||24-Month P-Value|Fisher Exact|||The main analysis of the secondary endpoints will be carried out using the ITT analysis set.||||1.0
71789871|NCT02801942|143077636|OTHER||Mean Difference (Final Values)|0.84|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.1|1.57|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||1.57|0.10|
71789872|NCT02801942|143077636|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.594|||TWO_SIDED|95.0|-0.41|2.07|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||2.07|-0.41|
71789873|NCT02801942|143077636|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|95.0|-1.54|0.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.|||0.92|-1.54|
71789874|NCT02801942|143077637|OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|1.728|||TWO_SIDED|95.0|-0.62|6.63|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||6.63|-0.62|
71789875|NCT02801942|143077637|OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-11.33|7.21|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||7.21|-11.33|
71789876|NCT02801942|143077637|OTHER||Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|2.042|||TWO_SIDED|95.0|-14.56|17.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||17.13|-14.56|
71789877|NCT02801942|143077637|OTHER||Mean Difference (Final Values)|2.14|STANDARD_ERROR_OF_MEAN|0.843|||TWO_SIDED|95.0|0.36|3.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.|||3.92|0.36|
71789878|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.097|||TWO_SIDED|95.0|-4.24|8.83|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.83|-4.24|
71789879|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|2.334|||TWO_SIDED|95.0|-0.47|9.39|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.39|-0.47|
71789880|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|11.54|STANDARD_ERROR_OF_MEAN|7.693|||TWO_SIDED|95.0|-5.24|28.32|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||28.32|-5.24|
71789881|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|5.64|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-7.73|19.01|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||19.01|-7.73|
71789882|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|3.336|||TWO_SIDED|95.0|-8.46|5.71|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.71|-8.46|
71838190|NCT03241459|143183743|SUPERIORITY|||||||0.699|TWO_SIDED|95.0||||6-Month P-Value|Fisher Exact|||||||0.699
71838191|NCT03241459|143183743|SUPERIORITY|||||||0.447||||||12-Month P-Value|Fisher Exact|||||||0.447
71838192|NCT03241459|143183743|SUPERIORITY|||||||0.589||||||24-Month P-Value|Fisher Exact|||||||0.589
71838193|NCT03241459|143183744|SUPERIORITY|||||||1||||||P-Value at 6-Months|Fisher Exact|||||||1.0
71838194|NCT03241459|143183744|SUPERIORITY|||||||0.823||||||P-Value at 12-Months|Fisher Exact|||||||0.823
71838195|NCT03241459|143183744|SUPERIORITY|||||||0.454||||||P-Value at 24-Months|Fisher Exact|||||||0.454
71838196|NCT03241459|143183745|SUPERIORITY|||||||0.535||||||P-Value at 6-Months|Fisher Exact|||||||0.535
71838197|NCT03241459|143183745|SUPERIORITY|||||||0.86||||||P-Value at 12-Months|Fisher Exact|||||||0.860
71838198|NCT03241459|143183745|SUPERIORITY|||||||0.39||||||P-Value at 24-Months|Fisher Exact|||||||0.390
71838199|NCT03241459|143183746|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 6 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
71838200|NCT03241459|143183746|SUPERIORITY|||||||1||||||Both arms demonstrated 0 amputations at 12 months. Fisher's Exact test does not provide a p-value, but we populated it with a p-value of 1.00 to indicate no difference between arms.|Fisher Exact|||||||1.00
71757976|NCT01746901|143018553|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0626|TWO_SIDED|95.0|-0.1|3.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.8|-0.1|0.0626
71757977|NCT01746901|143018553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.7216|TWO_SIDED|95.0|-1.6|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.3|-1.6|0.7216
71757978|NCT01746901|143018553|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.3647|TWO_SIDED|95.0|-1.0|2.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.8|-1.0|0.3647
71757979|NCT01746901|143018553|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.4456|TWO_SIDED|95.0|-2.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.7|0.4456
71757980|NCT01746901|143018553|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.05|TWO_SIDED|95.0|0.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.9|0.0|0.0500
71757981|NCT01746901|143018554|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.34|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.34|-0.69|<0.0001
71757982|NCT01746901|143018554|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.86|-1.52|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.52|-1.86|<0.0001
71757983|NCT01746901|143018554|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.63|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.63|-0.97|<0.0001
71757984|NCT01746901|143018554|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.58|-1.23|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.23|-1.58|<0.0001
71757985|NCT01746901|143018554|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.56|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.56|-0.91|<0.0001
71757986|NCT01746901|143018554|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.46|-1.11|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.11|-1.46|<0.0001
71757987|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|||<|0.0001|TWO_SIDED|95.0|-1.75|-1.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.42|-1.75|<0.0001
71757988|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.3309|TWO_SIDED|95.0|-0.24|0.08|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.08|-0.24|0.3309
71757989|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.42|-0.74|<0.0001
71757990|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.92|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.92|-1.25|<0.0001
71757991|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.59|-0.26|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.26|-0.59|<0.0001
71757992|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.88|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.88|-1.21|<0.0001
71757993|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.03|||<|0.0001|TWO_SIDED|95.0|-4.37|-3.69|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-3.69|-4.37|<0.0001
71757994|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.2475|TWO_SIDED|95.0|-0.54|0.14|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.14|-0.54|0.2475
71757995|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|||<|0.0001|TWO_SIDED|95.0|-1.96|-1.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.27|-1.96|<0.0001
71757996|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.62|||<|0.0001|TWO_SIDED|95.0|-2.96|-2.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.27|-2.96|<0.0001
71838201|NCT03241459|143183746|SUPERIORITY|||||||1||||||P-Value at 24-Months|Fisher Exact|||||||1.0
71838202|NCT03241459|143183747|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71838203|NCT03241459|143183747|SUPERIORITY|||||||0.472||||||P-Value at 24-Months|Fisher Exact|||||||0.472
71838204|NCT03241459|143183748|SUPERIORITY|||||||0.193||||||P-Value for change in Rutherford Classification from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.193
71789883|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|1.755|||TWO_SIDED|95.0|-5.54|1.98|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.98|-5.54|
71789884|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-21.58|4.98|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.98|-21.58|
71789885|NCT02801942|143077638|OTHER||Mean Difference (Final Values)|-8.31|STANDARD_ERROR_OF_MEAN|6.019|||TWO_SIDED|95.0|-21.49|4.87|||||The mean difference in Naive B Lymphocytes by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||4.87|-21.49|
71789886|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.538|||TWO_SIDED|95.0|-0.54|10.48|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.48|-0.54|
71789887|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.37|4.61|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.61|-8.37|
71789888|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-0.26|0.54|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.54|-0.26|
71789889|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.147|||TWO_SIDED|95.0|-0.37|0.27|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.27|-0.37|
71789890|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.402|||TWO_SIDED|95.0|-1.27|0.49|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.49|-1.27|
71838205|NCT03241459|143183748|SUPERIORITY|||||||0.14||||||P-Value for change in Rutherford Classification from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.140
71838206|NCT03241459|143183748|SUPERIORITY|||||||0.372||||||P-Value for change in Rutherford Classification from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.372
71838207|NCT03241459|143183748|SUPERIORITY|||||||0.104||||||P-Value for change in Rutherford Classification from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.104
71789891|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.312|||TWO_SIDED|95.0|-0.33|1.07|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.07|-0.33|
71789892|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.16|0.13|||||The mean difference in CD56lo CD16- by (Healthy participants versus NOT1D participants) FNA method has been presented.|||0.13|-0.16|
71789893|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|95.0|-0.17|0.12|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.12|-0.17|
71789894|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.114|||TWO_SIDED|95.0|-0.03|0.47|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.47|-0.03|
71789895|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.59|0.4|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.40|-0.59|
71789896|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.766|||TWO_SIDED|95.0|-1.72|1.6|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.60|-1.72|
71789897|NCT02801942|143077639|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.417|||TWO_SIDED|95.0|-0.99|0.82|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.82|-0.99|
71789898|NCT02801942|143077640|OTHER||Mean Difference (Final Values)|13.72|STANDARD_ERROR_OF_MEAN|7.475|||TWO_SIDED|95.0|-2.72|30.15|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||30.15|-2.72|
71789899|NCT02801942|143077640|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|7.566|||TWO_SIDED|95.0|-16.85|16.78|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.78|-16.85|
71789900|NCT02801942|143077640|OTHER||Mean Difference (Final Values)|-20.03|STANDARD_ERROR_OF_MEAN|8.586|||TWO_SIDED|95.0|-38.98|-1.08|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.|||-1.08|-38.98|
71789901|NCT02801942|143077640|OTHER||Mean Difference (Final Values)|4.25|STANDARD_ERROR_OF_MEAN|12.739|||TWO_SIDED|95.0|-24.14|32.65|||||The mean difference in CD56lo CD16+ by (Healthy participants versus NOT1D participants) core biopsy method has been presented.|||32.65|-24.14|
71838208|NCT03241459|143183749|SUPERIORITY|||||||0.32||||||P-Value for change in PARC from BL to 1-Month|Wilcoxon (Mann-Whitney)|||||||0.320
71838209|NCT03241459|143183749|SUPERIORITY|||||||0.132||||||P-Value for change in PARC from BL to 6-Months|Wilcoxon (Mann-Whitney)|||||||0.132
71838210|NCT03241459|143183749|SUPERIORITY|||||||0.248||||||P-Value for change in PARC from BL to 12-Months|Wilcoxon (Mann-Whitney)|||||||0.248
71838211|NCT03241459|143183749|SUPERIORITY|||||||0.194||||||P-Value for change in PARC from BL to 24-Months|Wilcoxon (Mann-Whitney)|||||||0.194
71838212|NCT03241459|143183750|SUPERIORITY|||||||0.789||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 6-Months|Fisher Exact|||||||0.789
71838213|NCT03241459|143183750|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71838214|NCT03241459|143183750|SUPERIORITY|||||||0.041||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 12-Months.|Fisher Exact|||||||0.041
71838215|NCT03241459|143183750|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 12-Months.|Fisher Exact|||||||1.0
71838216|NCT03241459|143183750|SUPERIORITY|||||||0.401||||||P-Value for Decrease in Resting Target Limb ABI ≥0.15: BL to 24-Months.|Fisher Exact|||||||0.401
71838217|NCT03241459|143183750|SUPERIORITY|||||||1||||||P-Value for Decrease in Resting Target Limb TBI ≥0.15: BL to 24-Months.|Fisher Exact|||||||1.0
71789902|NCT02801942|143077640|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|2.429|||TWO_SIDED|95.0|-5.54|5.26|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.26|-5.54|
71789903|NCT02801942|143077640|OTHER||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|4.148|||TWO_SIDED|95.0|-12.31|6.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.73|-12.31|
71789904|NCT02801942|143077641|OTHER||Mean Difference (Final Values)|8.25|STANDARD_ERROR_OF_MEAN|7.673|||TWO_SIDED|95.0|-8.58|25.08|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||25.08|-8.58|
71789905|NCT02801942|143077641|OTHER||Mean Difference (Final Values)|16.22|STANDARD_ERROR_OF_MEAN|6.189|||TWO_SIDED|95.0|3.17|29.26|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||29.26|3.17|
71789906|NCT02801942|143077641|OTHER||Mean Difference (Final Values)|-7.89|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|95.0|-31.03|15.25|||||The mean difference in Plasmacytoid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||15.25|-31.03|
71789907|NCT02801942|143077641|OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.781|||TWO_SIDED|95.0|-26.04|-1.66|||||The mean difference in (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-1.66|-26.04|
71838218|NCT03241459|143183751|OTHER|||||||0.995||||||P-value for change in WIQ from BL to 1-Month: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.995
71838219|NCT03241459|143183751|SUPERIORITY|||||||0.158||||||P-value for change in WIQ from BL to 1-month: Walking distance score|Wilcoxon (Mann-Whitney)|||||||0.158
71789908|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|3.561|||TWO_SIDED|95.0|-9.05|5.82|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.82|-9.05|
71789909|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.418|||TWO_SIDED|95.0|-3.13|11.16|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||11.16|-3.13|
71789910|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|1.428|||TWO_SIDED|95.0|-3.14|2.82|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.82|-3.14|
71789911|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|1.851|||TWO_SIDED|95.0|-5.03|2.71|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.71|-5.03|
71789912|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|3.132|||TWO_SIDED|95.0|-8.65|4.43|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.43|-8.65|
71789913|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|3.071|||TWO_SIDED|95.0|-8.0|4.81|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.81|-8.00|
71789914|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|3.51|STANDARD_ERROR_OF_MEAN|6.594|||TWO_SIDED|95.0|-10.21|17.24|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||17.24|-10.21|
71789915|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|7.155|||TWO_SIDED|95.0|-17.1|12.74|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||12.74|-17.10|
71789916|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.708|||TWO_SIDED|95.0|-2.42|0.58|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.58|-2.42|
71789917|NCT02801942|143077643|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.372|||TWO_SIDED|95.0|-1.19|0.35|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.35|-1.19|
71789918|NCT02801942|143077645|OTHER||Mean Difference (Final Values)|-5.39|STANDARD_ERROR_OF_MEAN|2.545|||TWO_SIDED|95.0|-11.56|0.78|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.78|-11.56|
71789919|NCT02801942|143077645|OTHER||Mean Difference (Final Values)|-7.03|STANDARD_ERROR_OF_MEAN|7.114|||TWO_SIDED|95.0|-22.22|8.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy FNA method has been presented.|||8.16|-22.22|
71789920|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.358|||TWO_SIDED|95.0|-0.36|1.14|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.14|-0.36|
71789921|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|95.0|-0.25|0.52|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.52|-0.25|
71789922|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-9.02|8.64|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.64|-9.02|
71789923|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-12.57|5.13|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.13|-12.57|
71838220|NCT03241459|143183751|SUPERIORITY|||||||0.695||||||P-value for change in WIQ from BL to 1-month: Walking speed score|Wilcoxon (Mann-Whitney)|||||||0.695
71838221|NCT03241459|143183751|SUPERIORITY|||||||0.086||||||P-value for change in WIQ from BL to 1-Month: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.086
71838222|NCT03241459|143183751|SUPERIORITY|||||||0.331||||||P-value for change in WIQ from BL to 12-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.331
71838223|NCT03241459|143183751|SUPERIORITY|||||||0.58||||||P-value for change in WIQ from BL to 12-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.580
71838224|NCT03241459|143183751|SUPERIORITY|||||||0.563||||||P-value for change in WIQ from BL to 12-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.563
71757997|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.00|-1.68|<0.0001
71757998|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.76|-2.08|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.08|-2.76|<0.0001
71757999|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.91|||<|0.0001|TWO_SIDED|95.0|-13.21|-10.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-10.60|-13.21|<0.0001
71789924|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|2.25|STANDARD_ERROR_OF_MEAN|4.034|||TWO_SIDED|95.0|-6.16|10.66|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||10.66|-6.16|
71789925|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|3.994|||TWO_SIDED|95.0|-6.27|10.39|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.39|-6.27|
71838225|NCT03241459|143183751|SUPERIORITY|||||||0.27||||||P-value for change in WIQ from BL to 12-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.270
71838226|NCT03241459|143183751|SUPERIORITY|||||||0.869||||||P-value for change in WIQ from BL to 24-Months: Walking Impairment Score|Wilcoxon (Mann-Whitney)|||||||0.869
71892493|NCT01381094|143306465|SUPERIORITY||||||=|0.5867|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5867
71758000|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.23|||<|0.0001|TWO_SIDED|95.0|-8.54|-5.93|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.93|-8.54|<0.0001
71758001|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.59|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-6.59|-9.20|<0.0001
71789926|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|-2.09|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-14.09|9.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.92|-14.09|
71789927|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|4.976|||TWO_SIDED|95.0|-9.91|10.87|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.87|-9.91|
71758002|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.24|||<|0.0001|TWO_SIDED|95.0|-12.55|-9.94|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.94|-12.55|<0.0001
71758003|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.35|||<|0.0001|TWO_SIDED|95.0|-7.65|-5.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-5.05|-7.65|<0.0001
71789928|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.314|||TWO_SIDED|95.0|-0.67|0.65|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.65|-0.67|
71758004|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.36|||<|0.0001|TWO_SIDED|95.0|-11.67|-9.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.05|-11.67|<0.0001
71758005|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.37|||<|0.0001|TWO_SIDED|95.0|-13.16|-9.58|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.58|-13.16|<0.0001
71758006|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.07|||<|0.0001|TWO_SIDED|95.0|-17.86|-14.28|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-14.28|-17.86|<0.0001
71789929|NCT02801942|143077646|OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.325|||TWO_SIDED|95.0|-1.1|0.26|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.26|-1.10|
71789930|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-2.8|16.81|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||16.81|-2.80|
71789931|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|-3.93|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-14.02|6.17|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.17|-14.02|
71838227|NCT03241459|143183751|SUPERIORITY|||||||0.837||||||P-value for change in WIQ from BL to 24-Months: Walking Distance Score|Wilcoxon (Mann-Whitney)|||||||0.837
71838228|NCT03241459|143183751|SUPERIORITY|||||||0.674||||||P-value for change in WIQ for BL to 24-Months: Walking Speed Score|Wilcoxon (Mann-Whitney)|||||||0.674
71838229|NCT03241459|143183751|SUPERIORITY|||||||0.563||||||P-value for change in WIQ for BL to 24-Months: Stair Climbing Score|Wilcoxon (Mann-Whitney)|||||||0.563
71838230|NCT03241459|143183752|SUPERIORITY|||||||0.237||||||P-value for change in 6MWT from BL to 12-Months|t-test, 2 sided|||||||0.237
71838231|NCT03241459|143183752|SUPERIORITY|||||||0.04||||||P-value for change in 6MWT from BL to 24-Months|t-test, 2 sided|||||||0.040
71838232|NCT03241459|143183753|SUPERIORITY|||||||0.772||||||P-value for change in PAQ from BL to 1-Month: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.772
71838233|NCT03241459|143183753|SUPERIORITY|||||||0.93||||||P-value for change in PAQ from BL to 1-Month: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.930
71838234|NCT03241459|143183753|SUPERIORITY|||||||0.546||||||P-value for change in PAQ from BL to 1-Month: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.546
71838235|NCT03241459|143183753|SUPERIORITY|||||||0.621||||||P-value for change in PAQ from BL to 1-Month: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.621
71838236|NCT03241459|143183753|SUPERIORITY|||||||0.133||||||P-value for change in PAQ from BL to 1-Month: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.133
71671850|NCT05344560|142861793|NON_INFERIORITY|A non-inferiority margin of -5 points was used.|Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|2.018|||TWO_SIDED|95.0|-6.92|1.07|||Generalized Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test \[senofilcon A (C3) HEV chromophore\] minus Control \[senofilcon A (C3)\]|||1.07|-6.92|
71671851|NCT00360282|142861794|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Sign test|||||||0.007
71671852|NCT00360282|142861795|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Sign test|||||||.549
71671853|NCT00558467|142861815|SUPERIORITY_OR_OTHER||Least Squares mean difference|0.01||||0.996|TWO_SIDED|95.0|-4.95|4.97|||ANCOVA|||||4.97|-4.95|0.996
71671854|NCT00558467|142861816|SUPERIORITY_OR_OTHER||Least square means difference|-3.94|||||TWO_SIDED|95.0|-5.81|-2.08|||Repeated Measures|||||-2.08|-5.81|
71671855|NCT00558467|142861817|SUPERIORITY_OR_OTHER||Least square means difference|-5.3|||||TWO_SIDED|95.0|-7.21|-3.39|||Repeated measures|||||-3.39|-7.21|
71671856|NCT00558467|142861819|SUPERIORITY_OR_OTHER||Least square means difference|-5.97|||||TWO_SIDED|95.0|-7.88|-4.06|||Repeated measures|||||-4.06|-7.88|
71671857|NCT00558467|142861820|SUPERIORITY_OR_OTHER||Least Squares Mean differnce|-0.15||||0.978|TWO_SIDED|95.0|-11.05|10.75|||ANCOVA|||||10.75|-11.05|0.9780
71671858|NCT00558467|142861825|SUPERIORITY_OR_OTHER|||||||0.1052|||||||Cochran-Mantel-Haenszel|||||||0.1052
71671859|NCT00558467|142861826|SUPERIORITY_OR_OTHER|||||||0.2274|||||||Cochran-Mantel-Haenszel|||||||0.2274
71671860|NCT00558467|142861827|SUPERIORITY_OR_OTHER|||||||0.7691|||||||Cochran-Mantel-Haenszel|||||||0.7691
71671861|NCT00558467|142861828|SUPERIORITY_OR_OTHER|||||||0.0674|||||||Cochran-Mantel-Haenszel|||||||0.0674
71758007|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.73|||<|0.0001|TWO_SIDED|95.0|-13.53|-9.93|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.93|-13.53|<0.0001
71758008|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.71|||<|0.0001|TWO_SIDED|95.0|-17.51|-13.91|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-13.91|-17.51|<0.0001
71758009|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.88|||<|0.0001|TWO_SIDED|95.0|-10.67|-7.09|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.09|-10.67|<0.0001
71758010|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.19|||<|0.0001|TWO_SIDED|95.0|-15.99|-12.39|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-12.39|-15.99|<0.0001
71758011|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.8784|TWO_SIDED|95.0|-3.63|3.11|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.11|-3.63|0.8784
71758012|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.66|||<|0.0001|TWO_SIDED|95.0|-45.02|-38.29|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-38.29|-45.02|<0.0001
71758013|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.63|||<|0.0001|TWO_SIDED|95.0|-23.01|-16.25|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-16.25|-23.01|<0.0001
71758014|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.28|||<|0.0001|TWO_SIDED|95.0|-25.67|-18.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.90|-25.67|<0.0001
71758015|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.5|||<|0.0001|TWO_SIDED|95.0|-15.86|-9.14|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-9.14|-15.86|<0.0001
71758016|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-23.98|-17.21|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.21|-23.98|<0.0001
71758017|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|10.64|||<|0.0001|TWO_SIDED|95.0|5.75|15.54|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.54|5.75|<0.0001
71758018|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.74|||<|0.0001|TWO_SIDED|95.0|-62.63|-52.85|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-52.85|-62.63|<0.0001
71758019|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.18|||<|0.0001|TWO_SIDED|95.0|-27.09|-17.27|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-17.27|-27.09|<0.0001
71758020|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.91|||<|0.0001|TWO_SIDED|95.0|-29.83|-20.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-20.00|-29.83|<0.0001
71758021|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.53|||<|0.0001|TWO_SIDED|95.0|-18.41|-8.64|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-8.64|-18.41|<0.0001
71838237|NCT03241459|143183753|SUPERIORITY|||||||0.592||||||P-value for change in PAQ from BL to 1-Month: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.592
71838238|NCT03241459|143183753|SUPERIORITY|||||||0.601||||||P-value for change in PAQ from BL to 1-Month: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.601
71671862|NCT00558467|142861829|SUPERIORITY_OR_OTHER|||||||0.4944|||||||Cochran-Mantel-Haenszel|||||||0.4944
71671863|NCT00558467|142861830|SUPERIORITY_OR_OTHER|||||||0.162|||||||Cochran-Mantel-Haenszel|||||||0.162
71671864|NCT00558467|142861831|SUPERIORITY_OR_OTHER|||||||0.6375|||||||Cochran-Mantel-Haenszel|||||||0.6375
71671865|NCT00558467|142861832|SUPERIORITY_OR_OTHER|||||||0.6625|||||||Cochran-Mantel-Haenszel|||||||0.6625
71671866|NCT00558467|142861833|SUPERIORITY_OR_OTHER|||||||0.2664|||||||Cochran-Mantel-Haenszel|||||||0.2664
71671867|NCT00558467|142861834|SUPERIORITY_OR_OTHER|||||||0.7302|||||||Cochran-Mantel-Haenszel|||||||0.7302
71671868|NCT00558467|142861835|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
71671869|NCT00558467|142861836|SUPERIORITY_OR_OTHER|||||||0.4852|||||||Cochran-Mantel-Haenszel|||||||0.4852
71671870|NCT00558467|142861837|SUPERIORITY_OR_OTHER|||||||0.4607|||||||Cochran-Mantel-Haenszel|||||||0.4607
71671871|NCT00558467|142861838|SUPERIORITY_OR_OTHER|||||||0.7723|||||||Cochran-Mantel-Haenszel|||||||0.7723
71671872|NCT00558467|142861839|SUPERIORITY_OR_OTHER|||||||0.9389|||||||Cochran-Mantel-Haenszel|||||||0.9389
71671873|NCT02025725|142861847|SUPERIORITY|||||||0.881|||||||ANCOVA|||||||0.881
71671874|NCT02025725|142861848|SUPERIORITY||Mean Difference (Net)|-0.201||||0.036|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 1: metoclopramide nasal spray minus placebo.||||0.036
71671875|NCT02025725|142861848|SUPERIORITY||Mean Difference (Net)|-0.336||||0.025|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 2: metoclopramide nasal spray minus placebo||||0.025
71671876|NCT02025725|142861848|SUPERIORITY||Mean Difference (Net)|-0.347||||0.039|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 3: metoclopramide nasal spray minus placebo.||||0.039
71671877|NCT02025725|142861848|SUPERIORITY||Mean Difference (Net)|-0.364||||0.085|TWO_SIDED||||||ANCOVA|||Change in mean daily GSA total score from Baseline to Week 4: metoclopramide nasal spray minus placebo.||||0.085
71671878|NCT02565628|142861922|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean Difference|-5.02|STANDARD_ERROR_OF_MEAN|10.49||0.6382|ONE_SIDED|90.0||8.97|||Mixed Models Analysis|||||8.97||0.6382
71671879|NCT04227197|142861975|SUPERIORITY|The p value compares the trend in the number of indicated or completed evaluations in the Intervention arm versus Control arm.||||||0.018|||||||Cochran-Armitage trend test|Two tailed; no continuity correction||||||0.018
71671880|NCT04227197|142861977|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group.||||||0.468|||||||ANOVA|||This is the p value for the PedsQL Psychosocial Health Score||||0.468
71671881|NCT04227197|142861977|SUPERIORITY|||||||0.802|||||||ANOVA|||This p value is for the PedsQL Physical Functioning Score||||0.802
71671882|NCT04227197|142861977|SUPERIORITY|||||||0.761|||||||ANOVA|||This is the p value for the PedsQL Total Scale Score||||0.761
71671883|NCT04227197|142861977|SUPERIORITY|||||||0.965|||||||ANOVA|||This is the p value for the PedsQL FIM Parental HRQL Summary Score||||0.965
71671884|NCT04227197|142861977|SUPERIORITY|||||||0.619|||||||ANOVA|||This is the p value for the PedsQL FIM Family Functioning Summary Score||||0.619
71671885|NCT04227197|142861977|SUPERIORITY|||||||0.469|||||||ANOVA|||This is the p value for the PedsQL FIM Total Scale Score||||0.469
71671886|NCT04227197|142861978|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.068|||||||ANOVA|||This is for the change from baseline on PedsQL Psychosocial Health Score||||0.068
71671887|NCT04227197|142861978|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.907|||||||ANOVA|||This is for the change from baseline for PedsQL Physical Functioning Score||||0.907
71671888|NCT04227197|142861978|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.196|||||||ANOVA|||This is for the change from baseline for PedsQL Total Scale Score||||0.196
71671889|NCT04227197|142861978|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.112|||||||ANOVA|||This is for the change from baseline for PedsQL FIM Parental HRQL Summary Score||||0.112
71671890|NCT04227197|142861978|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.245|||||||ANOVA|||This is for change from baseline for PedsQL FIM Family Functioning Summary Score||||0.245
71671891|NCT04227197|142861978|SUPERIORITY|The p value compares the change from baseline on quality of life measures between the Intervention group and Control group||||||0.219|||||||ANOVA|||This is for change from baseline for PedsQL FIM Total Scale Score||||0.219
71671892|NCT00333983|142861980|SUPERIORITY_OR_OTHER|||||||0.025||||||P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.|Mixed Models Analysis|||An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.||||.025
71671893|NCT00833105|142861981|SUPERIORITY_OR_OTHER||||||<|0.025|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||<0.025
71671894|NCT00833105|142861982|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.299
71671895|NCT00833105|142861983|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.459
71671896|NCT00833105|142861984|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.343
71671897|NCT00833105|142861985|SUPERIORITY_OR_OTHER|||||||0.951|TWO_SIDED||||||Mixed Models Analysis|Random subject effects||||||0.951
71671898|NCT00833105|142861986|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.371
71671899|NCT00833105|142861987|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||Mixed Models Analysis|Random subject effect||||||0.164
71671900|NCT00833105|142861988|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon Signed-Rank|No multiple comparison procedure||Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.||||<0.01
71671901|NCT00833105|142861989|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||No multiple comparison procedure performed|Wilcoxon Signed Rank Test|||||||<0.05
71671902|NCT00833105|142861990|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||No multiple comparison procedure|Wilcoxon Signed Rank Test|||||||<0.0001
71671903|NCT00833105|142861991|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.005
71671904|NCT00833105|142861992|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
71789932|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.651|||TWO_SIDED|95.0|-2.69|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.16|-2.69|
71789933|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.507|||TWO_SIDED|95.0|-3.21|3.24|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.24|-3.21|
71789934|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-2.78|4.33|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.33|-2.78|
71789935|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.339|||TWO_SIDED|95.0|-2.75|2.85|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.85|-2.75|
71789936|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|3.631|||TWO_SIDED|95.0|-8.56|6.63|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.63|-8.56|
71789937|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|-6.03|STANDARD_ERROR_OF_MEAN|2.708|||TWO_SIDED|95.0|-11.69|-0.38|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||-0.38|-11.69|
71789938|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.889|||TWO_SIDED|95.0|-1.98|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.78|-1.98|
71789939|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.787|||TWO_SIDED|95.0|-1.07|2.24|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.24|-1.07|
71789940|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.613|||TWO_SIDED|95.0|-0.85|1.72|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.72|-0.85|
71789941|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|95.0|-0.8|1.56|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.56|-0.80|
71789942|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|1.546|||TWO_SIDED|95.0|-2.71|3.76|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.76|-2.71|
71789943|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.95|3.79|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|-2.95|
71789944|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.356|||TWO_SIDED|95.0|-4.84|9.14|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.14|-4.84|
71789945|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|2.481|||TWO_SIDED|95.0|-1.25|9.15|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||9.15|-1.25|
71789946|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.627|||TWO_SIDED|95.0|-1.28|1.38|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.38|-1.28|
71789947|NCT02801942|143077647|OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.438|||TWO_SIDED|95.0|-0.93|0.91|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.91|-0.93|
71789948|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-7.4|8.0|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.00|-7.40|
71789949|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.694|||TWO_SIDED|95.0|-4.9|6.35|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.35|-4.90|
71789950|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.377|||TWO_SIDED|95.0|-9.89|0.08|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||0.08|-9.89|
71789951|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-3.29|STANDARD_ERROR_OF_MEAN|1.682|||TWO_SIDED|95.0|-6.82|0.24|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||0.24|-6.82|
71789952|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|95.0|-2.67|2.1|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.10|-2.67|
71789953|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.929|||TWO_SIDED|95.0|-7.2|1.59|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.59|-7.20|
71789954|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|2.117|||TWO_SIDED|95.0|-5.98|3.11|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.11|-5.98|
71671905|NCT00833105|142861993|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||No multiple comparisons adjustment.|Wilcoxon Signed Rank Test|||||||<0.001
71671906|NCT02992236|142862053|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71789955|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.047|||TWO_SIDED|95.0|-4.59|3.99|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.99|-4.59|
71838239|NCT03241459|143183753|SUPERIORITY|||||||0.185||||||P-value for change in PAQ from BL to 12-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.185
71838240|NCT03241459|143183753|SUPERIORITY|||||||0.856||||||P-value for change in PAQ from BL to 12-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.856
71789956|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|2.645|||TWO_SIDED|95.0|-6.99|4.06|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.06|-6.99|
71789957|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|2.185|||TWO_SIDED|95.0|-4.05|5.11|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.11|-4.05|
71789958|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|4.299|||TWO_SIDED|95.0|-11.23|6.73|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.73|-11.23|
71789959|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|3.42|STANDARD_ERROR_OF_MEAN|3.472|||TWO_SIDED|95.0|-3.84|10.67|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.67|-3.84|
71789960|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|1.153|||TWO_SIDED|95.0|-3.3|2.0|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.00|-3.30|
71789961|NCT02801942|143077648|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.869|||TWO_SIDED|95.0|-2.06|1.72|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.72|-2.06|
71789962|NCT02801942|143077649|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|1.304|||TWO_SIDED|95.0|-2.27|3.19|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||3.19|-2.27|
71789963|NCT02801942|143077649|OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.056|||TWO_SIDED|95.0|-3.24|1.36|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||1.36|-3.24|
71789964|NCT02801942|143077650|OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|5.069|||TWO_SIDED|95.0|-11.91|9.58|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.58|-11.91|
71789965|NCT02801942|143077650|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|5.301|||TWO_SIDED|95.0|-15.85|7.1|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.10|-15.85|
71789966|NCT02801942|143077650|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.374|||TWO_SIDED|95.0|-1.62|4.59|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.59|-1.62|
71789967|NCT02801942|143077650|OTHER||Mean Difference (Final Values)|2.91|STANDARD_ERROR_OF_MEAN|1.291|||TWO_SIDED|95.0|-0.05|5.88|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||5.88|-0.05|
71789968|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|4.86|STANDARD_ERROR_OF_MEAN|3.083|||TWO_SIDED|95.0|-1.6|11.31|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||11.31|-1.60|
71789969|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|8.21|STANDARD_ERROR_OF_MEAN|6.78|||TWO_SIDED|95.0|-6.15|22.57|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||22.57|-6.15|
71789970|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|-11.19|STANDARD_ERROR_OF_MEAN|5.812|||TWO_SIDED|95.0|-23.48|1.11|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||1.11|-23.48|
71789971|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|-5.89|STANDARD_ERROR_OF_MEAN|3.855|||TWO_SIDED|95.0|-14.14|2.37|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.37|-14.14|
71789972|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|1.65|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-3.54|6.84|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.84|-3.54|
71789973|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|2.937|||TWO_SIDED|95.0|-3.84|8.98|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||8.98|-3.84|
71789974|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|2.781|||TWO_SIDED|95.0|-2.67|9.12|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||9.12|-2.67|
71789975|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|3.38|STANDARD_ERROR_OF_MEAN|1.337|||TWO_SIDED|95.0|0.55|6.21|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.21|0.55|
71789976|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|4.736|||TWO_SIDED|95.0|-11.49|8.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.58|-11.49|
71789977|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|1.88|STANDARD_ERROR_OF_MEAN|4.142|||TWO_SIDED|95.0|-6.81|10.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||10.58|-6.81|
71789978|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|10.45|STANDARD_ERROR_OF_MEAN|5.79|||TWO_SIDED|95.0|-2.01|22.92|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||22.92|-2.01|
71789979|NCT02801942|143077651|OTHER||Mean Difference (Final Values)|6.17|STANDARD_ERROR_OF_MEAN|4.913|||TWO_SIDED|95.0|-4.24|16.59|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||16.59|-4.24|
71789980|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.696|||TWO_SIDED|95.0|-0.08|2.83|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.83|-0.08|
71789981|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.324|||TWO_SIDED|95.0|-0.61|4.98|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.98|-0.61|
71838241|NCT03241459|143183753|SUPERIORITY|||||||0.541||||||P-value for change in PAQ from BL to 12-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.541
71789982|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|6.389|||TWO_SIDED|95.0|-14.66|12.85|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||12.85|-14.66|
71789983|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|-4.19|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|-14.71|6.33|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.33|-14.71|
71789984|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.234|||TWO_SIDED|95.0|-2.73|2.47|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||2.47|-2.73|
71789985|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.859|||TWO_SIDED|95.0|-1.45|2.28|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||2.28|-1.45|
71789986|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|0.64|5.78|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||5.78|0.64|
71789987|NCT02801942|143077652|OTHER||Mean Difference (Final Values)|2.27|STANDARD_ERROR_OF_MEAN|0.712|||TWO_SIDED|95.0|0.75|3.79|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.79|0.75|
71789988|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|0.4|6.15|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||6.15|0.40|
71789989|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|2.109|||TWO_SIDED|95.0|-1.68|7.17|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||7.17|-1.68|
71789990|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|6.712|||TWO_SIDED|95.0|-14.49|14.48|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||14.48|-14.49|
71789991|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.947|||TWO_SIDED|95.0|-12.67|4.43|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||4.43|-12.67|
71838242|NCT03241459|143183753|SUPERIORITY|||||||0.731||||||P-value for change in PAQ from BL to 12-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.731
71838243|NCT03241459|143183753|SUPERIORITY|||||||0.696||||||P-value for change in PAQ from BL to 12-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.696
71838244|NCT03241459|143183753|SUPERIORITY|||||||0.716||||||P-value for change in PAQ from BL to 12-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.716
71838245|NCT03241459|143183753|SUPERIORITY|||||||0.797||||||P-value for change in PAQ from BL to 12-Months: Summary Score|Wilcoxon (Mann-Whitney)|||||||0.797
71838246|NCT03241459|143183753|SUPERIORITY|||||||0.29||||||P-value for change in PAQ from BL to 24-Months: Physical Function Score|Wilcoxon (Mann-Whitney)|||||||0.290
71838247|NCT03241459|143183753|SUPERIORITY|||||||0.473||||||P-value for change in PAQ from BL to 24-Months: Stability Score|Wilcoxon (Mann-Whitney)|||||||0.473
71838248|NCT03241459|143183753|SUPERIORITY|||||||0.278||||||P-value for change in PAQ from BL to 24-Months: Symptom Score|Wilcoxon (Mann-Whitney)|||||||0.278
71677217|NCT04143594|142873012|SUPERIORITY||Difference in LSM|-12.0||||0.7963|TWO_SIDED|95.0|-106.0|81.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||81|-106|0.7963
71789992|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|1.33|STANDARD_ERROR_OF_MEAN|2.967|||TWO_SIDED|95.0|-5.48|8.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||8.13|-5.48|
71789993|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|2.287|||TWO_SIDED|95.0|-4.36|6.84|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||6.84|-4.36|
71789994|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|95.0|0.54|4.84|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.|||4.84|0.54|
71789995|NCT02801942|143077653|OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.737|||TWO_SIDED|95.0|0.03|3.13|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.|||3.13|0.03|
71789996|NCT03182829|143077696|NON_INFERIORITY|non-inferiority was chosen|Mean Difference (Final Values)|100.0|||<|0.05|TWO_SIDED|95.0|90.0|100.0|||Chi-squared||||Fisher's exact test|100|90|<0.05
71789997|NCT00254540|143077697|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|48.0||||||95.0|27.8|68.7||||||||68.7|27.8|
71789998|NCT00254540|143077697|SUPERIORITY_OR_OTHER||Objective Response Rate(percentage)|46.2||||||95.0|26.6|66.6||||||||66.6|26.6|
71789999|NCT00225251|143077713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.05|||||||t-test, 2 sided|||||||<.05
71838249|NCT03241459|143183753|SUPERIORITY|||||||0.974||||||P-value for change in PAQ from BL to 24-Months: Treatment Satisfaction Score|Wilcoxon (Mann-Whitney)|||||||0.974
71838250|NCT03241459|143183753|SUPERIORITY|||||||0.266||||||P-value for change in PAQ from BL to 24-Months: Quality of Life Score|Wilcoxon (Mann-Whitney)|||||||0.266
71838251|NCT03241459|143183753|SUPERIORITY|||||||0.656||||||P-value for change in PAQ from BL to 24-Months: Social Limitation Score|Wilcoxon (Mann-Whitney)|||||||0.656
71838252|NCT03241459|143183753|SUPERIORITY|||||||0.959||||||P-value for change in PAQ from BL to 12-Months:Summary Score|Wilcoxon (Mann-Whitney)|||||||0.959
71838253|NCT03241459|143183754|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
71838254|NCT03241459|143183754|SUPERIORITY|||||||0.903||||||P-Value at 48-Months|Fisher Exact|||||||0.903
71838255|NCT03241459|143183754|SUPERIORITY|||||||1||||||P-Value at 60-Months|Fisher Exact|||||||1.0
71838256|NCT03241459|143183755|SUPERIORITY|||||||0.913|||||||Fisher Exact|P-Value at 36-Months||||||0.913
71838257|NCT03241459|143183755|SUPERIORITY|||||||1|||||||Fisher Exact|P-Value at 48-Months||||||1.0
71671907|NCT03446027|142862056|OTHER|"Prespecified Tobit Regression mode: the model included the AWD baseline measurement, a treatment indicator and the type of centre (SET versus non-SET) as covariates. As the data collected for AWD showed a right-skewed distribution, a square root transformation was used to normalise the data and used for the regression Tobit model. This resulted in the unit of measure being units rather than meters."|square root transformation|0.835||||0.28|TWO_SIDED|95.0|-0.674|2.343|||Tobit Regression|||"Right censored Tobit regression model for AWD at 3 months for the ITT population.~Difference between arms (between baseline and 3 months) - the primary analysis estimates the difference in the AWD at 3 months between the two treatment groups control vs. device. Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET Included participants with both baseline and 3 month treadmill data."||2.343|-0.674|0.28
71758022|NCT01746901|143018555|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.7|||<|0.0001|TWO_SIDED|95.0|-28.62|-18.78|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-18.78|-28.62|<0.0001
71758023|NCT01746901|143018556|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|||<|0.0001|TWO_SIDED|95.0|-11.9|-7.57|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-7.57|-11.90|<0.0001
71758024|NCT01746901|143018556|SUPERIORITY_OR_OTHER||LS Mean Difference|5.16|||<|0.0001|TWO_SIDED|95.0|2.99|7.32|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||7.32|2.99|<0.0001
71758025|NCT01746901|143018556|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.9766|TWO_SIDED|95.0|-2.13|2.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.20|-2.13|0.9766
71758026|NCT01746901|143018556|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.61|||<|0.0001|TWO_SIDED|95.0|-6.78|-2.44|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.44|-6.78|<0.0001
71758027|NCT01746901|143018556|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39||||0.7242|TWO_SIDED|95.0|-2.55|1.78|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.78|-2.55|0.7242
71758028|NCT01746901|143018556|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.45|||<|0.0001|TWO_SIDED|95.0|-6.62|-2.28|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-2.28|-6.62|<0.0001
71758029|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|19.0|||<|0.0001|TWO_SIDED|95.0|14.6|23.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||23.5|14.6|<0.0001
71758030|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.8048|TWO_SIDED|95.0|-3.9|5.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||5.0|-3.9|0.8048
71758031|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6||||0.0002|TWO_SIDED|95.0|4.2|13.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||13.1|4.2|0.0002
71838258|NCT03241459|143183755|SUPERIORITY|||||||0.839||||||P-Value at 60-Months|Fisher Exact|||||||0.839
71758032|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||15.4|6.5|<0.0001
71758033|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1||||0.0019|TWO_SIDED|95.0|2.7|11.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||11.6|2.7|0.0019
71758034|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6||||0.001|TWO_SIDED|95.0|3.2|12.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||12.1|3.2|0.0010
71758035|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|127.4|||<|0.0001|TWO_SIDED|95.0|93.6|161.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||161.2|93.6|<0.0001
71838259|NCT03241459|143183756|SUPERIORITY|||||||1||||||P-Value at 36-Months|Fisher Exact|||||||1.0
71758036|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|4.7||||0.7837|TWO_SIDED|95.0|-29.1|38.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||38.5|-29.1|0.7837
71758037|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|65.8||||0.0002|TWO_SIDED|95.0|32.0|99.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||99.6|32.0|0.0002
71758038|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|66.3||||0.0002|TWO_SIDED|95.0|32.5|100.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||100.1|32.5|0.0002
71758039|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|60.3||||0.0006|TWO_SIDED|95.0|26.5|94.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||94.1|26.5|0.0006
71838260|NCT03241459|143183756|SUPERIORITY|||||||0.5|||||||Fisher Exact|P-Value at 48-Months||||||0.5
71838261|NCT03241459|143183756|SUPERIORITY|||||||0.251|||||||Fisher Exact|P-Value at 60-Months||||||0.251
71838262|NCT03241459|143183757|SUPERIORITY|||||||0.478||||||P-Value at 36-Months|Fisher Exact|||||||0.478
71838263|NCT03241459|143183757|SUPERIORITY|||||||0.605||||||P-Value at 48-Months|Fisher Exact|||||||0.605
71838264|NCT03241459|143183757|SUPERIORITY|||||||0.345||||||P-Value at 60-Months|Fisher Exact|||||||0.345
71671908|NCT03446027|142862057|OTHER|"Right censored, Tobit Regression model to assess the effects of baseline characteristics for ICD at 3 months for the ITT Population. This resulted in the unit of measure being units and not meters.~Included participants with both baseline and 3 month treadmill data. Calculation between arms - estimates the difference in the ICD at 3 months between the two treatment groups.~Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET"|square root transformation|0.972||||0.23|TWO_SIDED|95.0|-0.6|2.546|||Right censored, Tobit Regression|||||2.546|-0.600|0.23
71671909|NCT03446027|142862061|OTHER|"Linear Regression Model for Duplex ultrasonography (Volume flow - measured in one leg) at 3 months for the ITT population.~Difference (calculation) between the two groups and not per arm (control vs treatment). Unit of measure is Units due to the use of a linear regression model rather than cc/min."|Linear regression|0.483||||0.516|TWO_SIDED|95.0|-0.984|1.95|||Regression, Linear|||||1.950|-0.984|0.516
71671910|NCT04556305|142862163|SUPERIORITY|||||||0.409|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.409
71671911|NCT04556305|142862163|SUPERIORITY|||||||0.456|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.456
71671912|NCT04556305|142862163|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.692
71671913|NCT04556305|142862164|SUPERIORITY|||||||0.179|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.179
71671914|NCT04556305|142862164|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.910
71671915|NCT04556305|142862164|SUPERIORITY|||||||0.159|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.159
71671916|NCT04556305|142862165|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
71671917|NCT04556305|142862165|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
71671918|NCT04556305|142862165|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
71671919|NCT04556305|142862166|SUPERIORITY|||||||0.772|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.772
71671920|NCT04556305|142862166|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.107
71671921|NCT04556305|142862166|SUPERIORITY|||||||0.915|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.915
71671922|NCT04556305|142862167|SUPERIORITY|||||||0.078|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.078
71671923|NCT04556305|142862167|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.130
71671924|NCT04556305|142862167|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.430
71671925|NCT04556305|142862168|SUPERIORITY|||||||0.487|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.487
71671926|NCT04556305|142862168|SUPERIORITY|||||||0.827|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.827
71671927|NCT04556305|142862168|SUPERIORITY|||||||0.908|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.908
71671928|NCT04556305|142862169|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.371
71671929|NCT04556305|142862169|SUPERIORITY|||||||0.633|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.633
71671930|NCT04556305|142862169|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.230
71671931|NCT04556305|142862170|SUPERIORITY|||||||0.798|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.798
71671932|NCT04556305|142862170|SUPERIORITY|||||||0.461|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.461
71671933|NCT04556305|142862170|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.419
71671934|NCT04556305|142862171|SUPERIORITY|||||||0.619|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.619
71671935|NCT04556305|142862171|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.468
71671936|NCT04556305|142862171|SUPERIORITY|||||||0.387|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.387
71671937|NCT04556305|142862172|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.380
71671938|NCT04556305|142862172|SUPERIORITY|||||||0.759|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.759
71671939|NCT04556305|142862172|SUPERIORITY|||||||0.219|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.219
71671940|NCT04556305|142862173|SUPERIORITY|||||||0.995|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.995
71671941|NCT04556305|142862173|SUPERIORITY|||||||0.946|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.946
71671942|NCT04556305|142862173|SUPERIORITY|||||||0.593|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.593
71671943|NCT04556305|142862174|SUPERIORITY|||||||0.092|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.092
71671944|NCT04556305|142862174|SUPERIORITY|||||||0.245|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.245
71671945|NCT04556305|142862174|SUPERIORITY|||||||0.107|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.107
71671946|NCT04556305|142862175|SUPERIORITY|||||||0.244|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.244
71671947|NCT04556305|142862175|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.085
71758040|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|31.9||||0.064|TWO_SIDED|95.0|-1.9|65.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||65.7|-1.9|0.0640
71758041|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|142.6|||<|0.0001|TWO_SIDED|95.0|94.5|190.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||190.7|94.5|<0.0001
71838265|NCT04541147|143183766|EQUIVALENCE|Test if the number of doses in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|6.9|STANDARD_DEVIATION|10.1||0.16|TWO_SIDED|95.0|-2.9|16.7|||t-test, 2 sided|||||16.7|-2.9|0.16
71671948|NCT04556305|142862175|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.710
71671949|NCT04556305|142862176|SUPERIORITY|||||||0.491|||||||Mixed Models Analysis|||Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over time||||.491
71671950|NCT04556305|142862176|SUPERIORITY|||||||0.444|||||||Mixed Models Analysis|||Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over time||||.444
71671951|NCT04556305|142862176|SUPERIORITY|||||||0.279|||||||Mixed Models Analysis|||Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over time||||.279
71671952|NCT03808948|142862184|OTHER||Odds Ratio (OR)|0.62||||0.4842|TWO_SIDED|95.0|0.08|1.97|||Regression, Logistic|||Binary logistic regression with mGFR/eGFR ratio as independent variate, AKI as binary outcome||1.97|0.08|0.4842
71758042|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|15.8||||0.5169|TWO_SIDED|95.0|-32.3|63.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||63.9|-32.3|0.5169
71671953|NCT00568451|142862200|SUPERIORITY_OR_OTHER||Median|12.5|||||ONE_SIDED|95.0|4.5||||Kaplan-Meier||||||4.5|
71671954|NCT03982511|142862205|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given that this is a pilot RCT, primary aim is to estimate effect sizes for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
71671955|NCT03982511|142862205|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI z-score from T3 to T1|Effect size: -0.01|||.98
71671956|NCT03982511|142862205|SUPERIORITY||Mean Difference (Net)|1.93|STANDARD_ERROR_OF_MEAN|3.97||0.63|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T2 to T1|Effect size: 0.24|||0.63
71671957|NCT03982511|142862205|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|4.51||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for BMI percentile from T3 to T1|Effect size: 0.03|||0.96
71671958|NCT03982511|142862206|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for Emotion regulation subscale from T2 to T1|Effect size: 0.79|||0.12
71671959|NCT03982511|142862206|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.96|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for emotion regulation subscale from T3 to T1|Effect size: -0.02|||0.96
71671960|NCT03982511|142862207|SUPERIORITY||Mean Difference (Net)|-6.08|STANDARD_ERROR_OF_MEAN|5.42||0.28|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T2 to T1|Effect size: -0.41|||0.28
71671961|NCT03982511|142862207|SUPERIORITY||Mean Difference (Net)|5.83|STANDARD_ERROR_OF_MEAN|7.17||0.43|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for child weekly screen time from T3 to T1|Effect size: 0.42|||0.43
71671962|NCT03982511|142862208|SUPERIORITY||Mean Difference (Net)|35.32|STANDARD_ERROR_OF_MEAN|23.86||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T2 to T1|Effect size: 0.85|||0.16
71671963|NCT03982511|142862208|SUPERIORITY|Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|Mean Difference (Net)|16.09|STANDARD_ERROR_OF_MEAN|30.32||0.61|TWO_SIDED||||||ANOVA|Repeated measures||Difference on difference score for MVPA minutes from T3 to T1|Effect size: 0.35|||0.61
71671964|NCT03982511|142862208|SUPERIORITY||Mean Difference (Net)|-64.4|STANDARD_ERROR_OF_MEAN|54.5||0.26|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference score for sedentary minutes from T2 to T1|Effect size: -0.68|||0.26
71671965|NCT03982511|142862208|SUPERIORITY||Mean Difference (Net)|66.25|STANDARD_ERROR_OF_MEAN|66.43||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference score for sedentary minutes from T3 to T1|effect size: 0.66|||0.34
71671966|NCT03982511|142862209|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|0.75||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T2 to T1|effect size: -0.41|||0.41
71790000|NCT01313767|143077736|NON_INFERIORITY_OR_EQUIVALENCE|90% of the power, 0.45 of non-inferiority margin|Mean Difference (Final Values)|0.17||||0.1347|TWO_SIDED|95.0|-0.05|0.4|||t-test, 2 sided|||The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.||0.40|-0.05|0.1347
71671967|NCT03982511|142862209|SUPERIORITY||Mean Difference (Net)|1.39|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for parent-reported sleep time from T3 to T1|effect size: 0.76|||0.16
71790001|NCT01313767|143077737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.2591|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.||||0.2591
71671968|NCT03982511|142862210|SUPERIORITY||Mean Difference (Net)|-12.62|STANDARD_ERROR_OF_MEAN|14.84||0.42|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T2 to T1|effect size: -0.54|||0.42
71671969|NCT03982511|142862210|SUPERIORITY||Mean Difference (Net)|-38.83|STANDARD_ERROR_OF_MEAN|16.61||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for actigraphy-recorded sleep time from T3 to T1|effect size: -1.56|||0.04
71790002|NCT01313767|143077737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.3395|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.||||0.3395
71671970|NCT03982511|142862211|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T2 to T1|effect size: 0.15|||0.77
71671971|NCT03982511|142862211|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.28||0.47|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for problematic media use from T3 to T1|effect size: -0.38|||0.47
71671972|NCT03982511|142862212|SUPERIORITY||Mean Difference (Net)|9.11|STANDARD_ERROR_OF_MEAN|2.76||0.005|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T2 to T1|effect size: 1.65|||0.005
71790003|NCT01313767|143077738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0675|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.||||0.0675
71790004|NCT01313767|143077738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0605|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.||||0.0605
71790005|NCT01313767|143077738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.0429|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.||||0.0429
71790006|NCT01313767|143077739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.6954|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.||||0.6954
71790007|NCT01313767|143077739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.6024|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.||||0.6024
71790008|NCT01313767|143077739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.9316|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.||||0.9316
71790009|NCT01313767|143077740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.2284|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.||||0.2284
71790010|NCT01313767|143077740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.3221|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.||||0.3221
71758043|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3||||0.0011|TWO_SIDED|95.0|33.2|129.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||129.3|33.2|0.0011
71758044|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|77.1||||0.0018|TWO_SIDED|95.0|29.1|125.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||125.2|29.1|0.0018
71758045|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|63.6||||0.0098|TWO_SIDED|95.0|15.6|111.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||111.7|15.6|0.0098
71758046|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|39.4||||0.1078|TWO_SIDED|95.0|-8.7|87.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||87.4|-8.7|0.1078
71758047|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|116.9|275.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||275.1|116.9|<0.0001
71758048|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.9726|TWO_SIDED|95.0|-77.7|80.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||80.5|-77.7|0.9726
71758049|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|114.1||||0.005|TWO_SIDED|95.0|35.0|193.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.2|35.0|0.0050
71758050|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|83.3||||0.0392|TWO_SIDED|95.0|4.2|162.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||162.4|4.2|0.0392
71758051|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|68.7||||0.0883|TWO_SIDED|95.0|-10.4|147.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||147.8|-10.4|0.0883
71758052|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|64.4||||0.11|TWO_SIDED|95.0|-14.7|143.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||143.5|-14.7|0.1100
71758053|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|242.9|||<|0.0001|TWO_SIDED|95.0|138.6|347.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||347.2|138.6|<0.0001
71758054|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.0||||0.6906|TWO_SIDED|95.0|-125.3|83.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||83.2|-125.3|0.6906
71758055|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7||||0.0259|TWO_SIDED|95.0|14.5|223.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||223.0|14.5|0.0259
71790011|NCT01313767|143077740|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.593|TWO_SIDED||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.||||0.5930
71790012|NCT01313767|143077741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.1585|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.1585
71838266|NCT04541147|143183767|EQUIVALENCE|Test if the average pain score in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|1.4||0.56|TWO_SIDED|95.0|-1.8|1.0|||t-test, 2 sided|||||1.0|-1.8|0.56
71758056|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|103.2||||0.0525|TWO_SIDED|95.0|-1.1|207.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||207.5|-1.1|0.0525
71758057|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|60.2||||0.2558|TWO_SIDED|95.0|-44.1|164.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||164.4|-44.1|0.2558
71758058|NCT01746901|143018557|SUPERIORITY_OR_OTHER||LS Mean Difference|88.6||||0.0952|TWO_SIDED|95.0|-15.7|192.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||192.9|-15.7|0.0952
71758059|NCT01746901|143018558|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0298|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-0.2|-3.3|0.0298
71758060|NCT01746901|143018558|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.3|1.1|0.0008
71758061|NCT01746901|143018558|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.645|TWO_SIDED|95.0|-2.0|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-2.0|0.6450
71790013|NCT01313767|143077741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0028||||0.9596|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.9596
71790014|NCT01313767|143077741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0304||||0.6164|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.||||0.6164
71758062|NCT01746901|143018558|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0962|TWO_SIDED|95.0|-0.2|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||2.9|-0.2|0.0962
71758063|NCT01746901|143018558|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.193|TWO_SIDED|95.0|-2.6|0.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||0.5|-2.6|0.1930
71758064|NCT01746901|143018558|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.031|TWO_SIDED|95.0|0.2|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||3.3|0.2|0.0310
71758065|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|41.5|||<|0.0001|TWO_SIDED|95.0|33.9|49.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||49.0|33.9|<0.0001
71758066|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4||||0.3763|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||10.9|-4.2|0.3763
71758067|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|18.3|||<|0.0001|TWO_SIDED|95.0|10.7|25.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||25.8|10.7|<0.0001
71758068|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||34.1|19.1|<0.0001
71758069|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.1|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||28.2|13.1|<0.0001
71758070|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|11.8|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||26.8|11.8|<0.0001
71758071|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|284.3|||<|0.0001|TWO_SIDED|95.0|232.9|335.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||335.8|232.9|<0.0001
71758072|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|31.2||||0.2336|TWO_SIDED|95.0|-20.4|82.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||82.8|-20.4|0.2336
71758073|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|167.3|||<|0.0001|TWO_SIDED|95.0|115.7|218.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||218.9|115.7|<0.0001
71758074|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|148.3|||<|0.0001|TWO_SIDED|95.0|96.8|199.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||199.7|96.8|<0.0001
71758075|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|135.6|||<|0.0001|TWO_SIDED|95.0|84.0|187.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||187.2|84.0|<0.0001
71671973|NCT03982511|142862212|SUPERIORITY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.81||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for child-centered skills from T3 to T1|effect size: 1.20|||0.05
71758076|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|113.6|||<|0.0001|TWO_SIDED|95.0|62.1|165.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||165.0|62.1|<0.0001
71758077|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|278.3|||<|0.0001|TWO_SIDED|95.0|213.2|343.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||343.3|213.2|<0.0001
71758078|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|71.3||||0.0322|TWO_SIDED|95.0|6.1|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||136.5|6.1|0.0322
71790015|NCT01313767|143077742|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.1802|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1802
71758079|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|195.4|||<|0.0001|TWO_SIDED|95.0|130.2|260.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||260.5|130.2|<0.0001
71758080|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|154.3|||<|0.0001|TWO_SIDED|95.0|89.2|219.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||219.3|89.2|<0.0001
71758081|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|143.2|||<|0.0001|TWO_SIDED|95.0|78.0|208.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||208.4|78.0|<0.0001
71758082|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|126.7||||0.0002|TWO_SIDED|95.0|61.7|191.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||191.8|61.7|0.0002
71671974|NCT03982511|142862213|SUPERIORITY||Mean Difference (Net)|-17.23|STANDARD_ERROR_OF_MEAN|6.93||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T2 to T1.|effect size: -1.21|||0.02
71838267|NCT04541147|143183768|EQUIVALENCE|Test if the Number of participants with post-operative complications in Dexamethasone Plus Analgesics group differs from that in Analgesics Alone group at a significance level of 0.05.|Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.15||1|TWO_SIDED|95.0|-0.22|0.36|||Fisher Exact|||||0.36|-0.22|1.00
71671975|NCT03982511|142862213|SUPERIORITY||Mean Difference (Net)|-19.43|STANDARD_ERROR_OF_MEAN|6.4||0.008|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PCDI scores from T3 to T1|effect size: -1.57|||0.008
71671976|NCT03982511|142862214|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.36||0.5|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for pressure to eat scores from T2 to T1|effect size: -0.34|||0.50
71838268|NCT04064164|143183786|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.004||||||Dear (root word)|Chi-squared|X-squared = 8.4 df=1||||||.004
71671977|NCT03982511|142862214|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.37||0.98|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for pressure to eat scores from T3 to T1|effect size: -0.01|||0.98
71671978|NCT03982511|142862215|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.32||0.17|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T2 to T1|effect size: -0.70|||0.17
71671979|NCT03982511|142862215|SUPERIORITY||Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.35||0.34|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive feeding scores from T3 to T1|effect size: -0.51|||0.34
71758083|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|202.4|||<|0.0001|TWO_SIDED|95.0|118.4|286.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||286.4|118.4|<0.0001
71758084|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|137.6||||0.0015|TWO_SIDED|95.0|53.3|221.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||221.8|53.3|0.0015
71758085|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|192.9|||<|0.0001|TWO_SIDED|95.0|108.7|277.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||277.2|108.7|<0.0001
71758086|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0||||0.0007|TWO_SIDED|95.0|63.0|231.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||231.1|63.0|0.0007
71758087|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|148.1||||0.0007|TWO_SIDED|95.0|63.9|232.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||232.4|63.9|0.0007
71758088|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|109.6||||0.011|TWO_SIDED|95.0|25.5|193.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||193.6|25.5|0.0110
71758089|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|196.0|||<|0.0001|TWO_SIDED|95.0|107.4|284.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||284.6|107.4|<0.0001
71758090|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|133.9||||0.0034|TWO_SIDED|95.0|45.0|222.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||222.8|45.0|0.0034
71758091|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|190.9|||<|0.0001|TWO_SIDED|95.0|102.1|279.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||279.8|102.1|<0.0001
71758092|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|138.9||||0.0023|TWO_SIDED|95.0|50.3|227.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||227.6|50.3|0.0023
71758093|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|147.8||||0.0013|TWO_SIDED|95.0|59.0|236.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||236.7|59.0|0.0013
71758094|NCT01746901|143018559|SUPERIORITY_OR_OTHER||LS Mean Difference|100.0||||0.0273|TWO_SIDED|95.0|11.3|188.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||188.6|11.3|0.0273
71758095|NCT01746901|143018560|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-1.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||-1.8|-5.0|<0.0001
71758096|NCT01746901|143018560|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0004|TWO_SIDED|95.0|1.3|4.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||4.4|1.3|0.0004
71758097|NCT01746901|143018560|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.8478|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8478
71758098|NCT01746901|143018560|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.6192|TWO_SIDED|95.0|-1.9|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.2|-1.9|0.6192
71758099|NCT01746901|143018560|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8857|TWO_SIDED|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.4|-1.7|0.8857
71758100|NCT01746901|143018560|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.5092|TWO_SIDED|95.0|-2.1|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.||1.0|-2.1|0.5092
71758101|NCT02683577|143018573|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|1.695|||||TWO_SIDED|90.0|0.904|3.176|||||A repeated-measures analysis of variance (ANOVA) was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.176|0.904|
71758102|NCT02683577|143018573|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.462|||||TWO_SIDED|90.0|1.579|3.837|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.||3.837|1.579|
71758103|NCT02683577|143018574|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the mild HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
71758104|NCT02683577|143018574|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|1|TWO_SIDED|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the moderate HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||0.000|0.000|=1.0000
71790016|NCT01313767|143077742|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1164||||0.1176|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1176
71838269|NCT04064164|143183786|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App. Significant associations indicated the human and app were accurately identifying true positives (1:1) or true negatives (0:0).|||||<|0.001||||||Sweet (root word)|Chi-squared|X-squared = 20.20 df=1||||||<.001
71671980|NCT03982511|142862216|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T2 to T1|effect size: -0.06|||0.91
71758105|NCT02683577|143018575|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.294|||||TWO_SIDED|90.0|1.144|4.598|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for AUC(0-tlast) values for telotristat ethyl.||4.598|1.144|
71758106|NCT02683577|143018575|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.168|||||TWO_SIDED|90.0|1.715|5.852|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for telotristat ethyl.||5.852|1.715|
71758107|NCT02683577|143018577|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|1.72|||||TWO_SIDED|90.0|1.11|2.65|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for LP-778902.||2.65|1.11|
71790017|NCT01313767|143077742|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1138||||0.1252|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.||||0.1252
71838270|NCT04064164|143183786|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.02||||||Girl (root word)|Chi-squared|X-squared = 5.08, df=1||||||.02
71838271|NCT04064164|143183786|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.1||||||Honey (root word)|Chi-squared|X-squared = 2.7, df= 1||||||.10
71838272|NCT04064164|143183786|EQUIVALENCE|Pearson's Chi-square test was completed between the total instances of diminutives either identified by human or the Elderspeak App.||||||0.85||||||Baby (root word)|Chi-squared|X-squared = 12.2, df = 1||||||0.85
71838273|NCT04059484|143183787|SUPERIORITY||Hazard Ratio (HR)|1.051||||0.6437|TWO_SIDED|95.0|0.789|1.4||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of visceral metastasis, prior treatment with CDK4/6 inhibitors and ECOG according to IRT.|Amcenestrant versus PCEM|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures was reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.4|0.789|0.6437
71838274|NCT01987895|143183895|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-1.4|||||TWO_SIDED|95.0|-7.2|4.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||4.3|-7.2|
71838275|NCT01987895|143183895|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-2.4|||||TWO_SIDED|95.0|-8.1|3.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||3.2|-8.1|
71838276|NCT01987895|143183896|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.|Difference between 2 proportions|-4.1|||||TWO_SIDED|95.0|-9.2|1.0|||||CI for the difference between two proportions are estimated using the Wilson' score method|||1.0|-9.2|
71838277|NCT01987895|143183897|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|3.3|||||TWO_SIDED|95.0|-4.3|10.8|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.8|-4.3|
71671981|NCT03982511|142862216|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.22||0.45|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for emotional feeding scores from T3 to T1|effect size: -0.40|||0.45
71671982|NCT03982511|142862217|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T2 to T1.|effect size: -1.12|||0.03
71671983|NCT03982511|142862217|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for instrumental feeding scores from T3 to T1|effect size: -1.25|||0.03
71838278|NCT01987895|143183898|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6016|TWO_SIDED|95.0|0.8|1.14||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.14|0.80|0.6016
71838279|NCT01987895|143183899|SUPERIORITY||Least Square Mean difference|0.002||||0.9814|TWO_SIDED|95.0|-0.2|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.20|-0.20|0.9814
71838280|NCT01987895|143183899|SUPERIORITY||Least Square Mean difference|0.087||||0.2879|TWO_SIDED|95.0|-0.07|0.25||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.25|-0.07|0.2879
71838281|NCT01987895|143183899|SUPERIORITY||Least Square Mean difference|0.05||||0.488|TWO_SIDED|95.0|-0.09|0.19||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the systemic / other symptoms domain scores||0.19|-0.09|0.4880
71838282|NCT01987895|143183900|OTHER||Difference between 2 proportions|-1.8|||||TWO_SIDED|95.0|-6.5|2.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.9|-6.5|
71838283|NCT01987895|143183901|OTHER||Difference between 2 proportions|-1.9|||||TWO_SIDED|95.0|-6.2|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||2.3|-6.2|
71838284|NCT01987895|143183902|OTHER||Difference between 2 proportions|3.7|||||TWO_SIDED|95.0|-3.4|10.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||10.7|-3.4|
71838285|NCT01987895|143183903|OTHER|Sensitivity analysis|Difference between 2 proportions|1.1|||||TWO_SIDED|95.0|-6.5|8.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|||8.7|-6.5|
71838286|NCT05256017|143183905|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||||3.7|-7.2|
71838287|NCT05256017|143183906|OTHER||Excess rate (ER)|-0.9|||||TWO_SIDED|95.0|-4.1|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|Occurrence and excess rate (95% CI) of any TEAEs (by PT, for PTs reported in ≥1% of participants in either arm) from the investigational product administration (Day 1) to the Month 4 follow-up visit.||1.4|-4.1|
71671984|NCT03982511|142862218|SUPERIORITY||Mean Difference (Net)|2.23|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation from T2 to T1|effect size: 1.02|||0.05
71838288|NCT05256017|143183907|OTHER||Excess rate (ER)|0.4|||||TWO_SIDED|95.0|-1.6|1.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.6|-1.6|
71671985|NCT03982511|142862218|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|1.47||0.11|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for active mediation scores from T3 to T1|effect size: 0.88|||0.11
71671986|NCT03982511|142862219|SUPERIORITY||Mean Difference (Net)|3.64|STANDARD_ERROR_OF_MEAN|1.0||0.002|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T2 to T1|effect size: 1.77|||0.002
71758108|NCT02683577|143018577|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.0|||||TWO_SIDED|90.0|1.51|2.66|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on Cmax values for LP-778902.||2.66|1.51|
71758109|NCT02683577|143018578|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.316|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.3160
71790018|NCT01313767|143077743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.098||||0.3431|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.||||0.3431
71790019|NCT01313767|143077743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1097||||0.1329|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test||||0.1329
71790020|NCT01313767|143077743|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0853||||0.2611|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test||||0.2611
71790021|NCT01313767|143077744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0654||||0.4623|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.4623
71671987|NCT03982511|142862219|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.08||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for restrictive mediation scores from T3 to T1|effect size: 0.63|||0.24
71671988|NCT03982511|142862220|SUPERIORITY||Mean Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|1.05||0.53|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T2 to T1|effect size: 0.31|||0.53
71671989|NCT03982511|142862220|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for social coviewing from T3 to T1|effect size: 0.15|||0.77
71790022|NCT01313767|143077744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1194||||0.2007|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.2007
71790023|NCT01313767|143077744|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0172||||0.8553|TWO_SIDED||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.||||0.8553
71790024|NCT01313767|143077745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.6040
71790025|NCT01313767|143077745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.3233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.3233
71790026|NCT01313767|143077745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.4469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.||||0.4469
71790027|NCT01313767|143077746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1220
71790028|NCT01313767|143077746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.1016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.1016
71838289|NCT05256017|143183908|OTHER||Excess rate (ER)|-0.5|||||TWO_SIDED|95.0|-3.2|1.4|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.4|-3.2|
71838290|NCT05256017|143183909|OTHER||Excess rate (ER)|-0.6|||||TWO_SIDED|95.0|-2.6|0.6|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.6|-2.6|
71671990|NCT03982511|142862221|SUPERIORITY||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.23||0.91|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T2 to T1|effect size: 0.04|||0.91
71790029|NCT01313767|143077746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32||||0.2235|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.||||0.2235
71790030|NCT01313767|143077747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.503|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.5030
71790031|NCT01313767|143077747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.6934|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.6934
71790032|NCT01313767|143077747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9574|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.||||0.9574
71790033|NCT01313767|143077748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
71758110|NCT02683577|143018578|SUPERIORITY_OR_OTHER||Median difference|0.0|||=|0.4671|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.||1.000|0.000|=0.4671
71758111|NCT02683577|143018579|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.39|||||TWO_SIDED|90.0|1.45|3.94|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||3.94|1.45|
71790034|NCT01313767|143077748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.7237|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.||||0.7237
71790035|NCT01313767|143077748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.4017|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.||||0.4017
71790036|NCT01313767|143077749|SUPERIORITY_OR_OTHER|||||||0.2346|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.2346
71790037|NCT01313767|143077750|SUPERIORITY_OR_OTHER|||||||0.9513|TWO_SIDED||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.||||0.9513
71790038|NCT01313767|143077751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.8088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.8088
71790039|NCT01313767|143077751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.3702|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.3702
71758112|NCT02683577|143018579|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.52|||||TWO_SIDED|90.0|2.45|5.03|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.||5.03|2.45|
71790040|NCT01313767|143077751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.1497|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.||||0.1497
71790041|NCT01313767|143077752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.9634|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.9634
71790042|NCT01313767|143077752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.7302|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7302
71790043|NCT01313767|143077752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.7715|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.||||0.7715
71790044|NCT01313767|143077753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9362|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.9362
71790045|NCT01313767|143077753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.7998|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.7998
71790046|NCT01313767|143077753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5436|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.||||0.5436
71790047|NCT01313767|143077754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.7014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.7014
71790048|NCT01313767|143077754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8884|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.8884
71758113|NCT02683577|143018580|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|2.26|||||TWO_SIDED|90.0|1.33|3.82|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on ln transformed AUC(0-inf) values for LP-778902.||3.82|1.33|
71758114|NCT02683577|143018580|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|3.32|||||TWO_SIDED|90.0|2.3|4.8|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-inf) values for LP-778902.||4.80|2.30|
71758115|NCT05571605|143018595|OTHER|||||||0.05|||||||ANOVA|||||||0.05
71758116|NCT02158546|143018621|SUPERIORITY||Least square means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.782|TWO_SIDED|95.0|-2.1|1.6|||Mixed Models Analysis|||||1.6|-2.1|0.782
71758117|NCT02900378|143018625|OTHER||Differences of least square means|5.68|STANDARD_ERROR_OF_MEAN|4.89||0.2464|TWO_SIDED|95.0|-3.93|15.29||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS)||15.29|-3.93|0.2464
71758118|NCT02900378|143018625|OTHER||Differences of least square means|8.98|STANDARD_ERROR_OF_MEAN|4.58||0.0503|TWO_SIDED|97.5|-1.31|19.27||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without AE/SAE)||19.27|-1.31|0.0503
71790049|NCT01313767|143077754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.284|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.||||0.2840
71790050|NCT01287897|143077779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|10.5||0.3406|TWO_SIDED|90.0|-13.0|21.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|Generalized linear mixed model (GLMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||21.7|-13.0|0.3406
71790051|NCT01287897|143077779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.7|STANDARD_ERROR_OF_MEAN|11.0||0.0438|TWO_SIDED|90.0|0.7|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.7|0.0438
71790052|NCT01287897|143077780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2|STANDARD_ERROR_OF_MEAN|13.6||0.2258|TWO_SIDED|90.0|-12.1|32.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||32.6|-12.1|0.2258
71790053|NCT01287897|143077781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|10.5||0.2627|TWO_SIDED|90.0|-10.6|23.9||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||23.9|-10.6|0.2627
71758119|NCT02900378|143018626|OTHER||Differences of least square means|-6.14|STANDARD_ERROR_OF_MEAN|8.61||0.4769|TWO_SIDED|97.5|-25.7|13.41||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with MI)||13.41|-25.70|0.4769
71758120|NCT02900378|143018626|OTHER||Differences of least square means|-5.67|STANDARD_ERROR_OF_MEAN|6.01||0.3463|TWO_SIDED|95.0|-17.48|6.14||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with LOCF)||6.14|-17.48|0.3463
71758121|NCT02900378|143018626|OTHER||Differences of least square means|-6.24|STANDARD_ERROR_OF_MEAN|6.69||0.3513|TWO_SIDED|95.0|-19.39|6.91||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without MI/LOCF)||6.91|-19.39|0.3513
71758122|NCT02900378|143018627|OTHER||Odds Ratio (OR)|1.228|||||TWO_SIDED|95.0|0.882|1.708||||||FAS population||1.708|0.882|
71758123|NCT02900378|143018628|OTHER||Odds Ratio (OR)|1.251|||||TWO_SIDED|95.0|0.895|1.748||||||FAS subset without AE/SAE||1.748|0.895|
71758124|NCT02900378|143018629|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.634|2.464||||||FAS population||2.464|0.634|
71758125|NCT02900378|143018630|OTHER||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.644|2.544||||||FAS subset without AE/SAE||2.544|0.644|
71758126|NCT02900378|143018631|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.863|1.811||||||FAS population||1.811|0.863|
71758127|NCT02900378|143018632|OTHER||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.865|1.834||||||FAS subset without AE/SAE||1.834|0.865|
71758128|NCT02900378|143018633|OTHER|||||||0.1814|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS)||||0.1814
71758129|NCT02900378|143018633|OTHER|||||||0.3315|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS without AE/SAE)||||0.3315
71758130|NCT02900378|143018633|OTHER|||||||0.2414|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS)||||0.2414
71758131|NCT02900378|143018633|OTHER|||||||0.1793|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS without AE/SAE)||||0.1793
71758132|NCT02900378|143018634|OTHER||Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.462|1.457||||||Increased levels (\>= 10% increase) of non sedentary daytime physical activity at Week 12||1.457|0.462|
71758133|NCT02900378|143018635|OTHER|||||||0.0516|||||||Chi-squared|||Week 4||||0.0516
71790054|NCT01287897|143077781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.8|STANDARD_ERROR_OF_MEAN|10.9||0.0425|TWO_SIDED|90.0|0.8|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||36.7|0.8|0.0425
71838291|NCT05256017|143183910|OTHER||Excess rate (ER)|-0.2|||||TWO_SIDED|95.0|-2.2|0.8|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.8|-2.2|
71838292|NCT05256017|143183911|OTHER||Excess rate (ER)|-0.3|||||TWO_SIDED|95.0|-2.3|0.7|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.7|-2.3|
71671991|NCT03982511|142862221|SUPERIORITY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|1.36||0.64|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in the home from T3 to T1|effect size: 0.17|||0.64
71671992|NCT03982511|142862221|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.34||0.31|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T2 to T1|effect size: -0.36|||0.31
71758134|NCT02900378|143018635|OTHER|||||||0.9025|||||||Chi-squared|||Week 8||||0.9025
71758135|NCT02900378|143018635|OTHER|||||||0.6713|||||||Chi-squared|||Week 12||||0.6713
71758136|NCT02900378|143018636|OTHER|||||||0.0029|||||||Chi-squared|||Week 4||||0.0029
71758137|NCT02900378|143018636|OTHER|||||||0.7754|||||||Chi-squared|||Week 8||||0.7754
71758138|NCT02900378|143018636|OTHER|||||||0.2172|||||||Chi-squared|||Week 12||||0.2172
71758139|NCT02900378|143018637|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0008
71758140|NCT02900378|143018637|OTHER|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0008
71758141|NCT02900378|143018637|OTHER|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0297
71838293|NCT05256017|143183912|OTHER||Excess rate (ER)|3.2|||||TWO_SIDED|95.0|0.3|5.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||5.3|0.3|
71758142|NCT02900378|143018637|OTHER|||||||0.0069|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0069
71758143|NCT02900378|143018637|OTHER|||||||0.2275|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.2275
71758144|NCT02900378|143018637|OTHER|||||||0.3486|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.3486
71758145|NCT02900378|143018637|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.6800
71758146|NCT02900378|143018637|OTHER|||||||0.7184|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.7184
71758147|NCT02900378|143018637|OTHER|||||||0.5301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5301
71758148|NCT02900378|143018637|OTHER|||||||0.6019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.6019
71758149|NCT02900378|143018637|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8229
71758150|NCT02900378|143018637|OTHER|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.8229
71758151|NCT02900378|143018638|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0001
71758152|NCT02900378|143018638|OTHER|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0123
71758153|NCT02900378|143018638|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.2560
71758154|NCT02900378|143018638|OTHER|||||||0.5865|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.5865
71758155|NCT02900378|143018638|OTHER|||||||0.5463|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.5463
71758156|NCT02900378|143018638|OTHER|||||||0.3212|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.3212
71758157|NCT02900378|143018639|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0004
71758158|NCT02900378|143018639|OTHER|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0009
71758159|NCT02900378|143018639|OTHER|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0094
71758160|NCT02900378|143018639|OTHER|||||||0.0301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0301
71758161|NCT02900378|143018639|OTHER|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.1557
71758162|NCT02900378|143018639|OTHER|||||||0.6461|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6461
71758163|NCT02900378|143018639|OTHER|||||||0.9759|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.9759
71758164|NCT02900378|143018639|OTHER|||||||0.3941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3941
71758165|NCT02900378|143018639|OTHER|||||||0.7209|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.7209
71758166|NCT02900378|143018639|OTHER|||||||0.4444|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4444
71758167|NCT02900378|143018639|OTHER|||||||0.7247|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.7247
71758168|NCT02900378|143018639|OTHER|||||||0.2933|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.2933
71758169|NCT02900378|143018640|OTHER|||||||0.0854|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0854
71758170|NCT02900378|143018640|OTHER|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0528
71758171|NCT02900378|143018640|OTHER|||||||0.4137|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.4137
71758172|NCT02900378|143018640|OTHER|||||||0.0082|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0082
71758173|NCT02900378|143018640|OTHER|||||||0.7908|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.7908
71758174|NCT02900378|143018640|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.6499
71758175|NCT02900378|143018640|OTHER|||||||0.5547|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.5547
71758176|NCT02900378|143018640|OTHER|||||||0.6961|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.6961
71758177|NCT02900378|143018640|OTHER|||||||0.5946|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5946
71758178|NCT02900378|143018640|OTHER|||||||0.8957|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.8957
71758179|NCT02900378|143018640|OTHER|||||||0.8468|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.8468
71758180|NCT02900378|143018640|OTHER|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1711
71758181|NCT02900378|143018641|OTHER|||||||0.0065|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0065
71758182|NCT02900378|143018641|OTHER|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0316
71758183|NCT02900378|143018641|OTHER|||||||0.1342|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.1342
71838294|NCT05256017|143183913|OTHER||Excess rate (ER)|-0.1|||||TWO_SIDED|95.0|-2.4|1.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||1.3|-2.4|
71838295|NCT05256017|143183914|OTHER||Excess rate (ER)|-1.1|||||TWO_SIDED|95.0|-3.5|0.3|||||"ER: calculated as occurrence rate of the TEAE in the acoziborole arm minus occurrence rate of the TEAE in the placebo arm.~CI: calculated using the Wilson score interval."|||0.3|-3.5|
71838296|NCT05256017|143183915|OTHER||Excess rate (ER)|1.0|||||TWO_SIDED|95.0|-3.7|5.1||||||Occurrence and excess rate (95% CI) of any TEAEs reported during hospitalization.||5.1|-3.7|
71838297|NCT05256017|143183915|OTHER||Excess rate (ER)|-3.3|||||TWO_SIDED|95.0|-8.2|0.9||||||Occurrence and excess rate (95% CI) of any TEAEs reported after the hospitalization period.||0.9|-8.2|
71758184|NCT02900378|143018641|OTHER|||||||0.0252|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0252
71838298|NCT05256017|143183916|OTHER||Excess rate (ER)|-1.0|||||TWO_SIDED|95.0|-3.1|0.0||||||||0.0|-3.1|
71758185|NCT02900378|143018641|OTHER|||||||0.9024|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.9024
71758186|NCT02900378|143018641|OTHER|||||||0.9052|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.9052
71758187|NCT02900378|143018641|OTHER|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2870
71758188|NCT02900378|143018641|OTHER|||||||0.3174|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3174
71758189|NCT02900378|143018641|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5020
71758190|NCT02900378|143018641|OTHER|||||||0.4037|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4037
71758191|NCT02900378|143018641|OTHER|||||||0.4823|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4823
71758192|NCT02900378|143018641|OTHER|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1090
71758193|NCT02900378|143018642|OTHER|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.0061
71758194|NCT02900378|143018642|OTHER|||||||0.0143|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.0143
71758195|NCT02900378|143018642|OTHER|||||||0.0708|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.0708
71758196|NCT02900378|143018642|OTHER|||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0750
71758197|NCT02900378|143018642|OTHER|||||||0.8017|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.8017
71758198|NCT02900378|143018642|OTHER|||||||0.7956|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.7956
71758199|NCT02900378|143018642|OTHER|||||||0.3499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.3499
71758200|NCT02900378|143018642|OTHER|||||||0.1192|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.1192
71758201|NCT02900378|143018642|OTHER|||||||0.5237|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5237
71758202|NCT02900378|143018642|OTHER|||||||0.3902|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.3902
71758203|NCT02900378|143018642|OTHER|||||||0.4228|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.4228
71758204|NCT02900378|143018642|OTHER|||||||0.1571|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.1571
71758205|NCT02900378|143018643|OTHER|||||||0.3231|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1||||0.3231
71758206|NCT02900378|143018643|OTHER|||||||0.3519|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.3519
71758207|NCT02900378|143018643|OTHER|||||||0.8335|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3||||0.8335
71758208|NCT02900378|143018643|OTHER|||||||0.0465|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0465
71758209|NCT02900378|143018643|OTHER|||||||0.5016|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5||||0.5016
71758210|NCT02900378|143018643|OTHER|||||||0.5941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.5941
71758211|NCT02900378|143018643|OTHER|||||||0.2019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7||||0.2019
71838299|NCT05256017|143183917|OTHER||Excess rate (ER)|-1.5|||||TWO_SIDED|95.0|-7.2|3.7||||||Of note, all AEs reported during this study were TEAEs.||3.7|-7.2|
71838300|NCT05256017|143183935|OTHER||Placebo-corrected change from baseline|-0.4|||||TWO_SIDED|90.0|-2.1|1.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.4|-2.1|
71838301|NCT05256017|143183936|OTHER||Placebo-corrected change from baseline|-0.5|||||TWO_SIDED|90.0|-22.0|21.1||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||21.1|-22.0|
71838302|NCT05256017|143183937|OTHER||Placebo-corrected change from baseline|-1.1|||||TWO_SIDED|90.0|-3.6|1.3||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||1.3|-3.6|
71838303|NCT05256017|143183938|OTHER||Placebo-corrected change from baseline|-0.7|||||TWO_SIDED|90.0|-1.9|0.4||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||0.4|-1.9|
71838304|NCT05256017|143183939|OTHER||Placebo-corrected change from baseline|-10.9|||||TWO_SIDED|90.0|-15.3|-6.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-6.6|-15.3|
71838305|NCT05256017|143183940|OTHER||Placebo-corrected change from baseline|-11.5|||||TWO_SIDED|90.0|-14.4|-8.7||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.7|-14.4|
71838306|NCT05256017|143183941|OTHER||Placebo-corrected change from baseline|-11.7|||||TWO_SIDED|90.0|-14.9|-8.6||||||Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.||-8.6|-14.9|
71838307|NCT05256017|143183942|OTHER||Estimate|-10.7|STANDARD_DEVIATION|1.72|||TWO_SIDED|90.0|-13.5|-7.85||||||Estimated ΔΔQTcF (in ms) computed from a concentration-response (C-R) model between dry blood spot concentration of acoziborole and changes from baseline in QTcF parameter||-7.85|-13.5|
71838308|NCT04788511|143184042|SUPERIORITY||Estimated Treatment Difference|7.8|||<|0.0001|TWO_SIDED|95.0|4.8|10.9|||ANCOVA|||The responses at week 52 were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline KCCQ-CSS as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||10.9|4.8|<0.0001
71671993|NCT03982511|142862221|SUPERIORITY||Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|0.39||0.04|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for number of screens in child bedroom from T3 to T1|effect size: -0.85|||0.04
71671994|NCT03982511|142862222|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.03|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T2 to T1|effect size: -1.25|||0.03
71671995|NCT03982511|142862222|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.1|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided|ANOVA|repeated measures||Difference on difference for TV on during mealtime from T3 to T1|effect size: -1.08|||0.10
71671996|NCT03982511|142862222|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.41|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T2 to T1|effect size: -0.44|||0.41
71671997|NCT03982511|142862222|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.21|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mobile device present during mealtime from T3 to T1|effect size: -0.80|||0.21
71671998|NCT03982511|142862222|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T2 to T1|effect size: -1.29|||0.02
71758212|NCT02900378|143018643|OTHER|||||||0.4125|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.4125
71838309|NCT04788511|143184043|SUPERIORITY||Estimated Treatment Difference|-10.7|||<|0.0001|TWO_SIDED|95.0|-11.9|-9.4|||ANCOVA|||The responses were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\<35.0 kg/m\^2, BMI\>=35.0 kg/m\^2) as factors and baseline body weight (kg) as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.||-9.4|-11.9|<0.0001
71758213|NCT02900378|143018643|OTHER|||||||0.5702|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9||||0.5702
71758214|NCT02900378|143018643|OTHER|||||||0.4752|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10||||0.4752
71892494|NCT01381094|143306465|SUPERIORITY||||||=|0.1306|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1306
71671999|NCT03982511|142862222|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.2|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for other media present during mealtime from T3 to T1|effect size: -0.82|||0.20
71672000|NCT03982511|142862223|SUPERIORITY||Mean Difference (Net)|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.009|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T2 to T1|effect size: 1.55|||0.009
71758215|NCT02900378|143018643|OTHER|||||||0.5343|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11||||0.5343
71758216|NCT02900378|143018643|OTHER|||||||0.0985|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.0985
71758217|NCT02900378|143018644|OTHER|||||||0.4525|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2||||0.4525
71758218|NCT02900378|143018644|OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4||||0.0445
71758219|NCT02900378|143018644|OTHER|||||||0.1158|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6||||0.1158
71758220|NCT02900378|143018644|OTHER|||||||0.3901|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8||||0.3901
71758221|NCT02900378|143018644|OTHER|||||||0.7725|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12||||0.7725
71758222|NCT03060096|143018676|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71758223|NCT03060096|143018677|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71758224|NCT03060096|143018678|OTHER||Rate|0.764|||||ONE_SIDED|95.0|0.6783||||||||||0.6783|
71758225|NCT00346697|143018696|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71758226|NCT00346697|143018697|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||.80
71758227|NCT00346697|143018698|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71758228|NCT00346697|143018699|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71758229|NCT00346697|143018700|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71758230|NCT00346697|143018701|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
71758231|NCT00346697|143018702|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
71758232|NCT00346697|143018703|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71758233|NCT00346697|143018704|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71758234|NCT00346697|143018705|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71758235|NCT00346697|143018706|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71892495|NCT01381094|143306465|SUPERIORITY||||||=|0.9889|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.9889
71672001|NCT03982511|142862223|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime task accomplishment scores from T3 to T1|effect size: -0.13|||0.84
71672002|NCT03982511|142862223|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.2||0.24|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T2 to T1|effect size: 0.63|||0.24
71758236|NCT00346697|143018707|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71758237|NCT00346697|143018708|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71758238|NCT00346697|143018709|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71758239|NCT00346697|143018710|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
71758240|NCT03326713|143018718|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.0001|TWO_SIDED|95.0|2.5|15.2|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (TP vs TCN)||15.2|2.5|<.0001
71758241|NCT03326713|143018718|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.0001|TWO_SIDED|95.0|2.8|19.4|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TCN)||19.4|2.8|<.0001
71758242|NCT03326713|143018718|SUPERIORITY||Odds Ratio (OR)|1.2||||1.2|TWO_SIDED|95.0|0.4|4.0|||Regression, Logistic|||Logistic Regression Model Results for Intervention Effects on CGRA Within 6 Months (UC vs TP)||4.0|0.4|1.2
71758243|NCT01198977|143018755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.013||||||Baseline and 3-month follow-up for arm 1 and arm 2.|ANOVA|||||||.013
71892496|NCT01381094|143306465|SUPERIORITY||||||=|0.2026|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.2026
71758244|NCT01198977|143018755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.005||||||Comparing baseline to 6-month follow-up.|ANOVA|||||||0.005
71758245|NCT01198977|143018755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.01||||||The interaction effect between the two conditions across time. Baseline, 3-month, 6-month.|ANOVA|||||||0.010
71758246|NCT01198977|143018756|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.009||||||Comparing depression scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||0.009
71758247|NCT01198977|143018756|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.032||||||Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months).|ANOVA|||||||.032
71758248|NCT01198977|143018757|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.049||||||Physical Activity Interaction effect between the Telephone Counseling and Education Counseling Group over time (baseline, 3 months, 6 months).|ANOVA|||||||0.049
71790055|NCT01287897|143077782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|STANDARD_ERROR_OF_MEAN|13.7||0.1362|TWO_SIDED|90.0|-7.5|37.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||||37.6|-7.5|0.1362
71672003|NCT03982511|142862223|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.15||0.84|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for mealtime behavior control scores from T3 to T1.|effect size: -0.13|||0.84
71892497|NCT01381094|143306465|SUPERIORITY||||||=|0.5703|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.5703
71838310|NCT03637660|143184057|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.002|TWO_SIDED|90.0|-0.15|0.03||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|To assess the primary efficacy endpoint, the number and proportion of participants with a serological response by Month 6 and the 95% confidence interval were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis for the primary objective was that the difference in proportion of participants with serological responses between the three-dose and one-dose groups was at least 10%||0.03|-0.15|0.002
71838311|NCT03637660|143184065|EQUIVALENCE|The alternative hypothesis was that the two treatment groups were unequal.|||||<|0.001||||||P-value was calculated based on 2-sided Pearson Chi-Square test. Difference in proportion was reported with the Wilson 95% CI|Chi-squared|||The number and proportion of participants who were compliant to the treatment, receiving all assigned doses within the assigned visit windows. The null hypothesis was no difference between two treatment groups.||||< 0.001
71838312|NCT03637660|143184067|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.022|TWO_SIDED|90.0|-0.17|0.07||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.07|-0.17|0.022
71838313|NCT03637660|143184067|NON_INFERIORITY|The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.037|TWO_SIDED|90.0|-0.22|0.09||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning|||The number and proportion of participants with serological response by month 6 among participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.09|-0.22|0.037
71838314|NCT03637660|143184068|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.05||||0.002|TWO_SIDED|90.0|-0.14|0.04||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by Month 12 and the 95% confidence interval (CI) were summarized overall and by treatment. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.04|-0.14|0.002
71838315|NCT03637660|143184069|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.06||||0.011|TWO_SIDED|90.0|-0.18|0.05||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) in HIV-infected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-infected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 among participants with HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.05|-0.18|0.011
71845588|NCT04941482|143205826|SUPERIORITY||Median Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|1.3|<|0.05|TWO_SIDED|95.0|-1.9|3.2||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Patient Health Questionnaire-9 score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.2|-1.9|<0.05
71672004|NCT03982511|142862224|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|2.17||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T2 to T1|effect size: -1.50|||0.00
71672005|NCT03982511|142862224|SUPERIORITY||Mean Difference (Net)|-7.63|STANDARD_ERROR_OF_MEAN|2.48||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for ECBI intensity t-scores from T3 to T1|effect size: -1.12|||0.01
71672006|NCT03982511|142862225|SUPERIORITY||Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.63||0.02|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T2 to T1|effect size: -0.93|||0.02
71672007|NCT03982511|142862225|SUPERIORITY||Mean Difference (Net)|-6.58|STANDARD_ERROR_OF_MEAN|3.56||0.08|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for internalizing symptoms from T3 to T1|effect size: -0.68|||0.08
71672008|NCT03982511|142862225|SUPERIORITY||Mean Difference (Net)|-6.47|STANDARD_ERROR_OF_MEAN|6.92||0.36|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for adaptive skills from T2 to T1|effect size: -0.33|||0.36
71672009|NCT03982511|142862225|SUPERIORITY||Mean Difference (Net)|-3.57|STANDARD_ERROR_OF_MEAN|8.83||0.69|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|Repeated measures||Difference on difference for adaptive skills from T3 to T1|effect size: -0.15|||0.69
71672010|NCT03982511|142862226|SUPERIORITY||Mean Difference (Net)|35.78|STANDARD_ERROR_OF_MEAN|7.21||0|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T2 to T1 (higher scores indicate better outcomes).|effect size: 1.70|||0.000
71672011|NCT03982511|142862226|SUPERIORITY||Mean Difference (Net)|21.78|STANDARD_ERROR_OF_MEAN|7.64||0.01|TWO_SIDED|||||Given that this is a pilot RCT (with a small n), primary aim is to estimate effect sizes for a more fully-powered RCT. Both p value and effect size will be provided.|ANOVA|repeated measures||Difference on difference for PSICA intensity scores from T3 to T1|effect size: 1.04|||0.01
71672012|NCT03982511|142862227|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.73|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures|Effect size: 0.17|Difference on difference from T2 to T1 for BMI z-score||||.73
71672013|NCT03982511|142862227|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.18||0.98|TWO_SIDED|||||Given this is a pilot RCT, primary aim is to estimate effect size for a more fully-powered RCT. P-values will be provided in addition to effect size.|ANOVA|Repeated measures||Difference on difference for BMI z-scores from T3 to T1.|Effect size: -0.01|||.98
71892498|NCT01381094|143306466|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
71672014|NCT02535026|142862244|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||ER status association with age groups||||0.280
71672015|NCT02535026|142862245|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||ER status association with nuclear grade.||||<0.001
71672016|NCT02535026|142862246|SUPERIORITY_OR_OTHER||||||=|0.03|||||||Chi-squared|||ER status association with lymphovascular invasion.||||=0.03
71672017|NCT02535026|142862247|SUPERIORITY_OR_OTHER||||||=|0.004|||||||Chi-squared|||PR status association with age groups||||=0.004
71672018|NCT02535026|142862248|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||PR status association with nuclear grade.||||<0.001
71672019|NCT02535026|142862249|SUPERIORITY_OR_OTHER||||||=|0.025|||||||ANOVA|||PR status association with lymphovascular invasion.||||=0.025
71672020|NCT02535026|142862250|SUPERIORITY_OR_OTHER||||||=|0.056|||||||ANOVA|||HER2 status association with age groups.||||=0.056
71672021|NCT02535026|142862251|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||HER2 status association with nuclear grade.||||<0.001
71672022|NCT02535026|142862252|SUPERIORITY_OR_OTHER||||||=|0.129|||||||Chi-squared|||||||=0.129
71672023|NCT02535026|142862253|SUPERIORITY_OR_OTHER||||||=|0.003|||||||ANOVA|||Breast cancer phenotypes association with age groups.||||=0.003
71672024|NCT02535026|142862254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Breast cancer phenotypes association with nuclear grades.||||<0.001
71672025|NCT02535026|142862255|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||phenotypes of breast cancer association with lymphovascular invasion.||||=0.001
71672026|NCT02535026|142862256|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with ER status.||||<0.001
71672027|NCT02535026|142862257|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Phenotypes of breast cancer association with PR status.||||<0.001
71672028|NCT02535026|142862258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with HER2 status.||||<0.001
71672029|NCT00925704|142862277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.171||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.171
71672030|NCT00925704|142862277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.024
71672031|NCT00925704|142862278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.313||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||0.313
71672032|NCT00925704|142862278|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.||||< 0.001
71672033|NCT00925704|142862279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.039
71672034|NCT00925704|142862279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305||95.0|||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.||||0.305
71672035|NCT02996968|142862280|NON_INFERIORITY|"Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.~A sample size was calculated to be 74 patients in each arm based on the following:~* The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%~* The non-inferiority margin was set at 15%.~* The power was set at 80%"|Proportion Difference|0.002||||0.5|ONE_SIDED|95.0||0.095||2-sample test for equality of proportions with continuity correction|Two proportions Z-test|||||0.095||0.5
71672036|NCT00216125|142862281|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.883|TWO_SIDED|95.0|||||Log Rank|||||||0.883
71672037|NCT03207815|142862289|SUPERIORITY||Difference in Treatment Failure Rate|-30.1||||0.0064|TWO_SIDED|95.0|-56.2|-4.1||P-value was estimated from the Cochran-Mantel-Haenszel (CMH) test, adjusted for the stratification factors.|Cochran-Mantel-Haenszel|Participants with missing values on treatment failure status were analyzed as treatment failures using a nonresponder imputation (NRI) method.||||-4.1|-56.2|0.0064
71758249|NCT01198977|143018757|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.014||||||Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months.|ANOVA|||||||.014
71758250|NCT03397966|143018762|SUPERIORITY|||||||0.063||||||The investigators tested the effect of treatment (BNP vs. control) on the primary endpoint using mixed effects modeling, adjusting for treatment sequence, to assess the effect of treatment on each endpoint.|Mixed Models Analysis|||The primary endpoint is change in resting energy expenditure, calculated as final resting energy expenditure adjusted for baseline level, using linear regression. The null hypothesis is that there will be no significant effect of treatment on each endpoint. The investigators adhered to intention-to-treat principles. The test was performed with a significance level of 0.05.||||0.063
71758251|NCT03397966|143018763|SUPERIORITY|||||||0.07||||||Paired t-test.|t-test, 2 sided|||The null hypothesis is that there will be no significant effect of BNP on adipose gene expression of UCP1 compared with placebo. The alternative hypothesis is that UCP1 expression would be significantly higher after BNP treatment compared with placebo.||||0.07
71790056|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|STANDARD_ERROR_OF_MEAN|7.0||0.1527|TWO_SIDED|90.0|-4.3|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 2.||18.6|-4.3|0.1527
71790057|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|9.1||0.0235|TWO_SIDED|90.0|3.1|33.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 4.||33.2|3.1|0.0235
71790058|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|9.9||0.0792|TWO_SIDED|90.0|-2.3|30.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 6.||30.2|-2.3|0.0792
71790059|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|11.0||0.1909||90.0|-8.4|27.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 10.||27.6|-8.4|0.1909
71790060|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|6.8||0.1981|TWO_SIDED|90.0|-5.4|17.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 2.||17.0|-5.4|0.1981
71672038|NCT03207815|142862290|SUPERIORITY||Stratified Hazard Ratio|0.309||||0.0014|TWO_SIDED|95.0|0.144|0.663||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% confidence interval \[CI\]) were derived from the Cox model stratified by the stratification factors.|||0.663|0.144|0.0014
71672039|NCT03207815|142862291|SUPERIORITY||Least Squares Mean Treatment Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.355|TWO_SIDED|95.0|-0.4|0.2||P-value was estimated using a repeated measure Analysis of Covariance (ANCOVA) model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in Least Squares (LS)-means (95% CI) were obtained from the repeated measure ANCOVA model.|||0.2|-0.4|0.3550
71672040|NCT03207815|142862292|SUPERIORITY||LS Mean Treatment Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0145|TWO_SIDED|95.0|-0.8|-0.1||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.1|-0.8|0.0145
71672041|NCT03207815|142862293|SUPERIORITY||LS Mean Treatment Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0389|TWO_SIDED|95.0|-0.1|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, stratification factors and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.10|0.0389
71892499|NCT01381094|143306466|SUPERIORITY||||||=|0.0092|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0092
71677218|NCT04143594|142873012|SUPERIORITY||Difference in LSM|-22.0||||0.6169|TWO_SIDED|95.0|-111.0|67.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||67|-111|0.6169
71790061|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_ERROR_OF_MEAN|9.3||0.0132|TWO_SIDED|90.0|5.3|35.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 4.||35.8|5.3|0.0132
71790062|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|10.1||0.0063|TWO_SIDED|90.0|8.6|41.7|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 6.||41.7|8.6|0.0063
71790063|NCT01287897|143077783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|11.2||0.0138|TWO_SIDED|90.0|6.2|43.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 10.||43.1|6.2|0.0138
71790064|NCT01287897|143077784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|10.2||0.0662|TWO_SIDED|90.0|-1.4|32.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 2.||32.1|-1.4|0.0662
71790065|NCT01287897|143077784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|10.0||0.1708|TWO_SIDED|90.0|-6.9|25.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 4.||25.8|-6.9|0.1708
71790066|NCT01287897|143077784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|11.1||0.2416|TWO_SIDED|90.0|-10.5|26.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 6.||26.0|-10.5|0.2416
71790067|NCT01287897|143077784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.1|STANDARD_ERROR_OF_MEAN|14.1||0.088|TWO_SIDED|90.0|-4.1|42.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 10.||42.3|-4.1|0.0880
71790068|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|3.2||0.261|TWO_SIDED|90.0|-3.2|7.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 2.||7.2|-3.2|0.2610
71790069|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.8||0.4291|TWO_SIDED|90.0|-5.6|7.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 4.||7.0|-5.6|0.4291
71790070|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|6.0||0.5791|TWO_SIDED|90.0|-11.0|8.6|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 6.||8.6|-11.0|0.5791
71790071|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|8.0||0.7544|TWO_SIDED|90.0|-18.8|7.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 8.||7.7|-18.8|0.7544
71790072|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|9.2||0.2308||90.0|-8.3|21.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 10.||21.9|-8.3|0.2308
71790073|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|7.1||0.5038|TWO_SIDED|90.0|-11.8|11.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 12.||11.7|-11.8|0.5038
71790074|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|4.9||0.0498|TWO_SIDED|90.0|0.0|16.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 2.||16.0|0.0|0.0498
71790075|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.3|STANDARD_ERROR_OF_MEAN|7.6||0.0155|TWO_SIDED|90.0|3.9|28.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 4.||28.7|3.9|0.0155
71790076|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.5||0.0399|TWO_SIDED|90.0|0.9|28.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 6.||28.9|0.9|0.0399
71790077|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|9.6||0.1866|TWO_SIDED|90.0|-7.2|24.3|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 8.||24.3|-7.2|0.1866
71790078|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|10.3||0.0415|TWO_SIDED|90.0|0.9|34.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 10.||34.7|0.9|0.0415
71758252|NCT02864394|143018810|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1276|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||Treatment comparison (Hazard Ratio, HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. One-sided p-value was based on log-rank test.||1.14|0.61|0.1276
71758253|NCT02864394|143018811|OTHER||Hazard Ratio (HR)|0.75||||0.0076|TWO_SIDED|95.0|0.6|0.95|||Log Rank|||OS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||0.95|0.60|0.0076
71758254|NCT02864394|143018812|OTHER||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.54|1.07|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate. A nominal one-sided p-value for testing was based on log-rank test.||1.07|0.54|0.0534
71758255|NCT02864394|143018813|OTHER||Hazard Ratio (HR)|0.84||||0.0847|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||PFS was not formally tested. Treatment comparison (HR) based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%). A nominal one-sided p-value for testing was based on log-rank test stratified by PD-L1 expression status (TPS ≥50% vs. TPS 1-49%).||1.08|0.66|0.0847
71758256|NCT02864394|143018814|OTHER||Difference in Percentage|21.0|||<|0.0001|TWO_SIDED|95.0|11.5|30.7|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on the Miettinen \& Nurminen method. A nominal one-sided p-value for testing was calculated.||30.7|11.5|<0.0001
71758257|NCT02864394|143018815|OTHER||Difference in Percentage|15.0|||<|0.0001|TWO_SIDED|95.0|8.8|21.6|||Miettinen & Nurminen Method|||ORR was not formally tested. Treatment comparison was based on Miettinen \& Nurminen method stratified by PD-L1 expression status (TPS\>=50% vs. TPS 1-49%). If no participants were in one of the treatment arms involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison. A nominal one-sided p-value for testing was calculated.||21.6|8.8|<0.0001
71758258|NCT03762993|143018830|OTHER|Changes in phonation threshold pressure were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.001||||||P-value is for the effect of time. A priori significance level set at .05|Mixed Models Analysis|||||||<0.001
71758259|NCT03762993|143018831|OTHER|Changes in lung volumes were analyzed using a linear mixed effect model. Fixed factors included in the statistical model included time, group, and restoration strategy (controlled phonation or vocal rest). In addition, appropriate interactions were included and participant was added as a random factor in order to control for individual variation.|||||<|0.01||||||P-value represents effect of group. A priori threshold for significance set at .05|Mixed Models Analysis|||||||<0.01
71758260|NCT00790842|143018858|OTHER|Recommended Phase 2 dose for Group A|Dose in milligrams per day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day|Recommended Phase 2 dose for Group A||||
71790079|NCT01287897|143077785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.5|STANDARD_ERROR_OF_MEAN|9.5||0.0408|TWO_SIDED|90.0|0.9|32.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 12.||32.1|0.9|0.0408
71758261|NCT00790842|143018858|OTHER|Recommended phase 2 dose for patients in Group B|Dose in milligrams/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/minute who are not on dialysis|Recommended phase 2 dose for patients in Group B||||
71758262|NCT00790842|143018858|OTHER|Recommended phase 2 dose for Group C|Lenalidomide dose in mg/day|25.0|||||TWO_SIDED||||||||Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance \< 30 mL/min who are receiving dialysis|Recommended phase 2 dose for Group C||||
71758263|NCT05021978|143018867|OTHER|||||||0.1048||||||Change from baseline to Day 7 in TETRAS Upper Limb Score|Mixed Models Analysis|Includes timepoint as fixed effect and baseline TETRAS score as a covariate. Within subject variability modeled using unstructured covariance pattern.||Sample size is a convenience sample determined according to feasibility to provide sufficient and safety data to inform the development of future controlled studies with PRAX-944. In the open-label phase of the trial (Part A ), at least 10 participants would provide an 80% probability of observing at least 1 AE with an underlying incidence of 15% or greater and provide approximately 80% power to detect an effect size of 1.0 on the primary endpoint change from baseline in TETRAS Upper Limb score.||||0.1048
71758264|NCT05021978|143018867|OTHER|||||||0.0028||||||Change from baseline to Day 14 in TETRAS UL score|Mixed Models Analysis|||||||0.0028
71758265|NCT05021978|143018871|OTHER|||||||0.4025|||||||Mixed Models Analysis|Change from baseline to Day 7||||||0.4025
71758266|NCT05021978|143018871|OTHER|||||||0.0766||||||Change from baseline to Day 14|Mixed Models Analysis|||||||0.0766
71758267|NCT05021978|143018872|OTHER|||||||0.2501||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2501
71758268|NCT05021978|143018872|OTHER|||||||0.1874||||||Chnage from baseline to Day 14|Mixed Models Analysis|||||||0.1874
71758269|NCT05021978|143018873|OTHER|||||||0.4722||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.4722
71758270|NCT05021978|143018873|OTHER|||||||0.6215||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.6215
71758271|NCT05021978|143018873|OTHER|||||||0.9648||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9648
71758272|NCT05021978|143018873|OTHER|||||||0.2855||||||Item 7 Handwriting change from baseline to Day 14|Mixed Models Analysis|||||||0.2855
71758273|NCT05021978|143018873|OTHER|||||||0.205||||||Item 6 Archimedes Spiral (right) change from baseline to Day 14|Mixed Models Analysis|||||||0.2050
71790080|NCT01287897|143077786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|5.3||0.1342|TWO_SIDED|90.0|-2.8|14.5|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 2.||14.5|-2.8|0.1342
71758274|NCT05021978|143018873|OTHER|||||||0.2364||||||Item 6 Archimedes Spiral (left) change from baseline to Day 14|Mixed Models Analysis|||||||0.2364
71672042|NCT03207815|142862294|SUPERIORITY||LS Mean Treatment Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.011||0.034|TWO_SIDED|95.0|-0.05|0.0||P-value was estimated using a repeated measure ANCOVA model which included treatment, eye, interaction of treatment and eye, OCT machine, and best state value.|Repeated Measure ANCOVA|The repeated measure ANCOVA model was used to control for the clustered observations from each eye of a participant.|Treatment difference in LS-means (95% CI) were obtained from the repeated measure ANCOVA model.|||-0.00|-0.05|0.0340
71758275|NCT05021978|143018877|OTHER|||||||0.0216|||||||Mixed Models Analysis|||||||0.0216
71758276|NCT05021978|143018878|OTHER|||||||0.1042||||||Change from baseline Day 7|Mixed Models Analysis|||||||0.1042
71758277|NCT05021978|143018878|OTHER|||||||0.0257||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.0257
71758278|NCT05021978|143018879|OTHER|||||||0.2971||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.2971
71758279|NCT05021978|143018879|OTHER|||||||0.2034||||||Change from baseline Day 21|Mixed Models Analysis|||||||0.2034
71758280|NCT05021978|143018879|OTHER|||||||0.1105||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.1105
71790081|NCT01287897|143077786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|4.3||0.2623|TWO_SIDED|90.0|-4.3|9.8|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 4.||9.8|-4.3|0.2623
71672043|NCT03207815|142862295|SUPERIORITY||Stratified Hazard Ratio|1.193||||0.5893|TWO_SIDED|95.0|0.625|2.277||P-value was derived from the log rank test stratified by the stratification factors.|Stratified Log-Rank Test||Stratified hazard ratio (95% CI) were derived from the Cox model stratified by the stratification factors.|||2.277|0.625|0.5893
71758281|NCT05021978|143018880|OTHER|||||||0.005||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.0050
71790082|NCT01287897|143077786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|6.3||0.3324|TWO_SIDED|90.0|-7.7|13.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 6.||13.2|-7.7|0.3324
71758282|NCT05021978|143018880|OTHER|||||||0.0018||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0018
71758283|NCT05021978|143018880|OTHER|||||||0.0061||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0061
71758284|NCT05021978|143018881|OTHER|||||||0.9776||||||Item 6 Archimedes Spiral (right) change from baseline to Day 7|Mixed Models Analysis|||||||0.9776
71758285|NCT05021978|143018881|OTHER|||||||0.1962||||||Item 6 Archimedes Spiral (left) change from baseline to Day 7|Mixed Models Analysis|||||||0.1962
71758286|NCT05021978|143018881|OTHER|||||||0.9419||||||Item 7 Handwriting change from baseline to Day 7|Mixed Models Analysis|||||||0.9419
71758287|NCT05021978|143018881|OTHER|||||||0.0668||||||Item 6 Archimedes Spiral (right) change from baseline to Day 21|Mixed Models Analysis|||||||0.0668
71758288|NCT05021978|143018881|OTHER|||||||0.9191||||||Item 6 Archimedes Spiral (left) change from baseline to Day 21|Mixed Models Analysis|||||||0.9191
71758289|NCT05021978|143018881|OTHER|||||||0.6075||||||Item 7 Handwriting change from baseline to Day 21|Mixed Models Analysis|||||||0.6075
71758290|NCT05021978|143018881|OTHER|||||||0.246||||||Item 6 Archimedes Spiral (right) change from baseline to Day 42|Mixed Models Analysis|||||||0.2460
71758291|NCT05021978|143018881|OTHER|||||||0.6736||||||Item 6 Archimedes Spiral (left) change from baseline to Day 42|Mixed Models Analysis|||||||0.6736
71758292|NCT05021978|143018881|OTHER|||||||0.8511||||||Item 7 Handwriting change from baseline to Day 42|Mixed Models Analysis|||||||0.8511
71758293|NCT05021978|143018882|OTHER|||||||0.1505||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.1505
71758294|NCT05021978|143018882|OTHER|||||||0.0543||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0543
71758295|NCT05021978|143018882|OTHER|||||||0.0015||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0015
71758296|NCT05021978|143018883|OTHER|||||||0.8638||||||Change from baseline to Day 7|Mixed Models Analysis|||||||0.8638
71758297|NCT05021978|143018883|OTHER|||||||0.0605||||||Change from baseline to Day 21|Mixed Models Analysis|||||||0.0605
71758298|NCT05021978|143018883|OTHER|||||||0.0871||||||Change from baseline to Day 42|Mixed Models Analysis|||||||0.0871
71758299|NCT02177032|143018885|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-2.4|0.0|||Fisher Exact|||||0|-2.4|
71758300|NCT02177032|143018886|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667."|Vaccine Group Ratios|0.46|||||TWO_SIDED|95.0|0.37|0.58|||ANOVA|||||0.58|0.37|
71758301|NCT02177032|143018887|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)"|Vaccine Group Ratios|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANOVA|||||1.29|0.84|
71790083|NCT01287897|143077786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|7.5||0.6637|TWO_SIDED|90.0|-15.5|9.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 8.||9.1|-15.5|0.6637
71790084|NCT01287897|143077786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|STANDARD_ERROR_OF_MEAN|9.0||0.2721||90.0|-9.3|20.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 10.||20.2|-9.3|0.2721
71892500|NCT01381094|143306466|SUPERIORITY||||||=|0.0012|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.0012
71758302|NCT02177032|143018887|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)"|Vaccine Group Ratios|1.68|||||TWO_SIDED|95.0|1.35|2.1|||ANOVA|||||2.1|1.35|
71790085|NCT01287897|143077786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.8||0.3022|TWO_SIDED|90.0|-8.8|16.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 12.||16.9|-8.8|0.3022
71790086|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|7.0||0.2687|TWO_SIDED|90.0|-7.2|15.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 2.||15.8|-7.2|0.2687
71790087|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|7.4||0.246|TWO_SIDED|90.0|-7.1|17.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 4.||17.3|-7.1|0.2460
71790088|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.2|STANDARD_ERROR_OF_MEAN|9.3||0.0633|TWO_SIDED|90.0|-1.1|29.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 6.||29.5|-1.1|0.0633
71758303|NCT02177032|143018887|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91)."|Vaccine Group Ratios|0.68|||||TWO_SIDED|95.0|0.54|0.85|||ANOVA|||||0.85|0.54|
71758304|NCT02177032|143018887|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)"|Vaccine Group Ratios|1.22|||||TWO_SIDED|95.0|0.94|1.59|||ANOVA|||||1.59|0.94|
71758305|NCT02177032|143018887|NON_INFERIORITY_OR_EQUIVALENCE|"The investigational regimen 4-sites, 1-week ID PEP will be declared as non-inferior to currently recommended 2-sites TRC ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)"|Vaccine Group Ratios|1.67|||||TWO_SIDED|95.0|1.27|2.19|||ANOVA|||||2.19|1.27|
71758306|NCT02177032|143018888|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|9.0|||||TWO_SIDED|95.0|3.8|13.9|||Fisher Exact|||||13.9|3.8|
71790089|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|9.9||0.4036|TWO_SIDED|90.0|-13.8|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 8.||18.6|-13.8|0.4036
71758307|NCT02177032|143018888|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.6|||Fisher Exact|||||1.6|-1|
71758308|NCT02177032|143018888|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-3.0|||||TWO_SIDED|95.0|-6.0|-1.4|||Fisher Exact|||||-1.4|-6|
71790090|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|10.2||0.1921||90.0|-7.9|25.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 10.||25.6|-7.9|0.1921
71790091|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|10.3||0.1541|TWO_SIDED|90.0|-6.5|27.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 12.||27.5|-6.5|0.1541
71790092|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|6.5||0.4893|TWO_SIDED|90.0|-10.5|10.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 2.||10.9|-10.5|0.4893
71790093|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|8.6||0.0619|TWO_SIDED|90.0|-0.9|27.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 4.||27.4|-0.9|0.0619
71790094|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7|STANDARD_ERROR_OF_MEAN|9.3||0.029|TWO_SIDED|90.0|2.3|33.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 6.||33.1|2.3|0.0290
71790095|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|10.7||0.0988|TWO_SIDED|90.0|-3.8|31.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 8.||31.4|-3.8|0.0988
71838316|NCT03637660|143184069|NON_INFERIORITY|The alternative hypothesis was that the difference in response rates was less than 10%. The noninferiority margin is defined as 10%. It can be assessed by comparing the margin (10%) to the upper limit of the 2-sided 90% CI for the difference in proportions.|Difference of proportion of participants|-0.03||||0.064|TWO_SIDED|90.0|-0.18|0.11||P-value and 2-sided 90% CI are calculated based on the noninferiority analysis for the proportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|Farrington-Manning||The 2-sided 90% CI are calculated based on the noninferiority analysis for the -sproportion difference (one-dose group is non-inferior to three-dose group) among HIV-uninfected participants by Farrington-Manning method with a 10% margin.|The number and proportion of participants with a serological response by month 12 amont participants without HIV infection and the 95% confidence interval (CI) were summarized overall and by treatment status. The Farrington-Manning test at the 5% one-sided level of significance was used to test the noninferiority hypothesis. The null hypothesis was that the difference in serological response rate between the three-dose and one-dose groups was at least 10%.||0.11|-0.18|0.064
71838317|NCT05603143|143184087|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
71838318|NCT05603143|143184091|OTHER|||||||0.3219|||||||Log Rank|||||||0.3219
71838319|NCT05603143|143184092|OTHER||Hazard Ratio (HR)|1.496||||0.6568|TWO_SIDED|95.0|0.25|8.952|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||8.952|0.250|0.6568
71838320|NCT05603143|143184093|OTHER||Hazard Ratio (HR)|2.99||||0.319|TWO_SIDED|95.0|0.311|28.74|||Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression.|||28.740|0.311|0.3190
71838321|NCT05603143|143184094|OTHER|||||||0.3161|||||||Log Rank|||||||0.3161
71838322|NCT05603143|143184095|OTHER||Hazard Ratio (HR)|1.425||||0.0859|TWO_SIDED|95.0|0.961|2.112||P-value was based on stratified Log-rank test with randomization stratification factors as the strata.|Log Rank||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factors as covariates.|||2.112|0.961|0.0859
71838323|NCT05603143|143184096|OTHER||Treatment Difference (vs Placebo)|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||MMRM||Least-squares mean (SE), 95% CI and P value were from MMRM with baseline viral load and randomization strata as covariates.|||-0.33|-0.83|< 0.0001
71672044|NCT01671007|142862298|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.64|1.08|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.08|0.64|
71672045|NCT01671007|142862299|OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.7|1.27|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.27|0.70|
71838324|NCT05235750|143184202|OTHER||Mean Difference (Net)|0.2||||0.83|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for RSES.|We analyzed short- (at 6 weeks post-baseline or T3) and longer-term differences (at 8 weeks post-baseline or T4) for the RSES, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.83
71838325|NCT05235750|143184202|OTHER||Mean Difference (Net)|-0.2||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for RSES.|||||.91
71892501|NCT01381094|143306466|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||<0.0001
71758309|NCT02177032|143018888|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-1.0|||||TWO_SIDED|95.0|-4.5|3.2|||Fisher Exact|||||3.2|-4.5|
71838326|NCT05235750|143184203|OTHER||Mean Difference (Net)|-2.1||||0.45|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACT-G.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACT-G at scale, factor and item levels expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.45
71838327|NCT05235750|143184203|OTHER||Mean Difference (Net)|-3.3||||0.29|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACT-G.|||||.29
71838328|NCT05235750|143184203|OTHER||Mean Difference (Net)|0.8||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.46
71672046|NCT01671007|142862300|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.06|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.06|0.43|
71758310|NCT02177032|143018888|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen compared to the currently recommended 2-sites TRC (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|6.0|||||TWO_SIDED|95.0|1.3|11.5|||Fisher Exact|||||11.5|1.3|
71758311|NCT02177032|143018889|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-11.0|||||TWO_SIDED|95.0|-19.6|-1.0|||Fisher Exact|||||-1|-19.6|
71758312|NCT02177032|143018889|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|0.0|||||TWO_SIDED|95.0|-5.6|2.6|||Fisher Exact|||||2.6|-5.6|
71758313|NCT02177032|143018889|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-15.0|||||TWO_SIDED|95.0|-26.0|-7.1|||Fisher Exact|||||-7.1|-26|
71758314|NCT02177032|143018889|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-17.0|||||TWO_SIDED|95.0|-29.0|-7.1|||Fisher Exact|||||-7.1|-29|
71758315|NCT02177032|143018889|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority in immune response of the 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new 4-sites, 1-week (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is \> -0.05 (non-inferiority margin)."|Protection Rate Differences|-25.0|||||TWO_SIDED|95.0|-37.8|-13.2|||Fisher Exact|||||-13.2|-37.8|
71758316|NCT02558296|143018909|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the primary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.56|<0.0001
71758317|NCT02558296|143018910|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.4||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories, history of heart failure, treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.40|-0.65|<0.0001
71790096|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2|STANDARD_ERROR_OF_MEAN|10.8||0.0549|TWO_SIDED|90.0|-0.5|35.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 10.||35.0|-0.5|0.0549
71790097|NCT01287897|143077787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|10.5||0.092|TWO_SIDED|90.0|-3.3|31.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 12.||31.3|-3.3|0.0920
71790098|NCT01287897|143077788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|6.8||0.4031|TWO_SIDED|90.0|-9.5|12.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 2.||12.9|-9.5|0.4031
71790099|NCT01287897|143077788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|9.6||0.1219|TWO_SIDED|90.0|-4.6|26.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 4.||26.8|-4.6|0.1219
71790100|NCT01287897|143077788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|10.0||0.16|TWO_SIDED|90.0|-6.5|26.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 6.||26.4|-6.5|0.1600
71758318|NCT02558296|143018911|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in body weight from baseline to Week 48 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.07|-2.24||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c and eGFR, history of heart failure, insulin use (Y/N), treatment, visit and baseline body weight as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in body weight from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-2.24|-3.07|<0.0001
71892502|NCT01381094|143306466|SUPERIORITY||||||=|0.1157|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 2).||||=0.1157
71758319|NCT02558296|143018912|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in systolic blood pressure from baseline to Week 24 was less than the mean change in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Net)|-2.96||||0.0112|TWO_SIDED|95.0|-5.51|-0.42||P-value is presented based on one-sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline HbA1c, GFR categories, BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline SBP as fixed effect covariate.||The null hypothesis for the secondary endpoint was that the mean change in systolic blood pressure from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.42|-5.51|0.0112
71758320|NCT02558296|143018913|SUPERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.39||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.39|-0.50|<0.0001
71758321|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.49|-0.63|<0.0001
71758322|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
71790101|NCT01287897|143077788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.3||0.6019|TWO_SIDED|90.0|-19.5|14.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 8.||14.2|-19.5|0.6019
71790102|NCT01287897|143077788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|12.3||0.1601||90.0|-8.0|32.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 10.||32.5|-8.0|0.1601
71790103|NCT01287897|143077788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|11.7||0.2622|TWO_SIDED|90.0|-11.8|26.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 12.||26.6|-11.8|0.2622
71790104|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|12.22||0.2173|TWO_SIDED|90.0|-29.8|10.6|||Linear mixed model (LMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 2.||10.6|-29.8|0.2173
71790105|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|STANDARD_ERROR_OF_MEAN|12.95||0.1778|TWO_SIDED|90.0|-33.4|9.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 4.||9.4|-33.4|0.1778
71790106|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|16.37||0.1661|TWO_SIDED|90.0|-43.0|11.2|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 6.||11.2|-43.0|0.1661
71790107|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|17.66||0.1993|TWO_SIDED|90.0|-44.1|14.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 8.||14.3|-44.1|0.1993
71790108|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|19.66||0.0632|TWO_SIDED|90.0|-62.7|2.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 10.||2.3|-62.7|0.0632
71672047|NCT01671007|142862301|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.43|1.09|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.09|0.43|
71758323|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.47|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.38|-0.56|<0.0001
71838329|NCT05235750|143184203|OTHER||Mean Difference (Net)|0.2||||0.79|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for physical well-being (PWB) as measured by the FACT-G.|||||.79
71758324|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.37|-0.56|<0.0001
71758325|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.42|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.31||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.31|-0.54|<0.0001
71790109|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|19.71||0.1975|TWO_SIDED|90.0|-49.4|15.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 12.||15.8|-49.4|0.1975
71790110|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|12.25||0.5868|TWO_SIDED|90.0|-17.6|22.9|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 2.||22.9|-17.6|0.5868
71790111|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|12.93||0.0243|TWO_SIDED|90.0|-47.0|-4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 4.||-4.3|-47.0|0.0243
71790112|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.4|STANDARD_ERROR_OF_MEAN|16.12||0.0834|TWO_SIDED|90.0|-49.0|4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 6.||4.3|-49.0|0.0834
71790113|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.8|STANDARD_ERROR_OF_MEAN|17.43||0.0499|TWO_SIDED|90.0|-57.7|0.0|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 8.||-0.0|-57.7|0.0499
71790114|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.9|STANDARD_ERROR_OF_MEAN|19.45||0.0111|TWO_SIDED|90.0|-77.1|-12.7|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 10.||-12.7|-77.1|0.0111
71790115|NCT01287897|143077789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.5|STANDARD_ERROR_OF_MEAN|19.49||0.0221|TWO_SIDED|90.0|-71.7|-7.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 12.||-7.3|-71.7|0.0221
71790116|NCT01287897|143077790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|18.27||0.3157|TWO_SIDED|90.0|-39.0|21.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 2.||21.4|-39.0|0.3157
71790117|NCT01287897|143077790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|18.28||0.4171|TWO_SIDED|90.0|-34.0|26.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 4.||26.4|-34.0|0.4171
71672048|NCT01671007|142862305|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.88|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.88|0.38|
71892503|NCT01381094|143306466|SUPERIORITY||||||=|0.0069|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0069
71758326|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.51|-0.27||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.27|-0.51|<0.0001
71758327|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.43|||<|0.0001|TWO_SIDED|95.0|-0.56|-0.3||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.30|-0.56|<0.0001
71790118|NCT01287897|143077790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|18.79||0.3837|TWO_SIDED|90.0|-36.6|25.5|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 6.||25.5|-36.6|0.3837
71790119|NCT01287897|143077790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|19.27||0.3204|TWO_SIDED|90.0|-40.8|22.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 8.||22.8|-40.8|0.3204
71790120|NCT01287897|143077790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.9|STANDARD_ERROR_OF_MEAN|19.64||0.0649|TWO_SIDED|90.0|-62.3|2.6|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 10.||2.6|-62.3|0.0649
71790121|NCT01287897|143077790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.0|STANDARD_ERROR_OF_MEAN|19.87||0.0598|TWO_SIDED|90.0|-63.9|1.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 12.||1.8|-63.9|0.0598
71790122|NCT01969240|143077797|SUPERIORITY||Mean Difference (Final Values)|0.66|||||TWO_SIDED|95.0|0.46|0.86||||||||0.86|0.46|
71790123|NCT01969240|143077798|SUPERIORITY||||||<|0.013|||||||t-test, 2 sided|The a-priori significance level was 0.05.||||||<0.013
71790124|NCT01969240|143077799|SUPERIORITY||Mean Difference (Final Values)|10.3|||||TWO_SIDED|95.0|9.1|11.5||||||||11.5|9.1|
71790125|NCT01969240|143077800|SUPERIORITY|||||||0.998|||||||Regression, Logistic|||||||0.998
71790126|NCT01969240|143077801|SUPERIORITY||||||<|0.001|||||||negative binomial model|||||||<0.001
71790127|NCT01969240|143077802|SUPERIORITY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.8|-0.9||||||||-0.90|-4.8|
71790128|NCT01969240|143077803|SUPERIORITY||Median Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-0.2|3.6||||||||3.6|-0.2|
71790129|NCT00412854|143077808|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.61|||||TWO_SIDED|95.0|-1.68|3.39||||||"Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course."||3.39|-1.68|
71790130|NCT00412854|143077808|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
71790131|NCT00412854|143077809|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|2.47|||||TWO_SIDED|95.0|0.15|6.18||||||"Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||6.18|0.15|
71790132|NCT00412854|143077810|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
71838330|NCT05235750|143184203|OTHER||Mean Difference (Net)|-2.1||||0.05|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.05
71758328|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.23||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.23|-0.54|<0.0001
71758329|NCT02558296|143018913|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline HbA1c from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.27||||0.0045|TWO_SIDED|95.0|-0.47|-0.07||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories and BMI, history of heart failure, insulin use (Y/N), treatment, visit and baseline HbA1c as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in HbA1c from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.07|-0.47|0.0045
71758330|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 6 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.55|-1.15||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 6 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.15|-1.55|<0.0001
71758331|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 12 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 12 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.18|-1.61|<0.0001
71758332|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 24 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.39|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.16||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 24 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-1.16|-1.61|<0.0001
71790133|NCT00412854|143077810|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||TWO_SIDED|95.0|-2.29|2.3||||||"Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||2.30|-2.29|
71790134|NCT00412854|143077810|NON_INFERIORITY_OR_EQUIVALENCE|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference \[Infanrix+Hiberix Group minus Infanrix/Hib Group\] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|1.23|||||TWO_SIDED|95.0|-2.17|5.07||||||"Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."||5.07|-2.17|
71790135|NCT04483011|143077823|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.034|TWO_SIDED|||||\< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Dave 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.034
71790136|NCT04483011|143077823|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|2.79||0.265|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of Comparator.||||0.265
71790137|NCT04483011|143077823|SUPERIORITY||Mean Difference (Net)|2.12|STANDARD_DEVIATION|4.72||0.044|TWO_SIDED|||||\< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator groups.||||0.044
71838331|NCT05235750|143184203|OTHER||Mean Difference (Net)|-2.4||||0.03|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for social/family well-being (SWB) as measured by the FACT-G.|||||.03
71672049|NCT01671007|142862308|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.49|1.84|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.84|0.49|
71672050|NCT01671007|142862309|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.01|0.60|
71672051|NCT00391768|142862316|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Spearman Correlation|||||||0.07
71790138|NCT04483011|143077824|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.008|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation of RiaGev.||||0.008
71790139|NCT04483011|143077824|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_DEVIATION|1.34||0.297|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.297
71790140|NCT04483011|143077824|SUPERIORITY||Mean Difference (Net)|1.33|STANDARD_DEVIATION|1.88||0.04|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.04
71790141|NCT04483011|143077825|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.004|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in the RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.004
71790142|NCT04483011|143077825|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_DEVIATION|3.88||0.64|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.640
71790143|NCT04483011|143077825|SUPERIORITY||Mean Difference (Net)|4.01|STANDARD_DEVIATION|6.57||0.014|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 over Day 1 is reported.|A comparison between RiaGev and Comparator supplementation.||||0.014
71790144|NCT04483011|143077826|SUPERIORITY||Mean Difference (Net)|-1037.92|STANDARD_DEVIATION|1590.74||0.013|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 is reported.|A comparison before and after RiaGev supplementation.||||0.013
71790145|NCT04483011|143077826|SUPERIORITY||Mean Difference (Net)|-302.08|STANDARD_DEVIATION|1427.42||0.382|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 is reported.|A comparison before before and after supplementation with Comparator.||||0.382
71790146|NCT04483011|143077827|SUPERIORITY||Mean Difference (Net)|-135.13|STANDARD_DEVIATION|2153.66||0.793|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 8 over Day 1 baseline is reported.|A comparison between before and after RiaGev supplementation||||0.793
71790147|NCT04483011|143077827|SUPERIORITY||Mean Difference (Net)|-134.79|STANDARD_DEVIATION|1830.16||0.758|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 8 over Day 1 baseline is reported.|A comparison between before and after supplementation with Comparator.||||0.758
71790148|NCT04483011|143077828|SUPERIORITY||Mean Difference (Net)|70.2|STANDARD_DEVIATION|123.89||0.003|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation||||0.003
71790149|NCT04483011|143077828|SUPERIORITY||Mean Difference (Net)|15.55|STANDARD_DEVIATION|88.62||0.766|TWO_SIDED|||||p \> 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.766
71892504|NCT01381094|143306466|SUPERIORITY||||||=|0.0034|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0034
71672052|NCT00391768|142862316|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Spearman Correlation|||||||0.60
71672053|NCT00391768|142862316|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Spearman Correlation|||||||0.27
71672054|NCT00391768|142862316|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||Spearman Correlation|||||||0.77
71672055|NCT00391768|142862316|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Spearman Correlation|||||||0.47
71672056|NCT00391768|142862316|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Spearman Correlation|||||||0.96
71672057|NCT00449865|142862318|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Global Statistical Test|The global statistical test yielded t = -0.75 (2-sided p-value = .45, df=1865.8).||||||0.45
71790150|NCT04483011|143077829|SUPERIORITY||Mean Difference (Net)|24.01|STANDARD_DEVIATION|58.2||0.029|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups after 7-day supplementation.||||0.029
71790151|NCT04483011|143077830|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_DEVIATION|0.32||0.034|TWO_SIDED|||||p \< 0.05|ANCOVA||The p value between RiaGev and Comparator groups at Day 5 is reported.|A comparison between RiaGev and Comparator groups.||||0.034
71790152|NCT04483011|143077831|SUPERIORITY||Mean Difference (Net)|-8.33|STANDARD_DEVIATION|12.99||0.014|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in RiaGev group at Day 5 over Day 1 is reported.|A comparison between before and after RiaGev supplementation.||||0.014
71790153|NCT04483011|143077831|SUPERIORITY||Mean Difference (Net)|-2.56|STANDARD_DEVIATION|5.66||0.049|TWO_SIDED|||||p \< 0.05|Wilcoxon (Mann-Whitney)||The p value in Comparator group at Day 5 over Day 1 is reported.|A comparison between before and after supplementation with Comparator.||||0.049
71790154|NCT03518073|143077835|SUPERIORITY||Posterior Mean Ratio|1.1|||||TWO_SIDED|95.0|0.959|1.265|||||Posterior mean ratio with 95% credible interval is reported.|||1.265|0.959|
71790155|NCT03518073|143077835|SUPERIORITY||Posterior Mean Ratio|1.05|||||TWO_SIDED|95.0|0.907|1.209|||||Posterior mean ratio with 95% credible interval is reported.|||1.209|0.907|
71790156|NCT03518073|143077836|SUPERIORITY||Posterior Mean Ratio|1.11|||||TWO_SIDED|95.0|0.943|1.29|||||Posterior mean ratio with 95% credible interval is reported.|||1.290|0.943|
71790157|NCT03518073|143077836|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.737|1.053|||||Posterior mean ratio with 95% credible interval is reported.|||1.053|0.737|
71758333|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 36 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.89||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 36 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.89|-1.41|<0.0001
71758334|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 48 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.98||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 48 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.98|-1.48|<0.0001
71758335|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 72 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.72||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 72 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.72|-1.27|<0.0001
71758336|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 96 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 96 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.90|-1.50|<0.0001
71758337|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 120 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.82||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 120 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.82|-1.49|<0.0001
71758338|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 144 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.63||||0.0008|TWO_SIDED|95.0|-1.01|-0.24||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 144 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||-0.24|-1.01|0.0008
71758339|NCT02558296|143018914|NON_INFERIORITY|Rejection of the null hypothesis would imply that the mean change in baseline FPG from baseline to Week 168 was less than that in the placebo arm by a value that could not be attributed to chance alone.|Mean Difference (Final Values)|-0.5||||0.0462|TWO_SIDED|95.0|-1.09|0.08||P-value is based on one sided statistical tests using a 0.025 level of significance.|Mixed-effects repeated measures|Region, baseline eGFR categories \& BMI, history of HF, insulin use, treatment, visit, hypoglycemic use and baseline FPG as fixed effect covariate.||The null hypothesis for the exploratory endpoint was that the mean change in FPG from baseline to Week 168 in the bexagliflozin arm would be equal to or greater than the mean change in the placebo arm.||0.08|-1.09|0.0462
71758340|NCT02558296|143018915|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||0.41|0.22|<0.0001
71758341|NCT02558296|143018916|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.35|0.49||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during entire study.|||0.49|0.35|<0.0001
71790158|NCT03518073|143077837|SUPERIORITY||Posterior Mean Ratio|1.06|||||TWO_SIDED|95.0|0.873|1.284|||||Posterior mean ratio with 95% credible interval is reported.|||1.284|0.873|
71790159|NCT03518073|143077837|SUPERIORITY||Posterior Mean Ratio|1.21|||||TWO_SIDED|95.0|1.006|1.453|||||Posterior mean ratio with 95% credible interval is reported.|||1.453|1.006|
71790160|NCT03518073|143077838|SUPERIORITY||Posterior Mean Ratio|1.12|||||TWO_SIDED|95.0|0.963|1.3|||||Posterior mean ratio with 95% credible interval is reported.|||1.300|0.963|
71790161|NCT03518073|143077838|SUPERIORITY||Posterior Mean Ratio|0.95|||||TWO_SIDED|95.0|0.805|1.119|||||Posterior mean ratio with 95% credible interval is reported.|||1.119|0.805|
71790162|NCT03518073|143077839|SUPERIORITY||Posterior Mean Ratio|1.04|||||TWO_SIDED|95.0|0.88|1.221|||||Posterior mean ratio with 95% credible interval is reported.|||1.221|0.880|
71892505|NCT01381094|143306466|SUPERIORITY||||||=|0.0067|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0067
71892506|NCT01381094|143306466|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||<0.0001
71892507|NCT01381094|143306466|SUPERIORITY||||||=|0.0401|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 4).||||=0.0401
71672058|NCT00444535|142862319|OTHER|Clopper-Pearson exact test (binomial)|Exact binomial procedure|69.2||||||95.0|54.9|81.3||||||||81.3|54.9|
71672059|NCT00406367|142862326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||No type I-error adjustment was necessary in this study.|ANCOVA|Indepent variables in the model were treatment, baseline JRS-Severity score, gender, age, dose, and pooled center.||The null hypothesis in the analysis of covariance (ANCOVA) model was the absence of difference in the change from baseline in the JRS severity subscore between incobotulinumtoxinA (Xeomin) and placebo. The ANCOVA model was performed 2-sided (type-I error=5 percent) and change from baseline in the JRS Severity subscore assessed by a blinded Independent Rater as dependent variable. The independent variables were treatment, baseline JRS Severity subscore, gender, age, dose group, and pooled center.||-0.5|-1.4|<0.001
71758342|NCT02558296|143018917|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0005|TWO_SIDED|95.0|1.33|3.11||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the ratio of bexagliflozin over placebo.|||3.11|1.33|0.0005
71790163|NCT03518073|143077839|SUPERIORITY||Posterior Mean Ratio|0.89|||||TWO_SIDED|95.0|0.742|1.065|||||Posterior mean ratio with 95% credible interval is reported.|||1.065|0.742|
71790164|NCT03518073|143077840|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.253|TWO_SIDED|95.0|-0.01|0.05|||Mixed Models Analysis|||||0.05|-0.01|0.253
71790165|NCT03518073|143077840|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.354|TWO_SIDED|95.0|-0.02|0.05|||Mixed Models Analysis|||||0.05|-0.02|0.354
71790166|NCT03518073|143077841|SUPERIORITY||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|1.554||0.691|TWO_SIDED|95.0|-2.44|3.68|||Mixed Models Analysis|||||3.68|-2.44|0.691
71790167|NCT03518073|143077841|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.599||0.749|TWO_SIDED|95.0|-2.64|3.66|||Mixed Models Analysis|||||3.66|-2.64|0.749
71790168|NCT03045081|143077844|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. GEE allows for the analysis of repeated measures with unknown covariance structure and uses all available data that participants provide, even if follow-up data are missing (ie, intent-to-treat analysis). Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; i.e., as treated 'completer' analysis) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in pain self efficacy over time compared to the usual care group.||||<0.05
71790169|NCT03045081|143077844|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 values \< 0.05 considered statistically significant for group x time interactions.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain self-efficacy over time compared to the usual care group. This analysis was limited to those participants who provided data at each of the study time points ('completer analysis').||||<0.05
71790170|NCT03045081|143077845|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; 'study completers') were evaluated (see Statistical Analysis 2).||||||0.068||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group. Note: this questionnaire has 2 subscales, Activity Engagement and Pain Willingness. Intent-to-treat and as treated analyses were conducted for each subscale.||||0.068
71790171|NCT03045081|143077845|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \<0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group.This analysis was limited to those participants who provided data at each of the study time points ('completer' analysis).||||<0.05
71790172|NCT03045081|143077845|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.||||||0.173||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group.||||0.173
71790173|NCT03045081|143077845|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.167||||||Wald χ2 \>0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.167
71758343|NCT02558296|143018918|SUPERIORITY||Hazard Ratio (HR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.4|2.38||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for time to first event in the bexagliflozin arm vs. placebo arm during the entire study.|||2.38|1.40|<0.0001
71758344|NCT02558296|143018919|SUPERIORITY||Odds Ratio (OR)|0.63||||0.0803|TWO_SIDED|95.0|0.33|1.2||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.20|0.33|0.0803
71758345|NCT02558296|143018919|SUPERIORITY||Odds Ratio (OR)|0.47||||0.0272|TWO_SIDED|95.0|0.22|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Logistic|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Odds ratio is calculated as the odds ratio of bexagliflozin over placebo.|||1.01|0.22|0.0272
71758346|NCT02558296|143018919|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0757|TWO_SIDED|95.0|0.34|1.18||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.18|0.34|0.0757
71758347|NCT02558296|143018919|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0273|TWO_SIDED|95.0|0.23|1.01||P-value is based on one sided statistical tests using a 0.025 level of significance.|Regression, Cox|Region, baseline eGFR categories \& BMI, history of heart failure, insulin use (Y/N), treatment and baseline HbA1c as fixed effect covariate.|Hazard ratio and p-value were estimated using Cox regression model for treatment comparison vs. placebo.|||1.01|0.23|0.0273
71758348|NCT01055197|143019005|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.2103|TWO_SIDED|95.0|0.82|2.53|||Log Rank|||The null hypothesis (H0) was that PCI + RT is not effective versus the alternative hypothesis (H1) that PCI + RT is effective. Assumptions were that PCI alone would have hazard rate λc of 1.204 and PCI + RT a hazard rate λc of 0.799 (hazard ratio λt/λc = 0.663). At each planned analysis, the p-value from the log-rank test statistic assessing overall survival was compared to the nominal significance level. The final targeted accrual was 154.||2.53|0.82|0.2103
71758349|NCT01055197|143019006|SUPERIORITY|||||||0.24|||||||Fisher Exact|2-sided significance level of 0.05||||||0.24
71758350|NCT01055197|143019008|SUPERIORITY|||||||0.0102|||||||Log Rank|2-sided significance level of 0.05||||||0.0102
71790174|NCT03045081|143077846|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.176||||||Wald χ2 p-values \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group.||||0.176
71790175|NCT03045081|143077846|OTHER|Generalized estimating equations were used to test this hypothesis.||||||0.143||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).||||0.143
71790176|NCT03045081|143077847|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group.||||<0.05
71790177|NCT03045081|143077847|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.001||||||Wald χ2 \< 0.05 were considered statistically significant for the group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points (i.e., 'completer' analysis).||||<0.001
71790178|NCT03045081|143077849|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.102||||||Wald χ2 p-values \< 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group.||||0.102
71790179|NCT03045081|143077849|OTHER|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 \< 0.05 considered statistically significant for group x time interaction|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each time point (as treated, 'completer' analysis).||||<0.05
71790180|NCT01853046|143077850|SUPERIORITY_OR_OTHER||LS Mean|1.14|||||TWO_SIDED|90.0|0.796|1.63||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of regorafenib calculated by re-transformation of the logarithmic data from ANOVAs.||1.63|0.796|
71672060|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% confidence intervals (CIs) for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.5|7.4||||||15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The mixed model for repeated measurements (MMRM) included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.4|0.5|
71758351|NCT00538902|143019013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.026||95.0|1.09|4.39||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||4.39|1.09|0.026
71758352|NCT00538902|143019013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.004||95.0|1.35|5.3||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.||5.30|1.35|0.004
71758353|NCT00538902|143019014|SUPERIORITY_OR_OTHER|||||||0.009||||||The between-treatment comparison between each adalimumab group vs. placebo was performed at the 2-sided alpha = 0.05 significance level, without using a stepwise testing procedure or alpha adjustment.|Cochran-Mantel-Haenszel|Percentage ACR responders at Week 12 were compared between adalimumab and placebo groups, where missing ACR responses were imputed as non-responder.||||||0.009
71758354|NCT00538902|143019014|SUPERIORITY_OR_OTHER|||||||0.121|||||||Cochran-Mantel-Haenszel|||||||0.121
71758355|NCT03739203|143019030|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.88||0.6798|TWO_SIDED|95.0|-2.1|1.37||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||1.37|-2.10|0.6798
71758356|NCT03739203|143019030|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1245|TWO_SIDED|95.0|-3.11|0.38||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.38|-3.11|0.1245
71790181|NCT01853046|143077850|SUPERIORITY_OR_OTHER||LS-means|0.684|||||TWO_SIDED|90.0|0.397|1.18||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-2 calculated by re-transformation of the logarithmic data from ANOVAs.||1.18|0.397|
71790182|NCT01853046|143077850|SUPERIORITY_OR_OTHER||LS-means|0.446|||||TWO_SIDED|90.0|0.2|0.996||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-5 calculated by re-transformation of the logarithmic data from ANOVAs||0.996|0.200|
71790183|NCT00065507|143077882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.18|||Regression, Linear|Linear regression model adjusted for baseline HBV DNA and LVDr status.||||-1.18|-2.30|<0.0001
71790184|NCT00065507|143077883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.85|-0.96|||Regression, Linear|adjusted for baseline HBV DNA and LVDr Status||||-0.96|-1.85|<0.0001
71790185|NCT00065507|143077884|SUPERIORITY_OR_OTHER||Mean Percent Difference|32.7|||<|0.0001|TWO_SIDED|95.0|20.2|45.2|||Cochran-Mantel-Haenszel|||||45.2|20.2|<0.0001
71790186|NCT00065507|143077885|SUPERIORITY_OR_OTHER||Mean percent treatment difference|38.0|||<|0.0001|TWO_SIDED|95.0|24.8|50.3|||Cochran-Mantel-Haenszel|||||50.3|24.8|<0.0001
71790187|NCT00065507|143077886|SUPERIORITY_OR_OTHER||percent treatment difference|19.2||||0.0193|TWO_SIDED|95.0|3.7|34.6|||Cochran-Mantel-Haenszel|||Week 24 treatment difference||34.6|3.7|0.0193
71790188|NCT00065507|143077886|SUPERIORITY_OR_OTHER||percent treatment difference|16.4||||0.0425|TWO_SIDED|95.0|0.9|32.0|||Cochran-Mantel-Haenszel|||Week 48 treatment difference||32.0|0.9|0.0425
71790189|NCT00065507|143077892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.51|TWO_SIDED|95.0|-1.63|0.82|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 24||0.82|-1.63|0.51
71790190|NCT00065507|143077892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|||<|0.0001|TWO_SIDED|95.0|-1.08|1.88|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 48||1.88|-1.08|<0.0001
71790191|NCT00065507|143077900|SUPERIORITY_OR_OTHER||Difference Estimate|10.4|||||TWO_SIDED|95.0|-4.5|25.2||||||Difference estimate ETV - ADV at Week 48||25.2|-4.5|
71790192|NCT00065507|143077901|SUPERIORITY_OR_OTHER||Difference Estimate|-0.4|||||TWO_SIDED|95.0|-8.7|8.0||||||Difference Estimate at Week 48||8.0|-8.7|
71790193|NCT00065507|143077902|SUPERIORITY_OR_OTHER||Difference Estimate|-7.2|||||TWO_SIDED|95.0|-21.3|6.9||||||Difference Estimate at Week 48||6.9|-21.3|
71790194|NCT00065507|143077903|SUPERIORITY_OR_OTHER||Difference Estimate|5.7|||||TWO_SIDED|95.0|-0.3|11.7||||||Difference Estimate at Week 48||11.7|-0.3|
71790195|NCT00065507|143077904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2|TWO_SIDED|95.0|0.46|1.18|||Regression, Cox|Cox proportional hazard model, adjusted for age \<=45 versus age \>45 years, gender, and race (white versus non-white).||treatment comparison of HCC-free survival at Week 48||1.18|0.46|0.20
71790196|NCT02493608|143077912|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71790197|NCT02493608|143077913|OTHER|||||||0.218||||||POD 1|t-test, 2 sided|||||||0.218
71790198|NCT02493608|143077913|OTHER|||||||0.638||||||POD 2|t-test, 2 sided|||||||0.638
71790199|NCT02493608|143077914|OTHER|||||||0.113|||||||t-test, 2 sided|||||||0.113
71790200|NCT00665353|143077928|SUPERIORITY_OR_OTHER||proportion|0.158||||0.29|ONE_SIDED|90.0|0.059|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.10. The hypothesized response rate was 0.30.|||0.059|0.29
71790201|NCT00665353|143077931|SUPERIORITY_OR_OTHER||proportion|0.053||||0.42|ONE_SIDED|90.0|0.001|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.02. The hypothesized response rate was 0.15.|||0.001|0.42
71790202|NCT02632552|143077939|EQUIVALENCE|Using a pre-intervention rate of 18 for both intervention and control, and a post-control change of 1, assuming an alpha of 0.05, we have power (0.8) to detect a difference of differences in change in mean urgent care/ED utilization of 0.75 with a standard deviation equal to the control mean; however, the equivalence boundary did not apply because this is a pragmatic trial.|Incidence Rate Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.15||0.45|TWO_SIDED|95.0|0.85|1.45|||Mixed Effects Negative Binomial Model|A segmented negative binomial regression model was used to estimate changes in ED/urgent care utilization between the intervention and control groups.||||1.45|0.85|0.45
71790203|NCT02632552|143077940|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-1.8||||0.05|TWO_SIDED|95.0|-7.21|3.61|||Mixed Models Analysis|||||3.61|-7.21|0.05
71790204|NCT02632552|143077941|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.38||0.03|TWO_SIDED|95.0|0.08|1.57|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.57|0.08|0.03
71790205|NCT02632552|143077942|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.75|TWO_SIDED|95.0|-0.41|0.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.29|-0.41|0.75
71790206|NCT02632552|143077943|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||0.70|-0.50|0.74
71790207|NCT02632552|143077944|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.87||0.63|TWO_SIDED|95.0|-2.21|1.29|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||1.29|-2.21|0.63
71790208|NCT02632552|143077945|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta of Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|1.26||0.23|TWO_SIDED|95.0|-0.97|4.05|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||4.05|-0.97|0.23
71790209|NCT02632552|143077946|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|2.8||0.38|TWO_SIDED|95.0|-7.95|3.1||MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.|Mixed Models Analysis|||||3.10|-7.95|0.38
71790210|NCT02632552|143077947|EQUIVALENCE|We initially powered at 80% to detect an effect size of 0.5 for all secondary outcomes; however, the equivalence boundary did not apply because this is a pragmatic trial.|Beta for the Mean Difference|-2.79|STANDARD_ERROR_OF_MEAN|3.2||0.38|TWO_SIDED|95.0|-9.1|3.52|||Mixed Models Analysis|MMA by group, time, and group by time as predictors. We also adjusted by: Marital Status and indicator variable for problems learning online.||||3.52|-9.10|0.38
71790211|NCT02707991|143078003|SUPERIORITY||Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|0.115||0.036|ONE_SIDED|||||one-sided test|z-test for difference in proportions|||||||0.036
71790212|NCT01528254|143078062|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.001|TWO_SIDED|95.0|0.45|0.58|||Regression, Cox|||||0.58|0.45|<0.001
71790213|NCT01528254|143078063|OTHER||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.042|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|||||0.00|-0.05|0.042
71790214|NCT01528254|143078064|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.635|TWO_SIDED|95.0|-0.29|0.47|||Mixed Models Analysis|||||0.47|-0.29|0.635
71790215|NCT01528254|143078065|OTHER||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.53|TWO_SIDED|95.0|-0.05|0.02|||Mixed Models Analysis|||||0.02|-0.05|0.530
71790216|NCT01528254|143078066|OTHER||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.32||0.381|TWO_SIDED|95.0|-0.35|0.9|||Mixed Models Analysis|||||0.90|-0.35|0.381
71790217|NCT01528254|143078067|OTHER||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.23||0.744|TWO_SIDED|95.0|-0.53|0.38|||Mixed Models Analysis|||From Week 13 to end of Period 1||0.38|-0.53|0.744
71790218|NCT01528254|143078067|OTHER||Slope|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.017|TWO_SIDED|95.0|-0.91|-0.09|||Mixed Models Analysis|||From Week 13 to end of Period 2||-0.09|-0.91|0.017
71790219|NCT01528254|143078067|OTHER||Slope|-0.58|STANDARD_ERROR_OF_MEAN|0.21||0.006|TWO_SIDED|95.0|-0.99|-0.17|||Mixed Models Analysis|||From Week 13 to end of study||-0.17|-0.99|0.006
71790220|NCT01528254|143078068|OTHER||Slope|-5.03|STANDARD_ERROR_OF_MEAN|2.16||0.02|TWO_SIDED|95.0|-9.26|-0.79|||Mixed Models Analysis|||From Week 13 to end of Period 1||-0.79|-9.26|0.020
71892508|NCT01381094|143306466|SUPERIORITY||||||=|0.0042|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0042
71758357|NCT03739203|143019031|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.5152|TWO_SIDED|95.0|-0.29|0.15||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG),ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.15|-0.29|0.5152
71758358|NCT03739203|143019031|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0573|TWO_SIDED|95.0|-0.43|0.01||p-value estimated by Mixed-effects Model for Repeated Measure from test of no difference between cariprazine dose group and placebo at Week 6.|MMRM|MMRM=Fixed effects:treatment group(TG), ADT failure category,visit,TG-by-visit;Covariates:Baseline(BL)value\& BL by-visit interaction.||||0.01|-0.43|0.0573
71758359|NCT01782378|143019042|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.33|<|0.01|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.01
71758360|NCT01782378|143019043|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.88||0.88|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.88
71758361|NCT01782378|143019044|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.59||0.81|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||0.81
71758362|NCT01782378|143019045|SUPERIORITY||Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|2.88||0.23|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||0.23
71758363|NCT01782378|143019046|SUPERIORITY||Mean Difference (Final Values)|11.39|STANDARD_ERROR_OF_MEAN|7.08|<|0.12|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.12
71790221|NCT01528254|143078068|OTHER||Slope|-5.08|STANDARD_ERROR_OF_MEAN|1.73||0.003|TWO_SIDED|95.0|-8.46|-1.69|||Mixed Models Analysis|||From Week 13 to end of Period 2||-1.69|-8.46|0.003
71790222|NCT01528254|143078068|OTHER||Slope|-5.38|STANDARD_ERROR_OF_MEAN|1.64||0.001|TWO_SIDED|95.0|-8.61|-2.16|||Mixed Models Analysis|||From Week 13 to end of study||-2.16|-8.61|0.001
71790223|NCT04339296|143078070|EQUIVALENCE|An independent sample t-test was performed between intervention and control group to determine if the difference of the mean medication adherence is equal to zero (null hypothesis).|Mean Difference (Net)|7.18|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Medication Adherence Difference = Intervention Adherence - Control Adherence|||||<0.01
71790224|NCT04339296|143078071|EQUIVALENCE|The null hypothesis assumes that the true mean difference for intervention participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.5|||<|0.01|TWO_SIDED|||||Statistical test was set at 95% confidence level.|t-test, 2 sided||Mean difference (intervention participants self-reported score) = baseline minus 6-month.|||||<0.01
71790225|NCT04339296|143078071|EQUIVALENCE|The null hypothesis assumes that the true mean difference for control participants self-reported medication adherence scores (from baseline to 6-month) is equal to zero.|Mean Difference (Net)|-1.07||||0.07|TWO_SIDED|||||Statistical tests was set at 95% confidence level.|t-test, 2 sided||Mean difference (control participants self-reported score) = baseline minus 6-month.|||||0.07
71790226|NCT04446377|143078079|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would induce greater changes in viral load from Day 1 to Day 4 than would Placebo.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.35|TWO_SIDED|95.0|-1.47|0.53||Pre-specified 2-sided significance level of 0.20|Mixed Models Analysis|ANCOVA linear mixed model to evaluate the relative differences between the LAM-002A and Placebo groups in the log10 viral load from Day 1 to Day 4.|The difference between the groups (LAM-002A vs Placebo).|The analysis tested whether the viral load in nasopharyngeal samples was lower at Day 4 in those receiving LAM-002A compared to Placebo.||0.53|-1.47|0.35
71892509|NCT01381094|143306466|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71758364|NCT01782378|143019047|SUPERIORITY||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.93|<|0.52|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.52
71758365|NCT01782378|143019048|SUPERIORITY||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|3.51|<|0.27|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.27
71758366|NCT01782378|143019049|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|2.26|<|0.37|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.37
71758367|NCT01782378|143019050|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.78|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
71790227|NCT04446377|143078081|SUPERIORITY|The alternative hypothesis for the statistical testing was that LAM-002A would reduce the cumulative rate of hospitalization or death during the 28-day period comprising 10 days of study drug administration and a further 18 days of observation.|Odds Ratio (OR)|2.03||||0.55|TWO_SIDED|95.0|0.18|22.89|||Log Rank|||||22.89|0.18|0.55
71672061|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-0.5|6.5||||||30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||6.5|-0.5|
71672062|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|0.2|7.2||||||45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||7.2|0.2|
71677219|NCT04143594|142873013|SUPERIORITY||Difference in LSM|21.0||||0.6614|TWO_SIDED|95.0|-73.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-73|0.6614
71790228|NCT04446377|143078083|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.4|||||TWO_SIDED|||||||||Risk Difference from generalized estimating equations (GEE) logistic regression at Baseline||||
71790229|NCT04446377|143078083|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-1.0|||||TWO_SIDED|||||||||Risk Difference from GEE Logistic Regression at Day 1||||
71790230|NCT04446377|143078083|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-8.8|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 4||||
71790231|NCT04446377|143078083|SUPERIORITY|The alternative hypothesis for the statistical testing was that a higher proportion of participants would have ≥95% oxygen saturation during LAM-002A administration than during Placebo administration as assessed across Days 1, 4, and 11 of the study drug course.|Risk Difference (RD)|-3.7|||||TWO_SIDED|||||||||Risk Difference from GEE logistic regression at Day 11||||
71790232|NCT04446377|143078084|SUPERIORITY|The alternative hypothesis for the statistical testing was that, relative to Placebo, LAM-002A would result in a greater proportion of participants with a SARS-CoV-2 viral load \<LLOQ on Day 4.|Relative Risk|2.51||||0.2|TWO_SIDED|95.0|0.74|8.48||Prespecified significance level of 0.20.|Fisher Exact|||||8.48|0.74|0.20
71790233|NCT03194698|143078121|SUPERIORITY|||||||0.0312|||||||Wilcoxon (Mann-Whitney)|||||||0.0312
71790234|NCT03194698|143078122|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71790235|NCT03194698|143078123|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71790236|NCT02625259|143078124|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.36|||||TWO_SIDED|90.0|1.0|1.83||||||Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.||1.83|1.00|
71892510|NCT01381094|143306466|SUPERIORITY||||||=|0.0002|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0002
71790237|NCT02625259|143078124|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.2|||||TWO_SIDED|90.0|0.86|1.67||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.||1.67|0.86|
71790238|NCT02625259|143078124|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.03|||||TWO_SIDED|90.0|0.02|0.07||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.07|0.02|
71790239|NCT02625259|143078126|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.47|||||TWO_SIDED|90.0|0.98|2.18||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.||2.18|0.98|
71790240|NCT02625259|143078126|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.76|||||TWO_SIDED|90.0|1.11|2.78||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.||2.78|1.11|
71790241|NCT02625259|143078126|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.02|||||TWO_SIDED|90.0|0.01|0.04||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.04|0.01|
71790242|NCT02625259|143078127|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.53|||||TWO_SIDED|90.0|0.93|2.51||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.||2.51|0.93|
71790243|NCT02625259|143078127|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.5|||||TWO_SIDED|90.0|1.0|2.25||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.||2.25|1.00|
71790244|NCT02625259|143078127|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.08|||||TWO_SIDED|90.0|0.03|0.18||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.||0.18|0.03|
71790245|NCT00513474|143078135|SUPERIORITY|||||||0.036|||||||Gray's test for competing risks|||||||.036
71672063|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|2.7|9.7||||||60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||9.7|2.7|
71672064|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|1.3|8.3||||||2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||8.3|1.3|
71672065|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Square (LS) Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-1.7|5.3||||||3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||5.3|-1.7|
71672066|NCT03187301|142862346|NON_INFERIORITY|For each post-dose time point, change from baseline (ΔQTcF) was compared between APL-130277 and placebo (ΔΔQTcF). The hypothesis of no clinical difference was accepted, if all upper limits of the two-sided 90% CIs for APL-130277 versus placebo fell below 10 msec.|Least Sqaure (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.12||||90.0|-4.2|2.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||2.8|-4.2|
71672067|NCT03187301|142862351|NON_INFERIORITY|15 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.3|8.6||||||||8.6|0.3|
71838332|NCT05235750|143184203|OTHER||Mean Difference (Net)|-0.2||||0.82|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.82
71758368|NCT01782378|143019051|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.68|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.46
71758369|NCT01782378|143019052|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.83|<|0.84|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.84
71758370|NCT01782378|143019053|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.75|<|0.93|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.93
71758371|NCT01782378|143019054|SUPERIORITY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|3.02|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
71758372|NCT01782378|143019055|SUPERIORITY|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|Mean Difference (Final Values)|-14.43|STANDARD_ERROR_OF_MEAN|12.54|<|0.26|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results that were considered credible.||||||<0.26
71758373|NCT01782378|143019056|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.7|<|0.45|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.45
71758374|NCT01782378|143019057|SUPERIORITY||Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|1.18|<|0.46|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.46
71838333|NCT05235750|143184203|OTHER||Mean Difference (Net)|-0.5||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for emotional well-being (EWB) as measured by the FACT-G.|||||.58
71672068|NCT03187301|142862351|NON_INFERIORITY|30 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-1.6|6.7||||||||6.7|-1.6|
71672069|NCT03187301|142862351|NON_INFERIORITY|45 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.4||||||||7.4|-0.9|
71672070|NCT03187301|142862351|NON_INFERIORITY|60 mins post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|-0.9|7.5||||||||7.5|-0.9|
71672071|NCT03187301|142862351|NON_INFERIORITY|2 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|90.0|0.8|9.2||||||||9.2|0.8|
71672072|NCT03187301|142862351|NON_INFERIORITY|3 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|0.4|8.8||||||||8.8|0.4|
71672073|NCT03187301|142862351|NON_INFERIORITY|4 hours post-dose: time-matched, baseline-corrected comparison between APL-130277 and placebo using the ΔΔQTcB approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcB as a covariate. The patient nested within sequence was included as a random effect|Least Square (LS) Mean Differeence|2.6|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|90.0|-1.6|6.9||||||||6.9|-1.6|
71672074|NCT03187301|142862355|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.0|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|5.3|14.8||||||60 mins post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||14.8|5.3|
71758375|NCT01782378|143019058|SUPERIORITY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.44|<|0.64|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.64
71758376|NCT01782378|143019059|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.63|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.82
71758377|NCT01782378|143019060|SUPERIORITY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.53|<|0.43|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.43
71758378|NCT01782378|143019061|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.15|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.15
71758379|NCT01782378|143019062|SUPERIORITY||Mean Difference (Final Values)|3.36|STANDARD_ERROR_OF_MEAN|1.86||0.08|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||.08
71758380|NCT01782378|143019063|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.83|<|0.7|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.7
71790246|NCT00665847|143078144|SUPERIORITY_OR_OTHER||Proportion|52.5|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|42.7|62.2|||||The standard error for a proportion was calculated as the square root of the variance divided by the number of patients. The variance for a proportion is equal to p\*(1-p), with p being the proportion.|||62.2|42.7|
71790247|NCT01705288|143078281|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.36
71672075|NCT03187301|142862355|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|7.5|17.1||||||2 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||17.1|7.5|
71790248|NCT01705288|143078282|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis||||0.05
71758381|NCT01782378|143019064|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5|<|0.48|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.48
71758382|NCT01782378|143019065|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.16|<|0.02|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.02
71758383|NCT01782378|143019066|SUPERIORITY||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.19|<|0.36|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.36
71790249|NCT01705288|143078283|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71790250|NCT01662908|143078311|OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|10.74|||TWO_SIDED|95.0|-12.7|30.2||||||||30.2|-12.7|
71790251|NCT00613938|143078337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.4|STANDARD_ERROR_OF_MEAN|11.9|<|0.001||95.0|39.01|85.73||Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.|ANCOVA||The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.|Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.||85.73|39.01|<0.001
71790252|NCT02636868|143078343|SUPERIORITY|||||||0.363||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO₂) in model||Null hypothesis is no difference across treatment groups||||0.363
71790253|NCT02636868|143078343|SUPERIORITY|||||||0.36||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.360
71790254|NCT02636868|143078343|SUPERIORITY|||||||0.461||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatments||||0.461
71790255|NCT02636868|143078344|SUPERIORITY|||||||0.401||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.401
71790256|NCT02636868|143078344|SUPERIORITY|||||||0.372||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.372
71790257|NCT02636868|143078344|SUPERIORITY|||||||0.648||||||a priori threshold of statistical significance set at 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis is no difference across treatment groups||||0.648
71758384|NCT01782378|143019067|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.88|<|0.82|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.82
71790258|NCT02636868|143078345|SUPERIORITY|||||||0.996||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference across treatments||||0.996
71790259|NCT02636868|143078345|SUPERIORITY|||||||0.951||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.951
71790260|NCT02636868|143078345|SUPERIORITY|||||||0.995||||||a priori threshold of statistical significance set at 0.05|Log Rank|||Null hypothesis of no difference between treatments||||0.995
71790261|NCT02636868|143078346|SUPERIORITY|||||||0.312||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.312
71790262|NCT02636868|143078346|SUPERIORITY|||||||0.094||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model||Null hypothesis of no difference between treatment groups||||0.094
71790263|NCT02636868|143078346|SUPERIORITY|||||||0.414||||||A priori threshold of statistical significance set at 0.10|Regression, Linear|Generalized linear model using Poisson distribution with pooled site, treatment, gender, birth weight, and baseline FiO₂ in model.||Null hypothesis of no difference between treatment groups||||0.414
71790264|NCT02636868|143078347|SUPERIORITY|||||||0.099||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline fraction of inspired oxygen (FiO2) in model||Null hypothesis of no difference between treatment groups||||0.099
71790265|NCT02636868|143078347|SUPERIORITY|||||||0.09||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatments||||0.090
71790266|NCT02636868|143078347|SUPERIORITY|||||||0.461||||||A priori statistical significance of 0.05|Regression, Logistic|Pooled site, treatment, gender, birth weight, and baseline FiO2 in model||Null hypothesis of no difference between treatment groups||||0.461
71790267|NCT02636868|143078348|SUPERIORITY|||||||0.534||||||A priori threshold for statistical significance set at 0.05|ANOVA|treatment and pooled site in model||Null hypothesis of no treatment between treatments||||0.534
71790268|NCT02636868|143078348|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.480
71790269|NCT02636868|143078348|SUPERIORITY|||||||0.313||||||A priori threshold for statistical significance set at 0.05|ANOVA|Treatment and pooled site in model||Null hypothesis of no difference between treatment groups||||0.313
71758385|NCT01782378|143019068|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.84|<|0.2|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.2
71758386|NCT01782378|143019069|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.86|<|0.71|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results||||||<0.71
71758387|NCT01782378|143019070|SUPERIORITY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.73|<|0.85|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.85
71758388|NCT01782378|143019071|SUPERIORITY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.94|<|0.44|TWO_SIDED|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p\<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.||||||<0.44
71758389|NCT01967940|143019076|SUPERIORITY|Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.|Difference in proportions|60.7|||<|0.001|TWO_SIDED|95.0|42.6|78.8|||Fisher Exact||The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.||78.8|42.6|<0.001
71758390|NCT04266717|143019122|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71758391|NCT00940771|143019123|OTHER|Friedman's Test|Chi Square|12.3||||0.006|TWO_SIDED||||||Friedman's Test|3 degrees of freedom.||||||.006
71758392|NCT00940771|143019123|OTHER|Post Hoc testing Post hoc Wilcoxon Signed Rank tests||||||0.007|||||||Wilcoxon Signed Rank|Z=-2.701||Nul lHypothesis that there is no difference between specific time points.||||.007
71758393|NCT00940771|143019124|OTHER|Friedman's test with 3 df||||||0.356|||||||Friedman's Test|3 degrees of freedom||||||.356
71758394|NCT00940771|143019125|OTHER||Chi-square|1.0||||0.801|TWO_SIDED||||||Friedman's test|3 degrees of freedom|1.0 is the actual calculated Chi-X value, not the p value.|The null hypothesis was that there was a difference. We were looking for no difference between before and after switch.||||.801
71758395|NCT00940771|143019126|OTHER|Friedman's test||||||0.075||||||a priori threshold for statistical significance 0.05|Friedman's test|3 degrees of freedom||||||.075
71758396|NCT02593006|143019135|SUPERIORITY||Risk Difference (RD)|10.3|||>|0.05|TWO_SIDED|95.0|-3.2|23.8|||Propensity weighted regression model|||||23.8|-3.2|>0.05
71758397|NCT02593006|143019136|SUPERIORITY|||||||0.04||||||Global test of interaction between time and treatment group.|Mixed Models Analysis|||||||0.04
71758398|NCT02420821|143019144|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0205|TWO_SIDED|95.0|0.57|0.95|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.95|0.57|0.0205
71758399|NCT02420821|143019146|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2675|TWO_SIDED|95.0|0.76|1.08|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.08|0.76|0.2675
71758400|NCT02420821|143019148|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.263|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.13|0.64|0.263
71758401|NCT02420821|143019150|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1218|TWO_SIDED|95.0|0.74|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.04|0.74|0.1218
71758402|NCT02420821|143019152|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6138|TWO_SIDED|95.0|0.72|1.21|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.21|0.72|0.6138
71790270|NCT02127567|143078426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.5|2.7|||Mixed Models Analysis|||||2.7|1.5|<0.001
71790271|NCT02127567|143078427|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.01|TWO_SIDED|95.0|1.1|4.4|||Mixed Models Analysis|||||4.4|1.1|<0.01
71790272|NCT02127567|143078428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.44|TWO_SIDED|95.0|-0.7|2.0|||Mixed Models Analysis|||||2.0|-0.7|0.44
71790273|NCT02127567|143078429|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.01|TWO_SIDED|95.0|0.8|3.6|||Mixed Models Analysis|||||3.6|0.8|<0.01
71790274|NCT02127567|143078430|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.8|||<|0.01|TWO_SIDED|95.0|0.7|2.9|||Mixed Models Analysis|||||2.9|0.7|<0.01
71790275|NCT02127567|143078431|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.78|TWO_SIDED|95.0|-2.0|1.3|||Mixed Models Analysis|||||1.3|-2.0|0.78
71790276|NCT02127567|143078432|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.01|TWO_SIDED|95.0|4.1|6.7|||Mixed Models Analysis|||||6.7|4.1|<0.01
71790277|NCT02127567|143078433|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.002|TWO_SIDED|95.0|0.5|2.3|||Mixed Models Analysis|||||2.3|0.5|0.002
71790278|NCT00786487|143078434|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71790279|NCT00786487|143078434|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71677220|NCT04143594|142873013|SUPERIORITY||Difference in LSM|20.0||||0.6791|TWO_SIDED|95.0|-75.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-75|0.6791
71758403|NCT02420821|143019153|SUPERIORITY||Difference in Response Rates|3.3||||0.2733|TWO_SIDED|95.0|-3.09|9.7|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||9.70|-3.09|0.2733
71758404|NCT02420821|143019155|SUPERIORITY||Difference in Response Rates|1.96||||0.5121|TWO_SIDED|95.0|-4.32|8.24|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||8.24|-4.32|0.5121
71758405|NCT02420821|143019158|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0606|TWO_SIDED|95.0|0.71|1.01|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.01|0.71|0.0606
71758406|NCT02420821|143019159|SUPERIORITY||Difference in Response Rates|5.09||||0.1011|TWO_SIDED|95.0|-1.4|11.58|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||11.58|-1.40|0.1011
71758407|NCT02420821|143019162|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0254|TWO_SIDED|95.0|0.7|0.98|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.98|0.70|0.0254
71758408|NCT02420821|143019164|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.002|TWO_SIDED|95.0|0.34|0.79|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||0.79|0.34|0.0020
71758409|NCT02420821|143019166|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0497|TWO_SIDED|95.0|0.43|1.0|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).||1.00|0.43|0.0497
71758410|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.74|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.43|-1.06|<0.0001
71758411|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.2||||0.2085|TWO_SIDED|95.0|-0.51|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-0.51|0.2085
71758412|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.71|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.71|-1.33|<0.0001
71758413|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.51||||0.0013|TWO_SIDED|95.0|-0.82|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-0.82|0.0013
71758414|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.7|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.70|-1.34|<0.0001
71758415|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.43||||0.0098|TWO_SIDED|95.0|-0.76|-0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.10|-0.76|0.0098
71758416|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.65|-1.32|<0.0001
71838334|NCT05235750|143184203|OTHER||Mean Difference (Net)|-0.8||||0.56|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.56
71838335|NCT05235750|143184203|OTHER||Mean Difference (Net)|-0.7||||0.58|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for functional well-being (FWB) as measured by the FACT-G.|||||.58
71677221|NCT04143594|142873013|SUPERIORITY||Difference in LSM|27.0||||0.5563|TWO_SIDED|95.0|-65.0|120.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||120|-65|0.5563
71838336|NCT05235750|143184203|OTHER||Mean Difference (Net)|-0.2||||0.58|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.58
71758417|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.46||||0.008|TWO_SIDED|95.0|-0.8|-0.12|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.12|-0.80|0.0080
71758418|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.44|-1.13|<0.0001
71758419|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.21||||0.2512|TWO_SIDED|95.0|-0.56|0.15|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.15|-0.56|0.2512
71758420|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.65||||0.0005|TWO_SIDED|95.0|-1.01|-0.28|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.28|-1.01|0.0005
71758421|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.43||||0.0247|TWO_SIDED|95.0|-0.8|-0.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.05|-0.80|0.0247
71758422|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.39|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.39|-1.15|<0.0001
71758423|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.29||||0.1411|TWO_SIDED|95.0|-0.68|0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.10|-0.68|0.1411
71758424|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.65||||0.0014|TWO_SIDED|95.0|-1.05|-0.25|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.25|-1.05|0.0014
71758425|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.37||||0.0728|TWO_SIDED|95.0|-0.78|0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.03|-0.78|0.0728
71758426|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.49|-1.32|<0.0001
71790280|NCT02057198|143078444|SUPERIORITY||Slope|-0.15||||0.52|TWO_SIDED|95.0|-0.34|0.05||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.05|-0.34|0.52
71790281|NCT02057198|143078444|SUPERIORITY||Slope|-0.17||||0.66|TWO_SIDED|95.0|-0.69|0.35||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||||0.35|-0.69|0.66
71790282|NCT02057198|143078445|SUPERIORITY||||||<|0.001|||||||Chi square (2 proportion test)|||||||<0.001
71790283|NCT02057198|143078445|SUPERIORITY|||||||0.01|||||||Chi square (2 proportion test)|||||||0.01
71790284|NCT02057198|143078446|SUPERIORITY|||||||0.99|||||||Chi square (2 proportion test)|||||||0.99
71790285|NCT02057198|143078446|SUPERIORITY|||||||0.52|||||||Chi square (2 proportion test)|||||||0.52
71790286|NCT02057198|143078447|SUPERIORITY||Slope|-0.43||||0.05|TWO_SIDED|95.0|-0.67|-0.19|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.19|-0.67|0.05
71790287|NCT02057198|143078447|SUPERIORITY||Slope|-0.85||||0.002|TWO_SIDED|95.0|-1.14|-0.57|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.||-0.57|-1.14|0.002
71790288|NCT02057198|143078449|SUPERIORITY|||||||0.48|||||||Chi square (two proportion test)|||||||0.48
71790289|NCT02057198|143078449|SUPERIORITY|||||||0.66|||||||Chi square (two proportion test)|||||||0.66
71838337|NCT05235750|143184203|OTHER||Mean Difference (Net)|-0.3||||0.34|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\] for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for Global QoL (item G7 I am content with the quality of my life right now) as measured by the FACT-G."|||||.34
71790290|NCT01985581|143078450|SUPERIORITY_OR_OTHER||LS mean difference|-3.0||||0.0392|TWO_SIDED|95.0|-5.9|-0.2|||ANOVA|||||-0.2|-5.9|0.0392
71790291|NCT01985581|143078451|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.894|TWO_SIDED|95.0|-4.0|4.6|||ANOVA|||||4.6|-4.0|0.894
71790292|NCT01985581|143078452|SUPERIORITY_OR_OTHER||LS mean difference|-6.2||||0.0001|TWO_SIDED|95.0|-9.1|-3.2|||ANOVA|||||-3.2|-9.1|0.0001
71838338|NCT05235750|143184203|OTHER||Mean Difference (Net)|0.4||||0.27|TWO_SIDED|||||"The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.27
71838339|NCT05235750|143184203|OTHER||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|||||"The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|Mixed Models Analysis||"The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for item Ge6 I worry that my condition will get worse as measured by the FACT-G."|||||.62
71892511|NCT01381094|143306466|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||<0.0001
71892512|NCT01381094|143306466|SUPERIORITY||||||=|0.0422|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Week 6).||||=0.0422
71790293|NCT01985581|143078454|SUPERIORITY_OR_OTHER||LS mean difference|0.3||||0.8706|TWO_SIDED|95.0|-3.2|3.7|||ANOVA|||||3.7|-3.2|0.8706
71790294|NCT03878745|143078458|SUPERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> 0, we can conclude in superiority.|Overall Mean|0.21|||||TWO_SIDED|95.0|0.07|0.35||||||||0.35|0.07|
71790295|NCT03878745|143078459|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.6|1.6||||||||1.6|-1.6|
71790296|NCT03878745|143078460|OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.6|0.1||||||||0.1|-3.6|
71790297|NCT03878745|143078461|SUPERIORITY|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Terumo PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Median Difference (Final Values)|-0.5|||<|0.001|ONE_SIDED|95.0||-0.026|||Mixed Models Analysis|||||-0.026||<0.001
71790298|NCT03878745|143078462|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.2|1.2||||||||1.2|-1.2|
71892513|NCT01381094|143306466|SUPERIORITY||||||=|0.0232|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0232
71672076|NCT03187301|142862355|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|10.9|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|6.1|15.7||||||3 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||15.7|6.1|
71672077|NCT03187301|142862355|NON_INFERIORITY|The hypothesis of assay sensitivity(difference in QTcF time between moxifloxacin and placebo)was evaluated by observing if any of the 4 post-dose evaluation time points had a one-sided(Bonferroni-corrected)95% lower confidence limit which was equal to, or exceeded, 5 msec.|Least Square (LS) Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|4.2|13.8||||||4 hours post-dose: time-matched, baseline-corrected comparison between moxifloxacin and placebo using the ΔΔQTcF approach. The MMRM included region, gender, planned sequence, period, treatment, time, and interaction between treatment and time as fixed factors, and baseline QTcF as a covariate. The patient nested within sequence was included as a random effect.||13.8|4.2|
71672078|NCT02158585|142862363|SUPERIORITY||Mean Difference (Final Values)|8.93||||0.5618|TWO_SIDED|95.0|-3.49|21.35|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between groups in average total number of vertigo attacks||21.35|-3.49|0.5618
71758427|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.62||||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.20|-1.05|0.0041
71758428|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.55|-1.46|<0.0001
71758429|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.5||||0.0353|TWO_SIDED|95.0|-0.96|-0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.03|-0.96|0.0353
71758430|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.85||||0.0011|TWO_SIDED|95.0|-1.35|-0.34|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.34|-1.35|0.0011
71758431|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.5||||0.0582|TWO_SIDED|95.0|-1.01|0.02|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.02|-1.01|0.0582
71758432|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.76||||0.0089|TWO_SIDED|95.0|-1.32|-0.19|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||-0.19|-1.32|0.0089
71758433|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.02||||0.9575|TWO_SIDED|95.0|-0.57|0.61|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.61|-0.57|0.9575
71790299|NCT01172847|143078585|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.91|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||1.05|0.91|
71790300|NCT01172847|143078585|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.95|1.02|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.02|0.95|
71790301|NCT01172847|143078586|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|1.0|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of rimantadine||1.06|1.00|
71672079|NCT02158585|142862364|SUPERIORITY|||||||0.03429|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference between average total number of vertigo attacks in pre-treatment and treatment||||0.03429
71838340|NCT05235750|143184204|OTHER||Mean Difference (Net)|-0.6||||0.76|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for the FACIT-Sp-12 at scale and factor levels, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.76
71838341|NCT05235750|143184204|OTHER||Mean Difference (Net)|-2.1||||0.19|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12.|||||.19
71838342|NCT05235750|143184204|OTHER||Mean Difference (Net)|-1.0||||0.35|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.35
71838343|NCT05235750|143184204|OTHER||Mean Difference (Net)|-1.9||||0.99|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Meaning/Peace factor (M/P) as measured by the FACIT-Sp-12.|||||.99
71838344|NCT05235750|143184204|OTHER||Mean Difference (Net)|0.4||||0.46|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.46
71838345|NCT05235750|143184204|OTHER||Mean Difference (Net)|-0.7||||0.24|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the Faith factor of the FACIT-Sp-12.|||||.24
71790302|NCT01172847|143078587|SUPERIORITY_OR_OTHER||mean exposure ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir||0.96|0.77|
71790303|NCT01172847|143078587|SUPERIORITY_OR_OTHER||mean exposure ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate||1.05|0.92|
71790304|NCT01172847|143078588|SUPERIORITY_OR_OTHER||mean exposure ratio|1.03|||||TWO_SIDED|90.0|0.99|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|mean exposure ratio of rimantadine||1.06|0.99|
71790305|NCT01163279|143078598|SUPERIORITY_OR_OTHER|||||||0.03||||||Statistical analysis applies to post intervention performance category|Chi-squared|||||||0.03
71790306|NCT01163279|143078598|SUPERIORITY_OR_OTHER|||||||0.32||||||Statistical analysis applies to post intervention satisfaction category|Chi-squared|||||||0.32
71790307|NCT01163279|143078598|SUPERIORITY_OR_OTHER|||||||0.54||||||Statistical analysis applies to 3-month follow up performance category|Chi-squared|||||||0.54
71790308|NCT01163279|143078598|SUPERIORITY_OR_OTHER|||||||0.26||||||Statistical analysis applies to 3-month follow up satisfaction category|Chi-squared|||||||0.26
71790309|NCT01163279|143078599|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
71790310|NCT01163279|143078600|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
71790311|NCT01163279|143078601|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
71790312|NCT01163279|143078602|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
71790313|NCT01163279|143078603|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
71790314|NCT01163279|143078603|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
71892514|NCT01381094|143306466|SUPERIORITY||||||=|0.0243|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0243
71892515|NCT01381094|143306466|SUPERIORITY||||||=|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0001
71892516|NCT01381094|143306466|SUPERIORITY||||||=|0.1089|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.1089
71790315|NCT01163279|143078604|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.05
71790316|NCT01163279|143078604|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||>0.05
71790317|NCT01163279|143078605|SUPERIORITY_OR_OTHER||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||<0.1
71672080|NCT02158585|142862365|SUPERIORITY||Mean Difference (Net)|4.57||||0.0092|TWO_SIDED|95.0|0.85|8.29|||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in total average number of vertigo attacks during 3 week time periods||8.29|0.85|0.0092
71758434|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.36||||0.2745|TWO_SIDED|95.0|-1.01|0.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.29|-1.01|0.2745
71758435|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.13||||0.7088|TWO_SIDED|95.0|-0.81|0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.55|-0.81|0.7088
71758436|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.39||||0.3077|TWO_SIDED|95.0|-1.13|0.36|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.36|-1.13|0.3077
71790318|NCT01163279|143078605|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
71790319|NCT01163279|143078606|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||<0.05
71790320|NCT01163279|143078607|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA|||||||>0.05
71790321|NCT01163279|143078607|SUPERIORITY_OR_OTHER||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA|||||||<0.05
71790322|NCT01163279|143078608|SUPERIORITY_OR_OTHER||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA|||||||>0.05
71790323|NCT00546637|143078642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1959||95.0|-0.9|0.2||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (Net) = Least squares mean|The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.||0.2|-0.9|0.1959
71790324|NCT00546637|143078643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0621||95.0|-1.0|0.0||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|||0.0|-1.0|0.0621
71790325|NCT00546637|143078645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0056||95.0|-0.8|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.8|0.0056
71790326|NCT00546637|143078645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.009||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.1|-0.7|0.0090
71790327|NCT00546637|143078646|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0012
71790328|NCT00546637|143078646|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 12||||0.0027
71790329|NCT00546637|143078647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1112||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1112
71790330|NCT00546637|143078647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0855||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.0|-0.3|0.0855
71790331|NCT00546637|143078649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.3847||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.3847
71672081|NCT02158585|142862368|SUPERIORITY||Median Difference (Final Values)|11.14||||0.0385|TWO_SIDED|95.0|-15.64|37.92|||Wilcoxon (Mann-Whitney)|||||37.92|-15.64|0.0385
71672082|NCT04630002|142862410|OTHER||Ratio of geometric least square means|1.137|||||TWO_SIDED|90.0|0.999|1.293|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.293|0.9990|
71758437|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.15||||0.7112|TWO_SIDED|95.0|-0.93|0.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.63|-0.93|0.7112
71790332|NCT00546637|143078649|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.4449||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.4449
71790333|NCT00546637|143078651|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.33||||0.0062||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0062
71790334|NCT00546637|143078651|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.0825||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0825
71790335|NCT00546637|143078652|SUPERIORITY_OR_OTHER|||||||0.0025||95.0||||P-value for median was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4||||0.0025
71790336|NCT00546637|143078653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1748||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.3|0.1748
71790337|NCT00546637|143078653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6572||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.2|-0.1|0.6572
71790338|NCT00546637|143078655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.0051||95.0|-2.9|-0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.5|-2.9|0.0051
71790339|NCT00546637|143078655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1231||95.0|-2.3|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.3|-2.3|0.1231
71758438|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|-0.79||||0.0837|TWO_SIDED|95.0|-1.69|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.11|-1.69|0.0837
71758439|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.08||||0.8655|TWO_SIDED|95.0|-0.88|1.04|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.04|-0.88|0.8655
71758440|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.02||||0.9725|TWO_SIDED|95.0|-1.07|1.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.11|-1.07|0.9725
71758441|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.38||||0.5285|TWO_SIDED|95.0|-0.8|1.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.55|-0.80|0.5285
71758442|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.03||||0.9663|TWO_SIDED|95.0|-1.34|1.4|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.40|-1.34|0.9663
71790340|NCT00546637|143078656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.4||0.3579||95.0|-1.0|0.4||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.4|-1.0|0.3579
71790341|NCT00546637|143078656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9274||95.0|-0.8|0.7||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.8|0.9274
71790342|NCT00546637|143078657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0223||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.1|-0.7|0.0223
71790343|NCT00546637|143078657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1744||95.0|-0.6|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.6|0.1744
71790344|NCT00546637|143078658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7564||95.0|-0.4|0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.5|-0.4|0.7564
71790345|NCT00546637|143078658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.401||95.0|-0.3|0.7||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.7|-0.3|0.4010
71790346|NCT00546637|143078659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1472||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||0.0|-0.2|0.1472
71790347|NCT00546637|143078659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5839||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||0.1|-0.2|0.5839
71790348|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6621||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q1||0.2|-0.1|0.6621
71790349|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.5|-0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q2||-0.2|-0.5|<.0001
71790350|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3242||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q3||0.2|-0.1|0.3242
71790351|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1604||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q4||0.0|-0.3|0.1604
71790352|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4102||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q5||0.1|-0.2|0.4102
71790353|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3079||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q6||0.2|-0.1|0.3079
71790354|NCT00546637|143078660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4066|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q7||0.2|-0.1|0.4066
71790355|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1595||95.0|0.0|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q1||0.3|-0.0|0.1595
71790356|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0614||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q2||0.0|-0.3|0.0614
71790357|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2032||95.0|-0.1|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q3||0.3|-0.1|0.2032
71790358|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0631||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q4||0.0|-0.3|0.0631
71758443|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.01||||0.9914|TWO_SIDED|95.0|-1.61|1.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.63|-1.61|0.9914
71758444|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.22||||0.8345|TWO_SIDED|95.0|-1.85|2.3|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.30|-1.85|0.8345
71790359|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9706||95.0|-0.2|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q5||0.2|-0.2|0.9706
71790360|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8058||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q6||0.2|-0.1|0.8058
71790361|NCT00546637|143078661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3302|TWO_SIDED|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q7||0.2|-0.1|0.3302
71790362|NCT00546637|143078662|SUPERIORITY_OR_OTHER|||||||0.1136||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.1136
71790363|NCT00546637|143078663|SUPERIORITY_OR_OTHER|||||||0.5775||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.5775
71790364|NCT00546637|143078664|SUPERIORITY_OR_OTHER|||||||0.7433||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.7433
71790365|NCT00546637|143078665|SUPERIORITY_OR_OTHER|||||||0.9402||95.0||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.9402
71790366|NCT00546637|143078666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.9||0.004||95.0|-4.5|-0.9||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4||-0.9|-4.5|0.0040
71790367|NCT00546637|143078666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|1.0||0.0068||95.0|-4.8|-0.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12||-0.8|-4.8|0.0068
71790368|NCT00546637|143078667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.9||0.0412||95.0|0.1|3.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||3.6|0.1|0.0412
71790369|NCT00546637|143078667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|1.0||0.1373||95.0|-0.5|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||3.4|-0.5|0.1373
71790370|NCT00546637|143078668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.0941||95.0|-0.3|3.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.8|-0.3|0.0941
71790371|NCT00546637|143078668|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.1||0.2273||95.0|-0.8|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||3.4|-0.8|0.2273
71790372|NCT00546637|143078669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.1||0.0507||95.0|0.0|4.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.3|-0.0|0.0507
71790373|NCT00546637|143078669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.2||0.1136||95.0|-0.4|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12||4.1|-0.4|0.1136
71790374|NCT00546637|143078670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.1||0.0845||95.0|-0.3|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4||4.1|-0.3|0.0845
71790375|NCT00546637|143078670|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.2||0.0662||95.0|-0.2|4.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||4.6|-0.2|0.0662
71838346|NCT05235750|143184204|OTHER||Mean Difference (Net)|-0.4||||0.55|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.55
71838347|NCT05235750|143184204|OTHER||Mean Difference (Net)|-0.9||||0.8|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the revised Faith factor of the FACIT-Sp-12.|||||.80
71838348|NCT05235750|143184204|OTHER||Mean Difference (Net)|-1.5||||0.34|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.34
71790376|NCT00546637|143078671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.9||0.1085||95.0|-0.3|3.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4||3.2|-0.3|0.1085
71790377|NCT00546637|143078671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7685||95.0|-1.6|2.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12||2.1|-1.6|0.7685
71790378|NCT00546637|143078672|SUPERIORITY_OR_OTHER||Median Difference (Net)|6.0||||0.0005||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4||||0.0005
71790379|NCT00546637|143078672|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.0|||<|0.0001||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 8||||<.0001
71790380|NCT00546637|143078672|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.0||||0.0003||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12||||0.0003
71790381|NCT00546637|143078673|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.2251||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|||||0.2251
71790382|NCT03274440|143078676|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction effect between condition and time (includes all three groups and all time points)||||.577
71790383|NCT03274440|143078676|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=10.50; df=6, 10||Test for main effect of time (includes all three groups and all time points)||||<.001
71790384|NCT03274440|143078676|OTHER|A random-effects linear mixed model evaluated changes in YBOCCS as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.72|||||||Linear mixed effects regression|||Test for main effect of condition (includes all three groups and all time points)||||.72
71790385|NCT03274440|143078677|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.577|||||||Linear mixed effects regression|||Test for interaction between condition and time||||.577
71790386|NCT03274440|143078677|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.|||||<|0.001|||||||Linear mixed effects regression|F=7.00, df=6,10||Test for main effect of time||||<.001
71790387|NCT03274440|143078677|OTHER|A random-effects linear mixed model evaluated changes in STAI-S as a function of condition (THC, CBD, placebo \[PBO\]), time point, and their interaction.||||||0.002|||||||Linear mixed effects regression|F=6.26, df=2, 10||Test for main effect of condition||||.002
71790388|NCT01074450|143078678|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|100.93|||||TWO_SIDED|90.0|94.23|108.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.1|94.23|
71790389|NCT01074450|143078679|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.71|||||TWO_SIDED|90.0|99.74|109.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.92|99.74|
71790390|NCT01074450|143078680|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|104.15|||||TWO_SIDED|90.0|99.05|109.52|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.52|99.05|
71892517|NCT01381094|143306466|SUPERIORITY||||||=|0.0833|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||p-value was based on the comparison within treatment group (Change from Baseline to Follow-up).||||=0.0833
71790391|NCT04984993|143078681|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 0 versus alternative hypothesis: mu \>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.||||<0.001
71790392|NCT04984993|143078682|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.||||<0.001
71790393|NCT04984993|143078682|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.||||<0.001
71790394|NCT04984993|143078682|OTHER|||||||0.89||||||Significance level of 0.025|t-test, 1 sided|||Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.||||0.890
71790395|NCT04984993|143078683|OTHER||||||<|0.001||||||Significance level of 0.025|t-test, 1 sided|||||||<0.001
71790396|NCT04984993|143078683|OTHER|||||||0.3327||||||Significance level of 0.025|t-test, 1 sided|||||||0.3327
71838349|NCT05235750|143184204|OTHER||Mean Difference (Net)|-3.0||||0.91|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for the total FACIT-Sp-12 (revised).|||||.91
71790397|NCT04984993|143078683|OTHER||||||>|0.999||||||Significance level of 0.025|t-test, 1 sided|||||||>0.999
71790398|NCT02865187|143078686|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|7.0||0.71|TWO_SIDED|95.0|-7.4|5.1||a priori threshold for significance was set at p\<0.05|t-test, 2 sided|||||5.1|-7.4|0.71
71790399|NCT02865187|143078687|SUPERIORITY||Chi square|0.0||||1|TWO_SIDED|||||a priori threshold for significance was set at p\< 0.05.|Chi-squared|||||||1.00
71790400|NCT00385996|143078736|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Binomial distribution|Binomial distribution and test proportion =0.50||One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.||||<0.01
71790401|NCT00385996|143078738|OTHER||TTP [% without disease at 24 months]|63.6|||||TWO_SIDED|95.0|43.4|83.8|||||Using the Kaplan-Meier method.|One arm study||83.8|43.4|
71790402|NCT00385996|143078739|OTHER||% alive without disease at 25 months|72.7|||||TWO_SIDED|95.0|54.1|91.3|||||Using the Kaplan-Meier method.|One arm study||91.3|54.1|
71790403|NCT04249310|143078740|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.32|2.46|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox-regression was used to estimate the hazard ratios and 95% confidence intervals.|||2.46|0.32|
71790404|NCT04249310|143078741|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.15|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate or Severe COPD Exacerbation||1.15|0.63|
71790405|NCT04249310|143078741|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.43|1.01|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Moderate COPD Exacerbation||1.01|0.43|
71790406|NCT04249310|143078741|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.31|||||\[(Tiotropium/Olodaterol) / Tiotropium\] Cox regression was used to estimate the hazard ratios and 95% confidence intervals.|Severe COPD Exacerbation||1.31|0.62|
71790407|NCT00597766|143078786|SUPERIORITY_OR_OTHER||GroupXtime interaction|-0.17||||0.16|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16|Linear mixed model|1st order antedependence covariance structure||"Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.16
71790408|NCT00597766|143078786|SUPERIORITY_OR_OTHER||group x time interaction|-0.04||||0.77|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77|linear mixed model|first order antedependent covariance structure||"Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."||||0.77
71790409|NCT00597766|143078787|SUPERIORITY_OR_OTHER||group x time interaction|-0.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2|Linear mixed model|first order antedpendent covariance structure||This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
71790410|NCT00597766|143078787|SUPERIORITY_OR_OTHER||group x time interaction|-0.02||||0.9|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9|linear mixed model|1st order antedependence covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.9
71892518|NCT01381094|143306468|SUPERIORITY||||||=|0.5456|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.5456
71892519|NCT01381094|143306468|SUPERIORITY||||||=|0.0053|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0053
71790411|NCT00597766|143078788|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.3||||0.2|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2|linear mixed model|unstructured covariance structure||The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.2
71790412|NCT00597766|143078788|SUPERIORITY_OR_OTHER||Groupxtime interaction|1.1||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3|linear mixed model|Unstructured covariance structure||Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
71790413|NCT00597766|143078789|SUPERIORITY_OR_OTHER||group x time interaction|0.4||||0.8|TWO_SIDED|95.0||||Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8|linear mixed model|first order antedepentent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.8
71790414|NCT00597766|143078789|SUPERIORITY_OR_OTHER||group x time interaction|1.7||||0.3|TWO_SIDED|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3|linear mixed model|first order antedependent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.||||0.3
71790415|NCT00840294|143078807|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71790416|NCT00969150|143078836|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.49||||0.2492|TWO_SIDED|95.0|-4.02|1.05|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.05|-4.02|0.2492
71790417|NCT00969150|143078837|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.54||||0.5625|TWO_SIDED|95.0|-2.38|1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||1.29|-2.38|0.5625
71790418|NCT00883116|143078852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.0397|TWO_SIDED|95.0|1.0|1.7|||Log Rank|||||1.7|1.0|0.0397
71790419|NCT00883116|143078853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.8011|TWO_SIDED|95.0|0.8|1.3|||Log Rank|||||1.3|0.8|0.8011
71790420|NCT03060447|143078896|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 2||||0.55
71790421|NCT03060447|143078896|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 1: Day 8||||0.54
71790422|NCT03060447|143078896|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 1||||0.54
71790423|NCT03060447|143078896|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 2: Day 8||||0.54
71790424|NCT03060447|143078896|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 1||||0.54
71790425|NCT03060447|143078896|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 3: Day 8||||0.57
71790426|NCT03060447|143078896|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 1||||0.54
71790427|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 2||||0.52
71790428|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 4||||0.52
71790429|NCT03060447|143078896|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 4: Day 8||||0.61
71790430|NCT03060447|143078896|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 1||||0.54
71892520|NCT01381094|143306468|SUPERIORITY||||||<|0.0001|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||<0.0001
71892521|NCT01381094|143306468|SUPERIORITY||||||=|0.004|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.0040
71790431|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 5: Day 8||||0.52
71790432|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 1||||0.52
71790433|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 6: Day 4||||0.52
71790434|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 6: Day 8||||0.52
71790435|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7: Day 1||||0.52
71790436|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 7 - Day 8||||0.52
71790437|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 1||||0.52
71790438|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 8: Day 8||||0.52
71672083|NCT04630002|142862411|OTHER||Ratio of geometric least square means|1.068|||||TWO_SIDED|90.0|0.9185|1.242|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.242|0.9185|
71672084|NCT04630002|142862412|OTHER||Ratio of geometric least square means|0.9891|||||TWO_SIDED|90.0|0.9313|1.051|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.051|0.9313|
71672085|NCT04630002|142862413|OTHER||Ratio of geometric least square means|1.05|||||TWO_SIDED|90.0|0.9816|1.122|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.122|0.9816|
71672086|NCT04630002|142862414|OTHER||Ratio of geometric least square means|1.102|||||TWO_SIDED|90.0|1.025|1.185|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.185|1.025|
71672087|NCT04630002|142862415|OTHER||Ratio of geometric least square means|1.12|||||TWO_SIDED|90.0|0.9947|1.26|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.260|0.9947|
71672088|NCT04630002|142862416|OTHER||Ratio of geometric least square means|0.5299|||||TWO_SIDED|90.0|0.4801|0.5848|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||0.5848|0.4801|
71672089|NCT04630002|142862417|OTHER||Ratio of geometric least square means|0.6001|||||TWO_SIDED|90.0|0.5271|0.6833|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||0.6833|0.5271|
71790439|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 9: Day 1||||0.52
71790440|NCT03060447|143078896|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 9: Day 8||||1.00
71790441|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests||Dose 10: Day 1||||0.52
71790442|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 2||||0.52
71892522|NCT01381094|143306468|SUPERIORITY||||||=|0.2017|||||||2 sided t-test/Wilcoxon Signed-rank Test|The comparison was made by using a 2-tailed, paired t-test (if the distribution was normal) or Wilcoxon Signed-Rank Test otherwise with an α=0.05.||||||=0.2017
71672090|NCT04630002|142862418|OTHER||Ratio of geometric least square means|1.144|||||TWO_SIDED|90.0|1.082|1.21|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.210|1.082|
71672091|NCT04630002|142862419|OTHER||Ratio of geometric least square means|1.104|||||TWO_SIDED|90.0|1.026|1.187|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.187|1.026|
71672092|NCT04630002|142862420|OTHER||Ratio of geometric least square means|0.9435|||||TWO_SIDED|90.0|0.8147|1.093|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter AUC(0-tau).|||1.093|0.8147|
71672093|NCT04630002|142862421|OTHER||Ratio of geometric least square means|0.8928|||||TWO_SIDED|90.0|0.7467|1.068|||||A linear mixed-effects model with period as a fixed effect, participant as a random effect, and measurements within participant as repeated measures was performed on the log-transformed parameter Cmax.|||1.068|0.7467|
71672094|NCT02375971|142862469|SUPERIORITY|The primary efficacy variable was treatment success, defined as the absence of active ROP and absence of unfavorable structural outcomes in both eyes 24 weeks after starting study treatment.|Odds Ratio (OR)|2.19||||0.0254|TWO_SIDED|95.0|0.9932|4.8235|||Cochran-Mantel-Haenszel|||||4.8235|0.9932|0.0254
71672095|NCT01011816|142862494|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX||||0.52
71672096|NCT00343044|142862507|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Planned enrollment of 40 patients was determined assuming a median progression free survival (PFS) of 9 months (based on a median PFS of 7.2 months for low-dose, metronomic cyclophosphamide plus bevacizumab in a phase 2 study) and an analysis calculating the sample size at which the narrowing of its 95% confidence interval (CI) became greater than .2 for every 2 patients added. Progression free survival was estimated using the Kaplan-Meier method.||||.08
71790443|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 4||||0.52
71790444|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 8||||0.52
71790445|NCT03060447|143078896|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||Dose 10: Day 14||||0.52
71790446|NCT03060447|143078897|SUPERIORITY|||||||0.035|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 50 Copies/mL||||0.035
71790447|NCT03060447|143078897|SUPERIORITY|||||||0.024|||||||Log Rank|P-value between treatment groups was based on log-rank test.||≥ 200 Copies/mL||||0.024
71790448|NCT03060447|143078898|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.67
71790449|NCT03060447|143078899|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|P-values between treatment groups were based on Wilcoxon rank sum test.||||||0.78
71790450|NCT03060447|143078900|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Baseline||||0.34
71672097|NCT00343044|142862508|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Overall survival(OS)was estimated using the Kaplan-Meier method.||||.02
71672098|NCT03175536|142862531|SUPERIORITY||Mean Difference (Net)|3.4||||0.05|TWO_SIDED|95.0|-5.2|12.1|||GEE models|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||12.1|-5.2|0.05
71672099|NCT03175536|142862532|SUPERIORITY||Mean Difference (Net)|1.3||||0.05|TWO_SIDED|95.0|-4.4|7.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||7.0|-4.4|0.05
71672100|NCT03175536|142862533|SUPERIORITY||Mean Difference (Net)|6.0||||0.05|TWO_SIDED|95.0|0.7|11.3|||GEE model|Binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||11.3|0.7|0.05
71672101|NCT03175536|142862534|SUPERIORITY||Mean Difference (Net)|0.16||||0.05|TWO_SIDED|95.0|-0.74|1.06|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes|||1.06|-0.74|0.05
71790451|NCT03060447|143078900|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 2||||0.11
71790452|NCT03060447|143078900|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 1: Day 8||||0.81
71790453|NCT03060447|143078900|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 1||||0.83
71790454|NCT03060447|143078900|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 2||||0.12
71672102|NCT03175536|142862535|SUPERIORITY||Median Difference (Net)|-34.0||||0.05|TWO_SIDED|95.0|-47.0|-21.0|||GEE model|Negative binomial regression with GEE model; term of interest was interaction between study group and time period (baseline vs follow-up year).|Using terms from the regression model, we applied marginal effects methods to calculate mean adjusted baseline and follow-up PDC and absolute changes.|||-21|-47|0.05
71672103|NCT00442897|142862550|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.714||||||95.0|1.77|7.78|||||Odds ratio was adjusted by baseline LDL strata.|||7.78|1.77|
71672104|NCT00442897|142862551|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.579||||||95.0|1.32|5.06|||||Odds ratio was adjusted by baseline LDL strata.|||5.06|1.32|
71672105|NCT04498182|142862552|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
71672106|NCT04498182|142862552|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
71672107|NCT04498182|142862553|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
71672108|NCT04498182|142862553|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
71672109|NCT04498182|142862554|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|2.81||0.2305|TWO_SIDED|95.0|-8.9|2.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.2|-8.9|0.2305
71672110|NCT04498182|142862554|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.81||0.7436|TWO_SIDED|95.0|-4.6|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-4.6|0.7436
71672111|NCT04498182|142862555|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
71672112|NCT04498182|142862555|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
71790455|NCT03060447|143078900|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 4: Day 8||||0.45
71790456|NCT03060447|143078900|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 1||||0.25
71790457|NCT03060447|143078900|SUPERIORITY|||||||0.053|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 2||||0.053
71790458|NCT03060447|143078900|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, Dose 10: Day 8||||0.16
71790459|NCT03060447|143078900|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IFN-a, ATI Remission Visit||||0.27
71790460|NCT03060447|143078900|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Baseline||||0.35
71790461|NCT03060447|143078900|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 2||||0.013
71672113|NCT04498182|142862556|SUPERIORITY||LS Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|3.17||0.0281|TWO_SIDED|95.0|-13.2|-0.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.8|-13.2|0.0281
71838350|NCT05235750|143184205|OTHER||Mean Difference (Net)|1.1||||0.14|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|We analyzed short- (at 6 weeks post-baseline, T3) and longer-term differences (at 8 weeks post-baseline, T4) for two subscales HADS-A and HADS-D respectively, expecting a larger size of differences at T3. The short-term difference \[(T3-T2)-(T2-T1)\] represents differences between post-intervention change (T3-T2) and pre-intervention change (T2-T1). Longer-term difference \[(T4-T2)-(T2-T1)\] represents differences between 2 weeks post-intervention change (T4-T2) and pre-intervention change (T2-T1).||||.14
71838351|NCT05235750|143184205|OTHER||Mean Difference (Net)|1.2||||0.14|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-anxiety subscale (HADS-A).|||||.14
71838352|NCT05235750|143184205|OTHER||Median Difference (Net)|0.6||||0.32|TWO_SIDED|||||The above p value refers to the difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between post-intervention change and pre-intervention change (or \[(T3-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.32
71838353|NCT05235750|143184205|OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|||||The above p value refers to the difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|Mixed Models Analysis||The above value represents net difference between 2 weeks post-intervention change and pre-intervention change (or \[(T4-T2)-(T2-T1)\]) for HADS-depression subscale (HADS-D).|||||.20
71838354|NCT02301910|143184211|NON_INFERIORITY|The calculation was carried out taking into account the power of 80%||||||0.87|||||||ANOVA|||||||0.87
71838355|NCT04282148|143184220|SUPERIORITY||||||<|0.0001|||||||Z test using Kaplan Meier survival estim|||||||<0.0001
71838356|NCT04770532|143184241|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin degludec) was strictly below 0.3%.|Treatment difference|-0.22|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.08|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||-0.08|-0.37|<0.0001
71790462|NCT03060447|143078900|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 1: Day 8||||0.15
71790463|NCT03060447|143078900|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 1||||0.30
71672114|NCT04498182|142862556|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|3.18||0.9186|TWO_SIDED|95.0|-5.9|6.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.6|-5.9|0.9186
71790464|NCT03060447|143078900|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 2||||0.003
71838357|NCT04938492|143184252|SUPERIORITY||Slope|2.08|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
71838358|NCT04938492|143184253|SUPERIORITY||Slope|0.19|||<|0.001|TWO_SIDED||||||Latent growth modeling|||||||<.001
71838359|NCT04938492|143184254|SUPERIORITY||Slope|0.22|||<|0.01|TWO_SIDED||||||Latent growth modeling|||||||<.01
71838360|NCT04938492|143184255|SUPERIORITY||Slope|0.23|||>|0.05|TWO_SIDED||||||Latent growth modeling|||||||>.05
71838361|NCT02876588|143184312|SUPERIORITY||Odds Ratio (OR)|1.03||||0.6|TWO_SIDED|95.0|0.9|1.2||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, and the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.20|.90|.60
71838362|NCT02876588|143184313|SUPERIORITY||Odds Ratio (OR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.19||Random-effects logistic regression models were constructed, using RAR order sessions as the outcome, randomization group as the independent variable, the clinician as the random intercept to account for nesting of order sessions within clinicians|Regression, Logistic|||||1.19|.89|.68
71790465|NCT03060447|143078900|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 4: Day 8||||0.49
71790466|NCT03060447|143078900|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 1||||0.25
71790467|NCT03060447|143078900|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 2||||0.055
71790468|NCT03060447|143078900|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, Dose 10: Day 8||||0.90
71838363|NCT02876588|143184314|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71838364|NCT02143726|143184364|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0918|TWO_SIDED|95.0|0.23|1.33|||Log Rank|Stratified 1-sided log-rank test (stratified by ECOG performance status, prior systemic treatment for hürthle thyroid cancer, and treating site).||||1.33|0.23|0.0918
71838365|NCT02143726|143184366|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.3976|TWO_SIDED|95.0|0.53|4.96|||Log Rank|||||4.96|0.53|0.3976
71838366|NCT03158714|143184446|SUPERIORITY||Mean Difference (Net)|0.033||||0.005|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.005
71790469|NCT03060447|143078900|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IL-1RA, ATI Remission Visit||||0.39
71790470|NCT03060447|143078900|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Baseline||||0.75
71790471|NCT03060447|143078900|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 2||||<0.001
71672115|NCT04498182|142862557|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
71790472|NCT03060447|143078900|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 1: Day 8||||0.69
71790473|NCT03060447|143078900|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 1||||0.15
71790474|NCT03060447|143078900|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 2||||0.018
71790475|NCT03060447|143078900|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 4: Day 8||||0.030
71790476|NCT03060447|143078900|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 1||||0.087
71790477|NCT03060447|143078900|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 2||||<0.001
71790478|NCT03060447|143078900|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, Dose 10: Day 8||||0.066
71790479|NCT03060447|143078900|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||IP-10, ATI Remission||||0.86
71790480|NCT03060447|143078900|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Baseline||||0.19
71790481|NCT03060447|143078900|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 2||||0.021
71790482|NCT03060447|143078900|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 1: Day 8||||0.31
71790483|NCT03060447|143078900|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 1||||0.10
71790484|NCT03060447|143078900|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 2||||0.018
71790485|NCT03060447|143078900|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 4: Day 8||||0.69
71790486|NCT03060447|143078900|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 1||||0.46
71790487|NCT03060447|143078900|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 2||||0.21
71790488|NCT03060447|143078900|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, Dose 10: Day 8||||0.67
71790489|NCT03060447|143078900|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ITAC, ATI Remission||||0.60
71790490|NCT03060447|143078901|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 1: Day 2||||0.002
71790491|NCT03060447|143078901|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 1||||0.58
71790492|NCT03060447|143078901|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 4: Day 2||||0.009
71790493|NCT03060447|143078901|SUPERIORITY|ISG15, Dose 10: Day 1||||||0.031|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.031
71790494|NCT03060447|143078901|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||ISG15, Dose 10: Day 2||||0.001
71790495|NCT03060447|143078901|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 1: Day 2||||0.003
71790496|NCT03060447|143078901|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 1||||0.057
71790497|NCT03060447|143078901|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 4: Day 2||||0.009
71790498|NCT03060447|143078901|SUPERIORITY|||||||0.057|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 1||||0.057
71790499|NCT03060447|143078901|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||OAS-1, Dose 10: Day 2||||0.005
71790500|NCT03060447|143078901|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 1: Day 2||||<0.001
71672116|NCT04498182|142862557|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
71672117|NCT04498182|142862558|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.75||0.9846|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.5|-1.5|0.9846
71672118|NCT04498182|142862558|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6508|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.8|-1.1|0.6508
71672119|NCT04498182|142862559|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4936|TWO_SIDED|95.0|-1.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-1.9|0.4936
71672120|NCT04498182|142862559|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.7131|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.6|-1.1|0.7131
71672121|NCT04498182|142862560|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
71790501|NCT03060447|143078901|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 1||||0.17
71790502|NCT03060447|143078901|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 4: Day 2||||0.003
71672122|NCT04498182|142862560|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
71672123|NCT04498182|142862561|SUPERIORITY||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.38||0.0786|TWO_SIDED|95.0|-12.6|0.7|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.7|-12.6|0.0786
71672124|NCT04498182|142862561|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.39||0.9477|TWO_SIDED|95.0|-6.9|6.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.5|-6.9|0.9477
71672125|NCT04498182|142862562|SUPERIORITY||LS Means Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
71672126|NCT04498182|142862562|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
71672127|NCT04498182|142862563|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|3.16||0.1153|TWO_SIDED|95.0|-11.2|1.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.2|-11.2|0.1153
71672128|NCT04498182|142862563|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|3.15||0.9975|TWO_SIDED|95.0|-6.2|6.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.2|-6.2|0.9975
71672129|NCT04498182|142862564|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
71672130|NCT04498182|142862564|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
71672131|NCT04498182|142862565|SUPERIORITY||LS Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|3.82||0.1518|TWO_SIDED|95.0|-13.0|2.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||2.0|-13.0|0.1518
71672132|NCT04498182|142862565|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.87||0.407|TWO_SIDED|95.0|-4.4|10.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||10.8|-4.4|0.4070
71790503|NCT03060447|143078901|SUPERIORITY|MX1, Dose 10: Day 1||||||0.1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.100
71672133|NCT04498182|142862566|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
71672134|NCT04498182|142862566|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
71672135|NCT04498182|142862567|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.56||0.756|TWO_SIDED|95.0|-8.1|5.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.9|-8.1|0.7560
71672136|NCT04498182|142862567|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|3.62||0.8308|TWO_SIDED|95.0|-7.9|6.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||6.4|-7.9|0.8308
71790504|NCT03060447|143078901|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||MX1, Dose 10: Day 2||||<0.001
71790505|NCT03060447|143078902|SUPERIORITY|||||||0.7469|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Baseline||||0.7469
71790506|NCT03060447|143078902|SUPERIORITY|||||||0.1207|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 1||||0.1207
71790507|NCT03060447|143078902|SUPERIORITY|||||||0.4113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 2||||0.4113
71790508|NCT03060447|143078902|SUPERIORITY|||||||0.1113|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 4: Day 4||||0.1113
71790509|NCT03060447|143078902|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 1||||0.2410
71672137|NCT04498182|142862568|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
71672138|NCT04498182|142862568|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
71672139|NCT04498182|142862569|SUPERIORITY||LS Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|2.26||0.0005|TWO_SIDED|95.0|-12.4|-3.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.5|-12.4|0.0005
71672140|NCT04498182|142862569|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|2.26||0.0585|TWO_SIDED|95.0|-8.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.2|-8.7|0.0585
71790510|NCT03060447|143078902|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 6: Day 4||||0.1098
71790511|NCT03060447|143078902|SUPERIORITY|||||||0.0369|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 1||||0.0369
71672141|NCT04498182|142862570|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
71672142|NCT04498182|142862570|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
71672143|NCT04498182|142862571|SUPERIORITY||LS Mean Difference|-8.9|STANDARD_ERROR_OF_MEAN|2.77||0.0015|TWO_SIDED|95.0|-14.3|-3.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-3.4|-14.3|0.0015
71672144|NCT04498182|142862571|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.78||0.6812|TWO_SIDED|95.0|-6.6|4.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.3|-6.6|0.6812
71672145|NCT04498182|142862572|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
71672146|NCT04498182|142862572|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
71672147|NCT04498182|142862573|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.5||0.152|TWO_SIDED|95.0|-8.5|1.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||1.3|-8.5|0.1520
71672148|NCT04498182|142862573|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.49||0.8515|TWO_SIDED|95.0|-5.4|4.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.4|-5.4|0.8515
71672149|NCT04498182|142862574|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
71790512|NCT03060447|143078902|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 2||||0.0814
71790513|NCT03060447|143078902|SUPERIORITY|||||||0.1658|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 4||||0.1658
71790514|NCT03060447|143078902|SUPERIORITY|||||||0.9431|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD4/CD38/HLADR, Dose 10: Day 14||||0.9431
71790515|NCT03060447|143078902|SUPERIORITY|||||||0.6514|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Baseline||||0.6514
71790516|NCT03060447|143078902|SUPERIORITY|||||||0.0821|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 1||||0.0821
71790517|NCT03060447|143078902|SUPERIORITY|||||||0.2353|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 2||||0.2353
71790518|NCT03060447|143078902|SUPERIORITY|||||||0.1779|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 4: Day 4||||0.1779
71790519|NCT03060447|143078902|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 1||||0.7491
71790520|NCT03060447|143078902|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 6: Day 4||||0.0700
71790521|NCT03060447|143078902|SUPERIORITY|||||||0.3711|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 1||||0.3711
71790522|NCT03060447|143078902|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 2||||0.0814
71790523|NCT03060447|143078902|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 4||||0.0700
71790524|NCT03060447|143078902|SUPERIORITY|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD8/CD38/HLADR, Dose 10: Day 14||||0.8303
71790525|NCT03060447|143078902|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Baseline||||0.9530
71790526|NCT03060447|143078902|SUPERIORITY|||||||0.1735|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 1||||0.1735
71790527|NCT03060447|143078902|SUPERIORITY|||||||0.2971|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 2||||0.2971
71790528|NCT03060447|143078902|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 4: Day 4||||1.0000
71790529|NCT03060447|143078902|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 1||||1.0000
71790530|NCT03060447|143078902|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 6: Day 4||||0.3374
71790531|NCT03060447|143078902|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 1||||0.7656
71790532|NCT03060447|143078902|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 2||||0.0814
71790533|NCT03060447|143078902|SUPERIORITY|||||||0.3374|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 4||||0.3374
71790534|NCT03060447|143078902|SUPERIORITY|||||||0.432|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56+CD16+, Dose 10: Day 14||||0.4320
71790535|NCT03060447|143078902|SUPERIORITY|||||||0.8597|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Baseline||||0.8597
71790536|NCT03060447|143078902|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 1||||1.0000
71892523|NCT00486902|143306484|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Fisher Exact|||Sample size was determined assuming an incidence of breakthrough pain of 75% and an absolute difference between groups of -20 to +15%. This rate of request for analgesia in the first 24 h was based on data from a parallel study utilizing the same multimodal postoperative pain regimen for cesarean delivery. Group sample sizes of 90 achieve 80% power to detect this difference using the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.05.||||0.86
71892524|NCT00486902|143306485|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
71790537|NCT03060447|143078902|SUPERIORITY|||||||0.0306|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 2||||0.0306
71790538|NCT03060447|143078902|SUPERIORITY|||||||0.8345|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 4: Day 4||||0.8345
71790539|NCT03060447|143078902|SUPERIORITY|||||||0.9151|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 1||||0.9151
71790540|NCT03060447|143078902|SUPERIORITY|||||||0.1098|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 6: Day 4||||0.1098
71790541|NCT03060447|143078902|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 1||||1.0000
71790542|NCT03060447|143078902|SUPERIORITY|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 2||||0.0814
71790543|NCT03060447|143078902|SUPERIORITY|||||||0.4555|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 4||||0.4555
71790544|NCT03060447|143078902|SUPERIORITY|||||||0.6171|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56dimCD16neg, Dose 10: Day 14||||0.6171
71790545|NCT03060447|143078902|SUPERIORITY|||||||0.0677|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Baseline||||0.0677
71790546|NCT03060447|143078902|SUPERIORITY|||||||0.4712|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 1||||0.4712
71790547|NCT03060447|143078902|SUPERIORITY|||||||0.6889|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 2||||0.6889
71790548|NCT03060447|143078902|SUPERIORITY|||||||0.1437|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 4: Day 4||||0.1437
71790549|NCT03060447|143078902|SUPERIORITY|||||||0.7491|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 1||||0.7491
71790550|NCT03060447|143078902|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 6: Day 4||||0.0700
71790551|NCT03060447|143078902|SUPERIORITY|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 1||||0.7656
71790552|NCT03060447|143078902|SUPERIORITY|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 2||||0.1752
71790553|NCT03060447|143078902|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||CD69+CD56brCD16dim, Dose 10: Day 4||||0.0700
71790554|NCT03060447|143078902|SUPERIORITY|CD69+CD56brCD16dim, Dose 10: Day 14||||||0.2246|||||||Wilcoxon (Mann-Whitney)|P-values are based on two-sided Wilcoxon rank sum tests.||||||0.2246
71790555|NCT02733991|143078928|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.25|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-2.25|-3.51|<0.0001
71790556|NCT02733991|143078929|SUPERIORITY||Mean Difference (Final Values)|-42.62|||<|0.0001|TWO_SIDED|95.0|-52.01|-33.19|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm|||-33.19|-52.01|<0.0001
71790557|NCT02733991|143078930|NON_INFERIORITY|Non-inferiority margin of 40 min/day|Mean Difference (Final Values)|-38.8|||||ONE_SIDED|97.5||-0.46|||||Model based Estimated mean; difference = control arm - treatment arm|||-0.46||
71790558|NCT02733991|143078930|SUPERIORITY||Mean Difference (Final Values)|38.8||||0.0474|TWO_SIDED|95.0|0.46|77.11|||Mixed Models Analysis||Model based Estimated mean; Difference = Treatment arm - Control arm|||77.11|0.46|0.0474
71790559|NCT02612428|143078933|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.762|TWO_SIDED|95.0|0.509|1.64|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.||1.640|0.509|0.762
71790560|NCT02612428|143078934|SUPERIORITY|||||||0.6829|||||||Chi-squared|||||||0.6829
71790561|NCT02612428|143078935|SUPERIORITY|||||||0.048|||||||Chi-squared|||||||0.048
71790562|NCT01928329|143078936|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.0816|TWO_SIDED|95.0|-0.5|0.03||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.03|-0.50|0.0816
71790563|NCT01928329|143078937|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.912|TWO_SIDED|95.0|-0.28|0.25||The \<0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).||||0.25|-0.28|0.912
71790564|NCT01928329|143078938|SUPERIORITY||Z score|-0.801||||0.423|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.423
71790565|NCT01928329|143078939|SUPERIORITY||Z score|-1.312||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.189
71790566|NCT05167734|143078946|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.02|TWO_SIDED|95.0|0.1|1.2|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|values greater than 0 infer higher hemoglobin in active intervention|||1.2|0.1|0.02
71790567|NCT05167734|143078947|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.0|1.1|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|adjusted mean difference|3-months post hospitalization||1.1|0.0|0.04
71790568|NCT05167734|143078947|SUPERIORITY||Mean Difference (Net)|0.2||||0.42|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|linear mixed effects model adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission||Hospital Discharge||0.7|-0.3|0.42
71790569|NCT05167734|143078948|SUPERIORITY|||||||0.352|||||||Mixed Models Analysis|||||||0.352
71790570|NCT05167734|143078949|SUPERIORITY||||||<|0.001||||||threshold for significance - p\<0.05|Mixed Models Analysis|||||||<0.001
71790571|NCT05167734|143078950|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.44|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital Discharge||2.40|0.44|0.94
71838367|NCT03158714|143184446|SUPERIORITY||Mean Difference (Net)|0.02||||0.101|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.101
71838368|NCT03158714|143184447|SUPERIORITY||Mean Difference (Net)|3.96|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
71790572|NCT05167734|143078950|SUPERIORITY||Odds Ratio (OR)|1.79||||0.18|TWO_SIDED|95.0|0.76|4.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||4.20|0.76|0.18
71790573|NCT05167734|143078950|SUPERIORITY||Odds Ratio (OR)|1.23||||0.64|TWO_SIDED|95.0|0.51|3.0|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||3.00|0.51|0.64
71790574|NCT05167734|143078951|SUPERIORITY||Odds Ratio (OR)|1.81||||0.23|TWO_SIDED|95.0|0.68|4.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|Hospital discharge||4.80|0.68|0.23
71790575|NCT05167734|143078951|SUPERIORITY||Odds Ratio (OR)|2.43||||0.09|TWO_SIDED|95.0|0.87|6.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||6.80|0.87|0.09
71838369|NCT03158714|143184447|SUPERIORITY||Mean Difference (Net)|4.09|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Regression, Linear|Utilized multi-level modeling to account for nested data (individuals within couples), and controlled for baseline levels of outcome in regression.||||||< .001
71838370|NCT03158714|143184448|SUPERIORITY||Mean Difference (Net)|0.343||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.003
71790576|NCT05167734|143078951|SUPERIORITY||Odds Ratio (OR)|2.52||||0.084|TWO_SIDED|95.0|0.88|7.2|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||7.20|0.88|0.084
71790577|NCT05167734|143078952|SUPERIORITY||Mean Difference (Net)|218.0||||0.13|TWO_SIDED|95.0|-73.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, and baseline ADLs|scores greater than 0 reflect greater ambulatory distance in active intervention|1-month post hospitalization||510|-73|0.13
71790578|NCT05167734|143078952|SUPERIORITY||Median Difference (Net)|178.0||||0.27|TWO_SIDED|95.0|-154.0|510.0|||Mixed Models Analysis|adjusting for baseline hemoglobin, age, sex, surgical vs. non-surgical admission, baseline ADLs||3-months post hospitalization||510|-154|0.27
71790579|NCT05167734|143078953|SUPERIORITY||Odds Ratio (OR)|2.49||||0.12|TWO_SIDED|95.0|0.79|7.8|||proportional odds|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||7.80|0.79|0.12
71790580|NCT05167734|143078953|SUPERIORITY||Odds Ratio (OR)|3.1||||0.07|TWO_SIDED|95.0|0.91|10.5|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||10.5|0.91|0.07
71892525|NCT00486902|143306486|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
71838371|NCT03158714|143184448|SUPERIORITY||Mean Difference (Net)|0.172||||0.152|TWO_SIDED|||||The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Utilized multi-level modeling to account for nested data (individuals within couples), and accounted for time within individual.||||||.152
71672150|NCT04498182|142862574|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
71790581|NCT05167734|143078954|SUPERIORITY||Odds Ratio (OR)|0.5||||0.29|TWO_SIDED|95.0|0.14|1.8|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for anxiety score||1.80|0.14|0.29
71790582|NCT05167734|143078954|SUPERIORITY||Odds Ratio (OR)|0.68||||0.57|TWO_SIDED|95.0|0.18|2.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for anxiety score||2.60|0.18|0.57
71790583|NCT05167734|143078954|SUPERIORITY||Odds Ratio (OR)|0.36||||0.12|TWO_SIDED|95.0|0.1|1.3|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization for depression score||1.30|0.10|0.12
71790584|NCT05167734|143078954|SUPERIORITY||Odds Ratio (OR)|0.62||||0.48|TWO_SIDED|95.0|0.16|2.4|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization for depression score||2.40|0.16|0.48
71790585|NCT05167734|143078955|SUPERIORITY||Odds Ratio (OR)|1.48||||0.56|TWO_SIDED|95.0|0.39|5.6|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|1-month post hospitalization||5.60|0.39|0.56
71790586|NCT05167734|143078955|SUPERIORITY||Odds Ratio (OR)|9.16||||0.02|TWO_SIDED|95.0|1.4|59.9|||proportional odds|proportional odds models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|3-months post hospitalization||59.9|1.40|0.02
71790587|NCT05167734|143078956|SUPERIORITY||Odds Ratio (OR)|0.16||||0.09|TWO_SIDED|95.0|0.02|1.4|||Regression, Logistic|adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds of higher value/score associated with active intervention|||1.40|0.02|0.09
71790588|NCT05167734|143078958|SUPERIORITY||Odds Ratio (OR)|0.73||||0.48|TWO_SIDED|95.0|0.3|1.8|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||1.80|0.30|0.48
71672151|NCT04498182|142862575|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0302|TWO_SIDED|95.0|-12.1|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-12.1|0.0302
71790589|NCT05167734|143078959|SUPERIORITY||Odds Ratio (OR)|2.13||||0.54|TWO_SIDED|95.0|0.19|24.0|||Regression, Logistic|logistic models adjusting for baseline hemoglobin, age, sex, and surgical vs. non-surgical admission|Estimates are odds ratios and correspond to the multiplicative increase in odds for the given event associated with intervention associated with active intervention|3-months post hospitalization||24.0|0.19|0.54
71892526|NCT00486902|143306487|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||||||0.87
71892527|NCT00486902|143306488|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Fisher Exact|||||||0.90
71892528|NCT00486902|143306489|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Fisher Exact|||||||0.24
71892529|NCT00486902|143306490|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71892530|NCT00486902|143306491|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.6||||0.02|TWO_SIDED|95.0|-1.1|-0.09|||Wilcoxon (Mann-Whitney)|||||-0.09|-1.1|0.02
71892531|NCT03895203|143306509|SUPERIORITY||Odds Ratio (OR)|7.082|||<|0.001|TWO_SIDED|95.0|4.583|10.943|||Regression, Logistic|||||10.943|4.583|<0.001
71892532|NCT03895203|143306510|SUPERIORITY||Least square (LS) mean difference|-0.187|||<|0.001|TWO_SIDED|95.0|-0.249|-0.125|||ANCOVA|||||-0.125|-0.249|<0.001
71892533|NCT03895203|143306512|SUPERIORITY||Odds Ratio (OR)|63.039|||<|0.001|TWO_SIDED|95.0|22.211|178.918|||Regression, Logistic|||||178.918|22.211|<0.001
71892534|NCT03895203|143306513|SUPERIORITY||LS mean difference|4.337|||<|0.001|TWO_SIDED|95.0|3.229|5.444|||ANCOVA|||||5.444|3.229|<0.001
71892535|NCT03895203|143306514|SUPERIORITY||Odds Ratio (OR)|5.447|||<|0.001|TWO_SIDED|95.0|3.668|8.088|||Regression, Logistic|||||8.088|3.668|<0.001
71892536|NCT03895203|143306515|SUPERIORITY||LS mean difference|-0.327||||0.001|TWO_SIDED|95.0|-0.524|-0.13|||ANOVA|||||-0.130|-0.524|0.001
71892537|NCT03895203|143306516|SUPERIORITY||Odds Ratio (OR)|1.904||||0.008|TWO_SIDED|95.0|1.18|3.074|||Regression, Logistic|||||3.074|1.180|0.008
71892538|NCT03895203|143306517|SUPERIORITY||Odds Ratio (OR)|3.437||||0.002|TWO_SIDED|95.0|1.559|7.574|||Regression, Logistic|||||7.574|1.559|0.002
71892539|NCT03895203|143306519|SUPERIORITY||LS mean difference|-0.281||||0.001|TWO_SIDED|95.0|-0.452|-0.111|||ANCOVA|||||-0.111|-0.452|0.001
71892540|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.562|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.357|0.885||||||Comparison at 6 h post first dose||0.885|0.357|
71892541|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.612|STANDARD_ERROR_OF_MEAN|0.281|||TWO_SIDED|95.0|0.349|1.072||||||Comparison at 12 h post first dose||1.072|0.349|
71892542|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.518|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|0.274|0.981||||||Comparison at 18 h post first dose||0.981|0.274|
71892543|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.416|STANDARD_ERROR_OF_MEAN|0.326|||TWO_SIDED|95.0|0.217|0.796||||||Comparison at 24 h post first dose||0.796|0.217|
71838372|NCT01160211|143184474|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0063|TWO_SIDED|95.0|0.45|0.88||Pike estimate of the treatment hazard ratio, \<1 indicates a lower risk compared with trastuzumab + AI.|Log Rank|using a two-sided stratified log-rank test (based on stratification factors)||Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.||0.88|0.45|0.0063
71838373|NCT01160211|143184476|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.44|0.79||||||||0.79|0.44|
71790590|NCT02604212|143078963|SUPERIORITY||LS Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.102||0.6815|TWO_SIDED|95.0|-0.243|0.159|||MMRM|||||0.159|-0.243|0.6815
71790591|NCT02604212|143078963|SUPERIORITY||LS Mean Difference|-0.438|STANDARD_ERROR_OF_MEAN|0.101|<|0.0001|TWO_SIDED|95.0|-0.638|-0.237|||MMRM|||||-0.237|-0.638|<.0001
71790592|NCT02604212|143078963|SUPERIORITY||LS Mean Difference|-0.396|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.569|-0.223|||MMRM|||||-0.223|-0.569|<.0001
71790593|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.208|STANDARD_ERROR_OF_MEAN|0.083||0.0131|TWO_SIDED|95.0|-0.372|-0.044|||MMRM|||Day 15||-0.044|-0.372|0.0131
71790594|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.247|STANDARD_ERROR_OF_MEAN|0.084||0.0036|TWO_SIDED|95.0|-0.412|-0.082|||MMRM|||Day 15||-0.082|-0.412|0.0036
71838374|NCT01160211|143184476|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.66|1.15||||||||1.15|0.66|
71672152|NCT04498182|142862575|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.92||0.8013|TWO_SIDED|95.0|-6.5|5.0|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.0|-6.5|0.8013
71672153|NCT04498182|142862576|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
71790595|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.039|STANDARD_ERROR_OF_MEAN|0.077||0.6136|TWO_SIDED|95.0|-0.192|0.113|||MMRM|||Day 15||0.113|-0.192|0.6136
71790596|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.085|STANDARD_ERROR_OF_MEAN|0.083||0.3104|TWO_SIDED|95.0|-0.249|0.08|||MMRM|||Day 29||0.080|-0.249|0.3104
71790597|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.174|STANDARD_ERROR_OF_MEAN|0.084||0.0401|TWO_SIDED|95.0|-0.34|-0.008|||MMRM|||Day 29||-0.008|-0.340|0.0401
71790598|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.077||0.2494|TWO_SIDED|95.0|-0.242|0.063|||MMRM|||Day 29||0.063|-0.242|0.2494
71790599|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.211|STANDARD_ERROR_OF_MEAN|0.085||0.0149|TWO_SIDED|95.0|-0.38|-0.042|||MMRM|||Day 43||-0.042|-0.380|0.0149
71838375|NCT01160211|143184476|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.51|0.92||||||||0.92|0.51|
71838376|NCT01160211|143184482|SUPERIORITY||Least square difference|-1.79|STANDARD_ERROR_OF_MEAN|2.111|||TWO_SIDED|95.0|-5.95|2.36||||||FACT-B total score||2.36|-5.95|
71838377|NCT01160211|143184482|SUPERIORITY||Least square difference|-3.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-8.09|0.29||||||FACT-B total score||0.29|-8.09|
71838378|NCT01160211|143184482|SUPERIORITY||Least square difference|-1.5|STANDARD_ERROR_OF_MEAN|1.739|||TWO_SIDED|95.0|-4.92|1.92||||||FACT-G total score||1.92|-4.92|
71790600|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.319|STANDARD_ERROR_OF_MEAN|0.086||0.0003|TWO_SIDED|95.0|-0.489|-0.149|||MMRM|||Day 43||-0.149|-0.489|0.0003
71790601|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.108|STANDARD_ERROR_OF_MEAN|0.078||0.1655|TWO_SIDED|95.0|-0.262|0.045|||MMRM|||Day 29||0.045|-0.262|0.1655
71790602|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.088||0.0889|TWO_SIDED|95.0|-0.324|0.023|||MMRM|||Day 57||0.023|-0.324|0.0889
71790603|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.322|STANDARD_ERROR_OF_MEAN|0.088||0.0004|TWO_SIDED|95.0|-0.497|-0.147|||MMRM|||Day 57||-0.147|-0.497|0.0004
71790604|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.172|STANDARD_ERROR_OF_MEAN|0.078||0.0298|TWO_SIDED|95.0|-0.326|-0.017|||MMRM|||Day 57||-0.017|-0.326|0.0298
71790605|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.184|STANDARD_ERROR_OF_MEAN|0.089||0.0415|TWO_SIDED|95.0|-0.361|-0.007|||MMRM|||Day 71||-0.007|-0.361|0.0415
71790606|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.441|STANDARD_ERROR_OF_MEAN|0.091|<|0.0001|TWO_SIDED|95.0|-0.62|-0.261|||MMRM|||Day 71||-0.261|-0.620|<.0001
71672154|NCT04498182|142862576|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
71672155|NCT04498182|142862577|SUPERIORITY|||||||0.3365|||||||Wilcoxon (Mann-Whitney)|||||||0.3365
71672156|NCT04498182|142862577|SUPERIORITY|||||||0.7323|||||||Wilcoxon (Mann-Whitney)|||||||0.7323
71672157|NCT04498182|142862578|SUPERIORITY|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||||||0.1557
71672158|NCT04498182|142862578|SUPERIORITY|||||||0.6845|||||||Wilcoxon (Mann-Whitney)|||||||0.6845
71672159|NCT04498182|142862579|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.52||0.8166|TWO_SIDED|95.0|-4.4|5.5|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||5.5|-4.4|0.8166
71672160|NCT04498182|142862579|SUPERIORITY|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center|LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|2.52||0.3371|TWO_SIDED|95.0|-2.5|7.4|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.4|-2.5|0.3371
71672161|NCT04498182|142862580|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
71790607|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.079||0.0015|TWO_SIDED|95.0|-0.413|-0.1|||MMRM|||Day 71||-0.100|-0.413|0.0015
71790608|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.092||0.351|TWO_SIDED|95.0|-0.268|0.096|||MMRM|||Day 85||0.096|-0.268|0.3510
71790609|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.404|STANDARD_ERROR_OF_MEAN|0.094|<|0.0001|TWO_SIDED|95.0|-0.59|-0.219|||MMRM|||Day 85||-0.219|-0.590|<.0001
71790610|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.318|STANDARD_ERROR_OF_MEAN|0.082||0.0002|TWO_SIDED|95.0|-0.481|-0.156|||MMRM|||Day 85||-0.156|-0.481|0.0002
71790611|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.151|STANDARD_ERROR_OF_MEAN|0.096||0.1198|TWO_SIDED|95.0|-0.341|0.04|||MMRM|||Day 99||0.040|-0.341|0.1198
71838379|NCT01160211|143184482|SUPERIORITY||Least square difference|-3.1|STANDARD_ERROR_OF_MEAN|1.751|||TWO_SIDED|95.0|-6.55|0.34||||||FACT-G total score||0.34|-6.55|
71672162|NCT04498182|142862580|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
71672163|NCT04498182|142862581|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.81||0.5215|TWO_SIDED|95.0|-3.7|7.3|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||7.3|-3.7|0.5215
71672164|NCT04498182|142862581|SUPERIORITY||LS Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|2.81||0.1312|TWO_SIDED|95.0|-1.3|9.8|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||9.8|-1.3|0.1312
71672165|NCT04498182|142862582|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
71672166|NCT04498182|142862582|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
71672167|NCT04498182|142862583|SUPERIORITY||LS Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.99||0.0254|TWO_SIDED|95.0|-8.4|-0.6|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||-0.6|-8.4|0.0254
71672168|NCT04498182|142862583|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.99||0.1362|TWO_SIDED|95.0|-6.9|0.9|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.9|-6.9|0.1362
71790612|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.516|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.708|-0.325|||MMRM|||Day 99||-0.325|-0.708|<.0001
71790613|NCT02604212|143078964|SUPERIORITY||LS Mean Difference|-0.366|STANDARD_ERROR_OF_MEAN|0.085|<|0.0001|TWO_SIDED|95.0|-0.535|-0.197|||MMRM|||Day 99||-0.197|-0.535|<.0001
71790614|NCT02604212|143078965|SUPERIORITY|||||||0.0867|||||||Fisher Exact|||||||0.0867
71790615|NCT02604212|143078965|SUPERIORITY|||||||0.6285|||||||Fisher Exact|||||||0.6285
71790616|NCT02604212|143078965|SUPERIORITY|||||||0.7214|||||||Fisher Exact|||||||0.7214
71790617|NCT02604212|143078966|SUPERIORITY|||||||0.0325|||||||Fisher Exact|||||||0.0325
71790618|NCT02604212|143078966|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
71790619|NCT02604212|143078966|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71790620|NCT02604212|143078967|SUPERIORITY|||||||0.0824|||||||Fisher Exact|||||||0.0824
71790621|NCT02604212|143078967|SUPERIORITY|||||||0.2217|||||||Fisher Exact|||||||0.2217
71790622|NCT02604212|143078967|SUPERIORITY|||||||0.1409|||||||Fisher Exact|||||||0.1409
71790623|NCT02604212|143078968|SUPERIORITY|||||||0.0625|||||||Fisher Exact|||||||0.0625
71790624|NCT02604212|143078968|SUPERIORITY|||||||0.0684|||||||Fisher Exact|||||||0.0684
71790625|NCT02604212|143078968|SUPERIORITY|||||||0.2105|||||||Fisher Exact|||||||0.2105
71790626|NCT02604212|143078969|SUPERIORITY|||||||0.175|||||||Fisher Exact|||||||0.1750
71790627|NCT02604212|143078969|SUPERIORITY|||||||0.0229|||||||Fisher Exact|||||||0.0229
71790628|NCT02604212|143078969|SUPERIORITY|||||||0.0294|||||||Fisher Exact|||||||0.0294
71790629|NCT02604212|143078970|SUPERIORITY|||||||0.4615|||||||Fisher Exact|||||||0.4615
71790630|NCT02604212|143078970|SUPERIORITY|||||||0.0508|||||||Fisher Exact|||||||0.0508
71790631|NCT02604212|143078970|SUPERIORITY|||||||0.0769|||||||Fisher Exact|||||||0.0769
71790632|NCT02604212|143078971|SUPERIORITY|||||||0.0699|||||||Fisher Exact|||||||0.0699
71790633|NCT02604212|143078971|SUPERIORITY|||||||0.0179|||||||Fisher Exact|||||||0.0179
71790634|NCT02604212|143078971|SUPERIORITY|||||||0.043|||||||Fisher Exact|||||||0.0430
71790635|NCT02604212|143078972|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0000
71790636|NCT02604212|143078972|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
71790637|NCT02604212|143078972|SUPERIORITY|||||||0.0849|||||||Fisher Exact|||||||0.0849
71672169|NCT04498182|142862584|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
71672170|NCT04498182|142862584|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
71672171|NCT04498182|142862585|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.06||0.0573|TWO_SIDED|95.0|-8.0|0.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||0.1|-8.0|0.0573
71672172|NCT04498182|142862585|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.06||0.993|TWO_SIDED|95.0|-4.0|4.1|||ANCOVA|Based on analysis of covariance (ANCOVA) models with effects of treatment, baseline, and analysis center||||4.1|-4.0|0.9930
71790638|NCT00598663|143078982|SUPERIORITY||Mean Difference (Final Values)|0.43|||<|0.0001|ONE_SIDED|97.5|||||ANCOVA|ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.||||||<0.0001
71790639|NCT01119131|143078989|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||ANOVA|||||||0.699
71790640|NCT01119131|143078990|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||ANOVA|||||||0.308
71790641|NCT01119131|143078991|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||ANOVA|||||||0.419
71790642|NCT01119131|143078992|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED||||||ANOVA|||||||0.253
71790643|NCT01119131|143078993|SUPERIORITY_OR_OTHER|||||||0.793|TWO_SIDED||||||ANOVA|||||||0.793
71672173|NCT04498182|142862586|SUPERIORITY||Odds Ratio (OR)|1.48||||0.3068|TWO_SIDED|95.0|0.7|3.15|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.15|0.70|0.3068
71790644|NCT01119131|143078995|SUPERIORITY_OR_OTHER|||||||0.949|TWO_SIDED||||||ANOVA|||||||0.949
71790645|NCT01119131|143078996|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||||||0.957
71790646|NCT01341964|143078997|SUPERIORITY||Median Difference (Final Values)|0.05||||0.66|TWO_SIDED||||||t-test, 2 sided|not normally distributed, values were log-transformed.||||||0.66
71790647|NCT01516424|143079000|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|3.69|||<|0.05|TWO_SIDED|95.0|-0.36|7.75||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is ITT analysis data.|"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||7.75|-0.36|<0.05
71672174|NCT04498182|142862586|SUPERIORITY||Odds Ratio (OR)|1.22||||0.6167|TWO_SIDED|95.0|0.56|2.68|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.68|0.56|0.6167
71672175|NCT04498182|142862587|SUPERIORITY||Odds Ratio (OR)|0.64||||0.2867|TWO_SIDED|95.0|0.28|1.46|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.46|0.28|0.2867
71672176|NCT04498182|142862587|SUPERIORITY||Odds Ratio (OR)|0.7||||0.3803|TWO_SIDED|95.0|0.32|1.57|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.57|0.32|0.3803
71790648|NCT01516424|143079000|NON_INFERIORITY_OR_EQUIVALENCE|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|2.94|||<|0.05|TWO_SIDED|95.0|-0.76|6.65||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is PPS analysis data.|"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone\> 7.0)."||6.65|-0.76|<0.05
71790649|NCT04501666|143079097|SUPERIORITY||Strata adjusted percentage difference|40.1|||<|0.0001|TWO_SIDED|95.0|29.4|50.8||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||50.8|29.4|< 0.0001
71672177|NCT04498182|142862588|SUPERIORITY||Odds Ratio (OR)|1.44||||0.4375|TWO_SIDED|95.0|0.58|3.58|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.58|0.58|0.4375
71790650|NCT04501666|143079098|SUPERIORITY||Strata adjusted percentage difference|14.6||||0.0025|TWO_SIDED|95.0|6.7|22.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||22.6|6.7|0.0025
71790651|NCT04501666|143079100|SUPERIORITY||Strata adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.0|40.4||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||40.4|23.0|< 0.0001
71838380|NCT01160211|143184482|SUPERIORITY||Least square difference|-2.7|STANDARD_ERROR_OF_MEAN|1.502|||TWO_SIDED|95.0|-5.66|0.25||||||FACT-B trial outcome index (TOI)||0.25|-5.66|
71838381|NCT01160211|143184482|SUPERIORITY||Least square difference|-3.61|STANDARD_ERROR_OF_MEAN|1.512|||TWO_SIDED|95.0|-6.59|-0.64||||||FACT-B trial outcome index (TOI)||-0.64|-6.59|
71838382|NCT01160211|143184482|SUPERIORITY||Least square difference|-1.46|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.82|-0.11||||||Physical well-being (PWB)||-0.11|-2.82|
71790652|NCT04501666|143079101|SUPERIORITY||Strata adjusted percentage difference|30.5|||<|0.0001|TWO_SIDED|95.0|22.3|38.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.7|22.3|< 0.0001
71790653|NCT04501666|143079102|SUPERIORITY||Strata adjusted percentage difference|38.0|||<|0.0001|TWO_SIDED|95.0|27.8|48.2||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.2|27.8|< 0.0001
71672178|NCT04498182|142862588|SUPERIORITY||Odds Ratio (OR)|1.3||||0.584|TWO_SIDED|95.0|0.51|3.27|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||3.27|0.51|0.5840
71790654|NCT04501666|143079103|SUPERIORITY||Strata adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.7|30.7||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||30.7|14.7|< 0.0001
71790655|NCT04501666|143079104|SUPERIORITY||Strata adjusted percentage difference|18.7|||<|0.0001|TWO_SIDED|95.0|12.3|25.0||A 2-sided p-value was derived from CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.0|12.3|< 0.0001
71790656|NCT01722071|143079107|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.890
71790657|NCT01722071|143079107|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.422
71790658|NCT01722071|143079107|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED|||||The a priori threshold for statistical significance was p\<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.||||0.814
71790659|NCT01698801|143079125|SUPERIORITY_OR_OTHER||Overall dichotomized response rate|87.5|||<|0.0001|TWO_SIDED|95.0|74.269|100.0||One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.|Binomial test for dichotomized response|||||100|74.269|<0.0001
71790660|NCT00680043|143079153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.79|0.29|||ANOVA|||||0.29|-0.79|
71790661|NCT00680043|143079153|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|97.5|-0.56|0.52|||ANOVA|||||0.52|-0.56|
71790662|NCT00680043|143079155|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.84|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.84|
71790663|NCT00680043|143079155|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.92|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.92|
71790664|NCT00553150|143079156|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|70.0|||||TWO_SIDED|||||||||||||
71790665|NCT03061331|143079162|SUPERIORITY||Least Squares Mean Difference|0.1||||0.9277|TWO_SIDED|95.0|-2.5|2.7|||Mixed Model Repeated Measure (MMRM)|||||2.7|-2.5|0.9277
71790666|NCT01686633|143079173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.045|0.171|||ANCOVA|||||0.171|0.045|<0.001
71790667|NCT01686633|143079173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.037|0.086||||||||0.086|-0.037|
71790668|NCT03761147|143079210|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71790669|NCT03204305|143079228|SUPERIORITY||t-test|-2.51||||0.02|TWO_SIDED|||||p \< 0.05 for all analyses. Bonferroni corrections were made to reduce family-wise error rate.|t-test, 2 sided|Composite VT was compared using independent t-tests.||VT in the 8 volumes of interest were analyzed using linear regression model group coded encoded as a dummy variable \[1=females cannabis users; 2= female healthy controls\], age as a covariate, and VT for VOIs (ventral striatum, amygdala, putamen, cingulate, globus pallidus, insula, frontal cortex, and hippocampus) as dependent variables, followed by post hoc Tukey's HSD between between groups.||||0.02
71790670|NCT03204305|143079228|SUPERIORITY||t-test|-2.36||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71790671|NCT03204305|143079228|SUPERIORITY||t-test|-2.35||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71790672|NCT03204305|143079228|SUPERIORITY||t-test|-2.23||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71790673|NCT03204305|143079229|SUPERIORITY||t test|-2.52||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71790674|NCT01765153|143079302|SUPERIORITY_OR_OTHER|||||||0.04366667|||||||t-test, 2 sided|||||||0.04366667
71790675|NCT00319644|143079353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.26||95.0|||||Chi-squared|||The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.||||0.26
71790676|NCT00312494|143079488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1077||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint||||0.1077
71790677|NCT00312494|143079488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||95.0||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.||||0.4274
71790678|NCT00312494|143079489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4025
71790679|NCT00312494|143079489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.2830
71790680|NCT00312494|143079489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4125||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.4125
71790681|NCT00312494|143079489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1527||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.||||0.1527
71790682|NCT00312494|143079490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0101||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0101
71790683|NCT00312494|143079490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0694
71790684|NCT00312494|143079490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0183||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0183
71790685|NCT00312494|143079490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0176
71790686|NCT00312494|143079490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2302||95.0||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.2302
71790687|NCT00312494|143079490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0796||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.||||0.0796
71790688|NCT00312494|143079491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6191||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6191
71790689|NCT00312494|143079491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5629||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.5629
71790690|NCT00312494|143079491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.9049
71790691|NCT00312494|143079491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7153||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.7153
71838383|NCT01160211|143184482|SUPERIORITY||Least square difference|-1.54|STANDARD_ERROR_OF_MEAN|0.693|||TWO_SIDED|95.0|-2.9|-0.18||||||Physical well-being (PWB)||-0.18|-2.90|
71672179|NCT04498182|142862589|SUPERIORITY||Odds Ratio (OR)|0.73||||0.5046|TWO_SIDED|95.0|0.29|1.84|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||1.84|0.29|0.5046
71672180|NCT04498182|142862589|SUPERIORITY||Odds Ratio (OR)|1.27||||0.5751|TWO_SIDED|95.0|0.56|2.88|||Cochran-Mantel-Haenszel|Adjusted by analysis center||||2.88|0.56|0.5751
71790692|NCT00312494|143079491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.2420
71790693|NCT00312494|143079491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6121||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.||||0.6121
71790694|NCT00312494|143079492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6138||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6138
71790695|NCT00312494|143079492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6536||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.6536
71790696|NCT00312494|143079492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4758||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.4758
71790697|NCT00312494|143079492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7581||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.7581
71790698|NCT00312494|143079492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2221||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.2221
71790699|NCT00312494|143079492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5665||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.||||0.5665
71790700|NCT00312494|143079493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.1063
71790701|NCT00312494|143079493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2499||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.||||0.2499
71790702|NCT00312494|143079493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0876||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.0876
71790703|NCT00312494|143079493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3623||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.||||0.3623
71790704|NCT00312494|143079493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4686||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.4686
71790705|NCT00312494|143079493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2202||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.||||0.2202
71790706|NCT00312494|143079494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0728||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.0728
71790707|NCT00312494|143079494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3174||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.||||0.3174
71790708|NCT00312494|143079495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.4460
71838384|NCT01160211|143184482|SUPERIORITY||Least square difference|0.39|STANDARD_ERROR_OF_MEAN|0.711|||TWO_SIDED|95.0|-1.01|1.79||||||Social family wellbeing (SWB)||1.79|-1.01|
71838385|NCT01160211|143184482|SUPERIORITY||Least square difference|-0.55|STANDARD_ERROR_OF_MEAN|0.715|||TWO_SIDED|95.0|-1.96|0.86||||||Social family wellbeing (SWB)||0.86|-1.96|
71838386|NCT01160211|143184482|SUPERIORITY||Least square difference|0.54|STANDARD_ERROR_OF_MEAN|0.568|||TWO_SIDED|95.0|-0.57|1.66||||||Emotional wellbeing (EWB)||1.66|-0.57|
71790709|NCT00312494|143079495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3253||95.0||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.||||0.3253
71790710|NCT03232281|143079497|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was confirmed.|Rate difference (%)|-0.7|||||TWO_SIDED|95.0|-4.41|2.58|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||2.58|-4.41|
71790711|NCT03232281|143079498|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
71790712|NCT03232281|143079498|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-6.8|-0.16|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.16|-6.80|
71790713|NCT03232281|143079499|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-1.3|||||TWO_SIDED|95.0|-5.26|1.93|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 4. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.93|-5.26|
71790714|NCT03232281|143079499|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-4.1|||||TWO_SIDED|95.0|-8.93|-0.52|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 8. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||-0.52|-8.93|
71790715|NCT03232281|143079499|NON_INFERIORITY|If the lower limit of the 95% CI for the difference was \>-10%, triptorelin pamoate PR 3-month non-inferiority to triptorelin acetate PR 1-month was observed without multiplicity adjustment.|Rate difference (%)|-2.7|||||TWO_SIDED|95.0|-7.44|1.17|||||The rate difference (triptorelin pamoate PR 3-month - triptorelin acetate PR 1-month) and the 2-sided 95% CI of the difference were calculated using the Miettinen and Nurminen method, stratified by randomisation stratification factors.|Rate difference at Week 12. The null hypothesis was that triptorelin pamoate PR 3-month was inferior to triptorelin acetate PR 1-month. The alternative hypothesis was that triptorelin pamoate PR 3-month was non-inferior to triptorelin acetate PR 1-month.||1.17|-7.44|
71790716|NCT00605813|143079513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."||||0.003
71790717|NCT00605813|143079514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."||||<0.001
71790718|NCT00605813|143079515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders."||||0.040
71838387|NCT01160211|143184482|SUPERIORITY||Least square difference|0.4|STANDARD_ERROR_OF_MEAN|0.571|||TWO_SIDED|95.0|-0.72|1.53||||||Emotional wellbeing (EWB)||1.53|-0.72|
71838388|NCT01160211|143184482|SUPERIORITY||Least square difference|-0.99|STANDARD_ERROR_OF_MEAN|0.646|||TWO_SIDED|95.0|-2.26|0.28||||||Functional wellbeing (FWB)||0.28|-2.26|
71838389|NCT01160211|143184482|SUPERIORITY||Least square difference|-1.32|STANDARD_ERROR_OF_MEAN|0.649|||TWO_SIDED|95.0|-2.6|-0.04||||||Functional wellbeing (FWB)||-0.04|-2.60|
71838390|NCT01160211|143184482|SUPERIORITY||Least square difference|-0.35|STANDARD_ERROR_OF_MEAN|0.665|||TWO_SIDED|95.0|-1.66|0.95||||||Breast cancer subscale (BCS)||0.95|-1.66|
71838391|NCT01160211|143184482|SUPERIORITY||Least square difference|-0.83|STANDARD_ERROR_OF_MEAN|0.668|||TWO_SIDED|95.0|-2.14|0.48||||||Breast cancer subscale (BCS)||0.48|-2.14|
71892544|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.517|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|0.262|1.021||||||Comparison at 48 h post first dose||1.021|0.262|
71892545|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.661|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|0.291|1.503||||||Comparison at 72 h post first dose||1.503|0.291|
71790719|NCT00605813|143079516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders."||||0.004
71790720|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL versus \[v.\] \>1.5 mg/dL).||||||<0.001
71790721|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790722|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790723|NCT00174915|143079517|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|25.7||||||97.5|16.7|34.7||||||||34.7|16.7|
71790724|NCT00174915|143079517|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is \> -10%.|Difference in percentage|42.7||||||97.5|34.0|51.3||||||||51.3|34.0|
71790725|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790726|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790727|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790728|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790729|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790730|NCT00174915|143079517|SUPERIORITY_OR_OTHER|||||||0.479||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.479
71790731|NCT00174915|143079517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790732|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790733|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790734|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790735|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790736|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790737|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790738|NCT00174915|143079518|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.011
71838392|NCT04342494|143184511|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PHQ-9 score via analysis of covariance.||||||0.31|||||||ANCOVA|||||||0.31
71838393|NCT04342494|143184512|EQUIVALENCE|Average mood score obtained from daily measurements analyzed via analysis of variance||||||0.0073|||||||ANOVA|||||||0.0073
71838394|NCT04342494|143184513|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-PI score via analysis of covariance||||||0.03|||||||ANCOVA|||||||0.03
71790739|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790740|NCT00174915|143079518|SUPERIORITY_OR_OTHER|||||||0.091||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.091
71790741|NCT00174915|143079518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790742|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71672181|NCT02667704|142862611|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|98.85|STANDARD_DEVIATION|11.4|||TWO_SIDED|90.0|91.32|107.01|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||107.010|91.320|
71790743|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790744|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790745|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790746|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790747|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790748|NCT00174915|143079519|SUPERIORITY_OR_OTHER|||||||0.074||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.074
71790749|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790750|NCT00174915|143079519|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.001
71790751|NCT00174915|143079519|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||<0.001
71790752|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790753|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790754|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71838395|NCT04342494|143184514|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline PANSI-NSI score via analysis of covariance||||||0.71|||||||ANCOVA|||||||0.71
71672182|NCT02667704|142862612|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|103.36|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|86.134|124.025|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||124.025|86.134|
71672183|NCT02667704|142862613|SUPERIORITY_OR_OTHER||Ratio of geometric means in percentage|101.98|STANDARD_DEVIATION|10.3|||TWO_SIDED|90.0|94.909|109.57|||ANOVA||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect||109.570|94.909|
71790755|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790756|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790757|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790758|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790759|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790760|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790761|NCT00174915|143079520|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790762|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790763|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790764|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790765|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790766|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71672184|NCT00832455|142862614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
71790767|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71672185|NCT00832455|142862614|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||||||<0.001
71672186|NCT00832455|142862616|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.||||||<0.001
71790768|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790769|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790770|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790771|NCT00174915|143079521|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA|||||||<0.001
71790772|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.789||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.789
71790773|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.32||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.320
71672187|NCT00832455|142862616|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.||||||<0.001
71790774|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.381||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.381
71790775|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.809
71790776|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.154||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.154
71790777|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.247||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.247
71790778|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.415
71790779|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.649||95.0||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.649
71790780|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.807||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.807
71790781|NCT00174915|143079522|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.844
71790782|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.699
71790783|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.822
71790784|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.579
71790785|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.679||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.679
71790786|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.278
71790787|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.104
71790788|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.560
71672188|NCT00832455|142862617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.||||||<0.001
71790789|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.309||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.309
71790790|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.759
71790791|NCT00174915|143079523|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.385
71790792|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.949
71790793|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.050
71790794|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.577
71790795|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.598||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.598
71790796|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.062||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.062
71790797|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.969
71790798|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.056
71790799|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.659
71790800|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.197||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.197
71790801|NCT00174915|143079524|SUPERIORITY_OR_OTHER|||||||0.521||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.521
71790802|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.683
71790803|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.078
71790804|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.442
71790805|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.990
71790806|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.077
71790807|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.662||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.662
71790808|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.139
71790809|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.705
71672189|NCT00832455|142862618|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|Change in PACQLQ score between Week 12 and baseline is statistically different than zero||||||<0.001
71790810|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.337||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.337
71790811|NCT00174915|143079525|SUPERIORITY_OR_OTHER|||||||0.643||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.643
71790812|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.645||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.645
71790813|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.756
71790814|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.428
71790815|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.076||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons..|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL)||||||0.076
71790816|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.106
71790817|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.069
71790818|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.837
71790819|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.749
71790820|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.581
71790821|NCT00174915|143079526|SUPERIORITY_OR_OTHER|||||||0.311||95.0||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. \>1.5 mg/dL).||||||0.311
71672190|NCT04548193|142862620|SUPERIORITY||Mean Difference (Final Values)|6.14||||0.28|TWO_SIDED|95.0|-5.72|17.99|||Wilcoxon (Mann-Whitney)|||||17.99|-5.72|0.28
71672191|NCT04548193|142862621|SUPERIORITY||Mean Difference (Final Values)|0.72||||0.0054|TWO_SIDED|95.0|0.06|1.38|||Wilcoxon (Mann-Whitney)|||||1.38|0.06|.0054
71672192|NCT04548193|142862623|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0098|TWO_SIDED|95.0|0.24|1.65|||Wilcoxon (Mann-Whitney)|||||1.65|0.24|.0098
71790822|NCT00183092|143079527|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.43||||0.43|TWO_SIDED|95.0|0.58|3.53|||Regression, Cox|||||3.53|0.58|0.43
71790823|NCT00183092|143079528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.54||95.0||||Threshold for statistical significance = 0.05. One subject in the placebo group was administered only 25 items on the MMSE due to visual impairment, and this subject's score was scaled based on percentage correct.|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.54
71790824|NCT00183092|143079529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.9||||0.36||95.0||||significance threshold p=0.05|Quade's rank analysis of covariance|||The difference between scores, adjusted for Month-0 performance.||||.36
71790825|NCT00183092|143079530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.01||95.0||||Significance threshold p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||.01
71790826|NCT00183092|143079531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.03||95.0||||Threshold for significance p\<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.03
71838396|NCT04342494|143184515|EQUIVALENCE|Symptom-level change estimates were adjusted for baseline GAD-7 score via analysis of covariance||||||0.31|||||||ANCOVA|||||||0.31
71838397|NCT04806451|143184517|SUPERIORITY||LS Mean Difference|-267.775|STANDARD_ERROR_OF_MEAN|68.313||0.0002|TWO_SIDED|95.0|-403.427|-132.124|||ANCOVA|||||-132.124|-403.427|0.0002
71790827|NCT00183092|143079532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.92||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.92
71790828|NCT00183092|143079533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.||||0.71
71790829|NCT00183092|143079534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.7||95.0||||Significance threshold p\<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted change (worsening) in the quinacrine group.||||0.70
71790830|NCT02132767|143079535|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71790831|NCT02132767|143079536|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
71790832|NCT02132767|143079537|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
71790833|NCT02132767|143079538|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
71790834|NCT02132767|143079539|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71790835|NCT02132767|143079540|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71790836|NCT02132767|143079541|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.82
71790837|NCT02132767|143079542|SUPERIORITY_OR_OTHER|||||||0.73|||||||Regression, Poisson|||||||0.73
71790838|NCT00778700|143079555|SUPERIORITY||Least Squares (LS) Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.406||0.0041|TWO_SIDED|90.0|-1.85|-0.51|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.51|-1.85|0.0041
71790839|NCT00778700|143079555|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.408||0.0007|TWO_SIDED|90.0|-2.08|-0.73|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.73|-2.08|0.0007
71790840|NCT00778700|143079555|SUPERIORITY||LS Mean Difference|-1.21|STANDARD_ERROR_OF_MEAN|0.407||0.0035|TWO_SIDED|90.0|-1.88|-0.53|||ANCOVA|The ANCOVA model included treatment as the main factor and Baseline score as the covariate.||||-0.53|-1.88|0.0035
71790841|NCT01304966|143079593|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 1 sided|||||||0.013
71790842|NCT00003901|143079597|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.59||||0.007|TWO_SIDED|95.0|1.13|2.23|||Regression, Cox|||||2.23|1.13|0.007
71790843|NCT00003901|143079598|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.886|TWO_SIDED|95.0|0.69|1.54|||Regression, Cox|||||1.54|0.69|0.886
71790844|NCT00003901|143079599|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.63||||0.009|TWO_SIDED|95.0|1.13|2.36|||Regression, Cox|||||2.36|1.13|0.009
71790845|NCT00003901|143079600|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.78||||0.332|TWO_SIDED|95.0|0.48|1.28|||Regression, Cox|||||1.28|0.48|0.332
71790846|NCT00527943|143079601|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.072|TWO_SIDED|95.0|0.85|1.01|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.01|0.85|0.072
71790847|NCT00527943|143079602|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.018|TWO_SIDED|95.0|0.81|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.81|0.018
71790848|NCT00527943|143079603|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.36|||<|0.001|TWO_SIDED|95.0|1.18|1.57|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.57|1.18|<0.001
71790849|NCT00527943|143079604|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.29|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.29|<0.001
71790850|NCT00527943|143079605|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.038|TWO_SIDED|95.0|0.84|1.0|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.00|0.84|0.038
71838398|NCT05835336|143184524|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.45|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71838399|NCT05835336|143184525|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.9|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71838400|NCT05835336|143184526|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|3.55||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71838401|NCT05835336|143184527|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|5.16||||0.032|TWO_SIDED||||||t-test, 2 sided|||||||0.032
71790851|NCT00527943|143079606|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.027|TWO_SIDED|95.0|0.81|0.99|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.99|0.81|0.027
71790852|NCT00527943|143079607|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.94||||0.174|TWO_SIDED|95.0|0.87|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.87|0.174
71790853|NCT00527943|143079608|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.108|TWO_SIDED|95.0|0.86|1.02|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.02|0.86|0.108
71790854|NCT00527943|143079609|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.963|TWO_SIDED|95.0|0.83|1.22|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.22|0.83|0.963
71790855|NCT00527943|143079610|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.021|TWO_SIDED|95.0|0.79|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.79|0.021
71790856|NCT00527943|143079611|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.418|TWO_SIDED|95.0|0.83|1.58|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.58|0.83|0.418
71790857|NCT00527943|143079612|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.07||||0.493|TWO_SIDED|95.0|0.88|1.31|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.31|0.88|0.493
71790858|NCT00527943|143079613|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05||||0.515|TWO_SIDED|95.0|0.9|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.90|0.515
71790859|NCT00527943|143079614|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.606|TWO_SIDED|95.0|0.7|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.23|0.70|0.606
71790860|NCT00680745|143079629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.0867|<|0.0001|TWO_SIDED|95.0|-0.61|-0.27||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)||-0.27|-0.61|<0.0001
71790861|NCT00680745|143079629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.0885|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.32|-0.67|<0.0001
71790862|NCT00680745|143079629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.0873|<|0.0001|TWO_SIDED|95.0|-0.86|-0.51||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).||-0.51|-0.86|<0.0001
71838402|NCT05835336|143184529|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|7.58||||0.035|TWO_SIDED||||||t-test, 2 sided|||||||0.035
71838403|NCT05835336|143184530|SUPERIORITY|Considering the exploratory nature of the study, a sample size of at least 0.5 (Cohen's D) for a 2-Tailed test, at alpha-0.05 with a power of 80%, was chosen to detect significant within-subject effects.|Mean Difference (Final Values)|-1.13||||0.521|TWO_SIDED||||||t-test, 2 sided|||||||.521
71672193|NCT02275819|142862650|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||.14
71672194|NCT02275819|142862651|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||||||.22
71672195|NCT02275819|142862652|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||||||.12
71672196|NCT02275819|142862653|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||.08
71672197|NCT02275819|142862654|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||||||0.43
71672198|NCT02211209|142862655|SUPERIORITY||Least Squares Mean Difference|-94.1|||<|0.0001|TWO_SIDED|95.0|-121.7|-66.6|||ANCOVA|||||-66.6|-121.7|< 0.0001
71790863|NCT00680745|143079630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.3153||0.141|TWO_SIDED|95.0|-1.08|0.15||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.15|-1.08|0.1410
71790864|NCT00680745|143079630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3217||0.0091|TWO_SIDED|95.0|-1.47|-0.21||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.21|-1.47|0.0091
71790865|NCT00680745|143079630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.3168|<|0.0001|TWO_SIDED|95.0|-2.17|-0.92||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.92|-2.17|<0.0001
71790866|NCT00680745|143079631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.5|STANDARD_ERROR_OF_MEAN|6.874|||TWO_SIDED|95.0|-45.0|-18.0||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-18.0|-45.0|
71790867|NCT00680745|143079631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.0|STANDARD_ERROR_OF_MEAN|6.968||0.0002|TWO_SIDED|95.0|-39.7|-12.3||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.3|-39.7|0.0002
71790868|NCT00680745|143079631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.9|STANDARD_ERROR_OF_MEAN|6.77|<|0.0001|TWO_SIDED|95.0|-42.2|-15.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-15.6|-42.2|<0.0001
71790869|NCT00680745|143079632|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.7|STANDARD_ERROR_OF_MEAN|4.265|||TWO_SIDED|95.0|5.4|22.1||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||22.1|5.4|
71790870|NCT00680745|143079632|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3|STANDARD_ERROR_OF_MEAN|4.392||0.0001|TWO_SIDED|95.0|8.7|25.9||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||25.9|8.7|0.0001
71790871|NCT00680745|143079632|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|4.457|<|0.0001|TWO_SIDED|95.0|9.9|27.4||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||27.4|9.9|<0.0001
71790872|NCT00680745|143079633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.4159|||TWO_SIDED|95.0|-1.19|0.45||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||0.45|-1.19|
71790873|NCT00680745|143079633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.4234||0.0262|TWO_SIDED|95.0|-1.78|-0.11||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.11|-1.78|0.0262
71790874|NCT00680745|143079633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.4211|<|0.0001|TWO_SIDED|98.0|-2.5|-0.84||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.84|-2.50|<0.0001
71790875|NCT00680745|143079634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|3.522|||TWO_SIDED|95.0|-21.8|-7.9||Not significant. Hierarchical closed testing procedure within treatment group stopped at previous endpoint.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-7.9|-21.8|
71838404|NCT02023866|143184653|OTHER|||||||0.1875|||||||Wilcoxon Signed Rank|||Section I - Current Function Null hypothesis = change from baseline is 0.||||0.1875
71672199|NCT02211209|142862657|SUPERIORITY||Least Squares Mean Difference|-1804.0|STANDARD_ERROR_OF_MEAN|251.0|<|0.0001|TWO_SIDED|95.0|-2306.0|-1302.0|||ANCOVA|||||-1302|-2306|< 0.0001
71790876|NCT00680745|143079634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3|STANDARD_ERROR_OF_MEAN|3.594|<|0.0001|TWO_SIDED|95.0|-26.3|-12.2||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-12.2|-26.3|<0.0001
71672200|NCT02211209|142862658|SUPERIORITY||Odds Ratio (OR)|186.16||||0.0001|TWO_SIDED|95.0|12.86||NA indicates that the upper limit of 95% CI was not estimable. The upper limit of the odds ratio estimate from the logistic regression model was \>999.999, and it was reported as NA per statistical reporting convention.||Regression, Logistic||||||12.86|0.0001
71672201|NCT02211209|142862659|SUPERIORITY||Odds Ratio (OR)|99.69|||<|0.0001|TWO_SIDED|95.0|15.75|631.06|||Regression, Logistic|||||631.06|15.75|<0.0001
71790877|NCT00680745|143079634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|3.545|<|0.0001|TWO_SIDED|95.0|-33.5|-19.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-19.5|-33.5|<0.0001
71790878|NCT00137423|143079638|SUPERIORITY_OR_OTHER||Objective Response Rate|28.3||||||95.0|16.8|42.3|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||42.3|16.8|
71790879|NCT00137423|143079638|SUPERIORITY_OR_OTHER||Objective Response Rate|11.5||||||95.0|4.4|23.4|||F distribution|||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was \<=5% versus alternative hypothesis that true response rate was \>=15% with 90% power and alpha level of 0.05. If number of OR\> =11 null hypothesis that true response rate was \<=5% could be rejected with a target α error rate of 0.05.||23.4|4.4|
71790880|NCT00137423|143079642|SUPERIORITY_OR_OTHER||1-year survival rate|77.4||||||95.0|63.6|86.5|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||86.5|63.6|
71790881|NCT00137423|143079642|SUPERIORITY_OR_OTHER||1-year survival rate|66.0||||||95.0|51.6|77.1|||Kaplan-Meier method||valid presentation only if at least 1 patient has overall survival \>=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.|||77.1|51.6|
71790882|NCT02141997|143079655|SUPERIORITY_OR_OTHER||||||=|0.863|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.863
71790883|NCT02141997|143079655|SUPERIORITY_OR_OTHER||||||=|0.414|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.414
71790884|NCT02141997|143079655|SUPERIORITY_OR_OTHER||||||=|0.196|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.||||=0.196
71790885|NCT04105998|143079666|SUPERIORITY|Exploratory analysis without power calculation||||||0.64|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.64
71790886|NCT04105998|143079667|SUPERIORITY|Exploratory analysis without power calculation||||||0.19|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.19
71672202|NCT02211209|142862661|SUPERIORITY|||||||0.6131|||||||t-test, 2 sided|||||||0.6131
71672203|NCT02211209|142862662|SUPERIORITY||Least Squares Mean Difference|138.0||||0.1206|TWO_SIDED|95.0|-36.0|312.0|||ANCOVA|||||312|-36|0.1206
71672204|NCT01575834|142862686|SUPERIORITY||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.15|0.47||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.47|0.15|< 0.001
71672205|NCT01575834|142862687|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.39||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.39|0.15|< 0.001
71790887|NCT04105998|143079668|SUPERIORITY|Exploratory analysis without power calculation||||||0.067|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.067
71790888|NCT04105998|143079669|SUPERIORITY|Exploratory analysis without power calculation||||||0.25|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.25
71790889|NCT04105998|143079670|SUPERIORITY|Exploratory analysis without power calculation||||||0.058|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.058
71790890|NCT04105998|143079671|SUPERIORITY|Exploratory analysis without power calculation||||||0.111|||||||t-test, 2 sided|||Exploratory analysis without power calculation||||0.111
71790891|NCT01857232|143079742|SUPERIORITY|||||||0.004|||||||Regression, Logistic|||||||0.004
71790892|NCT01857232|143079742|SUPERIORITY|||||||0.0987|||||||Regression, Logistic|||||||0.0987
71790893|NCT01857232|143079742|SUPERIORITY|||||||0.1041|||||||Regression, Logistic|||||||0.1041
71790894|NCT01857232|143079743|SUPERIORITY|||||||0.0235|||||||Chi-squared, Corrected|1-sided||||||0.0235
71790895|NCT01857232|143079743|SUPERIORITY|||||||0.1651|||||||Chi-squared, Corrected|1-sided||||||0.1651
71838405|NCT02023866|143184653|OTHER|||||||1|||||||Wilcoxin Signed Rank|||Section II - System Specific Involvement Null hypothesis = change from baseline is 0.||||1.0000
71790896|NCT01857232|143079743|SUPERIORITY|||||||0.1332|||||||Chi-squared, Corrected|1-sided||||||0.1332
71790897|NCT00416078|143079744|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||F test of time X group effect F(1,3)=.26|Mixed Models Analysis|||intent to treat||||.65
71790898|NCT00416078|143079745|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED|||||t test of differential change over time in the two groups t(30)=.67|Mixed Models Analysis|||intent to treat analysis||||.51
71790899|NCT00416078|143079746|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|||||t test of differential change over time in the two groups t(29)=.27|Mixed Models Analysis|||intent to treat analysis||||.79
71790900|NCT00416078|143079747|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.70|Mixed Models Analysis|||intent to treat analysis||||.49
71790901|NCT00416078|143079748|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||t test for differential change over time in the two groups t(29)=.43|Mixed Models Analysis|||intent to treat analysis||||.67
71790902|NCT00416078|143079749|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||||||.64
71790903|NCT02335099|143079759|SUPERIORITY||Odds Ratio (OR)|3.77||||0.32|TWO_SIDED|95.0|0.27|217.52|||Fisher Exact|||||217.52|0.27|0.32
71790904|NCT02335099|143079760|SUPERIORITY||Cox Proportional Hazard|0.86||||0.82|TWO_SIDED|95.0|0.23|3.2|||Log Rank|||||3.20|0.23|0.82
71790905|NCT02461225|143079761|SUPERIORITY||||||<|0.0005|||||||Fisher Exact|||||||<.0005
71790906|NCT02461225|143079762|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71790907|NCT00484939|143079763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
71790908|NCT00484939|143079764|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.||||0.029
71838406|NCT02023866|143184653|OTHER|||||||0.0781|||||||Wilcoxin Signed Rank|||Section III - Current Clinical Assessment Null hypothesis = change from baseline is 0.||||0.0781
71790909|NCT00484939|143079767|SUPERIORITY_OR_OTHER|||||||0.13|||||||Log Rank|||||||0.130
71790910|NCT00469092|143079800|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.|Mean Difference (Net)|-0.16||||0.029||95.0|-0.3|-0.02||P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.|Regression, Linear|||HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.||-0.02|-0.30|0.029
71790911|NCT00469092|143079801|SUPERIORITY_OR_OTHER|||||||0.0059||95.0||||P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.|Mixed Models Analysis|||The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.||||0.0059
71790912|NCT00469092|143079802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.914||||||95.0|0.57|1.47|||||The OR and 95% CI is for the HbA1c \<= 6.5% treatment target.|||1.47|0.57|
71790913|NCT00469092|143079802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||||95.0|0.67|1.54|||||The OR and 95% CI is for the HbA1c \< 7.0% treatment target.|||1.54|0.67|
71838407|NCT02023866|143184653|OTHER|||||||0.2941|||||||t-test, 2 sided|One-sample t-test||Section IV - Quality of Life Null hypothesis = change from baseline is 0.||||0.2941
71838408|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|-0.37||||0.011|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M2-M3)||||0.011
71838409|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|-0.69||||0.008|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of G. vaginalis at baseline and during Nuvaring Use (M3-M6)||||0.008
71892546|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.908|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|0.366|2.254||||||Comparison at 96 h post first dose||2.254|0.366|
71790914|NCT00469092|143079802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.131||||||95.0|0.72|1.77|||||The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.|||1.77|0.72|
71790915|NCT00469092|143079802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.905||||||95.0|0.59|1.38|||||The OR and 95% CI is for the HbA1c \< 7% no nocturnal (00:00-06:00) hypoglycemia treatment target|||1.38|0.59|
71790916|NCT00469092|143079802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.181||||||95.0|0.74|1.87|||||The OR and 95% CI is for the HbA1c \< 7%, no daytime (06:01-23:59) hypoglycemia treatment target|||1.87|0.74|
71790917|NCT00469092|143079802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.122||||||95.0|0.69|1.82|||||The OR and 95% CI is for the HbA1c \< 7%, no hypoglycemia treatment target.|||1.82|0.69|
71790918|NCT00469092|143079803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||||95.0|-2.4|2.48|||||The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.48|-2.40|
71790919|NCT00469092|143079803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||||95.0|-3.56|3.11|||||The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||3.11|-3.56|
71790920|NCT00469092|143079803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||||95.0|-3.14|2.35|||||The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.35|-3.14|
71790921|NCT00469092|143079803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||||95.0|-2.36|2.14|||Regression, Linear||The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.||2.14|-2.36|
71790922|NCT02024867|143079806|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.|Rate Difference|4.0||||0.25|TWO_SIDED|95.0|-1.5|9.5|||Chi-squared|||||9.5|-1.5|0.25
71790923|NCT02024867|143079807|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.7||||0.02|TWO_SIDED|95.0|2.1|19.2|||Chi-squared|||||19.2|2.1|0.02
71838410|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.08||||0.662|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M2-M3)||||0.662
71790924|NCT02024867|143079808|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.1||||0.03|TWO_SIDED|95.0|2.1|18.2|||Chi-squared|||||18.2|2.1|0.03
71790925|NCT02024867|143079809|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|0.1|||>|0.05|TWO_SIDED|95.0|-6.9|7.0|||Chi-squared|||||7.0|-6.9|>0.05
71790926|NCT02024867|143079810|NON_INFERIORITY_OR_EQUIVALENCE|described previously|Rate Difference|10.3||||0.046|TWO_SIDED|95.0|0.8|19.9|||Chi-squared|||||19.9|0.8|0.046
71790927|NCT02024867|143079811|NON_INFERIORITY_OR_EQUIVALENCE|described previously|rate difference|0.0|||>|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||>0.05
71790928|NCT03992781|143079841|SUPERIORITY||Relative change|-53.1|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790929|NCT03992781|143079842|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in CUDOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790930|NCT03992781|143079843|SUPERIORITY||Relative change|-33.2|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790931|NCT03992781|143079843|SUPERIORITY||Relative change|-47.1|||<|0.001|||||||t-test|||Relative change in CUXOS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790932|NCT03992781|143079844|SUPERIORITY||Relative change|-27.6|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790933|NCT03992781|143079844|SUPERIORITY||Relative change|-34.5|||<|0.001|||||||t-test|||Relative change in JSEQ score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790934|NCT03992781|143079845|SUPERIORITY||Relative change|-43.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 2 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790935|NCT03992781|143079845|SUPERIORITY||Relative change|-35.4|||<|0.001|||||||t-test|||Relative change in VAS score between Visit 3 and Visit 1 was tested by ratio t-test (paired t-test of logarithm) at 0.05 alpha level. This was expressed in percentage.||||<0.001
71790936|NCT03033511|143079876|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.537|TWO_SIDED|95.0|0.84|1.36||stratified log-rank test|Log Rank|||||1.36|0.84|0.537
71790937|NCT03033511|143079877|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.237|TWO_SIDED|95.0|0.92|1.36||stratified log-rank test|Log Rank|||||1.36|0.92|0.237
71892547|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.195|||TWO_SIDED|95.0|0.52|1.134||||||Comparison at 6 h post first dose||1.134|0.520|
71892548|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.701|STANDARD_ERROR_OF_MEAN|0.248|||TWO_SIDED|95.0|0.427|1.15||||||Comparison at 12 h post first dose||1.150|0.427|
71790938|NCT03033511|143079878|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.36|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|95.0|-3.08|2.35||||||Change at Week 6||2.35|-3.08|
71790939|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|-10.43|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-14.58|-6.29||||||Change at Week 12||-6.29|-14.58|
71790940|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|-27.67|STANDARD_ERROR_OF_MEAN|10.57|||TWO_SIDED|95.0|-46.19|-9.16||||||Change at Week 18||-9.16|-46.19|
71790941|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|-18.44|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-38.28|1.39||||||Change at Week 24||1.39|-38.28|
71790942|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|-22.0|STANDARD_ERROR_OF_MEAN|11.27|||TWO_SIDED|95.0|-42.63|-1.37||||||Change at Week 30||-1.37|-42.63|
71790943|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 36||||
71790944|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|3.33|||||TWO_SIDED|||||||||Change at Week 42||||
71790945|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|-56.67|||||TWO_SIDED|||||||||Change at Week 48||||
71790946|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 60||||
71790947|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 66||||
71790948|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|0.0|||||TWO_SIDED|||||||||Change at Week 78||||
71790949|NCT03033511|143079878|SUPERIORITY||LS Mean of Difference|-9.17|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-12.16|-6.19||||||Change at Final Visit||-6.19|-12.16|
71790950|NCT00531817|143080109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.85|||<|0.0001|TWO_SIDED|95.0|12.29|25.42||The p-value was not adjusted. The primary objective was a single comparison with an a priori threshold of 0.05 for statistical significance.|Fisher Exact|||Power calculation: Assuming placebo+DMARDs response rate of 15% and tocilizumab 8 mg/kg+DMARDs response rate of 28% based on previous trials, a sample size of 570 patients (2:1 ratio, tocilizumab+DMARDs n=380 and placebo+DMARDs n=190) will provide \> 90% power to detect a difference between 2 treatment arms with 5% Type I error with a 2-sided Fisher's exact test. Null Hypothesis: The percentage of patients responding in each treatment group (tocilizumab+DMARDs vs placebo+ DMARDs) is the same.||25.42|12.29|<0.0001
71790951|NCT03338855|143080119|SUPERIORITY||Least Square (LS) Mean Difference|-1.068|STANDARD_ERROR_OF_MEAN|1.014||0.3047|TWO_SIDED|95.0|-3.183|1.047|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RD (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||1.047|-3.183|0.3047
71790952|NCT03338855|143080120|SUPERIORITY||LS Mean Difference|-1.705|STANDARD_ERROR_OF_MEAN|0.517||0.0036|TWO_SIDED|95.0|-2.784|-0.625|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs low insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.625|-2.784|0.0036
71790953|NCT03338855|143080120|SUPERIORITY||LS Mean Difference|-2.292|STANDARD_ERROR_OF_MEAN|0.409|<|0.0001|TWO_SIDED|95.0|-3.146|-1.438|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta EGP (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-1.438|-3.146|<0.0001
71790954|NCT03338855|143080121|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.009||0.1842|TWO_SIDED|95.0|-0.006|0.03|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of delta RER (basal vs high insulin) between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.030|-0.006|0.1842
71790955|NCT03338855|143080122|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.005||0.0001|TWO_SIDED|95.0|-0.033|-0.013|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of 24-hour RER between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.013|-0.033|0.0001
71790956|NCT03338855|143080123|SUPERIORITY||LS Mean Difference|-0.109|STANDARD_ERROR_OF_MEAN|0.065||0.1095|TWO_SIDED|95.0|-0.245|0.027|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of energy expenditure between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||0.027|-0.245|0.1095
71790957|NCT03338855|143080124|SUPERIORITY||LS Mean Difference|-246.7|STANDARD_ERROR_OF_MEAN|464.3||0.6005|TWO_SIDED|95.0|-1209.5|716.2|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of fat mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||716.2|-1209.5|0.6005
71790958|NCT03338855|143080124|SUPERIORITY||LS Mean Difference|-666.5|STANDARD_ERROR_OF_MEAN|301.1||0.0376|TWO_SIDED|95.0|-1291.0|-41.9|||Linear Mixed Effects Model|A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.||Comparison of lean mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-41.9|-1291.0|0.0376
71790959|NCT03338855|143080125|SUPERIORITY||LS Mean Difference|-1.256|STANDARD_ERROR_OF_MEAN|0.289||0.0003|TWO_SIDED|95.0|-1.854|-0.657|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of total mass between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||-0.657|-1.854|0.0003
71790960|NCT03338855|143080126|SUPERIORITY||LS Mean Difference|-244.301|STANDARD_ERROR_OF_MEAN|165.168||0.1555|TWO_SIDED|95.0|-590.002|101.401|||Linear Mixed Effects Model||A linear mixed model with treatment group, treatment sequence, and period as fixed effects and patient as random effect.|Comparison of FGF21 AUC between dapagliflozin and placebo after 5 weeks of treatment was performed using a random effects analysis of variance model.||101.401|-590.002|0.1555
71790961|NCT00056407|143080134|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.3|||<|0.0001||95.0|15.6|30.3||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data given are for the overall assessment.|||30.3|15.6|<0.0001
71790962|NCT00056407|143080135|SUPERIORITY_OR_OTHER||Relative Risk Reduction|23.1|||<|0.0001||95.0|15.5|30.0||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data are given are for the overall assessment.|||30.0|15.5|<0.0001
71790963|NCT00056407|143080136|SUPERIORITY_OR_OTHER||Relative Risk Reduction|22.8|||<|0.0001||95.0|15.2|29.8||The p value is given for the overall assessment.|Mantel-Cox||Estimation data are given for the overall assessment.|||29.8|15.2|<0.0001
71790964|NCT00056407|143080159|SUPERIORITY_OR_OTHER||Difference in adjusted means|18.8|||<|0.001||95.0|17.3|20.4|||general linear model, t-test||The adjusted mean difference was calculated as the difference between the adjusted means (-6.1 and 12.7) for the placebo and Dutasteride arms, respectively.|||20.4|17.3|<0.001
71790965|NCT00951808|143080162|SUPERIORITY_OR_OTHER||optimal threshold level of sPLA2|48.0|STANDARD_DEVIATION|5.0|||TWO_SIDED|95.0|38.0|58.0|||||The optimal threshold level (TL) was determined to be the same for all analysis groups.|The optimal threshold level (TL), determined via receiver operating characteristic (ROC) curve analysis, maximizes the difference between the true positive rate (TPR) and the false positive rate (FPR). Since there is no corresponding analytic standard deviation (SD) for this value, we computed a robust SD based upon the interquartile range (IQR)/1.35 from a bootstrap sample of optimal TLs.||58|38|
71790966|NCT00455429|143080166|SUPERIORITY_OR_OTHER|||||||0.6|||||||Cochran-Mantel-Haenszel|||||||0.600
71790967|NCT00455429|143080166|SUPERIORITY_OR_OTHER|||||||0.822|||||||Cochran-Mantel-Haenszel|||||||0.822
71790968|NCT00455429|143080166|SUPERIORITY_OR_OTHER|||||||0.656|||||||Cochran-Mantel-Haenszel|||||||0.656
71790969|NCT00455429|143080167|SUPERIORITY_OR_OTHER||LS Mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.63||0.427|TWO_SIDED|95.0|-9.7|2.9|||Dunnett-Hsu|||||2.90|-9.70|0.427
71790970|NCT00455429|143080167|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.55||0.922|TWO_SIDED|95.0|-7.37|4.82|||Dunnett-Hsu|||||4.82|-7.37|0.922
71790971|NCT00455429|143080167|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.24||0.919|TWO_SIDED|95.0|-6.49|4.21|||Dunnett-Hsu|||||4.21|-6.49|0.919
71790972|NCT00455429|143080168|SUPERIORITY_OR_OTHER||LS Mean difference|3.7|STANDARD_ERROR_OF_MEAN|8.15||0.941|TWO_SIDED|95.0|-15.83|23.18|||Dunnett-Hsu|||||23.18|-15.83|0.941
71790973|NCT00455429|143080168|SUPERIORITY_OR_OTHER||LS Mean Difference|14.2|STANDARD_ERROR_OF_MEAN|8.07||0.196|TWO_SIDED|95.0|-5.12|33.52|||Dunnett-Hsu|||||33.52|-5.12|0.196
71790974|NCT00455429|143080168|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|7.08||0.096|TWO_SIDED|95.0|-2.0|31.86|||Dunnett-Hsu|||||31.86|-2.00|0.096
71790975|NCT00455429|143080169|SUPERIORITY_OR_OTHER|||||||0.46|||||||Regression, Logistic|||||||0.460
71790976|NCT00455429|143080169|SUPERIORITY_OR_OTHER|||||||0.479|||||||Regression, Logistic|||||||0.479
71790977|NCT00455429|143080169|SUPERIORITY_OR_OTHER|||||||0.462|||||||Regression, Logistic|||||||0.462
71790978|NCT00455429|143080170|SUPERIORITY_OR_OTHER|||||||0.363|||||||Regression, Logistic|||||||0.363
71790979|NCT00455429|143080170|SUPERIORITY_OR_OTHER|||||||0.968|||||||Regression, Logistic|||||||0.968
71790980|NCT00455429|143080170|SUPERIORITY_OR_OTHER|||||||0.501|||||||Regression, Logistic|||||||0.501
71790981|NCT00455429|143080171|SUPERIORITY_OR_OTHER|||||||0.333|||||||Regression, Logistic|||||||0.333
71790982|NCT00455429|143080171|SUPERIORITY_OR_OTHER|||||||0.527|||||||Regression, Logistic|||||||0.527
71790983|NCT00455429|143080171|SUPERIORITY_OR_OTHER|||||||0.353|||||||Regression, Logistic|||||||0.353
71790984|NCT00455429|143080172|SUPERIORITY_OR_OTHER|||||||0.631|||||||Regression, Logistic|||||||0.631
71790985|NCT00455429|143080172|SUPERIORITY_OR_OTHER|||||||0.523|||||||Regression, Logistic|||||||0.523
71790986|NCT00455429|143080172|SUPERIORITY_OR_OTHER|||||||0.101|||||||Regression, Logistic|||||||0.101
71790987|NCT00455429|143080173|SUPERIORITY_OR_OTHER|||||||0.429|||||||Regression, Logistic|||||||0.429
71790988|NCT00455429|143080173|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
71790989|NCT00455429|143080173|SUPERIORITY_OR_OTHER|||||||0.107|||||||Regression, Logistic|||||||0.107
71790990|NCT00455429|143080174|SUPERIORITY_OR_OTHER|||||||0.097|||||||Regression, Logistic|||||||0.097
71790991|NCT00455429|143080174|SUPERIORITY_OR_OTHER|||||||0.077|||||||Regression, Logistic|||||||0.077
71790992|NCT00455429|143080174|SUPERIORITY_OR_OTHER|||||||0.489|||||||Regression, Logistic|||||||0.489
71790993|NCT00455429|143080175|SUPERIORITY_OR_OTHER|||||||0.566|||||||Regression, Logistic|||||||0.566
71790994|NCT00455429|143080175|SUPERIORITY_OR_OTHER|||||||0.382|||||||Regression, Logistic|||||||0.382
71790995|NCT00455429|143080175|SUPERIORITY_OR_OTHER|||||||0.282|||||||Regression, Logistic|||||||0.282
71790996|NCT00455429|143080176|SUPERIORITY_OR_OTHER|||||||0.206|||||||Regression, Logistic|||||||0.206
71790997|NCT00455429|143080176|SUPERIORITY_OR_OTHER|||||||0.433|||||||Regression, Logistic|||||||0.433
71790998|NCT00455429|143080176|SUPERIORITY_OR_OTHER|||||||0.29|||||||Regression, Logistic|||||||0.290
71790999|NCT00455429|143080177|SUPERIORITY_OR_OTHER|||||||0.484|||||||Regression, Logistic|||||||0.484
71838411|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.48||||0.41|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. iners at baseline and during Nuvaring Use (M3-M6)||||0.41
71838412|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.23||||0.164|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M2-M3)||||0.164
71838413|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.35||||0.183|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|||Mean quantity of L. crispatus at baseline and during Nuvaring Use (M3-M6)||||0.183
71838414|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.12||||0.506|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M2-M3)||||0.506
71838415|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.38||||0.119|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of L. jensenii at baseline and during Nuvaring Use (M3-M6)||||0.119
71838416|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M2-M3)||||0.510
71838417|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|-0.3||||0.168|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of Megasphaera at baseline and during Nuvaring Use (M3-M6)||||0.168
71838418|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|0.07||||0.454|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M2-M3)||||0.454
71838419|NCT02432404|143184666|OTHER||Mean Difference (Final Values)|-0.1||||0.471|TWO_SIDED|||||p\<0.05 is considered statistically significant.|Random effects mixed model|Random effects mixed model: random effects for subject and time category, with unstructured covariance, and AR(1) residuals; and robust SEs.||Mean quantity of BVAB2 at baseline and during Nuvaring Use (M3-M6)||||0.471
71838420|NCT04963270|143184668|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_DEVIATION|0.44||0.0196|TWO_SIDED|95.0|-1.88|-0.16|||ANCOVA and Conditional Mean Imputation|||||-0.16|-1.88|0.0196
71791000|NCT00455429|143080177|SUPERIORITY_OR_OTHER|||||||0.952|||||||Regression, Logistic|||||||0.952
71791001|NCT00455429|143080177|SUPERIORITY_OR_OTHER|||||||0.35|||||||Regression, Logistic|||||||0.350
71838421|NCT04963270|143184669|SUPERIORITY||Difference in Adjusted Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.41||0.0123|TWO_SIDED|95.0|-1.82|-0.22|||ANCOVA and Conditional Mean Imputation|||||-0.22|-1.82|0.0123
71838422|NCT04963270|143184670|SUPERIORITY||Difference in Response Rate|-12.7||||0.088|TWO_SIDED|95.0|-27.3|1.9|||Cochran-Mantel-Haenszel|||Stratified Analysis||1.9|-27.3|0.088
71838423|NCT04963270|143184671|SUPERIORITY||Difference in Response Rate|-10.5||||0.137|TWO_SIDED|95.0|-24.2|3.3|||Cochran-Mantel-Haenszel|||Stratified Analysis||3.3|-24.2|0.137
71838424|NCT04963270|143184672|SUPERIORITY||Difference in Adjusted Mean|-1.63|STANDARD_ERROR_OF_MEAN|0.6||0.0062|TWO_SIDED|95.0|-2.8|-0.46|||ANCOVA and Conditional Mean Imputation|||||-0.46|-2.80|0.0062
71838425|NCT04963270|143184673|SUPERIORITY||Difference in adjusted Mean|-1.68|STANDARD_ERROR_OF_MEAN|0.57||0.0034|TWO_SIDED|95.0|-2.8|-0.56|||ANCOVA and Conditional Mean Imputation|||||-0.56|-2.80|0.0034
71791002|NCT04351087|143080203|EQUIVALENCE|Power analysis based on (MCID) for the KOOS-Pain, alpha 0.05 \& SD 15 points, 88 patients (44/group) would be required to detect a 9-point difference between treatment groups with 80% power. Due to change in regulatory requirements during accrual, enrollment was halted at 79 patients with 71 meeting inclusion criteria. A repeated power calculation demonstrated that the study achieved 56% power to detect a between-group difference in excess of the 9-point MCID for the KOOS-Pain.|Mean Difference (Final Values)|2.17||||0.69|TWO_SIDED|95.0|-8.57|12.92|||t-test, 2 sided|||||12.92|-8.57|0.69
71791003|NCT05517382|143080226|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||At baseline||||0.20
71791004|NCT05517382|143080226|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||At Post game||||0.59
71791005|NCT05517382|143080226|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||At 3 month||||0.94
71791006|NCT05517382|143080226|SUPERIORITY|||||||0.55|||||||GEE|Controlling for baseline thriving status, this reflects the interaction between the intervention group and time.||||||0.55
71791007|NCT05517382|143080227|SUPERIORITY||Mean Difference (Net)|-0.09||||0.1759|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis||Group effect.|At post game.||0.04|-0.23|0.1759
71791008|NCT05517382|143080227|SUPERIORITY||Mean Difference (Net)|-0.16||||0.0857|TWO_SIDED|95.0|-0.35|0.02|||Mixed Models Analysis||Group effect.|At 3 month||0.02|-0.35|0.0857
71791009|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066||||0.036|TWO_SIDED|95.0|0.004|0.127|||Mixed Models Analysis|||||0.127|0.004|0.036
71791010|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.331|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.090|-0.030|0.331
71791011|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||Mixed Models Analysis|||||0.095|-0.027|0.272
71791012|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.005|TWO_SIDED|95.0|0.026|0.149|||Mixed Models Analysis|||||0.149|0.026|0.005
71791013|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.722|TWO_SIDED|95.0|-0.05|0.073|||Mixed Models Analysis|||||0.073|-0.050|0.722
71791014|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057||||0.076|TWO_SIDED|95.0|-0.006|0.119|||Mixed Models Analysis|||||0.119|-0.006|0.076
71791015|NCT01641692|143080237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051||||0.101|TWO_SIDED|95.0|-0.01|0.113|||Mixed Models Analysis|||||0.113|-0.010|0.101
71791016|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.84|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.840
71791017|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.553|TWO_SIDED|95.0|-2.4|1.3|||Mixed Models Analysis|||||1.3|-2.4|0.553
71791018|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.121|TWO_SIDED|95.0|-0.4|3.3|||Mixed Models Analysis|||||3.3|-0.4|0.121
71791019|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.814|TWO_SIDED|95.0|-2.1|1.7|||Mixed Models Analysis|||||1.7|-2.1|0.814
71791020|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.683|TWO_SIDED|95.0|-1.5|2.3|||Mixed Models Analysis|||||2.3|-1.5|0.683
71791021|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.456|TWO_SIDED|95.0|-1.2|2.7|||Mixed Models Analysis|||||2.7|-1.2|0.456
71791022|NCT01641692|143080240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.399|TWO_SIDED|95.0|-2.7|1.1|||Mixed Models Analysis|||||1.1|-2.7|0.399
71791023|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.03|TWO_SIDED|95.0|0.2|3.2|||Mixed Models Analysis|||||3.2|0.2|0.030
71791024|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.077|TWO_SIDED|95.0|-0.1|2.8|||Mixed Models Analysis|||||2.8|-0.1|0.077
71791025|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.01|TWO_SIDED|95.0|0.5|3.5|||Mixed Models Analysis|||||3.5|0.5|0.010
71791026|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.002|TWO_SIDED|95.0|0.9|3.9|||Mixed Models Analysis|||||3.9|0.9|0.002
71791027|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.005|TWO_SIDED|95.0|0.7|3.7|||Mixed Models Analysis|||||3.7|0.7|0.005
71791028|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.001|TWO_SIDED|95.0|1.2|4.3|||Mixed Models Analysis|||||4.3|1.2|<0.001
71791029|NCT01641692|143080241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.054|TWO_SIDED|95.0|0.0|3.0|||Mixed Models Analysis|||||3.0|0.0|0.054
71791030|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.4|2.0|||Mixed Models Analysis|||||2.0|-1.4|0.752
71791031|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.072|TWO_SIDED|95.0|-0.1|3.2|||Mixed Models Analysis|||||3.2|-0.1|0.072
71838426|NCT04963270|143184674|SUPERIORITY||Difference in Adjusted Mean|-1.51|STANDARD_ERROR_OF_MEAN|0.94||0.1094|TWO_SIDED|95.0|-3.36|0.34|||ANCOVA and Conditional Mean Imputation|||||0.34|-3.36|0.1094
71791032|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.503|TWO_SIDED|95.0|-1.1|2.2|||Mixed Models Analysis|||||2.2|-1.1|0.503
71791033|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.476|TWO_SIDED|95.0|-1.1|2.3|||Mixed Models Analysis|||||2.3|-1.1|0.476
71791034|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.084|TWO_SIDED|95.0|-0.2|3.2|||Mixed Models Analysis|||||3.2|-0.2|0.084
71791035|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED|95.0|-1.8|1.7|||Mixed Models Analysis|||||1.7|-1.8|0.970
71791036|NCT01641692|143080242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.423|TWO_SIDED|95.0|-2.4|1.0|||Mixed Models Analysis|||||1.0|-2.4|0.423
71791037|NCT00735787|143080284|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Fisher Exact|||The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.||||0.014
71791038|NCT01566461|143080317|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||z-test|||||||<0.001
71791039|NCT01566461|143080318|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71791040|NCT01566461|143080319|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71791041|NCT01566461|143080320|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
71791042|NCT01566461|143080321|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71791043|NCT01566461|143080322|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71791044|NCT01566461|143080323|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||t-test, 1 sided|||||||0.859
71791045|NCT01566461|143080324|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
71791046|NCT01566461|143080325|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
71791047|NCT01566461|143080326|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71791048|NCT01566461|143080327|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
71791049|NCT01566461|143080328|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
71791050|NCT01566461|143080329|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71791051|NCT01566461|143080330|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||t-test, 1 sided|||||||0.095
71791052|NCT01566461|143080331|SUPERIORITY_OR_OTHER|||||||0.878|TWO_SIDED||||||t-test, 1 sided|||||||0.878
71791053|NCT01566461|143080332|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 1 sided|||||||0.590
71791054|NCT01566461|143080333|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
71791055|NCT01566461|143080334|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
71791056|NCT01566461|143080335|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
71791057|NCT01566461|143080336|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 1 sided|||||||0.049
71791058|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.0164|TWO_SIDED||||||Regression, Logistic|||Treatment response and participant age||||0.0164
71791059|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0200
71791060|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.0867
71791061|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Regression, Logistic|||Remission and participant age||||0.0001
71791062|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.0734|TWO_SIDED||||||Regression, Logistic|||Remission and positive tuberculosis screening at Visit 0||||0.0734
71791063|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.0438|TWO_SIDED||||||Regression, Logistic|||Remission and male gender||||0.0438
71791064|NCT01474876|143080347|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI score at Visit 0||||0.5030
71791065|NCT01474876|143080356|SUPERIORITY_OR_OTHER|||||||0.0576|TWO_SIDED||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0||||0.0576
71791066|NCT01474876|143080356|SUPERIORITY_OR_OTHER|||||||0.1739|TWO_SIDED||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0||||0.1739
71791067|NCT01474876|143080356|SUPERIORITY_OR_OTHER|||||||0.0733|TWO_SIDED||||||Regression, Logistic|||Remission and Psoriasis at Visit 0||||0.0733
71791068|NCT01474876|143080356|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Regression, Logistic|||Remission and BASDAI at Visit 0||||0.5000
71791069|NCT00657241|143080393|SUPERIORITY|All hemodynamic variables are continuous and all participants received both treatments, so paired-t analysis could be used. While paired t-tests do not necessarily require a power and sample size analysis, we estimated that 30 subjects were sufficient to detect an 8% difference in CTTI between comparators at p\<0.05 with a conservatively estimated power of 0.8.|||||<|0.05|||||||t-test, 2 sided|||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||<0.05
71791070|NCT00657241|143080395|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
71791071|NCT00657241|143080396|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|Paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
71791072|NCT00657241|143080397|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
71791073|NCT00657241|143080398|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|paired t-test||Statistical analysis performed on treatment groups (valsartan or carvedilol CR) at end of treatment period (4 weeks), not on the randomization arms in the crossover design (which controlled for carryover effects of the prior treatment arm).||||0.05
71791074|NCT02226003|143080416|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.49|-0.84|||Constrained Longitudinal Data Analysis|||||-0.84|-1.49|< 0.001
71791075|NCT02226003|143080416|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.57|-0.91|||Constrained Longitudinal Data Analysis|||||-0.91|-1.57|< 0.001
71791076|NCT02226003|143080417|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.6|||||TWO_SIDED|95.0|-11.2|16.4||||||||16.4|-11.2|
71791077|NCT02226003|143080417|SUPERIORITY_OR_OTHER||Difference in Percentage vs Placebo|2.5|||||TWO_SIDED|95.0|-11.4|16.4||||||||16.4|-11.4|
71791078|NCT02226003|143080419|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-38.94|||<|0.001|TWO_SIDED|95.0|-49.93|-27.96|||Constrained Longitudinal Data Analysis|||||-27.96|-49.93|< 0.001
71791079|NCT02226003|143080419|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.05|||<|0.001|TWO_SIDED|95.0|-57.09|-35.02|||Constrained Longitudinal Data Analysis|||||-35.02|-57.09|< 0.001
71791080|NCT02226003|143080420|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-62.42|||<|0.001|TWO_SIDED|95.0|-80.47|-44.37|||Constrained Longitudinal Data Analysis|||||-44.37|-80.47|< 0.001
71791081|NCT02226003|143080420|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-69.65|||<|0.001|TWO_SIDED|95.0|-87.83|-51.46|||Constrained Longitudinal Data Analysis|||||-51.46|-87.83|< 0.001
71892549|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.578|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.329|1.015||||||Comparison at 18 h post first dose||1.015|0.329|
71892550|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.41|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.231|0.728||||||Comparison at 24 h post first dose||0.728|0.231|
71892551|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.896|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|0.484|1.657||||||Comparison at 48 h post first dose||1.657|0.484|
71892552|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.739|STANDARD_ERROR_OF_MEAN|0.374|||TWO_SIDED|95.0|0.35|1.563||||||Comparison at 72 h post first dose||1.563|0.350|
71791082|NCT02226003|143080421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|2.81|16.83|||Logistic regression model|||||16.83|2.81|< 0.001
71791083|NCT02226003|143080421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.39|||<|0.001|TWO_SIDED|95.0|2.98|18.31|||Logistic regression model|||||18.31|2.98|< 0.001
71791084|NCT02226003|143080422|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.0|||<|0.001|TWO_SIDED|95.0|-2.99|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-2.99|< 0.001
71791085|NCT02226003|143080422|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-3.1|-1.11|||Constrained Longitudinal Data Analysis|||||-1.11|-3.10|< 0.001
71791086|NCT02226003|143080423|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-4.44||||0.011|TWO_SIDED|95.0|-7.87|-1.01|||Constrained Longitudinal Data Analysis|||||-1.01|-7.87|0.011
71791087|NCT02226003|143080423|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-6.39|||<|0.001|TWO_SIDED|95.0|-9.83|-2.95|||Constrained Longitudinal Data Analysis|||||-2.95|-9.83|< 0.001
71791088|NCT02226003|143080424|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.65||||0.184|TWO_SIDED|95.0|-4.09|0.79|||Constrained Longitudinal Data Analysis|||||0.79|-4.09|0.184
71791089|NCT02226003|143080424|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-2.18||||0.08|TWO_SIDED|95.0|-4.62|0.26|||Constrained Longitudinal Data Analysis|||||0.26|-4.62|0.080
71791090|NCT02467465|143080426|SUPERIORITY|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||||||0.175
71791091|NCT02467465|143080427|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.250
71791092|NCT02467465|143080428|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||||||0.466
71791093|NCT02467465|143080430|SUPERIORITY|||||||0.737|||||||Wilcoxon (Mann-Whitney)|||||||0.737
71791094|NCT02467465|143080431|SUPERIORITY|||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
71791095|NCT02467465|143080432|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
71791096|NCT02467465|143080434|SUPERIORITY|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
71791097|NCT02467465|143080435|SUPERIORITY|||||||0.425|||||||Wilcoxon (Mann-Whitney)|||||||0.425
71791098|NCT02467465|143080436|SUPERIORITY|||||||0.487|||||||Wilcoxon (Mann-Whitney)|||||||0.487
71672206|NCT01575834|142862688|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.008|TWO_SIDED|95.0|0.46|0.89||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.89|0.46|0.008
71791099|NCT02467465|143080438|SUPERIORITY|||||||0.651|||||||t-test, 1 sided|||||||0.651
71791100|NCT02467465|143080439|SUPERIORITY|||||||0.387|||||||t-test, 1 sided|||||||0.387
71791101|NCT02467465|143080440|SUPERIORITY|||||||0.755|||||||t-test, 1 sided|||||||0.755
71791102|NCT02467465|143080442|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||0.032
71791103|NCT02467465|143080443|SUPERIORITY|||||||0.058|||||||t-test, 1 sided|||||||0.058
71791104|NCT02467465|143080444|SUPERIORITY|||||||0.279|||||||t-test, 1 sided|||||||0.279
71791105|NCT00670800|143080457|SUPERIORITY_OR_OTHER|||||||0.143||95.0|||||t-test, 2 sided|||||||0.143
71791106|NCT00670800|143080457|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.900
71791107|NCT00670800|143080457|SUPERIORITY_OR_OTHER|||||||0.133||95.0|||||t-test, 2 sided|||||||0.133
71791108|NCT00670800|143080458|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||t-test, 2 sided|||||||0.049
71791109|NCT00670800|143080458|SUPERIORITY_OR_OTHER|||||||0.717||95.0|||||t-test, 2 sided|||||||0.717
71791110|NCT00670800|143080458|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
71791111|NCT00670800|143080459|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||t-test, 2 sided|||||||0.498
71791112|NCT00670800|143080459|SUPERIORITY_OR_OTHER|||||||0.835||95.0|||||t-test, 2 sided|||||||0.835
71791113|NCT00670800|143080459|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||t-test, 2 sided|||||||0.606
71791114|NCT00670800|143080460|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||t-test, 2 sided|||||||0.118
71838427|NCT04963270|143184675|SUPERIORITY||Difference in Adjusted Mean|-1.39|STANDARD_ERROR_OF_MEAN|0.85||0.0999|TWO_SIDED|95.0|-3.05|0.27|||ANCOVA and Conditional Mean Imputation|||||0.27|-3.05|0.0999
71838428|NCT04963270|143184676|SUPERIORITY||Difference in Adjusted Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.1||0.0456|TWO_SIDED|95.0|-4.36|-0.04|||ANCOVA and Conditional Mean Imputation|||||-0.04|-4.36|0.0456
71791115|NCT00670800|143080460|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||t-test, 2 sided|||||||0.581
71791116|NCT00670800|143080460|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||||||0.190
71791117|NCT04736199|143080462|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.0001|TWO_SIDED|95.0|0.413|0.707||One-sided|Log Rank|||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.707|0.413|<0.0001
71791118|NCT04736199|143080463|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.1007|TWO_SIDED|95.0|0.591|1.118||One-sided|Log Rank||significance level of 0.0185 (one-sided)|Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||1.118|0.591|0.1007
71791119|NCT04736199|143080464|OTHER||Hazard Ratio (HR)|0.404|||||TWO_SIDED|95.0|0.321|0.508||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.508|0.321|
71791120|NCT04736199|143080465|OTHER||Hazard Ratio (HR)|0.401|||||TWO_SIDED|95.0|0.288|0.558||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.558|0.288|
71791121|NCT04736199|143080466|OTHER||Hazard Ratio (HR)|0.306|||||TWO_SIDED|95.0|0.231|0.405||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.405|0.231|
71791122|NCT04736199|143080467|OTHER||Rate difference|44.3|||||TWO_SIDED|95.0|37.4|51.2||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||51.2|37.4|
71791123|NCT04736199|143080468|OTHER||Hazard Ratio (HR)|0.721|||||TWO_SIDED|95.0|0.544|0.957||||||Analyzed with log-rank test and Cox regression proportional hazard model, stratified by the same factor as used for randomization visceral disease (present versus absent), prior local therapy (Yes versus No).||0.957|0.544|
71791124|NCT04318080|143080470|SUPERIORITY|Analysis tested whether ORR with tislelizumab was superior to a historical ORR of 45% using a one-sided binomial exact test (α = 0.05).|Z-test|2.62||||0.0044|TWO_SIDED|||||One-sided p-value based on a binomial exact test comparing observed ORR to historical rate of 45%.|Binomial Exact Test|||The primary analysis was conducted on both cohorts combined, A binomial exact test was performed to test the null hypothesis (H0: ORR = 45% based on previous clinical trials) and alternative hypothesis (ORR \>45%). If the one-sided p-value was ≤ 0.05, tislelizumab was considered to statistically significantly increase ORR compared to the historical control.||||0.0044
71838429|NCT04963270|143184677|SUPERIORITY||Difference in Adjusted Mean|-2.11|STANDARD_ERROR_OF_MEAN|1.02||0.0382|TWO_SIDED|95.0|-4.1|-0.11|||ANCOVA and Conditional Mean Imputation|||||-0.11|-4.10|0.0382
71791125|NCT05027438|143080489|SUPERIORITY||Mean Difference (Net)|-7.58|STANDARD_DEVIATION|5.19|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 1.42 (large \>=0.35)|||<0.001
71791126|NCT05027438|143080489|SUPERIORITY||Mean Difference (Net)|-7.06|STANDARD_DEVIATION|4.4|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 1.54 (large \>=0.35)|||<0.001
71791127|NCT05027438|143080490|SUPERIORITY||Mean Difference (Net)|58.55|STANDARD_DEVIATION|43.98||0.004|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to post-treatment||||0.004
71791128|NCT05027438|143080490|SUPERIORITY||Mean Difference (Net)|62.26|STANDARD_DEVIATION|54.93||0.005|TWO_SIDED|||||Bonferroni correction|Friedman test|||% change in medication dose from baseline to 3-month follow-up||||0.005
71791129|NCT05027438|143080491|SUPERIORITY||Proportion (%)|31.8||||0.052|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to post-treatment||||0.052
71791130|NCT05027438|143080491|SUPERIORITY||Proportion (%)|60.0|||<|0.001|TWO_SIDED||||||Cochran's Q test|Bonferroni correction||baseline to 3-month follow-up||||<0.001
71791131|NCT05027438|143080492|SUPERIORITY||Mean Difference (Net)|-16.67|STANDARD_DEVIATION|20.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.54 (large \>=0.35)|||<0.001
71791132|NCT05027438|143080492|SUPERIORITY||Mean Difference (Net)|-17.11|STANDARD_DEVIATION|22.11|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.47 (large \>=0.35)|||<0.001
71791133|NCT05027438|143080493|SUPERIORITY||Mean Difference (Net)|-6.24|STANDARD_DEVIATION|20.34||0.101|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates reduction of symptoms)|baseline to post-treatment|effect size (f2) = 0.10 (small \>=0.02)|||0.101
71791134|NCT05027438|143080493|SUPERIORITY||Mean Difference (Net)|-10.34|STANDARD_DEVIATION|18.28|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates reduction of symptoms)|baseline to 3-month follow-up|effect size (f2) = 0.34 (medium; large \>=0.35)|||<0.001
71791135|NCT05027438|143080494|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)|baseline to post-treatment|effect size (f2) = 0.87 (large \>=0.35)|||<0.001
71791136|NCT05027438|143080494|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_DEVIATION|6.0|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)|baseline to 3-month follow-up|effect size (f2) = 0.96 (large \>=0.35)|||<0.001
71672207|NCT01575834|142862689|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.096|TWO_SIDED|95.0|0.53|1.05||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.05|0.53|0.096
71791137|NCT05027438|143080495|SUPERIORITY||Mean Difference (Net)|-7.48|STANDARD_DEVIATION|6.08|<|0.001|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.14 (large \>=0.35)|||<0.001
71791138|NCT05027438|143080495|SUPERIORITY||Mean Difference (Net)|-7.82|STANDARD_DEVIATION|5.62|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (negative value indicates improvement)|Sleep Disturbance - higher scores indicate more sleep disturbance. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.|effect size (f2) = 1.21 (large \>=0.35)|||<0.001
71791139|NCT05027438|143080496|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_DEVIATION|0.21||0.22|TWO_SIDED||||||Mixed Models Analysis||post-treatment - baseline (positive value indicates improvement)||effect size (f2) = 0.18 (medium \>=0.15)|||0.22
71791140|NCT05027438|143080496|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis||3-month follow-up - baseline (positive value indicates improvement)||effect size (f2) = 1.99 (large \>=0.35)|||<0.001
71791141|NCT01921179|143080541|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score|||||<|0.01|||||||ANOVA|||||||<0.01
71791142|NCT01921179|143080542|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training||||||<0.001
71791143|NCT01921179|143080543|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||||>|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance||||||>0.05
71791144|NCT01921179|143080544|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|||||||<0.001
71791145|NCT01921179|143080545|EQUIVALENCE|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score|||||<|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score||||||<0.05
71791146|NCT01921179|143080546|EQUIVALENCE|A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up|||||<|0.01|||||||ANOVA|||||||<0.01
71791147|NCT00858442|143080617|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks = 0.953, P\> 0.449 in group without PRP and in PRP group shapiro Wilks=0.946, P \> 0.259.~The data were normally distributed, with equal variances (Test of levene: F = 0.1234, P\> 0.99)"|Mean Difference (Final Values)|-2.452|STANDARD_ERROR_OF_MEAN|2.452|>|0.1574|TWO_SIDED|95.0|-7.332|2.428||Applies t-test for equality of means. t = -1.016 is obtained. p\> 0.1574|t-test, 1 sided|||||2.428|-7.332|>0.1574
71791148|NCT00858442|143080618|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks =0.972, P\> 0.687 in group without PRP and in PRP group shapiro Wilks = 0.964, P \> 0.410.~The data were normally distributed, with equal variances (Test of levene: F = 3.153, P\> 0.082)"|Mean Difference (Final Values)|-0.27186|STANDARD_ERROR_OF_MEAN|0.50519|>|0.593|TWO_SIDED|95.0|-1.28561|0.74189||Applies t-test for equality of means. t = -0.538 is obtained. p\> 0.593|t-test, 2 sided|||||0.74189|-1.28561|>0.593
71791149|NCT00858442|143080619|NON_INFERIORITY_OR_EQUIVALENCE|"Applies normality test of shapiro Wilks=0.822, P\<0.001 in group without PRP, and in PRP group shapiro Wilks =0.910, P\<0.017.~The data were no normally distributed, with equal variances (Test of levene, F=1.324, P\>0.255)"|||||>|0.398|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mean rank group without PRP= 28.88 Mean rank group with PRP= 26.31 Z value = -0.027||||||>0.398
71791150|NCT00202644|143080623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-100.5|STANDARD_ERROR_OF_MEAN|39.93|||TWO_SIDED|95.0|-179.42|-21.49||||||||-21.49|-179.42|
71791151|NCT00202644|143080624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-113.1|STANDARD_ERROR_OF_MEAN|37.56|||TWO_SIDED|95.0|-187.4|-38.83||||||Month 3||-38.83|-187.40|
71791152|NCT00202644|143080624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was \> -100 x 10\^9/Liter.|Least Square Mean|-68.3|STANDARD_ERROR_OF_MEAN|43.83|||TWO_SIDED|95.0|-154.95|18.43||||||Month 36||18.43|-154.95|
71791153|NCT00861146|143080657|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Chi-squared|df = 1||||||<.01
71791154|NCT00861146|143080658|SUPERIORITY_OR_OTHER_LEGACY||mixed model regression analyses (F)|2.04|||>|0.15|||||||mixed model regression analyses|||Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).||||> .15
71791155|NCT00861146|143080659|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|df=1||||||<.001
71791156|NCT02981342|143080660|SUPERIORITY|||||||0.0495|||||||Cochran-Mantel-Haenszel|||||||0.0495
71791157|NCT02981342|143080660|SUPERIORITY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.0230
71791158|NCT02981342|143080661|SUPERIORITY|||||||0.0085|||||||Log Rank|||||||0.0085
71791159|NCT02981342|143080661|SUPERIORITY|||||||0.0123|||||||Log Rank|||||||0.0123
71791160|NCT02981342|143080662|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
71791161|NCT02981342|143080662|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
71838430|NCT04963270|143184678|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-18.7||||0.013|TWO_SIDED|95.0|-33.5|-3.9|||Cochran-Mantel-Haenszel|||||-3.9|-33.5|0.013
71791162|NCT02981342|143080667|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1
71791163|NCT02981342|143080667|SUPERIORITY|||||||0.3017|||||||Cochran-Mantel-Haenszel|||||||0.3017
71791164|NCT02981342|143080669|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.1938|TWO_SIDED|95.0|0.782|3.272|||Log Rank|||||3.272|0.782|0.1938
71791165|NCT02981342|143080669|SUPERIORITY||Hazard Ratio (HR)|1.533||||0.2477|TWO_SIDED|95.0|0.746|3.15|||Log Rank|||||3.150|0.746|0.2477
71791166|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.74||0.383|TWO_SIDED|95.0|-0.84|2.13|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||2.13|-0.84|0.383
71791167|NCT02981342|143080671|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.79||0.692|TWO_SIDED|95.0|-1.91|1.28|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours||1.28|-1.91|0.692
71791168|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.66||0.469|TWO_SIDED|95.0|-0.85|1.8|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.80|-0.85|0.469
71791169|NCT02981342|143080671|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.776|TWO_SIDED|95.0|-1.62|1.22|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours||1.22|-1.62|0.776
71791170|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.7||0.328|TWO_SIDED|95.0|-0.72|2.11|||Mixed Models Analysis|||Pain on the Average||2.11|-0.72|0.328
71791171|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.74||0.954|TWO_SIDED|95.0|-1.45|1.54|||Mixed Models Analysis|||Pain on the Average||1.54|-1.45|0.954
71791172|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.8||0.35|TWO_SIDED|95.0|-0.85|2.36|||Mixed Models Analysis|||Pain Right Now||2.36|-0.85|0.350
71791173|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.85||0.405|TWO_SIDED|95.0|-1.01|2.44|||Mixed Models Analysis|||Pain right now.||2.44|-1.01|0.405
71791174|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.73||0.565|TWO_SIDED|95.0|-1.06|1.91|||Mixed Models Analysis|||Pain Interfered General Activity||1.91|-1.06|0.565
71791175|NCT02981342|143080671|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.79||0.848|TWO_SIDED|95.0|-1.74|1.43|||Mixed Models Analysis|||Pain Interfered General Activity||1.43|-1.74|0.848
71791176|NCT02981342|143080671|SUPERIORITY||LSMean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.65||0.928|TWO_SIDED|95.0|-1.37|1.25|||Mixed Models Analysis|||Pain Interfered with Mood||1.25|-1.37|0.928
71791177|NCT02981342|143080671|SUPERIORITY||LSMean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.69||0.65|TWO_SIDED|95.0|-1.71|1.08|||Mixed Models Analysis|||Pain Interfered with Mood||1.08|-1.71|0.650
71791178|NCT02981342|143080671|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.865|TWO_SIDED|95.0|-1.89|1.6|||Mixed Models Analysis|||Pain Interfered Walking Ability||1.60|-1.89|0.865
71791179|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.92||0.497|TWO_SIDED|95.0|-1.23|2.5|||Mixed Models Analysis|||Pain Interfered Walking Ability||2.50|-1.23|0.497
71791180|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.8||0.272|TWO_SIDED|95.0|-0.72|2.5|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.50|-0.72|0.272
71838431|NCT04963270|143184679|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-22.0||||0.002|TWO_SIDED|95.0|-36.2|-7.9|||Cochran-Mantel-Haenszel|||||-7.9|-36.2|0.002
71791181|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.47|STANDARD_ERROR_OF_MEAN|0.85||0.583|TWO_SIDED|95.0|-1.25|2.19|||Mixed Models Analysis|||Pain Interfered with Normal Work||2.19|-1.25|0.583
71791182|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.82||0.876|TWO_SIDED|95.0|-1.53|1.79|||Mixed Models Analysis|||Pain Interfered with Relations||1.79|-1.53|0.876
71791183|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.88||0.644|TWO_SIDED|95.0|-1.37|2.19|||Mixed Models Analysis|||Pain Interfered with relations.||2.19|-1.37|0.644
71791184|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.85||0.384|TWO_SIDED|95.0|-0.97|2.48|||Mixed Models Analysis|||Pain Interfered with Sleep||2.48|-0.97|0.384
71791185|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.89||0.318|TWO_SIDED|95.0|-0.9|2.71|||Mixed Models Analysis|||||2.71|-0.90|0.318
71791186|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.97||0.407|TWO_SIDED|95.0|-1.15|2.78|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.78|-1.15|0.407
71791187|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.52|STANDARD_ERROR_OF_MEAN|1.04||0.62|TWO_SIDED|95.0|-1.58|2.62|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life||2.62|-1.58|0.620
71791188|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.475|TWO_SIDED|95.0|-0.9|1.91|||Mixed Models Analysis|||BPI-Mean Interference Score||1.91|-0.90|0.475
71838432|NCT04963270|143184680|SUPERIORITY||Difference in Adjusted Mean|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.57|-1.41|||ANCOVA and Conditional Mean Imputation|||||-1.41|-4.57|0.0002
71838433|NCT04963270|143184681|SUPERIORITY||Difference in Adjusted Mean|-3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-4.47|-1.53|||ANCOVA and Conditional Mean Imputation|||||-1.53|-4.47|<0.0001
71838434|NCT04963270|143184682|SUPERIORITY||Difference in Response Rate|-21.0||||0.004|TWO_SIDED|95.0|-35.4|-6.6|||Cochran-Mantel-Haenszel|||||-6.6|-35.4|0.004
71838435|NCT04963270|143184683|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-19.4||||0.005|TWO_SIDED|95.0|-32.8|-5.9|||Cochran-Mantel-Haenszel|||||-5.9|-32.8|0.005
71838436|NCT04963270|143184684|SUPERIORITY||Difference in Response Rate|-1.7||||0.847|TWO_SIDED|95.0|-19.4|15.9|||Cochran-Mantel-Haenszel|||||15.9|-19.4|0.847
71838437|NCT04963270|143184685|SUPERIORITY|Stratified Analysis|Difference in Response Rate|-4.3||||0.441|TWO_SIDED|95.0|-15.4|6.7|||Cochran-Mantel-Haenszel|||||6.7|-15.4|0.441
71838438|NCT04963270|143184686|SUPERIORITY||Difference in Response Rate|8.5||||0.115|TWO_SIDED|95.0|-2.1|19.0|||Cochran-Mantel-Haenszel|||||19|-2.1|0.115
71838439|NCT04963270|143184687|SUPERIORITY|Stratified Analysis|Difference in Response Rate|8.8||||0.077|TWO_SIDED|95.0|-1.0|18.6|||Cochran-Mantel-Haenszel|||||18.6|-1|0.077
71838440|NCT04963270|143184688|SUPERIORITY||Risk Difference|-6.77||||0.1314|TWO_SIDED|95.0|-17.25|3.7|||Cochran-Mantel-Haenszel|||||3.70|-17.25|0.1314
71838441|NCT04963270|143184689|SUPERIORITY|Stratified Analysis|Risk Difference|-5.07||||0.2264|TWO_SIDED|95.0|-14.74|4.61|||Cochran-Mantel-Haenszel|||||4.61|-14.74|0.2264
71892553|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.56|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|0.659|3.697||||||Comparison at 96 h post first dose||3.697|0.659|
71791189|NCT02981342|143080671|SUPERIORITY||LSMean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.74||0.54|TWO_SIDED|95.0|-1.04|1.96|||Mixed Models Analysis|||BPI-Mean Interference Score||1.96|-1.04|0.540
71791190|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-1.39|STANDARD_ERROR_OF_MEAN|5.98||0.818|TWO_SIDED|95.0|-13.46|10.68|||Mixed Models Analysis|||Global health status||10.68|-13.46|0.818
71791191|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-3.8|STANDARD_ERROR_OF_MEAN|6.06||0.533|TWO_SIDED|95.0|-16.03|8.42|||Mixed Models Analysis|||Global health status||8.42|-16.03|0.533
71791192|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|6.75||0.681|TWO_SIDED|95.0|-16.4|10.82|||Mixed Models Analysis|||Functional Scales: Physical functioning||10.82|-16.40|0.681
71791193|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-9.02|STANDARD_ERROR_OF_MEAN|6.75||0.189|TWO_SIDED|95.0|-22.63|4.59|||Mixed Models Analysis|||Functional Scales: Physical functioning||4.59|-22.63|0.189
71791194|NCT02981342|143080672|SUPERIORITY||LSMean Difference|0.96|STANDARD_ERROR_OF_MEAN|9.54||0.921|TWO_SIDED|95.0|-18.29|20.21|||Mixed Models Analysis|||Functional Scales: Role functioning||20.21|-18.29|0.921
71791195|NCT02981342|143080672|SUPERIORITY||LSMean Difference|0.01|STANDARD_ERROR_OF_MEAN|9.62||0.999|TWO_SIDED|95.0|-19.4|19.42|||Mixed Models Analysis|||Functional Scales: Role functioning.||19.42|-19.40|0.999
71791196|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-4.26|STANDARD_ERROR_OF_MEAN|6.91||0.541|TWO_SIDED|95.0|-18.2|9.68|||Mixed Models Analysis|||Functional Scales: Emotional functioning||9.68|-18.20|0.541
71791197|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-6.95|STANDARD_ERROR_OF_MEAN|7.05||0.33|TWO_SIDED|95.0|-21.17|7.27|||Mixed Models Analysis|||Functional Scales: Emotional functioning||7.27|-21.17|0.330
71791198|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-2.04|STANDARD_ERROR_OF_MEAN|6.29||0.747|TWO_SIDED|95.0|-14.74|10.66|||Mixed Models Analysis|||Functional Scales: Cognitive Functioning||10.66|-14.74|0.747
71791199|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-5.25|STANDARD_ERROR_OF_MEAN|6.43||0.419|TWO_SIDED|95.0|-18.22|7.73|||Mixed Models Analysis|||Functional Scales: Cognitive functioning||7.73|-18.22|0.419
71791200|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-4.02|STANDARD_ERROR_OF_MEAN|7.53||0.596|TWO_SIDED|95.0|-19.23|11.19|||Mixed Models Analysis|||Functional Scales: Social functioning||11.19|-19.23|0.596
71791201|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-19.12|STANDARD_ERROR_OF_MEAN|7.71||0.017|TWO_SIDED|95.0|-34.68|-3.55|||Mixed Models Analysis|||Functional Scales: Social functioning||-3.55|-34.68|0.017
71791202|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|7.57||0.919|TWO_SIDED|95.0|-16.03|14.49||Social Scales: Fatigue|Mixed Models Analysis|||Symptoms Scales: Fatigue||14.49|-16.03|0.919
71791203|NCT02981342|143080672|SUPERIORITY||LSMean Difference|8.48|STANDARD_ERROR_OF_MEAN|7.54||0.267|TWO_SIDED|95.0|-6.72|23.69|||Mixed Models Analysis|||Symptom Scales: Fatigue||23.69|-6.72|0.267
71791204|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-1.45|STANDARD_ERROR_OF_MEAN|8.54||0.866|TWO_SIDED|95.0|-18.66|15.77|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||15.77|-18.66|0.866
71791205|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-3.9|STANDARD_ERROR_OF_MEAN|8.59||0.652|TWO_SIDED|95.0|-21.23|13.43|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting||13.43|-21.23|0.652
71672208|NCT01575834|142862690|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.057|TWO_SIDED|95.0|0.57|0.97||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.97|0.57|0.057
71791206|NCT02981342|143080672|SUPERIORITY||LSMean Difference|7.11|STANDARD_ERROR_OF_MEAN|8.67||0.417|TWO_SIDED|95.0|-10.39|24.6|||Mixed Models Analysis|||Symptom Scales: Pain||24.60|-10.39|0.417
71791207|NCT02981342|143080672|SUPERIORITY||LSMean Difference|4.36|STANDARD_ERROR_OF_MEAN|8.69||0.618|TWO_SIDED|95.0|-13.16|21.89|||Mixed Models Analysis|||Symptom Scales: Pain||21.89|-13.16|0.618
71791208|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-10.84|STANDARD_ERROR_OF_MEAN|8.44||0.206|TWO_SIDED|95.0|-27.85|6.18|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||6.18|-27.85|0.206
71791209|NCT02981342|143080672|SUPERIORITY||LSMean Difference|4.86|STANDARD_ERROR_OF_MEAN|8.4||0.566|TWO_SIDED|95.0|-12.08|21.8|||Mixed Models Analysis|||Symptom Scales: Dyspnoea||21.80|-12.08|0.566
71791210|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-7.02|STANDARD_ERROR_OF_MEAN|7.93||0.38|TWO_SIDED|95.0|-23.01|8.96|||Mixed Models Analysis|||Symptom Scales: Insomnia||8.96|-23.01|0.380
71791211|NCT02981342|143080672|SUPERIORITY||LSMean Difference|1.52|STANDARD_ERROR_OF_MEAN|7.99||0.85|TWO_SIDED|95.0|-14.6|17.64|||Mixed Models Analysis|||Symptom Scales: Insomnia||17.64|-14.60|0.850
71791212|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-2.79|STANDARD_ERROR_OF_MEAN|8.91||0.756|TWO_SIDED|95.0|-20.78|15.21|||Mixed Models Analysis|||Symptom Scales: Appetite loss||15.21|-20.78|0.756
71791213|NCT02981342|143080672|SUPERIORITY||LSMean Difference|3.02|STANDARD_ERROR_OF_MEAN|9.31||0.747|TWO_SIDED|95.0|-15.77|21.82|||Mixed Models Analysis|||Symptom Scales: Appetite loss||21.82|-15.77|0.747
71672209|NCT01575834|142862691|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.52|0.87||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.87|0.52|0.096
71672210|NCT01575834|142862692|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.44|1.02||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.02|0.44|0.096
71672211|NCT01575834|142862693|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.096|TWO_SIDED|95.0|0.49|0.91||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab|||0.91|0.49|0.096
71791214|NCT02981342|143080672|SUPERIORITY||LSMean Difference|9.47|STANDARD_ERROR_OF_MEAN|9.23||0.311|TWO_SIDED|95.0|-9.16|28.09|||Mixed Models Analysis|||Symptom Scales: Constipation||28.09|-9.16|0.311
71791215|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-9.97|STANDARD_ERROR_OF_MEAN|9.3||0.29|TWO_SIDED|95.0|-28.75|8.8|||Mixed Models Analysis|||Symptom Scales: Constipation||8.80|-28.75|0.290
71838442|NCT04963270|143184690|SUPERIORITY||Difference in Adjusted Mean|3.44|STANDARD_ERROR_OF_MEAN|1.45||0.0179|TWO_SIDED|95.0|0.59|6.29|||ANCOVA and Conditional Mean Imputation|||||6.29|0.59|0.0179
71791216|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-10.57|STANDARD_ERROR_OF_MEAN|10.58||0.323|TWO_SIDED|95.0|-31.93|10.78|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||10.78|-31.93|0.323
71791217|NCT02981342|143080672|SUPERIORITY||LSMean Difference|-4.8|STANDARD_ERROR_OF_MEAN|10.54||0.651|TWO_SIDED|95.0|-26.08|16.48|||Mixed Models Analysis|||Symptom Scales: Diarrhoea||16.48|-26.08|0.651
71791218|NCT02981342|143080672|SUPERIORITY||LSMean Difference|1.51|STANDARD_ERROR_OF_MEAN|7.47||0.841|TWO_SIDED|95.0|-13.57|16.59|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||16.59|-13.57|0.841
71791219|NCT02981342|143080672|SUPERIORITY||LSMean Difference|7.26|STANDARD_ERROR_OF_MEAN|7.57||0.344|TWO_SIDED|95.0|-8.03|22.54|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties||22.54|-8.03|0.344
71791220|NCT03045887|143080739|OTHER||Ratio|0.41|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.27|0.61|||||AUC(0-t). Standard error of mean was on logged scale|||0.61|0.27|
71791221|NCT03045887|143080739|OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|90.0|0.65|1.47|||||AUC(0-t).Standard error of mean was on logged scale|||1.47|0.65|
71791222|NCT03045887|143080739|OTHER||Ratio|1.33|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|1.01|1.74|||||AUC(0-t).Standard error of mean was on logged scale|||1.74|1.01|
71791223|NCT03045887|143080739|OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|0.69|1.62|||||AUC(0-t).Standard error of mean was on logged scale|||1.62|0.69|
71791224|NCT03045887|143080739|OTHER||Ratio|1.25|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|0.95|1.64|||||AUC(0-t).Standard error of mean was on logged scale|||1.64|0.95|
71791225|NCT03045887|143080740|OTHER||Ratio|1.22|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|90.0|1.01|1.47|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented|||1.47|1.01|
71791226|NCT03045887|143080741|OTHER||ratio|0.78|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.61|0.99||||||||0.99|0.61|
71791227|NCT03045887|143080741|OTHER||ratio|0.96|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|90.0|0.75|1.22||||||||1.22|0.75|
71791228|NCT03045887|143080741|OTHER||ratio|0.81|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.68|0.97||||||||0.97|0.68|
71791229|NCT03045887|143080741|OTHER||ratio|0.66|STANDARD_ERROR_OF_MEAN|0.154|||TWO_SIDED|90.0|0.51|0.86||||||||0.86|0.51|
71791230|NCT03045887|143080741|OTHER||ratio|0.76|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|90.0|0.63|0.9||||||||0.90|0.63|
71791231|NCT03045887|143080742|OTHER||ratio|1.14|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|0.96|1.36|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented|||1.36|0.96|
71791232|NCT03045887|143080748|OTHER||Ratio|2.06|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|1.67|2.55|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.|||2.55|1.67|
71791233|NCT03226392|143080751|SUPERIORITY||Mean Difference (Net)|-0.031||||0.214|TWO_SIDED|95.0|-0.08|0.018|||ANCOVA|||||0.018|-0.080|0.214
71791234|NCT03226392|143080752|SUPERIORITY||Mean Difference (Net)|-0.1||||0.035|TWO_SIDED|0.035|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.035
71791235|NCT03226392|143080753|SUPERIORITY||Mean Difference (Net)|0.093||||0.893|TWO_SIDED|95.0|-0.2|0.17|||ANCOVA|||||0.17|-0.20|0.893
71791236|NCT03226392|143080754|SUPERIORITY||Mean Difference (Net)|0.061||||0.448|TWO_SIDED|95.0|-0.07|0.17|||ANCOVA|||||0.17|-0.07|0.448
71791237|NCT01086540|143080763|SUPERIORITY||Median Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|14.71||0.12|TWO_SIDED||||||Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|The null hypothesis was that the mean change in 6MWD between baseline and Week 24 does not differ between rituximab and placebo. A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 24.||||0.12
71791238|NCT01086540|143080764|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with PVR as the outcome and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
71892554|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.608|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.433|0.853||||||Comparison at 6 h post first dose||0.853|0.433|
71672212|NCT01575834|142862694|SUPERIORITY||Odds Ratio (OR)|0.28||||0.096|TWO_SIDED|95.0|0.17|0.49||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.49|0.17|0.096
71791239|NCT01086540|143080765|SUPERIORITY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|15.1||0.28|TWO_SIDED|||||Week 48 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.28
71791240|NCT01086540|143080765|SUPERIORITY||Mean Difference (Final Values)|25.1|STANDARD_ERROR_OF_MEAN|11.5||0.031|TWO_SIDED|||||Week 24 value. P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 24.|A repeated measures random effect model was fit to model the distance walked as a function of treatment, visit week, a treatment by visit week interaction, and a quadratic visit term. A random slope and intercept were fit for each participant using a separate unstructured covariance matrix for each treatment group. The model included all available data up to Week 48.||||0.031
71791241|NCT01086540|143080766|SUPERIORITY|||||||0.92||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to clinical worsening were compared using a log-rank test.||||0.92
71791242|NCT01086540|143080767|SUPERIORITY|||||||0.36||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to change or addition of PAH medications were compared using a log-rank test.||||0.36
71791243|NCT01086540|143080768|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.7||0.81|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the mental component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.81
71791244|NCT01086540|143080769|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|2.1||0.3|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with the physical component score as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.30
71791245|NCT01086540|143080770|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.58|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with HAQ-DI as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.58
71791246|NCT01086540|143080771|SUPERIORITY|||||||0.47||||||P-values not adjusted for multiple comparisons.|Regression, Linear|||A Poisson model was used to describe the rate of new digital ulcers (per week) as the outcome with treatment, number of digital ulcers at Baseline, and if the measurement was affected by changed or new PAH therapeutic agents as covariates.||||0.47
71791247|NCT01086540|143080772|SUPERIORITY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|5.7||0.43|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with severity of Raynaud's (0 to 100) as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.43
71838443|NCT04963270|143184691|SUPERIORITY|Stratified Analysis|Difference in Adjusted Mean|3.73|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|1.04|6.42|||ANCOVA and Conditional Mean Imputation|||||6.42|1.04|0.0066
71838444|NCT04026555|143184701|SUPERIORITY||Risk Ratio (RR)|1.43|||<|0.001|TWO_SIDED|95.0|1.16|1.78|||Regression, Poisson|||IPTW Poisson regression was used to model the number of escalations per visit with an offset of the log transformed length of stay normalized per 1000 bed days. Treatment effect is expressed in terms of adjusted incidence rate ratio (IRR) per 1000 patient bed days.||1.78|1.16|< 0.001
71791248|NCT01086540|143080773|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.8||0.65|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis||Estimate is for the difference (Rituximab - Placebo) at Week 48.|A repeated measures random effect model was fit with DLCO as the outcome, and treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.65
71791249|NCT01086540|143080775|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|9.7||0.42|TWO_SIDED|||||P-values not adjusted for multiple comparisons.|Mixed Models Analysis|||A repeated measures mixed model was fit with percent change in PVR as the outcome and baseline PVR, treatment, visit week (actual observed week), and their interaction as predictors. Random intercepts and slopes were fit for each participant using an unstructured covariance structure for each treatment group.||||0.42
71672213|NCT01575834|142862695|SUPERIORITY||Odds Ratio (OR)|0.26||||0.096|TWO_SIDED|95.0|0.16|0.41||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test|Values \< 1 for odds ratio favor romosozumab.|||0.41|0.16|0.096
71672214|NCT01575834|142862696|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.18|TWO_SIDED|95.0|0.22|1.35||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.35|0.22|0.18
71791250|NCT01086540|143080780|SUPERIORITY|||||||0.17||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.17
71791251|NCT01086540|143080781|SUPERIORITY|||||||0.35||||||P-values not adjusted for multiple comparisons.|Log Rank|||Kaplan-Meier curves for time to all-cause mortality were compared using a log-rank test.||||0.35
71791252|NCT03164928|143080782|SUPERIORITY||Least Squares Mean Difference|0.11||||0.68|TWO_SIDED|95.0|-0.45|0.673|||ANCOVA|||||0.673|-0.450|0.68
71791253|NCT03164928|143080783|SUPERIORITY||Least Squares Mean Difference|0.17||||0.34|TWO_SIDED|95.0|-0.194|0.542|||Repeated Measures Model|||Month 6||0.542|-0.194|0.34
71791254|NCT03164928|143080783|SUPERIORITY||Least Squares Mean Difference|0.03||||0.93|TWO_SIDED|95.0|-0.609|0.661|||Repeated Measures Model|||Month 18||0.661|-0.609|0.93
71791255|NCT03164928|143080783|SUPERIORITY||Least Squares Mean Difference|0.11||||0.74|TWO_SIDED|95.0|-0.572|0.795|||Repeated Measures Model|||Month 24||0.795|-0.572|0.74
71791256|NCT03164928|143080783|SUPERIORITY||Least Squares Means Difference|-0.8||||0.12|TWO_SIDED|95.0|-1.848|0.239|||Repeated Measures Model|||Month 36||0.239|-1.848|0.12
71791257|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|-0.41||||0.19|TWO_SIDED|95.0|-1.05|0.223|||Repeated Measures Model|||Month 6 (Total Hip)||0.223|-1.050|0.19
71791258|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.83|TWO_SIDED|95.0|-0.631|0.515|||Repeated Measures Model|||Month 12 (Total Hip)||0.515|-0.631|0.83
71791259|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|-0.27||||0.51|TWO_SIDED|95.0|-1.108|0.565|||Repeated Measures Model|||Month 18 (Total Hip)||0.565|-1.108|0.51
71791260|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.69|TWO_SIDED|95.0|-1.098|0.746|||Repeated Measures Model|||Month 24 (Total Hip)||0.746|-1.098|0.69
71791261|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|-0.09||||0.89|TWO_SIDED|95.0|-1.465|1.286|||Repeated Measures Model|||Month 36 (Total Hip)||1.286|-1.465|0.89
71791262|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|-0.18||||0.64|TWO_SIDED|95.0|-0.969|0.614|||Repeated Measures Model|||Month 6 (Femoral Neck)||0.614|-0.969|0.64
71791263|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|0.1||||0.83|TWO_SIDED|95.0|-0.808|1.0|||Repeated Measures Model|||Month 12 (Femoral Neck)||1.000|-0.808|0.83
71791264|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|0.37||||0.48|TWO_SIDED|95.0|-0.697|1.442|||Repeated Measures Model|||Month 18 (Femoral Neck)||1.442|-0.697|0.48
71791265|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|0.11||||0.86|TWO_SIDED|95.0|-1.222|1.443|||Repeated Measures Model|||Month 24 (Femoral Neck)||1.443|-1.222|0.86
71791266|NCT03164928|143080784|SUPERIORITY||Least Squares Mean Difference|0.38||||0.66|TWO_SIDED|95.0|-1.378|2.13|||Repeated Measures Model|||Month 36 (Femoral Neck)||2.130|-1.378|0.66
71791267|NCT04949165|143080824|NON_INFERIORITY|The study employed a non-inferiority design with a non-inferiority margin of 1 g/dL for haemoglobin levels at 4 months, a 1-sided alpha level of 0.025, at least 85% power and under the assumption that the true difference in the means was 0.3 g/dL. The estimated sample size also allowed for up to 10% loss to follow- up or iron supplementation for those initially not requiring supplements, thus the sample size was 292.||||||0.025||||||Non-inferiority threshold of -1 g/dL for the lower bound of the 97.5% CI.|t-test, 1 sided|||||||0.025
71791268|NCT00894322|143080873|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.269||0.0013|TWO_SIDED|95.0|-1.5|-0.4||Treatment group and HbA1c stratum at screening were factors. Placebo was reference group.|ANOVA|||||-0.40|-1.50|0.0013
71791269|NCT00894322|143080874|SUPERIORITY_OR_OTHER|||||||0.0033|||||||Cochran-Mantel-Haenszel|Adjusted for HbA1c strata at screening.||||||0.0033
71791270|NCT00894322|143080875|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.835||0.2285|TWO_SIDED|95.0|-2.73|0.68|||ANOVA|treatment group and HbA1c stratum at screening were factors.||Least square mean (LS) mean, 95% confidence interval (CI) and p-value calculated for the changes in weight from baseline in participants in cohort 2 treated with exenatide with placebo as reference group.||0.68|-2.73|0.2285
71791271|NCT00894322|143080876|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|STANDARD_ERROR_OF_MEAN|12.8||0.0035|TWO_SIDED|95.0|-66.5|-14.3|||ANOVA|treatment group and HbA1c stratum at screening were factors.||||-14.3|-66.5|0.0035
71791272|NCT04262232|143080900|SUPERIORITY||Mean Difference (Net)|-1.8||||0.0001|TWO_SIDED|95.0|-2.6|-0.95|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.95|-2.6|0.0001
71791273|NCT04262232|143080901|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.0001|TWO_SIDED|95.0|1.17|1.63|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||1.63|1.17|<0.0001
71791274|NCT04262232|143080903|SUPERIORITY||Mean Difference (Net)|-2.8||||0.01|TWO_SIDED|95.0|-4.99|-0.61|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||-0.61|-4.99|0.01
71791275|NCT04262232|143080905|SUPERIORITY||Mean Difference (Net)|0.5||||0.51|TWO_SIDED|95.0|-1.02|2.02|||Paired t-test, two-sided||Baseline value minus two weeks post-intervention value.|||2.02|-1.02|0.51
71791276|NCT01975909|143080906|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.||||||0.29|||||||t-test, 2 sided|||||||0.29
71791277|NCT01975909|143080907|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.47|||||||t-test, 2 sided|||||||0.47
71791278|NCT01975909|143080908|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.||||||0.12|||||||t-test, 2 sided|||||||0.12
71791279|NCT01975909|143080909|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.69|||||||t-test, 2 sided|||||||0.69
71791280|NCT01975909|143080910|EQUIVALENCE|We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.||||||0.009|||||||t-test, 2 sided|||||||0.009
71791281|NCT01975909|143080911|EQUIVALENCE|We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.||||||0.18|||||||t-test, 2 sided|||||||0.18
71791282|NCT01466348|143080996|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.6||||0.0008|TWO_SIDED|95.0|1.5|5.6|||ANOVA|No baseline covariate adjustment was carried out.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.6|1.5|0.0008
71791283|NCT01466348|143080997|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.5|||<|0.0001|TWO_SIDED|95.0|4.5|8.4|||ANOVA|No baseline covariate adjustment was applied.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||8.4|4.5|<0.0001
71791284|NCT03989440|143081018|SUPERIORITY||LS Mean Difference|0.54||||0.59|TWO_SIDED|95.0|-1.48|2.55|||Mixed Models Analysis|||||2.55|-1.48|0.59
71791285|NCT03989440|143081019|SUPERIORITY||LS Mean Difference|-1.56||||0.13|TWO_SIDED|95.0|-3.62|0.5|||Mixed Models Analysis|||||0.50|-3.62|0.13
71791286|NCT03989440|143081020|SUPERIORITY||LS Mean Difference|-1.16||||0.16|TWO_SIDED|95.0|-2.81|0.5|||Mixed Models Analysis|||||0.50|-2.81|0.16
71791287|NCT03989440|143081021|SUPERIORITY||% Difference in responder rate|-9.3||||0.68|TWO_SIDED|95.0|-43.3|25.4|||Fisher Exact|||||25.4|-43.3|0.68
71838445|NCT04026555|143184702|SUPERIORITY||Risk Ratio (RR)|1.74|||<|0.001|TWO_SIDED|95.0|1.39|2.18||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regres- sion models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||2.18|1.39|<0.001
71838446|NCT04026555|143184705|SUPERIORITY||Risk Ratio (RR)|0.76||||0.045|TWO_SIDED|95.0|0.58|0.99||Correction for multiple comparisons was performed on all key outcomes within the primary and secondary hypotheses, respectively, using the false discovery rate method (FDR).|Regression, Logistic|||IPTW log-binomial regression models were used to model the secondary and ad hoc outcomes. Treatment effect is expressed as adjusted relative risk (RR).||0.99|0.58|0.045
71838447|NCT04026555|143184710|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.14|TWO_SIDED|95.0|0.98|1.18|||Regression, Cox|||||1.18|0.98|0.14
71838448|NCT04636528|143184743|EQUIVALENCE|A minimal detectable difference of 11.2 points was selected based on the psychometric properties of the scale. Considering a power of 80%, a 2-sided 0.05 significance level, and a 10% dropout rate, 82 patients would be necessary to detect an 11.2-point difference between the 2 groups.|Median Difference (Net)|-1.8||||0.75|TWO_SIDED|95.0|-13.5|9.8||The threshold for statistical significance was set at 0.05.|quantile mixed-effects model|a robust method on the medians||||9.8|-13.5|0.75
71838449|NCT04636528|143184743|EQUIVALENCE||Odds Ratio (OR)|0.84||||0.71|TWO_SIDED|95.0|0.32|2.16||The threshold for statistical significance was set at 0.05.|Regression, Logistic|||||2.16|0.32|0.71
71838450|NCT04636528|143184744|EQUIVALENCE||Median Difference (Net)|-0.6||||0.12|TWO_SIDED|95.0|-1.4|-0.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.2|-1.4|0.12
71838451|NCT04636528|143184745|EQUIVALENCE||Median Difference (Net)|-2.2||||0.89|TWO_SIDED|95.0|-34.6|30.2||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|||||30.2|-34.6|0.89
71838452|NCT04636528|143184746|EQUIVALENCE||Median Difference (Net)|-0.3||||0.51|TWO_SIDED|95.0|-1.0|0.5|||Quantile mixed-effects model|a robust method on the medians||||0.5|-1.0|0.51
71838453|NCT04636528|143184747|EQUIVALENCE||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|t-test, 2 sided|||||||<0.001
71838454|NCT04636528|143184748|EQUIVALENCE||Median Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|0.6||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||0.6|-1.5|<.001
71838455|NCT04636528|143184749|EQUIVALENCE||Median Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.4|-0.5||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|a robust method on the medians||||-0.5|-1.4|<.001
71791288|NCT01955161|143081071|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.47||0.9591|TWO_SIDED|95.0|-0.59|1.26||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.26|-0.59|0.9591
71791289|NCT01955161|143081071|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.47||1|TWO_SIDED|95.0|-0.88|0.98||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.98|-0.88|1.000
71791290|NCT01955161|143081072|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.37|1.21||Corrected for multiplicity according toe the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.21|-1.37|1.000
71791291|NCT01955161|143081072|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.29|1.31||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||1.31|-1.29|1.000
71838456|NCT04636528|143184750|EQUIVALENCE||Median Difference (Net)|-0.5||||0.27|TWO_SIDED|95.0|-1.3|0.4||The threshold for statistical significance was set at 0.05.|Quantile mixed-effects model|A robust method on the medians.||||0.4|-1.3|.27
71838457|NCT04636528|143184751|EQUIVALENCE||Difference in proportions|11.8||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
71838458|NCT04636528|143184752|EQUIVALENCE||Mean Difference (Final Values)|12.7|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71838459|NCT04636528|143184753|EQUIVALENCE||Mean Difference (Final Values)|67.7||||0.36|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.36
71838460|NCT04636528|143184754|EQUIVALENCE||Mean Difference (Final Values)|1.62|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71838461|NCT06321809|143184756|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses.||total scale score comparison||||0.24
71838462|NCT06321809|143184756|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.001
71672215|NCT01575834|142862697|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.12|TWO_SIDED|95.0|0.24|1.04||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||1.04|0.24|0.12
71838463|NCT06321809|143184756|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.03
71838464|NCT06321809|143184756|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||total scale score comparison||||0.003
71838465|NCT06321809|143184757|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Weight comparison||||0.08
71838466|NCT06321809|143184758|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||BMI Comparison||||0.13
71838467|NCT06321809|143184759|SUPERIORITY|||||||0.63|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||Waist Circumference Comparison||||0.63
71838468|NCT06321809|143184760|SUPERIORITY|||||||0.89|||||||Kruskal-Wallis|A significance level of p\<0.05 was used for all analyses||LDL Cholesterol Comparison||||0.89
71838469|NCT01369355|143184771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.040
71672216|NCT01575834|142862698|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.012|TWO_SIDED|95.0|0.4|0.9|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.90|0.40|0.012
71791292|NCT01955161|143081073|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.15|0.2||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.20|-0.15|1.000
71791293|NCT01955161|143081073|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.34|0.02||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.||0.02|-0.34|1.000
71791294|NCT01245270|143081082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||"For the incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed.~Values obtained following the control and extract capsules were compared by paired t-tests."|t-test, 2 sided|||||||0.003
71791295|NCT01245270|143081083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||95.0||||For incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed. Values obtained following the control and extract capsules were compared by paired t-tests.|t-test, 2 sided|||||||0.028
71791296|NCT02432846|143081119|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.978||||0.964|TWO_SIDED|95.0|0.371|2.579|||Log Rank|||||2.579|0.371|0.964
71791297|NCT02432846|143081119|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.619||||0.163|TWO_SIDED|95.0|0.314|1.222|||Log Rank|||||1.222|0.314|0.163
71791298|NCT02432846|143081119|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.732||||0.25|TWO_SIDED|95.0|0.421|1.27|||Log Rank|||||1.270|0.421|0.250
71791299|NCT02432846|143081120|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.756||||0.596|TWO_SIDED|95.0|0.268|2.134|||Log Rank|||||2.134|0.268|0.596
71791300|NCT02432846|143081120|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.661||||0.285|TWO_SIDED|95.0|0.308|1.418|||Log Rank|||||1.418|0.308|0.285
71791301|NCT02432846|143081120|OTHER|Exploratory superiority (non-powered)|Hazard Ratio (HR)|0.699||||0.24|TWO_SIDED|95.0|0.378|1.29|||Log Rank|||||1.290|0.378|0.240
71791302|NCT02432846|143081121|OTHER|Exploratory superiority (non-powered)|||||=|0.812|||||||Log Rank|||||||= 0.812
71791303|NCT02432846|143081122|OTHER|Exploratory superiority (non-powered)|||||=|0.861|||||||Log Rank|||||||= 0.861
71791304|NCT01770379|143081134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.2001|TWO_SIDED|95.0|0.79|3.03|||Regression, Logistic|||||3.03|0.79|0.2001
71838470|NCT01369355|143184771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.005
71838471|NCT01369355|143184772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.033
71838472|NCT01369355|143184772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.018
71892555|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.674|STANDARD_ERROR_OF_MEAN|0.217|||TWO_SIDED|95.0|0.437|1.039||||||Comparison at 12 h post first dose||1.039|0.437|
71892556|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.613|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|95.0|0.374|1.004||||||Comparison at 18 h post first dose||1.004|0.374|
71791305|NCT01770379|143081134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1574|TWO_SIDED|95.0|0.83|3.15|||Regression, Logistic|||||3.15|0.83|0.1574
71791306|NCT01912287|143081140|SUPERIORITY||Odds Ratio (OR)|2.46||||0.03|TWO_SIDED|95.0|1.12|5.42|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. SE at post-treatment||5.42|1.12|.03
71892557|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.558|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.338|0.921||||||Comparison at 24 h post first dose||0.921|0.338|
71892558|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|95.0|0.427|1.23||||||Comparison at 48 h post first dose||1.230|0.427|
71892559|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.73|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.384|1.386||||||Comparison at 72 h post first dose||1.386|0.384|
71892560|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.147|STANDARD_ERROR_OF_MEAN|0.359|||TWO_SIDED|95.0|0.559|2.353||||||Comparison at 96 h post first dose||2.353|0.559|
71892561|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.776|STANDARD_ERROR_OF_MEAN|0.167|||TWO_SIDED|95.0|0.556|1.082||||||Comparison at 6 h post first dose||1.082|0.556|
71892562|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.602|STANDARD_ERROR_OF_MEAN|0.212|||TWO_SIDED|95.0|0.394|0.919||||||Comparison at 12 h post first dose||0.919|0.394|
71672217|NCT01575834|142862699|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.002|TWO_SIDED|95.0|0.46|0.84|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio \< 1 favors romosozumab.|||0.84|0.46|0.002
71791307|NCT01912287|143081140|SUPERIORITY||Odds Ratio, log|5.0|||<|0.001|TWO_SIDED|95.0|2.12|11.82|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of CBT vs. SE at post-treatment||11.82|2.12|<.001
71791308|NCT01912287|143081140|SUPERIORITY||Odds Ratio (OR)|0.49||||0.07|TWO_SIDED|95.0|0.24|1.03|||Generalized Linear Mixed Models|||This comparison is from the Generalized Linear Mixed Models (GLMM) analysis using a quadratic growth curve over time. This comparison is at post-treatment. Note, although all 3 groups are included in the GLMM, this statistical test specifically compares response rates of KY vs. CBT at post-treatment||1.03|0.24|0.07
71791309|NCT03914326|143081145|SUPERIORITY|Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.|Hazard Ratio (HR)|0.86||||0.0028|TWO_SIDED|95.0|0.77|0.96|||Regression, Cox|||||0.96|0.77|0.0028
71791310|NCT02357901|143081173|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
71791311|NCT02357901|143081173|SUPERIORITY||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test|||||||<0.0001
71791312|NCT02357901|143081174|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
71791313|NCT02357901|143081174|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel|||||||<0.0001
71791314|NCT02357901|143081175|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
71791315|NCT02357901|143081175|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
71791316|NCT02357901|143081176|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
71838473|NCT01369355|143184773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.189
71838474|NCT01369355|143184773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.||||||0.007
71672218|NCT01575834|142862700|SUPERIORITY||Odds Ratio (OR)|0.11||||0.011|TWO_SIDED|95.0|0.01|0.87|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.87|0.01|0.011
71791317|NCT02357901|143081176|SUPERIORITY||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test|||||||<0.0001
71791318|NCT02357901|143081177|SUPERIORITY||LSM difference|-9.4|STANDARD_ERROR_OF_MEAN|2.62||0.0003|TWO_SIDED|95.0|-14.56|-4.3||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-4.30|-14.56|0.0003
71791319|NCT02357901|143081177|SUPERIORITY||LSM difference|-12.4|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-17.51|-7.28||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-7.28|-17.51|<0.0001
71838475|NCT01369355|143184774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.035
71838476|NCT01369355|143184774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.||||||0.004
71892563|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.623|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|0.386|1.007||||||Comparison at 18 h post first dose||1.007|0.386|
71791320|NCT02357901|143081178|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
71791321|NCT02357901|143081178|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
71791322|NCT02357901|143081179|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
71791323|NCT02357901|143081179|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
71791324|NCT02357901|143081180|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.96|-0.46||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.46|-0.96|<0.0001
71791325|NCT02357901|143081180|SUPERIORITY||LSM difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.12|-0.62||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.62|-1.12|<0.0001
71892564|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.429|STANDARD_ERROR_OF_MEAN|0.245|||TWO_SIDED|95.0|0.263|0.7||||||Comparison at 24 h post first dose||0.700|0.263|
71892565|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.502|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|0.299|0.842||||||Comparison at 48 h post first dose||0.842|0.299|
71892566|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.479|STANDARD_ERROR_OF_MEAN|0.317|||TWO_SIDED|95.0|0.255|0.903||||||Comparison at 72 h post first dose||0.903|0.255|
71791326|NCT02357901|143081181|SUPERIORITY||LSM difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.89|-0.33||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.33|-0.89|<0.0001
71791327|NCT02357901|143081181|SUPERIORITY||LSM difference|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.41||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.41|-0.97|<0.0001
71791328|NCT02357901|143081182|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.3143|TWO_SIDED|95.0|-1.13|0.36||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.36|-1.13|0.3143
71791329|NCT02357901|143081182|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.38||0.0101|TWO_SIDED|95.0|-1.72|-0.23||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.23|-1.72|0.0101
71791330|NCT02357901|143081183|SUPERIORITY||LSM difference|-1.6|STANDARD_ERROR_OF_MEAN|0.87||0.0726|TWO_SIDED|95.0|-3.29|0.14||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||0.14|-3.29|0.0726
71791331|NCT02357901|143081183|SUPERIORITY||LSM difference|-2.6|STANDARD_ERROR_OF_MEAN|0.87||0.0028|TWO_SIDED|95.0|-4.32|-0.9||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.||-0.90|-4.32|0.0028
71791332|NCT02357901|143081184|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.81|9.2||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.20|5.81|<0.0001
71791333|NCT02357901|143081184|SUPERIORITY||LSM difference|7.5|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|5.82|9.21||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.||||9.21|5.82|<0.0001
71791334|NCT04788953|143081188|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects tobit regression model (censored normal). Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||The statistical null hypothesis was that solriamfetol does not improve change in MWT scores versus placebo after 4 weeks of treatment (H0: µsol - µpl ≤ 0). Study was designed to have 97% power to detect a difference of 5.7 minutes or greater on MWT sleep latency (α=0.05, assumed σ=7.2) with 100 participants. Blinded interim power analysis on the baseline data conducted in October 2023 indicated the trial would have \>99% power to detect a similar difference with only 74 participants.||||<0.001
71791335|NCT04788953|143081189|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol, Placebo), visit (Baseline, End-of-Treatment), trial (1-4) main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
71791336|NCT04788953|143081190|SUPERIORITY|||||||0.01||||||"Chi-squared tests performed on dichotomized CGI-Change data (Improved \[very much improved, much improved, minimally improved\] vs. Not Improved \[no change, minimally worse, much worse, very much worse\])."|Chi-squared|P-value is difference between groups.||||||0.01
71791337|NCT04788953|143081192|SUPERIORITY|Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.||||||0.02|||||||Mixed Models Analysis|P-value is difference between groups.||||||0.02
71791338|NCT04788953|143081193|SUPERIORITY|||||||0.64||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.64
71791339|NCT04788953|143081194|SUPERIORITY|||||||0.04||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.04
71791340|NCT04788953|143081195|SUPERIORITY|||||||0.61||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.61
71791341|NCT04788953|143081196|SUPERIORITY|||||||0.57||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and Condition (Baseline vs. Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||0.57
71791342|NCT04788953|143081197|SUPERIORITY||||||<|0.001||||||Change from baseline using mixed-effects linear regression model. Group (Solriamfetol vs. Placebo) and visit (Baseline vs. End-of-Treatment) as main factors and their interactions. Covariates considered: age, sex, ethnicity, race.|Mixed Models Analysis|P-value is difference between groups.||||||<0.001
71791343|NCT02293655|143081199|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|2.6||0.55|TWO_SIDED||||||t-test, 2 sided|||Compared at Baseline Time point||||0.55
71791344|NCT02293655|143081199|SUPERIORITY||Mean Difference (Final Values)|2.41|STANDARD_ERROR_OF_MEAN|2.3||0.3|TWO_SIDED||||||t-test, 2 sided|||Comparison at MPH Maintenance Visit (Week 8)||||.30
71791345|NCT02293655|143081199|SUPERIORITY||Mean Difference (Final Values)|4.01|STANDARD_ERROR_OF_MEAN|3.9||0.28|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (Week 9)||||.28
71672219|NCT01575834|142862701|SUPERIORITY||Odds Ratio (OR)|0.06|||<|0.001|TWO_SIDED|95.0|0.01|0.44|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values \< 1 for odds ratio favor romosozumab.|||0.44|0.01|< 0.001
71791346|NCT02293655|143081199|SUPERIORITY||Mean Difference (Final Values)|9.64|STANDARD_ERROR_OF_MEAN|2.5||0|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (Week 10)||||.00
71791347|NCT02293655|143081199|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|3.2||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (Week 12)||||.01
71791348|NCT02293655|143081200|SUPERIORITY||Mean Difference (Final Values)|36.04|STANDARD_ERROR_OF_MEAN|25.4||0.32|TWO_SIDED||||||t-test, 2 sided|||Compared at baseline timepoint||||.32
71791349|NCT02293655|143081200|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|30.1||0.9|TWO_SIDED||||||t-test, 2 sided|||Compared at Maintenance Time Point (week 8)||||.90
71791350|NCT02293655|143081200|SUPERIORITY||Mean Difference (Final Values)|100.81|STANDARD_ERROR_OF_MEAN|37.5||0.007|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 1 (week 9)||||.007
71791351|NCT02293655|143081200|SUPERIORITY||Mean Difference (Final Values)|49.07|STANDARD_ERROR_OF_MEAN|56.6||0.26|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 2 (week 10)||||.26
71791352|NCT02293655|143081200|SUPERIORITY||Mean Difference (Final Values)|123.9|STANDARD_ERROR_OF_MEAN|37.6||0.01|TWO_SIDED||||||t-test, 2 sided|||Compared at Randomization Phase 3 (week 12)||||.01
71791353|NCT02293655|143081201|SUPERIORITY||Mean Difference (Final Values)|31.13|STANDARD_ERROR_OF_MEAN|32.9||0.33|TWO_SIDED||||||t-test, 2 sided|||Comparison at Baseline||||.33
71791354|NCT02293655|143081201|SUPERIORITY||Mean Difference (Final Values)|56.86|STANDARD_ERROR_OF_MEAN|29.5||0.06|TWO_SIDED||||||t-test, 2 sided|||Comparison at Maintenance (week 8)||||.06
71791355|NCT02293655|143081201|SUPERIORITY||Mean Difference (Final Values)|108.78|STANDARD_ERROR_OF_MEAN|46.8||0.05|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 1 (week 9)||||.05
71791356|NCT02293655|143081201|SUPERIORITY||Mean Difference (Final Values)|118.12|STANDARD_ERROR_OF_MEAN|44.2||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 2 (week 10)||||.008
71791357|NCT02293655|143081201|SUPERIORITY||Mean Difference (Final Values)|77.09|STANDARD_ERROR_OF_MEAN|42.9||0.07|TWO_SIDED||||||t-test, 2 sided|||Comparison at Randomization Phase 3 (week 12)||||.07
71791358|NCT03814746|143081218|SUPERIORITY||Rate ratio|1.08|||>|0.999|TWO_SIDED|95.0|0.76|1.55|||negative binomial regression model|||||1.55|0.76|> 0.999
71791359|NCT03814746|143081218|SUPERIORITY||Rate ratio|0.89|||>|0.999|TWO_SIDED|95.0|0.62|1.27|||negative binomial regression model|||||1.27|0.62|> 0.999
71791360|NCT03814746|143081219|SUPERIORITY||Rate ratio|1.21|||||TWO_SIDED|95.0|0.87|1.7|||negative binomial regression model|||||1.70|0.87|
71791361|NCT03814746|143081219|SUPERIORITY||Rate ratio|0.83|||||TWO_SIDED|95.0|0.59|1.17|||negative binomial regression model|||||1.17|0.59|
71791362|NCT03814746|143081224|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.92|1.97|||Cox Model|for time to first occurrence of VOC||||1.97|0.92|
71791363|NCT03814746|143081224|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.58|||Cox Model|for time to first occurrence of VOC||||1.58|0.72|
71791364|NCT03814746|143081224|SUPERIORITY|for time to second occurrence of VOC|Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.81|2.04|||Cox Model|||||2.04|0.81|
71791365|NCT03814746|143081224|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.59|1.54|||Cox Model|for time to second occurrence of VOC||||1.54|0.59|
71791366|NCT03814746|143081225|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.75|1.43|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.43|0.75|
71791367|NCT03814746|143081225|SUPERIORITY||Rate ratio|0.82|||||TWO_SIDED|95.0|0.59|1.14|||Negative binomial regression model|for the Annualized rate of all visits to clinics, emergency rooms and hospitalizations||||1.14|0.59|
71791368|NCT03814746|143081225|SUPERIORITY||Rate ratio|1.11|||||TWO_SIDED|95.0|0.77|1.59|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.59|0.77|
71791369|NCT03814746|143081225|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.6|1.25|||Negative binomial regression model|for the Annualized rate of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.25|0.60|
71791370|NCT03814746|143081226|SUPERIORITY||Rate ratio|1.34|||||TWO_SIDED|95.0|0.85|2.09|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||2.09|0.85|
71791371|NCT03814746|143081226|SUPERIORITY||Rate ratio|0.88|||||TWO_SIDED|95.0|0.57|1.38|||Negative binomial regression model|for the Annualized days of all visits to clinics, emergency rooms and hospitalizations||||1.38|0.57|
71791372|NCT03814746|143081226|SUPERIORITY||Rate ratio|1.27|||||TWO_SIDED|95.0|0.77|2.09|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||2.09|0.77|
71791373|NCT03814746|143081226|SUPERIORITY||Rate ratio|0.87|||||TWO_SIDED|95.0|0.52|1.44|||Negative binomial regression model|for the Annualized days of VOC-related visits to clinics, emergency rooms and hospitalizations||||1.44|0.52|
71791374|NCT02278263|143081247|SUPERIORITY||||||<|0.05|||||||ANOVA|||Assuming a common standard deviation of 412 mL, to detect a difference of 300 mL of blood loss between the two treatment arms (sTXA and tTXA) and the placebo group, a sample size of 125 participants is required for a statistical power of 0.85, and a type I error of 0.05. The sample size required was 125 participants in total. The was increased by 15% to allow for expected dropouts. Therefore, a minimum of 147 patients was required for the study.||||<0.05
71791375|NCT03997383|143081254|SUPERIORITY||Median Difference (Net)|14.693||||0.0162|TWO_SIDED|95.0|0.693|28.692||P-value was determined by the Wilcoxon Rank Sum test,stratified by baseline tafamidis use.Analysis was performed on the 100 multiply-imputed datasets.|Wilcoxon Rank Sum Test||Median difference estimated by the Hodges-Lehmann method, stratified by baseline tafamidis use. Analysis was performed on the 100 multiply-imputed datasets.|||28.692|0.693|0.0162
71791376|NCT03997383|143081255|SUPERIORITY||Least squares (LS) mean difference|3.709|STANDARD_ERROR_OF_MEAN|1.796||0.0397|TWO_SIDED|95.0|0.176|7.242||P-value was analyzed using mixed model repeated measures (MMRM) as described in the Statistical analysis plan.|MMRM|||||7.242|0.176|0.0397
71791377|NCT03997383|143081256|SUPERIORITY||Stratified Win Ratio|1.27||||0.0574|TWO_SIDED|95.0|0.99|1.61|||Z-test|P-value was analyzed by a z-test using the mean and variance of the log-transformed win ratio estimate.||||1.61|0.99|0.0574
71791378|NCT03997383|143081257|SUPERIORITY||Hazard Ratio (HR)|0.997||||0.9888|TWO_SIDED|95.0|0.62|1.602|||Andersen-Gill||HR was derived using an Andersen-Gill model, including the treatment arm, type of ATTR amyloidosis, baseline New York Heart Association (NYHA) class, and age as covariates.|||1.602|0.620|0.9888
71791379|NCT03997383|143081258|SUPERIORITY||Hazard Ratio (HR)|0.883||||0.5609|TWO_SIDED|95.0|0.582|1.341|||Modified Andersen-Gill|P-value was derived using the modified Andersen-Gill model stratified by baseline tafamidis use.|HR was derived using the modified Andersen-Gill model stratified by baseline tafamidis use, including treatment arm, type of ATTR amyloidosis, baseline NYHA class, and age as covariates.|||1.341|0.582|0.5609
71791380|NCT06273124|143081335|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|94.0|97.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||97|94|<0.001
71791381|NCT06273124|143081336|SUPERIORITY||Kaplan-Meier 7 Day Survival Estimate|95.0|||<|0.001|TWO_SIDED|95.0|93.0|96.0|||Bootstrapping Kaplan-Meier estimates|||Ninety-five percent confidence intervals for the 7-day survival rates and p-values for the survival probabilities being greater than 75% were calculated with a bootstrap to account for the correlated data from having each participant wear multiple infusion sets.||96|93|<0.001
71791382|NCT04103892|143081338|SUPERIORITY||Least square (LS) mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.69||0.46|TWO_SIDED|95.0|-4.6|2.09|||Mixed Models Repeated Measures (MMRM|||||2.09|-4.60|0.46
71791383|NCT04103892|143081339|SUPERIORITY||Least square (LS) mean difference|-5.28|STANDARD_ERROR_OF_MEAN|2.34||0.03|TWO_SIDED|95.0|-9.91|-0.65|||Mixed Models Repeated Measures (MMRM)|||||-0.65|-9.91|0.03
71791384|NCT03341533|143081367|EQUIVALENCE|The null hypothesis is that there is no difference in NPIS between the two groups.|difference in medians|0.0||||0.39|TWO_SIDED||||||Kruskal-Wallis|||||||0.39
71791385|NCT03341533|143081368|EQUIVALENCE|The null hypothesis is that there is no difference in MME use on the hospital floor between groups.|Difference of medians|-4.5||||0.88|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual care|||||0.88
71791386|NCT03341533|143081369|EQUIVALENCE|The null hypothesis is that the outpatient MME consumption will be the same across the two groups.|difference in medians|-7.5||||0.75|TWO_SIDED||||||Kruskal-Wallis||Ice packs - Usual Care|||||0.75
71791387|NCT03341533|143081370|EQUIVALENCE|The null hypothesis is that the postoperative BPI pain severity score will be the same between groups|difference in medians|-0.3||||0.8|TWO_SIDED||||||Kruskal-Wallis||Ice Packs - Usual Care|||||0.80
71672220|NCT01575834|142862702|SUPERIORITY||LS Mean Difference|12.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|12.4|12.9|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||12.9|12.4|< 0.001
71791388|NCT00399360|143081439|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
71791389|NCT00399360|143081440|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
71791390|NCT00399360|143081441|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
71791391|NCT00399360|143081442|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|||||||0.13
71791392|NCT00399360|143081443|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
71791393|NCT00399360|143081444|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
71791394|NCT00399360|143081445|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||ANOVA|||||||0.10
71791395|NCT00399360|143081446|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|||||||0.63
71791396|NCT00399360|143081447|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71791397|NCT00399360|143081448|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
71791398|NCT01412021|143081449|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791399|NCT01412021|143081450|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791400|NCT01412021|143081451|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791401|NCT01412021|143081452|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791402|NCT01412021|143081453|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791403|NCT01412021|143081455|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791404|NCT01412021|143081457|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791405|NCT01412021|143081458|SUPERIORITY||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration||||||< 0.0001
71791406|NCT01412021|143081459|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791407|NCT01412021|143081460|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791408|NCT01412021|143081461|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791409|NCT01412021|143081462|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791410|NCT01412021|143081463|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791411|NCT01412021|143081464|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791412|NCT01412021|143081465|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791413|NCT01412021|143081466|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791414|NCT01412021|143081467|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791415|NCT01412021|143081469|SUPERIORITY|||||||0.0132|||||||paired t-test|||||||0.0132
71791416|NCT01412021|143081470|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791417|NCT01412021|143081471|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791418|NCT01412021|143081472|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791419|NCT01412021|143081473|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791420|NCT01412021|143081474|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791421|NCT01412021|143081475|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791422|NCT01412021|143081476|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71838477|NCT01369355|143184775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.140
71838478|NCT01369355|143184775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.||||||0.102
71838479|NCT05364671|143184786|SUPERIORITY|||||||0.0088||||||A priori threshold for statistical significance is set to 0.04|Chi-squared|||||||0.0088
71791423|NCT01412021|143081477|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791424|NCT01412021|143081478|SUPERIORITY||||||<|0.0001|||||||paired t-test|||||||< 0.0001
71791425|NCT03658538|143081503|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.025|TWO_SIDED|95.0|-8.2|-0.5||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||-0.5|-8.2|0.025
71791426|NCT03658538|143081504|SUPERIORITY|||||||0.061||||||P-value corresponds to the statistical significance of the group difference (active vs. control) in the primary outcome, and was not adjusted for the multiple comparison and based on the a priori threshold for statistical significance (P\<0.05).|Generalized Linear Mixed Model (GLMM)|The analysis was adjusted for covariates.||||||0.061
71791427|NCT01277523|143081602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.055||0.0457|TWO_SIDED|95.0|0.002|0.22||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.220|0.002|0.0457
71791428|NCT01277523|143081602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.055||0.1039|TWO_SIDED|95.0|-0.019|0.198||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.198|-0.019|0.1039
71791429|NCT01277523|143081603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.059||0.0509|TWO_SIDED|95.0|0.0|0.231||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.231|-0.000|0.0509
71791430|NCT01277523|143081603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.058||0.3605|TWO_SIDED|95.0|-0.061|0.168||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.168|-0.061|0.3605
71791431|NCT01277523|143081604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.059||0.1264|TWO_SIDED|95.0|-0.026|0.207|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.207|-0.026|0.1264
71791432|NCT01277523|143081604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.059||0.2845|TWO_SIDED|95.0|-0.053|0.179|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.179|-0.053|0.2845
71791433|NCT01277523|143081605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.053||0.0338|TWO_SIDED|95.0|0.009|0.217|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.217|0.009|0.0338
71791434|NCT01277523|143081605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.053||0.0999|TWO_SIDED|95.0|-0.017|0.191|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.191|-0.017|0.0999
71791435|NCT01277523|143081606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.057||0.1252|TWO_SIDED|95.0|-0.024|0.198|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.198|-0.024|0.1252
71791436|NCT01277523|143081606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.056||0.3549|TWO_SIDED|95.0|-0.058|0.163|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.163|-0.058|0.3549
71791437|NCT01277523|143081607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.088||0.1819|TWO_SIDED|95.0|-0.055|0.292|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.292|-0.055|0.1819
71791438|NCT01277523|143081607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.088||0.5448|TWO_SIDED|95.0|-0.119|0.226|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.226|-0.119|0.5448
71791439|NCT01277523|143081609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.082||0.4762|TWO_SIDED|95.0|-0.102|0.219|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo|||0.219|-0.102|0.4762
71791440|NCT01277523|143081609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.081||0.6558|TWO_SIDED|95.0|-0.123|0.196|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo|||0.196|-0.123|0.6558
71791441|NCT01277523|143081611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.153||0.996|TWO_SIDED|95.0|-0.301|0.3|||Mixed Models Analysis|||||0.300|-0.301|0.9960
71791442|NCT01277523|143081611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.151||0.703|TWO_SIDED|95.0|-0.355|0.239|||Mixed Models Analysis|||||0.239|-0.355|0.7030
71791443|NCT01277523|143081612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.094||0.7309|TWO_SIDED|95.0|-0.217|0.153|||Mixed Models Analysis|||||0.153|-0.217|0.7309
71791444|NCT01277523|143081612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.093||0.5954|TWO_SIDED|95.0|-0.232|0.133|||Mixed Models Analysis|||||0.133|-0.232|0.5954
71791445|NCT01277523|143081613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.083||0.2841|TWO_SIDED|95.0|-0.074|0.252|||Mixed Models Analysis|||||0.252|-0.074|0.2841
71791446|NCT01277523|143081613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.082||0.795|TWO_SIDED|95.0|-0.14|0.182|||Mixed Models Analysis|||||0.182|-0.140|0.7950
71791447|NCT01277523|143081614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.9671|TWO_SIDED|95.0|0.07|16.95|||Regression, Cox|||||16.95|0.07|0.9671
71838480|NCT05364671|143184787|SUPERIORITY|||||||0.0025||||||A priori threshold for statistical significance is set to 0.005|Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.0025
71791448|NCT01277523|143081614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.5557|TWO_SIDED|95.0|0.19|22.7|||Regression, Cox|||||22.70|0.19|0.5557
71791449|NCT01277523|143081615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.3567|TWO_SIDED|95.0|0.41|1.38|||Regression, Cox|||||1.38|0.41|0.3567
71791450|NCT01277523|143081615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.1168|TWO_SIDED|95.0|0.32|1.14|||Regression, Cox|||||1.14|0.32|0.1168
71791451|NCT02389998|143081654|SUPERIORITY||||||<|0.03|||||||ANCOVA|||||||<0.03
71791452|NCT02389998|143081655|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||.001
71791453|NCT02389998|143081656|SUPERIORITY|||||||0.3|||||||McNemar|||||||0.3
71791454|NCT04259762|143081657|OTHER|This is a summary of the total number of participants in the focus groups who endorsed the particular theme.|Proportion endorsing themes|1.0|||||TWO_SIDED|||||||||All focus groups were summarized together and, therefore, the denominators (N=85 \[Community\], N=11 \[Provider\]) for each theme are the same. Further, the focus groups only made qualitative (and no quantitative) assessments/endoresement of themes. No formal comparisons among groups were made.||||
71791455|NCT04259762|143081659|OTHER|Formal statistical comparisons were not made.|Proportion endorsing attempt to screen|0.567|||||TWO_SIDED|95.0|0.303|0.831|||||"Pooled estimate of attempt to screening. Using R:~n1 \<- c(20,28,11,15,26,23,21); nt \<- c(45,50,45,50,50,50,22) p1 \<- n1/nt; v1 \<- p1\*(1-p1)/nt fit \<- lm(p1 \~ 1,weight=1/v1) summary(fit)$coef\[1\] + qt(.975,6)\*c(0,-1,1)\*summary(fit)$coef\[2\]"|||0.831|0.303|
71791456|NCT01203046|143081660|NON_INFERIORITY_OR_EQUIVALENCE|It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.|Odds Ratio (OR)|2.65|||<|0.05|TWO_SIDED|95.0|0.35|19.83|||Regression, Logistic|||||19.83|0.35|<0.05
71791457|NCT01203046|143081661|NON_INFERIORITY_OR_EQUIVALENCE|Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.|Odds Ratio (OR)|1.18|||<|0.05|TWO_SIDED|95.0|0.21|6.51|||Regression, Logistic|||||6.51|0.21|<0.05
71838481|NCT05364671|143184789|SUPERIORITY|||||||0.2607|||||||Wilcoxon (Mann-Whitney)|||Mean differences (Raphamin vs. Placebo) were compared||||0.2607
71791458|NCT00706979|143081698|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.008|TWO_SIDED|95.0|1.1|1.4|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.||1.4|1.1|0.008
71791459|NCT00706979|143081699|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.09|TWO_SIDED|95.0|1.0|1.7|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.||1.7|1.0|0.09
71838482|NCT05364671|143184790|SUPERIORITY|||||||0.7601|||||||Fisher Exact|||"This analysis applies to Day 6 row."||||0.7601
71838483|NCT05364671|143184790|SUPERIORITY|||||||0.7685|||||||Fisher Exact|||"This analysis applies to Day 10 row."||||0.7685
71838484|NCT05364671|143184791|SUPERIORITY|||||||0.052|||||||Fisher Exact|||||||0.052
71838485|NCT05364671|143184792|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
71838486|NCT05364671|143184793|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||0.54
71791460|NCT00706979|143081700|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.004|TWO_SIDED|95.0|1.1|1.5|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.||1.5|1.1|0.004
71791461|NCT00706979|143081701|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.6|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.||1.6|0.9|0.3
71791462|NCT01996826|143081702|OTHER|Based on prior studies endothelial rejection episodes tend to occur in the range of about 60% of transplants. We used rates ranging from 50 to 70 % to compute the sample size. We specified the probability of a type 1 error equal to 0.05, study power equal to 80%, a follow-up period of 12 months, and 4% loss to follow-up. Calculations resulted in sample size estimates of between 65 and 124 participants.|Hazard Ratio (HR)|0.35||||0.1|TWO_SIDED|95.0|0.12|1.14|||Log Rank|||Endothelial rejection rates in patients in the treatment group and the control group were calculated using the Kaplan-Meier survival curve. The Kaplan-Meier/product limit estimator is a non-parametric statistical test used to show the probability of an event occurring at a given time interval. The Kaplan-Meier estimator is used to show what the probability of corneal transplant rejection (and therefore transplant survival) after administration of the active treatment or control.||1.14|0.12|0.10
71791463|NCT01996826|143081703|OTHER|The count of ocular adverse events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.|Risk Ratio (RR)|0.92||||0.36|TWO_SIDED|95.0|0.78|1.06|||Fisher Exact|||The incidence of Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.06|0.78|0.36
71838487|NCT05364671|143184794|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.10
71838488|NCT05364671|143184795|SUPERIORITY|||||||0.92||||||"The p-value associated with treatment\*visit interaction of pulse rate (heart rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.92
71838489|NCT05364671|143184796|SUPERIORITY|||||||0.44||||||"The p-value associated with treatment\*visit interaction of respiration rate (breathing rate) from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.44
71838490|NCT05364671|143184797|SUPERIORITY|||||||0.9||||||"The p-value associated with treatment\*visit interaction of SpO2 from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.90
71838491|NCT05364671|143184798|SUPERIORITY|||||||0.3||||||"The p-value associated with treatment\*visit interaction of SBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.30
71838492|NCT05364671|143184798|SUPERIORITY|||||||0.94||||||"The p-value associated with treatment\*visit interaction of DBP from Visit 1 to 4 between Raphamin and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.94
71791464|NCT01996826|143081703|OTHER|Mild ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95||||0.82|TWO_SIDED|95.0|0.63|1.4|||Fisher Exact|||The number of mild severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||1.4|0.63|0.82
71791465|NCT01996826|143081703|OTHER|Moderate severity ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.95|||>|0.99|TWO_SIDED|95.0|0.41|2.2|||Fisher Exact|||The number of moderate severity Ocular Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||2.2|0.41|>0.99
71791466|NCT01996826|143081703|OTHER|Severe ocular adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|0.63||||0.51|TWO_SIDED|95.0|0.2|1.9|||Fisher Exact|||Severe ocular adverse events for subjects in intervention group and control group were counted and compared.||1.9|0.20|0.51
71791467|NCT01996826|143081704|OTHER|The incidence of Systematic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were calculated and compared.|Risk Ratio (RR)|0.92||||0.24|TWO_SIDED|95.0|0.79|1.02|||Fisher Exact|||||1.02|0.79|0.24
71791468|NCT01996826|143081704|OTHER|Mild severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.62||||0.4|TWO_SIDED|95.0|0.68|3.9|||Fisher Exact|||The number of mild systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||3.9|0.68|0.40
71791469|NCT01996826|143081704|OTHER|Moderate severity systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.95|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of moderate severity systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
71791470|NCT01996826|143081704|OTHER|Severe systemic adverse events for subjects in intervention group and control group were counted and compared.|Risk Ratio (RR)|1.9|||>|0.99|TWO_SIDED|95.0|0.26|14.5|||Fisher Exact|||The number of severe systemic Adverse Events for subjects in intervention group (Avastin® (bevacizumab) and control group (0.9% NaCl \& Refresh Liquigel) were counted and compared.||14.5|0.26|>0.99
71791471|NCT04327388|143081796|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9561|TWO_SIDED|95.0|0.751|1.402|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.402|0.751|0.9561
71791472|NCT04327388|143081796|SUPERIORITY||Hazard Ratio (HR)|1.135||||0.3376|TWO_SIDED|95.0|0.835|1.543|||Log-rank test|Analyzed based on logrank test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|Hazard ratio for estimation of treatment effect of each sarilumab dose versus placebo was assessed by cox proportional hazard model stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.|||1.543|0.835|0.3376
71791473|NCT04327388|143081797|SUPERIORITY||Difference in percentage|-1.7||||0.628|TWO_SIDED|95.0|-9.27|5.81|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||5.81|-9.27|0.6280
71791474|NCT04327388|143081797|SUPERIORITY||Difference in percentage|0.2||||0.8478|TWO_SIDED|95.0|-6.93|7.41|||Cochran-Mantel-Haenszel|By Cochran-Mantel-Haenszel test stratified by severity of illness (severe, critical) and use of systemic corticosteroids (Yes, No) as entered in IRT.||||7.41|-6.93|0.8478
71791475|NCT00529542|143081876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.58|TWO_SIDED|95.0|-9.3|5.3||All hypotheses tests were two-sided.|Linear mixed-effects models|Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.|This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.|This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.||5.3|-9.3|0.58
71791476|NCT00529542|143081877|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.39|TWO_SIDED|95.0|-0.9|2.3|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2.3|-0.9|0.39
71791477|NCT00529542|143081878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.8|||<|0.001|TWO_SIDED|95.0|-95.2|-46.4|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-46.4|-95.2|<0.001
71791478|NCT00529542|143081879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.6|||<|0.001|TWO_SIDED|95.0|-79.3|-35.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-35.9|-79.3|<0.001
71791479|NCT00529542|143081880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4||||0.26|TWO_SIDED|95.0|-2.7|9.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||9.5|-2.7|0.26
71672221|NCT01575834|142862703|SUPERIORITY||LS Mean Difference|11.1|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|10.8|11.4|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||11.4|10.8|< 0.001
71791480|NCT00529542|143081881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-82.2|||<|0.001|TWO_SIDED|95.0|-126.2|-38.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-38.1|-126.2|<0.001
71791481|NCT00529542|143081882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.45|TWO_SIDED|95.0|-12.4|5.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.8|-12.4|0.45
71791482|NCT00529542|143081883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.33|TWO_SIDED|95.0|-2.8|7.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7.9|-2.8|0.33
71791483|NCT00529542|143081884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|586.0||||0.61|TWO_SIDED|95.0|-1811.0|2983.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||2983|-1811|0.61
71791484|NCT00529542|143081885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3385.0||||0.07|TWO_SIDED|95.0|-287.0|7056.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||7056|-287|0.07
71791485|NCT00529542|143081886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.88|TWO_SIDED|95.0|-24.1|27.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||27.8|-24.1|0.88
71791486|NCT00529542|143081887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.6|-0.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-0.5|-1.6|<0.001
71838493|NCT02359890|143184800|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with events|2.6|||||TWO_SIDED|95.0|0.7|6.5|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval.|||6.5|0.7|
71838494|NCT02359890|143184802|SUPERIORITY_OR_OTHER_LEGACY||Percentage of patient with acute success|96.2|||||TWO_SIDED|95.0|92.0|98.6|||||The 2-sided 95% confidence interval is derived using the exact Clopper-Pearson interval|||98.6|92.0|
71838495|NCT03536754|143184815|SUPERIORITY||LSM Ratio|1.23|STANDARD_ERROR_OF_MEAN|1.171||0.1924|TWO_SIDED|90.0|0.95|1.6||≤ 0.1924|Mixed effects model for repeated measure|||||1.6|0.95|0.1924
71838496|NCT03536754|143184815|SUPERIORITY||LSM Ratio|1.35|STANDARD_ERROR_OF_MEAN|1.172||0.0612|TWO_SIDED|90.0|1.04|1.76||≤ 0.0612|Mixed effects model for repeated measure|||||1.76|1.04|0.0612
71838497|NCT03536754|143184815|SUPERIORITY||LSM Ratio|1.05|STANDARD_ERROR_OF_MEAN|1.169||0.7653|TWO_SIDED|90.0|0.81|1.36||≤ 0.7653|Mixed effects model for repeated measure|||||1.36|0.81|0.7653
71838498|NCT03536754|143184815|SUPERIORITY||LSM Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.136||0.1537|TWO_SIDED|90.0|0.97|1.48||≤ 0.1537|Mixed effects model for repeated measure|||||1.48|0.97|0.1537
71838499|NCT03097549|143184881|SUPERIORITY||Estimated difference|-3.1||||0.001|TWO_SIDED|95.0|-4.8|-1.3|||Mixed Models Analysis|||Comparison of mean scores using a linear mixed model, incorporating baseline data and accounting for all available data. Sample size calculation: We anticipated ICIQ-UI SF improvements of 2.5 points in the treatment group and 0.9 points in the information group. Detecting this difference with 80% power, a two-sided test, and a significance level of P\<.05 would require a sample size of 49 in each group. With an expected drop-out rate of 20%, we needed approximately 60 participants in each group.||-1.3|-4.8|0.001
71838500|NCT03097549|143184882|SUPERIORITY||Estimated difference|-6.3||||0.004|TWO_SIDED|95.0|-10.5|-2.1|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-2.1|-10.5|0.004
71892567|NCT00996840|143306549|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.579|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|95.0|0.281|1.192||||||Comparison at 96 h post first dose||1.192|0.281|
71892568|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.484|STANDARD_ERROR_OF_MEAN|0.219|||TWO_SIDED|95.0|0.312|0.75||||||Comparison at 6 h post first dose||0.750|0.312|
71791487|NCT00529542|143081888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-364.3||||0.02|TWO_SIDED|95.0|-655.3|-73.2|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||-73.2|-655.3|0.02
71791488|NCT00529542|143081889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.21|TWO_SIDED|95.0|-6.4|1.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.5|-6.4|0.21
71791489|NCT00529542|143081890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9||||0.27|TWO_SIDED|95.0|-16.9|5.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||5.0|-16.9|0.27
71838501|NCT03097549|143184883|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: There is no difference in the number of urinary leakage episodes between the treatment app users and the information app users at follow-up.~ITT analysis. Missing data: 5 participants in the treatment group and 2 participants in the information group had a missing value at follow-up, and for those, the difference was set to 0 (ie, no change)."||||<0.001
71838502|NCT03097549|143184884|SUPERIORITY||Estimated difference|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-0.9|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.9|-2.8|<0.001
71892569|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.399|1.229||||||Comparison at 12 h post first dose||1.229|0.399|
71892570|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.681|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|0.37|1.254||||||Comparison at 18 h post first dose||1.254|0.370|
71892571|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.673|STANDARD_ERROR_OF_MEAN|0.302|||TWO_SIDED|95.0|0.368|1.231||||||Comparison at 24 h post first dose||1.231|0.368|
71791490|NCT00529542|143081891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.8||||0.05|TWO_SIDED|95.0|-15.8|0.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||0.1|-15.8|0.05
71791491|NCT00529542|143081892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.5||||0.48|TWO_SIDED|95.0|-6.8|13.7|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||13.7|-6.8|0.48
71791492|NCT00529542|143081893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.63|TWO_SIDED|95.0|-0.6|1.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."||1.0|-0.6|0.63
71791493|NCT03479307|143081915|SUPERIORITY||Mean Difference (Final Values)|-0.71|||<|0.0001|TWO_SIDED|95.0|-1.013|-0.407|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 4b (including all time points).||-0.407|-1.013|< 0.0001
71791494|NCT03479307|143081915|SUPERIORITY||Mean Difference (Final Values)|-1.167|||<|0.0001|TWO_SIDED|95.0|-1.439|-0.895|||ANCOVA|||Treatment Difference (95% CI): Bilastine Ophthalmic Solution 0.6% arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.895|-1.439|< 0.0001
71791495|NCT03479307|143081915|SUPERIORITY||Mean Difference (Final Values)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.413|-0.868|||ANCOVA|||Treatment Difference (95% CI): Ketotifen Ophthalmic Solution 0.025% (Zaditen) arm minus Vehicle of Bilastine Ophthalmic Solution arm at Visit 5 (including all time points).||-0.868|-1.413|< 0.0001
71791496|NCT03479307|143081915|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|0.009||||0.0007|ONE_SIDED|97.5||0.235|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 3 minutes Post-CAC (non-inferiority test).||0.235||0.0007
71791497|NCT03479307|143081915|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.077||||0.0002|ONE_SIDED|97.5||0.175|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 5 minutes Post-CAC (non-inferiority test).||0.175||0.0002
71791498|NCT03479307|143081915|NON_INFERIORITY|Non-inferiority margin of 0.40|Mean Difference (Final Values)|-0.159|||<|0.0001|ONE_SIDED|97.5||0.101|||ANCOVA|||Treatment Difference (one-sided, 97.5% CI): Bilastine Ophthalmic Solution 0.6% arm minus Ketotiphen Ophthalmic Solution 0.025% (Zaditen) arm at Visit 5, 7 minutes Post-CAC (non-inferiority test).||0.101||< 0.0001
71791499|NCT05778786|143081948|SUPERIORITY|A superiority margin of 0.0 logMAR was used.|Least-Square Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.012|||ONE_SIDED|95.0||-0.1|||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 9 subjects provide at least 99% statistical power to test for superiority.||-0.10||
71791500|NCT05778786|143081949|SUPERIORITY|A superiority margin of 62 points was used.|Least-quares mean|69.4|STANDARD_ERROR_OF_MEAN|2.13|||ONE_SIDED|95.0|65.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 165 subjects provide at least 99% statistical power to test for superiority.|||65.2|
71791501|NCT05778786|143081950|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.974|STANDARD_DEVIATION|0.01|||TWO_SIDED|95.0|0.95|0.989|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.989|0.950|
71791502|NCT05778786|143081951|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|0.976|0.997|||Bayesian beta-binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.976|
71791503|NCT05778786|143081952|SUPERIORITY|A superiority margin of 0.80 was used|Mean Central Posterior Proportion|0.989|STANDARD_DEVIATION|0.0053|||TWO_SIDED|95.0|0.977|0.997|||Bayesian beta- binomial model|Method used is Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.99 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible interval.||0.997|0.977|
71838503|NCT03097549|143184885|SUPERIORITY||Estimated difference|-1.6||||0.016|TWO_SIDED|95.0|-2.8|-0.3|||Mixed Models Analysis|||Null hypothesis: There is no difference in score between the treatment group and the information group at follow-up.||-0.3|-2.8|0.016
71838504|NCT03097549|143184886|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: no difference in usage between treatment group and information group at follow-up.||||0.01
71791504|NCT05778786|143081953|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Central Posterior Proportion|0.003|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|0.0|0.01|||Bayesian beta-binomial model|Bayesian beta- binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.01 and an intraclass correlation of 0.70, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 99% with 95% central posterior credible Interval.||0.010|0.000|
71791505|NCT05778786|143081954|SUPERIORITY|A superiority margin of 58 points was used.|Least-squares Mean|66.1|STANDARD_ERROR_OF_MEAN|2.48|||ONE_SIDED|95.0|61.2||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||61.2|
71791506|NCT05778786|143081955|SUPERIORITY|A superiority margin of 61 points was used.|Least-squares Mean|69.9|STANDARD_ERROR_OF_MEAN|1.66|||ONE_SIDED|95.0|66.6||||Linear Mixed Model|||It was calculated using a 1-sided one sample mean t-test with a type I error rate of 0.025 that 135 subjects provide at least 97% statistical power to test for superiority.|||66.6|
71838505|NCT03097549|143184887|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in improvement between the treatment group and the information group att follow-up.||||<0.001
71892572|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.92|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|0.456|1.857||||||Comparison at 48 h post first dose||1.857|0.456|
71791507|NCT02446990|143081956|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.06||0.1969|TWO_SIDED|95.0|0.96|1.2|||Regression, Cox|||||1.2|0.96|0.1969
71791508|NCT02446990|143081957|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.07||0.3461|TWO_SIDED|95.0|0.94|1.21|||Regression, Cox|||||1.21|0.94|0.3461
71791509|NCT02446990|143081958|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.1|STANDARD_ERROR_OF_MEAN|0.09||0.2493|TWO_SIDED|95.0|0.94|1.28|||Regression, Cox|||||1.28|0.94|0.2493
71791510|NCT02446990|143081959|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06|STANDARD_ERROR_OF_MEAN|0.09||0.5162|TWO_SIDED|95.0|0.89|1.26|||Regression, Cox|||||1.26|0.89|0.5162
71791511|NCT02446990|143081960|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.35|STANDARD_ERROR_OF_MEAN|0.29||0.1647|TWO_SIDED|95.0|0.88|2.05|||Regression, Cox|||||2.05|0.88|0.1647
71791512|NCT02446990|143081961|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.04|STANDARD_ERROR_OF_MEAN|0.08||0.6024|TWO_SIDED|95.0|0.9|1.21|||Regression, Cox|||||1.21|0.90|0.6024
71791513|NCT02446990|143081962|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.89||||0.1458|TWO_SIDED|95.0|0.75|1.04|||Regression, Cox|||||1.04|0.75|0.1458
71791514|NCT02446990|143081963|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.979|TWO_SIDED|95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9790
71791515|NCT02446990|143081964|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.4299|TWO_SIDED|95.0|0.92|1.22|||Regression, Cox|||||1.22|0.92|0.4299
71791516|NCT02446990|143081965|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5916|TWO_SIDED|95.0|0.88|1.08|||Regression, Cox|||||1.08|0.88|0.5916
71791517|NCT02446990|143081966|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.98||||0.6963|TWO_SIDED|95.0|0.89|1.08|||Regression, Cox|||||1.08|0.89|0.6963
71791518|NCT02446990|143081967|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.06||||0.2222|TWO_SIDED|95.0|0.96|1.18|||Regression, Cox|||||1.18|0.96|0.2222
71791519|NCT02446990|143081968|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.05||||0.3671|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.3671
71838506|NCT02547233|143184889|SUPERIORITY||Ratio of clearance rates|30.55|||<|0.001|TWO_SIDED|95.0|4.28|218.0|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|||218.0|4.28|<0.001
71838507|NCT02547233|143184890|SUPERIORITY||Ratio of clearance rates|12.26|||<|0.001|TWO_SIDED|95.0|4.73|31.78|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||31.78|4.73|<0.001
71838508|NCT02547233|143184891|SUPERIORITY||Ratio of clearance rates|10.31|||<|0.001|TWO_SIDED|95.0|4.43|23.97|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||23.97|4.43|<0.001
71791520|NCT02446990|143081969|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.97||||0.5285|TWO_SIDED|95.0|0.87|1.07|||Regression, Cox|||||1.07|0.87|0.5285
71791521|NCT02921776|143081972|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.45|TWO_SIDED||||||t-test, 2 sided|||||||0.45
71791522|NCT02921776|143081973|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||0.55
71791523|NCT02921776|143081974|OTHER|||||||0.1|||||||Effect size|Effect size =-0.29||||||0.10
71791524|NCT02921776|143081974|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED||||||t-test, 2 sided|||||||.10
71791525|NCT02921776|143081975|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||Benzodiazepine exposure||||0.02
71791526|NCT02921776|143081975|SUPERIORITY|||||||0.291|||||||Mixed Models Analysis|||Opioid Exposure||||0.291
71791527|NCT02921776|143081976|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
71791528|NCT02921776|143081977|SUPERIORITY|||||||0.32|TWO_SIDED|95.0|||||Chi-squared|||||||0.32
71791529|NCT02921776|143081978|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.19|4.72|||Mixed Models Analysis|||||4.72|0.19|0.93
71791530|NCT02921776|143081979|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.07|TWO_SIDED||||||t-test, 2 sided|||||||0.07
71791531|NCT02921776|143081981|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71791532|NCT02921776|143081982|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Baseline||||0.94
71791533|NCT02921776|143081982|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Patient Extubation or Discharge from ICU||||0.89
71791534|NCT02921776|143081982|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||1-Month||||0.38
71791535|NCT02921776|143081982|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||3-Month||||0.63
71791536|NCT02921776|143081982|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||.73
71791537|NCT02921776|143081983|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Baseline||||0.82
71791538|NCT02921776|143081983|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Patient extubation or discharge from ICU||||0.84
71791539|NCT02921776|143081983|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||1-month||||0.96
71791540|NCT02921776|143081983|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||3-Month||||0.17
71791541|NCT02921776|143081983|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||.39
71791542|NCT02921776|143081984|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||1-month||||0.26
71791543|NCT02921776|143081984|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||3-month||||0.25
71791544|NCT02921776|143081984|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||6-month||||0.79
71892573|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.944|STANDARD_ERROR_OF_MEAN|0.376|||TWO_SIDED|95.0|0.445|2.002||||||Comparison at 72 h post first dose||2.002|0.445|
71791545|NCT02921776|143081992|SUPERIORITY||Odds Ratio (OR)|0.23||||0.05|TWO_SIDED|95.0|0.05|1.01|||t-test, 2 sided|||||1.01|0.05|0.05
71791546|NCT02921776|143081992|SUPERIORITY||Odds Ratio (OR)|0.27||||0.1|TWO_SIDED|95.0|0.06|1.3|||Regression, Linear|||Adjusted for baseline communication difficulty||1.30|0.06|0.10
71791547|NCT05478252|143082018|NON_INFERIORITY|Non-inferiority of insulin semaglutide J versus insulin semaglutide B was considered as confirmed if the 95% confidence interval (CI) for the mean treatment difference lied entirely below 2.5%. Non-inferiority was investigated on the FAS.|Treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.3|0.08|||ANCOVA|||||0.08|-0.30|<.0001
71791548|NCT03939897|143082028|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.506|||||||Log Rank|||||||0.5060
71791549|NCT03939897|143082031|OTHER|This test is used to compare the survival distributions of different groups in a survival analysis. It's a nonparametric test.||||||0.2989|||||||Log Rank|||||||0.2989
71791550|NCT03928847|143082032|SUPERIORITY|The mean EGCG blood levels were compared among 450 mg, 600 mg, and 750 mg groups.|Mean Difference (Net)|250.0|||||TWO_SIDED|||||||||||||
71791551|NCT03928847|143082033|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71791552|NCT03928847|143082034|OTHER|ELISA data from each patient before and after EGCG treatment were compared and analyzed with the use of the Wilcoxon signed-rank test (two-tailed).|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71892574|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.905|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|95.0|0.476|1.723||||||Comparison at 96 h post first dose||1.723|0.476|
71791553|NCT03928847|143082035|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
71791554|NCT03928847|143082036|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
71791555|NCT03928847|143082037|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
71672222|NCT01575834|142862704|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.6|6.0|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||6.0|5.6|< 0.001
71791556|NCT01881230|143082038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.692||||0.0183|TWO_SIDED|95.0|1.089|2.629|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||2.629|1.089|0.0183
71791557|NCT01881230|143082038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.581||||0.0152|TWO_SIDED|95.0|0.373|0.904|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||0.904|0.373|0.0152
71791558|NCT01881230|143082038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.039||||0.8599|TWO_SIDED|95.0|0.676|1.597|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (\<= 1 year; \> 1 year).||1.597|0.676|0.8599
71791559|NCT01881230|143082041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.375||||0.1579|TWO_SIDED|95.0|0.882|2.143|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||2.143|0.882|0.1579
71791560|NCT01881230|143082041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.2945|TWO_SIDED|95.0|0.52|1.221|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.221|0.520|0.2945
71791561|NCT01881230|143082041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101||||0.6691|TWO_SIDED|95.0|0.71|1.708|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; \> 1 year).||1.708|0.710|0.6691
71791562|NCT00518323|143082046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|3.17||0.508||95.0|-8.36|4.16||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||4.16|-8.36|0.508
71892575|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.726|STANDARD_ERROR_OF_MEAN|0.199|||TWO_SIDED|95.0|0.488|1.08||||||Comparison at 6 h post first dose||1.080|0.488|
71892576|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.791|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.476|1.317||||||Comparison at 12 h post first dose||1.317|0.476|
71892577|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.725|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|0.417|1.26||||||Comparison at 18 h post first dose||1.260|0.417|
71892578|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.655|STANDARD_ERROR_OF_MEAN|0.273|||TWO_SIDED|95.0|0.379|1.13||||||Comparison at 24 h post first dose||1.130|0.379|
71892579|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.111|STANDARD_ERROR_OF_MEAN|0.323|||TWO_SIDED|95.0|0.583|2.12||||||Comparison at 48 h post first dose||2.120|0.583|
71672223|NCT01575834|142862705|SUPERIORITY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|5.1|5.5|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.5|5.1|< 0.001
71672224|NCT01575834|142862706|SUPERIORITY||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.9|5.4|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.4|4.9|< 0.001
71672225|NCT01575834|142862707|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|4.7|5.2|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.||5.2|4.7|< 0.001
71672226|NCT01514292|142862736|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Fisher Exact|||"Hence, the hypothesis is established as:~Ho: pi \< 71.5% Ha: pi \>71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded."||||0.0001
71672227|NCT02220764|142862738|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.||||0.03
71672228|NCT05000164|142862740|SUPERIORITY||Least-square Mean|-0.12|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.17|-0.07|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.0 logMAR for distance.|Distance (4m)||-0.07|-0.17|
71672229|NCT05000164|142862740|SUPERIORITY||Least-square Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|-0.06|0.04|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for intermediate.|Intermediate (64cm)||0.04|-0.06|
71672230|NCT05000164|142862740|SUPERIORITY||Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.04|0.15|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|The upper limit of each 95% confidence interval was compared to 0.17 logMAR for near.|Near (40cm)||0.15|0.04|
71672231|NCT06509438|142862759|OTHER|Compare 4 weeks after the last injection to baseline|Difference of medians|-0.45|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71672232|NCT06509438|142862759|OTHER|Compare 12 weeks after the last injection to baseline|Difference of medians|-0.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71791563|NCT00518323|143082046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|STANDARD_ERROR_OF_MEAN|3.27||0.006||95.0|-16.58|-3.67||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-3.67|-16.58|0.006
71791564|NCT00518323|143082046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|3.29||0.086||95.0|-13.07|-0.09||The p value was associated with the closed testing procedure using Dunnett's test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.||-0.09|-13.07|0.086
71672233|NCT03331796|142862763|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|3.1||0.63|TWO_SIDED|95.0|-4.8|7.9|||Regression, Linear|Adjusted for baseline||||7.9|-4.8|0.63
71672234|NCT03331796|142862763|SUPERIORITY||Mean Difference (Final Values)|6.9|STANDARD_ERROR_OF_MEAN|3.3||0.0476|TWO_SIDED|95.0|0.1|13.7|||Regression, Linear|||||13.7|0.1|0.0476
71672235|NCT03331796|142862764|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.1||0.45|TWO_SIDED|95.0|-11.4|5.2|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.2|-11.4|0.45
71672236|NCT03331796|142862764|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|4.4||0.21|TWO_SIDED|95.0|-3.3|14.8|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||14.8|-3.3|0.21
71672237|NCT03331796|142862765|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.38||0.29|TWO_SIDED|95.0|-0.36|1.19|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.19|-0.36|0.29
71672238|NCT03331796|142862765|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.4||0.51|TWO_SIDED|95.0|-0.55|1.08|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.08|-0.55|0.51
71672239|NCT03331796|142862766|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.33|TWO_SIDED|95.0|-1.0|3.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.0|-1.0|.33
71672240|NCT03331796|142862766|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.0||0.0038|TWO_SIDED|95.0|1.1|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|1.1|0.0038
71672241|NCT03331796|142862767|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.78||0.58|TWO_SIDED|95.0|-1.1|2.0|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.0|-1.1|0.58
71791565|NCT00518323|143082047|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.968
71791566|NCT00518323|143082047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||<0.001
71791567|NCT00518323|143082047|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.||||0.021
71791568|NCT00518323|143082048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0|-4.54|3.73||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.73|-4.54|0.846
71791569|NCT00518323|143082048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|2.17|<|0.001||95.0|4.28|12.82||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||12.82|4.28|<0.001
71791570|NCT00518323|143082048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|2.18||0.067||95.0|-0.28|8.33||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||8.33|-0.28|0.067
71791571|NCT00518323|143082049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|4.27||0.058||95.0|-0.29|16.56||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||16.56|-0.29|0.058
71791572|NCT00518323|143082049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.8|STANDARD_ERROR_OF_MEAN|4.4|<|0.001||95.0|8.08|25.43||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||25.43|8.08|<0.001
71791573|NCT00518323|143082049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|STANDARD_ERROR_OF_MEAN|4.43||0.003||95.0|4.76|22.23||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||22.23|4.76|0.003
71791574|NCT00518323|143082050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|4.15||0.237||95.0|-13.11|3.26||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||3.26|-13.11|0.237
71791575|NCT00518323|143082050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|4.28||0.119||95.0|-15.15|1.74||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||1.74|-15.15|0.119
71791576|NCT00518323|143082050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.34||0.574||95.0|-11.0|6.11||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.||||6.11|-11.00|0.574
71791577|NCT01514760|143082054|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANCOVA|||This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.||||0.03
71791578|NCT03329690|143082069|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH test with region as a stratification factor||||||<0.0001
71892580|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.075|STANDARD_ERROR_OF_MEAN|0.346|||TWO_SIDED|95.0|0.539|2.146||||||Comparison at 72 h post first dose||2.146|0.539|
71791579|NCT02418468|143082087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.262|TWO_SIDED|95.0|-0.26|0.07|||mixed models for repeated measures (MMRM|||||0.07|-0.26|0.262
71791580|NCT02337907|143082094|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.073||0.7907|TWO_SIDED|95.0|-0.163|0.124||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.124|-0.163|0.7907
71813326|NCT01181726|143129083|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.92|||||TWO_SIDED|90.0|93.44|102.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.61|93.44|
71892581|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.375|STANDARD_ERROR_OF_MEAN|0.313|||TWO_SIDED|95.0|0.735|2.574||||||Comparison at 96 h post first dose||2.574|0.735|
71672242|NCT03331796|142862767|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.59|TWO_SIDED|95.0|-2.2|1.3|||Regression, Linear|Adjusted for baseline||||1.3|-2.2|0.59
71672243|NCT03331796|142862768|SUPERIORITY||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|5.2||0.3|TWO_SIDED|95.0|-5.2|16.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||16.1|-5.2|0.30
71791581|NCT02337907|143082094|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7622|TWO_SIDED|95.0|-0.125|0.171||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.171|-0.125|0.7622
71791582|NCT02337907|143082094|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.071||0.8789|TWO_SIDED|95.0|-0.13|0.152||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.152|-0.130|0.8789
71791583|NCT02337907|143082094|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0609|TWO_SIDED|95.0|-0.285|0.006||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.006|-0.285|0.0609
71791584|NCT02337907|143082094|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5687|TWO_SIDED|95.0|-0.135|0.074||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.074|-0.135|0.5687
71791585|NCT02337907|143082095|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.120|-0.101|0.8694
71791586|NCT02337907|143082095|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.109|-0.116|0.9512
71791587|NCT02337907|143082095|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.115|-0.105|0.9321
71838509|NCT02547233|143184892|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.37||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.37|0.25|<0.001
71838510|NCT03524612|143184956|OTHER||||||<|0.0001|||||||Clopper Pearson test|||||||<0.0001
71672244|NCT03331796|142862768|SUPERIORITY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|4.9||0.34|TWO_SIDED|95.0|-14.9|5.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||5.3|-14.9|0.34
71672245|NCT03331796|142862769|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|10.6||0.996|TWO_SIDED|95.0|-22.0|22.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||22.1|-22.0|0.996
71672246|NCT03331796|142862769|SUPERIORITY||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|10.8||0.87|TWO_SIDED|95.0|-20.6|24.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||24.3|-20.6|0.87
71791588|NCT02337907|143082095|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.025|-0.199|0.1288
71791589|NCT02337907|143082095|SUPERIORITY|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.||0.061|-0.098|0.6492
71791590|NCT02337907|143082096|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|1.066||0.5287|TWO_SIDED|95.0|-1.43|2.77||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||2.77|-1.43|0.5287
71791591|NCT02337907|143082096|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.099||0.7105|TWO_SIDED|95.0|-2.57|1.76||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.76|-2.57|0.7105
71791592|NCT02337907|143082096|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.064||0.3822|TWO_SIDED|95.0|-1.16|3.03||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.03|-1.16|0.3822
71791593|NCT02337907|143082096|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.066||0.6472|TWO_SIDED|95.0|-2.59|1.61||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||1.61|-2.59|0.6472
71791594|NCT02337907|143082097|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7551|TWO_SIDED|95.0|-0.46|0.64||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.64|-0.46|0.7551
71791595|NCT02337907|143082097|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3643|TWO_SIDED|95.0|-0.29|0.8||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.80|-0.29|0.3643
71791596|NCT02337907|143082097|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7822|TWO_SIDED|95.0|-0.45|0.6||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.60|-0.45|0.7822
71791597|NCT02337907|143082097|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.6889|TWO_SIDED|95.0|-0.43|0.65||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward-Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.||0.65|-0.43|0.6889
71892582|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.559|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.4|0.783||||||Comparison at 6 h post first dose||0.783|0.400|
71892583|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.83|STANDARD_ERROR_OF_MEAN|0.216|||TWO_SIDED|95.0|0.539|1.277||||||Comparison at 12 h post first dose||1.277|0.539|
71791598|NCT02337907|143082098|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.933||0.1595|TWO_SIDED|95.0|-0.52|3.15||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.15|-0.52|0.1595
71791599|NCT02337907|143082098|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.962||0.2455|TWO_SIDED|95.0|-0.77|3.01||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.01|-0.77|0.2455
71791600|NCT02337907|143082098|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.28|STANDARD_ERROR_OF_MEAN|0.94||0.1732|TWO_SIDED|95.0|-0.57|3.13||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||3.13|-0.57|0.1732
71791601|NCT02337907|143082098|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|0.936||0.0088|TWO_SIDED|95.0|0.63|4.31||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.||4.31|0.63|0.0088
71791602|NCT02876900|143082099|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.634||0.003|TWO_SIDED|95.0|-8.06|-1.64||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-1.64|-8.06|0.003
71791603|NCT02876900|143082099|SUPERIORITY|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-9.81|-3.4||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-3.4|-9.81|<0.001
71791604|NCT02876900|143082100|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.16|-0.55|<0.001
71791605|NCT02876900|143082100|SUPERIORITY||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.64|-0.25||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.||-0.25|-0.64|<0.001
71791606|NCT01592344|143082101|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0048
71791607|NCT01592344|143082102|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71791608|NCT01592344|143082103|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71791609|NCT01592344|143082104|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71791610|NCT05413369|143082119|NON_INFERIORITY|The non-inferiority was assessed using the upper bound of the 2-sided 95% confidence interval (CI). Non-inferiority p-value was calculated from a non-inferiority margin of 0.3%.|Least Squares (LS) Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.33|-0.07|||ANCOVA|Treatment groups and randomization stratum of previous oral anti-diabetic drug(OADs) as fixed effects,and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.07|-0.33|<0.001
71791611|NCT05413369|143082120|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|97.5|-0.35|-0.05|||ANCOVA|Treatment groups and randomization stratum of previous as fixed effects, and baseline HbA1c continuous value as covariate||Statistical analysis for change from baseline in HbA1c||-0.05|-0.35|0.003
71672247|NCT03331796|142862770|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.06||0.97|TWO_SIDED|95.0|-2.14|2.22|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.22|-2.14|0.97
71672248|NCT03331796|142862770|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|1.11||0.91|TWO_SIDED|95.0|-2.15|2.41|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.41|-2.15|0.91
71672249|NCT03331796|142862771|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|1.0||0.84|TWO_SIDED|95.0|-2.3|1.9|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.9|-2.3|0.84
71791612|NCT05413369|143082121|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|97.5|-2.32|-0.66|||ANCOVA|Treatment groups, randomization stratums of HbA1c and previous OADs as fixed effects, and baseline body weight continuous value as covariate.||Statistical analysis for change from baseline in body weight||-0.66|-2.32|<0.001
71791613|NCT05413369|143082122|SUPERIORITY||Odds Ratio (OR)|1.89|||<|0.001|TWO_SIDED|97.5|1.25|2.85|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c||Statistical analysis for percentage of participants reaching HbA1c value \<7% at Week 24||2.85|1.25|<0.001
71791614|NCT05413369|143082123|SUPERIORITY||Odds Ratio (OR)|2.59|||<|0.001|TWO_SIDED|95.0|1.79|3.76|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24||3.76|1.79|<0.001
71791615|NCT05413369|143082124|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.52|3.6|||Regression, Logistic|Adjusted for treatment group, randomization stratum of previous OADs, and continuous baseline value of HbA1c and body weight.||Statistical analysis for percentage of participants reaching HbA1c value \<7% with no body weight gain at Week 24 and no hypoglycemia during treatment||3.60|1.52|<0.001
71791616|NCT00720057|143082138|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.||||<0.001
71791617|NCT00720057|143082139|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71791618|NCT00720057|143082140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71791619|NCT00720057|143082141|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.||||<0.001
71791620|NCT00720057|143082142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71791621|NCT00720057|143082143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
71791622|NCT01519414|143082186|OTHER|||||||0.02|||||||Log Rank|||||||0.02
71672250|NCT03331796|142862771|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|1.0||0.8|TWO_SIDED|95.0|-1.9|2.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.4|-1.9|0.80
71672251|NCT03331796|142862772|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|2.0||0.48|TWO_SIDED|95.0|-5.5|2.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.6|-5.5|0.48
71791623|NCT00391274|143082208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.1326||95.0|0.76|8.25||Logistic regression of best overall tumor response (complete response + partial response).|Regression, Logistic|Treatment was the only covariate.||||8.25|0.76|0.1326
71892584|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.987|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|95.0|0.613|1.589||||||Comparison at 18 h post first dose||1.589|0.613|
71672252|NCT03331796|142862772|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|2.0||0.18|TWO_SIDED|95.0|-6.8|1.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.3|-6.8|0.18
71672253|NCT03331796|142862773|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.075|TWO_SIDED|95.0|-5.7|0.3|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.3|-5.7|0.075
71672254|NCT03331796|142862773|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.6||0.195|TWO_SIDED|95.0|-5.4|1.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||1.1|-5.4|0.195
71672255|NCT03331796|142862774|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.1||0.28|TWO_SIDED|95.0|-1.0|3.4|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.4|-1.0|0.28
71791624|NCT00391274|143082209|SUPERIORITY_OR_OTHER|||||||0.7704||95.0|||||Log Rank|||||||0.7704
71791625|NCT00391274|143082209|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7784||95.0|0.75|1.46|||Regression, Cox|Treatment was the only covariate.||||1.46|0.75|0.7784
71791626|NCT00391274|143082212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.4921||95.0|0.78|1.68||P-value for Overall Survival (up to 24 months)|Regression, Cox|Treatment was the only covariate.||||1.68|0.78|0.4921
71791627|NCT00391274|143082212|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9256|TWO_SIDED|95.0|0.74|1.4||P-value for Overall Survival (up to 30 months)|Regression, Cox|||||1.40|0.74|0.9256
71791628|NCT03559257|143082243|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-3.92|-2.32|||Mixed Models Analysis|||||-2.32|-3.92|<0.0001
71791629|NCT03559257|143082244|SUPERIORITY||LSMean Difference|-2.57|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001|TWO_SIDED|95.0|-3.41|-1.72|||Mixed Models Analysis|||||-1.72|-3.41|<0.0001
71791630|NCT03559257|143082245|SUPERIORITY||Odds Ratio (OR)|3.935|||<|0.0001|TWO_SIDED|95.0|2.719|5.693|||pseudo likelihood-based repeated measure|||||5.693|2.719|<0.0001
71791631|NCT03559257|143082246|SUPERIORITY||Odds Ratio (OR)|3.481|||<|0.0001|TWO_SIDED|95.0|2.252|5.381|||Pseudo likelihood-based repeated measure|||||5.381|2.252|<0.0001
71892585|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.924|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|0.582|1.467||||||Comparison at 24 h post first dose||1.467|0.582|
71791632|NCT03559257|143082247|SUPERIORITY||LSMean Difference|12.53|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|9.19|15.87|||Mixed Models Analysis|||||15.87|9.19|<0.0001
71791633|NCT03559257|143082248|SUPERIORITY||LSMean Difference|11.51|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|7.14|15.89|||Mixed Models Analysis|||||15.89|7.14|<0.0001
71791634|NCT03559257|143082249|SUPERIORITY||Odds Ratio (OR)|5.878||||0.0001|TWO_SIDED|95.0|2.374|14.554|||Pseudo likelihood-based repeated measure|||||14.554|2.374|0.0001
71791635|NCT03559257|143082250|SUPERIORITY||Odds Ratio (OR)|999.999|||<|0.0001|TWO_SIDED|95.0|548.706|999.999|||Pseudo likelihood-based repeated measure||Estimated value and upper bound are \>999.999|||999.999|548.706|<0.0001
71791636|NCT03559257|143082251|SUPERIORITY||Odds Ratio (OR)|5.012|||<|0.0001|TWO_SIDED|95.0|2.352|10.679|||pseudo likelihood-based repeated measure|||||10.679|2.352|<0.0001
71791637|NCT03559257|143082252|SUPERIORITY||Odds Ratio (OR)|999.99|||<|0.0001|TWO_SIDED|95.0|999.99|999.99|||Pseudo likelihood-based repeated measure||Point estimate, upper limit and lower limit are \>999.99|||999.99|999.99|<0.0001
71791638|NCT03559257|143082253|SUPERIORITY||LSMean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-4.14|-2.65|||Mixed Models Analysis|||||-2.65|-4.14|<0.0001
71791639|NCT03559257|143082254|SUPERIORITY||LSMean Difference|-3.13|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-3.96|-2.29|||Mixed Models Analysis|||||-2.29|-3.96|<0.0001
71791640|NCT03559257|143082255|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71791641|NCT03559257|143082256|SUPERIORITY||LSMean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.58|-0.54|||Mixed Models Analysis|||||-0.54|-1.58|<0.0001
71791642|NCT03559257|143082257|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Activity Impairment.||||<0.0001
71791643|NCT03559257|143082257|SUPERIORITY|||||||0.388|||||||ANCOVA|||Absenteeism.||||0.3880
71791644|NCT03559257|143082257|SUPERIORITY|||||||0.0004|||||||ANCOVA|||Presenteeism.||||0.0004
71791645|NCT03559257|143082257|SUPERIORITY|||||||0.0003|||||||ANCOVA|||Work impairment.||||0.0003
71791646|NCT03559257|143082258|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
71791647|NCT03559257|143082259|SUPERIORITY|||||||0.1267|||||||ANCOVA|||||||0.1267
71791648|NCT03559257|143082260|SUPERIORITY|||||||0.163|||||||ANCOVA|||||||0.1630
71791649|NCT03559257|143082261|SUPERIORITY|||||||0.0277|||||||ANCOVA|||||||0.0277
71791650|NCT01387347|143082268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.2596|||||||t-test, 2 sided|||Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level||||0.2596
71791651|NCT01387347|143082268|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||t-test, 2 sided|||Comparison of central corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0075
71791652|NCT01387347|143082268|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||t-test, 2 sided|||Comparison of superior corneal fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0210
71791653|NCT01387347|143082269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.3734|TWO_SIDED||||||t-test, 2 sided|||Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.||||0.3734
71791654|NCT01387347|143082269|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED||||||t-test, 2 sided|||Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28||||0.0244
71892586|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.23|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|0.716|2.11||||||Comparison at 48 h post first dose||2.110|0.716|
71791655|NCT01519960|143082271|OTHER||Odds Ratio (OR)|5.43|||=|0.0043|TWO_SIDED|95.0|1.54|19.2|||Cochran-Mantel-Haenszel|||Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (\<) 5 times (×) upper limit of normal (ULN) versus greater than or equal to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.||19.2|1.54|= 0.0043
71791656|NCT01519960|143082271|OTHER||||||=|0.3732|||||||Breslow-Day|||||||= 0.3732
71791657|NCT00561080|143082347|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|Geometric Mean Titer Ratio (GMTR)|1.11||||0.948|TWO_SIDED|95.0|1.02|1.22|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||1.22|1.02|0.948
71791658|NCT00561080|143082347|NON_INFERIORITY_OR_EQUIVALENCE|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|GMTR|0.78|||>|0.999|TWO_SIDED|95.0|0.73|0.85|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1|||0.85|0.73|>0.999
71791659|NCT00561080|143082348|SUPERIORITY_OR_OTHER||GMFR|2.35|||||TWO_SIDED|95.0|2.11|2.62|||||GMFR=GMT Post Dose/GMT Pre Dose|||2.62|2.11|
71791660|NCT00561080|143082350|SUPERIORITY_OR_OTHER||GMT Ratio|1.06|||||TWO_SIDED|95.0|0.96|1.17|||||GMT Ratio = Group 2 GMT/Group 1 GMT|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.17|0.96|
71791661|NCT00561080|143082350|SUPERIORITY_OR_OTHER||GMT Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||GMT Ratio = GMT Group 3/GMT Group 1|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model||1.19|0.98|
71791662|NCT03706794|143082385|SUPERIORITY||Mann-Whitney U|43.0||||0.829|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.829
71791663|NCT03706794|143082386|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
71892587|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.289|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|0.719|2.312||||||Comparison at 72 h post first dose||2.312|0.719|
71791664|NCT03706794|143082387|SUPERIORITY||Mann-Whitney U|45.5||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
71791665|NCT03706794|143082388|SUPERIORITY||Mann-Whitney U|46.0||||0.633|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.633
71791666|NCT03706794|143082389|SUPERIORITY||Mann-Whitney U|52.0||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.315
71791667|NCT03526458|143082406|SUPERIORITY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|5.6||0.012|TWO_SIDED|95.0|4.4|28.9|||t-test, 2 sided|||||28.9|4.4|0.012
71791668|NCT03526458|143082407|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|7.3||0.132|TWO_SIDED|95.0|-3.6|26.3|||t-test, 2 sided|||||26.3|-3.6|0.132
71791669|NCT03526458|143082408|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.7||0.654|TWO_SIDED|95.0|-4.4|6.9|||t-test, 2 sided|||||6.9|-4.4|0.654
71791670|NCT03526458|143082409|SUPERIORITY|||||||0.299|||||||Chi-squared|||||||0.299
71791671|NCT03526458|143082410|SUPERIORITY|||||||0.076|||||||Chi-squared|||||||0.076
71791672|NCT03526458|143082411|SUPERIORITY||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|143.9||0.943|TWO_SIDED|95.0|-286.0|306.8|||t-test, 2 sided|||||306.8|-286|0.943
71791673|NCT03526458|143082412|SUPERIORITY|||||||0.185|||||||Chi-squared|||||||0.185
71791674|NCT01082965|143082423|SUPERIORITY_OR_OTHER||Leasts Square (LS) Mean|-0.01|STANDARD_ERROR_OF_MEAN|0.265||0.9742|TWO_SIDED|95.0|-0.6|0.58||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Mixed model for repeated measures (MMRM) was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, Apolipoprotein E (ApoE) genotype, site as covariates.||0.58|-0.60|0.9742
71791675|NCT01082965|143082424|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9638|TWO_SIDED|95.0|-0.51|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.51|0.9638
71791676|NCT01082965|143082425|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.153||0.2548|TWO_SIDED|95.0|-0.53|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.53|0.2548
71791677|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.057||0.6316|TWO_SIDED|95.0|-0.18|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.18|0.6316
71791678|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.063||0.6256|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.6256
71791679|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.059||0.5847|TWO_SIDED|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.12|0.5847
71791680|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.123||0.1555|TWO_SIDED|95.0|-0.46|0.09||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.09|-0.46|0.1555
71791681|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.151||0.2416|TWO_SIDED|95.0|-0.51|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.51|0.2416
71838511|NCT05457647|143184980|OTHER|The accuracy and precision of the theranostic imaging biomarkers, including both the riboflavin score and theranostic score, to predict CXL treatment outcome were determined by calculating the proportion of correctly classified eyes and the positive predictive value respectively.|Proportion|91.0|||||TWO_SIDED|95.0|||||||The study set a minimum threshold of 85 for the the combined use of the theranostic imaging biomarkers' accuracy and precision in predicting the propensity of CXL to halt disease progression at 1 year in the study population.|Accuracy and precision of the combined use of theranostic imaging biomarkers generated by the UV-A device to predict the propensity of CXL in flattening the Kmax value at 12-months.||||
71838512|NCT05457647|143184981|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of Kmax value at 12-months follow-up visit.||||<0.05
71838513|NCT05457647|143184982|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of ECD value at 12-months follow-up visit.||||<0.05
71838514|NCT05457647|143184983|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of MSER value at 12-months follow-up visit.||||<0.05
71838515|NCT05457647|143184984|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CDVA value at 12-months follow-up visit.||||<0.05
71892588|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.752|STANDARD_ERROR_OF_MEAN|0.254|||TWO_SIDED|95.0|1.053|2.916||||||Comparison at 96 h post first dose||2.916|1.053|
71791682|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.134||0.807|TWO_SIDED|95.0|-0.33|0.26||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.26|-0.33|0.8070
71791683|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.189||0.6828|TWO_SIDED|95.0|-0.59|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.59|0.6828
71791684|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.109||0.8987|TWO_SIDED|95.0|-0.26|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.26|0.8987
71791685|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.117||0.8922|TWO_SIDED|95.0|-0.28|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.28|0.8922
71791686|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.203||0.7555|TWO_SIDED|95.0|-0.39|0.52||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.52|-0.39|0.7555
71791687|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.218||0.1928|TWO_SIDED|95.0|-0.18|0.79||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.79|-0.18|0.1928
71791688|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.161||0.4946|TWO_SIDED|95.0|-0.26|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.49|-0.26|0.4946
71791689|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.196||0.7029|TWO_SIDED|95.0|-0.56|0.4||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.40|-0.56|0.7029
71791690|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.171||0.1085|TWO_SIDED|95.0|-0.68|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.68|0.1085
71791691|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.132||0.3588|TWO_SIDED|95.0|-0.44|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.44|0.3588
71791692|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.151||0.3053|TWO_SIDED|95.0|-0.2|0.53||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.53|-0.20|0.3053
71791693|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.9861|TWO_SIDED|95.0|-0.36|0.36||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.36|-0.36|0.9861
71791694|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6558|TWO_SIDED|95.0|-0.41|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.41|0.6558
71791695|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.145||0.9471|TWO_SIDED|95.0|-0.53|0.51||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.51|-0.53|0.9471
71791696|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.186||0.2136|TWO_SIDED|95.0|-0.77|0.23||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.23|-0.77|0.2136
71791697|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.189||0.6435|TWO_SIDED|95.0|-0.47|0.67||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.67|-0.47|0.6435
71672256|NCT03331796|142862774|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.1||0.21|TWO_SIDED|95.0|-0.8|3.6|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||3.6|-0.8|0.21
71791698|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.086||0.0659|TWO_SIDED|95.0|-0.41|0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.02|-0.41|0.0659
71791699|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.7687|TWO_SIDED|95.0|-0.41|0.31||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.31|-0.41|0.7687
71791700|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.163||0.1061|TWO_SIDED|95.0|-0.73|0.1||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.10|-0.73|0.1061
71672257|NCT03331796|142862775|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.66|TWO_SIDED|95.0|-3.2|2.1|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||2.1|-3.2|0.66
71791701|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.3925|TWO_SIDED|95.0|-0.41|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.19|-0.41|0.3925
71791702|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.161||0.1991|TWO_SIDED|95.0|-0.58|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.58|0.1991
71791703|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.151||0.5176|TWO_SIDED|95.0|-0.45|0.24||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.24|-0.45|0.5176
71791704|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.314|TWO_SIDED|95.0|-0.5|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.18|-0.50|0.3140
71791705|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.171||0.6348|TWO_SIDED|95.0|-0.46|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.29|-0.46|0.6348
71791706|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.165||0.1491|TWO_SIDED|95.0|-0.64|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.12|-0.64|0.1491
71791707|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.192||0.4226|TWO_SIDED|95.0|-0.59|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.59|0.4226
71791708|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.228||0.9778|TWO_SIDED|95.0|-0.49|0.5||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.50|-0.49|0.9778
71791709|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.179||0.9456|TWO_SIDED|95.0|-0.4|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.43|-0.40|0.9456
71791710|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2299|TWO_SIDED|95.0|-0.55|0.15||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.15|-0.55|0.2299
71791711|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.188||0.5069|TWO_SIDED|95.0|-0.54|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.28|-0.54|0.5069
71791712|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.143||0.3524|TWO_SIDED|95.0|-0.45|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.45|0.3524
71791713|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.358||0.4182|TWO_SIDED|95.0|-0.8|1.47||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.47|-0.80|0.4182
71791714|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_DEVIATION|0.326||0.363|TWO_SIDED|95.0|-0.42|1.04||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||1.04|-0.42|0.3630
71672258|NCT03331796|142862775|SUPERIORITY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-4.9|0.5|||Regression, Linear|||a priori threshold for statistical significance = .05||0.5|-4.9|0.11
71672259|NCT03331796|142862776|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.11||0.59|TWO_SIDED|95.0|-0.29|0.17|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.17|-0.29|0.59
71791715|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.263||0.9837|TWO_SIDED|95.0|-0.73|0.74||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.74|-0.73|0.9837
71791716|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.102||0.0974|TWO_SIDED|95.0|-0.04|0.42||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.42|-0.04|0.0974
71838516|NCT05457647|143184985|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of UDVA value at 12-months follow-up visit.||||<0.05
71791717|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.1246|TWO_SIDED|95.0|-0.04|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.27|-0.04|0.1246
71791718|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.119||0.619|TWO_SIDED|95.0|-0.2|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.20|0.6190
71791719|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.635|TWO_SIDED|95.0|-0.39|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.25|-0.39|0.6350
71791720|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164||0.8205|TWO_SIDED|95.0|-0.4|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.40|0.8205
71791721|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.123||0.2959|TWO_SIDED|95.0|-0.42|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.14|-0.42|0.2959
71791722|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.194||0.552|TWO_SIDED|95.0|-0.56|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.32|-0.56|0.5520
71791723|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.22||0.9046|TWO_SIDED|95.0|-0.5|0.45||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.45|-0.50|0.9046
71791724|NCT01082965|143082426|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.125||0.0402|TWO_SIDED|95.0|-0.62|-0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||-0.02|-0.62|0.0402
71791725|NCT01082965|143082427|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|12.11||0.688|TWO_SIDED|95.0|-21.82|31.82||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||31.82|-21.82|0.6880
71791726|NCT01082965|143082427|SUPERIORITY_OR_OTHER||LS Mean Difference|9.79|STANDARD_ERROR_OF_MEAN|9.143||0.3157|TWO_SIDED|95.0|-11.3|30.87||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||30.87|-11.30|0.3157
71791727|NCT01082965|143082427|SUPERIORITY_OR_OTHER||LS Mean Difference|9.86|STANDARD_ERROR_OF_MEAN|8.921||0.3228|TWO_SIDED|95.0|-13.56|33.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||33.28|-13.56|0.3228
71791728|NCT01082965|143082428|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|3.479||0.254|TWO_SIDED|95.0|-12.9|4.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total IR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||4.12|-12.90|0.2540
71791729|NCT01082965|143082428|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.95||0.7684|TWO_SIDED|95.0|-4.17|5.37||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total DR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||5.37|-4.17|0.7684
71791730|NCT01082965|143082429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.059||0.494|TWO_SIDED|95.0|-0.09|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.17|-0.09|0.4940
71791731|NCT01082965|143082429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.057||0.1031|TWO_SIDED|95.0|-0.02|0.22||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.22|-0.02|0.1031
71791732|NCT01082965|143082429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.048||0.3277|TWO_SIDED|95.0|-0.06|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.16|-0.06|0.3277
71791733|NCT01082965|143082429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.029||0.6585|TWO_SIDED|95.0|-0.05|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.05|0.6585
71838517|NCT05457647|143184986|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Assessment of change of CCT value at 12-months follow-up visit.||||<0.05
71791734|NCT01082965|143082429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.033||0.8863|TWO_SIDED|95.0|-0.07|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.08|-0.07|0.8863
71791735|NCT01082965|143082429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.044||0.4388|TWO_SIDED|95.0|-0.06|0.13||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.||0.13|-0.06|0.4388
71791736|NCT02587065|143082430|OTHER||Spearman's correlation coefficient|-0.85||||0.56|TWO_SIDED|95.0|-3.72|2.02|||Mixed-effects REML regression|||Adjusted change of convenience satisfaction domain of TSQM-9.||2.02|-3.72|0.56
71791737|NCT04035161|143082469|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.15|0.16||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.16|-0.15|
71791738|NCT04035161|143082469|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|-0.24|||||TWO_SIDED|95.0|-0.43|-0.05||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||-0.05|-0.43|
71791739|NCT04035161|143082469|SUPERIORITY||Mean Difference (Final Values)|1.82|||||TWO_SIDED|95.0|1.66|1.97||||||"Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||1.97|1.66|
71791740|NCT04035161|143082469|SUPERIORITY||Mean Difference (Final Values)|2.38|||||TWO_SIDED|95.0|2.19|2.56||||||"Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.56|2.19|
71838518|NCT05457647|143184987|OTHER|Paired Wilcoxon signed-rank test was used to compare the distributions preoperatively and 12-months postoperatively. Bonferroni correction was applied to analysis of exploratory outcome measures of stratification groups.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71838519|NCT02683447|143184988|OTHER|Correlation||||||0.039||||||P \< 0.05 is considered statistically significant.|Pearson correlation|||||||0.039
71838520|NCT02683447|143184989|OTHER|Correlation|||||<|0.01||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS correct score||||<0.01
71838521|NCT02683447|143184989|OTHER|Correlation||||||0.322||||||P \< 0.05 is considered statically significant.|Pearson correlation|||ACLS risk score||||0.322
71838522|NCT03115476|143184996|OTHER||Hazard Ratio (HR)|1.43||||0.43|TWO_SIDED|95.0|0.61|3.9|||likelihood ratio test|||Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio||3.9|0.61|0.43
71838523|NCT03115476|143184997|OTHER||Hazard Ratio (HR)|1.99|||<|0.01|TWO_SIDED|95.0|1.17|3.62|||likelihood ratio test|||relative difference between treatment groups (ingenol disoxate gel vs vehicle) expressed as hazard ratio||3.62|1.17|<0.01
71838524|NCT03976362|143185014|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.004|TWO_SIDED|95.0|0.63|0.93||One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||0.93|0.63|0.0040
71838525|NCT03976362|143185015|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5481|TWO_SIDED|95.0|0.83|1.24||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.24|0.83|0.5481
71838526|NCT03976362|143185018|OTHER||Difference in LS Means|0.37||||0.8238|TWO_SIDED|95.0|-2.91|3.66||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.66|-2.91|0.8238
71838527|NCT03976362|143185019|OTHER||Hazard Ratio (HR)|0.87||||0.3083|TWO_SIDED|95.0|0.66|1.14||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.|||1.14|0.66|0.3083
71791741|NCT04035161|143082472|NON_INFERIORITY|A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect (ATE) of the Investigational Product compared to the Active Control (i.e., the upper two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product application bacterial load of the Investigational Product - Active Control should be less than 0.5 log10).|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.08|0.23||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||0.23|-0.08|
71791742|NCT04035161|143082472|SUPERIORITY||Mean Difference (Final Values)|1.99|||||TWO_SIDED|95.0|1.84|2.15||||||"Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate."||2.15|1.84|
71791743|NCT00827983|143082476|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-3.1||||0.37|TWO_SIDED|95.0|-9.9|3.7|||Chi-squared|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||3.7|-9.9|0.37
71791744|NCT00827983|143082477|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.1||||0.37|TWO_SIDED|95.0|-9.87|3.68|||Chi-squared|||||3.68|-9.87|0.37
71791745|NCT00827983|143082478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.33||0.85|TWO_SIDED|95.0|-4.7|5.8|||t-test, 2 sided|||||5.8|-4.7|0.85
71791746|NCT01602380|143082491|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.797||||0.0486|TWO_SIDED|95.0|0.637|0.999||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio \< 1 favours fulvestrant.|If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).||0.999|0.637|0.0486
71791747|NCT01602380|143082492|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.966||||0.7579|TWO_SIDED|95.0|0.773|1.206||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A HR of \<1 favours fulvestrant.|65% OS maturity||1.206|0.773|0.7579
71791748|NCT01602380|143082493|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.074||||0.729|TWO_SIDED|95.0|0.716|1.614||2-sided p-value|Regression, Logistic|||||1.614|0.716|0.7290
71791749|NCT01602380|143082495|SUPERIORITY_OR_OTHER_LEGACY||Rato of EDoR|1.52||||0.0367|TWO_SIDED|95.0|1.03|2.26||2-sided p-value|Method of Ellis et al|||||2.26|1.03|0.0367
71791750|NCT01602380|143082496|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.253||||0.3045|TWO_SIDED|95.0|0.815|1.932||2-sided p-value|Regression, Logistic|||||1.932|0.815|0.3045
71791751|NCT01602380|143082498|SUPERIORITY_OR_OTHER_LEGACY||Ratio of EDoCB|1.26||||0.0561||95.0|0.99|1.59||2-sided p-value|Method of Ellis et al|||||1.59|0.99|0.0561
71791752|NCT01602380|143082499|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.2846|TWO_SIDED|95.0|0.7|1.11||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).||1.11|0.70|0.2846
71892589|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.163|||TWO_SIDED|95.0|0.419|0.803||||||Comparison at 6 h post first dose||0.803|0.419|
71791753|NCT01602380|143082499|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0844|TWO_SIDED|95.0|0.66|1.03||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced/metastatic disease and measurable/non-measurable disease at baseline|A hazard ratio \< 1 favours fulvestrant.|Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).||1.03|0.66|0.0844
71791754|NCT01064401|143082502|SUPERIORITY_OR_OTHER||Rate Ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.469|0.645||Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|||||0.645|0.469|< 0.0001
71791755|NCT01064401|143082502|SUPERIORITY_OR_OTHER||Percent Reduction|45.0|||||TWO_SIDED|95.0|35.5|53.1||||||||53.1|35.5|
71892590|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|0.433|0.996||||||Comparison at 12 h post first dose||0.996|0.433|
71672260|NCT03331796|142862776|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.64|TWO_SIDED|95.0|-0.17|0.28|||Regression, Linear|Adjusted for baseline||a priori threshold for statistical significance = .05||0.28|-0.17|0.64
71791756|NCT01064401|143082503|SUPERIORITY_OR_OTHER||Percent Reduction|54.4|||<|0.0001|TWO_SIDED|95.0|46.9|60.8||Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs \> 35 years).|Negative Binomial Regression|The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.||||60.8|46.9|< 0.0001
71791757|NCT01064401|143082504|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.1575|TWO_SIDED|95.0|0.66|1.07||Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||1.07|0.66|0.1575
71791758|NCT01064401|143082504|SUPERIORITY_OR_OTHER||Percent Reduction|16.1|||||TWO_SIDED|95.0|-7.0|34.2||||||||34.2|-7.0|
71791759|NCT01064401|143082505|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.69||Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS \> 2.5) and baseline age (≤ 35 vs \> 35 years).|Cox Proportional Hazard|||||0.69|0.50|< 0.0001
71791760|NCT01064401|143082505|SUPERIORITY_OR_OTHER||Percent Reduction in Risk of Relapse|40.9|||||TWO_SIDED|95.0|30.8|49.5||||||||49.5|30.8|
71791761|NCT01064401|143082506|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.0176|TWO_SIDED|95.0|0.6|0.95||Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs \> 35 years).|Regression, Logistic|||||0.95|0.60|0.0176
71791762|NCT01064401|143082506|SUPERIORITY_OR_OTHER||Percent Reduction in Odds of Worsening|24.2|||||TWO_SIDED|95.0|4.7|39.6||||||||39.6|4.7|
71791763|NCT02738151|143082533|NON_INFERIORITY|Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|Least Square (LS) Mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.152|0.051||Threshold for significance at 0.025 level.|Mixed Models Analysis||Toujeo vs. Tresiba|A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.||0.051|-0.152|<.0001
71892591|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.747|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|0.477|1.171||||||Comparison at 18 h post first dose||1.171|0.477|
71892592|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.657|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.421|1.024||||||Comparison at 24 h post first dose||1.024|0.421|
71892593|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.759|STANDARD_ERROR_OF_MEAN|0.261|||TWO_SIDED|95.0|0.451|1.279||||||Comparison at 48 h post first dose||1.279|0.451|
71892594|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|0.55|1.701||||||Comparison at 72 h post first dose||1.701|0.550|
71892595|NCT00996840|143306550|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.744|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.45|1.229||||||Comparison at 96 h post first dose||1.229|0.450|
71791764|NCT02738151|143082533|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.052||0.3302|TWO_SIDED|95.0|-0.152|0.051|||Mixed Models Analysis|||Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was \<0 (zero).||0.051|-0.152|0.3302
71791765|NCT03649711|143082568|OTHER|Post treatment values were compared using ANCOVA||||||0.002|||||||ANCOVA|||||||0.002
71892596|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.773|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.607|0.985||||||Comparison at 6 h post first dose||0.985|0.607|
71892597|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.795|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|95.0|0.583|1.084||||||Comparison at 12 h post first dose||1.084|0.583|
71892598|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.778|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|0.533|1.135||||||Comparison at 18 h post first dose||1.135|0.533|
71892599|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.633|STANDARD_ERROR_OF_MEAN|0.193|||TWO_SIDED|95.0|0.43|0.931||||||Comparison at 24 h post first dose||0.931|0.430|
71892600|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.662|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|0.397|1.103||||||Comparison at 48 h post first dose||1.103|0.397|
71892601|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.465|STANDARD_ERROR_OF_MEAN|0.243|||TWO_SIDED|95.0|0.286|0.756||||||Comparison at 72 h post first dose||0.756|0.286|
71892602|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.525|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|95.0|0.295|0.935||||||Comparison at 96 h post first dose||0.935|0.295|
71892603|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.952|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.768|1.18||||||Comparison at 6 h post first dose||1.180|0.768|
71892604|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.965|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.733|1.269||||||Comparison at 12 h post first dose||1.269|0.733|
71892605|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.992|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.71|1.387||||||Comparison at 18 h post first dose||1.387|0.710|
71892606|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.913|STANDARD_ERROR_OF_MEAN|0.171|||TWO_SIDED|95.0|0.649|1.285||||||Comparison at 24 h post first dose||1.285|0.649|
71791766|NCT03649711|143082568|OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||mean changes in values were compared by Wilcoxon rank sum test adjusted for multiple comparisons (Bonferonni method) between CKD-ticagrelor arm, and the non-CKD controls||||0.18
71791767|NCT03649711|143082569|OTHER|||||||0.22|||||||ANCOVA|||CKD groups randomized were compared for post treatment values.||||0.22
71791768|NCT00380978|143082614|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence|Risk Ratio (RR)|1.04||||0.65|TWO_SIDED|95.0|0.9|1.2|||Chi-squared, Corrected|||Group sample sizes of 800 in each group achieve 80% power to detect equivalence when the margin of equivalence extends from 0.1 to 0.25||1.20|0.90|0.65
71791769|NCT00380978|143082615|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||0.63|TWO_SIDED|95.0|0.8|1.2|||Chi-squared|||There rate of instrumented vaginal delivery will be equal in both groups.||1.20|0.80|0.63
71791770|NCT00380978|143082616|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Log Rank|||||||0.047
71791771|NCT00380978|143082617|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Chi-squared|||||||0.35
71791772|NCT00380978|143082618|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.0|||<|0.005|TWO_SIDED|95.0|-4.0|-3.0|||Wilcoxon (Mann-Whitney)|||||-3|-4|<0.005
71791773|NCT00380978|143082619|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
71791774|NCT00380978|143082620|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
71791775|NCT00380978|143082621|SUPERIORITY_OR_OTHER||||||<|0.005||95.0|||||Chi-squared, Corrected|||||||<0.005
71791776|NCT01729754|143082624|SUPERIORITY||Difference in percentages|59.8|||<|0.001|TWO_SIDED|95.0|52.9|65.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||65.9|52.9|<0.001
71791777|NCT01729754|143082624|SUPERIORITY||Difference in percentages|55.5|||<|0.001|TWO_SIDED|95.0|48.3|61.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||61.8|48.3|<0.001
71791778|NCT01729754|143082625|SUPERIORITY||Difference in percentages|54.7|||<|0.001|TWO_SIDED|95.0|47.9|60.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||60.8|47.9|<0.001
71791779|NCT01729754|143082625|SUPERIORITY||Difference in percentages|50.2|||<|0.001|TWO_SIDED|95.0|43.2|56.5||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||56.5|43.2|<0.001
71791780|NCT01729754|143082628|SUPERIORITY||Difference in percentages|19.2|||<|0.001|TWO_SIDED|95.0|11.5|26.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||26.7|11.5|<0.001
71791781|NCT01729754|143082628|SUPERIORITY||Difference in percentages|20.1|||<|0.001|TWO_SIDED|95.0|12.4|27.6||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||27.6|12.4|<0.001
71791782|NCT01729754|143082631|SUPERIORITY||Difference in percentages|24.1|||<|0.001|TWO_SIDED|95.0|16.2|31.7|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||31.7|16.2|<0.001
71791783|NCT01729754|143082631|SUPERIORITY||Difference in percentages|19.6|||<|0.001|TWO_SIDED|95.0|11.7|27.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||27.3|11.7|<0.001
71791784|NCT01729754|143082634|SUPERIORITY||Difference in percentages|35.3|||<|0.001|TWO_SIDED|95.0|29.2|41.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||41.1|29.2|<0.001
71791785|NCT01729754|143082634|SUPERIORITY||Difference in percentages|37.5|||<|0.001|TWO_SIDED|95.0|31.1|43.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights|||43.4|31.1|<0.001
71791786|NCT01729754|143082634|SUPERIORITY||Difference in percentages|15.2|||<|0.001|TWO_SIDED|95.0|8.3|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|8.3|<0.001
71791787|NCT01729754|143082634|SUPERIORITY||Difference in percentages|17.4|||<|0.001|TWO_SIDED|95.0|10.3|24.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||24.4|10.3|<0.001
71791788|NCT01729754|143082635|OTHER||Difference in percentages|27.1|||<|0.001|TWO_SIDED|95.0|19.1|34.7||Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||34.7|19.1|<0.001
71791789|NCT01729754|143082635|OTHER||Difference in percentages|24.9|||<|0.001|TWO_SIDED|95.0|17.0|32.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||32.6|17.0|<0.001
71791790|NCT01729754|143082638|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|7.8|16.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.0|7.8|<0.001
71672261|NCT03331796|142862779|SUPERIORITY|||||||0.768||||||a priori threshold for statistical significance = .05|ANOVA|||||||0.768
71672262|NCT01262872|142862794|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|-7.9|||||TWO_SIDED|95.0|-36.3|14.6||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||14.6|-36.3|
71672263|NCT01262872|142862794|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|6.4|||||TWO_SIDED|95.0|-17.8|25.7||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-17.8|
71672264|NCT01262872|142862794|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|2.5|||||TWO_SIDED|95.0|-22.6|22.5||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||22.5|-22.6|
71791791|NCT01729754|143082638|SUPERIORITY||Difference in percentages|12.4|||<|0.001|TWO_SIDED|95.0|8.5|16.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||16.6|8.5|<0.001
71791792|NCT01729754|143082638|SUPERIORITY||Difference in percentages|7.0||||0.001|TWO_SIDED|95.0|2.8|11.6|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||11.6|2.8|0.001
71892607|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.66|STANDARD_ERROR_OF_MEAN|0.233|||TWO_SIDED|95.0|0.415|1.051||||||Comparison at 48 h post first dose||1.051|0.415|
71892608|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.69|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.445|1.072||||||Comparison at 72 h post first dose||1.072|0.445|
71672265|NCT01262872|142862794|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|4.5|||||TWO_SIDED|95.0|-21.4|25.0||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.0|-21.4|
71677222|NCT04143594|142873014|SUPERIORITY||Difference in LSM|32.0||||0.5492|TWO_SIDED|95.0|-75.0|140.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||140|-75|0.5492
71791793|NCT01729754|143082638|SUPERIORITY||Difference in percentages|7.6|||<|0.001|TWO_SIDED|95.0|3.3|12.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.3|3.3|<0.001
71791794|NCT01729754|143082639|SUPERIORITY||Difference in percentages|15.7|||<|0.001|TWO_SIDED|95.0|9.4|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.1|9.4|<0.001
71892609|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.724|STANDARD_ERROR_OF_MEAN|0.268|||TWO_SIDED|95.0|0.423|1.239||||||Comparison at 96 h post first dose||1.239|0.423|
71892610|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|0.789|1.144||||||Comparison at 6 h post first dose||1.144|0.789|
71892611|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.985|STANDARD_ERROR_OF_MEAN|0.119|||TWO_SIDED|95.0|0.777|1.249||||||Comparison at 12 h post first dose||1.249|0.777|
71892612|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.067|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.797|1.428||||||Comparison at 18 h post first dose||1.428|0.797|
71892613|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.922|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|0.686|1.239||||||Comparison at 24 h post first dose||1.239|0.686|
71677223|NCT04143594|142873014|SUPERIORITY||Difference in LSM|17.0||||0.722|TWO_SIDED|95.0|-80.0|115.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|Difference in LSM||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||115|-80|0.7220
71791795|NCT01729754|143082639|SUPERIORITY||Difference in percentages|11.7|||<|0.001|TWO_SIDED|95.0|5.6|17.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||17.9|5.6|<0.001
71791796|NCT01729754|143082643|OTHER||Difference in least squares means|-8.2|||<|0.001|TWO_SIDED|95.0|-9.3|-7.2|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.2|-9.3|<0.001
71791797|NCT01729754|143082643|OTHER||Difference in least squares means|-8.3|||<|0.001|TWO_SIDED|95.0|-9.3|-7.3|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-7.3|-9.3|<0.001
71791798|NCT01729754|143082643|OTHER||Difference in least squares means|-1.3||||0.002|TWO_SIDED|95.0|-2.1|-0.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.5|-2.1|0.002
71791799|NCT01729754|143082643|OTHER||Difference in least squares means|-1.4||||0.001|TWO_SIDED|95.0|-2.2|-0.6|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-0.6|-2.2|0.001
71791800|NCT01729754|143082644|OTHER||Difference in least squares means|-1.7|||<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.0|-2.4|<0.001
71791801|NCT01729754|143082644|OTHER||Difference in least squares means|-2.2|||<|0.001|TWO_SIDED|95.0|-2.9|-1.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-1.5|-2.9|<0.001
71791802|NCT01729754|143082647|OTHER||Difference in percentages|39.3|||<|0.001|TWO_SIDED|95.0|31.8|46.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||46.1|31.8|<0.001
71791803|NCT01729754|143082647|OTHER||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|24.5|39.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||39.1|24.5|<0.001
71791804|NCT01729754|143082647|OTHER||Difference in percentages|11.9||||0.003|TWO_SIDED|95.0|4.1|19.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||19.5|4.1|0.003
71791805|NCT01729754|143082647|OTHER||Difference in percentages|4.8||||0.221|TWO_SIDED|95.0|-2.9|12.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||12.5|-2.9|0.221
71791806|NCT01729754|143082648|OTHER||Difference in percentages|25.7|||<|0.001|TWO_SIDED|95.0|17.7|33.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||33.4|17.7|<0.001
71791807|NCT01729754|143082648|OTHER||Difference in percentages|15.0|||<|0.001|TWO_SIDED|95.0|6.9|22.9|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.|||22.9|6.9|<0.001
71791808|NCT00773292|143082658|OTHER|change from baseline||||||0.24|||||||t-test, 2 sided|||||||0.24
71791809|NCT00112502|143082665|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.7||||||||1.7|0.8|
71791810|NCT00112502|143082666|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.6|1.2||||||||1.2|0.6|
71791811|NCT00112502|143082667|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.9|1.8||||||||1.8|0.9|
71791812|NCT00112502|143082668|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.6|1.3||||||||1.3|0.6|
71791813|NCT00112502|143082670|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.7|1.5||||||||1.5|0.7|
71791814|NCT00112502|143082671|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
71791815|NCT00112502|143082672|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.8|1.8||||||||1.8|0.8|
71791816|NCT00112502|143082673|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1||||||||1.1|0.5|
71791817|NCT00870363|143082680|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Kruskal-Wallis|||||||>0.05
71791818|NCT01959542|143082695|OTHER|Pearson's product-moment correlation|Pearson's product-moment correlation|-0.53||||0.09|TWO_SIDED|95.0|-86.0|0.1|||Pearson's product-moment correlation|||||0.10|-086|0.09
71791819|NCT01959542|143082696|OTHER||Pearson's product-moment correlation|-0.62||||0.03|TWO_SIDED|95.0|-0.62|-0.15|||Pearson's product-moment correlation|Pearson's product moment correlation||||-0.15|-0.62|0.03
71791820|NCT03388138|143082718|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0017|STANDARD_ERROR_OF_MEAN|0.01169|||TWO_SIDED|95.0|-0.021|0.025|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.025|-0.021|
71791821|NCT03388138|143082719|NON_INFERIORITY|Non-inferiority of the etafilcon A with ketotifen lens relative to the etafilcon A lens was established if the upper limit of the 95% confidence interval was below 0.1 logMAR.|Least-Square Mean Difference|0.0007|STANDARD_ERROR_OF_MEAN|0.01158|||TWO_SIDED|95.0|-0.022|0.024|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as etafilcon A with ketotifen - etafilcon A|||0.024|-0.022|
71791822|NCT01268111|143082722|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.4
71892614|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.866|STANDARD_ERROR_OF_MEAN|0.198|||TWO_SIDED|95.0|0.583|1.287||||||Comparison at 48 h post first dose||1.287|0.583|
71892615|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.649|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.444|0.95||||||Comparison at 72 h post first dose||0.950|0.444|
71892616|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.722|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.457|1.14||||||Comparison at 96 h post first dose||1.140|0.457|
71892617|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.897|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|95.0|0.748|1.075||||||Comparison at 6 h post first dose||1.075|0.748|
71892618|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.887|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.703|1.119||||||Comparison at 12 h post first dose||1.119|0.703|
71892619|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.846|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|0.638|1.123||||||Comparison at 18 h post first dose||1.123|0.638|
71672266|NCT01262872|142862794|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|5.3|||||TWO_SIDED|95.0|-19.2|24.8||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||24.8|-19.2|
71791823|NCT00587483|143082736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.37||An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.|Regression, Logistic|||The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.||1.37|0.48|0.427
71791824|NCT00587483|143082736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.117|TWO_SIDED|95.0|0.39|1.11|||Regression, Logistic|||||1.11|0.39|0.117
71791825|NCT00587483|143082736|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.433|TWO_SIDED|95.0|0.47|1.37|||Regression, Logistic|||||1.37|0.47|0.433
71791826|NCT00587483|143082737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.215|TWO_SIDED|95.0|0.45|1.19|||Regression, Logistic|||||1.19|0.45|0.215
71791827|NCT00587483|143082737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.008|TWO_SIDED|95.0|0.32|0.84|||Regression, Logistic|||||0.84|0.32|0.008
71791828|NCT00587483|143082737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.424|TWO_SIDED|95.0|0.52|1.33|||Regression, Logistic|||||1.33|0.52|0.424
71791829|NCT02063516|143082743|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).||||0.04
71791830|NCT02063516|143082744|SUPERIORITY_OR_OTHER|||||||0.836|TWO_SIDED|95.0|||||Chi-squared|||||||0.836
71791831|NCT02063516|143082745|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 30 minutes to maintain cuff pressure 60cmH2O||||0.0035
71791832|NCT02063516|143082745|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 60 minutes to maintain cuff pressure 60cmH2O||||0.003
71791833|NCT02063516|143082745|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O||||0.0042
71791834|NCT02063516|143082745|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||t-test, 2 sided|||Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O||||0.004
71892620|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.812|STANDARD_ERROR_OF_MEAN|0.145|||TWO_SIDED|95.0|0.609|1.084||||||Comparison at 24 h post first dose||1.084|0.609|
71892621|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.58|STANDARD_ERROR_OF_MEAN|0.194|||TWO_SIDED|95.0|0.394|0.855||||||Comparison at 48 h post first dose||0.855|0.394|
71892622|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.439|STANDARD_ERROR_OF_MEAN|0.188|||TWO_SIDED|95.0|0.301|0.639||||||Comparison at 72 h post first dose||0.639|0.301|
71892623|NCT00996840|143306551|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.451|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|0.285|0.714||||||Comparison at 96 h post first dose||0.714|0.285|
71892624|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.85|STANDARD_ERROR_OF_MEAN|0.137|||TWO_SIDED|95.0|0.646|1.119||||||Comparison at 6 h post first dose||1.119|0.646|
71892625|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.072|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|95.0|0.814|1.411||||||Comparison at 12 h post first dose||1.411|0.814|
71892626|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.08|STANDARD_ERROR_OF_MEAN|0.157|||TWO_SIDED|95.0|0.79|1.478||||||Comparison at 18 h post first dose||1.478|0.790|
71892627|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.951|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|0.715|1.266||||||Comparison at 24 h post first dose||1.266|0.715|
71892628|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.918|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|95.0|0.655|1.285||||||Comparison at 48 h post first dose||1.285|0.655|
71672267|NCT01262872|142862794|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|0.6|||||TWO_SIDED|95.0|-24.9|20.9||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||20.9|-24.9|
71677224|NCT04143594|142873014|SUPERIORITY||Difference in LSM|-4.0||||0.9486|TWO_SIDED|95.0|-118.0|110.0||P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|ANOVA||Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (\<= 100,000 copies/mL or \> 100,000 copies/mL).|||110|-118|0.9486
71791835|NCT02063854|143082746|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.1346|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.1346
71791836|NCT02063854|143082746|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.6711|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.||||||0.6711
71791837|NCT02063854|143082746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|95.0|-1.92|0.001||||||||0.001|-1.920|
71791838|NCT02063854|143082746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-2.617|-0.794||||||||-0.794|-2.617|
71791839|NCT02063854|143082746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|-0.166|1.658||||||||1.658|-0.166|
71791840|NCT03538158|143082759|SUPERIORITY||Slope|5.7||||0.82|TWO_SIDED|95.0|-287.7|299.1|||Mixed Models Analysis|F(2,131)=.07||||299.1|-287.7|.82
71791841|NCT03538158|143082760|SUPERIORITY||Slope|0.5||||0.97|TWO_SIDED|95.0|-3.5|4.4|||Mixed Models Analysis|F(2,75)=.03||||4.4|-3.5|.97
71791842|NCT00930579|143082765|OTHER|This study used two-sided t-tests to compare changes within group- before and after metformin treatment.|Mean Difference (Final Values)|-0.006||||0.98|TWO_SIDED||||||paired t-test|||Null hypothesis: there will be no statistically significant change between the amount of Ki-67 (protein involved in cell proliferation) in participants' tumor cells before and after taking the prescribed dose of Metformin, as measured at the 5% significance level.||||0.98
71791843|NCT02255981|143082777|OTHER|Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.|Mean Difference (Final Values)|15.392|||<|0.05|TWO_SIDED|95.0||||"Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.~It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up."|t-test, 1 sided|From this estimation, it is induced that there are differences in results before and after the treatment.|The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.|"Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.~Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different."|The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.|||<0.05
71791844|NCT00525733|143082819|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Chi-squared|||||||0.46
71791845|NCT03194555|143082864|SUPERIORITY||Risk Difference (RD)|-2.17||||0.4267|TWO_SIDED|95.0|-3.67|8.01|||Chi-squared|||||8.01|-3.67|0.4267
71838528|NCT03976362|143185020|OTHER||Difference in Least Square Means|1.68||||0.4686|TWO_SIDED|95.0|-2.87|6.23||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||6.23|-2.87|0.4686
71892629|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.012|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.735|1.395||||||Comparison at 72 h post first dose||1.395|0.735|
71892630|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.168|STANDARD_ERROR_OF_MEAN|0.169|||TWO_SIDED|95.0|0.831|1.64||||||Comparison at 96 h post first dose||1.640|0.831|
71677225|NCT00282113|142873042|SUPERIORITY_OR_OTHER||||||>|0.5||95.0|||||Mixed-effects regression|||||||>0.5
71791846|NCT03194555|143082865|SUPERIORITY||Risk Difference (RD)|2.0||||0.268|TWO_SIDED|95.0|-18.46|66.83|||Chi-squared|||||66.83|-18.46|0.268
71791847|NCT03194555|143082866|SUPERIORITY||Risk Difference (RD)|3.0||||0.0926|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.0926
71677226|NCT00282113|142873043|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71677227|NCT00282113|142873044|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71791848|NCT03194555|143082867|SUPERIORITY||Risk Difference (RD)|2.0||||0.2894|TWO_SIDED|95.0|-17.2|67.4|||Chi-squared|||||67.4|-17.2|0.2894
71791849|NCT03194555|143082868|SUPERIORITY||Risk Difference (RD)|-1.83||||0.5724|TWO_SIDED|95.0|-5.1557|8.8157|||Chi-squared|||||8.8157|-5.1557|0.5724
71791850|NCT03194555|143082869|SUPERIORITY||Risk Difference (RD)|-9.84||||0.2998|TWO_SIDED|95.0|-11.15|30.83|||Chi-squared|||||30.83|-11.15|0.2998
71791851|NCT03194555|143082870|SUPERIORITY||Risk Difference (RD)|-11.67||||0.2673|TWO_SIDED||||||Chi-squared|||||||0.2673
71838529|NCT03976362|143185021|OTHER||Hazard Ratio (HR)|1.01||||0.9174|TWO_SIDED|95.0|0.76|1.35||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.35|0.76|0.9174
71791852|NCT03194555|143082873|SUPERIORITY||Risk Difference (RD)|28.76||||0.3527|TWO_SIDED|95.0|-94.5005|36.9805|||Chi-squared|||||36.9805|-94.5005|0.3527
71791853|NCT03194555|143082874|SUPERIORITY||Risk Difference (RD)|-1.95||||0.5246|TWO_SIDED||||||Chi-squared|||||||0.5246
71791854|NCT03194555|143082876|SUPERIORITY||Risk Difference (RD)|0.34||||0.8649|TWO_SIDED||||||Chi-squared|||||||0.8649
71791855|NCT03255382|143082884|OTHER||Adjusted percentage difference|73.3|||<|0.001|TWO_SIDED|95.0|61.3|85.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy \[yes/no\]).||85.3|61.3|< 0.001
71791856|NCT03255382|143082885|OTHER||Adjusted percentage difference|46.8|||<|0.001|TWO_SIDED|95.0|32.8|60.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.8|32.8|< 0.001
71791857|NCT03255382|143082886|OTHER||Adjusted percentage difference|63.4|||<|0.001|TWO_SIDED|95.0|50.2|76.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||76.6|50.2|< 0.001
71791858|NCT03255382|143082887|OTHER||Adjusted percentage difference|53.1|||<|0.001|TWO_SIDED|95.0|40.4|65.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||65.7|40.4|< 0.001
71791859|NCT03255382|143082888|OTHER||Adjusted percentage difference|39.6|||<|0.001|TWO_SIDED|95.0|27.3|51.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.9|27.3|< 0.001
71791860|NCT03255382|143082889|OTHER||Adjusted percentage difference|36.3|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||48.5|24.1|< 0.001
71791861|NCT03255382|143082890|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|33.7|59.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.0|33.7|< 0.001
71791862|NCT03255382|143082891|OTHER||Adjusted percentage difference|9.9||||0.047|TWO_SIDED|95.0|0.1|19.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||19.7|0.1|0.047
71791863|NCT03255382|143082892|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
71791864|NCT03255382|143082893|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.9|53.3|< 0.001
71791865|NCT03255382|143082894|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.5|53.8|< 0.001
71791866|NCT03255382|143082895|OTHER||Adjusted percentage difference|56.5|||<|0.001|TWO_SIDED|95.0|43.0|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.0|< 0.001
71791867|NCT03255382|143082896|OTHER||Adjusted percentage difference|64.8|||<|0.001|TWO_SIDED|95.0|52.5|77.2|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||77.2|52.5|< 0.001
71791868|NCT03255382|143082897|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
71791869|NCT03255382|143082898|OTHER||Adjusted percentage difference|36.6|||<|0.001|TWO_SIDED|95.0|23.8|49.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||49.3|23.8|< 0.001
71791870|NCT03255382|143082899|OTHER||Adjusted percentage difference|56.6|||<|0.001|TWO_SIDED|95.0|43.2|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.0|43.2|< 0.001
71791871|NCT03255382|143082900|OTHER||Adjusted percentage difference|64.9|||<|0.001|TWO_SIDED|95.0|51.5|78.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||78.3|51.5|< 0.001
71791872|NCT03255382|143082901|OTHER||Adjusted percentage difference|66.6|||<|0.001|TWO_SIDED|95.0|53.3|79.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||79.8|53.3|< 0.001
71791873|NCT03255382|143082902|OTHER||Adjusted percentage difference|0.0||||0.991|TWO_SIDED|95.0|-2.0|2.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||2.1|-2.0|0.991
71791874|NCT03255382|143082903|OTHER||Adjusted percentage difference|3.3||||0.323|TWO_SIDED|95.0|-3.2|9.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||9.8|-3.2|0.323
71791875|NCT03255382|143082904|OTHER||Adjusted percentage difference|21.5|||<|0.001|TWO_SIDED|95.0|10.4|32.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||32.6|10.4|< 0.001
71791876|NCT03255382|143082905|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.5|20.7|< 0.001
71791877|NCT03255382|143082906|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
71791878|NCT03255382|143082907|OTHER||Adjusted percentage difference|44.7|||<|0.001|TWO_SIDED|95.0|30.9|58.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||58.5|30.9|< 0.001
71791879|NCT03255382|143082908|OTHER||Least Squares Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|0.825|<|0.001|TWO_SIDED|95.0|-8.82|-5.56|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-5.56|-8.82|< 0.001
71892631|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.912|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|95.0|0.713|1.167||||||Comparison at 6 h post first dose||1.167|0.713|
71892632|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.963|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.753|1.233||||||Comparison at 12 h post first dose||1.233|0.753|
71677228|NCT00474201|142873052|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|Students paired, two-tailed T-test||"Null hypothesis: lopinavir-ritonavir does not alter gemfibrozil pharmacokinetics.~A sample size of 13 healthy subjects yielded 81% power to detect a clinically relevant change of 30% in gemfibrozil AUC with concomitant lopinavir-ritonavir (alpha = 0.05; beta = 0.2). Gemfibrozil pharmacokinetic parameters derived pre- and post lopinavir-ritonavir exposure (Days 1 and 14, respectively) were compared using a paired Students t test."||||<0.0001
71791880|NCT03255382|143082909|OTHER||Least Squares Mean Difference|-9.58|STANDARD_ERROR_OF_MEAN|0.936|<|0.001|TWO_SIDED|95.0|-11.43|-7.72|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.72|-11.43|< 0.001
71791881|NCT03255382|143082910|OTHER||Least Squares Mean Difference|-8.8|STANDARD_ERROR_OF_MEAN|0.972|<|0.001|TWO_SIDED|95.0|-10.72|-6.87|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.87|-10.72|< 0.001
71791882|NCT03255382|143082911|OTHER||Least Squares Mean Difference|-7.78|STANDARD_ERROR_OF_MEAN|0.958|<|0.001|TWO_SIDED|95.0|-9.68|-5.88|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.88|-9.68|< 0.001
71791883|NCT03255382|143082912|OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|1.101|<|0.001|TWO_SIDED|95.0|-10.07|-5.71|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.71|-10.07|< 0.001
71791884|NCT03255382|143082913|OTHER||Least Squares Mean Difference|-8.39|STANDARD_ERROR_OF_MEAN|1.175|<|0.001|TWO_SIDED|95.0|-10.71|-6.06|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.06|-10.71|< 0.001
71791885|NCT03255382|143082914|OTHER||Adjusted percentage difference|29.7|||<|0.001|TWO_SIDED|95.0|17.1|42.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||42.4|17.1|< 0.001
71791886|NCT03255382|143082915|OTHER||Adjusted percentage difference|66.7|||<|0.001|TWO_SIDED|95.0|53.4|80.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||80.0|53.4|< 0.001
71791887|NCT03255382|143082916|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.8|42.7|< 0.001
71791888|NCT03255382|143082917|OTHER||Adjusted percentage difference|59.9|||<|0.001|TWO_SIDED|95.0|46.3|73.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||73.6|46.3|< 0.001
71791889|NCT03255382|143082918|OTHER||Adjusted percentage difference|44.9|||<|0.001|TWO_SIDED|95.0|30.8|59.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||59.1|30.8|< 0.001
71791890|NCT03255382|143082919|OTHER||Adjusted percentage difference|55.0|||<|0.001|TWO_SIDED|95.0|41.2|68.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||68.8|41.2|< 0.001
71791891|NCT03255382|143082920|OTHER||Adjusted percentage difference|1.7||||0.392|TWO_SIDED|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||5.4|-2.1|0.392
71791892|NCT03255382|143082921|OTHER||Adjusted percentage difference|8.4||||0.048|TWO_SIDED|95.0|0.1|16.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||16.7|0.1|0.048
71791893|NCT03255382|143082922|OTHER||Adjusted percentage difference|18.3||||0.001|TWO_SIDED|95.0|7.1|29.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||29.5|7.1|0.001
71791894|NCT03255382|143082923|OTHER||Adjusted percentage difference|33.0|||<|0.001|TWO_SIDED|95.0|20.2|45.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||45.9|20.2|< 0.001
71791895|NCT03255382|143082924|OTHER||Adjusted percentage difference|41.3|||<|0.001|TWO_SIDED|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||55.3|27.3|< 0.001
71791896|NCT03255382|143082925|OTHER||Adjusted percentage difference|46.4|||<|0.001|TWO_SIDED|95.0|32.6|60.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||60.1|32.6|< 0.001
71791897|NCT03255382|143082926|OTHER||Adjusted percentage difference|19.8||||0.001|TWO_SIDED|95.0|7.6|31.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||31.9|7.6|0.001
71791898|NCT03255382|143082927|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|25.0|51.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||51.5|25.0|< 0.001
71791899|NCT03255382|143082928|OTHER||Least Squares Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.0|-4.5|< 0.001
71791900|NCT03255382|143082929|OTHER||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-5.1|-2.7|||van Elteren test|||P-values were calculated by stratified van Elteren test.||-2.7|-5.1|< 0.001
71791901|NCT03255382|143082930|OTHER||Least Squares Mean Difference|1.146|||<|0.001|TWO_SIDED|95.0|0.764|1.528|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.528|0.764|< 0.001
71791902|NCT03255382|143082931|OTHER||Least Squares Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.936|1.704|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||1.704|0.936|< 0.001
71791903|NCT03255382|143082932|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|-3.6|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.6|< 0.001
71791904|NCT03255382|143082933|OTHER||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|-4.3|-1.6|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.6|-4.3|< 0.001
71892633|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.917|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.693|1.214||||||Comparison at 18 h post first dose||1.214|0.693|
71791905|NCT03255382|143082934|OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.307||0.352|TWO_SIDED|95.0|-0.9|0.32|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.32|-0.90|0.352
71791906|NCT03255382|143082935|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.296||0.315|TWO_SIDED|95.0|-0.88|0.29|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.29|-0.88|0.315
71791907|NCT03255382|143082936|OTHER||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-6.9|-2.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-2.7|-6.9|< 0.001
71677229|NCT02784613|142873053|SUPERIORITY|||||||0.05||||||Differences in pre- and post-treatment scores were compared using Wilcoxon signed-rank test for non-parametric matched pairs. All tests of significance were 2-tailed. All analyses were performed in Stata®, version 13.|t-test, 2 sided|||||||0.05
71791908|NCT03255382|143082937|OTHER||Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-12.6|-6.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.1|-12.6|< 0.001
71791909|NCT03255382|143082938|OTHER||Least Squares Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-13.2|-7.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.2|-13.2|< 0.001
71791910|NCT03255382|143082939|OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|1.51|<|0.001|TWO_SIDED|95.0|-12.8|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.8|< 0.001
71791911|NCT03255382|143082940|OTHER||Least Squares Mean Difference|-9.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-12.4|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-6.8|-12.4|< 0.001
71791912|NCT03255382|143082941|OTHER||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-12.9|-7.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-7.1|-12.9|< 0.001
71791913|NCT03255382|143082942|OTHER||Least Squares Mean Difference|4.49|STANDARD_ERROR_OF_MEAN|1.385||0.002|TWO_SIDED|95.0|1.74|7.23|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.23|1.74|0.002
71791914|NCT03255382|143082943|OTHER||Least Squares Mean Difference|4.63|STANDARD_ERROR_OF_MEAN|1.322|<|0.001|TWO_SIDED|95.0|2.01|7.25|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||7.25|2.01|< 0.001
71791915|NCT03255382|143082944|OTHER||Least Squares Mean Difference|6.66|STANDARD_ERROR_OF_MEAN|1.787|<|0.001|TWO_SIDED|95.0|3.11|10.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||10.20|3.11|< 0.001
71791916|NCT03255382|143082945|OTHER||Least Squares Mean Difference|7.85|STANDARD_ERROR_OF_MEAN|1.784|<|0.001|TWO_SIDED|95.0|4.31|11.38|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||11.38|4.31|< 0.001
71791917|NCT03255382|143082946|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.7|-1.2|< 0.001
71791918|NCT03255382|143082947|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.3|-0.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.8|-1.3|< 0.001
71791919|NCT03255382|143082948|OTHER||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|-3.2|-0.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-0.9|-3.2|< 0.001
71791920|NCT03255382|143082949|OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.1|-3.5|< 0.001
71791921|NCT03255382|143082950|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-4.3|-1.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.9|-4.3|< 0.001
71791922|NCT03255382|143082951|OTHER||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|-4.4|-1.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-1.8|-4.4|< 0.001
71791923|NCT03255382|143082952|OTHER||Adjusted percentage difference|38.3|||<|0.001|TWO_SIDED|95.0|23.6|53.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||53.1|23.6|< 0.001
71791924|NCT03255382|143082953|OTHER||Adjusted percentage difference|56.8|||<|0.001|TWO_SIDED|95.0|42.7|70.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy \[yes/no\]).||70.9|42.7|< 0.001
71791925|NCT03255382|143082954|OTHER||Least Squares Mean Difference|-7.4|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|-9.6|-5.1|||ANCOVA|||P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.||-5.1|-9.6|< 0.001
71791926|NCT03255382|143082955|OTHER||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|-9.7|-5.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.5|-9.7|< 0.001
71791927|NCT03255382|143082956|OTHER||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|-9.0|-4.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-4.1|-9.0|< 0.001
71677230|NCT01582178|142873071|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Fisher Exact|||||||0.89
71791928|NCT03255382|143082957|OTHER||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.53|<|0.001|TWO_SIDED|95.0|-11.1|-5.0|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||-5.0|-11.1|< 0.001
71672268|NCT01262872|142862795|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.6|||||TWO_SIDED|95.0|-18.2|26.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||26.2|-18.2|
71672269|NCT01262872|142862795|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.3|||||TWO_SIDED|95.0|-18.0|25.7||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||25.7|-18.0|
71791929|NCT03255382|143082958|OTHER||Least Squares Mean Difference|0.087|STANDARD_ERROR_OF_MEAN|0.0215|<|0.001|TWO_SIDED|95.0|0.045|0.13|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.130|0.045|< 0.001
71791930|NCT03255382|143082959|OTHER||Least Squares Mean Difference|0.059|STANDARD_ERROR_OF_MEAN|0.0186||0.002|TWO_SIDED|95.0|0.022|0.096|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||0.096|0.022|0.002
71791931|NCT03255382|143082960|OTHER||Least Squares Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|9.4|20.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||20.5|9.4|< 0.001
71791932|NCT03255382|143082961|OTHER||Least Squares Mean Difference|16.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|11.4|22.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and treatment in the model.||22.2|11.4|< 0.001
71791933|NCT03255382|143082962|OTHER||Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-16.6|-6.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-6.2|-16.6|< 0.001
71791934|NCT03255382|143082963|OTHER||Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.1|-8.4|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-8.4|-19.1|< 0.001
71791935|NCT03255382|143082964|OTHER||Least Squares Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-24.8|-9.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-9.8|-24.8|< 0.001
71791936|NCT03255382|143082965|OTHER||Least Squares Mean Difference|-21.5|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-28.8|-14.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy \[yes/no\]), baseline value, and the treatment in this model.||-14.2|-28.8|< 0.001
71791937|NCT03011307|143082972|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in score on a scale|0.1||||0.75|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.2|0|0.75
71791938|NCT03011307|143082973|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|0.1||||0.057|TWO_SIDED|95.0|0.0|0.2||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||0.2|0.0|0.057
71813327|NCT01181726|143129084|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.77|||||TWO_SIDED|90.0|93.92|101.78|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.78|93.92|
71813328|NCT01181726|143129085|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.71|||||TWO_SIDED|90.0|94.42|105.3|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||105.30|94.42|
71677231|NCT03852628|142873075|SUPERIORITY||Odds Ratio (OR)|0.17||||0.08|TWO_SIDED|95.0|0.02|1.22|||Mixed Models Analysis|Modeled the probability of having a reduction in AUD||The Placebo arm served as the reference group.||1.22|0.02|0.08
71677232|NCT03852628|142873076|SUPERIORITY||Odds Ratio (OR)|0.76||||0.69|TWO_SIDED|95.0|0.2|2.97|||Mixed Models Analysis|Modeled the probability of reduction in PTSD symptom.||The placebo arm served as the reference group.||2.97|0.20|0.690
71791939|NCT03011307|143082974|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference in Daily Steps|-402.0||||0.41|TWO_SIDED|95.0|-1358.0|553.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||553|-1358|0.41
71791940|NCT03011307|143082975|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|344.0|||<|0.001|TWO_SIDED|95.0|173.0|515.0||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Slope Difference|||"The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.~The slope is the number of daily steps divided by the natural log of time in days."||515|173|<0.001
71791941|NCT03011307|143082976|SUPERIORITY|A likelihood-ratio test for change in World Health Organization Disability Assessment Score 2.0 value was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Intercept Difference: score on a scale|-5.9||||0.002|TWO_SIDED|95.0|-9.5|-2.3||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline World Health Organization Disability Assessment Score 2.0 value, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-2.3|-9.5|0.002
71791942|NCT03011307|143082977|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference|1.5||||0.001|TWO_SIDED|95.0|0.6|2.4||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||2.4|0.6|0.001
71791943|NCT03011307|143082978|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Mean Difference (Final Values)|0.00035||||0.537|TWO_SIDED|95.0|-0.00085|0.0015||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Intercept difference: Opioid probability|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||.0015|-.00085|0.537
71791944|NCT03011307|143082979|SUPERIORITY|A likelihood-ratio test for change in pain was conducted for each outcome comparing a model with and without oxytocin treatment group. A statistically significant result is interpreted as evidence to support that the oxytocin treatment impacts some element of change after surgery (i.e, intercept or slope).|Slope Difference: Opioid probability|-0.166||||0.01|TWO_SIDED|95.0|-0.172|-0.16||P value not adjusted for multiple comparisons, with threshold of statistical significance set at \<0.05|Mixed Models Analysis|||The estimates were conducted using a linear mixed effects model contrasting differences in the oxytocin group versus placebo. In all cases, these differences are adjusted for prognostic variables including baseline pain, baseline opioid use, age, sex, baseline PROMIS depression and number of other painful conditions.||-0.160|-0.172|0.010
71791945|NCT03011307|143082980|SUPERIORITY||Mean Difference (Net)|3.0|STANDARD_DEVIATION|14.0||0.55|TWO_SIDED||||||Regression, Linear|||Scores were compared statistically at baseline and 2 months between groups using a generalized linear model with time as a fixed factor.||||.55
71791946|NCT03011307|143082981|SUPERIORITY||Mean Difference (Net)|1.2|STANDARD_DEVIATION|2.2||0.46|TWO_SIDED||||||Regression, Linear|||Groups were compared over time from baseline to 2 months using a generalized linear model with time as a fixed factor.||||0.46
71791947|NCT03011307|143082982|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.84||0.38|TWO_SIDED||||||Regression, Linear|||Groups were compared between preoperative and 2 month postoperative sessions using linear regression with time as a fixed factor.||||0.38
71791948|NCT01464346|143083003|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|88.01|STANDARD_ERROR_OF_MEAN|1.2|<|0.05|TWO_SIDED|95.0|85.69|90.33|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||90.33|85.69|<0.05
71791949|NCT01464346|143083004|SUPERIORITY_OR_OTHER||Intercept from ANCOVA as agreement rate|90.52|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|88.77|92.28|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept||||92.28|88.77|< 0.05
71791950|NCT02295995|143083016|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
71791951|NCT02295995|143083017|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
71791952|NCT02295995|143083018|OTHER|||||||||||||||||The between-group difference at 12 weeks \[mean difference (MD) and 95% Confidence Interval\] was calculated for all outcome measures. Cohen's d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50|Cohen's d calculated as the change from baseline to 12 weeks in both groups.|||
71791953|NCT01787175|143083030|SUPERIORITY_OR_OTHER||Difference in time to complete A&P|-17.73||||0.047|TWO_SIDED|95.0|-35.24|-0.23|||Mixed-effects linear model|||Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||-0.23|-35.24|0.047
71791954|NCT01787175|143083031|SUPERIORITY_OR_OTHER||Value of problem scores for A&P complete|0.04||||0.15|TWO_SIDED|95.0|-0.01|0.09|||Mixed-effects linear model|||Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||0.09|-0.01|0.15
71791955|NCT01787175|143083032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.005|TWO_SIDED|95.0|1.22|2.98|||Regression, Logistic|||Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).||2.98|1.22|0.005
71791956|NCT02113956|143083034|SUPERIORITY||Incident Rate Ratio (IRR)|1.42|||||TWO_SIDED|95.0|0.79|2.57|||Poisson regression||Adjusted for age and baseline number of condomless sex acts|||2.57|0.79|
71791957|NCT02113956|143083035|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.12|0.36|
71838530|NCT03976362|143185022|OTHER||Difference in Least Square Means|3.83||||0.0245|TWO_SIDED|95.0|0.5|7.16||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||7.16|0.50|0.0245
71838531|NCT03976362|143185023|OTHER||Hazard Ratio (HR)|1.24||||0.2133|TWO_SIDED|95.0|0.88|1.75||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.75|0.88|0.2133
71838532|NCT03976362|143185024|OTHER||Hazard Ratio (HR)|0.18||||0.9381|TWO_SIDED|95.0|-4.27|4.62||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||4.62|-4.27|0.9381
71892634|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.87|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|95.0|0.673|1.123||||||Comparison at 24 h post first dose||1.123|0.673|
71791958|NCT02113956|143083036|SUPERIORITY||Incident Rate Ratio|0.95|||||TWO_SIDED|95.0|0.45|2.02|||Poisson||||Adjusted for age and baseline number of condomless sex acts|2.02|0.45|
71791959|NCT02113956|143083037|SUPERIORITY||Incident Rate Ratio (IRR)|0.62|||||TWO_SIDED|95.0|0.12|3.18|||Poisson||||Adjusted for age and baseline number of condomless sex acts|3.18|0.12|
71791960|NCT02113956|143083038|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.23|0.997|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|0.997|0.23|
71838533|NCT03976362|143185025|OTHER||Hazard Ratio (HR)|0.97||||0.8464|TWO_SIDED|95.0|0.72|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.72|0.8464
71892635|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.141|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|95.0|0.84|1.55||||||Comparison at 48 h post first dose||1.550|0.840|
71791961|NCT02113956|143083039|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.38|2.53|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.53|0.38|
71791962|NCT02113956|143083040|SUPERIORITY||Odds Ratio (OR)|3.42|||||TWO_SIDED|95.0|1.65|7.09|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.09|1.65|
71791963|NCT02113956|143083041|SUPERIORITY||Incident Risk Ratio (IRR)|0.58|||||TWO_SIDED|95.0|0.22|1.5|||Poisson||||Adjusted for age and baseline number of condomless sex acts|1.5|0.22|
71791964|NCT02113956|143083042|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.6|2.09|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|2.09|0.6|
71791965|NCT02113956|143083043|SUPERIORITY||Incident Rate Ratio (IRR)|0.6|||||TWO_SIDED|95.0|0.22|1.68|||||||Adjusted for age and baseline number of condomless sex acts|1.68|0.22|
71892636|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.122|STANDARD_ERROR_OF_MEAN|0.146|||TWO_SIDED|95.0|0.837|1.505||||||Comparison at 72 h post first dose||1.505|0.837|
71892637|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.474|STANDARD_ERROR_OF_MEAN|0.164|||TWO_SIDED|95.0|1.063|2.045||||||Comparison at 96 h post first dose||2.045|1.063|
71892638|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.833|STANDARD_ERROR_OF_MEAN|0.107|||TWO_SIDED|95.0|0.672|1.031||||||Comparison at 6 h post first dose||1.031|0.672|
71892639|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.879|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.707|1.092||||||Comparison at 12 h post first dose||1.092|0.707|
71892640|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.023|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|0.8|1.307||||||Comparison at 18 h post first dose||1.307|0.800|
71892641|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.95|STANDARD_ERROR_OF_MEAN|0.111|||TWO_SIDED|95.0|0.761|1.187||||||Comparison at 24 h post first dose||1.187|0.761|
71677233|NCT03852628|142873077|SUPERIORITY||Odds Ratio (OR)|0.63||||0.52|TWO_SIDED|95.0|0.15|2.66|||Mixed Models Analysis|Modeled the probability of have both a reduction in PTSD and AUD||The Placebo arm served as the reference group.||2.66|0.15|0.52
71791966|NCT02113956|143083044|SUPERIORITY||Incident Rate Ratio (IRR)|1.1|||||TWO_SIDED|95.0|0.01|92.03|||||||Adjusted for age and baseline number of condomless sex acts|92.03|0.01|
71791967|NCT02113956|143083045|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.46|1.88|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|1.88|0.46|
71791968|NCT02113956|143083046|SUPERIORITY||Odds Ratio (OR)|3.4|||||TWO_SIDED|95.0|0.88|16.95|||Regression, Logistic||||Adjusted for age and baseline rate of abstinence|16.95|0.88|
71791969|NCT02113956|143083047|SUPERIORITY||Odds Ratio (OR)|3.39|||||TWO_SIDED|95.0|1.52|7.58|||Regression, Logistic||||Adjusted for age and baseline rate of HIV testing|7.58|1.52|
71791970|NCT01876485|143083055|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||0.003
71791971|NCT01876485|143083055|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.6|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."||||.60
71791972|NCT01876485|143083056|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||0.003
71791973|NCT01876485|143083056|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.003|TWO_SIDED||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.||||.003
71892642|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.968|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|0.743|1.262||||||Comparison at 48 h post first dose||1.262|0.743|
71892643|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.926|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|95.0|0.718|1.193||||||Comparison at 72 h post first dose||1.193|0.718|
71892644|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|1.229|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|95.0|0.936|1.613||||||Comparison at 96 h post first dose||1.613|0.936|
71892645|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.923|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|95.0|0.753|1.131||||||Comparison at 6 h post first dose||1.131|0.753|
71892646|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.768|STANDARD_ERROR_OF_MEAN|0.103|||TWO_SIDED|95.0|0.625|0.943||||||Comparison at 12 h post first dose||0.943|0.625|
71892647|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.826|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.655|1.042||||||Comparison at 18 h post first dose||1.042|0.655|
71677234|NCT00556933|142873086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||Chi-squared|||||||0.0004
71677235|NCT00556933|142873087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||General Linear Model|||||||0.45
71677236|NCT00556933|142873088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|TWO_SIDED||||||Fisher Exact|||||||0.53
71892648|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.761|STANDARD_ERROR_OF_MEAN|0.106|||TWO_SIDED|95.0|0.615|0.942||||||Comparison at 24 h post first dose||0.942|0.615|
71892649|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.781|STANDARD_ERROR_OF_MEAN|0.125|||TWO_SIDED|95.0|0.608|1.003||||||Comparison at 48 h post first dose||1.003|0.608|
71892650|NCT00996840|143306552|SUPERIORITY_OR_OTHER||Ratio (Treatment/Placebo)|0.668|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|0.524|0.851||||||Comparison at 72 h post first dose||0.851|0.524|
71892651|NCT00996840|143306552|OTHER||Ratio (Treatment/Placebo)|0.86|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.659|1.122||||||Comparison at 96 h post first dose||1.122|0.659|
71672270|NCT01262872|142862795|NON_INFERIORITY_OR_EQUIVALENCE|Vaccine efficacy (VE) estimated as \[(1-Relative Risk (i.e. investigational vaccine over control vaccine))\*100\] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|-3.5|||||TWO_SIDED|95.0|-29.3|17.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).||17.2|-29.3|
71672271|NCT00720213|142862911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|8.03||0.0054|TWO_SIDED|95.0|1.44|6.51|||Wilcoxon Signed Rank test|||Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.||6.51|1.44|0.0054
71672272|NCT00365794|142862938|OTHER|||||||0.77|||||||t-test, 2 sided|||Total body mass||||0.77
71672273|NCT00365794|142862938|OTHER|||||||0.003|||||||t-test, 2 sided|||Total fat mass||||0.003
71672274|NCT00365794|142862938|OTHER|||||||0.0007|||||||t-test, 2 sided|||Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.||||0.0007
71672275|NCT00365794|142862938|OTHER|||||||0.01|||||||t-test, 2 sided|||Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.||||0.01
71838534|NCT03976362|143185026|OTHER||Difference in Least Square Means|-2.81||||0.087|TWO_SIDED|95.0|-6.02|0.41||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||0.41|-6.02|0.0870
71838535|NCT03976362|143185027|OTHER||Hazard Ratio (HR)|1.6||||0.002|TWO_SIDED|95.0|1.18|2.16||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||2.16|1.18|0.0020
71838536|NCT00613106|143185028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4228||95.0|||||Cochran-Mantel-Haenszel|||||||0.4228
71672276|NCT00365794|142862939|OTHER|||||||0.12||||||No adjustment in p for multiple comparisons.|t-test, 2 sided|||||||0.12
71672277|NCT00365794|142862940|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
71672278|NCT00365794|142862941|OTHER|||||||0.0002||||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||0.0002
71672279|NCT00365794|142862942|OTHER|||||||0.04|||||||t-test, 2 sided|||Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.||||0.04
71672280|NCT00365794|142862942|OTHER|||||||0.59|||||||t-test, 2 sided|||Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.59
71672281|NCT00365794|142862942|OTHER|||||||0.03|||||||t-test, 2 sided|||Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks||||0.03
71672282|NCT00365794|142862943|OTHER|||||||0.0006|||||||t-test, 2 sided|||Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.||||0.0006
71672283|NCT00365794|142862944|OTHER|Test for fasting triglycerides||||||0.02|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.||||0.02
71672284|NCT00365794|142862944|OTHER|Test for total cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
71672285|NCT00365794|142862944|OTHER|Test for LDL cholesterol||||||0.02|||||||t-test, 2 sided|||nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||.02
71672286|NCT00365794|142862944|OTHER|Test for HDL cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel||||0.004
71672287|NCT00365794|142862945|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71672288|NCT00365794|142862946|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
71672289|NCT00365794|142862947|OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
71672290|NCT00745901|142862948|SUPERIORITY_OR_OTHER|||||||0.9698||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9698
71672291|NCT00745901|142862949|SUPERIORITY_OR_OTHER|||||||0.0715||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0715
71672292|NCT00745901|142862950|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0050
71672293|NCT00745901|142862951|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0006
71672294|NCT00745901|142862952|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0031
71672295|NCT00745901|142862953|SUPERIORITY_OR_OTHER|||||||0.0013||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0013
71672296|NCT00745901|142862954|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71672297|NCT00745901|142862955|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71672298|NCT00745901|142862956|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71672299|NCT00745901|142862957|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71672300|NCT00745901|142862958|SUPERIORITY_OR_OTHER|||||||0.0033||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0033
71672301|NCT00745901|142862959|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0060
71672302|NCT00745901|142862960|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71838537|NCT03953508|143185175|OTHER|Analysis of covariance test|||||>|0.05||||||Threshold for significance is p\<.05|ANCOVA|||||||>.05
71838538|NCT03953508|143185176|OTHER|T-test comparing differences, the null hypothesis is that the groups are equal|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
71791974|NCT02117999|143083064|NON_INFERIORITY|Sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D.|||||<|0.05|||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values. The relationship between the change in Kmax at 12 months and baseline parameters was assessed using Pearson's correlation analysis for either group.||||<0.05
71791975|NCT02117999|143083065|NON_INFERIORITY|sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D. The sample size of the study was 34 cases (allocation ratio of 2:1)|Mean Difference (Final Values)|35.0||||0.05|TWO_SIDED||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.||||0.05
71791976|NCT02496533|143083075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8|||<|0.001|TWO_SIDED|||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.001
71791977|NCT02496533|143083076|SUPERIORITY_OR_OTHER||||||<|0.02||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.02
71791978|NCT02496533|143083076|SUPERIORITY_OR_OTHER||||||<|0.09||||||No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.|ANOVA|||H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.09
71791979|NCT02496533|143083077|SUPERIORITY_OR_OTHER||||||<|0.009||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.009
71791980|NCT02496533|143083078|SUPERIORITY_OR_OTHER||||||<|0.45||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.||||<0.45
71791981|NCT03971695|143083094|OTHER||Adjusted geometric mean (gMean) ratio(%)|100.26|||||TWO_SIDED|90.0|90.18|111.48|||||Intra-individual geometric coefficient of variance (gCV) = 14.2. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||111.48|90.18|
71672303|NCT00745901|142862961|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71791982|NCT03971695|143083094|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.63|||||TWO_SIDED|90.0|85.37|98.35|||||Intra-individual geometric coefficient of variance (gCV) = 9.5. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||98.35|85.37|
71791983|NCT03971695|143083095|OTHER||Adjusted geometric mean (gMean) ratio(%)|98.01|||||TWO_SIDED|90.0|84.2|114.08|||||Intra-individual geometric coefficient of variance (gCV) = 20.5. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||114.08|84.20|
71791984|NCT03971695|143083095|OTHER||Adjusted geometric mean (gMean) ratio(%)|77.52|||||TWO_SIDED|90.0|68.11|88.22|||||Intra-individual geometric coefficient of variance (gCV) = 17.4. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||88.22|68.11|
71791985|NCT03971695|143083099|OTHER||Adjusted geometric mean (gMean) ratio(%)|96.42|||||TWO_SIDED|90.0|86.96|106.9|||||Intra-individual geometric coefficient of variance (gCV) = 13.9. Ratio is T1/R.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||106.90|86.96|
71791986|NCT03971695|143083099|OTHER||Adjusted geometric mean (gMean) ratio(%)|91.27|||||TWO_SIDED|90.0|85.4|97.54|||||Intra-individual geometric coefficient of variance (gCV) = 8.9. Ratio is T2/T1.|Analysis of variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects nested within sequences', 'period', and 'treatment'. Confidence intervals were calculated based on the residual error from the ANOVA.||97.54|85.40|
71838539|NCT03953508|143185177|OTHER|Analysis of variance test comparing average breakpoint for menthol and non-menthol smokers|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
71838540|NCT03953508|143185178|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
71838541|NCT03953508|143185179|OTHER|Analysis of variance|||||>|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||>.05
71838542|NCT03953508|143185180|OTHER|Analysis of variance|||||<|0.05||||||Threshold for significance is p\<.05|ANOVA|||||||<.05
71672304|NCT00745901|142862962|SUPERIORITY_OR_OTHER|||||||0.912||95.0|||||Fisher Exact|||||||0.912
71838543|NCT03953508|143185181|OTHER|T-test|||||<|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||<.05
71838544|NCT03953508|143185182|OTHER|Fisher's exact test|||||>|0.05||||||Threshold for significance is p\<.05|Fisher Exact|||||||>.05
71838545|NCT03953508|143185183|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
71672305|NCT00745901|142862963|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71672306|NCT00745901|142862964|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
71892652|NCT01485614|143306576|SUPERIORITY||Least Squares Means Difference|-0.19|||=|0.448|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin is compared against that of Placebo (pooled)."||||0.30|-0.68|= 0.448
71672307|NCT00745901|142862965|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Fisher Exact|||||||0.816
71672308|NCT00745901|142862966|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
71672309|NCT00745901|142862967|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71672310|NCT00758290|142862968|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71672311|NCT00884117|142862979|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Kruskal-Wallis|||||||<0.0001
71672312|NCT00884117|142862979|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
71791987|NCT04447417|143083100|OTHER||Point estimate|0.43|||<=|0.0001|TWO_SIDED|90.0|0.37|0.49||One-sided p-value. Threshold for significance at 0.05 level.|linear mixed model||Point estimate obtained was back-transformed by exponentiation|TEWL data for linear mixed model was log-transformed to account for right skewness of data and heteroskedasticity. The linear mixed effect on log (TEWL) included age, sex, number of STS, localization on the body, visit, number of STS-by-visit interaction and number of STS-by-age interaction as fixed effects. Model was run on data on lesional skin area.||0.49|0.37|<=0.0001
71791988|NCT02155738|143083134|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.||||<0.05
71791989|NCT02155738|143083135|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.||||<0.05
71791990|NCT02016625|143083137|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): ratio is outside of interval (80%, 125%) vs. alternative hypothesis (H1): ratio is inside of interval (80%, 125%)|gMean ratio (%)|108.2|STANDARD_ERROR_OF_MEAN|11.5||0.0033|TWO_SIDED|90.0|99.992|117.076|||ANOVA||ratio of cyclo + FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|Geometric mean (gMean) ratio of cyclo + FDV to cyclo treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||117.076|99.992|0.0033
71791991|NCT02016625|143083138|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|106.6|STANDARD_ERROR_OF_MEAN|11.7||0.0019|TWO_SIDED|90.0|98.36|115.534|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||115.534|98.360|0.0019
71791992|NCT02016625|143083139|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|90.14|STANDARD_ERROR_OF_MEAN|16.6||0.0457|TWO_SIDED|90.0|80.281|101.205|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||101.205|80.281|0.0457
71838546|NCT03953508|143185184|OTHER|T-test|||||>|0.05||||||Threshold for significance is p\<.05|t-test, 2 sided|||||||>.05
71838547|NCT04856163|143185185|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
71838548|NCT04856163|143185186|SUPERIORITY|||||||0.21|||||||discrete-time survival model|||||||0.21
71838549|NCT04856163|143185187|SUPERIORITY|||||||0.28|||||||Regression, Logistic|||||||0.28
71838550|NCT04856163|143185188|SUPERIORITY|||||||0.05|||||||Regression, Linear|||||||0.05
71672313|NCT00884117|142862979|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Pairwise Wilcoxon|||||||<0.01
71672314|NCT00884117|142862980|SUPERIORITY_OR_OTHER|||||||0.015|||||||Kruskal-Wallis|||||||0.015
71672315|NCT00884117|142862980|SUPERIORITY_OR_OTHER|||||||0.009|||||||Pairwise Wilcoxon|||||||0.009
71672316|NCT00884117|142862980|SUPERIORITY_OR_OTHER|||||||0.03|||||||Pairwise Wilcoxon|||||||0.03
71672317|NCT00884117|142862981|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Kruskal-Wallis|||||||0.0005
71672318|NCT00884117|142862981|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
71672319|NCT00884117|142862981|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
71672320|NCT00884117|142862982|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
71672321|NCT00884117|142862982|SUPERIORITY_OR_OTHER|||||||0.008|||||||Pairwise Wilcoxon|||||||0.008
71672322|NCT00884117|142862982|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Pairwise Wilcoxon|||||||<0.0001
71672323|NCT00884117|142862985|SUPERIORITY_OR_OTHER|||||||0.4464|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.4464
71672324|NCT00884117|142862986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||<0.0001
71672325|NCT00884117|142862987|SUPERIORITY_OR_OTHER|||||||0.2499|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible||||0.2499
71672326|NCT03859427|142862996|NON_INFERIORITY|The non-inferiority margin was 0.87 for the estimated ORR risk ratio.|Risk Ratio (RR)|0.954||||0.0666|TWO_SIDED|95.0|0.882|1.032||P-value (2.5% significance level) of the non-inferiority test via the synthesis approach (FDA, 2016) for non-inferiority comparison of ORR between treatment arms.|Synthesis approach||Risk ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.032|0.882|0.0666
71677237|NCT00556933|142873089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.463|TWO_SIDED||||||Fisher Exact|||||||0.463
71892653|NCT01485614|143306578|OTHER||Difference in Percentage|2.4|||||TWO_SIDED|95.0|-10.0|14.9||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||14.9|-10.0|
71892654|NCT01485614|143306580|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-1.3|10.8||"Percentage of participants with ≥1 adverse event for the arm Sitagliptin was compared against that of Placebo/Metformin with Miettinen \& Nurminen."||||||10.8|-1.3|
71892655|NCT01485614|143306583|SUPERIORITY||Difference in percentage|6.7|||=|0.374|TWO_SIDED|95.0|-8.1|21.2||"Percentage of participants with an A1C goal (7.0%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|Miettinen and Nurminen||||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the Linear Discriminant Analysis (LDA) model was used to impute whether the participant had met the goal.|21.2|-8.1|= 0.374
71672327|NCT03859427|142862998|OTHER||Odds Ratio (OR)|1.049|||||TWO_SIDED|95.0|0.653|1.683|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.683|0.653|
71677238|NCT00556933|142873090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Kaplan-Meier|||||||0.67
71791993|NCT02016625|143083140|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|140.98|STANDARD_ERROR_OF_MEAN|35.8||0.8122|TWO_SIDED|90.0|111.772|177.833|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||177.833|111.772|0.8122
71791994|NCT02016625|143083141|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|116.92|STANDARD_ERROR_OF_MEAN|11.0||0.065|TWO_SIDED|90.0|108.674|125.801|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||125.801|108.674|0.0650
71791995|NCT02016625|143083142|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|122.68|STANDARD_ERROR_OF_MEAN|23.9||0.4181|TWO_SIDED|90.0|104.8|143.6|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||143.60|104.80|0.4181
71791996|NCT02016625|143083143|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|127.41|STANDARD_ERROR_OF_MEAN|16.8||0.6207|TWO_SIDED|90.0|114.453|141.827|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||141.827|114.453|0.6207
71791997|NCT02016625|143083144|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|136.85|STANDARD_ERROR_OF_MEAN|22.4||0.8592|TWO_SIDED|90.0|118.683|157.793|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||157.793|118.683|0.8592
71791998|NCT02016625|143083145|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.15|STANDARD_ERROR_OF_MEAN|28.5||0.0269|TWO_SIDED|90.0|82.857|118.644|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||118.644|82.857|0.0269
71791999|NCT02016625|143083146|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|93.85|STANDARD_ERROR_OF_MEAN|25.1||0.0493|TWO_SIDED|90.0|80.059|110.022|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||110.022|80.059|0.0493
71892656|NCT01485614|143306585|SUPERIORITY||Difference in percentage|3.6|||=|0.639|TWO_SIDED|95.0|-11.6|18.3|||Miettinen and Nurminen|"The percentage of participants with an A1C at the A1C goal (6.5%) in the arm Sitagliptin was compared against the arm Placebo (pooled)."|||For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method based on the LDA model was used to impute whether the participant had met the goal.|18.3|-11.6|= 0.639
71892657|NCT01485614|143306590|SUPERIORITY||Least Squares Means Difference|1.5|||=|0.849|TWO_SIDED|95.0|-14.4|17.5|||Mixed Models Analysis|"The Least Squares (LS) Mean for the arm Sitagliptin was compared against that of Placebo (pooled)."||||17.5|-14.4|= 0.849
71792000|NCT02016625|143083147|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.54|STANDARD_ERROR_OF_MEAN|10.0||0|TWO_SIDED|90.0|93.375|106.115|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||106.115|93.375|0.0000
71792001|NCT02016625|143083148|NON_INFERIORITY_OR_EQUIVALENCE|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|96.16|STANDARD_ERROR_OF_MEAN|12.9||0.0008|TWO_SIDED|90.0|88.53|104.45|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.||104.45|88.53|0.0008
71792002|NCT01190254|143083149|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-4.8||||0.07|TWO_SIDED|95.0|-9.9|0.4||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-9.9|0.070
71792003|NCT01190254|143083149|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.6||||0.064|TWO_SIDED|95.0|-10.7|-0.5||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-10.7|0.064
71792004|NCT01190254|143083149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||||||p-value (adjusted to control Type I error in multiple testing) for Linear dose-response pattern (Placebo\<2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.064
71792005|NCT01190254|143083149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||||||p-value (adjusted to control Type I error in multiple testing) for Convex dose-response pattern (Placebo\<2.5 mg=5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.046
71792006|NCT01190254|143083149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||p-value (adjusted to control Type I error in multiple testing) for Concave dose-response pattern (Placebo=2.5 mg\<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)||||0.273
71792007|NCT01190254|143083150|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.218|TWO_SIDED|95.0|-0.5|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-0.5|0.218
71792008|NCT01190254|143083150|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.024||95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.0|-0.6|0.024
71672328|NCT03859427|142863004|OTHER||Odds Ratio (OR)|1.235|||||TWO_SIDED|95.0|0.775|1.97|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.970|0.775|
71792009|NCT01190254|143083151|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.6||||0.067|TWO_SIDED|95.0|-3.3|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-3.3|0.067
71892658|NCT00775021|143306667|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2334|STANDARD_ERROR_OF_MEAN|0.1618|||TWO_SIDED|95.0|-0.03501|0.2334|||Mixed Models Analysis||The mean difference is calculated as etafilconA minus nelfilcon A. Analysis is adjusted for lens type, period, lens type by period interaction, gender, lens type by gender interaction as fixed effects, subject nested within site as random effect.|The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.||0.2334|-0.03501|
71672329|NCT03859427|142863005|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.657|1.711|||||Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.|||1.711|0.657|
71672330|NCT03859427|142863006|OTHER||Least Squares (LS) Mean Difference|2.53|||||TWO_SIDED|95.0|0.38|4.69|||||Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.69|0.38|
71672331|NCT03859427|142863007|OTHER||LS Mean Difference|1.73|||||TWO_SIDED|95.0|-1.26|4.72|||||Analysis was based on ANCOVA model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.|||4.72|-1.26|
71672332|NCT03859427|142863008|OTHER||LS Mean difference|-0.26|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-2.54|2.03|||||Treatment difference at Cycle 5|||2.03|-2.54|
71792010|NCT01190254|143083151|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.012|TWO_SIDED|95.0|-3.8|-0.5|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.5|-3.8|0.012
71792011|NCT01190254|143083152|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.097|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.097
71792012|NCT01190254|143083152|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.099|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.099
71792013|NCT01190254|143083153|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.7||||0.062|TWO_SIDED|95.0|-5.6|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-5.6|0.062
71792014|NCT01190254|143083153|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-3.2||||0.025|TWO_SIDED|95.0|-6.0|-0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.4|-6.0|0.025
71792015|NCT01190254|143083154|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.1||||0.098|TWO_SIDED|95.0|-4.6|0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.4|-4.6|0.098
71792016|NCT01190254|143083154|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.3||||0.071|TWO_SIDED|95.0|-4.8|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-4.8|0.071
71792017|NCT01190254|143083155|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.4||||0.106|TWO_SIDED|95.0|-3.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-3.1|0.106
71792018|NCT01190254|143083155|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.9||||0.026|TWO_SIDED|95.0|-3.6|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-3.6|0.026
71792019|NCT01190254|143083156|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.2||||0.083|TWO_SIDED|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-2.6|0.083
71792020|NCT01190254|143083156|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.3||||0.067|TWO_SIDED|95.0|-2.7|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.7|0.067
71792021|NCT01190254|143083157|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.131|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.131
71792022|NCT01190254|143083157|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.135|TWO_SIDED|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-2.1|0.135
71792023|NCT01190254|143083158|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.0||||0.071|TWO_SIDED|95.0|-2.0|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.1|-2.0|0.071
71792024|NCT01190254|143083158|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.8||||0.12|TWO_SIDED|95.0|-1.9|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.9|0.120
71792025|NCT01190254|143083159|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.4||||0.263|TWO_SIDED|95.0|-1.2|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.3|-1.2|0.263
71672333|NCT03859427|142863008|OTHER||LS Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.24|2.28|||||Treatment difference at Cycle 12|||2.28|-3.24|
71677239|NCT00556933|142873091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.193|TWO_SIDED||||||Fisher Exact|||||||0.193
71672334|NCT03859427|142863008|OTHER||LS Mean difference|1.44|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-1.69|4.58|||||Treatment difference at safety follow-up|||4.58|-1.69|
71672335|NCT01804946|142863026|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0||||0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||0.05
71672336|NCT01804946|142863027|NON_INFERIORITY_OR_EQUIVALENCE|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed||||<0.05
71792026|NCT01190254|143083159|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.146|TWO_SIDED|95.0|-1.3|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.2|-1.3|0.146
71792027|NCT01190254|143083160|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.028|TWO_SIDED|95.0|1.1|3.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.6|1.1|0.028
71792028|NCT01190254|143083160|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.048|TWO_SIDED|95.0|1.0|3.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response|||3.3|1.0|0.048
71792029|NCT01190254|143083161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||||||p-value is for Log Rank test of difference in time to event (PANSS 30% response) curves between the three treatment groups|Log Rank|||||||0.576
71792030|NCT01190254|143083161|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.3||||0.171|TWO_SIDED|95.0|0.9|2.0|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||2.0|0.9|0.171
71792031|NCT01190254|143083161|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.368|TWO_SIDED|95.0|0.8|1.8|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo|||1.8|0.8|0.368
71792032|NCT01190254|143083162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.3||||0.094|TWO_SIDED|95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||0.0|-0.6|0.094
71792033|NCT01190254|143083162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.5||||0.003|TWO_SIDED|95.0|-0.8|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||-0.2|-0.8|0.003
71792034|NCT01190254|143083163|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.177|TWO_SIDED|95.0|0.8|2.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.8|0.8|0.177
71792035|NCT01190254|143083163|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.114|TWO_SIDED|95.0|0.9|2.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe \[Africa/Latin America sites assigned to this region\]) and treatment|OR was adjusted for region. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving CGI-I response|||2.9|0.9|0.114
71792036|NCT01190254|143083164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||p-value is for Log Rank test of difference in time to event (CGI-I response) curves between the three treatment groups|Log Rank|||||||0.057
71792037|NCT01190254|143083164|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.3|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.3|0.9|0.135
71792038|NCT01190254|143083164|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.8||||0.01|TWO_SIDED|95.0|1.2|2.9|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of \>1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo|||2.9|1.2|0.010
71672337|NCT01804946|142863028|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2 of Oseltamivir effect|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
71677240|NCT00556933|142873092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|TWO_SIDED||||||Fisher Exact|||||||0.422
71792039|NCT01190254|143083165|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.4||||0.417|TWO_SIDED|95.0|-2.0|4.8|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||4.8|-2.0|0.417
71792040|NCT01190254|143083165|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.2||||0.017|TWO_SIDED|95.0|0.8|7.6|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104)||7.6|0.8|0.017
71792041|NCT01190254|143083166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.6||||0.6|TWO_SIDED|95.0|-1.6|2.8|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||2.8|-1.6|0.600
71792042|NCT01190254|143083166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.1||||0.064|TWO_SIDED|95.0|-0.1|4.3|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||4.3|-0.1|0.064
71792043|NCT01190254|143083167|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.407|TWO_SIDED|95.0|-0.13|0.33|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.33|-0.13|0.407
71792044|NCT01190254|143083167|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.19||||0.111|TWO_SIDED|95.0|-0.04|0.42|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo|||0.42|-0.04|0.111
71792045|NCT04729127|143083170|OTHER|||||||0.79|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.79
71792046|NCT04729127|143083170|OTHER|||||||0.27|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.27
71672338|NCT01804946|142863029|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant margin was assumed to be 0.2°C|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.||PP set was analyzed||||<0.05
71838551|NCT03897465|143185238|NON_INFERIORITY|Pre-specified non-inferiority margin was 10%|Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-10.0||Upper Limit= +Infinity|||||Descriptive analysis of the primary endpoint was provided on per protocol population. The overall difference LomatuellPro (LP) - UrgoTul (UT) of the % of patients meeting main efficacy criterion was calculated with 95% bilateral confidence interval (CI). If lower limit of the 95% CI did not exceed the -10% value of pre-specified non-inferiority margin, non-inferiority had to be accepted. As a sensitivity analysis, the same analysis was performed on mITT (modified Intention-to-treat) population.|||-10|
71792047|NCT04729127|143083171|OTHER|||||||0.04|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.04
71792048|NCT04729127|143083171|OTHER|||||||0.02|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.02
71792049|NCT04729127|143083172|OTHER|||||||0.78|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.78
71677241|NCT00556933|142873093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.871|TWO_SIDED||||||Fisher Exact|||||||0.871
71792050|NCT04729127|143083172|OTHER|||||||0.89|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.89
71792051|NCT04729127|143083173|OTHER|||||||0.07|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.07
71792052|NCT04729127|143083173|OTHER|||||||0.88|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.88
71792053|NCT04729127|143083176|OTHER|||||||0.26|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.26
71792054|NCT04729127|143083176|OTHER|||||||0.74|||||||Regression, Linear|||See protocol for full statistical analysis plan.||||.74
71792055|NCT00887354|143083178|SUPERIORITY_OR_OTHER_LEGACY||LS Mean|0.04|||<|0.0001|TWO_SIDED|95.0|0.025|0.055|||Mixed Models Analysis|||||0.055|0.025|<.0001
71792056|NCT04608500|143083220|SUPERIORITY||Mean Difference (Final Values)|3.85|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|2.16|5.54|||ANCOVA|Analysis of covariance (ANCOVA) model includes treatment, Baseline inflammatory lesion count, and analysis center.||||5.54|2.16|<0.0001
71792057|NCT04608500|143083221|SUPERIORITY||Risk Ratio (RR)|1.263||||0.0077|TWO_SIDED|95.0|1.064|1.499||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||||1.499|1.064|0.0077
71792058|NCT04608500|143083222|SUPERIORITY||Risk Ratio (RR)|1.193||||0.0189|TWO_SIDED|95.0|1.024|1.39||The p-value is for the null hypothesis that the combined risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Test Stratified by Analysis Center||||1.390|1.024|0.0189
71792059|NCT04608500|143083223|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|2.672|<|0.0001|TWO_SIDED|95.0|6.05|16.54|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||||16.54|6.05|<0.0001
71792060|NCT04608500|143083224|SUPERIORITY||Mean Difference (Final Values)|4.38|STANDARD_ERROR_OF_MEAN|0.821|<|0.0001|TWO_SIDED|95.0|2.77|5.99|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 4||5.99|2.77|<0.0001
71792061|NCT04608500|143083224|SUPERIORITY||Mean Difference (Final Values)|5.07|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|3.52|6.63|||ANCOVA|ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.||Statistical Analysis For Week 8||6.63|3.52|<0.0001
71792062|NCT04608500|143083225|SUPERIORITY||Risk Ratio (RR)|1.715||||0.0114|TWO_SIDED|95.0|1.129|2.605||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 4||2.605|1.129|0.0114
71792063|NCT04608500|143083225|SUPERIORITY||Risk Ratio (RR)|1.319||||0.0061|TWO_SIDED|95.0|1.082|1.607||p-value is for the null hypothesis that the risk ratio equals 1.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by analysis center.||Statistical Analysis For Week 8||1.607|1.082|0.0061
71792064|NCT01010906|143083227|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.|Geometric Least-Square Mean Ratio|1.82|||||TWO_SIDED|90.0|0.96|3.43||||||||3.43|0.96|
71792065|NCT01010906|143083227|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.|Geometric Least-Square Mean Ratio|3.11|||||TWO_SIDED|90.0|1.6|6.04||||||||6.04|1.60|
71892659|NCT00775021|143306668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.07768|||TWO_SIDED|98.7|-0.108|0.06501|||Mixed Models Analysis||Mean difference calculated etafilcon A minus nelfilcon A. Analysis adjusted for lens type, period, lens by period interaction, gender, lens by gender interaction as fixed effects, subject nested within site and eye within subject as random effect.|The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.||0.06501|-0.1080|
71892660|NCT00775021|143306669|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.4001|STANDARD_ERROR_OF_MEAN|0.1799|||TWO_SIDED|98.7|-0.0055|0.4001|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.||0.4001|-0.0055|
71892661|NCT00775021|143306670|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|-0.1088|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|98.7|-0.5016|-0.1088|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.||-0.1088|-0.5016|
71792066|NCT01010906|143083227|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval falls within the interval \[0.50, 2.00\], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.|Geometric Least-Square Mean Ratio|8.42|||||TWO_SIDED|90.0|5.2|13.64||||||||13.64|5.20|
71792067|NCT01010906|143083228|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|1.57|||||TWO_SIDED|90.0|0.76|3.24||||||||3.24|0.76|
71792068|NCT01010906|143083228|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|2.21|||||TWO_SIDED|90.0|1.21|4.03||||||||4.03|1.21|
71892662|NCT00775021|143306671|NON_INFERIORITY_OR_EQUIVALENCE|Margin = -0.5|Mean Difference (Final Values)|0.2489|STANDARD_ERROR_OF_MEAN|0.168|||TWO_SIDED|98.7|-0.1301|0.2489|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.||0.2489|-0.1301|
71892663|NCT03431012|143306704|OTHER||||||>|0.05||||||Sidak corrections were used to adjust for multiple analyses.|ANCOVA|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean intentions differed between groups.||We predicted that Virus Agency (VA) and Positive Framing (PF) would lead to greater adherence intentions, compared to the human agency (HA) and negative framing (NF) versions respectively.||||>.05
71677242|NCT00556933|142873094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|TWO_SIDED||||||Kruskal-Wallis|||||||0.068
71792069|NCT01010906|143083228|SUPERIORITY_OR_OTHER||Geometric Least-Square Mean Ratio|6.16|||||TWO_SIDED|90.0|3.9|9.71||||||||9.71|3.90|
71792070|NCT00525174|143083231|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Regression, Logistic|||Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline \<= +4 letters for E-ETDRS testing).||||0.02
71792071|NCT00525174|143083232|NON_INFERIORITY_OR_EQUIVALENCE|The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|Mean Difference (Net)|0.38|||||ONE_SIDED|95.0||0.76|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.||0.76||
71792072|NCT00525174|143083232|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.09|TWO_SIDED|95.0|-0.06|0.83|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.||0.83|-0.06|0.09
71792073|NCT00525174|143083232|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity.||||0.20
71792074|NCT00525174|143083232|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||ANCOVA|||The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye.||||0.49
71892664|NCT03431012|143306705|OTHER||||||=|0.113||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher worry than the human agency assignment.||||=.113
71677243|NCT00556933|142873095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
71677244|NCT00556933|142873096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Fisher Exact|||||||0.21
71792075|NCT00525174|143083232|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|||The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model.||||0.21
71792076|NCT00525174|143083234|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.||||0.27
71792077|NCT00525174|143083235|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.||||0.86
71792078|NCT00525174|143083235|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Regression, Cox|||The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.||||0.28
71792079|NCT00525174|143083236|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.||||0.61
71792080|NCT00525174|143083239|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.90
71792081|NCT00525174|143083240|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.||||0.88
71792082|NCT00525174|143083242|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.||||0.07
71892665|NCT03431012|143306706|OTHER||||||=|0.809||||||Sidak corrections were used to adjust for multiple analyses|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the human agency assignment.||||=.809
71792083|NCT00525174|143083242|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Fisher Exact|||The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.||||0.21
71792084|NCT00525174|143083243|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.||||0.03
71672339|NCT01804946|142863030|NON_INFERIORITY_OR_EQUIVALENCE|The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.|Mean Difference (Final Values)|0.0|||<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
71792085|NCT00525174|143083244|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.||||<0.001
71792086|NCT00525174|143083245|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.||||0.90
71677245|NCT00556933|142873097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||Kruskal-Wallis|||||||0.40
71792087|NCT00525174|143083246|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.||||0.01
71792088|NCT00525174|143083247|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.||||0.12
71792089|NCT00525174|143083248|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.||||0.001
71792090|NCT00525174|143083249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.||||<0.001
71792091|NCT00525174|143083250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.||||<0.001
71792092|NCT00914810|143083251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.8|1.5|||t-test, 2 sided|||||1.5|-0.8|0.55
71792093|NCT00914810|143083252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.4|13.6|||t-test, 2 sided|||||13.6|7.4|<0.0001
71792094|NCT01327300|143083262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72||||0.001||95.0|||||t-test, 2 sided|||"The GIS scoring system is from 1-7 with one being a worse outcome and 7 the better outcome.~Comparisons below list the p values for comparison of difference in GIS between baseline and mesalamine."||||.001
71792095|NCT01327300|143083262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.008||95.0|||||t-test, 2 sided|||Comparisons of mean difference in GIS scores between baseline and placebo is made below.||||0.008
71792096|NCT01327300|143083263|SUPERIORITY_OR_OTHER|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||Correlation coefficients were used for each of three biomarkers in relation to other biomarkers and to the questionnaires and patient's symptoms.||||0.873
71792097|NCT01327300|143083263|SUPERIORITY_OR_OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|Pearson's linear coefficient||The study tested three biomarkers and symptom domains at baseline and the end of 12 weeks of placebo using the Mann-Whitney test, as well as correlations between domains with Pearson's linear correlation coefficient.||||0.810
71792098|NCT01327300|143083264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.5||||0.67|||||||t-test, 2 sided|Two-tailed P values are listed for baseline versus 12 weeks of mesalamine||"The FBDSI score is based on the severity of abdominal pian. Severity is rated as the following:~None= 0 points Mild= (1-36) Moderate =(37-110) Severe= (\>110 points)"||||0.67
71792099|NCT01327300|143083264|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0||||0.77|||||||t-test, 2 sided|||See prior description of the FBDSI score. Change in the FBDSI after 12 weeks of intervention is made using a two sided t-test.||||0.77
71792100|NCT01327300|143083265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0||||0.61|||||||t-test, 2 sided|||For the IBS QOL we compared the change in IBS-Quality of Life (IBS-QOL) after 12 weeks of mesalamine.||||0.61
71792101|NCT01327300|143083265|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2||||0.33|||||||t-test, 2 sided|||Comparison of change in IBS-Quality of Life (IBS-QOL)from baseline after 12 weeks of intervention was made.||||0.33
71672340|NCT01804946|142863031|NON_INFERIORITY_OR_EQUIVALENCE|To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed||||<0.05
71672341|NCT01804946|142863032|NON_INFERIORITY_OR_EQUIVALENCE|To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
71672342|NCT01804946|142863033|NON_INFERIORITY_OR_EQUIVALENCE|To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|18.2|<|0.05|ONE_SIDED|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed||||<0.05
71672343|NCT01804946|142863034|NON_INFERIORITY_OR_EQUIVALENCE|The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir|Risk Difference (RD)|0.0|||<|0.05|ONE_SIDED|95.0|||||The Wald method of Z statistics calcul|The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions||PP set was analyzed||||<0.05
71792102|NCT01327300|143083266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.71||95.0|||||t-test, 2 sided|||Comparison of the change in HADS score of baseline to 12 weeks of mesalamine is made.||||0.71
71792103|NCT01327300|143083266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.57||95.0|||||t-test, 2 sided|||Comparison of change in HADS score between baseline and after 12 weeks of placebo is made.||||0.57
71792104|NCT01327300|143083267|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||Comparison of the lactulose/mannitol ratio is made after a 12 week intervention with mesalamine to 12 weeks of placebo.||||0.55
71792105|NCT02807350|143083272|OTHER||Risk Difference (RD)|19.0|||||TWO_SIDED|95.0|7.0|29.0||||||\>1 point analysis||29|7|
71792106|NCT02807350|143083272|OTHER|\>2 points analysis|Risk Difference (RD)|20.0|||||TWO_SIDED|95.0|10.0|28.0||||||||28|10|
71672344|NCT00722137|142863035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.79|||Log Rank|Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.79|0.50|<0.001
71792107|NCT02807350|143083273|OTHER|\>1 analysis|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-7.0|15.0||||||||15|-7|
71838552|NCT05119023|143185243|OTHER|||||||0.39||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language Severity and Characterization of learning: SRT Observational Learning Scores||||0.39
71838553|NCT05119023|143185243|OTHER||||||<|0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Observational Learning Scores||||<0.01
71672345|NCT00722137|142863036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.74|0.45|<0.001
71672346|NCT00722137|142863038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||0.65|0.38|<0.001
71672347|NCT00722137|142863039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||=|0.001|TWO_SIDED|95.0|0.38|0.65|||Log Rank|||||0.65|0.38|=0.001
71792108|NCT02807350|143083273|OTHER|\>2 analysis|Risk Difference (RD)|8.0|||||TWO_SIDED|95.0|-2.0|17.0||||||||17|-2|
71792109|NCT03739112|143083293|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for relative vaccine efficacy (VE) was \> -20%.|percent VE|8.8|||||TWO_SIDED|95.0|-16.7|28.7|||||VE of VLP vaccine versus Fluarix = (1-ARVv/ARVc) x 100% where ARVv = attack rate in participants vaccinated with the Quadrivalent VLP Influenza vaccine and ARVc = attack rate in participants vaccinated with an active Fluarix.|||28.7|-16.7|
71792110|NCT02529137|143083362|NON_INFERIORITY|the non-inferiority margin was set at 4%|difference|0.4|||||TWO_SIDED|95.0|-0.3|1.01||||||||1.01|-0.30|
71792111|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-28.18|||<|0.0001|TWO_SIDED|95.0|-33.85|-22.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-22.51|-33.85|<0.0001
71792112|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-25.29|||<|0.0001|TWO_SIDED|95.0|-31.23|-19.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||-19.34|-31.23|<0.0001
71792113|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-29.15|||<|0.0001|TWO_SIDED|95.0|-33.15|-25.15|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-25.15|-33.15|<0.0001
71838554|NCT05119023|143185243|OTHER|||||||0.95||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Language severity and Characterization of learning: AGL Rule-based Learning Scores||||0.95
71838555|NCT05119023|143185244|OTHER|Sample underpowered for regression so correlation examined||||||0.36||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: SRT Observational Learning Scores||||0.36
71838556|NCT05119023|143185244|OTHER|||||||0.09|||||||Pearson's correlation|The threshold for statistical significance was p = 0.05||Examination of Attention and Characterization of learning: AGL Observational Learning Scores||||0.09
71838557|NCT05119023|143185244|OTHER|||||||0.32||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Attention and Characterization of learning: AGL Rule Based Learning||||0.32
71792114|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-22.25|||<|0.0001|TWO_SIDED|95.0|-26.36|-18.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||-18.14|-26.36|<0.0001
71792115|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-17.52|||<|0.0001|TWO_SIDED|95.0|-21.54|-13.5|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-13.50|-21.54|<0.0001
71672348|NCT00722137|142863040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.428||||0.275|TWO_SIDED|95.0|0.749|2.722|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.722|0.749|0.275
71672349|NCT00722137|142863041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.688|||<|0.007|TWO_SIDED|95.0|1.148|2.481|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) \> 1 indicates an advantage for VcR-CAP.|||2.481|1.148|<0.007
71672350|NCT00722137|142863042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.173|TWO_SIDED|95.0|0.59|1.1|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.|||1.10|0.59|0.173
71677246|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9788||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Computer Usage||||0.9788
71677247|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.6571||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Reading||||0.6571
71792116|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-15.51|||<|0.0001|TWO_SIDED|95.0|-19.53|-11.49|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||-11.49|-19.53|<0.0001
71792117|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-9.74|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||-5.51|-13.97|<0.0001
71838558|NCT05119023|143185245|OTHER|Sample underpowered for regression so correlation examined||||||0.64||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: SRT Observational Learning Scores||||0.64
71838559|NCT05119023|143185245|OTHER|||||||0.01||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Observational Learning Scores||||0.01
71838560|NCT05119023|143185245|OTHER|||||||0.79|||||||Pearson's correlation|||Examination of Working Memory and Characterization of learning: AGL Rule-based Learning Scores||||0.79
71838561|NCT05119023|143185246|OTHER|Sample underpowered for regression so correlation examined||||||0.9||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: SRT Observational Learning Scores||||0.90
71838562|NCT05119023|143185246|OTHER|||||||0.09||||||The threshold for statistical significance was p = 0.05|Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Observational Learning Scores||||0.09
71838563|NCT05119023|143185246|OTHER|||||||0.24|||||||Pearson's correlation|||Examination of Executive Function and Characterization of learning: AGL Rule-based Learning Scores||||0.24
71838564|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838565|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838566|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838567|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838568|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838569|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838570|NCT00875277|143185269|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71838571|NCT00875277|143185269|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
71838572|NCT00875277|143185269|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||||||0.009
71838573|NCT00875277|143185269|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71838574|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838575|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838576|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838577|NCT00875277|143185269|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71838578|NCT00875277|143185269|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
71838579|NCT04292223|143185299|OTHER|Comparison of the 16-week value with the baseline value|Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|8.8|19.3|||Mixed Models Analysis|||||19.3|8.8|<0.0001
71838580|NCT00753545|143185312|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.49|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.49|0.25|<0.00001
71838581|NCT00753545|143185313|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.02|TWO_SIDED|95.0|0.55|0.95|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.95|0.55|0.02
71838582|NCT00753545|143185317|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-27.1||||0.03185|TWO_SIDED|95.0|-51.9|-2.4|||ANCOVA|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||LS mean \< 0 favours olaparib||-2.4|-51.9|0.03185
71838583|NCT00753545|143185321|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.35|||<|1e-05|TWO_SIDED|95.0|0.25|0.47|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||0.47|0.25|<0.00001
71792118|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-4.98||||0.0221|TWO_SIDED|95.0|-9.19|-0.76|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||-0.76|-9.19|0.0221
71792119|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-35.38|||<|0.0001|TWO_SIDED|95.0|-38.89|-31.87|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-31.87|-38.89|<0.0001
71792120|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-27.08|||<|0.0001|TWO_SIDED|95.0|-30.6|-23.57|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-23.57|-30.60|<0.0001
71792121|NCT02246673|143083394|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|-31.26|||<|0.0001|TWO_SIDED|95.0|-34.77|-27.75|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||-27.75|-34.77|<0.0001
71792122|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.27||||0.0002|TWO_SIDED|95.0|12.57|35.98|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||35.98|12.57|0.0002
71792123|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.08||||0.0013|TWO_SIDED|95.0|8.38|31.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||31.79|8.38|0.0013
71792124|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|23.7|||<|0.0001|TWO_SIDED|95.0|14.23|33.17|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||33.17|14.23|<0.0001
71792125|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.37||||0.0008|TWO_SIDED|95.0|8.3|28.44|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||28.44|8.30|0.0008
71792126|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|18.82||||0.0101|TWO_SIDED|95.0|4.86|32.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||32.79|4.86|0.0101
71792127|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|20.52||||0.0055|TWO_SIDED|95.0|6.56|34.48|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||34.48|6.56|0.0055
71792128|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|10.36||||0.0065|TWO_SIDED|95.0|3.13|17.59|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||17.59|3.13|0.0065
71792129|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|1.79||||0.614|TWO_SIDED|95.0|-5.37|8.94|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4||8.94|-5.37|0.6140
71792130|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|30.83||||0.0002|TWO_SIDED|95.0|15.62|46.04|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||46.04|15.62|0.0002
71792131|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|24.38||||0.0019|TWO_SIDED|95.0|9.63|39.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||39.14|9.63|0.0019
71838584|NCT00753545|143185325|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.22|TWO_SIDED|95.0|0.88|1.71|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.71|0.88|0.22
71792132|NCT02246673|143083395|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|26.35||||0.0009|TWO_SIDED|95.0|11.59|41.11|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||41.11|11.59|0.0009
71838585|NCT00753545|143185326|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.75|1.56|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.56|0.75|0.67
71677248|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.471||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Leisure Activities||||0.4710
71792133|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|139.11|||<|0.0001|TWO_SIDED|95.0|93.92|184.31|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||184.31|93.92|<0.0001
71792134|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|174.47|||<|0.0001|TWO_SIDED|95.0|125.52|233.42|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||233.42|125.52|<0.0001
71792135|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|168.03|||<|0.0001|TWO_SIDED|95.0|123.13|212.93|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||212.93|123.13|<0.0001
71792136|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.75|||<|0.0001|TWO_SIDED|95.0|138.04|239.46|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||239.46|138.04|<0.0001
71792137|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|70.43||||0.0005|TWO_SIDED|95.0|33.74|107.12|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||107.12|33.74|0.0005
71792138|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|91.5|||<|0.0001|TWO_SIDED|95.0|54.81|128.19|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||128.19|54.81|<0.0001
71838586|NCT00753545|143185327|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.38|TWO_SIDED|95.0|0.83|1.64|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR \< 1 favours olaparib||1.64|0.83|0.38
71838587|NCT03839940|143185407|SUPERIORITY||||||<|0.9999|||||||Fisher Exact|||||||< 0.9999
71838588|NCT03839940|143185408|SUPERIORITY|||||||0.3346|||||||Wilcoxon (Mann-Whitney)|||||||0.3346
71792139|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|40.11|||<|0.0001|TWO_SIDED|95.0|25.17|55.05|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||55.05|25.17|<0.0001
71792140|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|15.96||||0.035|TWO_SIDED|95.0|1.2|30.71|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||30.71|1.20|0.0350
71792141|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|236.08|||<|0.0001|TWO_SIDED|95.0|178.29|293.86|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||293.86|178.29|<0.0001
71792142|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|146.2|||<|0.0001|TWO_SIDED|95.0|90.4|202.01|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||202.01|90.40|<0.0001
71792143|NCT02246673|143083396|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|176.57|||<|0.0001|TWO_SIDED|95.0|120.77|232.38|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||232.38|120.77|<0.0001
71792144|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|135.82|||<|0.0001|TWO_SIDED|95.0|93.33|178.32|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||178.32|93.33|<0.0001
71792145|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|178.58|||<|0.0001|TWO_SIDED|95.0|129.25|227.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1||227.90|129.25|<0.0001
71792146|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|163.98|||<|0.0001|TWO_SIDED|95.0|120.8|207.16|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||207.16|120.80|<0.0001
71677249|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.736||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Social Activities||||0.7360
71792147|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|169.93|||<|0.0001|TWO_SIDED|95.0|122.82|217.03|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2||217.03|122.82|<0.0001
71792148|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|59.6||||0.0007|TWO_SIDED|95.0|28.85|90.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||90.34|28.85|0.0007
71792149|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|73.54|||<|0.0001|TWO_SIDED|95.0|42.79|104.28|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3||104.28|42.79|<0.0001
71792150|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|33.7|||<|0.0001|TWO_SIDED|95.0|21.21|46.2|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||46.20|21.21|<0.0001
71792151|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|27.08||||0.0001|TWO_SIDED|95.0|14.58|39.58|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4||39.58|14.58|0.0001
71792152|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|188.83|||<|0.0001|TWO_SIDED|95.0|152.55|225.1|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||225.10|152.55|<0.0001
71792153|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|116.83|||<|0.0001|TWO_SIDED|95.0|81.76|151.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||151.90|81.76|<0.0001
71792154|NCT02246673|143083397|SUPERIORITY_OR_OTHER||Geometric Least Squares mean Ratio|151.66|||<|0.0001|TWO_SIDED|95.0|116.59|186.73|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5||186.73|116.59|<0.0001
71677250|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4999||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Driving||||0.4999
71792155|NCT00189228|143083434|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01||95.0|||||t-test, 2 sided|||This is not a drug study.||||<0.01
71792156|NCT01831154|143083461|SUPERIORITY_OR_OTHER|||||||0.512|||||||Chi-squared|Chi-squared value of 1.34 and Cramer's V .190||Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.||||0.512
71792157|NCT01831154|143083462|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|||||||0.024
71792158|NCT01831154|143083464|SUPERIORITY_OR_OTHER|||||||0.132|||||||ANOVA|||||||0.132
71792159|NCT01831154|143083465|SUPERIORITY_OR_OTHER|||||||0.908||||||A one way ANOVA was used to determine if participants in the tight glycemic group had shorter intensive care unit (ICU) length of stay (LOS) than participants in the other interventional groups.|ANOVA|||||||0.908
71792160|NCT00651755|143083527|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.2|||||TWO_SIDED|90.0|1.08|1.33|||90% CI||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,CP, between Aprepitant treatment to control Group.|||1.33|1.08|
71792161|NCT00651755|143083528|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|ratio Geometric mean AUC|0.75|STANDARD_DEVIATION|0.29|||TWO_SIDED|95.0|0.65|0.86|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group|||0.86|0.65|
71838589|NCT03839940|143185424|SUPERIORITY||||||<|0.70361|||||||Fisher Exact|||Female Population.||||< 0.70361
71838590|NCT03839940|143185424|SUPERIORITY||||||<|0.4667|||||||Fisher Exact|||Male population.||||<0.4667
71792162|NCT00651755|143083529|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|0.97|STANDARD_DEVIATION|0.35|||TWO_SIDED|90.0|0.83|1.13|||equivalence analysis|The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment to the control group|Ratio Geometric Mean AUC of Analyte, 4-OHCP, between Aprepitant treatment to control Group|||1.13|0.83|
71792163|NCT00651755|143083530|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.04|STANDARD_DEVIATION|0.68|||TWO_SIDED|90.0|0.82|1.33|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte, VC, Between Aprepitant treatment to control Group.|||1.33|0.82|
71792164|NCT00651755|143083531|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.08|STANDARD_DEVIATION|0.17||||90.0|1.02|1.15|||equivalence analysis||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group.|||1.15|1.02|
71792165|NCT00651755|143083532|NON_INFERIORITY_OR_EQUIVALENCE|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.16|STANDARD_DEVIATION|0.47|||TWO_SIDED|90.0|1.01|1.32|||equivalence analysis||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,PL, Between Aprepitant treatment to control Group.|||1.32|1.01|
71792166|NCT00624052|143083533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||||95.0|0.47|1.66|||Cochran-Mantel-Haenszel|||||1.66|0.47|
71792167|NCT00624052|143083533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||||95.0|0.14|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.14|
71792168|NCT00624052|143083533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||||95.0|0.12|0.48|||Cochran-Mantel-Haenszel|||||0.48|0.12|
71792169|NCT00624052|143083533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||||95.0|0.17|0.59|||Cochran-Mantel-Haenszel|||||0.59|0.17|
71792170|NCT00624052|143083533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||||95.0|0.15|0.49|||Cochran-Mantel-Haenszel|||||0.49|0.15|
71792171|NCT00624052|143083533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||||95.0|0.42|1.68|||Cochran-Mantel-Haenszel|||||1.68|0.42|
71792172|NCT02404285|143083547|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71792173|NCT02404285|143083549|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71792174|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the geometric mean ratio (GMR) for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 1: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
71792175|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.78|0.93||||||Serotype 3: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.78|
71792176|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.71|0.93||||||Serotype 4: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.93|0.71|
71792177|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.74|0.94||||||Serotype 5: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.94|0.74|
71792178|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.66|0.88||||||Serotype 6A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.88|0.66|
71792179|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.73|0.95||||||Serotype 6B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.95|0.73|
71792180|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.86|||||TWO_SIDED|95.0|0.77|0.96||||||Serotype 7F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.96|0.77|
71792181|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.93|||||TWO_SIDED|95.0|0.82|1.05||||||Serotype 9V: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.05|0.82|
71838591|NCT03839940|143185425|SUPERIORITY||||||<|1|||||||Fisher Exact|||Black or African American population||||<1.0
71838592|NCT03839940|143185425|SUPERIORITY||||||<|1|||||||Fisher Exact|||White population||||<1.0
71838593|NCT03839940|143185426|SUPERIORITY||||||<|1|||||||Fisher Exact|||Not Hispanic or Latino population.||||<1.0
71838594|NCT03839940|143185427|SUPERIORITY||||||<|0.1701|||||||Wilcoxon (Mann-Whitney)|||Female population.||||<0.1701
71838595|NCT03839940|143185427|SUPERIORITY||||||<|0.4811|||||||Wilcoxon (Mann-Whitney)|||Male population.||||<0.4811
71838596|NCT03839940|143185428|SUPERIORITY||||||<|1|||||||Wilcoxon (Mann-Whitney)|||Black or African American Population||||<1.0
71838597|NCT03839940|143185428|SUPERIORITY||||||<|0.5029|||||||Wilcoxon (Mann-Whitney)|||White Population||||<0.5029
71838598|NCT03839940|143185429|SUPERIORITY||||||<|0.295|||||||Wilcoxon (Mann-Whitney)|||Not Hispanic or Latino Population||||<0.2950
71838599|NCT05210608|143185491|SUPERIORITY||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.29|TWO_SIDED|95.0|-0.85|2.18||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the post-treatment assessment.||2.18|-.85|.29
71792182|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.89|1.13||||||Serotype 14: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.13|0.89|
71792183|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.74|0.97||||||Serotype 18C: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.74|
71792184|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.71|0.9||||||Serotype 19A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.90|0.71|
71792185|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.7|0.91||||||Serotype 19F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.91|0.70|
71792186|NCT03760146|143083619|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.7|0.97||||||Serotype 23F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.97|0.70|
71792187|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.55|||||TWO_SIDED|95.0|0.49|0.62||||||Serotype 8: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||0.62|0.49|
71677251|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1159||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Outdoor Activities||||0.1159
71792188|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.86|||||TWO_SIDED|95.0|1.63|2.12||||||Serotype 10A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.12|1.63|
71792189|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.75|||||TWO_SIDED|95.0|1.52|2.01||||||Serotype 11A: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.01|1.52|
71792190|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.27|1.72||||||Serotype 12F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.72|1.27|
71792191|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.12|||||TWO_SIDED|95.0|2.62|3.71||||||Serotype 15B: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||3.71|2.62|
71792192|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.99|||||TWO_SIDED|95.0|1.7|2.32||||||Serotype 22F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||2.32|1.70|
71792193|NCT03760146|143083620|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.38|||||TWO_SIDED|95.0|1.21|1.57||||||Serotype 33F: Geometric mean ratio (20vPnC/Saline vs 13vPnC/PPSV23) and the 2-sided 95% CI||1.57|1.21|
71792194|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26||||||Serotype 1: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.84|
71792195|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.92|1.22||||||Serotype 3: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.92|
71892666|NCT03431012|143306707|OTHER|||||||0.025||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the human agency assignment.||||0.025
71792196|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.87|1.38||||||Serotype 4: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.38|0.87|
71677252|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4567||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Frequency of Outdoor Activities||||0.4567
71792197|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||Serotype 5: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.72|
71792198|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.21|||||TWO_SIDED|95.0|0.95|1.53||||||Serotype 6A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.53|0.95|
71892667|NCT03431012|143306708|OTHER||||||=|0.199||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that the Agency Assignment would not affect self-efficacy, i.e. people's perceived ability to use the antivirals as recommended.||||=0.199
71792199|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.0|1.56||||||Serotype 6B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|1.00|
71792200|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.89|||||TWO_SIDED|95.0|0.74|1.07||||||Serotype 7F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.07|0.74|
71792201|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.83|1.26||||||Serotype 9V: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.26|0.83|
71792202|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.25|||||TWO_SIDED|95.0|1.01|1.54||||||Serotype 14: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.54|1.01|
71792203|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.33|||||TWO_SIDED|95.0|1.06|1.68||||||Serotype 18C: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.06|
71792204|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||Serotype 19A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.25|0.85|
71792205|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 19F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.22|0.80|
71792206|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.68|||||TWO_SIDED|95.0|1.27|2.22||||||Serotype 23F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.22|1.27|
71792207|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.78|1.2||||||Serotype 8: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.20|0.78|
71792208|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||Serotype 10A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.28|0.84|
71792209|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.22|||||TWO_SIDED|95.0|0.96|1.56||||||Serotype 11A: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.96|
71792210|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.88|1.39||||||Serotype 12F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.39|0.88|
71792211|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.17|||||TWO_SIDED|95.0|0.88|1.56||||||Serotype 15B: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.56|0.88|
71792212|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||Serotype 22F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.17|0.69|
71838600|NCT05210608|143185491|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.45||0.48|TWO_SIDED|95.0|-3.45|5.79||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||We analyzed whether significant changes occurred between baseline and the 1 month follow up||5.79|-3.45|.48
71838601|NCT05210608|143185492|SUPERIORITY||Mean Difference (Final Values)|37.7|STANDARD_ERROR_OF_MEAN|14.8|=|0.015|TWO_SIDED|95.0|19.9|102.1||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to Post-treatment.||102.10|19.90|=0.015
71838602|NCT05210608|143185492|SUPERIORITY||Mean Difference (Final Values)|17.03|STANDARD_ERROR_OF_MEAN|24.69||0.08|TWO_SIDED|95.0|-14.57|142.57|||t-test, 2 sided|||We analyzed whether there were significant differences in number of total cigarettes smoked per week from baseline to 1 month follow-up.||142.57|-14.57|.08
71838603|NCT05210608|143185493|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|3.64||0.9|TWO_SIDED|95.0|-9.86|8.86|||t-test, 2 sided|||We analyzed whether there were significant differences in carbon monoxide ppm from baseline to Post-treatment.||8.86|-9.86|.90
71838604|NCT05210608|143185493|SUPERIORITY||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|11.29||0.32|TWO_SIDED|95.0|-49.42|22.42|||t-test, 2 sided|||We analyzed whether there were significant difference in carbon monoxide ppm from baseline to the 1 month follow-up.||22.42|-49.42|.32
71838605|NCT05210608|143185494|SUPERIORITY||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|4.36||0.18|TWO_SIDED|95.0|-5.1|19.1|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to post-treatment.||19.10|-5.10|.18
71838606|NCT05210608|143185494|SUPERIORITY||Mean Difference (Final Values)|-12.64|STANDARD_ERROR_OF_MEAN|5.14||0.18|TWO_SIDED|95.0|-25.38|7.38|||t-test, 2 sided|||We analyzed whether there were significant differences in working memory scores from baseline to the 1 month follow up.||7.38|-25.38|.18
71838607|NCT05851573|143185495|OTHER||||||<|0.05|||||||t-test, 2 sided|df = 9||||||< .05
71838608|NCT05851573|143185496|OTHER||||||=|0.775|||||||t-test, 2 sided|df = 9||||||= .775
71792213|NCT03760146|143083621|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.81|1.3||||||Serotype 33F: GMR (20vPnC Cohort 2 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.30|0.81|
71792214|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.23|||||TWO_SIDED|95.0|1.01|1.5||||||Serotype 1: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.50|1.01|
71792215|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.87|1.16||||||Serotype 3: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.16|0.87|
71792216|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.31|||||TWO_SIDED|95.0|2.65|4.13||||||Serotype 4: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.13|2.65|
71792217|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||Serotype 5: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.36|0.91|
71792218|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.84|||||TWO_SIDED|95.0|3.06|4.83||||||Serotype 6A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.83|3.06|
71792219|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.41|||||TWO_SIDED|95.0|2.73|4.26||||||Serotype 6B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.26|2.73|
71677253|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3439||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Time Spent to Take Care of Eyes||||0.3439
71792220|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.58|||||TWO_SIDED|95.0|1.3|1.91||||||Serotype 7F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.91|1.30|
71792221|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.5|||||TWO_SIDED|95.0|2.83|4.33||||||Serotype 9V: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.33|2.83|
71792222|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.39|||||TWO_SIDED|95.0|1.93|2.96||||||Serotype 14: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.96|1.93|
71792223|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|3.2|||||TWO_SIDED|95.0|2.53|4.04||||||Serotype 18C: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||4.04|2.53|
71792224|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.31|||||TWO_SIDED|95.0|1.91|2.81||||||Serotype 19A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.81|1.91|
71838609|NCT05851573|143185497|OTHER||||||=|0.444|||||||t-test, 2 sided|df = 10||||||= .444
71838610|NCT05851573|143185498|OTHER|||||||0.959|||||||t-test, 2 sided|df = 9||||||.959
71838611|NCT05851573|143185499|OTHER|||||||0.068|||||||t-test, 2 sided|df = 9||||||.068
71838612|NCT05851573|143185500|OTHER||||||=|0.119|||||||t-test, 2 sided|df = 10||||||= .119
71838613|NCT05851573|143185501|OTHER||||||=|0.258|||||||t-test, 2 sided|df = 10||||||= .258
71838614|NCT05851573|143185502|OTHER||||||=|0.593|||||||t-test, 2 sided|df = 10||||||= .593
71838615|NCT04473222|143185546|SUPERIORITY||Odds Ratio, log|-0.15||||0.026|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||.026
71838616|NCT04473222|143185547|SUPERIORITY||Odds Ratio, log|-0.2||||0.032|TWO_SIDED||||||t-test, 2 sided||The logit represents the difference in log odds per 1-week change in time for the intervention group relative to enhanced usual care.|||||0.032
71838617|NCT04473222|143185548|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.01|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||.010
71838618|NCT04473222|143185549|SUPERIORITY||Slope|0.009|STANDARD_ERROR_OF_MEAN|0.009||0.161|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.161
71677254|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3331||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered With Amount of Time Taking Care of Eyes||||0.3331
71792225|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|2.17|||||TWO_SIDED|95.0|1.76|2.68||||||Serotype 19F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.68|1.76|
71792226|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|4.8|||||TWO_SIDED|95.0|3.65|6.32||||||Serotype 23F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||6.32|3.65|
71792227|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.71|||||TWO_SIDED|95.0|1.38|2.12||||||Serotype 8: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.12|1.38|
71792228|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.62|||||TWO_SIDED|95.0|1.31|2.0||||||Serotype 10A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.00|1.31|
71792229|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.04|1.68||||||Serotype 11A: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.68|1.04|
71792230|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.91|||||TWO_SIDED|95.0|1.51|2.41||||||Serotype 12F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.41|1.51|
71792231|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.52|||||TWO_SIDED|95.0|1.13|2.05||||||Serotype 15B: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.05|1.13|
71792232|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.69|||||TWO_SIDED|95.0|1.3|2.2||||||Serotype 22F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||2.20|1.30|
71792233|NCT03760146|143083622|NON_INFERIORITY|Noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).|Ratio of GMTs|1.4|||||TWO_SIDED|95.0|1.1|1.79||||||Serotype 33F: GMR (20vPnC Cohort 3 vs 20vPnC Cohort 1 60-64 years of age) and the 2-sided 95% CI||1.79|1.10|
71838619|NCT04473222|143185550|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.01||0.006|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.006
71792234|NCT00449644|143083632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.77||||0.0034|TWO_SIDED|95.0|2.26|61.23|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||61.23|2.26|0.0034
71792235|NCT00449644|143083633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.57|3.8|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||3.80|1.57|<0.0001
71792236|NCT00449644|143083634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.14||||0.0022|TWO_SIDED|95.0|1.51|6.53|||Cox-proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||||6.53|1.51|0.0022
71792237|NCT00449644|143083635|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.029|TWO_SIDED|95.0|1.05|2.59|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||MGIT negative (Responders)||2.59|1.05|0.0290
71838620|NCT04473222|143185551|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.045|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.045
71838621|NCT04473222|143185552|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.685|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.685
71792238|NCT00449644|143083636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|38.9|STANDARD_ERROR_OF_MEAN|12.38||0.003|TWO_SIDED|95.0|13.97|63.88|||Regression, Logistic|Treatment as covariate||Week 8||63.88|13.97|0.003
71792239|NCT00449644|143083636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.7|STANDARD_ERROR_OF_MEAN|13.12||0.237|TWO_SIDED|95.0|-10.7|42.17|||Regression, Logistic|Treatment as covariate||Week 24||42.17|-10.70|0.237
71792240|NCT00449644|143083636|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.9|STANDARD_ERROR_OF_MEAN|15.02||0.5564|TWO_SIDED|95.0|-21.37|39.18|||Regression, Logistic|Treatment as covariate||Week 104 (Stage 1 Trial End)||39.18|-21.37|0.5564
71838622|NCT04473222|143185553|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|1.22||0.734|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.734
71838623|NCT04473222|143185554|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.019|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.019
71838624|NCT04473222|143185555|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.14||0.776|TWO_SIDED||||||t-test, 2 sided||The estimate represents the differential change in slope per week for the intervention group relative to enhanced usual care.|||||0.776
71838625|NCT05505292|143185616|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71838626|NCT05505292|143185617|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71838627|NCT05505292|143185618|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71838628|NCT05505292|143185619|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
71838629|NCT05505292|143185620|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71792241|NCT00449644|143083637|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.2|STANDARD_ERROR_OF_MEAN|7.9||0.008|TWO_SIDED|95.0|5.59|36.83|||Regression, Logistic|Treatment as covariate||Week 24||36.83|5.59|0.008
71792242|NCT00449644|143083637|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|STANDARD_ERROR_OF_MEAN|8.27||0.069|TWO_SIDED|95.0|-1.21|31.51|||Regression, Logistic|Treatment as covariate||Week 72||31.51|-1.21|0.069
71792243|NCT00449644|143083637|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|8.54||0.035|TWO_SIDED|95.0|1.28|35.08|||Regression, Logistic|Treatment as covariate||Week 120||35.08|1.28|0.035
71792244|NCT03642717|143083643|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Glycosylated hemoglobin (HbA1c) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
71792245|NCT03642717|143083646|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in Fasting Plasma Glucose (FPG) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
71792246|NCT03642717|143083647|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in body weight at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
71792247|NCT03642717|143083648|OTHER|||||||0.0076||||||Paired t-test was applied comparing the difference in mean of change in systolic blood pressure (SBP) at Last Visit versus at Baseline.|Paired t-test|||||||0.0076
71792248|NCT03642717|143083649|OTHER||||||<|0.0001||||||Paired t-test was applied comparing the difference in mean of change in diastolic blood pressure (DBP) at Last Visit versus at Baseline.|Paired t-test|||||||< 0.0001
71792249|NCT01559012|143083652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_DEVIATION|2.7||0.001|TWO_SIDED|95.0|1.05|3.32||A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01 and a beta \> 0.90.|Wilcoxon (Mann-Whitney)|Statistical signiﬁcance was assessed by the use of Mann-Whitney U test. P \< 0.05 was deﬁned as statistically signiﬁcant||This is an analysis between groups of intervention clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||3.32|1.05|0.001
71792250|NCT01559012|143083652|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|1.83|||<|0.02|TWO_SIDED|95.0|0.43|3.24|||Wilcoxon (Mann-Whitney)|||This is a within patient variation between clonidine and placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean +/- Standard Deviation (SD).||3.24|0.43|<0.02
71792251|NCT01559012|143083653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.009|TWO_SIDED|95.0|1.78|11.5|||Wilcoxon (Mann-Whitney)|||Analysis within groups clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||11.5|1.78|0.009
71792252|NCT01559012|143083653|NON_INFERIORITY_OR_EQUIVALENCE|A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P \< 0.01|within patient variation|7.5|||<|0.01|TWO_SIDED|95.0|2.17|12.83|||Wilcoxon (Mann-Whitney)|||Analysis within-patient. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.||12.83|2.17|<0.01
71792253|NCT01559012|143083654|SUPERIORITY_OR_OTHER||difference of percentage of positivity|0.3||||0|TWO_SIDED|95.0|0.04|0.47|||Wilcoxon (Mann-Whitney)|||"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"||0.47|0.04|0.000
71792254|NCT01559012|143083655|SUPERIORITY_OR_OTHER||mean values|0.8||||0.013|TWO_SIDED|95.0|0.13|1.57|||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||1.57|0.13|0.013
71792255|NCT01559012|143083656|SUPERIORITY_OR_OTHER||days off-therapy %|29.0||||0.051|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P \< 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .||||0.051
71792256|NCT01559012|143083657|SUPERIORITY_OR_OTHER||proportion|0.0||||0.0089|TWO_SIDED|95.0|||||Fisher Exact|||||||0.0089
71792257|NCT01559012|143083660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.01|TWO_SIDED|95.0|0.9|10.9|||Wilcoxon (Mann-Whitney)|||||10.9|0.9|0.01
71792258|NCT01559012|143083661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.055|TWO_SIDED|95.0|0.3|6.3|||Wilcoxon (Mann-Whitney)|||||6.3|0.3|0.055
71792259|NCT00946712|143083662|OTHER||Hazard Ratio (HR)|0.93||||0.22|TWO_SIDED|95.0|0.83|1.04|||Log Rank|A stratified log rank test was used.||||1.04|0.83|0.22
71792260|NCT00946712|143083663|OTHER||Hazard Ratio (HR)|0.92||||0.4|TWO_SIDED|95.0|0.75|1.12|||Log Rank|A stratified log rank test was used.||||1.12|0.75|0.40
71792261|NCT00946712|143083664|OTHER||Hazard Ratio (HR)|0.81||||0.054|TWO_SIDED|95.0|0.66|1.0|||Log Rank|A stratified log rank test was used.||||1.00|0.66|0.054
71792262|NCT00946712|143083666|OTHER||Hazard Ratio (HR)|0.99||||0.83|TWO_SIDED|95.0|0.88|1.1|||Log Rank|A stratified log rank test was used.||||1.10|0.88|0.83
71792263|NCT00946712|143083668|OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.48
71792264|NCT00946712|143083669|OTHER|||||||0.06|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.||||||0.060
71838630|NCT05505292|143185621|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||0.14
71838631|NCT05505292|143185622|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Question 1a Change from baseline to week 8 in lifitegrast vs vehicle||||0.62
71838632|NCT05505292|143185622|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Question 1b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.53
71838633|NCT05505292|143185622|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Question 2a change from baseline to week 8 in lifitegrast vs vehicle groups||||0.66
71838634|NCT05505292|143185622|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Question 2b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.81
71792265|NCT03759379|143083684|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|2.44|<|1e-07|TWO_SIDED|95.0|-21.78|-12.22||P=3.542E-12|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset) and continuous covariate (baseline value).||-12.22|-21.78|<0.0000001
71892668|NCT03431012|143306709|OTHER||||||=|0.484||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy.||||=0.484
71792266|NCT03759379|143083685|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|-16.2|STANDARD_ERROR_OF_MEAN|2.8|<|1e-07|TWO_SIDED|95.0|-21.7|-10.8||P=5.426E-09|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset baseline NIS) and continuous covariate (baseline value).||-10.8|-21.7|<0.0000001
71792267|NCT03759379|143083686|EQUIVALENCE|H0: No difference between vutrisiran and external placebo comparator (APOLLO): difference (vutrisiran - placebo) = 0|LS Mean Difference|0.131|STANDARD_ERROR_OF_MEAN|0.031|<|1e-07|TWO_SIDED|95.0|0.07|0.193||P=3.103E-05|ANCOVA with Multiple Imputation|||Multiple imputation estimates and p-value derived per combining least squares (LS) estimates per Rubin's rules based on 100 datasets where missing Month 9 values were imputed using a regression procedure including select baseline variables. LS estimates derived from analysis of covariance model, controlling for categorical factors (treatment, genotype, age of disease onset, baseline NIS) and continuous covariate (baseline value).||0.193|0.070|<0.0000001
71792268|NCT01536379|143083699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|95.0|-109.5|40.7||||||||40.7|-109.5|
71792269|NCT01536379|143083720|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|204.35|||||TWO_SIDED|95.0|90.0|550.0|||||Week 24 comparison|||550.00|90.00|
71892669|NCT03431012|143306710|OTHER||||||=|0.494||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to Negative Framing.||||=0.494
71792270|NCT01536379|143083720|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-33.06|||||TWO_SIDED|95.0|-169.84|25.0|||||Week 52 comparison|||25.00|-169.84|
71792271|NCT01536379|143083721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1232.4|STANDARD_ERROR_OF_MEAN|25735.56|||TWO_SIDED|95.0|-50457.0|52921.8|||||Week 24 comparison|||52921.8|-50457.0|
71792272|NCT01536379|143083721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13128.35|STANDARD_ERROR_OF_MEAN|24165.18|||TWO_SIDED|95.0|-61868.9|35612.2|||||Week 52 comparison|||35612.2|-61868.9|
71792273|NCT01536379|143083722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-31.3|3.7|||||Week 24 comparison|||3.7|-31.3|
71892670|NCT01025635|143306716|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|study center adjusted||||||0.017
71792274|NCT01536379|143083722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|7.68|||TWO_SIDED|95.0|-8.6|22.2|||||Week 52 comparison|||22.2|-8.6|
71792275|NCT01536379|143083723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2791.0|STANDARD_ERROR_OF_MEAN|4651.1|||TWO_SIDED|95.0|-12105.0|6524.0|||||Week 24 comparison|||6524|-12105|
71792276|NCT01536379|143083723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-458.0|STANDARD_ERROR_OF_MEAN|4501.8|||TWO_SIDED|95.0|-9487.0|8572.0|||||Week 52 comparison|||8572|-9487|
71792277|NCT01536379|143083724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.156|||TWO_SIDED|95.0|-3.59|1.01|||||Week 24 comparison|||1.01|-3.59|
71792278|NCT01536379|143083724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.017|||TWO_SIDED|95.0|-1.24|2.82|||||Week 52 comparison|||2.82|-1.24|
71792279|NCT01536379|143083725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30326.9|STANDARD_ERROR_OF_MEAN|34677.86|||TWO_SIDED|95.0|-100559.1|39905.3|||||Week 24 comparison|||39905.3|-100559.1|
71792280|NCT01536379|143083725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46955.3|STANDARD_ERROR_OF_MEAN|32594.81|||TWO_SIDED|95.0|-113218.9|19308.3|||||Week 52 comparison|||19308.3|-113218.9|
71792281|NCT01536379|143083726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-10.1|4.2|||||Week 24 comparison|||4.2|-10.1|
71792282|NCT01536379|143083726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-7.2|6.3|||||Week 52 comparison|||6.3|-7.2|
71892671|NCT01025635|143306717|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|with factors treatment group, study center, and baseline lesion count as covariate||||||<0.001
71892672|NCT00929240|143306722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.|Log Rank||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|||0.551|0.266|<0.0001
71677255|NCT03226769|142873140|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4774||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Bothered by Appearance||||0.4774
71892673|NCT00929240|143306722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.429|||<|0.0001|TWO_SIDED|95.0|0.309|0.597|||Log Rank|Unstratified analysis||||0.597|0.309|<0.0001
71892674|NCT00929240|143306723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.113|TWO_SIDED|95.0|-2.1|20.3|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.|||20.3|-2.1|0.113
71892675|NCT00929240|143306724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.58|TWO_SIDED|95.0|-2.6|4.6|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.|||4.6|-2.6|0.580
71792283|NCT01536379|143083727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|648.3|STANDARD_ERROR_OF_MEAN|12618.44|||TWO_SIDED|95.0|-24661.1|25957.7|||||Week 24 comparison|||25957.7|-24661.1|
71792284|NCT01536379|143083727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5618.9|STANDARD_ERROR_OF_MEAN|12153.03|||TWO_SIDED|95.0|-29994.8|18757.0|||||Week 52 comparison|||18757.0|-29994.8|
71792285|NCT01536379|143083728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|-3.2|3.5|||||Week 24 comparison|||3.5|-3.2|
71792286|NCT01536379|143083728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-3.5|2.3|||||Week 52 comparison|||2.3|-3.5|
71792287|NCT01536379|143083729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|1.255|||TWO_SIDED|95.0|-4.07|0.98|||||Week 24 comparison|||0.98|-4.07|
71792288|NCT01536379|143083729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.329|||TWO_SIDED|95.0|-3.68|1.67|||||Week 52 comparison|||1.67|-3.68|
71792289|NCT01536379|143083730|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.067|||||TWO_SIDED|95.0|-0.638|0.505|||||Week 24 comparison|||0.505|-0.638|
71792290|NCT01536379|143083730|SUPERIORITY_OR_OTHER||Difference in Proportion|-0.267|||||TWO_SIDED|95.0|-0.838|0.305|||||Week 52 comparison|||0.305|-0.838|
71792291|NCT01536379|143083731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|52.06|||TWO_SIDED|95.0|-105.9|100.3|||||Week 24 comparison|||100.3|-105.9|
71792292|NCT01536379|143083731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|47.52|||TWO_SIDED|95.0|-107.1|81.4|||||Week 52 comparison|||81.4|-107.1|
71792293|NCT01536379|143083732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-31.56|5.71|||||Week 24 comparison|||5.71|-31.56|
71677256|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.5457||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyes||||0.5457
71792294|NCT01536379|143083732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|8.315|||TWO_SIDED|95.0|-19.11|13.72|||||Week 52 comparison|||13.72|-19.11|
71792295|NCT01536379|143083733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.225|||TWO_SIDED|95.0|-4.84|3.96||||||||3.96|-4.84|
71892676|NCT00929240|143306726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0003|TWO_SIDED|95.0|0.263|0.685||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank|||||0.685|0.263|<0.0003
71792296|NCT01280552|143083736|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Stratified for age and MGMT methylation status|Log Rank|||Stratified log rank p value stratified for age and MGMT methylation status||||0.010
71792297|NCT01280552|143083738|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Analyses were stratified for age and MGMT methylation status.|Log Rank|||||||0.033
71792298|NCT02603809|143083739|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
71792299|NCT02603809|143083739|SUPERIORITY||LS Mean|-1.31|STANDARD_ERROR_OF_MEAN|1.548||0.8117|TWO_SIDED|95.0|-5.1|2.49|||ANCOVA|with Dunnett correction.||||2.49|-5.10|0.8117
71792300|NCT02603809|143083739|SUPERIORITY||LS Mean|-4.93|STANDARD_ERROR_OF_MEAN|1.532||0.0053|TWO_SIDED|95.0|-8.68|-1.17|||ANCOVA|with Dunnett correction.||||-1.17|-8.68|0.0053
71792301|NCT02603809|143083739|SUPERIORITY||LS Mean|-6.99|STANDARD_ERROR_OF_MEAN|1.554|<|0.0001|TWO_SIDED|95.0|-10.8|-3.19|||ANCOVA|with Dunnett correction.||||-3.19|-10.80|<.0001
71792302|NCT02603809|143083739|SUPERIORITY||LS Mean|-4.95|STANDARD_ERROR_OF_MEAN|1.549||0.0057|TWO_SIDED|95.0|-8.75|-1.15|||ANCOVA|with Dunnett correction.||||-1.15|-8.75|0.0057
71792303|NCT02603809|143083740|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran-rprojects.org/web/packages/DoseFinding.)"||||<0.001
71892677|NCT00929240|143306726|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.516||||0.002|TWO_SIDED|95.0|0.334|0.798||Unstratified analysis|Log Rank|||||0.798|0.334|0.002
71892678|NCT00929240|143306729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.383|||<|0.0001|TWO_SIDED|95.0|0.266|0.551||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.|||0.551|0.266|<0.0001
71892679|NCT00929240|143306729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.305|0.591||Unstratified analysis|Log Rank||Hazard ratio was determined using the cox regression model.|||0.591|0.305|<0.0001
71892680|NCT05292755|143306733|OTHER|One-way ANOVA was used to compare mean Faith's phylogenetic diversity before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||||0.232|||||||ANOVA|||||||0.232
71892681|NCT05292755|143306734|OTHER|||||||0.224|||||||ANOVA|||ANOVA was used to compare mean Shannon's diversity indices before and after treatment for each intervention group at a two-tailed 95% confidence interval.||||0.224
71892682|NCT05292755|143306735|OTHER|||||||0.227|||||||Repeated measures Mann-U-Whitney|||Repeated measures Mann-U-Whitney tests were used to compare changes in weighted and unweighted UniFrac distances between intervention groups before and after intervention at a two-tailed 95% confidence interval.||||0.227
71892683|NCT00432809|143306741|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
71677257|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.9786||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Blurred Vision||||0.9786
71792304|NCT02603809|143083740|SUPERIORITY||LS Mean|-2.45|STANDARD_ERROR_OF_MEAN|2.445||0.7071|TWO_SIDED|95.0|-8.44|3.54|||ANCOVA|with Dunnett correction.||||3.54|-8.44|0.7071
71792305|NCT02603809|143083740|SUPERIORITY||LS Mean|-7.05|STANDARD_ERROR_OF_MEAN|2.42||0.0138|TWO_SIDED|95.0|-12.98|-1.12|||ANCOVA|with Dunnett correction.||||-1.12|-12.98|0.0138
71792306|NCT02603809|143083740|SUPERIORITY||LS Mean|-9.9|STANDARD_ERROR_OF_MEAN|2.457||0.0003|TWO_SIDED|95.0|-15.92|-3.88|||ANCOVA|with Dunnett correction.||||-3.88|-15.92|0.0003
71792307|NCT02603809|143083740|SUPERIORITY||LS Mean|-7.58|STANDARD_ERROR_OF_MEAN|0.0077||0.0077|TWO_SIDED|95.0|-13.58|-1.59|||ANCOVA|with Dunnett correction.||||-1.59|-13.58|0.0077
71792308|NCT02603809|143083746|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"||||<0.001
71792309|NCT02603809|143083746|SUPERIORITY||LS Mean|-1.75|STANDARD_ERROR_OF_MEAN|1.401||0.5356|TWO_SIDED|95.0|-5.19|1.69|||ANCOVA|with Dunnett correction.||||1.69|-5.19|0.5356
71792310|NCT02603809|143083746|SUPERIORITY||LS Mean|-5.82|STANDARD_ERROR_OF_MEAN|1.396||0.0001|TWO_SIDED|95.0|-9.25|-2.4|||ANCOVA|with Dunnett correction.||||-2.40|-9.25|0.0001
71792311|NCT02603809|143083746|SUPERIORITY||LS Mean|-7.5|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-10.96|-4.04|||ANCOVA|with Dunnett correction.||||-4.04|-10.96|<.0001
71892684|NCT00432809|143306741|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
71892685|NCT00432809|143306741|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||Not adjusted for multiple comparisons|Chi-squared|||||||0.59
71892686|NCT00432809|143306745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71792312|NCT02603809|143083746|SUPERIORITY||LS Mean|-5.65|STANDARD_ERROR_OF_MEAN|1.41||0.0003|TWO_SIDED|95.0|-9.11|-2.19|||ANCOVA|with Dunnett correction.||||-2.19|-9.11|0.0003
71792313|NCT03036098|143083759|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0032|TWO_SIDED|95.0|0.64|0.97|||Log Rank|Stratified weighted log-rank test||||0.97|0.64|0.0032
71792314|NCT03036098|143083766|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0018|TWO_SIDED|95.0|0.59|0.88|||Log Rank|Stratified weighted log-rank test||||0.88|0.59|0.0018
71792315|NCT03036098|143083767|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0171|TWO_SIDED|95.0|0.63|0.96|||Log Rank|Stratified weighted log-rank test||||0.96|0.63|0.0171
71792316|NCT01046682|143083785|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon rank sum test|||Using data from a different population, ie, patients with peripheral artery disease, and a different intervention, ie, omega-3 fatty acids, 15 participants were needed per group to achieve 80% power to detect a difference in means of -3.6% (the difference between the control group mean of -0.3% and a treatment group mean of 3.3%) assuming a common standard deviation of 3.3 using a two group t-test with a 0.05 two-sided significance level. 5 patients added to each arm in case nonparametric.||||<0.05
71792317|NCT01265849|143083789|SUPERIORITY|||||||0.4051||||||For the primary efficacy measure a two-sided p-value of 0.05 or less is considered to be statistically significant in comparing the LI+CIZ+SOC treatment vs. SOC alone for superiority.|Log Rank|Log Rank statistic is based on an unstratified analysis.||The primary objective was to compare overall survival in the LI + CIZ + SOC group to that in the SOC alone group for superiority of the former.||||0.4051
71792318|NCT01265849|143083789|SUPERIORITY|||||||0.5402|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.5402
71792319|NCT01265849|143083789|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4128|TWO_SIDED|95.0|0.89|1.32|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.32|0.89|0.4128
71892687|NCT00432809|143306745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892688|NCT00432809|143306745|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
71892689|NCT00432809|143306746|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
71892690|NCT00432809|143306746|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
71892691|NCT00432809|143306746|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.86
71892692|NCT00432809|143306747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892693|NCT00432809|143306747|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||||||0.003
71892694|NCT00432809|143306747|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||||||0.23
71892695|NCT00432809|143306748|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Medical Therapy vs. Gastric Bypass||||<0.001
71892696|NCT00432809|143306748|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892697|NCT00432809|143306748|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Chi-squared|||||||0.10
71892698|NCT00432809|143306749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892699|NCT00432809|143306749|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71672351|NCT01120184|142863127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (\<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.91||||0.3125|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3125
71677258|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3894||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Dry Eyes||||0.3894
71792320|NCT01265849|143083789|SUPERIORITY|||||||0.7181|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.7181
71792321|NCT01265849|143083789|SUPERIORITY|||||||0.948|||||||Log Rank|This log Rank p-value is based on a stratified analysis.||||||0.9480
71792322|NCT01265849|143083789|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6101|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A hazard Ratio \< 1.0 would favor LI + SOC.|||1.42|0.81|0.6101
71792323|NCT01265849|143083790|SUPERIORITY|||||||0.0478|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.0478
71792324|NCT01265849|143083790|SUPERIORITY|||||||0.0137|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0137
71792325|NCT01265849|143083790|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0236|TWO_SIDED|95.0|0.48|0.95|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||0.95|0.48|0.0236
71792326|NCT01265849|143083790|SUPERIORITY|||||||0.4115|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.4115
71792327|NCT01265849|143083790|SUPERIORITY|||||||0.2862|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.|||This HR is presented as (LI + SOC) / SOC. A HR \< 1.0 favors LI+SOC. Wald p-value for this HR is 0.3859.|||0.2862
71792328|NCT01265849|143083790|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3859|TWO_SIDED|95.0|0.52|1.29|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.29|0.52|0.3859
71792329|NCT01265849|143083791|SUPERIORITY|||||||0.7304||||||P-values are not adjusted for multiple comparisons.|Log Rank|This Log Rank P-value is based on an unstratified analysis.||The secondary endpoint LRC failure is analyzed similar to the primary OS endpoint. The primary comparison is LI+CIZ+SOC vs SOC; LI+SOC vs SOC results are also reported.||||0.7304
71792330|NCT01265849|143083791|SUPERIORITY|||||||0.7171||||||P-values are reported unadjusted for multiplicity.|Log Rank|The Log Rank statistic is based on a stratified analysis.||||||0.7171
71792331|NCT01265849|143083791|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.802|TWO_SIDED|95.0|0.79|1.36|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.36|0.79|0.8020
71792332|NCT01265849|143083791|SUPERIORITY|||||||0.4231|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.4231
71792333|NCT01265849|143083791|SUPERIORITY|||||||0.6998|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6998
71792334|NCT01265849|143083791|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3944|TWO_SIDED|95.0|0.81|1.69|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.69|0.81|0.3944
71892700|NCT00432809|143306749|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
71892701|NCT00432809|143306750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892702|NCT00432809|143306750|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892703|NCT00432809|143306750|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.02
71892704|NCT00432809|143306751|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892705|NCT00432809|143306751|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892706|NCT00432809|143306751|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||ANOVA|||||||0.61
71792335|NCT01265849|143083792|SUPERIORITY|||||||0.6142|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.6142
71792336|NCT01265849|143083792|SUPERIORITY|||||||0.3024|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.3024
71792337|NCT01265849|143083792|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.42082|TWO_SIDED|95.0|0.55|1.28|||Regression, Cox||A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.28|0.55|0.42082
71892707|NCT00432809|143306752|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892708|NCT00432809|143306752|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71892709|NCT00432809|143306752|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||||||0.03
71892710|NCT00432809|143306753|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
71892711|NCT00432809|143306753|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
71892712|NCT00432809|143306753|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
71892713|NCT00432809|143306754|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
71892714|NCT00432809|143306754|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||||||0.001
71892715|NCT00432809|143306754|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||ANOVA|||||||0.98
71792338|NCT01265849|143083792|SUPERIORITY|||||||0.9784|||||||Log Rank|The Log Rank statistic is based on an unstratified analysis.||||||0.9784
71672352|NCT01120184|142863127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was \<1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \<1.00.|Hazard Ratio (HR)|0.87||||0.1407|TWO_SIDED|97.5|0.69|1.08||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.08|0.69|0.1407
71672353|NCT01120184|142863127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Hazard Ratio (HR)|0.91||||0.3075|TWO_SIDED|97.5|0.73|1.13||Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.13|0.73|0.3075
71672354|NCT01120184|142863129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.6568|TWO_SIDED|97.5|0.73|1.2|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.20|0.73|0.6568
71672355|NCT01120184|142863129|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.5691|TWO_SIDED|97.5|0.67|1.11|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.11|0.67|0.5691
71672356|NCT01120184|142863131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|97.5|0.69|1.04|||||Direction of comparison: Trastuzumab Emtasine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||1.04|0.69|
71672357|NCT01120184|142863131|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|97.5|0.63|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.63|
71672358|NCT01120184|142863133|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|97.5|0.66|0.97|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.97|0.66|
71838635|NCT05505292|143185622|SUPERIORITY||||||>|0.999|||||||Wilcoxon (Mann-Whitney)|||Question 3a change from baseline to week 8 in lifitegrast vs vehicle groups||||>0.999
71792339|NCT01265849|143083792|SUPERIORITY|||||||0.8461||||||This Log Rank statistic is based on a stratified analysis.|Log Rank|||||||0.8461
71838636|NCT05505292|143185622|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Question 3b change from baseline to week 8 in lifitegrast vs vehicle groups||||0.47
71838637|NCT05505292|143185622|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Question 4 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.52
71838638|NCT05505292|143185622|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Question 5 change from baseline to week 8 in lifitegrast vs vehicle groups||||0.69
71838639|NCT01073566|143185637|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.24||0.098|TWO_SIDED|95.0|-0.97|0.16|||ANOVA||Finesse versus usual injection device.|A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||0.16|-0.97|0.098
71792340|NCT01265849|143083792|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8131|TWO_SIDED|95.0|0.53|1.65|||Regression, Cox||A Hazard Ratio of \< 1.0 would favor LI + SOC.|||1.65|0.53|0.8131
71792341|NCT01265849|143083793|SUPERIORITY|||||||0.3303|||||||Log Rank|This Log Rank statistic is from an unstratified analysis.||This secondary endpoint PFS is analyzed similar to OS and LRC.||||0.3303
71792342|NCT01265849|143083793|SUPERIORITY|||||||0.6669|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.6669
71838640|NCT01073566|143185638|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.8|-0.17|||ANOVA||Finesse versus usual injection device|This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.||-0.17|-0.80|0.004
71892716|NCT00432809|143306755|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71792343|NCT01265849|143083793|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3728|TWO_SIDED|95.0|0.9|1.31|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + CIZ + SOC.|||1.31|0.90|0.3728
71792344|NCT01265849|143083793|SUPERIORITY|||||||0.5739|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5739
71792345|NCT01265849|143083793|SUPERIORITY|||||||0.8162|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.8162
71792346|NCT01265849|143083793|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.4728|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.43|0.84|0.4728
71792347|NCT01265849|143083794|SUPERIORITY|||||||0.1797|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.1797
71792348|NCT01265849|143083794|SUPERIORITY|||||||0.0159|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.0159
71792349|NCT01265849|143083794|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0896|TWO_SIDED|95.0|0.55|1.04|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio of \< 1.0 would favor LI + CIZ + SOC.|||1.04|0.55|0.0896
71792350|NCT01265849|143083794|SUPERIORITY|||||||0.5175|||||||Log Rank|This Log Rank statistic is based on an unstratified analysis.||||||0.5175
71792351|NCT01265849|143083794|SUPERIORITY|||||||0.453|||||||Log Rank|This Log Rank statistic is based on a stratified analysis.||||||0.4530
71792352|NCT01265849|143083794|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4376|TWO_SIDED|95.0|0.54|1.3|||Regression, Cox|The Cox Proportional Hazards Model included terms for treatment, tumor stage, tumor location, and geographic region.|A Hazard Ratio \< 1.0 would favor LI + SOC.|||1.30|0.54|0.4376
71792353|NCT01265849|143083795|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|2.395||0.21|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|Approximately 30% of participants completed the QOL instrument at first administration (Month2), thus the study did not have the power for QoL comparisons. These completer analyses are descriptive only.||||0.2100
71792354|NCT01265849|143083795|SUPERIORITY||Mean Difference (Net)|4.67|STANDARD_ERROR_OF_MEAN|3.401||0.1701|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|Approximately 30% of participants completed the QOL instrument at last administration (Month 36), thus the study did not have power for QoL comparisons. These completer analyses are descriptive only.||||0.1701
71792355|NCT01265849|143083796|SUPERIORITY|This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Median Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.397||0.5871|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|LI + CIZ + SOC, Standard of Care (SOC)||||0.5871
71792356|NCT01265849|143083796|SUPERIORITY||Mean Difference (Net)|4.46|STANDARD_ERROR_OF_MEAN|3.247||0.17|TWO_SIDED|||||This p-value for Long Term Follow-up at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Positive value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.1700
71792357|NCT01265849|143083797|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|2.183||0.6296|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6296
71792358|NCT01265849|143083797|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|3.103||0.7454|TWO_SIDED|||||This p-value for head and neck pain at Long Term Follow-up Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7454
71792359|NCT01265849|143083797|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|2.465||0.7452|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, tumor location \& stage, geographic region, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.7452
71792360|NCT01265849|143083797|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|3.496||0.771|TWO_SIDED|||||This p-value for Long Term Follow-up for swallowing at Month 2 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed effects of treatment, visit, treatment by visit, and baseline with compound symmetry.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.7710
71792361|NCT01265849|143083798|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|2.185||0.6337|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + CIZ + SOC.|||||0.6337
71838641|NCT01073566|143185639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||McNemar|||Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.||||<0.001
71838642|NCT03865498|143185673|SUPERIORITY||Odds Ratio (OR)|7.029|||<|0.0001|TWO_SIDED|95.0|4.919|10.323||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for African American dementia caregiver networks.||10.323|4.919|< 0.0001
71672359|NCT01120184|142863133|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|97.5|0.65|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.95|0.65|
71672360|NCT01120184|142863143|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-8.2|||||TWO_SIDED|95.0|-15.9|-0.5|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||-0.5|-15.9|
71672361|NCT01120184|142863143|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-3.7|||||TWO_SIDED|95.0|-11.4|3.9|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||3.9|-11.4|
71672362|NCT01120184|142863143|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|4.5|||||TWO_SIDED|95.0|-3.3|12.2|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||12.2|-3.3|
71792362|NCT01265849|143083798|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|2.962||0.945|TWO_SIDED|||||This p-value for Long Term Follow-up for head and neck pain at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.9450
71792363|NCT01265849|143083798|SUPERIORITY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.465||0.4071|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI+ CIZ + SOC.|||||0.4071
71672363|NCT01120184|142863144|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-4.6|||||TWO_SIDED|95.0|-12.1|2.8|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||2.8|-12.1|
71792364|NCT01265849|143083798|SUPERIORITY||Mean Difference (Net)|-7.29|STANDARD_ERROR_OF_MEAN|3.347||0.0296|TWO_SIDED|||||This p-value for Long Term Follow-up for Swallowing at Month 36 is not adjusted for multiplicity.|Repeated Measures ANCOVA (RMANCOVA)|RMANCOVA with fixed stratification factors, trt, visit, trt\*visit, and baseline, with a compound symmetry correlation structure.|Negative value for the difference (Mean Difference (Net)) favors LI + SOC.|||||0.0296
71792365|NCT01265849|143083799|SUPERIORITY|Statistical tests were for a significant treatment effect in the Cox Proportional Hazards model including treatment, disease stage, tumor location, and geographical region.|% of significant test results|21.6|||<|0.05|TWO_SIDED|95.0|17.0|26.9||"Under the null hypothesis of no effect the expected number of significant test results would be balanced between treatments.~The expected number (%) of statistically significant results would be approximately 14 (5%) of 282."|Regression, Cox|||"Treatment comparisons of LI+CIZ+SOC v. SOC were repeated at all levels of HP, HP ratios, and HP combinations for endpoints OS, PFS, and LRC.~Significant outcomes for the treatment term in the model (two-sided p\<0.05) were accumulated."||26.9|17.0|<0.05
71792366|NCT01265849|143083800|SUPERIORITY||Percent (%) of Participants|8.1|||<|0.0001|TWO_SIDED|95.0|5.6|11.2|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||11.2|5.6|<.0001
71792367|NCT01265849|143083800|SUPERIORITY||Percent (%) of Participants|9.7|||<|0.0001|TWO_SIDED|95.0|4.7|14.7|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||14.7|4.7|<0.0001
71792368|NCT01265849|143083801|SUPERIORITY||Percent (%) of Participants|15.2|||<|0.0001|TWO_SIDED|95.0|9.6|20.8|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + CIZ + SOC and SOC.||20.8|9.6|<0.0001
71792369|NCT01265849|143083801|SUPERIORITY||Percent (%) of Participants|18.5|||<|0.0001|TWO_SIDED|95.0|8.2|28.9|||Fisher Exact|||Null hypothesis is that percent (%) of participants with an objective response (CR+PR) is the same for LI + SOC and SOC.||28.9|8.2|<0.0001
71792370|NCT01265849|143083802|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI + CIZ + SOC.||||0.0007
71792371|NCT01265849|143083802|SUPERIORITY|||||||0.0434|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative that response is predictive of increased survival in subjects receiving LI + SOC.||||0.0434
71792372|NCT01265849|143083802|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.||||<0.0001
71792373|NCT01265849|143083803|SUPERIORITY|||||||0.0101|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + CIZ + SOC.||||0.0101
71672364|NCT01120184|142863144|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|-1.8|||||TWO_SIDED|95.0|-9.2|5.7|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|||5.7|-9.2|
71672365|NCT01120184|142863144|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rate|2.9|||||TWO_SIDED|95.0|-4.5|10.3|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|||10.3|-4.5|
71792374|NCT01265849|143083803|SUPERIORITY|||||||0.4843|||||||Fisher Exact|||The null hypothesis that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for low risk participants receiving LI + SOC.||||0.4843
71792375|NCT01265849|143083803|SUPERIORITY||||||<|0.0067||||||The null hypothesis is that survival is unrelated to objective response versus the alternative hypothesis that objective response is predictive of increased survival for participants receiving LI, considering both treatment groups combined.|Fisher Exact|||||||<0.0067
71792376|NCT01265849|143083804|SUPERIORITY||Hazard Ratio (HR)|0.348||||0.0131|TWO_SIDED|95.0|0.152|0.801|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI (combined arms LI + CIZ + SOC, LI + SOC) is \>=1.0 versus the alternative hypothesis that subjects responding to LI are at reduced risk of death (HR \< 1.0).||0.801|0.152|0.0131
71892717|NCT00432809|143306755|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.08
71672366|NCT01120184|142863145|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|97.5|0.43|0.84|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.43|
71672367|NCT01120184|142863145|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|97.5|0.45|0.85|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.85|0.45|
71672368|NCT01120184|142863147|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-32.2|||||TWO_SIDED|95.0|-40.0|-24.0|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-24|-40|
71792377|NCT01265849|143083804|SUPERIORITY||Hazard Ratio (HR)|0.246||||0.0181|TWO_SIDED|95.0|0.077|0.787|||Regression, Cox|||Null hypothesis is that the Hazard Ratio (HR) for low risk subjects responding to LI + CIZ + SOC is \>=1.0 versus the alternative hypothesis that subjects responding to LI + CIZ + SOC are at reduced risk of death (HR \< 1.0).||0.787|0.077|0.0181
71792378|NCT02188589|143083811|EQUIVALENCE|The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p\<0.05.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71672369|NCT01120184|142863147|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|-24.2|||||TWO_SIDED|95.0|-32.0|-16.0|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||-16|-32|
71672370|NCT01120184|142863147|SUPERIORITY_OR_OTHER_LEGACY||Difference in Symptom Rate|8.0|||||TWO_SIDED|95.0|-2.3|18.4|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||18.4|-2.3|
71792379|NCT00867451|143083813|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<.05
71792380|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.8096|||<|0.0001|TWO_SIDED|95.0|15.0866|26.5327|||Mixed Models Analysis|Mixed-effect model was implemented with Restricted Maximum Likelihood (REML) estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95 percent (%) Confidence Interval (CI) were obtained from the model.||26.5327|15.0866|<0.0001
71792381|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4625|||<|0.0001|TWO_SIDED|95.0|18.7321|30.1929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1929|18.7321|<0.0001
71792382|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5792||||0.8428|TWO_SIDED|95.0|-6.3385|5.18|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.1800|-6.3385|0.8428
71792383|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9993||||0.4957|TWO_SIDED|95.0|-7.7832|3.7845|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.7845|-7.7832|0.4957
71792384|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9683||||0.7431|TWO_SIDED|95.0|-4.8567|6.7932|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.7932|-4.8567|0.7431
71792385|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.3889|||<|0.0001|TWO_SIDED|95.0|-27.1044|-15.6734|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.6734|-27.1044|<0.0001
71792386|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.809|||<|0.0001|TWO_SIDED|95.0|-28.5584|-17.0596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.0596|-28.5584|<0.0001
71792387|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-19.8414|||<|0.0001|TWO_SIDED|95.0|-25.6435|-14.0393|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.0393|-25.6435|<0.0001
71792388|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0418|||<|0.0001|TWO_SIDED|95.0|-30.6705|-19.413|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.4130|-30.6705|<0.0001
71792389|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4618|||<|0.0001|TWO_SIDED|95.0|-32.1455|-20.7782|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.7782|-32.1455|<0.0001
71792390|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.4943|||<|0.0001|TWO_SIDED|95.0|-29.244|-17.7445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.7445|-29.2440|<0.0001
71792391|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4538||||0.572|TWO_SIDED|95.0|-6.5274|3.6198|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.6198|-6.5274|0.5720
71792392|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9938||||0.0006|TWO_SIDED|95.0|-14.0695|-3.918|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.9180|-14.0695|0.0006
71792393|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8686||||0.4704|TWO_SIDED|95.0|-3.2342|6.9713|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9713|-3.2342|0.4704
71792394|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0725||||0.4255|TWO_SIDED|95.0|-3.0533|7.1984|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1984|-3.0533|0.4255
71792395|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3425||||0.8959|TWO_SIDED|95.0|-5.5053|4.8204|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.8204|-5.5053|0.8959
71792396|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3224||||0.1967|TWO_SIDED|95.0|-1.7402|8.385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.3850|-1.7402|0.1967
71792397|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5264||||0.1733|TWO_SIDED|95.0|-1.5676|8.6203|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.6203|-1.5676|0.1733
71792398|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1113||||0.6697|TWO_SIDED|95.0|-4.0285|6.2512|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2512|-4.0285|0.6697
71838643|NCT03865498|143185673|SUPERIORITY||Odds Ratio (OR)|17.385|||<|0.0001|TWO_SIDED|95.0|9.963|33.157||McNemar's Chi-squared test (paired) with continuity correction to the test slightly more conservative|McNemar|||Hypothesis: There will be significant pre/post-intervention differences in isolated macro-level network structures for Hispanic dementia caregiver networks.||33.157|9.963|<0.0001
71892718|NCT00432809|143306755|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.17
71672371|NCT01120184|142863151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.57|0.86|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.86|0.57|
71672372|NCT01120184|142863151|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.55|0.84|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \[trastuzumab and/or lapatinib\], yes \[no trastuzumab and/or lapatinib\]), and visceral disease (present, absent).||0.84|0.55|
71892719|NCT00432809|143306756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71792399|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8623|||<|0.0001|TWO_SIDED|95.0|5.8712|15.8535|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.8535|5.8712|<0.0001
71792400|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0663|||<|0.0001|TWO_SIDED|95.0|6.0281|16.1045|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1045|6.0281|<0.0001
71792401|NCT00975481|143083821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6513||||0.001|TWO_SIDED|95.0|3.5552|13.7474|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7474|3.5552|0.0010
71792402|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6388|||<|0.0001|TWO_SIDED|95.0|10.5727|22.7049|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||22.7049|10.5727|<0.0001
71792403|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.8432|||<|0.0001|TWO_SIDED|95.0|13.7627|25.9238|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.9238|13.7627|<0.0001
71792404|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6121||||0.6029|TWO_SIDED|95.0|-7.7209|4.4967|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4967|-7.7209|0.6029
71792405|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9241||||0.3477|TWO_SIDED|95.0|-9.0571|3.2089|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.2089|-9.0571|0.3477
71792406|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0908||||0.9769|TWO_SIDED|95.0|-6.085|6.2667|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2667|-6.0850|0.9769
71792407|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2509|||<|0.0001|TWO_SIDED|95.0|-24.3155|-12.1864|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-12.1864|-24.3155|<0.0001
71892720|NCT00432809|143306756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71892721|NCT00432809|143306756|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.59
71892722|NCT00432809|143306757|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892723|NCT00432809|143306757|SUPERIORITY_OR_OTHER|||||||1.001||95.0|||||Chi-squared|||||||1.001
71892724|NCT00432809|143306757|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Chi-squared|||||||0.68
71892725|NCT00432809|143306758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71672373|NCT01120184|142863155|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.4|1.15|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.15|0.40|
71672374|NCT01120184|142863156|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.66|||||TWO_SIDED|95.0|0.41|1.07|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.07|0.41|
71672375|NCT01120184|142863158|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|97.5|0.65|1.25|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.25|0.65|
71672376|NCT01120184|142863160|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|97.5|0.74|1.34|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|||1.34|0.74|
71672377|NCT04003636|142863165|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0034|TWO_SIDED|95.0|0.72|0.95|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||0.95|0.72|0.0034
71672378|NCT04003636|142863166|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0225|TWO_SIDED|95.0|0.75|1.0|||Regression, Cox|One-sided p-value based on log-rank test stratified by geographic region, disease status, site of origin with small strata collapsed|HR=Arm A/Arm B|||1.00|0.75|0.0225
71672379|NCT04003636|142863167|SUPERIORITY||Difference in Percentages|0.2||||0.4735|TWO_SIDED|95.0|-5.2|5.6||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0|Miettinen & Nurminen||Difference=Arm A minus Arm B|||5.6|-5.2|0.4735
71672380|NCT03656068|142863184|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.003||||0.0039|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0039
71672381|NCT03656068|142863185|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|10.0||||0.0026|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.0026
71672382|NCT03656068|142863186|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|0.002||||0.5555|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.5555
71672383|NCT03656068|142863187|OTHER|Wilcoxon signed-rank test was used for statistical inference.|Median Difference (Net)|1.72||||0.3778|TWO_SIDED|||||p-value for testing median = 0|Sign test|||||||0.3778
71672384|NCT03656068|142863188|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.1||||0.4638|TWO_SIDED|95.0|-31.0|14.8||p-value for testing mean = 0|t-test, 2 sided|||||14.8|-31.0|0.4638
71672385|NCT03656068|142863189|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.65||||0.6532|TWO_SIDED|95.0|-9.26|5.97||p-value for testing mean = 0|t-test, 2 sided|||||5.97|-9.26|0.6532
71672386|NCT03656068|142863190|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.7254|TWO_SIDED|95.0|-1.86|2.61||p-value for testing mean = 0|t-test, 2 sided|||||2.61|-1.86|0.7254
71672387|NCT03656068|142863191|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.77||||0.3772|TWO_SIDED|95.0|-11.7|29.25||p-value for testing mean = 0|t-test, 2 sided|||||29.25|-11.70|0.3772
71892726|NCT00432809|143306758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71672388|NCT03656068|142863192|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.5799|TWO_SIDED|95.0|-0.56|0.33||p-value for testing mean = 0|t-test, 2 sided|||||0.33|-0.56|0.5799
71672389|NCT03656068|142863193|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.89||||0.7088|TWO_SIDED|95.0|-12.65|8.87||p-value for testing mean = 0|t-test, 2 sided|||||8.87|-12.65|0.7088
71672390|NCT03656068|142863194|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.35||||0.0609|TWO_SIDED|95.0|-0.72|0.02||p-value for testing mean = 0|t-test, 2 sided|||||0.02|-0.72|0.0609
71672391|NCT03656068|142863195|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.61||||0.1556|TWO_SIDED|95.0|-16.16|2.94||p-value for testing mean = 0|t-test, 2 sided|||||2.94|-16.16|0.1556
71672392|NCT03656068|142863196|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-14.6||||0.0709|TWO_SIDED|95.0|-30.6|1.4||p-value for testing mean = 0|t-test, 2 sided|||||1.4|-30.6|0.0709
71672393|NCT03656068|142863197|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.61||||0.1799|TWO_SIDED|95.0|-9.02|1.81||p-value for testing mean = 0|t-test, 2 sided|||||1.81|-9.02|0.1799
71672394|NCT03656068|142863198|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-6.8||||0.3306|TWO_SIDED|95.0|-21.2|7.6||p-value for testing mean = 0|t-test, 2 sided|||||7.6|-21.2|0.3306
71672395|NCT03656068|142863199|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-1.94||||0.4504|TWO_SIDED|95.0|-7.25|3.37||p-value for testing mean = 0|t-test, 2 sided|||||3.37|-7.25|0.4504
71672396|NCT03656068|142863200|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|33.8||||0.1349|TWO_SIDED|95.0|-11.5|79.0||p-value for testing mean = 0|t-test, 2 sided|||||79.0|-11.5|0.1349
71672397|NCT03656068|142863201|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|76.24||||0.0117|TWO_SIDED|95.0|19.04|133.43||p-value for testing mean = 0|t-test, 2 sided|||||133.43|19.04|0.0117
71672398|NCT03656068|142863202|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|31.3||||0.4281|TWO_SIDED|95.0|-50.3|112.9||p-value for testing mean = 0|t-test, 2 sided|||||112.9|-50.3|0.4281
71672399|NCT03656068|142863203|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|117.37||||0.0407|TWO_SIDED|95.0|5.6|229.14||p-value for testing mean = 0|t-test, 2 sided|||||229.14|5.60|0.0407
71672400|NCT03656068|142863204|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|47.28||||0.7065|TWO_SIDED|95.0|-210.9|305.46||p-value for testing mean = 0|t-test, 2 sided|||||305.46|-210.90|0.7065
71672401|NCT03656068|142863205|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|43.11||||0.1693|TWO_SIDED|95.0|-19.95|106.17||p-value for testing mean = 0|t-test, 2 sided|||||106.17|-19.95|0.1693
71672402|NCT03656068|142863206|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-48.14||||0.7099|TWO_SIDED|95.0|-317.64|221.36||p-value for testing mean = 0|t-test, 2 sided|||||221.36|-317.64|0.7099
71672403|NCT03656068|142863207|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.03||||0.3597|TWO_SIDED|95.0|-37.48|97.55||p-value for testing mean = 0|t-test, 2 sided|||||97.55|-37.48|0.3597
71672404|NCT03656068|142863208|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|169.0||||0.9893|TWO_SIDED|95.0|-25908.2|26246.2||p-value for testing mean = 0|t-test, 2 sided|||||26246.2|-25908.2|0.9893
71672405|NCT03656068|142863209|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|13.82||||0.1454|TWO_SIDED|95.0|-5.21|32.85||p-value for testing mean = 0|t-test, 2 sided|||||32.85|-5.21|0.1454
71892727|NCT00432809|143306758|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
71792408|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5629|||<|0.0001|TWO_SIDED|95.0|-25.6616|-13.4642|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.4642|-25.6616|<0.0001
71792409|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.548|||<|0.0001|TWO_SIDED|95.0|-22.7036|-10.3923|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.3923|-22.7036|<0.0001
71792410|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4554|||<|0.0001|TWO_SIDED|95.0|-27.4199|-15.4908|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.4908|-27.4199|<0.0001
71792411|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7673|||<|0.0001|TWO_SIDED|95.0|-28.7925|-16.7422||Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Mixed Models Analysis|||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.7422|-28.7925|<0.0001
71792412|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7524|||<|0.0001|TWO_SIDED|95.0|-25.8485|-13.6563|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-13.6563|-25.8485|<0.0001
71792413|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.0888||||0.0006|TWO_SIDED|95.0|5.3225|18.8551|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.8551|5.3225|0.0006
71792414|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0768||||0.0038|TWO_SIDED|95.0|3.3132|16.8403|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.8403|3.3132|0.0038
71792415|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1875||||0.2257|TWO_SIDED|95.0|-10.989|2.6139|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6139|-10.9890|0.2257
71792416|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8589||||0.8042|TWO_SIDED|95.0|-7.6927|5.975|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9750|-7.6927|0.8042
71792417|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6335||||0.6399|TWO_SIDED|95.0|-8.5177|5.2506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2506|-8.5177|0.6399
71792418|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2763|||<|0.0001|TWO_SIDED|95.0|-23.0228|-9.5229|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.5229|-23.0228|<0.0001
71838644|NCT03865498|143185673|SUPERIORITY||Odds Ratio (OR)|1.021||||0.924|TWO_SIDED|95.0|0.787|1.325||Pearson's Chi-squared test with Yates' continuity correction|Chi-squared, Corrected|||There will be no significant differences in isolated macro-level network structure from Tweets between Hispanic and African American dementia caregiver networks.||1.325|0.787|0.924
71892728|NCT00432809|143306759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892729|NCT00432809|143306759|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71672406|NCT03656068|142863210|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3016.8||||0.8089|TWO_SIDED|95.0|-22996.2|29029.7||p-value for testing mean = 0|t-test, 2 sided|||||29029.7|-22996.2|0.8089
71892730|NCT00432809|143306759|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71892731|NCT00432809|143306760|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71672407|NCT03656068|142863211|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.78||||0.1365|TWO_SIDED|95.0|-4.5|30.06||p-value for testing mean = 0|t-test, 2 sided|||||30.06|-4.50|0.1365
71672408|NCT03656068|142863212|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.954||||0.1322|TWO_SIDED|95.0|-9.525|67.433||p-value for testing mean = 0|t-test, 2 sided|||||67.433|-9.525|0.1322
71672409|NCT03656068|142863213|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.99||||0.1062|TWO_SIDED|95.0|-5.59|53.57|||t-test, 2 sided|p-value for testing mean = 0||||53.57|-5.59|0.1062
71672410|NCT03656068|142863214|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|28.311||||0.0831|TWO_SIDED|95.0|-4.151|60.774||p-value for testing mean = 0|t-test, 2 sided|||||60.774|-4.151|0.0831
71792419|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.9477||||0.0002|TWO_SIDED|95.0|-19.7374|-6.158|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.1580|-19.7374|0.0002
71792420|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7223||||0.0001|TWO_SIDED|95.0|-20.572|-6.8727|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.8727|-20.5720|0.0001
71792421|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2643|||<|0.0001|TWO_SIDED|95.0|-20.9226|-7.606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.6060|-20.9226|<0.0001
71792422|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9356||||0.0016|TWO_SIDED|95.0|-17.6548|-4.2165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.2165|-17.6548|0.0016
71792423|NCT00975481|143083822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7103||||0.0008|TWO_SIDED|95.0|-18.5055|-4.9151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.9151|-18.5055|0.0008
71792424|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.009|||<|0.0001|TWO_SIDED|95.0|13.7265|34.2916|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.2916|13.7265|<0.0001
71792425|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.4156|||<|0.0001|TWO_SIDED|95.0|19.116|39.7151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||39.7151|19.1160|<0.0001
71792426|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3979||||0.2239|TWO_SIDED|95.0|-16.7479|3.9521|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.9521|-16.7479|0.2239
71792427|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1396||||0.4326|TWO_SIDED|95.0|-14.5328|6.2526|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.2526|-14.5328|0.4326
71672411|NCT03656068|142863215|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|32.72||||0.0543|TWO_SIDED|95.0|-0.69|66.13||p-value for testing mean = 0|t-test, 2 sided|||||66.13|-0.69|0.0543
71672412|NCT03656068|142863216|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.056||||0.6325|TWO_SIDED|95.0|-0.185|0.298||p-value for testing mean = 0|t-test, 2 sided|||||0.298|-0.185|0.6325
71672413|NCT03656068|142863217|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.46||||0.6925|TWO_SIDED|95.0|-1.94|2.87||p-value for testing mean = 0|t-test, 2 sided|||||2.87|-1.94|0.6925
71672414|NCT03656068|142863218|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.161||||0.2733|TWO_SIDED|95.0|-0.14|0.462|||t-test, 2 sided|||||0.462|-0.140|0.2733
71672415|NCT03656068|142863219|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.47||||0.3288|TWO_SIDED|95.0|-1.63|4.56||p-value for testing mean = 0|t-test, 2 sided|||||4.56|-1.63|0.3288
71672416|NCT03656068|142863220|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.649||||0.9271|TWO_SIDED|95.0|-121.923|133.22||p-value for testing mean = 0|t-test, 2 sided|||||133.220|-121.923|0.9271
71792428|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7283||||0.7447|TWO_SIDED|95.0|-12.195|8.7383|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7383|-12.1950|0.7447
71792429|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.4069|||<|0.0001|TWO_SIDED|95.0|-40.6795|-20.1343|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1343|-40.6795|<0.0001
71792430|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.1487|||<|0.0001|TWO_SIDED|95.0|-38.4812|-17.8161|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8161|-38.4812|<0.0001
71792431|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.7374|||<|0.0001|TWO_SIDED|95.0|-36.1651|-15.3096|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.3096|-36.1651|<0.0001
71792432|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.8134|||<|0.0001|TWO_SIDED|95.0|-45.9257|-25.7012|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-25.7012|-45.9257|<0.0001
71792433|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.5552|||<|0.0001|TWO_SIDED|95.0|-43.7675|-23.3429|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-23.3429|-43.7675|<0.0001
71672417|NCT03656068|142863221|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.89||||0.9244|TWO_SIDED|95.0|-18.58|20.37||p-value for testing mean = 0|t-test, 2 sided|||||20.37|-18.58|0.9244
71672418|NCT03656068|142863222|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-30.244||||0.7288|TWO_SIDED|95.0|-211.93|151.441||p-value for testing mean = 0|t-test, 2 sided|||||151.441|-211.930|0.7288
71672419|NCT03656068|142863223|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.34||||0.7824|TWO_SIDED|95.0|-21.85|28.52||p-value for testing mean = 0|t-test, 2 sided|||||28.52|-21.85|0.7824
71792434|NCT00975481|143083823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.1439|||<|0.0001|TWO_SIDED|95.0|-41.4754|-20.8124|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.8124|-41.4754|<0.0001
71792435|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.8779|||<|0.0001|TWO_SIDED|95.0|19.5658|30.1899|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.1899|19.5658|<0.0001
71792436|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.9857|||<|0.0001|TWO_SIDED|95.0|20.667|31.3043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||31.3043|20.6670|<0.0001
71838645|NCT03865498|143185674|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|0.628|||<|0.0001|TWO_SIDED|95.0|0.513|0.742|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for African American dementia caregiver networks.||0.742|0.513|<0.0001
71892732|NCT00432809|143306760|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
71892733|NCT00432809|143306760|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||||||0.004
71672420|NCT03656068|142863224|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-47.629||||0.6448|TWO_SIDED|95.0|-260.433|165.176||p-value for testing mean = 0|t-test, 2 sided|||||165.176|-260.433|0.6448
71672421|NCT03656068|142863225|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.38||||0.9806|TWO_SIDED|95.0|-32.04|32.8||p-value for testing mean = 0|t-test, 2 sided|||||32.80|-32.04|0.9806
71672422|NCT03656068|142863226|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-113.616||||0.3256|TWO_SIDED|95.0|-351.124|123.891||p-value for testing mean = 0|t-test, 2 sided|||||123.891|-351.124|0.3256
71672423|NCT03656068|142863227|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|8.78||||0.6582|TWO_SIDED|95.0|-32.52|50.09||p-value for testing mean = 0|t-test, 2 sided|||||50.09|-32.52|0.6582
71792437|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0544||||0.4489|TWO_SIDED|95.0|-3.2911|7.3998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.3998|-3.2911|0.4489
71792438|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5743||||0.8329|TWO_SIDED|95.0|-4.7941|5.9427|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9427|-4.7941|0.8329
71792439|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6863||||0.5387|TWO_SIDED|95.0|-3.7203|7.0929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.0929|-3.7203|0.5387
71792440|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8235|||<|0.0001|TWO_SIDED|95.0|-28.1283|-17.5187|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.5187|-28.1283|<0.0001
71792441|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.3036|||<|0.0001|TWO_SIDED|95.0|-29.64|-18.9672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9672|-29.6400|<0.0001
71672424|NCT03656068|142863228|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2438||||0.5459|TWO_SIDED|95.0|-1.0847|0.5972||p-value for testing mean = 0|t-test, 2 sided|||||0.5972|-1.0847|0.5459
71672425|NCT03656068|142863229|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|23.91||||0.286|TWO_SIDED|95.0|-22.15|69.97|||t-test, 2 sided|||||69.97|-22.15|0.2860
71672426|NCT03656068|142863230|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2893||||0.4887|TWO_SIDED|95.0|-1.158|0.5794||p-value for testing mean = 0|t-test, 2 sided|||||0.5794|-1.1580|0.4887
71672427|NCT03656068|142863231|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|30.27||||0.361|TWO_SIDED|95.0|-38.21|98.75||p-value for testing mean = 0|t-test, 2 sided|||||98.75|-38.21|0.3610
71672428|NCT03656068|142863232|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.63||||0.4945|TWO_SIDED|95.0|-2.51|1.26||p-value for testing mean = 0|t-test, 2 sided|||||1.26|-2.51|0.4945
71792442|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.1916|||<|0.0001|TWO_SIDED|95.0|-28.5768|-17.8064|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.8064|-28.5768|<0.0001
71792443|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9313|||<|0.0001|TWO_SIDED|95.0|-29.1559|-18.7066|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.7066|-29.1559|<0.0001
71892734|NCT00432809|143306761|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892735|NCT00432809|143306761|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71892736|NCT00432809|143306761|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
71892737|NCT00432809|143306762|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892738|NCT00432809|143306762|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892739|NCT00432809|143306762|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared|||||||0.20
71672429|NCT03656068|142863233|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.99||||0.8191|TWO_SIDED|95.0|-9.94|7.95||p-value for testing mean = 0|t-test, 2 sided|||||7.95|-9.94|0.8191
71672430|NCT03656068|142863234|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-3.22||||0.0243|TWO_SIDED|95.0|-5.96|-0.47||p-value for testing mean = 0|t-test, 2 sided|||||-0.47|-5.96|0.0243
71672431|NCT03656068|142863235|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-9.94||||0.0493|TWO_SIDED|95.0|-19.84|-0.04||p-value for testing mean = 0|t-test, 2 sided|||||-0.04|-19.84|0.0493
71672432|NCT03656068|142863236|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.6||||0.3066|TWO_SIDED|95.0|-0.59|1.79||p-value for testing mean = 0|t-test, 2 sided|||||1.79|-0.59|0.3066
71672433|NCT03656068|142863237|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.4||||0.2671|TWO_SIDED|95.0|-2.82|9.63||p-value for testing mean = 0|t-test, 2 sided|||||9.63|-2.82|0.2671
71672434|NCT03656068|142863238|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.11||||0.8241|TWO_SIDED|95.0|-0.94|1.16||p-value for testing mean = 0|t-test, 2 sided|||||1.16|-0.94|0.8241
71672435|NCT03656068|142863239|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|1.1||||0.7587|TWO_SIDED|95.0|-6.37|8.57||p-value for testing mean = 0|t-test, 2 sided|||||8.57|-6.37|0.7587
71792444|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4114|||<|0.0001|TWO_SIDED|95.0|-30.6869|-20.1358|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1358|-30.6869|<0.0001
71792445|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2994|||<|0.0001|TWO_SIDED|95.0|-29.6361|-18.9626|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-18.9626|-29.6361|<0.0001
71792446|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4301||||0.5349|TWO_SIDED|95.0|-5.9725|3.1123|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.1123|-5.9725|0.5349
71792447|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1367||||0.0001|TWO_SIDED|95.0|-13.6684|-4.605|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.6050|-13.6684|0.0001
71838646|NCT03865498|143185674|SUPERIORITY|Pre-post mean difference|Mean Difference (Final Values)|1.41|||<|0.0001|TWO_SIDED|95.0|1.189|1.631|||a paired t-test|||Hypothesis: There will be significant pre/post-intervention differences in emotional valence score detected from Tweets for Hispanic dementia caregiver networks.||1.631|1.189|<0.0001
71672436|NCT03656068|142863240|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.567||||0.3784|TWO_SIDED|95.0|-1.88|0.746||p-value for testing mean = 0|t-test, 2 sided|||||0.746|-1.880|0.3784
71672437|NCT03656068|142863241|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-4.64||||0.3526|TWO_SIDED|95.0|-14.8|5.53||p-value for testing mean = 0|t-test, 2 sided|||||5.53|-14.80|0.3526
71672438|NCT03656068|142863242|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.098||||0.9218|TWO_SIDED|95.0|-1.978|2.173||p-value for testing mean = 0|t-test, 2 sided|||||2.173|-1.978|0.9218
71672439|NCT03656068|142863243|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|0.15||||0.9833|TWO_SIDED|95.0|-14.71|15.01||p-value for testing mean = 0|t-test, 2 sided|||||15.01|-14.71|0.9833
71672440|NCT03656068|142863244|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|12.68||||0.3957|TWO_SIDED|95.0|-17.79|43.16||p-value for testing mean = 0|t-test, 2 sided|||||43.16|-17.79|0.3957
71672441|NCT03656068|142863245|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|3.81||||0.344|TWO_SIDED|95.0|-4.39|12.01||p-value for testing mean = 0|t-test, 2 sided|||||12.01|-4.39|0.3440
71672442|NCT03656068|142863246|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.22||||0.0607|TWO_SIDED|95.0|-0.77|31.21||p-value for testing mean = 0|t-test, 2 sided|||||31.21|-0.77|0.0607
71672443|NCT03656068|142863247|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|5.83||||0.0644|TWO_SIDED|95.0|-0.39|12.05||p-value for testing mean = 0|t-test, 2 sided|||||12.05|-0.39|0.0644
71672444|NCT03656068|142863248|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.3665||||0.0487|TWO_SIDED|95.0|-0.7306|-0.0023||p-value for testing mean = 0|t-test, 2 sided|||||-0.0023|-0.7306|0.0487
71672445|NCT03656068|142863249|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|16.64||||0.5919|TWO_SIDED|95.0|-47.25|80.54||p-value for testing mean = 0|t-test, 2 sided|||||80.54|-47.25|0.5919
71672446|NCT03656068|142863250|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.2679||||0.1272|TWO_SIDED|95.0|-0.634|0.0983||p-value for testing mean = 0|t-test, 2 sided|||||0.0983|-0.6340|0.1272
71838647|NCT03865498|143185674|SUPERIORITY||Mean Difference (Final Values)|0.039||||0.6|TWO_SIDED|95.0|-0.186|0.107|||t-test, 2 sided|||There will be no significant differences in emotional valence score detected from Tweets between Hispanic and African American dementia caregiver networks.||0.107|-0.186|0.600
71672447|NCT03656068|142863251|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|15.02||||0.5881|TWO_SIDED|95.0|-47.55|77.59||p-value for testing mean = 0|t-test, 2 sided|||||77.59|-47.55|0.5881
71672448|NCT03656068|142863252|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.18||||0.1458|TWO_SIDED|95.0|-0.42|0.07|||t-test, 2 sided|||||0.07|-0.42|0.1458
71672449|NCT03656068|142863253|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-11.53||||0.1495|TWO_SIDED|95.0|-27.61|4.54||p-value for testing mean = 0|t-test, 2 sided|||||4.54|-27.61|0.1495
71672450|NCT03656068|142863254|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-0.12||||0.3174|TWO_SIDED|95.0|-0.4|0.15||p-value for testing mean = 0|t-test, 2 sided|||||0.15|-0.40|0.3174
71672451|NCT03656068|142863255|OTHER|Student's T-test was used for statistical inference.|Mean Difference (Net)|-8.02||||0.242|TWO_SIDED|95.0|-22.86|6.82||p-value for testing mean = 0|t-test, 2 sided|||||6.82|-22.86|0.2420
71792448|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3357||||0.5637|TWO_SIDED|95.0|-3.2244|5.8958|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.8958|-3.2244|0.5637
71892740|NCT00432809|143306763|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Chi-squared|||||||0.48
71892741|NCT00432809|143306763|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Chi-squared|||||||0.46
71672452|NCT00162981|142863259|SUPERIORITY_OR_OTHER||||||<|0.0182||95.0|||||1-sided Wilcoxon signed rank test|1-sided Wilcoxon signed rank test was used to assess the difference from baseline.||||||<0.0182
71672453|NCT00162981|142863259|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|1-sided Wilcoxon signed rank test|||||||0.0001
71792449|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4065||||0.8612|TWO_SIDED|95.0|-4.1779|4.9909|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.9909|-4.1779|0.8612
71792450|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9175||||0.6954|TWO_SIDED|95.0|-3.7022|5.5373|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.5373|-3.7022|0.6954
71792451|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7658||||0.2287|TWO_SIDED|95.0|-1.7552|7.2868|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.2868|-1.7552|0.2287
71792452|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8366||||0.4267|TWO_SIDED|95.0|-2.7158|6.389|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.3890|-2.7158|0.4267
71792453|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3476||||0.314|TWO_SIDED|95.0|-2.2429|6.9381|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.9381|-2.2429|0.3140
71792454|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4724|||<|0.0001|TWO_SIDED|95.0|5.9992|14.9456|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.9456|5.9992|<0.0001
71792455|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.5432|||<|0.0001|TWO_SIDED|95.0|5.032|14.0544|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.0544|5.0320|<0.0001
71892742|NCT00432809|143306763|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71672454|NCT00162981|142863262|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.|||||<|0.0001||95.0|||||1-sided Wilcoxon Rank-Sum Test|1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.||||||<0.0001
71892743|NCT00432809|143306764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71672455|NCT00300235|142863264|SUPERIORITY_OR_OTHER||proportion of subjects|35.2||||||95.0|32.5|37.9||||||This was a survey designed to estimate prevalence, no formal comparisons between age or genotype groups were performed.||37.9|32.5|
71672456|NCT00455403|142863272|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.7279|TWO_SIDED|||||"Applies to row Title year 1"|Mixed Models Analysis||"applies to row title year 1"|||||0.7279
71672457|NCT00502242|142863359|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.228||||0.0002|TWO_SIDED|95.0|0.099|0.528||2-sided p-value; alpha equals (=) 0.05|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.528|0.099|0.0002
71672458|NCT00502242|142863360|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.425||||0.0031|TWO_SIDED|95.0|0.237|0.763||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata|||0.763|0.237|0.0031
71892744|NCT00432809|143306764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892745|NCT00432809|143306764|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
71672459|NCT00502242|142863361|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
71892746|NCT00432809|143306765|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892747|NCT00432809|143306765|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71892748|NCT00432809|143306765|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Chi-squared|||||||0.03
71892749|NCT02371629|143306766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033|STANDARD_ERROR_OF_MEAN|0.0169||0.051|TWO_SIDED|95.0|0.0|0.066|||Mixed model for repeated measure (MMRM)|||||0.066|0.000|0.051
71892750|NCT00805207|143306781|OTHER|||||||0.85|||||||t-test, 2 sided|||||||0.85
71892751|NCT00805207|143306781|OTHER|||||||0.7|||||||t-test, 2 sided|||||||0.70
71672460|NCT00502242|142863361|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.074
71672461|NCT00502242|142863362|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.093
71672462|NCT00502242|142863362|SUPERIORITY_OR_OTHER|||||||0.219|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.219
71792456|NCT00975481|143083824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0542|||<|0.0001|TWO_SIDED|95.0|5.494|14.6144|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||14.6144|5.4940|<0.0001
71792457|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4728|||<|0.0001|TWO_SIDED|95.0|9.4718|19.4737|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.4737|9.4718|<0.0001
71792458|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7284|||<|0.0001|TWO_SIDED|95.0|14.7131|24.7437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||24.7437|14.7131|<0.0001
71792459|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2088||||0.9348|TWO_SIDED|95.0|-4.8289|5.2466|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.2466|-4.8289|0.9348
71892752|NCT00805207|143306781|OTHER|||||||0.88||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.88
71672463|NCT00502242|142863363|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||0.002
71672464|NCT00502242|142863363|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.121
71672465|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.16|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
71672466|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.36|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
71672467|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.0098|TWO_SIDED|95.0|0.76|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 3, Ramipril versus (vs.) Placebo||0.96|0.76|0.0098
71792460|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7271||||0.5009|TWO_SIDED|95.0|-6.7841|3.3299|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3299|-6.7841|0.5009
71672468|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.18|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Ramipril||||
71672469|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 4, Placebo||||
71838648|NCT05486078|143185740|OTHER|Repeated measures ANOVA||||||0.001|||||||ANOVA|||Hip abduction strength was analyzed using repeated measures ANOVA. The assumption of sphericity was tested and Bonferroni correction was applied for pairwise comparisons. A p-value \< 0.001 was considered statistically significant.||||0.001
71838649|NCT05486078|143185741|OTHER|McNemar Exact Test|||||<|0.0001||||||P-value derived from McNemar exact test comparing binary outcome (improved vs. unchanged). Statistical significance threshold set at p \< 0.05.|McNemar|McNemar Exact Test||MRI improvement was assessed using paired evaluation of inflammatory signs (edema) at baseline and Week 24. McNemar exact test was used for within-subject categorical comparison.||||< 0.0001
71838650|NCT05486078|143185742|OTHER|Friedman Test Within-group||||||0.992|||||||Friedman Test Within-group|||Analgesic use (units/week) was analyzed over time using the Friedman test for repeated measures. No significant variation across follow-up visits was found.||||0.992
71838651|NCT05590403|143185744|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (\<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.09|0.83|
71672470|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.78||||0.0003|TWO_SIDED|95.0|0.68|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 4, Ramipril vs. Placebo||0.89|0.68|0.0003
71672471|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Ramipirl||||
71672472|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.61|||||TWO_SIDED||||||||Adjusted for baseline|Change from baseline at Week 8, Placebo||||
71672473|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0016|TWO_SIDED|95.0|0.68|0.91||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.91|0.68|0.0016
71672474|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.34|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
71792461|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3325||||0.8975|TWO_SIDED|95.0|-5.4245|4.7595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.7595|-5.4245|0.8975
71792462|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.264|||<|0.0001|TWO_SIDED|95.0|-19.266|-9.2619|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.2619|-19.2660|<0.0001
71792463|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1999|||<|0.0001|TWO_SIDED|95.0|-21.2294|-11.1704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-11.1704|-21.2294|<0.0001
71792464|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8053|||<|0.0001|TWO_SIDED|95.0|-19.8822|-9.7283|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.7283|-19.8822|<0.0001
71792465|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5195|||<|0.0001|TWO_SIDED|95.0|-24.4361|-14.603|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.6030|-24.4361|<0.0001
71792466|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4555|||<|0.0001|TWO_SIDED|95.0|-26.423|-16.488|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.4880|-26.4230|<0.0001
71838652|NCT05590403|143185745|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-2.65|||||TWO_SIDED|95.0|-8.54|3.28|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||3.28|-8.54|
71838653|NCT05590403|143185746|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.89|||||TWO_SIDED|95.0|0.79|1.02|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-HA-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||1.02|0.79|
71892753|NCT00805207|143306781|OTHER|||||||0.26||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.26
71672475|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.63|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
71892754|NCT00805207|143306781|OTHER|||||||0.98||||||P value is the group by treatment interaction from the ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA||||||0.98
71892755|NCT00805207|143306782|OTHER|||||||0.31|||||||t-test, 2 sided|||||||0.31
71892756|NCT00805207|143306782|OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
71892757|NCT00805207|143306782|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
71892758|NCT00805207|143306782|OTHER|||||||0.87|||||||ANCOVA|||||||0.87
71892759|NCT00805207|143306782|OTHER|||||||0.57|||||||ANCOVA|||||||0.57
71672476|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.82||||0.0165|TWO_SIDED|95.0|0.7|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.96|0.70|0.0165
71892760|NCT00805207|143306783|OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
71892761|NCT00805207|143306783|OTHER||||||<|0.05|||||||ANCOVA|||||||<0.05
71892762|NCT00805207|143306783|OTHER|||||||0.53|||||||ANCOVA|||||||0.53
71792467|NCT00975481|143083825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0609|||<|0.0001|TWO_SIDED|95.0|-25.0872|-15.0345|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.0345|-25.0872|<0.0001
71792468|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1634|||<|0.0001|TWO_SIDED|95.0|1.9014|4.4254|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.4254|1.9014|<0.0001
71792469|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6706|||<|0.0001|TWO_SIDED|95.0|3.4066|5.9346|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.9346|3.4066|<0.0001
71792470|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478||||0.8184|TWO_SIDED|95.0|-1.1217|1.4173|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4173|-1.1217|0.8184
71792471|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2211||||0.7324|TWO_SIDED|95.0|-1.054|1.4963|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.4963|-1.0540|0.7324
71792472|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0946||||0.8844|TWO_SIDED|95.0|-1.1898|1.3791|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3791|-1.1898|0.8844
71792473|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0156|||<|0.0001|TWO_SIDED|95.0|-4.2754|-1.7558|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7558|-4.2754|<0.0001
71792474|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9423|||<|0.0001|TWO_SIDED|95.0|-4.2101|-1.6745|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.6745|-4.2101|<0.0001
71792475|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0688|||<|0.0001|TWO_SIDED|95.0|-4.3484|-1.7891|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.7891|-4.3484|<0.0001
71792476|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5228|||<|0.0001|TWO_SIDED|95.0|-5.7651|-3.2805|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2805|-5.7651|<0.0001
71792477|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4495|||<|0.0001|TWO_SIDED|95.0|-5.7031|-3.1959|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1959|-5.7031|<0.0001
71792478|NCT00975481|143083826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.576|||<|0.0001|TWO_SIDED|95.0|-5.8438|-3.3081|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.3081|-5.8438|<0.0001
71792479|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0798|||<|0.0001|TWO_SIDED|95.0|34.0453|58.1142|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||58.1142|34.0453|<0.0001
71672477|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.48|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
71792480|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.8771|||<|0.0001|TWO_SIDED|95.0|37.8247|61.9295|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.9295|37.8247|<0.0001
71792481|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5797||||0.9248|TWO_SIDED|95.0|-12.6918|11.5325|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.5325|-12.6918|0.9248
71792482|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3632||||0.5857|TWO_SIDED|95.0|-15.5264|8.8|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.8000|-15.5264|0.5857
71792483|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4225||||0.4768|TWO_SIDED|95.0|-7.827|16.6719|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.6719|-7.8270|0.4768
71792484|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.6594|||<|0.0001|TWO_SIDED|95.0|-58.6804|-34.6385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.6385|-58.6804|<0.0001
71792485|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.443|||<|0.0001|TWO_SIDED|95.0|-61.5346|-37.3514|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.3514|-61.5346|<0.0001
71792486|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6573|||<|0.0001|TWO_SIDED|95.0|-53.86|-29.4546|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.4546|-53.8600|<0.0001
71792487|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.4567|||<|0.0001|TWO_SIDED|95.0|-62.2925|-38.621|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.6210|-62.2925|<0.0001
71792488|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.2403|||<|0.0001|TWO_SIDED|95.0|-65.1923|-41.2882|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-41.2882|-65.1923|<0.0001
71672478|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.78|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
71792489|NCT00975481|143083827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.4546|||<|0.0001|TWO_SIDED|95.0|-57.5459|-33.3633|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-33.3633|-57.5459|<0.0001
71792490|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.845|||<|0.0001|TWO_SIDED|95.0|34.6464|59.0436|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.0436|34.6464|<0.0001
71792491|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5013|||<|0.0001|TWO_SIDED|95.0|45.3036|69.6991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.6991|45.3036|<0.0001
71892763|NCT00805207|143306783|OTHER|||||||0.23|||||||ANCOVA|||||||0.23
71892764|NCT00805207|143306784|OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
71792492|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0913||||0.4129|TWO_SIDED|95.0|-17.3421|7.1595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||7.1595|-17.3421|0.4129
71792493|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1893||||0.8488|TWO_SIDED|95.0|-13.4954|11.1168|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1168|-13.4954|0.8488
71792494|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1995||||0.4086|TWO_SIDED|95.0|-7.1963|17.5954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||17.5954|-7.1963|0.4086
71792495|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.9363|||<|0.0001|TWO_SIDED|95.0|-64.1108|-39.7618|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-39.7618|-64.1108|<0.0001
71792496|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.0343|||<|0.0001|TWO_SIDED|95.0|-60.2801|-35.7885|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7885|-60.2801|<0.0001
71792497|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.6455|||<|0.0001|TWO_SIDED|95.0|-53.9964|-29.2946|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-29.2946|-53.9964|<0.0001
71792498|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.5926|||<|0.0001|TWO_SIDED|95.0|-74.5881|-50.5971|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-50.5971|-74.5881|<0.0001
71792499|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.6906|||<|0.0001|TWO_SIDED|95.0|-70.7965|-46.5847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-46.5847|-70.7965|<0.0001
71792500|NCT00975481|143083828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.3018|||<|0.0001|TWO_SIDED|95.0|-64.5427|-40.0609|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.0609|-64.5427|<0.0001
71792501|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4604||||0.0016|TWO_SIDED|95.0|6.321|26.5998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||26.5998|6.3210|0.0016
71792502|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.9971|||<|0.0001|TWO_SIDED|95.0|17.8247|38.1696|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||38.1696|17.8247|<0.0001
71792503|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1425||||0.8254|TWO_SIDED|95.0|-11.3591|9.0742|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.0742|-11.3591|0.8254
71838654|NCT05590403|143185747|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-3.95|||||TWO_SIDED|95.0|-10.39|2.53|||||The comparison is done using the difference of SRR (OA-RSV -Adults-HA-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.||2.53|-10.39|
71792504|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.747||||0.8858|TWO_SIDED|95.0|-9.5075|11.0015|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.0015|-9.5075|0.8858
71792505|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4279||||0.5128|TWO_SIDED|95.0|-6.8972|13.7529|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||13.7529|-6.8972|0.5128
71792506|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6028||||0.0008|TWO_SIDED|95.0|-27.7485|-7.4572|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-7.4572|-27.7485|0.0008
71792507|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7134||||0.0028|TWO_SIDED|95.0|-25.9136|-5.5132|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.5132|-25.9136|0.0028
71792508|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0325||||0.0135|TWO_SIDED|95.0|-23.3295|-2.7355|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7355|-23.3295|0.0135
71792509|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.1396|||<|0.0001|TWO_SIDED|95.0|-39.1071|-19.1721|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.1721|-39.1071|<0.0001
71792510|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.2502|||<|0.0001|TWO_SIDED|95.0|-37.3224|-17.178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-17.1780|-37.3224|<0.0001
71792511|NCT00975481|143083829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5693|||<|0.0001|TWO_SIDED|95.0|-34.7614|-14.3772|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.3772|-34.7614|<0.0001
71838655|NCT05590403|143185748|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.96|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.96|0.73|
71792512|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2535||||0.0005|TWO_SIDED|95.0|0.5623|1.9446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.9446|0.5623|0.0005
71838656|NCT05590403|143185749|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-6.67|||||TWO_SIDED|95.0|-12.26|-1.12|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.12|-12.26|
71838657|NCT05590403|143185750|NON_INFERIORITY|Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is \<1.5 at 1 month post RSVPreF3 OA vaccine administration.|GMT Ratio|0.8|||||TWO_SIDED|95.0|0.71|0.91|||||The comparison is done using the group ratio of adjusted GMT (OA-RSV/Adults-AIR-RSV) (ANCOVA model applied to the log10- transformed titers). The ANCOVA model included the group as fixed effects and the pre-dose log-10 titer as covariate|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||0.91|0.71|
71892765|NCT00805207|143306785|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71892766|NCT00805207|143306785|OTHER||||||<|0.01||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|||||||<0.01
71792513|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.501|||<|0.0001|TWO_SIDED|95.0|2.8073|4.1948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.1948|2.8073|<0.0001
71792514|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3418||||0.3347|TWO_SIDED|95.0|-0.3559|1.0396|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0396|-0.3559|0.3347
71792515|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3208||||0.3678|TWO_SIDED|95.0|-0.3808|1.0225|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.0225|-0.3808|0.3678
71792516|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036||||0.9197|TWO_SIDED|95.0|-0.6686|0.7406|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7406|-0.6686|0.9197
71792517|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9117||||0.0099|TWO_SIDED|95.0|-1.6013|-0.222|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2220|-1.6013|0.0099
71792518|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9326||||0.0088|TWO_SIDED|95.0|-1.6269|-0.2384|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2384|-1.6269|0.0088
71792519|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2175||||0.0008|TWO_SIDED|95.0|-1.9171|-0.5178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.5178|-1.9171|0.0008
71792520|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1592|||<|0.0001|TWO_SIDED|95.0|-3.838|-2.4804|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4804|-3.8380|<0.0001
71838658|NCT05590403|143185751|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is \<10%, at 1 month post RSVPreF3 OA vaccine administration.|Difference in percentage|-7.31|||||TWO_SIDED|95.0|-13.52|-1.09|||||The comparison is done using the difference of SRR (OA-RSV -Adults-AIR-RSV)|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.||-1.09|-13.52|
71792521|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1802|||<|0.0001|TWO_SIDED|95.0|-3.8656|-2.4947|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.4947|-3.8656|<0.0001
71792522|NCT00975481|143083830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.465|||<|0.0001|TWO_SIDED|95.0|-4.1583|-2.7717|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.7717|-4.1583|<0.0001
71838659|NCT03701399|143185779|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7581|TWO_SIDED|95.0|-0.47|0.34|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country, baseline score as a covariate|All SCA participants||0.34|-0.47|0.7581
71838660|NCT03701399|143185779|SUPERIORITY||Least square mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.28||0.045|TWO_SIDED|95.0|-1.11|-0.01|||Mixed Models Analysis||Model based summary statistics were from a mixed model with repeated measures, including fixed effects for treatment, randomization stratum (SCA genotype group), visit, treatment-by-visit interaction, and country.|SCA3 genotype participants||-0.01|-1.11|0.0450
71838661|NCT02132936|143185822|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55|||<|0.001|TWO_SIDED|95.0|1.46|4.46|||Mantel Haenszel|||"Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing PGA values."||4.46|1.46|<0.001
71792523|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2943|||<|0.0001|TWO_SIDED|95.0|4.0783|6.5102|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||6.5102|4.0783|<0.0001
71792524|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8983|||<|0.0001|TWO_SIDED|95.0|5.6799|8.1167|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.1167|5.6799|<0.0001
71792525|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6545||||0.2917|TWO_SIDED|95.0|-0.5676|1.8767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.8767|-0.5676|0.2917
71792526|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8489||||0.1738|TWO_SIDED|95.0|-0.3784|2.0763|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.0763|-0.3784|0.1738
71792527|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9372||||0.1373|TWO_SIDED|95.0|-0.3024|2.1767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.1767|-0.3024|0.1373
71792528|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6397|||<|0.0001|TWO_SIDED|95.0|-5.8537|-3.4257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.4257|-5.8537|<0.0001
71792529|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4453|||<|0.0001|TWO_SIDED|95.0|-5.6662|-3.2244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.2244|-5.6662|<0.0001
71792530|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3571|||<|0.0001|TWO_SIDED|95.0|-5.5887|-3.1255|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-3.1255|-5.5887|<0.0001
71672479|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.83||||0.0264|TWO_SIDED|95.0|0.7|0.98||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.98|0.70|0.0264
71792531|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2437|||<|0.0001|TWO_SIDED|95.0|-7.4397|-5.0477|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-5.0477|-7.4397|<0.0001
71792532|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0493|||<|0.0001|TWO_SIDED|95.0|-7.2568|-4.8419|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.8419|-7.2568|<0.0001
71792533|NCT00975481|143083831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9611|||<|0.0001|TWO_SIDED|95.0|-7.1812|-4.741|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-4.7410|-7.1812|<0.0001
71892767|NCT00805207|143306785|OTHER|||||||0.96||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|||||||0.96
71892768|NCT00805207|143306785|OTHER||||||<|0.05||||||P value is the group by treatment interaction from the ANOVA|ANOVA|||||||<0.05
71892769|NCT00805207|143306785|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
71892770|NCT00805207|143306785|OTHER||||||<|0.01|||||||Tukey test|||||||<0.01
71892771|NCT00805207|143306785|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
71892772|NCT00805207|143306785|OTHER||||||>|0.1|||||||Tukey test|||||||>0.10
71792534|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.6205|||<|0.0001|TWO_SIDED|95.0|-33.1192|-20.1219|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-20.1219|-33.1192|<0.0001
71792535|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.5724|||<|0.0001|TWO_SIDED|95.0|-39.1073|-26.0375|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.0375|-39.1073|<0.0001
71792536|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8966||||0.5685|TWO_SIDED|95.0|-4.6607|8.454|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.4540|-4.6607|0.5685
71792537|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5761||||0.2848|TWO_SIDED|95.0|-10.159|3.0068|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.0068|-10.1590|0.2848
71792538|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1754||||0.344|TWO_SIDED|95.0|-9.7855|3.4347|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.4347|-9.7855|0.3440
71792539|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5172|||<|0.0001|TWO_SIDED|95.0|22.0454|34.989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||34.9890|22.0454|<0.0001
71792540|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0445|||<|0.0001|TWO_SIDED|95.0|16.5383|29.5506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||29.5506|16.5383|<0.0001
71792541|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4452|||<|0.0001|TWO_SIDED|95.0|16.8772|30.0131|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||30.0131|16.8772|<0.0001
71792542|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.469|||<|0.0001|TWO_SIDED|95.0|28.1136|40.8244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||40.8244|28.1136|<0.0001
71792543|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9963|||<|0.0001|TWO_SIDED|95.0|22.5734|35.4192|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.4192|22.5734|<0.0001
71838662|NCT02132936|143185823|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18|||=|0.001|TWO_SIDED|95.0|1.37|3.47|||Mantel Haenszel|||"Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing data."||3.47|1.37|=0.001
71792544|NCT00975481|143083832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.397|||<|0.0001|TWO_SIDED|95.0|22.8946|35.8994|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||35.8994|22.8946|<0.0001
71838663|NCT02132936|143185824|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71838664|NCT02132936|143185825|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||<0.001
71792545|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.6044|||<|0.0001|TWO_SIDED|95.0|33.4091|59.7996|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||59.7996|33.4091|<0.0001
71672480|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
71672481|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.82|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
71672482|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.79||||0.0062|TWO_SIDED|95.0|0.66|0.93||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||0.93|0.66|0.0062
71672483|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.4|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
71792546|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7222|||<|0.0001|TWO_SIDED|95.0|37.5038|63.9407|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||63.9407|37.5038|<0.0001
71792547|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6987||||0.9174|TWO_SIDED|95.0|-13.9815|12.584|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.5840|-13.9815|0.9174
71792548|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5629||||0.5002|TWO_SIDED|95.0|-17.9006|8.7749|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||8.7749|-17.9006|0.5002
71792549|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3982||||0.3482|TWO_SIDED|95.0|-7.0337|19.8301|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||19.8301|-7.0337|0.3482
71792550|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.3031|||<|0.0001|TWO_SIDED|95.0|-60.4869|-34.1193|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-34.1193|-60.4869|<0.0001
71672484|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
71672485|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.0341|TWO_SIDED|95.0|0.72|0.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||0.99|0.72|0.0341
71792551|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.1672|||<|0.0001|TWO_SIDED|95.0|-64.4276|-37.9069|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-37.9069|-64.4276|<0.0001
71792552|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.2062|||<|0.0001|TWO_SIDED|95.0|-53.589|-26.8234|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.8234|-53.5890|<0.0001
71792553|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.421|||<|0.0001|TWO_SIDED|95.0|-64.3974|-38.4445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-38.4445|-64.3974|<0.0001
71838665|NCT02132936|143185826|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.33|TWO_SIDED||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.||||=0.33
71672486|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.56|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
71672487|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.86|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
71792554|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2851|||<|0.0001|TWO_SIDED|95.0|-68.3904|-42.1798|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-42.1798|-68.3904|<0.0001
71792555|NCT00975481|143083833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.3241|||<|0.0001|TWO_SIDED|95.0|-57.5825|-31.0656|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.0656|-57.5825|<0.0001
71792556|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.3823|||<|0.0001|TWO_SIDED|95.0|-62.1244|-30.6401|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI was obtained from the model.||-30.6401|-62.1244|<0.0001
71792557|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.5199|||<|0.0001|TWO_SIDED|95.0|-67.2633|-35.7765|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.7765|-67.2633|<0.0001
71792558|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0366||||0.4524|TWO_SIDED|95.0|-9.7924|21.8657|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.8657|-9.7924|0.4524
71792559|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4423||||0.762|TWO_SIDED|95.0|-13.4599|18.3446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.3446|-13.4599|0.7620
71792560|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1573||||0.9846|TWO_SIDED|95.0|-15.8609|16.1754|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||16.1754|-15.8609|0.9846
71792561|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.4189|||<|0.0001|TWO_SIDED|95.0|36.7157|68.1221|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||68.1221|36.7157|<0.0001
71792562|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.8246|||<|0.0001|TWO_SIDED|95.0|33.0228|64.6264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||64.6264|33.0228|<0.0001
71792563|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.5395|||<|0.0001|TWO_SIDED|95.0|30.5968|62.4823|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||62.4823|30.5968|<0.0001
71792564|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|57.5565|||<|0.0001|TWO_SIDED|95.0|42.0679|73.0451|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||73.0451|42.0679|<0.0001
71792565|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.9622|||<|0.0001|TWO_SIDED|95.0|38.3293|69.5952|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||69.5952|38.3293|<0.0001
71838666|NCT02561585|143185827|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.97|TWO_SIDED|95.0|-12.05|11.65||t-test in a baseline adjusted linear model|t-test, 2 sided|t-test, 2 sided on a 5% level||||11.65|-12.05|0.97
71838667|NCT03134196|143185841|SUPERIORITY||Hazard Ratio (HR)|0.78|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.5|1.06||||||||1.06|0.5|
71838668|NCT03134196|143185842|SUPERIORITY||Hazard Ratio (HR)|0.74|STANDARD_DEVIATION|0.04|||TWO_SIDED|95.0|0.56|0.99||||||||0.99|0.56|
71672488|NCT00502242|142863364|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.06|TWO_SIDED|95.0|0.7|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.01|0.70|0.0600
71792566|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.6772|||<|0.0001|TWO_SIDED|95.0|35.866|67.4884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||67.4884|35.8660|<0.0001
71838669|NCT04295798|143185886|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to gait speed from baseline to immediately post intervention.||||0.02
71838670|NCT04295798|143185887|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.02|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway speed from baseline to immediately post intervention.||||0.02
71672489|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.46|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril||||
71792567|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.4454||||0.0003|TWO_SIDED|95.0|17.7051|57.1857|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||57.1857|17.7051|0.0003
71792568|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.6714|||<|0.0001|TWO_SIDED|95.0|22.2888|61.054|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||61.0540|22.2888|<0.0001
71792569|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7583||||0.0744|TWO_SIDED|95.0|-37.2956|1.7789|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7789|-37.2956|0.0744
71792570|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5551||||0.3458|TWO_SIDED|95.0|-29.5573|10.4471|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||10.4471|-29.5573|0.3458
71792571|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.792||||0.9375|TWO_SIDED|95.0|-19.1777|20.7616|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||20.7616|-19.1777|0.9375
71792572|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.2037|||<|0.0001|TWO_SIDED|95.0|-74.8113|-35.5961|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-35.5961|-74.8113|<0.0001
71792573|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.0005|||<|0.0001|TWO_SIDED|95.0|-67.002|-26.9989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-26.9989|-67.0020|<0.0001
71672490|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.05|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo||||
71677259|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0591||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Itchy Eyes||||0.0591
71792574|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6534||||0.0004|TWO_SIDED|95.0|-56.7246|-16.5822|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-16.5822|-56.7246|0.0004
71792575|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-59.4297|||<|0.0001|TWO_SIDED|95.0|-78.5162|-40.3433|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-40.3433|-78.5162|<0.0001
71792576|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.2265|||<|0.0001|TWO_SIDED|95.0|-70.8131|-31.6399|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-31.6399|-70.8131|<0.0001
71792577|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8794||||0.0001|TWO_SIDED|95.0|-60.4726|-21.2862|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-21.2862|-60.4726|0.0001
71792578|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5197||||0.0102|TWO_SIDED|95.0|5.7096|41.3298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.3298|5.7096|0.0102
71792579|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.7321||||0.0021|TWO_SIDED|95.0|10.3632|45.1011|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||45.1011|10.3632|0.0021
71792580|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7334||||0.5935|TWO_SIDED|95.0|-22.2807|12.814|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||12.8140|-22.2807|0.5935
71792581|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5486||||0.6945|TWO_SIDED|95.0|-14.3397|21.437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||21.4370|-14.3397|0.6945
71792582|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2936||||0.4177|TWO_SIDED|95.0|-10.4975|25.0847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||25.0847|-10.4975|0.4177
71792583|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.2531||||0.0019|TWO_SIDED|95.0|-45.802|-10.7042|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.7042|-45.8020|0.0019
71792584|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9711||||0.0299|TWO_SIDED|95.0|-37.9541|-1.988|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.9880|-37.9541|0.0299
71672491|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.71||||0.0034|TWO_SIDED|95.0|0.57|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 3, Ramipril vs. Placebo||0.89|0.57|0.0034
71672492|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.43|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Ramipril||||
71672493|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.37|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 4, Placebo||||
71672494|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.6|||<|0.0001|TWO_SIDED|95.0|0.47|0.76||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 4, Ramipril vs. Placebo||0.76|0.47|<0.0001
71792585|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2261||||0.0759|TWO_SIDED|95.0|-34.1785|1.7264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.7264|-34.1785|0.0759
71792586|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4655||||0.0002|TWO_SIDED|95.0|-49.2278|-15.7032|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.7032|-49.2278|0.0002
71792587|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1835||||0.0069|TWO_SIDED|95.0|-41.5832|-6.7838|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.7838|-41.5832|0.0069
71792588|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4385||||0.0222|TWO_SIDED|95.0|-37.8861|-2.991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.9910|-37.8861|0.0222
71792589|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.589||||0.0002|TWO_SIDED|95.0|12.0126|37.1654|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||37.1654|12.0126|0.0002
71672495|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.67|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Ramipril||||
71672496|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.74|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 8, Placebo||||
71672497|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.61||||0.0002|TWO_SIDED|95.0|0.47|0.79||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo||0.79|0.47|0.0002
71672498|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|1.91|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril||||
71672499|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo||||
71672500|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.65||||0.0032|TWO_SIDED|95.0|0.49|0.87||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo||0.87|0.49|0.0032
71672501|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.33|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril||||
71672502|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo||||
71672503|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.69||||0.013|TWO_SIDED|95.0|0.51|0.92||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo||0.92|0.51|0.0130
71672504|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.5|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril||||
71792590|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.11|||<|0.0001|TWO_SIDED|95.0|16.4903|41.7298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.7298|16.4903|<0.0001
71792591|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6428||||0.6809|TWO_SIDED|95.0|-10.0309|15.3165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||15.3165|-10.0309|0.6809
71792592|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3215||||0.6067|TWO_SIDED|95.0|-16.0415|9.3985|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||9.3985|-16.0415|0.6067
71792593|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4722||||0.3999|TWO_SIDED|95.0|-7.335|18.2795|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||18.2795|-7.3350|0.3999
71792594|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.9461||||0.0007|TWO_SIDED|95.0|-34.5327|-9.3596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-9.3596|-34.5327|0.0007
71792595|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9105|||<|0.0001|TWO_SIDED|95.0|-40.564|-15.257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-15.2570|-40.5640|<0.0001
71792596|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1168||||0.0036|TWO_SIDED|95.0|-31.8907|-6.3428|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-6.3428|-31.8907|0.0036
71792597|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.4672|||<|0.0001|TWO_SIDED|95.0|-38.8298|-14.1046|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-14.1046|-38.8298|<0.0001
71792598|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.4315|||<|0.0001|TWO_SIDED|95.0|-44.925|-19.938|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-19.9380|-44.9250|<0.0001
71792599|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.6378||||0.0003|TWO_SIDED|95.0|-36.2802|-10.9954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-10.9954|-36.2802|0.0003
71792600|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6675||||0.9728|TWO_SIDED|95.0|-39.708|41.043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||41.0430|-39.7080|0.9728
71792601|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.7977||||0.0246|TWO_SIDED|95.0|6.1059|79.4894|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||79.4894|6.1059|0.0246
71792602|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5411||||0.7068|TWO_SIDED|95.0|-33.785|48.8672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||48.8672|-33.7850|0.7068
71672505|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.39|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo||||
71792603|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7069||||0.5492|TWO_SIDED|95.0|-26.0358|47.4496|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||47.4496|-26.0358|0.5492
71792604|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1248||||0.5899|TWO_SIDED|95.0|-31.3098|53.5595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||53.5595|-31.3098|0.5899
71792605|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8736||||0.6998|TWO_SIDED|95.0|-29.8691|43.6163|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||43.6163|-29.8691|0.6998
71792606|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0394||||0.6187|TWO_SIDED|95.0|-31.4818|51.5606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||51.5606|-31.4818|0.6187
71792607|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4573||||0.5863|TWO_SIDED|95.0|-29.0355|49.9502|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||49.9502|-29.0355|0.5863
71838671|NCT04295798|143185888|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.04|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to stride time variability from baseline to immediately post intervention.||||0.04
71838672|NCT04295798|143185889|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.56|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task gait speed from baseline to immediately post intervention.||||0.56
71838673|NCT04295798|143185890|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.07|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task gait speed from baseline to immediately post intervention.||||0.07
71838674|NCT04295798|143185891|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.74|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task stride time variability from baseline to immediately post intervention.||||0.74
71892773|NCT02469246|143306786|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.|Difference in Percentages|-3.8||||0.15|TWO_SIDED|95.002|-8.9|1.1|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||1.1|-8.9|0.15
71672506|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.74||||0.0577|TWO_SIDED|95.0|0.54|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo||1.01|0.54|0.0577
71672507|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.52|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril||||
71672508|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.27|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo||||
71792608|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.2566||||0.0832|TWO_SIDED|95.0|-75.608|5.0948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||5.0948|-75.6080|0.0832
71672509|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.77||||0.1146|TWO_SIDED|95.0|0.56|1.07||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo||1.07|0.56|0.1146
71672510|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|2.92|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril||||
71672511|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Fold Change|3.45|||||TWO_SIDED||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo||||
71672512|NCT00502242|142863365|SUPERIORITY_OR_OTHER||Treatment Ratio|0.85||||0.3496|TWO_SIDED|95.0|0.6|1.2||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo||1.20|0.60|0.3496
71672513|NCT00502242|142863366|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion||||1.0000
71792609|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.0907||||0.0827|TWO_SIDED|95.0|-68.7519|4.5704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||4.5704|-68.7519|0.0827
71792610|NCT00975481|143083834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.6728||||0.1386|TWO_SIDED|95.0|-74.5352|11.1895|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||11.1895|-74.5352|0.1386
71792611|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3637||||0.1691|TWO_SIDED|95.0|-0.1566|0.884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8840|-0.1566|0.1691
71672514|NCT00502242|142863366|SUPERIORITY_OR_OTHER|||||||0.1115|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion||||0.1115
71672515|NCT00502242|142863367|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.26||0.4933|TWO_SIDED|95.0|-3.33|1.61||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 12||1.61|-3.33|0.4933
71672516|NCT00502242|142863367|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|1.45||0.0888|TWO_SIDED|95.0|-0.38|5.33||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 24||5.33|-0.38|0.0888
71672517|NCT00502242|142863367|SUPERIORITY_OR_OTHER||Adjusted LS Mean Difference|2.12|STANDARD_ERROR_OF_MEAN|1.46||0.1475|TWO_SIDED|95.0|-0.75|4.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate|Adjusted for baseline|Change from Baseline at Week 52||4.99|-0.75|0.1475
71672518|NCT00502242|142863368|SUPERIORITY_OR_OTHER||Treatment Ratio|0.84||||0.1167|TWO_SIDED|95.0|0.68|1.04||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 24||1.04|0.68|0.1167
71672519|NCT00502242|142863368|SUPERIORITY_OR_OTHER||Treatment Ratio|1.04||||0.7519|TWO_SIDED|95.0|0.82|1.31||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 52||1.31|0.82|0.7519
71672520|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low DBP ≤50 mmHg||||0.470
71672521|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High DBP ≥110 mmHg||||0.220
71672522|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low SBP: ≤90 mmHg||||0.470
71672523|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High SBP: ≥180 mmHg||||1.000
71672524|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low DBP ≤50 mmHg||||0.725
71672525|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High DBP ≥110 mmHg||||0.227
71672526|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low SBP: ≤90 mmHg||||1.000
71792612|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8444||||0.0017|TWO_SIDED|95.0|0.3238|1.365|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||1.3650|0.3238|0.0017
71792613|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2093||||0.4305|TWO_SIDED|95.0|-0.3141|0.7327|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.7327|-0.3141|0.4305
71792614|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1206||||0.6517|TWO_SIDED|95.0|-0.4064|0.6476|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.6476|-0.4064|0.6517
71792615|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0374||||0.8892|TWO_SIDED|95.0|-0.5666|0.4919|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.4919|-0.5666|0.8892
71792616|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1544||||0.5576|TWO_SIDED|95.0|-0.6737|0.3649|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.3649|-0.6737|0.5576
71792617|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2431||||0.3594|TWO_SIDED|95.0|-0.7658|0.2796|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2796|-0.7658|0.3594
71792618|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4011||||0.1355|TWO_SIDED|95.0|-0.9291|0.127|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.1270|-0.9291|0.1355
71792619|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6351||||0.0153|TWO_SIDED|95.0|-1.1466|-0.1236|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.1236|-1.1466|0.0153
71792620|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7238||||0.0065|TWO_SIDED|95.0|-1.2418|-0.2059|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.2059|-1.2418|0.0065
71792621|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8818||||0.0011|TWO_SIDED|95.0|-1.4042|-0.3594|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-0.3594|-1.4042|0.0011
71792622|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1614|||<|0.0001|TWO_SIDED|95.0|-2.9373|-1.3856|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-1.3856|-2.9373|<0.0001
71792623|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0336|||<|0.0001|TWO_SIDED|95.0|-3.8085|-2.2587|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||-2.2587|-3.8085|<0.0001
71792624|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2791||||0.4804|TWO_SIDED|95.0|-1.0586|0.5004|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.5004|-1.0586|0.4804
71792625|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024||||0.9519|TWO_SIDED|95.0|-0.7608|0.8087|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.8087|-0.7608|0.9519
71792626|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497||||0.2152|TWO_SIDED|95.0|-1.286|0.2921|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||0.2921|-1.2860|0.2152
71792627|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8824|||<|0.0001|TWO_SIDED|95.0|1.1094|2.6553|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.6553|1.1094|<0.0001
71792628|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1854|||<|0.0001|TWO_SIDED|95.0|1.407|2.9638|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.9638|1.4070|<0.0001
71792629|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6645|||<|0.0001|TWO_SIDED|95.0|0.8786|2.4503|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||2.4503|0.8786|<0.0001
71792630|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7545|||<|0.0001|TWO_SIDED|95.0|1.9912|3.5179|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.5179|1.9912|<0.0001
71792631|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0576|||<|0.0001|TWO_SIDED|95.0|2.2858|3.8294|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.8294|2.2858|<0.0001
71792632|NCT00975481|143083835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5366|||<|0.0001|TWO_SIDED|95.0|1.7578|3.3155|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.||3.3155|1.7578|<0.0001
71892774|NCT02469246|143306787|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|-6.3||||0.042|TWO_SIDED|95.0|-12.3|-0.3|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||-0.3|-12.3|0.042
71892775|NCT02469246|143306788|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.1||||0.45|TWO_SIDED|95.002|-1.0|3.5|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||3.5|-1.0|0.45
71892776|NCT02469246|143306789|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.4||||0.34|TWO_SIDED|95.0|-1.0|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-1.0|0.34
71792633|NCT01895855|143083848|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|90.3|||||ONE_SIDED|95.1|62.7||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||62.7|
71792634|NCT01895855|143083849|SUPERIORITY|The lower, two sided 95% confidence bound on protective efficacy must be \>/= 30%.|Vaccine Efficacy|79.5|||||ONE_SIDED|95.1|49.9||||||Confidence intervals for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.|||49.9|
71792635|NCT01895855|143083850|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0073
71792636|NCT01895855|143083851|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenge 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
71792637|NCT01895855|143083852|SUPERIORITY||Vaccine Efficacy|84.5|||||TWO_SIDED|95.0|67.0|100.0|||||Confidence interval for the protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||100.0|67.0|
71792638|NCT01895855|143083853|SUPERIORITY||Vaccine Efficacy|50.8|||||TWO_SIDED|95.0|33.6|66.8|||||Confidence interval for protective vaccine efficacy (PE) estimates were calculated using the method of Farrington and Manning (Farrington 1990).|33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||66.8|33.6|
71792639|NCT01895855|143083854|SUPERIORITY|||||||0.0025|||||||Fisher Exact|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0025
71792640|NCT01895855|143083855|SUPERIORITY|||||||0.0159|||||||Fisher Exact|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||0.0159
71792641|NCT01895855|143083856|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
71792642|NCT01895855|143083857|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
71792643|NCT01895855|143083858|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||35 participants were challenged 10 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
71792644|NCT01895855|143083859|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||33 participants were challenged 90 days after receiving PXVX0200. 66 participants were challenged either 10 days or 90 days after receiving placebo.||||<0.0001
71672527|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High SBP: ≥180 mmHg||||0.106
71672528|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, High DBP ≥110 mmHg||||1.000
71672529|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, Low SBP: ≤90 mmHg||||1.000
71792645|NCT00944450|143083882|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)|Geometric Mean Ratio|1.05||||||90.0|1.02|1.07||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.07|1.02|
71792646|NCT00944450|143083883|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)|Geometric Mean Ratio|1.07||||||90.0|0.94|1.22||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)||1.22|0.94|
71838675|NCT04295798|143185892|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.33|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task stride time variability from baseline to immediately post intervention.||||0.33
71838676|NCT04295798|143185893|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.16|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task cost to standing postural sway area from baseline to immediately post intervention.||||0.16
71792647|NCT02448654|143083897|SUPERIORITY|||||||0.18||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.18
71792648|NCT02448654|143083898|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.03
71792649|NCT02448654|143083899|SUPERIORITY|||||||0.037||||||The a priori threshold for statistical significance was p\<0.05.|ANOVA|||||||0.037
71792650|NCT00853723|143083900|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline by day 15 in all three arms.|Kruskal-Wallis|||||||<0.0005
71792651|NCT00853723|143083901|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups.|Kruskal-Wallis|The threshold for stasistical significance was p=0.05||||||<0.05
71792652|NCT00853723|143083902|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline at Day 60 and at Day 90 for the PTH group and at day 90 for the PTHrP 400 and PTHrP 600 groups .|Kruskal-Wallis|||||||<0.05
71672530|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low DBP ≤50 mmHg||||0.475
71672531|NCT00502242|142863369|SUPERIORITY_OR_OTHER|||||||0.475|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low SBP: ≤90 mmHg||||0.475
71672532|NCT00502242|142863371|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||1.000
71672533|NCT00502242|142863371|SUPERIORITY_OR_OTHER|||||||0.626|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.626
71672534|NCT00502242|142863371|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.297
71838677|NCT04295798|143185894|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.52|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway speed from baseline to immediately post intervention.||||0.52
71838678|NCT04295798|143185895|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.01|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway speed from baseline to immediately post intervention.||||0.01
71672535|NCT00502242|142863371|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.356
71672536|NCT00502242|142863372|SUPERIORITY_OR_OTHER|||||||0.064|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.064
71672537|NCT00502242|142863372|SUPERIORITY_OR_OTHER|||||||0.069|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.069
71672538|NCT00502242|142863372|SUPERIORITY_OR_OTHER|||||||0.752|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.752
71672539|NCT00502242|142863372|SUPERIORITY_OR_OTHER|||||||0.261|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.261
71672540|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.381|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 4||||0.381
71672541|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.956|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 12||||0.956
71672542|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in adjusted means|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.903|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 24||||0.903
71672543|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.503|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 52||||0.503
71672544|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.451|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 4||||0.451
71672545|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.919|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 12||||0.919
71672546|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.02|STANDARD_ERROR_OF_MEAN|0.04||0.637|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 24||||0.637
71672547|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.229|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 52||||0.229
71672548|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.766|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 4||||0.766
71672549|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 12||||0.217
71672550|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.457|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 24||||0.457
71672551|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.26|STANDARD_ERROR_OF_MEAN|0.13||0.041|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 52||||0.041
71672552|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.044|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 4||||0.044
71672553|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.18|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 12||||0.180
71672554|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.19|STANDARD_ERROR_OF_MEAN|0.17||0.264|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 24||||0.264
71672555|NCT00502242|142863373|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.408|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 52||||0.408
71792653|NCT00853723|143083903|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in PTHrP 400 and 600 groups.|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
71792654|NCT00853723|143083904|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in the PTHrP 400 group|Kruskal-Wallis|The threshold for stastistical significance was p=0.05||||||<0.05
71792655|NCT00853723|143083905|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical signifcance was p=0.05||||||>0.05
71792656|NCT00853723|143083906|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||>0.05
71792657|NCT00853723|143083907|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value corresponds to change from baseline at Day 15 and 30 in the PTHrP 400 group and at Day 15 in the PTHrP 600 group|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.0005
71838679|NCT04295798|143185896|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.39|||||||ANOVA|||We hypothesized no significant effect of intervention type on absolute change in single task postural sway area from baseline to immediately post intervention||||0.39
71672556|NCT00502242|142863374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.487||||0.0732|TWO_SIDED|95.0|0.887|6.978||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank||Hazard ratio was based on the Cox proportional hazards model.|||6.978|0.887|0.0732
71672557|NCT00502242|142863376|SUPERIORITY_OR_OTHER|||||||0.7165|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL, AM BCAR||||0.7165
71672558|NCT00502242|142863376|SUPERIORITY_OR_OTHER|||||||0.4795|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL (On-Therapy), AM BCAR||||0.4795
71672559|NCT00502242|142863377|SUPERIORITY_OR_OTHER|||||||0.4773|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Week 52||||0.4773
71672560|NCT00502242|142863378|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.124
71672561|NCT00502242|142863378|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.410
71672562|NCT00502242|142863378|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.423
71672563|NCT00502242|142863378|SUPERIORITY_OR_OTHER|||||||0.297|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.297
71672564|NCT00502242|142863379|SUPERIORITY_OR_OTHER|||||||0.726|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.726
71672565|NCT00502242|142863380|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||1.000
71672566|NCT00502242|142863381|SUPERIORITY_OR_OTHER|||||||0.753|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||||||0.753
71672567|NCT00502242|142863382|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline||||0.224
71672568|NCT00502242|142863382|SUPERIORITY_OR_OTHER|||||||0.179|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL||||0.179
71672569|NCT00502242|142863382|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy||||0.604
71672570|NCT00502242|142863382|SUPERIORITY_OR_OTHER|||||||0.486|TWO_SIDED|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy||||0.486
71672571|NCT02104219|142863423|SUPERIORITY_OR_OTHER|||||||0.0755|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median RGI-C score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Pairs of radiographs were centrally evaluated by 3 independent, blinded pediatric radiologists trained in the assessment of the skeletal manifestations of HPP. The mean RGI-C score across the 3 radiologists was calculated and served as the patient's RGI-C score for a specific time point||||0.0755
71792658|NCT00853723|143083908|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to PTH group on Day 60 compared to the PTHrP 400|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05||||||<0.05
71792659|NCT00853723|143083908|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the PTH group on Day 30 compared to the PTHrP 400 group and Day 60 compared to the PTHRp 600 group|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
71792660|NCT00853723|143083908|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005|TWO_SIDED|||||The reported p-value correspond to the PTH group on Day 15 compared to the PTHrP 400 group and Day 15 and 30 compared to the PTHrP 600 group.|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.0005
71792661|NCT00853723|143083909|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the increase from baseline to D90 in the PTHrP 400 group.|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.005
71792662|NCT00853723|143083910|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p value corresponds to an increased from baseline at all time points in all Arms/groups as well as to the increase in the in the PTHrP 400 group at Day 60 and 90 compared to the PTHrP 600 and PTH groups .|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05||||||<0.05
71792663|NCT00853723|143083910|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes|||||<|0.005|TWO_SIDED|||||The reported p-value corresponds to the comparison of the PTHrP 400 group at Day 15 to the PTHrP 600 and PTH groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.005
71792664|NCT00853723|143083911|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds to an increase compared to baseline in the PTHrP 600 group at D15 and D30|F-test, one way analysis of variance|The threshold for stastistical significance was p=0.05||||||<0.05
71838680|NCT04295798|143185897|EQUIVALENCE|Model effects included stimulation condition (i.e., gel-tDCS, sponge-tDCS, gel-sham and sponge-sham), time (pre-, post-stimulation), and their interaction. Previous studies showed age, sex, and BMI were associated with one or more metrics of standing or walking and were therefore included as covariates. Tukey's post-hoc testing was used to compare factor means of significant models.||||||0.18|||||||ANOVA|||We hypothesized a significant effect of intervention type on absolute change in dual task postural sway area from baseline to immediately post intervention.||||0.18
71838681|NCT04908722|143185932|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.15|||||TWO_SIDED|97.5|0.926|1.44||||||Group 1 (1 dose) vs Group 3 (1 dose)||1.440|0.926|
71838682|NCT04908722|143185932|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.8||||||97.5|0.641|1.0||||||Group 5 (1 dose) vs Group 3 (1 dose)||1.00|0.641|
71838683|NCT04908722|143185932|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.07|||||TWO_SIDED|97.5|0.844|1.356||||||Group 2 (1 dose) vs Group 3 (1 dose)||1.356|0.844|
71838684|NCT04908722|143185932|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.94|||||TWO_SIDED|97.5|0.742|1.193||||||Group 4 (1 dose) vs Group 3 (1 dose)||1.193|0.742|
71838685|NCT04908722|143185932|NON_INFERIORITY|Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.81|||||TWO_SIDED|97.5|0.648|1.007||||||Group 6 (1 dose) vs Group 3 (1 dose)||1.007|0.648|
71677260|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1818||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Burning Eyes||||0.1818
71792665|NCT00853723|143083911|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.005|TWO_SIDED|||||the reported p-value corresponds to change from baseline in the PTHrP 400 group at Day 15,30, 60 and 90 and the PTH group at day 90.|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.005
71792666|NCT00853723|143083912|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05|TWO_SIDED|||||The reported p-value corresponds the PTH group on Day 15 compared to the PTHrP 400 group and to the PTHrP 600 group at Day 30 and Day 60|Kruskal-Wallis|The threshold for statistical significance was p=0.05||||||<0.05
71792667|NCT00853723|143083912|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.0005|TWO_SIDED|||||Thre reported p-value correspond to the PTH group compared to the PTHrp 600 group at day 15|Kruskal-Wallis|the threshold for statistical significance was p=0.05||||||<0.0005
71792668|NCT03245008|143083932|SUPERIORITY||Least Squares Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.57|-0.86||Adjusted P-value|Mixed Models Analysis|||||-0.86|-1.57|<0.001
71792669|NCT03245008|143083932|SUPERIORITY||Least Squares Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.21||0.103|TWO_SIDED|95.0|-0.76|0.07||Adjusted P-value|Mixed Models Analysis|||||0.07|-0.76|0.103
71792670|NCT03245008|143083933|SUPERIORITY||Least Squares Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.6|-0.92||Adjusted P-value|Mixed Models Analysis|||||-0.92|-1.60|<0.001
71792671|NCT03245008|143083933|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.84|-0.05||||||||-0.05|-0.84|
71792672|NCT01286012|143083943|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71792673|NCT01286012|143083944|SUPERIORITY_OR_OTHER|||||||0.915|||||||Cochran-Mantel-Haenszel|||||||0.915
71792674|NCT01286012|143083945|SUPERIORITY_OR_OTHER|||||||0.6714|||||||Cochran-Mantel-Haenszel|||||||0.6714
71838686|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.53|||||TWO_SIDED|97.5|1.992|3.207||||||Group 1 (2 doses) vs Group 3 (1 dose)||3.207|1.992|
71838687|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.41|||||TWO_SIDED|97.5|1.088|1.815||||||Group 1 (2 doses) vs Group 3 (2 doses)||1.815|1.088|
71838688|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.79|||||TWO_SIDED|97.5|1.408|2.265||||||Group 5 (2 doses) vs Group 3 (1 dose)||2.265|1.408|
71838689|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.769|1.282||||||Group 5 (2 doses) vs Group 3 (2 doses)||1.282|0.769|
71838690|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.37|||||TWO_SIDED|97.5|1.829|3.007||||||Group 2 (2 doses) vs Group 3 (1 dose)||3.007|1.829|
71838691|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.32|||||TWO_SIDED|97.5|1.0|1.739||||||Group 2 (2 doses) vs Group 3 (2 doses)||1.739|1.000|
71838692|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|2.2|||||TWO_SIDED|97.5|1.697|2.841||||||Group 4 (2 doses) vs Group 3 (1 dose)||2.841|1.697|
71838693|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.22|||||TWO_SIDED|97.5|0.928|1.606||||||Group 4 (2 doses) vs Group 3 (2 doses)||1.606|0.928|
71838694|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|1.7|||||TWO_SIDED|97.5|1.348|2.148||||||Group 6 (2 doses) vs Group 3 (1 dose)||2.148|1.348|
71838695|NCT04908722|143185933|NON_INFERIORITY|Testing according to sequential non-inferiority assessment hypothesis. Tested using 97.5% confidence interval approach. The non-inferiority margin was 0.67.|Geometric mean ratio|0.95|||||TWO_SIDED|97.5|0.736|1.217||||||Group 6 (2 doses) vs Group 3 (2 doses)||1.217|0.736|
71792675|NCT01286012|143083946|SUPERIORITY_OR_OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71792676|NCT01286012|143083947|SUPERIORITY_OR_OTHER|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||||||0.361
71838696|NCT02319759|143185943|SUPERIORITY||Percent difference|39.7|||<|0.001|TWO_SIDED|95.0|25.3|54.1|||Cochran-Mantel-Haenszel|||||54.1|25.3|<0.001
71792677|NCT00663052|143083957|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact||Primary endpoint used 95% CI to compare to prespecified target rates for each treatment arm.|With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% \& 68.8%, respectively to reject null hypotheses.||29.88|6.80|0.0015
71792678|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3605|TWO_SIDED|95.0|-3.88|10.16|||Fisher Exact|||Comparison between treatment groups at Week 2||10.16|-3.88|0.3605
71792679|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|17.91||||0.0013|TWO_SIDED|95.0|6.5|29.32|||Fisher Exact|||Comparison between treatment groups at Week 4||29.32|6.50|0.0013
71792680|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|19.6||||0.0011|TWO_SIDED|95.0|7.51|31.7|||Fisher Exact|||Comparison between treatment groups at Week 8||31.70|7.51|0.0011
71792681|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|20.09|||<|0.0001|TWO_SIDED|95.0|9.77|30.4|||Fisher Exact|||Comparison between treatment groups at Week 12||30.40|9.77|<.0001
71792682|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|14.38||||0.001|TWO_SIDED|95.0|5.39|23.37|||Fisher Exact|||Comparison between treatment groups at Week 16||23.37|5.39|0.0010
71792683|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|10.75||||0.0087|TWO_SIDED|95.0|2.35|19.16|||Fisher Exact|||Comparison between treatment groups at Week 20||19.16|2.35|0.0087
71792684|NCT00663052|143083958|SUPERIORITY_OR_OTHER||Proportion difference|11.46||||0.0068|TWO_SIDED|95.0|2.77|20.15|||Fisher Exact|||Comparison between treatment groups at Week 24||20.15|2.77|0.0068
71792685|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|1.5||||0.2435|TWO_SIDED|95.0|-1.31|4.32|||Fisher Exact|||Comparison between treatment groups at Week 2||4.32|-1.31|0.2435
71792686|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|1.64||||0.5929|TWO_SIDED|95.0|-4.4|7.67|||Fisher Exact|||Comparison between treatment groups at Week 4||7.67|-4.40|0.5929
71792687|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|13.44||||0.0156|TWO_SIDED|95.0|2.02|24.86|||Fisher Exact|||Comparison between treatment groups at Week 8||24.86|2.02|0.0156
71792688|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|25.18|||<|0.0001|TWO_SIDED|95.0|12.89|37.47|||Fisher Exact|||Comparison between treatment groups at Week 12||37.47|12.89|<.0001
71792689|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|21.84||||0.0003|TWO_SIDED|95.0|9.82|33.85|||Fisher Exact|||Comparison between treatment groups at Week 16||33.85|9.82|0.0003
71792690|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|19.8||||0.0006|TWO_SIDED|95.0|8.23|31.38|||Fisher Exact|||Comparison between treatment groups at Week 20||31.38|8.23|0.0006
71792691|NCT00663052|143083959|SUPERIORITY_OR_OTHER||Proportion difference|18.34||||0.0015|TWO_SIDED|95.0|6.8|29.88|||Fisher Exact|||Comparison between treatment groups at Week 24||29.88|6.80|0.0015
71792692|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was not applicable as the percentage of participants achieving 90% improvement in PASI in both treatment groups were 0%.|Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
71792693|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|0.02||||1|TWO_SIDED|95.0|-2.77|2.81|||Fisher Exact|||Comparison between treatment groups at Week 4||2.81|-2.77|1.0000
71792694|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.2611|TWO_SIDED|95.0|-3.2|11.07|||Fisher Exact|||Comparison between treatment groups at Week 8||11.07|-3.20|0.2611
71792695|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|18.37||||0.0002|TWO_SIDED|95.0|8.3|28.45|||Fisher Exact|||Comparison between treatment groups at Week 12||28.45|8.30|0.0002
71792696|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|17.31||||0.0031|TWO_SIDED|95.0|5.43|29.19|||Fisher Exact|||Comparison between treatment groups at Week 16||29.19|5.43|0.0031
71792697|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|15.92||||0.0081|TWO_SIDED|95.0|3.8|28.04|||Fisher Exact|||Comparison between treatment groups at Week 20||28.04|3.80|0.0081
71792698|NCT00663052|143083960|SUPERIORITY_OR_OTHER||Proportion difference|16.78||||0.0064|TWO_SIDED|95.0|4.46|29.1|||Fisher Exact|||Comparison between treatment groups at Week 24||29.10|4.46|0.0064
71792699|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74||The P-value at Week 2 was to be calculated by Fisher Exact method but was not estimable as the percentage of participants achieving 100% improvement in PASI in both treatment groups were 0%.||||Comparison between treatment groups at Week 2||0.74|-0.74|
71792700|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
71792701|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|-1.46||||0.4983|TWO_SIDED|95.0|-4.21|1.29|||Fisher Exact|||Comparison between treatment groups at Week 8||1.29|-4.21|0.4983
71792702|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|1.57||||0.4957|TWO_SIDED|95.0|-3.23|6.37|||Fisher Exact|||Comparison between treatment groups at Week 12||6.37|-3.23|0.4957
71792703|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|3.14||||0.3115|TWO_SIDED|95.0|-3.24|9.52|||Fisher Exact|||Comparison between treatment groups at Week 16||9.52|-3.24|0.3115
71792704|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|6.99||||0.0773|TWO_SIDED|95.0|-1.13|15.1|||Fisher Exact|||Comparison between treatment groups at Week 20||15.10|-1.13|0.0773
71792705|NCT00663052|143083961|SUPERIORITY_OR_OTHER||Proportion difference|5.53||||0.183|TWO_SIDED|95.0|-2.82|13.87|||Fisher Exact|||Comparison between treatment groups at Week 24||13.87|-2.82|0.1830
71792706|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0103|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.3|-2.3|0.0103
71838697|NCT02319759|143185944|SUPERIORITY||Percentage (%) Difference|66.1|||<|0.001|TWO_SIDED|95.0|53.8|78.4|||Cochran-Mantel-Haenszel|||||78.4|53.8|<0.001
71838698|NCT02319759|143185945|SUPERIORITY||Least Square Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.471|-0.148|||MMRM|MMRM stands for Mixed-effects Model Repeated Measures||||-0.148|-0.471|<0.001
71838699|NCT03131154|143185987|OTHER||Hazard Ratio (HR)|1.129|||||TWO_SIDED|95.0|0.643|1.982|||||Cox proportional hazards model|||1.982|0.643|
71838700|NCT03131154|143185988|OTHER||Hazard Ratio (HR)|2.619|||||TWO_SIDED|95.0|0.989|6.939|||||Cox proportional hazards model|||6.939|0.989|
71838701|NCT06424236|143185989|SUPERIORITY||Least square (LS) mean|-0.1166|STANDARD_DEVIATION|0.29505||0.0117|TWO_SIDED|95.0|-0.206|-0.0272|||Mixed Model for Repeated Measures (MMRM)|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.0272|-0.2060|0.0117
71792707|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.8||||0.0031|TWO_SIDED|95.0|-3.0|-0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.6|-3.0|0.0031
71792708|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.4|-1.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-1.7|-4.4|<0.0001
71792709|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-2.2|-5.0|<0.0001
71792710|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-1.5|-4.0|<0.0001
71792711|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.1||||0.0012|TWO_SIDED|95.0|-3.3|-0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.8|-3.3|0.0012
71792712|NCT00663052|143083962|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0042|TWO_SIDED|95.0|-3.4|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.7|-3.4|0.0042
71792713|NCT00663052|143083963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
71792714|NCT00663052|143083963|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.||||<0.0001
71792715|NCT00663052|143083963|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.||||0.0053
71792716|NCT00663052|143083963|SUPERIORITY_OR_OTHER|||||||0.0432|TWO_SIDED||||||Log Rank|||Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.||||0.0432
71792717|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|0.0|||||TWO_SIDED|95.0|-0.74|0.74|||Fisher Exact|||Comparison between treatment groups at Week 2||0.74|-0.74|
71792718|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|-0.73||||1|TWO_SIDED|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4||1.44|-2.90|1.0000
71792719|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|0.04||||1|TWO_SIDED|95.0|-3.58|3.67|||Fisher Exact|||Comparison between treatment groups at Week 8||3.67|-3.58|1.0000
71792720|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|6.1||||0.0401|TWO_SIDED|95.0|-0.26|12.47|||Fisher Exact|||Comparison between treatment groups at Week 12||12.47|-0.26|0.0401
71792721|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|3.29||||0.4415|TWO_SIDED|95.0|-4.95|11.54|||Fisher Exact|||Comparison between treatment groups at Week 16||11.54|-4.95|0.4415
71792722|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|8.6||||0.0617|TWO_SIDED|95.0|-0.67|17.87|||Fisher Exact|||Comparison between treatment groups at Week 20||17.87|-0.67|0.0617
71838702|NCT06424236|143185989|OTHER||LS mean|-0.4648|STANDARD_DEVIATION|0.46591|<|0.0001|TWO_SIDED|95.0|-0.5971|-0.3326|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.3326|-0.5971|<0.0001
71792723|NCT00663052|143083964|SUPERIORITY_OR_OTHER||Proportion difference|8.64||||0.072|TWO_SIDED|95.0|-0.96|18.24|||Fisher Exact|||Comparison between treatment groups at Week 24||18.24|-0.96|0.0720
71792724|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|-1.45||||0.6223|TWO_SIDED|95.0|-5.07|2.16|||Fisher Exact|||Comparison between treatment groups at Week 2||2.16|-5.07|0.6223
71792725|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|6.21||||0.1|TWO_SIDED|95.0|-1.56|13.98|||Fisher Exact|||Comparison between treatment groups at Week 4||13.98|-1.56|0.1000
71792726|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|15.59||||0.0037|TWO_SIDED|95.0|4.53|26.65|||Fisher Exact|||Comparison between treatment groups at Week 8||26.65|4.53|0.0037
71792727|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|22.04||||0.0004|TWO_SIDED|95.0|9.75|34.33|||Fisher Exact|||Comparison between treatment groups at Week 12||34.33|9.75|0.0004
71792728|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|13.46||||0.0285|TWO_SIDED|95.0|0.94|25.97|||Fisher Exact|||Comparison between treatment groups at Week 16||25.97|0.94|0.0285
71792729|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|15.05||||0.0139|TWO_SIDED|95.0|2.67|27.43|||Fisher Exact|||Comparison between treatment groups at Week 20||27.43|2.67|0.0139
71792730|NCT00663052|143083965|SUPERIORITY_OR_OTHER||Proportion difference|19.56||||0.0012|TWO_SIDED|95.0|7.38|31.74|||Fisher Exact|||Comparison between treatment groups at Week 24||31.74|7.38|0.0012
71792731|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|5.01||||0.3956|TWO_SIDED|95.0|-6.01|16.03|||Fisher Exact|||Comparison between treatment groups at Week 2||16.03|-6.01|0.3956
71792732|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|8.66||||0.1754|TWO_SIDED|95.0|-3.82|21.14|||Fisher Exact|||Comparison between treatment groups at Week 4||21.14|-3.82|0.1754
71792733|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|13.81||||0.0207|TWO_SIDED|95.0|1.9|25.72|||Fisher Exact|||Comparison between treatment groups at Week 8||25.72|1.90|0.0207
71792734|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|19.38|||<|0.0001|TWO_SIDED|95.0|9.23|29.53|||Fisher Exact|||Comparison between treatment groups at Week 12||29.53|9.23|<0.0001
71792735|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|13.54||||0.0044|TWO_SIDED|95.0|3.79|23.29|||Fisher Exact|||Comparison between treatment groups at Week 16||23.29|3.79|0.0044
71792736|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|10.62||||0.0223|TWO_SIDED|95.0|1.11|20.13|||Fisher Exact|||Comparison between treatment groups at Week 20||20.13|1.11|0.0223
71792737|NCT00663052|143083966|SUPERIORITY_OR_OTHER||Proportion difference|11.37||||0.0133|TWO_SIDED|95.0|1.96|20.78|||Fisher Exact|||Comparison between treatment groups at Week 24||20.78|1.96|0.0133
71792738|NCT00663052|143083967|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.||||0.0003
71792739|NCT00663052|143083967|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.||||0.0022
71792740|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0193|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||-0.0|-0.3|0.0193
71792741|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0114|TWO_SIDED|95.0|-0.4|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.4|0.0114
71792742|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.5|0.0006
71792743|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.7|<0.0001
71792744|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0058|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.5|0.0058
71792745|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0018|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.1|-0.6|0.0018
71792746|NCT00663052|143083968|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0009|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.2|-0.6|0.0009
71792747|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.6396|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.6396
71792748|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0074|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0074
71792749|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0007|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.9|0.0007
71792750|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.5|-1.1|<0.0001
71792751|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.004|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.1|-0.8|0.0040
71792752|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.3|-0.9|0.0004
71792753|NCT00663052|143083969|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.1799|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||-0.1|-0.5|0.1799
71792754|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.7757|TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.3|-0.2|0.7757
71792755|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.2112|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||0.1|-0.4|0.2112
71792756|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.5467|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||0.2|-0.3|0.5467
71792757|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.3684|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.1|-0.4|0.3684
71672572|NCT02104219|142863424|SUPERIORITY_OR_OTHER|||||||0.6344|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in height Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented height measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline height. Height measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in height Z-score from Baseline were computed by subtracting baseline height Z-score from post baseline height Z-scores. The post baseline time points were grouped by time intervals.||||0.6344
71672573|NCT02104219|142863425|SUPERIORITY_OR_OTHER|||||||0.452|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether the median change in weight Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented weight measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline weight. Weight measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in weight Z-score from Baseline were computed by subtracting baseline weight Z-score from post baseline weight Z-scores. The post baseline time points were grouped by time intervals.||||0.4520
71672574|NCT02104219|142863426|SUPERIORITY_OR_OTHER|||||||0.4545|TWO_SIDED|||||The p-value is based on a nonparametric sign test used to determine whether change from baseline in the median RSS score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The Baseline x-ray set defined for RGI-C, which was compared with its subsequent x-ray sets, was also used as the Baseline x-ray set for the RSS reading. Changes from Baseline were computed based on this baseline RSS score, and postbaseline time points were grouped by intervals of time from Baseline.||||0.4545
71792758|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||-0.2046|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||0.1|-0.4|-0.2046
71672575|NCT03137160|142863446|SUPERIORITY|||||||1|||||||Fisher Exact|||This is the Investigator Global Assessment comparing the proportion of subjects who achieved a 2 pt reduction at study close (0).||||1
71792759|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.0649|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||0.0|-0.5|0.0649
71792760|NCT00663052|143083970|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8683|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-0.3|0.8683
71792761|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.8898|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.2|-0.3|0.8898
71792762|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.009|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.1|-0.7|0.0090
71792763|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.4||||0.0028|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.2|-0.7|0.0028
71792764|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6||||0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.3|-0.9|0.0001
71792765|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.3|-0.9|<0.0001
71672576|NCT01339260|142863453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.001|TWO_SIDED|95.0|1.16|1.87||If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050|Cochran-Mantel-Haenszel||Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.|The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.||1.87|1.16|0.001
71672577|NCT01339260|142863454|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.047|TWO_SIDED|95.0|1.0|1.87||If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.87|1.0|0.047
71792766|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.5||||0.0016|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-0.8|0.0016
71792767|NCT00663052|143083971|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.0602|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-0.6|0.0602
71792768|NCT00663052|143083974|SUPERIORITY_OR_OTHER||Proportion difference|0.42||||1|TWO_SIDED|95.0|-7.7|8.55|||Fisher Exact|||Comparison between treatment groups at Week 12||8.55|-7.70|1.0000
71792769|NCT00663052|143083974|SUPERIORITY_OR_OTHER||Proportion difference|3.94||||0.4213|TWO_SIDED|95.0|-5.75|13.63|||Fisher Exact|||Comparison between treatment groups at Week 16||13.63|-5.75|0.4213
71792770|NCT00663052|143083974|SUPERIORITY_OR_OTHER||Proportion difference|3.98||||0.4039|TWO_SIDED|95.0|-5.38|13.35|||Fisher Exact|||Comparison between treatment groups at Week 20||13.35|-5.38|0.4039
71792771|NCT00663052|143083974|SUPERIORITY_OR_OTHER||Proportion difference|2.5||||0.6168|TWO_SIDED|95.0|-6.87|11.88|||Fisher Exact|||Comparison between treatment groups at Week 24||11.88|-6.87|0.6168
71792772|NCT00663052|143083975|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.2||||0.862|TWO_SIDED|95.0|-2.8|2.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||||2.3|-2.8|0.8620
71792773|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|5.68||||0.3525|TWO_SIDED|95.0|-6.05|17.4|||Fisher Exact|||Comparison between treatment groups at Week 2||17.40|-6.05|0.3525
71792774|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|14.7||||0.0202|TWO_SIDED|95.0|2.19|27.2|||Fisher Exact|||Comparison between treatment groups at Week 4||27.20|2.19|0.0202
71792775|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|14.41||||0.0178|TWO_SIDED|95.0|2.17|26.64|||Fisher Exact|||Comparison between treatment groups at Week 8||26.64|2.17|0.0178
71792776|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|21.52|||<|0.0001|TWO_SIDED|95.0|11.02|32.03|||Fisher Exact|||Comparison between treatment groups at Week 12||32.03|11.02|<0.0001
71792777|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|10.53||||0.0325|TWO_SIDED|95.0|0.43|20.64|||Fisher Exact|||Comparison between treatment groups at Week 16||20.64|0.43|0.0325
71792778|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|12.04||||0.0129|TWO_SIDED|95.0|2.1|21.97|||Fisher Exact|||Comparison between treatment groups at Week 20||21.97|2.10|0.0129
71792779|NCT00663052|143083976|SUPERIORITY_OR_OTHER||Proportion difference|11.28||||0.0209|TWO_SIDED|95.0|1.26|21.3|||Fisher Exact|||Comparison between treatment groups at Week 24||21.30|1.26|0.0209
71792780|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|12.1||||0.0461|TWO_SIDED|95.0|-0.24|24.44|||Fisher Exact|||Comparison between treatment groups at Week 2||24.44|-0.24|0.0461
71838703|NCT06424236|143185989|OTHER||LS mean|-0.7062|STANDARD_DEVIATION|0.43787|<|0.0001|TWO_SIDED|95.0|-0.8821|-0.5303|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite \[11C\] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-0.5303|-0.8821|<0.0001
71792781|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|8.83||||0.1314|TWO_SIDED|95.0|-2.44|20.1|||Fisher Exact|||Comparison between treatment groups at Week 4||20.10|-2.44|0.1314
71792782|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|11.2||||0.0289|TWO_SIDED|95.0|0.65|21.74|||Fisher Exact|||Comparison between treatment groups at Week 8||21.74|0.65|0.0289
71792783|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|8.52||||0.0433|TWO_SIDED|95.0|-0.04|17.07|||Fisher Exact|||Comparison between treatment groups at Week 12||17.07|-0.04|0.0433
71792784|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|7.06||||0.0902|TWO_SIDED|95.0|-1.32|15.43|||Fisher Exact|||Comparison between treatment groups at Week 16||15.43|-1.32|0.0902
71792785|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|7.79||||0.063|TWO_SIDED|95.0|-0.68|16.26|||Fisher Exact|||Comparison between treatment groups at Week 20||16.26|-0.68|0.0630
71792786|NCT00663052|143083977|SUPERIORITY_OR_OTHER||Proportion difference|7.7||||0.0907|TWO_SIDED|95.0|-1.53|16.93|||Fisher Exact|||Comparison between treatment groups at Week 24||16.93|-1.53|0.0907
71792787|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|3.25||||0.6255|TWO_SIDED|95.0|-9.39|15.9|||Fisher Exact|||Comparison between treatment groups at Week 2||15.90|-9.39|0.6255
71792788|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|9.3||||0.1292|TWO_SIDED|95.0|-2.85|21.45|||Fisher Exact|||Comparison between treatment groups at Week 4||21.45|-2.85|0.1292
71792789|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|11.86||||0.0251|TWO_SIDED|95.0|0.94|22.78|||Fisher Exact|||Comparison between treatment groups at Week 8||22.78|0.94|0.0251
71792790|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|14.16||||0.0055|TWO_SIDED|95.0|3.68|24.64|||Fisher Exact|||Comparison between treatment groups at Week 12||24.64|3.68|0.0055
71792791|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|11.99||||0.0159|TWO_SIDED|95.0|1.78|22.2|||Fisher Exact|||Comparison between treatment groups at Week 16||22.20|1.78|0.0159
71792792|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|9.05||||0.0672|TWO_SIDED|95.0|-1.08|19.18|||Fisher Exact|||Comparison between treatment groups at Week 20||19.18|-1.08|0.0672
71792793|NCT00663052|143083980|SUPERIORITY_OR_OTHER||Proportion difference|10.51||||0.0351|TWO_SIDED|95.0|0.27|20.75|||Fisher Exact|||Comparison between treatment groups at Week 24||20.75|0.27|0.0351
71792794|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|6.24||||0.2283|TWO_SIDED|95.0|-4.11|16.58|||Fisher Exact|||Comparison between treatment groups at Week 2||16.58|-4.11|0.2283
71792795|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|5.49||||0.2326|TWO_SIDED|95.0|-3.68|14.66|||Fisher Exact|||Comparison between treatment groups at Week 4||14.66|-3.68|0.2326
71792796|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 8||18.52|1.47|0.0165
71792797|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|10.0||||0.0165|TWO_SIDED|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 12||18.52|1.47|0.0165
71792798|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|4.85||||0.2536|TWO_SIDED|95.0|-3.46|13.15|||Fisher Exact|||Comparison between treatment groups at Week 16||13.15|-3.46|0.2536
71792799|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|5.6||||0.1761|TWO_SIDED|95.0|-2.59|13.78|||Fisher Exact|||Comparison between treatment groups at Week 20||13.78|-2.59|0.1761
71792800|NCT00663052|143083981|SUPERIORITY_OR_OTHER||Proportion difference|4.01||||0.3943|TWO_SIDED|95.0|-5.18|13.2|||Fisher Exact|||Comparison between treatment groups at Week 24||13.20|-5.18|0.3943
71792801|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.3||||0.5748|TWO_SIDED|95.0|-1.5|0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2||0.8|-1.5|0.5748
71792802|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.2||||0.0471|TWO_SIDED|95.0|-2.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4||-0.0|-2.4|0.0471
71792803|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.0||||0.0025|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8||-0.7|-3.3|0.0025
71792804|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-2.2||||0.0009|TWO_SIDED|95.0|-3.5|-0.9|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||-0.9|-3.5|0.0009
71792805|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.9||||0.0015|TWO_SIDED|95.0|-3.1|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16||-0.7|-3.1|0.0015
71792806|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.5||||0.0197|TWO_SIDED|95.0|-2.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20||-0.2|-2.7|0.0197
71792807|NCT00663052|143083982|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-1.3||||0.0506|TWO_SIDED|95.0|-2.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.0|-2.6|0.0506
71792808|NCT00663052|143083983|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.04||||0.0435|TWO_SIDED|95.0|0.0|0.09|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.09|0.00|0.0435
71792809|NCT00663052|143083983|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.05||||0.0275|TWO_SIDED|95.0|0.01|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.10|0.01|0.0275
71838704|NCT06424236|143185990|SUPERIORITY|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.32||||0.4535|TWO_SIDED|95.0|0.64|2.7|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Asymptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||2.70|0.64|0.4535
71792810|NCT00663052|143083984|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|0.0||||0.9473|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.7|-0.7|0.9473
71792811|NCT00663052|143083984|SUPERIORITY_OR_OTHER||Difference of adjusted mean change|-0.1||||0.8217|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.6|-0.8|0.8217
71792812|NCT00663052|143083985|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.7||||0.0539|TWO_SIDED|95.0|-1.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12||0.0|-1.4|0.0539
71792813|NCT00663052|143083985|SUPERIORITY_OR_OTHER||Difference of Adjusted Mean Change|-0.5||||0.1494|TWO_SIDED|95.0|-1.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24||0.2|-1.3|0.1494
71792814|NCT00663052|143083991|SUPERIORITY_OR_OTHER|||||||0.2139|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2139
71792815|NCT00663052|143083991|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
71792816|NCT00663052|143083993|SUPERIORITY_OR_OTHER|||||||0.2443|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 12||||0.2443
71792817|NCT00663052|143083993|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Comparison between treatment groups at Week 24||||1.0000
71792818|NCT00663052|143083994|SUPERIORITY_OR_OTHER|||||||0.0807|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 12||||0.0807
71792819|NCT00663052|143083994|SUPERIORITY_OR_OTHER|||||||0.1454|TWO_SIDED||||||ANCOVA|||Comparison of treatment groups at Week 24||||0.1454
71792820|NCT05760300|143083995|OTHER||Geometric Least-squares Mean Ratio|84.5|||||TWO_SIDED|90.0|60.1|119.0|||||Parametric (normal theory) analysis of covariance (ANOVA) model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||119|60.1|
71792821|NCT05760300|143083995|OTHER||Geometric Least-squares Mean Ratio|104.0|||||TWO_SIDED|90.0|80.8|133.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||133|80.8|
71792822|NCT05760300|143083996|OTHER||Geometric Least-squares Mean Ratio|106.0|||||TWO_SIDED|90.0|63.6|175.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||175|63.6|
71792823|NCT05760300|143083996|OTHER||Geometric Least-squares Mean Ratio|108.0|||||TWO_SIDED|90.0|77.8|151.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||151|77.8|
71792824|NCT05760300|143083997|OTHER||Geometric Least-squares Mean Ratio|83.8|||||TWO_SIDED|90.0|67.4|104.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||104|67.4|
71792825|NCT05760300|143083997|OTHER||Geometric Least-squares Mean Ratio|100.0|||||TWO_SIDED|90.0|56.2|179.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||179|56.2|
71792826|NCT05760300|143083998|OTHER||Geometric Least-squares Mean Ratio|96.5|||||TWO_SIDED|90.0|65.1|143.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||143|65.1|
71792827|NCT05760300|143083998|OTHER||Geometric Least-squares Mean Ratio|77.8|||||TWO_SIDED|90.0|42.7|142.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|||142|42.7|
71792828|NCT05760300|143084003|OTHER||Geometric Least-squares Mean Ratio|160.0|||||TWO_SIDED|90.0|97.2|263.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||263|97.2|
71792829|NCT05760300|143084003|OTHER||Geometric Least-squares Mean Ratio|65.9|||||TWO_SIDED|90.0|35.0|124.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||124|35.0|
71792830|NCT05760300|143084003|OTHER||Geometric Least-squares Mean Ratio|86.7|||||TWO_SIDED|90.0|53.3|141.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||141|53.3|
71892777|NCT02469246|143306790|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-1.6||||0.62|TWO_SIDED|95.0|-7.4|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||4.2|-7.4|0.62
71892778|NCT02469246|143306791|NON_INFERIORITY|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-5.9||||0.069|TWO_SIDED|95.0|-12.2|0.4|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.||0.4|-12.2|0.069
71792831|NCT05760300|143084003|OTHER||Geometric Least-squares Mean Ratio|72.6|||||TWO_SIDED|90.0|50.4|105.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||105|50.4|
71792832|NCT05760300|143084004|OTHER||Geometric Least-squares Mean Ratio|139.0|||||TWO_SIDED|90.0|87.8|221.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||221|87.8|
71792833|NCT05760300|143084004|OTHER||Geometric Least-squares Mean Ratio|66.8|||||TWO_SIDED|90.0|37.3|120.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||120|37.3|
71792834|NCT05760300|143084004|OTHER||Geometric Least-squares Mean Ratio|85.7|||||TWO_SIDED|90.0|54.5|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.5|
71792835|NCT05760300|143084004|OTHER||Geometric Least-squares Mean Ratio|70.3|||||TWO_SIDED|90.0|49.4|100.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||100|49.4|
71792836|NCT05760300|143084005|OTHER||Geometric Least-squares Mean Ratio|84.2|||||TWO_SIDED|90.0|32.7|217.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||217|32.7|
71792837|NCT05760300|143084005|OTHER||Geometric Least-squares Mean Ratio|58.0|||||TWO_SIDED|90.0|30.1|112.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||112|30.1|
71672578|NCT01339260|142863455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.001|TWO_SIDED|95.0|1.17|1.85||If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.||1.85|1.17|0.001
71672579|NCT03448419|142863464|SUPERIORITY||Median difference (HL-estimate)|-4.0||||0.4236|TWO_SIDED|95.0|-16.0|6.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||6.0|-16.0|0.4236
71672580|NCT03448419|142863465|SUPERIORITY||Median difference (HL-estimate)|3.13||||0.0893|TWO_SIDED|95.0|0.0|7.29|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||7.29|0.00|0.0893
71672581|NCT03448419|142863466|SUPERIORITY||Median Difference (HL-estimate)|0.1||||0.4702|TWO_SIDED|95.0|-0.2|0.4|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||0.40|-0.20|0.4702
71792838|NCT05760300|143084005|OTHER||Geometric Least-squares Mean Ratio|85.6|||||TWO_SIDED|90.0|54.1|135.0|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 1||135|54.1|
71792839|NCT05760300|143084005|OTHER||Geometric Least-squares Mean Ratio|69.6|||||TWO_SIDED|90.0|48.9|99.2|||||Parametric (normal theory) ANOVA model appropriate for a parallel design with renal function group as a fixed effect was fitted to the natural log-transformed values of the multiple dose PK parameter under evaluation.|Day 6||99.2|48.9|
71792840|NCT00877058|143084008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.05|TWO_SIDED|95.0|0.15|0.48|||Chi-squared|||||0.48|0.15|<0.05
71792841|NCT00877058|143084008|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.001|TWO_SIDED|0.05|0.24|0.68|||Chi-squared|||||0.68|0.24|0.001
71792842|NCT00877058|143084009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56|||<|0.05|TWO_SIDED|95.0|0.96|2.52|||Chi-squared|||||2.52|0.96|<0.05
71792843|NCT00877058|143084009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.05|TWO_SIDED|95.0|0.79|2.08|||Chi-squared|||||2.08|0.79|<0.05
71792844|NCT00877058|143084010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.31|0.97|||Chi-squared|||||0.97|0.31|<0.05
71838705|NCT06424236|143185990|OTHER|Recurrent progression was defined as any progression which was either the first increase in CDR-SB above baseline or any progression above the highest preceding post-baseline value identified as a progression, where progression above the preceding value must be observed at 2 consecutive measurements unless the progression occurs at the last measurement.|Hazard Ratio (HR)|1.18||||0.4848|TWO_SIDED|95.0|0.74|1.86|||Regression, Cox|||The time to recurrent progression in CDR - sum of boxes. Baseline Symptomatic Participants: Estimate and confidence interval was based on the Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point.||1.86|0.74|0.4848
71838706|NCT06424236|143185991|OTHER||Hazard Ratio (HR)|0.93||||0.8855|TWO_SIDED|95.0|0.33|2.58|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Asymptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||2.58|0.33|0.8855
71672582|NCT03448419|142863467|SUPERIORITY||Median difference (HL-estimate)|0.0||||0.983|TWO_SIDED|95.0|-9.0|9.0|||Wilcoxon rank test, normal approximation||Empagliflozin vs. Placebo. For estimation of effect, the non-parametric Hodge-Lehman (HL) estimate for the median difference was calculated.|H0: There is no difference between the effect of placebo and the effect of empagliflozin.||9.0|-9.0|0.9830
71672583|NCT03448419|142863468|OTHER||Difference of adjusted means|-0.31||||0.0053|TWO_SIDED|95.0|-0.53|-0.09|||Mixed Model repeated Measures (MMRM)|Covariates: visit-by-treatment interaction, baseline-by-visit interaction. Unstructured covariance structure was used to model within-patient errors.||||-0.09|-0.53|0.0053
71672584|NCT03448419|142863469|OTHER|||||||0.6189|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6189
71672585|NCT03448419|142863470|OTHER|||||||0.6672|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.6672
71672586|NCT03448419|142863471|OTHER|||||||0.5147|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.5147
71672587|NCT03448419|142863472|OTHER|||||||0.863|||||||Cochran-Mantel-Haenszel test|Test on difference in mean treatment scores, based on modified ridit scores.||||||0.8630
71677261|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.4284||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Gritty Eyes||||0.4284
71792845|NCT00877058|143084010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||<|0.05|TWO_SIDED|95.0|0.33|1.02|||Chi-squared|||||1.02|0.33|<0.05
71792846|NCT03628703|143084014|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71792847|NCT04350788|143084019|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for patient.||||0.02
71792848|NCT04350788|143084019|SUPERIORITY|||||||0.25|||||||t-test, 1 sided|||We analyzed program satisfaction between SCP and ESCP by role (patient vs partner). The following result is for partner.||||0.25
71792849|NCT04350788|143084020|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in general domain.||||0.36
71792850|NCT04350788|143084020|SUPERIORITY|||||||0.38|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in content domain.||||0.38
71792851|NCT04350788|143084020|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in navigation domain.||||0.02
71792852|NCT04350788|143084020|SUPERIORITY|||||||0.62|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in general domain.||||0.62
71792853|NCT04350788|143084020|SUPERIORITY|||||||0.65|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in content domain.||||0.65
71792854|NCT04350788|143084020|SUPERIORITY|||||||0.45|||||||t-test, 1 sided|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in navigation domain.||||0.45
71792855|NCT04350788|143084021|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||0.35
71792856|NCT04350788|143084022|SUPERIORITY|||||||0.01|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in urinary domain.||||0.01
71792857|NCT04350788|143084022|SUPERIORITY|||||||0.41|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in bowel domain.||||0.41
71792858|NCT04350788|143084022|SUPERIORITY|||||||0.21|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in sexual domain.||||0.21
71792859|NCT04350788|143084022|SUPERIORITY|||||||0.52|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for patient in hormonal domain.||||0.52
71792860|NCT04350788|143084022|SUPERIORITY|||||||0.79|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in urinary domain.||||0.79
71792861|NCT04350788|143084022|SUPERIORITY|||||||0.84|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in bowel domain.||||0.84
71792862|NCT04350788|143084022|SUPERIORITY|||||||0.82|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in sexual domain.||||0.82
71792863|NCT04350788|143084022|SUPERIORITY|||||||0.33|||||||ANCOVA|||We analyzed this measure between SCP and ESCP by role (patient vs partner) and by domain. The following result is for partner in hormonal domain.||||0.33
71792864|NCT04350788|143084023|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
71792865|NCT04350788|143084023|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
71792866|NCT04350788|143084024|SUPERIORITY|||||||0.05|||||||generalized linear regression|||||||0.05
71792867|NCT04350788|143084025|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
71792868|NCT04350788|143084026|SUPERIORITY|||||||0.29|||||||Mixed Models Analysis|||||||0.29
71838707|NCT06424236|143185991|OTHER||Hazard Ratio (HR)|0.72||||0.4497|TWO_SIDED|95.0|0.3|1.69|||Regression, Cox|||Time to first progression in CDR-Global score. Baseline Symptomatic Participants: Estimate and confidence interval was based on Cox proportional hazards regression model including treatment and baseline estimated years to symptom onset as fixed effects. Time to first progression was defined as time from baseline to first visit where CDR-Global Score was greater than baseline value, where progression must be observed at 2 consecutive measurements unless progression occurs at last measurement.||1.69|0.30|0.4497
71838708|NCT06424236|143185992|SUPERIORITY||LS mean|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.76|TWO_SIDED|95.0|-0.46|0.33|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with compound symmetry covariance matrix.||0.33|-0.46|0.760
71792869|NCT04350788|143084027|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|||||||0.49
71792870|NCT04350788|143084028|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71792871|NCT04350788|143084029|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|||||||0.16
71792872|NCT04350788|143084030|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
71792873|NCT01252940|143084036|NON_INFERIORITY_OR_EQUIVALENCE|A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR - SBR) in the response rate was greater than -12%.|Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.1||||||||9.1|-1.6|
71792874|NCT00483223|143084058|OTHER|||||||0.54|||||||t-test, 2 sided|||H0: no association between expression ratio and response rate Ha: Participants with expression ratio greater than 2 would have higher response rate||||0.54
71792875|NCT03265249|143084092|SUPERIORITY||Median Difference (Final Values)|5.7||||0.8|TWO_SIDED|95.0|-17.5|29.0|||Mixed Models Analysis|||||29|-17.5|0.80
71792876|NCT03054857|143084154|SUPERIORITY||Risk Ratio (RR)|1.532||||0.289|TWO_SIDED|95.0|0.689|3.406|||Chi-squared|||||3.406|0.689|0.289
71792877|NCT03054857|143084155|SUPERIORITY||Risk Ratio (RR)|1.329||||0.636|TWO_SIDED|95.0|0.409|4.319|||Chi-squared|||||4.319|0.409|0.636
71792878|NCT03054857|143084157|SUPERIORITY||Mean Difference (Final Values)|-1.053|STANDARD_DEVIATION|0.792||0.187|TWO_SIDED|95.0|-2.626|0.52|||t-test, 2 sided|||||0.52|-2.626|0.187
71792879|NCT03054857|143084158|SUPERIORITY||Mean Difference (Final Values)|-4.644|STANDARD_DEVIATION|7.606||0.543|TWO_SIDED|95.0|-19.74|10.45|||t-test, 2 sided|||||10.45|-19.74|0.543
71672588|NCT03448419|142863473|OTHER||Adjusted geometric mean ratio|0.91||||0.141|TWO_SIDED|95.0|0.81|1.03|||Mixed Model repeated Measures (MMRM)|Covariates: NT-proBNP-by-visit interaction and visit-by-treatment interaction. Unstructured covariance structure to model within-patient errors.|Adjusted geometric mean ratio \[Empagliflozin/Placebo\] of relative change to baseline.|The endpoint 'relative change from baseline in NT-proBNP at Week 12' (after log-transformation) was evaluated using an MMRM analysis over time with baseline log-transformed NT-proBNP-by-visit interaction and visit-by-treatment interaction as covariates.Unstructured covariance structure was used to model within-patient errors.||1.03|0.81|0.1410
71672589|NCT00630825|142863504|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672590|NCT00630825|142863504|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672591|NCT00630825|142863504|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672592|NCT00630825|142863505|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672593|NCT00630825|142863505|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71792880|NCT02584504|143084170|SUPERIORITY||Least Square (LS) Mean Difference|-39.5|||<|0.0001|TWO_SIDED|97.5|-46.5|-32.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis|Threshold for significance at 0.025 level.|Alirocumab 150 mg Q4W vs. Placebo|Alirocumab 150 mg Q4W group was compared to placebo group using an appropriate contrast statement.||-32.4|-46.5|<0.0001
71792881|NCT02584504|143084170|SUPERIORITY||LS Mean Difference|-65.8|||<|0.0001|TWO_SIDED|97.5|-72.9|-58.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q2W group was compared to placebo group using an appropriate contrast statement.||-58.7|-72.9|<0.0001
71838709|NCT06424236|143185992|OTHER||LS mean|-1.21|STANDARD_ERROR_OF_MEAN|0.715||0.093|TWO_SIDED|95.0|-2.63|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-2.63|0.093
71672594|NCT00630825|142863505|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672595|NCT00630825|142863506|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672596|NCT00630825|142863506|SUPERIORITY_OR_OTHER|||||||0.047||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
71672597|NCT00630825|142863506|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.025
71672598|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672599|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672600|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672601|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672602|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672603|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672604|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672605|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672606|NCT00630825|142863507|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672607|NCT00630825|142863508|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672608|NCT00630825|142863508|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672609|NCT00630825|142863508|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
71672610|NCT00630825|142863508|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.904
71672611|NCT00630825|142863508|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.||||||0.138
71672612|NCT00630825|142863508|SUPERIORITY_OR_OTHER|||||||0.729||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.729
71792882|NCT02584504|143084170|OTHER|Statistical test was not planned because this comparison was for a descriptive purpose.|LS Mean Difference|-26.3|||||TWO_SIDED|95.0|-32.5|-20.0|||||Alirocumab 150 mg Q4W group vs Alirocumab 150 mg Q2W|Alirocumab 150 mg Q4W group was compared to Alirocumab 150 mg Q2W group using an appropriate contrast statement.||-20.0|-32.5|
71792883|NCT02584504|143084171|SUPERIORITY||LS Mean Difference|-40.6|||<|0.0001|TWO_SIDED|97.5|-47.4|-33.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Hierarchical procedure for comparisons of Alirocumab 150 mg Q4W versus Placebo Q2W and Alirocumab 150 mg Q2W versus Placebo Q2W were processed separately.||-33.8|-47.4|<0.0001
71792884|NCT02584504|143084171|SUPERIORITY||LS Mean Difference|-67.4|||<|0.0001|TWO_SIDED|97.5|-74.2|-60.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.5|-74.2|<0.0001
71792885|NCT02584504|143084172|SUPERIORITY||LS Mean Difference|-50.5|||<|0.0001|TWO_SIDED|97.5|-56.6|-44.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-44.5|-56.6|<0.0001
71792886|NCT02584504|143084172|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|97.5|-72.3|-60.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-60.1|-72.3|<0.0001
71792887|NCT02584504|143084173|SUPERIORITY||LS Mean Difference|-51.4|||<|0.0001|TWO_SIDED|97.5|-57.4|-45.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.4|-57.4|<0.0001
71792888|NCT02584504|143084173|SUPERIORITY||LS Mean Difference|-67.3|||<|0.0001|TWO_SIDED|97.5|-73.3|-61.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-61.3|-73.3|<0.0001
71792889|NCT02584504|143084174|SUPERIORITY||LS Mean Difference|-26.2|||<|0.0001|TWO_SIDED|97.5|-32.5|-19.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-19.9|-32.5|<0.0001
71792890|NCT02584504|143084174|SUPERIORITY||LS Mean Difference|-51.9|||<|0.0001|TWO_SIDED|97.5|-58.3|-45.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-45.5|-58.3|<0.0001
71792891|NCT02584504|143084175|SUPERIORITY||LS Mean Difference|-27.2|||<|0.0001|TWO_SIDED|97.5|-33.5|-20.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-20.9|-33.5|<0.0001
71792892|NCT02584504|143084175|SUPERIORITY||LS Mean Difference|-53.4|||<|0.0001|TWO_SIDED|97.5|-59.7|-47.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-47.1|-59.7|<0.0001
71792893|NCT02584504|143084176|SUPERIORITY||LS Mean Difference|-31.3|||<|0.0001|TWO_SIDED|97.5|-37.7|-25.0||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-25.0|-37.7|<0.0001
71792894|NCT02584504|143084176|SUPERIORITY||LS Mean Difference|-56.2|||<|0.0001|TWO_SIDED|97.5|-62.5|-49.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-49.8|-62.5|<0.0001
71792895|NCT02584504|143084177|SUPERIORITY||LS Mean Difference|-32.4|||<|0.0001|TWO_SIDED|97.5|-38.6|-26.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-26.3|-38.6|<0.0001
71792896|NCT02584504|143084177|SUPERIORITY||LS Mean Difference|-57.6|||<|0.0001|TWO_SIDED|97.5|-63.8|-51.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-51.4|-63.8|<0.0001
71792897|NCT02584504|143084178|SUPERIORITY||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|97.5|-27.4|-17.6||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-17.6|-27.4|<0.0001
71892779|NCT02469246|143306792|SUPERIORITY||Difference in LSM|-32.0||||0.026|TWO_SIDED|95.0|-61.0|-4.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-4|-61|0.026
71672613|NCT00630825|142863510|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672614|NCT00630825|142863510|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71792898|NCT02584504|143084178|SUPERIORITY||LS Mean Difference|-41.4|||<|0.0001|TWO_SIDED|97.5|-46.4|-36.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-36.5|-46.4|<0.0001
71792899|NCT02584504|143084179|SUPERIORITY||Odds Ratio (OR)|61.2|||<|0.0001|TWO_SIDED|97.5|13.9|268.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||268.9|13.9|<0.0001
71792900|NCT02584504|143084179|SUPERIORITY||Odds Ratio (OR)|281.4|||<|0.0001|TWO_SIDED|97.5|33.3|2382.2||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||2382.2|33.3|<0.0001
71792901|NCT02584504|143084180|SUPERIORITY||Odds Ratio (OR)|102.8|||<|0.0001|TWO_SIDED|97.5|19.0|556.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||556.8|19.0|<0.0001
71792902|NCT02584504|143084180|SUPERIORITY||Odds Ratio (OR)|500.8|||<|0.0001|TWO_SIDED|97.5|47.9|5230.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||5230.9|47.9|<0.0001
71792903|NCT02584504|143084181|SUPERIORITY||Adjusted Mean Difference|-32.9|||<|0.0001|TWO_SIDED|97.5|-43.4|-22.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-22.5|-43.4|<0.0001
71792904|NCT02584504|143084181|SUPERIORITY||Adjusted Mean Difference|-50.9|||<|0.0001|TWO_SIDED|97.5|-61.5|-40.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||-40.3|-61.5|<0.0001
71792905|NCT02584504|143084182|SUPERIORITY||LS Mean Difference|5.7||||0.0241|TWO_SIDED|97.5|0.0|11.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||11.3|0.0|0.0241
71792906|NCT02584504|143084182|SUPERIORITY||LS Mean Difference|7.8||||0.0022|TWO_SIDED|97.5|2.1|13.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||13.5|2.1|0.0022
71838710|NCT06424236|143185993|OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.989|TWO_SIDED|95.0|-0.43|0.44|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.44|-0.43|0.989
71838711|NCT06424236|143185993|OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.533||0.714|TWO_SIDED|95.0|-0.86|1.25|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||1.25|-0.86|0.714
71672615|NCT00630825|142863510|SUPERIORITY_OR_OTHER|||||||0.113||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.113
71672616|NCT00630825|142863510|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672617|NCT00630825|142863510|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672618|NCT00630825|142863510|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672619|NCT00630825|142863510|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||<0.001
71672620|NCT00630825|142863510|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.004
71672621|NCT00630825|142863510|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.001
71792907|NCT02584504|143084183|SUPERIORITY||Adjusted Mean Difference|5.9||||0.2645|TWO_SIDED|97.5|-5.9|17.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||17.7|-5.9|0.2645
71792908|NCT02584504|143084183|SUPERIORITY||Adjusted Mean Difference|-11.6||||0.0299|TWO_SIDED|97.5|-23.5|0.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).||0.4|-23.5|0.0299
71792909|NCT03453684|143084227|OTHER||Overall SE of the estimate|0.009|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.45 Standard error of the estimate of w\^2: 0.39|||||
71792910|NCT03453684|143084228|OTHER||Overall Standard Error of the Estimate|9.85|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.61 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
71792911|NCT03453684|143084229|OTHER||Overall Standard Error of the Estimate|8.37|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02 Standard error of the estimate of ꙍ\^2 (intersubject variability): \^a (fixed to 0)|||||
71792912|NCT03453684|143084230|OTHER||Overall Standard Error of the Estimate|4.83|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.003 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.03|||||
71792913|NCT03453684|143084231|OTHER||Overall Standard Error of the Estimate|17.21|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.13|||||
71792914|NCT03453684|143084232|OTHER||SE of the estimate of Typical Value|0.2|||||TWO_SIDED|||||||||||||
71792915|NCT03453684|143084233|OTHER||SE of the estimate of Typical Value|2.1|||||TWO_SIDED||||||||Standard error of the estimate of Typical value should be read as: 2.1E-06 Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.24|||||
71792916|NCT03453684|143084234|OTHER||SE of the estimate of Typical Value|2.3|||||TWO_SIDED||||||||Standard error of the estimate of ꙍ\^2 (intersubject variability): 0.08|||||
71838712|NCT06424236|143185994|OTHER||LS mean|-0.03|STANDARD_ERROR_OF_MEAN|0.077||0.738|TWO_SIDED|95.0|-0.18|0.13|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.13|-0.18|0.738
71792917|NCT03453684|143084235|OTHER||Overall Standard Error of the Estimate|10.8|||||TWO_SIDED||||||||Standard error of the estimate of Typical value: 0.02|||||
71792918|NCT03453684|143084236|OTHER||SE of the estimate of Typical Value|0.9|||||TWO_SIDED|||||||||||||
71792919|NCT02449174|143084304|SUPERIORITY|||||||0.8958|||||||Chi-squared, Corrected|||||||0.8958
71792920|NCT02449174|143084305|SUPERIORITY|||||||0.2059|||||||Chi-squared, Corrected|||||||0.2059
71792921|NCT00751348|143084307|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.|Difference in percentage|-1.36|||<|0.05|TWO_SIDED|95.0|-3.77|1.66||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.||1.66|-3.77|<0.05
71792922|NCT00751348|143084307|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%.|Difference in percentage|-5.34|||<|0.05|TWO_SIDED|95.0|-10.4|0.38||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.||0.38|-10.4|<0.05
71792923|NCT00751348|143084307|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%.|Difference in percentage|-0.34|||<|0.05|TWO_SIDED|95.0|-1.88|2.06||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.||2.06|-1.88|<0.05
71792924|NCT00751348|143084307|NON_INFERIORITY|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%.|Difference in percentage|-1.06|||<|0.05|TWO_SIDED|95.0|-3.07|1.44||The P-value for all reactogenicity comparisons was below (\<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.||1.44|-3.07|<0.05
71792925|NCT01826487|143084351|OTHER||Mean Difference (Final Values)|12.98|STANDARD_ERROR_OF_MEAN|10.415||0.213|TWO_SIDED|95.0|-7.44|33.39||Threshold for significance at 0.05. Secondary endpoints were tested for significance, only if the primary endpoint was statistically significant.|Mixed Models Analysis|||Analysis was performed using analysis of covariance (ANCOVA) method including stratification factors for age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years), duration of use of corticosteroids at baseline (approx. \>=6 to \<12 months vs. \>=12 months), and baseline 6MWD category (\>=350 meters vs \<350 meters), as well as baseline 6MWD as covariate.||33.39|-7.44|0.213
71792926|NCT01408030|143084362|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.97|||||||ANOVA|||||||0.97
71792927|NCT01408030|143084363|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.47|||||||ANOVA|||||||.47
71892780|NCT02469246|143306793|SUPERIORITY||Difference in LSM|-39.0||||0.013|TWO_SIDED|95.0|-70.0|-8.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||-8|-70|0.013
71792928|NCT01408030|143084364|OTHER|Two sided testing was performed with a significance level of 0.05.|||||<|0.001||||||"A mixed-model repeated-measures ANOVA was used to analyze ESS for drug and time (baseline, week 12) effects.~Listed P value is for time effect."|Mixed Models Analysis|Clinical site and patient were included in the model as random effects.||||||<0.001
71792929|NCT01408030|143084365|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.43|||||||ANCOVA|Adjusted for baseline values and random effect of clinic site.||||||0.43
71792930|NCT01408030|143084366|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.42|||||||Fisher Exact|||||||0.42
71792931|NCT01408030|143084367|OTHER|Two sided testing was performed with a significance level of 0.05.||||||0.08|||||||Fisher Exact|||||||0.08
71792932|NCT00003641|143084369|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964|TWO_SIDED||||||Log Rank|stratified on the stratification factors used for randomization||||||0.964
71792933|NCT00003641|143084370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|TWO_SIDED||||||Log Rank|Stratified on the stratification factors used for randomization||||||0.558
71792934|NCT00878709|143084395|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.008|TWO_SIDED|95.0|0.49|0.9|||Log Rank|The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.90|0.49|0.008
71792935|NCT00878709|143084397|SUPERIORITY||Hazard Ratio (HR)|0.952||||0.6914|TWO_SIDED|95.0|0.747|1.212|||Log Rank|||The 2-sided P-value was based on stratified log-rank test (stratification factors: prior Trastuzumab (concurrent or sequential), nodal status (\<=3 or \>=4) and ER/PgR status (positive or negative). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.212|0.747|0.6914
71792936|NCT00878709|143084398|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.45|0.83|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.||0.83|0.45|
71792937|NCT00878709|143084400|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.05|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.||1.05|0.52|
71792938|NCT00878709|143084402|OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.||1.04|0.51|
71792939|NCT00878709|143084406|OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.92||The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Log Rank||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.||0.92|0.57|0.008
71792940|NCT00878709|143084408|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.56|0.89|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||0.89|0.56|
71792941|NCT00878709|143084409|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.01|0.6|
71792942|NCT00878709|143084410|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.03|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (\<= 3 or \>= 4) and ER/PgR status (positive or negative).|||1.03|0.60|
71792943|NCT03886220|143084415|SUPERIORITY||Odds Ratio (OR)|3.22||||0.035|TWO_SIDED|95.0|1.086|9.546||P-value for test of difference between elagolix dose group and placebo is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.|Regression, Logistic|||||9.546|1.086|0.035
71792944|NCT00768300|143084416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.01|TWO_SIDED|95.0|1.14|2.66||P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.|Log Rank||The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.|||2.66|1.14|0.010
71792945|NCT00768300|143084418|SUPERIORITY_OR_OTHER||Point estimate|4.29||||0.086|TWO_SIDED|95.0|-0.805|9.376||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||9.376|-0.805|0.086
71792946|NCT00768300|143084419|SUPERIORITY_OR_OTHER||Point estimate|2.85||||0.25|TWO_SIDED|95.0|-2.2|7.9||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||7.90|-2.20|0.250
71838713|NCT06424236|143185994|OTHER||LS mean|0.19|STANDARD_ERROR_OF_MEAN|0.222||0.395|TWO_SIDED|95.0|-0.28|0.66|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.66|-0.28|0.395
71792947|NCT00768300|143084420|SUPERIORITY_OR_OTHER||Point estimate|16.0||||0.15|TWO_SIDED|95.0|-5.0|37.0||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.|||37.00|-5.00|0.150
71792948|NCT00768300|143084423|SUPERIORITY_OR_OTHER||Point estimate|0.5||||0.793|TWO_SIDED|95.0|0.0|1.0||The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).|Wilcoxon (Mann-Whitney)||The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect|||1.00|0.00|0.793
71792949|NCT04665050|143084445|OTHER|Estimated difference and confidence interval (CI) are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Injection Site Erythema||12.7|-12.7|
71792950|NCT04665050|143084445|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-11.8|||||TWO_SIDED|95.0|-30.0|7.3|||||V116 minus PNEUMOVAX™23|Injection Site Pain||7.3|-30.0|
71792951|NCT04665050|143084445|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-14.1|14.1|||||V116 minus PNEUMOVAX™23|Injection Site Swelling||14.1|-14.1|
71792952|NCT04665050|143084446|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|3.9|||||TWO_SIDED|95.0|-9.4|17.5|||||V116 minus PNEUMOVAX™23|Fatigue||17.5|-9.4|
71792953|NCT04665050|143084446|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-9.9|9.9|||||V116 minus PNEUMOVAX™23|Arthralgia||9.9|-9.9|
71792954|NCT04665050|143084446|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|-2.0|||||TWO_SIDED|95.0|-17.5|13.6|||||V116 minus PNEUMOVAX™23|Myalgia||13.6|-17.5|
71792955|NCT04665050|143084446|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-12.7|12.7|||||V116 minus PNEUMOVAX™23|Headache||12.7|-12.7|
71792956|NCT04665050|143084447|OTHER|Estimated difference and CI are calculated based on the Miettinen \& Nurminen method|Difference in percentage|0.0|||||TWO_SIDED|95.0|-7.1|7.1|||||V116 minus PNEUMOVAX™23|||7.1|-7.1|
71838714|NCT06424236|143185995|OTHER||LS mean|-2.176|STANDARD_DEVIATION|2.89551|<|0.0001|TWO_SIDED|95.0|-2.9469|-1.4051|||MMRM|||Week 56: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-1.4051|-2.9469|<0.0001
71838715|NCT06424236|143185995|OTHER||LS mean|-4.8434|STANDARD_DEVIATION|3.78771|<|0.0001|TWO_SIDED|95.0|-5.8609|-3.826|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-3.8260|-5.8609|<0.0001
71792957|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.07|2.4|||||V116/PNEUMOVAX™23|Serotype 3||2.40|1.07|
71792958|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.21|||||TWO_SIDED|95.0|0.69|2.11|||||V116/PNEUMOVAX™23|Serotype 7F||2.11|0.69|
71792959|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.24|3.24|||||V116/PNEUMOVAX™23|Serotype 19A||3.24|1.24|
71792960|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.92|||||TWO_SIDED|95.0|1.04|3.57|||||V116/PNEUMOVAX™23|Serotype 22F||3.57|1.04|
71792961|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.15|||||TWO_SIDED|95.0|0.71|1.86|||||V116/PNEUMOVAX™23|Serotype 33F||1.86|0.71|
71792962|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.78|||||TWO_SIDED|95.0|1.24|2.58|||||V116/PNEUMOVAX™23|Serotype 8||2.58|1.24|
71792963|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|1.89|||||TWO_SIDED|95.0|1.19|3.0|||||V116/PNEUMOVAX™23|Serotype 9N||3.00|1.19|
71792964|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.71|||||TWO_SIDED|95.0|1.47|5.0|||||V116/PNEUMOVAX™23|Serotype 10A||5.00|1.47|
71792965|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.43|||||TWO_SIDED|95.0|1.52|3.89|||||V116/PNEUMOVAX™23|Serotype 11A||3.89|1.52|
71792966|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.4|||||TWO_SIDED|95.0|1.2|4.83|||||V116/PNEUMOVAX™23|Serotype 12F||4.83|1.20|
71792967|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.57|||||TWO_SIDED|95.0|1.59|4.17|||||V116/PNEUMOVAX™23|Serotype 17F||4.17|1.59|
71792968|NCT04665050|143084448|OTHER|GMT ratio and 95% confidence interval CI are estimated from a cLDA model.|GMT Ratio|2.28|||||TWO_SIDED|95.0|1.46|3.56|||||V116/PNEUMOVAX™23|Serotype 20A||3.56|1.46|
71792969|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.54|||||TWO_SIDED|95.0|1.08|2.21|||||V116/PNEUMOVAX™23|Serotype 3||2.21|1.08|
71792970|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.21|||||TWO_SIDED|95.0|1.36|3.6|||||V116/PNEUMOVAX™23|Serotype 7F||3.60|1.36|
71792971|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.45|3.23|||||V116/PNEUMOVAX™23|Serotype 19A||3.23|1.45|
71792972|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.33|||||TWO_SIDED|95.0|1.36|3.99|||||V116/PNEUMOVAX™23|Serotype 22F||3.99|1.36|
71792973|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.52|||||TWO_SIDED|95.0|0.97|2.37|||||V116/PNEUMOVAX™23|Serotype 33F||2.37|0.97|
71672622|NCT00630825|142863511|SUPERIORITY_OR_OTHER|||||||0.009||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.009
71672623|NCT00630825|142863511|SUPERIORITY_OR_OTHER|||||||0.028||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.028
71672624|NCT00630825|142863511|SUPERIORITY_OR_OTHER|||||||0.047||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA|||||||0.047
71672625|NCT02792062|142863530|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|113.06||||0.659|TWO_SIDED|90.0|70.37|181.67|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||181.67|70.37|0.659
71672626|NCT02792062|142863530|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|45.43||||0.012|TWO_SIDED|90.0|27.86|74.07|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||74.07|27.86|0.012
71792974|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.88|||||TWO_SIDED|95.0|1.32|2.68|||||V116/PNEUMOVAX™23|Serotype 8||2.68|1.32|
71792975|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.37|||||TWO_SIDED|95.0|1.49|3.74|||||V116/PNEUMOVAX™23|Serotype 9N||3.74|1.49|
71838716|NCT06424236|143185995|OTHER||LS mean|-5.762|STANDARD_DEVIATION|3.31129|<|0.0001|TWO_SIDED|95.0|-6.9679|-4.5561|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF pTau181 as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||-4.5561|-6.9679|<0.0001
71672627|NCT02792062|142863531|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.28||||0.238|TWO_SIDED|90.0|66.09|107.47|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||107.47|66.09|0.238
71672628|NCT02792062|142863531|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|53.2|||<|0.001|TWO_SIDED|90.0|41.39|68.37|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||68.37|41.39|<0.001
71672629|NCT02792062|142863532|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
71672630|NCT02792062|142863532|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
71672631|NCT02792062|142863533|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|84.68||||0.256|TWO_SIDED|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast - value in fasted condition without breakfast).||108.27|66.23|0.256
71672632|NCT02792062|142863533|SUPERIORITY_OR_OTHER||Least Square Mean Ratio (%)|52.56|||<|0.001|TWO_SIDED|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast - value in fasted condition without breakfast).||67.74|40.78|<0.001
71672633|NCT03309943|142863540|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.019|||||||Mixed Models Analysis|Adjusted for FTCD. Carried out using SPSS Mixed Models with a repeated statement and compound symmetry covariance structure.||||||.019
71792976|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.16|||||TWO_SIDED|95.0|1.28|3.65|||||V116/PNEUMOVAX™23|Serotype 10A||3.65|1.28|
71792977|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|1.92|||||TWO_SIDED|95.0|1.28|2.89|||||V116/PNEUMOVAX™23|Serotype 11A||2.89|1.28|
71792978|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.49|||||TWO_SIDED|95.0|1.94|6.27|||||V116/PNEUMOVAX™23|Serotype 12F||6.27|1.94|
71792979|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.88|||||TWO_SIDED|95.0|1.92|4.31|||||V116/PNEUMOVAX™23|Serotype 17F||4.31|1.92|
71792980|NCT04665050|143084449|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|2.05|||||TWO_SIDED|95.0|1.3|3.25|||||V116/PNEUMOVAX™23|Serotype 20A||3.25|1.30|
71792981|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|3.58|||||TWO_SIDED|95.0|1.86|6.88|||||V116/PNEUMOVAX™23|Serotype 6A||6.88|1.86|
71838717|NCT06424236|143185996|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.022||0.055|TWO_SIDED|95.0|0.0|0.09|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with variance components covariance matrix.||0.09|0.00|0.055
71792982|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|6.23|||||TWO_SIDED|95.0|3.54|10.98|||||V116/PNEUMOVAX™23|Serotype 15A||10.98|3.54|
71838718|NCT06424236|143185996|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.034||0.188|TWO_SIDED|95.0|-0.02|0.11|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.11|-0.02|0.188
71838719|NCT06424236|143185997|OTHER||LS mean|0.0067|STANDARD_DEVIATION|0.0124||0.0001|TWO_SIDED|95.0|0.0034|0.01|||MMRM|||Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0100|0.0034|0.0001
71838720|NCT06424236|143185997|OTHER||LS mean|0.0251|STANDARD_DEVIATION|0.02262|<|0.0001|TWO_SIDED|95.0|0.0189|0.0312|||MMRM|||Week 104: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0312|0.0189|<0.0001
71838721|NCT06424236|143185997|OTHER||LS mean|0.0357|STANDARD_DEVIATION|0.02467|<|0.0001|TWO_SIDED|95.0|0.0266|0.0447|||MMRM|||Week 156: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline CSF Amyloid Beta1-42/40 score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.||0.0447|0.0266|<0.0001
71838722|NCT06424236|143185998|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.081||0.644|TWO_SIDED|95.0|-0.12|0.2|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Asymptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.20|-0.12|0.644
71838723|NCT06424236|143185998|OTHER||LS mean|0.04|STANDARD_ERROR_OF_MEAN|0.111||0.745|TWO_SIDED|95.0|-0.18|0.26|||Linear Mixed Effects Model||Estimated value is the difference in the rate of change between the treatment group and control group.|Baseline Symptomatic Participants: The statistical model included time since baseline (years), treatment arm, an interaction between treatment and time. Time was considered as continuous. Random intercepts and slopes for each participant was included as random effects with an unstructured covariance matrix.||0.26|-0.18|0.745
71838724|NCT04213872|143185999|OTHER|||||||0.01|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCI 25.4 (14.2) 17.3 (10.5) \*-8.1 (3.7) .01~\*reduction in scores indicate improvement."||||.01
71838725|NCT04213872|143186000|OTHER|||||||0.03|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogPCA 16.0 (5.1) 19.2 (5.3) 3.2 (0.2) .03||||.03
71838726|NCT04213872|143186001|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogQOL 3.7 (3.8) 1.8 (2.2) \*-1.9 (1.6) .04~\*lower scores signifying better outcomes."||||.04
71838727|NCT04213872|143186002|OTHER|||||||0.04|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value CogOth 1.5 (2.1) 0.2 (0.4) \*-1.3 (1.7) .04~\*lower scores signifying better outcomes."||||.04
71838728|NCT04213872|143186003|OTHER|||||||0.01|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value WAIS-III Letter/Number 10.7 (3.2) 12.7 (2.8) 2.0 (0.4) .01||||.01
71892781|NCT02469246|143306794|SUPERIORITY||Difference in LSM|0.179||||0.4|TWO_SIDED|95.0|-0.24|0.598||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.598|-0.240|0.40
71792983|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|2.33|||||TWO_SIDED|95.0|1.23|4.39|||||V116/PNEUMOVAX™23|Serotype 15C||4.39|1.23|
71838729|NCT04213872|143186004|OTHER|||||||0.6|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value~WAIS-III Digit Span Forward and Backward 19.2 (4.8) 19.7 (4.4) 0.5 (0.4) .60"||||.60
71892782|NCT02469246|143306795|SUPERIORITY||Difference in LSM|0.165||||0.53|TWO_SIDED|95.0|-0.348|0.678||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.678|-0.348|0.53
71892783|NCT02469246|143306796|SUPERIORITY||Difference in LSM|0.151||||0.63|TWO_SIDED|95.0|-0.465|0.767||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.767|-0.465|0.63
71792984|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|10.06|||||TWO_SIDED|95.0|5.39|18.78|||||V116/PNEUMOVAX™23|Serotype 16F||18.78|5.39|
71792985|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|42.09|||||TWO_SIDED|95.0|19.67|90.03|||||V116/PNEUMOVAX™23|Serotype 23A||90.03|19.67|
71792986|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|12.37|||||TWO_SIDED|95.0|6.97|21.94|||||V116/PNEUMOVAX™23|Serotype 23B||21.94|6.97|
71792987|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|24.82|||||TWO_SIDED|95.0|11.65|52.86|||||V116/PNEUMOVAX™23|Serotype 24F||52.86|11.65|
71672634|NCT03309943|142863541|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.83|||||||Mixed Models Analysis|Adjusted for FTCD||||||.830
71672635|NCT03309943|142863542|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.006|||||||Mixed Models Analysis|||||||.006
71672636|NCT03309943|142863543|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.653|||||||Mixed Models Analysis|||||||.653
71672637|NCT03309943|142863544|SUPERIORITY|Mixed model analysis examining the effects of drug condition on response to smoking vs. non-smoking cues (collapsed across category - proximal, standard environment, personal environment). Data were analyzed using the underlying raw values versus collapsing them together.||||||0.012|||||||Mixed Models Analysis|Adjusted for FTCD||||||.012
71672638|NCT03309943|142863545|SUPERIORITY|Mixed model analysis examining the effects of drug condition on PPI indexes while viewing proximal smoking cues (which drove activation effects).||||||0.013|||||||Mixed Models Analysis|||||||.013
71792988|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|25.66|||||TWO_SIDED|95.0|14.65|44.93|||||V116/PNEUMOVAX™23|Serotype 31||44.93|14.65|
71792989|NCT04665050|143084450|OTHER|GMT ratio and 95% CI are estimated from a cLDA model.|GMT Ratio|14.3|||||TWO_SIDED|95.0|8.72|23.47|||||V116/PNEUMOVAX™23|Serotype 35B||23.47|8.72|
71838730|NCT04213872|143186005|OTHER|||||||0.03|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value PSQI 1.5 (0.8) 0.9 (0.7) \*-0.6 (0.1) .03~\*Lower scores mean better outcomes."||||.03
71838731|NCT04213872|143186006|OTHER|||||||0.05|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Anxiety 9.2 (7.7) 4.2 (3.7) \*-5.0 (4.0) .05~\*Lower scores mean better outcomes."||||.05
71838732|NCT04213872|143186007|OTHER|||||||0.08|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value POMS Depression 4.1 (4.9) 2.0 (3.0) \*-2.1 (1.9) .08~\*Lower scores mean better outcomes."||||.08
71838733|NCT04213872|143186008|OTHER|||||||0.3|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value BDNF 0.11 (0.9) 0.30 (0.7) 0.19 (0.2) .30~Higher scores mean better outcomes."||||.30
71838734|NCT04213872|143186009|OTHER|||||||0.8|||||||t-test, 2 sided|||"Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value NF-kB1 171.7 (25.4) 173.7 (21.6) 2.0 (3.8) .80~Higher scores mean better outcomes."||||.80
71838735|NCT04213872|143186010|OTHER|||||||0.61|||||||t-test, 2 sided|||Measure Pre-MM mean (sd) Post-MM mean (sd) Pre/Post MM mean (sd) difference P-Value TP53 12.3 (2.7) 13.1 (5.5) 0.8 (2.8) .61||||.61
71672639|NCT03309943|142863546|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.024|||||||Repeated Measures ANCOVA|Adjusted for FTCD.||||||.024
71672640|NCT03309943|142863547|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.086|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.086
71672641|NCT03309943|142863548|SUPERIORITY|Repeated Measures ANCOVA analysis examining condition differences (adjusting for FTCD score)||||||0.14|||||||Repeated Measures ANCOVA|Adjusted for FTCD score||||||.140
71672642|NCT03309943|142863549|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for baseline craving and FTCD score).||||||0.556|||||||ANCOVA|Adjusted for baseline craving and FTCD score||||||.556
71672643|NCT03309943|142863550|SUPERIORITY|Standard ANCOVA analysis examining condition differences (adjusting for FTCD score).||||||0.463||||||Adjusted for FTCD score only.|ANCOVA|||||||.463
71672644|NCT00427648|142863576|SUPERIORITY|||||||0.588|||||||Kruskal-Wallis|||null hypothesis - no difference in average number of voids between the 2 groups, power calculation estimated 40 participants needed per arm to show a 2 void difference between lidocaine and saline placebo.||||0.588
71672645|NCT00427648|142863577|SUPERIORITY|||||||0.617|||||||Kruskal-Wallis|||||||0.617
71672646|NCT00427648|142863578|SUPERIORITY|||||||0.441|||||||Kruskal-Wallis|||||||0.441
71672647|NCT00427648|142863579|SUPERIORITY|||||||0.189|||||||Kruskal-Wallis|||||||0.189
71672648|NCT00427648|142863580|SUPERIORITY|||||||0.342|||||||Kruskal-Wallis|||||||0.342
71672649|NCT00427648|142863581|SUPERIORITY|||||||0.802|||||||Kruskal-Wallis|||||||0.802
71672650|NCT00427648|142863582|SUPERIORITY|||||||0.366|||||||Kruskal-Wallis|||||||0.366
71672651|NCT02282813|142863600|SUPERIORITY_OR_OTHER|||||||0.1041|||||||Cochran-Mantel-Haenszel|||||||0.1041
71672652|NCT02282813|142863601|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Cochran-Mantel-Haenszel|||||||.0503
71672653|NCT02282813|142863602|SUPERIORITY_OR_OTHER|||||||0.4817|||||||Cochran-Mantel-Haenszel|||||||0.4817
71672654|NCT02282813|142863603|SUPERIORITY_OR_OTHER|||||||0.8086|||||||Cochran-Mantel-Haenszel|||||||0.8086
71672655|NCT03858998|142863604|SUPERIORITY||Risk Difference (RD)|0.004||||0.91|TWO_SIDED|95.0|-0.06|0.07|||Chi-squared||Direction = Linkage minus SOC|||0.07|-0.06|0.91
71672656|NCT03493854|142863617|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|1.14|1.31|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm A SC dose is inferior to the pertuzumab Arm B IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.31|1.14|
71792990|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.0|||||TWO_SIDED|95.0|1.73|5.19|||||V116/PNEUMOVAX™23|Serotype 6A||5.19|1.73|
71792991|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.03|||||TWO_SIDED|95.0|4.61|13.98|||||V116/PNEUMOVAX™23|Serotype 15A||13.98|4.61|
71792992|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|3.14|||||TWO_SIDED|95.0|1.77|5.58|||||V116/PNEUMOVAX™23|Serotype 15C||5.58|1.77|
71672657|NCT03493854|142863618|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.33|||||TWO_SIDED|90.0|1.24|1.43|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.43|1.24|
71672658|NCT03493854|142863619|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|0.15|||||TWO_SIDED|95.0|-8.67|8.97|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||8.97|-8.67|
71792993|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|13.06|||||TWO_SIDED|95.0|8.45|20.19|||||V116/PNEUMOVAX™23|Serotype 16F||20.19|8.45|
71792994|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|8.55|||||TWO_SIDED|95.0|5.19|14.09|||||V116/PNEUMOVAX™23|Serotype 23A||14.09|5.19|
71792995|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|4.15|||||TWO_SIDED|95.0|2.72|6.36|||||V116/PNEUMOVAX™23|Serotype 23B||6.36|2.72|
71792996|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|28.68|||||TWO_SIDED|95.0|16.59|49.58|||||V116/PNEUMOVAX™23|Serotype 24F||49.58|16.59|
71792997|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|10.27|||||TWO_SIDED|95.0|6.71|15.73|||||V116/PNEUMOVAX™23|Serotype 31||15.73|6.71|
71792998|NCT04665050|143084451|OTHER|GMC ratio and 95% CI are estimated from a cLDA model.|GMC Ratio|15.95|||||TWO_SIDED|95.0|11.62|21.9|||||V116/PNEUMOVAX™23|Serotype 35B||21.90|11.62|
71792999|NCT02867709|143084455|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0285|TWO_SIDED|95.0|1.09|2.22||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.22|1.09|0.0285
71793000|NCT02867709|143084455|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0129|TWO_SIDED|95.0|1.14|2.29||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.29|1.14|0.0129
71672659|NCT03493854|142863620|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.5216|TWO_SIDED|95.0|0.68|2.11|||Log Rank|||||2.11|0.68|0.5216
71672660|NCT03493854|142863621|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.15||||0.5992|TWO_SIDED|95.0|0.68|1.97|||Log Rank|||||1.97|0.68|0.5992
71672661|NCT03493854|142863622|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.2||||0.4844|TWO_SIDED|95.0|0.72|1.98|||Log Rank|||||1.98|0.72|0.4844
71672662|NCT03493854|142863623|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.16||||0.5474|TWO_SIDED|95.0|0.71|1.88|||Log Rank|||||1.88|0.71|0.5474
71672663|NCT03493854|142863624|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.17||||0.6291|TWO_SIDED|95.0|0.61|2.24|||Log Rank|||||2.24|0.61|0.6291
71793001|NCT02867709|143084456|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0711|TWO_SIDED|95.0|1.02|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||1.83|1.02|0.0711
71793002|NCT02867709|143084456|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0129|TWO_SIDED|95.0|1.25|2.2||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.||||2.20|1.25|0.0129
71793003|NCT02867709|143084457|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0711|TWO_SIDED|95.0|1.25|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.17|1.25|0.0711
71793004|NCT02867709|143084457|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0129|TWO_SIDED|95.0|1.35|2.32||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.32|1.35|0.0129
71793005|NCT02867709|143084458|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0711|TWO_SIDED|95.0|1.33|2.48||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.48|1.33|0.0711
71793006|NCT02867709|143084458|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0129|TWO_SIDED|95.0|1.59|2.92||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.92|1.59|0.0129
71793007|NCT02867709|143084459|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0711|TWO_SIDED|95.0|1.04|2.53||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.53|1.04|0.0711
71793008|NCT02867709|143084459|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0129|TWO_SIDED|95.0|1.2|2.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.||||2.83|1.20|0.0129
71793009|NCT02867709|143084460|SUPERIORITY||Odds Ratio (OR)|1.28||||0.1833|TWO_SIDED|95.0|0.96|1.72||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||1.72|0.96|0.1833
71672664|NCT03493854|142863625|OTHER|Descriptive analysis only|Hazard Ratio (HR)|1.26||||0.5609|TWO_SIDED|95.0|0.58|2.72|||Log Rank|||||2.72|0.58|0.5609
71672665|NCT02105987|142863651|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is -10%.|Mean Difference (Net)|-3.4|||||TWO_SIDED|95.0|-9.1|2.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||2.4|-9.1|
71793010|NCT02867709|143084460|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0167|TWO_SIDED|95.0|1.14|2.02||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.||||2.02|1.14|0.0167
71793011|NCT02867709|143084461|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1066|TWO_SIDED|95.0|1.04|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.83|1.04|0.1066
71793012|NCT02867709|143084461|SUPERIORITY||Odds Ratio (OR)|1.39||||0.044|TWO_SIDED|95.0|1.05|1.84||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.||||1.84|1.05|0.0440
71793013|NCT02867709|143084462|SUPERIORITY||Odds Ratio (OR)|1.1||||0.9522|TWO_SIDED|95.0|0.81|1.49||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.49|0.81|0.9522
71793014|NCT02867709|143084462|SUPERIORITY||Odds Ratio (OR)|1.12||||0.9522|TWO_SIDED|95.0|0.83|1.51||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.||||1.51|0.83|0.9522
71793015|NCT06002958|143084464|OTHER||Cohen's d|-0.29|||||TWO_SIDED|95.0|-0.815|0.255|||||Inner|||0.255|-0.815|
71793016|NCT06002958|143084464|OTHER||Cohen's d|0.02|||||TWO_SIDED|95.0|-0.503|0.545|||||Outer|||0.545|-0.503|
71793017|NCT06002958|143084464|OTHER||Cohen's d|-0.32|||||TWO_SIDED|95.0|-0.85|0.225|||||Individual|||0.225|-0.850|
71793018|NCT06002958|143084464|OTHER||Cohen's d|0.01|||||TWO_SIDED|95.0|-0.85|0.534|||||Process|||0.534|-0.850|
71793019|NCT05214768|143084472|SUPERIORITY||Least Square Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|74.98||0.003|TWO_SIDED|95.0|-370.2|-76.3|||ANCOVA|||||-76.3|-370.2|0.003
71672666|NCT02105987|142863653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-2.0|1.4|||Cochran-Mantel-Haenszel||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).|||1.4|-2.0|
71672667|NCT02105987|142863658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.096|TWO_SIDED|95.0|-0.02|0.23|||ANCOVA||Statistical analysis of cholesterol is presented|||0.23|-0.02|0.096
71672668|NCT02105987|142863658|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07||||0.167|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||Statistical analysis of LDL cholesterol is presented|||0.18|-0.03|0.167
71672669|NCT02105987|142863658|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.317|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA||Statistical analysis of HDL cholesterol is presented|||0.06|-0.02|0.317
71672670|NCT02105987|142863658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.187|TWO_SIDED|95.0|-0.05|0.27|||ANCOVA||Statistical analysis of triglycerides is presented|||0.27|-0.05|0.187
71672671|NCT02105987|142863659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.175|TWO_SIDED|95.0|-0.04|0.25|||ANCOVA||Statistical analysis of total cholesterol/HDL cholesterol ratio is presented|||0.25|-0.04|0.175
71672672|NCT02105987|142863660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.5|||ANCOVA||Statistical analysis for total score is presented|||3.5|1.3|<0.001
71793020|NCT04303780|143084527|EQUIVALENCE|A hazard ratio \<1.0 indicates a lower average event rate and a longer PFS for AMG 510 relative to docetaxel. P-value was calculated using a stratified log-rank test.|Hazard Ratio (HR)|0.663||||0.002|TWO_SIDED|95.0|0.509|0.864|||Log Rank|||||0.864|0.509|0.002
71793021|NCT02967692|143084570|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.042|TWO_SIDED|95.0|0.655|1.027|||Log Rank|||||1.027|0.655|0.042
71793022|NCT02967692|143084578|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.2975|TWO_SIDED|95.0|0.865|1.619|||Log Rank|||||1.619|0.865|0.2975
71793023|NCT04916600|143084595|SUPERIORITY||Difference in percentages|22.0||||0.043|TWO_SIDED|||||The threshold for statistical significance was p = .05|Chi-squared||Treatment difference = Active device \>=24 hour group - remainder of participants (Active \<24 hr, Sham \>=24 hr, and Sham \<24 hr groups)|||||.043
71793024|NCT04916600|143084596|SUPERIORITY||Mean Difference (Net)|-3.4||||0.032|TWO_SIDED|||||The threshold for statistical significance was p = .05|t-test, 2 sided|df=101||||||.032
71793025|NCT00066066|143084597|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||>0.05
71793026|NCT00066066|143084597|SUPERIORITY_OR_OTHER||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||>0.05
71793027|NCT00066066|143084597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||<0.05
71793028|NCT00066066|143084597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.||||<0.05
71793029|NCT00066066|143084597|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.||||<0.05
71793030|NCT00066066|143084597|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.||||>0.05
71793031|NCT02094716|143084870|SUPERIORITY|||||||0.6084|||||||Chi-squared|||||||0.6084
71793032|NCT02094716|143084872|SUPERIORITY|||||||0.6937|||||||Chi-squared|||||||0.6937
71793033|NCT02094716|143084873|SUPERIORITY|||||||0.101|||||||Fisher Exact|||||||0.1010
71793034|NCT02094716|143084873|SUPERIORITY|||||||0.0764|||||||Fisher Exact|||||||0.0764
71793035|NCT02436759|143084885|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Two-sided t-test with treatment as a fixed factor and baseline score as a covariate||||||<0.0001
71793036|NCT02436759|143084886|SUPERIORITY|||||||0.12|||||||ANCOVA|Two-sided t-test||||||0.12
71892784|NCT02469246|143306797|SUPERIORITY||Difference in LSM|-0.056||||0.89|TWO_SIDED|95.0|-0.825|0.713||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).|||0.713|-0.825|0.89
71892785|NCT04325503|143306832|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.0905||||0.015|TWO_SIDED|95.0|0.022|0.159||A priori threshold statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 9||||0.159|0.022|0.015
71892786|NCT04325503|143306833|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.333||||0.694|TWO_SIDED|95.0|-1.55|2.216||A priori threshold for statistical significance is p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||2.216|-1.550|0.694
71892787|NCT04325503|143306834|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|1.444||||0.103|TWO_SIDED|95.0|-0.363|3.252||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 8||||3.252|-0.363|0.103
71892788|NCT04325503|143306835|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-2.09||||0.321|TWO_SIDED|95.0|-6.554|2.372||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 10||||2.372|-6.554|0.321
71892789|NCT04325503|143306836|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|0.185||||0.265|TWO_SIDED|95.0|-0.175|0.544|||t-test, 2 sided|Paired samples t-test, df = 7||||0.544|-0.175|0.265
71892790|NCT04325503|143306837|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|8.143||||0.027|TWO_SIDED|95.0|1.296|15.0||A priori threshold for statistical significance p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 6||||15.0|1.296|0.0270
71892791|NCT04325503|143306838|OTHER|A comparison is not being made between two different treatment groups.||||||0.153||||||A priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.153
71892792|NCT00144170|143306854|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.5||||0.0001|TWO_SIDED|95.0|12.9|24.0|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||24.0|12.9|0.0001
71892793|NCT00144170|143306855|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71793037|NCT02603432|143084898|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0005|TWO_SIDED|95.0|0.556|0.863||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model.||||0.863|0.556|0.0005
71793038|NCT02603432|143084921|SUPERIORITY||Cox Proportional Hazard|1.26||||0.913|ONE_SIDED|95.0|0.901||||Log Rank||||||0.901|0.9130
71793039|NCT02666183|143084924|OTHER||Estimated marginal mean difference|-2.251||||0.162|TWO_SIDED|95.0|-5.051|0.55|||ANCOVA|Covariates: DCG age, gender, race, income||||0.550|-5.051|0.162
71793040|NCT02666183|143084924|OTHER||Estimated marginal mean difference|-3.663||||0.007|TWO_SIDED|95.0|-6.538|-0.789|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.789|-6.538|0.007
71793041|NCT02666183|143084924|OTHER||Estimated marginal mean difference|-1.413||||0.714|TWO_SIDED|95.0|-4.29|1.464|||ANCOVA|Covariates: DCG age, gender, race, income||||1.464|-4.290|0.714
71793042|NCT02666183|143084925|OTHER||Estimated marginal mean difference|-0.531||||0.173|TWO_SIDED|95.0|-1.297|0.234|||ANCOVA|Covariates: DCG age, gender, race, income||||0.234|-1.297|0.173
71793043|NCT02666183|143084925|OTHER||Estimated marginal mean difference|-1.456||||0.001|TWO_SIDED|95.0|-2.241|-0.671|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.671|-2.241|0.001
71793044|NCT02666183|143084925|OTHER||Estimated marginal mean difference|-0.925||||0.021|TWO_SIDED|95.0|-1.711|-0.139|||ANCOVA|Covariates: DCG age, gender, race, income||||-0.139|-1.711|0.021
71793045|NCT02666183|143084926|OTHER||Estimated marginal mean difference|-0.984||||0.323|TWO_SIDED|95.0|-2.939|0.971|||ANCOVA|Covariates: DCG age, gender, race, income||||0.971|-2.939|0.323
71793046|NCT02666183|143084926|OTHER||Estimated marginal mean difference|-1.768||||0.086|TWO_SIDED|95.0|-3.785|0.249|||ANCOVA|Covariates: DCG age, gender, race, income||||0.249|-3.785|0.086
71793047|NCT02666183|143084926|OTHER||Estimated marginal mean difference|-0.784||||0.443|TWO_SIDED|95.0|-2.794|1.226|||ANCOVA|Covariates: DCG age, gender, race, income||||1.226|-2.794|0.443
71793048|NCT05954052|143084928|SUPERIORITY||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|9.0||0.1807|TWO_SIDED|95.0|-6.24|14.24|||Wilcoxon (Mann-Whitney)|||For the analysis of (ABC) scores at baseline and 12 weeks in this single-arm, open-label pilot study (n=6 participants, all with paired data including the early dropout), we use superiority test, This aligns with the study's hypothesis that oral glutathione supplementation would lead to an improvement (i.e., a decrease in ABC scores, indicating reduced irritability). Superiority testing evaluates whether the post-treatment mean (or median) is significantly lower than the baseline||14.24|-6.24|0.1807
71793049|NCT03616912|143084934|SUPERIORITY||Odds Ratio (OR)|1.57||||0.016|TWO_SIDED|95.0|1.09|2.27|||Regression, Logistic|||||2.27|1.09|0.016
71793050|NCT03616912|143084935|SUPERIORITY||Odds Ratio (OR)|1.14||||0.47|TWO_SIDED|95.0|0.79|1.65|||Regression, Logistic|||||1.65|0.79|0.470
71838736|NCT03339713|143186011|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.55|1.11|||t-test, 1 sided|||A/Michigan strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.11|0.55|<.001
71838737|NCT03339713|143186011|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|0.8|||<|0.001|TWO_SIDED|90.0|0.59|1.12|||t-test, 1 sided|||A/Hong Kong strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.12|0.59|<.001
71838738|NCT03339713|143186011|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.77|1.34|||t-test, 1 sided|||B/Brisbane strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.34|0.77|<.001
71838739|NCT03339713|143186011|NON_INFERIORITY|Non-inferiority of Group 2 versus Group 1 in terms of the HI antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, using a non-inferiority margin of 2 for the GMT ratio (Group 2 / Group 1).|Geometric Mean Ratio|1.0|||<|0.001|TWO_SIDED|90.0|0.76|1.36|||t-test, 1 sided|||B/Phuket strain: Based on Welch-Satterthwaite t-interval method. The difference (Group 2 minus Group 1) and CI in log-transformed HI antibody titers were calculated for each of the 4 influenza vaccine strains, and were back-transformed (by exponentiation) to a GMT ratio (Group 2 / Group 1) and the corresponding CI.||1.36|0.76|<.001
71838740|NCT01715285|143186042|SUPERIORITY||Hazard Ratio (HR)|0.466|||<|0.0001|TWO_SIDED|95.0|0.394|0.55|||Log Rank|||||0.550|0.394|<0.0001
71838741|NCT01715285|143186043|SUPERIORITY||Hazard Ratio (HR)|0.661|||<|0.0001|TWO_SIDED|95.0|0.564|0.775|||Log Rank|||||0.775|0.564|< 0.0001
71672673|NCT02105987|142863660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.002|TWO_SIDED|95.0|0.4|1.7|||ANCOVA||Statistical analysis for general satisfaction/clinical subscale score is presented|||1.7|0.4|0.002
71838742|NCT01389856|143186064|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
71838743|NCT01389856|143186065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3407|TWO_SIDED||||||Log Rank|||||||0.3407
71838744|NCT01389856|143186066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2399|TWO_SIDED||||||Log Rank|||||||0.2399
71838745|NCT01389856|143186068|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71838746|NCT01389856|143186069|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2235|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2235
71892794|NCT00144170|143306856|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.9||||0.0001|TWO_SIDED|95.0|18.6|31.1|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||31.1|18.6|0.0001
71892795|NCT00144170|143306857|SUPERIORITY_OR_OTHER||Risk Difference (RD)|28.8||||0.0001|TWO_SIDED|95.0|22.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|22.5|0.0001
71838747|NCT01389856|143186070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1468|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1468
71838748|NCT01389856|143186071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0789|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0789
71838749|NCT01389856|143186072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3723
71838750|NCT01389856|143186073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0569|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0569
71838751|NCT01389856|143186074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1015|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1015
71838752|NCT01389856|143186075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0824|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.0824
71838753|NCT01389856|143186076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3863|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3863
71838754|NCT01389856|143186077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.3936
71838755|NCT01389856|143186078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2436|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.2436
71838756|NCT01389856|143186079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1756|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1756
71838757|NCT01389856|143186080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1155|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1155
71838758|NCT01389856|143186081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|TWO_SIDED||||||Non-parametric ANCOVA|||||||0.1400
71892796|NCT00144170|143306858|SUPERIORITY_OR_OTHER||Risk Difference (RD)|29.4||||0.0001|TWO_SIDED|95.0|23.2|35.7|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||35.7|23.2|0.0001
71892797|NCT00144170|143306859|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.6||||0.0001|TWO_SIDED|95.0|20.5|32.6|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||32.6|20.5|0.0001
71892798|NCT00144170|143306860|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.1||||0.0001|TWO_SIDED|95.0|16.2|27.9|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata||||27.9|16.2|0.0001
71672674|NCT02105987|142863660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.8|||ANCOVA||Statistical analysis for lifestyle/ease subscale is presented|||1.8|0.8|<0.001
71672675|NCT02105987|142863661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51|||<|0.001|TWO_SIDED|95.0|4.86|8.16|||ANCOVA|||||8.16|4.86|<0.001
71672676|NCT02105987|142863662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.87|||<|0.001|TWO_SIDED|95.0|-8.64|-5.11|||ANCOVA|||||-5.11|-8.64|<0.001
71672677|NCT02105987|142863663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||<|0.001|TWO_SIDED|95.0|-0.17|-0.1|||ANCOVA|||||-0.10|-0.17|<0.001
71672678|NCT02105987|142863664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.375|TWO_SIDED|95.0|-0.31|0.12|||ANCOVA|||||0.12|-0.31|0.375
71672679|NCT02105987|142863665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.749|TWO_SIDED|95.0|-0.93|1.3|||ANCOVA|||||1.30|-0.93|0.749
71672680|NCT02105987|142863666|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.82|0.9||Bone specific alkaline phosphatase|ANCOVA|||||0.90|0.82|<0.001
71793051|NCT03616912|143084936|SUPERIORITY||Odds Ratio (OR)|0.96||||0.839|TWO_SIDED|95.0|0.63|1.45|||Regression, Logistic|||||1.45|0.63|0.839
71793052|NCT03616912|143084936|SUPERIORITY||Odds Ratio (OR)|1.19||||0.391|TWO_SIDED|95.0|0.8|1.79|||Regression, Logistic|||||1.79|0.80|0.391
71793053|NCT03616912|143084938|SUPERIORITY||Odds Ratio (OR)|0.94||||0.82|TWO_SIDED|95.0|0.53|1.66|||Regression, Logistic|||||1.66|0.53|0.820
71793054|NCT03616912|143084938|SUPERIORITY||Odds Ratio (OR)|1.18||||0.565|TWO_SIDED|95.0|0.67|2.08|||Regression, Logistic|||||2.08|0.67|0.565
71793055|NCT03616912|143084939|SUPERIORITY||LS Mean Difference Final Values|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.598|TWO_SIDED|95.0|-0.52|0.3|||Mixed Models Analysis|||||0.30|-0.52|0.598
71672681|NCT02105987|142863666|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.002|TWO_SIDED|95.0|0.85|0.96||Osteocalcin|ANCOVA|||||0.96|0.85|0.002
71672682|NCT02105987|142863666|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|-0.09||||0.001|TWO_SIDED|95.0|-0.15|-0.04||Procollagen 1 n-terminal propeptide|ANCOVA|||||-0.04|-0.15|0.001
71672683|NCT02105987|142863666|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96||Type I collagen c-telopeptides|ANCOVA|||||0.96|0.86|0.001
71672684|NCT02105987|142863667|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.57|0.72||Fatty acid binding protein 2|ANCOVA|||||0.72|0.57|<0.001
71672685|NCT02105987|142863667|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.08||||0.311|TWO_SIDED|95.0|0.93|1.24||Interleukin 6|ANCOVA|||||1.24|0.93|0.311
71672686|NCT02105987|142863667|SUPERIORITY_OR_OTHER||Geometric Mean ratio|0.92|||<|0.001|TWO_SIDED|95.0|0.89|0.96||Soluble CD14|ANCOVA|||||0.96|0.89|<0.001
71672687|NCT02105987|142863667|SUPERIORITY_OR_OTHER||Geometric Mean ratio|1.01||||0.742|TWO_SIDED|95.0|0.95|1.08||Soluble vasc cell adhesion molecule 1|ANCOVA|||||1.08|0.95|0.742
71672688|NCT02105987|142863668|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.999|TWO_SIDED|95.0|0.84|1.19|||ANCOVA|||||1.19|0.84|0.999
71672689|NCT02105987|142863669|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.0||||0.981|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|||||1.10|0.91|0.981
71672690|NCT02105987|142863670|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.64|TWO_SIDED|95.0|0.85|1.11|||ANCOVA|||||1.11|0.85|0.640
71672691|NCT02105987|142863671|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97||||0.645|TWO_SIDED|95.0|0.87|1.09|||ANCOVA|||||1.09|0.87|0.645
71672692|NCT02105987|142863672|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.577|TWO_SIDED|95.0|0.97|1.06|||ANCOVA|||||1.06|0.97|0.577
71672693|NCT02105987|142863673|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01||||0.687|TWO_SIDED|95.0|0.98|1.03|||ANCOVA|||||1.03|0.98|0.687
71672694|NCT01420068|142863679|SUPERIORITY||Mean Difference (Net)|0.31||||0.84|TWO_SIDED|95.0|-2.74|3.37||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline weight as covariates.||||3.37|-2.74|0.840
71793056|NCT03616912|143084939|SUPERIORITY||LS Mean Difference Final Values|-0.09|STANDARD_ERROR_OF_MEAN|0.21||0.674|TWO_SIDED|95.0|-0.5|0.32|||Mixed Models Analysis|||||0.32|-0.50|0.674
71793057|NCT03616912|143084940|SUPERIORITY||LS Mean Difference Final Values|0.02|STANDARD_ERROR_OF_MEAN|0.85||0.979|TWO_SIDED|95.0|-1.65|1.7|||Mixed Models Analysis|||||1.70|-1.65|0.979
71793058|NCT03616912|143084940|SUPERIORITY||LS Mean Difference Final Values|-0.36|STANDARD_ERROR_OF_MEAN|0.86||0.678|TWO_SIDED|95.0|-2.03|1.32|||Mixed Models Analysis|||||1.32|-2.03|0.678
71793059|NCT03616912|143084941|SUPERIORITY||Odds Ratio (OR)|1.02||||0.965|TWO_SIDED|95.0|0.43|2.42|||Regression, Logistic|||||2.42|0.43|0.965
71793060|NCT03616912|143084941|SUPERIORITY||Odds Ratio (OR)|1.22||||0.661|TWO_SIDED|95.0|0.51|2.92|||Regression, Logistic|||||2.92|0.51|0.661
71793061|NCT03616912|143084942|SUPERIORITY||LS Mean Difference Final Values|0.24|STANDARD_ERROR_OF_MEAN|0.43||0.578|TWO_SIDED|95.0|-0.61|1.08|||Mixed Models Analysis|||||1.08|-0.61|0.578
71793062|NCT03616912|143084942|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.433||0.309|TWO_SIDED|95.0|-1.29|0.41|||Mixed Models Analysis|||||0.41|-1.29|0.309
71793063|NCT03616912|143084943|SUPERIORITY||LS Mean Difference Final Values|-0.29|STANDARD_ERROR_OF_MEAN|0.277||0.287|TWO_SIDED|95.0|-0.84|0.25|||Mixed Models Analysis|||||0.25|-0.84|0.287
71793064|NCT03616912|143084943|SUPERIORITY||LS Mean Difference Final Values|-0.44|STANDARD_ERROR_OF_MEAN|0.278||0.113|TWO_SIDED|95.0|-0.99|0.11|||Mixed Models Analysis|||||0.11|-0.99|0.113
71793065|NCT01856790|143084946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.05
71793066|NCT01856790|143084947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.002
71793067|NCT01856790|143084949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.97
71793068|NCT01856790|143084953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon Matched Pairs signed rank tests|||||||.001
71793069|NCT01856790|143084954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Wilcoxon Matched Pairs signed rank tests|||||||0.005
71793070|NCT01124604|143084956|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||||95.0|-1.04|0.8|||||Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.|||0.80|-1.04|
71793071|NCT04091646|143084973|SUPERIORITY||Odds Ratio (OR)|4.95|||<|0.0001|TWO_SIDED|95.0|2.51|9.76|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||9.76|2.51|<0.0001
71793072|NCT04091646|143084974|SUPERIORITY||Odds Ratio (OR)|3.31||||0.0033|TWO_SIDED|95.0|1.46|7.52|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 2 Odds Ratio||7.52|1.46|0.0033
71672695|NCT01420068|142863680|SUPERIORITY||Mean Difference (Net)|0.69||||0.303|TWO_SIDED|95.0|-0.63|2.02||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline height as covariates.||||2.02|-0.63|0.303
71672696|NCT01420068|142863681|SUPERIORITY||Mean Difference (Net)|0.03||||0.957|TWO_SIDED|95.0|-1.06|1.12||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline BMI as covariates.||||1.12|-1.06|0.957
71793073|NCT04091646|143084974|SUPERIORITY||Odds Ratio (OR)|3.78||||0.0002|TWO_SIDED|95.0|1.94|7.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with multiple imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|IGA Success at Week 4 Odds Ratio||7.38|1.94|0.0002
71793074|NCT04091646|143084975|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Erythema Score||||<0.0001
71793075|NCT04091646|143084975|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Erythema Score||||<0.0001
71793076|NCT04091646|143084975|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Erythema Score||||<0.0001
71793077|NCT04091646|143084976|SUPERIORITY||Odds Ratio (OR)|5.05||||0.0065|TWO_SIDED|95.0|1.49|17.13|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 2||17.13|1.49|0.0065
71793078|NCT04091646|143084976|SUPERIORITY||Odds Ratio (OR)|5.36||||0.0002|TWO_SIDED|95.0|2.15|13.38|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 4||13.38|2.15|0.0002
71793079|NCT04091646|143084976|SUPERIORITY||Odds Ratio (OR)|3.15||||0.0021|TWO_SIDED|95.0|1.5|6.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data||Erythema Success at Week 8||6.63|1.50|0.0021
71793080|NCT04091646|143084977|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 2 Scaling Score||||<0.0001
71793081|NCT04091646|143084977|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 4 Scaling Score||||<0.0001
71793082|NCT04091646|143084977|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 8 Scaling Score||||<0.0001
71793083|NCT04091646|143084978|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0759|TWO_SIDED|95.0|0.9|4.33|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 2||4.33|0.90|0.0759
71838759|NCT05604508|143186098|OTHER||Odds Ratio (OR)|0.735|||||TWO_SIDED|95.0|0.347|1.553|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions|||1.553|0.347|
71838760|NCT05604508|143186098|OTHER||Odds Ratio (OR)|0.471|||||TWO_SIDED|95.0|0.234|0.947|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline cigarette use intentions.|||0.947|0.234|
71838761|NCT05604508|143186099|OTHER||Odds Ratio (OR)|1.503|||||TWO_SIDED|95.0|0.727|3.107|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||3.107|0.727|
71793084|NCT04091646|143084978|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0122|TWO_SIDED|95.0|1.18|4.61|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 4||4.61|1.18|0.0122
71793085|NCT04091646|143084978|SUPERIORITY||Odds Ratio (OR)|3.37||||0.0003|TWO_SIDED|95.0|1.74|6.55|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|Scaling Success at Week 8||6.55|1.74|0.0003
71793086|NCT04091646|143084980|SUPERIORITY||Odds Ratio (OR)|3.62||||0.0007|TWO_SIDED|95.0|1.72|7.63|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 2||7.63|1.72|0.0007
71793087|NCT04091646|143084980|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0009|TWO_SIDED|95.0|1.63|6.68|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 4||6.68|1.63|0.0009
71793088|NCT04091646|143084980|SUPERIORITY||Odds Ratio (OR)|3.19||||0.0007|TWO_SIDED|95.0|1.6|6.35|||Cochran-Mantel-Haenszel|Stratification by pooled study site and baseline IGA per randomization with no imputation of missing data|Common OR stratified by pooled study site and baseline IGA per randomization with no imputation of missing data.|WI-NRS Success at Week 8||6.35|1.60|0.0007
71838762|NCT05604508|143186099|OTHER||Odds Ratio (OR)|0.878|||||TWO_SIDED|95.0|0.398|1.938|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline vaping intentions|||1.938|0.398|
71672697|NCT01420068|142863683|SUPERIORITY||Mean Difference (Net)|0.02||||0.992|TWO_SIDED|95.0|-3.29|3.33||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||3.33|-3.29|0.992
71672698|NCT01420068|142863683|SUPERIORITY||Mean Difference (Net)|-3.06||||0.215|TWO_SIDED|95.0|-8.22|2.1||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||2.10|-8.22|0.215
71793089|NCT02066467|143084985|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
71793090|NCT02066467|143084987|OTHER||||||<|0.0001|||||||exact binominal methodology|||||||<0.0001
71793091|NCT00456521|143084988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.21|||<|0.001||95.0|-5.56|-2.86|||ANCOVA|||||-2.86|-5.56|<0.001
71793092|NCT00456521|143084989|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.89|||<|0.001||95.0|2.02|4.13|||Regression, Logistic|||||4.13|2.02|<0.001
71793093|NCT00456521|143084990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|1.95|4.37|||Regression, Logistic|||||4.37|1.95|<0.001
71793094|NCT00456521|143084991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.21|||<|0.001|TWO_SIDED|95.0|-4.82|-1.6|||ANCOVA|||||-1.60|-4.82|<0.001
71793095|NCT00456521|143084992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.11||||0.004|TWO_SIDED||||||ANCOVA|||||||0.004
71793096|NCT00456521|143084993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.53||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
71793097|NCT00456521|143084994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.23|||<|0.001|TWO_SIDED|95.0|1.52|4.95|||ANCOVA|||||4.95|1.52|<0.001
71793098|NCT00456521|143084995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.14||||0.001|TWO_SIDED|95.0|1.23|5.04|||ANCOVA|||||5.04|1.23|0.001
71793099|NCT00456521|143084996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.37||||0.003|TWO_SIDED||||||ANCOVA|||||||0.003
71793100|NCT00456521|143084997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.98||||0.165|TWO_SIDED||||||ANCOVA|||||||0.165
71793101|NCT00456521|143084998|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.28|||||TWO_SIDED|95.0|-3.34|0.79||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.79|-3.34|
71793102|NCT00456521|143084999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|||||TWO_SIDED|95.0|-7.26|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-7.26|
71793103|NCT00456521|143085000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|||||TWO_SIDED|95.0|0.97|4.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.14|0.97|
71793104|NCT00456521|143085001|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|0.25|2.49||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.49|0.25|
71793105|NCT00456521|143085002|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.7|0.87||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.87|-0.70|
71838763|NCT05604508|143186100|OTHER||Odds Ratio (OR)|0.619|||||TWO_SIDED|95.0|0.295|1.301|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, and baseline smokeless use intentions|||1.301|0.295|
71838764|NCT05604508|143186100|OTHER||Odds Ratio (OR)|0.489|||||TWO_SIDED|95.0|0.237|1.006|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco, baseline smokeless use intentions|||1.006|0.237|
71793106|NCT00456521|143085003|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.85|0.63||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.63|-0.85|
71793107|NCT00456521|143085004|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.78|0.6||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.60|-0.78|
71793108|NCT00456521|143085005|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.29|||||TWO_SIDED|95.0|-9.16|-1.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-1.42|-9.16|
71793109|NCT02596854|143085026|NON_INFERIORITY|α=0.025 with a margin of Δ=0.5 were used for non-inferiority testing|Median Difference (Net)|-0.428|STANDARD_ERROR_OF_MEAN|0.3522|<|0.001|TWO_SIDED|95.0|-0.428|-0.269||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)||Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.|Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S \> -Δ.|To mitigate possible bias, the hypothesis test was executed via pre-programmed SAS module, which does not show the data for individual synthetic and conventional group values. The data for these individual groups is thus not currently available as part of the study report held by the sponsor or submitted to FDA. Thus, this data cannot be presented without additional analysis (re-programming) of the original SAS used to perform the study. Data were only reported as the difference between synthetic - conventional to determine non-inferiority, and data for individual crossovers (synthetic vs. conventional) were not calculated.The raw conventional scan images and those post-processed with the research software were combined as pre-specified in the study protocol|-0.269|-0.428|<0.001
71793110|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.14|STANDARD_ERROR_OF_MEAN|0.037||0.1351|TWO_SIDED|95.0|0.96|1.35|||ANOVA|||CREM; Placebo vs GSK256066 1 mcg||1.35|0.96|0.1351
71793111|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.037||0.0383|TWO_SIDED|95.0|1.01|1.41|||ANOVA|||CREM; Placebo vs GSK256066 10 mcg||1.41|1.01|0.0383
71838765|NCT05604508|143186101|OTHER||Odds Ratio (OR)|1.428|||||TWO_SIDED|95.0|0.72|2.832|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.832|0.720|
71838766|NCT05604508|143186101|OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.681|2.96|||||Adjusted for age, gender, race, socioeconomic status, lifetime tobacco use, baseline LCC use intentions|||2.960|0.681|
71838767|NCT04971681|143186139|SUPERIORITY||||||<|0.27|||||||t-test, 2 sided|||||||<0.27
71838768|NCT04971681|143186140|SUPERIORITY||||||<|0.1|||||||t-test, 2 sided|||||||<0.10
71892799|NCT00144170|143306861|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.0||||0.0001|TWO_SIDED|95.0|13.3|24.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.7|13.3|0.0001
71793112|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.2|STANDARD_ERROR_OF_MEAN|0.037||0.0325|TWO_SIDED|95.0|1.02|1.43|||ANOVA|||CREM; Placebo vs GSK256066 50 mcg||1.43|1.02|0.0325
71793113|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.42|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|1.2|1.68|||ANOVA|||CREM; Placebo vs GSK256066 200 mcg||1.68|1.20|<0.0001
71793114|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.45|STANDARD_ERROR_OF_MEAN|0.049||0.0015|TWO_SIDED|95.0|1.16|1.82|||ANOVA|||DUSP1; Placebo vs GSK256066 1 mcg||1.82|1.16|0.0015
71793115|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.049||0.0002|TWO_SIDED|95.0|1.24|1.93|||ANOVA|||DUSP1; Placebo vs GSK256066 10 mcg||1.93|1.24|0.0002
71892800|NCT00144170|143306862|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7||||0.0001|TWO_SIDED|95.0|13.0|24.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||24.4|13.0|0.0001
71793116|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|1.38|2.17|||ANOVA|||DUSP1; Placebo vs GSK256066 50 mcg||2.17|1.38|<0.0001
71793117|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.75|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|1.4|2.18|||ANOVA|||DUSP1; Placebo vs GSK256066 200 mcg||2.18|1.40|<0.0001
71793118|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.49|STANDARD_ERROR_OF_MEAN|0.043||0.0001|TWO_SIDED|95.0|1.22|1.81|||ANOVA|||FOSL2; Placebo vs GSK256066 1 mcg||1.81|1.22|0.0001
71793119|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.52|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.25|1.85|||ANOVA|||FOSL2; Placebo vs GSK256066 10 mcg||1.85|1.25|<0.0001
71793120|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.68|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.38|2.05|||ANOVA|||FOSL2; Placebo vs GSK256066 50 mcg||2.05|1.38|<0.0001
71793121|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|1.28|1.89|||ANOVA|||FOSL2; Placebo vs GSK256066 200 mcg||1.89|1.28|<0.0001
71793122|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.064||0.0034|TWO_SIDED|95.0|1.16|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 1 mcg||2.07|1.16|0.0034
71793123|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.55|STANDARD_ERROR_OF_MEAN|0.063||0.0029|TWO_SIDED|95.0|1.17|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 10 mcg||2.07|1.17|0.0029
71793124|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.74|STANDARD_ERROR_OF_MEAN|0.064||0.0003|TWO_SIDED|95.0|1.3|2.33|||ANOVA|||IRS2; Placebo vs GSK256066 50 mcg||2.33|1.30|0.0003
71793125|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.56|STANDARD_ERROR_OF_MEAN|0.063||0.0027|TWO_SIDED|95.0|1.17|2.08|||ANOVA|||IRS2; Placebo vs GSK256066 200 mcg||2.08|1.17|0.0027
71793126|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.54|STANDARD_ERROR_OF_MEAN|0.092||0.0448|TWO_SIDED|95.0|1.01|2.34|||ANOVA|||NR4A2; Placebo vs GSK256066 1 mcg||2.34|1.01|0.0448
71793127|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.87|STANDARD_ERROR_OF_MEAN|0.091||0.0033|TWO_SIDED|95.0|1.24|2.83|||ANOVA|||NR4A2; Placebo vs GSK256066 10 mcg||2.83|1.24|0.0033
71793128|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|2.16|STANDARD_ERROR_OF_MEAN|0.092||0.0004|TWO_SIDED|95.0|1.42|3.3|||ANOVA|||NR4A2; Placebo vs GSK256066 50 mcg||3.30|1.42|0.0004
71793129|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|2.03|STANDARD_ERROR_OF_MEAN|0.091||0.001||95.0|1.34|3.08|||ANOVA|||NR4A2; Placebo vs GSK256066 200 mcg||3.08|1.34|0.0010
71793130|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.03|STANDARD_ERROR_OF_MEAN|0.072||0.8718|TWO_SIDED|95.0|0.74|1.43|||ANOVA|||PDE4A; Placebo vs GSK256066 1 mcg||1.43|0.74|0.8718
71793131|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.18|STANDARD_ERROR_OF_MEAN|0.071||0.3078|TWO_SIDED|95.0|0.86|1.63|||ANOVA|||PDE4A; Placebo vs GSK256066 10 mcg||1.63|0.86|0.3078
71793132|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.19|STANDARD_ERROR_OF_MEAN|0.072||0.2909|TWO_SIDED|95.0|0.86|1.66|||ANOVA|||PDE4A; Placebo vs GSK256066 50 mcg||1.66|0.86|0.2909
71793133|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.38|STANDARD_ERROR_OF_MEAN|0.071||0.0539|TWO_SIDED|95.0|0.99|1.91|||ANOVA|||PDE4A; Placebo vs GSK256066 200 mcg||1.91|0.99|0.0539
71793134|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.06|STANDARD_ERROR_OF_MEAN|0.081||0.7393|TWO_SIDED|95.0|0.74|1.54|||ANOVA|||RGS1; Placebo vs GSK256066 1 mcg||1.54|0.74|0.7393
71793135|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.21|STANDARD_ERROR_OF_MEAN|0.08||0.2967|TWO_SIDED|95.0|0.84|1.74|||ANOVA|||RGS1; Placebo vs GSK256066 10 mcg||1.74|0.84|0.2967
71793136|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.081||0.0934|TWO_SIDED|95.0|0.95|1.98|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||1.98|0.95|0.0934
71793137|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|1.37|STANDARD_ERROR_OF_MEAN|0.08||0.0919|TWO_SIDED|95.0|0.95|1.97|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||1.97|0.95|0.0919
71793138|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|2.72|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.11|3.51|||ANOVA|||SNF1LK; Placebo vs GSK256066 1 mcg||3.51|2.11|<0.0001
71892801|NCT00144170|143306863|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.2||||0.0001|TWO_SIDED|95.0|11.7|22.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.7|11.7|0.0001
71892802|NCT00144170|143306864|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.1||||0.0001|TWO_SIDED|95.0|11.7|22.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.4|11.7|0.0001
71793139|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|3.04|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.37|3.9|||ANOVA|||SNF1LK; Placebo vs GSK256066 10 mcg||3.90|2.37|<0.0001
71793140|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|3.28|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|2.54|4.23|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg||4.23|2.54|<0.0001
71793141|NCT00464568|143085060|SUPERIORITY_OR_OTHER||Treatment Ratios|3.32|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|2.59|4.27|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg||4.27|2.59|<0.0001
71793142|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.5545|STANDARD_DEVIATION|7.79598||0.647226|||||||Mixed effects analysis of variance model|||Placebo vs GSK256066 1 mcg: VASP||||0.647226
71793143|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|-0.3816|STANDARD_DEVIATION|9.00754||0.95084|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: VASP||||0.95084
71793144|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|0.0256|STANDARD_DEVIATION|9.24118||0.53499|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 50 mcg: VASP||||0.53499
71793145|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.3371|STANDARD_DEVIATION|7.5459||0.81527|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: VASP||||0.81527
71892803|NCT00144170|143306865|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.3||||0.0001|TWO_SIDED|95.0|12.0|22.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||22.5|12.0|0.0001
71672699|NCT01420068|142863684|SUPERIORITY||Mean Difference (Net)|0.62||||0.403|TWO_SIDED|95.0|-0.85|2.09||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||2.09|-0.85|0.403
71672700|NCT01420068|142863684|SUPERIORITY||Mean Difference (Net)|0.92||||0.67|TWO_SIDED|95.0|-3.74|5.57||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||5.57|-3.74|0.670
71672701|NCT01420068|142863685|SUPERIORITY||Mean Difference (Net)|-0.11||||0.86|TWO_SIDED|95.0|-1.29|1.08||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates||Primary Hypertension group (at LT Visit 18 \[Week 104\])||1.08|-1.29|0.860
71672702|NCT01420068|142863685|SUPERIORITY||Mean Difference (Net)|-1.17||||0.32|TWO_SIDED|95.0|-3.66|1.32||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates.||Secondary hypertension group (at LT Visit 19 \[Week 156\])||1.32|-3.66|0.320
71672703|NCT04830969|142863690|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.16
71672704|NCT04830969|142863691|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.08
71672705|NCT04830969|142863692|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.14
71672706|NCT04830969|142863692|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.8
71793146|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|-2.8053|STANDARD_DEVIATION|10.88217||0.32998|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 1 mcg: pVASP||||0.32998
71793147|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.6602|STANDARD_DEVIATION|12.30724||0.65729|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: pVASP||||0.65729
71793148|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|0.156|STANDARD_DEVIATION|4.73976||0.89831|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 50 mcg: pVASP||||0.89831
71793149|NCT00464568|143085075|SUPERIORITY_OR_OTHER||Mean treatment difference|-1.5165|STANDARD_DEVIATION|12.70748||0.84479|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: pVASP||||0.84479
71838769|NCT00686335|143186141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_DEVIATION|6.07|||TWO_SIDED|95.0|-13.5|-2.2||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.|Other|As this was an explorative study, no hypothesis testing was performed. All analyses were descriptive.||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.||-2.2|-13.5|
71892804|NCT00144170|143306866|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.4||||0.0001|TWO_SIDED|95.0|11.2|21.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.5|11.2|0.0001
71892805|NCT00144170|143306867|SUPERIORITY_OR_OTHER||Risk Difference (RD)|16.2||||0.0001|TWO_SIDED|95.0|11.1|21.3||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||21.3|11.1|0.0001
71672707|NCT04830969|142863693|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||<0.01
71672708|NCT04830969|142863693|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.09
71672709|NCT04830969|142863694|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
71672710|NCT04830969|142863694|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.03
71672711|NCT04830969|142863695|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||< 0.01
71672712|NCT04830969|142863695|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.09
71672713|NCT04830969|142863696|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
71672714|NCT04830969|142863696|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.86
71672715|NCT04830969|142863696|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||Baseline to 6 months||||0.047
71672716|NCT04830969|142863696|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.75
71672717|NCT04830969|142863697|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||Baseline to 3 months||||0.44
71672718|NCT04830969|142863697|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.22
71672719|NCT04830969|142863697|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Baseline to 6 months||||0.29
71672720|NCT04830969|142863697|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.15
71672721|NCT04830969|142863698|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Baseline to 3 months||||<0.01
71672722|NCT04830969|142863698|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.31
71672723|NCT04830969|142863698|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
71672724|NCT04830969|142863698|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.54
71672725|NCT04830969|142863699|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Baseline to 3 months||||0.01
71672726|NCT04830969|142863699|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.04
71672727|NCT04830969|142863699|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline to 6 months||||0.03
71838770|NCT03461276|143186246|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|A 1-sided t-test with a significance level of 0.025 was employed.||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)."||||<0.0001
71793150|NCT03615326|143085076|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.61|0.87|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.87|0.61|0.0002
71793151|NCT03615326|143085077|SUPERIORITY|The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.67|0.94|||Log Rank|One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.|OS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||0.94|0.67|0.0040
71793152|NCT03615326|143085078|SUPERIORITY|The difference in percentage and its 95% confidence interval (CI) were estimated using the Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).|Difference in Percentage|12.6||||0.0002|TWO_SIDED|95.0|5.6|19.4||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Stratified Miettinen and Nurminen Method|||ORR in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).||19.4|5.6|0.00020
71793153|NCT02864251|143085143|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0528|TWO_SIDED|95.0|0.56|1.0||Log-rank test stratified by PD-L1 expression (\>= 1% vs \<1%/indeterminate/not evaluable), brain metastases (presence vs absence), smoking history (current/former vs never smoker), and prior osimertinib use (yes vs no) from IRT.|Log Rank||Arm A over Arm C Stratified Cox proportional hazard model.|||1.00|0.56|0.0528
71793154|NCT02864251|143085143|SUPERIORITY||Hazard Ratio (HR)|2.07|||||TWO_SIDED|95.0|1.43|2.99|||||Arm B over Arm C Stratified Cox proportional hazard model.|||2.99|1.43|
71793155|NCT02864251|143085144|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.218|TWO_SIDED|95.0|0.62|1.12|||Log Rank||Hazard Ratio (Arm A over Arm C) is based on a stratified Cox proportional hazard model|||1.12|0.62|0.2180
71793156|NCT02864251|143085144|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.75|1.52|||||Hazard Ratio (Arm B over Arm C) is based on a stratified Cox proportional hazard model.|||1.52|0.75|
71793157|NCT02864251|143085145|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.75|2.16|||||Strata adjusted odds ratio (Arm A over Arm C) using Mantel-Haenszel method.|||2.16|0.75|
71793158|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.109|1.535||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95.||1.535|0.109|
71793159|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.43|3.282||||||Univariate Cox regression: Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.282|0.430|
71793160|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.306|2.425||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker c-MET.||2.425|0.306|
71793161|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.164|1.453||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \<median / ≥median) for the biomarker PTEN.||1.453|0.164|
71793162|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.377|3.16||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||3.160|0.377|
71793163|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.409|4.132||||||Univariate Cox regression Hazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||4.132|0.409|
71793164|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.183|||||TWO_SIDED|95.0|0.226|6.197||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||6.197|0.226|
71793165|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.989|||||TWO_SIDED|95.0|0.378|10.47||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||10.470|0.378|
71793166|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Univariate Cox regression Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
71793167|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
71793168|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.743|||||TWO_SIDED|95.0|0.082|6.72||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||6.720|0.082|
71793169|NCT00885755|143085156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073|||||TWO_SIDED|95.0|0.274|4.199||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||4.199|0.274|
71793170|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.12|1.79||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95 HER2.||1.790|0.120|
71793171|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.394|3.518||||||Univariate Cox regressionHazard ratio (Membrane H-Score: \<median / ≥median) for the biomarker IGF1R.||3.518|0.394|
71793172|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.268|2.514||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker c-met.||2.514|0.268|
71793173|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.183|1.768||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: \< median / ≥median) for the marker PTEN.||1.768|0.183|
71793174|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.242|2.733||||||Univariate Cox regression Hazard ratio (Membrane H-Score: \< median / ≥median) for the biomarker HER2.||2.733|0.242|
71793175|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.337|3.632||||||Univariate Cox regressionHazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.||3.632|0.337|
71793176|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.957|||||TWO_SIDED|95.0|0.172|5.336||||||Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||5.336|0.172|
71793177|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.666|||||TWO_SIDED|95.0|0.298|9.305||||||Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||9.305|0.298|
71793178|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.732|||||TWO_SIDED|95.0|0.235|12.783||||||Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.||12.783|0.235|
71838771|NCT03461276|143186246|SUPERIORITY|Additional test|||||<|0.0001||||||1-sided|Wilcoxon (Mann-Whitney)|||||||<0.0001
71838772|NCT03461276|143186246|SUPERIORITY||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|2.96|3.34|||ANCOVA|||The average MΔ of anti-Aβ40 antibody signal between the two treatment groups was compared using an ANCOVA model, using the MΔ anti-Aβ40 antibody signal as the dependent variable, baseline anti-Aβ40 antibody signal (OD in ELISA) as covariate and treatment group and amyloid positivity as fixed effects.||3.34|2.96|<0.0001
71793179|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.||4.968|0.067|
71793180|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.956|||||TWO_SIDED|95.0|0.098|9.319||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.||9.319|0.098|
71793181|NCT00885755|143085159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.292|||||TWO_SIDED|95.0|0.296|5.64||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.||5.640|0.296|
71793182|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.03|||||TWO_SIDED|95.0|0.001|0.641||||||Univariate logistic regression Odds ratio (Positive / Negative) for the biomarker p95 HER 2.||0.641|0.001|
71793183|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.208|||||TWO_SIDED|95.0|0.017|2.6||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\<median) for the biomarker IGF1R.||2.600|0.017|
71793184|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.143|||||TWO_SIDED|95.0|0.169|27.103||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥ median /\<median) for the biomarker c-MET.||27.103|0.169|
71793185|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.875|||||TWO_SIDED|95.0|0.15|23.396||||||Univariate logistic regression Odds ratio (Cytoplasm H-Score: ≥ median /\< median) for the biomarker PTEN.||23.396|0.150|
71793186|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.857|||||TWO_SIDED|95.0|0.091|8.075||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /\< median) for the biomarker HER2.||8.075|0.091|
71793187|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.148|||||TWO_SIDED|95.0|0.012|1.9||||||Univariate logistic regression Odds ratio (PI3K mutation status: WT versus M) for the biomarker PI3K Amino Acids.||1.900|0.012|
71793188|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.053|18.915||||||Univariate logistic regressionOdds ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.||18.915|0.053|
71793189|NCT00885755|143085167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.083|||||TWO_SIDED|95.0|0.004|1.945||||||Univariate logistic regression Odds ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H||1.945|0.004|
71793190|NCT04191382|143085255|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.08|||||TWO_SIDED|95.0|0.72|1.63||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 400 mg versus Letrozole 2.5 mg).||1.63|0.72|
71793191|NCT04191382|143085255|OTHER|Other descriptive analysis|Ratio of Geometric Means|1.42|||||TWO_SIDED|95.0|0.95|2.12||||||Geometric LS-means ratio of proportional change was the ratio of geometric LS-means of the proportional change between groups (Amcenestrant 200 mg versus Letrozole 2.5 mg).||2.12|0.95|
71793192|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0631|TWO_SIDED|95.0|-5.96|0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.16|-5.96|0.0631
71838773|NCT03461276|143186246|SUPERIORITY||||||<|0.0001|||||||t-test, 1 sided|t-test (sensitivity hypothesis). A 1-sided t-test with a significance level of 0.025 was employed.||"1-sided t-test to compare the ABvac40 and placebo groups.~The primary analysis (t-test) was repeated, using the mITT Analysis Set to test the hypothesis:~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) ≤ 1.778~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) - average MΔ anti-Aβ40 (placebo) \> 1.778 The alternative hypothesis was confirmed."||||<0.0001
71793193|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.0008|TWO_SIDED|95.0|-8.33|-2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.20|-8.33|0.0008
71793194|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0188|TWO_SIDED|95.0|-6.73|-0.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.61|-6.73|0.0188
71793195|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.8|-2.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.63|-8.80|0.0003
71793196|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.0177|TWO_SIDED|95.0|-6.77|-0.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.65|-6.77|0.0177
71793197|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.855||95.0|-2.72|3.27||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.27|-2.72|0.8550
71793198|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1719|TWO_SIDED|95.0|-5.08|0.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.91|-5.08|0.1719
71793199|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7469|TWO_SIDED|95.0|-3.49|2.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.50|-3.49|0.7469
71793200|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1001|TWO_SIDED|95.0|-5.55|0.49||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.49|-5.55|0.1001
71793201|NCT00362115|143085270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7294|TWO_SIDED|95.0|-3.52|2.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.47|-3.52|0.7294
71793202|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0111|TWO_SIDED|95.0|-10.84|-1.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.41|-10.84|0.0111
71793203|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-15.51|-6.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.08|-15.51|< 0.0001
71892806|NCT00144170|143306868|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.6||||0.0001|TWO_SIDED|95.0|10.6|20.6||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel|||||20.6|10.6|0.0001
71793204|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.8|||<|0.0001|TWO_SIDED|95.0|-14.53|-5.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.10|-14.53|< 0.0001
71793205|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.02|-7.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.52|-17.02|< 0.0001
71793206|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5||||0.0005|TWO_SIDED|95.0|-13.19|-3.76||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.76|-13.19|0.0005
71793207|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.2768|TWO_SIDED|95.0|-2.06|7.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.17|-2.06|0.2768
71793208|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.3688|TWO_SIDED|95.0|-6.74|2.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.51|-6.74|0.3688
71793209|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1||||0.6293|TWO_SIDED|95.0|-5.75|3.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.48|-5.75|0.6293
71793210|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.1298|TWO_SIDED|95.0|-8.25|1.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.06|-8.25|0.1298
71793211|NCT00362115|143085271|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9315|TWO_SIDED|95.0|-4.41|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.41|0.9315
71793212|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0016|TWO_SIDED|95.0|-13.17|-3.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.09|-13.17|0.0016
71793213|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-15.17|-5.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.09|-15.17|< 0.0001
71793214|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.0001|TWO_SIDED|95.0|-17.8|-7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.72|-17.80|< 0.0001
71793215|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.36|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-16.36|< 0.0001
71892807|NCT00144170|143306869|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71892808|NCT00144170|143306870|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71892809|NCT00144170|143306871|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Log Rank|||||||0.0001
71892810|NCT00144170|143306945|SUPERIORITY_OR_OTHER|||||||0.1026||95.0|||||Log Rank|||||||0.1026
71892811|NCT01564784|143306952|SUPERIORITY_OR_OTHER||Rate difference|51.4|||<|0.0001|TWO_SIDED|97.5|38.4|64.3|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||64.3|38.4|<0.0001
71892812|NCT01564784|143306953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0105|TWO_SIDED|97.5|0.568|0.993|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.993|0.568|0.0105
71892813|NCT01564784|143306954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0021|TWO_SIDED|95.0|0.297|0.809|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.809|0.297|0.0021
71672728|NCT04830969|142863699|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.38
71793216|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7|||<|0.0001|TWO_SIDED|95.0|-15.75|-5.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.63|-15.75|< 0.0001
71793217|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9909|TWO_SIDED|95.0|-4.96|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-4.96|0.9909
71793218|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4213|TWO_SIDED|95.0|-6.96|2.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.92|-6.96|0.4213
71793219|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.0646|TWO_SIDED|95.0|-9.59|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-9.59|0.0646
71793220|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.2107|TWO_SIDED|95.0|-8.15|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-8.15|0.2107
71793221|NCT00362115|143085272|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.3059|TWO_SIDED|95.0|-7.54|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.54|0.3059
71838774|NCT03461276|143186246|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||"The change in anti-Aβ40 antibody signal from baseline to each post-baseline efficacy visit was analyzed using a Mixed-Model Repeated Measures (MMRM), using the mITT Analysis Set.~Dependent variable: change from baseline in anti-Aβ40 antibody signal. Fixed effects: treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity. Covariates: baseline anti-Aβ40 antibody signal and baseline age; Repeated measure: measures within-patient at each visit."||||<0.05
71838775|NCT03461276|143186253|OTHER||||||<|0.001|||||||Mixed Models Analysis|||MMRM - Week 50A||||<0.001
71838776|NCT03461276|143186253|OTHER||||||=|0.047|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.047
71838777|NCT03461276|143186254|OTHER||||||=|0.9936|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9936
71838778|NCT03461276|143186254|OTHER||||||=|0.0391||||||MMRM - Week 6A|Mixed Models Analysis|||MMRM - Week 6A||||= 0.0391
71838779|NCT03461276|143186254|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 10A||||< 0.0001
71838780|NCT03461276|143186254|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 14A||||< 0.0001
71838781|NCT03461276|143186254|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
71838782|NCT03461276|143186254|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
71838783|NCT03461276|143186254|OTHER||||||=|0.0299|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0299
71838784|NCT03461276|143186254|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
71838785|NCT03461276|143186254|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
71838786|NCT03461276|143186254|OTHER||||||=|0.1267|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1267
71838787|NCT03461276|143186254|OTHER|MMRM - Week 104A|||||=|0.2477|||||||Mixed Models Analysis|||||||= 0.2477
71838788|NCT03461276|143186255|OTHER||||||=|0.2151|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.2151
71838789|NCT03461276|143186255|OTHER||||||=|0.0169|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.0169
71838790|NCT03461276|143186255|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.0008
71838791|NCT03461276|143186255|OTHER||||||=|0.0002|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0002
71838792|NCT03461276|143186255|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 18A||||< 0.0001
71838793|NCT03461276|143186255|OTHER||||||=|0.0023|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0023
71838794|NCT03461276|143186255|OTHER||||||=|0.0021|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0021
71838795|NCT03461276|143186255|OTHER||||||=|0.0007|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0007
71838796|NCT03461276|143186255|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.0012
71838797|NCT03461276|143186255|OTHER||||||=|0.0018|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.0018
71838798|NCT03461276|143186255|OTHER||||||=|0.738|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.738
71838799|NCT03461276|143186256|OTHER||||||=|0.7623|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.7623
71838800|NCT03461276|143186256|OTHER||||||=|0.1506|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.1506
71838801|NCT03461276|143186256|OTHER||||||=|0.1071|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.1071
71838802|NCT03461276|143186256|OTHER||||||=|0.0212|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0212
71838803|NCT03461276|143186256|OTHER||||||=|0.0014|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0014
71838804|NCT03461276|143186256|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 24A||||< 0.0001
71838805|NCT03461276|143186256|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 40A||||< 0.0001
71838806|NCT03461276|143186256|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
71838807|NCT03461276|143186256|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
71838808|NCT03461276|143186256|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 77A||||< 0.0001
71793222|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1653|TWO_SIDED|95.0|-5.69|0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.98|-5.69|0.1653
71672729|NCT04830969|142863700|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline to 3 months||||0.02
71793223|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.0151|TWO_SIDED|95.0|-7.5|-0.81||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.81|-7.50|0.0151
71793224|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.048|TWO_SIDED|95.0|-6.7|-0.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.03|-6.70|0.0480
71793225|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0098|TWO_SIDED|95.0|-7.81|-1.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.08|-7.81|0.0098
71793226|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0113|TWO_SIDED|95.0|-7.68|-0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.98|-7.68|0.0113
71793227|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.3416|TWO_SIDED|95.0|-1.68|4.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.84|-1.68|0.3416
71793228|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8973|TWO_SIDED|95.0|-3.49|3.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.06|-3.49|0.8973
71793229|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7292|TWO_SIDED|95.0|-2.69|3.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.84|-2.69|0.7292
71793230|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7646|TWO_SIDED|95.0|-3.79|2.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.79|-3.79|0.7646
71793231|NCT00362115|143085273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8133|TWO_SIDED|95.0|-3.67|2.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.88|-3.67|0.8133
71793232|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-12.51|-4.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.51|-12.51|< 0.0001
71838809|NCT03461276|143186256|OTHER||||||=|0.0251|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0251
71672730|NCT04830969|142863700|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 3 months||||0.18
71672731|NCT04830969|142863700|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline to 6 months||||0.08
71672732|NCT04830969|142863700|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||Baseline to 6 months||||0.41
71672733|NCT04830969|142863701|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.27
71793233|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0001|TWO_SIDED|95.0|-17.31|-8.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.90|-17.31|< 0.0001
71793234|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.27|-7.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.95|-16.27|< 0.0001
71793235|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|||<|0.0001|TWO_SIDED|95.0|-21.07|-12.46||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.46|-21.07|< 0.0001
71793236|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-17.58|-9.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.17|-17.58|< 0.0001
71793237|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.3735|TWO_SIDED|95.0|-2.1|5.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.58|-2.10|0.3735
71793238|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.1668|TWO_SIDED|95.0|-6.91|1.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-6.91|0.1668
71793239|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.3629|TWO_SIDED|95.0|-5.86|2.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.15|-5.86|0.3629
71793240|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0022|TWO_SIDED|95.0|-10.67|-2.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.36|-10.67|0.0022
71793241|NCT00362115|143085274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1303|TWO_SIDED|95.0|-7.18|0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-7.18|0.1303
71838810|NCT03461276|143186257|OTHER||||||=|0.6515|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.6515
71838811|NCT03461276|143186257|OTHER||||||=|0.7447|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.7447
71838812|NCT03461276|143186257|OTHER||||||=|0.4518|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.4518
71838813|NCT03461276|143186257|OTHER||||||=|0.5416|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.5416
71838814|NCT03461276|143186257|OTHER||||||=|0.3504|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.3504
71838815|NCT03461276|143186257|OTHER||||||=|0.2109|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.2109
71838816|NCT03461276|143186257|OTHER||||||=|0.0049|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0049
71838817|NCT03461276|143186257|OTHER||||||=|0.0498|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.0498
71838818|NCT03461276|143186257|OTHER||||||=|0.2181|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2181
71838819|NCT03461276|143186257|OTHER||||||=|0.2087|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2087
71838820|NCT03461276|143186257|OTHER||||||=|0.8599|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8599
71838821|NCT03461276|143186258|OTHER||||||=|0.9469|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9469
71838822|NCT03461276|143186258|OTHER||||||=|0.9063|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.9063
71838823|NCT03461276|143186258|OTHER||||||=|0.3418|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.3418
71838824|NCT03461276|143186258|OTHER||||||=|0.0236|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.0236
71838825|NCT03461276|143186258|OTHER||||||=|0.0012|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.0012
71838826|NCT03461276|143186258|OTHER||||||=|0.0004|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.0004
71838827|NCT03461276|143186258|OTHER||||||=|0.0008|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.0008
71838828|NCT03461276|143186258|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 44A||||< 0.0001
71838829|NCT03461276|143186258|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||MMRM - Week 50A||||< 0.0001
71838830|NCT03461276|143186258|OTHER||||||=|0.1255|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1255
71838831|NCT03461276|143186258|OTHER||||||=|0.4232|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4232
71838832|NCT03461276|143186259|OTHER||||||=|0.9211|||||||Mixed Models Analysis|||MMRM - Week 2A||||= 0.9211
71838833|NCT03461276|143186259|OTHER||||||=|0.2817|||||||Mixed Models Analysis|||MMRM - Week 6A||||= 0.2817
71838834|NCT03461276|143186259|OTHER||||||=|0.2984|||||||Mixed Models Analysis|||MMRM - Week 10A||||= 0.2984
71838835|NCT03461276|143186259|OTHER||||||=|0.8402|||||||Mixed Models Analysis|||MMRM - Week 14A||||= 0.8402
71838836|NCT03461276|143186259|OTHER||||||=|0.4428|||||||Mixed Models Analysis|||MMRM - Week 18A||||= 0.4428
71838837|NCT03461276|143186259|OTHER||||||=|0.4156|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.4156
71672734|NCT04830969|142863702|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.54
71672735|NCT04830969|142863703|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.12
71672736|NCT04830969|142863704|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
71672737|NCT04830969|142863704|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.07
71672738|NCT04830969|142863705|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71672739|NCT04830969|142863705|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.64
71672740|NCT04830969|142863706|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71672741|NCT04830969|142863706|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|used generalized linear models adjusted for baseline CRP||||||0.11
71838838|NCT03461276|143186259|OTHER||||||=|0.8706|||||||Mixed Models Analysis|||MMRM - Week 40A||||= 0.8706
71793242|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4|||<|0.0001|TWO_SIDED|95.0|-8.12|-2.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.72|-8.12|< 0.0001
71793243|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.65|-11.33|< 0.0001
71672742|NCT04830969|142863707|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||at baseline||||0.7
71672743|NCT04830969|142863707|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||6 months||||0.29
71672744|NCT04830969|142863708|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71793244|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-11.52|< 0.0001
71793245|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||<|0.0001|TWO_SIDED|95.0|-13.73|-7.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.91|-13.73|< 0.0001
71838839|NCT03461276|143186259|OTHER||||||=|0.8691|||||||Mixed Models Analysis|||MMRM - Week 44A||||= 0.8691
71838840|NCT03461276|143186259|OTHER||||||=|0.2188|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2188
71672745|NCT01153815|142863721|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Exact Smirnov test|||||||<0.001
71672746|NCT01786993|142863730|SUPERIORITY_OR_OTHER||Event-Free Probability|0.932|||||TWO_SIDED|95.0|0.904|0.951||||||"The hypothesis is formally expressed as:~H0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months \> 75%"||0.951|0.904|
71672747|NCT01786993|142863731|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.|Difference of proportions|-0.049||||0.0131|ONE_SIDED|97.5|-0.138||||normal approximation for binomial dist|||"H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15~Ha: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) - (Non-responder rate in the MPP arm between 3 M randomization and 9 M) \> -0.15~The null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15."|||-0.138|0.0131
71672748|NCT01890122|142863732|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-0.7|-0.278||An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.278|-0.700|< 0.0001
71672749|NCT01890122|142863732|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.108|<|0.0001|TWO_SIDED|95.0|-0.889|-0.467||An ANCOVA model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA|||||-0.467|-0.889|< 0.0001
71672750|NCT02907177|142863761|SUPERIORITY||Treatment effect (rate ratio)|1.27||||0.5252|TWO_SIDED|95.0|0.608|2.654|||Negative binomial regression||Rate ratio is ponesimod 20 mg / DMF versus placebo /DMF|||2.654|0.608|0.5252
71672751|NCT02505217|142863765|SUPERIORITY|||||||0.007|||||||Regression, Cox|||||||0.007
71672752|NCT02712554|142863776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71672753|NCT02712554|142863776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71672754|NCT02712554|142863776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2344|||||||ANOVA|||||||0.2344
71672755|NCT02712554|142863776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4737|||||||ANOVA|||||||0.4737
71672756|NCT02712554|142863776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71672757|NCT02712554|142863776|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71672758|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71672759|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71672760|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1267|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1267
71672761|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1767|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1767
71838841|NCT03461276|143186259|OTHER||||||=|0.1448|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.1448
71838842|NCT03461276|143186259|OTHER||||||=|0.5004|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5004
71838843|NCT03461276|143186260|OTHER||||||=|0.1058|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1058
71838844|NCT03461276|143186260|OTHER||||||=|0.0922|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0922
71838845|NCT03461276|143186261|OTHER||||||=|0.9313|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.9313
71838846|NCT03461276|143186261|OTHER||||||=|0.2243|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2243
71838847|NCT03461276|143186261|OTHER||||||=|0.0952|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.0952
71838848|NCT03461276|143186262|OTHER||||||=|0.3599|||||||Mixed Models Analysis|||MMRM - Week 24A - left||||= 0.3599
71838849|NCT03461276|143186262|OTHER||||||=|0.8913|||||||Mixed Models Analysis|||MMRM - Week 50A - left||||= 0.8913
71838850|NCT03461276|143186262|OTHER||||||=|0.4736|||||||Mixed Models Analysis|||MMRM - Week 104A - left||||= 0.4736
71838851|NCT03461276|143186262|OTHER||||||=|0.9095|||||||Mixed Models Analysis|||MMRM - Week 24A - right||||= 0.9095
71838852|NCT03461276|143186262|OTHER||||||=|0.8744|||||||Mixed Models Analysis|||MMRM - Week 50A - right||||= 0.8744
71838853|NCT03461276|143186262|OTHER||||||=|0.9307|||||||Mixed Models Analysis|||MMRM - Week 104A - right||||= 0.9307
71838854|NCT03461276|143186263|OTHER||||||=|0.3982|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3982
71838855|NCT03461276|143186263|OTHER||||||=|0.7035|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7035
71892814|NCT01564784|143306955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|97.5|0.336|0.602|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.|||0.602|0.336|<0.0001
71892815|NCT01564784|143306956|SUPERIORITY_OR_OTHER||Rate difference|31.6|||<|0.0001|TWO_SIDED|95.0|22.6|40.6|||1-sided p-value based on Chi-square test|If any cell count was \<5, p-value was based on Fisher's exact test||||40.6|22.6|<0.0001
71892816|NCT01564784|143306957|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||||||<0.0001
71672762|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71672763|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71838856|NCT03461276|143186263|OTHER||||||=|0.6334|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6334
71892817|NCT01564784|143306958|SUPERIORITY_OR_OTHER|||||||0.3168|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal at Screening||||0.3168
71892818|NCT01564784|143306958|SUPERIORITY_OR_OTHER|||||||0.216|||||||1-sided p-value based on Chi-Square test|If any cell count is \<5, p-value was based on Fisher's exact test||Abnormal after remission||||0.2160
71672764|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0119|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0119
71838857|NCT03461276|143186264|OTHER||||||=|0.2193|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2193
71838858|NCT03461276|143186264|OTHER||||||=|0.5543|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5543
71838859|NCT03461276|143186265|OTHER||||||=|0.7324|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7324
71838860|NCT03461276|143186265|OTHER||||||=|0.1719|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.1719
71838861|NCT03461276|143186266|OTHER||||||=|0.7977|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7977
71838862|NCT03461276|143186266|OTHER||||||=|0.8828|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8828
71838863|NCT03461276|143186267|OTHER||||||=|0.7954|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.7954
71838864|NCT03461276|143186267|OTHER||||||=|0.5895|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.5895
71838865|NCT03461276|143186268|OTHER||||||=|0.743|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.743
71838866|NCT03461276|143186268|OTHER||||||=|0.832|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.832
71838867|NCT03461276|143186269|OTHER||||||=|0.2283|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2283
71838868|NCT03461276|143186269|OTHER||||||=|0.886|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.886
71838869|NCT03461276|143186270|OTHER||||||=|0.909|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.909
71838870|NCT03461276|143186270|OTHER||||||=|0.8498|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.8498
71838871|NCT03461276|143186271|OTHER||||||=|0.8711|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8711
71838872|NCT03461276|143186271|OTHER||||||=|0.1098|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.1098
71838873|NCT03461276|143186271|OTHER||||||=|0.6179|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.6179
71838874|NCT03461276|143186271|OTHER||||||=|0.3715|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3715
71838875|NCT03461276|143186272|OTHER||||||=|0.8949|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.8949
71838876|NCT03461276|143186272|OTHER||||||=|0.8712|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8712
71838877|NCT03461276|143186272|OTHER||||||=|0.8748|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.8748
71838878|NCT03461276|143186272|OTHER||||||=|0.6402|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6402
71838879|NCT03461276|143186273|OTHER||||||=|0.552|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.552
71838880|NCT03461276|143186273|OTHER||||||=|0.9371|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9371
71838881|NCT03461276|143186273|OTHER||||||=|0.2354|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.2354
71838882|NCT03461276|143186273|OTHER||||||=|0.4608|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.4608
71838883|NCT03461276|143186274|OTHER||||||=|0.3246|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.3246
71838884|NCT03461276|143186274|OTHER||||||=|0.8047|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.8047
71838885|NCT03461276|143186274|OTHER||||||=|0.916|||||||Mixed Models Analysis|||MMRM - Week 77A||||= 0.916
71838886|NCT03461276|143186274|OTHER||||||=|0.9582|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.9582
71838887|NCT03461276|143186275|OTHER||||||=|0.777|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail A||||= 0.777
71838888|NCT03461276|143186275|OTHER||||||=|0.1727|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail A||||= 0.1727
71838889|NCT03461276|143186275|OTHER||||||=|0.0218|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail A||||= 0.0218
71838890|NCT03461276|143186275|OTHER||||||=|0.2789|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail A||||= 0.2789
71838891|NCT03461276|143186275|OTHER||||||=|0.2261|||||||Mixed Models Analysis|||MMRM - Week 24A - Trail B||||= 0.2261
71838892|NCT03461276|143186275|OTHER||||||=|0.9743|||||||Mixed Models Analysis|||MMRM - Week 50A - Trail B||||= 0.9743
71838893|NCT03461276|143186275|OTHER||||||=|0.2556|||||||Mixed Models Analysis|||MMRM - Week 77A - Trail B||||= 0.2556
71892819|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.0139|TWO_SIDED|95.0|1.4|12.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Physical Functioning||12.3|1.4|0.0139
71672765|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0025
71672766|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1679
71672767|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0318|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0318
71672768|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||0.0002
71672769|NCT02712554|142863780|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<.0001
71793246|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001|TWO_SIDED|95.0|-12.31|-6.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.64|-12.31|< 0.0001
71793247|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1249|TWO_SIDED|95.0|-0.56|4.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.61|-0.56|0.1249
71793248|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.4542|TWO_SIDED|95.0|-3.79|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-3.79|0.4542
71793249|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.3574|TWO_SIDED|95.0|-3.97|1.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.44|-3.97|0.3574
71793250|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0184|TWO_SIDED|95.0|-6.18|-0.57||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.57|-6.18|0.0184
71672770|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71672771|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71672772|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0858|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0858
71672773|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2877|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2877
71672774|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71672775|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71672776|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0009
71793251|NCT00362115|143085275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.145|TWO_SIDED|95.0|-4.77|0.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.70|-4.77|0.1450
71793252|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9||||0.0009|TWO_SIDED|95.0|-12.46|-3.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.26|-12.46|0.0009
71793253|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-18.46|-8.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.77|-18.46|< 0.0001
71793254|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-17.21|-7.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.63|-17.21|< 0.0001
71838894|NCT03461276|143186275|OTHER||||||=|0.1008|||||||Mixed Models Analysis|||MMRM - Week 104A - Trail B||||= 0.1008
71838895|NCT03461276|143186276|OTHER||||||=|0.6189|||||||Mixed Models Analysis|||MMRM - Week 24A||||= 0.6189
71838896|NCT03461276|143186276|OTHER||||||=|0.6937|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.6937
71838897|NCT03461276|143186276|OTHER||||||=|0.6981|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.6981
71838898|NCT03461276|143186278|OTHER||||||=|0.2863|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.2863
71838899|NCT03461276|143186278|OTHER||||||=|0.3703|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3703
71838900|NCT03461276|143186279|OTHER||||||=|0.9663|||||||Mixed Models Analysis|||MMRM - Week 50A||||= 0.9663
71838901|NCT03461276|143186279|OTHER||||||=|0.3843|||||||Mixed Models Analysis|||MMRM - Week 104A||||= 0.3843
71838902|NCT03461276|143186280|SUPERIORITY||||||<|0.0001||||||A 1-sided t-test with a significance level of 0.025 was employed.|t-test, 1 sided|||"The trial was considered successfully confirmatory regarding efficacy (immunogenicity) of ABvac40 if the average MΔ of anti-Aβ40 antibody signal (OD in ELISA) in the ABvac40 group was significantly greater than the average MΔ of anti-Aβ40 antibody signal in the Placebo group. i.e.~* Null hypothesis: average MΔ anti-Aβ40 (ABvac40) ≤ average MΔ anti-Aβ40 (placebo).~* Alternative hypothesis: average MΔ anti-Aβ40 (ABvac40) \> average MΔ anti-Aβ40 (placebo)"||||< 0.0001
71838903|NCT03461276|143186280|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71838904|NCT03461276|143186280|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|3.02|3.4|||ANCOVA|||||3.4|3.02|< 0.0001
71838905|NCT03848065|143186300|OTHER||Difference in Percentages|17.8||||0.004|TWO_SIDED|95.0|9.0|31.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Erythema (Redness)||31.4|9.0|0.004
71838906|NCT03848065|143186300|OTHER||Difference in Percentages|4.7||||0.15|TWO_SIDED|95.0|-3.7|15.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Erythema (Redness)||15.5|-3.7|0.150
71672777|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||0.0001
71672778|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1130
71672779|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0575|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0575
71672780|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<.0001
71672781|NCT02712554|142863781|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<.0001
71793255|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.83|-12.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-12.92|-22.83|< 0.0001
71793256|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.52|-8.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.84|-18.52|< 0.0001
71793257|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9424|TWO_SIDED|95.0|-4.25|4.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.58|-4.25|0.9424
71793258|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0189|TWO_SIDED|95.0|-10.26|-0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.93|-10.26|0.0189
71793259|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0612|TWO_SIDED|95.0|-9.01|0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.21|-9.01|0.0612
71793260|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.0001|TWO_SIDED|95.0|-14.63|-5.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.07|-14.63|< 0.0001
71793261|NCT00362115|143085276|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0175|TWO_SIDED|95.0|-10.33|-1.0||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.00|-10.33|0.0175
71838907|NCT03848065|143186300|OTHER||Difference in Percentages|-13.1||||0.054|TWO_SIDED|95.0|-27.6|0.2|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Erythema (Redness)||0.2|-27.6|0.054
71838908|NCT03848065|143186300|OTHER||Difference in Percentages|13.1||||0.091|TWO_SIDED|95.0|-2.3|28.8|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Induration (Hard Lump)||28.8|-2.3|0.091
71672782|NCT02712554|142863782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71672783|NCT02712554|142863782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71672784|NCT02712554|142863782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4025|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4025
71793262|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0108|TWO_SIDED|95.0|-7.26|-0.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.95|-7.26|0.0108
71793263|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||<|0.0001|TWO_SIDED|95.0|-11.16|-4.55||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-11.16|< 0.0001
71793264|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001|TWO_SIDED|95.0|-11.82|-5.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.26|-11.82|< 0.0001
71793265|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-13.98|-7.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.20|-13.98|< 0.0001
71793266|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||<|0.0001|TWO_SIDED|95.0|-12.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.90|-12.52|< 0.0001
71793267|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.306|TWO_SIDED|95.0|-1.45|4.59||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.59|-1.45|0.3060
71793268|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.1823|TWO_SIDED|95.0|-5.37|1.02||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.02|-5.37|0.1823
71793269|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.0751|TWO_SIDED|95.0|-6.01|0.29||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.29|-6.01|0.0751
71793270|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0034|TWO_SIDED|95.0|-8.18|-1.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.64|-8.18|0.0034
71838909|NCT03848065|143186300|OTHER||Difference in Percentages|-9.1||||0.044|TWO_SIDED|95.0|-21.2|-0.4|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Induration (Hard Lump)||-0.4|-21.2|0.044
71838910|NCT03848065|143186300|OTHER||Difference in Percentages|-22.2||||0.001|TWO_SIDED|95.0|-36.4|-12.5|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Induration (Hard Lump)||-12.5|-36.4|0.001
71838911|NCT03848065|143186300|OTHER||Difference in Percentages|9.7||||0.333|TWO_SIDED|95.0|-10.0|28.9|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Pain||28.9|-10.0|0.333
71672785|NCT02712554|142863782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3184|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.3184
71672786|NCT02712554|142863782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71672787|NCT02712554|142863782|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71892820|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.4||||0.0065|TWO_SIDED|95.0|3.2|19.5|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Role Functioning||19.5|3.2|0.0065
71793271|NCT00362115|143085277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0306|TWO_SIDED|95.0|-6.72|-0.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.33|-6.72|0.0306
71793272|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1||||0.0061|TWO_SIDED|95.0|-13.9|-2.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.33|-13.90|0.0061
71793273|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.5||||0.0002|TWO_SIDED|95.0|-17.56|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-17.56|0.0002
71793274|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-18.34|-6.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.28|-18.34|< 0.0001
71793275|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|||<|0.0001|TWO_SIDED|95.0|-23.75|-11.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.34|-23.75|< 0.0001
71793276|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.0001|TWO_SIDED|95.0|-19.86|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-19.86|< 0.0001
71793277|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.9355|TWO_SIDED|95.0|-5.74|5.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.28|-5.74|0.9355
71793278|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.2223|TWO_SIDED|95.0|-9.41|2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.20|-9.41|0.2223
71793279|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1328|TWO_SIDED|95.0|-10.19|1.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.35|-10.19|0.1328
71892821|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.3307|TWO_SIDED|95.0|-6.9|2.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Emotional Functioning||2.3|-6.9|0.3307
71672788|NCT02712554|142863783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
71793280|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7||||0.0016|TWO_SIDED|95.0|-15.61|-3.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.70|-15.61|0.0016
71793281|NCT00362115|143085278|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0437|TWO_SIDED|95.0|-11.7|-0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.17|-11.70|0.0437
71793282|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0417|TWO_SIDED|95.0|-8.39|-0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-8.39|0.0417
71793283|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0053|TWO_SIDED|95.0|-10.44|-1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.84|-10.44|0.0053
71793284|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8||||0.0004|TWO_SIDED|95.0|-12.12|-3.56||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.56|-12.12|0.0004
71793285|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|||<|0.0001|TWO_SIDED|95.0|-13.97|-5.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.16|-13.97|< 0.0001
71793286|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.6|-5.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-13.60|< 0.0001
71793287|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6372|TWO_SIDED|95.0|-2.97|4.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.85|-2.97|0.6372
71892822|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.1904|TWO_SIDED|95.0|-1.4|7.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Cognitive Functioning||7.0|-1.4|0.1904
71672789|NCT02712554|142863783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
71793288|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.6588|TWO_SIDED|95.0|-5.05|3.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.20|-5.05|0.6588
71793289|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2082|TWO_SIDED|95.0|-6.72|1.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.47|-6.72|0.2082
71793290|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0437|TWO_SIDED|95.0|-8.57|-0.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.12|-8.57|0.0437
71838912|NCT03848065|143186300|OTHER||Difference in Percentages|-3.2||||0.76|TWO_SIDED|95.0|-23.4|17.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Pain||17.2|-23.4|0.760
71838913|NCT03848065|143186300|OTHER||Difference in Percentages|-13.0||||0.205|TWO_SIDED|95.0|-32.2|7.1|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Pain||7.1|-32.2|0.205
71838914|NCT03848065|143186300|OTHER||Difference in Percentages|13.0||||0.128|TWO_SIDED|95.0|-3.9|29.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Injection Site Swelling||29.7|-3.9|0.128
71838915|NCT03848065|143186300|OTHER||Difference in Percentages|-2.0||||0.779|TWO_SIDED|95.0|-17.0|13.0|||Miettinen & Nurminen method||Difference = % V114-SC minus % PCV13-SC|Injection Site Swelling||13.0|-17.0|0.779
71838916|NCT03848065|143186300|OTHER||Difference in Parentages|-15.0||||0.076|TWO_SIDED|95.0|-31.5|1.7|||Miettinen & Nurminen method||Difference = % V114-IM minus % PCV13-SC|Injection Site Swelling||1.7|-31.5|0.076
71838917|NCT03848065|143186301|OTHER||Difference in Percentages|-10.6||||0.282|TWO_SIDED|95.0|-29.1|8.7|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Decreased Appetite (Appetite Loss)||8.7|-29.1|0.282
71838918|NCT03848065|143186301|OTHER||Difference in Percentages|-9.9||||0.317|TWO_SIDED|95.0|-28.7|9.5|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Decreased Appetite (Appetite Loss)||9.5|-28.7|0.317
71838919|NCT03848065|143186301|OTHER||Difference in Percentages|0.7||||0.948|TWO_SIDED|95.0|-19.2|20.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Decreased Appetite (Appetite Loss)||20.4|-19.2|0.948
71838920|NCT03848065|143186301|OTHER||Difference in Percentages|10.5||||0.303|TWO_SIDED|95.0|-9.4|29.6|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Somnolence (Drowsiness)||29.6|-9.4|0.303
71672790|NCT02712554|142863783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2628|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2628
71672791|NCT02712554|142863783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2262|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.2262
71838921|NCT03848065|143186301|OTHER||Difference in Percentages|-4.0||||0.681|TWO_SIDED|95.0|-22.6|15.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Somnolence (Drowsiness)||15.0|-22.6|0.681
71838922|NCT03848065|143186301|OTHER||Difference in Percentages|-14.4||||0.153|TWO_SIDED|95.0|-33.2|5.4|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Somnolence (Drowsiness)||5.4|-33.2|0.153
71838923|NCT03848065|143186301|OTHER||Difference in Percentages|10.7||||0.237|TWO_SIDED|95.0|-7.2|28.2|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Irritability||28.2|-7.2|0.237
71838924|NCT03848065|143186301|OTHER||Difference in Percentages|7.4||||0.406|TWO_SIDED|95.0|-10.3|25.0|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Irritability||25.0|-10.3|0.406
71838925|NCT03848065|143186301|OTHER||Difference in Percentages|-3.3||||0.729|TWO_SIDED|95.0|-21.8|15.5|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Irritability||15.5|-21.8|0.729
71838926|NCT03848065|143186301|OTHER||Difference in Percentages|4.6||||0.385|TWO_SIDED|95.0|-7.1|17.5|||Miettinen & Nurminen method||Difference = % V114-SC minus % V114-IM|Urticaria (Hives/Welts)||17.5|-7.1|0.385
71838927|NCT03848065|143186301|OTHER||Difference in Percentages|2.1||||0.719|TWO_SIDED|95.0|-11.0|15.4|||Miettinen & Nurminen method||Difference= % V114-SC minus % PCV13-SC|Urticaria (Hives/Welts)||15.4|-11.0|0.719
71838928|NCT03848065|143186301|OTHER||Difference in Percentages|-2.5||||0.61|TWO_SIDED|95.0|-14.9|8.9|||Miettinen & Nurminen method||Difference= % V114-IM minus % PCV13-SC|Urticaria (Hives/Welts)||8.9|-14.9|0.610
71838929|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-8.1|
71838930|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||8.5|-7.9|
71838931|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 1||7.9|-8.1|
71838932|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114- SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||8.5|-8.1|
71838933|NCT03848065|143186303|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||6.3|-11.7|
71838934|NCT03848065|143186303|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 3||11.6|-6.0|
71838935|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-8.1|
71838936|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||8.5|-7.9|
71672792|NCT02712554|142863783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
71672793|NCT02712554|142863783|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
71672794|NCT02712554|142863784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<.0001
71838937|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 4||7.9|-8.1|
71838938|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-8.1|
71838939|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||8.5|-7.9|
71838940|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 5||7.9|-8.1|
71838941|NCT03848065|143186303|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||6.3|-11.9|
71672795|NCT02712554|142863784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<.0001
71672796|NCT02712554|142863784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1839|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1839
71793291|NCT00362115|143085279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1||||0.0495|TWO_SIDED|95.0|-8.19|-0.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.01|-8.19|0.0495
71793292|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4||||0.0007|TWO_SIDED|95.0|-14.74|-3.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.97|-14.74|0.0007
71793293|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.4|||<|0.0001|TWO_SIDED|95.0|-19.02|-7.73||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.73|-19.02|< 0.0001
71838942|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||8.5|-7.9|
71838943|NCT03848065|143186303|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6A||5.8|-11.9|
71838944|NCT03848065|143186303|OTHER||Difference in Percentages|-9.1|||||TWO_SIDED|95.0|-21.2|-0.2|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||-0.2|-21.2|
71838945|NCT03848065|143186303|OTHER||Difference in Percentages|-6.7|||||TWO_SIDED|95.0|-17.9|2.1|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||2.1|-17.9|
71838946|NCT03848065|143186303|OTHER||Difference in Percentages|-2.4|||||TWO_SIDED|95.0|-15.6|10.2|||||Difference=% V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 6B||10.2|-15.6|
71838947|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||8.5|-8.1|
71838948|NCT03848065|143186303|OTHER||Difference in Percentages|-2.2|||||TWO_SIDED|95.0|-11.7|6.3|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||6.3|-11.7|
71838949|NCT03848065|143186303|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-6.0|11.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 7F||11.6|-6.0|
71838950|NCT03848065|143186303|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-8.1|
71838951|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||8.5|-7.9|
71838952|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 9V||7.9|-8.1|
71838953|NCT03848065|143186303|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|6.3|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||6.3|-11.9|
71838954|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||8.5|-7.9|
71838955|NCT03848065|143186303|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 14||5.8|-11.9|
71838956|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-8.1|
71838957|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||8.5|-7.9|
71838958|NCT03848065|143186303|OTHER||Differences in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 18C||7.9|-8.1|
71838959|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-8.1|
71838960|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||8.5|-7.9|
71838961|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19A||7.9|-8.1|
71672797|NCT02712554|142863784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1751|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1751
71672798|NCT02712554|142863784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<.0001
71793294|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4||||0.0003|TWO_SIDED|95.0|-16.0|-4.83||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.83|-16.00|0.0003
71838962|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-8.1|
71838963|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||8.5|-7.9|
71838964|NCT03848065|143186303|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 19F||7.9|-8.1|
71838965|NCT03848065|143186303|OTHER||Difference in Percentages|0.1|||||TWO_SIDED|95.0|-9.8|10.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||10.4|-9.8|
71838966|NCT03848065|143186303|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||12.4|-5.7|
71793295|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.3|||<|0.0001|TWO_SIDED|95.0|-23.11|-11.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.47|-23.11|< 0.0001
71793296|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-18.01|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-18.01|< 0.0001
71793297|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.2594|TWO_SIDED|95.0|-2.17|8.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||8.01|-2.17|0.2594
71793298|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.6859|TWO_SIDED|95.0|-6.46|4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.26|-6.46|0.6859
71793299|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.4898|TWO_SIDED|95.0|-3.43|7.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.15|-3.43|0.4898
71793300|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.076|TWO_SIDED|95.0|-10.55|0.53||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.53|-10.55|0.0760
71793301|NCT00362115|143085280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9647|TWO_SIDED|95.0|-5.44|5.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.21|-5.44|0.9647
71793302|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.13|-3.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.43|-11.13|0.0002
71838967|NCT03848065|143186303|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-11.9|5.8|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 23F||5.8|-11.9|
71838968|NCT03848065|143186303|OTHER||Difference in Percentages|90.7|||||TWO_SIDED|95.0|77.2|96.4|||||Difference=% V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||96.4|77.2|
71672799|NCT02712554|142863784|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<.0001
71672800|NCT02712554|142863785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<.0001
71793303|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-15.01|-6.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.97|-15.01|< 0.0001
71793304|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.59|-4.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.64|-12.59|< 0.0001
71838969|NCT03848065|143186303|OTHER||Difference in Percentages|95.2|||||TWO_SIDED|95.0|84.1|98.7|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||98.7|84.1|
71838970|NCT03848065|143186303|OTHER||Difference in Percentages|-4.5|||||TWO_SIDED|95.0|-15.2|3.6|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 22F||3.6|-15.2|
71672801|NCT02712554|142863785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<.0001
71793305|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|||<|0.0001|TWO_SIDED|95.0|-17.79|-9.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.50|-17.79|< 0.0001
71793306|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.69|-4.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.70|-12.69|< 0.0001
71793307|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.279|TWO_SIDED|95.0|-1.63|5.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||5.62|-1.63|0.2790
71793308|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3772|TWO_SIDED|95.0|-5.53|2.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-5.53|0.3772
71793309|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.7302|TWO_SIDED|95.0|-3.11|4.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.43|-3.11|0.7302
71793310|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0302|TWO_SIDED|95.0|-8.31|-0.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.42|-8.31|0.0302
71793311|NCT00362115|143085281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.7644|TWO_SIDED|95.0|-3.22|4.38||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.38|-3.22|0.7644
71793312|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.4||||0.0001|TWO_SIDED|95.0|-12.7|-4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.19|-12.70|0.0001
71838971|NCT03848065|143186303|OTHER||Difference in Percentages|81.8|||||TWO_SIDED|95.0|67.9|90.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||90.5|67.9|
71838972|NCT03848065|143186303|OTHER||Difference in Percentages|88.9|||||TWO_SIDED|95.0|76.4|95.2|||||Difference=% V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||95.2|76.4|
71672802|NCT02712554|142863785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.4013
71672803|NCT02712554|142863785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0736|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0736
71672804|NCT02712554|142863785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<.0001
71672805|NCT02712554|142863785|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<.0001
71672806|NCT02712554|142863786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.001
71672807|NCT02712554|142863786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.001
71672808|NCT02712554|142863786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2223|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2223
71672809|NCT02712554|142863786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1638|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1638
71793313|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.19|-9.24||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.24|-18.19|< 0.0001
71793314|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.0001|TWO_SIDED|95.0|-16.66|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.80|-16.66|< 0.0001
71793315|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-22.51|-13.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-13.35|-22.51|< 0.0001
71793316|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.21|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-18.21|< 0.0001
71838973|NCT03848065|143186303|OTHER||Difference in Percentages|-7.1|||||TWO_SIDED|95.0|-22.7|8.2|||||Difference=% V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|ST 33F||8.2|-22.7|
71793317|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.6905|TWO_SIDED|95.0|-3.26|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.91|-3.26|0.6905
71793318|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.0433|TWO_SIDED|95.0|-8.76|-0.13||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.13|-8.76|0.0433
71838974|NCT03848065|143186304|OTHER||Geometric Mean Concentration (GMC) Ratio|0.76|||||TWO_SIDED|95.0|0.58|1.0|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an analysis of variance (ANOVA) model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 1||1.00|0.58|
71838975|NCT03848065|143186304|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.13|0.65|
71838976|NCT03848065|143186304|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.68|1.16|||||GMC Ratio=GMC V114-SC/GMC V114-IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|||1.16|0.68|
71838977|NCT03848065|143186304|OTHER||GMC Ratio|1.3|||||TWO_SIDED|95.0|0.96|1.76|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.76|0.96|
71838978|NCT03848065|143186304|OTHER||GMC Ratio|1.49|||||TWO_SIDED|95.0|1.1|2.01|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||2.01|1.10|
71838979|NCT03848065|143186304|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.65|1.18|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 3||1.18|0.65|
71838980|NCT03848065|143186304|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||0.90|0.58|
71838981|NCT03848065|143186304|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.65|1.0|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.00|0.65|
71838982|NCT03848065|143186304|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.72|1.11|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 4||1.11|0.72|
71838983|NCT03848065|143186304|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.16|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.16|0.60|
71838984|NCT03848065|143186304|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.69|1.31|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.31|0.69|
71838985|NCT03848065|143186304|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 5||1.21|0.64|
71838986|NCT03848065|143186304|OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.47|0.84|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.84|0.47|
71672810|NCT02712554|142863786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||0.0041
71672811|NCT02712554|142863786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.001
71793319|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1736|TWO_SIDED|95.0|-7.22|1.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.31|-7.22|0.1736
71793320|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7||||0.0001|TWO_SIDED|95.0|-13.08|-4.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.23|-13.08|0.0001
71793321|NCT00362115|143085282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.0429|TWO_SIDED|95.0|-8.77|-0.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANOVA|||||-0.14|-8.77|0.0429
71793322|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0009|TWO_SIDED|95.0|-7.77|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-7.77|0.0009
71793323|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|||<|0.0001|TWO_SIDED|95.0|-11.33|-5.32||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.32|-11.33|< 0.0001
71793324|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-11.63|-5.67||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.67|-11.63|< 0.0001
71793325|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-14.34|-8.18||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.18|-14.34|< 0.0001
71793326|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||<|0.0001|TWO_SIDED|95.0|-12.37|-6.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-12.37|< 0.0001
71793327|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.2068|TWO_SIDED|95.0|-0.98|4.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.50|-0.98|0.2068
71793328|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.2622|TWO_SIDED|95.0|-4.56|1.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.25|-4.56|0.2622
71838987|NCT03848065|143186304|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.52|0.93|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||0.93|0.52|
71838988|NCT03848065|143186304|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.68|1.21|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6A||1.21|0.68|
71838989|NCT03848065|143186304|OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.36|0.79|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.79|0.36|
71838990|NCT03848065|143186304|OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||0.90|0.41|
71838991|NCT03848065|143186304|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.59|1.3|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 6B||1.30|0.59|
71838992|NCT03848065|143186304|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.81|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.81|0.46|
71838993|NCT03848065|143186304|OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||0.90|0.52|
71838994|NCT03848065|143186304|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.67|1.17|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 7F||1.17|0.67|
71838995|NCT03848065|143186304|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||0.99|0.57|
71838996|NCT03848065|143186304|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.13|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.13|0.65|
71838997|NCT03848065|143186304|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.67|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 9V||1.15|0.67|
71838998|NCT03848065|143186304|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.6|1.19|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.19|0.60|
71838999|NCT03848065|143186304|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.72|1.43|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.43|0.72|
71839000|NCT03848065|143186304|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.59|1.16|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 14||1.16|0.59|
71839001|NCT03848065|143186304|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.53|0.9|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.90|0.53|
71672812|NCT02712554|142863787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0001
71793329|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.173|TWO_SIDED|95.0|-4.85|0.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.88|-4.85|0.1730
71793330|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0025|TWO_SIDED|95.0|-7.56|-1.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.62|-7.56|0.0025
71793331|NCT00362115|143085283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.0681|TWO_SIDED|95.0|-5.6|0.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.20|-5.60|0.0681
71793332|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6||||0.0004|TWO_SIDED|95.0|-13.28|-3.87||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.87|-13.28|0.0004
71793333|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|||<|0.0001|TWO_SIDED|95.0|-17.26|-7.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.42|-17.26|< 0.0001
71793334|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.51|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.78|-16.51|< 0.0001
71793335|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.0001|TWO_SIDED|95.0|-19.38|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.25|-19.38|< 0.0001
71793336|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.53|-7.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.70|-17.53|< 0.0001
71793337|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.1479|TWO_SIDED|95.0|-1.17|7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||7.72|-1.17|0.1479
71793338|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8382|TWO_SIDED|95.0|-5.16|4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.19|-5.16|0.8382
71793339|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9317|TWO_SIDED|95.0|-4.42|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.82|-4.42|0.9317
71793340|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.3169|TWO_SIDED|95.0|-7.29|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.37|-7.29|0.3169
71793341|NCT00362115|143085284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7488|TWO_SIDED|95.0|-5.44|3.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.91|-5.44|0.7488
71793342|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.0001|TWO_SIDED|95.0|-9.98|-3.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.40|-9.98|< 0.0001
71839002|NCT03848065|143186304|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.54|0.92|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||0.92|0.54|
71839003|NCT03848065|143186304|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.76|1.27|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 18C||1.27|0.76|
71839004|NCT03848065|143186304|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.66|1.15|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.15|0.66|
71839005|NCT03848065|143186304|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.55|0.96|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||0.96|0.55|
71839006|NCT03848065|143186304|OTHER||GMC Ratio|1.19|||||TWO_SIDED|95.0|0.9|1.57|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19A||1.57|0.90|
71839007|NCT03848065|143186304|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.57|0.89|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.89|0.57|
71793343|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-12.76|-5.86||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.86|-12.76|< 0.0001
71793344|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.05|-5.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-12.05|< 0.0001
71793345|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.0001|TWO_SIDED|95.0|-13.92|-6.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.79|-13.92|< 0.0001
71793346|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||<|0.0001|TWO_SIDED|95.0|-13.11|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.20|-13.11|< 0.0001
71839008|NCT03848065|143186304|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.62|0.95|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||0.95|0.62|
71839009|NCT03848065|143186304|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.75|1.15|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 19F||1.15|0.75|
71839010|NCT03848065|143186304|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.57|1.09|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.57|
71839011|NCT03848065|143186304|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.09|0.58|
71839012|NCT03848065|143186304|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.73|1.36|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 23F||1.36|0.73|
71839013|NCT03848065|143186304|OTHER||GMC Ratio|134.88|||||TWO_SIDED|95.0|88.91|204.62|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||204.62|88.91|
71839014|NCT03848065|143186304|OTHER||GMC Ratio|204.6|||||TWO_SIDED|95.0|135.18|309.69|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||309.69|135.18|
71839015|NCT03848065|143186304|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.44|0.99|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 22F||0.99|0.44|
71839016|NCT03848065|143186304|OTHER||GMC Ratio|25.11|||||TWO_SIDED|95.0|15.34|41.13|||||GMC Ratio=GMC V114-SC/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||41.13|15.34|
71839017|NCT03848065|143186304|OTHER||GMC Ratio|34.18|||||TWO_SIDED|95.0|20.93|55.83|||||GMC Ratio=GMC V114-IM/GMC PCV13-SC. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||55.83|20.93|
71839018|NCT03848065|143186304|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.45|1.19|||||GMC Ratio=GMC V114-SC/GMC V114 IM. Based on an ANOVA model with natural log-transformed antibody responses as response variable and vaccination group as a single factor.|ST 33F||1.19|0.45|
71839019|NCT03848065|143186305|OTHER||Difference in Percentages|2.5|||||TWO_SIDED|95.0|-7.7|13.9|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.9|-7.7|
71839020|NCT03848065|143186305|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-10.8|12.0|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||12.0|-10.8|
71839021|NCT03848065|143186305|OTHER||Difference in Percentages|2.2|||||TWO_SIDED|95.0|-8.0|13.0|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Diphtheria Toxin||13.0|-8.0|
71839022|NCT03848065|143186305|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.8|12.4|||||Difference = % V114 SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.8|
71839023|NCT03848065|143186305|OTHER||Difference in Percentages|2.4|||||TWO_SIDED|95.0|-5.7|12.4|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||12.4|-5.7|
71839024|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Tetanus Toxin||7.9|-8.1|
71839025|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-8.1|
71839026|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||8.5|-7.9|
71839027|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114 SC minus % V114 IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis Toxin||7.9|-8.1|
71839028|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-8.1|
71839029|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||8.5|-7.9|
71839030|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Pertussis FHA||7.9|-8.1|
71839031|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-8.1|
71839032|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||8.5|-7.9|
71839033|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 1||7.9|-8.1|
71839034|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-8.1|
71839035|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||Difference = % V114-IM minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||8.5|-7.9|
71839036|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 2||7.9|-8.1|
71839037|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|8.5|||||Difference = % V114-SC minus % PCV13-SC. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||8.5|-8.1|
71672813|NCT02712554|142863787|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
71672814|NCT02712554|142863787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2706|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2706
71672815|NCT02712554|142863787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5507|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.5507
71672816|NCT02712554|142863787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||0.0047
71793347|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.4188|TWO_SIDED|95.0|-1.83|4.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||4.40|-1.83|0.4188
71793348|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4255|TWO_SIDED|95.0|-4.62|1.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.95|-4.62|0.4255
71793349|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.6869|TWO_SIDED|95.0|-3.91|2.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.58|-3.91|0.6869
71793350|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.1678|TWO_SIDED|95.0|-5.77|1.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.01|-5.77|0.1678
71793351|NCT00362115|143085285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3132|TWO_SIDED|95.0|-4.96|1.6||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.60|-4.96|0.3132
71672817|NCT02712554|142863787|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672818|NCT02712554|142863788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo||||0.0001
71672819|NCT02712554|142863788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo||||<0.0001
71672820|NCT02712554|142863788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0014
71793352|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.0||||0.0005|TWO_SIDED|95.0|-12.48|-3.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.52|-12.48|0.0005
71793353|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.24|-5.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.93|-15.24|< 0.0001
71793354|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.1|||<|0.0001|TWO_SIDED|95.0|-14.7|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.44|-14.70|< 0.0001
71839038|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-7.9|8.5|||||"Difference = % V114-IM minus % PCV13~-SC. The 95% CI is based on the Miettinen and Nurminen method."|Poliovirus Type 3||8.5|-7.9|
71839039|NCT03848065|143186305|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-8.1|7.9|||||Difference = % V114-SC minus % V114-IM. The 95% CI is based on the Miettinen and Nurminen method.|Poliovirus Type 3||7.9|-8.1|
71672821|NCT02712554|142863788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0080
71672822|NCT02712554|142863788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71672823|NCT02712554|142863788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672824|NCT02712554|142863789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||0.0024
71839040|NCT04137367|143186306|OTHER|||||||0.05|||||||Mixed Models Analysis|||We estimated a priori that a total of 100 participants would be needed to detect a difference between ABM and sham condition, with a two-tailed α of 0.05 and (1-β) of .80. Power calculation was based on the assumption that 50 % of the participants allocated to ABM would report a minimum of 3 points reduction on BDI-II at six months, compared to 20 % in the sham condition. Assuming 15 % lost to follow up, power calculation indicated the need for 50 participants in each condition||||.05
71672825|NCT02712554|142863789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||0.0012
71672826|NCT02712554|142863789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0037
71672827|NCT02712554|142863789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0011
71672828|NCT02712554|142863789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71672829|NCT02712554|142863789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672830|NCT02712554|142863790|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo||||<0.0001
71672831|NCT02712554|142863790|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo||||<0.0001
71672832|NCT02712554|142863790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0630
71672833|NCT02712554|142863790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4436|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.4436
71672834|NCT02712554|142863790|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71672835|NCT02712554|142863790|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672836|NCT02712554|142863791|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
71672837|NCT02712554|142863791|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
71793355|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||<|0.0001|TWO_SIDED|95.0|-17.95|-8.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.42|-17.95|< 0.0001
71793356|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|||<|0.0001|TWO_SIDED|95.0|-16.74|-7.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-16.74|< 0.0001
71793357|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.8103|TWO_SIDED|95.0|-4.79|3.75||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.75|-4.79|0.8103
71793358|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1702|TWO_SIDED|95.0|-7.57|1.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.34|-7.57|0.1702
71793359|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2504|TWO_SIDED|95.0|-7.02|1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.84|-7.02|0.2504
71793360|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.0144|TWO_SIDED|95.0|-10.28|-1.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.14|-10.28|0.0144
71793361|NCT00362115|143085286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.0402|TWO_SIDED|95.0|-9.06|-0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.21|-9.06|0.0402
71793362|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2||||0.0014|TWO_SIDED|95.0|-8.41|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.41|0.0014
71793363|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||<|0.0001|TWO_SIDED|95.0|-10.82|-4.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.22|-10.82|< 0.0001
71793364|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2|||<|0.0001|TWO_SIDED|95.0|-11.51|-4.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.93|-11.51|< 0.0001
71793365|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1|||<|0.0001|TWO_SIDED|95.0|-12.49|-5.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.72|-12.49|< 0.0001
71892823|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4||||0.0336|TWO_SIDED|95.0|0.7|16.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Social Functioning||16.1|0.7|0.0336
71892824|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.1572|TWO_SIDED|95.0|-1.7|10.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Global Health Status||10.3|-1.7|0.1572
71892825|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.1281|TWO_SIDED|95.0|-10.8|1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Dyspnoea||1.4|-10.8|0.1281
71672838|NCT02712554|142863791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2335|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.2335
71672839|NCT02712554|142863791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.1808
71793366|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|||<|0.0001|TWO_SIDED|95.0|-10.87|-4.3||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.30|-10.87|< 0.0001
71793367|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.5519|TWO_SIDED|95.0|-2.11|3.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.95|-2.11|0.5519
71793368|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3938|TWO_SIDED|95.0|-4.54|1.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.79|-4.54|0.3938
71793369|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1949|TWO_SIDED|95.0|-5.21|1.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.07|-5.21|0.1949
71793370|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0732|TWO_SIDED|95.0|-6.21|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.28|-6.21|0.0732
71793371|NCT00362115|143085287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3669|TWO_SIDED|95.0|-4.59|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.70|-4.59|0.3669
71793372|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2||||0.0019|TWO_SIDED|95.0|-14.94|-3.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-14.94|0.0019
71793373|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0008|TWO_SIDED|95.0|-16.15|-4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.26|-16.15|0.0008
71793374|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.004|TWO_SIDED|95.0|-14.88|-2.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.85|-14.88|0.0040
71672840|NCT02712554|142863791|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71672841|NCT02712554|142863791|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672842|NCT02712554|142863794|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment C (low-dose M366) - Placebo||||<0.0001
71672843|NCT02712554|142863794|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||Treatment D: M366 37.5 mg/1625 mg, Treatment E: Placebo||||<0.0001
71672844|NCT02712554|142863794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1268|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.1268
71672845|NCT02712554|142863794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||0.0014
71793375|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6||||0.0001|TWO_SIDED|95.0|-18.96|-6.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.22|-18.96|0.0001
71793376|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.0004|TWO_SIDED|95.0|-16.85|-4.89||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.89|-16.85|0.0004
71793377|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.3499|TWO_SIDED|95.0|-8.39|2.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.98|-8.39|0.3499
71672846|NCT02712554|142863794|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71793378|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7||||0.2115|TWO_SIDED|95.0|-9.61|2.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.14|-9.61|0.2115
71793379|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.4279|TWO_SIDED|95.0|-8.34|3.54||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.54|-8.34|0.4279
71892826|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.6207|TWO_SIDED|95.0|-8.7|5.2|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Insomnia||5.2|-8.7|0.6207
71672847|NCT02712554|142863794|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672848|NCT02712554|142863795|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment C (low-dose M366) - Placebo||||<0.0001
71672849|NCT02712554|142863795|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment D (high-dose M366) - Placebo||||<0.0001
71672850|NCT02712554|142863795|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)||||0.0120
71672851|NCT02712554|142863795|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)||||<0.0001
71672852|NCT02712554|142863795|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo||||<0.0001
71672853|NCT02712554|142863795|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||TA\_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo||||<0.0001
71672854|NCT01624740|142863796|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||ANOVA|Period effect p=0.11||||||0.74
71672855|NCT02999269|142863797|SUPERIORITY|||||||0.04||||||p-value for time by amplitude interaction|Regression, Linear|||For the primary outcomes (change in HDRS24), we performed a full longitudinal model with an unstructured repeated measures covariance matrix on subjects who completed the study in the assigned treatment arm. The dependent variable was HDRS at each visit and the independent variables included progress (time within the ECT series: pre-, mid-, and post-ECT), amplitude, age, sex, pulse width and the following interactions: progress/amplitude, progress/sex, and progress/pulse width.|Time-by-amplitude interaction (F4, 72 = 2.65, p = 0.04).|||0.04
71672856|NCT02999269|142863797|SUPERIORITY|||||||0.0001|||||||Regression, Linear|||||||0.0001
71672857|NCT02999269|142863798|SUPERIORITY|||||||0.37|||||||Regression, Linear|||||||0.37
71672858|NCT02999269|142863798|SUPERIORITY|||||||0.5||||||p-value is time-by-amplitude interaction|Regression, Linear|||||||0.50
71672859|NCT02999269|142863798|SUPERIORITY||||||<|0.01||||||Progress (F2,71 = 11.15, p \< 0.01)|Regression, Linear|||||||< 0.01
71672860|NCT01102257|142863817|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71672861|NCT01894841|142863838|SUPERIORITY||Partial eta squared|0.03||||0.13|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.13
71672862|NCT01894841|142863839|SUPERIORITY||Partial eta squared|0.01||||0.79|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.79
71672863|NCT01894841|142863840|SUPERIORITY||Partial eta squared|0.02||||0.49|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.49
71672864|NCT01894841|142863841|SUPERIORITY||Partial eta-squared|0.003||||0.96|TWO_SIDED|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA|||||||.96
71793380|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0566|TWO_SIDED|95.0|-12.41|0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.17|-12.41|0.0566
71793381|NCT00362115|143085288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.1435|TWO_SIDED|95.0|-10.3|1.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.50|-10.30|0.1435
71793382|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.1162|TWO_SIDED|95.0|-6.16|0.68||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.68|-6.16|0.1162
71793383|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.2494|TWO_SIDED|95.0|-5.69|1.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.48|-5.69|0.2494
71793384|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.4247|TWO_SIDED|95.0|-5.01|2.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.12|-5.01|0.4247
71793385|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.3007|TWO_SIDED|95.0|-5.79|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.80|-5.79|0.3007
71793386|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.1195|TWO_SIDED|95.0|-6.67|0.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.77|-6.67|0.1195
71793387|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2032|TWO_SIDED|95.0|-5.76|1.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.23|-5.76|0.2032
71793388|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3787|TWO_SIDED|95.0|-5.27|2.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.01|-5.27|0.3787
71793389|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.5967|TWO_SIDED|95.0|-4.59|2.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.64|-4.59|0.5967
71793390|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.4345|TWO_SIDED|95.0|-5.36|2.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.31|-5.36|0.4345
71793391|NCT00362115|143085289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.1954|TWO_SIDED|95.0|-6.24|1.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.28|-6.24|0.1954
71793392|NCT01344161|143085290|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.001|TWO_SIDED|95.0|||||ANCOVA|An analysis of covariance (ANCOVA) was used to adjust mean differences on all variables.||||||0.001
71793393|NCT00697515|143085296|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71793394|NCT00697515|143085297|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||ANOVA|||2.0 hours post-dose||||0.0017
71793395|NCT00697515|143085297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
71793396|NCT00697515|143085297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
71793397|NCT00697515|143085297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
71793398|NCT00697515|143085297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
71793399|NCT00697515|143085297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
71793400|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Average over the treatment day||||<0.0001
71793401|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANOVA|||2.0 hours post-dose||||0.0010
71793402|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
71793403|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
71793404|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
71793405|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
71793406|NCT00697515|143085298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
71793407|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||Over the treatment day||||<0.0001
71793408|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||ANOVA|||2.0 hours post-dose||||0.0031
71793409|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||4.0 hours post-dose||||<0.0001
71793410|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||8.0 hours post-dose||||<0.0001
71793411|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||10.0 hours post-dose||||<0.0001
71793412|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||12.0 hours post-dose||||<0.0001
71793413|NCT00697515|143085299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||14.0 hours post-dose||||<0.0001
71793414|NCT00697515|143085300|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71793415|NCT00697515|143085301|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<0.0001
71793416|NCT00697515|143085304|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Prescott's Test|||||||<0.0001
71793417|NCT00697515|143085305|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71793418|NCT00697515|143085307|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71793419|NCT00697515|143085308|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71793420|NCT02310919|143085313|NON_INFERIORITY|For the non-inferiority hypothesis testing of the primary outcome, a one-sided 95% CI was constructed for the relative risk. The alternative trigger will be considered non-inferior to the standard trigger if the lower bound of the one-sided CI of the relative risk is not less than 0.8 (i.e. risk reduction limit of 20%).|Risk Ratio (RR)|0.91|||||ONE_SIDED|95.0|0.83|||Using the standard trigger as the reference, the relative risk (i.e. risk ratio) (RR) with 95% confidence interval (CI) for the probability of the outcome was calculated using log-binomial regression models with application of GEE.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The alternative trigger will be considered non-inferior to the standard hCG trigger if it is at least 80% as effective at inducing oocyte competence. Considering a cluster size of 15 oocytes and an estimated intra-cluster correlation of 0.1, we calculated that approximately 50 participants were needed in each study arm when the non-inferiority difference is -0.1 (i.e. 20% of 0.5 total competent proportion) with a power of 0.8 and a one-sided alpha of 0.05.|||0.83|
71793421|NCT02310919|143085314|SUPERIORITY||Risk Ratio (RR)|0.85||||0.06|TWO_SIDED|95.0|0.71|1.01||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in number of oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.01|0.71|0.06
71793422|NCT02310919|143085315|SUPERIORITY||Risk Ratio (RR)|0.87||||0.13|TWO_SIDED|95.0|0.72|1.04||The statistical significance was based on a two-sided alpha of 0.05.|generalized linear model with log link|Comparison was done using generalized linear modeling with log link function.|The numerator was the outcome with the alternative trigger, and the denominator was the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the number of MII oocytes retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.04|0.72|0.13
71793423|NCT02310919|143085316|SUPERIORITY||Risk Ratio (RR)|0.97||||0.47|TWO_SIDED|95.0|0.9|1.05||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in oocyte maturity rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.05|0.90|0.47
71793424|NCT02310919|143085317|SUPERIORITY||Risk Ratio (RR)|0.88||||0.01|TWO_SIDED|95.0|0.76|0.97||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||0.97|0.76|0.01
71793425|NCT02310919|143085318|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.9|1.1||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in ICSI fertilization rate retrieved between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.10|0.90|0.95
71793426|NCT02310919|143085319|SUPERIORITY||Risk Ratio (RR)|0.95||||0.52|TWO_SIDED|95.0|0.81|1.12||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in the percentage of high quality cleavage-stage embryos between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.12|0.81|0.52
71793427|NCT02310919|143085320|SUPERIORITY||Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.84|1.16||The statistical significance was based on a two-sided alpha of 0.05.|log-binomial regression with GEE||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|||1.16|0.84|0.87
71793428|NCT02310919|143085321|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.59|1.74||The statistical significance was based on a two-sided alpha of 0.05.|Fisher Exact||The numerator was the probability of the outcome with the alternative trigger, and the denominator was the probability of the outcome with the standard trigger.|The null hypothesis was that there would be no difference in livebirths in fresh transfers between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||1.74|0.59|1.0
71793429|NCT02310919|143085322|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in bloating scores from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.98
71793430|NCT02310919|143085323|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in abdominal circumference from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.39
71793431|NCT02310919|143085324|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that there would be no difference in the change in body weight from day of baseline ultrasound to post-trigger day 5 between the patients triggered with low dose hCG plus FSH co-trigger and the standard hCG trigger.||||0.41
71793432|NCT02310919|143085325|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793433|NCT02310919|143085326|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793434|NCT02310919|143085327|SUPERIORITY|||||||0.08||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.08
71793435|NCT02310919|143085328|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793436|NCT02310919|143085329|SUPERIORITY|||||||0.67||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.67
71793437|NCT02310919|143085330|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71892827|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.7||||0.0193|TWO_SIDED|95.0|-16.0|-1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Appetite Loss||-1.4|-16.0|0.0193
71892828|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.6249|TWO_SIDED|95.0|-4.4|7.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Constipation||7.3|-4.4|0.6249
71793438|NCT02310919|143085331|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793439|NCT02310919|143085332|SUPERIORITY|||||||0.49||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.49
71793440|NCT02310919|143085333|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71839041|NCT05329220|143186414|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.89||||0.635|TWO_SIDED|97.5|0.5|1.57||P-value corresponds to Cohort 1 ABNCoV2 comparison to Cohort 1 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||1.57|0.50|0.6350
71839042|NCT05329220|143186414|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.8||||0.0002|TWO_SIDED|97.5|0.7|0.92||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.92|0.70|0.0002
71839043|NCT05329220|143186415|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.76||||0.0008|TWO_SIDED|97.5|0.64|0.91||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron variant BA.4/BA.5|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.91|0.64|0.0008
71892829|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.1534|TWO_SIDED|95.0|-7.2|1.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Diarrhoea||1.1|-7.2|0.1534
71892830|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.4915|TWO_SIDED|95.0|-9.7|4.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Financial Difficulties||4.7|-9.7|0.4915
71793441|NCT02310919|143085334|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793442|NCT02310919|143085335|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793443|NCT02310919|143085336|SUPERIORITY|||||||0.16||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.16
71793444|NCT02310919|143085337|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793445|NCT02310919|143085338|SUPERIORITY||||||<|0.001||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71793446|NCT02310919|143085339|SUPERIORITY|||||||0.95||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.95
71793447|NCT02310919|143085340|SUPERIORITY|||||||0.07||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.07
71793448|NCT02310919|143085341|SUPERIORITY|||||||0.66||||||The statistical significance was based on a two-sided alpha of 0.05.|Wilcoxon (Mann-Whitney)|||||||0.66
71793449|NCT01549964|143085432|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.77|-0.34||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.34|-0.77|<0.001
71793450|NCT01549964|143085432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.15|0.49||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.49|0.15|<0.001
71793451|NCT01549964|143085432|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.109|<|0.001|TWO_SIDED|95.0|-1.03|-0.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-0.60|-1.03|<0.001
71793452|NCT01549964|143085432|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.524|TWO_SIDED|95.0|-0.12|0.23||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||0.23|-0.12|0.524
71892831|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4||||0.1789|TWO_SIDED|95.0|-10.8|2.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Fatigue||2.0|-10.8|0.1789
71793453|NCT01549964|143085433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.05|TWO_SIDED|95.0|1.0|5.08||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||5.08|1.00|0.050
71793454|NCT01549964|143085433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||<|0.001|TWO_SIDED|95.0|0.23|0.67||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||0.67|0.23|<0.001
71793455|NCT01549964|143085433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.06|||<|0.001|TWO_SIDED|95.0|2.24|11.42||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||11.42|2.24|<0.001
71793456|NCT01549964|143085433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.493|TWO_SIDED|95.0|0.5|1.39||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic|||||1.39|0.50|0.493
71793457|NCT01549964|143085434|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.2|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-33.8|-16.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-16.6|-33.8|<0.001
71793458|NCT01549964|143085434|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|3.49||0.142|TWO_SIDED|95.0|-12.0|1.7||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||1.7|-12.0|0.142
71793459|NCT01549964|143085434|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-39.9|-22.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-22.6|-39.9|<0.001
71793460|NCT01549964|143085434|SUPERIORITY_OR_OTHER||Least Square Mean difference|-11.2|STANDARD_ERROR_OF_MEAN|3.53||0.002|TWO_SIDED|95.0|-18.1|-4.2||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements|||||-4.2|-18.1|0.002
71793461|NCT02438722|143085436|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.44|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||||1.36|0.50|0.44
71793462|NCT02438722|143085437|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.72|1.43|||Log Rank|||||1.43|0.72|0.94
71793463|NCT02438722|143085439|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.54|TWO_SIDED|95.0|0.64|1.26|||Log Rank|||||1.26|0.64|0.54
71839044|NCT05329220|143186415|NON_INFERIORITY|The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.|Geometric Mean Ratio|0.69|||<|0.0001|TWO_SIDED|97.5|0.59|0.81||P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron Variant XBB.1.5.|Mixed Models Analysis|A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.||Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is \>=0.67.||0.81|0.59|<0.0001
71892832|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.4578|TWO_SIDED|95.0|-6.0|2.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Nausea and Vomiting||2.7|-6.0|0.4578
71793464|NCT02438722|143085440|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.95|TWO_SIDED|95.0|0.73|1.39|||Log Rank|||||1.39|0.73|0.95
71793465|NCT00909779|143085448|NON_INFERIORITY_OR_EQUIVALENCE|"The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).~The non-inferiority margin for the hazard ratio is 1.4."|Hazard Ratio (HR)|0.606|||||TWO_SIDED|95.0|0.425|0.864|||Regression, Cox||Hazard ratio was calculated as arformoterol vs. placebo.|"The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).~The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated."||0.864|0.425|
71793466|NCT01520363|143085469|SUPERIORITY||Mean Difference (Net)|-1.182|STANDARD_DEVIATION|4.294||0.211|TWO_SIDED|95.0|-3.086|0.722|||t-test, 2 sided|df=21|||t= -1.291; p=.211|.722|-3.086|.211
71793467|NCT01520363|143085469|SUPERIORITY||Median Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.67||0.949|TWO_SIDED|95.0|-1.345|1.432|||t-test, 2 sided|df=22||||1.432|-1.345|.949
71793468|NCT01520363|143085470|SUPERIORITY||Mean Difference (Final Values)|0.333|STANDARD_DEVIATION|2.456||0.541|TWO_SIDED|95.0|-0.785|1.451||df=20|t-test, 2 sided|df=20|||t=0.622; p=.541|1.451|-0.785|.541
71793469|NCT01520363|143085470|SUPERIORITY||Mean Difference (Net)|-0.042|STANDARD_DEVIATION|2.956||0.946|TWO_SIDED|95.0|-1.29|1.206||df=23|t-test, 2 sided||||t=-.069; p=0.946|1.206|-1.290|.946
71793470|NCT01520363|143085471|SUPERIORITY||Mean Difference (Net)|-0.227|STANDARD_DEVIATION|3.116||0.736|TWO_SIDED|95.0|-1.609|1.154|||t-test, 2 sided|df=21|||t=-0.342; p=0.736|1.154|-1.609|.736
71793471|NCT01520363|143085471|SUPERIORITY||Mean Difference (Net)|0.409|STANDARD_DEVIATION|3.5||0.589|TWO_SIDED|95.0|-1.143|1.961|||t-test, 2 sided||||t=0.548; p=0.589|1.961|-1.143|.589
71793472|NCT01520363|143085472|SUPERIORITY||Mean Difference (Net)|-1.429|STANDARD_DEVIATION|3.203||0.05|TWO_SIDED|95.0|-2.886|0.029|||t-test, 2 sided|df=20|||t=-2.044; p=0.05|0.029|-2.886|.05
71793473|NCT01520363|143085472|SUPERIORITY||Mean Difference (Net)|0.042|STANDARD_DEVIATION|3.862||0.958|TWO_SIDED|95.0|-1.589|1.672|||t-test, 2 sided||||t=0.053; p=0.958|1.672|-1.589|0.958
71793474|NCT01520363|143085473|SUPERIORITY||Median Difference (Net)|0.227|STANDARD_DEVIATION|1.51||0.488|TWO_SIDED|95.0|-0.442|0.897|||t-test, 2 sided|df=21|||t=0.706; p=0.488|0.897|-0.442|0.488
71793475|NCT01520363|143085473|SUPERIORITY||Median Difference (Net)|0.24|STANDARD_DEVIATION|1.535||0.442|TWO_SIDED|95.0|-0.394|0.874|||t-test, 2 sided|df=24|||t=0.782; p=0.442|0.874|-0.394|0.442
71793476|NCT01520363|143085474|SUPERIORITY||Mean Difference (Net)|0.682|STANDARD_DEVIATION|2.317||0.182|TWO_SIDED|95.0|-0.346|1.709|||t-test, 2 sided|df=21|||t=1.380; p=0.182|1.709|-0.346|0.182
71839045|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.998|TWO_SIDED|95.0|-17.81|17.86|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||17.86|-17.81|0.998
71839046|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.445|TWO_SIDED|95.0|-24.73|10.93||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||10.93|-24.73|0.445
71839047|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|2.51||||0.781|TWO_SIDED|95.0|-15.33|20.36||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||20.36|-15.33|0.781
71839048|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.732|TWO_SIDED|95.0|-20.93|14.75||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||14.75|-20.93|0.732
71839049|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.212|TWO_SIDED|95.0|-6.53|29.14||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 15 minutes post injection||29.14|-6.53|0.212
71839050|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-6.44||||0.476|TWO_SIDED|95.0|-24.27|11.39|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||11.39|-24.27|0.476
71839051|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.962|TWO_SIDED|95.0|-17.4|18.26|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 15 minutes post injection||18.26|-17.40|0.962
71839052|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.211|TWO_SIDED|95.0|-6.96|31.16|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||31.16|-6.96|0.211
71839053|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|2.67||||0.782|TWO_SIDED|95.0|-16.4|21.73|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||21.73|-16.40|0.782
71892833|NCT01564784|143306960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.8428|TWO_SIDED|95.0|-7.3|6.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Pain||6.0|-7.3|0.8428
71839054|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.129|TWO_SIDED|95.0|-4.34|33.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.78|-4.34|0.129
71839055|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|13.27||||0.171|TWO_SIDED|95.0|-5.8|32.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||32.35|-5.80|0.171
71839056|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|15.56||||0.108|TWO_SIDED|95.0|-3.49|34.62|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||34.62|-3.49|0.108
71839057|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|4.24||||0.661|TWO_SIDED|95.0|-14.83|23.3|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||23.30|-14.83|0.661
71839058|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|14.21||||0.142|TWO_SIDED|95.0|-4.85|33.27|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 30 minutes post injection||33.27|-4.85|0.142
71839059|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|11.98||||0.216|TWO_SIDED|95.0|-7.08|31.04|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.04|-7.08|0.216
71839060|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|7.38||||0.445|TWO_SIDED|95.0|-11.71|26.48|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||26.48|-11.71|0.445
71839061|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.096|TWO_SIDED|95.0|-2.92|35.19|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||35.19|-2.92|0.096
71839062|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|11.89||||0.22|TWO_SIDED|95.0|-7.19|30.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||30.96|-7.19|0.220
71839063|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|12.71||||0.189|TWO_SIDED|95.0|-6.35|31.78|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||31.78|-6.35|0.189
71892834|NCT01564784|143306961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.171|TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||0.07|-0.01|0.1710
71892835|NCT01564784|143306962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6||||0.1172|TWO_SIDED|95.0|-1.2|10.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||||10.4|-1.2|0.1172
71672865|NCT01894841|142863842|SUPERIORITY||Partial eta squared|0.01||||0.62|TWO_SIDED||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).||||||.62
71793477|NCT01520363|143085474|SUPERIORITY||Mean Difference (Net)|1.16|STANDARD_DEVIATION|1.864|<|0.005|TWO_SIDED|95.0|0.391|1.929|||t-test, 2 sided|df=24|||t=3.112; p=0.005|1.929|0.391|<0.005
71793478|NCT01520363|143085475|SUPERIORITY||Mean Difference (Net)|0.091|STANDARD_DEVIATION|3.504||0.9|TWO_SIDED|95.0|-1.463|1.644|||t-test, 2 sided||||t=0.122; p=0.90|1.644|-1.463|0.90
71793479|NCT01520363|143085475|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|2.551||0.356|TWO_SIDED|95.0|-0.573|1.533|||t-test, 2 sided|df=24|||t=0.941; p=0.356|1.533|-0.573|0.356
71793480|NCT01520363|143085476|SUPERIORITY||Mean Difference (Net)|0.136|STANDARD_DEVIATION|3.06||0.836|TWO_SIDED|95.0|-1.22|1.493|||t-test, 2 sided||||t=0.209; p=0.836|1.493|-1.220|0.836
71793481|NCT01520363|143085476|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_DEVIATION|2.698||0.826|TWO_SIDED|95.0|-0.993|1.233|||t-test, 2 sided|df=24|||t=0.222; p=0.826|1.233|-0.993|0.826
71793482|NCT01520363|143085477|SUPERIORITY||Mean Difference (Net)|-3.38|STANDARD_ERROR_OF_MEAN|4.18||0.42|TWO_SIDED|95.0|-11.8|5.05|||t-test, 2 sided|||||5.05|-11.80|0.42
71793483|NCT01520363|143085478|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|2.97|<|0.73|TWO_SIDED|95.0|-7.02|4.96|||t-test, 2 sided|||||4.96|-7.02|<0.73
71793484|NCT01520363|143085479|SUPERIORITY||Mean Difference (Net)|8.4615|STANDARD_DEVIATION|32.8016||0.371|TWO_SIDED|95.0|-11.3603|28.2834|||t-test, 2 sided|df=12|||t=0.903; p=0.371|28.2834|-11.3603|0.371
71793485|NCT01520363|143085479|SUPERIORITY||Mean Difference (Net)|4.9917|STANDARD_DEVIATION|18.0163||0.358|TWO_SIDED|95.0|-6.4553|16.4387|||t-test, 2 sided|df=11|t=0.960; p=0.358|||16.4387|-6.4553|0.358
71793486|NCT01520363|143085480|SUPERIORITY||Mean Difference (Net)|3.09412|STANDARD_DEVIATION|24.06228||0.603|TWO_SIDED|95.0|-9.27756|15.4658|||t-test, 2 sided|df=16|t=0.530; p=0.603|||15.46580|-9.27756|0.603
71793487|NCT01520363|143085480|SUPERIORITY||Mean Difference (Net)|2.42857|STANDARD_DEVIATION|11.21479||0.432|TWO_SIDED|95.0|-4.04665|8.9038|||t-test, 2 sided|df=13|t=0.810; p=0.432|||8.90380|-4.04665|0.432
71793488|NCT01520363|143085481|SUPERIORITY||Mean Difference (Net)|11.765|STANDARD_DEVIATION|26.276||0.083|TWO_SIDED|95.0|-1.745|25.275|||t-test, 2 sided|df=16|||t=1.846; p=0.083|25.275|-1.745|0.083
71793489|NCT01520363|143085481|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_DEVIATION|14.378||0.073|TWO_SIDED|95.0|-0.802|15.802|||t-test, 2 sided|df=13|||t=1.952; p=0.073|15.802|-0.802|0.073
71793490|NCT01520363|143085482|SUPERIORITY||Mean Difference (Net)|3.7474|STANDARD_DEVIATION|26.711||0.549|TWO_SIDED|95.0|-9.1269|16.6217|||t-test, 2 sided|df=18|t=0.612; p=0.549|||16.6217|-9.1269|0.549
71793491|NCT01520363|143085482|SUPERIORITY||Mean Difference (Net)|0.7143|STANDARD_DEVIATION|16.5084||0.874|TWO_SIDED|95.0|-8.8174|10.246|||t-test, 2 sided|df=13|t=0.162; p=0.874|||10.2460|-8.8174|0.874
71793492|NCT01520363|143085483|SUPERIORITY||Mean Difference (Net)|3.8167|STANDARD_DEVIATION|40.2609||0.693|TWO_SIDED|95.0|-16.2046|23.8379|||t-test, 2 sided|df=17|t=0.402; p=0.693|||23.8379|-16.2046|0.693
71793493|NCT01520363|143085483|SUPERIORITY||Mean Difference (Net)|0.84|STANDARD_DEVIATION|27.8994||0.909|TWO_SIDED|95.0|-14.6102|16.2902|||t-test, 2 sided|df=14|t=0.117; p=0.909|||16.2902|-14.6102|0.909
71793494|NCT01520363|143085484|SUPERIORITY||Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.64||0.21|TWO_SIDED|95.0|-2.17|0.52|||t-test, 2 sided|||||0.52|-2.17|0.21
71672866|NCT00529087|142863860|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|24.4|||<|0.001||95.0|17.3|31.4|||Chi-squared|||||31.4|17.3|<0.001
71672867|NCT00529087|142863861|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.5|||<|0.001||95.0|15.1|24.0|||t-test, 2 sided|||||24.0|15.1|<0.001
71793495|NCT01520363|143085485|SUPERIORITY||Mean Difference (Net)|0.74|STANDARD_ERROR_OF_MEAN|0.68||0.28|TWO_SIDED|95.0|-0.66|2.15|||t-test, 2 sided|||||2.15|-0.66|0.28
71793496|NCT01272830|143085488|SUPERIORITY|||||||0.0063||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data.||||0.0063
71793497|NCT01272830|143085488|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Changes from baseline data||||>0.05
71793498|NCT01272830|143085489|SUPERIORITY|||||||0.0226||||||Significance threshold p\<0.5|paired|||Change from baseline data (HSS pain walking)||||0.0226
71793499|NCT01272830|143085489|SUPERIORITY|||||||0.0375||||||Significance threshold P\<0.05|paired t-test|||Change from baseline data (HSS total score)||||0.0375
71793500|NCT01272830|143085489|SUPERIORITY|||||||0.0391||||||Significance threshold p\<0.05|paired t-test|||Change from baseline data (KSS knee pain)||||0.0391
71793501|NCT01272830|143085489|SUPERIORITY|||||||0.2137|||||||paired t-test|||Changes from baseline data (HSS pain walking)||||0.2137
71793502|NCT01272830|143085489|SUPERIORITY|||||||0.1312|||||||paired t-test|||Change from baseline data (HSS total score)||||0.1312
71793503|NCT01272830|143085489|SUPERIORITY|||||||0.1578|||||||paired t-test|||Change from baseline data (KSS knee pain)||||0.1578
71793504|NCT01272830|143085490|SUPERIORITY|||||||0.0083||||||Significance threshold p\<0.05|t-test|||Changes from baseline data||||0.0083
71793505|NCT01272830|143085490|SUPERIORITY||||||>|0.05||||||Significant threshold p\<0.05|paired t-test|||Change from baseline data||||>0.05
71793506|NCT01272830|143085491|SUPERIORITY|||||||0.01||||||Significance threshold p\<0.05|ANOVA|||Change from baseline data||||0.01
71793507|NCT01272830|143085491|SUPERIORITY||||||>|0.05|||||||paired t-test|Significant threshold p\<0.05||Changes from baseline data||||>0.05
71793508|NCT00579826|143085506|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71793509|NCT00579826|143085507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71793510|NCT00579826|143085508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71793511|NCT00579826|143085509|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71793512|NCT00579826|143085510|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71793513|NCT01748643|143085511|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71793514|NCT01748643|143085512|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71793515|NCT01748643|143085513|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71793516|NCT01748643|143085514|SUPERIORITY|||||||0.97|||||||t-test, 1 sided|||||||0.97
71793517|NCT01748643|143085515|SUPERIORITY|||||||0.64|||||||t-test, 1 sided|||||||0.64
71793518|NCT01748643|143085516|SUPERIORITY|||||||0.58|||||||t-test, 1 sided|||||||0.58
71892836|NCT00045032|143306988|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71839064|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-2.67||||0.782|TWO_SIDED|95.0|-21.75|16.41|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||16.41|-21.75|0.782
71839065|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.528|TWO_SIDED|95.0|-12.98|25.18|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 60 minutes post injection||25.18|-12.98|0.528
71839066|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|2.34||||0.795|TWO_SIDED|95.0|-15.45|20.12|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||20.12|-15.45|0.795
71839067|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-6.13||||0.497|TWO_SIDED|95.0|-23.96|11.69|||mean difference|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||11.69|-23.96|0.497
71672868|NCT00529087|142863861|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.9|||<|0.001||95.0|16.1|25.7|||t-test, 2 sided|||||25.7|16.1|<0.001
71672869|NCT00529087|142863862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Log Rank|Log-rank test for comparisons of survival distributions||||||<0.001
71672870|NCT00529087|142863863|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.6|||<|0.001||95.0|1.1|2.1|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||2.1|1.1|<0.001
71672871|NCT00529087|142863863|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.7||||0.011||95.0|0.2|1.2|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate||||1.2|0.2|0.011
71793519|NCT00620828|143085588|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Patient cohort was inclusive of patient undergoing single TKA from June 2007 to July 2008. Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.||||<0.05
71793520|NCT00620828|143085589|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||Significant differences in Fentanyl PCA pump usage across study arms were assessed for the 4-8h,8-12h,and 12h-24h time frames.||||.05
71672872|NCT00529087|142863865|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|20.4|||<|0.001||95.0|9.5|31.3|||Chi-squared|||||31.3|9.5|<0.001
71672873|NCT00529087|142863865|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|7.0||||0.212||95.0|-4.0|18.0|||Chi-squared|||||18.0|-4.0|0.212
71839068|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|7.44||||0.409|TWO_SIDED|95.0|-10.34|25.21|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.21|-10.34|0.409
71839069|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|7.89||||0.382|TWO_SIDED|95.0|-9.92|25.7|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.70|-9.92|0.382
71839070|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|7.74||||0.39|TWO_SIDED|95.0|-10.05|25.54|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||25.54|-10.05|0.390
71839071|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-3.72||||0.68|TWO_SIDED|95.0|-21.54|14.1|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||14.10|-21.54|0.680
71839072|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.927|TWO_SIDED|95.0|-16.99|18.65|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 90 minutes post injection||18.65|-16.99|0.927
71672874|NCT00529087|142863866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
71672875|NCT00529087|142863866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.||||<0.001
71672876|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.5|||<|0.001||95.0|11.2|17.9|||ANOVA|Treatment as a factor||1 hour||17.9|11.2|<0.001
71672877|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.001||95.0|4.6|11.4|||ANOVA|Treatment as a factor||1 hour||11.4|4.6|<0.001
71672878|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.5|||<|0.001||95.0|14.4|22.5|||ANOVA|Treatment as a factor||2 hours||22.5|14.4|<0.001
71672879|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.4|||<|0.001||95.0|6.3|14.5|||ANOVA|Treatment as a factor||2 hours||14.5|6.3|<0.001
71672880|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|||<|0.001||95.0|15.0|23.5|||ANOVA|Treatment as a factor||3 hours||23.5|15.0|<0.001
71672881|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.7|15.3|||ANOVA|Treatment as a factor||3 hours||15.3|6.7|<0.001
71672882|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.5|||<|0.001||95.0|15.2|23.9|||ANOVA|Treatment as a factor||4 hours||23.9|15.2|<0.001
71672883|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.6|15.4|||ANOVA|Treatment as a factor||4 hours||15.4|6.6|<0.001
71793521|NCT00620828|143085590|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||This analysis was performed on data collected 24-hours post-operatively for patient cohort.||||.05
71793522|NCT00620828|143085591|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 1 sided|||Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort.||||.05
71892837|NCT00045032|143306988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.67|0.44|
71892838|NCT00045032|143306989|SUPERIORITY_OR_OTHER|||||||0|||||||Log Rank|||||||0.000
71672884|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.7|||<|0.001||95.0|15.2|24.1|||ANOVA|Treatment as a factor||6 hours||24.1|15.2|<0.001
71672885|NCT00529087|142863867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||<|0.001||95.0|6.2|15.2|||ANOVA|Treatment as a factor||6 hours||15.2|6.2|<0.001
71672886|NCT00529087|142863868|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|21.0|||<|0.001||95.0|10.2|31.9|||Chi-squared|||||31.9|10.2|<0.001
71793523|NCT00620828|143085592|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Straight leg raise data collected at 4-hours, 8-hours, 12-hours and 24-hours post-operatively for patient cohort.||||.05
71793524|NCT01154218|143085597|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.56|||||TWO_SIDED|90.0|91.49|108.33||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.33|91.49|
71793525|NCT01154218|143085597|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|106.93|||||TWO_SIDED|90.0|98.26|116.35||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||116.35|98.26|
71793526|NCT01154218|143085597|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|85.76|||||TWO_SIDED|90.0|78.88|93.25||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.25|78.88|
71793527|NCT01154218|143085598|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|99.6|||||TWO_SIDED|90.0|91.3|108.66||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.66|91.30|
71793528|NCT01154218|143085598|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|107.56|||||TWO_SIDED|90.0|98.58|117.35||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||117.35|98.58|
71793529|NCT01154218|143085598|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|85.52|||||TWO_SIDED|90.0|78.45|93.22||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||93.22|78.45|
71793530|NCT01154218|143085601|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|106.97|||||TWO_SIDED|90.0|96.55|118.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.51|96.55|
71793531|NCT01154218|143085601|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.32|||||TWO_SIDED|90.0|100.47|123.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||123.33|100.47|
71793532|NCT01154218|143085601|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|86.22|||||TWO_SIDED|90.0|77.89|95.43||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||95.43|77.89|
71892839|NCT00045032|143306989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.34|0.53|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.53|0.34|
71892840|NCT00045032|143306992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892841|NCT00045032|143306992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.67|
71892842|NCT00045032|143306992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892843|NCT00045032|143306992|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.67|
71672887|NCT00529087|142863868|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.316||95.0|-5.3|16.5|||Chi-squared|||||16.5|-5.3|0.316
71672888|NCT00529087|142863869|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.7|||<|0.001||95.0|9.4|30.1|||Chi-squared|||||30.1|9.4|<0.001
71672889|NCT00529087|142863869|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|13.3||||0.016||95.0|2.6|24.0|||Chi-squared|||||24.0|2.6|0.016
71672890|NCT00529087|142863870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||<|0.001||95.0|1.0|1.9|||ANCOVA|Treatment as factor, Baseline as covariate||||1.9|1.0|<0.001
71672891|NCT00529087|142863870|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.102||95.0|-0.1|0.8|||ANCOVA|Treatment as factor, Baseline as covariate||||0.8|-0.1|0.102
71672892|NCT00529087|142863871|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|||<|0.001||95.0|0.6|1.5|||ANCOVA|||||1.5|0.6|<0.001
71672893|NCT00529087|142863871|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|||<|0.001||95.0|0.0|0.9|||ANCOVA|||||0.9|0.0|<0.001
71672894|NCT00529087|142863872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|||<|0.001||95.0|0.8|1.6|||ANCOVA|Treatment as factor, Baseline as covariate||||1.6|0.8|<0.001
71672895|NCT00529087|142863872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.012||95.0|0.1|0.9|||ANCOVA|Treatment as factor, Baseline as covariate||||0.9|0.1|0.012
71793533|NCT01154218|143085604|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.03|||||TWO_SIDED|90.0|90.16|110.97||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.97|90.16|
71793534|NCT01154218|143085604|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.85|||||TWO_SIDED|90.0|98.11|120.77||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.77|98.11|
71793535|NCT01154218|143085604|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|74.87|||||TWO_SIDED|90.0|67.55|82.98||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||82.98|67.55|
71793536|NCT01154218|143085605|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|100.08|||||TWO_SIDED|90.0|90.46|110.73||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.73|90.46|
71793537|NCT01154218|143085605|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.47|||||TWO_SIDED|90.0|98.03|120.02||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||120.02|98.03|
71793538|NCT01154218|143085605|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|76.59|||||TWO_SIDED|90.0|69.23|84.74||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||84.74|69.23|
71793539|NCT01154218|143085606|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|102.11|||||TWO_SIDED|90.0|92.84|112.31||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.31|92.84|
71793540|NCT01154218|143085606|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|108.87|||||TWO_SIDED|90.0|98.98|119.75||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.75|98.98|
71793541|NCT01154218|143085606|SUPERIORITY_OR_OTHER||Ratio of Adjusted means|71.94|||||TWO_SIDED|90.0|65.46|79.05||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||79.05|65.46|
71793542|NCT03965962|143085609|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 2) was greater than (\>) -5% at Day 28.|Difference in Percentage|-0.42|||||TWO_SIDED|95.0|-2.33|4.35||||||||4.35|-2.33|
71793543|NCT03965962|143085609|NON_INFERIORITY|The two-sided 95 % CI was calculated based on the Wilson score method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control group (Group 3) was \> -5% at Day 28.|Difference in Percentage|0.86|||||TWO_SIDED|95.0|-1.32|6.5||||||||6.50|-1.32|
71839073|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|6.02||||0.508|TWO_SIDED|95.0|-11.95|23.98||The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.|Mixed Model Repeated Measures.|||Outcome Measure at 120 minutes post injection||23.98|-11.95|0.508
71672896|NCT00529087|142863873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.002||95.0|0.2|0.7|||ANCOVA|Treatment as factor, Baseline as covariate||||0.7|0.2|0.002
71672897|NCT00529087|142863873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.119||95.0|-0.1|0.5|||ANCOVA|Treatment as factor, Baseline as covariate||||0.5|-0.1|0.119
71672898|NCT00529087|142863874|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3||||0.008||95.0|-0.5|-0.1|||ANCOVA|Treatment as factor, Baseline as covariate||||-0.1|-0.5|0.008
71672899|NCT00529087|142863874|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.2||||0.015||95.0|-0.5|0.0|||ANCOVA|Treatment as factor, Baseline as covariate||||0.0|-0.5|0.015
71672900|NCT00529087|142863877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.731||95.0|-5.4|7.7|||ANCOVA|Treatment as factor, Baseline as covariate||||7.7|-5.4|0.731
71672901|NCT00529087|142863877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.779||95.0|-5.6|7.5|||ANCOVA|Treatment as factor, Baseline as covariate||||7.5|-5.6|0.779
71672902|NCT00529087|142863878|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|5.6||||0.023||95.0|0.8|10.4|||ANCOVA|Treatment as factor, baseline as covariate||||10.4|0.8|0.023
71672903|NCT00529087|142863878|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.8||||0.258||95.0|-2.0|7.6|||ANCOVA|Treatment as factor, baseline as covariate||||7.6|-2.0|0.258
71672904|NCT00529087|142863880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.0||||0.071||95.0|-0.6|14.5|||ANCOVA|Treatment as factor, baseline as covariate||||14.5|-0.6|0.071
71672905|NCT00529087|142863880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.087||95.0|-1.0|14.2|||ANCOVA|Treatment as factor, baseline as covariate||||14.2|-1.0|0.087
71672906|NCT00529087|142863881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6||||0.038||95.0|0.4|14.7|||ANCOVA|Treatment as factor, baseline as covariate||||14.7|0.4|0.038
71672907|NCT00529087|142863881|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.237||95.0|-2.8|11.5|||ANCOVA|Treatment as factor, baseline as covariate||||11.5|-2.8|0.237
71672908|NCT00457002|142863905|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.4364|TWO_SIDED|95.0|0.62|1.23|||Mantel Haenszel|||To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.||1.23|0.62|0.4364
71672909|NCT00457002|142863905|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39|||||TWO_SIDED|95.0|-1.37|0.59||||||||0.59|-1.37|
71672910|NCT00457002|142863906|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.69|1.63||||||Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.||1.63|0.69|
71672911|NCT00457002|142863906|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.61|0.81||||||||0.81|-0.61|
71793544|NCT00729183|143085620|SUPERIORITY_OR_OTHER||Difference in LS Means|3.49|||<|0.001|TWO_SIDED|95.0|2.66|4.32|||Longitudinal Data Analysis (LDA) Model|||A longitudinal ANCOVA was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% confidence interval (CI). The model, applied on all time points during treatment (Screening Visit \[BL\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted Least Squares (LS) mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||4.32|2.66|<0.001
71793545|NCT00729183|143085621|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.2|||||TWO_SIDED|95.0|-12.3|7.9||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||7.9|-12.3|
71793546|NCT00729183|143085622|SUPERIORITY_OR_OTHER||Difference in Percentage|4.4|||||TWO_SIDED|95.0|-3.2|12.3||||||Estimated difference (versus Placebo) and CI were based on the Miettinen \& Nurminen method.||12.3|-3.2|
71793547|NCT00729183|143085623|SUPERIORITY_OR_OTHER||Difference in LS Means|5.39|||<|0.001|TWO_SIDED|95.0|4.36|6.42|||LDA|||A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted LS mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.||6.42|4.36|<0.001
71793548|NCT00729183|143085624|SUPERIORITY_OR_OTHER||Difference in LS Means|1.57|||<|0.001|TWO_SIDED|95.0|0.88|2.25|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.25|0.88|<0.001
71892844|NCT00045032|143306997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.68|
71672912|NCT00457002|142863907|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.7|1.71||||||||1.71|0.70|
71672913|NCT00457002|142863907|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.14|||||TWO_SIDED|95.0|-0.57|0.85||||||||0.85|-0.57|
71672914|NCT00457002|142863908|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.78|1.2||||||||1.20|0.78|
71672915|NCT00457002|142863908|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-1.65|1.17||||||||1.17|-1.65|
71672916|NCT00457002|142863909|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.79|1.22||||||||1.22|0.79|
71672917|NCT00457002|142863909|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.12|||||TWO_SIDED|95.0|-1.52|1.29||||||||1.29|-1.52|
71672918|NCT00457002|142863910|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||||1.29|0.65|
71672919|NCT00457002|142863910|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.26|||||TWO_SIDED|95.0|-1.23|0.71||||||||0.71|-1.23|
71672920|NCT00457002|142863911|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.11|4.05||||||||4.05|0.11|
71672921|NCT00457002|142863911|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.16|0.1||||||||0.10|-0.16|
71672922|NCT00457002|142863912|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.68|1.16||||||||1.16|0.68|
71672923|NCT00457002|142863912|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-1.25|0.48||||||||0.48|-1.25|
71672924|NCT00457002|142863913|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
71672925|NCT00457002|142863913|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-0.78|-0.03||||||||-0.03|-0.78|
71672926|NCT00457002|142863914|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.84|1.28||||||||1.28|0.84|
71672927|NCT00457002|142863914|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-1.18|1.73||||||||1.73|-1.18|
71672928|NCT00457002|142863915|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
71672929|NCT00457002|142863915|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
71672930|NCT00457002|142863916|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.32|2.43||||||||2.43|0.32|
71672931|NCT00457002|142863916|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.26|0.2||||||||0.20|-0.26|
71672932|NCT00457002|142863917|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||||TWO_SIDED|95.0|0.11|0.83||||||||0.83|0.11|
71672933|NCT00457002|142863917|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.34|||||TWO_SIDED|95.0|-0.62|-0.07||||||||-0.07|-0.62|
71672934|NCT00457002|142863918|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.65|1.37||||||||1.37|0.65|
71672935|NCT00457002|142863918|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-1.04|0.76||||||||0.76|-1.04|
71793549|NCT00729183|143085624|SUPERIORITY_OR_OTHER||Difference in LS Means|3.32|||<|0.001|TWO_SIDED|95.0|2.39|4.26|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.26|2.39|<0.001
71793550|NCT00729183|143085625|SUPERIORITY_OR_OTHER||Difference in LS Means|1.48||||0.001|TWO_SIDED|95.0|0.6|2.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.35|0.60|0.001
71672936|NCT00457002|142863919|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.29|-0.02||||||Note: Relative risk was not estimable (0.0); only risk difference could be estimated.||-0.02|-0.29|
71793551|NCT00729183|143085625|SUPERIORITY_OR_OTHER||Difference in LS Means|3.81|||<|0.001|TWO_SIDED|95.0|2.69|4.93|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||4.93|2.69|<0.001
71793552|NCT00729183|143085626|SUPERIORITY_OR_OTHER||Difference in LS Means|2.19|||<|0.001|TWO_SIDED|95.0|1.09|3.29|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||3.29|1.09|<0.001
71793553|NCT00729183|143085626|SUPERIORITY_OR_OTHER||Difference in LS Means|5.48|||<|0.001|TWO_SIDED|95.0|4.08|6.89|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||6.89|4.08|<0.001
71793554|NCT00729183|143085627|SUPERIORITY_OR_OTHER||Difference in LS Means|0.71||||0.03|TWO_SIDED|95.0|0.07|1.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||1.35|0.07|0.030
71793555|NCT00729183|143085627|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7|||<|0.001|TWO_SIDED|95.0|0.97|2.43|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.43|0.97|<0.001
71793556|NCT00729183|143085628|SUPERIORITY_OR_OTHER||Difference in LS Means|1.71||||0.001|TWO_SIDED|95.0|0.69|2.73|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||2.73|0.69|0.001
71793557|NCT00729183|143085628|SUPERIORITY_OR_OTHER||Difference in LS Means|2.7|||<|0.001|TWO_SIDED|95.0|1.62|3.78|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||3.78|1.62|<0.001
71793558|NCT00729183|143085629|SUPERIORITY_OR_OTHER||Difference in LS Means|0.16||||0.697|TWO_SIDED|95.0|-0.63|0.95|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||0.95|-0.63|0.697
71892845|NCT00045032|143306997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.69|0.87|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.87|0.69|
71672937|NCT00457002|142863920|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||||TWO_SIDED|95.0|0.14|1.16||||||||1.16|0.14|
71672938|NCT00457002|142863920|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.22|||||TWO_SIDED|95.0|-0.47|0.03||||||||0.03|-0.47|
71677262|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1051||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Painful Eyes||||0.1051
71793559|NCT00729183|143085629|SUPERIORITY_OR_OTHER||Difference in LS Means|1.22||||0.013|TWO_SIDED|95.0|0.27|2.18|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||2.18|0.27|0.013
71839074|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-3.65||||0.688|TWO_SIDED|95.0|-21.66|14.35|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.35|-21.66|0.688
71839075|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|16.08||||0.079|TWO_SIDED|95.0|-1.88|34.03|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||34.03|-1.88|0.079
71839076|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.323|TWO_SIDED|95.0|-8.96|26.96|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||26.96|-8.96|0.323
71839077|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|11.23||||0.183|TWO_SIDED|95.0|-5.39|27.85|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||27.85|-5.39|0.183
71839078|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|-2.61||||0.756|TWO_SIDED|95.0|-19.24|14.02|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||14.02|-19.24|0.756
71839079|NCT04802967|143186527|SUPERIORITY||Mean Difference (Final Values)|3.96||||0.638|TWO_SIDED|95.0|-12.68|20.59|||Mixed Model Repeated Measures.|The p value was determined using MMRM model, based on treatment, timepoint, baseline value as covariable and subject as a random effect.||Outcome Measure at 120 minutes post injection||20.59|-12.68|0.638
71892846|NCT00045032|143307004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.7962|TWO_SIDED|95.0|0.89|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.89|0.7962
71892847|NCT00045032|143307006|SUPERIORITY_OR_OTHER|||||||0.2379|||||||Log Rank|||||||0.2379
71839080|NCT04114877|143186537|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
71839081|NCT04114877|143186538|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
71839082|NCT04114877|143186539|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
71839083|NCT04114877|143186540|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|Linear mixed models||||||>0.05
71839084|NCT04114877|143186541|SUPERIORITY|||||||0.455|||||||Fisher Exact|||||||0.455
71839085|NCT06429319|143186542|SUPERIORITY||F value|5.919||||0.004|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||No sample size calculation was performed. Maximum expected number of participants for OLE was 72 patients randomized to the NOLTREX™ group in the parent study (IA/PAAG-SI/OA/2019). A total of 65 patients entered the OLE. The study did not have a formal hypothesis. The between-group comparison of changes from baseline (OLE visit 0) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.004
71839086|NCT06429319|143186542|SUPERIORITY||LS-means difference|-37.64|STANDARD_ERROR_OF_MEAN|56.34||0.783|TWO_SIDED|95.0|-172.98|97.7||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||97.70|-172.98|0.783
71839087|NCT06429319|143186542|SUPERIORITY||LS-means difference|81.94|STANDARD_ERROR_OF_MEAN|60.45||0.37|TWO_SIDED|95.0|-63.28|227.16|||Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||227.16|-63.28|0.370
71892848|NCT00045032|143307006|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.47|1.21|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||1.21|0.47|
71892849|NCT00045032|143307007|SUPERIORITY_OR_OTHER|||||||0.003|||||||Log Rank|||||||0.003
71892850|NCT00045032|143307007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.28|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.28|
71892851|NCT00045032|143307010|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
71892852|NCT00045032|143307010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.88|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.88|0.65|
71892853|NCT00045032|143307010|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Log Rank|||||||0.0001
71892854|NCT00045032|143307010|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.63|0.86|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.86|0.63|
71892855|NCT00045032|143307012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.64|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.86|0.64|
71793560|NCT00729183|143085630|SUPERIORITY_OR_OTHER||Difference in LS Means|8.01|||<|0.001|TWO_SIDED|95.0|6.03|9.99|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||9.99|6.03|<0.001
71793561|NCT00729183|143085630|SUPERIORITY_OR_OTHER||Difference in LS Means|11.46|||<|0.001|TWO_SIDED|95.0|8.96|13.97|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||13.97|8.96|<0.001
71793562|NCT00729183|143085631|SUPERIORITY_OR_OTHER||Difference in LS Means|5.68|||<|0.001|TWO_SIDED|95.0|3.77|7.58|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||7.58|3.77|<0.001
71793563|NCT00729183|143085631|SUPERIORITY_OR_OTHER||Difference in LS Means|9.38|||<|0.001|TWO_SIDED|95.0|6.98|11.77|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit \[Baseline\], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo||11.77|6.98|<0.001
71793564|NCT00729183|143085632|SUPERIORITY_OR_OTHER||Difference in LS Means|-54.03|||<|0.001|TWO_SIDED|95.0|-64.81|-43.26|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-43.26|-64.81|<0.001
71793565|NCT00729183|143085632|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.59|||<|0.001|TWO_SIDED|95.0|-62.22|-28.96|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo||-28.96|-62.22|<0.001
71793566|NCT00729183|143085633|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.34|||<|0.001|TWO_SIDED|95.0|-37.77|-12.92|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo.||-12.92|-37.77|<0.001
71793567|NCT00729183|143085633|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.07||||0.225|TWO_SIDED|95.0|-23.69|5.56|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline \[Randomization\], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo.||5.56|-23.69|0.225
71793568|NCT05497284|143085636|OTHER|Probability (LTP001 is better than placebo)|Slope|-2.6|STANDARD_DEVIATION|2.07|||TWO_SIDED|80.0|-6.9|1.3||Probability that LTP001 is better than placebo is 10.3%|Baysesian random slope model|Bayesian random slope model to assess the difference in reduction rate (slope) in years between the treatment group and placebo group.||||1.3|-6.9|
71672939|NCT00457002|142863921|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.29||||0.0437|TWO_SIDED|95.0|0.01|0.57||The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.|Mantel Haenszel|||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||0.57|0.01|0.0437
71839088|NCT06429319|143186542|SUPERIORITY||LS-means difference|119.58|STANDARD_ERROR_OF_MEAN|34.76||0.003|TWO_SIDED|95.0|36.09|203.07||Difference between Least-square means was tested at a level of p \<0.05 via Tukey's multiple comparison test.|Tukey's HSD|||Post-hoc pairwise comparisons were performed using Tukey test.||203.07|36.09|0.003
71839089|NCT06429319|143186542|SUPERIORITY||F value|2.78||||0.07|TWO_SIDED|||||The threshold for statistical significance was p \<0.05.|ANCOVA|"To compare the efficacy of one and two NOLTREX™ courses was used ANCOVA adjusted for the baseline value with fixed factor of treatment group."||The between-group comparison of changes from baseline (visit 1 study 1) in the WOMAC-T at visit 5 was conducted using analysis of covariance (ANCOVA) and, as a post hoc test, the Tukey test.||||0.070
71839090|NCT06429319|143186546|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (study 1 visit 1)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.030
71892856|NCT00045032|143307012|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.83|0.62|
71892857|NCT00045032|143307014|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9156|TWO_SIDED|95.0|0.84|1.21|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.21|0.84|0.9156
71672940|NCT00457002|142863922|SUPERIORITY_OR_OTHER||Adjusted Difference of event rates|0.36|||||TWO_SIDED|95.0|-0.33|1.06||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.06|-0.33|
71793569|NCT03878446|143085646|SUPERIORITY||Treatment difference|-1.4|||||TWO_SIDED|95.0|-3.2|0.4||||||||0.4|-3.2|
71793570|NCT03878446|143085646|SUPERIORITY||Treatment difference|0.7|||||TWO_SIDED|95.0|-1.1|2.5||||||||2.5|-1.1|
71793571|NCT03878446|143085646|SUPERIORITY||Treatment difference|-0.9|||||TWO_SIDED|95.0|-2.6|0.9||||||||0.9|-2.6|
71672941|NCT00457002|142863923|SUPERIORITY_OR_OTHER||Adjustted difference of event rates|0.59|||||TWO_SIDED|95.0|-16.0|1.33||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).||1.33|-016|
71672942|NCT00457002|142863924|SUPERIORITY_OR_OTHER||Adjusted Difference of Event Rates|0.87|||||TWO_SIDED|95.0|-0.4|2.14||||||||2.14|-0.40|
71672943|NCT00457002|142863925|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.74|1.61||||||||1.61|0.74|
71793572|NCT03878446|143085646|SUPERIORITY||Treatment difference|-0.6|||||TWO_SIDED|95.0|-2.4|1.2||||||||1.2|-2.4|
71793573|NCT04865354|143085696|NON_INFERIORITY|Noninferiority to be concluded if least squares means difference upper confidence limit is less than 0.05.|Least Squares Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0034|||ONE_SIDED|95.0||0.009||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.||LSM results based on general linear mixed effects model with terms for lens, period and sequence as fixed effects, subject as a random effect|Difference = PRECISION1 minus Clariti 1-Day|||0.009||
71793574|NCT01925404|143085697|SUPERIORITY|We fitted difference-in-differences (DID) models between the two measurement waves and four study arms. The effect of the intervention was modeled as the wave by study arm interaction. All models used random effects to account for intra-class correlation within each park as well as fixed effects to account for observation times (time of day, weekend versus weekdays).||||||0.0063||||||Significance threshold. p=0.05|negative binomial distribution|||Comparison of change from baseline;||||.0063
71672944|NCT00457002|142863925|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||||TWO_SIDED|95.0|-0.66|1.07||||||||1.07|-0.66|
71672945|NCT00457002|142863934|SUPERIORITY_OR_OTHER||Adjusted Event rate difference|0.0|||||TWO_SIDED|95.0|-0.3|0.29|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference in event rates in MI or stroke.||0.29|-0.30|
71672946|NCT00457002|142863934|SUPERIORITY_OR_OTHER||Adjusted difference of event rates|0.09|||||TWO_SIDED|95.0|-0.11|0.3|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates for myocardial infarction.||0.30|-0.11|
71672947|NCT00457002|142863934|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|-0.1|||||TWO_SIDED|95.0|-0.32|0.12||||||Adjusted difference in event rates for stroke.||0.12|-0.32|
71672948|NCT00457002|142863934|SUPERIORITY_OR_OTHER||Adjusted difference in event rates|0.09|||||TWO_SIDED|95.0|-0.09|0.28|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates in thrombocytopenia.||0.28|-0.09|
71672949|NCT00708552|142863986|SUPERIORITY||Mean Difference (Net)|1.1||||0.159|TWO_SIDED|95.0|-0.4|2.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 24||2.7|-0.4|0.159
71793575|NCT00706641|143085701|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||paired t-test|||Tumor samples from 20 patients were analyzed for expression of pSFK. A paired t-Test was used to calculate the significance of the difference in expression levels before and after treatment.||||0.003
71793576|NCT00706641|143085704|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||paired t-test|||||||0.20
71793577|NCT00706641|143085705|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||paired t-test|||||||0.42
71793578|NCT00004888|143085707|SUPERIORITY_OR_OTHER||Overall Response Rate|0.474|||||TWO_SIDED|95.0|0.31|0.642||||||||0.642|0.31|
71793579|NCT00004888|143085707|SUPERIORITY_OR_OTHER||Overall Response Rate|0.457|||||TWO_SIDED|95.0|0.309|0.61||||||||0.61|0.309|
71793580|NCT02174848|143085730|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone.||||0.0500
71793581|NCT02174848|143085730|SUPERIORITY|||||||0.9781|||||||t-test, 2 sided|||This comparison is for the extension study, during which patients in both groups received deferiprone.||||0.9781
71793582|NCT02174848|143085731|SUPERIORITY|||||||0.0206|||||||paired t-test|||||||0.0206
71793583|NCT02174848|143085732|SUPERIORITY|||||||0.2684|||||||paired t-test|||||||0.2684
71793584|NCT02174848|143085733|SUPERIORITY|||||||0.0821|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone||||0.0821
71793585|NCT02174848|143085733|SUPERIORITY|||||||0.5885|||||||t-test, 2 sided|||For the placebo-DFP group, the comparison is of the scores at the start vs. the end of the extension study; for the DFP-DFP group, the comparison is of the scores at the start vs. the end of the initial study||||0.5885
71793586|NCT02174848|143085734|SUPERIORITY|||||||0.3306|||||||t-test, 2 sided|||||||0.3306
71793587|NCT00644969|143085754|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.74||||0.0457|TWO_SIDED|95.0|1.03|21.78|||Regression, Logistic|||||21.78|1.03|0.0457
71793588|NCT00644969|143085755|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18||||0.0901|TWO_SIDED|95.0|0.75|50.71|||Regression, Logistic|||||50.71|0.75|0.0901
71793589|NCT00644969|143085756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.1524|TWO_SIDED|95.0|0.82|3.68|||Regression, Logistic|||Week 12||3.68|0.82|0.1524
71793590|NCT00644969|143085756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9235|TWO_SIDED|95.0|0.45|2.05|||Regression, Logistic|||Week 24||2.05|0.45|0.9235
71793591|NCT00644969|143085757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.0077|TWO_SIDED|95.0|-6.32|-0.99|||ANCOVA||Least squares mean difference|Week 12 treatment difference||-0.99|-6.32|0.0077
71672950|NCT00708552|142863986|SUPERIORITY||Mean Difference (Net)|0.7||||0.41|TWO_SIDED|95.0|-0.9|2.3|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 24||2.3|-0.9|0.410
71793592|NCT00644969|143085757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.9022|TWO_SIDED|95.0|-3.99|3.52|||ANCOVA||Least squares mean difference|Week 24 treatment difference||3.52|-3.99|0.9022
71793593|NCT02515942|143085760|SUPERIORITY|Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|Treatment Effect|-0.35||||0.0636|TWO_SIDED|80.0|-0.64|-0.06|||ANCOVA|||||-0.06|-0.64|0.0636
71793594|NCT02515942|143085760|SUPERIORITY||Treatment Effect|-0.29||||0.1019|TWO_SIDED|80.0|-0.59|0.0|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.00|-0.59|0.1019
71793595|NCT02515942|143085760|SUPERIORITY||Treatment Effect|0.06||||0.5987|TWO_SIDED|80.0|-0.24|0.35|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.||0.35|-0.24|0.5987
71793596|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.5029|TWO_SIDED|80.0|-0.11|0.11|||Mixed Models Analysis|||Change from baseline at Day 85||0.11|-0.11|0.5029
71793597|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.682|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6820
71793598|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.6826|TWO_SIDED|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85||0.14|-0.07|0.6826
71793599|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.12||||0.1545|TWO_SIDED|80.0|-0.28|0.03|||Mixed Models Analysis|||Change from baseline at Day 169||0.03|-0.28|0.1545
71793600|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.13||||0.1398|TWO_SIDED|80.0|-0.29|0.02|||Mixed Models Analysis|||Change from baseline at Day 169||0.02|-0.29|0.1398
71793601|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.01||||0.4717|TWO_SIDED|80.0|-0.16|0.14|||Mixed Models Analysis|||Change from baseline at Day 169||0.14|-0.16|0.4717
71793602|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.25||||0.053|TWO_SIDED|80.0|-0.45|-0.05|||Mixed Models Analysis|||Change from baseline at Day 253||-0.05|-0.45|0.0530
71839091|NCT06429319|143186546|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"BASELINE (OLE visit 0)~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.002
71839092|NCT06429319|143186546|SUPERIORITY|||||||0.007||||||The threshold for statistical significance was p \<0.05.|ANOVA|||"visit 3~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||0.007
71892858|NCT00045032|143307016|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71672951|NCT00708552|142863986|SUPERIORITY||Mean Difference (Net)|-0.2||||0.821|TWO_SIDED|95.0|-1.6|1.2|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepezil at Week 24||1.2|-1.6|0.821
71793603|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.17||||0.1386|TWO_SIDED|80.0|-0.37|0.03|||Mixed Models Analysis|||Change from baseline at Day 253||0.03|-0.37|0.1386
71793604|NCT02515942|143085761|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.08||||0.7087|TWO_SIDED|80.0|-0.11|0.27|||Mixed Models Analysis|||Change from baseline at Day 253||0.27|-0.11|0.7087
71892859|NCT00045032|143307016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
71839093|NCT06429319|143186546|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||"visit 5~To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution."||||<0.001
71839094|NCT06429319|143186547|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"Fisher's exact test was used to determine whether there is a significant difference between 3 groups.~visit 3"||||<0.001
71672952|NCT00708552|142863987|SUPERIORITY||Mean Difference (Net)|0.2||||0.254|TWO_SIDED|95.0|-0.1|0.5|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.1|0.254
71672953|NCT00708552|142863987|SUPERIORITY||Mean Difference (Net)|-0.1||||0.394|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.4|0.394
71672954|NCT00708552|142863987|SUPERIORITY||Mean Difference (Net)|-0.3||||0.049|TWO_SIDED|95.0|-0.6|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepezil at Week 24||-0.0|-0.6|0.049
71672955|NCT00708552|142863988|SUPERIORITY||Mean Difference (Net)|-1.6||||0.423|TWO_SIDED|95.0|-5.6|2.3|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-15mg at Week 24||2.3|-5.6|0.423
71672956|NCT00708552|142863988|SUPERIORITY||Mean Difference (Net)|-2.1||||0.305|TWO_SIDED|95.0|-6.1|1.9|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-35mg at Week 24||1.9|-6.1|0.305
71793605|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.72||||0.9243|TWO_SIDED|80.0|-5.15|-0.29|||Mixed Models Analysis|||Change from baseline at Day 2||-0.29|-5.15|0.9243
71793606|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.51||||0.3929|TWO_SIDED|80.0|-1.89|2.91|||Mixed Models Analysis|||Change from baseline at Day 2||2.91|-1.89|0.3929
71793607|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.23||||0.0418|TWO_SIDED|80.0|0.85|5.61|||Mixed Models Analysis|||Change from baseline at Day 2||5.61|0.85|0.0418
71793608|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.32||||0.5632|TWO_SIDED|80.0|-2.91|2.27|||Mixed Models Analysis|||Change from baseline at Day 8||2.27|-2.91|0.5632
71793609|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2575|TWO_SIDED|80.0|-1.25|3.83|||Mixed Models Analysis|||Change from baseline at Day 8||3.83|-1.25|0.2575
71793610|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.61||||0.2058|TWO_SIDED|80.0|-0.91|4.12|||Mixed Models Analysis|||Change from baseline at Day 8||4.12|-0.91|0.2058
71793611|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8392|TWO_SIDED|80.0|-4.44|0.57|||Mixed Models Analysis|||Change from baseline at Day 15||0.57|-4.44|0.8392
71793612|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effecgt|-0.12||||0.5255|TWO_SIDED|80.0|-2.59|2.35|||Mixed Models Analysis|||Change from baseline at Day 15||2.35|-2.59|0.5255
71839095|NCT06429319|143186547|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there is a significant difference between 3 groups."||||<0.001
71672957|NCT00708552|142863988|SUPERIORITY||Mean Difference (Net)|2.0||||0.282|TWO_SIDED|95.0|-1.7|5.7|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs Donepezil at Week 24||5.7|-1.7|0.282
71839096|NCT06429319|143186548|SUPERIORITY|||||||0.018||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 3~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||0.018
71839097|NCT06429319|143186548|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p \<0.05.|Fisher Exact|||"visit 5~Fisher's exact test was used to determine whether there was a significant difference between 3 groups."||||<0.001
71839098|NCT06429319|143186551|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p \<0.05.|Kruskal-Wallis|||To determine a statistically significant difference between 3 groups the one-way ANOVA (for normally distributed data; aov) or the Kruskal-Wallis test (for non-normally distributed data; kw) was used. The Shapiro-Wilk test was employed to assess the normality of the data distribution.||||0.010
71892860|NCT00045032|143307016|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892861|NCT00045032|143307016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
71793613|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.81||||0.1685|TWO_SIDED|80.0|-0.61|4.24|||Mixed Models Analysis|||Change from baseline at Day 15||4.24|-0.61|0.1685
71793614|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment|-2.01||||0.8544|TWO_SIDED|80.0|-4.45|0.43|||Mixed Models Analysis|||Change from baseline at Day 29||0.43|-4.45|0.8544
71793615|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.03||||0.1402|TWO_SIDED|80.0|-0.38|4.44|||Mixed Models Analysis|||Change from baseline at Day 29||4.44|-0.38|0.1402
71793616|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.03||||0.015|TWO_SIDED|80.0|1.67|6.4|||Mixed Models Analysis|||Change from baseline at Day 29||6.40|1.67|0.0150
71793617|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.14||||0.4682|TWO_SIDED|80.0|-2.11|2.39|||Mixed Models Analysis|||Change from baseline at Day 30||2.39|-2.11|0.4682
71793618|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.38||||0.4125|TWO_SIDED|80.0|-1.84|2.6|||Mixed Models Analysis|||Change from baseline at Day 30||2.60|-1.84|0.4125
71793619|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.24||||0.4431|TWO_SIDED|80.0|-1.94|2.42|||Mixed Models Analysis|||Change from baseline at Day 30||2.42|-1.94|0.4431
71793620|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.04||||0.6924|TWO_SIDED|80.0|-3.72|1.63|||Mixed Models Analysis|||Change from baseline at Day 57||1.63|-3.72|0.6924
71793621|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.61||||0.616|TWO_SIDED|80.0|-3.26|2.04|||Mixed Models Analysis|||Change from baseline at Day 57||2.04|-3.26|0.6160
71839099|NCT00085735|143186555|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.5|||||ONE_SIDED|80.0||1.9||||||The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.||1.9||
71793622|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.44||||0.4149|TWO_SIDED|80.0|-2.18|3.06|||Mixed Models Analysis|||Change from baseline at Day 57||3.06|-2.18|0.4149
71793623|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2582|TWO_SIDED|80.0|-1.27|3.85|||Mixed Models Analysis|||Change from baseline at Day 85||3.85|-1.27|0.2582
71839100|NCT00085735|143186555|NON_INFERIORITY|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.0|||||ONE_SIDED|94.0||1.3||||||The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.||1.3||
71672958|NCT00708552|142863989|SUPERIORITY||Mean Difference (Net)|1.4||||0.096|TWO_SIDED|95.0|-0.3|3.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.1|-0.3|0.096
71672959|NCT00708552|142863989|SUPERIORITY||Mean Difference (Net)|1.0||||0.281|TWO_SIDED|95.0|-0.8|2.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||2.8|-0.8|0.281
71672960|NCT00708552|142863989|SUPERIORITY||Mean Difference (Net)|0.4||||0.63|TWO_SIDED|95.0|-1.1|1.9|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.9|-1.1|0.630
71672961|NCT00708552|142863989|SUPERIORITY||Mean Difference (Net)|-1.1||||0.655|TWO_SIDED|95.0|-5.7|3.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-5.7|0.655
71672962|NCT00708552|142863989|SUPERIORITY||Mean Difference (Net)|-1.5||||0.545|TWO_SIDED|95.0|-6.2|3.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.3|-6.2|0.545
71672963|NCT00708552|142863989|SUPERIORITY||Mean Difference (Net)|2.4||||0.27|TWO_SIDED|95.0|-1.9|6.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 24||6.8|-1.9|0.270
71793624|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.81||||0.3402|TWO_SIDED|80.0|-1.72|3.34|||Mixed Models Analysis|||Change from baseline at Day 85||3.34|-1.72|0.3402
71793625|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.48||||0.5976|TWO_SIDED|80.0|-2.99|2.03|||Mixed Models Analysis|||Change from baseline at Day 85||2.03|-2.99|0.5976
71793626|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.5||||0.5916|TWO_SIDED|80.0|-3.3|2.29|||Mixed Models Analysis|||Change from baseline at Day 113||2.29|-3.30|0.5916
71793627|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5564|TWO_SIDED|80.0|-3.05|2.45|||Mixed Models Analysis|||Change from baseline at Day 113||2.45|-3.05|0.5564
71793628|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.2||||0.4625|TWO_SIDED|80.0|-2.53|2.93|||Mixed Models Analysis|||Change from baseline at Day 113||2.93|-2.53|0.4625
71793629|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8221|TWO_SIDED|80.0|-4.64|0.76|||Mixed Models Analysis|||Change from baseline at Day 141||0.76|-4.64|0.8221
71793630|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.98||||0.3179|TWO_SIDED|80.0|-1.68|3.64|||Mixed Models Analysis|||Change from baseline at Day 141||3.64|-1.68|0.3179
71793631|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.92||||0.0773|TWO_SIDED|80.0|0.29|5.55|||Mixed Models Analysis|||Change from baseline at Day 141||5.55|0.29|0.0773
71793632|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6708|TWO_SIDED|80.0|-3.71|1.81|||Mixed Models Analysis|||Change from baseline at Day 169||1.81|-3.71|0.6708
71839101|NCT01824875|143186575|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.07|||||Hazard ratio of Arm B/Arm A|||1.07|0.46|
71839102|NCT01824875|143186576|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
71839103|NCT02677805|143186601|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71672964|NCT00708552|142863990|SUPERIORITY||Mean Difference (Net)|1.5||||0.138|TWO_SIDED|95.0|-0.5|3.6|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24||3.6|-0.5|0.138
71672965|NCT00708552|142863990|SUPERIORITY||Mean Difference (Net)|1.3||||0.216|TWO_SIDED|95.0|-0.7|3.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24||3.2|-0.7|0.216
71672966|NCT00708552|142863990|SUPERIORITY||Mean Difference (Net)|-0.1||||0.921|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.921
71672967|NCT00708552|142863990|SUPERIORITY||Mean Difference (Net)|-2.1||||0.41|TWO_SIDED|95.0|-7.0|2.9|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24||2.9|-7.0|0.410
71793633|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.99||||0.679|TWO_SIDED|80.0|-3.71|1.74|||Mixed Models Analysis|||Change from baseline at Day 169||1.74|-3.71|0.6790
71793634|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.04||||0.507|TWO_SIDED|80.0|-2.72|2.64|||Mixed Models Analysis|||Change from baseline at Day 169||2.64|-2.72|0.5070
71793635|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5487|TWO_SIDED|80.0|-3.44|2.84|||Mixed Models Analysis|||Change from baseline at Day 197||2.84|-3.44|0.5487
71793636|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.25||||0.6973|TWO_SIDED|80.0|-4.35|1.85|||Mixed Models Analysis|||Change from baseline at Day 197||1.85|-4.35|0.6973
71793637|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6548|TWO_SIDED|80.0|-4.0|2.11|||Mixed Models Analysis|||Change from baseline at Day 197||2.11|-4.00|0.6548
71793638|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.35||||0.5533|TWO_SIDED|80.0|-3.76|3.05|||Mixed Models Analysis|||Change from baseline at Day 225||3.05|-3.76|0.5533
71793639|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3358|TWO_SIDED|80.0|-2.25|4.46|||Mixed Models Analysis|||Change from baseline at Day 225||4.46|-2.25|0.3358
71839104|NCT02677805|143186602|SUPERIORITY|||||||0.087||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary Outcome Measure shows a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.087
71839105|NCT02677805|143186603|SUPERIORITY|||||||0.121||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||||||0.121
71793640|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.46||||0.285|TWO_SIDED|80.0|-1.85|4.77|||Mixed Models Analysis|||Change from baseline at Day 225||4.77|-1.85|0.2850
71793641|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.55||||0.5778|TWO_SIDED|80.0|-4.14|3.04|||Mixed Models Analysis|||Change from baseline at Day 253||3.04|-4.14|0.5778
71839106|NCT02677805|143186604|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Investigator's In-clinic Assessment||||<0.001
71839107|NCT02677805|143186604|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for Subject's In-clinic Assessment||||<0.001
71839108|NCT02677805|143186605|SUPERIORITY|||||||0.218||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Cochran-Mantel-Haenszel|||Test performed for responders rates at week 20||||0.218
71839109|NCT02677805|143186606|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
71839110|NCT02677805|143186606|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
71892862|NCT00045032|143307018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4755|TWO_SIDED|95.0|0.8|1.11|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.11|0.80|0.4755
71672968|NCT00708552|142863990|SUPERIORITY||Mean Difference (Net)|-1.1||||0.667|TWO_SIDED|95.0|-5.9|3.8|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24||3.8|-5.9|0.667
71672969|NCT00708552|142863990|SUPERIORITY||Mean Difference (Net)|2.7||||0.246|TWO_SIDED|95.0|-1.9|7.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 24||7.2|-1.9|0.246
71793642|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.3||||0.2018|TWO_SIDED|80.0|-1.24|5.85|||Mixed Models Analysis|||Change from baseline at Day 253||5.85|-1.24|0.2018
71793643|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.85||||0.1457|TWO_SIDED|80.0|-0.62|6.32|||Mixed Models Analysis|||Change from baseline at Day 253||6.32|-0.62|0.1457
71793644|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.56||||0.5758|TWO_SIDED|80.0|-4.29|3.18|||Mixed Models Analysis|||Change from baseline at Day 281||3.18|-4.29|0.5758
71793645|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.85||||0.3833|TWO_SIDED|80.0|-2.84|4.55|||Mixed Models Analysis|||Change from baseline at Day 281||4.55|-2.84|0.3833
71793646|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.41||||0.3083|TWO_SIDED|80.0|-2.21|5.02|||Mixed Models Analysis|||Change from baseline at Day 281||5.02|-2.21|0.3083
71793647|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.54||||0.7063|TWO_SIDED|80.0|-5.19|2.11|||Mixed Models Analysis|||Change from baseline at Day 309||2.11|-5.19|0.7063
71793648|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.14||||0.2227|TWO_SIDED|80.0|-1.46|5.74|||Mixed Models Analysis|||Change from baseline at Day 309||5.74|-1.46|0.2227
71672970|NCT00708552|142863991|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.1|0.146
71793649|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0907|TWO_SIDED|80.0|0.15|7.21|||Mixed Models Analysis|||Change from baseline at Day 309||7.21|0.15|0.0907
71672971|NCT00708552|142863991|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.733|TWO_SIDED|95.0|-0.4|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-35mg at Week 24||0.3|-0.4|0.733
71672972|NCT00708552|142863991|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs Donepezil at Week 24||0.1|-0.5|0.145
71672973|NCT00708552|142863992|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.295|TWO_SIDED|95.0|-0.2|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-15mg at Week 24||0.6|-0.2|0.295
71672974|NCT00708552|142863992|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.495|TWO_SIDED|95.0|-0.5|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-35mg at Week 24||0.2|-0.5|0.495
71672975|NCT00708552|142863992|SUPERIORITY||Mean Difference (Net)|-0.3||||0.166|TWO_SIDED|95.0|-0.6|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs Donepezil at Week 24||0.1|-0.6|0.166
71793650|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.17||||0.4799|TWO_SIDED|80.0|-4.23|4.57|||Mixed Models Analysis|||Change from baseline at Day 337||4.57|-4.23|0.4799
71793651|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.2||||0.5237|TWO_SIDED|80.0|-4.54|4.14|||Mixed Models Analysis|||Change from baseline at Day 337||4.14|-4.54|0.5237
71892863|NCT00045032|143307020|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892864|NCT00045032|143307020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.67|0.87|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.87|0.67|
71892865|NCT00045032|143307020|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71793652|NCT02515942|143085763|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.37||||0.5451|TWO_SIDED|80.0|-4.62|3.87|||Mixed Models Analysis|||Change from baseline at Day 337||3.87|-4.62|0.5451
71839111|NCT02677805|143186606|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
71839112|NCT02677805|143186606|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
71892866|NCT00045032|143307020|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.65|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.85|0.65|
71793653|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.15||||0.4609|TWO_SIDED|80.0|-1.79|2.09|||Mixed Models Analysis|||Change from baseline at Day 2||2.09|-1.79|0.4609
71793654|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.3771|TWO_SIDED|80.0|-1.44|2.37|||Mixed Models Analysis|||Change from baseline at Day 2||2.37|-1.44|0.3771
71793655|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.32||||0.4161|TWO_SIDED|80.0|-1.6|2.24|||Mixed Models Analysis|||Change from baseline at Day 2||2.24|-1.60|0.4161
71793656|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.88||||0.9385|TWO_SIDED|80.0|-5.26|-0.49|||Mixed Models Analysis|||Change from baseline at Day 29||-0.49|-5.26|0.9385
71839113|NCT02677805|143186606|SUPERIORITY||||||<|0.001||||||For the testing a hierarchical approach has been applied. The result of this test is considered confirmative if the test of the Primary and all previous Secondary Outcome Measures show a confirmatory result at a one-sided significance level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
71839114|NCT01743807|143186648|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71839115|NCT03344094|143186654|OTHER|changes in subsets paired and unpaired t-tests, ANOVA||||||0.05|||||||ANOVA|||||||0.05
71839116|NCT05415722|143186660|SUPERIORITY||Mean Difference (Final Values)|-11.39|STANDARD_ERROR_OF_MEAN|7.48||0.1303|TWO_SIDED|95.0|-26.178|3.406|||ANCOVA|||Arm 1 compared to Placebo||3.406|-26.178|0.1303
71892867|NCT00045032|143307022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9626|TWO_SIDED|95.0|0.85|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.17|0.85|0.9626
71892868|NCT00045032|143307024|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892869|NCT00045032|143307024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.64|
71839117|NCT05415722|143186660|SUPERIORITY||Mean Difference (Final Values)|-23.47|STANDARD_ERROR_OF_MEAN|7.924||0.0036|TWO_SIDED|95.0|-39.14|-7.799|||ANCOVA|||Arm 2 compared to Placebo||-7.799|-39.140|0.0036
71839118|NCT05415722|143186660|SUPERIORITY||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|7.96|<|0.0001|TWO_SIDED|95.0|-56.545|-25.064|||ANCOVA|||Arm 3 compared to Placebo||-25.064|-56.545|<0.0001
71892870|NCT00045032|143307024|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892871|NCT00045032|143307024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.61|
71892872|NCT00045032|143307026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.45|TWO_SIDED|95.0|0.8|1.1|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.10|0.80|0.4500
71892873|NCT00045032|143307028|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71793657|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.4||||0.5862|TWO_SIDED|80.0|-2.76|1.96|||Mixed Models Analysis|||Change from baseline at Day 29||1.96|-2.76|0.5862
71892874|NCT00045032|143307028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.62|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.|||0.83|0.62|
71892875|NCT00045032|143307028|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71892876|NCT00045032|143307028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.59|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.|||0.79|0.59|
71892877|NCT00045032|143307030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.6823|TWO_SIDED|95.0|0.8|1.15|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.15|0.80|0.6823
71892878|NCT00045032|143307032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.7251|TWO_SIDED|95.0|0.84|1.13|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.|||1.13|0.84|0.7251
71892879|NCT05818124|143307060|OTHER||Difference in Least Squares Mean|-0.48||||0.783|TWO_SIDED|95.0|-3.97|3.0|||ANOVA|||||3.00|-3.97|0.783
71793658|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.48||||0.0875|TWO_SIDED|80.0|0.14|4.82|||Mixed Models Analysis|||Change from baseline at Day 29||4.82|0.14|0.0875
71793659|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.53||||0.4059|TWO_SIDED|80.0|-2.32|3.37|||Mixed Models Analysis|||Change from baseline at Day 57||3.37|-2.32|0.4059
71793660|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.24||||0.286|TWO_SIDED|80.0|-1.58|4.05|||Mixed Models Analysis|||Change from baseline at Day 57||4.05|-1.58|0.2860
71793661|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.71||||0.3727|TWO_SIDED|80.0|-2.1|3.52|||Mixed Models Analysis|||Change from baseline at Day 57||3.52|-2.10|0.3727
71793662|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.91||||0.336|TWO_SIDED|80.0|-1.85|3.66|||Mixed Models Analysis|||Change from baseline at Day 85||3.66|-1.85|0.3360
71793663|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.95||||0.0316|TWO_SIDED|80.0|1.24|6.66|||Mixed Models Analysis|||Change from baseline at Day 85||6.66|1.24|0.0316
71793664|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.04||||0.0762|TWO_SIDED|80.0|0.32|5.76|||Mixed Models Analysis|||Change from baseline at Day 85||5.76|0.32|0.0762
71839119|NCT05415722|143186661|SUPERIORITY||Mean Difference (Final Values)|-31.9|STANDARD_ERROR_OF_MEAN|20.87||0.1289|TWO_SIDED|95.0|-73.17|9.39|||ANCOVA|||Arm 1 compared to Placebo||9.39|-73.17|0.1289
71839120|NCT05415722|143186661|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|21.65||0.179|TWO_SIDED|95.0|-72.08|13.58|||ANCOVA|||Arm 2 compared to Placebo||13.58|-72.08|0.1790
71793665|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0544|TWO_SIDED|80.0|0.75|6.61|||Mixed Models Analysis|||Change from baseline at Day 113||6.61|0.75|0.0544
71793666|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.91||||0.1955|TWO_SIDED|80.0|-0.95|4.77|||Mixed Models Analysis|||Change from baseline at Day 113||4.77|-0.95|0.1955
71793667|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.77||||0.7844|TWO_SIDED|80.0|-4.65|1.12|||Mixed Models Analysis|||Change from baseline at Day 113||1.12|-4.65|0.7844
71793668|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.49||||0.2973|TWO_SIDED|80.0|-2.11|5.08|||Mixed Models Analysis|||Change from baseline at Day 141||5.08|-2.11|0.2973
71793669|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.33||||0.3127|TWO_SIDED|80.0|-2.18|4.84|||Mixed Models Analysis|||Change from baseline at Day 141||4.84|-2.18|0.3127
71793670|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.16||||0.5227|TWO_SIDED|80.0|-3.67|3.36|||Mixed Models Analysis|||Change from baseline at Day 141||3.36|-3.67|0.5227
71839121|NCT05415722|143186661|SUPERIORITY||Mean Difference (Final Values)|-75.7|STANDARD_ERROR_OF_MEAN|21.96||0.0008|TWO_SIDED|95.0|-119.08|-32.23|||ANCOVA|||Arm 3 compared to Placebo||-32.23|-119.08|0.0008
71892880|NCT05818124|143307061|OTHER||Difference in Least Squares Mean|-2.21||||0.032|TWO_SIDED|95.0|-4.21|-0.21|||ANOVA|||||-0.21|-4.21|0.032
71793671|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.63||||0.7643|TWO_SIDED|80.0|-4.54|1.28|||Mixed Models Analysis|||Change from baseline at Day 169||1.28|-4.54|0.7643
71793672|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.38||||0.7331|TWO_SIDED|80.0|-4.25|1.48|||Mixed Models Analysis|||Change from baseline at Day 169||1.48|-4.25|0.7331
71793673|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.25||||0.4557|TWO_SIDED|80.0|-2.59|3.09|||Mixed Models Analysis|||Change from baseline at Day 169||3.09|-2.59|0.4557
71839122|NCT05415722|143186662|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.895||0.0358|TWO_SIDED|95.0|-32.352|-1.128|||ANCOVA|||Arm 4 compared to Placebo||-1.128|-32.352|0.0358
71839123|NCT05415722|143186662|SUPERIORITY||Mean Difference (Final Values)|-43.73|STANDARD_ERROR_OF_MEAN|7.647|<|0.0001|TWO_SIDED|95.0|-58.858|-28.612|||ANCOVA|||Arm 5 compared to Placebo||-28.612|-58.858|<0.0001
71672976|NCT00708552|142863993|SUPERIORITY||Mean Difference (Net)|0.1||||0.847|TWO_SIDED|95.0|-1.1|1.4|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 12||1.4|-1.1|0.847
71672977|NCT00708552|142863993|SUPERIORITY||Mean Difference (Net)|-0.1||||0.833|TWO_SIDED|95.0|-1.4|1.1|||Mixed Models Analysis|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 12||1.1|-1.4|0.833
71672978|NCT00708552|142863993|SUPERIORITY||Mean Difference (Net)|-0.5||||0.443|TWO_SIDED|95.0|-1.6|0.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepzil at Week 12||0.7|-1.6|0.443
71672979|NCT00708552|142863994|SUPERIORITY||Mean Difference (Net)|0.1||||0.32|TWO_SIDED|95.0|-0.1|0.3|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.1|0.320
71672980|NCT00708552|142863994|SUPERIORITY||Mean Difference (Net)|0.0||||0.927|TWO_SIDED|95.0|-0.2|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.2|0.927
71672981|NCT00708552|142863994|SUPERIORITY||Mean Difference (Net)|-0.2||||0.059|TWO_SIDED|95.0|-0.4|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepzil at Week 12||0.0|-0.4|0.059
71672982|NCT00708552|142863995|SUPERIORITY||Mean Difference (Net)|-1.9||||0.257|TWO_SIDED|95.0|-5.2|1.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-15mg at Week 12||1.4|-5.2|0.257
71672983|NCT00708552|142863995|SUPERIORITY||Mean Difference (Net)|0.9||||0.57|TWO_SIDED|95.0|-2.2|4.0|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-35mg at Week 12||4.0|-2.2|0.570
71672984|NCT00708552|142863995|SUPERIORITY||Mean Difference (Net)|3.4||||0.031|TWO_SIDED|95.0|0.3|6.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs Donepzil at Week 12||6.4|0.3|0.031
71793674|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.29||||0.4549|TWO_SIDED|80.0|-2.97|3.55|||Mixed Models Analysis|||Change from baseline at Day 197||3.55|-2.97|0.4549
71672985|NCT00708552|142863996|SUPERIORITY||Mean Difference (Net)|0.2||||0.798|TWO_SIDED|95.0|-1.1|1.5|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.5|-1.1|0.798
71839124|NCT05415722|143186663|SUPERIORITY||Mean Difference (Final Values)|-62.6|STANDARD_ERROR_OF_MEAN|22.09||0.0053|TWO_SIDED|95.0|-106.33|-18.96|||ANCOVA|||Arm 4 compared to Placebo||-18.96|-106.33|0.0053
71672986|NCT00708552|142863996|SUPERIORITY||Mean Difference (Net)|0.1||||0.918|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.918
71672987|NCT00708552|142863996|SUPERIORITY||Mean Difference (Net)|0.1||||0.924|TWO_SIDED|95.0|-1.2|1.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||1.3|-1.2|0.924
71672988|NCT00708552|142863996|SUPERIORITY||Mean Difference (Net)|-0.8||||0.676|TWO_SIDED|95.0|-4.7|3.0|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||3.0|-4.7|0.676
71672989|NCT00708552|142863996|SUPERIORITY||Mean Difference (Net)|3.1||||0.086|TWO_SIDED|95.0|-0.4|6.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||6.7|-0.4|0.086
71672990|NCT00708552|142863996|SUPERIORITY||Mean Difference (Net)|4.2||||0.021|TWO_SIDED|95.0|0.6|7.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 12||7.7|0.6|0.021
71672991|NCT00708552|142863997|SUPERIORITY||Mean Difference (Net)|0.1||||0.908|TWO_SIDED|95.0|-1.5|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12||1.7|-1.5|0.908
71672992|NCT00708552|142863997|SUPERIORITY||Mean Difference (Net)|-0.2||||0.826|TWO_SIDED|95.0|-1.7|1.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.7|0.826
71672993|NCT00708552|142863997|SUPERIORITY||Mean Difference (Net)|-1.2||||0.088|TWO_SIDED|95.0|-2.7|0.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12||0.2|-2.7|0.088
71672994|NCT00708552|142863997|SUPERIORITY||Mean Difference (Net)|-3.6||||0.053|TWO_SIDED|95.0|-7.3|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12||0.0|-7.3|0.053
71672995|NCT00708552|142863997|SUPERIORITY||Mean Difference (Net)|-0.4||||0.848|TWO_SIDED|95.0|-4.0|3.3|||Mixed Models Analysis|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12||3.3|-4.0|0.848
71672996|NCT00708552|142863997|SUPERIORITY||Mean Difference (Net)|4.7||||0.011|TWO_SIDED|95.0|1.1|8.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 12||8.2|1.1|0.011
71672997|NCT00708552|142863998|SUPERIORITY||Mean Difference (Net)|0.1||||0.671|TWO_SIDED|95.0|-0.2|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.3|-0.2|0.671
71672998|NCT00708552|142863998|SUPERIORITY||Mean Difference (Net)|-0.1||||0.413|TWO_SIDED|95.0|-0.4|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.2|-0.4|0.413
71672999|NCT00708552|142863998|SUPERIORITY||Mean Difference (Net)|-0.1||||0.245|TWO_SIDED|95.0|-0.4|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.1|-0.4|0.245
71673000|NCT00708552|142863999|SUPERIORITY||Mean Difference (Net)|0.1||||0.369|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12||0.4|-0.2|0.369
71673001|NCT00708552|142863999|SUPERIORITY||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12||0.4|-0.2|0.550
71793675|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.93||||0.3535|TWO_SIDED|80.0|-2.26|4.13|||Mixed Models Analysis|||Change from baseline at Day 197||4.13|-2.26|0.3535
71793676|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.65||||0.397|TWO_SIDED|80.0|-2.54|3.84|||Mixed Models Analysis|||Change from baseline at Day 197||3.84|-2.54|0.3970
71793677|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.78||||0.2714|TWO_SIDED|80.0|-1.99|5.55|||Mixed Models Analysis|||Change from baseline at Day 225||5.55|-1.99|0.2714
71793678|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.72||||0.2741|TWO_SIDED|80.0|-1.97|5.41|||Mixed Models Analysis|||Change from baseline at Day 225||5.41|-1.97|0.2741
71793679|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.06||||0.5084|TWO_SIDED|80.0|-3.74|3.62|||Mixed Models Analysis|||Change from baseline at Day 225||3.62|-3.74|0.5084
71793680|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.82||||0.1537|TWO_SIDED|80.0|-0.73|6.37|||Mixed Models Analysis|||Change from baseline at Day 253||6.37|-0.73|0.1537
71793681|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.79||||0.2542|TWO_SIDED|80.0|-1.69|5.27|||Mixed Models Analysis|||Change from baseline at Day 253||5.27|-1.69|0.2542
71793682|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.03||||0.6504|TWO_SIDED|80.0|-4.46|2.4|||Mixed Models Analysis|||Change from baseline at Day 253||2.40|-4.46|0.6504
71793683|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.3||||0.3405|TWO_SIDED|80.0|-2.78|5.38|||Mixed Models Analysis|||Change from baseline at Day 281||5.38|-2.78|0.3405
71793684|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.41||||0.2194|TWO_SIDED|80.0|-1.59|6.42|||Mixed Models Analysis|||Change from baseline at Day 281||6.42|-1.59|0.2194
71793685|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3596|TWO_SIDED|80.0|-2.87|5.09|||Mixed Models Analysis|||Change from baseline at Day 281||5.09|-2.87|0.3596
71793686|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.07||||0.5086|TWO_SIDED|80.0|-4.04|3.9|||Mixed Models Analysis|||Change from baseline at Day 309||3.90|-4.04|0.5086
71793687|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.33||||0.2211|TWO_SIDED|80.0|-1.57|6.23|||Mixed Models Analysis|||Change from baseline at Day 309||6.23|-1.57|0.2211
71793688|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.4||||0.2126|TWO_SIDED|80.0|-1.47|6.26|||Mixed Models Analysis|||Change from baseline at Day 309||6.26|-1.47|0.2126
71839125|NCT05415722|143186663|SUPERIORITY||Mean Difference (Final Values)|-69.2|STANDARD_ERROR_OF_MEAN|21.13||0.0014|TWO_SIDED|95.0|-110.97|-27.39|||ANCOVA|||Arm 5 compared to Placebo||-27.39|-110.97|0.0014
71839126|NCT03031470|143186686|SUPERIORITY|||||||0.688|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.688
71673002|NCT00708552|142863999|SUPERIORITY||Mean Difference (Net)|-0.3||||0.082|TWO_SIDED|95.0|-0.5|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12||0.0|-0.5|0.082
71839127|NCT03031470|143186687|SUPERIORITY|||||||0.7|||||||Fisher Exact|Analysis is based on exact Fisher test to compare treatments.||||||0.700
71793689|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.56||||0.2053|TWO_SIDED|80.0|-1.44|6.55|||Mixed Models Analysis|||Change from baseline at Day 337||6.55|-1.44|0.2053
71793690|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.2||||0.2353|TWO_SIDED|80.0|-1.72|6.12|||Mixed Models Analysis|||Change from baseline at Day 337||6.12|-1.72|0.2353
71793691|NCT02515942|143085764|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.36||||0.5471|TWO_SIDED|80.0|-4.24|3.53|||Mixed Models Analysis|||Change from baseline at Day 337||3.53|-4.24|0.5471
71793692|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.74||||0.0913|TWO_SIDED|80.0|-5.38|-0.11|||Mixed Models Analysis|||Change from baseline at Day 2||-0.11|-5.38|0.0913
71793693|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.28||||0.4454|TWO_SIDED|80.0|-2.89|2.33|||Mixed Models Analysis|||Change from baseline at Day 2||2.33|-2.89|0.4454
71793694|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8861|TWO_SIDED|80.0|-0.16|5.08|||Mixed Models Analysis|||Change from baseline at Day 2||5.08|-0.16|0.8861
71793695|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.16||||0.713|TWO_SIDED|80.0|-1.49|3.8|||Mixed Models Analysis|||Change from baseline at Day 29||3.80|-1.49|0.7130
71839128|NCT03031470|143186688|SUPERIORITY||||||>|0.999|||||||Fisher Exact|Treatment groups were compared for frequency of allograft nonfunction using Fisher exact test||||||>0.999
71839129|NCT03031470|143186689|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
71793696|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.37||||0.8759|TWO_SIDED|80.0|-0.26|5.01|||Mixed Models Analysis|||Change from baseline at Day 29||5.01|-0.26|0.8759
71793697|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.22||||0.7256|TWO_SIDED|80.0|-1.39|3.82|||Mixed Models Analysis|||Change from baseline at Day 29||3.82|-1.39|0.7256
71793698|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.17||||0.3111|TWO_SIDED|80.0|-4.22|1.88|||Mixed Models Analysis|||Change from baseline at Day 57||1.88|-4.22|0.3111
71839130|NCT03031470|143186690|SUPERIORITY|||||||0.601|||||||Fisher Exact|||||||0.601
71839131|NCT03031470|143186692|SUPERIORITY|||||||0.574|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for degree of allograft steatosis using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.574
71839132|NCT03031470|143186693|SUPERIORITY|||||||0.843|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of cold ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.843
71673003|NCT00708552|142864000|SUPERIORITY||Mean Difference (Net)|-0.7||||0.417|TWO_SIDED|95.0|-2.4|1.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 12||1.0|-2.4|0.417
71793699|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.7||||0.236|TWO_SIDED|80.0|-4.73|1.34|||Mixed Models Analysis|||Change from baseline at Day 57||1.34|-4.73|0.2360
71793700|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.53||||0.411|TWO_SIDED|80.0|-3.55|2.49|||Mixed Models Analysis|||Change from baseline at Day 57||2.49|-3.55|0.4110
71793701|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.13||||0.5247|TWO_SIDED|80.0|-2.57|2.83|||Mixed Models Analysis|||Change from baseline at Day 85||2.83|-2.57|0.5247
71793702|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.37||||0.0534|TWO_SIDED|80.0|-6.04|-0.7|||Mixed Models Analysis|||Change from baseline at Day 85||-0.70|-6.04|0.0534
71793703|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.5||||0.0475|TWO_SIDED|80.0|-6.18|-0.82|||Mixed Models Analysis|||Change from baseline at Day 85||-0.82|-6.18|0.0475
71793704|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.92||||0.0575|TWO_SIDED|80.0|-7.11|-0.74|||Mixed Models Analysis|||Change from baseline at Day 113||-0.74|-7.11|0.0575
71793705|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.16||||0.1876|TWO_SIDED|80.0|-5.29|0.97|||Mixed Models Analysis|||Change from baseline at Day 113||0.97|-5.29|0.1876
71793706|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.76||||0.7644|TWO_SIDED|80.0|-1.38|4.91|||Mixed Models Analysis|||Change from baseline at Day 113||4.91|-1.38|0.7644
71793707|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.85||||0.0838|TWO_SIDED|80.0|-7.42|-0.28|||Mixed Models Analysis|||Change from baseline at Day 141||-0.28|-7.42|0.0838
71793708|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.38||||0.4444|TWO_SIDED|80.0|-3.89|3.13|||Mixed Models Analysis|||Change from baseline at Day 141||3.13|-3.89|0.4444
71793709|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.47||||0.8977|TWO_SIDED|80.0|-0.04|6.97|||Mixed Models Analysis|||Change from baseline at Day 141||6.97|-0.04|0.8977
71793710|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4917|TWO_SIDED|80.0|-2.92|2.82|||Mixed Models Analysis|||Change from baseline at Day 169||2.82|-2.92|0.4917
71839133|NCT03031470|143186694|SUPERIORITY|||||||0.701|||||||Cochran-Mantel-Haenszel|Reparixin and Control groups will be compared for duration of earm ischemia using Cochran-Mantel-Hensel (CMH) test with control EAD.||||||0.701
71892881|NCT05818124|143307062|OTHER||Difference in Least Squares Mean|0.2||||0.756|TWO_SIDED|95.0|-1.07|1.47|||ANOVA|||||1.47|-1.07|0.756
71673004|NCT00708552|142864000|SUPERIORITY||Mean Difference (Net)|0.3||||0.725|TWO_SIDED|95.0|-1.4|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 12||2.0|-1.4|0.725
71673005|NCT00708552|142864000|SUPERIORITY||Mean Difference (Net)|0.6||||0.506|TWO_SIDED|95.0|-1.1|2.2|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 12||2.2|-1.1|0.506
71673006|NCT00708552|142864000|SUPERIORITY||Mean Difference (Net)|-0.3||||0.723|TWO_SIDED|95.0|-2.3|1.6|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 24||1.6|-2.3|0.723
71793711|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4909|TWO_SIDED|80.0|-2.89|2.79|||Mixed Models Analysis|||Change from baseline at Day 169||2.79|-2.89|0.4909
71793712|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.4992|TWO_SIDED|80.0|-2.82|2.81|||Mixed Models Analysis|||Change from baseline at Day 169||2.81|-2.82|0.4992
71793713|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.09||||0.3285|TWO_SIDED|80.0|-4.25|2.07|||Mixed Models Analysis|||Change from baseline at Day 197||2.07|-4.25|0.3285
71793714|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.45||||0.1568|TWO_SIDED|80.0|-5.57|0.67|||Mixed Models Analysis|||Change from baseline at Day 197||0.67|-5.57|0.1568
71793715|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.36||||0.2867|TWO_SIDED|80.0|-4.46|1.74|||Mixed Models Analysis|||Change from baseline at Day 197||1.74|-4.46|0.2867
71793716|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.93||||0.0798|TWO_SIDED|80.0|-7.51|-0.35|||Mixed Models Analysis|||Change from baseline at Day 225||-0.35|-7.51|0.0798
71793717|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.47||||0.2962|TWO_SIDED|80.0|-5.0|2.06|||Mixed Models Analysis|||Change from baseline at Day 225||2.06|-5.00|0.2962
71793718|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8163|TWO_SIDED|80.0|-1.05|5.98|||Mixed Models Analysis|||Change from baseline at Day 225||5.98|-1.05|0.8163
71793719|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.64||||0.0708|TWO_SIDED|80.0|-6.81|-0.47|||Mixed Models Analysis|||Change from baseline at Day 253||-0.47|-6.81|0.0708
71793720|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.575|TWO_SIDED|80.0|-2.67|3.59|||Mixed Models Analysis|||Change from baseline at Day 253||3.59|-2.67|0.5750
71793721|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.1||||0.956|TWO_SIDED|80.0|1.03|7.17|||Mixed Models Analysis|||Change from baseline at Day 253||7.17|1.03|0.9560
71793722|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.22||||0.1283|TWO_SIDED|80.0|-6.86|0.42|||Mixed Models Analysis|||Change from baseline at Day 281||0.42|-6.86|0.1283
71673007|NCT00708552|142864000|SUPERIORITY||Median Difference (Net)|-0.1||||0.919|TWO_SIDED|95.0|-2.2|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 24||2.0|-2.2|0.919
71673008|NCT00708552|142864000|SUPERIORITY||Mean Difference (Net)|-0.1||||0.896|TWO_SIDED|95.0|-2.3|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 24||2.0|-2.3|0.896
71839134|NCT03031470|143186704|SUPERIORITY|"General survival and graft survival (graft loss will be qualified as an event for graft survival) within 1 year were presented with Kaplan-Mayer curves and survival time median with 95% CI. Treatment groups will be compared using logrank test."||||||0.416|||||||Log Rank|||||||0.416
71673009|NCT00708552|142864001|SUPERIORITY||Mean Difference (Net)|-0.2||||0.594|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.9|0.594
71673010|NCT00708552|142864001|SUPERIORITY||Mean Difference (Net)|0.2||||0.523|TWO_SIDED|95.0|-0.5|0.9|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-35mg at Week 24||0.9|-0.5|0.523
71673011|NCT00708552|142864001|SUPERIORITY||Mean Difference (Net)|0.3||||0.429|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||CSDD Total score, Placebo Vs Donepezil at Week 24||1.0|-0.4|0.429
71793723|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.28||||0.2085|TWO_SIDED|80.0|-5.88|1.33|||Mixed Models Analysis|||Change from baseline at Day 281||1.33|-5.88|0.2085
71793724|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.94||||0.6335|TWO_SIDED|80.0|-2.61|4.49|||Mixed Models Analysis|||Change from baseline at Day 281||4.49|-2.61|0.6335
71793725|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.64||||0.1778|TWO_SIDED|80.0|-6.31|1.03|||Mixed Models Analysis|||Change from baseline at Day 309||1.03|-6.31|0.1778
71793726|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.7||||0.4027|TWO_SIDED|80.0|-4.33|2.94|||Mixed Models Analysis|||Change from baseline at Day 309||2.94|-4.33|0.4027
71793727|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.94||||0.757|TWO_SIDED|80.0|-1.64|5.53|||Mixed Models Analysis|||Change from baseline at Day 309||5.53|-1.64|0.7570
71793728|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.9||||0.1132|TWO_SIDED|80.0|-8.03|0.23|||Mixed Models Analysis|||Change from baseline at Day 337||0.23|-8.03|0.1132
71793729|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.71||||0.1965|TWO_SIDED|80.0|-6.8|1.37|||Mixed Models Analysis|||Change from baseline at Day 337||1.37|-6.80|0.1965
71793730|NCT02515942|143085765|SUPERIORITY|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment\*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.18||||0.6471|TWO_SIDED|80.0|-2.85|5.21|||Mixed Models Analysis|||Change from baseline at Day 337||5.21|-2.85|0.6471
71793731|NCT00666757|143085781|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.||||0.26
71793732|NCT00666757|143085782|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.||||0.07
71892882|NCT05818124|143307063|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-23.21|23.21||||||||23.21|-23.21|
71892883|NCT05818124|143307064|OTHER|Clopper and Pearson binomial method|Difference in percentage|-2.86|||||TWO_SIDED|95.0|-25.78|20.27||||||||20.27|-25.78|
71673012|NCT00708552|142864002|SUPERIORITY||Mean Difference (Net)|0.0||||0.966|TWO_SIDED|95.0|-0.8|0.8|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-15mg at Week 24||0.8|-0.8|0.966
71673013|NCT00708552|142864002|SUPERIORITY||Mean Difference (Net)|0.3||||0.505|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-35mg at Week 24||1.1|-0.5|0.505
71673014|NCT00708552|142864002|SUPERIORITY||Mean Difference (Net)|0.8||||0.044|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||MMSE Total score, Placebo Vs Donepezil at Week 24||1.6|0.0|0.044
71673015|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 12||0.5|-0.5|0.869
71673016|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.2||||0.5|TWO_SIDED|95.0|-0.4|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 12||0.8|-0.4|0.500
71673017|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 12||0.8|-0.1|0.140
71673018|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.0||||0.91|TWO_SIDED|95.0|-0.6|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 24||0.5|-0.6|0.910
71673019|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.1||||0.774|TWO_SIDED|95.0|-0.5|0.7|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 24||0.7|-0.5|0.774
71673020|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 24||0.5|-0.7|0.726
71793733|NCT00666757|143085783|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.||||0.03
71793734|NCT00666757|143085784|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.09
71793735|NCT00666757|143085785|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.||||0.001
71839135|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and gender as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female)."||||0.2
71839136|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||||||Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p\<0.05.|Regression, Logistic|2-factor logistic regression with age and treatment sequence as factors||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years)."||||=0.001
71839137|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and baseline disease severity as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe)."||||0.29
71673021|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|-0.8||||0.292|TWO_SIDED|95.0|-2.2|0.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 12||0.7|-2.2|0.292
71673022|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.0||||0.946|TWO_SIDED|95.0|-1.3|1.4|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 12||1.4|-1.3|0.946
71793736|NCT00666757|143085786|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
71793737|NCT00666757|143085787|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.001
71793738|NCT00666757|143085788|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.003
71793739|NCT00666757|143085789|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.01
71793740|NCT00666757|143085790|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.02
71793741|NCT00666757|143085791|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.20
71793742|NCT00666757|143085792|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
71793743|NCT00666757|143085793|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.03
71839138|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and distribution phenotype (localised, widespread) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread)."||||0.55
71839139|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||||||Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, \>3 mm diameter): p=0.25; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and plaque size as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, \>3 mm diameter)."||||0.25
71839140|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||||||Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, \>0.75 mm) effect: p=0.41; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and skin thickness phenotype as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, \>0.75 mm)."||||0.41
71839141|NCT02310646|143186729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, \>40 years of age) effect: p=0.20; threshold for statistical significance: p\<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and onset phenotype (≤40 years of age, \>40 years of age) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, \>40 years of age)."||||0.20
71673023|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.2||||0.802|TWO_SIDED|95.0|-1.3|1.6|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 12||1.6|-1.3|0.802
71673024|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|-0.4||||0.636|TWO_SIDED|95.0|-2.1|1.3|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 24||1.3|-2.1|0.636
71673025|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|-0.3||||0.752|TWO_SIDED|95.0|-2.0|1.5|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 24||1.5|-2.0|0.752
71673026|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|-0.1||||0.92|TWO_SIDED|95.0|-1.9|1.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 24||1.7|-1.9|0.920
71793744|NCT00666757|143085794|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.||||0.002
71793745|NCT00666757|143085795|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
71793746|NCT00666757|143085796|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||Between group P-value|ANCOVA|||||||0.07
71793747|NCT00666757|143085797|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||Between group P-value|ANCOVA|||||||0.34
71793748|NCT00666757|143085798|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.02
71793749|NCT00666757|143085799|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.01
71793750|NCT00666757|143085800|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.97
71793751|NCT00666757|143085801|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.32
71793752|NCT00666757|143085802|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Between group P-value|ANCOVA|||Transformed absolute score||||0.12
71793753|NCT00666757|143085803|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||Between group P-value|ANCOVA|||Transformed Absolute Score||||0.16
71793754|NCT00666757|143085804|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.002
71673027|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.0||||0.972|TWO_SIDED|95.0|-0.7|0.6|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 12||0.6|-0.7|0.972
71673028|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.3||||0.378|TWO_SIDED|95.0|-0.4|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 12||0.9|-0.4|0.378
71793755|NCT00666757|143085805|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.||||0.53
71793756|NCT01231581|143085806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.352|TWO_SIDED|95.0|0.66|1.32|||Log Rank||Hazard ratios are estimated using a Pike estimator.|||1.32|0.66|0.352
71673029|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.3||||0.346|TWO_SIDED|95.0|-0.3|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 12||0.9|-0.3|0.346
71673030|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.1||||0.72|TWO_SIDED|95.0|-0.6|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 24||0.9|-0.6|0.720
71673031|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.2||||0.598|TWO_SIDED|95.0|-0.6|1.0|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 24||1.0|-0.6|0.598
71673032|NCT00708552|142864003|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 24||1.1|-0.5|0.480
71673033|NCT01017874|142864023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.217|TWO_SIDED|95.0|0.63|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.63|0.217
71673034|NCT01017874|142864024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.788|TWO_SIDED|95.0|0.68|1.31|||Wilcoxon (Mann-Whitney)|||||1.31|0.68|0.788
71673035|NCT01017874|142864027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.252|TWO_SIDED|95.0|0.63|1.14|||Wilcoxon (Mann-Whitney)|||||1.14|0.63|0.252
71793757|NCT01649375|143085826|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0967|TWO_SIDED|95.0|0.9|3.67|||Regression, Logistic|Missing ASAS responses considered nonresponders||||3.67|0.90|0.0967
71793758|NCT01649375|143085826|SUPERIORITY||Odds Ratio (OR)|4.38|||<|0.0001|TWO_SIDED|95.0|2.14|8.96|||Regression, Logistic|Missing ASAS responses considered nonresponders||||8.96|2.14|<.0001
71793759|NCT01649375|143085827|SUPERIORITY||Odds Ratio (OR)|2.99||||0.0194|TWO_SIDED|95.0|1.19|7.48|||Regression, Logistic|Missing ASAS responses considered nonresponders||||7.48|1.19|0.0194
71793760|NCT01649375|143085827|SUPERIORITY||Odds Ratio (OR)|5.07|||<|0.0004|TWO_SIDED|95.0|2.06|12.44|||Regression, Logistic|Missing ASAS responses considered nonresponders||||12.44|2.06|<.0004
71793761|NCT01649375|143085828|SUPERIORITY||Mean Difference (Net)|0.54|||<|0.0001|TWO_SIDED|95.0|0.41|0.71|||Mixed Models Analysis|||||0.71|0.41|<0.0001
71793762|NCT01649375|143085828|SUPERIORITY||Mean Difference (Net)|0.49|||<|0.0001|TWO_SIDED|95.0|0.37|0.64|||Mixed Models Analysis|||||0.64|0.37|<0.0001
71793763|NCT01649375|143085829|SUPERIORITY||Odds Ratio (OR)|6.13||||0.0003|TWO_SIDED|95.0|2.31|16.26|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.26|2.31|0.0003
71793764|NCT01649375|143085829|SUPERIORITY||Odds Ratio (OR)|9.15|||<|0.0001|TWO_SIDED|95.0|3.47|24.12|||Regression, Logistic|Missing ASAS responses considered nonresponders||||24.12|3.47|<.0001
71793765|NCT01649375|143085830|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.353|<|0.0001|TWO_SIDED|95.0|-1.77|-0.37|||Mixed Models Analysis|||||-0.37|-1.77|<0.0001
71793766|NCT01649375|143085830|SUPERIORITY||Mean Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.353||0.0002|TWO_SIDED|95.0|-2.04|-0.65|||Mixed Models Analysis|||||-0.65|-2.04|0.0002
71793767|NCT01649375|143085831|SUPERIORITY||Mean Difference (Net)|2.84|STANDARD_ERROR_OF_MEAN|1.108||0.011|TWO_SIDED|95.0|0.66|5.03|||Mixed Models Analysis|||||5.03|0.66|0.0110
71793768|NCT01649375|143085831|SUPERIORITY||Mean Difference (Net)|4.14|STANDARD_ERROR_OF_MEAN|1.105||0.0002|TWO_SIDED|95.0|1.96|6.32|||Mixed Models Analysis|||||6.32|1.96|0.0002
71673036|NCT01017874|142864028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.952|TWO_SIDED|95.0|0.53|1.32|||Wilcoxon (Mann-Whitney)|||||1.32|0.53|0.952
71673037|NCT03809663|142864046|SUPERIORITY||Odds Ratio (OR)|1.686||||0.56|TWO_SIDED|95.0|0.29|9.809||Nominal p-value|Regression, Logistic|||||9.809|0.290|0.56
71673038|NCT03809663|142864046|SUPERIORITY||Odds Ratio (OR)|1.011||||0.99|TWO_SIDED|95.0|0.135|7.551||Nominal p-value|Regression, Logistic|||||7.551|0.135|0.99
71673039|NCT03809663|142864046|SUPERIORITY||Odds Ratio (OR)|2.146||||0.38|TWO_SIDED|95.0|0.39|11.8||Nominal p-value|Regression, Logistic|||||11.800|0.390|0.38
71673040|NCT03809663|142864047|SUPERIORITY||Odds Ratio (OR)|0.982||||0.97|TWO_SIDED|95.0|0.344|2.803||Nominal p-value|Regression, Logistic|||||2.803|0.344|0.97
71673041|NCT03809663|142864047|SUPERIORITY||Odds Ratio (OR)|1.217||||0.7|TWO_SIDED|95.0|0.441|3.356||Nominal p-value|Regression, Logistic|||||3.356|0.441|0.70
71793769|NCT01649375|143085832|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.748||0.0096|TWO_SIDED|95.0|-3.43|-0.48|||Mixed Models Analysis|||||-0.48|-3.43|0.0096
71839142|NCT02310646|143186730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007).~Threshold for statistical significance: p\<0.05."|Wilcoxon Rank Sum Test|Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.||Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.||||0.007
71839143|NCT02310646|143186731|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.||||<0.001
71839144|NCT02310646|143186731|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.||||<0.001
71673042|NCT03809663|142864047|SUPERIORITY||Odds Ratio (OR)|0.73||||0.58|TWO_SIDED|95.0|0.243|2.197||Nominal p-value|Regression, Logistic|||||2.197|0.243|0.58
71673043|NCT00386360|142864072|SUPERIORITY_OR_OTHER||LS Mean Difference|0.231||||0.7096|TWO_SIDED|95.0|-0.995|1.458|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.458|-0.995|0.7096
71673044|NCT00386360|142864073|SUPERIORITY_OR_OTHER||LS Mean Difference|0.543||||0.2973|TWO_SIDED|95.0|-0.485|1.571|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.571|-0.485|0.2973
71793770|NCT01649375|143085832|SUPERIORITY||Mean Difference (Net)|-2.63|STANDARD_ERROR_OF_MEAN|0.743||0.0005|TWO_SIDED|95.0|-4.09|-1.16|||Mixed Models Analysis|||||-1.16|-4.09|0.0005
71793771|NCT01649375|143085833|SUPERIORITY||Odds Ratio (OR)|4.28||||0.0325|TWO_SIDED|95.0|1.13|16.21|||Regression, Logistic|Missing ASAS responses considered nonresponders||||16.21|1.13|0.0325
71793772|NCT01649375|143085833|SUPERIORITY||Odds Ratio (OR)|3.91||||0.0471|TWO_SIDED|95.0|1.02|15.01|||Regression, Logistic|Missing ASAS responses considered nonresponders||||15.01|1.02|0.0471
71839145|NCT04204265|143186845|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71839146|NCT04204265|143186846|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71839147|NCT04204265|143186847|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71839148|NCT03931174|143186865|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Odds Ratio (OR)|2.41|STANDARD_ERROR_OF_MEAN|0.53||0.097|TWO_SIDED|95.0|0.85|6.81||CM Exposure is reported as the estimated proportion of providers delivering 10 or more CM sessions to at least one patient in a mixed model accounting for nesting.|Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||6.81|0.85|0.097
71793773|NCT01762943|143085838|SUPERIORITY|||||||0.27|||||||repeated measures ANOVA|F=1.40, df=2,26||||||.27
71793774|NCT01762943|143085839|SUPERIORITY|||||||0.018|||||||repeated measures ANOVA|F=6.29, df=1,28||||||.018
71793775|NCT00159588|143085879|SUPERIORITY|||||||0.056||||||Between-group analysis|Kruskal-Wallis|||Kruskal-Wallis test||||0.056
71839149|NCT03931174|143186866|SUPERIORITY|Unit of analysis is the provider level. All 186 providers (95 ATTC, 91 E-ATTC) who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.31||0.02|TWO_SIDED|95.0|0.11|1.32|||t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||1.32|0.11|0.02
71839150|NCT03931174|143186867|SUPERIORITY|Unit of analysis is the organization-level. Total number of organizations included in the analysis is 28 (14 ATTC, 14 E-ATTC).|Chi-square test statistic value|0.662||||0.43|TWO_SIDED||||||Chi-squared|Pearson Chi-Square||These analyses are unadjusted.||||0.430
71839151|NCT03931174|143186868|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.695|STANDARD_ERROR_OF_MEAN|0.313||0.034|TWO_SIDED|95.0|-1.3|-0.08|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||-0.08|-1.30|.034
71793776|NCT00159588|143085880|SUPERIORITY|Between-group analysis||||||0.012||||||Between-group analysis|t-test, 2 sided|Kruskal-Wallis test||Kruskal-Wallis test||||0.012
71793777|NCT01232920|143085953|SUPERIORITY_OR_OTHER|||||||0.09|||||||Fisher Exact|||||||0.09
71793778|NCT02211131|143085957|OTHER||Hazard Ratio (HR)|0.75||||0.07|TWO_SIDED|80.0|0.58|0.96||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.96|0.58|0.070
71793779|NCT02211131|143085958|OTHER||Hazard Ratio (HR)|0.76||||0.092|TWO_SIDED|80.0|0.6|0.97||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.97|0.60|0.092
71793780|NCT02211131|143085960|OTHER||Treatment Difference|4.3||||0.594|TWO_SIDED|80.0|-6.9|15.3||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||An 80% approximate exact CI for between-arm differences in binary rate is calculated using Wilson's score method with continuity correction.|||15.3|-6.9|0.594
71793781|NCT02211131|143085961|OTHER||Treatment Difference|14.4||||0.003|TWO_SIDED|80.0|7.4|21.6||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||80% exact CI for binary rate of each arm is calculated using the Clopper Pearson method.|||21.6|7.4|0.003
71793782|NCT02211131|143085966|OTHER||Hazard Ratio (HR)|0.54||||0.05|TWO_SIDED|80.0|0.36|0.81||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)|||0.81|0.36|0.050
71793783|NCT00755131|143085973|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Sample size determination was based on a t-test assuming a normal distribution with non-equal variance with the mean and standard deviation for the experimental group (postinfarction patients) of HMGB1 levels equal to 15 ± 7 and 2 ± 1 ng/dl for the control group derived from a previous study, respectively. The required sample size was calculated to be 30 subjects per group to detect on the size of one SD with α value of 0.05 (two-sided) and power (1 - β) of 0.8.||||<0.05
71793784|NCT00755131|143085974|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71793785|NCT00755131|143085975|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71793786|NCT02120950|143085977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.7||||0.548|TWO_SIDED|95.0|-2.9|1.6|||ANCOVA|||||1.6|-2.9|0.5480
71793787|NCT02120950|143085978|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7402|TWO_SIDED|95.0|-3.1|4.3|||Cochran-Mantel-Haenszel|||||4.3|-3.1|0.7402
71793788|NCT02120950|143085980|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.0682|TWO_SIDED|95.0|0.0|0.2|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.2|0.0|0.0682
71677263|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.7998||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Watery Eyes||||0.7998
71793789|NCT02120950|143085981|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1||||0.164|TWO_SIDED|95.0|-0.1|0.3|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham - AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.|||0.3|-0.1|0.1640
71793790|NCT02120950|143085984|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-5.6||||0.2348|TWO_SIDED|95.0|-14.9|3.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 5||3.7|-14.9|0.2348
71793791|NCT02120950|143085984|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-2.2||||0.6877|TWO_SIDED|95.0|-13.1|8.6|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 10||8.6|-13.1|0.6877
71793792|NCT02120950|143085984|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-4.0||||0.4556|TWO_SIDED|95.0|-14.5|6.5|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 15||6.5|-14.5|0.4556
71793793|NCT02120950|143085985|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|1.7||||0.5372|TWO_SIDED|95.0|-3.7|7.2|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 5||7.2|-3.7|0.5372
71793794|NCT02120950|143085985|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|0.6||||0.7569|TWO_SIDED|95.0|-3.4|4.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 10||4.7|-3.4|0.7569
71793795|NCT02120950|143085985|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-0.6||||0.7402|TWO_SIDED|95.0|-4.3|3.1|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 15||3.1|-4.3|0.7402
71892884|NCT05818124|143307065|OTHER|Clopper and Pearson exact binomial method|Difference in Percentage|-8.57|||||TWO_SIDED|95.0|-30.26|13.38||||||||13.38|-30.26|
71892885|NCT05818124|143307066|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
71892886|NCT05818124|143307067|OTHER|Clopper and Pearson binomial method|Difference in percentage|-5.71|||||TWO_SIDED|95.0|-25.18|13.97||||||||13.97|-25.18|
71892887|NCT05818124|143307068|OTHER|Clopper and Pearson binomial method|Difference in percentage|-8.57|||||TWO_SIDED|95.0|-27.63|10.5||||||||10.50|-27.63|
71793796|NCT02120950|143085986|SUPERIORITY_OR_OTHER_LEGACY||treatment difference in %|-6.0||||0.3244|TWO_SIDED|95.0|-17.8|5.9|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|||5.9|-17.8|0.3244
71793797|NCT02120950|143085987|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1||||0.7109|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.||0.6|-0.9|0.7109
71793798|NCT02120950|143085988|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.1||||0.8355|TWO_SIDED|95.0|-9.2|11.3|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.||11.3|-9.2|0.8355
71793799|NCT02120950|143085989|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7||||0.5069|TWO_SIDED|95.0|-2.9|1.4|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham - AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.||1.4|-2.9|0.5069
71793800|NCT02120950|143085990|SUPERIORITY_OR_OTHER_LEGACY||Difference %|-0.6||||0.8423|TWO_SIDED|95.0|-6.3|5.1||The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12.|Cochran-Mantel-Haenszel||CI is based on the treatment difference in % (AFL-sham - AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12.|||5.1|-6.3|0.8423
71892888|NCT05818124|143307071|OTHER||Hazard Ratio (HR)|0.82||||0.3102|TWO_SIDED|95.0|0.51|1.33|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.33|0.51|0.3102
71892889|NCT05818124|143307072|OTHER||Hazard Ratio (HR)|0.55||||0.0779|TWO_SIDED|95.0|0.27|1.14|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.14|0.27|0.0779
71892890|NCT05818124|143307075|OTHER||Difference in Least Squares Mean|-3.79||||0.045|TWO_SIDED|95.0|-7.47|-0.1|||ANOVA|||||-0.10|-7.47|0.045
71892891|NCT05818124|143307076|OTHER||Difference in Least Squares Mean|-2.56||||0.226|TWO_SIDED|95.0|-6.81|1.69|||ANOVA|||||1.69|-6.81|0.226
71677264|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.1229||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Swollen Eyelids||||0.1229
71892892|NCT05818124|143307077|OTHER||Difference in Least Squares Mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
71892893|NCT05818124|143307078|OTHER||Difference in Least Squares Mean|0.74||||0.609|TWO_SIDED|95.0|-2.19|3.66|||ANOVA|||||3.66|-2.19|0.609
71892894|NCT05818124|143307079|OTHER|Difference in Least Squares Mean|Difference in Least Squares Mean|0.34||||0.614|TWO_SIDED|95.0|-1.04|1.72|||ANOVA|||||1.72|-1.04|0.614
71892895|NCT05818124|143307080|OTHER||Difference in Least Squares Mean|0.37||||0.608|TWO_SIDED|95.0|-1.09|1.83|||ANOVA|||||1.83|-1.09|0.608
71892896|NCT05818124|143307081|OTHER||Difference in Least Squares Mean|0.43||||0.288|TWO_SIDED|95.0|-0.39|1.25|||ANOVA|||||1.25|-0.39|0.288
71892897|NCT05818124|143307082|OTHER||Difference in Least Squares Mean|0.09||||0.842|TWO_SIDED|95.0|-0.8|0.97|||ANOVA|||||0.97|-0.80|0.842
71892898|NCT05818124|143307085|OTHER||Hazard Ratio (HR)|0.31||||0.0042|TWO_SIDED|95.0|0.14|0.71|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||0.71|0.14|0.0042
71892899|NCT05818124|143307086|OTHER||Hazard Ratio (HR)|0.69||||0.329|TWO_SIDED|95.0|0.33|1.46|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.46|0.33|0.3290
71892900|NCT05818124|143307087|OTHER||Hazard Ratio (HR)|0.6||||0.1502|TWO_SIDED|95.0|0.27|1.34|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||1.34|0.27|0.1502
71793801|NCT02424383|143085991|OTHER||||||||||||||||||Freedom from Target LesionRevascularization (TLR) were reported through 12 months with frequency counts, percentages and 95% confidence intervals from exact binomial test. In addition, Kaplan-Meier tables and curves were created.|||
71793802|NCT02424383|143085992|OTHER||||||||||||||||||Freedom from composite of safety events from the time following the index procedure through 30 days post procedure were reported with frequency counts, percentages and 95% confidence intervals from exact binomial test. Kaplan-Meier tables and curves were also calculated.|||
71793803|NCT00117559|143085999|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
71793804|NCT02016482|143086000|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.001|TWO_SIDED|95.0|32.8|53.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||For US regulatory purposes, ranked first secondary endpoint.||53.6|32.8|< 0.001
71793805|NCT02016482|143086001|SUPERIORITY_OR_OTHER||Difference in percentage|42.0|||<|0.001|TWO_SIDED|95.0|30.8|53.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.||53.2|30.8|< 0.001
71793806|NCT02016482|143086002|SUPERIORITY_OR_OTHER||LS Mean|-44.8|||<|0.001|TWO_SIDED|95.0|-53.5|-36.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.||-36.0|-53.5|< 0.001
71793807|NCT02016482|143086003|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.008|TWO_SIDED|95.0|1.8|11.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.||11.3|1.8|0.008
71793808|NCT02016482|143086004|SUPERIORITY_OR_OTHER||LS Mean Percent Change|-2.6|||<|0.001|TWO_SIDED|95.0|-3.3|-2.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.||-2.0|-3.3|< 0.001
71793809|NCT02016482|143086005|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.6|-2.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.||-2.2|-3.6|< 0.001
71793810|NCT02016482|143086006|SUPERIORITY_OR_OTHER||Difference in percentage|57.9||||0.002|TWO_SIDED|95.0|33.8|82.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.||82.0|33.8|0.002
71793811|NCT02016482|143086007|SUPERIORITY_OR_OTHER||Difference in percentage|43.3|||<|0.001|TWO_SIDED|95.0|31.3|55.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||55.2|31.3|< 0.001
71793812|NCT02016482|143086008|SUPERIORITY_OR_OTHER||Difference in percentage|44.8|||<|0.001|TWO_SIDED|95.0|33.2|56.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||56.5|33.2|< 0.001
71793813|NCT02016482|143086009|SUPERIORITY_OR_OTHER||Difference in percentage|18.6|||<|0.001|TWO_SIDED|95.0|10.6|26.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.6|10.6|< 0.001
71793814|NCT02016482|143086010|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.001|TWO_SIDED|95.0|25.0|46.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||46.9|25.0|< 0.001
71793815|NCT02016482|143086011|SUPERIORITY_OR_OTHER||Difference in percentage|13.3|||<|0.001|TWO_SIDED|95.0|6.5|20.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||20.0|6.5|<0.001
71793816|NCT02016482|143086012|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5|||<|0.001|TWO_SIDED|95.0|-4.3|-2.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.8|-4.3|< 0.001
71793817|NCT02016482|143086013|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.9|||<|0.001|TWO_SIDED|95.0|-46.9|-30.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.8|-46.9|< 0.001
71892901|NCT05818124|143307088|OTHER||Hazard Ratio (HR)|1.32||||0.4865|TWO_SIDED|95.0|0.59|2.92|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate|||2.92|0.59|0.4865
71793818|NCT02016482|143086014|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.001|TWO_SIDED|95.0|-33.5|-23.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-23.7|-33.5|< 0.001
71892902|NCT05818124|143307091|OTHER||Difference in Least Squares Mean|-4.79||||0.313|TWO_SIDED|95.0|-14.36|4.78|||ANOVA|||||4.78|-14.36|0.313
71892903|NCT05818124|143307092|OTHER||Difference in Least Squares Mean|-6.87||||0.138|TWO_SIDED|95.0|-16.11|2.36|||ANOVA|||||2.36|-16.11|0.138
71892904|NCT05818124|143307093|OTHER||Difference in LS mean|0.74||||0.706|TWO_SIDED|95.0|-3.26|4.74|||ANOVA|||||4.74|-3.26|0.706
71892905|NCT05818124|143307094|OTHER||Difference in LS mean|-1.58||||0.367|TWO_SIDED|95.0|-5.1|1.95|||ANOVA|||||1.95|-5.10|0.367
71892906|NCT05818124|143307100|OTHER||Difference in LS Mean|-4.14||||0.177|TWO_SIDED|95.0|-10.2|1.92|||ANOVA|||||1.92|-10.20|0.177
71892907|NCT05818124|143307101|OTHER||Difference in LS mean|-0.97||||0.395|TWO_SIDED|95.0|-3.24|1.29|||ANOVA|||||1.29|-3.24|0.395
71673045|NCT00386360|142864074|SUPERIORITY_OR_OTHER||LS Mean Difference|0.485||||0.1275|TWO_SIDED|95.0|-0.141|1.11|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.110|-0.141|0.1275
71673046|NCT00386360|142864075|SUPERIORITY_OR_OTHER||LS Mean Difference|0.664||||0.336|TWO_SIDED|95.0|-0.697|2.025|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.025|-0.697|0.3360
71677265|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.3907||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Red Eyelids||||0.3907
71793819|NCT02016482|143086015|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|||<|0.001|TWO_SIDED|95.0|-58.3|-41.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-41.9|-58.3|< 0.001
71793820|NCT02016482|143086016|SUPERIORITY_OR_OTHER||Difference in percentage|7.4||||0.004|TWO_SIDED|95.0|2.4|12.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||12.4|2.4|0.004
71793821|NCT02016482|143086017|SUPERIORITY_OR_OTHER||Difference in percentage|18.5|||<|0.001|TWO_SIDED|95.0|10.1|26.8||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||26.8|10.1|< 0.001
71793822|NCT02016482|143086018|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5|||<|0.001|TWO_SIDED|95.0|-3.1|-1.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-1.9|-3.1|< 0.001
71793823|NCT02016482|143086019|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.2|||<|0.001|TWO_SIDED|95.0|-50.0|-30.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-30.4|-50.0|< 0.001
71793824|NCT02016482|143086020|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.5|||<|0.001|TWO_SIDED|95.0|-23.6|-15.3||Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.|ANCOVA|||||-15.3|-23.6|< 0.001
71793825|NCT02016482|143086021|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1|||<|0.001|TWO_SIDED|95.0|-10.0|-6.1||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-6.1|-10.0|< 0.001
71793826|NCT02016482|143086022|SUPERIORITY_OR_OTHER||LS Mean Difference|-71.2|||<|0.001|TWO_SIDED|95.0|-87.3|-55.0||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-55.0|-87.3|< 0.001
71793827|NCT02016482|143086023|SUPERIORITY_OR_OTHER||Difference in percentage|51.1|||<|0.001|TWO_SIDED|95.0|38.6|63.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 75||63.5|38.6|< 0.001
71793828|NCT02016482|143086023|SUPERIORITY_OR_OTHER||Difference in percentage|52.5|||<|0.001|TWO_SIDED|95.0|39.9|65.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 50||65.0|39.9|< 0.001
71793829|NCT02016482|143086023|SUPERIORITY_OR_OTHER||Difference in percentage|40.9|||<|0.001|TWO_SIDED|95.0|29.0|52.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 90||52.9|29.0|< 0.001
71793830|NCT02016482|143086023|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.001|TWO_SIDED|95.0|15.8|36.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||PASI 100||36.9|15.8|< 0.001
71793831|NCT02016482|143086024|SUPERIORITY_OR_OTHER||Difference in percentage|52.2|||<|0.001|TWO_SIDED|95.0|40.8|63.7||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||63.7|40.8|< 0.001
71793832|NCT02016482|143086025|SUPERIORITY_OR_OTHER||Difference in percentage|24.8|||<|0.001|TWO_SIDED|95.0|15.3|34.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||34.3|15.3|< 0.001
71793833|NCT02016482|143086026|SUPERIORITY_OR_OTHER||Difference in percentage|90.4|||<|0.001|TWO_SIDED|95.0|72.5|108.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||||108.3|72.5|< 0.001
71892908|NCT05818124|143307113|OTHER|Difference in least squares mean|Difference in least squares means|-0.94||||0.11|TWO_SIDED|95.0|-2.1|0.22|||ANOVA|||||0.22|-2.10|0.110
71793834|NCT02016482|143086027|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.1|||<|0.001|TWO_SIDED|95.0|-13.9|-8.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-8.4|-13.9|< 0.001
71673047|NCT00386360|142864076|SUPERIORITY_OR_OTHER||LS Mean Difference|0.334||||0.4565|TWO_SIDED|95.0|-0.551|1.219|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.219|-0.551|0.4565
71673048|NCT00386360|142864077|SUPERIORITY_OR_OTHER||LS Mean Difference|0.611||||0.0614|TWO_SIDED|95.0|-0.03|1.252|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.252|-0.030|0.0614
71673049|NCT00386360|142864078|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.9212|TWO_SIDED|95.0|-1.258|1.138|||ANOVA|LS means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||1.138|-1.258|0.9212
71673050|NCT00386360|142864079|SUPERIORITY_OR_OTHER||LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|2.231|4.31|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||4.310|2.231|<0.0001
71673051|NCT00386360|142864080|SUPERIORITY_OR_OTHER||LS Mean Difference|1.444|||<|0.0001|TWO_SIDED|95.0|0.748|2.14|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.140|0.748|<0.0001
71673052|NCT00386360|142864081|SUPERIORITY_OR_OTHER||LS Mean Difference|1.408||||0.0036|TWO_SIDED|95.0|0.469|2.348|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.348|0.469|0.0036
71673053|NCT00386360|142864082|SUPERIORITY_OR_OTHER||LS Mean Difference|1.458||||0.0087|TWO_SIDED|95.0|0.375|2.541|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||2.541|0.375|0.0087
71677266|NCT03226769|142873141|OTHER|The null hypothesis is that there is no difference between the two devices, TrueTear™ and Thermalon.||||||0.0336||||||Statistically significant (p \< 0.05) and trending significant (p \< 0.10) for within-group or between-group changes from baseline at Day 30. Between-group P-value was calculated using Wilcoxon rank-sum test.|Wilcoxon rank-sum test|||Crusty Eyelids||||0.0336
71793835|NCT02016482|143086028|SUPERIORITY_OR_OTHER||LS Mean Difference|-80.6|||<|0.001|TWO_SIDED|95.0|-97.9|-63.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-63.3|-97.9|< 0.001
71793836|NCT02016482|143086029|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.9|||<|0.001|TWO_SIDED|95.0|-64.0|-37.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-37.8|-64.0|< 0.001
71793837|NCT02016482|143086030|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|||<|0.001|TWO_SIDED|95.0|-73.1|-42.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-42.4|-73.1|< 0.001
71793838|NCT02016482|143086031|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.1|-0.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-0.7|-1.1|< 0.001
71839152|NCT03931174|143186869|SUPERIORITY|Analyses are at the patient-level. All patients who enrolled in the study are included in the analysis.|Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.314||0.27|TWO_SIDED|95.0|-0.82|0.41|||Mixed Models Analysis|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.41|-0.82|0.27
71839153|NCT03931174|143186870|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.191||0.011|TWO_SIDED|95.0|-0.88|0.12||Means were compared between conditions in an independent-samples T-test.|t-test, 2 sided|T-test adjusted for inequality of variances||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.12|-0.88|.011
71839154|NCT03931174|143186871|SUPERIORITY|Analyses are at the provider-level. Only those providers who completed the post-implementation survey (at the end of the 9-month implementation phase) were included in the analysis.|Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.232||0.218|TWO_SIDED|95.0|-0.75|0.17||Means of leadership engagement scores were compared between conditions in an independent-samples T-test.|t-test, 2 sided|||These analyses are unadjusted. The primary outcomes paper will report both unadjusted and adjusted analyses.||0.17|-0.75|.218
71673054|NCT00386360|142864083|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.54||||0.0002|TWO_SIDED|95.0|-59.957|-19.123|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-19.123|-59.957|0.0002
71673055|NCT00386360|142864084|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.269|||<|0.0001|TWO_SIDED|95.0|-51.3|-29.238|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||-29.238|-51.300|<0.0001
71673056|NCT00386360|142864085|SUPERIORITY_OR_OTHER||LS Mean Difference|0.092||||0.1385|TWO_SIDED|95.0|-0.03|0.213|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.||0.213|-0.030|0.1385
71673057|NCT02230904|142864087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.115|STANDARD_DEVIATION|1.635|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
71673058|NCT02230904|142864094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442|STANDARD_DEVIATION|0.895|||TWO_SIDED|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.||||
71839155|NCT03852472|143186892|OTHER||% Difference (Avacopan - Placebo)|-8.4||||0.1321|TWO_SIDED|95.0|-18.7|2.4||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment).|Cochran-Mantel-Haenszel|||||2.4|-18.7|0.1321
71839156|NCT03852472|143186892|OTHER||% Difference (Avacopan - Placebo)|4.3||||0.4503|TWO_SIDED|95.0|-6.9|15.5||P-values are obtained from a CMH test stratified by stratification factors Hurley Stage (Stage II vs III), and anti-TNF drug use (Treatment naive vs Previous treatment)|Cochran-Mantel-Haenszel|||||15.5|-6.9|0.4503
71673059|NCT00789373|142864116|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||6e-05|TWO_SIDED|95.0|0.49|0.79|||Log Rank|||900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).||0.79|0.49|0.00006
71673060|NCT00789373|142864117|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0002|TWO_SIDED|95.0|0.51|0.81|||Log Rank|||||0.81|0.51|0.0002
71673061|NCT00789373|142864118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0195|TWO_SIDED|95.0|0.64|0.96||The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.|Log Rank||Unadjusted HR from Cox model with treatment as the only cofactor.|Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.||0.96|0.64|0.0195
71673062|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||Adjusted GMT/GMT Ratio based on analysis of covariance (ANCOVA) model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.18|0.87|
71673063|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|0.96|||||TWO_SIDED|95.0|0.82|1.12|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.12|0.82|
71839157|NCT03852472|143186893|OTHER||Least Squares Mean|0.6|STANDARD_ERROR_OF_MEAN|1.17||0.5784|TWO_SIDED|95.0|-1.7|2.9|||Mixed model for repeated measures|||||2.9|-1.7|0.5784
71839158|NCT03852472|143186893|OTHER||Least Squares Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.17||0.2253|TWO_SIDED|95.0|-3.7|0.9|||Mixed effects model for repeated measure|||||0.9|-3.7|0.2253
71839159|NCT03161028|143186946|SUPERIORITY|||||||0.51||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||For the model evaluating the primary outcome (change in T25FW), T25FW was transformed to walking speed by dividing 25 feet by the completion time in seconds (ft/sec). Any participants who were unable to complete the T25FW at any timepoint after baseline were assigned a value of 199 seconds, a statistical technique known as Winsorizing.||||0.51
71839160|NCT03161028|143186947|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
71839161|NCT03161028|143186948|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
71839162|NCT03161028|143186949|SUPERIORITY|||||||0.084|||||||Mixed Models Analysis|||||||0.084
71839163|NCT03161028|143186950|SUPERIORITY|||||||0.134|||||||Chi-squared|||||||0.134
71793839|NCT02016482|143086032|SUPERIORITY_OR_OTHER||LS Mean Difference|-27.7|||<|0.001|TWO_SIDED|95.0|-33.9|-21.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-21.6|-33.9|< 0.001
71839164|NCT03492216|143186952|SUPERIORITY||Risk Difference (RD)|7.6||||0.0025|TWO_SIDED|95.0|2.7|12.5|||Regression, Logistic||adjusted risk difference for non-hazardous alcohol use, alcohol incentive groups compared to no alcohol incentive groups. logistic regression model adjusted for INH incentive arm, participant sex, and study site.|||12.5|2.7|0.0025
71673064|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.81|1.1|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H1N1 (California)||1.10|0.81|
71793840|NCT02016482|143086033|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|||<|0.001|TWO_SIDED|95.0|-7.8|-4.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-4.5|-7.8|< 0.001
71793841|NCT02016482|143086034|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.001|TWO_SIDED|95.0|7.1|24.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0||24.3|7.1|< 0.001
71793842|NCT02016482|143086034|SUPERIORITY_OR_OTHER||Difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|16.7|37.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Cochran-Mantel-Haenszel|||DLQI = 0/1||37.4|16.7|< 0.001
71793843|NCT02016482|143086035|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.416|TWO_SIDED|95.0|-1.0|2.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Absenteeism||2.5|-1.0|0.416
71793844|NCT02016482|143086035|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-22.9|-11.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Presenteeism||-11.6|-22.9|< 0.001
71793845|NCT02016482|143086035|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-21.0|-9.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Overall work impairment||-9.3|-21.0|< 0.001
71793846|NCT02016482|143086035|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.4|||<|0.001|TWO_SIDED|95.0|-27.3|-15.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Activity impairment||-15.4|-27.3|< 0.001
71793847|NCT02016482|143086036|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.1|0.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||0.2|0.1|< 0.001
71793848|NCT02016482|143086037|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5||||0.012|TWO_SIDED|95.0|1.2|9.8||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||9.8|1.2|0.012
71793849|NCT02016482|143086038|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1||||0.025|TWO_SIDED|95.0|-2.0|-0.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS anxiety score||-0.1|-2.0|0.025
71793850|NCT02016482|143086038|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3||||0.005|TWO_SIDED|95.0|-2.3|-0.4||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS depression score||-0.4|-2.3|0.005
71793851|NCT02016482|143086039|SUPERIORITY_OR_OTHER||Difference in percentage|2.5||||0.164|TWO_SIDED|95.0|-0.9|6.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell \[2007\]).|Chi-squared|||||6|-0.9|0.164
71793852|NCT02016482|143086040|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-3.4|-2.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||||-2.1|-3.4|< 0.001
71793853|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.74||||0|TWO_SIDED|95.0|0.68|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Non-smoker)||0.82|0.68|0.000
71793854|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.32||||0|TWO_SIDED|95.0|1.14|1.52|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Ex-smoker)||1.52|1.14|0.000
71793855|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.04||||0|TWO_SIDED|95.0|0.93|1.17|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Smoker)||1.17|0.93|0.000
71793856|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.95||||0.755|TWO_SIDED|95.0|0.8|1.13|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.80|0.755
71793857|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.32||||0.426|TWO_SIDED|95.0|0.95|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)||1.83|0.95|0.426
71793858|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.93||||0.93|TWO_SIDED|95.0|0.77|1.12|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Smoker)||1.12|0.77|0.930
71793859|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.78||||0|TWO_SIDED|95.0|0.72|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Non-smoker)||0.84|0.72|0.000
71793860|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.42|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)||1.42|1.10|0.000
71793861|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.98|1.19|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Smoker)||1.19|0.98|0.000
71793862|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.98||||0.755|TWO_SIDED|95.0|0.84|1.14|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)||1.14|0.84|0.755
71892909|NCT05818124|143307114|OTHER||Difference in least squares mean|-1.6||||0.09|TWO_SIDED|95.0|-3.47|0.27|||ANOVA|||||0.27|-3.47|0.090
71892910|NCT01232946|143307133|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
71892911|NCT01232946|143307134|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
71892912|NCT01232946|143307135|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||||||0.80
71673065|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|0.94|||||TWO_SIDED|95.0|0.77|1.13|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.13|0.77|
71673066|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.91|1.32|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.32|0.91|
71673067|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.97|1.41|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|A/H3N2 (Hong Kong)||1.41|0.97|
71673068|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.15|0.87|
71673069|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|1.09|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
71673070|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|1.1|||||TWO_SIDED|95.0|0.95|1.26|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Brisbane||1.26|0.95|
71673071|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.09|0.80|
71793863|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.13||||0.426|TWO_SIDED|95.0|0.84|1.52|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)||1.52|0.84|0.426
71793864|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.98||||0.93|TWO_SIDED|95.0|0.81|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Smoker)||1.12|0.81|0.930
71793865|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.79||||0|TWO_SIDED|95.0|0.74|0.84|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Non-smoker)||0.84|0.74|0.000
71673072|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|0.91|||||TWO_SIDED|95.0|0.78|1.07|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.07|0.78|
71673073|NCT03321968|142864126|SUPERIORITY||Adjusted GMT Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.15|||||Adjusted GMT/GMT Ratio based on ANCOVA model with vaccine lot as main effect and the baseline titer (log-transformed) as covariate.|B/Phuket||1.15|0.84|
71673074|NCT00232739|142864166|SUPERIORITY_OR_OTHER||Primary analysis posterior probability|0.9926||||||||||The primary analysis of comparing Sirolimus stent with POBA using Bayesian regression model yields that Sirolimus is superior to POBA in reducing the BAR risk.|Bayesian regression model|Multi-level Bayesian regression model was used in the secondary analysis|Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.|Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.||||
71673075|NCT00463047|142864182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.18|0.29|||Mixed effects ANOVA|Crossover analysis||The statistical hypothesis to be tested was:HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and oxycodone (OXY), respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.29|0.18|<0.0001
71673076|NCT00463047|142864183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.0081|TWO_SIDED|95.0|0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.05|0.01|0.0081
71673077|NCT00463047|142864184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.05|0.13||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.13|0.05|<0.0001
71793866|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.19||||0|TWO_SIDED|95.0|1.08|1.32|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)||1.32|1.08|0.000
71793867|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|1.08|1.26|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Smoker)||1.26|1.08|0.000
71793868|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.82||||0.755|TWO_SIDED|95.0|0.6|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)||1.13|0.60|0.755
71793869|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.48||||0.426|TWO_SIDED|95.0|0.82|2.52|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)||2.52|0.82|0.426
71793870|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.0||||0.93|TWO_SIDED|95.0|0.7|1.4|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Smoker)||1.40|0.70|0.930
71892913|NCT00733902|143307148|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.015|TWO_SIDED|95.0|-1.32|-0.14|||ANCOVA|||Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-1.32|0.015
71892914|NCT00733902|143307148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|-1.43|-0.25|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-1.43|0.005
71892915|NCT00733902|143307148|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.78|-0.61|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.61|-1.78|<0.001
71892916|NCT00733902|143307149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.29||0.009|TWO_SIDED|95.0|-1.32|-0.19|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-1.32|0.009
71793871|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.54||||0|TWO_SIDED|95.0|0.49|0.6|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Non-smoker)||0.60|0.49|0.000
71793872|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.51||||0|TWO_SIDED|95.0|1.29|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Ex-smoker)||1.76|1.29|0.000
71793873|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.72||||0|TWO_SIDED|95.0|1.54|1.93|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.93|1.54|0.000
71793874|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.91||||0.755|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Non-smoker)||1.17|0.72|0.755
71793875|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|1.25||||0.426|TWO_SIDED|95.0|0.78|1.95|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Ex-smoker)||1.95|0.78|0.426
71793876|NCT03441633|143086045|SUPERIORITY||Odds Ratio (OR)|0.92||||0.93|TWO_SIDED|95.0|0.7|1.2|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)||1.20|0.70|0.930
71793877|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.99||||0|TWO_SIDED|95.0|0.9|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (No intake)||1.09|0.90|0.000
71793878|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.98|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Moderate intake)||1.25|0.98|0.000
71793879|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.52||||0.164|TWO_SIDED|95.0|0.94|2.45|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Risk consumption)||2.45|0.94|0.164
71793880|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.03||||0.826|TWO_SIDED|95.0|0.87|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (No intake)||1.22|0.87|0.826
71793881|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.16||||0.19|TWO_SIDED|95.0|0.94|1.43|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Moderate intake)||1.43|0.94|0.190
71793882|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.58||||0.526|TWO_SIDED|95.0|0.18|1.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Risk consumption)||1.57|0.18|0.526
71793883|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (No intake)||0.91|0.77|0.000
71793884|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|1.01|1.24|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Moderate intake)||1.24|1.01|0.000
71793885|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.17||||0.164|TWO_SIDED|95.0|0.76|1.83|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Risk consumption)||1.83|0.76|0.164
71793886|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.09||||0.826|TWO_SIDED|95.0|0.95|1.26|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (No intake)||1.26|0.95|0.826
71793887|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.93||||0.19|TWO_SIDED|95.0|0.77|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)||1.13|0.77|0.190
71793888|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.26||||0.526|TWO_SIDED|95.0|0.62|2.65|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)||2.65|0.62|0.526
71793889|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.28|1.45|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (No intake)||1.45|1.28|0.000
71793890|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.24||||0|TWO_SIDED|95.0|1.14|1.35|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Moderate intake)||1.35|1.14|0.000
71793891|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.98|1.95|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Risk consumption)||1.95|0.98|0.164
71793892|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.04||||0.826|TWO_SIDED|95.0|0.76|1.41|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (No intake)||1.41|0.76|0.826
71793893|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.22||||0.19|TWO_SIDED|95.0|0.82|1.76|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)||1.76|0.82|0.190
71793894|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.21||||0.526|TWO_SIDED|95.0|0.17|4.5|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)||4.50|0.17|0.526
71793895|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.16|1.42|||Chi-squared|||Warfarin vs. Apixaban in naive participants (No intake)||1.42|1.16|0.000
71793896|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.25||||0|TWO_SIDED|95.0|1.1|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Moderate intake)||1.43|1.10|0.000
71793897|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.92||||0.164|TWO_SIDED|95.0|0.49|1.64|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Risk consumption)||1.64|0.49|0.164
71793898|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|1.06||||0.826|TWO_SIDED|95.0|0.84|1.34|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (No intake)||1.34|0.84|0.826
71793899|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.91||||0.19|TWO_SIDED|95.0|0.66|1.23|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Moderate intake)||1.23|0.66|0.190
71793900|NCT03441633|143086046|SUPERIORITY||Odds Ratio (OR)|0.64||||0.526|TWO_SIDED|95.0|0.09|2.36|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Risk consumption)||2.36|0.09|0.526
71793901|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.36||||0|TWO_SIDED|95.0|1.2|1.53|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.53|1.20|0.000
71793902|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.01||||0.014|TWO_SIDED|95.0|0.89|1.15|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.15|0.89|0.014
71793903|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.87||||0|TWO_SIDED|95.0|0.77|0.99|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.99|0.77|0.000
71793904|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.86||||0|TWO_SIDED|95.0|0.75|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.97|0.75|0.000
71793905|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.85||||0.013|TWO_SIDED|95.0|0.74|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.97|0.74|0.013
71793906|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.05||||0.157|TWO_SIDED|95.0|0.84|1.31|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.31|0.84|0.157
71793907|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.03||||0.124|TWO_SIDED|95.0|0.82|1.29|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.82|0.124
71793908|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.77||||0.062|TWO_SIDED|95.0|0.61|0.96|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.61|0.062
71793909|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.98||||0.079|TWO_SIDED|95.0|0.78|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.22|0.78|0.079
71793910|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.09||||0.14|TWO_SIDED|95.0|0.86|1.38|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.38|0.86|0.140
71793911|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|1.17|1.45|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.45|1.17|0.000
71793912|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.97||||0.014|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)||1.09|0.87|0.014
71839165|NCT03492216|143186953|SUPERIORITY||Risk Difference (RD)|-0.2||||0.9435|TWO_SIDED|95.0|-7.0|6.5|||Regression, Logistic||adjusted risk difference for \>90% INH adherence, INH incentive group compared to no INH incentives. logistic regression model adjusted for alcohol incentive arm, participant sex and study site.|||6.5|-7.0|0.9435
71793913|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.91|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.12|0.91|0.000
71793914|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.94||||0|TWO_SIDED|95.0|0.85|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)||1.05|0.85|0.000
71793915|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.83||||0.013|TWO_SIDED|95.0|0.74|0.93|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)||0.93|0.74|0.013
71793916|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.92||||0.157|TWO_SIDED|95.0|0.76|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.13|0.76|0.157
71793917|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.98||||0.124|TWO_SIDED|95.0|0.81|1.2|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.20|0.81|0.124
71839166|NCT03492216|143186956|SUPERIORITY||Risk Difference (RD)|-2.5||||0.26|TWO_SIDED|95.0|-6.8|1.9|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 2 (escalating incentives; EtG tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||1.9|-6.8|0.26
71839167|NCT03492216|143186956|SUPERIORITY||Risk Difference (RD)|0.7||||0.7|TWO_SIDED|95.0|-2.8|4.1|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 3 (escalating incentives; IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.1|-2.8|0.70
71839168|NCT03492216|143186956|SUPERIORITY||Risk Difference (RD)|1.3||||0.42|TWO_SIDED|95.0|-1.9|4.5|||Regression, Logistic||adjusted risk different for HIV viral suppression at 12 months, Arm 4 (escalating incentives; EtG and IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site.|||4.5|-1.9|0.42
71793918|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.79||||0.062|TWO_SIDED|95.0|0.65|0.96|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||0.96|0.65|0.062
71793919|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.23||||0.079|TWO_SIDED|95.0|1.02|1.48|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.48|1.02|0.079
71793920|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.21||||0.14|TWO_SIDED|95.0|0.99|1.49|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.49|0.99|0.140
71793921|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.96||||0|TWO_SIDED|95.0|0.88|1.05|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)||1.05|0.88|0.000
71793922|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.91||||0.014|TWO_SIDED|95.0|0.84|0.99|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.99|0.84|0.014
71793923|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.83||||0|TWO_SIDED|95.0|0.76|0.9|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)||0.90|0.76|0.000
71793924|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.84||||0|TWO_SIDED|95.0|0.77|0.91|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)||0.91|0.77|0.000
71793925|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.92||||0.013|TWO_SIDED|95.0|0.85|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.00|0.85|0.013
71793926|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.03||||0.157|TWO_SIDED|95.0|0.68|1.54|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.54|0.68|0.157
71793927|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.84||||0.124|TWO_SIDED|95.0|0.53|1.29|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.29|0.53|0.124
71793928|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.75||||0.062|TWO_SIDED|95.0|0.48|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.13|0.48|0.062
71673078|NCT00463047|142864185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|0.3|0.45||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.45|0.30|<0.0001
71673079|NCT00463047|142864186|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|0.2|0.35||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.35|0.20|<0.0001
71677267|NCT01516008|142873157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|76.35|||<|0.001|TWO_SIDED|95.0|51.0|101.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||101.7|51.0|<0.001
71793929|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.88||||0.079|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.33|0.57|0.079
71793930|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.05||||0.14|TWO_SIDED|95.0|0.67|1.59|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.59|0.67|0.140
71793931|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.39||||0|TWO_SIDED|95.0|0.32|0.47|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)||0.47|0.32|0.000
71793932|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.84||||0.014|TWO_SIDED|95.0|0.73|0.97|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)||0.97|0.73|0.014
71793933|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.7||||0|TWO_SIDED|95.0|1.51|1.91|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)||1.91|1.51|0.000
71793934|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.86||||0|TWO_SIDED|95.0|1.65|2.1|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)||2.10|1.65|0.000
71793935|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.94||||0.013|TWO_SIDED|95.0|0.82|1.08|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)||1.08|0.82|0.013
71793936|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.35||||0.157|TWO_SIDED|95.0|1.0|1.8|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)||1.80|1.00|0.157
71793937|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|1.41||||0.124|TWO_SIDED|95.0|1.04|1.88|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)||1.88|1.04|0.124
71793938|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.76||||0.062|TWO_SIDED|95.0|0.55|1.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)||1.05|0.55|0.062
71793939|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.92||||0.079|TWO_SIDED|95.0|0.67|1.26|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)||1.26|0.67|0.079
71793940|NCT03441633|143086047|SUPERIORITY||Odds Ratio (OR)|0.81||||0.14|TWO_SIDED|95.0|0.56|1.15|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)||1.15|0.56|0.140
71839169|NCT03945292|143186981|SUPERIORITY||Difference|-66.81|STANDARD_ERROR_OF_MEAN|5.107|<|0.0001|TWO_SIDED|95.0|-77.18|-56.45||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|Mixed model repeated measures (MMRM)|NAFLD=non-alcoholic fatty liver disease; NSH=non-alcoholic steatohepatitis||||-56.45|-77.18|< 0.0001
71793941|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.25|0.91|0.000
71793942|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.38||||0.202|TWO_SIDED|95.0|0.58|3.23|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.23|0.58|0.202
71793943|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.98||||0|TWO_SIDED|95.0|0.88|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.09|0.88|0.000
71793944|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.84||||0.003|TWO_SIDED|95.0|0.76|0.93|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.93|0.76|0.003
71793945|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.82||||0.083|TWO_SIDED|95.0|0.66|1.03|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.03|0.66|0.083
71793946|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.99||||0.011|TWO_SIDED|95.0|0.68|6.18|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.18|0.68|0.011
71793947|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.89||||0.227|TWO_SIDED|95.0|0.75|1.06|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.06|0.75|0.227
71793948|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.47|1.03|0.000
71677268|NCT01516008|142873157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|90.6|||<|0.001|TWO_SIDED|95.0|65.1|116.1||P-value is adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|||116.1|65.1|<0.001
71793949|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.01||||0|TWO_SIDED|95.0|0.88|1.16|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.16|0.88|0.000
71793950|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.22||||0.202|TWO_SIDED|95.0|0.58|2.66|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.66|0.58|0.202
71793951|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.95||||0|TWO_SIDED|95.0|0.87|1.04|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.04|0.87|0.000
71793952|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.87||||0.003|TWO_SIDED|95.0|0.8|0.95|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||0.95|0.80|0.003
71793953|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.97||||0.083|TWO_SIDED|95.0|0.8|1.17|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.17|0.80|0.083
71793954|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.06||||0.011|TWO_SIDED|95.0|0.02|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||1.05|0.02|0.011
71793955|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.84||||0.227|TWO_SIDED|95.0|0.72|0.98|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||0.98|0.72|0.227
71793956|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.16||||0|TWO_SIDED|95.0|0.99|1.35|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.35|0.99|0.000
71793957|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.63||||0|TWO_SIDED|95.0|1.47|1.82|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.82|1.47|0.000
71793958|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.7||||0.202|TWO_SIDED|95.0|0.98|3.25|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||3.25|0.98|0.202
71793959|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.29||||0|TWO_SIDED|95.0|1.2|1.38|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.38|1.20|0.000
71793960|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.94||||0.003|TWO_SIDED|95.0|0.88|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.00|0.88|0.003
71793961|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.86||||0.083|TWO_SIDED|95.0|0.56|1.28|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.28|0.56|0.083
71793962|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.49||||0.011|TWO_SIDED|95.0|0.13|8.58|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||8.58|0.13|0.011
71793963|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.04||||0.227|TWO_SIDED|95.0|0.75|1.42|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.42|0.75|0.227
71839170|NCT03945292|143186981|SUPERIORITY||Difference|-90.03|STANDARD_ERROR_OF_MEAN|5.26|<|0.0001|TWO_SIDED|95.0|-100.72|-79.34||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-79.34|-100.72|< 0.0001
71839171|NCT03945292|143186981|SUPERIORITY||Difference|-97.57|STANDARD_ERROR_OF_MEAN|5.24|<|0.0001|TWO_SIDED|95.0|-108.21|-86.94||From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.|MMRM|||||-86.94|-108.21|< 0.0001
71839172|NCT03945292|143186985|SUPERIORITY||Least Squares (LS) Mean Difference|-129.31|STANDARD_ERROR_OF_MEAN|36.409||0.0021|TWO_SIDED|95.0|-205.52|-53.11||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-53.11|-205.52|0.0021
71839173|NCT03945292|143186985|SUPERIORITY||LS Mean Difference|-124.03|STANDARD_ERROR_OF_MEAN|37.207||0.0035|TWO_SIDED|95.0|-201.9|-46.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-46.15|-201.9|0.0035
71793964|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.12||||0|TWO_SIDED|95.0|0.81|1.55|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||1.55|0.81|0.000
71793965|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.5||||0|TWO_SIDED|95.0|1.28|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m\^2 Normal)||1.76|1.28|0.000
71793966|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.04||||0.202|TWO_SIDED|95.0|0.36|2.73|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\<18.5 kg per m\^2 Underweight)||2.73|0.36|0.202
71793967|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.28||||0|TWO_SIDED|95.0|1.15|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (25 - 30 kg per m\^2 Overweight)||1.43|1.15|0.000
71793968|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.95||||0.003|TWO_SIDED|95.0|0.86|1.06|||Chi-squared|||Warfarin vs. Apixaban in naive participants (\>30 kg per m\^2 Obese)||1.06|0.86|0.003
71793969|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.27||||0.083|TWO_SIDED|95.0|0.95|1.68|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m\^2 Normal)||1.68|0.95|0.083
71793970|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|0.18|6.21|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\<18.5 kg per m\^2 Underweight)||6.21|0.18|0.011
71793971|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.92||||0.227|TWO_SIDED|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m\^2 Overweight)||1.17|0.72|0.227
71793972|NCT03441633|143086048|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.5|0.87|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (\>30 kg per m\^2 Obese)||0.87|0.50|0.000
71793973|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|0.68||||0|TWO_SIDED|95.0|0.61|0.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants||0.75|0.61|0.000
71839174|NCT03945292|143186985|SUPERIORITY||LS Mean Difference|-140.58|STANDARD_ERROR_OF_MEAN|30.906||0.0002|TWO_SIDED|95.0|-205.27|-75.89||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.|ANCOVA|||||-75.89|-205.27|0.0002
71793974|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|0.85||||0.052|TWO_SIDED|95.0|0.63|1.15|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||1.15|0.63|0.052
71793975|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|0.73||||0|TWO_SIDED|95.0|0.67|0.8|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants||0.80|0.67|0.000
71793976|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|0.79||||0.052|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.03|0.61|0.052
71793977|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|1.26||||0|TWO_SIDED|95.0|1.17|1.36|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants||1.36|1.17|0.000
71793978|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|0.74||||0.052|TWO_SIDED|95.0|0.45|1.27|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.27|0.45|0.052
71793979|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||Warfarin vs. Apixaban in naive participants||1.21|0.95|0.000
71793980|NCT03441633|143086049|SUPERIORITY||Odds Ratio (OR)|0.57||||0.052|TWO_SIDED|95.0|0.4|0.84|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.84|0.40|0.052
71839175|NCT03945292|143186987|SUPERIORITY||LS Mean Difference|-98.07|STANDARD_ERROR_OF_MEAN|20.291||0.0001|TWO_SIDED|95.0|-140.53|-55.6||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-55.6|-140.53|0.0001
71839176|NCT03945292|143186987|SUPERIORITY||LS Mean Difference|-109.56|STANDARD_ERROR_OF_MEAN|21.616|<|0.0001|TWO_SIDED|95.0|-154.81|-64.32||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-64.32|-154.81|< 0.0001
71839177|NCT03945292|143186987|SUPERIORITY||LS Mean Difference|-118.04|STANDARD_ERROR_OF_MEAN|17.16|<|0.0001|TWO_SIDED|95.0|-153.95|-82.12||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.|ANCOVA|||||-82.12|-153.95|< 0.0001
71793981|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0|TWO_SIDED|95.0|-0.26|-0.17|||ANOVA|||Dabigatran vs. Apixaban in naive participants (HAS - BLED)||-0.17|-0.26|0.000
71793982|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.001|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)||-0.01|-0.18|0.001
71839178|NCT03945292|143186989|SUPERIORITY||LS Mean Difference|-180.7|STANDARD_ERROR_OF_MEAN|74.087||0.0247|TWO_SIDED|95.0|-335.77|-25.64||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-25.64|-335.77|0.0247
71839179|NCT03945292|143186989|SUPERIORITY||LS Mean Difference|-163.79|STANDARD_ERROR_OF_MEAN|73.513||0.0382|TWO_SIDED|95.0|-317.65|-9.93||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-9.93|-317.65|0.0382
71839180|NCT03945292|143186989|SUPERIORITY||LS Mean Difference|-193.2|STANDARD_ERROR_OF_MEAN|63.089||0.0064|TWO_SIDED|95.0|-325.25|-61.15||Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.|ANCOVA|||||-61.15|-325.25|0.0064
71892917|NCT00733902|143307149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.54|-0.41|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.54|<0.001
71793983|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0|TWO_SIDED|95.0|-0.23|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)||-0.15|-0.23|0.000
71793984|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.001|TWO_SIDED|95.0|-0.19|-0.04|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)||-0.04|-0.19|0.001
71793985|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|0.5||||0|TWO_SIDED|95.0|0.47|0.53|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (HAS - BLED)||0.53|0.47|0.000
71793986|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.001|TWO_SIDED|95.0|-0.32|-0.02|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)||-0.02|-0.32|0.001
71793987|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|0.17||||0|TWO_SIDED|95.0|0.12|0.23|||ANOVA|||Warfarin vs. Apixaban in naive participants (HAS - BLED)||0.23|0.12|0.000
71793988|NCT03441633|143086050|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.001|TWO_SIDED|95.0|-0.37|-0.1|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (HAS - BLED)||-0.10|-0.37|0.001
71793989|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0|TWO_SIDED|95.0|-0.24|-0.12|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHADS2)||-0.12|-0.24|0.000
71793990|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.35|-0.12|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHADS2)||-0.12|-0.35|0.000
71793991|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0|TWO_SIDED|95.0|-0.28|-0.18|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHADS2)||-0.18|-0.28|0.000
71793992|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0|TWO_SIDED|95.0|-0.31|-0.11|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)||-0.11|-0.31|0.000
71793993|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|0.21||||0|TWO_SIDED|95.0|0.17|0.25|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHADS2)||0.25|0.17|0.000
71793994|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0|TWO_SIDED|95.0|-0.7|-0.3|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHADS2)||-0.30|-0.70|0.000
71677269|NCT01516008|142873158|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
71793995|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|0.08||||0|TWO_SIDED|95.0|0.01|0.14|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHADS2)||0.14|0.01|0.000
71793996|NCT03441633|143086051|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0|TWO_SIDED|95.0|-0.54|-0.2|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHADS2)||-0.20|-0.54|0.000
71793997|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0|TWO_SIDED|95.0|-0.42|-0.26|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.26|-0.42|0.000
71793998|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0|TWO_SIDED|95.0|-0.46|-0.19|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.19|-0.46|0.000
71793999|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0|TWO_SIDED|95.0|-0.45|-0.32|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.32|-0.45|0.000
71794000|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0|TWO_SIDED|95.0|-0.39|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.15|-0.39|0.000
71794001|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|0.19||||0|TWO_SIDED|95.0|0.14|0.24|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)||0.24|0.14|0.000
71794002|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0|TWO_SIDED|95.0|-0.86|-0.37|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.37|-0.86|0.000
71794003|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0|TWO_SIDED|95.0|-0.18|-0.01|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)||-0.01|-0.18|0.000
71794004|NCT03441633|143086052|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0|TWO_SIDED|95.0|-0.64|-0.21|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)||-0.21|-0.64|0.000
71794005|NCT03441633|143086053|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|0.77|5.3|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants||5.30|0.77|0.008
71794006|NCT03441633|143086053|SUPERIORITY||Odds Ratio (OR)|0.62||||0.008|TWO_SIDED|95.0|0.33|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants||1.12|0.33|0.008
71677270|NCT01516008|142873158|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center||||||<0.001
71794007|NCT03441633|143086053|SUPERIORITY||Odds Ratio (OR)|0.55||||0.008|TWO_SIDED|95.0|0.2|1.99|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants||1.99|0.20|0.008
71794008|NCT03441633|143086053|SUPERIORITY||Odds Ratio (OR)|0.39||||0.008|TWO_SIDED|95.0|0.18|0.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants||0.86|0.18|0.008
71794009|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.14|1.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Poor adherence)||1.75|1.14|0.000
71794010|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.67||||0|TWO_SIDED|95.0|0.55|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Good adherence)||0.82|0.55|0.000
71794011|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.03|2.01|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Over adherence)||2.01|0.03|0.000
71794012|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.58||||0|TWO_SIDED|95.0|1.23|2.04|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Poor adherence)||2.04|1.23|0.000
71794013|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.44||||0|TWO_SIDED|95.0|0.34|0.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Good adherence)||0.57|0.34|0.000
71677271|NCT01516008|142873159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
71794014|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.43||||0|TWO_SIDED|95.0|0.02|3.73|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Over adherence)||3.73|0.02|0.000
71794015|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.66||||0|TWO_SIDED|95.0|0.52|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Poor adherence)||0.84|0.52|0.000
71794016|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.14||||0|TWO_SIDED|95.0|0.95|1.36|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Good adherence)||1.36|0.95|0.000
71794017|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.52||||0|TWO_SIDED|95.0|0.06|3.41|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Over adherence)||3.41|0.06|0.000
71794018|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.65||||0|TWO_SIDED|95.0|0.5|0.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)||0.85|0.50|0.000
71794019|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.11||||0|TWO_SIDED|95.0|0.9|1.37|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)||1.37|0.90|0.000
71794020|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.07||||0|TWO_SIDED|95.0|0.22|5.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)||5.85|0.22|0.000
71794021|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|3.37||||0|TWO_SIDED|95.0|2.86|3.99|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Poor adherence)||3.99|2.86|0.000
71794022|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.11||||0|TWO_SIDED|95.0|0.09|0.13|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Good adherence)||0.13|0.09|0.000
71794023|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.34||||0|TWO_SIDED|95.0|0.11|1.52|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Over adherence)||1.52|0.11|0.000
71794024|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.23||||0|TWO_SIDED|95.0|0.78|1.91|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)||1.91|0.78|0.000
71794025|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.01||||0|TWO_SIDED|95.0|0.0|0.09|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Good adherence)||0.09|0.00|0.000
71794026|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|2.07||||0|TWO_SIDED|95.0|0.07|18.0|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Over adherence)||18.00|0.07|0.000
71794027|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.58||||0|TWO_SIDED|95.0|0.45|0.75|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Poor adherence)||0.75|0.45|0.000
71839181|NCT01098812|143187044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.0|STANDARD_DEVIATION|75.0|<|0.0001|ONE_SIDED|90.0|25.0|||Primary study endpoint; therefore, no adjustment for multiple comparisons. The planned alpha level for testing was 0.025.|t-test, 1 sided|||Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is \<= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is \> the control. There is 80% power to detect \>=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.|||25|<0.0001
71839182|NCT01098812|143187045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.15||0.0009|ONE_SIDED|90.0||-0.03||P-value compared to alpha level adjusted for multiplicity of 0.0125.|t-test, 1 sided|||Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect \>=0.06 LogMAR difference in mean UCDVA between IOL groups.||-0.03||0.0009
71839183|NCT05403827|143187048|SUPERIORITY|||||||0.5019|||||||Control-Based Mean Imputation|||||||0.5019
71794028|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.51||||0|TWO_SIDED|95.0|0.41|0.63|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Good adherence)||0.63|0.41|0.000
71839184|NCT05403827|143187049|SUPERIORITY|||||||0.2028|||||||Control-Based Mean Imputation|||||||0.2028
71839185|NCT05403827|143187050|SUPERIORITY|||||||0.1914|||||||Control-Based Mean Imputation|||||||0.1914
71794029|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|29.4||||0|TWO_SIDED|95.0|11.01|123.8|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Over adherence)||123.80|11.01|0.000
71794030|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|1.31||||0|TWO_SIDED|95.0|0.91|1.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Poor adherence)||1.86|0.91|0.000
71794031|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.05|0.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Good adherence)||0.17|0.05|0.000
71839186|NCT05403827|143187051|SUPERIORITY|||||||0.2512|||||||Control-Based Mean Imputation|||||||0.2512
71673080|NCT00463047|142864187|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|0.08|0.25||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.||0.25|0.08|<0.0001
71794032|NCT03441633|143086054|SUPERIORITY||Odds Ratio (OR)|9.73||||0|TWO_SIDED|95.0|2.81|46.5|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Over adherence)||46.50|2.81|0.000
71839187|NCT05403827|143187052|SUPERIORITY|||||||0.7906|||||||Control-Based Mean Imputation|||||||0.7906
71839188|NCT05403827|143187053|SUPERIORITY|||||||0.5343|||||||Control-Based Mean Imputation|||||||0.5343
71839189|NCT05403827|143187054|SUPERIORITY|||||||0.3757|||||||Control-Based Mean Imputation|||||||0.3757
71839190|NCT05020249|143187171|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71839191|NCT05020249|143187172|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71794033|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|1.08||||0|TWO_SIDED|95.0|0.92|1.27|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.92|0.000
71794034|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|1.45||||0|TWO_SIDED|95.0|1.15|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)||1.83|1.15|0.000
71794035|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|1.09||||0|TWO_SIDED|95.0|0.93|1.27|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)||1.27|0.93|0.000
71794036|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|1.18||||0|TWO_SIDED|95.0|0.96|1.47|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)||1.47|0.96|0.000
71794037|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|0.89||||0|TWO_SIDED|95.0|0.79|1.01|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)||1.01|0.79|0.000
71839192|NCT05020249|143187173|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
71839193|NCT05020249|143187174|SUPERIORITY|||||||0.08||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||0.080
71839194|NCT05020249|143187175|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71839195|NCT05020249|143187176|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71839196|NCT05020249|143187177|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71839197|NCT05020249|143187178|SUPERIORITY||||||<|0.001||||||P-values for the comparison of treatment groups are based on the Fisher's exact test.|Fisher Exact|||||||<0.001
71839198|NCT05020249|143187179|SUPERIORITY||Odds Ratio (OR)|81.25|||<|0.001|TWO_SIDED|95.0|8.216|803.544||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of scalp IGA response for bimekizumab group compared with placebo group using CMH.||803.544|8.216|<0.001
71839199|NCT05020249|143187180|SUPERIORITY||Odds Ratio (OR)|12.353||||0.007|TWO_SIDED|95.0|1.447|105.443||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio of DLQI total score response for bimekizumab group compared with placebo group using CMH.||105.443|1.447|0.007
71839200|NCT05020249|143187181|SUPERIORITY||LS Mean Difference|-80.444|||<|0.001|TWO_SIDED|95.0|-102.509|-58.379|||ANCOVA|||||-58.379|-102.509|<0.001
71839201|NCT03628924|143187195|SUPERIORITY||Treatment difference|12.6|||=|0.166|TWO_SIDED|95.0|-4.6|29.8|||Cochran-Mantel-Haenszel|||||29.8|-4.6|= 0.166
71839202|NCT03628924|143187195|SUPERIORITY||Treatment difference|6.6|||=|0.459|TWO_SIDED|95.0|-10.3|23.6|||Cochran-Mantel-Haenszel|||||23.6|-10.3|= 0.459
71839203|NCT03959696|143187217|SUPERIORITY||Mean Difference (Net)|0.36||||0.011|TWO_SIDED|95.0|0.08|0.64||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure|Mean difference is the Training + Notification arm minus the Notification only arm|The null hypothesis SDMP is equal in the two arms||.64|.08|.011
71839204|NCT03959696|143187218|SUPERIORITY||Mean Difference (Net)|1.77||||0.36|TWO_SIDED|95.0|-2.01|5.55||A priori threshold for statistical significance is .05|Regression, Linear|We used a linear regression model with Generalized Estimating Equations (GEE) techniques to account for the patients-within-physicians data structure||The null hypothesis is that the two arms have the same knowledge score||5.55|-2.01|0.36
71839205|NCT03959696|143187219|SUPERIORITY|We will have 81% power to detect a difference of 14% in rates (e.g. decrease from 61% to 47%).||||||0.47|||||||Regression, Logistic|||We will compare the percentages of patients who received their preferred screening in the 12 months after the visit across the two groups using logistic regression model with the GEE approach to adjust for clustering of patients within clinicians.||||0.47
71839206|NCT03959696|143187220|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
71839207|NCT03959696|143187221|SUPERIORITY||Risk Difference (RD)|9.4||||0.032|TWO_SIDED|95.0|0.9|18.0|||Chi-squared|||Null hypothesis was equal screening rate in both arms||18.0|0.9|0.032
71839208|NCT03959696|143187222|SUPERIORITY||Risk Difference (RD)|1.5||||0.64|TWO_SIDED||||||Chi-squared|||||||0.64
71892918|NCT00733902|143307149|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.8|-0.68|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.68|-1.80|<0.001
71892919|NCT00733902|143307150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.52|-0.13|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.13|-0.52|0.001
71892920|NCT00733902|143307150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.56|-0.17|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.56|<0.001
71892921|NCT00733902|143307150|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.31|||ANCOVA|||ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.31|-0.70|<0.001
71839209|NCT05337306|143187248|SUPERIORITY|ANCOVA controlling for study arm and baseline||||||0.049||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|covariates include arm and baseline level of outcome||Last Observation Carried Forward (LOCF) for those lost to follow up; null hypothesis group 1 follow-up outcome = group 2 follow-up outcome.||||.049
71839210|NCT05337306|143187249|SUPERIORITY|||||||0.04||||||a priori threshold .05; no adjustment for multiple comparisons|ANCOVA|Covariates include trial arm and baseline level of outcome.||LOCF for lost to follow-up||||.040
71839211|NCT05337306|143187250|SUPERIORITY|||||||0.22|||||||ANCOVA|covariates include trial arm and baseline level of outcome.||LOCF for dropout/lost to follow up||||.220
71839212|NCT06019559|143187306|SUPERIORITY|||||||0.0756||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|MMRM model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||||||0.0756
71839213|NCT06019559|143187306|SUPERIORITY|||||||0.0008||||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|(MMRM) model with gender, treatment, visit and treatment-by-visit interaction as fixed effect, and baseline body weight as a covariate.||For the primary endpoint of percentage change from baseline in body weight, a sample size of 150 participants (stratified by gender and randomized 1:1:1 into three treatment arms) provided \>95% power to detect a treatment difference of 4% weight reduction after 13 weeks of treatment with a 2-sided alpha of 0.05, assuming a standard deviation of 4% and 20% drop out.||||0.0008
71839214|NCT06019559|143187307|SUPERIORITY|||||||0.8366||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.8366
71839215|NCT06019559|143187307|SUPERIORITY|||||||0.1848||||||The threshold for significance was p = 0.05.|Regression, Logistic|||||||0.1848
71839216|NCT06019559|143187308|SUPERIORITY|||||||0.0616||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0616
71839217|NCT06019559|143187308|SUPERIORITY|||||||0.0004||||||The threshold for significance was p = 0.05.|Mixed Models Analysis|||||||0.0004
71839218|NCT01814813|143187337|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
71839219|NCT01814813|143187338|SUPERIORITY||||||<|0.01|||||||Log Rank|||||||<0.01
71839220|NCT01814813|143187339|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
71839221|NCT03858634|143187340|SUPERIORITY||Least squares (LS) mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.31||0.398|TWO_SIDED|80.0|-8.68|2.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||2.17|-8.68|0.3980
71839222|NCT03858634|143187340|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.23||0.6653|TWO_SIDED|80.0|-2.17|1.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||1.09|-2.17|0.6653
71839223|NCT03858634|143187340|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.14||0.0711|TWO_SIDED|80.0|-11.63|-3.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-3.56|-11.63|0.0711
71839224|NCT03858634|143187340|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|1.2||0.0186|TWO_SIDED|80.0|-4.7|-1.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-1.51|-4.70|0.0186
71839225|NCT03858634|143187342|SUPERIORITY||LS mean difference|-7.3|STANDARD_ERROR_OF_MEAN|14.76||0.6533|TWO_SIDED|80.0|-31.52|16.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||16.84|-31.52|0.6533
71794038|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|4.82||||0|TWO_SIDED|95.0|3.14|7.55|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)||7.55|3.14|0.000
71892922|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
71794039|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|1.41||||0|TWO_SIDED|95.0|1.19|1.67|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Discontinuation first year)||1.67|1.19|0.000
71794040|NCT03441633|143086055|SUPERIORITY||Odds Ratio (OR)|2.92||||0|TWO_SIDED|95.0|2.12|4.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)||4.05|2.12|0.000
71794041|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|3.63||||0|TWO_SIDED|95.0|3.02|4.24|||ANOVA|||Dabigatran vs. Apixaban in naive participants (NDDDs)||4.24|3.02|0.000
71794042|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|0.11||||0|TWO_SIDED|95.0|-0.77|0.98|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (NDDDs)||0.98|-0.77|0.000
71892923|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
71892924|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
71673081|NCT00463047|142864194|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|0.39|0.58|||ANOVA|||||0.58|0.39|<0.0001
71794043|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|1.51||||0|TWO_SIDED|95.0|0.84|2.17|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (NDDDs)||2.17|0.84|0.000
71794044|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|1.98||||0|TWO_SIDED|95.0|1.16|2.8|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)||2.80|1.16|0.000
71794045|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|0.9||||0|TWO_SIDED|95.0|0.41|1.39|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (NDDDs)||1.39|0.41|0.000
71794046|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0|TWO_SIDED|95.0|-4.32|-0.18|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (NDDDs)||-0.18|-4.32|0.000
71794047|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|28.52||||0|TWO_SIDED|95.0|27.56|29.48|||ANOVA|||Warfarin vs. Apixaban in naive participants (NDDDs)||29.48|27.56|0.000
71794048|NCT03441633|143086056|SUPERIORITY||Mean Difference (Final Values)|1.93||||0|TWO_SIDED|95.0|-1.05|4.9|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (NDDDs)||4.90|-1.05|0.000
71794049|NCT02738333|143086059|NON_INFERIORITY|A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.3|7.1|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|||7.1|-5.3|
71794050|NCT00791518|143086085|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||||95.0|0.1|0.4|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and are adjusted for Investigator.|||0.4|0.1|
71794051|NCT00791518|143086086|SUPERIORITY_OR_OTHER||Least squares mean difference|0.3||||||95.0|0.2|0.4|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||0.4|0.2|
71794052|NCT00791518|143086091|SUPERIORITY_OR_OTHER||Least squares mean difference|0.7||||||95.0|-0.4|1.7|||||Least squares mean differences are calculated as \<80% group minus \>=80% group and was adjusted for Investigator.|||1.7|-0.4|
71794053|NCT00791518|143086092|SUPERIORITY_OR_OTHER||Least squares mean difference|0.9||||||95.0|-0.2|2.1|||||Least squares mean differences are calculated as \<50% group minus \>=50% group and was adjusted for Investigator.|||2.1|-0.2|
71794054|NCT02009046|143086111|SUPERIORITY||Odds Ratio (OR)|1.09||||0.643|TWO_SIDED|95.0|0.75|1.6|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.60|0.75|0.6430
71794055|NCT02009046|143086111|SUPERIORITY||Odds Ratio (OR)|0.75||||0.3718|TWO_SIDED|95.0|0.39|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.39|0.3718
71794056|NCT02009046|143086112|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8083|TWO_SIDED|95.0|0.67|1.37|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.37|0.67|0.8083
71794057|NCT02009046|143086112|SUPERIORITY||Odds Ratio (OR)|0.6||||0.1083|TWO_SIDED|95.0|0.32|1.13|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.13|0.32|0.1083
71794058|NCT02009046|143086113|SUPERIORITY||Odds Ratio (OR)|0.62||||0.1006|TWO_SIDED|95.0|0.35|1.1|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.10|0.35|0.1006
71794059|NCT02009046|143086113|SUPERIORITY||Odds Ratio (OR)|0.49||||0.2117|TWO_SIDED|95.0|0.16|1.53|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.53|0.16|0.2117
71794060|NCT02009046|143086114|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0218|TWO_SIDED|95.0|1.05|1.78|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.78|1.05|0.0218
71794061|NCT02009046|143086114|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0211|TWO_SIDED|95.0|1.09|2.75|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.75|1.09|0.0211
71892925|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.47|-0.4|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.40|-1.47|<0.001
71794062|NCT02009046|143086115|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1763|TWO_SIDED|95.0|0.9|1.73|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.73|0.90|0.1763
71892926|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.013|TWO_SIDED|95.0|-1.22|-0.15|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-1.22|0.013
71892927|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.57|-0.49|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-1.57|<0.001
71794063|NCT02009046|143086115|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5869|TWO_SIDED|95.0|0.45|1.58|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.58|0.45|0.5869
71794064|NCT02009046|143086116|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8102|TWO_SIDED|95.0|0.75|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.44|0.75|0.8102
71794065|NCT02009046|143086116|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2956|TWO_SIDED|95.0|0.39|1.34|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.34|0.39|0.2956
71794066|NCT02009046|143086117|SUPERIORITY||Odds Ratio (OR)|1.13||||0.4645|TWO_SIDED|95.0|0.82|1.56|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.56|0.82|0.4645
71794067|NCT02009046|143086117|SUPERIORITY||Odds Ratio (OR)|0.77||||0.3809|TWO_SIDED|95.0|0.43|1.4|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.40|0.43|0.3809
71794068|NCT02009046|143086118|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1335|TWO_SIDED|95.0|0.52|1.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.09|0.52|0.1335
71794069|NCT02009046|143086118|SUPERIORITY||Odds Ratio (OR)|0.56||||0.0741|TWO_SIDED|95.0|0.29|1.06|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.06|0.29|0.0741
71794070|NCT02009046|143086119|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9085|TWO_SIDED|95.0|0.54|2.01|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.01|0.54|0.9085
71794071|NCT02009046|143086119|SUPERIORITY||Odds Ratio (OR)|1.15||||0.8059|TWO_SIDED|95.0|0.36|3.62|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||3.62|0.36|0.8059
71794072|NCT02009046|143086120|SUPERIORITY||Odds Ratio (OR)|0.87||||0.6861|TWO_SIDED|95.0|0.44|1.71|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||1.71|0.44|0.6861
71794073|NCT02009046|143086120|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9973|TWO_SIDED||||||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|No results provided, as model would not converge.|||||0.9973
71794074|NCT02009046|143086121|SUPERIORITY||Odds Ratio (OR)|1.97||||0.0002|TWO_SIDED|95.0|1.39|2.8|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||2.80|1.39|0.0002
71794075|NCT02009046|143086121|SUPERIORITY||Odds Ratio (OR)|2.71||||0.003|TWO_SIDED|95.0|1.44|5.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.||||5.09|1.44|0.0030
71794076|NCT02073279|143086128|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.0184|TWO_SIDED|95.0|0.23|0.89|||Log Rank|||Stratified by prior therapy (B-cell depleting therapy or immunosuppressants/others) and most recent attack (first attack or relapse).||0.89|0.23|0.0184
71794077|NCT02073279|143086129|SUPERIORITY||Mean Difference (Final Values)|3.215|STANDARD_ERROR_OF_MEAN|4.178||0.4436||95.0|-5.086|11.515|||ANCOVA|ANCOVA model: treatment group as fixed effect and baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||11.515|-5.086|0.4436
71794078|NCT02073279|143086130|SUPERIORITY||Mean Difference (Final Values)|2.107|STANDARD_ERROR_OF_MEAN|1.567||0.1824||95.0|-1.008|5.221|||ANCOVA|ANCOVA model included treatment group as fixed effect. Baseline measurements, prior therapy, most recent attack (first attack/relapse) as covariates.||||5.221|-1.008|0.1824
71794079|NCT00973479|143086161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71794080|NCT00973479|143086162|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71794081|NCT00973479|143086163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
71794082|NCT00973479|143086164|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71794083|NCT00973479|143086165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA of van der Waerden scores|||||||<0.001
71813329|NCT01181726|143129086|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.19|||||TWO_SIDED|90.0|94.71|103.87|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||103.87|94.71|
71839226|NCT03858634|143187342|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|10.51||0.9077|TWO_SIDED|80.0|-15.16|12.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||12.69|-15.16|0.9077
71794084|NCT00335972|143086166|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).|Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-13.0|-5.0||Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.|repeated measures ANOVA||mean difference: Dexmedetomidine arm - Remifentanil arm|||-5|-13|<0.001
71794085|NCT00335972|143086166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|97.5|-13.0|-4.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-4|-13|<0.001
71794086|NCT00335972|143086167|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group|Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.7|-1.1||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).|repeated measures ANOVA model||mean difference: Dexmedetomidine arm - Remifentanil arm|||-1.1|-2.7|<0.001
71794087|NCT00335972|143086167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|||<|0.001|TWO_SIDED|97.5|-2.8|-0.9||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test||-0.9|-2.8|<0.001
71794088|NCT00335972|143086168|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean|Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)|Wilcoxon (Mann-Whitney)||mean difference: Dexmedetomidine arm - Remifentanil|||-5|-10|<0.001
71794089|NCT00335972|143086168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-10.0|-3.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority||-3|-10|<0.001
71794090|NCT02039674|143086197|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|26.3||||0.0016|TWO_SIDED|95.0|8.9|42.1|||Miettinen & Nurminen Method|||||42.1|8.9|0.0016
71794091|NCT02039674|143086198|SUPERIORITY|||||||0.0858|||||||Exact binomial distribution for testing|HO: ORR ≤20% versus H1: ORR \>20%||||||0.0858
71794092|NCT02039674|143086200|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.00252|TWO_SIDED|95.0|0.35|0.83|||Log Rank|One-sided p-value based on log-rank test||||0.83|0.35|0.00252
71794093|NCT02039674|143086201|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.06762|TWO_SIDED|95.0|0.45|1.12|||Log Rank|One-sided p-value based on log-rank test||||1.12|0.45|0.06762
71839227|NCT03858634|143187342|SUPERIORITY||LS mean difference|-61.2|STANDARD_ERROR_OF_MEAN|33.18||0.2065|TWO_SIDED|80.0|-123.73|1.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1.39|-123.73|0.2065
71839228|NCT03858634|143187342|SUPERIORITY||LS mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.19||0.1133|TWO_SIDED|80.0|-9.56|-1.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-1.07|-9.56|0.1133
71839229|NCT03858634|143187342|SUPERIORITY||LS mean difference|-16.7|STANDARD_ERROR_OF_MEAN|21.76||0.4997|TWO_SIDED|80.0|-52.29|18.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||18.98|-52.29|0.4997
71839230|NCT03858634|143187342|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|11.85||0.9919|TWO_SIDED|80.0|-15.83|15.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||15.59|-15.83|0.9919
71839231|NCT03858634|143187342|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|28.56||0.0891|TWO_SIDED|80.0|-143.03|-35.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-35.31|-143.03|0.0891
71794094|NCT01358357|143086203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.078|TWO_SIDED|95.0|0.49|1.04||A hazard ratio of time to recurrence and its corresponding 95% Wald CI were estimated for the lurasidone arm vs.placebo arm, using a Cox proportional hazards model.Cox model included treatment effect as fixed effect, and stratified by pooled country.|Cox Proportional Hazards Model|||It was assumed that the recurrence event rates during the double-blind phase were to be 24% and 39% for subjects treated with lurasidone and placebo, respectively. A total of 120 recurrence events were required to achieve 90% power to detect the 15% difference in subjects who had a recurrence event during the double-blind phase between the treatment groups using a log-rank test with two sided alpha level of 0.05.||1.04|0.49|<0.078
71794095|NCT01358357|143086204|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72|||<|0.034|TWO_SIDED|95.0|0.54|0.98||A HR of time to discontinuation and corresponding 95% Wald CI were est. for lurasidone arm vs.the placebo arm, using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect,stratified by pooled country.|Cox Proportional Hazards Model|||||0.98|0.54|<0.034
71794096|NCT01358357|143086205|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.72||||0.113|TWO_SIDED|95.0|0.48|1.08||A HR of time to recurrence and its corresponding 95% Wald CI were estimated for lurasidone arm vs. placebo arm,using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect stratified by pooled country.|Cox Proportional hazard Model|||||1.08|0.48|0.113
71794097|NCT01358357|143086207|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.09||||0.406|TWO_SIDED|95.0|-0.29|0.12||analysis of ANCOVA model contains treatment ,pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.12|-0.29|0.406
71794098|NCT01358357|143086208|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.11||||0.162|TWO_SIDED|95.0|-0.26|0.04||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.04|-0.26|0.162
71794099|NCT01358357|143086209|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.07||||0.496|TWO_SIDED|95.0|-0.27|0.13||Analysis of covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.13|-0.27|0.496
71794100|NCT01358357|143086210|SUPERIORITY_OR_OTHER||LS mean difference|-0.8||||0.128|TWO_SIDED|95.0|-1.8|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pool country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-1.8|0.128
71794101|NCT01358357|143086211|SUPERIORITY_OR_OTHER||LS mean difference lurasdione vs.Placebo|-0.5||||0.485|TWO_SIDED|95.0|-1.9|0.9||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.9|-1.9|0.485
71794102|NCT01358357|143086212|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.582|TWO_SIDED|95.0|-0.8|0.5||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.5|-0.8|0.582
71794103|NCT01358357|143086213|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.01||||0.42|TWO_SIDED|95.0|-0.5|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.2|-0.5|0.420
71794104|NCT01358357|143086214|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.2||||0.788|TWO_SIDED|95.0|-1.6|1.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||1.2|-1.6|0.788
71794105|NCT01358357|143086215|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||0.1|-0.3|0.380
71794106|NCT01358357|143086216|SUPERIORITY_OR_OTHER||LS mean difference lurasidone vs.Placebo|0.37||||0.772|TWO_SIDED|95.0|-2.14|2.88||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA|||||2.88|-2.14|0.772
71794107|NCT02136576|143086217|SUPERIORITY|||||||0.72||||||"This p-value is for the Air Schiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||0.72
71794108|NCT02136576|143086217|SUPERIORITY|||||||0.93||||||"This p-value is for the Air VAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
71794109|NCT02136576|143086217|SUPERIORITY|||||||0.77||||||"This p-value is for the WaterSchiff comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.77
71794110|NCT02136576|143086217|SUPERIORITY|||||||0.93||||||"This p-value is for the WaterVAS comparison.~The threshold of significance was 0.05 and no multiple comparisons were necessary."|Kruskal-Wallis|||Assuming the control group may exhibit a modest improvement in dentinal hypersensitivity (\~5%) whereas the two test groups should demonstrate a more significant improvement (\~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a 20% dropout rate.||||.93
71794111|NCT00537381|143086218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.728||||0.014|TWO_SIDED|95.0|1.112|2.686|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.686|1.112|0.014
71839232|NCT03858634|143187342|SUPERIORITY||LS mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.1029|TWO_SIDED|80.0|-16.67|-2.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-2.12|-16.67|0.1029
71839233|NCT03858634|143187342|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|32.93||0.5538|TWO_SIDED|80.0|-75.82|32.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.05|-75.82|0.5538
71673082|NCT00463047|142864195|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|0.7|1.16|||ANOVA|||||1.16|0.70|<0.0001
71794112|NCT00537381|143086219|SUPERIORITY_OR_OTHER|||||||0.795|||||||Fisher Exact|||||||0.795
71794113|NCT00537381|143086220|SUPERIORITY_OR_OTHER|||||||0.018|||||||Fisher Exact|||||||0.018
71794114|NCT00537381|143086221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.476||||0.163|TWO_SIDED|95.0|0.853|2.522|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.|||2.522|0.853|0.163
71794115|NCT04365556|143086255|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance is p\<.05|ANCOVA|||||||<0.001
71794116|NCT04365556|143086256|SUPERIORITY|||||||0.69|||||||ANCOVA|||||||0.69
71794117|NCT00567892|143086261|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-6.0|4.0||All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|Wilcoxon signed rank test|Since the assumptions of parametric tests were not met we used non-parametric tests for the analysis.||The null hypothesis for this study was the difference between the change in THI score due to active rTMS treatment and the change in THI score due to rTMS sham was not different from 0.||4|-6|0.944
71794118|NCT00567892|143086261|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0||||0.674|TWO_SIDED|95.0|-9.0|10.0|||Wilcoxon signed rank test|The assumptions of parametric tests were not met.|All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|The null hypothesis for this study was the difference between the change in THI score due to 4 weeks active rTMS treatment and the change in THI score due to 4 weeks rTMS sham was not different from 0.||10|-9|0.674
71794119|NCT01698463|143086271|OTHER||||||<|0.05||||||\<0.05 (threshold for significance).|Wilcoxon (Mann-Whitney)|||||||<0.05
71794120|NCT04709575|143086272|SUPERIORITY||linear mixed-effect model|-0.995||||0.0497|TWO_SIDED|95.0|-1.9886|-0.0011|||LS Mean Difference|||||-0.0011|-1.9886|0.0497
71673083|NCT00463047|142864196|SUPERIORITY_OR_OTHER|||||||0.1966||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.1966
71673084|NCT00463047|142864197|SUPERIORITY_OR_OTHER|||||||0.0275||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0275
71794121|NCT03090100|143086315|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|14.2|||<|0.001|TWO_SIDED|95.0|9.2|19.2|||z-test|||||19.2|9.2|<0.001
71794122|NCT03090100|143086315|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71794123|NCT03090100|143086316|NON_INFERIORITY|Non-inferiority margin of 10%|Difference in percentage|4.3|||<|0.001|TWO_SIDED|95.0|-0.2|8.9|||z-test|||||8.9|-0.2|<0.001
71794124|NCT03090100|143086316|SUPERIORITY|||||||0.062|||||||Cochran-Mantel-Haenszel|||||||0.062
71794125|NCT03090100|143086317|OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-12.2|-1.7||||||||-1.7|-12.2|
71794126|NCT03090100|143086318|OTHER||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-6.0|1.2||||||||1.2|-6.0|
71794127|NCT03090100|143086319|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|3.8|15.5||||||||15.5|3.8|
71794128|NCT03090100|143086320|OTHER||Difference in percentage|11.6|||||TWO_SIDED|95.0|5.8|17.4||||||||17.4|5.8|
71794129|NCT03090100|143086321|OTHER||Difference in percentage|9.7|||||TWO_SIDED|95.0|4.9|14.5||||||||14.5|4.9|
71794130|NCT03090100|143086322|OTHER||Difference in percentage|7.8|||||TWO_SIDED|95.0|2.3|13.2||||||||13.2|2.3|
71794131|NCT03090100|143086323|OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-3.5|3.1||||||||3.1|-3.5|
71794132|NCT03090100|143086324|OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-6.2|3.4||||||||3.4|-6.2|
71794133|NCT03090100|143086325|OTHER||Difference in percentage|9.8|||||TWO_SIDED|95.0|4.2|15.3||||||||15.3|4.2|
71794134|NCT03090100|143086326|OTHER||Difference in percentage|-0.1|||||TWO_SIDED|95.0|-4.2|3.9||||||||3.9|-4.2|
71839234|NCT03858634|143187342|SUPERIORITY||LS mean difference|-11.9|STANDARD_ERROR_OF_MEAN|11.78||0.3252|TWO_SIDED|80.0|-27.51|3.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||3.73|-27.51|0.3252
71839235|NCT03858634|143187342|SUPERIORITY||LS mean difference|-93.8|STANDARD_ERROR_OF_MEAN|34.1||0.1106|TWO_SIDED|80.0|-158.11|-29.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-29.52|-158.11|0.1106
71794135|NCT03090100|143086327|OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-5.0|3.3||||||||3.3|-5.0|
71794136|NCT00952341|143086338|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.007
71794137|NCT00952341|143086339|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.942
71794138|NCT00952341|143086340|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."||||0.001
71794139|NCT00952341|143086341|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy."||||0.003
71794140|NCT00952341|143086342|SUPERIORITY_OR_OTHER|||||||0.882||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.882
71794141|NCT00952341|143086343|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.||||0.001
71794142|NCT05352815|143086353|SUPERIORITY|Change in HbA1c from baseline to week 52 is analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Missing HbA1c values at week 52 are imputed by using multiple imputation. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.|Treatment difference|-0.66|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.57|||ANCOVA|||||-0.57|-0.76|<0.0001
71794143|NCT02759120|143086363|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.83|TWO_SIDED|95.0|0.71|1.53|||Regression, Cox|||||1.53|0.71|0.83
71794144|NCT02759120|143086364|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Regression, Cox|||||1.78|0.70|0.65
71794145|NCT02759120|143086365|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Cox|||||2.17|0.82|0.25
71794146|NCT02759120|143086366|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.13|TWO_SIDED|95.0|0.91|2.01|||Regression, Cox|||||2.01|0.91|0.13
71794147|NCT02759120|143086367|SUPERIORITY||Risk Ratio (RR)|1.21||||0.4|TWO_SIDED|95.0|0.78|1.89|||Regression, Cox|||||1.89|0.78|0.40
71794148|NCT02759120|143086368|SUPERIORITY||Risk Ratio (RR)|1.29||||0.16|TWO_SIDED|95.0|0.9|1.83|||Regression, Cox|||||1.83|0.90|0.16
71794149|NCT02759120|143086369|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.19|TWO_SIDED|95.0|-0.56|2.83|||Regression, Cox|||||2.83|-0.56|0.19
71794150|NCT02759120|143086370|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.51|TWO_SIDED|95.0|-1.67|3.35|||Regression, Cox|||||3.35|-1.67|0.51
71839236|NCT03858634|143187342|SUPERIORITY||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|7.17||0.0123|TWO_SIDED|80.0|-29.48|-10.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-10.40|-29.48|0.0123
71839237|NCT03858634|143187342|SUPERIORITY||LS mean difference|-28.9|STANDARD_ERROR_OF_MEAN|35.86||0.4791|TWO_SIDED|80.0|-87.63|29.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.81|-87.63|0.4791
71892928|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.27||0.003|TWO_SIDED|95.0|-1.36|-0.28|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-1.36|0.003
71892929|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.29|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.29|0.006
71794151|NCT02759120|143086371|SUPERIORITY||Risk Ratio (RR)|0.71||||0.13|TWO_SIDED|95.0|0.46|1.11|||Regression, Cox|||||1.11|0.46|0.13
71794152|NCT02759120|143086372|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
71892930|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.87|-0.79|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.87|<0.001
71794153|NCT02759120|143086373|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.54|TWO_SIDED|95.0|-0.24|0.46|||Regression, Cox|||||0.46|-0.24|0.54
71839238|NCT03858634|143187342|SUPERIORITY||LS mean difference|-5.5|STANDARD_ERROR_OF_MEAN|12.66||0.6684|TWO_SIDED|80.0|-22.28|11.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||11.27|-22.28|0.6684
71839239|NCT03858634|143187342|SUPERIORITY||LS mean difference|-79.7|STANDARD_ERROR_OF_MEAN|26.28||0.0937|TWO_SIDED|80.0|-129.22|-30.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-30.13|-129.22|0.0937
71839240|NCT03858634|143187342|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|9.75||0.012|TWO_SIDED|80.0|-40.21|-14.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-14.27|-40.21|0.0120
71794154|NCT02759120|143086374|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-0.79|0.8|||Regression, Linear|||||0.80|-0.79|0.99
71794155|NCT02759120|143086375|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.76|TWO_SIDED|95.0|-4.64|3.39|||Regression, Cox|||||3.39|-4.64|0.76
71794156|NCT02759120|143086376|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.63|TWO_SIDED|95.0|-0.031|0.051|||Regression, Cox|||||0.051|-0.031|0.63
71794157|NCT02759120|143086377|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.15|TWO_SIDED|95.0|-0.007|0.043|||Regression, Cox|||||0.043|-0.007|0.15
71794158|NCT02759120|143086378|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.53|TWO_SIDED|95.0|-1.11|2.15|||Regression, Cox|||||2.15|-1.11|0.53
71794159|NCT02759120|143086379|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.75|TWO_SIDED|95.0|-1.61|2.2|||Regression, Linear|||||2.20|-1.61|0.75
71794160|NCT04452331|143086390|SUPERIORITY|||||||0.06|||||||Regression, Linear|Adjusted for clinical site||Diastolic BP||||0.06
71794161|NCT04452331|143086390|SUPERIORITY|||||||0.9|||||||Regression, Linear|||Systolic BP||||0.90
71794162|NCT04452331|143086392|SUPERIORITY|||||||0.29|||||||Regression, Linear|||||||.29
71794163|NCT04452331|143086393|SUPERIORITY|||||||0.1|||||||Regression, Logistic|||||||.10
71794164|NCT04452331|143086394|SUPERIORITY|||||||0.44|||||||Regression, Linear|||||||0.44
71794165|NCT04452331|143086395|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||0.01
71794166|NCT04452331|143086396|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||||||0.01
71794167|NCT04452331|143086397|SUPERIORITY|||||||0.54|||||||Regression, negative binomial|||||||0.54
71794168|NCT04452331|143086398|SUPERIORITY|||||||0.74|||||||Regression, negative binomial|||||||0.74
71794169|NCT04452331|143086399|SUPERIORITY|||||||0.03|||||||Regression, Linear|||||||0.03
71794170|NCT04452331|143086399|SUPERIORITY|||||||0.06|||||||Regression, Linear|||||||0.06
71794171|NCT04452331|143086400|SUPERIORITY||||||<|0.001|||||||Regression, negative binomial|||||||<0.001
71794172|NCT04452331|143086400|SUPERIORITY|||||||0.03|||||||Regression, negative binomial|||||||0.03
71794173|NCT04452331|143086401|SUPERIORITY||||||<|0.001|||||||Regression, poisson|||||||<0.001
71794174|NCT04452331|143086401|SUPERIORITY|||||||0.08|||||||Regression, poisson|||||||0.08
71794175|NCT04452331|143086402|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||<.001
71794176|NCT04452331|143086402|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|Mixed effects logistic regression including random effect of visit, to incorporate clustering of prescriptions within visits.||||||0.98
71794177|NCT04452331|143086403|SUPERIORITY|||||||0.2|||||||Regression, Linear|||Systolic BP||||0.20
71794178|NCT04452331|143086403|SUPERIORITY|||||||0.82|||||||Regression, Linear|||Systolic BP||||0.82
71794179|NCT04452331|143086403|SUPERIORITY|||||||0.12|||||||Regression, Linear|||Diastolic BP||||0.12
71839241|NCT03858634|143187342|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|41.95||0.4927|TWO_SIDED|80.0|-101.39|36.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||36.02|-101.39|0.4927
71839242|NCT03858634|143187342|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|13.9||0.4409|TWO_SIDED|80.0|-29.35|7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||7.49|-29.35|0.4409
71839243|NCT03858634|143187342|SUPERIORITY||LS mean difference|-90.7|STANDARD_ERROR_OF_MEAN|34.58||0.1197|TWO_SIDED|80.0|-155.96|-25.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-25.54|-155.96|0.1197
71839244|NCT03858634|143187342|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|12.31||0.0102|TWO_SIDED|80.0|-51.68|-18.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANOVA|||Change at Week 5||-18.92|-51.68|0.0102
71839245|NCT03858634|143187342|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|38.77||0.4515|TWO_SIDED|80.0|-96.97|30.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.02|-96.97|0.4515
71892931|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.68|-0.53|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.53|-1.68|<0.001
71794180|NCT04452331|143086403|SUPERIORITY|||||||0.1|||||||Regression, Linear|||Diastolic BP||||0.10
71794181|NCT03167879|143086448|SUPERIORITY||Odds Ratio (OR)|10.63|||||TWO_SIDED|95.0|2.79|40.49||||||||40.49|2.79|
71794182|NCT03167879|143086449|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.25|2.09||||||||2.09|0.25|
71794183|NCT03167879|143086450|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.02|257.6||||||||257.6|0.02|
71794184|NCT01480076|143086460|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 3: Mixed effect model for repeated measures with visit, baseline PCS score, baseline Expanded Disability Status Scale (EDSS) score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839246|NCT03858634|143187342|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|14.56||0.7623|TWO_SIDED|80.0|-23.76|14.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||14.83|-23.76|0.7623
71839247|NCT03858634|143187342|SUPERIORITY||LS mean difference|-88.5|STANDARD_ERROR_OF_MEAN|34.57||0.1247|TWO_SIDED|80.0|-153.65|-23.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-23.29|-153.65|0.1247
71839248|NCT03858634|143187342|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|11.91||0.0053|TWO_SIDED|80.0|-53.59|-21.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-21.90|-53.59|0.0053
71839249|NCT03858634|143187342|SUPERIORITY||LS mean difference|-17.2|STANDARD_ERROR_OF_MEAN|43.23||0.7177|TWO_SIDED|80.0|-87.97|53.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||53.62|-87.97|0.7177
71892932|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.48|-0.33|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.33|-1.48|0.002
71839250|NCT03858634|143187342|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|14.35||0.6682|TWO_SIDED|80.0|-25.26|12.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||12.78|-25.26|0.6682
71839251|NCT03858634|143187342|SUPERIORITY||LS mean difference|-95.2|STANDARD_ERROR_OF_MEAN|29.16||0.0823|TWO_SIDED|80.0|-150.21|-40.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-40.24|-150.21|0.0823
71794185|NCT01480076|143086460|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794186|NCT01480076|143086460|SUPERIORITY_OR_OTHER||least squares mean|0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0007|TWO_SIDED||||||mixed effect model|||Difference of Month 3 versus Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
71794187|NCT01480076|143086460|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within-group p-value|mixed effect model|||Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794188|NCT01480076|143086460|SUPERIORITY_OR_OTHER||least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2531|TWO_SIDED||||||mixed effect model|||Difference of Month 6 versus Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2531
71839252|NCT03858634|143187342|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|12.95||0.0087|TWO_SIDED|80.0|-55.38|-20.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.92|-55.38|0.0087
71839253|NCT03858634|143187342|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||31.76|-95.11|0.4734
71839254|NCT03858634|143187342|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-23.33|0.8130
71794189|NCT01480076|143086460|SUPERIORITY_OR_OTHER||||||<|0.0001||||||within group p-value|mixed effect model|||Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794190|NCT01480076|143086460|SUPERIORITY_OR_OTHER||least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2299|TWO_SIDED||||||mixed effect model|||Difference of Month 9 versus Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2299
71794191|NCT01480076|143086461|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794192|NCT01480076|143086461|SUPERIORITY_OR_OTHER|||||||0.5405|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5405
71794193|NCT01480076|143086461|SUPERIORITY_OR_OTHER||least squares mean|3.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794194|NCT01480076|143086461|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794195|NCT01480076|143086461|SUPERIORITY_OR_OTHER|||||||0.7272|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7272
71794196|NCT01480076|143086461|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794197|NCT01480076|143086461|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839255|NCT03858634|143187342|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-33.32|-150.60|0.0979
71794198|NCT01480076|143086461|SUPERIORITY_OR_OTHER|||||||0.7484|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7484
71794199|NCT01480076|143086461|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794200|NCT01480076|143086461|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794201|NCT01480076|143086461|SUPERIORITY_OR_OTHER|||||||0.1877|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1877
71794202|NCT01480076|143086461|SUPERIORITY_OR_OTHER||least squares mean|4.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839256|NCT03858634|143187342|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-19.61|-55.48|0.0122
71892933|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.87|-0.72|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.72|-1.87|<0.001
71673085|NCT00463047|142864198|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0001
71794203|NCT01480076|143086461|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794204|NCT01480076|143086461|SUPERIORITY_OR_OTHER|||||||0.546|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5460
71794205|NCT01480076|143086461|SUPERIORITY_OR_OTHER||least squares mean|3.3|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794206|NCT01480076|143086462|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794207|NCT01480076|143086462|SUPERIORITY_OR_OTHER|||||||0.9073|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9073
71794208|NCT01480076|143086462|SUPERIORITY_OR_OTHER||least squares mean|3.0|STANDARD_ERROR_OF_MEAN|0.89||0.0009|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
71794209|NCT01480076|143086462|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794210|NCT01480076|143086462|SUPERIORITY_OR_OTHER|||||||0.5542|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5542
71794211|NCT01480076|143086462|SUPERIORITY_OR_OTHER||least squares mean|4.8|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794212|NCT01480076|143086462|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794213|NCT01480076|143086462|SUPERIORITY_OR_OTHER|||||||0.581|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5810
71794214|NCT01480076|143086462|SUPERIORITY_OR_OTHER||least squares mean|2.7|STANDARD_ERROR_OF_MEAN|1.08||0.014|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0140
71794215|NCT01480076|143086462|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839257|NCT03858634|143187342|SUPERIORITY||LS mean difference|-32.1|STANDARD_ERROR_OF_MEAN|35.35||0.431|TWO_SIDED|80.0|-89.98|25.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||25.81|-89.98|0.4310
71673086|NCT00463047|142864199|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||<0.0001
71673087|NCT00463047|142864200|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0004
71673088|NCT00463047|142864201|SUPERIORITY_OR_OTHER|||||||0.0074||95.0|||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.||||||0.0074
71677272|NCT01516008|142873159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours||||<0.001
71794216|NCT01480076|143086462|SUPERIORITY_OR_OTHER|||||||0.4138|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4138
71794217|NCT01480076|143086462|SUPERIORITY_OR_OTHER||least squares mean|1.3|STANDARD_ERROR_OF_MEAN|1.19||0.274|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
71673089|NCT00463047|142864202|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|0.55|0.83||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||||0.83|0.55|<0.0001
71673090|NCT00463047|142864204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5054||||0.3022|TWO_SIDED|95.0|0.7|3.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||3.3|0.7|0.3022
71794218|NCT01480076|143086462|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794219|NCT01480076|143086462|SUPERIORITY_OR_OTHER|||||||0.6453|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6453
71794220|NCT01480076|143086462|SUPERIORITY_OR_OTHER||least squares mean|3.1|STANDARD_ERROR_OF_MEAN|1.18||0.009|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0090
71794221|NCT01480076|143086463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794222|NCT01480076|143086463|SUPERIORITY_OR_OTHER|||||||0.2475|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2475
71794223|NCT01480076|143086463|SUPERIORITY_OR_OTHER||least squares mean|-8.2|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794224|NCT01480076|143086463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794225|NCT01480076|143086463|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
71839258|NCT03858634|143187342|SUPERIORITY||LS mean difference|-7.1|STANDARD_ERROR_OF_MEAN|15.22||0.6452|TWO_SIDED|80.0|-27.38|13.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||13.12|-27.38|0.6452
71839259|NCT03858634|143187342|SUPERIORITY||LS mean difference|-89.2|STANDARD_ERROR_OF_MEAN|37.02||0.1375|TWO_SIDED|80.0|-159.04|-19.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-19.44|-159.04|0.1375
71839260|NCT03858634|143187342|SUPERIORITY||LS mean difference|-39.6|STANDARD_ERROR_OF_MEAN|14.59||0.0143|TWO_SIDED|80.0|-58.97|-20.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-20.15|-58.97|0.0143
71673091|NCT00463047|142864205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4042||||0.0268|TWO_SIDED|95.0|1.0|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|1.0|0.0268
71839261|NCT03858634|143187342|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|36.4||0.5867|TWO_SIDED|80.0|-81.7|37.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||37.52|-81.70|0.5867
71839262|NCT03858634|143187342|SUPERIORITY||LS mean difference|6.1|STANDARD_ERROR_OF_MEAN|14.38||0.6745|TWO_SIDED|80.0|-12.99|25.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||25.27|-12.99|0.6745
71839263|NCT03858634|143187342|SUPERIORITY||LS mean difference|-85.6|STANDARD_ERROR_OF_MEAN|29.99||0.1039|TWO_SIDED|80.0|-142.18|-29.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-29.09|-142.18|0.1039
71673092|NCT00463047|142864206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4631||||0.0008|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0008
71673093|NCT00463047|142864207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3184||||0.0084|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0084
71673094|NCT00463047|142864208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0788||||0.5283|TWO_SIDED|95.0|0.9|1.4|||Generalize estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.5283
71673095|NCT00463047|142864209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9491||||0.711|TWO_SIDED|95.0|0.7|1.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.3|0.7|0.7110
71794226|NCT01480076|143086463|SUPERIORITY_OR_OTHER||least squares mean|-10.9|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794227|NCT01480076|143086463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839264|NCT03858634|143187342|SUPERIORITY||LS mean difference|-42.5|STANDARD_ERROR_OF_MEAN|15.12||0.0116|TWO_SIDED|80.0|-62.6|-22.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-22.36|-62.60|0.0116
71839265|NCT03858634|143187342|SUPERIORITY||LS mean difference|-23.1|STANDARD_ERROR_OF_MEAN|37.49||0.5807|TWO_SIDED|80.0|-84.55|38.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||38.26|-84.55|0.5807
71673096|NCT00463047|142864210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5355||||0.3288|TWO_SIDED|95.0|0.2|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.9|0.2|0.3288
71673097|NCT00463047|142864211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1485||||0.5145|TWO_SIDED|95.0|0.8|1.7|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.7|0.8|0.5145
71673098|NCT00463047|142864212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4481||||0.0191|TWO_SIDED|95.0|1.1|2.0|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||2.0|1.1|0.0191
71794228|NCT01480076|143086463|SUPERIORITY_OR_OTHER|||||||0.1262|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1262
71839266|NCT03858634|143187342|SUPERIORITY||LS mean difference|8.6|STANDARD_ERROR_OF_MEAN|15.16||0.5765|TWO_SIDED|80.0|-11.55|28.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||28.80|-11.55|0.5765
71839267|NCT03858634|143187342|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|28.36||0.0933|TWO_SIDED|80.0|-139.7|-32.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-32.75|-139.70|0.0933
71839268|NCT03858634|143187342|SUPERIORITY||LS mean difference|-39.3||||0.0173|TWO_SIDED|80.0|-59.29|-19.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-19.37|-59.29|0.0173
71839269|NCT03858634|143187342|SUPERIORITY||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|38.36||0.5293|TWO_SIDED|80.0|-90.04|35.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||35.62|-90.04|0.5293
71839270|NCT03858634|143187342|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|15.12||0.9676|TWO_SIDED|80.0|-20.73|19.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||19.49|-20.73|0.9676
71673099|NCT00463047|142864213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4396||||0.0006|TWO_SIDED|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.8|1.2|0.0006
71677273|NCT01516008|142873159|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||0.001
71673100|NCT00463047|142864214|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3426||||0.0044|TWO_SIDED|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.6|1.1|0.0044
71673101|NCT00463047|142864215|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1448||||0.2184|TWO_SIDED|95.0|0.9|1.4|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.4|0.9|0.2184
71673102|NCT00463047|142864216|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9249||||0.5808|TWO_SIDED|95.0|0.7|1.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.||1.2|0.7|0.5808
71673103|NCT00463047|142864217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8908|||<|0.0001|TWO_SIDED|95.0|1.7|2.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||2.2|1.7|<0.0001
71839271|NCT03858634|143187342|SUPERIORITY||LS mean difference|-86.2|STANDARD_ERROR_OF_MEAN|23.38||0.0663|TWO_SIDED|80.0|-130.27|-42.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-42.11|-130.27|0.0663
71839272|NCT03858634|143187342|SUPERIORITY||LS mean difference|-37.4|STANDARD_ERROR_OF_MEAN|15.33||0.0252|TWO_SIDED|80.0|-57.81|-17.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-17.02|-57.81|0.0252
71839273|NCT03858634|143187342|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|40.81||0.6637|TWO_SIDED|80.0|-86.45|47.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||47.22|-86.45|0.6637
71839274|NCT03858634|143187342|SUPERIORITY||LS mean difference|-1.6|STANDARD_DEVIATION|15.35||0.9173|TWO_SIDED|80.0|-22.04|18.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||18.81|-22.04|0.9173
71892934|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.31||0.027|TWO_SIDED|95.0|-1.28|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.28|0.027
71892935|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.31||0.071|TWO_SIDED|95.0|-1.15|0.05|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.05|-1.15|0.071
71673104|NCT00463047|142864218|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5841|||<|0.0001|TWO_SIDED|95.0|1.4|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.||1.8|1.4|<0.0001
71673105|NCT02560922|142864226|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.128|TWO_SIDED|95.0|-1.45|0.18|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.18|-1.45|0.128
71673106|NCT02560922|142864226|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.068|TWO_SIDED|95.0|-1.73|0.06|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.06|-1.73|0.068
71673107|NCT02560922|142864227|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.129|TWO_SIDED|95.0|-6.01|0.77|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.77|-6.01|0.129
71673108|NCT02560922|142864227|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.084|TWO_SIDED|95.0|-7.07|0.44|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.44|-7.07|0.084
71673109|NCT02560922|142864228|SUPERIORITY||Mean Difference (Final Values)|-1.61||||0.209|TWO_SIDED|95.0|-4.14|0.91|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.91|-4.14|0.209
71839275|NCT03858634|143187342|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|26.55||0.0685|TWO_SIDED|80.0|-146.23|-46.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-46.10|-146.23|0.0685
71839276|NCT03858634|143187342|SUPERIORITY||LS mean difference|-39.7|STANDARD_ERROR_OF_MEAN|15.96||0.023|TWO_SIDED|80.0|-60.91|-18.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-18.44|-60.91|0.0230
71673110|NCT02560922|142864228|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.128|TWO_SIDED|95.0|-5.03|0.63|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.63|-5.03|0.128
71677274|NCT01516008|142873159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours||||<0.001
71839277|NCT03858634|143187342|SUPERIORITY||LS mean difference|-19.1|STANDARD_ERROR_OF_MEAN|37.62||0.6471|TWO_SIDED|80.0|-80.69|42.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||42.54|-80.69|0.6471
71839278|NCT03858634|143187342|SUPERIORITY||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|15.52||0.8044|TWO_SIDED|80.0|-24.56|16.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||16.75|-24.56|0.8044
71839279|NCT03858634|143187342|SUPERIORITY||LS mean difference|-99.5|STANDARD_ERROR_OF_MEAN|28.71||0.0741|TWO_SIDED|80.0|-153.63|-45.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-45.37|-153.63|0.0741
71892936|NCT00733902|143307151|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-1.78|-0.58|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.78|<0.001
71673111|NCT02560922|142864229|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.222|TWO_SIDED|95.0|-2.18|0.51|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.51|-2.18|0.222
71673112|NCT02560922|142864229|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.128|TWO_SIDED|95.0|-2.6|0.33|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.33|-2.60|0.128
71794229|NCT01480076|143086463|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71673113|NCT02560922|142864230|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.111|TWO_SIDED|95.0|-0.4|3.82|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||3.82|-0.40|0.111
71794230|NCT01480076|143086463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794231|NCT01480076|143086463|SUPERIORITY_OR_OTHER|||||||0.8858|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8858
71794232|NCT01480076|143086463|SUPERIORITY_OR_OTHER||least squares mean|-8.6|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794233|NCT01480076|143086463|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794234|NCT01480076|143086463|SUPERIORITY_OR_OTHER|||||||0.2111|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2111
71794235|NCT01480076|143086463|SUPERIORITY_OR_OTHER||least squares mean|-5.8|STANDARD_ERROR_OF_MEAN|2.16||0.0072|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0072
71794236|NCT01480076|143086464|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892937|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.27||0.326|TWO_SIDED|95.0|-0.8|0.27|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.27|-0.80|0.326
71673114|NCT02560922|142864230|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.502|TWO_SIDED|95.0|-1.42|2.88|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||2.88|-1.42|0.502
71673115|NCT02560922|142864231|SUPERIORITY||Mean Difference (Final Values)|0.76||||0.433|TWO_SIDED|95.0|-1.15|2.66|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||2.66|-1.15|0.433
71673116|NCT02560922|142864231|SUPERIORITY||Mean Difference (Final Values)|1.71||||0.12|TWO_SIDED|95.0|-0.45|3.86|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||3.86|-0.45|0.120
71673117|NCT02560922|142864232|SUPERIORITY||Mean Difference (Final Values)|15.31||||0.001|TWO_SIDED|95.0|9.09|21.53|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||21.53|9.09|0.001
71673118|NCT02560922|142864232|SUPERIORITY||Mean Difference (Final Values)|11.67|||<|0.001|TWO_SIDED|95.0|5.08|18.27|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||18.27|5.08|<0.001
71794237|NCT01480076|143086464|SUPERIORITY_OR_OTHER|||||||0.5577|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5577
71794238|NCT01480076|143086464|SUPERIORITY_OR_OTHER||least squares mean|-6.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892938|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.275|TWO_SIDED|95.0|-0.24|0.83|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.83|-0.24|0.275
71794239|NCT01480076|143086464|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794240|NCT01480076|143086464|SUPERIORITY_OR_OTHER|||||||0.9365|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9365
71839280|NCT03858634|143187342|SUPERIORITY||LS mean difference|-39.9|STANDARD_ERROR_OF_MEAN|15.89||0.0219|TWO_SIDED|80.0|-61.0|-18.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-18.72|-61.00|0.0219
71839281|NCT03858634|143187342|SUPERIORITY||LS mean difference|-25.4|STANDARD_ERROR_OF_MEAN|37.15||0.5436|TWO_SIDED|80.0|-86.21|35.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||35.46|-86.21|0.5436
71839282|NCT03858634|143187342|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|16.13||0.9149|TWO_SIDED|80.0|-23.2|19.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||19.71|-23.20|0.9149
71839283|NCT03858634|143187342|SUPERIORITY||LS mean difference|-94.8|STANDARD_ERROR_OF_MEAN|25.34||0.0646|TWO_SIDED|80.0|-142.63|-47.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-47.05|-142.63|0.0646
71839284|NCT03858634|143187342|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.09||0.0611|TWO_SIDED|80.0|-56.89|-11.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-11.41|-56.89|0.0611
71892939|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.27||0.918|TWO_SIDED|95.0|-0.51|0.56|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.56|-0.51|0.918
71892940|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
71673119|NCT02560922|142864233|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.356|TWO_SIDED|95.0|-1.57|0.57|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||0.57|-1.57|0.356
71839285|NCT03858634|143187342|SUPERIORITY||LS mean difference|-22.0|STANDARD_ERROR_OF_MEAN|38.28||0.606|TWO_SIDED|80.0|-84.68|40.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||40.71|-84.68|0.6060
71839286|NCT03858634|143187342|SUPERIORITY||LS mean difference|-6.9|STANDARD_ERROR_OF_MEAN|16.61||0.6823|TWO_SIDED|80.0|-29.0|15.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||15.18|-29.00|0.6823
71673120|NCT02560922|142864233|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.087|TWO_SIDED|95.0|-2.19|0.15|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||0.15|-2.19|0.087
71794241|NCT01480076|143086464|SUPERIORITY_OR_OTHER||least squares mean|-9.4|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839287|NCT03858634|143187342|SUPERIORITY||LS mean difference|-99.7|STANDARD_ERROR_OF_MEAN|24.56||0.0556|TWO_SIDED|80.0|-146.02|-53.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-53.41|-146.02|0.0556
71839288|NCT03858634|143187342|SUPERIORITY||LS mean difference|-33.4|STANDARD_ERROR_OF_MEAN|16.99||0.0652|TWO_SIDED|80.0|-55.98|-10.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.76|-55.98|0.0652
71839289|NCT03858634|143187342|SUPERIORITY||LS mean difference|-26.3|STANDARD_ERROR_OF_MEAN|41.45||0.5714|TWO_SIDED|80.0|-94.14|41.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||41.62|-94.14|0.5714
71839290|NCT03858634|143187342|OTHER||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|16.82||0.5386|TWO_SIDED|80.0|-32.93|11.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||11.83|-32.93|0.5386
71839291|NCT03858634|143187342|SUPERIORITY||LS mean difference|-99.0|STANDARD_ERROR_OF_MEAN|21.41||0.0438|TWO_SIDED|80.0|-139.35|-58.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-58.60|-139.35|0.0438
71839292|NCT03858634|143187342|OTHER||LS mean difference|-27.2|STANDARD_ERROR_OF_MEAN|19.66||0.1829|TWO_SIDED|80.0|-53.38|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-1.08|-53.38|0.1829
71839293|NCT03858634|143187342|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|37.59||0.5443|TWO_SIDED|80.0|-87.2|35.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||35.94|-87.20|0.5443
71892941|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.27||0.052|TWO_SIDED|95.0|-1.06|0.0|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-1.06|0.052
71892942|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.44|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.44|-1.50|<0.001
71673121|NCT02560922|142864234|SUPERIORITY||Mean Difference (Final Values)|1.01|||<|0.001|TWO_SIDED|95.0|0.61|1.41|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months||1.41|0.61|<0.001
71794242|NCT01480076|143086464|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794243|NCT01480076|143086464|SUPERIORITY_OR_OTHER|||||||0.2008|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2008
71794244|NCT01480076|143086464|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|1.98||0.0102|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
71794245|NCT01480076|143086464|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71673122|NCT02560922|142864234|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.002|TWO_SIDED|95.0|0.24|1.09|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months||1.09|0.24|0.002
71794246|NCT01480076|143086464|SUPERIORITY_OR_OTHER|||||||0.7134|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7134
71794247|NCT01480076|143086464|SUPERIORITY_OR_OTHER||least squares mean|-6.0|STANDARD_ERROR_OF_MEAN|2.2||0.0066|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0066
71839294|NCT03858634|143187342|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|18.43||0.6748|TWO_SIDED|80.0|-32.39|16.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.66|-32.39|0.6748
71839295|NCT03858634|143187342|SUPERIORITY||LS mean difference|-96.2|STANDARD_ERROR_OF_MEAN|16.97||0.0297|TWO_SIDED|80.0|-128.19|-64.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.19|-128.19|0.0297
71794248|NCT01480076|143086464|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794249|NCT01480076|143086464|SUPERIORITY_OR_OTHER|||||||0.8202|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8202
71673123|NCT02560922|142864235|SUPERIORITY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.6|-0.95|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 3 months||-0.95|-1.60|<0.001
71673124|NCT02560922|142864235|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 9 months||-0.51|-1.24|<0.001
71673125|NCT02554682|142864236|SUPERIORITY|||||||0.906|||||||Generalized Linear Model|||||||.906
71673126|NCT02554682|142864236|SUPERIORITY|||||||0.796|||||||Generalized Linear Model|||||||.796
71673127|NCT02554682|142864236|SUPERIORITY|||||||0.886|||||||Generalized Linear Model|||||||.886
71673128|NCT02554682|142864236|OTHER|||||||0.082|||||||Generalized Linear Model|||||||.082
71673129|NCT02554682|142864237|SUPERIORITY|||||||0.677|||||||Generalized Linear Model|||||||0.677
71673130|NCT02554682|142864237|SUPERIORITY|||||||0.02|||||||Generalized Linear Model|||||||0.020
71839296|NCT03858634|143187342|SUPERIORITY||LS mean difference|-27.0|STANDARD_ERROR_OF_MEAN|19.8||0.1899|TWO_SIDED|80.0|-53.33|-0.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-0.63|-53.33|0.1899
71839297|NCT03858634|143187344|SUPERIORITY||LS mean difference|-15.3|STANDARD_ERROR_OF_MEAN|24.47||0.5763|TWO_SIDED|80.0|-55.37|24.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||24.78|-55.37|0.5763
71794250|NCT01480076|143086464|SUPERIORITY_OR_OTHER||least squares mean|-6.4|STANDARD_ERROR_OF_MEAN|2.28||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
71794251|NCT01480076|143086465|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794252|NCT01480076|143086465|SUPERIORITY_OR_OTHER|||||||0.1324|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1324
71794253|NCT01480076|143086465|SUPERIORITY_OR_OTHER||least squares mean|-2.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839298|NCT03858634|143187344|SUPERIORITY||LS mean difference|9.6|STANDARD_ERROR_OF_MEAN|14.66||0.5214|TWO_SIDED|80.0|-9.86|29.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||29.01|-9.86|0.5214
71839299|NCT03858634|143187344|SUPERIORITY||LS mean difference|-167.0|STANDARD_ERROR_OF_MEAN|105.28||0.2536|TWO_SIDED|80.0|-365.51|31.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||31.54|-365.51|0.2536
71892943|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.27||0.006|TWO_SIDED|95.0|-1.26|-0.21|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.21|-1.26|0.006
71673131|NCT02554682|142864237|SUPERIORITY|||||||0.952|||||||Generalized Linear Model|||||||.952
71794254|NCT01480076|143086465|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794255|NCT01480076|143086465|SUPERIORITY_OR_OTHER|||||||0.4759|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4759
71839300|NCT03858634|143187344|SUPERIORITY||LS mean difference|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.067|TWO_SIDED|80.0|-18.2|-3.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-3.44|-18.20|0.0670
71673132|NCT02554682|142864237|SUPERIORITY|||||||0.21|||||||Generalized Linear Model|||||||0.210
71673133|NCT02554682|142864238|SUPERIORITY|||||||0.505|||||||Generalized Linear Model|||||||0.505
71673134|NCT02554682|142864238|SUPERIORITY|||||||0.176|||||||Generalized Linear Model|||||||.176
71673135|NCT02554682|142864238|SUPERIORITY|||||||0.134|||||||Generalized Linear Model|||||||0.134
71794256|NCT01480076|143086465|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.59||0.0016|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
71839301|NCT03858634|143187344|SUPERIORITY||LS mean difference|-33.1|STANDARD_ERROR_OF_MEAN|34.98||0.4133|TWO_SIDED|80.0|-90.43|24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||24.15|-90.43|0.4133
71839302|NCT03858634|143187344|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|15.44||0.9305|TWO_SIDED|80.0|-21.83|19.11|||ANCOVA|||Change at Week 2||19.11|-21.83|0.9305
71839303|NCT03858634|143187344|SUPERIORITY||LS mean difference|-160.9|STANDARD_ERROR_OF_MEAN|132.98||0.3499|TWO_SIDED|80.0|-411.65|89.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||89.86|-411.65|0.3499
71839304|NCT03858634|143187344|SUPERIORITY||LS mean difference|-14.0|STANDARD_ERROR_OF_MEAN|9.55||0.1588|TWO_SIDED|80.0|-26.74|-1.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-1.33|-26.74|0.1588
71892944|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
71892945|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.91|-0.86|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.86|-1.91|<0.001
71794257|NCT01480076|143086465|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error||||<0.0001
71794258|NCT01480076|143086465|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2489
71794259|NCT01480076|143086465|SUPERIORITY_OR_OTHER||least squares mean|-2.2|STANDARD_ERROR_OF_MEAN|0.71||0.0017|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0017
71794260|NCT01480076|143086465|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794261|NCT01480076|143086465|SUPERIORITY_OR_OTHER|||||||0.0126|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0126
71794262|NCT01480076|143086465|SUPERIORITY_OR_OTHER||least squares mean|-3.1|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794263|NCT01480076|143086465|SUPERIORITY_OR_OTHER|||||||0.0033|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
71794264|NCT01480076|143086465|SUPERIORITY_OR_OTHER|||||||0.1758|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1758
71794265|NCT01480076|143086465|SUPERIORITY_OR_OTHER||least squares mean|-1.9|STANDARD_ERROR_OF_MEAN|0.84||0.0246|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0246
71794266|NCT01480076|143086466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892946|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.50|<0.001
71794267|NCT01480076|143086466|SUPERIORITY_OR_OTHER|||||||0.0111|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0111
71794268|NCT01480076|143086466|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794269|NCT01480076|143086466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892947|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.27||0.005|TWO_SIDED|95.0|-1.3|-0.23|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.23|-1.30|0.005
71839305|NCT03858634|143187344|SUPERIORITY||LS mean difference|-40.6|STANDARD_ERROR_OF_MEAN|35.19||0.3319|TWO_SIDED|80.0|-98.26|17.0||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.00|-98.26|0.3319
71839306|NCT03858634|143187344|SUPERIORITY||LS mean difference|7.1|STANDARD_ERROR_OF_MEAN|19.39||0.7179|TWO_SIDED|80.0|-18.59|32.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||32.80|-18.59|0.7179
71839307|NCT03858634|143187344|SUPERIORITY||LS mean difference|-193.8|STANDARD_ERROR_OF_MEAN|112.17||0.2261|TWO_SIDED|80.0|-405.34|17.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||17.67|-405.34|0.2261
71839308|NCT03858634|143187344|SUPERIORITY||LS mean difference|-30.3|STANDARD_ERROR_OF_MEAN|10.88||0.0123|TWO_SIDED|80.0|-44.75|-15.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-15.80|-44.75|0.0123
71839309|NCT03858634|143187344|SUPERIORITY||LS mean difference|-54.0|STANDARD_ERROR_OF_MEAN|35.45||0.2253|TWO_SIDED|80.0|-112.02|4.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.09|-112.02|0.2253
71839310|NCT03858634|143187344|SUPERIORITY||LS mean difference|6.3|STANDARD_ERROR_OF_MEAN|16.9||0.7149|TWO_SIDED|80.0|-16.14|28.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||28.66|-16.14|0.7149
71794270|NCT01480076|143086466|SUPERIORITY_OR_OTHER|||||||0.097|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0970
71794271|NCT01480076|143086466|SUPERIORITY_OR_OTHER||least squares mean|11.1|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794272|NCT01480076|143086466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794273|NCT01480076|143086466|SUPERIORITY_OR_OTHER|||||||0.0789|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0789
71673136|NCT02554682|142864238|SUPERIORITY|||||||0.029|||||||Generalized Linear Model|||||||0.029
71839311|NCT03858634|143187344|SUPERIORITY||LS mean difference|-168.4|STANDARD_ERROR_OF_MEAN|109.12||0.2627|TWO_SIDED|80.0|-374.16|37.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||37.36|-374.16|0.2627
71839312|NCT03858634|143187344|SUPERIORITY||LS mean difference|-36.7|STANDARD_ERROR_OF_MEAN|11.38||0.0047|TWO_SIDED|80.0|-51.87|-21.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-21.60|-51.87|0.0047
71673137|NCT02554682|142864239|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||.037
71673138|NCT02554682|142864240|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
71673139|NCT02554682|142864241|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71673140|NCT02554682|142864242|SUPERIORITY|||||||0.571|||||||t-test, 2 sided|||||||.571
71839313|NCT03858634|143187344|SUPERIORITY||LS mean difference|-66.1|STANDARD_ERROR_OF_MEAN|38.01||0.1803|TWO_SIDED|80.0|-128.37|-3.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-3.88|-128.37|0.1803
71839314|NCT03858634|143187344|SUPERIORITY||LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|17.34||0.7174|TWO_SIDED|80.0|-16.62|29.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||29.35|-16.62|0.7174
71839315|NCT03858634|143187344|SUPERIORITY||LS mean difference|-163.4|STANDARD_ERROR_OF_MEAN|103.47||0.2551|TWO_SIDED|80.0|-358.51|31.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.72|-358.51|0.2551
71839316|NCT03858634|143187344|SUPERIORITY||LS mean difference|-33.5|STANDARD_ERROR_OF_MEAN|11.36||0.0086|TWO_SIDED|80.0|-48.58|-18.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-18.36|-48.58|0.0086
71839317|NCT03858634|143187344|SUPERIORITY||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|40.16||0.2576|TWO_SIDED|80.0|-121.78|9.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.78|-121.78|0.2576
71839318|NCT03858634|143187344|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.09||0.9722|TWO_SIDED|80.0|-24.62|23.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||23.34|-24.62|0.9722
71839319|NCT03858634|143187344|SUPERIORITY||LS mean difference|-177.4|STANDARD_ERROR_OF_MEAN|95.72||0.2051|TWO_SIDED|80.0|-357.85|3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||3.13|-357.85|0.2051
71673141|NCT02554682|142864243|SUPERIORITY|||||||0.394|||||||t-test, 2 sided|||||||.394
71673142|NCT02554682|142864244|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||.008
71794274|NCT01480076|143086466|SUPERIORITY_OR_OTHER||least squares mean|9.7|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794275|NCT01480076|143086466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794276|NCT01480076|143086466|SUPERIORITY_OR_OTHER|||||||0.0284|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0284
71794277|NCT01480076|143086466|SUPERIORITY_OR_OTHER||least squares mean|11.2|STANDARD_ERROR_OF_MEAN|2.16|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794278|NCT01480076|143086466|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794279|NCT01480076|143086466|SUPERIORITY_OR_OTHER|||||||0.0108|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0108
71794280|NCT01480076|143086466|SUPERIORITY_OR_OTHER||least squares mean|12.3|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794281|NCT01480076|143086467|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794282|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.8392|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8392
71794283|NCT01480076|143086467|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0162|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0162
71839320|NCT03858634|143187344|SUPERIORITY||LS mean difference|-42.0|STANDARD_ERROR_OF_MEAN|11.99||0.0025|TWO_SIDED|80.0|-57.98|-26.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-26.08|-57.98|0.0025
71839321|NCT03858634|143187344|SUPERIORITY||LS mean difference|-65.8|STANDARD_ERROR_OF_MEAN|33.78||0.1465|TWO_SIDED|80.0|-121.14|-10.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.50|-121.14|0.1465
71673143|NCT02554682|142864245|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71673144|NCT02554682|142864246|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
71673145|NCT02554682|142864247|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||.159
71673146|NCT02554682|142864248|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||.112
71673147|NCT02554682|142864249|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||.165
71673148|NCT02554682|142864250|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
71673149|NCT00953654|142864272|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|The degrees of freedom were adjusted when the sphericity assumption was violated based on Mauchly's test.||Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.||||<0.05
71673150|NCT01537042|142864293|SUPERIORITY_OR_OTHER||Treatment Ratio|0.44||||0.0232|TWO_SIDED|95.0|0.22|0.88|||ANCOVA|An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.||||0.88|0.22|0.0232
71673151|NCT01779440|142864317|SUPERIORITY|||||||0.65||||||The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable.|Chi-squared|||||||0.65
71673152|NCT01408303|142864330|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-2.95|||<|0.05|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.05
71673153|NCT01408303|142864330|SUPERIORITY_OR_OTHER||LS mean difference relative to olive oil|-6.0|||<|0.0001|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.||||||<0.0001
71794284|NCT01480076|143086467|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794285|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.6956|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6956
71794286|NCT01480076|143086467|SUPERIORITY_OR_OTHER||least squares mean|0.06|STANDARD_ERROR_OF_MEAN|0.02||0.0042|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
71794287|NCT01480076|143086467|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794288|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.7949|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7949
71794289|NCT01480076|143086467|SUPERIORITY_OR_OTHER||least squares mean|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0679|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0679
71839322|NCT03858634|143187344|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|17.54||0.7734|TWO_SIDED|80.0|-18.13|28.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.37|-18.13|0.7734
71839323|NCT03858634|143187344|SUPERIORITY||LS mean difference|-175.5|STANDARD_ERROR_OF_MEAN|87.45||0.1826|TWO_SIDED|80.0|-340.37|-10.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-10.56|-340.37|0.1826
71673154|NCT01938092|142864363|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71673155|NCT01938092|142864364|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71673156|NCT01938092|142864365|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71673157|NCT01367886|142864366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53|STANDARD_DEVIATION|4.88||0.19|||||||t-test, 2 sided|||||||0.19
71673158|NCT01367886|142864367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_DEVIATION|0.87||0.0021|||||||t-test, 2 sided|||||||0.0021
71673159|NCT01367886|142864368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|1.02||0.18|||||||t-test, 2 sided|||||||0.18
71673160|NCT01367886|142864369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|STANDARD_DEVIATION|1.34||0.0025|||||||t-test, 2 sided|||||||0.0025
71673161|NCT00985504|142864372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.612|TWO_SIDED|95.0|-1.87|1.1|||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||1.10|-1.87|0.612
71839324|NCT03858634|143187344|SUPERIORITY||LS mean difference|-39.2|STANDARD_ERROR_OF_MEAN|13.71||0.0105|TWO_SIDED|80.0|-57.4|-20.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-20.93|-57.40|0.0105
71839325|NCT03858634|143187344|SUPERIORITY||LS mean difference|-53.7|STANDARD_ERROR_OF_MEAN|40.17||0.2737|TWO_SIDED|80.0|-119.49|12.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.09|-119.49|0.2737
71673162|NCT00985504|142864373|SUPERIORITY_OR_OTHER|||||||0.504||95.0||||This is the p-value for Cognition Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.504
71839326|NCT03858634|143187344|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|17.77||0.8692|TWO_SIDED|80.0|-20.59|26.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||26.52|-20.59|0.8692
71839327|NCT03858634|143187344|SUPERIORITY||LS mean difference|-163.0|STANDARD_ERROR_OF_MEAN|89.64||0.2106|TWO_SIDED|80.0|-332.06|5.99||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||5.99|-332.06|0.2106
71673163|NCT00985504|142864373|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||This is the p-value for the Behavior Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.665
71673164|NCT00985504|142864373|SUPERIORITY_OR_OTHER|||||||0.489||95.0||||This is the p-value for Emotional Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.489
71673165|NCT00985504|142864373|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||This is the p-value for Other Items Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.945
71673166|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.157
71673167|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.119||95.0||||This is the p-value for the Energy Level score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.119
71673168|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||This is the p-value for the Motivation and Interest score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.184
71794290|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
71839328|NCT03858634|143187344|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|14.67||0.006|TWO_SIDED|80.0|-65.19|-26.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-26.14|-65.19|0.0060
71673169|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||This is the p-value for the Cognitive Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.226
71673170|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||This is the p-value for the Weight Gain score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.059
71794291|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.8053|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8053
71839329|NCT03858634|143187344|SUPERIORITY||LS mean difference|-62.3|STANDARD_ERROR_OF_MEAN|36.12||0.1831|TWO_SIDED|80.0|-121.44|-3.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.13|-121.44|0.1831
71673171|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.466||95.0||||This is the p-value for the Sleep score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.466
71673172|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||This is the p-value for the Sexual Functioning score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.822
71673173|NCT00985504|142864374|SUPERIORITY_OR_OTHER|||||||0.599||95.0||||This is the p-value for the Affect score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.599
71673174|NCT00985504|142864375|SUPERIORITY_OR_OTHER|||||||0.723||95.0||||This is the p-value for the PGI-I.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.723
71839330|NCT03858634|143187344|SUPERIORITY||LS mean difference|21.5|STANDARD_ERROR_OF_MEAN|16.39||0.2061|TWO_SIDED|80.0|-0.31|43.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||43.30|-0.31|0.2061
71673175|NCT00985504|142864376|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.410
71673176|NCT00985504|142864377|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||This is the p-value for the Total Score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.880
71673177|NCT00985504|142864377|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||This is the p-value for the Item 8 (Inability to Feel) score.|Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."||||||0.224
71673178|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|95.0||||This is the p-value for the Total Score.|ANCOVA|ANCOVA main effect F test||||||0.910
71673179|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.882||95.0||||This is the p-value for the Motivation/Interest/Enthusiasm Score.|ANCOVA|ANCOVA main effect F test||||||0.882
71673180|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||This is the p-value for the Wakefulness/Alertness Score.|ANCOVA|ANCOVA main effect F test||||||0.657
71673181|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||This is the p-value for the Energy Score.|ANCOVA|ANCOVA main effect F test||||||0.457
71673182|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||This is the p-value for the Ability to Focus/Sustain Attention Score.|ANCOVA|ANCOVA main effect F test||||||0.737
71839331|NCT03858634|143187344|SUPERIORITY||LS mean difference|-161.4|STANDARD_ERROR_OF_MEAN|87.75||0.2073|TWO_SIDED|80.0|-326.83|4.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||4.12|-326.83|0.2073
71839332|NCT03858634|143187344|SUPERIORITY||LS mean difference|-34.4|STANDARD_ERROR_OF_MEAN|15.19||0.0371|TWO_SIDED|80.0|-54.62|-14.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-14.10|-54.62|0.0371
71839333|NCT03858634|143187344|SUPERIORITY||LS mean difference|-55.2|STANDARD_ERROR_OF_MEAN|37.72||0.2393|TWO_SIDED|80.0|-117.01|6.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||6.54|-117.01|0.2393
71839334|NCT03858634|143187344|SUPERIORITY||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|19.01||0.9019|TWO_SIDED|80.0|-22.91|27.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||27.67|-22.91|0.9019
71794292|NCT01480076|143086467|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2638|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2638
71794293|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
71794294|NCT01480076|143086467|SUPERIORITY_OR_OTHER|||||||0.8502|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8502
71794295|NCT01480076|143086467|SUPERIORITY_OR_OTHER||least squares mean|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0917|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0917
71794296|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.1795|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1795
71794297|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.0715|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0715
71794298|NCT01480076|143086468|SUPERIORITY_OR_OTHER||least squares mean|5.8|STANDARD_ERROR_OF_MEAN|4.6||0.2065|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2065
71794299|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.1649|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1649
71794300|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.4894|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4894
71794301|NCT01480076|143086468|SUPERIORITY_OR_OTHER||least squares mean|1.0|STANDARD_ERROR_OF_MEAN|5.89||0.8611|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8611
71794302|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.0073|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0073
71794303|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.1343|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1343
71839335|NCT03858634|143187344|SUPERIORITY||LS mean difference|-149.2|STANDARD_ERROR_OF_MEAN|81.97||0.2103|TWO_SIDED|80.0|-303.77|5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||5.35|-303.77|0.2103
71839336|NCT03858634|143187344|SUPERIORITY||LS mean difference|-22.1|STANDARD_ERROR_OF_MEAN|15.2||0.1634|TWO_SIDED|80.0|-42.4|-1.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-1.88|-42.40|0.1634
71839337|NCT03858634|143187344|SUPERIORITY||LS mean difference|-48.6|STANDARD_ERROR_OF_MEAN|36.28||0.2727|TWO_SIDED|80.0|-108.04|10.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||10.80|-108.04|0.2727
71892948|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.75|-0.69|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.69|-1.75|<0.001
71839338|NCT03858634|143187344|SUPERIORITY||LS mean difference|-9.6|STANDARD_ERROR_OF_MEAN|17.29||0.5839|TWO_SIDED|80.0|-32.65|13.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||13.36|-32.65|0.5839
71839339|NCT03858634|143187344|SUPERIORITY||LS mean difference|-167.8|STANDARD_ERROR_OF_MEAN|76.58||0.1597|TWO_SIDED|80.0|-312.25|-23.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-23.45|-312.25|0.1597
71839340|NCT03858634|143187344|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|16.27||0.1138|TWO_SIDED|80.0|-48.81|-5.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.43|-48.81|0.1138
71839341|NCT03858634|143187344|SUPERIORITY||LS mean difference|-62.0|STANDARD_ERROR_OF_MEAN|24.93||0.0888|TWO_SIDED|80.0|-102.78|-21.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-21.13|-102.78|0.0888
71839342|NCT03858634|143187344|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|18.19||0.9741|TWO_SIDED|80.0|-24.79|23.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||23.60|-24.79|0.9741
71839343|NCT03858634|143187344|SUPERIORITY||LS mean difference|-159.2|STANDARD_ERROR_OF_MEAN|65.42||0.1354|TWO_SIDED|80.0|-282.59|-35.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-35.87|-282.59|0.1354
71839344|NCT03858634|143187344|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|17.21||0.1425|TWO_SIDED|80.0|-49.41|-3.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-3.52|-49.41|0.1425
71839345|NCT03858634|143187344|SUPERIORITY||LS mean difference|-54.6|STANDARD_ERROR_OF_MEAN|26.61||0.1326|TWO_SIDED|80.0|-98.18|-11.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-11.01|-98.18|0.1326
71839346|NCT03858634|143187344|OTHER||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|20.87||0.8433|TWO_SIDED|80.0|-31.95|23.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||23.58|-31.95|0.8433
71673183|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||This is the p-value for the Ability to Remember/Recall Information Score.|ANCOVA|ANCOVA main effect F test||||||0.404
71839347|NCT03858634|143187344|SUPERIORITY||LS mean difference|-130.8|STANDARD_ERROR_OF_MEAN|38.5||0.0768|TWO_SIDED|80.0|-203.39|-58.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-58.19|-203.39|0.0768
71839348|NCT03858634|143187344|SUPERIORITY||LS mean difference|-18.6|STANDARD_ERROR_OF_MEAN|18.69||0.3341|TWO_SIDED|80.0|-43.49|6.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||6.34|-43.49|0.3341
71673184|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.808||95.0||||This is the p-value for the Ability to Find Words Score.|ANCOVA|ANCOVA main effect F test||||||0.808
71839349|NCT03858634|143187346|SUPERIORITY||LS mean difference|-40.9|STANDARD_ERROR_OF_MEAN|40.82||0.4995|TWO_SIDED|80.0|-166.52|84.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||84.74|-166.52|0.4995
71839350|NCT03858634|143187346|SUPERIORITY||LS mean difference|-3.7|STANDARD_ERROR_OF_MEAN|9.59||0.7071|TWO_SIDED|80.0|-16.37|9.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||9.06|-16.37|0.7071
71839351|NCT03858634|143187346|SUPERIORITY||LS mean difference|-52.5|STANDARD_ERROR_OF_MEAN|9.39||0.0305|TWO_SIDED|80.0|-70.18|-34.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||-34.77|-70.18|0.0305
71839352|NCT03858634|143187346|SUPERIORITY||LS mean difference|-6.6|STANDARD_ERROR_OF_MEAN|9.33||0.4884|TWO_SIDED|80.0|-19.01|5.81||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||5.81|-19.01|0.4884
71839353|NCT03858634|143187346|SUPERIORITY||LS mean difference|-45.3|STANDARD_ERROR_OF_MEAN|31.63||0.2885|TWO_SIDED|80.0|-104.93|14.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||14.35|-104.93|0.2885
71839354|NCT03858634|143187346|SUPERIORITY||LS mean difference|5.2|STANDARD_ERROR_OF_MEAN|11.24||0.6505|TWO_SIDED|80.0|-9.73|20.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||20.06|-9.73|0.6505
71839355|NCT03858634|143187346|SUPERIORITY||LS mean difference|-72.1|STANDARD_ERROR_OF_MEAN|5.72||0.0062|TWO_SIDED|80.0|-82.91|-61.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-61.34|-82.91|0.0062
71839356|NCT03858634|143187346|SUPERIORITY||LS mean difference|-19.6|STANDARD_ERROR_OF_MEAN|9.62||0.0571|TWO_SIDED|80.0|-32.34|-6.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.76|-32.34|0.0571
71839357|NCT03858634|143187346|SUPERIORITY||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Change at Week 6||||
71839358|NCT03858634|143187346|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|10.65||0.6927|TWO_SIDED|80.0|-18.38|9.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||9.84|-18.38|0.6927
71892949|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.061|TWO_SIDED|95.0|-1.07|0.02|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.02|-1.07|0.061
71794304|NCT01480076|143086468|SUPERIORITY_OR_OTHER||least squares mean|2.3|STANDARD_ERROR_OF_MEAN|5.09||0.6468|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6468
71794305|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.6441|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6441
71794306|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.2176|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2176
71794307|NCT01480076|143086468|SUPERIORITY_OR_OTHER||least squares mean|8.5|STANDARD_ERROR_OF_MEAN|7.91||0.2814|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2814
71794308|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.7533|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7533
71794309|NCT01480076|143086468|SUPERIORITY_OR_OTHER|||||||0.0653|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0653
71839359|NCT03858634|143187346|SUPERIORITY||LS mean difference|-65.6|STANDARD_ERROR_OF_MEAN|4.08||0.0038|TWO_SIDED|80.0|-73.33|-57.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-57.94|-73.33|0.0038
71839360|NCT03858634|143187346|SUPERIORITY||LS mean difference|-17.4|STANDARD_ERROR_OF_MEAN|9.82||0.094|TWO_SIDED|80.0|-30.43|-4.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-4.30|-30.43|0.0940
71794310|NCT01480076|143086468|SUPERIORITY_OR_OTHER||least squares mean|11.4|STANDARD_ERROR_OF_MEAN|6.65||0.0876|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0876
71673185|NCT00985504|142864378|SUPERIORITY_OR_OTHER|||||||0.431||95.0||||This is the p-value for the Sharpness/Mental Acuity Score.|ANCOVA|ANCOVA main effect F test||||||0.431
71673186|NCT00985504|142864379|SUPERIORITY_OR_OTHER|||||||0.821||95.0||||This is the p-value for the SDS Total Score.|ANCOVA|ANCOVA main effect F test||||||0.821
71673187|NCT00985504|142864379|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||This is the p-value for the Item 1 (Work) Score.|ANCOVA|ANCOVA main effect F test||||||0.491
71673188|NCT00985504|142864379|SUPERIORITY_OR_OTHER|||||||0.451||95.0||||This is the p-value for the Item 2 (Family) Score.|ANCOVA|ANCOVA main effect F test||||||0.451
71794311|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.0281|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0281
71794312|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
71794313|NCT01480076|143086469|SUPERIORITY_OR_OTHER||least squares mean|4.3|STANDARD_ERROR_OF_MEAN|4.47||0.34|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3400
71794314|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0012
71839361|NCT03858634|143187346|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|19.73||0.1694|TWO_SIDED|80.0|-133.1|-11.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-11.65|-133.10|0.1694
71839362|NCT03858634|143187346|SUPERIORITY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|10.07||0.7811|TWO_SIDED|80.0|-10.5|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||16.18|-10.50|0.7811
71794315|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.749|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7490
71794316|NCT01480076|143086469|SUPERIORITY_OR_OTHER||least squares mean|-5.1|STANDARD_ERROR_OF_MEAN|5.53||0.3592|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3592
71794317|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.0015|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0015
71794318|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.2967|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2967
71794319|NCT01480076|143086469|SUPERIORITY_OR_OTHER||least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|5.34||0.8735|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8735
71794320|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.1696|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1696
71794321|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.0089|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0089
71794322|NCT01480076|143086469|SUPERIORITY_OR_OTHER||least squares mean|14.9|STANDARD_ERROR_OF_MEAN|6.83||0.0297|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0297
71794323|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.8806|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8806
71794324|NCT01480076|143086469|SUPERIORITY_OR_OTHER|||||||0.217|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2170
71794325|NCT01480076|143086469|SUPERIORITY_OR_OTHER||least squares mean|8.1|STANDARD_ERROR_OF_MEAN|6.86||0.2392|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2392
71839363|NCT03858634|143187346|SUPERIORITY||LS mean difference|-68.2|STANDARD_ERROR_OF_MEAN|2.28||0.0011|TWO_SIDED|80.0|-72.51|-63.91||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-63.91|-72.51|0.0011
71839364|NCT03858634|143187346|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|9.52||0.0245|TWO_SIDED|80.0|-36.02|-10.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-10.70|-36.02|0.0245
71839365|NCT03858634|143187346|SUPERIORITY||LS mean difference|-61.8|STANDARD_ERROR_OF_MEAN|5.87||0.0603|TWO_SIDED|80.0|-79.88|-43.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-43.74|-79.88|0.0603
71839366|NCT03858634|143187346|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.89||0.4365|TWO_SIDED|80.0|-5.29|21.04||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||21.04|-5.29|0.4365
71673189|NCT00985504|142864379|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||This is the p-value for the Item 3 (Social) Score.|ANCOVA|ANCOVA main effect F test||||||0.443
71673190|NCT00985504|142864379|SUPERIORITY_OR_OTHER|||||||0.719||95.0||||This is the p-value for the Item 4 (Days Lost) Score.|ANCOVA|ANCOVA main effect F test||||||0.719
71673191|NCT00985504|142864379|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||This is the p-value for the Item 5 (Days Underproductive) Score.|ANCOVA|ANCOVA main effect F test||||||0.517
71673192|NCT00985504|142864380|SUPERIORITY_OR_OTHER|||||||0.776||95.0|||||Fisher Exact|||||||0.776
71673193|NCT00985504|142864381|SUPERIORITY_OR_OTHER|||||||0.691||95.0|||||Log Rank|||The log-rank test was conducted using Kaplan-Meier Product-Limit method.||||0.691
71673194|NCT00985504|142864382|SUPERIORITY_OR_OTHER|||||||0.724||95.0|||||Fisher Exact|||||||0.724
71673195|NCT03711786|142864383|SUPERIORITY||Odds Ratio (OR)|1.2||||0.836|TWO_SIDED|95.0|0.22|6.65|||Regression - GEE, logistic|From Wald z-statistic from generalized estimating equations (GEE) model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.65|0.22|0.836
71794326|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
71794327|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.1259|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
71794328|NCT01480076|143086470|SUPERIORITY_OR_OTHER||least squares mean|3.6|STANDARD_ERROR_OF_MEAN|5.68||0.5312|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5312
71794329|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0022
71794330|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.4968|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4968
71794331|NCT01480076|143086470|SUPERIORITY_OR_OTHER||least squares mean|-3.2|STANDARD_ERROR_OF_MEAN|6.64||0.6283|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6283
71794332|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
71673196|NCT03711786|142864384|SUPERIORITY||Odds Ratio (OR)|0.86||||0.877|TWO_SIDED|95.0|0.12|6.14|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||6.14|0.12|0.877
71673197|NCT03711786|142864385|SUPERIORITY||Odds Ratio (OR)|18.36||||0.001|TWO_SIDED|95.0|3.23|104.23|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||104.23|3.23|0.001
71673198|NCT03711786|142864386|SUPERIORITY||Odds Ratio (OR)|2.15||||0.017|TWO_SIDED|95.0|1.15|4.01|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||4.01|1.15|0.017
71673199|NCT03711786|142864387|SUPERIORITY||Odds Ratio (OR)|0.9||||0.759|TWO_SIDED|95.0|0.45|1.8|||Regression - GEE, logistic|From Wald z-statistic from GEE model with bias-corrected standard error|Enhanced arm (index) compared to basic arm (referent). GEE model with bias-corrected standard errors.|||1.80|0.45|0.759
71673200|NCT04031846|142864393|OTHER|Difference in % and 95 % confidence interval (CI) are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.6|||=|0.824|TWO_SIDED|95.0|-5.0|6.3|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in % : Injection site erythema||6.3|-5.0|= 0.824
71673201|NCT04031846|142864393|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|2.8|||=|0.324|TWO_SIDED|95.0|-2.8|8.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site induration||8.4|-2.8|= 0.324
71673202|NCT04031846|142864393|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|11.3|||<|0.001|TWO_SIDED|95.0|5.8|16.6|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site pain||16.6|5.8|< 0.001
71673203|NCT04031846|142864393|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.1|||=|0.128|TWO_SIDED|95.0|-1.2|9.4|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Injection site swelling||9.4|-1.2|= 0.128
71673204|NCT04031846|142864394|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|0.4|||=|0.885|TWO_SIDED|95.0|-5.0|5.8|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Decreased appetite||5.8|-5.0|= 0.885
71673205|NCT04031846|142864394|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|5.4|||=|0.045|TWO_SIDED|95.0|0.1|10.7|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Irritability||10.7|0.1|= 0.045
71794333|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.6631|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6631
71794334|NCT01480076|143086470|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|6.77||0.477|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4770
71794335|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.4027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4027
71794336|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.1077|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1077
71794337|NCT01480076|143086470|SUPERIORITY_OR_OTHER||least squares mean|13.5|STANDARD_ERROR_OF_MEAN|9.98||0.1781|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1781
71794338|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.2422|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2422
71794339|NCT01480076|143086470|SUPERIORITY_OR_OTHER|||||||0.0994|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0994
71794340|NCT01480076|143086470|SUPERIORITY_OR_OTHER||least squares mean|8.8|STANDARD_ERROR_OF_MEAN|7.13||0.2194|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2194
71794341|NCT01480076|143086471|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794342|NCT01480076|143086471|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
71794343|NCT01480076|143086471|SUPERIORITY_OR_OTHER||least squares mean|-7.3|STANDARD_ERROR_OF_MEAN|2.2||0.001|TWO_SIDED||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
71794344|NCT01480076|143086471|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839367|NCT03858634|143187346|SUPERIORITY||LS mean difference|-68.7|STANDARD_ERROR_OF_MEAN|10.3||0.0218|TWO_SIDED|80.0|-88.11|-49.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-49.26|-88.11|0.0218
71839368|NCT03858634|143187346|SUPERIORITY||LS mean difference|-19.5|STANDARD_ERROR_OF_MEAN|12.07||0.1238|TWO_SIDED|80.0|-35.65|-3.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-3.45|-35.65|0.1238
71673206|NCT04031846|142864394|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|4.4|||=|0.131|TWO_SIDED|95.0|-1.3|10.0|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Somnolence||10.0|-1.3|= 0.131
71673207|NCT04031846|142864394|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.1|||=|0.898|TWO_SIDED|95.0|-2.4|2.1|||Miettinen & Nurminen||V114 minus Prevenar 13™|Difference in %: Urticaria||2.1|-2.4|= 0.898
71673208|NCT04031846|142864395|OTHER|Difference in % and 95 % CI are calculated based on the Miettinen \& Nurminen method.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.0|0.5|||||V114 minus Prevenar 13™|Difference in %||0.5|-1.0|
71794345|NCT01480076|143086471|SUPERIORITY_OR_OTHER|||||||0.2777|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2777
71794346|NCT01480076|143086471|SUPERIORITY_OR_OTHER||least squares mean|-10.4|STANDARD_ERROR_OF_MEAN|2.76||0.0002|TWO_SIDED||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
71794347|NCT01480076|143086471|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794348|NCT01480076|143086471|SUPERIORITY_OR_OTHER|||||||0.1078|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1078
71794349|NCT01480076|143086471|SUPERIORITY_OR_OTHER||least squares mean|-7.6|STANDARD_ERROR_OF_MEAN|2.87||0.0082|TWO_SIDED||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0082
71794350|NCT01480076|143086471|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794351|NCT01480076|143086471|SUPERIORITY_OR_OTHER|||||||0.1838|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1838
71794352|NCT01480076|143086471|SUPERIORITY_OR_OTHER||least squares mean|-6.3|STANDARD_ERROR_OF_MEAN|3.02||0.0364|TWO_SIDED||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0364
71794353|NCT01480076|143086471|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794354|NCT01480076|143086471|SUPERIORITY_OR_OTHER|||||||0.1714|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1714
71794355|NCT01480076|143086471|SUPERIORITY_OR_OTHER||least squares mean|-4.8|STANDARD_ERROR_OF_MEAN|3.14||0.1259|TWO_SIDED||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1259
71794356|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71673209|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.62|||<|0.001|TWO_SIDED|95.0|0.57|0.68||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 1 GMC Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.57|< 0.001
71677275|NCT01516008|142873159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
71794357|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794358|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794359|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0004
71794360|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794361|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794362|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794363|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.0069|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0069
71794364|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794365|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794366|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
71794367|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0006
71794368|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794369|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794370|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794371|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
71794372|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794373|NCT01480076|143086472|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794374|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.0047|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0047
71794375|NCT01480076|143086472|SUPERIORITY_OR_OTHER|||||||0.0118|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0118
71794376|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794377|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794378|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794379|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.1398|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1398
71794380|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794381|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794382|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794383|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.0935|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0935
71794384|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794385|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794386|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71892950|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.021|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.20|0.021
71677276|NCT01516008|142873159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours||||<0.001
71794387|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.076|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0760
71794388|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794389|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.0019|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0019
71892951|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.85|-0.76|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.76|-1.85|<0.001
71892952|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.166|TWO_SIDED|95.0|-0.95|0.16|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.166
71673210|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|1.28|||<|0.001|TWO_SIDED|95.0|1.17|1.39||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 3 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.17|< 0.001
71673211|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.82||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 4 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.82|0.68|< 0.001
71673212|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.7||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 5 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.70|0.59|< 0.001
71673213|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.61|0.76||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.76|0.61|< 0.001
71794390|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.0037|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0037
71794391|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.2489|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2489
71673214|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.07||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 6B GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.07|0.85|< 0.001
71673215|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.72|0.85||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 7F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.72|< 0.001
71794392|NCT01480076|143086473|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794393|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
71794394|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.0052|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0052
71794395|NCT01480076|143086473|SUPERIORITY_OR_OTHER|||||||0.7714|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7714
71794396|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794397|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794398|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71839369|NCT03858634|143187346|SUPERIORITY||LS mean difference|-54.8|STANDARD_ERROR_OF_MEAN|23.38||0.1437|TWO_SIDED|80.0|-98.88|-10.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.72|-98.88|0.1437
71839370|NCT03858634|143187346|SUPERIORITY||LS mean difference|0.9|STANDARD_ERROR_OF_MEAN|10.14||0.9279|TWO_SIDED|80.0|-12.56|14.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||14.43|-12.56|0.9279
71839371|NCT03858634|143187346|SUPERIORITY||LS mean difference|-59.5|STANDARD_ERROR_OF_MEAN|9.67||0.0254|TWO_SIDED|80.0|-77.69|-41.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-41.24|-77.69|0.0254
71839372|NCT03858634|143187346|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|10.8||0.0994|TWO_SIDED|80.0|-33.23|-4.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-4.43|-33.23|0.0994
71673216|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.78||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 9V GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.66|< 0.001
71677277|NCT01516008|142873159|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||0.001
71794399|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794400|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794401|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794402|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71839373|NCT03858634|143187346|SUPERIORITY||LS mean difference|-45.7|STANDARD_ERROR_OF_MEAN|39.36||0.3656|TWO_SIDED|80.0|-119.9|28.54||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||28.54|-119.90|0.3656
71839374|NCT03858634|143187346|SUPERIORITY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|8.92||0.7465|TWO_SIDED|80.0|-14.79|8.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||8.94|-14.79|0.7465
71839375|NCT03858634|143187346|SUPERIORITY||LS mean difference|-82.3|STANDARD_ERROR_OF_MEAN|10.3||0.0153|TWO_SIDED|80.0|-101.75|-62.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-62.90|-101.75|0.0153
71839376|NCT03858634|143187346|SUPERIORITY||LS mean difference|-16.6|STANDARD_ERROR_OF_MEAN|12.97||0.2184|TWO_SIDED|80.0|-33.88|0.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||0.72|-33.88|0.2184
71839377|NCT03858634|143187346|SUPERIORITY||LS mean difference|-8.1|STANDARD_ERROR_OF_MEAN|25.78||0.7726|TWO_SIDED|80.0|-50.37|34.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||34.07|-50.37|0.7726
71839378|NCT03858634|143187346|SUPERIORITY||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|12.66||0.476|TWO_SIDED|80.0|-26.07|7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||7.63|-26.07|0.4760
71839379|NCT03858634|143187346|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-64.87|-99.26|0.0121
71839380|NCT03858634|143187346|SUPERIORITY||LS mean difference|-13.0|STANDARD_ERROR_OF_MEAN|13.06||0.3329|TWO_SIDED|80.0|-30.43|4.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||4.40|-30.43|0.3329
71839381|NCT03858634|143187346|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|28.46||0.9564|TWO_SIDED|80.0|-48.31|44.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||44.92|-48.31|0.9564
71839382|NCT03858634|143187346|SUPERIORITY||LS mean difference|-7.9|STANDARD_ERROR_OF_MEAN|13.49||0.5661|TWO_SIDED|80.0|-25.84|10.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||10.06|-25.84|0.5661
71839383|NCT03858634|143187346|SUPERIORITY||LS mean difference|-82.1|STANDARD_ERROR_OF_MEAN|9.12||0.0121|TWO_SIDED|80.0|-99.26|-64.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-64.87|-99.26|0.0121
71673217|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.67|0.83||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 14 GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.67|< 0.001
71673218|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.95||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 18C GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.80|< 0.001
71673219|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19A GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.75|< 0.001
71673220|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.8|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 19F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.80|< 0.001
71673221|NCT04031846|142864396|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.79|0.97||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 23F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.97|0.79|< 0.001
71673222|NCT04031846|142864396|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|71.79|||<|0.001|TWO_SIDED|95.0|65.16|79.1||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 22F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||79.10|65.16|< 0.001
71673223|NCT04031846|142864396|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevenar 13™) being \>2.0 (1-sided p-value \<0.025).|GMC Ratio|46.58|||<|0.001|TWO_SIDED|95.0|42.19|51.42||1-sided p-value|t-distribution||V114/Prevenar 13™|Serotype 33F GMC Ratio: CI and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||51.42|42.19|< 0.001
71673224|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.8|||<|0.001|TWO_SIDED|95.0|-4.7|-1.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI is based on the Miettinen \& Nurminen method.|-1.3|-4.7|< 0.001
71794403|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794404|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71673225|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|8.2|||<|0.001|TWO_SIDED|95.0|4.4|12.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI is based on the Miettinen \& Nurminen method.|12.2|4.4|< 0.001
71673226|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-4.5|< 0.001
71839384|NCT03858634|143187346|SUPERIORITY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|13.7||0.4275|TWO_SIDED|80.0|-29.4|7.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||7.13|-29.40|0.4275
71794405|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71839385|NCT03858634|143187351|SUPERIORITY||LS mean difference|-27.9|STANDARD_ERROR_OF_MEAN|40.54||0.5403|TWO_SIDED|80.0|-94.32|38.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.46|-94.32|0.5403
71794406|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794407|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794408|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794409|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794410|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794411|NCT01480076|143086474|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0009
71794412|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794413|NCT01480076|143086474|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794414|NCT01480076|143086474|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
71794415|NCT01480076|143086474|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
71839386|NCT03858634|143187351|SUPERIORITY||LS mean difference|376.1|STANDARD_ERROR_OF_MEAN|631.83||0.5587|TWO_SIDED|80.0|-462.83|1214.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||1214.97|-462.83|0.5587
71839387|NCT03858634|143187351|SUPERIORITY||LS mean difference|-67.7|STANDARD_ERROR_OF_MEAN|72.99||0.4516|TWO_SIDED|80.0|-205.33|69.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||69.93|-205.33|0.4516
71839388|NCT03858634|143187351|SUPERIORITY||LS mean difference|-12.5|STANDARD_ERROR_OF_MEAN|9.5||0.2052|TWO_SIDED|80.0|-25.13|0.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||0.15|-25.13|0.2052
71794416|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794417|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794418|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71839389|NCT03858634|143187351|SUPERIORITY||LS mean difference|-59.4|STANDARD_ERROR_OF_MEAN|38.89||0.224|TWO_SIDED|80.0|-123.09|4.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||4.28|-123.09|0.2240
71839390|NCT03858634|143187351|SUPERIORITY||LS mean difference|39.5|STANDARD_ERROR_OF_MEAN|48.33||0.4242|TWO_SIDED|80.0|-24.7|103.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||103.65|-24.70|0.4242
71839391|NCT03858634|143187351|SUPERIORITY||LS mean difference|-77.2|STANDARD_ERROR_OF_MEAN|78.61||0.4295|TWO_SIDED|80.0|-225.44|71.01||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||71.01|-225.44|0.4295
71794419|NCT01480076|143086475|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
71794420|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71673227|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
71794421|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794422|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794423|NCT01480076|143086475|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
71794424|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794425|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794426|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71839392|NCT03858634|143187351|SUPERIORITY||LS mean difference|-18.7|STANDARD_ERROR_OF_MEAN|14.97||0.2272|TWO_SIDED|80.0|-38.64|1.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||1.20|-38.64|0.2272
71794427|NCT01480076|143086475|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0097
71794428|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794429|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794430|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794431|NCT01480076|143086475|SUPERIORITY_OR_OTHER|||||||0.0103|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0103
71794432|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71839393|NCT03858634|143187351|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|48.9||0.3416|TWO_SIDED|80.0|-135.23|24.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.95|-135.23|0.3416
71677278|NCT01516008|142873159|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours||||<0.001
71677279|NCT01516008|142873160|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||0.001
71673228|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.9|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI is based on the Miettinen \& Nurminen method.|1.1|-1.9|< 0.001
71794433|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794434|NCT01480076|143086475|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794435|NCT01480076|143086475|SUPERIORITY_OR_OTHER|||||||0.1227|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1227
71794436|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794437|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794438|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.1754|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1754
71794439|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0192|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0192
71794440|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794441|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794442|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
71794443|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0157|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0157
71794444|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794445|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
71794446|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.1012|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1012
71794447|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0749|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0749
71839394|NCT03858634|143187351|SUPERIORITY||LS mean difference|57.6|STANDARD_ERROR_OF_MEAN|69.75||0.4192|TWO_SIDED|80.0|-35.02|150.19||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||150.19|-35.02|0.4192
71677280|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
71677281|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
71673229|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.5|-0.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI is based on the Miettinen \& Nurminen method.|-0.1|-3.5|< 0.001
71794448|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71673230|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.9|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI is based on the Miettinen \& Nurminen method.|0.9|-0.9|< 0.001
71673231|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.4|-0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI is based on the Miettinen \& Nurminen method.|-0.4|-2.4|< 0.001
71673232|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
71673233|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.8|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.8|< 0.001
71673234|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.2|-0.2||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI is based on the Miettinen \& Nurminen method.|-0.2|-2.2|< 0.001
71794449|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0455|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0455
71794450|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.4699|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4699
71794451|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.0235|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0235
71839395|NCT03858634|143187351|SUPERIORITY||LS mean difference|-66.8|STANDARD_ERROR_OF_MEAN|87.42||0.5245|TWO_SIDED|80.0|-231.66|98.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||98.02|-231.66|0.5245
71839396|NCT03858634|143187351|SUPERIORITY||LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|13.31||0.1988|TWO_SIDED|80.0|-35.47|-0.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-0.05|-35.47|0.1988
71673235|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
71673236|NCT04031846|142864397|NON_INFERIORITY|Non-inferiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-2.7|1.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI is based on the Miettinen \& Nurminen method.|1.5|-2.7|< 0.001
71673237|NCT04031846|142864397|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|93.8|||<|0.001|TWO_SIDED|95.0|91.5|95.6||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI is based on the Miettinen \& Nurminen method.|95.6|91.5|< 0.001
71673238|NCT04031846|142864397|SUPERIORITY|Superiority of V114 to Prevenar 13™ is based on the lower bound of the 95% CI for the difference in percentages (V114 - Prevenar 13™) being \>10 percentage points (1-sided p-value \<0.025).|Percentage Difference|94.9|||<|0.001|TWO_SIDED|95.0|92.7|96.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI is based on the Miettinen \& Nurminen method.|96.5|92.7|< 0.001
71677282|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
71677283|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71794452|NCT01480076|143086476|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794453|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.1978|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1978
71794454|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.1977|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1977
71794455|NCT01480076|143086476|SUPERIORITY_OR_OTHER|||||||0.225|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2250
71794456|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794457|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794458|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794459|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.0649|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0649
71794460|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794461|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794462|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794463|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
71794464|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71673239|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-1.7|0.4||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Diphtheria toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.4|-1.7|< 0.001
71794465|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839397|NCT03858634|143187351|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|56.11||0.3054|TWO_SIDED|80.0|-161.08|22.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.72|-161.08|0.3054
71677284|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71839398|NCT03858634|143187351|SUPERIORITY||LS mean difference|229.4|STANDARD_ERROR_OF_MEAN|377.23||0.5504|TWO_SIDED|80.0|-271.51|730.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||730.22|-271.51|0.5504
71839399|NCT03858634|143187351|SUPERIORITY||LS mean difference|-71.2|STANDARD_ERROR_OF_MEAN|76.27||0.4493|TWO_SIDED|80.0|-214.96|72.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||72.65|-214.96|0.4493
71839400|NCT03858634|143187351|SUPERIORITY||LS mean difference|-40.3|STANDARD_ERROR_OF_MEAN|20.63||0.0665|TWO_SIDED|80.0|-67.74|-12.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-12.85|-67.74|0.0665
71839401|NCT03858634|143187351|SUPERIORITY||LS mean difference|-78.7|STANDARD_ERROR_OF_MEAN|54.04||0.2411|TWO_SIDED|80.0|-167.25|9.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||9.75|-167.25|0.2411
71839402|NCT03858634|143187351|SUPERIORITY||LS mean difference|60.8|STANDARD_ERROR_OF_MEAN|79.3||0.4528|TWO_SIDED|80.0|-44.51|166.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||166.08|-44.51|0.4528
71839403|NCT03858634|143187351|SUPERIORITY||LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|75.46||0.6381|TWO_SIDED|80.0|-183.72|100.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||100.85|-183.72|0.6381
71839404|NCT03858634|143187351|SUPERIORITY||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|17.22||0.0837|TWO_SIDED|80.0|-54.44|-8.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.62|-54.44|0.0837
71839405|NCT03858634|143187351|SUPERIORITY||LS mean difference|-74.7|STANDARD_ERROR_OF_MEAN|66.45||0.3428|TWO_SIDED|80.0|-183.53|34.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||34.13|-183.53|0.3428
71839406|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|21.8|STANDARD_ERROR_OF_MEAN|22.93||0.3533|TWO_SIDED|80.0|-8.63|52.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||52.27|-8.63|0.3533
71839407|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-63.9|STANDARD_ERROR_OF_MEAN|56.53||0.3755|TWO_SIDED|80.0|-170.51|42.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||42.66|-170.51|0.3755
71673240|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Tetanus toxoid|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
71839408|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|15.6||0.0268|TWO_SIDED|80.0|-58.39|-16.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.87|-58.39|0.0268
71839409|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-79.5|STANDARD_ERROR_OF_MEAN|43.79||0.1672|TWO_SIDED|80.0|-151.2|-7.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-7.75|-151.20|0.1672
71839410|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|43.7|STANDARD_ERROR_OF_MEAN|45.81||0.3518|TWO_SIDED|80.0|-17.09|104.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.55|-17.09|0.3518
71839411|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-68.7|STANDARD_ERROR_OF_MEAN|49.22||0.2974|TWO_SIDED|80.0|-161.52|24.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||24.09|-161.52|0.2974
71839412|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|18.6||0.0555|TWO_SIDED|80.0|-62.83|-13.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.33|-62.83|0.0555
71839413|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-78.3|STANDARD_ERROR_OF_MEAN|56.72||0.2614|TWO_SIDED|80.0|-171.17|14.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||14.62|-171.17|0.2614
71839414|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|31.7|STANDARD_ERROR_OF_MEAN|37.89||0.4134|TWO_SIDED|80.0|-18.62|81.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||81.98|-18.62|0.4134
71677285|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71677286|NCT01516008|142873160|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71839415|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-69.6|STANDARD_ERROR_OF_MEAN|44.99||0.262|TWO_SIDED|80.0|-154.44|15.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||15.24|-154.44|0.2620
71839416|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|16.7||0.0269|TWO_SIDED|80.0|-62.46|-18.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-18.02|-62.46|0.0269
71839417|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-81.2|STANDARD_ERROR_OF_MEAN|45.32||0.1709|TWO_SIDED|80.0|-155.46|-7.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.02|-155.46|0.1709
71839418|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|42.9|STANDARD_ERROR_OF_MEAN|12.98||0.0042|TWO_SIDED|80.0|25.61|60.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||60.22|25.61|0.0042
71839419|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|47.22||0.3772|TWO_SIDED|80.0|-142.19|35.88||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||35.88|-142.19|0.3772
71839420|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-28.3|STANDARD_ERROR_OF_MEAN|15.54||0.0857|TWO_SIDED|80.0|-49.06|-7.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-7.63|-49.06|0.0857
71839421|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-77.3|STANDARD_ERROR_OF_MEAN|26.34||0.0607|TWO_SIDED|80.0|-120.48|-34.2||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-34.20|-120.48|0.0607
71677287|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
71677288|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours||||<0.001
71677289|NCT01516008|142873161|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||0.021
71839422|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|88.8|STANDARD_ERROR_OF_MEAN|124.79||0.4862|TWO_SIDED|80.0|-77.57|255.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||255.22|-77.57|0.4862
71839423|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-53.2|STANDARD_ERROR_OF_MEAN|49.73||0.3968|TWO_SIDED|80.0|-146.96|40.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.58|-146.96|0.3968
71839424|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|16.57||0.1624|TWO_SIDED|80.0|-46.31|-2.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-2.11|-46.31|0.1624
71839425|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-76.8|STANDARD_ERROR_OF_MEAN|37.75||0.1349|TWO_SIDED|80.0|-138.58|-14.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-14.93|-138.58|0.1349
71839426|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|45.5|STANDARD_ERROR_OF_MEAN|21.81||0.0525|TWO_SIDED|80.0|16.38|74.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||74.56|16.38|0.0525
71839427|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-76.6|STANDARD_ERROR_OF_MEAN|50.98||0.2719|TWO_SIDED|80.0|-172.71|19.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||19.55|-172.71|0.2719
71839428|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-30.7|STANDARD_ERROR_OF_MEAN|17.39||0.0957|TWO_SIDED|80.0|-53.86|-7.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-7.49|-53.86|0.0957
71839429|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-79.8|STANDARD_ERROR_OF_MEAN|32.98||0.0942|TWO_SIDED|80.0|-133.83|-25.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-25.78|-133.83|0.0942
71839430|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|34.6|STANDARD_ERROR_OF_MEAN|23.6||0.1606|TWO_SIDED|80.0|3.16|66.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||66.09|3.16|0.1606
71839431|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-77.0|STANDARD_ERROR_OF_MEAN|42.2||0.2096|TWO_SIDED|80.0|-156.58|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||2.58|-156.58|0.2096
71839432|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|18.32||0.1279|TWO_SIDED|80.0|-53.74|-4.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-4.89|-53.74|0.1279
71839433|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-75.0|STANDARD_ERROR_OF_MEAN|23.17||0.0479|TWO_SIDED|80.0|-112.96|-37.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-37.08|-112.96|0.0479
71839434|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|32.8|STANDARD_ERROR_OF_MEAN|22.91||0.17|TWO_SIDED|80.0|2.28|63.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||63.37|2.28|0.1700
71839435|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-80.1|STANDARD_ERROR_OF_MEAN|29.67||0.1142|TWO_SIDED|80.0|-136.03|-24.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-24.15|-136.03|0.1142
71839436|NCT03858634|143187351|SUPERIORITY||LS Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|20.82||0.398|TWO_SIDED|80.0|-45.8|9.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.71|-45.80|0.3980
71839437|NCT03858634|143187353|SUPERIORITY||LS mean difference|-13.2|STANDARD_ERROR_OF_MEAN|17.11||0.4979|TWO_SIDED|80.0|-41.17|14.86||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||14.86|-41.17|0.4979
71839438|NCT03858634|143187353|SUPERIORITY||LS mean difference|21.7|STANDARD_ERROR_OF_MEAN|12.88||0.1079|TWO_SIDED|80.0|4.63|38.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||38.83|4.63|0.1079
71839439|NCT03858634|143187353|SUPERIORITY||LS mean difference|-35.6|STANDARD_ERROR_OF_MEAN|41.7||0.4837|TWO_SIDED|80.0|-114.19|43.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||43.07|-114.19|0.4837
71839440|NCT03858634|143187353|SUPERIORITY||LS mean difference|-10.5|STANDARD_ERROR_OF_MEAN|4.14||0.0208|TWO_SIDED|80.0|-15.99|-4.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||-4.98|-15.99|0.0208
71839441|NCT03858634|143187353|SUPERIORITY||LS mean difference|-16.2|STANDARD_ERROR_OF_MEAN|23.54||0.5413|TWO_SIDED|80.0|-54.74|22.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||22.38|-54.74|0.5413
71839442|NCT03858634|143187353|SUPERIORITY||LS mean difference|17.5|STANDARD_ERROR_OF_MEAN|12.22||0.1683|TWO_SIDED|80.0|1.28|33.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||33.74|1.28|0.1683
71839443|NCT03858634|143187353|SUPERIORITY||LS mean difference|-58.8|STANDARD_ERROR_OF_MEAN|54.45||0.3933|TWO_SIDED|80.0|-161.43|43.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||43.89|-161.43|0.3933
71794466|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
71794467|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.185|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1850
71794468|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794469|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794470|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794471|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.0887|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
71794472|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794473|NCT01480076|143086477|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892953|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.28||0.167|TWO_SIDED|95.0|-0.95|0.16|||ANOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.16|-0.95|0.167
71677290|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours||||<0.001
71677291|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71677292|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours||||<0.001
71794474|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0011
71794475|NCT01480076|143086477|SUPERIORITY_OR_OTHER|||||||0.1853|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1853
71794476|NCT01480076|143086478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794477|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0005|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0005
71794478|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
71794479|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
71892954|NCT00733902|143307152|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.75|-0.64|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.64|-1.75|<0.001
71794480|NCT01480076|143086478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794481|NCT01480076|143086478|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794482|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0024|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0024
71794483|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0669|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0669
71794484|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0018|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0018
71794485|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0004|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
71794486|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.019|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0190
71794487|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0106|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0106
71794488|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0009|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0009
71794489|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.1937|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1937
71794490|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0445|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0445
71794491|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.6475|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6475
71794492|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0097|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
71839444|NCT03858634|143187353|SUPERIORITY||LS mean difference|-5.7|STANDARD_ERROR_OF_MEAN|6.25||0.3705|TWO_SIDED|80.0|-14.06|2.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.58|-14.06|0.3705
71839445|NCT03858634|143187353|SUPERIORITY||LS mean difference|-23.0|STANDARD_ERROR_OF_MEAN|35.63||0.5644|TWO_SIDED|80.0|-81.36|35.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||35.34|-81.36|0.5644
71839446|NCT03858634|143187353|SUPERIORITY||LS mean difference|6.6|STANDARD_ERROR_OF_MEAN|13.82||0.6384|TWO_SIDED|80.0|-11.75|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||24.94|-11.75|0.6384
71839447|NCT03858634|143187353|SUPERIORITY||LS mean difference|-58.6|STANDARD_ERROR_OF_MEAN|58.62||0.4229|TWO_SIDED|80.0|-169.13|51.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||51.95|-169.13|0.4229
71839448|NCT03858634|143187353|SUPERIORITY||LS mean difference|-16.3|STANDARD_ERROR_OF_MEAN|11.38||0.1688|TWO_SIDED|80.0|-31.47|-1.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.18|-31.47|0.1688
71839449|NCT03858634|143187353|SUPERIORITY||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|28.11||0.1243|TWO_SIDED|80.0|-105.59|-13.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-13.53|-105.59|0.1243
71839450|NCT03858634|143187353|SUPERIORITY||LS mean difference|6.9|STANDARD_ERROR_OF_MEAN|16.79||0.6841|TWO_SIDED|80.0|-15.35|29.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||29.22|-15.35|0.6841
71839451|NCT03858634|143187353|SUPERIORITY||LS mean difference|-53.4|STANDARD_ERROR_OF_MEAN|49.83||0.3963|TWO_SIDED|80.0|-147.31|40.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||40.59|-147.31|0.3963
71839452|NCT03858634|143187353|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|11.85||0.0571|TWO_SIDED|80.0|-39.85|-8.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-8.32|-39.85|0.0571
71794493|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0386|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0386
71794494|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0219|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0219
71794495|NCT01480076|143086478|SUPERIORITY_OR_OTHER|||||||0.0076|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0076
71794496|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.1471|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1471
71794497|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.5503|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5503
71839453|NCT03858634|143187353|SUPERIORITY||LS mean difference|-35.3|STANDARD_ERROR_OF_MEAN|40.32||0.4457|TWO_SIDED|80.0|-101.32|30.73||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||30.73|-101.32|0.4457
71839454|NCT03858634|143187353|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|17.99||0.8075|TWO_SIDED|80.0|-19.44|28.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||28.32|-19.44|0.8075
71839455|NCT03858634|143187353|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|55.75||0.4093|TWO_SIDED|80.0|-162.84|47.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||47.40|-162.84|0.4093
71839456|NCT03858634|143187353|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|13.4||0.0543|TWO_SIDED|80.0|-45.42|-9.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-9.76|-45.42|0.0543
71839457|NCT03858634|143187353|SUPERIORITY||LS mean difference|-31.0|STANDARD_ERROR_OF_MEAN|37.75||0.4711|TWO_SIDED|80.0|-92.88|30.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||30.78|-92.88|0.4711
71839458|NCT03858634|143187353|SUPERIORITY||LS mean difference|13.0|STANDARD_ERROR_OF_MEAN|14.89||0.3925|TWO_SIDED|80.0|-6.74|32.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||32.79|-6.74|0.3925
71677293|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71839459|NCT03858634|143187353|SUPERIORITY||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|61.24||0.5095|TWO_SIDED|80.0|-164.22|66.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||66.72|-164.22|0.5095
71839460|NCT03858634|143187353|SUPERIORITY||LS mean difference|-33.8|STANDARD_ERROR_OF_MEAN|13.22||0.0199|TWO_SIDED|80.0|-51.35|-16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-16.18|-51.35|0.0199
71839461|NCT03858634|143187353|SUPERIORITY||LS mean difference|-42.8|STANDARD_ERROR_OF_MEAN|34.48||0.3029|TWO_SIDED|80.0|-99.26|13.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||13.69|-99.26|0.3029
71839462|NCT03858634|143187353|SUPERIORITY||LS mean difference|10.9|STANDARD_ERROR_OF_MEAN|12.97||0.4094|TWO_SIDED|80.0|-6.28|28.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||28.16|-6.28|0.4094
71839463|NCT03858634|143187353|SUPERIORITY||LS mean difference|-49.8|STANDARD_ERROR_OF_MEAN|58.25||0.4828|TWO_SIDED|80.0|-159.63|60.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||60.05|-159.63|0.4828
71794498|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.3854|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3854
71794499|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.4893|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4893
71839464|NCT03858634|143187353|SUPERIORITY||LS mean difference|-32.8|STANDARD_ERROR_OF_MEAN|14.66||0.0383|TWO_SIDED|80.0|-52.26|-13.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.26|-52.26|0.0383
71839465|NCT03858634|143187353|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|37.1||0.5322|TWO_SIDED|80.0|-86.66|34.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||34.65|-86.66|0.5322
71839466|NCT03858634|143187353|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|13.71||0.6577|TWO_SIDED|80.0|-24.38|12.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||12.03|-24.38|0.6577
71839467|NCT03858634|143187353|SUPERIORITY||LS mean difference|-38.3|STANDARD_ERROR_OF_MEAN|67.21||0.6259|TWO_SIDED|80.0|-165.08|88.4||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||88.40|-165.08|0.6259
71839468|NCT03858634|143187353|SUPERIORITY||LS mean difference|-35.7|STANDARD_ERROR_OF_MEAN|15.27||0.0312|TWO_SIDED|80.0|-56.01|-15.38||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.38|-56.01|0.0312
71839469|NCT03858634|143187353|SUPERIORITY||LS mean difference|-108.3|STANDARD_ERROR_OF_MEAN|18.73||0.0103|TWO_SIDED|80.0|-138.97|-77.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-77.61|-138.97|0.0103
71839470|NCT03858634|143187353|SUPERIORITY||LS mean difference|10.0|STANDARD_ERROR_OF_MEAN|12.43||0.433|TWO_SIDED|80.0|-6.59|26.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||26.56|-6.59|0.4330
71839471|NCT03858634|143187353|SUPERIORITY||LS mean difference|-37.7|STANDARD_ERROR_OF_MEAN|64.23||0.6165|TWO_SIDED|80.0|-158.82|83.39||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||83.39|-158.82|0.6165
71839472|NCT03858634|143187353|SUPERIORITY||LS mean difference|-32.0|STANDARD_ERROR_OF_MEAN|15.13||0.0488|TWO_SIDED|80.0|-52.11|-11.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-11.84|-52.11|0.0488
71677294|NCT01516008|142873161|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours||||<0.001
71839473|NCT03858634|143187353|SUPERIORITY||LS mean difference|-19.2|STANDARD_ERROR_OF_MEAN|39.9||0.6636|TWO_SIDED|80.0|-84.53|46.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||46.16|-84.53|0.6636
71839474|NCT03858634|143187353|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|11.75||0.0583|TWO_SIDED|80.0|8.18|39.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||39.52|8.18|0.0583
71839475|NCT03858634|143187353|SUPERIORITY||LS mean difference|-45.1|STANDARD_ERROR_OF_MEAN|54.87||0.4975|TWO_SIDED|80.0|-148.55|58.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||58.36|-148.55|0.4975
71839476|NCT03858634|143187353|SUPERIORITY||LS mean difference|-30.5|STANDARD_ERROR_OF_MEAN|15.54||0.0653|TWO_SIDED|80.0|-51.17|-9.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-9.82|-51.17|0.0653
71839477|NCT03858634|143187353|SUPERIORITY||LS mean difference|-23.4|STANDARD_ERROR_OF_MEAN|43.98||0.6316|TWO_SIDED|80.0|-95.42|48.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||48.62|-95.42|0.6316
71794500|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.2166|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2166
71794501|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.4149|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4149
71794502|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.3849|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3849
71794503|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.898|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8980
71794504|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.0046|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0046
71673241|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.3|0.9||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PT|95% CI is based on the Miettinen \& Nurminen method.|0.9|-1.3|< 0.001
71673242|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.0|0.5||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis FHA|95% CI is based on the Miettinen \& Nurminen method.|0.5|-1.0|< 0.001
71673243|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-1.3|0.3||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Pertussis PRN|95% CI is based on the Miettinen \& Nurminen method.|0.3|-1.3|< 0.001
71673244|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Hib PRP|95% CI is based on the Miettinen \& Nurminen method.|2.1|-1.3|< 0.001
71673245|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -10% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-2.0|0.0||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: HBsAg|95% CI is based on the Miettinen \& Nurminen method.|-0.0|-2.0|< 0.001
71673246|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 1|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
71673247|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.7||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 2|95% CI is based on the Miettinen \& Nurminen method.|0.7|-0.7|< 0.001
71673248|NCT04031846|142864398|NON_INFERIORITY|Non-inferiority of Infanrix™ hexa administered concomitantly with V114 to Infanrix™ hexa administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevenar 13™) being greater than the -5% specified non-inferiority margin (1-sided p-value \<0.025).|Percentage Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.5|1.1||1-sided p-value|Miettinen & Nurminen||V114 minus Prevenar 13™|Percentage Difference: Poliovirus 3|95% CI is based on the Miettinen \& Nurminen method.|1.1|-0.5|< 0.001
71673249|NCT04031846|142864399|NON_INFERIORITY|Non-inferiority of Rotarix™ administered concomitantly with V114 to Rotarix™ administered concomitantly with Prevenar 13™ is based on the lower bound of the 2-sided 95% CI for the GMT ratio (V114/Prevenar 13™) being \>0.5 (1-sided p-value \<0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.8|1.16||1-sided p-value|t-distribution||V114/Prevenar 13™|GMT Ratio: CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group||1.16|0.80|< 0.001
71673250|NCT04031846|142864400|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.73|0.88|||||V114 / Prevenar 13™|GMC Ratio Serotype 1: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.88|0.73|
71673251|NCT04031846|142864400|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.7|2.02|||||V114 / Prevenar 13™|GMC Ratio Serotype 3: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.02|1.70|
71839478|NCT03858634|143187353|SUPERIORITY||LS mean difference|26.6|STANDARD_ERROR_OF_MEAN|14.68||0.0874|TWO_SIDED|80.0|7.05|46.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||46.18|7.05|0.0874
71839479|NCT03858634|143187353|SUPERIORITY||LS mean difference|-45.0|STANDARD_ERROR_OF_MEAN|50.39||0.4662|TWO_SIDED|80.0|-139.99|50.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||50.03|-139.99|0.4662
71839480|NCT03858634|143187353|SUPERIORITY||LS mean difference|-25.6|STANDARD_ERROR_OF_MEAN|15.12||0.1073|TWO_SIDED|80.0|-45.76|-5.51||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-5.51|-45.76|0.1073
71673252|NCT04031846|142864400|OTHER||GMC Ratio|1.08|||||TWO_SIDED|95.0|0.98|1.19|||||V114 / Prevenar 13™|GMC Ratio Serotype 4: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.98|
71673253|NCT04031846|142864400|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.94|||||V114 / Prevenar 13™|GMC Ratio Serotype 5: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.94|0.74|
71673254|NCT04031846|142864400|OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.4|0.52|||||V114 / Prevenar 13™|GMC Ratio Serotype 6A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.52|0.40|
71673255|NCT04031846|142864400|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.41|||||V114 / Prevenar 13™|GMC Ratio Serotype 6B: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.41|1.00|
71794505|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.0594|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0594
71794506|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.2975|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2975
71839481|NCT03858634|143187353|SUPERIORITY||LS mean difference|-23.3|STANDARD_ERROR_OF_MEAN|42.31||0.6197|TWO_SIDED|80.0|-92.62|45.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||45.96|-92.62|0.6197
71839482|NCT03858634|143187353|SUPERIORITY||LS mean difference|20.6|STANDARD_ERROR_OF_MEAN|14.97||0.1868|TWO_SIDED|80.0|0.63|40.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||40.55|0.63|0.1868
71839483|NCT03858634|143187353|SUPERIORITY||LS mean difference|-55.0|STANDARD_ERROR_OF_MEAN|43.32||0.3321|TWO_SIDED|80.0|-136.65|26.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||26.71|-136.65|0.3321
71839484|NCT03858634|143187353|SUPERIORITY||LS mean difference|-24.8|STANDARD_ERROR_OF_MEAN|15.67||0.131|TWO_SIDED|80.0|-45.64|-3.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-3.95|-45.64|0.1310
71839485|NCT03858634|143187353|SUPERIORITY||LS mean difference|-12.0|STANDARD_ERROR_OF_MEAN|46.49||0.8128|TWO_SIDED|80.0|-88.15|64.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||64.13|-88.15|0.8128
71839486|NCT03858634|143187353|SUPERIORITY||LS mean difference|24.7|STANDARD_ERROR_OF_MEAN|14.23||0.1004|TWO_SIDED|80.0|5.75|43.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||43.69|5.75|0.1004
71839487|NCT03858634|143187353|SUPERIORITY||LS mean difference|-62.8|STANDARD_ERROR_OF_MEAN|44.81||0.2962|TWO_SIDED|80.0|-147.28|21.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||21.71|-147.28|0.2962
71839488|NCT03858634|143187353|SUPERIORITY||LS mean difference|-26.5|STANDARD_ERROR_OF_MEAN|16.4||0.1236|TWO_SIDED|80.0|-48.31|-4.67||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-4.67|-48.31|0.1236
71839489|NCT03858634|143187353|SUPERIORITY||LS mean difference|-4.5|STANDARD_ERROR_OF_MEAN|45.55||0.9276|TWO_SIDED|80.0|-79.1|70.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||70.11|-79.10|0.9276
71839490|NCT03858634|143187353|SUPERIORITY||LS mean difference|19.5|STANDARD_ERROR_OF_MEAN|13.46||0.1657|TWO_SIDED|80.0|1.55|37.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||37.45|1.55|0.1657
71839491|NCT03858634|143187353|SUPERIORITY||LS mean difference|-58.4|STANDARD_ERROR_OF_MEAN|47.8||0.3461|TWO_SIDED|80.0|-148.54|31.71||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||31.71|-148.54|0.3461
71673256|NCT04031846|142864400|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.76|0.91|||||V114 / Prevenar 13™|GMC Ratio Serotype 7F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.91|0.76|
71673257|NCT04031846|142864400|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.96|||||V114 / Prevenar 13™|GMC Ratio Serotype 9V: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.96|0.77|
71673258|NCT04031846|142864400|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.86|||||V114 / Prevenar 13™|GMC Ratio Serotype 14: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.66|
71794507|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.7155|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7155
71839492|NCT03858634|143187353|SUPERIORITY||LS mean difference|-27.6|STANDARD_ERROR_OF_MEAN|16.51||0.1118|TWO_SIDED|80.0|-49.58|-5.64||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-5.64|-49.58|0.1118
71673259|NCT04031846|142864400|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||V114 / Prevenar 13™|GMC Ratio Serotype 18C: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.95|0.77|
71673260|NCT04031846|142864400|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.87|||||V114 / Prevenar 13™|GMC Ratio Serotype 19A: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.87|0.70|
71673261|NCT04031846|142864400|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||V114 / Prevenar 13™|GMC Ratio Serotype 19F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.85|0.70|
71673262|NCT04031846|142864400|OTHER||GMC Ratio|1.22|||||TWO_SIDED|95.0|1.07|1.4|||||V114 / Prevenar 13™|GMC Ratio Serotype 23F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.40|1.07|
71673263|NCT04031846|142864400|OTHER||GMC Ratio|57.69|||||TWO_SIDED|95.0|51.2|65.0|||||V114 / Prevenar 13™|GMC Ratio Serotype 22F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||65.00|51.20|
71673264|NCT04031846|142864400|OTHER||GMC Ratio|6.24|||||TWO_SIDED|95.0|5.46|7.14|||||V114 / Prevenar 13™|GMC Ratio Serotype 33F: CI are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||7.14|5.46|
71673265|NCT04031846|142864401|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-4.4|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 1|95% CI are based on the Miettinen \& Nurminen method.|0.3|-4.4|
71673266|NCT04031846|142864401|OTHER||Percentage Difference|25.7|||||TWO_SIDED|95.0|21.1|30.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 3|95% CI are based on the Miettinen \& Nurminen method.|30.3|21.1|
71673267|NCT04031846|142864401|OTHER||Percentage Difference|-2.9|||||TWO_SIDED|95.0|-5.7|-0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 4|95% CI are based on the Miettinen \& Nurminen method.|-0.3|-5.7|
71673268|NCT04031846|142864401|OTHER||Percentage Difference|-3.9|||||TWO_SIDED|95.0|-8.1|0.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 5|95% CI are based on the Miettinen \& Nurminen method.|0.3|-8.1|
71673269|NCT04031846|142864401|OTHER||Percentage Difference|-19.4|||||TWO_SIDED|95.0|-23.9|-15.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6A|95% CI are based on the Miettinen \& Nurminen method.|-15.0|-23.9|
71794508|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.507|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5070
71673270|NCT04031846|142864401|OTHER||Percentage Difference|4.6|||||TWO_SIDED|95.0|-1.5|10.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 6B|95% CI are based on the Miettinen \& Nurminen method.|10.7|-1.5|
71673271|NCT04031846|142864401|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-2.9|0.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 7F|95% CI are based on the Miettinen \& Nurminen method.|0.5|-2.9|
71673272|NCT04031846|142864401|OTHER||Percentage Difference|-6.7|||||TWO_SIDED|95.0|-10.1|-3.5|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 9V|95% CI are based on the Miettinen \& Nurminen method.|-3.5|-10.1|
71794509|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.5848|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5848
71794510|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.802|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8020
71839493|NCT03858634|143187353|SUPERIORITY||LS mean difference|-18.9|STANDARD_ERROR_OF_MEAN|43.24||0.6912|TWO_SIDED|80.0|-89.75|51.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||51.89|-89.75|0.6912
71673273|NCT04031846|142864401|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 14|95% CI are based on the Miettinen \& Nurminen method.|1.7|-2.6|
71673274|NCT04031846|142864401|OTHER||Percentage Difference|-0.7|||||TWO_SIDED|95.0|-3.9|2.6|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 18C|95% CI are based on the Miettinen \& Nurminen method.|2.6|-3.9|
71673275|NCT04031846|142864401|OTHER||Percentage Difference|-1.2|||||TWO_SIDED|95.0|-3.5|1.0|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19A|95% CI are based on the Miettinen \& Nurminen method.|1.0|-3.5|
71673276|NCT04031846|142864401|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.0|0.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 19F|95% CI are based on the Miettinen \& Nurminen method.|0.7|-2.0|
71673277|NCT04031846|142864401|OTHER||Percentage Difference|6.6|||||TWO_SIDED|95.0|1.3|11.9|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 23F|95% CI are based on the Miettinen \& Nurminen method.|11.9|1.3|
71673278|NCT04031846|142864401|OTHER||Percentage Difference|90.4|||||TWO_SIDED|95.0|87.4|92.7|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 22F|95% CI are based on the Miettinen \& Nurminen method.|92.7|87.4|
71794511|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.254|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2540
71794512|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.9057|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9057
71794513|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.9679|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9679
71794514|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.5875|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5875
71794515|NCT01480076|143086479|SUPERIORITY_OR_OTHER|||||||0.744|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7440
71794516|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0032|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0032
71794517|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0828|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0828
71794518|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.7756|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7756
71794519|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.22|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2200
71794520|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
71839494|NCT03858634|143187353|SUPERIORITY||LS mean difference|22.9|STANDARD_ERROR_OF_MEAN|13.07||0.0973|TWO_SIDED|80.0|5.5|40.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||40.35|5.50|0.0973
71839495|NCT03858634|143187353|SUPERIORITY||LS mean difference|-57.7|STANDARD_ERROR_OF_MEAN|40.33||0.289|TWO_SIDED|80.0|-133.72|18.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||18.37|-133.72|0.2890
71839496|NCT03858634|143187353|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.68||0.231|TWO_SIDED|80.0|-45.43|1.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||1.60|-45.43|0.2310
71839497|NCT03858634|143187353|SUPERIORITY||LS mean difference|-12.7|STANDARD_ERROR_OF_MEAN|45.17||0.7967|TWO_SIDED|80.0|-86.69|61.28||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||61.28|-86.69|0.7967
71839498|NCT03858634|143187353|SUPERIORITY||LS mean difference|16.5|STANDARD_ERROR_OF_MEAN|14.98||0.2868|TWO_SIDED|80.0|-3.5|36.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||36.44|-3.50|0.2868
71839499|NCT03858634|143187353|SUPERIORITY||LS mean difference|-64.9|STANDARD_ERROR_OF_MEAN|38.83||0.2369|TWO_SIDED|80.0|-138.08|8.37||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||8.37|-138.08|0.2369
71673279|NCT04031846|142864401|OTHER||Percentage Difference|45.9|||||TWO_SIDED|95.0|41.3|50.3|||||V114 minus Prevenar 13™|Percentage Difference: Serotype 33F|95% CI are based on the Miettinen \& Nurminen method.|50.3|41.3|
71794521|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0061|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0061
71794522|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.6258|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6258
71794523|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.6987|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6987
71673280|NCT04031846|142864404|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.8|||||TWO_SIDED|95.0|12.9|19.2|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 22F minus Prevenar 13™ Serotype 3||19.2|12.9|
71794524|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0025|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0025
71794525|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0021|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0021
71794526|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.4385|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4385
71794527|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.2275|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2275
71794528|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0446|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0446
71794529|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.5757|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5757
71794530|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.8936|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8936
71839500|NCT03858634|143187353|SUPERIORITY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|17.34||0.2228|TWO_SIDED|80.0|-44.97|1.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||1.17|-44.97|0.2228
71839501|NCT03858634|143187353|SUPERIORITY||LS mean difference|-14.9|STANDARD_ERROR_OF_MEAN|47.51||0.774|TWO_SIDED|80.0|-92.74|62.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||62.89|-92.74|0.7740
71839502|NCT03858634|143187353|SUPERIORITY||LS mean difference|15.1|STANDARD_ERROR_OF_MEAN|14.14||0.3|TWO_SIDED|80.0|-3.74|33.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||33.98|-3.74|0.3000
71839503|NCT03858634|143187353|SUPERIORITY||LS mean difference|-72.4|STANDARD_ERROR_OF_MEAN|31.37||0.1472|TWO_SIDED|80.0|-131.59|-13.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-13.30|-131.59|0.1472
71839504|NCT03858634|143187353|SUPERIORITY||LS mean difference|-12.4|STANDARD_ERROR_OF_MEAN|20.56||0.5536|TWO_SIDED|80.0|-39.77|14.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||14.94|-39.77|0.5536
71839505|NCT03858634|143187353|SUPERIORITY||LS mean difference|-17.6|STANDARD_ERROR_OF_MEAN|43.65||0.7131|TWO_SIDED|80.0|-89.13|53.84||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||53.84|-89.13|0.7131
71839506|NCT03858634|143187353|SUPERIORITY||LS mean difference|13.9|STANDARD_ERROR_OF_MEAN|15.27||0.3762|TWO_SIDED|80.0|-6.49|34.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||34.24|-6.49|0.3762
71673281|NCT04031846|142864404|OTHER|Percentage difference and CI are based on the Miettinen \& Nurminen method.|Percentage Difference|15.3|||||TWO_SIDED|95.0|12.2|18.7|||||V114 minus Prevenar 13™|Percentage Difference: V114 Serotype 33F minus Prevenar 13™ Serotype 3||18.7|12.2|
71673282|NCT06868654|142864405|OTHER||Hazard Ratio (HR)|0.24|||||TWO_SIDED|95.0|0.11|0.56|||||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.56|0.11|
71794531|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.5675|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5675
71794532|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.2539|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.2539
71839507|NCT03858634|143187353|SUPERIORITY||LS mean difference|-74.1|STANDARD_ERROR_OF_MEAN|31.37||0.1419|TWO_SIDED|80.0|-133.26|-14.97||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-14.97|-133.26|0.1419
71673283|NCT00764660|142864437|SUPERIORITY_OR_OTHER||Difference in LS Means|2.4||||0.41|TWO_SIDED|95.0|-3.4|8.2|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||8.2|-3.4|0.41
71673284|NCT00764660|142864438|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-1.9||||0.3|TWO_SIDED|95.0|-5.5|1.7|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||1.7|-5.5|0.30
71673285|NCT00764660|142864439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.52|TWO_SIDED|95.0|0.57|1.33|||Chi-squared|Zero Inflated Negative Binomial (ZINB) Distribution with terms for treatment and region||||1.33|0.57|0.52
71673286|NCT00764660|142864440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.81|TWO_SIDED|95.0|0.71|1.31|||Chi-squared|ZINB Distribution with terms for treatment and region||||1.31|0.71|0.81
71794533|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.6673|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6673
71673287|NCT00764660|142864441|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.26|TWO_SIDED|95.0|0.81|2.12||Model with factors treatment and pooled centers as stratum.|Kaplan-Meier|||||2.12|0.81|0.26
71673288|NCT00764660|142864442|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.59|TWO_SIDED|95.0|-9.9|5.7|||Repeated Measures Model|Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||||5.7|-9.9|0.59
71673289|NCT00764660|142864443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.34|TWO_SIDED|95.0|0.65|3.43|||Regression, Logistic|An Odds Ratio (SCH 900435/Placebo) \>1 means SCH 900435 has a higher probability of achieving complete abstinence.||||3.43|0.65|0.34
71794534|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.0849|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0849
71794535|NCT01480076|143086480|SUPERIORITY_OR_OTHER|||||||0.1187|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1187
71794536|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0022|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0022
71794537|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0299|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0299
71794538|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.8135|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8135
71794539|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.3526|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3526
71839508|NCT03858634|143187353|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|20.74||0.5817|TWO_SIDED|80.0|-39.22|15.95||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||15.95|-39.22|0.5817
71673290|NCT00764660|142864446|SUPERIORITY_OR_OTHER||Difference in LS Means|2.88||||0.54|TWO_SIDED|95.0|-6.3|12.06|||Contrained Longitudinal Data Analysis||Constrained Longitudinal Data Analysis (cLDA) Model with terms for treatment, pooled centers, assessment by treatment interaction.|||12.06|-6.30|0.54
71673291|NCT00764660|142864447|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.51|TWO_SIDED|95.0|-12.35|6.15|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||6.15|-12.35|0.51
71673292|NCT00764660|142864448|SUPERIORITY_OR_OTHER||Difference in LS Means|-9.17||||0.05|TWO_SIDED|95.0|-18.27|-0.07|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.|||-0.07|-18.27|0.05
71673293|NCT01540487|142864461|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.5|||ANOVA|||||104.5|94.7|
71673294|NCT01540487|142864461|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
71673295|NCT01540487|142864462|SUPERIORITY_OR_OTHER||adjusted gMean ratio|101.9|||||TWO_SIDED|90.0|95.4|109.0|||ANOVA|||||109.0|95.4|
71673296|NCT01540487|142864462|SUPERIORITY_OR_OTHER||adjusted gMean ratio|111.4|||||TWO_SIDED|90.0|100.4|123.5|||ANOVA|||||123.5|100.4|
71673297|NCT01540487|142864463|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.0|||||TWO_SIDED|90.0|90.6|103.8|||ANOVA|||||103.8|90.6|
71673298|NCT01540487|142864463|SUPERIORITY_OR_OTHER||adjusteg gMean ratio|103.0|||||TWO_SIDED|90.0|96.2|110.1|||ANOVA|||||110.1|96.2|
71794540|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
71794541|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0039|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0039
71794542|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.6924|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.6924
71794543|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.7639|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.7639
71794544|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0013|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0013
71794545|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0011|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0011
71794546|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.434|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4340
71794547|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.4224|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.4224
71794548|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.1628|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1628
71794549|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.5666|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5666
71794550|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.8315|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.8315
71794551|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.3852|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.3852
71794552|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.0652|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0652
71794553|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.5719|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.5719
71794554|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.9237|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.9237
71839509|NCT03858634|143187355|SUPERIORITY||LS mean difference|27.7|STANDARD_ERROR_OF_MEAN|55.77||0.6532|TWO_SIDED|80.0|-63.6|119.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||119.06|-63.60|0.6532
71839510|NCT03858634|143187355|SUPERIORITY||LS mean difference|23.6|STANDARD_ERROR_OF_MEAN|9.23||0.0187|TWO_SIDED|80.0|11.38|35.85||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||35.85|11.38|0.0187
71839511|NCT03858634|143187355|SUPERIORITY||LS mean difference|-39.3|STANDARD_ERROR_OF_MEAN|44.53||0.4707|TWO_SIDED|80.0|-123.27|44.68||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||44.68|-123.27|0.4707
71839512|NCT03858634|143187355|SUPERIORITY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|4.81||0.7108|TWO_SIDED|80.0|-8.22|4.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 1||4.59|-8.22|0.7108
71794555|NCT01480076|143086481|SUPERIORITY_OR_OTHER|||||||0.131|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1310
71794556|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794557|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794558|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
71794559|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0003|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0003
71794560|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794561|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794562|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0002
71794563|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0102
71673299|NCT01540487|142864464|SUPERIORITY_OR_OTHER||adjusted gMean ratio|94.6|||||TWO_SIDED|90.0|85.4|104.8|||ANOVA|||||104.8|85.4|
71794564|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794565|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71673300|NCT01540487|142864464|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.5|||||TWO_SIDED|90.0|92.2|113.9|||ANOVA|||||113.9|92.2|
71794566|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0001
71794567|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0012|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0012
71794568|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71673301|NCT01540487|142864465|SUPERIORITY_OR_OTHER||adjusted gMean ratio|110.1|||||TWO_SIDED|90.0|100.5|120.6|||ANOVA|||||120.6|100.5|
71673302|NCT01540487|142864465|SUPERIORITY_OR_OTHER||adjusted gMean ratio|89.3|||||TWO_SIDED|90.0|80.2|99.3|||ANOVA|||||99.3|80.2|
71794569|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794570|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0026|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0026
71794571|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.0161|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0161
71794572|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794573|NCT01480076|143086482|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||<0.0001
71794574|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.1151|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.1151
71794575|NCT01480076|143086482|SUPERIORITY_OR_OTHER|||||||0.004|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.||||0.0040
71794576|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794577|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.6769|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6769
71794578|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794579|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5780
71794580|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|3.4|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794581|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|4.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794582|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794583|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.8886|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8886
71839513|NCT03858634|143187355|SUPERIORITY||LS mean difference|22.4|STANDARD_ERROR_OF_MEAN|60.36||0.7355|TWO_SIDED|80.0|-76.47|121.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||121.23|-76.47|0.7355
71673303|NCT01540487|142864466|SUPERIORITY_OR_OTHER||adjusted gMean ratio|98.0|||||TWO_SIDED|90.0|92.0|104.5|||ANOVA|||||104.5|92.0|
71673304|NCT01540487|142864466|SUPERIORITY_OR_OTHER||adjusted gMean ratio|102.8|||||TWO_SIDED|90.0|97.0|109.0|||ANOVA|||||109.0|97.0|
71673305|NCT01540487|142864467|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.5|||||TWO_SIDED|90.0|94.7|104.6|||ANOVA|||||104.6|94.7|
71673306|NCT01540487|142864467|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.8|||||TWO_SIDED|90.0|95.1|106.8|||ANOVA|||||106.8|95.1|
71673307|NCT03503370|142864468|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.39|1.8|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.80|0.39|
71673308|NCT03503370|142864469|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71673309|NCT03503370|142864470|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.34|1.77|||||Hazard ratio from Cox Proportional Hazard comparing the chlorhexidine group to the placebo group.|||1.77|0.34|
71673310|NCT01598064|142864490|SUPERIORITY_OR_OTHER|||||||0.25|||||||Chi-squared|||||||0.25
71673311|NCT04506463|142864495|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
71673312|NCT04506463|142864495|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
71673313|NCT04506463|142864495|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||0.850
71673314|NCT04506463|142864496|SUPERIORITY|||||||0.062|||||||Mixed Models Analysis|||||||0.062
71673315|NCT04506463|142864496|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71794584|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794585|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.3221|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3221
71839514|NCT03858634|143187355|SUPERIORITY||LS mean difference|16.9|STANDARD_ERROR_OF_MEAN|13.27||0.2167|TWO_SIDED|80.0|-0.66|34.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||34.52|-0.66|0.2167
71839515|NCT03858634|143187355|SUPERIORITY||LS mean difference|-63.5|STANDARD_ERROR_OF_MEAN|60.8||0.4058|TWO_SIDED|80.0|-178.16|51.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||51.13|-178.16|0.4058
71673316|NCT04506463|142864496|SUPERIORITY|||||||0.936|||||||Mixed Models Analysis|||||||0.936
71673317|NCT04506463|142864497|SUPERIORITY|||||||0.042|||||||Mixed Models Analysis|||||||0.042
71673318|NCT04506463|142864497|SUPERIORITY|||||||0.037|||||||Mixed Models Analysis|||||||0.037
71673319|NCT04506463|142864497|SUPERIORITY|||||||0.648|||||||Mixed Models Analysis|||||||0.648
71673320|NCT01754129|142864511|OTHER||||||<|0.001||||||Missing values were replaced using the Last Observation Carried Forward (LOCF) technique for data of questionnaires. Missing data at Visit 3 was replaced with the (non-missing) data recorded at Visit 2.|Paired t-test|||Mean change from baseline to Visit 3||||<0.001
71673321|NCT01754129|142864511|OTHER||||||<|0.001|||||||Paired t-test|||Change from baseline to Visit 2||||<0.001
71673322|NCT01609010|142864526|SUPERIORITY_OR_OTHER|||||||0.3023|||||||Log Rank|||||||0.3023
71673323|NCT01609010|142864527|SUPERIORITY_OR_OTHER|||||||0.3362|||||||Chi-squared|||Week 10, Cycle 1||||0.3362
71673324|NCT01609010|142864527|SUPERIORITY_OR_OTHER|||||||0.1157|||||||Chi-squared|||Week 16, Cycle 2||||0.1157
71673325|NCT01609010|142864528|SUPERIORITY_OR_OTHER|||||||0.854|||||||Chi-squared|||Week 10, Cycle 1||||0.8540
71839516|NCT03858634|143187355|SUPERIORITY||LS mean difference|-6.4|STANDARD_ERROR_OF_MEAN|6.43||0.3323|TWO_SIDED|80.0|-14.95|2.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 2||2.15|-14.95|0.3323
71673326|NCT01609010|142864528|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Chi-squared|||Week 16, Cycle 2||||0.0051
71673327|NCT01609010|142864530|SUPERIORITY_OR_OTHER|||||||0.784|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu+PR||||0.7840
71673328|NCT01609010|142864530|SUPERIORITY_OR_OTHER|||||||0.4419|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu||||0.4419
71673329|NCT01609010|142864530|SUPERIORITY_OR_OTHER|||||||0.5942|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR only||||0.5942
71673330|NCT01609010|142864532|SUPERIORITY_OR_OTHER|||||||0.8946|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.8946
71673331|NCT01609010|142864534|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).||||||0.4963
71673332|NCT03150719|142864552|SUPERIORITY||Mean Difference|2.7|||||TWO_SIDED|95.0|1.0|4.4||||||||4.4|1.0|
71673333|NCT03150719|142864553|SUPERIORITY||Mean Difference|6.7|||||TWO_SIDED|95.0|2.5|10.9||||||||10.9|2.5|
71673334|NCT03150719|142864554|SUPERIORITY||Mean Difference|1.1|||||TWO_SIDED|95.0|-4.9|7.0||||||||7.0|-4.9|
71677295|NCT01516008|142873162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.52|||<|0.001|TWO_SIDED|95.0|11.1|22.0|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||22.0|11.1|<0.001
71677296|NCT01516008|142873162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.11|||<|0.001|TWO_SIDED|95.0|13.6|24.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours||24.6|13.6|<0.001
71677297|NCT01516008|142873162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.71|||<|0.001|TWO_SIDED|95.0|23.2|46.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||46.2|23.2|<0.001
71794586|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794587|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|5.3|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794588|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794589|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.4668|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4668
71794590|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794591|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.5695|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5695
71794592|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|2.4|STANDARD_ERROR_OF_MEAN|0.88||0.0058|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0058
71794593|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|1.4||0.001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0010
71794594|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794595|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.204|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2040
71794596|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794597|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.6306|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6306
71794598|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|3.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non- responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839517|NCT03858634|143187355|SUPERIORITY||LS mean difference|34.3|STANDARD_ERROR_OF_MEAN|68.11||0.6496|TWO_SIDED|80.0|-77.29|145.8||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||145.80|-77.29|0.6496
71839518|NCT03858634|143187355|SUPERIORITY||LS mean difference|13.8|STANDARD_ERROR_OF_MEAN|12.76||0.2925|TWO_SIDED|80.0|-3.12|30.7||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||30.70|-3.12|0.2925
71677298|NCT01516008|142873162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.04|||<|0.001|TWO_SIDED|95.0|31.5|54.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours||54.6|31.5|<0.001
71677299|NCT01516008|142873162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|122.32|||<|0.001|TWO_SIDED|95.0|81.8|162.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||162.9|81.8|<0.001
71794599|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|1.51||0.002|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0020
71677300|NCT01516008|142873162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.57|||<|0.001||95.0|97.8|179.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours||179.4|97.8|<0.001
71794600|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794601|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.4052|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4052
71794602|NCT01480076|143086483|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794603|NCT01480076|143086483|SUPERIORITY_OR_OTHER|||||||0.8626|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8626
71794604|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|0.93||0.0004|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
71794605|NCT01480076|143086483|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.49||0.0263|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0263
71794606|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794607|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.8999|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8999
71794608|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794609|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.7156|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7156
71794610|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|2.9|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0050
71677301|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.15|||<|0.001|TWO_SIDED|95.0|5.0|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|5.0|<0.001
71677302|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.13|||<|0.001|TWO_SIDED|95.0|4.9|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours||9.3|4.9|<0.001
71794611|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|3.3|STANDARD_ERROR_OF_MEAN|1.68||0.049|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0490
71794612|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839519|NCT03858634|143187355|SUPERIORITY||LS mean difference|-70.7|STANDARD_ERROR_OF_MEAN|67.98||0.4074|TWO_SIDED|80.0|-198.92|57.46||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||57.46|-198.92|0.4074
71677303|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.21|||<|0.001|TWO_SIDED|95.0|10.6|19.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||19.8|10.6|<0.001
71677304|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.54|||<|0.001|TWO_SIDED|95.0|10.9|20.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours||20.2|10.9|<0.001
71677305|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.76|||<|0.001|TWO_SIDED|95.0|24.3|45.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||45.3|24.3|<0.001
71794613|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.274|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2740
71794614|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794615|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.5556|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5556
71794616|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|5.2|STANDARD_ERROR_OF_MEAN|1.15|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794617|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|3.7|STANDARD_ERROR_OF_MEAN|1.88||0.0476|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0476
71794618|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794619|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.8627|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8627
71839520|NCT03858634|143187355|OTHER||LS mean difference|-15.5|STANDARD_ERROR_OF_MEAN|10.56||0.1584|TWO_SIDED|80.0|-29.6|-1.49||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 3||-1.49|-29.60|0.1584
71839521|NCT03858634|143187355|SUPERIORITY||LS mean difference|-22.8|STANDARD_ERROR_OF_MEAN|54.04||0.7013|TWO_SIDED|80.0|-111.31|65.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||65.69|-111.31|0.7013
71839522|NCT03858634|143187355|SUPERIORITY||LS mean difference|13.4|STANDARD_ERROR_OF_MEAN|16.35||0.423|TWO_SIDED|80.0|-8.3|35.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||35.05|-8.30|0.4230
71677306|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.6|||<|0.001|TWO_SIDED|95.0|23.0|44.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours||44.2|23.0|<0.001
71839523|NCT03858634|143187355|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|57.96||0.4055|TWO_SIDED|80.0|-169.9|48.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||48.69|-169.90|0.4055
71794620|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794621|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.4312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4312
71794622|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.27||0.0305|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0305
71794623|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|2.6|STANDARD_ERROR_OF_MEAN|2.03||0.2059|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2059
71794624|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.0008|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0008
71794625|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.3685|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3685
71794626|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.0016|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0016
71794627|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.9862|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9862
71794628|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.38||0.5561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5561
71794629|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|2.32||0.2281|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2281
71794630|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.0006|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0006
71794631|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.6004|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6004
71794632|NCT01480076|143086484|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794633|NCT01480076|143086484|SUPERIORITY_OR_OTHER|||||||0.904|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9040
71677307|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.59|||<|0.001|TWO_SIDED|95.0|39.4|73.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||73.8|39.4|<0.001
71794634|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|2.8|STANDARD_ERROR_OF_MEAN|1.38||0.0401|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0401
71794635|NCT01480076|143086484|SUPERIORITY_OR_OTHER||difference of LS means|4.1|STANDARD_ERROR_OF_MEAN|2.23||0.0651|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0651
71794636|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794637|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.454|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4540
71794638|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794639|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.2949|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2949
71794640|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-8.1|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794641|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-9.0|STANDARD_ERROR_OF_MEAN|3.16||0.0046|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0046
71794642|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-12.6|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794643|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.502|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5020
71794644|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794645|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.2157|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2157
71794646|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-11.2|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794647|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-10.0|STANDARD_ERROR_OF_MEAN|3.3||0.0026|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
71673335|NCT01790984|142864557|OTHER||General linear mixed model|2.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing differences between 2 Groups on 2 Diets (NAFLD, Control,high \& low sugar diets).|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TAG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71677308|NCT01516008|142873163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|53.48|||<|0.001|TWO_SIDED|95.0|36.2|70.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours||70.8|36.2|<0.001
71794648|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794649|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.3435|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3435
71794650|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794651|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.1357|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1357
71794652|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-7.8|STANDARD_ERROR_OF_MEAN|2.22||0.0004|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
71794653|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-7.0|STANDARD_ERROR_OF_MEAN|3.58||0.0511|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0511
71794654|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794655|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.8703|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8703
71794656|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794657|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.9049|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9049
71839524|NCT03858634|143187355|SUPERIORITY||LS mean difference|-22.7|STANDARD_ERROR_OF_MEAN|11.82||0.0709|TWO_SIDED|80.0|-38.41|-6.96||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.96|-38.41|0.0709
71839525|NCT03858634|143187355|SUPERIORITY||LS mean difference|17.7|STANDARD_ERROR_OF_MEAN|74.17||0.8268|TWO_SIDED|80.0|-103.77|139.17||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||139.17|-103.77|0.8268
71839526|NCT03858634|143187355|SUPERIORITY||LS mean difference|12.4|STANDARD_ERROR_OF_MEAN|14.63||0.4082|TWO_SIDED|80.0|-7.03|31.75||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||31.75|-7.03|0.4082
71839527|NCT03858634|143187355|SUPERIORITY||LS mean difference|-50.4|STANDARD_ERROR_OF_MEAN|58.86||0.4818|TWO_SIDED|80.0|-161.43|60.56||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||60.56|-161.43|0.4818
71839528|NCT03858634|143187355|SUPERIORITY||LS mean difference|-27.1|STANDARD_ERROR_OF_MEAN|13.93||0.0673|TWO_SIDED|80.0|-45.64|-8.58||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 5||-8.58|-45.64|0.0673
71839529|NCT03858634|143187355|SUPERIORITY||LS mean difference|29.6|STANDARD_ERROR_OF_MEAN|82.15||0.7429|TWO_SIDED|80.0|-105.0|164.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||164.10|-105.00|0.7429
71839530|NCT03858634|143187355|SUPERIORITY||LS mean difference|21.8|STANDARD_ERROR_OF_MEAN|13.55||0.1227|TWO_SIDED|80.0|3.88|39.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||39.79|3.88|0.1227
71839531|NCT03858634|143187355|SUPERIORITY||LS mean difference|-47.5|STANDARD_ERROR_OF_MEAN|58.06||0.4996|TWO_SIDED|80.0|-156.95|62.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||62.02|-156.95|0.4996
71839532|NCT03858634|143187355|SUPERIORITY||LS mean difference|-33.6|STANDARD_ERROR_OF_MEAN|13.69||0.0244|TWO_SIDED|80.0|-51.87|-15.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 6||-15.43|-51.87|0.0244
71839533|NCT03858634|143187355|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|64.24||0.9967|TWO_SIDED|80.0|-105.5|104.92||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||104.92|-105.50|0.9967
71839534|NCT03858634|143187355|SUPERIORITY||LS mean difference|19.1|STANDARD_ERROR_OF_MEAN|13.57||0.1739|TWO_SIDED|80.0|1.15|37.12||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||37.12|1.15|0.1739
71677309|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.66|||<|0.001|TWO_SIDED|95.0|16.4|30.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||30.9|16.4|<0.001
71839535|NCT03858634|143187355|SUPERIORITY||LS mean difference|-55.1|STANDARD_ERROR_OF_MEAN|51.61||0.3978|TWO_SIDED|80.0|-152.39|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||42.26|-152.39|0.3978
71839536|NCT03858634|143187355|SUPERIORITY||LS mean difference|-32.7|STANDARD_ERROR_OF_MEAN|14.73||0.0397|TWO_SIDED|80.0|-52.26|-13.07||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 7||-13.07|-52.26|0.0397
71839537|NCT03858634|143187355|SUPERIORITY||LS mean difference|10.4|STANDARD_ERROR_OF_MEAN|70.66||0.8922|TWO_SIDED|80.0|-105.32|126.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||126.14|-105.32|0.8922
71839538|NCT03858634|143187355|SUPERIORITY||LS mean difference|17.3|STANDARD_ERROR_OF_MEAN|14.43||0.2439|TWO_SIDED|80.0|-1.8|36.45||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||36.45|-1.80|0.2439
71839539|NCT03858634|143187355|SUPERIORITY||LS mean difference|-50.3|STANDARD_ERROR_OF_MEAN|37.1||0.3076|TWO_SIDED|80.0|-120.29|19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||19.61|-120.29|0.3076
71677310|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.24|||<|0.001|TWO_SIDED|95.0|18.9|33.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours||33.6|18.9|<0.001
71839540|NCT03858634|143187355|SUPERIORITY||LS mean difference|-36.4|STANDARD_ERROR_OF_MEAN|15.7||0.0322|TWO_SIDED|80.0|-57.32|-15.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-15.55|-57.32|0.0322
71839541|NCT03858634|143187355|SUPERIORITY||LS mean difference|-94.7|STANDARD_ERROR_OF_MEAN|27.67||0.0418|TWO_SIDED|80.0|-139.98|-49.36||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-49.36|-139.98|0.0418
71839542|NCT03858634|143187355|SUPERIORITY||LS mean difference|24.4|STANDARD_ERROR_OF_MEAN|13.44||0.0865|TWO_SIDED|80.0|6.49|42.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||42.26|6.49|0.0865
71839543|NCT03858634|143187355|SUPERIORITY||LS mean difference|-48.9|STANDARD_ERROR_OF_MEAN|40.32||0.3489|TWO_SIDED|80.0|-124.96|27.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||27.11|-124.96|0.3489
71839544|NCT03858634|143187355|SUPERIORITY||LS mean difference|-38.1|STANDARD_ERROR_OF_MEAN|15.99||0.0286|TWO_SIDED|80.0|-59.34|-16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 9||-16.79|-59.34|0.0286
71839545|NCT03858634|143187355|SUPERIORITY||LS mean difference|28.6|STANDARD_ERROR_OF_MEAN|72.63||0.7198|TWO_SIDED|80.0|-90.32|147.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||147.59|-90.32|0.7198
71839546|NCT03858634|143187355|SUPERIORITY||LS mean difference|39.0|STANDARD_ERROR_OF_MEAN|13.27||0.0088|TWO_SIDED|80.0|21.32|56.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||56.63|21.32|0.0088
71839547|NCT03858634|143187355|SUPERIORITY||LS mean difference|-56.5|STANDARD_ERROR_OF_MEAN|33.87||0.2371|TWO_SIDED|80.0|-120.39|7.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||7.34|-120.39|0.2371
71839548|NCT03858634|143187355|SUPERIORITY||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|16.14||0.021|TWO_SIDED|80.0|-62.3|-19.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 10||-19.35|-62.30|0.0210
71839549|NCT03858634|143187355|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|54.07||0.7312|TWO_SIDED|80.0|-68.17|108.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||108.94|-68.17|0.7312
71839550|NCT03858634|143187355|SUPERIORITY||LS mean difference|39.4|STANDARD_ERROR_OF_MEAN|14.64||0.015|TWO_SIDED|80.0|19.88|58.83||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||58.83|19.88|0.0150
71839551|NCT03858634|143187355|SUPERIORITY||LS mean difference|-53.3|STANDARD_ERROR_OF_MEAN|33.87||0.2559|TWO_SIDED|80.0|-117.22|10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||10.52|-117.22|0.2559
71839552|NCT03858634|143187355|SUPERIORITY||LS mean difference|-35.0|STANDARD_ERROR_OF_MEAN|15.97||0.0419|TWO_SIDED|80.0|-56.21|-13.72||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 11||-13.72|-56.21|0.0419
71794658|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-7.6|STANDARD_ERROR_OF_MEAN|2.44||0.0019|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0019
71794659|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-12.3|STANDARD_ERROR_OF_MEAN|4.15||0.0033|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0033
71794660|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794661|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.4087|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4087
71794662|NCT01480076|143086485|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794663|NCT01480076|143086485|SUPERIORITY_OR_OTHER|||||||0.2755|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2755
71794664|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-5.7|STANDARD_ERROR_OF_MEAN|2.52||0.0251|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0251
71839553|NCT03858634|143187355|SUPERIORITY||LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|60.66||0.7589|TWO_SIDED|80.0|-78.95|119.74||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||119.74|-78.95|0.7589
71839554|NCT03858634|143187355|SUPERIORITY||LS mean difference|39.1|STANDARD_ERROR_OF_MEAN|17.42||0.0374|TWO_SIDED|80.0|15.97|62.31||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||62.31|15.97|0.0374
71839555|NCT03858634|143187355|SUPERIORITY||LS mean difference|-54.9|STANDARD_ERROR_OF_MEAN|33.87||0.2463|TWO_SIDED|80.0|-118.8|8.93||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.93|-118.80|0.2463
71839556|NCT03858634|143187355|SUPERIORITY||LS mean difference|-33.2|STANDARD_ERROR_OF_MEAN|16.78||0.0632|TWO_SIDED|80.0|-55.56|-10.9||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-10.90|-55.56|0.0632
71839557|NCT03858634|143187355|SUPERIORITY||LS mean difference|25.7|STANDARD_ERROR_OF_MEAN|61.73||0.7053|TWO_SIDED|80.0|-75.41|126.78||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||126.78|-75.41|0.7053
71839558|NCT03858634|143187355|SUPERIORITY||LS mean difference|38.7|STANDARD_ERROR_OF_MEAN|16.25||0.0285|TWO_SIDED|80.0|17.09|60.34||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||60.34|17.09|0.0285
71839559|NCT03858634|143187355|SUPERIORITY||LS mean difference|-64.6|STANDARD_ERROR_OF_MEAN|37.1||0.2236|TWO_SIDED|80.0|-134.58|5.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||5.32|-134.58|0.2236
71839560|NCT03858634|143187355|OTHER||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.38||0.0558|TWO_SIDED|80.0|-58.65|-12.41||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 13||-12.41|-58.65|0.0558
71839561|NCT03858634|143187355|SUPERIORITY||LS mean difference|29.9|STANDARD_ERROR_OF_MEAN|72.86||0.7089|TWO_SIDED|80.0|-89.41|149.24||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||149.24|-89.41|0.7089
71839562|NCT03858634|143187355|SUPERIORITY||LS mean difference|33.7|STANDARD_ERROR_OF_MEAN|14.76||0.0347|TWO_SIDED|80.0|14.08|53.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||53.35|14.08|0.0347
71839563|NCT03858634|143187355|SUPERIORITY||LS mean difference|-60.9|STANDARD_ERROR_OF_MEAN|41.94||0.2835|TWO_SIDED|80.0|-139.99|18.16||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||18.16|-139.99|0.2835
71794665|NCT01480076|143086485|SUPERIORITY_OR_OTHER||difference of LS means|-6.7|STANDARD_ERROR_OF_MEAN|4.08||0.0989|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0989
71839564|NCT03858634|143187355|SUPERIORITY||LS mean difference|-35.5|STANDARD_ERROR_OF_MEAN|17.11||0.0525|TWO_SIDED|80.0|-58.31|-12.77||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 14||-12.77|-58.31|0.0525
71839565|NCT03858634|143187355|SUPERIORITY||LS mean difference|24.0|STANDARD_ERROR_OF_MEAN|64.52||0.7347|TWO_SIDED|80.0|-81.68|129.66||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||129.66|-81.68|0.7347
71839566|NCT03858634|143187355|SUPERIORITY||LS mean difference|31.0|STANDARD_ERROR_OF_MEAN|13.94||0.039|TWO_SIDED|80.0|12.5|49.6||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||49.60|12.50|0.0390
71839567|NCT03858634|143187355|SUPERIORITY||LS mean difference|-60.6|STANDARD_ERROR_OF_MEAN|35.48||0.2299|TWO_SIDED|80.0|-127.49|6.33||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||6.33|-127.49|0.2299
71839568|NCT03858634|143187355|SUPERIORITY||LS mean difference|-32.6|STANDARD_ERROR_OF_MEAN|18.11||0.0884|TWO_SIDED|80.0|-56.7|-8.53||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 15||-8.53|-56.70|0.0884
71839569|NCT03858634|143187355|SUPERIORITY||LS mean difference|16.3|STANDARD_ERROR_OF_MEAN|61.44||0.8085|TWO_SIDED|80.0|-84.37|116.87||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||116.87|-84.37|0.8085
71839570|NCT03858634|143187355|SUPERIORITY||LS mean difference|19.9|STANDARD_ERROR_OF_MEAN|15.96||0.2283|TWO_SIDED|80.0|-1.33|41.14||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||41.14|-1.33|0.2283
71839571|NCT03858634|143187355|SUPERIORITY||LS mean difference|-69.9|STANDARD_ERROR_OF_MEAN|32.26||0.1625|TWO_SIDED|80.0|-130.76|-9.11||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-9.11|-130.76|0.1625
71839572|NCT03858634|143187355|SUPERIORITY||LS mean difference|-34.2|STANDARD_ERROR_OF_MEAN|17.8||0.0707|TWO_SIDED|80.0|-57.87|-10.52||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-10.52|-57.87|0.0707
71839573|NCT03858634|143187355|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|50.17||0.9944|TWO_SIDED|80.0|-81.79|82.55||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||82.55|-81.79|0.9944
71839574|NCT03858634|143187355|SUPERIORITY||LS mean difference|23.9|STANDARD_ERROR_OF_MEAN|15.16||0.1327|TWO_SIDED|80.0|3.71|44.05||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||44.05|3.71|0.1327
71839575|NCT03858634|143187355|SUPERIORITY||LS mean difference|-69.2|STANDARD_ERROR_OF_MEAN|33.87||0.1777|TWO_SIDED|80.0|-133.09|-5.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||-5.35|-133.09|0.1777
71839576|NCT03858634|143187355|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.4||0.2796|TWO_SIDED|80.0|-52.34|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 17||4.61|-52.34|0.2796
71839577|NCT03858634|143187355|SUPERIORITY||LS mean difference|7.6|STANDARD_ERROR_OF_MEAN|55.4||0.8999|TWO_SIDED|80.0|-83.15|98.3||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||98.30|-83.15|0.8999
71839578|NCT03858634|143187355|SUPERIORITY||LS mean difference|22.0|STANDARD_ERROR_OF_MEAN|15.99||0.1867|TWO_SIDED|80.0|0.68|43.23||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||43.23|0.68|0.1867
71839579|NCT03858634|143187355|SUPERIORITY||LS mean difference|-70.8|STANDARD_ERROR_OF_MEAN|33.87||0.1717|TWO_SIDED|80.0|-134.68|-6.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-6.94|-134.68|0.1717
71839580|NCT03858634|143187355|SUPERIORITY||LS mean difference|-23.9|STANDARD_ERROR_OF_MEAN|21.46||0.2792|TWO_SIDED|80.0|-52.5|4.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||4.61|-52.50|0.2792
71839581|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|31.41||0.2289|TWO_SIDED|80.0|-98.77|4.1||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||4.10|-98.77|0.2289
71839582|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|19.6|STANDARD_ERROR_OF_MEAN|14.08||0.1788|TWO_SIDED|80.0|0.96|38.27||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||38.27|0.96|0.1788
71673336|NCT01790984|142864558|OTHER||General linear mixed model|11.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size for NAFLD \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B and triacylglycerol production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level) produced sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71673337|NCT01790984|142864559|OTHER||General linear mixed model|110.0|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71673338|NCT01790984|142864560|OTHER||General linear mixed model|0.26|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical approach are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71677311|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.93|||<|0.001|TWO_SIDED|95.0|34.4|65.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||65.4|34.4|<0.001
71677312|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.58|||<|0.001|TWO_SIDED|95.0|43.0|74.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours||74.2|43.0|<0.001
71794666|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794667|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.8767|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8767
71839583|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-59.6|STANDARD_ERROR_OF_MEAN|114.35||0.6544|TWO_SIDED|80.0|-275.19|156.06||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||156.06|-275.19|0.6544
71839584|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-72.2|STANDARD_ERROR_OF_MEAN|20.4||0.0023|TWO_SIDED|80.0|-99.39|-45.09||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-45.09|-99.39|0.0023
71839585|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-14.47|-89.68|0.1081
71839586|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|21.37||0.4926|TWO_SIDED|80.0|-13.39|43.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||43.26|-13.39|0.4926
71839587|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||467.98|-361.63|0.8315
71839588|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-69.9|STANDARD_ERROR_OF_MEAN|18.56||0.0014|TWO_SIDED|80.0|-94.61|-45.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-45.22|-94.61|0.0014
71839589|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-52.1|STANDARD_ERROR_OF_MEAN|22.96||0.1081|TWO_SIDED|80.0|-89.68|-14.47||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-14.47|-89.68|0.1081
71839590|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|21.97||0.7339|TWO_SIDED|80.0|-21.65|36.82||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||36.82|-21.65|0.7339
71794668|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794669|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.3673|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3673
71794670|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-6.8|STANDARD_ERROR_OF_MEAN|1.91||0.0004|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0004
71794671|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.12||0.0273|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0273
71794672|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839591|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|53.2|STANDARD_ERROR_OF_MEAN|219.98||0.8315|TWO_SIDED|80.0|-361.63|467.98||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||467.98|-361.63|0.8315
71839592|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-67.6|STANDARD_ERROR_OF_MEAN|21.26||0.0055|TWO_SIDED|80.0|-95.92|-39.22||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-39.22|-95.92|0.0055
71839593|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-57.9|STANDARD_ERROR_OF_MEAN|26.73||0.1188|TWO_SIDED|80.0|-101.7|-14.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-14.15|-101.70|0.1188
71839594|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|18.27||0.8697|TWO_SIDED|80.0|-21.26|27.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||27.35|-21.26|0.8697
71839595|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|78.64||0.7368|TWO_SIDED|80.0|-178.62|117.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||117.94|-178.62|0.7368
71839596|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|15.02||0.5571|TWO_SIDED|80.0|-29.03|11.03||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||11.03|-29.03|0.5571
71839597|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-49.1|STANDARD_ERROR_OF_MEAN|32.21||0.2251|TWO_SIDED|80.0|-101.8|3.69||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||3.69|-101.80|0.2251
71839598|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|17.3|STANDARD_ERROR_OF_MEAN|18.93||0.3733|TWO_SIDED|80.0|-7.9|42.48||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||42.48|-7.90|0.3733
71839599|NCT03858634|143187357|SUPERIORITY||LS Mean Difference|-22.6|STANDARD_ERROR_OF_MEAN|66.57||0.7662|TWO_SIDED|80.0|-148.16|102.89||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||102.89|-148.16|0.7662
71839600|NCT03858634|143187357|OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|16.87||0.7241|TWO_SIDED|80.0|-28.54|16.44||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||16.44|-28.54|0.7241
71839601|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|29.04||0.5195|TWO_SIDED|80.0|-68.69|26.43||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||26.43|-68.69|0.5195
71673339|NCT01790984|142864561|OTHER||General linear mixed model|10.0|||>|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables|Details of our statistical analyses are described below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||>0.05
71673340|NCT01790984|142864562|OTHER||General linear mixed model|0.28|||<|0.05|TWO_SIDED|||||Outcome measures were analysed as dependent variables in a general linear mixed model. All outcome variables in the model analysed were part of an priori hypothesis, and for this reason were not subject to adjustment for multiple comparisons.|Mixed Models Analysis|Mixed model analysis was appropriate for testing the impact of 'Diet' (high and low sugar) and Group (NAFLD and Control) status on outcome variables.|Details of our statistical analyses are given below.|The sample size of the NAFDL \& Control groups was based on primary outcome measures for a trace-labelling study of VLDL kinetics (VLDL1 apo B \& TAG production rates). From the literature there was an 80% probability that our study will detect a difference in the production rates of VLDL1 apo B of 30% (α=39%), and 26% for VLDL1-TG (α=33%). A paired comparison of two diets (5% level), gave sample sizes of n=15 for each group. Note: All reported P-values were calculated.|For outcome measures for which there were four samples from each participant (pre- and post-diets, for each period), the post-diet measurements were analysed as dependent variables in a general linear mixed model, with the following fixed categorical, non-random, explanatory effects: period, treatment (low and high sugar diet), period by treatment interaction (to detect carry-over effects), liver fat level (NAFLD and Control) and treatment by liver fat level interaction. The pre-diet measurements for each period, and bodyweights (pre- and post-diets) were included as covariates in the model, with participant as a model random effect. For outcome measures for which there were two samples for each participant (post-diets; end of each dietary intervention period only), each measurement for the combined groups (NAFLD and controls), for the 2-period cross-over, were analysed in a general linear mixed model with the same fixed categorical effects and bodyweights as covariates.|||<0.05
71673341|NCT00375973|142864585|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Regression, Linear|||||||0.23
71794673|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.9091|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9091
71794674|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794675|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.7718|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7718
71794676|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|2.11|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794677|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-10.1|STANDARD_ERROR_OF_MEAN|3.5||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
71794678|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839602|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|11.3|STANDARD_ERROR_OF_MEAN|8.27||0.1869|TWO_SIDED|80.0|0.34|22.26||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||22.26|0.34|0.1869
71839603|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-87.5|STANDARD_ERROR_OF_MEAN|55.3||0.2545|TWO_SIDED|80.0|-191.75|16.79||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||16.79|-191.75|0.2545
71839604|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-20.2|STANDARD_ERROR_OF_MEAN|10.26||0.0643|TWO_SIDED|80.0|-33.88|-6.57||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 4||-6.57|-33.88|0.0643
71794679|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.272|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2720
71839605|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|20.11||0.2503|TWO_SIDED|80.0|-61.52|4.35||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||4.35|-61.52|0.2503
71839606|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|11.58||0.8468|TWO_SIDED|80.0|-13.08|17.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||17.62|-13.08|0.8468
71839607|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-83.6|STANDARD_ERROR_OF_MEAN|73.93||0.3755|TWO_SIDED|80.0|-222.98|55.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||55.18|-222.98|0.3755
71839608|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-20.9|STANDARD_ERROR_OF_MEAN|11.06||0.0755|TWO_SIDED|80.0|-35.58|-6.15||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 8||-6.15|-35.58|0.0755
71839609|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-28.6|STANDARD_ERROR_OF_MEAN|25.77||0.3486|TWO_SIDED|80.0|-70.76|13.65||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||13.65|-70.76|0.3486
71839610|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|9.69||0.6559|TWO_SIDED|80.0|-17.28|8.5||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||8.50|-17.28|0.6559
71839611|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-70.2|STANDARD_ERROR_OF_MEAN|50.46||0.2987|TWO_SIDED|80.0|-165.35|24.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||24.94|-165.35|0.2987
71839612|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|12.43||0.1966|TWO_SIDED|80.0|-33.29|-0.13||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 12||-0.13|-33.29|0.1966
71839613|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-41.5|STANDARD_ERROR_OF_MEAN|25.7||0.2051|TWO_SIDED|80.0|-83.56|0.62||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||0.62|-83.56|0.2051
71839614|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|10.16||0.7511|TWO_SIDED|80.0|-16.79|10.25||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||10.25|-16.79|0.7511
71839615|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-79.6|STANDARD_DEVIATION|39.27||0.1797|TWO_SIDED|80.0|-153.68|-5.59||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-5.59|-153.68|0.1797
71839616|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|11.45||0.1715|TWO_SIDED|80.0|-31.61|-1.08||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 16||-1.08|-31.61|0.1715
71839617|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-36.5|STANDARD_ERROR_OF_MEAN|21.32||0.185|TWO_SIDED|80.0|-71.47|-1.63||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-1.63|-71.47|0.1850
71839618|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|12.19||0.6907|TWO_SIDED|80.0|-21.15|11.29||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||11.29|-21.15|0.6907
71839619|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-74.0|STANDARD_ERROR_OF_MEAN|23.85||0.0901|TWO_SIDED|80.0|-118.97|-29.02||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||-29.02|-118.97|0.0901
71839620|NCT03858634|143187359|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|13.34||0.564|TWO_SIDED|80.0|-25.64|9.94||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||Change at Week 18||9.94|-25.64|0.5640
71839621|NCT03858634|143187360|SUPERIORITY||LS mean difference|-31.7|STANDARD_ERROR_OF_MEAN|38.73||0.4734|TWO_SIDED|80.0|-95.11|31.76||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||31.76|-95.11|0.4734
71839622|NCT03858634|143187360|SUPERIORITY||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|14.91||0.813|TWO_SIDED|80.0|-23.33|16.18||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||16.18|-23.33|0.8130
71839623|NCT03858634|143187360|SUPERIORITY||LS mean difference|-92.0|STANDARD_ERROR_OF_MEAN|31.1||0.0979|TWO_SIDED|80.0|-150.6|-33.32||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-33.32|-150.60|0.0979
71839624|NCT03858634|143187360|SUPERIORITY||LS mean difference|-37.5|STANDARD_ERROR_OF_MEAN|13.48||0.0122|TWO_SIDED|80.0|-55.48|-19.61||Calculated from an ANCOVA model including treatment as factor and baseline values as covariate.|ANCOVA|||||-19.61|-55.48|0.0122
71839625|NCT03808818|143187363|EQUIVALENCE|the smallest detectable difference will be 22%|Odds Ratio (OR)|2.3||||0.0046|TWO_SIDED|95.0|1.28|4.13||No correction for multiple comparisons|Chi-squared|||"For self-reported 7-day point prevalence abstinence at 6-months, with a sample size of 140 in each arm then smallest detectable difference will be 22% with 80% power. Subsequent analyses will use a Bonferroni corrected alpha of 0.002 using with an estimated control rate of 31%.~The primary analysis will be performed from an intent-to-treat perspective. Chi-square tests will be used to compare the outcomes between treatment groups."||4.13|1.28|0.0046
71794680|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794681|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.4767|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4767
71794682|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-4.5|STANDARD_ERROR_OF_MEAN|2.32||0.0553|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0553
71794683|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-6.9|STANDARD_ERROR_OF_MEAN|3.73||0.0632|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0632
71794684|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794685|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.9398|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9398
71794686|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71673342|NCT00375973|142864586|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
71794687|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.5655|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5655
71794688|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.54||0.0204|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0204
71794689|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|4.37||0.1414|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1414
71839626|NCT03808818|143187364|EQUIVALENCE|the smallest detectable difference will be 22% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 28%.|Odds Ratio (OR)|1.86||||0.035|TWO_SIDED|95.0|1.04|3.33|||Chi-squared|||7-day point prevalence abstinence at 3-months, with a sample size of 140 in each arm then smallest detectable difference will be 18% with 80% power and a Bonferroni corrected alpha of 0.002 using and an estimated control rate of 20%||3.33|1.04|0.035
71839627|NCT03808818|143187365|EQUIVALENCE|the smallest detectable difference will be 21% with 80% power and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%.||||||0.016|||||||Chi-squared|||power calculations assumed a sample size of 140 in each arm and a Bonferroni corrected alpha of 0.002 and an estimated control rate of 20%||||0.016
71839628|NCT03808818|143187367|EQUIVALENCE|no margin||||||0.069|||||||Chi-squared|||||||0.069
71839629|NCT03808818|143187368|EQUIVALENCE|no margin||||||0.86|||||||Chi-squared|||||||0.86
71673343|NCT00375973|142864587|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Regression, Linear|||||||0.67
71673344|NCT00375973|142864588|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
71673345|NCT00375973|142864589|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
71673346|NCT00375973|142864590|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Fisher Exact|||||||0.02
71673347|NCT00375973|142864591|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Fisher Exact|||||||0.24
71673348|NCT01691560|142864614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.4553|TWO_SIDED|95.0|-0.14|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.14|0.4553
71673349|NCT01691560|142864614|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07||||0.5689|TWO_SIDED|95.0|-0.16|0.3|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.30|-0.16|0.5689
71673350|NCT01691560|142864614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.7517|TWO_SIDED|95.0|-0.2|0.27|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.27|-0.20|0.7517
71794690|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794691|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.6279|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6279
71794692|NCT01480076|143086486|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794693|NCT01480076|143086486|SUPERIORITY_OR_OTHER|||||||0.2239|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2239
71794694|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-7.5|STANDARD_ERROR_OF_MEAN|2.67||0.0049|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0049
71794695|NCT01480076|143086486|SUPERIORITY_OR_OTHER||difference of LS means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3457|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3457
71794696|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794697|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.2087|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2087
71794698|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892955|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
71892956|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
71892957|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
71677313|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|111.12|||<|0.001||95.0|76.3|145.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||145.9|76.3|<0.001
71839630|NCT03808818|143187380|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
71673351|NCT01691560|142864614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.8549|TWO_SIDED|95.0|-0.21|0.25|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.25|-0.21|0.8549
71794699|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.4487|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4487
71839631|NCT03808818|143187381|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
71839632|NCT03808818|143187382|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
71839633|NCT03808818|143187384|EQUIVALENCE|No equivalence margin|||||<|0.0001||||||Alpha level 0.01|Fisher Exact|||Fisher's exact tests were performed to assess the differences between the VST and EUC arms on the 6-month questionnaire.||||<.0001
71839634|NCT03150173|143187431|SUPERIORITY|||||||0.94|||||||Chi-squared|||||||0.94
71839635|NCT02547363|143187455|SUPERIORITY||||||<|0.001|||||||Fisher exact test|||||||<0.001
71839636|NCT02547363|143187456|SUPERIORITY||Ratio of clearance rates|62.59|||<|0.001|TWO_SIDED|95.0|8.68|451.08|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||451.08|8.68|<0.001
71839637|NCT02547363|143187457|SUPERIORITY||Ratio of clearance rates|59.21|||<|0.001|TWO_SIDED|95.0|8.44|415.35|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||415.35|8.44|<0.001
71839638|NCT02547363|143187458|SUPERIORITY||Week 8 AK count ratio|0.27|||<|0.001|TWO_SIDED|95.0|0.23|0.32|||Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.23|<0.001
71839639|NCT05977530|143187542|SUPERIORITY||comparison of ranks in Wilcoxon|0.0|||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.01
71794700|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-2.1|STANDARD_ERROR_OF_MEAN|0.64||0.0013|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0013
71794701|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.15||0.0188|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0188
71794702|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794703|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.4243|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4243
71794704|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839640|NCT05692960|143187546|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|FSFI Total, HRI Cohen's d|1.37|||||TWO_SIDED|95.0|0.62|2.1||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for FSFI total, FSFI lubrication, FSFI pain, and FSFI desire subscales. Means and 95% confidence intervals were also calculated.||2.10|.62|
71839641|NCT05692960|143187546|SUPERIORITY||FSFI Total, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.86|2.37||||||||2.37|.86|
71839642|NCT05692960|143187546|SUPERIORITY||FSFI Lubrication, HRI Cohen's d|1.2|||||TWO_SIDED|95.0|0.49|1.87||||||||1.87|.49|
71839643|NCT05692960|143187546|SUPERIORITY||FSFI Lubrication, VVA Cohen's d|1.85|||||TWO_SIDED|95.0|1.02|2.66||||||||2.66|1.02|
71839644|NCT05692960|143187546|SUPERIORITY||FSFI Pain, HRI Cohen's d|0.77|||||TWO_SIDED|95.0|0.16|1.36||||||||1.36|.16|
71794705|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.9989|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9989
71794706|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-1.6|STANDARD_ERROR_OF_MEAN|0.68||0.0207|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0207
71794707|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-2.9|STANDARD_ERROR_OF_MEAN|1.18||0.0161|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0161
71794708|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794709|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.4256|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4256
71794710|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794711|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.3313|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3313
71794712|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|0.83||0.0238|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0238
71794713|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.015|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0150
71673352|NCT01691560|142864614|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05||||0.6685|TWO_SIDED|95.0|-0.18|0.29|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-0.18|0.6685
71794714|NCT01480076|143086487|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794715|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.0171|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0171
71839645|NCT05692960|143187546|SUPERIORITY||FSFI Pain, VVA Cohen's d|0.82|||||TWO_SIDED|95.0|0.24|1.38||||||||1.38|.24|
71839646|NCT05692960|143187546|SUPERIORITY||FSFI Desire, HRI Cohen's d|1.15|||||TWO_SIDED|95.0|0.46|1.82||||||||1.82|.46|
71839647|NCT05692960|143187546|SUPERIORITY||FSFI Desire, VVA Cohen's d|1.21|||||TWO_SIDED|95.0|0.55|1.86||||||||1.86|.55|
71839648|NCT05692960|143187547|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|BITS, HRI Cohen's d|1.0|||||TWO_SIDED|95.0|0.34|1.63||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-tests for the BITS. Means and 95% confidence intervals were also calculated.||1.63|.34|
71839649|NCT05692960|143187547|SUPERIORITY||BITS, VVA Cohen's d|0.5|||||TWO_SIDED|95.0|0.03|1.01||||||||1.01|.03|
71892958|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.51|-0.45|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.51|<0.001
71673353|NCT01691560|142864614|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03||||0.8031|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA||Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.26|0.8031
71673354|NCT01691560|142864615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0467|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0467
71794716|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.0007|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0007
71794717|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.5146|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5146
71794718|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-3.0|STANDARD_ERROR_OF_MEAN|0.84||0.0003|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0003
71794719|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.1224|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1224
71794720|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.0168|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0168
71794721|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.2272|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2272
71794722|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.057|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0570
71839650|NCT05692960|143187548|SUPERIORITY|For this feasibility study, a sample of approximately 15 participants per arm will allow for estimates that can be used in the development of a larger study.|PROMIS Interest, HRI Cohen's d|1.1|||||TWO_SIDED|95.0|0.41|1.75||||||Effect sizes, Cohen's d, were calculated for both study arms using paired t-test for PROMIS interest, lubrication and satisfaction subscales. Means and 95% confidence intervals were also calculated.||1.75|.41|
71794723|NCT01480076|143086487|SUPERIORITY_OR_OTHER|||||||0.5832|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5832
71794724|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|0.94||0.0561|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0561
71794725|NCT01480076|143086487|SUPERIORITY_OR_OTHER||difference of LS means|-1.9|STANDARD_ERROR_OF_MEAN|1.86||0.2971|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2971
71839651|NCT05692960|143187548|SUPERIORITY||PROMIS Interest, VVA Cohen's d|0.64|||||TWO_SIDED|95.0|0.09|1.18||||||||1.18|.09|
71839652|NCT05692960|143187548|SUPERIORITY||PROMIS Satisfaction, HRI Cohen's d|1.19|||||TWO_SIDED|95.0|0.45|1.89||||||||1.89|.45|
71839653|NCT05692960|143187548|SUPERIORITY||PROMIS Satisfaction, VVA Cohen's d|0.8|||||TWO_SIDED|95.0|0.13|1.44||||||||1.44|.13|
71673355|NCT01691560|142864615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1133|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1133
71673356|NCT01691560|142864615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2579||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.2579
71673357|NCT01691560|142864615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.6149|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.6149
71794726|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794727|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.0029|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0029
71794728|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794729|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.8041|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8041
71794730|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|11.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839654|NCT05692960|143187548|SUPERIORITY||PROMIS Lubrication, HRI Cohen's d|1.79|||||TWO_SIDED|95.0|0.88|2.67||||||||2.67|.88|
71839655|NCT05692960|143187548|SUPERIORITY||PROMIS Lubrication, VVA Cohen's d|1.63|||||TWO_SIDED|95.0|0.74|2.5||||||||2.50|.74|
71673358|NCT01691560|142864615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3259|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.3259
71794731|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|9.4|STANDARD_ERROR_OF_MEAN|3.1||0.0026|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0026
71794732|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794733|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.0689|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0689
71794734|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839656|NCT04382664|143187549|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.845|TWO_SIDED|80.0|0.694|1.309|||Regression, Cox|||||1.309|0.694|0.845
71892959|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.38|-0.32|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.38|0.002
71892960|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.76|-0.7|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.70|-1.76|<0.001
71892961|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.35|-0.3|||ANCOVA|||Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.35|0.002
71794735|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.7182|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7182
71794736|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794737|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|9.8|STANDARD_ERROR_OF_MEAN|3.57||0.0061|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0061
71794738|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794739|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.0179|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0179
71794740|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839657|NCT05239455|143187594|OTHER|The FDA requires one-sided 95% lower confidence limit for the population proportion of success is greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75%. Allows for low recoveries (\<75%) in 2/20 or 3/24 volunteers.|95% Confidence Interval|88.5|||||ONE_SIDED|95.0|72.81||||||A one-sided confidence interval for the proportion of successes was determined using the Clopper-Pearson exact method for a 95% confidence interval.|The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Proportion of successes greater than 70% where success of a unit is defined as the RBC in vivo 24-hour percentage recovery ≥ 75% was calculated.||72.81|
71794741|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.6911|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6911
71794742|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|2.31|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794743|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|7.1|STANDARD_ERROR_OF_MEAN|3.85||0.0666|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0666
71794744|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71673359|NCT01691560|142864615|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5721|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|0|0.5721
71673360|NCT01691560|142864616|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.36||||0.0292|TWO_SIDED|95.0|0.04|0.69|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.69|0.04|0.0292
71673361|NCT01691560|142864616|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4484|TWO_SIDED|95.0|-0.44|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.44|0.4484
71673362|NCT01691560|142864616|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.12||||0.4537|TWO_SIDED|95.0|-0.45|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.20|-0.45|0.4537
71794745|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.0158|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
71794746|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794747|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.6684|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6684
71794748|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|11.6|STANDARD_ERROR_OF_MEAN|2.49|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794749|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|10.5|STANDARD_ERROR_OF_MEAN|4.28||0.0141|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
71794750|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839658|NCT05239455|143187595|OTHER|The FDA criteria requires LR-RBC mean 24-hour recovery ≥ 75% with standard deviation (SD) ≤ 9%||||||||||||||||The comparison is to the FDA requirements for in vivo 24-hour recovery of LR-RBC.|Mean and standard deviation were calculated.|||
71794751|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.0042|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0042
71794752|NCT01480076|143086488|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794753|NCT01480076|143086488|SUPERIORITY_OR_OTHER|||||||0.7329|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7329
71892962|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|95.0|-1.39|-0.34|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.34|-1.39|0.001
71892963|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.94|-0.9|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.94|<0.001
71839659|NCT01799265|143187596|NON_INFERIORITY|The 95% upper limit of the prediction interval was calculated using the formula (μ ) ̂+t\_(k-2)\^α √((τ\^2 ) ̂+〖(SE) ̂(μ ̂ )〗\^2 ),where (μ ) ̂is the estimate average AHI across all studies, (τ\^2 ) ̂ is the between-study variation, t\_(k-2)\^α is the critical value for a t-distribution, k is the number of studies in the meta-analysis, and k-2 are the degrees of freedom for the t distribution. Meta-analyzed statistics to compute the prediction interval were (μ ) ̂=5.0, SE(μ ̂ )=0.9, and (τ\^2 ) ̂=8.0||||||0.05|||||||t-test, 1 sided|A p-value of .05 was used.||"Hypothesis testing for the primary endpoint was conducted using a one-sided test of non-inferiority with the following null and alternative hypotheses at the 0.05 significance level using the MIXED procedure in SAS, version 9.3:~H\_0:(ϕ\_m ) ̂≥6.9 H\_A:(ϕ\_m ) ̂\<6.9 where (ϕ\_m ) ̂ is the estimated AHI difference between Transcend Auto and REMstar Auto from the model described in 3.5.1."||||.05
71839660|NCT02364557|143187623|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|70.0|0.71|1.17||One-side significance level = 0.15|Log Rank||Reference level = SOC arm|Assuming an increase in median PFS from 10.5 to 19 months (HR: 0.55), 69 events provide \>90% power to conclude superiority with 1-sided α = 0.15.||1.17|0.71|0.36
71839661|NCT02364557|143187626|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.91|TWO_SIDED|95.0|0.59|1.61||Two-sided significance level = 0.05|Gray's test||Reference level = SOC arm|||1.61|0.59|0.91
71839662|NCT02364557|143187628|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9|TWO_SIDED|95.0|0.54|2.02||Two-sided significance level = 0.05.|Log Rank||Reference level = CTCs Absent|||2.02|0.54|0.90
71839663|NCT04828005|143187651|NON_INFERIORITY|Alternative hypothesis: Nalmefene reversal not less than 80% naloxone reversal|||||<|0.0009|||||||Mixed Models Analysis|||||||<0.0009
71673363|NCT01691560|142864616|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49||||0.0037|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0037
71794754|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|13.2|STANDARD_ERROR_OF_MEAN|2.65|<|0.0001|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839664|NCT03381196|143187659|SUPERIORITY|||||||0.0216|||||||Gehan-Wilcoxon test|||||||0.0216
71839665|NCT03904147|143187780|SUPERIORITY||Win Ratio|1.44||||0.0311|TWO_SIDED||||||Finkelstein-Schoenfeld Method||The Win Ratio provides an estimation of the treatment effect.|||||0.0311
71839666|NCT03904147|143187781|SUPERIORITY|||||||0.0008|||||||exact test|||||||0.0008
71839667|NCT03904147|143187782|SUPERIORITY||||||<|0.0001|||||||Z test|||||||<0.0001
71839668|NCT03904147|143187783|SUPERIORITY||||||<|0.0001|||||||ANCOVA model|||||||<0.0001
71839669|NCT03904147|143187784|SUPERIORITY||||||<|0.0001|||||||Chi-square test|||||||<0.0001
71839670|NCT03904147|143187785|SUPERIORITY|||||||0.2482|||||||ANCOVA model|||||||0.2482
71839671|NCT03904147|143187786|SUPERIORITY||||||<|0.0001|||||||Exact test|||||||<0.0001
71839672|NCT03904147|143187787|SUPERIORITY||||||<|0.0001|||||||Binomial exact method|||||||<0.0001
71839673|NCT03904147|143187788|SUPERIORITY|||||||0.109|||||||normal approximation|||||||0.1090
71839674|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|-1.29||||0.27|TWO_SIDED|95.0|-3.6|1.03|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||1.03|-3.60|0.27
71677314|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.21|||<|0.001|TWO_SIDED|95.0|89.2|159.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours||159.2|89.2|<0.001
71839675|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|-0.25||||0.83|TWO_SIDED|95.0|-2.53|2.04|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||2.04|-2.53|0.83
71839676|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|-2.01||||0.08|TWO_SIDED|95.0|-4.3|0.28|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.28|-4.30|0.08
71839677|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|-1.56||||0.16|TWO_SIDED|95.0|-3.77|0.65|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.65|-3.77|0.16
71839678|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|-1.65||||0.14|TWO_SIDED|95.0|-3.84|0.54|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||0.54|-3.84|0.14
71839679|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|-2.46||||0.04|TWO_SIDED|95.0|-4.47|-0.17|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.||-0.17|-4.47|0.04
71839680|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|2.46||||0.04|TWO_SIDED|95.0|0.17|4.74|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.74|0.17|0.04
71839681|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|1.17||||0.32|TWO_SIDED|95.0|-1.14|3.48|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.48|-1.14|0.32
71839682|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|2.21||||0.06|TWO_SIDED|95.0|-0.08|4.5|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||4.50|-0.08|0.06
71839683|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|0.45||||0.7|TWO_SIDED|95.0|-1.84|2.73|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||2.73|-1.84|0.70
71839684|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|0.9||||0.42|TWO_SIDED|95.0|-1.31|3.1|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.10|-1.31|0.42
71839685|NCT01037881|143187791|SUPERIORITY||Difference in least squares mean|0.81||||0.47|TWO_SIDED|95.0|-1.38|3.0|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.||3.00|-1.38|0.47
71839686|NCT00764751|143187797|SUPERIORITY||Mean Difference (Final Values)|15.4|||=|0.003|TWO_SIDED|95.0|5.6|25.0|||Paired t-test|||||25|5.6|=0.003
71794755|NCT01480076|143086488|SUPERIORITY_OR_OTHER||difference of LS means|10.1|STANDARD_ERROR_OF_MEAN|4.49||0.0242|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0242
71794756|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
71794757|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.9151|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9151
71794758|NCT01480076|143086489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794759|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.6128|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6128
71794760|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0331|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0331
71794761|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1919|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1919
71794762|NCT01480076|143086489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794763|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.4481|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4481
71794764|NCT01480076|143086489|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794765|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.5454|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5454
71673364|NCT01691560|142864616|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.48||||0.004|TWO_SIDED|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.81|0.16|0.0040
71673365|NCT01691560|142864616|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9974|TWO_SIDED|95.0|-0.32|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.32|-0.32|0.9974
71839687|NCT00764751|143187797|SUPERIORITY||Mean Difference (Final Values)|-17.1||||0.07|TWO_SIDED|95.0|-36.0|1.9|||Paired t-test|||||1.9|-36.0|0.07
71673366|NCT01691560|142864617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8861|TWO_SIDED|95.0|-5.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|-5|0.8861
71673367|NCT01691560|142864617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0641|TWO_SIDED|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.0641
71673368|NCT01691560|142864617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1831||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||5|0|0.1831
71673369|NCT01691560|142864617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0871|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.0871
71673370|NCT01691560|142864617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.169|TWO_SIDED|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-10|0.1690
71794766|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.0516|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0516
71794767|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.09|STANDARD_ERROR_OF_MEAN|0.04||0.0175|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0175
71794768|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0001
71794769|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.9371|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9371
71794770|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
71794771|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.5475|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5475
71673371|NCT01691560|142864617|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3829|TWO_SIDED|95.0|-5.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0|-5|0.3829
71839688|NCT04563546|143187806|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
71839689|NCT04563546|143187807|OTHER|||||||0.739|||||||Chi-squared|||||||0.739
71794772|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.0699|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0699
71839690|NCT04563546|143187808|OTHER||||||<|0.001||||||Unadjusted p-value. Threshold for statistical significance = 0.05|Chi-squared|||||||<0.001
71839691|NCT04413708|143187867|SUPERIORITY||Risk Ratio (RR)|1.62||||0.41|TWO_SIDED|95.0|0.5|5.17|||Fisher Exact|||||5.17|0.50|0.41
71839692|NCT04413708|143187868|SUPERIORITY||Risk Ratio (RR)|1.07||||1|TWO_SIDED|95.0|0.61|1.9|||Fisher Exact|||||1.90|0.61|1.0
71892964|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.7|-0.58|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.70|<0.001
71794773|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.587|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5870
71794774|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
71794775|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.9926|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9926
71794776|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0027|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0027
71794777|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.6368|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6368
71892965|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.57|-0.45|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.45|-1.57|<0.001
71892966|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.35|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.91|-0.79|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.79|-1.91|<0.001
71892967|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.29||0.021|TWO_SIDED|95.0|-1.26|-0.1|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-1.26|0.021
71892968|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.29||0.029|TWO_SIDED|95.0|-1.22|-0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.07|-1.22|0.029
71892969|NCT00733902|143307153|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.78|-0.62|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.62|-1.78|<0.001
71892970|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.27||0.044|TWO_SIDED|95.0|-1.07|-0.02|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-1.07|0.044
71892971|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.875|TWO_SIDED|95.0|-0.57|0.48|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.48|-0.57|0.875
71892972|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.129|TWO_SIDED|95.0|-0.93|0.12|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.12|-0.93|0.129
71892973|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.46|-0.41|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.46|<0.001
71892974|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||L Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.27||0.004|TWO_SIDED|95.0|-1.28|-0.24|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-1.28|0.004
71892975|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.71|-0.67|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.71|<0.001
71892976|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.26||0.002|TWO_SIDED|95.0|-1.33|-0.3|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-1.33|0.002
71892977|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.46|-0.43|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.43|-1.46|<0.001
71892978|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.04|-1.02|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-1.02|-2.04|<0.001
71892979|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.56|-0.51|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.56|<0.001
71794778|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3358|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3358
71794779|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5089|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5089
71794780|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0141|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0141
71794781|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.428|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4280
71794782|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.0002|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0002
71794783|NCT01480076|143086489|SUPERIORITY_OR_OTHER|||||||0.3827|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3827
71794784|NCT01480076|143086489|SUPERIORITY_OR_OTHER||difference of LS means|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0748|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0748
71892980|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-1.52|<0.001
71673372|NCT01691560|142864618|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.9421|TWO_SIDED|95.0|-0.74|0.8|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.80|-0.74|0.9421
71673373|NCT01691560|142864618|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.15||||0.6918|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.60|-0.90|0.6918
71677315|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|178.91|||<|0.001|TWO_SIDED|95.0|122.4|235.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||235.4|122.4|<0.001
71794785|NCT01480076|143086489|SUPERIORITY_OR_OTHER||least squares mean|0.03|STANDARD_ERROR_OF_MEAN|0.05||0.5663|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5663
71794786|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.1544|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1544
71794787|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.0167|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0167
71892981|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.85|-1.90|<0.001
71794788|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.3868|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3868
71794789|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.2214|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2214
71794790|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|8.9|STANDARD_ERROR_OF_MEAN|4.96||0.0743|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0743
71794791|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|-17.2|STANDARD_ERROR_OF_MEAN|12.22||0.1601|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1601
71794792|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.1251|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1251
71794793|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.1764|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1764
71794794|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.5528|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5528
71794795|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.108|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1080
71794796|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|4.6|STANDARD_ERROR_OF_MEAN|6.27||0.4644|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4644
71794797|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|-30.6|STANDARD_ERROR_OF_MEAN|17.91||0.0887|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0887
71794798|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.0071|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0071
71839693|NCT03133546|143187869|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.84|TWO_SIDED|95.0|0.68|1.37||significance level: 5%|Regression, Cox|Univariate Cox for PFS with treatment effect only|The HR for Osimertinib plus Bevacizumab versus Osimertinib alone is provided.|"Assumption: Median PFS with osimertinib 11 months Target: Detect a 36% improvement in PFS (HR=0.64, corresponding to an increase in median PFS to 17.2 months) under osimertinib and bevacizumab (80% power, at one-sided significant level of 5%)~126 events required"||1.37|0.68|0.84
71673374|NCT01691560|142864618|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.13||||0.7421|TWO_SIDED|95.0|-0.63|0.88|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.88|-0.63|0.7421
71673375|NCT01691560|142864618|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18||||0.6433|TWO_SIDED|95.0|-0.58|0.94|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.94|-0.58|0.6433
71673376|NCT01691560|142864618|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.1||||0.801|TWO_SIDED|95.0|-0.86|0.67|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.67|-0.86|0.8010
71673377|NCT01691560|142864618|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28||||0.4692|TWO_SIDED|95.0|-0.48|1.03|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.03|-0.48|0.4692
71673378|NCT01691560|142864619|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.31||||0.4797|TWO_SIDED|95.0|-0.55|1.16|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.16|-0.55|0.4797
71673379|NCT01691560|142864619|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.54||||0.2023|TWO_SIDED|95.0|-1.37|0.29|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.29|-1.37|0.2023
71673380|NCT01691560|142864619|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45||||0.2917|TWO_SIDED|95.0|-1.29|0.39|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.39|-1.29|0.2917
71673381|NCT01691560|142864619|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.85||||0.0503|TWO_SIDED|95.0|0.0|1.69|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.69|0.00|0.0503
71794799|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.064|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0640
71794800|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.1552|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1552
71794801|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.5979|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5979
71673382|NCT01691560|142864619|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.76||||0.0811|TWO_SIDED|95.0|-0.09|1.61|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||1.61|-0.09|0.0811
71673383|NCT01691560|142864619|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09||||0.8322|TWO_SIDED|95.0|-0.75|0.93|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.||0.93|-0.75|0.8322
71673384|NCT01511978|142864838|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71673385|NCT01511978|142864839|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71677316|NCT01516008|142873164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|192.05|||<|0.001|TWO_SIDED|95.0|135.2|248.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours||248.9|135.2|<0.001
71677317|NCT01516008|142873165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
71839694|NCT03468868|143187875|NON_INFERIORITY|We chose a non-inferiority margin of 10% (or 0.10 feet per second) for this population.|Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|1.1|<|0.01|TWO_SIDED|95.0|-0.14|0.44|||t-test, 2 sided|||||0.44|-0.14|<0.01
71794802|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|4.3|STANDARD_ERROR_OF_MEAN|5.58||0.4444|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4444
71794803|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|-10.7|STANDARD_ERROR_OF_MEAN|12.27||0.3863|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3863
71794804|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.6352|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6352
71794805|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.1265|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1265
71794806|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.6161|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6161
71794807|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.528|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5280
71794808|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|11.5|STANDARD_ERROR_OF_MEAN|8.51||0.1769|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1769
71794809|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|-16.0|STANDARD_ERROR_OF_MEAN|22.24||0.4743|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4743
71794810|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.6901|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6901
71839695|NCT03468868|143187876|SUPERIORITY||Mean Difference (Final Values)|72.46|STANDARD_DEVIATION|384.1||0.16|TWO_SIDED|95.0|-29.56|174.5|||t-test, 2 sided|||||174.5|-29.56|0.16
71839696|NCT03468868|143187877|SUPERIORITY||Mean Difference (Final Values)|-4.71|STANDARD_DEVIATION|24.96||0.13|TWO_SIDED|95.0|-10.84|1.41|||t-test, 2 sided|||||1.41|-10.84|0.13
71839697|NCT03468868|143187878|SUPERIORITY||Mean Difference (Final Values)|0.88|STANDARD_DEVIATION|18.22||0.7|TWO_SIDED|95.0|-3.55|5.32|||t-test, 2 sided|||||5.32|-3.55|0.70
71839698|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|6.71||0.43|TWO_SIDED|95.0|-0.97|2.3|||t-test, 2 sided|||NeuroQOL Anxiety Domain||2.30|-0.97|0.43
71839699|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|6.16||0.75|TWO_SIDED|95.0|-1.26|1.74|||t-test, 2 sided|||NeuroQOL Depression Domain||1.74|-1.26|0.75
71839700|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|7.54||0.35|TWO_SIDED|95.0|-2.71|0.97|||t-test, 2 sided|||NeuroQOL Fatigue Domain||0.97|-2.71|0.35
71839701|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|3.83||0.91|TWO_SIDED|95.0|-0.88|0.99|||t-test, 2 sided|||NeuroQOL Upper Extremity Function Domain||0.99|-0.88|0.91
71794811|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.0245|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0245
71794812|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.7707|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7707
71794813|NCT01480076|143086490|SUPERIORITY_OR_OTHER|||||||0.4989|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4989
71794814|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|15.2|STANDARD_ERROR_OF_MEAN|7.31||0.0387|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0387
71794815|NCT01480076|143086490|SUPERIORITY_OR_OTHER||difference of LS means|-11.7|STANDARD_ERROR_OF_MEAN|15.88||0.4635|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4635
71794816|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.1392|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1392
71794817|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.1448|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1448
71839702|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|1.52|STANDARD_DEVIATION|5.44||0.02|TWO_SIDED|95.0|0.2|2.85|||t-test, 2 sided|||NeuroQOL Lower Extremity Function Domain||2.85|0.20|0.02
71839703|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|-0.89||||0.29|TWO_SIDED|95.0|-2.54|0.76|||t-test, 2 sided|||NeuroQOL Cognitive Function Domain||0.76|-2.54|0.29
71839704|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|1.08||||0.11|TWO_SIDED|95.0|-0.26|2.42|||t-test, 2 sided|||NeuroQOL Emotional and Behavioral Dyscontrol Domain||2.42|-0.26|0.11
71794818|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.0187|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0187
71794819|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.292|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2920
71794820|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|4.2|STANDARD_ERROR_OF_MEAN|4.95||0.3968|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3968
71794821|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|10.95||0.642|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6420
71839705|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_DEVIATION|7.13||0.54|TWO_SIDED|95.0|-1.19|2.28|||t-test, 2 sided|||NeuroQOL Positive Affect and Well-Being Domain||2.28|-1.19|0.54
71839706|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_DEVIATION|5.76||0.41|TWO_SIDED|95.0|-2.0|0.81|||t-test, 2 sided|||NeuroQOL Sleep Disturbance Domain||0.81|-2.00|0.41
71677318|NCT01516008|142873165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||||||<0.001
71794822|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.01|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0100
71892982|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.27||0.03|TWO_SIDED|95.0|-1.12|-0.06|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-1.12|0.030
71794823|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.8634|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8634
71794824|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.0134|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0134
71892983|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.27||0.002|TWO_SIDED|95.0|-1.39|-0.32|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.32|-1.39|0.002
71892984|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.96|-0.9|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.90|-1.96|<0.001
71892985|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.28||0.085|TWO_SIDED|95.0|-1.03|0.07|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.07|-1.03|0.085
71794825|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.8147|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8147
71794826|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|-5.1|STANDARD_ERROR_OF_MEAN|6.06||0.4035|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4035
71794827|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|-4.8|STANDARD_ERROR_OF_MEAN|14.25||0.7385|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7385
71794828|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.0139|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0139
71794829|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.5207|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5207
71794830|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.0091|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0091
71794831|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.2312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2312
71794832|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|-1.8|STANDARD_ERROR_OF_MEAN|5.89||0.7578|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7578
71794833|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|7.9|STANDARD_ERROR_OF_MEAN|13.42||0.5575|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5575
71892986|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.28||0.026|TWO_SIDED|95.0|-1.18|-0.08|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-1.18|0.026
71892987|NCT00733902|143307154|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.94|-0.84|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.84|-1.94|<0.001
71892988|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
71839707|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|6.65||0.63|TWO_SIDED|95.0|-1.22|2.02|||t-test, 2 sided|||NeuroQOL Ability to Participate in Social Roles and Activities Domain||2.02|-1.22|0.63
71839708|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|7.44||0.48|TWO_SIDED|95.0|-1.16|2.47|||t-test, 2 sided|||NeuroQOL Satisfaction with Social Roles and Activities Domain||2.47|-1.16|0.48
71839709|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|5.68||0.92|TWO_SIDED|95.0|-1.32|1.45|||t-test, 2 sided|||NeuroQOL Stigma Domain||1.45|-1.32|0.92
71839710|NCT03468868|143187879|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_DEVIATION|3.45||0.28|TWO_SIDED|95.0|-1.31|0.37|||t-test, 2 sided|||NeuroQOL Communication Domain||0.37|-1.31|0.28
71794834|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.4486|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4486
71794835|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.0102|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0102
71794836|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.1185|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1185
71794837|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.7523|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7523
71794838|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|17.1|STANDARD_ERROR_OF_MEAN|7.38||0.0214|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0214
71839711|NCT03468868|143187880|SUPERIORITY||Mean Difference (Final Values)|-2.48|STANDARD_DEVIATION|20.63||0.34|TWO_SIDED|95.0|-7.55|2.6|||t-test, 2 sided|||MSIS Physical||2.60|-7.55|0.34
71839712|NCT03468868|143187880|SUPERIORITY||Mean Difference (Final Values)|-1.38|STANDARD_DEVIATION|21.37||0.24|TWO_SIDED|95.0|-6.63|3.88|||t-test, 2 sided|||MSIS Psychological||3.88|-6.63|0.24
71839713|NCT03468868|143187881|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_DEVIATION|8.91||0.74|TWO_SIDED|95.0|-1.83|2.56|||t-test, 2 sided|||MFIS Cognitive||2.56|-1.83|0.74
71892989|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
71839714|NCT03468868|143187881|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|8.03||0.04|TWO_SIDED|95.0|-4.07|-0.12|||t-test, 2 sided|||MFIS Physical||-0.12|-4.07|0.04
71839715|NCT03468868|143187881|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|2.17||0.59|TWO_SIDED|95.0|-0.68|0.39|||t-test, 2 sided|||MFIS Psychosocial||0.39|-0.68|0.59
71839716|NCT03468868|143187881|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_DEVIATION|17.0||0.38|TWO_SIDED|95.0|-6.05|2.3|||t-test, 2 sided|||MFIS Total||2.30|-6.05|0.38
71839717|NCT03468868|143187882|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|1.18||0.87|TWO_SIDED|95.0|-0.34|0.29|||t-test, 2 sided|||||0.29|-0.34|0.87
71839718|NCT03468868|143187883|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_DEVIATION|2.21||0.05|TWO_SIDED|95.0|-1.08|0.0|||t-test, 2 sided|||||0.00|-1.08|0.05
71839719|NCT05399459|143187884|SUPERIORITY||Adjusted percentage difference|19.4|||<|0.0001|TWO_SIDED|95.0|12.0|26.8|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||26.8|12.0|<0.0001
71839720|NCT05399459|143187885|SUPERIORITY||Adjusted percentage difference|22.7|||<|0.0001|TWO_SIDED|95.0|14.5|30.9|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg - placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||30.9|14.5|<0.0001
71839721|NCT05399459|143187886|SUPERIORITY||Adjusted percentage difference|14.8||||0.0011|TWO_SIDED|95.0|5.9|23.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||23.6|5.9|0.0011
71892990|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
71892991|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.63|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.63|<0.001
71892992|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
71839722|NCT05399459|143187887|SUPERIORITY||Adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|10.1|27.4|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||27.4|10.1|<0.0001
71839723|NCT05399459|143187888|SUPERIORITY||Adjusted percentage difference|31.7|||<|0.0001|TWO_SIDED|95.0|23.2|40.3|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||40.3|23.2|<0.0001
71839724|NCT05399459|143187889|SUPERIORITY||Adjusted percentage difference|-19.7|||<|0.0001|TWO_SIDED|95.0|-27.8|-11.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||-11.6|-27.8|<0.0001
71839725|NCT05399459|143187890|SUPERIORITY||Adjusted percentage difference|33.1|||<|0.0001|TWO_SIDED|95.0|24.7|41.6|||Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||41.6|24.7|<0.0001
71839726|NCT05399459|143187891|SUPERIORITY||Adjusted percentage difference|10.1||||0.0707|TWO_SIDED|95.0|-0.9|21.1||P-value \> 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Mantel Haenszel||Adjusted percentage difference (rimegepant 75 mg- placebo) stratified by randomization stratum with Mantel-Haenszel weighting.|||21.1|-0.9|0.0707
71673386|NCT03020992|142864862|OTHER||Rate ratio|0.18|||<|0.001|TWO_SIDED|95.0|0.116|0.281|||Poisson regression|||"The Poisson regression allowed for a comparison of event rates adjusting for differences in time between prestudy/on-study periods.~Event rates were based on a Poisson model with generalized estimating equations and a log-link, including an offset term for time interval length, and with period and disease duration of axSpA (\<2 years/≥2 years) as covariates. A repeated statement was included for participants and assumed an exchangeable correlation structure between prestudy and on-study flares."||0.281|0.116|<0.001
71794839|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|0.4|STANDARD_ERROR_OF_MEAN|19.12||0.9826|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9826
71794840|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.6627|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6627
71794841|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.4674|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4674
71839727|NCT00986856|143187910|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|13.2|||<|0.01||95.0|1.4|120.4||Test for the hypothesis of odds ratio equal to 1.|Cochran-Mantel-Haenszel|||||120.4|1.4|<0.01
71839728|NCT00986856|143187911|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.7||||0.023||95.0|1.1|28.6|||Cochran-Mantel-Haenszel|||||28.6|1.1|0.023
71839729|NCT00986856|143187912|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7||||0.54|TWO_SIDED|95.0|0.3|8.1|||Cochran-Mantel-Haenszel|||||8.1|0.3|0.54
71839730|NCT00986856|143187913|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7||||0.1|TWO_SIDED|95.0|0.8|8.8|||Cochran-Mantel-Haenszel|||||8.8|0.8|0.1
71839731|NCT00986856|143187914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Cochran-Mantel-Haenszel|||||||0.1
71839732|NCT00986856|143187915|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.043||95.0|0.9|83.5|||Cochran-Mantel-Haenszel|||||83.5|0.9|0.043
71839733|NCT00986856|143187916|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.8||||0.007||95.0|1.5|109.6|||Cochran-Mantel-Haenszel|||||109.6|1.5|0.007
71839734|NCT00986856|143187917|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|2.0||0.008||95.0|-4.8|-0.8|||Regression, Linear|||||-0.8|-4.8|0.008
71794842|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.2965|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2965
71794843|NCT01480076|143086491|SUPERIORITY_OR_OTHER|||||||0.1778|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1778
71839735|NCT05583578|143187924|SUPERIORITY|||||||0.012||||||The Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.012
71839736|NCT05583578|143187924|OTHER||Cohen's d (effect size)|0.98|||||TWO_SIDED||||||||Effect sizes greater than (d = 0.80) were considered large.|Post-intervention changes in walking speed||||
71839737|NCT05583578|143187925|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.39
71839738|NCT05583578|143187925|SUPERIORITY||Cohen's d (effect size)|0.31|||||TWO_SIDED||||||||Effect sizes ranging from 0.21 to 0.79 were considered moderate, anything ≥0.80 were considered large.|||||
71839739|NCT04447469|143187926|SUPERIORITY||Odds Ratio (OR)|2.069||||0.2598|TWO_SIDED|95.0|0.555|8.615||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||8.615|0.555|0.2598
71839740|NCT04447469|143187926|SUPERIORITY||Odds Ratio (OR)|2.414||||0.161|TWO_SIDED|95.0|0.653|9.957||P-value and odds ratio were calculated using Fisher's Exact test.|Fisher Exact|||||9.957|0.653|0.1610
71673387|NCT01006122|142864894|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.747||0.418|TWO_SIDED|80.0|-0.81|1.12|||Mixed Models Analysis|||One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.||1.12|-0.81|0.418
71794844|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|6.6|STANDARD_ERROR_OF_MEAN|7.65||0.3903|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3903
71794845|NCT01480076|143086491|SUPERIORITY_OR_OTHER||difference of LS means|16.8|STANDARD_ERROR_OF_MEAN|15.53||0.2794|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2794
71794846|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
71794847|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.1166|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1166
71794848|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.0451|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0451
71794849|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.9327|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9327
71794850|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|5.1|STANDARD_ERROR_OF_MEAN|6.28||0.4177|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4177
71794851|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|-7.9|STANDARD_ERROR_OF_MEAN|14.64||0.5885|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5885
71794852|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.0059|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0059
71794853|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.3467|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3467
71839741|NCT04447469|143187926|SUPERIORITY||Stratified Odds Ratio|2.091||||0.2448|TWO_SIDED|95.0|0.612|7.144||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||7.144|0.612|0.2448
71839742|NCT04447469|143187926|SUPERIORITY||Stratified Odds Ratio|2.749||||0.1378|TWO_SIDED|95.0|0.756|9.993||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||9.993|0.756|0.1378
71839743|NCT04447469|143187927|SUPERIORITY||Stratified Odds Ratio|1.231||||0.4534|TWO_SIDED|95.0|0.715|2.12||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||2.120|0.715|0.4534
71673388|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.457||0.054|TWO_SIDED|80.0|-1.32|-0.15|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.15|-1.32|0.054
71673389|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.453||0.247|TWO_SIDED|80.0|-0.89|0.27|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.27|-0.89|0.247
71673390|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.457||0.095|TWO_SIDED|80.0|-1.19|-0.01|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.01|-1.19|0.095
71673391|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|0.13|STANDARD_ERROR_OF_MEAN|0.487||0.604|TWO_SIDED|80.0|-0.5|0.75|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.75|-0.50|0.604
71673392|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.473||0.232|TWO_SIDED|80.0|-0.95|0.26|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.26|-0.95|0.232
71673393|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.473||0.093|TWO_SIDED|80.0|-1.23|-0.02|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||-0.02|-1.23|0.093
71673394|NCT01006122|142864895|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.498||0.274|TWO_SIDED|80.0|-0.94|0.34|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.||0.34|-0.94|0.274
71673395|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.244||0.121|TWO_SIDED|80.0|-0.6|0.03|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.03|-0.60|0.121
71673396|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.243||0.394|TWO_SIDED|80.0|-0.38|0.25|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.25|-0.38|0.394
71673397|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.244||0.073|TWO_SIDED|80.0|-0.67|-0.04|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||-0.04|-0.67|0.073
71794854|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.0654|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0654
71794855|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.3965|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.3965
71794856|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|-1.3|STANDARD_ERROR_OF_MEAN|7.11||0.8548|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8548
71673398|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.495|TWO_SIDED|80.0|-0.34|0.33|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.33|-0.34|0.495
71673399|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.253||0.711|TWO_SIDED|80.0|-0.18|0.46|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.46|-0.18|0.711
71673400|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.253||0.767|TWO_SIDED|80.0|-0.14|0.51|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.51|-0.14|0.767
71673401|NCT01006122|142864896|SUPERIORITY_OR_OTHER||LS Means Difference|0.14|STANDARD_ERROR_OF_MEAN|0.266||0.698|TWO_SIDED|80.0|-0.2|0.48|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.||0.48|-0.20|0.698
71673402|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.142||0.127|TWO_SIDED|80.0|-0.34|0.02|||Mixed Models Analysis|||Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.02|-0.34|0.127
71673403|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.141||0.303|TWO_SIDED|80.0|-0.25|0.11|||Mixed Models Analysis|||Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.11|-0.25|0.303
71794857|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|-25.1|STANDARD_ERROR_OF_MEAN|21.35||0.2405|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2405
71794858|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0056
71794859|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.8105|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8105
71794860|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.047|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0470
71794861|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.6067|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6067
71794862|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|-6.0|STANDARD_ERROR_OF_MEAN|7.56||0.4309|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4309
71794863|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|16.09||0.9761|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9761
71794864|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.6261|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.6261
71794865|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.086|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0860
71794866|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.2884|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2884
71794867|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.8854|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8854
71794868|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|16.9|STANDARD_ERROR_OF_MEAN|10.88||0.1226|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1226
71794869|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|26.07||0.7249|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7249
71794870|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.5129|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5129
71794871|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.1138|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1138
71794872|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.1086|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1086
71794873|NCT01480076|143086492|SUPERIORITY_OR_OTHER|||||||0.5746|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.5746
71794874|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|10.8|STANDARD_ERROR_OF_MEAN|8.07||0.1831|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1831
71794875|NCT01480076|143086492|SUPERIORITY_OR_OTHER||difference of LS means|2.1|STANDARD_ERROR_OF_MEAN|15.54||0.8917|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.8917
71839744|NCT04447469|143187927|SUPERIORITY||Stratified Odds Ratio|1.097||||0.7414|TWO_SIDED|95.0|0.636|1.891||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.891|0.636|0.7414
71839745|NCT04447469|143187928|SUPERIORITY||Odds Ratio (OR)|0.984||||1|TWO_SIDED|95.0|0.198|4.884|||Fisher Exact|||||4.884|0.198|1.0000
71794876|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794877|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.1152|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1152
71794878|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71839746|NCT04447469|143187928|SUPERIORITY||Odds Ratio (OR)|1.286||||1|TWO_SIDED|95.0|0.26|6.417|||Fisher Exact|||||6.417|0.260|1.0000
71839747|NCT04447469|143187929|SUPERIORITY||Difference in Proportion|-15.0|||||TWO_SIDED|95.0|-45.6|15.6|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - placebo.|||15.6|-45.6|
71839748|NCT04447469|143187929|SUPERIORITY||Difference in Proportions|-27.7|||||TWO_SIDED|95.0|-56.4|0.9|||||95% CI were calculated using asymptotic normal approximation. Difference = KPL-301 - Placebo .|||0.9|-56.4|
71839749|NCT04447469|143187930|SUPERIORITY|||||||0.6229||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.6229
71839750|NCT04447469|143187930|SUPERIORITY|||||||0.5526||||||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank|||||||0.5526
71892993|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.76|<0.001
71794879|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.4578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.4578
71794880|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-6.4|STANDARD_ERROR_OF_MEAN|2.56||0.0125|TWO_SIDED||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0125
71794881|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-10.2|STANDARD_ERROR_OF_MEAN|4.23||0.0158|TWO_SIDED||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0158
71794882|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794883|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.2894|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2894
71794884|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794885|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.723|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7230
71794886|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-9.3|STANDARD_ERROR_OF_MEAN|3.2||0.0038|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0038
71794887|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|5.37||0.0097|TWO_SIDED||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0097
71794888|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71892994|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
71892995|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.54|<0.001
71839751|NCT04447469|143187931|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9426|TWO_SIDED|80.0|0.71|1.46||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.46|0.71|0.9426
71794889|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.0628|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0628
71794890|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794891|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.9232|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9232
71794892|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-5.2|STANDARD_ERROR_OF_MEAN|3.37||0.1249|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.1249
71794893|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-14.1|STANDARD_ERROR_OF_MEAN|5.42||0.0093|TWO_SIDED||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0093
71794894|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794895|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.0937|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0937
71794896|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794897|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.7814|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7814
71794898|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-3.9|STANDARD_ERROR_OF_MEAN|3.47||0.2561|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.2561
71794899|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-13.6|STANDARD_ERROR_OF_MEAN|6.07||0.0255|TWO_SIDED||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0255
71794900|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794901|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.7241|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.7241
71839752|NCT04447469|143187931|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.6838|TWO_SIDED|80.0|0.78|1.57||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy, age, and ARDS status).|||1.57|0.78|0.6838
71839753|NCT04447469|143187932|SUPERIORITY||Odds Ratio (OR)|0.235||||0.0905|TWO_SIDED|95.0|0.023|1.328|||Fisher Exact|||||1.328|0.023|0.0905
71839754|NCT04447469|143187932|SUPERIORITY||Odds Ratio (OR)|0.431||||0.2247|TWO_SIDED|95.0|0.087|1.815|||Fisher Exact|||||1.815|0.087|0.2247
71839755|NCT04447469|143187932|SUPERIORITY||Stratified Odds Ratio|0.191||||0.0623|TWO_SIDED|95.0|0.033|1.114||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.114|0.033|0.0623
71839756|NCT04447469|143187932|SUPERIORITY||Stratified Odds Ratio|0.368||||0.1957|TWO_SIDED|95.0|0.085|1.583||P-value and odds ratio were calculated using Cochran Mantel-Haenszel (CMH) test, stratified by randomization strata (standard of care antiretroviral therapy, age, and ARDS status).|Cochran-Mantel-Haenszel|||||1.583|0.085|0.1957
71839757|NCT04447469|143187933|SUPERIORITY||Hazard Ratio (HR)|1.57||||0.3766|TWO_SIDED|80.0|0.8|3.09||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||3.09|0.80|0.3766
71839758|NCT04447469|143187933|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9209|TWO_SIDED|80.0|0.51|2.16||Log-rank test is stratified by randomization strata (Standard of Care antiretroviral therapy, and age).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (Standard of Care antiretroviral therapy and age).|||2.16|0.51|0.9209
71839759|NCT04447469|143187934|SUPERIORITY||Stratified Odds Ratio|0.645||||0.1772|TWO_SIDED|95.0|0.34|1.222||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.222|0.340|0.1772
71839760|NCT04447469|143187934|SUPERIORITY||Stratified Odds Ratio|1.029||||0.9269|TWO_SIDED|95.0|0.563|1.881||Calculated using Cochran Mantel-Haenszel test, stratified by randomization strata (age and ARDS status).|Cochran-Mantel-Haenszel|||||1.881|0.563|0.9269
71839761|NCT04447469|143187935|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9578|TWO_SIDED|95.0|0.66|1.49||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.49|0.66|0.9578
71839762|NCT04447469|143187935|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5274|TWO_SIDED|95.0|0.76|1.7||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age and ARDS status).|||1.70|0.76|0.5274
71839763|NCT04447469|143187936|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1336|TWO_SIDED|95.0|0.36|1.15||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age, and ARDS status).|||1.15|0.36|0.1336
71794902|NCT01480076|143086493|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||<0.0001
71794903|NCT01480076|143086493|SUPERIORITY_OR_OTHER|||||||0.0427|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0427
71794904|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|-7.2|STANDARD_ERROR_OF_MEAN|3.67||0.0498|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.0498
71839764|NCT04447469|143187936|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9767|TWO_SIDED|95.0|0.59|1.72||Log-rank test is stratified by randomization strata (age, and ARDS status).|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata ( age, and ARDS status).|||1.72|0.59|0.9767
71839765|NCT04447469|143187937|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.55|3.71|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||3.71|0.55|
71839766|NCT04447469|143187937|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|0.78|4.54|||||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by randomization strata (age).|||4.54|0.78|
71839767|NCT05201079|143187938|SUPERIORITY||Odds Ratio (OR)|2.395||||0.228|TWO_SIDED|97.79|0.54|10.624||Alpha: 0.0221|Regression, Logistic||Numerator: fidaxomicin; denominator: MBK-01|||10.624|0.540|0.228
71839768|NCT05201079|143187944|SUPERIORITY|||||||||||||||||Alpha value used: 0.0221|Statistical analysis using Odds Ratio cannot be performed because there are zero patients with bad progress in MBK-01 group.|||
71839769|NCT05201079|143187945|SUPERIORITY||Score (logrank) test|1.25||||0.3|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.300
71839770|NCT05201079|143187947|SUPERIORITY||Score (logrank) test|0.02||||0.9|TWO_SIDED|||||Alpha: 0.0221|Regression, Cox|Degrees of freedom: 1||||||0.900
71839771|NCT05201079|143187958|SUPERIORITY|||||||0.749||||||Main effect of the Group for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.104.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.749
71839772|NCT05201079|143187958|SUPERIORITY|||||||0.62||||||Main effect of the Visit for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 0.249.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.620
71839773|NCT05201079|143187958|SUPERIORITY|||||||0.16||||||Main effect of the Group x Visit interaction for the Physical Function area of the SF-36 questionnaire. F statistic (1,56) = 2.024.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.160
71839774|NCT05201079|143187958|SUPERIORITY|||||||0.614||||||Main effect of the Group for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.257.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.614
71839775|NCT05201079|143187958|SUPERIORITY|||||||0.007||||||Main effect of the Visit for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 7.705. Effect size = 0.046.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.007
71839776|NCT05201079|143187958|SUPERIORITY|||||||0.718||||||Main effect of the Group x Visit interaction for the Bodily pain area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
71839777|NCT05201079|143187958|SUPERIORITY|||||||0.494||||||Main effect of the Group for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.474.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.494
71839778|NCT05201079|143187958|SUPERIORITY|||||||0.339||||||Main effect of the Visit for the General Health area of the SF-36 questionnaire. F statistic (1,56) = 0.932.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.339
71839779|NCT05201079|143187958|SUPERIORITY|||||||0.38||||||Main effect of the Group x Visit interaction for the General health area of the SF-36 questionnaire. F statistic (1,56) = 0.783.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.380
71839780|NCT05201079|143187958|SUPERIORITY|||||||0.79||||||Main effect of the Group for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.072|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.790
71839781|NCT05201079|143187958|SUPERIORITY|||||||0.498||||||Main effect of the Visit for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 0.465.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.498
71839782|NCT05201079|143187958|SUPERIORITY|||||||0.023||||||Main effect of the Group x Visit interaction for the Vitality area of the SF-36 questionnaire. F statistic (1,56) = 5.490.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.023
71839783|NCT05201079|143187958|SUPERIORITY|||||||0.553||||||Main effect of the Group for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.356.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.553
71839784|NCT05201079|143187958|SUPERIORITY|||||||0.718||||||Main effect of the Visit for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.132.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.718
71839785|NCT05201079|143187958|SUPERIORITY|||||||0.574||||||Main effect of the Group x Visit interaction for the Social role area of the SF-36 questionnaire. F statistic (1,56) = 0.319.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.574
71839786|NCT05201079|143187958|SUPERIORITY|||||||0.49||||||Main effect of the Group for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 0.482.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.490
71839787|NCT05201079|143187958|SUPERIORITY|||||||0.032||||||Main effect of the Visit for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 4.850|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.032
71839788|NCT05201079|143187958|SUPERIORITY|||||||0.145||||||Main effect of the Group x Visit interaction for the Emotional role area of the SF-36 questionnaire. F statistic (1,56) = 2.181.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.145
71839789|NCT05201079|143187958|SUPERIORITY|||||||0.467||||||Main effect of the Group for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.535.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.467
71839790|NCT05201079|143187958|SUPERIORITY|||||||0.1||||||Main effect of the Visit for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 2.795|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.100
71839791|NCT05201079|143187958|SUPERIORITY|||||||0.89||||||Main effect of the Group x Visit interaction for the Mental health area of the SF-36 questionnaire. F statistic (1,56) = 0.019.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.890
71673404|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.738|TWO_SIDED|80.0|-0.09|0.27|||Mixed Models Analysis|||Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.27|-0.09|0.738
71794905|NCT01480076|143086493|SUPERIORITY_OR_OTHER||difference of LS means|0.7|STANDARD_ERROR_OF_MEAN|5.95||0.9078|TWO_SIDED||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.||||0.9078
71794906|NCT01589445|143086513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.06|STANDARD_DEVIATION|39.47|<|0.161||95.0|-88.0|118.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TC||118|-88.0|<0.161
71794907|NCT01589445|143086513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.66|STANDARD_DEVIATION|143.22|<|0.913|TWO_SIDED|95.0|-397.0|976.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TG||976|-397.0|<0.913
71794908|NCT01589445|143086513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|9.59|<|0.322|TWO_SIDED|95.0|-35.0|19.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HDL||19.0|-35.0|<0.322
71794909|NCT01589445|143086513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.62|STANDARD_DEVIATION|32.05|<|0.21|TWO_SIDED|95.0|-113.8|76.2||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||LDL||76.2|-113.8|<0.210
71794910|NCT01589445|143086514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_DEVIATION|2.41|<|0.05|TWO_SIDED|95.0|-7.9|8.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)|ANOVA||The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).|Change from Baseline in FSG at 3rd month||8.0|-7.9|<0.05
71794911|NCT01589445|143086515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64|STANDARD_DEVIATION|1.07|>|0.05|TWO_SIDED|95.0|-4.4|2.4||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||2.4|-4.4|>0.05
71794912|NCT01589445|143086516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.12|<|0.001|TWO_SIDED|95.0|-0.4|0.27||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||||0.27|-0.40|<0.001
71794913|NCT01589445|143086516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04|STANDARD_DEVIATION|4.25|<|0.004|TWO_SIDED|95.0|-14.12|15.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA IR||15.52|-14.12|<0.004
71794914|NCT01589445|143086517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.79|STANDARD_DEVIATION|84.46|<|0.808|TWO_SIDED|95.0|-346.4|328.1||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA B||328.10|-346.40|<0.808
71794915|NCT01589445|143086517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.53|STANDARD_DEVIATION|54.0|<|0.025|TWO_SIDED|95.0|-148.7|180.0||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA S||180|-148.70|<0.025
71794916|NCT01589445|143086518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|STANDARD_DEVIATION|10.2|<|0.039|TWO_SIDED|95.0|-27.04|26.52||Category: Univariate \& Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||FSI||26.52|-27.04|<0.039
71839792|NCT05201079|143187958|SUPERIORITY|||||||0.742||||||Main effect of the Group for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.742
71839793|NCT05201079|143187958|SUPERIORITY||||||<|0.001||||||Main effect of the Visit for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 21.912. Effect size = 0.109.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||<0.001
71673405|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|0.16|STANDARD_ERROR_OF_MEAN|0.152||0.85|TWO_SIDED|80.0|-0.04|0.35|||Mixed Models Analysis|||Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.35|-0.04|0.850
71794917|NCT01334723|143086529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||||95.0|0.35|0.412|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.412|0.350|
71794918|NCT01334723|143086529|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.294||||||95.0|0.235|0.368|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.368|0.235|
71794919|NCT01334723|143086530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.613||||||95.0|0.562|0.668|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.668|0.562|
71794920|NCT01334723|143086530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542||||||95.0|0.427|0.689|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.689|0.427|
71794921|NCT01334723|143086531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519||||||95.0|0.472|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.472|
71794922|NCT01334723|143086531|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.436||||||95.0|0.333|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.|||0.570|0.333|
71794923|NCT02439320|143086592|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.001|TWO_SIDED|95.0|1.6|3.0|||Regression, Logistic|||||3.0|1.6|<0.001
71794924|NCT02439320|143086592|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|2.0|3.6|||Regression, Logistic|||||3.6|2.0|<0.001
71839794|NCT05201079|143187958|SUPERIORITY|||||||0.089||||||Main effect of the Group x Visit interaction for the Physical Role area of the SF-36 questionnaire. F statistic (1,56) = 2.986.|ANOVA|||For each area of the SF-36 questionnaire, a mixed ANOVA for the effect of Group, Visit, and interaction effect of Group x Visit was performed. alpha = 0.0221.||||0.089
71673406|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|0.05|STANDARD_ERROR_OF_MEAN|0.148||0.631|TWO_SIDED|80.0|-0.14|0.24|||Mixed Models Analysis|||Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.24|-0.14|0.631
71673407|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.16|TWO_SIDED|80.0|-0.34|0.04|||Mixed Models Analysis|||Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.04|-0.34|0.160
71673408|NCT01006122|142864899|SUPERIORITY_OR_OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.156||0.541|TWO_SIDED|80.0|-0.18|0.22|||Mixed Models Analysis|||Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.||0.22|-0.18|0.541
71673409|NCT02268916|142864926|SUPERIORITY|The study was powered based on a two-sample t-test of the primary outcomes, changes in physical activity or social participant over 6 months. Based on previous literature, in order to detect an effect size of 0.28 with at least 70% power, we aimed to recruit at least 35 participants in each treatment group.|Mean Difference (Final Values)|0.39|||=|0.18|TWO_SIDED|95.0|-0.18|0.97|||Mixed Models Analysis|The outcome was adjusted for time of visit, visit x intervention group, age, gender, body mass index, insulin, depression, and time-up-and-go score.||We hypothesized that at the end of 6 months, the intervention group will have increased physical activity as measured by CHAMPS compared to the control group.||0.97|-0.18|=0.18
71673410|NCT02268916|142864927|SUPERIORITY||Slope|-2.2||||0.19|TWO_SIDED|95.0|-5.45|1.06|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in social roles.||1.06|-5.45|0.19
71673411|NCT02268916|142864927|SUPERIORITY||Slope|-1.02||||0.57|TWO_SIDED|95.0|-4.53|2.48|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by satisfaction with participation in discretionary social activities.||2.48|-4.53|0.57
71794925|NCT02439320|143086593|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
71794926|NCT02439320|143086593|SUPERIORITY||Odds Ratio, log|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
71794927|NCT02439320|143086594|SUPERIORITY||Odds Ratio, log|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
71794928|NCT02439320|143086594|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.001|TWO_SIDED|95.0|1.9|3.3|||Regression, Logistic|||||3.3|1.9|<0.001
71794929|NCT02439320|143086595|SUPERIORITY||Odds Ratio (OR)|1.7|||=|0.029|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|||||2.8|1.1|=0.029
71839795|NCT04752709|143187975|OTHER||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
71839796|NCT00324805|143188039|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox||Arm II versus Arm I|||1.19|0.82|0.90
71673412|NCT02268916|142864927|SUPERIORITY||Slope|-2.44||||0.12|TWO_SIDED|95.0|-5.52|0.63|||Mixed Models Analysis|||We hypothesized that at the end of 6 months, intervention group will have improved participation as measured by the survey on the ability to participate in social roles and activities.||0.63|-5.52|0.12
71673413|NCT02268916|142864928|SUPERIORITY||Slope|-1.99|||<|0.05|TWO_SIDED|95.0|-3.97|-0.02|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in timed up and go test.||-0.02|-3.97|<0.05
71673414|NCT02268916|142864929|SUPERIORITY||Slope|0.11||||0.02|TWO_SIDED|95.0|0.02|0.2|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in gait speed.||0.20|0.02|0.02
71673415|NCT02268916|142864930|SUPERIORITY||Slope|40.04||||0.02|TWO_SIDED|95.0|7.9|72.17|||Mixed Models Analysis|||We hypothesized that at 6-month follow-up, the intervention group will have better performance than the control group in six-minute walk test.||72.17|7.90|0.02
71794930|NCT02439320|143086595|SUPERIORITY||Odds Ratio (OR)|2.1|||=|0.002|TWO_SIDED|95.0|1.3|3.4|||Regression, Logistic|||||3.4|1.3|=0.002
71794931|NCT02439320|143086596|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Regression, Logistic|||||0.5|0.3|<0.001
71794932|NCT02439320|143086596|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Regression, Logistic|||||0.4|0.2|<0.001
71794933|NCT02439320|143086597|SUPERIORITY||Odds Ratio, log|0.7||||0.12|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.120
71794934|NCT02439320|143086597|SUPERIORITY||Odds Ratio (OR)|0.6||||0.035|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.035
71794935|NCT02439320|143086599|SUPERIORITY||Odds Ratio (OR)|1.1||||0.386|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.386
71794936|NCT02439320|143086599|SUPERIORITY||Odds Ratio (OR)|1.1||||0.47|TWO_SIDED|95.0|0.9|1.4|||Regression, Linear|||||1.4|0.9|0.470
71794937|NCT02439320|143086600|SUPERIORITY||Odds Ratio (OR)|1.4||||0.006|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.006
71794938|NCT02439320|143086600|SUPERIORITY||Odds Ratio (OR)|1.3||||0.037|TWO_SIDED|95.0|1.0|1.6|||Regression, Logistic|||||1.6|1.0|0.037
71794939|NCT02439320|143086601|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.5|2.4|||Regression, Logistic|||||2.4|1.5|<0.001
71794940|NCT02439320|143086601|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|2.2|||Regression, Logistic|||||02.2|1.4|<0.001
71794941|NCT02972632|143086605|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
71839797|NCT00324805|143188040|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.86|1.15|||Regression, Cox||Arm II vs. Arm I|||1.15|0.86|0.95
71839798|NCT05778695|143188060|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|-14.0|STANDARD_DEVIATION|22.02||0.875|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.875
71794942|NCT02972632|143086605|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
71794943|NCT02972632|143086606|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
71794944|NCT02972632|143086606|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
71794945|NCT02972632|143086607|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline||||<0.001
71794946|NCT02972632|143086607|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
71794947|NCT02972632|143086608|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
71794948|NCT02972632|143086609|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
71794949|NCT02972632|143086610|OTHER||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline||||<0.001
71794950|NCT02245841|143086612|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||< .001
71794951|NCT02245841|143086613|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
71794952|NCT02245841|143086614|SUPERIORITY|||||||0.002|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.002
71839799|NCT05778695|143188060|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-2.0|STANDARD_DEVIATION|15.166||0.739|TWO_SIDED|95.0|-16.026|12.026||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|||||12.026|-16.026|0.739
71839800|NCT05778695|143188061|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Median Difference (Net)|0.0|STANDARD_DEVIATION|0.34||0.37|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.37
71673416|NCT03926117|142864933|SUPERIORITY||Median Difference (Final Values)|-66.2|||<|0.0001|TWO_SIDED|95.0|-86.15|-49.12|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (greater than or equal to (\>=) 11 or less than (\<) 11 grams per deciliter (g/dL)) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-49.12|-86.15|<0.0001
71794953|NCT02245841|143086615|SUPERIORITY|||||||0.05|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||0.050
71794954|NCT02245841|143086616|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|||Analysis performed was two-sided Wilcoxon signed rank test. Median differences with interquartile range are reported in outcome measure data.||||<0.001
71794955|NCT01835743|143086620|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
71794956|NCT01835743|143086621|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups||||||<0.0001
71794957|NCT01451775|143086622|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|84.04|STANDARD_DEVIATION|6.4|||TWO_SIDED|90.0|80.856|87.344|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||87.344|80.856|
71794958|NCT01451775|143086622|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9367|STANDARD_ERROR_OF_MEAN|0.0178|||TWO_SIDED|95.0|0.8988|0.9746||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||0.9746|0.8988|
71794959|NCT01451775|143086623|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|63.22|STANDARD_DEVIATION|18.1|||TWO_SIDED|90.0|56.736|70.439|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation.|||70.439|56.736|
71794960|NCT01451775|143086623|NON_INFERIORITY_OR_EQUIVALENCE|This is an analysis of dose proportionality|Slope|0.9065|STANDARD_DEVIATION|0.0495|||TWO_SIDED|95.0|0.8011|1.012||Does proportionality would be assumed if the 95% confidence interval includes one.|ANCOVA|ANCOVA with logarithm of the dose fitted as a continuous covariate and sequence, subjects within sequence, period included as categorical variables.||||1.0120|0.8011|
71813330|NCT01181726|143129087|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.83|||||TWO_SIDED|90.0|94.55|101.21|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.21|94.55|
71839801|NCT01733316|143188078|SUPERIORITY|||||||0.0048||||||Paired t-test testing the null hypothesis that the population average difference during the Cystagon® phase is equal to the population average difference during the RP103 phase.|Paired t-test, two-sided|||||||0.0048
71839802|NCT01674140|143188095|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.77|1.14|||Log Rank|||||1.14|0.77|0.52
71839803|NCT01674140|143188096|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.84|TWO_SIDED|95.0|0.75|1.26|||Log Rank|||||1.26|0.75|0.84
71839804|NCT01674140|143188098|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.32|TWO_SIDED|95.0|0.74|1.1|||Log Rank|||||1.10|0.74|0.32
71839805|NCT02606422|143188108|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71794961|NCT03054870|143086648|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
71794962|NCT03054870|143086649|NON_INFERIORITY|The non-inferiority margin was determined from a separate study where 6 blinded readers read and re-read 75 Xe-133 planar ventilation imaging studies in 2 read sessions separated by a minimum of 4 weeks. The readers scored the 6 regions of the lung using the same ventilation scoring metric used in this study. Based on analysis of the read/re-read results, 60% was established as a suitable margin for establishing the non-inferiority of Technegas compared to Xe-133.|||||<|0.0141||||||P-value is one-sided; for testing non-inferiority the associated critical value for PA is provided by lower bound of the 97.18% confidence interval.|Mixed Models Analysis|Binary agreement scores between Technegas and Xe-133 ventilation scores by subject-lung region served as the dependent variable in the model.||PA between Technegas and Xe-133 from analysis of each of the 3 blinded readers' ventilation scores was subjected to the following test of null (H0) versus alternate hypotheses (HA): H0: PA \<= 60% versus HA: PA \> 60%. The original sample size of 240 subjects was based on 90% power and one-sided alpha=0.025. For the unplanned interim analysis of 200 subjects, testing for non-inferiority used one-sided alpha=0.0141 (critical value provided by lower bound of the 97.18% confidence interval).|Binary agreement scores were analyzed for each reader separately using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement (PA). For the study to be considered a success, the null hypothesis had to be rejected for at least 2 of the 3 blinded readers for the primary efficacy endpoint.|||<0.0141
71794963|NCT03054870|143086650|OTHER||||||||||||||||||Estimates of inter-observer percent agreement were obtained as follows. For each reader-pair, binary agreement scores by subject and lung region were analyzed using a generalized linear model with SAS® PROC GENMOD. The logit function (log odds ratio) was specified as the link function, and subject was specified as a repeated measure to allow for correlations between lung regions within a subject. The estimate of the intercept of the model using generalized estimating equation (GEE) methodology provided an overall estimate of the agreement and corresponding confidence interval in terms of the log odds ratio. Simple algebra was used to obtain the corresponding estimates and confidence intervals in terms of percent agreement.|||
71794964|NCT03054870|143086651|OTHER||||||||||||||||||For each pair of readers, by lung region estimates of kappa statistics and their corresponding 95% confidence intervals were generated from cross-tabulation frequencies of the readers' ventilation scores using SAS® PROC FREQ and the AGREE option.|||
71794965|NCT02590939|143086670|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71794966|NCT02590939|143086671|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71794967|NCT02590939|143086672|SUPERIORITY|||||||0.666||||||Statistical significance threshold set to 0.05|Fisher Exact|||||||0.666
71794968|NCT02590939|143086673|SUPERIORITY|||||||0.026||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.026
71794969|NCT02590939|143086674|SUPERIORITY|||||||1||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||1
71794970|NCT02590939|143086675|SUPERIORITY|||||||0.037||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.037
71794971|NCT02590939|143086676|SUPERIORITY|||||||0.028||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.028
71794972|NCT02590939|143086677|SUPERIORITY|||||||0.062||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.062
71794973|NCT00108160|143086682|SUPERIORITY_OR_OTHER|||||||0.356||||||No adjustments were made for multiple comparisons.|Chi-squared|||Our null hypothesis was that no significant effect of mupirocin ointment (treatment) on S. aureus re-infection would be seen at 18 months compared with placebo ointment. Based on prior studies, we estimated that 198 participants would need to be enrolled assuming a 20% dropout rate; 84 participants per arm would be required to detect a 66% decrease in re-infection from 30% to 10% with a significance level alpha of 0.05 and a power of 0.9.||||0.356
71794974|NCT01527682|143086711|OTHER||Proportion|76.7|||||TWO_SIDED|95.0|64.1|89.4|||||||The statistical analysis was performed according to study design. Using a Fleming single stage design (A'Hern approach) setting the probability of erroneously concluding that the responders rate is greater than 35% at 5% (one-sided alpha=0.05) and the probability of correctly concluding that the responders rate is at least 50% at 80% (beta error = 0.20), the minimum number of responder eyes was set at 31 out of 68, since this result is associated with a lower limit of the 90% exact confidence interval of 35.2%.|89.4|64.1|
71794975|NCT01331148|143086715|OTHER|||||||0.0507|||||||t-test, 2 sided|||Due to the longitudinal nature of the data and presence of missing values, repeated measures analyses were conducted using the MIXED procedure in SAS. Spearman's rank correlation coefficient was used to quantify the relationship between PedsQL scores with 25OHD concentrations and pain days. Two-way analysis of variance models compared PedsQL scores between treatment groups over time.||||0.0507
71794976|NCT05477875|143086716|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||Wilcoxon (Mann-Whitney)|||||||0.538
71794977|NCT05477875|143086717|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.538|||||||ANOVA|||||||0.538
71794978|NCT05477875|143086718|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
71839806|NCT04625465|143188129|OTHER||Difference in the log odds ratios|0.042||||0.869|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.869
71839807|NCT04625465|143188130|OTHER||Difference in the log odds ratios|-0.32||||0.21|||||||Multilevel logistic regression|||"Multilevel logistic regression of daily IPV perpetration on alcohol use (Level 1) nested within participant (Level 2) with interaction between alcohol use and CBT Intervention.~Testing the difference in odds ratio between groups 1 (No Intervention and Attention Control ) and 2 (CBT Texts Intervention) H0: OR1 = OR2"||||.210
71794979|NCT05477875|143086719|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and PROWL-SS from (1-100) as the dependent variable."|||||<|0.851|||||||ANOVA|||||||<0.851
71794980|NCT05477875|143086720|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and QIRC from (1-100) as the dependent variable."|||||<|0.543|||||||ANOVA|||||||<0.543
71794981|NCT05477875|143086721|EQUIVALENCE|"Alpha = 0.05, two-way ANOVA with Group x Time Points as fixed factors and OSDI from (0-48) as the dependent variable."||||||0.725|||||||ANOVA|||||||0.725
71794982|NCT05477875|143086722|EQUIVALENCE|Two-way ANOVA using group and intervention as fixed factors were analyzed, with outcome variable p-value reported below, threshold 0.05.||||||0.516|||||||ANOVA|||||||0.516
71794983|NCT04254978|143086737|SUPERIORITY||||||<|0.0001|||||||Exact binomial distribution|||Comparison of the true response rate of bomedemstat to a fixed efficacy target of 5%: Null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p \> 0.05||||<.0001
71794984|NCT00277212|143086738|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.552||||0.058|TWO_SIDED|95.0|0.296|1.03||stratified Log-Rank test, controlling for type of index mood episode|Log Rank||Cox's proportional hazards model, with type of index modd episode as stratification factor, and randomized treatment group as covariate.|||1.030|0.296|0.058
71794985|NCT00277212|143086739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.671||||0.055|TWO_SIDED|95.0|0.446|1.011||p-value for equality of survival curves|Log Rank|stratified log-rank test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.011|0.446|0.055
71794986|NCT00277212|143086740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784||||0.381|TWO_SIDED|95.0|0.454|1.354||p-value for equality of survival curves|Log Rank|stratified log-rank test, conrolling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.354|0.454|0.381
71673417|NCT03926117|142864933|SUPERIORITY||Median Difference (Final Values)|-77.71|||<|0.0001|TWO_SIDED|95.0|-94.98|-62.97|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-62.97|-94.98|<0.0001
71794987|NCT00277212|143086741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.871||||0.295|TWO_SIDED|95.0|0.672|1.128||p-value for equality of survival curves|Log Rank|stratified Log-Rank Test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.|||1.128|0.672|0.295
71794988|NCT00277212|143086743|SUPERIORITY_OR_OTHER||Treatement Difference|2.24||||0.001|TWO_SIDED|95.0|0.91|3.57||ANOVA (main effects=double-blind treatment, covariate=index mood episode) used for baseline comparisons. ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons|ANCOVA||Aripiprazole vs. placebo|Week 52 LOCF||3.57|0.91|0.001
71794989|NCT00277212|143086744|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.56||||0.073|TWO_SIDED|95.0|0.29|1.07|||Cochran-Mantel-Haenszel||aripiprazole/placebo|Week 52 LOCF||1.07|0.29|0.073
71794990|NCT00277212|143086744|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Cochran-Mantel-Haenszel|||At Any Time||||0.194
71794991|NCT00277212|143086745|SUPERIORITY_OR_OTHER||relative risk|3.41||||0.007|TWO_SIDED|95.0|1.3|8.94|||Cochran-Mantel-Haenszel|||Week 52 LOCF||8.94|1.30|0.007
71794992|NCT00277212|143086745|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71794993|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.467|TWO_SIDED|95.0|-2.37|1.09||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA model, with double-blind treatment as main effects and index mood episode as covariate, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||1.09|-2.37|0.467
71794994|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|95.0|-0.06|0.78||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 12||0.78|-0.06|
71794995|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|||||TWO_SIDED|95.0|0.19|1.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||1.30|0.19|
71839808|NCT05566639|143188137|NON_INFERIORITY|Noninferiority margin = 10%|Relative vaccine efficacy (rVE)|1.7||||0.1715|TWO_SIDED|95.0|-24.1|22.2|||Stratified Cox proportional hazards||rVE = 100 \* (1 - HR) % was defined as the percent reduction in the hazard (mRNA-1010 vs active comparator), where HR was the hazard ratio between mRNA-1010 vs the active comparator.|||22.2|-24.1|0.1715
71673418|NCT03926117|142864933|SUPERIORITY||Median Difference (Final Values)|-87.76|||<|0.0001|TWO_SIDED|95.0|-101.0|-70.54|||Hodges-Lehmann method|||Percent change from baseline is analyzed using nonparametric Hodges-Lehmann estimator. The nonparametric analysis accounts for covariates baseline hemoglobin (\>= 11 or \< 11 g/dL) and chronic kidney disease stage (3, 4 or 5) by aligning responses within each stratum defined by the covariates prior to analysis.||-70.54|-101.00|<0.0001
71794996|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|||||TWO_SIDED|95.0|0.08|1.86||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||1.86|0.08|
71794997|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||||TWO_SIDED|95.0|-0.08|1.92||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||1.92|-0.08|
71794998|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.001|TWO_SIDED|95.0|0.31|1.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||1.26|0.31|0.001
71794999|NCT00277212|143086746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.002|TWO_SIDED|95.0|0.23|1.04||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode \& baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from baseline||1.04|0.23|0.002
71795000|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.971|TWO_SIDED|95.0|-0.35|0.34||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, with double-blind treatment as main effects, is used for Baseline comparisons.|aripiprazole - placebo|Baseline||0.34|-0.35|0.971
71795001|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.03|0.51||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 8||0.51|-0.03|
71795002|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.60|-0.13|
71795003|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.06|0.55||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.55|-0.06|
71795004|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-0.06|0.65||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.65|-0.06|
71795005|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.095|TWO_SIDED|95.0|-0.04|0.52||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.52|-0.04|0.095
71795006|NCT00277212|143086752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.061|TWO_SIDED|95.0|-0.01|0.63||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripirazole - placebo|Highest change from Baseline||0.63|-0.01|0.061
71795007|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.458||95.0|-0.25|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, controlling for treatment, is used for baseline estimates.|aripiprazole - placebo|Baseline||0.11|-0.25|0.458
71892996|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.85|-0.49|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.49|-0.85|<0.001
71892997|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.63|-0.25|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.25|-0.63|<0.001
71892998|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.57|-0.19|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.57|<0.001
71795008|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-0.05|0.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.26|-0.05|
71795009|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.11|0.2||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 24||0.20|-0.11|
71795010|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|95.0|0.0|0.42||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 36||0.42|0.00|
71795011|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at week 52||0.16|-0.05|
71795012|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.515|TWO_SIDED|95.0|-0.22|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)||0.11|-0.22|0.515
71795013|NCT00277212|143086753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.73|TWO_SIDED|95.0|-0.16|0.23||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.23|-0.16|0.730
71795014|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.435|TWO_SIDED|95.0|-0.08|0.2||Means, mean differences, 95% confidence intervals for the differences, and the p-values are based on ANOVA/ANCOVA model.|ANOVA|ANOVA, controlling for treatment, used for baseline estimates.|aripiprazole - placebo|Baseline||0.20|-0.08|0.435
71795015|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|0.04|0.3||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 8||0.30|0.04|
71795016|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.11|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 24||0.17|-0.11|
71795017|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 36||0.13|-0.13|
71795018|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.08|0.14||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52||0.14|-0.08|
71795019|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.358|TWO_SIDED|95.0|-0.06|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)||0.17|-0.06|0.358
71892999|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.42|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-0.80|<0.001
71893000|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.035|TWO_SIDED|95.0|-0.42|-0.02|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.02|-0.42|0.035
71893001|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.125|TWO_SIDED|95.0|-0.36|0.04|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.04|-0.36|0.125
71795020|NCT00277212|143086754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.021|TWO_SIDED|95.0|0.03|0.31||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline||0.31|0.03|0.021
71795021|NCT03336216|143086756|SUPERIORITY||Hazard Ratio (HR)|1.47|||||TWO_SIDED|60.0|1.19|1.82||||||||1.82|1.19|
71795022|NCT03336216|143086756|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|60.0|0.77|1.3||||||||1.30|0.77|
71795023|NCT03336216|143086756|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|60.0|0.6|1.03||||||||1.03|0.60|
71795024|NCT03336216|143086757|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|60.0|1.33|2.02||||||||2.02|1.33|
71795025|NCT03336216|143086757|SUPERIORITY||Hazard Ratio (HR)|1.13||||||60.0|0.87|1.46||||||||1.46|0.87|
71795026|NCT03336216|143086757|SUPERIORITY||Hazard Ratio (HR)|0.72||||||60.0|0.55|0.94||||||||0.94|0.55|
71795027|NCT03336216|143086760|SUPERIORITY||Strata adjusted difference|1.8||||0.6537||95.0|-5.5|9.0||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||9.0|-5.5|0.6537
71795028|NCT03336216|143086760|SUPERIORITY||Strata adjusted difference|12.5||||0.0951||95.0|3.1|21.9||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||21.9|3.1|0.0951
71795029|NCT03336216|143086760|SUPERIORITY||Strata adjusted difference|5.0||||0.5171||95.0|-8.0|18.1||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||18.1|-8.0|0.5171
71795030|NCT03336216|143086761|SUPERIORITY||Strata adjusted difference|-0.8||||0.8505|TWO_SIDED|95.0|-9.4|7.7||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||7.7|-9.4|0.8505
71795031|NCT03336216|143086761|SUPERIORITY||Strata adjusted difference|1.5||||0.8144|TWO_SIDED|95.0|-9.9|12.8||Stratified CMH test stratified by ECOG and prior chemotherapy|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.8|-9.9|0.8144
71795032|NCT03336216|143086761|SUPERIORITY||Strata adjusted difference|0.7||||0.9087|TWO_SIDED|95.0|-10.7|12.1||Stratified CMH test stratified by ECOG and prior chemotherapy.|Cochran-Mantel-Haenszel||Based on Cochran-Mantel-Haenszel (CMH) method of weighting|||12.1|-10.7|0.9087
71795033|NCT03336216|143086764|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.76|1.96|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.96|0.76|
71795034|NCT03336216|143086764|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.59|1.86|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.86|0.59|
71795035|NCT03336216|143086764|SUPERIORITY||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.45|1.46|||||Stratified Cox proportional hazard model by ECOG and type of prior chemotherapy|||1.46|0.45|
71795036|NCT01023581|143086791|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.96|-0.37||For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.|ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.||-0.37|-0.96|<0.001
71795037|NCT01023581|143086791|SUPERIORITY_OR_OTHER||LS mean difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.87|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate||||-0.27|-0.87|<0.001
71795038|NCT01023581|143086791|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|||<|0.001|TWO_SIDED|95.0|-1.29|-0.71|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.71|-1.29|<0.001
71795039|NCT01023581|143086791|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.73|-0.16|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||||-0.16|-0.73|<0.001
71795040|NCT00278954|143086794|SUPERIORITY_OR_OTHER||SABI per subject per year|0.0||||0.01||99.0|0.0|0.101|||Poisson regression with log link||Mean SABI rate = 0 per subject per year. 1-sided 99% upper confidence bound could not be calculated.|The estimated serious acute bacterial infection (SABI) rate was calculated by dividing no. of infections by no.of subject years. The exponential of the upper limit of the 98% 2-sided Confidence Interval (CI) gave the upper, 1-sided, 99% confidence bound, estimated using Poisson regression. The equivalent upper bound per subject year was obtained by dividing this figure by total subject years.||0.101|0|0.01
71795041|NCT03760796|143086847|OTHER||Hazard Ratio (HR)|0.48||||0.018|TWO_SIDED|95.0|0.26|0.88||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||0.88|0.26|0.018
71795042|NCT03760796|143086848|OTHER|A Markov Model of cost-effectiveness, based on 30-day readmission rates, was built to assess the Incremental Cost-Effectiveness Ratio (ICER) of adopting the Corrie Platform compared to standard of care for post AMI patients; taking into account the estimated cost of Corrie ($2,750 per patient for a 1-year use term). The reported value is a ratio of the relative cost of intervention compared to the standard of care divided by the change in the outcome, quality-adjusted life years (QALYs).|Incremental Cost-Effectiveness Ratio|-7.0|||||TWO_SIDED||||||||A negative ICER means the intervention cost is lower than the cost of standard of care, while the denominator was positive. A positive ICER means the intervention cost is greater than the cost of standard of care, while the denominator was positive.|||||
71795043|NCT03760796|143086862|OTHER||Hazard Ratio (HR)|1.45||||0.33|TWO_SIDED|95.0|0.69|2.98||The a priori threshold for statistical significance was \<0.05.|Regression, Cox|Adjusting for hospital site and a propensity score inclusive of individual level baseline characteristics.||||2.98|0.69|0.33
71893002|NCT00733902|143307157|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.58|-0.18|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.58|<0.001
71893003|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.14|-0.49|<0.001
71893004|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.486|TWO_SIDED|95.0|-0.24|0.11|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.11|-0.24|0.486
71893005|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.008|TWO_SIDED|95.0|-0.42|-0.06|||ANCOVA|||Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.06|-0.42|0.008
71795044|NCT05664490|143086880|SUPERIORITY||Risk Ratio (RR)|0.88||||0.44|TWO_SIDED|95.0|0.64|1.22||The threshold for statistical significance is 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on PrEP adherence at Week 12|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.22|0.64|0.44
71795045|NCT05664490|143086881|SUPERIORITY||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.71|1.42||The threshold for statistical significance was 0.05.|Poisson regression|We used Poisson regression with a log-link and robust standard errors to assess the effect of our intervention on reduced CMD symptoms at Week 12.|The reference category for the risk ratio presented is the Standard of Care Mental Health Services arm.|||1.42|0.71|0.99
71795046|NCT05664490|143086882|SUPERIORITY||Risk Ratio (RR)|1.4||||0.03|TWO_SIDED|95.0|1.03|1.89||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to estimate to assess the effect of our intervention on PrEP adherence at Week 4.|The Standard of Care Mental Health Services arm was the reference category for the risk ratio.|||1.89|1.03|0.03
71795047|NCT05664490|143086883|SUPERIORITY||Risk Ratio (RR)|0.81||||0.37|TWO_SIDED|95.0|0.5|1.29||The threshold for statistical significance was 0.05|Poisson regression|We used Poisson regression with a log-link to assess the effect of the intervention on common mental disorders at Week 4.|The Standard of Care Mental Health Services arm was the reference category.|||1.29|0.50|0.37
71795048|NCT01817725|143086887|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71795049|NCT00176592|143086897|SUPERIORITY|This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||This includes p value for rank sum test treatment comparison. This includes p value for rank sum test treatment comparison of intention to treat study population.||||<0.05
71795050|NCT03089606|143086976|OTHER|2-tailed Fisher's exact test||||||0.08|||||||2-tailed Fisher's exact test|||Null hypothesis. No association between baseline C11-AMT PET SUVmax value and antitumor response to pembrolizumab.||||0.08
71795051|NCT00566150|143087003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.29
71795052|NCT00566150|143087004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED|95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.||||0.07
71795053|NCT00566150|143087005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0||||Statistical significance was p\<0.05|Fisher Exact|Fisher's exact test was used to test for significance between groups.||Week 6||||.038
71795054|NCT00566150|143087006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||95.0||||Unadjusted. Statistical significance was p\<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups.||||0.79
71795055|NCT02968979|143087013|OTHER|||||||0.0032|||||||likelihood-ratio test|||Statistical analysis applies to all rows and columns.||||0.0032
71795056|NCT02968979|143087013|OTHER|||||||0.0008|||||||Chi-squared|||"Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.~Statistical analysis applies to all rows and columns."||||0.0008
71795057|NCT02968979|143087023|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
71795058|NCT02968979|143087023|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
71795059|NCT02968979|143087023|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
71795060|NCT02968979|143087023|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
71893006|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.64|-0.28|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.28|-0.64|<0.001
71893007|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.62|-0.26|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.26|-0.62|<0.001
71893008|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.75|-0.39|||ANCOVA|||Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.75|<0.001
71893009|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.53|-0.16|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.16|-0.53|<0.001
71893010|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.58|<0.001
71893011|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.89|-0.52|||ANCOVA|||Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.52|-0.89|<0.001
71893012|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.59|-0.22|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.22|-0.59|<0.001
71893013|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.55|-0.18|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.18|-0.55|<0.001
71893014|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.83|-0.46|||ANCOVA|||Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.46|-0.83|<0.001
71893015|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.47|-0.09|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.47|0.004
71893016|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.17|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.55|<0.001
71893017|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.77|-0.39|||ANCOVA|||Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.39|-0.77|<0.001
71893018|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.1||0.09|TWO_SIDED|95.0|-0.37|0.03|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.03|-0.37|0.090
71893019|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.053|TWO_SIDED|95.0|-0.39|0.0|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.00|-0.39|0.053
71673419|NCT00086138|142864981|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.52|1.97|||Chi-squared|||The statistical analyses compared data collected from the CGIC of participants who received sertraline who had a score equal to or better than the CGIC of participants who received the placebo intervention.||1.97|0.52|0.98
71795061|NCT02968979|143087023|OTHER|||||||0.1085|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||0.1085
71795062|NCT02968979|143087023|OTHER|||||||0.0482||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||0.0482
71795063|NCT02968979|143087023|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
71795064|NCT02968979|143087023|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
71795065|NCT02968979|143087023|OTHER||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.||||<0.0001
71795066|NCT02968979|143087023|OTHER||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.||||<0.0001
71795067|NCT00788827|143087041|OTHER||||||<|0.05|||||||Mixed Models Analysis|||Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.||||<0.05
71795068|NCT03979638|143087049|SUPERIORITY||Estimated percent change|-10.8||||0.1424|TWO_SIDED|95.0|-23.5|4.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||4.0|-23.5|0.1424
71893020|NCT00733902|143307158|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.30|-0.70|<0.001
71673420|NCT00086138|142864982|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.11|TWO_SIDED|95.0|0.84|5.04|||Chi-squared|||||5.04|0.84|0.11
71795069|NCT03979638|143087049|SUPERIORITY||Estimated percent change|-6.1||||0.4602|TWO_SIDED|95.0|-20.8|11.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||11.2|-20.8|0.4602
71893021|NCT02210780|143307179|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|24.29|43.75|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||43.75|24.29|<0.0001
71893022|NCT02210780|143307180|SUPERIORITY||Percentage Difference|40.2|||<|0.0001|TWO_SIDED|90.0|29.4|51.01|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||51.01|29.40|<0.0001
71795070|NCT03979638|143087049|SUPERIORITY||Estimated percent change|-7.8||||0.4181|TWO_SIDED|95.0|-24.4|12.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.5|-24.4|0.4181
71795071|NCT03979638|143087049|SUPERIORITY||Estimated percent change|-16.7||||0.0855|TWO_SIDED|95.0|-32.3|2.6|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||2.6|-32.3|0.0855
71795072|NCT03979638|143087050|SUPERIORITY||Estimated percent change|-20.3||||0.001|TWO_SIDED|95.0|-29.9|-9.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-9.5|-29.9|0.0010
71795073|NCT03979638|143087050|SUPERIORITY||Estimated percent change|-17.7||||0.0186|TWO_SIDED|95.0|-29.9|-3.3|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.3|-29.9|0.0186
71795074|NCT03979638|143087050|SUPERIORITY||Estimated percent change|-19.4||||0.032|TWO_SIDED|95.0|-33.9|-1.9|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-1.9|-33.9|0.0320
71795075|NCT03979638|143087050|SUPERIORITY||Estimated percent change|-27.0||||0.0026|TWO_SIDED|95.0|-40.3|-10.8|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-10.8|-40.3|0.0026
71839809|NCT04731818|143188150|SUPERIORITY||Mean Difference (Final Values)|0.0001|||<|0.0001|TWO_SIDED|||||analyzed by 1-way repeated measures analysis of variance (ANOVA) with post hoc Tukey multiple comparison test|ANOVA|1 way repeated measures ANOVA||||||<0.0001
71839810|NCT04159415|143188162|SUPERIORITY||Least Squares (LS) Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.4|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||2.4|-1.8|
71839811|NCT04159415|143188163|SUPERIORITY||LS Mean Difference|38.1|STANDARD_ERROR_OF_MEAN|27.3|||TWO_SIDED|95.0|-21.3|97.5|||||Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model|||97.5|-21.3|
71839812|NCT04159415|143188164|SUPERIORITY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|29.0|||TWO_SIDED|95.0|-56.9|56.9|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from ANCOVA model analyses of the different imputed data sets.|||56.9|-56.9|
71839813|NCT04159415|143188165|SUPERIORITY||Adjusted Mean Difference|17.8|STANDARD_ERROR_OF_MEAN|43.6|||TWO_SIDED|95.0|-67.6|103.2|||||Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.|||103.2|-67.6|
71839814|NCT06182033|143188188|OTHER|||||||0.84|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.84
71839815|NCT06182033|143188189|OTHER|||||||0.727|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.727
71893023|NCT02210780|143307181|SUPERIORITY||Percentage Difference|34.0|||<|0.0001|TWO_SIDED|90.0|23.38|44.66|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate \[IGA=3\] vs. severe \[IGA=4\] AD).||44.66|23.38|<0.0001
71893024|NCT02210780|143307182|SUPERIORITY||LS Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|90.0|-2.72|-1.55|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.||-1.55|-2.72|<0.0001
71839816|NCT06182033|143188190|OTHER|||||||0.205|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the assertiveness subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.205
71839817|NCT06182033|143188190|OTHER|||||||0.034|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||This analysis focused specifically on the behavior control subscale. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.034
71839818|NCT06182033|143188190|OTHER|||||||0.099|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||These analyses use the Task Orientation subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.099
71795076|NCT03979638|143087051|SUPERIORITY||Estimated percent change|-28.1||||0.0005|TWO_SIDED|95.0|-39.5|-14.5|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-14.5|-39.5|0.0005
71795077|NCT03979638|143087051|SUPERIORITY||Estimated percent change|-28.4||||0.0003|TWO_SIDED|95.0|-39.7|-15.0|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.0|-39.7|0.0003
71795078|NCT03979638|143087051|SUPERIORITY||Estimated percent change|-29.5||||0.0014|TWO_SIDED|95.0|-42.7|-13.2|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-13.2|-42.7|0.0014
71795079|NCT03979638|143087051|SUPERIORITY||Estimated percent change|-32.4||||0.0006|TWO_SIDED|95.0|-45.3|-16.4|||Mixed Models Analysis|Intention To Treat (ITT), statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between BLU-5937 and placebo was estimated by 100 x \[e\^diff - 1\] where 'e' = exponent of difference; and 'diff' = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.4|-45.3|0.0006
71795080|NCT02586896|143087060|SUPERIORITY|||||||0.29|||||||ANOVA|||||||0.29
71795081|NCT02586896|143087062|SUPERIORITY|||||||0.91|||||||ANOVA|||||||0.91
71795082|NCT02586896|143087063|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
71795083|NCT02586896|143087064|SUPERIORITY|||||||0.54|||||||ANOVA|||||||0.54
71795084|NCT02678676|143087120|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.3444|TWO_SIDED|95.0|0.88|1.04||No adjustment to the p-value|Regression, Cox|||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.04|0.88|0.3444
71795085|NCT02678676|143087121|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.||1.16|0.83|
71795086|NCT00851799|143087134|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-4.7||||0.013|TWO_SIDED|97.5|-8.9|-0.4||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||-0.4|-8.9|0.013
71795087|NCT00851799|143087134|SUPERIORITY_OR_OTHER||Difference in annual rate of change|-2.8||||0.15|TWO_SIDED|97.5|-7.0|1.5||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.5|-7.0|0.15
71795088|NCT00851799|143087134|SUPERIORITY_OR_OTHER||Difference in annual rate of change|1.9||||0.31|TWO_SIDED|97.5|-2.4|6.2||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||6.2|-2.4|0.31
71839819|NCT06182033|143188190|OTHER|||||||0.209|||||||Regression, Linear|||This analysis used peer social skills subscale as the outcome in the model. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.||||.209
71839820|NCT06182033|143188191|OTHER|||||||0.82|||||||Multilevel Model|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.82
71839821|NCT06182033|143188192|OTHER|||||||0.67|||||||Multilevel Model|Kenward-Rogers and Restricted Maximum Likelihood adjustments in light of small sample size to reduce error likelihood.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.67
71839822|NCT06182033|143188193|OTHER|||||||0.024|||||||Regression, Linear|Kenward-Rogers and Restricted Maximum Likelihood to account for the small sample size.||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.024
71839823|NCT06182033|143188194|OTHER|||||||0.013|||||||Regression, Linear|Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood||We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.||||.013
71673421|NCT00460811|142864989|SUPERIORITY_OR_OTHER|||||||0.0002|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0002
71673422|NCT00460811|142864989|SUPERIORITY_OR_OTHER|||||||0.0036||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0036
71673423|NCT00460811|142864989|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||<0.0001
71673424|NCT00460811|142864989|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.||||0.0008
71795089|NCT00851799|143087135|SUPERIORITY_OR_OTHER||Difference in Change|0.24||||0.53|TWO_SIDED|97.5|-0.63|1.11||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||1.11|-0.63|0.53
71813331|NCT01181726|143129088|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.01|||||TWO_SIDED|90.0|94.54|101.6|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.60|94.54|
71839824|NCT05309291|143188207|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for λ FLC RR can be expressed as: Ho: μT-μR ≤ -3.783. The alternative hypothesis is expressed as: Ha: μT-μR \> -3.783 where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|16.99|STANDARD_DEVIATION|8.86|<|0.0001|TWO_SIDED|95.0|14.84|19.15|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the λ FLC RR at the mid-week treatment day dialysis session was assessed.||19.15|14.84|<0.0001
71813332|NCT01181726|143129089|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.87|||||TWO_SIDED|90.0|93.22|102.74|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.74|93.22|
71839825|NCT05309291|143188208|NON_INFERIORITY|The null hypothesis to demonstrate non-inferiority using a 10% margin for ß2-MG RR can be expressed as Ho: μT-μR ≤ -7.848. The alternative hypothesis is expressed as: Ha: μT-μR \> -7.848, where μT denotes the Theranova 400 treatment mean and μR denotes the FX 800 treatment mean.|Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|5.55|<|0.0001|TWO_SIDED|95.0|-2.54|0.16|||t-test, 2 sided|T-test was utilized to generate a two-sided 95% confidence interval (CI) for the difference in means.||Non-inferiority of the Theranova 400 Dialyzer compared to the FX 800 Dialyzer in regard to the β2-MG RR at the mid-week treatment day dialysis session was assessed.||0.16|-2.54|<0.0001
71839826|NCT01574274|143188261|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71673425|NCT02748356|142864996|OTHER|1 sample t-test|||||=|0.351|||||||t-test, 2 sided|This is a single group comparison||||||=0.351
71673426|NCT03515811|142865010|OTHER||Percentage and confidence interval|10.6|||||TWO_SIDED|95.0|5.0|19.2|||||95% CI: 5.0%-19.2%|||19.2|5.0|
71673427|NCT03515811|142865010|OTHER||Percentage and confidence interval|0.0|||||TWO_SIDED|95.0|0.0|7.0|||||95% CI: 0.0%-7.0%|||7.0|0.0|
71673428|NCT03515811|142865011|OTHER||Percentage and confidence interval|6.6|||||TWO_SIDED|95.0|3.1|12.2|||||95% CI: 3.1%-12.2%|||12.2|3.1|
71673429|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.37|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.002
71795090|NCT00851799|143087135|SUPERIORITY_OR_OTHER||Difference in Change (%)|-0.21||||0.53|TWO_SIDED|97.5|-0.98|0.55||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.||0.55|-0.98|0.53
71795091|NCT04920123|143087264|SUPERIORITY|||||||0.997||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.997
71795092|NCT04920123|143087265|SUPERIORITY|||||||0.5||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.500
71839827|NCT01574274|143188262|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Day 4 NSAA Level||||0.07
71839828|NCT01574274|143188262|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Day 11 NSAA Level||||0.29
71839829|NCT01574274|143188262|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||Day 18 NSAA Level||||0.0002
71839830|NCT01574274|143188262|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Day 25 NSAA Level||||<0.0001
71795093|NCT04920123|143087266|SUPERIORITY|||||||0.821||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.821
71795094|NCT04920123|143087267|SUPERIORITY|||||||0.995||||||The threshold for statistical significance was p=0.05|t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.995
71795095|NCT04920123|143087268|NON_INFERIORITY|Higher scores indicate more severe depression.||||||0.076|||||||t-test, 1 sided|||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.076
71795096|NCT04920123|143087269|SUPERIORITY|||||||0.432|||||||t-test, 1 sided|The threshold for statistical significance was p=0.05||Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||0.432
71795097|NCT04920123|143087270|SUPERIORITY|Null hypothesis: no improvement or worse with intervention Alternative hypothesis: improvement with intervention||||||0.75|||||||t-test, 1 sided|||||||0.750
71795098|NCT04064294|143087280|SUPERIORITY|||||||0.63||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.63
71795099|NCT04064294|143087281|SUPERIORITY|||||||0.09||||||the threshold for statistical significance was p = 0.05|ANOVA|degrees of freedom = 78||||||0.09
71795100|NCT04064294|143087282|SUPERIORITY|||||||0.011|||||||Chi-squared|threshold for significance is 0.05, degrees of freedom = 2||||||0.011
71839831|NCT01574274|143188262|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Week 7 NSAA Level||||<0.0001
71839832|NCT01574274|143188262|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Week 13 NSAA Level||||0.87
71893025|NCT02210780|143307183|SUPERIORITY||LS Mean Difference|-17.8|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|TWO_SIDED|90.0|-22.5|-13.1|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.||-13.1|-22.5|<0.0001
71893026|NCT02210780|143307185|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|90.0|-3.0|-1.7|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.||-1.7|-3.0|<0.0001
71893027|NCT02210780|143307186|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|90.0|-9.9|-6.6|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.||-6.6|-9.9|<0.0001
71795101|NCT04064294|143087283|SUPERIORITY|||||||0.033|||||||ANOVA|degrees of freedom = 75||||||0.033
71839833|NCT01574274|143188262|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Week 19 NSAA Level||||0.83
71839834|NCT01574274|143188262|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Week 25 NSAA Level||||0.94
71839835|NCT05089019|143188270|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.889|||||TWO_SIDED|94.12|0.81|0.976|||Mixed Models Analysis|Ratio of Geometric Least Square (LS) Mean||||0.976|0.810|
71839836|NCT05089019|143188271|EQUIVALENCE|Equivalence margin 80% to 125%.|Ratio of Geometric LS Mean|0.927|||||TWO_SIDED|94.12|0.882|0.975|||Mixed Models Analysis|||||0.975|0.882|
71839837|NCT05089019|143188272|EQUIVALENCE|Equivalence margin 80% to 125%|Ratio of Geometric LS Mean|0.891|||||TWO_SIDED|94.12|0.834|0.951|||Mixed Models Analysis|||||0.951|0.834|
71839838|NCT05530603|143188288|OTHER|||||||0.009||||||The threshold for statistical significance was p=0.05.|Chi-squared|||||||.009
71839839|NCT05530603|143188289|OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.8||0.73|TWO_SIDED|||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.730
71839840|NCT05530603|143188290|OTHER|||||||0.033||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||.033
71839841|NCT05530603|143188291|OTHER|||||||0.068|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||.068
71839842|NCT05530603|143188292|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|Fisher Exact|||||||.001
71839843|NCT05530603|143188293|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
71839844|NCT05530603|143188294|OTHER|||||||0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||.001
71839845|NCT02043678|143188295|SUPERIORITY||Hazard Ratio (HR)|1.122||||0.2636|TWO_SIDED|95.0|0.917|1.374|||Cox Proportional Hazards Model|||||1.374|0.917|0.2636
71839846|NCT02043678|143188296|SUPERIORITY||Hazard Ratio (HR)|1.151||||0.1194|TWO_SIDED|95.0|0.964|1.374|||Cox Proportional Hazards model|||||1.374|0.964|0.1194
71839847|NCT02043678|143188297|SUPERIORITY||Hazard Ratio (HR)|1.152||||0.1283|TWO_SIDED|95.0|0.96|1.383|||Cox Proportional Hazards Model|||||1.383|0.960|0.1283
71893028|NCT01773473|143307203|NON_INFERIORITY_OR_EQUIVALENCE|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.01|0.35||||||||0.35|-0.01|
71795102|NCT03450707|143087284|OTHER||Mean Difference (Final Values)|0.34||||0.72|TWO_SIDED|95.0|-1.82|2.5||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 24 hours.~Lactate imputed using a penalty (20pc increase) for patients who expired."|Mixed Models Analysis|P-value is for the comparison at 24 hours from the mixed model (i.e, not a global p-value)||||2.50|-1.82|0.72
71795103|NCT03450707|143087285|OTHER||Mean Difference (Final Values)|-0.38||||0.43|TWO_SIDED|95.0|-1.34|0.58|||Regression, Linear|||As AUC-VO2s turned out to be normally distributed, we used a linear regression model to compare mean AUC-VO2s between treatment groups controlling for average temperature.||0.58|-1.34|0.43
71795104|NCT03450707|143087286|OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test, testing the null hypothesis that there is no difference in the distribution of 72-hour lactates between thiamine and placebo groups.|No parameter estimated other than p-value = 0.88 from Wilcoxon rank-sum test.|||0.88
71795105|NCT03450707|143087287|OTHER||Mean Difference (Final Values)|0.4||||0.072|TWO_SIDED|95.0|0.01|0.8||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH specific activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||0.80|0.01|0.072
71795106|NCT03450707|143087288|OTHER||Mean Difference (Final Values)|2.4||||0.044|TWO_SIDED|95.0|0.1|4.7||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH activity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||4.7|0.1|0.044
71795107|NCT03450707|143087289|OTHER||Mean Difference (Final Values)|-48.5||||0.828|TWO_SIDED|95.0|-297.0|200.0||Mixed model controlling for repeated measures within patients used to get a mean difference in PDH quantity between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||200.0|-297.0|0.828
71795108|NCT03450707|143087292|OTHER||Mean Difference (Final Values)|2.34||||0.1|TWO_SIDED|95.0|0.47|4.22||Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model.||||4.22|0.47|0.10
71839848|NCT02043678|143188298|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.1669|TWO_SIDED|95.0|0.945|1.389|||Cox Proportional Hazards Model|||||1.389|0.945|0.1669
71839849|NCT02043678|143188299|SUPERIORITY||Hazard Ratio (HR)|1.033||||0.7871|TWO_SIDED|95.0|0.816|1.308|||Cox Proportional Hazards Model|||||1.308|0.816|0.7871
71839850|NCT02043678|143188300|SUPERIORITY||Hazard Ratio (HR)|1.126||||0.2467|TWO_SIDED|95.0|0.921|1.378|||Cox Proportional Hazards Model|||||1.378|0.921|0.2467
71839851|NCT03216057|143188321|SUPERIORITY|The sample size was calculated that 130 subjects randomized in a 1:1 fashion between the 2 arms have 85% power to detect a difference of at least 20% in triglyceride percentage changes compared with placebo at week 12, assuming a common standard deviation in percentage change of 35%, a 2-sided α = 0.05, and we add 20% for lost follow-up, finally the number of subjects for each arm was 65.|Mean Difference (Net)|-24.5|||<|0.01|TWO_SIDED|95.0|-32.7|-16.2|||t-test, 2 sided|||||-16.2|-32.7|<0.01
71839852|NCT03216057|143188322|SUPERIORITY||Mean Difference (Net)|-59.9|||<|0.01|TWO_SIDED|95.0|-83.0|-36.8|||t-test, 2 sided|||||-36.8|-83.0|<0.01
71893029|NCT01440101|143307251|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Mann-Whitney U test stratified by the presence or absence of Gd+ lesions at baseline.|Wilcoxon (Mann-Whitney)|||||||<0.001
71893030|NCT01440101|143307254|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value obtained from the Van Elteren test stratified by the presence or absence of Gd+ lesions at baseline.|Van Elteren test|||||||<0.001
71893031|NCT01440101|143307255|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon rank sum test|||||||0.006
71893032|NCT01440101|143307256|SUPERIORITY_OR_OTHER||Difference in proportions|0.404|||<|0.001|TWO_SIDED|95.0|0.223|0.586|||Fisher Exact|||Relapse-free proportions compared using a two-sided Fisher exact test. In the analysis, participants with unknown status are considered to have relapsed.||0.586|0.223|<0.001
71795109|NCT03450707|143087294|OTHER||Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-3.6|1.6||Mixed model controlling for repeated measures within patients used to get a mean difference in Basal Respiration between the thiamine and placebo groups at 24 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.|Mean difference uses a non-logged version of the variable.|||1.6|-3.6|0.43
71839853|NCT03216057|143188323|SUPERIORITY||Mean Difference (Net)|-9.0||||0.01|TWO_SIDED|95.0|-16.1|-1.9|||t-test, 2 sided|||||-1.9|-16.1|0.01
71839854|NCT03216057|143188324|SUPERIORITY||Mean Difference (Net)|-4.9||||0.3|TWO_SIDED|95.0|-15.8|6.05|||t-test, 2 sided|||||6.05|-15.8|0.3
71839855|NCT03216057|143188325|SUPERIORITY||Mean Difference (Net)|-12.4|||<|0.01|TWO_SIDED|95.0|-21.2|-3.5|||t-test, 2 sided|||||-3.5|-21.2|<0.01
71839856|NCT03216057|143188326|SUPERIORITY||Mean Difference (Net)|-2.2||||0.02|TWO_SIDED|95.0|-4.1|-0.3|||t-test, 2 sided|||||-0.3|-4.1|0.02
71839857|NCT03216057|143188327|SUPERIORITY||Mean Difference (Net)|-1.2||||0.6|TWO_SIDED|95.0|-6.3|3.8|||t-test, 2 sided|||||3.8|-6.3|0.6
71839858|NCT03216057|143188328|SUPERIORITY||Mean Difference (Net)|1.9||||0.1|TWO_SIDED|95.0|-0.9|4.9|||t-test, 2 sided|||||4.9|-0.9|0.1
71839859|NCT03216057|143188329|SUPERIORITY||Mean Difference (Net)|13.4|||<|0.01|TWO_SIDED|95.0|5.8|21.0|||t-test, 2 sided|||||21|5.8|<0.01
71839860|NCT03216057|143188330|SUPERIORITY||Mean Difference (Net)|0.8|||<|0.01|TWO_SIDED|95.0|0.4|1.2|||t-test, 2 sided|||||1.2|0.4|<0.01
71893033|NCT01440101|143307257|SUPERIORITY_OR_OTHER|||||||0.729||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline to Week 12||||0.729
71893034|NCT01440101|143307257|SUPERIORITY_OR_OTHER|||||||0.942||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline at Week 24||||0.942
71795110|NCT03450707|143087295|OTHER||Mean Difference (Final Values)|0.76||||0.02|TWO_SIDED|95.0|-0.27|1.78||Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.|Mixed Models Analysis|P-value is the global p-value from the mixed model. P-value is obtained from a model that uses a log-transformed version of the variable.||||1.78|-0.27|0.02
71795111|NCT00481195|143087297|SUPERIORITY_OR_OTHER|||||||0.0439||95.0|||||ANOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.||||0.0439
71795112|NCT00481195|143087298|SUPERIORITY_OR_OTHER|||||||0.0795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0795
71795113|NCT00481195|143087299|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0272
71795114|NCT00481195|143087300|SUPERIORITY_OR_OTHER|||||||0.0802||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0802
71795115|NCT00481195|143087301|SUPERIORITY_OR_OTHER|||||||0.2407||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2407
71795116|NCT00481195|143087302|SUPERIORITY_OR_OTHER|||||||0.0502||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0502
71795117|NCT00481195|143087303|SUPERIORITY_OR_OTHER|||||||0.0612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0612
71795118|NCT00481195|143087304|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.1980
71795119|NCT00481195|143087305|SUPERIORITY_OR_OTHER|||||||0.896||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.8960
71795120|NCT00481195|143087306|SUPERIORITY_OR_OTHER|||||||0.2575||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.2575
71795121|NCT00481195|143087307|SUPERIORITY_OR_OTHER|||||||0.3129||95.0||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel|||||||0.3129
71795122|NCT00481195|143087308|SUPERIORITY_OR_OTHER|||||||0.1565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1565
71795123|NCT00481195|143087309|SUPERIORITY_OR_OTHER|||||||0.6737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6737
71795124|NCT00481195|143087310|SUPERIORITY_OR_OTHER|||||||0.2249||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2249
71795125|NCT00481195|143087311|SUPERIORITY_OR_OTHER|||||||0.0862||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0862
71795126|NCT00481195|143087312|SUPERIORITY_OR_OTHER|||||||0.9281||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9281
71795127|NCT00481195|143087313|SUPERIORITY_OR_OTHER|||||||0.4428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.4428
71795128|NCT00481195|143087314|SUPERIORITY_OR_OTHER|||||||0.0965||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0965
71795129|NCT00481195|143087315|SUPERIORITY_OR_OTHER|||||||0.5389||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5389
71795130|NCT00481195|143087316|SUPERIORITY_OR_OTHER|||||||0.0793||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0793
71893035|NCT00636818|143307271|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
71893036|NCT00636818|143307272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
71795131|NCT00481195|143087317|SUPERIORITY_OR_OTHER|||||||0.3814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3814
71893037|NCT00636818|143307273|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
71795132|NCT00481195|143087318|SUPERIORITY_OR_OTHER|||||||0.8099||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.8099
71795133|NCT00481195|143087319|SUPERIORITY_OR_OTHER|||||||0.0968||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0968
71795134|NCT00481195|143087320|SUPERIORITY_OR_OTHER|||||||0.1605||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1605
71795135|NCT00481195|143087321|SUPERIORITY_OR_OTHER|||||||0.1869||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.1869
71795136|NCT00481195|143087322|SUPERIORITY_OR_OTHER|||||||0.0817||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.0817
71795137|NCT00481195|143087323|SUPERIORITY_OR_OTHER|||||||0.3712||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3712
71795138|NCT00481195|143087324|SUPERIORITY_OR_OTHER|||||||0.5427||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.5427
71795139|NCT00481195|143087325|SUPERIORITY_OR_OTHER|||||||0.3463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.3463
71795140|NCT00481195|143087326|SUPERIORITY_OR_OTHER|||||||0.273||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.2730
71795141|NCT00481195|143087327|SUPERIORITY_OR_OTHER|||||||0.7791||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.7791
71795142|NCT00481195|143087328|SUPERIORITY_OR_OTHER|||||||0.9007||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.9007
71795143|NCT00481195|143087329|SUPERIORITY_OR_OTHER|||||||0.6431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.||||0.6431
71795144|NCT00481195|143087330|SUPERIORITY_OR_OTHER|||||||0.6631||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder.||||||0.6631
71795145|NCT00481195|143087331|SUPERIORITY_OR_OTHER|||||||0.9768||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.9768
71795146|NCT00481195|143087332|SUPERIORITY_OR_OTHER|||||||0.9873||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment fro bipolar disorder||||||0.9873
71795147|NCT00481195|143087333|SUPERIORITY_OR_OTHER|||||||0.4567||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4567
71795148|NCT00481195|143087334|SUPERIORITY_OR_OTHER|||||||0.6475||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.6475
71795149|NCT00481195|143087335|SUPERIORITY_OR_OTHER|||||||0.5066||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.5066
71795150|NCT00481195|143087336|SUPERIORITY_OR_OTHER|||||||0.4438||95.0|||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder||||||0.4438
71795151|NCT03343483|143087337|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|1.06||0.896|TWO_SIDED|95.0|-2.21|1.93|||Mixed Models Analysis|||||1.93|-2.21|.896
71893038|NCT00636818|143307274|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.013
71795152|NCT03343483|143087338|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.8|TWO_SIDED||||||ANOVA|||||||0.80
71795153|NCT03343483|143087339|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.33|TWO_SIDED||||||Mixed Models Analysis|||||||0.33
71795154|NCT03343483|143087340|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
71795155|NCT03343483|143087341|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.73|TWO_SIDED||||||Mixed Models Analysis|||||||0.73
71795156|NCT03343483|143087342|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.57|TWO_SIDED||||||Mixed Models Analysis|||||||0.57
71893039|NCT00636818|143307275|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
71893040|NCT00636818|143307276|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
71893041|NCT00636818|143307276|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Color Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.005
71673430|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.28|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mastoid Process right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.018
71673431|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.32|||=|0.02|TWO_SIDED|||||The above p value corresponds to the Bladder 10 left (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 left (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.020
71673432|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.39|||=|0.025|TWO_SIDED|||||The above p value corresponds to the Bladder 10 right (BL 10) algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Bladder 10 right (BL 10) algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.025
71673433|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.55|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
71673434|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.57|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Zygapophyseal Joint right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||<0.001
71673435|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.36|||=|0.139|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.139
71795157|NCT02932904|143087349|SUPERIORITY||Least square (LS) Mean Difference|2.74|STANDARD_ERROR_OF_MEAN|1.04||0.009|TWO_SIDED|95.0|0.69|4.78||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||4.78|0.69|0.009
71795158|NCT02932904|143087349|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.017||0.303|TWO_SIDED|95.0|-0.95|3.05||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.05|-0.95|0.303
71795159|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.627||0.072|TWO_SIDED|95.0|-0.1|2.37|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.37|-0.10|0.072
71795160|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|1.29|STANDARD_ERROR_OF_MEAN|0.612||0.035|TWO_SIDED|95.0|0.09|2.5|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.50|0.09|0.035
71795161|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.846||0.149|TWO_SIDED|95.0|-0.44|2.89|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.89|-0.44|0.149
71893042|NCT00636818|143307276|SUPERIORITY_OR_OTHER|||||||0.144||95.0||||P-value for Color-Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.144
71795162|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.828||0.303|TWO_SIDED|95.0|-0.78|2.48|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.48|-0.78|0.303
71795163|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.906||0.028|TWO_SIDED|95.0|0.22|3.78|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.78|0.22|0.028
71795164|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.886||0.645|TWO_SIDED|95.0|-1.33|2.15|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.15|-1.33|0.645
71893043|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.791||95.0||||P-value for Physical Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.791
71893044|NCT00636818|143307277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
71673436|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.3|||=|0.011|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Upper Trapezius Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.011
71795165|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.943||0.043|TWO_SIDED|95.0|0.06|3.77|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.77|0.06|0.043
71795166|NCT02932904|143087350|SUPERIORITY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.923||0.465|TWO_SIDED|95.0|-1.14|2.49|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||2.49|-1.14|0.465
71795167|NCT02932904|143087351|SUPERIORITY||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.616||0.009|TWO_SIDED|95.0|-2.84|-0.41|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.41|-2.84|0.009
71795168|NCT02932904|143087351|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.834||0.123|TWO_SIDED|95.0|-2.93|0.35|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.35|-2.93|0.123
71795169|NCT02932904|143087351|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|0.892||0.039|TWO_SIDED|95.0|-3.61|-0.1|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.10|-3.61|0.039
71795170|NCT02932904|143087351|SUPERIORITY||LS Mean Difference|-2.49|STANDARD_ERROR_OF_MEAN|0.929||0.008|TWO_SIDED|95.0|-4.32|-0.66|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.66|-4.32|0.008
71795171|NCT02932904|143087351|SUPERIORITY||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|1.024||0.007|TWO_SIDED|95.0|-4.78|-0.75|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.75|-4.78|0.007
71795172|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.612||0.419|TWO_SIDED|95.0|-1.7|0.71|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.71|-1.70|0.419
71795173|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.6||0.581|TWO_SIDED|95.0|-1.51|0.85|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.85|-1.51|0.581
71795174|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.828||0.938|TWO_SIDED|95.0|-1.69|1.56|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.56|-1.69|0.938
71795175|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.814||0.592|TWO_SIDED|95.0|-2.04|1.17|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.17|-2.04|0.592
71795176|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.886||0.87|TWO_SIDED|95.0|-1.6|1.89|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.89|-1.60|0.870
71893045|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Physical Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.037
71795177|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.871||0.098|TWO_SIDED|95.0|-3.16|0.27|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.27|-3.16|0.098
71795178|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.923||0.532|TWO_SIDED|95.0|-2.39|1.24|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.24|-2.39|0.532
71795179|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.907||0.046|TWO_SIDED|95.0|-3.6|-0.03|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||-0.03|-3.60|0.046
71795180|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.018||0.977|TWO_SIDED|95.0|-2.03|1.97|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||1.97|-2.03|0.977
71795181|NCT02932904|143087352|SUPERIORITY||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.0||0.087|TWO_SIDED|95.0|-3.68|0.25|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||0.25|-3.68|0.087
71795182|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.515|TWO_SIDED|95.0|0.037|5.201|||Regression, Logistic|||Week 1||5.201|0.037|0.515
71893046|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.446||95.0||||P-value for Role-Physical: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.446
71893047|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.365||95.0||||P-value for Bodily Pain: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.365
71795183|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.59||||0.677|TWO_SIDED|95.0|0.049|7.051|||Regression, Logistic|||Week 1||7.051|0.049|0.677
71795184|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.47||||0.72|TWO_SIDED|95.0|0.181|11.912|||Regression, Logistic|||Week 1||11.912|0.181|0.720
71795185|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.65||||0.732|TWO_SIDED|95.0|0.053|7.861|||Regression, Logistic|||Week 1||7.861|0.053|0.732
71795186|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.87||||0.913|TWO_SIDED|95.0|0.066|11.303|||Regression, Logistic|||Week 1||11.303|0.066|0.913
71795187|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.37||||0.164|TWO_SIDED|95.0|0.09|1.507|||Regression, Logistic|||Week 2||1.507|0.090|0.164
71795188|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.25||||0.098|TWO_SIDED|95.0|0.05|1.287|||Regression, Logistic|||Week 2||1.287|0.050|0.098
71795189|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.2||||0.758|TWO_SIDED|95.0|0.383|3.731|||Regression, Logistic|||Week 2||3.731|0.383|0.758
71795190|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.256|TWO_SIDED|95.0|0.107|1.814|||Regression, Logistic|||Week 2||1.814|0.107|0.256
71795191|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.3||||0.154|TWO_SIDED|95.0|0.059|1.561|||Regression, Logistic|||Week 2||1.561|0.059|0.154
71795192|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.36||||0.16|TWO_SIDED|95.0|0.087|1.497|||Regression, Logistic|||Week 3||1.497|0.087|0.160
71795193|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.744|TWO_SIDED|95.0|0.252|2.679|||Regression, Logistic|||Week 3||2.679|0.252|0.744
71795194|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.43||||0.194|TWO_SIDED|95.0|0.636|9.317|||Regression, Logistic|||Week 3||9.317|0.636|0.194
71795195|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.88||||0.871|TWO_SIDED|95.0|0.181|4.261|||Regression, Logistic|||Week 3||4.261|0.181|0.871
71795196|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.0||||0.329|TWO_SIDED|95.0|0.497|8.037|||Regression, Logistic|||Week 3||8.037|0.497|0.329
71795197|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.42||||0.187|TWO_SIDED|95.0|0.119|1.514|||Regression, Logistic|||Week 4||1.514|0.119|0.187
71795198|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.729|TWO_SIDED|95.0|0.273|2.476|||Regression, Logistic|||Week 4||2.476|0.273|0.729
71839861|NCT04568603|143188331|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the 90% CI for the geometric mean ratio (GMR) of methadone+ ISL to methadone alone is contained within the interval (0.70, 1.43).|GMR|1.03|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
71839862|NCT04568603|143188332|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
71893048|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||P-value for General Health Perception: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.087
71673437|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.67|||=|0.01|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.010
71673438|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.62|||=|0.06|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Levator Scapulae Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.06
71673439|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.51|||=|0.05|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.050
71673440|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.41|||=|0.068|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Deltoid Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.068
71673441|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.59|||=|0.049|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle left algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.049
71673442|NCT05870371|142865056|OTHER||Mean Difference (Net)|0.73|||=|0.004|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Tibialis Anterior Muscle right algometric site.|Null hypothesis: The application of ATM does not affect the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain (main hypothesis).||||=0.004
71795199|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.71||||0.133|TWO_SIDED|95.0|0.739|9.917|||Regression, Logistic|||Week 4||9.917|0.739|0.133
71795200|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.266|4.961|||Regression, Logistic|||Week 4||4.961|0.266|0.852
71795201|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.23||||0.24|TWO_SIDED|95.0|0.585|8.472|||Regression, Logistic|||Week 4||8.472|0.585|0.240
71795202|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.55||||0.317|TWO_SIDED|95.0|0.166|1.789|||Regression, Logistic|||Week 5||1.789|0.166|0.317
71795203|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.79|TWO_SIDED|95.0|0.41|3.233|||Regression, Logistic|||Week 5||3.233|0.410|0.790
71795204|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|3.64||||0.073|TWO_SIDED|95.0|0.888|14.911|||Regression, Logistic|||Week 5||14.911|0.888|0.073
71795205|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.98||||0.371|TWO_SIDED|95.0|0.442|8.902|||Regression, Logistic|||Week 5||8.902|0.442|0.371
71795206|NCT02932904|143087353|SUPERIORITY|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|4.19||||0.046|TWO_SIDED|95.0|1.027|17.063|||Regression, Logistic|||Week 5||17.063|1.027|0.046
71893049|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||P-value for Vitality: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.043
71795207|NCT02932904|143087356|SUPERIORITY||LS Mean Difference|3.38|STANDARD_ERROR_OF_MEAN|1.082||0.002|TWO_SIDED|95.0|1.25|5.51||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.51|1.25|0.002
71795208|NCT02932904|143087356|SUPERIORITY||LS Mean Difference|1.63|STANDARD_ERROR_OF_MEAN|1.068||0.129|TWO_SIDED|95.0|-0.47|3.73||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||3.73|-0.47|0.129
71795209|NCT02932904|143087357|SUPERIORITY||LS Mean Difference|4.31|STANDARD_ERROR_OF_MEAN|1.078|<|0.001|TWO_SIDED|95.0|2.19|6.43||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||6.43|2.19|<0.001
71795210|NCT02932904|143087357|SUPERIORITY||LS Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|1.072||0.005|TWO_SIDED|95.0|0.95|5.17||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.||5.17|0.95|0.005
71795211|NCT01289847|143087382|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||one-sample Poisson rate|||For the primary efficacy analysis, the SABI rate for GAMMAPLEX and the upper bound of its one-sided 99% confidence interval (CI) were estimated by using the exact method for a one-sample Poisson rate.||||0.01
71795212|NCT01289847|143087383|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|99.0|||||one-sample Poisson method|||||||0.01
71839863|NCT04568603|143188333|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 1.43.|GMR|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.96|
71839864|NCT04568603|143188334|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.06|||||TWO_SIDED|90.0|1.03|1.1||||||||1.10|1.03|
71839865|NCT04568603|143188336|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.94|1.09||||||||1.09|0.94|
71839866|NCT04568603|143188337|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.08|||||TWO_SIDED|90.0|1.04|1.13||||||||1.13|1.04|
71839867|NCT04568603|143188339|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.03|||||TWO_SIDED|90.0|0.99|1.07||||||||1.07|0.99|
71893050|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for Social Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.086
71795213|NCT05876273|143087388|OTHER|The statistical analysis included general linear models (GLM), with repeated measures (NAP vs UMPC) and a covariate the 1-hour average CGM level prior to initiating either controller. This covariate was used to compute the adjusted performance differences between NAP and UMPC. The data was analyzed using the GLM procedures of IBM SPSS 28.0.||||||0.2||||||1-hour average CGM level prior to initiating either controller was included as a covariate in the analysis. This covariate was used to compute the adjusted performance differences between NAP and UMPC.|GLM with Repeated Measures|General linear models (GLM), with repeated measures (NAP vs UMPC)||||||0.2
71795214|NCT03975647|143087393|OTHER||Hazard Ratio (HR)|0.759||||0.0163|TWO_SIDED|95.0|0.607|0.95|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.950|0.607|0.0163
71795215|NCT03975647|143087395|OTHER||Hazard Ratio (HR)|0.639||||0.0078|TWO_SIDED|95.0|0.459|0.891|||Log Rank||HR was calculated from Cox proportional hazards model. (line of treatment for metastatic: first versus \[vs\] other; hormone receptor status: negative vs positive; presence or history of brain metastases: yes vs no; ECOG status: 0,1 at randomization.|||0.891|0.459|0.0078
71795216|NCT03975647|143087396|OTHER|||||||0.2055|||||||Cochran-Mantel-Haenszel|||||||0.2055
71795217|NCT02872116|143087406|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|98.4|0.59|0.86|||Log Rank|||||0.86|0.59|<0.0001
71839868|NCT04568603|143188340|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
71839869|NCT04568603|143188341|EQUIVALENCE|The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.|GMR|1.07|||||TWO_SIDED|90.0|1.03|1.11||||||||1.11|1.03|
71893051|NCT00636818|143307277|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value for Role-Emotional: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||0.010
71893052|NCT00636818|143307277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided|||||||<0.001
71893053|NCT01658514|143307297|SUPERIORITY_OR_OTHER||% Ratio of LS Means|51.5||||0.0011|TWO_SIDED|90.0|37.77|70.23||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||70.23|37.77|0.0011
71673443|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|0.03|=|0.297|TWO_SIDED|||||The above p value corresponds to the Mastoid Process left algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.297
71758445|NCT02420821|143019167|SUPERIORITY||LS Mean Difference|0.5||||0.7725|TWO_SIDED|95.0|-2.9|3.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||3.91|-2.90|0.7725
71758446|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.49||||0.001|TWO_SIDED|95.0|-0.77|-0.2|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.20|-0.77|0.0010
71758447|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.34|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.34|-0.91|<0.0001
71758448|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.91|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.69|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.69|-1.13|<0.0001
71758449|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.52||||0.0002|TWO_SIDED|95.0|-0.79|-0.25|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.25|-0.79|0.0002
71758450|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.84|-0.29|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.29|-0.84|<0.0001
71758451|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.32|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.32|-0.81|<0.0001
71758452|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.33||||0.0036|TWO_SIDED|95.0|-0.56|-0.11|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.11|-0.56|0.0036
71758453|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.91|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.91|-1.46|<0.0001
71758454|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.54||||0.0001|TWO_SIDED|95.0|-0.81|-0.27|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.27|-0.81|0.0001
71758455|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.71|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.71|-1.28|<0.0001
71795218|NCT02872116|143087407|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|98.0|0.56|0.81|||Log Rank|||||0.81|0.56|<0.0001
71795219|NCT03552575|143087438|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.19|TWO_SIDED|95.0|-4.8|1.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||1.0|-4.8|0.19
71795220|NCT03552575|143087439|SUPERIORITY||Ratio of adjusted geometric means|0.85||||0.31|TWO_SIDED|95.0|0.63|1.16|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.16|0.63|0.31
71795221|NCT03552575|143087440|SUPERIORITY||Ratio of adjusted geometric means|0.87||||0.41|TWO_SIDED|95.0|0.62|1.22|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, and use of diuretics at baseline||||1.22|0.62|0.41
71795222|NCT03552575|143087441|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.1|TWO_SIDED|95.0|-6.8|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-6.8|0.10
71795223|NCT03552575|143087442|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.29|TWO_SIDED|95.0|-6.6|2.0|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||2.0|-6.6|0.29
71795224|NCT03552575|143087443|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.46|TWO_SIDED|95.0|-2.0|0.9|||Regression, Linear|adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.9|-2.0|0.46
71839870|NCT04564742|143188345|SUPERIORITY||Win Ratio (WR)|1.34|||<|0.001|TWO_SIDED|95.0|1.2|1.5||A closed testing procedure including a pre-specified hierarchical ordering of the primary and secondary endpoints was utilised. No multiplicity control was placed on the exploratory endpoints.|Win Ratio Analysis|||The primary objective of the study was to determine if the clinical benefit of dapagliflozin was superior as compared with placebo, utilizing a hierarchical composite endpoint and win-ratio (WR) method. With a presumed WR of 1.20, 4000 patients were provide an 80% statistical power for the primary endpoint, maintaining a 1:1 allocation between treatments. The primary analysis was based on the intention-to-treat principle using the Full Analysis Set.||1.50|1.20|<0.001
71839871|NCT03313076|143188353|SUPERIORITY||Slope|-0.84||||0.276|TWO_SIDED|95.0|-2.32|0.63||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||0.63|-2.32|0.276
71839872|NCT03313076|143188353|SUPERIORITY||Slope|0.72||||0.336|TWO_SIDED|95.0|-0.71|2.14||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||||2.14|-0.71|0.336
71839873|NCT03313076|143188353|SUPERIORITY||Slope|-2.33||||0.004|TWO_SIDED|95.0|-3.76|-0.9||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||-0.9|-3.76|0.004
71839874|NCT03313076|143188353|SUPERIORITY||Slope|0.92||||0.139|TWO_SIDED|95.0|-0.25|2.09||"The final, adjusted p-value threshold of 0.0492, using the O'Brien-Fleming approach, allows for a statistical penalty to be assessed because of the interim analysis."|Mixed Models Analysis|The model was adjusted for age, sex, race, treatment interaction, initial pain severity, and total body surface area burned.||Sensitivity analysis adjusting for an influential observation (using the dfbeta approach) that could produce spurious results from a small trial dataset||2.09|-0.25|0.139
71839875|NCT05448105|143188398|SUPERIORITY|||||||0.02|||||||Wilcoxon signed rank test|"Wilcoxon signed rank test comparing the participants' SUS scores to the threshold value of 71 indicative of good usability."||||||0.02
71893054|NCT01658514|143307297|SUPERIORITY_OR_OTHER||% Ratio of LS Means|73.8||||0.0733|TWO_SIDED|90.0|55.97|97.43||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||97.43|55.97|0.0733
71795225|NCT03552575|143087444|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.16|TWO_SIDED|95.0|-3.5|0.6|||Regression, Linear|Adjusted for randomized treatment, baseline value of the outcome, use of diuretics at baseline and time from randomization to cardiac MRI||||0.6|-3.5|0.16
71795226|NCT03552575|143087445|SUPERIORITY|||||||0.56|||||||Fisher Exact|||||||0.56
71795227|NCT03792672|143087446|SUPERIORITY||Least square mean (LSM) difference|115.0|STANDARD_ERROR_OF_MEAN|144.0||0.4278|TWO_SIDED|90.0|-128.0|359.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||359|-128|0.4278
71795228|NCT03792672|143087446|SUPERIORITY||LSM difference|338.0|STANDARD_ERROR_OF_MEAN|147.0||0.0269|TWO_SIDED|90.0|90.5|585.0||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||585|90.5|0.0269
71839876|NCT05448105|143188401|OTHER|||||||0.04|||||||paired Wilcoxon signed-rank sum test|||||||0.04
71839877|NCT05448105|143188402|OTHER||||||<|0.01||||||This is calculated p-value. The threshold for significance was less than 0.05.|paired Wilcoxon signed-rank sum test|||||||<0.01
71839878|NCT05448105|143188403|OTHER|||||||0.16|||||||paired Wilcoxon signed-rank sum test|||||||0.16
71839879|NCT05448105|143188404|OTHER|||||||0.69|||||||paired Wilcoxon signed-rank sum test|||||||0.69
71839880|NCT05448105|143188405|OTHER|||||||0.9|||||||paired Wilcoxon signed-rank sum test|||||||0.90
71839881|NCT05448105|143188406|OTHER|||||||0.11|||||||paired Wilcoxon signed-rank sum test|||||||0.11
71839882|NCT05448105|143188407|OTHER|||||||0.22|||||||paired Wilcoxon signed-rank sum test|||||||0.22
71839883|NCT05448105|143188408|OTHER|||||||1||||||This is the calculated p-value.|McNemar|||Analysis for pre-post change in knowledge of definition of A1C||||1.00
71673444|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|=|0.855|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value correspond to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mastoid Process right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.855
71673445|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.594|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.594
71673446|NCT05870371|142865056|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.02|=|0.929|TWO_SIDED|||||The above p value corresponds to the Bladder 10 (BL 10) right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Bladder 10 (BL 10) right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.929
71673447|NCT05870371|142865056|OTHER||Dependence coefficient (β)|0.002|STANDARD_ERROR_OF_MEAN|0.05|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
71795229|NCT03792672|143087447|SUPERIORITY||LSM difference|-0.388|STANDARD_ERROR_OF_MEAN|0.582||0.5089|TWO_SIDED|90.0|-1.37|0.595||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.595|-1.37|0.5089
71795230|NCT03792672|143087447|SUPERIORITY||LSM difference|-0.209|STANDARD_ERROR_OF_MEAN|0.581||0.7208|TWO_SIDED|90.0|-1.19|0.773||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||||0.773|-1.19|0.7208
71795231|NCT03792672|143087448|SUPERIORITY||LSM difference|14.0|STANDARD_ERROR_OF_MEAN|17.1||0.4174|TWO_SIDED|90.0|-14.8|42.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||42.8|-14.8|0.4174
71795232|NCT03792672|143087448|SUPERIORITY||LSM difference|15.1|STANDARD_ERROR_OF_MEAN|17.1||0.3832|TWO_SIDED|90.0|-25.3|31.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 50 ms peak-to-peak amplitude||31.5|-25.3|0.3832
71795233|NCT03792672|143087448|SUPERIORITY||LSM difference|-0.326|STANDARD_ERROR_OF_MEAN|4.09||0.9368|TWO_SIDED|90.0|-7.23|6.58||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||6.58|-7.23|0.9368
71839884|NCT05448105|143188408|OTHER|||||||0.55|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.||||0.55
71839885|NCT05448105|143188408|OTHER|||||||0.11|||||||McNemar|||Analysis for pre-post change in knowledge of definition of systolic blood pressure||||0.11
71839886|NCT05448105|143188408|OTHER|||||||0.63|||||||McNemar|||Analysis of pre-post change in knowledge of goal range for systolic blood pressure||||0.63
71839887|NCT05448105|143188408|OTHER|||||||0.12|||||||McNemar|||Analysis of pre-post change in knowledge of definition of LDL cholesterol||||0.12
71893055|NCT01658514|143307297|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.7||||0.0028|TWO_SIDED|90.0|42.25|76.1||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||76.10|42.25|0.0028
71839888|NCT05448105|143188408|OTHER|||||||0.33|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for LDL cholesterol||||0.33
71839889|NCT05448105|143188408|OTHER|||||||0.23|||||||McNemar|||Analysis of pre-post change in knowledge of definition of urine microalbumin||||0.23
71839890|NCT05448105|143188408|OTHER|||||||0.58|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for urine microalbumin||||0.58
71839891|NCT05448105|143188408|OTHER|||||||1|||||||McNemar|||Analysis of pre-post change in knowledge of definition of body mass index (BMI)||||1.00
71839892|NCT05448105|143188408|OTHER|||||||0.27|||||||McNemar|||Analysis for pre-post change in knowledge of goal range for body mass index (BMI)||||0.27
71839893|NCT05270408|143188410|SUPERIORITY||Cohen's d|0.93||||0.25|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.25
71839894|NCT05270408|143188410|SUPERIORITY||Cohen's d|0.69||||0.18|TWO_SIDED||||||ANCOVA|||RAVLT Total Learning||||0.18
71839895|NCT05270408|143188410|SUPERIORITY||Cohen's d|0.74||||0.48|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.48
71839896|NCT05270408|143188410|SUPERIORITY||Cohen's d|0.19||||0.64|TWO_SIDED||||||ANCOVA|||RAVLT Delayed||||0.64
71839897|NCT05270408|143188411|SUPERIORITY||Cohen's d|0.03||||0.98|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.98
71839898|NCT05270408|143188411|SUPERIORITY||Cohen's d|0.86||||0.22|TWO_SIDED||||||ANCOVA|||BVMT total learning||||0.22
71839899|NCT05270408|143188411|SUPERIORITY||Cohen's d|0.04||||0.97|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.97
71839900|NCT05270408|143188411|SUPERIORITY||Cohen's d|0.69||||0.23|TWO_SIDED||||||ANCOVA|||BVMT delayed||||0.23
71839901|NCT05270408|143188412|SUPERIORITY||Cohen's d|0.04||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
71839902|NCT05270408|143188412|SUPERIORITY||Cohen's d|0.42||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
71839903|NCT05270408|143188413|SUPERIORITY||Cohen's d|1.49||||0.06|TWO_SIDED||||||ANCOVA|||||||0.06
71839904|NCT05270408|143188413|SUPERIORITY||Cohen's d|1.08||||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
71839905|NCT05270408|143188414|SUPERIORITY||Cohen's d|0.19||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
71839906|NCT05270408|143188414|SUPERIORITY||Cohen's d|0.68||||0.38|TWO_SIDED||||||ANCOVA|||||||0.38
71839907|NCT05270408|143188416|SUPERIORITY||Cohen's d|0.96||||0.11|TWO_SIDED||||||ANCOVA|||||||0.11
71839908|NCT05270408|143188416|SUPERIORITY|||||||0.68|||||||ANCOVA||||Eta2 effect sizes produced from the pairwise comparisons were transformed to Cohen's d for examination of effect sizes. A small/weak effect size was demonstrated (Cohen's d = 0.10), when adjusting for baseline performance.|||0.68
71839909|NCT02465268|143188419|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.196|TWO_SIDED|95.0|0.77|2.16|||Log Rank|||||2.16|0.77|0.196
71839910|NCT02465268|143188419|SUPERIORITY||Hazard Ratio (HR)|1.63||||0.196|TWO_SIDED|95.0|0.99|2.7|||Log Rank|||||2.70|0.99|0.196
71839911|NCT02465268|143188420|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.354|TWO_SIDED|95.0|0.6|1.61|||Log Rank|||||1.61|0.60|0.354
71839912|NCT02465268|143188420|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.354|TWO_SIDED|95.0|0.87|2.33|||Log Rank|||||2.33|0.87|0.354
71839913|NCT02465268|143188421|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
71839914|NCT02465268|143188421|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
71839915|NCT02465268|143188421|SUPERIORITY|||||||0.038|||||||Kruskal-Wallis|||||||0.038
71839916|NCT02465268|143188423|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71839917|NCT02465268|143188423|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71839918|NCT02465268|143188423|SUPERIORITY|||||||0.2|||||||Kruskal-Wallis|||||||0.2
71839919|NCT02465268|143188424|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
71839920|NCT02465268|143188424|SUPERIORITY|||||||0.6|||||||Kruskal-Wallis|||||||0.6
71839921|NCT02465268|143188424|OTHER|||||||0.6|||||||Kruskal-Wallis|||||||0.6
71839922|NCT02465268|143188426|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
71839923|NCT02465268|143188426|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
71839924|NCT02465268|143188426|SUPERIORITY|||||||0.13|||||||Kruskal-Wallis|||||||0.13
71839925|NCT06074172|143188444|OTHER|Linear Mixed Models were done with a compound symmetry covariance structure. This infers that the variances (pooled within-group) and covariances (across subjects) of all of the repeated measures are homogenous.||||||0.008||||||In the Bonferroni corrected Linear Mixed Model for PI Ratio, the p-value for the following interaction was reported: Treatment\*Age.|Linear Mixed Model|"Linear Mixed Model analyses:~1. Factor: Treatment group~2. Covariates: Age, Sex, CBD Use history, and Urine THC~3. Interactions"||||||0.008
71839926|NCT03020199|143188448|SUPERIORITY||Odds Ratio (OR)|16.8|||<|0.0001|TWO_SIDED|95.0|5.9|48.3|||Regression, Logistic||Logistic regression model with treatment as an explanatory variable and subset of significant covariates (including Baseline PASI score, age, BMI and their interaction terms with treatment) selected using forward selection method.|Week 52 PASI 90||48.3|5.9|<0.0001
71839927|NCT03020199|143188449|SUPERIORITY||Odds Ratio (OR)|0.8||||0.653|TWO_SIDED|95.0|0.3|2.1|||Regression, Logistic||Exact logistic regression method for Treatment group comparison, without using any covariates.|Week 104 PASI 90||2.1|0.3|0.6530
71839928|NCT04005794|143188458|OTHER|||||||0.004||||||Social latency t = 3.215|t-test, 2 sided|||||||0.004
71839929|NCT04005794|143188459|OTHER|||||||0.213|||||||ANOVA|||||||0.213
71839930|NCT04005794|143188460|OTHER|||||||0.01|||||||ANOVA|||||||0.01
71839931|NCT04005794|143188461|OTHER|||||||0.004|||||||ANOVA|||||||0.004
71839932|NCT04005794|143188462|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71839933|NCT05386030|143188529|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
71839934|NCT05386030|143188530|NON_INFERIORITY|The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB\> d0 where, pA is the response rate for saypha® VOLUME Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested based on Farrington-Manning-statistics with a one-sided type I error rate level of 0.025.|||||<|0.0001||||||Confirmatory testing will be performed in a hierarchical ordering: First analysis will be performed on the per protocol dataset, and if the corresponding p-value is below 0.025, the analysis will be performed on the full analysis dataset.|Farrington-Manning test|||||||<0.0001
71839935|NCT04719832|143188552|SUPERIORITY|Analysis performed using a negative binomial model with covariates of treatment, exacerbation history (2, 3, 4+), baseline inhaled CS dose (medium, high), geographical region, baseline percent predicted Forced Expiratory Volume in one second (FEV1), and offset of log (total time in the study in years).|Rate Ratio|0.42|||<|0.001|TWO_SIDED|95.0|0.3|0.59|||Negative binomial distribution|||To demonstrate the superiority of GSK3511294 100 mg SC + SoC following two doses (at Week 0 and at Week 26) compared with placebo + SoC, assessed by the annualized rate of clinically significant exacerbations measured over the study intervention period of 52 weeks.||0.59|0.30|< 0.001
71893056|NCT01658514|143307297|SUPERIORITY_OR_OTHER||% Ratio of LS Means|52.4||||0.0025|TWO_SIDED|90.0|37.61|73.02||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||73.02|37.61|0.0025
71673448|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.725|TWO_SIDED|||||The above p value corresponds to the Zygapophyseal Joint right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Zygapophyseal Joint right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.725
71839936|NCT04719832|143188553|SUPERIORITY||Difference in Least Square Means|-3.36|||=|0.08|TWO_SIDED|95.0|-7.11|0.39|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline SGRQ total score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline SGRQ total score and visit by treatment group||0.39|-7.11|= 0.080
71677319|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.998|||||TWO_SIDED|95.0|2.659|6.009||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.009|2.659|
71839937|NCT04719832|143188554|SUPERIORITY||Difference in Least Square Means|-0.04|||=|0.69|TWO_SIDED|95.0|-0.27|0.18|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ACQ-5 score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ACQ-5 score and visit by treatment group.||0.18|-0.27|= 0.690
71839938|NCT04719832|143188555|SUPERIORITY||Difference in Least Square Means|-0.001|||=|0.991|TWO_SIDED|95.0|-0.089|0.088|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline pre-bronchodilator FEV1, visit, visit by baseline pre-bronchodilator FEV1 and visit by treatment group.||0.088|-0.089|= 0.991
71839939|NCT04719832|143188556|SUPERIORITY||Difference in Least Square Means|-0.09|||=|0.65|TWO_SIDED|95.0|-0.5|0.31|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ANSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ANSD weekly mean score and visit by treatment group.||0.31|-0.50|= 0.650
71839940|NCT04719832|143188557|SUPERIORITY||Difference in Least Square Means|-0.08|||=|0.647|TWO_SIDED|95.0|-0.42|0.26|||Mixed Models Repeated Measures (MMRM)|||Analysis performed using a repeated measures model with covariates of treatment group, baseline ICS dose (medium or high), exacerbation history (2, 3, 4+), geographical region, baseline ADSD weekly mean score, baseline pre-bronchodilator percent predicted FEV1, visit, visit by baseline ADSD weekly mean score and visit by treatment group.||0.26|-0.42|= 0.647
71893057|NCT01658514|143307298|SUPERIORITY_OR_OTHER||% Ratio of LS Means|65.5||||0.0474|TWO_SIDED|90.0|46.32|92.68||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||92.68|46.32|0.0474
71839941|NCT05228457|143188559|SUPERIORITY|13 participants were randomized to receive active TMS, and 13 were randomized to receive sham TMS. 1 participant from each group withdrew, resulting in their exclusion from the analysis. Therefore, 24 participants were randomized to active (n = 12) or sham (n = 12) aiTBS groups. The analysis examined MADRS scores measured at baseline and post-treatment. A priori hypotheses were that active aiTBS would demonstrate measurable differences in MADRS scores compared to the sham group.|Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-19.94|-9.56|||t-test, 2 sided||The primary outcome was the between-group (Active vs Sham) difference in MADRS scores at the end of the treatment period. Results, including mean scores, standard deviations, confidence intervals, and p-value for the between-group comparisons.|||-9.56|-19.94|<0.001
71839942|NCT05228457|143188560|SUPERIORITY||Z-transformed Pearson's r values|-0.014||||0.04|TWO_SIDED||||||t-test, 2 sided|||Z-transformed Pearson's r values of average voxel-wise connectivity within the DMN||||0.04
71839943|NCT04324359|143188562|SUPERIORITY||||||<|0.001|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on the normal approximation test for differences between proportions.||||||<0.001
71839944|NCT04324359|143188563|SUPERIORITY|||||||0.066|||||||Other: z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.066
71839945|NCT04324359|143188564|SUPERIORITY|||||||0.716|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.716
71839946|NCT04324359|143188565|SUPERIORITY|||||||0.528|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level P-value: based on Barnard's exact test for differences between proportions.||||||0.528
71839947|NCT04324359|143188566|SUPERIORITY|||||||0.766|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.766
71795234|NCT03792672|143087448|SUPERIORITY||LSM difference|3.71|STANDARD_ERROR_OF_MEAN|4.16||0.379|TWO_SIDED|90.0|-3.32|10.7||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 100 ms peak-to-peak amplitude||10.7|-3.32|0.3790
71795235|NCT03792672|143087448|SUPERIORITY||LSM difference|7.36|STANDARD_ERROR_OF_MEAN|6.41||0.258|TWO_SIDED|90.0|-3.44|18.2||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||18.2|-3.44|0.2580
71893058|NCT01658514|143307298|SUPERIORITY_OR_OTHER||% Ratio of LS Means|77.3||||0.1691|TWO_SIDED|90.0|56.72|105.41||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||105.41|56.72|0.1691
71893059|NCT01658514|143307298|SUPERIORITY_OR_OTHER||% Ratio of LS Means|56.6||||0.0064|TWO_SIDED|90.0|40.73|78.63||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||78.63|40.73|0.0064
71893060|NCT01658514|143307298|SUPERIORITY_OR_OTHER||% Ratio of LS Means|54.6||||0.0097|TWO_SIDED|90.0|37.68|79.11||p-values \<0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment\*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.||79.11|37.68|0.0097
71795236|NCT03792672|143087448|SUPERIORITY||LSM difference|9.36|STANDARD_ERROR_OF_MEAN|6.41||0.1524|TWO_SIDED|90.0|-1.45|20.2|||Mixed Models Analysis|||LICI 200 ms peak-to-peak amplitude||20.2|-1.45|0.1524
71795237|NCT03792672|143087448|SUPERIORITY||LSM difference|17.2|STANDARD_ERROR_OF_MEAN|7.21||0.022|TWO_SIDED|90.0|5.06|29.4||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||29.4|5.06|0.0220
71893061|NCT01658514|143307299|SUPERIORITY_OR_OTHER|||||||0.9444|TWO_SIDED|||||R² for Placebo-adjusted Change from Pre-dose Value in Lactate Versus Metformin Concentration|Pearson Correlation|||||||0.9444
71839948|NCT04324359|143188567|SUPERIORITY|||||||0.619|||||||z-test for proportions|Other: z-test for proportions, 2-sided test at alpha = 5% level. P-value: based on Barnard's exact test for differences between proportions.||||||0.619
71839949|NCT04898673|143188579|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-6.08|-4.37|||ANOVA|||||-4.37|-6.08|<0.001
71795238|NCT03792672|143087448|SUPERIORITY||LSM difference|9.58|STANDARD_ERROR_OF_MEAN|7.23||0.1927|TWO_SIDED|90.0|-2.59|21.8||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||LICI 300 ms peak-to-peak amplitude||21.8|-2.59|0.1927
71795239|NCT03792672|143087449|SUPERIORITY||LSM difference|-5.65|STANDARD_ERROR_OF_MEAN|9.59||0.559|TWO_SIDED|90.0|-21.8|10.5||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||10.5|-21.8|0.5590
71795240|NCT03792672|143087449|SUPERIORITY||LSM difference|-16.1|STANDARD_ERROR_OF_MEAN|9.72||0.1049|TWO_SIDED|90.0|-32.5|0.242|||Mixed Models Analysis|||SICI 2 ms peak-to-peak amplitude||0.242|-32.5|0.1049
71795241|NCT03792672|143087449|SUPERIORITY||LSM difference|-16.7|STANDARD_ERROR_OF_MEAN|13.5||0.2238|TWO_SIDED|90.0|-39.4|6.06||Based on mixed model analysis, with treatment, period, sequence, treatment-by-period interaction as fixed factors, participant within sequence as a random factor, baseline as a covariate.|Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||6.06|-39.4|0.2238
71795242|NCT03792672|143087449|SUPERIORITY||LSM difference|-18.3|STANDARD_ERROR_OF_MEAN|13.6||0.1847|TWO_SIDED|90.0|-41.3|4.56|||Mixed Models Analysis|||SICI 5 ms peak-to-peak amplitude||4.56|-41.3|0.1847
71839950|NCT04898673|143188580|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.39||0.67|TWO_SIDED|95.0|-2.31|3.51|||ANOVA|||||3.51|-2.31|0.670
71839951|NCT04898673|143188581|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-3.75|STANDARD_ERROR_OF_MEAN|1.55||0.026|TWO_SIDED|95.0|-7.0|-0.5|||ANOVA|||||-0.50|-7.00|0.026
71795243|NCT03519971|143087488|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.247|TWO_SIDED|95.0|0.647|1.123|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||The hazard ratio (HR) and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for age \[\< 65 versus (vs.) \>= 65 years\] and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.||1.123|0.647|0.247
71795244|NCT03519971|143087489|SUPERIORITY||Difference in percentages|0.2||||0.976|TWO_SIDED|99.5|-15.2|16.3|||Cochran-Mantel-Haenszel|The analysis was performed using a Cochran-Mantel-Haenszel (CMH) test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|The CIs for difference in percentages were estimated using Miettinen and Nurminen's method.|||16.3|-15.2|0.976
71839952|NCT04898673|143188582|NON_INFERIORITY|Non-inferiority margin=-10% words correct; CP1110 non-inferior to CP1000 if the lower limit of the confidence interval for the difference \> -10% words correct.|Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|1.37||0.411|TWO_SIDED|95.0|-4.02|1.72|||ANOVA|||||1.72|-4.02|0.411
71839953|NCT03899259|143188589|SUPERIORITY||Odds Ratio (OR)|7.86|||<|0.001|TWO_SIDED|95.0|2.79|22.17|||Regression, Logistic|||||22.17|2.79|<0.001
71839954|NCT03899259|143188589|SUPERIORITY||Odds Ratio (OR)|19.72|||<|0.001|TWO_SIDED|95.0|7.3|53.3|||Regression, Logistic|||||53.30|7.30|<0.001
71839955|NCT03899259|143188590|SUPERIORITY||Mean Difference (Final Values)|-25.25|STANDARD_ERROR_OF_MEAN|3.834|<|0.001|TWO_SIDED|95.0|-32.78|-17.72|||ANCOVA|||||-17.72|-32.78|<0.001
71839956|NCT03899259|143188590|SUPERIORITY||Mean Difference (Final Values)|-44.49|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-51.33|-37.65|||ANCOVA|||||-37.65|-51.33|<0.001
71839957|NCT03899259|143188591|SUPERIORITY||Odds Ratio (OR)|4.63||||0.005|TWO_SIDED|95.0|1.58|13.6|||Regression, Logistic|||||13.60|1.58|0.005
71839958|NCT03899259|143188591|SUPERIORITY||Odds Ratio (OR)|12.94|||<|0.001|TWO_SIDED|95.0|4.72|35.44|||Regression, Logistic|||||35.44|4.72|<0.001
71839959|NCT03899259|143188592|SUPERIORITY||Odds Ratio (OR)|4.36||||0.001|TWO_SIDED|95.0|1.77|10.74|||Regression, Logistic|||||10.74|1.77|0.001
71839960|NCT03899259|143188592|SUPERIORITY||Odds Ratio (OR)|13.37|||<|0.001|TWO_SIDED|95.0|5.75|31.1|||Regression, Logistic|||||31.10|5.75|<0.001
71839961|NCT03899259|143188594|SUPERIORITY||Odds Ratio (OR)|2.56||||0.076|TWO_SIDED|95.0|0.91|7.24|||Regression, Logistic|||||7.24|0.91|0.076
71839962|NCT03899259|143188594|SUPERIORITY||Odds Ratio (OR)|10.3|||<|0.001|TWO_SIDED|95.0|4.12|25.77|||Regression, Logistic|||||25.77|4.12|<0.001
71839963|NCT03899259|143188595|SUPERIORITY||Odds Ratio (OR)|1.88||||0.26|TWO_SIDED|95.0|0.63|5.62|||Regression, Logistic|||||5.62|0.63|0.260
71839964|NCT03899259|143188595|SUPERIORITY||Odds Ratio (OR)|8.1|||<|0.001|TWO_SIDED|95.0|3.18|20.66|||Regression, Logistic|||||20.66|3.18|<0.001
71839965|NCT03899259|143188596|SUPERIORITY||Odds Ratio (OR)|3.43||||0.017|TWO_SIDED|95.0|1.25|9.4|||Regression, Logistic|||||9.40|1.25|0.017
71839966|NCT03899259|143188596|SUPERIORITY||Odds Ratio (OR)|10.85|||<|0.001|TWO_SIDED|95.0|4.32|27.25|||Regression, Logistic|||||27.25|4.32|<0.001
71839967|NCT03899259|143188597|SUPERIORITY||Odds Ratio (OR)|14.63||||0.002|TWO_SIDED|95.0|2.73|78.42|||Regression, Logistic|||||78.42|2.73|0.002
71839968|NCT03899259|143188597|SUPERIORITY||Odds Ratio (OR)|30.37|||<|0.001|TWO_SIDED|95.0|5.93|99.99|||Regression, Logistic|||||99.99|5.93|<0.001
71839969|NCT03899259|143188598|SUPERIORITY||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|1.981||0.129|TWO_SIDED|95.0|-6.91|0.88|||ANCOVA|||||0.88|-6.91|0.129
71839970|NCT03899259|143188598|SUPERIORITY||Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|1.799||0.02|TWO_SIDED|95.0|-7.75|-0.68|||ANCOVA|||||-0.68|-7.75|0.020
71839971|NCT03899259|143188599|SUPERIORITY||Mean Difference (Final Values)|-6.75|STANDARD_ERROR_OF_MEAN|3.017||0.026|TWO_SIDED|95.0|-12.68|-0.82|||ANCOVA|||||-0.82|-12.68|0.026
71839972|NCT03899259|143188599|SUPERIORITY||Mean Difference (Final Values)|-13.42|STANDARD_ERROR_OF_MEAN|2.737|<|0.001|TWO_SIDED|95.0|-18.8|-8.04|||ANCOVA|||||-8.04|-18.80|<0.001
71839973|NCT03899259|143188600|SUPERIORITY||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|2.68||0.103|TWO_SIDED|95.0|-9.65|0.88|||ANCOVA|||||0.88|-9.65|0.103
71673449|NCT05870371|142865056|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.398|TWO_SIDED|||||The above p value corresponds to the Upper Trapezius Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.398
71673450|NCT05870371|142865056|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.03|=|0.186|TWO_SIDED|||||The above p value corresponds to the Mastoid Process right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Upper Trapezius Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.186
71795245|NCT03519971|143087490|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|1.03||||0.823|TWO_SIDED|95.0|0.778|1.386|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.386|0.778|0.823
71795246|NCT03519971|143087491|SUPERIORITY|For the comparison between treatments, the Kaplan-Meier estimator of survival at 24 months for each treatment was used to obtain the HR and the test is based on the method described in Klein 2007. To account for the stratification factors, the estimates and test statistics in each strata were combined by weighting inversely proportionately according to each within stratum variance.|Hazard Ratio (HR)|1.04||||0.847|TWO_SIDED|95.0|0.716|1.502|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.502|0.716|0.847
71795247|NCT03519971|143087492|SUPERIORITY|The analysis was performed using a CMH test, stratified by age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).|Difference in percentages|0.0|||||TWO_SIDED|95.0|-4.8|3.0|||||The CIs for difference in percentages was calculated using Miettinen and Nurminen's method.|||3.0|-4.8|
71795248|NCT03519971|143087495|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.95||||0.79|TWO_SIDED|95.0|0.649|1.413|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.413|0.649|0.790
71795249|NCT03519971|143087496|SUPERIORITY|The HR and CIs were calculated using a stratified Cox proportional hazards model, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C), with treatment as the only covariate and ties handled by Efron approach.|Hazard Ratio (HR)|0.81||||0.132|TWO_SIDED|95.0|0.614|1.071|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for age (\< 65 vs. \>= 65 years) and stage (IIIA vs. IIIB/C).||||1.071|0.614|0.132
71795250|NCT04007523|143087518|OTHER|Fisher's Exact Test||||||0.653|||||||Fisher Exact|||||||0.653
71795251|NCT04007523|143087518|OTHER|Fisher's Exact Test||||||0.614|||||||Fisher Exact|||||||0.614
71795252|NCT04007523|143087518|OTHER|Fisher's Exact Test||||||0.999|||||||Fisher Exact|||||||0.999
71795253|NCT04652479|143087544|OTHER|||||||0.0028||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0028
71795254|NCT04652479|143087544|OTHER|||||||0.0005||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0005
71795255|NCT04652479|143087545|OTHER|||||||0.0027||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0027
71795256|NCT04652479|143087545|OTHER|||||||0.0043||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0043
71795257|NCT04652479|143087546|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
71795258|NCT04652479|143087546|OTHER|||||||0.0003||||||A p-value of \<0.05 would be considered statistically significant|Mixed effects model|||Within-group analysis||||0.0003
71795259|NCT04652479|143087547|OTHER|||||||0.161||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.161
71795260|NCT04652479|143087547|OTHER||Mean Difference (Net)|-35.66||||0.201|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.201
71795261|NCT04652479|143087547|OTHER||Mean Difference (Net)|-67.65||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Within-group analysis of change from baseline||||0.001
71795262|NCT04652479|143087548|OTHER|||||||0.145||||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided|||Between-group analysis of change from baseline||||0.145
71795263|NCT04652479|143087548|OTHER||Mean Difference (Net)|-31.88||||0.111|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.111
71795264|NCT04652479|143087548|OTHER||Mean Difference (Net)|-53.37||||0.001|TWO_SIDED|||||A p-value of \<0.05 would be considered statistically significant|t-test, 2 sided||Change in percentage|Within-group analysis of change from baseline||||0.001
71839974|NCT03899259|143188600|SUPERIORITY||Mean Difference (Final Values)|-8.33|STANDARD_ERROR_OF_MEAN|2.429|<|0.001|TWO_SIDED|95.0|-13.1|-3.56|||ANCOVA|||||-3.56|-13.10|<0.001
71839975|NCT03899259|143188601|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.315||0.518|TWO_SIDED|95.0|-0.82|0.42|||ANCOVA|||||0.42|-0.82|0.518
71839976|NCT03899259|143188601|SUPERIORITY||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.286||0.012|TWO_SIDED|95.0|-1.28|-0.16|||ANCOVA|||||-0.16|-1.28|0.012
71839977|NCT03899259|143188602|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.291||0.083|TWO_SIDED|95.0|-1.08|0.07|||ANCOVA|||||0.07|-1.08|0.083
71839978|NCT03899259|143188602|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.264||0.01|TWO_SIDED|95.0|-1.2|-0.16|||ANCOVA|||||-0.16|-1.20|0.010
71839979|NCT01152450|143188608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.102|0.196|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.196|0.102|<0.0001
71795265|NCT05045144|143087616|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.92|1.13|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 2 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.13|0.92|
71795266|NCT05045144|143087616|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 1 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.05|0.85|
71795267|NCT05045144|143087616|OTHER|The lot-to-lot consistency is demonstrated only if two-sided 95% confidence intervals (CI) for the 3 pair-wise geometric mean ratios of RSV MAT IgG ELISA concentration falls within 0.67 and 1.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.83|1.03|||GMC ratio|||To demonstrate lot-to-lot consistency of the immune responses of Lot 2 and Lot 3 of the RSV MAT vaccine, as measured by ELISA in terms of IgG GMCs at Day 31.||1.03|0.83|
71795268|NCT05045144|143087617|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for the A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.72|||||TWO_SIDED|95.0|0.63|0.82|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||0.82|0.63|
71795269|NCT05045144|143087617|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Washington/02/2019 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.79|1.1|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||1.10|0.79|
71795270|NCT05045144|143087617|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated for B/Phuket/3073/2013 strain, if the lower limit (LL) of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by Flu D-QIV vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93|||GMC ratio|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the ratio of HI GMTs of Flu D-QIV antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||0.93|0.69|
71839980|NCT01152450|143188608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.111|0.205|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.205|0.111|<0.0001
71839981|NCT01152450|143188608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.038|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.056|-0.038|
71839982|NCT01152450|143188609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.328|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001||95.0|11.084|31.573|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||31.573|11.084|<0.0001
71839983|NCT01152450|143188609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|5.225|<|0.0001||95.0|12.044|32.67|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||32.670|12.044|<0.0001
71839984|NCT01152450|143188609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.029|STANDARD_ERROR_OF_MEAN|5.242||||95.0|-9.318|11.376|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||11.376|-9.318|
71839985|NCT01152450|143188610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.92|STANDARD_ERROR_OF_MEAN|5.026|<|0.0001||95.0|20.001|39.839|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||39.839|20.001|<0.0001
71839986|NCT01152450|143188610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|28.657|STANDARD_ERROR_OF_MEAN|5.042|<|0.0001||95.0|18.707|38.606|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||38.606|18.707|<0.0001
71839987|NCT01152450|143188610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.264|STANDARD_ERROR_OF_MEAN|5.056||||95.0|-11.243|8.716|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||8.716|-11.243|
71839988|NCT01152450|143188611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.12|0.218|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.218|0.120|<0.0001
71839989|NCT01152450|143188611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001||95.0|0.136|0.234|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.234|0.136|<0.0001
71893062|NCT01658514|143307299|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||R² for placebo-adjusted change from pre-dose value in lactate versus metformin concentration|Pearson Correlation|||||||<0.0001
71673451|NCT05870371|142865056|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.833|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.833
71673452|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.469|TWO_SIDED|||||The above p value corresponds to the Levator Scapulae Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Levator Scapulae Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.469
71795271|NCT05045144|143087618|NON_INFERIORITY|The non-inferiority of RSV MAT vaccine is demonstrated for RSV A neutralizing antibody titers, if the LL of the 95% CI on the GMT ratio (RSV MAT + Flu D-QIV vaccine divided by RSV MAT vaccine) is greater than 0.67 at Day 31 post vaccination.|GMC ratio|0.87|||||TWO_SIDED|95.0|0.78|0.97|||GMC ratio|||To demonstrate the immunological non-inferiority of the RSV MAT vaccine when co-administered with Flu D-QIV vaccine, compared to RSV MAT vaccine given alone as measured by the ratio of GMTs of RSV A neutralizing antibody titers at 30 days post administration (Day 31).||0.97|0.78|
71795272|NCT05045144|143087619|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|3.44|||||TWO_SIDED|95.0|-3.44|10.29|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against A/Tasmania/503/2020 (H3N2) IVR-221 strain at 30 days post administration (Day 31).||10.29|-3.44|
71795273|NCT05045144|143087619|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Washington/02/2019 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.15|||||TWO_SIDED|95.0|-2.04|10.32|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Washington/02/2019 strain at 30 days post administration (Day 31).||10.32|-2.04|
71795274|NCT05045144|143087619|NON_INFERIORITY|The non-inferiority of Flu D-QIV vaccine is demonstrated with respect to the SCR difference for Flu D-QIV antibody titers against B/Phuket/3073/2013 strain, if the upper limit (UL) of the 95% CI on the SCR difference (Flu D-QIV vaccine minus RSV MAT + Flu D-QIV vaccine) is less than or equal to the pre-defined clinical limit of 10% at Day 31 post vaccination.|Difference of Proportion|4.08|||||TWO_SIDED|95.0|-2.46|10.58|||Miettinen and Nurminen|||To demonstrate the immunological non-inferiority of the Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone as measured by the difference of proportion of participants achieving seroconversion for HI antibody titers against B/Phuket/3073/2013 strain at 30 days post administration (Day 31).||10.58|-2.46|
71795275|NCT02486042|143087627|OTHER|T-test for equality in means. The p-value threshold for significance was p \< 0.05.||||||0.22|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T0 blood samples in the Standard of Care versus Omegaven group||||0.22
71795276|NCT02486042|143087627|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.15|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T0 blood samples in the Standard of Care versus Omegaven group||||0.15
71795277|NCT02486042|143087627|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.78|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T0 blood samples in the Standard of Care versus Omegaven group||||0.78
71893063|NCT00004980|143307313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.76|STANDARD_ERROR_OF_MEAN|0.514||0.005||95.0|-4.65|-0.86||a priori threshold for statistical significance was .05|t-test, 2 sided|degree of freedom = 48||||-.86|-4.65|.005
71893064|NCT00004980|143307314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.327||0.002||95.0|0.507|2.03||a priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 48||null hypothesis is that the groups are the same||2.03|.507|.002
71795278|NCT02486042|143087631|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.43|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T1 blood samples in the Standard of Care versus Omegaven group||||0.43
71795279|NCT02486042|143087631|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.44|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T1 blood samples in the Standard of Care versus Omegaven group||||0.44
71893065|NCT00004980|143307315|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.949|STANDARD_ERROR_OF_MEAN|0.524||0.001||95.0|-1.45|-0.44||A priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 46||||-.44|-1.45|.001
71673453|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.399|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.399
71758456|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.33|-0.87|<0.0001
71758457|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.58|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.41|-0.75|<0.0001
71758458|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.34||||0.0051|TWO_SIDED|95.0|-0.58|-0.1|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.10|-0.58|0.0051
71758459|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-1.08|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.83|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.83|-1.33|<0.0001
71758460|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-0.05||||0.6541|TWO_SIDED|95.0|-0.26|0.16|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||0.16|-0.26|0.6541
71758461|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.76|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.76|-1.28|<0.0001
71758462|NCT02420821|143019168|SUPERIORITY||LS Mean Difference|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.88|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.||-0.88|-1.27|<0.0001
71758463|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.73|||<|0.0001|TWO_SIDED|95.0|0.58|0.87|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.87|0.58|<0.0001
71758464|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.42|||<|0.0001|TWO_SIDED|95.0|0.28|0.57|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.57|0.28|<0.0001
71758465|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.84|0.55|<0.0001
71758466|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.44|<0.0001
71839990|NCT01152450|143188611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.025||||95.0|-0.033|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.065|-0.033|
71839991|NCT01152450|143188612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.077|0.181|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.181|0.077|<0.0001
71839992|NCT01152450|143188612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.079|0.183|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.183|0.079|<0.0001
71839993|NCT01152450|143188612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.05|0.054|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.054|-0.050|
71795280|NCT02486042|143087631|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.5|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T1 blood samples in the Standard of Care versus Omegaven group||||0.50
71795281|NCT02486042|143087632|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STAT-3 in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
71839994|NCT01152450|143188613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.179|0.084|<0.0001
71839995|NCT01152450|143188613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.179|0.084|<0.0001
71839996|NCT01152450|143188613|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.024||||95.0|-0.048|0.047|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.047|-0.048|
71839997|NCT01152450|143188614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.17|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.170|0.053|0.0002
71839998|NCT01152450|143188614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.074|0.191|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.191|0.074|<0.0001
71839999|NCT01152450|143188614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.03||||95.0|-0.037|0.08|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.080|-0.037|
71840000|NCT01152450|143188615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.035||0.0515||95.0|0.0|0.136|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.136|0.000|0.0515
71840001|NCT01152450|143188615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.035||0.1058||95.0|-0.012|0.124|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.124|-0.012|0.1058
71840002|NCT01152450|143188615|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.035||||95.0|-0.08|0.057|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.057|-0.080|
71893066|NCT00004980|143307316|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||a priori threshold for statistical significance = .05|Chi-squared|||||||.01
71795282|NCT02486042|143087632|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.001|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of PPAR-gamma in T2 blood samples in the Standard of Care versus Omegaven group||||0.001
71840003|NCT01152450|143188616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.073|0.177|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.177|0.073|<0.0001
71840004|NCT01152450|143188616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.026||0.0002||95.0|0.048|0.152|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.152|0.048|0.0002
71840005|NCT01152450|143188616|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||95.0|-0.077|0.027|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.027|-0.077|
71840006|NCT01152450|143188617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.027||0.0051||95.0|0.023|0.129|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.129|0.023|0.0051
71840007|NCT01152450|143188617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.027||0.0123||95.0|0.015|0.12|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.120|0.015|0.0123
71840008|NCT01152450|143188617|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.061|0.045|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.045|-0.061|
71840009|NCT01152450|143188618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.027||0.0042||95.0|0.025|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.130|0.025|0.0042
71840010|NCT01152450|143188618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.027||0.0747||95.0|-0.005|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.005|0.0747
71840011|NCT01152450|143188618|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.027||||95.0|-0.082|0.023|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.023|-0.082|
71893067|NCT00702143|143307317|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0002
71795283|NCT02486042|143087632|OTHER|T-test for equality of means. The p-value threshold for significance was p \< 0.05.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: there was no difference in the average dCt values for relative gene expression of STC-1 in T2 blood samples in the Standard of Care versus Omegaven group||||0.01
71795284|NCT01466387|143087634|NON_INFERIORITY_OR_EQUIVALENCE|GMC TF+YF+MenACWY-CRM/GMC TF+YF.|Ratio of GMC|1.14|||||TWO_SIDED|95.0|0.81|1.6||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.6|0.81|
71795285|NCT01466387|143087635|NON_INFERIORITY_OR_EQUIVALENCE|GMT TF+YF+MenACWY/GMT TF+YF.|Ratio of GMT.|0.96|||||TWO_SIDED|95.0|0.65|1.41||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.||1.41|0.65|
71795286|NCT01466387|143087636|NON_INFERIORITY_OR_EQUIVALENCE|GMT JE + Rab + MenACWY-CRM/GMT JE + Rab.|Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.7|1.16||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and centers as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.16|0.7|
71795287|NCT01466387|143087637|NON_INFERIORITY_OR_EQUIVALENCE|GMC JE + Rab + MenACWY-CRM/GMC JE + Rab.|Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.71|1.17||The testing was done by assessing the confidence interval of the ratio.|ANCOVA|The ANCOVA model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.||1.17|0.71|
71795288|NCT00896337|143087661|SUPERIORITY_OR_OTHER||9-month major adverse event rate|3.4|||<|0.0001|TWO_SIDED|95.0|0.9|8.5||A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.|One-sided exact-test|||MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of \<=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.||8.5|0.9|<0.0001
71795289|NCT01586819|143087725|SUPERIORITY||Z score|-3.3902||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.||||.002
71795290|NCT01586819|143087726|SUPERIORITY||Z score|3.6115||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.||||.001
71840012|NCT01152450|143188622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.055|0.147|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.147|0.055|<0.0001
71840013|NCT01152450|143188622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.023||0.0004||95.0|0.038|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.130|0.038|0.0004
71795291|NCT01883427|143087736|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Not significant|Wilcoxon (Mann-Whitney)|||Too few included to reach power||||>0.05
71795292|NCT01796197|143087781|SUPERIORITY||Pathelogic Complete Response Rate|40.0|||||TWO_SIDED||||||Two stage design, exact method||Decision Rule: If the percentage of participants experiencing pathologic complete response (pCR) is ≤ 15% then the preoperative regimen is considered minimally effective. If the proportion of pCR ≥ 40% then the regimen is worthy of further study.|Null Hypothesis: pCR rate is less than or equal to 15% Alternative Hypothesis: pCR rate is greater than or equal to 40% Hypothesized False Positive Rate (alpha) : 3.9% Hypothesized False Negative Rate (1-beta) : 9.9%||||
71795293|NCT01713868|143087836|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.||||||0.03||||||Adjusted education effect p=0.34. Adjusted mHealth effect p\<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||0.03
71840014|NCT01152450|143188622|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.023||||95.0|-0.063|0.03|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.030|-0.063|
71673454|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.02|=|0.752|TWO_SIDED|||||The above p value corresponds to the Deltoid Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Deltoid Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.752
71673455|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.002|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle left algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle left algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.002
71673456|NCT05870371|142865056|OTHER||Dependence coefficient (β)|-0.07|STANDARD_ERROR_OF_MEAN|0.02|=|0.003|TWO_SIDED|||||The above p value corresponds to the Tibialis Anterior Muscle right algometric site. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Tibialis Anterior Muscle right algometric site. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of applying ATM does not differ in reducing the pain sensitivity assessed by the Pain Pressure Threshold (PPT) measured with the pressure algometer (Commander Algometer) in patients with chronic neck pain from applying A-S (main hypothesis).||||=0.003
71673457|NCT05870371|142865057|OTHER||Mean Difference (Net)|5.41|||=|0.002|TWO_SIDED|||||The above p value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.002
71673458|NCT05870371|142865057|OTHER||Mean Difference (Net)|4.92|||=|0.046|TWO_SIDED|||||The above p value corresponds to the Rotation average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rotation average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.046
71673459|NCT05870371|142865057|OTHER||Mean Difference (Net)|3.81|||<|0.001|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.001
71813333|NCT01181726|143129090|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.96|||||TWO_SIDED|90.0|93.66|102.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.46|93.66|
71673460|NCT05870371|142865057|OTHER||Mean Difference (Net)|3.57|||=|0.043|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Lateral Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.043
71673461|NCT05870371|142865057|OTHER||Mean Difference (Net)|4.52|||=|0.018|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.018
71673462|NCT05870371|142865057|OTHER||Mean Difference (Net)|4.45|||=|0.102|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Flexion average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.102
71673463|NCT05870371|142865057|OTHER||Mean Difference (Net)|5.85|||=|0.16|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension maximum.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||=0.160
71795294|NCT01713868|143087837|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect: p=0.22. Adjusted mHealth effect p\<0.001. Test for interaction p=0.08.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.||||<0.001
71795295|NCT01713868|143087838|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.07. Adjusted mHealth effect p\<0.001. Test for interaction p=0.54|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
71795296|NCT01713868|143087839|SUPERIORITY|GEE logistic regression accounted for within-hospital clustering, individual-level \& hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.33. Adjusted mHealth effect p\<0.001. Test for interaction p=0.29.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p\<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.||||<0.001
71795297|NCT01713868|143087840|OTHER|Causal mediation analysis|Difference in proportions|0.16|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
71795298|NCT01713868|143087841|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
71795299|NCT01713868|143087842|OTHER|Causal mediation analysis|Difference in proportions|0.14|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
71840015|NCT01152450|143188623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.242|STANDARD_ERROR_OF_MEAN|4.091|<|0.0001||95.0|22.167|38.317|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||38.317|22.167|<0.0001
71840016|NCT01152450|143188623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.31|STANDARD_ERROR_OF_MEAN|4.089|<|0.0001||95.0|26.24|42.38|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||42.380|26.240|<0.0001
71795300|NCT01713868|143087843|OTHER|Causal mediation analysis|Difference in proportions|0.15|||||TWO_SIDED|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.|||
71795301|NCT05620576|143087844|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.61|0.82|||||Posterior mean difference with 95% credible interval is reported.|||0.82|-0.61|
71795302|NCT05620576|143087845|SUPERIORITY||Posterior Mean Difference|0.26|||||TWO_SIDED|95.0|-0.47|0.99|||||Posterior mean difference with 95% credible interval is reported.|||0.99|-0.47|
71795303|NCT05620576|143087846|SUPERIORITY||Posterior Mean Difference|0.33|||||TWO_SIDED|95.0|-0.11|0.78|||||Posterior mean difference with 95% credible interval is reported.|||0.78|-0.11|
71795304|NCT05620576|143087847|SUPERIORITY||Posterior Mean Difference|0.2|||||TWO_SIDED|95.0|-0.56|0.96|||||Posterior mean difference with 95% credible interval is reported.|||0.96|-0.56|
71840017|NCT01152450|143188623|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.068|STANDARD_ERROR_OF_MEAN|4.094||||95.0|-4.012|12.148|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||12.148|-4.012|
71795305|NCT05620576|143087848|SUPERIORITY||Posterior Mean Difference|-0.77|||||TWO_SIDED|95.0|-9.41|7.75|||||Posterior mean difference with 95% credible interval is reported.|||7.75|-9.41|
71795306|NCT05620576|143087849|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.51|0.24|||||Posterior mean difference with 95% credible interval is reported.|||0.24|-0.51|
71795307|NCT05620576|143087850|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
71795308|NCT05620576|143087851|SUPERIORITY||Posterior Mean Difference|23.02|||||TWO_SIDED|95.0|-108.05|152.33|||||Posterior mean difference with 95% credible interval is reported.|||152.33|-108.05|
71795309|NCT05394025|143087854|SUPERIORITY||Interaction|0.02||||0.77|TWO_SIDED|95.0|-0.13|0.18|||likelihood ratio test||Beta for time by COVID-19 status|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.18|-0.13|0.77
71795310|NCT05394025|143087854|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6|TWO_SIDED|95.0|-0.44|0.67|||likelihood ratio test||Beta coefficient for mean difference in mean longitudinal I/ADL score|Null hypothesis no difference in trends of I/ADL scores between Veterans with COVID-19 and comparators. We used adjusted linear mixed model (LMM) to model I/ADL scores over time (i.e., survey cycles) and by COVID-19 status. The LMM included an interaction term for time and COVID-19 status. LMM models were fitted with random intercepts (i.e., patient ID) and slopes (i.e., survey cycle). LMMs included fixed effects for patient baseline age, sex, and care assessment needs score.||0.67|-0.44|0.60
71795311|NCT04214288|143087857|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0167||90.0|0.42|0.82|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.82|0.42|0.0167
71795312|NCT04214288|143087857|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.009||90.0|0.46|0.89|||Log Rank|The analysis was performed using a stratified Cox Proportional Hazards model.|A hazard ratio \< 1 favours AZD9833 to be associated with a longer progression-free survival than fulvestrant.|||0.89|0.46|0.0090
71795313|NCT04214288|143087858|SUPERIORITY||Odds Ratio (OR)|1.42||||0.4828||90.0|0.63|3.31|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.31|0.63|0.4828
71795314|NCT04214288|143087858|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3691||90.0|0.69|3.67|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||3.67|0.69|0.3691
71795315|NCT04214288|143087862|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2554|TWO_SIDED|90.0|0.84|2.64|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.64|0.84|0.2554
71795316|NCT04214288|143087862|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1658||90.0|0.91|2.89|||Regression, Logistic|The analysis was performed using logistic regression model adjusting for prior use of CDK4/6 inhibitors and presence of lung and/or liver metastasis.|An odds ratio \> 1 favours AZD9833.|||2.89|0.91|0.1658
71795317|NCT02121483|143087869|SUPERIORITY_OR_OTHER||Slope|0.949|STANDARD_ERROR_OF_MEAN|0.1075|||TWO_SIDED|95.0|0.7276|1.1704|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% confidence interval (CI) for the slope was computed.|||1.1704|0.7276|
71795318|NCT02121483|143087870|SUPERIORITY_OR_OTHER||Slope|0.9597|STANDARD_ERROR_OF_MEAN|0.1088|||TWO_SIDED|95.0|0.7356|1.1838|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1838|0.7356|
71795319|NCT02121483|143087871|SUPERIORITY_OR_OTHER||Slope|0.8554|STANDARD_ERROR_OF_MEAN|0.1481|||TWO_SIDED|95.0|0.5504|1.1603|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.|||1.1603|0.5504|
71795320|NCT01420289|143087877|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_ERROR_OF_MEAN|15.0||0.086|TWO_SIDED|95.0|10.0|80.0|||t-test, 2 sided|||||80|10|0.086
71795321|NCT01420289|143087878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|11.0|<|0.05|TWO_SIDED|95.0|10.0|100.0|||t-test, 2 sided|||||100|10|<0.05
71795322|NCT01203072|143087881|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified|Cochran-Armitage|||As the primary analysis, the dose-response relationship in the incidence of thromboembolic event was verified using the Cochran-Armitage test.||||<0.001
71795323|NCT03387813|143087913|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1624|TWO_SIDED|95.0|0.74|1.05|||Anderson-Gill model (robust sandwich)|||||1.05|0.74|0.1624
71795324|NCT03387813|143087917|EQUIVALENCE|Clinical equivalence was met if the lower limit of the confidence interval (CI) of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|90.0|0.44|0.6||||||||0.60|0.44|
71795325|NCT03387813|143087921|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0958|TWO_SIDED|95.0|0.7|1.03|||Anderson-Gill model (robust sandwich)|||||1.03|0.70|0.0958
71795326|NCT03387813|143087925|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0644|TWO_SIDED|95.0|0.68|1.01|||Anderson-Gill model (robust sandwich)|||||1.01|0.68|0.0644
71795327|NCT03387813|143087929|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8867|TWO_SIDED|95.0|0.61|1.77|||Anderson-Gill model (robust sandwich)|||||1.77|0.61|0.8867
71795328|NCT03387813|143087933|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7119|TWO_SIDED|95.0|0.7|1.7|||Anderson-Gill model (robust sandwich)|||||1.70|0.70|0.7119
71795329|NCT03387813|143087937|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.44||0.3484|TWO_SIDED|95.0|-4.16|1.47|||t-test, 1 sided|||||1.47|-4.16|0.3484
71795330|NCT03387813|143087937|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|1.47||0.6684|TWO_SIDED|95.0|-3.51|2.26|||t-test, 1 sided|||||2.26|-3.51|0.6684
71795331|NCT03387813|143087939|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.37||0.9901|TWO_SIDED|95.0|-2.68|2.71|||t-test, 1 sided|||||2.71|-2.68|0.9901
71795332|NCT03387813|143087939|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|1.41||0.2947|TWO_SIDED|95.0|-1.29|4.24|||t-test, 1 sided|||||4.24|-1.29|0.2947
71795333|NCT03387813|143087941|SUPERIORITY||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|7.36||0.5741|TWO_SIDED|95.0|-10.32|18.6|||t-test, 1 sided|||||18.60|-10.32|0.5741
71795334|NCT03387813|143087941|SUPERIORITY||Mean Difference (Final Values)|2.93|STANDARD_ERROR_OF_MEAN|7.81||0.7077|TWO_SIDED|95.0|-12.41|18.27|||t-test, 1 sided|||||18.27|-12.41|0.7077
71795335|NCT03387813|143087944|EQUIVALENCE|Clinical equivalence was met if the lower limit of the CI of ln(HR) for the primary endpoint in Elevated NT-proBNP/BNP only vs. prior HFH only subjects is \> -0.2877 and the upper limit is \< 0.2877.|Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.38|0.55||||||||0.55|0.38|
71795336|NCT03387813|143087948|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71795337|NCT03387813|143087952|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71795338|NCT03387813|143087956|OTHER|||||||0.0001|||||||ANOVA|||||||0.0001
71795339|NCT03387813|143087962|OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.39|0.54|||Anderson-Gill model (robust sandwich)|||||0.54|0.39|<0.0001
71795340|NCT03387813|143087963|OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.53|0.76|||Anderson-Gill model (robust sandwich)|||||0.76|0.53|<0.001
71795341|NCT03387813|143087968|SUPERIORITY||Least Square Means Difference (T vs C)|1.53|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|0.29|2.78|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 6 months between Treatment vs Control group||2.78|0.29|0.0160
71795342|NCT03387813|143087968|SUPERIORITY||Least Square Means Difference (T vs C)|0.79|STANDARD_ERROR_OF_MEAN|0.39||0.0427|TWO_SIDED|95.0|0.03|1.56|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 6 months between Treatment vs Control group.||1.56|0.03|0.0427
71795343|NCT03387813|143087968|SUPERIORITY||Least Square Means Difference (T vs C)|1.13|STANDARD_ERROR_OF_MEAN|0.48||0.0188|TWO_SIDED|95.0|0.19|2.08|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 6 months between Treatment vs Control group.||2.08|0.19|0.0188
71795344|NCT03387813|143087968|SUPERIORITY||Least Square Means Difference (T vs C)|0.63|STANDARD_ERROR_OF_MEAN|0.66||0.3405|TWO_SIDED|95.0|-0.66|1.92|||Mixed Models Analysis|||Comparisons of PA Systolic Pressure at 12 months between Treatment vs Control group.||1.92|-0.66|0.3405
71795345|NCT03387813|143087968|SUPERIORITY||Least Square Means Difference (T vs C)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6174|TWO_SIDED|95.0|-0.59|0.99|||Mixed Models Analysis|||Comparisons of PA Diastolic Pressure at 12 months between Treatment vs Control group.||0.99|-0.59|0.6174
71795346|NCT03387813|143087968|SUPERIORITY||Least Square Means Difference (T vs C)|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.4231|TWO_SIDED|95.0|-0.58|1.38|||Mixed Models Analysis|||Comparisons of PA Mean Pressure at 12 months between Treatment vs Control group.||1.38|-0.58|0.4231
71795347|NCT03387813|143087969|SUPERIORITY|||||||0.0214|||||||t-test, 2 sided|||Comparison of PA Systolic Pressure AUC between Treatment and Control group.||||0.0214
71795348|NCT03387813|143087969|OTHER|||||||0.1002|||||||t-test, 2 sided|||Comparison of PA Diastolic Pressure AUC between Treatment and Control group.||||0.1002
71795349|NCT03387813|143087969|OTHER|||||||0.0402|||||||t-test, 2 sided|||Comparison of PA Mean Pressure AUC between Treatment and Control group.||||0.0402
71795350|NCT03387813|143087970|SUPERIORITY||Least Square Means Difference (T vs C)|37.19|STANDARD_ERROR_OF_MEAN|75.52||0.6227|TWO_SIDED|95.0|-111.38|185.77|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 6 months between Treatment vs Control group||185.77|-111.38|0.6227
71795351|NCT03387813|143087971|SUPERIORITY||Least Square Means Difference (T vs C)|59.78|STANDARD_ERROR_OF_MEAN|76.87||0.4373|TWO_SIDED|95.0|-91.44|211.01|||Mixed Models Analysis|||Comparisons of change from baseline in BNP levels at 12 months between Treatment vs Control group||211.01|-91.44|0.4373
71795352|NCT03387813|143087972|SUPERIORITY||Least Square Means Difference (T vs C)|468.1|STANDARD_ERROR_OF_MEAN|256.65||0.0692|TWO_SIDED|95.0|-37.09|973.3|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 6months between Treatment vs Control group||973.30|-37.09|0.0692
71795353|NCT03387813|143087973|SUPERIORITY||Least Square Means Difference (T vs C)|284.67|STANDARD_ERROR_OF_MEAN|268.72||0.2903|TWO_SIDED|95.0|-244.27|813.6|||Mixed Models Analysis|||Comparisons of change from baseline in NT-proBNP levels at 12 months between Treatment vs Control group||813.60|-244.27|0.2903
71795354|NCT03387813|143087974|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.78|||Anderson-Gill model (robust sandwich)|||||0.78|0.53|<0.0001
71795355|NCT03387813|143087975|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.0|0.57|0.81|||Anderson-Gill model (robust sandwich)|||||0.81|0.57|<0.0001
71795356|NCT04534764|143087997|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|-0.016|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.039|0.006|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|High Luminance Low Contrast||0.006|-0.039|
71795357|NCT04534764|143087997|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least Square Mean Difference|0.009|STANDARD_ERROR_OF_MEAN|0.0114|||TWO_SIDED|95.0|-0.014|0.031|||Mixed Models Analysis||LS Mean difference was calculated as Test - Control.|Low Luminance High Contrast||0.031|-0.014|
71840018|NCT01152450|143188624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.323|STANDARD_ERROR_OF_MEAN|0.769||0.6747||95.0|-1.195|1.841|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||1.841|-1.195|0.6747
71673464|NCT05870371|142865057|OTHER||Mean Difference (Net)|5.48|||<|0.039|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Extension average.|Null hypothesis: The application of ATM does not affect the cervical range of motion (ROM) recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain (secondary hypothesis).||||<0.039
71673465|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.001|TWO_SIDED|||||The above p-value corresponds to the Rotation maximum. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.001
71673466|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-5.0|STANDARD_ERROR_OF_MEAN|1.51|=|0.002|TWO_SIDED||||||Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rotation average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.002
71795358|NCT03583996|143087998|OTHER||Negative Likelihood Ratio (NLR)|0.293|||||TWO_SIDED|95.0|0.097|0.882||||||The performance goal for validation of DSI ≤18.3 was the upper limit of the confidence interval (CI) for negative likelihood ratio (NLR) to rule out an NLR of \>0.52. For the null and alternate hypotheses, the upper limit of the 95% CI was NLR \>0.52 and the upper limit of the 95% CI was NLR \<=0.52, respectively. The confidence level for the CI was adjusted to maintain a 1-sided type I error rate of 0.025.||0.882|0.097|
71795359|NCT03583996|143087998|OTHER||Sensitivity|0.917|||||TWO_SIDED|95.0|0.775|0.982||||||The performance goal for validation of DSI \<= 18.3 was the observed sensitivity must have been \>0.85. The confidence level for the confidence interval (CI) was adjusted to maintain a 1-sided type I error rate of 0.025.||0.982|0.775|
71795360|NCT03583996|143087999|OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.047|1.143||The odds ratio was for a 1-unit increase in DSI based on continuous DSI.|Regression, Logistic|Unadjusted (no covariates)||||1.143|1.047|<0.0001
71795361|NCT03583996|143087999|OTHER||Odds Ratio (OR)|1.109|||<|0.0001|TWO_SIDED|95.0|1.058|1.163|||Regression, Logistic|Adjusted for demographic covariates, including age, race, sex, BMI, and ethnicity.||||1.163|1.058|<0.0001
71795362|NCT03583996|143087999|OTHER||Odds Ratio (OR)|1.092|||<|0.001|TWO_SIDED|95.0|1.041|1.145|||Regression, Logistic|Adjusted for severity of liver disease covariates, compensated cirrhosis (CP class A)||||1.145|1.041|<0.001
71795363|NCT03583996|143087999|OTHER||Odds Ratio (OR)|1.089|||<|0.001|TWO_SIDED|95.0|1.038|1.142|||Regression, Logistic|Adjusted for severity of liver disease covariates, decompensated cirrhosis (CP class B)||||1.142|1.038|<0.001
71795364|NCT03161483|143088000|SUPERIORITY||Stratified difference|11.4||||0.214|TWO_SIDED|95.0|-6.57|29.0|||Cochran-Mantel-Haenszel|||||29.00|-6.57|0.214
71795365|NCT03161483|143088000|SUPERIORITY||Stratified difference|5.0||||0.512|TWO_SIDED|95.0|-9.77|19.48|||Cochran-Mantel-Haenszel|||||19.48|-9.77|0.512
71795366|NCT03161483|143088000|SUPERIORITY||Stratified difference|19.4||||0.011|TWO_SIDED|95.0|4.12|33.42|||Cochran-Mantel-Haenszel|||||33.42|4.12|0.011
71795367|NCT03161483|143088001|SUPERIORITY||Stratified difference|10.3||||0.264|TWO_SIDED|95.0|-7.66|27.97|||Cochran-Mantel-Haenszel|||||27.97|-7.66|0.264
71795368|NCT03161483|143088001|SUPERIORITY||Stratified difference|6.5||||0.399|TWO_SIDED|95.0|-8.45|21.0|||Cochran-Mantel-Haenszel|||||21.00|-8.45|0.399
71795369|NCT03161483|143088001|SUPERIORITY||Stratified difference|19.3||||0.012|TWO_SIDED|95.0|4.01|33.36|||Cochran-Mantel-Haenszel|||||33.36|4.01|0.012
71795370|NCT03161483|143088002|SUPERIORITY||Stratified difference|24.0||||0.446|TWO_SIDED|95.0|-12.38|53.11|||Cochran-Mantel-Haenszel|||||53.11|-12.38|0.446
71795371|NCT03161483|143088002|SUPERIORITY||Stratified difference|5.3|||>|0.999|TWO_SIDED|95.0|-27.64|39.38|||Cochran-Mantel-Haenszel|||||39.38|-27.64|>0.999
71795372|NCT03161483|143088002|SUPERIORITY||Stratified difference|14.2||||0.488|TWO_SIDED|95.0|-19.54|44.48|||Cochran-Mantel-Haenszel|||||44.48|-19.54|0.488
71795373|NCT03161483|143088003|SUPERIORITY||Stratified difference|12.4||||0.092|TWO_SIDED|95.0|-2.74|24.07|||Cochran-Mantel-Haenszel|||||24.07|-2.74|0.092
71795374|NCT03161483|143088003|SUPERIORITY||Stratified difference|-5.3||||0.434|TWO_SIDED|95.0|-18.43|8.06|||Cochran-Mantel-Haenszel|||||8.06|-18.43|0.434
71795375|NCT03161483|143088003|SUPERIORITY||Stratified difference|8.0||||0.182|TWO_SIDED|95.0|-3.88|19.65|||Cochran-Mantel-Haenszel|||||19.65|-3.88|0.182
71795376|NCT03161483|143088004|SUPERIORITY||Stratified difference|12.1||||0.098|TWO_SIDED|95.0|-2.98|23.78|||Cochran-Mantel-Haenszel|||||23.78|-2.98|0.098
71795377|NCT03161483|143088004|SUPERIORITY||Stratified difference|-4.3||||0.521|TWO_SIDED|95.0|-17.36|8.92|||Cochran-Mantel-Haenszel|||||8.92|-17.36|0.521
71795378|NCT03161483|143088004|SUPERIORITY||Stratified difference|6.8||||0.267|TWO_SIDED|95.0|-5.24|18.55|||Cochran-Mantel-Haenszel|||||18.55|-5.24|0.267
71795379|NCT03161483|143088005|SUPERIORITY||Difference in adjusted mean|0.7||||0.116|TWO_SIDED|95.0|-0.2|1.5|||longitudinal data analysis model|||||1.5|-0.2|0.116
71795380|NCT03161483|143088005|SUPERIORITY||Difference in adjusted mean|0.7||||0.094|TWO_SIDED|95.0|-0.1|1.6|||longitudinal data analysis model|||||1.6|-0.1|0.094
71795381|NCT03161483|143088005|SUPERIORITY||Difference in adjusted mean|0.1||||0.881|TWO_SIDED|95.0|-0.6|0.8|||longitudinal data analysis model|||||0.8|-0.6|0.881
71795382|NCT03161483|143088006|SUPERIORITY||Difference in adjusted mean|1.1||||0.16|TWO_SIDED|95.0|-0.4|2.6|||longitudinal data analysis model|||||2.6|-0.4|0.160
71795383|NCT03161483|143088006|SUPERIORITY||Difference in adjusted mean|1.3||||0.056|TWO_SIDED|95.0|0.0|2.6|||longitudinal data analysis model|||||2.6|0.0|0.056
71840019|NCT01152450|143188624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.389|STANDARD_ERROR_OF_MEAN|0.774||0.6159||95.0|-1.138|1.916|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||1.916|-1.138|0.6159
71795384|NCT03161483|143088006|SUPERIORITY||Difference in adjusted mean|0.3||||0.621|TWO_SIDED|95.0|-1.0|1.6|||longitudinal data analysis model|||||1.6|-1.0|0.621
71795385|NCT03161483|143088008|SUPERIORITY||Difference in adjusted mean|-1.1||||0.546|TWO_SIDED|95.0|-4.7|2.5|||longitudinal data analysis model|||||2.5|-4.7|0.546
71795386|NCT03161483|143088008|SUPERIORITY||Difference in adjusted mean|-0.6||||0.681|TWO_SIDED|95.0|-3.7|2.4|||longitudinal data analysis model|||||2.4|-3.7|0.681
71795387|NCT03161483|143088008|SUPERIORITY||Difference in adjusted mean|1.4||||0.35|TWO_SIDED|95.0|-1.6|4.4|||longitudinal data analysis model|||||4.4|-1.6|0.350
71795388|NCT03161483|143088009|SUPERIORITY|\<= 7.5 mg/day|Stratified difference|0.2|||>|0.999|TWO_SIDED|95.0|-15.13|15.91|||longitudinal data analysis model|||||15.91|-15.13|>0.999
71795389|NCT03161483|143088009|SUPERIORITY|\< 10 mg/day|Stratified difference|-3.2|||>|0.999|TWO_SIDED|95.0|-17.74|13.0|||longitudinal data analysis model|||||13.00|-17.74|>0.999
71840020|NCT01152450|143188624|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.777||||95.0|-1.468|1.599|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||1.599|-1.468|
71795390|NCT03161483|143088010|SUPERIORITY||Difference in adjusted means|2.8||||0.535|TWO_SIDED|95.0|-6.0|11.6|||longitudinal data analysis model|||||11.6|-6.0|0.535
71795391|NCT03161483|143088010|SUPERIORITY||Difference in adjusted means|4.2||||0.309|TWO_SIDED|95.0|-3.9|12.2|||longitudinal data analysis model|||||12.2|-3.9|0.309
71795392|NCT03161483|143088010|SUPERIORITY||Difference in adjusted means|6.5||||0.091|TWO_SIDED|95.0|-1.0|14.1|||longitudinal data analysis model|||||14.1|-1.0|0.091
71795393|NCT02404350|143088026|SUPERIORITY||Odds Ratio (OR)|4.02|||<|0.0001|TWO_SIDED|95.0|2.78|5.79|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||5.79|2.78|<0.0001
71795394|NCT02404350|143088026|SUPERIORITY||Odds Ratio (OR)|3.38|||<|0.0001|TWO_SIDED|95.0|2.35|4.87|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||4.87|2.35|<0.0001
71795395|NCT02404350|143088026|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.0001|TWO_SIDED|95.0|3.16|6.63|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.||6.63|3.16|<0.0001
71795396|NCT02404350|143088027|SUPERIORITY||Difference in Mean|-0.61|STANDARD_ERROR_OF_MEAN|0.22||0.0061|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0061
71795397|NCT02404350|143088027|SUPERIORITY||Difference in Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.13||0.0048|TWO_SIDED||||||Non-parametric ANCOVA model||\*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0048
71795398|NCT02404350|143088027|SUPERIORITY||Difference in Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0003|||||||Non-parametric ANCOVA model||For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.||||0.0003
71795399|NCT02404350|143088028|SUPERIORITY||Odds Ratio (OR)|10.15|||<|0.0001|TWO_SIDED|95.0|5.52|18.63|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||18.63|5.52|<0.0001
71795400|NCT02404350|143088028|SUPERIORITY||Odds Ratio (OR)|11.66|||<|0.0001|TWO_SIDED|95.0|6.37|21.37|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||21.37|6.37|<0.0001
71795401|NCT02404350|143088028|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|9.56|34.12|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||34.12|9.56|<0.0001
71840021|NCT01152450|143188625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.142||0.5906||95.0|-0.358|0.204|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.204|-0.358|0.5906
71893068|NCT00702143|143307317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||<0.0001
71893069|NCT00702143|143307317|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups||||0.0014
71795402|NCT02404350|143088029|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.31|8.83|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||8.83|2.31|<0.0001
71795403|NCT02404350|143088029|SUPERIORITY||Odds Ratio (OR)|6.14|||<|0.0001|TWO_SIDED|95.0|3.18|11.87|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||11.87|3.18|<0.0001
71795404|NCT02404350|143088029|SUPERIORITY||Odds Ratio (OR)|12.55|||<|0.0001|TWO_SIDED|95.0|6.43|24.48|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."||24.48|6.43|<0.0001
71795405|NCT02404350|143088030|SUPERIORITY||Odds Ratio, log|5.37|||<|0.0001|TWO_SIDED|95.0|3.3|8.73|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||8.73|3.30|<0.0001
71795406|NCT02404350|143088030|SUPERIORITY||Odds Ratio (OR)|6.37|||<|0.0001|TWO_SIDED|95.0|3.93|10.32|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||10.32|3.93|<0.0001
71795407|NCT02404350|143088030|SUPERIORITY||Odds Ratio (OR)|7.43|||<|0.0001|TWO_SIDED|95.0|4.61|12.0|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.||12.00|4.61|<0.0001
71795408|NCT02404350|143088031|SUPERIORITY|Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|Treatment contrast in LS mean (Change)|-0.24|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.15|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.15|-0.32|<0.0001
71795409|NCT02404350|143088031|SUPERIORITY||Treatment Contrast in LS mean (Change)|-0.23|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.32|-0.14|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.14|-0.32|<0.0001
71795410|NCT02404350|143088031|SUPERIORITY||Treatment Contrast inj LS mean (Change)|-0.33|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|-0.42|-0.24|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)||||-0.24|-0.42|<0.0001
71795411|NCT02404350|143088032|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
71795412|NCT02404350|143088032|SUPERIORITY||Treatment Contrast in LS Mean (Change)|-0.66|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.47|-0.85|<0.0001
71795413|NCT02404350|143088032|SUPERIORITY||Treatment contrast in LS mean (Change)|-0.86|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.05|-0.67|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure||-0.67|-1.05|<0.0001
71795414|NCT02404350|143088033|SUPERIORITY||Odds Ratio (OR)|0.75||||0.225|TWO_SIDED|95.0|0.47|1.19|||Regression, Logistic|||||1.19|0.47|0.2250
71795415|NCT02404350|143088033|SUPERIORITY||Odds Ratio (OR)|0.45||||0.0004|TWO_SIDED|95.0|0.29|0.7|||Regression, Logistic|||||0.70|0.29|0.0004
71795416|NCT02404350|143088033|SUPERIORITY||Odds Ratio, log|0.44||||0.0004|TWO_SIDED|95.0|0.28|0.69|||Regression, Logistic|||||0.69|0.28|0.0004
71795417|NCT02404350|143088034|SUPERIORITY||Odds Ratio (OR)|0.37||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Regression, Logistic|||||0.65|0.22|0.0004
71795418|NCT02404350|143088034|SUPERIORITY||Odds Ratio (OR)|0.34||||0.0003|TWO_SIDED|95.0|0.19|0.6|||Regression, Logistic|||||0.60|0.19|0.0003
71795419|NCT02404350|143088034|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.44|||Regression, Logistic|||||0.44|0.13|<0.0001
71795420|NCT05389657|143088048|SUPERIORITY||Odds Ratio (OR)|0.617||||0.47|TWO_SIDED|95.0|0.167|2.283|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on training completion, with a random intercept at the agency level. Covariates included prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||2.283|0.167|0.47
71795421|NCT05389657|143088049|SUPERIORITY||adjusted group difference unstandardized|-1.268||||0.29|TWO_SIDED|95.0|-3.618|1.083|||Regression, Linear|multilevel linear regression with restricted maximum likelihood (REML) estimation||We used linear multilevel models with restricted maximum likelihood (REML) estimation to examine the impact of training assignment (reference = live training) on knowledge acquisition at post-training, with a random intercept at the agency level. Covariates included baseline FBT-KA score, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||1.083|-3.618|.29
71673467|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-4.84|STANDARD_ERROR_OF_MEAN|1.6|=|0.048|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.048
71673468|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-2.0|STANDARD_ERROR_OF_MEAN|1.06|=|0.059|TWO_SIDED|||||The above p value corresponds to the Lateral Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Lateral Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.059
71673469|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-0.92|STANDARD_ERROR_OF_MEAN|1.62|=|0.57|TWO_SIDED|||||The above p value corresponds to the Flexion maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion maximum. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.57
71673470|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-0.14|STANDARD_ERROR_OF_MEAN|1.65|=|0.931|TWO_SIDED|||||The above p value corresponds to the Flexion average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Flexion average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.931
71673471|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-1.17|STANDARD_ERROR_OF_MEAN|1.99|=|0.558|TWO_SIDED|||||The above p value corresponds to the Extension maximum. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension maximum . The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.558
71673472|NCT05870371|142865057|OTHER||Dependence coefficient (β)|-0.03|STANDARD_ERROR_OF_MEAN|1.96|=|0.989|TWO_SIDED|||||The above p value corresponds to the Extension average. The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Extension average. The above values correspond to the comparison which is between groups at baseline.|Null hypothesis: The effect of the application of ATM does not differ in the improvement of the cervical ROM recorded with the Moover three-dimensional (3D) Inertial Motion sensor in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.989
71673473|NCT05870371|142865058|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null hypothesis: The application of ATM does not affect the strength of deep neck flexor muscles as measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
71673474|NCT05870371|142865058|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.01|=|0.437|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of applying ATM does not differ in improving the strength of deep neck flexor muscles measured by the Chattanooga Stabilizer Pressure Biofeedback in patients with chronic neck pain than applying A-S (secondary hypothesis).||||=0.437
71795422|NCT05389657|143088050|SUPERIORITY||Odds Ratio (OR)|1.16||||0.92|TWO_SIDED|95.0|0.07|19.293|||Regression, Logistic|multilevel logistic regression||We used logistic multilevel models to examine the impact of training assignment (reference = live training) on engagement in FBT consultation at 12 months, with a random intercept at the agency level. Covariates included baseline intent to seek FBT consultation, prior level of training and/or experience in FBT, attitudes towards evidence-based practice (MPAS), perceived importance of eating disorder treatment to organization, and training preference.||19.293|0.070|0.92
71795423|NCT01907828|143088051|OTHER|||||||0.22|||||||Log Rank|||Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.||||0.22
71795424|NCT01907828|143088055|SUPERIORITY|||||||0.2766|||||||Paired Student's t-test|||||||0.2766
71795425|NCT01907828|143088056|SUPERIORITY|||||||0.7663|||||||Wilcoxon signed-rank test|||||||0.7663
71795426|NCT01907828|143088059|SUPERIORITY||Mean Difference (Final Values)|-5.86|STANDARD_DEVIATION|15.21||0.0849|TWO_SIDED|95.0|-12.61|0.88|||Paired Student's t-test|||Change in ASBP at 12 months||0.88|-12.61|0.0849
71795427|NCT01907828|143088059|SUPERIORITY||Mean Difference (Final Values)|-5.82|STANDARD_DEVIATION|7.45||0.0014|TWO_SIDED|95.0|-9.12|-2.52|||Paired Student's t-test|||Change in ADBP at 12 months||-2.52|-9.12|0.0014
71795428|NCT01907828|143088059|SUPERIORITY||Mean Difference (Final Values)|-3.07|STANDARD_DEVIATION|19.21||0.5599|TWO_SIDED|95.0|-14.16|8.02|||Paired Student's t-test|||Change in ASBP at 12 months.||8.02|-14.16|0.5599
71795429|NCT01907828|143088059|SUPERIORITY||Mean Difference (Final Values)|-8.43|STANDARD_DEVIATION|9.42||0.0052|TWO_SIDED|95.0|-13.87|-2.99|||Paired Student's t-test|||Change in ADBP at 12 months||-2.99|-13.87|0.0052
71795430|NCT01907828|143088060|SUPERIORITY||Mean Difference (Final Values)|-5.71|STANDARD_DEVIATION|14.84||0.1326|TWO_SIDED|95.0|-13.34|1.93|||Paired Student's t-test|||Change in ASBP at 24 months||1.93|-13.34|0.1326
71795431|NCT01907828|143088060|SUPERIORITY||Mean Difference (Final Values)|-6.94|STANDARD_DEVIATION|6.06||0.0002|TWO_SIDED|95.0|-10.06|-3.83|||Paired Student's t-test|||Change in ADBP at 24 months||-3.83|-10.06|0.0002
71795432|NCT01907828|143088060|SUPERIORITY||Mean Difference (Final Values)|-8.58|STANDARD_DEVIATION|12.41||0.0354|TWO_SIDED|95.0|-16.47|-0.7|||Paired Student's t-test|||Change in ASBP at 24 months||-0.70|-16.47|0.0354
71795433|NCT01907828|143088060|SUPERIORITY||Mean Difference (Final Values)|-10.33|STANDARD_DEVIATION|8.53||0.0015|TWO_SIDED|95.0|-15.75|-4.91|||Paired Student's t-test|||Change in ADBP at 24 months||-4.91|-15.75|0.0015
71795434|NCT01907828|143088061|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|24.4||0.5399|TWO_SIDED|95.0|-6.0|11.3|||Paired Student's t-test|||Change in OSBP at 12 months.||11.3|-6.0|0.5399
71795435|NCT01907828|143088061|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|11.8||0.8489|TWO_SIDED|95.0|-4.6|3.8|||Paired Student's t-test|||Change in Office Diastolic Blood Pressure (ODBP) at 12 months||3.8|-4.6|0.8489
71795436|NCT01907828|143088061|SUPERIORITY|Change in Office Systolic Blood Pressure (OSBP) at 12 months.|Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|30.0||0.7999|TWO_SIDED|95.0|-14.6|18.6|||Paired Student's t-test|||||18.6|-14.6|0.7999
71795437|NCT01907828|143088061|SUPERIORITY||Mean Difference (Final Values)|-5.4|STANDARD_DEVIATION|15.8||0.2076|TWO_SIDED|95.0|-14.2|3.4|||Paired Student's t-test|||Change in ODBP at 12 months||3.4|-14.2|0.2076
71795438|NCT01907828|143088062|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|22.3||0.882|TWO_SIDED|95.0|-7.9|9.1|||Paired Student's t-test|||Change in OSBP at 24 months||9.1|-7.9|0.8820
71795439|NCT01907828|143088062|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|11.0||0.8019|TWO_SIDED|95.0|-3.7|4.7|||Paired Student's t-test|||Change in ODBP at 24 months||4.7|-3.7|0.8019
71795440|NCT01907828|143088062|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_DEVIATION|22.9||0.2177|TWO_SIDED|95.0|-4.8|19.6|||Paired Student's t-test|||Change in OSBP at 24 months||19.6|-4.8|0.2177
71795441|NCT01907828|143088062|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|15.5||0.4502|TWO_SIDED|95.0|-11.2|5.2|||Paired Student's t-test|||Change in ODBP at 24 months||5.2|-11.2|0.4502
71795442|NCT04414553|143088077|SUPERIORITY|||||||0.29||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This compares pre/post data.||||0.29
71795443|NCT04414553|143088078|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
71795444|NCT04414553|143088079|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
71795445|NCT04414553|143088080|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
71795446|NCT04414553|143088081|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||||||0.062
71795447|NCT00591942|143088082|NON_INFERIORITY|95% CI were used|KM Survival Curves|0.5637||||0.5637|TWO_SIDED||||||Chi-squared|df=1||||||0.5637
71795448|NCT05544786|143088083|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.13|||||TWO_SIDED|90.0|102.77|124.53|||||The ratios (and 90% confidence Intervals \[CIs\]) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||124.53|102.77|
71795449|NCT05544786|143088083|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.91|||||TWO_SIDED|90.0|110.75|134.2|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||134.20|110.75|
71795450|NCT05544786|143088083|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|125.49|||||TWO_SIDED|90.0|114.43|137.61|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||137.61|114.43|
71795451|NCT05544786|143088083|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|121.09|||||TWO_SIDED|90.0|110.42|132.79|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||132.79|110.42|
71795452|NCT05544786|143088084|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|113.62|||||TWO_SIDED|90.0|102.96|125.4|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||125.40|102.96|
71795453|NCT05544786|143088084|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.53|||||TWO_SIDED|90.0|111.02|135.22|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||135.22|111.02|
71840022|NCT01152450|143188625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.143||0.2208||95.0|-0.458|0.106|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.106|-0.458|0.2208
71795454|NCT05544786|143088084|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|126.55|||||TWO_SIDED|90.0|115.0|139.27|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||139.27|115.00|
71795455|NCT05544786|143088084|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|122.28|||||TWO_SIDED|90.0|111.11|134.57|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||134.57|111.11|
71840023|NCT01152450|143188625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.143||||95.0|-0.382|0.184|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.184|-0.382|
71840024|NCT01152450|143188626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.082||0.9797||95.0|-0.163|0.159|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.159|-0.163|0.9797
71840025|NCT01152450|143188626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.082||0.4518||95.0|-0.223|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.100|-0.223|0.4518
71840026|NCT01152450|143188626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.082||||95.0|-0.222|0.102|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.102|-0.222|
71840027|NCT01152450|143188627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.074||0.4089||95.0|-0.207|0.085|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.085|-0.207|0.4089
71840028|NCT01152450|143188627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.074|STANDARD_ERROR_OF_MEAN|0.074||0.3185||95.0|-0.221|0.072|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.072|-0.221|0.3185
71840029|NCT01152450|143188627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.074||||95.0|-0.16|0.134|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.134|-0.160|
71840030|NCT01152450|143188628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031||0.9626||95.0|-0.059|0.062|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo|||0.062|-0.059|0.9626
71840031|NCT01152450|143188628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.031||0.9102||95.0|-0.058|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo|||0.065|-0.058|0.9102
71840032|NCT01152450|143188628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.031||||95.0|-0.059|0.063|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Tio R2.5 bid|||0.063|-0.059|
71840033|NCT05670587|143188630|OTHER||gMean ratio at Week 4|0.95|||||TWO_SIDED|95.0|0.76|1.18|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric Coefficient of variation (gCV) = 84.59%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 4.||1.18|0.76|
71893070|NCT00702143|143307319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||<0.0001
71840034|NCT05670587|143188630|OTHER||gMean ratio at Week 8|0.84|||||TWO_SIDED|95.0|0.64|1.11|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 115.62%"|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Week 8.||1.11|0.64|
71840035|NCT05670587|143188630|OTHER||gMean ratio at Day 82|0.98|||||TWO_SIDED|95.0|0.75|1.29|||||"gMean ratios of CfB in CC/h were calculated from the log transformed values at each visit.~Geometric coefficient of variation (gCV) = 100.02%."|Geometric mean (gMean) ratio of change from baseline (CfB) in cough count per hour (CC/h) at Day 82.||1.29|0.75|
71840036|NCT04947527|143188638|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.279|TWO_SIDED|95.0|-4.2|1.2|||t-test, 2 sided|||||1.2|-4.2|0.279
71840037|NCT04947527|143188639|SUPERIORITY||Difference in percentages/proportions|-14.4||||0.023|TWO_SIDED|95.0|-26.7|-2.1|||Chi-squared|||||-2.1|-26.7|0.023
71840038|NCT04947527|143188640|SUPERIORITY||Risk Difference (RD)|-0.09||||0.133|TWO_SIDED||||||Fisher Exact|||||||0.133
71840039|NCT02723591|143188641|SUPERIORITY||Odds Ratio (OR)|1.115||||0.5777|TWO_SIDED|95.0|0.76|1.636|||Regression, Logistic|||Logistic regression with DSA/IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant calculated panel reactivity antibody (cPRA) as fixed effects, and pooled site as a random effect with standard variance components covariance type.||1.636|0.760|0.5777
71840040|NCT02723591|143188644|SUPERIORITY|||||||0.6618|||||||Fisher Exact|||P-values obtained from a 2x3 Exact Test of treatment by strength levels.||||0.6618
71840041|NCT02723591|143188649|SUPERIORITY||Odds Ratio (OR)|1.038||||0.8518|TWO_SIDED|95.0|0.7|1.539|||Regression, Logistic|||Logistic regression with IA occurrence by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||1.539|0.700|0.8518
71840042|NCT02723591|143188652|SUPERIORITY|||||||1|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||1.0000
71840043|NCT02723591|143188653|SUPERIORITY|||||||0.475|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.4750
71840044|NCT02723591|143188654|SUPERIORITY|||||||0.0939|||||||Fisher Exact|||P-values obtained from a 2-sided Fisher's Exact Test of treatment arm by response.||||0.0939
71893071|NCT00702143|143307319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
71673475|NCT05870371|142865059|OTHER||Mean Difference (Net)|0.02|||=|0.919|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.919
71673476|NCT05870371|142865059|OTHER||Dependence coefficients (β)|-0.05|STANDARD_ERROR_OF_MEAN|0.02|=|0.01|TWO_SIDED|||||The above value corresponds to the comparison between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis||The above value corresponds to the comparison between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.010
71673477|NCT05870371|142865060|OTHER||Mean Difference (Net)|0.09|||=|0.659|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.659
71673478|NCT05870371|142865060|OTHER||Dependence coefficient (β)|-0.04|STANDARD_ERROR_OF_MEAN|0.02|=|0.05|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.05
71673479|NCT05870371|142865061|OTHER||Mean Difference (Net)|10.28|||=|0.09|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the respiratory function assessed by the portable spirometer (MIR Spirodoc) in patients with chronic neck pain (secondary hypothesis).||||=0.09
71673480|NCT05870371|142865061|OTHER||Dependence coefficient (β)|-0.06|STANDARD_ERROR_OF_MEAN|0.02|=|0.005|TWO_SIDED|||||The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of the respiratory function in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.005
71795456|NCT05544786|143088085|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|110.28|||||TWO_SIDED|90.0|99.01|122.82|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||122.82|99.01|
71795457|NCT05544786|143088085|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|140.97|||||TWO_SIDED|90.0|126.57|157.01|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||157.01|126.57|
71795458|NCT05544786|143088085|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|149.83|||||TWO_SIDED|90.0|132.86|168.96|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||168.96|132.86|
71893072|NCT00702143|143307319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||<0.0001
71893073|NCT00702143|143307319|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0003
71673481|NCT05870371|142865062|OTHER||Mean Difference (Net)|-7.87|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total McGill Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total McGill Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673482|NCT05870371|142865062|OTHER||Mean Difference (Net)|-5.55|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Sensory Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71795459|NCT05544786|143088085|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|147.05|||||TWO_SIDED|90.0|130.4|165.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||165.83|130.40|
71893074|NCT00741819|143307385|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.0|STANDARD_DEVIATION|35.9|<|0.001||95.0|||||Wilcoxon signed rank test]||Change in 6MWD from Baseline was calculated for patients still remaining on study at Week 12.|Analysis of endpoints was descriptive in nature. Numeric endpoints for post-baseline assessments were compared to Baseline using Wilcoxon signed rank test, and p-values were calculated for descriptive purposes; no formal hypothesis testing was planned.||||<0.001
71795460|NCT05544786|143088086|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|96.76|||||TWO_SIDED|90.0|87.31|107.23|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||107.23|87.31|
71795461|NCT05544786|143088086|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.86|||||TWO_SIDED|90.0|78.38|96.26|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||96.26|78.38|
71795462|NCT05544786|143088086|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|99.29|||||TWO_SIDED|90.0|87.39|112.8|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||112.80|87.39|
71795463|NCT05544786|143088086|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|79.29|||||TWO_SIDED|90.0|70.07|89.73|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||89.73|70.07|
71795464|NCT05544786|143088087|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|95.92|||||TWO_SIDED|90.0|86.45|106.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||106.44|86.45|
71795465|NCT05544786|143088087|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|86.5|||||TWO_SIDED|90.0|77.96|95.98|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||95.98|77.96|
71795466|NCT05544786|143088087|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|88.29|||||TWO_SIDED|90.0|72.97|106.83|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||106.83|72.97|
71795467|NCT05544786|143088087|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|77.49|||||TWO_SIDED|90.0|64.04|93.76|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||93.76|64.04|
71795468|NCT05544786|143088088|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with water (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|101.92|||||TWO_SIDED|90.0|87.71|118.44|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water (fasted)||118.44|87.71|
71795469|NCT05544786|143088088|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect for comparison: powder mixed with infant formula (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|92.4|||||TWO_SIDED|90.0|79.52|107.38|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with infant formula (fasted)||107.38|79.52|
71795470|NCT05544786|143088088|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fasted) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|97.04|||||TWO_SIDED|90.0|78.4|120.1|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted)||120.10|78.40|
71840045|NCT02723591|143188657|SUPERIORITY||Odds Ratio (OR)|1.431||||0.116|TWO_SIDED|95.0|0.915|2.24|||Regression, Logistic|||Logistic regression with occurrence of eGFR \< 50 by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.240|0.915|0.1160
71795471|NCT05544786|143088088|OTHER|The analysis used a mixed effect model with treatment as a fixed effect and participant as a random effect for comparison: powder mixed with vanilla pudding (fed) group versus tablets group.|Ratio (%) of Adjusted Geometric Mean|70.45|||||TWO_SIDED|90.0|56.92|87.19|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg tablets (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||87.19|56.92|
71893075|NCT00741819|143307386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|7.7|<|0.001|||||||Wilcoxon signed rank test||Analysis based on Total CAMPHOR Score.|||||<0.001
71893076|NCT00741819|143307387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|21.3||0.895||95.0|||||Wilcoxon signed-rank test||Side-Effects Score, change from Baseline to Week 12|||||0.895
71893077|NCT00741819|143307387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.3|STANDARD_DEVIATION|25.9|<|0.001||95.0|||||Wilcoxon signed-rank test||Convenience Score, change from Baseline to Week 12|||||<0.001
71795472|NCT05544786|143088089|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.5|||||TWO_SIDED|90.0|90.08|103.37|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.37|90.08|
71795473|NCT05544786|143088090|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|96.63|||||TWO_SIDED|90.0|90.13|103.59|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||103.59|90.13|
71795474|NCT05544786|143088091|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|98.15|||||TWO_SIDED|90.0|87.28|110.36|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.36|87.28|
71795475|NCT05544786|143088092|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|78.49|||||TWO_SIDED|90.0|72.42|85.07|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||85.07|72.42|
71795476|NCT05544786|143088093|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|87.77|||||TWO_SIDED|90.0|69.45|110.92|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||110.92|69.45|
71795477|NCT05544786|143088094|OTHER|The analysis used a mixed effect model with sequence, period and treatment as fixed effects and participant within a sequence as a random effect.|Ratio (%) of Adjusted Geometric Mean|72.6|||||TWO_SIDED|90.0|56.87|92.68|||||The ratios (and 90% CIs) are expressed as percentages.|Reference: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fasted) Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding (fed)||92.68|56.87|
71795478|NCT01774786|143088125|SUPERIORITY|The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.|Hazard Ratio (HR)|0.84||||0.0565|TWO_SIDED|95.0|0.71|1.0||The actual p-value significance threshold required for OS was 0.0455, after alpha spent at the interim analysis was taken into account.|Stratified Log-Rank|Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|HR was calculated as pertuzumab arm vs. placebo arm.|Primary Analysis. The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.||1.00|0.71|0.0565
71795479|NCT01774786|143088125|OTHER|Exploratory|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.72|0.99|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.99|0.72|
71795480|NCT01774786|143088126|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.86||As pre-specified in the protocol, a p-value was only to be calculated for PFS if OS was statistically significant.|||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Primary Analysis||0.86|0.62|
71795481|NCT01774786|143088126|OTHER|Exploratory|Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.62|0.85|||||A stratified Cox proportional hazards regression model was used to estimate the HR between the pertuzumab arm vs. the placebo arm.|Final Analysis||0.85|0.62|
71840046|NCT02723591|143188658|SUPERIORITY||Odds Ratio (OR)|1.212||||0.4995|TWO_SIDED|95.0|0.693|2.12|||Regression, Logistic|||Logistic regression with occurrence of 5-point eGFR decline by Month 12 as response, with treatment group, planned Campath use, KDPI level (as recorded in IVRS), HLA Class II mismatch, recipient age, recipient gender, recipient race, and pre-transplant cPRA as fixed effects, and pooled site as a random effect with standard Variance Components covariance type.||2.120|0.693|0.4995
71795482|NCT01774786|143088127|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Primary Analysis of Objective Response Rate||15.91|0.89|
71795483|NCT01774786|143088127|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Primary Analysis of Objective Response Rate||1.89|1.04|
71795484|NCT01774786|143088128|OTHER|Exploratory|Difference in Objective Response|8.4|||||TWO_SIDED|95.0|0.89|15.91|||||Difference in objective response was calculated as the pertuzumab arm minus placebo arm.|Final Analysis of Objective Response Rate||15.91|0.89|
71795485|NCT01774786|143088128|OTHER|Exploratory|Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.04|1.89|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|Final Analysis of Objective Response Rate||1.89|1.04|
71795486|NCT01774786|143088129|OTHER|Exploratory|Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.64|1.06|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Primary Analysis||1.06|0.64|
71795487|NCT01774786|143088129|OTHER|Exploratory|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|0.98|||||HR was calculated as pertuzumab arm vs. placebo arm. Stratified analysis by geographic region, HER2 status, and prior gastrectomy.|Final Analysis||0.98|0.62|
71795488|NCT01774786|143088130|OTHER|Exploratory|Difference in Clinical Benefit Rate|3.37|||||TWO_SIDED|95.0|-2.34|9.07|||||Difference in clinical benefit rate was calculated as the pertuzumab arm minus placebo arm.|||9.07|-2.34|
71795489|NCT01774786|143088130|OTHER|Exploratory|Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.88|||||Odds ratio was calculated as the pertuzumab arm vs. placebo arm.|||1.88|0.86|
71795490|NCT04903249|143088153|OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
71795491|NCT04903249|143088154|OTHER|||||||0.293|||||||t-test, 2 sided|||||||0.293
71795492|NCT04903249|143088155|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
71795493|NCT04903249|143088161|OTHER|||||||0.025|||||||t-test, 2 sided|||||||0.025
71795494|NCT04903249|143088162|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71795495|NCT04903249|143088163|OTHER|||||||0.327|||||||t-test, 2 sided|||||||.327
71673483|NCT05870371|142865062|OTHER||Mean Difference (Net)|-2.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Affective Score.|Null Hypothesis: The application of ATM does not affect the pain in the cervical spine in terms of its intensity and quality, i.e., its sensory, emotional and behavioral dimensions using the McGill Pain Questionnaire-short form (SFMPQ) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673484|NCT05870371|142865062|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.996|TWO_SIDED|||||The above p-value corresponds to the Total McGill score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.996
71795496|NCT04903249|143088164|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
71795497|NCT04903249|143088165|OTHER|||||||0.424|||||||t-test, 2 sided|||||||0.424
71795498|NCT04903249|143088166|OTHER|||||||0.279|||||||t-test, 2 sided|||||||0.279
71795499|NCT04903249|143088167|OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
71795500|NCT03556579|143088168|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.01|-0.36|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.36|-1.01|
71673485|NCT05870371|142865062|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.968|TWO_SIDED|||||The above p-value corresponds to the Sensory Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.968
71673486|NCT05870371|142865062|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.854|TWO_SIDED|||||The above p-value corresponds to the Affective Score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models. The above p-value corresponds to the comparison which is between groups at baseline.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of pain in terms of its intensity and quality in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.854
71795501|NCT03556579|143088168|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-1.45|-0.81|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|Without Distance Filter||-0.81|-1.45|
71795502|NCT03556579|143088169|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-8.86|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-13.16|-4.55|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-4.55|-13.16|
71795503|NCT03556579|143088169|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-24.93|STANDARD_ERROR_OF_MEAN|2.173|||TWO_SIDED|95.0|-29.24|-20.62|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-20.62|-29.24|
71795504|NCT03556579|143088170|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.15|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.15|
71795505|NCT03556579|143088171|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Ratio|0.55|||||TWO_SIDED|95.0|0.46|0.65|||Generalized linear mixed model|Generalized Linear mixed model with a lognormal distribution using the Kenward and Roger method for the denominator degrees of freedom.||||0.65|0.46|
71795506|NCT03556579|143088172|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.07|-0.15|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||-0.15|-1.07|
71795507|NCT03556579|143088173|SUPERIORITY|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|95.0|0.14|0.23|||Linear Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||0.23|0.14|
71673487|NCT05870371|142865063|OTHER||Mean Difference (Net)|-2.59|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||||||<0.001
71673488|NCT05870371|142865063|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.952|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.952
71795508|NCT03556579|143088174|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-30.56|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-31.66|-25.46|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|||-25.46|-31.66|
71795509|NCT03556579|143088174|SUPERIORITY|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-15.38|STANDARD_ERROR_OF_MEAN|2.555|||TWO_SIDED|95.0|-20.48|-10.27|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test Minus Control.|||-10.27|-20.48|
71673489|NCT05870371|142865064|OTHER||Mean Difference (Net)|-1.06|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.||||||<0.001
71673490|NCT05870371|142865064|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.02|=|0.989|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|||||=0.989
71673491|NCT05870371|142865065|OTHER||Mean Difference (Net)|-5.6|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the functionality recorded with the Neck Disability Index (NDI) in patients with chronic pain in the cervical spine (secondary hypothesis).||||<0.001
71673492|NCT05870371|142865065|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.03|=|0.973|TWO_SIDED|||||The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of functionality recorded with the Neck Disability Index (NDI) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.973
71673493|NCT05870371|142865066|OTHER||Mean Difference (Net)|-2.11|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Depression subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673494|NCT05870371|142865066|OTHER||Mean Difference (Net)|-2.05|||<|0.001|TWO_SIDED|||||The above value corresponds to the Anxiety subscale of HADS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above value corresponds to the Anxiety subscale of HADS.|Null Hypothesis: The application of ATM does not affect the anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673495|NCT05870371|142865066|OTHER||Dependence coefficient (β)|0.04|STANDARD_ERROR_OF_MEAN|0.04|=|0.305|TWO_SIDED|||||The above p-value corresponds to the Depression subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Depression subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.305
71813334|NCT01181726|143129091|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.01|||||TWO_SIDED|90.0|94.17|104.11|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.11|94.17|
71673496|NCT05870371|142865066|OTHER||Dependence coefficient (β)|0.05|STANDARD_ERROR_OF_MEAN|0.03|=|0.137|TWO_SIDED|||||The above p-value corresponds to the Anxiety subscale of HADS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|Log transformation was used for the mixed linear models.|The above values correspond to the Anxiety subscale of HADS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the reduction of anxiety and depression captured by the Hospital Anxiety \& Depression Scale (HADS) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.137
71813335|NCT01181726|143129092|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.13|||||TWO_SIDED|90.0|94.39|104.1|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.10|94.39|
71673497|NCT05870371|142865067|OTHER||Mean Difference (Net)|-3.82|||<|0.001|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.||Null Hypothesis: The application of ATM does not affect the kinesiophobia as measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673498|NCT05870371|142865067|OTHER||Dependence coefficient (β)|0.02|STANDARD_ERROR_OF_MEAN|0.01|=|0.151|TWO_SIDED|||||The threshold for statistical significance was p \< 0.05. The above value corresponds to the comparison which is between groups at baseline.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing kinesiophobia measured by the Tampa Scale Kinesiophobia (TSK\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.151
71795510|NCT00744627|143088179|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.81|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-5.74|-1.88||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||P-values were tested at the 5% level of significance (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-1.88|-5.74|<0.001
71795511|NCT00744627|143088180|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.555|<|0.001|TWO_SIDED|95.0|-3.39|-1.2||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis||||-1.20|-3.39|<0.001
71795512|NCT00744627|143088181|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.73|-0.19||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.19|-0.73|<0.001
71795513|NCT00744627|143088182|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.901||0.031|TWO_SIDED|95.0|-3.74|-0.18||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-0.18|-3.74|0.031
71795514|NCT00744627|143088183|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.393|||<|0.001|TWO_SIDED|95.0|1.496|3.83||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.||||3.830|1.496|<0.001
71795515|NCT00744627|143088184|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.267|<|0.001|TWO_SIDED|95.0|-7.61|-2.6||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||||-2.60|-7.61|<0.001
71795516|NCT00744627|143088185|SUPERIORITY_OR_OTHER||LS Mean Difference|8.78|STANDARD_ERROR_OF_MEAN|2.774||0.002|TWO_SIDED|95.0|3.32|14.25||SF-36 social functioning subscore was the last endpoint to be tested in the hierarchical testing sequence.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||Results presented are for the number of participants at week 8 only.||14.25|3.32|0.002
71795517|NCT00323492|143088222|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.42||||0.034||95.0|-0.86|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were applied.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.86|0.034
71795518|NCT00323492|143088223|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.36||||0.031||95.0|-0.67|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum text|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.03|-0.67|0.031
71840047|NCT02723591|143188676|SUPERIORITY|||||||0.6327|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6327
71673499|NCT05870371|142865067|OTHER||||||=|0.021||||||The threshold for statistical significance was p \< 0.05.|McNemar|||||||=0.021
71795519|NCT00323492|143088224|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.009||95.0|-0.18|-0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.02|-0.18|0.009
71795520|NCT00323492|143088225|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.64|||<|0.001||95.0|-1.01|-0.27||No adjustments for multiple comparisons were made.|Wicoxon Rank Sum test|no adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||-0.27|-1.01|< 0.001
71840048|NCT02723591|143188677|SUPERIORITY|||||||0.9701|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9701
71840049|NCT02723591|143188678|SUPERIORITY|||||||0.3127|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.3127
71795521|NCT00323492|143088226|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.1||||0.51||95.0|-0.44|0.19||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.19|-0.44|0.51
71795522|NCT00323492|143088227|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.79||95.0|-0.03|0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||0.02|-0.03|0.79
71795523|NCT00323492|143088228|SUPERIORITY_OR_OTHER|||||||0.86||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.86
71795524|NCT00323492|143088230|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).||||0.65
71795525|NCT00323492|143088231|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.11
71795526|NCT00323492|143088231|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.||||0.34
71795527|NCT00323492|143088232|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments were made.|Fisher Exact|No adjustments were made.||Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response||||1.00
71795528|NCT02530450|143088235|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Testing the change between two time points within each group using Wilcoxon signed rank test.||||< 0.05
71795529|NCT01538862|143088259|SUPERIORITY|||||||0.82|||||||Regression, Linear|||||||0.82
71795530|NCT01400516|143088262|SUPERIORITY||Median Difference (Final Values)|9.5||||0.28|TWO_SIDED|||||A p-value \< 0.05 is considered statistically significant.|Linear mixed model||control-teriparatide|||||0.28
71795531|NCT01412866|143088265|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|df=1||||||0.08
71840050|NCT02723591|143188679|SUPERIORITY|||||||0.083|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.0830
71795532|NCT00502697|143088315|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.||||.64
71795533|NCT00589108|143088345|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 2 years post-surgery.||||0.64
71795534|NCT00589108|143088345|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 5 years post-surgery.||||0.80
71795535|NCT00589108|143088346|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|||P-value for the difference for the Knee Society Function Score between the three groups at 5 years post-surgery.||||0.06
71795536|NCT00589108|143088347|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||P-value for the difference for the Knee Society Pain Score between the three groups at 5 years post-surgery.||||0.87
71795537|NCT00589108|143088348|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 2 years post-surgery.||||0.44
71795538|NCT00589108|143088348|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 5 years post-surgery.||||0.08
71795539|NCT00589108|143088349|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANOVA|||P-value for the difference between the percentage of knees surviving between the three groups at 5 years post-surgery.||||0.92
71795540|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795541|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795542|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795543|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795544|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795545|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795546|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795547|NCT03026257|143088350|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||<0.0001
71795548|NCT05228470|143088362|OTHER|Null hypothesis of ORR by BICR was 30%.||||||0.0076|||||||Exact binomial test|||||||0.0076
71840051|NCT02723591|143188680|SUPERIORITY|||||||0.6022|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.6022
71840052|NCT02723591|143188681|SUPERIORITY|P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||||0.9249|||||||Fisher Exact|||||||0.9249
71840053|NCT02723591|143188682|SUPERIORITY|||||||0.9136|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.9136
71840054|NCT02723591|143188683|SUPERIORITY|||||||0.8789|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8789
71840055|NCT02723591|143188684|SUPERIORITY|||||||0.5574|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5574
71673500|NCT05870371|142865068|OTHER||Mean Difference (Net)|-4.24|||=|0.006|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_physical subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.006
71673501|NCT05870371|142865068|OTHER||Mean Difference (Net)|-2.24|||=|0.001|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the FABQ\_work subscale.|Null Hypothesis: The application of ATM does not affect the perception of the fear and the effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain (secondary hypothesis).||||=0.001
71840056|NCT02723591|143188685|SUPERIORITY|||||||0.815|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.8150
71840057|NCT02723591|143188686|SUPERIORITY|||||||0.5673|||||||Fisher Exact|||P-values obtained from the Exact Test of treatment arm by Banff scoring levels.||||0.5673
71840058|NCT02151981|143188703|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED|95.0|0.23|0.41|||Log Rank||A hazard ratio \<1 favours Osimertinib 80mg|||0.41|0.23|<0.001
71840059|NCT02151981|143188704|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.39|||<|0.001|TWO_SIDED|95.0|3.47|8.48|||Regression, Logistic|adjusted for ethnicity (Asian/non-Asian)|odds ratio \>1.0 favours Osimertinib 80 mg|||8.48|3.47|<0.001
71673502|NCT05870371|142865068|OTHER||Dependence coefficient (β)|0.1|STANDARD_ERROR_OF_MEAN|0.07|=|0.197|TWO_SIDED|||||The above p-value corresponds to the FABQ\_work subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_work subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.197
71677320|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.222|||||TWO_SIDED|95.0|0.813|1.838||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.838|0.813|
71813336|NCT01181726|143129093|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.72|||||TWO_SIDED|90.0|94.03|101.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.56|94.03|
71840060|NCT02151981|143188705|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Expected (DoR)|6.22|||<|0.001|TWO_SIDED|95.0|4.04|9.57|||formulae provided in Ellis S et al 2008|Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients||||9.57|4.04|<0.001
71840061|NCT02151981|143188706|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.76|||<|0.001|TWO_SIDED|95.0|2.64|8.84|||Regression, Logistic||odds ratio \>1.0 favours Osimertinib 80 mg|||8.84|2.64|<0.001
71840062|NCT02151981|143188707|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-21.62|||<|0.001|TWO_SIDED|95.0|-27.71|-15.52|||ANCOVA|Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions|LS Mean: Osimertinib -46.93, Chemo -25.3 A difference in LS means \<0 favours Osimertinib 80mg|||-15.52|-27.71|<0.001
71840063|NCT02151981|143188708|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.277|TWO_SIDED|95.0|0.67|1.13|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.13|0.67|0.277
71840064|NCT02151981|143188709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.16|0.28|||Log Rank||A hazard ratio \<1 favors Osimertinib 80mg|||0.28|0.16|<0.001
71840065|NCT02151981|143188710|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87|||<|0.001|TWO_SIDED|95.0|0.69|1.11|||Log Rank||A hazard ratio \<1 favours Osimertinib 80 mg|||1.11|0.69|<0.001
71840066|NCT04409353|143188761|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.47||||0.4884|TWO_SIDED|95.0|-0.87|1.81||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.81|-0.87|0.4884
71893078|NCT00741819|143307387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_DEVIATION|23.7|<|0.001||95.0|||||Wilcoxon signed-rank test||Global Satisfaction, change from Baseline to Week 12|||||<0.001
71893079|NCT00741819|143307387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.9|STANDARD_DEVIATION|21.5|<|0.001||95.0|||||Wilcoxon signed rank test||Effectiveness score, change from Baseline to Week 12|||||<0.001
71893080|NCT00741819|143307389|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||||||0.001
71673503|NCT05870371|142865068|OTHER||Dependence coefficient (β)|0.07|STANDARD_ERROR_OF_MEAN|0.04|=|0.066|TWO_SIDED|||||The above p-value corresponds to the FABQ\_physical subscale. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the FABQ\_physical subscale. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of perception of fear and effort to avoid pain in relation to physical and work activities assessed by the Fear Avoidance Beliefs Questionnaire\_Greek version (FABQ\_GR) in patients with chronic neck pain from the application of A-S (secondary hypothesis).||||=0.066
71673504|NCT05870371|142865069|OTHER||Mean Difference (Net)|-7.07|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Total PCS score.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673505|NCT05870371|142865069|OTHER||Mean Difference (Net)|-2.02|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Rumination subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71673506|NCT05870371|142865069|OTHER||Mean Difference (Net)|-1.66|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Magnification subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71795549|NCT00136084|143088388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.624||||0.1559||95.0|0.832|3.205||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.|The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.|The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O'Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.||3.205|.832|.1559
71795550|NCT00136084|143088389|SUPERIORITY_OR_OTHER||Binomial proportion|0.733||||||95.0|0.449|0.922|||Binomial proportion|||Estimate of the proportion of negative minimal residual disease.||.922|.449|
71795551|NCT00136084|143088390|SUPERIORITY_OR_OTHER||Binomial proportion|0.931||||||95.0|0.772|0.992|||Binomial proportion|||||.992|.772|
71795552|NCT00136084|143088391|SUPERIORITY_OR_OTHER||Binomial proportion|0.9||||||95.0|0.735|0.979|||Binomial proportion|||||.979|.735|
71795553|NCT00136084|143088393|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
71795554|NCT00136084|143088394|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.0139||||0.2287|TWO_SIDED|95.0|-0.0365|0.00873|||Regression, Logistic|||||0.00873|-0.0365|0.2287
71795555|NCT03244865|143088405|NON_INFERIORITY|Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.|||||<|0.1||||||Pilot Study|t-test, 2 sided|||There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.||||<.1
71840067|NCT04409353|143188761|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 30, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.16||||0.8095|TWO_SIDED|95.0|-1.12|1.43||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The primary analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 7, 15, 21, and 30, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.43|-1.12|0.8095
71795556|NCT01536496|143088436|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||Chi-square test||||0.04
71795557|NCT03249779|143088458|SUPERIORITY|||||||0.0396|||||||t-test, 2 sided|||||||0.0396
71795558|NCT03249779|143088459|SUPERIORITY|||||||0.133|||||||t-test, 2 sided|||||||0.1330
71795559|NCT03314584|143088462|SUPERIORITY||||||<|0|||||||Mixed Models Analysis|F=21.662, df = 1||||||<0.000
71795560|NCT03314584|143088463|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|F=5.624, df=1||||||0.004
71795561|NCT03314584|143088464|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|F=3.092, df=1||||||0.046
71795562|NCT03314584|143088465|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|F=4.022, df=1||||||0.018
71795563|NCT03314584|143088466|SUPERIORITY|||||||0.598|||||||Mixed Models Analysis|F=0.279, df=1||||||0.598
71795564|NCT03314584|143088467|SUPERIORITY|||||||0.296|||||||Mixed Models Analysis|F=1.101, df=1||||||0.296
71795565|NCT03314584|143088468|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|F=4.672, df = 1||||||0.033
71795566|NCT03314584|143088469|SUPERIORITY|||||||0.606|||||||Mixed Models Analysis|F=0.268, df=1||||||0.606
71795567|NCT03314584|143088470|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|F=1.142, df=1||||||0.287
71795568|NCT03314584|143088471|SUPERIORITY|||||||0.049|||||||Mixed Models Analysis|F=4.039, df=1||||||0.049
71795569|NCT03314584|143088472|SUPERIORITY|||||||0.338|||||||Mixed Models Analysis|F=1.084, df=1||||||0.338
71893081|NCT01126580|143307392|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.36|-0.08||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of 1.5 mg LY2189265 vs Metformin on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 2-sided alpha of 0.05 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 11%.||-0.08|-0.36|<0.001
71795570|NCT04302389|143088494|OTHER||||||<|0.001|||||||t-test, 2 sided|||This was a within-subject comparison at two timepoints (baseline, 3 months)||||<0.001
71795571|NCT01928862|143088526|OTHER||Treatment difference|-31.3|||||TWO_SIDED|90.0|-58.8|0.8||||||Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||0.8|-58.8|
71795572|NCT01928862|143088526|OTHER||Treatment Difference|6.3|||||TWO_SIDED|90.0|-25.3|36.9||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||36.9|-25.3|
71795573|NCT01928862|143088526|OTHER||Treatment Difference|-4.5|||||TWO_SIDED|90.0|-33.5|26.3||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.||26.3|-33.5|
71795574|NCT04649164|143088539|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Paired t-tests comparing peer mentors' baseline and 16-week scores, and caregiver mentees' baseline and 16-week scores, respectively||||0.36
71795575|NCT04649164|143088541|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.30
71795576|NCT04649164|143088542|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71795577|NCT04649164|143088543|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71795578|NCT04649164|143088546|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71795579|NCT02053753|143088561|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometrc Means (CP4:CP2)|1.084|||||TWO_SIDED|90.0|0.995|1.181|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.181|0.995|
71795580|NCT02053753|143088562|NON_INFERIORITY_OR_EQUIVALENCE|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometric Means (CP4:CP2)|1.028|||||TWO_SIDED|90.0|0.934|1.131|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.|||1.131|0.934|
71795581|NCT00499096|143088606|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71795582|NCT01067768|143088613|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.5|1.3|||||The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.|The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.||1.3|0.50|
71795583|NCT01067768|143088614|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients||||0.016
71795584|NCT03735667|143088627|NON_INFERIORITY|A Bayesian analysis based on 10,000 samples from the posterior distribution, using a piecewise exponential survival model. The criteria for non-inferiority is met if the posterior probability of non-inferiority is greater than the non-inferiority test threshold.|||||||||||||||||A Bayesian analysis was used to test the non-inferiority hypothesis for the primary endpoint using a non-inferiority margin of 8%. The pre-specified success criteria (the non-inferiority test threshold) was a posterior probability of non-inferiority greater than 97.5%. The observed posterior probability of non-inferiority was 77.9%. The posterior median percentage difference in the rate of the primary outcome was 6.63% (95% Bayesian credible interval: 3.04% to 10.20%).|||
71795585|NCT02767427|143088660|EQUIVALENCE|An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.|||||<|0.05|||||||t-test, 1 sided|Two one-sided t-tests were conducted with 18 in each group.||||||<0.05
71795586|NCT01073865|143088685|NON_INFERIORITY_OR_EQUIVALENCE|The lower limit of the CI of the difference is greater than or equal to -17.5%. This non-inferiority margin was pre-defined in the study protocol.|Risk Difference (RD)|1.29|||||TWO_SIDED|95.0|-11.4|13.9|||||%PFS at 24 weeks for Zoladex 10.8mg - %PFS at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al||13.90|-11.40|
71795587|NCT01073865|143088686|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.02|||||TWO_SIDED|95.0|-15.47|9.67|||||ORR at 24 weeks for Zoladex 10.8mg - ORR at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al||9.67|-15.47|
71795588|NCT04681482|143088749|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.54|0.7|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of MB between cohorts.||0.70|0.54|<0.001
71795589|NCT04681482|143088751|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.088|TWO_SIDED|95.0|0.66|1.03|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of stroke/SE between cohorts.||1.03|0.66|0.088
71795590|NCT04681482|143088753|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.76|||Cox Proportional Hazards Model|||Cox Proportional Hazards Model was used to compare the risk of net clinical benefit between cohorts.||0.76|0.60|<0.001
71795591|NCT03608774|143088762|SUPERIORITY||Risk Difference (RD)|0.26|||<|0.001|TWO_SIDED|95.0|0.16|0.36||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. P-value was derived using stage-wise ordering of the sample space.|Chi-squared||Protocol pre-specified an interim analysis of the primary outcome using O'Brien-Fleming bounds to maintain an overall 5% alpha level. The trial was stopped at the interim analysis. Estimates were derived using stage-wise ordering of the sample space.|||0.36|0.16|<0.001
71795592|NCT03608774|143088763|OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|0.0|0.22||||||||0.22|0.00|
71795593|NCT03608774|143088764|OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.01|0.21||||||||0.21|-0.01|
71795594|NCT03608774|143088765|OTHER||Risk Difference (RD)|0.26|||||TWO_SIDED|95.0|0.15|0.38||||||||0.38|0.15|
71795595|NCT03608774|143088766|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
71795596|NCT03608774|143088767|OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.28|0.7||||||||0.70|-0.28|
71795597|NCT03200899|143088792|SUPERIORITY|||||||0.926|||||||ANCOVA|||||||0.926
71795598|NCT03200899|143088793|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.750
71840068|NCT04409353|143188762|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.79||||0.3101|TWO_SIDED|95.0|-0.74|2.32||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.32|-0.74|0.3101
71840069|NCT04409353|143188762|OTHER|The inference will be based on the treatment comparison of least squares means for Day 60, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.42||||0.6328|TWO_SIDED|95.0|-2.13|1.3||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.30|-2.13|0.6328
71795599|NCT03200899|143088794|SUPERIORITY|||||||0.129|||||||ANCOVA|||||||0.129
71795600|NCT03200899|143088795|SUPERIORITY|||||||0.152|||||||ANCOVA|||||||0.152
71795601|NCT03200899|143088796|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||0.037
71795602|NCT03200899|143088797|SUPERIORITY|||||||0.297|||||||ANCOVA|||||||0.297
71795603|NCT03200899|143088798|SUPERIORITY|||||||0.293|||||||ANCOVA|||||||0.293
71795604|NCT03200899|143088799|SUPERIORITY|||||||0.045|||||||ANCOVA|||||||0.045
71795605|NCT00082433|143088810|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0005||95.0|0.69|0.9|||Log Rank|||The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.||.90|.69|.0005
71795606|NCT00082433|143088811|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.89|||<|0.0001||95.0|1.44|2.5|||Cochran-Mantel-Haenszel|||||2.50|1.44|<.0001
71795607|NCT00082433|143088815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.||||<0.0001
71795608|NCT00082433|143088816|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.1162||95.0|0.78|1.03||The test was stratified by (taxane resistance \[yes/no\], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease \[yes/no\], and anthracycline resistance \[yes/no\]).|Log Rank|The analysis was conducted at the 0.05 level and no adjustments were performed||This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.||1.03|.78|.1162
71795609|NCT00082433|143088816|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.0231||95.0|0.75|0.98|||Regression, Cox|||This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.||.98|.75|.0231
71795610|NCT04477304|143088837|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.12|-0.07||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.07|-0.12|<0.001
71795611|NCT04477304|143088838|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.23|-0.16||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.16|-0.23|<0.001
71795612|NCT04477304|143088839|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.1|-0.06||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.06|-0.10|<0.001
71795613|NCT04477304|143088840|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.01|<|0.001|TWO_SIDED|95.0|-0.08|-0.03||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.03|-0.08|<0.001
71795614|NCT04477304|143088841|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.392|TWO_SIDED|95.0|-0.03|-0.01||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.01|-0.03|0.392
71795615|NCT04477304|143088842|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|-0.13|-0.05||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|Left-Censored Tobit Regression||Assuming a clinic-level intraclass correlation of 0.01, alpha 0.025, 86 clinics, and 5.5 clinicians per-clinic (N = 473), it was calculated we would have over 85% power for a one-tailed test detecting a 12% reduction in MME from baseline to intervention.||-0.05|-0.13|<0.001
71795616|NCT05083442|143088855|SUPERIORITY||Mean Difference (Net)|0.8||||0.19|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||1.9|-0.4|0.19
71795617|NCT05083442|143088856|SUPERIORITY||Mean Difference (Net)|0.3||||0.745|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA||Estimated difference between groups from analysis of covariance with baseline fat mass included as the covariate.|Groups were compared using analysis of covariance with baseline included as the covariate.||2.1|-1.5|0.745
71795618|NCT01344447|143088885|SUPERIORITY_OR_OTHER||Percentage difference|22.3|||<|0.0001|TWO_SIDED|95.1|20.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.4|<0.0001
71795619|NCT01344447|143088885|SUPERIORITY_OR_OTHER||Percentage difference|63.8|||<|0.0001|TWO_SIDED|95.1|60.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||60.9|<0.0001
71795620|NCT01344447|143088885|SUPERIORITY_OR_OTHER||Percentage difference|19.6|||<|0.0001|TWO_SIDED|95.1|17.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||17.8|<0.0001
71795621|NCT01344447|143088885|SUPERIORITY_OR_OTHER||Percentage difference|15.0|||<|0.0001|TWO_SIDED|95.1|13.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.3|<0.0001
71795622|NCT01344447|143088885|SUPERIORITY_OR_OTHER||Percentage difference|18.5|||<|0.0001|TWO_SIDED|95.1|16.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||16.5|<0.0001
71893082|NCT01126580|143307392|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.15|||<|0.001|TWO_SIDED|95.0|-0.29|-0.01||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.01|-0.29|<0.001
71893083|NCT01126580|143307392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.002|TWO_SIDED|95.0|-0.36|-0.08||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.08|-0.36|0.002
71795623|NCT01344447|143088886|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.7|||||TWO_SIDED|95.1|-3.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-3.6|
71795624|NCT01344447|143088886|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-5.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.4|
71795625|NCT01344447|143088886|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||TWO_SIDED|95.1|-4.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-4.7|
71795626|NCT01344447|143088886|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.2|||||TWO_SIDED|95.1|-5.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.9|
71795627|NCT01344447|143088886|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|21.5|||||TWO_SIDED|95.1|14.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.1|
71795628|NCT01344447|143088887|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|8.8|||||TWO_SIDED|95.1|7.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.7|
71840070|NCT04409353|143188762|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.16||||0.126|TWO_SIDED|95.0|-0.33|2.64||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||2.64|-0.33|0.1260
71840071|NCT04409353|143188762|OTHER|The inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.51||||0.515|TWO_SIDED|95.0|-2.05|1.03||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-PI score obtained at Days 60 and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PI t-score as a continuous covariate.||1.03|-2.05|0.5150
71840072|NCT04409353|143188763|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.43||||0.018|TWO_SIDED|95.0|0.25|2.61||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||2.61|0.25|.0180
71840073|NCT04409353|143188763|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.5742|TWO_SIDED|95.0|-1.48|0.82||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PCS SF-6 score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PCS SF-6 t-score as a continuous covariate.||0.82|-1.48|0.5742
71840074|NCT04409353|143188764|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.39||||0.7338|TWO_SIDED|95.0|-1.85|2.62||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- Anxiety score obtained at Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.62|-1.85|0.7338
71893084|NCT01126580|143307392|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.02|TWO_SIDED|95.0|-0.29|-0.01||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.01|-0.29|0.020
71893085|NCT01126580|143307393|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.35|-0.02||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||-0.02|-0.35|<0.001
71893086|NCT01126580|143307393|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.04|||<|0.001|TWO_SIDED|95.0|-0.2|0.12||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||||0.12|-0.20|<0.001
71795629|NCT01344447|143088887|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|30.3|||||TWO_SIDED|95.1|28.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||28.6|
71795630|NCT01344447|143088887|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.1|8.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||8.5|
71795631|NCT01344447|143088887|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|7.6|||||TWO_SIDED|95.1|6.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||6.6|
71795632|NCT01344447|143088887|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.1|||||TWO_SIDED|95.1|7.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.9|
71795633|NCT01344447|143088888|SUPERIORITY_OR_OTHER||percentage|61.7|||||ONE_SIDED|95.1|55.3||||One sided 95.1% confidence interval|||Majority reader|||55.3|
71795634|NCT01344447|143088888|SUPERIORITY_OR_OTHER||percentage|60.3|||||ONE_SIDED|95.1|53.6||||One sided 95.1% confidence interval|||Blinded Reader 1|||53.6|
71795635|NCT01344447|143088888|SUPERIORITY_OR_OTHER||percentage|59.6|||||ONE_SIDED|95.1|53.1||||One sided 95.1% confidence interval|||Blinded Reader 2|||53.1|
71795636|NCT01344447|143088888|SUPERIORITY_OR_OTHER||percentage|58.7|||||ONE_SIDED|95.1|52.2||||One sided 95.1% confidence interval|||Blinded Reader 3|||52.2|
71795637|NCT01344447|143088888|SUPERIORITY_OR_OTHER||percentage|61.5|||||ONE_SIDED|95.1|56.7||||One sided 95.1% confidence interval|||Clinical investigator|||56.7|
71795638|NCT01344447|143088889|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Majority reader|||97.7|
71795639|NCT01344447|143088889|SUPERIORITY_OR_OTHER||percentage|97.6|||||ONE_SIDED|95.1|97.3||||One sided 95.1% confidence interval|||Blinded Reader 1|||97.3|
71795640|NCT01344447|143088889|SUPERIORITY_OR_OTHER||percentage|97.2|||||ONE_SIDED|95.1|96.9||||One sided 95.1% confidence interval|||Blinded Reader 2|||96.9|
71893087|NCT01126580|143307393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.024|TWO_SIDED|95.0|-0.35|-0.02||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||-0.02|-0.35|0.024
71795641|NCT01344447|143088889|SUPERIORITY_OR_OTHER||percentage|98.0|||||ONE_SIDED|95.1|97.7||||One sided 95.1% confidence interval|||Blinded Reader 3|||97.7|
71795642|NCT01344447|143088889|SUPERIORITY_OR_OTHER||percentage|99.2|||||ONE_SIDED|95.1|98.9||||One sided 95.1% confidence interval|||Clinical investigator|||98.9|
71795643|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.21|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
71795644|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.0|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
71795645|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.29|STANDARD_DEVIATION|0.87|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
71795646|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.01|STANDARD_DEVIATION|0.8|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
71795647|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.48|STANDARD_DEVIATION|0.98|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point||||
71795648|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.33|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point||||
71795649|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.02|STANDARD_DEVIATION|0.81|||||||||Mean Difference|||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point||||
71795650|NCT01344447|143088890|SUPERIORITY_OR_OTHER||Diameter difference|0.11|STANDARD_DEVIATION|0.79|||||||||Mean Difference|||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point||||
71795651|NCT01094548|143088921|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
71795652|NCT01094548|143088925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.431||||0.094|TWO_SIDED|95.0|0.157|1.185|||Log Rank|||||1.185|0.157|0.0940
71795653|NCT01094548|143088926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.3919|TWO_SIDED|95.0|0.261|1.698|||Log Rank|||||1.698|0.261|0.3919
71795654|NCT03969992|143088954|SUPERIORITY|||||||0.1924||||||A closed test procedure is used to protect the type I error rate; the order of testing was: AeroFact high dose compared to control and if significant (p-value \<0.05), the AeroFact low dose was compared to the control.|Generalized estimating equation method|||||||0.1924
71795655|NCT02063737|143088961|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3882||||0.083|TWO_SIDED|95.0|-0.8272|0.0508|||Mixed Models Analysis|adjusting for shift length|Adjusted difference between intervention groups (intervention - control) from the linear mixed model adjusting for shift length and repeated measures within individuals.|||0.0508|-0.8272|0.0830
71795656|NCT02063737|143088962|SUPERIORITY_OR_OTHER|||||||0.0114|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0114
71795657|NCT02063737|143088963|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||.99
71795658|NCT02063737|143088964|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||ANCOVA|adjusted for baseline measure||||||0.0927
71795659|NCT02063737|143088965|SUPERIORITY_OR_OTHER|||||||0.0578|TWO_SIDED||||||ANCOVA|adjusting for the baseline measure||||||0.0578
71795660|NCT02063737|143088966|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.69
71795661|NCT02063737|143088967|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.65
71795662|NCT02063737|143088968|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.95
71795663|NCT02063737|143088969|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.21
71795664|NCT02063737|143088970|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.51
71795665|NCT02063737|143088971|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.28
71795666|NCT02063737|143088972|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.0930
71893088|NCT01126580|143307393|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.299|TWO_SIDED|95.0|-0.2|0.12||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.||0.12|-0.20|0.299
71893089|NCT01126580|143307394|SUPERIORITY_OR_OTHER|||||||0.023||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.023
71795667|NCT02063737|143088973|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.56
71795668|NCT02063737|143088974|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANCOVA|adjusting for baseline measure||||||0.20
71795669|NCT03373383|143088986|SUPERIORITY||Percent reduction|17.2|||=|0.102|TWO_SIDED|95.0|-3.8|33.9||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||33.9|-3.8|=0.102
71795670|NCT03373383|143088986|SUPERIORITY||Percent reduction|19.1|||=|0.064|TWO_SIDED|95.0|-1.2|35.4||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.4|-1.2|=0.064
71795671|NCT03373383|143088986|SUPERIORITY||Percent reduction|19.2|||=|0.063|TWO_SIDED|95.0|-1.2|35.5||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp(diff)), where diff was the model estimate of the log ratio between each PSL group and placebo group.||35.5|-1.2|=0.063
71795672|NCT03373383|143088986|SUPERIORITY||Percent reduction|12.4|||=|0.248|TWO_SIDED|95.0|-9.7|30.1||Adjusted p-values were from the Hochberg step-up procedure within SAS® Proc Multtest to control Type I error.|ANCOVA|||Percent reduction over placebo was calculated as 100\*(1-exp\[diff\]), where diff was the model estimate of the log ratio between each PSL group and placebo group.||30.1|-9.7|=0.248
71795673|NCT03373383|143088987|SUPERIORITY||Odds Ratio (OR)|2.72|||=|0.081|TWO_SIDED|95.0|0.88|8.39||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||8.39|0.88|=0.081
71795674|NCT03373383|143088987|SUPERIORITY||Odds Ratio (OR)|2.37|||=|0.137|TWO_SIDED|95.0|0.76|7.41||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||7.41|0.76|=0.137
71795675|NCT03373383|143088987|SUPERIORITY||Odds Ratio (OR)|2.16|||=|0.192|TWO_SIDED|95.0|0.68|6.89||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||6.89|0.68|=0.192
71795676|NCT03373383|143088987|SUPERIORITY||Odds Ratio (OR)|3.14|||=|0.041|TWO_SIDED|95.0|1.05|9.42||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo was calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||9.42|1.05|=0.041
71840075|NCT04409353|143188764|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.63||||0.5279|TWO_SIDED|95.0|-1.34|2.6||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Anxiety score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Anxiety t-score as a continuous covariate.||2.60|-1.34|0.5279
71893090|NCT01126580|143307394|SUPERIORITY_OR_OTHER|||||||0.021||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.021
71893091|NCT01126580|143307394|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||<0.001
71795677|NCT03373383|143088991|SUPERIORITY||Odds Ratio (OR)|2.09|||=|0.045|TWO_SIDED|95.0|1.02|4.3||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||4.30|1.02|=0.045
71795678|NCT03373383|143088991|SUPERIORITY||Odds Ratio (OR)|1.91|||=|0.079|TWO_SIDED|95.0|0.93|3.93||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.93|0.93|=0.079
71795679|NCT03373383|143088991|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.338|TWO_SIDED|95.0|0.68|3.02||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/placebo calculated using logistic regression with categorical factors for treatment group (each PSL dose group referenced to the placebo group), region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.02|0.68|=0.338
71795680|NCT03373383|143088991|SUPERIORITY||Odds Ratio (OR)|1.88|||=|0.087|TWO_SIDED|95.0|0.91|3.87||Nominal p-values were not adjusted for multiplicity.|Regression, Logistic|||PSL dose/Placebo calculated using logistic regression with categorical factors for treatment group, Region (Europe, Non-Europe), Baseline SV2A use (0, 1) and log-transformed Baseline seizure frequency as a continuous covariate.||3.87|0.91|=0.087
71795681|NCT03373383|143088992|OTHER||Median Difference (Net)|7.4|||=|0.316|TWO_SIDED|95.0|-6.59|21.89||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.89|-6.59|=0.316
71893092|NCT01126580|143307394|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.011
71795682|NCT03373383|143088992|OTHER||Median Difference (Net)|9.99|||=|0.133|TWO_SIDED|95.0|-3.15|23.26||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||23.26|-3.15|=0.133
71795683|NCT03373383|143088992|OTHER||Median Difference (Net)|8.19|||=|0.203|TWO_SIDED|95.0|-3.95|21.37||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||21.37|-3.95|=0.203
71795684|NCT03373383|143088992|OTHER||Median Difference (Net)|2.39|||=|0.784|TWO_SIDED|95.0|-13.65|17.79||Nominal p-values were not adjusted for multiplicity.|Wilcoxon (Mann-Whitney)|||Dose group comparisons to Placebo p-value were based on the Wilcoxon-Mann-Whitney test. The Hodges-Lehmann nonparametric estimator was used to estimate the median difference between each PSL dose group versus placebo, along with the corresponding 95% CI of the estimate.||17.79|-13.65|=0.784
71795685|NCT03317431|143088993|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.||||<0.01
71795686|NCT03317431|143088994|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.||||>0.01
71795687|NCT03317431|143088995|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with TH expression.||||>0.01
71795688|NCT03317431|143088996|SUPERIORITY||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DDC expression.||||>0.01
71795689|NCT03317431|143088997|SUPERIORITY||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.||||<0.01
71795690|NCT04753164|143089007|OTHER|Mixed effects model for Repeated Measures: Change from baseline in the number of BE days per week = baseline number of BE days per week + sex (Male; Female) + BMI group (\< 30 ; ≥ 30 kg/m2) + treatment + visit + treatment × visit + baseline × visit.|LS Mean Difference to Placebo|0.0||||0.9992|TWO_SIDED|95.0|-0.69|0.69|||Mixed effects model f. repeated measures|||||0.69|-0.69|0.9992
71795691|NCT00694369|143089008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|"Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value~for 120-mg dose comparison is significant)."||||||<0.001
71795692|NCT00694369|143089008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|ANOVA|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
71795693|NCT00694369|143089008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.06||||||95.0|-1.37|1.48|||||Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)|||1.48|-1.37|
71795694|NCT00694369|143089008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.43||||||95.0|-0.73|1.6|||||Difference in LS Means (etoricoxib minus ibuprofen)|||1.60|-0.73|
71795695|NCT00694369|143089008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.|Difference in LS Means|3.9||||||95.0|2.04|5.76|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.76|2.04|
71795696|NCT00694369|143089008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.|Difference in LS Means|4.27||||||95.0|2.61|5.94|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)|||5.94|2.61|
71795697|NCT00694369|143089008|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.38||||||95.0|-1.8|1.05|||||Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)|||1.05|-1.80|
71795698|NCT00694369|143089008|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|10.59||||||95.0|8.72|12.47|||||Difference in LS Means (ibuprofen 2400 mg minus placebo)|||12.47|8.72|
71795699|NCT00694369|143089008|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.75||||||95.0|4.53|8.97|||||Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)|||8.97|4.53|
71795700|NCT00694369|143089009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).||||||<0.001
71795701|NCT00694369|143089009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)||||||<0.001
71795702|NCT00694369|143089009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.||||||0.161
71795703|NCT00694369|143089009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.014
71795704|NCT00694369|143089009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.||||||0.007
71795705|NCT00314236|143089017|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||ANCOVA|||||||0.011
71795706|NCT00314236|143089018|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||ANCOVA|||||||0.033
71893093|NCT01126580|143307394|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.001
71893094|NCT01126580|143307394|SUPERIORITY_OR_OTHER|||||||0.269||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.269
71893095|NCT01126580|143307394|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||<0.001
71893096|NCT01126580|143307394|SUPERIORITY_OR_OTHER|||||||0.134||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.134
71893097|NCT01126580|143307395|SUPERIORITY_OR_OTHER|||||||0.079||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.079
71795707|NCT02907359|143089066|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6063|TWO_SIDED|95.0|0.74|1.19||OS between Guadecitabine vs Treatment Choice using stratified log-rank test. Due to pre-specified hierarchical testing plan, other endpoints were not evaluated for statistical significance.|Stratified Log-rank test|||||1.19|0.74|0.6063
71840076|NCT04409353|143188765|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.19||||0.1833|TWO_SIDED|95.0|-0.56|2.94||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||2.94|-0.56|0.1833
71893098|NCT01126580|143307395|SUPERIORITY_OR_OTHER|||||||0.451||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.451
71893099|NCT01126580|143307395|SUPERIORITY_OR_OTHER|||||||0.025||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.025
71795708|NCT01405963|143089080|OTHER||Treatment Difference|7.65||||0.09|TWO_SIDED|95.0|-1.3|16.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||16.60|-1.30|0.09
71795709|NCT01405963|143089080|OTHER||Treatment Difference|9.91||||0.02|TWO_SIDED|95.0|1.59|18.23|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||18.23|1.59|0.02
71795710|NCT01405963|143089081|OTHER||Treatment Difference|-4.35||||0.11|TWO_SIDED|95.0|-9.8|1.1|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures analysis of covariance (ANCOVA) that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||1.10|-9.80|0.11
71795711|NCT01405963|143089081|OTHER||Treatment Difference|-4.66||||0.07|TWO_SIDED|95.0|-9.71|0.39|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.39|-9.71|0.07
71795712|NCT01405963|143089085|OTHER||Treatment Difference|8.57||||0.05|TWO_SIDED|95.0|0.01|17.13|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||17.13|0.01|0.05
71795713|NCT01405963|143089085|OTHER||Treatment Difference|10.27||||0.06|TWO_SIDED|95.0|-0.46|21.0|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||21.00|-0.46|0.06
71795714|NCT01405963|143089086|OTHER||Treatment Difference|-6.08||||0.03|TWO_SIDED|95.0|-11.56|-0.6|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.60|-11.56|0.03
71795715|NCT01405963|143089086|OTHER||Treatment Difference|-7.44||||0.03|TWO_SIDED|95.0|-14.22|-0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||-0.66|-14.22|0.03
71893100|NCT01126580|143307395|SUPERIORITY_OR_OTHER|||||||0.402||||||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||||0.402
71893101|NCT01126580|143307396|SUPERIORITY_OR_OTHER|||||||0.061||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.061
71893102|NCT01126580|143307396|SUPERIORITY_OR_OTHER|||||||0.647||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.647
71893103|NCT01126580|143307396|SUPERIORITY_OR_OTHER|||||||0.022||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.022
71840077|NCT04409353|143188765|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.33||||0.7006|TWO_SIDED|95.0|-2.04|1.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Sleep Disturbance score obtained at Days 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Sleep Disturbance t-score as a continuous covariate.||1.37|-2.04|0.7006
71840078|NCT04409353|143188766|OTHER||Common Odds Ratio|0.76||||0.1913|TWO_SIDED|95.0|0.5|1.15||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.15|0.50|0.1913
71840079|NCT04409353|143188766|OTHER||Common Odds Ratio|0.83||||0.367|TWO_SIDED|95.0|0.55|1.24||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and day 90) and response (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||1.24|0.55|0.3670
71840080|NCT04409353|143188767|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.83||||0.1619|TWO_SIDED|95.0|-1.98|0.33||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||0.33|-1.98|0.1619
71893104|NCT01126580|143307396|SUPERIORITY_OR_OTHER|||||||0.469||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.469
71893105|NCT01126580|143307397|SUPERIORITY_OR_OTHER|||||||0.811||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.811
71893106|NCT01126580|143307397|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
71795716|NCT01405963|143089087|OTHER||Treatment Difference|0.33||||0.05|TWO_SIDED|95.0|-0.01|0.68|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.68|-0.01|0.05
71795717|NCT01405963|143089087|OTHER||Treatment Difference|0.39||||0.08|TWO_SIDED|95.0|-0.06|0.84|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.84|-0.06|0.08
71795718|NCT01405963|143089088|OTHER||Treatment Difference|0.28||||0.03|TWO_SIDED|95.0|0.03|0.53|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.53|0.03|0.03
71893107|NCT01126580|143307397|SUPERIORITY_OR_OTHER|||||||0.44||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.440
71893108|NCT01126580|143307397|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
71893109|NCT01126580|143307398|SUPERIORITY_OR_OTHER|||||||0.75||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.750
71893110|NCT01126580|143307398|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA|||||||0.003
71893111|NCT01126580|143307398|SUPERIORITY_OR_OTHER|||||||0.412||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.412
71893112|NCT01126580|143307398|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA|||||||0.001
71893113|NCT01126580|143307399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
71893114|NCT01126580|143307399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis|||||||<0.001
71893115|NCT01126580|143307399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||<0.001
71795719|NCT01405963|143089088|OTHER||Treatment Difference|0.33||||0.06|TWO_SIDED|95.0|-0.01|0.66|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in early asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.66|-0.01|0.06
71795720|NCT01405963|143089089|OTHER||Treatment Difference|0.41||||0.01|TWO_SIDED|95.0|0.12|0.7|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.70|0.12|0.01
71795721|NCT01405963|143089089|OTHER||Treatment Difference|0.42||||0.01|TWO_SIDED|95.0|0.11|0.72|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and Day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.72|0.11|0.01
71795722|NCT01405963|143089090|OTHER||Treatment Difference|0.24||||0.02|TWO_SIDED|95.0|0.04|0.45|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 42 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.45|0.04|0.02
71893116|NCT01126580|143307399|SUPERIORITY_OR_OTHER|||||||0.003||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis|||||||0.003
71893117|NCT01126580|143307399|SUPERIORITY_OR_OTHER|||||||0.001||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.001
71893118|NCT01126580|143307399|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis|||||||0.010
71893119|NCT01126580|143307399|SUPERIORITY_OR_OTHER|||||||0.077||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.077
71893120|NCT01126580|143307399|SUPERIORITY_OR_OTHER|||||||0.004||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis|||||||0.004
71893121|NCT00609622|143307422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.705||||0.9963|TWO_SIDED|95.0|1.272|5.751|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).||5.751|1.272|0.9963
71893122|NCT00609622|143307423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.618||||0.9289|TWO_SIDED|95.0|0.845|3.096|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).||3.096|0.845|0.9289
71893123|NCT00609622|143307426|SUPERIORITY_OR_OTHER||F-Distribution|3.956||||0.5898|TWO_SIDED|95.0|-10.412|18.324|||Chi-squared|||||18.324|-10.412|0.5898
71893124|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.0515|TWO_SIDED|95.0|-2.82|0.01|||t-test, 2 sided|||Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.82|0.0515
71893125|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.45||||0.0876|TWO_SIDED|95.0|-3.11|0.22|||t-test, 2 sided|||Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.22|-3.11|0.0876
71893126|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.81||||0.0522|TWO_SIDED|95.0|-3.64|0.02|||t-test, 2 sided|||Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.02|-3.64|0.0522
71893127|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.64||||0.1339|TWO_SIDED|95.0|-3.81|0.52|||t-test, 2 sided|||Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.52|-3.81|0.1339
71893128|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05||||0.4233|TWO_SIDED|95.0|-3.68|1.57|||t-test, 2 sided|||Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||1.57|-3.68|0.4233
71893129|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.97||||0.2211|TWO_SIDED|95.0|-5.18|1.24|||t-test, 2 sided|||Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.24|-5.18|0.2211
71893130|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41||||0.8184|TWO_SIDED|95.0|-3.22|4.04|||t-test, 2 sided|||Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||4.04|-3.22|0.8184
71893131|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.9||||0.038|TWO_SIDED|95.0|0.57|17.23|||t-test, 2 sided|||Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||17.23|0.57|0.0380
71893132|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6||||0.3266|TWO_SIDED|95.0|-6.61|17.81|||t-test, 2 sided|||Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||17.81|-6.61|0.3266
71673507|NCT05870371|142865069|OTHER||Mean Difference (Net)|-3.39|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Helplessness subscale of PCS.|Null Hypothesis: The application of ATM does not affect the degree of pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71758467|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.77|||<|0.0001|TWO_SIDED|95.0|0.62|0.92|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.92|0.62|<0.0001
71840081|NCT04409353|143188767|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.04||||0.9569|TWO_SIDED|95.0|-1.31|1.24||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS- PF score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-PF t-score as a continuous covariate.||1.24|-1.31|0.9569
71893133|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.75||||0.4667|TWO_SIDED|95.0|-16.26|27.76|||t-test, 2 sided|||Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||27.76|-16.26|0.4667
71893134|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71758468|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.46|0.78|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.78|0.46|<0.0001
71758469|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.97|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.97|0.66|<0.0001
71758470|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.81|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.81|0.49|<0.0001
71758471|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.83|||<|0.0001|TWO_SIDED|95.0|0.66|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.66|<0.0001
71758472|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.46|0.8|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.80|0.46|<0.0001
71758473|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.72|||<|0.0001|TWO_SIDED|95.0|0.54|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.54|<0.0001
71758474|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.3|0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.65|0.30|<0.0001
71758475|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.68|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.49|<0.0001
71673508|NCT05870371|142865069|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.871|TWO_SIDED|||||The above p-value corresponds to the Total PCS score. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Total PCS score. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).|The above values correspond to the comparison which is between groups at baseline.|||=0.871
71673509|NCT05870371|142865069|OTHER||Dependence coefficient (β)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|=|0.887|TWO_SIDED|||||The above p-value corresponds to the Rumination subscale of PCS. The above value correspond to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Rumination subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.887
71673510|NCT05870371|142865069|OTHER||Dependence coefficient (β)|0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.879|TWO_SIDED|||||The above p-value corresponds to the Magnification subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Magnification subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.879
71673511|NCT05870371|142865069|OTHER||Dependence coefficient (β)|0.0|STANDARD_ERROR_OF_MEAN|0.05|=|0.961|TWO_SIDED|||||The above p-value corresponds to the Helplessness subscale of PCS. The above value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Helplessness subscale of PCS. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ from the application of A-S in reducing pain catastrophizing recorded by the Pain Catastrophizing Scale (PCS) in patients with chronic neck pain (secondary hypothesis).||||=0.961
71673512|NCT05870371|142865070|OTHER||Mean Difference (Net)|4.99|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Physical Component Summary/PCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71795723|NCT01405963|143089090|OTHER||Treatment Difference|0.18||||0.15|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Model includes treatment, visit, treatment by visit interaction as fixed effects and day -14 value as covariate.|Treatment difference estimate (tezepelumab minus placebo) is mean estimate based on ANCOVA.|Treatment difference in late asthmatic response at day 84 was evaluated using a repeated-measures ANCOVA that included study treatment and study visit as independent variables, treatment by study visit as an interaction term, and the corresponding baseline value (as measured 14 days before the first dose of a study drug) as a model covariate.||0.44|-0.07|0.15
71795724|NCT04654117|143089125|SUPERIORITY|Multilevel model predicting the effect of the overall consultation model on manual adherence, averaged across clinicians.|unstandardized beta|0.33|STANDARD_ERROR_OF_MEAN|3.85|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
71840082|NCT04409353|143188768|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.03||||0.9727|TWO_SIDED|95.0|-1.8|1.86||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||1.86|-1.80|0.9727
71893135|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.5587|TWO_SIDED|95.0|-2.8|1.52|||t-test, 2 sided|||Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.52|-2.80|0.5587
71893136|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.6122|TWO_SIDED|95.0|-1.37|0.81|||t-test, 2 sided|||Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.81|-1.37|0.6122
71893137|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.4642|TWO_SIDED|95.0|-1.87|0.86|||t-test, 2 sided|||Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.86|-1.87|0.4642
71893138|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.2105|TWO_SIDED|95.0|-2.41|0.54|||t-test, 2 sided|||Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.54|-2.41|0.2105
71795725|NCT04654117|143089126|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
71795726|NCT04654117|143089127|OTHER|multilevel modeling|multilevel modeling|2.56|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||multilevel modeling|||||||<.05
71795727|NCT04654117|143089128|SUPERIORITY||ANOVA|17.0|||<|0.05|TWO_SIDED||||||ANOVA|||||||<.05
71795728|NCT04654117|143089129|OTHER|multilevel model|multilevel model|0.04|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
71673513|NCT05870371|142865070|OTHER||Mean Difference (Net)|8.33|||<|0.001|TWO_SIDED|||||The above p-value corresponds to the Mental Component Summary/MCS subscale of SF-12. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above value corresponds to the Mental Component Summary/MCS subscale of SF-12.|Null Hypothesis: The application of ATM does not affect the quality of life as measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic neck pain (secondary hypothesis).||||<0.001
71795729|NCT04654117|143089130|OTHER|multilevel model|multilevel model (beta)|-0.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||multilevel model|||||||<.05
71795730|NCT00680901|143089132|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3492|TWO_SIDED|95.0|0.73|1.12||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (PE population)||1.12|0.73|0.3492
71795731|NCT00680901|143089133|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.3244|TWO_SIDED|95.0|0.74|1.1||Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Log Rank||Pike estimator of HR was based on the stratified log rank test.|Primary Analysis: OS (ITT population)||1.10|0.74|0.3244
71795732|NCT04544293|143089149|SUPERIORITY||Mean Difference (Net)|6.0||||0.0007|TWO_SIDED|95.0|2.5|9.4|||Mixed Models Analysis|Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Difference from placebo|||9.4|2.5|0.0007
71795733|NCT04544293|143089150|SUPERIORITY||Mean Difference (Net)|6.9||||0.0008|TWO_SIDED|95.0|2.9|10.9||Modelled using MMRM adjusted for baseline % predicted DLCOadj, treatment, visit, region, severity stratification and treatment-visit interaction.|Mixed Models Analysis||Difference from Placebo|||10.9|2.9|0.0008
71795734|NCT04544293|143089151|SUPERIORITY||Mean Difference (Net)|-6.59||||0.0072|TWO_SIDED|95.0|-11.4|-1.79|||Mixed Models Analysis|||||-1.79|-11.40|0.0072
71795735|NCT04544293|143089152|SUPERIORITY||Mean Difference (Net)|-7.81||||0.0149|TWO_SIDED|95.0|-14.1|-1.52|||Mixed Models Analysis|||||-1.52|-14.10|0.0149
71795736|NCT04544293|143089153|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0845|TWO_SIDED|95.0|-0.06|0.89|||Mixed Models Analysis|||||0.89|-0.06|0.0845
71795737|NCT04544293|143089154|SUPERIORITY||Mean Difference (Net)|-4.87||||0.1046|TWO_SIDED|95.0|-10.76|1.01|||Mixed Models Analysis|||||1.01|-10.76|0.1046
71795738|NCT04544293|143089155|SUPERIORITY||Mean Difference (Net)|-5.99||||0.1216|TWO_SIDED|95.0|-13.57|1.59|||Mixed Models Analysis|||||1.59|-13.57|0.1216
71840083|NCT04409353|143188768|OTHER|Primary inference will be based on the treatment comparison of least squares means for Day 90, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the primary endpoint between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|0.43||||0.6427|TWO_SIDED|95.0|-1.4|2.26||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline PROMIS-Depression score obtained for Day 15, 30, 60, and 90, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline PROMIS-Depression t-score as a continuous covariate.||2.26|-1.40|0.6427
71795739|NCT04544293|143089156|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.0234|TWO_SIDED|95.0|0.07|1.03|||Mixed Models Analysis||Change from baseline compared to placebo.|||1.03|0.07|0.0234
71795740|NCT04544293|143089157|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.1043|TWO_SIDED|95.0|-8.84|0.83|||Mixed Models Analysis|||||0.83|-8.84|0.1043
71795741|NCT01951157|143089163|SUPERIORITY||The exact binomial estimator|29.2|||||TWO_SIDED|95.0|13.2|48.4||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.||48.4|13.2|
71795742|NCT01951157|143089163|SUPERIORITY||The exact binomial estimator|19.0|||||TWO_SIDED|95.0|5.7|37.9||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||37.9|5.7|
71795743|NCT01951157|143089163|SUPERIORITY||The exact binomial estimator|28.0|||||TWO_SIDED|95.0|12.6|46.7||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed||46.7|12.6|
71795744|NCT01951157|143089164|SUPERIORITY|Pre-specified|||||=|0.3873|||||||Log Rank|||||||= 0.3873
71795745|NCT01951157|143089168|SUPERIORITY|Pre-specified|||||=|0.0177|||||||Log Rank|||||||= 0.0177
71795746|NCT01951157|143089169|SUPERIORITY_OR_OTHER_LEGACY|Pre-specified||||||0.3526|||||||Log Rank|||||||0.3526
71795747|NCT01951157|143089170|SUPERIORITY|Pre-specified||||||0.9026|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9026
71795748|NCT01951157|143089170|SUPERIORITY|||||||0.9862|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.||||0.9862
71795749|NCT01951157|143089170|SUPERIORITY|||||||0.8057|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.||||0.8057
71795750|NCT04809220|143089171|SUPERIORITY||LS Mean Difference|-0.29|||<|0.001|TWO_SIDED|95.0|-0.43|-0.14|||Mixed Models Analysis|||||-0.14|-0.43|<.001
71795751|NCT04809220|143089172|SUPERIORITY||LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.47|-0.15|||Mixed Models Analysis|||||-0.15|-0.47|<.001
71795752|NCT04809220|143089173|SUPERIORITY||Odds Ratio (OR)|1.15||||0.56|TWO_SIDED|95.0|0.71|1.87|||Generalized Linear Mixed Model (GLM)|||For HbA1c ≤6.5%||1.87|0.71|0.560
71795753|NCT04809220|143089173|SUPERIORITY||Odds Ratio (OR)|1.61||||0.028|TWO_SIDED|95.0|1.05|2.45|||Generalized Linear Mixed Model (GLM)|||For HbA1c \< 7%||2.45|1.05|0.028
71795754|NCT04809220|143089174|SUPERIORITY||LS Mean Difference|-9.4|||<|0.001|TWO_SIDED|95.0|-14.4|-4.3|||Mixed Models Analysis|||||-4.3|-14.4|<.001
71795755|NCT04809220|143089175|SUPERIORITY||LS Mean Difference|-7.2||||0.002|TWO_SIDED|95.0|-11.7|-2.7|||ANCOVA|||Morning premeal-fasting||-2.7|-11.7|0.002
71795756|NCT04809220|143089175|SUPERIORITY||LS Mean Difference|-10.1||||0.016|TWO_SIDED|95.0|-18.3|-1.9|||ANCOVA|||Morning 2-hour post meal||-1.9|-18.3|0.016
71673514|NCT05870371|142865070|OTHER||Dependence coefficient (β)|-0.76|STANDARD_ERROR_OF_MEAN|1.32|=|0.564|TWO_SIDED|||||The above p-value corresponds to the Physical Component Summary/PCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline. The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Physical Component Summary/PCS subscale of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.564
71673515|NCT05870371|142865070|OTHER||Dependence coefficient (β)|-3.05|STANDARD_ERROR_OF_MEAN|1.34|=|0.023|TWO_SIDED|||||The above p-value corresponds to Mental Component Summary/MCS of SF-12. The above p-value corresponds to the comparison which is between groups at baseline.The threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|The Log transformation was used for the mixed linear models.|The above values correspond to the Mental Component Summary/MCS of SF-12. The above values correspond to the comparison which is between groups at baseline.|Null Hypothesis: The effect of the application of ATM does not differ in the improvement of quality of life measured by the Short Form 12-item Health Survey (SF-12) in patients with chronic pain in the cervical spine from the application of A-S (secondary hypothesis).||||=0.023
71795757|NCT04809220|143089175|SUPERIORITY||LS Mean Difference|-8.3||||0.007|TWO_SIDED|95.0|-14.2|-2.3|||ANCOVA|||Midday premeal||-2.3|-14.2|0.007
71795758|NCT04809220|143089175|SUPERIORITY||LS Mean Difference|-12.5||||0.002|TWO_SIDED|95.0|-20.5|-4.5|||ANCOVA|||Midday 2-hour post meal||-4.5|-20.5|0.002
71795759|NCT04809220|143089175|SUPERIORITY||LS Mean Difference|-3.9||||0.158|TWO_SIDED|95.0|-9.3|1.5|||ANCOVA|||Evening premeal||1.5|-9.3|0.158
71795760|NCT04809220|143089175|SUPERIORITY||LS Mean Difference|-11.3||||0.004|TWO_SIDED|95.0|-19.0|-3.7|||ANCOVA|||Evening 2-hour post meal||-3.7|-19.0|0.004
71795761|NCT04809220|143089176|SUPERIORITY||LS Mean Difference|-0.3||||0.213|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||||0.2|-0.8|0.213
71795762|NCT05218018|143089177|OTHER|||||||0.002|||||||t-test, 2 sided|||||||.002
71795763|NCT00329407|143089188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.58|-3.14|||Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This was a within subject analysis. The null hypothesis was that there would be no significant difference in least squares means values obtained for the baseline and week 10 assessment weeks.||-3.14|-6.58|<0.0001
71795764|NCT00329407|143089189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|STANDARD_ERROR_OF_MEAN|2.7||0.001|ONE_SIDED|95.0||||There would a significant reduction in COWAT scores between baseline and Week 10.|Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This is a within subject comparison of COWAT scores botained for the baseline session and the Week 10 session. The null hypothesis is that there would be no difference between these scores.||||0.001
71795765|NCT00978068|143089190|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.59||||0.04|TWO_SIDED|95.0|0.36|0.97|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||0.97|0.36|0.04
71795766|NCT00978068|143089191|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cox Proportional-Hazards|||||||0.13
71795767|NCT00978068|143089192|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8||||0.87|TWO_SIDED|95.0|0.06|11.16|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.||11.16|0.06|0.87
71795768|NCT00978068|143089193|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.14|TWO_SIDED|95.0|0.45|1.12|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||1.12|0.45|0.14
71795769|NCT00978068|143089194|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.004|TWO_SIDED|95.0|0.14|0.68|||Cox Proportional-Hazards|Adjustment for repeated measures in same participant.|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.|||0.68|0.14|0.004
71893139|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.195|TWO_SIDED|95.0|-0.57|2.76|||t-test, 2 sided|||Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||2.76|-0.57|0.1950
71795770|NCT00978068|143089195|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.004|TWO_SIDED|95.0|0.22|0.76|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient.|Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.|||0.76|0.22|0.004
71795771|NCT02120794|143089203|NON_INFERIORITY|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.26|||||TWO_SIDED|95.0|0.125|0.395||||||||0.395|0.125|
71795772|NCT01667978|143089223|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71795773|NCT01324349|143089248|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||<|0.0001|||||||Log Rank||Median difference equals control median minus Hemostatic Patch median in minutes.|The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.||||<0.0001
71893140|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.5779|TWO_SIDED|95.0|-1.55|2.75|||t-test, 2 sided|||Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.75|-1.55|0.5779
71893141|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.6314|TWO_SIDED|95.0|-2.15|3.5|||t-test, 2 sided|||Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.50|-2.15|0.6314
71893142|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.7554|TWO_SIDED|95.0|-2.85|3.87|||t-test, 2 sided|||Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||3.87|-2.85|0.7554
71893143|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.94||||0.3781|TWO_SIDED|95.0|-13.22|5.34|||t-test, 2 sided|||Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||5.34|-13.22|0.3781
71893144|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.85||||0.5715|TWO_SIDED|95.0|-13.83|8.13|||t-test, 2 sided|||Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||8.13|-13.83|0.5715
71795774|NCT01324349|143089249|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.2||||0.0339|TWO_SIDED|95.0|1.9|47.3|||Suissa and Shuster test||Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.|The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.||47.3|1.9|0.0339
71813337|NCT01181726|143129094|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.99|||||TWO_SIDED|90.0|94.11|102.02|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.02|94.11|
71673516|NCT05870371|142865071|OTHER||||||=|0.014||||||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||=0.014
71673517|NCT05870371|142865071|OTHER||Median Difference (Net)|1.0|||||TWO_SIDED|||||||||||||
71813338|NCT01264380|143129095|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|4.64|||||TWO_SIDED|90.0|2.83|7.6||||||The point estimate and 90 percent (%) confidence interval (CI) of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||7.60|2.83|
71813339|NCT01264380|143129096|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|5.05|||||TWO_SIDED|90.0|2.99|8.55||||||The point estimate and 90% CI of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||8.55|2.99|
71813340|NCT01264380|143129097|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|2.45|||||TWO_SIDED|90.0|1.81|3.32||||||The point estimate and 90% CI of vemurafenib plasma Cmax geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.||3.32|1.81|
71813341|NCT01147822|143129104|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0184|||||TWO_SIDED|95.0|0.7658|1.3542|||||The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.|||1.3542|0.7658|
71813342|NCT01147822|143129105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.604|TWO_SIDED|95.0|0.808|1.441|||Log Rank||Hazard ratios were estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with this treatment compared with Sunitinib.|||1.441|0.808|0.604
71813343|NCT04074590|143129183|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.314|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate is better than placebo: Prob (diff\>0)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.314
71813344|NCT04074590|143129183|OTHER|A Bayesian analysis of clinical remission rate (based on total Mayo score) with binomial distribution, was modelled with baseline total Mayo score and treatment group as explanatory variables, to compare the remission rates between LYS006 and placebo groups.|Posterior estimate treatment difference|-3.29||||0.037|TWO_SIDED|90.0|-18.02|13.23||Posterior probability that clinical remission rate \>15% over placebo: Prob (diff\>0.15)|Bayesian analysis||90% credible intervals are reported on the treatment difference|||13.23|-18.02|0.037
71813345|NCT02709005|143129185|SUPERIORITY||Risk Difference (RD)|-0.08||||0.42|TWO_SIDED|95.0|-0.26|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction. The statistical informational goal for the study of 90 participants eligible in the modified Intent-to-Treat (mITT) efficacy population was an ad-hoc sample size determined by logistical considerations, as there was insufficient pilot data upon which to base more formal sample size calculations.||0.08|-0.26|0.420
71813346|NCT02709005|143129186|SUPERIORITY||Risk Difference (RD)|0.14||||0.2|TWO_SIDED|95.0|-0.06|0.33||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants Experiencing Solicited Events between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with solicited urogenital AEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.33|-0.06|0.200
71813347|NCT02709005|143129187|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|||||No SAEs were reported; therefore the Fisher's Exact Test was not performed.||||The null hypothesis was that there was no difference in participants with related SAEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||||
71795775|NCT01324349|143089250|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.5||||0.5029|||||||Fisher Exact||Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.|The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.||||0.5029
71795776|NCT02531321|143089258|OTHER|Unpaired t test with Welch's correction|||||<|0.05|||||||t-test, 2 sided|||||||<.05
71795777|NCT02013167|143089262|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.012|TWO_SIDED|95.0|0.55|0.93|||Stratified Log Rank|Stratified by age (\< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.|||0.93|0.55|0.012
71795778|NCT02013167|143089263|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|9.6|26.2|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||26.2|9.6|< 0.001
71795779|NCT02013167|143089264|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|19.3|||<|0.001|TWO_SIDED|95.0|9.9|28.7|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (\< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).||||28.7|9.9|< 0.001
71795780|NCT02013167|143089265|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.43|0.71|||||The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.|||0.71|0.43|
71795781|NCT04646499|143089285|SUPERIORITY|||||||0.34|||||||Sign test|||||||0.34
71840084|NCT04409353|143188769|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|691.58||||0.291|TWO_SIDED|95.0|-602.98|1986.14||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1986.14|-602.98|0.2910
71840085|NCT04409353|143188769|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly steps between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|405.68||||0.4842|TWO_SIDED|95.0|-741.79|1553.15||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly steps obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline average weekly steps as a continuous covariate.||1553.15|-741.79|0.4842
71840086|NCT04409353|143188770|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|1.0||||0.4228|TWO_SIDED|95.0|-1.48|3.49||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Distraction-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||3.49|-1.48|0.4228
71893145|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.58||||0.1271|TWO_SIDED|95.0|-19.08|3.93|||t-test, 2 sided|||Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||3.93|-19.08|0.1271
71893146|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71795782|NCT04646499|143089286|SUPERIORITY|||||||0.024|||||||Sign test|||||||0.024
71795783|NCT04646499|143089287|SUPERIORITY|||||||0.083|||||||Sign test|||||||0.083
71795784|NCT04646499|143089288|SUPERIORITY|||||||0.049|||||||Sign test|||||||0.049
71795785|NCT04646499|143089289|SUPERIORITY|||||||0.31|||||||Sign test|||||||0.31
71795786|NCT02818218|143089356|SUPERIORITY||correlation coefficient|0.0005||||0.944|TWO_SIDED|98.3|-0.161|0.17|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.170|-0.161|0.944
71795787|NCT02818218|143089357|SUPERIORITY||correlation coefficient|0.27|||<|0.001|TWO_SIDED|98.3|0.11|0.42|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.42|0.11|<0.001
71795788|NCT02818218|143089358|SUPERIORITY||correlation coefficient|0.34|||<|0.001|TWO_SIDED|98.3|0.19|0.48|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CVP. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CVP, and vice versa|||0.48|0.19|<0.001
71673518|NCT05870371|142865071|OTHER||Median Difference (Net)|2.0|||||TWO_SIDED|||||||||||||
71673519|NCT00708461|142865080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.125|STANDARD_ERROR_OF_MEAN|0.1202||0.36|TWO_SIDED|95.0|-0.21|0.46||Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.|ANCOVA|Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.||"The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:~* Intraclass correlation (ICC) of 0.016, estimated from an earlier study~* Variance of 118 kg, estimated from an earlier study~* Cohort N=400~* 15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20."||0.46|-0.21|0.36
71673520|NCT03517540|142865097|SUPERIORITY||Odds Ratio (OR)|0.8||||0.688|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.688
71673521|NCT03517540|142865097|SUPERIORITY||Odds Ratio (OR)|1.01||||0.985|TWO_SIDED|95.0|0.51|1.99|||Cochran-Mantel-Haenszel|||||1.99|0.51|0.985
71673522|NCT03517540|142865097|SUPERIORITY||Odds Ratio (OR)|0.92||||0.87|TWO_SIDED|95.0|0.3|2.84|||Cochran-Mantel-Haenszel|||||2.84|0.3|0.870
71673523|NCT03517540|142865097|SUPERIORITY||Odds Ratio (OR)|1.21||||0.71|TWO_SIDED|95.0|0.41|3.61|||Cochran-Mantel-Haenszel|||||3.61|0.41|0.710
71673524|NCT03517540|142865098|SUPERIORITY||Odds Ratio (OR)|0.37||||0.136|TWO_SIDED|95.0|0.08|1.61|||Cochran-Mantel-Haenszel|||||1.61|0.08|0.136
71673525|NCT03517540|142865098|SUPERIORITY||Odds Ratio (OR)|0.83||||0.747|TWO_SIDED|95.0|0.24|2.9|||Cochran-Mantel-Haenszel|||||2.9|0.24|0.747
71673526|NCT03517540|142865098|SUPERIORITY||Odds Ratio (OR)|0.84||||0.784|TWO_SIDED|95.0|0.18|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.18|0.784
71673527|NCT03517540|142865098|SUPERIORITY||Odds Ratio (OR)|1.45||||0.521|TWO_SIDED|95.0|0.4|5.69|||Cochran-Mantel-Haenszel|||||5.69|0.4|0.521
71673528|NCT03055338|142865111|SUPERIORITY||Difference in LSM|2.6||||0.44|TWO_SIDED|95.0|-4.0|9.2|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Risperidone|||9.2|-4.0|0.440
71795789|NCT02818218|143089360|SUPERIORITY||correlation coefficient|0.07||||0.298|TWO_SIDED|98.3|-0.1|0.24|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.24|-0.10|0.298
71840087|NCT04409353|143188770|OTHER|The inference will be based on the treatment comparison of least squares means for week 12, and a p-value will be presented for this time period only. The null hypothesis is that the mean difference in the change in the average weekly sleep scores between the treatment groups and the sham control group is zero, versus the alternative hypothesis that these differences are not zero.|Difference in Least Squares Means|-0.28||||0.8363|TWO_SIDED|95.0|-2.92|2.37||A two-sided test performed at the 0.05 level of significance.|Mixed Models Analysis||Skills-Based VR - Sham VR|The analysis will compare the treatment groups, separately, to the control group using a linear mixed model repeated measures (MMRM) analysis. The repeated measures are the change from baseline average weekly sleep scores obtained at weeks 1 thorough 12, respectively. The model will include fixed categorical effects for treatment, week, treatment by week interaction, and the baseline sleep score as a continuous covariate.||2.37|-2.92|0.8363
71893147|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.6785|TWO_SIDED|95.0|-1.03|1.58|||t-test, 2 sided|||Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.58|-1.03|0.6785
71893148|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.4623|TWO_SIDED|95.0|-1.63|0.74|||t-test, 2 sided|||Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.74|-1.63|0.4623
71673529|NCT03055338|142865111|SUPERIORITY||Difference in LSM|-4.7||||0.074|TWO_SIDED|95.0|-9.8|0.5|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Placebo|||0.5|-9.8|0.074
71673530|NCT03055338|142865111|SUPERIORITY||Difference in LSM|-7.3||||0.033|TWO_SIDED|95.0|-14.0|-0.6|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = Risperidone - Placebo|||-0.6|-14.0|0.033
71673531|NCT03055338|142865112|OTHER||Difference in % versus Placebo|17.2|||||TWO_SIDED|95.0|3.0|30.8|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|30.8|3.0|
71673532|NCT03055338|142865113|OTHER||Difference in % versus Placebo|-1.2|||||TWO_SIDED|95.0|-9.6|7.0|||||Difference in % = MK-8918 - Placebo||Based on Miettinen \& Nurminen method.|7.0|-9.6|
71673533|NCT03055338|142865114|OTHER||Difference in LSM|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Difference in LSM = MK-8189 - Risperidone|||0.6|-0.2|
71673534|NCT03055338|142865114|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|95.0|-0.5|0.2|||||Difference in LSM = MK-8189 - Placebo|||0.2|-0.5|
71673535|NCT03055338|142865114|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|95.0|-0.8|0.1|||||Difference in LSM = Risperidone - Placebo|||0.1|-0.8|
71673536|NCT02151851|142865119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.899|||<|0.001|TWO_SIDED|95.0|2.382|6.382||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||6.382|2.382|<0.001
71673537|NCT02151851|142865120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.641|||<|0.001|TWO_SIDED|95.0|3.57|16.352||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||16.352|3.570|<0.001
71673538|NCT02151851|142865121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.248|||<|0.001|TWO_SIDED|95.0|2.209|23.786||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic|||||23.786|2.209|<0.001
71795790|NCT02818218|143089361|SUPERIORITY||correlation coefficient|0.22||||0.002|TWO_SIDED|98.3|0.05|0.37|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.37|0.05|0.002
71893149|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.9302|TWO_SIDED|95.0|-1.31|1.2|||t-test, 2 sided|||Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.20|-1.31|0.9302
71893150|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.7502|TWO_SIDED|95.0|-1.84|1.33|||t-test, 2 sided|||Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.33|-1.84|0.7502
71893151|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.9335|TWO_SIDED|95.0|-2.12|1.95|||t-test, 2 sided|||Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.95|-2.12|0.9335
71893152|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.9191|TWO_SIDED|95.0|-2.4|2.17|||t-test, 2 sided|||Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.17|-2.40|0.9191
71795791|NCT02818218|143089362|SUPERIORITY||correlation coefficient|0.33|||<|0.001|TWO_SIDED|98.3|0.17|0.47|||Repeated measures correlation (rmcorr)||The repeated measures correlation coefficient (r\_rm) was calculated to assess the association between SVC and CI. It ranges from -1 to +1, with values closer to +1 indicating that increases in SVC are associated with increases in CI, and vice versa|||0.47|0.17|<0.001
71795792|NCT03722017|143089366|SUPERIORITY||Risk Ratio (RR)|0.91||||0.006|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.006
71893153|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.675|TWO_SIDED|95.0|-3.46|2.27|||t-test, 2 sided|||Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||2.27|-3.46|0.6750
71893154|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.5874|TWO_SIDED|95.0|-4.2|2.43|||t-test, 2 sided|||Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.43|-4.20|0.5874
71893155|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27||||0.4507|TWO_SIDED|95.0|-7.53|16.06|||t-test, 2 sided|||Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||16.06|-7.53|0.4507
71893156|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9||||0.3087|TWO_SIDED|95.0|-4.28|12.08|||t-test, 2 sided|||Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||12.08|-4.28|0.3087
71893157|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.9635|TWO_SIDED|95.0|-16.26|15.76|||t-test, 2 sided|||Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||15.76|-16.26|0.9635
71893158|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71795793|NCT03722017|143089366|SUPERIORITY||Risk Ratio (RR)|0.93||||0.11|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.110
71795794|NCT03722017|143089366|SUPERIORITY||Risk Ratio (RR)|0.92||||0.06|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow-Up Timepoint||||0.060
71795795|NCT03722017|143089367|SUPERIORITY||Mean Difference (Net)|-0.049||||0.738|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 1 applies to the Hospital Discharge Timepoint||||0.738
71795796|NCT03722017|143089367|SUPERIORITY||Mean Difference (Net)|0.001||||0.995|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 2 applies to the SNF Discharge Timepoint||||0.995
71795797|NCT03722017|143089367|SUPERIORITY||Mean Difference (Net)|0.058||||0.721|TWO_SIDED|95.0|||||Mixed Models Analysis|||Statistical Analysis 3 applies to the 90 Day Follow Up Timepoint||||0.721
71795798|NCT03711162|143089370|SUPERIORITY||Least square (LS) mean difference|22.7|STANDARD_ERROR_OF_MEAN|38.12||0.5525|TWO_SIDED|95.0|-52.3|97.6||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from the mixed model.||||97.6|-52.3|0.5525
71795799|NCT03711162|143089370|SUPERIORITY||LS mean difference|-26.7|STANDARD_ERROR_OF_MEAN|37.53||0.4776|TWO_SIDED|95.0|-100.5|47.1||P-value: based on random coefficient regression model (linear slope model) on FVC values.|Coefficient Regression Model|Treatment effect was determined by using estimated slopes for each treatment group on basis of time-by-treatment interaction term from mixed model.||||47.1|-100.5|0.4776
71795800|NCT03711162|143089371|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9648|TWO_SIDED|95.0|0.56|1.74|||Regression, Logistic|||||1.74|0.56|0.9648
71795801|NCT03711162|143089371|SUPERIORITY||Odds Ratio (OR)|1.05||||0.853|TWO_SIDED|95.0|0.6|1.84|||Regression, Logistic|||||1.84|0.60|0.8530
71795802|NCT03711162|143089372|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.5|2.05|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||2.05|0.50|
71795803|NCT03711162|143089372|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.47|1.88|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards for time to respiratory-related hospitalization.|||1.88|0.47|
71795804|NCT03711162|143089373|SUPERIORITY||LS mean difference|-0.5||||0.785|TWO_SIDED|95.0|-4.4|3.3|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||3.3|-4.4|0.7850
71673539|NCT01256164|142865136|NON_INFERIORITY_OR_EQUIVALENCE|With 90 subjects, randomized on a 2:1 ratio into the Fibrocaps plus gelatin sponge active arm or the gelatin sponge arm, and assuming a mean TTH of 3.5 minutes with a standard deviation of 2.5 minutes in the active arm and a mean TTH of 6 minutes in the control arm, this translates in a power of 99.4% at a two-sided significance level alpha of 5%, using a two-sample t-test.|||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71673540|NCT01256164|142865137|SUPERIORITY_OR_OTHER|||||||1||95.0|||||t-test, 2 sided|||||||1.00
71673541|NCT01256164|142865138|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Intent-to-treat analysis||||<0.001
71673542|NCT01256164|142865139|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||intent-to- treat analysis||||0.001
71673543|NCT01256164|142865140|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||intent-to-treat analysis||||0.003
71673544|NCT01436370|142865144|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain.||||0.145
71673545|NCT01436370|142865144|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain||||0.145
71673546|NCT01436370|142865144|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.999
71673547|NCT01436370|142865152|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain||||0.182
71795805|NCT03711162|143089373|SUPERIORITY||LS mean difference|0.3||||0.8617|TWO_SIDED|95.0|-3.4|4.1|||Mixed Models Analysis||LS mean difference (95% CI) per treatment group with treatment, time (categorical), treatment-by-time interaction, stratum and baseline SGRQ total score as fixed effects and participant as random effect.|||4.1|-3.4|0.8617
71795806|NCT03711162|143089374|SUPERIORITY||LS Mean difference|19.4|STANDARD_ERROR_OF_MEAN|33.68|||TWO_SIDED|95.0|-46.9|85.7|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||85.7|-46.9|
71795807|NCT03711162|143089374|SUPERIORITY||LS Mean difference|-29.1|STANDARD_ERROR_OF_MEAN|32.95|||TWO_SIDED|95.0|-93.9|35.8|||||The treatment effect was determined by using estimated slopes for each study group on the basis of the time-by-treatment interaction term from the mixed model.|||35.8|-93.9|
71795808|NCT03711162|143089375|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.68|1.95|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||1.95|0.68|
71795809|NCT03711162|143089375|SUPERIORITY||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.74|2.09|||||Odds ratio and 95% confidence interval originated from a logistic regression.|||2.09|0.74|
71795810|NCT03711162|143089376|SUPERIORITY||LS mean difference|3.7|||||TWO_SIDED|95.0|-11.5|19.0|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||19.0|-11.5|
71795811|NCT03711162|143089376|SUPERIORITY||LS mean difference|2.9|||||TWO_SIDED|95.0|-11.1|16.8|||||The treatment effect was determined by using estimated least square mean difference between each active treatment group and placebo from the mixed model.|||16.8|-11.1|
71840088|NCT04409353|143188771|OTHER||Odds Ratio (OR)|0.83||||0.514|TWO_SIDED|95.0|0.48|1.44||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||1.44|0.48|0.514
71893159|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.6699|TWO_SIDED|95.0|-2.37|1.53|||t-test, 2 sided|||Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.||1.53|-2.37|0.6699
71673548|NCT01436370|142865152|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.||||0.500
71673549|NCT01436370|142865152|SUPERIORITY_OR_OTHER|||||||0.087|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.||||0.087
71673550|NCT01436370|142865153|SUPERIORITY_OR_OTHER|||||||0.234|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 7.||||0.234
71673551|NCT01436370|142865153|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 180.||||0.250
71795812|NCT03711162|143089377|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.65|1.78|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.78|0.65|
71795813|NCT03711162|143089377|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.76|1.98|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause hospitalization.|||1.98|0.76|
71795814|NCT03711162|143089380|SUPERIORITY||Hazard Ratio (HR)|1.29|||||TWO_SIDED|95.0|0.44|3.81|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.81|0.44|
71795815|NCT03711162|143089380|SUPERIORITY||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|0.42|3.5|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first acute IPF exacerbation.|||3.50|0.42|
71795816|NCT03711162|143089381|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||4.08|0.66|
71795817|NCT03711162|143089381|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality or hospitalization for non-elective lung transplant.|||2.61|0.36|
71795818|NCT03711162|143089382|SUPERIORITY||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.66|4.08|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||4.08|0.66|
71795819|NCT03711162|143089382|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.36|2.61|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all cause mortality, hospitalization for non-elective lung transplant or hospitalization for qualifying for lung transplant.|||2.61|0.36|
71673552|NCT01436370|142865153|SUPERIORITY_OR_OTHER|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.||||0.145
71673553|NCT01436370|142865153|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.||||0.500
71673554|NCT01436370|142865153|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.999
71673555|NCT01436370|142865153|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.500
71673556|NCT01436370|142865154|SUPERIORITY_OR_OTHER|||||||0.716|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.||||0.716
71673557|NCT01436370|142865154|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.||||0.999
71795820|NCT03711162|143089383|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.91|0.59|
71795821|NCT03711162|143089383|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to first all-cause mortality or hospitalization that meets \>=10% absolute decline in %FVC or respiratory-related hospitalization.|||1.46|0.43|
71795822|NCT03711162|143089384|SUPERIORITY||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.59|1.91|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.91|0.59|
71795823|NCT03711162|143089384|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.43|1.46|||||Hazard ratio and 95% confidence interval originated from a Cox proportional hazards model for time to all-cause mortality or respiratory-related hospitalizations.|||1.46|0.43|
71795824|NCT03034954|143089405|OTHER|||||||0.3||||||Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.|Repeated Measures ANOVA|repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)||We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.||||.300
71795825|NCT03034954|143089407|OTHER|||||||0.044||||||Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).|Repeated Measures ANOVA|||A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)||||.044
71795826|NCT03034954|143089407|OTHER|||||||0.006|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.006
71893160|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0055|TWO_SIDED|95.0|-3.98|-0.7|||t-test, 2 sided|||Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||-0.70|-3.98|0.0055
71673558|NCT01436370|142865154|SUPERIORITY_OR_OTHER|||||||0.503|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.||||0.503
71673559|NCT01436370|142865154|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.||||0.475
71673560|NCT01436370|142865154|SUPERIORITY_OR_OTHER|||||||0.182|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.||||0.182
71673561|NCT01436370|142865154|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.||||0.014
71673562|NCT01436370|142865156|SUPERIORITY_OR_OTHER|||||||0.317|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.317
71673563|NCT01436370|142865156|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.564
71673564|NCT01436370|142865156|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.999
71673565|NCT01436370|142865156|SUPERIORITY_OR_OTHER|||||||0.564|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.||||0.564
71673566|NCT01436370|142865156|SUPERIORITY_OR_OTHER|||||||0.999|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.||||0.999
71673567|NCT01436370|142865156|SUPERIORITY_OR_OTHER|||||||0.655|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.655
71673568|NCT01436370|142865157|SUPERIORITY_OR_OTHER|||||||0.18|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.||||0.180
71795827|NCT03034954|143089410|OTHER|||||||0.15|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.15
71795828|NCT03034954|143089412|OTHER|||||||0.3|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).||||.3
71795829|NCT03034954|143089417|OTHER|||||||0.45|||||||MANOVA|||A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').||||.450
71795830|NCT03034954|143089418|OTHER|||||||0.078|||||||Chi-squared|||Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition||||.078
71795831|NCT03034954|143089419|OTHER|||||||0.233|||||||Fisher Exact|||||||.233
71795832|NCT03034954|143089421|OTHER|||||||0.6|||||||Fisher Exact|||||||.600
71795833|NCT03034954|143089422|OTHER|||||||0.999|||||||Fisher Exact|||||||.999
71795834|NCT03034954|143089423|OTHER|||||||0.281|||||||Fisher Exact|||||||.281
71795835|NCT03034954|143089424|OTHER|||||||0.082|||||||Fisher Exact|||||||.082
71795836|NCT03034954|143089425|OTHER|||||||0.49|||||||Fisher Exact|||||||.490
71795837|NCT03034954|143089426|OTHER|||||||0.488|||||||Fisher Exact|||||||.488
71795838|NCT03034954|143089427|OTHER|||||||0.219|||||||Fisher Exact|||||||.219
71795839|NCT00394212|143089448|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.|Wilcoxon (Mann-Whitney)|||Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.||||0.066
71795840|NCT00394212|143089449|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.|Fisher Exact|||||||0.317
71795841|NCT00394212|143089450|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.019
71795842|NCT00394212|143089451|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value from two-sided Fisher's exact test comparing percents achieved for the two treatments.|Fisher Exact|||||||0.174
71795843|NCT03240133|143089454|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-6.98||||0.0024|TWO_SIDED|95.0|-11.37|-2.6|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 750mg berotralstat or placebo.||-2.6|-11.37|0.0024
71795844|NCT03240133|143089454|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|-2.1||||0.6424|TWO_SIDED|95.0|-11.49|7.29|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 500mg berotralstat or placebo.||7.29|-11.49|0.6424
71840089|NCT04409353|143188771|OTHER||Odds Ratio (OR)|1.35||||0.28|TWO_SIDED|95.0|0.78|2.36||A two-sided test performed at the 0.05 level of significance.|Regression, Logistic||Sham VR as the reference group.|"Responder status (Yes vs. No) will be analyzed as the dependent variable using logistic regression, with terms for treatment groups and baseline PROMIS-PI as predictors. The null hypothesis is that there is no difference between the treatment groups, versus the alternative hypothesis that there a difference exists between the treatment groups."||2.36|0.78|0.280
71840090|NCT02696707|143188794|NON_INFERIORITY|The non-inferiority margin between groups was set as 4%|Difference|-0.6|||||TWO_SIDED|95.0|-2.5|1.2||||||||1.2|-2.5|
71840091|NCT05292872|143188801|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.143|0.752||1-sided p-values are proportion of bootstrap replicates exceeding null (defined as a HR of 1) in each direction), and the two-tailed p-value is twice the smaller of one-tailed p-values. A two-tailed p-value was calculated for HR using this method.|Nonparametric bootstrap approach|||||0.752|0.143|<.001
71840092|NCT05260112|143188805|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71840093|NCT05260112|143188806|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71840094|NCT05260112|143188807|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71795845|NCT03240133|143089454|SUPERIORITY|Comparisons were performed separately at each time point using a mixed effect linear model including treatment, period and sequence as fixed effects, subject within sequence as a random effect, and predose 3-symptom composite VAS score as a covariate.|Difference in Least Square Means|0.57||||0.8283|TWO_SIDED|95.0|-4.9|6.03|||Mixed effect linear model|||Change in HAE attack symptoms from pre-dose to 4 hours post-dose was assessed following treatment with either 250mg berotralstat or placebo.||6.03|-4.9|0.8283
71795846|NCT03240133|143089455|SUPERIORITY||Odds Ratio (OR)|0.196||||0.0029|TWO_SIDED|95.0|0.069|0.559|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 750 mg-treated-attack requiring SOC-Rx was 0.196 that of a placebo attack.||0.559|0.069|0.0029
71795847|NCT03240133|143089455|SUPERIORITY||Odds Ratio (OR)|0.472||||0.4048|TWO_SIDED|95.0|0.074|2.988|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 500 mg-treated-attack requiring SOC-Rx was 0.472 that of a placebo attack.||2.988|0.074|0.4048
71795848|NCT03240133|143089455|SUPERIORITY||Odds Ratio (OR)|0.587||||0.5984|TWO_SIDED|95.0|0.073|4.733|||logistic mixed effect model|||Analyses were performed using a generalized logistic model including treatment, period and sequence as fixed effects, and subject within sequence as a random effect. The odds of a berotralstat 250 mg-treated-attack requiring SOC-Rx was 0.587 that of a placebo attack.||4.733|0.073|0.5984
71795849|NCT00116831|143089501|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma volume|-4.58||||||95.0||||||||||||
71795850|NCT00116831|143089502|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen volume|0.32||||||95.0||||||||||||
71795851|NCT00116831|143089503|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel volume|-3.56||||||95.0||||||||||||
71795852|NCT00116831|143089505|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for atheroma area|-0.13||||||95.0||||||||||||
71795853|NCT00116831|143089506|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for lumen area|0.02||||||95.0||||||||||||
71795854|NCT00116831|143089507|SUPERIORITY_OR_OTHER||Mean diff (RSG-GLP) for vessel area|-0.11||||||95.0||||||||||||
71795855|NCT00116831|143089510|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.64||||0.1221||95.0|-1.457|0.173|||ANCOVA|||||0.173|-1.457|0.1221
71795856|NCT00116831|143089511|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-5.12||||||95.0||||||||||||
71795857|NCT00116831|143089513|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-1.72||||||95.0||||||||||||
71795858|NCT00116831|143089515|SUPERIORITY_OR_OTHER||Model adjusted mean diff. (RSG-GLP)|-0.11||||||95.0||||||||||||
71795859|NCT00116831|143089516|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.1||||||95.0||||||||||||
71795860|NCT00116831|143089517|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.88||||||95.0||||||||||||
71673569|NCT01436370|142865157|SUPERIORITY_OR_OTHER|||||||0.763|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.763
71673570|NCT01436370|142865157|SUPERIORITY_OR_OTHER|||||||0.096|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.096
71673571|NCT01436370|142865157|SUPERIORITY_OR_OTHER|||||||0.157|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21||||0.157
71673572|NCT01436370|142865157|SUPERIORITY_OR_OTHER|||||||0.705|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.||||0.705
71673573|NCT01436370|142865157|SUPERIORITY_OR_OTHER|||||||0.132|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.||||0.132
71673574|NCT04229095|142865179|SUPERIORITY||Slope|-4.58|STANDARD_ERROR_OF_MEAN|1.82||0.007|ONE_SIDED|95.0||-1.01|||Mixed Models Analysis||The effect of the drug on lowering VAS was limited to individuals with impaired sleep at baseline (PSQI \> or = to 5).|Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictors were drug condition, and baseline sleep disturbance (Pittsburgh Sleep Quality Index {PSQI} total score less than 5 or 5 and greater). Arms were combined for this analysis.||-1.01||.007
71673575|NCT04229095|142865181|SUPERIORITY||Mean Difference (Net)|-1.52|STANDARD_ERROR_OF_MEAN|0.54||0.0025|ONE_SIDED|95.0||-0.46|||Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces number of drinks per day. Principle predictors were drug condition and sex. Arms were combined for this analysis.||-0.46||.0025
71673576|NCT01780038|142865183|OTHER||||||||||||||||||Frequencies and percentages were used to determine this secondary outcome.|||
71673577|NCT01085630|142865186|SUPERIORITY|||||||0.2423|||||||Fisher Exact|||||||0.2423
71673578|NCT01237041|142865188|SUPERIORITY|Univariate ANOVA||||||0.016||||||A priori threshold p\<0.05|ANOVA|Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.||ANOVA to compare AUC of GH among groups||||.016
71840095|NCT05260112|143188808|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71840096|NCT05260112|143188809|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71840097|NCT05260112|143188810|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71840098|NCT03798093|143188853|SUPERIORITY||least squares|-0.112||||0.08|TWO_SIDED|95.0|-29.3|1.7|||Regression, Linear|||||1.7|-29.3|0.08
71893161|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.2793|TWO_SIDED|95.0|-2.92|0.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.85|-2.92|0.2793
71673579|NCT01237041|142865189|SUPERIORITY|ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis||||||0.043||||||A priori threshold for significance p\<0.05|ANOVA|||Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.||||.043
71673580|NCT01237041|142865190|SUPERIORITY|||||||0.543|||||||ANOVA|||ANOVA, 3 dose-finding groups||||0.543
71673581|NCT01237041|142865191|SUPERIORITY|||||||0.113|||||||ANOVA|||ANOVA, 2 groups, essentially an unpaired t-test.||||.113
71673582|NCT00651261|142865207|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.009|TWO_SIDED|95.0|0.63|0.96|||1-sided stratified log-rank|||||0.96|0.63|0.009
71673583|NCT00651261|142865208|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.0024|TWO_SIDED|95.0|0.66|0.93|||1-sided stratified log rank|||||0.93|0.66|0.0024
71673584|NCT00651261|142865210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|||||||Fisher Exact|||||||0.15
71673585|NCT00651261|142865211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||1-sided stratified log rank|||||||0.0049
71673586|NCT05483686|142865213|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||This analysis aims to detect a significant change (p = .05) in percentage of participants with HIV transmission risk between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.19
71673587|NCT05483686|142865214|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in ART adherence between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||=.24
71673588|NCT05483686|142865215|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.79
71673589|NCT05483686|142865216|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to ART use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
71673590|NCT05483686|142865217|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to PrEP use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.14
71673591|NCT05483686|142865218|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in barriers to condom use between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.81
71673592|NCT05483686|142865219|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in social support between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.30
71673593|NCT05483686|142865220|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||This analysis aims to detect a significant change (p = .05) in gender identity comfort between Shine Intervention participants and Control Videos participants from Baseline to Month 6.||||.94
71840099|NCT04119843|143188946|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.824|<|0.001|TWO_SIDED|95.0|0.743|1.165|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.165|0.743|<0.001
71893162|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.2999|TWO_SIDED|95.0|-3.17|0.99|||t-test, 2 sided|||Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.99|-3.17|0.2999
71795861|NCT00116831|143089518|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-47.23||||||95.0||||||||||||
71795862|NCT00116831|143089519|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-16.9||||||95.0||||||||||||
71795863|NCT00116831|143089521|SUPERIORITY_OR_OTHER||Ratio to GLP as % difference from GLP|30.591||||||95.0||||||||||||
71795864|NCT00116831|143089522|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.642||||||95.0||||||||||||
71795865|NCT00116831|143089523|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|7.316||||||95.0||||||||||||
71795866|NCT00116831|143089524|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|15.731||||||95.0||||||||||||
71795867|NCT00116831|143089525|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|3.998||||||95.0||||||||||||
71795868|NCT00116831|143089526|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|11.728||||||95.0||||||||||||
71795869|NCT00116831|143089527|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-6.768||||||95.0||||||||||||
71795870|NCT00116831|143089528|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-14.478||||||95.0||||||||||||
71795871|NCT00116831|143089529|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|-0.462||||||95.0||||||||||||
71795872|NCT00116831|143089530|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.0164||||||95.0||||||||||||
71893163|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.327|TWO_SIDED|95.0|-3.82|1.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.29|-3.82|0.3270
71795873|NCT00116831|143089531|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.118||||||95.0||||||||||||
71795874|NCT00116831|143089532|SUPERIORITY_OR_OTHER||Treatment difference (RSG-GLP)|0.14||||||95.0||||||||||||
71795875|NCT00380393|143089536|OTHER||Vaccine Efficacy|52.9|||<|0.001|TWO_SIDED|95.0|28.1|69.1|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum||69.1|28.1|<0.001
71795876|NCT00380393|143089536|OTHER||Vaccine Efficacy|55.0|||<|0.001|TWO_SIDED|95.0|31.4|70.4|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum||70.4|31.4|<0.001
71795877|NCT00380393|143089537|OTHER||Vaccine efficacy|54.6|||<|0.001|TWO_SIDED|95.0|31.2|70.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||70.0|31.2|<0.001
71795878|NCT00380393|143089537|OTHER||Vaccine efficacy|56.5|||<|0.001|TWO_SIDED|95.0|34.2|71.2|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum.||71.2|34.2|<0.001
71795879|NCT00380393|143089538|OTHER||Vaccine efficacy|55.8||||0.0003|TWO_SIDED|95.0|31.0|71.7|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||71.7|31.0|0.0003
71795880|NCT00380393|143089538|OTHER||Vaccine efficacy|57.9|||<|0.001|TWO_SIDED|95.0|34.3|73.0|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.3|<0.001
71795881|NCT00380393|143089539|OTHER||Vaccine efficacy|58.0|||<|0.001|TWO_SIDED|95.0|34.8|73.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.0|34.8|<0.001
71795882|NCT00380393|143089539|OTHER||Vaccine efficacy|59.5|||<|0.001|TWO_SIDED|95.0|37.1|73.9|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.||73.9|37.1|<0.001
71795883|NCT00110812|143089558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|134.0|||<|0.001|TWO_SIDED|95.0|70.0|198.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||198|70|<.001
71795884|NCT00110812|143089558|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|133.0|||<|0.001|TWO_SIDED|95.0|68.0|199.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.||||199|68|<.001
71795885|NCT00110812|143089560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.31||||0.01|TWO_SIDED|95.0|0.08|0.54|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.54|.08|.01
71795886|NCT00110812|143089560|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.36||||0.003|TWO_SIDED|95.0|0.12|0.6|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.||||.60|.12|.003
71795887|NCT00110812|143089561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|65.8||||0.009||95.0|||||ANOVA|ANOVA with stratification by region and adjustment for baseline CD4||||||.009
71795888|NCT00110812|143089561|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|58.2||||0.02||95.0|||||ANOVA|stratified by region and adjusted for baseline CD4||||||.02
71795889|NCT00110812|143089564|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.08||||0.14|TWO_SIDED|95.0|0.59|43.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 alone compared to patients not taking IL-2.|||43.6|0.59|.14
71795890|NCT00110812|143089564|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.56||||0.08|TWO_SIDED|95.0|0.8|53.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2|||53.6|0.80|.08
71795891|NCT00110812|143089565|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58||||0.048|TWO_SIDED|95.0|0.34|0.99|||Regression, Cox||IL-2 without ART vs control group|||.99|.34|.048
71795892|NCT00110812|143089565|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.62|||Regression, Cox||IL-2 with pericycle HAART compared to control|||.62|.17|<.001
71795893|NCT00110812|143089566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.03|TWO_SIDED|95.0|0.03|0.64|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.64|0.03|.03
71795894|NCT00110812|143089566|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.54|||<|0.001|TWO_SIDED|95.0|0.24|0.85|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA||||0.85|0.24|<.001
71795895|NCT00110812|143089569|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.45||||0.59|TWO_SIDED|95.0|0.38|5.45|||Regression, Cox|Stratification by region.|IL-2 group compared to control group|||5.45|0.38|.59
71795896|NCT00110812|143089570|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-55.9|STANDARD_ERROR_OF_MEAN|28.4||0.05||95.0|||||ANOVA|Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.|IL-2 group minus control group CD4.|||||.05
71893164|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9779|TWO_SIDED|95.0|-2.39|2.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.45|-2.39|0.9779
71795897|NCT00110812|143089572|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.03|TWO_SIDED|95.0|0.52|0.97|||Regression, Cox||IL-2 groups vs. control|||.97|.52|.03
71893165|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.8344|TWO_SIDED|95.0|-4.25|3.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||3.45|-4.25|0.8344
71673594|NCT01543178|142865229|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED|||||The a priori threshold for statistical significance was p \< 0.05.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel method was adjusted for analysis center and time to recurrence during Maintenance Phase 1.||A worst case analysis was performed, in which patients with \< 4 days of IBS symptom data in a given week were considered as non-responders for that week.||||0.0232
71795898|NCT01933048|143089573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.43|||||||Farrington-Manning Method|based on margin of 0.05||A/H1N1||||0.43
71795899|NCT01933048|143089573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.8|||||||Farrington-Manning Method|based on margin of 0.05||A/H3N2||||0.80
71795900|NCT01933048|143089573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.55|||||||Farrington-Manning Method|based on margin of 0.05||B/Yamagata||||0.55
71795901|NCT01933048|143089573|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority||||||0.16|||||||Farrington-Manning Method|based on margin of 0.05||B/Brisbane||||0.16
71795902|NCT01921829|143089593|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71795903|NCT01921829|143089594|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
71795904|NCT01921829|143089596|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
71795905|NCT01921829|143089597|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
71795906|NCT01921829|143089598|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
71795907|NCT01921829|143089599|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
71673595|NCT03351608|142865236|SUPERIORITY||GM Ratio (SUG 2 mg / NEO + [GLY or ATR])|0.22|||<|0.0001|TWO_SIDED|95.0|0.16|0.32|||ANOVA|||||0.32|0.16|< 0.0001
71795908|NCT01921829|143089600|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
71795909|NCT01921829|143089601|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71795910|NCT01921829|143089602|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
71795911|NCT01921829|143089603|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71795912|NCT01921829|143089604|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
71795913|NCT01921829|143089605|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
71795914|NCT01921829|143089606|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71795915|NCT01921829|143089607|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71795916|NCT01921829|143089608|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71795917|NCT01921829|143089609|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
71795918|NCT01921829|143089610|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
71795919|NCT01921829|143089611|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71795920|NCT01921829|143089612|SUPERIORITY||||||>|0.95|||||||t-test, 2 sided|||||||>0.95
71795921|NCT01921829|143089613|SUPERIORITY||||||>|0.95|||||||Fisher Exact|||||||>0.95
71795922|NCT04476030|143089614|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.55||0.0004|TWO_SIDED|95.0|-3.0|-0.9|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.9|-3.0|0.0004
71795923|NCT04476030|143089615|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.56||0.0054|TWO_SIDED|95.0|-2.7|-0.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||-0.5|-2.7|0.0054
71795924|NCT04476030|143089616|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.7||0.2477|TWO_SIDED|95.0|-2.2|0.6|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 15||0.6|-2.2|0.2477
71795925|NCT04476030|143089616|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9248|TWO_SIDED|95.0|-1.6|1.5|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|Day 42||1.5|-1.6|0.9248
71795926|NCT04476030|143089617|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.65||0.4458|TWO_SIDED|95.0|-1.8|0.8|||MMRM||Model used was the MMRM with treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-1.8|0.4458
71795927|NCT04476030|143089618|SUPERIORITY||Odds Ratio (OR)|1.15||||0.4946|TWO_SIDED|95.0|0.78|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15|Generalized estimating equation is abbreviated as GEE in the method of estimation section.|1.69|0.78|0.4946
71795928|NCT04476030|143089618|SUPERIORITY||Odds Ratio (OR)|0.82||||0.3579|TWO_SIDED|95.0|0.55|1.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.24|0.55|0.3579
71795929|NCT04476030|143089619|SUPERIORITY||Odds Ratio (OR)|1.41||||0.1417|TWO_SIDED|95.0|0.89|2.24|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||2.24|0.89|0.1417
71795930|NCT04476030|143089619|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7872|TWO_SIDED|95.0|0.62|1.44|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline HAMD-17 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 42||1.44|0.62|0.7872
71893166|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.46||||0.5494|TWO_SIDED|95.0|-3.5|6.41|||t-test, 2 sided|||Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||6.41|-3.50|0.5494
71840100|NCT04119843|143188946|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|0.892|<|0.001|TWO_SIDED|95.0|0.552|1.043|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.043|0.552|<0.001
71840101|NCT04119843|143188946|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|0.622|<|0.001|TWO_SIDED|95.0|0.494|0.813|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.813|0.494|<0.001
71840102|NCT04119843|143188947|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.98|STANDARD_DEVIATION|0.853|<|0.001|TWO_SIDED|95.0|0.759|1.196|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 1||1.196|0.759|<0.001
71840103|NCT04119843|143188947|SUPERIORITY|Reader success of the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.909|<|0.001|TWO_SIDED|95.0|0.766|1.267|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 2||1.267|0.766|<0.001
71840104|NCT04119843|143188947|SUPERIORITY|Reader success for the primary analysis was achieved if the reading results demonstrated superiority of combined MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.678|<|0.001|TWO_SIDED|95.0|0.638|0.985|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (combined MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of combined MRI versus unenhanced MRI: Reader 3||0.985|0.638|<0.001
71840105|NCT04119843|143188949|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.805|<|0.001|TWO_SIDED|95.0|0.555|0.971|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||0.971|0.555|<0.001
71840106|NCT04119843|143188949|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|1.059|<|0.001|TWO_SIDED|95.0|0.464|1.054|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.054|0.464|<0.001
71840107|NCT04119843|143188949|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|0.609|<|0.001|TWO_SIDED|95.0|0.429|0.747|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion border delineation mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.747|0.429|<0.001
71840108|NCT04119843|143188950|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.95|STANDARD_DEVIATION|0.852|<|0.001|TWO_SIDED|95.0|0.726|1.166|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 1||1.166|0.726|<0.001
71840109|NCT04119843|143188950|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|1.261|<|0.001|TWO_SIDED|95.0|0.38|1.082|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 2||1.082|0.380|<0.001
71795931|NCT04476030|143089620|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1993|TWO_SIDED|95.0|-0.4|0.1|||MMRM||Model used was the MMRM with treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.1|-0.4|0.1993
71795932|NCT04476030|143089621|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0079|TWO_SIDED|95.0|1.21|3.47|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 3||3.47|1.21|0.0079
71795933|NCT04476030|143089621|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6588|TWO_SIDED|95.0|0.74|1.62|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline CGI-S score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|Day 15||1.62|0.74|0.6588
71795934|NCT04476030|143089622|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.06||0.2322|TWO_SIDED|95.0|-3.4|0.8|||MMRM||Model used was the MMRM with treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.8|-3.4|0.2322
71795935|NCT04476030|143089623|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5439|TWO_SIDED|95.0|0.76|1.68|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.68|0.76|0.5439
71795936|NCT04476030|143089624|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7054|TWO_SIDED|95.0|0.7|1.69|||Binary Response Model||GEE for binary response model was used with factors for treatment, baseline MADRS total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction with unstructured covariance structure.|||1.69|0.70|0.7054
71795937|NCT04476030|143089625|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62||0.4188|TWO_SIDED|95.0|-1.7|0.7|||MMRM||Model used was the MMRM with treatment, baseline HAM-A total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||0.7|-1.7|0.4188
71893167|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.0136|TWO_SIDED|95.0|3.15|22.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||22.85|3.15|0.0136
71893168|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.78||||0.0247|TWO_SIDED|95.0|2.26|25.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||25.29|2.26|0.0247
71795938|NCT04476030|143089627|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7758|TWO_SIDED|95.0|-1.4|1.0|||MMRM||Model used was the MMRM with treatment, baseline PHQ-9 total score, antidepressant use (SSRI/SNRI), assessment time point, and time point-by-treatment interaction as fixed effects with unstructured covariance structure.|||1.0|-1.4|0.7758
71795939|NCT02404311|143089659|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
71795940|NCT02404311|143089659|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
71795941|NCT02404311|143089659|OTHER||Proportion Difference (Net)|-0.015||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
71893169|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.3527|TWO_SIDED|95.0|-12.91|22.91|||t-test, 2 sided|||Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||22.91|-12.91|0.3527
71893170|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71893171|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.76||||0.1309|TWO_SIDED|95.0|-4.05|0.53|||t-test, 2 sided|||Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.||0.53|-4.05|0.1309
71893172|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.36||||0.051|TWO_SIDED|95.0|-2.72|0.01|||t-test, 2 sided|||Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.01|-2.72|0.0510
71893173|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.3858|TWO_SIDED|95.0|-2.44|0.95|||t-test, 2 sided|||Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.95|-2.44|0.3858
71893174|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.88||||0.3943|TWO_SIDED|95.0|-2.9|1.15|||t-test, 2 sided|||Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||1.15|-2.90|0.3943
71893175|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.3499|TWO_SIDED|95.0|-3.53|1.27|||t-test, 2 sided|||Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||1.27|-3.53|0.3499
71893176|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.9567|TWO_SIDED|95.0|-2.64|2.5|||t-test, 2 sided|||Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||2.50|-2.64|0.9567
71893177|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.77||||0.2901|TWO_SIDED|95.0|-5.12|1.58|||t-test, 2 sided|||Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.58|-5.12|0.2901
71893178|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.5857|TWO_SIDED|95.0|-5.05|2.92|||t-test, 2 sided|||Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||2.92|-5.05|0.5857
71893179|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.9635|TWO_SIDED|95.0|-12.56|12.02|||t-test, 2 sided|||Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||12.02|-12.56|0.9635
71795942|NCT02404311|143089660|OTHER||Geometric Mean difference (Net)|0.914|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 1086C\_D7gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
71795943|NCT02404311|143089660|OTHER||Geometric Mean difference (Net)|0.945|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to 96ZM651.D11gp120.avi after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
71795944|NCT02404311|143089660|OTHER||Geometric Mean difference (Net)|0.895|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to TV1c8\_D11gp120.avi/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
71795945|NCT02404311|143089661|OTHER||Proportion Difference (Net)|0.0||||0.0215|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0215
71795946|NCT02404311|143089661|OTHER||Proportion Difference (Net)|0.0||||0.0003|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0003
71795947|NCT02404311|143089661|OTHER||Proportion Difference (Net)|0.228||||0.001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0010
71840110|NCT04119843|143188950|SUPERIORITY|Reader success was achieved if the reading results demonstrated superiority of mangoral-enhanced MRI versus unenhanced MRI for both lesion border delineation and lesion contrast. The acceptance by two out of three readers was considered to be a successful demonstration of efficacy in the study.|Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.786|<|0.001|TWO_SIDED|95.0|0.517|0.927|||t-test, 1 sided|p-values show a one-sided t-test with a significance level of 0.025.|Positive changes in lesion contrast mean difference (mangoral-enhanced MRI compared to unenhanced MRI) represents a better outcome.|Paired difference of mangoral-enhanced MRI versus unenhanced MRI: Reader 3||0.927|0.517|<0.001
71840111|NCT03994653|143188990|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.07|4.12|||Fisher Exact|||"Fishers exact test, conducted at each month prior to diagnosis comparing total purchases of relevant products (pain and indigestion medication) compared with all purchases in both cases and controls.~Power calculation: we used a power calculation assuming the Fisher Exact Test to calculate the minimum group size to detect a difference in purchase proportions that we hypothesised with 80% statistical power."||4.12|2.07|<0.001
71840112|NCT03532282|143189035|SUPERIORITY||coefficient beta for change trajectory|-0.15||||0.001|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.001
71840113|NCT03532282|143189036|SUPERIORITY||coefficient beta for change trajectory|-0.01||||0.01|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.01
71840114|NCT03532282|143189037|SUPERIORITY||coefficient beta for change trajectory|-0.24||||0.0006|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.0006
71840115|NCT03532282|143189038|SUPERIORITY||coefficient beta for change trajectory|-0.04||||0.05|TWO_SIDED|||||The a-priori threshold for statistical significance was 0.05|Mixed Models Analysis|Mixed effects model incorporating all assessment time points.||||||0.05
71840116|NCT05651308|143189081|SUPERIORITY||Risk Difference (RD)|0.026||||0.37|TWO_SIDED|95.0|-0.03|0.08|||Chi-squared||Risk difference = Intervention proportion minus control proportion.|||0.08|-0.03|0.37
71840117|NCT02714257|143189085|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.74|1.14|||Regression, Cox||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.14|0.74|0.43
71840118|NCT02714257|143189086|SUPERIORITY||Incidence Rate Ratio|1.06||||0.5|TWO_SIDED|95.0|0.89|1.28|||Regression, Negative Binomial||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.28|0.89|0.50
71840119|NCT02714257|143189087|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3|TWO_SIDED|95.0|0.72|1.11|||Regression, Logistic|||||1.11|0.72|0.30
71840120|NCT02714257|143189088|SUPERIORITY||Mean Difference (Final Values)|0.54|||<|0.01|TWO_SIDED|95.0|0.16|0.92|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.92|0.16|<0.01
71840121|NCT02714257|143189089|SUPERIORITY||Odds Ratio (OR)|1.04||||0.73|TWO_SIDED|95.0|0.85|1.27|||Regression, Logistic||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||1.27|0.85|0.73
71840122|NCT02714257|143189090|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.27|TWO_SIDED|95.0|-0.18|0.62|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.62|-0.18|0.27
71840123|NCT02714257|143189091|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.37|TWO_SIDED|95.0|-0.13|0.34|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.34|-0.13|0.37
71840124|NCT02714257|143189092|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.26|TWO_SIDED|95.0|-0.1|0.38|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.38|-0.10|0.26
71840125|NCT02714257|143189093|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.39|TWO_SIDED|95.0|-0.09|0.22|||Mixed Models Analysis||Enhanced Usual Care - control group vs. Enhanced Usual Care plus Exercise Coaching Intervention|||0.22|-0.09|0.39
71840126|NCT05825755|143189094|SUPERIORITY|||||||0.252|||||||Wilcoxon (Mann-Whitney)|||||||0.252
71840127|NCT05825755|143189095|SUPERIORITY|||||||1|||||||McNemar|||||||1.0
71840128|NCT05825755|143189096|SUPERIORITY|||||||0.791|||||||Wilcoxon (Mann-Whitney)|||||||0.791
71893180|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.685|TWO_SIDED|95.0|-15.36|10.56|||t-test, 2 sided|||Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||10.56|-15.36|0.6850
71795948|NCT02404311|143089662|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to C.1086C\_V1\_V2 Tags after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
71673596|NCT02877004|142865239|SUPERIORITY|||||||0.723|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate.||||||0.723
71795949|NCT02404311|143089662|OTHER||Geometric Mean difference (Net)|0.0|||<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-96ZM651.02 V1v2 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||<.0001
71795950|NCT02404311|143089662|OTHER||Geometric Mean difference (Net)|6.099||||0.0002|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|IgG Ab binding to gp70-TV1.GSKvacV1V2/293F after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.0002
71795951|NCT02404311|143089663|OTHER||Proportion Difference (Net)|0.018||||1|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||1.0000
71795952|NCT02404311|143089663|OTHER||Proportion Difference (Net)|0.036||||0.6698|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.6698
71795953|NCT02404311|143089663|OTHER||Proportion Difference (Net)|0.125||||0.1435|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|McNemar||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.1435
71795954|NCT02404311|143089664|OTHER||Geometric Mean difference (Net)|0.965||||0.9661|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to 1086 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.9661
71673597|NCT02877004|142865240|SUPERIORITY|||||||0.368|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate||||||.368
71673598|NCT02727478|142865241|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||< 0.001
71673599|NCT02727478|142865242|SUPERIORITY||||||=|0.001|||||||ANOVA|||||||=0.001
71795955|NCT02404311|143089664|OTHER||Geometric Mean difference (Net)|1.118||||0.8593|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to TV1 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.8593
71673600|NCT02727478|142865243|OTHER|||||||0.254|||||||Wilcoxon (Mann-Whitney)|||||||0.254
71673601|NCT02727478|142865244|SUPERIORITY||||||=|0.065|||||||Wilcoxon (Mann-Whitney)|||||||=0.065
71673602|NCT02727478|142865245|SUPERIORITY||||||=|0.301|||||||ANOVA|||||||=0.301
71673603|NCT02727478|142865246|SUPERIORITY||||||=|0.792|||||||ANOVA|||||||=0.792
71840129|NCT04103580|143189101|SUPERIORITY||Slope|0.005|STANDARD_ERROR_OF_MEAN|0.005||0.247|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.247
71840130|NCT04103580|143189101|SUPERIORITY||Slope|-0.008|STANDARD_ERROR_OF_MEAN|0.004||0.049|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.049
71673604|NCT02727478|142865247|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71673605|NCT01081769|142865340|SUPERIORITY_OR_OTHER|||||||0.0191|||||||Log Rank|||||||0.0191
71673606|NCT01081769|142865354|SUPERIORITY_OR_OTHER|||||||0.0323|||||||Fisher Exact|||||||0.0323
71795956|NCT02404311|143089664|OTHER||Geometric Mean difference (Net)|1.138||||0.4396|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon Signed-Rank||Difference = Month 12.5 (5th vaccination) - Month 6.5 (4th vaccination)|CD4+ T Cell Responses to ZM96 gp120 after the fourth (month 6.5) versus the fifth vaccination (month 12.5)||||0.4396
71795957|NCT00218296|143089671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.04|TWO_SIDED|95.0|0.26|0.99|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.99|0.26|0.04
71795958|NCT00218296|143089672|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28||||0.019|TWO_SIDED|95.0|0.07|0.83|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.83|0.07|0.019
71795959|NCT00218296|143089673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.03|TWO_SIDED|95.0|0.18|0.94|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.94|0.18|0.03
71758476|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.47|||<|0.0001|TWO_SIDED|95.0|0.29|0.66|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.66|0.29|<0.0001
71840131|NCT04103580|143189102|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.004||0.15|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 1.||||0.150
71840132|NCT04103580|143189102|SUPERIORITY||Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.004||0.635|TWO_SIDED||||||Mixed Models Analysis|Due to uneven space between time points (days), we estimated a random effects model with varying intercepts and slopes for each phase independently.|We used an interaction between time and study arm to determine whether there was a significant difference over time in the change in outcome. The estimate is the difference in change over time for the intervention group compared to the control group.|The null hypothesis is that there is no difference between control and intervention over time in Phase 2.||||0.635
71840133|NCT00104676|143189112|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.05|TWO_SIDED|95.0|0.44|1.0|||Log Rank|Adjusted on the stratification factor (treatment centers)||To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.||1.00|0.44|0.05
71840134|NCT00104676|143189113|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.34|TWO_SIDED|95.0|0.46|1.31|||Log Rank|Adjusted on the stratification factor (treatment centers)||||1.31|0.46|0.34
71840135|NCT05139810|143189114|SUPERIORITY||IC HAE attack rate ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.107|0.351|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used to account for potential over dispersion.||0.351|0.107|<0.001
71840136|NCT05139810|143189114|SUPERIORITY||IC HAE attack rate ratio|0.45|||=|0.004|TWO_SIDED|95.0|0.261|0.777|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 1 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential overdispersion.||0.777|0.261|=0.004
71840137|NCT05139810|143189115|SUPERIORITY||IC HAE attack rate ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.062|0.281|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.281|0.062|<0.001
71840138|NCT05139810|143189115|SUPERIORITY||IC HAE attack rate ratio|0.4|||=|0.004|TWO_SIDED|95.0|0.212|0.748|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.748|0.212|=0.004
71893181|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.75||||0.4968|TWO_SIDED|95.0|-19.23|11.73|||t-test, 2 sided|||Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||11.73|-19.23|0.4968
71893182|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71893183|NCT00609622|143307428|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5891|TWO_SIDED|95.0|-2.71|1.55|||t-test, 2 sided|||Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.||1.55|-2.71|0.5891
71758477|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.41|0.79|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.79|0.41|<0.0001
71758478|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.29|<0.0001
71758479|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.52|0.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.91|0.52|<0.0001
71893184|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.5081|TWO_SIDED|95.0|-2.5|1.24|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||1.24|-2.50|0.5081
71673607|NCT00507455|142865355|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-6.15|||||TWO_SIDED|95.0|-14.67|2.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.37|-14.67|
71893185|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.6977|TWO_SIDED|95.0|-2.67|1.79|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||1.79|-2.67|0.6977
71893186|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76||||0.0797|TWO_SIDED|95.0|-5.85|0.33|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.33|-5.85|0.0797
71893187|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.5808|TWO_SIDED|95.0|-5.62|3.17|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||3.17|-5.62|0.5808
71673608|NCT00507455|142865355|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-5.0|||||TWO_SIDED|95.0|-13.85|3.84|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.84|-13.85|
71795960|NCT00218296|143089674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|.002
71795961|NCT00218296|143089675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.056|TWO_SIDED|95.0|0.2|1.03|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||1.03|0.20|0.056
71795962|NCT00218296|143089676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09||||0.002|TWO_SIDED|95.0|0.004|0.48||There were no adjustments in the analysis.|Chi-squared||The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.||0.48|0.004|0.002
71795963|NCT03712410|143089721|OTHER|Group Comparisons||||||0.186||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Kruskal-Wallis|||||||0.1860
71795964|NCT03712410|143089721|OTHER|Group Comparisons||||||0.2752||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Kruskal-Wallis|||||||0.2752
71795965|NCT03712410|143089721|OTHER|Group Comparisons||||||0.6233||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Kruskal-Wallis|||||||0.6233
71795966|NCT03712410|143089722|OTHER|Group Comparison||||||0.5638||||||p-value for Difference (FollowUp-Baseline) Generalised Anxiety Disorder Assessment (GAD-7)|Wilcoxon (Mann-Whitney)|||||||0.5638
71795967|NCT03712410|143089722|OTHER|Group Comparisons||||||0.9848||||||p-value for Difference (FollowUp-Baseline) Patient Health Questionnaire 9 (PHQ9)|Wilcoxon (Mann-Whitney)|||||||0.9848
71795968|NCT03712410|143089722|OTHER|Group Comparisons||||||0.9169||||||p-value for Difference (FollowUp-Baseline) Caregiver Quality of Life Index (CQLI-R)|Wilcoxon (Mann-Whitney)|||||||0.9169
71795969|NCT03712410|143089723|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
71795970|NCT03712410|143089723|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
71795971|NCT03712410|143089723|OTHER|Group Comparisons||||||0.0155||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Traditional PISCES|Wilcoxon Signed Rank Test|||||||0.0155
71795972|NCT03712410|143089723|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Generalised Anxiety Disorder Assessment (GAD-7) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
71795973|NCT03712410|143089723|OTHER|Group Comparisons|||||<|0.0001||||||p-value for Patient Health Questionnaire 9 (PHQ9) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||<0.0001
71795974|NCT03712410|143089723|OTHER|Group Comparisons||||||0.0504||||||p-value for Caregiver Quality of Life Index (CQLI-R) for arm Online PISCES|Wilcoxon Signed Rank Test|||||||0.0504
71795975|NCT00746941|143089823|SUPERIORITY_OR_OTHER|||||||0.7132|||||||Student's t-test|||||||0.7132
71795976|NCT00746941|143089824|SUPERIORITY_OR_OTHER|||||||0.9086|||||||Student's t-test|||||||0.9086
71795977|NCT03316885|143089833|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
71795978|NCT03316885|143089834|OTHER|The performance target in support of the primary effectiveness was percentage of eyes achieving objective monocular BCDVA at 1 year postoperative (Visit 5A) compared to the a priori SPE percentage of 92.5%. This is for the All Implanted Analysis Set (AAS) (as reported in EN ISO 11979-7:2014).|Comparison|100.0|||||ONE_SIDED|95.0||100.0||||||||100.0||
71795979|NCT02180412|143089853|OTHER||Slope|7.76||||0.0434|TWO_SIDED|95.0|2.14|13.37|||ANCOVA|||ALA Day 1 vs Day 2||13.37|2.14|.0434
71795980|NCT02180412|143089853|OTHER||Slope|16.29||||0.0003|TWO_SIDED|95.0|11.32|21.25|||ANCOVA|||ALA Day 1 vs Day 3||21.25|11.32|.0003
71795981|NCT02180412|143089853|OTHER||Slope|15.98||||0.0198|TWO_SIDED|95.0|6.7|25.26|||ANCOVA|||ALA Day 1 vs Day 4||25.26|6.7|.0198
71795982|NCT02180412|143089853|OTHER||Slope|10.69||||0.158|TWO_SIDED|95.0|-1.67|22.49|||ANCOVA|||PBG Day 1 vs Day 2||22.49|-1.67|.158
71795983|NCT02180412|143089853|OTHER||Slope|24.52||||0.0127|TWO_SIDED|95.0|11.3|37.74|||ANCOVA|||PGB Day 1 vs Day 3||37.74|11.3|.0127
71795984|NCT02180412|143089853|OTHER||Slope|28.45||||0.0328|TWO_SIDED|95.0|9.64|47.27|||ANCOVA|||PBG Day 1 vs Day 4||47.27|9.64|.0328
71840139|NCT05139810|143189116|SUPERIORITY||Odds Ratio (OR)|11.79|||=|0.003|TWO_SIDED|95.0|2.34|59.36|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||59.36|2.34|=0.003
71840140|NCT05139810|143189116|SUPERIORITY||Odds Ratio (OR)|3.23|||=|0.24|TWO_SIDED|95.0|0.46|22.85|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.||||22.85|0.46|=0.240
71840141|NCT05139810|143189117|SUPERIORITY||IC HAE attack rate ratio|0.11|||<|0.001|TWO_SIDED|95.0|0.035|0.339|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.339|0.035|<0.001
71795985|NCT02180412|143089853|OTHER||Slope|12.2||||0.9993|TWO_SIDED|95.0|-465.4|489.8|||ANCOVA|||Total Porphyrins Day 1 vs Day 2||489.8|-465.4|.9993
71795986|NCT02180412|143089853|OTHER||Slope|454.5||||0.2915|TWO_SIDED|95.0|-200.87|1109.86|||ANCOVA|||Total Porphyrins Day 1 vs Day 3||1109.86|-200.87|.2915
71795987|NCT02180412|143089853|OTHER||Slope|326.12||||0.4382|TWO_SIDED|95.0|-292.0|944.25|||ANCOVA|||Total Porphyrins Day 1 vs Day 4||944.25|-292|.4382
71795988|NCT00405548|143089858|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71795989|NCT00405548|143089859|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71795990|NCT00405548|143089860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71795991|NCT00405548|143089861|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the BNP group.||||0.004
71795992|NCT00405548|143089861|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the Placebo group.||||0.43
71795993|NCT00923559|143089862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.69|STANDARD_ERROR_OF_MEAN|3.04||0.006||95.0|2.64|14.74||Null hypothesis MIP and CHC care should yield equal outcomes. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 68.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||14.74|2.64|.006
71795994|NCT00923559|143089863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.57|STANDARD_ERROR_OF_MEAN|1.06||0.018|TWO_SIDED|95.0|0.46|4.68||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom (df) = 69.3||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||4.68|0.46|.018
71795995|NCT00923559|143089864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.24||0.266|TWO_SIDED|95.0|-0.21|0.75||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|Degrees of freedom = 73.4||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.75|-0.21|.266
71840142|NCT05139810|143189117|SUPERIORITY||IC HAE attack rate ratio|0.59|||=|0.173|TWO_SIDED|95.0|0.276|1.26|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||1.260|0.276|=0.173
71840143|NCT05139810|143189118|SUPERIORITY||Odds Ratio (OR)|310.35|||<|0.001|TWO_SIDED|95.0|11.63|8279.94|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||8279.94|11.63|<0.001
71795996|NCT00923559|143089865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.052|TWO_SIDED|95.0|0.0|0.32||p-value unadjusted for multiple comparisons. A priori threshold p\<.05.|Regression, Linear|||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.32|0.00|.052
71673609|NCT00507455|142865357|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|1.67|||||TWO_SIDED|95.0|0.5|2.85|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||2.85|0.50|
71795997|NCT00923559|143089866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.031|TWO_SIDED|95.0|-1.61|-0.08|||Regression, Linear|Degrees of freedom (df) = 61.2||see under the PIR-GAS||-0.08|-1.61|.031
71795998|NCT00923559|143089867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.158|TWO_SIDED|95.0|-0.05|0.31|||Mixed Models Analysis|Degrees of freedom (df) = 71.2||Null hypothesis: MIP and CHC care should yield equal outcomes. For power calculations, studies on the EPDS and the SPSQ were used. An estimated power of .80 and a two-tailed significance of .05 would necessitate between 29 and 60 participants. Forty dyads per group were chosen.||0.31|-0.05|.158
71795999|NCT04258605|143089884|OTHER|P-values account for preoperative versus postoperative mean values at 1 and 2 years|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<.0001
71796000|NCT04258605|143089885|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
71796001|NCT04258605|143089886|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
71796002|NCT04258605|143089887|OTHER|P-values account for preoperative versus postoperative mean values at 3-6 months, 1 year, 2 and 3 years|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||"The small sample size of arm ASHCOM Shoulder System subjects - Fracture humeral stem of 2 cases is too low for a statistical analysis."||||<0.001
71796003|NCT00181961|143089923|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||.016
71796004|NCT00962104|143089938|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.78|||<|0.001|TWO_SIDED|95.0|-7.66|-3.91||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline CAARS-Inv:SV 18-Item Total ADHD Symptom score .|ANCOVA|||||-3.91|-7.66|<0.001
71796005|NCT00962104|143089939|SUPERIORITY_OR_OTHER||Slope|4.76|||<|0.001|TWO_SIDED|95.0|1.97|7.56||First gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline AAQoL total score.||||7.56|1.97|<0.001
71796006|NCT00962104|143089940|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.82||||0.289|TWO_SIDED|95.0|-5.2|1.56||Second gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|ANCOVA|Least Squares Mean difference between 2 treatment groups from Type III sum of squares analysis of covariance model:Change=treatment+country+baseline.||||1.56|-5.20|0.289
71796007|NCT00962104|143089941|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.13|-4.22|||Mixed Models Analysis|||||-4.22|-8.13|<0.001
71796008|NCT00962104|143089942|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.18|||<|0.001|TWO_SIDED|95.0|-8.21|-4.14|||Mixed Models Analysis|||||-4.14|-8.21|<0.001
71796009|NCT00962104|143089943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.59||||0.001|TWO_SIDED|95.0|-5.73|-1.45||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-1.45|-5.73|0.001
71796010|NCT00962104|143089943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.29|||<|0.001|TWO_SIDED|95.0|-9.28|-3.31||This is the p-value for the Raw MI score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-3.31|-9.28|<0.001
71796011|NCT00962104|143089943|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.76|||<|0.001|TWO_SIDED|95.0|-14.75|-4.78||This is the p-value for the Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-4.78|-14.75|<0.001
71796012|NCT00962104|143089944|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.93||||0.092|TWO_SIDED|95.0|-4.18|0.32||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.32|-4.18|0.092
71796013|NCT00962104|143089944|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.62||||0.272|TWO_SIDED|95.0|-4.52|1.28||This is the p-value for the Raw MI Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.28|-4.52|0.272
71796014|NCT00962104|143089944|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.55||||0.153|TWO_SIDED|95.0|-8.43|1.32||This is the p-value for the Raw Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||1.32|-8.43|0.153
71796015|NCT00962104|143089945|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.67|-0.27||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||-0.27|-0.67|<0.001
71840144|NCT05139810|143189118|SUPERIORITY||Odds Ratio (OR)|14.8|||<|0.001|TWO_SIDED|95.0|3.15|69.41|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 50% Reduction||69.41|3.15|<0.001
71840145|NCT05139810|143189118|SUPERIORITY||Odds Ratio (OR)|34.74|||<|0.001|TWO_SIDED|95.0|7.32|164.87|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||164.87|7.32|<0.001
71840146|NCT05139810|143189118|SUPERIORITY||Odds Ratio (OR)|9.17|||=|0.004|TWO_SIDED|95.0|2.05|41.09|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 70% Reduction||41.09|2.05|=0.004
71840147|NCT05139810|143189118|SUPERIORITY||Odds Ratio (OR)|17.04|||<|0.001|TWO_SIDED|95.0|3.36|86.42|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||86.42|3.36|<0.001
71840148|NCT05139810|143189118|SUPERIORITY||Odds Ratio (OR)|8.7|||=|0.014|TWO_SIDED|95.0|1.56|48.52|||Regression, Logistic|p-value was calculated based on logistic regression with baseline and the treatment-by-baseline interaction as a covariate.|The odds ratio and its 95% confidence interval were calculated based on a logistic regression with baseline (the time-normalized run-in period attack rate) and the treatment-by-baseline interaction as a covariate.|≥ 90% Reduction||48.52|1.56|=0.014
71840149|NCT05139810|143189119|SUPERIORITY||IC HAE attack rate ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.03|0.234|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.234|0.030|<0.001
71840150|NCT05139810|143189119|SUPERIORITY||IC HAE attack rate ratio|0.33|||=|0.004|TWO_SIDED|95.0|0.155|0.706|||Poisson regression model||Model adjusted rate ratio from Poisson regression model.|The Poisson regression model includes treatment groups, baseline (the run-in period HAE attack rate), the treatment-by-baseline interaction as a covariate, and the logarithm of time in every-4-week that each participant was observed from Week 5 to Week 25 used as an offset variable. Pearson chi-square scaling of standard errors was used in the Poisson regression model to account for potential over dispersion.||0.706|0.155|=0.004
71840151|NCT05139810|143189121|SUPERIORITY||Treatment difference|-18.56|||<|0.001|TWO_SIDED|95.0|-27.673|-9.454|||Mixed model with repeated measures(MMRM)|||||-9.454|-27.673|<0.001
71758480|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.53|||<|0.0001|TWO_SIDED|95.0|0.33|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.73|0.33|<0.0001
71840152|NCT05139810|143189121|SUPERIORITY||Treatment difference|-13.65|||=|0.01|TWO_SIDED|95.0|-24.024|-3.286|||MMRM|||||-3.286|-24.024|=0.010
71840153|NCT03084536|143189154|SUPERIORITY|||||||0.68|||||||Kruskal-Wallis|||||||0.68
71840154|NCT03084536|143189155|SUPERIORITY|||||||0.67|||||||Kruskal-Wallis|||||||0.67
71840155|NCT03084536|143189156|SUPERIORITY|||||||0.53|||||||Kruskal-Wallis|||||||0.53
71840156|NCT03084536|143189157|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.44
71840157|NCT03084536|143189158|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
71840158|NCT04285515|143189191|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-7.6|-3.84|||Mixed Effects Model for Repeated Measure|||||-3.84|-7.60|<0.0001
71840159|NCT04285515|143189192|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.33|<|0.0001|TWO_SIDED|95.0|-8.29|-3.05|||Mixed Effects Model for Repeated Measure|||||-3.05|-8.29|<0.0001
71840160|NCT04285515|143189193|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.35|<|0.0001|TWO_SIDED|95.0|-8.61|-3.29|||Mixed Effects Model for Repeated Measure|||||-3.29|-8.61|<0.0001
71840161|NCT04285515|143189194|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-7.25|-3.88|||Mixed Effects Model for Repeated Measure|||||-3.88|-7.25|<0.0001
71840162|NCT04285515|143189195|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.81|-0.39|||Mixed Effects Model of Repeated Measure|||||-0.39|-0.81|<0.0001
71840163|NCT04285515|143189196|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.91|-0.31|||Mixed Effects Model for Repeated Measure|||||-0.31|-0.91|<0.0001
71840164|NCT04285515|143189197|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.89|-0.27|||Mixed Effects Model for Repeated Measure|||||-0.27|-0.89|0.0003
71840165|NCT04285515|143189198|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.82|-0.44|||Mixed Effects Model for Repeated Measure|||||-0.44|-0.82|<0.0001
71840166|NCT04753697|143189246|SUPERIORITY||Difference in Least Square Mean|-1.91|STANDARD_ERROR_OF_MEAN|0.544||0.0005|TWO_SIDED|95.0|-2.97|-0.84|||ANCOVA|||||-0.84|-2.97|0.0005
71796016|NCT00962104|143089946|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical significance was assessed using an analysis of variance (ANOVA) with term for treatment and country.|ANOVA|||||||<0.001
71796017|NCT00962104|143089947|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.869|TWO_SIDED|95.0|-0.71|0.6||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.60|-0.71|0.869
71796018|NCT00962104|143089948|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05||||0.87|TWO_SIDED|95.0|-0.59|0.5||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA|||||0.50|-0.59|0.870
71796019|NCT01113879|143089952|OTHER||||||<|0.001|TWO_SIDED|85.0|||||Weighted Tau U|||Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).||||< 0.001
71796020|NCT02196324|143089959|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.34|=|0.0111|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||||-0.2|-1.5|= 0.0111
71796021|NCT02196324|143089960|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.43|=|0.0248|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||||-0.1|-1.8|= 0.0248
71796022|NCT02196324|143089961|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.47||0.0005|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|0.0005
71796023|NCT02196324|143089967|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.4|0.0||||||Week 2||-0.0|-1.4|
71840167|NCT04753697|143189247|SUPERIORITY||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|20.6|32.2|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||32.2|20.6|<0.0001
71796024|NCT02196324|143089967|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.7|-0.1||||||Week 4||-0.1|-1.7|
71796025|NCT02196324|143089967|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0175|TWO_SIDED|95.0|-2.0|-0.2||p-value assume equal variance|t-test, 2 sided|||Week 8||-0.2|-2.0|0.0175
71796026|NCT02196324|143089968|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-3.1|1.6||||||Week 2||1.6|-3.1|
71796027|NCT02196324|143089968|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.7|2.3||||||Week 4||2.3|-2.7|
71840168|NCT04753697|143189248|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|18.4|||<|0.0001|TWO_SIDED|95.0|11.3|25.5|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||25.5|11.3|<0.0001
71840169|NCT04753697|143189248|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI(%)|17.0|||<|0.0001|TWO_SIDED|95.0|10.1|24.0||Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.|Cochran-Mantel-Haenszel|||||24.0|10.1|<0.0001
71840170|NCT04753697|143189249|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|40.0|||<|0.0001|TWO_SIDED|95.0|33.3|46.7|||Cochran-Mantel-Haenszel|Imputed data is used in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status||||46.7|33.3|<0.0001
71840171|NCT04753697|143189250|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|25.7|||<|0.0001|TWO_SIDED|95.0|17.8|33.6|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||33.6|17.8|<0.0001
71796028|NCT02196324|143089968|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-3.6|2.1||||||Week 8||2.1|-3.6|
71796029|NCT02196324|143089969|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||||||Week 2||0.1|-0.4|
71796030|NCT02196324|143089969|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.4|0.2||||||Week 4||0.2|-0.4|
71796031|NCT02196324|143089969|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 8||0.1|-0.6|
71796032|NCT02196324|143089970|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.0625|TWO_SIDED|95.0|-0.02|0.72||p-value assume equal variance.|t-test, 2 sided|||||0.72|-0.02|0.0625
71796033|NCT00692770|143089975|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||=|0.258329|TWO_SIDED|95.0|0.78|1.134||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.134|0.78|=0.258329
71796034|NCT00692770|143089976|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.891|||=|0.121383|TWO_SIDED|95.0|0.735|1.081||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.081|0.735|=0.121383
71796035|NCT00692770|143089977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.995|||=|0.484742|TWO_SIDED|95.0|0.761|1.3||One-sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank|||||1.3|0.761|=0.484742
71796036|NCT00692770|143089978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||<|0.0001|TWO_SIDED|95.0|0.025|0.052|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D index score. Statistical tests were performed with a 2 sided type I error of 5%.||0.052|0.025|<0.0001
71796037|NCT00692770|143089979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.978|||<|0.0001|TWO_SIDED|95.0|1.797|4.159|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D VAS score. Statistical tests were performed with a 2 sided type I error of 5%.||4.159|1.797|<0.0001
71796038|NCT00692770|143089980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.5|6.7|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-HEP score. Statistical tests were performed with a 2 sided type I error of 5%.||6.7|3.5|<0.0001
71796039|NCT00692770|143089981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.4|3.6|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-G score. Statistical tests were performed with a 2 sided type I error of 5%.||3.6|1.4|<0.0001
71796040|NCT00692770|143089982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.562|||||TWO_SIDED|95.0|1.241|1.965|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||1.965|1.241|
71796041|NCT00692770|143089983|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.747|||||TWO_SIDED|95.0|1.407|2.17|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.170|1.407|
71796042|NCT00692770|143089984|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.56|||||TWO_SIDED|95.0|1.206|2.018|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.|||2.018|1.206|
71796043|NCT03865329|143090013|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71796044|NCT03865329|143090014|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71796045|NCT03865329|143090016|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
71796046|NCT03865329|143090017|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71796047|NCT00526058|143090019|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.||||||0.005|TWO_SIDED|90.0|||||ANOVA|||||||0.005
71796048|NCT01714310|143090025|SUPERIORITY|||||||0.58||||||Group: F=.31, df=1/140|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.58
71796049|NCT01714310|143090025|SUPERIORITY|||||||0.85||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.03, df=1/140||||||.85
71796050|NCT01714310|143090025|SUPERIORITY|||||||0.26||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=1.28, df=1/140||||||.26
71796051|NCT01714310|143090026|SUPERIORITY|||||||0.97||||||Group: F=0.00, df=1/44|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.97
71796052|NCT01714310|143090026|SUPERIORITY||||||<|0.0002||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=136.22, df=1/44||||||<.0002
71796053|NCT01714310|143090026|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=64.90, df=1/44||||||<.0001
71796054|NCT01714310|143090027|SUPERIORITY||||||<|0.0001||||||Time: F=41.85, df=1/89, p\<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
71796055|NCT01714310|143090028|SUPERIORITY||||||<|0.0001||||||Time: F=26.65, df=1/92, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
71796056|NCT01714310|143090029|SUPERIORITY||||||<|0.0001||||||Time: F=40.35, df=1/89, p \< .0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
71796057|NCT01714310|143090030|SUPERIORITY||||||<|0.0001||||||Time: F=26.36, df=1/29, p \<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.||||||<0.0001
71796058|NCT01714310|143090031|SUPERIORITY|||||||0.44||||||Group: F=.60, df=1/157|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.44
71796059|NCT01714310|143090031|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=22.39, df=1/157||||||<.0001
71796060|NCT01714310|143090031|SUPERIORITY|||||||0.04||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=4.40, df=1/157||||||.04
71796061|NCT01714310|143090032|SUPERIORITY|||||||0.05||||||Group: F=3.81, df=1/145|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||No significant group\*time interactions. Group trend likely due to baseline differences.|||.05
71796062|NCT01714310|143090032|SUPERIORITY|||||||0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Tie: F=15.28, df=1/145||||||.0001
71796063|NCT01714310|143090032|SUPERIORITY|||||||0.02||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=5.42, df=1/145||||||.02
71796064|NCT01714310|143090033|SUPERIORITY|||||||0.76|||||||Chi-squared|Chi Square = .10, df=1, p=.76||||||.76
71796065|NCT01714310|143090034|SUPERIORITY|||||||0.38||||||Group: F=.78, df=1/220|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).||||||.38
71796066|NCT01714310|143090034|SUPERIORITY|||||||0.42||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.66, df=1/220||||||.42
71796067|NCT01714310|143090034|SUPERIORITY|||||||0.13||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.66, df=1/220||||||.13
71796068|NCT01714310|143090035|SUPERIORITY|||||||0.21||||||Group: F=1.56, df=1/222|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.21
71673610|NCT00507455|142865357|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|2.18|||||TWO_SIDED|95.0|0.98|3.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.||3.37|0.98|
71673611|NCT02019264|142865373|NON_INFERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than 1.4 (the non-inferiority margin).|Hazard Ratio (HR)|1.005||||0.0001|TWO_SIDED|97.5|0.842|1.198|||Primary Analytic Method|||||1.198|0.842|0.0001
71673612|NCT02019264|142865374|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.969||||0.5464|TWO_SIDED|95.0|0.873|1.074|||Primary Analytic Method|||||1.074|0.873|0.5464
71673613|NCT02019264|142865375|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment as covariate.|Hazard Ratio (HR)|0.807||||0.038|TWO_SIDED|95.0|0.659|0.988|||Primary Analytic Method|||||0.988|0.659|0.0380
71796069|NCT01714310|143090035|SUPERIORITY||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=63.11, df=1/222||||||<.0001
71796070|NCT01714310|143090035|SUPERIORITY|||||||0.0004||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=12.86, df=1/222||||||.0004
71796071|NCT01714310|143090036|SUPERIORITY|||||||0.02||||||Group: F=5.42, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.02
71796072|NCT01714310|143090036|SUPERIORITY|||||||0.18||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.77, df=1/223||||||.18
71796073|NCT01714310|143090036|SUPERIORITY|||||||0.49||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.47, df=1/223||||||.49
71796074|NCT01714310|143090037|SUPERIORITY|||||||0.9||||||Group: F=.02, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.90
71796075|NCT01714310|143090037|SUPERIORITY|||||||0.21||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.60, df=1/223||||||.21
71796076|NCT01714310|143090037|SUPERIORITY|||||||0.73||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.12, df=1/223||||||.73
71796077|NCT01714310|143090038|SUPERIORITY|||||||0.15||||||Group: F=2.05, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).||||||.15
71796078|NCT01714310|143090038|SUPERIORITY|||||||0.59||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.29, df=1/223||||||.59
71796079|NCT01714310|143090038|SUPERIORITY|||||||0.14||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=2.15, df=1/223||||||.14
71796080|NCT02822508|143090042|SUPERIORITY|||||||0.034|||||||Cochran-Mantel-Haenszel|||||||0.034
71796081|NCT00654381|143090043|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.04|-0.7|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-0.7|-1.04|<0.0001
71796082|NCT00654381|143090043|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.05|-0.71|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-0.71|-1.05|<0.0001
71796083|NCT00654381|143090044|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.09||0.0003|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||||-0.15|-0.49|0.0003
71796084|NCT00654381|143090044|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-0.21|-0.56|<0.0001
71796085|NCT00654381|143090048|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-25.4|-14.0|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12||-14.0|-25.4|<0.0001
71796086|NCT00654381|143090048|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-26.2|-14.7|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12||-14.7|-26.2|<0.0001
71796087|NCT00654381|143090049|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|3.1||0.0239|TWO_SIDED|95.0|-13.0|-0.9|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs Voglibose at week 26||-0.9|-13.0|0.0239
71840172|NCT04753697|143189250|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|27.7|||<|0.0001|TWO_SIDED|95.0|19.7|35.7|||Cochran-Mantel-Haenszel|Imputed data is used for all in CMH test, which is stratified by Steroid Inadequate Responder/Intolerant status.||||35.7|19.7|<0.0001
71840173|NCT04753697|143189251|SUPERIORITY||DIFFERENCE IN LSM|-2.26|STANDARD_ERROR_OF_MEAN|0.655||0.0006|TWO_SIDED|95.0|-3.55|-0.98|||ANCOVA|||||-0.98|-3.55|0.0006
71840174|NCT04753697|143189251|SUPERIORITY||DIFFERENCE IN LSM|-2.49|STANDARD_ERROR_OF_MEAN|0.657||0.0002||95.0|-3.78|-1.2|||ANCOVA|||||-1.20|-3.78|0.0002
71673614|NCT02019264|142865376|NON_INFERIORITY|Myocardial Infarction: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|0.991||||0.0001|TWO_SIDED|97.5|0.824|1.191|||Primary Analytic Method|||||1.191|0.824|0.0001
71673615|NCT02019264|142865376|NON_INFERIORITY|Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% CI refers to the upper limit of the displayed 2-sided 95% CI.|Hazard Ratio (HR)|0.856||||0.0005|TWO_SIDED|97.5|0.639|1.145|||Primary Analytic Method|||||1.145|0.639|0.0005
71673616|NCT02019264|142865376|NON_INFERIORITY|Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|1.045||||0.0262|TWO_SIDED|97.5|0.778|1.404|||Primary Analytic Method|||||1.404|0.778|0.0262
71673617|NCT02019264|142865376|SUPERIORITY|Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.163||||0.3243|TWO_SIDED|95.0|0.861|1.571|||Primary Analytic Method|||||1.571|0.861|0.3243
71673618|NCT02019264|142865376|SUPERIORITY|Heart Failure: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.952||||0.6758|TWO_SIDED|95.0|0.757|1.197|||Primary Analytic Method|||||1.197|0.757|0.6758
71673619|NCT02019264|142865376|SUPERIORITY|Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.981||||0.7817|TWO_SIDED|95.0|0.856|1.125|||Primary Analytic Method|||||1.125|0.856|0.7817
71673620|NCT02019264|142865377|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.082||||0.4212|TWO_SIDED|95.0|0.893|1.31|||Primary Analytic Method|||||1.310|0.893|0.4212
71673621|NCT02019264|142865378|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|1.124||||0.181|TWO_SIDED|95.0|0.947|1.333|||Primary Analytic Method|||||1.333|0.947|0.1810
71673622|NCT02019264|142865379|SUPERIORITY|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.773||||0.0116|TWO_SIDED|95.0|0.633|0.944|||Primary Analytic Method|||||0.944|0.633|0.0116
71673623|NCT02019264|142865380|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.39|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.35||P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.|ANCOVA|||||-0.35|-0.43|<0.0001
71673624|NCT02019264|142865381|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.869||||0.0054|TWO_SIDED|95.0|0.787|0.959|||Primary Analytic Method|||||0.959|0.787|0.0054
71673625|NCT02019264|142865382|SUPERIORITY|Hazard ratio on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.904||||0.3661|TWO_SIDED|95.0|0.727|1.125|||Primary Analytic Method|||||1.125|0.727|0.3661
71673626|NCT02019264|142865383|SUPERIORITY||Hazard Ratio (HR)|0.855||||0.0082|TWO_SIDED|95.0|0.762|0.96|||Primary Analytic Method|||||0.960|0.762|0.0082
71673627|NCT02019264|142865384|SUPERIORITY|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.182||||0.0297|TWO_SIDED|95.0|1.017|1.375|||Primary Analytic Method|||||1.375|1.017|0.0297
71673628|NCT02019264|142865385|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5015|TWO_SIDED|95.0|0.69|2.11||P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.|Regression, Logistic|||||2.11|0.69|0.5015
71673629|NCT02019264|142865386|SUPERIORITY||Odds Ratio (OR)|1.31||||0.7249|TWO_SIDED|95.0|0.29|5.98||P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.|Regression, Logistic|||||5.98|0.29|0.7249
71673630|NCT02019264|142865387|SUPERIORITY||Least square (LS) Mean Difference (Net)|-0.9036||||0.2976|TWO_SIDED|95.0|-1.2908|-0.5163||P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.|Mixed-effects model|||||-0.5163|-1.2908|0.2976
71673631|NCT04994691|142865402|SUPERIORITY||Risk Ratio (RR)|1.92||||0|TWO_SIDED|95.0|1.38|2.6|||Regression, Logistic||Standard Message vs. No Message|||2.60|1.38|0.000
71673632|NCT04994691|142865402|SUPERIORITY||Risk Ratio (RR)|1.52||||0.023|TWO_SIDED|95.0|1.06|2.13|||Regression, Logistic||Tailored Message vs. No Message|||2.13|1.06|0.023
71673633|NCT04994691|142865402|SUPERIORITY||Risk Ratio (RR)|1.26||||0.124|TWO_SIDED|95.0|0.94|1.66|||Regression, Logistic||Standard Message vs. Tailored Message|||1.66|0.94|0.124
71840175|NCT04753697|143189252|SUPERIORITY||DIFFERENCE IN LSM|-4.0|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-4.8|-3.2|||ANCOVA|||||-3.2|-4.8|<0.0001
71673634|NCT04994691|142865403|SUPERIORITY||Risk Ratio (RR)|1.97||||0.001|TWO_SIDED|95.0|1.32|2.84|||Regression, Logistic||Standard Message vs. No Message|||2.84|1.32|0.001
71673635|NCT04994691|142865403|SUPERIORITY||Risk Ratio (RR)|1.57||||0.04|TWO_SIDED|95.0|1.02|2.34|||Regression, Logistic||Tailored Message vs. No Message|||2.34|1.02|0.040
71840176|NCT04753697|143189253|SUPERIORITY||DIFFERENCE IN LSM|-3.5|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.5|-2.4|||ANCOVA|||||-2.4|-4.5|<0.0001
71673636|NCT04994691|142865403|SUPERIORITY||Risk Ratio (RR)|1.26||||0.202|TWO_SIDED|95.0|0.88|1.74|||Regression, Logistic||Standard Message vs. Tailored Message|||1.74|0.88|0.202
71673637|NCT01737710|142865408|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.082|TWO_SIDED|95.0|0.92|3.55||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||3.55|0.92|0.082
71673638|NCT01737710|142865409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.801|TWO_SIDED|95.0|0.26|2.56||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups|Fisher Exact|||||2.56|0.26|0.801
71673639|NCT01737710|142865410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.177|TWO_SIDED|95.0|0.75|5.71||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||5.71|0.75|0.177
71840177|NCT04753697|143189253|SUPERIORITY||DIFFERENCE IN LSM|-3.1|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|95.0|-4.1|-2.1|||ANCOVA|||||-2.1|-4.1|<0.0001
71673640|NCT01737710|142865411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25||||0.092|TWO_SIDED|95.0|0.96|1.61||Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.|ANCOVA|||||1.61|0.96|0.092
71673641|NCT01737710|142865412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.103|TWO_SIDED|95.0|0.32|1.11||Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.|ANCOVA|||||1.11|0.32|0.103
71673642|NCT01737710|142865413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04||||0.895|TWO_SIDED|95.0|0.6|1.8||Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.|ANCOVA|||||1.80|0.60|0.895
71673643|NCT01737710|142865414|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03|||>|0.999|TWO_SIDED|95.0|0.54|1.97||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.97|0.54|>0.999
71796088|NCT00654381|143090049|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|3.1||0.0015|TWO_SIDED|95.0|-15.8|-3.8|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26||-3.8|-15.8|0.0015
71796089|NCT04164901|143090066|SUPERIORITY||Cox Proportional Hazard|0.39|||<|1e-07|TWO_SIDED|95.0|0.27|0.56|||Kaplan-Meier|||||0.56|0.27|<0.0000001
71796090|NCT04164901|143090069|SUPERIORITY||Odds Ratio (OR)|4.88||||0.003|TWO_SIDED|95.0|1.56|15.25|||Cochran-Mantel-Haenszel||Odds ratio was calculated with placebo as the control (denominator).|||15.25|1.56|0.003
71796091|NCT04164901|143090076|SUPERIORITY||Cox Proportional Hazard|0.35||||2.4e-07|TWO_SIDED|95.0|0.23|0.54|||Kaplan-Meier|||||0.54|0.23|0.00000024
71796092|NCT04998136|143090079|SUPERIORITY||Treatment difference|-12.99|||<|0.0001|TWO_SIDED|95.0|-15.28|-10.7|||ANCOVA|||Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period.||-10.70|-15.28|<0.0001
71796093|NCT04998136|143090080|SUPERIORITY||Treatment Difference|-13.4|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.11|||MMRM|||Hypothetical Estimand. The primary endpoint was analysed using mixed model for repeated measurements (MMRM). All responses prior to first discontinuation of treatment (or dose reduction, or initiation of other anti-obesity medication or bariatric surgery) were included in MMRM with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||-11.11|-15.70|<0.0001
71796094|NCT04998136|143090081|SUPERIORITY||Odds Ratio (OR)|88.87|||<|0.0001|TWO_SIDED|95.0|21.96|359.61|||Regression, Logistic|||Treatment policy estimand. The primary endpoint was analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial period.||359.61|21.96|<0.0001
71796095|NCT04998136|143090082|SUPERIORITY||Odds Ratio (OR)|253.47|||<|0.0001|TWO_SIDED|95.0|38.41|1672.57|||Regression, Logistic|||Hypothetical estimand. MMRM was used with randomized treatment as factor and baseline body weight as covariate. The MMRM was performed on body weight (kg) and individual missing week 44 responses were predicted from the MMRM, each participant was then classified for body weight loss \>= 5% and analysed using a binary logistic regression model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from on-treatment observation period.||1672.57|38.41|<0.0001
71796096|NCT03917420|143090257|OTHER|Correlation|Spearman's Rho|-0.455|||||TWO_SIDED|||||||||||||
71796097|NCT03917420|143090258|OTHER|Correlation|Spearman's Rho|0.152|||||TWO_SIDED|||||||||||||
71796098|NCT03917420|143090259|OTHER|Correlation|Spearman's Rho|0.564|||||TWO_SIDED|||||||||||||
71796099|NCT03917420|143090260|OTHER|Correlation|Spearman's Rho|0.285|||||TWO_SIDED|||||||||||||
71796100|NCT06049043|143090268|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|0.04||0.26|TWO_SIDED|95.0|-14.02|3.84|||t-test, 2 sided|||||3.84|-14.02|0.26
71796101|NCT06049043|143090269|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|4.84||0.44|TWO_SIDED|95.0|-13.43|5.85|||t-test, 2 sided|||||5.85|-13.43|0.44
71796102|NCT06049043|143090270|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.44||0.62|TWO_SIDED|95.0|-0.66|1.1|||t-test, 2 sided|||||1.10|-0.66|0.62
71796103|NCT06049043|143090271|SUPERIORITY||Mean Difference (Final Values)|6.34|STANDARD_ERROR_OF_MEAN|0.04||0.16|TWO_SIDED|95.0|-2.5|15.18|||t-test, 2 sided|||||15.18|-2.50|0.16
71796104|NCT06049043|143090271|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.28|TWO_SIDED|95.0|-0.13|0.04|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.04|-0.13|0.28
71796105|NCT06049043|143090272|SUPERIORITY||Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|4.67||0.67|TWO_SIDED|95.0|-7.31|11.28|||t-test, 2 sided|||||11.28|-7.31|0.67
71796106|NCT06049043|143090272|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED|95.0|-0.12|0.08|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.08|-0.12|0.69
71796107|NCT06049043|143090273|SUPERIORITY||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.32||0.09|TWO_SIDED|95.0|-0.09|1.18|||t-test, 2 sided|||||1.18|-0.09|0.09
71840178|NCT04753697|143189254|SUPERIORITY||DIFFERENCE IN LSM|-22.51|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|95.0|-25.5|-19.51|||ANCOVA|||||-19.51|-25.50|<0.0001
71796108|NCT06049043|143090273|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|0.36||0.71|TWO_SIDED|95.0|-0.86|0.59|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.59|-0.86|0.71
71796109|NCT06049043|143090274|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.08|TWO_SIDED|95.0|-0.07|1.27|||t-test, 2 sided|||||1.27|-0.07|0.08
71796110|NCT06049043|143090274|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.42||0.39|TWO_SIDED|95.0|-1.21|0.48|||Regression, Linear|Controlled for participant characteristics at baseline.||||0.48|-1.21|0.39
71796111|NCT06049043|143090276|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.89|TWO_SIDED|95.0|-0.95|0.82|||t-test, 2 sided|||||0.82|-0.95|0.89
71796112|NCT02739269|143090282|SUPERIORITY|||||||0.479|||||||Chi-squared|||||||0.479
71796113|NCT02739269|143090283|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71840179|NCT04753697|143189255|SUPERIORITY||DIFFERENCE IN LSM|-18.13|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-21.85|-14.4|||ANCOVA|||||-14.40|-21.85|<0.0001
71840180|NCT04753697|143189255|SUPERIORITY||DIFFERENCE IN LSM|-19.22|STANDARD_ERROR_OF_MEAN|1.88|<|0.0001|TWO_SIDED|95.0|-22.9|-15.53|||ANCOVA|||||-15.53|-22.90|<0.0001
71796114|NCT00811577|143090301|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.57
71796115|NCT00811577|143090301|SUPERIORITY_OR_OTHER|||||||0.56||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.56
71796116|NCT00811577|143090301|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.61
71796117|NCT00811577|143090301|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.||||0.80
71796118|NCT00811577|143090302|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.47
71796119|NCT00811577|143090302|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.080
71796120|NCT00811577|143090302|SUPERIORITY_OR_OTHER|||||||0.96||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.96
71796121|NCT00811577|143090302|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.||||0.22
71796122|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.87
71796123|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.15
71796124|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.77
71796125|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.75||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.75
71840181|NCT04753697|143189256|SUPERIORITY||DIFFERENCE IN LSM|-25.4|STANDARD_ERROR_OF_MEAN|1.793|<|0.0001|TWO_SIDED|95.0|-28.92|-21.89|||ANCOVA|||||-21.89|-28.92|<0.0001
71840182|NCT04753697|143189257|SUPERIORITY||DIFFERENCE IN LSM|-20.82|STANDARD_ERROR_OF_MEAN|2.229|<|0.0001|TWO_SIDED|95.0|-25.17|-18.91|||Cochran-Mantel-Haenszel|||||-18.91|-25.17|<0.0001
71840183|NCT04753697|143189257|SUPERIORITY||DIFFERENCE IN LSM|-23.43|STANDARD_ERROR_OF_MEAN|2.222|<|0.0001|TWO_SIDED|95.0|-27.73|-21.56|||ANCOVA|||||-21.56|-27.73|<0.0001
71840184|NCT04753697|143189258|SUPERIORITY||DIFFERENCE IN LSM|-4.1|STANDARD_ERROR_OF_MEAN|1.174||0.0005|TWO_SIDED|95.0|-6.4|-1.8|||ANCOVA|||||-1.80|-6.40|0.0005
71840185|NCT04753697|143189259|SUPERIORITY||DIFFERENCE IN LSM|-4.35|STANDARD_ERROR_OF_MEAN|1.42||0.0022|TWO_SIDED|95.0|-7.14|-1.57|||ANCOVA|||||-1.57|-7.14|0.0022
71840186|NCT04753697|143189259|SUPERIORITY||Difference in LSM|-5.2|STANDARD_ERROR_OF_MEAN|1.425||0.0003|TWO_SIDED|95.0|-8.0|-2.41|||ANCOVA|||||-2.41|-8.00|0.0003
71840187|NCT04753697|143189260|SUPERIORITY||DIFFERENCE IN RESPONSE RATE AFTER MI (%)|16.9||||0.0016|TWO_SIDED|95.0|6.7|27.2|||ANCOVA|||||27.2|6.7|0.0016
71840188|NCT04176601|143189287|SUPERIORITY||Mean Difference (Net)|4.32|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|1.49|7.15||||||||7.15|1.49|
71840189|NCT04176601|143189288|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|1.26|8.15||||||||8.15|1.26|
71840190|NCT04176601|143189289|SUPERIORITY||Mean Difference (Net)|3.68|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|1.59|6.14||||||||6.14|1.59|
71840191|NCT02618577|143189294|SUPERIORITY||adjusted cause-specific hazard ratio|0.81||||0.15|TWO_SIDED|95.0|0.6|1.08|||Cause-spec. Cox Proport. Hazard model|||||1.08|0.6|0.15
71840192|NCT02618577|143189295|SUPERIORITY||adjusted cause-specific hazard ratio|0.79|||||TWO_SIDED|95.0|0.45|1.39||||||||1.39|0.45|
71840193|NCT02618577|143189296|SUPERIORITY||adjusted cause-specific hazard ratio|0.89|||||TWO_SIDED|95.0|0.67|1.18||||||||1.18|0.67|
71673644|NCT01737710|142865415|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.253|TWO_SIDED|95.0|0.09|1.63||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||1.63|0.09|0.253
71673645|NCT01737710|142865416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.218|TWO_SIDED|95.0|0.06|1.58||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||1.58|0.06|0.218
71673646|NCT01737710|142865417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.14|TWO_SIDED|95.0|0.84|2.94||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||2.94|0.84|0.140
71673647|NCT01737710|142865418|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.791|TWO_SIDED|95.0|0.24|2.65||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.65|0.24|0.791
71796126|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.050
71796127|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.83
71796128|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.37
71840194|NCT02618577|143189297|SUPERIORITY||adjusted cause-specific hazard ratio|1.16||||0.28|TWO_SIDED|95.0|0.88|1.53|||Cause-spec. Cox Proport. Hazard model|||||1.53|0.88|0.28
71840195|NCT02618577|143189298|SUPERIORITY||adjusted cause-specific hazard ratio|2.1||||0.002|TWO_SIDED|95.0|1.3|3.38|||Cause-spec. Cox Proport. Hazard model|||||3.38|1.3|0.002
71796129|NCT00811577|143090303|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.43
71840196|NCT02618577|143189299|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L UK Index||0.01|-0.02|
71840197|NCT02618577|143189299|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-1.46|1.38|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|EQ-5D-5L VAS, FU 24months||1.38|-1.46|
71840198|NCT02618577|143189299|SUPERIORITY||Mean Difference (Final Values)|0.27|||||TWO_SIDED|95.0|-0.56|1.09|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|Karnofsky score||1.09|-0.56|
71840199|NCT02618577|143189300|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-1.12|0.87|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q convenience||0.87|-1.12|
71840200|NCT02618577|143189300|SUPERIORITY||Mean Difference (Final Values)|-1.04|||||TWO_SIDED|95.0|-2.6|0.52|||||Estimation Parameter: baseline adjusted trial-group specific effect estimates (mean difference)|PACT-Q satisfaction||0.52|-2.60|
71840201|NCT02618577|143189303|SUPERIORITY||adjusted cause-specific hazard ratio|0.51|||||TWO_SIDED|95.0|0.27|0.96||||||||0.96|0.27|
71840202|NCT02618577|143189304|SUPERIORITY||adjusted cause-specific hazard ratio|0.9|||||TWO_SIDED|95.0|0.62|1.31||||||||1.31|0.62|
71840203|NCT04164888|143189361|SUPERIORITY||Least Square Mean|-84.56|STANDARD_ERROR_OF_MEAN|7.137|<|0.0001|TWO_SIDED|95.0|-98.95|-70.18|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.18|-98.95|<0.0001
71840204|NCT04164888|143189361|SUPERIORITY||Least Square Mean|-80.43|STANDARD_ERROR_OF_MEAN|7.018|<|0.0001|TWO_SIDED|95.0|-94.58|-66.29|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-66.29|-94.58|<0.0001
71840205|NCT04164888|143189361|SUPERIORITY||Least Square Mean|-84.87|STANDARD_ERROR_OF_MEAN|7.009|<|0.0001|TWO_SIDED|95.0|-99.0|-70.75|||ANCOVA|ANCOVA with LOCF||Applying the LOCF method (Last Observation Carried Forward) did not result in any changes at Day 29 or Day 57 due to the lack of missing values and resulted in similar results at Day 85.||-70.75|-99.00|<0.0001
71840206|NCT04164888|143189362|SUPERIORITY||Least Square Mean|-48.03|STANDARD_ERROR_OF_MEAN|7.46|<|0.0001|TWO_SIDED|95.0|-63.06|-32.99|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-32.99|-63.06|<0.0001
71840207|NCT04164888|143189362|SUPERIORITY||Least Square Mean|-49.59|STANDARD_ERROR_OF_MEAN|7.396|<|0.0001|TWO_SIDED|95.0|-64.5|34.69|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||34.69|-64.50|<0.0001
71840208|NCT04164888|143189362|SUPERIORITY||Least Square Mean|-51.99|STANDARD_ERROR_OF_MEAN|7.616|<|0.0001|TWO_SIDED|95.0|-67.34|-36.64|||ANCOVA|ANCOVA with LOCF||Similar changes from baseline were observed for Day 29, Day 57, and Day 85 compared to Day 29, Day 57, and Day 85 LOCF.||-36.64|-67.34|<0.0001
71796130|NCT00811577|143090304|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.16
71796131|NCT00811577|143090304|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.14
71796132|NCT00811577|143090304|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.69
71796133|NCT00811577|143090304|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.89
71796134|NCT00811577|143090304|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.30
71796135|NCT00811577|143090304|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.||||0.46
71796136|NCT00811577|143090305|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.086
71796137|NCT00811577|143090305|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.66
71796138|NCT00811577|143090305|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.069
71796139|NCT00811577|143090305|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.68
71796140|NCT00811577|143090305|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.095
71796141|NCT00811577|143090305|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.||||0.62
71796142|NCT00811577|143090306|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.44
71796143|NCT00811577|143090306|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject's gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.||||0.41
71796144|NCT02641379|143090309|SUPERIORITY_OR_OTHER|||||||0.1002|||||||Chi-squared|||For Genotype I, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.1002
71796145|NCT02641379|143090309|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Chi-squared|||For Genotype I, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0184
71796146|NCT02641379|143090309|SUPERIORITY_OR_OTHER|||||||0.091|||||||Chi-squared|||For Genotype IV, Week 4 response \< 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||0.0910
71796147|NCT02641379|143090309|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||For Genotype IV, Week 4 response \>= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.||||1.0000
71796148|NCT02641379|143090310|SUPERIORITY_OR_OTHER|||||||0.0021||||||The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype I.||||0.0021
71796149|NCT02641379|143090310|SUPERIORITY_OR_OTHER|||||||0.3031||||||The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype IV||||0.3031
71796150|NCT01165138|143090324|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.136||||0.002|TWO_SIDED|95.0|0.051|0.222|||ANCOVA|||||0.222|0.051|0.002
71673648|NCT01737710|142865419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.833|TWO_SIDED|95.0|0.47|2.92||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|Fisher Exact|||||2.92|0.47|0.833
71673649|NCT01737710|142865420|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.378|TWO_SIDED|95.0|0.4|1.38||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact|||||1.38|0.40|0.378
71673650|NCT01737710|142865421|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.783|TWO_SIDED|95.0|0.21|2.62||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact|||||2.62|0.21|0.783
71673651|NCT01737710|142865422|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45||||0.143|TWO_SIDED|95.0|0.13|1.39|||Fisher Exact|Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.||||1.39|0.13|0.143
71673652|NCT00942890|142865452|SUPERIORITY_OR_OTHER||Slope|0.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71673653|NCT00942890|142865458|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
71673654|NCT01814696|142865472|SUPERIORITY_OR_OTHER_LEGACY|||||||0.605||||||a prior threshold p\<0.05|Fisher Exact|||||||0.605
71673655|NCT01814696|142865473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.604|TWO_SIDED||||||Fisher Exact|||Heart failure related ED visits||||0.604
71673656|NCT01814696|142865473|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||Non-heart failure related ED visits||||1.000
71673657|NCT01814696|142865473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||All cause ED visits||||0.677
71673658|NCT01814696|142865474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.341|TWO_SIDED||||||Fisher Exact|||||||0.341
71796151|NCT01165138|143090324|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.087|0.258|||ANCOVA|||||0.258|0.087|<0.001
71796152|NCT01165138|143090324|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.036||||0.405|TWO_SIDED|95.0|-0.048|0.12|||ANCOVA|||||0.120|-0.048|0.405
71796153|NCT01165138|143090325|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.186||||0.003|TWO_SIDED|95.0|0.062|0.31|||ANCOVA|||||0.310|0.062|0.003
71673659|NCT01814696|142865474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042|TWO_SIDED||||||Fisher Exact|||||||0.042
71673660|NCT01814696|142865475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.497
71673661|NCT01814696|142865475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.413
71673662|NCT01814696|142865475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.944|TWO_SIDED||||||Wilcoxon rank-sum test|||Non-heart failure ED visits||||0.944
71673663|NCT01814696|142865476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057|TWO_SIDED||||||Wilcoxon rank-sum test|||All cause||||0.057
71673664|NCT01814696|142865476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Heart failure related||||0.236
71796154|NCT01165138|143090325|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.302|||<|0.001|TWO_SIDED|95.0|0.178|0.426|||ANCOVA|||||0.426|0.178|<0.001
71796155|NCT01165138|143090325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116||||0.06|TWO_SIDED|95.0|-0.005|0.236|||ANCOVA|||||0.236|-0.005|0.060
71796156|NCT04982250|143090342|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-26.0|11.0|||||Risk differences (RD) with 95% confidence intervals (CI) were estimated using regression models with Gaussian distributions, identify links, study group fixed effects, and index peer random effects (to adjust for clustering).|The sample size calculation was based on the primary PrEP initiation outcome at follow-up; 80 clusters (40 per study group) provided 80% power to detect a 17% difference in PrEP initiation between the enhanced (80%) and standard (63%) groups, assuming three referred peers per cluster (75% of those recommended), an intra-cluster correlation coefficient of 0.05, and an alpha level of 0.05.||11|-26|
71796157|NCT04982250|143090347|SUPERIORITY||Risk Difference (RD)|39.0|||||TWO_SIDED|95.0|24.0|54.0||||||||54|24|
71673665|NCT01814696|142865476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.236
71673666|NCT01814696|142865477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Wilcoxon rank-sum test|||All cause||||0.034
71796158|NCT04982250|143090348|SUPERIORITY||Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-10.0|13.0||||||||13|-10|
71673667|NCT01814696|142865477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196|||||||Wilcoxon rank-sum test|||Heart failure related||||0.196
71673668|NCT01814696|142865477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|TWO_SIDED||||||Wilcoxon rank-sum test|||Non heart failure related||||0.210
71673669|NCT01814696|142865478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71673670|NCT00812981|142865496|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio of HI antibodies against the A/Indonesia/05/2005 strain between the two groups (1562902A CP Group over 1562902A NP Group), being below (\<) 2.0.|Adjusted GMT ratio|0.84|||||TWO_SIDED|95.0|0.71|0.99|||ANCOVA|||Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.||0.99|0.71|
71796159|NCT04982250|143090349|SUPERIORITY||Risk Difference (RD)|-19.0|||||TWO_SIDED|95.0|-40.0|2.0||||||||2|-40|
71796160|NCT04982250|143090350|SUPERIORITY||Median Difference (Final Values)|-16.9|||||TWO_SIDED|95.0|-36.3|2.5||||||||2.5|-36.3|
71796161|NCT04982250|143090351|SUPERIORITY||Median Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-0.2|1.1||||||||1.1|-0.2|
71796162|NCT01644175|143090358|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.9|||<|0.0001|TWO_SIDED|95.0|-52.5|-39.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-39.3|-52.5|<0.0001
71796163|NCT01644175|143090359|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.9|||<|0.0001|TWO_SIDED|95.0|-56.2|-43.6||Threshold for significance was ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-43.6|-56.2|<0.0001
71673671|NCT04922255|142865521|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
71796164|NCT01644175|143090360|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.4|||<|0.0001|TWO_SIDED|95.0|-53.6|-41.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.3|-53.6|<0.0001
71796165|NCT01644175|143090361|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.3|-55.3|<0.0001
71796166|NCT01644175|143090362|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-41.3|-30.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.3|-41.3|<0.0001
71796167|NCT01644175|143090363|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.0|-32.0||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.0|-43.0|<0.0001
71796168|NCT01644175|143090364|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-43.5|-31.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.4|-43.5|<0.0001
71796169|NCT01644175|143090365|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.4|||<|0.0001|TWO_SIDED|95.0|-46.4|-34.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.4|-46.4|<0.0001
71796170|NCT01644175|143090366|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.0|||<|0.0001|TWO_SIDED|95.0|-29.3|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-29.3|<0.0001
71796171|NCT01644175|143090367|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-43.7|-32.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.7|-43.7|<0.0001
71796172|NCT01644175|143090368|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.1|||<|0.0001|TWO_SIDED|95.0|-46.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.9|-46.2|<0.0001
71796173|NCT01644175|143090369|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.4|||<|0.0001|TWO_SIDED|95.0|-31.1|-21.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-31.1|<0.0001
71796174|NCT01644175|143090370|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|95.0|-51.6|-34.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.3|-51.6|<0.0001
71796175|NCT01644175|143090371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|38.5|||<|0.0001|TWO_SIDED|95.0|16.5|89.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||89.8|16.5|<0.0001
71673672|NCT04922255|142865522|SUPERIORITY|||||||0.5|||||||Kruskal-Wallis|||||||0.50
71796176|NCT01644175|143090372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|50.0|||<|0.0001|TWO_SIDED|95.0|20.6|121.0||Threshold for significance ≤ 0.05|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||121.0|20.6|<0.0001
71796177|NCT01644175|143090373|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.6|||<|0.0001|TWO_SIDED|95.0|-21.3|-7.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-7.9|-21.3|<0.0001
71796178|NCT01644175|143090374|SUPERIORITY_OR_OTHER||LS Mean Difference|7.3||||0.0001|TWO_SIDED|95.0|3.6|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||11.0|3.6|0.0001
71673673|NCT04922255|142865523|SUPERIORITY|||||||0.3|||||||ANOVA|||||||0.30
71673674|NCT04922255|142865524|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.70
71673675|NCT04922255|142865525|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71673676|NCT02677922|142865528|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0003|TWO_SIDED|95.0|1.99|11.85|||Chi-squared|||||11.85|1.99|0.0003
71796179|NCT01644175|143090375|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8699|TWO_SIDED|95.0|-8.3|7.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.0|-8.3|0.8699
71796180|NCT00828191|143090406|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-2.5||||0.52|TWO_SIDED|95.0|-9.4|4.4|||Fisher Exact|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc\>= Pe + d(-10%) H1 : Pc\< Pe + d(-10%)"||4.4|-9.4|0.52
71796181|NCT00828191|143090407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.48||0.54|TWO_SIDED|95.0|-7.6|4.0|||ANOVA|||||4.0|-7.6|0.54
71796182|NCT00828191|143090408|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.0||||0.62|TWO_SIDED|95.0|-8.8|4.8|||Fisher Exact|||||4.8|-8.8|0.62
71796183|NCT03274986|143090415|SUPERIORITY||Least Squares Mean Difference|-0.164|STANDARD_ERROR_OF_MEAN|0.0168|<|0.001|TWO_SIDED|95.0|-0.197|-0.131||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.131|-0.197|<0.001
71796184|NCT03274986|143090416|NON_INFERIORITY|Non-Inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.0127|||ONE_SIDED|95.0||0.073||The hypothesis test was based on a two-sample t-test, with a type I error rate of 0.05, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.|||0.073||
71796185|NCT03274986|143090417|OTHER||Difference in depth of focus|0.54|||||TWO_SIDED|||||Hypothesis testing was not pre-specified.|||Difference in depth of focus (DFT015 - SN60WF)|||||
71796186|NCT03274986|143090421|SUPERIORITY||Least Squares Mean Difference|-0.156|STANDARD_ERROR_OF_MEAN|0.0206|<|0.001|TWO_SIDED|95.0|-0.197|-0.115||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)|||-0.115|-0.197|<0.001
71796187|NCT03274986|143090422|OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|9.65|27.37|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).|||27.37|9.65|
71796188|NCT01524627|143090438|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
71796189|NCT01524627|143090438|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71796190|NCT00615056|143090444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.273||||0.8268|TWO_SIDED|95.0|0.769|2.108||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.108|0.769|0.8268
71796191|NCT00615056|143090444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.041||||0.5498|TWO_SIDED|95.0|0.553|1.041||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.041|0.553|0.5498
71796192|NCT00615056|143090445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.355||||0.8828|TWO_SIDED|95.0|0.82|2.238||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||2.238|0.820|0.8828
71796193|NCT00615056|143090445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.689||||0.1159|TWO_SIDED|95.0|0.373|1.273||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).||1.273|0.373|0.1159
71796194|NCT00615056|143090446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4552|TWO_SIDED|95.0|-15.8|17.7|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||17.7|-15.8|0.4552
71796195|NCT00615056|143090446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5235|TWO_SIDED|95.0|-19.1|18.0|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.||18.0|-19.1|0.5235
71796196|NCT01888497|143090726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|13.82|||<|0.001|TWO_SIDED|95.0|10.85|17.4||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam versus (vs) placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||17.40|10.85|<0.001
71796197|NCT01888497|143090726|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95 percent (%) confidence interval (CI) was 2.4 cm.|Hodges-Lehman estimate|0.55|||||TWO_SIDED|95.0|-0.66|2.33|||||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.33|-0.66|
71796198|NCT01888497|143090726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|1.02||||0.134|TWO_SIDED|95.0|-0.39|2.51||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||2.51|-0.39|0.134
71796199|NCT01888497|143090726|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|2.37|||<|0.001|TWO_SIDED|95.0|1.01|3.98||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For primary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||3.98|1.01|<0.001
71673677|NCT02677922|142865531|SUPERIORITY||Cox Proportional Hazard|0.59||||0.1083|TWO_SIDED|95.0|0.3|1.13|||Log Rank|||||1.13|0.30|0.1083
71673678|NCT02677922|142865533|SUPERIORITY||Odds Ratio (OR)|8.65|||<|0.001|TWO_SIDED|95.0|2.74|27.31|||Chi-squared|||||27.31|2.74|<0.001
71673679|NCT02677922|142865534|SUPERIORITY||Odds Ratio (OR)|1.77||||0.1943|TWO_SIDED|95.0|0.74|4.2|||Chi-squared|||||4.20|0.74|0.1943
71673680|NCT02677922|142865537|SUPERIORITY||Cox Proportional Hazard|0.99||||0.972|TWO_SIDED|95.0|0.52|1.87|||Log Rank|Unstratified log-rank test|Cox proportional hazards regression model|||1.87|0.52|0.9720
71673681|NCT02677922|142865538|OTHER|Confidence interval of difference|Difference|2.6|||||TWO_SIDED|95.0|-17.3|22.5|||||The CI for the difference was derived using Greenwood's variance estimate.|||22.5|-17.3|
71673682|NCT04205643|142865563|SUPERIORITY||Difference estimated using CMH weights|21.1|||<|0.0001|TWO_SIDED|95.0|11.8|29.3||If the primary endpoint is significant, a fixed sequence procedure was employed to control the overall type I error rate of the key secondary endpoints.|Cochran-Mantel-Haenszel|Stratified by Previous biologic agent and/or JAK inhibitors exposure, Use of oral corticosteroids treatment at Week 0, Clinical remission at Week 10.|The 95% stratified Newcombe CI with CMH weights|||29.3|11.8|<0.0001
71673683|NCT00961350|142865602|SUPERIORITY_OR_OTHER||Proportions|3.8||||0.02||95.0|1.8|6.8|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||6.8|1.8|0.020
71840209|NCT03221426|143189366|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.01501|TWO_SIDED|95.0|0.67|0.98||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.98|0.67|0.01501
71673684|NCT00961350|142865603|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
71673685|NCT00961350|142865604|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71673686|NCT00961350|142865605|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||0.002
71673687|NCT00961350|142865606|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71673688|NCT01022307|142865615|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis showed that the effect size was small, with a 50% chance of detecting a p \< 0.05 effect requiring 247 subjects.|||||<|0.04|TWO_SIDED||||||F-test|Greenhouse Geisser correction.||F-test evaluating effects of Group||||< 0.04
71673689|NCT04850989|142865667|SUPERIORITY||Mean Difference (Net)|-5.14|STANDARD_DEVIATION|0.49|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71673690|NCT04850989|142865668|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_DEVIATION|-1.23|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71673691|NCT04850989|142865669|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71673692|NCT04850989|142865670|SUPERIORITY||Mean Difference (Net)|-8.08|STANDARD_DEVIATION|1.91|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71673693|NCT04850989|142865671|SUPERIORITY||Mean Difference (Net)|-3.48|STANDARD_DEVIATION|0.28|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||> 0.05
71893188|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.7046|TWO_SIDED|95.0|-6.44|4.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||4.38|-6.44|0.7046
71673694|NCT05253573|142865707|SUPERIORITY||Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|1.21|2.83||||||The overall number of participants analyzed reflects the cancer survivors and/or independent caregivers. Participants are not represented separately (as cancer survivors or caregivers) for each Arm. This is because the originally proposed statistical data analysis plan did not aim to analyze the data by each group of caregivers versus cancer patients/survivors (because the statistical power would be very low for doing so||2.83|1.21|
71673695|NCT00687271|142865714|OTHER||Difference in Percentage Change|-10.0|||||TWO_SIDED|95.0|-14.6|-5.5|||Longitudinal Data Analysis (LDA) model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-5.5|-14.6|
71673696|NCT00687271|142865714|OTHER||Difference in Percentage Change|-17.9|||||TWO_SIDED|95.0|-23.4|-12.5|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-12.5|-23.4|
71840210|NCT03221426|143189367|SUPERIORITY||Difference in Percentage|11.4|||<|1e-05|TWO_SIDED|95.0|8.0|15.3|||Stratified Miettinen and Nurminen|Based on Miettinen \& Nurminen method stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)||||15.3|8.0|<0.00001
71893189|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.18||||0.2052|TWO_SIDED|95.0|-2.4|10.76|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||10.76|-2.40|0.2052
71893190|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.27||||0.0483|TWO_SIDED|95.0|0.07|16.46|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||16.46|0.07|0.0483
71796200|NCT01888497|143090727|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.36|||<|0.001|TWO_SIDED|95.0|0.26|0.47||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.47|0.26|<0.001
71796201|NCT01888497|143090727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 0.1 m/sec.|Hodges-Lehman estimate|-0.01|||||TWO_SIDED|95.0|-0.07|0.05|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.05|-0.07|
71796202|NCT01888497|143090727|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.07||||0.012|TWO_SIDED|95.0|0.02|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.02|0.012
71796203|NCT01888497|143090727|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|0.06||||0.014|TWO_SIDED|95.0|0.01|0.12||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||0.12|0.01|0.014
71796204|NCT01888497|143090728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|103.25|||<|0.001|TWO_SIDED|95.0|72.0|130.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||130.50|72.00|<0.001
71796205|NCT01888497|143090728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For gabapentin versus placebo comparison, the non-inferiority margin for upper limit of 95% CI was 8 lanes.|Hodges-Lehman estimate|5.0|||||TWO_SIDED|95.0|-4.0|16.5|||||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||16.50|-4.00|
71796206|NCT01888497|143090728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|3.0||||0.213|TWO_SIDED|95.0|-3.0|9.0||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||9.00|-3.00|0.213
71796207|NCT01888497|143090728|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman estimate|11.0||||0.003|TWO_SIDED|95.0|4.0|20.5||Statistical comparison was performed at a two-sided significance level of 0.05.|Wilcoxon Rank Sum test||Hodges-Lehman estimate of treatment difference was reported.|For secondary endpoint sequential order of testing: triazolam vs placebo; gabapentin vs placebo; diphenhydramine citrate vs gabapentin; diphenhydramine citrate vs placebo. If comparison at preceding step was significant, only then subsequent comparisons were considered significant.||20.50|4.00|0.003
71796208|NCT04013191|143090732|OTHER||Point Estimate|0.928|||||TWO_SIDED|90.0|0.725|1.19|||ANOVA|||The analysis of variance (ANOVA) model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.19|0.725|
71796209|NCT04013191|143090733|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.894|1.67|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.67|0.894|
71796210|NCT04013191|143090734|OTHER||Point Estimate|1.22|||||TWO_SIDED|90.0|0.893|1.68|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.68|0.893|
71796211|NCT04013191|143090735|OTHER||Point Estimate|1.02|||||TWO_SIDED|90.0|0.829|1.26|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.26|0.829|
71796212|NCT04013191|143090736|OTHER||Point Estimate|1.18|||||TWO_SIDED|90.0|0.908|1.53|||ANOVA|||The ANOVA model included the fixed effects of age group. The natural logs were taken of the dependent variables and back-transformed after the analysis.||1.53|0.908|
71796213|NCT02431754|143090748|SUPERIORITY_OR_OTHER|||||||0.0937|||||||Normal approximation (Z-test)|||||||0.0937
71796214|NCT02431754|143090749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.1485|TWO_SIDED|95.0|-1.69|0.26|||Mixed Models Analysis|||||0.26|-1.69|0.1485
71796215|NCT02904057|143090755|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Imputed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with confidence interval (CI) was calculated using an exact approach.||98.8|73.4|<0.0001
71796216|NCT02904057|143090755|SUPERIORITY||Difference between proportion|92.1|||<|0.0001|TWO_SIDED|95.0|73.4|98.8|||Fisher Exact|||Observed Data: Difference between proportion of treatment responders and control responders (P\[treatment\] - P\[control\] with CI was calculated using an exact approach.||98.8|73.4|<0.0001
71796217|NCT01275066|143090757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|9.35||0.0174||95.0||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.0174
71673697|NCT00687271|142865717|OTHER||Difference in Percentage Change|-8.6|||||TWO_SIDED|95.0|-12.7|-4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.4|-12.7|
71673698|NCT00687271|142865717|OTHER||Diffence in Percentage Change|-13.9|||||TWO_SIDED|95.0|-18.9|-8.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-8.9|-18.9|
71673699|NCT00687271|142865718|OTHER||Difference in Percentage Change|-7.7|||||TWO_SIDED|95.0|-11.5|-3.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-3.9|-11.5|
71673700|NCT00687271|142865718|OTHER||Difference in Percentage Change|-12.2|||||TWO_SIDED|95.0|-16.8|-7.6|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.6|-16.8|
71673701|NCT00687271|142865719|OTHER||Difference in Percentage Change|-7.4|||||TWO_SIDED|95.0|-10.8|-4.1|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-4.1|-10.8|
71673702|NCT00687271|142865719|OTHER||Difference in Percentage Change|-11.0|||||TWO_SIDED|95.0|-15.1|-7.0|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||-7.0|-15.1|
71673703|NCT00687271|142865720|OTHER||Dfferecne in Percentage Change|-2.4|||||TWO_SIDED|95.0|-6.6|1.8|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||1.8|-6.6|
71673704|NCT00687271|142865720|OTHER||Difference in Percentage Change|-0.7|||||TWO_SIDED|95.0|-5.8|4.4|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||4.4|-5.8|
71673705|NCT00687271|142865721|OTHER||Difference in Percentage Change|-1.0|||||TWO_SIDED|95.0|-7.7|5.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||5.9|-7.7|
71796218|NCT01275066|143090757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|9.29||0.9542||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.||||||0.9542
71796219|NCT01275066|143090758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.66||0.4935||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.4935
71796220|NCT01275066|143090758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.66||0.7783||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.||||||0.7783
71893191|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.93||||0.6832|TWO_SIDED|95.0|-16.41|24.26|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||24.26|-16.41|0.6832
71673706|NCT00687271|142865721|OTHER||Difference in Percentage Change|5.5|||||TWO_SIDED|95.0|-4.6|16.9|||LDA model|LDA model includes factors for time, treatment, baseline triglyceride (TG) category, and time-by treatment interactions.||||16.9|-4.6|
71673707|NCT02314260|142865722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.917|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.854|0.979||Under the nonparametric assumption. P-value \<0.05, means statistical significance|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.979|0.854|0.000
71796221|NCT01275066|143090759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.7|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
71796222|NCT01275066|143090759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|4.19|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p\<0.05 or either of p-values is p\<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.||||||<0.0001
71796223|NCT00934544|143090777|SUPERIORITY_OR_OTHER||Kaplan-Meir estimate|28.1|STANDARD_DEVIATION|22.123|<|0.0001|TWO_SIDED|95.0|21.3|36.6|||Cochran-Mantel-Haenszel|||||36.6|21.3|<0.0001
71796224|NCT01218516|143090788|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.23||||0.3519|TWO_SIDED|80.0|0.92|1.63||Per Primary Analysis Cut-Off Date|Log Rank|||||1.63|0.92|0.3519
71796225|NCT01218516|143090788|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.34||||0.1555|TWO_SIDED|80.0|1.03|1.74||Per Final Analysis Cut-Off Date|Log Rank|||||1.74|1.03|0.1555
71796226|NCT02623803|143090854|SUPERIORITY|||||||0.1459|||||||Wilcoxon (Mann-Whitney)|||||||0.1459
71796227|NCT02623803|143090855|SUPERIORITY|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.2050
71796228|NCT02623803|143090856|SUPERIORITY|||||||0.3989|||||||Wilcoxon (Mann-Whitney)|||||||0.3989
71796229|NCT02623803|143090857|SUPERIORITY|||||||0.5285|||||||Wilcoxon (Mann-Whitney)|||||||0.5285
71796230|NCT02623803|143090858|SUPERIORITY|||||||0.0697|||||||Wilcoxon (Mann-Whitney)|||||||0.0697
71796231|NCT02623803|143090859|SUPERIORITY|||||||0.1029|||||||Wilcoxon (Mann-Whitney)|||||||0.1029
71796232|NCT02623803|143090860|SUPERIORITY|||||||0.3136|||||||Wilcoxon (Mann-Whitney)|||||||0.3136
71796233|NCT02623803|143090861|SUPERIORITY|||||||0.2196|||||||Wilcoxon (Mann-Whitney)|||||||0.2196
71796234|NCT02623803|143090862|SUPERIORITY|||||||0.3057|||||||Wilcoxon (Mann-Whitney)|||||||0.3057
71893192|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.9081|TWO_SIDED|95.0|-18.05|20.05|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||20.05|-18.05|0.9081
71840211|NCT03221426|143189368|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.07503|TWO_SIDED|95.0|0.71|1.06||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||1.06|0.71|0.07503
71840212|NCT03221426|143189373|OTHER||Hazard Ratio (HR)|0.82||||0.04125|TWO_SIDED|95.0|0.65|1.03||One-sided p-value based on log-rank test with stratification|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification|||1.03|0.65|0.04125
71840213|NCT03221426|143189374|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.04493|TWO_SIDED|95.0|0.71|1.03||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia), tumor staging (II vs. III vs. IVa), and chemotherapy backbone (XP/FP vs. FLOT)|||1.03|0.71|0.04493
71840214|NCT03221426|143189375|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.00589|TWO_SIDED|95.0|0.67|0.95||One-sided p-value based on log-rank test stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|Log Rank||Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia vs. Non-Asia) and tumor staging (II vs. III vs. IVa)|||0.95|0.67|0.00589
71840215|NCT03526887|143189451|SUPERIORITY||Median Difference (Net)|9.7||||0.016|TWO_SIDED|95.0|9.4|19.1|||Log Rank|||||19.1|9.4|0.016
71840216|NCT06044090|143189599|SUPERIORITY|||||||0.856|||||||t-test, 2 sided|||||||0.856
71840217|NCT06044090|143189599|SUPERIORITY|||||||0.613|||||||t-test, 2 sided|||||||0.613
71840218|NCT06044090|143189600|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71840219|NCT06044090|143189600|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|||||||0.691
71840220|NCT06044090|143189601|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
71840221|NCT06044090|143189601|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
71840222|NCT05034328|143189608|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71840223|NCT05034328|143189609|SUPERIORITY||Hazard Ratio (HR)|1.063||||0.7026|TWO_SIDED|95.0|0.778|1.451|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treament chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.451|0.778|0.7026
71840224|NCT05034328|143189610|SUPERIORITY||Hazard Ratio (HR)|1.078||||0.6322|TWO_SIDED|95.0|0.792|1.469|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.469|0.792|0.6322
71840225|NCT05034328|143189611|SUPERIORITY||Hazard Ratio (HR)|0.992||||0.9598|TWO_SIDED|95.0|0.726|1.356|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.356|0.726|0.9598
71840226|NCT05034328|143189612|SUPERIORITY||Hazard Ratio (HR)|1.333||||0.1016|TWO_SIDED|95.0|0.945|1.88|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.880|0.945|0.1016
71840227|NCT05034328|143189613|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.3954|TWO_SIDED|95.0|0.83|1.601|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.601|0.830|0.3954
71840228|NCT05034328|143189614|SUPERIORITY||Hazard Ratio (HR)|1.218||||1.218|TWO_SIDED|95.0|0.871|1.703|||Regression, Cox|||For each item 2 to 7 of the WURSS-K questionnaire, the impact of the treatment chosen on the corresponding common cold symptom duration was analyzed by means of Cox model and p-value (Wald) calculated||1.703|0.871|1.218
71840229|NCT05034328|143189615|SUPERIORITY||||||>|0.05|||||||Regression, Logistic|||The impact of the treatment chosen on the risk to develop respiratory complication requiring antibiotic prescription during a 20-day follow-up was analyzed by a multivariate logistic model||||>0.05
71840230|NCT05034328|143189616|SUPERIORITY||Odds Ratio (OR)|0.335||||0.001|TWO_SIDED|95.0|0.174|0.644|||Regression, Logistic|||||0.644|0.174|0.0010
71840231|NCT05445427|143189632|SUPERIORITY|Groups were compared using Wilcoxon rank sum test.||||||0.544|||||||Wilcoxon (Mann-Whitney)|||||||0.544
71840232|NCT05445427|143189633|SUPERIORITY|||||||0.292|||||||ANCOVA|ANCOVA was used with the baseline value used as the covariate.||||||0.292
71840233|NCT02969707|143189634|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|2-sample t-test||Examining the Change in sum of positive z-transformed CC.||||0.035
71840234|NCT02969707|143189634|SUPERIORITY|||||||0.7||||||2-sample t-test|t-test, 2 sided|||Examining the change in sum of all z-transformed CC.||||0.7
71840235|NCT02969707|143189634|SUPERIORITY|2-sample t-test||||||0.11|||||||t-test, 2 sided|||Examining the change in sum of negative z-transformed CC.||||0.11
71840236|NCT02969707|143189634|SUPERIORITY||Mean Difference (Net)|61.98||||0.008|TWO_SIDED||||||t-test, 2 sided|One sample(paired) t-test||Examining the change in positive functional connectivity between the L-DLPFC and the dACC within the active group from pre to post TMS.||||0.008
71840237|NCT02969707|143189636|OTHER||Mann-Whitney U statistic|601.0||||0.046|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||0.046
71840238|NCT02969707|143189636|OTHER||Cohen's R|0.25|||||TWO_SIDED||||||||Estimate of effect size|Non-parametric analysis, comparison of change (post-treatment minus pre-treatment)||||
71840239|NCT02969707|143189637|SUPERIORITY|We assessed the superiority of active over sham.|Mann-Whitney U statistic|702.5|||=|0.412|TWO_SIDED||||||Mann-Whitney U-test 2-tailed|||Pre- to post-rTMS change in HIS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.412
71840240|NCT02969707|143189640|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|2-sample t-test||||||0.037
71893193|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75||||0.7289|TWO_SIDED|95.0|-12.88|16.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||16.38|-12.88|0.7289
71893194|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71893195|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.6921|TWO_SIDED|95.0|-4.43|2.95|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.||2.95|-4.43|0.6921
71893196|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9788|TWO_SIDED|95.0|-0.19|0.19|||t-test, 2 sided|||Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.||0.19|-0.19|0.9788
71796235|NCT02623803|143090863|SUPERIORITY|||||||0.0404|||||||Wilcoxon (Mann-Whitney)|||||||0.0404
71796236|NCT02623803|143090864|SUPERIORITY|||||||0.5314|||||||Wilcoxon (Mann-Whitney)|||||||0.5314
71796237|NCT02623803|143090865|SUPERIORITY|||||||0.3166|||||||Wilcoxon (Mann-Whitney)|||||||0.3166
71796238|NCT02623803|143090866|SUPERIORITY|||||||0.2363|||||||Wilcoxon (Mann-Whitney)|||||||0.2363
71796239|NCT02623803|143090867|SUPERIORITY|||||||0.9171|||||||Wilcoxon (Mann-Whitney)|||||||0.9171
71796240|NCT02623803|143090868|SUPERIORITY|||||||0.4194|||||||Wilcoxon (Mann-Whitney)|||||||0.4194
71796241|NCT02623803|143090869|SUPERIORITY|||||||0.7073|||||||Wilcoxon (Mann-Whitney)|||||||0.7073
71796242|NCT02623803|143090870|SUPERIORITY|||||||0.5107|||||||Wilcoxon (Mann-Whitney)|||||||0.5107
71796243|NCT02623803|143090871|SUPERIORITY|||||||0.8339|||||||Wilcoxon (Mann-Whitney)|||||||0.8339
71796244|NCT02623803|143090872|SUPERIORITY|||||||0.8927|||||||Wilcoxon (Mann-Whitney)|||||||0.8927
71796245|NCT00449956|143090926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||95.0|-1.3|-0.06|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||-0.06|-1.30|
71796246|NCT00449956|143090926|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 1.2 mmHg|Mean Difference (Final Values)|0.28||||||95.0|-0.22|0.78|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.|||0.78|-0.22|
71796247|NCT01988571|143090970|SUPERIORITY|Power described in protocol.|Mean Difference (Net)|0.1608|STANDARD_ERROR_OF_MEAN|0.7787||0.84|TWO_SIDED||||||ANCOVA|Adjusted for multiple imputation of missing data||Linear models adjusting for baseline values and utilized multiple imputation for missing data.||||0.84
71796248|NCT00004412|143090980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.05|TWO_SIDED||||||Fisher Exact|||Percentage of ulcers undergoing partial and complete healing compared at 12 weeks. Mean Ulcer areas were calculated utilizing computerized planimetry, ulcer area tracings, and photography for baseline and 12 weeks and compared between the two study Arms.||||0.05
71796249|NCT03144180|143090984|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.|Confidence Interval for a mean|49.0|STANDARD_DEVIATION|47.0|||TWO_SIDED|95.0|15.459|82.571||||||||82.571|15.459|
71796250|NCT03144180|143090985|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.0295||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.0295
71796251|NCT03144180|143090986|EQUIVALENCE|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.403||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||0.403
71796252|NCT02346136|143090994|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.62|TWO_SIDED|95.0|-0.62|0.37||Tested as two-tailed p\<0.025 to accommodate two co-primary outcomes|Mixed Models Analysis|||||0.37|-0.62|0.62
71796253|NCT02346136|143090995|SUPERIORITY||Risk Ratio (RR)|0.535||||0.194|TWO_SIDED|95.0|0.182|1.57|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.57|0.182|0.194
71796254|NCT02346136|143090996|SUPERIORITY||Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|0.94||0.5|TWO_SIDED|95.0|-2.53|1.24|||Mixed Models Analysis|||||1.24|-2.53|.50
71796255|NCT02346136|143090997|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.85|TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Gait NW velocity variable||.05|-.04|.85
71796256|NCT02346136|143090997|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.26|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|||Gait DT velocity variable||.06|-.02|.26
71796257|NCT02346136|143090998|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.02||0.84|TWO_SIDED|95.0|-0.04|0.03|||Mixed Models Analysis|||||0.03|-0.04|0.84
71796258|NCT02346136|143090999|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|0.71||0.26|TWO_SIDED|95.0|-0.61|2.22|||Mixed Models Analysis|||||2.22|-0.61|.26
71796259|NCT02346136|143091000|SUPERIORITY||Median Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|7.29||0.92|TWO_SIDED|95.0|-13.9|15.3|||Mixed Models Analysis|||||15.3|-13.9|.92
71796260|NCT02346136|143091001|SUPERIORITY||Median Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|9.28||0.88|TWO_SIDED|95.0|-17.2|19.9|||Mixed Models Analysis|||||19.9|-17.2|.88
71796261|NCT02346136|143091002|SUPERIORITY||Mean Difference (Net)|0.85|STANDARD_ERROR_OF_MEAN|1.43||0.55|TWO_SIDED|95.0|-2.0|3.71|||Mixed Models Analysis|||Physical component score||3.71|-2.00|.55
71893197|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.2747|TWO_SIDED|95.0|-0.33|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.||0.09|-0.33|0.2747
71893198|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.2776|TWO_SIDED|95.0|-0.5|0.14|||t-test, 2 sided|||Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.||0.14|-0.50|0.2776
71893199|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.1403|TWO_SIDED|95.0|-0.62|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.||0.09|-0.62|0.1403
71673708|NCT02314260|142865723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.806|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.693|0.919||Under the nonparametric assumption P value \<0.05 is statistically significant|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)||0.919|0.693|0.000
71673709|NCT02314260|142865724|SUPERIORITY_OR_OTHER||Slope|4.5|STANDARD_ERROR_OF_MEAN|0.0318||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
71673710|NCT02314260|142865725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|STANDARD_ERROR_OF_MEAN|0.0578||0|TWO_SIDED|95.0|0.0|10.0||P\<0.05 is significant|t-test, 2 sided||at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.||10|0.00|0.000
71673711|NCT03612596|142865727|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71673712|NCT03612596|142865728|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
71796262|NCT02346136|143091002|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.66||0.51|TWO_SIDED|95.0|-4.41|2.21|||Mixed Models Analysis|||Mental component score||2.21|-4.41|.51
71796263|NCT02346136|143091003|SUPERIORITY||Median Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.0||0.69|TWO_SIDED|95.0|-1.6|2.41|||Mixed Models Analysis|||||2.41|-1.60|.69
71796264|NCT02346136|143091004|SUPERIORITY||Mean Difference (Net)|2.14|STANDARD_ERROR_OF_MEAN|2.56||0.41|TWO_SIDED|95.0|-2.98|7.26||to accommodate two co-primary outcomes|Mixed Models Analysis|||||7.26|-2.98|0.41
71796265|NCT02346136|143091006|SUPERIORITY||Risk Ratio (RR)|0.476||||0.06|TWO_SIDED|95.0|0.216|1.05|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.|||1.05|0.216|0.060
71796266|NCT02346136|143091007|SUPERIORITY||Mean Difference (Net)|1.27|STANDARD_ERROR_OF_MEAN|0.81||0.13|TWO_SIDED|95.0|-0.4|2.94|||Mixed Models Analysis|||||2.94|-0.40|0.13
71796267|NCT01052545|143091009|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.|Regression, Logistic|to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.||||||<0.05
71796268|NCT01052545|143091015|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||We used χ2 test, Fisher's exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.|Regression, Logistic|||||||<0.05
71796269|NCT00453999|143091018|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Log Rank|Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.||||||0.306
71796270|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796271|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796272|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796273|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796274|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796275|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796276|NCT00453999|143091019|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14||||>0.05
71796277|NCT00453999|143091020|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Log Rank|||||||0.276
71796278|NCT00453999|143091022|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||Log Rank|||||||0.994
71796279|NCT00453999|143091023|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 12 hours||||>0.05
71796280|NCT00453999|143091023|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 24 hours||||>0.05
71796281|NCT00453999|143091023|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 36 hours||||>0.05
71796282|NCT00453999|143091023|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 48 hours||||>0.05
71840241|NCT02969707|143189640|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
71840242|NCT02969707|143189640|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
71840243|NCT02969707|143189645|SUPERIORITY|We assessed the superiority of active over sham.|Cohen's d|-0.234||||0.49|TWO_SIDED||||||Mixed-effects model|||We used standard mixed-effects modeling to estimate the change (slope) in pain in our 2\*2 pre- and post-assessment design. Pain ratings were calculated by averaging pain ratings across 5 assessments under four conditions (TMS with hypnosis, TMS without hypnosis, Sham with hypnosis, Sham without hypnosis). Based on these change estimates, we derived the two main effects (TMS, Hypnosis) and their interaction effect on the change in pain from the pre- to post-treatment assessment.||||0.49
71840244|NCT02969707|143189646|SUPERIORITY|We assessed the superiority of active over sham.|||||=|0.454|||||||t-test, 2 sided|||Pre- to post-rTMS change in SOARS scores were calculated for both Active and Sham conditions. Two-tailed t-tests were used to evaluate the difference between the two conditions' change scores.||||=.454
71673713|NCT03612596|142865729|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71673714|NCT03612596|142865730|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71673715|NCT03612596|142865731|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71673716|NCT03612596|142865732|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.26) rather than test efficacy.||||||0.53
71673717|NCT03612596|142865733|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 1.16) rather than test efficacy.||||||0.44
71796283|NCT00453999|143091023|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 72 hours||||>0.05
71796284|NCT00453999|143091023|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Change from Baseline at 96 hours||||>0.05
71796285|NCT00802412|143091025|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.51|TWO_SIDED|95.0|0.4|6.5|||Regression, Logistic|||||6.5|0.4|0.51
71796286|NCT00802412|143091025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.45|TWO_SIDED|95.0|0.66|2.55|||Regression, Cox|||||2.55|0.66|.45
71796287|NCT00606892|143091026|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.||||<0.05
71796288|NCT00606892|143091027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_DEVIATION|40.0|<|0.3|TWO_SIDED|95.0|||||ANOVA|F(1,10)=1.1||||||<0.3
71796289|NCT00606892|143091028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0||||Values of p\<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p\<0.016.|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.||||<0.05
71796290|NCT00606892|143091029|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P\<0.016|ANOVA|Two-tailed tests were applied for main effects with P\<0.05||A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.||||<0.05
71796291|NCT01354496|143091063|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.03|||||TWO_SIDED|90.0|0.897|1.18|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.18|0.897|
71796292|NCT01354496|143091064|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.06|||||TWO_SIDED|90.0|0.922|1.22|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.22|0.922|
71796293|NCT01354496|143091065|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.02|||||TWO_SIDED|90.0|0.896|1.16|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.16|0.896|
71796294|NCT01354496|143091066|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.882|1.15|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.15|0.882|
71796295|NCT01354496|143091068|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.993|||||TWO_SIDED|90.0|0.951|1.04|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.951|
71796296|NCT01354496|143091068|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.943|||||TWO_SIDED|90.0|0.905|0.983|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.983|0.905|
71796297|NCT01354496|143091069|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.98|||||TWO_SIDED|90.0|0.926|1.04|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||1.04|0.926|
71796298|NCT01354496|143091069|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|0.94|||||TWO_SIDED|90.0|0.891|0.993|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.|||0.993|0.891|
71796299|NCT01228747|143091070|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-56.13|STANDARD_ERROR_OF_MEAN|6.15|<|0.0001|TWO_SIDED|95.0|-68.24|-44.02||Statistical testing was 2-sided, and was performed using a significance (α) level of 0.05.|ANCOVA|||"The statistical hypotheses, null hypothesis (H0) and alternate hypothesis (H1), are stated below:~H0: μLEV = μPBO vs. H1: μLEV ≠ μPBO~ANCOVA on the endpoint percentage change from Combined Baseline of GTC seizures per week using treatment and country as factors (categorical predictors) and Combined Baseline GTC seizure frequency per week as a covariate (a continuous predictor) where μLEV and μPBO are adjusted means for LEV and PBO, respectively."||-44.02|-68.24|<0.0001
71796300|NCT02442778|143091101|SUPERIORITY||Least Squares (LS) Mean Difference|0.4||||0.789|TWO_SIDED|95.0|-2.7|3.5||MMRM included fixed effect treatment,visit,treatment-by-visit,baseline,baseline-by-visit,baseline Neuropsychiatric Inventory Agitation/Aggression(NPI AA)(≤6 vs. \>6),falls risk assessment,baseline concomitant use of antipsychotic medications,cohorts.|MMRM|||||3.5|-2.7|0.789
71796301|NCT02442778|143091101|SUPERIORITY||LS Mean Difference|-2.0||||0.2|TWO_SIDED|95.0|-5.0|1.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.0|-5.0|0.200
71796302|NCT02442778|143091102|SUPERIORITY||LS Mean Difference|0.1||||0.484|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.484
71796303|NCT02442778|143091102|SUPERIORITY||LS Mean Difference|-0.1||||0.704|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.704
71796304|NCT02442778|143091103|SUPERIORITY||LS Mean Difference|-0.3||||0.416|TWO_SIDED|95.0|-0.9|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.9|0.416
71796305|NCT02442778|143091103|SUPERIORITY||LS Mean Difference|-0.6||||0.066|TWO_SIDED|95.0|-1.3|0.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.0|-1.3|0.066
71796306|NCT02442778|143091104|SUPERIORITY||LS Mean Difference|-0.2||||0.249|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.249
71796307|NCT02442778|143091104|SUPERIORITY||LS Mean Difference|-0.2||||0.199|TWO_SIDED|95.0|-0.5|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.5|0.199
71840245|NCT02969707|143189647|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.023|||||||Regression, Linear|(R² = .104, F(2,48) = 2.794, β = .320, p = .023)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to water was assessed.||||0.023
71840246|NCT02969707|143189647|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to water and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.043|||||||Regression, Linear|(R² = .081, F(1,49) = 4.315, β = .284, p = .043)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to water was assessed.||||0.043
71796308|NCT02442778|143091105|SUPERIORITY||LS Mean Difference|0.0||||0.975|TWO_SIDED|95.0|-0.7|0.7||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.7|-0.7|0.975
71840247|NCT02969707|143189647|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Tolerance with E/I as the independent variable and Thermal Pain Tolerance as the dependent variable.||||||0.022|||||||Regression, Linear|(R² = .103, F(1,49) = 5.632, β = .321, p = .022)||In people with FMS, the linear relationship between Thermal Pain Tolerance and E/I ratio as it relates to creatine was assessed.||||0.022
71840248|NCT02969707|143189647|OTHER|Linear regression was used to evaluate the scalar relationship between E/I ratio as it relates to creatine and Thermal Pain Threshold with E/I as the independent variable and Thermal Pain Threshold as the dependent variable.||||||0.041|||||||Regression, Linear|(R² = .083, F(1,49) = 4.425, β = .288, p = .041)||In people with FMS, the linear relationship between Thermal Pain Threshold and E/I ratio as it relates to creatine was assessed.||||0.041
71840249|NCT02969707|143189653|SUPERIORITY|||||||0.728|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to creatine is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to creatine.||||0.728
71893200|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9151|TWO_SIDED|95.0|-0.55|0.5|||t-test, 2 sided|||Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.||0.50|-0.55|0.9151
71796309|NCT02442778|143091105|SUPERIORITY||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-1.0|0.334
71796310|NCT02442778|143091106|SUPERIORITY||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.4|2.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.2|-2.4|0.934
71840250|NCT02969707|143189653|SUPERIORITY|||||||0.72|||||||ANCOVA|||Standard ANCOVA testing whether the Post-TMS E/I relative to water is predicted for each subject by the intervention (Active / Sham) while covarying for the Pre-TMS E/I ratio relative to water.||||0.720
71840251|NCT02675777|143189723|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71893201|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.3277|TWO_SIDED|95.0|-0.36|1.05|||t-test, 2 sided|||Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.||1.05|-0.36|0.3277
71796311|NCT02442778|143091106|SUPERIORITY||LS Mean Difference|1.1||||0.342|TWO_SIDED|95.0|-1.2|3.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||3.4|-1.2|0.342
71796312|NCT02442778|143091107|SUPERIORITY||LS Mean Difference|0.0||||0.888|TWO_SIDED|95.0|-0.7|0.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.6|-0.7|0.888
71893202|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.86|0.86|||t-test, 2 sided|||Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.||0.86|-0.86|1.0000
71893203|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57||||0.5661|TWO_SIDED|95.0|-1.53|2.67|||t-test, 2 sided|||Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.||2.67|-1.53|0.5661
71796313|NCT02442778|143091107|SUPERIORITY||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.3|-0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.1|-1.3|0.019
71796314|NCT02442778|143091108|SUPERIORITY||LS Mean Difference|0.6||||0.756|TWO_SIDED|95.0|-2.9|4.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||4.0|-2.9|0.756
71796315|NCT02442778|143091108|SUPERIORITY||LS Mean Difference|-3.6||||0.038|TWO_SIDED|95.0|-7.0|-0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||-0.2|-7.0|0.038
71796316|NCT02442778|143091109|SUPERIORITY||LS Mean Difference|-0.1||||0.468|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.468
71796317|NCT02442778|143091109|SUPERIORITY||LS Mean Difference|-0.1||||0.158|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.158
71796318|NCT02442778|143091110|SUPERIORITY||LS Mean Difference|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.4|-0.2|0.400
71796319|NCT02442778|143091110|SUPERIORITY||LS Mean Difference|-0.1||||0.566|TWO_SIDED|95.0|-0.3|0.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.2|-0.3|0.566
71796320|NCT02442778|143091111|SUPERIORITY||LS Mean Difference|0.0||||0.751|TWO_SIDED|95.0|-0.2|0.3||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.3|-0.2|0.751
71796321|NCT02442778|143091111|SUPERIORITY||LS Mean Difference|-0.1||||0.32|TWO_SIDED|95.0|-0.3|0.1||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.1|-0.3|0.320
71796322|NCT02442778|143091112|SUPERIORITY||LS Mean Difference|0.3||||0.782|TWO_SIDED|95.0|-1.8|2.4||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.4|-1.8|0.782
71796323|NCT02442778|143091112|SUPERIORITY||LS Mean Difference|0.0||||0.991|TWO_SIDED|95.0|-2.1|2.0||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.0|-2.1|0.991
71796324|NCT02442778|143091113|SUPERIORITY||LS Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.2||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.2|0.0|0.038
71796325|NCT02442778|143091113|SUPERIORITY||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.6|0.5||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||0.5|-0.6|0.911
71796326|NCT02442778|143091115|SUPERIORITY||LS Mean Difference|1.0||||0.236|TWO_SIDED|95.0|-0.6|2.6||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||2.6|-0.6|0.236
71796327|NCT02442778|143091115|SUPERIORITY||LS Mean Difference|0.3||||0.684|TWO_SIDED|95.0|-1.3|1.9||MMRM included fixed effect treatment, visit, treatment-by-visit, baseline, baseline-by-visit, baseline NPI AA (≤ 6 vs. \> 6), risk assessment for falls, baseline concomitant use of antipsychotic medications and cohorts.|MMRM|||||1.9|-1.3|0.684
71796328|NCT00603746|143091119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.275|||<|0.001||95.0|0.18|0.37|||ANCOVA|||||0.370|0.180|<0.001
71796329|NCT00603746|143091119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.272|||<|0.001|TWO_SIDED|95.0|0.178|0.367|||ANCOVA|||||0.367|0.178|<0.001
71673718|NCT03612596|142865734|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|Please note that this analysis was not powered and was used to characterize effect size (d = 0.67) rather than test efficacy.||||||0.93
71796330|NCT00603746|143091119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.264|||<|0.001|TWO_SIDED|95.0|0.171|0.357|||ANCOVA|||||0.357|0.171|<0.001
71796331|NCT00603746|143091119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.131|0.32|||ANCOVA|||||0.320|0.131|<0.001
71796332|NCT00603746|143091119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.001|TWO_SIDED|95.0|0.105|0.291|||ANCOVA|||||0.291|0.105|<0.001
71796333|NCT02917031|143091197|SUPERIORITY||Mean Difference (Final Values)|-2.595||||0.252|TWO_SIDED|95.0|-7.04|1.85|||ANCOVA|||Change from baseline, saxagliptin versus placebo.||1.850|-7.040|0.252
71796334|NCT02917031|143091198|SUPERIORITY||Mean Difference (Final Values)|-1.631||||0.425|TWO_SIDED|95.0|-5.635|2.373|||ANCOVA|||Saxagliptin: Change from baseline||2.373|-5.635|0.425
71796335|NCT02917031|143091199|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.925|TWO_SIDED|95.0|-1.996|2.197|||ANCOVA|||"Saxagliptin vs Placebo:~Change from baseline"||2.197|-1.996|0.925
71796336|NCT02917031|143091200|SUPERIORITY||Mean Difference (Final Values)|-3.605||||0.105|TWO_SIDED|95.0|-7.97|0.76|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||0.760|-7.970|0.105
71796337|NCT02917031|143091201|SUPERIORITY||Ratio for relative change|0.971||||0.796|TWO_SIDED|95.0|0.777|1.214|||ANCOVA|||Saxagliptin vs placebo: Change from baseline||1.214|0.777|0.796
71840252|NCT02675777|143189724|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
71893204|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7309|TWO_SIDED|95.0|-2.95|2.15|||t-test, 2 sided|||Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.||2.15|-2.95|0.7309
71796338|NCT04041869|143091203|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||In order to test the effect of the intervention on physical activity, linear mixed models examined changes in steps per day from study baseline (week 0) to the end of the active intervention (week 8).||||<0.01
71796339|NCT00913744|143091248|SUPERIORITY_OR_OTHER||Difference in proportions|12.3||||0.262|TWO_SIDED|95.0|-3.7|28.4|||Fisher Exact|P-value is from Fisher's exact test, comparing sham and ocriplasmin.||||28.4|-3.7|0.262
71796340|NCT00805935|143091249|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.000
71796341|NCT00805935|143091249|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
71796342|NCT00805935|143091249|SUPERIORITY_OR_OTHER|||||||0.481||95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.||||0.481
71796343|NCT00805935|143091249|SUPERIORITY_OR_OTHER|||||||0.483|TWO_SIDED|95.0|||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.||||0.483
71796344|NCT01344369|143091271|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.44|||||TWO_SIDED|90.0|93.08|112.75|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.75|93.08|
71796345|NCT01344369|143091272|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.58|||||TWO_SIDED|90.0|96.66|104.66|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.66|96.66|
71796346|NCT01344369|143091273|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.85|||||TWO_SIDED|90.0|96.43|105.48|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.48|96.43|
71796347|NCT01344369|143091274|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.59|||||TWO_SIDED|90.0|93.69|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.00|93.69|
71796348|NCT01344369|143091275|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.68|||||TWO_SIDED|90.0|92.76|100.77|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.77|92.76|
71893205|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.25||||0.3273|TWO_SIDED|95.0|-2.16|4.66|||t-test, 2 sided|||Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.||4.66|-2.16|0.3273
71673719|NCT03612596|142865735|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
71673720|NCT03612596|142865736|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||||||0.16
71796349|NCT01344369|143091276|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.44|||||TWO_SIDED|90.0|92.22|100.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.84|92.22|
71796350|NCT00283439|143091377|SUPERIORITY_OR_OTHER|||||||0.9654||||||One-sided test|Satterhwaite t-test|||||||0.9654
71796351|NCT00283439|143091377|SUPERIORITY_OR_OTHER|||||||0.869||||||One-sided test|Satterhwaite t-test|||||||0.8690
71796352|NCT00283439|143091377|SUPERIORITY_OR_OTHER|||||||0.7133||||||One-sided test|Satterhwaite t-test|||||||0.7133
71893206|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.||0|0|<0.0001
71673721|NCT03612596|142865737|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71796353|NCT00283439|143091378|SUPERIORITY_OR_OTHER|||||||0.294|||||||Fisher Exact|||||||0.294
71796354|NCT00283439|143091378|SUPERIORITY_OR_OTHER|||||||0.608|||||||Fisher Exact|||||||0.608
71796355|NCT00283439|143091378|SUPERIORITY_OR_OTHER|||||||0.603|||||||Fisher Exact|||||||0.603
71796356|NCT00283439|143091379|SUPERIORITY_OR_OTHER|||||||0.091|||||||Satterhwaite t-test|||||||0.091
71796357|NCT00283439|143091379|SUPERIORITY_OR_OTHER|||||||0.3|||||||Satterhwaite t-test|||||||0.300
71673722|NCT03612596|142865738|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71673723|NCT03612596|142865739|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71673724|NCT02573181|142865746|OTHER|Difference in percentage with AEs|Difference|4.2|||||TWO_SIDED|95.0|-7.4|15.8|||||Difference and 95% CI calculated based on Miettinen \& Nurminen method.|||15.8|-7.4|
71796358|NCT00283439|143091379|SUPERIORITY_OR_OTHER|||||||0.881|||||||Satterhwaite t-test|||||||0.881
71796359|NCT00283439|143091380|SUPERIORITY_OR_OTHER|||||||0.576|||||||Fisher Exact|||||||0.576
71796360|NCT00283439|143091380|SUPERIORITY_OR_OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
71796361|NCT00283439|143091380|SUPERIORITY_OR_OTHER|||||||0.421|||||||Fisher Exact|||||||0.421
71796362|NCT00430092|143091396|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mantel Haenszel|||||||<0.0001
71796363|NCT02624284|143091433|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on latency to smoke. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.94|||||||Regression, Linear|||||||0.94
71796364|NCT02624284|143091434|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on number of cigarettes smoked. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.53|||||||Regression, Linear|||||||0.53
71796365|NCT02624284|143091436|SUPERIORITY|Analysis: Multiple regression predicting main effects of dose on days of abstinence. Age, sex, race and nicotine dependence were included as covariates.||||||0.78|||||||Regression, Linear|||||||0.78
71796366|NCT00265616|143091503|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71796367|NCT00265616|143091504|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Fisher Exact|||||||0.67
71796368|NCT00265616|143091505|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71796369|NCT00265616|143091507|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Fisher Exact|||||||0.4
71796370|NCT00265616|143091508|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71796371|NCT01604343|143091528|SUPERIORITY_OR_OTHER||Percentage Difference|28.4|||<|0.001|TWO_SIDED|95.0|22.8|33.8|||Cochran-Mantel-Haenszel|||||33.8|22.8|< 0.001
71796372|NCT01604343|143091528|SUPERIORITY_OR_OTHER||Percentage Difference|27.1|||<|0.001|TWO_SIDED|95.0|21.6|32.6|||Cochran-Mantel-Haenszel|||||32.6|21.6|< 0.001
71796373|NCT01604343|143091529|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
71796374|NCT01604343|143091529|SUPERIORITY_OR_OTHER||||||<|0.001|||||||van der waerden ANOVA|||||||< 0.001
71796375|NCT01604343|143091530|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.226|||<|0.001|TWO_SIDED|95.0|-0.29|-0.17|||ANCOVA|||||-0.17|-0.29|<0.001
71840253|NCT00691002|143189738|SUPERIORITY||Odds Ratio (OR)|1.28||||0.11|TWO_SIDED|95.0|0.94|1.74|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus calcipotriol ointment at Week 8 LOCF (Last Observation Carried Forward).||1.74|0.94|0.11
71840254|NCT00691002|143189738|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.31|2.45|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus hydrocortisone ointment at Week 8 LOCF (Last Observation Carried Forward).||2.45|1.31|<0.001
71840255|NCT00691002|143189738|SUPERIORITY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|95.0|1.8|4.04|||Cochran-Mantel-Haenszel|||Test for superiority of LEO 80190 ointment versus ointment vehicle at Week 8 LOCF (Last Observation Carried Forward).||4.04|1.80|<0.001
71796376|NCT01604343|143091530|SUPERIORITY_OR_OTHER||LS mean difference|-0.256|||<|0.001|TWO_SIDED|95.0|-0.32|-0.2|||ANCOVA|||||-0.20|-0.32|<0.001
71796377|NCT01604343|143091531|SUPERIORITY_OR_OTHER||Percentage Difference|17.8|||<|0.001|TWO_SIDED|95.0|13.1|22.4|||Cochran-Mantel-Haenszel|||||22.4|13.1|< 0.001
71796378|NCT01604343|143091531|SUPERIORITY_OR_OTHER||Percentage Difference|20.8|||<|0.001|TWO_SIDED|95.0|16.1|25.6|||Cochran-Mantel-Haenszel|||||25.6|16.1|< 0.001
71796379|NCT01604343|143091532|SUPERIORITY_OR_OTHER||Percentage Difference|20.5|||<|0.001|TWO_SIDED|95.0|16.4|24.6|||Cochran-Mantel-Haenszel|||||24.6|16.4|< 0.001
71796380|NCT01604343|143091532|SUPERIORITY_OR_OTHER||Percentage Difference|19.9|||<|0.001|TWO_SIDED|95.0|15.8|24.0|||Cochran-Mantel-Haenszel|||||24.0|15.8|< 0.001
71796381|NCT01604343|143091533|SUPERIORITY_OR_OTHER||Percentage Difference|3.6||||0.001|TWO_SIDED|95.0|1.4|5.8|||Cochran-Mantel-Haenszel|||||5.8|1.4|0.001
71796382|NCT01604343|143091533|SUPERIORITY_OR_OTHER||Percentage Difference|7.2|||<|0.001|TWO_SIDED|95.0|4.6|9.8|||Cochran-Mantel-Haenszel|||||9.8|4.6|< 0.001
71796383|NCT03754959|143091600|OTHER||Ratio|97.9|||||TWO_SIDED|90.0|90.2|106.2|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.2|90.2|
71796384|NCT03754959|143091600|OTHER||Ratio|95.9|||||TWO_SIDED|90.0|89.9|102.4|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|||102.4|89.9|
71796385|NCT03754959|143091600|OTHER||Ratio|101.0|||||TWO_SIDED|90.0|96.3|106.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.1|96.3|
71796386|NCT03754959|143091600|OTHER||Ratio|93.7|||||TWO_SIDED|90.0|86.8|101.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||101.1|86.8|
71840256|NCT01959607|143189817|OTHER||Geometric LS Mean Ratio|103.5|||||TWO_SIDED|95.0|84.94|126.11|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||126.11|84.94|
71796387|NCT03754959|143091600|OTHER||Ratio|93.1|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
71796388|NCT03754959|143091600|OTHER||Ratio|90.0|||||TWO_SIDED|90.0|83.8|96.7|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||96.7|83.8|
71796389|NCT03754959|143091601|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|95.6|116.9|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||116.9|95.6|
71796390|NCT03754959|143091601|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|106.5|129.6|||||Ratio is calculated with BI 1358894 10 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||129.6|106.5|
71796391|NCT03754959|143091601|OTHER||Ratio|112.6|||||TWO_SIDED|90.0|102.9|123.1|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.1|102.9|
71796392|NCT03754959|143091601|OTHER||Ratio|110.3|||||TWO_SIDED|90.0|90.1|135.1|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||135.1|90.1|
71796393|NCT03754959|143091601|OTHER||Ratio|96.4|||||TWO_SIDED|90.0|84.5|110.1|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||110.1|84.5|
71796394|NCT03754959|143091601|OTHER||Ratio|89.3|||||TWO_SIDED|90.0|74.9|106.4|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA model on the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||106.4|74.9|
71796395|NCT03754959|143091602|OTHER||Ratio|98.3|||||TWO_SIDED|90.0|84.2|114.8|||||Ratio is calculated with Placebo+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.8|84.2|
71840257|NCT01959607|143189818|OTHER||Geometric LS Mean Ratio|96.34|||||TWO_SIDED|95.0|85.1|109.07|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||109.07|85.10|
71893207|NCT00609622|143307429|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.7108|TWO_SIDED|95.0|-0.39|0.27|||t-test, 2 sided|||Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.||0.27|-0.39|0.7108
71796396|NCT03754959|143091602|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|87.9|109.3|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||109.3|87.9|
71796397|NCT03754959|143091602|OTHER||Ratio|117.5|||||TWO_SIDED|90.0|102.6|134.6|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||134.6|102.6|
71796398|NCT03754959|143091602|OTHER||Ratio|94.5|||||TWO_SIDED|90.0|85.5|104.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||104.4|85.5|
71840258|NCT01456949|143189834|SUPERIORITY||Kaplan-Meier (product-limit) estimator|66.9|||<|0.001|TWO_SIDED|95.0|61.6|71.7|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||71.7|61.6|<0.001
71893208|NCT01696461|143307436|OTHER||||||||||||||||||Percentage of donors mobilized with plerixafor. No comparison group was analyzed.|||
71796399|NCT03754959|143091602|OTHER||Ratio|98.2|||||TWO_SIDED|90.0|87.3|99.3|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||99.3|87.3|
71796400|NCT03754959|143091602|OTHER||Ratio|98.0|||||TWO_SIDED|90.0|84.3|114.0|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 1 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||114.0|84.3|
71796401|NCT03754959|143091603|OTHER||Ratio|95.5|||||TWO_SIDED|90.0|81.3|112.1|||||Ratio is calculated with Placebo+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||112.1|81.3|
71796402|NCT03754959|143091603|OTHER||Ratio|105.7|||||TWO_SIDED|90.0|91.5|122.0|||||Ratio is calculated with BI 1358894 10mg +Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||122.0|91.5|
71796403|NCT03754959|143091603|OTHER||Ratio|116.3|||||TWO_SIDED|90.0|90.9|148.7|||||Ratio is calculated with BI 1358894 25 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||148.7|90.9|
71796404|NCT03754959|143091603|OTHER||Ratio|106.8|||||TWO_SIDED|90.0|92.4|123.4|||||Ratio is calculated with BI 1358894 50 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||123.4|92.4|
71796405|NCT03754959|143091603|OTHER||Ratio|83.9|||||TWO_SIDED|90.0|71.2|98.9|||||Ratio is calculated with BI 1358894 100 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||98.9|71.2|
71796406|NCT03754959|143091603|OTHER||Ratio|87.2|||||TWO_SIDED|90.0|73.5|103.5|||||Ratio is calculated with BI 1358894 200 mg+Midazolam on day 14 in the nominator and the Midazolam on day -1 in the denominator.|The statistical model used for the analysis of the secondary endpoints was an ANOVA mode lon the logarithmic scale including 'treatment' ('midazolam' and 'midazolam + Placebo/BI') as fixed effect and 'subject' as random effect. The analysis was performed separately for Day 1 and Day 14.||103.5|73.5|
71796407|NCT02462967|143091604|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
71796408|NCT02462967|143091604|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
71796409|NCT02462967|143091605|SUPERIORITY|||||||0.447|||||||ANCOVA|||||||0.447
71796410|NCT02462967|143091605|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
71893209|NCT01696461|143307437|OTHER||||||||||||||||||This is a descriptive analysis. Percentage of donor experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3. Grade of maximum toxicity across all time points is reported.|||
71796411|NCT02462967|143091606|SUPERIORITY|||||||0.522|||||||ANCOVA|||||||0.522
71796412|NCT02462967|143091606|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.000
71796413|NCT02462967|143091607|SUPERIORITY|||||||0.943|||||||ANCOVA|||||||0.943
71796414|NCT02462967|143091607|SUPERIORITY|||||||0.492|||||||ANCOVA|||||||0.492
71796415|NCT02462967|143091608|SUPERIORITY|||||||0.832|||||||ANCOVA|||||||0.832
71796416|NCT02462967|143091608|SUPERIORITY|||||||0.558|||||||ANCOVA|||||||0.558
71796417|NCT02462967|143091609|SUPERIORITY|||||||0.362|||||||ANCOVA|||||||0.362
71796418|NCT02462967|143091609|SUPERIORITY|||||||0.602|||||||ANCOVA|||||||0.602
71796419|NCT02462967|143091610|SUPERIORITY|||||||0.633|||||||Chi-squared|||||||0.633
71796420|NCT02462967|143091610|SUPERIORITY|||||||0.814|||||||Chi-squared|||||||0.814
71796421|NCT03663283|143091650|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||||||.0197
71796422|NCT03663283|143091651|SUPERIORITY|||||||0.584|||||||Wilcoxon (Mann-Whitney)|||72 hours||||0.584
71796423|NCT03663283|143091651|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||3 weeks||||.5800
71796424|NCT03663283|143091652|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
71796425|NCT03663283|143091653|SUPERIORITY|||||||0.7018|||||||Wilcoxon (Mann-Whitney)|||72 hours||||.7018
71796426|NCT03663283|143091653|SUPERIORITY|||||||0.5327|||||||Wilcoxon (Mann-Whitney)|||Week 3||||.5327
71796427|NCT04120610|143091659|OTHER||Correlation|0.26|||||TWO_SIDED|95.0|0.1|0.41||||||Descriptive analysis of endpoint with no hypothesis.||0.41|0.10|
71796428|NCT04120610|143091660|OTHER||Correlation|-0.26|||||TWO_SIDED|95.0|-0.46|-0.03||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.03|-0.46|
71796429|NCT04120610|143091660|OTHER||Correlation|-0.33|||||TWO_SIDED|95.0|-0.51|-0.12||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.51|
71796430|NCT04120610|143091660|OTHER||Correlation|-0.13|||||TWO_SIDED|95.0|-0.38|0.14||||||Correlation of change in acceleration time and ABI. Descriptive analysis of endpoint with no hypothesis.||0.14|-0.38|
71796431|NCT04120610|143091661|OTHER||Correlation|-0.34|||||TWO_SIDED|95.0|-0.52|-0.12||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.12|-0.52|
71673725|NCT02573181|142865748|OTHER|Difference in % with fatigue|Fatigue difference|-0.9|||||TWO_SIDED|95.0|-10.7|8.8|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||8.8|-10.7|
71893210|NCT01696461|143307438|OTHER||||||||||||||||||This is a descriptive analysis. The number of donors experiencing toxicities was assessed at 30, 60, 120, and 240 minutes after administration of plerixafor on each day of collection and one, six, and 12 months post-donation. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.3.|||
71673726|NCT02573181|142865748|OTHER|Difference in % with arthralgia|Arthralgia difference|-3.2|||||TWO_SIDED|95.0|-10.2|3.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||3.4|-10.2|
71673727|NCT02573181|142865748|OTHER|Difference in % with myalgia|Myalgia difference|4.6|||||TWO_SIDED|95.0|-3.9|13.3|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||13.3|-3.9|
71673728|NCT02573181|142865748|OTHER|Difference in % with headache|Headache difference|-2.5|||||TWO_SIDED|95.0|-11.4|6.4|||||Difference and 95% CI calculated based on the Miettinen \& Nurminen method.|||6.4|-11.4|
71796432|NCT04120610|143091661|OTHER||Correlation|-0.35|||||TWO_SIDED|95.0|-0.52|-0.15||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||-0.15|-0.52|
71796433|NCT04120610|143091661|OTHER||Correlation|-0.24|||||TWO_SIDED|95.0|-0.47|0.02||||||Correlation of change in acceleration time and TBI. Descriptive analysis of endpoint with no hypothesis.||0.02|-0.47|
71893211|NCT01696461|143307439|OTHER||||||||||||||||||At 100 days after HCT, all patients in both the MAC and the RIC cohorts had achieved neutrophil engraftment. All patients in the MAC arm and 97% of patients in the RIC arm had achieved platelet engraftment. The median time to neutrophil engraftment was 13 and 15 days for MAC and RIC, respectively. The median time to platelet engraftment was 19 and 18 days for MAC and RIC, respectively.|||
71673729|NCT03421210|142865755|OTHER|||||||0.001|||||||t-test, 1 sided|||Differences in brain activation in response to personal smoking versus standard smoking cues were examined.||||0.001
71796434|NCT04120610|143091662|OTHER||Correlation|0.15|||||TWO_SIDED|95.0|-0.08|0.36||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.36|-0.08|
71796435|NCT04120610|143091662|OTHER||Correlation|0.19|||||TWO_SIDED|95.0|-0.02|0.39||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.39|-0.02|
71796436|NCT04120610|143091662|OTHER||Correlation|0.24|||||TWO_SIDED|95.0|-0.02|0.47||||||Correlation of change in acceleration time and Rutherford Classification. Descriptive analysis of endpoint with no hypothesis.||0.47|-0.02|
71796437|NCT01874262|143091682|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
71796438|NCT04180020|143091741|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71796439|NCT00717769|143091761|SUPERIORITY|||||||0.519|||||||ANCOVA|||Change from Baseline to Day 8||||0.519
71796440|NCT00717769|143091761|SUPERIORITY|||||||0.032|||||||ANCOVA|||Change from Baseline to Day 15||||0.032
71796441|NCT00717769|143091761|SUPERIORITY|||||||0.008|||||||ANCOVA|||Change from Baseline to Day 22||||0.008
71673730|NCT03777436|142865769|SUPERIORITY||Adjusted difference|20.1||||0.0003|TWO_SIDED|95.0|9.2|30.9|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||30.9|9.2|0.0003
71673731|NCT03777436|142865770|SUPERIORITY||Adjusted difference|15.2||||0.0004|TWO_SIDED|95.0|6.9|23.6|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||23.6|6.9|0.0004
71673732|NCT03777436|142865771|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|15.4|39.3|||Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the strata with the CMH weights. 2-sided 95% CIs based on the stratified Newcombe method. Two-sided p-values were based on the CMH test.|||39.3|15.4|<0.0001
71673733|NCT03777436|142865772|SUPERIORITY||Least squares mean difference|-3.33|STANDARD_ERROR_OF_MEAN|0.942||0.0005|TWO_SIDED|95.0|-5.18|-1.47|||MMRM||Based on MMRM model.|||-1.47|-5.18|0.0005
71673734|NCT03777436|142865773|SUPERIORITY||Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.79||0.0008|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Based on MMRM model.|||-1.1|-4.2|0.0008
71673735|NCT03777436|142865774|SUPERIORITY||Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001|TWO_SIDED|95.0|-20.3|-10.0|||MMRM||Based on MMRM model.|||-10.0|-20.3|<0.0001
71673736|NCT01342770|142865775|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Signed Rank|||||||0.06
71796442|NCT00717769|143091761|SUPERIORITY|||||||0.006|||||||ANCOVA|||Change from Baseline to Day 29||||0.006
71796443|NCT00717769|143091763|SUPERIORITY|||||||0.533|||||||ANCOVA|||Change from Baseline to Day 8||||0.533
71796444|NCT00717769|143091763|SUPERIORITY|||||||0.009|||||||ANCOVA|||Change from Baseline to Day 15||||0.009
71796445|NCT00717769|143091763|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change from Baseline to Day 22||||0.002
71796446|NCT00717769|143091763|SUPERIORITY|||||||0.003|||||||ANCOVA|||Change from Baseline to Day 29||||0.003
71796447|NCT01399593|143091810|SUPERIORITY||Proportion difference|-3.9||||0.76|TWO_SIDED|95.0|-23.9|16.3|||Fisher Exact|||||16.3|-23.9|0.76
71796448|NCT00403273|143091826|SUPERIORITY|||||||0.01||||||p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was \<0.05|t-test, 2 sided|||||||0.01
71813348|NCT02709005|143129188|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.13|0.08||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.08|-0.13|>0.999
71796449|NCT00403273|143091827|SUPERIORITY_OR_OTHER||comparison of proportions|0.65|||<|0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome|comparison of proportions|compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths \& all timepoints|we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.|For primary outcome analysis, we compared the proportion of responders with clinically meaningful change \[improvement\] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.||||<0.05
71796450|NCT00403273|143091828|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71796451|NCT00403273|143091829|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71796452|NCT00403273|143091830|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71796453|NCT00403273|143091831|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71796454|NCT00403273|143091832|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71796455|NCT01696435|143091836|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.62|TWO_SIDED|95.0|0.87|1.09||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.09|.87|0.62
71796456|NCT01696435|143091836|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.03|TWO_SIDED|95.0|1.01|1.26||P-value was not adjusted for multiple comparisons. A priori, two-sided tests with an alpha level of 0.025 were used to account for the 2 co-primary outcomes (depression event and mood scores).|Regression, Cox||Active treatment vs. Placebo comparison|||1.26|1.01|0.03
71796457|NCT01696435|143091837|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.04|0.05|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.05|-0.04|
71796458|NCT01696435|143091837|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.01|0.07|||Mixed Models Analysis|||Test of whether the mean difference in change comparing the treatment groups is different than zero. See full SAP for all details.||0.07|-0.01|
71796459|NCT01696435|143091838|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.13|0.87|0.88
71796460|NCT01696435|143091838|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.02|TWO_SIDED|95.0|1.03|1.33||P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.|Regression, Cox||Active treatment vs. Placebo comparison|||1.33|1.03|0.02
71796461|NCT01696435|143091839|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.67|TWO_SIDED|95.0|0.76|1.19|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.19|0.76|0.67
71796462|NCT01696435|143091839|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox||Active treatment vs. Placebo comparison|P-value not adjusted for multiple comparisons. This outcome was not a pre-specified primary outcome and results are to be interpreted with caution.||1.27|0.82|0.88
71796463|NCT01852292|143091854|OTHER|Double Criteria for PFS|Cox Proportional Hazard|0.646|||||TWO_SIDED|95.0|0.44|0.94||||||||0.94|0.44|
71796464|NCT01852292|143091855|OTHER|Double criteria for OS|Cox Proportional Hazard|0.72|||||TWO_SIDED|95.0|0.49|1.04||||||||1.04|0.49|
71796465|NCT02586012|143091866|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71796466|NCT02586012|143091867|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71796467|NCT02586012|143091868|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71796468|NCT03240575|143091901|SUPERIORITY||Mean Difference (Net)|0.052|STANDARD_ERROR_OF_MEAN|0.027||0.0543|TWO_SIDED|95.0|-0.001|0.105|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.105|-0.001|0.0543
71796469|NCT03240575|143091902|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.027||0.0011|TWO_SIDED|95.0|0.037|0.144|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.144|0.037|0.0011
71796470|NCT03240575|143091903|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.027||0.8593|TWO_SIDED|95.0|-0.048|0.058|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.058|-0.048|0.8593
71796471|NCT03240575|143091904|SUPERIORITY||Mean Difference (Net)|0.098|STANDARD_ERROR_OF_MEAN|0.029||0.001|TWO_SIDED|95.0|0.04|0.156|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.||||0.156|0.040|0.0010
71796472|NCT02223767|143091929|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|||||||0.025
71796473|NCT02223767|143091930|SUPERIORITY|||||||0.08|||||||t-test, 1 sided|||||||0.08
71796474|NCT02342704|143091932|SUPERIORITY_OR_OTHER|||||||0.126|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 4||||0.1260
71796475|NCT02342704|143091932|SUPERIORITY_OR_OTHER|||||||0.3525|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 4||||0.3525
71796476|NCT02342704|143091932|SUPERIORITY_OR_OTHER|||||||0.0127|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 12||||0.0127
71796477|NCT02342704|143091932|SUPERIORITY_OR_OTHER|||||||0.0299|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 12||||0.0299
71796478|NCT02342704|143091932|SUPERIORITY_OR_OTHER|||||||0.0123|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 24||||0.0123
71893212|NCT01696461|143307440|OTHER||||||||||||||||||"Full donor myeloid chimerism was achieved relatively quickly in both RIC and MAC groups (median 100% at day +28 in both RIC and MAC), but conversion to full donor T-cell chimerism appeared to be slower in the RIC patients.~T-cell chimerism for MAC patients: median donor cell % (range):~Day +28: 92(59-100)%, Day +100: 97(76-100)%, Day +180: 100(91-100)%, Day +365: 100(100-100)%~T-cell chimerism for RIC patients: median donor cell % (range):~Day +28: 80(50-100)%, Day +100: 84(64-100)%, Day +180: 95(74-100)%, Day +365: 100(87-100)%"|||
71893213|NCT01696461|143307441|OTHER||||||||||||||||||This is a descriptive outcome.There were no cases of primary graft failure.|||
71673737|NCT02347774|142865817|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.0736|STANDARD_ERROR_OF_MEAN|0.01989||0.0002|TWO_SIDED|95.0|0.0346|0.1127|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1127|0.0346|0.0002
71673738|NCT02347774|142865817|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.081|STANDARD_ERROR_OF_MEAN|0.02006||0.0001|TWO_SIDED|95.0|0.0416|0.1204|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1204|0.0416|0.0001
71673739|NCT02347774|142865818|SUPERIORITY||Least Mean Squared (SE)|0.082|STANDARD_ERROR_OF_MEAN|0.02055|<|0.0001|TWO_SIDED|95.0|0.0417|0.1224||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|I||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1224|0.0417|<0.0001
71796479|NCT02342704|143091932|SUPERIORITY_OR_OTHER|||||||0.0076|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 24||||0.0076
71893214|NCT01696461|143307442|OTHER|||||||||||||||||The cumulative incidence of acute graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of acute GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing risk.|||
71893215|NCT01696461|143307443|OTHER||||||||||||||||||Immune reconstitution was measured by CD3+CD4+ and CD3+CD8+ T cells in the peripheral blood of patients at days 28, 100, 180, and 365 after HCT. Notably, median CD3+CD4+ cell counts were \>200/µL at all times analyzed, including day 28 in both MAC and RIC groups.|||
71893216|NCT01696461|143307444|OTHER|||||||||||||||||Groups were not directly compared using a statistical test.|Percentage of recipients at-risk for CMV reactivation who experienced a reactivation.|||
71893217|NCT01696461|143307445|OTHER|||||||||||||||||The probability of treatment-related mortality and disease relapse/progression were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|The incidence of treatment-related mortality and relapse was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. When computing the cumulative incidence probability of treatment-related mortality and relapse, relapse and treatment-related mortality, respectively, were considered as a competing risk.|||
71893218|NCT01696461|143307446|OTHER|||||||||||||||||The probability of progression free survival and overall survival were examined in the RIC and MAC cohorts but were not directly compared between the two groups using a statistical test.|Kaplan-Meier curves were used to estimate the probability of progression-free survival and overall survival. Progression-free survival at 1 year was 53% (95% CI, 36% to 71%) after MAC and 64% (95% CI, 47% to 79%) after RIC. Overall survival at 1 year was 63% (95% CI, 46% to 79%) after MAC and 70% (95% CI, 53% to 84%) after RIC.|||
71893219|NCT01696461|143307447|OTHER|||||||||||||||||This outcome measure is descriptive.|This outcome measure is descriptive. The median cell dose and range are reported.|||
71893220|NCT01696461|143307448|OTHER|||||||||||||||||The cumulative incidence of chronic graft-vs-host disease was examined in the RIC and MAC groups but was not directly compared with a statistical test.|The incidence of chronic GVHD was quantified by computing the cumulative incidence probability and an appropriate 95% confidence interval. Death was treated as a competing event.|||
71893221|NCT01696461|143307449|OTHER||||||||||||||||||This is a descriptive analysis. There were no cases of secondary graft failure.|||
71893222|NCT01696461|143307450|OTHER||||||||||||||||||This outcome measure is descriptive. The median cell dose and range are reported.|||
71893223|NCT01245647|143307527|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
71893224|NCT01245647|143307528|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71893225|NCT01245647|143307529|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.46
71893226|NCT01245647|143307530|SUPERIORITY_OR_OTHER|||||||0.12||||||no significant difference by Fisher exact test|Fisher Exact|||||||0.12
71893227|NCT01245647|143307531|SUPERIORITY_OR_OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
71893228|NCT04321343|143307557|SUPERIORITY||Mean Difference (Final Values)|-25.313|STANDARD_ERROR_OF_MEAN|9.587||0.0083|TWO_SIDED|95.0|-44.1036|-6.5227|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.5227|-44.1036|0.0083
71796480|NCT02342704|143091933|SUPERIORITY_OR_OTHER|||||||0.5318|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T1 Lesion Volume Change||||0.5318
71796481|NCT02342704|143091933|SUPERIORITY_OR_OTHER|||||||0.0528|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T2 Lesion Volume Change||||0.0528
71796482|NCT02342704|143091935|SUPERIORITY_OR_OTHER|||||||0.2632|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||||||0.2632
71796483|NCT02347527|143091942|SUPERIORITY|||||||0.038|||||||ANOVA|||||||0.038
71796484|NCT02347527|143091942|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
71796485|NCT02347527|143091943|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71796486|NCT02347527|143091944|OTHER|||||||0.04|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.040
71796487|NCT02347527|143091944|OTHER|||||||0.92|||||||Pearson's correlation|||Relationship between change in high-calorie food ratings and subsequent food intake (kcals).||||0.92
71796488|NCT01632891|143091947|SUPERIORITY|Test used alpha level of 0.05||||||1|||||||Fisher Exact|||Compare proportions of Pf SCP clearance between treatment arms||||1.00
71796489|NCT04206293|143091963|SUPERIORITY||Least Squares (LS) Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.9||0.0736|TWO_SIDED|95.0|-0.2|3.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||3.6|-0.2|0.0736
71796490|NCT04206293|143091963|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.0||0.5259|TWO_SIDED|95.0|-1.5|2.8|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||2.8|-1.5|0.5259
71796491|NCT04206293|143091964|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.2||0.8848|TWO_SIDED|95.0|-2.8|2.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||2.4|-2.8|0.8848
71796492|NCT04206293|143091964|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.8||0.9505|TWO_SIDED|95.0|-1.8|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-1.8|0.9505
71796493|NCT04206293|143091965|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.6||0.0007|TWO_SIDED|95.0|1.4|4.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.0|1.4|0.0007
71796494|NCT04206293|143091965|SUPERIORITY||LS Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0033|TWO_SIDED|95.0|0.9|3.9|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||3.9|0.9|0.0033
71796495|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.095|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.119|-0.07|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 28||-0.070|-0.119|<0.0001
71796496|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.071|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|TWO_SIDED|95.0|-0.094|-0.048|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Uf: Change from Baseline to Day 84||-0.048|-0.094|<0.0001
71796497|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|-0.116|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 28||-0.061|-0.116|<0.0001
71796498|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|-0.102|-0.061|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ue: Change from Baseline to Day 84||-0.061|-0.102|<0.0001
71796499|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.079|STANDARD_ERROR_OF_MEAN|0.018||0.0003||95.0|-0.116|-0.041|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 28||-0.041|-0.116|0.0003
71796500|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|-0.103|-0.044|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ur: Change from Baseline to Day 84||-0.044|-0.103|0.0001
71796501|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.081|STANDARD_ERROR_OF_MEAN|0.017||0.0002|TWO_SIDED|95.0|-0.117|-0.045|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 28||-0.045|-0.117|0.0002
71796502|NCT04206293|143091966|SUPERIORITY||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.103|-0.052|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ua: Change from Baseline to Day 84||-0.052|-0.103|<0.0001
71796503|NCT04206293|143091967|SUPERIORITY||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.014||0.5786|TWO_SIDED|95.0|-0.038|0.022|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 28||0.022|-0.038|0.5786
71840259|NCT01456949|143189835|SUPERIORITY||Kaplan-Meier (product-limit) estimator|2.3|||<|0.001|TWO_SIDED|95.0|1.1|4.5|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.||||4.5|1.1|<0.001
71840260|NCT01456949|143189836|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Freedom from MAFE's was estimated using Kaplan-Meier methods.|||
71840261|NCT01456949|143189837|OTHER|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Chronic treatment success was estimated at one and two years using Kaplan-Meier methods.|||
71796504|NCT04206293|143091967|SUPERIORITY||LS Mean Difference|-0.023|STANDARD_ERROR_OF_MEAN|0.012||0.069|TWO_SIDED|95.0|-0.049|0.002|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q1: Change from Baseline to Day 84||0.002|-0.049|0.0690
71796505|NCT04206293|143091967|SUPERIORITY||LS Mean Difference|-0.021|STANDARD_ERROR_OF_MEAN|0.016||0.1934|TWO_SIDED|95.0|-0.054|0.012|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 28||0.012|-0.054|0.1934
71796506|NCT04206293|143091967|SUPERIORITY||LS Mean Difference|-0.034|STANDARD_ERROR_OF_MEAN|0.013||0.0194|TWO_SIDED|95.0|-0.062|-0.006|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q2: Change from Baseline to Day 84||-0.006|-0.062|0.0194
71796507|NCT04206293|143091967|SUPERIORITY||LS Mean Difference|0.013|STANDARD_ERROR_OF_MEAN|0.007||0.0652|TWO_SIDED|95.0|-0.001|0.028|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 28||0.028|-0.001|0.0652
71796508|NCT04206293|143091967|SUPERIORITY||LS Mean Difference|0.012|STANDARD_ERROR_OF_MEAN|0.006||0.0756|TWO_SIDED|95.0|-0.001|0.024|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Q3: Change from Baseline to Day 84||0.024|-0.001|0.0756
71796509|NCT04206293|143091968|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.68||0.8409|TWO_SIDED|95.0|-6.19|5.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||5.10|-6.19|0.8409
71796510|NCT04206293|143091968|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|3.98||0.9183|TWO_SIDED|95.0|-9.18|8.35|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||8.35|-9.18|0.9183
71796511|NCT04206293|143091969|SUPERIORITY||LS Mean Difference|70.0|STANDARD_ERROR_OF_MEAN|77.0||0.4128|TWO_SIDED|95.0|-142.0|282.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||282|-142|0.4128
71796512|NCT04206293|143091969|SUPERIORITY||LS Mean Difference|-82.0|STANDARD_ERROR_OF_MEAN|79.0||0.3851|TWO_SIDED|95.0|-355.0|191.0|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||191|-355|0.3851
71796513|NCT04206293|143091970|SUPERIORITY||LS Mean Difference|6.52|STANDARD_ERROR_OF_MEAN|3.44||0.0798|TWO_SIDED|95.0|-0.89|13.93|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||13.93|-0.89|0.0798
71796514|NCT04206293|143091970|SUPERIORITY||LS Mean Difference|5.56|STANDARD_ERROR_OF_MEAN|3.27||0.1142|TWO_SIDED|95.0|-1.55|12.67|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||12.67|-1.55|0.1142
71796515|NCT04206293|143091971|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.82||0.2592|TWO_SIDED|95.0|-0.78|2.71|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 28||2.71|-0.78|0.2592
71796516|NCT04206293|143091971|SUPERIORITY||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.69||0.1341|TWO_SIDED|95.0|-0.38|2.57|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Ra: Change from Baseline to Day 84||2.57|-0.38|0.1341
71796517|NCT04206293|143091971|SUPERIORITY||LS Mean Difference|5.91|STANDARD_ERROR_OF_MEAN|4.55||0.2138|TWO_SIDED|95.0|-3.79|15.61|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 28||15.61|-3.79|0.2138
71796518|NCT04206293|143091971|SUPERIORITY||LS Mean Difference|8.22|STANDARD_ERROR_OF_MEAN|4.2||0.07|TWO_SIDED|95.0|-0.77|17.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Rz: Change from Baseline to Day 84||17.20|-0.77|0.0700
71796519|NCT04206293|143091972|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|2.17||0.9608|TWO_SIDED|95.0|-4.7|4.91|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||4.91|-4.70|0.9608
71796520|NCT04206293|143091972|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|2.79||0.6192|TWO_SIDED|95.0|-7.48|4.64|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||4.64|-7.48|0.6192
71796521|NCT04206293|143091973|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.08||0.8322|TWO_SIDED|95.0|-0.2|0.16|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.16|-0.20|0.8322
71796522|NCT04206293|143091973|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07||0.1334|TWO_SIDED|95.0|-0.25|0.04|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.04|-0.25|0.1334
71796523|NCT04206293|143091974|SUPERIORITY||LS Mean Difference|-5.09|STANDARD_ERROR_OF_MEAN|7.78||0.5221|TWO_SIDED|95.0|-21.56|11.38|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||11.38|-21.56|0.5221
71796524|NCT04206293|143091974|SUPERIORITY||LS Mean Difference|6.74|STANDARD_ERROR_OF_MEAN|8.07||0.4174|TWO_SIDED|95.0|-10.55|24.03|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||24.03|-10.55|0.4174
71796525|NCT04206293|143091975|SUPERIORITY||LS Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|2.58||0.3052|TWO_SIDED|95.0|-2.9|8.44|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||8.44|-2.90|0.3052
71796526|NCT04206293|143091975|SUPERIORITY||LS Mean Difference|9.99|STANDARD_ERROR_OF_MEAN|2.57||0.0016|TWO_SIDED|95.0|4.48|15.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||15.50|4.48|0.0016
71796527|NCT04206293|143091976|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.48||0.1672|TWO_SIDED|95.0|-0.33|1.73|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.73|-0.33|0.1672
71796528|NCT04206293|143091976|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.29||0.0881|TWO_SIDED|95.0|-0.1|1.21|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.21|-0.10|0.0881
71796529|NCT04206293|143091977|SUPERIORITY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|0.28||0.0577|TWO_SIDED|95.0|-0.02|1.17|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||1.17|-0.02|0.0577
71796530|NCT04206293|143091977|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5224|TWO_SIDED|95.0|-0.85|0.45|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.45|-0.85|0.5224
71673740|NCT02347774|142865818|SUPERIORITY||Least Mean Squared (SE)|0.084|STANDARD_ERROR_OF_MEAN|0.02069||0.0001|TWO_SIDED|95.0|0.0433|0.1246||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1246|0.0433|0.0001
71673741|NCT00921557|142865833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 24||||<0.001
71673742|NCT00921557|142865833|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 48||||<0.001
71796531|NCT04206293|143091978|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2666|TWO_SIDED|95.0|-0.6|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.2|-0.6|0.2666
71796532|NCT04206293|143091978|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4366|TWO_SIDED|95.0|-0.3|0.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||0.7|-0.3|0.4366
71840262|NCT03701763|143189838|SUPERIORITY||Percentage Adjusted Difference|21.7|||<|0.0001|TWO_SIDED|95.0|11.2|32.1|||Cochran-Mantel-Haenszel|||||32.1|11.2|<0.0001
71840263|NCT03701763|143189839|SUPERIORITY||Percentage Adjusted Difference|29.4|||<|0.0001|TWO_SIDED|95.0|17.8|40.9|||Cochran-Mantel-Haenszel|||||40.9|17.8|<0.0001
71840264|NCT03701763|143189840|SUPERIORITY||Percentage Adjusted Difference|38.4|||<|0.0001|TWO_SIDED|95.0|25.6|51.2|||Cochran-Mantel-Haenszel|||||51.2|25.6|<0.0001
71796533|NCT04206293|143091979|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4197|TWO_SIDED|95.0|-0.6|0.3|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 28||0.3|-0.6|0.4197
71893229|NCT04321343|143307557|SUPERIORITY||Mean Difference (Final Values)|-21.003|STANDARD_ERROR_OF_MEAN|9.287||0.0237|TWO_SIDED|95.0|-39.2074|-2.7991|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-2.7991|-39.2074|0.0237
71673743|NCT00921557|142865834|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||||||Not adjusted for multiple comparisons|Fisher Exact|||Comparison of percentage of participants experiencing primary safety outcome||||>0.99
71796534|NCT04206293|143091979|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.914|TWO_SIDED|95.0|-0.6|0.5|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||a\*: Change from Baseline to Day 84||0.5|-0.6|0.9140
71796535|NCT04206293|143091979|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7604|TWO_SIDED|95.0|-0.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 28||0.4|-0.6|0.7604
71796536|NCT04206293|143091979|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5936|TWO_SIDED|95.0|-1.0|0.6|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||b\*: Change from Baseline to Day 84||0.6|-1.0|0.5936
71796537|NCT04206293|143091979|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0808|TWO_SIDED|95.0|-0.9|0.1|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 28||0.1|-0.9|0.0808
71840265|NCT03701763|143189841|SUPERIORITY||Difference in Least Squares Mean|-26.97|STANDARD_ERROR_OF_MEAN|4.572|<|0.0001|TWO_SIDED|95.0|-35.93|-18.0|||ANCOVA|||||-18.00|-35.93|<0.0001
71840266|NCT03701763|143189842|SUPERIORITY||Difference in Least Squares Mean|-34.77|STANDARD_ERROR_OF_MEAN|6.229|<|0.0001|TWO_SIDED|95.0|-46.99|-22.55|||ANCOVA|||||-22.55|-46.99|< 0.0001
71840267|NCT03701763|143189843|SUPERIORITY||Percentage Adjusted Difference|4.1||||0.5616|TWO_SIDED|95.0|-9.8|18.0|||Cochran-Mantel-Haenszel|||||18.0|-9.8|0.5616
71893230|NCT04321343|143307557|SUPERIORITY||Mean Difference (Final Values)|-23.748|STANDARD_ERROR_OF_MEAN|9.053||0.0087|TWO_SIDED|95.0|-41.4923|-6.0035|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-6.0035|-41.4923|0.0087
71673744|NCT01757184|142865958|SUPERIORITY|||||||0.0271|||||||Fisher Exact|Fisher's exact test at α=0.05.||A sample size of 50 randomized participants (approximately 25 participants per treatment group) provided 97% power to detect a statistically significant difference between sebelipase alfa and placebo, using Fisher's exact test at α=0.05.||||0.0271
71673745|NCT01757184|142865959|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71796538|NCT04206293|143091979|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1633|TWO_SIDED|95.0|-1.0|0.2|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||L\*: Change from Baseline to Day 84||0.2|-1.0|0.1633
71796539|NCT04206293|143091980|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1977|TWO_SIDED|95.0|-1.6|0.4|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||0.4|-1.6|0.1977
71796540|NCT04206293|143091980|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.9||0.7535|TWO_SIDED|95.0|-2.2|1.7|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||1.7|-2.2|0.7535
71796541|NCT04206293|143091981|SUPERIORITY||LS Mean Difference|4.35|STANDARD_ERROR_OF_MEAN|3.95||0.2905|TWO_SIDED|95.0|-4.16|12.85|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 28||12.85|-4.16|0.2905
71796542|NCT04206293|143091981|SUPERIORITY||LS Mean Difference|17.27|STANDARD_ERROR_OF_MEAN|6.37||0.0241|TWO_SIDED|95.0|2.84|31.69|||Mixed ANOVA|Mixed ANOVA model was used for repeated measures with factors: Zone as fixed(treated,control),time as fixed(D0,D28,D84),zone by time interaction.||Change from Baseline to Day 84||31.69|2.84|0.0241
71796543|NCT01454934|143091991|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.16||||0.1343|TWO_SIDED|95.0|0.95|1.41||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.41|0.95|0.1343
71796544|NCT01454934|143091992|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.09||||0.3946|TWO_SIDED|95.0|0.9|1.32||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||1.32|0.90|0.3946
71796545|NCT01454934|143091993|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3034||||||The P-value was stratified by histology, TPC option, and geographic region.|Cochran-Mantel-Haenszel|||OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).||||0.3034
71796546|NCT00782210|143092035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.135|<0.0001
71796547|NCT00782210|143092035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.214|0.139|<0.0001
71796548|NCT00782210|143092036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.128|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.128|0.054|<0.0001
71796549|NCT00782210|143092036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|0.064|<0.0001
71796550|NCT00782210|143092037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.113|0.233|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.233|0.113|<0.0001
71796551|NCT00782210|143092037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.108|0.229|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.229|0.108|<0.0001
71796552|NCT00782210|143092038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
71796553|NCT00782210|143092038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.139|<0.0001
71673746|NCT01757184|142865960|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71673747|NCT01757184|142865961|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||||||0.0003
71840268|NCT03701763|143189844|SUPERIORITY||Difference in Least Squares Mean|-1.8||||0.0009|TWO_SIDED|95.0|-2.9|-0.8|||ANCOVA|||||-0.8|-2.9|0.0009
71840269|NCT03785964|143189875|SUPERIORITY||Hazard Ratio (HR)|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.55|||Log Rank|p-value was from a one-sided stratified log-rank test with placebo as reference.||Hazard ratio was estimated from stratified Cox proportional hazards model using the exact method for ties, stratified by tumor location. Placebo was the reference treatment.||0.55|0.15|< 0.001
71840270|NCT03785964|143189876|SUPERIORITY||||||<|0.001||||||Two-sided p-value|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.||||< 0.001
71840271|NCT03785964|143189877|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline Brief Pain Inventory Short Form score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 31 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
71840272|NCT03785964|143189878|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline DEsmoid Tumor Symptom Scale score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 40 and 32 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
71840273|NCT03785964|143189879|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 39 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
71893231|NCT04321343|143307558|SUPERIORITY||Hodges-Lehmann midpoint estimate|-26.226|STANDARD_ERROR_OF_MEAN|10.252||0.0105|TWO_SIDED|95.0|-46.3208|-6.1313|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-6.1313|-46.3208|0.0105
71893232|NCT04321343|143307558|SUPERIORITY||Hodges-Lehmann midpoint estimate|-21.496|STANDARD_ERROR_OF_MEAN|9.873||0.0295|TWO_SIDED|95.0|-40.8475|-2.1451|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-2.1451|-40.8475|0.0295
71893233|NCT04321343|143307558|SUPERIORITY||Hodges-Lehmann midpoint estimate|-24.29|STANDARD_ERROR_OF_MEAN|9.746||0.0127|TWO_SIDED|95.0|-43.392|-5.1884|||Wilcoxon (Mann-Whitney)|Non-parametric pairwaise Wilcoxon tests using a multiple imputation procedure based on the fully conditional specification method.||||-5.1884|-43.3920|0.0127
71893234|NCT04321343|143307559|SUPERIORITY||Mean Difference (Final Values)|-4.671|STANDARD_ERROR_OF_MEAN|1.824||0.0105|TWO_SIDED|95.0|-8.2463|-1.0957|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0957|-8.2463|0.0105
71673748|NCT01757184|142865962|SUPERIORITY|||||||0.0375|||||||Wilcoxon (Mann-Whitney)|||||||0.0375
71840274|NCT03785964|143189880|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 27 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||0.006
71840275|NCT03785964|143189881|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
71840276|NCT03785964|143189882|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|An unstructured covariance structure was used and degrees of freedom were estimated using the Kenward-Roger approximation.||Mixed model with repeated measures (MMRM) with treatment and visit as factors, Baseline score and primary tumor location (intra-abdominal or extra-abdominal) as covariates, included baseline by visit and treatment by visit interactions. Only participants with a Baseline and at least one post-baseline score were included in the analysis. 38 and 28 participants contributed to this analysis at Cycle 10 from Nirogacestat and Placebo respectively.||||<0.001
71840277|NCT04117347|143189883|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.022|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.0861723|0.1309519|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for left amygdala.||0.1309519|-0.0861723|
71840278|NCT04117347|143189883|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.068|STANDARD_ERROR_OF_MEAN|0.052|||TWO_SIDED|95.0|-0.0363877|0.1730965|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for left amygdala.||0.1730965|-0.0363877|
71673749|NCT01757184|142865963|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71673750|NCT01757184|142865964|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71673751|NCT01757184|142865965|SUPERIORITY|||||||0.4216|||||||Fisher Exact|||||||0.4216
71673752|NCT01757184|142865966|SUPERIORITY|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
71796554|NCT00782210|143092039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.144|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.144|<0.0001
71796555|NCT00782210|143092039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.156|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.156|<0.0001
71796556|NCT00782210|143092040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.133|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.207|0.133|<0.0001
71796557|NCT00782210|143092040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.13|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.130|<0.0001
71796558|NCT00782210|143092041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.136|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.136|<0.0001
71796559|NCT00782210|143092041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.123|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.199|0.123|<0.0001
71796560|NCT00782210|143092042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.134|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.134|<0.0001
71796561|NCT00782210|143092042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.208|0.131|<0.0001
71796562|NCT00782210|143092043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
71796563|NCT00782210|143092043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.075|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.147|0.075|<0.0001
71796564|NCT00782210|143092044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|0.059|<0.0001
71796565|NCT00782210|143092044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.127|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.127|0.054|<0.0001
71796566|NCT00782210|143092045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.061|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.135|0.061|<0.0001
71796567|NCT00782210|143092045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.064|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|0.064|<0.0001
71796568|NCT00782210|143092046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.049|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.049|<0.0001
71796569|NCT00782210|143092046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.051|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.126|0.051|<0.0001
71796570|NCT00782210|143092047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.054|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.054|<0.0001
71796571|NCT00782210|143092047|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.048|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.123|0.048|<0.0001
71796572|NCT00782210|143092048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.069|0.145|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.145|0.069|<0.0001
71796573|NCT00782210|143092048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.068|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|0.068|<0.0001
71673753|NCT02977572|142865968|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Based upon previous results, the investigators considered that the need for an intubation could be reduced by 15% \[19% in the CPAP group (control) vs. 4% in the NIV group (study)\]. The estimated sample size was 55 participants in each group (confidence interval \[1-α\] = 90% and power \[1-β\] = 85%).||||1.000
71893235|NCT04321343|143307559|SUPERIORITY||Mean Difference (Final Values)|-4.097|STANDARD_ERROR_OF_MEAN|1.743||0.0188|TWO_SIDED|95.0|-7.514|-0.6799|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-0.6799|-7.5140|0.0188
71673754|NCT01197534|142866006|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
71673755|NCT01197534|142866007|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.08|||<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.04|<0.001
71796574|NCT00782210|143092049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.055|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.130|0.055|<0.0001
71796575|NCT00782210|143092049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.053|0.129|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.129|0.053|<0.0001
71796576|NCT00782210|143092050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.115|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.194|0.115|<0.0001
71796577|NCT00782210|143092050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.131|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.131|<0.0001
71796578|NCT00782210|143092051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.137|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.137|<0.0001
71796579|NCT00782210|143092051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.15|0.23|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.230|0.150|<0.0001
71796580|NCT00782210|143092052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.212|0.132|<0.0001
71796581|NCT00782210|143092052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.132|<0.0001
71796582|NCT00782210|143092053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.123|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.204|0.123|<0.0001
71796583|NCT00782210|143092053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
71796584|NCT00782210|143092054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.134|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.216|0.134|<0.0001
71796585|NCT00782210|143092054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.192|0.110|<0.0001
71796586|NCT00782210|143092055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.128|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.211|0.128|<0.0001
71796587|NCT00782210|143092055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.121|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.205|0.121|<0.0001
71893236|NCT04321343|143307559|SUPERIORITY||Mean Difference (Final Values)|-4.321|STANDARD_ERROR_OF_MEAN|1.689||0.0105|TWO_SIDED|95.0|-7.6307|-1.0104|||ANCOVA|ANCOVA model using a multiple imputation procedure based on the fully conditional specification method.|Mean difference (final values) is the difference in Least Squares (LS) Means estimated in the ANCOVA model.|||-1.0104|-7.6307|0.0105
71673756|NCT01197534|142866008|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.13|||<|0.001|TWO_SIDED|95.0|0.07|0.18|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.07|<0.001
71673757|NCT01197534|142866008|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.15|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.15|0.05|<0.001
71673758|NCT01197534|142866009|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.07|||<|0.001|TWO_SIDED|95.0|0.03|0.1|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.10|0.03|<0.001
71673759|NCT01197534|142866009|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.033|TWO_SIDED|95.0|0.0|0.07|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.00|0.033
71673760|NCT01197534|142866010|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
71796588|NCT00782210|143092056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.288|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.216|0.359|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.359|0.216|<0.0001
71796589|NCT00782210|143092056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.258|0.401|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.401|0.258|<0.0001
71796590|NCT00782210|143092057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.296|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.224|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.368|0.224|<0.0001
71796591|NCT00782210|143092057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.327|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.255|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.399|0.255|<0.0001
71796592|NCT00782210|143092058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.181|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.181|<0.0001
71796593|NCT00782210|143092058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.22|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.220|<0.0001
71796594|NCT00782210|143092059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.275|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.201|0.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.348|0.201|<0.0001
71840279|NCT04117347|143189883|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.043|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.0676154|0.1545869|||||coefficient for an indicator for Light Therapy B (vs. Light Therapy A)|Analysis for right amygdala.||0.1545869|-0.0676154|
71840280|NCT04117347|143189883|OTHER|Dose Response Relationship.|Coefficient for an indicator|0.018|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.0888691|0.1255146|||||coefficient for an indicator for Light Therapy C (vs. Light Therapy A)|Analysis for right amygdala.||0.1255146|-0.0888691|
71796595|NCT00782210|143092059|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.219|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.366|0.219|<0.0001
71796596|NCT00782210|143092060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.309|0.161|<0.0001
71796597|NCT00782210|143092060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.18|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.180|<0.0001
71840281|NCT02505984|143189884|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71840282|NCT02505984|143189884|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
71840283|NCT02505984|143189884|SUPERIORITY|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
71840284|NCT02505984|143189884|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71673761|NCT01197534|142866010|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
71673762|NCT01197534|142866011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|3.42|14.8|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.80|3.42|<0.001
71840285|NCT02505984|143189885|SUPERIORITY||||||>|0.9|||||||Wilcoxon (Mann-Whitney)|||||||>0.9
71840286|NCT02505984|143189885|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71840287|NCT02505984|143189886|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71840288|NCT02505984|143189886|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71840289|NCT02505984|143189887|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.7
71673763|NCT01197534|142866011|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0|||<|0.001|TWO_SIDED|95.0|1.88|8.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||8.65|1.88|<0.001
71796598|NCT00782210|143092061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.169|0.319|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.319|0.169|<0.0001
71796599|NCT00782210|143092061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.271|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.196|0.346|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.346|0.196|<0.0001
71796600|NCT00782210|143092062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.076|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.218|0.076|<0.0001
71796601|NCT00782210|143092062|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.113|0.255|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.255|0.113|<0.0001
71796602|NCT00782210|143092063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.059|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.059|0.0003
71796603|NCT00782210|143092063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.036||0.0001||95.0|0.069|0.213|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.213|0.069|0.0001
71796604|NCT00782210|143092064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.037||0.0019||95.0|0.043|0.187|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.187|0.043|0.0019
71840290|NCT02505984|143189887|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71840291|NCT02505984|143189887|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71840292|NCT05194956|143189888|SUPERIORITY||Mean Difference (Net)|8.5||||0.0006|TWO_SIDED|95.0|3.75|13.15|||Two-period two-treatment crossover ANOVA|P-values are calculated taking sequence and period effects into account.|This estimation value assumes period and sequence effects are equal between the treatments.|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)||13.15|3.75|0.0006
71840293|NCT05194956|143189888|SUPERIORITY|Sequence effects||||||0.1984|||||||ANOVA|||||||0.1984
71840294|NCT05194956|143189888|SUPERIORITY|Period effects||||||0.7494|||||||ANOVA|||||||0.7494
71796605|NCT00782210|143092064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.088|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.233|0.088|<0.0001
71796606|NCT00782210|143092065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.037||0.0005||95.0|0.057|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.057|0.0005
71796607|NCT00782210|143092065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.089|0.235|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.235|0.089|<0.0001
71796608|NCT00782210|143092066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.037||0.0261||95.0|0.01|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.156|0.010|0.0261
71673764|NCT01197534|142866012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.3|||<|0.001|TWO_SIDED|95.0|3.23|16.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||16.65|3.23|<0.001
71673765|NCT01197534|142866012|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.81|14.71|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.71|2.81|<0.001
71758481|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.51|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|0.51|<0.0001
71840295|NCT05194956|143189888|SUPERIORITY|Mixed effects modelling|Mean Difference (Net)|-13.31||||0.001|TWO_SIDED|95.0|-21.29|-5.33|||Mixed Models Analysis|||||-5.33|-21.29|0.001
71840296|NCT05194956|143189889|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.123|TWO_SIDED|95.0|-7.71|0.91||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.91|-7.71|0.1230
71758482|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.64|||<|0.0001|TWO_SIDED|95.0|0.41|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.86|0.41|<0.0001
71840297|NCT05194956|143189889|SUPERIORITY|Sequence effects||||||0.8423|||||||ANOVA|||||||0.8423
71840298|NCT05194956|143189889|SUPERIORITY|Period effects||||||0.9544|||||||ANOVA|||||||0.9544
71758483|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.74|||<|0.0001|TWO_SIDED|95.0|0.49|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.99|0.49|<0.0001
71758484|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.42||||0.001|TWO_SIDED|95.0|0.17|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|0.17|0.0010
71758485|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.32|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|0.32|<0.0001
71758486|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.52||||0.0005|TWO_SIDED|95.0|0.23|0.82|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.82|0.23|0.0005
71758487|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.56||||0.0008|TWO_SIDED|95.0|0.23|0.88|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.88|0.23|0.0008
71758488|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.33||||0.0591|TWO_SIDED|95.0|-0.01|0.67|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.67|-0.01|0.0591
71758489|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.67||||0.0005|TWO_SIDED|95.0|0.29|1.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.05|0.29|0.0005
71673766|NCT01197534|142866013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|2.06|3.91||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.91|2.06|<0.001
71758490|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.3||||0.1378|TWO_SIDED|95.0|-0.09|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.68|-0.09|0.1378
71840299|NCT05194956|143189890|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-3.4||||0.0439|TWO_SIDED|95.0|-6.69|-0.12||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-0.12|-6.69|0.0439
71840300|NCT05194956|143189890|SUPERIORITY|Sequence effects||||||0.3878|||||||ANOVA|||||||0.3878
71840301|NCT05194956|143189890|SUPERIORITY|Period effects||||||0.9772|||||||ANOVA|||||||0.9772
71840302|NCT05194956|143189891|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|9.6||||0.0213|TWO_SIDED|95.0|1.5|17.79||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||17.79|1.50|0.0213
71840303|NCT05194956|143189891|SUPERIORITY|Sequence effects||||||0.1583|||||||ANOVA|||||||0.1583
71840304|NCT05194956|143189891|SUPERIORITY|Period effects||||||0.4709|||||||ANOVA|||||||0.4709
71840305|NCT05194956|143189892|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|5.3||||0.0146|TWO_SIDED|95.0|1.09|9.46||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||9.46|1.09|0.0146
71840306|NCT05194956|143189892|SUPERIORITY|Sequence effects||||||0.5911|||||||ANOVA|||||||0.5911
71840307|NCT05194956|143189892|SUPERIORITY|Period effects||||||0.5825|||||||ANOVA|||||||0.5825
71840308|NCT05194956|143189893|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-5.2||||0.0817|TWO_SIDED|95.0|-11.12|0.69||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-11.12|0.0817
71840309|NCT05194956|143189893|SUPERIORITY|Sequence effects||||||0.091|||||||ANOVA|||||||0.0910
71758491|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.43||||0.065|TWO_SIDED|95.0|-0.03|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.89|-0.03|0.0650
71758492|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.48||||0.0531|TWO_SIDED|95.0|-0.01|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||0.96|-0.01|0.0531
71840310|NCT05194956|143189893|SUPERIORITY|Period effects||||||0.2278|||||||ANOVA|||||||0.2278
71758493|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.93||||0.0011|TWO_SIDED|95.0|0.37|1.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.49|0.37|0.0011
71840311|NCT05194956|143189894|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-2.2||||0.1347|TWO_SIDED|95.0|-5.17|0.69|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||0.69|-5.17|0.1347
71840312|NCT05194956|143189894|SUPERIORITY|Sequence effects||||||0.9259|||||||ANOVA|||||||0.9259
71840313|NCT05194956|143189894|SUPERIORITY|Period effects||||||0.8225|||||||ANOVA|||||||0.8225
71758494|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.55||||0.0708|TWO_SIDED|95.0|-0.05|1.14|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.14|-0.05|0.0708
71893237|NCT04321343|143307560|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1634|TWO_SIDED|95.0|0.677|10.087|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||10.087|0.677|0.1634
71893238|NCT04321343|143307560|SUPERIORITY||Odds Ratio (OR)|3.26||||0.0722|TWO_SIDED|95.0|0.899|11.831|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.831|0.899|0.0722
71893239|NCT04321343|143307560|SUPERIORITY||Odds Ratio (OR)|3.17||||0.0703|TWO_SIDED|95.0|0.909|11.052|||Cochran-Mantel-Haenszel|CMH with multiple imputation||||11.052|0.909|0.0703
71796609|NCT00782210|143092066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.05|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.050|0.0010
71796610|NCT00782210|143092067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.038||0.0154||95.0|0.018|0.165|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.165|0.018|0.0154
71796611|NCT00782210|143092067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.038||0.0011||95.0|0.049|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.197|0.049|0.0011
71893240|NCT04321343|143307561|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|8.2||0.4318|TWO_SIDED|95.0|-22.66|9.72|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||9.72|-22.66|0.4318
71796612|NCT00782210|143092068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.038||0.0006||95.0|0.057|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.205|0.057|0.0006
71796613|NCT00782210|143092068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.08|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.229|0.080|<0.0001
71796614|NCT00782210|143092069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.038||0.0134||95.0|0.019|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.168|0.019|0.0134
71796615|NCT00782210|143092069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.038||0.0025||95.0|0.04|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.040|0.0025
71796616|NCT00782210|143092070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.187|0.339|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.339|0.187|<0.0001
71796617|NCT00782210|143092070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.225|0.376|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.376|0.225|<0.0001
71796618|NCT00782210|143092071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.188|0.341|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.341|0.188|<0.0001
71796619|NCT00782210|143092071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.216|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.368|0.216|<0.0001
71796620|NCT00782210|143092072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.174|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.328|0.174|<0.0001
71796621|NCT00782210|143092072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.203|0.358|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.358|0.203|<0.0001
71796622|NCT00782210|143092073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.174|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.329|0.174|<0.0001
71796623|NCT00782210|143092073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.183|0.338|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.338|0.183|<0.0001
71893241|NCT04321343|143307561|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|8.0||0.8382|TWO_SIDED|95.0|-17.37|14.1|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.10|-17.37|0.8382
71893242|NCT04321343|143307561|SUPERIORITY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.7||0.4982|TWO_SIDED|95.0|-9.92|20.33|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||20.33|-9.92|0.4982
71893243|NCT04321343|143307562|SUPERIORITY||Odds Ratio (OR)|0.72||||0.7137|TWO_SIDED|95.0|0.131|3.935|||Cochran-Mantel-Haenszel|||||3.935|0.131|0.7137
71893244|NCT04321343|143307562|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0597|TWO_SIDED|95.0|0.937|14.58|||Cochran-Mantel-Haenszel|||||14.580|0.937|0.0597
71893245|NCT04321343|143307562|SUPERIORITY||Odds Ratio (OR)|2.61||||0.1749|TWO_SIDED|95.0|0.655|10.43|||Cochran-Mantel-Haenszel|||||10.430|0.655|0.1749
71893246|NCT04321343|143307563|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|8.8||0.7449|TWO_SIDED|95.0|-20.15|14.43|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||14.43|-20.15|0.7449
71893247|NCT04321343|143307563|SUPERIORITY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|8.6||0.7255|TWO_SIDED|95.0|-19.93|13.9|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||13.90|-19.93|0.7255
71673767|NCT01197534|142866013|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.77|3.37||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio \> 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.37|1.77|<0.001
71796624|NCT00782210|143092074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.153|<0.0001
71796625|NCT00782210|143092074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.154|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.311|0.154|<0.0001
71796626|NCT00782210|143092075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.247|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.168|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.327|0.168|<0.0001
71796627|NCT00782210|143092075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.181|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.340|0.181|<0.0001
71796628|NCT00782210|143092076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.181|0.422|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.422|0.181|<0.0001
71796629|NCT00782210|143092076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001||95.0|0.128|0.37|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.370|0.128|<0.0001
71796630|NCT00782210|143092077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.357|STANDARD_ERROR_OF_MEAN|4.253||0.0018|TWO_SIDED|95.0|5.005|21.709|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||21.709|5.005|0.0018
71796631|NCT00782210|143092077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.457|STANDARD_ERROR_OF_MEAN|4.248||0.0003|TWO_SIDED|95.0|7.114|23.8|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||23.800|7.114|0.0003
71796632|NCT00782210|143092078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.186|STANDARD_ERROR_OF_MEAN|4.245|<|0.0001|TWO_SIDED|95.0|8.849|25.523|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||25.523|8.849|<0.0001
71796633|NCT00782210|143092078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.56|STANDARD_ERROR_OF_MEAN|4.226||0.0006|TWO_SIDED|95.0|6.259|22.86|||ANCOVA|non-MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.||||22.860|6.259|0.0006
71796634|NCT00782210|143092079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.182||0.0045|TWO_SIDED|95.0|-0.878|-0.162|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.162|-0.878|0.0045
71796635|NCT00782210|143092079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.182||0.0004|TWO_SIDED|95.0|-1.005|-0.291|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.291|-1.005|0.0004
71796636|NCT00782210|143092080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.582|STANDARD_ERROR_OF_MEAN|0.202||0.0041|TWO_SIDED|95.0|-0.979|-0.185|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.185|-0.979|0.0041
71796637|NCT00782210|143092080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|0.202||0.0001|TWO_SIDED|95.0|-1.189|-0.394|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.394|-1.189|0.0001
71796638|NCT00782210|143092081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.104|STANDARD_ERROR_OF_MEAN|0.354||0.0019|TWO_SIDED|95.0|-1.799|-0.409|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.409|-1.799|0.0019
71796639|NCT00782210|143092081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.435|STANDARD_ERROR_OF_MEAN|0.354|<|0.0001|TWO_SIDED|95.0|-2.13|-0.74|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.740|-2.130|<0.0001
71796640|NCT00782210|143092082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
71796641|NCT00782210|143092082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.3|-0.7|<0.0001
71796642|NCT00782210|143092083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
71893248|NCT04321343|143307563|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|8.2||0.7755|TWO_SIDED|95.0|-13.89|18.59|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||18.59|-13.89|0.7755
71796643|NCT00782210|143092083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
71893249|NCT04321343|143307564|SUPERIORITY||Odds Ratio (OR)|3.12||||0.1325|TWO_SIDED|95.0|0.703|13.806|||Cochran-Mantel-Haenszel|||||13.806|0.703|0.1325
71893250|NCT04321343|143307564|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9918|TWO_SIDED|95.0|0.201|4.898|||Cochran-Mantel-Haenszel|||||4.898|0.201|0.9918
71893251|NCT04321343|143307564|SUPERIORITY||Odds Ratio (OR)|4.78||||0.041|TWO_SIDED|95.0|1.053|21.714|||Cochran-Mantel-Haenszel|||||21.714|1.053|0.0410
71796644|NCT00782210|143092084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
71796645|NCT00782210|143092084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.2|-0.7|<0.0001
71796646|NCT00782210|143092085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0109||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0109
71796647|NCT00782210|143092085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0031||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0031
71796648|NCT00782210|143092086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.728|STANDARD_ERROR_OF_MEAN|0.124||0.0658|TWO_SIDED|95.0|0.522|1.016|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.016|0.522|0.0658
71796649|NCT00782210|143092086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799|STANDARD_ERROR_OF_MEAN|0.133||0.1701|TWO_SIDED|95.0|0.576|1.107|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.107|0.576|0.1701
71796650|NCT00782210|143092087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.656|STANDARD_ERROR_OF_MEAN|0.247||0.2754|TWO_SIDED|95.0|0.313|1.374|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.374|0.313|0.2754
71796651|NCT00782210|143092087|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.342||0.9792|TWO_SIDED|95.0|0.521|1.961|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.961|0.521|0.9792
71893252|NCT04321343|143307565|SUPERIORITY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|10.3||0.4413|TWO_SIDED|95.0|-28.25|12.36|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||12.36|-28.25|0.4413
71893253|NCT04321343|143307565|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.2||0.0859|TWO_SIDED|95.0|-37.63|2.5|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.50|-37.63|0.0859
71796652|NCT00782210|143092088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739|STANDARD_ERROR_OF_MEAN|0.142||0.1194|TWO_SIDED|95.0|0.506|1.078|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.078|0.506|0.1194
71796653|NCT00782210|143092088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811|STANDARD_ERROR_OF_MEAN|0.153||0.257|TWO_SIDED|95.0|0.561|1.174|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.174|0.561|0.2570
71796654|NCT00782210|143092089|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.7815|STANDARD_ERROR_OF_MEAN|0.138||0.1631|TWO_SIDED|95.0|0.5524|1.1054|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.1054|0.5524|0.1631
71796655|NCT00782210|143092089|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8456|STANDARD_ERROR_OF_MEAN|0.1467||0.3342|TWO_SIDED|95.0|0.6015|1.1889|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.1889|0.6015|0.3342
71796656|NCT00782210|143092090|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.655|STANDARD_ERROR_OF_MEAN|0.2664||0.2985|TWO_SIDED|95.0|0.2947|1.4556|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.4556|0.2947|0.2985
71796657|NCT00782210|143092090|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1211|STANDARD_ERROR_OF_MEAN|0.4103||0.755|TWO_SIDED|95.0|0.5464|2.3003|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.3003|0.5464|0.7550
71893254|NCT04321343|143307565|SUPERIORITY||Median Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|10.0||0.7887|TWO_SIDED|95.0|-22.31|16.97|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||16.97|-22.31|0.7887
71893255|NCT04321343|143307566|SUPERIORITY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|3.7||0.1166|TWO_SIDED|95.0|-13.19|1.47|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.47|-13.19|0.1166
71893256|NCT04321343|143307566|SUPERIORITY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|3.7||0.003|TWO_SIDED|95.0|-18.26|-3.8|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-3.80|-18.26|0.0030
71893257|NCT04321343|143307566|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|3.5||0.0131|TWO_SIDED|95.0|-15.79|-1.87|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-1.87|-15.79|0.0131
71673768|NCT01197534|142866014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.73|3.46|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.46|1.73|<0.001
71796658|NCT00782210|143092091|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8081|STANDARD_ERROR_OF_MEAN|0.163||0.2911|TWO_SIDED|95.0|0.5438|1.2008|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.2008|0.5438|0.2911
71796659|NCT00782210|143092091|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8485|STANDARD_ERROR_OF_MEAN|0.1686||0.4086|TWO_SIDED|95.0|0.5743|1.2535|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.2535|0.5743|0.4086
71796660|NCT01675882|143092148|SUPERIORITY||Relative risk|1.81||||0.0292|TWO_SIDED|95.0|1.05|3.11|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05. Thus, no conclusion can be made on the comparison of viaskin peanut 50 µg vs placebo.||3.11|1.05|0.0292
71796661|NCT01675882|143092148|SUPERIORITY||Relative risk|1.64||||0.1074|TWO_SIDED|95.0|0.95|2.85|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05. The subsequent comparison of viaskin peanut 100 µg versus placebo is not statistically significant at p\<0.05.||2.85|0.95|0.1074
71796662|NCT01675882|143092148|SUPERIORITY||Relative risk|2.0||||0.0108|TWO_SIDED|95.0|1.18|3.38|||Fisher Exact|||The three pair-wise comparisons of viaskin peanut versus placebo were analyzed using the Bonferroni stepwise procedure, keeping the overall false-positive (alpha) risk below 5%. The comparison of viaskin peanut 250 µg versus placebo is statistically significant at p\<0.05.||3.38|1.18|0.0108
71796663|NCT01675882|143092149|SUPERIORITY||Relative risk|2.95||||0.0035|TWO_SIDED|95.0|1.34|6.49|||Fisher Exact|||||6.49|1.34|0.0035
71796664|NCT01675882|143092149|SUPERIORITY||Relative risk|2.38||||0.0453|TWO_SIDED|95.0|1.04|5.47|||Fisher Exact|||||5.47|1.04|0.0453
71796665|NCT01675882|143092149|SUPERIORITY||Relative risk|2.77||||0.0076|TWO_SIDED|95.0|1.25|6.14|||Fisher Exact|||||6.14|1.25|0.0076
71796666|NCT01675882|143092150|SUPERIORITY||Relative risk|1.5||||0.7112|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.7112
71796667|NCT01675882|143092150|SUPERIORITY||Relative risk|0.47||||0.4048|TWO_SIDED|95.0|0.1|2.28|||Fisher Exact|||||2.28|0.10|0.4048
71796668|NCT01675882|143092150|SUPERIORITY||Relative risk|1.75||||0.4705|TWO_SIDED|95.0|0.62|4.95|||Fisher Exact|||||4.95|0.62|0.4705
71796669|NCT01675882|143092151|SUPERIORITY||Relative risk|0.5||||0.5921|TWO_SIDED|95.0|0.13|1.9|||Fisher Exact|||||1.90|0.13|0.5921
71796670|NCT01675882|143092151|SUPERIORITY||Relative risk|1.43||||0.326|TWO_SIDED|95.0|0.71|2.88|||Fisher Exact|||||2.88|0.71|0.3260
71796671|NCT01675882|143092151|SUPERIORITY||Relative risk|1.05||||1|TWO_SIDED|95.0|0.46|2.38|||Fisher Exact|||||2.38|0.46|1.0000
71796672|NCT01675882|143092152|SUPERIORITY||Difference in LS mean|70.2||||0.0607|TWO_SIDED|95.0|-2.41|193.69||P-value was based on type III sum of squares from analysis of covariance (ANCOVA) model on log transformed values for peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The least squares (LS) mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||193.69|-2.41|0.0607
71796673|NCT01675882|143092152|SUPERIORITY||Difference in LS mean|97.5||||0.015|TWO_SIDED|95.0|14.45|237.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||237.82|14.45|0.0150
71796674|NCT01675882|143092152|SUPERIORITY||Difference in LS mean|242.2|||<|0.0001|TWO_SIDED|95.0|100.03|482.65||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||482.65|100.03|<0.0001
71796675|NCT01675882|143092153|SUPERIORITY||Difference in LS mean|73.9||||0.0372|TWO_SIDED|95.0|2.96|225.85||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||225.85|2.96|0.0372
71796676|NCT01675882|143092153|SUPERIORITY||Difference in LS mean|96.7||||0.0143|TWO_SIDED|95.0|12.92|278.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||278.11|12.92|0.0143
71893258|NCT04321343|143307567|SUPERIORITY||Mean Difference (Final Values)|-1.013|STANDARD_ERROR_OF_MEAN|1.481||0.4963|TWO_SIDED|95.0|-3.9701|1.9436|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.9436|-3.9701|0.4963
71796677|NCT01675882|143092153|SUPERIORITY||Difference in LS mean|260.3|||<|0.0001|TWO_SIDED|95.0|89.83|625.95||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||625.95|89.83|<0.0001
71796678|NCT01675882|143092154|SUPERIORITY||Difference in LS mean|26.1||||0.6596|TWO_SIDED|95.0|-59.58|236.0||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||236.00|-59.58|0.6596
71796679|NCT01675882|143092154|SUPERIORITY||Difference in LS mean|8.9||||0.8702|TWO_SIDED|95.0|-65.9|189.96||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||189.96|-65.90|0.8702
71796680|NCT01675882|143092154|SUPERIORITY||Difference in LS mean|158.9||||0.063|TWO_SIDED|95.0|-5.5|562.31||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||562.31|-5.50|0.0630
71796681|NCT01675882|143092155|SUPERIORITY||Difference in LS mean|-80.2||||0.6776|TWO_SIDED|95.0|-237.22|782.24||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||782.24|-237.22|0.6776
71796682|NCT01675882|143092155|SUPERIORITY||Difference in LS mean|158.8||||0.5068|TWO_SIDED|95.0|-166.1|1478.83||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1478.83|-166.10|0.5068
71796683|NCT01675882|143092155|SUPERIORITY||Difference in LS mean|53.8||||0.7972|TWO_SIDED|95.0|-193.9|1085.38||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the peanut protein eliciting dose at Month 12, including treatment group, baseline eliciting dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean peanut protein eliciting dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1085.38|-193.90|0.7972
71893259|NCT04321343|143307567|SUPERIORITY||Mean Difference (Final Values)|-0.712|STANDARD_ERROR_OF_MEAN|1.402||0.6131|TWO_SIDED|95.0|-3.5109|2.0866|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||2.0866|-3.5109|0.6131
71893260|NCT04321343|143307567|SUPERIORITY||Mean Difference (Final Values)|-1.441|STANDARD_ERROR_OF_MEAN|1.362||0.2939|TWO_SIDED|95.0|-4.1593|1.2779|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||1.2779|-4.1593|0.2939
71893261|NCT04321343|143307568|SUPERIORITY||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.211||0.7672|TWO_SIDED|95.0|-0.4845|0.3589|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3589|-0.4845|0.7672
71796684|NCT01675882|143092156|SUPERIORITY||Difference in LS mean|120.0||||0.0444|TWO_SIDED|95.0|2.3|321.8||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||321.80|2.30|0.0444
71796685|NCT01675882|143092156|SUPERIORITY||Difference in LS mean|147.6||||0.0175|TWO_SIDED|95.0|19.67|365.51||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||365.51|19.67|0.0175
71796686|NCT01675882|143092156|SUPERIORITY||Difference in LS mean|386.0|||<|0.0001|TWO_SIDED|95.0|159.67|771.16||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the cumulative reactive dose at Month 12, including treatment group, baseline cumulative reactive dose, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean peanut protein cumulative reactive dose for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||771.16|159.67|<0.0001
71796687|NCT01675882|143092157|SUPERIORITY||Difference in LS mean|-0.6||||0.251|TWO_SIDED|95.0|-1.55|0.52||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||0.52|-1.55|0.2510
71893262|NCT04321343|143307568|SUPERIORITY||Mean Difference (Final Values)|-0.127|STANDARD_ERROR_OF_MEAN|0.198||0.5233|TWO_SIDED|95.0|-0.5216|0.2678|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2678|-0.5216|0.5233
71673769|NCT01197534|142866014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.46|2.94|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.94|1.46|<0.001
71673770|NCT01197534|142866015|SUPERIORITY_OR_OTHER|||||||0.904||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.904
71673771|NCT01197534|142866015|SUPERIORITY_OR_OTHER|||||||0.342||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.||||0.342
71796688|NCT01675882|143092157|SUPERIORITY||Difference in LS mean|-0.2||||0.682|TWO_SIDED|95.0|-1.24|1.05||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.05|-1.24|0.6820
71796689|NCT01675882|143092157|SUPERIORITY||Difference in LS mean|0.8||||0.2117|TWO_SIDED|95.0|-0.42|2.47||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the OFC symptom scores at Month 12, including treatment group, Baseline OFC symptom scores, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group is the estimated mean OFC score for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.47|-0.42|0.2117
71796690|NCT01675882|143092159|SUPERIORITY||Difference in LS mean|17.4||||0.0337|TWO_SIDED|95.0|1.17|38.82||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||38.82|1.17|0.0337
71796691|NCT01675882|143092159|SUPERIORITY||Difference in LS mean|26.2||||0.002|TWO_SIDED|95.0|8.38|49.45||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||49.45|8.38|0.0020
71840314|NCT05194956|143189895|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Median Difference (Net)|-11.2||||0.02|TWO_SIDED|95.0|-20.47|-1.83||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-1.83|-20.47|0.0200
71893263|NCT04321343|143307568|SUPERIORITY||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.18||0.1263|TWO_SIDED|95.0|-0.6376|0.0805|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0805|-0.6376|0.1263
71796692|NCT01675882|143092159|SUPERIORITY||Difference in LS mean|20.0||||0.012|TWO_SIDED|95.0|3.85|40.91||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all Baseline covariates in the analysis set.||40.91|3.85|0.0120
71796693|NCT01675882|143092163|SUPERIORITY||Difference in LS mean|1.2|||<|0.0001|TWO_SIDED|95.0|0.72|1.9||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||1.90|0.72|<0.0001
71893264|NCT04321343|143307569|SUPERIORITY||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.165||0.8662|TWO_SIDED|95.0|-0.3559|0.3002|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.3002|-0.3559|0.8662
71893265|NCT04321343|143307569|SUPERIORITY||Mean Difference (Final Values)|-0.094|STANDARD_ERROR_OF_MEAN|0.166||0.5726|TWO_SIDED|95.0|-0.4253|0.2369|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2369|-0.4253|0.5726
71840315|NCT05194956|143189895|SUPERIORITY|Sequence effects||||||0.9104|||||||ANOVA|||||||0.9104
71840316|NCT05194956|143189895|SUPERIORITY|Period effects||||||0.5194|||||||ANOVA|||||||0.5194
71893266|NCT04321343|143307569|SUPERIORITY||Mean Difference (Final Values)|-0.186|STANDARD_ERROR_OF_MEAN|0.153||0.2289|TWO_SIDED|95.0|-0.4907|0.1192|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.1192|-0.4907|0.2289
71893267|NCT04321343|143307570|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.254||0.8595|TWO_SIDED|95.0|-0.5509|0.4607|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4607|-0.5509|0.8595
71893268|NCT04321343|143307570|SUPERIORITY||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.25||0.3776|TWO_SIDED|95.0|-0.7194|0.2759|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.2759|-0.7194|0.3776
71796694|NCT01675882|143092163|SUPERIORITY||Difference in LS mean|1.3|||<|0.0001|TWO_SIDED|95.0|0.79|2.01||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||2.01|0.79|<0.0001
71796695|NCT01675882|143092163|SUPERIORITY||Difference in LS mean|2.1|||<|0.0001|TWO_SIDED|95.0|1.39|3.11||P-value was based on type III sum of squares from an ANCOVA model on log transformed values for the immunological marker at Month 12, including treatment group, Baseline marker, age-strata and country as covariates.|ANCOVA|||The LS mean for any given treatment group was the estimated mean for a participant in that treatment group with the mean value for all baseline covariates in the analysis set.||3.11|1.39|<0.0001
71796696|NCT00735371|143092167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
71796697|NCT00735371|143092167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71796698|NCT00735371|143092167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71796699|NCT00735371|143092168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0235||95.0|||||Cochran-Mantel-Haenszel|||||||0.0235
71796700|NCT00735371|143092168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71796701|NCT00735371|143092168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71796702|NCT00994448|143092170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.3|STANDARD_ERROR_OF_MEAN|8.6||0.08|TWO_SIDED|95.0|1.8|34.3|||t-test, 2 sided|||t test for mean of days retained in the bupropion versus placebo groups||34.3|1.8|0.08
71796703|NCT00436748|143092172|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Exact|||The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||<0.001
71796704|NCT00436748|143092172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293|||||||Exact|||The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p \> 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.||||0.293
71796705|NCT01610791|143092188|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in ALT from Baseline to Week 24||||<0.001
71796706|NCT01610791|143092188|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in AST from Baseline to Week 24||||<0.001
71796707|NCT01610791|143092189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Diffrence in total cholesterol from baseline to Week 24||||<0.001
71796708|NCT01610791|143092189|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Difference in LDL cholesterol from baseline to Week 24||||<0.001
71796709|NCT00357370|143092220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1898|||TWO_SIDED|95.0|-1.08|-0.32|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.32|-1.08|
71796710|NCT00357370|143092220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.1903|||TWO_SIDED|95.0|-1.16|-0.4|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-0.40|-1.16|
71796711|NCT00357370|143092221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.44|STANDARD_ERROR_OF_MEAN|11.4753|||TWO_SIDED|95.0|-38.37|7.48|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||7.48|-38.37|
71796712|NCT00357370|143092221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.44|STANDARD_ERROR_OF_MEAN|11.4574|||TWO_SIDED|95.0|-50.33|-4.55|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||-4.55|-50.33|
71796713|NCT00357370|143092225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|3.8302|||TWO_SIDED|95.0|-10.69|4.6|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||4.60|-10.69|
71796714|NCT00357370|143092225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|3.8291|||TWO_SIDED|95.0|-10.17|5.12|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.|||5.12|-10.17|
71796715|NCT00404352|143092234|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
71796716|NCT00404352|143092234|SUPERIORITY_OR_OTHER|||||||0.008|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.008
71796717|NCT00404352|143092234|SUPERIORITY_OR_OTHER|||||||0.009|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.009
71796718|NCT00404352|143092235|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||<0.001
71796719|NCT00404352|143092235|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.002
71796720|NCT00404352|143092235|SUPERIORITY_OR_OTHER|||||||0.774|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.||||||0.774
71796721|NCT04630093|143092262|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline vs. 6 months after receiving panel-based pharmacogenetic testing||||0.001
71796722|NCT00544076|143092314|EQUIVALENCE|The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,|||||>|0.1||||||no adjustments were made.|Fisher Exact|||||||>0.1
71796723|NCT00544076|143092315|OTHER||||||>|0.1||||||no adjustments done|Chi-squared|no adjustments||compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)||||>0.1
71796724|NCT00544076|143092316|OTHER||||||>|0.2||||||no adjustments done.|ANOVA|||||||>0.2
71796725|NCT00544076|143092317|OTHER||Mean Difference (Final Values)|0.08||||0.08|TWO_SIDED|||||no adjustments|ANOVA|no adjustments for df||"ANOVA test to compare difference of penile length (from baseline to month 18) across arms.~calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken."||||0.08
71796726|NCT01495585|143092387|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||0.03
71673772|NCT01197534|142866016|SUPERIORITY_OR_OTHER||Treatment difference|2.47|||<|0.001|TWO_SIDED|95.0|1.47|3.48||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.48|1.47|<0.001
71796727|NCT01495585|143092387|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.||||<0.0001
71796728|NCT01495585|143092388|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71796729|NCT01495585|143092388|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71796730|NCT05627518|143092418|OTHER||Ratio|1.9954|||<|0.0001|TWO_SIDED|95.0|1.8399|2.1641|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|The Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.1641|1.8399|<0.0001
71796731|NCT05627518|143092418|OTHER||Ratio|2.125|||<|0.0001|TWO_SIDED|95.0|1.9664|2.2963|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|AUClast: Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.2963|1.9664|<0.0001
71796732|NCT05627518|143092419|OTHER|Ratio|Ratio|2.3167|||<|0.0001|TWO_SIDED|95.0|2.0922|2.5652|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treatment A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||2.5652|2.0922|<0.0001
71796733|NCT05627518|143092420|OTHER|Ratio|Ratio|0.757|||<|0.0001|TWO_SIDED|95.0|0.7009|0.8177|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8177|0.7009|<0.0001
71796734|NCT05627518|143092420|OTHER|Ratio|Ratio|0.7684|||<|0.0001|TWO_SIDED|95.0|0.7102|0.8313|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.8313|0.7102|<0.0001
71796735|NCT05627518|143092421|OTHER|Ratio|Ratio|0.2548|||<|0.0001|TWO_SIDED|95.0|0.1999|0.3247|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3247|0.1999|<0.0001
71796736|NCT05627518|143092422|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUCinf comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
71796737|NCT05627518|143092422|OTHER|Ratio|Ratio|3.5277|||<|0.0001|TWO_SIDED|95.0|2.9076|4.2799|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean AUClast comparing test formulation fasted (treatment B) vs. reference formulation fasted (treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||4.2799|2.9076|<0.0001
71796738|NCT05627518|143092423|OTHER|Ratio|Ratio|3.0245|||<|0.0001|TWO_SIDED|95.0|2.5098|3.6446|||Mixed Models Analysis||Treatment B (1x100 mg test formulation) divided by treament A (4x25 mg reference formulation)|Ratio of geometric mean Cmax comparing test formulation fasted (treatment B) vs. reference formulation fasted ( treatment A). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||3.6446|2.5098|<0.0001
71796739|NCT05627518|143092424|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4131|0.5867|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUCinf comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5867|0.4131|<0.0001
71796740|NCT05627518|143092424|OTHER|Ratio|Ratio|0.4923|||<|0.0001|TWO_SIDED|95.0|0.4047|0.5989|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean AUClast comparing treatment C (fed) versus treatment B (fasted). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.5989|0.4047|<0.0001
71796741|NCT05627518|143092425|OTHER|Ratio|Ratio|0.2522|||<|0.0001|TWO_SIDED|95.0|0.198|0.3211|||Mixed Models Analysis||Treatment C (1x100 mg test formulation fed) divided by treament B (100 mg test formulation fasted)|Ratio of geometric mean Cmax comparing test formulation fed (treatment C) vs. reference formulation fasted (treatment B). This is a relative comparison, thus there is no unit. The ratio is given under the Estimated value.||0.3211|0.1980|<0.0001
71796742|NCT01336738|143092440|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.164||0.6803|TWO_SIDED|80.0|-0.13|0.29||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.29|-0.13|0.6803
71893269|NCT04321343|143307570|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.232||0.0424|TWO_SIDED|95.0|-0.9426|0.017|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.0170|-0.9426|0.0424
71893270|NCT04321343|143307571|SUPERIORITY||Odds Ratio (OR)|3.31||||0.1084|TWO_SIDED|95.0|0.775|14.152|||Cochran-Mantel-Haenszel|||||14.152|0.775|0.1084
71893271|NCT04321343|143307571|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
71840317|NCT05194956|143189896|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-23.2|||<|5e-05|TWO_SIDED|95.0|-30.71|-15.75||From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|Two-period two-treatment crossover ANOVA||This estimation value assumes period and sequence effects are equal between the treatments.|||-15.75|-30.71|<0.00005
71840318|NCT05194956|143189896|SUPERIORITY|Sequence effects||||||0.1369|||||||ANOVA|||||||0.1369
71840319|NCT05194956|143189896|SUPERIORITY|Period effects||||||0.3366|||||||ANOVA|||||||0.3366
71893272|NCT04321343|143307571|SUPERIORITY||Odds Ratio (OR)|1.87||||0.3333|TWO_SIDED|95.0|0.501|6.948|||Cochran-Mantel-Haenszel|||||6.948|0.501|0.3333
71893273|NCT04321343|143307572|SUPERIORITY||Odds Ratio (OR)|1.21||||0.7677|TWO_SIDED|95.0|0.345|4.23|||Cochran-Mantel-Haenszel|||||4.230|0.345|0.7677
71796743|NCT01336738|143092440|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.166||0.0017|TWO_SIDED|80.0|-0.71|-0.28||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.28|-0.71|0.0017
71796744|NCT01336738|143092440|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.168||0.0003|TWO_SIDED|80.0|-0.8|-0.36||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.36|-0.80|0.0003
71796745|NCT01336738|143092440|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.162|<|0.0001|TWO_SIDED|80.0|-0.91|-0.5||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.50|-0.91|<0.0001
71796746|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|5.292||0.4757|TWO_SIDED|95.0|-6.64|14.2||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.20|-6.64|0.4757
71796747|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|5.296||0.8031|TWO_SIDED|95.0|-9.11|11.75||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.75|-9.11|0.8031
71796748|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.22|STANDARD_ERROR_OF_MEAN|5.364||0.549|TWO_SIDED|95.0|-13.78|7.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.34|-13.78|0.5490
71796749|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.34||0.0051|TWO_SIDED|95.0|-25.58|-4.55||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.55|-25.58|0.0051
71893274|NCT04321343|143307572|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
71796750|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|5.02||0.6291|TWO_SIDED|95.0|-12.31|7.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||7.46|-12.31|0.6291
71840320|NCT05194956|143189897|SUPERIORITY|All units of measure reported for this analysis are the mean within-patient differences between alginate and scan VAS scores (i.e. alginate score - scan score)|Mean Difference (Net)|-120.0|||<|5e-05|TWO_SIDED|95.0|-149.54|-90.38|||Two-period two-treatment crossover ANOVA|From a 2-period 2-treatment crossover ANOVA, taking sequence and period effects into account|This estimation value assumes period and sequence effects are equal between the treatments.|||-90.38|-149.54|<0.00005
71840321|NCT05194956|143189897|SUPERIORITY|Sequence effects||||||0.8509|||||||ANOVA|||||||0.8509
71840322|NCT05194956|143189897|SUPERIORITY|Period effects||||||0.0355|||||||ANOVA|||||||0.0355
71840323|NCT03687086|143189899|SUPERIORITY||Odds Ratio (OR)|1.95|STANDARD_ERROR_OF_MEAN|0.63||0.039|TWO_SIDED|95.0|1.03|3.7|||Regression, Logistic|||||3.70|1.03|.039
71840324|NCT03687086|143189900|SUPERIORITY||Mean Difference (Net)|1.38|STANDARD_ERROR_OF_MEAN|0.97||0.155|TWO_SIDED|95.0|-0.52|3.29|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 Weeks vs. baseline)||||3.29|-0.52|0.155
71840325|NCT03687086|143189901|SUPERIORITY||Median Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.04||0.88|TWO_SIDED|95.0|-1.88|2.2|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||2.20|-1.88|0.880
71840326|NCT03687086|143189902|SUPERIORITY||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.228|TWO_SIDED|95.0|-1.25|0.3|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.30|-1.25|0.228
71893275|NCT04321343|143307572|SUPERIORITY||Odds Ratio (OR)|1.97||||0.2711|TWO_SIDED|95.0|0.598|6.486|||Cochran-Mantel-Haenszel|||||6.486|0.598|0.2711
71893276|NCT04321343|143307573|SUPERIORITY||Odds Ratio (OR)|1.44||||0.5981|TWO_SIDED|95.0|0.376|5.547|||Cochran-Mantel-Haenszel|||||5.547|0.376|0.5981
71893277|NCT04321343|143307573|SUPERIORITY||Odds Ratio (OR)|1.42||||0.6228|TWO_SIDED|95.0|0.363|5.572|||Cochran-Mantel-Haenszel|||||5.572|0.363|0.6228
71893278|NCT04321343|143307573|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8799|TWO_SIDED|95.0|0.245|3.323|||Cochran-Mantel-Haenszel|||||3.323|0.245|0.8799
71893279|NCT04321343|143307574|SUPERIORITY||Odds Ratio (OR)|3.28||||0.1474|TWO_SIDED|95.0|0.625|17.208|||Cochran-Mantel-Haenszel|||||17.208|0.625|0.1474
71796751|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|3.87|STANDARD_ERROR_OF_MEAN|5.001||0.4396|TWO_SIDED|95.0|-5.98|13.72||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.72|-5.98|0.4396
71796752|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.56|STANDARD_ERROR_OF_MEAN|5.03||0.1934|TWO_SIDED|95.0|-16.46|3.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.34|-16.46|0.1934
71796753|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.32|STANDARD_ERROR_OF_MEAN|5.039||0.0007|TWO_SIDED|95.0|-27.24|-7.4||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-7.40|-27.24|0.0007
71796754|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|5.201||0.5479|TWO_SIDED|95.0|-7.11|13.37||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.37|-7.11|0.5479
71840327|NCT03687086|143189903|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.44||0.843|TWO_SIDED|95.0|-0.96|0.78|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.78|-0.96|0.843
71840328|NCT03687086|143189904|SUPERIORITY||Odds Ratio (OR)|3.68|STANDARD_ERROR_OF_MEAN|1.48||0.001|TWO_SIDED|95.0|1.67|8.12|||Regression, Logistic|||||8.12|1.67|0.001
71840329|NCT03687086|143189905|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.42||0.443|TWO_SIDED|95.0|-1.14|0.5|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (9 weeks vs. baseline)||||0.50|-1.14|0.443
71840330|NCT03687086|143189906|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.51||0.409|TWO_SIDED|95.0|-1.41|0.58|||Mixed Models Analysis|Interaction contrast of Treatment Group (Program A vs. Program B) by Time (6 months vs. baseline)||||0.58|-1.41|0.409
71840331|NCT04201262|143189915|OTHER||Hazard Ratio (HR)|0.014|||<|0.0001|TWO_SIDED|95.0|0.0|0.103|||Log Rank||HR based on a Cox proportional hazards model, with Firth's adjustment. Confidence interval (CI)= Wald CI or Profile Likelihood CI Limits. HR for ravulizumab compared with placebo presented a 98.6% reduction in risk of relapse, 95% CI (89.7%, 100.0%).|||0.103|0.000|< 0.0001
71840332|NCT04201262|143189917|OTHER|||||||0.0122||||||Proportional Odds p-value|Univariate models|||The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.||||0.0122
71840333|NCT05446168|143189925|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis|Mean Difference (Net)|-0.08|STANDARD_DEVIATION|0.05||0.005|TWO_SIDED|95.0|-0.12|-0.03||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = -4.05, df = 7||||-0.03|-0.12|0.005
71840334|NCT05446168|143189926|OTHER|A comparison is not being made between two different treatment groups. Exploratory analysis.|Mean Difference (Net)|4.33|STANDARD_DEVIATION|12.81||0.27|TWO_SIDED|95.0|-3.81|12.47||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|t = 1.17, df = 11||||12.47|-3.81|0.27
71840335|NCT03511664|143189934|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.001|TWO_SIDED|99.2|0.29|0.57|||Log Rank|one-sided stratified log-rank test||||0.57|0.29|< 0.001
71840336|NCT03511664|143189935|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|one-sided stratified log-rank test||Primary OS Analysis||0.74|0.52|<0.001
71840337|NCT03511664|143189935|SUPERIORITY||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.58|0.81|||||Cox PH model stratified by LDH (≤260 vs. \>260 IU/L), liver metastases (yes/no), ECOG score (0-1 vs. 2), and NAAD inclusion in best supportive care at randomization (yes/no). IRT data used for stratification|Final OS analysis||0.81|0.58|
71840338|NCT03511664|143189937|SUPERIORITY||Odds Ratio (OR)|24.99|||<|0.001|TWO_SIDED|95.0|6.05|103.24|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||103.24|6.05|< 0.001
71840339|NCT03511664|143189938|SUPERIORITY||Odds Ratio (OR)|5.79|||<|0.001|TWO_SIDED|95.0|3.18|10.55|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||10.55|3.18|< 0.001
71840340|NCT03511664|143189940|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.62|||Log Rank|Two-sided stratified log-rank test||||0.62|0.40|< 0.001
71840341|NCT03511664|143189941|SUPERIORITY||Cox Proportional Hazard|0.3|||<|0.001|TWO_SIDED|95.0|0.24|0.38|||Log Rank|Two-sided stratified log-rank test||||0.38|0.24|< 0.001
71840342|NCT03511664|143189943|SUPERIORITY||Odds Ratio (OR)|11.19|||<|0.001|TWO_SIDED|95.0|6.3|20.0|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||20.0|6.3|< 0.001
71673773|NCT01197534|142866016|SUPERIORITY_OR_OTHER||Treatment difference|1.64||||0.001|TWO_SIDED|95.0|0.63|2.65||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.65|0.63|0.001
71796755|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.14|STANDARD_ERROR_OF_MEAN|5.209||0.4276|TWO_SIDED|95.0|-14.39|6.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||6.12|-14.39|0.4276
71796756|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.38|STANDARD_ERROR_OF_MEAN|5.235||0.1596|TWO_SIDED|95.0|-17.69|2.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.92|-17.69|0.1596
71796757|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.83|STANDARD_ERROR_OF_MEAN|5.198|<|0.0001|TWO_SIDED|95.0|-33.06|-12.6||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-12.60|-33.06|<0.0001
71796758|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|5.855||0.8509|TWO_SIDED|95.0|-12.63|10.43||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.43|-12.63|0.8509
71796759|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.53|STANDARD_ERROR_OF_MEAN|5.913||0.1505|TWO_SIDED|95.0|-20.17|3.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||3.12|-20.17|0.1505
71796760|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.62|STANDARD_ERROR_OF_MEAN|5.94||0.2662|TWO_SIDED|95.0|-18.31|5.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.08|-18.31|0.2662
71796761|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.52|STANDARD_ERROR_OF_MEAN|5.818||0.0003|TWO_SIDED|95.0|-32.97|-10.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-10.07|-32.97|0.0003
71796762|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|6.94||0.7724|TWO_SIDED|95.0|-15.68|11.66||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.66|-15.68|0.7724
71796763|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|6.986||0.9202|TWO_SIDED|95.0|-14.47|13.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||13.07|-14.47|0.9202
71796764|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|6.998||0.8183|TWO_SIDED|95.0|-15.4|12.18||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||12.18|-15.40|0.8183
71796765|NCT01336738|143092441|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.96|STANDARD_ERROR_OF_MEAN|6.821||0.0003|TWO_SIDED|95.0|-38.4|-11.53||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-11.53|-38.40|0.0003
71796766|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.048||0.2327|TWO_SIDED|80.0|-0.1|0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.03|-0.10|0.2327
71796767|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.048||0.358|TWO_SIDED|80.0|-0.08|0.04||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.04|-0.08|0.3580
71796768|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.0036|TWO_SIDED|80.0|-0.2|-0.07||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.07|-0.20|0.0036
71840343|NCT03511664|143189944|SUPERIORITY||Odds Ratio (OR)|23.6|||<|0.001|TWO_SIDED|95.0|8.6|65.1|||Chi-squared|Two-sided Wald's Chi-square test (stratified)||||65.1|8.6|< 0.001
71893280|NCT04321343|143307574|SUPERIORITY||Odds Ratio (OR)|2.65||||0.262|TWO_SIDED|95.0|0.481|14.631|||Cochran-Mantel-Haenszel|||||14.631|0.481|0.2620
71796769|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.1251|TWO_SIDED|80.0|-0.12|0.01||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.01|-0.12|0.1251
71796770|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.066||0.3466|TWO_SIDED|80.0|-0.11|0.06||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.06|-0.11|0.3466
71796771|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.0439|TWO_SIDED|80.0|-0.2|-0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.03|-0.20|0.0439
71796772|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.067||0.004|TWO_SIDED|80.0|-0.27|-0.09||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.09|-0.27|0.0040
71796773|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.065||0.0009|TWO_SIDED|80.0|-0.29|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.29|0.0009
71796774|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.1405|TWO_SIDED|80.0|-0.23|0.02||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.02|-0.23|0.1405
71796775|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.097||0.0067|TWO_SIDED|80.0|-0.36|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.12|-0.36|0.0067
71796776|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.098||0.0001|TWO_SIDED|80.0|-0.5|-0.24||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.24|-0.50|0.0001
71796777|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.094||0.0002|TWO_SIDED|80.0|-0.46|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.46|0.0002
71796778|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.135||0.4887|TWO_SIDED|80.0|-0.18|0.17||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||0.17|-0.18|0.4887
71796779|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.137||0.002|TWO_SIDED|80.0|-0.57|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.22|-0.57|0.0020
71796780|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|80.0|-0.76|-0.41||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.41|-0.76|<0.0001
71796781|NCT01336738|143092442|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|80.0|-0.76|-0.42||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.||-0.42|-0.76|<0.0001
71893281|NCT04321343|143307574|SUPERIORITY||Odds Ratio (OR)|0.7||||0.6935|TWO_SIDED|95.0|0.117|4.133|||Cochran-Mantel-Haenszel|||||4.133|0.117|0.6935
71893282|NCT04321343|143307575|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6384|TWO_SIDED|95.0|-0.35|0.215|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.215|-0.350|0.6384
71893283|NCT04321343|143307575|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.0549|TWO_SIDED|95.0|-0.547|0.006|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.006|-0.547|0.0549
71893284|NCT04321343|143307575|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.683|-0.142|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.142|-0.683|0.0030
71796782|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.225||0.2067|TWO_SIDED|95.0|-0.16|0.73||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.73|-0.16|0.2067
71796783|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.224||0.8602|TWO_SIDED|95.0|-0.4|0.48||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.48|-0.40|0.8602
71796784|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.225||0.92|TWO_SIDED|95.0|-0.47|0.42||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.42|-0.47|0.9200
71796785|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.223||0.0399|TWO_SIDED|95.0|0.02|0.9||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.90|0.02|0.0399
71796786|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.242||0.2266|TWO_SIDED|95.0|-0.18|0.77||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.77|-0.18|0.2266
71796787|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.241||0.8493|TWO_SIDED|95.0|-0.43|0.52||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.43|0.8493
71673774|NCT01197534|142866017|SUPERIORITY_OR_OTHER||Treatment difference|2.09|||<|0.001|TWO_SIDED|95.0|0.97|3.2||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.20|0.97|<0.001
71796788|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.242||0.9511|TWO_SIDED|95.0|-0.49|0.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.46|-0.49|0.9511
71796789|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.241||0.1369|TWO_SIDED|95.0|-0.11|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.11|0.1369
71796790|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.272||0.1562|TWO_SIDED|95.0|-0.15|0.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.15|0.1562
71796791|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.272||0.4913|TWO_SIDED|95.0|-0.72|0.35||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.35|-0.72|0.4913
71796792|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.272||0.513|TWO_SIDED|95.0|-0.36|0.71||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.71|-0.36|0.5130
71796793|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.269||0.0298|TWO_SIDED|95.0|0.06|1.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.12|0.06|0.0298
71796794|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.363||0.3196|TWO_SIDED|95.0|-0.35|1.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.08|-0.35|0.3196
71796795|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.367||0.8884|TWO_SIDED|95.0|-0.77|0.67||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.67|-0.77|0.8884
71796796|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.365||0.7325|TWO_SIDED|95.0|-0.59|0.84||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.84|-0.59|0.7325
71673775|NCT01197534|142866017|SUPERIORITY_OR_OTHER||Treatment difference|1.96|||<|0.001|TWO_SIDED|95.0|0.83|3.08||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.08|0.83|<0.001
71673776|NCT02589639|142866068|SUPERIORITY|The superiority of empagliflozin 10 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.11|-0.73|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment||"The statistical model was:~Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error"|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|-0.73|-1.11|<0.0001
71673777|NCT02589639|142866068|SUPERIORITY|The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.18|-0.82|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error||-0.82|-1.18|<0.0001
71673778|NCT01014169|142866075|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.95|1.34||||||||1.34|0.95|
71673779|NCT01014169|142866076|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.99|1.25||||||||1.25|0.99|
71673780|NCT01014169|142866077|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||||95.0|1.0|1.25||||||||1.25|1.00|
71673781|NCT02593097|142866086|SUPERIORITY|||||||0.83|||||||Hills-Armitage|||||||0.83
71796797|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.357||0.3395|TWO_SIDED|95.0|-0.36|1.04||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.04|-0.36|0.3395
71673782|NCT02593097|142866087|SUPERIORITY|||||||0.16|||||||McNemar|||||||0.16
71673783|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||A priori threshold p \< 0.05|Repeated Measures ANOVA|||||||<0.00005
71796798|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.41||0.7514|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7514
71673784|NCT02811965|142866134|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
71796799|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.413||0.7529|TWO_SIDED|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.68|0.7529
71796800|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.411||0.9638|TWO_SIDED|95.0|-0.79|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.83|-0.79|0.9638
71796801|NCT01336738|143092444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.404||0.0962|TWO_SIDED|95.0|-0.12|1.47||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.47|-0.12|0.0962
71796802|NCT02970968|143092448|SUPERIORITY|||||||0.0099|||||||Mixed Models Analysis|||||||.0099
71673785|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71796803|NCT02970968|143092449|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||||||.0160
71673786|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673787|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673788|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673789|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673790|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673791|NCT02811965|142866134|SUPERIORITY|||||||0.01||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.01
71673792|NCT02811965|142866134|SUPERIORITY|||||||0.0002||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0002
71673793|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673794|NCT02811965|142866134|SUPERIORITY||||||<|5e-05|||||||t-test, 2 sided|||||||<0.00005
71796804|NCT02970968|143092450|SUPERIORITY|||||||0.039|||||||Mixed Models Analysis|||||||.039
71673795|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673796|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673797|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673798|NCT02811965|142866134|SUPERIORITY|||||||0.24||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.24
71673799|NCT02811965|142866134|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
71673800|NCT02811965|142866134|SUPERIORITY|||||||0.0093||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0093
71673801|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673802|NCT02811965|142866134|SUPERIORITY|||||||0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.14
71796805|NCT02970968|143092451|SUPERIORITY|||||||0.0223|||||||Mixed Models Analysis|||||||.0223
71796806|NCT02970968|143092452|SUPERIORITY|||||||0.0497|||||||Mixed Models Analysis|||||||.0497
71796807|NCT02970968|143092453|SUPERIORITY|||||||0.0207|||||||Mixed Models Analysis|||||||.0207
71796808|NCT02970968|143092454|SUPERIORITY|||||||0.0429|||||||Mixed Models Analysis|||||||.0429
71893285|NCT04321343|143307576|SUPERIORITY||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.389||0.8961|TWO_SIDED|95.0|-0.8165|0.7149|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7149|-0.8165|0.8961
71796809|NCT02970968|143092455|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71796810|NCT02970968|143092456|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||.0003
71796811|NCT02970968|143092457|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
71796812|NCT02970968|143092458|SUPERIORITY|||||||0.0078|||||||Mixed Models Analysis|||||||.0078
71796813|NCT02970968|143092459|SUPERIORITY|||||||0.0294|||||||Mixed Models Analysis|||||||.0294
71796814|NCT02970968|143092460|SUPERIORITY|||||||0.0229|||||||Mixed Models Analysis|||||||.0229
71673803|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673804|NCT02811965|142866134|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673805|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||A priori threshold p\<0.05.|Repeated Measures ANOVA|||||||<0.00005
71673806|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673807|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673808|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673809|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673810|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673811|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673812|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673813|NCT02811965|142866135|SUPERIORITY|||||||0.0011||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.0011
71673814|NCT02811965|142866135|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
71673815|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673816|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673817|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673818|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71796815|NCT02970968|143092461|SUPERIORITY|||||||0.0018|||||||Mixed Models Analysis|||||||.0018
71796816|NCT02970968|143092462|SUPERIORITY|||||||0.0013|||||||Mixed Models Analysis|||||||.0013
71796817|NCT02970968|143092463|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||.0001
71796818|NCT02970968|143092464|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||.018
71796819|NCT02970968|143092465|SUPERIORITY|||||||0.0164|||||||Mixed Models Analysis|||||||.0164
71796820|NCT02970968|143092466|SUPERIORITY|||||||0.0053|||||||Mixed Models Analysis|||||||.0053
71796821|NCT02970968|143092467|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.0020
71796822|NCT03003520|143092470|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
71796823|NCT03003520|143092470|SUPERIORITY||AUC-ROC|0.477||||0.872|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their CD8 density.||||0.872
71796824|NCT03003520|143092471|SUPERIORITY|||||||0.0403||||||Significance defined as 0.05.|Fisher Exact|||||||0.0403
71893286|NCT04321343|143307576|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.384||0.671|TWO_SIDED|95.0|-0.5935|0.9204|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.9204|-0.5935|0.6710
71893287|NCT04321343|143307576|SUPERIORITY||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.364||0.9846|TWO_SIDED|95.0|-0.7092|0.7233|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.7233|-0.7092|0.9846
71796825|NCT03003520|143092471|SUPERIORITY||AUC-ROC|0.583||||0.523|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of total cells.||||0.523
71796826|NCT03003520|143092472|SUPERIORITY||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact|||||||>0.99
71796827|NCT03003520|143092472|SUPERIORITY||AUC-ROC|0.583||||0.557|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of tumor cells.||||0.557
71796828|NCT03003520|143092473|SUPERIORITY|||||||0.662||||||Significance defined as 0.05.|Fisher Exact|||||||0.662
71796829|NCT03003520|143092473|SUPERIORITY||AUC-ROC|0.6||||0.399|TWO_SIDED|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their IFNG-Score.||||0.399
71796830|NCT01332149|143092476|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.148||0.0559|TWO_SIDED|95.0|-0.58|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.01|-0.58|0.0559
71796831|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0527|TWO_SIDED|95.0|-0.47|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.47|0.0527
71796832|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.121||0.0279|TWO_SIDED|95.0|-0.5|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.50|0.0279
71796833|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.121||0.0508|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.48|0.0508
71796834|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.121||0.0349|TWO_SIDED|95.0|-0.49|-0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.02|-0.49|0.0349
71796835|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.122||0.0672|TWO_SIDED|95.0|-0.46|0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.46|0.0672
71796836|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.122||0.0469|TWO_SIDED|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.00|-0.48|0.0469
71796837|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.028|TWO_SIDED|95.0|-0.51|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.03|-0.51|0.0280
71796838|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.122||0.014|TWO_SIDED|95.0|-0.54|-0.06||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.06|-0.54|0.0140
71893288|NCT04321343|143307577|SUPERIORITY||Mean Difference (Final Values)|-84.93|STANDARD_ERROR_OF_MEAN|36.75||0.0216|TWO_SIDED|95.0|-157.306|-12.558|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-12.558|-157.306|0.0216
71893289|NCT04321343|143307577|SUPERIORITY||Mean Difference (Final Values)|-46.61|STANDARD_ERROR_OF_MEAN|35.72||0.1931|TWO_SIDED|95.0|-116.957|23.738|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||23.738|-116.957|0.1931
71796839|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.122||0.0375|TWO_SIDED|95.0|-0.49|-0.01||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.01|-0.49|0.0375
71796840|NCT01332149|143092477|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.105||0.0164|TWO_SIDED|95.0|-0.46|-0.05||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis||Overall change was estimated from the mixed effect model treatment main effect.|Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.46|0.0164
71796841|NCT01332149|143092479|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.143||0.134|TWO_SIDED|95.0|-0.49|0.07||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.07|-0.49|0.1340
71796842|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.3438|TWO_SIDED|95.0|-0.37|0.13||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.13|-0.37|0.3438
71796843|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.128||0.2482|TWO_SIDED|95.0|-0.4|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.40|0.2482
71796844|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2249|TWO_SIDED|95.0|-0.41|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.10|-0.41|0.2249
71796845|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1094|TWO_SIDED|95.0|-0.46|0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.05|-0.46|0.1094
71796846|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.129||0.2095|TWO_SIDED|95.0|-0.41|0.09||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.09|-0.41|0.2095
71796847|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.129||0.0531|TWO_SIDED|95.0|-0.5|0.0||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.00|-0.50|0.0531
71796848|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1628|TWO_SIDED|95.0|-0.44|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.44|0.1628
71796849|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|95.0|-0.48|0.02||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.02|-0.48|0.0770
71796850|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.1651|TWO_SIDED|95.0|-0.43|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.07|-0.43|0.1651
71796851|NCT01332149|143092480|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.1006|TWO_SIDED|95.0|-0.4|0.04||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||0.04|-0.40|0.1006
71893290|NCT04321343|143307577|SUPERIORITY||Mean Difference (Final Values)|-63.4|STANDARD_ERROR_OF_MEAN|33.31||0.0581|TWO_SIDED|95.0|-129.002|2.194|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.194|-129.002|0.0581
71796852|NCT01332149|143092481|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.1309|TWO_SIDED|95.0|0.93|1.74||Analysis was two-sided and performed at the 0.05 significance level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||1.74|0.93|0.1309
71893291|NCT04321343|143307578|SUPERIORITY||Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.153||0.0958|TWO_SIDED|95.0|-0.5577|0.0456|||Mixed Models Analysis|Mixed Models Analysis|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0456|-0.5577|0.0958
71893292|NCT04321343|143307578|SUPERIORITY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.148||0.0659|TWO_SIDED|95.0|-0.5648|0.0181|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0181|-0.5648|0.0659
71893293|NCT04321343|143307578|SUPERIORITY||Mean Difference (Final Values)|-0.301|STANDARD_ERROR_OF_MEAN|0.138||0.0297|TWO_SIDED|95.0|-0.5728|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0300|-0.5728|0.0297
71893294|NCT04321343|143307579|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.175||0.2606|TWO_SIDED|95.0|-0.5423|0.1476|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1476|-0.5423|0.2606
71893295|NCT04321343|143307579|SUPERIORITY||Mean Difference (Final Values)|-0.234|STANDARD_ERROR_OF_MEAN|0.17||0.1709|TWO_SIDED|95.0|-0.569|0.1016|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.1016|-0.5690|0.1709
71893296|NCT04321343|143307579|SUPERIORITY||Mean Difference (Final Values)|-0.321|STANDARD_ERROR_OF_MEAN|0.155||0.04|TWO_SIDED|95.0|-0.6274|-0.0148|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-0.0148|-0.6274|0.0400
71893297|NCT04321343|143307580|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3955|TWO_SIDED|95.0|-0.0139|0.0351|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0351|-0.0139|0.3955
71893298|NCT04321343|143307580|SUPERIORITY||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3081|TWO_SIDED|95.0|-0.0115|0.0362|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0362|-0.0115|0.3081
71673819|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71796853|NCT01332149|143092484|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.25|STANDARD_ERROR_OF_MEAN|1.628||0.0463|TWO_SIDED|95.0|-6.45|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||-0.05|-6.45|0.0463
71796854|NCT01332149|143092485|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.061||0.2748|TWO_SIDED|95.0|-0.19|0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.05|-0.19|0.2748
71796855|NCT01332149|143092487|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|1.577||0.4758|TWO_SIDED|95.0|-4.22|1.97||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.97|-4.22|0.4758
71796856|NCT01332149|143092488|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.31|STANDARD_ERROR_OF_MEAN|2.22||0.1363|TWO_SIDED|95.0|-1.05|7.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||7.67|-1.05|0.1363
71796857|NCT01332149|143092489|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.371||0.8808|TWO_SIDED|95.0|-2.49|2.9||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.90|-2.49|0.8808
71796858|NCT01332149|143092490|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.0887|TWO_SIDED|95.0|-0.03|0.4||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.40|-0.03|0.0887
71893299|NCT04321343|143307580|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.011||0.1374|TWO_SIDED|95.0|-0.0053|0.0383|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||0.0383|-0.0053|0.1374
71893300|NCT04321343|143307581|SUPERIORITY||Mean Difference (Final Values)|-48.94|STANDARD_ERROR_OF_MEAN|20.86||0.0199|TWO_SIDED|95.0|-90.073|-7.817|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-7.817|-90.073|0.0199
71893301|NCT04321343|143307581|SUPERIORITY||Mean Difference (Final Values)|-29.77|STANDARD_ERROR_OF_MEAN|18.66||0.112|TWO_SIDED|95.0|-66.558|7.009|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||7.009|-66.558|0.1120
71893302|NCT04321343|143307581|SUPERIORITY||Mean Difference (Final Values)|-54.64|STANDARD_ERROR_OF_MEAN|17.9||0.0026|TWO_SIDED|95.0|-89.935|-19.34|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||-19.340|-89.935|0.0026
71893303|NCT04321343|143307582|SUPERIORITY||Mean Difference (Final Values)|1.674|STANDARD_ERROR_OF_MEAN|0.896||0.0639|TWO_SIDED|95.0|-0.098|3.447|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.4470|-0.0980|0.0639
71893304|NCT04321343|143307582|SUPERIORITY||Mean Difference (Final Values)|2.831|STANDARD_ERROR_OF_MEAN|0.867||0.0014|TWO_SIDED|95.0|1.1149|4.5464|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.5464|1.1149|0.0014
71893305|NCT04321343|143307582|SUPERIORITY||Mean Difference (Final Values)|4.876|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|3.1982|6.5543|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||6.5543|3.1982|<0.0001
71893306|NCT04321343|143307583|SUPERIORITY||Mean Difference (Final Values)|1.183|STANDARD_ERROR_OF_MEAN|0.909||0.1944|TWO_SIDED|95.0|-0.608|2.9748|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.9748|-0.6080|0.1944
71673820|NCT02811965|142866135|SUPERIORITY|||||||0.53||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.53
71796859|NCT01332149|143092491|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.7929|TWO_SIDED|95.0|0.72|1.53||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||1.53|0.72|0.7929
71796860|NCT01332149|143092492|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.973||0.596|TWO_SIDED|95.0|-2.83|4.92||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||4.92|-2.83|0.5960
71840344|NCT03435614|143189990|OTHER||||||||||||||||||We selected the individual signs and symptoms associated with the presence of OIWS based on a difference of greater than 15 % in the assessments between the group with OIWS and the group not displaying OIWS. This 15 % difference was judged to be of clinical significance. The signs and symptoms which did not meet this difference were not considered (data not available).|||
71840345|NCT05698875|143190026|OTHER||Fixed effects parameter|1.0||||0.12|TWO_SIDED|95.0|0.1|1.9||P=0.04 however was adjusted using the Bonferroni correction The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.9|0.1|0.12
71840346|NCT05698875|143190026|OTHER||Fixed effects parameter|-0.58||||0.23|TWO_SIDED|95.0|-1.5|0.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs control meal||0.4|-1.5|0.23
71840347|NCT05698875|143190026|OTHER||Fixed effects parameter|0.24||||0.62|TWO_SIDED|95.0|-0.7|1.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL vs control meal||1.2|-0.7|0.62
71840348|NCT05698875|143190026|OTHER||Fixed effects parameter|1.6||||0.003|TWO_SIDED|95.0|0.7|2.5||Above is adjusted p value using Bonferroni correction. The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs HGLP||2.5|0.7|0.003
71840349|NCT05698875|143190026|OTHER||Fixed effects parameter|0.82||||0.08|TWO_SIDED|95.0|-0.1|1.7||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs MGL meals||1.7|-0.1|0.08
71673821|NCT02811965|142866135|SUPERIORITY|||||||0.092||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.092
71796861|NCT01332149|143092493|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|1.536||0.8216|TWO_SIDED|95.0|-3.36|2.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||2.67|-3.36|0.8216
71796862|NCT01332149|143092494|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.177||0.4829|TWO_SIDED|95.0|-3.14|1.49||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||1.49|-3.14|0.4829
71840350|NCT05698875|143190026|OTHER||Fixed effects parameter|-0.8||||0.12|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.2|-1.7|0.12
71840351|NCT05698875|143190027|OTHER||Mean Difference (Final Values)|0.835||||0.08|TWO_SIDED|95.0|-0.1|1.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL vs control meals||1.8|-0.1|0.08
71840352|NCT05698875|143190027|OTHER||Mean Difference (Final Values)|-0.7||||0.13|TWO_SIDED|95.0|-1.7|0.2||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meal vs control meal||0.2|-1.7|0.13
71840353|NCT05698875|143190027|OTHER||Mean Difference (Final Values)|-0.2||||0.68|TWO_SIDED|95.0|-1.2|0.8||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.8|-1.2|0.68
71840354|NCT05698875|143190027|OTHER||Mean Difference (Final Values)|1.6|||<|0.01|TWO_SIDED|95.0|0.7|2.5||The a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||2.5|0.7|<0.01
71840355|NCT05698875|143190027|OTHER||Mean Difference (Final Values)|1.1||||0.06|TWO_SIDED|95.0|0.2|2.0||The a priori threshold for statistical significance p\<0.05 p value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||2.0|0.2|0.06
71840356|NCT05698875|143190027|OTHER||Mean Difference (Final Values)|-0.5||||0.29|TWO_SIDED|95.0|-1.4|0.4||a priori threshold for statistical significance - P\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.4|-1.4|0.29
71840357|NCT05698875|143190028|OTHER||Mean Difference (Final Values)|1.9|||<|0.01|TWO_SIDED|95.0|0.8|3.0||The a priori threshold for statistical significance p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||3.0|0.8|<0.01
71673822|NCT02811965|142866135|SUPERIORITY|||||||0.0044|||||||t-test, 2 sided|||||||0.0044
71796863|NCT01332149|143092495|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.073||0.0431|TWO_SIDED|95.0|-0.29|0.0||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||-0.00|-0.29|0.0431
71840358|NCT05698875|143190028|OTHER||Mean Difference (Final Values)|-0.3||||0.59|TWO_SIDED|95.0|-1.4|0.8||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.8|-1.4|0.59
71840359|NCT05698875|143190028|OTHER||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.2|1.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.0|-1.2|0.86
71840360|NCT05698875|143190028|OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||3.3|1.2|<0.001
71840361|NCT05698875|143190028|OTHER||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.1||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction did not alter p value|Linear Mixed Model|||HGL vs MGL meals||3.1|1.1|<0.001
71840362|NCT05698875|143190028|OTHER||Mean Difference (Final Values)|-0.1||||0.79|TWO_SIDED|95.0|-1.2|0.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||0.9|-1.2|0.79
71840363|NCT05698875|143190029|OTHER||Mean Difference (Final Values)|-8.5||||0.31|TWO_SIDED|95.0|-25.0|8.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGL meals vs control meals||8|-25|0.31
71796864|NCT01332149|143092496|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.074||0.0602|TWO_SIDED|95.0|-0.28|0.01||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.||0.01|-0.28|0.0602
71796865|NCT01332149|143092498|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.207||0.4172|TWO_SIDED|95.0|-0.57|0.24||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.24|-0.57|0.4172
71673823|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673824|NCT02811965|142866135|SUPERIORITY|||||||0.084||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.084
71673825|NCT02811965|142866135|SUPERIORITY||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||<0.00005
71673826|NCT02811965|142866135|SUPERIORITY|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p\<0.05.|t-test, 2 sided|||||||0.00005
71673827|NCT01554527|142866142|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.07
71673828|NCT01554527|142866143|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.34
71673829|NCT01554527|142866144|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.93
71673830|NCT01554527|142866145|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.5
71673831|NCT01554527|142866146|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)||||0.25
71673832|NCT01052480|142866150|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
71796866|NCT01332149|143092499|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3724|TWO_SIDED|95.0|-0.62|0.23||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.||||0.23|-0.62|0.3724
71673833|NCT00529373|142866172|OTHER||Hazard Ratio (HR)|0.46|||<|0.001|TWO_SIDED|95.0|0.4|0.53|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.53|0.40|<0.001
71673834|NCT00529373|142866173|OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.71|0.39|<0.001
71673835|NCT00529373|142866174|OTHER||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.68|0.87|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.87|0.68|<0.001
71796867|NCT00048542|143092576|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Chi-square test|||The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.||||0.031
71796868|NCT00048542|143092578|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-square test|||||||0.015
71796869|NCT00048542|143092579|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Log Rank|||||||0.029
71796870|NCT00048542|143092580|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Log Rank|||||||0.031
71673836|NCT00529373|142866175|OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.42|0.55|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.||0.55|0.42|<0.001
71673837|NCT00529373|142866176|OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.67|0.40|<0.001
71673838|NCT00529373|142866177|OTHER||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.66|0.83|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.83|0.66|<0.001
71673839|NCT00529373|142866178|OTHER|Miettinen \& Nurminen|Difference in rates|0.88|||||TWO_SIDED|95.0|-2.3|4.07||||||||4.07|-2.3|
71673840|NCT00529373|142866179|OTHER|Miettinen \& Nurminen|Difference in rates|0.11|||||TWO_SIDED|95.0|-0.16|0.37||||||||0.37|-0.16|
71673841|NCT00529373|142866183|OTHER||Difference in Least Squares Means|8.92|||<|0.001|TWO_SIDED|95.0|3.9|13.93|||Longitudinal model|||Odanacatib 50 mg vs Placebo||13.93|3.9|<0.001
71673842|NCT00529373|142866184|OTHER||Difference in Least Squares Means|26.45|||<|0.001|TWO_SIDED|95.0|16.49|36.4|||Longitudinal model|||Odanacatib 50 mg vs Placebo||36.40|16.49|<0.001
71673843|NCT00529373|142866185|OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.14|0.09||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.14|
71673844|NCT00529373|142866185|OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.12|0.12||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.12|-0.12|
71673845|NCT00529373|142866185|OTHER||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.17|0.09||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.09|-0.17|
71796871|NCT00048542|143092581|SUPERIORITY_OR_OTHER|||||||0.061||95.0|||||Pearson's Chi-square test|||||||0.061
71796872|NCT00048542|143092581|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
71796873|NCT00048542|143092582|SUPERIORITY_OR_OTHER|||||||0.103||95.0|||||Pearson's Chi-square test|||||||0.103
71796874|NCT00048542|143092582|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Pearson's Chi-square test|||||||0.028
71796875|NCT00048542|143092583|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||Pearson's Chi-square test|||||||0.156
71796876|NCT00048542|143092583|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Pearson's Chi-square test|||||||0.002
71796877|NCT02272413|143092623|EQUIVALENCE|The null hypothesis was to be rejected in favor of equivalence if the 2-sided 90% confidence interval (CI) for the ratio in best ORR between the treatments was entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|90.0|0.7697|0.9506|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9506|0.7697|
71673846|NCT00529373|142866185|OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|95.0|-0.5|0.08||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.08|-0.50|
71673847|NCT00529373|142866186|OTHER||Difference in Least Squares Means|0.11|||||TWO_SIDED|95.0|-0.16|0.38||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.38|-0.16|
71673848|NCT00529373|142866186|OTHER||Difference in Least Squares Means|0.14|||||TWO_SIDED|95.0|-0.15|0.44||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.44|-0.15|
71673849|NCT00529373|142866186|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.15|0.54||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.54|-0.15|
71673850|NCT00529373|142866186|OTHER||Difference in Least Squares Means|0.19|||||TWO_SIDED|95.0|-0.24|0.62||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.62|-0.24|
71796878|NCT02272413|143092623|EQUIVALENCE|Additional analysis of the primary endpoint was performed for Japan according to a local protocol amendment Japan. For the submission in Japan, to conclude on equivalence, the 2-sided 95% CI for the ratio of best ORR between the treatments had to be entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||TWO_SIDED|95.0|0.7543|0.97|||Log-binomial regression|||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).||0.9700|0.7543|
71840364|NCT05698875|143190029|OTHER||Mean Difference (Final Values)|-24.4||||0.03|TWO_SIDED|95.0|-41.0|-8.0||A priori threshold for statistical significance is p\<0.05 P adjusted using Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-8|-41|0.03
71840365|NCT05698875|143190029|OTHER||Mean Difference (Final Values)|12.7||||0.14|TWO_SIDED|95.0|-4.1|29.5||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||29.5|-4.1|0.14
71840366|NCT05698875|143190029|OTHER||Mean Difference (Final Values)|17.0||||0.34|TWO_SIDED|95.0|3.1|31.7||A priori threshold P \<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||31.7|3.1|0.34
71893307|NCT04321343|143307583|SUPERIORITY||Mean Difference (Final Values)|2.459|STANDARD_ERROR_OF_MEAN|0.879||0.0056|TWO_SIDED|95.0|0.7268|4.1907|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||4.1907|0.7268|0.0056
71840367|NCT05698875|143190029|OTHER||Mean Difference (Final Values)|-19.0||||0.07|TWO_SIDED|95.0|-33.3|-4.7||A priori threshold for statistical significance is p\<0.05 Adjusted P value with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-4.7|-33.3|0.07
71893308|NCT04321343|143307583|SUPERIORITY||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.858||0.4288|TWO_SIDED|95.0|-1.0111|2.372|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.3720|-1.0111|0.4288
71893309|NCT04321343|143307584|SUPERIORITY||Mean Difference (Final Values)|-1.251|STANDARD_ERROR_OF_MEAN|1.093||0.2564|TWO_SIDED|95.0|-3.4307|0.9295|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.9295|-3.4307|0.2564
71893310|NCT04321343|143307584|SUPERIORITY||Mean Difference (Final Values)|-1.598|STANDARD_ERROR_OF_MEAN|1.021||0.1222|TWO_SIDED|95.0|-3.6348|0.4392|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||0.4392|-3.6348|0.1222
71893311|NCT04321343|143307584|SUPERIORITY||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.936||0.0206|TWO_SIDED|95.0|-4.088|-0.351|||Regression, Linear||Mean difference (final values) is the difference in LS Means estimated in the linear regression.|||-0.3510|-4.0880|0.0206
71673851|NCT00529373|142866187|OTHER||Difference in Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.08|0.15||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.15|-0.08|
71673852|NCT00529373|142866187|OTHER||Difference in Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.06|0.21||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.21|-0.06|
71673853|NCT00529373|142866187|OTHER||Difference in Least Squares Means|0.03|||||TWO_SIDED|95.0|-0.12|0.17||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.17|-0.12|
71673854|NCT00529373|142866187|OTHER||Difference in Least Squares Means|0.09|||||TWO_SIDED|95.0|-0.09|0.28||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).||0.28|-0.09|
71673855|NCT00529373|142866188|OTHER|Miettinen \& Nurminen|Difference in rates|1.52|||||TWO_SIDED|95.0|-1.8|4.84||||||||4.84|-1.8|
71840368|NCT05698875|143190029|OTHER||Mean Difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-51.0|-21.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGLP vs MGL meals||-21.8|-51.0|<0.001
71840369|NCT05698875|143190030|OTHER||Mean Difference (Final Values)|151.0||||0.25|TWO_SIDED|95.0|7.0|294.0||A priori threshold for statistical significance is p\<0.05 Adjusted p value with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||294|7|0.25
71893312|NCT04321343|143307585|SUPERIORITY||Odds Ratio (OR)|1.51||||0.5221|TWO_SIDED|95.0|0.436|5.201|||Cochran-Mantel-Haenszel|||||5.201|0.436|0.5221
71840370|NCT05698875|143190030|OTHER||Mean Difference (Final Values)|-109.0||||0.15|TWO_SIDED|95.0|-256.0|38.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||38|-256|0.15
71840371|NCT05698875|143190030|OTHER||Mean Difference (Final Values)|-30.0||||0.69|TWO_SIDED|95.0|-177.0|117.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||117|-177|0.69
71840372|NCT05698875|143190030|OTHER||Mean Difference (Final Values)|264.0|||<|0.001|TWO_SIDED|95.0|126.0|401.0||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs HGLP meals||401|126|<0.001
71840373|NCT05698875|143190030|OTHER||Mean Difference (Final Values)|192.0||||0.02|TWO_SIDED|95.0|56.0|329.0||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||329|56|0.02
71840374|NCT05698875|143190030|OTHER||Mean Difference (Final Values)|-71.0||||0.32|TWO_SIDED|95.0|-211.0|69.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||69|-211|0.32
71840375|NCT05698875|143190031|OTHER||Mean Difference (Final Values)|6.9|||<|0.01|TWO_SIDED|95.0|3.3|10.4||A priori threshold for statistical significance is p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meals||10.4|3.3|<0.01
71840376|NCT05698875|143190031|OTHER||Mean Difference (Final Values)|3.5||||0.06|TWO_SIDED|95.0|-0.2|7.2||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||7.2|-0.2|0.06
71893313|NCT04321343|143307585|SUPERIORITY||Odds Ratio (OR)|1.62||||0.4828|TWO_SIDED|95.0|0.434|6.012|||Cochran-Mantel-Haenszel|||||6.012|0.434|0.4828
71893314|NCT04321343|143307585|SUPERIORITY||Odds Ratio (OR)|2.87||||0.0914|TWO_SIDED|95.0|0.853|9.636|||Cochran-Mantel-Haenszel|||||9.636|0.853|0.0914
71893315|NCT04321343|143307586|SUPERIORITY||Odds Ratio (OR)|2.71||||0.1854|TWO_SIDED|95.0|0.628|11.679|||Cochran-Mantel-Haenszel|||||11.679|0.628|0.1854
71893316|NCT04321343|143307586|SUPERIORITY||Odds Ratio (OR)|4.11||||0.0562|TWO_SIDED|95.0|0.959|17.594|||Cochran-Mantel-Haenszel|||||17.594|0.959|0.0562
71796879|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.99|1.37|||Score exact method|||At least 1 AE selected for comparability assessment, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.37|0.99|
71796880|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.88|1.88|||Score exact method|||Infusion reactions, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.88|0.88|
71796881|NCT02272413|143092624|OTHER||Risk Ratio|1.2|||||TWO_SIDED|95.0|0.64|2.32|||Score exact method|||Thromboembolic events, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.32|0.64|
71796882|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.51|2.76|||Score exact method|||Febrile neutropenia, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||2.76|0.51|
71796883|NCT02272413|143092624|OTHER||Risk Ratio (RR)|3.43|||||TWO_SIDED|95.0|0.79|32.82|||Score exact method|||Gastrointestinal perforations, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||32.82|0.79|
71796884|NCT02272413|143092624|OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.66|1.39|||Score exact method|||Hypertension, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.39|0.66|
71796885|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.74|1.57|||Score exact method|||Proteinuria, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.57|0.74|
71840377|NCT05698875|143190031|OTHER||Mean Difference (Final Values)|0.32||||0.86|TWO_SIDED|95.0|-3.3|3.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||3.9|-3.3|0.86
71840378|NCT05698875|143190031|OTHER||Mean Difference (Final Values)|3.4||||0.11|TWO_SIDED|95.0|0.24|6.48||A priori threshold for statistical significance is p\<0.05 P value adjusted with the Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||6.48|0.24|0.11
71893317|NCT04321343|143307586|SUPERIORITY||Odds Ratio (OR)|1.53||||0.5223|TWO_SIDED|95.0|0.398|5.88|||Cochran-Mantel-Haenszel|||||5.880|0.398|0.5223
71893318|NCT04321343|143307587|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.891||0.7532|TWO_SIDED|95.0|-1.4749|2.0356|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||2.0356|-1.4749|0.7532
71893319|NCT04321343|143307587|SUPERIORITY||Mean Difference (Final Values)|1.985|STANDARD_ERROR_OF_MEAN|0.858||0.0216|TWO_SIDED|95.0|0.2946|3.6763|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||3.6763|0.2946|0.0216
71673856|NCT00529373|142866189|OTHER|Miettinen \& Nurminen|Difference in rates|0.27|||||TWO_SIDED|95.0|-0.04|0.58||||||||0.58|-0.04|
71673857|NCT00529373|142866190|OTHER||Hazard Ratio (HR)|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.4|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.40|0.19|<0.001
71673858|NCT00529373|142866191|OTHER||Difference in Least Squares Means|0.01||||0.041|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|||Odanacatib 50 mg OW versus Placebo. The mixed model contained fixed effects for treatment, region, stratum, treatment-year interaction and random effect intercept and slope (year) and unstructured covariance matrix.||0.03|0.00|0.041
71673859|NCT00529373|142866192|OTHER||Odds Ratio (OR)|0.89||||0.014|TWO_SIDED|95.0|0.81|0.98|||Logistic model|||Odanacatib 50 mg OW versus Placebo. Treatment comparison for height loss at any time during the treatment period. The logistic model contained terms for treatment, geographic region and stratum.||0.98|0.81|0.014
71673860|NCT00529373|142866193|OTHER||Difference in Least Squares Means|1.32|||<|0.001|TWO_SIDED|95.0|0.9|1.75|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.75|0.90|<0.001
71673861|NCT00529373|142866193|OTHER||Difference in Least Squares Means|2.49|||<|0.001|TWO_SIDED|95.0|2.37|2.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.61|2.37|<0.001
71673862|NCT00529373|142866193|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
71796886|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.28|10.79|||Score exact method|||Pulmonary haemorrhage, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||10.79|0.28|
71796887|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.24|||||TWO_SIDED|95.0|0.88|1.74|||Score exact method|||Other hemorrhages, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||1.74|0.88|
71796888|NCT02272413|143092624|OTHER||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.47|3.57|||Score excat method|||Wound healing complications/ abscesses/ fistulas, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where 'a' was the number of patients with TEAEs selected for comparability within treatment group X, 'a+b' was the total number of patients in treatment group X, 'c' was the number of patients with TEAEs selected for comparability within treatment group Y and 'c+d' was the total number of patients in treatment group Y.||3.57|0.47|
71840379|NCT05698875|143190031|OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.6|9.8||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni did not alter p value|Linear Mixed Model|||HGL vs MGL meals||9.8|3.6|<0.001
71673863|NCT00529373|142866193|OTHER||Difference in Least Squares Means|6.44|||<|0.001|TWO_SIDED|95.0|6.25|6.64|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.64|6.25|<0.001
71673864|NCT00529373|142866193|OTHER||Difference in Least Squares Means|8.62|||<|0.001|TWO_SIDED|95.0|8.11|9.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.12|8.11|<0.001
71673865|NCT00529373|142866193|OTHER||Difference in Least Squares Means|9.49|||<|0.001|TWO_SIDED|95.0|8.7|10.29|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.29|8.70|<0.001
71673866|NCT00529373|142866194|OTHER||Difference in Least Squares Means|2.96|||<|0.001|TWO_SIDED|95.0|2.47|3.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.46|2.47|<0.001
71673867|NCT00529373|142866194|OTHER||Difference in Least Squares Means|4.07|||<|0.001|TWO_SIDED|95.0|3.93|4.22|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.22|3.93|<0.001
71673868|NCT00529373|142866194|OTHER||Difference in Least Squares Means|6.05|||<|0.001|TWO_SIDED|95.0|5.87|6.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.23|5.87|<0.001
71673869|NCT00529373|142866194|OTHER||Difference in Least Squares Means|7.84|||<|0.001|TWO_SIDED|95.0|7.62|8.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.06|7.62|<0.001
71673870|NCT00529373|142866194|OTHER||Difference in Least Squares Means|9.72|||<|0.001|TWO_SIDED|95.0|9.16|10.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.27|9.16|<0.001
71840380|NCT05698875|143190031|OTHER||Mean Difference (Final Values)|3.3||||0.13|TWO_SIDED|95.0|0.2|6.5||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGLP vs MGL meals||6.5|0.2|0.13
71796889|NCT02272413|143092625|OTHER||Hazard Ratio (HR)|1.22|||||TWO_SIDED|95.0|1.02|1.45|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.45|1.02|
71796890|NCT02272413|143092626|OTHER||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|1.0|1.51|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.51|1.00|
71796891|NCT02272413|143092627|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.88|1.48|||Cox-proportional hazards regression|||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).||1.48|0.88|
71796892|NCT01461096|143092637|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.35|TWO_SIDED|95.1|0.47|1.31||P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.|generalized log-rank test (Sun 1996)|The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.|qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.|||1.31|0.47|0.350
71796893|NCT01077960|143092654|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71796894|NCT01077960|143092655|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71796895|NCT01077960|143092656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71796896|NCT01077960|143092657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71796897|NCT01077960|143092658|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
71893320|NCT04321343|143307587|SUPERIORITY||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.838||0.7893|TWO_SIDED|95.0|-1.4283|1.8771|||Mixed Models Analysis|Mixed Model Repeated Measures|Mean difference (final values) is the difference in LS Means estimated in the MMRM model.|||1.8771|-1.4283|0.7893
71796898|NCT01077960|143092659|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71796899|NCT01465464|143092667|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.435|TWO_SIDED|95.0|0.878|1.352|||Log Rank|||||1.352|0.878|0.435
71796900|NCT01554618|143092673|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.33||0.012|TWO_SIDED|95.0|-1.51|-0.19|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline HbA1c value (continuous) and baseline HbA1c by visit interaction as fixed effects, using an unstructured covariance matrix.||-0.19|-1.51|0.012
71796901|NCT01554618|143092676|SUPERIORITY||LS Mean Difference|-21.6|STANDARD_ERROR_OF_MEAN|13.7||0.119|TWO_SIDED|95.0|-49.0|5.7|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline fasting plasma glucose value, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting plasma glucose by visit interaction as fixed effects, using an unstructured covariance matrix.||5.7|-49.0|0.119
71796902|NCT01554618|143092677|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|1.189||0.307|TWO_SIDED|95.0|-3.59|1.15|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, and treatment group by visit interaction, baseline body weight, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline body weight by visit interaction as fixed effects, using an unstructured covariance matrix.||1.15|-3.59|0.307
71893321|NCT04194944|143307588|SUPERIORITY||Hazard Ratio (HR)|0.465||||0.0002|TWO_SIDED|95.0|0.309|0.699|||Log Rank|||||0.699|0.309|0.0002
71893322|NCT04194944|143307589|SUPERIORITY||Hazard Ratio (HR)|0.482||||0.0001|TWO_SIDED|95.0|0.331|0.7|||Log Rank|||||0.700|0.331|0.0001
71893323|NCT04194944|143307590|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3996|TWO_SIDED|95.0|0.7|3.4|||Cochran-Mantel-Haenszel|||||3.4|0.7|0.3996
71893324|NCT04194944|143307591|SUPERIORITY||Odds Ratio (OR)|1.7||||0.139|TWO_SIDED|95.0|0.9|3.6|||Cochran-Mantel-Haenszel|||||3.6|0.9|0.1390
71893325|NCT04194944|143307594|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0028|TWO_SIDED|95.0|1.4|5.1|||Cochran-Mantel-Haenszel|||||5.1|1.4|0.0028
71893326|NCT04194944|143307595|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0003|TWO_SIDED|95.0|1.6|5.2|||Cochran-Mantel-Haenszel|||||5.2|1.6|0.0003
71893327|NCT04194944|143307596|SUPERIORITY||Hazard Ratio (HR)|0.377||||0.0001|TWO_SIDED|95.0|0.224|0.633|||Log Rank|||||0.633|0.224|0.0001
71893328|NCT04194944|143307597|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.0004|TWO_SIDED|95.0|0.256|0.684|||Log Rank|||||0.684|0.256|0.0004
71893329|NCT04194944|143307600|SUPERIORITY||Odds Ratio (OR)|3.2||||0.1809|TWO_SIDED|95.0|0.8|12.8|||Cochran-Mantel-Haenszel|||||12.8|0.8|0.1809
71893330|NCT04194944|143307601|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0167|TWO_SIDED|95.0|1.4|19.6|||Cochran-Mantel-Haenszel|||||19.6|1.4|0.0167
71893331|NCT05224258|143307645|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.2|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.1|-0.4|<0.001
71893332|NCT05224258|143307645|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint.|||-0.2|-0.5|<0.001
71673871|NCT00529373|142866194|OTHER||Difference in Least Squares Means|11.23|||<|0.001|TWO_SIDED|95.0|10.23|12.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.23|10.23|<0.001
71673872|NCT00529373|142866195|OTHER||Difference in Least Squares Means|1.49|||<|0.001|TWO_SIDED|95.0|0.95|2.03|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.03|0.95|<0.001
71673873|NCT00529373|142866195|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
71673874|NCT00529373|142866195|OTHER||Difference in Least Squares Means|4.38|||<|0.001|TWO_SIDED|95.0|4.19|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.19|<0.001
71673875|NCT00529373|142866195|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.24|6.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.68|6.24|<0.001
71673876|NCT00529373|142866195|OTHER||Difference in Least Squares Means|8.42|||<|0.001|TWO_SIDED|95.0|7.82|9.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.02|7.82|<0.001
71673877|NCT00529373|142866195|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|7.54|9.53|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.53|7.54|<0.001
71673878|NCT00529373|142866196|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.03|2.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.46|1.03|<0.001
71796903|NCT01554618|143092678|SUPERIORITY||LS Mean Difference|94.9|STANDARD_ERROR_OF_MEAN|95.26||0.323|TWO_SIDED|95.0|-95.6|285.5|||Mixed Models Analysis||Exenatide versus Placebo|Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline fasting insulin, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline fasting insulin by visit interaction as fixed effects, using an unstructured covariance matrix.||285.5|-95.6|0.323
71673879|NCT00529373|142866196|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
71796904|NCT01554618|143092679|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
71796905|NCT01554618|143092679|SUPERIORITY||Difference|14.8||||0.077|TWO_SIDED|95.0|1.9|27.7|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c ≤ 6.5%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||27.7|1.9|0.077
71673880|NCT00529373|142866196|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.17|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.17|<0.001
71673881|NCT00529373|142866196|OTHER||Difference in Least Squares Means|9.27|||<|0.001|TWO_SIDED|95.0|8.98|9.57|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 36||9.57|8.98|<0.001
71673882|NCT00529373|142866196|OTHER||Difference in Least Squares Means|12.44|||<|0.001|TWO_SIDED|95.0|11.66|13.22|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 48||13.22|11.66|<0.001
71673883|NCT00529373|142866196|OTHER||Difference in Least Squares Means|13.81|||<|0.001|TWO_SIDED|95.0|12.58|15.04|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60||15.04|12.58|<0.001
71673884|NCT00529373|142866197|OTHER||Difference in Least Squares Means|1.11|||<|0.001|TWO_SIDED|95.0|0.67|1.55|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.55|0.67|<0.001
71673885|NCT00529373|142866197|OTHER||Difference in Least Squares Means|1.35|||<|0.001|TWO_SIDED|95.0|0.85|1.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.84|0.85|<0.001
71673886|NCT00529373|142866197|OTHER||Difference in Least Squares Means|1.93|||<|0.001|TWO_SIDED|95.0|1.38|2.47|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.47|1.38|<0.001
71796906|NCT01554618|143092679|SUPERIORITY||Difference|22.7||||0.02|TWO_SIDED|95.0|6.5|39.0|||Cochran-Mantel-Haenszel||Exenatide versus Placebo. Difference was the risk difference of the 2 proportions.|"Treatment difference in HbA1c \< 7.0%:~Treatment group comparison was based on CMH test stratified by screening HbA1c (\<9.0% or \>=9.0%). P-value was from the general association statistic."||39.0|6.5|0.020
71796907|NCT01554618|143092681|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|2.61||0.284|TWO_SIDED|95.0|-8.0|2.4|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in SBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline SBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline SBP by visit interaction as fixed effects, using an unstructured covariance matrix."||2.4|-8.0|0.284
71796908|NCT01554618|143092681|SUPERIORITY||LS Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.77||0.376|TWO_SIDED|95.0|-2.0|5.1|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in DBP:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline DBP, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline DBP by visit interaction as fixed effects, using an unstructured covariance matrix."||5.1|-2.0|0.376
71796909|NCT01554618|143092683|SUPERIORITY||LS Mean Difference|90.37|STANDARD_ERROR_OF_MEAN|69.207||0.211|TWO_SIDED|95.0|-57.27|238.0|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-B:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-B, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-B by visit interaction as fixed effects, using an unstructured covariance matrix."||238.00|-57.27|0.211
71796910|NCT01554618|143092683|SUPERIORITY||LS Mean Difference|-6.75|STANDARD_ERROR_OF_MEAN|6.173||0.289|TWO_SIDED|95.0|-19.8|6.29|||Mixed Models Analysis||Exenatide versus Placebo|"Treatment difference in HOMA-S:~Adjusted LS mean and treatment group difference in the change from baseline at Week 24 were modeled using a MMRM including treatment group, region, visit, treatment group by visit interaction, baseline HOMA-S, screening HbA1c (\< 9.0% or ≥ 9.0%), and baseline HOMA-S by visit interaction as fixed effects, using an unstructured covariance matrix."||6.29|-19.80|0.289
71796911|NCT00847288|143092717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.0043|TWO_SIDED|95.0|1.1|2.0||Cox proportional hazard model was fitted with the group effect and other key baseline variables. The p-value for the main group effect is 0.0043, with an estimated hazard ratio of 1.5, monthly vs quarterly.|Regression, Cox|||"Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio."||2.0|1.1|0.0043
71796912|NCT00847288|143092719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0001|TWO_SIDED|95.0|1.2|1.74|||logistic GEE for repeated observations|||The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.||1.74|1.20|0.0001
71796913|NCT04448210|143092721|SUPERIORITY||||||<|0.25|||||||ANOVA|||||||<.25
71796914|NCT04448210|143092722|SUPERIORITY|||||||0.72|||||||ANOVA|||||||.72
71796915|NCT04448210|143092723|SUPERIORITY|||||||0.16|||||||ANOVA|||||||.16
71796916|NCT04448210|143092724|SUPERIORITY|||||||0.43|||||||ANOVA|||||||.43
71673887|NCT00529373|142866197|OTHER||Difference in Least Squares Means|2.2||||0.001|TWO_SIDED|95.0|0.89|3.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.51|0.89|0.001
71796917|NCT04448210|143092725|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
71796918|NCT04448210|143092726|SUPERIORITY|||||||0.38|||||||ANOVA|||||||.38
71796919|NCT04448210|143092727|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
71796920|NCT04448210|143092728|SUPERIORITY|||||||0.94|||||||ANOVA|||||||.94
71796921|NCT04448210|143092729|SUPERIORITY|||||||0.3|||||||ANOVA|||||||.30
71796922|NCT02540954|143092930|NON_INFERIORITY|Non-inferiority margin is 5 letters.|Least squares mean difference|0.22|||<|0.0001|TWO_SIDED|95.0|-1.51|1.96|||ANCOVA|||||1.96|-1.51|< 0.0001
71796923|NCT02540954|143092931|NON_INFERIORITY|Non inferiority margin is 7%.|Treatment difference in %|1.1|||||TWO_SIDED|95.0|-3.7|6.0||||||||6.0|-3.7|
71796924|NCT02540954|143092936|OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-4.152|0.392||||||||0.392|-4.152|
71796925|NCT01393743|143092950|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-30.81||||0.0001|TWO_SIDED|95.0|-45.49|-15.244||The P-value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-15.244|-45.49|0.0001
71796926|NCT01393743|143092951|SUPERIORITY_OR_OTHER|||||||0.0019||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.0019
71796927|NCT01393743|143092953|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-23.45||||0.0018|TWO_SIDED|95.0|-40.668|-8.518||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.||-8.518|-40.668|0.0018
71796928|NCT01393743|143092954|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-12.25||||0.3478|TWO_SIDED|95.0|-53.054|26.989||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|Median Difference to Placebo for Absence Seizures||26.989|-53.054|0.3478
71673888|NCT00529373|142866197|OTHER||Difference in Least Squares Means|3.5||||0.001|TWO_SIDED|95.0|1.46|5.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||5.54|1.46|0.001
71673889|NCT00529373|142866198|OTHER||Difference in Least Squares Means|5.79|||<|0.001|TWO_SIDED|95.0|5.37|6.2|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.2|5.37|<0.001
71673890|NCT00529373|142866198|OTHER||Difference in Least Squares Means|4.02|||<|0.001|TWO_SIDED|95.0|3.67|4.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.37|3.67|<0.001
71673891|NCT00529373|142866198|OTHER||Difference in Least Squares Means|7.62|||<|0.001|TWO_SIDED|95.0|7.11|8.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.13|7.11|<0.001
71673892|NCT00529373|142866198|OTHER||Difference in Least Squares Means|9.51|||<|0.001|TWO_SIDED|95.0|7.96|11.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.06|7.96|<0.001
71673893|NCT00529373|142866199|OTHER||Difference in Least Squares Means|2.4|||<|0.001|TWO_SIDED|95.0|2.11|2.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.68|2.11|<0.001
71673894|NCT00529373|142866199|OTHER||Difference in Least Squares Means|4.21|||<|0.001|TWO_SIDED|95.0|3.84|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|3.84|<0.001
71796929|NCT01393743|143092954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.87||||0.61|TWO_SIDED|95.0|-15.338|59.938|||ANCOVA|||Median Difference to Placebo for Myoclonic Seizure||59.938|-15.338|0.61
71796930|NCT01393743|143092955|SUPERIORITY_OR_OTHER|||||||0.1826||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel|||||||0.1826
71673895|NCT00529373|142866199|OTHER||Difference in Least Squares Means|5.86|||<|0.001|TWO_SIDED|95.0|5.41|6.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.30|5.41|<0.001
71796931|NCT01393743|143092956|SUPERIORITY_OR_OTHER|||||||0.4653|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Absence Seizures||||0.4653
71796932|NCT01393743|143092956|SUPERIORITY_OR_OTHER|||||||0.3694|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Myoclonic Seizures||||0.3694
71893333|NCT05224258|143307646|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7|||<|0.001|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|<0.001
71673896|NCT00529373|142866199|OTHER||Difference in Least Squares Means|8.54|||<|0.001|TWO_SIDED|95.0|7.0|10.09|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.09|7.00|<0.001
71673897|NCT00529373|142866200|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|1.83|2.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.59|1.83|<0.001
71796933|NCT02321462|143092971|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence intervals (CI) of the difference was higher than the predefined noninferiority margin (-15%).|Adjusted difference|-0.46|||||TWO_SIDED|95.0|-4.22|3.29|||||To investigate noninferiority of Eziclen compared to Fortrans®, the adjusted difference between these 2 groups was calculated with 95% CI of the adjusted difference.|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status (No IBD, IBD) was used.||3.29|-4.22|
71796934|NCT02321462|143092972|SUPERIORITY||Adjusted difference|0.15|||=|0.0249|TWO_SIDED|95.0|0.02|0.28|||ANOVA|A 2-way analysis of variance model (ANOVA) with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score.||0.28|0.02|=0.0249
71796935|NCT02321462|143092972|SUPERIORITY||Adjusted difference|0.11|||=|0.0382|TWO_SIDED|95.0|0.01|0.22|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score.||0.22|0.01|=0.0382
71796936|NCT02321462|143092972|SUPERIORITY||Adjusted difference|0.06|||=|0.2538|TWO_SIDED|95.0|-0.04|0.16|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Left Colon BBPS Score.||0.16|-0.04|=0.2538
71796937|NCT02321462|143092972|SUPERIORITY||Adjusted difference|0.33|||=|0.0256|TWO_SIDED|95.0|0.04|0.62|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Global BBPS Score.||0.62|0.04|=0.0256
71673898|NCT00529373|142866200|OTHER||Difference in Least Squares Means|4.33|||<|0.001|TWO_SIDED|95.0|3.87|4.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.78|3.87|<0.001
71840381|NCT05698875|143190032|OTHER||Mean Difference (Final Values)|-34.8||||0.01|TWO_SIDED|95.0|-55.9|-13.6||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL meals vs control meal||-13.6|-55.9|0.01
71840382|NCT05698875|143190032|OTHER||Mean Difference (Final Values)|-1.8||||0.87|TWO_SIDED|95.0|-23.6|19.9||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||19.9|-23.6|0.87
71840383|NCT05698875|143190032|OTHER||Mean Difference (Final Values)|-4.7||||0.67|TWO_SIDED|95.0|-26.4|17.0||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||MGL meals vs control meals||17.0|-26.4|0.67
71840384|NCT05698875|143190032|OTHER||Mean Difference (Final Values)|-33.3||||0.01|TWO_SIDED|95.0|-54.4|-12.2||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs HGLP meals||-12.2|-54.4|0.01
71840385|NCT05698875|143190032|OTHER||Mean Difference (Final Values)|-31.4||||0.01|TWO_SIDED|95.0|-52.4|-10.4||A priori threshold for statistical significance is p\<0.05 Adjustment with Bonferroni correction|Linear Mixed Model|||HGL vs MGL meals||-10.4|-52.4|0.01
71840386|NCT05698875|143190032|OTHER||Mean Difference (Final Values)|1.86||||0.87|TWO_SIDED|95.0|-19.7|23.4||A priori threshold for statistical significance is p\<0.05|Linear Mixed Model|||HGLP vs MGL meals||23.4|-19.7|0.87
71840387|NCT05698875|143190033|OTHER||Mean Difference (Final Values)|34.0||||0.04|TWO_SIDED|95.0|2.0|65.0|||t-test, 2 sided|||Control vs HGL meals||65|2|0.04
71840388|NCT05698875|143190033|OTHER||Mean Difference (Final Values)|6.0||||0.56|TWO_SIDED|95.0|-17.0|30.0|||t-test, 2 sided|||Control vs HGLP meals||30|-17|0.56
71840389|NCT05698875|143190033|OTHER||Mean Difference (Final Values)|12.0||||0.22|TWO_SIDED|95.0|8.0|32.0|||t-test, 2 sided|||Control vs MGL meals||32|8|0.22
71840390|NCT05698875|143190033|OTHER||Mean Difference (Final Values)|38.0||||0.01|TWO_SIDED|95.0|10.0|67.0|||t-test, 2 sided|||HGL vs HGLP meals||67|10|0.01
71840391|NCT05698875|143190033|OTHER||Mean Difference (Final Values)|33.0||||0.03|TWO_SIDED|95.0|4.0|62.0|||t-test, 2 sided|||HGL vs MGL meals||62|4|0.03
71840392|NCT05698875|143190033|OTHER||Mean Difference (Final Values)|-5.0||||0.63|TWO_SIDED|95.0|-29.0|18.0|||t-test, 2 sided|||HGLP vs MGL meals||18|-29|0.63
71840393|NCT05698875|143190034|OTHER||Mean Difference (Final Values)|22.0||||0.16|TWO_SIDED|95.0|10.0|53.0|||t-test, 2 sided|||Control vs HGL meals||53|10|0.16
71840394|NCT05698875|143190034|OTHER||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED|95.0|5.0|46.0|||t-test, 2 sided|||Control vs HGLP meals||46|5|0.11
71840395|NCT05698875|143190034|OTHER||Mean Difference (Final Values)|19.0||||0.15|TWO_SIDED|95.0|8.0|45.0|||t-test, 2 sided|||Control vs MGL meals||45|8|0.15
71840396|NCT05698875|143190034|OTHER||Mean Difference (Final Values)|44.0|||<|0.01|TWO_SIDED|95.0|16.0|71.0|||t-test, 2 sided|||HGL vs HGLP meals||71|16|<0.01
71840397|NCT05698875|143190034|OTHER||Mean Difference (Final Values)|-7.0||||0.6|TWO_SIDED|95.0|-36.0|21.0|||t-test, 2 sided|||HGL vs MGL meals||21|-36|0.60
71840398|NCT05698875|143190034|OTHER||Mean Difference (Final Values)|29.0||||0.02|TWO_SIDED|95.0|6.0|51.0|||t-test, 2 sided|||HGLP vs MGL meals||51|6|0.02
71840399|NCT05698875|143190035|OTHER||Mean Difference (Final Values)|1.6|||<|0.001|TWO_SIDED|95.0|0.8|2.4||The a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal excursion vs Control meal at 30 minutes||2.4|0.8|<0.001
71840400|NCT05698875|143190035|OTHER||Mean Difference (Final Values)|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.2|||Linear Mixed Model|||HGLP meal vs Control meal glucose excursion at 30 minutes||1.2|-0.5|0.38
71840401|NCT05698875|143190035|OTHER||Mean Difference (Final Values)|-0.3||||0.47|TWO_SIDED|95.0|-1.1|0.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meal excursion vs Control meal at 30 minutes||0.5|-1.1|0.47
71840402|NCT05698875|143190035|OTHER||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.5|2.0||a priori threshold for statistical significance p\<0.05 P value adjusted with Bonferroni correction|Linear Mixed Model|||HGL meal vs HGLP meal||2.0|0.5|0.01
71840403|NCT05698875|143190035|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|1.1|2.6||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meal vs MGL meals||2.6|1.1|<0.001
71840404|NCT05698875|143190035|OTHER||Mean Difference (Final Values)|0.7||||0.09|TWO_SIDED|95.0|0.1|1.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs MGL meals||1.4|0.1|0.09
71840405|NCT05698875|143190036|OTHER||Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|0.7|3.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||3.0|0.7|<0.001
71840406|NCT05698875|143190036|OTHER||Mean Difference (Final Values)|-0.1||||0.87|TWO_SIDED|95.0|-1.2|1.0||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||1.0|-1.2|0.87
71840407|NCT05698875|143190036|OTHER||Mean Difference (Final Values)|-0.4||||0.48|TWO_SIDED|95.0|-1.5|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||0.7|-1.5|0.48
71840408|NCT05698875|143190036|OTHER||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|1.0|3.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs HGLP meals||3.1|1.0|<0.001
71840409|NCT05698875|143190036|OTHER||Mean Difference (Final Values)|2.4|||<|0.001|TWO_SIDED|95.0|1.3|3.4||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||3.4|1.3|<0.001
71840410|NCT05698875|143190036|OTHER||Mean Difference (Final Values)|-0.34||||0.53|TWO_SIDED|95.0|-1.4|0.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||0.7|-1.4|0.53
71840411|NCT05698875|143190037|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.03|2.7||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.7|-0.03|0.06
71840412|NCT05698875|143190037|OTHER||Mean Difference (Final Values)|-1.1||||0.13|TWO_SIDED|95.0|-2.5|0.3||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.3|-2.5|0.13
71840413|NCT05698875|143190037|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.5|0.82
71840414|NCT05698875|143190037|OTHER||Mean Difference (Final Values)|2.4|||<|0.01|TWO_SIDED|95.0|1.1|3.7||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||3.7|1.1|<0.01
71673899|NCT00529373|142866200|OTHER||Difference in Least Squares Means|6.09|||<|0.001|TWO_SIDED|95.0|5.56|6.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.62|5.56|<0.001
71673900|NCT00529373|142866200|OTHER||Difference in Least Squares Means|9.08|||<|0.001|TWO_SIDED|95.0|6.97|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|6.97|<0.001
71673901|NCT00529373|142866201|OTHER||Difference in Least Squares Means|3.44|||<|0.001|TWO_SIDED|95.0|2.98|3.9|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 12||3.90|2.98|<0.001
71673902|NCT00529373|142866201|OTHER||Difference in Least Squares Means|6.03|||<|0.001|TWO_SIDED|95.0|5.47|6.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.59|5.47|<0.001
71673903|NCT00529373|142866201|OTHER||Difference in Least Squares Means|8.49|||<|0.001|TWO_SIDED|95.0|7.81|9.16|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.16|7.81|<0.001
71673904|NCT00529373|142866201|OTHER||Difference in Least Squares Means|11.76|||<|0.001|TWO_SIDED|95.0|9.15|14.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||14.36|9.15|<0.001
71673905|NCT00529373|142866202|OTHER||Difference in Least Squares Means|1.08||||0.083|TWO_SIDED|95.0|-0.14|2.31|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.31|-0.14|0.083
71673906|NCT00529373|142866202|OTHER||Difference in Least Squares Means|1.05||||0.129|TWO_SIDED|95.0|-0.31|2.4|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.40|-0.31|0.129
71673907|NCT00529373|142866202|OTHER||Difference in Least Squares Means|1.21||||0.104|TWO_SIDED|95.0|-0.25|2.67|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.67|-0.25|0.104
71673908|NCT00529373|142866202|OTHER||Difference in Least Squares Means|1.55||||0.617|TWO_SIDED|95.0|-4.92|8.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.02|-4.92|0.617
71673909|NCT00529373|142866203|OTHER||Difference in Least Squares Means|-58.99|||<|0.001|TWO_SIDED|95.0|-64.68|-53.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-53.30|-64.68|<0.001
71673910|NCT00529373|142866203|OTHER||Difference in Least Squares Means|-60.01|||<|0.001|TWO_SIDED|95.0|-66.4|-53.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-53.61|-66.40|<0.001
71673911|NCT00529373|142866203|OTHER||Difference in Least Squares Means|-46.7|||<|0.001|TWO_SIDED|95.0|-53.23|-40.17|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-40.17|-53.23|<0.001
71673912|NCT00529373|142866203|OTHER||Difference in Least Squares Means|-44.67||||0.05|TWO_SIDED|95.0|-52.62|-36.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-36.72|-52.62|0.050
71893334|NCT05224258|143307646|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% with a margin of 7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
71673913|NCT00529373|142866203|OTHER||Difference in Least Squares Means|-18.73||||0.05|TWO_SIDED|95.0|-37.44|-0.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-0.01|-37.44|0.050
71673914|NCT00529373|142866204|OTHER||Difference in Least Squares Means|-51.7|||<|0.001|TWO_SIDED|95.0|-56.11|-47.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.||-47.28|-56.11|<0.001
71673915|NCT00529373|142866204|OTHER||Difference in Least Squares Means|-53.59|||<|0.001|TWO_SIDED|95.0|-58.39|-48.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.||-48.79|-58.39|<0.001
71673916|NCT00529373|142866204|OTHER||Difference in Least Squares Means|-56.68|||<|0.001|TWO_SIDED|95.0|-62.52|-50.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.||-50.84|-62.52|<0.001
71893335|NCT05224258|143307647|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.3|<0.001
71673917|NCT00529373|142866204|OTHER||Difference in Least Squares Means|-59.14|||<|0.001|TWO_SIDED|95.0|-66.04|-52.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.||-52.23|-66.04|<0.001
71673918|NCT00529373|142866204|OTHER||Difference in Least Squares Means|-44.54|||<|0.001|TWO_SIDED|95.0|-61.72|-27.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.||-27.36|-61.72|<0.001
71673919|NCT00529373|142866205|OTHER||Mean Difference (Final Values)|-14.13|||<|0.001|TWO_SIDED|95.0|-17.0|-11.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.27|-17.00|<0.001
71796938|NCT02321462|143092973|SUPERIORITY||Adjusted difference|0.11|||=|0.084|TWO_SIDED|95.0|-0.02|0.24|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score (per protocol population).||0.24|-0.02|=0.0840
71796939|NCT02321462|143092973|SUPERIORITY||Treatment difference|0.08|||=|0.132|TWO_SIDED|95.0|-0.02|0.18|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score (per protocol population).||0.18|-0.02|=0.1320
71796940|NCT02321462|143092974|SUPERIORITY||Adjusted difference|-6.94|||=|0.2199|TWO_SIDED|95.0|-17.53|3.64|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of polyps.||3.64|-17.53|=0.2199
71796941|NCT02321462|143092974|SUPERIORITY||Adjusted difference|1.87|||=|0.6325|TWO_SIDED|95.0|-6.25|9.99|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of adenomas.||9.99|-6.25|=0.6325
71796942|NCT02321462|143092974|SUPERIORITY||Adjusted difference|-1.55|||=|0.7086|TWO_SIDED|95.0|-9.64|6.54|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||Treatment difference for detection of other lesions.||6.54|-9.64|=0.7086
71796943|NCT02321462|143092975|SUPERIORITY||Adjusted difference|0.01|||=|0.9927|TWO_SIDED|95.0|-3.12|3.14|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||3.14|-3.12|=0.9927
71796944|NCT02321462|143092976|SUPERIORITY||Adjusted difference|-0.3|||=|0.7039|TWO_SIDED|95.0|-1.88|1.27|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||1.27|-1.88|=0.7039
71796945|NCT02321462|143092977|SUPERIORITY||Adjusted difference|0.1|||=|0.1891|TWO_SIDED|95.0|-0.05|0.25|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; \>65), gender and IBD status was used.||||0.25|-0.05|=0.1891
71796946|NCT02321462|143092978|SUPERIORITY||Adjusted difference|13.35|||=|0.0011|TWO_SIDED|95.0|6.37|20.32|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; \>65), gender and IBD status was used.||||20.32|6.37|=0.0011
71796947|NCT05409235|143093003|SUPERIORITY||difference in percentage of participants|-1.064||||0.573|TWO_SIDED|90.0|-10.578|8.449|||Mantel Haenszel|MH test is adjusted for the randomization stratification factor (Screening DRSS score 47 or 53 or 61B).|A single imputation (non-response) when applying composite variable strategy. MI based for missing data at Week 24, assuming MAR when applying hypothetical strategy. Kept in the analysis when applying treatment policy strategy.|The study was powered to provide a 90% probability to detect a 20% difference between each treatment arm and the combined vehicle control.||8.449|-10.578|0.5730
71796948|NCT05409235|143093003|SUPERIORITY||difference in percentage of participants|-1.152||||0.575|TWO_SIDED|90.0|-11.178|8.874|||Mantel Haenszel|||||8.874|-11.178|0.5750
71796949|NCT05409235|143093004|SUPERIORITY||difference in percentage of participants|3.119||||0.7276|TWO_SIDED|90.0|-5.314|11.592|||Mantel Haenszel|||||11.592|-5.314|0.7276
71796950|NCT05409235|143093004|SUPERIORITY||difference in percentage of participants|5.779||||0.8492|TWO_SIDED|90.0|-3.424|14.982|||Mantel Haenszel|||||14.982|-3.424|0.8492
71796951|NCT05409235|143093005|SUPERIORITY||difference in percentage of participants|-1.863||||0.3097|TWO_SIDED|90.0|-8.036|4.309|||Mantel Haenszel|||||4.309|-8.036|0.3097
71796952|NCT05409235|143093005|SUPERIORITY||difference in percentage of participants|-1.596||||0.3414|TWO_SIDED|90.0|-8.021|4.829|||Mantel Haenszel|||||4.829|-8.021|0.3414
71893336|NCT05224258|143307647|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.3|||<|0.001|TWO_SIDED|95.0|0.2|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.4|0.2|<0.001
71796953|NCT05409235|143093006|SUPERIORITY||Cox Proportional Hazard|0.899||||0.397|TWO_SIDED|90.0|0.4378|1.8467|||Log Rank|||||1.8467|0.4378|0.397
71796954|NCT05409235|143093006|SUPERIORITY||Cox Proportional Hazard|1.113||||0.605|TWO_SIDED|90.0|0.5596|2.2117|||Log Rank|||||2.2117|0.5596|0.605
71796955|NCT05409235|143093007|SUPERIORITY||difference in percentage of participants|-10.622||||0.0619|TWO_SIDED|90.0|-21.972|0.728|||Mantel Haenszel|||||0.728|-21.972|0.0619
71796956|NCT05409235|143093007|SUPERIORITY||difference in percentage of participants|-4.942||||0.2483|TWO_SIDED|90.0|-16.897|7.013|||Mantel Haenszel|||||7.013|-16.897|0.2483
71796957|NCT05409235|143093008|SUPERIORITY||Cox Proportional Hazard|0.807||||0.237|TWO_SIDED|90.0|0.4675|1.392|||Log Rank|||||1.3920|0.4675|0.237
71796958|NCT05409235|143093008|SUPERIORITY||Cox Proportional Hazard|1.279||||0.766|TWO_SIDED|90.0|0.7795|2.0981|||Log Rank|||||2.0981|0.7795|0.766
71796959|NCT05409235|143093009|SUPERIORITY||difference in percentage of participants|-6.389||||0.2022|TWO_SIDED|90.0|-18.994|6.215|||Mantel Haenszel|||||6.215|-18.994|0.2022
71796960|NCT05409235|143093009|SUPERIORITY||difference in percentage of participants|-1.043||||0.4476|TWO_SIDED|90.0|-14.07|11.984|||Mantel Haenszel|||||11.984|-14.070|0.4476
71796961|NCT05409235|143093010|SUPERIORITY||Hazard Ratio (HR)|0.843||||0.268|TWO_SIDED|90.0|0.533|1.334||log-rank test stratified by randomization stratification factor|Log Rank|||||1.334|0.533|0.268
71796962|NCT05409235|143093010|SUPERIORITY||Hazard Ratio (HR)|1.145||||0.304|TWO_SIDED|90.0|0.738|1.775|||Log Rank|||||1.775|0.738|0.304
71796963|NCT05409235|143093011|SUPERIORITY||Odds Ratio (OR)|1.102||||0.428|TWO_SIDED|90.0|0.4573|2.657|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.6570|0.4573|0.428
71796964|NCT05409235|143093011|SUPERIORITY||Odds Ratio (OR)|1.119||||0.419|TWO_SIDED|90.0|0.45|2.7846|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||2.7846|0.4500|0.419
71796965|NCT05409235|143093012|SUPERIORITY||difference in percentage of participants|-1.544||||0.6716|TWO_SIDED|90.0|-7.26|4.172|||Mantel Haenszel|||||4.172|-7.260|0.6716
71796966|NCT05409235|143093012|SUPERIORITY||difference in percentage of participants|-3.412||||0.8414|TWO_SIDED|90.0|-9.025|2.2|||Mantel Haenszel|||||2.200|-9.025|0.8414
71673920|NCT00529373|142866205|OTHER||Mean Difference (Final Values)|-12.01|||<|0.001|TWO_SIDED|95.0|-15.22|-8.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-8.79|-15.22|<0.001
71673921|NCT00529373|142866205|OTHER||Mean Difference (Final Values)|-9.29|||<|0.001|TWO_SIDED|95.0|-13.45|-5.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-5.13|-13.45|<0.001
71673922|NCT00529373|142866205|OTHER||Mean Difference (Final Values)|-7.64|||<|0.001|TWO_SIDED|95.0|-11.87|-3.41|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-3.41|-11.87|<0.001
71673923|NCT00529373|142866205|OTHER||Mean Difference (Final Values)|-0.77||||0.896|TWO_SIDED|95.0|-12.34|10.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||10.79|-12.34|0.896
71673924|NCT00529373|142866206|OTHER||Mean Difference (Final Values)|-29.43|||<|0.001|TWO_SIDED|95.0|-33.47|-25.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-25.39|-33.47|<0.001
71673925|NCT00529373|142866206|OTHER||Mean Difference (Final Values)|-25.94|||<|0.001|TWO_SIDED|95.0|-30.54|-21.34|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-21.34|-30.54|<0.001
71796967|NCT05409235|143093013|SUPERIORITY||Mean Difference (Net)|-0.5325||||0.647|TWO_SIDED|90.0|-2.8478|1.7827|||ANCOVA|||||1.7827|-2.8478|0.647
71796968|NCT05409235|143093013|SUPERIORITY||Mean Difference (Net)|-2.2849||||0.945|TWO_SIDED|90.0|-4.6356|0.0658|||ANCOVA|||||0.0658|-4.6356|0.945
71796969|NCT05409235|143093014|SUPERIORITY||Odds Ratio (OR)|1.108||||0.367|TWO_SIDED|90.0|0.6722|1.8276|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.8276|0.6722|0.367
71673926|NCT00529373|142866206|OTHER||Mean Difference (Final Values)|-16.26|||<|0.001|TWO_SIDED|95.0|-21.41|-11.12|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-11.12|-21.41|<0.001
71673927|NCT00529373|142866206|OTHER||Mean Difference (Final Values)|-12.11|||<|0.001|TWO_SIDED|95.0|-18.03|-6.19|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||-6.19|-18.03|<0.001
71673928|NCT00529373|142866206|OTHER||Mean Difference (Final Values)|-3.34||||0.61|TWO_SIDED|95.0|-16.12|9.45|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).||9.45|-16.12|0.610
71673929|NCT00529373|142866207|OTHER||Hazard Ratio (HR)|1.12||||0.182|TWO_SIDED|95.0|0.95|1.34|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.34|0.95|0.182
71673930|NCT00529373|142866208|OTHER||Hazard Ratio (HR)|1.18||||0.235|TWO_SIDED|95.0|0.9|1.55|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.55|0.9|0.235
71673931|NCT00529373|142866209|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
71673932|NCT00529373|142866210|OTHER||Hazard Ratio (HR)|1.06||||0.857|TWO_SIDED|95.0|0.59|1.89|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.89|0.59|0.857
71673933|NCT00529373|142866211|OTHER||Hazard Ratio (HR)|1.1||||0.606|TWO_SIDED|95.0|0.76|1.59|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.59|0.76|0.606
71796970|NCT05409235|143093014|SUPERIORITY||Odds Ratio (OR)|0.717||||0.857|TWO_SIDED|90.0|0.4295|1.1981|||odds ratio|Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor||||1.1981|0.4295|0.857
71796971|NCT05409235|143093015|SUPERIORITY||Mean Difference (Net)|4.1531||||0.437|TWO_SIDED|90.0|-38.793|47.0991|||ANCOVA|||||47.0991|-38.7930|0.437
71796972|NCT05409235|143093015|SUPERIORITY||Mean Difference (Net)|-16.2461||||0.733|TWO_SIDED|90.0|-59.2538|26.7616|||ANCOVA|||||26.7616|-59.2538|0.733
71796973|NCT05409235|143093016|SUPERIORITY||Mean Difference (Net)|4.0634||||0.77|TWO_SIDED|90.0|-4.9712|13.098|||ANCOVA|||||13.0980|-4.9712|0.770
71796974|NCT05409235|143093016|SUPERIORITY||Mean Difference (Net)|-1.0507||||0.424|TWO_SIDED|90.0|-10.1046|8.0032|||ANCOVA|||||8.0032|-10.1046|0.424
71796975|NCT05409235|143093017|SUPERIORITY||Mean Difference (Net)|0.0205||||0.606|TWO_SIDED|90.0|-0.1043|0.1452|||ANCOVA|||||0.1452|-0.1043|0.606
71796976|NCT05409235|143093017|SUPERIORITY||Mean Difference (Net)|0.0083||||0.544|TWO_SIDED|90.0|-0.1161|0.1326|||ANCOVA|||||0.1326|-0.1161|0.544
71796977|NCT05409235|143093018|SUPERIORITY||difference in percentage of participants|-1.544||||0.406|TWO_SIDED|90.0|-12.247|9.158|||Mantel Haenszel|||||9.158|-12.247|0.406
71673934|NCT00529373|142866212|OTHER||Hazard Ratio (HR)|1.25||||0.074|TWO_SIDED|95.0|0.98|1.6|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.6|0.98|0.074
71796978|NCT05409235|143093018|SUPERIORITY||difference in percentage of participants|1.763||||0.605|TWO_SIDED|90.0|-9.114|12.64|||Mantel Haenszel|||||12.640|-9.114|0.605
71840415|NCT05698875|143190037|OTHER||Mean Difference (Final Values)|1.5||||0.08|TWO_SIDED|95.0|0.2|2.9||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs MGL meals||2.9|0.2|0.08
71673935|NCT00529373|142866213|OTHER||Hazard Ratio (HR)|1.12||||0.127|TWO_SIDED|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.29|0.97|0.127
71796979|NCT05409235|143093019|SUPERIORITY||Hazard Ratio (HR)|0.916||||0.404|TWO_SIDED|90.0|0.5068|1.6556|||Log Rank|||||1.6556|0.5068|0.404
71796980|NCT05409235|143093019|SUPERIORITY||Hazard Ratio (HR)|1.128||||0.624|TWO_SIDED|90.0|0.6399|1.9868|||Log Rank|||||1.9868|0.6399|0.624
71796981|NCT05409235|143093020|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.478|TWO_SIDED|90.0|0.2473|3.6295|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor.||||3.6295|0.2473|0.478
71796982|NCT05409235|143093020|SUPERIORITY||Hazard Ratio (HR)|1.296||||0.631|TWO_SIDED|90.0|0.3688|4.5512|||Log Rank|Comparisons are made using the log-rank test stratified by randomization stratification factor||||4.5512|0.3688|0.631
71796983|NCT05409235|143093021|SUPERIORITY||difference in percentage of participants|-13.7727||||0.045|TWO_SIDED|90.0|-27.1319|-0.4134|||Mantel Haenszel|||||-0.4134|-27.1319|0.0450
71796984|NCT05409235|143093021|SUPERIORITY||difference in percentage of participants|-3.8234||||0.3304|TWO_SIDED|90.0|-18.1549|10.5081|||Mantel Haenszel|||||10.5081|-18.1549|0.3304
71796985|NCT05409235|143093022|SUPERIORITY||difference in percentage of participants|-14.8877||||0.0275|TWO_SIDED|90.0|-27.6462|-2.1293|||Mantel Haenszel|||||-2.1293|-27.6462|0.0275
71796986|NCT05409235|143093022|SUPERIORITY||difference in percentage of participants|-7.5535||||0.179|TWO_SIDED|90.0|-21.0688|5.9617|||Mantel Haenszel|||||5.9617|-21.0688|0.1790
71796987|NCT00749931|143093034|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71796988|NCT00749931|143093035|SUPERIORITY_OR_OTHER||Relative reduction|0.47||||0.002|||||||Fisher Exact|||||||0.002
71796989|NCT01153581|143093038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71673936|NCT00529373|142866214|OTHER||Hazard Ratio (HR)|1.16||||0.277|TWO_SIDED|95.0|0.89|1.52|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.52|0.89|0.277
71796990|NCT00249470|143093047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.8||||0.004|TWO_SIDED|95.0|2.03|16.56|||General Estimating Equation (GEE)|||||16.56|2.03|.004
71796991|NCT00249470|143093048|SUPERIORITY||Odds Ratio (OR)|0.91|||=|0.82|TWO_SIDED|95.0|0.4|2.08|||General Estimating Equation (GEE)|||||2.08|0.40|=0.82
71796992|NCT00249470|143093049|SUPERIORITY||Odds Ratio (OR)|3.37||||0.04|TWO_SIDED|95.0|1.21|9.37|||General Estimating Equation (GEE)|||||9.37|1.21|0.04
71673937|NCT00529373|142866215|OTHER||Hazard Ratio (HR)|0.82||||0.256|TWO_SIDED|95.0|0.58|1.15|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.15|0.58|0.256
71673938|NCT00529373|142866216|OTHER||Hazard Ratio (HR)|0.86||||0.794|TWO_SIDED|95.0|0.29|2.57|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.57|0.29|0.794
71796993|NCT00244712|143093050|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 \[ABC/3TC minus TDF/FTC\] was -12% or greater.|difference in response percentage|0.39||||0.913||95.0|-6.63|7.4|||Cochran-Mantel-Haenszel||Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2|||7.40|-6.63|0.913
71796994|NCT00500370|143093064|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
71796995|NCT00500370|143093065|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||<0.0001
71796996|NCT00500370|143093066|SUPERIORITY_OR_OTHER|||||||0.6766||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.6766
71796997|NCT00500370|143093067|SUPERIORITY_OR_OTHER|||||||0.0393||95.0|||||Cochran-Mantel-Haenszel|||||||0.0393
71796998|NCT00500370|143093068|SUPERIORITY_OR_OTHER|||||||0.1808||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1808
71796999|NCT00500370|143093069|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
71797000|NCT00500370|143093070|SUPERIORITY_OR_OTHER|||||||0.6651||95.0|||||ANCOVA|||||||0.6651
71840416|NCT05698875|143190037|OTHER||Mean Difference (Final Values)|0.9||||0.21|TWO_SIDED|95.0|-0.5|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.5|0.21
71840417|NCT05698875|143190038|OTHER||Mean Difference (Final Values)|0.8||||0.31|TWO_SIDED|95.0|-0.7|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs control meals||2.2|-0.7|0.31
71797001|NCT00500370|143093071|SUPERIORITY_OR_OTHER|||||||0.1204||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.1204
71797002|NCT00500370|143093072|SUPERIORITY_OR_OTHER|||||||0.8479||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.8479
71797003|NCT00500370|143093073|SUPERIORITY_OR_OTHER|||||||0.2151||95.0|||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2151
71797004|NCT00500370|143093074|SUPERIORITY_OR_OTHER|||||||0.7619||95.0|||||ANCOVA|||||||0.7619
71797005|NCT00500370|143093075|SUPERIORITY_OR_OTHER|||||||0.8973||95.0|||||ANCOVA|||||||0.8973
71797006|NCT00500370|143093076|SUPERIORITY_OR_OTHER|||||||0.6507||95.0|||||Cochran-Mantel-Haenszel|||||||0.6507
71797007|NCT00500370|143093077|SUPERIORITY_OR_OTHER|||||||0.2593||95.0|||||Cochran-Mantel-Haenszel|||||||0.2593
71797008|NCT00500370|143093078|SUPERIORITY_OR_OTHER|||||||0.2919||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.2919
71673939|NCT00529373|142866217|OTHER||Hazard Ratio (HR)|1.32||||0.034|TWO_SIDED|95.0|1.02|1.7|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.7|1.02|0.034
71797009|NCT00500370|143093079|SUPERIORITY_OR_OTHER|||||||0.0293||95.0|||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)||||0.0293
71797010|NCT01920932|143093107|SUPERIORITY||Binomial proportions|31.25|||||TWO_SIDED|90.0||||The comparison of the complete rate between the first 32 evaluable participants and the historical control of HOD99 unfavorable risk patients was estimated by the binomial proportions test.||||In the historical control (HOD99) 17% of patients had CR at week 8. Sample size for this objective is calculated based on a binomial distribution to test H0: p=17% vs. Ha: p\>17%, where p is the true CR rate after 2 cycles of AEPA. 32 patients are needed to detect 20% increase of CR rate with 80% power and 5% type I error. If it shows efficacy, the response results will be reported, and the study will continue to enroll for a total of 77 patients to assess response and EFS.||||
71797011|NCT01920932|143093109|SUPERIORITY|||||||0.004|||||||Fisher Exact|||Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).||||0.004
71797012|NCT01920932|143093110|SUPERIORITY|||||||0.0008|||||||Log Rank|||The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.||||0.0008
71797013|NCT01920932|143093115|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
71797014|NCT01920932|143093115|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.002
71797015|NCT01920932|143093115|SUPERIORITY|||||||0.067|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.067
71797016|NCT01920932|143093115|SUPERIORITY|||||||0.115|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.115
71673940|NCT00529373|142866218|OTHER||Hazard Ratio (HR)|1.91||||0.081|TWO_SIDED|95.0|0.93|3.97|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||3.97|0.93|0.081
71797017|NCT01920932|143093115|SUPERIORITY|||||||0.455|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.455
71797018|NCT01920932|143093115|SUPERIORITY|||||||0.636|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Pain and Hurt-T4, completion of radiation (approximately 8 months)||||0.636
71797019|NCT01920932|143093115|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
71797020|NCT01920932|143093115|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
71797021|NCT01920932|143093115|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Nausea-T4, completion of radiation (approximately 8 months)||||0.006
71797022|NCT01920932|143093115|SUPERIORITY|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.099
71673941|NCT00529373|142866219|OTHER||Difference in Least Squares Means|1.47|||<|0.001|TWO_SIDED|95.0|0.92|2.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.01|0.92|<0.001
71797023|NCT01920932|143093115|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.050
71797024|NCT01920932|143093115|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Procedural Anxiety-T4, completion of radiation (approximately 8 months)||||0.520
71797025|NCT01920932|143093115|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.024
71797026|NCT01920932|143093115|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.011
71797027|NCT01920932|143093115|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Treatment Anxiety-T4, completion of radiation (approximately 8 months)||||0.009
71797028|NCT01920932|143093115|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
71797029|NCT01920932|143093115|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||<.001
71797030|NCT01920932|143093115|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Worry-T4, completion of radiation (approximately 8 months)||||0.035
71797031|NCT01920932|143093115|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.037
71797032|NCT01920932|143093115|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.043
71797033|NCT01920932|143093115|SUPERIORITY|||||||0.044|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Cognitive Problems-T4, completion of radiation (approximately 8 months)||||0.044
71797034|NCT01920932|143093115|SUPERIORITY|||||||0.091|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.091
71797035|NCT01920932|143093115|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.248
71797036|NCT01920932|143093115|SUPERIORITY|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Perceived Physical Appearance-T4, completion of radiation (approximately 8 months)||||0.069
71797037|NCT01920932|143093115|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.010
71797038|NCT01920932|143093115|SUPERIORITY|||||||0.292|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.292
71797039|NCT01920932|143093115|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.3.0 Communication-T4, completion of radiation (approximately 8 months)||||0.429
71797040|NCT01920932|143093116|SUPERIORITY|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)||||0.975
71797041|NCT01920932|143093116|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.032
71797042|NCT01920932|143093116|SUPERIORITY|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.497
71797043|NCT01920932|143093116|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)||||0.399
71797044|NCT01920932|143093116|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)||||0.451
71797045|NCT01920932|143093116|SUPERIORITY|||||||0.198|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.198
71797046|NCT01920932|143093116|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.967
71797047|NCT01920932|143093116|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)||||0.647
71797048|NCT01920932|143093116|SUPERIORITY|||||||0.145|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)||||0.145
71797049|NCT01920932|143093116|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||<.001
71797050|NCT01920932|143093116|SUPERIORITY|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.073
71797051|NCT01920932|143093116|SUPERIORITY|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)||||0.156
71797052|NCT01920932|143093116|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T1, At Diagnosis (baseline)||||0.844
71797053|NCT01920932|143093116|SUPERIORITY|||||||0.206|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.206
71797054|NCT01920932|143093116|SUPERIORITY|||||||0.491|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.491
71797055|NCT01920932|143093116|SUPERIORITY|||||||0.906|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 Social Functioning-T4, completion of radiation (approximately 8 months)||||0.906
71893337|NCT05224258|143307648|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|65.7||||0.208|TWO_SIDED|95.0|63.5|67.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||67.9|63.5|0.208
71797056|NCT01920932|143093116|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T1, At Diagnosis (baseline)||||0.580
71893338|NCT05224258|143307648|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.1|||<|0.001|TWO_SIDED|95.0|75.4|78.9|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||78.9|75.4|<0.001
71797057|NCT01920932|143093116|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)||||0.012
71797058|NCT01920932|143093116|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)||||0.010
71797059|NCT01920932|143093116|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||PedsQL v.4.0 School Functioning-T4, completion of radiation (approximately 8 months)||||0.005
71797060|NCT00071812|143093121|SUPERIORITY_OR_OTHER||percent difference from placebo|18.8||||0.0097|TWO_SIDED|95.0|4.8|32.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||32.8|4.8|0.0097
71797061|NCT00071812|143093121|SUPERIORITY_OR_OTHER||percent difference from placebo|9.4||||0.1677|TWO_SIDED|95.0|-3.9|22.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||22.7|-3.9|0.1677
71797062|NCT00071812|143093121|SUPERIORITY_OR_OTHER||percent difference from placebo|12.2||||0.0796|TWO_SIDED|95.0|-1.3|25.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||25.8|-1.3|0.0796
71797063|NCT00071812|143093122|SUPERIORITY_OR_OTHER||percent difference from placebo|5.4||||0.2074|TWO_SIDED|95.0|-3.0|13.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||13.7|-3.0|0.2074
71893339|NCT03375320|143307695|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
71797064|NCT00071812|143093122|SUPERIORITY_OR_OTHER||percent difference from placebo|4.1||||0.3177|TWO_SIDED|95.0|-4.0|12.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||12.2|-4.0|0.3177
71797065|NCT00071812|143093122|SUPERIORITY_OR_OTHER||percent difference from placebo|9.7||||0.0418|TWO_SIDED|95.0|0.3|19.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||19.2|0.3|0.0418
71797066|NCT00071812|143093123|SUPERIORITY_OR_OTHER||percent difference from placebo|2.7||||0.4299|TWO_SIDED|95.0|-4.0|9.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||9.3|-4.0|0.4299
71673942|NCT00529373|142866219|OTHER||Difference in Least Squares Means|2.21|||<|0.001|TWO_SIDED|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.37|2.05|<0.001
71673943|NCT00529373|142866219|OTHER||Difference in Least Squares Means|4.39|||<|0.001|TWO_SIDED|95.0|4.2|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.57|4.20|<0.001
71673944|NCT00529373|142866219|OTHER||Difference in Least Squares Means|6.5|||<|0.001|TWO_SIDED|95.0|6.28|6.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.72|6.28|<0.001
71797067|NCT00071812|143093123|SUPERIORITY_OR_OTHER||percent difference from placebo|-1.5||||0.5393|TWO_SIDED|95.0|-6.3|3.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||3.3|-6.3|0.5393
71797068|NCT00071812|143093123|SUPERIORITY_OR_OTHER||percent difference from placebo|-0.1||||0.9769|TWO_SIDED|95.0|-5.6|5.4||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.||5.4|-5.6|0.9769
71797069|NCT00071812|143093124|SUPERIORITY_OR_OTHER|||||||0.1752||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.1752
71797070|NCT00071812|143093124|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.3440
71797071|NCT00071812|143093124|SUPERIORITY_OR_OTHER|||||||0.4308||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.||||0.4308
71797072|NCT00071812|143093127|SUPERIORITY_OR_OTHER|||||||0.0958||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using last observation carried forward (LOCF) imputation.||||0.0958
71797073|NCT00071812|143093127|SUPERIORITY_OR_OTHER|||||||0.7864||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.7864
71797074|NCT00071812|143093127|SUPERIORITY_OR_OTHER|||||||0.0051||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.0051
71797075|NCT00071812|143093128|SUPERIORITY_OR_OTHER|||||||0.096||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0960
71797076|NCT00071812|143093128|SUPERIORITY_OR_OTHER|||||||0.2859||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.2859
71797077|NCT00071812|143093128|SUPERIORITY_OR_OTHER|||||||0.0109||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.||||0.0109
71797078|NCT00071812|143093129|SUPERIORITY_OR_OTHER|||||||0.194||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.1940
71797079|NCT00071812|143093129|SUPERIORITY_OR_OTHER|||||||0.2561||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.2561
71673945|NCT00529373|142866219|OTHER||Difference in Least Squares Means|8.29|||<|0.001|TWO_SIDED|95.0|8.02|8.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.57|8.02|<0.001
71673946|NCT00529373|142866219|OTHER||Difference in Least Squares Means|10.05|||<|0.001|TWO_SIDED|95.0|9.72|10.38|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.38|9.72|<0.001
71797080|NCT00071812|143093129|SUPERIORITY_OR_OTHER|||||||0.8707||95.0||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||||0.8707
71797081|NCT02633956|143093201|OTHER|Estimation|Least Square Mean Difference|13.79|STANDARD_ERROR_OF_MEAN|5.75|||TWO_SIDED|95.0|2.28|25.3||||||||25.30|2.28|
71797082|NCT02633956|143093201|OTHER|Estimation|Least Square Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|5.61|||TWO_SIDED|95.0|-2.18|20.3||||||||20.30|-2.18|
71893340|NCT03375320|143307695|SUPERIORITY||||||<|0.0001|||||||One-sided unstratified log-rank|||||||<0.0001
71840418|NCT05698875|143190038|OTHER||Mean Difference (Final Values)|-1.5||||0.05|TWO_SIDED|95.0|-3.0|-0.1||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGLP meals vs control meals||-0.1|-3.0|0.05
71840419|NCT05698875|143190038|OTHER||Mean Difference (Final Values)|0.03||||0.97|TWO_SIDED|95.0|-1.5|1.5||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||MGL meals vs control meals||1.5|-1.5|0.97
71840420|NCT05698875|143190038|OTHER||Mean Difference (Final Values)|2.3|||<|0.01|TWO_SIDED|95.0|1.0|3.6||a priori threshold for statistical significance p\<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||3.6|1.0|<0.01
71840421|NCT05698875|143190038|OTHER||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED|95.0|0.6|2.2||a priori threshold for statistical significance p\<0.05|Linear Mixed Model|||HGL meals vs MGL meals||2.2|0.6|0.27
71893341|NCT03375320|143307696|SUPERIORITY|||||||0.2438|||||||One-sided stratified log-rank|||||||0.2438
71797083|NCT02633956|143093201|OTHER|Estimation|Least Square Mean Difference|20.13|STANDARD_ERROR_OF_MEAN|6.39|||TWO_SIDED|95.0|7.33|32.92||||||||32.92|7.33|
71797084|NCT02633956|143093202|OTHER|Estimation|Least Square Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|0.07|0.75||||||||0.75|0.07|
71797085|NCT02633956|143093202|OTHER|Estimation|Least Square Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.25|0.42||||||||0.42|-0.25|
71797086|NCT02633956|143093202|OTHER|Estimation|Least Square Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|0.14|0.89||||||||0.89|0.14|
71797087|NCT02633956|143093203|OTHER|Estimation|Least Square Mean Difference|103.61|STANDARD_ERROR_OF_MEAN|69.51|||TWO_SIDED|95.0|-35.58|242.81||||||||242.81|-35.58|
71797088|NCT02633956|143093203|OTHER|Estimation|Least Square Mean Difference|114.8|STANDARD_ERROR_OF_MEAN|68.08|||TWO_SIDED|95.0|-21.53|251.13||||||||251.13|-21.53|
71797089|NCT02633956|143093203|OTHER|Estimation|Least Square Mean Difference|215.05|STANDARD_ERROR_OF_MEAN|79.51|||TWO_SIDED|95.0|55.84|374.26||||||||374.26|55.84|
71840422|NCT05698875|143190038|OTHER||Mean Difference (Final Values)|1.5||||0.12|TWO_SIDED|95.0|0.1|3.0||a priori threshold for statistical significance \<0.05 Adjusted with p value|Linear Mixed Model|||MGL meals vs HGLP meals||3.0|0.1|0.12
71840423|NCT05698875|143190039|OTHER||Mean Difference (Final Values)|-0.2||||0.83|TWO_SIDED|95.0|-1.5|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.2|-1.5|0.83
71840424|NCT05698875|143190039|OTHER||Mean Difference (Final Values)|-1.5||||0.09|TWO_SIDED|95.0|-2.9|-0.2||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGLP meals vs control meals||-0.2|-2.9|0.09
71893342|NCT03375320|143307696|SUPERIORITY|||||||0.4426|||||||One-sided stratified log-rank|||||||0.4426
71893343|NCT03375320|143307698|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71893344|NCT03375320|143307698|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71893345|NCT01128387|143307699|OTHER||Maximum Tolerated Dose|1.5|||||TWO_SIDED|||||||||Dose of Pantiumumab (in combination with Cisplatin \& Fluorouracil - see below)||||
71893346|NCT01128387|143307699|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||Dose of Cisplatin||||
71797090|NCT01166594|143093204|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71840425|NCT05698875|143190039|OTHER||Mean Difference (Final Values)|-0.2||||0.78|TWO_SIDED|95.0|-1.6|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.6|0.78
71840426|NCT05698875|143190039|OTHER||Mean Difference (Final Values)|1.4||||0.11|TWO_SIDED|95.0|0.1|2.7||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.7|0.1|0.11
71840427|NCT05698875|143190039|OTHER||Mean Difference (Final Values)|-0.2||||0.82|TWO_SIDED|95.0|-1.5|1.1||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGL meals||1.1|-1.5|0.82
71840428|NCT05698875|143190039|OTHER||Mean Difference (Final Values)|1.3||||0.06|TWO_SIDED|95.0|-0.1|2.6||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.6|-0.1|0.06
71840429|NCT05698875|143190040|OTHER||Mean Difference (Final Values)|0.1||||0.85|TWO_SIDED|95.0|-1.1|1.3||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs control meals||1.3|-1.1|0.85
71893347|NCT01128387|143307699|OTHER||Maximum Tolerated Dose|750.0|||||TWO_SIDED|||||||||Dose of Fluorourcil||||
71893348|NCT01535235|143307701|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71893349|NCT01535235|143307702|SUPERIORITY_OR_OTHER|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71797091|NCT01993108|143093219|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||.02
71797092|NCT01993108|143093219|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.118|TWO_SIDED||||||t-test, 2 sided|||||||.118
71797093|NCT01993108|143093219|SUPERIORITY||Median Difference (Final Values)|0.02||||0.349|TWO_SIDED||||||t-test, 2 sided|||||||.349
71797094|NCT01993108|143093219|SUPERIORITY||Median Difference (Final Values)|0.02||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
71797095|NCT01993108|143093220|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||.019
71797096|NCT01993108|143093220|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||.240
71797097|NCT01993108|143093220|SUPERIORITY||Median Difference (Final Values)|0.06||||0.081|TWO_SIDED||||||t-test, 2 sided|||||||.081
71840430|NCT05698875|143190040|OTHER||Mean Difference (Final Values)|-1.2||||0.06|TWO_SIDED|95.0|-2.4|0.04||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGLP meals vs control meals||0.04|-2.4|0.06
71840431|NCT05698875|143190040|OTHER||Mean Difference (Final Values)|-0.08||||0.9|TWO_SIDED|95.0|-1.3|1.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs control meals||1.2|-1.3|0.90
71893350|NCT03352245|143307736|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.889|TWO_SIDED||||||Mixed Models Analysis|||||||0.889
71893351|NCT03352245|143307737|SUPERIORITY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.88||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
71893352|NCT03352245|143307738|SUPERIORITY||Mean Difference (Net)|7.79|STANDARD_ERROR_OF_MEAN|5.51||0.166|TWO_SIDED||||||Mixed Models Analysis|||||||0.166
71893353|NCT03352245|143307739|SUPERIORITY||Mean Difference (Net)|-0.64|STANDARD_ERROR_OF_MEAN|3.41||0.853|TWO_SIDED||||||Mixed Models Analysis|||||||0.853
71893354|NCT03352245|143307740|SUPERIORITY||Mean Difference (Net)|17.04|STANDARD_ERROR_OF_MEAN|7.16||0.022|TWO_SIDED||||||Mixed Models Analysis|||||||0.022
71673947|NCT00529373|142866220|OTHER||Difference in Least Squares Means|1.1|||<|0.001|TWO_SIDED|95.0|0.66|1.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.54|0.66|<0.001
71673948|NCT00529373|142866220|OTHER||Difference in Least Squares Means|1.36|||<|0.001|TWO_SIDED|95.0|0.87|1.85|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.85|0.87|<0.001
71673949|NCT00529373|142866220|OTHER||Difference in Least Squares Means|1.96|||<|0.001|TWO_SIDED|95.0|1.42|2.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.50|1.42|<0.001
71673950|NCT00529373|142866220|OTHER||Difference in Least Squares Means|2.18|||<|0.001|TWO_SIDED|95.0|1.4|2.96|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.96|1.40|<0.001
71673951|NCT00529373|142866220|OTHER||Difference in Least Squares Means|2.33||||0.001|TWO_SIDED|95.0|1.54|3.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.11|1.54|0.001
71797098|NCT01993108|143093220|SUPERIORITY||Median Difference (Final Values)|0.04||||0.247|TWO_SIDED||||||t-test, 2 sided|||||||.247
71797099|NCT01993108|143093221|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.049|TWO_SIDED||||||t-test, 2 sided|||||||.049
71673952|NCT00529373|142866221|OTHER||Hazard Ratio (HR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.45|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. the Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.45|0.24|<0.001
71673953|NCT00529373|142866222|OTHER||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.6|0.75|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.||0.75|0.60|<0.001
71797100|NCT01993108|143093221|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.497|TWO_SIDED||||||t-test, 2 sided|||||||.497
71797101|NCT01993108|143093221|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.814|TWO_SIDED||||||t-test, 2 sided|||||||.814
71673954|NCT00529373|142866223|OTHER||Difference in Least Squares Means|1.34|||<|0.001|TWO_SIDED|95.0|0.94|1.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||1.74|0.94|<0.001
71797102|NCT01993108|143093221|SUPERIORITY||Mean Difference (Net)|0.01||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||.593
71797103|NCT01993108|143093222|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.926|TWO_SIDED||||||t-test, 2 sided|||||||.926
71797104|NCT01993108|143093222|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.126|TWO_SIDED||||||t-test, 2 sided|||||||.126
71673955|NCT00529373|142866223|OTHER||Difference in Least Squares Means|2.5|||<|0.001|TWO_SIDED|95.0|2.38|2.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.62|2.38|<0.001
71673956|NCT00529373|142866223|OTHER||Difference in Least Squares Means|4.47|||<|0.001|TWO_SIDED|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.62|4.31|<0.001
71673957|NCT00529373|142866223|OTHER||Difference in Least Squares Means|6.46|||<|0.001|TWO_SIDED|95.0|6.26|6.65|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.65|6.26|<0.001
71673958|NCT00529373|142866223|OTHER||Difference in Least Squares Means|8.48|||<|0.001|TWO_SIDED|95.0|8.24|8.73|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||8.73|8.24|<0.001
71797105|NCT01993108|143093222|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.852|TWO_SIDED||||||t-test, 2 sided|||||||.852
71797106|NCT01993108|143093222|SUPERIORITY||Median Difference (Final Values)|0.11||||0.552|TWO_SIDED||||||t-test, 2 sided|||||||.552
71797107|NCT01802775|143093224|OTHER||Treatment Difference|-3.9|||||TWO_SIDED|95.0|-17.3|9.5||||||Treatment difference was edoxaban - clopidogrel. For the treatment difference, 95% Confidence interval was calculated using a normal approximation to the binomial distribution.||9.5|-17.3|
71797108|NCT00386256|143093229|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
71797109|NCT00386256|143093230|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.||||<.05
71797110|NCT03064126|143093235|SUPERIORITY||Risk Difference (RD)|0.166||||0.0017|ONE_SIDED|97.5|0.0553||||Chi-squared||||||0.0553|0.0017
71797111|NCT03064126|143093236|NON_INFERIORITY|A Chi-Square Test was used to assess the hypothesis for the difference in 12-month MAE-free rate with non-inferiority margin (-10%).|Risk Difference (RD)|0.106|||<|0.0001|ONE_SIDED|97.5|0.0248||||Chi-squared||||||0.0248|<0.0001
71797112|NCT02775344|143093287|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.198|TWO_SIDED||||||Chi-squared, Corrected|||||||0.198
71797113|NCT02775344|143093288|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.393|TWO_SIDED||||||Chi-squared, Corrected|||||||0.393
71673959|NCT00529373|142866223|OTHER||Difference in Least Squares Means|10.29|||<|0.001|TWO_SIDED|95.0|9.99|10.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||10.59|9.99|<0.001
71673960|NCT00529373|142866224|OTHER||Difference in Least Squares Means|1.74|||<|0.001|TWO_SIDED|95.0|1.06|2.42|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||2.42|1.06|<0.001
71673961|NCT00529373|142866224|OTHER||Difference in Least Squares Means|3.5|||<|0.001|TWO_SIDED|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.70|3.31|<0.001
71673962|NCT00529373|142866224|OTHER||Difference in Least Squares Means|6.41|||<|0.001|TWO_SIDED|95.0|6.16|6.65|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 24||6.65|6.16|<0.001
71673963|NCT00529373|142866224|OTHER||Difference in Least Squares Means|9.25|||<|0.001|TWO_SIDED|95.0|8.95|9.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.54|8.95|<0.001
71673964|NCT00529373|142866224|OTHER||Difference in Least Squares Means|12.14|||<|0.001|TWO_SIDED|95.0|11.76|12.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||12.51|11.76|<0.001
71673965|NCT00529373|142866224|OTHER||Difference in Least Squares Means|14.56|||<|0.001|TWO_SIDED|95.0|14.11|15.01|||Longitudinal model|Includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size)||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||15.01|14.11|<0.001
71673966|NCT00529373|142866225|OTHER||Difference in Least Squares Means|2.9|||<|0.001|TWO_SIDED|95.0|2.4|3.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||3.39|2.40|<0.001
71673967|NCT00529373|142866225|OTHER||Difference in Least Squares Means|4.01|||<|0.001|TWO_SIDED|95.0|3.87|4.15|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||4.15|3.87|<0.001
71797114|NCT04609020|143093303|SUPERIORITY||Mean Difference (Final Values)|46.6|STANDARD_DEVIATION|23.61|<|0.0001|ONE_SIDED|97.5|40.58|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||40.58|<0.0001
71673968|NCT00529373|142866225|OTHER||Difference in Least Squares Means|5.93|||<|0.001|TWO_SIDED|95.0|5.75|6.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||6.11|5.75|<0.001
71673969|NCT00529373|142866225|OTHER||Difference in Least Squares Means|7.7|||<|0.001|TWO_SIDED|95.0|7.48|7.91|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||7.91|7.48|<0.001
71673970|NCT00529373|142866225|OTHER||Difference in Least Squares Means|9.34|||<|0.001|TWO_SIDED|95.0|9.08|9.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||9.61|9.08|<0.001
71673971|NCT00529373|142866225|OTHER||Difference in Least Squares Means|10.87|||<|0.001|TWO_SIDED|95.0|10.55|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region \& interaction between treatment \& time as fixed effects (LS means weighted for region \& stratum size).||11.19|10.55|<0.001
71673972|NCT00529373|142866234|OTHER||Difference in Least Squares Means|2.76|||<|0.001|TWO_SIDED|95.0|1.43|4.1|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.10|1.43|<0.001
71673973|NCT00529373|142866235|OTHER||Difference in Least Squares Means|5.55|||<|0.001|TWO_SIDED|95.0|4.06|7.05|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.05|4.06|<0.001
71673974|NCT00529373|142866236|OTHER||Difference in Least Squares Means|2.79||||0.005|TWO_SIDED|95.0|0.86|4.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.72|0.86|0.005
71673975|NCT00529373|142866237|OTHER||Difference in Least Squares Means|3.63|||<|0.001|TWO_SIDED|95.0|2.35|4.9|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||4.90|2.35|<0.001
71797115|NCT04609020|143093304|SUPERIORITY||Mean Difference (Final Values)|35.3|STANDARD_DEVIATION|22.36|<|0.0001|ONE_SIDED|97.5|29.61|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||29.61|<0.0001
71797116|NCT04609020|143093305|SUPERIORITY||Mean Difference (Final Values)|27.6|STANDARD_DEVIATION|23.23|<|0.0001|ONE_SIDED|97.5|21.5|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||21.50|<0.0001
71673976|NCT00529373|142866238|OTHER||Difference in Least Squares Means|5.65|||<|0.001|TWO_SIDED|95.0|3.79|7.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||7.50|3.79|<0.001
71893355|NCT03352245|143307741|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|3.83||0.911|TWO_SIDED||||||Mixed Models Analysis|||||||0.911
71673977|NCT00529373|142866239|OTHER||Difference in Least Squares Means|-62.25|||<|0.001|TWO_SIDED|95.0|-79.99|-44.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-44.50|-79.99|<0.001
71673978|NCT00529373|142866240|OTHER||Difference in Least Squares Means|-26.7||||0.001|TWO_SIDED|95.0|-42.56|-10.83|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-10.83|-42.56|0.001
71893356|NCT03352245|143307742|SUPERIORITY||Mean Difference (Net)|-5.18|STANDARD_ERROR_OF_MEAN|6.88||0.456|TWO_SIDED||||||Mixed Models Analysis|||||||0.456
71893357|NCT03352245|143307743|SUPERIORITY||Mean Difference (Net)|-2.05|STANDARD_ERROR_OF_MEAN|3.13||0.515|TWO_SIDED||||||Mixed Models Analysis|||||||0.515
71893358|NCT03352245|143307744|SUPERIORITY||Mean Difference (Net)|-8.65|STANDARD_ERROR_OF_MEAN|5.8||0.144|TWO_SIDED||||||Mixed Models Analysis|||||||0.144
71893359|NCT03352245|143307745|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|6.28||0.948|TWO_SIDED||||||Mixed Models Analysis|||||||0.948
71893360|NCT03352245|143307746|SUPERIORITY||Mean Difference (Net)|-8.62|STANDARD_ERROR_OF_MEAN|7.45||0.254|TWO_SIDED||||||Mixed Models Analysis|||||||0.254
71893361|NCT03352245|143307747|SUPERIORITY||Mean Difference (Net)|-13.31|STANDARD_ERROR_OF_MEAN|6.62||0.051|TWO_SIDED||||||Mixed Models Analysis|||||||0.051
71673979|NCT00529373|142866241|OTHER||Difference in Least Squares Means|1.67||||0.016|TWO_SIDED|95.0|0.32|3.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||3.01|0.32|0.016
71797117|NCT04609020|143093306|SUPERIORITY||Mean Difference (Final Values)|22.9|STANDARD_DEVIATION|20.56|<|0.0001|ONE_SIDED|97.5|17.65|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||17.65|<0.0001
71797118|NCT04609020|143093307|SUPERIORITY||Mean Difference (Final Values)|43.1|STANDARD_DEVIATION|22.25|<|0.0001|ONE_SIDED|97.5|37.48|||P-value is calculated based on 1-sided t-test or Wilcoxon signed-rank test (if the normality assumption is not met) at 0.025 significance level.|t-test, 1 sided||||||37.48|<0.0001
71797119|NCT02107599|143093325|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Asymptotic Z-test|||||||0.0001
71797120|NCT02107599|143093326|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0060
71797121|NCT02107599|143093326|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.1229
71797122|NCT02107599|143093326|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.||||0.0260
71797123|NCT01479621|143093356|SUPERIORITY_OR_OTHER|||||||0.0001||||||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed followed by pairwise comparisons of each Fp MDPI dose versus placebo.||||0.0001
71797124|NCT01479621|143093356|SUPERIORITY_OR_OTHER||LSM difference|0.149||||0.0005|TWO_SIDED|95.0|0.066|0.233||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|mixed model for repeated measures|||This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.233|0.066|0.0005
71797125|NCT01479621|143093356|SUPERIORITY_OR_OTHER||LSM difference|0.126||||0.0027|TWO_SIDED|95.0|0.044|0.208|||mixed model for repeated measures|||This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.208|0.044|0.0027
71797126|NCT01479621|143093356|SUPERIORITY_OR_OTHER||LSM difference|0.111||||0.0086|TWO_SIDED|95.0|0.028|0.194|||mixed model for repeated measures|||This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.194|0.028|0.0086
71797127|NCT01479621|143093356|SUPERIORITY_OR_OTHER||LSM difference|0.052||||0.2227|TWO_SIDED|95.0|-0.032|0.136|||mixed model for repeated measures|||This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.||0.136|-0.032|0.2227
71797128|NCT01479621|143093357|SUPERIORITY_OR_OTHER|||||||0.0017||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0017
71797129|NCT01479621|143093357|SUPERIORITY_OR_OTHER||LSM difference|18.29||||0.006|TWO_SIDED|95.0|5.28|31.29||Significance at 0.05|mixed model for repeated measures|||||31.29|5.28|0.0060
71797130|NCT01479621|143093357|SUPERIORITY_OR_OTHER||LSM difference|20.32||||0.0018|TWO_SIDED|95.0|7.61|33.03||Significance at 0.05|mixed model for repeated measures|||||33.03|7.61|0.0018
71797131|NCT01479621|143093357|SUPERIORITY_OR_OTHER||LSM difference|11.75||||0.0741|TWO_SIDED|95.0|-1.15|24.64||Significance at 0.05|mixed model for repeated measures|||||24.64|-1.15|0.0741
71797132|NCT01479621|143093357|SUPERIORITY_OR_OTHER||LSM difference|21.72||||0.0011|TWO_SIDED|95.0|8.73|34.72||Significance at 0.05|mixed model for repeated measures|||||34.72|8.73|0.0011
71797133|NCT01479621|143093358|SUPERIORITY_OR_OTHER|||||||0.0434||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).||||0.0434
71797134|NCT01479621|143093358|SUPERIORITY_OR_OTHER||LSM difference|11.06||||0.0852|TWO_SIDED|95.0|-1.54|23.66||Significance at 0.05|mixed model for repeated measures|||||23.66|-1.54|0.0852
71893362|NCT03352245|143307748|SUPERIORITY||Mean Difference (Net)|4.07|STANDARD_ERROR_OF_MEAN|8.71||0.643|TWO_SIDED||||||Mixed Models Analysis|||||||0.643
71673980|NCT00529373|142866242|OTHER||Difference in Least Squares Means|-25.02|||<|0.001|TWO_SIDED|95.0|-35.92|-14.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-14.12|-35.92|<0.001
71797135|NCT01479621|143093358|SUPERIORITY_OR_OTHER||LSM difference|12.78||||0.0411|TWO_SIDED|95.0|0.52|25.04||Significance at 0.05|mixed model for repeated measures|||||25.04|0.52|0.0411
71797136|NCT01479621|143093358|SUPERIORITY_OR_OTHER||LSM difference|9.28||||0.1428|TWO_SIDED|95.0|-3.14|21.69||Significance at 0.05|mixed model for repeated measures|||||21.69|-3.14|0.1428
71797137|NCT01479621|143093358|SUPERIORITY_OR_OTHER||LSM difference|18.23||||0.0046|TWO_SIDED|95.0|5.64|30.82||Significance at 0.05|mixed model for repeated measures|||||30.82|5.64|0.0046
71797138|NCT01479621|143093359|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|2.76||||0.66685|TWO_SIDED|95.0|-10.07|15.6|||GEE|The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||15.60|-10.07|0.66685
71797139|NCT01479621|143093359|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|6.76||||0.26741|TWO_SIDED|95.0|-5.43|18.94||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||18.94|-5.43|0.26741
71797140|NCT01479621|143093359|SUPERIORITY_OR_OTHER||estimated mean difference from placebo|10.45||||0.09964|TWO_SIDED|95.0|-2.24|23.15||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||23.15|-2.24|0.09964
71797141|NCT01479621|143093359|SUPERIORITY_OR_OTHER||Slope|12.78||||0.03825|TWO_SIDED|95.0|0.44|25.11||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.||25.11|0.44|0.03825
71797142|NCT01479621|143093360|SUPERIORITY_OR_OTHER|||||||0.2841||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.2841
71797143|NCT01479621|143093360|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||<0.0001
71797144|NCT01479621|143093360|SUPERIORITY_OR_OTHER|||||||0.0008||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0008
71797145|NCT01479621|143093360|SUPERIORITY_OR_OTHER|||||||0.001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo||||0.0010
71797146|NCT01479621|143093366|SUPERIORITY_OR_OTHER||LSM difference|-0.114||||0.0058|TWO_SIDED|95.0|-0.195|-0.033||Significance at 0.05|mixed model for repeated measures|||||-0.033|-0.195|0.0058
71797147|NCT01479621|143093366|SUPERIORITY_OR_OTHER||LSM difference|0.034||||0.4083|TWO_SIDED|95.0|-0.046|0.114||Significance at 0.05|mixed model for repeated measures|||||0.114|-0.046|0.4083
71673981|NCT00529373|142866243|OTHER||Difference in Least Squares Means|-64.43|||<|0.001|TWO_SIDED|95.0|-87.8|-41.07|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||-41.07|-87.80|<0.001
71797148|NCT01479621|143093366|SUPERIORITY_OR_OTHER||LSM difference|0.011||||0.7882|TWO_SIDED|95.0|-0.068|0.089||Significance at 0.05|mixed model for repeated measures|||||0.089|-0.068|0.7882
71797149|NCT01479621|143093366|SUPERIORITY_OR_OTHER||LSM difference|-0.002||||0.9586|TWO_SIDED|95.0|-0.082|0.078||Significance at 0.05|mixed model for repeated measures|||||0.078|-0.082|0.9586
71797150|NCT01479621|143093366|SUPERIORITY_OR_OTHER||LSM difference|-0.062||||0.1306|TWO_SIDED|95.0|-0.143|0.018||Significance at 0.05|mixed model for repeated measures|||||0.018|-0.143|0.1306
71797151|NCT01479621|143093367|SUPERIORITY_OR_OTHER||LSM difference|-17.66||||0.0068|TWO_SIDED|95.0|-30.43|-4.89||Significance at 0.05|mixed model for repeated measures|||||-4.89|-30.43|0.0068
71797152|NCT01479621|143093367|SUPERIORITY_OR_OTHER||LSM difference|0.69||||0.9135|TWO_SIDED|95.0|-11.84|13.23||Significance at 0.05|mixed model for repeated measures|||||13.23|-11.84|0.9135
71797153|NCT01479621|143093367|SUPERIORITY_OR_OTHER||LSM difference|2.67||||0.6689|TWO_SIDED|95.0|-9.58|14.92||Significance at 0.05|mixed model for repeated measures|||||14.92|-9.58|0.6689
71797154|NCT01479621|143093367|SUPERIORITY_OR_OTHER||LSM difference|-5.69||||0.3691|TWO_SIDED|95.0|-18.12|6.74||Significance at 0.05|mixed model for repeated measures|||||6.74|-18.12|0.3691
71797155|NCT01479621|143093367|SUPERIORITY_OR_OTHER||LSM difference|4.24||||0.5072|TWO_SIDED|95.0|-8.31|16.78||Significance at 0.05|mixed model for repeated measures|||||16.78|-8.31|0.5072
71797156|NCT01479621|143093368|SUPERIORITY_OR_OTHER||LSM difference|-15.26||||0.0158|TWO_SIDED|95.0|-27.63|-2.88||Significance at 0.05|mixed model for repeated measures|||||-2.88|-27.63|0.0158
71797157|NCT01479621|143093368|SUPERIORITY_OR_OTHER||LSM difference|-4.48||||0.4709|TWO_SIDED|95.0|-16.69|7.721||Significance at 0.05|mixed model for repeated measures|||||7.721|-16.69|0.4709
71797158|NCT01479621|143093368|SUPERIORITY_OR_OTHER||LSM difference|-2.68||||0.6572|TWO_SIDED|95.0|-14.55|9.19||Significance at 0.05|mixed model for repeated measures|||||9.19|-14.55|0.6572
71797159|NCT01479621|143093368|SUPERIORITY_OR_OTHER||LSM difference|-5.98||||0.3292|TWO_SIDED|95.0|-18.01|6.05||Significance at 0.05|mixed model for repeated measures|||||6.05|-18.01|0.3292
71797160|NCT01479621|143093368|SUPERIORITY_OR_OTHER||LSM difference|3.05||||0.6237|TWO_SIDED|95.0|-9.16|15.26||Significance at 0.05|mixed model for repeated measures|||||15.26|-9.16|0.6237
71797161|NCT01417481|143093399|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
71673982|NCT00529373|142866244|OTHER||Difference in Least Squares Means|8.53|||<|0.001|TWO_SIDED|95.0|5.79|11.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||11.28|5.79|<0.001
71893363|NCT03352245|143307749|SUPERIORITY||Mean Difference (Net)|-9.11|STANDARD_ERROR_OF_MEAN|8.5||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.290
71797162|NCT01417481|143093400|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
71797163|NCT01417481|143093401|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||>0.05
71797164|NCT01417481|143093402|SUPERIORITY_OR_OTHER||||||=|0.061|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.061
71797165|NCT01417481|143093403|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.068
71797166|NCT01417481|143093404|SUPERIORITY_OR_OTHER||||||=|0.04|TWO_SIDED||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.||||||=0.040
71797167|NCT01417481|143093405|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.05
71797168|NCT01417481|143093406|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, paired analysis was done. The hypothesis was that glycine will improve variables, thus significance was set at one-tail.||||||<0.05
71797169|NCT01417481|143093407|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||<0.01
71797170|NCT01417481|143093408|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.||||||>0.05
71797171|NCT04296396|143093414|NON_INFERIORITY|A non-inferiority design assumed a noninferiority margin of 5%. For 90% power and 0.025 significance level 1-sided, a total sample size of 4,300 participants was required to state that the IOPP is not inferior to the fixed amount of 20 tablets. Given the short window to assess pain at 1-week post-discharge, a 20% missing rate was incorporated which gives a final sample size of 5,500 (2,750 per group).|Risk Difference (RD)|0.67|||||TWO_SIDED|95.0|-2.03|3.37|||||The risk difference is the rate in the fixed group minus the rate in the IOPP group. IOPP was to be determined as non-inferior if the lower 95% confidence limit for the risk difference is -5 percentage points or greater (i.e., closer to zero).|||3.37|-2.03|
71797172|NCT04296396|143093415|SUPERIORITY||Risk Ratio (RR)|1.22||||0.046|TWO_SIDED|96.25|0.99|1.51|||Chi-squared||Confidence interval is 96.25% due to false discovery rate adjustment|||1.51|0.99|0.046
71797173|NCT04296396|143093416|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71797174|NCT04296396|143093417|SUPERIORITY||Median Difference (Net)|-5.0|||<|0.001|TWO_SIDED|97.5|-6.6|-3.5|||quantile regression||Confidence interval is 97.5% due to false discovery rate adjustment|||-3.5|-6.6|<0.001
71797175|NCT04296396|143093418|SUPERIORITY||Median Difference (Net)|-15.0|||<|0.001|TWO_SIDED|98.75|-19.2|-10.8|||quartile regression||Confidence interval is 98.75% due to false discovery rate adjustment|||-10.8|-19.2|<0.001
71797176|NCT04296396|143093419|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|0.0|0.0|||quantile regression|||||0|0|1.0
71797177|NCT04296396|143093420|SUPERIORITY||Risk Ratio (RR)|0.96||||0.52|TWO_SIDED|95.0|0.85|1.09|||Chi-squared|||||1.09|0.85|0.52
71797178|NCT04296396|143093421|SUPERIORITY||Risk Ratio (RR)|0.99||||0.15|TWO_SIDED|95.0|0.98|1.0|||Regression, Linear|||||1.00|0.98|0.15
71797179|NCT02281552|143093429|NON_INFERIORITY|Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD - IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.|Least Square (LS) mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.17|0.69||||||Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.||0.69|0.17|
71797180|NCT01282424|143093473|SUPERIORITY||||||<|0.0001||||||The null hypothesis is ≤ 20%.|Exact binomial test|||||||< 0.0001
71797181|NCT04976530|143093501|SUPERIORITY||win ratio|1.07||||0.748|TWO_SIDED|95.0|0.72|1.58|||Finkelstein Schoenfeld test|||||1.58|0.72|0.748
71797182|NCT04976530|143093502|SUPERIORITY||win ratio|1.33||||0.202|TWO_SIDED|95.0|0.86|2.04|||Finkelstein Schoenfeld test|||||2.04|0.86|0.202
71797183|NCT04976530|143093503|SUPERIORITY||win ratio|1.17||||0.451|TWO_SIDED|95.0|0.79|1.73|||Finkelstein Schoenfeld test|||||1.73|0.79|0.451
71797184|NCT04976530|143093504|SUPERIORITY||win ratio|1.59||||0.041|TWO_SIDED|95.0|1.02|2.46|||Finkelstein Schoenfeld test|||||2.46|1.02|0.041
71797185|NCT04976530|143093505|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71797186|NCT04976530|143093506|SUPERIORITY|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||||||0.079
71797187|NCT04976530|143093507|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
71797188|NCT04976530|143093508|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
71797189|NCT03750903|143093513|OTHER|||||||0.05|||||||ANOVA|||||||0.05
71797190|NCT02643251|143093621|SUPERIORITY|||||||0.3361|||||||Mixed Models Analysis|||||||0.3361
71797191|NCT02365636|143093623|SUPERIORITY||LSM difference from placebo|0.32||||0.13|TWO_SIDED|95.0|-0.094|0.726||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.726|-0.094|0.130
71797192|NCT02365636|143093623|SUPERIORITY||LSM difference from placebo|0.24||||0.245|TWO_SIDED|95.0|-0.167|0.652||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.||0.652|-0.167|0.245
71893364|NCT03352245|143307750|SUPERIORITY||Mean Difference (Net)|9.99|STANDARD_ERROR_OF_MEAN|5.49||0.077|TWO_SIDED||||||Mixed Models Analysis|||||||0.077
71797193|NCT02365636|143093624|SUPERIORITY||LSM difference from placebo|0.32||||0.128|TWO_SIDED|95.0|-0.093|0.735||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.735|-0.093|0.128
71797194|NCT02365636|143093624|SUPERIORITY||LSM difference from placebo|0.27||||0.194|TWO_SIDED|95.0|-0.14|0.688||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.688|-0.140|0.194
71797195|NCT02365636|143093625|SUPERIORITY||LSM difference from placebo|0.28||||0.177|TWO_SIDED|95.0|-0.128|0.691||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.691|-0.128|0.177
71797196|NCT02365636|143093625|SUPERIORITY||LSM difference from placebo|0.2||||0.325|TWO_SIDED|95.0|-0.204|0.614||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.||0.614|-0.204|0.325
71797197|NCT02365636|143093626|SUPERIORITY||LSM difference from placebo|0.29||||0.202|TWO_SIDED|95.0|-0.158|0.741||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.741|-0.158|0.202
71797198|NCT02365636|143093626|SUPERIORITY||LSM difference from placebo|0.457||||0.457|TWO_SIDED|95.0|-0.28|0.621||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.||0.621|-0.280|0.457
71797199|NCT02365636|143093627|SUPERIORITY||Odds Ratio (OR)|0.92||||0.815|TWO_SIDED|95.0|0.456|1.856||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.856|0.456|0.815
71797200|NCT02365636|143093627|SUPERIORITY||Odds Ratio (OR)|1.05||||0.893|TWO_SIDED|95.0|0.52|2.117||5% level of significance|Regression, Logistic|||\>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.117|0.520|0.893
71797201|NCT02365636|143093627|SUPERIORITY||Odds Ratio (OR)|0.74||||0.43|TWO_SIDED|95.0|0.357|1.55||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||1.550|0.357|0.430
71797202|NCT02365636|143093627|SUPERIORITY||Odds Ratio (OR)|1.02||||0.967|TWO_SIDED|95.0|0.494|2.088||5% level of significance|Regression, Logistic|||\>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.||2.088|0.494|0.967
71797203|NCT02365636|143093628|SUPERIORITY||LSM of difference with placebo|2.2||||0.251|TWO_SIDED|95.0|-1.55|5.92||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.92|-1.55|0.251
71797204|NCT02365636|143093628|SUPERIORITY||LSM difference from placebo|1.3||||0.495|TWO_SIDED|95.0|-2.46|5.07||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||5.07|-2.46|0.495
71797205|NCT02365636|143093628|SUPERIORITY||LSM difference from placebo|3.1||||0.123|TWO_SIDED|95.0|-0.84|7.06||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||7.06|-0.84|0.123
71797206|NCT02365636|143093628|SUPERIORITY||LSM difference from placebo|2.8||||0.16|TWO_SIDED|95.0|-1.12|6.77||5% level of significance.|miex model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||6.77|-1.12|0.160
71797207|NCT02365636|143093629|SUPERIORITY||LSM difference from placebo|1.3||||0.609|TWO_SIDED|95.0|-3.81|6.48||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||6.48|-3.81|0.609
71797208|NCT02365636|143093629|SUPERIORITY||LSM difference with placebo|2.1||||0.427|TWO_SIDED|95.0|-3.05|7.19||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.||||7.19|-3.05|0.427
71840432|NCT05698875|143190040|OTHER||Mean Difference (Final Values)|1.4||||0.05|TWO_SIDED|95.0|0.3|2.5||a priori threshold for statistical significance \<0.05 Adjusted with Bonferroni correction|Linear Mixed Model|||HGL meals vs HGLP meals||2.5|0.3|0.05
71797209|NCT02365636|143093630|SUPERIORITY||LSM difference from placebo|0.2||||0.166|TWO_SIDED|95.0|-0.07|0.43||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.43|-0.07|0.166
71797210|NCT02365636|143093630|SUPERIORITY||LSM difference from placebo|0.3||||0.046|TWO_SIDED|95.0|0.0|0.51||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.51|0.00|0.046
71797211|NCT02365636|143093630|SUPERIORITY||LSM difference from placebo|0.2||||0.152|TWO_SIDED|95.0|-0.08|0.53||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.53|-0.08|0.152
71797212|NCT02365636|143093630|SUPERIORITY||LSM difference from placebo|0.1||||0.342|TWO_SIDED|95.0|-0.16|0.46||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.||0.46|-0.16|0.342
71797213|NCT02365636|143093631|SUPERIORITY||LSM difference from placebo|0.2||||0.311|TWO_SIDED|95.0|-0.22|0.7||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.70|-0.22|0.311
71797214|NCT02365636|143093631|SUPERIORITY||LSM difference from placebo|0.3||||0.262|TWO_SIDED|95.0|-0.2|0.73||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.73|-0.20|0.262
71797215|NCT02365636|143093631|SUPERIORITY||LSM difference from placebo|0.5||||0.065|TWO_SIDED|95.0|-0.03|0.97||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.97|-0.03|0.065
71797216|NCT02365636|143093631|SUPERIORITY||LSM difference from placebo|0.3||||0.296|TWO_SIDED|95.0|-0.23|0.76||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.76|-0.23|0.296
71797217|NCT02365636|143093632|SUPERIORITY|||||||0.245||||||5% level of significance|Regression, Cox|||||||0.245
71797218|NCT02365636|143093632|SUPERIORITY|||||||0.304||||||5% level of significance|Regression, Cox|||||||0.304
71797219|NCT02365636|143093633|SUPERIORITY||LSM difference from placebo|-0.1||||0.556|TWO_SIDED|95.0|-0.61|0.33||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.33|-0.61|0.556
71797220|NCT02365636|143093633|SUPERIORITY||LSM difference from placebo|-0.2||||0.482|TWO_SIDED|95.0|-0.65|0.31||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.31|-0.65|0.482
71840433|NCT05698875|143190040|OTHER||Mean Difference (Final Values)|0.34||||0.55|TWO_SIDED|95.0|-0.8|1.5||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||HGL meals vs MGL meals||1.5|-0.8|0.55
71840434|NCT05698875|143190040|OTHER||Mean Difference (Final Values)|1.1||||0.08|TWO_SIDED|95.0|-0.1|2.2||a priori threshold for statistical significance \<0.05|Linear Mixed Model|||MGL meals vs HGLP meals||2.2|-0.1|0.08
71840435|NCT03974178|143190088|OTHER|"The minimal sample size to get a possible rejection of H0 (pdeath = 8.5% or more) in favour of H1 (pdeath \<8.5%) was 34 evaluable patients with stage 2 r-HAT.~The hypothesis was tested with a one-sided exact test for proportions at the 0.05 significance level."|Fatality rate|0.0||||0.0488|TWO_SIDED|90.0|0.0|8.43||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||8.43|0|0.0488
71893365|NCT03352245|143307751|SUPERIORITY||Mean Difference (Net)|5.27|STANDARD_ERROR_OF_MEAN|4.38||0.237|TWO_SIDED||||||Mixed Models Analysis|||||||0.237
71893366|NCT03352245|143307752|SUPERIORITY||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|6.49||0.861|TWO_SIDED||||||Mixed Models Analysis|||||||0.861
71797221|NCT02365636|143093633|SUPERIORITY||LSM difference from placebo|-0.3||||0.333|TWO_SIDED|95.0|-0.81|0.28||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.28|-0.81|0.333
71797222|NCT02365636|143093633|SUPERIORITY||LSM difference from placebo|-0.1||||0.833|TWO_SIDED|95.0|-0.62|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.62|0.833
71797223|NCT02365636|143093634|SUPERIORITY||LSM difference from placebo|-0.2||||0.563|TWO_SIDED|95.0|-0.75|0.41||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.41|-0.75|0.563
71797224|NCT02365636|143093634|SUPERIORITY||LSM difference from placebo|-0.1||||0.804|TWO_SIDED|95.0|-0.64|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.50|-0.64|0.804
71797225|NCT02365636|143093634|SUPERIORITY||LSM difference from placebo|0.1||||0.714|TWO_SIDED|95.0|-0.49|0.71||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.71|-0.49|0.714
71797226|NCT02365636|143093634|SUPERIORITY||LSM difference from placebo|0.0||||0.871|TWO_SIDED|95.0|-0.64|0.55||5% level of siignificance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.||0.55|-0.64|0.871
71797227|NCT01956110|143093658|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing pregnancy rate was demonstrated.|Treatment difference|-0.9|||||TWO_SIDED|95.0|-5.9|4.1||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% confidence interval (CI) derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.1|-5.9|
71797228|NCT01956110|143093659|NON_INFERIORITY|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing implantation rate was demonstrated.|Treatment difference|-0.6|||||TWO_SIDED|95.0|-6.1|4.8||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.8|-6.1|
71797229|NCT01956110|143093660|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.7|3.4||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||3.4|-6.7|
71797230|NCT01956110|143093661|NON_INFERIORITY|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.4|||||TWO_SIDED|95.0|-7.0|4.2||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (\<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.||4.2|-7.0|
71797231|NCT01956110|143093662|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.001||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=15 oocytes retrieved||||=0.001
71797232|NCT01956110|143093662|OTHER|A logistic regression model was fitted to the data including AMH, log(AMH)2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor.|||||=|0.002||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: \<4 or \>=20 oocytes retrieved||||=0.002
71797233|NCT01956110|143093663|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.291||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade)||||=0.291
71797234|NCT01956110|143093663|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.644||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe)||||=0.644
71797235|NCT01956110|143093663|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.005||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Preventive interventions||||=0.005
71893367|NCT02690701|143307760|SUPERIORITY|This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.|Least Square Mean|-0.053|STANDARD_ERROR_OF_MEAN|0.059||0.3712|TWO_SIDED|95.0|-0.169|0.064|||ANCOVA|||Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)||0.064|-0.169|0.3712
71797236|NCT01956110|143093663|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.046||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade) and/or preventive interventions||||=0.046
71797237|NCT01956110|143093663|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0.019||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe) and/or preventive interventions||||=0.019
71797238|NCT01956110|143093664|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35- 37, and 38-40 years) as factors.|Odds Ratio (OR)|1.38|||=|0.302|TWO_SIDED|95.0|0.74|2.57||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison: Cycle cancelled due to poor response||2.57|0.74|=0.302
71797239|NCT01956110|143093664|EQUIVALENCE|Treatment groups were compared using a logistic regression model with treatment and age (\<35, 35-37, and 38-40 years) as factors.|Odds Ratio (OR)|0.42||||0.019|TWO_SIDED|95.0|0.2|0.9||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison:Triggering with GnRH agonist||0.9|0.2|0.019
71797240|NCT01956110|143093665|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.692|||||||van Elteren|||Treatment comparison: Number of oocytes retrieved||||=0.692
71797241|NCT01956110|143093666|OTHER|"A logistic regression model was fitted to the data including AMH, log(AMH)\^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)\^2 in the linear predictor.~A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)\^2 in the linear predictor."|||||=|0.019||||||Inclusion of treatment provides a better fit to the data|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||The relation between ovarian response potential (AMH at screening) and probability of achieving the targeted response was modelled using logistic regression models.||||=0.019
71797242|NCT01956110|143093667|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.909|||||||van Elteren|||Treatment comparison: Number of metaphase II oocytes||||=0.909
71797243|NCT01956110|143093668|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).||||||0.53|||||||van Elteren|||Treatment comparison: Fertilisation rate||||0.53
71797244|NCT01956110|143093669|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.59|||||||van Elteren|||Treatment comparison: Number of embryos||||=0.59
71797245|NCT01956110|143093669|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.414|||||||van Elteren|||Treatment comparison: Good quality embryos||||=0.414
71797246|NCT01956110|143093670|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.344|||||||van Elteren|||Treatment comparison: Number of blastocysts||||= 0.344
71893368|NCT01442181|143307790|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month in minimally invasive group||||0.03
71797247|NCT01956110|143093670|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.58|||||||van Elteren|||Treatment comparison: Good-quality blastocysts||||= 0.58
71797248|NCT01956110|143093671|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||<|0.001|||||||van Elteren|||Treatment comparison: Total gonadotropin dose||||<0.001
71797249|NCT01956110|143093672|EQUIVALENCE|Treatment groups were compared using the van Elteren test adjusted for age (\<35, 35-37, and 38-40 years).|||||=|0.062|||||||van Elteren|||Treatment comparison: Number of stimulation days||||=0.062
71797250|NCT01956110|143093673|EQUIVALENCE|Treatment groups were compared using a chi-square test.|||||=|0.178|||||||Chi-squared|||Treatment comparison: Investigator-requested gonadotropin dose adjustments||||=0.178
71797251|NCT01956110|143093679|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.32||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (any grade)||||0.320
71797252|NCT01956110|143093679|OTHER|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.39||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (moderate/severe)||||0.390
71893369|NCT01442181|143307790|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 month||||0.01
71893370|NCT01442181|143307790|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue in medical therapy group; baseline vs 3 month||||0.49
71893371|NCT01442181|143307790|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month||||0.06
71797253|NCT02506816|143093701|OTHER|The P-valor Wilcoxon method is a non-parametric statistical hypothesis test used to evaluate changes from baseline H-score values of the three biomarkers.||||||0.033||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of 3 biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.033
71797254|NCT02506816|143093702|OTHER|The differences in the change from baseline of different biomarkers were evaluated by the P-valor Wilcoxon method, a non-parametric statistical hypothesis test.||||||0.03||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of several biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.||||0.03
71673983|NCT00529373|142866245|OTHER||Difference in Least Squares Means|11.08|||<|0.001|TWO_SIDED|95.0|8.41|13.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.74|8.41|<0.001
71797255|NCT01236196|143093707|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Mixed Models Analysis|||||||0.11
71797256|NCT01236196|143093708|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71797257|NCT01236196|143093709|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71797258|NCT01236196|143093710|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.09
71797259|NCT01096784|143093714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0642||95.0|||||CMH Row Mean Score Test|||||||0.0642
71840436|NCT03974178|143190089|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0405|TWO_SIDED|90.0|0.0|8.43||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||8.43|0|0.0405
71840437|NCT03974178|143190090|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.94||||0.073|TWO_SIDED|90.0|0.15|13.21||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||13.21|0.15|0.0730
71673984|NCT00529373|142866246|OTHER||Difference in Least Squares Means|10.41|||<|0.001|TWO_SIDED|95.0|8.05|12.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||12.78|8.05|<0.001
71797260|NCT03761628|143093728|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|40.9|||||ONE_SIDED|95.0|23.3|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% CI for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||23.3|
71797261|NCT03761628|143093729|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Proportion with reduction|72.7|||||TWO_SIDED|95.0|49.8|89.3||||||||89.3|49.8|
71797262|NCT03761628|143093731|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|12.5|||||TWO_SIDED|95.0|0.3|52.7||||||||52.7|0.3|
71797263|NCT03761628|143093731|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|45.9||||||||45.9|0|
71797264|NCT05583903|143093732|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71797265|NCT05583903|143093733|SUPERIORITY|||||||0.26|||||||Fisher Exact|||||||0.26
71797266|NCT05583903|143093734|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71797267|NCT05583903|143093735|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71797268|NCT05583903|143093736|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71797269|NCT05583903|143093737|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
71797270|NCT05583903|143093738|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71893372|NCT01642212|143307807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71673985|NCT00529373|142866247|OTHER||Difference in Least Squares Means|9.98|||<|0.001|TWO_SIDED|95.0|6.91|13.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||13.06|6.91|<0.001
71673986|NCT00529373|142866248|OTHER||Difference in Least Squares Means|14.94|||<|0.001|TWO_SIDED|95.0|11.29|18.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo||18.59|11.29|<0.001
71797271|NCT05583903|143093739|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71797272|NCT05583903|143093740|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
71797273|NCT05583903|143093741|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71797274|NCT05583903|143093742|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71797275|NCT05583903|143093743|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71797276|NCT05583903|143093744|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71797277|NCT05583903|143093745|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71797278|NCT05583903|143093746|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71797279|NCT01103934|143093772|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.09
71797280|NCT01103934|143093773|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71797281|NCT02402452|143093778|OTHER||Geometric Least-Square Mean(GLSM)Ratio %|172.92|||||TWO_SIDED|90.0|97.93|305.33||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||305.33|97.93|
71797282|NCT02402452|143093779|OTHER||GLSM Ratio (%)|171.27|||||TWO_SIDED|90.0|97.65|300.38||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||300.38|97.65|
71797283|NCT02402452|143093780|OTHER||GLSM Ratio (%)|145.43|||||TWO_SIDED|90.0|83.77|252.48||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of Cmax for the comparison groups using two 1-sided tests.||252.48|83.77|
71797284|NCT00559962|143093789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07|||ANOVA|||One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.||7.07|2.30|<0.001
71797285|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.92|||<|0.001|TWO_SIDED|95.0|2.27|7.57||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||7.57|2.27|<0.001
71797286|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68|||<|0.001|TWO_SIDED|95.0|2.3|7.07||(All comparisons)|ANOVA|||||7.07|2.30|<0.001
71797287|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.91|||<|0.001|TWO_SIDED|95.0|1.73|6.1||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||6.10|1.73|<0.001
71797288|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.82|||<|0.001|TWO_SIDED|95.0|4.31|11.33||(All comparisons)|ANOVA|||||11.33|4.31|<0.001
71797289|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||<|0.001|TWO_SIDED|95.0|1.58|5.72||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||5.72|1.58|<0.001
71797290|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||<|0.001|TWO_SIDED|95.0|4.22|11.11||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||11.11|4.22|<0.001
71840438|NCT03974178|143190093|OTHER|The hypothesis H0 (pdeath = 8.5% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Fatality rate|0.0||||0.0201|TWO_SIDED|90.0|0.0|6.58||The rate of deaths possibly related to r-HAT or to fexinidazole at the end of hospitalization was compared to the predefined unacceptable rate of 8.5%.|one-sided exact test|Clopper Pearson exact method||"The proportion of deaths (pdeath) is compared to the threshold of 8.5%, with H0 being pdeath = 8.5% or more.~The 90% confidence interval of the fatality rate is calculated with the Clopper-Pearson method."||6.58|0|0.0201
71840439|NCT03974178|143190094|OTHER|The hypothesis H0 (pfailure at the end of hospitalization = 9% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|0.0||||0.0158|TWO_SIDED|90.0|0.0|6.58||The rate of failures at the end of hospitalization was compared to the predefined unacceptable rate of 9%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at the end of hospitalization (pfailure) is compared to the threshold of 9%, with H0 being pfailure = 9% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||6.58|0|0.0158
71797291|NCT00559962|143093790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.51|||<|0.001|TWO_SIDED|95.0|5.16|9.86||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo||9.86|5.16|<0.001
71797292|NCT05422053|143093807|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of Control-IQ Use (13 Weeks) compared to Control-IQ Start||||<0.001
71797293|NCT02439775|143093830|SUPERIORITY|||||||0.1194||||||p\<0.05 required for significance|ANCOVA|||||||0.1194
71797294|NCT00915798|143093876|SUPERIORITY_OR_OTHER||F|0.56||||0.46|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD during abstinence in smokers and nonsmokers||||0.46
71797295|NCT00915798|143093876|SUPERIORITY_OR_OTHER||F|6.64||||0.012|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Diagnosis by smoking status interaction.|Parietal BOLD during abstinence in smokers and nonsmokers||||0.012
71797296|NCT00915798|143093876|SUPERIORITY_OR_OTHER||F|211.2||||0.04|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05|Main effect for smoking status.|Occipital BOLD during abstinence in smokers and nonsmokers.||||0.04
71797297|NCT00915798|143093876|SUPERIORITY_OR_OTHER||F|1.6||||0.22|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Frontal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.22
71797298|NCT00915798|143093876|SUPERIORITY_OR_OTHER||F|0.43||||0.51|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Parietal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.51
71797299|NCT00915798|143093876|SUPERIORITY_OR_OTHER||F|0.16||||0.69|TWO_SIDED||||||ANOVA|Threshold for statistical significance p \< 0.05||Occipital BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.||||0.69
71797300|NCT02244580|143093906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0018|TWO_SIDED|95.0|0.246|0.726|||Regression, Cox|||||0.726|0.246|0.0018
71797301|NCT02244580|143093907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.001|TWO_SIDED|95.0|0.25|0.71|||Regression, Cox|||||0.71|0.25|0.001
71797302|NCT03465878|143093990|SUPERIORITY||Ratio of geometric least squares means|0.999||||0.9813|TWO_SIDED|95.0|0.918|1.09|||Mixed Models Analysis|||||1.09|0.918|0.9813
71797303|NCT03465878|143093990|SUPERIORITY||Ratio of geometric least squares means|1.06||||0.1638|TWO_SIDED|95.0|0.976|1.15|||Mixed Models Analysis|||||1.15|0.976|0.1638
71797304|NCT03465878|143093990|SUPERIORITY||Ratio of geometric least squares means|1.01||||0.7623|TWO_SIDED|95.0|0.933|1.1|||Mixed Models Analysis|||||1.10|0.933|0.7623
71797305|NCT03465878|143093990|SUPERIORITY||Ratio of geometric least squares means|1.04||||0.2952|TWO_SIDED|95.0|0.962|1.13|||Mixed Models Analysis|||||1.13|0.962|0.2952
71797306|NCT03465878|143093990|SUPERIORITY||Ratio of geometric least squares means|0.97||||0.4052|TWO_SIDED|95.0|0.901|1.04|||Mixed Models Analysis|||||1.04|0.901|0.4052
71797307|NCT03465878|143093990|SUPERIORITY||Ratio of geometric least squares means|1.02||||0.5314|TWO_SIDED|95.0|0.948|1.11|||Mixed Models Analysis|||||1.11|0.948|0.5314
71797308|NCT03925727|143093992|SUPERIORITY||Mean Difference (Net)|1.4||||0.5533|TWO_SIDED|95.0|-3.2|6.0|||ANCOVA|||||6|-3.2|0.5533
71673987|NCT00529373|142866249|OTHER||Hazard Ratio (HR)|0.79||||0.366|TWO_SIDED|95.0|0.47|1.33|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.33|0.47|0.366
71673988|NCT00529373|142866250|OTHER||Hazard Ratio (HR)|1.13||||0.246|TWO_SIDED|95.0|0.92|1.4|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.4|0.92|0.246
71673989|NCT00529373|142866251|OTHER||Hazard Ratio (HR)|0.8||||0.638|TWO_SIDED|95.0|0.32|2.03|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.03|0.32|0.638
71673990|NCT00529373|142866252|OTHER||Hazard Ratio (HR)|1.17||||0.029|TWO_SIDED|95.0|1.02|1.36|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.36|1.02|0.029
71673991|NCT00529373|142866253|OTHER||Hazard Ratio (HR)|1.05||||0.341|TWO_SIDED|95.0|0.95|1.17|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.17|0.95|0.341
71797309|NCT03925727|143093993|SUPERIORITY||Mean Difference (Net)|-0.6||||0.0192|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.0192
71797310|NCT00773175|143094022|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.5||||0.5064|TWO_SIDED|95.0|-221.2|86.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.2|-221.2|0.5064
71797311|NCT00773175|143094022|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.0||||0.0325|TWO_SIDED|95.0|-54.6|102.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||102.7|-54.6|0.0325
71797312|NCT00773175|143094023|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-174.7||||0.8915|TWO_SIDED|95.0|-340.3|-9.1||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||-9.1|-340.3|0.8915
71797313|NCT00773175|143094023|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-58.6||||0.5469|TWO_SIDED|95.0|-137.5|20.3||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||20.3|-137.5|0.5469
71797314|NCT00773175|143094025|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.0||||0.5035|TWO_SIDED|95.0|-220.6|86.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous|||86.7|-220.6|0.5035
71797315|NCT00773175|143094025|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.6||||0.0314|TWO_SIDED|95.0|-54.0|103.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous|||103.2|-54.0|0.0314
71797316|NCT00773175|143094029|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
71797317|NCT00773175|143094029|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
71673992|NCT00529373|142866254|OTHER||Hazard Ratio (HR)|1.23||||0.198|TWO_SIDED|95.0|0.9|1.68|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.68|0.9|0.198
71673993|NCT00529373|142866255|OTHER||Hazard Ratio (HR)|0.94||||0.798|TWO_SIDED|95.0|0.7|1.26|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.26|0.7|0.798
71673994|NCT00529373|142866256|OTHER||Hazard Ratio (HR)|1.37||||0.005|TWO_SIDED|95.0|1.1|1.71|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.71|1.1|0.005
71673995|NCT00529373|142866257|OTHER||Hazard Ratio (HR)|1.22||||0.059|TWO_SIDED|95.0|0.99|1.5|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.5|0.99|0.059
71893373|NCT01642212|143307808|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.75||||0.0096|TWO_SIDED|95.0|-11.808|-1.687||LS mean estimates were determined using an ANCOVA model including treatment group as a factor and the baseline score as a covariate.|ANCOVA|||||-1.687|-11.808|0.0096
71673996|NCT00529373|142866258|OTHER||Hazard Ratio (HR)|1.61||||0.114|TWO_SIDED|95.0|0.89|2.9|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||2.9|0.89|0.114
71673997|NCT00529373|142866259|OTHER||Hazard Ratio (HR)|1.14||||0.159|TWO_SIDED|95.0|0.99|1.31|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.31|0.99|0.159
71797318|NCT00773175|143094030|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||TWO_SIDED|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||9.4|-69.5|
71797319|NCT00773175|143094030|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||TWO_SIDED|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||-3.1|-77.3|
71797320|NCT00773175|143094032|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|0.3|5.5|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||5.5|0.3|
71797321|NCT00773175|143094032|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-0.2|4.7|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||4.7|-0.2|
71797322|NCT00773175|143094033|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.8|1.9|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay|||1.9|-2.8|
71797323|NCT00773175|143094033|NON_INFERIORITY|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only|||0.8|-3.4|
71797324|NCT00773175|143094044|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|0.1|0.3|||||Treatment difference = SC minus IV|||0.3|0.1|
71797325|NCT00773175|143094045|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.0658|TWO_SIDED|95.0|-0.9|0.0|||ANOVA|From Analysis of Variance (ANOVA) model with center and treatment as factors.|Treatment difference = SC minus IV.|||0.0|-0.9|0.0658
71797326|NCT00773175|143094046|SUPERIORITY||Mean Difference (Net)|-1.0||||0.6208|TWO_SIDED|95.0|-4.8|2.9|||ANOVA|From ANOVA model with center and treatment as factors|Treatment difference = SC minus IV|||2.9|-4.8|0.6208
71797327|NCT00773175|143094048|SUPERIORITY|||||||0.0685||||||Cochran-Mantel-Haenszel (CMH) test controlling for center|Cochran-Mantel-Haenszel|Question 1||||||0.0685
71797328|NCT00773175|143094048|SUPERIORITY|||||||0.0004||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||0.0004
71797329|NCT00773175|143094048|SUPERIORITY|||||||0.6861||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 3||||||0.6861
71797330|NCT00773175|143094048|SUPERIORITY|||||||0.2323||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.2323
71893374|NCT01642212|143307809|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.49||||0.2649|TWO_SIDED|95.0|-6.895|1.92||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.920|-6.895|0.2649
71797331|NCT00773175|143094049|SUPERIORITY|||||||0.0033||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Effectiveness||||||0.0033
71797332|NCT00773175|143094049|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Degree of difficulty||||||< 0.0001
71797333|NCT00773175|143094050|SUPERIORITY|||||||0.2012||||||CMH test controlling for Center|Cochran-Mantel-Haenszel|Question 1||||||0.2012
71797334|NCT00773175|143094050|SUPERIORITY||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2||||||< 0.0001
71797335|NCT00773175|143094050|SUPERIORITY|||||||0.1302||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4||||||0.1302
71797336|NCT00773175|143094050|SUPERIORITY|||||||0.0852||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 5||||||0.0852
71797337|NCT00773175|143094050|SUPERIORITY|||||||0.0275||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 6||||||0.0275
71797338|NCT00773175|143094056|SUPERIORITY|||||||0.0247|||||||Wilcoxon (Mann-Whitney)|||||||0.0247
71797339|NCT00773175|143094057|SUPERIORITY|||||||0.0007||||||CMH test controlling for center|Cochran-Mantel-Haenszel|||||||0.0007
71797340|NCT04127786|143094103|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95 percent (%) confidence interval (CI) of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was greater than (\>) -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
71797341|NCT04127786|143094103|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|1.2|||||TWO_SIDED|95.0|-0.6|6.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 2: Verorab®: Adult (\>=18 years)||6.4|-0.6|
71797342|NCT04127786|143094103|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Pediatric (\< 18 years)||4.4|-1.4|
71797343|NCT04127786|143094103|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentages between the test group (Group 1) and control groups (Group 2, Group 3) was \> -5% at Day 42.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.5|4.6||||||Primary Series: Cohort-I Group 1: VRVg-2 versus Primary Series: Cohort-I Group 3: Imovax Rabies: Adult (\>= 18 years)||4.6|-1.5|
71797344|NCT04127786|143094104|SUPERIORITY|If the non-inferiority for VRVg-2 versus comparator vaccines was reached at Day 42, then superiority was demonstrated if the overall observed percentage of participants with an RVNA titer \>= 0.5 IU/mL at Day 42 was at least 99% in the VRVg-2 Group, with the lower limit of the 95% CI at least 97%.|Percentage Difference|100.0|||||TWO_SIDED|95.0|99.3|100.0||||||The secondary immunogenicity outcome measures were evaluated sequentially following a fixed-sequence method.||100|99.3|
71797345|NCT04127786|143094105|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Pediatric (\< 18 years)||4.3|-1.4|
71797346|NCT04127786|143094105|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|-0.2|||||TWO_SIDED|95.0|-1.9|2.7||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 2 and 5: Verorab®: Adult (\>=18 years)||2.7|-1.9|
71840440|NCT03974178|143190095|OTHER|The hypothesis H0 (pfailure at 12 months = 12% or more) was tested with a one-sided exact test for proportions at the 0.05 significance level.|Failure rate|2.27||||0.0253|TWO_SIDED|90.0|0.12|10.34||The rate of failures at 12 months was compared to the predefined unacceptable rate of 12%.|one-sided exact test|Clopper Pearson exact method||"The proportion of failures at 12 months (pfailure) is compared to the threshold of 12%, with H0 being pfailure = 12% or more.~The 90% confidence interval of the failure rate is calculated with the Clopper-Pearson method."||10.34|0.12|0.0253
71797347|NCT04127786|143094105|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.5||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Pediatric (\< 18 years)||4.5|-1.4|
71840441|NCT04508309|143190099|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.09|||||TWO_SIDED|98.3|0.891|1.327|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.327|0.891|
71840442|NCT04508309|143190099|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.78|||||TWO_SIDED|98.3|1.455|2.176|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% CI was used.||2.176|1.455|
71893375|NCT01642212|143307809|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.91||||0.2878|TWO_SIDED|95.0|-8.322|2.501||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||2.501|-8.322|0.2878
71893376|NCT01642212|143307811|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 15 Eosinophils/HPF||||0.0001
71893377|NCT01642212|143307811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||Analysis of \</= 1 Eosinophils/HPF||||<0.0001
71893378|NCT01642212|143307812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ score reduction||||0.0206
71893379|NCT01642212|143307812|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0275|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ score reduction||||0.0275
71893380|NCT01642212|143307813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 30% DSQ score reduction||||0.0026
71893381|NCT01642212|143307813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|TWO_SIDED||||||Fisher Exact|||Analysis of response and \>/= 50% DSQ score reduction||||0.0199
71893382|NCT01642212|143307814|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-22.34|||<|0.0001|TWO_SIDED|95.0|-30.345|-14.334|||ANCOVA|LS mean based on the ANCOVA model including treatment group as a factor and baseline as a covariate.||||-14.334|-30.345|<0.0001
71893383|NCT01642212|143307815|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.76|||<|0.0001|TWO_SIDED|95.0|-5.172|-2.358||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-2.358|-5.172|<0.0001
71893384|NCT01642212|143307816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-35.5||||0.0002|TWO_SIDED|95.0|-53.438|-17.57||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of proximal eosinophil count||-17.570|-53.438|0.0002
71893385|NCT01642212|143307816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-59.56|||<|0.0001|TWO_SIDED|95.0|-84.173|-34.948||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of mid- eosinophil count||-34.948|-84.173|<0.0001
71893386|NCT01642212|143307816|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-67.38|||<|0.0001|TWO_SIDED|95.0|-93.573|-41.18||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of distal eosinophil count||-41.180|-93.573|<0.0001
71893387|NCT01642212|143307817|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.44||||0.0015|TWO_SIDED|95.0|-29.593|-7.293||LS mean estimates were based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||||-7.293|-29.593|0.0015
71893388|NCT01642212|143307818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|TWO_SIDED|||||P-value for comparison of the treatment difference was determined by Cochran-Mantel-Haenszel row mean score test.|Cochran-Mantel-Haenszel|||Analysis of distribution of scores across all responses||||0.1170
71893389|NCT01642212|143307819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1947|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of heartburn||||0.1947
71797348|NCT04127786|143094105|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the test groups (Groups 1+4) and control groups (Groups 2+5, Groups 3+6) was \> -5% at Day 28.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-0.5|5.3||||||Pooled Groups 1 and 4: VRVg-2 versus Pooled Groups 3 and 6: Imovax Rabies®: Adult (\>= 18 years)||5.3|-0.5|
71797349|NCT04127786|143094106|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.4|4.4|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Pediatric (\< 18 years)||4.4|-1.4|
71797350|NCT04127786|143094106|NON_INFERIORITY|If the non-inferiority objective for VRVg-2 versus comparator vaccines at Day 28 was demonstrated, the overall non-inferiority of 2-dose VRVg-2 at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the non-inferiority between pooled Groups 1+4 and Group 3 were both demonstrated in each age group.|Percentage Difference|-1.7|||||TWO_SIDED|95.0|-3.1|3.0|||||Non-inferiority was demonstrated if the lower limit of the 95% CI of the difference of the percentage between 2-dose VRVg-2 at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Pooled Groups 1 and 4: VRVg-2 at Day 28 versus Primary Series: Cohort-1 Group 3: Imovax Rabies® at Day 42: Adult (\>= 18 years)||3.0|-3.1|
71797351|NCT04127786|143094108|NON_INFERIORITY|If the superiority objective of VRVg-2 was reached at Day 28, the non-inferiority of 2-dose Imovax Rabies® at Day 28 versus 3-dose Imovax Rabies® at Day 42 was demonstrated if the lower limit of the 95% CI of the difference of the percentage between the 2-dose Imovax Rabies® at Day 28 and 3-dose Imovax Rabies® at Day 42 was \> -10%.|Percentage Difference|-1.3|||||TWO_SIDED|95.0|-4.4|1.3||||||Imovax Rabies® at Day 28 versus Imovax Rabies® at Day 42||1.3|-4.4|
71797352|NCT01904604|143094133|SUPERIORITY_OR_OTHER||Risk Difference (RD)|33.8||||0.005|TWO_SIDED|33.8|10.2|57.5||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||57.5|10.2|0.005
71797353|NCT01904604|143094133|SUPERIORITY_OR_OTHER||Risk Difference (RD)|36.0||||0.003|TWO_SIDED|36.0|12.6|59.4||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.||59.4|12.6|0.003
71797354|NCT01904604|143094133|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.2||||0.48|TWO_SIDED|2.2|-25.8|30.1||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||||30.1|-25.8|0.48
71797355|NCT01904604|143094137|SUPERIORITY_OR_OTHER|||||||0.8||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.80
71797356|NCT01904604|143094137|SUPERIORITY_OR_OTHER|||||||0.008||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.008
71840443|NCT04508309|143190099|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|2.37|||||TWO_SIDED|98.3|1.942|2.903|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.903|1.942|
71797357|NCT01904604|143094137|SUPERIORITY_OR_OTHER|||||||0.01||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.||||0.01
71797358|NCT05124665|143094141|EQUIVALENCE|Hypothesis is that proportion of contacts accepting HIV testing between two study arms is equivalent.|Odds Ratio (OR)|4.6||||0.004|TWO_SIDED|95.0|1.6|12.9|||Mixed Models Analysis|Cluster adjusted for household.||||12.9|1.6|0.004
71797359|NCT05124665|143094141|EQUIVALENCE|Hypothesis is proportion of contacts accepting HIV testing is equivalent between the two study arms|Mean Difference (Net)|6.0||||0.006|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided||Estimated value and confidence interval reflects the values multiplied by 100 (converting decimal to percentage).|||10|2|0.006
71797360|NCT05124665|143094142|EQUIVALENCE|Hypothesis is that the change in stigma score is equivalent between the two study arms.|Slope|2.2||||0.358|TWO_SIDED|95.0|-2.5|6.9|||Mixed Models Analysis|||Van Rie Perceived TB and HIV Stigma scales adapted and validated in the Ugandan context are used. Scores range from 0 to 100 (standardized scale)||6.9|-2.5|0.358
71797361|NCT05124665|143094143|EQUIVALENCE|Hypothesis is that the difference in stigma score is equivalent between the two study arms|Slope|2.61||||0.199|TWO_SIDED|95.0|-1.38|6.59|||Mixed Models Analysis|||||6.59|-1.38|0.199
71797362|NCT05124665|143094144|EQUIVALENCE|Hypothesis is no effect from perceived HIV Stigma on HIV Test Uptake|Coefficient from Structural Equation|0.00087||||0.03|TWO_SIDED|95.0|0.00007|0.00167|||Structural Equation Modeling|||||0.00167|0.00007|0.03
71797363|NCT05124665|143094145|EQUIVALENCE|Hypothesis is that TB stigma has no effect of HIV test uptake|Coefficient Structural Equation Model|0.0002||||0.64|TWO_SIDED|95.0|-0.0007|0.0011|||Structural Equation Modeling|||||0.0011|-0.0007|0.64
71797364|NCT05124665|143094146|EQUIVALENCE|Hypothesis is that proportion of index patient nominated household contacts accepting HIV testing is equivalent between two study arms||||||0.452|||||||Chi-squared|||||||0.452
71797365|NCT05124665|143094147|NON_INFERIORITY|Hypothesis is that the first tester's decision to test does not impact subsequent household contacts decision to test for HIV.|Risk Ratio (RR)|1.23||||0.264|TWO_SIDED|95.0|0.86|1.76|||Regression, Logistic|||||1.76|0.86|0.264
71797366|NCT05124665|143094148|EQUIVALENCE|Hypothesis is that the index patient and contact nominations will match equally regardless of study arm.|||||<|0.001|||||||Chi-squared|||||||<0.001
71797367|NCT04144166|143094193|OTHER||||||||||||||See above|||"Mean value for visual CRT and median value for device CRI were calculated for each participant. 3 values were measured (each) for CRT and CRI. Mean value is equal to SUM(m1,m2,m3)/3.~Median value was then calculated for the set (57) of calculated mean visual CRT and mean device CRI. Median value is equal to the middle value of the series of mean values. All measurements are in units of seconds."|See above|||
71797368|NCT01481116|143094204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
71797369|NCT01481116|143094204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
71797370|NCT01481116|143094204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
71797371|NCT01481116|143094204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.||0.18|0.09|<0.001
71797372|NCT01481116|143094205|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.707||0.065|TWO_SIDED|95.0|-2.7|0.08||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||0.08|-2.70|0.065
71797373|NCT01481116|143094205|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.678||0.034|TWO_SIDED|95.0|-2.78|-0.11||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78||-0.11|-2.78|0.034
71797374|NCT00640510|143094210|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||A sample size of at least 15 patients per group was necessary to verify that the decrease in PANSS-EC total score was significantly greater in the IM olanzapine group than the placebo group using Student's t-test with a power of 90% at a two-sided significance level of 5%.||||0.940
71893390|NCT01642212|143307819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8029|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of chest pain||||0.8029
71797375|NCT00640510|143094211|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Change from Baseline to 15 minutes. Change = Timepoint minus Baseline.|t-test, 2 sided|||||||1.000
71797376|NCT00640510|143094211|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||P-value for Change from Baseline to 30 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.620
71797377|NCT00640510|143094211|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Change from Baseline to 60 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.784
71797378|NCT00640510|143094211|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value for Change from Baseline to 90 minutes. Change = Timepoint minus baseline.|t-test, 2 sided|||||||0.756
71797379|NCT00640510|143094212|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
71797380|NCT00640510|143094213|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 30 Minutes.|Fisher Exact|||||||1.000
71797381|NCT00640510|143094213|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 60 Minutes.|Fisher Exact|||||||1.000
71797382|NCT00640510|143094213|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 90 Minutes.|Fisher Exact|||||||1.000
71797383|NCT00640510|143094213|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for 2 Hours.|Fisher Exact|||||||1.000
71797384|NCT04649151|143094294|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on geometric least squares means \[GLSM\]) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|1.078|||||TWO_SIDED|95.0|0.94|1.237|||||GMR of P203 vs P301|||1.237|0.940|
71797385|NCT04649151|143094295|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%. and a point estimator \>-5% (minimum threshold)|percentage difference|-0.2|||||TWO_SIDED|95.0|-2.1|1.9|||||SRR difference of P203 vs P301|||1.9|-2.1|
71797386|NCT04649151|143094296|NON_INFERIORITY|The lower bound of the 95% CI of noninferiority margin of 1.5. GMR point estimate \>=0.8 (minimum threshold).|GMR|5.071|||||TWO_SIDED|95.0|4.477|5.745|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.745|4.477|
71673998|NCT00529373|142866260|OTHER||Hazard Ratio (HR)|1.17||||0.178|TWO_SIDED|95.0|0.93|1.46|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo||1.46|0.93|0.178
71673999|NCT00529373|142866261|OTHER|Miettinen \& Nurminen|Difference in rates|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||||0.09|-0.01|
71674000|NCT00529373|142866262|OTHER|Miettinen \& Nurminen|Difference in rates|0.02|||||TWO_SIDED|95.0|0.01|0.05||||||||0.05|0.01|
71674001|NCT00529373|142866263|OTHER|Miettinen \& Nurminen|Difference in rates|0.06|||||TWO_SIDED|95.0|0.03|0.11||||||||0.11|0.03|
71674002|NCT00529373|142866264|OTHER|Miettinen \& Nurminen|Difference in rates|0.03|||||TWO_SIDED|95.0|0.02|0.06||||||||0.06|0.02|
71797387|NCT04649151|143094297|NON_INFERIORITY|Noninferiority margin of 10%. Lower bound of the 95% CI of the SRR difference \>-10%.|SRR Difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4|||||SRR difference of P203 BD-Day 29 vs P301 Day 57|||2.4|-0.8|
71797388|NCT04649151|143094298|SUPERIORITY|The superiority of GMC (based on GLSM\] was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>1|GMR|48.191|||||TWO_SIDED|95.0|43.765|53.065|||||GMR of P203 vs P301|||53.065|43.765|
71674003|NCT03627546|142866286|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71674004|NCT03627546|142866287|SUPERIORITY|||||||0.0007|||||||Chi-squared|||||||0.0007
71674005|NCT00615550|142866291|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92|||Cochran-Mantel-Haenszel|||||0.92|0.33|0.020
71674006|NCT00615550|142866292|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Cochran-Mantel-Haenszel|||Statistical analysis presented for composite score data.||||0.048
71674007|NCT00615550|142866292|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.39||||0.026|TWO_SIDED|95.0|0.17|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for RDS data.||0.92|0.17|0.026
71797389|NCT04649151|143094301|NON_INFERIORITY|The noninferiority of Geometric Mean value (based on GLSM) was considered demonstrated if: The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).|GMR|4.493|||||TWO_SIDED|95.0|3.972|5.083|||||GMR of GMC at BD-Day 29 P203 vs GMC at Day 57 P301|||5.083|3.972|
71797390|NCT04649151|143094304|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|60.3|||||TWO_SIDED|95.0|26.6|78.6|||VE|Vaccine efficacy (VE, percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||78.6|26.6|
71797391|NCT04649151|143094305|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|43.5|||||TWO_SIDED|95.0|-16.5|72.2|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||72.2|-16.5|
71797392|NCT04649151|143094306|OTHER||VE|100.0|||||TWO_SIDED|95.0|61.2||NA = not estimable (not reached).||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.||||61.2|
71797393|NCT04649151|143094307|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|VE|89.9|||||TWO_SIDED|95.0|51.0|98.9|||VE|VE (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).||||98.9|51.0|
71674008|NCT00615550|142866293|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5||||0.036|TWO_SIDED|95.0|0.25|0.97|||Cochran-Mantel-Haenszel|||Statistical analysis presented for births \<=27 6/7 weeks data.||0.97|0.25|0.036
71674009|NCT00615550|142866293|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.016|TWO_SIDED|95.0|0.42|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<= 34 6/7 weeks data.||0.92|0.42|0.016
71674010|NCT00615550|142866293|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Cochran-Mantel-Haenszel|||Statistical analysis presented for \<36 weeks data.||1.16|0.68|0.376
71674011|NCT00615550|142866294|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.431|TWO_SIDED|95.0|0.14|2.35|||Cochran-Mantel-Haenszel|||||2.35|0.14|0.431
71674012|NCT00615550|142866295|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.26|0.85|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 1500 grams data.||0.85|0.26|0.01
71674013|NCT00615550|142866295|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.213|TWO_SIDED|95.0|0.62|1.11|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight \< 2500 grams data.||1.11|0.62|0.213
71674014|NCT02640664|142866311|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|2.93|||TWO_SIDED|95.0|-1.1|10.5||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||10.5|-1.1|
71674015|NCT02640664|142866311|SUPERIORITY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-3.4|8.3||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||8.3|-3.4|
71674016|NCT02640664|142866311|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|95.0|-3.3|7.8||primary endpoint in the extension study does not have p-values. It's a descriptive analysis.|ANOVA|||||7.8|-3.3|
71674017|NCT02640664|142866314|SUPERIORITY||Mean Difference (Net)|8.0|STANDARD_ERROR_OF_MEAN|4.42|||TWO_SIDED|95.0|-0.8|16.7||P value not applicable because it's a descriptive analysis.|ANOVA|||||16.7|-0.8|
71674018|NCT02640664|142866314|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-7.3|10.5||P value not applicable because it's a descriptive analysis.|ANOVA|||||10.5|-7.3|
71674019|NCT02640664|142866314|SUPERIORITY||Mean Difference (Net)|6.4|STANDARD_ERROR_OF_MEAN|4.24|||TWO_SIDED|95.0|-2.0|14.8|||ANOVA|||||14.8|-2.0|
71674020|NCT02640950|142866396|SUPERIORITY||||||<|0.001||||||Paired t test for pre and post treatment scores for all subjects|t-test, 2 sided|||Paired t-test of pre and post treatment scores on MADRS||||<0.001
71674021|NCT02640950|142866397|OTHER|Descriptive Frequencies Analysis|||||||||||||||||A frequencies analysis was conducted to determine the number of participants that were diagnosed with BP I and BP II as well as the number of participants that developed an onset of maniac symptoms during the 7 week treatment period.|||
71674022|NCT00915018|142866402|SUPERIORITY||Hazard Ratio (HR)|1.015||||0.8934|TWO_SIDED|95.0|0.813|1.269|||Log Rank|||||1.269|0.813|0.8934
71674023|NCT00915018|142866403|OTHER||Risk Difference (RD)|0.028||||0.5219|TWO_SIDED|95.0|-0.048|0.105|||Mantel Haenszel|||||0.105|-0.048|0.5219
71674024|NCT00915018|142866404|OTHER||Hazard Ratio (HR)|0.974||||0.8431|TWO_SIDED|95.0|0.752|1.262|||Log Rank|||||1.262|0.752|0.8431
71797394|NCT03907683|143094324|SUPERIORITY||Mean Difference (Final Values)|0.16412|STANDARD_ERROR_OF_MEAN|0.08||0.037|TWO_SIDED|95.0|0.0098|0.3185|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday move more messages would not differ from zero||0.3185|.0098|0.037
71797395|NCT03907683|143094324|SUPERIORITY||Mean Difference (Net)|0.12538|STANDARD_ERROR_OF_MEAN|0.07674||0.106|TWO_SIDED|95.0|-0.0274|0.2781|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday sit less messages would not differ from zero||0.2781|-0.0274|.106
71797396|NCT03907683|143094324|SUPERIORITY||Mean Difference (Net)|0.24738|STANDARD_ERROR_OF_MEAN|0.13746||0.076|TWO_SIDED|95.0|-0.0262|0.521|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekday inspirational quote messages would not differ from zero||.5210|-.0262|.076
71797397|NCT03907683|143094324|SUPERIORITY||Mean Difference (Net)|0.30563|STANDARD_ERROR_OF_MEAN|0.16136||0.062|TWO_SIDED|95.0|-0.0156|0.6268|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend move more messages would not differ from zero||.6268|-.0156|.062
71674025|NCT00915018|142866405|OTHER||Risk Difference (RD)|-0.032||||0.236|TWO_SIDED|95.0|-0.093|0.029|||Mantel Haenszel|||||0.029|-0.093|0.2360
71674026|NCT00915018|142866406|OTHER||Hazard Ratio (HR)|0.449||||0.0036|TWO_SIDED|95.0|0.259|0.78|||Log Rank|||||0.780|0.259|0.0036
71797398|NCT03907683|143094324|SUPERIORITY||Mean Difference (Net)|0.277|STANDARD_ERROR_OF_MEAN|0.10676||0.11|TWO_SIDED|95.0|0.0645|0.4895|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend sit less messages would not differ from zero||.4895|.0645|0.11
71797399|NCT03907683|143094324|SUPERIORITY||Mean Difference (Net)|0.10837|STANDARD_ERROR_OF_MEAN|0.16895||0.523|TWO_SIDED|95.0|-0.2279|0.4447|||t-test, 2 sided|||Null hypothesis was that the mean steady state response to weekend inspirational quote messages would not differ from zero||0.4447|-0.2279|.523
71797400|NCT03400332|143094348|OTHER||Hazard Ratio, log|0.94||||0.7416|TWO_SIDED|95.0|0.61|1.45|||Log Rank|||||1.45|0.61|0.7416
71797401|NCT02704364|143094411|SUPERIORITY||Hodges-Lehmann estimate|-14.0|STANDARD_ERROR_OF_MEAN|21.4||0.434|TWO_SIDED|95.0|-68.0|28.0|||Wilcoxon (Mann-Whitney)|||||28.0|-68.0|0.434
71797402|NCT02704364|143094411|SUPERIORITY||Hodges-Lehmann estimate|13.0|STANDARD_ERROR_OF_MEAN|25.0||0.646|TWO_SIDED|95.0|-41.0|71.0|||Wilcoxon (Mann-Whitney)|||||71.0|-41.0|0.646
71674027|NCT00300885|142866448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.915||95.0|0.94|1.41||According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.|Log Rank||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta\>=1, Alternative: theta\<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.||1.41|0.94|0.915
71674028|NCT00300885|142866449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.433||95.0|0.84|1.16|||Log Rank|||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with alpha of 0.025 stratified by same stratification factors at randomization||1.16|0.84|0.433
71674029|NCT00300885|142866450|SUPERIORITY_OR_OTHER||difference in response rate (CR+PR rate)|-3.65||||0.1015||95.0|-9.18|1.89||no adjustments|Cochran-Mantel-Haenszel||difference in response rates (Complete Response (CR) + Partial Response (PR)) = Placebo+C/P - Sorafenib+C/P|Objective response rate (ie. CR+PR rate) was compared between treatment arms using Cochran-Mantel-Haenszel test with one-side alpha 0.025 adjusting for same stratification factors as randomization||1.89|-9.18|0.1015
71797403|NCT02975934|143094429|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.69|||Log Rank|||||0.69|0.36|<0.001
71797404|NCT02975934|143094430|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.80|0.47|<0.001
71797405|NCT02975934|143094431|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5044|TWO_SIDED|95.0|0.68|1.2|||Log Rank|||||1.20|0.68|0.5044
71797406|NCT02975934|143094432|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9368|TWO_SIDED|95.0|0.78|1.26|||Log Rank|||||1.26|0.78|0.9368
71797407|NCT02075840|143094460|SUPERIORITY||Hazard Ratio, stratified|0.47|||<|0.0001|TWO_SIDED|95.0|0.34|0.65|||Log Rank|||Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||0.65|0.34|<0.0001
71797408|NCT02075840|143094462|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.||||0.70|0.36|<0.0001
71797409|NCT02075840|143094464|SUPERIORITY|IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)|Cause-Specific Hazard Ratio|0.16|||<|0.0001|TWO_SIDED|95.0|0.1|0.28|||Log Rank|||||0.28|0.10|<0.0001
71797410|NCT02075840|143094466|SUPERIORITY||Difference in Overall Response Rates|7.4||||0.0936|TWO_SIDED|95.0|-1.71|16.5||Stratified analysis|Mantel Haenszel|||||16.50|-1.71|0.0936
71797411|NCT02075840|143094468|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.2405|TWO_SIDED|95.0|0.48|1.2||Stratified analysis|Log Rank|||||1.20|0.48|0.2405
71797412|NCT02075840|143094479|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2079|TWO_SIDED|95.0|0.46|1.19|||Log Rank|Stratified analysis||Fatigue||1.19|0.46|0.2079
71797413|NCT02075840|143094479|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.1137|TWO_SIDED|95.0|0.88|3.15||Stratified analysis|Log Rank|||Dyspnea||3.15|0.88|0.1137
71797414|NCT02075840|143094481|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.7042|TWO_SIDED|95.0|0.44|1.74||Stratified analysis|Log Rank|||Coughing||1.74|0.44|0.7042
71797415|NCT02075840|143094481|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0285|TWO_SIDED|95.0|1.05|2.92||Stratified analysis|Log Rank|||Dyspnea||2.92|1.05|0.0285
71797416|NCT02075840|143094481|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.2377|TWO_SIDED|95.0|0.79|2.61||Stratified analysis|Log Rank|||Pain in arm and shoulder||2.61|0.79|0.2377
71797417|NCT02075840|143094481|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0796|TWO_SIDED|95.0|0.24|1.1||Stratified analysis|Log Rank|||Pain in chest||1.10|0.24|0.0796
71797418|NCT02075840|143094481|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.6435|TWO_SIDED|95.0|0.72|1.68||Stratified analysis|Log Rank|||Composite score||1.68|0.72|0.6435
71797419|NCT00846742|143094488|SUPERIORITY|||||||0.0003||||||Comparison of proportion of patients' complete response rate between HOD99 (NCT number: NCT00145600) and HOD08|Exact Binominal Test|||The proportion of patients' complete response rate was provided with a 95% confidence interval.||||0.0003
71674030|NCT02582242|142866454|OTHER||Treatment difference at week 24|-0.09||||0.2601|TWO_SIDED|95.0|-0.23|0.06|||Mixed model for repeated measurements||Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID).|The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.||0.06|-0.23|0.2601
71674031|NCT00603902|142866472|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio, log|2.69|||<|0.0001|TWO_SIDED|95.0|2.31|3.13|||Regression, Logistic|Adjustments for baseline body weight.||||3.13|2.31|<0.0001
71674032|NCT00603902|142866473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.44|-2.56|||ANCOVA|||||-2.56|-3.44|<0.0001
71797420|NCT00846742|143094493|SUPERIORITY||Hazard Ratio (HR)|0.969||||0.732|TWO_SIDED|95.0|0.81|1.159|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure with a 1-year increase in age.|||1.159|0.810|0.732
71797421|NCT00846742|143094494|SUPERIORITY||Hazard Ratio (HR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing males to females.|Male vs. Female, with Female as the reference level||0.000|0.000|<0.001
71797422|NCT00846742|143094495|SUPERIORITY||Hazard Ratio (HR)|30101.41|||<|0.001|TWO_SIDED|95.0|3329.573|272135.5|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Stage IIA to Stage IA.|Stage IIA vs. Stage IA, with Stage IA as the reference level||272135.500|3329.573|<0.001
71797423|NCT00846742|143094496|SUPERIORITY||Hazard Ratio (HR)|34027.68|||<|0.001|TWO_SIDED|95.0|4072.872|284291.6|||Fine-Gray model||The sub-distribution hazard ratio for the 2-year cumulative incidence of local failure comparing Classical (all combined) to Nodular Lymphocyte Predominant Hodgkin Lymphoma.|Classical (all combined) vs. Nodular lymphocyte predominant, with Nodular lymphocyte predominant as the reference level||284291.600|4072.872|<0.001
71797424|NCT00846742|143094497|SUPERIORITY|||||||0.461|||||||Log Rank|||Comparing the 2-year EFS between HOD08 Participants and HOD99 Participants||||0.461
71840444|NCT04508309|143190100|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.25|||||TWO_SIDED|98.3|1.022|1.539|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||1.539|1.022|
71674033|NCT00459290|142866481|SUPERIORITY_OR_OTHER|||||||0.7912|||||||Log Rank|||||||0.7912
71674034|NCT00459290|142866482|SUPERIORITY_OR_OTHER|||||||0.1545|||||||Log Rank|||||||0.1545
71674035|NCT00459290|142866483|SUPERIORITY_OR_OTHER|||||||0.0648|||||||Log Rank|||||||0.0648
71797425|NCT00846742|143094497|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 Participants and HOD99 Participants||||1.000
71674036|NCT01134107|142866506|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.36|||||TWO_SIDED|95.0|0.06|0.66|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c|This was the primary gated analysis.||0.66|0.06|
71674037|NCT01134107|142866507|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.18|||||TWO_SIDED|95.0|-0.1|0.47|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c|||0.47|-0.10|
71797426|NCT00846742|143094497|SUPERIORITY|||||||0.836|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 Participants and HOD99 Participants||||0.836
71797427|NCT00846742|143094499|SUPERIORITY|||||||0.384|||||||Log Rank|||Comparing the 2-year EFS between HOD08 - CR and HOD99 - CR||||0.384
71797428|NCT00846742|143094499|SUPERIORITY|||||||1|||||||Log Rank|||Comparing the 2-year OS between HOD08 - CR and HOD99 - CR||||1.000
71797429|NCT00846742|143094499|SUPERIORITY|||||||0.386|||||||Gray's test|||Comparing the 2-year CI of Local Failure between HOD08 - CR and HOD99 - CR||||0.386
71797430|NCT00846742|143094500|SUPERIORITY|||||||0.986|||||||Log Rank|||Comparing the 2-year EFS of patients treated without and with RT||||0.986
71797431|NCT03909165|143094502|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.56|1.21||||||2 mg/kg AUC0-inf Geometric Mean Ratio (GMR) = Birth to 27 days AUC0-inf Geometric Mean (GM) / 28 days to \< 3 months AUC0-inf GM.||1.21|0.56|
71797432|NCT03909165|143094502|OTHER||Geometric Mean Ratio (GMR)|1.41|||||TWO_SIDED|90.0|1.0|1.98||||||2 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.98|1.00|
71797433|NCT03909165|143094502|OTHER||Geometric Mean Ratio (GMR)|0.82|||||TWO_SIDED|90.0|0.6|1.11||||||2 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.11|0.60|
71797434|NCT03909165|143094502|OTHER||Geometric Mean Ratio (GMR)|1.23|||||TWO_SIDED|90.0|0.96|1.56||||||4 mg/kg AUC0-inf GMR = Birth to 27 days AUC0-inf GM / 28 days to \< 3 months AUC0-inf GM.||1.56|0.96|
71797435|NCT03909165|143094502|OTHER||Geometric Mean Ratio (GMR)|1.29|||||TWO_SIDED|90.0|1.03|1.62||||||4 mg/kg AUC0-inf GMR = 28 days to \< 3 months AUC0-inf GM / 3 to \< 6 months AUC0-inf GM.||1.62|1.03|
71797436|NCT03909165|143094502|OTHER||Geometric Mean Ratio (GMR)|0.89|||||TWO_SIDED|90.0|0.7|1.13||||||4 mg/kg AUC0-inf GMR = 3 to \< 6 months AUC0-inf GM / 6 months to \< 2 years AUC0-inf GM.||1.13|0.70|
71797437|NCT03909165|143094503|OTHER||Geometric Mean Ratio (GMR)|0.91|||||TWO_SIDED|90.0|0.67|1.23||||||2 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.23|0.67|
71797438|NCT03909165|143094503|OTHER||Geometric Mean Ratio (GMR)|1.25|||||TWO_SIDED|90.0|0.92|1.69||||||2 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.69|0.92|
71797439|NCT03909165|143094503|OTHER||Geometric Mean Ratio (GMR)|0.83|||||TWO_SIDED|90.0|0.64|1.08||||||2 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.08|0.64|
71674038|NCT01134107|142866507|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.42|||||TWO_SIDED|95.0|0.25|0.58|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c|||0.58|0.25|
71840445|NCT04508309|143190100|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.68|||||TWO_SIDED|98.3|1.372|2.069|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.069|1.372|
71674039|NCT01134107|142866508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.38|||||TWO_SIDED|95.0|-0.13|0.88|||||Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.88|-0.13|
71674040|NCT01134107|142866508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|||||TWO_SIDED|95.0|-0.26|0.31|||||Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.31|-0.26|
71674041|NCT01134107|142866508|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.15|0.6|||||Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose|||0.60|-0.15|
71797440|NCT03909165|143094503|OTHER||Geometric Mean Ratio (GMR)|0.86|||||TWO_SIDED|90.0|0.7|1.06||||||4 mg/kg AUC0-1hr GMR = Birth to 27 days AUC0-1hr GM / 28 days to \< 3 months AUC0-1hr GM.||1.06|0.70|
71797441|NCT03909165|143094503|OTHER||Geometric Mean Ratio (GMR)|1.07|||||TWO_SIDED|90.0|0.89|1.29||||||4 mg/kg AUC0-1hr GMR = 28 days to \< 3 months AUC0-1hr GM / 3 to \< 6 months AUC0-1hr GM.||1.29|0.89|
71797442|NCT03909165|143094503|OTHER||Geometric Mean Ratio (GMR)|0.97|||||TWO_SIDED|90.0|0.8|1.17||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months AUC0-1hr GM / 6 months to \< 2 years AUC0-1hr GM.||1.17|0.80|
71674042|NCT01134107|142866509|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|0.08|0.24|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c|||0.24|0.08|
71797443|NCT03909165|143094505|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.61|1.4||||||2 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.40|0.61|
71674043|NCT01134107|142866510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.39|1.63|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.63|0.39|
71674044|NCT01134107|142866510|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36|||||TWO_SIDED|95.0|0.2|0.63|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||0.63|0.20|
71674045|NCT01134107|142866511|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose.|Crossover Model|||||||0.595
71797444|NCT03909165|143094505|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.7|1.7||||||2 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||1.70|0.70|
71797445|NCT03909165|143094505|OTHER||Geometric Mean Ratio (GMR)|0.92|||||TWO_SIDED|90.0|0.63|1.36||||||2 mg/kg Cmax GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.36|0.63|
71674046|NCT01134107|142866511|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose.|Crossover Model|||||||0.506
71674047|NCT01134107|142866511|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose.|Crossover Model|||||||0.790
71797446|NCT03909165|143094505|OTHER||Geometric Mean Ratio (GMR)|0.94|||||TWO_SIDED|90.0|0.7|1.26||||||4 mg/kg Cmax GMR = Birth to 27 days Cmax GM / 28 days to \< 3 months Cmax GM.||1.26|0.70|
71797447|NCT03909165|143094505|OTHER||Geometric Mean Ratio (GMR)|0.68|||||TWO_SIDED|90.0|0.52|0.89||||||4 mg/kg Cmax GMR = 28 days to \< 3 months Cmax GM / 3 to \< 6 months Cmax GM.||0.89|0.52|
71797448|NCT03909165|143094505|OTHER||Geometric Mean Ratio (GMR)|1.09|||||TWO_SIDED|90.0|0.83|1.43||||||4 mg/kg AUC0-1hr GMR = 3 to \< 6 months Cmax GM / 6 months to \< 2 years Cmax GM.||1.43|0.83|
71797449|NCT03909165|143094510|SUPERIORITY||Hazard Ratio (HR)|2.4|||=|0.0002|TWO_SIDED|95.0|1.37|4.18||Two-sided p-value based on log-rank test stratified by neuromuscular blocking agent and age groups.|Log Rank|||The Hazard Ratio (HR) for the pairwise comparison of Sugammadex 2 mg/kg vs. Neostigmine + (Glycopyrrolate or Atropine) was based on a Cox regression model with Efron's method of tie handling with covariates of treatment, age (continuous) and stratified by neuromuscular blocking agent.||4.18|1.37|= 0.0002
71797450|NCT03909165|143094511|OTHER||Difference in Percentage|7.6|||||TWO_SIDED|95.0|-14.2|29.5||||||The difference in percentage of participants with an AE in sugammadex 2 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||29.5|-14.2|
71797451|NCT03909165|143094511|OTHER||Difference in Percentage|5.9|||||TWO_SIDED|95.0|-13.5|26.7||||||The difference in percentage of participants with an AE in sugammadex 4 mg/kg group versus the Neostigmine + (Glycopyrrolate or Atropine) group was based on the Miettinen and Nurminen method stratified by neuromuscular blocking agent and age group.||26.7|-13.5|
71674048|NCT01134107|142866513|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||negative binomial test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||0.059
71797452|NCT03762083|143094564|OTHER|The clinical performance endpoint - Clinical cure rate on Day 7 - was calculated and presented together with a one-sided 95% CI based on the exact binomial distribution (Clopper-Pearson).|Clinical cure rate|81.9|||||ONE_SIDED|95.0|63.1|||||||"It was assumed that the true cure rate was equal to 70%, therefore 22 patients were needed to obtain 90% chance (90% power) to show that the one-sided 95% confidence interval (CI) for the observed cure rate was above 40%.~Hypotheses for the primary clinical performance endpoint:~* Null hypothesis: Clinical cure rate is less than or equal to 40%.~* Alternative hypothesis (one-sided): Clinical cure rate is above 40%."|||63.1|
71797453|NCT03762083|143094565|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 1.|85.7|||||TWO_SIDED|95.0|63.7|97.0||||||||97.0|63.7|
71797454|NCT03762083|143094566|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 2.|90.0|||||TWO_SIDED|95.0|68.3|98.8||||||||98.8|68.3|
71797455|NCT03762083|143094567|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Prop. negative for Amsel criterion 3.|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
71674049|NCT01134107|142866514|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||1.00
71797456|NCT03762083|143094569|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 14|5.6|||||TWO_SIDED|95.0|0.1|27.3||||||||27.3|0.1|
71797457|NCT03762083|143094569|OTHER|Results are based on the exact binomial distribution (Clopper-Pearson).|Recurrence rate Day 35|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0|
71797458|NCT04399161|143094575|SUPERIORITY|||||||0.123|||||||ANOVA|||Comparison among Children||||0.123
71797459|NCT04399161|143094575|SUPERIORITY|||||||0.314|||||||ANOVA|||Comparison among Elderly||||0.314
71840446|NCT04508309|143190100|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower bound of the 98.3% confidence interval of the geometric mean concentration (GMC) ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.71|||||TWO_SIDED|98.3|1.389|2.102|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|The primary objective included three non-inferiority comparisons of Cecolin at 0 and 6 months, 0 and 12 months, or 0 and 24 months compared to Gardasil at 0 and 6 months. To control the type I error for the three co-primary non-inferiority hypotheses, a Bonferroni correction corresponding to 98.3% confidence intervals (CI) was used.||2.102|1.389|
71674050|NCT01134107|142866514|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test|||||||0.472
71674051|NCT01134107|142866515|SUPERIORITY_OR_OTHER|||||||0.383||95.0||||P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.383
71797460|NCT02800148|143094610|EQUIVALENCE|provides 85% power of success|equivalence ratio|107.0|||||TWO_SIDED|90.0|96.1|115.5||No p-value as calculated for bioequivalence, just a T/R ratio and 90% confidence interval|Fieller's method|||||115.5|96.1|
71674052|NCT01134107|142866515|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test|||||||0.499
71840447|NCT04508309|143190105|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.75|||||TWO_SIDED|95.0|1.476|2.071|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||2.071|1.476|
71674053|NCT01134107|142866516|SUPERIORITY_OR_OTHER|||||||1||95.0||||The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test.|Gart's Test|Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation.||||||1.00
71674054|NCT01134107|142866517|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Negative Binomial Test|P-value computed using a negative binomial test including factors for treatment, period and sequence.||||||<0.001
71797461|NCT01455012|143094611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-160.34|STANDARD_ERROR_OF_MEAN|26.46|<|0.0001|TWO_SIDED|95.0|-213.23|-107.45||The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.|ANCOVA||The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.|The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).||-107.45|-213.23|<0.0001
71797462|NCT00739752|143094633|SUPERIORITY||Risk Ratio (RR)|0.99|||=|0.885|TWO_SIDED|95.0|0.88|1.12|||Regression, Poisson|||The two gain-framed groups were compared to the two loss-framed groups using poisson regression.||1.12|.88|=.885
71797463|NCT00739752|143094633|SUPERIORITY||Risk Ratio (RR)|1.17|||<|0.01|TWO_SIDED|95.0|1.06|1.31|||Regression, Poisson|||Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.||1.31|1.06|<.01
71797464|NCT00739752|143094633|SUPERIORITY||Risk Ratio (RR)|1.16|||<|0.01|TWO_SIDED|95.0|1.05|1.28|||Regression, Poisson|||The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.||1.28|1.05|<.01
71674055|NCT01134107|142866518|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Crossover Model|P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight||||||<0.001
71674056|NCT01134107|142866519|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure.|Crossover Model|||||||0.147
71797465|NCT01434290|143094634|SUPERIORITY|||||||0.19|||||||One sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.19
71797466|NCT01434290|143094634|SUPERIORITY|||||||0.08|||||||One sample z-test|one-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.08
71797467|NCT01434290|143094635|SUPERIORITY|||||||0.18|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.18
71797468|NCT01434290|143094635|SUPERIORITY|||||||0.38|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel \& urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.||||0.38
71797469|NCT01434290|143094640|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
71797470|NCT01434290|143094640|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[Bowel one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.03
71797471|NCT01434290|143094640|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.09
71797472|NCT01434290|143094640|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Two-side significance level of 0.017||\[Urinary one-year results\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.||||0.43
71797473|NCT01434290|143094641|SUPERIORITY|||||||0.39|||||||One-sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.39
71797474|NCT01434290|143094641|SUPERIORITY|||||||0.21|||||||One sample z-test|One-side significance level of 0.025||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.21
71797475|NCT01434290|143094642|SUPERIORITY|||||||0.44|||||||one sampe z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.44
71797476|NCT01434290|143094642|SUPERIORITY|||||||0.53|||||||One sample z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.||||0.53
71797477|NCT01434290|143094643|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.16
71674057|NCT01134107|142866519|SUPERIORITY_OR_OTHER|||||||0.894||95.0||||P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure.|Crossover Model|||||||0.894
71797478|NCT01434290|143094643|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year Index Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.03
71674058|NCT02362672|142866530|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0019|TWO_SIDED||||||z-test|||NKTR-181 (Double-blind Treatment Phase), Placebo (Double-blind Treatment Phase)||||0.0019
71674059|NCT02801617|142866544|NON_INFERIORITY|it will be considered not inferior if they keep the IOP goal with differences of no more than 2 mmHg analysis by protocol||||||0.861|||||||t-test, 2 sided|||||||0.861
71674060|NCT02801617|142866544|NON_INFERIORITY|it will be considered not inferior if they keep the TIOP with differences of no more than 2 mmHg||||||0.89|||||||t-test, 2 sided|||||||0.890
71674061|NCT02801617|142866545|NON_INFERIORITY|intention-to-treat analysis (ITT)||||||0.329|||||||Chi-squared|||||||0.329
71840448|NCT04508309|143190106|NON_INFERIORITY|Non-inferiority of the Cecolin containing arm (Group 5) compared to Gardasil at months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.21|||||TWO_SIDED|95.0|1.004|1.451|||||GMC ratio (Cecolin containing arm (Group 5)/Gardasil (Group 4)) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.451|1.004|
71840449|NCT04508309|143190107|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.933|1.344|||||GMC ratio (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.344|0.933|
71840450|NCT04508309|143190108|NON_INFERIORITY|Non-inferiority of Cecolin at Months 0 and 6 (Group 1) compared to Gardasil at Months 0 and 6 (Group 4) was to be demonstrated if the lower limit of the 95% CI of the GMC ratio was greater than the non-inferiority margin of 0.5 for both HPV-16 and HPV-18.|GMC Ratio|1.32|||||TWO_SIDED|95.0|1.07|1.635|||||GMC ratios (Cecolin/Gardasil) and corresponding confidence limits were calculated using linear models of the log concentration values adjusted by site and transformed back to the original scale.|||1.635|1.070|
71840451|NCT05196919|143190138|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|8.693||1|TWO_SIDED|95.0|-22.57|30.97|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||30.97|-22.57|1.00
71797479|NCT01434290|143094643|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.83
71797480|NCT01434290|143094643|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||\[One-year VAS Score\] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.||||0.86
71797481|NCT01806896|143094660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.68||0.68|TWO_SIDED|90.0|-3.56|2.15||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effects and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Day 28)||2.15|-3.56|0.68
71797482|NCT01806896|143094662|SUPERIORITY_OR_OTHER||Least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.79|TWO_SIDED|90.0|-0.72|0.52||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Left VS)||0.52|-0.72|0.79
71797483|NCT01806896|143094662|SUPERIORITY_OR_OTHER||Least square mean|-0.15|STANDARD_ERROR_OF_MEAN|0.37||0.7|TWO_SIDED|90.0|-0.8|0.51||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew\>Neut Right VS)||0.51|-0.80|0.70
71797484|NCT01806896|143094662|SUPERIORITY_OR_OTHER||Least square mean|-0.25|STANDARD_ERROR_OF_MEAN|0.37||0.51|TWO_SIDED|90.0|-0.89|0.4||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Left VS)||0.40|-0.89|0.51
71840452|NCT05196919|143190138|SUPERIORITY||Mean Difference (Final Values)|7.96|STANDARD_ERROR_OF_MEAN|8.142||0.99|TWO_SIDED|95.0|-17.12|33.03|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||33.03|-17.12|0.99
71840453|NCT05196919|143190139|SUPERIORITY||Mean Difference (Final Values)|-6.15|STANDARD_ERROR_OF_MEAN|4.676||0.1933|TWO_SIDED|95.0|-15.49|3.19|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||3.19|-15.49|0.1933
71840454|NCT05196919|143190139|SUPERIORITY||Mean Difference (Final Values)|5.14|STANDARD_ERROR_OF_MEAN|4.434||0.2511|TWO_SIDED|95.0|-3.73|14.0|||Mixed Models Analysis|||This was a phase 2a safety study that was not statistically powered for efficacy assessments.||14.00|-3.73|0.2511
71840455|NCT03621371|143190142|OTHER||F-test|9.88|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71840456|NCT01658930|143190170|NON_INFERIORITY|Margin of inferiority in the difference of 3 year pelvic recurrence rates between simple and radical hysterectomy group was 4%.|Mean Difference (Final Values)|0.0035|||||TWO_SIDED|90.0|-0.0162|0.0232|||||Difference between simple and radical hysterectomy groups.|||0.0232|-0.0162|
71840457|NCT01658930|143190171|SUPERIORITY||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.47|2.67|||||Hazard ratio of simple to radical hysterectomy.|||2.67|0.47|
71674062|NCT02801617|142866546|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.388|||||||Chi-squared, Corrected|||||||0.388
71674063|NCT02801617|142866547|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.125|||||||Chi-squared, Corrected|||||||0.125
71797485|NCT01806896|143094662|SUPERIORITY_OR_OTHER||Least square mean|-0.53|STANDARD_ERROR_OF_MEAN|0.33||0.13|TWO_SIDED|90.0|-1.1|0.04||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out\_win\_Rew\>Out\_win N Right VS)||0.04|-1.10|0.13
71674064|NCT02801617|142866548|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.434|||||||Chi-squared, Corrected|||||||0.434
71797486|NCT01806896|143094665|SUPERIORITY_OR_OTHER||Least square mean|7.3|STANDARD_ERROR_OF_MEAN|3.57||0.04|TWO_SIDED|90.0|1.43|13.18||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Neutral) Day 28||13.18|1.43|0.04
71797487|NCT01806896|143094665|SUPERIORITY_OR_OTHER||Least square mean|7.57|STANDARD_ERROR_OF_MEAN|3.57||0.03|TWO_SIDED|90.0|1.69|13.45||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28||13.45|1.69|0.03
71674065|NCT02801617|142866549|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0|||||||Chi-squared, Corrected|||||||0
71674066|NCT02801617|142866550|NON_INFERIORITY|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.039|||||||Chi-squared|||||||0.039
71797488|NCT01806896|143094665|SUPERIORITY_OR_OTHER||Least square mean|7.28|STANDARD_ERROR_OF_MEAN|3.56||0.04|TWO_SIDED|90.0|1.41|13.15||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28||13.15|1.41|0.04
71797489|NCT01806896|143094665|SUPERIORITY_OR_OTHER||Least square mean|0.98|STANDARD_ERROR_OF_MEAN|3.58||0.78|TWO_SIDED|90.0|-4.91|6.87||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28||6.87|-4.91|0.78
71797490|NCT01806896|143094665|SUPERIORITY_OR_OTHER||Least square mean|4.78|STANDARD_ERROR_OF_MEAN|3.58||0.18|TWO_SIDED|90.0|-1.11|10.67||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28||10.67|-1.11|0.18
71797491|NCT01806896|143094665|SUPERIORITY_OR_OTHER||Least square mean|16.35|STANDARD_ERROR_OF_MEAN|3.58|<|0.01|TWO_SIDED|90.0|10.46|22.24||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment\*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28||22.24|10.46|<0.01
71797492|NCT02434770|143094668|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.84|||||TWO_SIDED|95.0|0.65|1.08|||||Lot 1 / Lot 2|||1.08|0.65|
71797493|NCT02434770|143094668|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.08|||||TWO_SIDED|95.0|0.87|1.34|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.34|0.87|
71797494|NCT02434770|143094669|EQUIVALENCE|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.92|||||TWO_SIDED|95.0|0.73|1.15|||||Lot 1 / Lot 2|||1.15|0.73|
71797495|NCT02434770|143094669|NON_INFERIORITY|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was \> 0.5.|Ratio of Geometric Mean Titers|1.47|||||TWO_SIDED|95.0|1.21|1.79|||||BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV|||1.79|1.21|
71797496|NCT02434770|143094670|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|1.5|||||TWO_SIDED|95.0|-0.5|4.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For serotype 1||4.6|-0.5|
71674067|NCT06110494|142866573|OTHER|Pairwise comparisons were done using Mann-Whitney U test of log10 transformed CFU reduction data to compare the antimicrobial effectiveness.||||||0.05||||||Pairwise comparisons were done using Mann-Whitney U test of log 10 transformed data to compare the antimicrobial effectiveness of Fer/H2O2 in comparison with the negative (saline) and positive (NaOCl) controls with P values set at \< 0.05|Wilcoxon (Mann-Whitney)|||The sample size estimate was calculated in Pass Software 2021, using a test that compares the ratio of two means from independent samples using data that has been log-normalized. An alpha of 0.05 and power of 80% was assumed, with means and standard deviations pulled from previous studies that employed similar methodology. This produced a required sample size of 16 for each group. Pairwise comparisons were done using Mann-Whitney U test to compare the antimicrobial effectiveness.||||0.05
71674068|NCT00676364|142866617|NON_INFERIORITY_OR_EQUIVALENCE|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|Mean Difference (Final Values)|2.1||||0.71|||||||Chi-squared||To assess the association between pain and anxiety with intervention group while controlling for other factors, linear regression was used.|P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.||||0.71
71840458|NCT01658930|143190172|SUPERIORITY||Hazard Ratio (HR)|3.82|||||TWO_SIDED|95.0|0.79|18.4|||||Hazard ratio is simple hysterectomy group of radical hysterectomy group.|||18.4|0.79|
71840459|NCT01658930|143190173|SUPERIORITY||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.69|3.45|||||Hazard ratio is simple hysterectomy group to radical hysterectomy group.|||3.45|0.69|
71674069|NCT01422889|142866628|SUPERIORITY_OR_OTHER||percentage|2.2|||||TWO_SIDED|||||A p-value was not calculated for the ION Registry 12 month cardiac events. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months||||
71674070|NCT01422889|142866629|SUPERIORITY_OR_OTHER||percentage|2.6|||||ONE_SIDED|||||A p-value was not calculated for the ION Registry 2 year cardiac events. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.||||2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.||||
71674071|NCT01303172|142866657|OTHER||Cox Proportional Hazard|0.54||||0.011|TWO_SIDED|95.0|0.33|0.87|||Log Rank|||The difference between the two treatment groups was tested with a two-sided log-rank test and a Cox regression model was used to estimate the hazard ratio (HR) and its 95% CI and associated p-value.||0.87|0.33|0.011
71674072|NCT04468347|142866671|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||<0.0001
71674073|NCT04468347|142866671|OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.038||0.0005|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.0005
71797497|NCT02434770|143094670|NON_INFERIORITY|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|2.2|||||TWO_SIDED|95.0|-0.1|5.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For Serotype 3||5.6|-0.1|
71797498|NCT02434770|143094670|OTHER|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|-0.4|||||TWO_SIDED|95.0|-3.0|2.1|||||Lot 1 - Lot 2|For Serotype 1||2.1|-3.0|
71797499|NCT02434770|143094670|NON_INFERIORITY|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|0.1|||||TWO_SIDED|95.0|-2.6|2.8|||||Lot 1 - Lot 2|For Serotype 3||2.8|-2.6|
71797500|NCT02434770|143094671|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|1.2|||||TWO_SIDED|95.0|0.89|1.63|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.63|0.89|
71797501|NCT02434770|143094672|OTHER||Difference in seroprotection rate|-0.09||||0.5586|TWO_SIDED|95.0|-3.86|4.48|||Fisher's exact 1-tailed test|Fisher's exact 1-tailed test of a lower rate in Lots 1+2|BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|||4.48|-3.86|0.5586
71797502|NCT02434770|143094673|NON_INFERIORITY|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be \> 0.5.|Ratio of Geometric Mean Titers|0.99|||||TWO_SIDED|95.0|0.71|1.38|||||Lot 1 + Lot 2 / BioFarma bOPV|||1.38|0.71|
71797503|NCT00245765|143094674|SUPERIORITY||Odds Ratio (OR)|40.2|||<|0.001|TWO_SIDED|95.0|13.7|150.3|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||150.3|13.7|<0.001
71674074|NCT04468347|142866671|OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.033||0.2161|TWO_SIDED||||||ANOVA|The two-way ANOVA included cognitive and amyloid status, and their interaction as fixed effects.||||||0.2161
71674075|NCT04468347|142866672|OTHER|||||||0.1998|||||||Cochran-Mantel-Haenszel|||||||0.1998
71674076|NCT04468347|142866673|OTHER|||||||0.0646|||||||Cochran-Mantel-Haenszel|||||||0.0646
71674077|NCT00554515|142866674|SUPERIORITY|Comparison against historical control ORR of 14%.||||||0.042|||||||exact binomial test|||||||0.042
71797504|NCT00245765|143094674|SUPERIORITY||Odds Ratio (OR)|73.4|||<|0.001|TWO_SIDED|95.0|23.5|292.6|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||292.6|23.5|<0.001
71797505|NCT00245765|143094675|SUPERIORITY||Odds Ratio (OR)|64.1|||<|0.001|TWO_SIDED|95.0|12.7|1169.1|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.||||1169.1|12.7|<0.001
71797506|NCT00245765|143094675|SUPERIORITY||Odds Ratio (OR)|162.6|||<|0.001|TWO_SIDED|95.0|31.4|2999.2|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.|||2999.2|31.4|<0.001
71674078|NCT00554515|142866675|SUPERIORITY|||||||0.39|||||||Fisher Exact|||Objective response rates were compared between ISM good and poor risk subgroups. ISM good risk ORR reported under primary endpoint.||||0.39
71674079|NCT00554515|142866676|SUPERIORITY|||||||0.0014|||||||exact binomial test|||Test against the historical ORR was conducted in the overall study population as secondary analyses.||||0.0014
71797507|NCT01966926|143094707|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|chi square|2.05||||0.15|TWO_SIDED|||||P-value was unadjusted, with an a priori threshold for statistical significance set at p \<.05.|Chi-squared|1 degree of freedom||||||.15
71674080|NCT00554515|142866679|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between MSKCC subgroups.||||.89
71674081|NCT00554515|142866681|SUPERIORITY|||||||0.33|||||||Fisher Exact|||Objective response rates were compared between tumor type subgroups||||.33
71797508|NCT01966926|143094708|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.96||||0.61||||||P-value not adjusted for multiple comparisons; a priori threshold of \<0.05 for statistical significance|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.61
71797509|NCT01966926|143094709|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.95||||0.5||||||P-value is unadjusted; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.50
71797510|NCT01966926|143094710|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.87||||0.15||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.||||0.15
71797511|NCT01966926|143094711|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.91||||0.3||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 2,26||Repeated measures analysis from baseline to six months.||||0.30
71797512|NCT01966926|143094712|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.93||||0.17||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was \<0.05.|MANOVA|Degrees of freedom: 1,28||Repeated measures analysis from three to six months.||||0.17
71797513|NCT04074317|143094713|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001||||||Least-squares geometric means for ln-transformed data.|ANOVA|||||||<0.0001
71797514|NCT04074317|143094713|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.||||||0.694|||||||ANOVA|||||||0.694
71797515|NCT04074317|143094713|EQUIVALENCE|Treatment groups were compared using an analysis of variance (ANOVA) model, including sequence, period, and treatment as fixed effects and patient within sequence as random effect.|||||<|0.0001|||||||ANOVA|||||||<0.0001
71797516|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-21.29||||0.041|TWO_SIDED|95.0|-41.23|-1.36|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||-1.36|-41.23|0.041
71797517|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups.|LS Mean Difference|-7.45||||0.453|TWO_SIDED|95.0|-31.43|16.54|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||16.54|-31.43|0.453
71797518|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|13.85||||0.161|TWO_SIDED|95.0|-8.46|36.15|||ANOVA|||Plasma Glucose Levels: \>180 mg/dL: 0 to 90 minutes||36.15|-8.46|0.161
71797519|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-23.93|||<|0.001|TWO_SIDED|95.0|-35.37|-12.48|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||-12.48|-35.37|<0.001
71797520|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|3.1||||0.564|TWO_SIDED|95.0|-7.8|14.0|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||14.00|-7.80|0.564
71797521|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|27.03|||<|0.001|TWO_SIDED|95.0|15.96|38.09|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 180 minutes||38.09|15.96|<0.001
71840460|NCT01658930|143190174|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.38|3.14|||||Hazard ratio of simple to radical hysterectomy.|||3.14|0.38|
71840461|NCT02589795|143190258|OTHER|Inequality test|||||>|0.05|||||||Fisher Exact|||The proportions of subjects with primary safety outcomes were compared in a pairwise manner between the three randomised groups, using Fisher's exact tests.||||>0.05
71797522|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|-1.74||||0.813|TWO_SIDED|95.0|-16.7|13.22|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||13.22|-16.70|0.813
71674082|NCT00554515|142866682|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between clear cell histology subgroups||||.89
71674083|NCT00554515|142866683|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Objective response rates were compared between CA-9 score subgroups||||.19
71797523|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|2.35||||0.73|TWO_SIDED|95.0|-11.47|16.17|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||16.17|-11.47|0.730
71797524|NCT04074317|143094714|EQUIVALENCE|H0: Means are equal between treatment groups. Ha: means are not equal across the treatment groups.|LS Mean Difference|4.09||||0.582|TWO_SIDED|95.0|-10.97|19.15|||ANOVA|||Plasma Glucose \>180 mg/dL: 0 to 360 minutes||19.15|-10.97|0.582
71797525|NCT04074317|143094720|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80-125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|37.04|||<|0.0001|TWO_SIDED|90.0|31.36|43.75||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||43.75|31.36|<0.0001
71840462|NCT02589795|143190259|OTHER|Inequality test|||||>|0.05|||||||Kruskal-Wallis|Kruskal-Wallis test with Dunn's correction for multiple comparisons||Kruskal-Wallis test with Dunn's correction for multiple comparisons to compare the levels of antigen-specific serum IgG in the three groups at Week 22.||||>0.05
71797526|NCT04074317|143094721|OTHER||Ratio of least-square means|435.96|||<|0.0001|TWO_SIDED|||||Results of the statistical evaluation of ANOVA (alpha = 0.05) for the hypothesis of equal treatment effects.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||<0.0001
71797527|NCT04074317|143094722|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|60.44||||0.0075|TWO_SIDED|90.0|45.41|80.43||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.43|45.41|0.0075
71797528|NCT04074317|143094722|EQUIVALENCE|"Bioequivalence would require 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|93.32||||0.6773|TWO_SIDED|90.0|70.14|124.16||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA|Based on Least-Squares geometric means for ln-transformed data.|"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||124.16|70.14|0.6773
71674084|NCT00554515|142866684|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Objective response rates were compared between PD-L1 tumor subgroups||||0.01
71674085|NCT00554515|142866685|SUPERIORITY|||||||0.08|||||||Fisher Exact|||Objective response rates were compared between B7-H3 tumor subgroups||||.08
71674086|NCT00554515|142866686|SUPERIORITY|||||||0.28|||||||Fisher Exact|||Objective response rates were compared between CA-9 SNP subgroups||||.28
71674087|NCT00665431|142866689|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority margin (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.94|3.34|||ANCOVA|||||3.34|-5.94|
71797529|NCT04074317|143094722|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|97.43||||0.8768|TWO_SIDED|90.0|72.94|130.14||Results of the statistical evaluation of ANOVA (alpha=0.05) for the hypothesis of equal treatment effects.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||130.14|72.94|0.8768
71797530|NCT04074317|143094723|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.83|||<|0.0001|TWO_SIDED|90.0|44.51|65.11||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was ana analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||65.11|44.51|<0.0001
71797531|NCT04074317|143094723|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|73.16||||0.0192|TWO_SIDED|90.0|61.06|87.67||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||87.67|61.06|0.0192
71840463|NCT04909801|143190266|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||||1.6|0.6|0.9026
71674088|NCT00665431|142866690|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-2.11|||||TWO_SIDED|95.0|-6.82|2.6|||ANCOVA|||||2.60|-6.82|
71674089|NCT00665431|142866691|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|3.45|||||TWO_SIDED|95.0|-1.41|8.31|||ANCOVA|||||8.31|-1.41|
71674090|NCT01329380|142866705|OTHER|||||||0.0328|||||||Mann-Whitney U-test|||Age||||0.0328
71674091|NCT01329380|142866705|OTHER|||||||0.7128|||||||Fisher Exact|||Sex||||0.7128
71674092|NCT01329380|142866705|OTHER|||||||0.0465|||||||Mann-Whitney U-test|||Body mass index||||0.0465
71674093|NCT01329380|142866705|OTHER|||||||0.8872|||||||Mann-Whitney U-test|||Duration of illness||||0.8872
71674094|NCT01329380|142866705|OTHER|||||||0.0388|||||||Fisher Exact|||Smoking history||||0.0388
71674095|NCT01329380|142866705|OTHER|||||||0.4855|||||||Fisher Exact|||Complications||||0.4855
71674096|NCT01329380|142866705|OTHER|||||||0.663|||||||Fisher Exact|||Complications - Liver disorder||||0.6630
71674097|NCT01329380|142866705|OTHER|||||||0.2067|||||||Fisher Exact|||Complications - Renal disorder||||0.2067
71674098|NCT01329380|142866705|OTHER|||||||0.8749|||||||Fisher Exact|||Complications - Cardiovascular disorder||||0.8749
71674099|NCT01329380|142866705|OTHER|||||||0.482|||||||Fisher Exact|||Complications - Blood disorder||||0.4820
71797532|NCT04074317|143094723|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|135.91||||0.0244|TWO_SIDED|90.0|113.1|163.31||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||163.31|113.10|0.0244
71797533|NCT04074317|143094724|OTHER||Ratio of least-square means|73.53||||0.2541|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.2541
71797534|NCT04074317|143094724|OTHER||Ratio of least-squares means|103.89|||>|0.9999|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as PRAM least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||>0.9999
71797535|NCT04074317|143094724|OTHER||Ratio of least-square means|141.29||||0.1747|TWO_SIDED|||||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||Ratio calculated as Regular Insulin least-squares mean divided by the Regular Insulin + Pramlintide least-squares mean, expressed as a percentage.|The statistical model was an analysis of variance (ANOVA) with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||||0.1747
71674100|NCT01329380|142866705|OTHER|||||||0.6355|||||||Fisher Exact|||Complications - Respiratory disorder||||0.6355
71797536|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|53.16|||<|0.0001|TWO_SIDED|90.0|43.59|64.83||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||64.83|43.59|<0.0001
71797537|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|65.24||||0.0018|TWO_SIDED|90.0|54.02|78.8||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||78.80|54.02|0.0018
71797538|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|122.73||||0.2391|TWO_SIDED|90.0|101.33|148.66||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 90 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||148.66|101.33|0.2391
71797539|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|54.2|||<|0.0001|TWO_SIDED|90.0|47.58|61.73||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||61.73|47.58|<0.0001
71797540|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|71.29||||0.0002|TWO_SIDED|90.0|62.99|80.69||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||80.69|62.99|0.0002
71840464|NCT04909801|143190267|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.5824
71674101|NCT01329380|142866705|OTHER|||||||0.8193|||||||Fisher Exact|||Complications - Diabetes mellitus||||0.8193
71674102|NCT01329380|142866705|OTHER|||||||0.5723|||||||Fisher Exact|||Complications - Uveitis||||0.5723
71674103|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||Complications - Inflammatory bowel disease||||1.0000
71797541|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|131.55||||0.0026|TWO_SIDED|90.0|116.01|149.17||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 180 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||149.17|116.01|0.0026
71797542|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|51.34|||<|0.0001|TWO_SIDED|90.0|46.74|56.39||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||56.39|46.74|<0.0001
71840465|NCT04909801|143190268|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534||95.0|0.5|1.3|||Regression, Logistic|||||1.3|0.5|0.3534
71840466|NCT04909801|143190269|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||||1.5|0.5|0.6140
71840467|NCT04909801|143190271|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4996|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 29||1.4|0.5|0.4996
71840468|NCT04909801|143190271|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.449|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4490
71893391|NCT01642212|143307819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4963|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of regurgitation||||0.4963
71893392|NCT01642212|143307819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5257|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of abdominal pain||||0.5257
71813349|NCT02709005|143129189|SUPERIORITY||Risk Difference (RD)|-0.09||||0.035|TWO_SIDED|95.0|-0.24|-0.01||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||-0.01|-0.24|0.035
71893393|NCT01642212|143307819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of nausea||||0.5219
71840469|NCT04909801|143190271|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.809|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 85||1.7|0.5|0.8090
71840470|NCT04909801|143190271|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.9||||0.0739|TWO_SIDED|95.0|0.9|3.6|||Regression, Logistic|||Day 113||3.6|0.9|0.0739
71840471|NCT04909801|143190271|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.4201|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 141||2.6|0.7|0.4201
71840472|NCT04909801|143190271|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7928|TWO_SIDED|95.0|0.6|2.0|||Regression, Logistic|||Day 169||2.0|0.6|0.7928
71840473|NCT04909801|143190272|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2701|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 29||1.3|0.4|0.2701
71840474|NCT04909801|143190272|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4863|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 57||1.4|0.5|0.4863
71840475|NCT04909801|143190272|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9513|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.9513
71840476|NCT04909801|143190272|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8536|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 113||1.8|0.6|0.8536
71840477|NCT04909801|143190272|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9223|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 141||1.7|0.6|0.9223
71674104|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||Complications - Psoriasis||||1.0000
71840478|NCT04909801|143190272|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.6|||Regression, Logistic|||Day 169||1.6|0.6|0.9026
71840479|NCT04909801|143190273|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.3411|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||Day 29||1.6|0.2|0.3411
71840480|NCT04909801|143190273|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2546|TWO_SIDED|95.0|0.4|1.3|||Regression, Logistic|||Day 57||1.3|0.4|0.2546
71840481|NCT04909801|143190273|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4558|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 85||1.4|0.5|0.4558
71840482|NCT04909801|143190273|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9544|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 113||1.7|0.6|0.9544
71840483|NCT04909801|143190273|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.545|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 141||1.4|0.5|0.5450
71840484|NCT04909801|143190273|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.2227|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 169||1.2|0.4|0.2227
71674105|NCT01329380|142866705|OTHER|||||||0.0144|||||||Fisher Exact|||Past Illnesses||||0.0144
71674106|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||Allergy history||||1.0000
71674107|NCT01329380|142866705|OTHER|||||||0.3928|||||||Fisher Exact|||Adalimumab self-injection status||||0.3928
71674108|NCT01329380|142866705|OTHER|||||||0.2735|||||||Fisher Exact|||Prior medications - NSAIDs||||0.2735
71674109|NCT01329380|142866705|OTHER|||||||0.8875|||||||Fisher Exact|||Prior medications - Biological products||||0.8875
71674110|NCT01329380|142866705|OTHER|||||||0.254|||||||Fisher Exact|||Prior medications - Adrenal corticosteroids||||0.2540
71674111|NCT01329380|142866705|OTHER|||||||0.0226|||||||Fisher Exact|||Concomitant drugs||||0.0226
71674112|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||Concomitant drug: NSAIDs||||1.0000
71840485|NCT04909801|143190274|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.32|TWO_SIDED|95.0|0.3|1.4|||Regression, Logistic|||Day 29||1.4|0.3|0.3200
71674113|NCT01329380|142866705|OTHER|||||||0.2481|||||||Fisher Exact|||Concomitant drugs - DMARDs||||0.2481
71674114|NCT01329380|142866705|OTHER|||||||0.1558|||||||Fisher Exact|||Concomitant drugs - Methotrexate||||0.1558
71674115|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||Concomitant drugs - salazosulfapyridine||||1.0000
71674116|NCT01329380|142866705|OTHER|||||||0.0094|||||||Fisher Exact|||Concomitant drugs - Adrenal corticosteroids||||0.0094
71674117|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||Concomitant therapy||||1.0000
71674118|NCT01329380|142866705|OTHER|||||||0.8836|||||||Fisher Exact|||Human leukocyte antigen B27 (HLA-B27) test result||||0.8836
71674119|NCT01329380|142866705|OTHER|||||||1|||||||Fisher Exact|||BASDAI at start of treatment||||1.0000
71674120|NCT01294241|142866725|SUPERIORITY_OR_OTHER||||||=|0.008||||||Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|Two-sided exact binomial test|||The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0||||=0.008
71674121|NCT01294241|142866726|SUPERIORITY_OR_OTHER||||||=|0.21||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||=0.21
71674122|NCT01294241|142866727|SUPERIORITY_OR_OTHER|||||||0.33||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.||||0.33
71674123|NCT02748213|142866737|SUPERIORITY_OR_OTHER||Difference in Response Rates|2.2||||0.717|TWO_SIDED|95.0|-10.17|14.56|||Chi-squared||The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.|||14.56|-10.17|0.717
71674124|NCT02748213|142866739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0449|TWO_SIDED|95.0|0.53|0.99|||Log Rank||Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.|||0.99|0.53|0.0449
71674125|NCT02748213|142866741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.4758|TWO_SIDED|95.0|0.56|1.32|||Log Rank||HR calculated using Herceptin + Taxotere arm as reference.|||1.32|0.56|0.4758
71674126|NCT03291431|142866768|OTHER|Chi-Square comparison of frequencies|Pearson Chi-Square|0.17||||0.99|TWO_SIDED|||||A p-value of \<0.05 is considered statistically significant.|Chi-squared|||||||0.99
71674127|NCT03291431|142866769|OTHER||Slope|-0.2||||0.68|TWO_SIDED|95.0||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|Linear mixed modeling||||0.68
71674128|NCT03291431|142866770|OTHER|||||||0.34||||||p-value \< .05 considered statistically significant.|Mixed Models Analysis|||||||0.34
71674129|NCT03291431|142866771|OTHER|Linear mixed modeling|Slope|-1.99||||0.7|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis||Rate of change compared between groups using linear mixed modeling.|||||0.70
71674130|NCT03291431|142866772|OTHER||Slope|0.3||||0.11|TWO_SIDED|||||p \< .05 considered statistically significant.|Mixed Models Analysis|||Linear mixed modeling||||0.11
71674131|NCT00550745|142866780|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||||95.0|0.91|1.73|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 42 Days postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.73|0.91|
71674132|NCT00550745|142866781|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||||95.0|0.98|1.32|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 6 months postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen \[Comparative analysis of two rates. Stat Med 1985;4:213-26\] method.|||1.32|0.98|
71674133|NCT02498444|142866791|OTHER||Risk Ratio (RR)|1.29||||0.03|TWO_SIDED|95.0|1.02|1.64|||Poisson regression|Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)||||1.64|1.02|0.03
71674134|NCT02498444|142866792|OTHER||Risk Ratio (RR)|1.23||||0.0498|TWO_SIDED|95.0|1.0|1.51||Poisson regression model demonstrating associations between treatment groups and outcomes (chest tube duration in days and length of stay in days)|Poisson regression|||||1.51|1.00|0.0498
71674135|NCT02498444|142866793|OTHER|||||||0.05|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.05
71674136|NCT02498444|142866793|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
71840486|NCT04909801|143190274|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4992|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.4992
71840487|NCT04909801|143190274|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8963|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 85||1.7|0.6|0.8963
71840488|NCT04909801|143190274|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4544|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|||Day 113||1.4|0.5|0.4544
71840489|NCT04909801|143190274|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.8985|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Day 141||1.8|0.6|0.8985
71840490|NCT04909801|143190274|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5824|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.5824
71797543|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|78.24||||0.0003|TWO_SIDED|90.0|71.39|85.76||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as PRAM geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||85.76|71.39|0.0003
71797544|NCT04074317|143094725|EQUIVALENCE|"Bioequivalence would require the 90% confidence intervals of the geometric mean ratio to be contained within the 80 - 125% range.~H0: Means are equal between treatment groups. Ha: Means are not equal across the treatment groups."|Ratio of geometric least-squares means|152.41|||<|0.0001|TWO_SIDED|90.0|138.91|167.22||Bonferroni-adjusted p-value to maintain the overall Type 1 error rate at 0.05.|ANOVA||"Ratio calculated as Regular Insulin geometric least-squares mean divided by the Regular Insulin + Pramlintide geometric least-squares mean, expressed as a percentage.~Confidence interval on the ratio, expressed as a percentage."|AUC 0 to 360 The statistical model was an analysis of variance (ANOVA) on the ln-transformed data with sequence, period, and treatment as fixed effect and subject nested within sequence as a random effect.||167.22|138.91|<0.0001
71797545|NCT03548584|143094726|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-1.87|-8.77|0.0026
71797546|NCT03548584|143094727|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||||-0.07|-0.47|0.0078
71797547|NCT03548584|143094728|SUPERIORITY||LS Mean Difference|-1.95||||0.004|TWO_SIDED|95.0|-3.28|-0.63||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Aggressive Behavior||-0.63|-3.28|0.0040
71797548|NCT03548584|143094728|SUPERIORITY||LS Mean Difference|-1.41||||0.0296|TWO_SIDED|95.0|-2.68|-0.14||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Physically Nonaggressive Behavior||-0.14|-2.68|0.0296
71797549|NCT03548584|143094728|SUPERIORITY||LS Mean Difference|-1.24||||0.0113|TWO_SIDED|95.0|-2.21|-0.28||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Verbally Agitated Behavior||-0.28|-2.21|0.0113
71797550|NCT03548584|143094728|SUPERIORITY||LS Mean Difference|-0.36||||0.1941|TWO_SIDED|95.0|-0.9|0.18||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Hiding and Hoarding||0.18|-0.90|0.1941
71797551|NCT03548584|143094729|SUPERIORITY||LS Mean Difference|0.85||||0.4242|TWO_SIDED|95.0|-1.24|2.93||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 2||2.93|-1.24|0.4242
71797552|NCT03548584|143094729|SUPERIORITY||LS Mean Difference|-1.14||||0.3665|TWO_SIDED|95.0|-3.63|1.34||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change From Baseline at Week 4||1.34|-3.63|0.3665
71797553|NCT03548584|143094729|SUPERIORITY||LS Mean Difference|-2.32||||0.1065|TWO_SIDED|95.0|-5.15|0.5||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.50|-5.15|0.1065
71797554|NCT03548584|143094729|SUPERIORITY||LS Mean Difference|-5.08||||0.0011|TWO_SIDED|95.0|-8.12|-2.05||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-2.05|-8.12|0.0011
71797555|NCT03548584|143094729|SUPERIORITY||LS Mean Difference|-6.47|||<|0.0001|TWO_SIDED|95.0|-9.54|-3.4||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-3.40|-9.54|<.0001
71840491|NCT04909801|143190275|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.4152|TWO_SIDED|95.0|0.6|4.1|||Regression, Logistic|||Day 29||4.1|0.6|0.4152
71797556|NCT03548584|143094729|SUPERIORITY||LS Mean Difference|-5.32||||0.0026|TWO_SIDED|95.0|-8.77|-1.87||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-1.87|-8.77|0.0026
71797557|NCT03548584|143094730|SUPERIORITY||LS Mean Difference|0.05||||0.3048|TWO_SIDED|95.0|-0.05|0.16||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 2||0.16|-0.05|0.3048
71797558|NCT03548584|143094730|SUPERIORITY||LS Mean Difference|-0.03||||0.7058|TWO_SIDED|95.0|-0.17|0.12||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 4||0.12|-0.17|0.7058
71797559|NCT03548584|143094730|SUPERIORITY||LS Mean Difference|-0.06||||0.4516|TWO_SIDED|95.0|-0.23|0.1||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 6||0.10|-0.23|0.4516
71840492|NCT04909801|143190275|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5917|TWO_SIDED|95.0|0.6|2.5|||Regression, Logistic|||Day 57||2.5|0.6|0.5917
71797560|NCT03548584|143094730|SUPERIORITY||LS Mean Difference|-0.27||||0.0052|TWO_SIDED|95.0|-0.46|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 8||-0.08|-0.46|0.0052
71840493|NCT04909801|143190275|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.4||||0.3348|TWO_SIDED|95.0|0.7|2.6|||Regression, Logistic|||Day 85||2.6|0.7|0.3348
71840494|NCT04909801|143190275|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3959|TWO_SIDED|95.0|0.4|1.4|||Regression, Logistic|||Day 113||1.4|0.4|0.3959
71797561|NCT03548584|143094730|SUPERIORITY||LS Mean Difference|-0.27||||0.006|TWO_SIDED|95.0|-0.47|-0.08||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 10||-0.08|-0.47|0.0060
71674137|NCT02498444|142866793|OTHER|||||||0.14|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.14
71893394|NCT01642212|143307819|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2886|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of vomiting||||0.2886
71893395|NCT01642212|143307822|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED|||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. Both responses (no change, worsened) were analyzed collectively.|Cochran-Mantel-Haenszel|||Analysis of symptoms of participants with no symptoms at baseline||||0.1600
71893396|NCT01642212|143307824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 30% DSQ+pain score reduction||||0.0606
71797562|NCT03548584|143094730|SUPERIORITY||LS Mean Difference|-0.27||||0.0078|TWO_SIDED|95.0|-0.47|-0.07||MMRM method with model terms of treatment, trial site, visit, treatment-by-visit and baseline-by-visit interaction were used for analysis.|MMRM|||Change from Baseline at Week 12||-0.07|-0.47|0.0078
71797563|NCT03548584|143094731|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1975|TWO_SIDED|95.0|-0.05|0.26|||Cochran-Mantel-Haenszel|||Week 2||0.26|-0.05|0.1975
71797564|NCT03548584|143094731|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.0084|TWO_SIDED|95.0|-0.44|-0.06|||Cochran-Mantel-Haenszel|||Week 4||-0.06|-0.44|0.0084
71797565|NCT03548584|143094731|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0101|TWO_SIDED|95.0|-0.46|-0.06|||Cochran-Mantel-Haenszel|||Week 6||-0.06|-0.46|0.0101
71797566|NCT03548584|143094731|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0008|TWO_SIDED|95.0|-0.59|-0.15|||Cochran-Mantel-Haenszel|||Week 8||-0.15|-0.59|0.0008
71797567|NCT03548584|143094731|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0023|TWO_SIDED|95.0|-0.55|-0.12|||Cochran-Mantel-Haenszel|||Week 10||-0.12|-0.55|0.0023
71797568|NCT03548584|143094731|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.007|TWO_SIDED|95.0|-0.57|-0.09|||Cochran-Mantel-Haenszel|||Week 12||-0.09|-0.57|0.0070
71797569|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.1||||0.729|TWO_SIDED|95.0|0.64|1.91|||Cochran-Mantel-Haenszel|||\>/= 20%: Week 2||1.91|0.64|0.7290
71797570|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.09||||0.6196|TWO_SIDED|95.0|0.78|1.52|||Cochran-Mantel-Haenszel|||\>/=20%: Week 4||1.52|0.78|0.6196
71797571|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.16||||0.2718|TWO_SIDED|95.0|0.88|1.53|||Cochran-Mantel-Haenszel|||\>/=20%: Week 6||1.53|0.88|0.2718
71797572|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.52||||0.0004|TWO_SIDED|95.0|1.19|1.93|||Cochran-Mantel-Haenszel|||\>/=20%: Week 8||1.93|1.19|0.0004
71797573|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.42||||0.0006|TWO_SIDED|95.0|1.15|1.76|||Cochran-Mantel-Haenszel|||\>/=20%: Week 10||1.76|1.15|0.0006
71797574|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.41||||0.0004|TWO_SIDED|95.0|1.15|1.72|||Cochran-Mantel-Haenszel|||\>/=20%: Week 12||1.72|1.15|0.0004
71893397|NCT01642212|143307824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||Pearson's chi-square|||Analysis of \>/= 50% DSQ+pain score reduction||||0.0165
71893398|NCT01642212|143307825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7817|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7817
71674138|NCT02498444|142866794|OTHER|||||||0.23|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.23
71674139|NCT02498444|142866794|OTHER|||||||0.27|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||0.27
71797575|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.22||||0.7211|TWO_SIDED|95.0|0.39|3.85|||Cochran-Mantel-Haenszel|||\>/=30%: Week 2||3.85|0.39|0.7211
71797576|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.11||||0.7606|TWO_SIDED|95.0|0.57|2.14|||Cochran-Mantel-Haenszel|||\>/=30%: Week 4||2.14|0.57|0.7606
71797577|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.12||||0.5902|TWO_SIDED|95.0|0.74|1.68|||Cochran-Mantel-Haenszel|||\>/=30%: Week 6||1.68|0.74|0.5902
71797578|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.7||||0.0054|TWO_SIDED|95.0|1.14|2.54|||Cochran-Mantel-Haenszel|||\>/=30%: Week 8||2.54|1.14|0.0054
71797579|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.59||||0.0066|TWO_SIDED|95.0|1.11|2.26|||Cochran-Mantel-Haenszel|||\>/=30%: Week 10||2.26|1.11|0.0066
71797580|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.62||||0.0017|TWO_SIDED|95.0|1.18|2.23|||Cochran-Mantel-Haenszel|||\>/=30%: Week 12||2.23|1.18|0.0017
71797581|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.11||||0.9074|TWO_SIDED|95.0|0.2|5.97|||Cochran-Mantel-Haenszel|||\>/=40%: Week 2||5.97|0.20|0.9074
71797582|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|0.98||||0.9625|TWO_SIDED|95.0|0.36|2.64|||Cochran-Mantel-Haenszel|||\>/=40%: Week 4||2.64|0.36|0.9625
71797583|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.26||||0.512|TWO_SIDED|95.0|0.63|2.53|||Cochran-Mantel-Haenszel|||\>/=40%: Week 6||2.53|0.63|0.5120
71797584|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.98||||0.0244|TWO_SIDED|95.0|1.03|3.79|||Cochran-Mantel-Haenszel|||\>/=40%: Week 8||3.79|1.03|0.0244
71797585|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.86||||0.0161|TWO_SIDED|95.0|1.08|3.18|||Cochran-Mantel-Haenszel|||\>/=40%: Week 10||3.18|1.08|0.0161
71797586|NCT03548584|143094732|SUPERIORITY||Ratio of Response Rate|1.62||||0.0347|TWO_SIDED|95.0|1.0|2.61|||Cochran-Mantel-Haenszel|||\>/=40%: Week 12||2.61|1.00|0.0347
71797587|NCT03548584|143094733|SUPERIORITY||Ratio of Response Rate|0.64||||0.1503|TWO_SIDED|95.0|0.35|1.16|||Cochran-Mantel-Haenszel|||Week 2||1.16|0.35|0.1503
71797588|NCT03548584|143094733|SUPERIORITY||Ratio of Response Rate|1.07||||0.7559|TWO_SIDED|95.0|0.69|1.67|||Cochran-Mantel-Haenszel|||Week 4||1.67|0.69|0.7559
71797589|NCT03548584|143094733|SUPERIORITY||Ratio of Response Rate|1.23||||0.2246|TWO_SIDED|95.0|0.88|1.72|||Cochran-Mantel-Haenszel|||Week 6||1.72|0.88|0.2246
71797590|NCT03548584|143094733|SUPERIORITY||Ratio of Response Rate|1.38||||0.0276|TWO_SIDED|95.0|1.02|1.87|||Cochran-Mantel-Haenszel|||Week 8||1.87|1.02|0.0276
71674140|NCT02498444|142866794|OTHER|||||||0.65|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.65
71797591|NCT03548584|143094733|SUPERIORITY||Ratio of Response Rate|1.46||||0.0031|TWO_SIDED|95.0|1.12|1.89|||Cochran-Mantel-Haenszel|||Week 10||1.89|1.12|0.0031
71797592|NCT03548584|143094733|SUPERIORITY||Ratio of Response Rate|1.47||||0.0017|TWO_SIDED|95.0|1.14|1.89|||Cochran-Mantel-Haenszel|||Week 12||1.89|1.14|0.0017
71797593|NCT03548584|143094734|SUPERIORITY||Ratio of Response Rate|1.1||||0.8549|TWO_SIDED|95.0|0.4|3.03|||Cochran-Mantel-Haenszel|||Week 2||3.03|0.40|0.8549
71674141|NCT02498444|142866795|OTHER|||||||0.37|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 0||||0.37
71674142|NCT02498444|142866795|OTHER||||||<|0.01|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 12||||<0.01
71797594|NCT03548584|143094734|SUPERIORITY||Ratio of Response Rate|1.95||||0.0093|TWO_SIDED|95.0|1.14|3.32|||Cochran-Mantel-Haenszel|||Week 4||3.32|1.14|0.0093
71797595|NCT03548584|143094734|SUPERIORITY||Ratio of Response Rate|1.56||||0.0083|TWO_SIDED|95.0|1.1|2.22|||Cochran-Mantel-Haenszel|||Week 6||2.22|1.10|0.0083
71797596|NCT03548584|143094734|SUPERIORITY||Ratio of Response Rate|1.85|||<|0.0001|TWO_SIDED|95.0|1.32|2.58|||Cochran-Mantel-Haenszel|||Week 8||2.58|1.32|<.0001
71797597|NCT03548584|143094734|SUPERIORITY||Ratio of Response Rate|1.57||||0.0005|TWO_SIDED|95.0|1.18|2.09|||Cochran-Mantel-Haenszel|||Week 10||2.09|1.18|0.0005
71674143|NCT02498444|142866795|OTHER|||||||0.3|||||||Unadjusted repeated measure analysis|||Between-group comparison at postoperative hour 24||||0.30
71797598|NCT03548584|143094734|SUPERIORITY||Ratio of Response Rate|1.32||||0.016|TWO_SIDED|95.0|1.03|1.69|||Cochran-Mantel-Haenszel|||Week 12||1.69|1.03|0.0160
71797599|NCT02215070|143094738|OTHER|||||||0.12|||||||Chi-squared|||||||0.12
71674144|NCT02027545|142866796|SUPERIORITY|||||||0.491|||||||Regression, Logistic|||||||0.491
71674145|NCT02027545|142866797|SUPERIORITY|||||||0.049|||||||Regression, Logistic|||||||0.049
71674146|NCT02453334|142866799|OTHER||Odds Ratio (OR)|0.51||||0.0143|TWO_SIDED|95.0|0.3|0.87|||Cochran-Mantel-Haenszel|||||0.87|0.30|0.0143
71674147|NCT02453334|142866799|OTHER||Percentage difference|-15.6|||||TWO_SIDED|95.0|-28.01|-3.1||||||||-3.10|-28.01|
71674148|NCT02453334|142866801|OTHER||Odds Ratio (OR)|2.04||||0.0097|TWO_SIDED|95.0|1.19|3.5|||Cochran-Mantel-Haenszel|||||3.50|1.19|0.0097
71674149|NCT02453334|142866801|OTHER||Percentage difference|16.4|||||TWO_SIDED|95.0|4.19|28.51||||||Percentage difference||28.51|4.19|
71674150|NCT02453334|142866802|OTHER||Percentage difference|-2.7|||||TWO_SIDED|95.0|-12.85|7.45||||||||7.45|-12.85|
71674151|NCT02453334|142866802|OTHER||Odds Ratio (OR)|0.83||||0.5758|TWO_SIDED|95.0|0.43|1.6|||Cochran-Mantel-Haenszel|||Placebo group was used as the denominator for odds ratio calculation.||1.60|0.43|0.5758
71674152|NCT02453334|142866803|OTHER||Odds Ratio (OR)|1.4||||0.2772|TWO_SIDED|95.0|0.76|2.56||Placebo group was used as the denominator for odds ratio calculation|Cochran-Mantel-Haenszel|||||2.56|0.76|0.2772
71797600|NCT02215070|143094740|OTHER|||||||0.006|||||||Log Rank|||||||0.006
71797601|NCT02215070|143094741|OTHER|||||||0.002|||||||Log Rank|||||||0.002
71797602|NCT00653224|143094750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.33|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: 'The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.33|<0.001
71797603|NCT00653224|143094751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
71813350|NCT02709005|143129194|SUPERIORITY||Risk Difference (RD)|0.0|||>|0.999|TWO_SIDED|95.0|-0.18|0.14||The test was conducted using a Fisher's exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.||0.14|-0.18|>0.999
71813351|NCT00691132|143129198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.023|TWO_SIDED|95.0|-13.8|-1.2|||Mixed Models Analysis|||% difference between Placebo and PEITC periods in the ratio of \[pyridine-D4\]Hydroxy acid : \[pyridine-D4\] total NNAL||-1.2|-13.8|0.023
71813352|NCT00691132|143129199|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANOVA|||Total ITC||||0.005
71813353|NCT00691132|143129201|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANOVA|||Total ITC||||0.017
71813354|NCT00691132|143129202|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||0.039
71813355|NCT00691132|143129202|SUPERIORITY_OR_OTHER|||||||0.623|||||||Mixed Models Analysis|||||||0.623
71813356|NCT00691132|143129202|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||||||0.045
71813357|NCT03338621|143129273|SUPERIORITY||Cox Proportional Hazard|2.93|||<|0.001|TWO_SIDED|95.0|2.17|3.96|||Log Rank|||||3.96|2.17|<0.001
71813358|NCT02255032|143129285|SUPERIORITY||Mean Difference (Final Values)|-164.44|STANDARD_DEVIATION|173.148||0.0017|TWO_SIDED|95.0|-256.7|-72.2||The primary analysis of the primary efficacy endpoint was the comparison between the Baseline and Month 2 values for the 4 mg treatment group. No adjustments for multiplicity were necessary.|Paired t-test, two-sided|||"A paired t-test was used to assess the statistical significance of the change between Baseline and Month 2.~A sample size of 16 subjects would have 80% power to detect a difference of 75, assuming a standard deviation of 100, using a paired t-test with a 0.050 two-sided significance level."||-72.2|-256.7|0.0017
71813359|NCT02037438|143129286|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.03|STANDARD_ERROR_OF_MEAN|0.075||0.687|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.687
71797604|NCT00653224|143094752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|||<|0.001||95.0|-0.47|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.47|<0.001
71797605|NCT00653224|143094753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.52|<0.001
71797606|NCT00653224|143094754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.042||95.0|-0.49|-0.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.01|-0.49|0.042
71797607|NCT00653224|143094755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.014||95.0|-0.52|-0.06||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.52|0.014
71797608|NCT00653224|143094756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.036||95.0|-0.51|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-0.51|0.036
71797609|NCT00653224|143094757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.01||95.0|-0.48|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.48|0.010
71797610|NCT00653224|143094758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.026||95.0|-0.43|-0.03||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.43|0.026
71797611|NCT00653224|143094759|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25||||0.018||95.0|-0.45|-0.04||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.45|0.018
71797612|NCT00653224|143094760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.002||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.002
71813360|NCT02037438|143129287|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|-0.007|STANDARD_ERROR_OF_MEAN|0.539||0.989|TWO_SIDED||||||see Comments|Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate||||||0.989
71813361|NCT02037438|143129288|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.114|STANDARD_ERROR_OF_MEAN|0.141||0.417|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.417
71813362|NCT02037438|143129289|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.057|STANDARD_ERROR_OF_MEAN|0.078||0.468|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.468
71674153|NCT02453334|142866803|OTHER||Percentage difference|5.7|||||TWO_SIDED|95.0|-5.01|16.43||||||||16.43|-5.01|
71674154|NCT02453334|142866804|OTHER|||||||0.0011|||||||Log Rank|P-value was estimated using logrank test stratified by country||||||0.0011
71674155|NCT02453334|142866805|OTHER||Percentage difference|0.7|||||TWO_SIDED|95.0|-7.6|9.08||||||||9.08|-7.60|
71674156|NCT02453334|142866805|OTHER||Odds Ratio (OR)|1.05||||0.8924|TWO_SIDED|95.0|0.49|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.49|0.8924
71797613|NCT00653224|143094761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.006||95.0|-0.41|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.07|-0.41|0.006
71797614|NCT00653224|143094762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.003||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.47|0.003
71674157|NCT02453334|142866806|OTHER||Percentage difference|-9.8|||||TWO_SIDED|95.0|-20.41|0.77||||||||0.77|-20.41|
71674158|NCT02453334|142866806|OTHER||Odds Ratio (OR)|0.55||||0.074|TWO_SIDED|95.0|0.28|1.06|||Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.||1.06|0.28|0.0740
71797615|NCT00653224|143094763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
71797616|NCT00653224|143094764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||<|0.001||95.0|-0.57|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.57|<0.001
71797617|NCT00653224|143094765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.61|<0.001
71797618|NCT00653224|143094766|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.18|-0.59|<0.001
71797619|NCT00653224|143094767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0|-0.55|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-0.55|<0.001
71674159|NCT02453334|142866807|OTHER||Percentage difference|-12.1|||||TWO_SIDED|95.0|-23.31|-0.91||||||||-0.91|-23.31|
71674160|NCT02453334|142866807|OTHER||Odds Ratio (OR)|0.51||||0.0446|TWO_SIDED|95.0|0.26|0.99||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation||||0.99|0.26|0.0446
71674161|NCT02453334|142866808|OTHER||Percentage difference|-19.8|||||TWO_SIDED|95.0|-30.9|-8.69||||||||-8.69|-30.90|
71674162|NCT02453334|142866808|OTHER||Odds Ratio (OR)|0.3||||0.001|TWO_SIDED|95.0|0.14|0.63||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel|Placebo group was used as the denominator for odds ratio calculation.||||0.63|0.14|0.0010
71674163|NCT02453334|142866809|OTHER||Percentage difference|-21.4|||||TWO_SIDED|95.0|-33.22|-9.51||||||||-9.51|-33.22|
71674164|NCT02453334|142866809|OTHER||Odds Ratio (OR)|0.29||||0.0009|TWO_SIDED|95.0|0.13|0.61||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.61|0.13|0.0009
71674165|NCT02453334|142866810|OTHER||Percentage difference|-16.0|||||TWO_SIDED|95.0|-27.73|-4.26||||||||-4.26|-27.73|
71674166|NCT02453334|142866810|OTHER||Odds Ratio (OR)|0.34||||0.0093|TWO_SIDED|95.0|0.14|0.79||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||0.79|0.14|0.0093
71674167|NCT02453334|142866811|OTHER||Percentage difference|-4.4|||||TWO_SIDED|95.0|-15.37|6.57||||||||6.57|-15.37|
71674168|NCT02453334|142866811|OTHER||Odds Ratio (OR)|0.7||||0.4786|TWO_SIDED|95.0|0.26|1.89||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.89|0.26|0.4786
71674169|NCT02453334|142866812|OTHER||Percentage difference|-7.4|||||TWO_SIDED|95.0|-19.25|4.55||||||||4.55|-19.25|
71674170|NCT02453334|142866812|OTHER||Odds Ratio (OR)|0.54||||0.2084|TWO_SIDED|95.0|0.2|1.43||The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Cochran-Mantel-Haenszel||Placebo group was used as the denominator for odds ratio calculation.|||1.43|0.20|0.2084
71674171|NCT02453334|142866813|OTHER||Percentage difference|3.1|||||TWO_SIDED|95.0|-9.33|15.54||||||||15.54|-9.33|
71674172|NCT02453334|142866813|OTHER||Odds Ratio (OR)|1.25||||0.6508|TWO_SIDED|95.0|0.48|3.24|||Cochran-Mantel-Haenszel|The odds ratio (95% \[CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.|Placebo group was used as the denominator for odds ratio calculation.|||3.24|0.48|0.6508
71674173|NCT02453334|142866815|OTHER|||||||0.0063||||||P-value was estimated using logrank test stratified by pooled sites.|Log Rank|||||||0.0063
71840495|NCT04909801|143190275|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6225|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|||Day 141||2.0|0.7|0.6225
71674174|NCT00693498|142866819|OTHER||||||<|0.03||||||the reported value is for POD#1 assessment|Wald Wolfowitz|||||||<0.03
71674175|NCT00693498|142866819|OTHER|||||||0.29||||||for POD#2 assessment|Wald-Wolf|||||||0.29
71674176|NCT00302848|142866843|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.|Hazard Ratio (HR)|1.0|||<|0.05||95.0|0.6|1.8|||Regression, Cox|||Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)||1.8|0.6|<0.05
71674177|NCT01019694|142866992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.02|13.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||13.19|6.02|< 0.0001
71674178|NCT01019694|142866992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.0009||95.0|2.57|9.91|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||9.91|2.57|0.0009
71840496|NCT04909801|143190275|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.614|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 169||1.5|0.5|0.6140
71840497|NCT04909801|143190276|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8084|TWO_SIDED|95.0|0.4|2.9|||Regression, Logistic|||Day 29||2.9|0.4|0.8084
71674179|NCT01019694|142866993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.0006||95.0|2.29|8.28|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||8.28|2.29|0.0006
71674180|NCT01019694|142866993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.0001||95.0|4.41|10.39|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.39|4.41|< 0.0001
71674181|NCT01019694|142866994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|4.71|11.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||11.09|4.71|< 0.0001
71674182|NCT01019694|142866994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.44|12.83|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||12.83|6.44|< 0.0001
71674183|NCT01019694|142866995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|||<|0.0001||95.0|5.94|12.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||12.37|5.94|< 0.0001
71674184|NCT01019694|142866995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.44|10.96|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||10.96|4.44|< 0.0001
71674185|NCT01019694|142866996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|||<|0.0001||95.0|7.9|14.76|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||14.76|7.90|< 0.0001
71674186|NCT01019694|142866996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.23|11.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||11.23|4.23|< 0.0001
71674187|NCT01019694|142866998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.1167||95.0|-0.05|0.42|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.42|-0.05|0.1167
71674188|NCT01019694|142866998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0026||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|0.13|0.0026
71674189|NCT01019694|142866999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.2826||95.0|-0.11|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.38|-0.11|0.2826
71840498|NCT04909801|143190276|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.747|TWO_SIDED|95.0|0.5|2.3|||Regression, Logistic|||Day 57||2.3|0.5|0.7470
71840499|NCT04909801|143190276|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5233|TWO_SIDED|95.0|0.7|2.3|||Regression, Logistic|||Day 85||2.3|0.7|0.5233
71674190|NCT01019694|142866999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0013||95.0|0.16|0.66|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.66|0.16|0.0013
71674191|NCT01019694|142867000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0023||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.59|0.13|0.0023
71674192|NCT01019694|142867000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||<|0.0001||95.0|0.25|0.71|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.71|0.25|< 0.0001
71674193|NCT01019694|142867001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0006||95.0|0.18|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.65|0.18|0.0006
71674194|NCT01019694|142867001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0004||95.0|0.2|0.68|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.68|0.20|0.0004
71797620|NCT00653224|143094768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.59|<0.001
71797621|NCT00653224|143094769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.21|-0.63|<0.001
71797622|NCT00653224|143094770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||<|0.001||95.0|-0.56|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.17|-0.56|<0.001
71797623|NCT00653224|143094771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-0.63|<0.001
71893399|NCT01642212|143307826|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.1686|TWO_SIDED|95.0|-0.222|0.04||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||0.040|-0.222|0.1686
71674195|NCT01019694|142867002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0673||95.0|-0.02|0.47|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.47|-0.02|0.0673
71674196|NCT01019694|142867002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.0245||95.0|0.04|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.54|0.04|0.0245
71674197|NCT01019694|142867004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.5695||95.0|-0.24|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.24|0.5695
71674198|NCT01019694|142867004|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3093||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3093
71893400|NCT01642212|143307826|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03||||0.8046|TWO_SIDED|95.0|-0.269|0.21||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.210|-0.269|0.8046
71893401|NCT01642212|143307826|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.9239|TWO_SIDED|95.0|-0.199|0.219||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.219|-0.199|0.9239
71674199|NCT01019694|142867005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3578||95.0|-0.31|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.11|-0.31|0.3578
71674200|NCT01019694|142867005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.7433||95.0|-0.18|0.25|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.25|-0.18|0.7433
71674201|NCT01019694|142867006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.524||95.0|-0.29|0.15|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.15|-0.29|0.524
71674202|NCT01019694|142867006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3171||95.0|-0.34|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.34|0.3171
71674203|NCT01019694|142867007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2499||95.0|-0.38|0.1|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.10|-0.38|0.2499
71674204|NCT01019694|142867007|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6144||95.0|-0.31|0.18|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.18|-0.31|0.6144
71674205|NCT01019694|142867008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5142||95.0|-0.16|0.33|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.33|-0.16|0.5142
71674206|NCT01019694|142867008|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.2691||95.0|-0.39|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.11|-0.39|0.2691
71674207|NCT01019694|142867010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6236||95.0|-0.23|0.14|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.14|-0.23|0.6236
71674208|NCT01019694|142867010|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3342||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.09|-0.28|0.3342
71674209|NCT01019694|142867011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1884||95.0|-0.36|0.07|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.07|-0.36|0.1884
71674210|NCT01019694|142867011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.6978||95.0|-0.17|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.26|-0.17|0.6978
71674211|NCT01019694|142867012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4197||95.0|-0.32|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.13|-0.32|0.4197
71674212|NCT01019694|142867012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3949||95.0|-0.33|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.13|-0.33|0.3949
71674213|NCT01019694|142867013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.299||95.0|-0.38|0.12|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.12|-0.38|0.299
71674214|NCT01019694|142867013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1404||95.0|-0.44|0.06|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.06|-0.44|0.1404
71797624|NCT00653224|143094772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|||<|0.001||95.0|-0.53|-0.13||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.53|<0.001
71797625|NCT00653224|143094773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.15|-0.52|<0.001
71797626|NCT00653224|143094774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.53|-0.14||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.14|-0.53|<0.001
71813363|NCT02037438|143129290|SUPERIORITY_OR_OTHER||Provider-Effect Adjusted Difference|0.177|STANDARD_ERROR_OF_MEAN|0.061||0.003|TWO_SIDED||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers||||||0.003
71813364|NCT05375955|143129291|OTHER||Risk Difference (RD)|12.4||||0.0711|TWO_SIDED|95.0|-4.1|29.4|||Chan and Zhang (1999) method|||||29.4|-4.1|0.0711
71674215|NCT01019694|142867014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.463||95.0|-0.36|0.16|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.16|-0.36|0.463
71674216|NCT01019694|142867014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.3824||95.0|-0.15|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.38|-0.15|0.3824
71674217|NCT01019694|142867015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8282||95.0|-0.036|0.045|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.045|-0.036|0.8282
71674218|NCT01019694|142867015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.6587||95.0|-0.032|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.032|0.6587
71674219|NCT01019694|142867016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1185||95.0|-0.009|0.081|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.081|-0.009|0.1185
71674220|NCT01019694|142867016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.2651||95.0|-0.02|0.072|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.072|-0.020|0.2651
71674221|NCT01019694|142867017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5852||95.0|-0.058|0.033|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.033|-0.058|0.5852
71674222|NCT01019694|142867017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7242||95.0|-0.054|0.038|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.038|-0.054|0.7242
71674223|NCT01019694|142867018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0328||95.0|0.005|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||||0.110|0.005|0.0328
71674224|NCT01019694|142867018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8896||95.0|-0.058|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.050|-0.058|0.8896
71674225|NCT01019694|142867019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.402||95.0|-0.042|0.105|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.105|-0.042|0.402
71797627|NCT00653224|143094775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.32|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.32|<0.001
71797628|NCT00653224|143094776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001||95.0|-1.39|-0.36||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.36|-1.39|<0.001
71797629|NCT00653224|143094777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0|-1.2|-0.49||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.49|-1.20|<0.001
71797630|NCT00653224|143094778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.18|-0.35||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.35|-1.18|<0.001
71813365|NCT05375955|143129291|OTHER||Risk Difference (RD)|10.1||||0.129|TWO_SIDED|95.0|-6.1|26.8|||Chan and Zhang (1999) method|||||26.8|-6.1|0.1290
71893402|NCT01642212|143307827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73||||0.4835|TWO_SIDED|95.0|-2.806|1.339||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8||1.339|-2.806|0.4835
71674226|NCT01019694|142867019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.659||95.0|-0.057|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.090|-0.057|0.659
71674227|NCT01019694|142867020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0893||95.0|-0.01|0.139|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.139|-0.010|0.0893
71813366|NCT05375955|143129292|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||||24.3|-10.8|0.2712
71674228|NCT01019694|142867020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.5424||95.0|-0.052|0.099|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.099|-0.052|0.5424
71674229|NCT01019694|142867021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6396||95.0|-0.104|0.064|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.064|-0.104|0.6396
71674230|NCT01019694|142867021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6455||95.0|-0.106|0.066|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.066|-0.106|0.6455
71674231|NCT01019694|142867022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.2596||95.0|-0.038|0.141|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.141|-0.038|0.2596
71674232|NCT01019694|142867022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6659||95.0|-0.112|0.071|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.071|-0.112|0.6659
71674233|NCT01019694|142867024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.476||95.0|-0.4|0.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.19|-0.40|0.476
71674234|NCT01019694|142867024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.6976||95.0|-0.35|0.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.23|-0.35|0.6976
71797631|NCT00653224|143094779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.17|-0.45||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.45|-1.17|<0.001
71797632|NCT00653224|143094780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.17|-0.31||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.31|-1.17|<0.001
71797633|NCT00653224|143094781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.005||95.0|-1.26|-0.22||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.22|-1.26|0.005
71797634|NCT00653224|143094782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.18|-0.3||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-1.18|<0.001
71797635|NCT00653224|143094783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0|-0.87|-0.3||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.30|-0.87|<0.001
71797636|NCT00653224|143094784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.91|-0.24||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.24|-0.91|<0.001
71797637|NCT00653224|143094785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.86|-0.28||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.28|-0.86|<0.001
71797638|NCT00653224|143094786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.34|-0.13||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.13|-0.34|<0.001
71813367|NCT05375955|143129292|OTHER||Risk Difference (RD)|28.3||||0.0028|TWO_SIDED|95.0|7.7|47.5|||Chan and Zhang (1999) method|||||47.5|7.7|0.0028
71813368|NCT05375955|143129292|OTHER||Risk Difference (RD)|36.6||||0.0003|TWO_SIDED|95.0|14.7|56.4|||Chan and Zhang (1999) method|||||56.4|14.7|0.0003
71893403|NCT01642212|143307827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92||||0.0662|TWO_SIDED|95.0|-3.974|0.132||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12||0.132|-3.974|0.0662
71674235|NCT01019694|142867025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9506||95.0|-0.4|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.40|0.9506
71813369|NCT05375955|143129293|OTHER||Risk Difference (RD)|0.1||||0.5701|TWO_SIDED|95.0|-10.2|10.7|||Chan and Zhang (1999) method|||Week 1||10.7|-10.2|0.5701
71813370|NCT05375955|143129293|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
71813371|NCT05375955|143129293|OTHER||Risk Difference (RD)|9.6||||0.0532|TWO_SIDED|95.0|-2.0|23.7|||Chan and Zhang (1999) method|||Week 2||23.7|-2.0|0.0532
71813372|NCT05375955|143129293|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
71813373|NCT05375955|143129293|OTHER||Risk Difference (RD)|0.5||||0.5123|TWO_SIDED|95.0|-14.4|15.7|||Chan and Zhang (1999) method|||Week 4||15.7|-14.4|0.5123
71813374|NCT05375955|143129293|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
71813375|NCT05375955|143129293|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 6||24.8|-8.9|0.2736
71813376|NCT05375955|143129293|OTHER||Risk Difference (RD)|3.0||||0.3967|TWO_SIDED|95.0|-13.0|19.8|||Chan and Zhang (1999) method|||Week 6||19.8|-13.0|0.3967
71813377|NCT05375955|143129293|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 8||20.2|-13.6|0.3997
71797639|NCT00653224|143094787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.09||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.34|<0.001
71797640|NCT00653224|143094788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.33|-0.12||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.12|-0.33|<0.001
71797641|NCT00653224|143094789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.11||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.11|-0.32|<0.001
71674236|NCT01019694|142867025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2362||95.0|-0.15|0.62|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.62|-0.15|0.2362
71797642|NCT00653224|143094790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.008||95.0|-0.3|-0.05||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.30|0.008
71797643|NCT00653224|143094791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.09||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.09|-0.30|<0.001
71797644|NCT00653224|143094792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.384||95.0|-0.15|0.06||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.06|-0.15|0.384
71797645|NCT00653224|143094793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.063||95.0|-0.24|0.01||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.24|0.063
71797646|NCT00653224|143094794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.124||95.0|-0.19|0.02||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.02|-0.19|0.124
71797647|NCT00653224|143094795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.002||95.0|-0.28|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.28|0.002
71813378|NCT05375955|143129293|OTHER||Risk Difference (RD)|-1.6||||0.5461|TWO_SIDED|95.0|-17.7|15.3|||Chan and Zhang (1999) method|||Week 8||15.3|-17.7|0.5461
71813379|NCT05375955|143129293|OTHER||Risk Difference (RD)|7.8||||0.2736|TWO_SIDED|95.0|-8.9|24.8|||Chan and Zhang (1999) method|||Week 10||24.8|-8.9|0.2736
71813380|NCT05375955|143129293|OTHER||Risk Difference (RD)|5.4||||0.2754|TWO_SIDED|95.0|-11.0|22.1|||Chan and Zhang (1999) method|||Week 10||22.1|-11.0|0.2754
71813381|NCT05375955|143129293|OTHER||Risk Difference (RD)|12.6||||0.0977|TWO_SIDED|95.0|-4.8|30.3|||Chan and Zhang (1999) method|||Week 12||30.3|-4.8|0.0977
71813382|NCT05375955|143129293|OTHER||Risk Difference (RD)|14.9||||0.0542|TWO_SIDED|95.0|-2.8|33.2|||Chan and Zhang (1999) method|||Week 12||33.2|-2.8|0.0542
71813383|NCT05375955|143129294|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
71813384|NCT05375955|143129294|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
71813385|NCT05375955|143129294|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 1||24.3|-2.1|0.0436
71674237|NCT01019694|142867026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.5645||95.0|-0.3|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.54|-0.30|0.5645
71674238|NCT01019694|142867026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.0163||95.0|0.1|0.95|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.95|0.10|0.0163
71674239|NCT01019694|142867027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.4339||95.0|-0.6|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.26|-0.60|0.4339
71674240|NCT01019694|142867027|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.4886||95.0|-0.28|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.59|-0.28|0.4886
71674241|NCT01019694|142867028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7637||95.0|-0.5|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol||0.37|-0.50|0.7637
71674242|NCT01019694|142867028|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.3755||95.0|-0.24|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols||0.65|-0.24|0.3755
71674243|NCT04244084|142867031|SUPERIORITY||Median Difference (Final Values)|-0.89||||0.0155|TWO_SIDED|95.0|-1.61|-0.17|||ANCOVA|Site used as covariate||Mean differences (MMH-407 vs. Placebo) were compared||-0.17|-1.61|0.0155
71674244|NCT04244084|142867032|SUPERIORITY|||||||0.1839|||||||Wilcoxon (Mann-Whitney)|||||||0.1839
71797648|NCT00653224|143094796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.016||95.0|-0.28|-0.03||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.03|-0.28|0.016
71674245|NCT04244084|142867033|SUPERIORITY|||||||0.064||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0640
71674246|NCT04244084|142867034|SUPERIORITY|||||||0.1927|||||||Wilcoxon (Mann-Whitney)|||||||0.1927
71674247|NCT04244084|142867035|SUPERIORITY|||||||0.0014||||||Day used as independent strata.|Cochran-Mantel-Haenszel|||||||0.0014
71674248|NCT04244084|142867036|SUPERIORITY|||||||0.2009|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 1 row."||||0.2009
71674249|NCT04244084|142867036|SUPERIORITY|||||||0.4717|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 2 row."||||0.4717
71674250|NCT04244084|142867036|SUPERIORITY|||||||0.5144|||||||Wilcoxon (Mann-Whitney)|||"This analysis applies to Day 3 row."||||0.5144
71674251|NCT04244084|142867037|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71674252|NCT04244084|142867039|SUPERIORITY|||||||0.5981|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 1 row."||||0.5981
71813386|NCT05375955|143129294|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
71674253|NCT04244084|142867039|SUPERIORITY|||||||0.4913|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 2 row."||||0.4913
71674254|NCT04244084|142867039|SUPERIORITY|||||||0.6441|||||||Kruskal-Wallis|||"This analysis applies to Systolic blood pressure/Visit 3 row."||||0.6441
71674255|NCT04244084|142867039|SUPERIORITY|||||||0.8186|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 1 row."||||0.8186
71674256|NCT04244084|142867039|SUPERIORITY|||||||0.8931|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 2 row."||||0.8931
71674257|NCT04244084|142867039|SUPERIORITY|||||||0.5887|||||||Kruskal-Wallis|||"This analysis applies to Diastolic blood pressure/Visit 3 row."||||0.5887
71674258|NCT04244084|142867040|SUPERIORITY|||||||0.4426|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 1 row."||||0.4426
71674259|NCT04244084|142867040|SUPERIORITY|||||||0.5998|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 2 row."||||0.5998
71674260|NCT04244084|142867040|SUPERIORITY|||||||0.971|||||||Kruskal-Wallis|||"This analysis applies to Heart rate/Visit 3 row."||||0.9710
71674261|NCT04244084|142867041|SUPERIORITY|||||||0.6197|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 1 row."||||0.6197
71674262|NCT04244084|142867041|SUPERIORITY|||||||0.7042|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 2 row."||||0.7042
71674263|NCT04244084|142867041|SUPERIORITY|||||||0.7693|||||||Kruskal-Wallis|||"This analysis applies to Breathing rate/Visit 3 row."||||0.7693
71674264|NCT04244084|142867042|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71674265|NCT04632069|142867058|SUPERIORITY||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.4||0.009|TWO_SIDED||||||Regression, Linear|repeated measures linear regression: time periods: -14 to Day 0, Day 1-18(independent variable); daily po volumes (Dependent Variable)||Daily change in po feeding volumes expressed as po ml/kg/d \[reported as the mean daily change from Day 1 to 18 during NAC/NAC+taVNS minus baseline mean daily change Day -14 to day 0 (before treatment)\] Null hypothesis: there will be no significant difference in daily change in po feeding volume (ml/kg/d) from baseline to during treatment Power analysis: Estimated +0.2 ml/kg/d before taVNS, and +3ml/kg/d during the 18days of NAC+taVNS treatment, requiring 10 infants with power of 80%, a=0.05.||||0.009
71674266|NCT04632069|142867059|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.08||0.01|TWO_SIDED||||||t-test, 2 sided|paired t-test|mean difference between \[GSH\] Day 4 of NAC and \[GSH\] at baseline|\[GSH\] at baseline compared with \[GSH\] at day 4 of NAC- by paired t-test in which each participant's \[GSH\] is compared at 2 time points Null hypothesis: the \[GSH\] in the basal ganglia will be no different after Day 4 of NAC than \[GSH\] at baseline Power calculation:With 80% power, alpha of 0.05, we would need 7 patients to show a significant change in basal ganglia \[GSH\] of 0.14 +/- 0.13mM from baseline to Day 4 of NAC (paired t-test).||||0.01
71813387|NCT05375955|143129294|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 2||14.9|-7.8|0.2697
71813388|NCT05375955|143129294|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 2||32.0|3.2|0.0104
71797649|NCT00653224|143094797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.003||95.0|-0.27|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.06|-0.27|0.003
71797650|NCT00653224|143094798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.088||95.0|-0.2|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.20|0.088
71797651|NCT00653224|143094799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.117||95.0|-0.23|0.03||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.03|-0.23|0.117
71797652|NCT00653224|143094800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.065||95.0|-0.21|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.01|-0.21|0.065
71797653|NCT00653224|143094801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
71797654|NCT00653224|143094802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.002||95.0|-0.33|-0.08||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.33|0.002
71797655|NCT00653224|143094803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.32|<0.001
71797656|NCT00653224|143094804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.30|<0.001
71797657|NCT00653224|143094805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.006||95.0|-0.29|-0.05||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.29|0.006
71797658|NCT00653224|143094806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
71797659|NCT00653224|143094807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||<|0.001||95.0|-0.31|-0.1||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.31|<0.001
71813389|NCT05375955|143129294|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
71797660|NCT00653224|143094808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.011||95.0|-0.29|-0.04||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.04|-0.29|0.011
71797661|NCT00653224|143094809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
71797662|NCT00653224|143094810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.004||95.0|-0.27|-0.05||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.05|-0.27|0.004
71797663|NCT00653224|143094811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.1||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.10|-0.34|<0.001
71797664|NCT00653224|143094812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-0.29|<0.001
71797665|NCT00653224|143094813|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
71797666|NCT00653224|143094814|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) is generally used to detect 'shift alternatives'. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.||||<0.001
71797667|NCT00653224|143094815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.027||95.0|-2.56|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.16|-2.56|0.027
71797668|NCT00653224|143094816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.554||95.0|-1.56|0.84||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.84|-1.56|0.554
71797669|NCT00653224|143094817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.015||95.0|-2.72|-0.29||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.29|-2.72|0.015
71797670|NCT00653224|143094818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.016||95.0|-8.34|-0.86||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.86|-8.34|0.016
71813390|NCT05375955|143129294|OTHER||Risk Difference (RD)|14.3||||0.0129|TWO_SIDED|95.0|2.6|30.3|||Chan and Zhang (1999) method|||Week 4||30.3|2.6|0.0129
71813391|NCT05375955|143129294|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 4||38.9|8.0|0.0024
71797671|NCT00653224|143094819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.33||||0.017||95.0|-7.88|-0.79||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.79|-7.88|0.017
71893404|NCT01642212|143307827|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8||||0.1091|TWO_SIDED|95.0|-4.006|0.41||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16||0.410|-4.006|0.1091
71893405|NCT01299025|143307828|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71797672|NCT00653224|143094820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.25||||0.027||95.0|-8.02|-0.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.47|-8.02|0.027
71797673|NCT00653224|143094821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44||||0.023||95.0|-8.25|-0.63||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.63|-8.25|0.023
71797674|NCT00653224|143094822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.56||||0.015||95.0|-8.23|-0.89||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.89|-8.23|0.015
71797675|NCT00653224|143094823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.11||||0.036||95.0|-7.95|-0.27||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.27|-7.95|0.036
71797676|NCT00653224|143094824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51||||0.102||95.0|-9.95|0.93||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.93|-9.95|0.102
71797677|NCT00653224|143094825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.493||95.0|-5.66|2.78||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||2.78|-5.66|0.493
71797678|NCT00653224|143094826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.117||95.0|-9.91|1.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||1.15|-9.91|0.117
71813392|NCT05375955|143129294|OTHER||Risk Difference (RD)|21.2||||0.0024|TWO_SIDED|95.0|8.0|38.9|||Chan and Zhang (1999) method|||Week 6||38.9|8.0|0.0024
71813393|NCT05375955|143129294|OTHER||Risk Difference (RD)|22.9||||0.0018|TWO_SIDED|95.0|9.5|40.1|||Chan and Zhang (1999) method|||Week 6||40.1|9.5|0.0018
71896347|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|5.93||||0.002|TWO_SIDED|95.0|1.89|18.611||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||18.611|1.890|0.002
71797679|NCT00653224|143094827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.58||||0.409||95.0|-15.65|6.49||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.49|-15.65|0.409
71797680|NCT00653224|143094828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.54||||0.432||95.0|-16.1|7.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||7.01|-16.10|0.432
71797681|NCT00653224|143094829|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.24||||0.45||95.0|-15.46|6.99||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||6.99|-15.46|0.450
71797682|NCT00653224|143094830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.37||||0.251||95.0|-17.4|4.67||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||4.67|-17.40|0.251
71797683|NCT00653224|143094831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.06||||0.258||95.0|-19.48|5.36||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.36|-19.48|0.258
71797684|NCT00653224|143094832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.96||||0.288||95.0|-17.13|5.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||5.22|-17.13|0.288
71797685|NCT00653224|143094833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.91|||<|0.001||95.0|-9.34|-2.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.47|-9.34|<0.001
71797686|NCT00653224|143094834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.62|||<|0.001||95.0|-9.88|-3.35||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-3.35|-9.88|<0.001
71797687|NCT00653224|143094835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69||||0.001||95.0|-9.16|-2.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-2.21|-9.16|0.001
71797688|NCT00653224|143094836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.027||95.0|-1.29|-0.08||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.08|-1.29|0.027
71813394|NCT05375955|143129294|OTHER||Risk Difference (RD)|33.3||||0.0001|TWO_SIDED|95.0|17.8|51.8|||Chan and Zhang (1999) method|||Week 6||51.8|17.8|0.0001
71674267|NCT03412734|142867073|OTHER||Odds Ratio (OR)|10.6|||<|0.001|TWO_SIDED|95.0|3.02|37.34||p-value is adjusted for baseline BV (Bacterial Vaginosis)|Regression, Logistic|||We hypothesized that chlorhexidine would have a lower bacterial count compared to iodine. Our sample size was calculated to be 71 patients per arm to detect a 22% difference in cultures defined as contaminated at 90 minutes from surgical preparation.||37.34|3.02|<0.001
71797689|NCT00653224|143094837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.535||95.0|-0.7|0.37||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||0.37|-0.70|0.535
71797690|NCT00653224|143094838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.042||95.0|-1.26|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: 'The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.'||-0.02|-1.26|0.042
71797691|NCT00653224|143094839|SUPERIORITY_OR_OTHER|||||||0.171||95.0||||If the p-value of this estimated difference is lower than 5% the change from baseline is considered as different between the two treatment groups.|Repeated measure analysis (CATMOD)|||The Null Hypothesis is expressed as follows: 'The change from baseline to endpoint visit in score category (ESS score \< 8 or \>= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.'||||0.171
71797692|NCT01896895|143094856|SUPERIORITY||LS mean difference|-1.2|||=|0.0004|TWO_SIDED|95.0|-1.9|-0.6|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. First step of hierarchy is hypothesis of superiority of 50 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||-0.6|-1.9|=0.0004
71797693|NCT01896895|143094856|SUPERIORITY||LS mean difference|-0.5|||=|0.1452|TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. Second step of hierarchy is hypothesis of superiority of 25 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.||0.2|-1.1|=0.1452
71797694|NCT00293384|143094859|SUPERIORITY_OR_OTHER||proportion|0.57||||0.1|TWO_SIDED|||||85% statistical power|Simon optimal design|||Optimal Simon design for phase II study. p0=45% p1=65%.||||0.10
71797695|NCT00293384|143094860|SUPERIORITY_OR_OTHER||proportion|0.63||||||||||||||||||
71797696|NCT00293384|143094862|SUPERIORITY_OR_OTHER||proportion|0.06|||||TWO_SIDED|||||||||||||
71797697|NCT04482179|143094863|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
71797698|NCT04482179|143094864|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<.05
71797699|NCT04300296|143094954|OTHER||Posterior median difference|-13.9|||||TWO_SIDED|95.0|-44.8|19.3|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||19.3|-44.8|
71797700|NCT04300296|143094954|OTHER||Posterior median difference|14.1|||||TWO_SIDED|95.0|-17.0|40.7|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||40.7|-17.0|
71797701|NCT04300296|143094954|OTHER||Posterior median difference|6.5|||||TWO_SIDED|95.0|-25.4|35.4|||||Bayesian model to obtain the posterior distribution of the treatment difference between AIN457 and placebo|||35.4|-25.4|
71797702|NCT01633944|143094979|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.67||||0.0012|TWO_SIDED|95.0|-1.07|-0.26|||ANCOVA|||||-0.26|-1.07|0.0012
71797703|NCT01633944|143094980|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction||||0.0012
71797704|NCT01633944|143094980|SUPERIORITY_OR_OTHER|||||||0.0754|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥50% pain reduction||||0.0754
71797705|NCT04889625|143095016|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.0085|||TWO_SIDED|95.0|-0.017|0.017|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Distance (4m)||0.017|-0.017|
71797706|NCT04889625|143095016|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.0108|||TWO_SIDED|95.0|-0.051|-0.008|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Intermediate (64cm)||-0.008|-0.051|
71797707|NCT04889625|143095016|NON_INFERIORITY|This study was powered to demonstrate non-inferiority of the Test lens relative to the Control lens with respect to binocular HLHC distance, intermediate and near visual acuity. A non-inferiority margin of 0.05 logMAR was used; (0.05) logMAR is approximately half a line on an ETDRS chart.|least-square mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.0129|||TWO_SIDED|95.0|-0.062|-0.011|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A - delefilcon A|Near (40cm)||-0.011|-0.062|
71797708|NCT04889625|143095017|NON_INFERIORITY|This study was powered to demonstrate the primary hypotheses. However, the final sample size calculation was deemed large enough to test for Non-inferiority of the Test relative to the Control. A non-inferiority margin of -5 points was used.|least-square mean difference|6.3|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|2.0|10.5|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as senofilcon A (C3)- delefilcon A|||10.5|2.0|
71797709|NCT03746522|143095020|OTHER|||||||0.0006||||||P-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||0.0006
71797710|NCT03746522|143095021|OTHER|||||||0.0005||||||p-value was one-sided and compared with alpha = 0.025|Rubin's Rule|||||||0.0005
71797711|NCT03746522|143095022|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha=0.025.|Rubin's Rule|||||||<0.0001
71797712|NCT03746522|143095023|OTHER||||||<|0.0001||||||p-value was one-sided and compared with alpha = 0.025.|Rubin's Rule|||||||<0.0001
71797713|NCT02659020|143095045|SUPERIORITY||Hazard Ratio (HR)|0.945||||0.775|TWO_SIDED|95.0|0.639|1.397||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.397|0.639|0.775
71797714|NCT02659020|143095055|SUPERIORITY||Hazard Ratio (HR)|0.667||||0.148|TWO_SIDED|95.0|0.385|1.158||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.158|0.385|0.148
71797715|NCT02659020|143095056|SUPERIORITY||Hazard Ratio (HR)|0.692||||0.055|TWO_SIDED|95.0|0.476|1.007||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.007|0.476|0.055
71797716|NCT02659020|143095056|SUPERIORITY||Hazard Ratio (HR)|0.828||||0.482|TWO_SIDED|95.0|0.49|1.398||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank|||||1.398|0.490|0.482
71797717|NCT02659020|143095057|SUPERIORITY||Odds Ratio (OR)|1.589||||0.1891|TWO_SIDED|95.0|0.794|3.179||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||3.179|0.794|0.1891
71896261|NCT00906789|143314649|NON_INFERIORITY_OR_EQUIVALENCE|Given a continuous confidence score (0-100), the trapezoidal method was used to obtain the area under the LROC with bootstrapping at 10,000 iterations to obtain the 95% confidence interval (CI). Acceptance criteria for tests of non-inferiority and superiority were previously set at 95% CI upper bound of ΔAUCUA-SV less than δ=0.1 and δ=0, respectively. If the 95% CI upper bound difference of UA-SV is less than 0.1, then SV is non-inferior. If it is 0 or less than 0, then SV is superior.||||||0.05|||||||Bootstraping|||The sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater. This sample size was calculated using PASS software (Hintze, 2008). Settings: • α = 0.025. • one-sided test • AUCA = 0.80 and AUCSV = 0.90.• 2:1 ratio of patients with nodules to those without • areas calculated for the entire curves • correlation 0.3\* • discrete data. • standard deviation ratios of 1\*.||||0.05
71896262|NCT02334267|143314652|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
71797718|NCT02659020|143095057|SUPERIORITY||Odds Ratio (OR)|2.668||||0.0642|TWO_SIDED|95.0|0.923|7.71||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||7.710|0.923|0.0642
71797719|NCT02659020|143095058|SUPERIORITY||Odds Ratio (OR)|1.106||||0.7724|TWO_SIDED|95.0|0.558|2.194||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.194|0.558|0.7724
71797720|NCT02659020|143095058|SUPERIORITY||Odds Ratio (OR)|1.222||||0.6508|TWO_SIDED|95.0|0.513|2.911||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Exact Mantel-Haenszel test||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||2.911|0.513|0.6508
71797721|NCT02659020|143095059|SUPERIORITY||Hazard Ratio (HR)|0.661||||0.073|TWO_SIDED|95.0|0.419|1.041||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.041|0.419|0.073
71797722|NCT02659020|143095059|SUPERIORITY||Hazard Ratio (HR)|0.703||||0.225|TWO_SIDED|95.0|0.395|1.253||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|||1.253|0.395|0.225
71813395|NCT05375955|143129294|OTHER||Risk Difference (RD)|15.2||||0.0259|TWO_SIDED|95.0|-0.1|32.5|||Chan and Zhang (1999) method|||Week 8||32.5|-0.1|0.0259
71840500|NCT04909801|143190276|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7295|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 113||1.6|0.5|0.7295
71840501|NCT04909801|143190276|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7621|TWO_SIDED|95.0|0.6|1.9|||Regression, Logistic|||Day 141||1.9|0.6|0.7621
71840502|NCT04909801|143190276|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.6861|TWO_SIDED|95.0|0.5|1.6|||Regression, Logistic|||Day 169||1.6|0.5|0.6861
71840503|NCT04909801|143190277|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3117|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 29||1.2|0.5|0.3117
71840504|NCT04909801|143190277|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.612|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.6120
71840505|NCT04909801|143190277|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4339|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 85||1.3|0.5|0.4339
71840506|NCT04909801|143190277|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.5||||0.1963|TWO_SIDED|95.0|0.8|2.6|||Regression, Logistic|||Day 113||2.6|0.8|0.1963
71893406|NCT03577990|143307833|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|0.125||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
71896263|NCT02334267|143314653|SUPERIORITY_OR_OTHER|||||||0.4||||||trend analysis over time|Mixed Models Analysis|||||||0.4
71840507|NCT04909801|143190277|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3275|TWO_SIDED|95.0|0.8|2.3|||Regression, Logistic|||Day 141||2.3|0.8|0.3275
71840508|NCT04909801|143190277|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9113|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Day 169||1.7|0.6|0.9113
71840509|NCT04909801|143190278|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1247|TWO_SIDED|95.0|0.4|1.1|||Regression, Logistic|||Day 29||1.1|0.4|0.1247
71840510|NCT04909801|143190278|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5656|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 57||1.4|0.6|0.5656
71840511|NCT04909801|143190278|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.897|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.8970
71896264|NCT02334267|143314654|SUPERIORITY_OR_OTHER|||||||0.003||||||trend analysis over time|Mixed Models Analysis|||||||0.003
71840512|NCT04909801|143190278|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9175|TWO_SIDED|95.0|0.7|1.6|||Regression, Logistic|||Day 113||1.6|0.7|0.9175
71840513|NCT04909801|143190278|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5996|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 141||1.7|0.7|0.5996
71896265|NCT02334267|143314655|SUPERIORITY_OR_OTHER||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis|||||||<0.0001
71896266|NCT03291197|143314668|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.||||0.043
71674268|NCT00402688|142867092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.063||||||95.0|-0.089|0.215|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).|||0.215|-0.089|
71674269|NCT00402688|142867092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.045||||||95.0|-0.106|0.195|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).|||0.195|-0.106|
71840514|NCT04909801|143190278|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.3534|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.3534
71840515|NCT04909801|143190279|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1641|TWO_SIDED|95.0|0.2|1.3|||Regression, Logistic|||Day 29||1.3|0.2|0.1641
71840516|NCT04909801|143190279|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5905|TWO_SIDED|95.0|0.5|1.5|||Regression, Logistic|||Day 57||1.5|0.5|0.5905
71840517|NCT04909801|143190279|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7146|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 85||1.5|0.6|0.7146
71840518|NCT04909801|143190279|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.7416|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 113||1.7|0.7|0.7416
71840519|NCT04909801|143190279|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9026|TWO_SIDED|95.0|0.6|1.5|||Regression, Logistic|||Day 141||1.5|0.6|0.9026
71840520|NCT04909801|143190279|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.2605|TWO_SIDED|95.0|0.5|1.2|||Regression, Logistic|||Day 169||1.2|0.5|0.2605
71840521|NCT04909801|143190280|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.6||||0.1078|TWO_SIDED|95.0|0.3|1.1|||Regression, Logistic|||Day 29||1.1|0.3|0.1078
71840522|NCT04909801|143190280|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.7||||0.1855|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||Day 57||1.2|0.4|0.1855
71840523|NCT04909801|143190280|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.5223|TWO_SIDED|95.0|0.6|1.4|||Regression, Logistic|||Day 85||1.4|0.6|0.5223
71840524|NCT04909801|143190280|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.8||||0.4078|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 113||1.3|0.5|0.4078
71840525|NCT04909801|143190280|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.5238|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 141||1.8|0.7|0.5238
71840526|NCT04909801|143190280|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.474|TWO_SIDED|95.0|0.5|1.3|||Regression, Logistic|||Day 169||1.3|0.5|0.4740
71840527|NCT04909801|143190281|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.6565|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Day 29||2.9|0.5|0.6565
71840528|NCT04909801|143190281|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.701|TWO_SIDED|95.0|0.6|2.1|||Regression, Logistic|||Day 57||2.1|0.6|0.7010
71840529|NCT04909801|143190281|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3683|TWO_SIDED|95.0|0.8|2.1|||Regression, Logistic|||Day 85||2.1|0.8|0.3683
71840530|NCT04909801|143190281|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6372|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 113||1.8|0.7|0.6372
71840531|NCT04909801|143190281|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.2922|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 141||2.0|0.8|0.2922
71840532|NCT04909801|143190281|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.8178|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|||Day 169||1.7|0.7|0.8178
71840533|NCT04909801|143190282|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.0||||0.9599|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||Day 29||2.2|0.4|0.9599
71840534|NCT04909801|143190282|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|0.9||||0.7899|TWO_SIDED|95.0|0.5|1.7|||Regression, Logistic|||Day 57||1.7|0.5|0.7899
71840535|NCT04909801|143190282|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.6305|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 85||1.9|0.7|0.6305
71840536|NCT04909801|143190282|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.3||||0.3491|TWO_SIDED|95.0|0.8|2.0|||Regression, Logistic|||Day 113||2.0|0.8|0.3491
71840537|NCT04909801|143190282|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.2||||0.4916|TWO_SIDED|95.0|0.7|1.9|||Regression, Logistic|||Day 141||1.9|0.7|0.4916
71840538|NCT04909801|143190282|SUPERIORITY|Abatacept vs. Adalimumab|Adjusted Odds Ratio|1.1||||0.5697|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Day 169||1.8|0.7|0.5697
71896267|NCT01633060|143314670|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.67|||<|0.001|ONE_SIDED|95.0|0.53||||Log Rank||||||0.53|<0.001
71840539|NCT04909801|143190283|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.0977|TWO_SIDED|95.0|0.0|0.5|||longitudinal|||Day 29||0.5|-0.0|0.0977
71840540|NCT04909801|143190283|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.2889|TWO_SIDED|95.0|-0.1|0.5|||longitudinal|||Day 57||0.5|-0.1|0.2889
71840541|NCT04909801|143190283|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.7676|TWO_SIDED|95.0|-0.3|0.4|||longitudinal|||Day 85||0.4|-0.3|0.7676
71840542|NCT04909801|143190283|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.6157|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.6157
71840543|NCT04909801|143190283|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.3904|TWO_SIDED|95.0|-0.4|0.2|||longitudinal|||Day 141||0.2|-0.4|0.3904
71840544|NCT04909801|143190283|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.8359|TWO_SIDED|95.0|-0.4|0.3|||longitudinal|||Day 169||0.3|-0.4|0.8359
71677321|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.661|||||TWO_SIDED|95.0|0.44|0.994||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.994|0.440|
71840545|NCT04909801|143190284|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.4||||0.7852|TWO_SIDED|95.0|-2.3|3.1|||longitudinal|||Day 29||3.1|-2.3|0.7852
71840546|NCT04909801|143190284|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6336|TWO_SIDED|95.0|-2.0|3.3|||longitudinal|||Day 57||3.3|-2.0|0.6336
71840547|NCT04909801|143190284|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.9||||0.4879|TWO_SIDED|95.0|-3.5|1.7|||longitudinal|||Day 85||1.7|-3.5|0.4879
71840548|NCT04909801|143190284|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2812|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.2812
71840549|NCT04909801|143190284|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1205|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1205
71840550|NCT04909801|143190284|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||longitudinal|||Day 169||1.3|-4.1|0.3001
71840551|NCT04909801|143190285|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.2||||0.4107|TWO_SIDED|95.0|-1.6|4.0|||longitudinal|||Day 29||4.0|-1.6|0.4107
71840552|NCT04909801|143190285|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.5||||0.6824|TWO_SIDED|95.0|-2.1|3.2|||longitudinal|||Day 57||3.2|-2.1|0.6824
71840553|NCT04909801|143190285|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.7||||0.5793|TWO_SIDED|95.0|-3.4|1.9|||longitudinal|||Day 85||1.9|-3.4|0.5793
71840554|NCT04909801|143190285|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2883|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 113||1.2|-4.2|0.2883
71840555|NCT04909801|143190285|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.7||||0.1285|TWO_SIDED|95.0|-3.9|0.5|||longitudinal|||Day 141||0.5|-3.9|0.1285
71840556|NCT04909801|143190285|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.5||||0.2815|TWO_SIDED|95.0|-4.2|1.2|||longitudinal|||Day 169||1.2|-4.2|0.2815
71840557|NCT04909801|143190290|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.3||||0.0099|TWO_SIDED|95.0|0.1|0.5|||longitudinal|||Day 29||0.5|0.1|0.0099
71840558|NCT04909801|143190290|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.1519|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 57||0.4|-0.1|0.1519
71840559|NCT04909801|143190290|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.2505|TWO_SIDED|95.0|-0.1|0.4|||longitudinal|||Day 85||0.4|-0.1|0.2505
71797723|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.332|TWO_SIDED|95.0|0.834|1.764||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.764|0.834|0.332
71797724|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.813||||0.389|TWO_SIDED|95.0|0.514|1.287||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||1.287|0.514|0.389
71797725|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.598||||0.02|TWO_SIDED|95.0|0.386|0.926||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||0.926|0.386|0.020
71797726|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.821|TWO_SIDED|95.0|0.622|1.442||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.442|0.622|0.821
71797727|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.931||||0.812|TWO_SIDED|95.0|0.574|1.509||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||1.509|0.574|0.812
71797728|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.162|TWO_SIDED|95.0|0.893|2.055||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||2.055|0.893|0.162
71797729|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.881||||0.619|TWO_SIDED|95.0|0.55|1.413||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||1.413|0.550|0.619
71797730|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.597|TWO_SIDED|95.0|0.746|1.724||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||1.724|0.746|0.597
71797731|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.766||||0.38|TWO_SIDED|95.0|0.425|1.381||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||1.381|0.425|0.380
71797732|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.046||||0.877|TWO_SIDED|95.0|0.635|1.723||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Fatigue||1.723|0.635|0.877
71797733|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.102||||0.791|TWO_SIDED|95.0|0.568|2.139||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Nausea and vomiting||2.139|0.568|0.791
71797734|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.487|TWO_SIDED|95.0|0.454|1.443||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Pain||1.443|0.454|0.487
71797735|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.014||||0.976|TWO_SIDED|95.0|0.556|1.85||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Dyspnoea||1.850|0.556|0.976
71797736|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.694||||0.111|TWO_SIDED|95.0|0.882|3.25||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Insomnia||3.250|0.882|0.111
71674270|NCT00927862|142867098|NON_INFERIORITY_OR_EQUIVALENCE|Based on power calculations and feasibility, the minimum recruitment target for the randomized, PG-guided comparison was set at 500 patients. All qualifying parallel control patients were included, anticipated to number ≥1000. For hypothesis 1, the power to exclude inferiority of the modified PG arm vs standard PG arm at a margin (delta) of 5% with 250 patients per group at a 2-sided alpha \<0.05 is 87%, assuming a common standard deviation of 0.20.|Mean Difference (Final Values)|0.34|STANDARD_DEVIATION|0.2|<|0.05|TWO_SIDED|95.0||||Comparisons between groups for primary endpoints were made using the unpaired T-test.|t-test, 2 sided|||Comparisons between groups for primary endpoints were made using the unpaired T-test. All consented, randomized patients who were successfully genotyped and received at least one dose of warfarin with at least one post-dose INR were included in efficacy analyses (modified intention to treat \[mITT\]).||||<0.05
71674271|NCT00820248|142867118|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.83|TWO_SIDED|95.0|0.6|1.5|||Regression, Cox||Hazard ratio of panitumumab vs cisplatin|The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.||1.50|0.60|0.83
71797737|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.108||||0.76|TWO_SIDED|95.0|0.62|1.979||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Appetite loss||1.979|0.620|0.760
71797738|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.119||||0.747|TWO_SIDED|95.0|0.586|2.135||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Constipation||2.135|0.586|0.747
71797739|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.367||||0.33|TWO_SIDED|95.0|0.726|2.576||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Diarrhoea||2.576|0.726|0.330
71797740|NCT02659020|143095060|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.411|TWO_SIDED|95.0|0.636|2.965||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Log Rank||Stratified by number of prior systemic therapies for locally advanced or metastatic disease (0 vs ≥1), histological tumor type (leiomyosarcoma vs non-leiomyosarcoma), and ECOG PS (0 vs1).|Financial difficulties||2.965|0.636|0.411
71797741|NCT04382911|143095063|EQUIVALENCE|A 2x2 table was constructed among all patients with histopathologically identified endometriosis (true positive) to compare sensitivity for FES PET/MRI versus sensitivity of conventional MRI.||||||0.317|||||||McNemar|||||||0.317
71797742|NCT04382911|143095066|OTHER|A random effects linear regression model, modeling SUV-max as a function of the pain rating, while controlling for patient-level covariates (BMI, race, age) was performed. The investigators included physician as a random effect to account for physician-level correlation.|Slope|0.748||||0.24|TWO_SIDED||||||Pearson's Correlation Coefficient|||||||0.24
71797743|NCT04382911|143095066|OTHER|The investigators will implement a random effects linear regression model, modeling SUV-max as a function of EHP-30, while controlling for patient-level covariates (BMI, race, age). The investigators will include physician as a random effect to account for physician-level correlation.|Slope|0.406||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71674272|NCT00820248|142867119|SUPERIORITY||Cox Proportional Hazard|0.89||||0.66|TWO_SIDED|95.0|0.54|1.48|||Log Rank||hazard ratio for panitumumab vs cisplatin|||1.48|0.54|0.66
71797744|NCT01120210|143095067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.0595|TWO_SIDED|90.0|-0.016|0.564|||ANCOVA|one-sided p-value and one-sided alpha=0.05||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose.||0.564|-0.016|0.0595
71797745|NCT01120210|143095067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33||||0.0215|TWO_SIDED|90.0|0.064|0.595||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 15 ng/kg/min dose.||0.595|0.064|0.0215
71797746|NCT01120210|143095067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.0049|TWO_SIDED|90.0|0.214|0.921||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 30 ng/kg/min dose.||0.921|0.214|0.0049
71797747|NCT01120210|143095068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.4729|TWO_SIDED|90.0|-2.312|2.131||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 5 ng/kg/min dose.||2.131|-2.312|0.4729
71797748|NCT01120210|143095068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.2123|TWO_SIDED|90.0|-4.164|1.464||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 15 ng/kg/min dose.||1.464|-4.164|0.2123
71797749|NCT01120210|143095068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.58||||0.0821|TWO_SIDED|90.0|-5.639|0.483||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 30 ng/kg/min dose.||0.483|-5.639|0.0821
71813396|NCT05375955|143129294|OTHER||Risk Difference (RD)|22.8||||0.0038|TWO_SIDED|95.0|6.3|40.4|||Chan and Zhang (1999) method|||Week 8||40.4|6.3|0.0038
71674273|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|-0.226|||||TWO_SIDED|||||||||leftIFG (Change in Brain activity \[post minus pre\])||||
71813397|NCT05375955|143129294|OTHER||Risk Difference (RD)|30.4||||0.0007|TWO_SIDED|95.0|12.2|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|12.2|0.0007
71813398|NCT05375955|143129294|OTHER||Risk Difference (RD)|21.5||||0.0146|TWO_SIDED|95.0|2.1|41.2|||Chan and Zhang (1999) method|||Week 10||41.2|2.1|0.0146
71797750|NCT01120210|143095069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7682|TWO_SIDED|95.0|-2.527|1.879||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 5 ng/kg/min dose.||1.879|-2.527|0.7682
71797751|NCT01120210|143095069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.4107|TWO_SIDED|95.0|-1.764|4.235||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 15 ng/kg/min dose.||4.235|-1.764|0.4107
71797752|NCT01120210|143095069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.1811|TWO_SIDED|95.0|-1.046|5.372||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 30 ng/kg/min dose.||5.372|-1.046|0.1811
71797753|NCT01120210|143095070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.803|TWO_SIDED|95.0|-6.06|4.718||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 5 ng/kg/min dose.||4.718|-6.060|0.8030
71797754|NCT01120210|143095070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.4923|TWO_SIDED|95.0|-7.781|3.801||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 15 ng/kg/min dose.||3.801|-7.781|0.4923
71797755|NCT01120210|143095070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77||||0.3152|TWO_SIDED|95.0|-11.251|3.708||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 30 ng/kg/min dose.||3.708|-11.251|0.3152
71797756|NCT01120210|143095071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36||||0.1561||95.0|-8.047|1.331||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 5 ng/kg/min dose.||1.331|-8.047|0.1561
71797757|NCT01120210|143095071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.55||||0.0282|TWO_SIDED|95.0|-10.482|-0.622||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 15 ng/kg/min dose.||-0.622|-10.482|0.0282
71797758|NCT01120210|143095071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.08||||0.0043|TWO_SIDED|95.0|-11.818|-2.332||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 30 ng/kg/min dose.||-2.332|-11.818|0.0043
71797759|NCT01120210|143095072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.9769|TWO_SIDED|95.0|-16.347|16.823||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min dose.||16.823|-16.347|0.9769
71797760|NCT01120210|143095073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.98||||0.8297|TWO_SIDED|95.0|-16.592|20.551||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEDV at the end of the 30 ng/kg/min dose.||20.551|-16.592|0.8297
71797761|NCT01120210|143095074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.865|TWO_SIDED|95.0|-3.352|3.968||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEF at the end of the 30 ng/kg/min dose.||3.968|-3.352|0.8650
71797762|NCT01120210|143095075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95||||0.3748|TWO_SIDED|95.0|-1.204|3.102||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in FS at the end of the 30 ng/kg/min dose.||3.102|-1.204|0.3748
71797763|NCT01120210|143095076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08||||0.2123|TWO_SIDED|95.0|-4.198|18.359||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 5 ng/kg/min dose.||18.359|-4.198|0.2123
71797764|NCT01120210|143095076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.78||||0.1083|TWO_SIDED|95.0|-2.016|19.575||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||19.575|-2.016|0.1083
71797765|NCT01120210|143095076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.16||||0.018|TWO_SIDED|95.0|2.557|25.771||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 30 ng/kg/min dose.||25.771|2.557|0.0180
71797766|NCT01120210|143095077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.4841|TWO_SIDED|95.0|-5.308|2.554||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 5 ng/kg/min dose.||2.554|-5.308|0.4841
71797767|NCT01120210|143095077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.6665|TWO_SIDED|95.0|-5.567|3.594||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.||3.594|-5.567|0.6665
71797768|NCT01120210|143095077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6904|TWO_SIDED|95.0|-4.107|6.148||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 30 ng/kg/min dose.||6.148|-4.107|0.6904
71797769|NCT01120210|143095078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.6304|TWO_SIDED|95.0|-2.197|3.588||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 5 ng/kg/min dose.||3.588|-2.197|0.6304
71813399|NCT05375955|143129294|OTHER||Risk Difference (RD)|19.7||||0.0205|TWO_SIDED|95.0|1.0|38.9|||Chan and Zhang (1999) method|||Week 10||38.9|1.0|0.0205
71674274|NCT04157296|142867129|SUPERIORITY||Median Difference (Final Values)|-0.309|||||TWO_SIDED|||||||||rightIFG (Change in Brain activity \[post minus pre\])||||
71797770|NCT01120210|143095078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.842|TWO_SIDED|95.0|-3.851|3.153||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 15 ng/kg/min dose.||3.153|-3.851|0.8420
71797771|NCT01120210|143095078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.6658|TWO_SIDED|95.0|-4.138|2.669||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 30 ng/kg/min dose.||2.669|-4.138|0.6658
71797772|NCT01120210|143095079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-264.36||||0.051|TWO_SIDED|95.0|-529.875|1.147||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 5 ng/kg/min dose.||1.147|-529.875|0.0510
71797773|NCT01120210|143095079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-383.32||||0.0006|TWO_SIDED|95.0|-592.781|-173.867||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 15 ng/kg/min dose.||-173.867|-592.781|0.0006
71797774|NCT01120210|143095079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-527.77||||0.0001|TWO_SIDED|95.0|-764.07|-291.478||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 30 ng/kg/min dose.||-291.478|-764.070|0.0001
71797775|NCT05320029|143095084|NON_INFERIORITY|If the two-side 95%CI limit of the difference between the two groups is greater than the non-inferiority margin of -10%, the non-inferiority hypothesis of this study is valid|Mean Difference (Final Values)|0.0|||<|0.05|TWO_SIDED|95.0|-0.0458|0.0458|||Newcombe-Wilson|||||0.0458|-0.0458|<0.05
71797776|NCT01494610|143095212|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.508|||||TWO_SIDED|90.0|1.366|1.665|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.665|1.366|
71797777|NCT01494610|143095212|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.598|||||TWO_SIDED|90.0|1.369|1.864|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.864|1.369|
71797778|NCT01494610|143095212|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.421|||||TWO_SIDED|90.0|1.274|1.584|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.584|1.274|
71797779|NCT01494610|143095213|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.928|||||TWO_SIDED|90.0|0.886|0.971|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.971|0.886|
71797780|NCT01494610|143095213|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.892|||||TWO_SIDED|90.0|0.848|0.939|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||0.939|0.848|
71813400|NCT05375955|143129294|OTHER||Risk Difference (RD)|39.7||||0.0002|TWO_SIDED|95.0|17.1|59.3|||Chan and Zhang (1999) method|||Week 10||59.3|17.1|0.0002
71813401|NCT05375955|143129294|OTHER||Risk Difference (RD)|12.6||||0.1245|TWO_SIDED|95.0|-7.8|32.6|||Chan and Zhang (1999) method|||Week 12||32.6|-7.8|0.1245
71813402|NCT05375955|143129294|OTHER||Risk Difference (RD)|11.0||||0.1431|TWO_SIDED|95.0|-9.1|31.5|||Chan and Zhang (1999) method|||Week 12||31.5|-9.1|0.1431
71813403|NCT05375955|143129294|OTHER||Risk Difference (RD)|36.8||||0.0007|TWO_SIDED|95.0|12.2|56.8|||Chan and Zhang (1999) method|||Week 12||56.8|12.2|0.0007
71813404|NCT05375955|143129295|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
71813405|NCT05375955|143129295|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
71674275|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|-0.179|||||TWO_SIDED|||||||||leftParietal (Change in Brain activity \[post minus pre\])||||
71674276|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|0.324|||||TWO_SIDED|||||||||rightParietal (Change in Brain activity \[post minus pre\])||||
71797781|NCT01494610|143095213|NON_INFERIORITY_OR_EQUIVALENCE|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.889|1.049|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.|||1.049|0.889|
71797782|NCT00384813|143095304|SUPERIORITY_OR_OTHER||regression coefficient|0.33||||0.23||||||For both baseline to 4 month analyses (see above p value) and baseline to 10 month analyses, the variable of intervention group did not contribute significant additional variance.|Regression, Linear|||||||0.23
71797783|NCT00167934|143095311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||< 0.0001
71797784|NCT00167934|143095312|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
71797785|NCT04951622|143095321|SUPERIORITY||Difference of LS Means|-1.45|STANDARD_ERROR_OF_MEAN|0.47|=|0.002|TWO_SIDED|95.0|-2.38|-0.52|||mixed effects model for repeated measure|||||-0.52|-2.38|=0.002
71797786|NCT04108208|143095350|SUPERIORITY||Hazard Ratio (HR)|0.233|||=|0.0052|TWO_SIDED|95.0|0.077|0.705|||Log Rank|||||0.705|0.077|=0.0052
71797787|NCT00409292|143095384|SUPERIORITY_OR_OTHER|||||||0.1|||||||binomial hypothesis test|||||||0.10
71674277|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||leftdACC (Change in Brain activity \[post minus pre\])||||
71797788|NCT00376168|143095390|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
71674278|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|-0.067|||||TWO_SIDED|||||||||rightdACC (Change in Brain activity \[post minus pre\])||||
71797789|NCT00376168|143095390|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||threshold for statistical significance = 0.025|one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."||||<0.0001
71797790|NCT00376168|143095391|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0041
71797791|NCT00376168|143095391|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
71674279|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|0.302|||||TWO_SIDED|||||||||leftInsula (Change in Brain activity \[post minus pre\])||||
71674280|NCT04157296|142867129|SUPERIORITY|rightInsula (Change in Brain activity \[post minus pre\])|Mean Difference (Final Values)|0.234|||||TWO_SIDED|||||||||rightInsula (Change in Brain activity \[post minus pre\])||||
71674281|NCT04157296|142867129|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|||||||||TCN (Change in Connectivity \[post minus pre\])||||
71674282|NCT04157296|142867130|SUPERIORITY|||||||0.241|||||||t-test, 1 sided|||||||0.241
71674283|NCT04157296|142867131|SUPERIORITY|||||||0.233|||||||t-test, 1 sided|||||||0.233
71674284|NCT04157296|142867132|SUPERIORITY|||||||0.042|||||||t-test, 1 sided|||||||0.042
71674285|NCT04157296|142867133|SUPERIORITY|||||||0.349|||||||t-test, 1 sided|||||||0.349
71813406|NCT05375955|143129295|OTHER||Risk Difference (RD)|4.9||||0.1705|TWO_SIDED|95.0|-6.1|17.6|||Chan and Zhang (1999) method|||Week 2||17.6|-6.1|0.1705
71813407|NCT05375955|143129295|OTHER||Risk Difference (RD)|7.3||||0.1118|TWO_SIDED|95.0|-3.9|20.5|||Chan and Zhang (1999) method|||Week 2||20.5|-3.9|0.1118
71813408|NCT05375955|143129295|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 4||20.5|-9.5|0.2751
71813409|NCT05375955|143129295|OTHER||Risk Difference (RD)|2.8||||0.3857|TWO_SIDED|95.0|-11.4|17.6|||Chan and Zhang (1999) method|||Week 4||17.6|-11.4|0.3857
71813410|NCT05375955|143129295|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
71813411|NCT05375955|143129295|OTHER||Risk Difference (RD)|7.5||||0.1429|TWO_SIDED|95.0|-6.4|22.6|||Chan and Zhang (1999) method|||Week 6||22.6|-6.4|0.1429
71813412|NCT05375955|143129295|OTHER||Risk Difference (RD)|9.8||||0.1119|TWO_SIDED|95.0|-4.4|25.3|||Chan and Zhang (1999) method|||Week 8||25.3|-4.4|0.1119
71813413|NCT05375955|143129295|OTHER||Risk Difference (RD)|2.7||||0.3755|TWO_SIDED|95.0|-10.7|16.7|||Chan and Zhang (1999) method|||Week 8||16.7|-10.7|0.3755
71813414|NCT05375955|143129295|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-8.4|0.2547
71813415|NCT05375955|143129295|OTHER||Risk Difference (RD)|2.9||||0.3928|TWO_SIDED|95.0|-12.7|18.6|||Chan and Zhang (1999) method|||Week 10||18.6|-12.7|0.3928
71813416|NCT05375955|143129296|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
71813417|NCT05375955|143129296|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|10.1|||Chan and Zhang (1999) method|||Week 1||10.1|-10.6|1.0000
71797792|NCT00376168|143095392|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0010
71674286|NCT02237196|142867134|SUPERIORITY||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.5038||0.314|TWO_SIDED|95.0|-1.51|0.49|||Longitudinal repeated measures analysis|Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)||||0.49|-1.51|0.314
71674287|NCT03980145|142867149|SUPERIORITY|||||||0.405||||||Statistical significance set at .05|ANOVA|||Null hypothesis is no difference between the two groups||||.405
71674288|NCT03980145|142867149|SUPERIORITY|||||||0.133|||||||ANOVA|||Null hypothesis is no difference between pretest and posttest||||.133
71674289|NCT03980145|142867149|SUPERIORITY|||||||0.05|||||||ANOVA|||Evaluated the difference between the pretest and posttest within the conventional physical therapy group||||.050
71674290|NCT03980145|142867149|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.017|TWO_SIDED|95.0|0.015|0.124||p value was adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Evaluating the impact of whether comfortable walking speed for both groups combined resulted in a significant improvement in walking speed||.124|.015|.017
71674291|NCT03980145|142867150|SUPERIORITY|||||||0.369|||||||ANOVA|||Comparison of the impact between the two arms looking an improved walking endurance||||.369
71797793|NCT00376168|143095392|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||<0.0001
71797794|NCT00376168|143095393|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0460
71840560|NCT04909801|143190290|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-0.1||||0.5248|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 113||0.2|-0.3|0.5248
71674292|NCT03980145|142867150|SUPERIORITY|||||||0.71|||||||ANOVA|||Evaluation of impact of end-effector robotic training alone||||.710
71797795|NCT00376168|143095393|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.||||0.0031
71840561|NCT04909801|143190290|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.1778|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 141||0.2|-0.3|0.1778
71674293|NCT03980145|142867150|SUPERIORITY|||||||0.682|||||||ANOVA|||Evaluating the impact of conventional therapy on walking endurance Null hypothesis is no difference between pretest and posttest||||.682
71797796|NCT02350309|143095395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.15||||0.0262|ONE_SIDED|95.0|-2.12|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-2.12|0.0262
71840562|NCT04909801|143190290|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.0||||0.851|TWO_SIDED|95.0|-0.3|0.2|||longitudinal|||Day 169||0.2|-0.3|0.8510
71840563|NCT04909801|143190291|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.3||||0.2319|TWO_SIDED|95.0|-0.9|3.5|||longitudinal|||Day 29||3.5|-0.9|0.2319
71674294|NCT03980145|142867150|SUPERIORITY|||||||0.568||||||p value adjusted for multiple comparisons - Bonferroni|ANOVA|||Evaluating the impact of whether both groups combined resulted in a significant change in walking distance||||.568
71674295|NCT03980145|142867151|SUPERIORITY|||||||0.594||||||Outcome specific to the physical domain|ANOVA|||Evaluation of the physical domain||||.594
71674296|NCT03980145|142867151|SUPERIORITY|||||||0.061|||||||ANOVA|||Pretest- Posttest End Effector Robotic Training Comparison for the Physical Domain||||.061
71674297|NCT03980145|142867151|SUPERIORITY|||||||0.812|||||||ANOVA|||Pretest posttest comparison of conventional training group for physical domain||||.812
71674298|NCT03980145|142867151|SUPERIORITY|||||||0.235|||||||ANOVA|||Combined conventional and end-effector training for outcomes in the physical domain||||.235
71674299|NCT03980145|142867151|SUPERIORITY|||||||0.465|||||||ANOVA|||Between group assessment of changes in the MFIS Cognitive domain||||.465
71674300|NCT03980145|142867151|SUPERIORITY|||||||0.165|||||||ANOVA|||Within group differences for the End Effector Robotic Training Group for the Cognitive Domain||||.165
71674301|NCT03980145|142867151|SUPERIORITY|||||||0.682|||||||ANOVA|||Within group assessment for the conventional group within the cognitive domain of the MFIS||||.682
71674302|NCT03980145|142867151|SUPERIORITY||Mean Difference (Final Values)|5.39||||0.017|TWO_SIDED|95.0|1.12|9.67||p value adjusted using a Bonferroni correction|ANOVA|||Combined group outcomes comparing pretest to posttest for the cognitive domain||9.67|1.12|.017
71674303|NCT03980145|142867151|SUPERIORITY|||||||0.052|||||||ANOVA|||Between group comparison for the MFIS Psychological Subscale||||.052
71674304|NCT03980145|142867151|SUPERIORITY|||||||0.483|||||||ANOVA|||Within group comparison for the end-effector robotic training group for the MFIS Psychological subscale||||.483
71674305|NCT03980145|142867151|SUPERIORITY|||||||0.056|||||||ANOVA|||Within group assessment for the conventional physical therapy group for the MFIS Psychological subscale||||.056
71674306|NCT03980145|142867151|SUPERIORITY||Mean Difference (Final Values)|1.313||||0.048|TWO_SIDED|95.0|0.016|2.619||p value is adjusted for multiple comparisons using a Bonferroni correction|ANOVA|||Change in MFIS for all subjects from pre to posttest for the psychological subscale||2.619|.016|.048
71840564|NCT04909801|143190291|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.5572|TWO_SIDED|95.0|-1.5|2.7|||longitudinal|||Day 57||2.7|-1.5|0.5572
71674307|NCT03980145|142867151|SUPERIORITY|||||||0.01|||||||ANOVA|||Between group assessment of differences in total score||||.010
71674308|NCT03980145|142867151|SUPERIORITY|||||||0.089|||||||ANOVA|||Within assessment of change in total fatigue score||||.089
71674309|NCT03980145|142867151|SUPERIORITY|||||||0.5|||||||ANOVA|||Within group assessment of change in total score||||.50
71674310|NCT03980145|142867151|SUPERIORITY||Mean Difference (Final Values)|9.464||||0.1|TWO_SIDED|95.0|2.678|16.251|||ANOVA|||Combined assessment of all subject improvement in total MFIS score||16.251|2.678|0.10
71674311|NCT03980145|142867152|SUPERIORITY|||||||0.071|||||||ANOVA|||Null hypothesis set for no difference between groups Assessment of between group differences for the physical subscale||||.071
71674312|NCT03980145|142867152|SUPERIORITY||Mean Difference (Final Values)|14.84||||0.005|TWO_SIDED|95.0|6.02|23.66|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||23.66|6.02|.005
71797797|NCT02350309|143095395|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.48|||<|0.0001|ONE_SIDED|95.0|-4.46|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||||-4.46|<0.0001
71797798|NCT02350309|143095396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0215||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||0.0215
71674313|NCT03980145|142867152|SUPERIORITY||Mean Difference (Final Values)|13.57||||0.001|TWO_SIDED|95.0|8.3|18.85|||ANOVA|||With group assessment of change on the physical subscale of the MSIS||18.85|8.30|.001
71674314|NCT03980145|142867152|SUPERIORITY||Mean Difference (Final Values)|14.21||||2.6e-05|TWO_SIDED|95.0|9.367|19.04||p value adjusted for multiple comparisons using Bonferroni|ANOVA|||Combined group assessment of change on the physical subscale of the MSIS||19.04|9.367|.000026
71674315|NCT03980145|142867152|SUPERIORITY|||||||0.084||||||Pretest measures were statistically different between the two groups|ANOVA|||Between group comparison for the psychological subscale for the MSIS||||.084
71797799|NCT02350309|143095396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
71797800|NCT02350309|143095396|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar|||||||<0.0001
71813418|NCT05375955|143129296|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
71674316|NCT03980145|142867152|SUPERIORITY|||||||0.412|||||||ANOVA|||Within group comparison for the psychological subscale for the MSIS||||.412
71674317|NCT03980145|142867152|SUPERIORITY||Mean Difference (Final Values)|22.22||||0.00018|TWO_SIDED|95.0|15.59|28.85|||ANOVA|||Within group comparison for the psychological subscale for the MSIS||28.85|15.59|.00018
71674318|NCT03980145|142867152|SUPERIORITY||Mean Difference (Final Values)|13.19||||0.00049|TWO_SIDED|95.0|7.013|19.38|||ANOVA|||Combined group comparison for the psychological subscale for the MSIS||19.38|7.013|.00049
71674319|NCT03980145|142867153|SUPERIORITY|||||||0.352|||||||ANOVA|||Null hypothesis is no difference between the two groups||||.352
71674320|NCT03980145|142867153|SUPERIORITY|||||||0.079|||||||ANOVA|||Within group assessment||||.079
71674321|NCT03980145|142867153|SUPERIORITY|||||||0.393|||||||ANOVA|||Within group assessment||||.393
71674322|NCT03980145|142867153|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.048|TWO_SIDED|95.0|0.001|0.116|||ANOVA|Adjusted for multiple mean comparisons||Evaluating the impact of whether fast walking speed for both groups combined resulted in a significant improvement in walking speed||.116|.001|.048
71674323|NCT03980145|142867154|SUPERIORITY|||||||0.117|||||||ANOVA|||Between group assessment for the HADS Anxiety Subscale||||.117
71674324|NCT03980145|142867154|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.041|TWO_SIDED|95.0|0.093|3.407|||ANOVA|||Within group assessment for HADS Anxiety Subscale||3.407|.093|.041
71674325|NCT03980145|142867154|SUPERIORITY|||||||0.15|||||||ANOVA|||Within group assessment for HADS Anxiety Subscale||||.150
71674326|NCT03980145|142867154|SUPERIORITY||Mean Difference (Final Values)|1.518||||0.012|TWO_SIDED|95.0|0.39|2.646||p value adjusted for multiple comparisons|ANOVA|||Combined group assessment of HADS Anxiety Subscale||2.646|.390|.012
71674327|NCT03980145|142867155|SUPERIORITY|||||||0.239|||||||ANOVA|||||||.239
71674328|NCT03980145|142867155|SUPERIORITY|||||||0.667|||||||ANOVA|||Comparison between groups for differences in sensory pain score||||.667
71674329|NCT03980145|142867155|SUPERIORITY|||||||0.77|||||||ANOVA|||Between group differences in affective pain||||.770
71674330|NCT03980145|142867156|SUPERIORITY|||||||0.136|||||||ANOVA|||Between group assessment of LLFDI Disability Frequency||||.136
71674331|NCT03980145|142867156|SUPERIORITY|||||||0.833|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Frequency||||.833
71674332|NCT03980145|142867156|SUPERIORITY||Mean Difference (Final Values)|6.996||||0.044|TWO_SIDED|95.0|0.212|13.781|||ANOVA|||Between Group Assessment of improvement in LLFDI Disability Limitations||13.781|.212|.044
71674333|NCT03980145|142867156|SUPERIORITY|||||||0.212|||||||ANOVA|||Combined group assessment of improvement in LLFDI Disability Limitations||||.212
71813419|NCT05375955|143129296|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
71813420|NCT05375955|143129296|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
71813421|NCT05375955|143129296|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
71813422|NCT05375955|143129296|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
71813423|NCT05375955|143129296|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
71813424|NCT05375955|143129296|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
71813425|NCT05375955|143129296|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
71674334|NCT03980145|142867157|SUPERIORITY|||||||0.338|||||||ANOVA|||Between group comparison for the LLDFI Function||||.338
71674335|NCT03980145|142867157|SUPERIORITY||Mean Difference (Final Values)|7.508||||0.007|TWO_SIDED|95.0|2.73|12.28|||ANOVA|||Within group assessment of LLFDI Function||12.28|2.73|.007
71674336|NCT03980145|142867157|SUPERIORITY|||||||0.067|||||||ANOVA|||Within group assessment for changes in LLFDI Function||||.067
71674337|NCT03980145|142867157|SUPERIORITY||Mean Difference (Final Values)|5.99||||0.001|TWO_SIDED|95.0|2.9|9.08||p value adjusted for multiple comparisons|ANOVA|||Combined group improvement in LLFDI Function||9.08|2.90|.001
71674338|NCT00862823|142867176|NON_INFERIORITY_OR_EQUIVALENCE|The sample size was determined so there was an 80% chance that a 90% pairwise interval for 2 equivalent formulations would satifsy the FDA criteria for AUC and Cmax of log (0.8), log (1.2).|Geometric Mean Ratio|0.97|||<|0.05||90.0||||Bioequivalent measurew were log-transformed|log transformation|||||||<0.05
71674339|NCT00863343|142867233|SUPERIORITY_OR_OTHER||Sensitivity|0.82|||||TWO_SIDED|95.0|0.59|0.94|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.94|0.59|
71840565|NCT04909801|143190291|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.1||||0.9366|TWO_SIDED|95.0|-2.0|2.1|||longitudinal|||Day 85||2.1|-2.0|0.9366
71674340|NCT00863343|142867233|SUPERIORITY_OR_OTHER||Specificity|0.987|||||TWO_SIDED|95.0|0.97|0.99|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.99|0.97|
71674341|NCT00863343|142867234|SUPERIORITY_OR_OTHER||Sensitivity|0.81|||||TWO_SIDED|95.0|0.63|0.92|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.92|0.63|
71674342|NCT00863343|142867234|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
71674343|NCT00863343|142867235|SUPERIORITY_OR_OTHER||Sensitivity|0.88|||||TWO_SIDED|95.0|0.7|0.96|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.96|0.70|
71674344|NCT00863343|142867235|SUPERIORITY_OR_OTHER||Specificity|0.997||||||95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
71674345|NCT00863343|142867236|SUPERIORITY_OR_OTHER||Sensitivity|0.79|||||TWO_SIDED|95.0|0.6|0.9|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||0.90|0.60|
71840566|NCT04909801|143190291|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1508|TWO_SIDED|95.0|-3.5|1.0|||longitudinal|||Day 113||1.0|-3.5|0.1508
71674346|NCT00863343|142867236|SUPERIORITY_OR_OTHER||Specificity|0.997|||||TWO_SIDED|95.0|0.98|1.0|||Wilson score method||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.|||1.0|0.98|
71674347|NCT01421225|142867237|EQUIVALENCE|The null hypothesis was that the number of hours would be the same (no effect of control).|Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|||||Statistical analysis was performed using a paired t-test.|t-test, 2 sided|||We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)||||0.12
71840567|NCT04909801|143190291|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0303|TWO_SIDED|95.0|-3.6|-0.2|||longitudinal|||Day 141||-0.2|-3.6|0.0303
71674348|NCT02049814|142867242|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established.||||||0.0001|||||||Paired t-test|||||||0.0001
71674349|NCT01322490|142867280|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.4742||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.4742
71674350|NCT01322490|142867280|SUPERIORITY|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.5885||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.||||||0.5885
71674351|NCT01322490|142867281|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.9588|||||TWO_SIDED|95.0|0.7144|1.2867|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2867|0.7144|
71674352|NCT01322490|142867281|SUPERIORITY|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.8941|||||TWO_SIDED|95.0|0.6647|1.2026|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.|||1.2026|0.6647|
71840568|NCT04909801|143190291|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.2333|TWO_SIDED|95.0|-3.3|0.8|||longitudinal|||Day 169||0.8|-3.3|0.2333
71840569|NCT04909801|143190292|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|1.9||||0.0938|TWO_SIDED|95.0|-0.3|4.2|||longitudinal|||Day 29||4.2|-0.3|0.0938
71674353|NCT01342523|142867289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.825|TWO_SIDED|95.0|0.88|1.17||P-value is not adjusted for multiple comparisons.|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.||1.17|0.88|.825
71674354|NCT01342523|142867289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.028|TWO_SIDED|95.0|1.02|1.36||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.||1.36|1.02|.028
71674355|NCT01342523|142867289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.755|TWO_SIDED|95.0|0.85|1.13||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.||1.13|0.85|.755
71674356|NCT01342523|142867289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.057|TWO_SIDED|95.0|0.996|1.33||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .||1.33|0.996|.057
71674357|NCT01342523|142867289|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.555||95.0|0.83|1.11||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.||1.11|0.83|.555
71674358|NCT02915705|142867341|SUPERIORITY||LS Mean Difference|1.14|||<|0.0001|TWO_SIDED|95.0|0.83|1.45|||ANCOVA|||Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.||1.45|0.83|< 0.0001
71674359|NCT02915705|142867342|SUPERIORITY||Odds Ratio (OR)|39.1|||<|0.0001|TWO_SIDED|95.0|7.2|211.7||Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|Regression, Logistic|||||211.7|7.2|< 0.0001
71674360|NCT02915705|142867343|SUPERIORITY||Odds Ratio (OR)|34.1||||0.0002|TWO_SIDED|95.0|5.6|206.3||Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.|generalized linear mixed model|||||206.3|5.6|0.0002
71674361|NCT02915705|142867344|SUPERIORITY||difference in LS means|1.02|||<|0.0001|TWO_SIDED|95.0|0.72|1.33|||GEE model|||Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.||1.33|0.72|< 0.0001
71674362|NCT02915705|142867345|SUPERIORITY||LS Mean Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.94||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|ANCOVA|||||-0.94|-1.74|< 0.0001
71674363|NCT02915705|142867346|SUPERIORITY||difference in LS means|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.83||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.|GEE model|||||-0.83|-1.59|< 0.0001
71674364|NCT02915705|142867347|SUPERIORITY||LS Mean Difference|0.4||||0.0162|TWO_SIDED|95.0|0.07|0.72||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||0.72|0.07|0.0162
71674365|NCT02915705|142867348|SUPERIORITY||difference in LS means|0.97|||<|0.0001|TWO_SIDED|95.0|0.57|1.37||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model|||||1.37|0.57|< 0.0001
71813426|NCT05375955|143129296|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
71813427|NCT05375955|143129296|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
71813428|NCT05375955|143129296|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
71813429|NCT05375955|143129296|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
71813430|NCT05375955|143129296|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
71813431|NCT05375955|143129296|OTHER||Risk Difference (RD)|9.3||||0.1256|TWO_SIDED|95.0|-6.6|26.4|||Chan and Zhang (1999) method|||Week 10||26.4|-6.6|0.1256
71813432|NCT05375955|143129296|OTHER||Risk Difference (RD)|25.5||||0.0038|TWO_SIDED|95.0|7.0|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|7.0|0.0038
71813433|NCT05375955|143129296|OTHER||Risk Difference (RD)|33.5||||0.0007|TWO_SIDED|95.0|12.8|52.6|||Chan and Zhang (1999) method|||Week 10||52.6|12.8|0.0007
71813434|NCT05375955|143129297|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
71674366|NCT02915705|142867349|SUPERIORITY||LS Mean Difference|0.12||||0.0408|TWO_SIDED|95.0|0.01|0.24|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.24|0.01|0.0408
71674367|NCT02915705|142867350|SUPERIORITY||difference in LS means|0.14||||0.049|TWO_SIDED|95.0|0.0|0.29|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.||0.29|0.00|0.0490
71674368|NCT02915705|142867351|SUPERIORITY||difference in LS means|1.02||||0.0386|TWO_SIDED|95.0|0.06|1.99|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.99|0.06|0.0386
71674369|NCT02915705|142867352|SUPERIORITY||difference in LS means|1.12||||0.0047|TWO_SIDED|95.0|0.37|1.88|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.||1.88|0.37|0.0047
71674370|NCT02915705|142867353|SUPERIORITY||difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.81|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||1.27|0.81|< 0.0001
71674371|NCT02915705|142867353|SUPERIORITY||difference|1.03|||<|0.0001|TWO_SIDED|95.0|0.79|1.27|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||1.27|0.79|< 0.0001
71840570|NCT04909801|143190292|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.6||||0.6053|TWO_SIDED|95.0|-1.6|2.7|||longitudinal|||Day 57||2.7|-1.6|0.6053
71840571|NCT04909801|143190292|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|0.2||||0.857|TWO_SIDED|95.0|-1.9|2.3|||longitudinal|||Day 85||2.3|-1.9|0.8570
71896268|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|4.657||||0.005|TWO_SIDED|95.0|1.584|13.686||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||13.686|1.584|0.005
71896269|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|2.478||||0.114|TWO_SIDED|95.0|0.805|7.632||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.632|0.805|0.114
71674372|NCT02915705|142867353|SUPERIORITY||difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.97|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||0.97|0.58|< 0.0001
71674373|NCT02915705|142867353|SUPERIORITY||difference|0.63|||<|0.0001|TWO_SIDED|95.0|0.44|0.81|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||0.81|0.44|< 0.0001
71674374|NCT02915705|142867353|SUPERIORITY||difference|0.51|||<|0.0001|TWO_SIDED|95.0|0.3|0.72|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||0.72|0.30|< 0.0001
71674375|NCT02915705|142867353|SUPERIORITY||difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.51|0.89|||GEE model|||Week 32||0.89|0.51|< 0.0001
71896270|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|3.499||||0.026|TWO_SIDED|95.0|1.16|10.555||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.555|1.160|0.026
71674376|NCT02915705|142867353|SUPERIORITY||difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.91|||GEE model||Difference (burosumab - Oral Phosphate/Active Vitamin D)|Week 40||0.91|0.51|< 0.0001
71840572|NCT04909801|143190292|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.2||||0.1592|TWO_SIDED|95.0|-3.0|0.5|||longitudinal|||Day 113||0.5|-3.0|0.1592
71840573|NCT04909801|143190292|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.9||||0.0319|TWO_SIDED|95.0|-3.7|-0.2|||longitudinal|||Day 141||-0.2|-3.7|0.0319
71840574|NCT04909801|143190292|SUPERIORITY|Abatacept - Adalimumab|Adjusted Mean Difference|-1.3||||0.2059|TWO_SIDED|95.0|-3.4|0.7|||longitudinal|||Day 169||0.7|-3.4|0.2059
71674377|NCT02915705|142867353|SUPERIORITY||difference|0.61|||<|0.0001|TWO_SIDED|95.0|0.39|0.82|||GEE model|||Week 52||0.82|0.39|< 0.0001
71674378|NCT02915705|142867353|SUPERIORITY||difference|0.69|||<|0.0001|TWO_SIDED|95.0|0.49|0.9|||GEE model|||Week 64||0.90|0.49|< 0.0001
71674379|NCT02915705|142867355|SUPERIORITY||difference in LS means|0.74|||<|0.0001|TWO_SIDED|95.0|0.58|0.91|||ANCOVA||Difference (KRN23 - Oral Phosphate/Active Vitamin D)|||0.91|0.58|< 0.0001
71674380|NCT02915705|142867358|SUPERIORITY||difference|48.27|||<|0.0001|TWO_SIDED|95.0|36.53|60.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 1||60.02|36.53|< 0.0001
71674381|NCT02915705|142867358|SUPERIORITY||difference|21.09|||<|0.0001|TWO_SIDED|95.0|12.01|30.16|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||30.16|12.01|< 0.0001
71674382|NCT02915705|142867358|SUPERIORITY||difference|15.75||||0.001|TWO_SIDED|95.0|6.35|25.15|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||25.15|6.35|0.0010
71674383|NCT02915705|142867358|SUPERIORITY||difference|12.97||||0.0078|TWO_SIDED|95.0|3.41|22.53|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||22.53|3.41|0.0078
71674384|NCT02915705|142867358|SUPERIORITY||difference|10.89||||0.0101|TWO_SIDED|95.0|2.59|19.19|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||19.19|2.59|0.0101
71674385|NCT02915705|142867358|SUPERIORITY||difference|6.23||||0.1165|TWO_SIDED|95.0|-1.55|14.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 32||14.02|-1.55|0.1165
71840575|NCT05875467|143190330|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||.042
71840576|NCT05875467|143190331|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||.928
71840577|NCT05875467|143190332|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||.022
71840578|NCT05875467|143190333|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
71674386|NCT02915705|142867358|SUPERIORITY||difference|11.21||||0.0317|TWO_SIDED|95.0|0.98|21.44|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||21.44|0.98|0.0317
71797801|NCT02114879|143095455|SUPERIORITY|||||||0.007||||||The p-value refers to the time by group interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Marginal Model|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.007
71797802|NCT02114879|143095456|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71797803|NCT02114879|143095457|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71797804|NCT02114879|143095458|SUPERIORITY|||||||0.96||||||The p-value refers to the time by group interaction. The statistical significance in this test was p\<0.05.|Mixed Models Analysis|||This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).||||0.96
71797805|NCT02114879|143095459|SUPERIORITY|||||||0.37||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Discharged Home Vs Discharged to Institution and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.37
71797806|NCT02114879|143095460|SUPERIORITY|||||||0.85||||||The p-value is calculated from a 2x2 Contingency Table consisting of rows that represent Yes/No Rehospitalization and columns that represent the EMR and SOC groups.|Chi-squared|||||||0.85
71797807|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Percentage of participants|29.0|||||TWO_SIDED|90.0|17.2|43.3|||||The estimated value represents the percentage of participants with CR and PR.|||43.3|17.2|
71797808|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Percentage of participants|45.0|||||TWO_SIDED|90.0|30.9|59.3|||||The estimated value represents the percentage of participants with CR and PR.|||59.3|30.9|
71797809|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Percentage of participants|47.0|||<|0.001|TWO_SIDED|90.0|32.8|62.1||Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.|||62.1|32.8|<0.001
71797810|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Percentage of participants|31.0|||||TWO_SIDED|90.0|11.3|57.3|||||The estimated value represents the percentage of participants with CR and PR.|||57.3|11.3|
71797811|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Percentage of participants|58.0|||<|0.001|TWO_SIDED|90.0|43.3|71.5||Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.|||71.5|43.3|<0.001
71797812|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.485|TWO_SIDED|90.0|-8.3|29.7|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||29.7|-8.3|0.485
71797813|NCT00558103|143095461|SUPERIORITY_OR_OTHER||Difference in percentage of participants|27.0||||0.116|TWO_SIDED|90.0|2.3|52.0|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.|||52.0|2.3|0.116
71797814|NCT03993938|143095470|OTHER|Delta PVI percentage change and Delta LAP (v-wave) percentage change were correlated using Spearman's rank correlation - two-tailed.|Spearman's rank correlation|0.34||||0.066|TWO_SIDED||||||Spearman's rank correlation|||||||0.066
71797815|NCT01276314|143095494|OTHER|||||||0.01||||||The p-value was analyzed for SJS/TEN participants with \>10% body surface area detachment.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.01
71797816|NCT01276314|143095494|OTHER|||||||0.06||||||This p-value was analyzed for DRESS participants.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.||||0.06
71797817|NCT00958776|143095535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.973|TWO_SIDED|95.0|0.69|1.55|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.55|0.69|0.973
71797818|NCT00958776|143095537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.558|TWO_SIDED|95.0|0.75|1.72|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.72|0.75|0.558
71797819|NCT00958776|143095538|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.633|TWO_SIDED|95.0|0.59|1.31|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||1.31|0.59|0.633
71797820|NCT00958776|143095539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.747|TWO_SIDED|95.0|0.92|2.32|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.|||2.32|0.92|0.747
71797821|NCT00958776|143095541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.303|TWO_SIDED|95.0|0.41|2.98|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio is calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at baseline, use of supplemental oxygen at baseline, influenza season, and influenza type.|||2.98|0.41|0.303
71674387|NCT02915705|142867358|SUPERIORITY||difference|5.01||||0.3044|TWO_SIDED|95.0|-4.55|14.56|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||14.56|-4.55|0.3044
71840579|NCT05192109|143190362|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
71840580|NCT05192109|143190362|OTHER|||||||0.93||||||This is the p-value for the simple effect of diagnostic group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.93
71840581|NCT05192109|143190362|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
71840582|NCT05192109|143190363|OTHER||||||<|0.01||||||This is the p-value for the simple effect of condition.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
71840583|NCT05192109|143190363|OTHER|||||||0.22||||||This is the p-value for the simple effect of group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||0.22
71674388|NCT02915705|142867358|SUPERIORITY||difference|8.7||||0.0145|TWO_SIDED|95.0|1.72|15.68|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D|Week 64||15.68|1.72|0.0145
71674389|NCT02915705|142867360|SUPERIORITY||difference|1.65|||<|0.0001|TWO_SIDED|95.0|1.28|2.02|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 4||2.02|1.28|< 0.0001
71797822|NCT00958776|143095543|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.768
71797823|NCT00958776|143095544|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.||||||0.758
71797824|NCT02583256|143095553|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
71797825|NCT02583256|143095553|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
71797826|NCT02583256|143095553|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
71797827|NCT02583256|143095553|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.18|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
71797828|NCT02583256|143095554|SUPERIORITY|Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.||1.3|1.1|
71797829|NCT02583256|143095554|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|0.93|||||TWO_SIDED|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.||1.0|0.9|
71797830|NCT02583256|143095554|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.||1.3|1.1|
71840584|NCT05192109|143190363|OTHER||||||<|0.01||||||This is the p-value for the interaction between condition and group.|Regression, Linear|||The primary statistical analysis involves asking whether children's preference to look at the target is significantly greater in one condition and/or group than the other. Mixed-effects regression analyses are used with the proportion-empirical-logit transformed-of target looking as the dependent measure, participant as random effect, and condition and group and their interaction as fixed effects.||||<0.01
71797831|NCT02583256|143095554|SUPERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.||1.3|1.1|
71797832|NCT02583256|143095555|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.28|1.51||||||Comparison performed for strain A/H1N1.||1.51|1.28|
71797833|NCT02583256|143095555|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.99|1.14||||||Comparison performed for strain A/H3N2||1.14|0.99|
71674390|NCT02915705|142867360|SUPERIORITY||difference|1.42|||<|0.0001|TWO_SIDED|95.0|1.19|1.64|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 8||1.64|1.19|< 0.0001
71674391|NCT02915705|142867360|SUPERIORITY||difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.84|1.48|||GEE model|||Week 16||1.48|0.84|< 0.0001
71674392|NCT02915705|142867360|SUPERIORITY||difference|1.11|||<|0.0001|TWO_SIDED|95.0|0.8|1.41|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||1.41|0.80|< 0.0001
71797834|NCT02583256|143095555|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.27|1.58||||||Comparison performed for strain B/Yamagata.||1.58|1.27|
71896271|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|3.943||||0.012|TWO_SIDED|95.0|1.348|11.534||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||11.534|1.348|0.012
71797835|NCT02583256|143095555|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.22|1.51||||||Comparison performed for strain B/Victoria.||1.51|1.22|
71797836|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||TWO_SIDED|95.0|1.07|1.32||||||Comparison performed for strain A/H1N1.||1.32|1.07|
71797837|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09||||||Comparison performed for strain A/H3N2.||1.09|0.90|
71797838|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.12|||||TWO_SIDED|95.0|1.01|1.25||||||Comparison performed for strain B/Yamagata.||1.25|1.01|
71797839|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.27||||||Comparison performed for strain B/Victoria.||1.27|0.98|
71797840|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.3|1.5||||||Comparison performed for strain A/H1N1.||1.5|1.3|
71797841|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.1||||||Comparison performed for strain A/H3N2.||1.1|0.9|
71797842|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.3|||||TWO_SIDED|95.0|1.2|1.4||||||Comparison performed for strain B/Yamagata.||1.4|1.2|
71797843|NCT02583256|143095556|NON_INFERIORITY|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.32|||||TWO_SIDED|95.0|1.2|1.5||||||Comparison performed for strain B/Victoria.||1.5|1.2|
71797844|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|1.8|||||TWO_SIDED|95.0|-4.9|8.6||||||Comparison performed for strain A/H1N1.||8.6|-4.9|
71797845|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|0.9|||||TWO_SIDED|95.0|-5.6|7.3||||||Comparison performed for strain A/H3N2.||7.3|-5.6|
71797846|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|4.3|||||TWO_SIDED|95.0|-1.8|10.4||||||Comparison performed for strain B/Yamagata.||10.4|-1.8|
71797847|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|2.6|||||TWO_SIDED|95.0|-3.3|8.5||||||Comparison performed for strain B/Victoria.||8.5|-3.3|
71797848|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|9.67|||||TWO_SIDED|95.0|3.11|16.17||||||Comparison performed for strain A/H1N1.||16.17|3.11|
71797849|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|-3.95|||||TWO_SIDED|95.0|-10.02|2.15||||||Comparison performed for strain A/H3N2.||2.15|-10.02|
71797850|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|12.95|||||TWO_SIDED|95.0|6.73|19.12||||||Comparison performed for strain B/Yamagata.||19.12|6.73|
71797851|NCT02583256|143095557|NON_INFERIORITY|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|8.36|||||TWO_SIDED|95.0|2.17|14.54||||||Comparison performed for strain B/Victoria.||14.54|2.17|
71797852|NCT02530294|143095598|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71797853|NCT02530294|143095599|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||<0.001
71797854|NCT02530294|143095600|OTHER||||||<|0.001|||||||ANCOVA|Ranked ANCOVA||||||< 0.001
71797855|NCT02530294|143095601|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71797856|NCT02530294|143095602|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71797857|NCT04027218|143095603|SUPERIORITY||Odds Ratio (OR)|2.57||||0.001|TWO_SIDED|95.0|2.34|2.79|||McNemar|||||2.79|2.34|0.001
71797858|NCT04027218|143095603|SUPERIORITY||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.7|2.13|||McNemar|||||2.13|1.70|0.002
71797859|NCT04027218|143095603|SUPERIORITY||Odds Ratio (OR)|1.9||||0.004|TWO_SIDED|95.0|1.87|1.92|||McNemar|||||1.92|1.87|0.004
71797860|NCT04027218|143095604|SUPERIORITY||Median Difference (Net)|-4.179||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
71797861|NCT04027218|143095604|SUPERIORITY||Median Difference (Net)|-3.619||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
71797862|NCT04027218|143095604|SUPERIORITY||Median Difference (Net)|-4.099||||0|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.000
71797863|NCT04027218|143095605|SUPERIORITY||Median Difference (Net)|-1.073||||0.863|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.863
71797864|NCT04027218|143095605|SUPERIORITY||Median Difference (Net)|-1.267||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.205
71797865|NCT04027218|143095605|SUPERIORITY||Median Difference (Net)|-0.858||||0.391|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.|||||0.391
71797866|NCT04027218|143095607|SUPERIORITY||Median Difference (Net)|-0.672||||0.502|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.502
71797867|NCT04027218|143095607|SUPERIORITY||Median Difference (Net)|-0.327||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.744
71813435|NCT05375955|143129297|OTHER||Risk Difference (RD)|2.5||||0.3269|TWO_SIDED|95.0|-8.4|14.1|||Chan and Zhang (1999) method|||Week 1||14.1|-8.4|0.3269
71797868|NCT04027218|143095607|SUPERIORITY||Median Difference (Net)|-1.885||||0.059|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.|||||0.059
71797869|NCT01948375|143095609|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71797870|NCT01948375|143095611|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.007||95.0|1.26|4.4||For the comparison of direct effect of placebo needle and real needle, p=0.007|Generalized Estimating Equation|||||4.40|1.26|0.007
71797871|NCT01948375|143095612|SUPERIORITY_OR_OTHER||||||=|0.006||||||"for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.~t=-2.88 refers to the t value of t test."|t-test, 2 sided|||||||=0.006
71797872|NCT01948375|143095613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||=|0.048||95.0|1.01|2.64||For the comparison of direct effect of placebo needle and real needle, p=0.048|Generalized Estimating Equation|||||2.64|1.01|=0.048
71797873|NCT03019627|143095616|SUPERIORITY||difference in least square means|-3.83|||=|0.428|TWO_SIDED|95.0|-13.34|5.68|||ANCOVA|||Frequency statistical analysis||5.68|-13.34|=0.428
71797874|NCT03019627|143095616|SUPERIORITY||difference in least square means|0.16|||=|0.974|TWO_SIDED|95.0|-9.45|9.76|||ANCOVA|||Severity statistical analysis||9.76|-9.45|=0.974
71797875|NCT03019627|143095617|SUPERIORITY||Difference in least square means|-1.12|||=|0.783|TWO_SIDED|95.0|-9.14|6.91|||ANCOVA|||frequency statistical analysis - week 4||6.91|-9.14|=0.783
71797876|NCT03019627|143095617|SUPERIORITY||difference in least square means|-3.82|||=|0.461|TWO_SIDED|95.0|-14.1|6.41|||ANCOVA|||Frequency statistical analysis - week 8||6.41|-14.1|=0.461
71797877|NCT03019627|143095617|SUPERIORITY||difference in least square means|-15.3|||=|0.004|TWO_SIDED|95.0|-25.6|-4.97|||ANCOVA|||Frequency statistical analysis - week 12||-4.97|-25.6|=0.004
71797878|NCT03019627|143095617|SUPERIORITY||difference in least square means|2.55|||=|0.544|TWO_SIDED|95.0|-5.72|10.82|||ANCOVA|||Severity statistical analysis - week 4||10.82|-5.72|=0.544
71797879|NCT03019627|143095617|SUPERIORITY||difference in least square means|1.06|||=|0.837|TWO_SIDED|95.0|-9.12|11.24|||ANCOVA|||Severity statistical analysis - week 8||11.24|-9.12|=0.837
71797880|NCT03019627|143095617|SUPERIORITY||difference in least square means|-13.8|||=|0.007|TWO_SIDED|95.0|-23.7|3.88|||ANCOVA|||Severity statistical analysis - week 12||3.88|-23.7|=0.007
71797881|NCT03019627|143095618|SUPERIORITY||Difference in least square means|-0.7|||=|0.046|TWO_SIDED|95.0|-1.38|-0.01|||ANCOVA|||week 4||-0.01|-1.38|=0.046
71797882|NCT03019627|143095618|SUPERIORITY||Difference in least square means|-0.3|||=|0.425|TWO_SIDED|95.0|-1.05|0.44|||ANCOVA|||week 8||0.44|-1.05|=0.425
71797883|NCT03019627|143095618|SUPERIORITY||Difference in least square means|-0.09|||=|0.788|TWO_SIDED|95.0|-0.76|0.58|||ANCOVA|||week 12||0.58|-0.76|=0.788
71797884|NCT03019627|143095619|SUPERIORITY||Difference in least square means|-0.71|||=|0.265|TWO_SIDED|95.0|-1.95|0.54|||ANCOVA|||week 4||0.54|-1.95|=0.265
71797885|NCT03019627|143095619|SUPERIORITY||Difference in least square means|-1.38|||=|0.026|TWO_SIDED|95.0|-2.59|-0.17|||ANCOVA|||week 8||-0.17|-2.59|=0.026
71797886|NCT03019627|143095619|SUPERIORITY||Difference in least square means|-0.6|||=|0.361|TWO_SIDED|95.0|-1.9|0.7|||ANCOVA|||week 12||0.70|-1.90|=0.361
71797887|NCT03019627|143095620|SUPERIORITY||Difference in least square means|-0.25|||=|0.323|TWO_SIDED|95.0|-0.76|0.25|||ANCOVA|||week 4||0.25|-0.76|=0.323
71797888|NCT03019627|143095620|SUPERIORITY||Difference in least square means|0.03|||=|0.908|TWO_SIDED|95.0|-0.55|0.62|||ANCOVA|||week 8||0.62|-0.55|=0.908
71797889|NCT03019627|143095620|SUPERIORITY||Difference in least square means|-0.12|||=|0.702|TWO_SIDED|95.0|-0.76|0.52|||ANCOVA|||week 12||0.52|-0.76|=0.702
71797890|NCT03019627|143095621|SUPERIORITY||Difference in least square means|5.75|||=|0.003|TWO_SIDED|95.0|2.02|9.48|||ANCOVA|||||9.48|2.02|=0.003
71797891|NCT02103478|143095642|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.144|||||TWO_SIDED|95.0|-3.165|2.876|||||Course 1|||2.876|-3.165|
71797892|NCT02103478|143095642|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.087|||||TWO_SIDED|95.0|-3.463|3.288|||||Course 2|||3.288|-3.463|
71797893|NCT02103478|143095642|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-2.588|||||TWO_SIDED|95.0|-6.074|0.899|||||Course 1|||0.899|-6.074|
71797894|NCT02103478|143095642|EQUIVALENCE|The 95% confidence intervals for the difference (oral - IV) were generated using an ANOVA model separately for Course 1 and Course 2.|Mean Difference (Final Values)|-0.096|||||TWO_SIDED|95.0|-5.08|4.888|||||Course 2|||4.888|-5.080|
71797895|NCT05107128|143095686|SUPERIORITY||Difference in Least Square (LS) Means|-1.1|STANDARD_ERROR_OF_MEAN|0.81||0.1675|TWO_SIDED|95.0|-2.7|0.5||The p-value was obtained from Mixed Model for Repeated Measures (MMRM) model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.5|-2.7|0.1675
71797896|NCT05107128|143095687|SUPERIORITY||Difference in LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.4872|TWO_SIDED|95.0|-2.4|1.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and UHDRS - Independence Scale at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||1.1|-2.4|0.4872
71813436|NCT05375955|143129297|OTHER||Risk Difference (RD)|2.6||||0.3585|TWO_SIDED|95.0|-9.2|15.5|||Chan and Zhang (1999) method|||Week 2||15.5|-9.2|0.3585
71813437|NCT05375955|143129297|OTHER||Risk Difference (RD)|7.4||||0.129|TWO_SIDED|95.0|-5.3|22.1|||Chan and Zhang (1999) method|||Week 2||22.1|-5.3|0.1290
71813438|NCT05375955|143129297|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 4||22.1|-10.7|0.2751
71813439|NCT05375955|143129297|OTHER||Risk Difference (RD)|7.7||||0.2547|TWO_SIDED|95.0|-8.4|24.3|||Chan and Zhang (1999) method|||Week 4||24.3|-8.4|0.2547
71813440|NCT05375955|143129297|OTHER||Risk Difference (RD)|5.2||||0.2751|TWO_SIDED|95.0|-9.5|20.5|||Chan and Zhang (1999) method|||Week 6||20.5|-9.5|0.2751
71813441|NCT05375955|143129297|OTHER||Risk Difference (RD)|12.3||||0.0658|TWO_SIDED|95.0|-3.8|28.8|||Chan and Zhang (1999) method|||Week 6||28.8|-3.8|0.0658
71840585|NCT02709161|143190433|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71674393|NCT02915705|142867360|SUPERIORITY||difference|1.24|||<|0.0001|TWO_SIDED|95.0|0.98|1.51|||GEE model|||Week 32||1.51|0.98|< 0.0001
71797897|NCT05107128|143095688|SUPERIORITY||Difference in LS Means|-5.0|STANDARD_ERROR_OF_MEAN|6.04||0.4089|TWO_SIDED|95.0|-17.0|6.9||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and SDMT score at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||6.9|-17.0|0.4089
71797898|NCT05107128|143095689|SUPERIORITY||Difference in LS Means|0.7|STANDARD_ERROR_OF_MEAN|1.26||0.5766|TWO_SIDED|95.0|-1.78|3.19||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and a baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||3.19|-1.78|0.5766
71797899|NCT05107128|143095690|SUPERIORITY||Difference in LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.64||0.1777|TWO_SIDED|95.0|-2.13|0.39||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and baseline value as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.39|-2.13|0.1777
71797900|NCT05107128|143095691|SUPERIORITY||Difference in LS Means|3.9|STANDARD_ERROR_OF_MEAN|1.76||0.0291|TWO_SIDED|95.0|0.4|7.3||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and Hi-DEF at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||7.3|0.4|0.0291
71797901|NCT05107128|143095692|SUPERIORITY||Difference in LS Means|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2923|TWO_SIDED|95.0|-0.3|0.1||The p-value was obtained from MMRM model which includes treatment, visit, treatment-by-visit interaction as categorical covariates, and CGI at baseline as a continuous covariate.|MMRM||Difference was calculated as SAGE-718 - placebo.|||0.1|-0.3|0.2923
71797902|NCT04988295|143095715|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.56|||Log Rank|||||0.56|0.35|<0.0001
71797903|NCT04988295|143095715|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|0.0001||95.0|0.36|0.64|||Log Rank|||||0.64|0.36|<0.0001
71840586|NCT02709161|143190434|SUPERIORITY||Mean Difference (Final Values)|8.2|||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71840587|NCT03257410|143190454|SUPERIORITY||Mean Difference (Final Values)|14.828|||||TWO_SIDED|95.0|10.501|19.156|||||Method=ANCOVA|If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is \> 0 then superiority will be demonstrated.||19.156|10.501|
71840588|NCT03257410|143190455|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the mean estimated treatment difference between Theranova 400 and Elisio 17H is \> -0.1765 g/dL then non-inferiority can be claimed. If the lower bound of the two-sided 95% confidence interval is \> 0, then superiority may be concluded.|Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.098|0.069|||ANCOVA|||||0.069|-0.098|
71674394|NCT02915705|142867360|SUPERIORITY||difference|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||1.60|1.10|< 0.0001
71797904|NCT05358821|143095750|SUPERIORITY||Mean Difference|3.3657|STANDARD_ERROR_OF_MEAN|0.2539|<|0.0001|TWO_SIDED|95.0|2.8566|3.8749|||T-test||Difference was calculated as HP - HD.|||3.8749|2.8566|<0.0001
71797905|NCT02504372|143095754|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.96|||||HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.96|0.68|
71797906|NCT02504372|143095755|OTHER||Hazard Ratio (HR)|0.83||||0.13499|TWO_SIDED|95.0|0.59|1.16|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||1.16|0.59|0.13499
71797907|NCT02504372|143095756|OTHER||Hazard Ratio (HR)|0.78||||0.01327|TWO_SIDED|95.0|0.62|0.97|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.97|0.62|0.01327
71797908|NCT02504372|143095763|OTHER||Hazard Ratio (HR)|0.76||||0.00143|TWO_SIDED|95.0|0.63|0.91|||Regression, Cox|One-sided p-value was based on the permutation test with multivariate Cox regression model.|HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.|||0.91|0.63|0.00143
71797909|NCT03901963|143095764|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.0001|TWO_SIDED|95.0|2.37|8.57||Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'|stratified Cochran-Mantel-Haenszel (CMH)||Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.|||8.57|2.37|<0.0001
71797910|NCT05429203|143095783|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.8
71797911|NCT05429203|143095784|OTHER|||||||1||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||1
71797912|NCT05429203|143095785|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
71797913|NCT05429203|143095786|OTHER|||||||0.4||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.4
71797914|NCT05429203|143095787|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
71797915|NCT05429203|143095788|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
71797916|NCT05429203|143095789|OTHER|||||||0.7||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.7
71797917|NCT05429203|143095790|OTHER|||||||0.6||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.6
71840589|NCT03257410|143190456|OTHER||Mean Difference (Final Values)|19.42|STANDARD_ERROR_OF_MEAN|2.103|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||<0.0001
71840590|NCT03257410|143190456|OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|2.115|<|0.0001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||<0.0001
71840591|NCT03257410|143190457|OTHER||Mean Difference (Final Values)|25.07|STANDARD_ERROR_OF_MEAN|4.3|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
71840592|NCT03257410|143190457|OTHER||Mean Difference (Final Values)|23.54|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
71840593|NCT03257410|143190458|OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|2.73|<|0.0001|TWO_SIDED||||||MMRM|||Week 4||||<0.0001
71840594|NCT03257410|143190458|OTHER||Mean Difference (Final Values)|15.36|STANDARD_ERROR_OF_MEAN|2.479|<|0.0001|TWO_SIDED||||||MMRM|||Week 24||||<0.0001
71840595|NCT03257410|143190459|OTHER||Mean Difference (Final Values)|17.59|STANDARD_ERROR_OF_MEAN|9.583||0.0684|TWO_SIDED||||||MMRM|||Week 4||||0.0684
71840596|NCT03257410|143190459|OTHER||Mean Difference (Final Values)|13.98|STANDARD_ERROR_OF_MEAN|7.937||0.0806|TWO_SIDED||||||MMRM|||Week 24||||0.0806
71840597|NCT03257410|143190464|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.0347|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0347
71840598|NCT03257410|143190464|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.033||0.0036|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.0036
71840599|NCT03257410|143190464|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.129
71840600|NCT03257410|143190464|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.052||0.1149|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.1149
71840601|NCT03257410|143190464|OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.044||0.0688|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.0688
71840602|NCT03257410|143190464|OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.042||0.6097|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.6097
71840603|NCT03257410|143190465|OTHER||Mean Difference (Final Values)|-6.32|STANDARD_ERROR_OF_MEAN|4.336||0.1472|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1472
71840604|NCT03257410|143190465|OTHER||Mean Difference (Final Values)|-11.18|STANDARD_ERROR_OF_MEAN|7.154||0.1207|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1207
71840605|NCT03257410|143190466|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.488||0.9775|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9775
71840606|NCT03257410|143190466|OTHER||Mean Difference (Final Values)|1.72|STANDARD_ERROR_OF_MEAN|2.905||0.5538|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.5538
71840607|NCT03257410|143190467|OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.146||0.11|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.1100
71840608|NCT03257410|143190467|OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4607|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.4607
71840609|NCT03257410|143190468|OTHER||Mean Difference (Final Values)|-0.0787|STANDARD_ERROR_OF_MEAN|0.04454||0.0791|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 4||||0.0791
71840610|NCT03257410|143190468|OTHER||Mean Difference (Final Values)|-0.0027|STANDARD_ERROR_OF_MEAN|0.04302||0.9505|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 8||||0.9505
71840611|NCT03257410|143190468|OTHER||Mean Difference (Final Values)|-0.0615|STANDARD_ERROR_OF_MEAN|0.04271||0.1521|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.1521
71840612|NCT03257410|143190468|OTHER||Mean Difference (Final Values)|0.0538|STANDARD_ERROR_OF_MEAN|0.04652||0.2489|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 16||||0.2489
71840613|NCT03257410|143190468|OTHER||Mean Difference (Final Values)|-0.0345|STANDARD_ERROR_OF_MEAN|0.05025||0.4936|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 20||||0.4936
71840614|NCT03257410|143190468|OTHER||Mean Difference (Final Values)|-0.0663|STANDARD_ERROR_OF_MEAN|0.0458||0.1497|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.1497
71840615|NCT03257410|143190469|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|2.012||0.9001|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 12||||0.9001
71840616|NCT03257410|143190469|OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|2.372||0.3279|TWO_SIDED||||||Mixed-effect Model Repeated Measurement|||Week 24||||0.3279
71840617|NCT03257410|143190470|OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.452||0.6576|TWO_SIDED||||||ANCOVA|||||||0.6576
71840618|NCT03257410|143190471|OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.104||0.0058|TWO_SIDED||||||ANCOVA|||||||0.0058
71840619|NCT03257410|143190472|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.023||0.034|TWO_SIDED||||||ANCOVA|||||||0.034
71840620|NCT03257410|143190473|OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.071||0.0285|TWO_SIDED||||||ANCOVA|||||||0.0285
71840621|NCT03257410|143190474|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.513||0.9069|TWO_SIDED||||||ANCOVA|||||||0.9069
71840622|NCT03257410|143190475|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.443||0.8413|TWO_SIDED||||||ANCOVA|||||||0.8413
71840623|NCT03257410|143190476|OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.382||0.0125|TWO_SIDED||||||ANCOVA|||||||0.0125
71840624|NCT03257410|143190477|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.561||0.6891|TWO_SIDED||||||ANCOVA|||||||0.6891
71840625|NCT03257410|143190478|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.047||0.6043|TWO_SIDED||||||ANCOVA|||||||0.6043
71840626|NCT03257410|143190479|OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|2.08||0.5067|TWO_SIDED||||||ANCOVA|||||||0.5067
71840627|NCT03257410|143190480|OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0297|TWO_SIDED||||||ANCOVA|||||||0.0297
71840628|NCT03257410|143190481|OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|2.14||0.1325|TWO_SIDED||||||ANCOVA|||||||0.1325
71840629|NCT03257410|143190482|OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2304|TWO_SIDED||||||ANCOVA|||||||0.2304
71797918|NCT05429203|143095791|OTHER|||||||0.5||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.5
71797919|NCT05429203|143095792|OTHER|||||||0.9||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
71797920|NCT05429203|143095793|OTHER|||||||0.8||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.8
71840630|NCT03257410|143190483|OTHER||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|2.846||0.5785|TWO_SIDED||||||ANCOVA|||||||0.5785
71674395|NCT02915705|142867360|SUPERIORITY||difference|1.26|||<|0.0001|TWO_SIDED|95.0|0.97|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||1.54|0.97|< 0.0001
71674396|NCT02915705|142867360|SUPERIORITY||difference|1.25|||<|0.0001|TWO_SIDED|95.0|0.96|1.54|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||1.54|0.96|< 0.0001
71674397|NCT02915705|142867362|SUPERIORITY||difference|-92.53|||<|0.0001|TWO_SIDED|95.0|-131.4|-53.66|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 16||-53.66|-131.40|< 0.0001
71797921|NCT05429203|143095794|OTHER|||||||0.9||||||the a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.9
71840631|NCT03257410|143190484|OTHER||Mean Difference (Final Values)|2.55|STANDARD_ERROR_OF_MEAN|0.918||0.0067|TWO_SIDED||||||ANCOVA|||||||0.0067
71840632|NCT03257410|143190485|OTHER||Mean Difference (Final Values)|-14.93|STANDARD_ERROR_OF_MEAN|7.314||0.0434|TWO_SIDED||||||ANCOVA|||||||0.0434
71840633|NCT03257410|143190486|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3281|TWO_SIDED||||||ANCOVA|||||||0.3281
71674398|NCT02915705|142867362|SUPERIORITY||difference|-85.57|||<|0.0001|TWO_SIDED|95.0|-126.37|-44.76|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 24||-44.76|-126.37|< 0.0001
71674399|NCT02915705|142867362|SUPERIORITY||difference|-95.95|||<|0.0001|TWO_SIDED|95.0|-136.05|-55.84|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 40||-55.84|-136.05|< 0.0001
71797922|NCT00433654|143095798|SUPERIORITY_OR_OTHER_LEGACY||Percentage|0.0|||<|0.001|ONE_SIDED|95.0||1.7|||exact test of binomial proportions|||Null hypothesis: rate \> 10%||1.7||<0.001
71840634|NCT03257410|143190487|OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.334||0.0463|TWO_SIDED||||||ANCOVA|||||||0.0463
71840635|NCT03257410|143190488|OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.06||0.1925|TWO_SIDED||||||ANCOVA|||||||0.1925
71674400|NCT02915705|142867362|SUPERIORITY||difference|-111.28|||<|0.0001|TWO_SIDED|95.0|-152.08|-70.49|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 52||-70.49|-152.08|< 0.0001
71674401|NCT02915705|142867362|SUPERIORITY||difference|-146.56|||<|0.0001|TWO_SIDED|95.0|-191.61|-101.52|||GEE model||Difference (Burosumab - Oral Phosphate/Active Vitamin D)|Week 64||-101.52|-191.61|< 0.0001
71674402|NCT02915705|142867365|SUPERIORITY||difference in LS means|-5.02||||0.0212|TWO_SIDED|95.0|-9.29|-0.75|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||-0.75|-9.29|0.0212
71797923|NCT00433654|143095799|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.0||||||95.0||||P-value and confidence interval could not be calculated because both groups were 100% successful.|Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||
71797924|NCT00433654|143095800|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|0.5|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
71797925|NCT00433654|143095801|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|1.9|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
71797926|NCT00433654|143095802|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 10%.|Difference in percentages|2.1|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group \<= success rate control group - 10%||||<0.001
71797927|NCT00433654|143095803|SUPERIORITY_OR_OTHER_LEGACY||Percentage|8.3|||<|0.001|ONE_SIDED|95.0||10.7|||exact test of binomial proportions|||Null hypothesis: Percentage of subjects with complication \> 20%||10.7||<0.001
71797928|NCT03748641|143095814|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0217|TWO_SIDED|95.0|0.556|0.956|||Log Rank|||||0.956|0.556|0.0217
71797929|NCT03748641|143095815|SUPERIORITY||Hazard Ratio (HR)|0.533||||0.0014|TWO_SIDED|95.0|0.361|0.789|||Log Rank|||||0.789|0.361|0.0014
71813442|NCT05375955|143129297|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
71813443|NCT05375955|143129297|OTHER||Risk Difference (RD)|5.3||||0.2751|TWO_SIDED|95.0|-10.7|22.1|||Chan and Zhang (1999) method|||Week 8||22.1|-10.7|0.2751
71813444|NCT05375955|143129297|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
71813445|NCT05375955|143129297|OTHER||Risk Difference (RD)|3.1||||0.3997|TWO_SIDED|95.0|-13.6|20.2|||Chan and Zhang (1999) method|||Week 10||20.2|-13.6|0.3997
71813446|NCT05375955|143129297|OTHER||Risk Difference (RD)|7.9||||0.2736|TWO_SIDED|95.0|-9.5|25.7|||Chan and Zhang (1999) method|||Week 12||25.7|-9.5|0.2736
71813447|NCT05375955|143129297|OTHER||Risk Difference (RD)|12.7||||0.1119|TWO_SIDED|95.0|-5.6|31.0|||Chan and Zhang (1999) method|||Week 12||31.0|-5.6|0.1119
71813448|NCT05375955|143129298|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-10.6|11.0|||Chan and Zhang (1999) method|||Week 1||11.0|-10.6|1.0000
71813449|NCT05375955|143129298|OTHER||Risk Difference (RD)|2.9||||0.2697|TWO_SIDED|95.0|-7.8|14.9|||Chan and Zhang (1999) method|||Week 1||14.9|-7.8|0.2697
71813450|NCT05375955|143129298|OTHER||Risk Difference (RD)|3.0||||0.2578|TWO_SIDED|95.0|-7.8|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-7.8|0.2578
71813451|NCT05375955|143129298|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 2||20.7|-4.9|0.0993
71813452|NCT05375955|143129298|OTHER||Risk Difference (RD)|5.7||||0.114|TWO_SIDED|95.0|-5.3|19.2|||Chan and Zhang (1999) method|||Week 2||19.2|-5.3|0.1140
71813453|NCT05375955|143129298|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 2||24.3|-2.1|0.0436
71797930|NCT05179421|143095825|OTHER|NONMEM applies nonlinear mixed effects modeling to evaluate the relationship between predicted drug concentration after administration from known pharmacokinetics and a pharmacodynamic effect, in this case being a reduction in pain from sustained heat application.|||||<|0.05|||||||Mixed Models Analysis|||Pain scores over time will first be modeled using NONMEM with derived parameters of maximum effect (Emax) and doses to produce a 50% and 90% maximum drug effect (C50 and C90, respectively), the steepness of the dose response curve (γ), and the time to peak effect. Inter-subject variability (e.g., biological variability) will evaluate additive, proportional, and exponential models. Residual intrasubject variability (e.g., noise) will typically require an additive and multiplicative error model.||||<0.05
71797931|NCT00792610|143095826|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|STANDARD_DEVIATION|0.05|<|0.05||95.0|0.05|0.15|||t-test, 2 sided|||Chi-square analysis and Fischer's exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.||.15|.05|<0.05
71797932|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.|Slope|-0.0099|STANDARD_ERROR_OF_MEAN|0.01572||0.5291|TWO_SIDED|95.0|-0.04075|0.02095||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2|||0.02095|-0.04075|0.5291
71797933|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.|Slope|0.1329|STANDARD_ERROR_OF_MEAN|0.0174|<|0.001|TWO_SIDED|95.0|0.0988|0.1671||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2|||0.1671|0.09880|<0.001
71797934|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.|Slope|0.2016|STANDARD_ERROR_OF_MEAN|0.01812|<|0.0001|TWO_SIDED|95.0|0.166|0.2371||The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.|Mixed Models Analysis||Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting|||0.2371|0.1660|<.0001
71797935|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
71797936|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)||||0.242
71797937|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
71797938|NCT04521166|143095840|OTHER|A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).|Slope|0.002||||0.242|TWO_SIDED|||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).||||0.242
71840636|NCT03257410|143190489|OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.389||0.2569|TWO_SIDED||||||ANCOVA|||||||0.2569
71840637|NCT03257410|143190490|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.104||0.5709|TWO_SIDED||||||ANCOVA|||||||0.5709
71840638|NCT03257410|143190491|OTHER||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.412||0.217|TWO_SIDED||||||ANCOVA|||||||0.217
71797939|NCT02614547|143095842|SUPERIORITY||Least Squares Mean Difference|-12.22|STANDARD_ERROR_OF_MEAN|4.081||0.008|TWO_SIDED|95.0|-20.77|-3.67|||MMRM|||Mixed Effects Model for Repeated Measure (MMRM) used an unstructured covariance model time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-3.67|-20.77|0.008
71797940|NCT02614547|143095843|SUPERIORITY||Odds Ratio (OR)|4.08||||0.198|TWO_SIDED|95.0|0.49|37.67|||Fisher Exact|||60 Hours||37.67|0.49|0.198
71797941|NCT02614547|143095843|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
71797942|NCT02614547|143095843|SUPERIORITY||Odds Ratio (OR)|6.22||||0.086|TWO_SIDED|95.0|0.7|62.08|||Fisher Exact|||Day 30||62.08|0.70|0.086
71797943|NCT02614547|143095844|SUPERIORITY||Odds Ratio (OR)|23.33||||0.008|TWO_SIDED|95.0|1.56|1152.71|||Fisher Exact|||60 Hours||1152.71|1.56|0.008
71797944|NCT02614547|143095844|SUPERIORITY|||||||0.003|||||||Fisher Exact|||Day 7||||0.003
71840639|NCT03257410|143190492|OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|1.292||0.2386|TWO_SIDED||||||ANCOVA|||||||0.2386
71840640|NCT03257410|143190493|OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.84||0.1769|TWO_SIDED||||||ANCOVA|||||||0.1769
71840641|NCT03257410|143190494|OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.36||0.8102|TWO_SIDED||||||ANCOVA|||||||0.8102
71674403|NCT02915705|142867365|SUPERIORITY||difference in LS means|2.68||||0.1009|TWO_SIDED|95.0|-0.52|5.89|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.89|-0.52|0.1009
71674404|NCT02915705|142867365|SUPERIORITY||difference in LS means|-3.25||||0.1676|TWO_SIDED|95.0|-7.86|1.37|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||1.37|-7.86|0.1676
71674405|NCT02915705|142867366|SUPERIORITY||difference in LS means|-2.26||||0.3091|TWO_SIDED|95.0|-6.61|2.09|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||2.09|-6.61|0.3091
71674406|NCT02915705|142867366|SUPERIORITY||difference in LS means|1.9||||0.3145|TWO_SIDED|95.0|-1.8|5.59|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||5.59|-1.80|0.3145
71674407|NCT02915705|142867366|SUPERIORITY||difference in LS means|-1.08||||0.681|TWO_SIDED|95.0|-6.21|4.06|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||4.06|-6.21|0.6810
71797945|NCT02614547|143095844|SUPERIORITY||Odds Ratio (OR)|10.5||||0.03|TWO_SIDED|95.0|1.01|140.57|||Fisher Exact|||Day 30||140.57|1.01|0.030
71797946|NCT02614547|143095845|SUPERIORITY||Least Squares Mean Difference|-15.86|STANDARD_ERROR_OF_MEAN|5.536||0.01|TWO_SIDED|95.0|-27.5|-4.22|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.22|-27.50|0.010
71797947|NCT02614547|143095845|SUPERIORITY||Least Square Mean Difference|-15.96|STANDARD_ERROR_OF_MEAN|5.448||0.009|TWO_SIDED|95.0|-27.43|-4.5|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.50|-27.43|0.009
71797948|NCT02614547|143095845|SUPERIORITY||Least Square Mean Difference|-15.07|STANDARD_ERROR_OF_MEAN|5.213||0.01|TWO_SIDED|95.0|-26.05|-4.09|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment||-4.09|-26.05|0.010
71797949|NCT02614547|143095846|SUPERIORITY||Odds Ratio (OR)|7.0||||0.08|TWO_SIDED|95.0|0.73|90.81|||Fisher Exact|||60 Hours||90.81|0.73|0.080
71797950|NCT02614547|143095846|SUPERIORITY||Odds Ratio (OR)|16.0||||0.023|TWO_SIDED|95.0|1.31|239.57|||Fisher Exact|||Day 7||239.57|1.31|0.023
71797951|NCT02614547|143095846|SUPERIORITY||Odds Ratio (OR)|10.67||||0.03|TWO_SIDED|95.0|1.04|142.2|||Fisher Exact|||Day 30||142.20|1.04|0.030
71797952|NCT02614547|143095847|SUPERIORITY||Least Squares Mean Difference|-6.05|STANDARD_ERROR_OF_MEAN|2.466||0.025|TWO_SIDED|95.0|-11.24|-0.86|||MMRM|||60 Hours: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-0.86|-11.24|0.025
71797953|NCT02614547|143095847|SUPERIORITY||Least Squares Mean Difference|-6.46|STANDARD_ERROR_OF_MEAN|2.427||0.016|TWO_SIDED|95.0|-11.57|-1.34|||MMRM|||Day 7: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.34|-11.57|0.016
71797954|NCT02614547|143095847|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.568||0.018|TWO_SIDED|95.0|-12.25|-1.35|||MMRM|||Day 30: MMRM used an unstructured covariance model for time points within participant. Fixed effects were treatment, baseline total score, assessment time point, and time point-by-treatment.||-1.35|-12.25|0.018
71797955|NCT02614547|143095849|SUPERIORITY||Least Squares Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|2.461||0.457|TWO_SIDED|95.0|-3.3|7.04|||ANCOVA|||60 Hours||7.04|-3.30|0.457
71797956|NCT02614547|143095849|SUPERIORITY||Least Square Mean|-1.47|STANDARD_ERROR_OF_MEAN|-1.47||0.613|TWO_SIDED|95.0|-7.5|4.55|||ANCOVA|||Day 7||4.55|-7.50|0.613
71797957|NCT02614547|143095849|SUPERIORITY||Least Square Mean|-2.1|STANDARD_ERROR_OF_MEAN|2.871||0.474|TWO_SIDED|95.0|-8.13|3.93|||ANCOVA|||Day 30||3.93|-8.13|0.474
71797958|NCT05619692|143095912|SUPERIORITY||Difference in LS Means|1.5|STANDARD_ERROR_OF_MEAN|1.11||0.1642|TWO_SIDED|95.0|-0.64|3.73||The p-value was obtained using MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MRMM||Difference was calculated as SAGE-718 - placebo.|||3.73|-0.64|0.1642
71813454|NCT05375955|143129298|OTHER||Risk Difference (RD)|6.1||||0.0993|TWO_SIDED|95.0|-4.9|20.7|||Chan and Zhang (1999) method|||Week 4||20.7|-4.9|0.0993
71813455|NCT05375955|143129298|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 4||33.9|4.9|0.0071
71813456|NCT05375955|143129298|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 4||32.0|3.2|0.0104
71813457|NCT05375955|143129298|OTHER||Risk Difference (RD)|15.2||||0.0104|TWO_SIDED|95.0|3.2|32.0|||Chan and Zhang (1999) method|||Week 6||32.0|3.2|0.0104
71813458|NCT05375955|143129298|OTHER||Risk Difference (RD)|17.1||||0.0071|TWO_SIDED|95.0|4.9|33.9|||Chan and Zhang (1999) method|||Week 6||33.9|4.9|0.0071
71813459|NCT05375955|143129298|OTHER||Risk Difference (RD)|24.2||||0.0011|TWO_SIDED|95.0|10.4|42.3|||Chan and Zhang (1999) method|||Week 6||42.3|10.4|0.0011
71813460|NCT05375955|143129298|OTHER||Risk Difference (RD)|9.1||||0.0436|TWO_SIDED|95.0|-2.1|24.3|||Chan and Zhang (1999) method|||Week 8||24.3|-2.1|0.0436
71674408|NCT02915705|142867367|SUPERIORITY||Difference in LS Means|0.01||||0.9862|TWO_SIDED|95.0|-0.79|0.8|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.80|-0.79|0.9862
71840642|NCT03257410|143190495|OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.501||0.9672|TWO_SIDED||||||ANCOVA|||||||0.9672
71840643|NCT03257410|143190496|OTHER||Mean Difference (Final Values)|27.34|STANDARD_ERROR_OF_MEAN|24.623||0.2697|TWO_SIDED||||||ANCOVA|||||||0.2697
71797959|NCT06561217|143095974|NON_INFERIORITY|A predefined non-inferiority margin of 0.05 was used. The primary study was powered on a retrospective, paired, non-inferiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02|||<|0.001|ONE_SIDED|95.0|0.00007515||||Wilcoxon (Mann-Whitney)||The upper bound of the 95% confidence interval is Inf due to the test being one-sided. Alternative hypothesis: true median location shift is greater than -0.05|A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the primary null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was non-inferior to the chart-level accuracy of a Human-alone arm abstraction by at least 5% (i.e., noninferiority margin).|||0.00007515|<0.001
71797960|NCT06561217|143095974|SUPERIORITY|The primary study was powered on a retrospective, paired, superiority design to evaluate abstraction accuracy of elements commonly used to help screen patients for clinical trials.|Mean Difference (Final Values)|0.02||||0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A Shapiro-Wilk test was used to assess normality of paired differences in chart-level accuracy (alpha = 0.05). A one-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test the null hypothesis of whether chart-level accuracy of the Human+AI arm for EHR chart abstraction was superior to the chart-level accuracy of a Human-alone arm abstraction.||||0.002
71797961|NCT06561217|143095975|EQUIVALENCE|Null hypothesis: True difference is equal to 0. Alternate hypothesis: true difference is not equal to 0|Median Difference (Final Values)|0.66||||0.513|TWO_SIDED|95.0|-1.25|2.55|||Wilcoxon (Mann-Whitney)|||A two-sided, paired Wilcoxon Rank Sum test (alpha = 0.05) was employed to test for difference between chart-level efficiency of the Human+AI arm and chart-level efficiency of the Human-alone arm abstraction.||2.55|-1.25|0.513
71797962|NCT04552587|143095986|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||We compared change from baseline to follow up in our single group of caregivers.||||0.23
71797963|NCT00613509|143096005|SUPERIORITY_OR_OTHER|||||||0.9406|TWO_SIDED|95.0|||||Log Rank|||||||0.9406
71797964|NCT00613509|143096005|SUPERIORITY_OR_OTHER|||||||0.9179|TWO_SIDED|95.0|||||Likelihood ratio test|||||||0.9179
71797965|NCT01686646|143096030|SUPERIORITY_OR_OTHER||LS Mean DIfference|3.5||||0.0248|TWO_SIDED|95.0|0.4|6.5||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||6.5|0.4|0.0248
71797966|NCT01686646|143096030|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.1513|TWO_SIDED|95.0|-0.6|4.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||4.1|-0.6|0.1513
71840644|NCT03257410|143190499|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.115||0.7189|TWO_SIDED||||||ANCOVA|||||||0.7189
71840645|NCT03257410|143190500|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.044||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
71840646|NCT03257410|143190501|OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.113||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
71840647|NCT03257410|143190502|OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0733|TWO_SIDED||||||ANCOVA|||||||0.0733
71797967|NCT01686646|143096030|SUPERIORITY_OR_OTHER||LS Mean Difference|3.9|||||TWO_SIDED|95.0|1.1|6.6||Not significant based on hierarchical testing.|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.||6.6|1.1|
71797968|NCT01686646|143096031|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0696|TWO_SIDED|95.0|-0.2|6.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.||6.1|-0.2|0.0696
71797969|NCT01686646|143096031|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|||||TWO_SIDED|95.0|0.3|5.2||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||5.2|0.3|
71840648|NCT03257410|143190503|OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|5.467||0.5326|TWO_SIDED||||||ANCOVA|||||||0.5326
71840649|NCT03257410|143190504|OTHER||Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|1.076||0.3042|TWO_SIDED||||||ANCOVA|||||||0.3042
71840650|NCT03257410|143190505|OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.976||0.5534|TWO_SIDED||||||ANCOVA|||||||0.5534
71840651|NCT03257410|143190506|OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|1.181||0.2958|TWO_SIDED||||||ANCOVA|||||||0.2958
71840652|NCT03257410|143190507|OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.377||0.0998|TWO_SIDED||||||ANCOVA|||||||0.0998
71840653|NCT03257410|143190508|OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|3.176||0.9952|TWO_SIDED||||||ANCOVA|||||||0.9952
71797970|NCT01686646|143096031|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||||TWO_SIDED|95.0|-1.7|3.9||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p\<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.||3.9|-1.7|
71797971|NCT00556842|143096044|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-6.37|||||TWO_SIDED|99.0|-9.18|-3.56||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC total at 24 months.||-3.56|-9.18|
71797972|NCT00556842|143096044|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.93|||||TWO_SIDED|99.0|-1.42|-0.44||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC pain at 24 months.||-0.44|-1.42|
71797973|NCT00556842|143096044|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-0.44|||||TWO_SIDED|99.0|-0.65|-0.23||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC stiffness at 24 months.||-0.23|-0.65|
71797974|NCT00556842|143096044|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|-4.97|||||TWO_SIDED|99.0|-7.11|-2.83||||||Using a multi-level model, the effect of THA versus HA on function (WOMAC) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for WOMAC function at 24 months.||-2.83|-7.11|
71797975|NCT00556842|143096045|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Odds Ratio (OR)|0.72|||||TWO_SIDED|99.0|0.38|1.36||||||Using a multi-level model, the effect of THA versus HA on mobility (TUG) was estimated. We analyzed the TUG as a dichotomous outcome with the following categories: a) patients who complete the test in ≤12 seconds, and b) those who require \>12 seconds to complete the test or were unable to complete the test. We selected 12 seconds as the cut-off because this was the threshold used by the Centers for Disease Control and Prevention. The TUG was summarized using odds ratios and 99% CIs.||1.36|0.38|
71797976|NCT00556842|143096046|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.41|||||TWO_SIDED|99.0|-0.33|3.14||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 PCS at 24 months.||3.14|-0.33|
71797977|NCT00556842|143096046|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|99.0|-0.38|3.05||||||Using a multi-level model, the effect of THA versus HA on quality of life (SF-12) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for SF-12 MCS at 24 months.||3.05|-0.38|
71797978|NCT00556842|143096047|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|99.0|-0.03|0.11||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D utility index at 24 months.||0.11|-0.03|
71797979|NCT00556842|143096047|EQUIVALENCE|Please refer to the protocol paper for details of the power calculation.|Mean Difference (Final Values)|0.72|||||TWO_SIDED|99.0|-2.02|3.46||||||Using a multi-level model, the effect of THA versus HA on quality of life (EQ-5D) was estimated. We chose an alpha level of 0.01. The results below are the mean difference in score for EQ-5D VAS at 24 months.||3.46|-2.02|
71797980|NCT03400033|143096049|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95 percent (%) confidence interval (CI) for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.05|||||TWO_SIDED|95.0|-0.21|0.1||||||||0.10|-0.21|
71797981|NCT03400033|143096050|SUPERIORITY||LS mean difference|-8.12||||0.3354|TWO_SIDED|95.0|-45.66|29.41|||ANCOVA|||||29.41|-45.66|0.3354
71797982|NCT03400033|143096051|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|-0.14|||||TWO_SIDED|95.0|-0.37|0.1||||||||0.10|-0.37|
71797983|NCT03400033|143096052|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was above the non-inferiority margin of - 15%.|Median Difference (Final Values)|11.18||||0.0034|TWO_SIDED|95.0|2.83|19.56|||Van Elteren's test||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||19.56|2.83|0.0034
71797984|NCT03400033|143096053|OTHER||Difference in response rate|0.1645||||0.0007|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||||0.27|0.06|0.0007
71797985|NCT03400033|143096054|OTHER||Hazard Ratio (HR)|1.06||||0.5308|TWO_SIDED|95.0|0.26|4.22|||Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||4.22|0.26|0.5308
71797986|NCT03400033|143096055|SUPERIORITY||LS mean difference|-3.73||||0.083|TWO_SIDED|95.0|-9.03|1.56|||MMRM||SBP|||1.56|-9.03|0.083
71797987|NCT03400033|143096055|SUPERIORITY||LS mean difference|-2.23||||0.057|TWO_SIDED|95.0|-4.99|0.54|||MMRM||DBP|||0.54|-4.99|0.057
71797988|NCT03400033|143096055|SUPERIORITY||LS mean difference|-2.6||||0.059|TWO_SIDED|95.0|-5.86|0.67|||MMRM||MAP|||0.67|-5.86|0.059
71797989|NCT03400033|143096056|SUPERIORITY||Mean Difference (Net)|-0.5||||0.407|TWO_SIDED|95.0|-4.73|3.72|||ANCOVA||SBP|||3.72|-4.73|0.407
71797990|NCT03400033|143096056|SUPERIORITY||Mean Difference (Net)|-1.05||||0.179|TWO_SIDED|95.0|-3.29|1.19|||ANCOVA||DBP|||1.19|-3.29|0.179
71797991|NCT03400033|143096056|SUPERIORITY||Mean Difference (Net)|-0.86||||0.261|TWO_SIDED|95.0|-3.5|1.78|||ANCOVA||MAP|||1.78|-3.50|0.261
71797992|NCT03400033|143096057|OTHER||Ratio of exacerbation rate|0.7||||0.0093|TWO_SIDED|95.0|0.52|0.94|||Negative binomial model|||||0.94|0.52|0.0093
71797993|NCT03400033|143096059|SUPERIORITY||LS mean difference|-0.15||||0.0323|TWO_SIDED|95.0|-0.32|0.01|||MMRM||Week 8|||0.01|-0.32|0.0323
71840654|NCT03257410|143190509|OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.693||0.3063|TWO_SIDED||||||ANCOVA|||||||0.3063
71840655|NCT03257410|143190510|OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.529||0.1098|TWO_SIDED||||||ANCOVA|||||||0.1098
71840656|NCT03257410|143190511|OTHER||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.797||0.0766|TWO_SIDED||||||ANCOVA|||||||0.0766
71840657|NCT03257410|143190512|OTHER||Mean Difference (Final Values)|-2.58|STANDARD_ERROR_OF_MEAN|2.41||0.2886|TWO_SIDED||||||ANCOVA|||||||0.2886
71840658|NCT03257410|143190513|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.042||0.4513|TWO_SIDED||||||ANCOVA|||||||0.4513
71840659|NCT03257410|143190514|OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|2.96||0.5992|TWO_SIDED||||||ANCOVA|||||||0.5992
71840660|NCT03257410|143190515|OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.29||0.3836|TWO_SIDED||||||ANCOVA|||||||0.3836
71840661|NCT03257410|143190516|OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|7.284||0.0769|TWO_SIDED||||||ANCOVA|||||||0.0769
71840662|NCT03257410|143190517|OTHER||Mean Difference (Final Values)|-19.56|STANDARD_ERROR_OF_MEAN|5.17||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
71840663|NCT03257410|143190518|OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|1.039||0.1825|TWO_SIDED||||||ANCOVA|||||||0.1825
71840664|NCT03257410|143190519|OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.737||0.0957|TWO_SIDED||||||ANCOVA|||||||0.0957
71840665|NCT03257410|143190520|OTHER||Mean Difference (Final Values)|-34.02|STANDARD_ERROR_OF_MEAN|10.23||0.0012|TWO_SIDED||||||ANCOVA|||||||0.0012
71840666|NCT03257410|143190521|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.859||0.1824|TWO_SIDED||||||ANCOVA|||||||0.1824
71840667|NCT02561247|143190522|OTHER|||||||0.0008||||||P Value is from a one sample t-test compared against the null hypothesis value|t-test, 1 sided|Null Hypothesis Value = -38; Degrees of Freedom=16; t-value=-4.13||P Value is from a one sample t-test compared against the null hypothesis value. No adjustments were made for multiple comparisons/multiplicity in this study, since there was only one primary endpoint, one arm, and one pre-specified primary null hypothesis.||||0.0008
71840668|NCT03656510|143190560|OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-1.382|0.185||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.185|-1.382|
71840669|NCT03656510|143190560|OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-1.19|0.418||||||Difference versus placebo in mean RSV viral load AUC on Day 3||0.418|-1.190|
71840670|NCT03656510|143190560|OTHER||Mean Difference (Final Values)|-2.46|||||TWO_SIDED|95.0|-4.674|-0.25||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.250|-4.674|
71840671|NCT03656510|143190560|OTHER||Mean Difference (Final Values)|-2.38|||||TWO_SIDED|95.0|-4.645|-0.114||||||Difference versus placebo in mean RSV viral load AUC on Day 8||-0.114|-4.645|
71840672|NCT05671653|143190606|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|88.85|||||TWO_SIDED|90.0|80.25|98.38||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||98.38|80.25|
71840673|NCT05671653|143190606|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|70.0|||||TWO_SIDED|90.0|55.21|88.76||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||88.76|55.21|
71840674|NCT05671653|143190607|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|57.19|||||TWO_SIDED|90.0|39.27|83.29||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).||83.29|39.27|
71840675|NCT05671653|143190607|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|29.68|||||TWO_SIDED|90.0|19.6|44.94||||||Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).||44.94|19.60|
71840676|NCT05671653|143190608|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|119.86|||||TWO_SIDED|90.0|108.97|131.85||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||131.85|108.97|
71840677|NCT05671653|143190608|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|185.45|||||TWO_SIDED|90.0|108.0|318.44||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||318.44|108.00|
71840678|NCT05671653|143190609|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|103.17|||||TWO_SIDED|90.0|95.09|111.93||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 5).||111.93|95.09|
71896272|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|1.223||||0.746|TWO_SIDED|95.0|0.361|4.151||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.151|0.361|0.746
71797994|NCT03400033|143096059|SUPERIORITY||LS mean difference|-0.12||||0.0921|TWO_SIDED|95.0|-0.29|0.06|||MMRM||Week 12|||0.06|-0.29|0.0921
71797995|NCT03400033|143096059|SUPERIORITY||LS mean difference|-0.11||||0.1291|TWO_SIDED|95.0|-0.29|0.08|||MMRM||Week 28|||0.08|-0.29|0.1291
71674409|NCT02915705|142867368|SUPERIORITY||difference in LS means|0.05||||0.8786|TWO_SIDED|95.0|-0.58|0.68|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.||0.68|-0.58|0.8786
71797996|NCT03400033|143096059|SUPERIORITY||LS mean difference|-0.15||||0.0859|TWO_SIDED|95.0|-0.36|0.06|||MMRM||Week 52|||0.06|-0.36|0.0859
71797997|NCT02741115|143096072|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.377||0.092|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|ANCOVA fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation used.||It was estimated that a sample size of 198 participants per group would provide 90% power to detect a mean treatment group difference in change from baseline to Week 26 in maximal VO2 scores of 10% (ie, an improvement of 2.8 mL/kg/min in the udenafil group compared to 0 in the control group, assuming a Type I error of 0.05 and standard deviation of 7.235). A difference of 2.8, equivalent to a 10% increase from a baseline of 28 mL/kg/min, represents approximately 0.4 standard deviations.||||0.092
71797998|NCT02741115|143096073|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.014||0.024|TWO_SIDED|||||LS mean was the estimated treatment difference from the analytical model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2.||||||0.024
71797999|NCT02741115|143096074|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.591||0.591|TWO_SIDED||||||ANCOVA|||||||0.591
71798000|NCT02741115|143096075|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.094||0.169|TWO_SIDED||||||ANCOVA|||||||0.169
71813461|NCT05375955|143129298|OTHER||Risk Difference (RD)|28.6||||0.0003|TWO_SIDED|95.0|14.2|46.3|||Chan and Zhang (1999) method|||Week 8||46.3|14.2|0.0003
71813462|NCT05375955|143129298|OTHER||Risk Difference (RD)|27.3||||0.0007|TWO_SIDED|95.0|12.9|45.8|||Chan and Zhang (1999) method|||Week 8||45.8|12.9|0.0007
71813463|NCT05375955|143129298|OTHER||Risk Difference (RD)|6.3||||0.2712|TWO_SIDED|95.0|-10.8|24.3|||Chan and Zhang (1999) method|||Week 10||24.3|-10.8|0.2712
71813464|NCT05375955|143129298|OTHER||Risk Difference (RD)|25.5||||0.0056|TWO_SIDED|95.0|5.4|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|5.4|0.0056
71813465|NCT05375955|143129298|OTHER||Risk Difference (RD)|30.6||||0.0017|TWO_SIDED|95.0|9.7|50.5|||Chan and Zhang (1999) method|||Week 10||50.5|9.7|0.0017
71813466|NCT05375955|143129298|OTHER||Risk Difference (RD)|3.4||||0.3929|TWO_SIDED|95.0|-14.9|21.6|||Chan and Zhang (1999) method|||Week 12||21.6|-14.9|0.3929
71813467|NCT05375955|143129298|OTHER||Risk Difference (RD)|28.2||||0.004|TWO_SIDED|95.0|7.0|47.7|||Chan and Zhang (1999) method|||Week 12||47.7|7.0|0.0040
71813468|NCT05375955|143129298|OTHER||Risk Difference (RD)|33.7||||0.0012|TWO_SIDED|95.0|10.4|53.7|||Chan and Zhang (1999) method|||Week 12||53.7|10.4|0.0012
71813469|NCT05375955|143129301|OTHER||Risk Difference (RD)|2.8||||0.3255|TWO_SIDED|95.0|-8.5|15.8|||Chan and Zhang (1999) method|||Week 1||15.8|-8.5|0.3255
71813470|NCT05375955|143129301|OTHER||Risk Difference (RD)|-2.5||||0.7181|TWO_SIDED|95.0|-13.3|8.3|||Chan and Zhang (1999) method|||Week 1||8.3|-13.3|0.7181
71813471|NCT05375955|143129301|OTHER||Risk Difference (RD)|18.4||||0.0022|TWO_SIDED|95.0|7.0|34.3|||Chan and Zhang (1999) method|||Week 2||34.3|7.0|0.0022
71813472|NCT05375955|143129301|OTHER||Risk Difference (RD)|14.7||||0.0064|TWO_SIDED|95.0|3.7|31.1|||Chan and Zhang (1999) method|||Week 2||31.1|3.7|0.0064
71813473|NCT05375955|143129301|OTHER||Risk Difference (RD)|13.7||||0.0659|TWO_SIDED|95.0|-3.4|31.5|||Chan and Zhang (1999) method|||Week 4||31.5|-3.4|0.0659
71813474|NCT05375955|143129301|OTHER||Risk Difference (RD)|19.4||||0.0189|TWO_SIDED|95.0|0.9|38.5|||Chan and Zhang (1999) method|||Week 4||38.5|0.9|0.0189
71813475|NCT05375955|143129301|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 6||22.3|-14.9|0.3962
71813476|NCT05375955|143129301|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 6||29.1|-10.4|0.2333
71813477|NCT05375955|143129301|OTHER||Risk Difference (RD)|3.6||||0.3962|TWO_SIDED|95.0|-14.9|22.3|||Chan and Zhang (1999) method|||Week 8||22.3|-14.9|0.3962
71813478|NCT05375955|143129301|OTHER||Risk Difference (RD)|11.9||||0.1353|TWO_SIDED|95.0|-7.9|32.7|||Chan and Zhang (1999) method|||Week 8||32.7|-7.9|0.1353
71813479|NCT05375955|143129301|OTHER||Risk Difference (RD)|6.2||||0.2791|TWO_SIDED|95.0|-12.8|25.7|||Chan and Zhang (1999) method|||Week 10||25.7|-12.8|0.2791
71813480|NCT05375955|143129301|OTHER||Risk Difference (RD)|9.0||||0.2333|TWO_SIDED|95.0|-10.4|29.1|||Chan and Zhang (1999) method|||Week 10||29.1|-10.4|0.2333
71813481|NCT05375955|143129301|OTHER||Risk Difference (RD)|11.3||||0.1295|TWO_SIDED|95.0|-7.3|30.6|||Chan and Zhang (1999) method|||Week 12||30.6|-7.3|0.1295
71813482|NCT05375955|143129301|OTHER||Risk Difference (RD)|20.3||||0.0247|TWO_SIDED|95.0|0.1|40.2|||Chan and Zhang (1999) method|||Week 12||40.2|0.1|0.0247
71813483|NCT05375955|143129302|OTHER||Risk Difference (RD)|-4.3||||0.7278|TWO_SIDED|95.0|-21.9|11.5|||Chan and Zhang (1999) method|||Week 1||11.5|-21.9|0.7278
71813484|NCT05375955|143129302|OTHER||Risk Difference (RD)|8.2||||0.2548|TWO_SIDED|95.0|-11.5|28.2|||Chan and Zhang (1999) method|||Week 1||28.2|-11.5|0.2548
71813485|NCT05375955|143129302|OTHER||Risk Difference (RD)|0.9||||0.5162|TWO_SIDED|95.0|-17.5|21.9|||Chan and Zhang (1999) method|||Week 1||21.9|-17.5|0.5162
71813486|NCT05375955|143129302|OTHER||Risk Difference (RD)|9.3||||0.1663|TWO_SIDED|95.0|-11.4|30.7|||Chan and Zhang (1999) method|||Week 2||30.7|-11.4|0.1663
71798001|NCT02741115|143096076|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Median Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|0.308||0.012|TWO_SIDED|||||LS mean was the estimated treatment mean difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.012
71798002|NCT02741115|143096077|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|||||LS mean was the estimated treatment difference in the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.029
71798003|NCT02741115|143096078|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.321||0.011|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.011
71798004|NCT02741115|143096079|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.903||0.696|TWO_SIDED||||||ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline VO2. LOCF imputation.||||||0.696
71798005|NCT02741115|143096080|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.319||0.915|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||||||0.915
71798006|NCT02741115|143096081|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.363||0.891|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline maximal VO2. LOCF imputation.||LS mean differences between treatment groups were analyzed.||||0.891
71798007|NCT02741115|143096082|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.1||0.691|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group, with a continuous covariate of Baseline physical functioning (child reported)||||||0.691
71798008|NCT02741115|143096083|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.544||0.985|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline physical functioning (parent reported).||||||0.985
71798009|NCT02741115|143096084|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.039||0.273|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (child reported).||||||0.273
71674410|NCT02915705|142867369|SUPERIORITY||difference in LS means|43.46||||0.0514|TWO_SIDED|95.0|-0.26|87.17|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||87.17|-0.26|0.0514
71798010|NCT02741115|143096085|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|1.327||0.966|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline psychosocial health summary score (parent reported).||||||0.966
71798011|NCT02741115|143096086|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|1.011||0.706|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (Treatment II).||||||0.706
71798012|NCT02741115|143096087|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.707||0.382|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (perceived physical appearance)||||||0.382
71798013|NCT02741115|143096088|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|1.611||0.236|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (treatment anxiety).||||||0.236
71798014|NCT02741115|143096089|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.99|STANDARD_ERROR_OF_MEAN|1.622||0.543|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (cognitive problems).||||||0.543
71798015|NCT02741115|143096090|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.78||0.352|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline cardiac module scale (communication problems).||||||0.352
71813487|NCT05375955|143129302|OTHER||Risk Difference (RD)|16.5||||0.0605|TWO_SIDED|95.0|-4.2|38.3|||Chan and Zhang (1999) method|||Week 2||38.3|-4.2|0.0605
71813488|NCT05375955|143129302|OTHER||Risk Difference (RD)|16.7||||0.0592|TWO_SIDED|95.0|-5.4|41.6|||Chan and Zhang (1999) method|||Week 2||41.6|-5.4|0.0592
71813489|NCT05375955|143129302|OTHER||Risk Difference (RD)|14.0||||0.1246|TWO_SIDED|95.0|-8.6|37.4|||Chan and Zhang (1999) method|||Week 4||37.4|-8.6|0.1246
71813490|NCT05375955|143129302|OTHER||Risk Difference (RD)|16.3||||0.0789|TWO_SIDED|95.0|-7.3|39.7|||Chan and Zhang (1999) method|||Week 4||39.7|-7.3|0.0789
71813491|NCT05375955|143129302|OTHER||Risk Difference (RD)|17.6||||0.0889|TWO_SIDED|95.0|-6.4|43.7|||Chan and Zhang (1999) method|||Week 4||43.7|-6.4|0.0889
71798016|NCT02741115|143096091|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|5.684||0.533|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, child reported).||||||0.533
71798017|NCT02741115|143096092|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|4.057||0.654|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (age 8-12, parent reported).||||||0.654
71798018|NCT02741115|143096093|SUPERIORITY|LS mean differences between treatment groups were analyzed.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.069||0.963|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors: ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, child reported)||||||0.963
71798019|NCT02741115|143096094|SUPERIORITY|LS mean differences between treatment group were analyzed.|Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|1.171||0.246|TWO_SIDED|||||LS mean was the estimated treatment difference from the analysis model.|ANCOVA|Fixed factors of ventricular morphology and treatment group with a continuous covariate of Baseline total score (ages 13-18, parent reported).||||||0.246
71798020|NCT01101841|143096131|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
71798021|NCT01101841|143096131|SUPERIORITY_OR_OTHER|||||||0.0001||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0001
71798022|NCT01101841|143096132|SUPERIORITY_OR_OTHER|||||||0.0066||||||Week 24 persistence of effect|Logit model|||||||0.0066
71798023|NCT01101841|143096147|SUPERIORITY_OR_OTHER|||||||0.0368||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0368
71798024|NCT01101841|143096147|SUPERIORITY_OR_OTHER|||||||0.0064||||||Week 12 severity|Rank transformed ANCOVA|||||||0.0064
71798025|NCT01167712|143096148|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.74|1.06||||||Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.||1.06|.74|
71798026|NCT01167712|143096149|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.72|1.23||||||||1.23|.72|
71798027|NCT03633396|143096167|OTHER||Least Squares (LS) Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.98||0.944|TWO_SIDED|95.0|-4.05|3.77|||Mixed-model Repeated Measures (MMRM)|MMRM including fixed effects of treatment, history of plaque psoriasis, visit, treatment by visit interaction, and Baseline PPPASI score as covariate.|Least-squares mean difference = Imsidolimab - Placebo|The change from Baseline in PPPASI at Week 16 was analyzed using a a general linear mixed model for repeated measures (MMRM). The model included fixed effects for treatment, history of plaque psoriasis (Yes/No), visit, treatment by visit interaction, and Baseline PPPASI score as covariate.||3.77|-4.05|0.944
71798028|NCT03633396|143096169|OTHER||Odds Ratio (OR)|0.879|||||TWO_SIDED|95.0|0.288|2.686|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPASI score as covariates and using multiple imputation for missing data.|||2.686|0.288|
71798029|NCT03633396|143096170|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|0.5|13.9|||||Odds ratio from a logistic regression model including treatment as fixed effect, history of plaque psoriasis and Baseline PPPIGA score as covariates and using multiple imputation for missing data.|||13.9|0.5|
71798030|NCT05478174|143096193|NON_INFERIORITY|Non inferiority margin is -8%|Risk Difference (RD)|-0.0078|||<|0.001|TWO_SIDED|95.0|-0.0411|0.0255||P-Value for non inferiority test|Farrington-Manning method|||||0.0255|-0.0411|<0.001
71798031|NCT05478174|143096194|SUPERIORITY||Risk Difference (RD)|-0.0716||||0.171|TWO_SIDED|95.0|-0.1742|0.031|||Cochran-Mantel-Haenszel|||||0.0310|-0.1742|0.171
71798032|NCT05478174|143096195|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.231|<|0.001|TWO_SIDED|95.0|-2.22|-1.31|||ANOVA|||||-1.31|-2.22|<0.001
71798033|NCT02489318|143096227|SUPERIORITY||Hazard Ratio (HR)|0.484|||<|0.0001|TWO_SIDED|95.0|0.391|0.6|||Log Rank|||||0.600|0.391|<0.0001
71798034|NCT02489318|143096228|SUPERIORITY||Hazard Ratio (HR)|0.651|||<|0.0001|TWO_SIDED|95.0|0.534|0.793|||Log Rank|||||0.793|0.534|<0.0001
71798035|NCT02489318|143096229|SUPERIORITY||Hazard Ratio (HR)|0.469|||<|0.0001|TWO_SIDED|95.0|0.35|0.63|||Log Rank|||||0.630|0.350|<.0001
71798036|NCT02489318|143096230|SUPERIORITY||Hazard Ratio (HR)|0.868||||0.1966|TWO_SIDED|95.0|0.7|1.076|||Log Rank|||||1.076|0.700|0.1966
71798037|NCT02489318|143096231|SUPERIORITY||Hazard Ratio (HR)|0.794||||0.1563|TWO_SIDED|95.0|0.576|1.094|||Log Rank|||||1.094|0.576|0.1563
71798038|NCT02489318|143096232|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.3608|TWO_SIDED|95.0|0.615|1.194|||Log Rank|||||1.194|0.615|0.3608
71798039|NCT00326612|143096239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0||||||||||||
71798040|NCT00326612|143096240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.2|3.9||||||||3.9|0.2|
71798041|NCT00326612|143096241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.4|2.7||||||||2.7|0.4|
71798042|NCT00326612|143096242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.2|8.2||||||||8.2|0.2|
71798043|NCT00326612|143096243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.0|67.3||||||||67.3|0.0|
71798044|NCT00326612|143096244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|0.2|140.7||||||||140.7|0.2|
71813492|NCT05375955|143129302|OTHER||Risk Difference (RD)|27.5||||0.0097|TWO_SIDED|95.0|4.2|50.7|||Chan and Zhang (1999) method|||Week 6||50.7|4.2|0.0097
71813493|NCT05375955|143129302|OTHER||Risk Difference (RD)|20.7||||0.0294|TWO_SIDED|95.0|-0.8|43.6|||Chan and Zhang (1999) method|||Week 6||43.6|-0.8|0.0294
71813494|NCT05375955|143129302|OTHER||Risk Difference (RD)|37.8||||0.0018|TWO_SIDED|95.0|10.9|62.2|||Chan and Zhang (1999) method|||Week 6||62.2|10.9|0.0018
71813495|NCT05375955|143129302|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 8||48.9|-3.8|0.0495
71813496|NCT05375955|143129302|OTHER||Risk Difference (RD)|7.6||||0.289|TWO_SIDED|95.0|-17.3|32.4|||Chan and Zhang (1999) method|||Week 8||32.4|-17.3|0.2890
71813497|NCT05375955|143129302|OTHER||Risk Difference (RD)|35.2||||0.0103|TWO_SIDED|95.0|5.1|62.0|||Chan and Zhang (1999) method|||Week 8||62.0|5.1|0.0103
71813498|NCT05375955|143129302|OTHER||Risk Difference (RD)|19.0||||0.1088|TWO_SIDED|95.0|-7.8|44.8|||Chan and Zhang (1999) method|||Week 10||44.8|-7.8|0.1088
71813499|NCT05375955|143129302|OTHER||Risk Difference (RD)|11.8||||0.2719|TWO_SIDED|95.0|-14.0|36.2|||Chan and Zhang (1999) method|||Week 10||36.2|-14.0|0.2719
71674411|NCT02915705|142867370|SUPERIORITY||difference in LS means|45.55||||0.0399|TWO_SIDED|95.0|2.09|89.02|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||89.02|2.09|0.0399
71798045|NCT00548808|143096247|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.4% for HbA1c was used.|Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.11||0.716|TWO_SIDED|95.0|-0.25|0.17|||ANCOVA|ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.17|-0.25|0.716
71798046|NCT00548808|143096248|SUPERIORITY_OR_OTHER|||||||0.279||95.0||||P-value for 16 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.279
71798047|NCT00548808|143096248|SUPERIORITY_OR_OTHER|||||||0.846||95.0||||P-value for 32 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.846
71798048|NCT00548808|143096248|SUPERIORITY_OR_OTHER|||||||0.741||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment\*Visit (Type 3 sums of squares).||||||0.741
71798049|NCT00548808|143096249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.465|TWO_SIDED|95.0|0.41|1.5||P-value for patients achieving HbA1c \<6.5% at 16 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.50|0.41|0.465
71813500|NCT05375955|143129302|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 10||56.6|0.4|0.0227
71813501|NCT05375955|143129302|OTHER||Risk Difference (RD)|23.5||||0.0495|TWO_SIDED|95.0|-3.8|48.9|||Chan and Zhang (1999) method|||Week 12||48.9|-3.8|0.0495
71813502|NCT05375955|143129302|OTHER||Risk Difference (RD)|15.9||||0.1246|TWO_SIDED|95.0|-10.6|40.6|||Chan and Zhang (1999) method|||Week 12||40.6|-10.6|0.1246
71813503|NCT05375955|143129302|OTHER||Risk Difference (RD)|30.0||||0.0227|TWO_SIDED|95.0|0.4|56.6|||Chan and Zhang (1999) method|||Week 12||56.6|0.4|0.0227
71813504|NCT01313286|143129340|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.08|||||TWO_SIDED|90.0|1.0|1.16|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.16|1.00|
71813505|NCT01313286|143129341|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Square means|1.18|||||TWO_SIDED|90.0|1.07|1.31|||Mixed Models Analysis|Ratio of test formulation (HCl salt) to reference formulation (free base).||||1.31|1.07|
71813506|NCT03750006|143129347|SUPERIORITY|||||||0.0238||||||Not adjusted for multiple comparisons, P \< 0.05 is considered significant.|t-test, 2 sided|paired T-test||||||0.0238
71813507|NCT03750006|143129348|SUPERIORITY|||||||0.3029|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3029
71813508|NCT03750006|143129349|SUPERIORITY|||||||0.1713|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1713
71813509|NCT03750006|143129350|SUPERIORITY|||||||0.1261|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1261
71813510|NCT03750006|143129351|SUPERIORITY|||||||0.1367|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.1367
71813511|NCT03750006|143129352|SUPERIORITY|||||||0.0111|||||||t-test, 2 sided|paired, P \< 0.05 is considered significant.||||||0.0111
71813512|NCT03750006|143129353|SUPERIORITY|||||||0.0219|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0219
71813513|NCT03750006|143129354|SUPERIORITY|||||||0.366|||||||t-test, 2 sided|Paired, P \< 0.05 considered significant.||||||0.3660
71813514|NCT03750006|143129357|SUPERIORITY|||||||0.1563|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.1563
71813515|NCT03750006|143129358|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.0110
71813516|NCT03750006|143129359|OTHER|||||||0.3282|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.3282
71813517|NCT03750006|143129360|SUPERIORITY|||||||0.5244|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5244
71813518|NCT03750006|143129361|SUPERIORITY|||||||0.5718|||||||t-test, 2 sided|Paired, P \< 0.05 is considered significant.||||||0.5718
71813519|NCT05690776|143129408|SUPERIORITY||Mean Difference (Final Values)|12.1|STANDARD_DEVIATION|10.0|<|0.0001|TWO_SIDED|95.0|9.2|15.0|||paired t-test|||||15.0|9.2|<0.0001
71813520|NCT05690776|143129409|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.133|<|0.0001|TWO_SIDED|95.0|0.053|0.128|||paired t-test|||||0.128|0.053|<0.0001
71813521|NCT05690776|143129411|SUPERIORITY||Mean Difference (Final Values)|20.7|STANDARD_DEVIATION|13.2|<|0.0001|TWO_SIDED|95.0|16.9|24.5|||paired t-test|||||24.5|16.9|<0.0001
71813522|NCT01061333|143129415|SUPERIORITY_OR_OTHER||Difference in LS mean|16.22|||<|0.0001|TWO_SIDED|90.0|10.74|21.69||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.69|10.74|<0.0001
71813523|NCT01061333|143129415|SUPERIORITY_OR_OTHER||Difference in LS Mean|15.51||||0.0001|TWO_SIDED|90.0|10.0|21.02||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||21.02|10.00|0.0001
71813524|NCT01061333|143129415|SUPERIORITY_OR_OTHER||Difference in LS Mean|8.49||||0.0432|TWO_SIDED|90.0|1.78|15.2||p-value not adjusted for simultaneous multiple comparisons|ANCOVA|||||15.20|1.78|0.0432
71813525|NCT01061333|143129416|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.27||||0.043|TWO_SIDED|90.0|1.05|1.54||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.54|1.05|0.0430
71813526|NCT01061333|143129416|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.41||||0.01|TWO_SIDED|90.0|1.15|1.72||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.72|1.15|0.0100
71813527|NCT01061333|143129416|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|1.3||||0.086|TWO_SIDED|90.0|1.01|1.67||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.67|1.01|0.0860
71798050|NCT00548808|143096249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.365|TWO_SIDED|95.0|0.51|1.28||P-value for Patients Achieving HbA1c \<7% at 16 Weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.28|0.51|0.365
71798051|NCT00548808|143096249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.683|TWO_SIDED|95.0|0.65|1.95||P-value for patients achieving HbA1c \<6.5% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.95|0.65|0.683
71798052|NCT00548808|143096249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.81|TWO_SIDED|95.0|0.68|1.64||P-value for patients achieving HbA1c \<7% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.68|0.810
71798053|NCT00548808|143096249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.555|TWO_SIDED|95.0|0.69|2.01||P-value for patients achieving HbA1c \<6.5% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||2.01|0.69|0.555
71798054|NCT00548808|143096249|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.829|TWO_SIDED|95.0|0.67|1.64||P-value for patients achieving HbA1c \<7% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit\*treatment.||||1.64|0.67|0.829
71798055|NCT00548808|143096251|SUPERIORITY_OR_OTHER|||||||0.604||95.0||||P-value for Week 16 Change from Baseline|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.604
71798056|NCT00548808|143096251|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-value for Week 32 Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.814
71798057|NCT00548808|143096251|SUPERIORITY_OR_OTHER|||||||0.582||95.0||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment\*Visit||||||0.582
71798058|NCT00548808|143096254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.08||0.162|TWO_SIDED|95.0|-0.26|0.04||P-value for Cholesterol.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.04|-0.26|0.162
71840679|NCT05671653|143190609|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|90.2|||||TWO_SIDED|90.0|60.24|135.06||||||Reference: Cohort 1: LE 0.15 mg \& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \& EE 0.03 mg (Period 8)||135.06|60.24|
71840680|NCT05671653|143190610|OTHER|Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.|Ratio (%) of Adjusted Geometric Means|92.88|||||TWO_SIDED|90.0|79.97|107.87||||||Reference: Cohort 2: Midazolam 2 mg (Period 1). Test: Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3).||107.87|79.97|
71798059|NCT00548808|143096254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.09||0.165|TWO_SIDED|95.0|-0.3|0.05||P-value for Triglycerides.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.05|-0.30|0.165
71798060|NCT00548808|143096254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.51|TWO_SIDED|95.0|-0.18|0.09||P-value for Low Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.09|-0.18|0.510
71840681|NCT03952338|143190686|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.97|TWO_SIDED|95.0|-4.07|3.93|||Mixed Models Analysis|||||3.93|-4.07|0.97
71840682|NCT03952338|143190687|SUPERIORITY||Mean Difference (Final Values)|1.22||||0.57|TWO_SIDED|95.0|-3.0|5.44|||Mixed Models Analysis|||||5.44|-3.00|0.57
71840683|NCT03952338|143190688|SUPERIORITY||Mean Difference (Final Values)|1.96||||0.09|TWO_SIDED|95.0|-0.32|4.23|||Mixed Models Analysis|||||4.23|-0.32|0.09
71798061|NCT00548808|143096254|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.382|TWO_SIDED|95.0|-0.02|0.06||P-value for High Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.|||0.06|-0.02|0.382
71798062|NCT00749775|143096258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
71798063|NCT00749775|143096258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
71798064|NCT00749775|143096258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
71798065|NCT00749775|143096258|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
71798066|NCT00749775|143096259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.||||<0.001
71798067|NCT00749775|143096259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.||||<0.001
71798068|NCT00749775|143096259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.||||<0.001
71798069|NCT00749775|143096259|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|ONE_SIDED||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.||||<0.001
71798070|NCT04537806|143096263|SUPERIORITY||Proc Genmod|0.0||||1|TWO_SIDED|95.0|-31.8|31.8|||Chi-squared||Estimates for treatment, and the corresponding 95% confidence interval (CI) were estimated using Proc Genmod method, with treatment as a factor and age groups as a covariate variable.|||31.8|-31.8|1.0000
71798071|NCT05459129|143096266|SUPERIORITY||Difference in pCR Rates|33.33|||||TWO_SIDED|95.0|-33.23|99.9||||||||99.90|-33.23|
71798072|NCT05459129|143096267|SUPERIORITY||Difference in pRR|33.33|||||TWO_SIDED|95.0|-21.05|87.72||||||||87.72|-21.05|
71798073|NCT05459129|143096268|SUPERIORITY||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.11|3.91|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of median EFS per arm or HR between the arms.|||3.91|0.11|
71798074|NCT05459129|143096269|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.13|6.43|||||HR was estimated by Cox regression. Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made in terms of media RFS per arm or HR between the arms.|||6.43|0.13|
71798075|NCT05459129|143096271|SUPERIORITY||Difference in ORR|16.67|||||TWO_SIDED|95.0|-54.99|88.32||||||||88.32|-54.99|
71798076|NCT05459129|143096272|SUPERIORITY||Difference in Event Free Rate|16.67|||||TWO_SIDED|95.0|-31.42|64.75|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|3 Months Analysis||64.75|-31.42|
71674412|NCT02915705|142867371|SUPERIORITY||difference in LS means|6.72||||0.0633|TWO_SIDED|95.0|-0.37|13.82|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||13.82|-0.37|0.0633
71674413|NCT02915705|142867372|SUPERIORITY||difference in LS means|7.27||||0.0496|TWO_SIDED|95.0|0.01|14.52|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.||14.52|0.01|0.0496
71798077|NCT05459129|143096272|SUPERIORITY||Difference in Event Free Rate|0.0|||||TWO_SIDED|95.0|-53.34|53.34|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made.|6 Months Analysis||53.34|-53.34|
71798078|NCT05459129|143096273|SUPERIORITY||Difference in Event Free Rate|-13.33|||||TWO_SIDED|95.0|-64.83|38.16|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|3 Months Analysis||38.16|-64.83|
71798079|NCT05459129|143096273|SUPERIORITY||Difference in Event Free Rate|6.67|||||TWO_SIDED|95.0|-50.49|63.82|||||Due to the early termination of the study, the limited sample size and follow-up time no meaningful conclusions can be made|6 Months Analysis||63.82|-50.49|
71798080|NCT04530552|143096308|OTHER||See above|0.895|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 50%||||
71798081|NCT04530552|143096308|OTHER||See above|0.943|||||TWO_SIDED|||||||||Posterior probability of observing a response rate ≥ 25%||||
71798082|NCT04530552|143096309|OTHER|Two-sided paired t-test at 2.5% significance level (Bonferroni correction)||||||0.034||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.034
71798083|NCT04530552|143096309|OTHER|||||||0.252||||||Two-sided paired t-test at 2.5% significance level (Bonferroni correction)|paired t-test|||||||0.252
71798084|NCT04530552|143096310|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
71798085|NCT04530552|143096310|OTHER|||||||1||||||Significance level of 2.5% (Bonferroni correction)|Pearson correlation|||Correlation with % change PSA at end-of-intervention||||1.0
71798086|NCT04530552|143096311|OTHER|||||||0.658||||||two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.658
71798087|NCT04530552|143096311|OTHER|||||||0.167||||||Two-sided paired t-test (no Bonferroni adjustment)|paired t-test|||||||0.167
71798088|NCT06034496|143096315|SUPERIORITY|||||||0.012||||||CES main effect|ANOVA|||||||.012
71798089|NCT06034496|143096315|SUPERIORITY|||||||0.33||||||Session main effect|ANOVA|||||||.33
71798090|NCT06034496|143096315|SUPERIORITY|||||||0.85||||||Session (baseline, follow-up) x CES|ANOVA|||||||.85
71798091|NCT06034496|143096316|SUPERIORITY|||||||0.6||||||CES main effect|ANOVA|||||||.6
71798092|NCT06034496|143096316|SUPERIORITY|||||||0.9||||||Session main effect|ANOVA|||||||.9
71798093|NCT06034496|143096316|SUPERIORITY|||||||0.05||||||CES x Session interaction|ANOVA|||||||.05
71798094|NCT06034496|143096317|SUPERIORITY|||||||0.26||||||CES main effect|ANOVA|||||||.26
71798095|NCT06034496|143096317|SUPERIORITY|||||||0.17||||||Session main effect|ANOVA|||||||.17
71798096|NCT06034496|143096317|SUPERIORITY|||||||0.73||||||CES x Session main effect|ANOVA|||||||.73
71798097|NCT06034496|143096318|SUPERIORITY|||||||0.18||||||CES main effect|ANOVA|||||||.18
71798098|NCT06034496|143096318|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
71798099|NCT06034496|143096318|SUPERIORITY|||||||0.53||||||CES main effect|ANOVA|||||||.53
71798100|NCT06034496|143096318|SUPERIORITY|||||||0.07||||||CES x Time interaction|ANOVA|||||||.07
71798101|NCT06034496|143096318|SUPERIORITY|||||||0.46||||||CES x Session|ANOVA|||||||.46
71798102|NCT06034496|143096318|SUPERIORITY|||||||0.01||||||Time x Session interaction|ANOVA|||||||.01
71798103|NCT06034496|143096318|SUPERIORITY|||||||0.29||||||CES x Time x Session interaction|ANOVA|||||||.29
71840684|NCT03952338|143190689|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.08|TWO_SIDED|95.0|-0.22|4.43|||Mixed Models Analysis|||||4.43|-0.22|0.08
71840685|NCT03952338|143190690|SUPERIORITY||Mean Difference (Final Values)|1.15||||0.09|TWO_SIDED|95.0|-0.17|2.46|||Mixed Models Analysis|||||2.46|-0.17|0.09
71674414|NCT00150488|142867374|OTHER|Compared to baseline|||||<|0.001|||||||Chi-squared|||||||<0.001
71798104|NCT06034496|143096319|SUPERIORITY|||||||0.1||||||CES main effect|ANOVA|||||||.10
71798105|NCT06034496|143096319|SUPERIORITY|||||||0||||||Time main effect|ANOVA|||||||.00
71798106|NCT06034496|143096319|SUPERIORITY|||||||0.81||||||Session main effect|ANOVA|||||||.81
71798107|NCT06034496|143096319|SUPERIORITY|||||||0.4||||||CES x Time interaction|ANOVA|||||||.40
71798108|NCT06034496|143096319|SUPERIORITY|||||||0.35||||||CES x Session interaction|ANOVA|||||||.35
71798109|NCT06034496|143096319|SUPERIORITY|||||||0||||||Time x Session interaction|ANOVA|||||||.00
71798110|NCT06034496|143096319|SUPERIORITY|||||||0.4||||||CES x Time x Session interaction|ANOVA|||||||.40
71798111|NCT06034496|143096320|SUPERIORITY|||||||0.23||||||STAI-T CES main effect|ANOVA|||||||.23
71798112|NCT06034496|143096320|SUPERIORITY|||||||0.45||||||STAI-T Session main effect|ANOVA|||||||.45
71798113|NCT06034496|143096320|SUPERIORITY|||||||0.38||||||STAI-T CES x Session interaction|ANOVA|||||||.38
71840686|NCT03952338|143190691|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.95|TWO_SIDED|95.0|-1.39|1.3|||Mixed Models Analysis|||||1.30|-1.39|0.95
71798114|NCT06034496|143096320|SUPERIORITY|||||||0.4||||||STAI-S CES main effect|ANOVA|||||||.40
71798115|NCT06034496|143096320|SUPERIORITY|||||||0||||||STAI-S Time main effect|ANOVA|||||||.00
71798116|NCT06034496|143096320|SUPERIORITY|||||||0||||||STAI-S Session main effect|ANOVA|||||||.00
71798117|NCT06034496|143096320|SUPERIORITY|||||||0.2||||||STAI-S CES x Time interaction|ANOVA|||||||.20
71798118|NCT06034496|143096320|SUPERIORITY|||||||0.39||||||STAI-S CES x Session interaction|ANOVA|||||||.39
71798119|NCT06034496|143096320|SUPERIORITY|||||||0||||||STAI-S Session x Time interaction|ANOVA|||||||.00
71798120|NCT06034496|143096320|SUPERIORITY|||||||0.38||||||STAI-S CES x Time x Session interaction|ANOVA|||||||.38
71798121|NCT06034496|143096321|SUPERIORITY|||||||0.85||||||CES main effect|ANOVA|||||||.85
71798122|NCT06034496|143096321|SUPERIORITY|||||||0.69||||||Session main effect|ANOVA|||||||.69
71798123|NCT06034496|143096321|SUPERIORITY|||||||0.4||||||CES x Session interaction|ANOVA|||||||.4
71798124|NCT06034496|143096322|SUPERIORITY|||||||0.13||||||CES main effect|ANOVA|||||||.13
71798125|NCT06034496|143096322|SUPERIORITY|||||||0.26||||||Session main effect|ANOVA|||||||.26
71798126|NCT06034496|143096322|SUPERIORITY|||||||0.44||||||CES x Session interaction|ANOVA|||||||.44
71798127|NCT06034496|143096323|SUPERIORITY|||||||0.36||||||CES main effect|ANOVA|||||||.36
71798128|NCT06034496|143096323|SUPERIORITY|||||||0||||||Session main effect|ANOVA|||||||.00
71798129|NCT06034496|143096323|SUPERIORITY|||||||0.96||||||CES x Session interaction|ANOVA|||||||.96
71798130|NCT03277261|143096356|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.406|||<|0.0001|TWO_SIDED|95.0|0.268|0.615||GEE (Generalized Estimating Equation) model for the relapse count per participant with logarithmic link function, treatment, region, and baseline Expanded Disability Status Scale (EDSS) strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.615|0.268|<0.0001
71798131|NCT03277261|143096357|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.033|||<|0.0001|TWO_SIDED|95.0|0.019|0.058||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.058|0.019|<0.0001
71798132|NCT03277261|143096358|SUPERIORITY||Rate Ratio (Ublituximab/Teriflunomide)|0.076|||<|0.0001|TWO_SIDED|95.0|0.056|0.104||GEE model for the relapse count per participant with logarithmic link function, treatment, region, and baseline EDSS strata as covariates and log (years of treatment) as offset.|Negative Binomial Model|||||0.104|0.056|<0.0001
71798133|NCT03277261|143096360|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|5.442|||<|0.0001|TWO_SIDED|95.0|3.536|8.375||Logistic regression model with treatment, region, baseline EDSS strata and log transformed baseline MRI lesion counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Regression, Logistic|||||8.375|3.536|<0.0001
71798134|NCT03277261|143096361|SUPERIORITY||Odds Ratio (Ublituximab/Teriflunomide)|0.872|||=|0.4669|TWO_SIDED|95.0|0.603|1.261||Logistic regression model with treatment, region, baseline EDSS strata, and log-transformed baseline MRI counts (T1 unenhancing, T2, Gd enhancing) as covariates.|Logistic Regression|||||1.261|0.603|=0.4669
71798135|NCT03277261|143096362|SUPERIORITY||Least squares mean difference|-0.072|||<|0.0001|TWO_SIDED|95.0|-0.107|-0.036||The model includes treatment, region, baseline EDSS strata, visit, treatment-by-visit interaction, and baseline volume (cube root transformed) as covariates and an unstructured covariance matrix.|Mixed Model Repeated Measures (MMRM)|||||-0.036|-0.107|<0.0001
71798136|NCT05944250|143096364|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
71798137|NCT05944250|143096368|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 1||||1
71798138|NCT05944250|143096368|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 2||||1
71798139|NCT05944250|143096368|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 3||||1
71798140|NCT05944250|143096368|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Wounds that reach \>50% healing from baseline per investigator assessment at Month 4||||0.15
71798141|NCT05944250|143096369|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 1||||1
71798142|NCT05944250|143096369|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 2||||1
71798143|NCT05944250|143096369|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 3||||0.59
71840687|NCT03952338|143190692|SUPERIORITY||Odds Ratio (OR)|0.21||||0.01|TWO_SIDED|95.0|0.06|0.7|||Regression, Logistic|||||0.70|0.06|0.01
71840688|NCT03952338|143190693|SUPERIORITY||Odds Ratio (OR)|0.29||||0.04|TWO_SIDED|95.0|0.09|0.96|||Regression, Logistic|||||0.96|0.09|0.04
71798144|NCT05944250|143096369|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Wounds that reach \>70% healing from baseline per investigator assessment at Month 4||||0.09
71798145|NCT02703636|143096375|OTHER|The MMRM model contained visit as a fixed effect, baseline MMSE score as a covariate and patient as a random effect.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.259||0.175|TWO_SIDED|95.0|-0.87|0.16|||t-test, 2 sided||change at week 24|||0.16|-0.87|0.1750
71798146|NCT00393939|143096383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9222||||0.2651|TWO_SIDED|95.0|0.7156|1.1885||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Independent radiology assessment||1.1885|0.7156|0.2651
71798147|NCT00393939|143096383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856||||0.0753|TWO_SIDED|95.0|0.6921|1.0589||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Investigator's assessment||1.0589|0.6921|0.0753
71798148|NCT00393939|143096384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.0018|TWO_SIDED|95.0|1.17|2.33||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Independent radiology assessment||2.33|1.17|0.0018
71798149|NCT00393939|143096384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0172|TWO_SIDED|95.0|1.03|2.02||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Investigator's assessment||2.02|1.03|0.0172
71798150|NCT00393939|143096386|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1539||||0.8933|TWO_SIDED|95.0|0.9209|1.4458||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||||1.4458|0.9209|0.8933
71798151|NCT02161718|143096392|SUPERIORITY||Hazard Ratio (HR)|0.91|STANDARD_ERROR_OF_MEAN|0.251||0.746|TWO_SIDED|95.0|0.53|1.56|||Log Rank|||||1.56|0.53|0.746
71798152|NCT02161718|143096393|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.372|TWO_SIDED|95.0|0.43|1.37|||Andersen-Gill Recurrent-Event Cox Model|||||1.37|0.43|0.372
71798153|NCT02161718|143096394|SUPERIORITY||Odds Ratio (OR)|0.99||||0.963|TWO_SIDED|95.0|0.56|1.73|||Regression, Logistic|||||1.73|0.56|0.963
71798154|NCT01857063|143096433|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.01||||0.913|TWO_SIDED|95.0|-0.11|0.1||Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|Longitudinal Data Analysis (LDA)|||||0.10|-0.11|0.913
71798155|NCT01857063|143096435|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.953|TWO_SIDED|95.0|-0.17|0.16||Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.16|-0.17|0.953
71798156|NCT01857063|143096436|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0||||0.974|TWO_SIDED|95.0|-0.07|0.07||Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.07|-0.07|0.974
71798157|NCT01857063|143096437|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.182|TWO_SIDED|95.0|-0.06|0.01||Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.01|-0.06|0.182
71798158|NCT01857063|143096438|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.161|TWO_SIDED|95.0|-0.01|0.05||Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA|||||0.05|-0.01|0.161
71798159|NCT04115358|143096451|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798160|NCT04115358|143096452|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798161|NCT04115358|143096453|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798162|NCT04115358|143096454|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798163|NCT04115358|143096455|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798164|NCT04115358|143096456|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798165|NCT04115358|143096457|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798166|NCT04115358|143096458|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798167|NCT04115358|143096459|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798168|NCT04115358|143096460|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71840689|NCT03952338|143190694|SUPERIORITY||Odds Ratio (OR)|2.11||||0.236|TWO_SIDED|95.0|0.27|7.23|||Regression, Logistic|||||7.23|0.27|0.236
71840690|NCT03952338|143190695|SUPERIORITY||Odds Ratio (OR)|2.22||||0.22|TWO_SIDED|95.0|0.62|7.97|||Regression, Logistic|||||7.97|0.62|0.220
71840691|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.7|TWO_SIDED|95.0|-0.37|0.55|||Mixed Models Analysis|||Total vegetables||0.55|-0.37|0.70
71840692|NCT03952338|143190696|SUPERIORITY||Median Difference (Final Values)|-0.07||||0.85|TWO_SIDED|95.0|-0.84|0.69|||Mixed Models Analysis|||Greens and beans||0.69|-0.84|0.85
71840693|NCT03952338|143190696|SUPERIORITY|Total fruits|Mean Difference (Final Values)|0.34||||0.29|TWO_SIDED|95.0|-0.29|0.98|||Mixed Models Analysis|||||0.98|-0.29|0.29
71840694|NCT03952338|143190696|SUPERIORITY||Median Difference (Final Values)|0.6||||0.07|TWO_SIDED|95.0|-0.06|1.26|||Mixed Models Analysis|||Whole fruits||1.26|-0.06|0.07
71840695|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.92|TWO_SIDED|95.0|-1.16|1.05|||Mixed Models Analysis|||Whole grains||1.05|-1.16|0.92
71840696|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED|95.0|-1.29|0.89|||Mixed Models Analysis|||Dairy||0.89|-1.29|0.72
71840697|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.15|TWO_SIDED|95.0|-0.12|0.74|||Mixed Models Analysis|||Total protein||0.74|-0.12|0.15
71674415|NCT03850483|142867375|SUPERIORITY||Least square (LS) mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1641|TWO_SIDED|90.0|-1.71|0.43||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.43|-1.71|0.1641
71798169|NCT04115358|143096461|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798170|NCT04115358|143096462|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798171|NCT04115358|143096463|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798172|NCT04115358|143096464|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798173|NCT04115358|143096465|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798174|NCT04115358|143096466|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71840698|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.92|TWO_SIDED|95.0|-0.78|0.71|||Mixed Models Analysis|||Seafood and plant proteins||0.71|-0.78|0.92
71798175|NCT04115358|143096467|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798176|NCT04115358|143096468|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798177|NCT04115358|143096469|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798178|NCT04115358|143096470|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798179|NCT04115358|143096471|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798180|NCT04115358|143096472|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798181|NCT04115358|143096473|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798182|NCT04115358|143096474|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798183|NCT04115358|143096475|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798184|NCT04115358|143096476|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798185|NCT04115358|143096477|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798186|NCT04115358|143096478|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798187|NCT04115358|143096479|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798188|NCT04115358|143096480|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798189|NCT04115358|143096481|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71798190|NCT04115358|143096482|SUPERIORITY||||||>|0.05|||||||Chi-squared|||Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p\<0,05.||||>0.05
71840699|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.67|TWO_SIDED|95.0|-1.47|0.94|||Mixed Models Analysis|||Fatty acids||0.94|-1.47|0.67
71840700|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.45|0.84|||Mixed Models Analysis|||Sodium||0.84|-1.45|0.61
71840701|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|-1.15||||0.06|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Analysis|||Refined grains||0.04|-2.34|0.06
71798191|NCT01205165|143096483|SUPERIORITY_OR_OTHER|||||||0||95.0||||P-value is calculated from Wilcoxon signed rank test to compare difference between baseline and week12|Wilcoxon signed rank test|||Baseline and Week 12||||0.00000
71798192|NCT02942017|143096495|SUPERIORITY||Least Square (LS) Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.019||0.016|TWO_SIDED|95.0|-4.52|-0.48|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.48|-4.52|0.0160
71840702|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.32|TWO_SIDED|95.0|-0.51|1.57|||Mixed Models Analysis|||Saturated fats||1.57|-0.51|0.32
71840703|NCT03952338|143190696|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.63|TWO_SIDED|95.0|-0.56|0.92|||Mixed Models Analysis|||Added sugars||0.92|-0.56|0.63
71798193|NCT02942017|143096496|SUPERIORITY||LS Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|1.271||0.671|TWO_SIDED|95.0|-1.98|3.07|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.07|-1.98|0.6710
71674416|NCT03850483|142867375|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.65||0.61|TWO_SIDED|90.0|-0.89|1.26||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||1.26|-0.89|0.6100
71674417|NCT03850483|142867375|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.65||0.1686|TWO_SIDED|90.0|-1.7|0.45||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.45|-1.70|0.1686
71674418|NCT03850483|142867375|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1051|TWO_SIDED|90.0|-1.87|0.25||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.25|-1.87|0.1051
71674419|NCT03850483|142867375|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.3583|TWO_SIDED|90.0|-1.37|0.88||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.88|-1.37|0.3583
71798194|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.738||0.4216|TWO_SIDED|95.0|-2.06|0.87|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.87|-2.06|0.4216
71798195|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.905||0.3947|TWO_SIDED|95.0|-2.57|1.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.02|-2.57|0.3947
71798196|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.962||0.328|TWO_SIDED|95.0|-2.86|0.96|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.96|-2.86|0.3280
71798197|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.994||0.2522|TWO_SIDED|95.0|-3.12|0.83|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-3.12|0.2522
71798198|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-1.61|STANDARD_ERROR_OF_MEAN|1.091||0.1431|TWO_SIDED|95.0|-3.78|0.55|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-3.78|0.1431
71798199|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|1.113||0.0991|TWO_SIDED|95.0|-4.06|0.36|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-4.06|0.0991
71798200|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|1.155||0.0389|TWO_SIDED|95.0|-4.71|-0.13|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-4.71|0.0389
71798201|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-3.48|STANDARD_ERROR_OF_MEAN|1.108||0.0022|TWO_SIDED|95.0|-5.67|-1.28|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.28|-5.67|0.0022
71798202|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.429||0.0255|TWO_SIDED|95.0|-6.08|-0.4|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.40|-6.08|0.0255
71674420|NCT03850483|142867375|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.1131|TWO_SIDED|90.0|-1.88|0.29||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.29|-1.88|0.1131
71674421|NCT03850483|142867375|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.64||0.1812|TWO_SIDED|90.0|-1.64|0.47||Multiplicity adjustment comparing 6 different treatment arms was performed only for the primary endpoint using Hochberg step-up procedure to maintain overall familywise error rate at 5% level.|ANCOVA|||||0.47|-1.64|0.1812
71674422|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
71674423|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|8.5||||0.243|TWO_SIDED|90.0|-6.6|25.9|||Chan and Zhang method|||||25.9|-6.6|0.2430
71674424|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|3.4||||0.3747|TWO_SIDED|90.0|-10.6|17.9|||Chan and Zhang method|||||17.9|-10.6|0.3747
71798203|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-2.03|STANDARD_ERROR_OF_MEAN|1.356||0.1375|TWO_SIDED|95.0|-4.73|0.66|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.66|-4.73|0.1375
71798204|NCT02942017|143096497|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.4||0.817|TWO_SIDED|95.0|-3.11|2.46|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.46|-3.11|0.8170
71798205|NCT02942017|143096498|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0168|TWO_SIDED|95.0|1.2|6.7|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.7|1.2|0.0168
71798206|NCT02942017|143096498|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0482|TWO_SIDED|95.0|1.0|6.6|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.||6.6|1.0|0.0482
71840704|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.85|TWO_SIDED|95.0|-0.61|0.5|||Mixed Models Analysis|||Total vegetables||0.50|-0.61|0.85
71840705|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.82|TWO_SIDED|95.0|-0.88|0.7|||Mixed Models Analysis|||Greens and beans||0.70|-0.88|0.82
71840706|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.48|TWO_SIDED|95.0|-0.43|0.93|||Mixed Models Analysis|||Total fruits||0.93|-0.43|0.48
71840707|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|0.71||||0.06|TWO_SIDED|95.0|-0.04|1.46|||Mixed Models Analysis|||Whole fruits||1.46|-0.04|0.06
71674425|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|14.5||||0.0665|TWO_SIDED|0.0665|-1.3|31.5|||Chan and Zhang method|||||31.5|-1.3|0.0665
71798207|NCT02942017|143096498|SUPERIORITY||Odds Ratio (OR)|0.8||||0.5857|TWO_SIDED|95.0|0.3|2.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||2.0|0.3|0.5857
71798208|NCT02942017|143096499|SUPERIORITY||Odds Ratio (OR)|3.4||||0.0033|TWO_SIDED|95.0|1.5|7.9||Hour 60:|GEE method|||Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.9|1.5|0.0033
71798209|NCT02942017|143096499|SUPERIORITY||Odds Ratio (OR)|3.7||||0.0046|TWO_SIDED|95.0|1.5|9.3|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||9.3|1.5|0.0046
71840708|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.34|TWO_SIDED|95.0|-0.63|1.84|||Mixed Models Analysis|||Whole grains||1.84|-0.63|0.34
71840709|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.01|TWO_SIDED|95.0|0.31|2.62|||Mixed Models Analysis|||Dairy||2.62|0.31|0.01
71840710|NCT03952338|143190697|SUPERIORITY||Median Difference (Final Values)|0.21||||0.39|TWO_SIDED|95.0|-0.27|0.69|||Mixed Models Analysis|||Total protein||0.69|-0.27|0.39
71840711|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.81|TWO_SIDED|95.0|-0.9|0.7|||Mixed Models Analysis|||Seafood and plant proteins||0.70|-0.90|0.81
71840712|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.04|TWO_SIDED|95.0|-2.57|-0.04|||Mixed Models Analysis|||Fatty acids||-0.04|-2.57|0.04
71840713|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.25|TWO_SIDED|95.0|-1.86|0.48|||Mixed Models Analysis|||Sodium||0.48|-1.86|0.25
71840714|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.91|TWO_SIDED|95.0|-1.25|1.4|||Mixed Models Analysis|||Refined grains||1.40|-1.25|0.91
71840715|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.89|TWO_SIDED|95.0|-0.98|1.13|||Mixed Models Analysis|||Saturated fats||1.13|-0.98|0.89
71840716|NCT03952338|143190697|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.59|TWO_SIDED|95.0|-0.55|0.97|||Mixed Models Analysis|||Added sugars||0.97|-0.55|0.59
71840717|NCT03952338|143190698|SUPERIORITY||Risk Ratio (RR)|0.15||||0.01|TWO_SIDED|95.0|0.03|0.67||Marginal food insecurity|Mixed Models Analysis|Mixed effects multinomial logistic regression||||0.67|0.03|0.01
71674426|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|6.1||||0.3423|TWO_SIDED|90.0|-12.1|25.5|||Chan and Zhang method|||||25.5|-12.1|0.3423
71674427|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|12.9||||0.1271|TWO_SIDED|90.0|-4.7|30.9|||Chan and Zhang method|||||30.9|-4.7|0.1271
71674428|NCT03850483|142867376|SUPERIORITY||Risk Difference (RD)|3.2||||0.401|TWO_SIDED|90.0|-13.2|21.1|||Chan and Zhang method|||||21.1|-13.2|0.4010
71674429|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4225|TWO_SIDED|90.0|-11.2|10.4|||Chan and Zhang method|||Week 1||10.4|-11.2|0.4225
71674430|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 1||5.0|-14.0|0.7483
71798210|NCT02942017|143096499|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3085|TWO_SIDED|95.0|0.3|1.5|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||1.5|0.3|0.3085
71798211|NCT02942017|143096500|SUPERIORITY||LS mean difference|-8.35|STANDARD_ERROR_OF_MEAN|2.989||0.0063|TWO_SIDED|95.0|-14.29|-2.42|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.42|-14.29|0.0063
71798212|NCT02942017|143096500|SUPERIORITY||LS mean difference|-9.75|STANDARD_ERROR_OF_MEAN|3.566||0.0074|TWO_SIDED|95.0|-16.83|-2.68|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.68|-16.83|0.0074
71798213|NCT02942017|143096500|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|3.149||0.6637|TWO_SIDED|95.0|-4.88|7.63|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||7.63|-4.88|0.6637
71798214|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.5132|TWO_SIDED|95.0|-0.41|0.21|||MMRM|||Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.41|0.5132
71798215|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.181||0.1672|TWO_SIDED|95.0|-0.61|0.11|||MMRM|||Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.61|0.1672
71798216|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.178||0.0963|TWO_SIDED|95.0|-0.65|0.05|||MMRM|||Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.65|0.0963
71798217|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.183||0.4803|TWO_SIDED|95.0|-0.49|0.23|||MMRM|||Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.49|0.4803
71798218|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.191||0.0844|TWO_SIDED|95.0|-0.71|0.05|||MMRM|||Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.71|0.0844
71674431|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
71798219|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.193||0.1325|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1325
71798220|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.192||0.0332|TWO_SIDED|95.0|-0.79|-0.03|||MMRM|||Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.79|0.0332
71674432|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 1||4.8|-14.0|0.7539
71798221|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.189||0.1273|TWO_SIDED|95.0|-0.67|0.08|||MMRM|||Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.67|0.1273
71798222|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.182||0.1059|TWO_SIDED|95.0|-0.66|0.06|||MMRM|||Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.66|0.1059
71798223|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.215||0.0683|TWO_SIDED|95.0|-0.82|0.03|||MMRM|||Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.82|0.0683
71798224|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4458|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4458
71798225|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.228||0.2905|TWO_SIDED|95.0|-0.21|0.7|||MMRM|||Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.70|-0.21|0.2905
71798226|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.182||0.3096|TWO_SIDED|95.0|-0.18|0.55|||MMRM|||Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.18|0.3096
71798227|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.165||0.1925|TWO_SIDED|95.0|-0.55|0.11|||MMRM|||Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.55|0.1925
71798228|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.168||0.0101|TWO_SIDED|95.0|-0.77|-0.11|||MMRM|||Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.77|0.0101
71798229|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.1546|TWO_SIDED|95.0|-0.56|0.09|||MMRM|||Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.56|0.1546
71798230|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.168||0.0901|TWO_SIDED|95.0|-0.62|0.05|||MMRM|||Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.62|0.0901
71798231|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.162||0.0717|TWO_SIDED|95.0|-0.62|0.03|||MMRM|||Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.62|0.0717
71798232|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.169||0.0468|TWO_SIDED|95.0|-0.68|0.0|||MMRM|||Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.68|0.0468
71813528|NCT01061333|143129417|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.5|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.50|<0.0001
71840718|NCT03952338|143190698|SUPERIORITY||Risk Ratio (RR)|0.56||||0.34|TWO_SIDED|95.0|0.17|1.82|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||1.82|0.17|0.34
71674433|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-6.4|8.9|||Chan and Zhang method|||Week 1||8.9|-6.4|0.5000
71674434|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|2.9||||0.2125|TWO_SIDED|90.0|-3.4|13.2|||Chan and Zhang method|||Week 1||13.2|-3.4|0.2125
71674435|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|2.7||||0.2267|TWO_SIDED|90.0|-3.5|12.2|||Chan and Zhang method|||Week 1||12.2|-3.5|0.2267
71798233|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.173||0.2222|TWO_SIDED|95.0|-0.56|0.13|||MMRM|||Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.56|0.2222
71674436|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7592|TWO_SIDED|90.0|-14.0|4.6|||Chan and Zhang method|||Week 2||4.6|-14.0|0.7592
71674437|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7299|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 2||5.5|-14.0|0.7299
71674438|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4463|TWO_SIDED|90.0|-11.3|9.4|||Chan and Zhang method|||Week 2||9.4|-11.3|0.4463
71798234|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.156||0.0682|TWO_SIDED|95.0|-0.6|0.02|||MMRM|||Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.60|0.0682
71813529|NCT01061333|143129417|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|TWO_SIDED|90.0|0.49|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.70|0.49|<0.0001
71674439|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7539|TWO_SIDED|90.0|-14.0|4.8|||Chan and Zhang method|||Week 2||4.8|-14.0|0.7539
71674440|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-2.2||||0.7009|TWO_SIDED|90.0|-10.1|5.9|||Chan and Zhang method|||Week 2||5.9|-10.1|0.7009
71674441|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|4.0||||0.2507|TWO_SIDED|90.0|-4.5|15.6|||Chan and Zhang method|||Week 2||15.6|-4.5|0.2507
71674442|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|3.5||||0.2993|TWO_SIDED|90.0|-4.8|14.3|||Chan and Zhang method|||Week 2||14.3|-4.8|0.2993
71674443|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7363|TWO_SIDED|90.0|-14.0|5.5|||Chan and Zhang method|||Week 4||5.5|-14.0|0.7363
71798235|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0147|TWO_SIDED|95.0|-0.72|-0.08|||MMRM|||Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.72|0.0147
71798236|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.182||0.0837|TWO_SIDED|95.0|-0.68|0.04|||MMRM|||Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.68|0.0837
71798237|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.179||0.5828|TWO_SIDED|95.0|-0.46|0.26|||MMRM|||Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.46|0.5828
71798238|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.168||0.5674|TWO_SIDED|95.0|-0.43|0.24|||MMRM|||Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.43|0.5674
71798239|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.145||0.4613|TWO_SIDED|95.0|-0.18|0.4|||MMRM|||Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.18|0.4613
71798240|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.324|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3240
71798241|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.082||0.3023|TWO_SIDED|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.24|0.3023
71798242|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.4127|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.4127
71798243|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.2819|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2819
71798244|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3884|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3884
71840719|NCT03952338|143190698|SUPERIORITY||Risk Ratio (RR)|0.16||||0.02|TWO_SIDED|95.0|0.03|0.76|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.76|0.03|0.02
71840720|NCT03952338|143190699|SUPERIORITY||Risk Ratio, log|0.28||||0.1|TWO_SIDED|95.0|0.06|1.29|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Marginal food insecurity||1.29|0.06|0.10
71840721|NCT03952338|143190699|SUPERIORITY||Risk Ratio (RR)|0.68||||0.52|TWO_SIDED|95.0|0.21|2.21|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Moderate food insecurity||2.21|0.21|0.52
71840722|NCT03952338|143190699|SUPERIORITY||Risk Ratio (RR)|0.11||||0.01|TWO_SIDED|95.0|0.02|0.56|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Severe food insecurity||0.56|0.02|0.01
71840723|NCT03952338|143190700|SUPERIORITY||Risk Ratio (RR)|2.94||||0.15|TWO_SIDED|95.0|0.68|12.66|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||12.66|0.68|0.15
71840724|NCT03952338|143190700|SUPERIORITY||Risk Ratio (RR)|1.18||||0.86|TWO_SIDED|95.0|0.2|7.13|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||7.13|0.20|0.86
71840725|NCT03952338|143190701|SUPERIORITY||Risk Ratio (RR)|1.28||||0.74|TWO_SIDED|95.0|0.31|5.38|||Mixed Models Analysis|Mixed effects multinomial logistic regression||Medium malnutrition risk||5.38|0.31|0.74
71674444|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|0.4||||0.5369|TWO_SIDED|90.0|-10.5|12.3|||Chan and Zhang method|||Week 4||12.3|-10.5|0.5369
71674445|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
71674446|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.7483|TWO_SIDED|90.0|-14.0|5.0|||Chan and Zhang method|||Week 4||5.0|-14.0|0.7483
71798245|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.082||0.275|TWO_SIDED|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.25|0.2750
71798246|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.082||0.1811|TWO_SIDED|95.0|-0.27|0.05|||MMRM|||Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.27|0.1811
71798247|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3854|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3854
71798248|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.082||0.3822|TWO_SIDED|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.23|0.3822
71798249|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.082||0.9255|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.9255
71798250|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.091||0.6714|TWO_SIDED|95.0|-0.14|0.22|||MMRM|||Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.14|0.6714
71798251|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.091||0.9838|TWO_SIDED|95.0|-0.18|0.18|||MMRM|||Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.18|0.9838
71798252|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.083||0.8884|TWO_SIDED|95.0|-0.17|0.15|||MMRM|||Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.17|0.8884
71798253|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.6996|TWO_SIDED|95.0|-0.23|0.16|||MMRM|||Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.23|0.6996
71813530|NCT01061333|143129417|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.87||||0.2679|TWO_SIDED|90.0|0.69|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.69|0.2679
71813531|NCT01061333|143129418|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.9||||0.7622|TWO_SIDED|90.0|0.51|1.59||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.59|0.51|0.7622
71813532|NCT01061333|143129418|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.94||||0.8468|TWO_SIDED|90.0|0.53|1.65||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated on log scale||||1.65|0.53|0.8468
71674447|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-2.2||||0.599|TWO_SIDED|90.0|-13.7|11.6|||Chan and Zhang method|||Week 4||11.6|-13.7|0.5990
71674448|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-5.9||||0.7926|TWO_SIDED|90.0|-16.4|4.9|||Chan and Zhang method|||Week 4||4.9|-16.4|0.7926
71674449|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|3.2||||0.3402|TWO_SIDED|90.0|-9.0|17.6|||Chan and Zhang method|||Week 4||17.6|-9.0|0.3402
71674450|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.2||||0.7364|TWO_SIDED|90.0|-14.4|5.7|||Chan and Zhang method|||Week 6||5.7|-14.4|0.7364
71674451|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|4.2||||0.3009|TWO_SIDED|90.0|-7.4|17.7|||Chan and Zhang method|||Week 6||17.7|-7.4|0.3009
71674452|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|3.2||||0.34|TWO_SIDED|90.0|-8.1|15.9|||Chan and Zhang method|||Week 6||15.9|-8.1|0.3400
71798254|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4426|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4426
71798255|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.8743|TWO_SIDED|95.0|-0.2|0.24|||MMRM|||Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.20|0.8743
71798256|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.118||0.3498|TWO_SIDED|95.0|-0.12|0.35|||MMRM|||Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.12|0.3498
71798257|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.151||0.0839|TWO_SIDED|95.0|-0.56|0.04|||MMRM|||Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.56|0.0839
71798258|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.157||0.2595|TWO_SIDED|95.0|-0.49|0.13|||MMRM|||Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.49|0.2595
71798259|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.168||0.056|TWO_SIDED|95.0|-0.66|0.01|||MMRM|||Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.66|0.0560
71674453|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|7.1||||0.1631|TWO_SIDED|90.0|-4.8|21.1|||Chan and Zhang method|||Week 6||21.1|-4.8|0.1631
71798260|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.18||0.6187|TWO_SIDED|95.0|-0.45|0.27|||MMRM|||Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.45|0.6187
71798261|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.163||0.0187|TWO_SIDED|95.0|-0.72|-0.07|||MMRM|||Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.72|0.0187
71798262|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.18||0.1531|TWO_SIDED|95.0|-0.62|0.1|||MMRM|||Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.62|0.1531
71798263|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.197||0.3341|TWO_SIDED|95.0|-0.58|0.2|||MMRM|||Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.58|0.3341
71840726|NCT03952338|143190701|SUPERIORITY||Risk Ratio (RR)|5.48||||0.1|TWO_SIDED|95.0|0.73|41.3|||Mixed Models Analysis|Mixed effects multinomial logistic regression||High malnutrition risk||41.3|0.73|0.10
71840727|NCT03952338|143190702|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.64|TWO_SIDED|95.0|-0.65|0.4|||Mixed Models Analysis|||||0.40|-0.65|0.64
71840728|NCT03952338|143190703|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.9|TWO_SIDED|95.0|-0.57|0.5|||Mixed Models Analysis|||||0.50|-0.57|0.90
71840729|NCT03952338|143190704|SUPERIORITY||Mean Difference (Final Values)|-4.07||||0.43|TWO_SIDED|95.0|-14.05|5.92||Males|Mixed Models Analysis|||||5.92|-14.05|0.43
71674454|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
71674455|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6214|TWO_SIDED|90.0|-17.8|13.0|||Chan and Zhang method|||Week 6||13.0|-17.8|0.6214
71674456|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.5||||0.6413|TWO_SIDED|90.0|-17.9|11.7|||Chan and Zhang method|||Week 6||11.7|-17.9|0.6413
71674457|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-13.1|13.1|||Chan and Zhang method|||Week 8||13.1|-13.1|0.5000
71798264|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.216||0.8969|TWO_SIDED|95.0|-0.4|0.46|||MMRM|||Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.40|0.8969
71798265|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.174||0.5862|TWO_SIDED|95.0|-0.25|0.44|||MMRM|||Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.25|0.5862
71798266|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.117||0.3776|TWO_SIDED|95.0|-0.13|0.34|||MMRM|||Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.13|0.3776
71798267|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9029|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.9029
71798268|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.121||0.6173|TWO_SIDED|95.0|-0.18|0.3|||MMRM|||Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.18|0.6173
71798269|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.124||0.2433|TWO_SIDED|95.0|-0.1|0.39|||MMRM|||Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.10|0.2433
71798270|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.139||0.0234|TWO_SIDED|95.0|-0.59|-0.04|||MMRM|||Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.59|0.0234
71798271|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.139||0.054|TWO_SIDED|95.0|-0.55|0.0|||MMRM|||Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.55|0.0540
71798272|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.144||0.0406|TWO_SIDED|95.0|-0.58|-0.01|||MMRM|||Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.58|0.0406
71798273|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.132||0.0295|TWO_SIDED|95.0|-0.56|-0.03|||MMRM|||Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.56|0.0295
71798274|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.0925|TWO_SIDED|95.0|-0.5|0.04|||MMRM|||Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.50|0.0925
71813533|NCT01061333|143129418|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.91||||0.614|TWO_SIDED|90.0|0.65|1.26||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.26|0.65|0.6140
71813534|NCT01061333|143129419|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.67||||0.0006|TWO_SIDED|90.0|0.57|0.8||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.80|0.57|0.0006
71674458|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|0.7||||0.5134|TWO_SIDED|90.0|-12.6|15.2|||Chan and Zhang method|||Week 8||15.2|-12.6|0.5134
71674459|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4468|TWO_SIDED|90.0|-13.4|12.5|||Chan and Zhang method|||Week 8||12.5|-13.4|0.4468
71840730|NCT03952338|143190704|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.83|TWO_SIDED|95.0|-3.75|4.66|||Mixed Models Analysis|||Females||4.66|-3.75|0.83
71840731|NCT03952338|143190705|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.66|TWO_SIDED|95.0|-5.65|3.57||Age 18-59 years|Mixed Models Analysis|||||3.57|-5.65|0.66
71840732|NCT03952338|143190705|SUPERIORITY||Mean Difference (Final Values)|3.28||||0.4|TWO_SIDED|95.0|-4.36|10.93|||Mixed Models Analysis|||Age 60+ years||10.93|-4.36|0.40
71840733|NCT03952338|143190706|SUPERIORITY||Mean Difference (Final Values)|6.25||||0.43|TWO_SIDED|95.0|-9.13|21.63|||Mixed Models Analysis|||Males||21.63|-9.13|0.43
71840734|NCT03952338|143190706|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.62|TWO_SIDED|95.0|-3.23|5.41|||Mixed Models Analysis|||Females||5.41|-3.23|0.62
71840735|NCT03952338|143190707|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.99|TWO_SIDED|95.0|-4.76|4.66|||Mixed Models Analysis|||18-59 years||4.66|-4.76|0.99
71840736|NCT03952338|143190707|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.43|TWO_SIDED|95.0|-5.48|12.8|||Mixed Models Analysis|||60+ years||12.80|-5.48|0.43
71840737|NCT05274074|143190745|SUPERIORITY||Mean Difference (Net)|1.4||||0.57|TWO_SIDED|95.0|-3.4|6.2|||Regression, Linear|||||6.2|-3.4|0.57
71674460|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|7.6||||0.2778|TWO_SIDED|90.0|-6.8|23.9|||Chan and Zhang method|||Week 8||23.9|-6.8|0.2778
71674461|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|2.1||||0.4571|TWO_SIDED|90.0|-14.5|21.0|||Chan and Zhang method|||Week 8||21.0|-14.5|0.4571
71674462|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4741|TWO_SIDED|90.0|-15.3|16.7|||Chan and Zhang method|||Week 8||16.7|-15.3|0.4741
71674463|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|0.4||||0.5153|TWO_SIDED|90.0|-14.8|16.7|||Chan and Zhang method|||Week 8||16.7|-14.8|0.5153
71840738|NCT05274074|143190746|SUPERIORITY||Mean Difference (Net)|-0.1||||0.53|TWO_SIDED|95.0|-0.5|0.2|||Regression, Linear|||||0.2|-0.5|0.53
71840739|NCT05274074|143190747|SUPERIORITY||Mean Difference (Net)|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.4|||Regression, Linear|||||1.4|-3.3|0.41
71840740|NCT05274074|143190748|SUPERIORITY||Mean Difference (Net)|-0.9||||0.45|TWO_SIDED|95.0|-3.5|1.6|||Regression, Linear|||||1.6|-3.5|0.45
71840741|NCT05274074|143190749|SUPERIORITY||Mean Difference (Net)|3.3||||0.02|TWO_SIDED|95.0|0.5|6.2|||Regression, Linear|||||6.2|0.5|0.02
71840742|NCT05274074|143190750|SUPERIORITY||Mean Difference (Net)|-0.8||||0.69|TWO_SIDED|95.0|-4.9|3.3|||Regression, Linear|||||3.3|-4.9|0.69
71840743|NCT01828099|143190783|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.001|TWO_SIDED|95.0|0.42|0.73|||Log Rank|||||0.73|0.42|<0.001
71840744|NCT01922050|143190822|SUPERIORITY||Rate ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.69|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.69|0.40|<0.001
71840745|NCT01922050|143190822|SUPERIORITY||Rate ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.35|0.61|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.61|0.35|<0.001
71840746|NCT01922050|143190822|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.28|0.48|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.48|0.28|<0.001
71840747|NCT01922050|143190822|SUPERIORITY||Rate ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.17|0.66|0.38
71840748|NCT01922050|143190822|SUPERIORITY||Rate ratio|0.69||||0.013|TWO_SIDED|95.0|0.52|0.93|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||0.93|0.52|0.013
71840749|NCT01922050|143190822|SUPERIORITY||Rate ratio|0.79||||0.13|TWO_SIDED|95.0|0.58|1.07|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.||||1.07|0.58|0.13
71840750|NCT01922050|143190823|SUPERIORITY||Ratio of clearance rates|0.74||||0.57|TWO_SIDED|95.0|0.27|2.04|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.04|0.27|0.57
71840751|NCT01922050|143190823|SUPERIORITY||Ratio of clearance rates|1.33||||0.51|TWO_SIDED|95.0|0.56|3.13|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||3.13|0.56|0.51
71840752|NCT01922050|143190823|SUPERIORITY||Ratio of clearance rates|1.9||||0.11|TWO_SIDED|95.0|0.86|4.21|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.21|0.86|0.11
71840753|NCT01922050|143190823|SUPERIORITY||Ratio of clearance rates|1.79||||0.21|TWO_SIDED|95.0|0.72|4.43|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||4.43|0.72|0.21
71798275|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.152||0.1631|TWO_SIDED|95.0|-0.52|0.09|||MMRM|||Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.52|0.1631
71798276|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.185||0.2213|TWO_SIDED|95.0|-0.6|0.14|||MMRM|||Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.60|0.2213
71798277|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.189||0.9175|TWO_SIDED|95.0|-0.36|0.39|||MMRM|||Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.36|0.9175
71798278|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.165||0.6763|TWO_SIDED|95.0|-0.4|0.26|||MMRM|||Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.40|0.6763
71798279|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.121||0.3805|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3805
71798280|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.127||0.6073|TWO_SIDED|95.0|-0.19|0.32|||MMRM|||Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.19|0.6073
71798281|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.119||0.7848|TWO_SIDED|95.0|-0.27|0.2|||MMRM|||Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.27|0.7848
71798282|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.121||0.9038|TWO_SIDED|95.0|-0.25|0.23|||MMRM|||Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.25|0.9038
71798283|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.134|STANDARD_ERROR_OF_MEAN|0.134||0.6869|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6869
71798284|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.139||0.9272|TWO_SIDED|95.0|-0.26|0.29|||MMRM|||Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.26|0.9272
71798285|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.131||0.6931|TWO_SIDED|95.0|-0.31|0.21|||MMRM|||Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.31|0.6931
71798286|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.132||0.8262|TWO_SIDED|95.0|-0.29|0.23|||MMRM|||Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.29|0.8262
71813535|NCT01061333|143129419|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.79||||0.0291|TWO_SIDED|90.0|0.67|0.94||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||0.94|0.67|0.0291
71674464|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-7.0||||0.8287|TWO_SIDED|90.0|-21.1|5.3|||Chan and Zhang method|||Week 10||5.3|-21.1|0.8287
71674465|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-2.3||||0.5675|TWO_SIDED|90.0|-17.8|14.2|||Chan and Zhang method|||Week 10||14.2|-17.8|0.5675
71674466|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|6.9||||0.2648|TWO_SIDED|90.0|-9.8|23.2|||Chan and Zhang method|||Week 10||23.2|-9.8|0.2648
71674467|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|3.9||||0.3792|TWO_SIDED|90.0|-11.8|20.8|||Chan and Zhang method|||Week 10||20.8|-11.8|0.3792
71674468|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|2.7||||0.4438|TWO_SIDED|90.0|-16.3|23.1|||Chan and Zhang method|||Week 10||23.1|-16.3|0.4438
71674469|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-7.5||||0.7014|TWO_SIDED|90.0|-23.3|9.4|||Chan and Zhang method|||Week 10||9.4|-23.3|0.7014
71674470|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-2.8||||0.5841|TWO_SIDED|90.0|-19.7|15.0|||Chan and Zhang method|||Week 10||15.0|-19.7|0.5841
71798287|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.141||0.0749|TWO_SIDED|95.0|-0.54|0.03|||MMRM|||Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.54|0.0749
71798288|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.135||0.1923|TWO_SIDED|95.0|-0.45|0.09|||MMRM|||Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.45|0.1923
71798289|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.176||0.0326|TWO_SIDED|95.0|-0.73|-0.03|||MMRM|||Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.73|0.0326
71798290|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.171||0.444|TWO_SIDED|95.0|-0.47|0.21|||MMRM|||Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.47|0.4440
71798291|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.134||0.7057|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7057
71798292|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.137||0.2865|TWO_SIDED|95.0|-0.42|0.13|||MMRM|||Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.42|0.2865
71674471|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-15.3|15.3|||Chan and Zhang method|||Week 12||15.3|-15.3|0.5000
71813536|NCT01061333|143129419|SUPERIORITY_OR_OTHER||Geom. Mean Ratio of fold over baseline|0.92||||0.3738|TWO_SIDED|90.0|0.77|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale||||1.08|0.77|0.3738
71674472|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5834|TWO_SIDED|90.0|-17.5|12.3|||Chan and Zhang method|||Week 12||12.3|-17.5|0.5834
71674473|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|10.3||||0.1534|TWO_SIDED|90.0|-6.4|27.2|||Chan and Zhang method|||Week 12||27.2|-6.4|0.1534
71674474|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|7.5||||0.272|TWO_SIDED|90.0|-8.8|24.9|||Chan and Zhang method|||Week 12||24.9|-8.8|0.2720
71674475|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-8.1||||0.6815|TWO_SIDED|90.0|-25.1|10.4|||Chan and Zhang method|||Week 12||10.4|-25.1|0.6815
71674476|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|3.5||||0.39|TWO_SIDED|90.0|-14.4|22.0|||Chan and Zhang method|||Week 12||22.0|-14.4|0.3900
71674477|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-2.7||||0.5865|TWO_SIDED|90.0|-20.0|15.9|||Chan and Zhang method|||Week 12||15.9|-20.0|0.5865
71674478|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|4.2||||0.3087|TWO_SIDED|90.0|-8.2|18.9|||Chan and Zhang method|||Week 14||18.9|-8.2|0.3087
71674479|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|5.2||||0.3137|TWO_SIDED|90.0|-8.2|20.9|||Chan and Zhang method|||Week 14||20.9|-8.2|0.3137
71674480|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|18.0||||0.0245|TWO_SIDED|90.0|2.7|34.8|||Chan and Zhang method|||Week 14||34.8|2.7|0.0245
71674481|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|10.8||||0.1119|TWO_SIDED|90.0|-3.0|26.0|||Chan and Zhang method|||Week 14||26.0|-3.0|0.1119
71674482|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|2.7||||0.414|TWO_SIDED|90.0|-13.2|20.4|||Chan and Zhang method|||Week 14||20.4|-13.2|0.4140
71674483|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|9.7||||0.2356|TWO_SIDED|90.0|-7.2|28.5|||Chan and Zhang method|||Week 14||28.5|-7.2|0.2356
71674484|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|4.5||||0.3638|TWO_SIDED|90.0|-11.5|21.5|||Chan and Zhang method|||Week 14||21.5|-11.5|0.3638
71798293|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9475|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9475
71798294|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.185||0.188|TWO_SIDED|95.0|-0.61|0.12|||MMRM|||Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.61|0.1880
71798295|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.595|TWO_SIDED|95.0|-0.51|0.29|||MMRM|||Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.51|0.5950
71798296|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.2||0.9636|TWO_SIDED|95.0|-0.39|0.41|||MMRM|||Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-0.39|0.9636
71798297|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.196||0.5836|TWO_SIDED|95.0|-0.5|0.28|||MMRM|||Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.50|0.5836
71798298|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.184||0.1568|TWO_SIDED|95.0|-0.63|0.1|||MMRM|||Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.63|0.1568
71798299|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.177||0.0155|TWO_SIDED|5.0|-0.79|-0.09|||Wilcoxon (Mann-Whitney)|||Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.79|0.0155
71798300|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.192||0.0504|TWO_SIDED|95.0|-0.76|0.0|||MMRM|||Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.76|0.0504
71798301|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.212||0.1865|TWO_SIDED|95.0|-0.7|0.14|||MMRM|||Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.70|0.1865
71798302|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.22||0.0518|TWO_SIDED|95.0|-0.87|0.0|||MMRM|||Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.87|0.0518
71798303|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.239||0.833|TWO_SIDED|95.0|-0.42|0.53|||MMRM|||Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.42|0.8330
71813537|NCT01061333|143129420|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.7501||90.0|0.88|1.2||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.20|0.88|0.7501
71674485|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|7.7||||0.1613|TWO_SIDED|90.0|-5.2|22.9|||Chan and Zhang method|||Week 16||22.9|-5.2|0.1613
71674486|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|13.9||||0.0557|TWO_SIDED|90.0|-0.5|31.4|||Chan and Zhang method|||Week 16||31.4|-0.5|0.0557
71798304|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.191||0.844|TWO_SIDED|95.0|-0.34|0.42|||MMRM|||Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.34|0.8440
71798305|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.121||0.4602|TWO_SIDED|95.0|-0.15|0.33|||MMRM|||Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.15|0.4602
71798306|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.117||0.0891|TWO_SIDED|95.0|-0.03|0.43|||MMRM|||Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.03|0.0891
71798307|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.117||0.3088|TWO_SIDED|95.0|-0.11|0.35|||MMRM|||Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.11|0.3088
71798308|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.112||0.856|TWO_SIDED|95.0|-0.24|0.2|||MMRM|||Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.24|0.8560
71798309|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.125||0.9702|TWO_SIDED|95.0|-0.24|0.25|||MMRM|||Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.24|0.9702
71798310|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8001|TWO_SIDED|95.0|-0.25|0.2|||MMRM|||Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.25|0.8001
71813538|NCT01061333|143129420|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.01||||0.941|TWO_SIDED|90.0|0.81|1.25||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.25|0.81|0.9410
71674487|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|21.6||||0.0114|TWO_SIDED|90.0|5.6|38.3|||Chan and Zhang method|||Week 16||38.3|5.6|0.0114
71674488|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|11.9||||0.0753|TWO_SIDED|90.0|-1.8|28.1|||Chan and Zhang method|||Week 16||28.1|-1.8|0.0753
71674489|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.1||||0.5635|TWO_SIDED|90.0|-20.1|15.2|||Chan and Zhang method|||Week 16||15.2|-20.1|0.5635
71813539|NCT01061333|143129420|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.89||||0.1165|TWO_SIDED|90.0|0.79|1.01||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.01|0.79|0.1165
71813540|NCT01061333|143129421|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.03||||0.8616|TWO_SIDED|90.0|0.76|1.41||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.41|0.76|0.8616
71813541|NCT01061333|143129421|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.06||||0.7512|TWO_SIDED|90.0|0.77|1.45||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.45|0.77|0.7512
71813542|NCT01061333|143129421|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|0.99||||0.9723|TWO_SIDED|90.0|0.72|1.37||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.37|0.72|0.9723
71674490|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-3.6||||0.6201|TWO_SIDED|90.0|-20.3|14.5|||Chan and Zhang method|||Week 16||14.5|-20.3|0.6201
71674491|NCT03850483|142867377|SUPERIORITY||Risk Difference (RD)|-0.7||||0.4792|TWO_SIDED|90.0|-17.6|17.0|||Chan and Zhang method|||Week 16||17.0|-17.6|0.4792
71813543|NCT01061333|143129422|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.3||||0.1983|TWO_SIDED|90.0|0.92|1.82||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.82|0.92|0.1983
71813544|NCT01061333|143129422|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.57||||0.0872|TWO_SIDED|90.0|1.02|2.42||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||2.42|1.02|0.0872
71813545|NCT01061333|143129422|SUPERIORITY_OR_OTHER||Geom. mean of fold change over Placebo|1.22||||0.2499|TWO_SIDED|90.0|0.91|1.62||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale||||1.62|0.91|0.2499
71674492|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8038|TWO_SIDED|90.0|-0.25|0.79|||MMRM|||Week 1: Mixed-effect model with repeated measures (MMRM) analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.79|-0.25|0.8038
71798311|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.109||0.3223|TWO_SIDED|95.0|-0.11|0.32|||MMRM|||Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.32|-0.11|0.3223
71798312|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.089||0.3385|TWO_SIDED|95.0|-0.26|0.09|||MMRM|||Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.09|-0.26|0.3385
71798313|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.1||0.7003|TWO_SIDED|95.0|-0.16|0.24|||MMRM|||Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.24|-0.16|0.7003
71798314|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.099||0.0311|TWO_SIDED|95.0|-0.41|-0.02|||MMRM|||Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||-0.02|-0.41|0.0311
71798315|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1976|TWO_SIDED|95.0|-0.26|0.06|||MMRM|||Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.06|-0.26|0.1976
71798316|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.092||0.5489|TWO_SIDED|95.0|-0.24|0.13|||MMRM|||Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.24|0.5489
71798317|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.075||0.7992|TWO_SIDED|95.0|-0.17|0.13|||MMRM|||Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects||0.13|-0.17|0.7992
71798318|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.103||0.0573|TWO_SIDED|95.0|-0.4|0.01|||MMRM|||Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.40|0.0573
71798319|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0431|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0431
71798320|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.108||0.006|TWO_SIDED|95.0|-0.52|-0.09|||MMRM|||Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.52|0.0060
71798321|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.127||0.0215|TWO_SIDED|95.0|-0.55|-0.04|||MMRM|||Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.55|0.0215
71798322|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.109||0.0422|TWO_SIDED|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.44|0.0422
71674493|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.8267|TWO_SIDED|90.0|-0.22|0.81|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.81|-0.22|0.8267
71840754|NCT01922050|143190823|SUPERIORITY||Ratio of clearance rates|2.55||||0.031|TWO_SIDED|95.0|1.09|5.98|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||5.98|1.09|0.031
71840755|NCT01922050|143190823|SUPERIORITY||Ratio of clearance rates|1.43||||0.29|TWO_SIDED|95.0|0.74|2.75|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.75|0.74|0.29
71840756|NCT01922050|143190824|SUPERIORITY||Ratio of clearance rates|1.69||||0.026|TWO_SIDED|95.0|1.06|2.69|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.69|1.06|0.026
71840757|NCT01922050|143190824|SUPERIORITY||Ratio of clearance rates|1.79||||0.013|TWO_SIDED|95.0|1.13|2.84|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||2.84|1.13|0.013
71840758|NCT01922050|143190824|SUPERIORITY||Ratio of clearance rates|2.1|||<|0.001|TWO_SIDED|95.0|1.35|3.25|||Log binomial regression|||||3.25|1.35|<0.001
71840759|NCT01922050|143190824|SUPERIORITY||Ratio of clearance rates|1.06||||0.73|TWO_SIDED|95.0|0.76|1.47|||Log binomial regression|||||1.47|0.76|0.73
71840760|NCT01922050|143190824|SUPERIORITY||Ratio of clearance rates|1.24||||0.16|TWO_SIDED|95.0|0.92|1.67|||Log binomial regression|||||1.67|0.92|0.16
71840761|NCT01922050|143190824|SUPERIORITY||Ratio of clearance rates|1.17||||0.3|TWO_SIDED|95.0|0.87|1.57|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.||1.57|0.87|0.30
71840762|NCT04642820|143190831|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||.05
71840763|NCT04568434|143190832|SUPERIORITY||LS mean difference|-43.5|||=|0.0009|TWO_SIDED|95.0|-69.085|-17.921||ANCOVA model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-17.921|-69.085|=0.0009
71840764|NCT04568434|143190832|SUPERIORITY||Least squares (LS) mean difference|-22.37|||=|0.0775|TWO_SIDED|95.0|-47.2|2.463||Analysis of covariance (ANCOVA) model included effects of treatment (olezarsen 80 mg, olezarsen 50 mg, or placebo): dependent variable, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||2.463|-47.200|=0.0775
71840765|NCT04568434|143190833|SUPERIORITY||LS mean difference|-43.81|||=|0.0044|TWO_SIDED|95.0|-73.928|-13.692||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-13.692|-73.928|=0.0044
71840766|NCT04568434|143190833|SUPERIORITY||LS mean difference|-59.39|||=|0.0002|TWO_SIDED|95.0|-90.663|-28.119||ANCOVA model included percent change from baseline in fasting TG at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline TG: covariate.|ANCOVA|||||-28.119|-90.663|=0.0002
71840767|NCT04568434|143190834|SUPERIORITY||LS mean difference|-65.48|||<|0.0001|TWO_SIDED|95.0|-82.634|-48.32||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-48.320|-82.634|<0.0001
71840768|NCT04568434|143190834|SUPERIORITY||LS mean difference|-73.69|||<|0.0001|TWO_SIDED|95.0|-94.553|-52.837||ANCOVA model included percent change from baseline in fasting apoC-III at Month 6: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 6||-52.837|-94.553|<0.0001
71840769|NCT04568434|143190834|SUPERIORITY||Ls mean difference|-77.06|||<|0.0001|TWO_SIDED|95.0|-98.938|-55.177||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-55.177|-98.938|<0.0001
71840770|NCT04568434|143190834|SUPERIORITY||LS mean difference|-81.28|||<|0.0001|TWO_SIDED|95.0|-104.656|-57.894||ANCOVA model included percent change from baseline in fasting apoC-III at Month 12: dependent variable, treatment group, protocol specified 2 randomization stratification factors: fixed effects, log-transformed baseline apoC-III: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-57.894|-104.656|<0.0001
71840771|NCT04568434|143190836|SUPERIORITY||LS mean difference|-33.29|||=|0.186|TWO_SIDED|95.0|-82.612|16.041||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||16.041|-82.612|=0.1860
71840772|NCT04568434|143190836|SUPERIORITY||LS mean difference|-83.97|||=|0.0019|TWO_SIDED|95.0|-136.949|-30.982||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change From Baseline at Month 6||-30.982|-136.949|=0.0019
71798323|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.126||0.0433|TWO_SIDED|95.0|-0.51|-0.01|||MMRM|||Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.51|0.0433
71798324|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.118||0.0051|TWO_SIDED|95.0|-0.57|-0.1|||MMRM|||Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.57|0.0051
71798325|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.133||0.0973|TWO_SIDED|95.0|-0.48|0.04|||MMRM|||Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.48|0.0973
71798326|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.126||0.0036|TWO_SIDED|95.0|-0.63|-0.13|||MMRM|||Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.63|0.0036
71798327|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.131||0.0498|TWO_SIDED|95.0|-0.52|0.0|||MMRM|||Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.52|0.0498
71798328|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5111|TWO_SIDED|95.0|-0.39|0.2|||MMRM|||Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.39|0.5111
71798329|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.155||0.5839|TWO_SIDED|95.0|-0.39|0.22|||MMRM|||Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.39|0.5839
71798330|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.1905|TWO_SIDED|95.0|-0.33|0.07|||MMRM|||Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.33|0.1905
71798331|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.162||0.1767|TWO_SIDED|95.0|-0.54|0.1|||MMRM|||Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.54|0.1767
71798332|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5182|TWO_SIDED|95.0|-0.47|0.24|||MMRM|||Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.47|0.5182
71798333|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.185||0.393|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3930
71798334|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.189||0.5212|TWO_SIDED|95.0|-0.5|0.25|||MMRM|||Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.50|0.5212
71840773|NCT04568434|143190836|SUPERIORITY||LS mean difference|-32.9|||=|0.4219|TWO_SIDED|95.0|-113.254|47.459||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||47.459|-113.254|=0.4219
71798335|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.184||0.4741|TWO_SIDED|95.0|-0.5|0.23|||MMRM|||Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.50|0.4741
71798336|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.186||0.4482|TWO_SIDED|95.0|-0.51|0.23|||MMRM|||Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.51|0.4482
71798337|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.187||0.0963|TWO_SIDED|95.0|-0.69|0.06|||MMRM|||Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.69|0.0963
71798338|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.171||0.003|TWO_SIDED|95.0|-0.86|-0.18|||MMRM|||Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.18|-0.86|0.0030
71798339|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.177||0.1116|TWO_SIDED|95.0|-0.63|0.07|||MMRM|||Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.63|0.1116
71798340|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.173||0.004|TWO_SIDED|95.0|-0.86|-0.17|||MMRM|||Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-0.86|0.0040
71798341|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.244||0.8253|TWO_SIDED|95.0|-0.54|0.43|||MMRM|||Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.54|0.8253
71798342|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.209||0.5795|TWO_SIDED|95.0|-0.3|0.53|||MMRM|||Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.53|-0.30|0.5795
71798343|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.182||0.4032|TWO_SIDED|95.0|-0.21|0.51|||MMRM|||Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|-0.21|0.4032
71798344|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.133||0.6117|TWO_SIDED|95.0|-0.33|0.2|||MMRM|||Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.33|0.6117
71798345|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4716|TWO_SIDED|95.0|-0.35|0.16|||MMRM|||Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.35|0.4716
71840774|NCT04568434|143190836|SUPERIORITY||LS mean difference|-75.63|||=|0.056|TWO_SIDED|95.0|-153.195|1.927||ANCOVA model included percent change from baseline in fasting apoB-48 to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline apoB-48: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||1.927|-153.195|=0.0560
71840775|NCT04568434|143190837|SUPERIORITY||LS mean difference|-17.69|||=|0.0401|TWO_SIDED|95.0|-34.571|-0.801||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline Month 6||-0.801|-34.571|=0.0401
71840776|NCT04568434|143190837|SUPERIORITY||LS mean difference|-24.2|||=|0.0036|TWO_SIDED|95.0|-40.484|-7.911||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 6: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate|ANCOVA|||Percent Change from Baseline Month 6||-7.911|-40.484|=0.0036
71840777|NCT04568434|143190837|SUPERIORITY||LS mean difference|-29.84|||=|0.0134|TWO_SIDED|95.0|-53.49|-6.198||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-6.198|-53.490|=0.0134
71840778|NCT04568434|143190837|SUPERIORITY||LS mean difference|-39.7|||=|0.0009|TWO_SIDED|95.0|-63.108|-16.292||ANCOVA model included percent change from baseline in fasting non-HDL-C to Month 12: dependent variable, treatment group, protocol prespecified randomization stratification factors: fixed effects \& log-transformed baseline non-HDL-C: covariate.|ANCOVA|||Percent Change from Baseline at Month 12||-16.292|-63.108|=0.0009
71840779|NCT04568434|143190838|SUPERIORITY||Mean Rate Ratio|0.1|||=|0.0052|TWO_SIDED|95.0|0.02|0.506||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.506|0.020|=0.0052
71840780|NCT04568434|143190839|SUPERIORITY||Mean Rate Ratio|0.12|||=|0.0144|TWO_SIDED|95.0|0.022|0.656||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable.|Negative Binomial Regression Model|||||0.656|0.022|=0.0144
71840781|NCT04568434|143190840|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0174|TWO_SIDED|95.0|0.028|0.709||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.709|0.028|=0.0174
71840782|NCT04568434|143190841|SUPERIORITY||Mean Rate Ratio|0.16|||=|0.0314|TWO_SIDED|95.0|0.031|0.85||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.850|0.031|=0.0314
71840783|NCT04568434|143190844|SUPERIORITY||Mean Rate Ratio|0.14|||=|0.0137|TWO_SIDED|95.0|0.029|0.669||Regression model: treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 1 to 53:offset variable|Negative Binomial Regression Model|||||0.669|0.029|=0.0137
71840784|NCT04568434|143190845|SUPERIORITY||Mean Rate Ratio|0.2|||=|0.048|TWO_SIDED|95.0|0.04|0.986||Regression model:treatment group \& previous treatment (volanesorsen):factors adjudicated acute pancreatitis events in 5 years prior enrollment:covariate. Logarithm of time in year that each participant was observed from Week 13 to 53:offset variable|Negative Binomial Regression Model|||||0.986|0.040|=0.0480
71840785|NCT05469464|143190847|SUPERIORITY||Mean Difference (Net)|-4.6|STANDARD_ERROR_OF_MEAN|6.93||0.505|TWO_SIDED|95.0|-18.2|9.0|||ANCOVA|||||9.0|-18.2|0.505
71840786|NCT05469464|143190847|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|7.15||0.812|TWO_SIDED|95.0|-15.8|12.3|||ANCOVA|||||12.3|-15.8|0.812
71840787|NCT05469464|143190847|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|6.99||0.118|TWO_SIDED|95.0|-24.6|2.8|||ANCOVA|||||2.8|-24.6|0.118
71840788|NCT06473662|143190896|OTHER||Mean Difference (Final Values)|-0.53||||0.0039|TWO_SIDED||||||t-test, 2 sided|||||||0.0039
71840789|NCT06473662|143190897|OTHER||Mean Difference (Final Values)|-18.8||||0.0166|TWO_SIDED||||||t-test, 2 sided|||||||0.0166
71840790|NCT06473662|143190899|OTHER||Mean Difference (Final Values)|-22.13||||0.0474|TWO_SIDED||||||ANCOVA|||||||0.0474
71840791|NCT05485779|143190910|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.17||||0.6358|TWO_SIDED|95.0|1.07|1.27|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 30.4. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.27|1.07|0.6358
71840792|NCT05485779|143190910|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.5506|TWO_SIDED|95.0|0.963|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 32.9. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|0.963|0.5506
71840793|NCT05485779|143190911|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.13||||0.3653|TWO_SIDED|95.0|1.04|1.22|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 25.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.22|1.04|0.3653
71840794|NCT05485779|143190911|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.2933|TWO_SIDED|95.0|1.01|1.31|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 27.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.31|1.01|0.2933
71840795|NCT05485779|143190912|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.16||||0.46|TWO_SIDED|95.0|0.908|1.41|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 64.3. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.41|0.908|0.4600
71840796|NCT05485779|143190912|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12||||0.3157|TWO_SIDED|95.0|0.795|1.45|||Lack of Fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 65.6. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.45|0.795|0.3157
71840797|NCT05485779|143190913|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.2||||0.235|TWO_SIDED|95.0|1.02|1.37|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 54.2. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 3 to 60 mg AQ280||1.37|1.02|0.2350
71840798|NCT05485779|143190913|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.19||||0.1632|TWO_SIDED|95.0|0.88|1.5|||Lack of fit 1-sided p-value|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 58.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Single Oral Doses of 9 to 60 mg AQ280||1.50|0.880|0.1632
71840799|NCT05485779|143190914|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.977|||||TWO_SIDED|90.0|0.915|1.04|||||Within-subject geometric coefficient of variation was 5.66. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.04|0.915|
71840800|NCT05485779|143190915|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.805|||||TWO_SIDED|90.0|0.635|1.02|||||Within-subject geometric coefficient of variation was 20.5. Data analyzed using a mixed model included treatment as a fixed effect and subject as a random effect. ln(parameter)=treatment+subject+random error, with subject fitted as a random effect.|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess the Effect of Food on Single Oral Doses of 16 mg AQ280||1.02|0.635|
71840801|NCT05485779|143190917|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.15||||0.1558|TWO_SIDED|95.0|0.954|1.34|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 28.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.34|0.954|0.1558
71674494|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6039|TWO_SIDED|90.0|-0.43|0.6|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.60|-0.43|0.6039
71840802|NCT05485779|143190918|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1||||0.5458|TWO_SIDED|95.0|0.946|1.26|||Lack of Fit 2-sided model|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 24.0. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error|Statistical Analysis of AQ280 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 QD for 7 Consecutive Days in a Fasted State||1.26|0.946|0.5458
71674495|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.6339|TWO_SIDED|90.0|-0.41|0.62|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-0.41|0.6339
71840803|NCT05485779|143190919|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.941||||0.4856|TWO_SIDED|95.0|0.602|1.28||Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Lack of fit 2-sided||Between-subject geometric coefficient of variation was 54.7. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.602|0.4856
71674496|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.2666|TWO_SIDED|90.0|-0.68|0.31|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.31|-0.68|0.2666
71674497|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.2257|TWO_SIDED|90.0|-0.7|0.26|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-0.70|0.2257
71674498|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.1306|TWO_SIDED|90.0|-0.81|0.15|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-0.81|0.1306
71674499|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.37||0.9704|TWO_SIDED|90.0|0.09|1.31|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.31|0.09|0.9704
71674500|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.38||0.889|TWO_SIDED|90.0|-0.16|1.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.09|-0.16|0.8890
71674501|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.4506|TWO_SIDED|90.0|-0.66|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.66|0.4506
71798346|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.136||0.6041|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.6041
71798347|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.132||0.0424|TWO_SIDED|95.0|-0.53|-0.01|||MMRM|||Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.53|0.0424
71798348|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.138||0.7622|TWO_SIDED|95.0|-0.32|0.23|||MMRM|||Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.32|0.7622
71798349|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2689|TWO_SIDED|95.0|-0.4|0.11|||MMRM|||Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.40|0.2689
71798350|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.134||0.211|TWO_SIDED|95.0|-0.44|0.1|||MMRM|||Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.44|0.2110
71798351|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.135||0.5873|TWO_SIDED|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.34|0.5873
71798352|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.114||0.045|TWO_SIDED|95.0|-0.46|-0.01|||MMRM|||Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.46|0.0450
71798353|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.152||0.0847|TWO_SIDED|95.0|-0.57|0.04|||MMRM|||Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.57|0.0847
71798354|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.189||0.2522|TWO_SIDED|95.0|-0.16|0.6|||MMRM|||Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.60|-0.16|0.2522
71674502|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.584|TWO_SIDED|90.0|-0.53|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.53|0.5840
71674503|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.0769|TWO_SIDED|90.0|-1.17|0.08|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.17|0.0769
71674504|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.38||0.0242|TWO_SIDED|90.0|-1.39|-0.13|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-1.39|0.0242
71674505|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.38||0.0127|TWO_SIDED|90.0|-1.49|-0.23|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.23|-1.49|0.0127
71674506|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.44||0.6693|TWO_SIDED|90.0|-0.54|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-0.54|0.6693
71798355|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.5026|TWO_SIDED|95.0|-0.43|0.21|||MMRM|||Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.43|0.5026
71798356|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.149||0.5911|TWO_SIDED|95.0|-0.38|0.22|||MMRM|||Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.38|0.5911
71798357|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.122||0.58|TWO_SIDED|95.0|-0.18|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.18|0.5800
71798358|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.129||0.6754|TWO_SIDED|95.0|-0.31|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.31|0.6754
71798359|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.116||0.1006|TWO_SIDED|95.0|-0.04|0.42|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.04|0.1006
71798360|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.12||0.3588|TWO_SIDED|95.0|-0.13|0.35|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.13|0.3588
71840804|NCT05485779|143190920|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971||||0.1455|TWO_SIDED|95.0|0.666|1.28|||Lack of fit 2-sided|Lack of Fit Model: ln(parameter) = intercept + slope × ln(dose) + dose + random error|Between-subject geometric coefficient of variation was 45.5. Data were analyzed using a power model. ln(parameter) = intercept + slope ×ln(dose) + random error.|Statistical Analysis of Metabolite AQ282 Primary Pharmacokinetic Endpoints to Assess Dose Proportionality of Multiple Oral Doses of 9 to 60 mg AQ280 once daily for 7 Consecutive Days in a Fasted State||1.28|0.666|0.1455
71840805|NCT01712490|143190949|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.035|TWO_SIDED|95.0|0.603|0.983|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (\<) 1 favors A+AVD arm.||0.983|0.603|0.035
71840806|NCT01712490|143190950|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.199|TWO_SIDED|95.0|0.448|1.184|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox's proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio \<1 favors A+AVD arm.||1.184|0.448|0.199
71840807|NCT03987022|143190968|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||.16
71840808|NCT03987022|143190969|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71674507|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6742|TWO_SIDED|90.0|-0.55|0.96|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.96|-0.55|0.6742
71674508|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4486|TWO_SIDED|90.0|-0.79|0.67|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.79|0.4486
71674509|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3219|TWO_SIDED|90.0|-0.93|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.93|0.3219
71674510|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.55||0.0096|TWO_SIDED|90.0|-2.21|-0.39|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.39|-2.21|0.0096
71674511|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.0862|TWO_SIDED|90.0|-1.64|0.15|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.64|0.0862
71674512|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54||0.0111|TWO_SIDED|90.0|-2.15|-0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.36|-2.15|0.0111
71674513|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.5||0.6107|TWO_SIDED|90.0|-0.68|0.97|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.97|-0.68|0.6107
71674514|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.51||0.724|TWO_SIDED|90.0|-0.54|1.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.15|-0.54|0.7240
71798361|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.109||0.5807|TWO_SIDED|95.0|-0.28|0.16|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.28|0.5807
71674515|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.43|TWO_SIDED|90.0|-0.91|0.74|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.91|0.4300
71674516|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.0501|TWO_SIDED|90.0|-1.66|0.0|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.66|0.0501
71674517|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58||0.0157|TWO_SIDED|90.0|-2.23|-0.3|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.30|-2.23|0.0157
71674518|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0645|TWO_SIDED|90.0|-1.83|0.07|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.83|0.0645
71674519|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.57||0.0621|TWO_SIDED|90.0|-1.84|0.06|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.06|-1.84|0.0621
71674520|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.2959|TWO_SIDED|90.0|-1.21|0.62|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.62|-1.21|0.2959
71674521|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.57||0.9043|TWO_SIDED|90.0|-0.19|1.69|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.69|-0.19|0.9043
71798362|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.112||0.4241|TWO_SIDED|95.0|-0.13|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.13|0.4241
71840809|NCT03987022|143190970|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||.01
71840810|NCT03987022|143190971|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71840811|NCT03987022|143190972|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||.58
71840812|NCT03987022|143190973|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||.47
71840813|NCT03987022|143190974|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71674522|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.55||0.2014|TWO_SIDED|90.0|-1.38|0.45|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.45|-1.38|0.2014
71674523|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.0948|TWO_SIDED|90.0|-1.66|0.19|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.19|-1.66|0.0948
71674524|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.65||0.0416|TWO_SIDED|90.0|-2.21|-0.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.06|-2.21|0.0416
71674525|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.64||0.0454|TWO_SIDED|90.0|-2.14|-0.03|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.03|-2.14|0.0454
71674526|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.64||0.0256|TWO_SIDED|90.0|-2.31|-0.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.20|-2.31|0.0256
71674527|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.57||0.2326|TWO_SIDED|90.0|-1.36|0.53|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.36|0.2326
71674528|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.5141|TWO_SIDED|90.0|-0.95|0.99|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.99|-0.95|0.5141
71798363|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.115||0.7984|TWO_SIDED|95.0|-0.26|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.26|0.7984
71798364|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.122||0.8732|TWO_SIDED|95.0|-0.22|0.26|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.22|0.8732
71798365|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.107||0.8621|TWO_SIDED|95.0|-0.19|0.23|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.19|0.8621
71798366|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.126||0.1087|TWO_SIDED|95.0|-0.45|0.05|||MMRM|||Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.45|0.1087
71798367|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.125||0.2153|TWO_SIDED|95.0|-0.41|0.09|||MMRM|||Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.41|0.2153
71674529|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57||0.1124|TWO_SIDED|90.0|-1.64|0.25|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.25|-1.64|0.1124
71798368|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.145||0.1422|TWO_SIDED|95.0|-0.51|0.07|||MMRM|||Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.51|0.1422
71798369|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.114||0.7211|TWO_SIDED|95.0|-0.19|0.27|||MMRM|||Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.19|0.7211
71840814|NCT03987022|143190975|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
71674530|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.0983|TWO_SIDED|90.0|-1.7|0.21|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.70|0.0983
71674531|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.72||0.0412|TWO_SIDED|90.0|-2.46|-0.07|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.07|-2.46|0.0412
71674532|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.034|TWO_SIDED|90.0|-2.47|-0.13|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.13|-2.47|0.0340
71798370|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8224|TWO_SIDED|95.0|-0.18|0.23|||MMRM|||Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.18|0.8224
71798371|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6362|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6362
71840815|NCT03987022|143190976|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71840816|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-178.789|||<|0.0001|TWO_SIDED|95.0|-204.899|-152.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-152.678|-204.899|<.0001
71840817|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-184.391|||<|0.0001|TWO_SIDED|95.0|-211.184|-157.598|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-157.598|-211.184|<.0001
71840818|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.1|||<|0.0001|TWO_SIDED|95.0|-200.964|-149.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-149.237|-200.964|<.0001
71893407|NCT03577990|143307834|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|1250.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
71798372|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6094|TWO_SIDED|95.0|-0.31|0.18|||MMRM|||Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.31|0.6094
71674533|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.71||0.0379|TWO_SIDED|90.0|-2.44|-0.09|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.44|0.0379
71798373|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.123||0.0457|TWO_SIDED|95.0|-0.49|0.0|||MMRM|||Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.49|0.0457
71798374|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5691|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5691
71798375|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2942|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2942
71798376|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.136||0.5389|TWO_SIDED|95.0|-0.35|0.19|||MMRM|||Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.35|0.5389
71798377|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4061|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4061
71798378|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.153||0.099|TWO_SIDED|95.0|-0.56|0.05|||MMRM|||Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.56|0.0990
71798379|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.138||0.0108|TWO_SIDED|95.0|-0.63|-0.08|||MMRM|||Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.63|0.0108
71798380|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.16||0.0889|TWO_SIDED|95.0|-0.59|0.04|||MMRM|||Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.59|0.0889
71798381|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.169||0.3721|TWO_SIDED|95.0|-0.18|0.49|||MMRM|||Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.18|0.3721
71798382|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.141||0.5513|TWO_SIDED|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.36|0.5513
71798383|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0748|TWO_SIDED|95.0|-0.01|0.26|||MMRM|||Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.01|0.0748
71798384|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.087||0.3545|TWO_SIDED|95.0|-0.09|0.25|||MMRM|||Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.09|0.3545
71674534|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.68||0.1291|TWO_SIDED|90.0|-1.91|0.36|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.36|-1.91|0.1291
71798385|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.094||0.6531|TWO_SIDED|95.0|-0.14|0.23|||MMRM|||Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.14|0.6531
71798386|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.115||0.752|TWO_SIDED|95.0|-0.26|0.19|||MMRM|||Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.26|0.7520
71798387|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.123||0.8861|TWO_SIDED|95.0|-0.26|0.23|||MMRM|||Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.26|0.8861
71798388|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.127||0.328|TWO_SIDED|95.0|-0.38|0.13|||MMRM|||Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.38|0.3280
71798389|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.128||0.1123|TWO_SIDED|95.0|-0.46|0.05|||MMRM|||Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.46|0.1123
71798390|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.116||0.2541|TWO_SIDED|95.0|-0.36|0.1|||MMRM|||Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.36|0.2541
71798391|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.143||0.011|TWO_SIDED|95.0|-0.66|-0.09|||MMRM|||Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.66|0.0110
71798392|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.158||0.772|TWO_SIDED|95.0|-0.36|0.27|||MMRM|||Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.36|0.7720
71798393|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6311|TWO_SIDED|95.0|-0.52|0.32|||MMRM|||Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.52|0.6311
71798394|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.207||0.6877|TWO_SIDED|95.0|-0.5|0.33|||MMRM|||Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.50|0.6877
71840819|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-161.576|||<|0.0001|TWO_SIDED|95.0|-187.543|-135.609|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-135.609|-187.543|<.0001
71674535|NCT03850483|142867378|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.7||0.5776|TWO_SIDED|90.0|-1.03|1.3|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.30|-1.03|0.5776
71674536|NCT03850483|142867378|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1044|TWO_SIDED|90.0|-2.0|0.27|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.27|-2.00|0.1044
71674537|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.0608|TWO_SIDED|90.0|-2.23|0.07|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-2.23|0.0608
71674538|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0309|TWO_SIDED|90.0|-2.84|-0.18|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.18|-2.84|0.0309
71674539|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.78||0.0242|TWO_SIDED|90.0|-2.85|-0.26|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.26|-2.85|0.0242
71674540|NCT03850483|142867378|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.78||0.0394|TWO_SIDED|90.0|-2.69|-0.09|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.09|-2.69|0.0394
71674541|NCT03850483|142867380|SUPERIORITY||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|5.09||0.6917|TWO_SIDED|90.0|-5.86|10.97|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.97|-5.86|0.6917
71840820|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-172.983|||<|0.0001|TWO_SIDED|95.0|-192.08|-153.886|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-153.886|-192.080|<.0001
71674542|NCT03850483|142867380|SUPERIORITY||LS mean difference|7.3|STANDARD_ERROR_OF_MEAN|5.07||0.9241|TWO_SIDED|90.0|-1.09|15.69|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.69|-1.09|0.9241
71798395|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.186||0.2465|TWO_SIDED|95.0|-0.15|0.58|||MMRM|||Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.15|0.2465
71798396|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.101||0.1279|TWO_SIDED|95.0|-0.36|0.05|||MMRM|||Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.36|0.1279
71896273|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|5.562||||0.001|TWO_SIDED|95.0|1.932|16.013||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||16.013|1.932|0.001
71674543|NCT03850483|142867380|SUPERIORITY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|5.03||0.8443|TWO_SIDED|90.0|-3.21|13.42|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.42|-3.21|0.8443
71674544|NCT03850483|142867380|SUPERIORITY||LS mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.04||0.6911|TWO_SIDED|90.0|-5.82|10.86|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||10.86|-5.82|0.6911
71674545|NCT03850483|142867380|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|4.79||0.3676|TWO_SIDED|90.0|-9.56|6.31|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.31|-9.56|0.3676
71674546|NCT03850483|142867380|SUPERIORITY||LS mean difference|-6.3|STANDARD_ERROR_OF_MEAN|4.72||0.0915|TWO_SIDED|90.0|-14.13|1.5|||MMRM|||Week 1: Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.50|-14.13|0.0915
71674547|NCT03850483|142867380|SUPERIORITY||LS mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.72||0.097|TWO_SIDED|90.0|-13.96|1.65|||MMRM|||Week 1: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.65|-13.96|0.0970
71840821|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-3.585||||0.7781|TWO_SIDED|95.0|-28.572|21.401|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||21.401|-28.572|0.7781
71840822|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-7.764||||0.5457|TWO_SIDED|95.0|-32.993|17.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||17.465|-32.993|0.5457
71840823|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-175.203|||<|0.0001|TWO_SIDED|95.0|-220.445|-129.961|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-129.961|-220.445|<.0001
71840824|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-176.627|||<|0.0001|TWO_SIDED|95.0|-222.672|-130.582|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-130.582|-222.672|<.0001
71840825|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-171.515|||<|0.0001|TWO_SIDED|95.0|-216.626|-126.404|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-126.404|-216.626|<.0001
71840826|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.812|||<|0.0001|TWO_SIDED|95.0|-199.27|-108.354|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-108.354|-199.270|<.0001
71893408|NCT03577990|143307835|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|300.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
71674548|NCT03850483|142867380|SUPERIORITY||LS mean difference|9.2|STANDARD_ERROR_OF_MEAN|5.91||0.9389|TWO_SIDED|90.0|-0.59|18.97|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||18.97|-0.59|0.9389
71674549|NCT03850483|142867380|SUPERIORITY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|6.07||0.9295|TWO_SIDED|90.0|-1.06|19.02|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors||19.02|-1.06|0.9295
71798397|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.093||0.3946|TWO_SIDED|95.0|-0.26|0.1|||MMRM|||Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.26|0.3946
71798398|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.095||0.6694|TWO_SIDED|95.0|-0.23|0.15|||MMRM|||Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.23|0.6694
71798399|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.1113|TWO_SIDED|95.0|-0.36|0.04|||MMRM|||Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.36|0.1113
71674550|NCT03850483|142867380|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|5.92||0.7308|TWO_SIDED|90.0|-6.15|13.45|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||13.45|-6.15|0.7308
71798400|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.5811|TWO_SIDED|95.0|-0.13|0.23|||MMRM|||Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.13|0.5811
71798401|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.106||0.6794|TWO_SIDED|95.0|-0.25|0.17|||MMRM|||Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.25|0.6794
71798402|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.099||0.6031|TWO_SIDED|95.0|-0.14|0.25|||MMRM|||Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.14|0.6031
71798403|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.099||0.6673|TWO_SIDED|95.0|-0.24|0.15|||MMRM|||Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.24|0.6673
71798404|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.102||0.6472|TWO_SIDED|95.0|-0.25|0.16|||MMRM|||Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.25|0.6472
71798405|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.119||0.8654|TWO_SIDED|95.0|-0.26|0.22|||MMRM|||Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.26|0.8654
71896274|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|2.979||||0.05|TWO_SIDED|95.0|0.999|8.882||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.882|0.999|0.050
71674551|NCT03850483|142867380|SUPERIORITY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|5.94||0.6199|TWO_SIDED|90.0|-8.01|11.64|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||11.64|-8.01|0.6199
71674552|NCT03850483|142867380|SUPERIORITY||LS mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.09||0.0699|TWO_SIDED|90.0|-19.13|1.04|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.04|-19.13|0.0699
71798406|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2101|TWO_SIDED|95.0|-0.48|0.11|||MMRM|||Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.48|0.2101
71798407|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.126||0.7128|TWO_SIDED|95.0|-0.3|0.21|||MMRM|||Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.30|0.7128
71798408|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.09||0.3297|TWO_SIDED|95.0|-0.27|0.09|||MMRM|||Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.27|0.3297
71798409|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.069||0.4493|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.08|0.4493
71798410|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.081||0.0717|TWO_SIDED|95.0|-0.01|0.31|||MMRM|||Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.01|0.0717
71798411|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.066||0.1054|TWO_SIDED|95.0|-0.02|0.24|||MMRM|||Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.02|0.1054
71798412|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.088||0.0408|TWO_SIDED|95.0|0.01|0.36|||MMRM|||Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|0.01|0.0408
71798413|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.088||0.0233|TWO_SIDED|95.0|0.03|0.38|||MMRM|||Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|0.03|0.0233
71798414|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.088||0.361|TWO_SIDED|95.0|-0.09|0.26|||MMRM|||Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.09|0.3610
71798415|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2358|TWO_SIDED|95.0|-0.08|0.32|||MMRM|||Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.08|0.2358
71798416|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.085||0.9492|TWO_SIDED|95.0|-0.16|0.17|||MMRM|||Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.16|0.9492
71798417|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.102||0.4352|TWO_SIDED|95.0|-0.28|0.12|||MMRM|||Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.28|0.4352
71798418|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.125||0.1176|TWO_SIDED|95.0|-0.05|0.44|||MMRM|||Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.05|0.1176
71798419|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.174||0.7812|TWO_SIDED|95.0|-0.3|0.4|||MMRM|||Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.30|0.7812
71798420|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.182||0.5085|TWO_SIDED|95.0|-0.48|0.24|||MMRM|||Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.48|0.5085
71798421|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.156||0.8274|TWO_SIDED|95.0|-0.28|0.34|||MMRM|||Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.28|0.8274
71798422|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3675|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3675
71798423|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1818|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1818
71798424|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.045||0.0826|TWO_SIDED|95.0|-0.17|0.01|||MMRM|||Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.17|0.0826
71798425|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6436|TWO_SIDED|95.0|-0.11|0.07|||MMRM|||Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.11|0.6436
71798426|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.1827|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.15|0.1827
71798427|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.045||0.9859|TWO_SIDED|95.0|-0.09|0.09|||MMRM|||Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.09|0.9859
71896275|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|4.418||||0.006|TWO_SIDED|95.0|1.521|12.834||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.834|1.521|0.006
71896276|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|4.165||||0.009|TWO_SIDED|95.0|1.425|12.178||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||12.178|1.425|0.009
71798428|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6672|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6672
71840827|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-165.22|||<|0.0001|TWO_SIDED|95.0|-195.898|-134.541|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-134.541|-195.898|<.0001
71840828|NCT04800211|143190995|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.815||||0.2188|TWO_SIDED|95.0|-59.223|13.593|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||13.593|-59.223|0.2188
71840829|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-248.311|||<|0.0001|TWO_SIDED|95.0|-286.423|-210.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-210.199|-286.423|<.0001
71674553|NCT03850483|142867380|SUPERIORITY||LS mean difference|-11.6|STANDARD_ERROR_OF_MEAN|6.14||0.03|TWO_SIDED|90.0|-21.79|-1.48|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.48|-21.79|0.0300
71840830|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-247.572|||<|0.0001|TWO_SIDED|95.0|-280.904|-214.241|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-214.241|-280.904|<.0001
71840831|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-245.868|||<|0.0001|TWO_SIDED|95.0|-284.945|-206.791|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.791|-284.945|<.0001
71896277|NCT03114969|143314779|SUPERIORITY||Odds Ratio (OR)|1.209||||0.761|TWO_SIDED|95.0|0.357|4.095||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.095|0.357|0.761
71896278|NCT03114969|143314780|SUPERIORITY||Odds Ratio (OR)|2.292||||0.1|TWO_SIDED|95.0|0.853|6.163||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.163|0.853|0.100
71674554|NCT03850483|142867380|SUPERIORITY||LS mean difference|-13.1|STANDARD_ERROR_OF_MEAN|6.09||0.0168|TWO_SIDED|90.0|-23.15|-2.98|||MMRM|||Week 2: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.98|-23.15|0.0168
71798429|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.046||0.2031|TWO_SIDED|95.0|-0.03|0.15|||MMRM|||Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.03|0.2031
71798430|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.045||0.6664|TWO_SIDED|95.0|-0.07|0.11|||MMRM|||Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.07|0.6664
71798431|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.3417|TWO_SIDED|95.0|-0.13|0.05|||MMRM|||Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.13|0.3417
71798432|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.6622|TWO_SIDED|95.0|-0.12|0.08|||MMRM|||Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.12|0.6622
71798433|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.051||0.9087|TWO_SIDED|95.0|-0.11|0.09|||MMRM|||Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.11|0.9087
71798434|NCT02942017|143096501|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.8263|TWO_SIDED|95.0|-0.08|0.1|||MMRM|||Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.08|0.8263
71798435|NCT02942017|143096502|SUPERIORITY||LS mean difference|-4.86|STANDARD_ERROR_OF_MEAN|1.612||0.0033|TWO_SIDED|95.0|-8.06|-1.66|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.66|-8.06|0.0033
71798436|NCT02942017|143096502|SUPERIORITY||LS mean difference|-3.56|STANDARD_ERROR_OF_MEAN|2.154||0.1017|TWO_SIDED|95.0|-7.84|0.72|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.72|-7.84|0.1017
71798437|NCT02942017|143096502|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|1.884||0.9845|TWO_SIDED|95.0|-3.72|3.79|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.79|-3.72|0.9845
71896279|NCT03114969|143314780|SUPERIORITY||Odds Ratio (OR)|2.642||||0.051|TWO_SIDED|95.0|0.994|7.022||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.022|0.994|0.051
71798438|NCT02942017|143096503|SUPERIORITY||Odds Ratio (OR)|5.0||||0.0005|TWO_SIDED|95.0|2.0|12.5|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||12.5|2.0|0.0005
71798439|NCT02942017|143096503|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0478|TWO_SIDED|95.0|1.0|8.4|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||8.4|1.0|0.0478
71798440|NCT02942017|143096503|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4399|TWO_SIDED|95.0|0.5|4.6|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||4.6|0.5|0.4399
71798441|NCT02942017|143096504|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.041||0.2636|TWO_SIDED|95.0|-3.24|0.9|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.90|-3.24|0.2636
71896280|NCT03114969|143314781|SUPERIORITY||Odds Ratio (OR)|3.995|||<|0.001|TWO_SIDED|95.0|1.808|8.829||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.829|1.808|<0.001
71798442|NCT02942017|143096504|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|1.103||0.4897|TWO_SIDED|95.0|-2.96|1.43|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.43|-2.96|0.4897
71798443|NCT02942017|143096504|SUPERIORITY||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|1.227||0.1341|TWO_SIDED|95.0|-4.3|0.59|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-4.30|0.1341
71798444|NCT02942017|143096504|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.408||0.1691|TWO_SIDED|95.0|-4.76|0.85|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.85|-4.76|0.1691
71798445|NCT02942017|143096504|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|1.149||0.7852|TWO_SIDED|95.0|-2.6|1.97|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-2.60|0.7852
71798446|NCT02115282|143096507|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3|TWO_SIDED|95.0|0.67|1.13||The p value was based on stratified log rank test, the threshold for significance was two-sided p value of 0.2%.|Log Rank|||||1.13|0.67|0.30
71798447|NCT02115282|143096508|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.94|TWO_SIDED|95.0|0.82|1.21||The p value was based on stratified log rank test, stratified on the four randomization factors. The threshold for statistical significance was two-sided p value of 3.7% after taking into account the five interim analyses of OS into account.|Log Rank|||||1.21|0.82|0.94
71896281|NCT03114969|143314781|SUPERIORITY||Odds Ratio (OR)|2.181||||0.069|TWO_SIDED|95.0|0.94|5.059||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.059|0.940|0.069
71674555|NCT03850483|142867380|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|6.61||0.7083|TWO_SIDED|90.0|-7.3|14.57|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.57|-7.30|0.7083
71798448|NCT00457197|143096516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||ANCOVA|||Baseline drinks/day used as covariate.||||0.4709
71798449|NCT00457197|143096517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1272|TWO_SIDED||||||ANCOVA|||Baseline percent heavy drinking days included as covariate.||||0.1272
71798450|NCT00457197|143096518|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9642|TWO_SIDED||||||ANCOVA|||Baseline GGT used as covariate.||||0.9642
71798451|NCT00457197|143096519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7222|TWO_SIDED||||||ANCOVA|||Baseline AST used as covariate.||||0.7222
71798452|NCT00457197|143096520|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1412|TWO_SIDED||||||ANCOVA|||Baseline ALT used as covariate.||||0.1412
71798453|NCT00457197|143096521|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7071|TWO_SIDED||||||ANCOVA|||Baseline HRSD used as covariate.||||0.7071
71798454|NCT00457197|143096522|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2569|TWO_SIDED||||||ANCOVA|||Baseline IDS-SR used as a covariate.||||0.2569
71798455|NCT00457197|143096523|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8814|TWO_SIDED||||||ANCOVA|||Baseline YMRS used as a covariate.||||0.8814
71798456|NCT00457197|143096524|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2473|TWO_SIDED||||||ANCOVA|||Baseline PACS used as a covariate.||||0.2473
71798457|NCT04538664|143096530|SUPERIORITY||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.296|0.528|||Log Rank|||||0.528|0.296|<0.0001
71798458|NCT01723228|143096593|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.8||||0.2204|TWO_SIDED|95.0|-0.48|2.05|||repeated measures model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||2.05|-0.48|0.2204
71798459|NCT01723228|143096594|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.8428|TWO_SIDED|95.0|-0.99|0.81|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||0.81|-0.99|0.8428
71798460|NCT01723228|143096595|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7||||0.4796|TWO_SIDED|95.0|-2.74|1.3|||ANCOVA|The statistical model is an analysis of covariance (ANCOVA) with treatment, center, baseline score, and age as fixed effects.||||1.30|-2.74|0.4796
71798461|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.1148|TWO_SIDED|95.0|0.89|2.93|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC||2.93|0.89|0.1148
71798462|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1052|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the Cochran-Mantel-Haenszel (CMH) p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC||||0.1052
71798463|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.8857|TWO_SIDED|95.0|0.52|1.75|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Cognition||1.75|0.52|0.8857
71674556|NCT03850483|142867380|SUPERIORITY||LS mean difference|8.5|STANDARD_ERROR_OF_MEAN|6.77||0.8955|TWO_SIDED|90.0|-2.66|19.75|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.75|-2.66|0.8955
71674557|NCT03850483|142867380|SUPERIORITY||LS mean difference|6.5|STANDARD_ERROR_OF_MEAN|6.56||0.8386|TWO_SIDED|90.0|-4.35|17.37|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.37|-4.35|0.8386
71896282|NCT03114969|143314781|SUPERIORITY||Odds Ratio (OR)|4.855|||<|0.001|TWO_SIDED|95.0|2.339|10.08||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||10.080|2.339|<0.001
71674558|NCT03850483|142867380|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|6.58||0.4371|TWO_SIDED|90.0|-11.93|9.84|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.84|-11.93|0.4371
71674559|NCT03850483|142867380|SUPERIORITY||LS mean difference|-20.7|STANDARD_ERROR_OF_MEAN|8.91||0.0108|TWO_SIDED|90.0|-35.42|-5.92|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-5.92|-35.42|0.0108
71798464|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9945|TWO_SIDED|||||For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.|Cochran-Mantel-Haenszel|||CGIC Cognition||||0.9945
71798465|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.6909|TWO_SIDED|95.0|0.56|2.43|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Behavior||2.43|0.56|0.6909
71798466|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6639|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Behavior||||0.6639
71798467|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.3204|TWO_SIDED|95.0|0.72|2.68|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Functional Abilities||2.68|0.72|0.3204
71798468|NCT01723228|143096596|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331|TWO_SIDED||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Functional Abilities||||0.3331
71798469|NCT01723228|143096597|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.5||||0.0151|TWO_SIDED|95.0|-4.47|-0.49|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-0.49|-4.47|0.0151
71798470|NCT01723228|143096598|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.3||||0.0003|TWO_SIDED|95.0|-3.53|-1.08|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.||||-1.08|-3.53|0.0003
71798471|NCT00689481|143096633|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.016
71798472|NCT00689481|143096633|SUPERIORITY_OR_OTHER|||||||0.843|||||||Breslow-Day test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1||||0.843
71674560|NCT03850483|142867380|SUPERIORITY||LS mean difference|-10.9|STANDARD_ERROR_OF_MEAN|8.75||0.1066|TWO_SIDED|90.0|-25.43|3.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.55|-25.43|0.1066
71674561|NCT03850483|142867380|SUPERIORITY||LS mean difference|-16.0|STANDARD_ERROR_OF_MEAN|8.76||0.0344|TWO_SIDED|90.0|-30.54|-1.55|||MMRM|||Week 4: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.55|-30.54|0.0344
71674562|NCT03850483|142867380|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|8.29||0.6594|TWO_SIDED|90.0|-10.3|17.13|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||17.13|-10.30|0.6594
71674563|NCT03850483|142867380|SUPERIORITY||LS mean difference|5.3|STANDARD_ERROR_OF_MEAN|8.52||0.7307|TWO_SIDED|90.0|-8.85|19.36|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.36|-8.85|0.7307
71674564|NCT03850483|142867380|SUPERIORITY||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|8.28||0.5914|TWO_SIDED|90.0|-11.78|15.61|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||15.61|-11.78|0.5914
71798473|NCT00689481|143096634|SUPERIORITY_OR_OTHER|||||||0.034|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.034
71798474|NCT00689481|143096635|SUPERIORITY_OR_OTHER|||||||0.004||||||P-value is significant based on the Holm stepwise closed testing procedure to control multiplicity for the key secondary analyses if primary analysis was significant.|Cochran-Mantel-Haenszel|Stratified by pooled center.||||||0.004
71798475|NCT00689481|143096636|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.052
71798476|NCT00689481|143096637|SUPERIORITY_OR_OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.033
71798477|NCT00689481|143096638|SUPERIORITY_OR_OTHER|||||||0.859|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline||||0.859
71798478|NCT00689481|143096638|SUPERIORITY_OR_OTHER|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline||||0.015
71840832|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-234.942|||<|0.0001|TWO_SIDED|95.0|-271.603|-198.282|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-198.282|-271.603|<.0001
71840833|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-244.049|||<|0.0001|TWO_SIDED|95.0|-275.269|-212.829|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-212.829|-275.269|<.0001
71798479|NCT06425458|143096643|OTHER|||||||0.0011||||||Threshold for statistical significance: P \<= 0.05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Esteem (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0011
71840834|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-221.385|||<|0.0001|TWO_SIDED|95.0|-258.371|-184.398|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-184.398|-258.371|<.0001
71893409|NCT03577990|143307837|SUPERIORITY|Our sample (N = 90) had approximately 80% power (assuming 5 dropouts per arm) to detect an effect size of ∼.205 or greater at the α = .05 level of statistical significance, given a realistic range of simulated unstructured covariance matrices. An 11% rate of attrition was anticipated to yield a final sample of 80 participants, an average of 40 per arm. Participants who dropped out of the study prior to receiving the allotted intervention were not included in the analysis.|Mean Difference (Final Values)|500.0||||0.05|TWO_SIDED|||||P-values were computed according to a mixed-effects repeated measures model, appropriately constrained to baseline if indicated.|mixed-effects repeated measures||||For both referent (compared by month and treatment group) and constrained longitudinal data analysis (cLDA) models, p-values were computed for the main group (G), time (T), and interaction (G x T) effects. For the first 3 months of the referent arm (IT), data were compared with usual care. Consequently, months 1 - 6 in the statistical analysis corresponds to calendar months 4 - 9 of the data collection. Months 1 - 9 of the intervention arm (ITEC) reflects months 1 - 9 of the collection. Additionally, for the cLDA model, data in the referent arm (IT) were accordingly shifted such that the starting point on the y-axis for both arms were the same (i.e. y = 0).|||.05
71674565|NCT03850483|142867380|SUPERIORITY||LS mean difference|-12.3|STANDARD_ERROR_OF_MEAN|8.34||0.0709|TWO_SIDED|90.0|-26.13|1.49|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.49|-26.13|0.0709
71798480|NCT06425458|143096643|OTHER|||||||0.0719||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Purpose in Life (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.0719
71798481|NCT06425458|143096643|OTHER|||||||0.7991||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Locus of Control (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.7991
71798482|NCT06425458|143096643|OTHER|||||||0.2208||||||Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-tests were conducted to compare T1 and T2 Self-Efficacy (MAPS20 subscale) scores. This analysis included participants who completed both T1 and T2 data collection (n = 18).||||0.2208
71798483|NCT06425458|143096643|OTHER||Spearman partial correlation coefficient|0.37|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Esteem). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
71674566|NCT03850483|142867380|SUPERIORITY||LS mean difference|-18.8|STANDARD_ERROR_OF_MEAN|9.53||0.0253|TWO_SIDED|90.0|-34.55|-3.01|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.01|-34.55|0.0253
71674567|NCT03850483|142867380|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|9.38||0.078|TWO_SIDED|90.0|-28.89|2.15|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.15|-28.89|0.0780
71674568|NCT03850483|142867380|SUPERIORITY||LS mean difference|-9.7|STANDARD_ERROR_OF_MEAN|9.36||0.1516|TWO_SIDED|90.0|-25.17|5.83|||MMRM|||Week 6: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.83|-25.17|0.1516
71674569|NCT03850483|142867380|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|9.14||0.4861|TWO_SIDED|90.0|-15.45|14.81|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.81|-15.45|0.4861
71674570|NCT03850483|142867380|SUPERIORITY||LS mean difference|11.0|STANDARD_ERROR_OF_MEAN|9.38||0.8795|TWO_SIDED|90.0|-4.48|26.55|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||26.55|-4.48|0.8795
71674571|NCT03850483|142867380|SUPERIORITY||LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|9.11||0.2867|TWO_SIDED|90.0|-20.22|9.94|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||9.94|-20.22|0.2867
71674572|NCT03850483|142867380|SUPERIORITY||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|9.23||0.1267|TWO_SIDED|90.0|-25.86|4.69|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||4.69|-25.86|0.1267
71798484|NCT06425458|143096643|OTHER||Spearman partial correlation coefficient|-0.29|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Purpose in Life). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
71798485|NCT06425458|143096643|OTHER||Spearman partial correlation coefficient|-0.58|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Locus of Control). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
71798486|NCT06425458|143096643|OTHER||Spearman partial correlation coefficient|-0.14|||||TWO_SIDED|||||||||We conducted an exploratory, descriptive analysis investigating the relationship between leadership program attendance and identity capital at T2, accounting for T1 scores (MAPS20 subscale: Self-Efficacy). This analysis included participants who completed both T1 and T2 data collection (n = 18). We calculated the Spearman correlation coefficient only. Power calculation does not apply for this analysis.||||
71798487|NCT00445328|143096662|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is based on chi-square test with alpha as 0.01.|Chi-squared|||||||1.0000
71798488|NCT00445328|143096664|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Chi-squared|||Major Bleeding||||1.0000
71798489|NCT00445328|143096667|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Chi-squared|||||||0.1355
71798490|NCT02254278|143096668|SUPERIORITY|||||||0.04|||||||binomial|One-sided significance level=0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year progression-free survival (PFS) rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.04
71798491|NCT02254278|143096668|SUPERIORITY|||||||0.23|||||||bionmial|One-sided significance level = 0.10||Assuming a binomial distribution, 140 eligible patients per arm were required for 80% power and 1-sided type I error rate of 10% to test the null hypothesis of 2-year PFS rate ≤ 85% against the alternative hypothesis of \> 85% with a binomial test. The arms are not compared to each other; they are each tested separately against the null hypothesis.||||0.23
71798492|NCT02254278|143096669|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.02|TWO_SIDED|95.0|0.17|0.9|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||0.90|0.17|0.02
71798493|NCT02254278|143096670|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.58|TWO_SIDED|95.0|0.4|5.08|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT 5 weeks|||5.08|0.4|0.58
71798494|NCT02254278|143096671|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.93|TWO_SIDED|95.0|0.31|2.95||Two-side significance level = 0.05|Log Rank||Reference level = IMRT 5 weeks|||2.95|0.31|0.93
71798495|NCT02254278|143096672|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|Two-sided significance level = 0.05||End of RT||||<0.0001
71798496|NCT02254278|143096672|SUPERIORITY|||||||0.17|||||||Fisher Exact|Two-sided significance level = 0.05||One month after end of RT||||0.17
71798497|NCT02254278|143096672|SUPERIORITY|||||||0.16|||||||Fisher Exact|Two-side significance level = 0.05||Six months after end of RT||||0.16
71798498|NCT02254278|143096672|SUPERIORITY|||||||0.26|||||||Fisher Exact|Two-side significance level = 0.05||One year after end of RT||||0.26
71798499|NCT02254278|143096672|SUPERIORITY|||||||0.82|||||||Fisher Exact|Two-side significance level = 0.05||Two years after the end of RT||||0.82
71798500|NCT02254278|143096674|SUPERIORITY|||||||0.3|||||||binomial test|One-sided significance level = 0.10||Progression-free survival: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.3
71798501|NCT02254278|143096674|SUPERIORITY|||||||0.07|||||||binomial test|One-sided significance level = 0.10||Local-regional control: The null hypothesis of negative predictive value ≤ 90% was tested against the alternative of \> 90% with a 1-sided binomial test at the 0.10 level.||||0.07
71798502|NCT02254278|143096675|SUPERIORITY|||||||0.28|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.28
71674573|NCT03850483|142867380|SUPERIORITY||LS mean difference|-17.1|STANDARD_ERROR_OF_MEAN|10.49||0.0526|TWO_SIDED|90.0|-34.48|0.26|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.26|-34.48|0.0526
71674574|NCT03850483|142867380|SUPERIORITY||LS mean difference|-14.3|STANDARD_ERROR_OF_MEAN|10.25||0.0827|TWO_SIDED|90.0|-31.26|2.68|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||2.68|-31.26|0.0827
71798503|NCT02254278|143096676|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.03
71798504|NCT02254278|143096680|SUPERIORITY|||||||0.08|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.08
71798505|NCT02254278|143096681|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Fisher Exact|||||||0.02
71798506|NCT02782949|143096718|SUPERIORITY|||||||0.399|||||||Wilcoxon Rank-Sum test|||||||0.3990
71798507|NCT02782949|143096721|SUPERIORITY|||||||0.74|||||||Fisher Exact|||||||0.74
71798508|NCT03890367|143096723|NON_INFERIORITY|The two-sided 97.5 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.2|5.68|
71798509|NCT03890367|143096724|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
71798510|NCT03890367|143096725|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|16.3|||||TWO_SIDED|97.5|12.7|21.0||||||||21.0|12.7|
71798511|NCT03890367|143096726|SUPERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The superiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>0%.|Difference in Percentage|10.43|||||TWO_SIDED|97.5|5.68|16.2||||||||16.20|5.68|
71798512|NCT03890367|143096727|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.3|2.28||||||||2.28|-2.30|
71798513|NCT03890367|143096728|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
71798514|NCT03890367|143096729|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|1.32|||||TWO_SIDED|97.5|1.06|1.64||||||||1.64|1.06|
71893410|NCT04996797|143307839|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|11.8|36.5|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||36.5|11.8|<.0001
71798515|NCT03890367|143096730|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|5.24|||||TWO_SIDED|97.5|1.83|9.85||||||||9.85|1.83|
71798516|NCT03890367|143096731|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
71798517|NCT03890367|143096732|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|6.8|||||TWO_SIDED|97.5|5.04|9.18||||||||9.18|5.04|
71798518|NCT03890367|143096733|NON_INFERIORITY|The two-sided 97.5% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 97.5% CI of the percentage difference between compared groups was \>-10%.|Difference in Percentage|0.0|||||TWO_SIDED|97.5|-2.71|2.67||||||||2.67|-2.71|
71798519|NCT03890367|143096734|NON_INFERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The non-inferiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1/1.5.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
71798520|NCT03890367|143096735|SUPERIORITY|The two-sided 97.5% CI of the ratio of post-vaccination GMTs was calculated using normal approximation of log-transformed titers. The superiority was demonstrated if the lower limit of the two-sided 97.5% CI of the ratio of GMTs between compared groups was \>1.|GMT Ratio|2.27|||||TWO_SIDED|97.5|1.82|2.84||||||||2.84|1.82|
71798521|NCT02533921|143096736|SUPERIORITY||Mean Difference (Final Values)|1.5022|STANDARD_ERROR_OF_MEAN|0.6749||0.0272|TWO_SIDED|95.0|0.1706|2.8338|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||2.8338|0.1706|0.0272
71798522|NCT02533921|143096737|SUPERIORITY||Mean Difference (Final Values)|-1.1236|STANDARD_ERROR_OF_MEAN|0.8267||0.1761|TWO_SIDED|95.0|-2.7569|0.5097|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.5097|-2.7569|0.1761
71893411|NCT04996797|143307842|SUPERIORITY||Risk Difference (RD)|30.8|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||43.2|17.4|<0.0001
71798523|NCT02533921|143096738|SUPERIORITY||Mean Difference (Final Values)|-0.4616|STANDARD_ERROR_OF_MEAN|0.3889||0.2369|TWO_SIDED|95.0|-1.2291|0.3059|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.3059|-1.2291|0.2369
71798524|NCT02533921|143096739|SUPERIORITY||Mean Difference (Final Values)|-0.1309||||0.7484|TWO_SIDED|95.0|-0.9349|0.673|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|||0.6730|-0.9349|0.7484
71798525|NCT02533921|143096740|SUPERIORITY||Mean Difference (Final Values)|-0.6878|STANDARD_ERROR_OF_MEAN|0.4789||0.1529|TWO_SIDED|95.0|-1.6338|0.2581|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.2581|-1.6338|0.1529
71798526|NCT02533921|143096741|SUPERIORITY||Mean Difference (Final Values)|-0.1608|STANDARD_ERROR_OF_MEAN|0.3934||0.6834|TWO_SIDED|95.0|-0.9382|0.6167|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.||0.6167|-0.9382|0.6834
71798527|NCT03370341|143096742|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.56
71798528|NCT03370341|143096743|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||The null hypothesis was that of no difference in levels of IA between Active and Sham stimulation. A paired samples t-test was performed with a significance level of 0.05 (two-tailed).||||.38
71798529|NCT04368429|143096752|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in percentage was greater than (\>) -10% for the serogroup A.|Difference in percentage|20.27|||||TWO_SIDED|95.0|11.38|28.75|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup A||28.75|11.38|
71798530|NCT04368429|143096752|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup C.|Difference in percentage|33.98|||||TWO_SIDED|95.0|26.2|41.5|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup C||41.50|26.20|
71798531|NCT04368429|143096752|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup Y.|Difference in percentage|34.22|||||TWO_SIDED|95.0|26.66|41.64|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup Y||41.64|26.66|
71798532|NCT04368429|143096752|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was \>-10% for the serogroup W.|Difference in percentage|38.19|||||TWO_SIDED|95.0|28.93|46.53|||||95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Serogroup W||46.53|28.93|
71798533|NCT02610868|143096775|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798534|NCT02610868|143096775|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71893412|NCT04996797|143307843|SUPERIORITY||Risk Difference (RD)|43.8|||<|0.0001|TWO_SIDED|95.0|27.4|56.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||56.9|27.4|<.0001
71893413|NCT04996797|143307844|SUPERIORITY||Risk Difference (RD)|20.8||||0.0224||95.0|2.1|37.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factor of biologic status.|95% CI is estimated using Newcombe method for risk difference.|||37.9|2.1|0.0224
71893414|NCT04996797|143307845|SUPERIORITY||Risk Difference (RD)|13.1||||0.0223||95.0|1.8|24.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||24.6|1.8|0.0223
71798535|NCT02610868|143096775|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798536|NCT02610868|143096775|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798537|NCT02610868|143096775|SUPERIORITY|||||||0.0006|||||||ANCOVA|||||||0.0006
71798538|NCT02610868|143096775|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798539|NCT02610868|143096775|SUPERIORITY|||||||0.1131|||||||ANCOVA|||||||0.1131
71798540|NCT02610868|143096775|SUPERIORITY|||||||0.0026|||||||ANCOVA|||||||0.0026
71798541|NCT02610868|143096775|SUPERIORITY|||||||0.2569|||||||ANCOVA|||||||0.2569
71798542|NCT02610868|143096776|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798543|NCT02610868|143096776|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798544|NCT02610868|143096776|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798545|NCT02610868|143096776|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798546|NCT02610868|143096776|SUPERIORITY|||||||0.313|||||||ANCOVA|||||||0.3130
71798547|NCT02610868|143096776|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798548|NCT02610868|143096776|SUPERIORITY|||||||0.1054|||||||ANCOVA|||||||0.1054
71798549|NCT02610868|143096776|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71798550|NCT02610868|143096776|SUPERIORITY|||||||0.1663|||||||ANCOVA|||||||0.1663
71798551|NCT02610868|143096778|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798552|NCT02610868|143096778|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798553|NCT02610868|143096778|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798554|NCT02610868|143096778|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798555|NCT02610868|143096778|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.1100
71798556|NCT02610868|143096778|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798557|NCT02610868|143096778|SUPERIORITY|||||||1|||||||ANCOVA|||||||1.0000
71798558|NCT02610868|143096778|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798559|NCT02610868|143096778|SUPERIORITY|||||||0.029|||||||ANCOVA|||||||0.0290
71674575|NCT03850483|142867380|SUPERIORITY||LS mean difference|-16.1|STANDARD_ERROR_OF_MEAN|10.26||0.0592|TWO_SIDED|90.0|-33.12|0.86|||MMRM|||Week 8: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-33.12|0.0592
71893415|NCT04996797|143307846|SUPERIORITY||Risk Difference (RD)|28.6||||0.0009||95.0|12.1|42.9|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||42.9|12.1|0.0009
71893416|NCT04996797|143307847|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001||95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
71674576|NCT03850483|142867380|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|9.03||0.4657|TWO_SIDED|90.0|-15.72|14.16|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||14.16|-15.72|0.4657
71674577|NCT03850483|142867380|SUPERIORITY||LS mean difference|3.9|STANDARD_ERROR_OF_MEAN|9.3||0.6612|TWO_SIDED|90.0|-11.52|19.26|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.26|-11.52|0.6612
71674578|NCT03850483|142867380|SUPERIORITY||LS mean difference|-8.5|STANDARD_ERROR_OF_MEAN|9.03||0.1749|TWO_SIDED|90.0|-23.42|6.48|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||6.48|-23.42|0.1749
71798560|NCT02610868|143096779|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798561|NCT02610868|143096779|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798562|NCT02610868|143096779|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798563|NCT02610868|143096779|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798564|NCT02610868|143096779|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798565|NCT02610868|143096779|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
71798566|NCT02610868|143096779|SUPERIORITY|||||||0.9016|||||||ANCOVA|||||||0.9016
71798567|NCT02610868|143096779|SUPERIORITY|||||||0.0753|||||||ANCOVA|||||||0.0753
71798568|NCT02610868|143096779|SUPERIORITY|||||||0.4992|||||||ANCOVA|||||||0.4992
71798569|NCT02610868|143096780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798570|NCT02610868|143096780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798571|NCT02610868|143096780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798572|NCT02610868|143096780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798573|NCT02610868|143096780|SUPERIORITY|||||||0.4567|||||||ANCOVA|||||||0.4567
71798574|NCT02610868|143096780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798575|NCT02610868|143096780|SUPERIORITY|||||||0.8115|||||||ANCOVA|||||||0.8115
71798576|NCT02610868|143096780|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798577|NCT02610868|143096780|SUPERIORITY|||||||0.3282|||||||ANCOVA|||||||0.3282
71798578|NCT02610868|143096782|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798579|NCT02610868|143096782|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798580|NCT02610868|143096782|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798581|NCT02610868|143096782|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798582|NCT02610868|143096782|SUPERIORITY|||||||0.3786|||||||ANCOVA|||||||0.3786
71798583|NCT02610868|143096782|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798584|NCT02610868|143096782|SUPERIORITY|||||||0.7787|||||||ANCOVA|||||||0.7787
71798585|NCT02610868|143096782|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71798586|NCT02610868|143096782|SUPERIORITY|||||||0.3825|||||||ANCOVA|||||||0.3825
71798587|NCT04697628|143096855|SUPERIORITY||Cox Proportional Hazard|0.7||||0.0038|TWO_SIDED|95.0|0.54|0.89||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||Hazard Ratio (HR) was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.89|0.54|0.0038
71798588|NCT04697628|143096856|SUPERIORITY||Cox Proportional Hazard|0.67|||<|0.0001|TWO_SIDED|95.0|0.54|0.82||Two-sided p-value calculated from stratified log-rank test.|Stratified log-rank test||HR was calculated from Cox proportional hazards model and Efron method was used in handling ties and computed using stratification factors at randomization.|||0.82|0.54|<0.0001
71798589|NCT04697628|143096857|SUPERIORITY||Odds Ratio (OR)|4.0|||<|0.0001|TWO_SIDED|95.0|2.1|7.6|||Cochran-Mantel-Haenszel||OR calculated using Cochran-Mantel-Haenszel (CMH) method controlling for stratification factors at randomization.|||7.6|2.1|<0.0001
71798590|NCT01946204|143096865|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.0001|TWO_SIDED|95.0|0.219|0.335|||Log Rank|||Statistical Analysis for TTM by BICR (US Regulatory)||0.335|0.219|<0.0001
71798591|NCT01946204|143096865|SUPERIORITY||Hazard Ratio (HR)|0.279|||<|0.0001|TWO_SIDED|95.0|0.227|0.342|||Log Rank|||Statistical Analysis for TTM by BICR (Ex-US Regulatory)||0.342|0.227|<0.0001
71798592|NCT01946204|143096866|SUPERIORITY||Hazard Ratio (HR)|0.291|||<|0.0001|TWO_SIDED|95.0|0.238|0.356|||Log Rank|||Statistical Analysis for PFS by BICR (US Regulatory)||0.356|0.238|<0.0001
71798593|NCT01946204|143096866|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.247|0.364|||Log Rank|||Statistical Analysis for PFS by BICR (EX-US Regulatory)||0.364|0.247|<0.0001
71798594|NCT01946204|143096867|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.315|0.634|||Log Rank|||Statistical Analysis for Time to Symptomatic Progression||0.634|0.315|<0.0001
71798595|NCT01946204|143096870|SUPERIORITY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.227|0.346|||Log Rank|||Statistical Analysis for MFS by BICR (US Regulatory)||0.346|0.227|<0.0001
71798596|NCT01946204|143096870|SUPERIORITY||Hazard Ratio (HR)|0.297|||<|0.0001|TWO_SIDED|95.0|0.244|0.362|||Log Rank|||Statistical Analysis for MFS by BICR (Ex-US Regulatory)||0.362|0.244|<0.0001
71798597|NCT03466411|143096871|SUPERIORITY||Least Square (LS) Mean Difference|124.2|||<|0.001|TWO_SIDED|95.0|89.8|158.7|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||158.7|89.8|<0.001
71893417|NCT04996797|143307848|SUPERIORITY||Risk Difference (RD)|17.9||||||95.0|-2.4|36.4|||||95% CI is estimated using Newcombe method for risk difference.|||36.4|-2.4|
71893418|NCT04996797|143307849|SUPERIORITY||Risk Difference (RD)|22.8||||||95.0|0.4|42.2|||||95% CI is estimated using Newcombe method for risk difference.|||42.2|0.4|
71893419|NCT04996797|143307850|SUPERIORITY||Risk Difference (RD)|10.2||||||95.0|-6.9|26.9|||||95% CI is estimated using Newcombe method for risk difference.|||26.9|-6.9|
71674579|NCT03850483|142867380|SUPERIORITY||LS mean difference|-9.3|STANDARD_ERROR_OF_MEAN|9.12||0.1548|TWO_SIDED|90.0|-24.39|5.8|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||5.80|-24.39|0.1548
71674580|NCT03850483|142867380|SUPERIORITY||LS mean difference|-21.0|STANDARD_ERROR_OF_MEAN|11.89||0.04|TWO_SIDED|90.0|-40.67|-1.28|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.28|-40.67|0.0400
71798598|NCT03466411|143096871|SUPERIORITY||LS Mean Difference|102.7|||<|0.001|TWO_SIDED|95.0|68.5|136.9|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||136.9|68.5|<0.001
71798599|NCT03466411|143096871|SUPERIORITY||LS Mean Difference|108.7|||<|0.001|TWO_SIDED|95.0|73.9|143.5|||Mixed Model for Repeated Measure||LS Mean difference between the treatment groups and p-values for the comparisons of each guselkumab treatment group with the placebo group were based on MMRM analysis.|||143.5|73.9|<0.001
71798600|NCT03466411|143096872|SUPERIORITY||Adjusted treatment difference|38.1|||<|0.001|TWO_SIDED|95.0|27.3|48.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||48.9|27.3|<0.001
71798601|NCT03466411|143096872|SUPERIORITY||Adjusted treatment difference|42.8|||<|0.001|TWO_SIDED|95.0|31.6|53.9|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||53.9|31.6|<0.001
71798602|NCT03466411|143096873|SUPERIORITY||Adjusted treatment difference|33.7|||<|0.001|TWO_SIDED|95.0|24.1|43.2|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||43.2|24.1|<0.001
71798603|NCT03466411|143096873|SUPERIORITY||Adjusted treatment difference|32.9|||<|0.001|TWO_SIDED|95.0|23.5|42.4|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||42.4|23.5|<0.001
71798604|NCT03466411|143096874|SUPERIORITY||Adjusted treatment difference|34.2|||<|0.001|TWO_SIDED|95.0|23.2|45.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||45.3|23.2|<0.001
71798605|NCT03466411|143096874|SUPERIORITY||Adjusted treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|23.5|46.5|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||46.5|23.5|<0.001
71798606|NCT03466411|143096875|SUPERIORITY||Adjusted treatment difference|27.9|||<|0.001|TWO_SIDED|95.0|18.7|37.1|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||37.1|18.7|<0.001
71798607|NCT03466411|143096875|SUPERIORITY||Adjusted treatment difference|30.8|||<|0.001|TWO_SIDED|95.0|21.3|40.3|||Mantel Haenszel||Treatment difference between guselkumab group and placebo group was based on the common risk difference by use of Mantel-Haenszel stratum weights and the Sato variance estimator.|||40.3|21.3|<0.001
71798608|NCT03466411|143096876|SUPERIORITY||Adjusted treatment difference|25.1|||<|0.001|TWO_SIDED|95.0|14.1|36.2|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.2|14.1|<0.001
71798609|NCT03466411|143096877|SUPERIORITY||Adjusted treatment difference|27.7|||<|0.001|TWO_SIDED|95.0|19.3|36.1|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||36.1|19.3|<0.001
71798610|NCT03466411|143096878|SUPERIORITY||Adjusted treatment difference|31.2|||<|0.001|TWO_SIDED|95.0|21.1|41.3|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||41.3|21.1|<0.001
71798611|NCT03466411|143096879|SUPERIORITY||Adjusted treatment difference|22.1|||<|0.001|TWO_SIDED|95.0|12.2|31.9|||Mantel Haenszel||Treatment difference between combined guselkumab group and placebo group was based on the common risk difference by use of Mantel- Haenszel stratum weights and the Sato variance estimator.|||31.9|12.2|<0.001
71798612|NCT03778931|143096910|OTHER||Hazard Ratio (HR)|0.546||||0.0005|TWO_SIDED|95.0|0.387|0.768|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.768|0.387|0.0005
71798613|NCT03778931|143096911|OTHER||Hazard Ratio (HR)|0.697||||0.0018|TWO_SIDED|95.0|0.552|0.88|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.880|0.552|0.0018
71893420|NCT04996797|143307851|SUPERIORITY||Risk Difference (RD)|28.9||||||95.0|5.0|48.3|||||95% CI is estimated using Newcombe method for risk difference.|||48.3|5.0|
71893421|NCT04996797|143307852|SUPERIORITY||Risk Difference (RD)|22.2|||||TWO_SIDED|95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
71674581|NCT03850483|142867380|SUPERIORITY||LS mean difference|-22.6|STANDARD_ERROR_OF_MEAN|11.6||0.0267|TWO_SIDED|90.0|-41.82|-3.39|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-3.39|-41.82|0.0267
71674582|NCT03850483|142867380|SUPERIORITY||LS mean difference|-22.2|STANDARD_ERROR_OF_MEAN|11.63||0.0295|TWO_SIDED|90.0|-41.42|-2.89|||MMRM|||Week 10: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.89|-41.42|0.0295
71674583|NCT03850483|142867380|SUPERIORITY||LS mean difference|-9.1|STANDARD_ERROR_OF_MEAN|10.38||0.1903|TWO_SIDED|90.0|-26.3|8.05|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||8.05|-26.30|0.1903
71674584|NCT03850483|142867380|SUPERIORITY||LS mean difference|1.4|STANDARD_ERROR_OF_MEAN|10.65||0.553|TWO_SIDED|90.0|-16.21|19.06|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||19.06|-16.21|0.5530
71674585|NCT03850483|142867380|SUPERIORITY||LS mean difference|-13.8|STANDARD_ERROR_OF_MEAN|10.37||0.0933|TWO_SIDED|90.0|-30.92|3.4|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||3.40|-30.92|0.0933
71798614|NCT03778931|143096912|OTHER||Hazard Ratio (HR)|0.592||||0.0325|TWO_SIDED|95.0|0.361|0.958||The p-value was generated by using a two-sided stratified log-rank test.|Log Rank|||The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.||0.958|0.361|0.0325
71798615|NCT03778931|143096913|OTHER||Hazard Ratio (HR)|0.742||||0.0697|TWO_SIDED|95.0|0.536|1.025|||Log Rank|The p-value was generated by using a two-sided stratified log-rank test.|Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-wt), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).|||1.025|0.536|0.0697
71798616|NCT00087633|143096914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.725|TWO_SIDED|95.0|-20.8|14.4|||Cochran-Mantel-Haenszel|||||14.4|-20.8|0.725
71798617|NCT03985813|143096916|SUPERIORITY|||||||0.083||||||Threshold for significance P\<0.05|Chi-squared|||||||0.083
71798618|NCT03985813|143096917|SUPERIORITY||||||>|0.99||||||Threshold for statistical significance P\<0.05|Chi-squared|||||||>0.99
71674586|NCT03850483|142867380|SUPERIORITY||LS mean difference|-19.0|STANDARD_ERROR_OF_MEAN|10.49||0.036|TWO_SIDED|90.0|-36.37|-1.65|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-1.65|-36.37|0.0360
71674587|NCT03850483|142867380|SUPERIORITY||LS mean difference|-24.5|STANDARD_ERROR_OF_MEAN|13.46||0.0354|TWO_SIDED|90.0|-46.85|-2.23|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.23|-46.85|0.0354
71674588|NCT03850483|142867380|SUPERIORITY||LS mean difference|-26.1|STANDARD_ERROR_OF_MEAN|13.07||0.0239|TWO_SIDED|90.0|-47.77|-4.46|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-4.46|-47.77|0.0239
71798619|NCT03306264|143096924|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% confidence interval (CI) of the 5-day AUC0-24 ratio of Least Square Mean (LSM) for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.93|||||TWO_SIDED|90.0|92.66|105.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||105.6|92.66|
71798620|NCT03306264|143096924|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-24 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.64|||||TWO_SIDED|90.0|91.23|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.23|
71798621|NCT03306264|143096930|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.0|||||TWO_SIDED|90.0|91.8|104.6|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.6|91.80|
71798622|NCT03306264|143096930|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-inf ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|99.61|||||TWO_SIDED|90.0|91.2|108.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||108.8|91.20|
71893422|NCT04996797|143307853|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.0001|TWO_SIDED|95.0|14.3|39.6|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||39.6|14.3|<0.0001
71674589|NCT03850483|142867380|SUPERIORITY||LS mean difference|-24.1|STANDARD_ERROR_OF_MEAN|13.11||0.0342|TWO_SIDED|90.0|-45.84|-2.38|||MMRM|||Week 12: MMRM analysis contains treatment, visit, and treatment by visit interaction as fixed factors; and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-2.38|-45.84|0.0342
71674590|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3279|TWO_SIDED|90.0|-0.91|0.52|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.91|0.3279
71674591|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3566|TWO_SIDED|90.0|-0.88|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.88|0.3566
71840835|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-233.626|||<|0.0001|TWO_SIDED|95.0|-261.113|-206.14|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-206.140|-261.113|<.0001
71840836|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|26.266||||0.1672|TWO_SIDED|95.0|-11.13|63.661|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||63.661|-11.130|0.1672
71893423|NCT04996797|143307854|SUPERIORITY||Risk Difference (RD)|22.2||||||95.0|0.2|41.0|||||95% CI is estimated using Newcombe method for risk difference.|||41.0|0.2|
71674592|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.1165|TWO_SIDED|90.0|-1.29|0.21|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.29|0.1165
71674593|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3633|TWO_SIDED|90.0|-0.85|0.55|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.55|-0.85|0.3633
71798623|NCT03306264|143096931|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|91.88|104.8|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.8|91.88|
71798624|NCT03306264|143096931|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-last ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|98.11|||||TWO_SIDED|90.0|89.75|107.2|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||107.2|89.75|
71798625|NCT03306264|143096932|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.93|||||TWO_SIDED|90.0|91.74|104.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|MDS or CMML: IV Decitabine Versus MDS or CMML: ASTX727||104.5|91.74|
71798626|NCT03306264|143096932|EQUIVALENCE|ASTX727 and IV decitabine were to be considered equivalent if the 2-sided 90% CI of the 5-day AUC0-8 ratio of LSM for oral/IV was contained entirely within the range of 0.80 - 1.25.|Ratio of Geometric LSM|97.55|||||TWO_SIDED|90.0|89.32|106.5|||||Analysis was based on ANOVA model with treatment, cycle, and sequence as fixed effects, and participant nested in sequence as a random effect (ratio is Oral/IV).|AML: IV Decitabine Versus AML: ASTX727||106.5|89.32|
71798627|NCT03037528|143096953|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||||||.214
71674594|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.42||0.3766|TWO_SIDED|90.0|-0.83|0.56|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.83|0.3766
71674595|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1179|TWO_SIDED|90.0|-1.22|0.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.20|-1.22|0.1179
71798628|NCT03037528|143096953|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||.017
71798629|NCT03037528|143096953|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||||||.457
71798630|NCT03037528|143096953|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||.580
71798631|NCT03037528|143096953|SUPERIORITY|||||||0.275|||||||t-test, 2 sided|||||||.275
71798632|NCT03037528|143096953|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
71798633|NCT03037528|143096953|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||.007
71798634|NCT03037528|143096953|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||||||.142
71798635|NCT03037528|143096954|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||.027
71798636|NCT03037528|143096954|SUPERIORITY|||||||0|||||||t-test, 2 sided|||||||.000
71893424|NCT04996797|143307855|SUPERIORITY||Risk Difference (RD)|33.1|||<|0.0001||95.0|17.2|46.8|||Cochran-Mantel-Haenszel|P-value is computed using Cochran-Mantel Haenszel (CMH) test with stratification factors of biologic status and CDx status.|95% CI is estimated using Newcombe method for risk difference.|||46.8|17.2|<0.0001
71893425|NCT04996797|143307856|SUPERIORITY||Risk Difference (RD)|19.6||||||95.0|-1.7|38.7|||||95% CI is estimated using Newcombe method for risk difference.|||38.7|-1.7|
71893426|NCT00803114|143307929|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22||||0.05||95.0|0.12|0.41|||Fisher Exact||Relative risk describes the risk of requiring additional analgesics in the first 24 hours postpartum with the denominator being the arm which received placebo.|Relative risk ratio estimation with 95% CI using exact methods||0.41|0.12|0.05
71674596|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.8647|TWO_SIDED|90.0|-0.24|1.2|||MMRM|||Baseline: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.20|-0.24|0.8647
71674597|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.3294|TWO_SIDED|90.0|-0.9|0.52|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-0.90|0.3294
71798637|NCT03037528|143096954|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||.054
71798638|NCT03037528|143096954|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||.014
71798639|NCT03037528|143096954|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||.019
71798640|NCT03037528|143096954|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||||||.026
71798641|NCT03037528|143096954|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||.013
71798642|NCT03037528|143096954|SUPERIORITY|||||||0.163|||||||t-test, 2 sided|||||||.163
71798643|NCT03037528|143096955|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||.018
71798644|NCT03037528|143096955|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||.004
71798645|NCT03037528|143096955|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||||||.134
71798646|NCT03037528|143096955|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71798647|NCT03037528|143096955|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||||||.048
71798648|NCT03037528|143096955|SUPERIORITY|||||||0.066|||||||t-test, 2 sided|||||||.066
71798649|NCT03037528|143096955|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||||||.045
71798650|NCT03037528|143096955|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||||||.053
71798651|NCT00308711|143096976|SUPERIORITY_OR_OTHER||Kaplan-Meier|1595.5||||0.974||||||The a priori threshold for statistical significance was 0.05.|Log Rank||This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.|Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.||||0.974
71798652|NCT00308711|143096976|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1977.0||||0.011||95.0|1977.0|2253.0|||Log Rank|||||2253|1977|0.011
71798653|NCT00308711|143096977|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).|Cox Proportional Hazard|27.8||||0.64||95.0|23.61|32.31|||Fisher Exact|||||32.31|23.61|0.64
71798654|NCT00308711|143096977|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.|Cox Proportional Hazard|28.0||||0.59||95.0|23.86|32.42|||Fisher Exact|||||32.42|23.86|0.59
71798655|NCT04590495|143097011|SUPERIORITY|||||||0.946|||||||Mann Whitney U Test|||||||0.9460
71798656|NCT04590495|143097012|SUPERIORITY|||||||0.5699|||||||Mann Whitney U Test|||||||0.5699
71798657|NCT04590495|143097013|SUPERIORITY|||||||0.6068|||||||t-test, 2 sided|||||||0.6068
71798658|NCT04590495|143097014|SUPERIORITY|||||||0.903|||||||Mann Whitney U Test|||||||0.9030
71798659|NCT04590495|143097015|SUPERIORITY|||||||0.2668|||||||t-test, 2 sided|||||||0.2668
71798660|NCT04590495|143097016|SUPERIORITY|||||||0.8749||||||adjusted for baseline VAMS score|paired t test|||||||0.8749
71798661|NCT04590495|143097017|SUPERIORITY|||||||0.7922||||||adjusted for baseline VAMS score for physical sedation|paired t test|||||||0.7922
71798662|NCT04590495|143097018|SUPERIORITY|||||||0.9925||||||adjusted for baseline SSS score|paired t test|||||||0.9925
71798663|NCT04590495|143097019|SUPERIORITY|||||||0.2628||||||adjusted for baseline score|paired t test|||||||0.2628
71798664|NCT04590495|143097020|SUPERIORITY|||||||0.0347||||||adjusted for baseline scores|paired t test|||||||0.0347
71798665|NCT04590495|143097021|SUPERIORITY|||||||0.6331||||||adjusted for baseline score|paired t test|||||||0.6331
71798666|NCT04590495|143097022|SUPERIORITY|||||||0.472||||||adjusted for baseline score|paired t test|||||||0.4720
71798667|NCT04590495|143097023|SUPERIORITY|||||||0.02||||||adjusted for baseline reaction time|paired t test|||||||0.0200
71798668|NCT04590495|143097024|SUPERIORITY|||||||0.062||||||adjusted for baseline reaction time|paired t test|||||||0.0620
71798669|NCT03591575|143097030|SUPERIORITY|||||||0.0446|||||||Fisher Exact|||Patients who reached the serum ferritin threshold at any time point prior to Month 12 were withdrawn from the study as per protocol, so that they could begin on standard chelation therapy. For these individuals, imputed data were used to estimate the values that would likely have been seen at Month 12 had they remained in the study.||||0.0446
71798670|NCT03591575|143097031|SUPERIORITY|||||||0.0446||||||he p-value shown here is for the difference between the groups at Month 12.|Fisher Exact|||||||0.0446
71798671|NCT02026115|143097066|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
71798672|NCT02026115|143097067|SUPERIORITY|||||||0.02||||||Experimental group performed worse than usual care.|Mixed Models Analysis|||||||.02
71798673|NCT02026115|143097068|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||.32
71798674|NCT02026115|143097069|SUPERIORITY|||||||0.36|||||||Regression, Logistic|||||||.36
71798675|NCT02026115|143097070|SUPERIORITY|||||||0.01|||||||Regression, Linear|||||||.01
71798676|NCT02026115|143097071|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71798677|NCT04084769|143097109|OTHER|95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction.|Difference in percentage|1.65|||||TWO_SIDED|95.0|-3.58|6.95||||||Serogroup A||6.95|-3.58|
71840837|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.051||||0.014|TWO_SIDED|95.0|-71.881|-8.221|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-8.221|-71.881|0.0140
71840838|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.635||||0.0288|TWO_SIDED|95.0|-80.785|-4.484|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-4.484|-80.785|0.0288
71840839|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-274.577|||<|0.0001|TWO_SIDED|95.0|-345.428|-203.726|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-203.726|-345.428|<.0001
71840840|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-207.521|||<|0.0001|TWO_SIDED|95.0|-269.198|-145.844|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-145.844|-269.198|<.0001
71840841|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.233|||<|0.0001|TWO_SIDED|95.0|-275.683|-130.784|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-130.784|-275.683|<.0001
71893427|NCT00803114|143307930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|0.8||0.05||95.0|-5.7|-2.3|||t-test, 2 sided|degrees of freedom 226|The epidural morphine group represents the baseline of comparison for difference in means, with the placebo group requiring additional analgesics earlier.|||-2.3|-5.7|0.05
71893428|NCT00803114|143307931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3||0.05||95.0|0.7|1.8|||t-test, 2 sided|degrees of freedom 212|Difference in VAS score when compared to the baseline group, subjects receiving epidural morphine|||1.8|0.7|0.05
71893429|NCT00803114|143307932|SUPERIORITY_OR_OTHER|||||||0.8||||||Fisher's exact test result did not reveal statistically significant differences between expected and real frequencies in any of the categories.|Fisher Exact|||||||0.80
71893430|NCT01697345|143307934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.092|STANDARD_DEVIATION|6.0378|<|0.0005|TWO_SIDED|95.0|-13.928|-6.256|||t-test, 2 sided|||||-6.256|-13.928|<0.0005
71674598|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.44||0.1231|TWO_SIDED|90.0|-1.23|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.23|0.1231
71674599|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0878|TWO_SIDED|90.0|-1.37|0.13|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.13|-1.37|0.0878
71798678|NCT04084769|143097109|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.74|||||TWO_SIDED|95.0|-5.5|1.6||||||Serogroup C||1.60|-5.50|
71798679|NCT04084769|143097109|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.15|||||TWO_SIDED|95.0|-4.09|1.14||||||Serogroup Y||1.14|-4.09|
71798680|NCT04084769|143097109|OTHER|95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction.|Difference in percentage|-1.16|||||TWO_SIDED|95.0|-4.72|2.07||||||Serogroup W||2.07|-4.72|
71798681|NCT03390504|143097119|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0031|TWO_SIDED|95.0|0.48|0.86|||Log Rank|||||0.86|0.48|=0.0031
71798682|NCT03390504|143097119|SUPERIORITY||Hazard Ratio (HR)|1.16|||=|0.2121|TWO_SIDED|95.0|0.92|1.48|||Stratified log-rank test|||||1.48|0.92|=0.2121
71798683|NCT03091192|143097224|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.313|TWO_SIDED|95.0|0.37|1.36|||Log Rank|||||1.36|0.37|0.313
71798684|NCT03091192|143097225|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.11|TWO_SIDED|95.0|0.21|1.17|||Log Rank||A hazard ratio \< 1 favours Savolitinib|||1.17|0.21|0.110
71798685|NCT01706952|143097231|SUPERIORITY_OR_OTHER|For surgical field grade, we calculated the mean within sides and assessed its difference, reporting a 95% confidence interval as calculated by a Student t test. We used the average per patient over time.||||||0.05|||||||t-test, 2 sided|||Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p \< 0.05).|"For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference, reporting a 95% con- fidence interval as calculated by a Student t test. As all of these values were measured over time, we used the average per patient over time. The total blood loss per side within subjects was also calculated, with 95% confidence interval again calculated by a Student t test. Once again, we took the average per patient over time as the main outcome.~Finally, we used a linear regression with surgical field improvement as the outcome and HR, MAP, or etCO2 as covariates, to investigate which variables may be related to the outcome. As these measures were taken over time, we used repeated measures analysis to investigate how these items correlate over time.~In addition to the operating surgeon, the statistician was blinded to the vasoconstrictor allocation."|||0.05
71798686|NCT02453113|143097240|SUPERIORITY||||||||||||||||||The statistical end point of the study will be the changes in density of CD11c+ dermal dendritic cells between two biopsies from a study subject where one sample is subjected to laser irradiation and the other is the control. For assessment of statistical significance, we will apply a paired sample t-test.|||
71798687|NCT02896400|143097254|SUPERIORITY||Odds Ratio (OR)|1.8||||0.01|TWO_SIDED|95.0|1.1|2.8|||Regression, Logistic|Adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including BNI (BNI only, BNI+NRT, BNI+QL, BNI+Text, BNI+NRT+QL, BNI+NRT+Text, BNI+QL+Text, BNI+NRT+QL+Text) compared to the 8 arms that do not include BNI (Control, NRT only, QL only, Text only, NRT+QL, NRT+Text, QL+Text, NRT+QL+Text)||2.8|1.1|.01
71798688|NCT02896400|143097254|SUPERIORITY||Odds Ratio (OR)|2.1||||0.001|TWO_SIDED|95.0|1.3|3.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms that include NRT (NRT only, BNI+NRT, NRT+QL, NRT+Text, BNI+NRT+QL, BNI+NRT+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include NRT (Control, BNI only, QL only, Text only, BNI+QL, BNI+Text, QL+Text, BNI+QL+Text)||3.2|1.3|.001
71798689|NCT02896400|143097254|SUPERIORITY||Odds Ratio (OR)|1.4||||0.14|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including QL intervention (QL only, BNI+QL, NRT+QL, QL+Text, BNI+NRT+QL, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to all 8 arms that did not include QL (Control, BNI only, NRT only, Text only, BNI+NRT, BNI+Text, NRT+Text, BNI+NRT+Text)||2.2|0.9|0.14
71893431|NCT01697345|143307935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_DEVIATION|0.88|<|0.0005|TWO_SIDED|95.0|-1.859|-0.741|||t-test, 2 sided|||||-0.741|-1.859|<0.0005
71674600|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.1225|TWO_SIDED|90.0|-1.2|0.21|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.21|-1.20|0.1225
71674601|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3663|TWO_SIDED|90.0|-0.85|0.56|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.56|-0.85|0.3663
71798690|NCT02896400|143097254|SUPERIORITY||Odds Ratio (OR)|1.1||||0.64|TWO_SIDED|95.0|0.7|1.7|||Regression, Logistic|adjusted for gender, age, race/ethnicity, baseline daily cigarette consumption||8 arms including Text (Text only, BNI+Text, NRT+Text, QL+Text, BNI+NRT+Text, BNI+QL+Text, NRT+QL+Text, BNI+NRT+QL+Text) compared to 8 arms that do not include Text (Control, BNI only, NRT only, QL only, BNI+NRT, BNI+QL, NRT+QL, BNI+NRT+QL)||1.7|0.7|0.64
71798691|NCT02984020|143097268|OTHER||Odds Ratio (OR)|0.77|||<|0.0001||95.0|0.69|0.86|||Regression, Logistic|Multiple logistic regression including total treatment duration of Xeljanz as factor||||0.86|0.69|<0.0001
71798692|NCT02984020|143097268|OTHER||Odds Ratio (OR)|2.43|||<|0.0001||95.0|1.64|3.59|||Regression, Logistic|Multiple logistic regression including other past/present disease as factor||||3.59|1.64|<0.0001
71798693|NCT02984020|143097279|OTHER||Odds Ratio (OR)|1.42||||0.0053|TWO_SIDED|95.0|1.11|1.82|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Xeljanz as factor||||1.82|1.11|0.0053
71798694|NCT00667342|143097287|OTHER|The association between response and Ktrans at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
71893432|NCT01697345|143307936|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.625|STANDARD_DEVIATION|1.369||0.002|TWO_SIDED|95.0|-2.495|-0.755|||t-test, 2 sided|||||-0.755|-2.495|0.002
71893433|NCT01697345|143307937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|1.876||0.018|TWO_SIDED|95.0|-2.692|-0.308|||t-test, 2 sided|||||-0.308|-2.692|0.018
71798695|NCT00667342|143097288|OTHER|The association between response and Vp at Week 10 was evaluated.||||||0.0573|||||||Logistic Regression|||||||0.0573
71798696|NCT00667342|143097289|OTHER|The association between response and Ve at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression|||||||0.0863
71798697|NCT01110915|143097359|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|97.5||2.5||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI \>=10%.||2.5||<0.0001
71798698|NCT01110915|143097360|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.0|||||||||||Farrington-Manning test|A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
71798699|NCT01110915|143097361|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.5|||<|0.0001|TWO_SIDED|95.0|-5.0|5.9||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||5.9|-5.0|<0.0001
71798700|NCT01110915|143097362|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|1.5||||0.001|ONE_SIDED|95.0|-6.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-6.1|0.0010
71798701|NCT01110915|143097363|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Difference in percentages|0.1||||0.0001|ONE_SIDED|95.0|-4.6|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.6|0.0001
71798702|NCT01110915|143097364|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9||A priori threshold for statistical significance was 0.05.|exact test of binomial proportions|||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
71798703|NCT01110915|143097365|SUPERIORITY_OR_OTHER||Complication rate at 4 months|7.7|||<|0.05|ONE_SIDED|95.0||10.9||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit \>= 20%.||10.9||<0.05
71798704|NCT00207142|143097366|NON_INFERIORITY_OR_EQUIVALENCE|Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.|Difference in proportions|2.9||||||95.0|-9.8|15.5|||Normal approximation|||The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.||15.5|-9.8|
71798705|NCT00207142|143097367|SUPERIORITY_OR_OTHER||Difference in Proportions|5.0||||||95.0|-6.0|16.1|||Normal Approximation|||||16.1|-6.0|
71840842|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-261.208|||<|0.0001|TWO_SIDED|95.0|-330.647|-191.769|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-191.769|-330.647|<.0001
71893434|NCT01697345|143307938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.18168||0.005|TWO_SIDED|95.0|-1.9508|-0.4492|||t-test, 2 sided|||||-.44920|-1.95080|0.005
71893435|NCT01697345|143307939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|1.355||0.001|TWO_SIDED|95.0|-2.761|-1.039|||t-test, 2 sided|||||-1.039|-2.761|0.001
71798706|NCT00207142|143097368|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||||95.0|0.5|1.88|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen.||1.88|0.50|
71798707|NCT00207142|143097369|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||||95.0|0.37|1.9|||Cox Proportional Hazards Model|||Covariate in the model: treatment regimen||1.90|0.37|
71798708|NCT00207142|143097370|SUPERIORITY_OR_OTHER||Difference in means at Week 48|7.0||||||95.0|-38.0|53.0|||Normal approximation|||||53|-38|
71798709|NCT00835497|143097403|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|86.5||||||90.0|81.8|91.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||91.6|81.8|
71798710|NCT00835497|143097404|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.9|94.2|
71893436|NCT01697345|143307940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.567|STANDARD_DEVIATION|1.793|<|0.0005|TWO_SIDED|95.0|-3.706|-1.428|||t-test, 2 sided|||||-1.428|-3.706|<0.0005
71798711|NCT00835497|143097405|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||99.8|94.2|
71798712|NCT00835497|143097406|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|88.9||||||90.0|83.5|94.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||94.6|83.5|
71798713|NCT00835497|143097407|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|88.4|97.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.1|88.4|
71798714|NCT00835497|143097408|NON_INFERIORITY_OR_EQUIVALENCE|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|88.8|97.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||97.5|88.8|
71798715|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.264|TWO_SIDED|95.0|-0.019|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.019|0.264
71798716|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.033||||0.165|TWO_SIDED|95.0|-0.013|0.079|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.079|-0.013|0.165
71798717|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.026||||0.271|TWO_SIDED|95.0|-0.02|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.071|-0.020|0.271
71798718|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.100|0.010|0.018
71798719|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.055||||0.018|TWO_SIDED|95.0|0.01|0.101|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.101|0.010|0.018
71798720|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.078|||<|0.001|TWO_SIDED|95.0|0.032|0.124|||Mixed Models Analysis|||||0.124|0.032|<0.001
71798721|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.052||||0.023|TWO_SIDED|95.0|-0.097|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.097|0.023
71798722|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.051|TWO_SIDED|95.0|-0.091|0.0|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.000|-0.091|0.051
71798723|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.053||||0.023|TWO_SIDED|95.0|-0.098|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-0.007|-0.098|0.023
71798724|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023||||0.306|TWO_SIDED|95.0|-0.068|0.021|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.021|-0.068|0.306
71798725|NCT01573624|143097411|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.023||||0.33|TWO_SIDED|95.0|-0.068|0.023|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.023|-0.068|0.330
71798726|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.9|||<|0.001|TWO_SIDED|95.0|9.5|22.3|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.3|9.5|<0.001
71798727|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.4|||<|0.001|TWO_SIDED|95.0|10.9|23.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||23.9|10.9|<0.001
71798728|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|12.1|25.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||25.1|12.1|<0.001
71893437|NCT01392183|143307947|SUPERIORITY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.84|2.22|||||Adjusted Hazard Ratio comparing Median PFS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||2.22|0.84|
71674602|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0929|TWO_SIDED|90.0|-1.27|0.14|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.27|0.0929
71798729|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.5|29.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.4|16.5|<0.001
71798730|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.0|||<|0.001|TWO_SIDED|95.0|15.5|28.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.4|15.5|<0.001
71798731|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0|||<|0.001|TWO_SIDED|95.0|20.6|33.5|||Mixed Models Analysis|||||33.5|20.6|<0.001
71798732|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-17.6|-4.7|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-4.7|-17.6|<0.001
71798733|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6||||0.004|TWO_SIDED|95.0|-16.1|-3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.1|-16.1|0.004
71798734|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.4||||0.012|TWO_SIDED|95.0|-14.9|-1.9|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-1.9|-14.9|0.012
71798735|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.209|TWO_SIDED|95.0|-10.6|2.3|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||2.3|-10.6|0.209
71798736|NCT01573624|143097412|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1||||0.124|TWO_SIDED|95.0|-11.6|1.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.4|-11.6|0.124
71798737|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.2|||<|0.001|TWO_SIDED|95.0|9.5|22.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||22.9|9.5|<0.001
71798738|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.2|||<|0.001|TWO_SIDED|95.0|10.5|24.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||24.0|10.5|<0.001
71798739|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.2|||<|0.001|TWO_SIDED|95.0|14.4|28.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||28.0|14.4|<0.001
71798740|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.5|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||35.5|22.1|<0.001
71798741|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.9|||<|0.001|TWO_SIDED|95.0|16.2|29.6|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||29.6|16.2|<0.001
71798742|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6|||<|0.001|TWO_SIDED|95.0|19.8|33.4|||Mixed Models Analysis|||||33.4|19.8|<0.001
71798743|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3||||0.003|TWO_SIDED|95.0|-17.2|-3.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-3.5|-17.2|0.003
71798744|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.007|TWO_SIDED|95.0|-16.2|-2.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||-2.5|-16.2|0.007
71798745|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.4||||0.126|TWO_SIDED|95.0|-12.3|1.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||1.5|-12.3|0.126
71798746|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.523||95.0|-4.6|9.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||9.1|-4.6|0.523
71798747|NCT01573624|143097413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7||||0.29|TWO_SIDED|95.0|-10.5|3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||3.1|-10.5|0.290
71798748|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.036|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.036
71798749|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.064|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.064
71798750|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.335|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.1|-0.3|0.335
71798751|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.012|TWO_SIDED|95.0|-0.5|-0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||-0.1|-0.5|0.012
71798752|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.023|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.||0.0|-0.5|0.023
71798753|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Models Analysis|||||-0.2|-0.7|<0.001
71798754|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.104|TWO_SIDED|95.0|0.0|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|0.0|0.104
71798755|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.062|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.5|0.0|0.062
71798756|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.006|TWO_SIDED|95.0|0.1|0.6|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.6|0.1|0.006
71798757|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.217|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.217
71798758|NCT01573624|143097414|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.143|TWO_SIDED|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.||0.4|-0.1|0.143
71798759|NCT00554749|143097427|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.09|STANDARD_DEVIATION|0.43|<|0.001||95.0|1.69|2.49|||paired t-test|Paired t-test of SSQ at baseline vs at 6 months, degrees of freedom=6. Difference in SSQ is reported.||||2.49|1.69|<0.001
71798760|NCT03417141|143097429|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Week 12||||0.014
71798761|NCT03417141|143097429|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.006
71798762|NCT03417141|143097430|SUPERIORITY|||||||0.093|||||||Wilcoxon (Mann-Whitney)|||||||0.093
71798763|NCT03417141|143097431|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71798764|NCT03417141|143097432|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71798765|NCT03706690|143097433|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.038|TWO_SIDED|95.0|0.578|0.986|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for the level of programmed death ligand 1 (PD-L1) expression (PD-L1 \<1% versus \[vs\] PD-L1 \>=1%) and prior therapy (concurrent \[c\]CRT vs sequential \[s\]CRT), with treatment as the only covariate and ties handled by Efron approach.||0.986|0.578|0.038
71893438|NCT01392183|143307948|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.7|1.93|||||Adjusted HR comparing Median OS of pazopanib (treatment group) to Temsirolimus (control group) as first line of treatment. HR \>1 treatment group performed better, \< 1 the control group performed better =1 groups performed equally.|||1.93|0.7|
71893439|NCT03430310|143307949|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71893440|NCT02770807|143307995|SUPERIORITY||Least squares mean difference|-1.37||||0.0847|TWO_SIDED|95.0|-2.932|0.19|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.190|-2.932|0.0847
71893441|NCT02770807|143307995|SUPERIORITY||Least squares mean difference|-1.4||||0.0765|TWO_SIDED|95.0|-2.957|0.152|||Mixed model for repeated measures|||Least squares means, and p-values are derived from a mixed model repeated measures analysis with baseline modified ICARS value as covariate and the fixed effects of treatment, age, sex, region and visit and the interaction term treatment-by-visit.||0.152|-2.957|0.0765
71893442|NCT02770807|143307996|SUPERIORITY||Odds Ratio (OR)|0.946||||0.8919|TWO_SIDED|95.0|0.426|2.099|||Regression, Logistic|||Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region as fixed effects.||2.099|0.426|0.8919
71893443|NCT02770807|143307996|SUPERIORITY||Odds Ratio (OR)|1.848||||0.1255|TWO_SIDED|95.0|0.842|4.053|||Regression, Logistic|||"Logistic regression modeling (0/1), where 0 = No change or worsening and 1= improvement, with age (at 2 levels:~\<10 years, ≥10 years), sex, treatment, region as fixed effects."||4.053|0.842|0.1255
71893444|NCT02770807|143307997|SUPERIORITY||Odds Ratio (OR)|1.369||||0.4583|TWO_SIDED|95.0|0.597|3.144|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.144|0.597|0.4583
71893445|NCT02770807|143307997|SUPERIORITY||Odds Ratio (OR)|1.371||||0.4585|TWO_SIDED|95.0|0.595|3.16|||Ordinal Logistic Regression Analysis|||Odds ratio, confidence limits, and p-value derived using a proportional odds ordinal logistic regression analysis, with age (at 2 levels: \<10 years, ≥10 years), sex, treatment, region, visit, baseline CGI-S score, and treatment-by- visit interaction as fixed effects.||3.160|0.595|0.4585
71893446|NCT02770807|143307998|SUPERIORITY||Least squares means difference|-13.33||||0.7029|TWO_SIDED|95.0|-82.261|55.601|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||55.601|-82.261|0.7029
71893447|NCT02770807|143307998|SUPERIORITY||Least squares means difference|-77.31||||0.0328|TWO_SIDED|95.0|-148.201|-6.421|||ANCOVA|||Least squares means difference, associated statistics, and p-values derived using ANCOVA, with age (at 2 levels: \<10 years, \>=10 years), sex, treatment, region, and baseline VABS score as fixed effects.||-6.421|-148.201|0.0328
71893448|NCT01056107|143308016|SUPERIORITY_OR_OTHER|||||||0.0075||95.0|||||Dunnett's test|||||||0.0075
71798766|NCT03706690|143097434|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.656|1.166|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.166|0.656|0.346
71798767|NCT03706690|143097434|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.346|TWO_SIDED|95.0|0.663|1.162|||Log Rank|Analysis performed using stratified log-rank test, adjusting for level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1 \>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.162|0.663|0.346
71798768|NCT03706690|143097435|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.026|TWO_SIDED|95.0|0.575|0.966|||Log Rank|Analysis performed using stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs sCRT).||The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs PD-L1\>=1%) and prior therapy (cCRT vs sCRT), with treatment as the only covariate and ties handled by Efron approach.||0.966|0.575|0.026
71674603|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.3111|TWO_SIDED|90.0|-0.95|0.51|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-0.95|0.3111
71798769|NCT03706690|143097437|SUPERIORITY||Odds Ratio (OR)|1.51||||0.128|TWO_SIDED|95.0|0.891|2.607|||Regression, Logistic|||For mITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.607|0.891|0.128
71798770|NCT03706690|143097437|SUPERIORITY||Odds Ratio (OR)|1.54||||0.105|TWO_SIDED|95.0|0.915|2.638|||Regression, Logistic|||For ITT set. The comparison was performed using a logistic regression model, with treatment as a covariate and adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with 95% CI calculated by profile likelihood.||2.638|0.915|0.105
71798771|NCT03706690|143097440|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.275|TWO_SIDED|95.0|0.648|1.138|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.138|0.648|0.275
71798772|NCT03706690|143097440|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.241|TWO_SIDED|95.0|0.648|1.122|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.122|0.648|0.241
71798773|NCT03706690|143097441|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.769|TWO_SIDED|95.0|0.726|1.578|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For mITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.578|0.726|0.769
71893449|NCT01056107|143308016|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Dunnett's test|||||||<0.001
71893450|NCT01614457|143308039|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|2.1114||||0.1979|TWO_SIDED|95.0|-1.1305|5.3532|||Mixed Model Repeated Measures|||Analysis was based on mixed effects model for repeated measures (MMRM) with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, using compound symmetry covariance matrix.||5.3532|-1.1305|0.1979
71674604|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.4745|TWO_SIDED|90.0|-0.74|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.69|-0.74|0.4745
71798774|NCT03706690|143097441|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.812|TWO_SIDED|95.0|0.726|1.539|||Log Rank|The analysis was performed using the stratified log-rank test, adjusting for the level of PD-L1 expression and prior therapy (cCRT vs. sCRT).||For ITT set. The hazard ratio and CIs were calculated using a stratified Cox proportional hazards model, adjusting for the level of PD-L1 expression (PD-L1 \<1% vs. PD-L1 \>=1%) and prior therapy (cCRT vs. sCRT), with treatment as the only covariate and ties handled by Efron approach.||1.539|0.726|0.812
71798775|NCT03467425|143097463|SUPERIORITY||Odds Ratio (OR)|1.31|||<|0.001|TWO_SIDED|95.0|1.13|1.51||Analysis was performed using logistic regression model with covariates of treatment group, Baseline CAT score, number of exacerbations in the prior year, actual prior medication use strata and country.|Regression, Logistic||Statistical comparison is presented for combined data of responders, non-responders and those with imputed CAT score at Week 24.|||1.51|1.13|<0.001
71798776|NCT03467425|143097464|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.0121|<|0.001|TWO_SIDED|95.0|0.026|0.073|||ANCOVA||Analysis was performed using an ANCOVA with covariates of treatment group, Baseline FEV1, actual prior medication use strata, country and timing of spirometry.|||0.073|0.026|<0.001
71798777|NCT03467425|143097465|SUPERIORITY||Odds Ratio (OR)|1.99||||0.103|TWO_SIDED|95.0|0.87|4.53|||Regression, Logistic||Analysis was performed using logistic regression model with covariates of treatment group, actual prior medication use strata and country.|||4.53|0.87|0.103
71798778|NCT02318693|143097466|SUPERIORITY_OR_OTHER||LS Means Difference|-8.8||||0.245|TWO_SIDED|95.0|-23.8|6.2|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||6.2|-23.8|0.245
71798779|NCT02318693|143097467|SUPERIORITY_OR_OTHER||LS Means Difference|-5.9||||0.029|TWO_SIDED|95.0|-11.3|-0.6|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.6|-11.3|0.029
71798780|NCT02318693|143097468|SUPERIORITY_OR_OTHER||LS Means Difference|-12.8||||0.041|TWO_SIDED|95.0|-25.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-25.1|0.041
71798781|NCT02318693|143097468|SUPERIORITY_OR_OTHER||LS Means Difference|-14.3||||0.043|TWO_SIDED|95.0|-28.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.||-0.5|-28.1|0.043
71798782|NCT02318693|143097468|SUPERIORITY_OR_OTHER||LS Means Difference|5.1||||0.509|TWO_SIDED|95.0|-10.3|20.4|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.||20.4|-10.3|0.509
71798783|NCT02318693|143097469|SUPERIORITY_OR_OTHER||LS Means Difference|15.7||||0.02|TWO_SIDED|95.0|2.5|28.8|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.||28.8|2.5|0.020
71798784|NCT02318693|143097470|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1||||0.134|TWO_SIDED|95.0|-2.5|0.3|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.3|-2.5|0.134
71798785|NCT02318693|143097470|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.226|TWO_SIDED|95.0|-1.5|0.4|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.4|-1.5|0.226
71798786|NCT02318693|143097470|SUPERIORITY_OR_OTHER||LS Means Difference|0.0||||0.332|TWO_SIDED|95.0|-0.1|0.0|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values \< 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.||0.0|-0.1|0.332
71798787|NCT00025883|143097471|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within GLD group.||||<0.001
71798788|NCT00025883|143097471|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within PLD group.||||0.004
71893451|NCT01614457|143308040|SUPERIORITY_OR_OTHER||LS Mean difference|0.2626||||0.778|TWO_SIDED|95.0|-1.5698|2.095||p-value for the treatment effect is from the slope of BMI (kg/m2) versus time (days).|Linear Mixed model|||Analysis was based on linear mixed model with dependent variable BMI and treatment as a fixed effect, adjustment for baseline percent predicted FEV1, age and visit by treatment interaction was included as covariates and intercept, visit were included as random effects.||2.0950|-1.5698|0.7780
71674605|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2409|TWO_SIDED|90.0|-1.03|0.42|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.03|0.2409
71840843|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-203.998|||<|0.0001|TWO_SIDED|95.0|-263.396|-144.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.599|-263.396|<.0001
71798789|NCT00025883|143097472|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within GLD group.||||0.05
71798790|NCT00025883|143097472|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within PLD group.||||0.02
71798791|NCT03080961|143097473|OTHER||SADE percentage|0.0|||||TWO_SIDED|95.0|0.0|7.7||||||SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.||7.7|0.0|
71798792|NCT03080961|143097474|SUPERIORITY|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.||||0.248
71798793|NCT03080961|143097475|SUPERIORITY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71798794|NCT04487080|143097496|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0002|TWO_SIDED|95.0|0.58|0.85|||Log Rank||HR and its 95% CI was estimated based on a stratified Cox's regression model with treatment as the sole explanatory variable.|||0.85|0.58|0.0002
71798795|NCT02449356|143097566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71798796|NCT02449356|143097567|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71798797|NCT00533949|143097572|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.38||||0.0042|TWO_SIDED|95.0|1.09|1.76|||Log Rank||Reference group = 60 gy|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.76|1.09|0.0042
71798798|NCT00533949|143097572|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.07||||0.29|TWO_SIDED|95.0|0.84|1.35|||Log Rank||Reference level = cetuximab|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 \& 3 vs arms 2 \& 4; for cetuximab, arms 1 \& 2 vs arms 3 \& 4.||1.35|0.84|0.29
71798799|NCT00533949|143097573|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.19||||0.12|TWO_SIDED|95.0|0.95|1.47|||Log Rank||Reference level = 60 Gy|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.47|0.95|0.12
71798800|NCT00533949|143097573|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.89|TWO_SIDED|95.0|0.8|1.22|||Log Rank||Reference level = cetuximab|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05.||1.22|0.80|0.89
71798801|NCT00533949|143097574|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.24|TWO_SIDED|95.0|0.89|1.53|||Gray's test||Reference level = 60 Gy|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.53|0.89|0.24
71798802|NCT00533949|143097574|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.22|TWO_SIDED|95.0|0.64|1.1|||Gray's test||Reference level = cetuximab|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.||1.10|0.64|0.22
71798803|NCT00533949|143097575|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Esophagitis: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||<0.0001
71840844|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-178.75|||<|0.0001|TWO_SIDED|95.0|-249.092|-108.408|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-108.408|-249.092|<.0001
71840845|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-190.992|||<|0.0001|TWO_SIDED|95.0|-237.134|-144.85|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-144.850|-237.134|<.0001
71840846|NCT04800211|143190996|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-24.483||||0.359|TWO_SIDED|95.0|-77.096|28.13|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||28.130|-77.096|0.3590
71840847|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.287|||<|0.0001|TWO_SIDED|95.0|-2.582|-1.992|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-1.992|-2.582|<.0001
71896283|NCT03114969|143314781|SUPERIORITY||Odds Ratio (OR)|2.71||||0.01|TWO_SIDED|95.0|1.274|5.764||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.764|1.274|0.010
71798804|NCT00533949|143097575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|||||||Chi-squared|||PNEUMONITIS: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.||||0.2533
71798805|NCT00533949|143097576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|||||||Chi-squared|||Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of of toxicity at any time was classified by a binary grouping of \< grade 3 and \>= grade 3. Comparisons were made using a two-sided chi-square test.||||0.52
71798806|NCT00533949|143097578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0233|||||||Cochran-Mantel-Haenszel|||FACT-TOI-LCS was assessed and changes from baseline to 3 months calculated and grouped using a 2 point decline as the threshold. Comparisons of decline vs no decline by RT level were from a Cochran-Mantel-Haenszel test and controlling for cetuximab assignment using a two-side significance level of 0.05.||||0.0233
71798807|NCT00533949|143097579|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.92
71798808|NCT00533949|143097580|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Two-sided significance level = 0.05||||||0.19
71798809|NCT00533949|143097581|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.78|TWO_SIDED|95.0|0.68|1.33|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of overall survival by EGFR group||1.33|0.68|0.78
71798810|NCT00533949|143097581|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.61|TWO_SIDED|95.0|0.74|1.65|||Regression, Cox||Reference level = EGFR H-Score \< 200|Univariate model of time to local-regional failure by EGFR group||1.65|0.74|0.61
71798811|NCT00533949|143097582|SUPERIORITY|||||||0.02||||||Two-sided significance level = 0.05|Chi-squared|||||||0.02
71798812|NCT00533949|143097583|OTHER||Cox Proportional Hazard|1.001||||0.06|TWO_SIDED|95.0|1.0|1.002||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Univariate model with GTV as a continuous variable||1.002|1.000|0.06
71798813|NCT00533949|143097583|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.78|TWO_SIDED|95.0|0.997|1.004||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Multivariate model with GTV as a continuous variable, adjusting for planned radiation therapy dose group (60 Gy or 74 Gy) and the interaction of GTV and planned dose.|P-Value for the interaction of GTV and planned dose = 0.77|1.004|0.997|0.78
71798814|NCT00533949|143097584|SUPERIORITY||Cox Proportional Hazard|1.0||||0.94|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of overall survival time by PET SUV as a continuous variable||1.02|0.98|0.94
71798815|NCT00533949|143097584|SUPERIORITY||Cox Proportional Hazard|1.0||||0.72|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to local-regional failure by PET SUV as a continuous variable||1.02|0.98|0.72
71798816|NCT00533949|143097584|SUPERIORITY||Cox Proportional Hazard|1.0||||0.79|TWO_SIDED|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to distant metastasis by PET SUV as a continuous variable||1.02|0.98|0.79
71798817|NCT00727194|143097586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.25||||0.0144|TWO_SIDED|95.0|-7.45|-1.05||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||-1.05|-7.45|0.0144
71798818|NCT00727194|143097586|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.71||||0.117|TWO_SIDED|95.0|-10.8|1.37||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||1.37|-10.80|0.1170
71798819|NCT00727194|143097587|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||1.0000
71798820|NCT00727194|143097587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0606|TWO_SIDED|||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared|||||||0.0606
71840848|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.415|||<|0.0001|TWO_SIDED|95.0|-2.722|-2.107|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.107|-2.722|<.0001
71840849|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.382|||<|0.0001|TWO_SIDED|95.0|-2.673|-2.09|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-2.090|-2.673|<.0001
71896284|NCT03114969|143314782|SUPERIORITY||Odds Ratio (OR)|2.503||||0.108|TWO_SIDED|95.0|0.818|7.659||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.659|0.818|0.108
71798821|NCT00727194|143097588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.58||||0.1873|TWO_SIDED|95.0|-4.08|0.91||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||||0.91|-4.08|0.1873
71798822|NCT00727194|143097588|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.57||||0.041|TWO_SIDED|95.0|-6.97|-0.17||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||||-0.17|-6.97|0.0410
71798823|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.83||||0.919|TWO_SIDED|95.0|-16.94|18.6||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Physical Functioning||18.60|-16.94|0.9190
71798824|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.86||||0.5931|TWO_SIDED|95.0|-39.05|23.33||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Functioning||23.33|-39.05|0.5931
71798825|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|3.13||||0.7319|TWO_SIDED|95.0|-16.64|22.89||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Role Physical||22.89|-16.64|0.7319
71798826|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-7.14||||0.691|TWO_SIDED|95.0|-45.36|31.08||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Physical||31.08|-45.36|0.6910
71798827|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-9.42||||0.1311|TWO_SIDED|95.0|-22.18|3.34||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Bodily Pain||3.34|-22.18|0.1311
71798828|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-14.86||||0.2406|TWO_SIDED|95.0|-41.08|11.36||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Bodily Pain||11.36|-41.08|0.2406
71798829|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.17||||0.0578|TWO_SIDED|95.0|-0.29|14.62||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||General Health||14.62|-0.29|0.0578
71798830|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.43||||0.5073|TWO_SIDED|95.0|-16.26|31.11||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||General Health||31.11|-16.26|0.5073
71798831|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.17||||0.2474|TWO_SIDED|95.0|-3.39|11.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Vitality||11.72|-3.39|0.2474
71798832|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.68||||0.8085|TWO_SIDED|95.0|-26.24|20.88||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Vitality||20.88|-26.24|0.8085
71674606|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.2018|TWO_SIDED|90.0|-1.13|0.37|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.13|0.2018
71674607|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43||0.3925|TWO_SIDED|90.0|-0.83|0.59|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.59|-0.83|0.3925
71674608|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.42||0.5348|TWO_SIDED|90.0|-0.66|0.73|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.73|-0.66|0.5348
71674609|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.43||0.0739|TWO_SIDED|90.0|-1.33|0.09|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.09|-1.33|0.0739
71674610|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.44||0.4014|TWO_SIDED|90.0|-0.84|0.62|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.62|-0.84|0.4014
71674611|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6588|TWO_SIDED|90.0|-0.56|0.93|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.93|-0.56|0.6588
71798833|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.46||||0.0716|TWO_SIDED|95.0|-24.13|1.21||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Social Functioning||1.21|-24.13|0.0716
71798834|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-16.07||||0.1966|TWO_SIDED|95.0|-41.68|9.54||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Social Functioning||9.54|-41.68|0.1966
71798835|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-11.81||||0.1701|TWO_SIDED|95.0|-29.6|5.99||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Role Emotional||5.99|-29.60|0.1701
71893452|NCT01614457|143308041|SUPERIORITY_OR_OTHER||LS Mean difference|-23.9693|||<|0.0001|TWO_SIDED|95.0|-28.0094|-19.9293|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and sweat chloride, using a compound symmetry covariance matrix.||-19.9293|-28.0094|<0.0001
71674612|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.2997|TWO_SIDED|90.0|-1.0|0.52|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.52|-1.00|0.2997
71798836|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.95||||0.7422|TWO_SIDED|95.0|-32.58|44.48||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Emotional||44.48|-32.58|0.7422
71674613|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2518|TWO_SIDED|90.0|-1.08|0.46|||MMRM|||Week 4:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.46|-1.08|0.2518
71674614|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.2634|TWO_SIDED|90.0|-1.0|0.45|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.00|0.2634
71674615|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.45||0.1999|TWO_SIDED|90.0|-1.11|0.36|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.36|-1.11|0.1999
71674616|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.44||0.1847|TWO_SIDED|90.0|-1.13|0.33|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.33|-1.13|0.1847
71674617|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4569|TWO_SIDED|90.0|-0.81|0.71|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.71|-0.81|0.4569
71798837|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.9007|TWO_SIDED|95.0|-6.83|7.67||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Health||7.67|-6.83|0.9007
71798838|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.86||||0.1519|TWO_SIDED|95.0|-7.57|43.29||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Health||43.29|-7.57|0.1519
71798839|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.07||||0.6807|TWO_SIDED|95.0|-4.57|6.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Physical Component Score||6.72|-4.57|0.6807
71798840|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.23||||0.2226|TWO_SIDED|95.0|-16.79|4.32||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Component Score||4.32|-16.79|0.2226
71798841|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.92||||0.1505|TWO_SIDED|95.0|-7.1|1.26||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Component Score||1.26|-7.10|0.1505
71840850|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.486|||<|0.0001|TWO_SIDED|95.0|-2.782|-2.19|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.190|-2.782|<.0001
71674618|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8536|TWO_SIDED|90.0|-0.27|1.22|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.22|-0.27|0.8536
71674619|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.4812|TWO_SIDED|90.0|-0.79|0.74|||MMRM|||Week 6:MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.74|-0.79|0.4812
71674620|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.2276|TWO_SIDED|90.0|-1.13|0.42|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.42|-1.13|0.2276
71798842|NCT00727194|143097589|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.55||||0.4151|TWO_SIDED|95.0|-8.77|19.87||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Component Score||19.87|-8.77|0.4151
71798843|NCT00727194|143097590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.25||||0.3377|TWO_SIDED|95.0|-3.94|10.44||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Forced Vital Capacity||10.44|-3.94|0.3377
71798844|NCT00727194|143097590|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Net)|-10.57||||0.3391|TWO_SIDED|95.0|-33.71|12.56||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Forced Vital Capacity||12.56|-33.71|0.3391
71798845|NCT00727194|143097590|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-4.35|4.35||No multiple comparisons or multiplicity adjustments were conducted.|paired t test|||Negative Inspiratory Force||4.35|-4.35|1.0000
71798846|NCT00727194|143097590|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.57||||0.2292|TWO_SIDED|95.0|-17.87|4.73||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Negative Inspiratory Force||4.73|-17.87|0.2292
71798847|NCT04269161|143097603|NON_INFERIORITY|The margin of non-inferiority is 10 seconds such that the device is no worse than 10 seconds on average than manual mode. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|-9.885||||0.003|TWO_SIDED|95.0|-16.51|-3.27||The p-value is significant at 0.01.|t-test, 2 sided||The difference is time to re-establish in automatic mode minus time to re-establish in manual mode. (a negative number favors automatic mode)|A sample requirement of 48 patients was determined based on a pilot study to provide 88% power, and 0.05 significance (two sided) to show the mean difference is less than 10 seconds based on a 2x2 crossover design. Considering patient drop-out, a sample size of n=40 drops power to 82%.||-3.27|-16.51|0.003
71798848|NCT04269161|143097604|OTHER|The difference is defined as the difference of proportion of time in the target range of SpO2 in modes, automatic minus manual. Our study is a 2-treatment, 24-period crossover design that accounts for first-order carryover effects, indicating a slightly higher power than a 2x2. Each subject acted as their own control. The study was defined as intention to treat, such that manual adjustments during the automated arm would be included in that arm.|Mean Difference (Net)|0.018||||0.02|TWO_SIDED|95.0|0.003|0.034||The threshold for statistical significance is p=.05|t-test, 2 sided|Two-sample t test with equal variances. Linear mixed model patient random effects, adjusted for site, sex, race, weight, gestational age, bed type.|Treatment difference = automatic - manual. A positive number favors automatic.|The difference in the proportion of time in the target saturation is calculated between the automatic and manual models. For each 6-hour time block, we calculate the proportion of time the patient stays within the prescribed SpO2 range.||.034|0.003|.02
71798849|NCT00494494|143097648|NON_INFERIORITY_OR_EQUIVALENCE|Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.|Mean Difference (Net)|2.82|STANDARD_DEVIATION|13.8||0.7029|TWO_SIDED|95.0|-3.27|8.91|||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.||8.91|-3.27|0.7029
71798850|NCT00494494|143097649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.01|STANDARD_DEVIATION|9.56||0.1937|TWO_SIDED|95.0|-2.41|6.43|||Wilcoxon (Mann-Whitney)|||||6.43|-2.41|0.1937
71674621|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.0895|TWO_SIDED|90.0|-1.34|0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.14|-1.34|0.0895
71674622|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.47||0.0411|TWO_SIDED|90.0|-1.58|-0.04|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.04|-1.58|0.0411
71674623|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.47||0.0928|TWO_SIDED|90.0|-1.4|0.15|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.15|-1.40|0.0928
71798851|NCT00494494|143097650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|19.6||0.5066|TWO_SIDED|95.0|-3.12|16.52|||Wilcoxon (Mann-Whitney)|||||16.52|-3.12|0.5066
71798852|NCT00494494|143097651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.21||0.5099|TWO_SIDED|95.0|-0.13|0.227|||Wilcoxon (Mann-Whitney)|||||0.227|-0.13|0.5099
71798853|NCT00494494|143097652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_DEVIATION|5.64||0.5005|TWO_SIDED|95.0|-1.49|3.55|||Wilcoxon (Mann-Whitney)|||||3.55|-1.49|0.5005
71798854|NCT02477020|143097661|SUPERIORITY_OR_OTHER||Least square mean difference|-5.46|STANDARD_ERROR_OF_MEAN|3.442||0.115|TWO_SIDED|95.0|-12.26|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM|MMRM||TAK-063 - Placebo. Baseline Positive and Negative Symptom Scale (PANSS) total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|||1.35|-12.26|0.115
71798855|NCT02477020|143097662|SUPERIORITY_OR_OTHER||Least square mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.508||0.602|TWO_SIDED|95.0|-3.77|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 1||2.19|-3.77|0.602
71798856|NCT02477020|143097662|SUPERIORITY_OR_OTHER||Least square mean difference|-2.22|STANDARD_ERROR_OF_MEAN|2.229||0.322|TWO_SIDED|95.0|-6.62|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 2||2.19|-6.62|0.322
71798857|NCT02477020|143097662|SUPERIORITY_OR_OTHER||Least square mean difference|-3.46|STANDARD_ERROR_OF_MEAN|2.813||0.221|TWO_SIDED|95.0|-9.02|2.1||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 3||2.10|-9.02|0.221
71798858|NCT02477020|143097662|SUPERIORITY_OR_OTHER||Least square mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.147||0.504|TWO_SIDED|95.0|-8.33|4.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 4||4.11|-8.33|0.504
71798859|NCT02477020|143097662|SUPERIORITY_OR_OTHER||Least square mean difference|-3.91|STANDARD_ERROR_OF_MEAN|3.231||0.229|TWO_SIDED|95.0|-10.3|2.48||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 5||2.48|-10.30|0.229
71798860|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.562||0.195|TWO_SIDED|95.0|-1.84|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 1||0.38|-1.84|0.195
71798861|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.786||0.132|TWO_SIDED|95.0|-2.74|0.36||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 2||0.36|-2.74|0.132
71798862|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-1.94|STANDARD_ERROR_OF_MEAN|0.959||0.045|TWO_SIDED|95.0|-3.84|-0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 3||-0.05|-3.84|0.045
71798863|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-1.54|STANDARD_ERROR_OF_MEAN|1.025||0.135|TWO_SIDED|95.0|-3.56|0.49||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 4||0.49|-3.56|0.135
71893453|NCT01614457|143308042|SUPERIORITY_OR_OTHER||LS Mean difference|8.3874||||0.0091|TWO_SIDED|95.0|2.1658|14.609|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and CFQ-R respiratory domain score, using compound symmetry covariance matrix.||14.6090|2.1658|0.0091
71893454|NCT01614457|143308043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.8556|TWO_SIDED||||||Cox Proportional Hazard Regression|||||||0.8556
71674624|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.49||0.0799|TWO_SIDED|90.0|-1.48|0.12|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.12|-1.48|0.0799
71674625|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.46||0.7872|TWO_SIDED|90.0|-0.39|1.11|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||1.11|-0.39|0.7872
71674626|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6294|TWO_SIDED|90.0|-0.61|0.92|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.92|-0.61|0.6294
71674627|NCT03850483|142867382|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.48||0.5174|TWO_SIDED|90.0|-0.76|0.8|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.80|-0.76|0.5174
71674628|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3136|TWO_SIDED|90.0|-0.98|0.53|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-0.98|0.3136
71674629|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.102|TWO_SIDED|90.0|-1.42|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.42|0.1020
71840851|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.668|-2.233|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-2.233|-2.668|<.0001
71674630|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.1923|TWO_SIDED|90.0|-1.2|0.37|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.37|-1.20|0.1923
71674631|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.0997|TWO_SIDED|90.0|-1.44|0.18|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.18|-1.44|0.0997
71674632|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2497|TWO_SIDED|90.0|-1.08|0.45|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.45|-1.08|0.2497
71674633|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.2568|TWO_SIDED|90.0|-1.08|0.47|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.47|-1.08|0.2568
71674634|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.48||0.373|TWO_SIDED|90.0|-0.95|0.64|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.64|-0.95|0.3730
71674635|NCT03850483|142867382|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46||0.0137|TWO_SIDED|90.0|-1.76|-0.26|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.26|-1.76|0.0137
71674636|NCT03850483|142867382|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0055|TWO_SIDED|90.0|-2.06|-0.44|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.44|-2.06|0.0055
71674637|NCT03850483|142867382|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.48||0.0069|TWO_SIDED|90.0|-1.99|-0.4|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.40|-1.99|0.0069
71674638|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.1648|TWO_SIDED|90.0|-1.34|0.34|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.34|-1.34|0.1648
71674639|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.2931|TWO_SIDED|90.0|-1.02|0.51|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.51|-1.02|0.2931
71674640|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.47||0.3047|TWO_SIDED|90.0|-1.01|0.53|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.53|-1.01|0.3047
71674641|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.1924|TWO_SIDED|90.0|-1.22|0.38|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.38|-1.22|0.1924
71674642|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.46||0.0465|TWO_SIDED|90.0|-1.52|-0.02|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.02|-1.52|0.0465
71674643|NCT03850483|142867382|SUPERIORITY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.49||0.0048|TWO_SIDED|90.0|-2.08|-0.47|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.47|-2.08|0.0048
71674644|NCT03850483|142867382|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0186|TWO_SIDED|90.0|-1.78|-0.21|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||-0.21|-1.78|0.0186
71798864|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.09||0.067|TWO_SIDED|95.0|-4.17|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 5||0.14|-4.17|0.067
71798865|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|1.119||0.092|TWO_SIDED|95.0|-4.11|0.31||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 6||0.31|-4.11|0.092
71798866|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.566||0.548|TWO_SIDED|95.0|-0.78|1.46||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 1||1.46|-0.78|0.548
71798867|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.756||0.42|TWO_SIDED|95.0|-2.11|0.88||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 2||0.88|-2.11|0.420
71798868|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.818||0.857|TWO_SIDED|95.0|-1.47|1.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 3||1.76|-1.47|0.857
71840852|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.466||||0.0012|TWO_SIDED|95.0|0.185|0.747|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.747|0.185|0.0012
71840853|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.099||||0.4957|TWO_SIDED|95.0|-0.187|0.386|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.386|-0.187|0.4957
71896285|NCT03114969|143314782|SUPERIORITY||Odds Ratio (OR)|2.409||||0.122|TWO_SIDED|95.0|0.792|7.331||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.331|0.792|0.122
71674645|NCT03850483|142867382|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.51||0.0675|TWO_SIDED|90.0|-1.61|0.08|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Compound symmetry covariance matrix was used for model errors.||0.08|-1.61|0.0675
71674646|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.3232|TWO_SIDED|90.0|-0.69|0.39|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.39|-0.69|0.3232
71674647|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.33||0.0736|TWO_SIDED|90.0|-1.03|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.03|0.0736
71674648|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.35||0.0743|TWO_SIDED|90.0|-1.07|0.07|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.07|0.0743
71840854|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.753|||<|0.0001|TWO_SIDED|95.0|-3.266|-2.239|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.239|-3.266|<.0001
71840855|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.514|||<|0.0001|TWO_SIDED|95.0|-3.043|-1.986|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-1.986|-3.043|<.0001
71840856|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-2.848|||<|0.0001|TWO_SIDED|95.0|-3.359|-2.336|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-2.336|-3.359|<.0001
71840857|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.105|-2.066|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.066|-3.105|<.0001
71840858|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.55|||<|0.0001|TWO_SIDED|95.0|-2.901|-2.199|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.199|-2.901|<.0001
71840859|NCT04800211|143190997|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.071||||0.7372|TWO_SIDED|95.0|-0.346|0.489|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.489|-0.346|0.7372
71896286|NCT03114969|143314783|SUPERIORITY||Odds Ratio (OR)|4.887||||0.001|TWO_SIDED|95.0|1.851|12.903||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||12.903|1.851|0.001
71896287|NCT03114969|143314783|SUPERIORITY||Odds Ratio (OR)|5.484|||<|0.001|TWO_SIDED|95.0|2.106|14.284||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||14.284|2.106|<0.001
71674649|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.32||0.0641|TWO_SIDED|90.0|-1.03|0.04|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.04|-1.03|0.0641
71674650|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3887|TWO_SIDED|90.0|-0.71|0.5|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.50|-0.71|0.3887
71674651|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.37||0.0767|TWO_SIDED|90.0|-1.15|0.08|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.08|-1.15|0.0767
71798869|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.936||0.527|TWO_SIDED|95.0|-2.44|1.26||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 4||1.26|-2.44|0.527
71798870|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.94||0.875|TWO_SIDED|95.0|-2.01|1.71||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 5||1.71|-2.01|0.875
71798871|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.94||0.441|TWO_SIDED|95.0|-2.58|1.13||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 6||1.13|-2.58|0.441
71798872|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.406||0.362|TWO_SIDED|95.0|-1.17|0.43||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 1||0.43|-1.17|0.362
71798873|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.53||0.687|TWO_SIDED|95.0|-1.26|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 2||0.83|-1.26|0.687
71798874|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.618||0.458|TWO_SIDED|95.0|-1.68|0.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 3||0.76|-1.68|0.458
71798875|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.704||0.991|TWO_SIDED|95.0|-1.38|1.4||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 4||1.40|-1.38|0.991
71798876|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.782||0.354|TWO_SIDED|95.0|-2.27|0.82||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 5||0.82|-2.27|0.354
71798877|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.804||0.119|TWO_SIDED|95.0|-2.85|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 6||0.33|-2.85|0.119
71798878|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.469||0.493|TWO_SIDED|95.0|-1.25|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 1||0.60|-1.25|0.493
71798879|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.504||0.949|TWO_SIDED|95.0|-0.96|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 2||1.03|-0.96|0.949
71896288|NCT03114969|143314784|SUPERIORITY||Odds Ratio (OR)|3.941|||<|0.001|TWO_SIDED|95.0|1.863|8.337||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||8.337|1.863|<0.001
71674652|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.38||0.2529|TWO_SIDED|90.0|-0.89|0.38|||MMRM|||Week 1: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.38|-0.89|0.2529
71674653|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5304|TWO_SIDED|90.0|-0.61|0.67|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-0.61|0.5304
71840860|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.106|||<|0.0001|TWO_SIDED|95.0|-3.502|-2.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.710|-3.502|<.0001
71840861|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.824|||<|0.0001|TWO_SIDED|95.0|-3.235|-2.414|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.414|-3.235|<.0001
71840862|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.228|||<|0.0001|TWO_SIDED|95.0|-3.553|-2.904|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.904|-3.553|<.0001
71840863|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.839|||<|0.0001|TWO_SIDED|95.0|-3.221|-2.457|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.457|-3.221|<.0001
71896289|NCT03114969|143314784|SUPERIORITY||Odds Ratio (OR)|2.391||||0.03|TWO_SIDED|95.0|1.088|5.256||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.256|1.088|0.030
71896290|NCT03114969|143314784|SUPERIORITY||Odds Ratio (OR)|4.728|||<|0.001|TWO_SIDED|95.0|2.388|9.364||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.364|2.388|<0.001
71798880|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.604||0.153|TWO_SIDED|95.0|-2.06|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 3||0.33|-2.06|0.153
71798881|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.681||0.994|TWO_SIDED|95.0|-1.34|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 4||1.35|-1.34|0.994
71674654|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.292|TWO_SIDED|90.0|-0.87|0.43|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.43|-0.87|0.2920
71674655|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41||0.2593|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.2593
71674656|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.38||0.431|TWO_SIDED|90.0|-0.7|0.57|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-0.70|0.4310
71674657|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.5477|TWO_SIDED|90.0|-0.59|0.69|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.69|-0.59|0.5477
71674658|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.39||0.0696|TWO_SIDED|90.0|-1.24|0.07|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.07|-1.24|0.0696
71674659|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41||0.3583|TWO_SIDED|90.0|-0.82|0.53|||MMRM|||Week 2: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-0.82|0.3583
71674660|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.6826|TWO_SIDED|90.0|-0.56|1.01|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.01|-0.56|0.6826
71674661|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.457|TWO_SIDED|90.0|-0.84|0.74|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.74|-0.84|0.4570
71798882|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.679||0.365|TWO_SIDED|95.0|-1.96|0.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 5||0.73|-1.96|0.365
71674662|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.49||0.3265|TWO_SIDED|90.0|-1.03|0.59|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.59|-1.03|0.3265
71674663|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.3039|TWO_SIDED|90.0|-1.0|0.53|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.53|-1.00|0.3039
71674664|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2086|TWO_SIDED|90.0|-1.23|0.42|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.42|-1.23|0.2086
71674665|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.5||0.2172|TWO_SIDED|90.0|-1.22|0.44|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.44|-1.22|0.2172
71798883|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.653||0.088|TWO_SIDED|95.0|-2.41|0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 6||0.17|-2.41|0.088
71896291|NCT03114969|143314784|SUPERIORITY||Odds Ratio (OR)|2.957||||0.002|TWO_SIDED|95.0|1.473|5.936||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.936|1.473|0.002
71674666|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.2855|TWO_SIDED|90.0|-1.16|0.57|||MMRM|||Week 4: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.57|-1.16|0.2855
71674667|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.8372|TWO_SIDED|90.0|-0.34|1.36|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.36|-0.34|0.8372
71674668|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.52||0.4792|TWO_SIDED|90.0|-0.89|0.84|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.84|-0.89|0.4792
71674669|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3331|TWO_SIDED|90.0|-1.12|0.65|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.65|-1.12|0.3331
71674670|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.108|TWO_SIDED|90.0|-1.47|0.21|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.21|-1.47|0.1080
71674671|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.48||0.0455|TWO_SIDED|90.0|-1.61|-0.02|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-1.61|0.0455
71674672|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.48||0.0761|TWO_SIDED|90.0|-1.49|0.1|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.10|-1.49|0.0761
71798884|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.397||0.535|TWO_SIDED|95.0|-0.54|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 1||1.03|-0.54|0.535
71798885|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.502||0.412|TWO_SIDED|95.0|-1.4|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 2||0.58|-1.40|0.412
71798886|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.522||0.354|TWO_SIDED|95.0|-1.52|0.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 3||0.55|-1.52|0.354
71840864|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-2.449|||<|0.0001|TWO_SIDED|95.0|-2.828|-2.07|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.070|-2.828|<.0001
71840865|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.023|||<|0.0001|TWO_SIDED|95.0|-3.328|-2.718|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.718|-3.328|<.0001
71840866|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.126|||<|0.0001|TWO_SIDED|95.0|-3.354|-2.897|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.897|-3.354|<.0001
71674673|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0273|TWO_SIDED|90.0|-1.8|-0.14|||MMRM|||Week 6: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.14|-1.80|0.0273
71798887|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.59||0.589|TWO_SIDED|95.0|-1.49|0.85||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 4||0.85|-1.49|0.589
71896292|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|2.404||||0.045|TWO_SIDED|95.0|1.018|5.676||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||5.676|1.018|0.045
71674674|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.54||0.7214|TWO_SIDED|90.0|-0.57|1.2|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.20|-0.57|0.7214
71674675|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6132|TWO_SIDED|90.0|-0.75|1.06|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.06|-0.75|0.6132
71674676|NCT03850483|142867384|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.5704|TWO_SIDED|90.0|-0.83|1.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||1.02|-0.83|0.5704
71674677|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.53||0.3449|TWO_SIDED|90.0|-1.1|0.67|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.67|-1.10|0.3449
71798888|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.569||0.36|TWO_SIDED|95.0|-1.65|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 5||0.60|-1.65|0.360
71798889|NCT02477020|143097663|SUPERIORITY_OR_OTHER||Least square mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.635||0.288|TWO_SIDED|95.0|-1.93|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 6||0.58|-1.93|0.288
71798890|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.59||0.238|TWO_SIDED|95.0|-1.87|0.47||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 1||0.47|-1.87|0.238
71798891|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.784||0.359|TWO_SIDED|95.0|-2.27|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 2||0.83|-2.27|0.359
71798892|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.943||0.119|TWO_SIDED|95.0|-3.34|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 3||0.38|-3.34|0.119
71798893|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.014||0.238|TWO_SIDED|95.0|-3.21|0.8||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 4||0.80|-3.21|0.238
71840867|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.908|||<|0.0001|TWO_SIDED|95.0|0.518|1.298|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.298|0.518|<.0001
71896293|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|1.823||||0.172|TWO_SIDED|95.0|0.77|4.319||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.319|0.770|0.172
71896294|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|2.989||||0.016|TWO_SIDED|95.0|1.229|7.272||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||7.272|1.229|0.016
71896295|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|1.747||||0.179|TWO_SIDED|95.0|0.775|3.937||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||3.937|0.775|0.179
71674678|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.58||0.0493|TWO_SIDED|90.0|-1.94|0.0|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.00|-1.94|0.0493
71798894|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.73|STANDARD_ERROR_OF_MEAN|1.051||0.102|TWO_SIDED|95.0|-3.81|0.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 5||0.35|-3.81|0.102
71674679|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.149|TWO_SIDED|90.0|-1.55|0.35|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.35|-1.55|0.1490
71674680|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.054|TWO_SIDED|90.0|-1.96|0.02|||MMRM|||Week 8: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.02|-1.96|0.0540
71674681|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.3119|TWO_SIDED|90.0|-1.32|0.71|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.71|-1.32|0.3119
71798895|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.094||0.145|TWO_SIDED|95.0|-3.77|0.56||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 6||0.56|-3.77|0.145
71798896|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.504||0.902|TWO_SIDED|95.0|-0.93|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 1||1.06|-0.93|0.902
71798897|NCT02477020|143097664|SUPERIORITY_OR_OTHER||MMRM|-0.59|STANDARD_ERROR_OF_MEAN|0.693||0.396|TWO_SIDED|95.0|-1.96|0.78||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 2||0.78|-1.96|0.396
71798898|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.722||0.612|TWO_SIDED|95.0|-1.79|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 3||1.06|-1.79|0.612
71798899|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.856||0.67|TWO_SIDED|95.0|-2.06|1.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 4||1.33|-2.06|0.670
71798900|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.892||0.807|TWO_SIDED|95.0|-1.98|1.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 5||1.55|-1.98|0.807
71798901|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.14|STANDARD_ERROR_OF_MEAN|0.853||0.182|TWO_SIDED|95.0|-2.83|0.54||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 6||0.54|-2.83|0.182
71798902|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.801||0.933|TWO_SIDED|95.0|-1.52|1.65||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 1||1.65|-1.52|0.933
71798903|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.61|STANDARD_ERROR_OF_MEAN|1.151||0.596|TWO_SIDED|95.0|-2.89|1.66||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 2||1.66|-2.89|0.596
71798904|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.31|STANDARD_ERROR_OF_MEAN|1.455||0.371|TWO_SIDED|95.0|-4.18|1.57||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 3||1.57|-4.18|0.371
71896296|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|1.189||||0.69|TWO_SIDED|95.0|0.509|2.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.775|0.509|0.690
71674682|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.3947|TWO_SIDED|90.0|-1.2|0.86|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.86|-1.20|0.3947
71674683|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.4205|TWO_SIDED|90.0|-1.18|0.93|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.93|-1.18|0.4205
71798905|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|1.625||0.821|TWO_SIDED|95.0|-3.58|2.84||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 4||2.84|-3.58|0.821
71798906|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-1.61|STANDARD_ERROR_OF_MEAN|1.621||0.323|TWO_SIDED|95.0|-4.81|1.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 5||1.60|-4.81|0.323
71798907|NCT02477020|143097664|SUPERIORITY_OR_OTHER||Least square mean difference|-2.44|STANDARD_ERROR_OF_MEAN|1.732||0.161|TWO_SIDED|95.0|-5.87|0.98||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 6||0.98|-5.87|0.161
71798908|NCT02477020|143097665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.664||||0.017|TWO_SIDED|95.0|1.263|10.624|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 1||10.624|1.263|0.017
71798909|NCT02477020|143097665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.782||||0.009|TWO_SIDED|95.0|1.287|6.014|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 2||6.014|1.287|0.009
71798910|NCT02477020|143097665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.818||||0.108|TWO_SIDED|95.0|0.877|3.771|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 3||3.771|0.877|0.108
71798911|NCT02477020|143097665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.222||||0.596|TWO_SIDED|95.0|0.583|2.561|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 4||2.561|0.583|0.596
71798912|NCT02477020|143097665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.542||||0.263|TWO_SIDED|95.0|0.722|3.292|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 5||3.292|0.722|0.263
71798913|NCT02477020|143097665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.253||95.0|0.725|3.388|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 6||3.388|0.725|0.253
71798914|NCT02477020|143097666|SUPERIORITY_OR_OTHER||Least square mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.095||0.619|TWO_SIDED|95.0|-0.23|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 1||0.14|-0.23|0.619
71798915|NCT02477020|143097666|SUPERIORITY_OR_OTHER||Least square mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.136||0.116|TWO_SIDED|95.0|-0.48|0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 2||0.05|-0.48|0.116
71798916|NCT02477020|143097666|SUPERIORITY_OR_OTHER||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.166||0.009|TWO_SIDED|95.0|-0.77|-0.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 3||-0.11|-0.77|0.009
71798917|NCT02477020|143097666|SUPERIORITY_OR_OTHER||Least square mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.049|TWO_SIDED|95.0|-0.72|0.0||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 4||0.00|-0.72|0.049
71798918|NCT02477020|143097666|SUPERIORITY_OR_OTHER||Least square mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.191||0.016|TWO_SIDED|95.0|-0.85|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 5||-0.09|-0.85|0.016
71798919|NCT02477020|143097666|SUPERIORITY_OR_OTHER||Least square mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.202||0.035||95.0|-0.83|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 6||-0.03|-0.83|0.035
71798920|NCT02477020|143097667|SUPERIORITY_OR_OTHER||Least square mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.128||0.746|TWO_SIDED|95.0|-0.29|0.21||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 1||0.21|-0.29|0.746
71798921|NCT02477020|143097667|SUPERIORITY_OR_OTHER||Least mean square difference|-0.37|STANDARD_ERROR_OF_MEAN|0.173||0.034|TWO_SIDED|95.0|-0.72|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 2||-0.03|-0.72|0.034
71798922|NCT02477020|143097667|SUPERIORITY_OR_OTHER||Least square mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.203||0.006|TWO_SIDED|95.0|-0.97|-0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 3||-0.17|-0.97|0.006
71798923|NCT02477020|143097667|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.22||0.013|TWO_SIDED|95.0|-0.99|-0.12||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 4||-0.12|-0.99|0.013
71798924|NCT02477020|143097667|SUPERIORITY_OR_OTHER||Least mean square difference|-0.56|STANDARD_ERROR_OF_MEAN|0.238||0.02|TWO_SIDED|95.0|-1.03|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 5||-0.09|-1.03|0.020
71798925|NCT02477020|143097667|SUPERIORITY_OR_OTHER||Least square mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.244||0.007|TWO_SIDED|95.0|-1.15|-0.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 6||-0.18|-1.15|0.007
71840868|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|1.291|||<|0.0001|TWO_SIDED|95.0|0.902|1.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||1.679|0.902|<.0001
71840869|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|0.174||||0.2772|TWO_SIDED|95.0|-0.142|0.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.490|-0.142|0.2772
71840870|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.014|||<|0.0001|TWO_SIDED|95.0|-4.75|-3.278|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.278|-4.750|<.0001
71896297|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|3.363||||0.004|TWO_SIDED|95.0|1.48|7.639||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||7.639|1.480|0.004
71798926|NCT02477020|143097668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.077|TWO_SIDED|95.0|0.899|8.267||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 1||8.267|0.899|0.077
71896298|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|2.848||||0.012|TWO_SIDED|95.0|1.264|6.42||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||6.420|1.264|0.012
71798927|NCT02477020|143097668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.331||||0.036|TWO_SIDED|95.0|1.055|5.153||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 2||5.153|1.055|0.036
71798928|NCT02477020|143097668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.015|TWO_SIDED|95.0|1.208|5.99||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 3||5.990|1.208|0.015
71798929|NCT02477020|143097668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.737||||0.158|TWO_SIDED|95.0|0.807|3.735||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 4||3.735|0.807|0.158
71798930|NCT02477020|143097668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739||||0.164|TWO_SIDED|95.0|0.798|3.789||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 5||3.789|0.798|0.164
71798931|NCT02477020|143097668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44||||0.003|TWO_SIDED|95.0|1.523|7.77||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 6||7.770|1.523|0.003
71798932|NCT02477020|143097669|SUPERIORITY_OR_OTHER||Least square mean difference|1.8|STANDARD_ERROR_OF_MEAN|1.547||0.246|TWO_SIDED|95.0|-1.26|4.86||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 3||4.86|-1.26|0.246
71798933|NCT02477020|143097669|SUPERIORITY_OR_OTHER||Least square mean difference|2.2|STANDARD_ERROR_OF_MEAN|1.767||0.216|TWO_SIDED|95.0|-1.3|5.69||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|Least square mean difference||TAK-063 - Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction|Change at Week 6||5.69|-1.30|0.216
71798934|NCT02477020|143097670|SUPERIORITY_OR_OTHER||Least mean square difference|-0.38|STANDARD_ERROR_OF_MEAN|1.664||0.82|TWO_SIDED|95.0|-3.67|2.91||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BNSS total score-by-week interaction.|Change at Week 3||2.91|-3.67|0.820
71798935|NCT02477020|143097670|SUPERIORITY_OR_OTHER||Least square mean difference|-2.87|STANDARD_ERROR_OF_MEAN|2.05||0.163|TWO_SIDED|95.0|-6.93|1.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 6||1.18|-6.93|0.163
71798936|NCT02477020|143097671|SUPERIORITY_OR_OTHER||Least square mean difference|2.69|STANDARD_ERROR_OF_MEAN|1.769||0.131|TWO_SIDED|95.0|-0.81|6.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 3||6.19|-0.81|0.131
71798937|NCT02477020|143097671|SUPERIORITY_OR_OTHER||Least square mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.313||0.26|TWO_SIDED|95.0|-1.96|7.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 6||7.19|-1.96|0.260
71798938|NCT02477020|143097672|SUPERIORITY_OR_OTHER||Least square mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.855||0.973|TWO_SIDED|95.0|-3.61|3.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 3||3.73|-3.61|0.973
71798939|NCT02477020|143097672|SUPERIORITY_OR_OTHER||Least mean square difference|-0.54|STANDARD_ERROR_OF_MEAN|2.255||0.812|TWO_SIDED|95.0|-5.0|3.92||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 - Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 6||3.92|-5.00|0.812
71798940|NCT02099721|143097696|EQUIVALENCE|The equivalence margin is a hazard ratio significantly above 0.70.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.38|0.57|||||The hazard ratio, estimated by a Cox proportional hazard model, has time to first treated VT/VF for 1.5 Prevention in the numerator, with Secondary Prevention in the denominator.|"H0: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) ≤ 0.70~HA: Hazard ratio of Implanted 1.5 patients (Group C) to implanted secondary patients (Group A) \> 0.70"||0.57|0.38|
71798941|NCT02099721|143097697|SUPERIORITY|A hazard ratio significantly below 1 indicates reduced mortality in the 1.5 implanted group.|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.4|0.66||The p-value is for the effect of treatment group on time to death, adjusting for the baseline covariates of age, gender, QRS duration, ischemic cardiomyopathy, LBBB, NYHA classification, diabetes, LVEF, syncope, NSVT and PVCs.|Wald chi-square||Multiple imputations were employed to account for missing baseline covariates.|The null hypothesis is that the hazard ratio of implanted to non-implanted 1.5 patients = 1. The alternative is that the ratio is not equal to 1.||0.66|0.40|< 0.0001
71896299|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|4.63|||<|0.001|TWO_SIDED|95.0|1.986|10.791||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||10.791|1.986|<0.001
71674684|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.0472|TWO_SIDED|90.0|-2.02|-0.02|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.02|-2.02|0.0472
71798942|NCT02566759|143097702|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.6662|||||TWO_SIDED|90.0|0.5969|0.7355||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.7355|0.5969|
71798943|NCT02566759|143097702|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.7795|||||TWO_SIDED|90.0|0.6597|0.8993|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.8993|0.6597|
71798944|NCT02566759|143097702|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) Mean Ratio|0.362|||||TWO_SIDED|90.0|0.3043|0.4301||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.||0.4301|0.3043|
71798945|NCT02566759|143097702|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|1.799|||||TWO_SIDED|90.0|1.4625|2.2116||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.2116|1.4625|
71798946|NCT02566759|143097705|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.872|||||TWO_SIDED|90.0|0.8145|0.9296||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9296|0.8145|
71798947|NCT02566759|143097705|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.9135|||||TWO_SIDED|90.0|0.8062|1.0209|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||1.0209|0.8062|
71798948|NCT02566759|143097705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.5|||||TWO_SIDED|90.0|0.4324|0.5777||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.5777|0.4324|
71798949|NCT02566759|143097705|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.563|||||TWO_SIDED|90.0|2.1|3.1275||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||3.1275|2.1000|
71798950|NCT02566759|143097706|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8505|||<|0.001|TWO_SIDED|90.0|0.7925|0.9084|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.||0.9084|0.7925|<0.001
71798951|NCT02566759|143097706|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.8415|||<|0.001|TWO_SIDED|90.0|0.7618|0.9212|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b\*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.||0.9212|0.7618|<0.001
71798952|NCT02566759|143097706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|0.543|||||TWO_SIDED|90.0|0.4797|0.6149||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||0.6149|0.4797|
71798953|NCT02566759|143097706|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Ratio|2.336|||||TWO_SIDED|90.0|1.9592|2.7854||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.||2.7854|1.9592|
71840871|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-4.115|||<|0.0001|TWO_SIDED|95.0|-4.865|-3.365|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.365|-4.865|<.0001
71798954|NCT01126541|143097709|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided).||||||0.465|||||||Wilcoxon (Mann-Whitney)|||Change from Day 1 to Week 24 (initial treatment)||||0.465
71798955|NCT01126541|143097709|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Arm A vs. Arm B: Change from 1st retreatment to 24 weeks after||||0.161
71798956|NCT01126541|143097709|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.524|||||||Student t-test|||Arm A vs. Arm B: Change from 2nd retreatment to 24 weeks after||||0.524
71798957|NCT01126541|143097710|NON_INFERIORITY_OR_EQUIVALENCE|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean plus or minus (±)SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B - Arm A \>20%. H1: Arm B - Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)|Adjusted difference|51.38|STANDARD_DEVIATION|92.0|||TWO_SIDED|95.0|-131.22|233.98|||||Covariate analysis with baseline DAS28-CRP value as covariate|||233.98|-131.22|
71798958|NCT01126541|143097730|SUPERIORITY_OR_OTHER|||||||0.389|||||||Wilcoxon (Mann-Whitney)|||Day 1 to Week 104||||0.389
71798959|NCT01126541|143097730|SUPERIORITY_OR_OTHER|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||1st retreatment to Week 104||||0.374
71798960|NCT01126541|143097730|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Weel 24 to Week 104||||0.277
71798961|NCT01126541|143097731|SUPERIORITY_OR_OTHER|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||Total cortisone: Week 24 to Week 104||||0.278
71798962|NCT01126541|143097731|SUPERIORITY_OR_OTHER|||||||0.887|||||||Wilcoxon (Mann-Whitney)|||Oral cortisone: Week 24 to Week 104||||0.887
71798963|NCT01126541|143097731|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||IV cortisone: Week 24 to Week 104||||<0.001
71798964|NCT03670810|143097766|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.001|TWO_SIDED|95.0|2.56|5.73|||Regression, Logistic|||||5.73|2.56|<0.001
71798965|NCT03670810|143097766|SUPERIORITY||Odds Ratio (OR)|4.56|||<|0.001|TWO_SIDED|95.0|3.07|6.77|||Regression, Logistic|||||6.77|3.07|<0.001
71798966|NCT03670810|143097767|SUPERIORITY||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.1|6.76|||Regression, Logistic|||||6.76|2.10|<.001
71798967|NCT03670810|143097767|SUPERIORITY||Odds Ratio (OR)|7.24|||<|0.001|TWO_SIDED|95.0|4.13|12.67|||Regression, Logistic|||||12.67|4.13|<.001
71798968|NCT03670810|143097768|SUPERIORITY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|2.05|3.57|||Regression, Logistic|||||3.57|2.05|<0.001
71798969|NCT03670810|143097768|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.001|TWO_SIDED|95.0|2.04|3.53|||Regression, Logistic|||||3.53|2.04|<0.001
71798970|NCT03670810|143097769|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|2.11|4.01|||Regression, Logistic|||||4.01|2.11|<0.001
71674685|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.59||0.0044|TWO_SIDED|90.0|-2.55|-0.6|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.60|-2.55|0.0044
71798971|NCT03670810|143097769|SUPERIORITY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.53|4.85|||Regression, Logistic|||||4.85|2.53|<0.001
71798972|NCT03670810|143097770|SUPERIORITY||Odds Ratio (OR)|3.52|||<|0.001|TWO_SIDED|95.0|2.05|6.02|||Regression, Logistic|||||6.02|2.05|<0.001
71798973|NCT03670810|143097770|SUPERIORITY||Odds Ratio (OR)|4.67|||<|0.001|TWO_SIDED|95.0|2.77|7.88|||Regression, Logistic|||||7.88|2.77|<0.001
71798974|NCT03670810|143097771|SUPERIORITY||Odds Ratio (OR)|2.3||||0.004|TWO_SIDED|95.0|1.3|4.04|||Regression, Logistic|||||4.04|1.30|0.004
71798975|NCT03670810|143097771|SUPERIORITY||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.41|6.94|||Regression, Logistic|||||6.94|2.41|<0.001
71798976|NCT03670810|143097772|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|1.8|6.02|||Regression, Logistic|||||6.02|1.80|<0.001
71798977|NCT03670810|143097772|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|1.97|6.42|||Regression, Logistic|||||6.42|1.97|<0.001
71798978|NCT03670810|143097773|SUPERIORITY||Odds Ratio (OR)|2.22|||<|0.001|TWO_SIDED|95.0|1.48|3.33|||Regression, Logistic|||||3.33|1.48|<0.001
71798979|NCT03670810|143097773|SUPERIORITY||Odds Ratio (OR)|2.46|||<|0.001|TWO_SIDED|95.0|1.65|3.67|||Regression, Logistic|||||3.67|1.65|<0.001
71798980|NCT03670810|143097774|SUPERIORITY||Odds Ratio (OR)|2.73||||0.031|TWO_SIDED|95.0|1.1|6.78|||Regression, Logistic|||||6.78|1.10|0.031
71798981|NCT03670810|143097774|SUPERIORITY||Odds Ratio (OR)|5.64|||<|0.001|TWO_SIDED|95.0|2.4|13.25|||Regression, Logistic|||||13.25|2.40|<0.001
71798982|NCT03670810|143097775|SUPERIORITY||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.29|2.35|||Regression, Logistic|||||2.35|1.29|<0.001
71798983|NCT03670810|143097775|SUPERIORITY||Odds Ratio (OR)|1.63||||0.001|TWO_SIDED|95.0|1.21|2.2|||Regression, Logistic|||||2.20|1.21|0.001
71798984|NCT03670810|143097776|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Regression, Logistic|||||0.65|0.33|<0.001
71798985|NCT03670810|143097776|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||||0.60|0.30|<0.001
71798986|NCT03670810|143097777|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.79|4.28|||Regression, Logistic|||||4.28|1.79|<0.001
71798987|NCT03670810|143097777|SUPERIORITY||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.2|5.15|||Regression, Logistic|||||5.15|2.20|<0.001
71798988|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|6.4||||0.086|TWO_SIDED|95.0|0.77|53.37|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||53.37|0.77|0.086
71798989|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|7.24||||0.065|TWO_SIDED|95.0|0.89|59.08|||Regression, Logistic|||Pain Freedom 30 Min. Postdose||59.08|0.89|0.065
71798990|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|3.08||||0.004|TWO_SIDED|95.0|1.42|6.68|||Regression, Logistic|||Pain Free 1 Hour Postdose||6.68|1.42|0.004
71798991|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|7.04|||<|0.001|TWO_SIDED|95.0|3.43|14.44|||Regression, Logistic|||Pain Free 1 Hour Postdose||14.44|3.43|<0.001
71798992|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|1.41||||0.065|TWO_SIDED|95.0|0.98|2.03|||Regression, Logistic|||Pain Relief 30 Min Postdose 100 mg||2.03|0.98|0.065
71798993|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|1.77||||0.001|TWO_SIDED|95.0|1.25|2.52|||Regression, Logistic|||Pain Relief 30 Min. Postdose 200 mg||2.52|1.25|0.001
71798994|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|2.31|||<|0.001|TWO_SIDED|95.0|1.74|3.06|||Regression, Logistic|||Pain Relief 1 Hour Postdose 100 mg||3.06|1.74|<0.001
71798995|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.64|2.88|||Regression, Logistic|||Pain Relief 1 Hour Postdose 200 mg||2.88|1.64|<0.001
71798996|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|1.11||||0.651|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic|||Freedom from MBS 30 Min 100 mg||1.71|0.71|0.651
71798997|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|1.3||||0.22|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Freedom from MBS 30 Min. 200 mg||1.98|0.85|0.220
71798998|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|1.1||||0.593|TWO_SIDED|95.0|0.78|1.54|||Regression, Logistic|||Freedom from MBS 1 Hour 100 mg||1.54|0.78|0.593
71798999|NCT03670810|143097779|SUPERIORITY||Odds Ratio (OR)|1.43||||0.03|TWO_SIDED|95.0|1.04|1.98|||Regression, Logistic|||Freedom from MBS 1 Hour 200 mg||1.98|1.04|0.030
71799000|NCT03670810|143097780|SUPERIORITY|||||||0.092|||||||ANCOVA|||||||0.092
71799001|NCT03670810|143097780|SUPERIORITY|||||||0.211|||||||ANCOVA|||||||0.211
71799002|NCT03670810|143097781|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.001|TWO_SIDED|95.0|2.01|4.05|||Regression, Logistic|||||4.05|2.01|<0.001
71799003|NCT03670810|143097781|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|2.12|4.26|||Regression, Logistic|||||4.26|2.12|<0.001
71799004|NCT03670810|143097782|SUPERIORITY|||||||0.056|||||||ANOVA|||Social Functioning||||0.056
71799005|NCT03670810|143097782|SUPERIORITY|||||||0.267|||||||ANOVA|||Social Functioning||||0.267
71799006|NCT03670810|143097782|SUPERIORITY|||||||0.003|||||||ANOVA|||Migraine Symptoms 100 mg||||0.003
71799007|NCT03670810|143097782|SUPERIORITY|||||||0.002|||||||ANOVA|||Migraine Symptoms 200 mg||||0.002
71799008|NCT03670810|143097782|SUPERIORITY|||||||0.014|||||||ANOVA|||Feeling/Concerns 100 mg||||0.014
71799009|NCT03670810|143097782|SUPERIORITY|||||||0.018|||||||ANOVA|||Feelings/Concerns 200 mg||||0.018
71799010|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|1.25||||0.101|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Recommend Treatment - Agree Strongly Agree||1.62|0.96|0.101
71799011|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|1.28||||0.063|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Recommend Treatment Agree/Strongly Agree||1.67|0.99|0.063
71799012|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|0.89||||0.376|TWO_SIDED|95.0|0.68|1.16|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.16|0.68|0.376
71799013|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|0.79||||0.082|TWO_SIDED|95.0|0.6|1.03|||Regression, Logistic|||Willing to Take This Treatment Again - Agree/Strongly Agree||1.03|0.60|0.082
71799014|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|1.25||||0.096|TWO_SIDED|95.0|0.96|1.62|||Regression, Logistic|||Extremely/Very Satisfied||1.62|0.96|0.096
71799015|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|1.38||||0.016|TWO_SIDED|95.0|1.06|1.8|||Regression, Logistic|||Extremely/Very Satisfied||1.80|1.06|0.016
71799016|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|1.12||||0.445|TWO_SIDED|95.0|0.84|1.49|||Regression, Logistic|||Prefer This Treatment||1.49|0.84|0.445
71799017|NCT03670810|143097783|SUPERIORITY||Odds Ratio (OR)|1.19||||0.243|TWO_SIDED|95.0|0.89|1.58|||Regression, Logistic|||||1.58|0.89|0.243
71799018|NCT03670810|143097784|SUPERIORITY|||||||0.142|||||||ANCOVA|||||||0.142
71799019|NCT03670810|143097785|SUPERIORITY||Odds Ratio (OR)|3.01||||0.004|TWO_SIDED|95.0|1.42|6.4|||Regression, Logistic|||||6.40|1.42|0.004
71799020|NCT03670810|143097785|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.22|9.47|||Regression, Logistic|||||9.47|2.22|<0.001
71799021|NCT03670810|143097786|SUPERIORITY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.74|3.62|||Regression, Logistic|||||3.62|1.74|<0.001
71799022|NCT03670810|143097786|SUPERIORITY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|2.5|5.2|||Regression, Logistic|||||5.20|2.50|<0.001
71799023|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|1.01||||0.953|TWO_SIDED|95.0|0.75|1.36|||Regression, Logistic|||Nausea||1.36|0.75|0.953
71799024|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|1.05||||0.768|TWO_SIDED|95.0|0.78|1.41|||Regression, Logistic|||Nausea||1.41|0.78|0.768
71799025|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.39|0.71|||Regression, Logistic|||Phonophobia||0.71|0.39|<0.001
71799026|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|0.46|||<|0.001|TWO_SIDED|95.0|0.34|0.62|||Regression, Linear|||Phonophobia||0.62|0.34|<0.001
71799027|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|0.48|||<|0.001|TWO_SIDED|95.0|0.36|0.63|||Regression, Logistic|||Photophobia||0.63|0.36|<0.001
71799028|NCT03670810|143097787|SUPERIORITY||Median Difference (Net)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71|||Regression, Logistic|||Photophobia||0.71|0.40|<0.001
71799029|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|0.46||||0.129|TWO_SIDED|95.0|0.17|1.25|||Regression, Logistic|||Vomiting||1.25|0.17|0.129
71799030|NCT03670810|143097787|SUPERIORITY||Odds Ratio (OR)|1.12||||0.769|TWO_SIDED|95.0|0.52|2.43|||Regression, Logistic|||Vomiting||2.43|0.52|0.769
71799031|NCT01420302|143097790|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71799032|NCT04875520|143097812|NON_INFERIORITY|Overall rate compared using GEE model includes any person affiliated with the school who tested positive at least once during the study period that the schools reported to us that were positive. This includes people in our testing program and not in our testing program.|Mean Difference (Final Values)|-0.01845||||0.25|TWO_SIDED|95.0|-0.04981|0.01292|||generalized estimating equations|||||0.01292|-0.04981|0.25
71799033|NCT05773287|143097828|SUPERIORITY|||||||0.509||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.509
71799034|NCT05773287|143097829|SUPERIORITY|||||||0.552||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||||||0.552
71799035|NCT03523117|143097846|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3108|TWO_SIDED||||||ANCOVA|||||||0.3108
71799036|NCT03523117|143097847|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
71799037|NCT03523117|143097848|SUPERIORITY||Mean Difference (Final Values)|15.64||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
71799038|NCT03523117|143097849|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
71799039|NCT02644967|143097854|OTHER|Estimation||||||0.0158||||||P-value of the overall response tested against the null rate of 11% based on 1-sided exact (Clopper-Pearson) test.|One-sided Clopper-Pearson test|||Testing the best overall confirmed response rate against the historical control rate of 0.11 (extracted from the literature review).||||0.0158
71799040|NCT02644967|143097855|OTHER|Estimation|Kaplan-Meier|5.06|||||TWO_SIDED|95.0|3.65|7.0|||||Kaplan-Meier estimate of median PFS in months.|||7.00|3.65|
71799041|NCT02644967|143097856|OTHER|Landmark analysis of overall survival at six (6) months.|Kaplan-Meier|87.5|||||TWO_SIDED|95.0|74.3|94.2|||||Kaplan-Meier estimate of percentage of participants surviving at six (6) months.|||94.2|74.3|
71799042|NCT02644967|143097857|OTHER|Landmark analysis of overall survival at twelve (12) months.|Kaplan-Meier|60.0|||||TWO_SIDED|95.0|44.7|72.4|||||Kaplan-Meier estimate of percentage of participants surviving at twelve (12) months.|||72.4|44.7|
71799043|NCT01502644|143097878|OTHER||Mean Difference (Net)|18.0||||0.01|TWO_SIDED|95.0|3.7|32.2|||Linear Mixed Modeling|Group, group×week, average baseline pain, and opioid use at baseline were entered as fixed effects using an autoregressive covariance structure.||||32.2|3.7|0.01
71799044|NCT02388997|143097881|SUPERIORITY|||||||0.59|||||||2-sample t-test with unequal variences|||||||0.59
71799045|NCT02388997|143097882|SUPERIORITY|||||||0.58|||||||2-sample t-test with unequal variances|||||||0.58
71799046|NCT02388997|143097883|SUPERIORITY|||||||0.87|||||||2-sample t-test with unequal variances|||||||0.87
71799047|NCT02388997|143097884|SUPERIORITY|||||||0.55|||||||2-sample t-test with unequal variances|||||||0.55
71799048|NCT02388997|143097885|SUPERIORITY|||||||0.6|||||||2-sample t-test with unequal variances|||||||0.6
71799049|NCT02388997|143097887|SUPERIORITY|||||||0.037||||||The p value is based on the fold change (ratio) of the geometric means of the time (days) to peak symptoms among asthmatics in the omalizumab/placebo treatment groups.|2-sample t-test on the log scale|||||||0.037
71799050|NCT01559311|143097900|SUPERIORITY_OR_OTHER|||||||0.1734|||||||Wilcoxon (Mann-Whitney)|||"* H01: μ LVEF, 1= μ LVEF, 2a vs H1a: μ LVEF, 1 \< μ LVEF, 2a~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2a is the mean of LVEF at month 12 in CRT-P ON Gp,"||||0.1734
71799051|NCT01559311|143097900|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||"* H03: μ LVEF, 1= μ LVEF, 2b vs H1a: μ LVEF, 1 \< μ LVEF, 2b~* Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~* μ LVEF, 2b is the mean of LVEF at month 12 in the CRT-P OFF Gp"||||0.1439
71896300|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|2.037||||0.081|TWO_SIDED|95.0|0.916|4.528||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.|||4.528|0.916|0.081
71799052|NCT01559311|143097901|SUPERIORITY_OR_OTHER|||||||0.6276|||||||Wilcoxon (Mann-Whitney)|||"* H02: μ LVESV, 1 = μ LVESV, 2a vs H1b: μ LVESV, 1 \> μ LVESV, 2a~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* μLVESV, 2a is the mean of LVESV at month 12 in the CRT-P ON group"||||0.6276
71799053|NCT01559311|143097901|SUPERIORITY_OR_OTHER|||||||0.5871|||||||Wilcoxon (Mann-Whitney)|||"* H04: μ LVESV, 1 = μ LVESV, 2b vs H1b: μ LVESV, 1 \> μ LVESV, 2b~* Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~* and μLVESV, 2b is the mean of LVESV at month 12 in CRT-P OFF group."||||0.5871
71799054|NCT02346240|143097902|SUPERIORITY||Estimated difference in responder rate|61.6|||||TWO_SIDED|95.0|52.1|71.2|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||71.2|52.1|
71799055|NCT02346240|143097902|SUPERIORITY||Estimated difference in responder rate|56.2|||||TWO_SIDED|95.0|46.4|66.0|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||66.0|46.4|
71799056|NCT02346240|143097902|SUPERIORITY||Odds Ratio (OR)|37.988|||<|0.0001|TWO_SIDED|95.0|11.312|127.576||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||127.576|11.312|<0.0001
71799057|NCT02346240|143097902|SUPERIORITY||Odds Ratio (OR)|30.023|||<|0.0001|TWO_SIDED|95.0|8.971|100.481||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||100.481|8.971|<0.0001
71799058|NCT02346240|143097902|SUPERIORITY||Estimated difference in responder rate|13.4|||||TWO_SIDED|95.0|2.7|24.1|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||24.1|2.7|
71799059|NCT02346240|143097902|SUPERIORITY||Estimated difference in responder rate|8.0|||||TWO_SIDED|95.0|-2.9|18.9|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||18.9|-2.9|
71799060|NCT02346240|143097902|SUPERIORITY||Odds Ratio (OR)|1.756|||=|0.0152|TWO_SIDED|95.0|1.114|2.768||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.768|1.114|=0.0152
71799061|NCT02346240|143097902|SUPERIORITY||Odds Ratio (OR)|1.388|||=|0.1523|TWO_SIDED|95.0|0.886|2.175||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||2.175|0.886|=0.1523
71799062|NCT02346240|143097903|SUPERIORITY||Estimated difference in responder rate|48.5|||||TWO_SIDED|95.0|39.33|57.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||57.63|39.33|
71799063|NCT02346240|143097903|SUPERIORITY||Estimated difference in responder rate|37.9|||||TWO_SIDED|95.0|28.88|46.96|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.96|28.88|
71799064|NCT02346240|143097903|SUPERIORITY||Odds Ratio (OR)|56.129|||<|0.0001|TWO_SIDED|95.0|7.787|404.555||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||404.555|7.787|<0.0001
71799065|NCT02346240|143097903|SUPERIORITY||Odds Ratio (OR)|36.566|||=|0.0004|TWO_SIDED|95.0|5.061|264.196||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||264.196|5.061|=0.0004
71799066|NCT02346240|143097904|SUPERIORITY||Estimated difference in responder rate|33.8|||||TWO_SIDED|95.0|20.68|46.98|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||46.98|20.68|
71799067|NCT02346240|143097904|SUPERIORITY||Estimated difference in responder rate|31.0|||||TWO_SIDED|95.0|18.18|43.8|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||43.80|18.18|
71799068|NCT02346240|143097904|SUPERIORITY||Odds Ratio (OR)|39.949|||<|0.0001|TWO_SIDED|95.0|8.407|189.828||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||189.828|8.407|<0.0001
71799069|NCT02346240|143097904|SUPERIORITY||Odds Ratio (OR)|35.084|||<|0.0001|TWO_SIDED|95.0|7.363|167.179||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||167.179|7.363|<0.0001
71799070|NCT02346240|143097905|SUPERIORITY||Estimated difference in responder rate|70.9|||||TWO_SIDED|95.0|62.15|79.59|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||79.59|62.15|
71799071|NCT02346240|143097905|SUPERIORITY||Estimated difference in responder rate|64.4|||||TWO_SIDED|95.0|55.12|73.63|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||73.63|55.12|
71896301|NCT03114969|143314785|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.438|2.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||2.283|0.438|1.000
71896302|NCT03114969|143314786|SUPERIORITY||Odds Ratio (OR)|1.935||||0.067|TWO_SIDED|95.0|0.955|3.921||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.921|0.955|0.067
71840872|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.403|||<|0.0001|TWO_SIDED|95.0|-4.005|-2.801|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.801|-4.005|<.0001
71840873|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.747|||<|0.0001|TWO_SIDED|95.0|-4.473|-3.02|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.020|-4.473|<.0001
71840874|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-4.461|-3.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-3.018|-4.461|<.0001
71840875|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.197|||<|0.0001|TWO_SIDED|95.0|-3.784|-2.61|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.610|-3.784|<.0001
71840876|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.678|-2.921|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||-2.921|-3.678|<.0001
71896303|NCT03114969|143314786|SUPERIORITY||Odds Ratio (OR)|2.523||||0.007|TWO_SIDED|95.0|1.283|4.961||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.961|1.283|0.007
71799072|NCT02346240|143097905|SUPERIORITY||Odds Ratio (OR)|76.277|||<|0.0001|TWO_SIDED|95.0|17.952|324.094||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.094|17.952|<0.0001
71799073|NCT02346240|143097905|SUPERIORITY||Odds Ratio (OR)|55.413|||<|0.0001|TWO_SIDED|95.0|13.135|233.782||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||233.782|13.135|<0.0001
71799074|NCT02346240|143097906|SUPERIORITY||Estimated difference in responder rate|55.0|||||TWO_SIDED|95.0|45.59|64.35|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.35|45.59|
71799075|NCT02346240|143097906|SUPERIORITY||Estimated difference in responder rate|44.9|||||TWO_SIDED|95.0|35.39|54.49|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.49|35.39|
71799076|NCT02346240|143097906|SUPERIORITY||Odds Ratio (OR)|40.717|||<|0.0001|TWO_SIDED|95.0|9.741|170.198||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.198|9.741|<0.0001
71799077|NCT02346240|143097906|SUPERIORITY||Odds Ratio (OR)|27.165|||<|0.0001|TWO_SIDED|95.0|6.504|113.453||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||113.453|6.504|<0.0001
71799078|NCT02346240|143097907|SUPERIORITY||Estimated difference in responder rate|48.8|||||TWO_SIDED|95.0|34.22|63.41|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||63.41|34.22|
71799079|NCT02346240|143097907|SUPERIORITY||Estimated difference in responder rate|39.5|||||TWO_SIDED|95.0|25.58|53.38|||Regression, Logistic|Estimated responder rate, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||53.38|25.58|
71799080|NCT02346240|143097907|SUPERIORITY||Odds Ratio (OR)|72.278|||<|0.0001|TWO_SIDED|95.0|14.65|356.602||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||356.602|14.650|<0.0001
71799081|NCT02346240|143097907|SUPERIORITY||Odds Ratio (OR)|49.527|||<|0.0001|TWO_SIDED|95.0|10.002|245.256||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||245.256|10.002|<0.0001
71799082|NCT03385239|143097946|SUPERIORITY||Mean Difference in % CFB|-27.0||||0.0042|TWO_SIDED|95.0|-41.0|-10.0|||ANCOVA||Mean difference in percent (%) change from baseline (CFB) based on difference in least square mean (LSM) of log (Primary Analysis Time Point/Baseline) was estimated.|||-10|-41|0.0042
71799083|NCT03385239|143097946|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-48.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-48|-66|<0.0001
71799084|NCT03385239|143097946|SUPERIORITY||Mean Difference in % CFB|-63.0|||<|0.0001|TWO_SIDED|95.0|-70.0|-54.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-54|-70|<0.0001
71896304|NCT03114969|143314787|SUPERIORITY||Odds Ratio (OR)|2.399||||0.008|TWO_SIDED|95.0|1.252|4.596||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.596|1.252|0.008
71896305|NCT03114969|143314787|SUPERIORITY||Odds Ratio (OR)|1.812||||0.082|TWO_SIDED|95.0|0.926|3.544||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||3.544|0.926|0.082
71896306|NCT03114969|143314787|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.135|6.905||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||6.905|2.135|<0.001
71799085|NCT03385239|143097946|SUPERIORITY||Mean Difference in % CFB|-62.0|||<|0.0001|TWO_SIDED|95.0|-69.0|-53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|||-53|-69|<0.0001
71799086|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-30.0||||0.0123|TWO_SIDED|95.0|-47.0|-8.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoC III||-8|-47|0.0123
71799087|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-68.0|||<|0.0001|TWO_SIDED|95.0|-76.0|-58.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-58|-76|<0.0001
71799088|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-65.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-65|-80|<0.0001
71799089|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-74.0|||<|0.0001|TWO_SIDED|95.0|-80.0|-66.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Apo-C III||-66|-80|<0.0001
71799090|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.568|TWO_SIDED|95.0|-11.0|7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||7|-11|0.568
71799091|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-12.0||||0.008|TWO_SIDED|95.0|-19.0|-3.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||-3|-19|0.008
71799092|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-3.0||||0.4476|TWO_SIDED|95.0|-12.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||6|-12|0.4476
71799093|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-8.0||||0.0606|TWO_SIDED|95.0|-16.0|0.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|TC||0|-16|0.0606
71799094|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|7.0||||0.4509|TWO_SIDED|95.0|-10.0|26.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||26|-10|0.4509
71799095|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|4.0||||0.6746|TWO_SIDED|95.0|-12.0|23.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||23|-12|0.6746
71799096|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|29.0||||0.0032|TWO_SIDED|95.0|9.0|53.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||53|9|0.0032
71799097|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|12.0||||0.1996|TWO_SIDED|95.0|-6.0|32.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|LDL-C||32|-6|0.1996
71799098|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|12.0||||0.0373|TWO_SIDED|95.0|1.0|24.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||24|1|0.0373
71799099|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|34.0|||<|0.0001|TWO_SIDED|95.0|21.0|49.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||49|21|<0.0001
71799100|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|42.0|||<|0.0001|TWO_SIDED|95.0|28.0|57.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||57|28|<0.0001
71799101|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|30.0|||<|0.0001|TWO_SIDED|95.0|18.0|44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|HDL-C||44|18|<0.0001
71799102|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-7.0||||0.2826|TWO_SIDED|95.0|-18.0|6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||6|-18|0.2826
71799103|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-24.0|||<|0.0001|TWO_SIDED|95.0|-34.0|-14.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-14|-34|<0.0001
71799104|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-15.0||||0.0118|TWO_SIDED|95.0|-26.0|-4.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-4|-26|0.0118
71799105|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-20.0||||0.0009|TWO_SIDED|95.0|-29.0|-9.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|Non-HDL-C||-9|-29|0.0009
71799106|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-21.0||||0.0086|TWO_SIDED|95.0|-34.0|-6.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-6|-34|0.0086
71799107|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-53.0|||<|0.0001|TWO_SIDED|95.0|-60.0|-44.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-44|-60|<0.0001
71799108|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-58.0|||<|0.0001|TWO_SIDED|95.0|-64.0|-50.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-50|-64|<0.0001
71799109|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-60.0|||<|0.0001|TWO_SIDED|95.0|-66.0|-52.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|VLDL-C||-52|-66|<0.0001
71799110|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|2.0||||0.6801|TWO_SIDED|95.0|-7.0|13.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||13|-7|0.6801
71799111|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-16.0||||0.0007|TWO_SIDED|95.0|-24.0|-7.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-7|-24|0.0007
71799112|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-5.0||||0.3183|TWO_SIDED|95.0|-14.0|5.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||5|-14|0.3183
71799113|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|-10.0||||0.024|TWO_SIDED|95.0|-19.0|-1.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoB||-1|-19|0.024
71896307|NCT03114969|143314787|SUPERIORITY||Odds Ratio (OR)|3.231|||<|0.001|TWO_SIDED|95.0|1.81|5.766||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.766|1.810|<0.001
71674686|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.58||0.0098|TWO_SIDED|90.0|-2.32|-0.41|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.41|-2.32|0.0098
71799114|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|5.0||||0.0936|TWO_SIDED|95.0|-1.0|11.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||11|-1|0.0936
71799115|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|8.0|21.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||21|8|<0.0001
71799116|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|18.0|||<|0.0001|TWO_SIDED|95.0|11.0|25.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||25|11|<0.0001
71799117|NCT03385239|143097948|SUPERIORITY||Mean Difference in % CFB|14.0|||<|0.0001|TWO_SIDED|95.0|7.0|20.0|||ANCOVA||Mean difference in % CFB based on difference in LSM of log (Primary Analysis Time Point/Baseline) was estimated.|ApoA-I||20|7|<0.0001
71799118|NCT03385239|143097949|SUPERIORITY||Odds Ratio (OR)|3.34||||0.2591|TWO_SIDED|95.0|0.41|27.2|||Regression, Logistic|||||27.20|0.41|0.2591
71799119|NCT03385239|143097949|SUPERIORITY||Odds Ratio (OR)|84.02|||<|0.0001|TWO_SIDED|95.0|9.54|740.02|||Regression, Logistic|||||740.02|9.54|<0.0001
71799120|NCT03385239|143097949|SUPERIORITY||Odds Ratio (OR)|322.79|||<|0.0001|TWO_SIDED|95.0|20.31|5130.99|||Regression, Logistic|||||5130.99|20.31|<0.0001
71799121|NCT03385239|143097949|SUPERIORITY||Odds Ratio (OR)|342.13|||<|0.0001|TWO_SIDED|95.0|23.72|4933.89|||Regression, Logistic|||||4933.89|23.72|<0.0001
71799122|NCT03385239|143097950|SUPERIORITY||Odds Ratio (OR)|1.25||||0.9119|TWO_SIDED|95.0|0.02|69.88|||Regression, Logistic|||||69.88|0.02|0.9119
71799123|NCT03385239|143097950|SUPERIORITY||Odds Ratio (OR)|27.18||||0.0306|TWO_SIDED|95.0|1.36|542.48|||Regression, Logistic|||||542.48|1.36|0.0306
71799124|NCT03385239|143097950|SUPERIORITY||Odds Ratio (OR)|25.54||||0.0344|TWO_SIDED|95.0|1.27|514.2|||Regression, Logistic|||||514.20|1.27|0.0344
71799125|NCT03385239|143097950|SUPERIORITY||Odds Ratio (OR)|44.47||||0.0123|TWO_SIDED|95.0|2.28|866.49|||Regression, Logistic|||||866.49|2.28|0.0123
71799126|NCT01574703|143097954|SUPERIORITY_OR_OTHER|||||||0.37||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.37
71799127|NCT01574703|143097955|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.53
71896308|NCT03114969|143314788|SUPERIORITY||Odds Ratio (OR)|1.931||||0.12|TWO_SIDED|95.0|0.842|4.428||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||4.428|0.842|0.120
71799128|NCT01574703|143097956|SUPERIORITY_OR_OTHER|||||||0.34||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.||||0.34
71799129|NCT01574703|143097957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.49||||0.8375|TWO_SIDED|95.0|-5.22|4.23||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.23|-5.22|0.8375
71799130|NCT01574703|143097957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.978|TWO_SIDED|95.0|-5.2|5.05||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||5.05|-5.20|0.9780
71799131|NCT01574703|143097957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.13||||0.6142|TWO_SIDED|95.0|-5.54|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.27|-5.54|0.6142
71799132|NCT01574703|143097957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.42||||0.8602|TWO_SIDED|95.0|-4.28|5.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||5.13|-4.28|0.8602
71799133|NCT01574703|143097957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.64||||0.7217|TWO_SIDED|95.0|-4.15|2.88||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.88|-4.15|0.7217
71799134|NCT01574703|143097957|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.06||||0.6322|TWO_SIDED|95.0|-5.41|3.28||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.28|-5.41|0.6322
71799135|NCT01574703|143097958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.07||||0.9687|TWO_SIDED|95.0|-3.48|3.34||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||3.34|-3.48|0.9687
71799136|NCT01574703|143097958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.56||||0.7905|TWO_SIDED|95.0|-3.58|4.7||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||4.70|-3.58|0.7905
71840877|NCT04800211|143190998|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)|Mean Difference (Net)|-0.206||||0.348|TWO_SIDED|95.0|-0.638|0.226|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood COHb (% Saturation) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (MiTT Population)||0.226|-0.638|0.3480
71840878|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.716|||<|0.0001|TWO_SIDED|95.0|-0.951|-0.481|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5. (mITT Population)||-0.481|-0.951|<0.0001
71799137|NCT01574703|143097958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8962|TWO_SIDED|95.0|-3.36|2.94||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.94|-3.36|0.8962
71799138|NCT01574703|143097958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.63||||0.7767|TWO_SIDED|95.0|-3.72|4.98||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||4.98|-3.72|0.7767
71799139|NCT01574703|143097958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.926|TWO_SIDED|95.0|-3.13|2.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.85|-3.13|0.9260
71799140|NCT01574703|143097958|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77||||0.7113|TWO_SIDED|95.0|-4.85|3.31||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.31|-4.85|0.7113
71799141|NCT01574703|143097959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.8117|TWO_SIDED|95.0|-5.27|4.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||4.13|-5.27|0.8117
71799142|NCT01574703|143097959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.78||||0.7303|TWO_SIDED|95.0|-5.21|3.65||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.65|-5.21|0.7303
71799143|NCT01574703|143097959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.5946|TWO_SIDED|95.0|-5.6|3.21||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||3.21|-5.60|0.5946
71799144|NCT01574703|143097959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.92|TWO_SIDED|95.0|-4.27|3.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.85|-4.27|0.9200
71896309|NCT03114969|143314788|SUPERIORITY||Odds Ratio (OR)|1.636||||0.232|TWO_SIDED|95.0|0.73|3.664||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||3.664|0.730|0.232
71799145|NCT01574703|143097959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.62||||0.7236|TWO_SIDED|95.0|-4.09|2.84||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.84|-4.09|0.7236
71799146|NCT01574703|143097959|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.42||||0.8201|TWO_SIDED|95.0|-4.01|3.17||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||3.17|-4.01|0.8201
71799147|NCT01574703|143097960|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.21||||0.8932|TWO_SIDED|95.0|-3.22|2.81||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.81|-3.22|0.8932
71799148|NCT01574703|143097960|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.23||||0.8747|TWO_SIDED|95.0|-3.09|2.63||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.63|-3.09|0.8747
71799149|NCT01574703|143097960|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.6||||0.671|TWO_SIDED|95.0|-3.35|2.15||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.15|-3.35|0.6710
71799150|NCT01574703|143097960|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.9886|TWO_SIDED|95.0|-3.32|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||3.27|-3.32|0.9886
71799151|NCT01574703|143097960|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.39||||0.7631|TWO_SIDED|95.0|-2.92|2.14||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.14|-2.92|0.7631
71799152|NCT01574703|143097960|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.8022|TWO_SIDED|95.0|-3.23|2.5||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.50|-3.23|0.8022
71799153|NCT01574703|143097961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.91||||0.6441|TWO_SIDED|95.0|-4.78|2.96||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||2.96|-4.78|0.6441
71799154|NCT01574703|143097961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.69||||0.7327|TWO_SIDED|95.0|-4.63|3.26||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||3.26|-4.63|0.7327
71799155|NCT01574703|143097961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.99||||0.6109|TWO_SIDED|95.0|-4.8|2.82||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||2.82|-4.80|0.6109
71799156|NCT01574703|143097961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.8707|TWO_SIDED|95.0|-2.48|2.93||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.93|-2.48|0.8707
71799157|NCT01574703|143097961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.08||||0.9531|TWO_SIDED|95.0|-2.63|2.48||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.48|-2.63|0.9531
71799158|NCT01574703|143097961|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||0.8262|TWO_SIDED|95.0|-2.99|2.39||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.39|-2.99|0.8262
71799159|NCT01574703|143097962|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.59||||0.6105|TWO_SIDED|95.0|-2.84|1.67||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.||1.67|-2.84|0.6105
71799160|NCT01574703|143097962|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.32||||0.7895|TWO_SIDED|95.0|-2.65|2.01||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.||2.01|-2.65|0.7895
71799161|NCT01574703|143097962|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.48||||0.6804|TWO_SIDED|95.0|-2.75|1.8||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.||1.80|-2.75|0.6804
71840879|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.686|||<|0.0001|TWO_SIDED|95.0|-0.966|-0.406|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 7. (mITT Population)||-0.406|-0.966|<0.0001
71840880|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.521|||<|0.0001|TWO_SIDED|95.0|-0.755|-0.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 5. (mITT Population)||-0.288|-0.755|<.0001
71799162|NCT01574703|143097962|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.27||||0.8127|TWO_SIDED|95.0|-1.95|2.49||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.||2.49|-1.95|0.8127
71799163|NCT01574703|143097962|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||0.9218|TWO_SIDED|95.0|-2.04|2.25||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.||2.25|-2.04|0.9218
71799164|NCT01574703|143097962|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16||||0.8841|TWO_SIDED|95.0|-2.32|2.0||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.||2.00|-2.32|0.8841
71799165|NCT01387607|143097969|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1906||0.0001|TWO_SIDED|95.0|-1.1|-0.36||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.36|-1.10|0.0001
71799166|NCT01387607|143097970|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4376||||0.1397|TWO_SIDED|95.0|0.8732|2.3667||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.||2.3667|0.8732|0.1397
71799167|NCT01387607|143097970|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4626||||0.151|TWO_SIDED|95.0|0.8596|2.4886||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.||2.4886|0.8596|0.1510
71799168|NCT01387607|143097971|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|1.6804||0.0762|TWO_SIDED|95.0|-6.3|0.32||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.32|-6.30|0.0762
71799169|NCT01387607|143097972|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8924||||0.0044|TWO_SIDED|95.0|1.2007|2.9827||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||2.9827|1.2007|0.0044
71799170|NCT01387607|143097973|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9683||||0.0189|TWO_SIDED|95.0|1.1151|3.4742||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.|||3.4742|1.1151|0.0189
71799171|NCT01387607|143097974|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.427|STANDARD_ERROR_OF_MEAN|2.0152||0.09|TWO_SIDED|95.0|-7.39|0.54||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.54|-7.39|0.0900
71840881|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.342||||0.0131|TWO_SIDED|95.0|-0.612|-0.072|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.072|-0.612|0.0131
71799172|NCT01387607|143097975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.527|STANDARD_ERROR_OF_MEAN|2.1858||0.2485|TWO_SIDED|95.0|-1.77|6.83||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for snoring.||6.83|-1.77|0.2485
71840882|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|-0.514|||<|0.0001|TWO_SIDED|95.0|-0.712|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 7. (mITT Population)||-0.316|-0.712|<.0001
71799173|NCT01387607|143097975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.355|STANDARD_ERROR_OF_MEAN|2.265||0.2993|TWO_SIDED|95.0|-6.81|2.1||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for awaken short of breath.||2.10|-6.81|0.2993
71799174|NCT01387607|143097975|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.03|STANDARD_ERROR_OF_MEAN|2.4485||0.0003|TWO_SIDED|95.0|4.21|13.85||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for sleep adequacy.||13.85|4.21|0.0003
71799175|NCT01387607|143097976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.1114||0.0106|TWO_SIDED|95.0|0.07|0.51||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for quantity of sleep.||0.51|0.07|0.0106
71799176|NCT01387607|143097976|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.194|STANDARD_ERROR_OF_MEAN|1.6428||0.0112|TWO_SIDED|95.0|0.96|7.43||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for somnolence||7.43|0.96|0.0112
71674687|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61||0.1285|TWO_SIDED|90.0|-1.71|0.32|||MMRM|||Week 10: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.32|-1.71|0.1285
71674688|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.6||0.3243|TWO_SIDED|90.0|-1.27|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.27|0.3243
71799177|NCT01387607|143097977|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.059|STANDARD_ERROR_OF_MEAN|1.6438||0.0637|TWO_SIDED|95.0|-6.29|0.18||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||||0.18|-6.29|0.0637
71799178|NCT01387607|143097978|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6767|TWO_SIDED|95.0|0.67|1.87||Logistic regression model includes treatment and pooled center as factors and baseline value as covariate.|Regression, Logistic|||||1.87|0.67|0.6767
71799179|NCT01387607|143097979|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.882|STANDARD_ERROR_OF_MEAN|0.1932|<|0.0001|TWO_SIDED|95.0|-1.26|-0.5||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.50|-1.26|<0.0001
71799180|NCT01387607|143097980|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.172|STANDARD_ERROR_OF_MEAN|7.7785||0.0273|TWO_SIDED|95.0|-32.42|-1.92||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-1.92|-32.42|0.0273
71799181|NCT01387607|143097981|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0677||0.8082|TWO_SIDED|95.0|-0.12|0.15||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||0.15|-0.12|0.8082
71799182|NCT01387607|143097982|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.655|STANDARD_ERROR_OF_MEAN|0.1223|<|0.0001|TWO_SIDED|95.0|-0.89|-0.41||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||-0.41|-0.89|<0.0001
71799183|NCT01387607|143097983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.396|STANDARD_ERROR_OF_MEAN|7.7309||0.3388|TWO_SIDED|95.0|-7.76|22.55||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||22.55|-7.76|0.3388
71799184|NCT01387607|143097984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.765|STANDARD_ERROR_OF_MEAN|0.2115||0.0003|TWO_SIDED|95.0|0.35|1.18||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures|||||1.18|0.35|0.0003
71840883|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)|Mean Difference (Net)|-0.231||||0.0435|TWO_SIDED|95.0|-0.455|-0.007|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5. (mITT Population)||-0.007|-0.455|0.0435
71840884|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)|Mean Difference (Net)|0.111||||0.4012|TWO_SIDED|95.0|-0.149|0.371|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 7. (mITT Population)||0.371|-0.149|0.4012
71674689|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.61||0.3795|TWO_SIDED|90.0|-1.2|0.82|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.82|-1.20|0.3795
71799185|NCT01387607|143097985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.8414||0.3186|TWO_SIDED|95.0|-2.5|0.82||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.82|-2.50|0.3186
71799186|NCT01387607|143097986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|1.0404||0.7149|TWO_SIDED|95.0|-1.67|2.43||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.43|-1.67|0.7149
71799187|NCT01387607|143097987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|0.673||0.2442|TWO_SIDED|95.0|-0.54|2.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||2.11|-0.54|0.2442
71799188|NCT01387607|143097988|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.616|STANDARD_ERROR_OF_MEAN|2.4019||0.1332|TWO_SIDED|95.0|-8.34|1.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||1.11|-8.34|0.1332
71799189|NCT01387607|143097989|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.3595||0.2934||95.0|-1.09|0.33||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||0.33|-1.09|0.2934
71799190|NCT01387607|143097990|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.3621||0.0226|TWO_SIDED|95.0|-1.54|-0.12||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA|||||-0.12|-1.54|0.0226
71799191|NCT02908529|143097993|SUPERIORITY||Median Difference (Final Values)|-15.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71799192|NCT05569954|143097995|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-1.6|||||TWO_SIDED|95.0|-4.0|0.7|||||V116 minus PPSV23|Injection site erythema: estimated difference in percent||0.7|-4.0|
71799193|NCT05569954|143097995|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|3.7|||||TWO_SIDED|95.0|-1.2|8.7|||||V116 minus PPSV23|Injection site pain: estimated difference in percent||8.7|-1.2|
71799194|NCT05569954|143097995|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.6|||||TWO_SIDED|95.0|-1.6|2.7|||||V116 minus PPSV23|Injection site swelling: estimated difference in percent||2.7|-1.6|
71799195|NCT05569954|143097996|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.9|||||TWO_SIDED|95.0|-2.9|4.6|||||V116 minus PPSV23|Fatigue: estimated difference in percent||4.6|-2.9|
71799196|NCT05569954|143097996|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|1.7||||||95.0|-1.8|5.1|||||V116 minus PPSV23|Headache: estimated difference in percent||5.1|-1.8|
71799197|NCT05569954|143097996|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.7||||||95.0|-3.1|1.7|||||V116 minus PPSV23|Myalgia: estimated difference in percent||1.7|-3.1|
71799198|NCT05569954|143097996|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|-0.3||||||95.0|-1.5|0.9|||||V116 minus PPSV23|Pyrexia: estimated difference in percent||0.9|-1.5|
71799199|NCT05569954|143097997|OTHER|Estimated difference in percent and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Difference in Percent|0.0||||||95.0|-0.5|0.5|||||V116 minus PPSV23|Vaccine-Related Serious Adverse Events||0.5|-0.5|
71799200|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.23||1-sided|cLDA model||V116/PPSV23|Serotype 3: V116/PPSV23 GMT Ratio||1.23|0.96|<0.001
71799201|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.47|||<|0.001|TWO_SIDED|95.0|1.29|1.68||1-sided|cLDA model||V116/PPSV23|Serotype 7F: V116/PPSV23 GMT Ratio||1.68|1.29|<0.001
71799202|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.17|||<|0.001|TWO_SIDED|95.0|1.04|1.32||1-sided|cLDA model||V116/PPSV23|Serotype 8: V116/PPSV23 GMT Ratio||1.32|1.04|<0.001
71799203|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.12|||<|0.001||95.0|1.0|1.26||1-sided|cLDA model||V116/PPSV23|Serotype 9N: V116/PPSV23 GMT Ratio||1.26|1.00|<0.001
71799204|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.55|||<|0.001|TWO_SIDED|95.0|1.37|1.77|||cLDA model||V116/PPSV23|Serotype 10A: V116/PPSV23 GMT Ratio||1.77|1.37|<0.001
71799205|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.05|||<|0.001||95.0|1.82|2.31|||cLDA model||V116/PPSV23|Serotype 11A: V116/PPSV23 GMT Ratio||2.31|1.82|<0.001
71799206|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.63|||<|0.001|TWO_SIDED|95.0|1.4|1.9|||cLDA model||V116/PPSV23|Serotype 12F: V116/PPSV23 GMT Ratio||1.90|1.40|<0.001
71799207|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.77|2.31|||cLDA model||V116/PPSV23|Serotype 17F: V116/PPSV23GMT Ratio||2.31|1.77|<0.001
71799208|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.42|||<|0.001|TWO_SIDED|95.0|1.26|1.6|||cLDA model||V116/PPSV23|Serotype 19A: V116/PPSV23 GMT Ratio||1.60|1.26|<0.001
71799209|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.46|1.88|||cLDA model||V116/PPSV23|Serotype 20A: V116/PPSV23 GMT Ratio||1.88|1.46|<0.001
71799210|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|1.53|||<|0.001|TWO_SIDED|95.0|1.34|1.75|||cLDA model||V116/PPSV23|Serotype 22F: V116/PPSV23 GMT Ratio||1.75|1.34|<0.001
71799211|NCT05569954|143097998|NON_INFERIORITY|A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>0.5 (one-sided p-value \<0.025).|GMT Ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.76|1.04|||cLDA model||V116/PPSV23|Serotype 33F: V116/PPSV23 GMT Ratio||1.04|0.76|<0.001
71799212|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.31|||<|0.001|TWO_SIDED|95.0|2.84|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 6A: V116/PPSV23 GMT Ratio||3.87|2.84|<0.001
71799213|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.61|||<|0.001|TWO_SIDED|95.0|3.99|5.33||1-sided|cLDA model||V116/PPSV23|Serotype 15A: V116/PPSV23 GMT Ratio||5.33|3.99|<0.001
71799214|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|2.92|||<|0.001||95.0|2.5|3.42||1-sided|cLDA model||V116/PPSV23|Serotype 15C: V116/PPSV23 GMT Ratio||3.42|2.50|<0.001
71674690|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.62||0.307|TWO_SIDED|90.0|-1.35|0.72|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.72|-1.35|0.3070
71674691|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59||0.1014|TWO_SIDED|90.0|-1.74|0.22|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.22|-1.74|0.1014
71674692|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.62||0.0033|TWO_SIDED|90.0|-2.75|-0.69|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.69|-2.75|0.0033
71674693|NCT03850483|142867384|SUPERIORITY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.028|TWO_SIDED|90.0|-2.18|-0.17|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||-0.17|-2.18|0.0280
71674694|NCT03850483|142867384|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.64||0.0781|TWO_SIDED|90.0|-1.98|0.15|||MMRM|||Week 12: MMRM analysis contained treatment, visit, and treatment by visit interaction as fixed factors, and baseline value as a covariate. Unstructured covariance matrix was used for model errors.||0.15|-1.98|0.0781
71674695|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
71674696|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 1||9.1|-9.4|0.4216
71674697|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7362|TWO_SIDED|90.0|-12.5|5.0|||Chan and Zhang method|||Week 1||5.0|-12.5|0.7362
71799215|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|4.5|||<|0.001|TWO_SIDED|95.0|3.99|5.09||1-sided|cLDA model||V116/PPSV23|Serotype 16F: V116/PPSV23 GMT Ratio||5.09|3.99|<0.001
71799216|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|5.74|||<|0.001|TWO_SIDED|95.0|4.81|6.85||1-sided|cLDA model||V116/PPSV23|Serotype 23A: V116/PPSV23 GMT Ratio||6.85|4.81|<0.001
71799217|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|16.42|||<|0.001|TWO_SIDED|95.0|13.46|20.03||1-sided|cLDA model||V116/PPSV23|Serotype 23B: V116/PPSV23 GMT Ratio||20.03|13.46|<0.001
71674698|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 1||4.7|-12.5|0.7417
71674699|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-5.9|8.0|||Chan and Zhang method|||Week 1||8.0|-5.9|0.5000
71799218|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|3.39|||<|0.001||95.0|2.97|3.87||1-sided|cLDA model||V116/PPSV23|Serotype 24F: V116/PPSV23 GMT Ratio||3.87|2.97|<0.001
71674700|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.7||||0.0714|TWO_SIDED|90.0|-0.8|16.9|||Chan and Zhang method|||Week 1||16.9|-0.8|0.0714
71674701|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.3||||0.0813|TWO_SIDED|90.0|-1.1|15.7|||Chan and Zhang method|||Week 1||15.7|-1.1|0.0813
71674702|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
71674703|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.8||||0.7417|TWO_SIDED|90.0|-12.5|4.7|||Chan and Zhang method|||Week 2||4.7|-12.5|0.7417
71674704|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-9.6|9.6|||Chan and Zhang method|||Week 2||9.6|-9.6|0.5000
71674705|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.1||||0.4216|TWO_SIDED|90.0|-9.4|9.1|||Chan and Zhang method|||Week 2||9.1|-9.4|0.4216
71674706|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.0||||0.6894|TWO_SIDED|90.0|-9.4|5.9|||Chan and Zhang method|||Week 2||5.9|-9.4|0.6894
71674707|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|3.7||||0.2518|TWO_SIDED|90.0|-4.2|14.3|||Chan and Zhang method|||Week 2||14.3|-4.2|0.2518
71674708|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|8.5||||0.0565|TWO_SIDED|90.0|-0.3|20.3|||Chan and Zhang method|||Week 2||20.3|-0.3|0.0565
71674709|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
71674710|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-5.6||||0.9001|TWO_SIDED|90.0|-16.5|1.9|||Chan and Zhang method|||Week 4||1.9|-16.5|0.9001
71674711|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.5000
71674712|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4446|TWO_SIDED|90.0|-11.0|11.0|||Chan and Zhang method|||Week 4||11.0|-11.0|0.4446
71799219|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|11.89|||<|0.001|TWO_SIDED|95.0|10.16|13.91||1-sided|cLDA model||V116/PPSV23|Serotype 31: V116/PPSV23 GMT Ratio||13.91|10.16|<0.001
71674713|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 4||12.5|-10.5|0.5054
71799220|NCT05569954|143097998|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PPSV23) being \>2.0 (one-sided p-value \<0.025).|GMT Ratio|6.17|||<|0.001|TWO_SIDED|95.0|5.54|6.87||1-sided|cLDA model||V116/PPSV23|Serotype 35B: V116/PPSV23 GMT Ratio||6.87|5.54|<0.001
71896310|NCT03114969|143314789|SUPERIORITY||Odds Ratio (OR)|4.217|||<|0.001|TWO_SIDED|95.0|2.019|8.807||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||8.807|2.019|<0.001
71799221|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|26.0|||<|0.001|TWO_SIDED|95.0|20.9|31.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 6A: V116-PPSV23 Percentage Difference||31.0|20.9|<0.001
71799222|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|39.4|||<|0.001|TWO_SIDED|95.0|33.6|44.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15A: V116-PPSV23 Percentage Difference||44.8|33.6|<0.001
71799223|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|11.7||||0.214|TWO_SIDED|95.0|7.5|15.9||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 15C: V116-PPSV23 Percentage Difference||15.9|7.5|0.214
71799224|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.9|||<|0.001|TWO_SIDED|95.0|37.8|47.8||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 16F: V116-PPSV23 Percentage Difference||47.8|37.8|<0.001
71799225|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|29.6|41.8||1-sided|Stratified Miettinen & Nurminen method||V16 minus PPSV23|Serotype 23A: V116-PPSV23 Percentage Difference||41.8|29.6|<0.001
71799226|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|42.4|||<|0.001|TWO_SIDED|95.0|37.6|47.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 23B: V116-PPSV23 Percentage Difference||47.0|37.6|<0.001
71799227|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|35.9|||<|0.001||95.0|30.6|41.0||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 24F: V116-PPSV23 Percentage Difference||41.0|30.6|<0.001
71799228|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|56.2|||<|0.001|TWO_SIDED|95.0|51.5|60.5||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 31: V116-PPSV23 Percentage Difference||60.5|51.5|<0.001
71799229|NCT05569954|143097999|SUPERIORITY|A conclusion of superiority is based on the lower bound of the 95% CI for the difference \[V116 - PPSV23\] between the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being \>10 percentage points (1-sided p-value \<0.025).|Percent Difference|58.7|||<|0.001||95.0|54.6|62.7||1-sided|Stratified Miettinen & Nurminen method||V116 minus PPSV23|Serotype 35B: V116-PPSV23 Percentage Difference||62.7|54.6|<0.001
71799230|NCT05569954|143098000|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."||||||0.093||||||1-sided|Clopper-Pearson method|||Serotype 6C||||0.093
71799231|NCT05569954|143098000|OTHER|"A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a~≥4 fold rise from baseline to 30 days postvaccination being \>50 percentage points (1-sided p-value \<0.025)."|||||<|0.001||||||1-sided|Clopper-Pearson method|||Serotype 15B||||<0.001
71799232|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.14|||||TWO_SIDED|95.0|1.04|1.25|||||V116/PPSV23|Serotype 3: V116/PPSV23 GMC Ratio||1.25|1.04|
71674714|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|3.3||||0.3401|TWO_SIDED|90.0|-8.2|16.9|||Chan and Zhang method|||Week 4||16.9|-8.2|0.3401
71674715|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|12.9||||0.0489|TWO_SIDED|90.0|0.1|27.5|||Chan and Zhang method|||Week 4||27.5|0.1|0.0489
71674716|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 6||8.4|-14.8|0.6349
71799233|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 7F: V116/PPSV23 GMC Ratio||2.10|1.65|
71799234|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.17|||||TWO_SIDED|95.0|1.04|1.31|||||V116/PPSV23|Serotype 8: V116/PPSV23 GMC Ratio||1.31|1.04|
71674717|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-5.6||||0.8253|TWO_SIDED|90.0|-17.2|4.4|||Chan and Zhang method|||Week 6||4.4|-17.2|0.8253
71674718|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 6||12.5|-12.5|0.5000
71799235|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.76|||||V116/PPSV23|Serotype 9N: V116/PPSV23 GMC Ratio||1.76|1.37|
71799236|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.03|||||TWO_SIDED|95.0|1.79|2.31|||||V116/PPSV23|Serotype 10A: V116/PPSV23 GMC Ratio||2.31|1.79|
71799237|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.2|||||TWO_SIDED|95.0|1.97|2.46|||||V116/PPSV23|Serotype 11A: V116/PPSV23 GMC Ratio||2.46|1.97|
71799238|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.72|2.3|||||V116/PPSV23|Serotype 12F: V116/PPSV23 GMC Ratio||2.30|1.72|
71799239|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|2.39|||||TWO_SIDED|95.0|2.12|2.7|||||V116/PPSV23|Serotype 17F: V116/PPSV23 GMC Ratio||2.70|2.12|
71840885|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.485||||0.0133|TWO_SIDED|95.0|-0.895|-0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5. (mITT Population)||-0.074|-0.895|0.0133
71840886|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.797||||0.0002|TWO_SIDED|95.0|-1.277|-0.317|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7. (mITT Population)||-0.317|-1.277|0.0002
71840887|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)|Mean Difference (Net)|-0.29||||0.2641|TWO_SIDED|95.0|-0.699|0.119|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5. (mITT Population)||0.119|-0.699|0.2641
71840888|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.453||||0.0639|TWO_SIDED|95.0|-0.924|0.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7. (mITT Population)||0.018|-0.924|0.0639
71840889|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)|Mean Difference (Net)|-0.625||||0.0001|TWO_SIDED|95.0|-0.945|-0.305|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 7. (mITT Population)||-0.305|-0.945|0.0001
71674719|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.2||||0.2709|TWO_SIDED|90.0|-8.3|19.1|||Chan and Zhang method|||Week 6||19.1|-8.3|0.2709
71674720|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.2||||0.5054|TWO_SIDED|90.0|-10.5|12.5|||Chan and Zhang method|||Week 6||12.5|-10.5|0.5054
71674721|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.4||||0.6319|TWO_SIDED|90.0|-12.9|9.3|||Chan and Zhang method|||Week 6||9.3|-12.9|0.6319
71799240|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.49|||||TWO_SIDED|95.0|1.32|1.67||||||Serotype 19A: V116/PPSV23 GMC Ratio|V116/PPSV23|1.67|1.32|
71799241|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.86|||||TWO_SIDED|95.0|1.65|2.1|||||V116/PPSV23|Serotype 20A: V116/PPSV23 GMC Ratio||2.10|1.65|
71799242|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.77|||||TWO_SIDED|95.0|1.55|2.02|||||V116/PPSV23|Serotype 22F: V116/PPSV23 GMC Ratio||2.02|1.55|
71799243|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.08|1.37|||||V116/PPSV23|Serotype 33F: V116/PPSV23 GMC Ratio||1.37|1.08|
71799244|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.78|||||TWO_SIDED|95.0|3.29|4.35|||||V116/PPSV23|Serotype 6A: V116/PPSV23 GMC Ratio||4.35|3.29|
71799245|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.92|||||TWO_SIDED|95.0|7.89|10.09|||||V116/PPSV23|Serotype 15A: V116/PPSV23 GMC Ratio||10.09|7.89|
71674722|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.0||||0.3199|TWO_SIDED|90.0|-6.4|18.1|||Chan and Zhang method|||Week 6||18.1|-6.4|0.3199
71799246|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|3.43|||||TWO_SIDED|95.0|3.01|3.92|||||V116/PPSV23|Serotype 15C: V116/PPSV23 GMC Ratio||3.92|3.01|
71799247|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|9.84|||||TWO_SIDED|95.0|8.83|10.97|||||V116/PPSV23|Serotype 16F: V116/PPSV23 GMC Ratio||10.97|8.83|
71799248|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|7.59|||||TWO_SIDED|95.0|6.68|8.61|||||V116/PPSV23|Serotype 23A: V116/PPSV23 GMC Ratio||8.61|6.68|
71799249|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|4.79|||||TWO_SIDED|95.0|4.26|5.38|||||V116/PPSV23|Serotype 23B: V116/PPSV23 GMC Ratio||5.38|4.26|
71799250|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|21.19||||||95.0|18.98|23.65|||||V116/PPSV23|Serotype 24F: V116/PPSV23 GMC Ratio||23.65|18.98|
71799251|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|8.69|||||TWO_SIDED|95.0|7.82|9.65|||||V116/PPSV23|Serotype 31: V116/PPSV23 GMC Ratio||9.65|7.82|
71799252|NCT05569954|143098002|OTHER|GMCs, GMC ratio, and 95% CI are estimated from a cLDA model.|GMC Ratio|15.53|||||TWO_SIDED|95.0|14.13|17.07|||||V116/PPSV23|Serotype 35B: V116/PPSV23 GMC Ratio||17.07|14.13|
71799253|NCT02239536|143098006|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71799254|NCT02239536|143098007|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71799255|NCT02239536|143098007|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71799256|NCT04524403|143098062|SUPERIORITY||Least Squares Mean Difference|0.24||||0.787|TWO_SIDED|95.0|-1.52|2.01|||Mixed Models Analysis|||||2.01|-1.52|0.7870
71799257|NCT04524403|143098062|SUPERIORITY||Least Squares Mean Difference|0.75||||0.4018|TWO_SIDED|95.0|-1.01|2.51|||Mixed Models Analysis|||||2.51|-1.01|0.4018
71799258|NCT04524403|143098063|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5228|TWO_SIDED|95.0|-1.03|2.02|||Mixed Models Analysis|||||2.02|-1.03|0.5228
71799259|NCT04524403|143098064|SUPERIORITY||Odds Ratio (OR)|1.781||||0.2537|TWO_SIDED|95.0|0.661|4.802|||Regression, Logistic|||||4.802|0.661|0.2537
71896311|NCT03114969|143314789|SUPERIORITY||Odds Ratio (OR)|5.41|||<|0.001|TWO_SIDED|95.0|2.66|11.005||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.|||11.005|2.660|<0.001
71674723|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
71799260|NCT04524403|143098064|SUPERIORITY||Odds Ratio (OR)|0.916||||0.874|TWO_SIDED|95.0|0.308|2.722|||Regression, Logistic|||||2.722|0.308|0.8740
71799261|NCT04524403|143098065|SUPERIORITY||Least Squares Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.021|0.021|||Mixed Models Analysis|||||0.021|-0.021|0.9870
71799262|NCT04524403|143098065|SUPERIORITY||Least Squares Mean Difference|0.008||||0.4624|TWO_SIDED|95.0|-0.013|0.029|||Mixed Models Analysis|||||0.029|-0.013|0.4624
71799263|NCT01513317|143098069|SUPERIORITY_OR_OTHER||Difference in proportions|0.082||||0.271|TWO_SIDED|95.0|-0.03|0.2|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS.|||0.20|-0.03|0.271
71799264|NCT01513317|143098070|SUPERIORITY_OR_OTHER||Difference in LS means|0.07||||0.872|TWO_SIDED|95.0|-0.79|0.93|||ANCOVA||The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13.|||0.93|-0.79|0.872
71799265|NCT01513317|143098071|SUPERIORITY_OR_OTHER||Difference in proportions|0.042||||0.494|TWO_SIDED|95.0|-0.06|0.15|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13.|||0.15|-0.06|0.494
71799266|NCT01513317|143098072|SUPERIORITY_OR_OTHER||Difference in proportions|0.002||||0.986|TWO_SIDED|95.0|-0.09|0.09|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13.|||0.09|-0.09|0.986
71799267|NCT01513317|143098073|SUPERIORITY_OR_OTHER||Difference in LS means|1.96||||0.363|TWO_SIDED|95.0|-2.35|6.27|||ANCOVA||The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13.|||6.27|-2.35|0.363
71799268|NCT01513317|143098074|SUPERIORITY_OR_OTHER||Difference in LS means|-1.69||||0.073|TWO_SIDED|95.0|-3.55|0.17|||ANCOVA||The estimated parameter is the difference in LS means of the number of RBC transfusions during the 8 weeks of treament before unblinding at Week 13.|||0.17|-3.55|0.073
71799269|NCT01221441|143098078|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
71799270|NCT01221441|143098079|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
71799271|NCT01221441|143098080|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated KOOS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for KOOS is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
71674724|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-5.7||||0.7306|TWO_SIDED|90.0|-19.1|6.1|||Chan and Zhang method|||Week 8||6.1|-19.1|0.7306
71674725|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-8.3||||0.8808|TWO_SIDED|90.0|-20.6|2.7|||Chan and Zhang method|||Week 8||2.7|-20.6|0.8808
71799272|NCT01221441|143098081|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger's method.||"The efficacy evaluation at week 104 evaluated Lysholm score with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for Lysholm score is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."||||<0.01
71799273|NCT02665481|143098096|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.07|-0.15|0.50
71799274|NCT02665481|143098096|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.18|TWO_SIDED|95.0|-0.04|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.19|-0.04|0.18
71799275|NCT02665481|143098096|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.23|TWO_SIDED|95.0|-0.04|0.17|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.17|-0.04|0.23
71799276|NCT02665481|143098096|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.47|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x Exercise (Month 0 and Month 18)||0.07|-0.15|0.47
71799277|NCT02665481|143098097|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.12|TWO_SIDED|95.0|-0.02|0.19|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.19|-0.02|0.12
71799278|NCT02665481|143098097|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.44|TWO_SIDED|95.0|-0.15|0.07|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||0.07|-0.15|0.44
71799279|NCT02665481|143098097|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.17|TWO_SIDED|95.0|-0.03|0.18|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||0.18|-0.03|0.17
71799280|NCT02665481|143098097|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.93|TWO_SIDED|95.0|-0.12|0.11|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.11|-0.12|0.93
71799281|NCT02665481|143098098|SUPERIORITY||Mean Difference (Final Values)|-3.46||||0.53|TWO_SIDED|95.0|-14.27|7.34|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||7.34|-14.27|0.53
71674726|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.3||||0.4644|TWO_SIDED|90.0|-13.7|13.7|||Chan and Zhang method|||Week 8||13.7|-13.7|0.4644
71799282|NCT02665481|143098098|SUPERIORITY||Mean Difference (Final Values)|-20.16||||0.004|TWO_SIDED|95.0|-33.88|-6.44|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||-6.44|-33.88|0.004
71799283|NCT02665481|143098098|SUPERIORITY||Mean Difference (Final Values)|3.04||||0.58|TWO_SIDED|95.0|-7.76|13.85|||Marginal Model|||Time x Exercise (Month 0 and Month 6)||13.85|-7.76|0.58
71674727|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|7.8||||0.1534|TWO_SIDED|90.0|-3.4|20.9|||Chan and Zhang method|||Week 8||20.9|-3.4|0.1534
71674728|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.4||||0.4867|TWO_SIDED|90.0|-10.0|11.4|||Chan and Zhang method|||Week 8||11.4|-10.0|0.4867
71674729|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|12.3||||0.0435|TWO_SIDED|90.0|0.4|25.9|||Chan and Zhang method|||Week 8||25.9|0.4|0.0435
71674730|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-2.9||||0.6349|TWO_SIDED|90.0|-14.8|8.4|||Chan and Zhang method|||Week 10||8.4|-14.8|0.6349
71674731|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-0.2||||0.4565|TWO_SIDED|90.0|-12.6|12.5|||Chan and Zhang method|||Week 10||12.5|-12.6|0.4565
71674732|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.0||||0.5|TWO_SIDED|90.0|-12.5|12.5|||Chan and Zhang method|||Week 10||12.5|-12.5|0.5000
71674733|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|7.9||||0.1765|TWO_SIDED|90.0|-5.7|21.8|||Chan and Zhang method|||Week 10||21.8|-5.7|0.1765
71799284|NCT02665481|143098098|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.37|TWO_SIDED|95.0|-19.98|7.46|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||7.46|-19.98|0.37
71799285|NCT02665481|143098099|SUPERIORITY||Mean Difference (Final Values)|22.71||||0.33|TWO_SIDED|95.0|-22.95|68.36|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||68.36|-22.95|0.33
71799286|NCT02665481|143098099|SUPERIORITY||Mean Difference (Final Values)|25.35||||0.31|TWO_SIDED|95.0|-23.18|73.88|||Marginal Model|||Time x MBSR (Month 0 and Month 18)||73.88|-23.18|0.31
71799287|NCT02665481|143098099|SUPERIORITY||Mean Difference (Final Values)|-17.18||||0.46|TWO_SIDED|95.0|-62.83|28.48|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||28.48|-62.83|0.46
71799288|NCT02665481|143098099|SUPERIORITY||Mean Difference (Final Values)|21.11||||0.39|TWO_SIDED|95.0|-27.41|69.64|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||69.64|-27.41|0.39
71799289|NCT02665481|143098100|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.37|TWO_SIDED|95.0|-0.02|0.01|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||0.01|-0.02|0.37
71799290|NCT02665481|143098100|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.1|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.00|-0.02|0.10
71799291|NCT02665481|143098100|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.21|TWO_SIDED|95.0|-0.004|0.02|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.02|-0.004|0.21
71799292|NCT02665481|143098100|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.09|TWO_SIDED|95.0|-0.02|0.0|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.00|-0.02|0.09
71799293|NCT02665481|143098101|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.57|TWO_SIDED|95.0|-0.38|0.69|||Marginal Model|||Time x MBSR (Month 0 and Month 6)||0.69|-0.38|0.57
71799294|NCT02665481|143098101|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.58|0.55|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||0.55|-0.58|0.96
71799295|NCT02665481|143098101|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.37|TWO_SIDED|95.0|-0.78|0.29|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.29|-0.78|0.37
71799296|NCT02665481|143098101|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-0.57|0.57|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||0.57|-0.57|0.99
71799297|NCT02665481|143098102|SUPERIORITY||Mean Difference (Final Values)|0.93||||0.19|TWO_SIDED|95.0|-0.47|2.33|||Marginal Model|||Time x MBSR (Month 0 and Month 6).||2.33|-0.47|0.19
71799298|NCT02665481|143098102|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.09|TWO_SIDED|95.0|-0.19|2.77|||Marginal Model|||Time x MBSR (Month 0 and Month 18).||2.77|-0.19|0.09
71799299|NCT02665481|143098102|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.42|TWO_SIDED|95.0|-1.97|0.83|||Marginal Model|||Time x Exercise (Month 0 and Month 6).||0.83|-1.97|0.42
71799300|NCT02665481|143098102|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.54|TWO_SIDED|95.0|-1.01|1.94|||Marginal Model|||Time x Exercise (Month 0 and Month 18).||1.94|-1.01|0.54
71799301|NCT02896127|143098168|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.65|3.69|||Regression, Logistic||||"PTFU=post-treatment follow-up (12 weeks after last study treatment)~95% confidence intervals are from a score method with continuity correction."|3.69|1.65|<.0001
71799302|NCT03354429|143098176|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.015|TWO_SIDED|95.0|0.71|0.96||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.96|0.71|0.015
71799303|NCT03354429|143098177|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.004|TWO_SIDED|95.0|0.68|0.93||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Cox||Placebo is the reference group (denominator)|||0.93|0.68|0.004
71799304|NCT03354429|143098178|SUPERIORITY||Odds Ratio (OR)|0.98||||0.613|TWO_SIDED|95.0|0.89|1.07||The hypothesis was tested at the 4.996% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence was used to address the issue of multiple testing|Regression, Logistic|NIHSS (National Institutes of Health Stroke Scale) score and history of stroke (yes/no) included as covariates|Placebo is the reference group (denominator)|||1.07|0.89|0.613
71799305|NCT03354429|143098179|OTHER||Hazard Ratio (HR)|3.99||||0.001|TWO_SIDED|95.0|1.74|9.14|||Regression, Cox||Placebo is the reference group (denominator)|||9.14|1.74|0.001
71799306|NCT03354429|143098180|OTHER||Hazard Ratio (HR)|3.66||||0.005|TWO_SIDED|95.0|1.48|9.02|||Regression, Cox||Placebo is the reference group (denominator)|||9.02|1.48|0.005
71799307|NCT03354429|143098181|OTHER||Hazard Ratio (HR)|3.27|||<|0.001|TWO_SIDED|95.0|1.67|6.43|||Regression, Cox||Placebo is the reference group (denominator)|||6.43|1.67|<0.001
71799308|NCT03354429|143098182|OTHER||Hazard Ratio (HR)|4.8|||<|0.001|TWO_SIDED|95.0|3.28|7.02|||Regression, Cox||Placebo is the reference group (denominator)|||7.02|3.28|<0.001
71893455|NCT01380899|143308068|SUPERIORITY|IHC analyses revealed intense α-synuclein positive immunostaining in PD patients, showing small nodular deposits from 1 to 2 μm in diameter in the SCL of the epidermis including the epidermal component adjacent to hair follicles, and in cells from PSUs, while control subjects presented null immunoreaction. The α-synuclein inclusions in the two groups of patients were morphologically similar but quantitatively different. These inclusions appeared to be juxtanuclear.|Median Difference (Net)|57.9|STANDARD_DEVIATION|8.85|<|0.01|TWO_SIDED|95.0|44.9|62.6||The presence of alpha-synuclein aggregates expressed as % of cells with inclusions was tested for normality (Shapiro-Wilk test). Then, with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests (software Statistica 7.0 at 95% confidence).|Kruskal-Wallis|The groups were analyzed with Kruskal-Wallis followed by Mann-Whitney U tests.|The expression of the abnormal protein (alpha-synuclein) must be different between the three groups (PD, AP, and control)|The patients were stratified according to the clinical diagnosis made on the basis of the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal a-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test.|The patients were stratified according to the clinical diagnosis based on the clinical findings, the MRI, and the progression of the disease. Both the clinical diagnosis and the semiquantitative histological analysis were carried out independently and blind to each other. The presence of aggregates of abnormal α-synuclein, expressed as the percentage of cells with positive inclusions in each experimental group, was tested for normality with the Shapiro-Wilk test. Next, the groups were analyzed with the nonparametric Kruskal-Wallis followed by Mann-Whitney U tests. One independent analysis was performed for each structure, namely the epidermis, PSU, and EG. Assessments were performed using the software Statistica 7.0 (Tulsa, OK) at 95% confidence.|62.6|44.9|< 0.01
71799309|NCT01513291|143098223|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.33153|TWO_SIDED|95.0|-1.3|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.3|0.33153
71799310|NCT01513291|143098224|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|-3.4|21.6|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||21.6|-3.4|
71674734|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|0.3||||0.5013|TWO_SIDED|90.0|-14.0|15.2|||Chan and Zhang method|||Week 10||15.2|-14.0|0.5013
71799311|NCT01513291|143098225|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-4.0|8.9|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen \& Nurminen method|||8.9|-4.0|
71799312|NCT01513291|143098226|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.24008|TWO_SIDED|95.0|-1.4|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, \>8) as covariates|||0.4|-1.4|0.24008
71799313|NCT01513291|143098227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.43093|TWO_SIDED|95.0|0.7|2.0|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period 1 (≤8, \>8) as covariates.|||2.0|0.7|0.43093
71799314|NCT01513291|143098228|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9737|TWO_SIDED|95.0|0.7|1.5|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Treatment Period 1 (≤8, \>8) as covariates.|||1.5|0.7|0.97370
71799315|NCT03732638|143098229|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0099|TWO_SIDED|95.0|-1.46|-0.2|||Mixed Models Analysis|||||-0.20|-1.46|0.0099
71799316|NCT03732638|143098230|SUPERIORITY||Risk Difference (RD)|7.6||||0.0438|TWO_SIDED|95.0|0.2|14.9|||Cochran-Mantel-Haenszel|||||14.9|0.2|0.0438
71799317|NCT03732638|143098231|SUPERIORITY||Mean Difference (Net)|-0.8||||0.0017|TWO_SIDED|95.0|-1.34|-0.31|||Mixed Models Analysis|||||-0.31|-1.34|0.0017
71799318|NCT03732638|143098232|SUPERIORITY||Mean Difference (Net)|-0.2||||0.3868|TWO_SIDED|95.0|-0.8|0.31||P-value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Mixed Models Analysis|||||0.31|-0.80|0.3868
71674735|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-7.8||||0.7969|TWO_SIDED|90.0|-20.7|5.9|||Chan and Zhang method|||Week 10||5.9|-20.7|0.7969
71799319|NCT01034397|143098257|SUPERIORITY_OR_OTHER|||||||1||||||Wrist region: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
71799320|NCT01034397|143098257|SUPERIORITY_OR_OTHER|||||||0.026||||||2nd and 5th MCP joints: Tocilizumab versus placebo|t-test, 1 sided|||||||0.026
71799321|NCT01034397|143098257|SUPERIORITY_OR_OTHER|||||||1||||||Total synovitis score: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
71799322|NCT01034397|143098258|SUPERIORITY_OR_OTHER|||||||0.421||||||Percentage Change in OMERACT RAMRIS global score; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.421
71799323|NCT01034397|143098259|SUPERIORITY_OR_OTHER|||||||0.434||||||Absolute change in OMERACT RAMRIS global score; Placebo versus Tocilizumab|t-test, 1 sided|||||||0.434
71799324|NCT01034397|143098262|SUPERIORITY_OR_OTHER|||||||1||||||Change in Wrist region; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
71799325|NCT01034397|143098262|SUPERIORITY_OR_OTHER|||||||0.065||||||Change in 2nd to 5th MCP; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.065
71799326|NCT01034397|143098262|SUPERIORITY_OR_OTHER|||||||1||||||Change in Total synovitis; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
71799327|NCT01034397|143098264|SUPERIORITY_OR_OTHER|||||||1||||||Absolute Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
71799328|NCT01034397|143098265|SUPERIORITY_OR_OTHER|||||||1||||||Percentage Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided|||||||1.00
71799329|NCT01034397|143098268|SUPERIORITY_OR_OTHER|||||||0.266||||||Percentage Change in Bone oedema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.266
71799330|NCT01034397|143098269|SUPERIORITY_OR_OTHER|||||||0.337||||||Absolute Change in Bone edema; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.337
71799331|NCT01034397|143098272|SUPERIORITY_OR_OTHER|||||||0.114||||||Percentage change in DCE-MRI EER (global); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.114
71799332|NCT01034397|143098273|SUPERIORITY_OR_OTHER|||||||0.239||||||Absolute Change in DCE-MRI EER; Tocilizumab versus placebo.|t-test, 1 sided|||||||0.239
71896312|NCT03114969|143314790|SUPERIORITY||Odds Ratio (OR)|2.477||||0.007|TWO_SIDED|95.0|1.274|4.815||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||4.815|1.274|0.007
71674736|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|-3.2||||0.6424|TWO_SIDED|90.0|-16.4|10.6|||Chan and Zhang method|||Week 10||10.6|-16.4|0.6424
71799333|NCT01034397|143098276|SUPERIORITY_OR_OTHER|||||||0.271||||||Percentage change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.271
71799334|NCT01034397|143098277|SUPERIORITY_OR_OTHER|||||||0.37||||||Absolute change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided|||||||0.370
71799335|NCT01034397|143098280|SUPERIORITY_OR_OTHER|||||||1||||||Percentage and absolute change in DCE-MRI EER (wrist); Placebo versus Tocilizumab|t-test, 1 sided|||||||1.00
71799336|NCT01034397|143098285|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71799337|NCT01034397|143098288|SUPERIORITY_OR_OTHER|||||||0.067|||||||t-test, 1 sided|||||||0.067
71799338|NCT01034397|143098290|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
71799339|NCT01034397|143098292|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
71799340|NCT01034397|143098294|SUPERIORITY_OR_OTHER||||||<|0.001||||||Change from Baseline to Week 12|Friedman's T test|||||||<0.001
71799341|NCT01034397|143098294|SUPERIORITY_OR_OTHER|||||||0.5||||||Change from Baseline to Week 12|Friedman's T test|||||||0.500
71799342|NCT01034397|143098295|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 1 sided|||||||0.007
71799343|NCT01034397|143098298|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
71799344|NCT01034397|143098300|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 1 sided|||||||0.002
71799345|NCT01034397|143098302|SUPERIORITY_OR_OTHER|||||||0.118|||||||t-test, 1 sided|||||||0.118
71799346|NCT01034397|143098304|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
71799347|NCT01034397|143098306|SUPERIORITY_OR_OTHER|||||||0.437|||||||t-test, 1 sided|||||||0.437
71799348|NCT01034397|143098307|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 1 sided|||||||1.00
71799349|NCT01034397|143098310|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 1 sided|||||||0.190
71799350|NCT01034397|143098312|SUPERIORITY_OR_OTHER|||||||0.051|||||||t-test, 1 sided|||||||0.051
71799351|NCT01018264|143098314|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.2||||0.53|TWO_SIDED||||||ANCOVA|Adjusted for baseline value|This represents the effect size between solifenacin and placebo.|||||0.53
71799352|NCT01018264|143098315|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.53||||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
71799353|NCT01018264|143098316|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.35||||0.22|TWO_SIDED||||||ANCOVA|||||||0.22
71799354|NCT01018264|143098317|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.27||||0.47|TWO_SIDED||||||ANCOVA|||||||0.47
71799355|NCT01018264|143098318|SUPERIORITY_OR_OTHER_LEGACY||Effect size|0.11||||0.94|TWO_SIDED||||||ANCOVA|||||||0.94
71799356|NCT03915548|143098325|OTHER|Group by time interaction (difference in trajectory)||||||0.54||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,747)=0.88|||.54
71896313|NCT03114969|143314790|SUPERIORITY||Odds Ratio (OR)|2.748||||0.006|TWO_SIDED|95.0|1.328|5.683||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||5.683|1.328|0.006
71674737|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
71674738|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|2.8||||0.3402|TWO_SIDED|90.0|-7.0|13.4|||Chan and Zhang method|||Week 14||13.4|-7.0|0.3402
71674739|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.8||||0.1743|TWO_SIDED|90.0|-4.5|17.6|||Chan and Zhang method|||Week 14||17.6|-4.5|0.1743
71674740|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|10.7||||0.062|TWO_SIDED|90.0|-0.7|23.6|||Chan and Zhang method|||Week 14||23.6|-0.7|0.0620
71799357|NCT03915548|143098326|OTHER|Group by time interaction (difference in trajectory)||||||0.09||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,746.4)=2.64|||.09
71799358|NCT03915548|143098327|OTHER|Group by time interaction (difference in trajectory)||||||0.55||||||Adjusted|Mixed Models Analysis|Poisson model with log link; multiple-degree-of-freedom test|||F(3,717)=0.7|||.55
71799359|NCT03915548|143098328|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Adjusted|Mixed Models Analysis|multiple-degree-of-freedom test|||F(3,394.7)=0.18|||.99
71799360|NCT03915548|143098329|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Overall score adjusted P = 0.99 Physical subscale adjusted P = 0.99 Social subscale adjusted P = 0.99 Emotional subscale adjusted P = 0.99 Functional subscale adjusted P = 0.99|Mixed Models Analysis|multiple-degree-of-freedom test|||"Group by time interaction:~Overall score: F(3,731.3)=0.03 Physical subscale: F(3,744.5)=0.23 Social subscale: F(3,740.6)=0.32 Emotional subscale: F(3,743)=0.46 Functional subscale: F(3,746.1)=0.3"|||0.99
71799361|NCT03915548|143098330|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Active coping adjusted P = 0.99 Planning adjusted P = 0.21 Positive reframing adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Active planning: F(3,746)=0.8 Planning: F(3,744.8)=2.93 Positive reframing = F(3,742)=0.21|||0.99
71799362|NCT03915548|143098331|OTHER|Group by time interaction (difference in trajectory)||||||0.02|||||||Mixed Models Analysis|multiple-degrees-of-freedom test|||Disengagement: F(3,741.2)=5.09 Reengagement: F(3,745.7)=0.81|||0.02
71799363|NCT03915548|143098332|OTHER|Group by time interaction (difference in trajectory)||||||0.99||||||Anxiety adjusted P = 0.99 Depression adjusted P = 0.99|Mixed Models Analysis|multiple-degrees-of-freedom test|||Anxiety: F(3,737.5)=0.17 Depression: F(3,733.6)=0.85|||0.99
71799364|NCT03915548|143098333|SUPERIORITY||Cohen's d|0.26||||0.09|TWO_SIDED|95.0|-0.01|0.54||Importance subscale: Adjusted P = .09 Performance subscale: Adjusted P = \<.001 Satisfaction subscale: Adjusted P = \<.001|Mixed Models Analysis|multiple-degrees-of-freedom test|Importance subscale: Cohen's d = 0.26 (-.01, 0.54) Performance subscale: Cohen's d = 0.60 (0.32, 0.87) Satisfaction subscale: Cohen's d = 0.76 (0.48, 1.02)|||0.54|-.01|.09
71840890|NCT04800211|143190999|EQUIVALENCE|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)|Mean Difference (Net)|-0.344||||0.0776|TWO_SIDED|95.0|-0.725|0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Test 2 on Visit 7. Alternate hypothesis: Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Test 2 on Visit 7. (mITT Population)||0.038|-0.725|0.0776
71674741|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|2.6||||0.3534|TWO_SIDED|90.0|-7.8|15.4|||Chan and Zhang method|||Week 14||15.4|-7.8|0.3534
71799365|NCT03217136|143098334|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|18.1|||||TWO_SIDED|95.0|-2.6|41.1||||||Difference in Percentage (C/T+MTZ minus MERO)||41.1|-2.6|
71799366|NCT03217136|143098335|OTHER|The Miettinen \& Nurminen method was used.|Difference in Percentage|2.9|||||TWO_SIDED|95.0|-12.9|9.9||||||Difference in Percentage (C/T+MTZ minus MERO)||9.9|-12.9|
71893456|NCT00473694|143308073|SUPERIORITY||Estimated Treatment Effect|17.29|||<|0.0001|TWO_SIDED|95.0|13.95|21.42||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.42|13.95|<0.0001
71674742|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.5||||0.2508|TWO_SIDED|90.0|-5.5|18.8|||Chan and Zhang method|||Week 14||18.8|-5.5|0.2508
71674743|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|1.9||||0.4238|TWO_SIDED|90.0|-8.2|13.6|||Chan and Zhang method|||Week 14||13.6|-8.2|0.4238
71674744|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|5.9||||0.2696|TWO_SIDED|90.0|-6.2|19.3|||Chan and Zhang method|||Week 16||19.3|-6.2|0.2696
71674745|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|3.0||||0.3648|TWO_SIDED|90.0|-8.6|15.3|||Chan and Zhang method|||Week 16||15.3|-8.6|0.3648
71674746|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|8.7||||0.1267|TWO_SIDED|90.0|-3.8|22.2|||Chan and Zhang method|||Week 16||22.2|-3.8|0.1267
71674747|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|10.7||||0.0832|TWO_SIDED|90.0|-2.5|24.4|||Chan and Zhang method|||Week 16||24.4|-2.5|0.0832
71674748|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|6.5||||0.2099|TWO_SIDED|90.0|-5.7|21.3|||Chan and Zhang method|||Week 16||21.3|-5.7|0.2099
71674749|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|3.6||||0.3474|TWO_SIDED|90.0|-8.0|17.4|||Chan and Zhang method|||Week 16||17.4|-8.0|0.3474
71674750|NCT03850483|142867388|SUPERIORITY||Risk Difference (RD)|8.1||||0.2124|TWO_SIDED|90.0|-4.0|21.6|||Chan and Zhang method|||Week 16||21.6|-4.0|0.2124
71799367|NCT03217136|143098336|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-14.3|||||TWO_SIDED|95.0|-26.67|4.93||||||Difference in Percentage (C/T+MTZ minus MERO)||4.93|-26.67|
71799368|NCT03217136|143098337|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-19.1|||||TWO_SIDED|95.0|-30.18|-2.89||||||Difference in Percentage (C/T+MTZ minus MERO)||-2.89|-30.18|
71799369|NCT03217136|143098338|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-11.2|||||TWO_SIDED|95.0|-23.66|9.61||||||Difference in Percentage (C/T+MTZ minus MERO)||9.61|-23.66|
71893457|NCT00473694|143308074|SUPERIORITY||Estimated Treatment Effect|14.86|||<|0.0001|TWO_SIDED|95.0|10.18|21.67||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.67|10.18|<0.0001
71799370|NCT03217136|143098339|OTHER|The difference in percentage was based on the Miettinen \& Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Difference in Percentage|-16.3|||||TWO_SIDED|95.0|-27.59|1.39||||||Difference in Percentage (C/T+MTZ minus MERO)||1.39|-27.59|
71799371|NCT03192150|143098340|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was two-sided and performed using a significance (alpha) level of 0.05.|||||<|0.0001||||||P-values were from a Chi-Square test (with continuity correction) of differences between treatments in the proportion of participants with ACC Grade 0 who did not receive rescue medication versus all other grades combined.|Chi-squared, Corrected|A Fisher's exact test was used if 1 or more of the cells had an expected frequency of ≤ 5.||||||< 0.0001
71799372|NCT03192150|143098341|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.311||||0.0054|TWO_SIDED|95.0|1.311|4.074||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 1||4.074|1.311|0.0054
71799373|NCT03192150|143098341|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.581|||<|0.0001|TWO_SIDED|95.0|1.967|6.519||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 8||6.519|1.967|< 0.0001
71799374|NCT03192150|143098341|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.503|||<|0.0001|TWO_SIDED|95.0|1.909|6.426||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 15||6.426|1.909|< 0.0001
71799375|NCT03192150|143098341|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|3.659|||<|0.0001|TWO_SIDED|95.0|1.987|6.736||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 18||6.736|1.987|< 0.0001
71799376|NCT03192150|143098341|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoints were two-sided and performed using a significance (alpha) level of 0.05.|Odds Ratio (OR)|2.952||||0.0008|TWO_SIDED|95.0|1.596|5.462||P-values were from a Chi-Square test with continuity correction.|Chi-squared, Corrected|A Fisher's exact test was used if ≥ 1 of the cells had an expected frequency of ≤ 5.||Statistical analysis of proportion of participants who achieved a pain score of 0 on the VAS on Day 29||5.462|1.596|0.0008
71799377|NCT05446909|143098350|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
71799378|NCT05446909|143098351|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
71799379|NCT05446909|143098352|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
71799380|NCT05446909|143098353|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71799381|NCT05446909|143098354|SUPERIORITY|||||||0.754|||||||ANOVA|||||||0.754
71799382|NCT05446909|143098355|SUPERIORITY|||||||0.985|||||||ANOVA|||||||0.985
71799383|NCT05446909|143098356|SUPERIORITY|||||||0.877|||||||ANOVA|||||||0.877
71893458|NCT00473694|143308075|SUPERIORITY||Estimated Treatment Effect|15.84|||<|0.0001|TWO_SIDED|95.0|12.58|19.95||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||19.95|12.58|<0.0001
71799384|NCT00261716|143098377|SUPERIORITY_OR_OTHER|||||||0.33|||||||Chi-squared|1 degree of freedom||Intent to treat analysis||||.33
71799385|NCT00261716|143098378|SUPERIORITY_OR_OTHER|||||||0.75|||||||t-test, 2 sided|degrees of freedom=36||intent to treat analysis||||.75
71799386|NCT00261716|143098379|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|degrees of freedom=17||||||.41
71799387|NCT00261716|143098380|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|Fishers exact= 1.0; one degree of freedom||intent to treat --all participants who obtained at least one job||||>.05
71799388|NCT00261716|143098380|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>.05
71799389|NCT00261716|143098381|SUPERIORITY_OR_OTHER|||||||0.37|||||||Mixed Models Analysis|employment status effect- F(1,12)=..85||Intent to treat analysis||||.37
71799390|NCT00261716|143098381|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|time effect F(1,54)=.2.05||||||.16
71799391|NCT00261716|143098381|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|employment status X time effect F (1,54)=.. 24||||||.63
71799392|NCT00261716|143098382|SUPERIORITY_OR_OTHER|||||||0.62|||||||Mixed Models Analysis|employment status effect F(1,12)=.26||intent to treat analysis||||.62
71799393|NCT00261716|143098382|SUPERIORITY_OR_OTHER|||||||0.65|||||||Mixed Models Analysis|time effect F (1,58)=.21 ,.||||||.65
71674751|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|13.7||||0.0544|TWO_SIDED|90.0|-0.3|27.9|||Chan and Zhang method|||Week 1||27.9|-0.3|0.0544
71799394|NCT00261716|143098382|SUPERIORITY_OR_OTHER|||||||0.81|||||||Mixed Models Analysis|employment status X time effect F(1,58)=.06||||||.81
71799395|NCT00261716|143098383|SUPERIORITY_OR_OTHER|||||||0.19|||||||Mixed Models Analysis|employment status effect F(1,12)=1.95,||Intent to treat analysis||||.19
71799396|NCT00261716|143098383|SUPERIORITY_OR_OTHER|||||||0.09|||||||Mixed Models Analysis|time effect (1.54)=2.99,||||||.09
71799397|NCT00261716|143098383|SUPERIORITY_OR_OTHER|||||||0.39|||||||Mixed Models Analysis|employment status X time effect (F(1,54)=.74||||||.39
71799398|NCT00094653|143098430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0004|TWO_SIDED|95.0|0.55|0.85|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.85|0.55|0.0004
71799399|NCT00094653|143098431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0026|TWO_SIDED|95.0|0.51|0.87|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.87|0.51|0.0026
71893459|NCT00473694|143308076|SUPERIORITY||Estimated Treatment Effect|18.45|||<|0.0001|TWO_SIDED|95.0|13.98|24.35||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.35|13.98|<0.0001
71674752|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|6.1||||0.2697|TWO_SIDED|90.0|-6.3|19.6|||Chan and Zhang method|||Week 1||19.6|-6.3|0.2697
71799400|NCT00094653|143098431|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7575|TWO_SIDED|95.0|0.83|1.3|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.30|0.83|0.7575
71799401|NCT00094653|143098433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
71893460|NCT00473694|143308077|SUPERIORITY||Estimated Treatment Effect|17.04|||<|0.0001|TWO_SIDED|95.0|13.62|21.31||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||21.31|13.62|<0.0001
71674753|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|16.5||||0.0286|TWO_SIDED|90.0|2.0|31.0|||Chan and Zhang method|||Week 1||31.0|2.0|0.0286
71674754|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|7.8||||0.1512|TWO_SIDED|90.0|-4.7|20.8|||Chan and Zhang method|||Week 1||20.8|-4.7|0.1512
71674755|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-7.7||||0.79|TWO_SIDED|90.0|-21.9|7.4|||Chan and Zhang method|||Week 1||7.4|-21.9|0.7900
71674756|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|7.3||||0.3137|TWO_SIDED|90.0|-8.5|24.0|||Chan and Zhang method|||Week 1||24.0|-8.5|0.3137
71674757|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|5.0||||0.3789|TWO_SIDED|90.0|-10.9|22.6|||Chan and Zhang method|||Week 1||22.6|-10.9|0.3789
71799402|NCT00094653|143098433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
71799403|NCT00094653|143098433|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
71799404|NCT00094653|143098435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.00|0.66|
71799405|NCT00094653|143098435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||0.83|0.50|
71799406|NCT00094653|143098435|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).|||1.53|1.01|
71799407|NCT00094653|143098437|SUPERIORITY_OR_OTHER|||||||0.0433||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0433
71799408|NCT00094653|143098437|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0012
71799409|NCT00094653|143098437|SUPERIORITY_OR_OTHER|||||||0.0402||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0402
71799410|NCT00094653|143098440|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0179
71799411|NCT00094653|143098440|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0002
71799412|NCT00094653|143098440|SUPERIORITY_OR_OTHER|||||||0.0429||95.0||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel|||||||0.0429
71840891|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.621||||0.0055|TWO_SIDED|95.0|-1.055|-0.186|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.186|-1.055|0.0055
71840892|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.778||||0.0011|TWO_SIDED|95.0|-1.24|-0.316|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.316|-1.240|0.0011
71893461|NCT00473694|143308078|SUPERIORITY||Estimated Treatment Effect|17.7|||<|0.0001|TWO_SIDED|95.0|12.85|24.38||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.|||24.38|12.85|<0.0001
71893462|NCT00283387|143308163|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
71799413|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.2805|TWO_SIDED|95.0|-2.5|8.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.6|-2.5|0.2805
71799414|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.63|TWO_SIDED|95.0|-5.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||8.2|-5.0|0.6300
71799415|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6026|TWO_SIDED|95.0|-3.9|6.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline||6.8|-3.9|0.6026
71799416|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.1219|TWO_SIDED|95.0|-1.1|8.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||8.9|-1.1|0.1219
71799417|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0||||0.0978|TWO_SIDED|95.0|-0.9|11.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||11.0|-0.9|0.0978
71799418|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.659|TWO_SIDED|95.0|-6.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline||3.8|-6.0|0.6590
71799419|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.248|TWO_SIDED|95.0|-3.0|11.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||11.7|-3.0|0.2480
71799420|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.4742|TWO_SIDED|95.0|-5.6|12.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||12.0|-5.6|0.4742
71799421|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.7597|TWO_SIDED|95.0|-6.1|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline||8.3|-6.1|0.7597
71799422|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9119|TWO_SIDED|95.0|-4.7|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.2|-4.7|0.9119
71674758|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|13.7||||0.0636|TWO_SIDED|90.0|-1.0|28.5|||Chan and Zhang method|||Week 2||28.5|-1.0|0.0636
71674759|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|9.6||||0.1435|TWO_SIDED|90.0|-4.9|24.5|||Chan and Zhang method|||Week 2||24.5|-4.9|0.1435
71799423|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.7616|TWO_SIDED|95.0|-6.9|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||5.0|-6.9|0.7616
71799424|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.6266|TWO_SIDED|95.0|-3.6|6.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline||6.0|-3.6|0.6266
71799425|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9984|TWO_SIDED|95.0|-4.8|4.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||4.8|-4.8|0.9984
71799426|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.4873|TWO_SIDED|95.0|-7.8|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||3.7|-7.8|0.4873
71799427|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.3938|TWO_SIDED|95.0|-2.7|6.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline||6.7|-2.7|0.3938
71799428|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.6695|TWO_SIDED|95.0|-8.1|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||5.2|-8.1|0.6695
71799429|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.4041|TWO_SIDED|95.0|-11.3|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||4.6|-11.3|0.4041
71799430|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.5538|TWO_SIDED|95.0|-4.5|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline||8.3|-4.5|0.5538
71799431|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.2259|TWO_SIDED|95.0|-10.3|2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||2.4|-10.3|0.2259
71799432|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.6168|TWO_SIDED|95.0|-9.6|5.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||5.7|-9.6|0.6168
71799433|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.5329|TWO_SIDED|95.0|-8.2|4.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline||4.3|-8.2|0.5329
71799434|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.9397|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||5.0|-4.7|0.9397
71799435|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.6716|TWO_SIDED|95.0|-7.1|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||4.6|-7.1|0.6716
71799436|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.5497|TWO_SIDED|95.0|-3.3|6.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline||6.2|-3.3|0.5497
71799437|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.0625|TWO_SIDED|95.0|-12.8|0.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||0.3|-12.8|0.0625
71674760|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|25.7||||0.0058|TWO_SIDED|90.0|8.9|42.4|||Chan and Zhang method|||Week 2||42.4|8.9|0.0058
71674761|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|22.9||||0.0112|TWO_SIDED|90.0|6.5|38.9|||Chan and Zhang method|||Week 2||38.9|6.5|0.0112
71674762|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|4.9||||0.3349|TWO_SIDED|90.0|-10.8|21.3|||Chan and Zhang method|||Week 2||21.3|-10.8|0.3349
71674763|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|10.6||||0.2065|TWO_SIDED|90.0|-6.1|27.7|||Chan and Zhang method|||Week 2||27.7|-6.1|0.2065
71799438|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.3214|TWO_SIDED|95.0|-11.9|3.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||3.9|-11.9|0.3214
71799439|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.4898|TWO_SIDED|95.0|-8.7|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline||4.2|-8.7|0.4898
71799440|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.0761|TWO_SIDED|95.0|-11.8|0.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||0.6|-11.8|0.0761
71799441|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.3187|TWO_SIDED|95.0|-11.2|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||3.7|-11.2|0.3187
71799442|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.5548|TWO_SIDED|95.0|-7.9|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline||4.2|-7.9|0.5548
71799443|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.245|TWO_SIDED|95.0|-12.1|3.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||3.1|-12.1|0.2450
71799444|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8464|TWO_SIDED|95.0|-10.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline||8.2|-10.0|0.8464
71799445|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.3351|TWO_SIDED|95.0|-10.9|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep Disturbance change from baseline||3.7|-10.9|0.3351
71799446|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.6291|TWO_SIDED|95.0|-9.1|5.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite loss change from baseline||5.5|-9.1|0.6291
71799447|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.7675|TWO_SIDED|95.0|-7.4|10.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||10.1|-7.4|0.7675
71799448|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.3911|TWO_SIDED|95.0|-10.2|4.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline||4.0|-10.2|0.3911
71893463|NCT02886715|143308176|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.75|||||TWO_SIDED|90.0|94.39|103.31||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.31|94.39|
71893464|NCT02886715|143308176|SUPERIORITY||Mean Difference (Final Values)|-5.17||||0.0185|TWO_SIDED|95.0|-9.46|-0.87|||ANOVA|with treatment and site as fixed effects in the model||||-0.87|-9.46|0.0185
71893465|NCT02886715|143308178|EQUIVALENCE|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.39|||||TWO_SIDED|90.0|93.42|103.61||p-value was no calculated|ANOVA|with treatment and site as fixed effects in the model||||103.61|93.42|
71893466|NCT02886715|143308178|SUPERIORITY||Mean Difference (Final Values)|-4.39||||0.0354|TWO_SIDED|95.0|-8.48|-0.3|||ANOVA|with treatment and site as fixed effects in the model||||-0.30|-8.48|0.0354
71893467|NCT00768560|143308208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.69||||||90.0|-12.62|-6.77|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-6.77|-12.62|
71893468|NCT00768560|143308208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-2.87|2.98|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||2.98|-2.87|
71893469|NCT00768560|143308208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.75||||||90.0|6.83|12.67|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||12.67|6.83|
71893470|NCT00768560|143308208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97||||||90.0|-5.5|-2.44|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||-2.44|-5.50|
71674764|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|11.4||||0.1871|TWO_SIDED|90.0|-5.6|29.1|||Chan and Zhang method|||Week 2||29.1|-5.6|0.1871
71799449|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0431|TWO_SIDED|95.0|-12.9|-0.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-0.2|-12.9|0.0431
71799450|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.0101|TWO_SIDED|95.0|-17.4|-2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||-2.4|-17.4|0.0101
71799451|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.2796|TWO_SIDED|95.0|-2.8|9.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline||9.5|-2.8|0.2796
71799452|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3||||0.194|TWO_SIDED|95.0|-2.2|10.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||10.8|-2.2|0.1940
71799453|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0821|TWO_SIDED|95.0|-0.9|14.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||14.8|-0.9|0.0821
71799454|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.4169|TWO_SIDED|95.0|-9.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline||3.8|-9.0|0.4169
71799455|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.5717|TWO_SIDED|95.0|-7.5|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||4.2|-7.5|0.5717
71799456|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.6949|TWO_SIDED|95.0|-5.6|8.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||8.4|-5.6|0.6949
71799457|NCT00094653|143098442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2849|TWO_SIDED|95.0|-8.8|2.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline||2.6|-8.8|0.2849
71799458|NCT00330551|143098501|SUPERIORITY||t-test|0.77|||=|0.05|TWO_SIDED|95.0|0.483|1.058|||t-test, 2 sided||||t(80)=5.3, p\<.001|1.058|0.483|=.05
71799459|NCT00330551|143098502|SUPERIORITY||Risk Difference (RD)|11.1|||=|0.001|TWO_SIDED||||||Chi-squared|||||||=.001
71799460|NCT00330551|143098503|SUPERIORITY||||||=|0.83|||||||Chi-squared|||||||=.83
71799461|NCT00330551|143098504|SUPERIORITY||||||=|0.2|||||||ANOVA|||A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.||||=.20
71799462|NCT00330551|143098505|SUPERIORITY|||||||0.71|||||||ANOVA|||||||.71
71799463|NCT00330551|143098506|SUPERIORITY||||||=|0.57|||||||ANOVA|||||||=.57
71893471|NCT00768560|143308208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||||90.0|-2.21|0.85|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||0.85|-2.21|
71799464|NCT00330551|143098508|SUPERIORITY||||||<|0.16|||||||ANOVA|||||||<.16
71799465|NCT00330551|143098509|SUPERIORITY||||||=|0.41|||||||ANOVA|||||||=.41
71799466|NCT03120013|143098510|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71799467|NCT03120013|143098511|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71799468|NCT03120013|143098512|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71799469|NCT03120013|143098513|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71799470|NCT03120013|143098514|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71799471|NCT03120013|143098515|SUPERIORITY||||||=|0.006|||||||ANCOVA|||||||=0.006
71799472|NCT03120013|143098516|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71799473|NCT03120013|143098517|SUPERIORITY||||||=|0.043|||||||ANCOVA|||||||=0.043
71799474|NCT03254134|143098566|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.534|0.97||||||There was no formal hypothesis testing.|The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.970|0.534|
71799475|NCT03254134|143098567|SUPERIORITY||Hazard Ratio (HR)|0.549|||||TWO_SIDED|95.0|0.303|0.994||||||There was no formal hypothesis testing.|The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable|0.994|0.303|
71799476|NCT02702401|143098568|SUPERIORITY||Hazard Ratio (HR)|0.775||||0.0186|TWO_SIDED|95.0|0.609|0.987|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.987|0.609|0.0186
71893472|NCT00768560|143308208|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.29||||||90.0|1.76|4.82|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.||4.82|1.76|
71799477|NCT02702401|143098569|SUPERIORITY||Hazard Ratio (HR)|0.781||||0.0238|TWO_SIDED|95.0|0.611|0.998|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.998|0.611|0.0238
71674765|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|13.4||||0.1245|TWO_SIDED|90.0|-4.9|31.4|||Chan and Zhang method|||Week 4||31.4|-4.9|0.1245
71674766|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|14.0||||0.128|TWO_SIDED|90.0|-4.7|33.7|||Chan and Zhang method|||Week 4||33.7|-4.7|0.1280
71674767|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|32.9||||0.003|TWO_SIDED|90.0|12.4|50.5|||Chan and Zhang method|||Week 4||50.5|12.4|0.0030
71674768|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|22.6||||0.0235|TWO_SIDED|90.0|3.1|40.6|||Chan and Zhang method|||Week 4||40.6|3.1|0.0235
71674769|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|4.9||||0.3728|TWO_SIDED|90.0|-13.6|24.1|||Chan and Zhang method|||Week 4||24.1|-13.6|0.3728
71674770|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|25.5||||0.0153|TWO_SIDED|90.0|4.0|43.6|||Chan and Zhang method|||Week 4||43.6|4.0|0.0153
71674771|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|9.4||||0.2543|TWO_SIDED|90.0|-8.8|27.8|||Chan and Zhang method|||Week 4||27.8|-8.8|0.2543
71674772|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|7.9||||0.2785|TWO_SIDED|90.0|-10.2|26.4|||Chan and Zhang method|||Week 6||26.4|-10.2|0.2785
71674773|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|13.3||||0.1434|TWO_SIDED|90.0|-7.4|33.7|||Chan and Zhang method|||Week 6||33.7|-7.4|0.1434
71799478|NCT02702401|143098570|OTHER||Difference in Percent|13.8|||||TWO_SIDED|95.0|7.7|19.5|||||Miettinen \& Nurminen method stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||19.5|7.7|
71799479|NCT02702401|143098572|OTHER||Hazard Ratio (HR)|0.688||||0.0011|TWO_SIDED|95.0|0.54|0.877||One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Log Rank||Cox regression model with Efron's method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level|||0.877|0.540|0.0011
71893473|NCT01021111|143308220|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.||||<0.01
71674774|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|36.1||||0.0015|TWO_SIDED|90.0|12.8|54.1|||Chan and Zhang method|||Week 6||54.1|12.8|0.0015
71674775|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|24.1||||0.0242|TWO_SIDED|90.0|3.4|43.9|||Chan and Zhang method|||Week 6||43.9|3.4|0.0242
71674776|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|35.1||||0.0037|TWO_SIDED|90.0|10.0|54.1|||Chan and Zhang method|||Week 6||54.1|10.0|0.0037
71674777|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|16.6||||0.1037|TWO_SIDED|90.0|-4.9|36.7|||Chan and Zhang method|||Week 6||36.7|-4.9|0.1037
71674778|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|1.8||||0.4607|TWO_SIDED|90.0|-17.7|22.5|||Chan and Zhang method|||Week 6||22.5|-17.7|0.4607
71674779|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|12.2||||0.1725|TWO_SIDED|90.0|-8.0|31.9|||Chan and Zhang method|||Week 8||31.9|-8.0|0.1725
71674780|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|22.8||||0.0451|TWO_SIDED|90.0|0.2|43.6|||Chan and Zhang method|||Week 8||43.6|0.2|0.0451
71674781|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|44.4||||0.0003|TWO_SIDED|90.0|21.3|62.9|||Chan and Zhang method|||Week 8||62.9|21.3|0.0003
71674782|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|26.7||||0.0239|TWO_SIDED|90.0|3.8|47.6|||Chan and Zhang method|||Week 8||47.6|3.8|0.0239
71674783|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|20.8||||0.0643|TWO_SIDED|90.0|-2.1|41.2|||Chan and Zhang method|||Week 8||41.2|-2.1|0.0643
71674784|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-6.0||||0.6676|TWO_SIDED|90.0|-25.9|15.9|||Chan and Zhang method|||Week 8||15.9|-25.9|0.6676
71674785|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|17.6||||0.0898|TWO_SIDED|90.0|-4.2|37.8|||Chan and Zhang method|||Week 8||37.8|-4.2|0.0898
71674786|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|11.8||||0.2707|TWO_SIDED|90.0|-10.1|32.9|||Chan and Zhang method|||Week 10||32.9|-10.1|0.2707
71674787|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|9.0||||0.2981|TWO_SIDED|90.0|-14.2|31.0|||Chan and Zhang method|||Week 10||31.0|-14.2|0.2981
71674788|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|31.0||||0.011|TWO_SIDED|90.0|8.0|51.4|||Chan and Zhang method|||Week 10||51.4|8.0|0.0110
71674789|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|33.3||||0.0083|TWO_SIDED|90.0|9.1|53.2|||Chan and Zhang method|||Week 10||53.2|9.1|0.0083
71674790|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|4.8||||0.4217|TWO_SIDED|90.0|-18.3|27.5|||Chan and Zhang method|||Week 10||27.5|-18.3|0.4217
71674791|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|1.3||||0.5152|TWO_SIDED|90.0|-20.8|23.2|||Chan and Zhang method|||Week 10||23.2|-20.8|0.5152
71799480|NCT01462357|143098576|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.16|1.15||||||Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.15|-1.16|
71799481|NCT01462357|143098576|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.15|1.14||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||1.14|-1.15|
71674792|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-11.8||||0.7002|TWO_SIDED|90.0|-33.1|11.7|||Chan and Zhang method|||Week 10||11.7|-33.1|0.7002
71674793|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|27.6||||0.0169|TWO_SIDED|90.0|5.2|47.9|||Chan and Zhang method|||Week 12||47.9|5.2|0.0169
71674794|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|25.9||||0.0283|TWO_SIDED|90.0|3.2|46.2|||Chan and Zhang method|||Week 12||46.2|3.2|0.0283
71674795|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|37.9||||0.002|TWO_SIDED|90.0|14.3|57.1|||Chan and Zhang method|||Week 12||57.1|14.3|0.0020
71674796|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|31.4||||0.0095|TWO_SIDED|90.0|8.4|51.5|||Chan and Zhang method|||Week 12||51.5|8.4|0.0095
71674797|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|21.0||||0.0798|TWO_SIDED|90.0|-2.7|42.6|||Chan and Zhang method|||Week 12||42.6|-2.7|0.0798
71799482|NCT01462357|143098577|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||ANOVA|||Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.69|0.54|
71799483|NCT01462357|143098577|NON_INFERIORITY|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.23|||||TWO_SIDED|95.0|0.2|0.26|||ANOVA|||Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.||0.26|0.20|
71799484|NCT01462357|143098578|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.|GMT ratio|4.52||||0.0001|TWO_SIDED|95.0|3.97|5.13|||ANOVA|||Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||5.13|3.97|0.0001
71840893|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.26|-0.54|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.540|-1.260|<.0001
71674798|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|10.9||||0.2848|TWO_SIDED|90.0|-11.3|31.8|||Chan and Zhang method|||Week 12||31.8|-11.3|0.2848
71674799|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|0.5||||0.5062|TWO_SIDED|90.0|-21.1|23.1|||Chan and Zhang method|||Week 12||23.1|-21.1|0.5062
71674800|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|36.9||||0.0012|TWO_SIDED|90.0|16.7|55.3|||Chan and Zhang method|||Week 14||55.3|16.7|0.0012
71674801|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|38.7||||0.0007|TWO_SIDED|90.0|17.3|57.4|||Chan and Zhang method|||Week 14||57.4|17.3|0.0007
71674802|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|47.0||||0.0001|TWO_SIDED|90.0|24.6|65.1|||Chan and Zhang method|||Week 14||65.1|24.6|0.0001
71674803|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|29.9||||0.0039|TWO_SIDED|90.0|9.5|48.7|||Chan and Zhang method|||Week 14||48.7|9.5|0.0039
71674804|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|4.5||||0.3895|TWO_SIDED|90.0|-17.5|26.5|||Chan and Zhang method|||Week 14||26.5|-17.5|0.3895
71674805|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|10.1||||0.2793|TWO_SIDED|90.0|-11.8|31.8|||Chan and Zhang method|||Week 14||31.8|-11.8|0.2793
71674806|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-8.5||||0.7027|TWO_SIDED|90.0|-28.4|12.2|||Chan and Zhang method|||Week 14||12.2|-28.4|0.7027
71674807|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|37.0||||0.0009|TWO_SIDED|90.0|15.4|55.2|||Chan and Zhang method|||Week 16||55.2|15.4|0.0009
71674808|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|23.0||||0.0205|TWO_SIDED|90.0|4.1|43.2|||Chan and Zhang method|||Week 16||43.2|4.1|0.0205
71674809|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|46.8||||0.0001|TWO_SIDED|90.0|24.6|65.7|||Chan and Zhang method|||Week 16||65.7|24.6|0.0001
71674810|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|44.6||||0.0002|TWO_SIDED|90.0|21.5|62.9|||Chan and Zhang method|||Week 16||62.9|21.5|0.0002
71674811|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-18.5||||0.9209|TWO_SIDED|90.0|-38.3|3.2|||Chan and Zhang method|||Week 16||3.2|-38.3|0.9209
71799485|NCT01462357|143098578|SUPERIORITY|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.|GMT ratio|1.69||||0.0001|TWO_SIDED|95.0|1.49|1.91|||ANOVA|||Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.||1.91|1.49|0.0001
71674812|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-13.9||||0.793|TWO_SIDED|90.0|-34.4|8.7|||Chan and Zhang method|||Week 16||8.7|-34.4|0.7930
71674813|NCT03850483|142867389|SUPERIORITY||Risk Difference (RD)|-5.1||||0.6156|TWO_SIDED|90.0|-28.0|20.1|||Chan and Zhang method|||Week 16||20.1|-28.0|0.6156
71674814|NCT00652626|142867441|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|98.4|||||TWO_SIDED|90.0|64.0|151.3|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% confidence interval (CI) of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||151.3|64.0|
71674815|NCT00652626|142867441|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|67.5|||||TWO_SIDED|90.0|44.7|101.8|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||101.8|44.7|
71674816|NCT00652626|142867441|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|82.7|||||TWO_SIDED|90.0|53.8|127.2|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||127.2|53.8|
71674817|NCT00652626|142867442|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|97.4|||||TWO_SIDED|90.0|63.8|148.8|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||148.8|63.8|
71799486|NCT02915744|143098658|OTHER||ESMO-MCBS (v1.0)|1.0|||||TWO_SIDED|||||||||||||
71799487|NCT00813358|143098660|NON_INFERIORITY|NI=7%|KM product-limit estimator|99.1|||||TWO_SIDED|95.0|97.4|100.0||||||||100|97.4|
71799488|NCT03851016|143098695|SUPERIORITY|||||||0.113|||||||Mancova|||"Null hypothesis is that there would be no difference in change of depressive symptoms between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the GDS-12R at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in depressive symptoms."||||.113
71799489|NCT03851016|143098696|SUPERIORITY|||||||0.123|||||||Mancova|||"Null hypothesis is that there would be no difference in change of Presence of Meaning (POM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the POM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in POM."||||.123
71799490|NCT03851016|143098697|SUPERIORITY|||||||0.91|||||||Mancova|||"The null hypothesis is that there would be no difference in change of Search for Meaning (SFM) between Life Story Book Intervention and Usual Care. A multivariate analysis of covariance (MANCOVA) models with the SFM at baseline as the covariate, and the treatment group and study site as factors. The test was performed with a significance level of 0.05.~A sample size of 20 was needed to provide 90% power to detect a 5 point difference in SFM."||||.910
71799491|NCT03337724|143098714|SUPERIORITY||Stratified Hazard Ratio|1.02||||0.9237|TWO_SIDED|95.0|0.71|1.45|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.45|0.71|0.9237
71799492|NCT03337724|143098715|SUPERIORITY||Stratified Hazard Ratio|1.0||||0.9965|TWO_SIDED|95.0|0.71|1.4|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.40|0.71|0.9965
71799493|NCT03337724|143098723|SUPERIORITY||Stratified Hazard Ratio|1.08|||||TWO_SIDED|95.0|0.73|1.58|||||Stratification was done prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, tumor PIK3CA/AKT1/PTEN alteration status (PIK3CA/AKT1-activating mutations vs. PTEN alterations with no PIK3CA/AKT1-activating mutations).|||1.58|0.73|
71799494|NCT03337724|143098723|SUPERIORITY||Stratified Hazard Ratio|0.94|||||TWO_SIDED|95.0|0.65|1.37|||||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).|||1.37|0.65|
71799495|NCT03337724|143098726|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.2162|TWO_SIDED|95.0|0.83|2.22|||Log Rank||Stratification variables were: prior adjuvant/neoadjuvant chemotherapy (yes vs. no), region, prior therapy with a PI3K or mTOR inhibitor (yes vs. no).||Stratified Analysis|2.22|0.83|0.2162
71799496|NCT01660412|143098742|OTHER||Mean Difference (Final Values)|1.42|STANDARD_DEVIATION|2.17|<|0.0001|TWO_SIDED|95.0|0.85|2.0|||t-test, 2 sided|||||2.00|0.85|<0.0001
71799497|NCT00368940|143098744|SUPERIORITY||Cohen D at week 12|0.6||||0.005|TWO_SIDED|95.0|0.13|1.06|||Mixed Models Analysis|||||1.06|0.13|0.005
71799498|NCT00368940|143098745|SUPERIORITY||Cohen D at week 12|0.67||||0.001|TWO_SIDED|95.0|0.2|1.14|||Mixed Models Analysis|||||1.14|0.20|0.001
71799499|NCT00368940|143098746|SUPERIORITY|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||||||0.0268
71799500|NCT00368940|143098747|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71799501|NCT00739336|143098819|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|||Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in -2LL).||||<0.01
71799502|NCT00120042|143098844|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We planned that up to 300 women would be recruited. This sample size would achieve 80% poer at a 5% significance level to detect a reduction from 40% placental retention rate with no specific therapy (Group 1) to 20% with Group 2 or 3. An interim analysis was planned after 240 women had been recruited.||||0.05
71799503|NCT00120042|143098845|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71799504|NCT00436280|143098872|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.512|||||TWO_SIDED|95.0|0.217|1.206|||||Comparing GCB versus non-GCB|Comparing GCB versus non-GCB||1.206|0.217|
71674818|NCT00652626|142867442|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|68.5|||||TWO_SIDED|90.0|45.7|102.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||102.7|45.7|
71674819|NCT00652626|142867442|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|83.2|||||TWO_SIDED|90.0|54.5|127.1|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||127.1|54.5|
71799505|NCT00436280|143098873|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.388|1.989|||||Comparing High Expression versus Low Expression|Comparing High Expression versus Low Expression||1.989|0.388|
71799506|NCT01663259|143098886|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71840894|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.52||||0.015|TWO_SIDED|95.0|-0.938|-0.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.103|-0.938|0.0150
71893474|NCT01021111|143308221|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Pearson|||The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05||||<0.05
71674820|NCT00652626|142867443|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|127.7|||||TWO_SIDED|90.0|66.3|245.7|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||245.7|66.3|
71799507|NCT01663259|143098887|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71799508|NCT01663259|143098888|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71799509|NCT01049919|143098889|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.224|TWO_SIDED|95.0|0.31|1.31|||Proportional Hazards Regression|||||1.31|0.31|0.224
71893475|NCT00389207|143308223|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.016||||0.684||95.0|-0.062|0.095||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)||||0.095|-0.062|0.684
71799510|NCT01049919|143098890|SUPERIORITY|||||||0.671||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.671
71799511|NCT01049919|143098891|SUPERIORITY|||||||0.714||||||Treatment-by-week p-value is reported.|Repeated measures model|The statistical analysis model includes treatment group, week, treatment-by-week, and baseline pain measurement.||||||0.714
71799512|NCT01049919|143098893|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.018|TWO_SIDED|95.0|0.16|0.85|||Proportional Hazards Regression|||||0.85|0.16|0.018
71799513|NCT00673452|143098902|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.||Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of -0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.||||<0.001
71799514|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.19|-0.31||P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.19|<0.001
71893476|NCT00389207|143308223|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.025||||0.584||95.0|-0.065|0.115||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.115|-0.065|0.584
71893477|NCT00389207|143308223|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.009||||0.855||95.0|-0.084|0.101||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||0.101|-0.084|0.855
71840895|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.349||||0.1048|TWO_SIDED|95.0|-0.771|0.074|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.074|-0.771|0.1048
71893478|NCT00389207|143308224|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.038||||0.321||95.0|-0.112|0.037||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.||||0.037|-0.112|0.321
71674821|NCT00652626|142867443|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|84.7|||||TWO_SIDED|90.0|45.3|158.5|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||158.5|45.3|
71799515|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.61||||0.001|TWO_SIDED|95.0|-0.99|-0.24||P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.24|-0.99|0.001
71799516|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.74|||<|0.001|TWO_SIDED|95.0|-1.13|-0.35||P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.35|-1.13|<0.001
71799517|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.2|-0.31||P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.31|-1.20|<0.001
71799518|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.39|-0.49||P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.39|<0.001
71799519|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.41|-0.49||P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.49|-1.41|<0.001
71799520|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.24|-0.36||P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.36|-1.24|<0.001
71799521|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.21|-0.32||P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.21|<0.001
71799522|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.38|-0.52||P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.38|<0.001
71799523|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.39||P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.39|-1.35|<0.001
71799524|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.92|-0.86||P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.86|-1.92|<0.001
71799525|NCT00673452|143098903|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.93|||<|0.001|TWO_SIDED|95.0|-1.33|-0.52||P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.52|-1.33|<0.001
71799526|NCT00673452|143098904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83||||0.005|TWO_SIDED|95.0|-1.41|-0.25||P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.41|0.005
71674822|NCT00652626|142867443|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|107.5|||||TWO_SIDED|90.0|55.9|207.0|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons||207.0|55.9|
71674823|NCT00652626|142867446|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.1|||||TWO_SIDED|90.0|71.2|143.6|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.6|71.2|
71674824|NCT00652626|142867446|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|144.9|||||TWO_SIDED|90.0|103.6|202.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||202.7|103.6|
71674825|NCT00652626|142867446|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|101.4|||||TWO_SIDED|90.0|71.4|143.9|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m\^2 / Azacitidine 25 mg/m\^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m\^2 is the reference group for comparisons.||143.9|71.4|
71674826|NCT00652626|142867449|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|169.3|||||TWO_SIDED|90.0|109.2|262.5|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters"||262.5|109.2|
71674827|NCT00652626|142867449|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|140.4|||||TWO_SIDED|90.0|90.6|217.7|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||217.7|90.6|
71674828|NCT00652626|142867450|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|166.3|||||TWO_SIDED|90.0|108.6|254.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||254.6|108.6|
71674829|NCT00652626|142867450|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.2|||||TWO_SIDED|90.0|92.2|216.2|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||216.2|92.2|
71674830|NCT00652626|142867451|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|141.7|||||TWO_SIDED|90.0|73.2|274.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||274.6|73.2|
71674831|NCT00652626|142867451|SUPERIORITY_OR_OTHER_LEGACY||Ratio (%) of Geometric Means|105.6|||||TWO_SIDED|90.0|54.5|204.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."||204.6|54.5|
71674832|NCT00652626|142867452|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1342|TWO_SIDED|90.0|0.0|0.52|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.||0.52|0|0.1342
71674833|NCT00652626|142867452|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.25||||0.1017|TWO_SIDED|90.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.||0.50|0|0.1017
71799527|NCT00673452|143098904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.013|TWO_SIDED|95.0|-1.3|-0.15||P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.15|-1.30|0.013
71893479|NCT00389207|143308235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.461||||0.0403||95.0|0.22|0.966|||Regression, Cox|||||0.966|0.220|0.0403
71799528|NCT00673452|143098904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92||||0.003|TWO_SIDED|95.0|-1.52|-0.32||P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.52|0.003
71799529|NCT00673452|143098904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88||||0.005|TWO_SIDED|95.0|-1.49|-0.26||P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.26|-1.49|0.005
71799530|NCT00673452|143098904|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.94|||<|0.001|TWO_SIDED|95.0|-1.49|-0.38||P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.38|-1.49|<0.001
71799531|NCT00673452|143098905|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.89||||0.007|TWO_SIDED|95.0|-3.25|-0.53||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.53|-3.25|0.007
71799532|NCT00673452|143098906|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.51|-0.16||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.16|-0.51|<0.001
71799533|NCT00673452|143098907|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07||||0.907|TWO_SIDED|95.0|-1.13|1.27||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.27|-1.13|0.907
71799534|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.22||||0.003|TWO_SIDED|95.0|1.76|8.67||P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.67|1.76|0.003
71799535|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.42|||<|0.001|TWO_SIDED|95.0|3.41|9.43||P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||9.43|3.41|<0.001
71799536|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.44|||<|0.001|TWO_SIDED|95.0|4.41|10.47||P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.47|4.41|<0.001
71799537|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47||||0.002|TWO_SIDED|95.0|2.06|8.88||P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.88|2.06|0.002
71799538|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.78||||0.004|TWO_SIDED|95.0|3.11|16.45||P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||16.45|3.11|0.004
71799539|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.59||||0.632|TWO_SIDED|95.0|-4.93|8.11||P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||8.11|-4.93|0.632
71799540|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.67|||<|0.001|TWO_SIDED|95.0|2.73|10.61||P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||10.61|2.73|<0.001
71799541|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.31||||0.015|TWO_SIDED|95.0|0.84|7.79||P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||7.79|0.84|0.015
71799542|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.14||||0.134|TWO_SIDED|95.0|-0.35|2.64||P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||2.64|-0.35|0.134
71799543|NCT00673452|143098908|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.83|||<|0.001|TWO_SIDED|95.0|2.05|5.6||P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||5.60|2.05|<0.001
71799544|NCT00673452|143098909|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96||||0.083|TWO_SIDED|95.0|-2.05|0.13||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||0.13|-2.05|0.083
71799545|NCT00673452|143098910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-1.18|-0.32||P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.32|-1.18|<0.001
71799546|NCT00673452|143098910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.003|TWO_SIDED|95.0|-1.05|-0.22||P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.22|-1.05|0.003
71799547|NCT00673452|143098910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72||||0.003|TWO_SIDED|95.0|-1.19|-0.25||P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.25|-1.19|0.003
71799548|NCT00673452|143098910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.05|TWO_SIDED|95.0|-0.97|0.0||P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.00|-0.97|0.050
71799549|NCT00673452|143098910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.43|-1.32|<0.001
71799550|NCT00673452|143098911|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.002
71799551|NCT00673452|143098912|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||0.003
71799552|NCT00673452|143098913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.82||||0.084|TWO_SIDED|95.0|-0.25|3.88||P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.88|-0.25|0.084
71799553|NCT00673452|143098913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52||||0.434|TWO_SIDED|95.0|-0.79|1.84||P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||1.84|-0.79|0.434
71799554|NCT00673452|143098914|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96||||0.003|TWO_SIDED|95.0|0.67|3.26||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||3.26|0.67|0.003
71799555|NCT00673452|143098915|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.|Fisher Exact|||||||1.00
71799556|NCT00673452|143098916|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.21|-0.45||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.|||-0.45|-1.21|<0.001
71799557|NCT03969212|143098950|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.68|||=|0.013|TWO_SIDED|95.38|0.5|0.93|||GEE|||The odds ratio (OR) shown represents the odds of Baloxavir Marboxil (BMX) versus the odds of Placebo.||0.93|0.50|= 0.013
71799558|NCT03969212|143098951|SUPERIORITY||Adjusted OR (BMX vs Placebo)|0.75|||=|0.155|TWO_SIDED|95.38|0.5|1.12|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.12|0.50|= 0.1550
71799559|NCT03969212|143098952|OTHER||Odds Ratio (BMX vs Placebo}]|0.76|||||TWO_SIDED|95.38|0.55|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.55|
71799560|NCT03969212|143098953|OTHER||Odds Ratio (BMX vs Placebo)|0.69|||||TWO_SIDED|95.38|0.46|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.46|
71799561|NCT03969212|143098954|OTHER||Adjusted OR (BMX vs Placebo)|0.66|||||TWO_SIDED|95.38|0.48|0.91|||GEE model|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.91|0.48|
71799562|NCT03969212|143098955|OTHER||Adjusted OR (BMX vs Placebo)|0.73|||||TWO_SIDED|95.38|0.48|1.09|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.09|0.48|
71799563|NCT03969212|143098956|OTHER||Adjusted OR (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.53|0.94|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||0.94|0.53|
71799564|NCT03969212|143098957|OTHER||Odds Ratio (BMX vs Placebo)|0.79|||||TWO_SIDED|95.38|0.59|1.06||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.06|0.59|
71799565|NCT03969212|143098958|OTHER||Adjusted OR (BMX vs Placebo)|0.72|||||TWO_SIDED|95.38|0.49|1.07|||Two-Sided P-value|||The OR shown represents the odds of BMX versus the odds of Placebo.||1.07|0.49|
71799566|NCT03969212|143098959|OTHER||Odds Ratio (BMX vs Placebo)|0.71|||||TWO_SIDED|95.38|0.48|1.04||||||The OR shown represents the odds of BMX versus the odds of Placebo.||1.04|0.48|
71893480|NCT00389207|143308239|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.097||||0.0109||95.0|-0.171|-0.022||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients||||-0.022|-0.171|0.0109
71674834|NCT02898597|142867463|SUPERIORITY||Odds Ratio (OR)|12.31|||<|0.05|TWO_SIDED|95.0|1.37|110.3|||Regression, Logistic|||||110.30|1.37|< 0.05
71674835|NCT02898597|142867463|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).||||<0.05
71674836|NCT01234870|142867476|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality||||<0.001
71674837|NCT01262287|142867500|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
71674838|NCT01262287|142867501|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
71674839|NCT01262287|142867501|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.9
71674840|NCT01637922|142867512|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|118.12|STANDARD_DEVIATION|15.4||0.1638|TWO_SIDED|90.0|107.06|130.32||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||130.32|107.06|0.1638
71674841|NCT01637922|142867513|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|114.08|STANDARD_DEVIATION|13.2||0.0391|TWO_SIDED|90.0|104.812|124.164||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||124.164|104.812|0.0391
71674842|NCT01637922|142867514|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.79|STANDARD_DEVIATION|18.7||0.0603|TWO_SIDED|90.0|99.243|125.922||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1||125.922|99.243|0.0603
71799567|NCT03773757|143098975|SUPERIORITY|Longitudinal measures of NPI-Q patient over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8719|||||||Mixed Models Analysis|||||||0.8719
71799568|NCT03773757|143098976|SUPERIORITY|Longitudinal measures of SM-EOLD over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.8389|||||||Mixed Models Analysis|||||||0.8389
71799569|NCT03773757|143098977|SUPERIORITY|Longitudinal measures of PHQ-8 over 24 months were compared between the two groups using mixed effects model that included a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.3431|||||||Mixed Models Analysis|||||||0.3431
71799570|NCT03773757|143098978|SUPERIORITY|Longitudinal measures of NPI-Q caregiver distress over 24 months were compared between the two groups using mixed effects model including a group indicator variable, time since baseline, and an interaction between group and time as independent variables. Unstructured variance-covariance matrix was used to adjust for within-subject correlations over time. Predicted differences in mean scores between the two groups at each time point were estimated using the contrast procedures in the mixed model.||||||0.6612|||||||Mixed Models Analysis|||||||0.6612
71799571|NCT03773757|143098979|SUPERIORITY|A zero-inflated Poisson (ZIP) model was used to compare the mean numbers of hospitalization/ED events between the two groups. The ZIP model consists of a combination of a standard Poisson distribution for count data and a binary logistic regression model to account for additional zero events exceeding what would be expected from an underlying Poisson distribution.||||||0.0007|||||||Zero-Inflated Poisson Regression Model|||||||0.0007
71799572|NCT01147653|143098980|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.72|TWO_SIDED|95.0|-2.6|3.7|||t-test, 2 sided|||H0: The true mean 1-year change in GMFM-66 is the same on Autologous Umbilical Cord Blood and Placebo||3.7|-2.6|0.72
71893481|NCT00389207|143308239|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.072||||0.1033||95.0|-0.158|0.015||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||0.015|-0.158|0.1033
71674843|NCT01637922|142867515|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|117.65|STANDARD_DEVIATION|15.0||0.1424|TWO_SIDED|90.0|106.89|129.5||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||129.50|106.89|0.1424
71799573|NCT01147653|143098981|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71799574|NCT01147653|143098982|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.473
71799575|NCT01147653|143098982|SUPERIORITY|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Bodily Pain/Discomfort change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.377
71799576|NCT01147653|143098982|SUPERIORITY|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Family Cohesion change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.844
71799577|NCT01147653|143098982|SUPERIORITY|||||||0.322|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.322
71799578|NCT01147653|143098982|SUPERIORITY|||||||0.927|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Health Perceptions change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.927
71799579|NCT01147653|143098982|SUPERIORITY|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Global Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.199
71799580|NCT01147653|143098982|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Growth and Development change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.294
71799581|NCT01147653|143098982|SUPERIORITY|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Overall Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.726
71799582|NCT01147653|143098982|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Emotional change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.315
71799583|NCT01147653|143098982|SUPERIORITY|||||||0.396|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Time change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.396
71799584|NCT01147653|143098982|SUPERIORITY|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Physical Abilities change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.381
71799585|NCT01147653|143098982|SUPERIORITY|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Temperament and Moods change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.869
71799586|NCT01147653|143098983|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||H0: The 12 month Access to Services change score is identically distributed in patients assigned Autologous Cord Blood Reinfusion First and Placebo First.||||0.055
71799587|NCT01147653|143098983|SUPERIORITY|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Emotional Well Being and Self Esteem change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.121
71799588|NCT01147653|143098983|SUPERIORITY|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Family Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.647
71799589|NCT01147653|143098983|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Functioning change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.170
71799590|NCT01147653|143098983|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Pain and Impact of Disability change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.410
71799591|NCT01147653|143098983|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Participation and Physical Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.200
71799592|NCT01147653|143098983|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Social wellbeing and acceptance change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.||||0.225
71799593|NCT01147653|143098986|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.290
71799594|NCT01147653|143098989|SUPERIORITY|||||||0.697|||||||t-test, 2 sided|||||||0.697
71799595|NCT01147653|143098990|SUPERIORITY|||||||0.912|||||||t-test, 2 sided|||||||0.912
71799596|NCT01147653|143098991|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
71799597|NCT01147653|143098992|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71799598|NCT01147653|143098993|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71799599|NCT01147653|143098994|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
71799600|NCT01147653|143098995|SUPERIORITY|||||||0.099|||||||t-test, 2 sided|||||||0.099
71799601|NCT01147653|143098996|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
71799602|NCT01147653|143098997|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
71799603|NCT01147653|143098998|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71799604|NCT01147653|143098999|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.310
71799605|NCT01147653|143099001|SUPERIORITY|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of Modified Ashworth Scale scores is the same at 1-year post-infusion with autologous cord blood and placebo.||||0.233
71799606|NCT01147653|143099005|SUPERIORITY|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
71799607|NCT01147653|143099006|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low and High doses of autologous umbilical cord blood.||||0.05
71799608|NCT01147653|143099006|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with High doses of autologous umbilical cord blood and Placebo.||||0.15
71799609|NCT01147653|143099006|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low doses of autologous umbilical cord blood and placebo.||||0.21
71799610|NCT01147653|143099007|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of differences between observed and expected GMFM-66 change scores at 1-year post-infusion is the same for patients receiving Low and High doses of autologous umbilical cord blood.||||<0.01
71799611|NCT01147653|143099008|SUPERIORITY|H0: The population distribution of the Peabody Gross Motor Quotient change score 1 year post-infusion with autologous umbilical cord blood is the same in patients receiving a Low infused dose and a High infused dose.||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71674844|NCT01637922|142867516|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.46|STANDARD_DEVIATION|16.3||0.0367|TWO_SIDED|90.0|100.42|123.715||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||123.715|100.420|0.0367
71799612|NCT01147653|143099009|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.04|TWO_SIDED|95.0|0.01|0.38|||Wilcoxon (Mann-Whitney)|||H0: The true mean 1-year change in normalized whole brain connectivity is the same in patients infused with Low and High doses of autologous umbilical cord blood.||0.38|0.01|0.04
71799613|NCT00280566|143099010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Log Rank|alpha = 0.05 level of significance||Equality of Survival Curves across the treatment groups.||||0.0104
71799614|NCT00280566|143099011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047|||||||Log Rank|No adjustment made for multiple comparisons||alpha = 0.05 level of significance||||0.0047
71799615|NCT00280566|143099012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205||||||No adjustment made for multiple comparisons|Log Rank|||alpha = 0.05 level of significance||||0.0205
71799616|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.55||0.1247|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1247
71799617|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7515|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7515
71799618|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.62||0.3074|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3074
71799619|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.0758|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0758
71799620|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.82||0.0162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0162
71799621|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|0.83||0.0003|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0003
71799622|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.98||0.0242|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0242
71799623|NCT00280566|143099013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.71||0.0161|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0161
71893482|NCT00389207|143308239|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.122||||0.0073||95.0|-0.212|-0.033||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.033|-0.212|0.0073
71799624|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.09||0.0088|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0088
71799625|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3677|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3677
71893483|NCT00389207|143308240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.117||||0.0031||95.0|-0.194|-0.04||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.||||-0.040|-0.194|0.0031
71674845|NCT01637922|142867517|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.52|STANDARD_DEVIATION|17.7||0.0488|TWO_SIDED|90.0|99.577|124.888||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1||124.888|99.577|0.0488
71674846|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.01098|||||TWO_SIDED|95.0|-0.189801|0.16864||||||Pearson correlation of trough concentrations of R-methadone and OOWS||0.168640|-0.189801|
71674847|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.10188|||||TWO_SIDED|95.0|-0.287471|0.092062||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS||0.092062|-0.287471|
71674848|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03198|||||TWO_SIDED|95.0|-0.209893|0.148238||||||Pearson correlation of trough concentrations of S-methadone and OOWS||0.148238|-0.209893|
71799626|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.1||0.0734|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0734
71893484|NCT00389207|143308240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.096||||0.0365||95.0|-0.186|-0.006||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.||||-0.006|-0.186|0.0365
71674849|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0026|||||TWO_SIDED|95.0|-0.189172|0.194156||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS||0.194156|-0.189172|
71674850|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.03364|||||TWO_SIDED|95.0|-0.214505|0.149733||||||Pearson correlation of trough concentrations of Buprenorphine and OOWS||0.149733|-0.214505|
71674851|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.14703|||||TWO_SIDED|95.0|-0.404929|0.135425||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS||0.135425|-0.404929|
71674852|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05431|||||TWO_SIDED|95.0|-0.240578|0.136305||||||Pearson correlation of trough concentrations of norbuprenorphine and OOWS||0.136305|-0.240578|
71674853|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.09727|||||TWO_SIDED|95.0|-0.344024|0.163687||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS||0.163687|-0.344024|
71674854|NCT01637922|142867518|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.36105|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and OOWS||||
71674855|NCT01637922|142867519|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.71|STANDARD_DEVIATION|36.1||0.1642|TWO_SIDED|90.0|85.14|138.8||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||138.80|85.14|0.1642
71674856|NCT01637922|142867520|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|92.43|STANDARD_DEVIATION|33.7||0.142|TWO_SIDED|90.0|73.48|116.27||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||116.27|73.48|0.1420
71674857|NCT01637922|142867521|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.36|STANDARD_DEVIATION|38.1||0.1915|TWO_SIDED|90.0|81.611|143.883||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1||143.883|81.611|0.1915
71674858|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04783|||||TWO_SIDED|95.0|-0.13275|0.224946||||||Pearson correlation of trough concentrations of R-methadone and SOWS||0.224946|-0.132750|
71674859|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.39865|||||TWO_SIDED|95.0|-0.547072|-0.222288||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS||-0.222288|-0.547072|
71674860|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.11175|||||TWO_SIDED|95.0|-0.069336|0.284848||||||Pearson correlation of trough concentrations of S-methadone and SOWS||0.284848|-0.069336|
71674861|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.16815|||||TWO_SIDED|95.0|-0.34787|0.025107||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS||0.025107|-0.347870|
71799627|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9166|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9166
71799628|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.13||0.2791|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2791
71799629|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.146|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1460
71799630|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.7301|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7301
71799631|NCT00280566|143099014|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8162
71799632|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0013
71799633|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.1167|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1167
71799634|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0188|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0188
71799635|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.16||0.3413|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3413
71799636|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.276|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2760
71799637|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.0085|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0085
71799638|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.18||0.1317|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1317
71799639|NCT00280566|143099015|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.18||0.1666|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1666
71799640|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.75||0.0023|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0023
71799641|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.91||0.1412|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.1412
71840896|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.846|||<|0.0001|TWO_SIDED|95.0|-1.185|-0.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.507|-1.185|<.0001
71840897|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.873|||<|0.0001|TWO_SIDED|95.0|-1.127|-0.619|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.619|-1.127|<.0001
71799642|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.87||0.0861|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0861
71799643|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.82||0.5992|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5992
71799644|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.76||0.5873|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5873
71799645|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.78||0.2116|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2116
71799646|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1847|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1847
71799647|NCT00280566|143099016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.82||0.9972|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9972
71799648|NCT00280566|143099017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.93||0.5954|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5954
71799649|NCT00280566|143099017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.93||0.3414|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3414
71799650|NCT00280566|143099017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|1.23||0.9745|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate||||0.9745
71799651|NCT00280566|143099017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.47||0.5627|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5627
71799652|NCT00280566|143099017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|1.1||0.741|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.7410
71840898|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.247||||0.2525|TWO_SIDED|95.0|-0.178|0.671|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.671|-0.178|0.2525
71840899|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.098||||0.6503|TWO_SIDED|95.0|-0.33|0.527|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.527|-0.330|0.6503
71799653|NCT00280566|143099017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.88||0.9632|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9632
71799654|NCT00280566|143099018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.22||0.9538|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9538
71799655|NCT00280566|143099018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.25||0.8541|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8541
71799656|NCT00280566|143099018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.32||0.1084|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1084
71893485|NCT00389207|143308240|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.139||||0.0033||95.0|-0.231|-0.046||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.||||-0.046|-0.231|0.0033
71893486|NCT00389207|143308243|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.001||||0.9784|TWO_SIDED|95.0|-0.065|0.066|||Cochran Chi-Squared|||week 48||0.066|-0.065|0.9784
71799657|NCT00280566|143099018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.27||0.038|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0380
71893487|NCT00389207|143308243|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.064||||0.0331|TWO_SIDED|95.0|0.005|0.123|||Cochran Chi-Squared|||week 96||0.123|0.005|0.0331
71893488|NCT00389207|143308243|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.058||||0.0691|TWO_SIDED|95.0|-0.005|0.121|||Cochran Chi-Squared|||week 144||0.121|-0.005|0.0691
71893489|NCT00389207|143308243|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|-0.023||||0.4585|TWO_SIDED|95.0|-0.084|0.038|||Cochran Chi-Squared|||week 48||0.038|-0.084|0.4585
71893490|NCT00389207|143308243|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.015||||0.5438|TWO_SIDED|95.0|-0.034|0.064|||Cochran Chi-Squared|||week 96||0.064|-0.034|0.5438
71799658|NCT00280566|143099018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2649|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2649
71799659|NCT00280566|143099018|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.27||0.2394|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.2394
71799660|NCT00280566|143099019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.29||0.8117|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.8117
71799661|NCT00280566|143099019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.26||0.0443|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.0443
71799662|NCT00280566|143099019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.28||0.3039|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.3039
71799663|NCT00280566|143099019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.46||0.9953|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.9953
71799664|NCT00280566|143099019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.32||0.1653|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.1653
71799665|NCT00280566|143099019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.32||0.5771|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.||||0.5771
71799666|NCT01109316|143099024|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.48|||||TWO_SIDED|95.0|0.2|0.76|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.|This was the primary gated analysis.||0.76|0.20|
71799667|NCT01109316|143099025|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.22|||||TWO_SIDED|95.0|-0.07|0.52|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.52|-0.07|
71799668|NCT01109316|143099025|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.25|||||TWO_SIDED|95.0|-0.05|0.56|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.|||0.56|-0.05|
71799669|NCT01109316|143099026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|||||TWO_SIDED|95.0|-0.29|0.51|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.51|-0.29|
71799670|NCT01109316|143099026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|||||TWO_SIDED|95.0|-0.41|0.73|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.73|-0.41|
71799671|NCT01109316|143099026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|||||TWO_SIDED|95.0|-0.18|0.24|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.24|-0.18|
71799672|NCT01109316|143099026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|||||TWO_SIDED|95.0|-0.56|0.27|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.27|-0.56|
71799673|NCT01109316|143099026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.48|0.6|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.60|-0.48|
71799674|NCT01109316|143099026|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|||||TWO_SIDED|95.0|-0.85|0.65|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.|||0.65|-0.85|
71893491|NCT00389207|143308243|NON_INFERIORITY_OR_EQUIVALENCE|H0: Difference in proportions = 0|Difference in proportions|0.016||||0.5659|TWO_SIDED|95.0|-0.039|0.071|||Cochran Chi-Squared|||week 144||0.071|-0.039|0.5659
71893492|NCT00389207|143308244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0002||95.0|0.57|0.839|||Regression, Cox|||||0.839|0.570|0.0002
71674862|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.0126|||||TWO_SIDED|95.0|-0.17016|0.194417||||||Pearson correlation of trough concentrations of Buprenorphine and SOWS||0.194417|-0.170160|
71674863|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.02352|||||TWO_SIDED|95.0|-0.253932|0.29696||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS||0.296960|-0.253932|
71674864|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|-0.05787|||||TWO_SIDED|95.0|-0.24392|0.132819||||||Pearson correlation of trough concentrations of norbuprenorphine and SOWS||0.132819|-0.243920|
71674865|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.04052|||||TWO_SIDED|95.0|-0.218159|0.293233||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS||0.293233|-0.218159|
71674866|NCT01637922|142867522|SUPERIORITY_OR_OTHER||Pearson Correlation Coefficient|0.92231|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and SOWS||||
71674867|NCT01637922|142867523|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|138.0|STANDARD_DEVIATION|50.7||0.6889|TWO_SIDED|90.0|97.2|195.92||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||195.92|97.20|0.6889
71799675|NCT01109316|143099027|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|||||TWO_SIDED|95.0|-0.02|0.14|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.14|-0.02|
71799676|NCT01109316|143099027|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|||||TWO_SIDED|95.0|0.01|0.18|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.|||0.18|0.01|
71799677|NCT01109316|143099028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.5|1.75|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.75|0.50|
71799678|NCT01109316|143099028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.29|1.67|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.67|0.29|
71799679|NCT01109316|143099028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.41|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.|||1.41|0.56|
71799680|NCT01109316|143099028|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.66|1.64|||||Odds Ratio of HbA1c \<7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.|||1.64|0.66|
71799681|NCT01109316|143099029|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
71799682|NCT01109316|143099030|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.164
71674868|NCT01637922|142867524|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|132.86|STANDARD_DEVIATION|51.1||0.6188|TWO_SIDED|90.0|93.32|189.16||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||189.16|93.32|0.6188
71674869|NCT01637922|142867525|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|112.03|STANDARD_DEVIATION|52.5||0.3152|TWO_SIDED|90.0|74.85|167.67||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1||167.67|74.85|0.3152
71674870|NCT01637922|142867526|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|98.94|STANDARD_DEVIATION|19.6||0.0107|TWO_SIDED|90.0|85.81|114.076||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.076|85.810|0.0107
71799683|NCT01109316|143099030|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test|||||||0.185
71799684|NCT01109316|143099031|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.736
71799685|NCT01109316|143099031|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.006
71799686|NCT01109316|143099031|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||1.00
71799687|NCT01109316|143099031|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test|||||||0.017
71799688|NCT01109316|143099032|SUPERIORITY_OR_OTHER|||||||0.471||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.471
71799689|NCT01109316|143099032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
71840900|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.239||||0.1759|TWO_SIDED|95.0|-0.109|0.588|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.588|-0.109|0.1759
71893493|NCT00389207|143308244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001||95.0|0.519|0.764|||Regression, Cox|||Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)||0.764|0.519|<0.0001
71893494|NCT00389207|143308245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.1329||95.0|0.535|1.086|||Regression, Cox|||||1.086|0.535|0.1329
71799690|NCT01109316|143099032|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.737
71799691|NCT01109316|143099032|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||<0.001
71799692|NCT01109316|143099034|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.006
71799693|NCT01109316|143099034|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test|||||||0.002
71799694|NCT01109316|143099035|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.060
71799695|NCT01109316|143099035|SUPERIORITY_OR_OTHER|||||||0.486||95.0||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model|||||||0.486
71799696|NCT01109316|143099036|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.056
71799697|NCT01109316|143099036|SUPERIORITY_OR_OTHER|||||||0.805||95.0||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model|||||||0.805
71799698|NCT01109316|143099036|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.020
71799699|NCT01109316|143099036|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model|||||||0.051
71799700|NCT01302392|143099044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.4172|TWO_SIDED|95.0|0.76|1.249||Based on 1-sided test.|Log Rank|Analysis was stratified by the number of previous therapies (3 vs 4 vs ≥ 5) and geographical region (Europe vs. non-Europe)||||1.249|0.760|0.4172
71799701|NCT01702233|143099062|NON_INFERIORITY_OR_EQUIVALENCE|All statistical analyses were of exploratory nature. A one-sided test of non-inferiority of Traumeel®S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval . The non-inferiority margin was set to 13 mm on a 0-100 mm VAS scale.|Mean Difference (Final Values)|13.0|STANDARD_DEVIATION|13.0|<|0.05|ONE_SIDED|95.0||97.5|||ANCOVA|||||97.5||<0.05
71799702|NCT04646616|143099094|NON_INFERIORITY|This is a single-group, of outcome measured at baseline and at 3 months. We hypothesized there would be an improvement or sustainability of the protective behaviours.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.28|TWO_SIDED|95.0|-0.12|0.39|||t-test, 2 sided|||This is a single-group study. Selected outcomes were measured at baseline (first interaction with the community popular opinion leader (POL) and 3 months after.||0.39|-0.12|0.28
71799703|NCT04646616|143099095|OTHER|Test of proportions|difference in proportion|-0.007|STANDARD_ERROR_OF_MEAN|0.04||0.85|TWO_SIDED|95.0|-0.08|0.07|||Test of proportions|||Two sample test of proportions, testing whether the proportion of participants who lack health access at baseline and 3 months is equal (null hypothesis)||0.07|-0.08|0.85
71799704|NCT04646616|143099096|OTHER|Test of proportions.|difference in proportion|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.19|TWO_SIDED|95.0|-0.04|0.19|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who had a SAVAME factor at baseline and 3 months is equal (null hypothesis)||0.19|-0.04|0.19
71799705|NCT04646616|143099097|OTHER|Test of proportions.|difference in proportion|0.067|STANDARD_ERROR_OF_MEAN|0.06||0.23|TWO_SIDED|95.0|-0.04|0.18|||Test of proportions|||Test of proportions. Testing whether the proportion of participants who lack access to SAVAME related services at baseline and 3 months is equal (null hypothesis)||0.18|-0.04|0.23
71799706|NCT03049813|143099098|SUPERIORITY|||||||0.027||||||One-sided p value|Regression, Logistic|Adjusted for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms - anergia||||||0.027
71799707|NCT03049813|143099098|SUPERIORITY|||||||0.0765||||||1-sided p-value|Chi-squared|||||||0.0765
71799708|NCT03049813|143099099|SUPERIORITY|||||||0.062||||||One-sided p value|Regression, Cox|Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, and negative symptoms anergia||||||0.062
71799709|NCT03049813|143099100|SUPERIORITY|||||||0.006||||||Adjusting for baseline year of study participation, problematic substance use, social cognition, community functioning, negative symptoms - anergia|Regression, Linear|||||||0.006
71799710|NCT03049813|143099101|SUPERIORITY|||||||0.013||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One-sided p value.|Regression, Linear|||||||0.013
71799711|NCT03049813|143099102|SUPERIORITY|||||||0.019||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia). One sided p-value.|Regression, Linear|||||||0.019
71799712|NCT03049813|143099103|SUPERIORITY|||||||0.692||||||Mixed-effects linear regression models. Covariates include: baseline year, problematic substance use, social cognition, community functioning, and negative symptoms (anergia).|Regression, Linear|||For this analysis, only participants who completed both pre-test and posttest were included. If someone completed a pre-test SSPA, but not a posttest SSPA, they were not included in the analysis.||||0.692
71799713|NCT01813019|143099105|SUPERIORITY_OR_OTHER|||||||0.671|||||||Mixed Models Analysis|||||||0.671
71799714|NCT01339390|143099124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3941|STANDARD_ERROR_OF_MEAN|0.5759||0.4937|TWO_SIDED|95.0|-0.7347|1.5229||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.5229|-.7347|0.4937
71799715|NCT01339390|143099124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5893|STANDARD_ERROR_OF_MEAN|0.5759||0.3062|TWO_SIDED|95.0|-0.5395|1.7181||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups||1.7181|-0.5395|0.3062
71799716|NCT04847674|143099125|OTHER||LS mean difference|-0.027||||0.7914|TWO_SIDED|95.0|-0.2276|0.174|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1740|-0.2276|0.7914
71799717|NCT04847674|143099125|OTHER||LS mean difference|-0.011||||0.9115|TWO_SIDED|95.0|-0.2126|0.19|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1900|-0.2126|0.9115
71799718|NCT04847674|143099127|OTHER||LS mean difference|0.026||||0.6001|TWO_SIDED|95.0|-0.0733|0.1261|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1261|-0.0733|0.6001
71893495|NCT00389207|143308246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731||||0.0444||95.0|0.539|0.992|||Regression, Cox|||||0.992|0.539|0.0444
71799719|NCT04847674|143099127|OTHER||LS mean difference|0.027||||0.5922|TWO_SIDED|95.0|-0.0732|0.1276|||Mixed Models Analysis||Change from baseline in FEV1 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1276|-0.0732|0.5922
71799720|NCT04847674|143099127|OTHER||LS mean difference|0.027||||0.6017|TWO_SIDED|95.0|-0.0744|0.1277|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1277|-0.0744|0.6017
71799721|NCT04847674|143099127|OTHER||LS mean difference|0.022||||0.6664|TWO_SIDED|95.0|-0.0796|0.1239|||Mixed Models Analysis||Change from baseline in FEV1 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1239|-0.0796|0.6664
71799722|NCT04847674|143099128|OTHER||Hodges-Lehmann (HL) estimator|0.4||||0.7261|TWO_SIDED|95.0|-2.33|3.31|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.31|-2.33|0.7261
71799723|NCT04847674|143099128|OTHER||HL estimator|-0.5||||0.765|TWO_SIDED|95.0|-3.56|3.32|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.32|-3.56|0.7650
71799724|NCT04847674|143099128|OTHER||HL estimator|0.2||||0.7942|TWO_SIDED|95.0|-2.44|3.04|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||3.04|-2.44|0.7942
71799725|NCT04847674|143099128|OTHER||HL estimator|-0.8||||0.6147|TWO_SIDED|95.0|-3.81|2.55|||Wilcoxon (Mann-Whitney)||Change from baseline in weekly average of rescue medication use over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using Wilcoxon rank-sum test stratified on randomization stratification factors.||2.55|-3.81|0.6147
71799726|NCT04847674|143099130|OTHER||LS mean difference|-0.083||||0.4394|TWO_SIDED|95.0|-0.2971|0.1301|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1301|-0.2971|0.4394
71799727|NCT04847674|143099130|OTHER||LS mean difference|-0.089||||0.4051|TWO_SIDED|95.0|-0.302|0.1231|||Mixed Models Analysis|||Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEV1 as a covariate.||0.1231|-0.3020|0.4051
71799728|NCT04847674|143099133|OTHER||LS mean difference|0.093||||0.3485|TWO_SIDED|95.0|-0.1031|0.2893|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2893|-0.1031|0.3485
71799729|NCT04847674|143099133|OTHER||LS mean difference|0.033||||0.7432|TWO_SIDED|95.0|-0.1644|0.2296|||Mixed Models Analysis||Change from baseline in FEF25-75 over 12 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2296|-0.1644|0.7432
71799730|NCT04847674|143099133|OTHER||LS mean difference|0.087||||0.4014|TWO_SIDED|95.0|-0.118|0.292|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2920|-0.1180|0.4014
71799731|NCT04847674|143099133|OTHER||LS mean difference|0.01||||0.9259|TWO_SIDED|95.0|-0.196|0.2153|||Mixed Models Analysis||Change from baseline in FEF25-75 over 16 weeks: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline FEF25-75 as a covariate.||0.2153|-0.1960|0.9259
71799732|NCT04847674|143099135|OTHER||LS mean difference|0.0||||0.9829|TWO_SIDED|95.0|-0.43|0.42|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.42|-0.43|0.9829
71799733|NCT04847674|143099135|OTHER||LS mean difference|0.1||||0.6302|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.52|-0.32|0.6302
71799734|NCT04847674|143099135|OTHER||LS mean difference|-0.1||||0.6707|TWO_SIDED|95.0|-0.54|0.35|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.35|-0.54|0.6707
71799735|NCT04847674|143099135|OTHER||LS mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.44|0.43|||Mixed Models Analysis||Change from baseline in ACQ-6 at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACQ-6 as a covariate.||0.43|-0.44|0.9940
71799736|NCT04847674|143099136|OTHER||LS mean difference|-0.7||||0.4683|TWO_SIDED|95.0|-2.71|1.26|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.26|-2.71|0.4683
71799737|NCT04847674|143099136|OTHER||LS mean difference|-1.2||||0.2239|TWO_SIDED|95.0|-3.16|0.75|||Mixed Models Analysis||Change from baseline in ACT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||0.75|-3.16|0.2239
71799738|NCT04847674|143099136|OTHER||LS mean difference|-0.6||||0.5389|TWO_SIDED|95.0|-2.51|1.32|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.32|-2.51|0.5389
71799739|NCT04847674|143099136|OTHER||LS mean difference|-0.9||||0.3564|TWO_SIDED|95.0|-2.75|1.0|||Mixed Models Analysis||Change from baseline in ACT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline ACT as a covariate.||1.00|-2.75|0.3564
71799740|NCT04847674|143099137|OTHER||LS mean difference|-0.2||||0.4436|TWO_SIDED|95.0|-0.62|0.27|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.27|-0.62|0.4436
71799741|NCT04847674|143099137|OTHER||LS mean difference|-0.1||||0.597|TWO_SIDED|95.0|-0.56|0.32|||Mixed Models Analysis||Change from baseline in AQLQT at Week 12: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.32|-0.56|0.5970
71799742|NCT04847674|143099137|OTHER||LS mean difference|-0.2||||0.3769|TWO_SIDED|95.0|-0.68|0.26|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose A versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.26|-0.68|0.3769
71799743|NCT04847674|143099137|OTHER||LS mean difference|-0.2||||0.4595|TWO_SIDED|95.0|-0.64|0.29|||Mixed Models Analysis||Change from baseline in AQLQT at Week 16: TEV-53275 Dose B versus Placebo|Analysis was performed using an MMRM with treatment group, week, randomization factors, and treatment group by week interaction as fixed effects, and baseline AQLQ as a covariate.||0.29|-0.64|0.4595
71799744|NCT00247728|143099186|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.072||95.0|||||Chi-squared|||||||0.072
71799745|NCT00247728|143099186|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size is based on the paper 'Two-stage selection and testing design for comparative clinical trials', Thall, PF, Simon, R and Ellenberg, SS. Biometrika (1988),75,(2),303-310.||||||0.298||95.0|||||Chi-squared|||||||0.298
71799746|NCT00247728|143099187|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.087||95.0|||||Mantel Haenszel|||||||0.087
71799747|NCT00247728|143099187|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.653||95.0|||||Mantel Haenszel|||||||0.653
71799748|NCT04292730|143099192|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0174|TWO_SIDED|95.0|1.092|2.483||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||2.483|1.092|0.0174
71799749|NCT04292730|143099192|SUPERIORITY||Odds Ratio (OR)|1.31||||0.1826|TWO_SIDED|95.0|0.88|1.952||P-value was calculated using proportional odds model with treatment as the independent variable.|Proportional odds model|||Primary analysis||1.952|0.880|0.1826
71799750|NCT04292730|143099192|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0168|TWO_SIDED|95.0|1.095|2.497||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||2.497|1.095|0.0168
71799751|NCT04292730|143099192|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2186|TWO_SIDED|95.0|0.862|1.917||P-value was calculated using proportional odds model with treatment as the independent variable and baseline clinical status as a nominal covariate.|Proportional odds model|||Secondary analysis||1.917|0.862|0.2186
71799752|NCT04292730|143099193|SUPERIORITY||Difference in the Percentages|4.8||||0.3633|TWO_SIDED|95.0|-5.2|14.7||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||14.7|-5.2|0.3633
71799753|NCT04292730|143099193|SUPERIORITY||Difference in the Percentages|12.0||||0.0201|TWO_SIDED|95.0|1.6|21.8||P-value was calculated from the Fisher exact test to compare each RDV group and the SOC group.|Fisher Exact|||||21.8|1.6|0.0201
71799754|NCT03551210|143099213|NON_INFERIORITY|The non-inferiority bound was designated at the level of -15%|Difference in percentage|6.1|||||TWO_SIDED|95.0|-0.7|13.0||||||||13.0|-0.7|
71799755|NCT03551210|143099213|OTHER||Odds Ratio (OR)|1.45|||=|0.499|TWO_SIDED|95.0|0.49|4.29|||Regression, Logistic|||||4.29|0.49|=0.499
71799756|NCT03551210|143099214|OTHER||Difference in percentage|4.3|||=|0.08|TWO_SIDED|95.0|-0.6|9.7|||Barnard's test|||Visit 2||9.7|-0.6|=0.08
71799757|NCT03551210|143099214|OTHER||Difference in percentage|3.7|||=|0.246|TWO_SIDED|95.0|-2.0|9.8|||Barnard's test|||Visit 3||9.8|-2.0|=0.246
71799758|NCT03551210|143099215|OTHER||||||=|0.154|||||||Barnard test|||||||=0.154
71840901|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.867||||0.0293|TWO_SIDED|95.0|-1.674|-0.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.060|-1.674|0.0293
71799759|NCT03551210|143099216|OTHER||||||=|0.14|||||||Log Rank|||||||=0.14
71799760|NCT03551210|143099217|OTHER||||||=|0.26|||||||Barnard test|||||||=0.26
71799761|NCT03551210|143099218|OTHER||||||=|0.14||||||Visit 2 assessment|Barnard's test|||||||=0.14
71799762|NCT03551210|143099218|OTHER|||||||0.515||||||Visit 3 assessment|Barnard's test|||||||0.515
71799763|NCT03551210|143099218|OTHER|||||||0.515||||||Visit 4 assessment|Barnard's test|||||||0.515
71799764|NCT03238911|143099237|SUPERIORITY||Risk Difference (RD)|-67.0|||<|0.0001|TWO_SIDED|95.0|-77.4|-51.5|||Cochran-Mantel-Haenszel||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."||-51.5|-77.4|<0.0001
71799765|NCT03238911|143099238|SUPERIORITY|||||||0.8979|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) \<2 mg/dL were included.||||0.8979
71799766|NCT03238911|143099239|SUPERIORITY||Risk Difference (RD)|-39.2|||<|0.0001|TWO_SIDED|95.0|-52.2|-23.3|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (\< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.||-23.3|-52.2|<0.0001
71799767|NCT03238911|143099240|SUPERIORITY||Mean Difference (Final Values)|0.48|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.65|0.31|<0.0001
71799768|NCT03238911|143099240|SUPERIORITY||Mean Difference (Final Values)|1.06|||<|0.0001|TWO_SIDED|95.0|0.85|1.27|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.27|0.85|<0.0001
71799769|NCT03238911|143099240|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.81|1.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.25|0.81|<0.0001
71799770|NCT03238911|143099240|SUPERIORITY||Mean Difference (Final Values)|1.35|||<|0.0001|TWO_SIDED|95.0|1.1|1.6|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.60|1.10|<0.0001
71674871|NCT01637922|142867527|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|94.33|STANDARD_DEVIATION|27.6||0.0738|TWO_SIDED|90.0|78.017|114.054||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1||114.054|78.017|0.0738
71674872|NCT00638404|142867529|OTHER|correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|anxiety to evoked pain is 0.24 (P\<.001); anticipated pain to evoked pain is 0.33 (P\<.001); anticipated pain medication to evoked pain is 0.33(P\<.001).||||||<.001
71674873|NCT00638404|142867529|OTHER|correlation of anxiety to evoked pain at 24 hour|||||<|0.001|||||||Spearman Correlation|||||||<.001
71799771|NCT03238911|143099240|SUPERIORITY||Mean Difference (Final Values)|1.03|||<|0.0001|TWO_SIDED|95.0|0.75|1.32|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.32|0.75|<0.0001
71799772|NCT03238911|143099240|SUPERIORITY||Mean Difference (Final Values)|1.13|||<|0.0001|TWO_SIDED|95.0|0.86|1.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.39|0.86|<0.0001
71799773|NCT03238911|143099241|SUPERIORITY||Mean Difference (Final Values)|15.55|||<|0.0001|TWO_SIDED|95.0|10.32|20.79|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||20.79|10.32|<0.0001
71799774|NCT03238911|143099241|SUPERIORITY||Mean Difference (Final Values)|33.23|||<|0.0001|TWO_SIDED|95.0|26.62|39.84|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|26.62|<0.0001
71799775|NCT03238911|143099241|SUPERIORITY||Mean Difference (Final Values)|32.78|||<|0.0001|TWO_SIDED|95.0|25.71|39.84|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||39.84|25.71|<0.0001
71799776|NCT03238911|143099241|SUPERIORITY||Mean Difference (Final Values)|42.11|||<|0.0001|TWO_SIDED|95.0|33.89|50.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||50.32|33.89|<0.0001
71799777|NCT03238911|143099241|SUPERIORITY||Mean Difference (Final Values)|32.28|||<|0.0001|TWO_SIDED|95.0|23.09|41.48|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||41.48|23.09|<0.0001
71799778|NCT03238911|143099241|SUPERIORITY||Mean Difference (Final Values)|36.06|||<|0.0001|TWO_SIDED|95.0|27.33|44.78|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||44.78|27.33|<0.0001
71799779|NCT03238911|143099243|SUPERIORITY||Mean Difference (Final Values)|-105.74|||<|0.0001|TWO_SIDED|95.0|-131.04|-80.45|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-80.45|-131.04|<0.0001
71674874|NCT00638404|142867529|OTHER|correlation of anticipated pain medication 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
71674875|NCT00638404|142867529|OTHER|correlation of anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|||||||<.001
71799780|NCT03238911|143099243|SUPERIORITY||Mean Difference (Final Values)|-60.76|||<|0.0001|TWO_SIDED|95.0|-82.95|-38.58|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-38.58|-82.95|<0.0001
71674876|NCT00638404|142867530|OTHER||||||<|0.001|||||||Spearman Correlation|||preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible||||<.001
71674877|NCT00638404|142867531|OTHER||||||<|0.001|||||||Spearman Correlation|||||||<.001
71799781|NCT03238911|143099243|SUPERIORITY||Mean Difference (Final Values)|-293.23|||<|0.0001|TWO_SIDED|95.0|-368.15|-218.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-218.30|-368.15|<0.0001
71799782|NCT03238911|143099243|SUPERIORITY||Mean Difference (Final Values)|-117.47|||<|0.0001|TWO_SIDED|95.0|-151.6|-83.33|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-83.33|-151.60|<0.0001
71799783|NCT03238911|143099243|SUPERIORITY||Mean Difference (Final Values)|-71.21|||<|0.0001|TWO_SIDED|95.0|-101.8|-40.61|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-40.61|-101.80|<0.0001
71799784|NCT03238911|143099243|SUPERIORITY||Mean Difference (Final Values)|-37.16|||<|0.0001|TWO_SIDED|95.0|-54.92|-19.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-19.39|-54.92|<0.0001
71799785|NCT03238911|143099244|SUPERIORITY||Mean Difference (Final Values)|-99.1|||<|0.0001|TWO_SIDED|95.0|-136.42|-61.76|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-61.76|-136.42|<0.0001
71799786|NCT03238911|143099244|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.0001|TWO_SIDED|95.0|-72.8|-25.9|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-25.90|-72.80|<0.0001
71799787|NCT03238911|143099244|SUPERIORITY||Mean Difference (Final Values)|-191.3|||<|0.0001|TWO_SIDED|95.0|-242.47|-140.09|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-140.09|-242.47|<0.0001
71799788|NCT03238911|143099244|SUPERIORITY||Mean Difference (Final Values)|-100.7|||<|0.0001|TWO_SIDED|95.0|-137.19|-64.2|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-64.20|-137.19|<0.0001
71799789|NCT03238911|143099244|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.0001|TWO_SIDED|95.0|-71.78|-24.96|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-24.96|-71.78|<0.0001
71799790|NCT03238911|143099244|SUPERIORITY||Mean Difference (Final Values)|-15.0||||0.1411|TWO_SIDED|95.0|-35.04|5.06|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.06|-35.04|0.1411
71799791|NCT03238911|143099245|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.562|TWO_SIDED|95.0|-1.08|0.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.59|-1.08|0.5620
71893496|NCT01073943|143308258|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was \>-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was \>0%.|Mean Difference (Net)|3.3|||||ONE_SIDED|97.5|-2.9||||||||||-2.9|
71674878|NCT00638404|142867532|OTHER|Correlation of|||||<|0.001|||||||Spearman Correlation|||||||<.001
71799792|NCT03238911|143099245|SUPERIORITY||Mean Difference (Final Values)|1.75||||0.0126|TWO_SIDED|95.0|0.38|3.12|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|0.38|0.0126
71799793|NCT03238911|143099245|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.608|TWO_SIDED|95.0|-1.19|2.02|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.02|-1.19|0.6080
71799794|NCT03238911|143099245|SUPERIORITY||Mean Difference (Final Values)|2.09||||0.0379|TWO_SIDED|95.0|0.12|4.05|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||4.05|0.12|0.0379
71799795|NCT03238911|143099245|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.2368|TWO_SIDED|95.0|-0.78|3.12|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||3.12|-0.78|0.2368
71799796|NCT03238911|143099245|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.8287|TWO_SIDED|95.0|-2.18|1.75|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.75|-2.18|0.8287
71799797|NCT03238911|143099246|SUPERIORITY||Mean Difference (Final Values)|24.27|||<|0.0001|TWO_SIDED|95.0|18.81|29.73|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||29.73|18.81|<0.0001
71799798|NCT03238911|143099246|SUPERIORITY||Mean Difference (Final Values)|15.75|||<|0.0001|TWO_SIDED|95.0|8.83|22.67|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||22.67|8.83|<0.0001
71799799|NCT03238911|143099246|SUPERIORITY||Mean Difference (Final Values)|20.14|||<|0.0001|TWO_SIDED|95.0|12.07|28.22|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||28.22|12.07|<0.0001
71799800|NCT03238911|143099246|SUPERIORITY||Mean Difference (Final Values)|32.22|||<|0.0001|TWO_SIDED|95.0|25.49|38.96|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||38.96|25.49|<0.0001
71799801|NCT03238911|143099246|SUPERIORITY||Mean Difference (Final Values)|22.87|||<|0.0001|TWO_SIDED|95.0|14.79|30.95|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||30.95|14.79|<0.0001
71840902|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.876||||0.0362|TWO_SIDED|95.0|-1.714|-0.038|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.038|-1.714|0.0362
71674879|NCT02110758|142867544|OTHER|||||||0.025|||||||Regression, Logistic|||To estimate exposure to the intervention on the Access composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.025
71674880|NCT02110758|142867544|OTHER|||||||0.69|||||||Regression, Logistic|||To estimate exposure to the intervention on the Affective Communication composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.69
71674881|NCT02110758|142867544|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Shared Decision-Making composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
71674882|NCT02110758|142867544|OTHER|||||||0.85|||||||Regression, Logistic|||To estimate exposure to the intervention on the Patient Self-Management composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||0.85
71799802|NCT03238911|143099246|SUPERIORITY||Mean Difference (Final Values)|10.6||||0.0043|TWO_SIDED|95.0|3.39|17.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||17.82|3.39|0.0043
71840903|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.139|||<|0.0001|TWO_SIDED|95.0|-1.809|-0.469|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.469|-1.809|<.0001
71840904|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.767||||0.0621|TWO_SIDED|95.0|-1.559|0.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.025|-1.559|0.0621
71674883|NCT02110758|142867544|OTHER|||||||0.013|||||||Regression, Logistic|||To estimate exposure to the intervention on the Exchanging Information composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.013
71674884|NCT02110758|142867544|OTHER|||||||0.053|||||||Regression, Logistic|||To estimate exposure to the intervention on the Overall Rating of Treatment Team composite score, we used a difference-in-differences model with fixed effects for practices. The dependent variable was the composite score. The intervention effects were represented by the coefficient estimates for survey time period (pre or post) interacted with status (pilot or comparison).||||.053
71674885|NCT02110758|142867546|OTHER|||||||0.2|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Hospitalizations, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Hospitalizations. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.2
71674886|NCT02110758|142867546|OTHER|||||||0.62|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Emergency Department (ED) Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month ED Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.62
71799803|NCT03238911|143099247|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.0552|TWO_SIDED|95.0|-0.34|0.0|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.00|-0.34|0.0552
71799804|NCT03238911|143099247|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0023|TWO_SIDED|95.0|-0.6|-0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.13|-0.60|0.0023
71840905|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.447||||0.5259|TWO_SIDED|95.0|-1.246|0.352|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.352|-1.246|0.5259
71799805|NCT03238911|143099247|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.0008|TWO_SIDED|95.0|-0.8|-0.21|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.21|-0.80|0.0008
71799806|NCT03238911|143099247|SUPERIORITY||Mean Difference (Final Values)|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.49|-1.11|<0.0001
71799807|NCT03238911|143099247|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.01|-0.28|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.28|-1.01|0.0006
71799808|NCT03238911|143099247|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.94|-0.23|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.23|-0.94|0.0014
71799809|NCT03238911|143099248|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.7447|TWO_SIDED|95.0|-7.96|5.71|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||5.71|-7.96|0.7447
71799810|NCT03238911|143099248|SUPERIORITY||Mean Difference (Final Values)|-9.7||||0.0363|TWO_SIDED|95.0|-18.78|-0.63|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-0.63|-18.78|0.0363
71893497|NCT01073943|143308259|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|-2.7|||||ONE_SIDED|97.5|-8.8||||||||||-8.8|
71893498|NCT01073943|143308260|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71799811|NCT03238911|143099248|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.9242|TWO_SIDED|95.0|-10.56|9.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||9.59|-10.56|0.9242
71799812|NCT03238911|143099248|SUPERIORITY||Mean Difference (Final Values)|-11.17||||0.0602|TWO_SIDED|95.0|-22.84|0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.49|-22.84|0.0602
71893499|NCT01073943|143308261|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71893500|NCT01073943|143308262|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71799813|NCT03238911|143099248|SUPERIORITY||Mean Difference (Final Values)|-18.2||||0.0008|TWO_SIDED|95.0|-28.68|-7.73|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-7.73|-28.68|0.0008
71799814|NCT03238911|143099248|SUPERIORITY||Mean Difference (Final Values)|-19.79||||0.0031|TWO_SIDED|95.0|-32.75|-6.83|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-6.83|-32.75|0.0031
71799815|NCT03238911|143099249|SUPERIORITY||Mean Difference (Final Values)|0.037||||0.267|TWO_SIDED|95.0|-0.029|0.104|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.104|-0.029|0.2670
71799816|NCT03238911|143099249|SUPERIORITY||Mean Difference (Final Values)|0.085||||0.004|TWO_SIDED|95.0|0.028|0.142|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.142|0.028|0.0040
71799817|NCT03238911|143099249|SUPERIORITY||Mean Difference (Final Values)|0.064||||0.0472|TWO_SIDED|95.0|0.001|0.127|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.127|0.001|0.0472
71799818|NCT03238911|143099249|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.005|TWO_SIDED|95.0|0.031|0.171|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.171|0.031|0.0050
71799819|NCT03238911|143099249|SUPERIORITY||Mean Difference (Final Values)|0.101||||0.0061|TWO_SIDED|95.0|0.029|0.172|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.172|0.029|0.0061
71799820|NCT03238911|143099249|SUPERIORITY||Mean Difference (Final Values)|0.055||||0.1282|TWO_SIDED|95.0|-0.016|0.126|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.126|-0.016|0.1282
71799821|NCT03238911|143099251|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.4618|TWO_SIDED|95.0|-0.82|0.37|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.37|-0.82|0.4618
71799822|NCT03238911|143099251|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.366|TWO_SIDED|95.0|-0.54|0.2|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.20|-0.54|0.3660
71893501|NCT01073943|143308263|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71799823|NCT03238911|143099251|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.858|TWO_SIDED|95.0|-0.25|0.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.30|-0.25|0.8580
71893502|NCT01073943|143308264|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71893503|NCT01073943|143308265|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71893504|NCT01073943|143308267|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|4.5|||||ONE_SIDED|97.5|-0.1|||||||Mid colon comparison|||-0.1|
71799824|NCT03238911|143099251|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.0257|TWO_SIDED|95.0|0.05|0.74|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.74|0.05|0.0257
71799825|NCT03238911|143099251|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.0016|TWO_SIDED|95.0|0.19|0.77|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.77|0.19|0.0016
71799826|NCT03238911|143099251|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.0185|TWO_SIDED|95.0|0.07|0.76|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||0.76|0.07|0.0185
71799827|NCT03238911|143099252|SUPERIORITY||Mean Difference (Final Values)|-14.84||||0.1922|TWO_SIDED|95.0|-37.26|7.57|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||7.57|-37.26|0.1922
71799828|NCT03238911|143099252|SUPERIORITY||Mean Difference (Final Values)|-18.28||||0.5601|TWO_SIDED|95.0|-80.24|43.68|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||43.68|-80.24|0.5601
71799829|NCT03238911|143099252|SUPERIORITY||Mean Difference (Final Values)|-71.02||||0.0459|TWO_SIDED|95.0|-140.74|-1.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-1.30|-140.74|0.0459
71799830|NCT03238911|143099252|SUPERIORITY||Mean Difference (Final Values)|-207.33|||<|0.0001|TWO_SIDED|95.0|-268.82|-145.84|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-145.84|-268.82|<0.0001
71840906|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.085|||<|0.0001|TWO_SIDED|95.0|-1.736|-0.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.435|-1.736|<.0001
71840907|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.112|||<|0.0001|TWO_SIDED|95.0|-1.532|-0.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-0.693|-1.532|<.0001
71799831|NCT03238911|143099252|SUPERIORITY||Mean Difference (Final Values)|-78.6||||0.001|TWO_SIDED|95.0|-124.81|-32.39|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.39|-124.81|0.0010
71799832|NCT03238911|143099252|SUPERIORITY||Mean Difference (Final Values)|-58.79||||0.0002|TWO_SIDED|95.0|-88.75|-28.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-28.82|-88.75|0.0002
71799833|NCT03238911|143099253|SUPERIORITY||Mean Difference (Final Values)|40.82|||<|0.0001|TWO_SIDED|95.0|26.3|55.33|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||55.33|26.30|<0.0001
71799834|NCT03238911|143099253|SUPERIORITY||Mean Difference (Final Values)|6.61||||0.0089|TWO_SIDED|95.0|1.69|11.53|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||11.53|1.69|0.0089
71799835|NCT03238911|143099253|SUPERIORITY||Mean Difference (Final Values)|-43.48|||<|0.0001|TWO_SIDED|95.0|-54.92|-32.03|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||-32.03|-54.92|<0.0001
71799836|NCT03238911|143099253|SUPERIORITY||Mean Difference (Final Values)|-1.68||||0.373|TWO_SIDED|95.0|-5.41|2.04|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.04|-5.41|0.3730
71799837|NCT03238911|143099253|SUPERIORITY||Mean Difference (Final Values)|-1.63||||0.4778|TWO_SIDED|95.0|-6.15|2.9|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||2.90|-6.15|0.4778
71799838|NCT03238911|143099253|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.3575|TWO_SIDED|95.0|-5.44|1.98|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."||1.98|-5.44|0.3575
71799839|NCT03238911|143099254|SUPERIORITY||Risk Difference (RD)|-11.9||||0.005|TWO_SIDED|95.0|-20.1|-3.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.||-3.6|-20.1|0.0050
71799840|NCT06893809|143099268|SUPERIORITY||Median Difference (Net)|10.0|STANDARD_DEVIATION|5.0||0.05|TWO_SIDED|95.0|10.0|20.0|||Kruskal-Wallis|||Sixty male patients scheduled for TURP surgery were divided into three equal groups. The results were evaluated at a 95% confidence interval, with significance set at p \< 0.05. This was achieved using SPSS 15.0. Between-group comparisons were performed using One-way ANOVA, Kruskal-Wallis, Wilcoxon Signed Ranks, and Friedman tests. Within-group comparisons used Wilcoxon Signed Ranks tests, and Friedman tests were used for differences over time.||20|10|0.05
71840908|NCT04800211|143191000|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.054||||0.8248|TWO_SIDED|95.0|-0.535|0.427|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||0.427|-0.535|0.8248
71840909|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.821||||0.0002|TWO_SIDED|95.0|1.369|4.273|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||4.273|1.369|0.0002
71674887|NCT02110758|142867546|OTHER|||||||0.68|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Primary Care Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Primary Care Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.68
71674888|NCT02110758|142867546|OTHER|||||||0.03|||||||Regression, Logistic|||To estimate exposure to the intervention on Per Member Per Month Specialist Visits, we used a difference-in-differences model with fixed effects for practices. The dependent variable was Per Member Per Month Specialist Visits. The intervention effects were represented by the coefficient estimates for utilization time period (baseline or follow-up) interacted with status (pilot or comparison).||||0.03
71674889|NCT02074358|142867557|SUPERIORITY_OR_OTHER||mixed effect model|425.3|||<|0.001|TWO_SIDED|95.0|219.8|630.7|||Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||630.7|219.8|<0.001
71799841|NCT06893809|143099268|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0|>|0.05|TWO_SIDED|95.0|0.0|0.0||No adjustment for multiple comparisons was applied. Non-parametric method used due to ordinal scale structure.|Kruskal-Wallis||Patient and surgeon satisfaction were compared across study arms.|The aim of this analysis is to compare the three groups in terms of patient and surgeon satisfaction using a superiority approach. The null hypothesis is that there is no difference in satisfaction scores between the groups. Statistical significance was set at p \< 0.05.||0|0|>0.05
71799842|NCT06893809|143099270|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.05|TWO_SIDED|95.0|0.5|1.6|||Kruskal-Wallis|Non-parametric test used due to ordinal scale and non-normal distribution.|Sensory block levels compared across study arms using numerical dermatomal codes.|||1.6|0.5|0.05
71893505|NCT01073943|143308267|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|3.2|||||ONE_SIDED|97.5|-1.5|||||||Recto-sigmoid colon comparison|||-1.5|
71893506|NCT01073943|143308267|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|0.9|||||ONE_SIDED|97.5|-5.7|||||||Overall comparison: ascending colon, mid colon and recto-sigmoid colon|||-5.7|
71893507|NCT03830281|143308286|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|Mean Difference (Final Values)|0.02||||0.565|TWO_SIDED|95.0|-0.06|0.11|||Mixed Models Analysis|||||0.11|-0.06|0.565
71674890|NCT02074358|142867557|SUPERIORITY_OR_OTHER||mixed effect model|90.6||||0.131|TWO_SIDED|95.0|-31.3|212.4||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for any secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||212.4|-31.3|0.131
71674891|NCT02074358|142867558|SUPERIORITY_OR_OTHER||mixed effect model|-0.21||||0.389|TWO_SIDED|95.0|-0.73|0.3||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for other secondary endpoints since a non-significant treatment difference was observed for this first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|TGA Lag Time. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.30|-0.73|0.389
71799843|NCT06893809|143099272|SUPERIORITY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|95.0|0.07|0.93|||Kruskal-Wallis||Dermatomal regression levels were compared across groups at 60 minutes.|||0.93|0.07|<0.05
71799844|NCT01532687|143099275|SUPERIORITY|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.017|||||||Gehan-Wilcoxon|||Statistical results are for the full randomized population (n = 54). The study was originally designed with overall one-sided alpha of 5%, where a total of 73 patients (36 in the gemcitabine + placebo arm, and 37 in the gemcitabine + pazopanib arm) were required to achieve 80% power to detect a 2.5 month increase in median PFS (a hazard ratio of 0.55) between the two treatment arms. Study was closed early by the sponsor due to slow accrual and funds and thus was under powered.||||0.017
71799845|NCT01532687|143099275|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.195|||||||Gehan-Wilcoxon|||Comparison between the two arms for the liposarcoma subgroup||||0.195
71799846|NCT01532687|143099275|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.079|||||||Gehan-Wilcoxon|||Statistical results are for the 'other' sarcoma subgroup (n = 38)||||0.079
71674892|NCT02074358|142867558|SUPERIORITY_OR_OTHER||mixed effect model|-0.16||||0.142|TWO_SIDED|95.0|-0.38|0.06||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Lag Time. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.06|-0.38|0.142
71674893|NCT02074358|142867558|SUPERIORITY_OR_OTHER||mixed effect model|1.35||||0.2|TWO_SIDED|95.0|-0.81|3.52||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.52|-0.81|0.200
71674894|NCT02074358|142867558|SUPERIORITY_OR_OTHER||mixed effect model|4.62|||<|0.001|TWO_SIDED|95.0|2.8|6.44||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||6.44|2.80|<0.001
71674895|NCT02074358|142867559|SUPERIORITY_OR_OTHER||mixed effect model|21.1||||0.014|TWO_SIDED|95.0|4.9|37.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||37.2|4.9|0.014
71674896|NCT02074358|142867559|SUPERIORITY_OR_OTHER||mixed effect model|-6.4||||0.076|TWO_SIDED|95.0|-13.5|0.8||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.8|-13.5|0.076
71799847|NCT01532687|143099277|SUPERIORITY|Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups||||||0.5||||||Yate's continuity correction was applied because of the number of subjects and successes (n = 4)|One-sided Proportions Test|||Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)||||0.5
71799848|NCT01532687|143099277|SUPERIORITY|||||||0.3||||||Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.||||0.3
71840910|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.468|||<|0.0001|TWO_SIDED|95.0|1.85|5.086|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||5.086|1.850|<.0001
71674897|NCT02074358|142867560|SUPERIORITY_OR_OTHER||mixed effect model|0.0||||0.996|TWO_SIDED|95.0|-5.6|5.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||5.6|-5.6|0.996
71893508|NCT03830281|143308287|SUPERIORITY||LS Mean Difference|-24.1|||<|0.001|TWO_SIDED|95.0|-36.0|-12.2|||ANCOVA|||||-12.2|-36.0|<0.001
71674898|NCT02074358|142867560|SUPERIORITY_OR_OTHER||mixed effect model|-6.5|||<|0.001|TWO_SIDED|95.0|-9.5|-3.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-3.6|-9.5|<0.001
71674899|NCT02074358|142867561|SUPERIORITY_OR_OTHER||mixed effect model|-1.64|||<|0.001|TWO_SIDED|95.0|-2.16|-1.12||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model that included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.12|-2.16|<0.001
71840911|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|2.245||||0.0022|TWO_SIDED|95.0|0.812|3.679|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||3.679|0.812|0.0022
71840912|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.329|||<|0.0001|TWO_SIDED|95.0|1.768|4.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.891|1.768|<.0001
71840913|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|3.399|||<|0.0001|TWO_SIDED|95.0|2.252|4.545|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||4.545|2.252|<.0001
71840914|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.25||||0.0761|TWO_SIDED|95.0|-0.132|2.633|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||2.633|-0.132|0.0761
71840915|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.778||||0.0211|TWO_SIDED|95.0|0.269|3.286|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||3.286|0.269|0.0211
71840916|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|1.57||||0.3841|TWO_SIDED|95.0|-0.951|4.092|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||4.092|-0.951|0.3841
71893509|NCT03830281|143308288|SUPERIORITY||LS Mean Difference|-27.8|||<|0.001|TWO_SIDED|95.0|-42.6|-13.0|||ANCOVA|||||-13.0|-42.6|< 0.001
71799849|NCT01532687|143099277|SUPERIORITY|||||||0.8||||||Yate's continuity correction was applied because of the small number of participants and successes (n = 2).|One-sided Proportion Test|||Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.||||0.8
71799850|NCT01532687|143099278|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.481|||||||Gehan-Wilcoxon|||Overall survival estimated among all randomized participants (n = 54)||||0.481
71799851|NCT01532687|143099278|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.353|||||||Gehan-Wilcoxon|||Overall survival compared between the two arms for the liposarcoma subgroup (n = 16)||||0.353
71799852|NCT01532687|143099278|OTHER|Log-log plots revealed crossing of the curves at late time points, indicating a possible interaction between treatment arms over time. We used the Gehan-Wilcoxon test, which weights early differences between groups, to test whether there is a difference between the treatment arms early in the study.||||||0.408|||||||Gehan-Wilcoxon|||Overall survival comparison between the two treatment arms for the other sarcoma group (n = 38)||||0.408
71799853|NCT03160703|143099279|SUPERIORITY||Mean Difference (Net)|-0.02||||0.2681|TWO_SIDED|95.0|-0.05|0.01||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.01|-0.05|0.2681
71799854|NCT03160703|143099279|SUPERIORITY||Mean Difference (Net)|-0.05||||0.0043|TWO_SIDED|95.0|-0.08|-0.02||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.02|-0.08|0.0043
71799855|NCT03160703|143099279|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.05||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.05|-0.12|<.0001
71799856|NCT03160703|143099279|SUPERIORITY||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.08||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||-0.08|-0.15|<.0001
71799857|NCT03160703|143099279|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.0779|TWO_SIDED|95.0|0.0|0.06||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.06|-0.00|0.0779
71840917|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.69||||0.3934|TWO_SIDED|95.0|-1.084|4.464|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.464|-1.084|0.3934
71799858|NCT03160703|143099279|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.0001|TWO_SIDED|95.0|0.03|0.1||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.10|0.03|0.0001
71799859|NCT00047463|143099303|SUPERIORITY_OR_OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the groups would be similar in tolerance. This was a pilot study so we did not do a power calculation.||||0.26
71893510|NCT03830281|143308289|SUPERIORITY||LS Mean Difference|0.7||||0.532|TWO_SIDED|95.0|-1.4|2.8|||Mixed Models Analysis|||Statistical analysis during daytime is reported.||2.8|-1.4|0.532
71799860|NCT04589559|143099313|OTHER|Paired-samples t-test|Mean change score|-1.5||||0.152|TWO_SIDED|95.0|-3.67|0.67|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in cardiac-related interoceptive fear.|||0.67|-3.67|0.152
71799861|NCT04589559|143099314|OTHER|Paired-samples t-test|Mean change score|-6.2||||0.031|TWO_SIDED|95.0|-11.71|-0.69|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in trait anxiety.|||-0.69|-11.71|0.031
71799862|NCT04589559|143099315|OTHER|Paired-samples t-test|Mean change score|-1.9||||0.323|TWO_SIDED|95.0|-6.01|2.21|||t-test, 2 sided|Paired-samples t-test|A negative value of the estimation parameter of mean change score indicates a reduction in negative affect.|||2.21|-6.01|0.323
71799863|NCT04589559|143099316|OTHER|Paired-samples t-test|Mean change in the measure|0.58||||0.112|TWO_SIDED|95.0|-0.16|1.33|||t-test, 2 sided|Paired-samples t-test|A positive value of the estimation parameter of mean change in the measure indicates an increase in heart rate variability.|||1.33|-0.16|0.112
71799864|NCT01448850|143099329|SUPERIORITY_OR_OTHER||Rate ratio|0.92||||0.645|TWO_SIDED|90.0|0.68|1.25||Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.|Poisson regression|||||1.25|0.68|0.645
71674900|NCT02074358|142867561|SUPERIORITY_OR_OTHER||mixed effect model|-1.47|||<|0.001|TWO_SIDED|95.0|-1.95|-0.99||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.99|-1.95|<0.001
71674901|NCT02074358|142867561|SUPERIORITY_OR_OTHER||mixed effect model|-2.59|||<|0.001|TWO_SIDED|95.0|-3.3|-1.89||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.89|-3.30|<0.001
71674902|NCT02074358|142867561|SUPERIORITY_OR_OTHER||mixed effect model|-1.89|||<|0.001|TWO_SIDED|95.0|-2.59|-1.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-1.20|-2.59|<0.001
71674903|NCT02074358|142867561|SUPERIORITY_OR_OTHER||mixed effect model|8.47|||<|0.001|TWO_SIDED|95.0|6.29|10.66||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|aPTT. The ETP change from pre-PCC baseline was analyzed using a mixed effect model and included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||10.66|6.29|<0.001
71674904|NCT02074358|142867561|SUPERIORITY_OR_OTHER||mixed effect model|2.3|||<|0.001|TWO_SIDED|95.0|1.28|3.32||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|aPTT. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||3.32|1.28|<0.001
71674905|NCT02074358|142867562|SUPERIORITY_OR_OTHER||mixed effect model|-0.198|||<|0.001|TWO_SIDED|95.0|-0.266|-0.13||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.130|-0.266|<0.001
71799865|NCT02214147|143099350|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|1.12|1.8|||||Least Squares Geometric Means Ratio= Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||1.80|1.12|
71799866|NCT02214147|143099351|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|3.21|||||TWO_SIDED|90.0|2.33|4.43|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||4.43|2.33|
71840918|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.995||||0.7782|TWO_SIDED|95.0|-1.505|3.494|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||3.494|-1.505|0.7782
71893511|NCT03830281|143308289|SUPERIORITY||LS Mean Difference|0.4||||0.738|TWO_SIDED|95.0|-1.8|2.5|||Mixed Models Analysis|||Statistical analysis during 24-hour period is reported.||2.5|-1.8|0.738
71893512|NCT02201940|143308308|SUPERIORITY_OR_OTHER||||||<|0.001||||||Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|Binomial test|||||||< 0.001
71893513|NCT03192904|143308314|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71674906|NCT02074358|142867562|SUPERIORITY_OR_OTHER||mixed effect model|-0.17|||<|0.001|TWO_SIDED|95.0|-0.229|-0.111||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.111|-0.229|<0.001
71674907|NCT02074358|142867562|SUPERIORITY_OR_OTHER||mixed effect model|-0.239|||<|0.001|TWO_SIDED|95.0|-0.305|-0.173||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.173|-0.305|<0.001
71799867|NCT02214147|143099352|OTHER|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|2.54|||||TWO_SIDED|90.0|1.84|3.53|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function|||3.53|1.84|
71799868|NCT02664038|143099368|SUPERIORITY||Mean Difference (Final Values)|-2.82|STANDARD_ERROR_OF_MEAN|2.68|<|0.05|TWO_SIDED|0.05|-8.23|2.588|||ANCOVA|covaried for days of heavy drinking over the 30 days prior to randomization.||||2.588|-8.23|<.05
71799869|NCT02664038|143099369|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.66|<|0.05|TWO_SIDED|0.05|-3.26|3.61|||ANCOVA|Days of heavy drinking 30 days prior to randomization||||3.61|-3.26|<.05
71799870|NCT02664038|143099370|SUPERIORITY||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|1.49||0.77|TWO_SIDED|0.05|1.45|4.43|||Mixed Models Analysis|Repeated measure with Baseline, 13 weeks and 26 weeks||||4.43|1.45|.77
71799871|NCT02664038|143099371|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|1.53|<|0.05|TWO_SIDED|95.0|-1.61|4.5|||Mixed Models Analysis|||||4.50|-1.61|<.05
71799872|NCT02664038|143099372|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.43||0.05|TWO_SIDED|0.05|0.19|1.11|||t-test, 2 sided|||||1.11|.19|.05
71799873|NCT05421078|143099373|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
71799874|NCT05421078|143099373|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
71799875|NCT05421078|143099373|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
71799876|NCT05421078|143099374|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||p value is calculated||-15.14|-36.53|<.0001
71799877|NCT05421078|143099374|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
71799878|NCT05421078|143099374|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
71799879|NCT05421078|143099375|SUPERIORITY||Least Squares (LS) Means|-25.84|STANDARD_ERROR_OF_MEAN|5.387|<|0.0001|TWO_SIDED|95.0|-36.53|-15.14||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.14|-36.53|<.0001
71799880|NCT05421078|143099375|SUPERIORITY||Least Squares (LS) Means|-33.34|STANDARD_ERROR_OF_MEAN|5.378|<|0.0001|TWO_SIDED|95.0|-44.01|-22.66||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.66|-44.01|<.0001
71799881|NCT05421078|143099375|SUPERIORITY||Least Squares (LS) Means|-36.12|STANDARD_ERROR_OF_MEAN|5.323|<|0.0001|TWO_SIDED|95.0|-46.68|-25.55||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-25.55|-46.68|<.0001
71799882|NCT05421078|143099376|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
71799883|NCT05421078|143099376|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
71799884|NCT05421078|143099376|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
71799885|NCT05421078|143099377|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
71799886|NCT05421078|143099377|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
71799887|NCT05421078|143099377|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
71674908|NCT02074358|142867562|SUPERIORITY_OR_OTHER||mixed effect model|-0.176|||<|0.001|TWO_SIDED|95.0|-0.242|-0.11||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||-0.110|-0.242|<0.001
71799888|NCT05421078|143099378|SUPERIORITY||Least Squares (LS) Means|-27.2|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001|TWO_SIDED|95.0|-38.37|-16.04||p value is calculated|ANCOVA|||||-16.04|-38.37|<.0001
71799889|NCT05421078|143099378|SUPERIORITY||Least Squares (LS) Means|-31.23|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|-42.36|-20.1||p value is calculated|ANCOVA|||||-20.10|-42.36|<.0001
71799890|NCT05421078|143099378|SUPERIORITY||Least Squares (LS) Means|-36.81|STANDARD_ERROR_OF_MEAN|5.55|<|0.0001|TWO_SIDED|95.0|-47.83|-25.8||p value is calculated|ANCOVA|||||-25.80|-47.83|<.0001
71799891|NCT05421078|143099379|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
71799892|NCT05421078|143099379|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
71799893|NCT05421078|143099379|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
71799894|NCT05421078|143099380|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
71799895|NCT05421078|143099380|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
71799896|NCT05421078|143099380|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
71840919|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.552||||0.4576|TWO_SIDED|95.0|-1.171|4.274|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||4.274|-1.171|0.4576
71896314|NCT03114969|143314790|SUPERIORITY||Odds Ratio (OR)|3.896|||<|0.001|TWO_SIDED|95.0|2.133|7.118||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||7.118|2.133|<0.001
71799897|NCT05421078|143099381|SUPERIORITY||Least Squares (LS) Means|-19.0|STANDARD_ERROR_OF_MEAN|3.439|<|0.0001|TWO_SIDED|95.0|-25.83|-12.18||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-12.18|-25.83|<.0001
71799898|NCT05421078|143099381|SUPERIORITY||Least Squares (LS) Means|-22.45|STANDARD_ERROR_OF_MEAN|3.441|<|0.0001|TWO_SIDED|95.0|-29.28|-15.62||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-15.62|-29.28|<.0001
71799899|NCT05421078|143099381|SUPERIORITY||Least Squares (LS) Means|-24.86|STANDARD_ERROR_OF_MEAN|3.406|<|0.0001|TWO_SIDED|95.0|-31.62|-18.1||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.10|-31.62|<.0001
71799900|NCT05421078|143099382|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|||||-14.31|-33.56|<.0001
71799901|NCT05421078|143099382|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
71799902|NCT05421078|143099382|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
71799903|NCT05421078|143099383|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
71799904|NCT05421078|143099383|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
71799905|NCT05421078|143099383|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
71799906|NCT05421078|143099384|SUPERIORITY||Least Squares (LS) Means|-23.94|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|-33.56|-14.31||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.31|-33.56|<.0001
71674909|NCT02074358|142867563|SUPERIORITY_OR_OTHER||mixed effect models|-0.239||||0.204|TWO_SIDED|95.0|-0.625|0.146||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.146|-0.625|0.204
71799907|NCT05421078|143099384|SUPERIORITY||Least Squares (LS) Means|-28.39|STANDARD_ERROR_OF_MEAN|4.849|<|0.0001|TWO_SIDED|95.0|-38.01|-18.76||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-18.76|-38.01|<.0001
71799908|NCT05421078|143099384|SUPERIORITY||Least Squares (LS) Means|-28.55|STANDARD_ERROR_OF_MEAN|4.801|<|0.0001|TWO_SIDED|95.0|-38.08|-19.03||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.03|-38.08|<.0001
71799909|NCT05421078|143099385|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
71799910|NCT05421078|143099385|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
71799911|NCT05421078|143099385|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
71799912|NCT05421078|143099386|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
71799913|NCT05421078|143099386|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
71799914|NCT05421078|143099386|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
71799915|NCT05421078|143099387|SUPERIORITY||Least Squares (LS) Means|133.11|STANDARD_ERROR_OF_MEAN|10.205|<|0.0001|TWO_SIDED|95.0|112.85|153.36||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||153.36|112.85|<.0001
71840920|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.621||||0.0849|TWO_SIDED|95.0|-0.224|3.466|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.466|-0.224|0.0849
71799916|NCT05421078|143099387|SUPERIORITY||Least Squares (LS) Means|147.41|STANDARD_ERROR_OF_MEAN|10.195|<|0.0001|TWO_SIDED|95.0|127.17|167.64||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||167.64|127.17|<.0001
71799917|NCT05421078|143099387|SUPERIORITY||Least Squares (LS) Means|155.98|STANDARD_ERROR_OF_MEAN|10.1|<|0.0001|TWO_SIDED|95.0|135.93|176.02||p value is calculated|Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||176.02|135.93|<.0001
71799918|NCT02915029|143099429|SUPERIORITY|The primary hypothesis being tested was that the intervention will increase patient activation.|Mean Difference (Net)|8.7||||0.01|TWO_SIDED|95.0|1.9|15.5|||ANCOVA|Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.|This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.|Group 1(usual care) is the comparison group, group 2 is the intervention group.|Applied generalized estimating equations (GEE) to account for within family (household) clustering.|15.5|1.9|0.01
71799919|NCT00086580|143099456|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.467|0.795|||Regression, Cox|Cox proportional hazards model was stratified by Rai Stage Group||||0.795|0.467|<0.001
71799920|NCT00086580|143099457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.178|TWO_SIDED|95.0|-0.03|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of Overall Response.||0.15|-0.03|0.178
71799921|NCT00086580|143099457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.018|TWO_SIDED|95.0|0.02|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of complete response (CR).||0.15|0.02|0.018
71799922|NCT00086580|143099458|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.648||||0.042|TWO_SIDED|95.0|0.449|0.937||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group||||0.937|0.449|0.042
71799923|NCT00086580|143099459|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.562|||<|0.001|TWO_SIDED|95.0|0.42|0.752|||Regression, Cox|Cox regression model stratified by Rai Stage Group.||||0.752|0.420|<0.001
71799924|NCT00086580|143099461|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.718||||0.021|TWO_SIDED|95.0|0.543|0.951|||Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group.||||0.951|0.543|0.021
71799925|NCT00086580|143099469|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.102|TWO_SIDED|95.0|0.531|1.059|||Regression, Cox|||||1.059|0.531|0.102
71799926|NCT00086580|143099470|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.443|||<|0.001|TWO_SIDED|95.0|0.292|0.671|||Regression, Cox|||||0.671|0.292|<0.001
71799927|NCT00086580|143099471|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.066||||0.819|TWO_SIDED|95.0|0.619|1.836|||Regression, Cox|Cox proportional hazards model||||1.836|0.619|0.819
71799928|NCT00086580|143099472|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.416|||<|0.001|TWO_SIDED|95.0|0.25|0.69|||Regression, Cox|Cox proportional hazards model||||0.690|0.250|<0.001
71799929|NCT00086580|143099475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.014|TWO_SIDED|95.0|0.01|0.08|||Cochran-Mantel-Haenszel|CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.||||0.08|0.01|0.014
71799930|NCT04452188|143099476|EQUIVALENCE|Prior studies suggest a 25-50% reduction in oxidative stress in normoxia relative to supra-physiologic oxygen. A 20% difference was considered clinically meaningful, and a sample size of 42 total participants was anticipated to achieve at least 80% power with a two-sided 5% significance level. However, an interim analysis recommended by the DSMB after enrollment of 29 patients revealed a significant difference in the primary outcome between the groups, and enrollment was thus stopped.|||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||Each participant's post-operative samples were normalized to their baseline sample and described as a fold-of-change from baseline.||||<0.01
71799931|NCT04452188|143099478|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the post-operative length of stay between the two groups.||||0.66
71799932|NCT04452188|143099479|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test was used to compare the days alive and out of ICU at 30 days since surgery between the two groups||||0.66
71799933|NCT04452188|143099480|OTHER|||||||1|||||||Fisher Exact|||||||1.00
71799934|NCT04452188|143099481|OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
71799935|NCT04452188|143099482|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
71799936|NCT04452188|143099483|OTHER||||||<|0.01||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.01
71799937|NCT04452188|143099484|OTHER||||||<|0.1||||||To provide a more conservative estimate of significance, the Hochberg sequential procedure was used for adjustment of multiple comparisons in the serum biomarker data including the primary outcome.|t-test, 2 sided|||||||<0.1
71799938|NCT02047110|143099486|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2652|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||26.6|-12.1|0.2652
71799939|NCT02047110|143099486|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4129|TWO_SIDED|90.0|-15.9|20.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||20.8|-15.9|0.4129
71893514|NCT01309737|143308329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.0001|TWO_SIDED|95.0|5.33|17.68||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||17.68|5.33|<0.0001
71893515|NCT01309737|143308329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.43|||<|0.0001|TWO_SIDED|95.0|8.99|30.59||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.59|8.99|<0.0001
71799940|NCT02047110|143099486|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4243|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.||17.0|-21.8|0.4243
71799941|NCT02047110|143099487|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.0229|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||-0.1|-0.7|0.0229
71799942|NCT02047110|143099487|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.3||||0.1038|TWO_SIDED|90.0|-0.6|0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||0.1|-0.6|0.1038
71799943|NCT02047110|143099487|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.5||||0.0101|TWO_SIDED|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||-0.1|-0.7|0.0101
71799944|NCT02047110|143099488|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.0||||0.0238|TWO_SIDED|90.0|-4.6|33.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||33.8|-4.6|0.0238
71799945|NCT02047110|143099488|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.1||||0.012|TWO_SIDED|90.0|-0.8|35.3||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||35.3|-0.8|0.0120
71799946|NCT02047110|143099488|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.0465|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.0465
71799947|NCT02047110|143099489|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|90.0|-19.4|19.4|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||19.4|-19.4|
71799948|NCT02047110|143099489|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1|||||TWO_SIDED|90.0|-18.3|18.3|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||18.3|-18.3|
71799949|NCT02047110|143099489|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|90.0|-12.1|26.6|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.||26.6|-12.1|
71799950|NCT02047110|143099490|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.0||||0.0092|TWO_SIDED|90.0|5.5|43.1||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||43.1|5.5|0.0092
71799951|NCT02047110|143099490|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.3||||0.1243|TWO_SIDED|90.0|-5.9|30.5||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||30.5|-5.9|0.1243
71799952|NCT02047110|143099490|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5||||0.1198|TWO_SIDED|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||31.4|-7.1|0.1198
71677322|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.178|||||TWO_SIDED|95.0|1.449|3.276||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.276|1.449|
71799953|NCT02047110|143099491|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.4||||0.1241|TWO_SIDED|90.0|-1.0|0.2||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."|||0.2|-1.0|0.1241
71799954|NCT02047110|143099491|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|0.3||||0.3033|TWO_SIDED|90.0|-0.5|1.0||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."|||1.0|-0.5|0.3033
71799955|NCT02047110|143099491|SUPERIORITY_OR_OTHER||Median estimate by Hodges-Lehmann method|-0.2||||0.3203|TWO_SIDED|90.0|-0.8|0.4||One sided p-value from Wilcoxon rank-sum test|Wilcoxon rank-sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."|||0.4|-0.8|0.3203
71799956|NCT02047110|143099492|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5||||0.2639|TWO_SIDED|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|||26.6|-12.1|0.2639
71799957|NCT02047110|143099492|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.1||||0.2691|TWO_SIDED|90.0|-10.9|25.7||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|||25.7|-10.9|0.2691
71799958|NCT02047110|143099492|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.5||||0.4174|TWO_SIDED|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|||17.0|-21.8|0.4174
71799959|NCT01959581|143099521|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Repeated measures ANOVA||||<.05
71799960|NCT00079274|143099524|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.15|TWO_SIDED|95.0|0.92|1.68|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.68|0.92|0.15
71799961|NCT00079274|143099525|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.25|TWO_SIDED|95.0|0.85|1.92|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.||||1.92|0.85|0.25
71799962|NCT00079274|143099526|SUPERIORITY||||||<|0.001|||||||Chi-squared|two-sided chi-squared test||||||<0.001
71799963|NCT00079274|143099527|SUPERIORITY||||||<|0.001|||||||Chi-squared|Two-sided chi-squared test||||||<0.001
71799964|NCT04542070|143099529|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.2|-0.5|
71799965|NCT04542070|143099529|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.9|||||TWO_SIDED|95.0|-0.5|2.2|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.2|-0.5|
71799966|NCT04542070|143099530|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Difference in percentage|0.7|||||TWO_SIDED|95.0|-0.6|2.0|||||Difference in percentage = percentage of Q2M - percentage of BIK|||2.0|-0.6|
71799967|NCT04542070|143099530|NON_INFERIORITY|Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.|Adjusted difference in percentage|0.7|||||TWO_SIDED|95.0|-0.7|2.0|||||Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.|||2.0|-0.7|
71799968|NCT00550836|143099562|SUPERIORITY|||||||0.36|||||||Log Rank|||It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.||||0.36
71799969|NCT00550836|143099563|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71799970|NCT00550836|143099564|SUPERIORITY|||||||0.419|||||||Log Rank|||||||0.419
71799971|NCT00550836|143099565|OTHER|||||||0.36|||||||Log Rank|||||||0.36
71799972|NCT02144675|143099570|OTHER||||||<|0.05|||||||Regression, Cox|||||||<.05
71799973|NCT01458171|143099605|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.45||||||||0.450||
71799974|NCT01458171|143099605|SUPERIORITY_OR_OTHER||Annualized Rate|0.0|||||ONE_SIDED|99.0||0.523||||||||0.523||
71799975|NCT01696032|143099612|SUPERIORITY|||||||0.0654|||||||Log Rank|||||||0.0654
71840921|NCT04800211|143191001|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.139||||0.9016|TWO_SIDED|95.0|-2.064|2.341|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||2.341|-2.064|0.9016
71674910|NCT02074358|142867563|SUPERIORITY_OR_OTHER||mixed effect models|-0.17||||0.114|TWO_SIDED|95.0|-0.389|0.048||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was \< 0.05, then the next comparison of interest was made until p\>0.05 at which point, comparisons ended.||0.048|-0.389|0.114
71674911|NCT02074358|142867573|SUPERIORITY_OR_OTHER||mixed effect model|1.039|||||TWO_SIDED|90.0|0.972|1.111|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A, and Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.111|0.972|
71799976|NCT01192152|143099624|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares means|1.045|||||TWO_SIDED|90.0|1.025|1.065|||||Ratio = Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.065|1.025|
71840922|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.587||||0.0004|TWO_SIDED|95.0|2.511|8.662|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.662|2.511|0.0004
71840923|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.556||||0.1141|TWO_SIDED|95.0|-0.62|5.732|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.732|-0.620|0.1141
71840924|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.536||||0.0007|TWO_SIDED|95.0|2.367|8.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.705|2.367|0.0007
71893516|NCT01309737|143308329|SUPERIORITY_OR_OTHER||Percent difference|13.08|STANDARD_ERROR_OF_MEAN|3.62||0.0003|TWO_SIDED|95.0|5.99|20.17|||Normal approximation|||||20.17|5.99|0.0003
71799977|NCT01192152|143099624|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|103.05||||||95.0||||||||Geometric least squares means for Treatment B||||
71840925|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|6.629|||<|0.0001|TWO_SIDED|95.0|3.68|9.577|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.577|3.680|<.0001
71840926|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.083||||0.0072|TWO_SIDED|95.0|1.118|7.047|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.047|1.118|0.0072
71840927|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.688||||0.0023|TWO_SIDED|95.0|1.691|7.686|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.686|1.691|0.0023
71840928|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.112|||<|0.0001|TWO_SIDED|95.0|2.874|7.35|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.350|2.874|<.0001
71893517|NCT01309737|143308330|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-45.73|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-52.98|-38.49||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-38.49|-52.98|<0.0001
71893518|NCT01309737|143308330|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.1|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|-65.33|-50.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-50.86|-65.33|<0.0001
71799978|NCT01192152|143099624|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|98.61||||||95.0||||||||Geometric least squares means for Treatment A||||
71799979|NCT01192152|143099625|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.035|||||TWO_SIDED|90.0|1.009|1.062|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.062|1.009|
71799980|NCT01192152|143099625|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|101.16||||||95.0||||||||Geometric least squares means for Treatment B||||
71799981|NCT01192152|143099625|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|97.72||||||95.0||||||||Geometric least squares means for Treatment A||||
71840929|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.777||||0.603|TWO_SIDED|95.0|-2.165|3.72|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.720|-2.165|0.6030
71840930|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.003||||0.5053|TWO_SIDED|95.0|-1.96|3.967|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.967|-1.960|0.5053
71840931|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.674||||0.6607|TWO_SIDED|95.0|-2.347|3.694|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.694|-2.347|0.6607
71840932|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.809||||0.1309|TWO_SIDED|95.0|-0.827|10.446|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.446|-0.827|0.1309
71840933|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.553||||0.9776|TWO_SIDED|95.0|-4.212|7.318|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||7.318|-4.212|0.9776
71893519|NCT01309737|143308330|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-18.24|-6.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-6.48|-18.24|<0.0001
71896315|NCT03114969|143314790|SUPERIORITY||Odds Ratio (OR)|4.777|||<|0.001|TWO_SIDED|95.0|2.508|9.1||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator.|||9.100|2.508|<0.001
71896316|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|7.347||||0.176|TWO_SIDED|95.0|0.408|132.143||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||132.143|0.408|0.176
71799982|NCT01192152|143099627|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares mean|0.999|||||TWO_SIDED|90.0|0.948|1.053|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.||1.053|0.948|
71799983|NCT01192152|143099627|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.85||||||95.0||||||||Geometric least squares means for Treatment B||||
71799984|NCT01192152|143099627|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|24.88||||||95.0||||||||Geometric least squares means for Treatment A||||
71799985|NCT01192152|143099644|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.894|||||TWO_SIDED|90.0|0.833|0.959|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.959|0.833|
71799986|NCT01192152|143099644|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|8713.4||||||95.0||||||||Geometric least squares mean for Treatment B||||
71799987|NCT01192152|143099644|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|9746.3||||||95.0||||||||Geometric least squares mean for Treatment A||||
71799988|NCT01192152|143099645|SUPERIORITY_OR_OTHER||ratio of geometric least squares means|0.906|||||TWO_SIDED|90.0|0.848|0.968|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.968|0.848|
71799989|NCT01192152|143099645|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|8377.8||||||95.0||||||||Geometric least squares means for Treatment B||||
71799990|NCT01192152|143099645|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|9246.8||||||95.0||||||||Geometric least squares mean for Treatment A||||
71799991|NCT01192152|143099647|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.917|||||TWO_SIDED|90.0|0.859|0.98|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.||0.980|0.859|
71799992|NCT01192152|143099647|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1055.9||||||95.0||||||||Geometric least squares means for Treatment B||||
71799993|NCT01192152|143099647|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|1151.2||||||95.0||||||||Geometric least squares means for Treatment A||||
71799994|NCT00378703|143099719|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm B (bevacizumab and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk)||||0.89
71799995|NCT00378703|143099719|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm C (bevacizumab and sorafenib) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.54
71799996|NCT00378703|143099719|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Log Rank|||Progression-free survival was compared between Arm D (sorafenib and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).||||0.68
71799997|NCT00378703|143099722|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0076
71799998|NCT00378703|143099722|SUPERIORITY_OR_OTHER|||||||0.0085|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.0085
71799999|NCT00378703|143099722|SUPERIORITY_OR_OTHER|||||||0.3006|TWO_SIDED|||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.||||0.3006
71800000|NCT01009099|143099732|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||ANCOVA|Co-variates included in the analysis were time walked on the constant workrate test at baseline and adherence (sessions completed/expected).||The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.||||0.63
71800001|NCT02188485|143099733|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.72||0.278|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Thwarted belonging (INQ-TB) at 10 week follow-up||||.278
71800002|NCT02188485|143099733|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.591|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|Perceived burden (INQ-PB) at 10-week follow-up||||.591
71896317|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|9.3||||0.128|TWO_SIDED|95.0|0.526|164.465||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||164.465|0.526|0.128
71800003|NCT02188485|143099734|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.52||0.511|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.511
71800004|NCT02188485|143099735|SUPERIORITY||Mean Difference (Final Values)|-2.47|STANDARD_ERROR_OF_MEAN|0.85||0.014|TWO_SIDED||||||Mixed Models Analysis||This mean difference is not identical to the mean difference presented in the summary table because this mean difference was adjusted for random effects in the model.|||||.014
71800005|NCT01868633|143099737|SUPERIORITY_OR_OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71800006|NCT02457325|143099742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
71800007|NCT02457325|143099743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.457|||||||t-test, 2 sided|||||||0.457
71800008|NCT02457325|143099744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
71800009|NCT02457325|143099745|SUPERIORITY_OR_OTHER_LEGACY|||||||0.953|||||||t-test, 2 sided|||||||0.953
71800010|NCT02457325|143099746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||t-test, 2 sided|||||||0.693
71800011|NCT02457325|143099747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||t-test, 2 sided|||||||0.158
71800012|NCT02457325|143099748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.192|||||||t-test, 2 sided|||||||0.192
71800013|NCT02457325|143099749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512|||||||t-test, 2 sided|||||||0.512
71800014|NCT02457325|143099750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.115|||||||t-test, 2 sided|||||||0.115
71800015|NCT02457325|143099751|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||t-test, 2 sided|||||||0.730
71800016|NCT02457325|143099752|SUPERIORITY_OR_OTHER_LEGACY|||||||0.835|||||||t-test, 2 sided|||||||0.835
71800017|NCT01556204|143099784|SUPERIORITY_OR_OTHER|||||||0.71||||||This p-value is from a single comparison between two arms for operative time.|t-test, 2 sided|||Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.||||0.71
71800018|NCT01556204|143099785|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: Baseline|Mixed Models Analysis|||Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.||||0.53
71800019|NCT01556204|143099785|SUPERIORITY_OR_OTHER|||||||0.53||||||This applies to Row title: 6-weeks|Mixed Models Analysis|||Pain scores at 6 weeks comparison between robotic and laparoscopy.||||0.53
71800020|NCT01556204|143099785|SUPERIORITY_OR_OTHER|||||||0.48||||||This applies to Row title: 6-months|Mixed Models Analysis|||Pain scores at 6 months for robotic vs laparoscopy.||||0.48
71800021|NCT02517905|143099817|SUPERIORITY||LSMD|-2.7||||0.8661|TWO_SIDED|95.0|-33.5|28.2|||ANOVA|||||28.2|-33.5|0.8661
71800022|NCT02517905|143099818|SUPERIORITY||LSMD|-4.0||||0.578|TWO_SIDED|95.0|-18.2|10.2|||ANOVA|||||10.2|-18.2|0.5780
71800023|NCT02517905|143099819|SUPERIORITY||LSMD|5.9||||0.801|TWO_SIDED|95.0|-40.2|52.1|||ANOVA|||||52.1|-40.2|0.8010
71800024|NCT02742103|143099823|OTHER||Rate difference (CSL112 - placebo)|-0.124|||||TWO_SIDED|95.0|-0.296|-0.005|||Newcombe-Wilson|||||-0.005|-0.296|
71800025|NCT02742103|143099824|OTHER||Rate difference (CSL112 - placebo)|-0.103|||||TWO_SIDED|95.0|-0.277|0.025|||Newcombe-Wilson|||||0.025|-0.277|
71800026|NCT00991302|143099840|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|stratified by dosing complexity||"Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.~The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID."||||0.52
71800027|NCT01709318|143099848|NON_INFERIORITY|Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|8.3|||||TWO_SIDED|95.0|-4.3|26.5|||||95% CI adjusted for multiplicity (Dunnett)|||26.5|-4.3|
71800028|NCT01709318|143099848|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.5|||||TWO_SIDED|95.0|-5.7|24.8|||||95% CI adjusted for multiplicity (Dunnett)|||24.8|-5.7|
71800029|NCT01709318|143099848|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|12.3|||||TWO_SIDED|95.0|-1.7|33.1|||||95% CI adjusted for multiplicity (Dunnett)|||33.1|-1.7|
71800030|NCT01709318|143099848|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.6|||||TWO_SIDED|95.0|-5.7|25.4|||||95% CI adjusted for multiplicity (Dunnett)|||25.4|-5.7|
71800031|NCT01709318|143099848|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|9.3|||||TWO_SIDED|95.0|-3.5|27.4|||||95% CI adjusted for multiplicity (Dunnett)|||27.4|-3.5|
71800032|NCT01709318|143099848|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-10.7|15.9|||||95% CI adjusted for multiplicity (Dunnett)|||15.9|-10.7|
71800033|NCT01709318|143099849|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.2|||||TWO_SIDED|95.0|-3.6|16.4|||||95% CI adjusted for multiplicity (Dunnett)|||16.4|-3.6|
71893520|NCT01309737|143308331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.5|||<|0.0001||95.0|3.48|17.31||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||17.31|3.48|<0.0001
71893521|NCT01309737|143308331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.53|||<|0.0001|TWO_SIDED|95.0|8.08|46.22||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||46.22|8.08|<0.0001
71893522|NCT01309737|143308331|SUPERIORITY_OR_OTHER||Percent Difference|14.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|7.72|20.88|||Normal Approximation|||||20.88|7.72|<0.0001
71800034|NCT01709318|143099849|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
71800035|NCT01709318|143099849|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.0|||||TWO_SIDED|95.0|-3.8|17.5|||||95% CI adjusted for multiplicity (Dunnett)|||17.5|-3.8|
71800036|NCT01709318|143099849|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|4.7|||||TWO_SIDED|95.0|-2.5|18.9|||||95% CI adjusted for multiplicity (Dunnett)|||18.9|-2.5|
71800037|NCT01709318|143099849|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|1.4|||||TWO_SIDED|95.0|-5.0|13.4|||||95% CI adjusted for multiplicity (Dunnett)|||13.4|-5.0|
71800038|NCT01709318|143099849|NON_INFERIORITY|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen's method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||TWO_SIDED|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)|||11.0|-6.2|
71800039|NCT01709318|143099850|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.08||||0.096|||||||LDA|||||||0.096
71800040|NCT01709318|143099850|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.993|||||||LDA|||||||0.993
71800041|NCT01709318|143099850|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.08||||0.124|||||||LDA|||||||0.124
71800042|NCT01709318|143099850|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.05||||0.845|||||||LDA|||||||0.845
71800043|NCT01709318|143099850|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||0.976|||||||LDA|||||||0.976
71800044|NCT01709318|143099850|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.995|||||||LDA|||||||0.995
71800045|NCT01709318|143099851|OTHER|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.01||||1|||||||LDA|||||||1.000
71896318|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|20.454||||0.038|TWO_SIDED|95.0|1.19|351.613||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||351.613|1.190|0.038
71800046|NCT01709318|143099851|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.19||||0.996|||||||LDA|||||||0.996
71800047|NCT01709318|143099851|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.06||||1|||||||LDA|||||||1.000
71674912|NCT02074358|142867573|SUPERIORITY_OR_OTHER||mixed effect model|1.021|||||TWO_SIDED|90.0|0.938|1.112|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.112|0.938|
71674913|NCT02074358|142867575|SUPERIORITY_OR_OTHER||mixed effect model|1.019|||||TWO_SIDED|90.0|0.955|1.087|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A). No adjustment was made for multiplicity.||1.087|0.955|
71674914|NCT02074358|142867575|SUPERIORITY_OR_OTHER||mixed effect model|1.018|||||TWO_SIDED|90.0|0.94|1.102|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.||1.102|0.940|
71800048|NCT01709318|143099851|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||1|||||||LDA|||||||1.000
71800049|NCT01709318|143099851|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.09||||1|||||||LDA|||||||1.000
71800050|NCT01709318|143099851|OTHER|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.24||||0.998|||||||LDA|||||||0.998
71800051|NCT00600821|143099883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.093||||0.639|TWO_SIDED|95.0|0.679|1.761||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.761|0.679|0.639
71800052|NCT00600821|143099884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.117||||0.699|TWO_SIDED|95.0|0.739|1.689||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.||1.689|0.739|0.699
71800053|NCT00600821|143099885|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.676||||0.9422|TWO_SIDED|95.0|0.412|1.107|||Cochran-Mantel-Haenszel|||P-value was calculated using 1-sided Cochran-Mantel-Haenszel test stratified by gender and prior adjuvant therapy. Risk ratio in comparison to the Bevacizumab group was calculated assuming all other factors as constant.||1.107|0.412|0.9422
71800054|NCT00023673|143099914|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Lung V20||||0.62
71800055|NCT00023673|143099914|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Lung V20||||0.22
71800056|NCT00023673|143099915|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|2-sided significance level = 0.05||Lung toxicity (\<Grade 3 vs. \>= Grade 3): Mean Lung Dose||||0.30
71800057|NCT00023673|143099915|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Lung Dose||||0.17
71674915|NCT01164579|142867585|SUPERIORITY_OR_OTHER||Difference in least squares (LS) Mean|-0.63|STANDARD_ERROR_OF_MEAN|0.57||0.2696|TWO_SIDED|90.0|-1.58|0.31||2-sided p-value; alpha equals (=) 0.10|mixed model repeated measures analysis|||||0.31|-1.58|0.2696
71800058|NCT00023673|143099915|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (\<Grade 2 vs. \>= Grade 2): Mean Esophageal Dose||||0.08
71674916|NCT01164579|142867585|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.52|STANDARD_ERROR_OF_MEAN|0.57||0.3561|TWO_SIDED|90.0|-1.46|0.41||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||||0.41|-1.46|0.3561
71674917|NCT01164579|142867586|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.55|STANDARD_ERROR_OF_MEAN|0.59||0.0089|TWO_SIDED|90.0|-2.52|-0.58||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.58|-2.52|0.0089
71800059|NCT02652624|143099951|NON_INFERIORITY|A sample size of 470 participants (\~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in percentages|0.0|||||TWO_SIDED|95.001|-2.9|2.9|||||The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.9|-2.9|
71800060|NCT02652624|143099951|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71893523|NCT01309737|143308333|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.97|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-3.8|-2.14||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-2.14|-3.80|<0.0001
71893524|NCT01309737|143308333|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001|TWO_SIDED|95.0|-5.13|-3.47||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.47|-5.13|<0.0001
71893525|NCT01309737|143308333|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.35||0.0001|TWO_SIDED|95.0|-2.01|-0.65|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.65|-2.01|0.0001
71674918|NCT01164579|142867586|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.74|STANDARD_ERROR_OF_MEAN|0.59||0.0038|TWO_SIDED|90.0|-2.72|-0.76||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis|||||-0.76|-2.72|0.0038
71674919|NCT01164579|142867587|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.57||0.6576|TWO_SIDED|90.0|-1.19|0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.69|-1.19|0.6576
71800061|NCT02652624|143099952|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in percentages|0.4|||||TWO_SIDED|95.001|-3.7|4.5|||||The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||4.5|-3.7|
71800062|NCT02652624|143099952|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71800063|NCT02652624|143099953|OTHER||Difference in least square means|3.0||||0.84|TWO_SIDED|95.0|-27.0|34.0|||ANOVA||Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.|||34|-27|0.84
71800064|NCT01560624|143099960|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0275|TWO_SIDED|95.0|0.56|0.97|||Cox proportion-hazard model|||||0.97|0.56|0.0275
71800065|NCT01560624|143099960|SUPERIORITY|||||||0.0391|||||||Log Rank|||||||0.0391
71800066|NCT01560624|143099961|SUPERIORITY||Hodges Lehmann estimate location shift|7.0||||0.0913|TWO_SIDED|95.0|0.0|16.0|||ANCOVA|||||16.0|0|0.0913
71800067|NCT01560624|143099962|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71800068|NCT01560624|143099963|SUPERIORITY|||||||0.0028|||||||Fisher Exact|||||||0.0028
71800069|NCT01797536|143099967|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR= Mild Hepatic Insufficiency Geometric Mean (GM) divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
71800070|NCT01797536|143099967|SUPERIORITY_OR_OTHER||GMR|0.72|||||TWO_SIDED|90.0|0.4|1.31|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.31|0.40|
71800071|NCT01797536|143099967|SUPERIORITY_OR_OTHER||GMR|0.88|||||TWO_SIDED|90.0|0.48|1.61|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.61|0.48|
71800072|NCT01797536|143099968|SUPERIORITY_OR_OTHER||GMR|0.6|||||TWO_SIDED|90.0|0.34|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.34|
71800073|NCT01797536|143099968|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
71800074|NCT01797536|143099968|SUPERIORITY_OR_OTHER||GMR|0.63|||||TWO_SIDED|90.0|0.35|1.13|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.13|0.35|
71800075|NCT01797536|143099969|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.05|0.32|
71800076|NCT01797536|143099969|SUPERIORITY_OR_OTHER||GMR|0.64|||||TWO_SIDED|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.14|0.35|
71800077|NCT01797536|143099969|SUPERIORITY_OR_OTHER||GMR|0.58|||||TWO_SIDED|90.0|0.32|1.08|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.32|
71800078|NCT01797536|143099970|SUPERIORITY_OR_OTHER||GMR|0.61|||||TWO_SIDED|90.0|0.34|1.08|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.08|0.34|
71800079|NCT01797536|143099970|SUPERIORITY_OR_OTHER||GMR|0.69|||||TWO_SIDED|90.0|0.38|1.25|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.25|0.38|
71893526|NCT01309737|143308333|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.46|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-5.51|-3.42||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-3.42|-5.51|<0.0001
71893527|NCT01309737|143308333|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.53|<|0.0001|TWO_SIDED|95.0|-7.14|-5.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-5.05|-7.14|<0.0001
71800080|NCT01797536|143099970|SUPERIORITY_OR_OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.43|1.43|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values||1.43|0.43|
71800081|NCT03161314|143100024|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Baseline||||0.660
71800082|NCT03161314|143100024|SUPERIORITY|||||||0.734|||||||t-test, 2 sided|||2 weeks after the intervention||||0.734
71800083|NCT03161314|143100024|SUPERIORITY|||||||0.629|||||||t-test, 2 sided|||4 weeks after the intervention||||0.629
71800084|NCT03161314|143100024|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||1-month follow-up||||0.752
71800085|NCT03161314|143100024|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||2-month follow-up||||0.512
71800086|NCT03161314|143100024|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71800087|NCT03161314|143100024|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71800088|NCT03161314|143100025|SUPERIORITY|||||||0.128|||||||t-test, 2 sided|||Baseline||||0.128
71800089|NCT03161314|143100025|SUPERIORITY|||||||0.889|||||||t-test, 2 sided|||2 weeks after the intervention||||0.889
71800090|NCT03161314|143100025|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||4 weeks after the intervention||||0.793
71893528|NCT01309737|143308333|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|0.43||0.0002|TWO_SIDED|95.0|-2.48|-0.79|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||-0.79|-2.48|0.0002
71800091|NCT03161314|143100025|SUPERIORITY|||||||0.602|||||||t-test, 2 sided|||1-month follow-up||||0.602
71800092|NCT03161314|143100025|SUPERIORITY|||||||0.574|||||||t-test, 2 sided|||2-month follow-up||||0.574
71800093|NCT03161314|143100025|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71800094|NCT03161314|143100025|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71800095|NCT03161314|143100026|SUPERIORITY|||||||0.374|||||||t-test, 2 sided|||Baseline||||0.374
71800096|NCT03161314|143100026|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||2 weeks after the intervention||||0.674
71800097|NCT03161314|143100026|SUPERIORITY|||||||0.781|||||||t-test, 2 sided|||4 weeks after the intervention||||0.781
71800098|NCT03161314|143100026|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||1-month follow-up||||0.778
71800099|NCT03161314|143100026|SUPERIORITY|||||||0.727|||||||t-test, 2 sided|||2-month follow-up||||0.727
71800100|NCT03161314|143100026|SUPERIORITY|||||||0.014|||||||ANOVA|||Within group comparison||||0.014
71800101|NCT03161314|143100026|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
71800102|NCT03161314|143100027|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline||||0.390
71800103|NCT03161314|143100027|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||2 weeks after the intervention||||0.770
71800104|NCT03161314|143100027|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||4 weeks after the intervention||||0.603
71800105|NCT03161314|143100027|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||1-month follow-up||||0.922
71800106|NCT03161314|143100027|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||2-month follow-up||||0.560
71800107|NCT03161314|143100027|SUPERIORITY|||||||0.181|||||||ANOVA|||Within group comparison||||0.181
71800108|NCT03161314|143100027|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71800109|NCT03161314|143100028|SUPERIORITY|||||||0.334|||||||t-test, 2 sided|||Baseline||||0.334
71800110|NCT03161314|143100028|SUPERIORITY|||||||0.766|||||||t-test, 2 sided|||2 weeks after the intervention||||0.766
71800111|NCT03161314|143100028|SUPERIORITY|||||||0.598|||||||t-test, 2 sided|||4 weeks after the intervention||||0.598
71800112|NCT03161314|143100028|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||1-month follow-up||||0.682
71800113|NCT03161314|143100028|SUPERIORITY|||||||0.707|||||||t-test, 2 sided|||2-month follow-up||||0.707
71800114|NCT03161314|143100028|SUPERIORITY|||||||0.008|||||||ANOVA|||Within group comparison||||0.008
71800115|NCT03161314|143100028|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
71800116|NCT03161314|143100029|SUPERIORITY|||||||0.287|||||||t-test, 2 sided|||Baseline||||0.287
71800117|NCT03161314|143100029|SUPERIORITY|||||||0.861|||||||t-test, 2 sided|||2 weeks after the intervention||||0.861
71800118|NCT03161314|143100029|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||4 weeks after the intervention||||0.641
71800119|NCT03161314|143100029|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||1-month follow-up||||0.864
71800120|NCT03161314|143100029|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||2-month follow-up||||0.888
71800121|NCT03161314|143100029|SUPERIORITY|||||||0.262|||||||ANOVA|||Within group comparison||||0.262
71800122|NCT03161314|143100029|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71840934|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.862||||0.1422|TWO_SIDED|95.0|-0.939|10.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||10.663|-0.939|0.1422
71800123|NCT04304001|143100030|SUPERIORITY||||||<|0.05|||||||Chi-squared|||For each arm, the proportion of participants who receive colorectal cancer screening by 12 months was computed. The chi-square test was used to compare the two treatment arms for screening receipt. If the proportion of participants receiving colorectal cancer screening in the intervention arm is at least 15% higher than that in the control arm, the intervention was determined to be effective.||||<0.05
71800124|NCT04304001|143100031|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the knowledge scale to compare differences between the intervention and control arms. Since knowledge was a continuous variable,the values between study arms were compared using two-sample independent t-tests.||||<0.05
71800125|NCT04304001|143100032|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Bivariate analyses was conducted for the self-efficacy scale to compare differences between the intervention and control arms. Since self-efficacy was a continuous variable, the values between study arms were compared using two-sample independent t-tests.||||<0.05
71800126|NCT04456699|143100054|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.9774|TWO_SIDED|95.0|1.0|1.97|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.97|1.00|0.9774
71800127|NCT04456699|143100054|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.9993|TWO_SIDED|95.0|1.23|2.49|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||2.49|1.23|0.9993
71800128|NCT04456699|143100055|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1527|TWO_SIDED|95.0|0.54|1.21|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.21|0.54|0.1527
71800129|NCT04456699|143100055|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2491|TWO_SIDED|95.0|0.59|1.3|||Log Rank|One-sided p-value based on log-rank test stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior FOLFOX/CAPOX + Bev induction response, number of induction cycles and mutation status.|||1.30|0.59|0.2491
71800130|NCT04456699|143100056|SUPERIORITY||Difference in Percentage|-0.2||||0.5272|TWO_SIDED|95.0|-7.0|6.5|||Miettinen and Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||6.5|-7.0|0.5272
71800131|NCT04456699|143100056|SUPERIORITY||Difference in Percentage|-3.2||||0.902|TWO_SIDED|95.0|-9.7|2.3|||Miettinen & Nurminen|Based on stratified Miettinen \& Nurminen method. One-sided p-value for testing H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by prior FOLFOX/CAPOX + Bev induction response, cycles and mutation status.|||2.3|-9.7|0.9020
71800132|NCT02203591|143100066|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71800133|NCT02203591|143100066|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71800134|NCT02203591|143100066|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71800135|NCT02203591|143100066|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71800136|NCT02203591|143100066|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71800137|NCT02203591|143100066|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71800138|NCT02203591|143100066|OTHER|95% confidence interval generation|Mean value|81.1|||||TWO_SIDED|95.0|75.6|86.6||||||||86.6|75.6|
71800139|NCT02203591|143100066|OTHER|95% confidence interval generation|Mean value|81.7|||||TWO_SIDED|95.0|76.3|87.1||||||||87.1|76.3|
71800140|NCT02203591|143100066|OTHER|95% confidence interval generation|Mean value|83.2|||||TWO_SIDED|95.0|77.9|88.4||||||||88.4|77.9|
71800141|NCT02203591|143100066|OTHER|95% confidence interval generation|Mean value|38.9|||||TWO_SIDED|95.0|32.3|45.6||||||||45.6|32.3|
71800142|NCT02203591|143100066|OTHER|95% confidence interval generation|Mean value|46.9|||||TWO_SIDED|95.0|40.1|53.7||||||||53.7|40.1|
71800143|NCT02203591|143100066|OTHER|95% confidence interval generation|Mean value|53.0|||||TWO_SIDED|95.0|46.3|59.6||||||||59.6|46.3|
71800144|NCT02203591|143100067|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.57|-0.1|||||3M CHG/IPA C - Inguinal minus ChloraPrep - Inguinal|||-0.10|-0.57|
71800145|NCT02203591|143100067|NON_INFERIORITY|A non-inferior margin of 0.5 log10/cm\^2|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|97.5|-0.44|0.74|||||3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal|Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.||0.74|-0.44|
71800146|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.85|||TWO_SIDED|||||||||||||
71800147|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|2.86|STANDARD_DEVIATION|0.9|||TWO_SIDED|||||||||||||
71800148|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|2.83|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
71800149|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|1.0|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
71800150|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|3.46|STANDARD_DEVIATION|1.31|||TWO_SIDED|||||||||||||
71800151|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|3.49|STANDARD_DEVIATION|1.33|||TWO_SIDED|||||||||||||
71800152|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|3.69|STANDARD_DEVIATION|1.29|||TWO_SIDED|||||||||||||
71800153|NCT02203591|143100068|OTHER|Calculate mean value|Mean value|1.23|STANDARD_DEVIATION|0.73|||TWO_SIDED|||||||||||||
71800154|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|2.78|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
71800155|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.0|||TWO_SIDED|||||||||||||
71800156|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|2.75|STANDARD_DEVIATION|0.97|||TWO_SIDED|||||||||||||
71800157|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|0.76|STANDARD_DEVIATION|0.81|||TWO_SIDED|||||||||||||
71800158|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|2.84|STANDARD_DEVIATION|1.19|||TWO_SIDED|||||||||||||
71800159|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|2.99|STANDARD_DEVIATION|1.12|||TWO_SIDED|||||||||||||
71800160|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|3.17|STANDARD_DEVIATION|1.24|||TWO_SIDED|||||||||||||
71800161|NCT02203591|143100069|OTHER|Calculate mean value|Mean value|1.01|STANDARD_DEVIATION|0.67|||TWO_SIDED|||||||||||||
71800162|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|0.8|STANDARD_DEVIATION|0.84|||TWO_SIDED|||||||||||||
71800163|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|0.74|STANDARD_DEVIATION|0.79|||TWO_SIDED|||||||||||||
71893529|NCT01309737|143308334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.0001|TWO_SIDED|95.0|1.89|8.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||8.95|1.89|<.0001
71800164|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|0.81|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
71800165|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|2.65|STANDARD_DEVIATION|0.89|||TWO_SIDED|||||||||||||
71800166|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|2.76|STANDARD_DEVIATION|1.2|||TWO_SIDED|||||||||||||
71800167|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|2.73|STANDARD_DEVIATION|1.22|||TWO_SIDED|||||||||||||
71800168|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|2.58|STANDARD_DEVIATION|1.18|||TWO_SIDED|||||||||||||
71800169|NCT02203591|143100070|OTHER|Calculate mean value|Mean value|4.85|STANDARD_DEVIATION|0.75|||TWO_SIDED|||||||||||||
71800170|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|0.85|STANDARD_DEVIATION|0.95|||TWO_SIDED|||||||||||||
71800171|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|0.87|STANDARD_DEVIATION|0.98|||TWO_SIDED|||||||||||||
71800172|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|0.89|STANDARD_DEVIATION|0.94|||TWO_SIDED|||||||||||||
71800173|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|2.88|STANDARD_DEVIATION|0.7|||TWO_SIDED|||||||||||||
71800174|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|3.39|STANDARD_DEVIATION|1.1|||TWO_SIDED|||||||||||||
71800175|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|3.21|STANDARD_DEVIATION|1.04|||TWO_SIDED|||||||||||||
71800176|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|3.08|STANDARD_DEVIATION|1.14|||TWO_SIDED|||||||||||||
71800177|NCT02203591|143100071|OTHER|Calculate mean value|Mean value|5.08|STANDARD_DEVIATION|0.68|||TWO_SIDED|||||||||||||
71800178|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|3.63|STANDARD_DEVIATION|0.46|||TWO_SIDED|||||||||||||
71800179|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|3.61|STANDARD_DEVIATION|0.48|||TWO_SIDED|||||||||||||
71800180|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.49|||TWO_SIDED|||||||||||||
71800181|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|3.64|STANDARD_DEVIATION|0.53|||TWO_SIDED|||||||||||||
71800182|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|6.23|STANDARD_DEVIATION|0.6|||TWO_SIDED|||||||||||||
71800183|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|6.22|STANDARD_DEVIATION|0.56|||TWO_SIDED|||||||||||||
71800184|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|6.27|STANDARD_DEVIATION|0.62|||TWO_SIDED|||||||||||||
71800185|NCT02203591|143100072|OTHER|Calculate mean value|Mean value|6.09|STANDARD_DEVIATION|0.63|||TWO_SIDED|||||||||||||
71800186|NCT04099524|143100076|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|-0.18|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
71800187|NCT04099524|143100076|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||||||<0.05
71800188|NCT04099524|143100077|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|chi-square|3.14|||<|0.05|TWO_SIDED||||||Chi-squared|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
71800189|NCT04099524|143100078|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.2|||<|0.05|TWO_SIDED|||||multiple correction adjusted p\<0.05|Mixed Models Analysis|||p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||<0.05
71800190|NCT04099524|143100079|SUPERIORITY|The analysis was based on evaluating whether active tDCS is superior than sham tDCS on outcomes.|Mean Difference (Final Values)|0.84|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||||<0.05
71674920|NCT01164579|142867587|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.55||0.7565|TWO_SIDED|90.0|-1.09|0.74||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.74|-1.09|0.7565
71674921|NCT01164579|142867587|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.94|STANDARD_ERROR_OF_MEAN|0.58||0.1038|TWO_SIDED|90.0|-1.89|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.01|-1.89|0.1038
71674922|NCT01164579|142867587|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.59||0.0868|TWO_SIDED|90.0|-1.98|-0.04||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.04|-1.98|0.0868
71674923|NCT01164579|142867587|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6|STANDARD_ERROR_OF_MEAN|0.62||0.0103|TWO_SIDED|90.0|-2.62|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-2.62|0.0103
71800191|NCT00298038|143100080|SUPERIORITY|Analysis based on the overall comparison of time to the first breakthrough overt HE episode between rifaximin and placebo groups adjusting for analysis region, using the Cox proportional hazards model (Score test, \[that is, Log rank test stratified by analysis region\]) with a 2-sided test at a significance level of 0.05 under the proportional hazards assumption.|Hazard Ratio (HR)|0.421|||<|0.0001|TWO_SIDED|95.0|0.276|0.641|||Cox proportional hazards model|||||0.641|0.276|<0.0001
71800192|NCT04733157|143100089|OTHER||Risk Ratio (RR)|0.87|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|0.69|1.09||Threshold for statistical significance was 0.05|Chi-squared|||||1.09|0.69|0.33
71800193|NCT02573324|143100126|SUPERIORITY||Cox Proportional Hazard|1.02||||0.633|TWO_SIDED|95.0|0.82|1.26||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|Terms abbreviated below: O6-methylguaninemethlytransferese (MGMT); Recursive Partitioning Analysis (RPA); EGFRde2-7 (EGFRvIII)||1.26|0.82|0.633
71800194|NCT02573324|143100126|SUPERIORITY|||||||0.704||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.704
71800195|NCT02573324|143100127|SUPERIORITY||Cox Proportional Hazard|0.97||||0.504|TWO_SIDED|95.0|0.76|1.24||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.24|0.76|0.504
71800196|NCT02573324|143100127|SUPERIORITY|||||||0.599||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.599
71800197|NCT02573324|143100128|SUPERIORITY||Cox Proportional Hazard|1.17||||0.773|TWO_SIDED|95.0|0.76|1.8||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world, and EGFRvIII mutation status as covariates.|||1.80|0.76|0.773
71800198|NCT02573324|143100128|SUPERIORITY|||||||0.74||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.740
71800199|NCT02573324|143100129|SUPERIORITY||Cox Proportional Hazard|0.95||||0.381|TWO_SIDED|95.0|0.71|1.27||Weighted log-rank P-value: Stratified Fleming-Harrington (ρ = 0, γ = 0.2) test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.27|0.71|0.381
71893530|NCT01309737|143308334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.25|||<|0.0001|TWO_SIDED|95.0|4.08|19.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||19.95|4.08|<.0001
71893531|NCT01309737|143308334|SUPERIORITY_OR_OTHER||Percent difference|10.79|STANDARD_ERROR_OF_MEAN|3.02||0.0004|TWO_SIDED|95.0|4.87|16.71|||Normal Approximation|||||16.71|4.87|0.0004
71674924|NCT01164579|142867587|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.53|0.55||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.55|-1.53|0.4350
71674925|NCT01164579|142867588|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.58||0.489|TWO_SIDED|90.0|-1.36|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.56|-1.36|0.4890
71674926|NCT01164579|142867588|SUPERIORITY_OR_OTHER||Difference in LS Means|0.08|STANDARD_ERROR_OF_MEAN|0.57||0.8817|TWO_SIDED|90.0|-0.85|1.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||1.02|-0.85|0.8817
71674927|NCT01164579|142867588|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.24|STANDARD_ERROR_OF_MEAN|0.59||0.0351|TWO_SIDED|90.0|-2.21|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.27|-2.21|0.0351
71800200|NCT02573324|143100129|SUPERIORITY|||||||0.409||||||Log-rank P-value (1-sided): Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank|||||||0.409
71800201|NCT02573324|143100130|SUPERIORITY||Cox Proportional Hazard|0.84||||0.029|TWO_SIDED|95.0|0.7|1.01||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.01|0.70|0.029
71674928|NCT01164579|142867588|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.32|STANDARD_ERROR_OF_MEAN|0.58||0.0231|TWO_SIDED|90.0|-2.28|-0.37||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.37|-2.28|0.0231
71800202|NCT02573324|143100131|SUPERIORITY||Cox Proportional Hazard|0.72||||0.002|TWO_SIDED|95.0|0.56|0.93||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||0.93|0.56|0.002
71800203|NCT02573324|143100132|SUPERIORITY||Cox Proportional Hazard|1.329||||0.994|TWO_SIDED|95.0|1.087|1.626||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.626|1.087|0.994
71800204|NCT02573324|143100133|SUPERIORITY||Cox Proportional Hazard|1.185||||0.938|TWO_SIDED|95.0|0.972|1.446||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.446|0.972|0.938
71800205|NCT02573324|143100134|SUPERIORITY||Cox Proportional Hazard|1.136||||0.814|TWO_SIDED|95.0|0.921|1.402||Stratified log-rank test was used. Stratified by randomization stratification factors namely: MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status.|Log Rank||Based on multivariate Cox proportional hazards model including treatment, MGMT methylation status, RPA class, region of the world and EGFRvIII mutation status as covariates.|||1.402|0.921|0.814
71800206|NCT02096835|143100165|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
71800207|NCT02096835|143100166|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
71800208|NCT02096835|143100167|SUPERIORITY_OR_OTHER|||||||0.503|TWO_SIDED||||||Chi-squared|||||||0.503
71800209|NCT02096835|143100168|SUPERIORITY_OR_OTHER|||||||0.571|TWO_SIDED||||||Chi-squared|||||||0.571
71800210|NCT03892889|143100170|OTHER||||||<|0.0001|TWO_SIDED|||||Paired t-test was used based on the prospective phase efficacy sample when applicable.|paired t-test|||||||<0.0001
71840935|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|5.851||||0.0334|TWO_SIDED|95.0|0.307|11.396|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||11.396|0.307|0.0334
71674929|NCT01164579|142867588|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1|STANDARD_ERROR_OF_MEAN|0.62||0.0008|TWO_SIDED|90.0|-3.13|-1.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.08|-3.13|0.0008
71674930|NCT01164579|142867588|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.29|STANDARD_ERROR_OF_MEAN|0.63||0.0003|TWO_SIDED|90.0|-3.32|-1.25||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-1.25|-3.32|0.0003
71674931|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.35||0.2689|TWO_SIDED|90.0|-0.96|0.19||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.19|-0.96|0.2689
71800211|NCT01777997|143100218|OTHER|||||||0.001|||||||Regression, repeated measures (GEE)|||Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.||||0.001
71800212|NCT02660359|143100227|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-8.97||||0.0001|TWO_SIDED|95.0|-13.5|-4.44|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-4.44|-13.5|0.0001
71800213|NCT02660359|143100227|SUPERIORITY|If both p-values for the 2 primary tests (the test of Dysport® 800 U vs. placebo and the test of Dysport® 600 U vs. placebo) were lower than 0.05, both were declared statistically significant. If 1 of the primary tests had a p-value greater than or equal to 0.05, then the other test was declared statistically significant if its p-value was lower than 0.025 and only the significant dose continued in the hierarchal testing strategy.|LS Mean Difference|-9.76|||<|0.0001|TWO_SIDED|95.0|-14.41|-5.12|||MMLM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[Botulinum toxin \[BTX\]-naïve or BTX-non-naïve\]) and study baseline value (weekly number of UI episodes) as fixed effect variables, and subject as a random effect.||-5.12|-14.41|<0.0001
71800214|NCT02660359|143100228|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|45.55||||0.0002|TWO_SIDED|95.0|6.09|340.69|||Generalised linear mixed model (GLMM)|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline- by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||340.69|6.09|0.0002
71674932|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|0.35||0.9935|TWO_SIDED|90.0|-0.58|0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||0.57|-0.58|0.9935
71800215|NCT02660359|143100228|SUPERIORITY|This secondary endpoint was included in the hierarchical analysis and was tested for both doses at the 0.05 level using a hierarchical methodology.|Odds Ratio (OR)|31.69||||0.0009|TWO_SIDED|95.0|4.17|240.58|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||240.58|4.17|0.0009
71800216|NCT02660359|143100229|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.55||||0.0007|TWO_SIDED|95.0|1.72|7.34||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 600 U versus Placebo.||7.34|1.72|0.0007
71800217|NCT02660359|143100229|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.94||||0.0037|TWO_SIDED|95.0|1.43|6.07||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥30% Improvement Level: Dysport® 800 U versus Placebo||6.07|1.43|0.0037
71800218|NCT02660359|143100229|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.03|7.79||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 600 U versus Placebo||7.79|2.03|<0.0001
71800219|NCT02660359|143100229|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by- visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|2.73||||0.0034|TWO_SIDED|95.0|1.4|5.33||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥50% Improvement level: Dysport® 800 U versus Placebo||5.33|1.40|0.0034
71800220|NCT02660359|143100229|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|7.38|||<|0.0001|TWO_SIDED|95.0|3.5|15.58||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 600 U versus Placebo||15.58|3.5|<0.0001
71800221|NCT02660359|143100229|SUPERIORITY|Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.|Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.48|11.24||This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|GLMM|||Treatment comparison at ≥75% Improvement level: Dysport® 800 U versus Placebo||11.24|2.48|<0.0001
71800222|NCT02660359|143100231|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|96.14|||<|0.0001|TWO_SIDED|95.0|53.1|139.19|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||139.19|53.10|<0.0001
71800223|NCT02660359|143100231|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|90.78|||<|0.0001|TWO_SIDED|95.0|47.07|134.48|||MMRM|||Treatment group, visit (Week 6), treatment-by-visit interaction, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX-naïve or BTX-non-naïve\]) and study baseline value (total volume per void) as fixed effect variables, and subject as a random effect.||134.48|47.07|<0.0001
71800224|NCT02660359|143100232|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|175.0|||<|0.0001|TWO_SIDED|95.0|122.9|227.0|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||227.0|122.90|<0.0001
71800225|NCT02660359|143100232|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|168.4|||<|0.0001|TWO_SIDED|95.0|113.6|223.1|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MCC as covariates.||223.1|113.6|<0.0001
71896319|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|18.776||||0.041|TWO_SIDED|95.0|1.131|311.669||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||311.669|1.131|0.041
71674933|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.35||0.1086|TWO_SIDED|90.0|-1.15|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.01|-1.15|0.1086
71674934|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8092|TWO_SIDED|90.0|-0.66|0.49||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.49|-0.66|0.8092
71674935|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.35||0.0463|TWO_SIDED|90.0|-1.29|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.12|-1.29|0.0463
71674936|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.0624|TWO_SIDED|90.0|-1.25|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.25|0.0624
71674937|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.37||0.0005|TWO_SIDED|90.0|-1.9|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.69|-1.90|0.0005
71674938|NCT01164579|142867589|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.26|STANDARD_ERROR_OF_MEAN|0.37||0.0008|TWO_SIDED|90.0|-1.87|-0.65||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.65|-1.87|0.0008
71674939|NCT01164579|142867590|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
71674940|NCT01164579|142867590|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
71800226|NCT02660359|143100233|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.9|||<|0.0001|TWO_SIDED|95.0|-41.5|-24.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-24.4|-41.5|<0.0001
71800227|NCT02660359|143100233|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|95.0|-41.5|-23.4|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of MDP as covariates.||-23.4|-41.5|<0.0001
71674941|NCT01164579|142867590|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
71800228|NCT02660359|143100234|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|152.8|||<|0.0001|TWO_SIDED|95.0|99.2|206.5|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||206.5|99.2|<0.0001
71800229|NCT02660359|143100234|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|LS Mean Difference|169.7|||<|0.0001|TWO_SIDED|95.0|111.7|227.6|||ANCOVA|||Treatment group, recorded stratification factors (aetiology of NDO \[SCI or MS\], prior intradetrusor \[BTX- naïve or BTX-non-naïve\]) and baseline value of Vol@1stIDC as covariates.||227.6|111.7|<0.0001
71800230|NCT02660359|143100235|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|31.1|||<|0.0001|TWO_SIDED|95.0|7.05|137.09|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by-visit interaction and study baseline weekly number of UI episodes as fixed effect.||137.09|7.05|<0.0001
71893532|NCT01309737|143308335|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.1786|TWO_SIDED|95.0|0.74|4.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||4.62|0.74|0.1786
71674942|NCT01164579|142867590|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27|||mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
71674943|NCT01164579|142867591|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.72||0.5019|TWO_SIDED|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.71|-1.68|0.5019
71674944|NCT01164579|142867591|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.73||0.1462|TWO_SIDED|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.14|-2.28|0.1462
71674945|NCT01164579|142867591|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.74||0.49|TWO_SIDED|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.72|-1.74|0.4900
71674946|NCT01164579|142867591|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.51|STANDARD_ERROR_OF_MEAN|0.75||0.0459|TWO_SIDED|90.0|-2.76|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.27|-2.76|0.0459
71674947|NCT01164579|142867592|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
71674948|NCT01164579|142867592|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
71674949|NCT01164579|142867592|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
71674950|NCT01164579|142867592|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
71674951|NCT01164579|142867593|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.5||0.8959|TWO_SIDED|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.76|-0.89|0.8959
71800231|NCT02660359|143100235|SUPERIORITY|This secondary endpoint was not included within the hierarchical testing procedure and was analysed for exploratory purposes only to compare each Dysport® dose to placebo at a 0.05 type one error rate.|Odds Ratio (OR)|28.08|||<|0.0001|TWO_SIDED|95.0|6.24|126.25|||GLMM|||Treatment group, recorded stratification factors, visit, treatment-by-visit interaction, study baseline-by- visit interaction and study baseline weekly number of UI episodes as fixed effect.||126.25|6.24|<0.0001
71800232|NCT04622254|143100243|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800233|NCT04622254|143100244|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800234|NCT04622254|143100245|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800235|NCT04622254|143100246|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800236|NCT04622254|143100247|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800237|NCT04622254|143100248|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800238|NCT04622254|143100249|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800239|NCT04622254|143100250|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71674952|NCT01164579|142867593|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.5||0.4193|TWO_SIDED|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.43|-1.25|0.4193
71800240|NCT04622254|143100251|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800241|NCT04622254|143100252|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71800242|NCT04622254|143100253|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800243|NCT04622254|143100254|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800244|NCT04622254|143100255|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800245|NCT04622254|143100255|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71800246|NCT04622254|143100256|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71800247|NCT04622254|143100256|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71800248|NCT03228680|143100262|NON_INFERIORITY|The pre-specified non-inferiority (NI) margin was -3.0 oocytes. The NI was evaluated based on the two-sided 95% CI from the ANOVA on 'number of oocytes retrieved' with treatment and AMH stratum as fixed factors.|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||If the lower bound of 95% CI was well above pre-specified NI limit of -3.0 oocytes, then NI of FE 999049 to FOLLISTIM with respect to number of oocytes retrieved in women undergoing controlled ovarian stimulation would be demonstrated|Mean number of oocytes retrieved.||-0.1|-2.3|
71800249|NCT03228680|143100263|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-7.5|10.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with at least one gestational sac 5-6 weeks after transfer.||10.6|-7.5|
71800250|NCT03228680|143100264|OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-9.5|9.6|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with positive beta-hCG.||9.6|-9.5|
71800251|NCT03228680|143100265|OTHER||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|-6.7|10.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of participants with vital pregnancy.||10.8|-6.7|
71800252|NCT03228680|143100266|OTHER||Risk Difference (RD)|1.9|||||TWO_SIDED|95.0|-8.9|12.8|||||The difference (FE 999049-FOLLISTIM) in rates was estimated and a two-sided 95% Cl was constructed using the Mantel-Haenszel method to combine results across AMH strata.|Percentage of implanted embryos 5-6 weeks after transfer.||12.8|-8.9|
71800253|NCT03228680|143100268|SUPERIORITY|||||||0.244||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with blastocyst transfer cancellation.||||0.244
71800254|NCT03228680|143100269|SUPERIORITY|||||||0.254||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \<4 oocytes retrieved (low response).||||0.254
71800255|NCT03228680|143100269|SUPERIORITY|||||||0.041||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 4-7 oocytes retrieved (moderate response).||||0.041
71800256|NCT03228680|143100269|SUPERIORITY|||||||0.705||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 8-14 oocytes retrieved (targeted response).||||0.705
71800257|NCT03228680|143100269|SUPERIORITY|||||||0.183||||||P-value was based on likelihood ratio test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with 15-19 oocytes retrieved (hyperresponse).||||0.183
71674953|NCT01164579|142867593|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.51||0.5764|TWO_SIDED|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.56|-1.13|0.5764
71800258|NCT03228680|143100269|SUPERIORITY|||||||0.03||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with \>= (more than equal to) 20 oocytes retrieved (severe hyperresponse).||||0.030
71800259|NCT03228680|143100270|SUPERIORITY|||||||0.893||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \< 15 pmol/L (\<4 oocytes retrieved)||||0.893
71800260|NCT03228680|143100270|SUPERIORITY|||||||0.002||||||P-value was based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=15 oocytes retrieved)||||0.002
71800261|NCT03228680|143100270|SUPERIORITY|||||||0.021||||||P-value based on likelihood ratio chi-square test.|Chi-squared|||Proportion of participants with extreme ovarian responses: AMH \>= 15 pmol/L (\>=20 oocytes retrieved)||||0.021
71800262|NCT03228680|143100272|SUPERIORITY|||||||0.017||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with early OHSS (any grade).||||0.017
71800263|NCT03228680|143100272|SUPERIORITY|||||||0.035||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe).||||0.035
71800264|NCT03228680|143100272|SUPERIORITY|||||||0.006||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (any grade) and/or preventive interventions.||||0.006
71674954|NCT01164579|142867593|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1101|TWO_SIDED|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.02|-1.69|0.1101
71800265|NCT03228680|143100272|SUPERIORITY|||||||0.009||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportion of participants with early OHSS (moderate/severe) and/or preventive interventions.||||0.009
71800266|NCT03228680|143100273|SUPERIORITY|||||||0.968||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (any grade).||||0.968
71800267|NCT03228680|143100273|SUPERIORITY|||||||0.582||||||P-value was based on likelihood ratio chi-square test.|Regression, Logistic|The model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors.||Proportions of participants with late OHSS (moderate/severe).||||0.582
71893533|NCT01309737|143308335|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.18||||0.0003|TWO_SIDED|95.0|1.77|10.25||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||10.25|1.77|0.0003
71674955|NCT01164579|142867594|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
71800268|NCT03228680|143100274|SUPERIORITY|||||||0.198||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles on stimulation Day 6 was analyzed.||||0.198
71800269|NCT03228680|143100275|SUPERIORITY|||||||0.036||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of follicles at end-of-stimulation was analyzed.||||0.036
71800270|NCT03228680|143100276|SUPERIORITY|||||||0.592||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.592
71800271|NCT03228680|143100277|SUPERIORITY|||||||0.286||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The average size of 3 largest follicles was analyzed.||||0.286
71800272|NCT03228680|143100278|SUPERIORITY|||||||0.395||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The fertilization rate (number of oocytes with 2 pronuclei divided by the number of oocytes retrieved) was analyzed.||||0.395
71893534|NCT01309737|143308335|SUPERIORITY_OR_OTHER||Percent Difference|6.72|STANDARD_ERROR_OF_MEAN|2.26||0.0029|TWO_SIDED|95.0|2.3|11.14|||Normal Approximation|||||11.14|2.30|0.0029
71800273|NCT03228680|143100279|SUPERIORITY|||||||0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of embryos on Day 3 was analyzed.||||0.001
71800274|NCT03228680|143100279|SUPERIORITY|||||||0.004||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality embryos on Day 3 was analyzed.||||0.004
71800275|NCT03228680|143100280|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of blastocysts on Day 5 was analyzed.||||<.001
71800276|NCT03228680|143100280|SUPERIORITY||||||<|0.001||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of good-quality blastocysts on Day 5 was analyzed.||||<0.001
71800277|NCT03228680|143100281|SUPERIORITY||Mean ratio|1.03||||0.228|TWO_SIDED|95.0|0.98|1.09||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH on stimulation Day 6.||1.09|0.98|0.228
71800278|NCT03228680|143100281|SUPERIORITY||Mean ratio|0.97||||0.777|TWO_SIDED|95.0|0.81|1.17||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH on stimulation Day 6.||1.17|0.81|0.777
71674956|NCT01164579|142867594|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
71674957|NCT01164579|142867594|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
71674958|NCT01164579|142867594|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
71674959|NCT01164579|142867595|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.35||0.2351|TWO_SIDED|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||0.16|-1.00|0.2351
71674960|NCT01164579|142867595|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0631|TWO_SIDED|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.08|-1.27|0.0631
71674961|NCT01164579|142867595|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.23|STANDARD_ERROR_OF_MEAN|0.36||0.5369|TWO_SIDED|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||0.38|-0.83|0.5369
71674962|NCT01164579|142867595|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.062|TWO_SIDED|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.08|-1.31|0.0620
71674963|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.12|STANDARD_ERROR_OF_MEAN|11.24||0.243|TWO_SIDED|90.0|-5.36|31.62|||Normal approximation to the binomial|||Month 1||31.62|-5.36|0.2430
71800279|NCT03228680|143100282|SUPERIORITY||Mean ratio|0.89|||<|0.001|TWO_SIDED|95.0|0.84|0.94||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of FSH at end-of-stimulation.||0.94|0.84|<0.001
71800280|NCT03228680|143100282|SUPERIORITY||Mean ratio|1.17||||0.057|TWO_SIDED|95.0|1.0|1.39||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of LH at end-of-stimulation.||1.39|1.00|0.057
71800281|NCT03228680|143100283|SUPERIORITY||Mean ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol on stimulation Day 6.||0.93|0.71|0.002
71800282|NCT03228680|143100284|SUPERIORITY||Mean ratio|0.85||||0.003|TWO_SIDED|95.0|0.76|0.95||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of estradiol at end-of-stimulation.||0.95|0.76|0.003
71674964|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 1||45.90|8.91|0.0147
71674965|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.03|STANDARD_ERROR_OF_MEAN|11.25||0.0127|TWO_SIDED|90.0|9.51|46.54|||Normal approximation to the binomial|||Month 2||46.54|9.51|0.0127
71674966|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.57|STANDARD_ERROR_OF_MEAN|11.45||0.0724|TWO_SIDED|90.0|1.73|39.41|||Normal approximation to the binomial|||Month 2||39.41|1.73|0.0724
71674967|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.49|STANDARD_ERROR_OF_MEAN|10.85||0.0086|TWO_SIDED|90.0|10.63|46.35|||Normal approximation to the binomial|||Month 3||46.35|10.63|0.0086
71674968|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.46|STANDARD_ERROR_OF_MEAN|11.55||0.2808|TWO_SIDED|90.0|-6.54|31.47|||Normal approximation to the binomial|||Month 3||31.47|-6.54|0.2808
71674969|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 9||46.55|9.81|0.0115
71674970|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.09|STANDARD_ERROR_OF_MEAN|11.56||0.1921|TWO_SIDED|90.0|-3.94|34.12|||Normal approximation to the binomial|||Month 9||34.12|-3.94|0.1921
71674971|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 12||46.55|9.81|0.0115
71674972|NCT01164579|142867596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.86|STANDARD_ERROR_OF_MEAN|11.5||0.1203|TWO_SIDED|90.0|-1.05|36.79|||Normal approximation to the binomial|||Month 12||36.79|-1.05|0.1203
71674973|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
71674974|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.15|STANDARD_ERROR_OF_MEAN|7.58||0.0078|TWO_SIDED|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1||32.62|7.68|0.0078
71800283|NCT03228680|143100285|SUPERIORITY||Mean ratio|1.02||||0.814|TWO_SIDED|95.0|0.89|1.16||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone on stimulation Day 6.||1.16|0.89|0.814
71800284|NCT03228680|143100286|SUPERIORITY||Mean ratio|0.78|||<|0.001|TWO_SIDED|95.0|0.68|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of progesterone levels at end-of-stimulation.||0.88|0.68|<0.001
71674975|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.49|STANDARD_ERROR_OF_MEAN|10.37||0.0044|TWO_SIDED|90.0|12.43|46.56|||Normal approximation to the binomial|||Month 2||46.56|12.43|0.0044
71674976|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43|||Normal approximation to the binomial|||Month 2||33.43|0.79|0.0845
71674977|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.24|STANDARD_ERROR_OF_MEAN|11.0||0.0275|TWO_SIDED|90.0|6.14|42.35|||Normal approximation to the binomial|||Month 3||42.35|6.14|0.0275
71674978|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.67|STANDARD_ERROR_OF_MEAN|10.91||0.0186|TWO_SIDED|90.0|7.71|43.63|||Normal approximation to the binomial|||Month 3||43.63|7.71|0.0186
71674979|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.52|STANDARD_ERROR_OF_MEAN|10.75||0.0009|TWO_SIDED|90.0|17.82|53.22|||Normal approximation to the binomial|||Month 6||53.22|17.82|0.0009
71674980|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.6|STANDARD_ERROR_OF_MEAN|10.72||0.0169|TWO_SIDED|90.0|7.95|43.24|||Normal approximation to the binomial|||Month 6||43.24|7.95|0.0169
71674981|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 9||45.90|8.91|0.0147
71800285|NCT03228680|143100287|SUPERIORITY||Mean ratio|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A on stimulation Day 6.||0.92|0.73|<0.001
71800286|NCT03228680|143100288|SUPERIORITY||Mean ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.72|0.88||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin A at end-of-stimulation.||0.88|0.72|<0.001
71800287|NCT03228680|143100289|SUPERIORITY||Mean ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B on stimulation Day 6.||0.93|0.75|<0.001
71893535|NCT01309737|143308336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.06|||<|0.0001|TWO_SIDED|95.0|5.02|16.45||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||16.45|5.02|<0.0001
71674982|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 9||33.11|-3.68|0.1882
71674983|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.41|STANDARD_ERROR_OF_MEAN|11.24||0.0147|TWO_SIDED|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 12||45.90|8.91|0.0147
71674984|NCT01164579|142867597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.71|STANDARD_ERROR_OF_MEAN|11.18||0.1882|TWO_SIDED|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 12||33.11|-3.68|0.1882
71674985|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57|STANDARD_ERROR_OF_MEAN|4.73||0.07|TWO_SIDED|90.0|0.78|16.35|||Normal approximation to the binomial|||Month 1||16.35|0.78|0.0700
71674986|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48|||Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
71674987|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.02|STANDARD_ERROR_OF_MEAN|8.68||0.0027|TWO_SIDED|90.0|11.73|40.3|||Normal approximation to the binomial|||Month 2||40.30|11.73|0.0027
71674988|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.81|STANDARD_ERROR_OF_MEAN|7.86||0.0324|TWO_SIDED|90.0|3.88|29.75|||Normal approximation to the binomial|||Month 2||29.75|3.88|0.0324
71674989|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|8.97||0.0969|TWO_SIDED|90.0|0.13|29.67|||Normal approximation to the binomial|||Month 3||29.67|0.13|0.0969
71674990|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.96|STANDARD_ERROR_OF_MEAN|9.04||0.0606|TWO_SIDED|90.0|2.09|31.84|||Normal approximation to the binomial|||Month 3||31.84|2.09|0.0606
71674991|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.66|STANDARD_ERROR_OF_MEAN|10.49||0.2276|TWO_SIDED|90.0|-4.6|29.93|||Normal approximation to the binomial|||Month 6||29.93|-4.60|0.2276
71674992|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.93|STANDARD_ERROR_OF_MEAN|10.23||0.3827|TWO_SIDED|90.0|-7.9|25.76|||Normal approximation to the binomial|||Month 6||25.76|-7.90|0.3827
71800288|NCT03228680|143100290|SUPERIORITY||Mean ratio|0.88||||0.027|TWO_SIDED|95.0|0.79|0.99||The P-value corresponds to the two-sided F-test of treatment effect.|ANCOVA|The ANCOVA model included treatment and AMH stratum (\<15 pmol/L and ≥15 pmol/L) as fixed factors and log-baseline as covariate.|Mean ratio is equal to FE 999049/FOLLISTIM.|Circulating levels of Inhibin B at end-of-stimulation.||0.99|0.79|0.027
71800289|NCT03228680|143100291|SUPERIORITY|||||||0.694||||||2-sided|van Elteren test|P-value was based on van Elteren test adjusted for AMH strata.||The number of stimulation days at end-of-stimulation.||||0.694
71800290|NCT01268644|143100301|SUPERIORITY|||||||0.14||||||P value comparing baseline to week 12|Mixed Models Analysis|||||||0.14
71674993|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|10.15||0.2177|TWO_SIDED|90.0|-4.18|29.2|||Normal approximation to the binomial|||Month 9||29.20|-4.18|0.2177
71674994|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12|||Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
71674995|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|9.8||0.8997|TWO_SIDED|90.0|-14.89|17.36|||Normal approximation to the binomial|||Month 12||17.36|-14.89|0.8997
71674996|NCT01164579|142867598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.71|STANDARD_ERROR_OF_MEAN|10.36||0.2587|TWO_SIDED|90.0|-5.34|28.76|||Normal approximation to the binomial|||Month 12||28.76|-5.34|0.2587
71893536|NCT01309737|143308336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.97|||<|0.0001||95.0|9.0|30.73||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.||30.73|9.00|<0.0001
71674997|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|90.0|-0.56|0.13||||||Baseline||0.13|-0.56|
71674998|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|90.0|-0.19|0.43||||||Baseline||0.43|-0.19|
71674999|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|||||TWO_SIDED|90.0|-1.38|-0.5||||||Month 1||-0.50|-1.38|
71675000|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||||TWO_SIDED|90.0|-1.01|-0.22||||||Month 1||-0.22|-1.01|
71675001|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.73|-0.7||||||Month 2||-0.70|-1.73|
71675002|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.2|-0.18||||||Month 2||-0.18|-1.20|
71675003|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81|||||TWO_SIDED|90.0|-1.33|-0.29||||||Month 3||-0.29|-1.33|
71675004|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|90.0|-0.94|0.12||||||Month 3||0.12|-0.94|
71675005|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.75|-0.61||||||Month 6||-0.61|-1.75|
71675006|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|90.0|-1.73|-0.63||||||Month 6||-0.63|-1.73|
71675007|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|||||TWO_SIDED|90.0|-1.81|-0.61||||||Month 9||-0.61|-1.81|
71675008|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||||TWO_SIDED|90.0|-1.33|-0.13||||||Month 9||-0.13|-1.33|
71675009|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|90.0|-1.69|-0.51||||||Month 12||-0.51|-1.69|
71800291|NCT01268644|143100302|SUPERIORITY|||||||0.01||||||P value comparing week 0 with week 12.|Mixed Models Analysis|||||||0.01
71800292|NCT01268644|143100303|SUPERIORITY|||||||0.009||||||P value comparing week 0 to week 12.|Mixed Models Analysis|||||||0.009
71800293|NCT01268644|143100304|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||||||0.75
71800294|NCT01416194|143100305|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
71800295|NCT01416194|143100305|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.91|TWO_SIDED|95.0|0.4|2.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.2|0.4|0.91
71800296|NCT01416194|143100306|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
71800297|NCT01416194|143100306|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.76|TWO_SIDED|95.0|0.5|2.4|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.4|0.5|0.76
71800298|NCT01416194|143100307|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.3|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.3|0.01
71675010|NCT01164579|142867599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|90.0|-1.51|-0.29||||||Month 12||-0.29|-1.51|
71675011|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.26||0.001|TWO_SIDED|90.0|-1.31|-0.45||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.45|-1.31|0.0010
71675012|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.26||0.0102|TWO_SIDED|90.0|-1.1|-0.24||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.24|-1.10|0.0102
71800299|NCT01416194|143100307|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.37|TWO_SIDED|95.0|0.4|1.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.4|0.37
71800300|NCT01416194|143100308|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.5|0.10
71800301|NCT01416194|143100308|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.19|TWO_SIDED|95.0|0.4|1.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.2|0.4|0.19
71800302|NCT01416194|143100309|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
71800303|NCT01416194|143100309|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.1|0.4|0.90
71800304|NCT01416194|143100310|SUPERIORITY||Hazard Ratio (HR)|1.9|||<|0.01|TWO_SIDED|95.0|1.4|2.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||2.5|1.4|<0.01
71800305|NCT01416194|143100310|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.7|1.3|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.7|0.74
71800306|NCT01416194|143100311|SUPERIORITY||Hazard Ratio (HR)|0.4|||<|0.01|TWO_SIDED|95.0|0.3|0.6|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.6|0.3|<0.01
71800307|NCT01416194|143100311|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.9|0.4|0.01
71800308|NCT01416194|143100312|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.1|<0.01
71800309|NCT01416194|143100312|SUPERIORITY||Hazard Ratio (HR)|0.4||||0.06|TWO_SIDED|95.0|0.2|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.2|0.06
71800310|NCT01416194|143100313|SUPERIORITY||Hazard Ratio (HR)|0.5|||<|0.01|TWO_SIDED|95.0|0.3|0.7|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.7|0.3|<0.01
71800311|NCT01416194|143100313|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.38|TWO_SIDED|95.0|0.5|1.4|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.4|0.5|0.38
71800312|NCT01416194|143100315|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.24|TWO_SIDED|95.0|0.9|1.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.5|0.9|0.24
71800313|NCT01416194|143100315|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.59|TWO_SIDED|95.0|0.8|1.6|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.6|0.8|0.59
71800314|NCT01416194|143100316|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.6|1.0|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.0|0.6|0.03
71800315|NCT01416194|143100316|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.6|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.1|0.6|0.19
71800316|NCT01416194|143100317|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.01|TWO_SIDED|95.0|0.2|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||0.5|0.2|<0.01
71800317|NCT01416194|143100317|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.24|TWO_SIDED|95.0|0.3|1.3|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.||1.3|0.3|0.24
71800318|NCT01222494|143100318|SUPERIORITY|||||||0.01||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.01
71800319|NCT01222494|143100319|SUPERIORITY|||||||0.04||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.04
71800320|NCT01222494|143100320|SUPERIORITY|||||||0.7||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.70
71840936|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.08||||0.5622|TWO_SIDED|95.0|-2.501|8.66|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.660|-2.501|0.5622
71840937|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.014||||0.2841|TWO_SIDED|95.0|-1.643|9.672|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||9.672|-1.643|0.2841
71840938|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|4.438||||0.0178|TWO_SIDED|95.0|0.774|8.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.103|0.774|0.0178
71840939|NCT04800211|143191002|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.847||||0.6944|TWO_SIDED|95.0|-3.398|5.093|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Serum HDL-C (mg/dL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.093|-3.398|0.6944
71840940|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-35.556||||0.0031|TWO_SIDED|95.0|-59.038|-12.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-12.075|-59.038|0.0031
71840941|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-31.35||||0.0371|TWO_SIDED|95.0|-60.818|-1.882|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.882|-60.818|0.0371
71675013|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|90.0|-1.52|-0.64||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.64|-1.52|<0.0001
71893537|NCT01309737|143308336|SUPERIORITY_OR_OTHER||Percent difference|13.62||||0.0002|TWO_SIDED|95.0|6.54|20.69|||Normal Approximation|||||20.69|6.54|0.0002
71800321|NCT01222494|143100321|SUPERIORITY|||||||0.003||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p \< 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.||||0.003
71800322|NCT02832674|143100338|SUPERIORITY|||||||0.05|TWO_SIDED|90.0|||||Fisher Exact|||The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.||||0.05
71800323|NCT02832674|143100339|OTHER|Binomial test of proportions||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
71675014|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.27||0.0175|TWO_SIDED|90.0|-1.08|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.20|-1.08|0.0175
71800324|NCT02832674|143100340|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared|||Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.|The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
71800325|NCT02832674|143100341|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
71800326|NCT02832674|143100342|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
71800327|NCT02832674|143100343|OTHER|||||||0.025|TWO_SIDED|95.0|||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.|||0.025
71800328|NCT02357576|143100418|OTHER|Percentage and frequencies were used to describe the incidence of PNAC in the two groups.||||||0.617|||||||Fisher Exact|||||||0.617
71840942|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-34.356||||0.0043|TWO_SIDED|95.0|-57.877|-10.834|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-10.834|-57.877|0.0043
71800329|NCT02357576|143100419|OTHER|Percentage and frequencies were used to describe the incidence of severe PNAC.||||||0.45|||||||Fisher Exact|||||||0.450
71800330|NCT02357576|143100420|OTHER|The Kaplan Meier curve was used to evaluated the time to first PNAC event.||||||0.2716|||||||Log Rank|A log rank test was used to test the equality of the survival curve between the two groups.||||||0.2716
71800331|NCT00414050|143100443|NON_INFERIORITY_OR_EQUIVALENCE|Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was \>= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.|Ratio of geometric means|1.99|||||TWO_SIDED|95.0|1.69|2.35||||||Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.||2.35|1.69|
71800332|NCT03495908|143100448|NON_INFERIORITY|Non-inferiority margin is 0.4% HbA1c|Mean Difference (Net)|-0.2207||||0.007|TWO_SIDED|95.0|-0.6654|0.2241||Non-inferiority p-value based on the 0.4% non-inferiority margin|Mixed Models Analysis||RHI - RAI estimated treatment difference. Upper confidence interval 0.22 is less than the 0.4% non-inferiority margin.|RHI - RAI estimated treatment difference (ETD) in HbA1c. Per-protocol analysis is the pre-specified primary outcome.||0.2241|-0.6654|0.007
71800333|NCT03495908|143100449|SUPERIORITY|Comparison of Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||||0.82|||||||Fisher Exact|||Post-randomization prevalence of hypoglycemia based on 7-point glucose profiles.||||.82
71800334|NCT03495908|143100450|SUPERIORITY|Analysis of the 7-point profiles within the ITT population (n=136)|Risk Ratio (RR)|0.925||||0.861|TWO_SIDED|95.0|0.386|2.217||Results are from a Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Regression, Poisson|Poisson regression model with repeated measures; generalized estimating equations (GEE) approach|The incidence rate ratio quantitates the risk of hypoglycemia in the RHI group (RR numerator) compared with the RAI group (RR numerator). Results from Poisson regression model with repeated measures; generalized estimating equations (GEE) approach.|Level 1 (≤70 mg/dL or (\<3.9 mmol/L)) and level 2 hypoglycemia (\<54 mg/dL (\<3.0 mmol/L)) events are analyzed. No level 3 events were reported for either group.||2.217|0.386|0.861
71800335|NCT03495908|143100451|SUPERIORITY||Mean Difference (Net)|-0.01073||||0.415|TWO_SIDED|95.0|-0.03674|0.01528|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|RHI versus RAI for Insulin Intent-to-treat Population N=136 Mixed Model Estimates for Insulin TDD U/kg I||0.01528|-0.03674|0.415
71800336|NCT03495908|143100452|SUPERIORITY||Mean Difference (Net)|-1.0776||||0.32|TWO_SIDED|95.0|-3.2139|1.0587|||Mixed Models Analysis||Between Group Comparison (RHI-RAI) Estimated Treatment Difference (ETD) mixed effects model analysis|||1.0587|-3.2139|0.320
71800337|NCT03495908|143100453|SUPERIORITY||Mean Difference (Net)|-265.85|||<|0.0001|TWO_SIDED|95.0|-288.6|-243.11|||Mixed Models Analysis||Estimated Treatment Difference (RHI-RAI) from repeated measures mixed model least squares estimates|||-243.11|-288.60|<0.0001
71800338|NCT03495908|143100454|NON_INFERIORITY|Change in A1C Non-inferiority Margin is 0.4%|Mean Difference (Net)|-0.1317||||0.02|TWO_SIDED|95.0|-0.5838|0.3205||p-value for non-inferiority|Mixed Models Analysis||Between Group Difference (RHI-RAI) mixed effects repeated measures model analysis.Upper confidence interval 0.32 is less than the 0.4% non-inferiority margin.|Intent-to-treat secondary outcome of HbA1c response for assessment of non-inferiority of RHI compared to RAI||0.3205|-0.5838|0.02
71800339|NCT03304379|143100456|SUPERIORITY||Least Square (LS) Mean Difference|-0.63|||=|0.0003|TWO_SIDED|95.0|-0.971|-0.286||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.286|-0.971|= 0.0003
71800340|NCT03304379|143100456|SUPERIORITY||LS Mean Difference|-0.77|||>|0.0001|TWO_SIDED|95.0|-1.154|-0.383||Threshold for significance at 0.05 level.|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction"||-0.383|-1.154|> 0.0001
71800341|NCT03304379|143100457|SUPERIORITY||LS Mean Difference|-0.64|||=|0.0003|TWO_SIDED|95.0|-0.981|-0.29||Threshold for significance at 0.05 level.|MMRM|||Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.||-0.290|-0.981|= 0.0003
71800342|NCT03304379|143100457|SUPERIORITY||LS Mean Difference|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.198|-0.443||Threshold for significance at 0.05 level|MMRM|||"(mFAS)~Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction."||-0.443|-1.198|<0.0001
71800343|NCT03304379|143100458|SUPERIORITY||Odds Ratio (OR)|1.581|||=|0.0013|TWO_SIDED|95.0|1.195|2.092||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.||2.092|1.195|= 0.0013
71800344|NCT03304379|143100459|SUPERIORITY||LS Mean Difference|-0.14|||=|0.0365|TWO_SIDED|95.0|-0.28|-0.009||Threshold for significance at 0.05 level.|MMRM|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.||-0.009|-0.28|= 0.0365
71800345|NCT01298063|143100475|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|92.64|STANDARD_DEVIATION|33.6||0.1998|TWO_SIDED|90.0|67.96|126.27||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||126.270|67.960|0.1998
71800346|NCT01298063|143100475|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.88|STANDARD_DEVIATION|31.6||0.144|TWO_SIDED|90.0|72.278|124.549||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.549|72.278|0.1440
71800347|NCT01298063|143100476|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|109.47|STANDARD_DEVIATION|30.3||0.2002|TWO_SIDED|90.0|82.683|144.947||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||144.947|82.683|0.2002
71800348|NCT01298063|143100476|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|126.89|STANDARD_DEVIATION|42.8||0.5281|TWO_SIDED|90.0|86.028|187.159||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||187.159|86.028|0.5281
71800349|NCT01298063|143100477|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|90.61|STANDARD_DEVIATION|32.8||0.2309|TWO_SIDED|90.0|66.915|122.705||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||122.705|66.915|0.2309
71800350|NCT01298063|143100477|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|Geometric mean ratio|94.49|STANDARD_DEVIATION|32.4||0.1546|TWO_SIDED|90.0|71.563|124.764||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation|||124.764|71.563|0.1546
71800351|NCT00780572|143100500|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9396||||0.668|TWO_SIDED|95.0|0.7068|1.249|||Regression, Cox|||||1.2490|0.7068|0.6680
71800352|NCT01469065|143100501|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|84.87|||||TWO_SIDED|90.0|78.16|92.15||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test. Formal statistical inference was not performed thus p value was not reported.||92.15|78.16|
71800353|NCT01469065|143100501|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|89.8|||||TWO_SIDED|90.0|82.69|97.53||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.53|82.69|
71800354|NCT01469065|143100501|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.15|||||TWO_SIDED|90.0|80.27|94.63||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.63|80.27|
71675015|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.68|STANDARD_ERROR_OF_MEAN|0.27||0.0125|TWO_SIDED|90.0|-1.13|-0.23||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.23|-1.13|0.0125
71675016|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.27||0.1457|TWO_SIDED|90.0|-0.84|0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||0.05|-0.84|0.1457
71800355|NCT01469065|143100501|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|78.28|||||TWO_SIDED|90.0|72.06|85.03||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||85.03|72.06|
71800356|NCT01469065|143100514|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|82.69|||||TWO_SIDED|90.0|76.06|89.9||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||89.90|76.06|
71800357|NCT01469065|143100514|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.39|||||TWO_SIDED|90.0|78.6|92.77||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.77|78.60|
71800358|NCT01469065|143100514|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|85.37|||||TWO_SIDED|90.0|78.59|92.76||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.76|78.59|
71800359|NCT01469065|143100514|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|75.82|||||TWO_SIDED|90.0|69.78|82.39||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||82.39|69.78|
71800360|NCT01469065|143100514|SUPERIORITY_OR_OTHER||Difference between Test and Reference|-35.84|||||TWO_SIDED|90.0|-52.89|-18.78||||||Treatment difference and 90% confidence interval (CI) were based on adjusted geometric mean.||-18.78|-52.89|
71800361|NCT01469065|143100515|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|86.72|||||TWO_SIDED|90.0|81.13|92.7||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||92.70|81.13|
71675017|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.28||0.0003|TWO_SIDED|90.0|-1.48|-0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.57|-1.48|0.0003
71800362|NCT01469065|143100515|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.13|||||TWO_SIDED|90.0|85.24|97.44||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.44|85.24|
71800363|NCT01469065|143100515|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|87.05|||||TWO_SIDED|90.0|81.44|93.04||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.04|81.44|
71675018|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.28||0.0002|TWO_SIDED|90.0|-1.49|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.58|-1.49|0.0002
71800364|NCT01469065|143100515|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|77.95|||||TWO_SIDED|90.0|72.91|83.34||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||83.34|72.91|
71800365|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|100.04|||||TWO_SIDED|90.0|92.7|107.96||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.96|92.70|
71800366|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|99.44|||||TWO_SIDED|90.0|92.04|107.43||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.43|92.04|
71675019|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|90.0|-1.63|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.69|-1.63|<0.0001
71675020|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.28||0.0196|TWO_SIDED|90.0|-1.14|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.20|-1.14|0.0196
71800367|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|101.67|||||TWO_SIDED|90.0|94.1|109.84||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.84|94.10|
71800368|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 2|96.82|||||TWO_SIDED|90.0|89.69|104.52||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.52|89.69|
71800369|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|95.85|||||TWO_SIDED|90.0|88.82|103.44||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.44|88.82|
71800370|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|98.71|||||TWO_SIDED|90.0|91.37|106.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||106.64|91.37|
71800371|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|99.72|||||TWO_SIDED|90.0|92.3|107.73||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.73|92.30|
71800372|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 3|94.49|||||TWO_SIDED|90.0|87.53|102.1||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.10|87.53|
71800373|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|93.43|||||TWO_SIDED|90.0|86.5|100.91||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.91|86.50|
71800374|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|92.71|||||TWO_SIDED|90.0|85.81|100.15||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.15|85.81|
71800375|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|94.08|||||TWO_SIDED|90.0|87.08|101.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||101.64|87.08|
71800376|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 6|87.74|||||TWO_SIDED|90.0|81.2|94.81||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.81|81.20|
71800377|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.91|||||TWO_SIDED|90.0|89.72|104.67||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.67|89.72|
71840943|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-18.096||||0.2091|TWO_SIDED|95.0|-46.375|10.183|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||10.183|-46.375|0.2091
71675021|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.01|STANDARD_ERROR_OF_MEAN|0.3||0.0007|TWO_SIDED|90.0|-1.5|-0.52||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.52|-1.50|0.0007
71800378|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|96.05|||||TWO_SIDED|90.0|88.9|103.76||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||103.76|88.90|
71800379|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|99.63|||||TWO_SIDED|90.0|92.21|107.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||107.64|92.21|
71800380|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 10|94.5|||||TWO_SIDED|90.0|87.46|102.11||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.11|87.46|
71800381|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|86.75|||||TWO_SIDED|90.0|80.32|93.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||93.69|80.32|
71800382|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|87.87|||||TWO_SIDED|90.0|81.34|94.93||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||94.93|81.34|
71800383|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|91.35|||||TWO_SIDED|90.0|84.55|98.7||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.70|84.55|
71800384|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 14|88.6|||||TWO_SIDED|90.0|82.0|95.74||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||95.74|82.00|
71800385|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|83.75|97.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||97.69|83.75|
71800386|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|90.45|||||TWO_SIDED|90.0|84.03|98.08||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||98.08|84.03|
71893538|NCT01309737|143308337|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.44|STANDARD_ERROR_OF_MEAN|13.62||0.0062|TWO_SIDED|95.0|-64.19|-10.68||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-10.68|-64.19|0.0062
71675022|NCT01164579|142867600|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.3||0.0049|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.35|-1.32|0.0049
71800387|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|94.75|||||TWO_SIDED|90.0|87.69|102.34||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||102.34|87.69|
71800388|NCT01469065|143100516|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%) at Day 15|93.18|||||TWO_SIDED|90.0|86.17|100.77||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.77|86.17|
71800389|NCT01469065|143100517|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|112.83|||||TWO_SIDED|90.0|99.84|127.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||127.50|99.84|
71800390|NCT01469065|143100517|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|102.11|||||TWO_SIDED|90.0|90.78|114.85||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||114.85|90.78|
71800391|NCT01469065|143100517|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|111.04|||||TWO_SIDED|90.0|98.5|125.18||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||125.18|98.50|
71800392|NCT01469065|143100517|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.73|||||TWO_SIDED|90.0|85.46|109.48||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||109.48|85.46|
71800393|NCT01469065|143100518|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|107.13|||||TWO_SIDED|90.0|98.69|116.3||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||116.30|98.69|
71800394|NCT01469065|143100518|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|92.57|||||TWO_SIDED|90.0|85.26|100.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||100.50|85.26|
71800395|NCT01469065|143100518|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|96.07|||||TWO_SIDED|90.0|88.51|104.27||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||104.27|88.51|
71800396|NCT01469065|143100518|SUPERIORITY_OR_OTHER||Test-to-Reference Ratio (%)|91.7|||||TWO_SIDED|90.0|84.38|99.65||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.||99.65|84.38|
71800397|NCT03022617|143100528|SUPERIORITY||Mean Difference (Final Values)|21.5|STANDARD_DEVIATION|10.89||0.05|TWO_SIDED||||||t-test, 2 sided|||||||.05
71840944|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-24.723||||0.0197|TWO_SIDED|95.0|-45.473|-3.973|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-3.973|-45.473|0.0197
71800398|NCT00515827|143100548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||95.0||||P-value is 2-sided and is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||||0.546
71800399|NCT01833403|143100557|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71800400|NCT01032135|143100563|OTHER|||||||0.11|||||||Chi-squared|||||||0.11
71800401|NCT01032135|143100564|OTHER|||||||0.02|||||||Chi-squared|||||||0.02
71800402|NCT01032135|143100565|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
71800403|NCT01032135|143100570|OTHER||Odds Ratio (OR)|0.4||||0.0007|TWO_SIDED|95.0|0.23|0.68|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.68|0.23|0.0007
71800404|NCT01032135|143100570|OTHER||Odds Ratio (OR)|0.54||||0.16|TWO_SIDED|95.0|0.23|1.27|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.27|0.23|0.16
71800405|NCT01032135|143100570|OTHER||Odds Ratio (OR)|1.12||||0.79|TWO_SIDED|95.0|0.48|2.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.60|0.48|0.79
71800406|NCT01032135|143100575|OTHER||Odds Ratio (OR)|-1.08||||0.009|TWO_SIDED|95.0|-1.87|-0.29|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.29|-1.87|0.009
71800407|NCT01032135|143100575|OTHER||Odds Ratio (OR)|-0.84||||0.23|TWO_SIDED|95.0|-2.2|0.52|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.52|-2.20|0.23
71800408|NCT01032135|143100575|OTHER||Odds Ratio (OR)|-0.34||||0.58|TWO_SIDED|95.0|-1.52|0.85|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.85|-1.52|0.58
71800409|NCT01032135|143100580|OTHER||Odds Ratio (OR)|0.33||||0.0001|TWO_SIDED|95.0|0.19|0.58|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.58|0.19|0.0001
71800410|NCT01032135|143100580|OTHER||Odds Ratio (OR)|0.67||||0.36|TWO_SIDED|95.0|0.29|1.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.54|0.29|0.36
71675023|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.53|0.15||||||Baseline||0.15|-0.53|
71675024|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|90.0|-0.24|0.36||||||Baseline||0.36|-0.24|
71675025|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||||TWO_SIDED|90.0|-1.4|-0.42||||||Month 1||-0.42|-1.40|
71675026|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|||||TWO_SIDED|90.0|-1.01|-0.14||||||Month 1||-0.14|-1.01|
71800411|NCT01032135|143100580|OTHER||Odds Ratio (OR)|1.43||||0.45|TWO_SIDED|95.0|0.58|3.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.54|0.58|0.45
71800412|NCT01032135|143100585|OTHER||Odds Ratio (OR)|-1.09||||0.003|TWO_SIDED|95.0|-1.8|-0.39|||Chi-squared|||The statistical analyses used data from all follow up assessments.||-0.39|-1.80|0.003
71800413|NCT01032135|143100585|OTHER||Odds Ratio (OR)|0.02||||0.1|TWO_SIDED|95.0|-1.1|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|-1.10|0.10
71800414|NCT01032135|143100589|OTHER||Odds Ratio (OR)|0.66||||0.13|TWO_SIDED|95.0|0.38|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.||1.14|0.38|0.13
71800415|NCT01032135|143100589|OTHER||Odds Ratio (OR)|0.83||||0.71|TWO_SIDED|95.0|0.33|2.12|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.12|0.33|0.71
71800416|NCT01032135|143100589|OTHER||Odds Ratio (OR)|1.48||||0.36|TWO_SIDED|95.0|0.64|3.4|||Chi-squared|||The statistical analyses used data from all follow up assessments.||3.40|0.64|0.36
71840945|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-13.595||||0.2353|TWO_SIDED|95.0|-36.08|8.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||8.891|-36.080|0.2353
71675027|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|90.0|-1.82|-0.73||||||Month 2||-0.73|-1.82|
71675028|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|90.0|-1.25|-0.13||||||Month 2||-0.13|-1.25|
71675029|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||||TWO_SIDED|90.0|-1.55|-0.38||||||Month 3||-0.38|-1.55|
71675030|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|90.0|-1.12|0.11||||||Month 3||0.11|-1.12|
71675031|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43|||||TWO_SIDED|90.0|-2.13|-0.72||||||Month 6||-0.72|-2.13|
71675032|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|||||TWO_SIDED|90.0|-1.91|-0.57||||||Month 6||-0.57|-1.91|
71675033|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 9||-0.39|-1.84|
71675034|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|90.0|-1.3|0.13||||||Month 9||0.13|-1.30|
71675035|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11|||||TWO_SIDED|90.0|-1.84|-0.39||||||Month 12||-0.39|-1.84|
71800417|NCT01032135|143100592|OTHER||Odds Ratio (OR)|-0.13||||0.75|TWO_SIDED|95.0|-0.94|0.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.60|-0.94|0.75
71800418|NCT01032135|143100592|OTHER||Odds Ratio (OR)|-0.84||||0.16|TWO_SIDED|95.0|-1.98|0.3|||Chi-squared|||The statistical analyses used data from all follow up assessments.||0.30|-1.98|0.16
71800419|NCT01032135|143100592|OTHER||Odds Ratio (OR)|0.6||||0.42|TWO_SIDED|95.0|-0.85|2.04|||Chi-squared|||The statistical analyses used data from all follow up assessments.||2.04|-0.85|0.42
71800420|NCT02553746|143100599|SUPERIORITY|||||||0.748|||||||Chi-squared, Corrected|||||||0.748
71800421|NCT02553746|143100600|SUPERIORITY|||||||0.498|||||||Chi-squared, Corrected|||||||0.498
71800422|NCT02553746|143100601|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
71800423|NCT02553746|143100602|SUPERIORITY|||||||0.162|||||||Wilcoxon (Mann-Whitney)|||||||0.162
71800424|NCT02553746|143100603|SUPERIORITY|||||||0.104|||||||Chi-squared, Corrected|||||||0.104
71800425|NCT02553746|143100604|SUPERIORITY||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||||||<0.005
71800426|NCT01227512|143100611|SUPERIORITY_OR_OTHER|||||||0.9495||||||The alpha level was set at 0.05|Generalized Wilcoxon Test|Participants who used rescue therapy within first 7 days of treatment period were censored at time they started the rescue therapy.||||||0.9495
71800427|NCT01227512|143100612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.146||95.0|-0.7|0.11||alpha level was set at 0.05. p-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|Includes factors of treatment, study center and covariate baseline.||||0.11|-0.70|0.1460
71800428|NCT01227512|143100613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.315||95.0|-0.57|0.19|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 24 hours post-dose.||0.19|-0.57|0.3150
71800429|NCT01227512|143100613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.5381||95.0|-0.57|0.3|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 72 hours post-dose.||0.30|-0.57|0.5381
71800430|NCT01227512|143100614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.2702||95.0|-0.73|0.21||P-value was derived from a Cochran-Mantel-Haenszel (CMH) row mean scores test.|Cochran-Mantel-Haenszel|||||0.21|-0.73|0.2702
71800431|NCT01227512|143100615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77||||0.0019||95.0|1.43|6.11||P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|||||6.11|1.43|0.0019
71893539|NCT01309737|143308337|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|13.75||0.0025|TWO_SIDED|95.0|-68.8|-14.78||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.||-14.78|-68.80|0.0025
71675036|NCT01164579|142867601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|90.0|-1.43|0.11||||||Month 12||0.11|-1.43|
71800432|NCT01227512|143100616|SUPERIORITY_OR_OTHER|||||||0.5128||||||p-value was derived from Generalized Wilcoxon test stratified by treatment. Participants who received rescue therapy were censored at the time of receiving rescue therapy.|Generalized Wilcoxon Test|||||||0.5128
71800433|NCT01227512|143100617|SUPERIORITY_OR_OTHER||Relative Risk|1.1||||0.5795||95.0|0.79|1.52||P-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.52|0.79|0.5795
71800434|NCT01227512|143100618|SUPERIORITY_OR_OTHER||Relative Risk|0.33||||0.1568||95.0|0.07|1.65||p-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel|||||1.65|0.07|0.1568
71800435|NCT04497987|143100651|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.26|0.63|||Regression, Logistic|||||0.63|0.26|<0.001
71800436|NCT04497987|143100652|SUPERIORITY||Odds Ratio (OR)|0.43|||<|0.001|TWO_SIDED|95.0|0.27|0.67|||Regression, Logistic|||||0.67|0.27|<0.001
71800437|NCT04497987|143100653|SUPERIORITY||Odds Ratio (OR)|0.66||||0.021|TWO_SIDED|95.0|0.46|0.94|||Regression, Logistic|||||0.94|0.46|0.021
71800438|NCT04035486|143100682|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.79|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.79|0.49|<0.0001
71800439|NCT04035486|143100683|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0002|TWO_SIDED|95.0|0.48|0.8|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.80|0.48|0.0002
71800440|NCT04035486|143100688|OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|88.43|100.0|||Clopper-Pearson|||A 95% CI was calculated on the percentage of participants with a Response or Stable Disease using the exact (Clopper-Pearson) method.||100.00|88.43|
71800441|NCT04035486|143100689|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5238|TWO_SIDED|95.0|0.65|1.24|||Log Rank||A hazard ratio of less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).|An adjusted CI of (0.54, 1.51) was computed at the 2-sided 99.84% level, considering a 2-sided significance level of 0.00158 for the overall survival interim analysis, based on the O'Brien and Fleming spending function, assuming 334 deaths for the final overall survival analysis.|1.24|0.65|0.5238
71800442|NCT04035486|143100691|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0261|TWO_SIDED|95.0|1.06|2.44|||Regression, Logistic||And odds ratio of greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.44|1.06|0.0261
71800443|NCT04035486|143100693|SUPERIORITY||Least Square Mean Difference|-3.36||||0.1067|TWO_SIDED|95.0|-7.44|0.72|||ANCOVA||A difference in least square means less than 0 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using analysis of covariance with baseline tumor size and time from baseline scan to randomization as covariates and with factors race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.72|-7.44|0.1067
71800444|NCT04035486|143100694|SUPERIORITY||Odds Ratio (OR)|1.33||||0.4483|TWO_SIDED|95.0|0.63|2.81|||Regression, Logistic||An odds ratio greater than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a logistic regression stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||2.81|0.63|0.4483
71800445|NCT04035486|143100695|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0132|TWO_SIDED|95.0|0.52|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.52|0.0132
71800446|NCT04035486|143100696|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0159|TWO_SIDED|95.0|0.56|0.94|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.94|0.56|0.0159
71800447|NCT04035486|143100697|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0157|TWO_SIDED|95.0|0.51|0.93|||Log Rank||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|The analysis was performed using a log rank test stratified by race (Chinese/Asian vs. Non-Chinese/Asian vs. Non-Asian), WHO performance status (0 vs. 1), and method used for tissue testing (central vs. local).||0.93|0.51|0.0157
71675037|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.29||0.0046|TWO_SIDED|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.35|-1.32|0.0046
71675038|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.29||0.0303|TWO_SIDED|90.0|-1.11|-0.15||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1||-0.15|-1.11|0.0303
71800448|NCT04035486|143100704|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.83|||Cox proportional hazards model||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.83|0.44|
71800449|NCT04035486|143100705|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.44|0.9|||||A hazard ratio less than 1 favors the Osimertinib (AZD9291) + Chemo treatment arm.|Subgroup analysis was performed using a Cox proportional hazards model including treatment, subgroup and a treatment-by subgroup interaction term.||0.90|0.44|
71800450|NCT01312909|143100732|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6337|TWO_SIDED|95.0|0.59|2.37||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||2.37|0.59|0.6337
71800451|NCT01312909|143100732|SUPERIORITY||Odds Ratio (OR)|1.73||||0.1114|TWO_SIDED|95.0|0.88|3.39||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.||3.39|0.88|0.1114
71800452|NCT01312909|143100733|SUPERIORITY||Odds Ratio (OR)|1.21||||0.5793|TWO_SIDED|95.0|0.62|2.38|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||2.38|0.62|0.5793
71800453|NCT01312909|143100733|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0932|TWO_SIDED|95.0|0.91|3.51|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12||3.51|0.91|0.0932
71800454|NCT01312909|143100733|SUPERIORITY||Odds Ratio (OR)|1.23||||0.5647|TWO_SIDED|95.0|0.61|2.5|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.50|0.61|0.5647
71800455|NCT01312909|143100733|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2917|TWO_SIDED|95.0|0.72|2.96|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24||2.96|0.72|0.2917
71800456|NCT01312909|143100733|SUPERIORITY||Odds Ratio (OR)|1.25||||0.5616|TWO_SIDED|95.0|0.58|2.69|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||2.69|0.58|0.5616
71800457|NCT01312909|143100733|SUPERIORITY||Odds Ratio (OR)|1.79||||0.13|TWO_SIDED|95.0|0.84|3.78|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52||3.78|0.84|0.1300
71800458|NCT01312909|143100735|SUPERIORITY||Least square (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.58||0.354|TWO_SIDED|95.0|-1.69|0.6|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.60|-1.69|0.3540
71800459|NCT01312909|143100735|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.59||0.7574|TWO_SIDED|95.0|-1.35|0.98|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.98|-1.35|0.7574
71800460|NCT01312909|143100735|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.6||0.5676|TWO_SIDED|95.0|-1.53|0.84|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.84|-1.53|0.5676
71800461|NCT01312909|143100735|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.61||0.2356|TWO_SIDED|95.0|-1.92|0.47|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.47|-1.92|0.2356
71800462|NCT01312909|143100735|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.62||0.773|TWO_SIDED|95.0|-1.03|1.38|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||1.38|-1.03|0.7730
71800463|NCT01312909|143100735|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.62||0.2166|TWO_SIDED|95.0|-1.99|0.45|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.||0.45|-1.99|0.2166
71800464|NCT01312909|143100736|SUPERIORITY||Odds Ratio (OR)|0.8||||0.6133|TWO_SIDED|95.0|0.34|1.9|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||1.90|0.34|0.6133
71800465|NCT01312909|143100736|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0335|TWO_SIDED|95.0|1.07|4.79|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||4.79|1.07|0.0335
71800466|NCT01312909|143100736|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9874|TWO_SIDED|95.0|0.37|2.65|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||2.65|0.37|0.9874
71675039|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.18|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|90.0|-1.69|-0.68||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.68|-1.69|0.0001
71675040|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.3||0.0255|TWO_SIDED|90.0|-1.17|-0.18||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2||-0.18|-1.17|0.0255
71675041|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.3||0.0035|TWO_SIDED|90.0|-1.39|-0.39||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.39|-1.39|0.0035
71675042|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.3||0.0683|TWO_SIDED|90.0|-1.05|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3||-0.05|-1.05|0.0683
71675043|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.29|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|90.0|-1.81|-0.78||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.78|-1.81|<0.0001
71675044|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.08|STANDARD_ERROR_OF_MEAN|0.31||0.0006|TWO_SIDED|90.0|-1.59|-0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6||-0.56|-1.59|0.0006
71675045|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0004|TWO_SIDED|90.0|-1.67|-0.62||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.62|-1.67|0.0004
71675046|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.32||0.0706|TWO_SIDED|90.0|-1.1|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9||-0.05|-1.10|0.0706
71675047|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.13|STANDARD_ERROR_OF_MEAN|0.33||0.0008|TWO_SIDED|90.0|-1.67|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.58|-1.67|0.0008
71675048|NCT01164579|142867602|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.33||0.0466|TWO_SIDED|90.0|-1.21|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12||-0.12|-1.21|0.0466
71800467|NCT01312909|143100736|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0188|TWO_SIDED|95.0|1.19|6.55|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.||6.55|1.19|0.0188
71675049|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.51|STANDARD_ERROR_OF_MEAN|11.04||0.0032|TWO_SIDED|90.0|14.34|50.68||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||50.68|14.34|0.0032
71675050|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.18|STANDARD_ERROR_OF_MEAN|11.16||0.0115|TWO_SIDED|90.0|9.81|46.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||46.55|9.81|0.0115
71800468|NCT00127790|143100780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||0.01|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.010
71675051|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||50.02|18.81|0.0002
71675052|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.79|STANDARD_ERROR_OF_MEAN|10.48||0.0231|TWO_SIDED|90.0|6.55|41.03||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||41.03|6.55|0.0231
71675053|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.41|STANDARD_ERROR_OF_MEAN|9.48||0.0002|TWO_SIDED|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||50.02|18.81|0.0002
71675054|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|10.69||0.0493|TWO_SIDED|90.0|3.43|38.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||38.61|3.43|0.0493
71675055|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.18|STANDARD_ERROR_OF_MEAN|9.88||0.0005|TWO_SIDED|90.0|17.92|50.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.43|17.92|0.0005
71675056|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.72|STANDARD_ERROR_OF_MEAN|10.73||0.027|TWO_SIDED|90.0|6.07|41.37||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||41.37|6.07|0.0270
71675057|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||51.12|15.80|0.0018
71675058|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||41.96|5.02|0.0363
71675059|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||53.64|19.16|0.0005
71675060|NCT01164579|142867603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||44.50|8.04|0.0177
71675061|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.52|STANDARD_ERROR_OF_MEAN|9.66||0.0197|TWO_SIDED|90.0|6.62|38.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||38.42|6.62|0.0197
71675062|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_ERROR_OF_MEAN|8.16||0.4379|TWO_SIDED|90.0|-7.09|19.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||19.76|-7.09|0.4379
71675063|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||46.34|10.40|0.0093
71800469|NCT00127790|143100780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.581|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.581
71675064|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|10.48||0.1669|TWO_SIDED|90.0|-2.75|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||31.73|-2.75|0.1669
71675065|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.37|STANDARD_ERROR_OF_MEAN|10.92||0.0093|TWO_SIDED|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||46.34|10.40|0.0093
71675066|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.04|STANDARD_ERROR_OF_MEAN|10.64||0.0596|TWO_SIDED|90.0|2.53|37.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||37.55|2.53|0.0596
71675067|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||52.96|16.51|0.0017
71675068|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.52|STANDARD_ERROR_OF_MEAN|11.04||0.0097|TWO_SIDED|90.0|10.36|46.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||46.69|10.36|0.0097
71675069|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.97|STANDARD_ERROR_OF_MEAN|11.11||0.0016|TWO_SIDED|90.0|16.68|53.26||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.26|16.68|0.0016
71675070|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.6|STANDARD_ERROR_OF_MEAN|11.13||0.0102|TWO_SIDED|90.0|10.28|46.91||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||46.91|10.28|0.0102
71675071|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.73|STANDARD_ERROR_OF_MEAN|11.07||0.0017|TWO_SIDED|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||52.96|16.51|0.0017
71675072|NCT01164579|142867604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.97|STANDARD_ERROR_OF_MEAN|11.07||0.0381|TWO_SIDED|90.0|4.74|41.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.19|4.74|0.0381
71675073|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|7.67||0.0959|TWO_SIDED|90.0|0.15|25.4||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||25.40|0.15|0.0959
71675074|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|5.4||0.9544|TWO_SIDED|90.0|-8.58|9.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||9.19|-8.58|0.9544
71675075|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
71675076|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|7.66||0.264|TWO_SIDED|90.0|-4.04|21.16||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||21.16|-4.04|0.2640
71675077|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
71675078|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|8.92||0.329|TWO_SIDED|90.0|-5.96|23.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||23.38|-5.96|0.3290
71675079|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.84|STANDARD_ERROR_OF_MEAN|10.48||0.0032|TWO_SIDED|90.0|13.59|48.09||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||48.09|13.59|0.0032
71675080|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.11|STANDARD_ERROR_OF_MEAN|9.92||0.0845|TWO_SIDED|90.0|0.79|33.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||33.43|0.79|0.0845
71675081|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.08|STANDARD_ERROR_OF_MEAN|10.72||0.0037|TWO_SIDED|90.0|13.44|48.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||48.72|13.44|0.0037
71675082|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96|STANDARD_ERROR_OF_MEAN|10.36||0.054|TWO_SIDED|90.0|2.91|37.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||37.02|2.91|0.0540
71675083|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.54|STANDARD_ERROR_OF_MEAN|10.24||0.001|TWO_SIDED|90.0|16.7|50.39||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||50.39|16.70|0.0010
71675084|NCT01164579|142867605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.81|STANDARD_ERROR_OF_MEAN|9.66||0.0401|TWO_SIDED|90.0|3.92|35.71||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||35.71|3.92|0.0401
71675085|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.91|STANDARD_ERROR_OF_MEAN|10.99||0.0005|TWO_SIDED|90.0|19.83|55.99||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||55.99|19.83|0.0005
71675086|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.12|STANDARD_ERROR_OF_MEAN|11.09||0.0028|TWO_SIDED|90.0|14.87|51.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||51.38|14.87|0.0028
71675087|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.83|STANDARD_ERROR_OF_MEAN|10.1||0.0105|TWO_SIDED|90.0|9.21|42.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.45|9.21|0.0105
71675088|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|STANDARD_ERROR_OF_MEAN|11.13||0.37|TWO_SIDED|90.0|-8.33|28.3||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||28.30|-8.33|0.3700
71675089|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.82|STANDARD_ERROR_OF_MEAN|9.54|<|0.0001|TWO_SIDED|90.0|24.11|55.53||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||55.53|24.11|<0.0001
71675090|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.09|STANDARD_ERROR_OF_MEAN|11.24||0.1076|TWO_SIDED|90.0|-0.4|36.59||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||36.59|-0.40|0.1076
71675091|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.94|STANDARD_ERROR_OF_MEAN|10.21||0.0008|TWO_SIDED|90.0|17.13|50.75||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||50.75|17.13|0.0008
71675092|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.42|STANDARD_ERROR_OF_MEAN|10.74||0.0139|TWO_SIDED|90.0|8.74|44.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||44.10|8.74|0.0139
71675093|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.4|STANDARD_ERROR_OF_MEAN|10.48||0.0005|TWO_SIDED|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||53.64|19.16|0.0005
71675094|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.27|STANDARD_ERROR_OF_MEAN|11.08||0.0177|TWO_SIDED|90.0|8.04|44.5|||Normal approximation to the binomial|||Month 9||44.50|8.04|0.0177
71675095|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.46|STANDARD_ERROR_OF_MEAN|10.73||0.0018|TWO_SIDED|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.12|15.80|0.0018
71800470|NCT00127790|143100780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.011|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.011
71800471|NCT00127790|143100781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.33|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.33
71800472|NCT00127790|143100781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.112|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.112
71800473|NCT00127790|143100781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.737|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.737
71800474|NCT00127790|143100782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.063|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.063
71893540|NCT01309737|143308337|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.35|STANDARD_ERROR_OF_MEAN|10.98||0.692|TWO_SIDED|95.0|-25.91|17.21|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.||17.21|-25.91|0.6920
71675096|NCT01164579|142867606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.49|STANDARD_ERROR_OF_MEAN|11.22||0.0363|TWO_SIDED|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||41.96|5.02|0.0363
71675097|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.88|STANDARD_ERROR_OF_MEAN|7.42||0.016|TWO_SIDED|90.0|5.66|30.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||30.10|5.66|0.0160
71675098|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|5.43||0.2798|TWO_SIDED|90.0|-3.06|14.8||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||14.80|-3.06|0.2798
71675099|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.18|STANDARD_ERROR_OF_MEAN|9.34||0.0036|TWO_SIDED|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||42.55|11.81|0.0036
71800475|NCT00127790|143100782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.786|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores||||0.786
71800476|NCT00127790|143100782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.039|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.039
71800477|NCT00127790|143100783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.2||||0.016|||||||Generlaized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.016
71800478|NCT00127790|143100783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4||||0.187|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.187
71800479|NCT00127790|143100783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2||||0.015|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.||||0.015
71800480|NCT00451282|143100789|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
71800481|NCT00451282|143100790|SUPERIORITY_OR_OTHER|||||||0.89|||||||t-test, 2 sided|||||||.89
71800482|NCT00451282|143100791|SUPERIORITY_OR_OTHER|||||||0.69|||||||t-test, 2 sided|||||||.69
71800483|NCT00451282|143100792|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||.18
71800484|NCT02732847|143100827|OTHER|Chi square tests used to compared groups||||||0.924||||||A p-value of \< 0.05 was considered|Chi-squared|||||||0.924
71800485|NCT04574362|143100828|SUPERIORITY||Risk Difference (RD)|9.2|||<|0.0001|TWO_SIDED|95.0|5.4|13.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95 percent (%) confidence interval (CI) were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||13.0|5.4|<0.0001
71800486|NCT04574362|143100829|SUPERIORITY||Risk Difference (RD)|14.8|||<|0.0001|TWO_SIDED|95.0|9.6|20.0|||Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||20.0|9.6|<0.0001
71800487|NCT04574362|143100830|SUPERIORITY||Risk Difference (RD)|18.1|||<|0.0001|TWO_SIDED|95.0|13.0|23.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||23.3|13.0|<0.0001
71800488|NCT04574362|143100831|SUPERIORITY||Risk Difference (RD)|16.9|||<|0.0001|TWO_SIDED|95.0|11.4|22.3|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||22.3|11.4|<0.0001
71800489|NCT04574362|143100832|SUPERIORITY||Risk Difference (RD)|-11.5|||<|0.0001|TWO_SIDED|95.0|-15.0|-8.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||-8.0|-15.0|<0.0001
71893541|NCT01309737|143308341|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71893542|NCT01309737|143308341|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71893543|NCT01309737|143308341|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71893544|NCT01309737|143308342|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71675100|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.78|STANDARD_ERROR_OF_MEAN|7.3||0.4287|TWO_SIDED|90.0|-6.23|17.79||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||17.79|-6.23|0.4287
71675101|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||34.95|2.72|0.0544
71675102|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.04|STANDARD_ERROR_OF_MEAN|9.51||0.0732|TWO_SIDED|90.0|1.39|32.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||32.69|1.39|0.0732
71675103|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.25|STANDARD_ERROR_OF_MEAN|10.61||0.036|TWO_SIDED|90.0|4.79|39.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||39.72|4.79|0.0360
71675104|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.85|STANDARD_ERROR_OF_MEAN|9.85||0.3688|TWO_SIDED|90.0|-7.35|25.07||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||25.07|-7.35|0.3688
71675105|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.19|STANDARD_ERROR_OF_MEAN|10.67||0.0182|TWO_SIDED|90.0|7.63|42.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||42.76|7.63|0.0182
71675106|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|STANDARD_ERROR_OF_MEAN|10.15||0.1558|TWO_SIDED|90.0|-2.29|31.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||31.12|-2.29|0.1558
71675107|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.78|STANDARD_ERROR_OF_MEAN|10.49||0.0012|TWO_SIDED|90.0|16.51|51.05||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||51.05|16.51|0.0012
71675108|NCT01164579|142867607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.33|STANDARD_ERROR_OF_MEAN|9.78||0.1426|TWO_SIDED|90.0|-1.74|30.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||30.42|-1.74|0.1426
71675109|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|4.03||0.1449|TWO_SIDED|90.0|-0.75|12.52||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||12.52|-0.75|0.1449
71675110|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|2.81||0.3102|TWO_SIDED|90.0|-1.77|7.48||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1||7.48|-1.77|0.3102
71675111|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.94|STANDARD_ERROR_OF_MEAN|7.06||0.0342|TWO_SIDED|90.0|3.32|26.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||26.55|3.32|0.0342
71675112|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|4.65||0.54|TWO_SIDED|90.0|-4.8|10.51||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2||10.51|-4.80|0.5400
71675113|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.01|STANDARD_ERROR_OF_MEAN|9.19||0.2759|TWO_SIDED|90.0|-5.1|25.13||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||25.13|-5.10|0.2759
71675114|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|6.25||0.0859|TWO_SIDED|90.0|-21.02|-0.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3||-0.45|-21.02|0.0859
71675115|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.89|STANDARD_ERROR_OF_MEAN|9.62||0.0985|TWO_SIDED|90.0|0.06|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||31.73|0.06|0.0985
71675116|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|8.05||0.9628|TWO_SIDED|90.0|-12.86|13.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6||13.61|-12.86|0.9628
71675117|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|STANDARD_ERROR_OF_MEAN|10.19||0.0612|TWO_SIDED|90.0|2.31|35.84||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||35.84|2.31|0.0612
71675118|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|8.36||0.7807|TWO_SIDED|90.0|-16.08|11.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9||11.43|-16.08|0.7807
71675119|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.83|STANDARD_ERROR_OF_MEAN|9.79||0.0544|TWO_SIDED|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||34.95|2.72|0.0544
71675120|NCT01164579|142867608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|STANDARD_ERROR_OF_MEAN|8.66||0.4937|TWO_SIDED|90.0|-8.32|20.18||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12||20.18|-8.32|0.4937
71675121|NCT01605552|142867630|SUPERIORITY|||||||0.21|||||||ANCOVA||||Cohen's d = 0.61|||.21
71675122|NCT01605552|142867631|SUPERIORITY|||||||0.019|||||||ANCOVA||||Cohen's d = 1.33|||.019
71675123|NCT01605552|142867632|SUPERIORITY|||||||0.09|||||||ANCOVA||||Cohen's d = 0.78|||.09
71675124|NCT01605552|142867633|SUPERIORITY|||||||0.43|||||||ANCOVA||||Cohen's d = 0.43|||.43
71675125|NCT03491462|142867638|SUPERIORITY|||||||0.6208|||||||Gehan's extended Wilcoxon's test|||||||0.6208
71675126|NCT03018080|142867657|OTHER|Estimation only.|Rate|0.238|||||TWO_SIDED|95.0|0.082|0.472|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.472|0.082|
71675127|NCT03018080|142867657|OTHER|Estimation only.|Rate|0.316|||||TWO_SIDED|95.0|0.126|0.566|||||Confidence interval estimated using the Clopper Pearson method.|The reported grade 3/4 toxicity rate with weekly paclitaxel was 0.35. If it became evident that the grade 3/4 treatment-related toxicity rate on either arm convincingly exceeded 0.35, the study arm would have been halted. Convincing evidence of exceeding 0.35 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.50 or higher.||0.566|0.126|
71893545|NCT01309737|143308342|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71893546|NCT01309737|143308342|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71893547|NCT01309737|143308343|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71800490|NCT04574362|143100833|SUPERIORITY||Risk Difference (RD)|7.7|||<|0.0001|TWO_SIDED|95.0|4.3|11.2|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk differences and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.2|4.3|<0.0001
71840946|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-4.759||||0.7329|TWO_SIDED|95.0|-32.159|22.641|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||22.641|-32.159|0.7329
71840947|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-21.962||||0.542|TWO_SIDED|95.0|-62.989|19.065|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||19.065|-62.989|0.5420
71840948|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.591||||0.5234|TWO_SIDED|95.0|-77.049|23.866|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||23.866|-77.049|0.5234
71840949|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-20.761||||0.5975|TWO_SIDED|95.0|-61.867|20.344|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||20.344|-61.867|0.5975
71893548|NCT01309737|143308343|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71675128|NCT03018080|142867658|OTHER|Estimation only|Rate|0.191|||||TWO_SIDED|95.0|0.055|0.419|||||Confidence interval estimated using the Clopper Pearson method.|||0.419|0.055|
71675129|NCT03018080|142867658|OTHER|Estimation only.|Rate|0.421|||||TWO_SIDED|95.0|0.203|0.665|||||Confidence interval estimated using the Clopper Pearson method|||0.665|0.203|
71893549|NCT01309737|143308343|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71893550|NCT05662332|143308414|NON_INFERIORITY|Noninferiority margin (NIM) was 0.4%|LS Mean Change difference|-0.03|||||TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|
71893551|NCT05662332|143308415|SUPERIORITY||LS Mean Change difference|-0.03||||0.684|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.684
71675130|NCT03018080|142867659|OTHER|Estimation only|Median|4.1|||||TWO_SIDED|95.0|1.4|6.9|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.9|1.4|
71675131|NCT03018080|142867659|OTHER|Estimation only|Median|3.9|||||TWO_SIDED|95.0|1.4|6.8|||||The Kaplan Meier method was used to estimate the median PFS(in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||6.8|1.4|
71675132|NCT03018080|142867660|OTHER|Estimation only|Median|27.6|||||TWO_SIDED|95.0|9.7||Upper limit of the confidence interval is not reached due to censoring rate||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.||||9.7|
71800491|NCT04574362|143100834|SUPERIORITY||Risk difference|7.7|||<|0.0001|TWO_SIDED|95.0|4.4|11.0|||Cochran-Mantel-Haenszel|Within the family of key secondary endpoints, multiplicity was controlled using the Hochberg procedure.|Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||11.0|4.4|<0.0001
71800492|NCT04574362|143100835|SUPERIORITY||Risk difference|-0.7||||0.2057|TWO_SIDED|95.0|-1.9|0.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||0.4|-1.9|0.2057
71675133|NCT03018080|142867660|OTHER|Estimation only|Median|9.0|||||TWO_SIDED|95.0|6.8|14.0|||||The Kaplan Meier method was used to estimate median OS (in months). The Greenwood method was used to estimate confidence limits of median overall survival.|||14.0|6.8|
71675134|NCT03018080|142867661|OTHER|Estimation only.|Rate|0.667|||||TWO_SIDED|95.0|0.43|0.854|||||Confidence interval estimated using the Clopper Pearson method|||0.854|0.430|
71675135|NCT03018080|142867661|OTHER|Estimation only|Rate|0.632|||||TWO_SIDED|95.0|0.384|0.837|||||Confidence interval estimated using the Clopper Pearson method|||0.837|0.384|
71675136|NCT03018080|142867662|OTHER|Estimation only|Median|7.3|||||TWO_SIDED|95.0|5.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|5.6|
71675137|NCT03018080|142867662|OTHER|Estimation only|Median|4.0|||||TWO_SIDED|95.0|2.6|8.3|||||"The Kaplan Meier method was used to estimate median duration of response (in months).~The Greenwood method was used to estimate confidence limits of median duration of response."|||8.3|2.6|
71675138|NCT01050582|142867666|SUPERIORITY_OR_OTHER||Slope|0.447|STANDARD_ERROR_OF_MEAN|0.116|<|0.001|TWO_SIDED|95.0|0.22|0.674|||Regression, Linear|Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.||0.674|0.220|<0.001
71675139|NCT01050582|142867667|SUPERIORITY_OR_OTHER||Slope|-0.221|STANDARD_ERROR_OF_MEAN|0.25||0.378|TWO_SIDED|95.0|-0.711|0.269|||Regression, Linear|Covariates: Tanner stage and gender|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.|The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.||0.269|-0.711|0.378
71800493|NCT04574362|143100835|SUPERIORITY||Risk Difference (RD)|0.0||||0.9702|TWO_SIDED|95.0|-1.1|1.1||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||1.1|-1.1|0.9702
71800494|NCT04574362|143100835|SUPERIORITY||Risk Difference (RD)|1.0||||0.2419|TWO_SIDED|95.0|-0.7|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||2.8|-0.7|0.2419
71893552|NCT05662332|143308416|SUPERIORITY||LS Mean Change difference|4.16||||0.155|TWO_SIDED|95.0|-1.58|9.9|||ANCOVA|||Week 52||9.90|-1.58|0.155
71675140|NCT01050582|142867668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865|||>|0.999||95.0|0.189|3.963|||Fisher Exact||Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events||3.963|0.189|>0.999
71675141|NCT03935425|142867694|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71675142|NCT00885664|142867705|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71675143|NCT00885664|142867706|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71675144|NCT00885664|142867707|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71675145|NCT00885664|142867708|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71800495|NCT04574362|143100835|SUPERIORITY||Risk Difference (RD)|2.4||||0.0597|TWO_SIDED|95.0|-0.1|4.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||4.8|-0.1|0.0597
71675146|NCT00885664|142867709|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71675147|NCT00885664|142867710|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71675148|NCT00885664|142867711|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71675149|NCT00885664|142867712|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71675150|NCT00885664|142867713|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71675151|NCT00885664|142867714|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71675152|NCT00885664|142867715|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71675153|NCT01562782|142867729|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups in the primary outcome- the mean fold change in plasma VLDL triglyceride palmitate, 0-4 hours. A power calculation was based on data obtained in 15 overweight subjects. Assuming a mean absolute difference of 2.7 in South Asians and 1.0 in Caucasians and a standard deviation of 2.0 for both, group sample sizes of 16 and 16 were expected to achieve 80% power to detect a difference of 1.7 using a 2-sided Mann-Whitney test.|Mean Difference (Final Values)|0.61||||0.05|TWO_SIDED||||||Mixed Models Analysis|||The equivalence test was used to compare the fold change in plasma VLDL triglyceride palmitate in Caucasians and South Asians.||||0.05
71675154|NCT01562782|142867730|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test was used to compare 1) the fold change in triglycerides in South Asians and Caucasians and 2) the fold change in VLDL triglycerides in South Asians and Caucasians.||||<0.05
71675155|NCT01562782|142867731|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test is used to compare levels after the sugar beverage of 1) glucose at 1 hour 2) lactate at 1 hour 3) NEFA at 2 hours in South Asians vs Caucasians.||||<0.05
71675156|NCT01562782|142867732|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71675157|NCT01562782|142867733|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71893553|NCT05662332|143308417|SUPERIORITY||LS Mean Change difference|-43.7|||<|0.001|TWO_SIDED|95.0|-62.4|-25.0|||Mixed Models Analysis|||Week 52||-25.0|-62.4|<0.001
71893554|NCT05662332|143308418|SUPERIORITY||Relative Rate|0.57||||0.005|TWO_SIDED|95.0|0.39|0.84|||Negative binomial model|||||0.84|0.39|0.005
71840950|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.337||||0.9331|TWO_SIDED|95.0|-62.853|36.179|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||36.179|-62.853|0.9331
71840951|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-19.964||||0.2444|TWO_SIDED|95.0|-53.637|13.709|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||13.709|-53.637|0.2444
71675158|NCT01562782|142867734|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||Pearson or Spearman's rank test|||The equivalence test was used to analyze the relationship between the primary outcome, fold change in VLDL TG palmitate, and the listed levels of biomarkers of carbohydrate and fat metabolism. The correlation analysis was performed on data from each study group separately.||||<0.05
71675159|NCT01562782|142867735|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71675160|NCT01562782|142867736|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71800496|NCT04574362|143100835|SUPERIORITY||Risk Difference (RD)|5.2||||0.0012|TWO_SIDED|95.0|2.1|8.4||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||8.4|2.1|0.0012
71800497|NCT04574362|143100836|SUPERIORITY||Risk Difference (RD)|-0.7||||0.6809|TWO_SIDED|95.0|-3.9|2.5||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|15 minutes post-dose||2.5|-3.9|0.6809
71840952|NCT04800211|143191003|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-13.254||||0.5169|TWO_SIDED|95.0|-53.427|26.919|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||26.919|-53.427|0.5169
71893555|NCT05662332|143308420|SUPERIORITY||Relative Rate|0.58||||0.155|TWO_SIDED|95.0|0.28|1.23|||Negative binomial model|||||1.23|0.28|0.155
71893556|NCT05662332|143308422|SUPERIORITY||LS Mean difference (Final Values)|0.57||||0.033|TWO_SIDED|95.0|0.047|1.1|||Mixed Models Analysis|||||1.10|0.047|0.033
71675161|NCT01562782|142867737|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71675162|NCT01562782|142867738|EQUIVALENCE|A P value \<0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71675163|NCT00911612|142867741|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||Not adjusted since only one comparison was made.|ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for baseline geometric center at 24 hours , BMI, and 7 alpha CHO.||||0.22
71675164|NCT00911612|142867742|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for BMI and 7 alpha HCO.||||0.02
71675165|NCT02307279|142867782|SUPERIORITY||Mean Difference (Net)|-2.07|STANDARD_ERROR_OF_MEAN|0.59||0.0007|TWO_SIDED|95.0|-3.24|-0.9|||ANCOVA|Adjusted for stratification factors, and baseline weight|Difference in adjusted mean taken for comparability between the two groups (treatment - placebo)|Simple Superiority, H0: μ (Placebo) -μ (Gelesis100) = 0||-0.90|-3.24|0.0007
71675166|NCT02307279|142867782|SUPERIORITY|||||||0.1193|||||||ANCOVA|Adjusted for stratification factors, and baseline weight||Super-Superiority (\>3% difference), H0: μ(Placebo)-μ(Gelesis100) \< 3%||||0.1193
71675167|NCT02307279|142867783|SUPERIORITY|The performance goal for body weight responders was set at 35%.|||||<|0.0001|||||||Binomial Proportion Test|||H0: π (Gelesis100)\< 0.35||||<0.0001
71800498|NCT04574362|143100836|SUPERIORITY||Risk Difference (RD)|2.2||||0.2586|TWO_SIDED|95.0|-1.6|6.0||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|30 minutes post-dose||6.0|-1.6|0.2586
71800499|NCT04574362|143100836|SUPERIORITY||Risk Difference (RD)|4.5||||0.0421|TWO_SIDED|95.0|0.2|8.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|45 minutes post-dose||8.8|0.2|0.0421
71840953|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.174||||0.1359|TWO_SIDED|95.0|-93.12|12.772|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||12.772|-93.120|0.1359
71840954|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-71.725||||0.0129|TWO_SIDED|95.0|-127.961|-15.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.490|-127.961|0.0129
71840955|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.308||||0.3262|TWO_SIDED|95.0|-112.293|37.678|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||37.678|-112.293|0.3262
71840956|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-20.012||||0.4343|TWO_SIDED|95.0|-70.468|30.444|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.444|-70.468|0.4343
71893557|NCT05662332|143308423|SUPERIORITY||LS Mean difference (Final Values)|1.56||||0.071|TWO_SIDED|95.0|-0.13|3.25|||Mixed Models Analysis|||Week 52||3.25|-0.13|0.071
71893558|NCT05662332|143308426|SUPERIORITY||LS Mean difference (Final Values)|1.8||||0.072|TWO_SIDED|95.0|-0.2|3.8|||Mixed Models Analysis|||Week 52||3.8|-0.2|0.072
71893559|NCT01446809|143308433|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71800500|NCT04574362|143100836|SUPERIORITY||Risk Difference (RD)|6.6||||0.0066|TWO_SIDED|95.0|1.8|11.3||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|60 minutes post-dose||11.3|1.8|0.0066
71893560|NCT01446809|143308434|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71893561|NCT01212445|143308468|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.192||||0.179|TWO_SIDED|95.0|0.096|0.325|||Fisher Exact|||The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.325|0.096|0.1790
71800501|NCT04574362|143100836|SUPERIORITY||Risk Difference (RD)|9.9||||0.0002|TWO_SIDED|95.0|4.8|14.9||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|90 minutes post-dose||14.9|4.8|0.0002
71800502|NCT04574362|143100837|SUPERIORITY||Risk Difference (RD)|-10.4||||0.1148|TWO_SIDED|95.0|-23.5|2.8||Nominal p-value|Cochran-Mantel-Haenszel||Risk difference and associated 95% CI were calculated from Mantel-Haenszel test, stratified by use of prophylactic medication and country. The risk difference was tested at a two-sided alpha level of 0.05.|||2.8|-23.5|0.1148
71800503|NCT02002767|143100840|OTHER||Geometric Least Squares Mean(GLSM) Ratio|149.05|||||TWO_SIDED|90.0|116.62|190.49||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||190.49|116.62|
71800504|NCT02002767|143100841|OTHER||GLSM Ratio|149.9|||||TWO_SIDED|90.0|116.97|192.11||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||192.11|116.97|
71800505|NCT02002767|143100842|OTHER||GLSM Ratio|110.85|||||TWO_SIDED|90.0|90.76|135.38||||||A sample size of 8 evaluable participants in each renal function group (normal and severely impaired) will provide at least 80% power to reject the null hypothesis that participants with severe renal impairment have a minimum increase of 100% in AUC0-last, AUCinf, or Cmax of velpatasvir compared to participants with normal renal function.||135.38|90.76|
71800506|NCT00812929|143100847|SUPERIORITY||Mean Difference (Net)|1.29|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-1.56|4.13||||||||4.13|-1.56|
71800507|NCT00812929|143100847|SUPERIORITY||Mean Difference (Net)|0.53|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|95.0|-2.32|3.37||||||||3.37|-2.32|
71800508|NCT00812929|143100847|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|1.441|||TWO_SIDED|95.0|-2.52|3.18||||||||3.18|-2.52|
71800509|NCT00812929|143100847|SUPERIORITY||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|1.438|||TWO_SIDED|95.0|-0.31|5.37||||||||5.37|-0.31|
71800510|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.638|||TWO_SIDED|95.0|-0.72|5.75||||||2 Hours||5.75|-0.72|
71800511|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-2.34|2.58||||||9.5 Hours||2.58|-2.34|
71800512|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|2.6|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|-0.64|5.84||||||2 Hours||5.84|-0.64|
71800513|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|0.76|STANDARD_ERROR_OF_MEAN|1.247|||TWO_SIDED|95.0|-1.7|3.22||||||9.5 Hours||3.22|-1.70|
71800514|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|1.639|||TWO_SIDED|95.0|-0.45|6.03||||||2 Hours||6.03|-0.45|
71800515|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|3.49|STANDARD_ERROR_OF_MEAN|1.248|||TWO_SIDED|95.0|1.02|5.95||||||9.5 Hours||5.95|1.02|
71800516|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|1.637|||TWO_SIDED|95.0|3.06|9.54||||||2 Hours||9.54|3.06|
71800517|NCT00812929|143100848|SUPERIORITY||Mean Difference (Net)|2.27|STANDARD_ERROR_OF_MEAN|1.245|||TWO_SIDED|95.0|-0.19|4.73||||||9.5 Hours||4.73|-0.19|
71800518|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-1.37|3.25|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.25|-1.37|
71800519|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-1.66|1.8|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||1.80|-1.66|
71800520|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-0.82|2.63|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||2.63|-0.82|
71800521|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-1.19|3.43|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.43|-1.19|
71800522|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.878|||TWO_SIDED|95.0|-0.51|2.95|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||2.95|-0.51|
71800523|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.873|||TWO_SIDED|95.0|-1.55|1.9|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.90|-1.55|
71800524|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|1.51|STANDARD_ERROR_OF_MEAN|1.171|||TWO_SIDED|95.0|-0.8|3.82|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||3.82|-0.80|
71800525|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|0.879|||TWO_SIDED|95.0|1.57|5.03|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||5.03|1.57|
71800526|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.874|||TWO_SIDED|95.0|-1.83|1.62|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||1.62|-1.83|
71800527|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|3.17|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|0.86|5.48|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours||5.48|0.86|
71800528|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|0.877|||TWO_SIDED|95.0|0.38|3.84|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours||3.84|0.38|
71800529|NCT00812929|143100849|SUPERIORITY||Mean Difference (Net)|1.72|STANDARD_ERROR_OF_MEAN|0.872|||TWO_SIDED|95.0|0.0|3.44|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours||3.44|-0.00|
71800530|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.71|2.21|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.21|0.71|
71675168|NCT02307279|142867783|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0008|TWO_SIDED|95.0|1.34|3.01|||Regression, Logistic|Adjusted for stratification factors and baseline weight||"OR-trt refers to the odds ratio of being a body weight responder for Gelesis100 vs. Placebo.~H0: OR-trt= 1."||3.01|1.34|0.0008
71800531|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.59|2.06|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||2.06|0.59|
71800532|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.78|||||TWO_SIDED|95.0|0.93|3.43|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.43|0.93|
71800533|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.42|||||TWO_SIDED|95.0|0.81|2.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||2.48|0.81|
71800534|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.93|||||TWO_SIDED|95.0|1.01|3.66|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.66|1.01|
71800535|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.67|||||TWO_SIDED|95.0|0.86|3.25|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.25|0.86|
71840957|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.657||||0.0967|TWO_SIDED|95.0|-97.481|8.167|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||8.167|-97.481|0.0967
71845589|NCT04941482|143205827|SUPERIORITY||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.05|TWO_SIDED|95.0|-7.6|2.5||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Fatigue Severity Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|2.5|-7.6|<0.05
71800536|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|1.19|3.69|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||3.69|1.19|
71800537|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|5.49|||||TWO_SIDED|95.0|2.75|10.94|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||10.94|2.75|
71800538|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|1.0|3.64|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||3.64|1.00|
71800539|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|3.6|||||TWO_SIDED|95.0|2.0|6.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours||6.48|2.00|
71800540|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|2.03|||||TWO_SIDED|95.0|1.07|3.87|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours||3.87|1.07|
71800541|NCT00812929|143100850|SUPERIORITY||Hazard Ratio (HR)|6.07|||||TWO_SIDED|95.0|2.9|12.71|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours||12.71|2.90|
71800542|NCT00678691|143100905|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||all p-values come from one model analysis and are therefore included in free text as such|piecewise model|A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 - week 8||Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 - week 8).||||<0.05
71800543|NCT00128180|143100907|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||||||0.18
71800544|NCT03296163|143100917|EQUIVALENCE|"Equivalence analysis was based on the risk ratio (RR) (MB02/EU-approved Avastin) with an equivalence margin predefined \[0.73, 1.36\].~The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the RR and corresponding 2-sided 90% confidence interval (CI)."|Risk Ratio (RR)|0.91|||||TWO_SIDED|90.0|0.78|1.06|||||Direction of comparison is: For RR: MB02/EU-approved Avastin. 95% CI was also calculated: (0.758, 1.092)|||1.060|0.780|
71800545|NCT03296163|143100917|EQUIVALENCE|The ORR estimate was stratified using the Cochran-Mantel-Haenszel estimate of the risk difference (RD) (MB02-EU-approved Avastin) with an equivalence margin predefined \[-12%, 12%\] and corresponding 2-sided 95% CI.|Risk Difference (RD)|-4.02|||||TWO_SIDED|90.0|-10.51|2.47|||||Direction of comparison is: For RD: MB02 - EU-approved Avastin. 95% CI was also calculated: (-11.76, 3.71)|||2.47|-10.51|
71800546|NCT03296163|143100918|OTHER|Hazard ratio of MB02 versus EU-approved Avastin; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in MB02; \<1 indicated an increase in PD/death in EU-approved Avastin.|Hazard Ratio (HR)|1.187|||||TWO_SIDED|95.0|0.98|1.44||||||||1.44|0.98|
71800547|NCT03296163|143100919|OTHER||Hazard Ratio (HR)|1.108|||||TWO_SIDED|95.0|0.827|1.485||||||||1.485|0.827|
71800548|NCT00395044|143100927|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Mixed Models Analysis|||||||.029
71800549|NCT03282955|143100941|NON_INFERIORITY|Non-inferiority margin= 1.151||||||0.025|||||||t-test, 1 sided|||||||0.025
71800550|NCT04154631|143100973|SUPERIORITY||Time by treatment interaction coeff.|-10.91|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Immediate TranS-C (Standard/Adapted combined) versus UC-DT on change in sleep disturbance from pre to post.||||<0.001
71800551|NCT04154631|143100973|SUPERIORITY||Coefficient of indirect effect|0.17||||0.95|TWO_SIDED|95.0|-4.62|4.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||4.95|-4.62|0.95
71800552|NCT04154631|143100973|SUPERIORITY||Coefficient of indirect effect|0.09||||0.95|TWO_SIDED|95.0|-2.39|2.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.56|-2.39|0.95
71800553|NCT04154631|143100973|SUPERIORITY||Coefficient of indirect effect|-0.16||||0.88|TWO_SIDED|95.0|-2.31|1.98|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.98|-2.31|0.88
71800554|NCT04154631|143100973|SUPERIORITY||Coefficient of indirect effect|-0.13||||0.88|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.88
71800555|NCT04154631|143100973|SUPERIORITY||Coefficient of indirect effect|-0.5||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
71800556|NCT04154631|143100973|SUPERIORITY||Coefficient of indirect effect|-0.26||||0.79|TWO_SIDED|95.0|-2.18|1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep disturbance (PROMIS-SD) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.66|-2.18|0.79
71800557|NCT04154631|143100974|SUPERIORITY||time by treatment interaction coeff.|-0.03||||0.77|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Acceptability Intervention Measure (AIM) from baseline (post-training) to post-treatment.||||0.77
71800558|NCT04154631|143100975|SUPERIORITY||Time by treatment interaction coeff.|-9.52|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in sleep-related impairment from pre to post.||||<0.001
71800559|NCT04154631|143100975|SUPERIORITY||Coefficient of indirect effect|0.26||||0.92|TWO_SIDED|95.0|-5.04|5.56|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||5.56|-5.04|0.92
71800560|NCT04154631|143100975|SUPERIORITY||Coefficient of indirect effect|0.1||||0.92|TWO_SIDED|95.0|-2.04|2.24|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.24|-2.04|0.92
71800561|NCT04154631|143100975|SUPERIORITY||Coefficient of indirect effect|-0.39||||0.78|TWO_SIDED|95.0|-3.1|2.31|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||2.31|-3.10|0.78
71800562|NCT04154631|143100975|SUPERIORITY||Coefficient of indirect effect|-0.3||||0.78|TWO_SIDED|95.0|-2.35|1.75|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||1.75|-2.35|0.78
71800563|NCT04154631|143100975|SUPERIORITY||Coefficient of indirect effect|-0.43||||0.84|TWO_SIDED|95.0|-4.66|3.8|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||3.80|-4.66|0.84
71800564|NCT04154631|143100975|SUPERIORITY||Coefficient of indirect effect|-0.18||||0.84|TWO_SIDED|95.0|-1.94|1.58|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and sleep-related impairment (PROMIS-SRI) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.58|-1.94|0.84
71800565|NCT04154631|143100976|SUPERIORITY||Time by treatment interaction coeff.|1.63|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in Composite Sleep Health Score from pre to post.||||<0.001
71800566|NCT04154631|143100977|SUPERIORITY||Time by treatment interaction coeff.|-5.12|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in functional impairment from pre to post.||||<0.001
71800567|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|-3.12|||<|0.001|TWO_SIDED|95.0|-4.58|-1.66|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-1.66|-4.58|<0.001
71800568|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|-3.81|||<|0.001|TWO_SIDED|95.0|-5.41|-2.22|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and functional impairment (Sheehan Disability Scale) at post was mediated by sleep-related impairment (PROMIS-SRI). The parameter of interest was the indirect effect at post||-2.22|-5.41|<0.001
71800569|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|0.07||||0.94|TWO_SIDED|95.0|-1.78|1.92|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.92|-1.78|0.94
71800570|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|0.05||||0.94|TWO_SIDED|95.0|-1.16|1.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||1.25|-1.16|0.94
71800571|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|0.03||||0.85|TWO_SIDED|95.0|-0.3|0.37|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.37|-0.30|0.85
71800572|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|-0.23||||0.7|TWO_SIDED|95.0|-1.41|0.95|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.95|-1.41|0.70
71800573|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.23|0.92
71800574|NCT04154631|143100977|SUPERIORITY||Coefficient of indirect effect|-0.07||||0.82|TWO_SIDED|95.0|-0.68|0.54|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (Sheehan Disability Scale) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.54|-0.68|0.82
71800575|NCT04154631|143100978|SUPERIORITY||Time by treatment interaction coeff.|-6.72|||<|0.001|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment condition (Standard/Adapted TranS-C versus UC-DT) on change in psychiatric symptoms from pre to post.||||<0.001
71800576|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|-1.86||||0.08|TWO_SIDED|95.0|-3.93|-0.21|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep disturbance (PROMIS-SD) at post. The parameter of interest was the indirect effect.||-0.21|-3.93|0.08
71800577|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|-2.51||||0.02|TWO_SIDED|95.0|-4.58|-0.44|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between TranS-C condition (Immediate vs. UC-DT) and psychiatric symptoms (Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by sleep-related impairment (PROMIS-SRI) at post. The parameter of interest was the indirect effect.||-0.44|-4.58|0.02
71800578|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|0.05||||0.97|TWO_SIDED|95.0|-1.99|2.08|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||2.08|-1.99|0.97
71800579|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|0.004||||0.97|TWO_SIDED|95.0|-0.18|0.19|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of acceptability (AIM) at post. The parameter of interest was the indirect effect.||0.19|-0.18|0.97
71800580|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|0.02||||0.9|TWO_SIDED|95.0|-0.27|0.3|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.30|-0.27|0.90
71800581|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|0.01||||0.94|TWO_SIDED|95.0|-0.19|0.2|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of appropriateness (IAM) at post. The parameter of interest was the indirect effect.||0.20|-0.19|0.94
71800582|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|-0.19||||0.8|TWO_SIDED|95.0|-1.67|1.28|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at post was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||1.28|-1.67|0.80
71800583|NCT04154631|143100978|SUPERIORITY||Coefficient of indirect effect|-0.04||||0.77|TWO_SIDED|95.0|-0.33|0.25|||SEM|||Structural equation modeling (SEM) was used to test whether the relationship between treatment condition (Standard vs. Adapted) and functional impairment (The Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure) at 6-month follow-up was mediated by provider ratings of feasibility (FIM) at post. The parameter of interest was the indirect effect.||0.25|-0.33|0.77
71800584|NCT04154631|143100979|SUPERIORITY||time by treatment interaction coeff.|-0.01||||0.94|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Intervention Appropriateness Measure (IAM) from baseline (post-training) to post-treatment.||||0.94
71800585|NCT04154631|143100980|SUPERIORITY||Time by treatment interaction coeff.|-0.11||||0.34|TWO_SIDED||||||Intent-to-treat, multilevel modeling|||Treatment effect (Standard versus Adapted TranS-C) on change in Feasibility of Intervention Measure (FIM) from baseline (post-training) to post-treatment.||||0.34
71800586|NCT02550652|143101008|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|95.0|-3.4|28.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||28.1|-3.4|0.1145
71800587|NCT02550652|143101008|SUPERIORITY||Difference in Percentage of Participants|12.3||||0.1145|TWO_SIDED|80.0|2.1|22.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|Difference in Percentage of Participants||||22.6|2.1|0.1145
71800588|NCT02550652|143101009|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246||95.0|3.0|37.2||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||37.2|3.0|0.0246
71800589|NCT02550652|143101009|SUPERIORITY||Difference in Percentage of Participants|20.1||||0.0246|TWO_SIDED|80.0|8.9|31.3||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||31.3|8.9|0.0246
71840958|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.974||||0.4198|TWO_SIDED|95.0|-99.915|41.966|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||41.966|-99.915|0.4198
71840959|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-33.141||||0.2121|TWO_SIDED|95.0|-85.475|19.193|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||19.193|-85.475|0.2121
71800590|NCT02550652|143101010|SUPERIORITY|||||||0.0744|||||||Log Rank|||||||0.0744
71800591|NCT02550652|143101011|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015||95.0|4.7|38.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||38.7|4.7|0.0150
71800592|NCT02550652|143101011|SUPERIORITY||Difference in Percentage of Participants|21.7||||0.015|TWO_SIDED|80.0|10.6|32.8||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||32.8|10.6|0.0150
71800593|NCT02550652|143101012|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|95.0|-17.5|13.4||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||13.4|-17.5|0.8461
71800594|NCT02550652|143101012|SUPERIORITY||Difference in Percentage of Participants|-2.0||||0.8461|TWO_SIDED|80.0|-12.1|8.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||8.1|-12.1|0.8461
71800595|NCT02550652|143101013|SUPERIORITY|||||||0.353|||||||Log Rank|||||||0.3530
71800596|NCT02550652|143101014|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|95.0|-1.13|-0.491||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.491|-1.13|<0.0001
71800597|NCT02550652|143101014|SUPERIORITY||Difference in Adjusted Mean|-0.81|||<|0.0001|TWO_SIDED|80.0|-1.019|-0.602||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||-0.602|-1.019|<0.0001
71800598|NCT02550652|143101015|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|95.0|0.081|0.275||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.275|0.081|0.0004
71800599|NCT02550652|143101015|SUPERIORITY||Difference in Adjusted Mean|0.178||||0.0004|TWO_SIDED|80.0|0.115|0.241|||ANCOVA|||||0.241|0.115|0.0004
71800600|NCT02550652|143101016|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001||95.0|0.052|0.124|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).||||0.124|0.052|<0.0001
71800601|NCT02550652|143101016|SUPERIORITY||Difference in Adjusted Mean|0.088|||<|0.0001|TWO_SIDED|80.0|0.065|0.112||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|ANCOVA|||||0.112|0.065|<0.0001
71800602|NCT02550652|143101017|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09||95.0|-2.4|30.1||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||30.1|-2.4|0.0900
71800603|NCT02550652|143101017|SUPERIORITY||Difference in Percentage of Participants|13.9||||0.09|TWO_SIDED|80.0|3.2|24.5||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||24.5|3.2|0.0900
71800604|NCT02550652|143101018|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|95.0|-6.4|27.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||27.6|-6.4|0.1838
71800605|NCT02550652|143101018|SUPERIORITY||Difference in Percentage of Participants|10.6||||0.1838|TWO_SIDED|80.0|-0.5|21.7||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||21.7|-0.5|0.1838
71800606|NCT02550652|143101019|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|95.0|-10.0|24.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%."|Cochran-Mantel-Haenszel|||||24.6|-10.0|0.3726
71800607|NCT02550652|143101019|SUPERIORITY||Difference in Percentage of Participants|7.3||||0.3726|TWO_SIDED|80.0|-4.0|18.6||"Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).~Statistically significant at pre-specified alpha of 20%"|Cochran-Mantel-Haenszel|||||18.6|-4.0|0.3726
71800608|NCT01706250|143101030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.29|STANDARD_DEVIATION|32.98||0.6779|||||||t-test, 2 sided|||Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6779
71800609|NCT01706250|143101030|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.68|STANDARD_DEVIATION|29.51||0.2847|||||||t-test, 2 sided|||Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.2847
71800610|NCT01706250|143101030|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.24|STANDARD_DEVIATION|23.35||0.6894|||||||t-test, 2 sided|||Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8||||0.6894
71800611|NCT01706250|143101031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.38|STANDARD_DEVIATION|50.1||0.9909|||||||Signed Rank|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)||||0.9909
71800612|NCT01706250|143101031|SUPERIORITY_OR_OTHER||Median Difference (Net)|-4.0|STANDARD_DEVIATION|39.91||0.6671|||||||t-test, 2 sided|||IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)||||0.6671
71800613|NCT01706250|143101031|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.64|STANDARD_DEVIATION|52.05||0.0632|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)||||0.0632
71800614|NCT01706250|143101032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|42.31||0.7385|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)||||0.7385
71800615|NCT01706250|143101032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.04|STANDARD_DEVIATION|37.77||0.7296|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)||||0.7296
71800616|NCT01706250|143101032|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_DEVIATION|36.11||0.3774|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)||||0.3774
71800617|NCT01706250|143101033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.02|STANDARD_DEVIATION|29.53||0.7634|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)||||0.7634
71800618|NCT01706250|143101033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.75|STANDARD_DEVIATION|29.61||0.4087|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)||||0.4087
71800619|NCT01706250|143101033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0|STANDARD_DEVIATION|25.4||0.2455|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)||||0.2455
71800620|NCT01706250|143101034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.39||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
71800621|NCT01706250|143101034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.56||0.125|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.1250
71800622|NCT01706250|143101034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||0.625|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.6250
71800623|NCT01706250|143101034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||1.0000
71800624|NCT01706250|143101035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.45||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
71800625|NCT01706250|143101035|SUPERIORITY_OR_OTHER||Signed Rank|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
71800626|NCT01706250|143101036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.22||1|||||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.00
71800627|NCT01706250|143101036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.23||1|||||||Signed rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||1.0000
71800628|NCT01706250|143101037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_DEVIATION|0.46||1|||||||Signed rank|||Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||1.0000
71800629|NCT01706250|143101038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_DEVIATION|0.67||0.5313||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5313
71800630|NCT01706250|143101038|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.16|STANDARD_DEVIATION|0.6||0.5||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.5000
71675169|NCT02484456|142867790|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.79||0.68|TWO_SIDED||||||Mixed Models Analysis|||||||0.68
71675170|NCT02484456|142867791|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.72||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71800631|NCT01706250|143101038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.75|||||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.7500
71800632|NCT01706250|143101038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33|STANDARD_DEVIATION|0.84||0.25|||||||Signed rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
71800633|NCT01706250|143101039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|0.86||0.2131|||||||Signed Rank)|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.2131
71800634|NCT01706250|143101039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_DEVIATION|1.16||0.2656||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.2656
71800635|NCT01706250|143101039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.2344||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2344
71800636|NCT01706250|143101039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_DEVIATION|0.73||0.3594||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3594
71800637|NCT01706250|143101040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.32||0.6172|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.6172
71800638|NCT01706250|143101040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26|STANDARD_DEVIATION|0.93||0.3984|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.3984
71800639|NCT01706250|143101040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_DEVIATION|1.1||0.0781||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.0781
71800640|NCT01706250|143101040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39|STANDARD_DEVIATION|1.24||0.375||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.3750
71800641|NCT01706250|143101041|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|STANDARD_DEVIATION|0.46||1||95.0|||||[Signed Rank]|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||1.0000
71800642|NCT01706250|143101041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_DEVIATION|0.58||0.0625||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.0625
71800643|NCT01706250|143101041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.75||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.2500
71800644|NCT01706250|143101041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.38||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.2500
71800645|NCT01706250|143101042|SUPERIORITY_OR_OTHER||Signed Rank|0.15|STANDARD_DEVIATION|0.59||0.5||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)||||0.5000
71800646|NCT01706250|143101042|SUPERIORITY_OR_OTHER||Signed Rank|0.11|STANDARD_DEVIATION|0.57||0.75||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)||||0.7500
71800647|NCT01706250|143101042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.62||0.4531||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)||||0.4531
71800648|NCT01706250|143101042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_DEVIATION|0.86||0.625||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)||||0.6250
71800649|NCT03181542|143101047|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71800650|NCT03181542|143101048|SUPERIORITY|||||||0.4|||||||Jonckheere-Terpstra Test|||||||0.40
71800651|NCT03181542|143101049|SUPERIORITY|||||||0.9|||||||Jonckheere-Terpstra Test|||||||0.90
71800652|NCT00799617|143101059|SUPERIORITY||Mean Difference (Net)|0.58|||<|0.001|TWO_SIDED|95.0|0.38|0.78||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||0.78|0.38|<0.001
71893562|NCT01212445|143308468|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.314||||1|TWO_SIDED|95.0|0.191|0.459|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.459|0.191|1.0000
71675171|NCT02484456|142867792|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.89||0.71|TWO_SIDED||||||Mixed Models Analysis|||||||0.71
71675172|NCT02484456|142867793|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.06||0.25|TWO_SIDED||||||Mixed Models Analysis|||||||0.25
71675173|NCT02484456|142867794|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|1.27||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
71800653|NCT00799617|143101060|SUPERIORITY||Odds Ratio (OR)|1.42||||0.2|TWO_SIDED|95.0|0.83|2.45||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.||2.45|0.83|0.20
71800654|NCT00799617|143101061|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3|TWO_SIDED|95.0|0.83|1.84||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||1.84|0.83|0.30
71800655|NCT00799617|143101062|SUPERIORITY||Mean Difference (Final Values)|41.0||||0.003|TWO_SIDED|95.0|14.0|67.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||67|14|.003
71800656|NCT00799617|143101063|SUPERIORITY||Mean Difference (Final Values)|6.8|||<|0.001|TWO_SIDED|95.0|4.8|8.7||Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.|Regression, Linear|||||8.7|4.8|<.001
71800657|NCT00799617|143101064|SUPERIORITY||Mean Difference (Net)|-0.07||||0.88|TWO_SIDED|95.0|-0.92|0.79||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis|||"A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.~The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors."||0.79|-0.92|.88
71800658|NCT00799617|143101065|SUPERIORITY|Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.|Odds Ratio (OR)|31.5||||0.002|TWO_SIDED|95.0|3.7|277.8||The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.|Mixed Models Analysis|The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.||||277.8|3.7|.002
71840960|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|15.799||||0.5445|TWO_SIDED|95.0|-35.614|67.212|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||67.212|-35.614|0.5445
71840961|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.583||||0.9534|TWO_SIDED|95.0|-51.951|55.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||55.116|-51.951|0.9534
71845590|NCT04941482|143205828|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|95.0|-5.4|1.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Mini-Mental State Examinationscore before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|1.3|-5.4|<0.05
71800659|NCT00799617|143101066|SUPERIORITY||Mean Difference (Net)|2.93|||<|0.001|TWO_SIDED|95.0|2.13|3.74||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.74|2.13|<0.001
71800660|NCT00799617|143101067|SUPERIORITY||Median Difference (Net)|2.64|||<|0.001|TWO_SIDED|95.0|1.68|3.61||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors||||3.61|1.68|<0.001
71800661|NCT00799617|143101068|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.28|TWO_SIDED|95.0|-3.0|11.18||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||11.18|-3.00|0.28
71800662|NCT00799617|143101069|SUPERIORITY||Odds Ratio (OR)|1.34||||0.15|TWO_SIDED|95.0|0.9|2.0||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.00|0.90|0.15
71675174|NCT02484456|142867795|SUPERIORITY||Mean Difference (Final Values)|-1.83|STANDARD_ERROR_OF_MEAN|1.58||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
71675175|NCT02484456|142867796|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.02||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71800663|NCT00799617|143101070|SUPERIORITY||Mean Difference (Net)|2.75||||0.03|TWO_SIDED|95.0|0.2|5.29||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||5.29|0.20|0.03
71800664|NCT00799617|143101071|SUPERIORITY||Mean Difference (Net)|1.21||||0.06|TWO_SIDED|95.0|-0.04|2.46||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||2.46|-0.04|0.06
71800665|NCT00799617|143101072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.03|TWO_SIDED|95.0|0.31|4.5||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||4.50|0.31|0.03
71800666|NCT00799617|143101073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||||0.92|0.02|0.04
71800667|NCT00799617|143101074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.79|-0.19||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.19|-0.79|<0.001
71800668|NCT00799617|143101075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.004|TWO_SIDED|95.0|-1.2|-0.23||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect|||||-0.23|-1.20|0.004
71800669|NCT00799617|143101076|SUPERIORITY||Mean Difference (Final Values)|47.0||||0.006|TWO_SIDED|95.0|13.0|80.0||Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||80|13|.006
71675176|NCT02484456|142867797|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.34||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
71800670|NCT00799617|143101077|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.31|TWO_SIDED|95.0|-80.0|26.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.|||26|-80|.31
71800671|NCT00799617|143101078|SUPERIORITY||Mean Difference (Final Values)|2.9|||<|0.001|TWO_SIDED|95.0|2.1|3.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||3.7|2.1|<.001
71800672|NCT00799617|143101079|SUPERIORITY||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|3.2|5.3||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||5.3|3.2|<.001
71800673|NCT00799617|143101080|SUPERIORITY||Median Difference (Final Values)|1.5|||<|0.001|TWO_SIDED|95.0|0.9|2.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.0|0.9|<.001
71800674|NCT00799617|143101081|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.5||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.5|0.5|<.001
71800675|NCT00799617|143101082|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.8|1.7|||Regression, Linear|||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."||1.7|0.8|<.001
71893563|NCT01212445|143308468|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.196||||0.2558|TWO_SIDED|95.0|0.098|0.331|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.331|0.098|0.2558
71675177|NCT02484456|142867798|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|1.2||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71675178|NCT02484456|142867799|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.51||0.51|TWO_SIDED||||||Mixed Models Analysis|||||||0.51
71675179|NCT02484456|142867800|SUPERIORITY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.76||0.37|TWO_SIDED||||||Mixed Models Analysis|||||||0.37
71675180|NCT02484456|142867801|SUPERIORITY||Mean Difference (Final Values)|-2.02|STANDARD_ERROR_OF_MEAN|1.89||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
71675181|NCT02484456|142867802|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.92||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.60
71675182|NCT02484456|142867803|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.98||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71675183|NCT02484456|142867804|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.1||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||0.88
71675184|NCT02484456|142867805|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.91||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71675185|NCT02484456|142867806|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|1.3||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
71675186|NCT02484456|142867807|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_ERROR_OF_MEAN|1.26||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71675187|NCT02484456|142867808|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.98||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
71675188|NCT02484456|142867809|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.23||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
71675189|NCT02484456|142867810|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|1.39||0.81|TWO_SIDED||||||Mixed Models Analysis|||||||0.81
71675190|NCT02484456|142867811|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.31||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
71675191|NCT02484456|142867812|SUPERIORITY||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|1.89||0.35|TWO_SIDED||||||Mixed Models Analysis|||||||0.35
71675192|NCT02484456|142867813|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.63||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71800676|NCT00799617|143101083|SUPERIORITY||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.3|809.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||809|5.3|<.001
71675193|NCT02411396|142867864|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Mean Difference (Final Values)|124.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|118.3|130.9||||||This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.||130.9|118.3|
71675194|NCT02411396|142867865|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|5.14|||||TWO_SIDED|95.0|4.13|6.41|||||VOC in patients with SCD whom went to EDs represents the numerator, VOC in patients with SCD whom went to ICs represents the denominator for Odds Ratio.|||6.41|4.13|
71675195|NCT02411396|142867866|OTHER|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|2.24|||||TWO_SIDED|95.0|1.84|2.72|||||VOC in patients with SCD whom went to ICs represents the numerator, VOC in patients with SCD whom went to EDs represents the denominator for Odds Ratio.|||2.72|1.84|
71675196|NCT02064816|142867885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|3.5||0.277763|TWO_SIDED|95.0|-0.46|1.56|||Mann-Whitney Non Parametric test|||||1.56|-0.46|0.277763
71675197|NCT02064816|142867886|SUPERIORITY_OR_OTHER||Least Square (LS) Mean difference|1.3492||||0.0083|TWO_SIDED|95.0|0.3495|2.3489|||linear mixed model for repeated measures|||Week 4||2.3489|0.3495|0.0083
71675198|NCT02064816|142867886|SUPERIORITY_OR_OTHER||LS Mean difference|1.3367||||0.0079|TWO_SIDED|95.0|0.3534|2.32|||linear mixed model for repeated measures|||Week 8||2.3200|0.3534|0.0079
71675199|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.4003||||0.4311|TWO_SIDED|95.0|-0.5992|1.3998|||linear mixed model for repeated measures|||ISRs subscale Week 4||1.3998|-0.5992|0.4311
71675200|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.08479||||0.8635|TWO_SIDED|95.0|-0.885|1.0546|||linear mixed model for repeated measures|||ISRs subscale Week 8||1.0546|-0.8850|0.8635
71675201|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3245||||0.5099|TWO_SIDED|95.0|-1.2927|0.6437|||linear mixed model for repeated measures|||ISRs subscale Week 12||0.6437|-1.2927|0.5099
71675202|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.07079||||0.8574|TWO_SIDED|95.0|-0.8452|0.7036|||linear mixed model for repeated measures|||Global side-effect subscale: Week 4||0.7036|-0.8452|0.8574
71675203|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.1897||||0.6338|TWO_SIDED|95.0|-0.5926|0.972|||linear mixed model for repeated measures|||Global side-effect subscale: Week 8||0.9720|-0.5926|0.6338
71800677|NCT00799617|143101084|SUPERIORITY||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.0|10.9||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||10.9|6.0|<.001
71800678|NCT00799617|143101085|SUPERIORITY||Mean Difference (Final Values)|5.7|||<|0.001|TWO_SIDED|95.0|4.3|7.2||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||7.2|4.3|<.001
71800679|NCT00799617|143101086|SUPERIORITY||Mean Difference (Final Values)|1.8|||<|0.001|TWO_SIDED|95.0|1.1|2.6||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.6|1.1|<.001
71800680|NCT00799617|143101087|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.005|TWO_SIDED|95.0|0.3|1.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.7|0.3|.005
71800681|NCT00799617|143101088|SUPERIORITY||Mean Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|95.0|0.5|1.4||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.4|0.5|<.001
71840962|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|7.584||||0.8366|TWO_SIDED|95.0|-65.126|80.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||80.295|-65.126|0.8366
71800682|NCT00799617|143101089|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.01|TWO_SIDED|95.0|0.25|2.09||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||2.09|0.25|.01
71800683|NCT00799617|143101090|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.052|TWO_SIDED|95.0|-0.01|1.36||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.36|-0.01|.052
71800684|NCT00799617|143101091|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.27|TWO_SIDED|95.0|-0.45|1.58||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear|||||1.58|-0.45|0.27
71893564|NCT01212445|143308468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.774|4.763|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments."||4.763|0.774|
71800685|NCT00799617|143101092|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.24|TWO_SIDED|95.0|-0.76|0.19||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||0.19|-0.76|.24
71800686|NCT00799617|143101093|SUPERIORITY||Mean Difference (Net)|-0.12||||0.89|TWO_SIDED|95.0|-1.89|1.65||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.65|-1.89|.89
71800687|NCT00799617|143101094|SUPERIORITY||Mean Difference (Net)|-5.51||||0.14|TWO_SIDED|95.0|-12.91|1.88||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.||1.88|-12.91|.14
71800688|NCT00799617|143101095|SUPERIORITY||Mean Difference (Net)|0.83|||<|0.001|TWO_SIDED|95.0|0.48|1.39||The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.|Mixed Models Analysis||Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.|||1.39|0.48|<.001
71800689|NCT01848990|143101099|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.05||||0.4516|TWO_SIDED|95.0|-0.08|0.18|||ANOVA|Analysis of variance (ANOVA) with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 participants (Pt) being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.18|-0.08|0.4516
71675204|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.4097||||0.3042|TWO_SIDED|95.0|-0.3734|1.1929|||linear mixed model for repeated measures|||Global side-effect subscale: Week 12||1.1929|-0.3734|0.3042
71675205|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4083||||0.1038|TWO_SIDED|95.0|-0.9008|0.08419|||linear mixed model for repeated measures|||Benefits: Week 4||0.08419|-0.9008|0.1038
71893565|NCT01212445|143308468|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.024|||||TWO_SIDED|95.0|0.386|2.72|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||2.720|0.386|
71893566|NCT01212445|143308470|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.077||||0.235|TWO_SIDED|95.0|0.021|0.185|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.185|0.021|0.2350
71893567|NCT01212445|143308470|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.157||||0.5256|TWO_SIDED|95.0|0.07|0.286|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.286|0.070|0.5256
71675206|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.1358||||0.594|TWO_SIDED|95.0|-0.637|0.3653|||linear mixed model for repeated measures|||Benefits: Week 8||0.3653|-0.6370|0.5940
71675207|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.05809||||0.8217|TWO_SIDED|95.0|-0.5651|0.4489|||linear mixed model for repeated measures|||Benefits: Week 12||0.4489|-0.5651|0.8217
71675208|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.5909||||0.489|TWO_SIDED|95.0|-1.0873|2.269|||linear mixed model for repeated measures|||Description of pain: Week 4||2.2690|-1.0873|0.4890
71800690|NCT01848990|143101100|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.14||||0.0711|TWO_SIDED|95.0|-0.01|0.28|||ANOVA|ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 Pt being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide \>90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.||0.28|-0.01|0.0711
71675209|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.7689||||0.3719|TWO_SIDED|95.0|-2.4607|0.9229|||linear mixed model for repeated measures|||Description of pain: Week 8||0.9229|-2.4607|0.3719
71675210|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.1422||||0.869|TWO_SIDED|95.0|-1.5521|1.8364|||linear mixed model for repeated measures|||Description of pain: Week 12||1.8364|-1.5521|0.8690
71800691|NCT01848990|143101101|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.69||||0.0105|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0105
71800692|NCT01848990|143101101|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.79||||0.013|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0130
71800693|NCT01848990|143101101|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.78||||0.0511|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.0511
71800694|NCT01848990|143101101|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.34||||0.1176|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.1176
71800695|NCT01848990|143101102|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.81||||0.0456|TWO_SIDED|||||SMBG \<56 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.0456
71675211|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.6544||||0.8328|TWO_SIDED|95.0|-5.4393|6.7482|||linear mixed model for repeated measures|||VAS: Week 4||6.7482|-5.4393|0.8328
71675212|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-2.2294||||0.4764|TWO_SIDED|95.0|-8.38|3.9212|||linear mixed model for repeated measures|||VAS: Week 8||3.9212|-8.3800|0.4764
71675213|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-5.4196||||0.0852|TWO_SIDED|95.0|-11.5939|0.7547|||linear mixed model for repeated measures|||VAS: Week 12||0.7547|-11.5939|0.0852
71675214|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|0.006873||||0.9639|TWO_SIDED|95.0|-0.2918|0.3055|||linear mixed model for repeated measures|||Rating of pain: Week 4||0.3055|-0.2918|0.9639
71675215|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.08689||||0.5715|TWO_SIDED|95.0|-0.3886|0.2148|||linear mixed model for repeated measures|||Rating of pain: Week 8||0.2148|-0.3886|0.5715
71675216|NCT02064816|142867887|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2224||||0.1502|TWO_SIDED|95.0|-0.5256|0.0809|||linear mixed model for repeated measures|||Rating of pain: Week 12||0.08090|-0.5256|0.1502
71675217|NCT01732458|142867941|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-16.5|||||TWO_SIDED|95.0|-34.0|2.0||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||2.0|-34.0|
71675218|NCT01732458|142867941|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-4.4|||||TWO_SIDED|95.0|-22.9|14.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||14.3|-22.9|
71675219|NCT01732458|142867941|SUPERIORITY_OR_OTHER||Difference in Percentage vs. Ondansetron|-12.4|||||TWO_SIDED|95.0|-30.3|6.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.||6.3|-30.3|
71675220|NCT06047366|142867963|OTHER|||||||0.18||||||p \< 0.05 was used as the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.18
71675221|NCT06047366|142867964|OTHER|||||||0.09||||||p \< 0.05 was used as the threshold for statistical significance|Log Rank|||||||0.09
71675222|NCT03483961|142867970|SUPERIORITY|||||||0.0015||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 2 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0015
71675223|NCT03483961|142867970|SUPERIORITY|||||||0.0761||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 3 vs. Group 1.||Groups 2-8 are compared to Group 1||||0.0761
71675224|NCT03483961|142867970|SUPERIORITY|||||||0.9317||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 4 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.9317
71675225|NCT03483961|142867970|SUPERIORITY||||||<|0.0001||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 5 vs. Group 1.||Groups 2-8 are compared to Group 1.||||<.0001
71675226|NCT03483961|142867970|SUPERIORITY|||||||0.0045||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 6 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.0045
71675227|NCT03483961|142867970|SUPERIORITY|||||||0.1437||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 7 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.1437
71675228|NCT03483961|142867970|SUPERIORITY|||||||0.3216||||||All tests were carried out at a 2-sided significance level of 0.05 and no adjustment for multiplicity was applied, since the goal was to rank different formulations rather than to establish inferential values.|ANOVA|ANOVA model including site and treatment group as fixed effects assuming normality of log titers. P-value is for Group 8 vs. Group 1.||Groups 2-8 are compared to Group 1.||||0.3216
71675229|NCT02649439|142867977|SUPERIORITY|||||||0.4852|||||||Wilcoxon signed rank test|||||||0.4852
71675230|NCT02649439|142867978|SUPERIORITY|||||||0.3269|||||||Wilcoxon signed rank test|||||||0.3269
71800696|NCT01848990|143101102|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.92||||0.2322|TWO_SIDED|||||SMBG \<=70 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.2322
71675231|NCT02649439|142867981|SUPERIORITY|||||||0.0255||||||The reported p-value is representative of the PBMCs in monocyte nonclassical between responders and non-responders.|Mann Whitney Test|||||||0.0255
71675232|NCT02649439|142867981|OTHER|||||||0.0021||||||The reported p-value is representative of the PBMCs in monocyte nonclassical PD-L1+ between responders and non-responders.|Mann Whitney Test|||||||0.0021
71675233|NCT02649439|142867981|SUPERIORITY|||||||0.0486||||||The reported p-value is representative of the PBMCs in monocyte PD-1+ between responders and non-responders.|Mann Whitney Test|||||||0.0486
71800697|NCT01848990|143101102|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.87||||0.1365|TWO_SIDED|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII|||||0.1365
71675234|NCT02649439|142867982|SUPERIORITY|||||||0.7317||||||The reported p-value is representative of the PBMCs in CD4 between responders and non-responders.|Mann Whitney Test|||||||0.7317
71675235|NCT02649439|142867982|SUPERIORITY|||||||0.7545||||||The reported p-value is representative of the PBMCs in CD8 between responders and non-responders.|Mann Whitney Test|||||||0.7545
71675236|NCT02649439|142867982|SUPERIORITY|||||||0.531||||||The reported p-value is representative of the PBMCs in Treg between responders and non-responders.|Mann Whitney Test|||||||0.5310
71800698|NCT01848990|143101102|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.07||||0.8909|TWO_SIDED|||||Severe HEs|negative binomial model||Hylenex/Standard CSII|||||0.8909
71675237|NCT02649439|142867982|SUPERIORITY|||||||0.8451||||||The reported p-value is representative of the PBMCs in NK between responders and non-responders.|Mann Whitney Test|||||||0.8451
71675238|NCT02649439|142867982|SUPERIORITY|||||||0.9377||||||The reported p-value is representative of the PBMCs in MDSC between responders and non-responders.|Mann Whitney Test|||||||0.9377
71675239|NCT02649439|142867983|SUPERIORITY|||||||0.2012||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.2012
71675240|NCT02649439|142867983|SUPERIORITY|||||||0.4891||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4891
71675241|NCT02649439|142867983|SUPERIORITY|||||||0.4609||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.4609
71800699|NCT01848990|143101103|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.98||||0.7292|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7292
71800700|NCT01848990|143101103|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|0.95||||0.5895|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5895
71800701|NCT01848990|143101104|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.04||||0.5414|TWO_SIDED|||||SMBG \>240 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.5414
71800702|NCT01848990|143101104|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|rate ratio|1.03||||0.711|TWO_SIDED|||||SMBG \>300 mg/dL|negative binomial model||Hylenex/Standard CSII|||||0.7110
71800703|NCT01848990|143101105|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-3.4||||0.5394|TWO_SIDED|95.0|-14.2|7.5||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.5|-14.2|0.5394
71800704|NCT01848990|143101105|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|4.3||||0.4151|TWO_SIDED|95.0|-6.1|14.8||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.8|-6.1|0.4151
71800705|NCT01848990|143101105|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.993|TWO_SIDED|95.0|-9.5|9.6||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||9.6|-9.5|0.9930
71800706|NCT01848990|143101105|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.941|TWO_SIDED|95.0|-6.4|6.9||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-6.4|0.9410
71800707|NCT01848990|143101106|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-4.8||||0.3239|TWO_SIDED|95.0|-14.3|4.7||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-14.3|0.3239
71893568|NCT01212445|143308470|SUPERIORITY_OR_OTHER||Treatment Success Rate|0.118||||0.7746|TWO_SIDED|95.0|0.044|0.239|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher's).||0.239|0.044|0.7746
71675242|NCT02649439|142867983|SUPERIORITY|||||||0.0012||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0012
71675243|NCT02649439|142867983|SUPERIORITY|||||||0.0825||||||The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.0825
71800708|NCT01848990|143101106|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.754|TWO_SIDED|95.0|-7.4|10.2||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||10.2|-7.4|0.7540
71800709|NCT01848990|143101106|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.7904|TWO_SIDED|95.0|-9.5|7.2||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.2|-9.5|0.7904
71800710|NCT01848990|143101106|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.6||||0.4016|TWO_SIDED|95.0|-8.5|3.4||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||3.4|-8.5|0.4016
71800711|NCT01848990|143101107|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.4||||0.526|TWO_SIDED|95.0|-5.6|2.9|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.9|-5.6|0.5260
71800712|NCT01848990|143101108|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.5||||0.8049|TWO_SIDED|95.0|-3.7|4.7|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||4.7|-3.7|0.8049
71800713|NCT01848990|143101109|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8955||||||HbA1c \<7.0%|Chi-squared|||||||0.8955
71800714|NCT01848990|143101109|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%||||||0.8926||||||HbA1c ≤6.5%|Chi-squared|||||||0.8926
71800715|NCT01848990|143101110|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.13||||0.7735|TWO_SIDED|95.0|-0.76|1.03|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.03|-0.76|0.7735
71800716|NCT01848990|143101111|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.4948|TWO_SIDED|95.0|-4.1|2.0||Daily bolus dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.0|-4.1|0.4948
71800717|NCT01848990|143101111|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.3||||0.1099|TWO_SIDED|95.0|-0.5|5.2||Daily basal dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||5.2|-0.5|0.1099
71800718|NCT01848990|143101111|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.583|TWO_SIDED|95.0|-3.7|6.6||Daily total dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.6|-3.7|0.5830
71800719|NCT01848990|143101112|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.8778|TWO_SIDED|95.0|-1.0|1.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.1|-1.0|0.8778
71800720|NCT01848990|143101113|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.1||||0.3233|TWO_SIDED|95.0|-6.3|2.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.1|-6.3|0.3233
71800721|NCT01848990|143101115|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.0||||0.7708|TWO_SIDED|95.0|-5.8|7.8||Average glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7.8|-5.8|0.7708
71800722|NCT01848990|143101115|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.8||||0.6058|TWO_SIDED|95.0|-5.0|8.6||Median glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||8.6|-5.0|0.6058
71675244|NCT02649439|142867983|SUPERIORITY|||||||0.5988||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5988
71675245|NCT02649439|142867983|SUPERIORITY|||||||0.592|||||||Wilcoxon signed rank test|The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.||||||0.5920
71675246|NCT02649439|142867983|SUPERIORITY|||||||0.6221||||||The reported p-value is representative of the % of CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.6221
71675247|NCT02649439|142867983|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
71800723|NCT01848990|143101115|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.7||||0.6571|TWO_SIDED|95.0|-4.0|2.5||Average daily standard deviation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||2.5|-4.0|0.6571
71675248|NCT02649439|142867983|OTHER|||||||0.791||||||The reported p-value is representative of the % of Tregs in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7910
71675249|NCT02649439|142867983|SUPERIORITY|||||||0.5186||||||The reported p-value is representative of the % of NK in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.5186
71675250|NCT02649439|142867983|SUPERIORITY|The reported p-value is representative of the % of MDSC in PBMCs at Day 1 and Day 29.||||||0.5186|||||||Wilcoxon signed rank test|||||||0.5186
71675251|NCT02649439|142867983|SUPERIORITY|||||||0.9097||||||The reported p-value is representative of the % of naïve CD4 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.9097
71800724|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.2||||0.6252|TWO_SIDED|95.0|-11.3|6.9||Time per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||6.9|-11.3|0.6252
71800725|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-5.5||||0.5929|TWO_SIDED|95.0|-25.9|14.9||Time per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||14.9|-25.9|0.5929
71800726|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|6.9||||0.5207|TWO_SIDED|95.0|-14.4|28.3||Time per day \>70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||28.3|-14.4|0.5207
71800727|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-23.3||||0.4754|TWO_SIDED|95.0|-87.8|41.2||Time per day \<140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||41.2|-87.8|0.4754
71675252|NCT02649439|142867983|SUPERIORITY|||||||0.7334||||||The reported p-value is representative of the % of naïve CD8 in PBMCs at Day 1 and Day 29.|Wilcoxon signed rank test|||||||0.7334
71800728|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|23.9||||0.4644|TWO_SIDED|95.0|-40.7|88.6||Time per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||88.6|-40.7|0.4644
71800729|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Time per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
71800730|NCT01848990|143101116|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|18.4||||0.5151|TWO_SIDED|95.0|-37.5|74.4||Time per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||74.4|-37.5|0.5151
71800731|NCT01848990|143101117|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-33.5||||0.4216|TWO_SIDED|95.0|-115.9|48.9||Area per day \<56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||48.9|-115.9|0.4216
71800732|NCT01848990|143101117|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-84.7||||0.5697|TWO_SIDED|95.0|-379.2|209.8||Area per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||209.8|-379.2|0.5697
71800733|NCT01848990|143101117|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|342.9||||0.9241|TWO_SIDED|95.0|-6772.3|7458.2||Area per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||7458.2|-6772.3|0.9241
71800734|NCT01848990|143101117|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|TWO_SIDED|95.0|-54.2|59.8||Area per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||59.8|-54.2|0.9232
71800735|NCT01848990|143101117|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|Mean Difference (Final Values)|258.2||||0.9423|TWO_SIDED|95.0|-6792.2|7308.7||Area per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Least squares mean treatment difference (Hylenex minus Standard CSII)|||7308.7|-6792.2|0.9423
71800736|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5246|TWO_SIDED|95.0|-0.7|0.4||Leisure activities|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5246
71893569|NCT01212445|143308470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.233|||||TWO_SIDED|95.0|0.628|7.94|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||7.940|0.628|
71893570|NCT01212445|143308470|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.424|6.043|||Regression, Logistic|||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."||6.043|0.424|
71893571|NCT01212445|143308471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.752||||0.1876|TWO_SIDED|95.0|-3.834|19.338|||ANCOVA|||||19.338|-3.834|0.1876
71893572|NCT01212445|143308471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.706||||0.768|TWO_SIDED|95.0|-9.729|13.141|||ANCOVA|||||13.141|-9.729|0.7680
71800737|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.1||||0.638|TWO_SIDED|95.0|-0.8|0.5||Work life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.8|0.6380
71800738|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5719|TWO_SIDED|95.0|-0.7|0.4||Local or long distance travel|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.4|-0.7|0.5719
71800739|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.4052|TWO_SIDED|95.0|-0.8|0.3||Vacations|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.4052
71800740|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.724|TWO_SIDED|95.0|-0.4|0.6||Do physically|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.7240
71800741|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6876|TWO_SIDED|95.0|-0.4|0.6||Family life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6876
71800742|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6478|TWO_SIDED|95.0|-0.4|0.6||Friendships and social life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6478
71800743|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9744|TWO_SIDED|95.0|-0.6|0.6||Close personal relationship|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.6|0.9744
71800744|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3177|TWO_SIDED|95.0|-0.3|0.8||Sex life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.8|-0.3|0.3177
71800745|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.2087|TWO_SIDED|95.0|-0.2|0.7||Physical appearance|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.7|-0.2|0.2087
71800746|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.7907|TWO_SIDED|95.0|-0.4|0.5||Self-confidence|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.4|0.7907
71800747|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.3||||0.3444|TWO_SIDED|95.0|-0.8|0.3||Motivation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.8|0.3444
71800748|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.2175|TWO_SIDED|95.0|-0.1|0.6||The way people in general react|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.1|0.2175
71800749|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.4||||0.2062|TWO_SIDED|95.0|-1.0|0.2||Feelings about the future|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.0|0.2062
71800750|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.8762|TWO_SIDED|95.0|-0.5|0.6||Financial situation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.5|0.8762
71800751|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.89|TWO_SIDED|95.0|-0.5|0.5||Living situation and conditions|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.5|-0.5|0.8900
71800752|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.5||||0.1367|TWO_SIDED|95.0|-1.1|0.2||Depend on others|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.2|-1.1|0.1367
71800753|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3144|TWO_SIDED|95.0|-0.3|0.9||Freedom to eat|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.9|-0.3|0.3144
71800754|NCT01848990|143101118|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6869|TWO_SIDED|95.0|-0.4|0.6||Freedom to drink|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.6|-0.4|0.6869
71800755|NCT01848990|143101119|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9901|TWO_SIDED|95.0|-0.3|0.3|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||0.3|-0.3|0.9901
71800756|NCT01848990|143101120|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.9081|TWO_SIDED|95.0|-1.1|1.3||DTSQs|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.3|-1.1|0.9081
71800757|NCT01848990|143101120|NON_INFERIORITY|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.984|TWO_SIDED|95.0|-1.5|1.6||DTSQc|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII|||1.6|-1.5|0.9840
71800758|NCT00958880|143101126|SUPERIORITY_OR_OTHER||Slope|10.46||||0.015||95.0|||||Regression, Linear|||||||.015
71800759|NCT00958880|143101127|SUPERIORITY_OR_OTHER||Slope|0.03||||0.575||95.0|||||Regression, Linear|||||||.575
71800760|NCT02755831|143101133|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Fisher's Exact Test||||<0.05
71800761|NCT02755831|143101134|OTHER||||||<|0.05|||||||Friedman test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<.05
71800762|NCT02755831|143101135|OTHER||||||<|0.05|||||||Friedman|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.||||||<0.05
71800763|NCT02755831|143101136|OTHER||||||<|0.05|||||||Friedman Test|Friedman's test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences in treatment group only.||||||<0.05
71800764|NCT02755831|143101137|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|T-test used to compare mean difference in hospital costs at time of delivery.||||||<0.05
71800765|NCT01720069|143101138|SUPERIORITY|||||||0.772|||||||ANCOVA|||||||0.772
71800766|NCT01720069|143101139|SUPERIORITY|||||||0.891|||||||ANCOVA|||||||0.891
71800767|NCT01720069|143101140|SUPERIORITY|||||||0.066|||||||ANCOVA|||||||0.066
71800768|NCT01720069|143101141|SUPERIORITY|||||||0.063|||||||ANCOVA|||||||0.063
71893573|NCT01212445|143308471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.046||||0.2941|TWO_SIDED|95.0|-17.412|5.32|||ANCOVA|||||5.320|-17.412|0.2941
71800769|NCT01720069|143101142|SUPERIORITY|||||||0.054|||||||ANCOVA|||||||0.054
71800770|NCT01720069|143101143|SUPERIORITY|||||||0.168|||||||Fisher Exact|||||||0.168
71800771|NCT01720069|143101143|SUPERIORITY|||||||0.363|||||||Fisher Exact|||||||0.363
71800772|NCT01720069|143101143|SUPERIORITY|||||||0.805|||||||Fisher Exact|||||||0.805
71800773|NCT00508742|143101145|SUPERIORITY_OR_OTHER||Rate Ratio|0.56|||||TWO_SIDED|95.0|0.47|0.65||||||||0.65|0.47|
71800774|NCT00508742|143101146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.5|0.9||||||Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.9|0.5|
71800775|NCT00508742|143101146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.4|0.7||||||Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
71800776|NCT00508742|143101146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.3|0.5||||||Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.5|0.3|
71800777|NCT00508742|143101146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.7||||||Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.7|0.4|
71800778|NCT00508742|143101146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.4|0.8||||||Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.||0.8|0.4|
71800779|NCT00853658|143101232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1724|TWO_SIDED|95.0|0.85|1.03|||Regression, Cox|||(superiority)||1.03|0.85|0.1724
71800780|NCT00853658|143101232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4579|TWO_SIDED|95.0|0.85|1.07|||Regression, Cox|||(superiority) Non-Diabetic patients||1.07|0.85|0.4579
71800781|NCT00853658|143101232|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified Non-inferiority margin 1.104 is used.|Hazard Ratio (HR)|0.99||||0.0368|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||||1.10|0.90|0.0368
71800782|NCT00853658|143101232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9118|TWO_SIDED|95.0|0.9|1.1|||Regression, Cox|||(superiority)||1.10|0.90|0.9118
71800783|NCT06748040|143101241|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4852|TWO_SIDED|95.0|-2.4|1.2||P-value less than 0.05 is considered as statistically significant.|t-test, 2 sided|||||1.2|-2.4|0.4852
71800784|NCT02556710|143101242|SUPERIORITY|||||||0.94|||||||ANCOVA|Adjusted for baseline WOMAC Score||||||0.94
71800785|NCT02556710|143101243|SUPERIORITY|||||||0.53|||||||ANCOVA|Adjusted for baseline WOMAC score||||||0.53
71800786|NCT02556710|143101244|SUPERIORITY|||||||0.35||||||Adjusted for baseline WOMAC Score.|ANCOVA|||||||0.35
71893574|NCT01212445|143308472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.302||||0.8109|TWO_SIDED|95.0|-12.059|9.454|||ANCOVA|||||9.454|-12.059|0.8109
71893575|NCT01212445|143308472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.075||||0.6995|TWO_SIDED|95.0|-12.693|8.544|||ANCOVA|||||8.544|-12.693|0.6995
71800787|NCT01602315|143101280|SUPERIORITY_OR_OTHER_LEGACY||median HR|0.99||||||||||||||The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.||||
71800788|NCT01602315|143101280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.12||||0.643|TWO_SIDED|95.0|0.69|1.82|||Regression, Cox|||||1.82|0.69|0.643
71800789|NCT01602315|143101280|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.54||||0.039|TWO_SIDED|95.0|0.3|0.97|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from central data \[SLD (C)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||0.97|0.30|0.039
71800790|NCT01602315|143101283|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier method (median)|43.0|||||TWO_SIDED|95.0|27.0|88.0|||||days|||88.0|27.0|
71800791|NCT01602315|143101289|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.313|TWO_SIDED|95.0|0.79|2.05|||Regression, Cox|||||2.05|0.79|0.313
71800792|NCT01602315|143101290|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier (median)|294.0|||||TWO_SIDED|95.0|172.0|463.0||||||||463.0|172.0|
71800793|NCT01602315|143101304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.235|TWO_SIDED|95.0|0.49|1.19|||Regression, Cox|||||1.19|0.49|0.235
71800794|NCT01602315|143101304|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.64||||0.062|TWO_SIDED|95.0|0.4|1.02|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from local data \[SLD (L)\], Hemaglobin (Hgb) and White Blood Cells (WBC).||1.02|0.4|0.062
71800795|NCT01257204|143101354|SUPERIORITY_OR_OTHER||Difference|20.8|||||TWO_SIDED|80.0|4.9|36.8|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.8|4.9|
71893576|NCT01212445|143308472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772||||0.885|TWO_SIDED|95.0|-11.329|9.784|||ANCOVA|||||9.784|-11.329|0.8850
71893577|NCT01212445|143308473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.886||||0.0486|TWO_SIDED|95.0|0.078|25.695|||ANCOVA|||||25.695|0.078|0.0486
71675253|NCT00945035|142867984|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.02||||||90.0|0.97|1.07||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.07|0.97|
71893578|NCT01212445|143308473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.245||||0.8465|TWO_SIDED|95.0|-11.471|13.962|||ANCOVA|||||13.962|-11.471|0.8465
71893579|NCT01212445|143308473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.641||||0.0744|TWO_SIDED|95.0|-24.449|1.167|||ANCOVA|||||1.167|-24.449|0.0744
71893580|NCT01212445|143308474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.4591|TWO_SIDED|95.0|-6.153|13.534|||ANCOVA|||||13.534|-6.153|0.4591
71893581|NCT01212445|143308474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.887||||0.5546|TWO_SIDED|95.0|-6.765|12.539|||ANCOVA|||||12.539|-6.765|0.5546
71893582|NCT01212445|143308474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.803||||0.8685|TWO_SIDED|95.0|-10.397|8.79|||ANCOVA|||||8.790|-10.397|0.8685
71893583|NCT01212445|143308475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.311||||0.1865|TWO_SIDED|95.0|-0.774|0.152|||ANCOVA|||||0.152|-0.774|0.1865
71675254|NCT00945035|142867985|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \[GMR\] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.03||||||90.0|0.95|1.11||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction||1.11|0.95|
71893584|NCT01212445|143308475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.139||||0.553|TWO_SIDED|95.0|-0.602|0.323|||ANCOVA|||||0.323|-0.602|0.5530
71893585|NCT01212445|143308475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172||||0.467|TWO_SIDED|95.0|-0.293|0.637|||ANCOVA|||||0.637|-0.293|0.4670
71893586|NCT03972488|143308476|SUPERIORITY||Hazard Ratio (HR)|0.276|||<|0.0001|TWO_SIDED|95.0|0.182|0.418|||Log Rank|Stratified one-sided P-value||||0.418|0.182|<0.0001
71675255|NCT02016105|142868032|EQUIVALENCE|Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval \[-18%, 18%\].|Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|4.75|||TWO_SIDED|95.0|-7.46|11.15||||||||11.15|-7.46|
71893587|NCT03972488|143308477|SUPERIORITY||Stratified Odds Ratio|7.81|||<|0.0001|TWO_SIDED|95.0|3.32|18.4|||Stratified One-sided p-value|||||18.40|3.32|<0.0001
71800796|NCT01257204|143101354|SUPERIORITY_OR_OTHER||Difference|20.1|||||TWO_SIDED|80.0|3.9|36.3|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||36.3|3.9|
71800797|NCT01257204|143101363|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|80.0|-6.8|26.7|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||26.7|-6.8|
71893588|NCT03972488|143308478|SUPERIORITY||Hazard Ratio (HR)|0.856||||0.2222|TWO_SIDED|95.0|0.57|1.283|||Log Rank|Stratified one-sided P-value||Global Health Status||1.283|0.570|0.2222
71893589|NCT02799381|143308529|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-15.05|||<|0.0001|TWO_SIDED|95.0|-21.47|-8.63||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|||-8.63|-21.47|<0.0001
71800798|NCT01257204|143101363|SUPERIORITY_OR_OTHER||Difference|7.4|||||TWO_SIDED|80.0|-9.4|24.2|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.|||24.2|-9.4|
71800799|NCT01174030|143101393|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.392|||<|0.001||95.0|2.637|26.71|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||26.710|2.637|<0.001
71800800|NCT01174030|143101393|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.269||||0.549||95.0|0.586|2.747|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||2.747|0.586|0.549
71800801|NCT01174030|143101393|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.738||||0.027||95.0|1.097|12.742|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||12.742|1.097|0.027
71800802|NCT01174030|143101394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.683||||0.003||95.0|1.388|5.188|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model||||5.188|1.388|.003
71800803|NCT01174030|143101394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.892||||0.056||95.0|0.98|3.651|||GEE: Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.651|0.980|0.056
71800804|NCT01174030|143101394|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.885||||0.074||95.0|0.946|3.756|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.756|0.946|0.074
71800805|NCT01174030|143101395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.582|||<|0.001||95.0|2.755|15.723|||GEE: Logit link function|Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||15.723|2.755|<0.001
71800806|NCT01174030|143101395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.853||||0.093||95.0|0.903|3.802|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||3.802|0.903|0.093
71893590|NCT02799381|143308530|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|3.27|||<|0.0001|TWO_SIDED|95.0|1.71|4.83||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||4.83|1.71|<0.0001
71896320|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|8.873||||0.141|TWO_SIDED|95.0|0.484|162.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||162.775|0.484|0.141
71675256|NCT02016105|142868033|EQUIVALENCE|"LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.~Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval \[-15%; 15%\]."|LS means difference|0.8|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-3.15|4.84||||||||4.84|-3.15|
71675257|NCT02016105|142868034|EQUIVALENCE|LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval \[-15%; 15%\].|LS means difference|1.2|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-2.78|5.08||||||||5.08|-2.78|
71800807|NCT01174030|143101395|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.365||||0.054||95.0|0.96|5.825|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.||||5.825|0.960|0.054
71800808|NCT04086472|143101407|SUPERIORITY||Least squares (LS) Mean Difference|-1.31||||0.808|TWO_SIDED|90.0|-10.25|7.64|||ANOVA|||Treatment vs. Placebo||7.64|-10.25|0.808
71800809|NCT04086472|143101407|SUPERIORITY||LS Mean Difference|-6.51||||0.229|TWO_SIDED|90.0|-15.46|2.43|||ANOVA|||Treatment vs. Placebo||2.43|-15.46|0.229
71800810|NCT04086472|143101407|SUPERIORITY||LS Mean Difference|-4.81||||0.363|TWO_SIDED|90.0|-13.58|3.96|||ANOVA|||Treatment vs. Placebo||3.96|-13.58|0.363
71800811|NCT04086472|143101407|SUPERIORITY||LS Mean Difference|-5.92||||0.273|TWO_SIDED|90.0|-14.87|3.02|||ANOVA|||Treatment vs. Placebo||3.02|-14.87|0.273
71800812|NCT04086472|143101408|OTHER|Treatment vs. Placebo|Difference in percentage|0.51|||||TWO_SIDED|95.0|-36.57|37.78|||||95% CI based on the Chan and Zhang exact method|||37.78|-36.57|
71800813|NCT04086472|143101408|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|||15.53|-56.70|
71800814|NCT04086472|143101408|OTHER|Treatment vs. Placebo|Difference in percentage|-17.62|||||TWO_SIDED|95.0|-53.09|20.01|||||95% CI based on the Chan and Zhang exact method|||20.01|-53.09|
71800815|NCT04086472|143101408|OTHER|Treatment vs. Placebo|Difference in percentage|-22.56|||||TWO_SIDED|95.0|-56.7|15.53|||||95% CI based on the Chan and Zhang exact method|Treatment vs. Placebo||15.53|-56.70|
71800816|NCT00048724|143101413|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.452||||0.1439||95.0|0.88|2.396|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.396|0.880|0.1439
71800817|NCT00048724|143101414|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.564||||0.007||95.0|1.13|2.166|||Cox Proportional Hazards Model|Age (\<= 50 years, \>50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.||2.166|1.130|0.0070
71800818|NCT00844545|143101415|SUPERIORITY_OR_OTHER||LS mean change from baseline|65.18|||<|0.0001|TWO_SIDED|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols: C08-002A (adult) and C08-002B (adolescent), a similar protocol, for patients \<18 years with aHUS.||93.36|37.01|<0.0001
71896321|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|10.215||||0.126|TWO_SIDED|95.0|0.519|200.904||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||200.904|0.519|0.126
71800819|NCT00844545|143101416|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|82.0|||||TWO_SIDED|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||96|57|
71800820|NCT00844545|143101417|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
71800821|NCT00844545|143101418|SUPERIORITY_OR_OTHER||Percent of complete TMA response|65.0|||||TWO_SIDED|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||86|38|
71800822|NCT00844545|143101419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
71800823|NCT00844545|143101420|SUPERIORITY_OR_OTHER||LS mean change from baseline|111.62|||<|0.0001|TWO_SIDED|95.0|98.12|125.13|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||125.13|98.12|<0.0001
71800824|NCT00844545|143101421|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
71800825|NCT00844545|143101422|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|88.0|||||TWO_SIDED|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||99|64|
71800826|NCT00844545|143101423|SUPERIORITY_OR_OTHER||Percent of complete TMA response|76.0|||||TWO_SIDED|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||93|50|
71800827|NCT00844545|143101424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients \< 18 years of age for adolescent patients with aHUS.||||<0.0001
71800828|NCT02595684|143101442|SUPERIORITY|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
71800829|NCT02595684|143101442|SUPERIORITY|||||||0.635|||||||Wilcoxon (Mann-Whitney)|||||||0.635
71800830|NCT02595684|143101443|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.380
71800831|NCT02595684|143101443|SUPERIORITY|||||||0.441|||||||Wilcoxon (Mann-Whitney)|||||||0.441
71800832|NCT02595684|143101444|SUPERIORITY|||||||515|||||||Wilcoxon (Mann-Whitney)|||||||0515
71800833|NCT02595684|143101444|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
71800834|NCT02595684|143101445|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71800835|NCT02595684|143101445|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
71800836|NCT02595684|143101446|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
71800837|NCT02595684|143101446|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||||||0.779
71800838|NCT02595684|143101447|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
71800839|NCT02595684|143101447|SUPERIORITY|||||||0.767|||||||Wilcoxon (Mann-Whitney)|||||||0.767
71800840|NCT02595684|143101448|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
71800841|NCT02595684|143101448|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
71800842|NCT02595684|143101449|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
71800843|NCT02595684|143101449|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
71800844|NCT02595684|143101450|SUPERIORITY|||||||0.594|||||||Wilcoxon (Mann-Whitney)|||||||0.594
71800845|NCT02595684|143101450|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||||||0.086
71800846|NCT02595684|143101451|SUPERIORITY|||||||0.285|||||||Wilcoxon (Mann-Whitney)|||||||0.285
71800847|NCT02595684|143101451|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
71800848|NCT02595684|143101452|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
71800849|NCT02595684|143101452|SUPERIORITY|||||||0.263|||||||Wilcoxon (Mann-Whitney)|||||||0.263
71800850|NCT02595684|143101453|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
71800851|NCT02595684|143101453|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
71800852|NCT02595684|143101454|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||||||0.722
71800853|NCT02595684|143101454|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
71800854|NCT02595684|143101455|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
71800855|NCT02595684|143101455|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71800856|NCT02595684|143101456|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
71800857|NCT02595684|143101456|SUPERIORITY|||||||0.952|||||||Wilcoxon (Mann-Whitney)|||||||0.952
71800858|NCT02595684|143101457|SUPERIORITY|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||||||0.128
71800859|NCT02595684|143101457|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
71800860|NCT02595684|143101458|SUPERIORITY|||||||0.092|||||||Wilcoxon (Mann-Whitney)|||||||0.092
71800861|NCT02595684|143101458|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
71800862|NCT02809976|143101466|OTHER|single group/descriptive analysis||||||0.02|||||||paired t-test|||||||0.02
71800863|NCT04394351|143101483|SUPERIORITY||Odds Ratio (OR)|53.8|||<|0.0001|TWO_SIDED|95.0|7.37|392.82|||Cochran-Mantel-Haenszel|p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline weight group.|Odds ratio and corresponding Confidence Interval (CI) are based on CMH test stratified by baseline weight group.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||392.82|7.37|<0.0001
71800864|NCT04394351|143101483|SUPERIORITY||Odds Ratio (OR)|46.7|||<|0.0001|TWO_SIDED|95.0|5.47|399.54|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group.|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||399.54|5.47|<0.0001
71758495|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.58||||0.1078|TWO_SIDED|95.0|-0.13|1.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.29|-0.13|0.1078
71758496|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.62||||0.1487|TWO_SIDED|95.0|-0.22|1.47|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.47|-0.22|0.1487
71758497|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.33||||0.5537|TWO_SIDED|95.0|-0.77|1.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||1.43|-0.77|0.5537
71758498|NCT02420821|143019171|SUPERIORITY||LS Mean Difference|0.52||||0.5743|TWO_SIDED|95.0|-1.29|2.33|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.||2.33|-1.29|0.5743
71800865|NCT04394351|143101484|SUPERIORITY||Odds Ratio (OR)|178.0|||<|0.0001|TWO_SIDED|95.0|18.84|1682.4|||Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1682.4|18.84|<0.0001
71758499|NCT00999102|143019194|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.67|TWO_SIDED|95.0|-1.86|2.86|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 5 mg minus Mean Global Fatigue Score for Metoprolol 50 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||2.86|-1.86|0.67
71758500|NCT00999102|143019194|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.72|TWO_SIDED|95.0|-3.17|4.55|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 10 mg minus Mean Global Fatigue Score for Metoprolol 100 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||4.55|-3.17|0.72
71758501|NCT00999102|143019195|SUPERIORITY||Mean Difference (Final Values)|-7.03||||0.89|TWO_SIDED|95.0|-108.99|94.92|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 5 mg minus Mean Treadmill Exercise Time for Metoprolol 50 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).||94.92|-108.99|0.89
71758502|NCT00999102|143019195|SUPERIORITY||Mean Difference (Final Values)|-25.9||||0.43|TWO_SIDED|95.0|-91.55|39.75|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 10 mg minus Mean Treadmill Exercise Time for Metoprolol 100 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).||39.75|-91.55|0.43
71758503|NCT02839200|143019208|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
71758504|NCT02839200|143019208|OTHER||LS mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.95||0.241|TWO_SIDED|95.0|-18.7|4.7|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||4.7|-18.7|0.241
71758505|NCT02839200|143019208|OTHER||LS Mean difference|-10.8|STANDARD_ERROR_OF_MEAN|6.0||0.072|TWO_SIDED|95.0|-22.6|1.0|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||1|-22.6|0.072
71758506|NCT02839200|143019208|OTHER||LS Mean difference|-16.2|STANDARD_ERROR_OF_MEAN|5.95||0.007|TWO_SIDED|95.0|-27.9|-4.5|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-4.5|-27.9|0.007
71675258|NCT01908829|142868055|SUPERIORITY||Least Squares (LS) Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.47|-0.05||P values for pairwise comparisons were from the stratified rank ANCOVA model. P \< 0.05 indicated superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.05|-0.47|=0.001
71800866|NCT04394351|143101484|SUPERIORITY||Odds Ratio (OR)|55.3|||<|0.0001|TWO_SIDED|95.0|7.45|410.23||P-value is not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|p-value was derived by CMH test stratified by baseline weight group|Odds ratio and corresponding CI are based on CMH test stratified by baseline weight group|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||410.23|7.45|<0.0001
71800867|NCT04394351|143101485|SUPERIORITY||LS mean difference|-107.07|||<|0.0001|TWO_SIDED|95.0|-139.249|-74.9|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-74.900|-139.249|<0.0001
71800868|NCT04394351|143101485|SUPERIORITY||LS mean difference|-98.92|||<|0.0001|TWO_SIDED|95.0|-132.463|-65.37||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-65.370|-132.463|<0.0001
71800869|NCT04394351|143101486|SUPERIORITY||LS mean difference|-0.902|||<|0.0001|TWO_SIDED|95.0|-1.0325|-0.7714|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7714|-1.0325|<0.0001
71800870|NCT04394351|143101486|SUPERIORITY||LS mean difference|-0.78|||<|0.0001|TWO_SIDED|95.0|-0.917|-0.644||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6440|-0.9170|<0.0001
71800871|NCT04394351|143101487|SUPERIORITY||LS mean difference|-0.883|||<|0.0001|TWO_SIDED|95.0|-1.0095|-0.7568|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-0.7568|-1.0095|<0.0001
71800872|NCT04394351|143101487|SUPERIORITY||LS mean difference|-0.769|||<|0.0001|TWO_SIDED|95.0|-0.9013|-0.6362||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-0.6362|-0.9013|<0.0001
71800873|NCT04394351|143101488|SUPERIORITY||Hodges-Lehmann estimator|-2.22|||<|0.0001|TWO_SIDED|95.0|-2.44|-1.95|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9500|-2.4400|<0.0001
71800874|NCT04394351|143101488|SUPERIORITY||Hodges-Lehmann estimator|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.82||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.8200|-2.4500|<0.0001
71800875|NCT04394351|143101489|SUPERIORITY||Hodges-Lehmann estimator|-2.84|||<|0.0001|TWO_SIDED|95.0|-3.35|-1.96|||Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-1.9600|-3.3500|<0.0001
71800876|NCT04394351|143101489|SUPERIORITY||Hodges-Lehmann estimator|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.31|-1.62||P-value is not adjusted for multiple comparisons|Wilcoxon rank-sum test||Median Difference is Dupilumab minus Placebo|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-1.6200|-3.3100|<0.0001
71800877|NCT04394351|143101490|SUPERIORITY||LS mean difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.94|-2.63|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||-2.63|-4.94|<0.0001
71800878|NCT04394351|143101490|SUPERIORITY||LS mean difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.59|-2.1||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||-2.10|-4.59|<0.0001
71800879|NCT04394351|143101491|SUPERIORITY||LS mean difference|-0.1||||0.1526|TWO_SIDED|95.0|-0.244|0.038|||ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.038|-0.244|0.1526
71800880|NCT04394351|143101491|SUPERIORITY||LS mean difference|0.0||||0.9533|TWO_SIDED|95.0|-0.155|0.146||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.146|-0.155|0.9533
71800881|NCT04394351|143101492|SUPERIORITY||LS mean difference|1.45||||0.1507|TWO_SIDED|95.0|-0.527|3.422||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||3.422|-0.527|0.1507
71758507|NCT02839200|143019208|OTHER||LS Mean difference|-25.6|STANDARD_ERROR_OF_MEAN|5.92|<|0.001|TWO_SIDED|95.0|-37.3|-13.9|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||-13.9|-37.3|< 0.001
71758508|NCT02839200|143019208|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|5.97||0.155|TWO_SIDED|95.0|-20.4|3.3|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean|||3.3|-20.4|0.155
71758509|NCT01094119|143019220|SUPERIORITY|||||||0.0069|||||||Regression, Logistic|||||||0.0069
71758510|NCT02205736|143019221|SUPERIORITY|||||||0.8084||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 1 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.8084
71758511|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 2 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71758512|NCT02205736|143019221|SUPERIORITY|||||||0.0036||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 3 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0036
71758513|NCT02205736|143019221|SUPERIORITY|||||||0.0033||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 4 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||0.0033
71758514|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 5 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71758515|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 6 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71758516|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 7 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71758517|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 8 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71758518|NCT02205736|143019221|SUPERIORITY||||||<|0.0001||||||Each of the 25 co-primary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 9 at Baseline and Post-Intervention; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the Post-Intervention questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the Post-Intervention questionnaire.||||<.0001
71800882|NCT04394351|143101492|SUPERIORITY||LS mean difference|0.0||||0.9965|TWO_SIDED|95.0|-2.107|2.117||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||2.117|-2.107|0.9965
71800883|NCT04394351|143101493|SUPERIORITY||LS mean difference|-0.05||||0.2064|TWO_SIDED|95.0|-0.139|0.03||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.030|-0.139|0.2064
71800884|NCT04394351|143101493|SUPERIORITY||LS mean difference|0.02||||0.6361|TWO_SIDED|95.0|-0.069|0.112||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.112|-0.069|0.6361
71800885|NCT04394351|143101494|SUPERIORITY||LS mean difference|0.13||||0.2086|TWO_SIDED|95.0|-0.072|0.33||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.330|-0.072|0.2086
71800886|NCT04394351|143101494|SUPERIORITY||LS mean difference|0.1||||0.2975|TWO_SIDED|95.0|-0.088|0.286||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.286|-0.088|0.2975
71800887|NCT04394351|143101495|SUPERIORITY||LS mean difference|-1.8||||0.2085|TWO_SIDED|95.0|-4.615|1.007||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||1.007|-4.615|0.2085
71800888|NCT04394351|143101495|SUPERIORITY||LS mean difference|-1.36||||0.3098|TWO_SIDED|95.0|-3.972|1.26||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||1.260|-3.972|0.3098
71800889|NCT04394351|143101496|SUPERIORITY||LS mean difference|0.07||||0.236|TWO_SIDED|95.0|-0.046|0.186||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab High Dose versus Part A: Pooled Placebo||0.186|-0.046|0.2360
71800890|NCT04394351|143101496|SUPERIORITY||LS mean difference|0.07||||0.1939|TWO_SIDED|95.0|-0.037|0.181||P-value is not adjusted for multiple comparisons|ANCOVA||CI was based on treatment difference (Dupilumab group vs. placebo) of the LS mean change using ANCOVA model with baseline measurement as covariate and the treatment, baseline weight group strata as fixed factors.|Part A: Dupilumab Low Dose versus Part A: Pooled Placebo||0.181|-0.037|0.1939
71800891|NCT00812812|143101601|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.198|TWO_SIDED|95.0|-11.7|2.5|||ANCOVA||Mean difference was estimated as paroxetine minus placebo.|||2.5|-11.7|0.198
71800892|NCT03091751|143101606|OTHER||Mean Difference (Final Values)|10.41||||0.77|TWO_SIDED|95.0|-224.88|245.7|||t-test, 1 sided|||||245.70|-224.88|0.77
71800893|NCT03091751|143101607|OTHER||Mean Difference (Final Values)|0.3068||||0.002|TWO_SIDED|95.0|0.1501|0.4635|||t-test, 1 sided|||||0.4635|0.1501|0.002
71800894|NCT03091751|143101608|OTHER||Mean Difference (Final Values)|-3.3||||0.3|TWO_SIDED|95.0|-8.9|2.3|||t-test, 1 sided|||||2.3|-8.9|0.30
71800895|NCT03091751|143101609|OTHER||Mean Difference (Final Values)|-0.0058||||0.16|TWO_SIDED|95.0|-0.0119|0.0003|||t-test, 1 sided|||||0.0003|-0.0119|0.16
71800896|NCT03091751|143101610|OTHER||Mean Difference (Final Values)|-7.609||||0.02|TWO_SIDED|95.0|-13.344|-1.879|||t-test, 1 sided|||||-1.879|-13.344|0.02
71800897|NCT01161329|143101611|NON_INFERIORITY_OR_EQUIVALENCE|It was estimated that 128 individuals would be required for 80 % Power with a type I error of 5% to detect a 2-point difference in BBS with a standard deviation of +/- 4 points. Because of the slow recruitment and the statistically significant improvements observed in the primary outcome in the intervention group during an interim analysis the study was finalized with fewer participants than had been initially calculated.||||||0.001||||||The Bonferroni method was used to assess longitudinal Changes and correct for multiple comparisons, with significance set at p\<0.016 to minimize the risk for type I errors.|Wilcoxon (Mann-Whitney)|||Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.||||0.001
71800898|NCT01161329|143101612|SUPERIORITY_OR_OTHER|||||||0.09||||||The p-value for the man differnece in SPPB between grpoups att three months was 0.09|Wilcoxon (Mann-Whitney)|||||||0.09
71800899|NCT03402243|143101632|SUPERIORITY||Estimated mean ratio|1.38|||||TWO_SIDED|95.0|1.1|1.75|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a total menthol ban smoked relative to those randomized to a menthol cigarette ban|||1.75|1.1|
71800900|NCT03402243|143101632|SUPERIORITY||Estimated mean ratio|0.87|||||TWO_SIDED|95.0|0.68|1.11|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol cigarettes ban relative to those randomized to no menthol ban|||1.11|0.68|
71800901|NCT03402243|143101632|SUPERIORITY||Estimated mean ratio|1.2|||||TWO_SIDED|95.0|0.99|1.45|||||Baseline adjusted model estimated mean ratio in cigarettes smoked per day of those randomized to a menthol ban for cigarettes and e-cigarettes relative to those randomized to no menthol ban|||1.45|0.99|
71840963|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-55.973||||0.5437|TWO_SIDED|95.0|-154.862|42.916|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||42.916|-154.862|0.5437
71840964|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-73.308||||0.2974|TWO_SIDED|95.0|-177.224|30.608|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||30.608|-177.224|0.2974
71840965|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-44.892||||0.9026|TWO_SIDED|95.0|-181.909|92.126|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||92.126|-181.909|0.9026
71840966|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-35.811||||0.8954|TWO_SIDED|95.0|-132.513|60.891|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||60.891|-132.513|0.8954
71896322|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|13.717||||0.082|TWO_SIDED|95.0|0.715|263.125||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||263.125|0.715|0.082
71800902|NCT03402243|143101632|SUPERIORITY|||||||0.349|||||||Kruskal-Wallis|||Average number of puffs per participants over the 6 week study period||||0.349
71800903|NCT03402243|143101633|SUPERIORITY|||||||0.185|||||||Mixed Models Analysis|||Comparison among groups in number of cigarette packs selected||||0.185
71800904|NCT03402243|143101633|SUPERIORITY|||||||0.076|||||||Mixed Models Analysis|||Comparison among groups in number of e-cigarette liquid units selected||||0.076
71800905|NCT03402243|143101634|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
71800906|NCT00684424|143101637|SUPERIORITY_OR_OTHER_LEGACY||R-ratio|-56.723|STANDARD_DEVIATION|46.9499||||95.0|||||summary statistic|||R-ratio of seizure frequency summaries = \[(t-b)/(t+b)\]\*100; where t= treatment seizure frequency and b= baseline seizure frequency.||||
71800907|NCT00727857|143101653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|||<|0.0001||95.0|0.51|1.22|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||1.22|0.51|<0.0001
71800908|NCT00727857|143101653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|||<|0.0001||95.0|0.5|1.18|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.18|0.50|<0.0001
71675259|NCT01908829|142868056|SUPERIORITY||LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.14||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.14|-0.52|<0.001
71800909|NCT00727857|143101653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.8919||95.0|-0.37|0.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.33|-0.37|0.8919
71800910|NCT00727857|143101654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8||||0.0005||95.0|7.8|27.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||27.7|7.8|0.0005
71800911|NCT00727857|143101654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.0021||95.0|5.5|24.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||24.7|5.5|0.0021
71800912|NCT00727857|143101654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.5981||95.0|-12.5|7.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.2|-12.5|0.5981
71800913|NCT00727857|143101655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.5074||95.0|-1.43|2.88|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.88|-1.43|0.5074
71800914|NCT00727857|143101655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.93||||0.0047||95.0|0.9|4.95|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.95|0.90|0.0047
71800915|NCT00727857|143101655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.0435||95.0|0.06|4.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.33|0.06|0.0435
71800916|NCT00727857|143101656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.629||||0.3158||95.0|-0.602|1.861|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.861|-0.602|0.3158
71800917|NCT00727857|143101656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.619||||0.0067||95.0|0.452|2.785|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.785|0.452|0.0067
71800918|NCT00727857|143101656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.989||||0.1094||95.0|-0.223|2.201|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.201|-0.223|0.1094
71800919|NCT00727857|143101657|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.88||||0.5963||95.0|-4.71|13.97|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||13.97|-4.71|0.5963
71800920|NCT00727857|143101657|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|12.81||||0.0265||95.0|2.88|22.24|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||22.24|2.88|0.0265
71800921|NCT00727857|143101657|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|8.33||||0.1053||95.0|-1.77|18.07|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.||18.07|-1.77|0.1053
71800922|NCT00727857|143101658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.0806||95.0|-0.2|3.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.1|-0.2|0.0806
71800923|NCT00727857|143101658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-9.6|-6.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-6.5|-9.6|<0.0001
71800924|NCT00727857|143101658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.5|||<|0.0001||95.0|-11.1|-7.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-7.9|-11.1|<0.0001
71800925|NCT00727857|143101659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.73||||0.0324||95.0|0.31|7.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||7.14|0.31|0.0324
71800926|NCT00727857|143101659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78||||0.0233||95.0|-7.05|-0.52|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.52|-7.05|0.0233
71893591|NCT02799381|143308531|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-16.66|||<|0.0001|TWO_SIDED|95.0|-24.48|-8.85||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-8.85|-24.48|<0.0001
71800927|NCT00727857|143101659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.0001||95.0|-10.9|-4.12|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-10.90|<0.0001
71800928|NCT00727857|143101660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.0993||95.0|-0.93|10.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.72|-0.93|0.0993
71800929|NCT00727857|143101660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.56||||0.367||95.0|-8.14|3.01|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.01|-8.14|0.3670
71800930|NCT00727857|143101660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.46||||0.0119||95.0|-13.26|-1.66|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-1.66|-13.26|0.0119
71800931|NCT00727857|143101661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31||||0.0423||95.0|-8.48|-0.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.15|-8.48|0.0423
71800932|NCT00727857|143101661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-12.08|-4.12|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-4.12|-12.08|<0.0001
71800933|NCT00727857|143101661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.79||||0.728||95.0|-7.93|0.35|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.35|-7.93|0.728
71800934|NCT00727857|143101662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.9231||95.0|-7.94|8.76|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.76|-7.94|0.9231
71800935|NCT00727857|143101662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16||||0.3082||95.0|-3.86|12.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.19|-3.86|0.3082
71800936|NCT00727857|143101662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75||||0.3753||95.0|-4.56|12.07|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||12.07|-4.56|0.3753
71800937|NCT00727857|143101663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4||||0.4999||95.0|-44.6|91.4|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||91.4|-44.6|0.4999
71800938|NCT00727857|143101663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.2||||0.0531||95.0|-0.9|129.3|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||129.3|-0.9|0.0531
71800939|NCT00727857|143101663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.9||||0.2369||95.0|-26.9|108.7|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||108.7|-26.9|0.2369
71800940|NCT00727857|143101664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.5023||95.0|-0.09|0.19|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.19|-0.09|0.5023
71800941|NCT00727857|143101664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||<|0.0001||95.0|-0.48|-0.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.21|-0.48|<0.0001
71800942|NCT00727857|143101664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.0001||95.0|-0.53|-0.25|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.25|-0.53|<0.0001
71800943|NCT00727857|143101665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7||||0.2849||95.0|-16.5|55.9|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||55.9|-16.5|0.2849
71800944|NCT00727857|143101665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.6|||<|0.0001||95.0|-112.4|-42.8|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-42.8|-112.4|<0.0001
71800945|NCT00727857|143101665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-97.3|||<|0.0001||95.0|-133.4|-61.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-61.2|-133.4|<0.0001
71840967|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-46.239||||0.7485|TWO_SIDED|95.0|-146.766|54.288|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||54.288|-146.766|0.7485
71840968|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-36.559||||0.9578|TWO_SIDED|95.0|-169.77|96.653|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||96.653|-169.770|0.9578
71840969|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.725||||0.3635|TWO_SIDED|95.0|-129.208|47.757|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||47.757|-129.208|0.3635
71893592|NCT02799381|143308532|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.11|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.44|-2.78|<0.0001
71800946|NCT00727857|143101666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.2894||95.0|-4.5|15.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.1|-4.5|0.2894
71800947|NCT00727857|143101666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8463||95.0|-10.3|8.5|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||8.5|-10.3|0.8463
71800948|NCT00727857|143101666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.2||||0.2124||95.0|-16.0|3.6|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||3.6|-16.0|0.2124
71800949|NCT00727857|143101667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.804||95.0|-19.4|15.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||15.0|-19.4|0.8040
71800950|NCT00727857|143101667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.5||||0.0008||95.0|12.0|45.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||45.0|12.0|0.0008
71800951|NCT00727857|143101667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.6||||0.0005||95.0|13.4|47.8|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||47.8|13.4|0.0005
71800952|NCT00727857|143101668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.9604||95.0|-83.3|79.2|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||79.2|-83.3|0.9604
71675260|NCT01908829|142868056|SUPERIORITY||LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.18||P values for pairwise comparisons are from the stratified rank ANCOVA model. P \< 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.18|-0.60|<0.001
71675261|NCT01908829|142868056|SUPERIORITY||LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.11|=|0.001|TWO_SIDED|95.0|-0.46|-0.03||P-values for pairwise comparisons are from the stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (\< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.||-0.03|-0.46|=0.001
71675262|NCT01908829|142868057|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.01|TWO_SIDED|95.0|-0.47|-0.06||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.06|-0.47|=0.010
71675263|NCT01908829|142868057|SUPERIORITY||LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.19||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.65|<0.001
71675264|NCT01908829|142868057|SUPERIORITY||LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.23||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.23|-0.70|<0.001
71675265|NCT01908829|142868057|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.22||P-values for pairwise comparisons are from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.67|<0.001
71675266|NCT01908829|142868058|SUPERIORITY||Rate Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.05|=|0.005|TWO_SIDED|95.0|0.79|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.79|=0.005
71675267|NCT01908829|142868058|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.66|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.86|0.66|<0.001
71675268|NCT01908829|142868058|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.021|TWO_SIDED|95.0|0.7|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.97|0.70|=0.021
71675269|NCT01908829|142868058|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.014|TWO_SIDED|95.0|0.71|0.96||p\<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination \& solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate \& log of number of valid diary days as the offset variable.||0.96|0.71|=0.014
71840970|NCT04800211|143191004|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-8.333||||0.8713|TWO_SIDED|95.0|-110.097|93.431|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||93.431|-110.097|0.8713
71675270|NCT01908829|142868059|SUPERIORITY||LS Means|3.86|STANDARD_ERROR_OF_MEAN|2.19|<|0.078|TWO_SIDED|95.0|-0.43|8.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||8.16|-0.43|<0.078
71800953|NCT00727857|143101668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.3||||0.0004||95.0|62.5|218.0|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||218.0|62.5|0.0004
71800954|NCT00727857|143101668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|142.3||||0.0006||95.0|61.3|223.3|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||223.3|61.3|0.0006
71840971|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-115.256||||0.0003|TWO_SIDED|95.0|-177.973|-52.539|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-52.539|-177.973|0.0003
71840972|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-74.904||||0.0467|TWO_SIDED|95.0|-148.706|-1.102|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-1.102|-148.706|0.0467
71893593|NCT02799381|143308533|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-5.54|||=|0.0006|TWO_SIDED|95.0|-8.59|-2.49||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-2.49|-8.59|=0.0006
71675271|NCT01908829|142868059|SUPERIORITY||LS Means|11.19|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|5.98|16.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.40|5.98|<0.001
71800955|NCT00727857|143101669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.9922||95.0|-64.4|65.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||65.1|-64.4|0.9922
71800956|NCT00727857|143101669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.7||||0.0004||95.0|49.7|173.7|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||173.7|49.7|0.0004
71800957|NCT00727857|143101669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|111.4||||0.0008||95.0|46.8|175.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||175.9|46.8|0.0008
71675272|NCT01908829|142868059|SUPERIORITY||LS Means|12.38|STANDARD_ERROR_OF_MEAN|2.92|<|0.001|TWO_SIDED|95.0|6.65|18.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||18.12|6.65|<0.001
71800958|NCT00727857|143101670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0072||95.0|-1.86|-0.29|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.29|-1.86|0.0072
71800959|NCT00727857|143101670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.3682||95.0|-0.41|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.41|0.3682
71800960|NCT00727857|143101670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.42||||0.0004||95.0|0.64|2.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.20|0.64|0.0004
71800961|NCT00727857|143101671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.1986||95.0|-0.02|0.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.10|-0.02|0.1986
71800962|NCT00727857|143101671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1487||95.0|-0.1|0.02|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-0.10|0.1487
71800963|NCT00727857|143101671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.0076||95.0|-0.14|-0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.02|-0.14|0.0076
71800964|NCT00727857|143101672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.2384||95.0|-0.21|0.83|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.83|-0.21|0.2384
71800965|NCT00727857|143101672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4617||95.0|-0.69|0.31|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.31|-0.69|0.4617
71800966|NCT00727857|143101672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0593||95.0|-1.02|0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.02|-1.02|0.0593
71800967|NCT00727857|143101673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.5044||95.0|-0.54|1.1|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.10|-0.54|0.5044
71800968|NCT00727857|143101673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.0004||95.0|-2.22|-0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.64|-2.22|0.0004
71800969|NCT00727857|143101673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|||<|0.0001||95.0|-2.53|-0.89|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.89|-2.53|<0.0001
71800970|NCT00727857|143101674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0017||95.0|-2.64|-0.62|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-0.62|-2.64|0.0017
71800971|NCT00727857|143101674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||<|0.0001||95.0|1.01|2.94|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||2.94|1.01|<0.0001
71800972|NCT00727857|143101674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|||<|0.0001||95.0|2.59|4.61|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.61|2.59|<0.0001
71800973|NCT00727857|143101675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.76||||0.2466||95.0|-2.61|10.14|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||10.14|-2.61|0.2466
71800974|NCT00727857|143101675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.52||||0.0063||95.0|-14.63|-2.42|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.42|-14.63|0.0063
71800975|NCT00727857|143101675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.29||||0.0002||95.0|-18.65|-5.93|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.93|-18.65|0.0002
71800976|NCT00727857|143101676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.2069||95.0|-2.93|0.64|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.64|-2.93|0.2069
71800977|NCT00727857|143101676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.0052||95.0|0.73|4.15|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||4.15|0.73|0.0052
71800978|NCT00727857|143101676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.59|||<|0.0001||95.0|1.81|5.36|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.36|1.81|<0.0001
71800979|NCT00727857|143101677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.609||95.0|-1.28|0.75|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.75|-1.28|0.6090
71800980|NCT00727857|143101677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6169||95.0|-1.22|0.72|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.72|-1.22|0.6169
71800981|NCT00727857|143101677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.974||95.0|-0.99|1.03|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.03|-0.99|0.9740
71800982|NCT00727857|143101678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.615||95.0|-3.09|5.21|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||5.21|-3.09|0.6150
71840973|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-144.035|||<|0.0001|TWO_SIDED|95.0|-206.668|-81.402|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-81.402|-206.668|<.0001
71896323|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|28.283||||0.024|TWO_SIDED|95.0|1.561|512.532||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||512.532|1.561|0.024
71800983|NCT00727857|143101678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.2346||95.0|-6.38|1.57|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||1.57|-6.38|0.2346
71800984|NCT00727857|143101678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47||||0.1001||95.0|-7.61|0.67|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||0.67|-7.61|0.1001
71800985|NCT00727857|143101679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86||||0.1217||95.0|-0.76|6.48|||ANCOVA||Mean Difference = Pioglitazone \& metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||6.48|-0.76|0.1217
71800986|NCT00727857|143101679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.0009||95.0|-9.36|-2.44|||ANCOVA||Mean Difference = Pioglitazone \& metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-2.44|-9.36|0.0009
71800987|NCT00727857|143101679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.76|||<|0.0001||95.0|-12.36|-5.16|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.||-5.16|-12.36|<0.0001
71800988|NCT01196871|143101764|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.942|||||TWO_SIDED|90.0|2.439|3.548|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% confidence interval (CI) are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.548|2.439|
71800989|NCT01196871|143101764|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.942|||||TWO_SIDED|90.0|2.431|3.56|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.560|2.431|
71800990|NCT01196871|143101764|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|2.354|||||TWO_SIDED|90.0|1.826|3.035|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.035|1.826|
71675273|NCT01908829|142868059|SUPERIORITY||LS Means|11.52|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|6.06|16.99||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||16.99|6.06|<0.001
71675274|NCT01908829|142868060|SUPERIORITY||LS Means|-0.44|STANDARD_ERROR_OF_MEAN|0.15|=|0.003|TWO_SIDED|95.0|-0.73|-0.16||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.16|-0.73|=0.003
71800991|NCT01196871|143101764|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|2.375|||||TWO_SIDED|90.0|1.839|3.068|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||3.068|1.839|
71800992|NCT01196871|143101765|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.629|||||TWO_SIDED|90.0|1.44|1.843|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.843|1.440|
71800993|NCT01196871|143101765|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.546|||||TWO_SIDED|90.0|1.3|1.838|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.838|1.300|
71800994|NCT01196871|143101767|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.025|||||TWO_SIDED|90.0|0.921|1.14|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.140|0.921|
71800995|NCT01196871|143101767|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects mode Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.256|||||TWO_SIDED|90.0|1.026|1.538|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.538|1.026|
71800996|NCT01196871|143101769|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.034|||||TWO_SIDED|90.0|0.929|1.152|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.152|0.929|
71800997|NCT01196871|143101769|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|1.063|||||TWO_SIDED|90.0|0.972|1.164|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.164|0.972|
71800998|NCT01196871|143101771|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUC0-t Ratio|1.059|||||TWO_SIDED|90.0|0.818|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.818|
71800999|NCT01196871|143101771|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|AUCinfinity Ratio|1.052|||||TWO_SIDED|90.0|0.807|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.371|0.807|
71801000|NCT01196871|143101772|OTHER|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß\*Treatment + Error.|Cmax Ratio|0.997|||||TWO_SIDED|90.0|0.791|1.259|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.||1.259|0.791|
71801001|NCT03062891|143101781|SUPERIORITY||Slope|0.54||||0.572|TWO_SIDED|95.0|-1.33|2.4|||Regression, Linear|||This analysis looked at the interaction between baseline anxiety symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.40|-1.33|.572
71801002|NCT03062891|143101782|SUPERIORITY||Slope|0.08||||0.934|TWO_SIDED|95.0|-1.82|1.98|||Regression, Linear|||This analysis looked at the interaction between baseline depression symptoms and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.98|-1.82|.934
71801003|NCT03062891|143101783|SUPERIORITY||Slope|1.07||||0.253|TWO_SIDED|95.0|-0.76|2.89|||Regression, Linear|||This analysis looked at the interaction between attentional problems and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.89|-0.76|.253
71801004|NCT03062891|143101784|SUPERIORITY||Slope|1.2||||0.215|TWO_SIDED|95.0|-0.7|3.1|||Regression, Linear|||This analysis looked at the interaction between baseline paranois and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.10|-0.70|.215
71801005|NCT03062891|143101784|SUPERIORITY||Slope|1.14||||0.254|TWO_SIDED|95.0|-0.83|3.11|||Regression, Linear|||This analysis looked at the interaction between baseline hallucinations and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.11|-0.83|.254
71801006|NCT03062891|143101784|SUPERIORITY||Slope|-0.27||||0.778|TWO_SIDED|95.0|-2.13|1.59|||Regression, Linear|||This analysis looked at the interaction between baseline cognitive disorganization and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.59|-2.13|.778
71801007|NCT03062891|143101785|SUPERIORITY||Slope|-0.25||||0.8|TWO_SIDED|95.0|-2.16|1.67|||Regression, Linear|||This analysis looked at the interaction between baseline positive mental health and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||1.67|-2.16|.800
71801008|NCT03062891|143101786|SUPERIORITY||Slope|0.59||||0.525|TWO_SIDED|95.0|-1.25|2.44|||Regression, Linear|||This analysis looked at the interaction between baseline perceived stress and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||2.44|-1.25|.525
71801009|NCT03062891|143101787|SUPERIORITY||Slope|1.3||||0.14|TWO_SIDED|95.0|-0.43|3.03|||Regression, Linear|||This analysis looked at the interaction between baseline threatening life events and group on the change in insomnia symptoms across the intervention. The results of the interaction are reported here.||3.03|-0.43|.140
71801010|NCT03062891|143101788|SUPERIORITY||Slope|-2.58||||0.03|TWO_SIDED|95.0|-4.9|-0.25|||Generalized estimating equation|||This analysis looked at the effect of group on changes in anxiety symptoms across the intervention period.||-0.25|-4.90|.030
71801011|NCT03062891|143101789|SUPERIORITY||Slope|-0.63||||0.456|TWO_SIDED|95.0|-2.24|1.01|||Generalized estimating equation|||This analysis looked at the effect of group on changes in depression symptoms across the intervention period.||1.01|-2.24|.456
71801012|NCT03062891|143101790|SUPERIORITY||Slope|-2.34||||0.11|TWO_SIDED|95.0|-5.21|0.53|||Generalized estimating equation|||This analysis looked at the effect of group on changes attentional problems across the intervention period.||0.53|-5.21|.110
71801013|NCT03062891|143101791|SUPERIORITY||Slope|-1.69||||0.041|TWO_SIDED|95.0|-3.31|-0.07|||Generalized estimating equations|||This analysis looked at the effect of group on changes in psychotic experiences (paranoia) across the intervention period.||-0.07|-3.31|.041
71801014|NCT03062891|143101791|SUPERIORITY||Slope|-0.22||||0.531|TWO_SIDED|95.0|-0.92|0.48|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (hallucinations) across the intervention period.||0.48|-0.92|.531
71801015|NCT03062891|143101791|SUPERIORITY||Slope|-0.37||||0.13|TWO_SIDED|95.0|-0.84|0.11|||Generalized estimating equation|||This analysis looked at the effect of group on changes in psychotic experiences (cognitive disorganization) across the intervention period.||0.11|-0.84|.130
71801016|NCT03062891|143101792|SUPERIORITY||Slope|0.07||||0.916|TWO_SIDED|95.0|-1.17|1.3|||Generalized estimating equation|||This analysis looked at the effect of group on changes in positive mental health across the intervention period.||1.30|-1.17|.916
71801017|NCT03062891|143101793|SUPERIORITY||Slope|-2.03||||0.027|TWO_SIDED|95.0|-3.83|-0.23|||Generalized estimating equation|||This analysis looked at the effect of group on changes in perceived stress across the intervention period.||-0.23|-3.83|.027
71801018|NCT03062891|143101795|SUPERIORITY||Odds Ratio (OR)|1.36||||0.296|TWO_SIDED|95.0|0.77|2.4|||Regression, Logistic|||Assocation between baseline anxiety symptoms and exploding head syndrome||2.40|0.77|.296
71801019|NCT03062891|143101795|SUPERIORITY||Odds Ratio (OR)|0.69||||0.065|TWO_SIDED|95.0|0.47|1.02|||Regression, Logistic|||Assocation between baseline insomnia symptoms and exploding head syndrome||1.02|0.47|.065
71801020|NCT03062891|143101795|SUPERIORITY||Odds Ratio (OR)|0.67||||0.145|TWO_SIDED|95.0|0.39|1.15|||Regression, Logistic|||Assocation between baseline depression symptoms and exploding head syndrome||1.15|0.39|.145
71801021|NCT03062891|143101795|SUPERIORITY||Odds Ratio (OR)|1.26||||0.398|TWO_SIDED|95.0|0.73|2.19|||Regression, Logistic|||Assocation between baseline life stress and exploding head syndrome||2.19|0.73|.398
71801022|NCT03062891|143101795|SUPERIORITY||Odds Ratio (OR)|1.72||||0.001|TWO_SIDED|95.0|1.24|2.38|||Regression, Logistic|||Assocation between sleep paralysis and exploding head syndrome||2.38|1.24|.001
71801023|NCT02127307|143101796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.446|||<|0.0001|TWO_SIDED|95.0|0.3227|0.6156||At 0.025 level of significance.|Cox proportional hazards model|||"AdreView-Heart Failure Group with H/M \<1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time t was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.6156|0.3227|<0.0001
71893594|NCT02799381|143308534|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-2.35|||=|0.0002|TWO_SIDED|95.0|-3.51|-1.19||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||-1.19|-3.51|=0.0002
71893595|NCT02799381|143308535|SUPERIORITY|The likelihood-based mixed-effects model repeated measures (MMRM) analysis of the change from baseline to Week 12 used all observed data. The model included fixed, categorical effects for treatment, country, visit, and treatment-by-visit interaction, with continuous fixed covariates for baseline score and the baseline score-by-visit interaction.|LS Mean Difference|-4.05|||=|0.0762|TWO_SIDED|95.0|-8.55|0.44||Two-sided p-value|Mixed-effects model repeated measures||Levodopa-Carbidopa Intestinal Gel (LCIG) - Optimized Medical Treatment (OMT) at Week 12|If the primary efficacy variable was statistically significant, each of the secondary variables were to be tested using a fixed sequence as a gatekeeping procedure and at α level of 0.050. Testing was to cease at the point that a secondary variable failed to demonstrate statistical significance.||0.44|-8.55|=0.0762
71893596|NCT03952130|143308538|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07|||||TWO_SIDED|95.0|-0.11|0.24||||||||0.24|-0.11|
71893597|NCT03952130|143308539|SUPERIORITY||LS Mean Difference|-17.8||||0.003|TWO_SIDED|95.0|-29.4|-6.1|||ANCOVA|||||-6.1|-29.4|0.003
71893598|NCT03952130|143308540|SUPERIORITY||LS Mean Difference|-25.5||||0.001|TWO_SIDED|95.0|-41.1|-10.0|||ANCOVA|||||-10.0|-41.1|0.001
71801024|NCT03509948|143101797|SUPERIORITY||Geometric Least Squares Mean|79.57|||||TWO_SIDED|90.0|66.4|95.35||||||Fed/Fasted Ratio||95.35|66.40|
71801025|NCT03509948|143101798|SUPERIORITY||Geometric Least Squares Mean|92.08|||||TWO_SIDED|90.0|88.37|95.95||||||Fed/Fasted Ratio||95.95|88.37|
71801026|NCT03509948|143101799|SUPERIORITY||Geometric Least Squares Mean|90.89|||||TWO_SIDED|90.0|84.99|97.2||||||Fed/Fasted Ratio||97.20|84.99|
71801027|NCT03509948|143101801|SUPERIORITY||Geometric Least Squares Mean|1.0|||||TWO_SIDED|90.0|0.25|1.75||||||Fed/Fasted Ratio||1.75|0.25|
71801028|NCT03509948|143101803|SUPERIORITY||Geometric Least Squares Mean|91.4|||||TWO_SIDED|90.0|87.55|95.41||||||Fed/Fasted Ratio||95.41|87.55|
71801029|NCT01129141|143101806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.198|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|95.0|-22.86|-11.53|||Mixed Models Analysis|||||-11.53|-22.86|<.0001
71893599|NCT03952130|143308541|OTHER||Relative rate|0.85||||0.834|TWO_SIDED|95.0|0.19|3.77|||Empirical method|||||3.77|0.19|0.834
71893600|NCT03952130|143308542|OTHER||Relative rate|1.0||||0.983|TWO_SIDED|95.0|0.72|1.38|||Negative binomial regression|||\<=30 minutes post meal||1.38|0.72|0.983
71893601|NCT03952130|143308542|OTHER||Relative rate|1.61||||0.076|TWO_SIDED|95.0|0.95|2.74|||Negative binomial regression|||\<=1 hour post meal||2.74|0.95|0.076
71801030|NCT01071512|143101807|OTHER|||||||0.17|||||||Mixed Models Analysis|||Analysis used all available data from subjects, including those who dropped out early.||||0.17
71801031|NCT01071512|143101808|OTHER|||||||0.6|||||||Mixed Models Analysis|||Analysis used all available data||||0.6
71801032|NCT01071512|143101809|OTHER|||||||0.3|||||||Mixed Models Analysis|||Analysis used all available data||||0.3
71801033|NCT01071512|143101810|OTHER|||||||0.02|||||||Mixed Models Analysis|||Analysis used all available data||||0.02
71801034|NCT01071512|143101811|OTHER|||||||0.9|||||||Mixed Models Analysis|||Analysis used all available data||||0.9
71801035|NCT02076412|143101831|SUPERIORITY||Risk Difference (RD)|13.8||||0.1519|TWO_SIDED|95.0|0.5|27.1|||Fisher Exact||Confidence interval for treatment difference (risk difference) was based on the normal approximation|||27.1|0.5|0.1519
71801036|NCT02076412|143101836|SUPERIORITY||Risk Difference (RD)|-0.01||||0.4927|TWO_SIDED|95.0|-0.05|0.02||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.02|-0.05|0.4927
71801037|NCT02076412|143101837|SUPERIORITY||Risk Difference (RD)|-0.12||||0.2499|TWO_SIDED|95.0|-0.32|0.09||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided|||||0.09|-0.32|0.2499
71801038|NCT01312766|143101857|NON_INFERIORITY_OR_EQUIVALENCE|The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.|Mean Difference (Final Values)|1.9||||0.012|TWO_SIDED|95.0|0.43|3.43|||ANOVA|||||3.43|0.43|0.012
71893602|NCT03952130|143308542|OTHER||Relative rate|1.19||||0.409|TWO_SIDED|95.0|0.79|1.79|||Negative binomial regression|||\<=2 hours post meal||1.79|0.79|0.409
71893603|NCT03952130|143308542|OTHER||Relative rate|1.22||||0.217|TWO_SIDED|95.0|0.89|1.68|||Negative binomial regression|||\<=4 hours post meal||1.68|0.89|0.217
71893604|NCT03952130|143308542|OTHER||Relative rate|1.09||||0.703|TWO_SIDED|95.0|0.71|1.65|||Negative binomial regression|||\>1 to \<=2 hours post meal||1.65|0.71|0.703
71801039|NCT01312766|143101858|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||ANOVA|||||||0.25
71801040|NCT01312766|143101860|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.90
71801041|NCT01312766|143101861|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||ANOVA|||||||0.02
71801042|NCT01312766|143101864|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
71801043|NCT01312766|143101865|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
71801044|NCT01312766|143101866|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||ANOVA|||||||0.004
71801045|NCT01312766|143101867|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANOVA|||||||<0.001
71801046|NCT01312766|143101868|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||ANOVA|||||||0.04
71801047|NCT01312766|143101869|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||||||0.61
71801048|NCT03246529|143101882|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified Cochran-Mantel-Haenszel (CMH) test (by response status and baseline platelet count),||||||<0.0001
71801049|NCT03246529|143101883|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71801050|NCT03246529|143101884|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71801051|NCT03117387|143101922|OTHER|Bland-Altman analysis estimates bias between TOF-Cuff and electromyography.|bias|0.0|||||TWO_SIDED|0.05|-0.05|0.05||||||"Paired measurements were compared using a Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method\_agreement\_analysis, Leiden, the Netherlands).~This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects."||0.05|-0.05|
71801052|NCT00320281|143101944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432||95.0|||||ANCOVA|||||||0.432
71801053|NCT01856140|143101946|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.52
71801054|NCT01856140|143101946|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.47
71801055|NCT01856140|143101946|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.52
71801056|NCT01856140|143101947|OTHER|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.227
71801057|NCT01856140|143101947|OTHER|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.573
71801058|NCT01856140|143101947|OTHER|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||||||0.588
71801059|NCT01856140|143101948|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.262
71801060|NCT01856140|143101948|OTHER|||||||0.631|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks.||||0.631
71801061|NCT01856140|143101948|OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.796
71801062|NCT01856140|143101949|OTHER|||||||0.337|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at baseline||||0.337
71801063|NCT01856140|143101949|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 6 weeks||||0.078
71801064|NCT01856140|143101949|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two groups at post-injection 12 weeks.||||0.439
71801065|NCT00827372|143101950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0658|||||||t-test, 2 sided|||With a sample size of 14 evaluable subjects, we will have 80% power to detect a change in excess arm volume of .8 standard deviations using a two-sided paired t-test. We will have 90% power to detect a difference of .9 standard deviations. A Paired T-Test was used to test the difference in arm volume from the second baseline measurement to Cycle 2 only.||||0.0658
71801066|NCT00827372|143101951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||t-test, 2 sided|||A Paired T-Test was used to compare the IFP affected at first versus affected at last reading.||||0.0061
71801067|NCT00827372|143101952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0143|||||||t-test, 2 sided|||A Paired T-Test was used for the difference in the impedance ratio from the second baseline to cycle 2, day 1||||0.0143
71801068|NCT04011475|143101955|OTHER|||||||0.0276|||||||Log Rank|||||||0.0276
71801069|NCT04011475|143101955|OTHER||Hazard Ratio (HR)|0.875||||0.6665|TWO_SIDED|95.0|0.47|1.604|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group B using group B as reference.|||1.604|0.47|0.6665
71801070|NCT04011475|143101955|OTHER||Hazard Ratio (HR)|2.377||||0.031|TWO_SIDED|95.0|1.083|5.221|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group A versus group C using group C as reference.|||5.221|1.083|0.0310
71801071|NCT04011475|143101955|OTHER||Hazard Ratio (HR)|2.716||||0.0116|TWO_SIDED|95.0|1.25|5.901|||Regression, Cox||Hazard Ratio (HR) was from Cox regression comparing group B versus group C using group C as reference.|||5.901|1.250|0.0116
71801072|NCT04011475|143101956|OTHER||Rate ratio|0.67||||0.0756|TWO_SIDED|95.0|0.43|1.04|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.04|0.43|0.0756
71801073|NCT04011475|143101956|OTHER||Rate ratio|4.36|||<|0.0001|TWO_SIDED|95.0|2.27|8.4|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||8.40|2.27|< 0.0001
71801074|NCT04011475|143101956|OTHER||Rate ratio|0.34||||0.0022|TWO_SIDED|95.0|0.17|0.68|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.68|0.17|0.0022
71893605|NCT03952130|143308542|OTHER||Relative rate|1.24||||0.206|TWO_SIDED|95.0|0.89|1.73|||Negative binomial regression|||\>2 to \<=4 hours post meal||1.73|0.89|0.206
71893606|NCT03952130|143308542|OTHER||Relative rate|0.75||||0.082|TWO_SIDED|95.0|0.55|1.04|||Negative binomial regression|||\>4 hours post meal||1.04|0.55|0.082
71801075|NCT04011475|143101957|OTHER||Rate ratio|1.25||||0.7394|TWO_SIDED|95.0|0.34|4.65|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||4.65|0.34|0.7394
71801076|NCT04011475|143101958|OTHER||Rate ratio|0.65||||0.1116|TWO_SIDED|95.0|0.38|1.11|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.11|0.38|0.1116
71801077|NCT04011475|143101958|OTHER||Rate ratio|3.78||||0.0004|TWO_SIDED|95.0|1.81|7.88|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||7.88|1.81|0.0004
71801078|NCT04011475|143101958|OTHER||Rate ratio|0.41||||0.0239|TWO_SIDED|95.0|0.19|0.89|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.89|0.19|0.0239
71801079|NCT04011475|143101959|OTHER||Rate ratio|0.71||||0.4164|TWO_SIDED|95.0|0.32|1.61|||Z-test||The rate ratio was from Poisson regression for Group A versus Group B using Group B as the reference group.|||1.61|0.32|0.4164
71801080|NCT04011475|143101959|OTHER||Rate ratio|7.0||||0.01|TWO_SIDED|95.0|1.59|30.8|||Z-test||The rate ratio was from Poisson regression for Group B versus Group C using Group C as the reference group.|||30.8|1.59|0.0100
71801081|NCT04011475|143101959|OTHER||Rate ratio|0.2||||0.0377|TWO_SIDED|95.0|0.04|0.91|||Z-test||The rate ratio was from Poisson regression for Group C versus Group A using Group A as the reference group.|||0.91|0.04|0.0377
71801082|NCT04011475|143101960|OTHER|||||||0.2035|||||||Log Rank|||||||0.2035
71893607|NCT03952130|143308543|OTHER||LS Mean Difference|-0.29||||0.309|TWO_SIDED|95.0|-0.86|0.27|||Mixed Models Analysis|||||0.27|-0.86|0.309
71801083|NCT04011475|143101961|OTHER|||||||0.1858|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.1858
71801084|NCT04011475|143101962|OTHER|||||||0.0144|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0144
71801085|NCT04011475|143101962|OTHER|||||||0.9219|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9219
71801086|NCT04011475|143101962|OTHER|||||||0.959|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.9590
71801087|NCT04011475|143101963|OTHER|||||||0.2909|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2909
71801088|NCT04011475|143101963|OTHER|||||||0.1618|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.1618
71801089|NCT04011475|143101963|OTHER|||||||0.4695|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.4695
71801090|NCT04011475|143101964|OTHER||||||>|0.9999|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||> 0.9999
71801091|NCT04011475|143101964|OTHER|||||||0.2516|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.2516
71801092|NCT04011475|143101964|OTHER|||||||0.0036|||||||Pair t-test|Pair t-test was used for assessing the intra-group difference.||||||0.0036
71801093|NCT04011475|143101965|OTHER|||||||0.6189|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.6189
71801094|NCT04011475|143101965|OTHER|||||||0.7656|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.7656
71801095|NCT04011475|143101965|OTHER|||||||0.3594|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was used for assessing the intra-group difference.||||||0.3594
71801096|NCT04011475|143101966|OTHER|||||||0.0483|||||||Chi-squared|Chi-square test was applied for assessing the inter-group difference.||||||0.0483
71801097|NCT05036642|143102040|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.02
71801098|NCT05036642|143102041|OTHER|||||||0.01|||||||ANOVA|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.01
71801099|NCT05036642|143102042|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Difference in measurements from 'no device' (baseline) to 'with device.'||||0.48
71801100|NCT00630877|143102047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71801101|NCT00630877|143102049|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
71801102|NCT00630877|143102050|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
71801103|NCT00630877|143102051|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
71801104|NCT00630877|143102052|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Spearman rank-order correlation|||||||<0.0001
71801105|NCT00630877|143102053|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Independent groups t-test|||||||0.002
71801106|NCT00630877|143102054|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Independent groups t-test|||||||<0.001
71801107|NCT02873923|143102058|OTHER||Correlation coefficient|0.66|||||TWO_SIDED|95.0|0.63|0.68|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.68|0.63|
71801108|NCT02873923|143102059|OTHER||correlation coefficient|0.0|||||TWO_SIDED|95.0|0.0|0.005|||||||As of today, the meta-analytic surrogacy evaluation scheme proposed by Buyse and Burzykowski et al. is considered as the most statistically rigorous method for the validation of surrogate endpoints. This approach requires individual-patient data (IPD) from multiple randomized clinical trials (RCT) with similar design and treatment to address surrogacy from a multi-level framework. At the patient level, the surrogate endpoint should be correlated and predictive of the final endpoint regardless of the treatment (individual level association). At the trial level, the treatment effect on the surrogate endpoint should be correlated and predictive of the treatment effect on the final endpoint (trial-level association). Individual-level and trial-level associations estimated using weighted linear regression and the two-stage model introduced by Buyse and Burzykowski.|0.005|0.00|
71801109|NCT01610700|143102064|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-5.93||||0.124||95.0|-13.52|1.65|||ANCOVA|||The change in the primary impairment was compared between treatment groups using analysis of covariance (ANCOVA) with baseline primary impairment score as the covariate.||1.65|-13.52|0.124
71801110|NCT01610700|143102065|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.062|TWO_SIDED|95.0|-14.56|0.37|||ANCOVA|||The change in the spasticity visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.37|-14.56|0.062
71801111|NCT01610700|143102066|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.88||||0.731|TWO_SIDED|95.0|-12.73|8.96|||ANCOVA|||The change in the pain visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||8.96|-12.73|0.731
71801112|NCT01610700|143102067|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-3.3||||0.443|TWO_SIDED|95.0|-11.82|5.21|||ANCOVA|||The change in the muscle spasm visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||5.21|-11.82|0.443
71801113|NCT01610700|143102068|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.85||||0.311|TWO_SIDED|95.0|-20.31|6.6|||ANCOVA|||The change in the tremor visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.60|-20.31|0.311
71801114|NCT01610700|143102069|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.26|STANDARD_ERROR_OF_MEAN|4.36||0.154|TWO_SIDED|95.0|-14.9|2.38|||ANCOVA|||The change in bladder problems visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.38|-14.90|0.154
71801115|NCT01610700|143102070|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.293|TWO_SIDED|95.0|0.77|2.43|||Fisher Exact|||The proportion of subjects with better/much better assessments was compared between groups using a Fisher's Exact Test.||2.43|0.77|0.293
71801116|NCT01610700|143102072|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.69||||0.45|TWO_SIDED|95.0|-1.11|2.5|||ANCOVA|||The change from baseline in the mean Beck's Depression Inventory score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.50|-1.11|0.450
71801117|NCT01610700|143102073|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12||||0.427|TWO_SIDED|95.0|-0.43|0.18|||ANCOVA|||The change baseline in the mean Fatigue Severity Scale Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.18|-0.43|0.427
71801118|NCT01610700|143102075|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.72||||0.647|TWO_SIDED|95.0|-2.38|3.82|||ANCOVA|||The change from baseline in the mean total 28-item General Health Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.82|-2.38|0.647
71801119|NCT01610700|143102077|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.12|STANDARD_ERROR_OF_MEAN|0.83||0.889|TWO_SIDED|95.0|-1.77|1.54|||ANCOVA|||The change from baseline in the mean total bladder control test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.54|-1.77|0.889
71801120|NCT01610700|143102080|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.1||||0.047|TWO_SIDED|95.0|-14.11|-0.08|||ANCOVA|||The from baseline in the mean sleep quality 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||-0.08|-14.11|0.047
71801121|NCT01610700|143102081|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.53||||0.198|TWO_SIDED|95.0|-11.45|2.4|||ANCOVA|||The change from baseline in the mean sleep amount 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||2.40|-11.45|0.198
71801122|NCT01610700|143102082|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.36||||0.717|TWO_SIDED|95.0|-8.8|6.07|||ANCOVA|||The from baseline in the mean feeling upon wakening 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||6.07|-8.80|0.717
71801123|NCT01610700|143102083|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.47||||0.087|TWO_SIDED|95.0|-1.01|0.07|||ANCOVA|||The change from baseline in the mean Barthel Activities for Daily Living scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||0.07|-1.01|0.087
71801124|NCT01610700|143102087|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|1.81||||0.048|TWO_SIDED|95.0|0.02|3.6|||ANCOVA|||The change from baseline in the mean Guy's Neurological Disability Scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||3.60|0.02|0.048
71801125|NCT01610700|143102088|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.904|TWO_SIDED|95.0|-1.85|1.64|||ANCOVA|||The change from baseline in the mean Atkinson Morley Information Processing Battery test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.||1.64|-1.85|0.904
71801126|NCT03143829|143102103|OTHER|||||||0.083|||||||t-test, 2 sided|||Differences at week 10||||0.083
71801127|NCT03143829|143102104|OTHER|||||||0.099|||||||t-test, 2 sided|||Descriptive comparison||||.099
71801128|NCT03143829|143102105|OTHER|||||||0.558|||||||t-test, 2 sided|||comparison at time 4||||.558
71801129|NCT03143829|143102106|OTHER|||||||0.153|||||||Chi-squared|||descriptive comparison of resource use||||.153
71801130|NCT02391948|143102113|OTHER||mean population value age 12|98.3|||||TWO_SIDED|95.0|97.8|98.6||||||||98.6|97.8|
71801131|NCT02391948|143102113|OTHER||mean population value age 12|89.1|||||TWO_SIDED|95.0|86.6|91.1||||||||91.1|86.6|
71801132|NCT02391948|143102113|OTHER||mean population value age 12|50.1|||||TWO_SIDED|95.0|46.5|53.6||||||||53.6|46.5|
71801133|NCT02391948|143102113|OTHER||mean population value age 12|25.3|||||TWO_SIDED|95.0|23.7|27.0||||||||27.0|23.7|
71801134|NCT02391948|143102113|OTHER||mean population value age 12|6.48|||||TWO_SIDED|95.0|5.66|7.38||||||||7.38|5.66|
71801135|NCT02391948|143102114|OTHER||mean population value age 12|0.44|||||TWO_SIDED|95.0|0.38|0.49||||||||0.49|0.38|
71801136|NCT02391948|143102114|OTHER||mean population value age 12|0.68|||||TWO_SIDED|95.0|0.6|0.77||||||||0.77|0.60|
71801137|NCT02391948|143102114|OTHER||mean population value age 12|0.93|||||TWO_SIDED|95.0|0.79|1.07||||||||1.07|0.79|
71801138|NCT02391948|143102114|OTHER||mean population value age 12|1.38|||||TWO_SIDED|95.0|1.22|1.54||||||||1.54|1.22|
71801139|NCT02391948|143102114|OTHER||mean population value age 12|2.16|||||TWO_SIDED|95.0|2.01|2.31||||||||2.31|2.01|
71893608|NCT03952130|143308544|OTHER||LS Mean Difference|-15.7|||<|0.001|TWO_SIDED|95.0|-23.8|-7.7|||Mixed Models Analysis|||Morning premeal-fasting||-7.7|-23.8|<.001
71801140|NCT02391948|143102115|OTHER||mean population value|4.49|||||TWO_SIDED|95.0|4.43|4.54||||||||4.54|4.43|
71801141|NCT02391948|143102115|OTHER||mean population value|4.1|||||TWO_SIDED|95.0|3.99|4.2||||||||4.20|3.99|
71801142|NCT02391948|143102115|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.75|4.25||||||||4.25|3.75|
71801143|NCT02391948|143102115|OTHER||mean population value|2.95|||||TWO_SIDED|95.0|2.73|3.19||||||||3.19|2.73|
71801144|NCT02391948|143102115|OTHER||mean population value|1.59|||||TWO_SIDED|95.0|1.44|1.75||||||||1.75|1.44|
71801145|NCT02391948|143102116|OTHER||mean population value|1362.3|||||TWO_SIDED|95.0|1313.6|1410.7||||||||1410.7|1313.6|
71801146|NCT02391948|143102116|OTHER||mean population value|1096.33|||||TWO_SIDED|95.0|1028.8|1158.62||||||||1158.62|1028.80|
71801147|NCT02391948|143102116|OTHER||mean population value|592.62|||||TWO_SIDED|95.0|533.79|652.72||||||||652.72|533.79|
71801148|NCT02391948|143102117|OTHER||mean population value|3.99|||||TWO_SIDED|95.0|3.91|4.07||||||||4.07|3.91|
71801149|NCT02391948|143102117|OTHER||mean population value|3.49|||||TWO_SIDED|95.0|3.39|3.6||||||||3.60|3.39|
71801150|NCT02391948|143102117|OTHER||mean population value|3.23|||||TWO_SIDED|95.0|3.08|3.37||||||||3.37|3.08|
71801151|NCT02391948|143102117|OTHER||mean population value|2.8|||||TWO_SIDED|95.0|2.67|2.93||||||||2.93|2.67|
71801152|NCT02391948|143102117|OTHER||mean population value|1.79|||||TWO_SIDED|95.0|1.67|1.91||||||||1.91|1.67|
71801153|NCT02391948|143102118|OTHER||mean population value|0.59|||||TWO_SIDED|9.0|0.47|0.72||||||||0.72|0.47|
71801154|NCT02391948|143102118|OTHER||mean population value|1.1|||||TWO_SIDED|95.0|0.91|1.3||||||||1.30|0.91|
71801155|NCT02391948|143102118|OTHER||mean population value|0.68|||||TWO_SIDED|95.0|0.48|0.89||||||||0.89|0.48|
71801156|NCT02391948|143102118|OTHER||mean population value|1.38|||||TWO_SIDED|95.0|1.12|1.65||||||||1.65|1.12|
71801157|NCT02391948|143102118|OTHER||mean population value|2.33|||||TWO_SIDED|95.0|2.08|2.6||||||||2.60|2.08|
71840974|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-62.755||||0.0807|TWO_SIDED|95.0|-133.221|7.71|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||7.710|-133.221|0.0807
71801158|NCT02391948|143102119|OTHER||mean population value age 12|70.6|||||TWO_SIDED|95.0|69.1|72.0||||||||72.0|69.1|
71801159|NCT02391948|143102119|OTHER||mean population value age 12|62.1|||||TWO_SIDED|95.0|59.4|65.0||||||||65.0|59.4|
71801160|NCT02391948|143102119|OTHER||mean population value age 12|62.9|||||TWO_SIDED|95.0|60.9|65.0||||||||65.0|60.9|
71801161|NCT02391948|143102119|OTHER||mean population value age 12|58.2|||||TWO_SIDED|95.0|56.7|59.7||||||||59.7|56.7|
71801162|NCT02391948|143102119|OTHER||mean population value age 12|51.9|||||TWO_SIDED|95.0|50.2|53.6||||||||53.6|50.2|
71801163|NCT02391948|143102120|OTHER||mean population value age 12|78.3|||||TWO_SIDED|95.0|76.0|80.4||||||||80.4|76.0|
71801164|NCT02391948|143102120|OTHER||mean population value age 12|66.1|||||TWO_SIDED|95.0|63.5|68.5||||||||68.5|63.5|
71801165|NCT02391948|143102120|OTHER||mean population value age 12|60.5|||||TWO_SIDED|95.0|57.3|63.3|||mean population value age 12|||||63.3|57.3|
71801166|NCT02391948|143102120|OTHER||mean population value age 12|37.9|||||TWO_SIDED|95.0|35.6|40.3||||||||40.3|35.6|
71801167|NCT02391948|143102120|OTHER||mean population value age 12|14.5|||||TWO_SIDED|95.0|12.4|16.5||||||||16.5|12.4|
71801168|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.06|2.02|||||Data from all GMFCS levels was used, country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in family-centredness outcome.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor family-centred service.||2.02|1.06|
71801169|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.07|2.03|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor parents' perception of needs being met.||2.03|1.07|
71801170|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.96|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in the amount of focus on environment.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.38|0.96|
71801171|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|1.07|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in focus on participation.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.58|1.07|
71801172|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of physical therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of physical therapy services.||1.58|0.72|
71801173|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.74|1.28|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of occupational therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of occupational therapy.||1.28|0.74|
71801174|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.25|||||TWO_SIDED|95.0|0.97|1.6|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of speech and language therapy.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of speech and language therapy.||1.60|0.97|
71801175|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.88|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor family-centred service.||1.88|1.00|
71801176|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.78|1.44|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor family-centred service.||1.44|0.78|
71801177|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.54|1.26|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor family-centred service.||1.26|0.54|
71801178|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.37|||||TWO_SIDED|95.0|1.0|1.87|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor parents' perception of needs being met.||1.87|1.00|
71801179|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.83|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor parents' perception of needs being met.||1.53|0.83|
71801180|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.59|1.3|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor parents' perception of needs being met.||1.3|0.59|
71801181|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.9|1.29|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.29|0.9|
71801182|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.86|1.22||||||Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.22|0.86|
71801183|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.7|1.13|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).||1.13|0.7|
71801184|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.9|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.31|0.9|
71801185|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.91|1.32|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.32|0.91|
71801186|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.76|1.24|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor focus on participation (structured play/recreation/leisure activities).||1.24|0.76|
71801187|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of physical therapy services.||1.15|.7|
71801188|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.74|1.48|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of physical therapy services.||1.48|.74|
71801189|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.72|1.21|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life -Self Care outcome for the predictor amount of occupational therapy.||1.21|.72|
71893609|NCT03952130|143308544|OTHER||LS Mean Difference|-14.0||||0.005|TWO_SIDED|95.0|-23.8|-4.2|||Mixed Models Analysis|||Morning 1-hour post meal||-4.2|-23.8|0.005
71893610|NCT03952130|143308544|OTHER||LS Mean Difference|-14.9||||0.004|TWO_SIDED|95.0|-25.0|-4.8|||Mixed Models Analysis|||Morning 2-hour post meal||-4.8|-25.0|0.004
71893611|NCT03952130|143308544|OTHER||LS Mean Difference|-2.3||||0.616|TWO_SIDED|95.0|-11.4|6.8|||Mixed Models Analysis|||Midday premeal||6.8|-11.4|0.616
71801190|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.89|1.5|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of occupational therapy.||1.5|.89|
71801191|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.65|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of occupational therapy.||1.38|.65|
71801192|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.81|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of speech and language therapy.||1.31|.81|
71801193|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.87|1.39|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of speech and language therapy.||1.39|.87|
71801194|NCT02391948|143102121|OTHER||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.6|1.25|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of speech and language therapy.||1.25|.6|
71801195|NCT02391948|143102121|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.92|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of physical therapy services.||1.53|.92|
71801196|NCT02391948|143102125|OTHER||population average|2319.0|||||TWO_SIDED|95.0|1460.0|3218.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3218|1460|
71801197|NCT02391948|143102125|OTHER||population average|1858.0|||||TWO_SIDED|95.0|1233.0|2530.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||2530|1233|
71801198|NCT02391948|143102126|OTHER||population average|5240.0|||||TWO_SIDED|95.0|3874.0|6670.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||6670|3874|
71893612|NCT03952130|143308544|OTHER||LS Mean Difference|-9.1||||0.054|TWO_SIDED|95.0|-18.4|0.1|||Mixed Models Analysis|||Midday 1-hour post meal||0.1|-18.4|0.054
71893613|NCT03952130|143308544|OTHER||LS Mean Difference|-3.3||||0.483|TWO_SIDED|95.0|-12.6|6.0|||Mixed Models Analysis|||Midday 2-hour post meal||6.0|-12.6|0.483
71801199|NCT02391948|143102126|OTHER||population average|4319.0|||||TWO_SIDED|95.0|3258.0|5443.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||5443|3258|
71801200|NCT02391948|143102127|OTHER||population average|108.0|||||TWO_SIDED|95.0|67.0|151.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||151|67|
71801201|NCT02391948|143102127|OTHER||population average|100.0|||||TWO_SIDED|95.0|58.0|145.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||145|58|
71801202|NCT02391948|143102127|OTHER||population average|10.0|||||TWO_SIDED|95.0|0.0|35.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||35|0|
71801203|NCT02391948|143102128|OTHER||population average|2815.0|||||TWO_SIDED|95.0|2025.0|3650.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3650|2025|
71893614|NCT03952130|143308544|OTHER||LS Mean Difference|10.5||||0.064|TWO_SIDED|95.0|-0.6|21.7|||Mixed Models Analysis|||Evening premeal||21.7|-0.6|0.064
71893615|NCT03952130|143308544|OTHER||LS Mean Difference|-5.6||||0.262|TWO_SIDED|95.0|-15.5|4.2|||Mixed Models Analysis|||Evening 1-hour post meal||4.2|-15.5|0.262
71893616|NCT03952130|143308544|OTHER||LS Mean Difference|-7.8||||0.117|TWO_SIDED|95.0|-17.5|2.0|||Mixed Models Analysis|||Evening 2-hour post meal||2.0|-17.5|0.117
71893617|NCT03952130|143308544|OTHER||LS Mean Difference|-4.4||||0.414|TWO_SIDED|95.0|-15.1|6.2|||Mixed Models Analysis|||Bedtime||6.2|-15.1|0.414
71893618|NCT03952130|143308545|OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||Basal insulin dose||0.6|-0.7|0.947
71840975|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-68.83||||0.0095|TWO_SIDED|95.0|-120.753|-16.907|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-16.907|-120.753|0.0095
71840976|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-1.593||||0.9586|TWO_SIDED|95.0|-61.873|58.687|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||58.687|-61.873|0.9586
71675275|NCT01908829|142868061|SUPERIORITY||LS Means|-0.35|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.54|-0.17||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.17|-0.54|<0.001
71801204|NCT02391948|143102128|OTHER||population average|3109.0|||||TWO_SIDED|95.0|2502.0|3739.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.||3739|2502|
71801205|NCT02391948|143102128|OTHER||population average|1056.0|||||TWO_SIDED|95.0|471.0|1665.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.||1665|471|
71801206|NCT04713748|143102133|OTHER||||||<|0.0001|||||||Interclass correlation coefficient|||||||<0.0001
71801207|NCT00113516|143102135|SUPERIORITY_OR_OTHER||probability|0.405|||||TWO_SIDED|90.0|0.315|0.494|||Kaplan-Meier||The probability of survival along with the corresponding confidence interval (CI) (for the log \[-log (1-year survival rate)\]) was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival rate itself.|The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.||0.494|0.315|
71801208|NCT00113516|143102139|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|27.4|||||TWO_SIDED|95.0|18.2|38.2||||||||38.2|18.2|
71801209|NCT00113516|143102153|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Wilcoxon Rank Sum Test|||||||0.474
71801210|NCT00113516|143102154|SUPERIORITY_OR_OTHER|||||||0.836||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.836
71893619|NCT03952130|143308545|OTHER||LS Mean Difference|0.7||||0.5|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Analysis|||Bolus insulin dose||2.6|-1.3|0.500
71893620|NCT03952130|143308545|OTHER||LS Mean Difference|0.6||||0.543|TWO_SIDED|95.0|-1.4|2.7|||Mixed Models Analysis|||Total insulin dose||2.7|-1.4|0.543
71801211|NCT00113516|143102154|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.071
71801212|NCT00113516|143102154|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.393
71801213|NCT00113516|143102154|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.029
71893621|NCT03952130|143308546|OTHER||Odds Ratio (OR)|0.81||||0.462|TWO_SIDED|95.0|0.47|1.42|||Regression, Logistic|||For HbA1c \< 7%||1.42|0.47|0.462
71801214|NCT00113516|143102154|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.247
71801215|NCT00113516|143102155|SUPERIORITY_OR_OTHER|||||||0.305||95.0|||||Wilcoxon Rank Sum Test|||||||0.305
71801216|NCT00113516|143102156|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.738
71801217|NCT00113516|143102156|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.438
71801218|NCT00113516|143102156|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.236
71801219|NCT00113516|143102156|SUPERIORITY_OR_OTHER|||||||0.287||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.287
71801220|NCT00113516|143102156|SUPERIORITY_OR_OTHER|||||||0.772||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.772
71801221|NCT00113516|143102157|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||Wilcoxon Rank Sum Test|||||||0.537
71893622|NCT03952130|143308546|OTHER||Odds Ratio (OR)|0.54||||0.089|TWO_SIDED|95.0|0.26|1.1|||Regression, Logistic|||For HbA1c ≤6.5%||1.10|0.26|0.089
71801222|NCT00113516|143102158|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.813
71801223|NCT00113516|143102158|SUPERIORITY_OR_OTHER|||||||0.849||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.849
71801224|NCT00113516|143102158|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.121
71801225|NCT00113516|143102158|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.582
71801226|NCT00113516|143102158|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.383
71801227|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.6782|TWO_SIDED|95.0|0.61|2.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.15|0.61|0.6782
71801228|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.198|TWO_SIDED|95.0|0.77|3.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.30|0.77|0.1980
71801229|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.1344|TWO_SIDED|95.0|0.82|3.98|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.98|0.82|0.1344
71801230|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
71801231|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6||||0.0153|TWO_SIDED|95.0|1.19|11.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 1||11.13|1.19|0.0153
71801232|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 3, Day 28||14.37|0.52|0.2085
71801233|NCT00113516|143102159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group|Cycle 5, Day 28||23.57|0.08|0.8084
71801234|NCT00113516|143102160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.507|TWO_SIDED|95.0|0.65|2.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.39|0.65|0.5070
71801235|NCT00113516|143102160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4474|TWO_SIDED|95.0|0.63|2.82|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||2.82|0.63|0.4474
71801236|NCT00113516|143102160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7599|TWO_SIDED|95.0|0.4|1.95|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.95|0.40|0.7599
71801237|NCT00113516|143102160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
71801238|NCT00113516|143102160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6878|TWO_SIDED|95.0|0.43|3.58|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||3.58|0.43|0.6878
71801239|NCT00113516|143102160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
71801240|NCT00113516|143102161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5277|TWO_SIDED|95.0|0.39|1.62|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.62|0.39|0.5277
71801241|NCT00113516|143102161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.466|TWO_SIDED|95.0|0.58|3.29|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 1, Day 28||3.29|0.58|0.4660
71801242|NCT00113516|143102161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5337|TWO_SIDED|95.0|0.52|3.44|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 1||3.44|0.52|0.5337
71801243|NCT00113516|143102161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
71801244|NCT00113516|143102161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.2948|TWO_SIDED|95.0|0.54|7.07|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 1||7.07|0.54|0.2948
71801245|NCT00113516|143102161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \>=Median Cutpoint group hazard to \<Median Cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
71801246|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.7824|TWO_SIDED|95.0|0.56|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.56|0.7824
71801247|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1918|TWO_SIDED|95.0|0.77|3.47|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.47|0.77|0.1918
71801248|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.1093|TWO_SIDED|95.0|0.85|4.3|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||4.30|0.85|0.1093
71801249|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.4809|TWO_SIDED|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||3.39|0.56|0.4809
71801250|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.2||||0.011|TWO_SIDED|95.0|1.26|13.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||13.85|1.26|0.0110
71801251|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.7||||0.2085|TWO_SIDED|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||14.37|0.52|0.2085
71801252|NCT00113516|143102162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.8084|TWO_SIDED|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||23.57|0.08|0.8084
71801253|NCT00113516|143102163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.5215|TWO_SIDED|95.0|0.62|2.53|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.53|0.62|0.5215
71801254|NCT00113516|143102163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2504|TWO_SIDED|95.0|0.72|3.49|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.49|0.72|0.2504
71801255|NCT00113516|143102163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8766|TWO_SIDED|95.0|0.42|2.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.11|0.42|0.8766
71801256|NCT00113516|143102163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0109|TWO_SIDED|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||0.80|0.12|0.0109
71801257|NCT00113516|143102163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.5627|TWO_SIDED|95.0|0.46|4.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||4.18|0.46|0.5627
71801258|NCT00113516|143102163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.7||||0.4637|TWO_SIDED|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||8.12|0.38|0.4637
71801259|NCT00113516|143102164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.6682|TWO_SIDED|95.0|0.39|1.84|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.84|0.39|0.6682
71801260|NCT00113516|143102164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.6854|TWO_SIDED|95.0|0.49|3.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.00|0.49|0.6854
71801261|NCT00113516|143102164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.6028|TWO_SIDED|95.0|0.49|3.37|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.37|0.49|0.6028
71801262|NCT00113516|143102164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0712|TWO_SIDED|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.13|0.13|0.0712
71801263|NCT00113516|143102164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.3411|TWO_SIDED|95.0|0.5|7.15|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||7.15|0.50|0.3411
71801264|NCT00113516|143102164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.3||||0.32|TWO_SIDED|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||38.48|0.28|0.3200
71801265|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.4768|TWO_SIDED|95.0|0.7|2.17|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.17|0.70|0.4768
71801266|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.1484|TWO_SIDED|95.0|0.84|3.13|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.13|0.84|0.1484
71801267|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8957|TWO_SIDED|95.0|0.5|2.18|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||2.18|0.50|0.8957
71801268|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5681|TWO_SIDED|95.0|0.33|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.85|0.33|0.5681
71801269|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.8||||0.0074|TWO_SIDED|95.0|1.35|10.88|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||10.88|1.35|0.0074
71801270|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.1637|TWO_SIDED|95.0|0.06|1.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.70|0.06|0.1637
71801271|NCT00113516|143102165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.4328|TWO_SIDED|95.0|0.23|29.12|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||29.12|0.23|0.4328
71801272|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.4269|TWO_SIDED|95.0|0.72|2.21|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||2.21|0.72|0.4269
71801273|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.0|0.51|1.86|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||1.86|0.51|0.9290
71801274|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.8195|TWO_SIDED|95.0|0.44|1.91|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||1.91|0.44|0.8195
71801275|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.221|TWO_SIDED|95.0|0.26|1.38|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.38|0.26|0.2210
71801276|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.4297|TWO_SIDED|95.0|0.24|1.85|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||1.85|0.24|0.4297
71801277|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0522|TWO_SIDED|95.0|0.06|1.11|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||1.11|0.06|0.0522
71801278|NCT00113516|143102166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.6949|TWO_SIDED|95.0|0.05|7.0|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||7.00|0.05|0.6949
71801279|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.766|TWO_SIDED|95.0|0.51|1.65|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 1||1.65|0.51|0.7660
71801280|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.2682|TWO_SIDED|95.0|0.72|3.23|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 1, Day 28||3.23|0.72|0.2682
71801281|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.2726|TWO_SIDED|95.0|0.69|3.7|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 1||3.70|0.69|0.2726
71801282|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.2787|TWO_SIDED|95.0|0.22|1.55|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 2, Day 28||1.55|0.22|0.2787
71801283|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.4||||0.0241|TWO_SIDED|95.0|1.09|17.56|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 1||17.56|1.09|0.0241
71801284|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.0943|TWO_SIDED|95.0|0.59|48.81|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 3, Day 28||48.81|0.59|0.0943
71801285|NCT00113516|143102167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.8084|TWO_SIDED|95.0|0.04|11.79|||Log Rank||HR was based upon the ratio of \> = median cutpoint group hazard to \< median cutpoint group.|Cycle 5, Day 28||11.79|0.04|0.8084
71801286|NCT03759223|143102190|SUPERIORITY|||||||0.04||||||0:24 weeks|Mixed Models Analysis|||||||.04
71801287|NCT03759223|143102190|SUPERIORITY|||||||0.05||||||0:24 weeks|Mixed Models Analysis|||||||.05
71801288|NCT03759223|143102190|SUPERIORITY|||||||0.58||||||12:12 weeks|Mixed Models Analysis|||||||.58
71801289|NCT03235024|143102205|EQUIVALENCE|A sample size of 52 per group would achieve \>80% power to reject the null hypothesis of equal means when the population mean difference is μ1 - μ2 = (-1.4) - (-5.3) = 3.9 with a standard deviation for both groups of 7.0 and with a significance level (alpha) of 0.025 using a 1-sided 2-sample equal variance t-test.||||||0.0228||||||At Week 2|t-test, 1 sided|||||||0.0228
71801290|NCT01599650|143102215|SUPERIORITY_OR_OTHER||difference in LS mean|10.0|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|7.3|12.8|||ANOVA|||||12.8|7.3|<0.0001
71840977|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.635||||0.9402|TWO_SIDED|95.0|-71.714|66.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||66.443|-71.714|0.9402
71893623|NCT01713348|143308547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|3.3||0.9345|TWO_SIDED|95.0|-1.29|1.19|||t-test, 2 sided|||||1.19|-1.29|0.9345
71675276|NCT01908829|142868061|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.65|-0.25||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.65|<0.001
71801291|NCT01599650|143102215|SUPERIORITY_OR_OTHER||difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|5.8|11.6|||ANOVA|||||11.6|5.8|<0.0001
71801292|NCT02802345|143102226|SUPERIORITY||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|1.431||0.7191|TWO_SIDED|95.0|-3.33|2.3|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks).|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|"H0: There is no difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone.~Ha: There is a difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone."|2.30|-3.33|0.7191
71801293|NCT02802345|143102227|SUPERIORITY||Adjusted mean difference|-2.94|STANDARD_ERROR_OF_MEAN|2.198||0.1823|TWO_SIDED|95.0|-7.27|1.39|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.||1.39|-7.27|0.1823
71801294|NCT02802345|143102228|SUPERIORITY||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|1.631||0.1809|TWO_SIDED|95.0|-5.4|1.02|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment-by-visit and baseline SGRQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||1.02|-5.40|0.1809
71801295|NCT02802345|143102229|SUPERIORITY||Adjusted mean difference|-2.41|STANDARD_ERROR_OF_MEAN|2.529||0.3421|TWO_SIDED|95.0|-7.39|2.58|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment-by-visit and baseline UCSD SOBQ total score-by-visit interaction terms using an unstructured covariance matrix. No imputation was planned.||2.58|-7.39|0.3421
71801296|NCT02802345|143102230|SUPERIORITY||Percentage ratio (%)|0.83|||||TWO_SIDED|95.0|0.58|1.2|||||Within strata confidence limits are calculated according to Wald. Percentage ratio = (% of Nintedanib+sildenafil) / (% of Nintedanib+placebo).|Relative risk, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||1.20|0.58|
71801297|NCT02802345|143102230|SUPERIORITY||Percentage difference (%)|-5.37||||0.334|TWO_SIDED|95.0|-16.25|5.52|||Cochran-Mantel-Haenszel||Within strata confidence limits are calculated according to Wald. Percentage difference = (% of Nintedanib+sildenafil) - (% of Nintedanib+placebo).|Risk difference, Comparison of treatment groups is calculated by Cochran-Mantel-Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel-Haenszel type risk ratios and risk differences with 95% confidence are presented.||5.52|-16.25|0.334
71801298|NCT00835406|143102286|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-36 and Rmax at the α level of 0.05.|Ratio of the mean|97.94||||||90.0|90.96|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||105.45|90.96|
71801299|NCT00835406|143102287|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA will be performed on ln-transformed Ae0-35 and Rmax at the α level of 0.05.|Ratio of the mean|100.36||||||90.0|92.85|108.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125|||108.48|92.85|
71801300|NCT02138214|143102330|OTHER|||||||0.567||||||p-value threshold for statistical significance is 0.05|Fisher Exact|||||||0.567
71801301|NCT02138214|143102331|OTHER|||||||0.11|||||||t-test, 2 sided|||||||0.110
71801302|NCT02138214|143102333|OTHER|||||||0.758|||||||Fisher Exact|||||||0.758
71801303|NCT02138214|143102335|OTHER|||||||0.236|||||||Fisher Exact|||||||0.236
71801304|NCT02138214|143102336|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
71801305|NCT02138214|143102337|OTHER|||||||0.4|||||||t-test, 2 sided|||||||0.400
71801306|NCT02486406|143102363|SUPERIORITY||Wilson's score method|98.4|||||TWO_SIDED|95.0|91.7|99.7||||||According to the Highlights of Prescribing Information of PEGASYS, the SVR24 rate was 47% among 45 treatment-naïve pediatric participants with HCV GT1 in the NV17424 trial. To show that the DAA regimen is superior to this current standard of care by 20%, the lower bound of the 2-sided 95% confidence interval of the SVR12 rate across all participants in the study must be greater than 67%.||99.7|91.7|
71801307|NCT03221257|143102380|SUPERIORITY||Mean Difference (Net)|-0.14||||0.9326|TWO_SIDED||||||Mixed Models Analysis|||||||0.9326
71801308|NCT03221257|143102381|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9968|TWO_SIDED||||||Mixed Models Analysis|||||||0.9968
71801309|NCT03221257|143102382|SUPERIORITY||Mean Difference (Net)|0.46||||0.7489|TWO_SIDED||||||Mixed Models Analysis|||||||0.7489
71801310|NCT03221257|143102383|SUPERIORITY||Mean Difference (Net)|-9.2||||0.8898|TWO_SIDED||||||Mixed Models Analysis|||||||0.8898
71801311|NCT03221257|143102384|SUPERIORITY||Mean Difference (Net)|0.86||||0.3826|TWO_SIDED||||||Mixed Models Analysis|||||||0.3826
71801312|NCT03221257|143102385|SUPERIORITY||Mean Difference (Net)|-0.14||||0.2819|TWO_SIDED||||||Mixed Models Analysis|||||||0.2819
71801313|NCT03221257|143102386|SUPERIORITY||Mean Difference (Net)|-1.35||||0.7534|TWO_SIDED||||||Mixed Models Analysis|||||||0.7534
71801314|NCT03221257|143102387|SUPERIORITY||Mean Difference (Net)|-1.58||||0.1701|TWO_SIDED||||||ANCOVA|||||||0.1701
71801315|NCT03221257|143102388|SUPERIORITY||Mean Difference (Net)|-2.44||||0.3515|TWO_SIDED||||||ANCOVA|||||||0.3515
71801316|NCT03221257|143102389|SUPERIORITY||Mean Difference (Net)|-3.51||||0.1177|TWO_SIDED||||||ANCOVA|||||||0.1177
71801317|NCT03221257|143102390|SUPERIORITY||Mean Difference (Net)|-3.98||||0.1931|TWO_SIDED||||||ANCOVA|||||||0.1931
71801318|NCT03221257|143102391|SUPERIORITY||Mean Difference (Net)|121.3||||0.1811|TWO_SIDED||||||ANCOVA|||||||0.1811
71801319|NCT03221257|143102392|SUPERIORITY||Hazard Ratio (HR)|1.433||||0.3261|TWO_SIDED||||||Stratified log rank|||||||0.3261
71801320|NCT03221257|143102393|SUPERIORITY||Odds Ratio (OR)|1.6||||0.454|TWO_SIDED||||||Regression, Logistic|||||||0.454
71801321|NCT02442830|143102431|OTHER|Log rank test||||||0.002|||||||Log Rank|||||||.002
71801322|NCT01516879|143102435|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.97|STANDARD_ERROR_OF_MEAN|2.1|<|0.001|TWO_SIDED|95.0|-61.08|-52.85|||Repeated measures linear effects model|The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.85|-61.08|<0.001
71801323|NCT01516879|143102436|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-62.3|-53.3|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-53.3|-62.3|<0.001
71801324|NCT01516879|143102437|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|75.8|||<|0.001|TWO_SIDED|95.0|70.8|79.7|||Cochran-Mantel-Haenszel|CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.|Treatment difference using placebo as the reference.|||79.7|70.8|<0.001
71801325|NCT01516879|143102438|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.51|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-60.57|-54.45|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-54.45|-60.57|<0.001
71801326|NCT01516879|143102439|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.15|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-37.19|-33.11|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.11|-37.19|<0.001
71801327|NCT01516879|143102440|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.45|STANDARD_ERROR_OF_MEAN|1.41|<|0.001|TWO_SIDED|95.0|-36.21|-30.68|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-30.68|-36.21|<0.001
71801328|NCT01516879|143102441|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.27|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-54.25|-46.28|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-46.28|-54.25|<0.001
71801329|NCT01516879|143102442|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.21|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-47.56|-40.85|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-40.85|-47.56|<0.001
71801330|NCT01516879|143102443|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.14|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-40.41|-33.87|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-33.87|-40.41|<0.001
71801331|NCT01516879|143102444|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.21|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-49.79|-42.63|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-42.63|-49.79|<0.001
71801332|NCT01516879|143102445|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.35|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-26.15|-18.55|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.55|-26.15|<0.001
71801333|NCT01516879|143102446|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-11.54|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-17.21|-5.86|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-5.86|-17.21|<0.001
71801334|NCT01516879|143102447|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.42|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|3.28|7.56|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||7.56|3.28|<0.001
71801335|NCT01516879|143102448|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.15|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.23|-18.08|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|||-18.08|-40.23|<0.001
71801336|NCT01516879|143102449|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.14|STANDARD_ERROR_OF_MEAN|1.84||0.94|TWO_SIDED|95.0|-3.76|3.48|||ANCOVA|The ANCOVA model includes treatment group and stratification factor as covariates.|Treatment difference using placebo as the reference.|||3.48|-3.76|0.94
71801337|NCT02797262|143102451|SUPERIORITY||Mean Difference (Net)|0.02||||0.57|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)||Treatment Difference = Intervention - Control|Compared the IPAM score between two groups.||||0.57
71801338|NCT02797262|143102453|SUPERIORITY||Mean Difference (Net)|-0.02||||0.08|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the intervention period (week 0-16) between two groups.||||0.08
71893624|NCT01713348|143308547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|3.5||0.0427|TWO_SIDED|95.0|0.05|2.73|||t-test, 2 sided|||Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.||2.73|0.05|0.0427
71801339|NCT02797262|143102453|SUPERIORITY||Mean Difference (Net)|-0.02||||0.23|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the change of the plasma HIV RNA levels during the post-intervention period (week 16-28) between two groups.||||0.23
71801340|NCT02797262|143102453|SUPERIORITY||Mean Difference (Net)|-0.73||||0.03|TWO_SIDED|||||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Treatment Difference = Intervention - Control|Compared the plasma HIV RNA levels during week 4-28 between two groups.||||0.03
71801341|NCT00829621|143102472|SUPERIORITY_OR_OTHER||||||=|0.36|||||||t-test, 1 sided|||||||=0.36
71801342|NCT02139644|143102489|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.154||||0.0076|TWO_SIDED|95.0|0.041|0.267|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.267|0.041|0.0076
71801343|NCT02139644|143102489|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.131||||0.0322|TWO_SIDED|95.0|0.011|0.25|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.250|0.011|0.0322
71801344|NCT02139644|143102489|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.335||||0|TWO_SIDED|95.0|0.216|0.453|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.453|0.216|0.0000
71893625|NCT01713348|143308548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|1.18||0.8367|TWO_SIDED|95.0|-2.65|2.16|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.16|-2.65|0.8367
71893626|NCT01713348|143308548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_DEVIATION|1.05||0.7969|TWO_SIDED|95.0|-1.86|2.4|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.||||2.40|-1.86|0.7969
71801345|NCT02139644|143102489|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.325||||0|TWO_SIDED|95.0|0.203|0.447|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.447|0.203|0.0000
71801346|NCT02139644|143102490|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.262||||0|TWO_SIDED|95.0|0.168|0.356|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.356|0.168|0.0000
71801347|NCT02139644|143102490|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.266||||0|TWO_SIDED|95.0|0.172|0.36|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.172|0.0000
71801348|NCT02139644|143102490|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.151||||0.0017|TWO_SIDED|95.0|0.057|0.244|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.244|0.057|0.0017
71801349|NCT02139644|143102490|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.119||||0.0132|TWO_SIDED|95.0|0.025|0.212|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.212|0.025|0.0132
71801350|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.926||||0.0123|TWO_SIDED|95.0|2.38|19.471||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.471|2.380|0.0123
71840978|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-113.663||||0.039|TWO_SIDED|95.0|-223.33|-3.996|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-3.996|-223.330|0.0390
71840979|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-72.269||||0.4543|TWO_SIDED|95.0|-199.091|54.554|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||54.554|-199.091|0.4543
71840980|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-142.442||||0.0051|TWO_SIDED|95.0|-252.08|-32.805|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-32.805|-252.080|0.0051
71893627|NCT01713348|143308549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.6||0.0352|TWO_SIDED|95.0|-0.51|-0.02|||t-test, 2 sided|||||-0.02|-0.51|0.0352
71893628|NCT01713348|143308549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.7||0.0506|TWO_SIDED|95.0|-0.54|0.0|||t-test, 2 sided|||||0.00|-0.54|0.0506
71893629|NCT01713348|143308550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.0||0.058|TWO_SIDED|95.0|-6.4|0.1|||t-test, 2 sided|||||0.1|-6.4|0.0580
71893630|NCT01713348|143308550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|12.0||0.0002|TWO_SIDED|95.0|-13.6|-4.9|||t-test, 2 sided|||||-4.9|-13.6|0.0002
71893631|NCT01713348|143308551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|0.8||0.058|TWO_SIDED|95.0|-0.59|0.01|||t-test, 2 sided|||||0.01|-0.59|0.0580
71893632|NCT01713348|143308551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.1||0.0002|TWO_SIDED|95.0|-1.24|-0.45|||t-test, 2 sided|||||-0.45|-1.24|0.0002
71801351|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|7.018||||0.1074|TWO_SIDED|95.0|-1.531|15.567||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||15.567|-1.531|0.1074
71801352|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|20.824||||0|TWO_SIDED|95.0|12.253|29.395||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.395|12.253|0.0000
71801353|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|21.273||||0|TWO_SIDED|95.0|12.728|29.818||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||29.818|12.728|0.0000
71801354|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|9.898||||0.0233|TWO_SIDED|95.0|1.349|18.447||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.447|1.349|0.0233
71801355|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|14.255||||0.0011|TWO_SIDED|95.0|5.732|22.778||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||22.778|5.732|0.0011
71801356|NCT02139644|143102491|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|10.347||||0.0175|TWO_SIDED|95.0|1.822|18.872||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||18.872|1.822|0.0175
71801357|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.165||||0.0002|TWO_SIDED|95.0|-0.251|-0.08||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.080|-0.251|0.0002
71801358|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.143||||0.001|TWO_SIDED|95.0|-0.229|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.229|0.0010
71801359|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.23||||0|TWO_SIDED|95.0|-0.315|-0.144||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.144|-0.315|0.0000
71801360|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.194||||0|TWO_SIDED|95.0|-0.279|-0.109||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.109|-0.279|0.0000
71801361|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.064||||0.1381|TWO_SIDED|95.0|-0.15|0.021||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.021|-0.150|0.1381
71675277|NCT01908829|142868061|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.11|=|0.004|TWO_SIDED|95.0|-0.47|-0.05||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.05|-0.47|=0.004
71801362|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.051||||0.2438|TWO_SIDED|95.0|-0.136|0.035||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.035|-0.136|0.2438
71801363|NCT02139644|143102492|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.029||||0.5095|TWO_SIDED|95.0|-0.114|0.057||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.057|-0.114|0.5095
71801364|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.463||||0.0004|TWO_SIDED|95.0|-0.716|-0.209||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.209|-0.716|0.0004
71801365|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.464||||0.0003|TWO_SIDED|95.0|-0.718|-0.211||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.211|-0.718|0.0003
71801366|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.675||||0|TWO_SIDED|95.0|-0.928|-0.421||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.421|-0.928|0.0000
71801367|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.704||||0|TWO_SIDED|95.0|-0.957|-0.45||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.450|-0.957|0.0000
71801368|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.212||||0.1014|TWO_SIDED|95.0|-0.465|0.042||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.042|-0.465|0.1014
71801369|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.239||||0.064|TWO_SIDED|95.0|-0.492|0.014||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.014|-0.492|0.0640
71801370|NCT02139644|143102493|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.241||||0.0626|TWO_SIDED|95.0|-0.494|0.013||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.013|-0.494|0.0626
71801371|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1679||||||Significance level of 0.05|Log Rank|||||||0.1679
71801372|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1701||||||Significance level of 0.05|Log Rank|||||||0.1701
71801373|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0437||||||Significance level of 0.05|Log Rank|||||||0.0437
71801374|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1718||||||Significance level of 0.05|Log Rank|||||||0.1718
71801375|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3134||||||Significance level of 0.05|Log Rank|||||||0.3134
71801376|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.993||||||Significance level of 0.05|Log Rank|||||||0.9930
71801377|NCT02139644|143102494|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Significance level of 0.05|Log Rank|||||||0.9999
71801378|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.301||||0.0044|TWO_SIDED|95.0|0.094|0.508||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.508|0.094|0.0044
71801379|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0155|TWO_SIDED|95.0|0.048|0.458||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.458|0.048|0.0155
71801380|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.27|0.676||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.676|0.270|0.0000
71801381|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.23||||0.0293|TWO_SIDED|95.0|0.023|0.437||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.437|0.023|0.0293
71801382|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.172||||0.0913|TWO_SIDED|95.0|-0.028|0.372||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.372|-0.028|0.0913
71801383|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.023||||0.8216|TWO_SIDED|95.0|-0.223|0.177||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.177|-0.223|0.8216
71801384|NCT02139644|143102495|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.071||||0.4934|TWO_SIDED|95.0|-0.275|0.133||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.133|-0.275|0.4934
71801385|NCT03328897|143102498|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|0.746|<|0.001|TWO_SIDED|95.0|-5.7|-2.77|||Mixed Model with Repeated Measures(MMRM)|||||-2.77|-5.70|<0.001
71801386|NCT03328897|143102498|SUPERIORITY||Mean Difference (Net)|-3.79|STANDARD_ERROR_OF_MEAN|0.738|<|0.001|TWO_SIDED|95.0|-5.24|-2.33|||Mixed Model with Repeated Measures(MMRM)|||||-2.33|-5.24|<0.001
71801387|NCT03328897|143102499|SUPERIORITY||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|1.555|<|0.001|TWO_SIDED|95.0|-13.25|-7.14|||Mixed Model with Repeated Measures(MMRM)|||||-7.14|-13.25|<0.001
71801388|NCT03328897|143102499|SUPERIORITY||Mean Difference (Net)|-9.12|STANDARD_ERROR_OF_MEAN|1.535|<|0.001|TWO_SIDED|95.0|-12.14|-6.1|||Mixed Model with Repeated Measures(MMRM)|||||-6.10|-12.14|<0.001
71801389|NCT03328897|143102500|SUPERIORITY||Mean Difference (Net)|-5.92|STANDARD_ERROR_OF_MEAN|0.853|<|0.001|TWO_SIDED|95.0|-7.59|-4.24|||Mixed Model with Repeated Measures(MMRM)|||||-4.24|-7.59|<0.001
71801390|NCT03328897|143102500|SUPERIORITY||Mean Difference (Net)|-5.35|STANDARD_ERROR_OF_MEAN|0.842|<|0.001|TWO_SIDED|95.0|-7.0|-3.69|||Mixed Model with Repeated Measures(MMRM)|||||-3.69|-7.00|<0.001
71801391|NCT03328897|143102501|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|3.27|15.06|||Regression, Logistic|||||15.06|3.27|<0.001
71840981|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-60.12||||0.6061|TWO_SIDED|95.0|-184.286|64.046|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||64.046|-184.286|0.6061
71675278|NCT01908829|142868061|SUPERIORITY||LS Means|-0.27|STANDARD_ERROR_OF_MEAN|0.1|=|0.003|TWO_SIDED|95.0|-0.47|-0.07||P-values for pairwise comparisons were from stratified rank ANCOVA model. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.47|=0.003
71801392|NCT03328897|143102501|SUPERIORITY||Odds Ratio (OR)|7.03|||<|0.001|TWO_SIDED|95.0|3.29|15.06|||Regression, Logistic|||||15.06|3.29|<0.001
71801393|NCT03328897|143102502|SUPERIORITY||Odds Ratio (OR)|11.21|||<|0.001|TWO_SIDED|95.0|3.88|32.37|||Regression, Logistic|||||32.37|3.88|<0.001
71801394|NCT03328897|143102502|SUPERIORITY||Odds Ratio (OR)|5.88||||0.001|TWO_SIDED|95.0|2.01|17.17|||Regression, Logistic|||||17.17|2.01|0.001
71801395|NCT03328897|143102503|SUPERIORITY||Odds Ratio (OR)|2.73|||<|0.001|TWO_SIDED|95.0|1.51|4.95|||Regression, Logistic|||||4.95|1.51|<0.001
71801396|NCT03328897|143102503|SUPERIORITY||Odds Ratio (OR)|2.53||||0.002|TWO_SIDED|95.0|1.41|4.56|||Regression, Logistic|||||4.56|1.41|0.002
71801397|NCT03328897|143102504|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.7|-2.3|||Mixed Model with Repeated Measures(MMRM)|||||-2.3|-5.7|<0.001
71801398|NCT03328897|143102504|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-5.1|-1.8|||Mixed Model with Repeated Measures(MMRM)|||||-1.8|-5.1|<0.001
71801399|NCT03328897|143102505|SUPERIORITY||Hazard Ratio (HR)|1.71|||<|0.001|TWO_SIDED|95.0|1.25|2.33|||Regression, Cox|||||2.33|1.25|<0.001
71801400|NCT03328897|143102505|SUPERIORITY||Hazard Ratio (HR)|1.66||||0.001|TWO_SIDED|95.0|1.22|2.25|||Regression, Cox|||||2.25|1.22|0.001
71801401|NCT02066298|143102545|SUPERIORITY|||||||0.14|||||||exact binomial test|a priori threshold for significance was 0.025||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.14
71801402|NCT02066298|143102545|SUPERIORITY|||||||0.029||||||a priori threshold for significance was 0.025|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.||||0.029
71801403|NCT02066298|143102545|SUPERIORITY|||||||0.001||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations.||||0.001
71801404|NCT02066298|143102545|SUPERIORITY|||||||0.45||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations.||||0.45
71801405|NCT02033889|143102558|SUPERIORITY||Difference in Least Squares Means|-0.88|||<|0.001|TWO_SIDED|95.0|-1.05|-0.71|||Constrained Longitudinal Data Analysis||||Based on Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.71|-1.05|<0.001
71801406|NCT02033889|143102558|SUPERIORITY||Difference in Least Squares Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.87|-0.53|||Constrained Longitudinal Data Analysis||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-0.53|-0.87|<0.001
71801407|NCT02033889|143102560|OTHER||Difference in % vs Placebo/Glimepiride|1.5|||||TWO_SIDED|95.0|-2.1|5.4|||||||Miettinen \& Nurminen method was used to construct the 95% CI|5.4|-2.1|
71801408|NCT02033889|143102560|OTHER||Difference in % vs Placebo/Glimepiride|1.0|||||TWO_SIDED|95.0|-2.5|4.7|||||||Miettinen \& Nurminen method was used to construct the 95% CI|4.7|-2.5|
71801409|NCT02033889|143102561|SUPERIORITY||Difference in Least Squares Means|-38.25|||<|0.001|TWO_SIDED|95.0|-44.5|-31.99|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-31.99|-44.50|<0.001
71801410|NCT02033889|143102561|SUPERIORITY||Difference in the Least Squares Means|-26.69|||<|0.001|TWO_SIDED|95.0|-32.9|-20.48|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-20.48|-32.90|<0.001
71801411|NCT02033889|143102562|SUPERIORITY||Difference in Least Squares Means|-1.6|||<|0.001|TWO_SIDED|95.0|-2.16|-1.03|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.03|-2.16|<0.001
71801412|NCT02033889|143102562|SUPERIORITY||Difference in Least Squares Means|-1.67|||<|0.001|TWO_SIDED|95.0|-2.24|-1.11|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.|-1.11|-2.24|<0.001
71801413|NCT02033889|143102563|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|4.48|||<|0.001|TWO_SIDED|95.0|2.64|7.62|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|7.62|2.64|<0.001
71840982|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-66.194||||0.1242|TWO_SIDED|95.0|-150.672|18.284|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||18.284|-150.672|0.1242
71801414|NCT02033889|143102563|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|3.03|||<|0.001|TWO_SIDED|95.0|1.81|5.06|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|5.06|1.81|<0.001
71801415|NCT02033889|143102564|SUPERIORITY||Difference in Least Squares Means|-4.5|||<|0.001|TWO_SIDED|95.0|-6.81|-2.19|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-2.19|-6.81|<0.001
71801416|NCT02033889|143102564|SUPERIORITY||Difference in Least Squares Means|-3.68||||0.002|TWO_SIDED|95.0|-5.96|-1.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-1.39|-5.96|0.002
71801417|NCT02033889|143102565|SUPERIORITY||Difference in Least Squares Means|-2.42||||0.001|TWO_SIDED|95.0|-3.86|-0.98|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.98|-3.86|0.001
71801418|NCT02033889|143102565|SUPERIORITY||Difference in Least Squares Means|-1.82||||0.013|TWO_SIDED|95.0|-3.24|-0.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.39|-3.24|0.013
71801419|NCT02033889|143102566|SUPERIORITY||Adjusted Odds Ratio|5.41|||<|0.001|TWO_SIDED|95.0|2.1|13.9|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|13.90|2.10|<0.001
71801420|NCT02033889|143102566|SUPERIORITY||Adjusted Odds Ratio|3.1||||0.023|TWO_SIDED|95.0|1.17|8.22|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.|8.22|1.17|0.023
71801421|NCT02033889|143102567|SUPERIORITY||Difference in % vs Placebo|-16.2|||<|0.001|TWO_SIDED|95.0|-22.2|-11.2|||Miettinen & Nurminen method|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-11.2|-22.2|<0.001
71801422|NCT02033889|143102567|SUPERIORITY||Difference in % vs Placebo|-14.8|||<|0.001|TWO_SIDED|95.0|-20.9|-9.4|||Miettinen & Nurminen method.|Miettinen \& Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).||||-9.4|-20.9|<0.001
71801423|NCT02033889|143102586|OTHER||Difference in the Least Squares Means|-0.1|||||TWO_SIDED|95.0|-0.71|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-0.71|
71801424|NCT02033889|143102586|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|97.0|-0.83|0.37|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.37|-0.83|
71801425|NCT02033889|143102587|OTHER||Difference in the Least Squares Means|0.7|||||TWO_SIDED|95.0|0.0|1.39|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.39|0.00|
71801426|NCT02033889|143102587|OTHER||Difference in the Least Squares Means|0.3|||||TWO_SIDED|95.0|-0.38|0.99|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.99|-0.38|
71801427|NCT02033889|143102588|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.15|0.68|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.68|-0.15|
71801428|NCT02033889|143102588|OTHER||Difference in the Least Squares Means|0.08|||||TWO_SIDED|95.0|-0.33|0.48|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.48|-0.33|
71801429|NCT02033889|143102589|OTHER||Difference in the Least Squares Means|-0.19|||||TWO_SIDED|95.0|-0.76|0.39|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.39|-0.76|
71801430|NCT02033889|143102589|OTHER||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.78|0.35|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.35|-0.78|
71801431|NCT02033889|143102593|OTHER||Difference in the Least Squares Means|0.17|||||TWO_SIDED|95.0|-0.53|0.88|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.88|-0.53|
71801432|NCT02033889|143102593|OTHER||Difference in the Least Squares Means|-0.18|||||TWO_SIDED|97.0|-0.88|0.51|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.51|-0.88|
71801433|NCT02033889|143102594|OTHER||Difference in the Least Squares Means|0.25|||||TWO_SIDED|95.0|-0.48|0.98|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.98|-0.48|
71801434|NCT02033889|143102594|OTHER||Difference in the Least Squares Means|0.2|||||TWO_SIDED|95.0|-0.51|0.91|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.91|-0.51|
71801435|NCT02033889|143102595|OTHER||Difference in the Least Squares Means|-0.5|||||TWO_SIDED|95.0|-0.95|-0.04|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.04|-0.95|
71801436|NCT02033889|143102595|OTHER||Difference in the Least Squares Means|-0.22|||||TWO_SIDED|95.0|-0.66|0.23|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.23|-0.66|
71801437|NCT02033889|143102596|OTHER||Difference in the Least Squares Means|0.06|||||TWO_SIDED|95.0|-0.61|0.72|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.72|-0.61|
71801438|NCT02033889|143102596|OTHER||Difference in the Least Squares Means|-0.15|||||TWO_SIDED|95.0|-0.78|0.49|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.78|
71801439|NCT02033889|143102600|OTHER||Difference in the Least Squares Means|-0.23|||||TWO_SIDED|95.0|-1.01|0.56|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.56|-1.01|
71801440|NCT02033889|143102600|OTHER||Difference in the Least Squares Means|-0.28|||||TWO_SIDED|97.0|-1.06|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.50|-1.06|
71801441|NCT02033889|143102601|OTHER||Difference in the Least Squares Means|0.27|||||TWO_SIDED|95.0|-0.58|1.13|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|1.13|-0.58|
71801442|NCT02033889|143102601|OTHER||Difference in the Least Squares Means|0.12|||||TWO_SIDED|95.0|-0.7|0.93|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.93|-0.70|
71801443|NCT02033889|143102602|OTHER||Difference in the Least Squares Means|-0.84|||||TWO_SIDED|95.0|-1.44|-0.24|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|-0.24|-1.44|
71801444|NCT02033889|143102602|OTHER||Difference in the least Squares Means|-0.54|||||TWO_SIDED|95.0|-1.12|0.05|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.05|-1.12|
71801445|NCT02033889|143102603|OTHER||Difference in the Least Squares Means|-0.06|||||TWO_SIDED|95.0|-0.77|0.65|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.65|-0.77|
71801446|NCT02033889|143102603|OTHER||Difference in the Least Squares Means|0.18|||||TWO_SIDED|95.0|-0.5|0.85|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.|0.85|-0.50|
71840983|NCT04800211|143191005|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-12.149||||0.8117|TWO_SIDED|95.0|-112.35|88.052|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||88.052|-112.350|0.8117
71893633|NCT01896232|143308552|NON_INFERIORITY_OR_EQUIVALENCE|Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was \< 12%, the prespecified margin for non-inferiority.|Stratified Treatment Difference|-10.48|||||TWO_SIDED|95.0|-17.45|-3.51||||||"The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region."||-3.51|-17.45|
71801447|NCT00672477|143102632|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||< 0.0001
71801448|NCT00672477|143102633|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||||||< 0.0001
71801449|NCT01176591|143102656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71801450|NCT01176591|143102657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71801451|NCT01176591|143102658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71801452|NCT01176591|143102659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||t-test, 2 sided|||||||0.039
71840984|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.957||||0.0567|TWO_SIDED|95.0|-227.151|3.237|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.237|-227.151|0.0567
71801453|NCT01176591|143102661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71801454|NCT00274716|143102663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|1.6||0.157|TWO_SIDED|95.0|-5.3|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-5.3|0.157
71801455|NCT00274716|143102663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|1.5||0.01|TWO_SIDED|95.0|-7.1|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-1.0|-7.1|0.010
71801456|NCT00274716|143102663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.6||0.042|TWO_SIDED|95.0|-6.4|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-6.4|0.042
71801457|NCT00274716|143102663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.517|TWO_SIDED|95.0|-2.1|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-2.1|0.517
71801458|NCT00274716|143102663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.602|TWO_SIDED|95.0|-3.9|2.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||2.3|-3.9|0.602
71801459|NCT00274716|143102664|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|2.4||0.046|TWO_SIDED|95.0|-9.7|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||-0.1|-9.7|0.046
71801460|NCT00274716|143102664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.108|TWO_SIDED|95.0|-8.7|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.9|-8.7|0.108
71801461|NCT00274716|143102664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.5||0.099|TWO_SIDED|95.0|-9.0|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||0.8|-9.0|0.099
71801462|NCT00274716|143102664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.5||0.752|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||4.1|-5.7|0.752
71801463|NCT00274716|143102664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.941|TWO_SIDED|95.0|-4.7|5.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable||||5.0|-4.7|0.941
71801464|NCT00274716|143102665|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.7|-2.2|<0.001
71801465|NCT00274716|143102665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.003|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-0.4|-1.9|0.003
71801466|NCT00274716|143102665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||-1.0|-2.4|<0.001
71801467|NCT00274716|143102665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.462|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.0|-0.5|0.462
71801468|NCT00274716|143102665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.4||0.118|TWO_SIDED|95.0|-0.2|1.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable||||1.3|-0.2|0.118
71893634|NCT01896232|143308553|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.001|TWO_SIDED|95.0|1.21|2.23|||Cochran-Mantel-Haenszel||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.23|1.21|0.001
71893635|NCT01896232|143308554|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.004|TWO_SIDED|95.0|1.16|2.17|||Cochran-Mantel-Haenszel||The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of \> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||2.17|1.16|0.004
71801469|NCT00274716|143102666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.059|TWO_SIDED|95.0|-3.7|0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.1|-3.7|0.059
71801470|NCT00274716|143102666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-5.5|-1.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-1.7|-5.5|<0.001
71801471|NCT00274716|143102666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.9||0.136|TWO_SIDED|95.0|-3.3|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||0.5|-3.3|0.136
71801472|NCT00274716|143102666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.686|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||1.4|-2.2|0.686
71801473|NCT00274716|143102666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.9||0.022|TWO_SIDED|95.0|-4.0|-0.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable||||-0.3|-4.0|0.022
71801474|NCT00274716|143102667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.3||0.005|TWO_SIDED|95.0|-20.8|-3.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||-3.7|-20.8|0.005
71801475|NCT00274716|143102667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|4.4||0.066|TWO_SIDED|95.0|-16.7|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.5|-16.7|0.066
71801476|NCT00274716|143102667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|4.5||0.319|TWO_SIDED|95.0|-13.4|4.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||4.4|-13.4|0.319
71801477|NCT00274716|143102667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|4.4||0.077|TWO_SIDED|95.0|-16.4|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||0.8|-16.4|0.077
71801478|NCT00274716|143102667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|4.4||0.418|TWO_SIDED|95.0|-12.2|5.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable||||5.1|-12.2|0.418
71801479|NCT00274716|143102668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|2.5||0.015|TWO_SIDED|95.0|-11.3|-1.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.2|-11.3|0.015
71801480|NCT00274716|143102668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|2.6||0.124|TWO_SIDED|95.0|-9.2|1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||1.1|-9.2|0.124
71801481|NCT00274716|143102668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.6||0.429|TWO_SIDED|95.0|-3.1|7.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||7.2|-3.1|0.429
71801482|NCT00274716|143102668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|2.5||0.001|TWO_SIDED|95.0|-13.3|-3.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-3.4|-13.3|0.001
71801483|NCT00274716|143102668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.5||0.018|TWO_SIDED|95.0|-11.1|-1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable||||-1.1|-11.1|0.018
71801484|NCT00274716|143102669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|9.0||0.587|TWO_SIDED|95.0|-12.9|22.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||22.8|-12.9|0.587
71801485|NCT00274716|143102669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|9.2||0.562|TWO_SIDED|95.0|-23.5|12.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||12.8|-23.5|0.562
71801486|NCT00274716|143102669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|9.2||0.802|TWO_SIDED|95.0|-15.8|20.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.4|-15.8|0.802
71801487|NCT00274716|143102669|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|9.0||0.772|TWO_SIDED|95.0|-15.2|20.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||20.5|-15.2|0.772
71801488|NCT00274716|143102669|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|9.2||0.409|TWO_SIDED|95.0|-25.9|10.6|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable||||10.6|-25.9|0.409
71801489|NCT01162005|143102674|SUPERIORITY_OR_OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71801490|NCT00982319|143102676|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71801491|NCT01923181|143102694|SUPERIORITY|This hypothesis was controlled for multiplicity.|Mean treatment difference|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.73|-1.22|||Mixed Models Analysis||Oral semaglutide 40 mg pooled - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.22|-1.73|<0.0001
71801492|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.4||||0.0069|TWO_SIDED|95.0|-0.69|-0.11|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.11|-0.69|0.0069
71801493|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.18|-0.6|||Mixed Models Analysis||Oral semaglutide 5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.60|-1.18|<0.0001
71801494|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.9|||Mixed Models Analysis||Oral semaglutide 10 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-0.90|-1.47|<0.0001
71801495|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.68|-1.09|||Mixed Models Analysis||Oral Semaglutide 20 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.09|-1.68|<0.0001
71801496|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.3|||Mixed Models Analysis||Oral semaglutide 40 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.30|-1.89|<0.0001
71801497|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.14|||Mixed Models Analysis||Oral semaglutide 40 mg slow dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.14|-1.72|<0.0001
71801498|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.64|-1.04|||Mixed Models Analysis||Oral semaglutide 40 mg fast dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.04|-1.64|<0.0001
71801499|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.27|||Mixed Models Analysis||Subcutaneous semaglutide 1 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||-1.27|-1.85|<0.0001
71801500|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|1.16|||<|0.0001|TWO_SIDED|95.0|0.87|1.45|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||1.45|0.87|<0.0001
71801501|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.67|||<|0.0001|TWO_SIDED|95.0|0.38|0.96|||Mixed Models Analysis||Oral semaglutide 5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.96|0.38|<0.0001
71801502|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.37||||0.0116|TWO_SIDED|95.0|0.08|0.67|||Mixed Models Analysis||Oral semaglutide 10 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.67|0.08|0.0116
71801503|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.18||||0.244|TWO_SIDED|95.0|-0.12|0.47|||Mixed Models Analysis||Oral semaglutide 20 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.47|-0.12|0.2440
71801504|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.04||||0.7973|TWO_SIDED|95.0|-0.34|0.26|||Mixed Models Analysis||Oral semaglutide 40 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.26|-0.34|0.7973
71801505|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.13||||0.3901|TWO_SIDED|95.0|-0.16|0.42|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.42|-0.16|0.3901
71801506|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.22||||0.1612|TWO_SIDED|95.0|-0.09|0.52|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.52|-0.09|0.1612
71801507|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.17||||0.2669|TWO_SIDED|95.0|-0.13|0.46|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.46|-0.13|0.2669
71801508|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.26||||0.0989|TWO_SIDED|95.0|-0.05|0.56|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.56|-0.05|0.0989
71801509|NCT01923181|143102694|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Treatment difference|0.09||||0.5565|TWO_SIDED|95.0|-0.21|0.39|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg slow-dose escalation|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.||0.39|-0.21|0.5565
71801510|NCT01863446|143102712|SUPERIORITY|Unpaired t-test comparing Lighting 1 and Lighting2||||||0.334|||||||t-test, 2 sided|||||||0.334
71801511|NCT01863446|143102712|SUPERIORITY|Unpaired t-test comparing Lighting3 vs Lighting 4||||||0.423|||||||t-test, 2 sided|||||||0.423
71801512|NCT01863446|143102713|SUPERIORITY|Unpaired t-test of Lighting1 vs Lighting2||||||0.78|||||||t-test, 2 sided|||||||0.780
71801513|NCT01863446|143102713|SUPERIORITY|Unpaired t-test of Lighting3 vs Lighting4||||||0.791|||||||t-test, 2 sided|||||||0.791
71801514|NCT01863446|143102714|SUPERIORITY|Unpaired t-test||||||0.883|||||||t-test, 2 sided|||||||0.883
71801515|NCT01863446|143102714|SUPERIORITY|Unpaired t-test||||||0.271|||||||t-test, 2 sided|||||||0.271
71801516|NCT03779997|143102720|SUPERIORITY||Risk Ratio (RR)|0.78|STANDARD_DEVIATION|0.1||0.07|TWO_SIDED|95.0|0.6|1.02||0.05 a priori threshold for statistical significance.|Log-linear GEE regression|||Null hypothesis: no difference in the percentage of urine drug tests (UDT) negative for opioids between the two treatment arms.Treatment-as-usual (TAU) is the reference group.||1.02|0.60|0.07
71801517|NCT03779997|143102721|SUPERIORITY||Risk Ratio (RR)|0.84|STANDARD_DEVIATION|0.11||0.2|TWO_SIDED|95.0|0.65|1.1||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: no difference between treatment arms in the percentage of patients engaged in treatment at week 12. TAU is the reference group.||1.10|0.65|0.20
71801518|NCT03779997|143102722|SUPERIORITY||Risk Ratio (RR)|0.73|STANDARD_DEVIATION|0.17||0.18|TWO_SIDED|95.0|0.45|1.16||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs|||Null hypothesis: No difference between arms in the percentage of participants engaged in treatment at week 24 post-randomization. TAU is the reference group.||1.16|0.45|0.18
71801519|NCT03779997|143102723|SUPERIORITY||Median Difference (Final Values)|0.9|STANDARD_DEVIATION|0.45||0.31|TWO_SIDED|95.0|-0.9|2.7||0.05 a priori threshold for statistical significance.|t-test, 2 sided||TAU is the reference group.|Null hypothesis: No difference between arms on the number of consecutive weeks with UDT negative for opioids.||2.7|-0.9|0.31
71801520|NCT03779997|143102724|SUPERIORITY||Risk Ratio (RR)|0.71|STANDARD_DEVIATION|0.41||0.57|TWO_SIDED|95.0|0.23|2.26||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in the number of participants who self-reported illicit opioid use at week 12.||2.26|0.23|0.57
71801521|NCT03779997|143102725|SUPERIORITY||Risk Ratio (RR)|1.01|STANDARD_DEVIATION|0.066||0.88|TWO_SIDED|95.0|0.89|1.15||0.05 a priori threshold for statistical significance.|GEE Poisson regression||TAU is the reference group.|Null hypothesis: No difference between arms in the mean number of days adherent to buprenorphine by self-report.||1.15|0.89|0.88
71801522|NCT03779997|143102727|SUPERIORITY||Risk Ratio (RR)|1.17|STANDARD_DEVIATION|0.6||0.77|TWO_SIDED|95.0|0.42|3.24||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who had one or more urine drug tests negative for buprenorphine.||3.24|0.42|0.77
71801523|NCT03779997|143102728|SUPERIORITY||Risk Ratio (RR)|0.67|STANDARD_DEVIATION|0.26||0.3|TWO_SIDED|95.0|0.32|1.43||0.05 a priori threshold for statistical significance.|Poisson regression with robust SEs||TAU is the reference group.|Null hypothesis: No difference between arms in number of participants who tested positive for stimulants at week 12.||1.43|0.32|0.30
71801524|NCT03779997|143102729|SUPERIORITY||Median Difference (Final Values)|0.02|STANDARD_DEVIATION|0.07||0.91|TWO_SIDED|95.0|-0.29|0.32||0.05 a priori threshold for statistical significance|t-test, 2 sided||TAU is the reference group|Null hypothesis: No difference between arms in mean treatment satisfaction scores||0.32|-0.29|0.91
71801525|NCT02312310|143102734|SUPERIORITY|Test of trend across doses.||||||0.393|||||||Mixed Models Analysis|Change in outcome from baseline to 12 weeks tested using mixed effects models controlling for baseline measures, treatment, sex, age, and education.|||The flavanol effect on the change in each outcome from baseline to 12 weeks was tested using linear mixed effects models controlling for the respective baseline measures, four categories of treatment, sex, age, and education. Regression adjusted mean within-group tests of change were estimated and tested for statistical significance from the model. The primary test used for assessing the treatment effect was the linear trend contrast from the model across: placebo, low, medium and high dose. The model for cognitive measures incorporated additional outcome measurement times at 4 weeks and 20 weeks and included categorical time (4, 12, 20 weeks) as a predictor as well as a treatment (4 category) by time interaction, and a random intercept to control for repeated measures within individuals (results for 4 and 20 weeks not presented).|||.393
71801526|NCT01168999|143102739|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
71801527|NCT01168999|143102740|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared|||||||0.01
71801528|NCT01168999|143102741|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
71893636|NCT01896232|143308555|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.15||0.27|TWO_SIDED|95.0|0.89|1.49|||Generalized Linear Mixed Model||The treatment rate ratio is Etelcalcetide : Cinacalcet.|"Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."||1.49|0.89|0.27
71893637|NCT01896232|143308556|SUPERIORITY_OR_OTHER||Treatment difference|-3.48|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.76|-2.21|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.||-2.21|-4.76|
71893638|NCT01896232|143308557|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.83|1.59|||||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.||1.59|0.83|
71801529|NCT01168999|143102742|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
71801530|NCT01168999|143102743|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Repeated Measure ANOVA|||||||0.05
71801531|NCT01168999|143102744|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Repeated Measure ANOVA|||||||>0.05
71801532|NCT00491244|143102752|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8|||<|0.001|TWO_SIDED|95.0|1.46|2.21|||Chi-squared|||||2.21|1.46|< 0.001
71801533|NCT00491244|143102753|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.61||||0.35|TWO_SIDED|95.0|0.65|4.01|||Chi-squared|||||4.01|0.65|0.35
71893639|NCT01896232|143308558|SUPERIORITY_OR_OTHER||Treatment Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.18|0.12|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.||0.12|-0.18|
71801534|NCT01276327|143102754|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.11|102.81|||Unscaled average Bioequivalence||Geometric standard error of mean was calculated.|||102.81|97.11|
71801535|NCT01276327|143102755|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|94.17|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|89.08|99.55|||Unscaled average Bioequivalence||Geometric Standard error of mean was calculated.|||99.55|89.08|
71801536|NCT01276327|143102756|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.|Adjusted gMean Ratio (Test/Ref) (%)|79.99|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|74.65|85.72|||Scaled average bioequivalence (SABE)||Geometric Standard error of mean was calculated.|||85.72|74.65|
71801537|NCT01276327|143102757|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|97.31|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|88.9|106.51|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||106.51|88.90|
71801538|NCT01276327|143102758|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|97.1|102.81|||Unscaled average bioequivalence||Geometric Standard error of mean was calculated.|||102.81|97.10|
71801539|NCT01276327|143102759|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|101.85|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|98.18|105.67|||Unscaled average bioequivalence||Geometric standard error of mean was calculated.|||105.67|98.18|
71801540|NCT01276327|143102760|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|80.79|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|75.6|86.34|||Scaled average bioequivalence (SABE)||Geometric standard error of mean was calculated.|||86.34|75.60|
71801541|NCT00807092|143102763|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.666||||95.0|-1.332|1.306||A statistical significant threshold p less than 0.025|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean IAUC(0-4hours) as covariate|BIAsp 30 - BHI 30|"The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment-Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol\*h/L"||1.306|-1.332|
71801542|NCT00807092|143102764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.178|STANDARD_ERROR_OF_MEAN|1.0||0.2412||95.0|-0.802|3.157||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Breakfast|"Null hypothesis and alternative hypothesis for breakfast:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol\*h/L"||3.157|-0.802|0.2412
71801543|NCT00807092|143102764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.318|STANDARD_ERROR_OF_MEAN|1.216||0.794||95.0|-2.724|2.087||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Lunch|"Null hypothesis and alternative hypothesis for lunch:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol\*h/L"||2.087|-2.724|0.794
71801544|NCT00807092|143102764|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.749||||0.3093||95.0|-2.2|0.703||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Dinner|"Null hypothesis and alternative hypothesis for dinner:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol\*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment-Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol\*h/L"||0.703|-2.2|0.3093
71801545|NCT00807092|143102765|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.448|STANDARD_ERROR_OF_MEAN|0.261||0.0891||95.0|-0.069|0.964||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment-Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.964|-0.069|0.0891
71801546|NCT00807092|143102767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.495|STANDARD_ERROR_OF_MEAN|0.247||0.0472||95.0|0.006|0.984||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment-Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.984|0.0060|0.0472
71801547|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.676||95.0|-0.41|0.63||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 2) value of BG as covariate|Before breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.63|-0.41|0.676
71801548|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.23||||0.026||95.0|0.15|2.31||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.31|0.15|0.026
71801549|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.5||95.0|-0.53|1.08||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.08|-0.53|0.5
71801550|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.747||95.0|-0.86|1.19||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.19|-0.86|0.747
71801551|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.581||95.0|-1.23|0.69||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.69|-1.23|0.581
71801552|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.326||95.0|-1.42|0.48||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.48|-1.42|0.326
71893640|NCT01896232|143308559|SUPERIORITY_OR_OTHER||Treatment Rate Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|0.86|1.72|||||The treatment rate ratio is Etelcalcetide : Cinacalcet.|This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.||1.72|0.86|
71801553|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19||||0.643||95.0|-0.61|0.99||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Bedtime|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.99|-0.61|0.643
71801554|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.008||95.0|0.21|1.33||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|3 AM|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.33|0.21|0.0080
71801555|NCT00807092|143102768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.274||95.0|-0.22|0.75||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Average|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment-Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.75|-0.22|0.274
71801556|NCT00807092|143102769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.062||95.0|-0.05|2.04||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Breakfast|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||2.04|-0.05|0.062
71840985|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-76.728||||0.2103|TWO_SIDED|95.0|-197.025|43.569|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.569|-197.025|0.2103
71840986|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-169.735||||0.0052|TWO_SIDED|95.0|-288.22|-51.251|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-51.251|-288.220|0.0052
71893641|NCT04425850|143308560|OTHER||||||<|0.0001|||||||Chi-squared|||Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm||||< 0.0001
71893642|NCT00686205|143308567|SUPERIORITY_OR_OTHER||Clinical Specificity|99.94||||||95.0|99.88|99.97|||Binomial Exact|Sample size is based on power of 80%, alpha level of 0.05, using the binomial distribution when comparing to a lower bound of specificity at 99.84.||||99.97|99.88|
71893643|NCT00686205|143308568|SUPERIORITY_OR_OTHER||Clinical Sensitivity|100.0||||||95.0|99.76|100.0|||Binomial Exact|||||100.00|99.76|
71893644|NCT00265941|143308569|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.88|1.32|||Log Rank||Reference arm = RT + cisplatin|A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).||1.32|0.88|0.76
71893645|NCT00265941|143308570|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.32|TWO_SIDED|95.0|0.74|1.21|||Log Rank|One-sided log-rank significance level of 0.025|Reference level = RT + cisplatin|Arms were compared using a one-sided log-rank test at the 0.025 significance level.||1.21|0.74|0.32
71893646|NCT00265941|143308571|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.97|TWO_SIDED|95.0|0.99|1.7|||Log Rank|One-sided significance level of 0.025|Reference level = RT + cisplatin|||1.70|0.99|0.97
71893647|NCT00265941|143308576|SUPERIORITY|||||||0.74|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||3 months||||0.74
71893648|NCT00265941|143308576|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||12 months||||0.99
71893649|NCT00265941|143308577|SUPERIORITY|||||||0.13|||||||Chi-squared|2-sided significance level of 0.05||Diet 3-month||||0.13
71893650|NCT00265941|143308577|SUPERIORITY|||||||0.87|||||||Chi-squared|2-sided significance level 0.05||Diet 12-month||||0.87
71893651|NCT00265941|143308577|SUPERIORITY|||||||0.39|||||||Chi-squared|2-sided significance level of 0.05||Eating 3-month||||0.39
71893652|NCT00265941|143308577|SUPERIORITY|||||||0.16|||||||Chi-squared|2-sided significance level of 0.05||Eating 12-month||||0.16
71893653|NCT00265941|143308577|SUPERIORITY|||||||0.81|||||||Chi-squared|2-sided significance level of 0.05||Speech 3-month||||0.81
71893654|NCT00265941|143308577|SUPERIORITY|||||||0.67|||||||Chi-squared|2-sided significance level of 0.05||Speech 12-month||||0.67
71893655|NCT00265941|143308578|SUPERIORITY|||||||0.016|||||||t-test, 2 sided|2-sided significance level of 0.05||||||0.016
71893656|NCT00265941|143308579|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6|TWO_SIDED|95.0|0.79|1.51|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Progression-free survival is compared between favorable risk and unfavorable risk groups.||1.51|0.79|0.60
71893657|NCT00265941|143308579|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.37|TWO_SIDED|95.0|0.81|1.76|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Overall survival is compared between favorable risk and unfavorable risk groups.||1.76|0.81|0.37
71801557|NCT00807092|143102769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.933||95.0|-1.12|1.22||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Lunch|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.22|-1.12|0.933
71801558|NCT00807092|143102769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.922||95.0|-1.16|1.05||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Dinner|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||1.05|-1.16|0.922
71893658|NCT00265941|143308579|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.76|TWO_SIDED|95.0|0.6|1.46|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Local-regional failure||1.46|0.60|0.76
71893659|NCT00265941|143308580|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.12|0.75|||Log Rank|2-sided significance level = 0.05|Reference level = low|Progression-free survival is compared between low and high SUVmax groups.||0.75|0.12|0.01
71893660|NCT00265941|143308580|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.1|TWO_SIDED|95.0|0.12|1.2|||Log Rank|2-sided significance level = 0.05|Reference level = low|Overall survival (OS) is compared between low and high SUVmax groups.||1.20|0.12|0.10
71893661|NCT00265941|143308580|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.04|TWO_SIDED|95.0|0.1|0.97|||Log Rank|2-sided significance level = 0.05|Reference level = low|Loco-regional control (LRC) is compared between low and high SUVmax groups.||0.97|0.10|0.04
71893662|NCT03090191|143308608|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|31.0|||||TWO_SIDED|96.4|-38.7|66.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||66.6|-38.7|
71893663|NCT03090191|143308609|SUPERIORITY|Lower bound of confidence interval greater than 20% demonstrate vaccine efficacy.|Vaccine efficacy|28.6|||||TWO_SIDED|96.4|-28.4|61.0|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 96.4% CI was estimated using Clopper-Pearson-Method.|||61.0|-28.4|
71893664|NCT03090191|143308618|SUPERIORITY||Vaccine efficacy|11.1|||||TWO_SIDED|98.2|-110.7|62.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model.|||62.5|-110.7|
71893665|NCT03090191|143308619|SUPERIORITY|||||||0.0172|||||||Wilcoxon Rank Sum Test (2-sided)|||||||0.0172
71893666|NCT03090191|143308620|SUPERIORITY||Ratio of proportions|0.0|||||TWO_SIDED|98.2|0.0|0.81||||||||0.81|0.00|
71893667|NCT03090191|143308621|SUPERIORITY||Vaccine efficacy|-69.3|||||TWO_SIDED|98.2|-1533.1|75.6|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of recurrent CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||75.6|-1533.1|
71893668|NCT03090191|143308622|SUPERIORITY||Vaccine efficacy|14.9|||||TWO_SIDED|98.2|-74.6|58.5|||||VE = 100\*(1 - Hazard Ratio). 98.2% CI was estimated using Proportional Means Model|||58.5|-74.6|
71893669|NCT03090191|143308623|SUPERIORITY||Vaccine efficacy|-102.4|||||TWO_SIDED|98.2|-1770.1|67.2|||||VE = 100\*(1 - IRR), where IRR= the calculated ratio of recurrent CDI incidence between the Clostridium difficile vaccine group and the placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||67.2|-1770.1|
71801559|NCT00807092|143102769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.313||95.0|-0.28|0.85||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Average|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment-Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"||0.85|-0.28|0.313
71801560|NCT00807092|143102770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.187|STANDARD_ERROR_OF_MEAN|0.371||0.6149||95.0|-0.547|0.921||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate||The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.||0.921|-0.547|0.6149
71893670|NCT03090191|143308624|SUPERIORITY||Vaccine efficacy|12.0|||||TWO_SIDED|98.2|-246.7|78.5|||||Vaccine efficacy(VE)=100\*(1-infection rate ratio\[IRR\]),IRR=calculated ratio of first primary CDI incidence between Clostridium difficile vaccine group and placebo group. 98.2% CI was estimated using Clopper-Pearson-Method.|||78.5|-246.7|
71801561|NCT00807092|143102771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.328|STANDARD_ERROR_OF_MEAN|0.577||0.5706||95.0|-0.813|1.468||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of GA as covariate||"The null hypothesis (H0) was:~H0: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment-Change in GA of BHI 30 after 6 weeks of treatment≠0 %"||1.468|-0.813|0.5706
71801562|NCT00807092|143102772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.113||0.8598||95.0|-0.243|0.243||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate||"The null hypothesis (H0) was:~H0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment-Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%"||0.243|-0.243|0.8598
71801563|NCT00807092|143102773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.054|STANDARD_ERROR_OF_MEAN|0.128||0.671||95.0|-0.307|0.198||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 3.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.198|-0.307|0.671
71801564|NCT00807092|143102773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.012|STANDARD_ERROR_OF_MEAN|0.038||0.7544||95.0|-0.088|0.064||A statistical significant threshold p\<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 2.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment-Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"||0.064|-0.088|0.7544
71801565|NCT04116229|143102775|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI restricted fraction, or putative cellularity, than people with obesity.~Null hypothesis: DBSI restricted fraction, or putative cellularity, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.05||||0.28|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.28
71801566|NCT04116229|143102775|EQUIVALENCE|"Alternative hypothesis: people with normal-weight BMI have lower DBSI hindered fraction, or putative vasogenic edema, than people with obesity.~Null hypothesis: DBSI hindered fraction, or putative vasogenic edema, is not different between normal-weight and obese groups."|Median Difference (Final Values)|0.18||||0.03|TWO_SIDED|||||a priori threshold: p \< 0.05|Independent-Samples Median Test|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.||||0.03
71801567|NCT04116229|143102776|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Crystallized cogntive function is not related to DBSI HF."|Slope|-0.69||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
71801568|NCT04116229|143102776|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative vasogenic edema (DBSI HF) in white matter tracts.~Null hypothesis: Fluid cogntive function is not related to DBSI HF."|Slope|0.52||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
71801569|NCT04116229|143102776|OTHER|"Alternative hypothesis: Worse crystallized cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Crystallized cognitive function is not related to DBSI RF."|Slope|-0.45||||0.01|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.01
71801570|NCT04116229|143102776|OTHER|"Alternative hypothesis: Worse fluid cognitive function will relate to greater putative cellularity (DBSI RF) in white matter tracts.~Null hypothesis: Fluid cognitive function is not related to DBSI RF."|Slope|0.22||||0.1|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.10
71801571|NCT04116229|143102777|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.18|||>|0.46|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.46
71801572|NCT04116229|143102777|OTHER|"Alternative hypothesis: higher levels of insulin, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Insulin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.22|||>|0.5|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||>0.5
71893671|NCT02432807|143308626|SUPERIORITY|||||||0.2219|||||||Chi-squared|||||||0.2219
71893672|NCT02432807|143308627|SUPERIORITY|||||||0.1817|||||||Chi-squared|||||||0.1817
71801573|NCT04116229|143102778|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.15||||0.62|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.62
71801574|NCT04116229|143102778|OTHER|"Alternative hypothesis: higher levels of leptin, a pro-inflammatory marker and satiety hormone, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Leptin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.07||||0.82|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.82
71801575|NCT04116229|143102779|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
71801576|NCT04116229|143102779|OTHER|"Alternative hypothesis: higher levels of ghrelin, an anti-inflammatory marker and hunger hormone, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Ghrelin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
71801577|NCT04116229|143102780|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.19||||0.53|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.53
71801578|NCT04116229|143102780|OTHER|"Alternative hypothesis: greater HOMA-IR, where higher HOMA-IR indicates greater insulin resistance, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: HOMA-IR levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.21||||0.5|TWO_SIDED||||||Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.5
71801579|NCT04116229|143102781|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.5||||0.09|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.09
71801580|NCT04116229|143102781|OTHER|"Alternative hypothesis: higher levels of IL-10, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: IL-10 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.45|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.45
71801581|NCT04116229|143102782|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.38||||0.19|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.19
71801582|NCT04116229|143102782|OTHER|"Alternative hypothesis: higher levels of adiponectin, an anti-inflammatory marker, will relate to lower levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: Adiponectin levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|-0.2||||0.52|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.52
71801583|NCT04116229|143102783|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|-0.05||||0.9|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.90
71801584|NCT04116229|143102783|OTHER|"Alternative hypothesis: higher levels of TNF-alpha, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: TNF-alpha levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.04||||0.87|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.87
71675279|NCT01908829|142868062|SUPERIORITY||Rate Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.76|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.94|0.76|=0.003
71801585|NCT04116229|143102784|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.34||||0.26|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.26
71801586|NCT04116229|143102784|OTHER|"Alternative hypothesis: higher levels of MCP-1, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: MCP-1 levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.12||||0.71|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.71
71801587|NCT04116229|143102785|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI restricted fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI RF in white matter tracts after controlling for BMI."|Slope|0.19||||0.54|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study. Analyses performed across normal-weight and obese groups.||||0.54
71801588|NCT04116229|143102785|OTHER|"Alternative hypothesis: higher levels of CRP, a pro-inflammatory marker, will relate to higher levels of putative neuroinflammation in white matter tracts as measured by DBSI hindered fraction after controlling for BMI.~Null hypothesis: CRP levels will not be related to DBSI HF in white matter tracts after controlling for BMI."|Slope|0.09||||0.77|TWO_SIDED|||||a priori threshold: p \< 0.05|Regression, Linear|||"This is a pilot study with a small sample. Power to detect significant results is therefore low in the current study.~Analyses performed across normal-weight and obese groups."||||0.77
71801589|NCT05209191|143102799|SUPERIORITY||Mean Difference (Net)|7.28|STANDARD_DEVIATION|0.65||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
71840987|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-52.505||||0.349|TWO_SIDED|95.0|-162.721|57.711|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||57.711|-162.721|0.3490
71801590|NCT05209191|143102801|SUPERIORITY||Mean Difference (Net)|0.08||||0.38|TWO_SIDED||||||t-test, 2 sided|||Paired t-test.||||.38
71801591|NCT05209191|143102802|SUPERIORITY||Chi square|52.07||||0.001|TWO_SIDED||||||Chi-squared|||||||.001
71801592|NCT01229228|143102803|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.417|STANDARD_ERROR_OF_MEAN|2.7891|<|0.001|TWO_SIDED|95.0|16.923|27.91|||ANCOVA|||||27.910|16.923|<0.001
71801593|NCT03264157|143102811|NON_INFERIORITY|The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 \> -0.1, where p is the proportion of subjects with anti-rabies titer of \>0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 \> -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.|lower 95% CI|-0.05||||0.0006|ONE_SIDED|95.0|-0.05|||The threshold for this test is \<=0.025.|Farrington and Manning test||||||-0.05|0.0006
71893673|NCT03617926|143308671|SUPERIORITY|In case superiority is not proven, non-inferiority is tested. As non-inferiority margin (δ), a 7.5% worse cure rate is regarded as clinically not relevant. The following null hypothesis will be used: H0, NI: pT-pR \< δ, whereby δ = -7.5%. The lower, 95% confidence interval of the difference pT-pR will be used for the test. If H0, NI will be rejected, non-inferiority cannot be shown.||||||0.023||||||A priori treshold p value of 0.05 for statistical significance was set prior to study start.|Chi-squared|||"Efficacy analyses is performed on the ITT population (all subjects who were included and randomized in the study, with available baseline value of the primary endpoint and at least one follow-up visit). All statistical tests are performed at a 5% level of significance. The aim of this analysis is to show superiority for the cure rate of the test product versus a predefined limit of 70%. The following null hypothesis will be tested: H0, prim: pT - pR = 0 and Ha: pT - pR \> 15%~I"||||0.023
71893674|NCT02966314|143308725|SUPERIORITY||Odds Ratio (OR)|18.7||||0.003|TWO_SIDED|95.0|2.77|126.47|||Regression, Logistic|Accounting for repeated measures||||126.47|2.77|0.003
71893675|NCT02966314|143308727|SUPERIORITY||Mean Difference (Final Values)|9.43||||0.03|TWO_SIDED|95.0|1.24|17.63|||Regression, Linear|||||17.63|1.24|0.03
71893676|NCT02966314|143308729|SUPERIORITY||Odds Ratio (OR)|32.8||||0.03|TWO_SIDED|95.0|1.49|720.54|||Regression, Logistic|Accounting for repeated measures||||720.54|1.49|0.03
71893677|NCT02966314|143308731|SUPERIORITY||Risk Ratio (RR)|6.9||||0.005|TWO_SIDED|95.0|1.9|25.3|||Regression, Linear|Accounting for multiple measures, using poisson distribution with natural log link||||25.3|1.9|0.005
71893678|NCT02015819|143308749|OTHER||||||||||||||||||MFD was determined to be 1.5x10\^8 in combination with oral 5-FC 37.5 mg/kg and leucovorin 25 mg every 6 hours for 7 days.|||
71893679|NCT01075087|143308777|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.05|TWO_SIDED|90.0|-26.0|3.0|||Wilcoxon (Mann-Whitney)|||||3|-26|.05
71801594|NCT03264157|143102812|NON_INFERIORITY|The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.|lower 95% CI|0.74|||||TWO_SIDED|95.0|0.74|0.94||||||||0.94|0.74|
71801595|NCT03264157|143102813|SUPERIORITY||95% CI|0.97|||||TWO_SIDED||||||||Data analyzed as log normal. The value presented is the untransformed value of the difference between means.|||||
71801596|NCT03264157|143102814|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|-0.05||||0.0006|TWO_SIDED|95.0|-0.05|0.1|||Farrington and Manning test|||||0.10|-0.05|0.0006
71893680|NCT00811252|143308781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.01||0.0011|TWO_SIDED|95.0|-5.31|-1.34||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.34|-5.31|0.0011
71893681|NCT00811252|143308781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-7.5|-3.46||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.46|-7.50|<0.0001
71801597|NCT03264157|143102815|NON_INFERIORITY|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|0.0||||0|TWO_SIDED|95.0|0.0|0.0|||Farrington and Manning test||For Day 14, all subjects achieved the endpoint (RVNA titer \> LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.|||0|0|0
71801598|NCT03698773|143102827|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71840988|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-11.413||||0.841|TWO_SIDED|95.0|-123.333|100.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||100.507|-123.333|0.8410
71893682|NCT00811252|143308782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|0.94||0.024|TWO_SIDED|95.0|-3.98|-0.28||Since p-value \<0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.28|-3.98|0.0240
71893683|NCT00811252|143308782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.22|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-6.1|-2.34||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-2.34|-6.10|<0.0001
71801599|NCT03698773|143102828|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71801600|NCT02822794|143102829|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.||||||<0.001
71801601|NCT02822794|143102829|SUPERIORITY||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.||||||<0.001
71801602|NCT01243944|143102865|SUPERIORITY_OR_OTHER||Odds Ratio, log|32.67|||<|0.0001|TWO_SIDED|95.0|5.04|1337.0|||Exact Cochran-Mantel-Haenszel|||||1337|5.04|< 0.0001
71801603|NCT01243944|143102866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.01|||<|0.0001|TWO_SIDED|95.0|4.24|1144.0|||Exact Cochran-Mantel-Haenszel|||||1144|4.24|<0.0001
71801604|NCT01243944|143102867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.57||||0.0016|TWO_SIDED|95.0|1.5|9.06|||Exact Cochran-Mantel-Haenszel|P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.||||9.06|1.50|0.0016
71801605|NCT04632940|143102880|OTHER||LS Mean Difference|-0.528|STANDARD_ERROR_OF_MEAN|0.8912||0.5553|TWO_SIDED|95.0|-2.308|1.251|||Mixed Models Analysis|||||1.251|-2.308|0.5553
71801606|NCT02799082|143102885|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"The percentages stated relate to the total number of subjects for the respective week and treatment.~Cochran-Mantel-Haenszel Test stratified by center"|Cochran-Mantel-Haenszel|||||||<0.0001
71801607|NCT02799082|143102886|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71801608|NCT02799082|143102894|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71801609|NCT02799082|143102895|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71801610|NCT02617589|143102934|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0037|TWO_SIDED|95.0|1.09|1.58|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.58|1.09|0.0037
71801611|NCT02617589|143102935|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.43|||||TWO_SIDED|95.0|1.19|1.71|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.71|1.19|
71840989|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-53.565||||0.3465|TWO_SIDED|95.0|-165.4|58.27|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||58.270|-165.400|0.3465
71840990|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-111.65||||0.0087|TWO_SIDED|95.0|-194.865|-28.435|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-28.435|-194.865|0.0087
71840991|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|63.944||||0.2688|TWO_SIDED|95.0|-49.678|177.565|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||177.565|-49.678|0.2688
71893684|NCT00811252|143308783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.85||0.2134|TWO_SIDED|95.0|-2.72|0.61||Since p-value \>0.05, hierarchically testing stopped here.|ANCOVA|||||0.61|-2.72|0.2134
71893685|NCT00811252|143308783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|0.86||0.0002|TWO_SIDED|95.0|-4.99|-1.6||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-1.60|-4.99|0.0002
71801612|NCT02617589|143102939|SUPERIORITY|Hazard Ratio is Nivolumab over Temozolomide|Stratified Cox proportional hazard model|1.31||||0.0024|TWO_SIDED|95.0|1.1|1.55|||Log-rank test stratified|Log-rank test stratified by complete or partial resection at baseline as entered into the IVRS.||||1.55|1.10|0.0024
71801613|NCT01591681|143102940|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.||||<0.001
71801614|NCT01591681|143102941|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||<0.001
71801615|NCT01591681|143102942|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
71801616|NCT01591681|143102943|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
71801617|NCT01591681|143102944|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
71801618|NCT01591681|143102945|SUPERIORITY_OR_OTHER|||||||0.71||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.71
71801619|NCT01591681|143102946|SUPERIORITY_OR_OTHER|||||||0.62||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.62
71801620|NCT01591681|143102947|SUPERIORITY_OR_OTHER|||||||0.1||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.||||||0.10
71801621|NCT01591681|143102948|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||<0.001
71801622|NCT01591681|143102949|SUPERIORITY_OR_OTHER|||||||0.98||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.98
71801623|NCT01591681|143102950|SUPERIORITY_OR_OTHER|||||||0.93||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||||||0.93
71801624|NCT02348489|143102963|SUPERIORITY||Difference in response rate (%)|1.92||||0.482|TWO_SIDED|96.0|-3.67|7.5|||Cochran-Mantel-Haenszel|||The complete response rate was compared between the treatment groups using a Cochran Mantel-Haenszel (CMH) test at an alpha level of 0.04 stratified to adjust for stratification factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||7.5|-3.67|0.482
71801625|NCT02348489|143102964|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.7328|TWO_SIDED|95.0|0.83|1.14|||Stratified log-rank|||Overall survival curves were estimated using Kaplan-Meier method and compared between the treatment groups using a 2-sided stratification log-rank test, stratified by the same factors used at randomization: age (\<75 or \>=75), Eastern Cooperative Oncology Group (ECOG) performance status (0-1, 2-3), study center region (North American, Europe, Rest of World), and secondary AML (secondary to MDS or other antecedent hematologic disorder) or poor-risk cytogenetics (Yes, No/Unknown).||1.14|0.83|0.7328
71801626|NCT01639001|143102972|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.402|||<|0.0001|TWO_SIDED|95.0|0.286|0.565||The study was to be considered positive if the 1-sided log-rank test for PFS, stratified for baseline stratification factors (ECOG PS, ethnicity, and brain metastases) was significant at the 0.02496level.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|The study was designed to test the null hypothesis H0: λ=1.0 versus the alternative hypothesis HA: λ \< 1.0, where λ is the hazard ratio (HR; Crizotinib/Chemotherapy). Evaluation of 160 PFS events in the 2 arms using a 1-sided log-rank test at the 0.025 level of significance was required to detect a HR of 0.64 with 80% power.||0.565|0.286|<0.0001
71801627|NCT01639001|143102973|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.869|||<|0.0001|TWO_SIDED|95.0|30.34|53.398||If the PFS endpoint was significant, ORR was to be considered significant if 2-sided p-value from Pearson chi-square test was \<= 0.04992.|2-sided pearson chi-square test||Treatment difference in ORR (%)|The confidence interval for the treatment difference was based on normal distribution.||53.398|30.340|<0.0001
71801628|NCT01639001|143102974|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.056||||0.6172|TWO_SIDED|95.0|0.734|1.521||If the PFS and ORR endpoints were significant, OS was to be considered significant if 1-sided, log-rank test stratified for ECOG, ethnicity and metastases was \<= 0.02496.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|||1.521|0.734|0.6172
71801629|NCT01639001|143102975|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|8.906||||0.1204|TWO_SIDED|95.0|-2.275|20.086|||2-sided pearson chi-square test||Treatment Difference in DCR Rate (%)|The confidence interval for the treatment difference was based on normal distribution.||20.086|-2.275|0.1204
71840992|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|151.222||||0.0096|TWO_SIDED|95.0|37.114|265.33|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||265.330|37.114|0.0096
71893686|NCT00811252|143308784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.7||0.6879|TWO_SIDED|95.0|-1.67|1.1||A nominal p-value is provided.|ANCOVA|||||1.10|-1.67|0.6879
71893687|NCT00811252|143308784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.72||0.0827|TWO_SIDED|95.0|-2.65|0.16||A nominal p-value is provided.|ANCOVA|||||0.16|-2.65|0.0827
71893688|NCT00811252|143308785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.55||0.4482|TWO_SIDED|95.0|-1.49|0.66||A nominal p-value is provided.|ANCOVA|||||0.66|-1.49|0.4482
71893689|NCT00811252|143308785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.56||0.7971|TWO_SIDED|95.0|-0.95|1.24||A nominal p-value is provided.|ANCOVA|||||1.24|-0.95|0.7971
71801630|NCT01639001|143102979|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.348|||<|0.0001|TWO_SIDED|95.0|0.246|0.493|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.493|0.246|<0.0001
71801631|NCT01639001|143102980|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.669||||0.127|TWO_SIDED|95.0|0.335|1.338|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||1.338|0.335|0.1270
71801632|NCT01639001|143102981|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.277|||<|0.0001|TWO_SIDED|95.0|0.186|0.412|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.|||0.412|0.186|<0.0001
71801633|NCT01639001|143102982|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.432|||<|0.0001|TWO_SIDED|95.0|0.307|0.61||2-sided Hochberg adjusted p-values|2 sided unstratified log rank||Based on the Cox Proportional hazards model.|||0.610|0.307|<0.0001
71801634|NCT01639001|143102983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.451|||<|0.0001|TWO_SIDED|95.0|3.79|11.11|||Mixed Models Analysis|||Analysis presented for QLQ-C30 Global QoL. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||11.11|3.79|<0.0001
71801635|NCT01639001|143102983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.613||||0.014|TWO_SIDED|95.0|0.73|6.49|||Mixed Models Analysis|||Analysis presented for QLQ-C30 cognitive functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.49|0.73|0.0140
71801636|NCT01639001|143102983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.652||||0.2427|TWO_SIDED|95.0|-1.12|4.42|||Mixed Models Analysis|||Analysis presented for QLQ-C30 emotional functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||4.42|-1.12|0.2427
71801637|NCT01639001|143102983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.7267|||<|0.0001|TWO_SIDED|95.0|4.15|9.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 physical functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||9.30|4.15|<0.0001
71801638|NCT01639001|143102983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.8109||||0.0003|TWO_SIDED|95.0|3.15|10.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 role functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.47|3.15|0.0003
71801639|NCT01639001|143102983|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.594||||0.014|TWO_SIDED|95.0|1.13|10.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 social functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||10.06|1.13|0.0140
71801640|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.0432||||0.0016|TWO_SIDED|95.0|-9.79|-2.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 appetite loss. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-2.30|-9.79|0.0016
71801641|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.5026||||0.0263|TWO_SIDED|95.0|0.53|8.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 constipation. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||8.47|0.53|0.0263
71801642|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|15.8085|||<|0.0001|TWO_SIDED|95.0|12.94|18.68|||Mixed Models Analysis|||Analysis presented for QLQ-C30 diarrhea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||18.68|12.94|<0.0001
71801643|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-7.7449|||<|0.0001|TWO_SIDED|95.0|-11.3|-4.19|||Mixed Models Analysis|||Analysis presented for QLQ-C30 dyspnea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-4.19|-11.30|<0.0001
71801644|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.4915||||0.0001|TWO_SIDED|95.0|-9.82|-3.17|||Mixed Models Analysis|||Analysis presented for QLQ-C30 fatigue. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.17|-9.82|0.0001
71801645|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.6165||||0.2099|TWO_SIDED|95.0|-9.27|2.04|||Mixed Models Analysis|||Analysis presented for QLQ-C30 financial difficulties. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.04|-9.27|0.2099
71801646|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.7756||||0.0004|TWO_SIDED|95.0|-10.49|-3.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 insomnia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.06|-10.49|0.0004
71801647|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.519||||0.0902|TWO_SIDED|95.0|-5.43|0.4|||Mixed Models Analysis|||Analysis presented for QLQ-C30 nausea and vomiting. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.40|-5.43|0.0902
71801648|NCT01639001|143102984|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.4349|||<|0.0001|TWO_SIDED|95.0|-11.42|-5.45|||Mixed Models Analysis|||Analysis presented for QLQ-C30 pain. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.45|-11.42|<0.0001
71801649|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.8547||||0.0039|TWO_SIDED|95.0|-8.15|-1.56|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 alopecia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.56|-8.15|0.0039
71801650|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.9957||||0.0004|TWO_SIDED|95.0|-10.85|-3.14|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 coughing. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-3.14|-10.85|0.0004
71801651|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.5181||||0.7082|TWO_SIDED|95.0|-3.23|2.2|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dysphagia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||2.20|-3.23|0.7082
71801652|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.6471|||<|0.0001|TWO_SIDED|95.0|-11.85|-5.44|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dyspnoea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-5.44|-11.85|<0.0001
71801653|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.2504||||0.1284|TWO_SIDED|95.0|-2.86|0.36|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 haemoptysis. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.36|-2.86|0.1284
71801654|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2363||||0.0265|TWO_SIDED|95.0|-7.98|-0.49|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in arm or shoulder. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.49|-7.98|0.0265
71801655|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.2237||||0.0185|TWO_SIDED|95.0|-7.74|-0.71|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in chest. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.71|-7.74|0.0185
71801656|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.5901||||0.0075|TWO_SIDED|95.0|-7.95|-1.23|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in other parts. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-1.23|-7.95|0.0075
71801657|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6732||||0.2848|TWO_SIDED|95.0|-4.74|1.39|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 peripheral neuropathy. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||1.39|-4.74|0.2848
71893690|NCT00811252|143308786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.29|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|-6.32|-2.26||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-2.26|-6.32|<0.0001
71893691|NCT00811252|143308787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|STANDARD_ERROR_OF_MEAN|0.74||0.0015|TWO_SIDED|95.0|-3.8|-0.91||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.91|-3.80|0.0015
71893692|NCT00811252|143308788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.32|-0.88|<0.0001
71840993|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|182.631||||0.0023|TWO_SIDED|95.0|65.754|299.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||299.509|65.754|0.0023
71840994|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-175.901||||0.1612|TWO_SIDED|95.0|-390.865|39.063|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||39.063|-390.865|0.1612
71840995|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-227.95||||0.0396|TWO_SIDED|95.0|-448.725|-7.175|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-7.175|-448.725|0.0396
71893693|NCT00811252|143308789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||-0.31|-0.82|<0.0001
71801658|NCT01639001|143102985|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.398||||0.0296|TWO_SIDED|95.0|-4.56|-0.24|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 sore mouth. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||-0.24|-4.56|0.0296
71893694|NCT00811252|143308790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.23||0.0552|TWO_SIDED|95.0|-0.88|0.01||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA|||||0.01|-0.88|0.0552
71801659|NCT01639001|143102986|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9136||||0.0123|TWO_SIDED|95.0|0.85|6.98|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D VAS subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||6.98|0.85|0.0123
71801660|NCT01639001|143102987|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0425||||0.032|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D Index score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.||0.08|0.00|0.0320
71801661|NCT01639001|143102989|SUPERIORITY_OR_OTHER_LEGACY||Overall percent agreement|0.934|||||TWO_SIDED|95.0|0.914|0.949|||||95% CI for agreement rate is calculated by the Wilson (Score) Confidence Limit method with alpha=0.05|||0.949|0.914|
71801662|NCT01639001|143102989|SUPERIORITY_OR_OTHER_LEGACY||Kappa|0.847|||||TWO_SIDED|95.0|0.8065|0.8875|||||Kappa coefficient is a statistic which measures inter-rater agreement for qualitative (categorical) items.|||0.8875|0.8065|
71893695|NCT00811252|143308791|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.0008|TWO_SIDED|95.0|0.26|0.7||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.70|0.26|0.0008
71893696|NCT00811252|143308792|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.009|TWO_SIDED|95.0|0.27|0.83||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic|||||0.83|0.27|0.0090
71893697|NCT01486264|143308794|NON_INFERIORITY|Analysis of covariance (ANCOVA) model adjusted for the baseline TWSTRS Severity subscale score, was used to test the non-inferiority of Short Flex versus Long Flex treatment. Non-inferiority margin delta equal to (=) 2 points.|Least Square (LS) Mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.9|0.1||||||||0.1|-2.9|
71893698|NCT03584009|143308837|SUPERIORITY||Risk Difference (RD)|-1.96||||0.7286|TWO_SIDED|95.0|-16.86|12.94||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||12.94|-16.86|0.7286
71893699|NCT03584009|143308838|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.7853|TWO_SIDED|95.0|0.61|1.45||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Regression, Cox|||||1.45|0.61|0.7853
71893700|NCT03584009|143308839|SUPERIORITY||Risk Difference (RD)|-1.96||||0.5978|TWO_SIDED|95.0|-12.29|8.37||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Cochran-Mantel-Haenszel|||||8.37|-12.29|0.5978
71801663|NCT01969838|143103000|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided confidence interval (CI) was calculated for the difference in splenic response rate (SRR) at Week 24: delta = prob(MMB) - 0.6\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared noninferior to RUX in SRR at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.09||||0.014|TWO_SIDED|95.0|0.02|0.16|||Cochran-Mantel-Haenszel|||||0.16|0.02|0.014
71801664|NCT01969838|143103001|NON_INFERIORITY|To evaluate the noninferiority of MMB over RUX, a conventional 2-sided CI was calculated for the difference in TSS response rate at Week 24: delta = prob(MMB) - 0.67\*prob(RUX). If the lower bound of the 2-sided 95% CI for delta was greater than 0, MMB was declared to be noninferior to RUX in TSS response rate at Week 24. The 2-sided 95% CI of delta was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions. This is called the noninferiority proportion difference.|Proportion Difference - Stratified CMH|0.0||||0.98|TWO_SIDED|95.0|-0.08|0.08|||Cochran-Mantel-Haenszel|||||0.08|-0.08|0.98
71801665|NCT01969838|143103002|SUPERIORITY||Rate ratio|0.28|||<|0.001|TWO_SIDED|95.0|0.19|0.43|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||0.43|0.19|<0.001
71801666|NCT01969838|143103003|SUPERIORITY||Proportion Difference - Stratified CMH|0.18|||<|0.001|TWO_SIDED|95.0|0.09|0.26|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.26|0.09|<0.001
71801667|NCT01969838|143103004|SUPERIORITY||Proportion Difference - Stratified CMH|-0.1||||0.019|TWO_SIDED|95.0|-0.19|-0.02|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||-0.02|-0.19|0.019
71801668|NCT00408993|143103021|SUPERIORITY_OR_OTHER|||||||0.617||95.0||||Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.|ANCOVA|Model=Treatment, Pooled Investigator and Baseline.||With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.||||0.617
71801669|NCT00408993|143103022|SUPERIORITY_OR_OTHER|||||||0.07||95.0||||P-value for Worst Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.070
71801670|NCT00408993|143103022|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||P-value for Least Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.151
71801671|NCT00408993|143103022|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||P-value for Pain Right Now Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.012
71801672|NCT00408993|143103022|SUPERIORITY_OR_OTHER|||||||0.077||95.0||||P-value for Average Interference Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.077
71801673|NCT00408993|143103023|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.036
71801674|NCT00408993|143103024|SUPERIORITY_OR_OTHER|||||||0.955||95.0||||P-value for Visit 3|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.955
71801675|NCT00408993|143103024|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Visit 4|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.004
71893701|NCT03584009|143308841|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.0403|TWO_SIDED|95.0|1.02|3.43||P-value is based on Stratified Analysis (Stratified by BCL2 status (High vs Low) and Lines of Therapy (2 vs 1)).|Log Rank||Hazard ratios were estimated by Cox regression.|||3.43|1.02|0.0403
71801676|NCT00408993|143103024|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Visit 5|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.037
71801677|NCT00408993|143103024|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Visit 6|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||<0.001
71801678|NCT00408993|143103024|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Visit 7|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment\*Visit and Baseline\*Visit.||||||0.028
71801679|NCT00408993|143103025|SUPERIORITY_OR_OTHER|||||||0.207||95.0|||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.207
71801680|NCT00408993|143103026|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
71893702|NCT04871815|143308895|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Body Aches||||0.200
71893703|NCT04871815|143308895|SUPERIORITY|||||||0.0326|||||||Wilcoxon (Mann-Whitney)|||Headaches||||0.0326
71893704|NCT04871815|143308895|SUPERIORITY|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||Coughing/Sneezing||||0.0043
71801681|NCT00408993|143103028|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value for 5-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.364
71801682|NCT00408993|143103028|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value for 8-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.||||||0.590
71801683|NCT00408993|143103029|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.620
71801684|NCT00408993|143103030|SUPERIORITY_OR_OTHER|||||||0.324||95.0|||||ANOVA|Model=Treatment and Pooled Investigator||||||0.324
71801685|NCT00408993|143103031|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||P-value for Systolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.642
71801686|NCT00408993|143103031|SUPERIORITY_OR_OTHER|||||||0.601||95.0||||P-value for Diastolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator||||||0.601
71893705|NCT04871815|143308895|SUPERIORITY|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Trouble Breathing||||0.0003
71801687|NCT00408993|143103032|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Chloride|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.014
71801688|NCT00408993|143103032|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for High Density Lipoprotein Cholesterol|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.005
71801689|NCT00408993|143103032|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Sodium|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.011
71801690|NCT00408993|143103032|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||P-value for triglycerides|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.||||||0.044
71801691|NCT00408993|143103033|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.||||||0.017
71801692|NCT01694706|143103046|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|120.35|STANDARD_DEVIATION|23.2||0.342|TWO_SIDED|90.0|102.09|141.88|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||141.88|102.09|0.3420
71801693|NCT01694706|143103046|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.33|STANDARD_DEVIATION|30.8||0.0962|TWO_SIDED|90.0|76.21|116.76|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||116.76|76.21|0.0962
71801694|NCT01694706|143103047|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|118.79|STANDARD_DEVIATION|52.4||0.3993|TWO_SIDED|90.0|83.19|169.628|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||169.628|83.190|0.3993
71801695|NCT01694706|143103047|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|93.55|STANDARD_DEVIATION|53.0||0.2204|TWO_SIDED|90.0|65.783|133.03|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||133.030|65.783|0.2204
71801696|NCT01694706|143103048|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|121.28|STANDARD_DEVIATION|24.0||0.3765|TWO_SIDED|90.0|102.32|143.74|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||143.74|102.32|0.3765
71801697|NCT01694706|143103048|NON_INFERIORITY_OR_EQUIVALENCE|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.72|STANDARD_DEVIATION|31.4||0.0946|TWO_SIDED|90.0|76.25|117.67|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)|||117.67|76.25|0.0946
71801698|NCT02057757|143103049|EQUIVALENCE|The equivalence margin is 1.25 Days.||||||0.5634|||||||Fay - Shaw|||||||0.5634
71801699|NCT02057757|143103050|SUPERIORITY|||||||0.645||||||The p-value for each time point was calculated; Day 3|Fay - Shaw|||||||0.645
71801700|NCT02057757|143103050|SUPERIORITY|||||||0.989||||||The p-value for each value was calculated (Day 7).|Fay-Shaw|||||||0.989
71801701|NCT02057757|143103050|SUPERIORITY|||||||0.809||||||Day 14|Fay-Shaw|||||||0.809
71801702|NCT02057757|143103050|SUPERIORITY|||||||0.671||||||Day 28|Fay-Shaw|||||||0.671
71801703|NCT02057757|143103052|SUPERIORITY|||||||0.4277||||||Cough|Fay - Shaw|||||||0.4277
71801704|NCT02057757|143103052|SUPERIORITY|||||||0.4022||||||Sore Throat|Fay-Shaw|||||||0.4022
71801705|NCT02057757|143103052|SUPERIORITY|||||||0.5957||||||Fatigue|Fay-Shaw|||||||0.5957
71801706|NCT02057757|143103052|SUPERIORITY|||||||0.0446||||||Nasal Discharge|Fay-Shaw|||||||0.0446
71801707|NCT02057757|143103052|SUPERIORITY|||||||0.8628||||||Difficulty Breathing|Fay-Shaw|||||||0.8628
71801708|NCT02057757|143103052|SUPERIORITY|||||||0.16||||||Headache|Fay-Shaw|||||||0.16
71801709|NCT02057757|143103052|SUPERIORITY|||||||0.1234||||||Muscle Pain|Fay-Shaw|||||||0.1234
71801710|NCT02057757|143103052|SUPERIORITY|||||||0.2155||||||Nausea|Fay-Shaw|||||||0.2155
71801711|NCT02057757|143103052|SUPERIORITY|||||||0.5176||||||Vomiting|Fay-Shaw|||||||0.5176
71801712|NCT02057757|143103052|SUPERIORITY|||||||0.6986||||||Diarrhea|Fay-Shaw|||||||0.6986
71801713|NCT02057757|143103053|SUPERIORITY|||||||0.985|||||||Fay - Shaw|||||||0.9850
71801714|NCT02057757|143103054|SUPERIORITY|||||||0.681||||||Any Time|Fay - Shaw|||||||0.681
71801715|NCT02057757|143103054|SUPERIORITY|||||||0.341||||||Day 0|Fay-Shaw|||||||0.341
71801716|NCT02057757|143103054|SUPERIORITY|||||||0.321||||||Day 3|Fay-Shaw|||||||0.321
71801717|NCT02057757|143103054|SUPERIORITY|||||||0.957||||||Day 7|Fay-Shaw|||||||0.957
71801718|NCT02057757|143103054|SUPERIORITY|||||||0.788||||||Day 14|Fay-Shaw|||||||0.788
71801719|NCT02057757|143103054|SUPERIORITY|||||||0.544||||||Day 28|Fay-Shaw|||||||0.544
71801720|NCT02057757|143103055|SUPERIORITY|||||||0.671||||||Any Time|Fay - Shaw|||||||0.671
71801721|NCT02057757|143103055|SUPERIORITY|||||||0.325||||||Day 0|Fay-Shaw|||||||0.325
71801722|NCT02057757|143103055|SUPERIORITY|||||||0.987||||||Day 3|Fay-Shaw|||||||0.987
71801723|NCT02057757|143103055|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
71801724|NCT02057757|143103055|SUPERIORITY|||||||0.311||||||Day 14|Fay-Shaw|||||||0.311
71801725|NCT02057757|143103056|SUPERIORITY|||||||0.973||||||Any Time|Fay - Shaw|||||||0.973
71801726|NCT02057757|143103056|SUPERIORITY|||||||0.575||||||Day 0|Fay-Shaw|||||||0.575
71801727|NCT02057757|143103056|SUPERIORITY|||||||0.548||||||Day 3|Fay-Shaw|||||||0.548
71801728|NCT02057757|143103056|SUPERIORITY|||||||0.987||||||Day 7|Fay-Shaw|||||||0.987
71801729|NCT02057757|143103056|SUPERIORITY|||||||0.987||||||Day 14|Fay-Shaw|||||||0.987
71801730|NCT02057757|143103056|SUPERIORITY|||||||0.987||||||Day 28|Fay-Shaw|||||||0.987
71801731|NCT02057757|143103057|SUPERIORITY|||||||0.928||||||Pneumonia|Fay - Shaw|||||||0.928
71801732|NCT02057757|143103057|SUPERIORITY|||||||0.9669||||||ARDS|Fay-Shaw|||||||0.9669
71801733|NCT02057757|143103057|SUPERIORITY|||||||0.0832||||||Bronchitis|Fay-Shaw|||||||0.0832
71801734|NCT02057757|143103058|SUPERIORITY|||||||0.036||||||Adults (\>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?|Fay - Shaw|||||||0.0360
71801735|NCT02057757|143103058|SUPERIORITY|||||||0.038||||||Adults (\>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?|Fay-Shaw|||||||0.0380
71801736|NCT02057757|143103058|SUPERIORITY|||||||0.5035||||||Children (\< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?|Fay-Shaw|||||||0.5035
71801737|NCT02057757|143103058|SUPERIORITY|||||||0.9231||||||Children (\<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?|Fay-Shaw|||||||0.9231
71801738|NCT02057757|143103062|SUPERIORITY|||||||0.9785||||||No Detectable Virus on Day 3|Fay-Shaw|||||||0.9785
71801739|NCT00456092|143103099|SUPERIORITY||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.72|10.2||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||10.20|1.72|0.002
71801740|NCT00456092|143103099|SUPERIORITY||Odds Ratio (OR)|5.77|||<|0.001|TWO_SIDED|95.0|2.4|13.88||A p-value \< 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected|||||13.88|2.40|< 0.001
71801741|NCT00456092|143103102|SUPERIORITY||Odds Ratio (OR)|5.12||||0.056|TWO_SIDED|95.0|1.06|24.67|||Chi-squared, Corrected|||||24.67|1.06|0.056
71801742|NCT00456092|143103102|SUPERIORITY||Odds Ratio (OR)|6.95||||0.012|TWO_SIDED|95.0|1.49|32.35|||Chi-squared, Corrected|||||32.35|1.49|0.012
71801743|NCT00456092|143103103|SUPERIORITY||Odds Ratio (OR)|5.4||||0.204|TWO_SIDED|95.0|0.61|47.54|||Chi-squared, Corrected|||||47.54|0.61|0.204
71801744|NCT00456092|143103103|SUPERIORITY||Odds Ratio (OR)|4.12||||0.371|TWO_SIDED|95.0|0.45|37.88|||Chi-squared, Corrected|||||37.88|0.45|0.371
71801745|NCT00456092|143103104|SUPERIORITY||Odds Ratio (OR)|1.568||||0.264|TWO_SIDED|95.0|0.79|3.11|||Chi-squared, Corrected|||||3.11|0.79|0.264
71801746|NCT00456092|143103104|SUPERIORITY||Odds Ratio (OR)|1.98||||0.071|TWO_SIDED|95.0|1.0|3.91|||Chi-squared, Corrected|||||3.91|1.00|0.071
71801747|NCT00456092|143103105|SUPERIORITY||Odds Ratio (OR)|1.305||||0.549|TWO_SIDED|95.0|0.66|2.57|||Chi-squared, Corrected|||||2.57|0.66|0.549
71801748|NCT00456092|143103105|SUPERIORITY||Odds Ratio (OR)|1.033||||1|TWO_SIDED|95.0|0.53|2.03|||Chi-squared, Corrected|||||2.03|0.53|1.000
71801749|NCT00456092|143103106|SUPERIORITY||Odds Ratio (OR)|2.06||||0.083|TWO_SIDED|95.0|0.98|4.34|||Chi-squared, Corrected|||||4.34|0.98|0.083
71801750|NCT00456092|143103106|SUPERIORITY||Odds Ratio (OR)|1.63||||0.279|TWO_SIDED|95.0|0.77|3.44|||Chi-squared, Corrected|||||3.44|0.77|0.279
71801751|NCT00456092|143103107|SUPERIORITY||Odds Ratio (OR)|1.32||||0.548|TWO_SIDED|95.0|0.66|2.66|||Chi-squared, Corrected|||||2.66|0.66|0.548
71801752|NCT00456092|143103107|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.52|2.11|||Chi-squared, Corrected|||||2.11|0.52|1.000
71801753|NCT00456092|143103110|SUPERIORITY||Treatment Difference|11.58||||0.136|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.136
71801754|NCT00456092|143103110|SUPERIORITY||Treatment Difference|13.53||||0.08|TWO_SIDED||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo|||||0.080
71801755|NCT00456092|143103111|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.745|1.211|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||1.211|0.745|0.650
71801756|NCT00456092|143103111|SUPERIORITY||Hazard Ratio (HR)|1.265||||0.283|TWO_SIDED|95.0|0.791|2.024|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.024|0.791|0.283
71801757|NCT00456092|143103112|SUPERIORITY||Hazard Ratio (HR)|1.337||||0.253|TWO_SIDED|95.0|0.791|2.26|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.260|0.791|0.253
71801758|NCT00456092|143103112|SUPERIORITY||Hazard Ratio (HR)|3.023||||0.026|TWO_SIDED|95.0|1.059|8.63|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||8.630|1.059|0.026
71801759|NCT00456092|143103113|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.984|TWO_SIDED|95.0|0.457|2.215|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||2.215|0.457|0.984
71801760|NCT00456092|143103113|SUPERIORITY||Hazard Ratio (HR)|0.872||||0.836|TWO_SIDED|95.0|0.158|4.797|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.|||4.797|0.158|0.836
71801761|NCT00456092|143103118|SUPERIORITY||Adjusted Mean Difference|1.4||||0.308|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.308
71801762|NCT00456092|143103118|SUPERIORITY||Adjusted Mean Difference|4.1||||0.003|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component||||0.003
71801763|NCT00456092|143103118|SUPERIORITY||Adjusted Mean Difference|1.6||||0.182|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.182
71801764|NCT00456092|143103118|SUPERIORITY||Adjusted Mean Difference|2.7||||0.026|TWO_SIDED||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component||||0.026
71801765|NCT00456092|143103119|SUPERIORITY||Adjusted Mean Difference|-2.1||||0.016|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.016
71801766|NCT00456092|143103119|SUPERIORITY||Adjusted Mean Difference|-1.4||||0.105|TWO_SIDED||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.105
71801767|NCT00456092|143103121|SUPERIORITY||Adjusted Mean Difference|3.3||||0.028|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.028
71801768|NCT00456092|143103121|SUPERIORITY||Adjusted Mean Difference|4.3||||0.004|TWO_SIDED||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.|||||0.004
71801769|NCT00563797|143103141|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED|||||F=7.73|Mixed Models Analysis|||Comparison is between baseline and during treatment.||||0.014
71801770|NCT00563797|143103142|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||F=36.32|Mixed Models Analysis|||Comparison of baseline and post-treatment||||.0001
71801771|NCT00563797|143103143|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Mixed Models Analysis|||||||.025
71801772|NCT00563797|143103144|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Mixed Models Analysis|||||||.019
71801773|NCT00659269|143103148|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
71801774|NCT02443298|143103152|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0255|TWO_SIDED|80.0|1.18|1.81|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.81|1.18|0.0255
71801775|NCT02443298|143103153|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.0131|TWO_SIDED|80.0|1.2|1.79|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.||1.79|1.20|0.0131
71801776|NCT02443298|143103154|SUPERIORITY||Rate Ratio|1.4937|STANDARD_ERROR_OF_MEAN|0.22||0.0065|TWO_SIDED|80.0|1.2366|1.8044|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.8044|1.2366|0.0065
71801777|NCT02443298|143103155|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4619|TWO_SIDED|80.0|0.88|1.57|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|Time to first event is obtained from fitting a Cox proportional-hazards model including treatment, and OCS use at baseline as covariate||1.57|0.88|0.4619
71801778|NCT02443298|143103156|SUPERIORITY||Rate Ratio|1.1317|STANDARD_ERROR_OF_MEAN|0.237||0.555|TWO_SIDED|80.0|0.8652|1.4803|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.||1.4803|0.8652|0.5550
71801779|NCT02443298|143103157|SUPERIORITY||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.051||0.4423|TWO_SIDED|80.0|-0.104|0.026|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||0.026|-0.104|0.4423
71801780|NCT02443298|143103158|SUPERIORITY||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.045||0.1377|TWO_SIDED|80.0|-0.126|-0.009|||Mixed Models Analysis|Unstructured covariance structure for within-patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment-by-test day interaction, baseline, and baseline-by-test day interaction as covariates patient as a random effect.||-0.009|-0.126|0.1377
71801781|NCT02443298|143103159|SUPERIORITY||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.115||0.1985|TWO_SIDED|80.0|0.0|0.297|||ANCOVA||Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.||0.297|0.000|0.1985
71801782|NCT01047683|143103178|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.1|||<|0.0001|TWO_SIDED|95.0|-46.6|-21.5||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.01 for the primary endpoint.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|A standard deviation of 45% in the TG measurements and a significance level of P \< 0.01 required a sample size of 69 completed patients per treatment group to provide greater than or equal to 90% power to detect a difference of 30% between AMR101 and placebo in the percentage of change from baseline in the fasting TG levels.||-21.5|-46.6|<0.0001
71801783|NCT01047683|143103178|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.7||||0.0051|TWO_SIDED|95.0|-33.3|-5.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-5.6|-33.3|0.0051
71801784|NCT01047683|143103179|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-28.6||||0.0005|TWO_SIDED|95.0|-43.4|-13.9||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05 for secondary and exploratory endpoints.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-13.9|-43.4|0.0005
71801785|NCT01047683|143103179|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-15.3||||0.1152|TWO_SIDED|95.0|-30.3|-0.7|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-0.7|-30.3|0.1152
71801786|NCT01047683|143103180|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-13.6||||0.0006|TWO_SIDED|95.0|-20.2|-6.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-6.3|-20.2|0.0006
71893706|NCT04871815|143308895|SUPERIORITY|||||||0.3714|||||||Wilcoxon (Mann-Whitney)|||Congestion||||0.3714
71801787|NCT01047683|143103180|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-5.1||||0.2367|TWO_SIDED|95.0|-12.3|2.2|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||2.2|-12.3|0.2367
71801788|NCT01047683|143103181|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.5||||0.0019|TWO_SIDED|95.0|-13.5|-3.2||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-3.2|-13.5|0.0019
71801789|NCT01047683|143103181|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.6||||0.2367|TWO_SIDED|95.0|-7.8|1.9|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||1.9|-7.8|0.2367
71801790|NCT01047683|143103182|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.3||||0.6768|TWO_SIDED|95.0|-12.9|8.1||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||8.1|-12.9|0.6768
71801791|NCT01047683|143103182|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|5.2||||0.3022|TWO_SIDED|95.0|-5.4|15.6|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||15.6|-5.4|0.3022
71801792|NCT01047683|143103183|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-17.7|||<|0.0001|TWO_SIDED|95.0|-25.0|-11.3||Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.|Wilcoxon rank-sum test|A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.|Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-11.3|-25.0|<0.0001
71801793|NCT01047683|143103183|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.1||||0.0182|TWO_SIDED|95.0|-15.1|-1.4|||Wilcoxon rank-sum test||Median differences between the treatment groups and 95% CIs were estimated with the Hodges-Lehmann method.|||-1.4|-15.1|0.0182
71801794|NCT00908960|143103185|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.7||||0.06|TWO_SIDED|95.0|1.03|43.17|||Fine and Gray regression|||||43.17|1.03|0.06
71801795|NCT05074433|143103188|SUPERIORITY||Hazard Ratio (HR)|0.563|||||TWO_SIDED|95.0|0.093|3.393|||Cox proportional hazard model|||||3.393|0.093|
71801796|NCT05074433|143103188|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.072|2.929|||Cox proportional hazard model|||||2.929|0.072|
71801797|NCT05074433|143103188|SUPERIORITY||Cox Proportional Hazard|0.609|||||TWO_SIDED|95.0|0.101|3.668|||Cox proportional hazard model|||||3.668|0.101|
71801798|NCT02248922|143103234|OTHER|||||||0.4099|||||||ANOVA|||||||0.4099
71801799|NCT02248922|143103235|OTHER|||||||0.6961|||||||ANOVA|||||||0.6961
71893707|NCT04871815|143308895|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fatigue||||0.300
71801800|NCT02248922|143103236|OTHER|||||||0.354|||||||ANOVA|||||||0.3540
71801801|NCT02248922|143103237|OTHER|||||||0.591|||||||ANOVA|||||||0.5910
71801802|NCT02248922|143103238|OTHER|||||||0.4249|||||||ANOVA|||||||0.4249
71801803|NCT02248922|143103239|OTHER|||||||0.3963|||||||ANOVA|||||||0.3963
71801804|NCT02248922|143103240|OTHER|||||||0.3502|||||||ANOVA|||||||0.3502
71801805|NCT02480621|143103246|SUPERIORITY||Mean Difference (Net)|1.74|||<|0.1|TWO_SIDED||||||t-test, 2 sided|||||||<0.10
71801806|NCT03056690|143103247|SUPERIORITY|Mixed model repeated measures (MMRM) analysis model is performed with change from baseline (Week 8) as response; treatment, center (pooled where necessary), time (week 8) and treatment\*time as fixed effects, baseline and baseline\*time as covariates.|LSMean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.25||0.086|TWO_SIDED|90.0|-0.76|0.07|||MMRM|||||0.07|-0.76|0.086
71801807|NCT03056690|143103253|SUPERIORITY||Difference|0.2||||0.551|TWO_SIDED|90.0|-11.9|12.5|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||12.5|-11.9|0.551
71801808|NCT03056690|143103254|SUPERIORITY||Difference|6.9||||0.202|TWO_SIDED|90.0|-5.2|19.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||19.1|-5.2|0.202
71801809|NCT03056690|143103255|SUPERIORITY||Difference|1.7||||0.451|TWO_SIDED|90.0|-10.5|13.8|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||13.8|-10.5|0.451
71801810|NCT03056690|143103256|SUPERIORITY||Difference|6.1||||0.174|TWO_SIDED|90.0|-6.2|18.1|||Fisher Exact|CI for each treatment group and the difference of the proportions is an exact unconditional confidence interval based on Santner-Snell approach.||||18.1|-6.2|0.174
71801811|NCT03056690|143103257|SUPERIORITY||Least Square (LS) Mean difference|-1.48|STANDARD_ERROR_OF_MEAN|2.04||0.235|TWO_SIDED|90.0|-4.86|1.9||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 2||1.90|-4.86|0.235
71801812|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-2.97|STANDARD_ERROR_OF_MEAN|2.34||0.103|TWO_SIDED|90.0|-6.84|0.89||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 4||0.89|-6.84|0.103
71801813|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-2.59|STANDARD_ERROR_OF_MEAN|2.53||0.154|TWO_SIDED|90.0|-6.78|1.6||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Function Subscale: Week 8||1.60|-6.78|0.154
71893708|NCT04871815|143308895|SUPERIORITY|||||||0.2286|||||||Wilcoxon (Mann-Whitney)|||Loss of Smell/Taste||||0.2286
71801814|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|1.88||0.238|TWO_SIDED|90.0|-4.45|1.77||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 2||1.77|-4.45|0.238
71801815|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-3.73|STANDARD_ERROR_OF_MEAN|2.11||0.039|TWO_SIDED|90.0|-7.22|-0.24||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 4||-0.24|-7.22|0.039
71801816|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-3.06|STANDARD_ERROR_OF_MEAN|2.34||0.097|TWO_SIDED|90.0|-6.93|0.81||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Symptoms Subscale: Week 8||0.81|-6.93|0.097
71801817|NCT03056690|143103257|SUPERIORITY||LSMean DIfference|-0.99|STANDARD_ERROR_OF_MEAN|0.63||0.057|TWO_SIDED|90.0|-2.03|0.04||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 2||0.04|-2.03|0.057
71801818|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.63||0.018|TWO_SIDED|90.0|-2.39|-0.29||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 4||-0.29|-2.39|0.018
71801819|NCT03056690|143103257|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.7||0.111|TWO_SIDED|90.0|-2.02|0.3||MMRM analysis model is performed with change from baseline (Weeks 2, 4, and 8) as response; treatment, center (pooled where necessary), time (Weeks 2, 4 and 8), treatment\*time as fixed effects, baseline and baseline\*time as covariates.|MMRM|||Overall Impact Subscale: Week 8||0.30|-2.02|0.111
71801820|NCT03056690|143103258|SUPERIORITY||LSMean difference|-3.15|STANDARD_ERROR_OF_MEAN|2.36||0.092|TWO_SIDED|90.0|-7.05|0.75||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Function Subscale||0.75|-7.05|0.092
71840996|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-352.366||||0.0002|TWO_SIDED|95.0|-573.315|-131.418|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-131.418|-573.315|0.0002
71801821|NCT03056690|143103258|SUPERIORITY||LSMean difference|-3.29|STANDARD_ERROR_OF_MEAN|2.16||0.065|TWO_SIDED|90.0|-6.85|0.28||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Symptoms subscale||0.28|-6.85|0.065
71801822|NCT03056690|143103258|SUPERIORITY||LSMean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.65||0.049|TWO_SIDED|90.0|-2.15|-0.01||ANCOVA model is performed with change from baseline at the EOT timepoint as response treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|ANCOVA|||Overall Impact Subscale.||-0.01|-2.15|0.049
71801823|NCT03056690|143103259|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Odds Ratio (OR)|1.43||||0.192|TWO_SIDED|90.0|0.91|2.24|||Likelihood test|||Week 2||2.24|0.91|0.192
71801824|NCT03056690|143103259|SUPERIORITY||Odds Ratio (OR)|1.33||||0.285|TWO_SIDED|90.0|0.86|2.07||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihod test|||Week 4||2.07|0.86|0.285
71893709|NCT04871815|143308895|SUPERIORITY|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||Anxiety||||0.999
71801825|NCT03056690|143103259|SUPERIORITY||Odds Ratio (OR)|1.2||||0.486|TWO_SIDED|90.0|0.78|1.87||The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test. p-value is for the comparison of ASP0819 15 mg with Placebo from the above described proportional odds model.|Likelihood test|||EOT||1.87|0.78|0.486
71801826|NCT03056690|143103260|SUPERIORITY|The 90% 2-sided CI is based on profile likelihood and 2-sided p-value is based on likelihood test.|Odds Ratio (OR)|1.32||||0.305|TWO_SIDED|90.0|0.85|2.05|||Likelihood test|||Week 8||2.05|0.85|0.305
71893710|NCT04871815|143308896|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71893711|NCT04871815|143308897|SUPERIORITY|||||||0.1963|||||||ANOVA|||||||0.1963
71893712|NCT04871815|143308898|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71801827|NCT02442700|143103271|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71801828|NCT00752908|143103273|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71801829|NCT00153101|143103275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8462||95.0|0.92|1.07|||Regression, Cox|||||1.07|0.92|0.8462
71801830|NCT00153101|143103275|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|1.01||||0.0019||97.5|0.93|1.1|||Regression, Cox|||||1.10|0.93|0.0019
71801831|NCT00153101|143103276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9086||95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.9086
71801832|NCT00153101|143103276|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin was 1.13|Hazard Ratio (HR)|0.99||||0.0004||97.5|0.9|1.08|||Regression, Cox|||||1.08|0.90|0.0004
71801833|NCT00153101|143103277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.4535||95.0|0.93|1.17|||Regression, Cox|||||1.17|0.93|0.4535
71801834|NCT00153101|143103277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9421||95.0|0.89|1.12|||Regression, Cox|||||1.12|0.89|0.9421
71801835|NCT00153101|143103278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2909||95.0|0.94|1.23|||Regression, Cox|||||1.23|0.94|0.2909
71801836|NCT00153101|143103278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2534||95.0|0.94|1.24|||Regression, Cox|||||1.24|0.94|0.2534
71801837|NCT00153101|143103279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2248||95.0|0.79|1.06|||Regression, Cox|||||1.06|0.79|0.2248
71801838|NCT00153101|143103279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.1829||95.0|0.79|1.05|||Regression, Cox|||||1.05|0.79|0.1829
71801839|NCT00153101|143103280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4984||95.0|0.82|1.1|||Regression, Cox|||||1.10|0.82|0.4984
71801840|NCT00153101|143103280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.1203||95.0|0.97|1.29|||Regression, Cox|||||1.29|0.97|0.1203
71801841|NCT00153101|143103281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.4221|TWO_SIDED|95.0|0.73|2.15|||Regression, Cox|||||2.15|0.73|0.4221
71675280|NCT01908829|142868062|SUPERIORITY||Rate Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.63|0.86||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.86|0.63|<0.001
71893713|NCT04871815|143308898|SUPERIORITY|||||||0.0008||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 1 treatment (day 7 of study).||||0.0008
71801842|NCT00153101|143103281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.7305||95.0|0.51|1.6|||Regression, Cox|||||1.60|0.51|0.7305
71801843|NCT00153101|143103282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.6248||95.0|0.54|1.45|||Regression, Cox|||||1.45|0.54|0.6248
71801844|NCT00153101|143103282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0751|TWO_SIDED|95.0|0.36|1.05|||Regression, Cox|||||1.05|0.36|0.0751
71801845|NCT00153101|143103283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.3682||95.0|0.63|1.18|||Regression, Cox|||||1.18|0.63|0.3682
71801846|NCT00153101|143103283|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.6014||95.0|0.69|1.24|||Regression, Cox|||||1.24|0.69|0.6014
71801847|NCT00153101|143103284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.255||95.0|0.91|1.42|||Regression, Cox|||||1.42|0.91|0.2550
71801848|NCT00153101|143103284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.5297||95.0|0.86|1.34|||Regression, Cox|||||1.34|0.86|0.5297
71801849|NCT00153101|143103285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.4593||95.0|0.82|1.56|||Regression, Cox|||||1.56|0.82|0.4593
71801850|NCT00153101|143103285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.7468||95.0|0.68|1.32|||Regression, Cox|||||1.32|0.68|0.7468
71801851|NCT00153101|143103286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.5461|TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|0.5461
71801852|NCT00153101|143103286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.3436||95.0|0.68|1.14|||Regression, Cox|||||1.14|0.68|0.3436
71801853|NCT00153101|143103287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0133||95.0|0.8|0.97|||Regression, Cox|||||0.97|0.80|0.0133
71801854|NCT00153101|143103287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.1251||95.0|0.84|1.02|||Regression, Cox|||||1.02|0.84|0.1251
71801855|NCT00153101|143103288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0213||95.0|0.67|0.97|||Regression, Cox|||||0.97|0.67|0.0213
71801856|NCT00153101|143103288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2396||95.0|0.75|1.07|||Regression, Cox|||||1.07|0.75|0.2396
71801857|NCT00153101|143103289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0111||95.0|0.83|0.98|||Regression, Cox|||||0.98|0.83|0.0111
71801858|NCT00153101|143103289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.0606||95.0|0.85|1.0|||Regression, Cox|||||1.00|0.85|0.0606
71801859|NCT00153101|143103290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.0082||95.0|1.05|1.35|||Regression, Cox|||||1.35|1.05|0.0082
71801860|NCT00153101|143103290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.2164||95.0|0.95|1.23|||Regression, Cox|||||1.23|0.95|0.2164
71801861|NCT00153101|143103291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.3732||95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|0.3732
71801862|NCT00153101|143103291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.3633||95.0|0.94|1.2|||Regression, Cox|||||1.20|0.94|0.3633
71801863|NCT00153101|143103292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.2713||95.0|0.97|1.13|||Regression, Cox|||||1.13|0.97|0.2713
71801864|NCT00153101|143103292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.515||95.0|0.95|1.11|||Regression, Cox|||||1.11|0.95|0.5150
71801865|NCT00153101|143103293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.3485||95.0|0.77|1.1|||Regression, Cox|||for subjects without diabetes at baseline||1.10|0.77|0.3485
71801866|NCT00153101|143103293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.1235||95.0|0.96|1.36|||Regression, Cox|||for subjects without diabetes at baseline||1.36|0.96|0.1235
71801867|NCT00153101|143103294|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99||||0.869||95.0|0.89|1.11|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.11|0.89|0.8690
71801868|NCT00153101|143103294|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.4337||95.0|0.94|1.17|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline||1.17|0.94|0.4337
71801869|NCT00153101|143103295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.2666||95.0|0.83|1.05|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.05|0.83|0.2666
71801870|NCT00153101|143103295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.4784||95.0|0.85|1.08|||Regression, Cox|||for subjects without atrial fibrillation at baseline||1.08|0.85|0.4784
71801871|NCT00153101|143103296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0483||95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.0483
71801872|NCT00153101|143103297|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2192||95.0|0.81|1.05|||Regression, Cox|||||1.05|0.81|0.2192
71801873|NCT00153101|143103298|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7764||95.0|0.85|1.24|||Regression, Cox|||||1.24|0.85|0.7764
71801874|NCT00153101|143103299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0574||95.0|0.62|1.01|||Regression, Cox|||||1.01|0.62|0.0574
71801875|NCT00153101|143103300|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.1365||95.0|0.64|1.06|||Regression, Cox|||||1.06|0.64|0.1365
71801876|NCT00153101|143103301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.694||95.0|0.82|1.34|||Regression, Cox|||||1.34|0.82|0.6940
71801877|NCT00153101|143103302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.0245||95.0|1.06|2.35|||Regression, Cox|||||2.35|1.06|0.0245
71801878|NCT00153101|143103303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.5798||95.0|0.36|1.76|||Regression, Cox|||||1.76|0.36|0.5798
71801879|NCT00153101|143103304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0006||95.0|0.65|0.89|||Regression, Cox|||||0.89|0.65|0.0006
71801880|NCT00153101|143103305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.0085||95.0|0.48|0.9|||Regression, Cox|||||0.90|0.48|0.0085
71893714|NCT04871815|143308898|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 1 baseline (day 1 of study) vs Day 7 treatment (day 14 of study).||||<0.0001
71893715|NCT04871815|143308898|SUPERIORITY|||||||0.0114||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day 7 baseline (day 7 of study) vs Day 1 treatment (day 7 of study).||||0.0114
71893716|NCT04871815|143308898|SUPERIORITY||||||<|0.0001||||||Tukey's Multiple comparison test (p-value is adjusted for multiple comparisons)|Tukey's HSD|||Day7 baseline (day 7 of study) vs Day 7 treatment (day 14 of study)||||<0.0001
71893717|NCT02120417|143308899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.932||||0.762|TWO_SIDED|80.0|0.694|1.252|||Log Rank|The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.||||1.252|0.694|0.762
71893718|NCT04885257|143308926|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71893719|NCT03040154|143308938|SUPERIORITY||Odds Ratio (OR)|2.67||||0.006|TWO_SIDED|95.0|1.33|5.35|||Regression, Logistic|||||5.35|1.33|0.006
71801881|NCT00153101|143103306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.0015||95.0|0.69|0.92|||Regression, Cox|||||0.92|0.69|0.0015
71801882|NCT00153101|143103307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0101||95.0|1.08|1.79|||Regression, Cox|||||1.79|1.08|0.0101
71801883|NCT00153101|143103308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9563||95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.9563
71801884|NCT00153101|143103309|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.0868||95.0|0.98|1.41|||Chi-squared|||||1.41|0.98|0.0868
71801885|NCT00153101|143103310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0172||95.0|0.6|0.95|||Regression, Cox|||||0.95|0.60|0.0172
71801886|NCT00153101|143103311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1431||95.0|0.78|1.04|||Regression, Cox|||||1.04|0.78|0.1431
71801887|NCT00153101|143103312|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8974||95.0|0.81|1.21|||Regression, Cox|||||1.21|0.81|0.8974
71801888|NCT02610140|143103313|SUPERIORITY||Hazard Ratio (HR)|1.215||||0.859125|TWO_SIDED|95.0|0.85|||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.|Log Rank||Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.|PFS anetumab ravtansine / vinorelbine||1,738|0.850|0.859125
71801889|NCT02610140|143103314|SUPERIORITY||Hazard Ratio (HR)|1.072||||0.655624|TWO_SIDED|95.0|0.763|1.506||1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). Alpha spending/boundary for interim was 0.00245. Alpha boundary value for final analysis was 0.02421.|Log Rank||Hazard ratio (anetumab ravtansine/vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by TTP on 1st line treatment.|OS anetumab ravtansine / vinorelbine||1.506|0.763|0.655624
71801890|NCT02610140|143103319|SUPERIORITY||Difference (%) improvement rate symptoms|4.65||||0.244|TWO_SIDED|95.0|-8.2|17.51|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||Anetumab ravtansine versus vinorelbine||17.51|-8.20|0.244
71801891|NCT02610140|143103320|SUPERIORITY||Hazard Ratio (HR)|0.829||||0.313747|TWO_SIDED|95.0|0.386|1.779|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.779|0.386|0.313747
71801892|NCT02610140|143103321|SUPERIORITY||Hazard Ratio (HR)|0.924||||0.378916|TWO_SIDED|95.0|0.557|1.533|||Log Rank|one-sided log-rank test stratified by time to progression (TTP) on first line treatment||Anetumab ravtansine versus vinorelbine||1.533|0.557|0.378916
71801893|NCT02610140|143103322|SUPERIORITY||Difference (%) improvement rate of pain|6.64||||0.214|TWO_SIDED|95.0|-9.4|22.68|||Cochran-Mantel-Haenszel|1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment||||22.68|-9.40|0.214
71801894|NCT02610140|143103325|SUPERIORITY||Mean Difference (Final Values)|9.5|||||TWO_SIDED|95.0|0.1|39.3||||||||39.3|0.1|
71801895|NCT02610140|143103325|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|0.0|35.9||||||||35.9|0.0|
71801896|NCT03169153|143103326|SUPERIORITY||||||<|0.0001|||||||Mixed effects repeated measures|||||||<0.0001
71801897|NCT00887341|143103327|SUPERIORITY_OR_OTHER|||||||0.238|||||||Chi-squared|||||||0.238
71801898|NCT00887341|143103334|SUPERIORITY_OR_OTHER|||||||0.121|||||||Chi-squared|||Week 4||||0.121
71801899|NCT00887341|143103334|SUPERIORITY_OR_OTHER|||||||0.809|||||||Chi-squared|||Week 8||||0.809
71801900|NCT00887341|143103334|SUPERIORITY_OR_OTHER|||||||0.367|||||||Chi-squared|||Week 12||||0.367
71801901|NCT00887341|143103334|SUPERIORITY_OR_OTHER|||||||0.339|||||||Chi-squared|||Week 16||||0.339
71801902|NCT00887341|143103334|SUPERIORITY_OR_OTHER|||||||0.017|||||||Chi-squared|||Week 20||||0.017
71801903|NCT00887341|143103334|SUPERIORITY_OR_OTHER|||||||0.451|||||||Chi-squared|||Final visit||||0.451
71801904|NCT00887341|143103335|SUPERIORITY_OR_OTHER|||||||0.377|||||||Chi-squared|||Week 4||||0.377
71801905|NCT00887341|143103335|SUPERIORITY_OR_OTHER|||||||0.387|||||||Chi-squared|||Week 8||||0.387
71801906|NCT00887341|143103335|SUPERIORITY_OR_OTHER|||||||0.304|||||||Chi-squared|||Week 12||||0.304
71801907|NCT00887341|143103335|SUPERIORITY_OR_OTHER|||||||0.509|||||||Chi-squared|||Week 16||||0.509
71801908|NCT00887341|143103335|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Week 20||||0.110
71801909|NCT00887341|143103335|SUPERIORITY_OR_OTHER|||||||0.504|||||||Chi-squared|||Final visit||||0.504
71801910|NCT00887341|143103336|SUPERIORITY_OR_OTHER|||||||0.327|||||||Chi-squared|||Week 4||||0.327
71801911|NCT00887341|143103336|SUPERIORITY_OR_OTHER|||||||0.786|||||||Chi-squared|||Week 8||||0.786
71801912|NCT00887341|143103336|SUPERIORITY_OR_OTHER|||||||0.482|||||||Chi-squared|||Week 12||||0.482
71801913|NCT00887341|143103336|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||Week 16||||0.680
71801914|NCT00887341|143103336|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Week 20||||0.690
71801915|NCT00887341|143103336|SUPERIORITY_OR_OTHER|||||||0.516|||||||Chi-squared|||Final Visit||||0.516
71801916|NCT00887341|143103337|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||Week 8||||0.970
71893720|NCT03542682|143308939|SUPERIORITY||Mean Difference (Final Values)|-55.67|||||TWO_SIDED|95.0|-124.63|13.3|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||13.30|-124.63|
71893721|NCT03542682|143308941|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|95.0|-1.1|3.02|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||3.02|-1.10|
71893722|NCT03542682|143308942|SUPERIORITY||Mean Difference (Final Values)|131.85|||||TWO_SIDED|95.0|-246.7|510.41|||Mixed Models Analysis|The model adjusted for order of the clamps and accounting for within subject correlation.||||510.41|-246.70|
71893723|NCT00914628|143308992|SUPERIORITY|||||||0.8974|||||||Log Rank|||||||0.8974
71801917|NCT00887341|143103337|SUPERIORITY_OR_OTHER|||||||0.587|||||||Chi-squared|||Week 12||||0.587
71801918|NCT00887341|143103337|SUPERIORITY_OR_OTHER|||||||0.184|||||||Chi-squared|||Week 16||||0.184
71801919|NCT00887341|143103337|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||Week 20||||0.600
71801920|NCT00887341|143103337|SUPERIORITY_OR_OTHER|||||||0.937|||||||Chi-squared|||Final Visit||||0.937
71801921|NCT01649856|143103346|SUPERIORITY_OR_OTHER||Difference in Response Rates|8.2||||0.076||95.0|-1.1|17.5|||Chi-squared|||||17.5|-1.1|0.076
71801922|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||||95.0|1.5|1.79|||||Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.79|1.50|
71801923|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||||95.0|1.17|1.41|||||Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.41|1.17|
71801924|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||||95.0|1.59|2.0|||||Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||2.00|1.59|
71801925|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
71801926|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||||95.0|1.41|1.94|||||Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.94|1.41|
71801927|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||||95.0|1.26|1.76|||||Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.76|1.26|
71801928|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||||95.0|1.23|1.57|||||Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.57|1.23|
71801929|NCT01331694|143103404|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization|||1.51|1.17|
71801930|NCT00983580|143103407|SUPERIORITY|||||||0.448|||||||Chi-squared|||||||0.448
71801931|NCT00983580|143103408|SUPERIORITY|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||This statistical analysis compares the difference between the number of patients with No adenoma recurrence at 12 months with those with adenoma recurrence at 12 months.||||0.358
71801932|NCT00983580|143103410|SUPERIORITY|||||||0.513|||||||t-test, 2 sided|||||||0.513
71801933|NCT01652716|143103414|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.1349||0.0072|TWO_SIDED|95.0|-0.63|-0.1|||Mixed model for repeated measure (MMRM)|Based on a repeated measures mixed model including fixed categorical effects of treatment||||-0.10|-0.63|0.0072
71801934|NCT01652716|143103415|SUPERIORITY_OR_OTHER|||||||0.2247|||||||Cochran-Mantel-Haenszel|||||||0.2247
71801935|NCT01652716|143103416|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|5.841||0.1656|TWO_SIDED|95.0|-21.7|1.3||Adjusted|Cochran-Mantel-Haenszel|||||1.3|-21.7|0.1656
71801936|NCT01652716|143103417|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4497||0.3744|TWO_SIDED|95.0|-0.48|1.28|||Cochran-Mantel-Haenszel|||||1.28|-0.48|0.3744
71801937|NCT01652716|143103418|SUPERIORITY_OR_OTHER||LS Mean Difference|26.74|STANDARD_ERROR_OF_MEAN|15.8957||0.0985|TWO_SIDED|95.0|-5.16|58.64|||Cochran-Mantel-Haenszel|||||58.64|-5.16|0.0985
71801938|NCT04551105|143103438|SUPERIORITY||different in area under the LROC curve|0.0374|||<|0.05|TWO_SIDED|95.0|0.019|0.0557|||OR-DBM model|||||0.0557|0.0190|<0.05
71801939|NCT04551105|143103439|SUPERIORITY||Mean Difference (Net)|12.78|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71801940|NCT04551105|143103440|SUPERIORITY||different in sensitivity|-0.0013|||<|0.05|TWO_SIDED|95.0|-0.2307|0.2281|||McNemar|||||0.2281|-0.2307|<0.05
71893724|NCT00914628|143308992|SUPERIORITY|||||||0.7612|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population- from baseline to day 21||||0.7612
71893725|NCT00914628|143308992|SUPERIORITY|||||||0.5995|||||||Log Rank|||||||0.5995
71893726|NCT00914628|143308992|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Intention-To-Treat population - day 21 after transplant||||0.4078
71893727|NCT00914628|143308992|SUPERIORITY|||||||0.3351|||||||Log Rank|||DFS- Per-Protocol Set||||0.3351
71893728|NCT00914628|143308992|SUPERIORITY|||||||0.1233|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set||||0.1233
71801941|NCT04551105|143103440|SUPERIORITY||different in specificity|0.1065|||<|0.05|TWO_SIDED|95.0|0.0008|0.2122|||McNemar|||||0.2122|0.0008|<0.05
71801942|NCT04551105|143103440|SUPERIORITY||different in PPV|-0.086|||<|0.05|TWO_SIDED|95.0|-0.1824|0.0104|||McNemar|||||0.0104|-0.1824|<0.05
71801943|NCT04551105|143103440|SUPERIORITY||different in NPV|0.086|||<|0.05|TWO_SIDED|95.0|-0.0104|0.1824|||McNemar|||||0.1824|-0.0104|<0.05
71801944|NCT02447991|143103441|SUPERIORITY||||||<|0.33||||||Significance level p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.33
71801945|NCT02447991|143103442|SUPERIORITY||||||<|0.18||||||Signficant at p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication||||<0.18
71801946|NCT02447991|143103443|SUPERIORITY||||||<|0.62||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.62
71801947|NCT02447991|143103444|SUPERIORITY||||||<|0.19||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportions of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness as measured by the proportion of treated episodes in which subjects experience freedom from vestibular symptoms (i.e., severity rating of Grade 0) at 1 hour after taking study medication.||||<0.19
71801948|NCT02447991|143103445|SUPERIORITY||||||<|0.14||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.14
71840997|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.449||||0.5616|TWO_SIDED|95.0|-327.445|94.547|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||94.547|-327.445|0.5616
71893729|NCT00914628|143308992|EQUIVALENCE|||||||0.5995|||||||Log Rank|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.5995
71893730|NCT00914628|143308992|SUPERIORITY|||||||0.4078|||||||Wilcoxon (Mann-Whitney)|||DFS- Per-Protocol Set DFS-day 21 after transplant||||0.4078
71893731|NCT00914628|143308993|SUPERIORITY|||||||0.766|||||||Log Rank|Statistical analysis was performed on Intention-To-Treat population.||||||0.7660
71801949|NCT02447991|143103446|SUPERIORITY||||||<|0.72||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.72
71801950|NCT02447991|143103447|SUPERIORITY||||||<|0.48||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication.||||<0.48
71801951|NCT02447991|143103448|SUPERIORITY||||||<|0.35||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting as measured by the proportion of treated episodes in which subjects experience a reduction in severity rating from Grade 3/2 to Grade 1/0 at 1 hour after taking study medication..||||<0.35
71801952|NCT02447991|143103449|SUPERIORITY||||||<|0.022||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with effectiveness of study medication||||<0.022
71801953|NCT02447991|143103449|SUPERIORITY||||||<|0.418||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with side effects of study medication||||<0.418
71801954|NCT02447991|143103449|SUPERIORITY||||||<|0.674||||||Significance of threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with convenience of study medication||||<0.674
71801955|NCT02447991|143103449|SUPERIORITY||||||<|0.016||||||Significance of threshold of p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on the Treatment Satisfaction Questionnaire for Medication at 48 hours after each attack treated with overall satisfaction of study medication||||<0.016
71893732|NCT00914628|143308993|SUPERIORITY|||||||0.6706|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Intention-To-Treat population.||||0.6706
71893733|NCT00914628|143308993|SUPERIORITY|||||||0.7332|||||||Log Rank|||Statistical analysis has been performed for Per-Protocol Set)||||0.7332
71893734|NCT00914628|143308993|SUPERIORITY|||||||0.6439|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis has been performed for Per-Protocol Set)||||0.6439
71893735|NCT00914628|143308994|SUPERIORITY|||||||0.1735|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.1735
71893736|NCT00914628|143308994|SUPERIORITY|||||||0.5958|||||||Chi-squared|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.5958
71893737|NCT00914628|143308994|SUPERIORITY|||||||0.2889|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2889
71677323|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.017|||||TWO_SIDED|95.0|0.676|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.676|
71801956|NCT02447991|143103450|SUPERIORITY||||||<|0.009||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on physical well-being||||<0.009
71801957|NCT02447991|143103450|SUPERIORITY||||||<|0.467||||||Significance threshold p\<0.05|Regression, Linear|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo on mental well-being||||<0.467
71801958|NCT02447991|143103451|SUPERIORITY||||||<|0.013||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients.This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to fatigue.||||<0.013
71801959|NCT02447991|143103451|SUPERIORITY||||||<|0.021||||||Significance threshold p\<0.05|Logistic regression with GEE|GEE=generalized estimating equations - this accounts for repeated measures within patients. This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be tolerated as well as placebo with regard to sleepiness/drowsiness||||<0.021
71893738|NCT00914628|143308994|SUPERIORITY|||||||0.1642|||||||Chi-squared|||This Statistical analysis refers to Immune reconstitution and was performed by Gray's Test for Equality of Cumulative Incidence Functions for Per-Protocol Set.||||0.1642
71893739|NCT00914628|143308994|SUPERIORITY|||||||0.8739|||||||Log Rank|||This Statistical analysis refers to deaths without previous immune reconstitution, relapse or progression and was performed by Gray's Test for Equality of Cumulative Incidence Functions for intention-To-Treat population||||0.8739
71893740|NCT00914628|143308994|SUPERIORITY|||||||0.2304|||||||Chi-squared|||This Statistical Analysis refers to patients with relapse or progression without previous immune reconstitution and was performed Gray's Test for Equality of Cumulative Incidence Functions||||0.2304
71893741|NCT00914628|143308999|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This Statistical Analysis refers to ITT Patients with relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.3526
71893742|NCT00914628|143308999|SUPERIORITY|||||||0.4035|||||||Chi-squared|||this Gray's Statistical Analysis refers to ITT Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.4035
71893743|NCT00914628|143308999|SUPERIORITY|||||||0.2607|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS patients with relapse or progression and was performed with Test for Equality of Cumulative Incidence Functions||||0.2607
71893744|NCT00914628|143308999|SUPERIORITY|||||||0.5929|||||||Chi-squared|||this Gray's Statistical Analysis refers to PPS Deaths patients without previous relapse or progression and was performed with Test for Equality of Cumulative Incidence Function||||0.5929
71893745|NCT00914628|143309003|SUPERIORITY|||||||0.4035|||||||Chi-squared|||This Statistical Analysis refers to ITT Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.4035
71893746|NCT00914628|143309003|SUPERIORITY|||||||0.3526|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.3526
71893747|NCT00914628|143309003|SUPERIORITY|||||||0.5929|||||||Chi-squared|||This Statistical Analysis refers to PPS Deaths without previous relapse or progression and was performed with Gray's Test for Equality of Cumulative Incidence Functions||||0.5929
71893748|NCT00914628|143309003|SUPERIORITY|||||||0.2607|||||||Chi-squared|||This statistical test refers to Patients with relapse or progression and was performed to Gray's Test for Equality of Cumulative Incidence Functions.||||0.2607
71893749|NCT00469079|143309014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.002
71801960|NCT02447991|143103452|SUPERIORITY||||||<|0.76||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of vertigo measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.76
71801961|NCT02447991|143103453|SUPERIORITY||||||<|0.041||||||Significance threshold p \< 0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of unsteadiness/dizziness episodes measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.041
71801962|NCT02447991|143103454|SUPERIORITY||||||<|0.12||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of headaches measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.12
71801963|NCT02447991|143103455|SUPERIORITY||||||<|0.051||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of photophobia/phonophobia measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.051
71801964|NCT02447991|143103456|SUPERIORITY||||||<|0.006||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of sensitivity to motion measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.006
71801965|NCT02447991|143103457|SUPERIORITY||||||<|0.67||||||Significance threshold p\<0.05|Chi-squared, Corrected|This analysis applies to proportion of treated episodes.||Hypothesis: Rizatriptan will be superior to placebo in reducing the severity of nausea/vomiting measured by the proportion of treated episodes that subjects rate at grade 1/0 24 hours after taking study medication.||||<0.67
71801966|NCT00459134|143103458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.19||0.576|TWO_SIDED|95.0|-1.67|3.0||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||3.00|-1.67|0.576
71801967|NCT00459134|143103459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.49|STANDARD_ERROR_OF_MEAN|1.73||0.01|TWO_SIDED|95.0|1.09|7.89||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.||7.89|1.09|0.010
71801968|NCT01612546|143103468|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
71801969|NCT01016834|143103473|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject's rating of overall treatment satisfaction at the end of study based on the subject's experience using Sumavel DosePro and the rating at baseline based on the subject's pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance||||0.0007
71801970|NCT04177693|143103533|SUPERIORITY|||||||0.112|||||||Kruskal-Wallis|||||||0.112
71801971|NCT04177693|143103534|SUPERIORITY|||||||0.613|||||||Kruskal-Wallis|||||||0.613
71801972|NCT04177693|143103535|SUPERIORITY|||||||0.202|||||||Kruskal-Wallis|||||||0.202
71801973|NCT04177693|143103536|SUPERIORITY|||||||0.508|||||||Kruskal-Wallis|||||||0.508
71801974|NCT04177693|143103537|SUPERIORITY|||||||0.237|||||||Kruskal-Wallis|||||||0.237
71801975|NCT04177693|143103538|SUPERIORITY|||||||0.327|||||||Kruskal-Wallis|||||||0.327
71801976|NCT04177693|143103539|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||||||0.633
71801977|NCT04177693|143103540|SUPERIORITY|||||||0.146|||||||Kruskal-Wallis|||||||0.146
71801978|NCT04177693|143103541|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
71801979|NCT04177693|143103542|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71801980|NCT04177693|143103543|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71801981|NCT02710630|143103544|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|119.33|STANDARD_DEVIATION|40.4|||TWO_SIDED|90.0|101.838|139.834|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||139.834|101.838|
71801982|NCT02710630|143103544|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|52.97|STANDARD_DEVIATION|168.9|||TWO_SIDED|90.0|33.341|84.158|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||84.158|33.341|
71801983|NCT02710630|143103544|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|59.01|STANDARD_DEVIATION|73.4|||TWO_SIDED|90.0|45.255|76.955|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.955|45.255|
71801984|NCT02710630|143103544|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.21|STANDARD_DEVIATION|55.7|||TWO_SIDED|90.0|87.698|133.53|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.530|87.698|
71801985|NCT02710630|143103544|SUPERIORITY_OR_OTHER||Ratio|110.21|STANDARD_DEVIATION|41.1|||TWO_SIDED|90.0|93.939|129.297|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.297|93.939|
71801986|NCT02710630|143103545|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|99.569|140.579|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||140.579|99.569|
71801987|NCT02710630|143103545|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|57.49|STANDARD_DEVIATION|132.3|||TWO_SIDED|90.0|38.502|85.837|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||85.837|38.502|
71801988|NCT02710630|143103545|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|61.94|STANDARD_DEVIATION|69.0|||TWO_SIDED|90.0|48.13|79.72|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||79.720|48.130|
71801989|NCT02710630|143103545|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|108.26|STANDARD_DEVIATION|55.8|||TWO_SIDED|90.0|87.704|133.629|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||133.629|87.704|
71840998|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-162.635||||0.2176|TWO_SIDED|95.0|-375.57|50.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||50.299|-375.570|0.2176
71840999|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-236.196||||0.0242|TWO_SIDED|95.0|-451.334|-21.059|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-21.059|-451.334|0.0242
71841000|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-294.281|||<|0.0001|TWO_SIDED|95.0|-434.513|-154.05|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-154.050|-434.513|<.0001
71841001|NCT04800211|143191006|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-116.17||||0.1524|TWO_SIDED|95.0|-275.521|43.18|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||43.180|-275.521|0.1524
71841002|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-32.792|||<|0.0001|TWO_SIDED|95.0|-39.375|-26.208|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-26.208|-39.375|<.0001
71841003|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-25.921|||<|0.0001|TWO_SIDED|95.0|-33.398|-18.443|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-18.443|-33.398|<.0001
71893750|NCT00469079|143309015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Mixed Models Analysis|||Product use is by self-report and daily diaries.||||0.05
71841004|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.484|||<|0.0001|TWO_SIDED|95.0|-31.99|-18.979|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-18.979|-31.990|<.0001
71841005|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.899|||<|0.0001|TWO_SIDED|95.0|-34.135|-19.663|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-19.663|-34.135|<.0001
71841006|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-26.41|||<|0.0001|TWO_SIDED|95.0|-31.716|-21.103|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||-21.103|-31.716|<.0001
71841007|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-7.021||||0.028|TWO_SIDED|95.0|-13.278|-0.763|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||-0.763|-13.278|0.0280
71841008|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-5.902||||0.0972|TWO_SIDED|95.0|-12.881|1.077|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.077|-12.881|0.0972
71841009|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-25.771|||<|0.0001|TWO_SIDED|95.0|-37.189|-14.353|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-14.353|-37.189|<.0001
71841010|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.019||||0.0005|TWO_SIDED|95.0|-32.833|-7.205|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.205|-32.833|0.0005
71893751|NCT00469079|143309016|SUPERIORITY_OR_OTHER_LEGACY||Other|0.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.||This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.||||<0.05
71801990|NCT02710630|143103545|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.76|STANDARD_DEVIATION|43.0|||TWO_SIDED|90.0|91.238|127.281|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.281|91.238|
71801991|NCT02710630|143103546|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|118.26|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|101.627|137.621|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.621|101.627|
71801992|NCT02710630|143103546|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|87.26|STANDARD_DEVIATION|60.2|||TWO_SIDED|90.0|69.404|109.722|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||109.722|69.404|
71801993|NCT02710630|143103546|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|71.4|STANDARD_DEVIATION|49.2|||TWO_SIDED|90.0|58.828|86.648|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||86.648|58.828|
71801994|NCT02710630|143103546|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|116.67|STANDARD_DEVIATION|37.7|||TWO_SIDED|90.0|100.516|135.41|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.410|100.516|
71801995|NCT02710630|143103546|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|109.85|STANDARD_DEVIATION|38.7|||TWO_SIDED|90.0|94.452|127.75|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||127.750|94.452|
71801996|NCT02710630|143103547|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.69|STANDARD_DEVIATION|40.2|||TWO_SIDED|90.0|98.783|135.491|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||135.491|98.783|
71801997|NCT02710630|143103547|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|50.43|STANDARD_DEVIATION|173.7|||TWO_SIDED|90.0|31.519|80.689|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||80.689|31.519|
71841011|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-18.463||||0.0002|TWO_SIDED|95.0|-29.825|-7.101|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||-7.101|-29.825|0.0002
71841012|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.997||||0.0002|TWO_SIDED|95.0|-33.619|-8.375|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-8.375|-33.619|0.0002
71841013|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.508|||<|0.0001|TWO_SIDED|95.0|-29.061|-11.955|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-11.955|-29.061|<.0001
71841014|NCT04800211|143191007|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.978||||0.8504|TWO_SIDED|95.0|-9.216|11.172|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||11.172|-9.216|0.8504
71893752|NCT00469079|143309017|SUPERIORITY_OR_OTHER_LEGACY||Mean difference between 3 groups|0.0|||>|0.1|TWO_SIDED|95.0|||||Mixed Models Analysis|||A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.||||> 0.10
71841015|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.257|||<|0.0001|TWO_SIDED|95.0|-41.957|-20.557|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-20.557|-41.957|<.0001
71841016|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-29.862|||<|0.0001|TWO_SIDED|95.0|-44.234|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-44.234|<.0001
71841017|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.512|||<|0.0001|TWO_SIDED|95.0|-46.971|-16.053|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-16.053|-46.971|<.0001
71841018|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-37.197|||<|0.0001|TWO_SIDED|95.0|-47.522|-26.872|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-26.872|-47.522|<.0001
71841019|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.442|||<|0.0001|TWO_SIDED|95.0|-44.96|-17.923|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-17.923|-44.960|<.0001
71893753|NCT02698410|143309018|OTHER|||||||0.2968||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Comparison of DCR to 30% clinically relevant threshold.||||0.2968
71801998|NCT02710630|143103547|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|56.71|STANDARD_DEVIATION|74.2|||TWO_SIDED|90.0|43.388|74.122|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||74.122|43.388|
71893754|NCT02698410|143309018|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
71893755|NCT02698410|143309018|OTHER|||||||0.0534||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 30% clinically relevant threshold.||||0.0534
71801999|NCT02710630|143103547|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.99|STANDARD_DEVIATION|52.8|||TWO_SIDED|90.0|87.554|130.732|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||130.732|87.554|
71841020|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-28.597||||0.0002|TWO_SIDED|95.0|-43.34|-13.853|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.853|-43.340|0.0002
71802000|NCT02710630|143103547|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.07|STANDARD_DEVIATION|40.7|||TWO_SIDED|90.0|91.399|125.432|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||125.432|91.399|
71802001|NCT02710630|143103548|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.39|STANDARD_DEVIATION|45.3|||TWO_SIDED|90.0|96.74|137.644|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||137.644|96.740|
71802002|NCT02710630|143103548|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|54.12|STANDARD_DEVIATION|138.6|||TWO_SIDED|90.0|35.818|81.774|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||81.774|35.818|
71802003|NCT02710630|143103548|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|58.96|STANDARD_DEVIATION|71.4|||TWO_SIDED|90.0|45.489|76.431|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||76.431|45.489|
71802004|NCT02710630|143103548|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.38|STANDARD_DEVIATION|57.0|||TWO_SIDED|90.0|85.846|131.836|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||131.836|85.846|
71802005|NCT02710630|143103548|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|103.73|STANDARD_DEVIATION|43.3|||TWO_SIDED|90.0|87.74|122.628|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||122.628|87.740|
71802006|NCT02710630|143103549|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|115.27|STANDARD_DEVIATION|38.4|||TWO_SIDED|90.0|99.063|134.13|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||134.130|99.063|
71802007|NCT02710630|143103549|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|83.73|STANDARD_DEVIATION|62.8|||TWO_SIDED|90.0|66.033|106.163|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||106.163|66.033|
71802008|NCT02710630|143103549|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|68.77|STANDARD_DEVIATION|50.3|||TWO_SIDED|90.0|56.452|83.782|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||83.782|56.452|
71802009|NCT02710630|143103549|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|107.13|STANDARD_DEVIATION|49.6|||TWO_SIDED|90.0|88.616|129.51|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||129.510|88.616|
71802010|NCT02710630|143103549|SUPERIORITY_OR_OTHER||Ratio [Test/Reference]|106.64|STANDARD_DEVIATION|38.9|||TWO_SIDED|90.0|91.625|124.114|||||"The adjusted geometric mean (gMean) ratio \[%\] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) \[%\]."|||124.114|91.625|
71802011|NCT03224468|143103571|SUPERIORITY|Power was determined to be 85.2% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.15|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.40|0.15|<0.001
71893756|NCT02698410|143309018|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-1: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
71893757|NCT02698410|143309018|OTHER|||||||0.032||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 30%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 30% clinically relevant threshold.||||0.032
71893758|NCT02698410|143309018|OTHER||||||<|0.0001||||||One-sided p-value estimated using an exact binomial proportion test for one-way tables comparing DCR to 10%.|Binomial proportion test|||Sensitivity Analyisis-2: Comparison of DCR to 10% clinically relevant threshold.||||<0.0001
71893759|NCT01584024|143309034|SUPERIORITY||||||=|0.003|||||||McNemar|||||||=0.003
71802012|NCT03224468|143103572|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.45||0.5|TWO_SIDED|95.0|-1.4|0.4||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in scale score for MM above and beyond WLC (positive values denote higher score for MM).|The mean difference in scale scores between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's scale scores at baseline.||0.4|-1.4|0.50
71802013|NCT03224468|143103573|SUPERIORITY|Power was determined to be 84.3% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.5||0.9|TWO_SIDED|95.0|-0.3|0.24||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.24|-0.30|0.90
71802014|NCT03224468|143103574|SUPERIORITY|Power was determined to be 83.6% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.5||0.93|TWO_SIDED|95.0|-0.38|0.39||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||0.39|-0.38|0.93
71802015|NCT03224468|143103575|SUPERIORITY|Power was determined to be 90.4% using a Monte Carlo simulation approach in which data were simulated from a multi-level linear regression model with a subject-varying random intercept, a shared baseline across WLC and MMC, and fixed effects for a change over each time point. Simulated data were fit with a linear model estimated via GEE - simulations were repeated 1000 times and power was estimated as the proportion where the contrast between WLC and MM had p\<0.05.|Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-1.3|-0.43||The p-value is adjusted for multiple comparisons using per Benjamini \& Hochberg (1995) across the five primary outcome measures. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates were obtained using generalized estimating equations (GEE) with robust standard errors obtained by the sandwich estimator.|Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's number of symptoms at baseline.||-0.43|-1.30|<0.001
71802016|NCT03224468|143103576|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.0|2.5|||||Estimate is the mean difference in number of symptoms for MM above and beyond WLC (positive values denote higher number of symptoms for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at weeks 4 and 12 of the study, and for a subject's score at baseline.||2.5|-1.0|
71802017|NCT03224468|143103578|SUPERIORITY||Mean Difference (Net)|-7.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-19.0|3.5|||||Estimate is the mean difference in the congruency cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||3.5|-19.0|
71802018|NCT03224468|143103579|SUPERIORITY||Mean Difference (Net)|-24.1|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|95.0|-45.9|-2.2|||||Estimate is the mean difference in the switching cost on response time for MM above and beyond WLC (positive values indicate higher cost for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||-2.2|-45.9|
71893760|NCT01584024|143309035|SUPERIORITY||||||=|0.17|||||||McNemar|||||||=0.17
71893761|NCT00893789|143309058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8336||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.8336
71802019|NCT03224468|143103580|SUPERIORITY||Mean Difference (Net)|0.002|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|95.0|-0.007|0.011|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate better ability to identify target items for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.011|-0.007|
71802020|NCT03224468|143103581|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.8|1.7|||||Estimate is the mean difference in number of total errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.7|-1.8|
71802021|NCT03224468|143103582|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-7.4|0.3|||||Estimate is the mean difference in number of repetition errors for MM above and beyond WLC (positive values indicate greater number of errors for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.3|-7.4|
71802022|NCT03224468|143103583|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.1|||||Estimate is the mean difference in discriminability for MM above and beyond WLC (positive values indicate a greater ability to recognize previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||0.1|-0.2|
71802023|NCT03224468|143103584|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.2|1.0|||||Estimate is the mean difference in number recalled for MM above and beyond WLC (positive values indicate a greater ability to recall previously studied words for MM).|The mean difference in number of symptoms between the MM and WLC groups was estimated via a linear model with a dummy-coded contrast (0 for WLC, 1 for MM). The model adjusted for change at week 12 of the study, and for a subject's score at baseline.||1.0|-0.2|
71802024|NCT02461589|143103585|OTHER||Treatment difference|-1.04|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.77|||Mixed Models Analysis|||||-0.77|-1.30|<0.0001
71802025|NCT02461589|143103585|OTHER||Treatment difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.08|||Mixed Models Analysis|||||-1.08|-1.61|<0.0001
71802026|NCT02461589|143103585|OTHER||Treatment difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-1.95|-1.42|||Mixed Models Analysis|||||-1.42|-1.95|<0.0001
71802027|NCT02461589|143103585|OTHER||Treatment difference|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.12|-1.6|||Mixed Models Analysis|||||-1.60|-2.12|<0.0001
71802028|NCT01038921|143103610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0||||0.013|||||||Mixed Models Analysis|||Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.||||0.013
71802029|NCT01978119|143103611|NON_INFERIORITY_OR_EQUIVALENCE|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by capsule-based unit dose DPI versus FSC administered BID by multi-dose DPI is greater than -125 milliliter (mL).|Mean Difference (Net)|0.028|||||TWO_SIDED|95.0|-0.024|0.08|||Repeated Measures Mixed Models|||||0.080|-0.024|
71802030|NCT01978119|143103612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.039|0.334||||||||0.334|-1.039|
71802031|NCT01978119|143103613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|||||TWO_SIDED|95.0|-0.372|0.927||||||||0.927|-0.372|
71802032|NCT01978119|143103614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007|||||TWO_SIDED|95.0|-0.074|0.088|||||Day 28 Change from Baseline Analysis|||0.088|-0.074|
71802033|NCT01978119|143103614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022||||||95.0|-0.049|0.092|||||Day 56 Change from Baseline Analysis|||0.092|-0.049|
71802034|NCT01978119|143103615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.35|||||TWO_SIDED|95.0|-1.34|10.05||||||||10.05|-1.34|
71802035|NCT01978119|143103616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09||||||||0.09|-0.20|
71802036|NCT01978119|143103618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.25|||||TWO_SIDED|95.0|-6.97|2.46||||||||2.46|-6.97|
71893762|NCT00893789|143309058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0514||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0514
71893763|NCT00893789|143309058|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||"P-value for Change from Baseline at Endpoint."||||0.0010
71802037|NCT01978119|143103619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||||0.5|-0.9|
71893764|NCT00893789|143309059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7884||95.0|||||Pearson's chi-squared|||||||0.7884
71802038|NCT01978119|143103620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.64|3.11||||||||3.11|-4.64|
71802039|NCT01958918|143103663|SUPERIORITY|||||||0.185|||||||ANOVA|||||||0.1850
71802040|NCT04327934|143103668|EQUIVALENCE|We compared groups across treatments||||||0.018|||||||ANOVA|||||||0.018
71802041|NCT04327934|143103669|EQUIVALENCE|We compared across groups and within groups over time.|||||<|0.016|||||||ANOVA|||||||<0.016
71802042|NCT04327934|143103669|EQUIVALENCE|We compared across groups and within groups over time.||||||0.08|||||||ANOVA|||||||0.08
71802043|NCT04327934|143103672|OTHER|||||||0.05||||||Friedman's tests to compare slopes|Friedman's test|||||||0.05
71802044|NCT04327934|143103674|OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
71802045|NCT04327934|143103674|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
71802046|NCT04327934|143103675|EQUIVALENCE|We compared groups across treatments||||||0.0023|||||||ANOVA|||||||0.0023
71802047|NCT04327934|143103676|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
71802048|NCT04327934|143103677|OTHER||||||<|0.04|||||||ANOVA|||||||<0.04
71802049|NCT03095417|143103683|SUPERIORITY|||||||0.747|||||||Mixed Models Analysis|||||||0.747
71802050|NCT03095417|143103684|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
71802051|NCT03095417|143103685|SUPERIORITY|||||||0.264|||||||Mixed Models Analysis|||||||0.264
71802052|NCT03095417|143103686|SUPERIORITY|||||||0.511|||||||Mixed Models Analysis|||||||0.511
71802053|NCT03095417|143103687|SUPERIORITY|||||||0.677|||||||Mixed Models Analysis|||||||0.677
71802054|NCT03095417|143103688|SUPERIORITY|||||||0.815|||||||Mixed Models Analysis|||||||0.815
71802055|NCT03095417|143103689|SUPERIORITY|||||||0.719|||||||Mixed Models Analysis|||||||0.719
71802056|NCT03095417|143103690|SUPERIORITY|||||||0.346|||||||Mixed Models Analysis|||||||0.346
71802057|NCT03095417|143103691|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.910
71802058|NCT03095417|143103692|SUPERIORITY|||||||0.794|||||||Mixed Models Analysis|||||||0.794
71802059|NCT03095417|143103693|SUPERIORITY|||||||0.626|||||||Mixed Models Analysis|||||||0.626
71802060|NCT03095417|143103694|SUPERIORITY|||||||0.774|||||||Mixed Models Analysis|||||||0.774
71802061|NCT01260922|143103707|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.16|||||TWO_SIDED|90.0|97.07|107.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.51|97.07|
71802062|NCT01260922|143103708|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|94.75|||||TWO_SIDED|90.0|92.11|97.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||97.46|92.11|
71802063|NCT04165291|143103710|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<.01
71802064|NCT04165291|143103711|OTHER|||||||0.08|||||||ANOVA|||||||.08
71802065|NCT04165291|143103712|SUPERIORITY|||||||0.116|||||||Repeated Measures Analysis of Variance|||||||.116
71802066|NCT04165291|143103713|SUPERIORITY||Mean Difference (Final Values)|5.146|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71802067|NCT04165291|143103714|SUPERIORITY|||||||0.13|||||||ANOVA|||||||.13
71802068|NCT04165291|143103715|SUPERIORITY|||||||0.35|||||||ANOVA|||||||.35
71802069|NCT01410110|143103723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.66|STANDARD_ERROR_OF_MEAN|4.41||0.55|TWO_SIDED|95.0|-11.57|6.25||a prior threshold p \< .05|t-test, 2 sided|df = 40||t-test for equality of means||6.25|-11.57|.55
71802070|NCT01410110|143103724|SUPERIORITY_OR_OTHER||Slope|0.162|STANDARD_ERROR_OF_MEAN|0.94||0.86|TWO_SIDED|95.0|-1.73|2.05||Time X Condition|Mixed Models Analysis|Mixed Models allows for all randomized participants (N=48) to be included in the model.||F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition||2.05|-1.73|.86
71802071|NCT01410110|143103725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.49|STANDARD_ERROR_OF_MEAN|2.41|<|0.31|TWO_SIDED|95.0|-7.36|2.39||a priori threshold p \< .05|t-test, 2 sided|||||2.39|-7.36|<.31
71802072|NCT01410110|143103726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.952||0.87|TWO_SIDED|95.0|-1.77|2.08||a priori threshold p \< .05|t-test, 2 sided|df=39||||2.08|-1.77|.87
71802073|NCT01410110|143103727|SUPERIORITY_OR_OTHER||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.84||0.67|TWO_SIDED|95.0|-2.07|1.33|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)||1.33|-2.07|.67
71802074|NCT01410110|143103728|SUPERIORITY_OR_OTHER||Slope|-0.42|STANDARD_ERROR_OF_MEAN|0.62||0.5|TWO_SIDED|95.0|-1.67|0.83|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)||.83|-1.67|.50
71802075|NCT01410110|143103729|SUPERIORITY_OR_OTHER||Slope|1.16|STANDARD_ERROR_OF_MEAN|0.42||0.008|TWO_SIDED|95.0|0.32|2.01|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,70.15)||2.01|.32|.008
71802076|NCT01410110|143103730|SUPERIORITY_OR_OTHER||Slope|2.025|STANDARD_ERROR_OF_MEAN|0.93||0.03|TWO_SIDED|95.0|0.169|3.93|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,37.8)||3.93|.169|.03
71802077|NCT01410110|143103731|SUPERIORITY_OR_OTHER||Slope|3.86|STANDARD_ERROR_OF_MEAN|2.77||0.17|TWO_SIDED|95.0|-1.73|9.46||a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.|Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)||9.46|-1.73|.17
71802078|NCT02708745|143103732|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||.29
71802079|NCT02708745|143103733|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
71802080|NCT02708745|143103734|SUPERIORITY|||||||0.78||||||For the barrier 'not having enough time to discuss vaccine concerns', P=0.78. For the barrier 'not realizing until late in visit that parent had vaccine concerns', P=0.37. For the barrier 'not understanding parent specific vaccine concerns', P=0.66.|Chi-squared|||||||0.78
71802081|NCT01385059|143103745|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71814039|NCT02401464|143130077|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.979|||||TWO_SIDED|90.0|0.938|1.022||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.022|0.938|
71893765|NCT00893789|143309059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2359||95.0|||||Pearson's chi-squared|||||||0.2359
71841021|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-30.054|||<|0.0001|TWO_SIDED|95.0|-40.943|-19.166|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-19.166|-40.943|<.0001
71802082|NCT01767116|143103751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
71841022|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-5.904||||0.2667|TWO_SIDED|95.0|-16.37|4.563|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.563|-16.370|0.2667
71841023|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|8.767||||0.2085|TWO_SIDED|95.0|-4.95|22.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||22.485|-4.950|0.2085
71841024|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|12.455||||0.1041|TWO_SIDED|95.0|-2.595|27.505|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||27.505|-2.595|0.1041
71841025|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-25.353||||0.0058|TWO_SIDED|95.0|-45.41|-5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-5.295|-45.410|0.0058
71893766|NCT00893789|143309059|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4401||95.0|||||Pearson's chi-squared|||||||0.4401
71893767|NCT04419506|143309089|OTHER||Posterior difference|88.4|||||TWO_SIDED|95.0|29.5|154.2|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||154.2|29.5|
71893768|NCT04419506|143309089|OTHER||Posterior difference|62.4|||||TWO_SIDED|95.0|6.3|125.5|||||Difference calculated as BI 1015550 - Placebo|Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.||125.5|6.3|
71802083|NCT01767116|143103751|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
71802084|NCT01767116|143103752|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|0.5|||||TWO_SIDED|95.0|-0.5|1.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides \>95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).||1.4|-0.5|
71802085|NCT01767116|143103753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71802086|NCT01767116|143103754|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|98.2|100.0|||||95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.2|
71802087|NCT01767116|143103754|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|99.5|||||TWO_SIDED|95.0|98.6|100.0|||||95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides \>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).||100.0|98.6|
71802088|NCT01242527|143103757|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.68||||0.005|TWO_SIDED|95.0|-40.7|-2.89||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors|||-2.89|-40.70|0.005
71802089|NCT01242527|143103757|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-21.19||||0.007|TWO_SIDED|95.0|-40.32|-2.29||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-2.29|-40.32|0.007
71802090|NCT01242527|143103757|SUPERIORITY_OR_OTHER||Placebo adjusted % change from baseline|-26.6|||<|0.001|TWO_SIDED|95.0|-45.12|-8.38||P-value adjusted with Dunnett's procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|||-8.38|-45.12|<0.001
71802091|NCT01975389|143103758|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.021469|TWO_SIDED|95.0|0.65|0.97|||Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.65|0.021469
71802092|NCT01975389|143103759|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.007597|TWO_SIDED|95.0|0.6|0.93|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.93|0.60|0.007597
71893769|NCT02513940|143309091|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71893770|NCT02513940|143309092|SUPERIORITY|||||||0.001||||||"Pairwise comparisons:~Testosterone vs placebo: p=0.008 Progesterone vs placebo: p=0.73 Testosterone vs progesterone: p=0.0008"|Mixed Models Analysis|||||||0.001
71893771|NCT02513940|143309093|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Repeated measures ANOVA||||||0.60
71802093|NCT01975389|143103760|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.035958|TWO_SIDED|95.0|0.68|0.99|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.99|0.68|0.035958
71802094|NCT01975389|143103761|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.015694|TWO_SIDED|95.0|0.64|0.95|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.95|0.64|0.015694
71802095|NCT01975389|143103762|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.814224|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.46|0.62|0.814224
71802096|NCT01975389|143103763|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.018053|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.96|0.65|0.018053
71802097|NCT01975389|143103764|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.446033|TWO_SIDED|95.0|0.5|1.36|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.36|0.50|0.446033
71802098|NCT01975389|143103765|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.029977|TWO_SIDED|95.0|0.57|0.97|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.97|0.57|0.029977
71677324|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.673|||||TWO_SIDED|95.0|0.448|1.012||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.012|0.448|
71802099|NCT01975389|143103766|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.162615|TWO_SIDED|95.0|0.14|1.44|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.44|0.14|0.162615
71802100|NCT01975389|143103767|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.051534|TWO_SIDED|95.0|0.59|1.0|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.00|0.59|0.051534
71802101|NCT01975389|143103768|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
71802102|NCT01975389|143103769|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.294331|TWO_SIDED|95.0|0.5|1.24|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.24|0.50|0.294331
71802103|NCT01975389|143103771|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.104998|TWO_SIDED|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.09|0.41|0.104998
71802104|NCT01975389|143103772|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6012|TWO_SIDED|95.0|0.6|1.34|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.34|0.60|0.601200
71802105|NCT01975389|143103773|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.678061|TWO_SIDED|95.0|0.72|1.67|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.67|0.72|0.678061
71802106|NCT01975389|143103774|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.010457|TWO_SIDED|95.0|0.63|0.94|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.94|0.63|0.010457
71802107|NCT01975389|143103775|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.509847|TWO_SIDED|95.0|0.71|2.01|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||2.01|0.71|0.509847
71802108|NCT01975389|143103776|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.002981|TWO_SIDED|95.0|0.58|0.9|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||0.90|0.58|0.002981
71802109|NCT01975389|143103777|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.748975|TWO_SIDED|95.0|0.7|1.3|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.30|0.70|0.748975
71802110|NCT01975389|143103778|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.626157|TWO_SIDED|95.0|0.63|1.32|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.||1.32|0.63|0.626157
71814040|NCT02207725|143130105|SUPERIORITY||Hodges-Lehman estimate of shift|-74.55|||<|0.0001|TWO_SIDED|95.0|-78.39|-66.28|||2-sided test exact Wilcoxon rank-sum tes|||||-66.28|-78.39|<0.0001
71814041|NCT02207725|143130105|SUPERIORITY||Hodges-Lehman estimate of shift|-59.5|||<|0.0001|TWO_SIDED|95.0|-64.1|-55.17|||2-sided test exact Wilcoxon rank-sum tes|||||-55.17|-64.10|<0.0001
71893772|NCT02513940|143309094|SUPERIORITY|||||||0.0003||||||"Pairwise comparisons:~Testosterone vs placebo: p = 0.0001 Progesterone vs placebo: p = 0.25 Testosterone vs progesterone: p = 0.002"|Mixed Models Analysis|Repeated measures ANOVA||||||0.0003
71893773|NCT02513940|143309095|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Fatigue||||>0.99
71893774|NCT02513940|143309095|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||Rash at gel application site||||>0.99
71893775|NCT01021007|143309127|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.005
71893776|NCT01021007|143309128|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
71893777|NCT01021007|143309129|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.||||0.05
71893778|NCT00087438|143309130|SUPERIORITY_OR_OTHER|||||||0.013||||||Test statistic = \[ln(estimated hazard rate) - ln(hypothesized hazard rates)\] / \[1/square root (number of patients with local progression by two years\]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.|z-test, one-sided|||Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.||||0.013
71893779|NCT00594399|143309164|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of insulin|Mixed Models Analysis|||||||0.43
71893780|NCT00594399|143309167|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of glucose|Mixed Models Analysis|||||||0.91
71893781|NCT00594399|143309170|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus test of difference between groups over time with adjustment for baseline value of physical activity|Mixed Models Analysis|||||||<0.001
71893782|NCT02698189|143309308|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.000; upper = 0.415|||
71893783|NCT02698189|143309308|OTHER|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.040; upper = 0.391|||
71893784|NCT00613626|143309351|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|22.718||0.1|ONE_SIDED|90.0|||||Log Rank|||A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.||||0.10
71893785|NCT00613626|143309351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9518|TWO_SIDED|||||P-Value (2-tailed) is calculated based on the unstratified log-rank test.|Log Rank|Degrees of freedom=1||||||0.9518
71893786|NCT00613626|143309353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2533|TWO_SIDED||||||Difference in Rates|P-value (two-tailed) is calculated based on an unadjusted, normal-distribution approximation for the difference in rates.||||||0.2533
71893787|NCT00613626|143309354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872|TWO_SIDED||||||Difference in Rates|||||||0.8720
71893788|NCT00613626|143309355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4577|TWO_SIDED||||||Log Rank|||||||0.4577
71893789|NCT00613626|143309356|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.05|||||TWO_SIDED|95.0|||||||Survival analysis of VEGF variants using cox proportional hazard analysis in arm A and arm B.|Data was not collected for safety lead-in participants and these participants were not included in the analysis.||||
71893790|NCT00613626|143309356|SUPERIORITY_OR_OTHER_LEGACY||Logistic Regression Analysis|0.05|||||TWO_SIDED|95.0|||||||Objective Response Analysis of VEGF variants using Logistic Regression Analysis in arm A and arm B|||||
71893791|NCT05480514|143309357|SUPERIORITY|A superiority margin of 0.90 was used. Superiority was concluded if the lower bound of the 95% central posterior credible interval was above 0.90.|Mean Posterior Proportion|0.9741|STANDARD_DEVIATION|0.01244|||TWO_SIDED|95.0|0.9445|0.9926|||Bayesian beta-binomial model|||||0.9926|0.9445|
71893792|NCT00457639|143309358|SUPERIORITY||Mean Difference (Net)|13.8||||0.42|TWO_SIDED|95.0|-19.7|61.1|||Mixed Models Analysis|||||61.1|-19.7|0.42
71802111|NCT01975389|143103779|SUPERIORITY||LS mean difference|-56.9|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|-57.91|-55.89|||MMRM|||Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-55.89|-57.91|<0.001
71893793|NCT00457639|143309359|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.45|TWO_SIDED|95.0|-17.7|50.8|||Mixed Models Analysis|||||50.8|-17.7|0.45
71893794|NCT03232073|143309370|SUPERIORITY||Treatment Effect (Rate Ratio)|0.779||||||95.0|0.629|0.965||||||||0.965|0.629|
71893795|NCT01672892|143309408|SUPERIORITY|||||||0.0476|||||||t-test, 1 sided|||Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.||||0.0476
71893796|NCT01672892|143309409|SUPERIORITY|||||||0.4338|||||||Binomial test of proportions|2-sided significance level = 0.05||||||0.4338
71893797|NCT01672892|143309410|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 3 of RT||||0.04
71893798|NCT01672892|143309410|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 5 of RT||||0.03
71893799|NCT01672892|143309410|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|2-sided significance level of 0.05||4-6 weeks post-RT||||0.41
71893800|NCT01672892|143309411|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-G total score - 5 weeks||||0.54
71893801|NCT01672892|143309411|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|FACT-G total score - 4-6 weeks post RT||FACT-G total score - 4-6 weeks post RT||||0.72
71893802|NCT01672892|143309411|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 5 weeks||||0.01
71893803|NCT01672892|143309411|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 4-6 weeks post RT||||0.45
71893804|NCT01672892|143309411|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 5 weeks||||0.03
71893805|NCT01672892|143309411|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 4-6 weeks post RT||||0.9
71893806|NCT01672892|143309411|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 5 weeks||||0.55
71841026|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-38.63||||0.001|TWO_SIDED|95.0|-65.062|-12.197|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-12.197|-65.062|0.0010
71841027|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-43.967||||0.0005|TWO_SIDED|95.0|-72.443|-15.491|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-15.491|-72.443|0.0005
71893807|NCT01672892|143309411|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 4-6 weeks post RT||||0.35
71893808|NCT01672892|143309411|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 5 weeks||||0.66
71893809|NCT01672892|143309411|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 4-6 weeks post RT||||0.09
71893810|NCT01672892|143309411|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 5 weeks||||0.66
71893811|NCT01672892|143309411|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 4-6 weeks post RT||||0.35
71893812|NCT01672892|143309412|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|2-sided significance level = 0.05||5 weeks||||0.61
71893813|NCT01672892|143309412|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|2-sided significance level = 0.05||4-6 weeks post-RT||||0.67
71893814|NCT01672892|143309413|SUPERIORITY|||||||0.81|||||||Gray's test|Two-sided significance level = 0.05||||||0.81
71893815|NCT01672892|143309414|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.21|TWO_SIDED|95.0|0.82|2.35|||Log Rank|Two-side significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||2.35|0.82|0.21
71893816|NCT01672892|143309415|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.53|TWO_SIDED|95.0|0.32|1.79|||Log Rank|Two-sided significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy|||1.79|0.32|0.53
71893817|NCT01672892|143309418|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Baseline||||<0.0001
71893818|NCT01672892|143309418|OTHER||||||<|0.0001|||||||nonparametric one-sample t-test|||Week 5||||<0.0001
71893819|NCT01672892|143309419|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at baseline||||<0.0001
71893820|NCT01672892|143309419|OTHER||||||<|0.0001|||||||One-sample t-test|||Bowel domain at week 5||||<0.0001
71893821|NCT01672892|143309419|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at baseline||||<0.0001
71893822|NCT01672892|143309419|OTHER||||||<|0.0001|||||||One-sample t-test|||Urinary domain at week 5||||<0.0001
71893823|NCT01672892|143309420|OTHER||||||<|0.0001|||||||Paired t-test|||Bowel domain||||<0.0001
71893824|NCT01672892|143309420|OTHER||||||<|0.0001|||||||Paired t-test|||Urinary domain||||<0.0001
71893825|NCT01756157|143309449|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.61||||0.0523|TWO_SIDED|95.0|-1.23|0.01|||Paired t-test, 2 sided|||||0.01|-1.23|0.0523
71893826|NCT02559505|143309461|OTHER|||||||0.005||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.005
71893827|NCT02559505|143309461|OTHER|||||||0.024||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.024
71893828|NCT02559505|143309462|OTHER|||||||0.408||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.408
71893829|NCT02559505|143309462|OTHER|||||||0.004||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.004
71893830|NCT02559505|143309463|OTHER|||||||0.991||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.991
71893831|NCT02559505|143309463|OTHER|||||||0.334||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.334
71893832|NCT02559505|143309464|OTHER|||||||0.226||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.226
71893833|NCT02559505|143309464|OTHER|||||||0.036||||||p-value for NP reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.036
71893834|NCT02559505|143309465|OTHER|||||||0.68||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.680
71893835|NCT02559505|143309465|OTHER|||||||0.002||||||p-value for H3 reactivity, difference of Acute Infected vs. Vaccinated.|ANCOVA|||||||0.002
71893836|NCT04331899|143309482|OTHER||Cox Proportional Hazard|0.81||||0.29|TWO_SIDED|95.0|0.56|1.19||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.19|0.56|0.29
71841028|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-31.293||||0.0003|TWO_SIDED|95.0|-51.159|-11.428|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-11.428|-51.159|0.0003
71841029|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-40.209||||0.0004|TWO_SIDED|95.0|-65.941|-14.477|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-14.477|-65.941|0.0004
71841030|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-41.052||||0.0011|TWO_SIDED|95.0|-68.965|-13.138|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-13.138|-68.965|0.0011
71841031|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-42.509|||<|0.0001|TWO_SIDED|95.0|-60.902|-24.116|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||-24.116|-60.902|<.0001
71893837|NCT04331899|143309483|OTHER||Cox Proportional Hazard|-0.06||||0.91|TWO_SIDED|95.0|-1.23|1.11||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Log change at Day 14. Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.11|-1.23|0.91
71893838|NCT04331899|143309484|OTHER||Cox Proportional Hazard|1.01||||0.95|TWO_SIDED|95.0|0.85|1.16||Tests were conducted at the 0.05 level of significance.|Regression, Linear||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.16|0.85|0.95
71893839|NCT04331899|143309485|OTHER||Cox Proportional Hazard|0.94||||0.76|TWO_SIDED|95.0|0.6|1.41||Tests were conducted at the 0.05 level of significance.|Regression, Cox||Cox proportional hazards model covariate-adjusted for age 50+ and sex.|||1.41|0.60|0.76
71893840|NCT00101361|143309487|NON_INFERIORITY_OR_EQUIVALENCE|the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.|Mean Difference (Final Values)|-5.7|||<|0.05|TWO_SIDED|95.0|-17.5|6.8|||Cochran-Mantel-Haenszel|||For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.||6.8|-17.5|<0.05
71893841|NCT02424539|143309488|OTHER||Mean Difference (Final Values)|-1.23|||<|0.001|TWO_SIDED|95.0|-1.68|-0.78|||ANCOVA||Least square (LS) mean difference between placebo and FF 55 µg QD has been presented using analysis of co-variance (ANCOVA) model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.78|-1.68|<0.001
71893842|NCT02424539|143309488|OTHER||Mean Difference (Final Values)|-1.32|||<|0.001|TWO_SIDED|95.0|-1.77|-0.87|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.87|-1.77|<0.001
71893843|NCT02424539|143309489|OTHER||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.14|0.39|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.39|0.14|<0.001
71802112|NCT01975389|143103780|SUPERIORITY||LS mean difference|-73.8|STANDARD_ERROR_OF_MEAN|0.67|<|0.001|TWO_SIDED|95.0|-75.11|-72.5|||MMRM|||LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-72.50|-75.11|<0.001
71802113|NCT01975389|143103781|SUPERIORITY||LS mean difference|-39.31|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-40.55|-38.06|||ANCOVA|||LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.||-38.06|-40.55|<0.001
71802114|NCT01975389|143103782|SUPERIORITY||LS mean difference|-51.87|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-52.81|-50.94|||MMRM|||Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.94|-52.81|<0.001
71802115|NCT01975389|143103782|SUPERIORITY||LS mean difference|-18.41|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-19.96|-16.86|||MMRM|||VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-16.86|-19.96|<0.001
71802116|NCT01975389|143103782|SUPERIORITY||LS mean difference|-29.2|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-31.44|-26.96|||MMRM|||RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-26.96|-31.44|<0.001
71893844|NCT02424539|143309489|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.33|0.12|<0.001
71802117|NCT01975389|143103782|SUPERIORITY||LS mean difference|-51.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-52.37|-50.42|||MMRM|||Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-50.42|-52.37|<0.001
71802118|NCT01975389|143103782|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|6.33|7.5|||MMRM|||HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||7.50|6.33|<0.001
71802119|NCT01975389|143103782|SUPERIORITY||LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|3.9|4.9|||MMRM|||Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||4.90|3.90|<0.001
71802120|NCT01975389|143103782|SUPERIORITY||LS mean difference|-37.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-38.75|-37.22|||MMRM|||Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and complete statin intolerance.||-37.22|-38.75|<0.001
71802121|NCT01975389|143103783|SUPERIORITY||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.81|0.83|||MMRM|||Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.83|0.81|<0.001
71802122|NCT01975389|143103783|SUPERIORITY||LS mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.67|0.69|||MMRM|||Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.||0.69|0.67|<0.001
71802123|NCT01975389|143103784|SUPERIORITY||LS mean difference|1.06||||0.002|TWO_SIDED|95.0|1.02|1.09|||MMRM|||LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and complete statin intolerance.||1.09|1.02|0.002
71802124|NCT01312961|143103794|SUPERIORITY||Odds Ratio (OR)|0.077|||<|0.0001|TWO_SIDED|95.0|0.021|0.28||Threshold for significance at 0.05 level.|Regression, Logistic||Dupilumab 300 mg vs. Placebo|Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.||0.280|0.021|<0.0001
71814042|NCT02207725|143130106|SUPERIORITY||Hodges-Lehman estimate of shift|-77.14|||<|0.0001|TWO_SIDED|95.0|-79.98|-74.04|||2-sided test exact Wilcoxon rank-sum tes|||||-74.04|-79.98|<0.0001
71814043|NCT02207725|143130108|SUPERIORITY||Hodges-Lehman estimate of shift|-7.09|||<|0.0001|TWO_SIDED|95.0|-8.86|-5.42|||2-sided test exact Wilcoxon rank-sum tes|||||-5.42|-8.86|<0.0001
71814044|NCT02207725|143130108|SUPERIORITY||Hodges-Lehman estimate of shift|-3.02||||0.0002|TWO_SIDED|95.0|-5.66|-1.25|||2-sided test exact Wilcoxon rank-sum tes|||||-1.25|-5.66|0.0002
71814045|NCT02207725|143130109|SUPERIORITY||Hodges-Lehman estimate of shift|1227.35|||<|0.0001|TWO_SIDED|95.0|984.01|1456.38|||2-sided test exact Wilcoxon rank-sum tes|||||1456.38|984.01|<0.0001
71814046|NCT02207725|143130109|SUPERIORITY||Hodges-Lehman estimate of shift|999.33|||<|0.0001|TWO_SIDED|95.0|819.5|1200.53|||2-sided test exact Wilcoxon rank-sum tes|||||1200.53|819.50|<0.0001
71802125|NCT04278417|143103814|NON_INFERIORITY|Non-inferiority of brolucizumab to PRP with respect to change from baseline in BCVA at Week 54, considering a non-inferiority margin of 4 ETDRS letters. Assuming that the BCVA changes follow a normal distribution with equal means between treatments, and a common standard deviation of 10 letters, for a one-sided alpha level of 0.025, with 300 subjects per arm there is \>99% power to reject the null hypothesis that brolucizumab 6 mg is inferior to PRP.|LS mean difference|4.4|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|2.4|6.4|||ANCOVA|||1||6.4|2.4|<0.001
71802126|NCT04278417|143103814|SUPERIORITY||||||<|0.001|||||||ANCOVA|||2||||<0.001
71802127|NCT04278417|143103815|SUPERIORITY||Difference in % of Participants|39.4|||<|0.001|TWO_SIDED|95.0|32.0|46.8|||Cochran-Mantel-Haenszel|||||46.8|32.0|< 0.001
71802128|NCT04278417|143103817|SUPERIORITY||Difference in % of Participants|-41.1|||<|0.001|TWO_SIDED|95.0|-48.0|-34.2|||Cochran-Mantel-Haenszel|||||-34.2|-48.0|< 0.001
71802129|NCT04278417|143103820|SUPERIORITY||Difference in % of Participants|26.4|||<|0.001|TWO_SIDED|95.0|19.5|33.3|||Cochran-Mantel-Haenszel|||Week 54||33.3|19.5|<0.001
71802130|NCT01971346|143103854|OTHER|||||||0.38||||||Type III TNF-alpha p-value=0.36. Type III IFN-alpha p-value=0.36. Interaction was not included in this model.|Regression, Linear|||A cumulative score reflecting change in PASI during the course of treatment was calculated and treated as a continuous response variable. Linear modeling was done to determine if change in PASI score was associated with the baseline TNF-alpha signal, baseline IFN-alpha signal and/or an interaction between these two signals.||||0.38
71802131|NCT01971346|143103855|OTHER|||||||0.03||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.03 Test of Hypotheses for Within subject effect of Time p-value=0.38 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.31|ANOVA|||The strength of the TNF-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if TNF-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.03
71802132|NCT01971346|143103856|OTHER|||||||0.34||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.34 Test of Hypotheses for Within subject effect of Time p-value=0.73 Test of Hypotheses for Within subject effect of Time\*PASI profile p-value=0.57|ANOVA|||The strength of the IFN-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if IFN-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.||||0.34
71802133|NCT03735862|143103859|OTHER|Paired t-Test|||||<|0.001|||||||t-test, 1 sided|||Difference between baseline and follow-up||||<0.001
71802134|NCT03735862|143103860|SUPERIORITY||||||<|0.0001|||||||McNemar|||Difference between baseline and follow-up||||<0.0001
71802135|NCT00360334|143103922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.71|||<|0.001||95.0|2.62|8.46|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome||8.46|2.62|<0.001
71802136|NCT00360334|143103923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.001||95.0|3.11|10.64|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||10.64|3.11|<0.001
71802137|NCT00360334|143103924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71802138|NCT00360334|143103925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.28||95.0|0.44|1.26|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.26|0.44|0.280
71802139|NCT00360334|143103926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.191||95.0|0.42|1.19|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.19|0.42|0.191
71802140|NCT00360334|143103927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.363||95.0|0.66|3.07|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||3.07|0.66|0.363
71802141|NCT00360334|143103929|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
71802142|NCT00360334|143103930|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
71802143|NCT00360334|143103931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
71802144|NCT00360334|143103932|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Model Repeated Measures|||||||<0.001
71802145|NCT00360334|143103933|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Repeated Measures|||||||<0.001
71802146|NCT00360334|143103934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.91||||0.001||95.0|3.7|210.54|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||210.54|3.70|0.001
71802147|NCT00360334|143103936|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Model Repeated Measures|||||||0.014
71802148|NCT00360334|143103937|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Mixed Model Repeated Measures|||||||0.100
71802149|NCT00360334|143103938|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||ANCOVA|||||||0.125
71802150|NCT00360334|143103939|SUPERIORITY_OR_OTHER|||||||0.471||95.0|||||ANCOVA|||||||0.471
71802151|NCT00360334|143103940|SUPERIORITY_OR_OTHER|||||||0.601||95.0|||||ANCOVA|||||||0.601
71802152|NCT00360334|143103941|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||ANCOVA|||||||0.650
71802153|NCT00360334|143103942|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||ANCOVA|||||||0.017
71802154|NCT00360334|143103943|SUPERIORITY_OR_OTHER|||||||0.667||95.0|||||ANCOVA|||||||0.667
71802155|NCT00360334|143103944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.675||||0.139||95.0|0.401|1.136|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||1.136|0.401|0.139
71893845|NCT02424539|143309490|OTHER||Mean Difference (Final Values)|-2.15|||<|0.001|TWO_SIDED|95.0|-2.84|-1.46|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.46|-2.84|<0.001
71893846|NCT02424539|143309490|OTHER||Mean Difference (Final Values)|-1.98|||<|0.001|TWO_SIDED|95.0|-2.66|-1.29|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.29|-2.66|<0.001
71893847|NCT02424539|143309491|OTHER||Mean Difference (Final Values)|-0.1||||0.503|TWO_SIDED|95.0|-0.38|0.18|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.18|-0.38|0.503
71893848|NCT02424539|143309491|OTHER||Mean Difference (Final Values)|-0.25||||0.078|TWO_SIDED|95.0|-0.53|0.03|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.03|-0.53|0.078
71802156|NCT00360334|143103945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.317||||0.001||95.0|0.159|0.63|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||0.630|0.159|0.001
71802157|NCT00360334|143103946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.716||95.0|0.235|2.705|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome||2.705|0.235|0.716
71802158|NCT00360334|143103947|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||ANCOVA on ranks|||||||0.113
71802159|NCT00360334|143103948|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA on ranks|||||||<0.001
71802160|NCT00360334|143103949|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANCOVA on ranks|||||||0.740
71802161|NCT00594256|143103950|SUPERIORITY_OR_OTHER||||||=|0.002||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||=0.002
71802162|NCT00594256|143103951|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.02
71802163|NCT00594256|143103952|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.04
71893849|NCT02424539|143309492|OTHER||Mean Difference (Final Values)|0.51||||0.048|TWO_SIDED|95.0|0.01|1.02|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.02|0.01|0.048
71893850|NCT02424539|143309492|OTHER||Mean Difference (Final Values)|0.66||||0.011|TWO_SIDED|95.0|0.16|1.17|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||1.17|0.16|0.011
71802164|NCT00594256|143103953|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||Open label baseline final paired t test||||0.8
71802165|NCT00594256|143103954|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||Open label baseline final paired t test||||<0.01
71802166|NCT04160260|143103955|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|95.17|||||TWO_SIDED|90.0|84.2|107.5|||||A t-test on the natural log-transformed PK parameter AUC(0-48) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg intravenous (IV) omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log Geometric Mean (GM) AUC(0-48) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.98 (0.2091).||107.5|84.2|
71802167|NCT04160260|143103956|EQUIVALENCE|Omadacycline 300 mg PO provided equivalent total exposure as measured by AUC relative to omadacycline 100 mg IV.|Geometric Mean Ratio|100.8|||||TWO_SIDED|90.0|88.0|115.5|||||A t-test on the natural log-transformed PK parameter AUC(0-24) was performed to obtain the Geometric Mean Ratio and its confidence interval.|Comparison was performed with the 100 mg IV omadacycline treatment group (data were obtained from 6 completed studies-NCT numbers not available). Using the Day 1 plasma concentration profile of the 100 mg IV QD dosing from these studies, a BID dosing on Day 1 and a QD dosing on Day 2 was simulated using the superposition principle. Log GM AUC(0-24) of omadacycline for the 100 mg IV omadacycline group was as follows:Participants analyzed=63; GM (SD)=9.26 (0.1985).||115.5|88.0|
71802168|NCT03837496|143103975|SUPERIORITY||Slope|-0.66||||0.504|TWO_SIDED|95.0|-2.59|1.27||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression.||Analysis comparing the change in monthly adherence to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||1.27|-2.59|.504
71802169|NCT03837496|143103975|SUPERIORITY||Slope|-0.17||||0.225|TWO_SIDED|95.0|-0.44|-0.1||a priori threshold p\<0.05|ANCOVA|Adjusted for distress and receipt of ovarian suppression||Analysis comparing the change in weekly adherence rates to adjuvant endocrine therapy across the study period adjusting for distress and receipt of ovarian suppression.||-0.10|-0.44|.225
71814047|NCT02801669|143130135|OTHER||Cox Proportional Hazard|0.339||||0.0003|TWO_SIDED|95.0|0.188|0.608|||Regression, Cox|The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.||This statistical analysis assesses the annual incidence of composite event of stroke and SEE between treatment groups.||0.608|0.188|0.0003
71814048|NCT02801669|143130136|OTHER||Cox Proportional Hazard|0.299|||||TWO_SIDED|95.0|0.157|0.57|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of stroke between treatment groups.||0.570|0.157|
71814049|NCT02801669|143130136|OTHER||Cox Proportional Hazard|0.503|||||TWO_SIDED|95.0|0.126|2.011|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of SEE between treatment groups.||2.011|0.126|
71814050|NCT02801669|143130136|OTHER||Cox Proportional Hazard|0.306|||||TWO_SIDED|95.0|0.16|0.585|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke between treatment groups.||0.585|0.160|
71802170|NCT03837496|143103976|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.63|TWO_SIDED|95.0|-0.4|0.66||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in self-reported endocrine therapy adherence between groups on the MARS-5 scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||0.66|-0.40|.630
71802171|NCT03837496|143103977|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.186|TWO_SIDED|95.0|-1.27|6.44||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in satisfaction with adjuvant endocrine therapy between groups on the CTSQ from baseline to 12 weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||6.44|-1.27|.186
71802172|NCT03837496|143103978|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.562|TWO_SIDED|95.0|-3.49|1.91||a priori threshold p \< 0.05|ANCOVA|Adjusted for baseline values of criterion outcomes, distress and receipt of ovarian suppression||Analysis comparing the change in symptom distress between groups on the BCPT scale from baseline to 12-weeks post-baseline adjusting for distress, receipt of ovarian suppression, and baseline values of criterion outcome.||1.91|-3.49|.562
71802173|NCT03779841|143103992|SUPERIORITY||Risk Ratio (RR)|0.8||||0.1612|TWO_SIDED|95.0|0.58|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.58|0.1612
71802174|NCT03779841|143103992|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7789|TWO_SIDED|95.0|0.79|1.37|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.37|0.79|0.7789
71802175|NCT03779841|143103993|SUPERIORITY|||||||0.2972|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.2972
71802176|NCT03779841|143103993|SUPERIORITY|||||||0.8722|||||||stratified Wilcoxon (Van Elteren)|||P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8722
71802177|NCT03779841|143103994|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9814|TWO_SIDED|95.0|0.5|1.96|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.96|0.50|0.9814
71802178|NCT03779841|143103994|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9715|TWO_SIDED|95.0|0.5|1.97|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.97|0.50|0.9715
71802179|NCT03779841|143103995|SUPERIORITY|||||||0.1281|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.1281
71802180|NCT03779841|143103995|SUPERIORITY|||||||0.882|||||||Log Rank|||P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.||||0.8820
71802181|NCT03779841|143103996|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1623|TWO_SIDED|95.0|0.57|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.57|0.1623
71802182|NCT03779841|143103996|SUPERIORITY||Risk Ratio (RR)|1.04||||0.7776|TWO_SIDED|95.0|0.78|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.78|0.7776
71802183|NCT03779841|143103997|SUPERIORITY||Risk Ratio (RR)|0.79||||0.1603|TWO_SIDED|95.0|0.56|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.56|0.1603
71802184|NCT03779841|143103997|SUPERIORITY||Risk Ratio (RR)|1.06||||0.6706|TWO_SIDED|95.0|0.8|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.80|0.6706
71802185|NCT03779841|143103998|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1583|TWO_SIDED|95.0|0.55|1.1|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.10|0.55|0.1583
71802186|NCT03779841|143103998|SUPERIORITY||Risk Ratio (RR)|1.07||||0.6694|TWO_SIDED|95.0|0.8|1.43|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.43|0.80|0.6694
71802187|NCT03779841|143103999|SUPERIORITY||Risk Ratio (RR)|0.81||||0.2578|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2578
71802188|NCT03779841|143103999|SUPERIORITY||Risk Ratio (RR)|1.05||||0.7526|TWO_SIDED|95.0|0.76|1.47|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.47|0.76|0.7526
71802189|NCT03779841|143104000|SUPERIORITY||Risk Ratio (RR)|0.8||||0.2549|TWO_SIDED|95.0|0.55|1.18|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.18|0.55|0.2549
71802190|NCT03779841|143104000|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8544|TWO_SIDED|95.0|0.73|1.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.45|0.73|0.8544
71802191|NCT03779841|143104001|SUPERIORITY||Risk Ratio (RR)|0.74||||0.1718|TWO_SIDED|95.0|0.48|1.14|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.14|0.48|0.1718
71802192|NCT03779841|143104001|SUPERIORITY||Risk Ratio (RR)|0.83||||0.3801|TWO_SIDED|95.0|0.54|1.27|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.27|0.54|0.3801
71841032|NCT04800211|143191008|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-2.915||||0.7835|TWO_SIDED|95.0|-23.855|18.025|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||18.025|-23.855|0.7835
71802193|NCT03779841|143104002|SUPERIORITY||Risk Ratio (RR)|0.87||||0.5531|TWO_SIDED|95.0|0.54|1.39|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.39|0.54|0.5531
71802194|NCT03779841|143104002|SUPERIORITY||Risk Ratio (RR)|0.82||||0.4213|TWO_SIDED|95.0|0.51|1.33|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.33|0.51|0.4213
71802195|NCT03779841|143104003|SUPERIORITY||Risk Ratio (RR)|0.92||||0.804|TWO_SIDED|95.0|0.49|1.73|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.73|0.49|0.8040
71802196|NCT03779841|143104003|SUPERIORITY||Risk Ratio (RR)|1.1||||0.7573|TWO_SIDED|95.0|0.61|1.98|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.98|0.61|0.7573
71802197|NCT03779841|143104004|SUPERIORITY||Risk Ratio (RR)|0.69||||0.4065|TWO_SIDED|95.0|0.28|1.67|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.67|0.28|0.4065
71802198|NCT03779841|143104004|SUPERIORITY||Risk Ratio (RR)|1.28||||0.5257|TWO_SIDED|95.0|0.6|2.7|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.70|0.60|0.5257
71802199|NCT03779841|143104005|SUPERIORITY||Risk Ratio (RR)|0.78||||0.1612|TWO_SIDED|95.0|0.55|1.11|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.11|0.55|0.1612
71802200|NCT03779841|143104005|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9966|TWO_SIDED|95.0|0.74|1.35|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.35|0.74|0.9966
71802201|NCT03779841|143104006|SUPERIORITY||Risk Ratio (RR)|0.68||||0.3374|TWO_SIDED|95.0|0.3|1.52|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.52|0.30|0.3374
71802202|NCT03779841|143104006|SUPERIORITY||Risk Ratio (RR)|1.23||||0.5403|TWO_SIDED|95.0|0.62|2.45|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||2.45|0.62|0.5403
71841033|NCT04800211|143191009|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.769||||0.0002|TWO_SIDED|95.0|-1.228|-0.309|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.309|-1.228|0.0002
71841034|NCT04800211|143191009|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|-0.52||||0.0175|TWO_SIDED|95.0|-0.972|-0.068|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood WBC (x 10\^3/uL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||-0.068|-0.972|0.0175
71841035|NCT04800211|143191010|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)|Mean Difference (Net)|2.408||||0.0362|TWO_SIDED|95.0|0.11|4.705|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population with Outliers Excluded)||4.705|0.110|0.0362
71841036|NCT04800211|143191010|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.692||||0.2142|TWO_SIDED|95.0|-0.569|3.953|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Serum HDL-C (mg/dL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.953|-0.569|0.2142
71893851|NCT02424539|143309493|OTHER||Mean Difference (Final Values)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.83|-0.9|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.90|-1.83|<0.001
71893852|NCT02424539|143309493|OTHER||Mean Difference (Final Values)|-1.46|||<|0.001|TWO_SIDED|95.0|-1.92|-0.99|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.99|-1.92|<0.001
71802203|NCT03779841|143104007|SUPERIORITY||Risk Ratio (RR)|3.94||||0.0163|TWO_SIDED|95.0|1.16|13.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||13.42|1.16|0.0163
71893853|NCT02424539|143309494|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.34|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.34|0.12|<0.001
71893854|NCT02424539|143309494|OTHER||Odds Ratio (OR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.29|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald's test with treatment, gender, age and type of Allergic Rhinitis as factors.|||0.29|0.10|<0.001
71893855|NCT02424539|143309495|OTHER||Mean Difference (Final Values)|-2.48|||<|0.001|TWO_SIDED|95.0|-3.23|-1.73|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.73|-3.23|<0.001
71802204|NCT03779841|143104007|SUPERIORITY||Risk Ratio (RR)|2.7||||0.1101|TWO_SIDED|95.0|0.76|9.64|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||9.64|0.76|0.1101
71802205|NCT03779841|143104008|SUPERIORITY||Risk Ratio (RR)|0.86||||0.3339|TWO_SIDED|95.0|0.64|1.16|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.16|0.64|0.3339
71802206|NCT03779841|143104008|SUPERIORITY||Risk Ratio (RR)|1.1||||0.4614|TWO_SIDED|95.0|0.85|1.42|||Cochran-Mantel-Haenszel|||P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).||1.42|0.85|0.4614
71893856|NCT02424539|143309495|OTHER||Mean Difference (Final Values)|-2.27|||<|0.001|TWO_SIDED|95.0|-3.03|-1.52|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-1.52|-3.03|<0.001
71893857|NCT02424539|143309496|OTHER||Mean Difference (Final Values)|-0.11||||0.442|TWO_SIDED|95.0|-0.38|0.17|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||0.17|-0.38|0.442
71893858|NCT02424539|143309496|OTHER||Mean Difference (Final Values)|-0.3||||0.035|TWO_SIDED|95.0|-0.57|-0.02|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||-0.02|-0.57|0.035
71893859|NCT02424539|143309497|OTHER||Mean Difference (Final Values)|1.88||||0.004|TWO_SIDED|95.0|0.6|3.16|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.16|0.60|0.004
71893860|NCT02424539|143309497|OTHER||Mean Difference (Final Values)|2.67|||<|0.001|TWO_SIDED|95.0|1.38|3.95|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.|||3.95|1.38|<0.001
71893861|NCT04893265|143309511|SUPERIORITY||Mean Difference (Net)|0.0854|STANDARD_ERROR_OF_MEAN|0.1122||0.4471|TWO_SIDED|95.0|-0.1352|0.306|||Mixed Models Analysis|||||0.3060|-0.1352|0.4471
71802207|NCT03483623|143104033|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802208|NCT03483623|143104034|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802209|NCT03483623|143104035|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71893862|NCT04893265|143309512|SUPERIORITY||Odds Ratio (OR)|0.8378|||<|0.05|TWO_SIDED|95.0|0.4284|1.6385|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||1.6385|0.4284|<0.05
71893863|NCT04893265|143309513|SUPERIORITY||Odds Ratio (OR)|1.4306|||<|0.05|TWO_SIDED|95.0|0.6166|3.3192|||Mixed Models Analysis|Adjusted for Demographics, COVID-19 Cases Per 100K , Test Access, Social Network, Knowledge, Test Value with random intercepts for participation mode|Adjusted odds ratio|||3.3192|0.6166|<0.05
71893864|NCT04893265|143309514|SUPERIORITY||Mean Difference (Final Values)|0.08661|STANDARD_ERROR_OF_MEAN|0.08125|||TWO_SIDED|95.0|-0.07311|0.2463|||||Adjusted for Demographics, COVID Cases Per 100,000 Population, Test Access, Social Network, Knowledge, and Test Value with random intercepts for Dyad and Individual|||0.2463|-0.07311|
71893865|NCT03818815|143309527|SUPERIORITY|||||||0.62||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.62
71893866|NCT03818815|143309528|SUPERIORITY|||||||0.07||||||The p-value was calculated using multiple imputation with number of imputations equal to percentage of missing data.|Regression, Logistic|||The summary statistics are based on subjects with non-missing data only.||||0.07
71893867|NCT01475955|143309552|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Chi-squared|||Pearson chi-square||||0.0041
71802210|NCT03483623|143104036|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802211|NCT03483623|143104037|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802212|NCT03483623|143104038|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802213|NCT03483623|143104039|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802214|NCT03483623|143104040|SUPERIORITY|||||||0.0001||||||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations-NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS||||0.0001
71802215|NCT02276495|143104055|SUPERIORITY|||||||0.668|||||||Kruskal-Wallis|||||||0.668
71802216|NCT02276495|143104056|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
71802217|NCT02276495|143104057|SUPERIORITY|||||||0.013|||||||Kruskal-Wallis|||||||0.013
71802218|NCT00612313|143104063|SUPERIORITY_OR_OTHER||Difference in percentages|9.7||||0.02|TWO_SIDED|||||The estimated rate of time spent well was evaluated using a Poisson regression with adjustment for CDRS-R score at the end of the acute phase, age group, and gender.|Regression, Poisson||Differencein percentages represents estimated percentage for medication management + CBT Arm minus estimated percentage for medication management only Arm.|||||.02
71802219|NCT01175824|143104085|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be concluded if the upper limit of the 95% confidence interval (CI) of the difference in the LS mean between the two treatment arms (twice-daily insulin lispro Low Mixture minus the comparator arm) at 24 weeks is \<0.4%.|LS mean difference|-0.21|||||TWO_SIDED|95.0|-0.38|-0.04||||||||-0.04|-0.38|
71802220|NCT01175824|143104086|SUPERIORITY_OR_OTHER|||||||0.1858||95.0|||||Mixed Models Analysis|||||||0.1858
71893868|NCT00728416|143309705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.31|||<|0.001|TWO_SIDED|95.0|-0.43|-0.19|||ANCOVA|||The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.||-0.19|-0.43|<0.001
71802221|NCT01175824|143104087|SUPERIORITY_OR_OTHER|||||||0.3588||95.0||||HbA1c concentration \<7%|Fisher Exact|||||||0.3588
71802222|NCT01175824|143104087|SUPERIORITY_OR_OTHER|||||||0.5958||95.0||||HbA1c \<=6.5%|Fisher Exact|||||||0.5958
71893869|NCT00728416|143309706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.27|||<|0.001|TWO_SIDED|95.0|-1.72|-0.83|||ANCOVA|||The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.||-0.83|-1.72|<0.001
71893870|NCT01244737|143309714|OTHER||Pearson correlation co-efficient|0.8|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|||This is a diagnostic test of FLT uptake (SUV max) as a predictor of cellular proliferation (MIB) and is performed as an analysis of correlation using each evaluable participant enrolled in either Arm 1 (New Diagnosis) or Arm 2 (Possible recurrent tumor). The groups (Arm 1 and Arm 2) provide pathways for enrollment. Correlation between the two measures of outcome (SUV max and MIB) is evaluated.||||< 0.001
71893871|NCT01244737|143309717|OTHER|Paired T-test to assess change in FLT uptake (SUV max) with chemotherapy.||||||0.04||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.04
71893872|NCT03133767|143309810|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
71893873|NCT03133767|143309811|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
71893874|NCT03133767|143309812|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
71893875|NCT03133767|143309813|SUPERIORITY|||||||0.361|||||||Chi-squared|||||||0.361
71893876|NCT03133767|143309814|SUPERIORITY|||||||0.509|||||||Chi-squared|||||||0.509
71802223|NCT01175824|143104088|SUPERIORITY_OR_OTHER|||||||0.0827||95.0||||p-value is for the Week 12 comparison|Mixed Models Analysis|||||||0.0827
71802224|NCT01175824|143104088|SUPERIORITY_OR_OTHER|||||||0.5353||95.0||||p-value is for the Week 24 comparison|Mixed Models Analysis|||||||0.5353
71802225|NCT01175824|143104092|SUPERIORITY_OR_OTHER|||||||0.2833||95.0||||p-value is for the comparison at Week 12.|Mixed Models Analysis|||||||0.2833
71802226|NCT01175824|143104092|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||p-value is for the comparison at Week 24.|Mixed Models Analysis|||||||0.0176
71802227|NCT01175824|143104098|SUPERIORITY_OR_OTHER||LS mean difference|-0.22|||||TWO_SIDED|95.0|-0.39|-0.05||||Superiority will be concluded if of 95% CI upper limit for treatment difference (2x-daily insulin lispro LM minus the comparator arm) at 24 wks is \<0%||||-0.05|-0.39|
71802228|NCT00009737|143104105|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.|Hazard Ratio (HR)|0.87||||0.053|TWO_SIDED|95.0|0.75|1.0||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.00|0.75|0.053
71802229|NCT00009737|143104106|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.86||||0.041|TWO_SIDED|95.0|0.74|0.99||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||0.99|0.74|0.041
71802230|NCT00009737|143104107|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.84||||0.071|TWO_SIDED|95.0|0.69|1.01||For difference between arms, \< 0.001 for non-inferiority|Wald Chi-Square Test|||||1.01|0.69|0.071
71802231|NCT01807585|143104111|NON_INFERIORITY|Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.|Risk Difference (RD)|3.5|||<|0.0001|TWO_SIDED|95.0|-0.7|7.6|||One tailed Z-test|||Last Observation Carried Forward (LOCF)||7.6|-0.7|<0.0001
71802232|NCT01163682|143104114|NON_INFERIORITY|"This tests determined the odds of an increase of greater than or equal to 2 points on the BPI-SF worst pain score, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.~Null Hypothesis: electro-acupucture does not prevent taxane-induced peripheral neuropathy"|Odds Ratio (OR)|1.16||||0.25|TWO_SIDED|95.0|0.9|1.5|||Regression, Logistic|||||1.50|0.90|0.25
71814051|NCT02801669|143130136|OTHER||Cox Proportional Hazard|0.347|||||TWO_SIDED|95.0|0.193|0.624|||||The treatment groups were compared using a Cox proportional hazard model with the CHADS2 score (\<= 2 or \>= 3) as covariate.|This statistical analysis assesses the annual incidence of ischemic stroke/SEE between treatment groups.||0.624|0.193|
71893877|NCT03664726|143309815|SUPERIORITY|||||||0.0034||||||Comparison of differences by group|ANOVA|||||||0.0034
71893878|NCT03664726|143309816|SUPERIORITY|||||||0.76|||||||ANOVA|||||||0.76
71893879|NCT03664726|143309817|SUPERIORITY|||||||0.77|||||||ANOVA|||||||0.77
71893880|NCT03119649|143309820|SUPERIORITY||Difference in LS Means|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.4291|TWO_SIDED|95.0|-11.6|5.0||P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.0|-11.6|0.4291
71893881|NCT03119649|143309820|SUPERIORITY||Difference in LS Means|-4.1|STANDARD_ERROR_OF_MEAN|4.32||0.3477|TWO_SIDED|95.0|-12.8|4.6||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.6|-12.8|0.3477
71893882|NCT03119649|143309820|SUPERIORITY||Difference in LS Means|-15.8|STANDARD_ERROR_OF_MEAN|3.72|<|0.0001|TWO_SIDED|95.0|-23.2|-8.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||-8.3|-23.2|<0.0001
71893883|NCT03119649|143309820|SUPERIORITY||Difference in LS Means|-6.3|STANDARD_ERROR_OF_MEAN|3.76||0.0995|TWO_SIDED|95.0|-13.9|1.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||1.2|-13.9|0.0995
71893884|NCT03119649|143309821|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|2.11||0.594|TWO_SIDED|95.0|-3.1|5.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||5.4|-3.1|0.5940
71893885|NCT03119649|143309821|SUPERIORITY||Difference in LS Means|0.6|STANDARD_ERROR_OF_MEAN|2.06||0.7553|TWO_SIDED|95.0|-3.5|4.8||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||4.8|-3.5|0.7553
71802233|NCT01163682|143104115|NON_INFERIORITY|This tests determined the odds of an increase of greater than or equal to 5 points on the FACT-NTX scale, from baseline to 16 weeks, among those in the intervention arm (electo-acupuncture), compared to those in the control arm (sham acupuncture). This change was considered to be clinically meaningful.|Odds Ratio (OR)|1.25||||0.09|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||||1.62|0.97|0.09
71802234|NCT00359762|143104117|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if \<1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. If CI excludes 1, the hypothesis that the risk of treatment failure with Exenatide is equal to that with Glimepiride is rejected.|Hazard Ratio|0.748||||0.002|TWO_SIDED|95.0|0.623|0.899|||Regression, Cox|Time to treatment failure was modeled using Cox regression with treatment and baseline HbA1c as predictive terms.||The null hypothesis (H0) and alternative hypothesis (H1) for the primary analysis (i.e., non-inferiority) are:H0: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \>=1.25.H1: hazards of treatment for Exenatide/hazards of treatment for Glimepiride \< 1.25. With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.||0.899|0.623|0.0020
71802235|NCT00359762|143104118|SUPERIORITY_OR_OTHER|||||||0.0315|TWO_SIDED|99.95|||||Log Rank|||Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.||||0.0315
71802236|NCT00359762|143104119|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|5.56||0.7648|TWO_SIDED|95.0|-12.58|9.25|||Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||9.25|-12.58|0.7648
71802237|NCT00359762|143104120|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.35|STANDARD_ERROR_OF_MEAN|7.399||0.0528|TWO_SIDED|95.0|-28.88|0.17|||ANCOVA|||Change in HOMA-B from baseline to endpoint was analyzed by an analysis of covariance (ANCOVA) model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.17|-28.88|0.0528
71802238|NCT00359762|143104121|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.904|TWO_SIDED|95.0|-0.07|0.06|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.06|-0.07|0.9040
71802239|NCT00359762|143104122|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.017||0.25|TWO_SIDED|95.0|-0.05|0.01|||ANCOVA|||Change in fasting proinsulin/insulin ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||0.01|-0.05|0.2500
71802240|NCT00359762|143104123|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|4.497||0.9001|TWO_SIDED|95.0|-9.4|8.27|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||8.27|-9.40|0.9001
71802241|NCT00359762|143104124|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|11.19|STANDARD_ERROR_OF_MEAN|4.966||0.0246|TWO_SIDED|95.0|1.44|20.95|||ANCOVA|||Change in DI30/DG30 ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||20.95|1.44|0.0246
71802242|NCT00359762|143104125|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.67|STANDARD_ERROR_OF_MEAN|1.598||0.0036|TWO_SIDED|95.0|1.53|7.81|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||7.81|1.53|0.0036
71802243|NCT00359762|143104126|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|7.33|STANDARD_ERROR_OF_MEAN|2.128||0.0006|TWO_SIDED|95.0|3.15|11.5|||ANCOVA|||Change in disposition index from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||11.50|3.15|0.0006
71841037|NCT04800211|143191011|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-39.501||||0.025|TWO_SIDED|95.0|-75.396|-3.605|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-3.605|-75.396|0.0250
71841038|NCT04800211|143191011|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.94||||0.9997|TWO_SIDED|95.0|-37.896|32.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 8-epi-prostaglandin F2alpha (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||32.016|-37.896|0.9997
71893886|NCT03119649|143309821|SUPERIORITY||Difference in LS Means|1.0|STANDARD_ERROR_OF_MEAN|1.94||0.5958|TWO_SIDED|95.0|-2.9|4.9||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||4.9|-2.9|0.5958
71675281|NCT01908829|142868062|SUPERIORITY||Rate Ratio|0.83|STANDARD_ERROR_OF_MEAN|0.09|=|0.038|TWO_SIDED|95.0|0.69|0.99||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.99|0.69|=0.038
71802244|NCT00359762|143104127|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0128|TWO_SIDED|95.0|-0.31|-0.04|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.04|-0.31|0.0128
71802245|NCT00359762|143104128|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.0015|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.||-0.06|-0.26|0.0015
71802246|NCT00359762|143104129|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.174|<|0.0001|TWO_SIDED|95.0|-1.03|-0.34|||Mixed Models Analysis|||MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.34|-1.03|<.0001
71802247|NCT00359762|143104130|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.183||0.0109|TWO_SIDED|95.0|-0.83|-0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-0.11|-0.83|0.0109
71802248|NCT00359762|143104131|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.424|<|0.0001|TWO_SIDED|95.0|-3.64|-1.97|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-1.97|-3.64|<.0001
71802249|NCT00359762|143104132|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.327|<|0.0001|TWO_SIDED|95.0|-2.84|-1.55|||ANCOVA|||Change in postprandial (2 hours) plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (\<=7.3%, \>7.3% to \<=8.2%, \>8.2%) as factors and baseline value as a covariate.||-1.55|-2.84|<.0001
71802250|NCT00359762|143104133|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|0.463|<|0.0001|TWO_SIDED|95.0|-6.31|-4.49|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.||-4.49|-6.31|<.0001
71802251|NCT00359762|143104134|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|1.228|<|0.0001|TWO_SIDED|95.0|-7.61|-2.79|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-2.79|-7.61|<.0001
71802252|NCT00359762|143104135|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.75||0.0228|TWO_SIDED|95.0|-3.18|-0.24|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.24|-3.18|0.0228
71802253|NCT00359762|143104136|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.805||0.3737|TWO_SIDED|95.0|-2.3|0.86|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.86|-2.30|0.3737
71802254|NCT00359762|143104137|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.089||0.0042|TWO_SIDED|95.0|-0.43|-0.08|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||-0.08|-0.43|0.0042
71802255|NCT00359762|143104138|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.079||0.7914|TWO_SIDED|95.0|-0.13|0.18|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.18|-0.13|0.7914
71802256|NCT00359762|143104139|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.019||0.0011|TWO_SIDED|95.0|0.02|0.1|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.||0.10|0.02|0.0011
71802257|NCT00359762|143104140|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.22|0.37|||Negative Binomial Model|||The number of hypoglycemic episodes by patient were compared between treatment groups using a negative binomial model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||0.37|0.22|<.0001
71802258|NCT00359762|143104141|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.141||0.0508|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.||0.55|-0.00|0.0508
71802259|NCT02652780|143104152|SUPERIORITY||Mean Difference (Net)|-0.008||||0.8783|TWO_SIDED|95.0|-0.119|0.102|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.||0.102|-0.119|0.8783
71814052|NCT02696564|143130146|SUPERIORITY|We will estimate a 95% confidence interval for the losartan vs placebo mean difference, using the regression estimate and the t-distribution; we will reject the null that losartan is equivalent to placebo if the 95% interval excludes 0.0.||||||0.133|||||||Mixed Models Analysis|P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.||||||0.133
71814053|NCT02696564|143130147|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.762||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.762
71802260|NCT01172938|143104164|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.0||||0.0001|TWO_SIDED|95.0|9.7|28.3|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||28.3|9.7|0.0001
71802261|NCT01172938|143104164|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3||||0.0166|TWO_SIDED|95.0|2.2|20.4|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||20.4|2.2|0.0166
71802262|NCT01172938|143104165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.159||||0.0017|TWO_SIDED|95.0|-0.258|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.060|-0.258|0.0017
71802263|NCT01172938|143104165|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.113||||0.0252|TWO_SIDED|95.0|-0.211|-0.014|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.014|-0.211|0.0252
71802264|NCT01172938|143104166|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.2|||<|0.0001|TWO_SIDED|95.0|13.4|30.9||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||30.9|13.4|<0.0001
71802265|NCT01172938|143104166|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4||||0.0038|TWO_SIDED|95.0|4.2|20.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||20.7|4.2|0.0038
71802266|NCT01172938|143104167|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.182||||0.0005|TWO_SIDED|95.0|-0.283|-0.08||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.080|-0.283|0.0005
71802267|NCT01172938|143104167|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.135||||0.0091|TWO_SIDED|95.0|-0.236|-0.034||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-0.034|-0.236|0.0091
71814054|NCT02696564|143130148|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.834||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.834
71814055|NCT02696564|143130149|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.783||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.783
71893887|NCT03119649|143309821|SUPERIORITY||Difference in LS Means|2.3|STANDARD_ERROR_OF_MEAN|1.94||0.2403|TWO_SIDED|95.0|-1.6|6.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||6.2|-1.6|0.2403
71814056|NCT02696564|143130150|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.053||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.053
71814057|NCT02696564|143130151|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.016||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.016
71814058|NCT02696564|143130152|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.065||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.065
71802268|NCT01172938|143104168|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.42||||0.0056|TWO_SIDED|95.0|0.71|4.13||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||4.13|0.71|0.0056
71802269|NCT01172938|143104168|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.7||||0.0504|TWO_SIDED|95.0|0.0|3.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||3.40|-0.00|0.0504
71814059|NCT02696564|143130153|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.293||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.293
71814060|NCT02696564|143130154|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.356||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.356
71814061|NCT02696564|143130155|SUPERIORITY|Statistical differences were inferred if the 95% confidence intervals (CI) did not include zero.||||||0.009||||||P-value based on generalized linear mixed models with covariates for site, baseline value, and for treatment group.|Mixed Models Analysis|||||||0.009
71814062|NCT02696564|143130156|SUPERIORITY||Relative rate (losartan to placebo)|0.8||||0.892|TWO_SIDED|95.0|0.03|18.77|||Negative binomial model|||P-value for rate of mild exacerbations between treatment groups (measured in events per 100 person-years).||18.77|0.03|0.892
71814063|NCT02696564|143130156|SUPERIORITY||Relative rate (losartan to placebo)|0.91||||0.946|TWO_SIDED|95.0|0.05|14.97|||Negative binomial model|||P-value for rate of moderate exacerbations between treatment groups (measured in events per 100 person-years).||14.97|0.05|0.946
71814064|NCT02696564|143130156|SUPERIORITY||Relative rate (losartan to placebo)|0.36||||0.487|TWO_SIDED|95.0|0.02|6.51|||Negative binomial model|||P-value for rate of severe exacerbations between treatment groups (measured in events per 100 person-years).||6.51|0.02|0.487
71814065|NCT00615264|143130162|SUPERIORITY_OR_OTHER|||||||0.2851|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.2851
71814066|NCT00615264|143130163|SUPERIORITY_OR_OTHER|||||||0.769|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix||||||0.7690
71814067|NCT01187914|143130164|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.48||95.0|||||Regression, Linear|||||||0.48
71814068|NCT02287584|143130171|SUPERIORITY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|2.04||0.007|TWO_SIDED|95.0|-9.6|-1.6||adjusted p value, Hochberg procedure|Mixed Models Analysis|||Using Mixed Model for Repeated Measures||-1.6|-9.6|0.007
71814069|NCT02287584|143130171|SUPERIORITY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-14.4|-6.4||adjusted p-value, Hochberg procedure|Mixed Models Analysis|||||-6.4|-14.4|<0.001
71814070|NCT02884414|143130211|OTHER|Paired Student's t-test.||||||0.44|||||||t-test, 2 sided|||||||0.44
71814071|NCT02798211|143130218|SUPERIORITY||Odds Ratio (OR)|3.51||||0.0011|TWO_SIDED|95.0|1.65|7.45|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||7.45|1.65|0.0011
71814072|NCT02798211|143130218|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0961|TWO_SIDED|95.0|0.89|4.15|||Regression, Logistic|Statistical analysis (logistic regression) of ACR20 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||4.15|0.89|0.0961
71814073|NCT02798211|143130219|SUPERIORITY||Odds Ratio (OR)|0.6||||0.333|TWO_SIDED|95.0|0.22|1.68|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, 16 weeks||1.68|0.22|0.3330
71814074|NCT02798211|143130219|SUPERIORITY||Odds Ratio (OR)|0.4||||0.0841|TWO_SIDED|95.0|0.14|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of dactylitis in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, 16 weeks||1.13|0.14|0.0841
71814075|NCT02798211|143130220|SUPERIORITY||Odds Ratio (OR)|0.52||||0.1618|TWO_SIDED|95.0|0.21|1.3|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||1.30|0.21|0.1618
71814076|NCT02798211|143130220|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0898|TWO_SIDED|95.0|0.19|1.13|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||1.13|0.19|0.0898
71814077|NCT02798211|143130221|SUPERIORITY||Odds Ratio (OR)|0.27||||0.0125|TWO_SIDED|95.0|0.09|0.75|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.75|0.09|0.0125
71814078|NCT02798211|143130221|SUPERIORITY||Odds Ratio (OR)|0.25||||0.0086|TWO_SIDED|95.0|0.09|0.7|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.70|0.09|0.0086
71814079|NCT02798211|143130222|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0338|TWO_SIDED|95.0|0.13|0.92|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, 16 weeks||0.92|0.13|0.0338
71814080|NCT02798211|143130222|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0359|TWO_SIDED|95.0|0.14|0.93|||Regression, Logistic|Statistical analysis (logistic regression) of presence of enthesitis (SPARCC and LEI) in treatment period 1 (non-responder imputation)||secukinumab 150mg s.c. injection, 16 weeks||0.93|0.14|0.0359
71814081|NCT02798211|143130223|SUPERIORITY||Odds Ratio, log|6.3||||0.0038|TWO_SIDED|95.0|1.81|21.88|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||21.88|1.81|0.0038
71841039|NCT04800211|143191012|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-54.398||||0.6778|TWO_SIDED|95.0|-177.281|68.485|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||68.485|-177.281|0.6778
71802270|NCT01172938|143104169|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0017|TWO_SIDED|95.0|6.6|26.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.6|0.0017
71893888|NCT03119649|143309822|SUPERIORITY||Difference in LS Means|2.7|STANDARD_ERROR_OF_MEAN|4.81||0.5749|TWO_SIDED|95.0|-6.9|12.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo||12.4|-6.9|0.5749
71893889|NCT03119649|143309822|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.83||0.7381|TWO_SIDED|95.0|-8.1|11.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo||11.3|-8.1|0.7381
71893890|NCT03119649|143309822|SUPERIORITY||Difference in LS Means|6.8|STANDARD_ERROR_OF_MEAN|4.43||0.1282|TWO_SIDED|95.0|-2.0|15.7||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo||15.7|-2.0|0.1282
71893891|NCT03119649|143309822|SUPERIORITY||Difference in LS Means|1.6|STANDARD_ERROR_OF_MEAN|4.43||0.7212|TWO_SIDED|95.0|-7.3|10.5||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo||10.5|-7.3|0.7212
71893892|NCT02333227|143309827|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
71893893|NCT02333227|143309828|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Co-primary outcomes|We employed generalized linear mixed methods (GLMM) with binomial distribution to examine the association between study primary outcomes of baby's birth weight (\<2500) and gestational age at delivery (\<37 weeks including up to 36 and 6/7 weeks) and assignment to the study intervention group. To account for clustering of outcomes by cluster (sites), we used random slope/random intercept GLMM models with a cluster as a random effect (level 2) and treatment as a fixed effect (level 1), since random effect modeling is an individual-level analyses that accounts for within-cluster dependence by maximum likelihood estimation. A separate model was fit to each study outcome and corresponding relative risk with 95% confidence intervals (CI) estimated. Full information maximum likelihood estimation (FIML) allows for analyses to be performed with the full sample, under conditions of Missing Completely at Random (MCAR) and Missing at Random (MAR), and with missing data rates up to 50%.|||<0.05
71893894|NCT02333227|143309829|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71893895|NCT02333227|143309830|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis||||Specifically, the composite of periodontal disease was also created; this composite was positive if any of the following were detected: gingival bleeding, pockets of 4 mm or greater, or loss of attachment of 4 mm or greater. A scaled periodontal disease score was also created which was the sum of scores for gingival bleeding (+1 if bleeding was present, per tooth), gingival pockets (+1 for pockets of 4-5 mm and +2 for 6 mm or deeper, per tooth), and loss of attachment (+1 for 4-5 mm loss, +2 for 6-8 mm, +3 for 9-11 mm, and +4 for 12 mm or more, per tooth with values recorded for index teeth) divided by the number of teeth present.|||<0.05
71893896|NCT02333227|143309831|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71893897|NCT01624194|143309839|OTHER|||||||0.0275|||||||General Linear Model (GLM)|||||||0.0275
71675282|NCT01908829|142868062|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.09|=|0.022|TWO_SIDED|95.0|0.69|0.97||p\<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.||0.97|0.69|=0.022
71802271|NCT01172938|143104169|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-1.2|18.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||18.9|-1.2|
71893898|NCT01624194|143309840|OTHER||||||>|0.05||||||Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.|Fisher Exact|||||||>0.05
71893899|NCT01624194|143309841|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
71893900|NCT01624194|143309844|OTHER|||||||0.3395|||||||General Linear Model (GLM)|||||||0.3395
71893901|NCT01624194|143309852|OTHER|||||||0.9757|||||||General Linear Model (GLM)|||||||0.9757
71893902|NCT01624194|143309853|OTHER||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.||||||>0.05
71893903|NCT01624194|143309854|OTHER||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71893904|NCT01624194|143309855|OTHER||||||>|0.05||||||For all blood pressure analyses.|Mixed Models Analysis|||||||>0.05
71893905|NCT03528681|143309935|OTHER||Back-transformed mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.902|0.959|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.959|0.902|<0.001
71802272|NCT01172938|143104170|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.9||||0.0023|TWO_SIDED|95.0|-12.9|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||||-2.8|-12.9|0.0023
71802273|NCT01172938|143104170|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.8|||||TWO_SIDED|95.0|-10.8|-0.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.7|-10.8|
71802274|NCT01172938|143104171|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-1.2|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.2|
71802275|NCT01172938|143104171|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
71802276|NCT01172938|143104172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|||||TWO_SIDED|95.0|-1.1|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.4|-1.1|
71802277|NCT01172938|143104172|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.3|
71802278|NCT01172938|143104173|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.88|||||TWO_SIDED|95.0|-7.41|-2.34|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.34|-7.41|
71802279|NCT01172938|143104173|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.39|||||TWO_SIDED|95.0|-6.92|-1.86|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.86|-6.92|
71802280|NCT01172938|143104174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-0.76|-0.31|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.31|-0.76|
71802281|NCT01172938|143104174|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|||||TWO_SIDED|95.0|-0.7|-0.25|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.25|-0.70|
71802282|NCT01172938|143104175|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.33|||||TWO_SIDED|95.0|0.43|4.23|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.23|0.43|
71802283|NCT01172938|143104175|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|||||TWO_SIDED|95.0|-1.77|2.03|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.03|-1.77|
71802284|NCT01172938|143104176|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.56|||||TWO_SIDED|95.0|1.72|5.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||5.40|1.72|
71802285|NCT01172938|143104176|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.04|||||TWO_SIDED|95.0|0.21|3.88|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||3.88|0.21|
71893906|NCT03528681|143309935|OTHER||Back-transformed mean difference|0.85|||<|0.001|TWO_SIDED|95.0|0.825|0.876|||Mixed Models Analysis|||Results are derived from a longitudinal model applied to log-transformed S-K measurements adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates. The back-transformation is to the original scale of the S-K measurement||0.876|0.825|<0.001
71893907|NCT03528681|143309940|OTHER|The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|3.8|||<|0.001|TWO_SIDED|95.0|2.17|6.67|||Mixed Models Analysis|||||6.67|2.17|<0.001
71893908|NCT03528681|143309940|OTHER||Odds Ratio (OR)|11.63|||<|0.001|TWO_SIDED|95.0|6.45|21.0|||Mixed Models Analysis|||The analysis uses a generalized mixed model which includes a random intercept and logit link. The model includes all S-K data values collected at the scheduled visits between Days 8-29, dichotomized as normal and abnormal, as response variables, and baseline covariates. Placebo is the reference group.||21.00|6.45|<0.001
71893909|NCT03528681|143309941|OTHER|The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.|Odds Ratio (OR)|2.54||||0.035|TWO_SIDED|95.0|1.07|6.05|||Regression, Logistic|||||6.05|1.07|0.035
71893910|NCT03528681|143309941|OTHER||Odds Ratio (OR)|6.25|||<|0.001|TWO_SIDED|95.0|2.56|15.27|||Regression, Logistic|||The model included normokalaemia status (yes, no) on Day 29 as binary response variables, and baseline covariates. Placebo is the reference group.||15.27|2.56|<0.001
71802286|NCT01172938|143104177|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|24.6|||||TWO_SIDED|95.0|15.2|34.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||34.0|15.2|
71802287|NCT01172938|143104177|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|12.4|||||TWO_SIDED|95.0|3.4|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|3.4|
71841040|NCT04800211|143191012|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-48.395||||0.7497|TWO_SIDED|95.0|-168.697|71.908|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine 11-dehydrothromboxane B2 (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||71.908|-168.697|0.7497
71841041|NCT04800211|143191013|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-20.01||||0.0003|TWO_SIDED|95.0|-32.447|-7.573|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-7.573|-32.447|0.0003
71841042|NCT04800211|143191013|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-22.566|||<|0.0001|TWO_SIDED|95.0|-34.837|-10.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Plasma sICAM-1 (ng/mL) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-10.295|-34.837|<.0001
71841043|NCT04800211|143191014|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-179.365|||<|0.0001|TWO_SIDED|95.0|-225.708|-133.022|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-133.022|-225.708|<.0001
71893911|NCT03528681|143309942|OTHER||Median Difference (Final Values)|5.72|||<|0.001|TWO_SIDED|95.0|3.13|8.31|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||8.31|3.13|<0.001
71893912|NCT03528681|143309942|OTHER||Mean Difference (Final Values)|11.14|||<|0.001|TWO_SIDED|95.0|8.57|13.71|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||13.71|8.57|<0.001
71802288|NCT01172938|143104178|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-10.6|||||TWO_SIDED|95.0|-15.4|-5.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-5.7|-15.4|
71802289|NCT01172938|143104178|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-7.1|||||TWO_SIDED|95.0|-12.0|-2.2|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-2.2|-12.0|
71802290|NCT01172938|143104179|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|||||TWO_SIDED|95.0|-1.6|0.0|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.0|-1.6|
71802291|NCT01172938|143104179|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|-0.8|||||TWO_SIDED|95.0|-1.6|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.6|
71802292|NCT01172938|143104180|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.2|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.3|-1.2|
71802293|NCT01172938|143104180|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||0.1|-1.5|
71893913|NCT03528681|143309945|OTHER||Mean Difference (Final Values)|-105.248|||<|0.001|TWO_SIDED|95.0|-161.293|-49.203|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-49.203|-161.293|<0.001
71893914|NCT03528681|143309945|OTHER||Median Difference (Final Values)|-137.267|||<|0.001|TWO_SIDED|95.0|-192.596|-81.937|||Mixed Models Analysis|||S-Aldo Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||-81.937|-192.596|<0.001
71893915|NCT03528681|143309945|OTHER||Mean Difference (Final Values)|0.014||||0.839|TWO_SIDED|95.0|-0.12|0.147|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.147|-0.120|0.839
71893916|NCT03528681|143309945|OTHER||Mean Difference (Final Values)|-0.062||||0.355|TWO_SIDED|95.0|-0.195|0.07|||Mixed Models Analysis|||P-Renin Results derived from a longitudinal mixed model adjusted for treatment, visit, treatment-by-visit interaction and baseline covariates||0.070|-0.195|0.355
71802294|NCT01172938|143104181|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-6.38|||||TWO_SIDED|95.0|-9.0|-3.75|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-3.75|-9.00|
71802295|NCT01172938|143104181|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-4.41|||||TWO_SIDED|95.0|-7.03|-1.79|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-1.79|-7.03|
71802296|NCT01172938|143104182|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|||||TWO_SIDED|95.0|-0.94|-0.46|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.46|-0.94|
71802297|NCT01172938|143104182|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|||||TWO_SIDED|95.0|-0.7|-0.22|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||-0.22|-0.70|
71802298|NCT01172938|143104183|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|2.21|||||TWO_SIDED|95.0|0.32|4.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||4.10|0.32|
71802299|NCT01172938|143104183|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|0.4|||||TWO_SIDED|95.0|-1.5|2.29|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||2.29|-1.50|
71802300|NCT01172938|143104184|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.3|||||TWO_SIDED|95.0|-10.1|16.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.7|-10.1|
71802301|NCT01172938|143104184|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.3|||||TWO_SIDED|95.0|-6.5|21.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.1|-6.5|
71802302|NCT01172938|143104185|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.9|||||TWO_SIDED|95.0|-13.4|19.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.3|-13.4|
71802303|NCT01172938|143104185|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-9.1|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-9.1|
71802304|NCT01172938|143104186|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|19.2|||||TWO_SIDED|95.0|9.0|29.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||29.3|9.0|
71802305|NCT01172938|143104186|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.6|||||TWO_SIDED|95.0|6.4|26.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.8|6.4|
71893917|NCT03528681|143309947|OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.27|0.57|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.57|0.27|<0.001
71893918|NCT03528681|143309947|OTHER||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.25|||Regression, Cox|||The model included time to reoccurrence of hyperkalaemia as response variable (event: hyperkalaemia or discontinue treatment in RTP due to high S-K levels), baseline eGFR, OLP and RTP baseline S-K values as well as age (\< 55, 55-64, \> 64 years) and baseline binary indicators for RAASi, chronic kidney disease, heart failure, and diabetes mellitus as covariates. Placebo is the reference group||0.25|0.10|<0.001
71893919|NCT02907944|143309994|SUPERIORITY||Odds Ratio (OR)|1.09||||0.55|TWO_SIDED|95.0|0.82|1.45|||Generalized Estimating Equation|||||1.45|0.82|0.55
71893920|NCT02907944|143309994|SUPERIORITY||Odds Ratio (OR)|1.76||||0.09|TWO_SIDED|95.0|0.92|3.37|||Generalized Estimating Equation|||||3.37|0.92|0.09
71893921|NCT02907944|143309994|SUPERIORITY||Odds Ratio (OR)|1.4||||0.001|TWO_SIDED|95.0|1.14|1.71|||Generalized Estimating Equation|||||1.71|1.14|0.001
71893922|NCT02907944|143309995|SUPERIORITY||Odds Ratio (OR)|1.08||||0.59|TWO_SIDED|95.0|0.81|1.45|||Generalized Estimating Equation|||||1.45|0.81|0.59
71893923|NCT02907944|143309995|SUPERIORITY||Odds Ratio (OR)|1.77||||0.11|TWO_SIDED|95.0|0.88|3.55|||Generalized Estimating Equation|||||3.55|0.88|0.11
71893924|NCT02907944|143309995|SUPERIORITY||Odds Ratio (OR)|1.35||||0.005|TWO_SIDED|95.0|1.09|1.66|||Generalized Estimating Equation|||||1.66|1.09|0.005
71893925|NCT03715465|143310009|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
71893926|NCT03715465|143310010|SUPERIORITY|||||||0.411|||||||t-test, 2 sided|||Per diary||||0.411
71893927|NCT03715465|143310010|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Per wrist actigraphy||||0.920
71893928|NCT03715465|143310011|SUPERIORITY|||||||0.787|||||||t-test, 2 sided|||Per diary||||0.787
71841044|NCT04800211|143191014|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-153.22|||<|0.0001|TWO_SIDED|95.0|-198.93|-107.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Total NNAL (ng/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-107.509|-198.930|<.0001
71675283|NCT01908829|142868063|SUPERIORITY||LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.13|=|0.001|TWO_SIDED|95.0|-0.72|-0.19||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.19|-0.72|=0.001
71802306|NCT01172938|143104187|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|13.2|||||TWO_SIDED|95.0|-0.1|26.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.5|-0.1|
71802307|NCT01172938|143104187|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.3|||||TWO_SIDED|95.0|-2.4|25.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||25.0|-2.4|
71802308|NCT01172938|143104188|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.9|||||TWO_SIDED|95.0|-6.8|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.6|-6.8|
71802309|NCT01172938|143104188|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.7|||||TWO_SIDED|95.0|-8.7|24.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||24.2|-8.7|
71802310|NCT01172938|143104189|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|26.3|||||TWO_SIDED|95.0|17.1|35.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||35.5|17.1|
71802311|NCT01172938|143104189|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.2|||||TWO_SIDED|95.0|5.4|23.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.1|5.4|
71802312|NCT01172938|143104190|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.3|||||TWO_SIDED|95.0|3.7|16.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.8|3.7|
71802313|NCT01172938|143104190|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|3.0|16.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.0|3.0|
71802314|NCT01172938|143104191|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|3.1|||||TWO_SIDED|95.0|-0.4|6.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||6.5|-0.4|
71802315|NCT01172938|143104191|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.8|||||TWO_SIDED|95.0|0.8|8.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.7|0.8|
71802316|NCT01172938|143104192|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|14.9|||||TWO_SIDED|95.0|8.3|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||21.5|8.3|
71802317|NCT01172938|143104192|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|10.1|||||TWO_SIDED|95.0|4.0|16.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||16.1|4.0|
71802318|NCT01172938|143104193|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.5|||||TWO_SIDED|95.0|4.8|14.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.2|4.8|
71802319|NCT01172938|143104193|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|4.7|||||TWO_SIDED|95.0|1.2|8.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||8.3|1.2|
71893929|NCT03715465|143310011|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Per wrist actigraphy||||0.916
71893930|NCT03715465|143310012|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|||Per diary||||0.270
71893931|NCT03715465|143310012|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||Per wrist actigraphy||||0.406
71893932|NCT03715465|143310013|SUPERIORITY|||||||0.635|||||||t-test, 2 sided|||Per diary||||0.635
71893933|NCT03715465|143310013|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||Per wrist actigraphy||||0.383
71841045|NCT04800211|143191015|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.569|||<|0.0001|TWO_SIDED|95.0|-3.084|-2.054|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.054|-3.084|<.0001
71893934|NCT03715465|143310014|SUPERIORITY|||||||0.456|||||||t-test, 2 sided|||||||0.456
71893935|NCT03715465|143310015|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||||||0.402
71893936|NCT03715465|143310016|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71893937|NCT03715465|143310017|SUPERIORITY|||||||0.525|||||||t-test, 2 sided|||||||0.525
71893938|NCT03715465|143310018|SUPERIORITY|||||||0.106|||||||t-test, 2 sided|||||||0.106
71893939|NCT03715465|143310019|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
71893940|NCT03715465|143310020|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71893941|NCT03715465|143310021|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||||||0.246
71893942|NCT03715465|143310022|SUPERIORITY|||||||0.333|||||||t-test, 2 sided|||||||0.333
71893943|NCT04902885|143310024|SUPERIORITY|||||||0.0003|||||||non-parametric ANCOVA|||70 subjects (35 per group) provided approximately 95% power at the test level of α = 0.05 (2-sided) .Assuming a dropout rate of approximately 12%, the sample size for Part II was 80 subjects (40 per group)||||0.0003
71893944|NCT00756002|143310041|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||<0.001
71893945|NCT00756002|143310042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893946|NCT00756002|143310043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893947|NCT00756002|143310044|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.||||0.003
71893948|NCT00756002|143310045|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893949|NCT00756002|143310046|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893950|NCT00756002|143310047|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893951|NCT00756002|143310048|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893952|NCT00756002|143310049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893953|NCT00756002|143310050|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893954|NCT00756002|143310051|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893955|NCT00756002|143310052|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893956|NCT00756002|143310053|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||<0.001
71893957|NCT00756002|143310054|SUPERIORITY_OR_OTHER|||||||0.043||95.0||||LS means from ANCOVA model with effects for treatment \& pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|||||||0.043
71893958|NCT00756002|143310055|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
71802320|NCT01172938|143104194|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|7.6|||||TWO_SIDED|95.0|-2.8|17.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||17.9|-2.8|
71802321|NCT01172938|143104194|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|11.9|||||TWO_SIDED|95.0|0.8|23.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||23.0|0.8|
71802322|NCT01172938|143104195|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-1.4|||||TWO_SIDED|95.0|-17.7|14.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||14.8|-17.7|
71802323|NCT01172938|143104195|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|2.4|||||TWO_SIDED|95.0|-14.8|19.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||19.6|-14.8|
71802324|NCT01172938|143104196|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|17.4|||||TWO_SIDED|95.0|6.6|28.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||28.2|6.6|
71802325|NCT01172938|143104196|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.8|||||TWO_SIDED|95.0|5.6|27.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||27.9|5.6|
71802326|NCT01172938|143104197|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|5.8|||||TWO_SIDED|95.0|-10.7|22.4|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||22.4|-10.7|
71802327|NCT01172938|143104197|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|8.8|||||TWO_SIDED|95.0|-8.5|26.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|||26.2|-8.5|
71802328|NCT04188041|143104220|OTHER|see above||||||0.02|||||||Wilcoxon signed rank test|||Non-parametric Wilcoxon signed rank test for paired data was used to test for significant change in confidence.||||0.02
71802329|NCT04808609|143104234|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|1.63||0.77|TWO_SIDED|95.0|0.24|6.76|||Fisher Exact|||||6.76|0.24|0.77
71893959|NCT00756002|143310056|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.010
71802330|NCT04808609|143104235|OTHER|feasibility test|Risk Ratio (RR)|1.27|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED|95.0|0.43|3.78|||Chi-squared|||||3.78|0.43|0.66
71802331|NCT04808609|143104236|OTHER|feasibility test|Cohen's D|0.21|STANDARD_ERROR_OF_MEAN|0.33||0.59|TWO_SIDED|95.0|-0.44|0.86|||t-test, 2 sided|||||0.86|-0.44|0.59
71802332|NCT04808609|143104236|OTHER|feasibility|Cohen's D|0.41|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|0.07|0.74|||t-test, 1 sided|||Results from Paired T-Test assessing the with-subject time effect on exhaled CO in ppm from baseline to 12 weeks||0.74|0.07|0.02
71802333|NCT04808609|143104237|OTHER|feasibility test|Cohen's D|0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.46|0.78|||t-test, 2 sided|||||0.78|-0.46|0.61
71802334|NCT04808609|143104238|OTHER|feasibility test|Cohen's D|0.19|STANDARD_ERROR_OF_MEAN|0.31||0.55|TWO_SIDED|95.0|-0.42|0.8|||t-test, 2 sided|||||0.80|-0.42|0.55
71802335|NCT04808609|143104239|OTHER|feasibility test|Cohen's D|0.004|STANDARD_ERROR_OF_MEAN|0.31||0.99|TWO_SIDED|95.0|-0.61|0.62|||t-test, 2 sided|||||0.62|-0.61|0.99
71802336|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.6|||||TWO_SIDED|95.0|-12.1|-5.1||||||Serotype 1: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-5.1|-12.1|
71802337|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-15.5|||||TWO_SIDED|95.0|-20.1|-10.8||||||Serotype 3: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-10.8|-20.1|
71802338|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-8.4|||||TWO_SIDED|95.0|-12.0|-4.9||||||Serotype 4: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.9|-12.0|
71802339|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.3|||||TWO_SIDED|95.0|-7.8|-0.8||||||Serotype 5: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.8|-7.8|
71893960|NCT00756002|143310057|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.002
71893961|NCT00756002|143310058|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.006
71893962|NCT00756002|143310059|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
71893963|NCT00756002|143310060|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
71893964|NCT00756002|143310061|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.||||||<0.001
71893965|NCT00756002|143310062|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893966|NCT00756002|143310063|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71802340|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-2.4|||||TWO_SIDED|95.0|-4.6|-0.2||||||Serotype 6A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-0.2|-4.6|
71802341|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-4.1|||||TWO_SIDED|95.0|-7.0|-1.2||||||Serotype 6B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-1.2|-7.0|
71802342|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.7|0.7||||||Serotype 7F: 2-sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.7|-2.7|
71802343|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.9|||||TWO_SIDED|95.0|-11.3|-4.6||||||Serotype 9V: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-4.6|-11.3|
71802344|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.8|||||TWO_SIDED|95.0|-3.1|1.6||||||Serotype 14: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.6|-3.1|
71802345|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-0.6|||||TWO_SIDED|95.0|-3.1|1.9||||||Serotype 18C: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||1.9|-3.1|
71802346|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-1.0|||||TWO_SIDED|95.0|-2.6|0.5||||||Serotype 19A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.5|-2.6|
71802347|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|0.2|||||TWO_SIDED|95.0|-1.5|2.0||||||Serotype 19F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||2.0|-1.5|
71802348|NCT04382326|143104253|NON_INFERIORITY|Comparison was conducted for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|percentage difference|-7.6|||||TWO_SIDED|95.0|-11.4|-3.9||||||Serotype 23F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-3.9|-11.4|
71893967|NCT00756002|143310064|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893968|NCT00756002|143310065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893969|NCT00756002|143310066|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893970|NCT00756002|143310067|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||<0.001
71893971|NCT00756002|143310068|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.785
71893972|NCT00756002|143310069|SUPERIORITY_OR_OTHER|||||||0.422||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.422
71893973|NCT00756002|143310070|SUPERIORITY_OR_OTHER|||||||0.665||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.665
71893974|NCT00756002|143310071|SUPERIORITY_OR_OTHER|||||||0.228||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.228
71893975|NCT00756002|143310072|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.099
71802349|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|11.2|||||TWO_SIDED|95.0|8.6|14.0||||||Serotype 8: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||14.0|8.6|
71893976|NCT00756002|143310073|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.005
71893977|NCT00756002|143310074|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
71893978|NCT00756002|143310075|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.001
71893979|NCT00756002|143310076|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.004
71893980|NCT00756002|143310077|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.040
71802350|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-3.3|||||TWO_SIDED|95.0|-6.9|0.3||||||Serotype 10A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||0.3|-6.9|
71802351|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|7.1||||||95.0|4.2|10.2||||||Serotype 11A: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||10.2|4.2|
71802352|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|-18.1|||||TWO_SIDED|95.0|-22.1|-14.0||||||Serotype 12F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||-14.0|-22.1|
71893981|NCT00756002|143310078|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.814
71893982|NCT00756002|143310079|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.929
71893983|NCT00756002|143310080|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.591
71893984|NCT00756002|143310081|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.015
71802353|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.7|||||TWO_SIDED|95.0|10.2|15.4||||||Serotype 15B: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.4|10.2|
71802354|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|12.8|||||TWO_SIDED|95.0|10.3|15.5||||||Serotype 22F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||15.5|10.3|
71802355|NCT04382326|143104253|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|percentage difference|1.1|||||TWO_SIDED|95.0|-2.2|4.5||||||Serotype 33F: 2-Sided CI were calculated based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage||4.5|-2.2|
71802356|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69|||||TWO_SIDED|95.0|0.63|0.76||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.63|
71802357|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.61|0.73||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.73|0.61|
71802358|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.78||||||95.0|0.7|0.86||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.70|
71893985|NCT00756002|143310082|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.097
71893986|NCT00756002|143310083|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.028
71893987|NCT00756002|143310084|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.003
71893988|NCT00756002|143310085|SUPERIORITY_OR_OTHER|||||||0.111||95.0||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||||||0.111
71893989|NCT03047005|143310091|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.07|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.07
71893990|NCT03047005|143310092|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.01|||||||Mixed Models Analysis|Analyses were performed for all randomized patients who attended the first treatment session. Model adjusted for stage 1 treatment condition.||||||.01
71893991|NCT04899271|143310097|SUPERIORITY|||||||0.807|||||||Chi-squared|||||||0.807
71893992|NCT04899271|143310098|SUPERIORITY|||||||0.746|||||||Chi-squared|||Comparison at month 6||||0.746
71893993|NCT04899271|143310098|SUPERIORITY|||||||0.201|||||||Chi-squared|||Comparison at month 18||||0.201
71893994|NCT04899271|143310099|SUPERIORITY|||||||0.867|||||||Chi-squared|||Comparison at month 6||||0.867
71893995|NCT04899271|143310099|SUPERIORITY|||||||0.769|||||||Chi-squared|||Comparison at month 12||||0.769
71802359|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
71802360|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.7|0.85||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.85|0.70|
71802361|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.62|0.79||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.79|0.62|
71802362|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.76|||||TWO_SIDED|95.0|0.7|0.82||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.70|
71802363|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.8||||||95.0|0.73|0.88||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.88|0.73|
71802364|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.9|||||TWO_SIDED|95.0|0.81|1.0||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.00|0.81|
71802365|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.74||||||95.0|0.67|0.82||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.82|0.67|
71802366|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.94|0.77|
71802367|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.78|0.96||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.96|0.78|
71841046|NCT04800211|143191015|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-2.586|||<|0.0001|TWO_SIDED|95.0|-3.092|-2.081|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Whole Blood COHb (% Saturation) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||-2.081|-3.092|<.0001
71841047|NCT04800211|143191017|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.42||||0.0839|TWO_SIDED|95.0|-0.19|3.04|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.04|-0.19|0.0839
71893996|NCT04899271|143310099|SUPERIORITY|||||||0.776|||||||Chi-squared|||Comparison at month 18||||0.776
71893997|NCT04899271|143310100|SUPERIORITY|||||||0.521||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.521
71802368|NCT04382326|143104254|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC was to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.64|||||TWO_SIDED|95.0|0.57|0.72||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.57|
71802369|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.87|||||TWO_SIDED|95.0|1.71|2.06||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.06|1.71|
71802370|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.94||||||95.0|2.64|3.26||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||3.26|2.64|
71802371|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.67|||||TWO_SIDED|95.0|1.51|1.84||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.84|1.51|
71802372|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.88||||||95.0|0.79|0.97||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.97|0.79|
71802373|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.95||||||95.0|5.39|6.55||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||6.55|5.39|
71802374|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.01||||||95.0|4.54|5.52||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.52|4.54|
71814082|NCT02798211|143130223|SUPERIORITY||Odds Ratio (OR)|4.77||||0.0149|TWO_SIDED|95.0|1.36|16.77|||Regression, Logistic|Statistical analysis (logistic regression) of ACR50 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.77|1.36|0.0149
71814083|NCT02798211|143130224|SUPERIORITY||Odds Ratio, log|10.5||||0.0243|TWO_SIDED|95.0|1.36|81.3|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response in treatment period 1 (non-responder imputation)||secukinumab 300mg s.c. injection, week 16||81.30|1.36|0.0243
71814084|NCT02798211|143130224|SUPERIORITY||Odds Ratio (OR)|5.42||||0.112|TWO_SIDED|95.0|0.67|43.64|||Regression, Logistic|Statistical analysis (logistic regression) of ACR70 response by visit in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||43.64|0.67|0.1120
71814085|NCT02798211|143130225|SUPERIORITY||Odds Ratio, log|9.49|||<|0.0001|TWO_SIDED|95.0|3.73|24.16|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||24.16|3.73|<0.0001
71814086|NCT02798211|143130225|SUPERIORITY||Odds Ratio (OR)|6.38||||0.0001|TWO_SIDED|95.0|2.51|16.24|||Regression, Logistic|Statistical analysis (logistic regression) of PASI75 response by visit - in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.24|2.51|0.0001
71814087|NCT02798211|143130226|SUPERIORITY||Odds Ratio, log|9.86|||<|0.0001|TWO_SIDED|95.0|3.19|30.45|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||30.45|3.19|<.0001
71814088|NCT02798211|143130226|SUPERIORITY||Odds Ratio (OR)|5.21||||0.0043|TWO_SIDED|95.0|1.68|16.21|||Regression, Logistic|Statistical analysis (logistic regression) of PASI90 response in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||16.21|1.68|0.0043
71814089|NCT02798211|143130227|SUPERIORITY||Odds Ratio, log|14.38||||0.0107|TWO_SIDED|95.0|1.86|111.53|||Regression, Logistic|Statistical analysis (logistic regression) of PASI100 response by visit in treatment period 1 (non-responder imputation)||secukinumab 300 mg s.c. injection, week 16||111.53|1.86|0.0107
71814090|NCT02798211|143130227|SUPERIORITY||Odds Ratio (OR)|9.82||||0.0307|TWO_SIDED|95.0|1.24|77.9|||Regression, Logistic|Statistical analysis (logistic regression) of PAS100 response by in treatment period 1 (non-responder imputation)||secukinumab 150 mg s.c. injection, week 16||77.90|1.24|0.0307
71814091|NCT02798211|143130228|SUPERIORITY||LS Mean of Treatment Difference|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.45|-0.65|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection, 16 weeks|"Standard Error of Treatment Difference~0.203"|-0.65|-1.45|<.0001
71841048|NCT04800211|143191017|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|2.1||||0.0089|TWO_SIDED|95.0|0.53|3.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1 (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.66|0.53|0.0089
71841049|NCT04800211|143191018|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.26||||0.7101|TWO_SIDED|95.0|-1.13|1.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.66|-1.13|0.7101
71841050|NCT04800211|143191018|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.24||||0.7325|TWO_SIDED|95.0|-1.12|1.59|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||1.59|-1.12|0.7325
71841051|NCT04800211|143191019|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.48||||0.0136|TWO_SIDED|95.0|0.31|2.66|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.66|0.31|0.0136
71841052|NCT04800211|143191019|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.94||||0.0009|TWO_SIDED|95.0|0.8|3.08|||ANCOVA||The ANCOVA includes study group, gender, and age class as fixed effects, and baseline score as the covariate. Least-squares means (LS Means) are calculated from the ANCOVA.|Null hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Screening) for Percentage of Predicted FEV1/FVC (%) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||3.08|0.80|0.0009
71841053|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.038||||0.9294|TWO_SIDED|95.0|-0.795|0.87|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.870|-0.795|0.9294
71841054|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.277||||0.529|TWO_SIDED|95.0|-0.587|1.142|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.142|-0.587|0.5290
71893998|NCT04899271|143310100|SUPERIORITY|||||||0.959||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.959
71893999|NCT04899271|143310100|SUPERIORITY|||||||0.773||||||Assumption of normality was confirmed by Kolmogorov-Smirnov test; the comparison between treatment arms was performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 18 for change from baseline||||0.773
71894000|NCT04899271|143310101|SUPERIORITY|||||||0.691|||||||t-test, 2 sided|Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.||Comparison at month 6 for change from baseline||||0.691
71802375|NCT04382326|143104254|NON_INFERIORITY|For the additional 7 serotypes, the compared results were from serotype 1 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.4|||||TWO_SIDED|95.0|3.99|4.85||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.85|3.99|
71802376|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-4.3|||||TWO_SIDED|95.0|-7.5|-1.4||||||Diphtheria: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||-1.4|-7.5|
71802377|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.3|||||TWO_SIDED|95.0|-1.0|1.7||||||Tetanus: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.7|-1.0|
71802378|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-0.2||||||95.0|-3.5|3.1||||||Pertussis (PT): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.5|
71802379|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.6||||||95.0|-2.5|3.9||||||Pertussis (FHA): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.9|-2.5|
71802380|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|-1.3||||||95.0|-4.7|2.2||||||Pertussis (PRN): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.2-Sided CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.2|-4.7|
71802381|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|2.9||||||HBsAg: 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||2.9|-3.2|
71802382|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.4|3.2||||||Poliovirus (Type 1): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.2|-3.4|
71802383|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.8||||||95.0|-2.4|4.6||||||Poliovirus (Type 2): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||4.6|-2.4|
71802384|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0||||||95.0|-3.2|3.1||||||Poliovirus (Type 3): 2-Sided CI was calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.1|-3.2|
71802385|NCT04382326|143104255|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the percentage differences (20vPnC - 13vPnC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0||||||Hib (≥0.15 μg/mL): 2-Sided CI were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||3.0|-3.0|
71802386|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.65|||||TWO_SIDED|95.0|0.59|0.72||||||Serotype 1: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.72|0.59|
71802387|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7|||||TWO_SIDED|95.0|0.64|0.76||||||Serotype 3: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.76|0.64|
71802388|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.7||||||95.0|0.63|0.78||||||Serotype 4: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.78|0.63|
71802389|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.69||||||95.0|0.61|0.77||||||Serotype 5: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.77|0.61|
71894001|NCT04899271|143310101|SUPERIORITY|||||||0.685||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.685
71894002|NCT04899271|143310101|SUPERIORITY|||||||0.64||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.640
71802390|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72||||||95.0|0.65|0.81||||||Serotype 6A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.65|
71894003|NCT04899271|143310102|SUPERIORITY|||||||0.867||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||Comparison at month 6||||0.867
71894004|NCT04899271|143310102|SUPERIORITY|||||||0.769||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared and Fisher's Exact test separated with a /.||Comparison at month 12||||0.769
71894005|NCT04899271|143310102|SUPERIORITY|||||||0.577|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||Comparison at month 18||||0.577
71894006|NCT04899271|143310103|SUPERIORITY|The effect of treatment on the cumulative number of severe hypoglycemic events was evaluated by means of a Cox proportional hazards model. The Andersen-Gill intensity model with model-based variance was utilized.|Hazard Ratio (HR)|1.271||||0.554|TWO_SIDED|95.0|0.573|2.819|||Cox proportional hazards model|Analysis is based on Cox proportional hazards model.||||2.819|0.573|0.554
71802391|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 6B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.70|0.51|
71894007|NCT04899271|143310105|SUPERIORITY|||||||0.32||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 6 for change from baseline||||0.320
71894008|NCT04899271|143310105|SUPERIORITY|||||||0.398||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 12 for change from baseline||||0.398
71894009|NCT04899271|143310105|SUPERIORITY|||||||1||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||1.000
71894010|NCT04899271|143310106|SUPERIORITY|||||||0.892||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 6 for change from baseline||||0.892
71894011|NCT04899271|143310106|SUPERIORITY|||||||0.412||||||Assumption of normality is confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample t-test.|t-test, 2 sided|||Comparison at month 12 for change from baseline||||0.412
71894012|NCT04899271|143310106|SUPERIORITY|||||||0.371||||||Assumption of normality is not confirmed by Kolmogorov-Smirnov test; comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||Comparison at month 18 for change from baseline||||0.371
71894013|NCT01929083|143310111|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.04
71894014|NCT01929083|143310112|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.003
71894015|NCT01929083|143310113|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||P value for incidence of fatigue/malaise|Fisher Exact|||||||0.04
71894016|NCT01929083|143310113|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||p values for incidence of headache|Fisher Exact|||||||0.60
71802392|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.75||||||95.0|0.69|0.81||||||Serotype 7F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.81|0.69|
71894017|NCT01929083|143310113|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of mood changes|Fisher Exact|||||||0.23
71894018|NCT01929083|143310113|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||p value for incidence of breast tenderness|Fisher Exact|||||||0.23
71802393|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.65|0.8||||||Serotype 9V: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.80|0.65|
71802394|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.71|0.89||||||Serotype 14: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.89|0.71|
71814092|NCT02798211|143130228|SUPERIORITY||LS Means of Treatment Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.24|-0.43|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in DAS28-CRP score in treatment period 1 (LOCF)||secukinumab 150 mg s.c. injection|"LS Mean of Treatment Difference~0.207"|-0.43|-1.24|<.0001
71894019|NCT01929083|143310113|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of hypotension|Fisher Exact|||||||0.48
71894020|NCT01929083|143310113|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||p value for incidence of vertigo requiring discontinuation of therapy|Fisher Exact|||||||0.48
71894021|NCT01929083|143310114|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
71894022|NCT01929083|143310115|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.002
71841055|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.508||||0.2291|TWO_SIDED|95.0|-1.337|0.321|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.321|-1.337|0.2291
71802395|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.77||||||95.0|0.7|0.84||||||Serotype 18C: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.84|0.70|
71802396|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.86||||||Serotype 19A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.72|
71841056|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.525||||0.2179|TWO_SIDED|95.0|-0.311|1.361|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.361|-0.311|0.2179
71894023|NCT01929083|143310116|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|||||p value for bradycardia|Fisher Exact|||||||0.65
71894024|NCT01929083|143310116|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for burning at infusion site|Fisher Exact|||||||>0.99
71802397|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.79||||||95.0|0.73|0.86||||||Serotype 19F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.86|0.73|
71802398|NCT04382326|143104256|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group. Noninferiority was declared for if the lower bound of the 2-sided 95% CI for the IgG GMR of 20vPnC to 13vPnC for the serotype is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.75||||||Serotype 23F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC-13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.75|0.58|
71802399|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.98||||||95.0|1.81|2.16||||||Serotype 8: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||2.16|1.81|
71802400|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.32||||||95.0|1.18|1.49||||||Serotype 10A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.49|1.18|
71802401|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.52||||||95.0|1.39|1.67||||||Serotype 11A: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.67|1.39|
71802402|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6||||||95.0|0.54|0.67||||||Serotype 12F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||0.67|0.54|
71894025|NCT01929083|143310116|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED|||||p value for transient QTc interval \> 500 ms|Fisher Exact|||||||> 0.99
71894026|NCT01929083|143310117|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.43
71894027|NCT01929083|143310118|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.36
71894028|NCT01929083|143310119|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.0001
71894029|NCT01929083|143310120|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.0001
71894030|NCT02586805|143310132|OTHER||% change in mean rate (vs placebo)|-75.609|||<|0.001|TWO_SIDED|95.0|-84.65|-61.243||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.243|-84.650|<0.001
71802403|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.82|||||TWO_SIDED|95.0|4.39|5.3||||||Serotype 15B: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||5.30|4.39|
71802404|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|4.06||||||95.0|3.68|4.48||||||Serotype 22F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||4.48|3.68|
71814093|NCT02798211|143130229|SUPERIORITY||LS Mean of Treatment Difference|-0.21||||0.0107|TWO_SIDED|95.0|-0.37|-0.05|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by in treatment period 1 (LOCF)||secukinumab 300mg s.c. injection|"Standard Error of Treatment Difference~0.081"|-0.05|-0.37|0.0107
71814094|NCT02798211|143130229|SUPERIORITY|secukinumab 150 mg s.c. injection|LS Mean Treatment Difference|-0.13||||0.1109|TWO_SIDED|95.0|-0.3|0.03|||ANCOVA|Statistical analysis (ANCOVA) of change from baseline in HAQ-DI score by visit - in treatment period 1 (LOCF)|||"Standard Error of Treatment Difference~-0.083"|0.03|-0.30|0.1109
71814095|NCT01982435|143130236|OTHER|Measures were summarized using means, range and standard error of the means (SEM).|||||<|0.05||||||Two-sided paired t-tests and two-sided unpaired t-tests were respectively conducted to analyze efficacy endpoints between study initiation to end, and between monthly and TAE injection regimens.|t-test, 2 sided|||All analyses were performed with a significance level of 0.05 being assumed for all tests.||||<0.05
71814096|NCT01892345|143130264|OTHER|Treatment Effect|Hazard Ratio (HR)|0.058|||<|0.0001|TWO_SIDED|95.0|0.017|0.197|||Stratified Log-Rank Test||HR based on a stratified Cox proportional hazards model. Confidence interval = Wald confidence interval. HR for eculizumab compared with placebo represented a 94.2% reduction in the risk of relapse, 95% Wald confidence interval (80.3%, 98.3%).|||0.197|0.017|<0.0001
71814097|NCT01473381|143130314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.0073|TWO_SIDED|95.0|-4.3|-0.84||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.84|-4.30|0.0073
71814098|NCT01473381|143130314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.82||||0.0034|TWO_SIDED|95.0|-4.57|-1.06||P-value was adjusted for multiplicity.|Mixed-effect model|||||-1.06|-4.57|0.0034
71814099|NCT01473381|143130314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.002|TWO_SIDED|95.0|-4.48|-1.0||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-1.00|-4.48|0.0020
71814100|NCT01473381|143130315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.58|-0.13||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.13|-0.58|0.0073
71814101|NCT01473381|143130315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0097|TWO_SIDED|95.0|-0.55|-0.1||P-value was adjusted for multiplicity.|Mixed-effect model|||||-0.10|-0.55|0.0097
71814102|NCT01473381|143130315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0025|TWO_SIDED|95.0|-0.57|-0.12||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model|||||-0.12|-0.57|0.0025
71814103|NCT01473381|143130316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.3563|TWO_SIDED|95.0|-3.9|10.9||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||10.9|-3.9|0.3563
71814104|NCT01473381|143130316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.1611|TWO_SIDED|95.0|-0.4|14.6||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||14.6|-0.4|0.1611
71814105|NCT01473381|143130316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.2672|TWO_SIDED|95.0|-2.7|12.2||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.||||12.2|-2.7|0.2672
71814106|NCT04026165|143130347|SUPERIORITY||Difference in Adjusted Mean|1.2|STANDARD_ERROR_OF_MEAN|0.82||0.1439|TWO_SIDED|95.0|-0.41|2.81|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcr from treatment-specific Baselines at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for treatment-specific Baseline eGFRcr, pre-run-in urine albumin to creatinine ratio (UACR) category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of sodium-glucose co-transporter-2 (SGLT-2) inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||2.81|-0.41|0.1439
71814107|NCT04026165|143130348|SUPERIORITY||Difference in Percentage|0.1||||0.8353|TWO_SIDED|95.0|-10.9|11.4||p-value was based on Cochran-Mantel-Haenszel test stratified by Randomization stratification factors. Randomization stratification factors= pre-run-in eGFRcr stratum, pre-run-in UACR category and concomitant use of SGLT-2 inhibitors at Randomization.|Cochran-Mantel-Haenszel||95% exact CI based on the Santner-Snell method was presented for the difference in proportions between SEL and placebo arms.|||11.4|-10.9|0.8353
71894031|NCT02586805|143310132|OTHER||% change in mean rate (vs placebo)|-73.271|||<|0.001|TWO_SIDED|95.0|-82.379|-59.456||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-59.456|-82.379|<0.001
71894032|NCT02586805|143310132|OTHER||% change in mean rate (vs placebo)|-86.921|||<|0.001|TWO_SIDED|95.0|-92.828|-76.15||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-76.150|-92.828|<0.001
71894033|NCT02586805|143310133|OTHER||% change in mean rate (vs placebo)|-80.842|||<|0.001|TWO_SIDED|95.0|-89.169|-66.114||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-66.114|-89.169|<0.001
71894034|NCT02586805|143310133|OTHER||% change in mean rate (vs placebo)|-74.169|||<|0.001|TWO_SIDED|95.0|-83.733|-58.983||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-58.983|-83.733|<0.001
71894035|NCT02586805|143310133|OTHER||% change in mean rate (vs placebo)|-87.299|||<|0.001|TWO_SIDED|95.0|-93.494|-75.204||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-75.204|-93.494|<0.001
71894036|NCT02586805|143310134|OTHER||% change in mean rate (vs placebo)|-70.497|||<|0.001|TWO_SIDED|95.0|-82.696|-49.699||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-49.699|-82.696|<0.001
71894037|NCT02586805|143310134|OTHER||% change in mean rate (vs placebo)|-73.285|||<|0.001|TWO_SIDED|95.0|-84.316|-54.496||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-54.496|-84.316|<0.001
71894038|NCT02586805|143310134|OTHER||% change in mean rate (vs placebo)|-83.394|||<|0.001|TWO_SIDED|95.0|-91.618|-67.099||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-67.099|-91.618|<0.001
71894039|NCT02586805|143310135|OTHER||% change in mean rate (vs placebo)|-77.622|||<|0.001|TWO_SIDED|95.0|-86.253|-63.572||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-63.572|-86.253|<0.001
71894040|NCT02586805|143310135|OTHER||% change in mean rate (vs placebo)|-75.377|||<|0.001|TWO_SIDED|95.0|-84.115|-61.833||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-61.833|-84.115|<0.001
71814108|NCT04026165|143130349|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.201|TWO_SIDED|95.0|0.81|2.72|||Stratified Log-Rank|P-value was calculated using a stratified log-rank test, stratified by randomization stratification factors.|Hazard ratio and 95% CI were estimated using a stratified Cox proportional hazard model, stratified by randomization stratification factors and were reported only for outcomes with more than 10 events, and have at least 1 event in each treatment arm.|||2.72|0.81|0.2010
71841057|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.401||||0.2002|TWO_SIDED|95.0|-0.213|1.016|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||1.016|-0.213|0.2002
71841058|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.29||||0.476|TWO_SIDED|95.0|-1.089|0.509|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 6). (mITT Population)||0.509|-1.089|0.4760
71841059|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.699||||0.0914|TWO_SIDED|95.0|-1.512|0.113|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 7 (Week 12). (mITT Population)||0.113|-1.512|0.0914
71841060|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|0.328||||0.9705|TWO_SIDED|95.0|-1.122|1.777|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.777|-1.122|0.9705
71802405|NCT04382326|143104256|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 19A (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.64||||||95.0|1.46|1.83||||||Serotype 33F: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - lowest 13vPnC) of the logarithms of the IgG concentrations and the corresponding CI (based on the Student's t distribution).||1.83|1.46|
71802406|NCT04382326|143104264|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.29||||||95.0|1.05|1.58||||||Measles: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.58|1.05|
71802407|NCT04382326|143104265|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.08|||||TWO_SIDED|95.0|0.85|1.38||||||Mumps: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.38|0.85|
71802408|NCT04382326|143104266|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|1.23|||||TWO_SIDED|95.0|1.02|1.48||||||Rubella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution).||1.48|1.02|
71802409|NCT04382326|143104267|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR of 20vPnC group to 13vPnC group is greater than 0.5 (2-fold NI margin).|Geometric Mean Ratios|0.99|||||TWO_SIDED|95.0|0.84|1.17||||||Varicella: GMR and 2-Sided CI were calculated by exponentiating the mean difference (20vPnC - 13vPnC) of the logarithms of the concentrations and the corresponding CI (based on the Student's t distribution)||1.17|0.84|
71802410|NCT03017508|143104268|SUPERIORITY||Mean Difference (Final Values)|-8.34|STANDARD_DEVIATION|18.34||0.056|TWO_SIDED||||||t-test, 2 sided|||Paired t-test on VAS scores during speech comparing sublingual riluzole to placebo||||0.056
71894041|NCT02586805|143310135|OTHER||% change in mean rate (vs placebo)|-89.008|||<|0.001|TWO_SIDED|95.0|-94.325|-78.707||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% \* (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.|-78.707|-94.325|<0.001
71894042|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 1||||< 0.0001
71894043|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 2||||< 0.0001
71894044|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 3||||< 0.0001
71894045|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 4||||< 0.0001
71894046|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 5||||< 0.0001
71894047|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 6||||< 0.0001
71894048|NCT00500071|143310137|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Week 7||||< 0.0001
71894049|NCT00500071|143310138|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
71894050|NCT00500071|143310141|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||||||< 0.0001
71894051|NCT00500071|143310142|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Global Executive Composite||||< 0.0001
71894052|NCT00500071|143310142|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Behavioral Recognition Index||||< 0.0001
71894053|NCT00500071|143310142|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 1 sided|||Metacognition Index||||< 0.0001
71894054|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 2 between the two arms."|Difference in Change|-0.32||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two arms"||||0.02
71894055|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean problems maintaining an erection score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in problems maintaining an erection score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two arms"||||0.11
71894056|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two arms"||||0.02
71896324|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|21.736||||0.038|TWO_SIDED|95.0|1.183|399.541||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||399.541|1.183|0.038
71802411|NCT02114892|143104319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
71802412|NCT02114892|143104320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
71802413|NCT02114892|143104321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.070
71802414|NCT02114892|143104322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338|||||||Wilcoxon (Mann-Whitney)|||||||0.338
71802415|NCT02114892|143104323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.278|||||||Wilcoxon (Mann-Whitney)|||||||0.278
71802416|NCT02114892|143104324|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71802417|NCT02114892|143104325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|||||||Wilcoxon (Mann-Whitney)|||||||0.083
71802418|NCT02114892|143104326|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71802419|NCT02114892|143104327|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71802420|NCT02114892|143104328|SUPERIORITY_OR_OTHER_LEGACY|||||||0.946|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.946
71802421|NCT02114892|143104329|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.365
71802422|NCT02114892|143104330|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.557
71802423|NCT02114892|143104331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71802424|NCT02114892|143104332|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71802425|NCT02114892|143104333|SUPERIORITY_OR_OTHER_LEGACY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|||||||0.672
71814109|NCT04026165|143130351|SUPERIORITY||Difference in Adjusted Mean|0.44|STANDARD_ERROR_OF_MEAN|0.72||0.5399|TWO_SIDED|95.0|-0.97|1.86|||Random Slope Model|||Estimates were from a random slope model with change in eGFRcys from pre-run-in Baseline at Weeks 4, 8, 12, 24, 36, 48, 60, 72, and 84 as outcome, including terms for pre-run-in Baseline eGFRcys, pre-run-in UACR category (\< 1500 mg/g vs. \>= 1500 mg/g), concomitant use of SGLT-2 inhibitors at Randomization, treatment group, week, and treatment-by-week interaction, where week has a random effect.||1.86|-0.97|0.5399
71894057|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two arms"||||0.01
71894058|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 2 between the two arms."|Difference in Change|-0.28||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two arms"||||0.01
71894059|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 2 between the two arms."|Difference in Change|-0.24||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two arms"||||0.02
71894060|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 2 between the two arms."|Difference in Change|-0.19||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two arms"||||0.11
71894061|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 2 between the two arms."|Difference in Change|-0.16||||0.21|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two arms"||||0.21
71894062|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 2 between the two arms."|Difference in Change|-0.14||||0.33|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two arms"||||0.33
71802426|NCT03586999|143104337|SUPERIORITY||proportion|0.3||||0.1|TWO_SIDED|90.0||||The proportion achieving a complete response will be calculated and will compared to null proportion of 30%. The population proportion for complete response rate, p-value and 90% confidence intervals for the complete response rate will be calculated.|t-test, 2 sided|||The study was to be suspended, if, at any time, there was sufficient evidence to suggest that the true probability of achieving a complete response falls below 30% while assuming the treatment drug will elicit a 56% complete response rate. Statistically significant evidence for this low complete response rate is defined as an observed complete response rate whose upper one-sided 90% confidence limit is 0-30%. Sample size calculations were made assuming 80% power.||||.1
71802427|NCT04096560|143104347|SUPERIORITY||LS Mean Difference|26.4|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|20.07|32.73||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||32.73|20.07|<0.001
71802428|NCT04096560|143104347|SUPERIORITY||LS Mean Difference|29.9|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|23.68|36.07||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||36.07|23.68|<0.001
71802429|NCT04096560|143104347|SUPERIORITY||LS Mean Difference|35.0|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|28.73|41.34||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||41.34|28.73|<0.001
71802430|NCT04096560|143104354|SUPERIORITY||LS Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-14.07|-6.16||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-6.16|-14.07|<0.001
71802431|NCT04096560|143104354|SUPERIORITY||LS Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED|95.0|-15.2|-7.56||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-7.56|-15.20|<0.001
71894063|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two arms"||||0.46
71894064|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two arms"||||0.46
71894065|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 2 between the two arms."|Difference in Change|-0.07||||0.58|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two arms"||||0.58
71894066|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 2 between the two arms."|Difference in Change|0.01||||0.92|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two arms"||||0.92
71894067|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 2 between the two arms."|Difference in Change|0.02||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two arms"||||0.84
71894068|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 2 between the two arms."|Difference in Change|0.03||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two arms"||||0.83
71894069|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 2 between the two arms."|Difference in Change|0.04||||0.72|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two arms"||||0.72
71841061|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|0.977||||0.328|TWO_SIDED|95.0|-0.512|2.465|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.465|-0.512|0.3280
71802432|NCT04096560|143104354|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.95|<|0.001|TWO_SIDED|95.0|-16.96|-9.09||The analysis used a linear MMRM with fixed effects for baseline (Day -1 mean values), treatment, visit, and treatment-by-visit interaction. Visit was repeated factor in the model.|MMRM|The unstructured covariance structure was used for the repeated statement.||||-9.09|-16.96|<0.001
71802433|NCT04096560|143104355|SUPERIORITY||IRR|0.05|||=|0.002|TWO_SIDED|95.0|0.007|0.317||The incidence rate was the exponentiated LS means and the incidence rate ratio (IRR) was the exponentiated LS mean differences from the generalized estimating equation (GEE) Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.317|0.007|=0.002
71802434|NCT04096560|143104355|SUPERIORITY||IRR|0.2|||=|0.019|TWO_SIDED|95.0|0.05|0.767||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.767|0.050|=0.019
71802435|NCT04096560|143104355|SUPERIORITY||IRR|0.15|||=|0.001|TWO_SIDED|95.0|0.047|0.482||The incidence rate was the exponentiated LS means and the IRR was the exponentiated LS mean differences from the GEE Poisson regression model.|MMRM|The Poisson regression with natural log link was on the count of cataplexy per week.||||0.482|0.047|=0.001
71894070|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 2 between the two arms."|Difference in Change|0.06||||0.48|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two arms"||||0.48
71894071|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 2 between the two arms."|Difference in Change|0.08||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two arms"||||0.54
71894072|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 2 between the two arms."|Difference in Change|0.09||||0.56|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two arms"||||0.56
71894073|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 2 between the two arms."|Difference in Change|0.1||||0.22|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two arms"||||0.22
71802436|NCT00534352|143104372|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|95.47||||||90.0|82.77|110.1||No p-values.|Mixed Models Analysis (Cmin)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmin. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.1|82.77|
71802437|NCT00534352|143104372|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|102.6||||||90.0|92.91|113.3||No p-values.|Mixed Models Analysis (Cmax)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||113.3|92.91|
71802438|NCT00534352|143104372|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|LS means of ratios|98.97||||||90.0|89.23|109.8||No p-values.|Mixed Models Analysis (AUC24)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||109.8|89.23|
71802439|NCT00534352|143104372|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|99.3||||||90.0|89.39|110.3||No p-values.|Mixed Models Analysis (Css,av)|The linear mixed effects model was controlled for treatment as fixed effects, and subject as a random effect.|The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.||110.3|89.39|
71802440|NCT01591746|143104384|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71802441|NCT01591746|143104385|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
71802442|NCT01591746|143104386|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Right breast initial percent volume expansion||||0.45
71802443|NCT01591746|143104386|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Left breast initial percent volume expansion||||0.98
71802444|NCT01591746|143104387|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71802445|NCT01591746|143104388|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71802446|NCT01591746|143104389|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71802447|NCT00833924|143104424|SUPERIORITY_OR_OTHER||Rate of 30-day freedom from MAE|99.2|||<|0.01|TWO_SIDED|95.0|95.4|100.0|||Exact binomial test|||Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).||100|95.4|<0.01
71802448|NCT00833924|143104425|SUPERIORITY_OR_OTHER||12-month Device Success Rate|97.3|||<|0.01|TWO_SIDED|95.0|92.4|99.4|||Exact binomial test|||Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).||99.4|92.4|<0.01
71802449|NCT01485861|143104429|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.77||||0.1606|TWO_SIDED|90.0|0.56|1.04|||Log Rank|||||1.04|0.56|0.1606
71802450|NCT01485861|143104429|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.89||||0.53|TWO_SIDED|90.0|0.66|1.2|||Log Rank|||||1.20|0.66|0.5300
71802451|NCT01485861|143104429|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen \[PSA\] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.75||||0.1689|TWO_SIDED|90.0|0.54|1.05|||Log Rank|||||1.05|0.54|0.1689
71802452|NCT01485861|143104429|SUPERIORITY|Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).|Hazard Ratio (HR)|0.94||||0.7484|TWO_SIDED|90.0|0.69|1.28|||Log Rank|||||1.28|0.69|0.7484
71802453|NCT01485861|143104430|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.39||||0.0064|TWO_SIDED|90.0|0.22|0.7|||Log Rank|||||0.70|0.22|0.0064
71802454|NCT01485861|143104430|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.46||||0.0285|TWO_SIDED|90.0|0.25|0.83|||Log Rank|||||0.83|0.25|0.0285
71802455|NCT01485861|143104448|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.87||||0.417|TWO_SIDED|95.0|0.62|1.22|||Log Rank|||||1.22|0.62|0.4170
71802456|NCT01485861|143104448|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.93||||0.6712|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.6712
71802457|NCT01485861|143104448|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5164|TWO_SIDED|95.0|0.62|1.27|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.27|0.62|0.5164
71802458|NCT01485861|143104448|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.8955|TWO_SIDED|95.0|0.72|1.44|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.44|0.72|0.8955
71802459|NCT01485861|143104449|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.63||||0.1472|TWO_SIDED|95.0|0.33|1.19|||Log Rank|||||1.19|0.33|0.1472
71802460|NCT01485861|143104449|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.45||||0.0157|TWO_SIDED|95.0|0.23|0.87|||Log Rank|||||0.87|0.23|0.0157
71802461|NCT01485861|143104452|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.0665|TWO_SIDED|90.0|0.51|0.97|||Log Rank|||||0.97|0.51|= 0.0665
71802462|NCT01485861|143104452|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.9319|TWO_SIDED|90.0|0.73|1.33|||Log Rank|||||1.33|0.73|= 0.9319
71802463|NCT01485861|143104452|SUPERIORITY||Hazard Ratio (HR)|0.7|||=|0.071|TWO_SIDED|90.0|0.5|0.97|||Log Rank|||Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||0.97|0.50|= 0.0710
71802464|NCT01485861|143104452|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.789|TWO_SIDED|90.0|0.7|1.31|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.31|0.70|= 0.7890
71802465|NCT01485861|143104453|SUPERIORITY||Hazard Ratio (HR)|0.68|||=|0.2906|TWO_SIDED|90.0|0.37|1.25|||Log Rank|||||1.25|0.37|= 0.2906
71802466|NCT01485861|143104453|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.2716|TWO_SIDED|90.0|0.35|1.22|||Log Rank|||||1.22|0.35|= 0.2716
71802467|NCT01485861|143104454|SUPERIORITY|Unstratified|Difference in response rates|1.97|||=|0.7913|TWO_SIDED|90.0|-10.25|14.18|||Chi-squared|||||14.18|-10.25|= 0.7913
71802468|NCT01485861|143104454|SUPERIORITY|Unstratified|Difference in response rates|-1.22|||=|0.8675|TWO_SIDED|90.0|-13.24|10.8|||Chi-squared|||||10.80|-13.24|= 0.8675
71802469|NCT01485861|143104455|SUPERIORITY||Difference in response rates|11.43|||=|0.4176|TWO_SIDED|90.0|-11.43|58.32|||Chi-squared|||||58.32|-11.43|= 0.4176
71802470|NCT01485861|143104455|SUPERIORITY||Difference in response rates|15.43|||=|0.2802|TWO_SIDED|90.0|-7.58|38.44|||Chi-squared|||||38.44|-7.58|= 0.2802
71802471|NCT01485861|143104456|SUPERIORITY||Difference in response rates|9.58|||=|0.3646|TWO_SIDED|90.0|-7.65|26.8|||Chi-squared|||||26.80|-7.65|= 0.3646
71802472|NCT01485861|143104456|SUPERIORITY||Difference in response rates|0.22|||=|0.9821|TWO_SIDED|90.0|-15.89|16.33|||Chi-squared|||||16.33|-15.89|= 0.9821
71802473|NCT01485861|143104457|SUPERIORITY||Difference in response rates|-3.17|||=|0.8489|TWO_SIDED|90.0|-30.93|24.58|||Chi-squared|||||24.58|-30.93|= 0.8489
71802474|NCT01485861|143104457|SUPERIORITY||Difference in response rates|12.38|||=|0.5186|TWO_SIDED|90.0|-16.36|41.12|||Chi-squared|||||41.12|-16.36|= 0.5186
71802475|NCT01485861|143104458|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.31|||=|0.678|TWO_SIDED|90.0|0.45|3.8|||Log Rank|||||3.80|0.45|= 0.6780
71802476|NCT01485861|143104458|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.85|||=|0.8372|TWO_SIDED|90.0|0.24|3.02|||Log Rank|||||3.02|0.24|= 0.8372
71802477|NCT01485861|143104458|SUPERIORITY||Hazard Ratio (HR)|0.77|||=|0.7733|TWO_SIDED|90.0|0.17|3.5|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||3.50|0.17|= 0.7733
71802478|NCT01485861|143104458|SUPERIORITY||Hazard Ratio (HR)|2.46|||=|0.4227|TWO_SIDED|90.0|0.36|16.59|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||16.59|0.36|= 0.4227
71802479|NCT01485861|143104459|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.3173|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.3173
71802480|NCT01485861|143104459|SUPERIORITY||Hazard Ratio (HR)|999.99|||=|0.6171|TWO_SIDED|90.0|0.0||NA = Not estimable due to limited number of events observed||Log Rank||\>||||0.00|= 0.6171
71802481|NCT01485861|143104460|SUPERIORITY||Difference in response rates|3.75|||=|0.6652|TWO_SIDED|90.0|-10.47|17.97|||Chi-squared|||||17.97|-10.47|= 0.6652
71802482|NCT01485861|143104460|SUPERIORITY||Difference in response rates|7.48|||=|0.3734|TWO_SIDED|90.0|-6.29|21.24|||Chi-squared|||||21.24|-6.29|= 0.3734
71802483|NCT01485861|143104461|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
71802484|NCT01485861|143104461|SUPERIORITY||Difference in response rates|4.41|||=|0.7633|TWO_SIDED|90.0|-19.76|28.58|||Chi-squared|||||28.58|-19.76|= 0.7633
71802485|NCT01485861|143104462|SUPERIORITY||Difference in response rates|2.24|||=|0.8317|TWO_SIDED|90.0|-15.07|19.54|||Chi-squared|||||19.54|-15.07|= 0.8317
71802486|NCT01485861|143104462|SUPERIORITY||Difference in response rates|5.14|||=|0.6139|TWO_SIDED|90.0|-11.6|21.88|||Chi-squared|||||21.88|-11.60|= 0.6139
71802487|NCT01485861|143104463|SUPERIORITY||Difference in response rates|34.85|||=|0.0505|TWO_SIDED|90.0|7.14|62.56|||Chi-squared|||||62.56|7.14|= 0.0505
71802488|NCT01485861|143104463|SUPERIORITY||Difference in response rates|-9.6|||=|0.4989|TWO_SIDED|90.0|-32.54|13.35|||Chi-squared|||||13.35|-32.54|= 0.4989
71894074|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 2 between the two arms."|Difference in Change|0.11||||0.4|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two arms"||||0.40
71894075|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 2 between the two arms."|Difference in Change|0.13||||0.35|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two arms"||||0.35
71894076|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 2 between the two arms."|Difference in Change|0.17||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two arms"||||0.11
71894077|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.11|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two arms"||||0.11
71894078|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.15|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two arms"||||0.15
71894079|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 2 between the two arms."|Difference in Change|0.22||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two arms"||||0.08
71802489|NCT01485861|143104466|SUPERIORITY|Unstratified|Hazard Ratio (HR)|0.95|||=|0.8483|TWO_SIDED|90.0|0.61|1.47|||Log Rank|||||1.47|0.61|= 0.8483
71802490|NCT01485861|143104466|SUPERIORITY|Unstratified|Hazard Ratio (HR)|1.08|||=|0.785|TWO_SIDED|90.0|0.7|1.65|||Log Rank|||||1.65|0.70|= 0.7850
71802491|NCT01485861|143104466|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.8847|TWO_SIDED|90.0|0.66|1.65|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.65|0.66|= 0.8847
71802492|NCT01485861|143104466|SUPERIORITY||Hazard Ratio (HR)|1.05|||=|0.8647|TWO_SIDED|90.0|0.67|1.63|||Log Rank|||Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).||1.63|0.67|= 0.8647
71802493|NCT01485861|143104467|SUPERIORITY||Hazard Ratio (HR)|0.89|||=|0.8271|TWO_SIDED|90.0|0.39|2.06|||Log Rank|||||2.06|0.39|= 0.8271
71802494|NCT01485861|143104467|SUPERIORITY||Hazard Ratio (HR)|0.84|||=|0.7383|TWO_SIDED|90.0|0.35|2.02|||Log Rank|||||2.02|0.35|= 0.7383
71802495|NCT01144338|143104475|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.91||||0.061|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||||1.004|0.832|0.061
71802496|NCT01144338|143104476|NON_INFERIORITY|Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR \< 1.3|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.0|0.832|1.004|||Regression, Cox|||This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.||1.004|0.832|< 0.001
71802497|NCT01144338|143104477|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.86||||0.016|TWO_SIDED|95.0|0.77|0.97|||Regression, Cox|||||0.97|0.77|0.016
71802498|NCT01144338|143104478|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.88||||0.096|TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|||||1.02|0.76|0.096
71802499|NCT01144338|143104479|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.97||||0.622|TWO_SIDED|95.0|0.85|1.1|||Regression, Cox|||||1.10|0.85|0.622
71802500|NCT01144338|143104480|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.85||||0.095|TWO_SIDED|95.0|0.7|1.03|||Regression, Cox|||||1.03|0.70|0.095
71802501|NCT01144338|143104481|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|1.05||||0.402|TWO_SIDED|95.0|0.94|1.18|||Regression, Cox|||||1.18|0.94|0.402
71802502|NCT01144338|143104482|SUPERIORITY|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR \< 1|Hazard Ratio (HR)|0.94||||0.485|TWO_SIDED|95.0|0.78|1.13|||Regression, Cox|||||1.13|0.78|0.485
71802503|NCT04122443|143104515|SUPERIORITY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.3|1.9||||||||1.9|0.3|
71802504|NCT04122443|143104516|SUPERIORITY||Mean Difference (Final Values)|13.0|||||TWO_SIDED|95.0|-3.0|29.0||||||||29|-3|
71802505|NCT04122443|143104517|SUPERIORITY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-5.0|23.0||||||||23|-5|
71802506|NCT04122443|143104518|SUPERIORITY||Mean Difference (Final Values)|6.0|||||TWO_SIDED|95.0|-10.0|21.0||||||||21|-10|
71802507|NCT01072201|143104520|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71802508|NCT01072201|143104521|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71802509|NCT01072201|143104522|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups||||0.05
71802510|NCT03149328|143104546|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.3||||||Threshold for statistical significance was p=0.05|ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis is that both groups are the same.||||0.30
71841062|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)|Mean Difference (Net)|-0.218||||0.9951|TWO_SIDED|95.0|-1.667|1.23|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 6). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 6). (mITT Population)||1.230|-1.667|0.9951
71841063|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.225||||0.1367|TWO_SIDED|95.0|-0.244|2.693|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.693|-0.244|0.1367
71841064|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|1.101||||0.0294|TWO_SIDED|95.0|0.111|2.091|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 7 (Week 12). (mITT Population)||2.091|0.111|0.0294
71841065|NCT04800211|143191020|EQUIVALENCE|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)|Mean Difference (Net)|-0.248||||0.6792|TWO_SIDED|95.0|-1.424|0.928|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Test 2 on Visit 7 (Week 12). Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Test 2 on Visit 7 (Week 12). (mITT Population)||0.928|-1.424|0.6792
71894080|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 2 between the two arms."|Difference in Change|0.34||||0.02|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two arms"||||0.02
71802511|NCT03149328|143104547|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates).||||||0.28|||||||ANCOVA|||We will examine the trajectories of outcome measures for patients in the comparator and intervention groups. The area under the curve (AUC) will be calculated for each trajectory during the period that the patient is participating to create a summary score. Null Hypothesis = both groups are the same||||0.28
71802512|NCT03149328|143104548|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.22||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of hospitalizations"||||0.22
71802513|NCT03149328|143104548|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.1||||||Threshold for statistical Significance was p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups in the number of emergency room visits"||||0.10
71802514|NCT03149328|143104549|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.18||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.18
71802515|NCT03149328|143104550|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)||||||0.79||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||0.79
71802516|NCT03149328|143104551|EQUIVALENCE|Based on a power analysis for an ANCOVA comparing 2 groups using the area under the curve approach, a total sample 459 (655 x 70% response rate) will provide 80% power to detect effect sizes (f2) of moderate magnitude at a statistical significance level of 0.05 (e.g., f2 ranging from 0.15 for 1 covariate to 0.19 for 10 covariates)|||||<|0.001||||||Threshold for statistical significance p = 0.05|ANCOVA|||"Analysis of covariance (ANCOVA) will be used as the method of analysis to compare outcomes of both groups while controlling for within- and between-group differences, such as comorbidities, gender, age and dialysis type. ANCOVA is necessary to control for baseline and potential confounders.~Null hypotheses = No difference between groups"||||<0.001
71802517|NCT01306617|143104575|SUPERIORITY_OR_OTHER|||||||0.547|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.||||0.547
71802518|NCT01306617|143104575|SUPERIORITY_OR_OTHER|||||||0.207|TWO_SIDED||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.207
71802519|NCT01306617|143104576|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
71802520|NCT01306617|143104577|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.061
71802521|NCT01306617|143104577|SUPERIORITY_OR_OTHER|||||||0.375|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.375
71802522|NCT01306617|143104578|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
71802523|NCT01306617|143104578|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
71802524|NCT01306617|143104579|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.312
71802525|NCT01306617|143104579|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (\<=800,000, \>800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||||||0.012
71802526|NCT01306617|143104580|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Log Rank|||||||0.395
71802527|NCT01306617|143104580|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Log Rank|||||||0.010
71802528|NCT01306617|143104581|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Log Rank|||||||0.048
71802529|NCT01130740|143104587|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Mixed Models Analysis|||This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)||||0.158
71802530|NCT01130740|143104587|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Mixed Models Analysis|||This is the 12-month comparison between the 2 study groups, which is the primary study analysis.||||0.008
71802531|NCT01130740|143104588|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||Mixed Models Analysis|||This is the between-group 12-month comparison.||||0.274
71802532|NCT01130740|143104589|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||Mixed Models Analysis|||||||0.177
71802533|NCT01208233|143104596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.735||||0.4962|TWO_SIDED|80.0|0.41|1.31|||Regression, Logistic|LOCF was used to impute missing data.||||1.31|0.41|0.4962
71802534|NCT01208233|143104596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.561||||0.2517|TWO_SIDED|80.0|0.29|1.07|||Regression, Logistic|The analysis was based on OC.||||1.07|0.29|0.2517
71841066|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.638||||0.4012|TWO_SIDED|95.0|-0.86|2.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.137|-0.860|0.4012
71841067|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.163||||0.0201|TWO_SIDED|95.0|0.343|3.983|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.983|0.343|0.0201
71841068|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.21||||0.1709|TWO_SIDED|95.0|-0.528|2.948|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||2.948|-0.528|0.1709
71841069|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.593||||0.0307|TWO_SIDED|95.0|0.15|3.035|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.035|0.150|0.0307
71841070|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.588||||0.0691|TWO_SIDED|95.0|-0.126|3.302|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.302|-0.126|0.0691
71894081|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.36||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two arms"||||0.01
71894082|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 3 between the two arms."|Difference in Change|-0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two arms"||||0.08
71894083|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two arms"||||0.08
71894084|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two arms"||||0.08
71894085|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean maintaining an erection score from period 1 to period 3 between the two arms."|Difference in Change|-0.13||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in maintaining an erection score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two arms"||||0.71
71894086|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean vomit score from period 1 to period 3 between the two arms."|Difference in Change|-0.11||||0.41|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two arms"||||0.41
71894087|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 3 between the two arms."|Difference in Change|-0.08||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two arms"||||0.84
71894088|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean urination score from period 1 to period 3 between the two arms."|Difference in Change|-0.07||||0.71|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two arms"||||0.71
71894089|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean appetite change score from period 1 to period 3 between the two arms."|Difference in Change|-0.05||||0.88|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two arms"||||0.88
71894090|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two arms"||||0.93
71894091|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two arms"||||0.93
71802535|NCT01208233|143104597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.942||0.9716|TWO_SIDED|80.0|-4.972|5.254|||Mixed Models Analysis|||Paretic hand||5.254|-4.972|0.9716
71802536|NCT01208233|143104598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.789|STANDARD_ERROR_OF_MEAN|7.2392||0.1417|TWO_SIDED|80.0|1.401|20.177|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||20.177|1.401|0.1417
71802537|NCT01208233|143104599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.33|STANDARD_ERROR_OF_MEAN|5.4241||0.0611|TWO_SIDED|80.0|-17.351|-3.31|||Mixed Models Analysis|||Paretic hand||-3.310|-17.351|0.0611
71802538|NCT01208233|143104599|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|3.2899||0.9433|TWO_SIDED|80.0|-4.011|4.48|||Mixed Models Analysis|||Non-paretic hand||4.480|-4.011|0.9433
71894092|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.94|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two arms"||||0.94
71894093|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 3 between the two arms."|Difference in Change|0.004||||0.97|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two arms"||||0.97
71894094|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean fatigue score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two arms"||||0.95
71894095|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean anxiety score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two arms"||||0.95
71894096|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean constipation score from period 1 to period 3 between the two arms."|Difference in Change|0.03||||0.93|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two arms"||||0.93
71802539|NCT01208233|143104600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.812|STANDARD_ERROR_OF_MEAN|6.8448||0.0654|TWO_SIDED|80.0|-21.668|-3.957|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)||-3.957|-21.668|0.0654
71802540|NCT01208233|143104601|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.951|TWO_SIDED|80.0|0.54|1.76|||Regression, Logistic|||LOCF was used to impute missing data.||1.76|0.54|0.9510
71802541|NCT01208233|143104602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.854||||0.7234|TWO_SIDED|80.0|0.48|1.51|||Regression, Logistic|||LOCF was used to impute missing data.||1.51|0.48|0.7234
71802542|NCT01208233|143104603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.283|STANDARD_ERROR_OF_MEAN|0.6755||0.6759|TWO_SIDED|80.0|-1.156|0.589|||Mixed Models Analysis|||||0.589|-1.156|0.6759
71802543|NCT01208233|143104604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.433||||0.4213|TWO_SIDED|80.0|0.81|2.54|||Regression, Logistic|||BI \>=95, LOCF was used to impute missing data.||2.54|0.81|0.4213
71802544|NCT01208233|143104604|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.651||||0.276|TWO_SIDED|80.0|0.92|2.98|||Regression, Logistic|||BI=100, LOCF was used to impute missing data.||2.98|0.92|0.2760
71802545|NCT01208233|143104605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.599|STANDARD_ERROR_OF_MEAN|4.4547||0.2118|TWO_SIDED|80.0|-0.15|11.348|||Mixed Models Analysis|||||11.348|-0.150|0.2118
71802546|NCT01208233|143104606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.062|STANDARD_ERROR_OF_MEAN|1.7844||0.5541|TWO_SIDED|80.0|-1.252|3.375|||Mixed Models Analysis|||||3.375|-1.252|0.5541
71802547|NCT01208233|143104607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.334|STANDARD_ERROR_OF_MEAN|0.4178||0.426|TWO_SIDED|80.0|-0.874|0.205|||Mixed Models Analysis|||||0.205|-0.874|0.4260
71802548|NCT01208233|143104608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.477|STANDARD_ERROR_OF_MEAN|5.4394||0.65|TWO_SIDED|80.0|-4.547|9.5|||Mixed Models Analysis|||(L+R)/28 × 100%||9.500|-4.547|0.6500
71802549|NCT01208233|143104608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.874|STANDARD_ERROR_OF_MEAN|6.7431||0.5671|TWO_SIDED|80.0|-4.834|12.583|||Mixed Models Analysis|||(L/14) × 100%||12.583|-4.834|0.5671
71802550|NCT01208233|143104608|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.049|STANDARD_ERROR_OF_MEAN|5.2816||0.843|TWO_SIDED|80.0|-5.771|7.87|||Mixed Models Analysis|||(R/14) × 100%||7.870|-5.771|0.8430
71802551|NCT01208233|143104609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.0733||0.1512|TWO_SIDED|80.0|0.011|0.201|||Mixed Models Analysis|||(L R)/(L+R)||0.201|0.011|0.1512
71802552|NCT01208233|143104610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.279|STANDARD_ERROR_OF_MEAN|0.5041||0.0128|TWO_SIDED|80.0|-1.929|-0.629|||Mixed Models Analysis|||||-0.629|-1.929|0.0128
71802553|NCT01208233|143104611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.1226||0.4713|TWO_SIDED|80.0|-0.07|0.248|||Mixed Models Analysis|||||0.248|-0.070|0.4713
71802554|NCT01208233|143104618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|2.7201||0.8501|TWO_SIDED|80.0|-4.026|2.995|||Mixed Models Analysis|||Non-paretic hand||2.995|-4.026|0.8501
71802555|NCT01891734|143104621|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71802556|NCT01891734|143104622|SUPERIORITY_OR_OTHER||Cohen's d|0.3|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71802557|NCT01181895|143104623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.244|TWO_SIDED|95.0|-0.048|0.188||P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.|||0.188|-0.048|0.244
71894097|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean fever score from period 1 to period 3 between the two arms."|Difference in Change|0.06||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two arms"||||0.84
71894098|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean cough score from period 1 to period 3 between the two arms."|Difference in Change|0.07||||0.84|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two arms"||||0.84
71894099|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean heartburn score from period 1 to period 3 between the two arms."|Difference in Change|0.11||||0.54|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two arms"||||0.54
71802558|NCT01181895|143104623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.926|TWO_SIDED|95.0|-0.124|0.113||P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.|||0.113|-0.124|0.926
71802559|NCT04028388|143104637|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.1465|TWO_SIDED|95.0|0.56|2.65|||Wilcoxon (Mann-Whitney)|||||2.65|0.56|0.1465
71802560|NCT04028388|143104641|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.4576|TWO_SIDED|95.0|0.39|7.93|||Log Rank|||DOR is calculated in the subpopulation of subjects experiencing a response (CR or PR). Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome.||7.93|0.39|0.4576
71802561|NCT04028388|143104642|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0776|TWO_SIDED|95.0|0.65|3.48|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome"||3.48|0.65|0.0776
71802562|NCT04028388|143104644|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.2539|TWO_SIDED|95.0|0.79|2.49|||Log Rank|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.49|0.79|0.2539
71802563|NCT04028388|143104645|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.3062|TWO_SIDED|95.0|0.76|2.42|||Wilcoxon (Mann-Whitney)|||"Difference between the cohorts is tested with Log-rank test and estimated using Univariate Cox model.~Wilcoxon test is used if proportional hazards assumption is not fulfilled. Hazard Ratio \< 1 means that tested drug (ModraDoc006/r) has better outcome."||2.42|0.76|0.3062
71802564|NCT01114516|143104683|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Log Rank|||Kaplan Meier survival analysis||||0.018
71802565|NCT01114516|143104684|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|1.06|2.05||||||||2.05|1.06|
71802566|NCT01114516|143104685|SUPERIORITY_OR_OTHER|||||||0.393|TWO_SIDED||||||Kruskal-Wallis|||||||0.393
71802567|NCT01431508|143104688|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||Comparison of Week 12 and Baseline||||<0.05
71802568|NCT00129259|143104689|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).||"Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.~Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values."||||0.002
71802569|NCT00129259|143104690|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||ANCOVA|ANCOVA adjusts for baseline HbA1c.||"Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.~Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups."||||0.697
71802570|NCT00129259|143104691|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|ANCOVA adjusts for baseline daily insulin use per kg||"Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.~Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups."||||0.110
71802571|NCT00023452|143104753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% confidence interval (CI) was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.24|||||ONE_SIDED|95.0||0.01|||||The difference in cumulative TB disease rate is the rate in the 3RPT/INH arm minus the rate in the 9INH arm.|||0.01||
71802572|NCT00023452|143104754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Rate|-0.21|||||ONE_SIDED|95.0||0.04|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.04||
71894100|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 3 between the two arms."|Difference in Change|0.14||||0.13|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two arms"||||0.13
71894101|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean clumsy score from period 1 to period 3 between the two arms."|Difference in Change|0.18||||0.18|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two arms"||||0.18
71894102|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.19||||0.29|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two arms"||||0.29
71894103|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 3 between the two arms."|Difference in Change|0.2||||0.12|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two arms"||||0.12
71894104|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 3 between the two arms."|Difference in Change|0.24||||0.1|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two arms"||||0.10
71894105|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 3 between the two arms."|Difference in Change|0.25||||0.01|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two arms"||||0.01
71894106|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 3 between the two arms."|Difference in Change|0.26||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two arms"||||0.08
71894107|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean dizziness score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.08|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two arms"||||0.08
71894108|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.09|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two arms"||||0.09
71802573|NCT00023452|143104755|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.25|||||ONE_SIDED|95.0||0.03|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.03||
71802574|NCT00023452|143104756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Chi-squared|||||||0.02
71802575|NCT00023452|143104757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24||95.0|||||Chi-squared|||Grade 3 Drug Toxicity||||0.24
71802576|NCT00023452|143104757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59||95.0|||||Chi-squared|||Grade 4 Drug Toxicity||||0.59
71802577|NCT00023452|143104758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0|||||Chi-squared|||||||0.22
71802578|NCT00023452|143104760|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71802579|NCT00023452|143104761|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71841071|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.487||||0.0034|TWO_SIDED|95.0|0.838|4.137|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.137|0.838|0.0034
71841072|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.849||||0.0034|TWO_SIDED|95.0|0.622|3.075|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.075|0.622|0.0034
71841073|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.178||||0.8123|TWO_SIDED|95.0|-1.654|1.299|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.299|-1.654|0.8123
71841074|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.48||||0.5879|TWO_SIDED|95.0|-2.226|1.267|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.267|-2.226|0.5879
71841075|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-0.596||||0.491|TWO_SIDED|95.0|-2.304|1.111|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Control is equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Control is NOT equal to zero on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.111|-2.304|0.4910
71894109|NCT03182738|143310166|SUPERIORITY|"Linear mixed models to test difference in mean depression score from period 1 to period 3 between the two arms."|Difference in Change|0.38||||0.05|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two arms"||||0.05
71894110|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-2.09||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms||||0.83
71894111|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.94||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms||||0.83
71894112|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.79||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms||||0.83
71841076|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|0.816||||0.9673|TWO_SIDED|95.0|-1.967|3.599|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||3.599|-1.967|0.9673
71841077|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.643||||0.1787|TWO_SIDED|95.0|-0.683|5.968|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.968|-0.683|0.1787
71841078|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.806||||0.5243|TWO_SIDED|95.0|-1.406|5.018|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.018|-1.406|0.5243
71841079|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|1.77||||0.3956|TWO_SIDED|95.0|-0.966|4.507|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 1 (Week 12), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.507|-0.966|0.3956
71894113|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.78||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms||||0.83
71896325|NCT03114969|143314791|SUPERIORITY||Odds Ratio (OR)|7.603||||0.188|TWO_SIDED|95.0|0.371|155.763||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||155.763|0.371|0.188
71841080|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.068||||0.381|TWO_SIDED|95.0|-1.16|5.295|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 3 (Week 18), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||5.295|-1.160|0.3810
71841081|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|3.084||||0.0557|TWO_SIDED|95.0|-0.049|6.216|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||6.216|-0.049|0.0557
71841082|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|2.445||||0.0195|TWO_SIDED|95.0|0.4|4.49|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 1 + Test 2 is NOT equal to Control on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||4.490|0.400|0.0195
71841083|NCT04800211|143191021|EQUIVALENCE|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)|Mean Difference (Net)|-1.277||||0.2817|TWO_SIDED|95.0|-3.615|1.06|||Mixed Models Analysis||LSM calculated from the MMRM includes study group, study visit, study group by study visit interaction, gender, age class, BMI class as fixed effects and baseline value as the covariate, with a variance-covariance matrix based on the AIC value.|Null hypothesis: Absolute change from Baseline for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. Alternate hypothesis: Absolute change from Baseline (Week 1) for Urine Nicotine Equivalents (mg/g creatinine) in Test 2 is NOT equal to Test 1 on Visit 5 (Week 24), relative to the start of the 12-week ALCS-RA-16-06-EV study. (mITT Population)||1.060|-3.615|0.2817
71841084|NCT05170841|143191022|SUPERIORITY||||||=|0.566|||||||t-test, 2 sided|||||||=0.566
71841085|NCT05170841|143191023|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
71841086|NCT05170841|143191024|SUPERIORITY||||||=|0.006|||||||t-test, 2 sided|||||||=0.006
71841087|NCT05170841|143191025|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
71841088|NCT05170841|143191026|SUPERIORITY||||||=|0.031|||||||t-test, 2 sided|||||||=0.031
71841089|NCT05170841|143191027|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
71841090|NCT05170841|143191028|SUPERIORITY||||||=|0.011|||||||t-test, 2 sided|||||||=0.011
71841091|NCT05170841|143191029|SUPERIORITY||||||=|0.007|||||||t-test, 2 sided|||||||=0.007
71841092|NCT05170841|143191030|SUPERIORITY||||||=|0.013|||||||t-test, 2 sided|||||||=0.013
71841093|NCT05170841|143191031|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
71841094|NCT05170841|143191032|SUPERIORITY||||||=|0.022|||||||t-test, 2 sided|||||||=0.022
71841095|NCT05170841|143191033|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71841096|NCT05170841|143191034|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71841097|NCT05170841|143191035|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
71841098|NCT05170841|143191036|SUPERIORITY||||||=|0.01|||||||t-test, 2 sided|||||||=0.01
71841099|NCT05170841|143191037|SUPERIORITY||||||=|0.04|||||||t-test, 2 sided|||||||=0.04
71841100|NCT05170841|143191038|SUPERIORITY||||||=|0.016|||||||t-test, 2 sided|||||||=0.016
71841101|NCT05170841|143191039|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
71841102|NCT05170841|143191040|SUPERIORITY||||||=|0.042|||||||t-test, 2 sided|||||||=0.042
71841103|NCT05170841|143191041|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||||||=0.037
71841104|NCT05170841|143191042|SUPERIORITY||||||=|0.045|||||||t-test, 2 sided|||||||=0.045
71841105|NCT05170841|143191043|SUPERIORITY||||||=|0.029|||||||t-test, 2 sided|||||||=0.029
71841106|NCT05170841|143191044|SUPERIORITY||||||=|0.027|||||||t-test, 2 sided|||||||=0.027
71841107|NCT05170841|143191045|SUPERIORITY||||||=|0.035|||||||t-test, 2 sided|||||||=0.035
71841108|NCT05170841|143191046|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||||||=0.001
71841109|NCT03806790|143191048|SUPERIORITY||Odds Ratio (OR)|5.8||||0.12|TWO_SIDED|95.0|0.68|49.16|||Fisher Exact|||Statistical analysis on the Full Analysis Set (FAS)||49.16|0.68|0.120
71841110|NCT03806790|143191049|SUPERIORITY||Odds Ratio (OR)|2.5||||0.004|TWO_SIDED|95.0|1.36|4.6|||Fisher Exact|||End of Week 1 (FAS)||4.60|1.36|0.004
71841111|NCT03806790|143191049|SUPERIORITY||Odds Ratio (OR)|4.85||||0.003|TWO_SIDED|95.0|1.57|14.97|||Fisher Exact|||End of Week 2 (FAS)||14.97|1.57|0.003
71841112|NCT03806790|143191050|SUPERIORITY||Estimated difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.64|-0.59|||ANOVA|||FAS||-0.59|-1.64|<0.001
71841113|NCT04865289|143191056|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.51|1.41||||||||1.41|0.51|
71841114|NCT04865289|143191057|OTHER|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.48|1.21||||||||1.21|0.48|
71841115|NCT04865289|143191058|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.17||||0.5831415|TWO_SIDED|95.0|0.64|2.15|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||2.15|0.64|0.5831415
71894114|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.04||||0.98|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm"|The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms||||0.98
71841116|NCT04865289|143191058|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6980186|TWO_SIDED|95.0|0.64|1.26|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.26|0.64|0.6980186
71841117|NCT04865289|143191059|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.52046|TWO_SIDED|95.0|0.57|1.8|||Log Rank|One-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate.|||1.80|0.57|0.52046
71896326|NCT03114969|143314792|SUPERIORITY||Odds Ratio (OR)|7.781||||0.147|TWO_SIDED|95.0|0.488|124.117||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||124.117|0.488|0.147
71841118|NCT04865289|143191060|OTHER||Difference in Percentage|-10.5||||0.8497|TWO_SIDED|95.0|-29.2|9.3|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||9.3|-29.2|0.8497
71896327|NCT03114969|143314792|SUPERIORITY||Odds Ratio (OR)|9.786||||0.12|TWO_SIDED|95.0|0.553|173.301||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||173.301|0.553|0.120
71841119|NCT04865289|143191061|OTHER||Difference in Percentage|-9.1||||0.8522|TWO_SIDED|95.0|-25.5|8.0|||Miettinen & Nurminen|One sided p value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.||||8.0|-25.5|0.8522
71841120|NCT04865289|143191062|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-2.14||||0.6138|TWO_SIDED|95.0|-10.54|6.27|||cLDA model|||||6.27|-10.54|0.6138
71841121|NCT04865289|143191063|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction.|Difference in Least Square Means|-0.73||||0.8398|TWO_SIDED|95.0|-7.93|6.46|||cLDA model|||||6.46|-7.93|0.8398
71841122|NCT06201559|143191068|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for Cmax following replicate administrations of the comparator product was \> 30%, the acceptance criteria for Cmax was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|98.1|||||TWO_SIDED|90.0|86.79|110.91|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||110.91|86.79|
71841123|NCT06201559|143191069|EQUIVALENCE|Point estimate of geometric mean ratio (GMR) of T/R should be between 80.00 -125.00%. If the intra-subject variability for AUC(0-t) following replicate administrations of the comparator product was \> 30%, the acceptance criteria for AUC(0-t) was widened to a maximum of 69.84-143.19%.|Ratio of Geometric Least Square Means|97.6|||||TWO_SIDED|90.0|86.86|109.73|||||Geometric least square means were combined to perform statistical analysis of T as T1 + T2 and R as R1 + R2.|||109.73|86.86|
71841124|NCT06122194|143191093|OTHER||Ratio of Adjusted Geometric Means|112.15|||||TWO_SIDED|90.0|93.01|135.22||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90 percent (%) confidence intervals (CIs) were expressed as percentages.||135.22|93.01|
71841125|NCT06122194|143191093|OTHER||Ratio of Adjusted Geometric Means|187.37|||||TWO_SIDED|90.0|155.79|225.35||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||225.35|155.79|
71841126|NCT06122194|143191093|OTHER||Ratio of Adjusted Geometric Means|153.61|||||TWO_SIDED|90.0|127.4|185.21||||||Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||185.21|127.40|
71896328|NCT03114969|143314793|SUPERIORITY||Odds Ratio (OR)|2.089||||0.395|TWO_SIDED|95.0|0.383|11.389||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||11.389|0.383|0.395
71802580|NCT00023452|143104762|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood's formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.19|||||ONE_SIDED|95.0||0.06|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.|||0.06||
71802581|NCT02939105|143104790|OTHER||success proportion|86.7|||||TWO_SIDED|95.0|69.3|96.2||||||||96.2|69.3|
71802582|NCT01940705|143104792|SUPERIORITY||Mean Difference (Final Values)|5.578||||0.001|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Skills scale||||0.001
71802583|NCT01940705|143104792|SUPERIORITY||Mean Difference (Final Values)|4.235||||0.003|TWO_SIDED||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Knowledge scale||||0.003
71802584|NCT01940705|143104793|SUPERIORITY||Mean Difference (Final Values)|0.956||||0.414|TWO_SIDED||||||ANOVA|||||||0.414
71802585|NCT01940705|143104794|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.847|TWO_SIDED||||||ANOVA|||||||0.847
71802586|NCT00139997|143104795|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|||||||0.028
71802587|NCT05955560|143104826|SUPERIORITY|||||||0.04||||||A two-sided paired t-test was used and p-value derived. The threshold for statistical significance was p \< 0.05|t-test, 2 sided|||||||0.04
71802588|NCT04621500|143104831|OTHER|The sequencing transcriptional profile cannot be analyzed by a statistical method.|||||||||||||||||In this open label study, the RNA sequencing transcription analysis was performed to assess if the transcriptome would be modified by vitamin D supplementation and it uniformaly was.|||
71802589|NCT01040871|143104897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.915|TWO_SIDED|95.0|0.529|2.037|||Cochran-Mantel-Haenszel|Stratified by IPI score|Odds ratio: VR-CAP CR rate relative to R-CHOP CR rate|||2.037|0.529|0.915
71802590|NCT02451748|143104905|EQUIVALENCE|ANOVA||||||0.5378||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.5378
71802591|NCT02451748|143104905|EQUIVALENCE|ANOVA||||||0.919||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.919
71802592|NCT02451748|143104905|EQUIVALENCE|ANOVA||||||0.4255||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7 was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.4255
71802593|NCT02451748|143104905|EQUIVALENCE|ANOVA||||||0.1037||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and second visit is as follows.||||0.1037
71802594|NCT02451748|143104905|EQUIVALENCE|ANOVA||||||0.0008||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the first and third visit is as follows.||||0.0008
71802595|NCT02451748|143104905|EQUIVALENCE|ANOVA||||||0.0001||||||Tukey adjustment for multiple comparisons|ANOVA|A priori threshold was \<0.05.||The mean mRNA expression for IL-7R was compared between all three visits simultaneously in RA Peripheral Blood Nonnuclear Cells. The comparison between the second and third visit is as follows.||||0.0001
71802596|NCT00673049|143104922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.091||||0.35|TWO_SIDED|95.0|0.909|1.31||One-sided significance level at alpha=0.024 was used. Two-sided p-value was reported.|Log Rank|Nominal p-values were reported without adjustment for the interim analysis.||P-value was calculated using log-rank test stratified by gender (Male or Female), Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.310|0.909|0.35
71814110|NCT01889186|143130365|SUPERIORITY||||||<|0.001|||||||Clopper-Pearson exact method|||The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.||||<0.001
71814111|NCT01257880|143130379|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.||||0.39
71814112|NCT03802864|143130385|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71814113|NCT03802864|143130386|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
71814114|NCT03802864|143130387|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71814115|NCT03802864|143130388|SUPERIORITY|||||||0.28|||||||Regression, Linear|||||||0.28
71814116|NCT03802864|143130389|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
71814117|NCT03802864|143130390|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71814118|NCT03802864|143130391|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71814119|NCT04710927|143130423|OTHER||Odds Ratio (OR)|0.7|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71814120|NCT04710927|143130423|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71841127|NCT06122194|143191094|OTHER||Ratio of Adjusted Geometric Means|102.59|||||TWO_SIDED|90.0|91.09|115.54||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||115.54|91.09|
71841128|NCT06122194|143191094|OTHER||Ratio of Adjusted Geometric Means|125.07|||||TWO_SIDED|90.0|110.81|141.17||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||141.17|110.81|
71841129|NCT06122194|143191094|OTHER||Ratio of Adjusted Geometric Means|121.75|||||TWO_SIDED|90.0|108.65|136.43||||||Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.||136.43|108.65|
71841130|NCT04248725|143191121|SUPERIORITY||Mean Difference (Net)|-2.7||||0.004|TWO_SIDED||||||Mixed Models Analysis|Models were adjusted for sex, baseline severity, and disability condition.||||||0.004
71841131|NCT04248725|143191122|SUPERIORITY||Mean Difference (Net)|0.59|||<|0.001|TWO_SIDED|95.0|0.3|0.88|||Mixed Models Analysis|||||0.88|0.30|<0.001
71841132|NCT04248725|143191123|SUPERIORITY||Mean Difference (Net)|-0.32||||0.29|TWO_SIDED|95.0|-0.61|-0.03|||Mixed Models Analysis|||||-0.03|-0.61|0.29
71841133|NCT05622812|143191124|SUPERIORITY||Treatment difference|39.0|||<|0.001|TWO_SIDED|95.0|21.6|56.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||56.5|21.6|<0.001
71841134|NCT05622812|143191125|SUPERIORITY||Treatment difference|40.4|||<|0.001|TWO_SIDED|95.0|23.1|57.6||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||57.6|23.1|<0.001
71841135|NCT05622812|143191125|SUPERIORITY||Treatment difference|41.7|||<|0.001|TWO_SIDED|95.0|25.6|57.8||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||57.8|25.6|<0.001
71841136|NCT05622812|143191125|SUPERIORITY||Treatment difference|30.2||||0.003|TWO_SIDED|95.0|13.2|47.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||47.1|13.2|0.003
71841137|NCT05622812|143191126|SUPERIORITY||Treatment difference|99.0|||<|0.001|TWO_SIDED|95.0|97.1|100.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||100.0|97.1|<0.001
71841138|NCT05622812|143191126|SUPERIORITY||Treatment difference|87.6|||<|0.001|TWO_SIDED|95.0|76.9|98.2||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||98.2|76.9|<0.001
71841139|NCT05622812|143191126|SUPERIORITY||Treatment difference|80.5|||<|0.001|TWO_SIDED|95.0|68.6|92.4||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 9||92.4|68.6|<0.001
71894115|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.55||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.||||0.83
71841140|NCT05622812|143191126|SUPERIORITY||Treatment difference|73.7|||<|0.001|TWO_SIDED|95.0|61.9|85.5||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||85.5|61.9|<0.001
71841141|NCT05622812|143191127|SUPERIORITY||Treatment difference|93.1|||<|0.001|TWO_SIDED|95.0|88.2|98.0||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 3||98.0|88.2|<0.001
71841142|NCT05622812|143191127|SUPERIORITY||Treatment difference|87.9|||<|0.001|TWO_SIDED|95.0|81.4|94.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 6||94.3|81.4|<0.001
71841143|NCT05622812|143191127|SUPERIORITY||Treatment difference|80.4|||<|0.001|TWO_SIDED|95.0|72.7|88.1||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|||88.1|72.7|<0.001
71841144|NCT05622812|143191127|SUPERIORITY||Treatment difference|71.6|||<|0.001|TWO_SIDED|95.0|62.8|80.3||Two-sided p-value calculated using Fisher's Exact Test. The threshold of significance at \<0.05.|Fisher's Exact Test.||Difference confidence interval calculated using normal approximation.|Month 12||80.3|62.8|<0.001
71841145|NCT03916185|143191128|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-32.0|32.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||32|-32|>0.99
71841146|NCT03916185|143191128|SUPERIORITY||Difference in proportions|-15.0||||0.53|TWO_SIDED|95.0|-46.0|18.0||Statistical significance level of 0.05 used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-46|0.53
71841147|NCT03916185|143191128|SUPERIORITY||Difference in proportions|16.0||||0.66|TWO_SIDED|95.0|-29.0|52.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||52|-29|0.66
71841148|NCT03916185|143191129|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-20.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||20|-20|>0.99
71802597|NCT00673049|143104923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075||||0.426|TWO_SIDED|95.0|0.898|1.287||One-sided significance level at alpha=0.001 was used. Two-sided p-value was reported.|Log Rank|||P-value was calculated using log-rank test stratified by gender (Male or Female), ECOG performance status (less than or equal to \[=\<1\] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.||1.287|0.898|0.426
71802598|NCT00673049|143104924|SUPERIORITY_OR_OTHER||Difference in response rates|1.668||||0.338|TWO_SIDED|95.0|-1.7|5.1|||Chi-squared|||||5.1|-1.7|0.338
71802599|NCT00924950|143104932|SUPERIORITY||Mean Difference (Final Values)|0.8571||||0.0008|TWO_SIDED||||||t-test, 2 sided|||||||0.0008
71802600|NCT04193202|143104934|SUPERIORITY||Estimated difference|0.75||||0.034|TWO_SIDED|95.0|0.06|1.44|||Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline LCQ total score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12|||1.44|0.06|0.034
71802601|NCT04193202|143104935|OTHER||Estimated Difference|-6.92||||0.006|TWO_SIDED|95.0|-11.88|-1.97||Nominal p value, not controlled for multiplicity|Longitudinal ANCOVA|The model included terms for treatment group, visit, interaction of treatment by visit, gender, and baseline mean weekly cough severity VAS score.|The estimated difference is the treatment difference in model based mean change from baseline at Week 12.|||-1.97|-11.88|0.006
71802602|NCT02979535|143104938|OTHER||GMT ratio|0.947|||||TWO_SIDED|95.0|0.773|1.16||||||Antigen HPV-16||1.16|0.773|
71802603|NCT02979535|143104938|OTHER||GMT ratio|0.986|||||TWO_SIDED|95.0|0.803|1.21||||||Antigen HPV-18||1.21|0.803|
71802604|NCT02979535|143104939|OTHER||GMT ratio|0.977|||||TWO_SIDED|95.0|0.653|1.46||||||Dengue Virus Serotype 1||1.46|0.653|
71802605|NCT02979535|143104939|OTHER||GMT ratio|0.911|||||TWO_SIDED|95.0|0.654|1.27||||||Dengue Virus Serotype 2||1.27|0.654|
71802606|NCT02979535|143104939|OTHER||GMT ratio|0.921|||||TWO_SIDED|95.0|0.727|1.17||||||Dengue Virus Serotype 3||1.17|0.727|
71802607|NCT02979535|143104939|OTHER||GMT ratio|0.931|||||TWO_SIDED|95.0|0.733|1.18||||||Dengue Virus Serotype 4||1.18|0.733|
71802608|NCT04820673|143104953|OTHER||||||<|0.0001||||||P\<0.0001, calculated by t-test, corresponds to baseline response group domain scores in comparison to week-12 domain scores (CFB). CFB is calculated using available matching data for each domain. Higher domain scores indicate higher disease burden.|t-test, 2 sided|||Week 12 vs Baseline||||<.0001
71802609|NCT00587587|143104959|SUPERIORITY_OR_OTHER|||||||1||||||"P-value compares overall incidence of AEs between groups, ie Apligraf 12/17 and Control 10/13.~UADE is defined in 21CFR812.3(s)"|Fisher Exact|||Fisher's exact test used to evaluate treatment differences between Apligraf subjects and Control subjects experiencing any AEs.||||1.0000
71802610|NCT00587587|143104960|SUPERIORITY_OR_OTHER|||||||0.5863||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5863
71802611|NCT00587587|143104961|SUPERIORITY_OR_OTHER|||||||0.3783||95.0|||||Fisher Exact|||||||0.3783
71802612|NCT00587587|143104962|SUPERIORITY_OR_OTHER|||||||0.7149|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar firmness evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7149
71802613|NCT00587587|143104963|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar thickness evaluated using a 2-tailed Wilcoxon rank sum test||||0.1670
71802614|NCT00587587|143104964|SUPERIORITY_OR_OTHER|||||||0.7221|TWO_SIDED|0.0|||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.7221
71802615|NCT00587587|143104965|SUPERIORITY_OR_OTHER|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.4080
71802616|NCT00587587|143104966|SUPERIORITY_OR_OTHER|||||||0.9556||0.0|||||Wilcoxon (Mann-Whitney)|||Differences evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.||||0.9556
71802617|NCT00767000|143104985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51|||<|0.001||95.0|-0.8|-0.22|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.22|-0.80|<0.001
71802618|NCT00767000|143104985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|||<|0.001||95.0|-0.93|-0.36|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.36|-0.93|<0.001
71802619|NCT00767000|143104985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|||<|0.001||95.0|-1.1|-0.53|||Contrained longitudinal model|||Analysis for change from baseline to Week 14||-0.53|-1.10|<0.001
71802620|NCT00767000|143104985|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.75|||<|0.001||95.0|-1.04|-0.46|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-0.46|-1.04|<0.001
71802621|NCT00767000|143104986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.6|||<|0.001||95.0|-55.6|-17.5|||Constrained longitudial model|||Analysis for change from baseline to Week 14||-17.5|-55.6|<0.001
71802622|NCT00767000|143104986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-26.7||||0.005||95.0|-45.4|-8.1|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-8.1|-45.4|0.005
71802623|NCT00767000|143104986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-35.0|||<|0.001||95.0|-54.0|-16.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-16.0|-54.0|<0.001
71802624|NCT00767000|143104986|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-36.9|||<|0.001||95.0|-55.9|-17.9|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||-17.9|-55.9|<0.001
71802625|NCT00767000|143104987|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.8||||0.791||95.0|-11.6|15.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||15.2|-11.6|0.791
71802626|NCT00767000|143104987|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.3||||0.121||95.0|-2.7|23.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||23.2|-2.7|0.121
71802627|NCT00767000|143104987|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-9.3||||0.169||95.0|-22.6|4.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||4.0|-22.6|0.169
71802628|NCT00767000|143104987|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.7||||0.321||95.0|-6.6|20.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14||20.0|-6.6|0.321
71894116|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.84||||0.83|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.||||0.83
71802629|NCT02039505|143105001|SUPERIORITY||Adjusted Odds Ratio|1.37||||0.2722|TWO_SIDED|95.0|0.779|2.399|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||2.399|0.779|0.2722
71802630|NCT02039505|143105002|SUPERIORITY||Adjusted Odds Ratio|2.88||||0.021|TWO_SIDED|95.0|1.168|7.108|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||7.108|1.168|0.0210
71802631|NCT02039505|143105008|SUPERIORITY||Adjusted Odds Ratio|1.66||||0.198|TWO_SIDED|95.0|0.762|3.596|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||3.596|0.762|0.1980
71802632|NCT02039505|143105009|SUPERIORITY||Adjusted Odds Ratio|1.33||||0.3168|TWO_SIDED|95.0|0.755|2.356|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||2.356|0.755|0.3168
71802633|NCT02039505|143105010|SUPERIORITY||Adjusted Odds Ratio|3.48||||0.0067|TWO_SIDED|95.0|1.407|8.626|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.626|1.407|0.0067
71802634|NCT02039505|143105011|SUPERIORITY||Adjusted Odds Ratio|3.49||||0.0066|TWO_SIDED|95.0|1.409|8.642|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||8.642|1.409|0.0066
71802635|NCT02039505|143105012|SUPERIORITY||Adjusted Odds Ratio|2.02||||0.209|TWO_SIDED|95.0|0.677|6.033|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||6.033|0.677|0.2090
71802636|NCT02039505|143105013|SUPERIORITY||Adjusted Odds Ratio|3.38||||0.1571|TWO_SIDED|95.0|0.636|17.981|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.|||17.981|0.636|0.1571
71802637|NCT04564833|143105021|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71802638|NCT04564833|143105021|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71802639|NCT04564833|143105022|SUPERIORITY|||||||0.3954|||||||ANCOVA|||||||0.3954
71802640|NCT04564833|143105022|SUPERIORITY|||||||0.0682|||||||ANCOVA|||||||0.0682
71802641|NCT04564833|143105023|SUPERIORITY|||||||0.6755|||||||Fisher Exact|||||||0.6755
71802642|NCT04564833|143105023|SUPERIORITY|||||||0.6758|||||||Fisher Exact|||||||0.6758
71802643|NCT04564833|143105024|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71802644|NCT04564833|143105024|SUPERIORITY||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71802645|NCT04265755|143105025|OTHER|Adjusted analysis utilizes a logistic regression model which includes age, sex, dose switch, Baseline value of interest, and mPRS as covariates and presents the mPRS estimates.|Odds Ratio (OR)|1.01||||0.86|TWO_SIDED|95.0|0.9|1.13|||Regression, Logistic||Based on a 1 standard deviation increase in mPRS.|Odds of achieving at least 50% reduction from Baseline in mean MMD over months 4, 5, and 6 in relation to mPRS.||1.13|0.90|0.86
71802646|NCT00097591|143105028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.002|TWO_SIDED|95.0|0.726|0.927||The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.|Gehan-Wilcoxon|||For UA/NSTEMI population||0.927|0.726|0.002
71802647|NCT00097591|143105028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.793||||0.019|TWO_SIDED|95.0|0.649|0.968|||Gehan-Wilcoxon|||For STEMI population||0.968|0.649|0.019
71802648|NCT00097591|143105028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.812|||<|0.001|TWO_SIDED|95.0|0.732|0.902|||Gehan-Wilcoxon|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For All ACS population||0.902|0.732|<0.001
71802649|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.314||||0.002|TWO_SIDED|95.0|1.107|1.559|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major or Minor Bleeding||1.559|1.107|0.002
71802650|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.315||||0.029|TWO_SIDED|95.0|1.028|1.683|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major Bleeding||1.683|1.028|0.029
71802651|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.517||||0.015|TWO_SIDED|95.0|1.083|2.126|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)||2.126|1.083|0.015
71802652|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.191||||0.002|TWO_SIDED|95.0|1.158|11.113|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Fatal||11.113|1.1580|0.002
71802653|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.119||||0.736|TWO_SIDED|95.0|0.582|2.152|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)||2.152|0.582|0.736
71802654|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.617||||0.016|TWO_SIDED|95.0|1.159|5.908|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes||5.908|1.159|0.016
71802655|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.998||||0.995|TWO_SIDED|95.0|0.528|1.885|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention||1.885|0.528|0.995
71802656|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.499||||0.084|TWO_SIDED|95.0|0.945|2.379|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (\>=4 units)||2.379|0.945|0.084
71802657|NCT00097591|143105029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.313||||0.022|TWO_SIDED|95.0|1.04|1.656|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Minor Bleeding||1.656|1.040|0.022
71802658|NCT00097591|143105030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.784|||<|0.001|TWO_SIDED|95.0|0.688|0.894|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.894|0.688|<0.001
71802659|NCT00097591|143105030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.794|||<|0.001|TWO_SIDED|95.0|0.703|0.896|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.896|0.703|<0.001
71802660|NCT00097591|143105031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.672|0.876|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days||0.876|0.672|<0.001
71802661|NCT00097591|143105031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797|||<|0.001|TWO_SIDED|95.0|0.705|0.901|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days||0.901|0.705|<0.001
71802662|NCT00097591|143105032|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.838|||<|0.001|TWO_SIDED|95.0|0.762|0.921|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.921|0.762|<0.001
71802663|NCT00097591|143105033|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831|||<|0.001|TWO_SIDED|95.0|0.751|0.919|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||||0.919|0.751|<0.001
71802664|NCT01282710|143105041|SUPERIORITY_OR_OTHER|||||||0.04627||95.0|||||Mixed Models Analysis|||"Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||.04627
71802665|NCT01282710|143105041|SUPERIORITY_OR_OTHER|||||||0.1676||95.0|||||Mixed Models Analysis|||"Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."||||0.1676
71802666|NCT02504645|143105042|SUPERIORITY|||||||0.2631|TWO_SIDED|0.0|||||Chi-squared|||||||0.2631
71802667|NCT02753751|143105048|SUPERIORITY|The Mantel-Haenszel test was used, accounting for each hospital as an individual stratum, and to obtain the pooled relative risks across hospitals without adjusting for other baseline factors. (Alert arm is the numerator, control arm is the denominator.) Patients discharged prior to 14 days without an outcome of interest were assumed to be free of that outcome at 14 days. A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Risk Ratio (RR)|1.02||||0.67|TWO_SIDED|95.0|0.93|1.13||A p-value of \<=0.04 was considered statistically significant to account for the interim analysis.|Cochran-Mantel-Haenszel|||In our retrospective analysis of patients with AKI at 3 potential study hospitals, the composite outcome was 24.5%. A clinically meaningful relative reduction in this risk would be 20%. 5,024 patients (2,512 in each group) would have 90% power to detect a difference in outcome at least this extreme at a two-sided alpha of 0.05 as calculated using the Cochran-Mantel-Haenszel test. We have elected to increase this number by 20% to account for potential contamination.||1.13|0.93|0.67
71802668|NCT00718042|143105057|SUPERIORITY_OR_OTHER||Specificity|99.86|||||TWO_SIDED|95.0|99.79|99.91|||Point Estimate||Numerator = All blood donors tested nonreactive from all True Negative blood donors (16,223) Denominator = All True Negative blood donors (16,246) True Negative excludes donor specimens positive by supplemental testing (3)|||99.91|99.79|
71802669|NCT00718042|143105059|SUPERIORITY_OR_OTHER||Point estimate|100.0|||||TWO_SIDED|95.0|96.7|100.0|||Sensitivity|||||100.00|96.70|
71802670|NCT00718042|143105062|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|97.4|99.8|||Percentage Negative|||||99.8|97.4|
71802671|NCT00614939|143105066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.151||0.007|TWO_SIDED|95.0|-0.71|-0.12|||ANCOVA|\*Adjusted for baseline HbA1c||||-0.12|-0.71|0.007
71802672|NCT00614939|143105067|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.34|STANDARD_ERROR_OF_MEAN|12.847||0.339||95.0|-37.91|13.22|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||13.22|-37.91|0.339
71802673|NCT00614939|143105068|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.36|STANDARD_ERROR_OF_MEAN|16.938||0.798|TWO_SIDED|95.0|-38.65|29.93|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||29.93|-38.65|0.798
71802674|NCT00614939|143105069|SUPERIORITY_OR_OTHER||Mean Difference (Net)|44.01|STANDARD_ERROR_OF_MEAN|30.815||0.164|TWO_SIDED|95.0|-18.93|106.94|||ANCOVA|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||106.94|-18.93|0.164
71841149|NCT03916185|143191129|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-25.0|13.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||13|-25|>0.99
71841150|NCT03916185|143191129|SUPERIORITY||Difference in proportions|-5.0|||>|0.99|TWO_SIDED|95.0|-26.0|34.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||34|-26|>0.99
71841151|NCT03916185|143191130|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
71841152|NCT03916185|143191130|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-18.0|18.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||18|-18|>0.99
71894117|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|-0.43||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.||||0.96
71894118|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.07||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.||||0.96
71894119|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.23||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model|||The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|||0.96
71802675|NCT00614939|143105070|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.713|||TWO_SIDED|95.0|-2.1|0.74|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||0.74|-2.10|
71802676|NCT00614939|143105071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.941|||TWO_SIDED|95.0|-2.14|1.67|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.67|-2.14|
71802677|NCT00614939|143105072|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.44|STANDARD_ERROR_OF_MEAN|1.709|||TWO_SIDED|95.0|-1.05|5.93|||Footnote|\*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||5.93|-1.05|
71802678|NCT00614939|143105073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|-1.27|-0.37|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=26 for saxagliptin and n=34 for placebo~\*Adjusted for baseline HbA1c"||||-0.37|-1.27|
71802679|NCT00614939|143105074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.98|STANDARD_ERROR_OF_MEAN|18.475|||TWO_SIDED|95.0|-54.28|18.33|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||18.33|-54.28|
71802680|NCT00614939|143105075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.73|STANDARD_ERROR_OF_MEAN|25.326|||TWO_SIDED|95.0|-65.77|34.3|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||34.30|-65.77|
71802681|NCT00614939|143105076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-38.09|STANDARD_ERROR_OF_MEAN|53.822|||TWO_SIDED|95.0|-144.44|68.26|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||68.26|-144.44|
71802682|NCT00614939|143105077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.027|||TWO_SIDED|95.0|-2.99|1.04|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=17 for saxagliptin and n=16 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.04|-2.99|
71802683|NCT00614939|143105078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.405|||TWO_SIDED|95.0|-3.66|1.89|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=5 for saxagliptin and n=11 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||1.89|-3.66|
71802684|NCT00614939|143105079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14|STANDARD_ERROR_OF_MEAN|2.985|||TWO_SIDED|95.0|-8.04|3.76|||Repeated Measures|"Number of subjects with observed values at Week 52 was n=2 for saxagliptin and n=5 for placebo.~\*Adjusted for baseline FPG"||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."||3.76|-8.04|
71802685|NCT01070810|143105086|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
71894120|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.77||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.||||0.96
71802686|NCT01070810|143105087|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.97|TWO_SIDED|95.0|0.61|1.62|||Regression, Cox|||Time to shock reversal was complicated by a high incidence of death prior to the event. To account for this we classified death as a competing risk event and used the estimated cumulative incidence function (CIF) to illustrate the comparison of CIFs between the two treatment groups using the Fine-Gray competing risk model. We tested the subdistribution hazards of these two CIF functions and obtained the estimated hazard ratio with 95% confidence intervals.||1.62|0.61|0.97
71802687|NCT01070810|143105088|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71802688|NCT01070810|143105089|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71802689|NCT01070810|143105090|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
71802690|NCT05061446|143105098|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
71802691|NCT05061446|143105098|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
71802692|NCT05061446|143105099|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
71802693|NCT05061446|143105099|OTHER||Difference in percentage|26.3|||||TWO_SIDED|95.0|6.52|46.12||||||||46.12|6.52|
71802694|NCT05061446|143105100|OTHER||Difference in percentage|20.0|||||TWO_SIDED|95.0|-0.24|40.24||||||||40.24|-0.24|
71802695|NCT05061446|143105100|OTHER||Difference in percentage|31.6|||||TWO_SIDED|95.0|10.68|52.48||||||||52.48|10.68|
71802696|NCT05061446|143105101|OTHER||Difference in percentage|6.7|||||TWO_SIDED|95.0|-5.96|19.29||||||||19.29|-5.96|
71802697|NCT05061446|143105101|OTHER||Difference in percentage|5.3|||||TWO_SIDED|95.0|-4.78|15.3||||||||15.30|-4.78|
71802698|NCT05061446|143105102|OTHER||Difference in percentage|26.2|||||TWO_SIDED|95.0|-1.22|53.6||||||||53.60|-1.22|
71802699|NCT05061446|143105102|OTHER||Difference in percentage|45.5|||||TWO_SIDED|95.0|19.3|71.68||||||||71.68|19.30|
71802700|NCT03880578|143105105|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|The outcome measure is change over time between treatment groups, reported as a mean adjusted difference.|change in the composite score of the ThyPRO between groups|||-5.7|-14.9|<0.001
71802701|NCT03880578|143105106|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.06|TWO_SIDED|95.0|-4.34|0.06|||Mixed Models Analysis|||||0.06|-4.34|0.06
71802702|NCT03880578|143105107|SUPERIORITY||Median Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.27|2.03|||Mixed Models Analysis||MAD obtained after log transformation of TSH|||2.03|1.27|<0.001
71802703|NCT03880578|143105108|SUPERIORITY||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Mixed Models Analysis|||FT3||-0.35|-0.87|<0.001
71802704|NCT03880578|143105108|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.12|TWO_SIDED|95.0|-1.81|0.15|||Mixed Models Analysis|||FT4||0.15|-1.81|0.12
71802705|NCT03880578|143105109|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-14.6|-8.5|||Mixed Models Analysis|||||-8.5|-14.6|<0.001
71802706|NCT03299192|143105129|SUPERIORITY|||||||0.001||||||This feasibility study is small and not designed to look at outcome statistics|GEE with Ancova features|||||||.001
71802707|NCT01418209|143105132|SUPERIORITY_OR_OTHER|||||||0.02||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
71802708|NCT01418209|143105132|SUPERIORITY_OR_OTHER|||||||0.02||||||p-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold of statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.02
71802709|NCT01418209|143105133|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||<0.001
71802710|NCT01418209|143105133|SUPERIORITY_OR_OTHER|||||||0.005||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.||||0.005
71802711|NCT01418209|143105135|SUPERIORITY_OR_OTHER|||||||0.01||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.01
71814121|NCT02007434|143130442|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.24|STANDARD_ERROR_OF_MEAN|0.59||0.6803|TWO_SIDED|95.0|-0.93|1.41|||ANCOVA||Paradigm 1 - Paradigm 2|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.41|-0.93|0.6803
71802712|NCT01418209|143105135|SUPERIORITY_OR_OTHER|||||||0.07||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.07
71841153|NCT03916185|143191130|SUPERIORITY||Difference in proportions|0.0|||>|0.99|TWO_SIDED|95.0|-17.0|41.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||41|-17|>0.99
71841154|NCT03916185|143191131|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustment for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
71841155|NCT03916185|143191131|SUPERIORITY||Difference in proportions|56.0|||<|0.001|TWO_SIDED|95.0|22.0|79.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Comparison was vaccine arm - placebo.|||79|22|<0.001
71841156|NCT03916185|143191131|SUPERIORITY||Difference in proportions|56.0||||0.011|TWO_SIDED|95.0|9.0|86.0|||Fisher Exact|Statistical significance level of 0.05 was used. No adjustments were made for multiple comparisons.|Comparison was vaccine arm - placebo.|||86|9|0.011
71841157|NCT03916185|143191131|SUPERIORITY||Difference in proportions|6.0|||>|0.99|TWO_SIDED|95.0|-25.0|36.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||36|-25|>0.99
71841158|NCT03916185|143191131|SUPERIORITY||Difference in proportions|5.0|||>|0.99|TWO_SIDED|95.0|-31.0|48.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||48|-31|>0.99
71841159|NCT03916185|143191131|SUPERIORITY||Difference in proportions|-1.0|||>|0.99|TWO_SIDED|95.0|-38.0|44.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||44|-38|>0.99
71802713|NCT01418209|143105137|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo.||||<0.001
71802714|NCT01418209|143105137|SUPERIORITY_OR_OTHER|||||||0.03||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo||||0.03
71802715|NCT04737538|143105139|OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-13.3|-8.8|||Non-parametric method (Van Elteren test)|||||-8.8|-13.3|<0.0001
71802716|NCT04737538|143105140|OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.01||0.4488|TWO_SIDED|95.0|-1.6|2.4|||Non-parametric method (Van Elteren test)|||||2.4|-1.6|0.4488
71841160|NCT03916185|143191132|SUPERIORITY||Difference in proportions|73.0|||<|0.001|TWO_SIDED|95.0|44.0|91.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||91|44|<0.001
71841161|NCT03916185|143191132|SUPERIORITY||Difference in proportions|61.0|||<|0.001|TWO_SIDED|95.0|27.0|83.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||83|27|<0.001
71841162|NCT03916185|143191132|SUPERIORITY||Difference in proportions|85.0|||<|0.001|TWO_SIDED|95.0|42.0|97.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was vaccine arm - placebo.|||97|42|<0.001
71841163|NCT03916185|143191132|SUPERIORITY||Difference in proportions|12.0||||0.66|TWO_SIDED|95.0|-17.0|40.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 6120/ΔNS2/1030s Vaccine.|||40|-17|0.66
71841164|NCT03916185|143191132|SUPERIORITY||Difference in proportions|-12.0|||>|0.99|TWO_SIDED|95.0|-36.0|30.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV ΔNS2/Δ1313/I1314L Vaccine - RSV 276 Vaccine.|||30|-36|>0.99
71802717|NCT04737538|143105141|OTHER||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.18|<|0.0001|TWO_SIDED|95.0|-13.8|-9.1|||Non-parametric method (Van Elteren test)|||||-9.1|-13.8|<0.0001
71802718|NCT00560833|143105142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|||<|0.01|TWO_SIDED|95.0|-2.3|-0.4||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.4|-2.3|<0.01
71802719|NCT00560833|143105142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||<|0.01|TWO_SIDED|95.0|-3.1|-1.2||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.2|-3.1|<0.01
71802720|NCT00560833|143105142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
71841165|NCT03916185|143191132|SUPERIORITY||Difference in proportions|-24.0||||0.28|TWO_SIDED|95.0|-50.0|20.0||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Fisher Exact||Comparison was RSV 6120/ΔNS2/1030s Vaccine - RSV 276 Vaccine.|||20|-50|0.28
71841166|NCT03916185|143191133|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71841167|NCT03916185|143191133|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71841168|NCT03916185|143191133|SUPERIORITY||||||<|0.001||||||Statistical significance of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71802721|NCT00560833|143105142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-1.0|-2.9|<0.01
71802722|NCT00560833|143105144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.06|TWO_SIDED|95.0|-2.0|0.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.0|-2.0|0.06
71802723|NCT00560833|143105144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|||<|0.01|TWO_SIDED|95.0|-3.0|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-3.0|<0.01
71802724|NCT00560833|143105144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|||<|0.01|TWO_SIDED|95.0|-2.9|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.9|-2.9|<0.01
71802725|NCT00560833|143105144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||<|0.01|TWO_SIDED|95.0|-2.6|-0.5||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.5|-2.6|<0.01
71802726|NCT00560833|143105145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.62|TWO_SIDED|95.0|-0.09|0.03||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.03|-0.09|0.62
71802727|NCT00560833|143105145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
71802728|NCT00560833|143105145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.01|TWO_SIDED|95.0|-0.13|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.13|0.01
71802729|NCT00560833|143105145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.02|TWO_SIDED|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||-0.01|-0.12|0.02
71802730|NCT00560833|143105146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||1|TWO_SIDED|95.0|-0.06|0.07||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.07|-0.06|1.0
71802731|NCT00560833|143105146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.72|TWO_SIDED|95.0|-0.09|0.04||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.04|-0.09|0.72
71802732|NCT00560833|143105146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.13|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.13
71802733|NCT00560833|143105146|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.15|TWO_SIDED|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA|||||0.01|-0.12|0.15
71802734|NCT00019682|143105158|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
71802735|NCT00019682|143105159|SUPERIORITY|||||||0.008||||||Unadjusted 2 tail p value.|Log Rank|||||||0.008
71802736|NCT00019682|143105160|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71802737|NCT00019682|143105161|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-G scale||||>0.05
71802738|NCT00019682|143105161|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-F scale||||>0.05
71802739|NCT00019682|143105161|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SF-36 scale||||>0.05
71802740|NCT00019682|143105161|NON_INFERIORITY|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SDS scale||||>0.05
71802741|NCT02199691|143105162|NON_INFERIORITY|95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|9.2|||||TWO_SIDED|95.0|3.4|15.0||||||Serogroup A||15|3.4|
71802742|NCT02199691|143105162|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|24.6|||||TWO_SIDED|95.0|20.3|29.0||||||Serogroup C||29|20.3|
71802743|NCT02199691|143105162|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|16.2|||||TWO_SIDED|95.0|12.3|20.2||||||||20.2|12.3|
71802744|NCT02199691|143105162|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|19.6|||||TWO_SIDED|95.0|14.2|24.8||||||Serogroup W||24.8|14.2|
71802745|NCT02199691|143105163|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|5.0|||||TWO_SIDED|95.0|-0.8|10.5||||||Serogroup A||10.5|-0.8|
71802746|NCT02199691|143105163|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.5|2.4||||||Serogroup C||2.4|-2.5|
71802747|NCT02199691|143105163|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.3|1.2||||||Serogroup Y||1.2|-4.3|
71841169|NCT03916185|143191133|SUPERIORITY|||||||0.95||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.95
71802748|NCT02199691|143105163|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \> -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-7.3|2.6||||||Serogroup W||2.6|-7.3|
71802749|NCT02199691|143105164|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.845|||||TWO_SIDED|95.0|0.722|0.99||||||PT: Geometric Mean Ratio||0.99|0.722|
71802750|NCT02199691|143105164|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.746|||||TWO_SIDED|95.0|0.661|0.842||||||FHA: Geometric Mean Ratio||0.842|0.661|
71802751|NCT02199691|143105164|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.753|||||TWO_SIDED|95.0|0.627|0.903||||||PRN: Geometric Mean Ratio||0.903|0.627|
71802752|NCT02199691|143105164|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio was \>2/3.|Geometric Mean Ratio|0.679|||||TWO_SIDED|95.0|0.525|0.878||||||FIM: Geometric Mean Ratio||0.878|0.525|
71802753|NCT02199691|143105165|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|-1.1|||||TWO_SIDED|95.0|-3.3|1.3||||||Serogroup Diphtheria||1.3|-3.3|
71802754|NCT02199691|143105165|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.1|||||TWO_SIDED|95.0|-1.2|1.9||||||Serogroup Tetanus||1.9|-1.2|
71802755|NCT02199691|143105166|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|1.8|||||TWO_SIDED|95.0|-1.8|6.3||||||HPV Type 6||6.3|-1.8|
71802756|NCT02199691|143105166|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.8|||||TWO_SIDED|95.0|-1.3|3.9||||||HPV Type 11||3.9|-1.3|
71802757|NCT02199691|143105166|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 16||3.6|-1.9|
71802758|NCT02199691|143105166|NON_INFERIORITY|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference between the 2 percentages was \>-10%.|Percentage Difference|0.4|||||TWO_SIDED|95.0|-1.9|3.6||||||HPV Type 18||3.6|-1.9|
71802759|NCT03403634|143105187|SUPERIORITY|||||||0.046||||||significance level = 0.05|t-test, 1 sided|df = 11. one-sided as post treatment increases were of interest. the fold changes were log-transformed prior to inferences.||||||0.046
71802760|NCT03223298|143105216|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||3-month mean change (from pre-op) in Jaw Pain compared between the Botox group and Placebo group.||||0.80
71802761|NCT03223298|143105217|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||3-month mean Jaw Function Limitation Scale score compared between Botox group and placebo group.||||0.50
71802762|NCT03223298|143105218|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Change in MIO with Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.30
71802763|NCT03223298|143105218|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Change in MIO without Pain at 3-months post-intervention compared between Botox group and Placebo group.||||0.50
71802764|NCT03223298|143105219|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mean change at 3 months post intervention - General Health Score, compared between Botox group and Placebo group.||||0.40
71802765|NCT01782131|143105223|NON_INFERIORITY|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme. The p-Value is based on the one-sided non-inferiority test. Non-inferiority of posaconazole vs. voriconazole is established if the upper limit of the 95% confidence interval is less than 10%.|Estimated Difference in Percent|-5.3|||<|0.0001|TWO_SIDED|95.0|-11.6|1.0|||Miettinen and Nurminen|||||1.0|-11.6|<.0001
71802766|NCT01782131|143105224|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|0.3|||||TWO_SIDED|95.0|-8.2|8.8||||||||8.8|-8.2|
71802767|NCT01782131|143105225|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-2.5|||||TWO_SIDED|95.0|-9.9|4.9||||||||4.9|-9.9|
71802768|NCT01782131|143105226|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|3.1|||||TWO_SIDED|95.0|-6.9|13.1||||||||13.1|-6.9|
71802769|NCT01782131|143105227|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Estimated Difference in Percent|-3.4|||||TWO_SIDED|95.0|-13.9|7.1||||||||7.1|-13.9|
71802770|NCT01782131|143105228|OTHER|Based on Miettinen and Nurminen's method stratified by the risk for mortality/poor outcome (high risk, not high risk) and using Cochran-Mantel-Haenszel weighting scheme.|Difference in Percent|-0.6|||||TWO_SIDED|95.0|-11.2|10.1||||||||10.1|-11.2|
71802771|NCT01782131|143105229|OTHER||Survival Rate in Percent|60.7||||0.2767|TWO_SIDED|95.0|52.8|67.8||Based on Stratified Log-Rank method stratified by the risk for mortality/poor outcome (high risk, not high risk).|Kaplan-Meier|From product-limit (Kaplan-Meier) method for censored data.||Analysis of Time to All-Cause Mortality Through Day 114: Posaconazole vs. Voriconazole||67.8|52.8|0.2767
71894121|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.05||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.||||0.96
71894122|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.5||||0.96|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.||||0.96
71894123|NCT03182738|143310167|SUPERIORITY|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|2.04||||0.64|TWO_SIDED|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.||||0.64
71894124|NCT00356915|143310190|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||P-Value from a Cochran-Mantel-Haenszel test, . The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
71802772|NCT01782131|143105230|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|20.4|||||TWO_SIDED|95.0|-4.1|42.7||||||||42.7|-4.1|
71802773|NCT01782131|143105231|OTHER|Based on Miettinen and Nurminen's method.|Difference in Percent|11.3|||||TWO_SIDED|95.0|-6.9|28.6||||||||28.6|-6.9|
71802774|NCT01782131|143105232|OTHER||Difference in Percent|0.3||||0.8305|TWO_SIDED|95.0|-2.9|3.6|||Miettinen & Nurminen|||Abnormal Hepatic Laboratory Value||3.6|-2.9|0.8305
71802775|NCT01782131|143105232|OTHER||Difference in Percent|-3.6||||0.3633|TWO_SIDED|95.0|-11.3|4.2|||Miettinen & Nurminen|||CNS and Visual Disturbances||4.2|-11.3|0.3633
71802776|NCT01782131|143105232|OTHER||Difference in Percent|-2.8||||0.3724|TWO_SIDED|95.0|-9.1|3.4|||Miettinen & Nurminen|||Dermatologic Reactions||3.4|-9.1|0.3724
71802777|NCT01782131|143105232|OTHER||Difference in Percent|1.0||||0.6431|TWO_SIDED|95.0|-3.4|5.5|||Miettinen & Nurminen|||Adrenal Insufficiency or Temporal Hypotension||5.5|-3.4|0.6431
71802778|NCT01782131|143105233|OTHER|Based on Miettinen \& Nurminen|Difference in Percent|0.0|||||TWO_SIDED|95.0|-2.8|2.8||||||||2.8|-2.8|
71802779|NCT01782131|143105234|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-10.2|||||TWO_SIDED|95.0|-17.9|-2.4||||||||-2.4|-17.9|
71802780|NCT01782131|143105235|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|1.9|||||TWO_SIDED|95.0|-6.1|9.8||||||||9.8|-6.1|
71802781|NCT01782131|143105236|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-1.4|||||TWO_SIDED|95.0|-5.6|2.7||||||||2.7|-5.6|
71802782|NCT01782131|143105237|OTHER|Based on Miettinen \& Nurminen method.|Difference in Percent|-3.2|||||TWO_SIDED|95.0|-11.0|4.5||||||||4.5|-11.0|
71802783|NCT01627249|143105239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||<|0.001|TWO_SIDED|95.0|1.4|5.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||5.7|1.4|<0.001
71802784|NCT01627249|143105239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.034|TWO_SIDED|95.0|0.1|4.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||4.2|0.1|0.034
71802785|NCT01627249|143105239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.12|TWO_SIDED|95.0|-0.4|3.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs. Bevacizumab||3.2|-0.4|0.12
71802786|NCT01627249|143105240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-69.9|||<|0.001|TWO_SIDED|95.0|-91.1|-48.6|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||-48.6|-91.1|<0.001
71802787|NCT01627249|143105240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.6||||0.036|TWO_SIDED|95.0|-36.0|-1.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||-1.2|-36|0.036
71802788|NCT01627249|143105240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.2|||<|0.001|TWO_SIDED|95.0|-71.2|-31.3|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||-31.3|-71.2|<0.001
71802789|NCT01627249|143105241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.001|TWO_SIDED|95.0|2.9|10.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab||10.1|2.9|0.001
71802790|NCT01627249|143105241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.0031|TWO_SIDED|95.0|1.4|8.0|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab||8.0|1.4|0.0031
71802791|NCT01627249|143105241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.21|TWO_SIDED|95.0|-1.1|4.8|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||4.8|-1.1|0.21
71802792|NCT01627249|143105242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.69|TWO_SIDED|95.0|-1.3|2.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab||2.7|-1.3|0.69
71802793|NCT01627249|143105242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab||1.5|-2.3|0.69
71894125|NCT00356915|143310191|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. No p-value was calculated for this endpoint.|Wald's CI|0.56|||||ONE_SIDED|97.5|-4.3||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||Comparison between the 2 itraconazole groups was based on lower bound of the 97.5% confidence interval for the difference. The non-inferiority analysis was restricted to the active dosing groups.|||-4.3|
71894126|NCT00356915|143310192|NON_INFERIORITY_OR_EQUIVALENCE|The assumption was that the Complete Cure rate at week 52 was 35% for the active dosing groups, a sample size of 552 ITT subjects per active group would have had a 93% power for testing the proportion of subjects with Complete Cure. These computations assumed a non inferiority margin of 10% and a one-sided significance level of 0.025. Power computations were performed using nQuery Advisor, Version 5.0.|Mean Difference (Final Values)|10.0|||<|0.001|ONE_SIDED|97.5|-1.1||||Wald's CI|The statistical analysis used Wald's CI with Yates' continuity correction.||The test for demonstrating non-inferiority was based on a margin of 10%. Thus, non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. The non-inferiority analysis was restricted to the active dosing groups.|||-1.1|< 0.001
71802794|NCT01627249|143105242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.69|TWO_SIDED|95.0|-0.9|3.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab||3.1|-0.9|0.69
71802795|NCT01138124|143105311|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.04|||<|0.0001|TWO_SIDED|95.0|1.51|2.75|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.75|1.51|<0.0001
71802796|NCT01138124|143105311|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.82||||0.0001|TWO_SIDED|95.0|1.34|2.46|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.46|1.34|0.0001
71802797|NCT01138124|143105311|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.52||||0.0627|TWO_SIDED|95.0|0.98|2.36|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.36|0.98|0.0627
71802798|NCT01138124|143105311|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.2183|TWO_SIDED|95.0|0.85|2.08|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.85|0.2183
71802799|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.82|||<|0.0001|TWO_SIDED|95.0|1.86|4.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.28|1.86|<0.0001
71802800|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.53|||<|0.0001|TWO_SIDED|95.0|1.66|3.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy"|||3.85|1.66|<0.0001
71802801|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.001|TWO_SIDED|95.0|1.51|5.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.03|1.51|0.001
71802802|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.44||||0.0042|TWO_SIDED|95.0|1.32|4.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.49|1.32|0.0042
71802803|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.8||||0.0645|TWO_SIDED|95.0|0.97|3.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.36|0.97|0.0645
71802804|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1232|TWO_SIDED|95.0|0.87|3.11|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.11|0.87|0.1232
71802805|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.55||||0.316|TWO_SIDED|95.0|0.17|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.78|0.17|0.3160
71802806|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.48||||0.2234|TWO_SIDED|95.0|0.15|1.57|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||1.57|0.15|0.2234
71802807|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3071|TWO_SIDED|95.0|0.76|2.42|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.42|0.76|0.3071
71802808|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.17||||0.6062|TWO_SIDED|95.0|0.65|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.11|0.65|0.6062
71802809|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.31||||0.5205|TWO_SIDED|95.0|0.58|2.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.97|0.58|0.5205
71802810|NCT01138124|143105312|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.11||||0.8042|TWO_SIDED|95.0|0.48|2.57|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.57|0.48|0.8042
71802811|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.15|||<|0.0001|TWO_SIDED|95.0|2.04|4.86|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.86|2.04|<0.0001
71802812|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.88|||<|0.0001|TWO_SIDED|95.0|1.85|4.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.46|1.85|<0.0001
71802813|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.75||||0.0015|TWO_SIDED|95.0|1.47|5.13|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.13|1.47|0.0015
71802814|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.45||||0.0053|TWO_SIDED|95.0|1.31|4.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.62|1.31|0.0053
71802815|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.68||||0.0777|TWO_SIDED|95.0|0.94|2.99|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.99|0.94|0.0777
71802816|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.5||||0.1762|TWO_SIDED|95.0|0.83|2.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.69|0.83|0.1762
71802817|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.82||||0.699|TWO_SIDED|95.0|0.29|2.28|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.28|0.29|0.6990
71802818|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.72||||0.5274|TWO_SIDED|95.0|0.26|2.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.01|0.26|0.5274
71802819|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3245|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3245
71802820|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6388|TWO_SIDED|95.0|0.64|2.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.07|0.64|0.6388
71802821|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.11||||0.796|TWO_SIDED|95.0|0.49|2.51|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.51|0.49|0.796
71802822|NCT01138124|143105313|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.94||||0.8772|TWO_SIDED|95.0|0.41|2.15|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.15|0.41|0.8772
71802823|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.9|||<|0.0001|TWO_SIDED|95.0|1.88|4.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.47|1.88|<0.0001
71802824|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.65|||<|0.0001|TWO_SIDED|95.0|1.71|4.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||4.11|1.71|<0.0001
71802825|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.19||||0.0212|TWO_SIDED|95.0|1.12|4.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||4.25|1.12|0.0212
71802826|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.95||||0.0522|TWO_SIDED|95.0|0.99|3.81|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||3.81|0.99|0.0522
71802827|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.87||||0.0337|TWO_SIDED|95.0|1.05|3.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.32|1.05|0.0337
71802828|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.64||||0.0947|TWO_SIDED|95.0|0.92|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.95|0.92|0.0947
71802829|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.42||||0.3928|TWO_SIDED|95.0|0.64|3.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.16|0.64|0.3928
71802830|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.21||||0.6502|TWO_SIDED|95.0|0.54|2.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.72|0.54|0.6502
71802831|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.34||||0.3275|TWO_SIDED|95.0|0.75|2.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.39|0.75|0.3275
71802832|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.6365|TWO_SIDED|95.0|0.64|2.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.08|0.64|0.6365
71802833|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.01||||0.9858|TWO_SIDED|95.0|0.42|2.41|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.42|0.9858
71802834|NCT01138124|143105314|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.87||||0.7671|TWO_SIDED|95.0|0.36|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy."|||2.12|0.36|0.7671
71802835|NCT01138124|143105315|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.79||||0.0031|TWO_SIDED|95.0|1.22|2.63|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.63|1.22|0.0031
71802836|NCT01138124|143105315|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.68||||0.0095|TWO_SIDED|95.0|1.13|2.49|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.49|1.13|0.0095
71802837|NCT01138124|143105315|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.65||||0.097|TWO_SIDED|95.0|0.91|2.99|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||2.99|0.91|0.0970
71802838|NCT01138124|143105315|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.1123|TWO_SIDED|95.0|0.89|2.97|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.97|0.89|0.1123
71894127|NCT00356915|143310193|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.||||<0.001
71894128|NCT00509106|143310200|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.|Risk Difference (RD)|5.9|||||TWO_SIDED|95.0|-1.0|12.7|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.||12.7|-1.0|
71894129|NCT00488631|143310231|SUPERIORITY_OR_OTHER|||||||0.01||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.010
71894130|NCT00488631|143310231|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.||||<0.001
71894131|NCT00488631|143310232|SUPERIORITY_OR_OTHER|||||||0.122||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.122
71894132|NCT00488631|143310232|SUPERIORITY_OR_OTHER|||||||0.004||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.004
71894133|NCT00488631|143310233|SUPERIORITY_OR_OTHER|||||||0.011||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.011
71894134|NCT00488631|143310233|SUPERIORITY_OR_OTHER|||||||0.002||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.002
71802839|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.53||||0.0012|TWO_SIDED|95.0|1.44|4.44|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)"|||4.44|1.44|0.0012
71802840|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0034|TWO_SIDED|95.0|1.32|4.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.14|1.32|0.0034
71802841|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.18||||0.0856|TWO_SIDED|95.0|0.9|5.32|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.32|0.9|0.0856
71802842|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.0996|TWO_SIDED|95.0|0.87|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|0.87|0.0996
71802843|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0563|TWO_SIDED|95.0|0.98|3.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.63|0.98|0.0563
71802844|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0896|TWO_SIDED|95.0|0.92|3.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.43|0.92|0.0896
71802845|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.4||||0.5308|TWO_SIDED|95.0|0.49|4.01|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.01|0.49|0.5308
71802846|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.39||||0.5458|TWO_SIDED|95.0|0.48|4.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.02|0.48|0.5458
71802847|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.87||||0.7744|TWO_SIDED|95.0|0.35|2.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.19|0.35|0.7744
71841170|NCT03916185|143191133|SUPERIORITY|||||||0.12||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.12
71841171|NCT03916185|143191133|SUPERIORITY|||||||0.033||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.033
71841172|NCT03916185|143191134|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71802848|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.83||||0.6999|TWO_SIDED|95.0|0.33|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.11|0.33|0.6999
71802849|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.32||||0.6528|TWO_SIDED|95.0|0.39|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.47|0.39|0.6528
71802850|NCT01138124|143105316|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.3||||0.6722|TWO_SIDED|95.0|0.38|4.47|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.47|0.38|0.6722
71841173|NCT03916185|143191134|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71841174|NCT03916185|143191134|SUPERIORITY||||||<|0.001||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||<0.001
71802851|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|3.24|||<|0.0001|TWO_SIDED|95.0|1.79|5.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||5.85|1.79|<0.0001
71802852|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.9||||0.0005|TWO_SIDED|95.0|1.59|5.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.28|1.59|0.0005
71802853|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.54||||0.042|TWO_SIDED|95.0|1.03|6.25|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.25|1.03|0.042
71802854|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.4||||0.0603|TWO_SIDED|95.0|0.96|5.98|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.98|0.96|0.0603
71802855|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.65|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.65|0.69|0.3762
71841175|NCT03916185|143191134|SUPERIORITY|||||||0.39||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.39
71841176|NCT03916185|143191134|SUPERIORITY|||||||0.15||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.15
71841177|NCT03916185|143191134|SUPERIORITY|||||||0.049||||||Statistical significance level of 0.05 was used. No adjustments made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.049
71841178|NCT05312008|143191147|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|paired||||||<0.6
71841179|NCT05312008|143191148|SUPERIORITY||||||<|0.6|||||||t-test, 2 sided|Paired||||||<0.6
71841180|NCT05312008|143191149|SUPERIORITY||||||<|1|||||||t-test, 2 sided|Paired||||||<1
71841181|NCT05312008|143191150|SUPERIORITY||||||<|0.04|||||||t-test, 2 sided|Paired||||||<0.04
71841182|NCT05312008|143191151|SUPERIORITY||||||<|0.5|||||||t-test, 2 sided|Paired||||||<0.5
71841183|NCT02844465|143191156|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 5 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Boston Naming Test score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-BNT - BSL-BNT) + δ ≤ 0 Alternate Hypothesis: μ (V-BNT - BSL-BNT) + δ \> 0 Where μ (V-BNT - BSL-BNT) = mean difference in the Boston Naming Test score from baseline to Month 12 post Visualase."||||<0.0001
71841184|NCT02844465|143191157|NON_INFERIORITY|A non-inferiority test will be performed using a paired t-test, with a non-inferiority delta (δ) of one Reliable Change Index (RCI) of 15 points, to test the hypothesis of no reduction. A two-tailed alpha of 0.05 will be used.|||||<|0.0001|||||||Paired t-test|||"It is hypothesized that the Rey Auditory Verbal Learning Test 5-Trial Total score will not decrease from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ ≤ 0 Alternate Hypothesis: μ (V-RAVLT - BSL-RAVLT) + δ \> 0 Where μ (V-RAVLT - BSL-RAVLT) = mean difference in the Rey Auditory Verbal Learning Test 5-Trial Total score from baseline to Month 12 post Visualase."||||<0.0001
71841185|NCT02844465|143191158|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It is hypothesized that the QOLIE-31 score will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) ≤ 0 Alternate Hypothesis: M (V-QOLIE-31 - BSL-QOLIE-31) \> 0 Where M (V-QOLIE-31 - BSL-QOLIE-31) = sign-test statistic (\[increases-decreases\]/2) in the Quality of Life in Epilepsy inventory from baseline to Month 12 post Visualase."||||<0.0001
71802856|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.33||||0.4073|TWO_SIDED|95.0|0.68|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.63|0.68|0.4073
71802857|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.95||||0.9294|TWO_SIDED|95.0|0.29|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.12|0.29|0.9294
71802858|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.99||||0.9875|TWO_SIDED|95.0|0.3|3.29|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.29|0.3|0.9875
71802859|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.19||||0.66|TWO_SIDED|95.0|0.54|2.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.54|0.66
71896329|NCT03114969|143314793|SUPERIORITY||Odds Ratio (OR)|3.25||||0.166|TWO_SIDED|95.0|0.612|17.244||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.244|0.612|0.166
71802860|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.1||||0.811|TWO_SIDED|95.0|0.5|2.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.45|0.5|0.8110
71802861|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.7||||0.3336|TWO_SIDED|95.0|0.58|4.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.96|0.58|0.3336
71802862|NCT01138124|143105317|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.63||||0.3782|TWO_SIDED|95.0|0.55|4.84|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.84|0.55|0.3782
71802863|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.89||||0.0841|TWO_SIDED|95.0|0.92|3.88|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.88|0.92|0.0841
71802864|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.75||||0.1313|TWO_SIDED|95.0|0.85|3.63|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.63|0.85|0.1313
71802865|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.03||||0.1488|TWO_SIDED|95.0|0.78|5.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.34|0.78|0.1488
71802866|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.05||||0.1495|TWO_SIDED|95.0|0.77|5.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||5.46|0.77|0.1495
71802867|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|2.44||||0.0013|TWO_SIDED|95.0|1.42|4.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.22|1.42|0.0013
71802868|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.34||||0.0026|TWO_SIDED|95.0|1.35|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.07|1.35|0.0026
71802869|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.78||||0.2421|TWO_SIDED|95.0|0.68|4.69|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.69|0.68|0.2421
71802870|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.7||||0.2899|TWO_SIDED|95.0|0.64|4.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||4.53|0.64|0.2899
71802871|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.99||||0.9723|TWO_SIDED|95.0|0.42|2.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.29|0.42|0.9723
71802872|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.91||||0.8206|TWO_SIDED|95.0|0.39|2.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||2.13|0.39|0.8206
71802873|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.8135|TWO_SIDED|95.0|0.35|3.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.82|0.35|0.8135
71802874|NCT01138124|143105318|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.15||||0.8173|TWO_SIDED|95.0|0.34|3.86|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy."|||3.86|0.34|0.8173
71802875|NCT01722331|143105329|SUPERIORITY||Difference in percentages|56.6|||<|0.001|TWO_SIDED|95.0|49.6|62.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||62.8|49.6|<0.001
71802876|NCT01722331|143105329|SUPERIORITY||Difference in percentages|58.0|||<|0.001|TWO_SIDED|95.0|51.0|64.1|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||64.1|51.0|<0.001
71802877|NCT01722331|143105330|SUPERIORITY||Difference in percentages|52.1|||<|0.001|TWO_SIDED|95.0|44.8|58.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||58.5|44.8|<0.001
71802878|NCT01722331|143105330|SUPERIORITY||Difference in percentages|50.9|||<|0.001|TWO_SIDED|95.0|43.6|57.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||57.4|43.6|<0.001
71894135|NCT00488631|143310234|SUPERIORITY_OR_OTHER|||||||0.365||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.365
71894136|NCT00488631|143310234|SUPERIORITY_OR_OTHER|||||||0.098||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.||||0.098
71802879|NCT01722331|143105334|SUPERIORITY||Difference in percentages|32.9|||<|0.001|TWO_SIDED|95.0|26.8|38.8|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.8|26.8|<0.001
71802880|NCT01722331|143105334|SUPERIORITY||Difference in percentages|32.1|||<|0.001|TWO_SIDED|95.0|25.9|38.0|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||38.0|25.9|<0.001
71802881|NCT01722331|143105335|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.2|8.3|<0.001
71802882|NCT01722331|143105335|SUPERIORITY||Difference in percentages|12.7|||<|0.001|TWO_SIDED|95.0|8.0|17.3|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||17.3|8.0|<0.001
71802883|NCT01722331|143105337|OTHER||Difference in least squares means|-7.7|||<|0.001|TWO_SIDED|95.0|-8.6|-6.8|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.8|-8.6|<0.001
71802884|NCT01722331|143105337|OTHER||Difference in least squares means|-7.4|||<|0.001|TWO_SIDED|95.0|-8.3|-6.5|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (\<=90 kg, \>90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).||||-6.5|-8.3|<0.001
71802885|NCT01722331|143105338|OTHER||Difference in percentages|38.9|||<|0.001|TWO_SIDED|95.0|31.9|45.4|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||45.4|31.9|<0.001
71802886|NCT01722331|143105338|OTHER||Difference in percentages|36.1|||<|0.001|TWO_SIDED|95.0|29.3|42.5|||Cochran-Mantel-Haenszel|Stratified by body weight (\<=90kg, \>90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.||||42.5|29.3|<0.001
71802887|NCT00262834|143105340|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.42
71802888|NCT00262834|143105341|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.||||||0.50
71802889|NCT00262834|143105342|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71802890|NCT00466193|143105350|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for treatment|ANCOVA|||||||<0.001
71802891|NCT00466193|143105352|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for treatment|ANCOVA|||||||0.006
71802892|NCT00466193|143105355|SUPERIORITY_OR_OTHER|||||||0.0041||95.0||||P-value is for treatment|ANCOVA|||||||0.0041
71802893|NCT01075074|143105406|SUPERIORITY_OR_OTHER|||||||0.006||||||Corrected for 6 comparisons.|Kruskal-Wallis|||A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.||||0.006
71802894|NCT01075074|143105406|SUPERIORITY_OR_OTHER||Median Difference (Net)|16.0||||0.03|TWO_SIDED|95.0|1.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|1|0.03
71802895|NCT01075074|143105406|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0||||0.01|TWO_SIDED|95.0|2.0|31.0|||Wilcoxon (Mann-Whitney)|||||31|2|0.01
71802896|NCT01075074|143105406|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||1|TWO_SIDED|95.0|-16.0|12.0|||Wilcoxon (Mann-Whitney)|||||12|-16|1.0
71802897|NCT01075074|143105407|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||P values is corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
71802898|NCT01075074|143105407|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Corrected for 6 comparisons|Kruskal-Wallis|||||||0.0003
71802899|NCT01075074|143105407|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0004|TWO_SIDED|95.0|98.0|300.0|||Wilcoxon (Mann-Whitney)|||||300|98|0.0004
71802900|NCT01075074|143105407|SUPERIORITY_OR_OTHER||Median Difference (Net)|195.0||||0.0003|TWO_SIDED|95.0|98.0|278.0|||Wilcoxon (Mann-Whitney)|||||278|98|0.0003
71802901|NCT01075074|143105407|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.86|TWO_SIDED|95.0|-105.0|83.0|||Wilcoxon (Mann-Whitney)|||||83|-105|0.86
71802902|NCT01075074|143105408|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.0005
71802903|NCT01075074|143105408|SUPERIORITY_OR_OTHER||Median Difference (Net)|38.0||||0.01|TWO_SIDED|95.0|8.0|50.0|||Wilcoxon (Mann-Whitney)|||||50|8|0.01
71802904|NCT01075074|143105408|SUPERIORITY_OR_OTHER||Median Difference (Net)|40.0||||0.003|TWO_SIDED|95.0|12.0|47.0|||Wilcoxon (Mann-Whitney)|||||47|12|0.003
71841186|NCT02844465|143191159|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.||||||0.0004|||||||Sign test|||"It is hypothesized that the SF-36 Mental Component Score (MCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) ≤ 0 Alternate Hypothesis: M (V-SF-36 - BSL-SF-36-MCS) \> 0 Where M (V- SF-36-MCS - BSL- SF-36-MCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire MCS from baseline to Month 12 post Visualase."||||0.0004
71802905|NCT01075074|143105408|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.95|TWO_SIDED|95.0|-18.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|-18|0.95
71841187|NCT02844465|143191160|OTHER|A sign test will be used to determine if the median categorical change is significantly greater than zero.|||||<|0.0001|||||||Sign test|||"It's hypothesized that the SF-36 Physical Component Score (PCS) will increase (improve) from baseline to 12 months following the Visualase procedure. The hypotheses associated with this endpoint are as follows:~Null Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) ≤ 0 Alternate Hypothesis: M (V-SF-36-PCS - BSL-SF-36-PCS) \> 0 Where M (V-SF-36-PCS - BSL- SF-36-PCS) = sign-test statistic (\[increases-decreases\]/2) in the SF-36 quality of life questionnaire PCS from baseline to Month 12 post Visualase."||||<0.0001
71841188|NCT02844465|143191161|NON_INFERIORITY|"The hypotheses associated with this endpoint are:~Null Hypothesis: π V - 64% + δ ≤ 0 Alternate Hypothesis: π V - 64% + δ \> 0 Where πV is the proportion of subjects treated with Visualase experiencing no seizures.~An exact 95% CI for the percentage of subjects who are seizure free will be calculated and its lower boundary compared to zero after subtraction of the historical open surgical resection percentage of 64% and the addition of the equivalence delta percentage of 10%."|Proportion of Participants|56.0|||||TWO_SIDED|95.0|46.2|65.8||||||||65.8|46.2|
71841189|NCT04228042|143191164|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71841190|NCT04228042|143191164|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71841191|NCT04228042|143191164|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71841192|NCT04228042|143191164|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71841193|NCT03819153|143191165|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0001|TWO_SIDED|95.0|0.66|0.88|||Regression, Cox|||Time from randomization to first composite renal event was analyzed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by use of sodium glucose cotransporter-2 (SGLT-2) inhibitor (yes/no) at baseline. Based on the available number of events for analysis, the nominal significance level was updated to 0.01612 using the Lan-DeMets alpha spending function. eGFR was calculated using the CKD-EPI formula.||0.88|0.66|0.0001
71841194|NCT03738852|143191206|SUPERIORITY|||||||0.907|||||||ANOVA|||||||0.907
71841195|NCT05452460|143191291|SUPERIORITY||Mean Difference (Final Values)|0.11|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in RT as the outcome, with Group as the factor, and pre-test condition difference in RT as the covariate.||||||> 0.05
71841196|NCT05452460|143191292|SUPERIORITY||Mean Difference (Final Values)|0.18|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in ACC the outcome, with Group as the factor, and pre-test condition difference in ACC as the covariate.||||||> .05
71841197|NCT05452460|143191293|SUPERIORITY||Mean Difference (Final Values)|0.32|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in N2 the outcome, with Group as the factor, and pre-test condition difference in N2 as the covariate.||||||> 0.05
71802906|NCT01075074|143105409|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis|||||||0.03
71841198|NCT05452460|143191294|SUPERIORITY||Mean Difference (Final Values)|0.71|||>|0.05|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in P3 the outcome, with Group as the factor, and pre-test condition difference in P3 as the covariate.||||||> 0.05
71841199|NCT05452460|143191295|SUPERIORITY||Mean Difference (Final Values)|13.35|||<|0.01|TWO_SIDED||||||ANCOVA|ANCOVA with post-test condition difference in TTE the outcome, with Group as the factor, and pre-test condition difference in TTE as the covariate.|\[F(1, 52) = 13.35, p = .001, ηp2 = .211\]|||||< 0.01
71841200|NCT05452460|143191296|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in VO2max Covariate: Pre-test condition difference in VO2max||||||> 0.05
71841201|NCT05452460|143191297|SUPERIORITY||Mean Difference (Final Values)|38.76|||<|0.01|TWO_SIDED||||||ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 3 (ASSESSMENT TIME) × 2 (Experiment Phase)||||||< 0.01
71841202|NCT05452460|143191298|SUPERIORITY||Mean Difference (Final Values)|9.21|||<|0.01|TWO_SIDED|||||The main effect of the Stroop block on accuracy showed a decrease from the first block to the fifth block.|ANOVA|Four-way mixed-design ANOVA: 2 (GROUP) × 2 (CONDITION) × 5 (BLOCK) × 2 (Phase)||||||< 0.01
71841203|NCT05452460|143191299|SUPERIORITY||Mean Difference (Final Values)|7.07|||<|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test mean score Covariate: Pre-test mean score||||||< 0.05
71841204|NCT05452460|143191300|SUPERIORITY||Mean Difference (Final Values)|1.37|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed anger Covariate: Pre-test condition difference in changed anger||||||> 0.05
71802907|NCT01075074|143105409|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.01|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.01
71841205|NCT05452460|143191301|SUPERIORITY||Mean Difference (Final Values)|2.73|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
71841206|NCT05452460|143191302|SUPERIORITY||Mean Difference (Final Values)|0.07|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed depression Covariate: Pre-test condition difference in changed depression||||||> 0.05
71802908|NCT01075074|143105409|SUPERIORITY_OR_OTHER||Median Difference (Net)|30.0||||0.04|TWO_SIDED|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)|||||60|0|0.04
71802909|NCT01075074|143105409|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.92|TWO_SIDED|95.0|-30.0|30.0|||Wilcoxon (Mann-Whitney)|||||30|-30|0.92
71802910|NCT00844194|143105451|SUPERIORITY_OR_OTHER||LSmean|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.89|-1.1|||ANCOVA|with last observation carried forward (LOCF)||||-1.10|-1.89|< 0.0001
71802911|NCT00844194|143105451|SUPERIORITY_OR_OTHER||LSmean|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.3|-1.04|||ANCOVA|||||-1.04|-2.30|< 0.0001
71802912|NCT00701389|143105550|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.|Difference in Least Squares Means|1.5|||||TWO_SIDED|90.0|0.0|3.0|||Mixed Effect Model|||100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo||3.0|0.0|
71802913|NCT00701389|143105551|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.2|||||TWO_SIDED|90.0|-0.2|2.7|||Mixed Effect Model|||sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo||2.7|-0.2|
71802914|NCT00618657|143105589|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
71802915|NCT00618657|143105589|OTHER||Standard Error|0.03|||||TWO_SIDED|||||||||||||
71802916|NCT01762761|143105593|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|26.08|||<|0.001|TWO_SIDED|95.0|7.29|93.26|||Regression, Logistic|||||93.26|7.29|<0.001
71802917|NCT01762761|143105594|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.8|||<|0.001|TWO_SIDED|95.0|8.54|66.33|||Regression, Logistic|||||66.33|8.54|<0.001
71802918|NCT01762761|143105595|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.52|||<|0.001|TWO_SIDED|95.0|3.84|18.94|||Regression, Logistic|||||18.94|3.84|<0.001
71802919|NCT01762761|143105596|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.001|TWO_SIDED|95.0|0.13|0.59|||Mixed Models Analysis|||||0.59|0.13|0.001
71802920|NCT01762761|143105597|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59||||0.306|TWO_SIDED|95.0|0.21|1.64|||Mixed Models Analysis|||||1.64|0.21|0.306
71802921|NCT01762761|143105598|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.12|||<|0.001|TWO_SIDED|95.0|4.01|9.34|||Log Rank|||||9.34|4.01|<0.001
71802922|NCT01762761|143105599|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.13|||<|0.001|TWO_SIDED|95.0|0.05|0.37|||Regression, Logistic|||||0.37|0.05|<0.001
71802923|NCT01762761|143105600|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|16.54||||0.008|TWO_SIDED|95.0|2.09|131.12|||Regression, Logistic|||||131.12|2.09|0.008
71841207|NCT05452460|143191303|SUPERIORITY||Mean Difference (Final Values)|0.2|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed fatigue Covariate: Pre-test condition difference in changed fatigue||||||> 0.05
71841208|NCT05452460|143191304|SUPERIORITY||Mean Difference (Final Values)|0.01|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
71841209|NCT05452460|143191305|SUPERIORITY||Mean Difference (Final Values)|0.66|||>|0.05|TWO_SIDED||||||ANCOVA|Factor: Group Outcome: Post-test condition difference in changed confusion Covariate: Pre-test condition difference in changed confusion||||||> 0.05
71841210|NCT01208662|143191317|SUPERIORITY||Hazard Ratio (HR)|1.53|||<|0.001|TWO_SIDED|95.0|1.23|1.91|||Log Rank|Observed Stratified Log Rank Test (1-sided p-value)||||1.91|1.23|<0.001
71841211|NCT01208662|143191318|SUPERIORITY|||||||0.55|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.55
71802924|NCT01762761|143105601|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
71802925|NCT01762761|143105602|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||van Elteren stratified rank test|||||||<0.001
71802926|NCT01381172|143105631|OTHER|The primary analysis employed a Bayesian repeated measures linear model to estimate group differences in mean pVO2 at 24 weeks from baseline, with 30% borrowing of information (70% down-weighting) from the corresponding treatment group difference observed in the FIX-5 study subgroup. The Bayesian posterior probability would need to be \> 0.975 to be considered a positive result with statistical significance.||||||0.975||||||The posterior probability (Pr) that the mean difference in pVO2 (Δ3) between device and control groups is greater than zero must exceed 0.975 to meet the primary effectiveness endpoint.|Bayesian posterior probability|||The FIX-HF-5C Study was a study designed to confirm the preliminary evidence reported in the FIX-HF-5 subgroup analysis demonstrating improvement in subjects with LVEF 25-45% and NYHA class III-IV. A Bayesian statistical approach was employed to leverage the data available, particularly the pVO2 results, from the FIX-HF-5 subgroup.||||0.975
71802927|NCT00575588|143105654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
71802928|NCT00575588|143105655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.2|||<|0.0001|TWO_SIDED|95.0|-38.1|-28.5||Between group comparison significant after controlling overall alpha of the study|Fisher Exact|||||-28.5|-38.1|<0.0001
71802929|NCT00575588|143105656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001||95.0|-2.7|-1.7||Between group comparison significant after controlling overall alpha of the study|ANCOVA|||||-1.7|-2.7|<0.0001
71802930|NCT00575588|143105657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.04|TWO_SIDED|95.0|-0.0046|-0.0001||Between group comparison significant after controlling overall alpha of the study|Mixed Models Analysis|||||-0.0001|-0.0046|0.040
71802931|NCT00575588|143105658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.06|||Repeated Measures|||||0.06|-0.17|
71802932|NCT00575588|143105659|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.9|||||TWO_SIDED|95.0|-39.8|-30.0||||||||-30.0|-39.8|
71802933|NCT00575588|143105660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|95.0|-3.32|-2.2|||Repeated Measures|||||-2.20|-3.32|
71802934|NCT00575588|143105661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0035|STANDARD_ERROR_OF_MEAN|0.0007|||TWO_SIDED|95.0|-0.0048|-0.0022|||Mixed Models Analysis|||||-0.0022|-0.0048|
71802935|NCT01854827|143105664|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
71802936|NCT01854827|143105665|SUPERIORITY|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was \> 80%.|Percent of patients|79.3|||||ONE_SIDED|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was \< 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.||63.2|
71802937|NCT01854827|143105666|OTHER|Percents with serious AEs prior to liver transplant were calculated, along with one-sided 90% Clopper-Pearson confidence interval lower bounds.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
71802938|NCT01854827|143105667|OTHER|Percent of patients with level 3-5 toxicity are presented along with one-sided 90% Clopper-Pearson confidence interval lower bound.|Percent of patients|89.7|||||ONE_SIDED|90.0|75.4||||||||||75.4|
71802939|NCT01854827|143105668|OTHER|Percent of patients with other expected AEs are presented along with one-sided 90% Clopper-Pearson confidence limit lower bound.|Percent of patients|27.6|||||ONE_SIDED|90.0|14.5||||||||||14.5|
71802940|NCT01854827|143105669|SUPERIORITY|One-sided testing for superiority of IVIG to historical control.|Odds Ratio (OR)|0.67||||0.5486|ONE_SIDED|90.0||2.38|||Regression, Logistic|||IVIG was compared to the historical placebo control from the START study (n=64): PMID: 24794368 NCT00294684||2.38||0.5486
71802941|NCT01854827|143105670|SUPERIORITY|One-sided testing for superiority of IVIG relative to historical control.|Odds Ratio (OR)|0.33||||0.8455|ONE_SIDED|90.0||1.22|||Regression, Logistic|||IVIG was compared for superiority to the historical control of START study placebo (N=64). PMID: 24794368 NCT00294684||1.22||0.8455
71802942|NCT01854827|143105671|SUPERIORITY|One-sided.|Odds Ratio (OR)|0.29||||0.8431|ONE_SIDED|90.0||1.24||One-sided|Regression, Logistic|||IVIG was compared for superiority to the historical START placebo control (N=64).||1.24||0.8431
71802943|NCT01854827|143105672|SUPERIORITY|One-sided for IVIG superior to historical START placebo control. PMID: 24794368 NCT00294684|Risk Difference (RD)|-11.9|||||ONE_SIDED|90.0||2.1||||||K-M estimates for survival for IVIG vs the historical START placebo control are provided, along with one-sided 90% upper bounds of the confidence intervals.||2.1||
71802944|NCT02571452|143105674|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.53||0.021|TWO_SIDED|95.0|-6.65|-0.55||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-0.55|-6.65|.021
71802945|NCT02571452|143105675|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.57||0.568|TWO_SIDED|95.0|-1.26|2.3||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||2.30|-1.26|.568
71802946|NCT02571452|143105676|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|0.89|<|0.001|TWO_SIDED|95.0|-5.87|-2.33||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||-2.33|-5.87|<.001
71802947|NCT02571452|143105677|SUPERIORITY||Mean Difference (Net)|-0.66|STANDARD_ERROR_OF_MEAN|0.49||0.173|TWO_SIDED|95.0|-1.61|0.29||The threshold for statistical significance was p=.05.|Mixed Models Analysis|||||0.29|-1.61|.173
71802948|NCT02660944|143105693|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|0.37||||0.845|TWO_SIDED|95.0|-3.42|4.15|||t-test, 2 sided|||Change from baseline at Day 85 RSLV-132 versus placebo||4.15|-3.42|0.845
71802949|NCT02660944|143105693|SUPERIORITY|Two-sample t-test with Satterthwaite approximation|Mean Difference (Final Values)|-0.48||||0.818|TWO_SIDED|95.0|-4.66|3.7|||t-test, 2 sided|||Change from baseline at Day 169 RSLV-132 versus placebo||3.70|-4.66|0.818
71802950|NCT04796610|143105697|SUPERIORITY||Odds Ratio (OR)|0.55||||0.49|TWO_SIDED|95.0|0.1|2.98|||Regression, Logistic|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||2.98|.1|0.49
71802951|NCT04796610|143105698|SUPERIORITY||Odds Ratio (OR)|16.82||||0.011|TWO_SIDED|95.0|1.93|146.91||Model is adjusted for participant age|Regression, Logistic||Results are presented for an indicator where 0=control and 1=intervention|||146.91|1.93|.011
71802952|NCT04796610|143105699|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.03|TWO_SIDED|95.0|0.07|0.97|||Regression, Linear|Model is adjusted for participant age|Results are presented for an indicator where 0=control and 1=intervention|||0.97|0.07|.03
71802953|NCT02059148|143105700|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.24|||||TWO_SIDED|90.0|1.11|1.38||||||||1.38|1.11|
71802954|NCT02059148|143105701|SUPERIORITY_OR_OTHER||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.05|1.23||||||||1.23|1.05|
71802955|NCT02059148|143105702|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.95||||0.0006|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|1.00|0.0006
71802956|NCT00403546|143105719|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.09|1.12|||Mixed Models Analysis|||At Baseline||1.12|-1.09|0.980
71802957|NCT00403546|143105719|SUPERIORITY||Mean Difference (Net)|1.02||||0.033|TWO_SIDED|95.0|0.08|1.95|||Mixed Models Analysis|||At Week 2||1.95|0.08|0.033
71802958|NCT00403546|143105719|SUPERIORITY||Mean Difference (Net)|0.73||||0.171|TWO_SIDED|95.0|-0.32|1.77|||Mixed Models Analysis|||At Week 4||1.77|-0.32|0.171
71802959|NCT00403546|143105719|SUPERIORITY||Mean Difference (Net)|0.5||||0.38|TWO_SIDED|95.0|-0.62|1.62|||Mixed Models Analysis|||At Week 6||1.62|-0.62|0.380
71802960|NCT00403546|143105719|SUPERIORITY||Mean Difference (Net)|-0.12||||0.84|TWO_SIDED|95.0|-1.32|1.08|||Mixed Models Analysis|||At Week 8||1.08|-1.32|0.840
71802961|NCT00403546|143105720|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.737|TWO_SIDED|95.0|-1.23|0.88|||Mixed Models Analysis|||At Baseline||0.88|-1.23|0.737
71802962|NCT00403546|143105720|SUPERIORITY||Mean Difference (Net)|-0.14||||0.764|TWO_SIDED|95.0|-1.09|0.8|||Mixed Models Analysis|||At Week 2||0.80|-1.09|0.764
71802963|NCT00403546|143105720|SUPERIORITY||Mean Difference (Net)|0.25||||0.642|TWO_SIDED|95.0|-0.82|1.32|||Mixed Models Analysis|||At Week 4||1.32|-0.82|0.642
71802964|NCT00403546|143105720|SUPERIORITY||Mean Difference (Net)|-0.34||||0.57|TWO_SIDED|95.0|-1.5|0.83|||Mixed Models Analysis|||At Week 6||0.83|-1.50|0.570
71802965|NCT00403546|143105720|SUPERIORITY||Mean Difference (Net)|-0.09||||0.894|TWO_SIDED|95.0|-1.34|1.17|||Mixed Models Analysis|||At Week 8||1.17|-1.34|0.894
71802966|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|-1.82||||0.599|TWO_SIDED|95.0|-8.68|5.05|||Mixed Models Analysis|||SBP at Baseline||5.05|-8.68|0.599
71802967|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|3.53||||0.235|TWO_SIDED|95.0|-2.31|9.37|||Mixed Models Analysis|||SBP at Week 1||9.37|-2.31|0.235
71802968|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|2.83||||0.449|TWO_SIDED|95.0|-3.8|8.57|||Mixed Models Analysis|||SBP at Week 2||8.57|-3.80|0.449
71802969|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|3.64||||0.301|TWO_SIDED|95.0|-3.28|10.56|||Mixed Models Analysis|||SBP at Week 4||10.56|-3.28|0.301
71802970|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|-0.75||||0.842|TWO_SIDED|95.0|-8.13|6.63|||Mixed Models Analysis|||SBP at Week 6||6.63|-8.13|0.842
71802971|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|6.33||||0.109|TWO_SIDED|95.0|-1.43|14.09|||Mixed Models Analysis|||SBP at Week 8||14.09|-1.43|0.109
71802972|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|-0.8||||0.741|TWO_SIDED|95.0|-5.62|4.02|||Mixed Models Analysis|||DBP at Baseline||4.02|-5.62|0.741
71802973|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|1.44||||0.552|TWO_SIDED|95.0|-3.32|6.19|||Mixed Models Analysis|||DBP at Week 1||6.19|-3.32|0.552
71802974|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|2.83||||0.268|TWO_SIDED|95.0|-2.18|7.84|||Mixed Models Analysis|||DBP at Week 2||7.84|-2.18|0.268
71894137|NCT00488631|143310235|SUPERIORITY_OR_OTHER|||||||0.279||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.279
71894138|NCT00488631|143310235|SUPERIORITY_OR_OTHER|||||||0.423||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.||||0.423
71841212|NCT01208662|143191319|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
71841213|NCT01208662|143191320|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||||0.99
71841214|NCT01208662|143191322|SUPERIORITY||Hazard Ratio (HR)|1.66|||<|0.001|TWO_SIDED|99.29|1.21|2.27|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||2.27|1.21|<0.001
71841215|NCT01208662|143191323|SUPERIORITY||Hazard Ratio (HR)|1.1|||>|0.99|TWO_SIDED|95.0|0.73|1.65|||Log Rank|||||1.65|0.73|>0.99
71841216|NCT01208662|143191325|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.99|TWO_SIDED|99.29|0.73|1.65|||Log Rank|Stratified||Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.||1.65|0.73|0.99
71841217|NCT01208662|143191332|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.3|1.01||||||||1.01|0.30|
71841218|NCT02010242|143191347|SUPERIORITY|All statistical analyses were performed on a comparison-wise basis without adjustment for multiple comparisons.||||||1|||||||ANCOVA|||Primary efficacy endpoint was analyzed using ANCOVA comparing GKT137831 vs placebo after controlling for the baseline UACR level. The UACR were log-transformed prior to analysis. The model included treatment group and log-transformed baseline UACR value as predicted variables. The results were back-transformed exponentially to calculate geo. mean values and associated 90% CIs and 1-sided p-values. The null hypothesis was that the difference in the adjusted mean logarithm of UACR was equal to 0||||1.000
71841219|NCT05764525|143191364|SUPERIORITY||Difference of least squares mean|6.938||||0.0047|TWO_SIDED|95.0|2.145|11.731|||ANOVA|||||11.731|2.145|0.0047
71841220|NCT03334630|143191367|NON_INFERIORITY|Assuming a Control composite SAE freedom rate of 93.5%, 226 subjects per group yields 80% power to detect a non-inferiority margin of -6.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.0324|||<|0.0001|TWO_SIDED|95.0|-0.0132|0.0779||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.24% = 0.0324|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.0779|-0.0132|<0.0001
71802975|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|1.02||||0.719|TWO_SIDED|95.0|-4.53|6.56|||Mixed Models Analysis|||DBP at Week 4||6.56|-4.53|0.719
71841221|NCT03334630|143191368|NON_INFERIORITY|Assuming a Control primary effectiveness rate of 65%, 229 subjects per group yields 80% power to detect a non-inferiority margin of -12.5% between treatment groups at a significance level of 0.025.|Risk Difference (RD)|0.034|||<|0.0001|TWO_SIDED|95.0|-0.042|0.109||The a priori threshold for statistical significance is 0.025.|Farrington-Manning non-inferiority test||Estimated risk difference = DiamondTemp composite SAE freedom rate - Control composite SAE freedom rate = 3.4% = 0.034|Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.||0.109|-0.042|<0.0001
71802976|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|-2.86||||0.334|TWO_SIDED|95.0|-8.68|2.96|||Mixed Models Analysis|||DBP at Week 6||2.96|-8.68|0.334
71802977|NCT00403546|143105722|SUPERIORITY||Mean Difference (Net)|4.38||||0.151|TWO_SIDED|95.0|-1.61|10.37|||Mixed Models Analysis|||DBP at Week 8||10.37|-1.61|0.151
71802978|NCT00403546|143105724|SUPERIORITY||Mean Difference (Final Values)|2.77||||0.416|TWO_SIDED|95.0|-3.97|9.5|||Mixed Models Analysis|Mixed models analysis with random slopes||At Baseline||9.50|-3.97|0.416
71802979|NCT00403546|143105724|SUPERIORITY||Mean Difference (Net)|0.37||||0.854|TWO_SIDED|95.0|-3.59|4.33|||Mixed Models Analysis|||At Week 2||4.33|-3.59|0.854
71802980|NCT00403546|143105724|SUPERIORITY||Mean Difference (Net)|1.95||||0.406|TWO_SIDED|95.0|-2.68|6.58|||Mixed Models Analysis|||At Week 4||6.58|-2.68|0.406
71802981|NCT00403546|143105724|SUPERIORITY||Mean Difference (Net)|-3.01||||0.256|TWO_SIDED|95.0|-8.23|2.21|||Mixed Models Analysis|||At Week 6||2.21|-8.23|0.256
71802982|NCT00403546|143105724|SUPERIORITY||Mean Difference (Net)|-1.37||||0.642|TWO_SIDED|95.0|-7.2|4.45|||Mixed Models Analysis|||At Week 8||4.45|-7.20|0.642
71802983|NCT00403546|143105726|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.135|TWO_SIDED|95.0|-1.55|0.2|||Mixed Models Analysis|||At Baseline||0.20|-1.55|0.135
71802984|NCT00403546|143105726|SUPERIORITY||Mean Difference (Net)|0.44||||0.262|TWO_SIDED|95.0|-0.33|1.21|||Mixed Models Analysis|||At Week 2||1.21|-0.33|0.262
71894139|NCT01873950|143310236|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
71894140|NCT01873950|143310237|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
71802985|NCT00403546|143105726|SUPERIORITY||Mean Difference (Net)|0.58||||0.209|TWO_SIDED|95.0|-0.33|1.49|||Mixed Models Analysis|||At Week 4||1.49|-0.33|0.209
71802986|NCT00403546|143105726|SUPERIORITY||Mean Difference (Net)|0.03||||0.95|TWO_SIDED|95.0|-1.01|1.07|||Mixed Models Analysis|||At Week 6||1.07|-1.01|0.950
71802987|NCT00403546|143105726|SUPERIORITY||Mean Difference (Net)|0.57||||0.34|TWO_SIDED|95.0|-0.61|1.76|||Mixed Models Analysis|||At Week 8||1.76|-0.61|0.340
71802988|NCT02673697|143105735|NON_INFERIORITY|"The primary analysis will calculate the Bayesian posterior probability that the difference \[MACCECONTROL~\- MACCEPERCEVAL\] is lower than 0.05 (predetermined non-inferiority margin): The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis."||||||0.9914||||||The null hypothesis will be rejected, and non-inferiority concluded, if the posterior probability exceeds 0.9775 at the final analysis.|Bayesian|||"A the primary analysis will compare Perceval valve (Treatment arm) vs. standard sutured stented valve (Control arm) on the Per Protocol population.~A one-sided non-inferiority test, using the non-inferiority margin Δ=0.05, will be performed to compare the two arms on the proportion of subjects that are event-free at one year (primary analysis)."||||0.9914
71802989|NCT03893448|143105747|OTHER||Percentage Point Difference|-4.8|||=|0.039|TWO_SIDED|95.0|-9.3|-0.2|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-9.3|= 0.039
71802990|NCT03893448|143105747|OTHER||Percentage Point Difference|-0.4|||=|0.836|TWO_SIDED|95.0|-4.6|3.7|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||3.7|-4.6|= 0.836
71802991|NCT03893448|143105747|OTHER||Percentage Point Difference|2.9|||=|0.235|TWO_SIDED|95.0|-1.9|7.6|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||7.6|-1.9|= 0.235
71802992|NCT03893448|143105747|OTHER||Percentage Point Difference|2.4|||=|0.26|TWO_SIDED|95.0|-1.7|6.5|||Miettinen & Nurminen||V114-Prevnar 13™|Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||6.5|-1.7|= 0.260
71802993|NCT03893448|143105748|OTHER||Percentage Point Difference|-1.8|||=|0.446|TWO_SIDED|95.0|-6.3|2.8|||Miettinen & Nurminen||V114-Prevnar 13™|Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.8|-6.3|= 0.446
71802994|NCT03893448|143105748|OTHER||Percentage Point Difference|1.0|||=|0.622|TWO_SIDED|95.0|-3.0|5.1|||Miettinen & Nurminen||V114-Prevnar 13™|Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||5.1|-3.0|= 0.622
71802995|NCT03893448|143105748|OTHER||Percentage Point Difference|-3.0|||=|0.202|TWO_SIDED|95.0|-7.6|1.6|||Miettinen & Nurminen||V114-Prevnar 13™|Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-7.6|= 0.202
71802996|NCT03893448|143105748|OTHER||Percentage Point Difference|0.0|||=|0.985|TWO_SIDED|95.0|-2.4|2.3|||Miettinen & Nurminen||V114-Prevnar 13™|Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.3|-2.4|= 0.985
71802997|NCT03893448|143105749|OTHER||Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4|||||V114-Prevnar 13™|Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.4|-0.4|
71802998|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.8|-5.2|< 0.001
71802999|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
71803000|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.2|||<|0.001|TWO_SIDED|95.0|-4.0|-0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.6|-4.0|< 0.001
71803001|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-4.2|-0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.2|-4.2|< 0.001
71803002|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-7.1|-3.0||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-3.0|-7.1|< 0.001
71894141|NCT01873950|143310238|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.||||||<0.05
71803003|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-6.6|-0.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.3|-6.6|< 0.001
71803004|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.9|-0.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.1|-1.9|< 0.001
71803005|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.8|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.6|-2.8|< 0.001
71803006|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.6|1.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||1.6|-1.6|< 0.001
71803007|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.6|0.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||0.7|-2.6|< 0.001
71803008|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.8|||<|0.001|TWO_SIDED|95.0|-3.2|-0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.8|-3.2|< 0.001
71803009|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-1.0|||<|0.001|TWO_SIDED|95.0|-2.1|-0.4||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-0.4|-2.1|< 0.001
71803010|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-3.2|2.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||2.7|-3.2|< 0.001
71803011|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|6.7|||<|0.001|TWO_SIDED|95.0|4.6|9.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||9.2|4.6|< 0.001
71803012|NCT03893448|143105750|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being \>-10 percentage points (1-sided p-value \<0.025).|Percentage Point Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-7.8|-1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method||-1.3|-7.8|< 0.001
71894142|NCT02039947|143310246|SUPERIORITY||Response rate|59.0|||<|0.0001|TWO_SIDED|95.0|47.3|70.4|||percent||Percent|||70.4|47.3|<.0001
71894143|NCT01772134|143310254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||<|0.001|TWO_SIDED|95.0|0.107|0.187|||Mixed Models Analysis|||||0.187|0.107|<0.001
71803013|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.64|||<|0.001|TWO_SIDED|95.0|0.59|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.59|< 0.001
71894144|NCT01772134|143310254|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.138|||<|0.001|TWO_SIDED|95.0|0.097|0.178|||Mixed Models Analysis|||||0.178|0.097|<0.001
71841222|NCT03334630|143191369|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-17.9|||<|0.0001|TWO_SIDED|95.0|-21.2|-14.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-14.6|-21.2|<0.0001
71894145|NCT01740362|143310258|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|137.26|||||TWO_SIDED|90.0|96.77|194.69||||||1 way Analysis of Variance (ANOVA) on natural log-transformed AUC(0-∞) analyzed using linear model with degrees of renal impairment(creatinine clearance\[CLcr, discrete\]) evaluated using blood samples collected at screening as fixed effect. Statistical Analysis System (SAS) mixed procedure (PROC MIXED) was used. Anti-log of adjusted mean difference (CP-690,550\[mild renal insufficiency\] - CP-690,550\[normal renal function\]), 90% confidence interval (CI) were taken to estimate mean ratio and 90% CI.||194.69|96.77|
71803014|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
71803015|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.95|||<|0.001|TWO_SIDED|95.0|0.88|1.03|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.03|0.88|< 0.001
71803016|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.72|||<|0.001|TWO_SIDED|95.0|0.66|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.66|< 0.001
71803017|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.52|||=|0.167|TWO_SIDED|95.0|0.48|0.58|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.58|0.48|= 0.167
71803018|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.71|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.71|< 0.001
71803019|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.71|< 0.001
71803020|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.91|||<|0.001|TWO_SIDED|95.0|0.84|1.0|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.00|0.84|< 0.001
71803021|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.78|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.78|0.63|< 0.001
71803022|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.76|||<|0.001|TWO_SIDED|95.0|0.7|0.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.83|0.70|< 0.001
71803023|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.71|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
71803024|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.69|0.79|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.79|0.69|< 0.001
71803025|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.89|||<|0.001|TWO_SIDED|95.0|0.8|0.99|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.99|0.80|< 0.001
71803026|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|3.64|||<|0.001|TWO_SIDED|95.0|3.33|3.98|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||3.98|3.33|< 0.001
71803027|NCT03893448|143105751|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.24|||<|0.001|TWO_SIDED|95.0|1.1|1.39|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.39|1.10|< 0.001
71803028|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.66|||<|0.001|TWO_SIDED|95.0|0.62|0.72|||t-test, 1 sided||V114/Prevnar 13™|Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.72|0.62|< 0.001
71803029|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
71803030|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.77|||<|0.001|TWO_SIDED|95.0|0.71|0.84|||t-test, 1 sided||V114/Prevnar 13™|Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.84|0.71|< 0.001
71841223|NCT03334630|143191370|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-11.9|||<|0.0001|TWO_SIDED|95.0|-13.9|-9.8||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||-9.8|-13.9|<0.0001
71894146|NCT01740362|143310258|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|142.59|||||TWO_SIDED|90.0|100.53|202.24||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||202.24|100.53|
71803031|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.63|||<|0.001|TWO_SIDED|95.0|0.58|0.69|||t-test, 1 sided||V114/Prevnar 13™|Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.69|0.58|< 0.001
71803032|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.6|||<|0.001|TWO_SIDED|95.0|0.54|0.65|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.65|0.54|< 0.001
71803033|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.81|||t-test, 1 sided||V114/Prevnar 13™|Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.81|0.67|< 0.001
71803034|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.77|||t-test, 1 sided||V114/Prevnar 13™|Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.77|0.65|< 0.001
71803035|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.67|< 0.001
71803036|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.81|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||t-test, 1 sided||V114/Prevnar 13™|Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.89|0.73|< 0.001
71803037|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.85|||<|0.001|TWO_SIDED|95.0|0.78|0.93|||t-test, 1 sided||V114/Prevnar 13™|Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.93|0.78|< 0.001
71803038|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.74|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.80|0.68|< 0.001
71803039|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.79|||<|0.001|TWO_SIDED|95.0|0.74|0.86|||t-test, 1 sided||V114/Prevnar 13™|Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.86|0.74|< 0.001
71803040|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.61|||<|0.001|TWO_SIDED|95.0|0.56|0.68|||t-test, 1 sided||V114/Prevnar 13™|Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||0.68|0.56|< 0.001
71803041|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|4.69|||<|0.001|TWO_SIDED|95.0|4.3|5.11|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||5.11|4.30|< 0.001
71803042|NCT03893448|143105752|NON_INFERIORITY|A conclusion of non-inferiority of V114 to Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.5 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|2.59|||<|0.001|TWO_SIDED|95.0|2.36|2.83|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||2.83|2.36|< 0.001
71803043|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.7|||<|0.001|TWO_SIDED|95.0|-2.6|1.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.1|-2.6|< 0.001
71803044|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.2|||<|0.001|TWO_SIDED|95.0|-0.4|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.4|< 0.001
71841224|NCT03334630|143191379|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-5.7|||||TWO_SIDED|95.0|-14.4|3.1||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.||Since the previous secondary endpoint (Total fluoroscopy time) was non-significant, testing stopped and this secondary endpoint was not tested.|Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||3.1|-14.4|
71894147|NCT01740362|143310258|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|222.71|||||TWO_SIDED|90.0|157.02|315.89||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||315.89|157.02|
71803045|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.7|1.9||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.9|-0.7|< 0.001
71803046|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-0.3|||<|0.001|TWO_SIDED|95.0|-1.3|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-1.3|< 0.001
71803047|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|2.0|||<|0.001|TWO_SIDED|95.0|-3.1|7.1||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||7.1|-3.1|< 0.001
71803048|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|1.8|||<|0.001|TWO_SIDED|95.0|-3.2|6.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||6.8|-3.2|< 0.001
71803049|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.8||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.8|-0.7|< 0.001
71803050|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
71803051|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.6|0.6||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.6|-0.6|< 0.001
71894148|NCT01740362|143310259|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|93.15|||||TWO_SIDED|90.0|67.22|129.06||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[mild renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||129.06|67.22|
71803052|NCT03893448|143105753|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.5|-4.3|< 0.001
71803053|NCT03893448|143105754|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.89|< 0.001
71803054|NCT03893448|143105754|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|0.98|||<|0.001|TWO_SIDED|95.0|0.87|1.09|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.09|0.87|< 0.001
71894149|NCT01740362|143310259|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|104.17|||||TWO_SIDED|90.0|75.18|144.34||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[moderate renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||144.34|75.18|
71803055|NCT03893448|143105754|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.28|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.28|0.91|< 0.001
71894150|NCT01740362|143310259|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|117.65|||||TWO_SIDED|95.0|84.91|163.02||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 \[severe renal insufficiency\] - CP-690,550 \[normal renal function\]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.||163.02|84.91|
71803056|NCT03893448|143105754|NON_INFERIORITY|A conclusion of non-inferiority of Pentacel™ administered concomitantly with V114 to Pentacel™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the GMC ratio (V114/Prevnar 13™) being \>0.67 (1-sided p-value \<0.025).|GMC Ratio (V114 / Prevnar 13™)|1.0|||<|0.001|TWO_SIDED|95.0|0.84|1.19|||t-test, 1 sided||V114/Prevnar 13™|Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.19|0.84|< 0.001
71803057|NCT03893448|143105755|NON_INFERIORITY|A conclusion of non-inferiority of VAQTA™ administered concomitantly with V114 to VAQTA™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-1.6|2.2||p value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||2.2|-1.6|< 0.001
71803058|NCT03893448|143105756|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.2|||<|0.001|TWO_SIDED|95.0|-1.8|1.3||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||1.3|-1.8|< 0.001
71803059|NCT03893448|143105756|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-3.8|0.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.2|-3.8|< 0.001
71894151|NCT04246047|143310312|SUPERIORITY||Hazard Ratio (HR)|0.41|||<|1e-05||95.0|0.31|0.53|||one-sided stratified log-rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy, prior bortezomib and revised international staging system (R-ISS) at screening, with a covariate of treatment.|||0.53|0.31|<0.00001
71894152|NCT05139030|143310359|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Difference (Final Values)|-65.8|STANDARD_ERROR_OF_MEAN|26.97||0.0074|TWO_SIDED|95.0|-118.7|-12.9|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||-12.9|-118.7|0.0074
71894153|NCT05139030|143310360|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL admix and bupivacaine HCI|Mean Ratio|0.77||||0.0018|TWO_SIDED|95.0|0.64|0.92|||ANCOVA|Total opioid consumption was transformed to log scale. Main effect of treatment, covariates: pooled Investigator site (categorical); age (continuous)||The superiority of EXPAREL admixed to bupivacaine HCI was evaluated using the Efficacy Analysis Set.||0.92|0.64|0.0018
71894154|NCT05139030|143310361|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0127|TWO_SIDED|95.0|0.51|0.96|||Cox proportional hazards model|Cox proportional hazard model: treatment as main effect, pooled Investigator site as categorical, and age and height as continuous covariates||||0.96|0.51|0.0127
71894155|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.3674|TWO_SIDED|95.0|-0.6|0.4||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.4|-0.6|0.3674
71894156|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1016|TWO_SIDED|95.0|-0.9|0.2||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-0.9|0.1016
71803060|NCT03893448|143105756|NON_INFERIORITY|A conclusion of non-inferiority of M-M-R™ II administered concomitantly with V114 to M-M-R™ II administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -5% (1-sided p-value \<0.025).|Percentage Point Difference|-0.9|||<|0.001|TWO_SIDED|95.0|-2.3|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-2.3|< 0.001
71803061|NCT03893448|143105757|NON_INFERIORITY|A conclusion of non-inferiority of VARIVAX™ administered concomitantly with V114 to VARIVAX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-3.2|0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||0.5|-3.2|< 0.001
71803062|NCT03893448|143105758|NON_INFERIORITY|A conclusion of non-inferiority of HIBERIX™ administered concomitantly with V114 to HIBERIX™ administered concomitantly with Prevnar 13™ is based on the lower bound of the 2-sided 95% CI for the difference in percentages (V114 - Prevnar 13™) being greater than -10% (1-sided p-value \<0.025).|Percentage Point Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-2.2|-0.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||-0.5|-2.2|< 0.001
71803063|NCT03893448|143105759|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|92.03|||<|0.001|TWO_SIDED|95.0|83.47|101.47|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||101.47|83.47|< 0.001
71803064|NCT03893448|143105759|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|29.5|||<|0.001|TWO_SIDED|95.0|26.16|33.26|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||33.26|26.16|< 0.001
71803065|NCT03893448|143105760|SUPERIORITY||Percentage Point Difference|95.1|||<|0.001|TWO_SIDED|95.0|93.1|96.5||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||96.5|93.1|< 0.001
71803066|NCT03893448|143105760|SUPERIORITY||Percentage Point Difference|85.2|||<|0.001|TWO_SIDED|95.0|82.3|87.7||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.||87.7|82.3|< 0.001
71803067|NCT03893448|143105761|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|68.8|||<|0.001|TWO_SIDED|95.0|63.1|75.02|||t-test, 1 sided||V114/Prevnar 13™|Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||75.02|63.10|< 0.001
71803068|NCT03893448|143105761|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|44.91|||<|0.001|TWO_SIDED|95.0|41.04|49.14|||t-test, 1 sided||V114/Prevnar 13™|Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||49.14|41.04|< 0.001
71803069|NCT03893448|143105764|SUPERIORITY||Percentage Point Difference|15.6|||<|0.001|TWO_SIDED|95.0|12.1|19.2||p-value is 1-sided|Miettinen & Nurminen||V114-Prevnar 13™|Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method||19.2|12.1|< 0.001
71803070|NCT03893448|143105765|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.73|||<|0.001|TWO_SIDED|95.0|1.61|1.87|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.87|1.61|< 0.001
71803071|NCT03893448|143105766|SUPERIORITY||GMC Ratio (V114 / Prevnar 13™)|1.35|||<|0.001|TWO_SIDED|95.0|1.25|1.46|||t-test, 1 sided||V114/Prevnar 13™|GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.||1.46|1.25|< 0.001
71803072|NCT04666441|143105801|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0004|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.25|-0.88|0.0004
71803073|NCT04666441|143105801|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-0.99|-0.34|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.34|-0.99|<0.0001
71803074|NCT04666441|143105801|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.89|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.89|0.0007
71803075|NCT04666441|143105801|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.05|-0.38|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.38|-1.05|<0.0001
71803076|NCT04666441|143105801|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0006||95.0|-0.88|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.88|0.0006
71803077|NCT04666441|143105801|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007||95.0|-0.87|-0.24|||ANCOVA|||Difference vs. Placebo (log10 copies/mL)||-0.24|-0.87|0.0007
71803078|NCT04666441|143105802|SUPERIORITY||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.72|-0.23|||ANCOVA|||||-0.23|-0.72|0.0002
71803079|NCT04666441|143105802|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.82|-0.32|||ANCOVA|||||-0.32|-0.82|<0.0001
71803080|NCT04666441|143105802|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-0.83|-0.33|||ANCOVA|||||-0.33|-0.83|<0.0001
71803081|NCT04666441|143105802|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0002||95.0|-0.75|-0.24|||ANCOVA|||||-0.24|-0.75|0.0002
71803082|NCT04666441|143105802|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.004||95.0|-0.62|-0.12|||ANCOVA|||||-0.12|-0.62|0.0040
71803083|NCT04666441|143105802|SUPERIORITY||Difference of LS Means|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0007||95.0|-0.67|-0.18|||ANCOVA|||||-0.18|-0.67|0.0007
71803084|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.82|<0.0001
71803085|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.90|<0.0001
71803086|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.42|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.97|<0.0001
71803087|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.19|-0.58|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.58|-1.19|<0.0001
71803088|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.84|-0.33|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.84|<0.0001
71803089|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.95|-0.43|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.95|<0.0001
71803090|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.98|<0.0001
71803091|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.64|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.64|-1.25|<0.0001
71803092|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.87|-0.37|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.37|-0.87|<0.0001
71803093|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.67|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.93|-0.42|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.42|-0.93|<0.0001
71803094|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.99|-0.44|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.44|-0.99|<0.0001
71803095|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.93|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.25|-0.61|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.61|-1.25|<0.0001
71803096|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.8|-0.31|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.80|<0.0001
71803097|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.38|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.38|-0.89|<0.0001
71803098|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.97|-0.43|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.43|-0.97|<0.0001
71803099|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.15|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.15|<0.0001
71803100|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.76|-0.27|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.76|<0.0001
71803101|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.83|<0.0001
71803102|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.82|-0.28|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.82|<0.0001
71803103|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.95|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.95|<0.0001
71803104|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.73|-0.23|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.73|0.0002
71803105|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.31|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.31|-0.82|<0.0001
71803106|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.33|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.33|-0.87|<0.0001
71803107|NCT04666441|143105803|SUPERIORITY||Difference of LS Means|-0.84|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.16|-0.52|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.52|-1.16|<0.0001
71803108|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.12||0.0005|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.18|-0.64|0.0005
71803109|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|<0.0001
71803110|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.75|-0.26|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.26|-0.75|<0.0001
71803111|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.88|-0.32|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.32|-0.88|<0.0001
71803112|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.12||0.0003|TWO_SIDED|95.0|-0.69|-0.21|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.21|-0.69|0.0003
71803113|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.77|-0.29|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.77|<0.0001
71803114|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.53|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.78|-0.29|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.78|<0.0001
71803115|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.98|-0.41|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.41|-0.98|<0.0001
71803116|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.72|-0.25|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.25|-0.72|<0.0001
71803117|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.74|-0.28|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.28|-0.74|<0.0001
71803118|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.3|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.30|-0.79|<0.0001
71803119|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.4|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.40|-0.99|<0.0001
71803120|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0009|TWO_SIDED|95.0|-0.63|-0.16|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.63|0.0009
71803121|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.69|-0.23|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.23|-0.69|0.0001
71803122|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.77|-0.27|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.27|-0.77|<0.0001
71803123|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.34|-0.92|<0.0001
71803124|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.0046|TWO_SIDED|95.0|-0.57|-0.1|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.10|-0.57|0.0046
71803125|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.15|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.15|-0.62|0.0011
71803126|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0029|TWO_SIDED|95.0|-0.62|-0.13|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.13|-0.62|0.0029
71803127|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.012|TWO_SIDED|95.0|-0.66|-0.08|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.08|-0.66|0.0120
71803128|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.12||0.0062|TWO_SIDED|95.0|-0.56|-0.09|||ANCOVA|||Baseline Viral Load \>10\^4 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.09|-0.56|0.0062
71803129|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.62|-0.16|||ANCOVA|||Baseline Viral Load \>10\^5 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.16|-0.62|0.0011
71803130|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.13||0.0011|TWO_SIDED|95.0|-0.66|-0.17|||ANCOVA|||Baseline Viral Load \>10\^6 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.17|-0.66|0.0011
71841225|NCT03334630|143191384|SUPERIORITY|"Four secondary endpoints will be tested for superiority over Control hierarchically with pre-specified order:~1. Mean duration of individual RF ablations (seconds)~2. Mean cumulative RF time per procedure (minutes)~3. Total fluoroscopy time (minutes)~4. Total procedure time (minutes) The first secondary endpoint needs to be significant at the two-sided 0.05 alpha level before the next one can be tested at the same threshold. Testing stops once an endpoint is determined to be non-significant."|Mean Difference (Final Values)|-0.2||||0.8528|TWO_SIDED|95.0|-1.9|1.6||The a priori threshold for statistical significance is 0.05 two-sided. The p-value is adjusted for multiple comparisons via the hierarchical testing approach.|t-test, 2 sided||Difference is DiamondTemp minus Control. A lower value is better.|"Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different."||1.6|-1.9|0.8528
71841226|NCT05907174|143191425|SUPERIORITY||B|-2.23||||0.023|TWO_SIDED||||||Regression, Linear|||||||0.023
71841227|NCT05093842|143191444|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71803131|NCT04666441|143105804|SUPERIORITY||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.29|||ANCOVA|||Baseline Viral Load \>10\^7 copies/mL Difference vs. Placebo (log10 copies/mL)||-0.29|-0.87|0.0001
71803132|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.007||95.0|-0.85|-0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.14|-0.85|0.0070
71841228|NCT05093842|143191445|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71841229|NCT05093842|143191446|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71841230|NCT05093842|143191447|OTHER|Descriptive rates were calculated.|||||||||||||||||Descriptive statistics only|||
71841231|NCT05093842|143191448|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
71841232|NCT05093842|143191449|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
71841233|NCT05093842|143191450|OTHER|Descriptive statistics only|||||||||||||||||Descriptive statistics only|||
71894157|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.34||0.0215|TWO_SIDED|95.0|-1.4|0.0||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.4|0.0215
71803133|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.69|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.06|-0.33|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.33|-1.06|0.0002
71803134|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.19||0.0008||95.0|-1.0|-0.26|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.26|-1.00|0.0008
71803135|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.19||0.0125||95.0|-0.85|-0.1|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.10|-0.85|0.0125
71803136|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0696||95.0|-0.7|0.03|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||0.03|-0.70|0.0696
71803137|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0187|TWO_SIDED|95.0|-0.79|-0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 3 (log10 copies/mL)||-0.07|-0.79|0.0187
71803138|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.96|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.39|-0.52|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.52|-1.39|<0.0001
71803139|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-1.09|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.53|-0.64|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.64|-1.53|<0.0001
71803140|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.48|-0.59|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.59|-1.48|<0.0001
71803141|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-1.05|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.5|-0.6|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.60|-1.50|<0.0001
71803142|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.34|-0.46|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.46|-1.34|<0.0001
71803143|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.92|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001||95.0|-1.35|-0.48|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 5 (log10 copies/mL)||-0.48|-1.35|<0.0001
71803144|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.22||0.0004||95.0|-1.23|-0.35|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.35|-1.23|0.0004
71803145|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0058||95.0|-1.08|-0.18|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.18|-1.08|0.0058
71803146|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.23||0.0046||95.0|-1.11|-0.2|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.20|-1.11|0.0046
71803147|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.23||0.0019||95.0|-1.18|-0.27|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.27|-1.18|0.0019
71803148|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001||95.0|-1.33|-0.44|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.44|-1.33|<0.0001
71803149|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.0079||95.0|-1.04|-0.16|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 7 (log10 copies/mL)||-0.16|-1.04|0.0079
71803150|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.45|STANDARD_ERROR_OF_MEAN|0.23||0.0515||95.0|-0.9|0.0|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.00|-0.90|0.0515
71803151|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.23||0.1864||95.0|-0.77|0.15|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.15|-0.77|0.1864
71803152|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.25|STANDARD_ERROR_OF_MEAN|0.24||0.2866||95.0|-0.72|0.21|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.21|-0.72|0.2866
71803153|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.11|STANDARD_ERROR_OF_MEAN|0.24||0.647||95.0|-0.58|0.36|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.36|-0.58|0.6470
71803154|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.028||95.0|-0.97|-0.06|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||-0.06|-0.97|0.0280
71803155|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.39|STANDARD_ERROR_OF_MEAN|0.23||0.0854||95.0|-0.84|0.05|||Mixed Models Analysis|||Difference vs. Placebo, by Day 15 (log10 copies/mL)||0.05|-0.84|0.0854
71803156|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1078|TWO_SIDED|95.0|-0.69|0.07|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.07|-0.69|0.1078
71803157|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.2235||95.0|-0.62|0.14|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.14|-0.62|0.2235
71803158|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.29|STANDARD_ERROR_OF_MEAN|0.2||0.1369||95.0|-0.68|0.09|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.09|-0.68|0.1369
71803159|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.661||95.0|-0.48|0.31|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.31|-0.48|0.6610
71803160|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.0284||95.0|-0.81|-0.05|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||-0.05|-0.81|0.0284
71803161|NCT04666441|143105808|SUPERIORITY||Difference of LS Means|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.08||95.0|-0.71|0.04|||Mixed Model for Repeated Measures (MMRM)|||Difference vs. Placebo, by Day 22 (log10 copies/mL)||0.04|-0.71|0.0800
71803162|NCT02752048|143105820|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-1.378||||0.596|TWO_SIDED|95.0|-6.757|4.0|||t-test, 2 sided|||||4.000|-6.757|0.596
71803163|NCT02752048|143105820|OTHER|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|1.349||||0.433|TWO_SIDED|95.0|-2.22|4.918|||t-test, 2 sided|||||4.918|-2.220|0.433
71803164|NCT02752048|143105821|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.484||||0.382|TWO_SIDED|95.0|-1.618|0.65|||t-test, 2 sided|||||0.650|-1.618|0.382
71803165|NCT02752048|143105821|OTHER|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.397||||0.501|TWO_SIDED|95.0|-1.61|0.817|||t-test, 2 sided|||||0.817|-1.610|0.501
71803166|NCT02752048|143105822|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.533||||0.549|TWO_SIDED|95.0|-2.363|1.298|||t-test, 2 sided|||||1.298|-2.363|0.549
71803167|NCT02752048|143105822|OTHER|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.225||||0.767|TWO_SIDED|95.0|-1.801|1.351|||t-test, 2 sided|||||1.351|-1.801|0.767
71803168|NCT01312467|143105830|SUPERIORITY_OR_OTHER||||||>|0.773|TWO_SIDED||||||A paired t-test|||||||> 0.773
71803169|NCT00132769|143105834|SUPERIORITY_OR_OTHER||Difference in LS Mean|1.48||||0.278|TWO_SIDED|95.0|-1.21|4.18|||ANCOVA|||||4.18|-1.21|0.278
71803170|NCT00132769|143105835|SUPERIORITY_OR_OTHER||Difference in Percent|-5.66||||0.543|TWO_SIDED|95.0|-24.45|13.13|||Cochran-Mantel-Haenszel|||||13.13|-24.45|0.543
71803171|NCT00132769|143105842|SUPERIORITY_OR_OTHER||LS mean ratio between treatments|0.84||||0.225|TWO_SIDED|95.0|0.63|1.12|||ANCOVA|||||1.12|0.63|0.225
71803172|NCT03047447|143105899|OTHER|||||||0.001||||||Change over time from week 0 to week 10 with HgA1c for experimental ketogenic group vs.control exercise and non-exercise groups.|ANOVA|||||||0.001
71803173|NCT03047447|143105900|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with weight for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
71803174|NCT03047447|143105901|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with BMI for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
71803175|NCT03047447|143105902|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with body fat mass for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
71803176|NCT03047447|143105903|OTHER|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with blood ketones for experimental ketogenic group vs.control exercise and non-exercise groups.||||||0.001
71803177|NCT01073618|143105950|SUPERIORITY_OR_OTHER||Efficacy rate (percent)|75.15|||||TWO_SIDED|95.0|71.36|78.94|||Normal approximation to binomial||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement||78.94|71.36|
71803178|NCT00982020|143105965|SUPERIORITY_OR_OTHER|||||||0.15||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group\*visit.||||||0.150
71803179|NCT00982020|143105966|SUPERIORITY_OR_OTHER|||||||0.52||||||The threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.||||||0.520
71841234|NCT03910478|143191451|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.948||||0.892|TWO_SIDED|95.0|0.438|2.053|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician-recommended CMV monitoring tests in the study period by 1-year after HCT.||2.053|0.438|0.8920
71841235|NCT03910478|143191452|EQUIVALENCE|A two-sided Wald-test for evidence of a non-zero coefficient for intervention group in the regression was conducted at the 5% significance level.|Odds Ratio (OR)|0.66||||0.3008|TWO_SIDED|95.0|0.301|1.45|||Regression, Logistic|The logistic regression was adjusted by covariates (transplant site and participant's perceived ease of access to blood draw facility).||A traditional logistic regression model was fit where the outcome was whether or not participants completed \> 90% of their clinician -recommended CMV monitoring tests in the study period by 1-year after HCT.||1.450|0.301|0.3008
71841236|NCT06415292|143191470|SUPERIORITY||||||<|0.001||||||The P-value reported here is the calculated p-value. The p-value theshold for significance was p =0.05|t-test, 2 sided|||||||<0.001
71841237|NCT02432261|143191513|SUPERIORITY|We did not statistically power this study.|difference of proportion of subjects|57.6||||0.003|TWO_SIDED||||||Fisher Exact||The difference of proportion = NES/Testosterone - Testosterone|||||0.003
71803180|NCT00982020|143105968|SUPERIORITY_OR_OTHER|||||||0.008||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.008
71803181|NCT00982020|143105969|SUPERIORITY_OR_OTHER|||||||0.266||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included intervention group, visit, region, and intervention group\*visit.||||||0.266
71803182|NCT00982020|143105970|SUPERIORITY_OR_OTHER|||||||0.954||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group\*visit.||||||0.954
71803183|NCT00982020|143105971|SUPERIORITY_OR_OTHER|||||||0.103||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.103
71803184|NCT00982020|143105972|SUPERIORITY_OR_OTHER|||||||0.436||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group\*visit.||||||0.436
71803185|NCT00406029|143106003|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.753|TWO_SIDED|95.0|-0.9|1.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.753
71803186|NCT00406029|143106003|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.162|TWO_SIDED|95.0|-1.7|0.3||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline at endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.162
71803187|NCT00406029|143106003|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.049|TWO_SIDED|95.0|-2.1|0.0||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-2.1|0.049
71803188|NCT00406029|143106003|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.019|TWO_SIDED|95.0|-2.2|-0.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-2.2|0.019
71803189|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.935|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.9|0.935
71803190|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.326|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.326
71803191|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.07|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.7|0.070
71803192|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.02|TWO_SIDED|95.0|-1.9|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.9|0.020
71803193|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.982|TWO_SIDED|95.0|-1.0|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.0|0.982
71803194|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.281|TWO_SIDED|95.0|-1.5|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.5|0.281
71803195|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.261|TWO_SIDED|95.0|-1.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.6|0.261
71841238|NCT04447040|143191638|SUPERIORITY||Least square (LS) Mean Difference|31.48|STANDARD_ERROR_OF_MEAN|5.379|<|0.001|TWO_SIDED|95.0|20.9|42.07|||ANOVA|||||42.07|20.90|<0.001
71841239|NCT04447040|143191638|SUPERIORITY||LS Mean Difference|41.38|STANDARD_ERROR_OF_MEAN|5.267|<|0.001|TWO_SIDED|95.0|31.02|51.75|||ANOVA|||||51.75|31.02|<0.001
71841240|NCT04447040|143191638|SUPERIORITY||LS Mean Difference|46.86|STANDARD_ERROR_OF_MEAN|5.292|<|0.001|TWO_SIDED|95.0|36.44|57.27|||ANOVA|||||57.27|36.44|<0.001
71841241|NCT04447040|143191638|SUPERIORITY||LS Mean Difference|54.04|STANDARD_ERROR_OF_MEAN|5.321|<|0.001|TWO_SIDED|95.0|43.57|64.51|||ANOVA|||||64.51|43.57|<0.001
71841242|NCT04447040|143191638|SUPERIORITY||LS Mean Difference|59.92|STANDARD_ERROR_OF_MEAN|5.468|<|0.001|TWO_SIDED|95.0|49.16|70.68|||ANOVA|||||70.68|49.16|<0.001
71803196|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.447|TWO_SIDED|95.0|-1.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.4|0.447
71803197|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.378|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.378
71803198|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.299|TWO_SIDED|95.0|-1.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.7|0.299
71803199|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.377|TWO_SIDED|95.0|-1.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.6|0.377
71803200|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.707|TWO_SIDED|95.0|-1.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-1.3|0.707
71803201|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.562|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.4|0.562
71803202|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.156|TWO_SIDED|95.0|-1.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.7|0.156
71803203|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.292|TWO_SIDED|95.0|-1.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.6|0.292
71803204|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.034|TWO_SIDED|95.0|-2.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.2|0.034
71803205|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.762|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.762
71803206|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.092|TWO_SIDED|95.0|-1.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.9|0.092
71803207|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.013|TWO_SIDED|95.0|-2.3|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.3|0.013
71803208|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005|TWO_SIDED|95.0|-2.5|-0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.4|-2.5|0.005
71803209|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.293|TWO_SIDED|95.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.293
71803210|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.095|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.0|0.095
71803211|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.04||95.0|-2.3|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-2.3|0.040
71803212|NCT00406029|143106004|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.011|TWO_SIDED|95.0|-2.5|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-2.5|0.011
71803213|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.47|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.470
71803214|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.505|TWO_SIDED|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.6|0.505
71803215|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.114|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.114
71803216|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.042|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.042
71803217|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.684|TWO_SIDED|94.0|-0.8|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.8|0.684
71803218|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.489|TWO_SIDED|95.0|-0.7|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.7|0.489
71803219|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.305|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.305
71803220|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.451|TWO_SIDED|95.0|-0.6|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.6|0.451
71841243|NCT04447040|143191639|SUPERIORITY||LS Mean Difference|35.66|STANDARD_ERROR_OF_MEAN|6.542|<|0.001|TWO_SIDED|95.0|22.79|48.54|||ANOVA|||||48.54|22.79|<0.001
71803221|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.68|TWO_SIDED|95.0|-1.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.5|0.680
71803222|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.466|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.466
71803223|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.45|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.8|0.450
71803224|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.523|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.523
71803225|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.309|TWO_SIDED|95.0|-0.6|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.6|0.309
71803226|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.136|TWO_SIDED|95.0|-0.3|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.3|0.136
71803227|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.106|TWO_SIDED|95.0|-0.2|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.2|0.106
71803228|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.144|TWO_SIDED|95.0|-0.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.3|0.144
71803229|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.954|TWO_SIDED|95.0|-1.1|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.1|0.954
71803230|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.152|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.152
71803231|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.012|TWO_SIDED|95.0|0.3|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.3|0.012
71803232|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
71803233|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.151|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.3|0.151
71803234|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.235|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.235
71803235|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.007|TWO_SIDED|95.0|0.5|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|0.5|0.007
71803236|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.033|TWO_SIDED|95.0|0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.1|0.033
71803237|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.757
71803238|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.341|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.5|0.341
71803239|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.024|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.024
71803240|NCT00406029|143106005|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.049|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.049
71803241|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.151|TWO_SIDED|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.3|0.151
71803242|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.93|TWO_SIDED|95.0|-1.1|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.1|0.930
71803243|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.343|TWO_SIDED|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.6|0.343
71803244|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.746|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.9|0.746
71803245|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.222|TWO_SIDED|94.0|-0.5|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.5|0.222
71841244|NCT04447040|143191639|SUPERIORITY||LS Mean Difference|49.04|STANDARD_ERROR_OF_MEAN|6.407|<|0.001|TWO_SIDED|95.0|36.44|61.65|||ANOVA|||||61.65|36.44|<0.001
71803246|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.673|TWO_SIDED|95.0|-1.0|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.0|0.673
71803247|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.415|TWO_SIDED|95.0|-0.7|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.7|0.415
71803248|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.968|TWO_SIDED|95.0|-1.3|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.3|0.968
71803249|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.543|TWO_SIDED|95.0|-1.0|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.0|0.543
71803250|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.967|TWO_SIDED|95.0|-1.4|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.4|0.967
71803251|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.411|TWO_SIDED|95.0|-0.8|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.8|0.411
71803252|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.864|TWO_SIDED|95.0|-1.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.6|0.864
71803253|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.449|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.449
71803254|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.411|TWO_SIDED|95.0|-2.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.0|0.411
71803255|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.576|TWO_SIDED|95.0|-1.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.0|0.576
71803256|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.603|TWO_SIDED|95.0|-1.9|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.9|0.603
71803257|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.842|TWO_SIDED|95.0|-1.4|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.4|0.842
71803258|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.558|TWO_SIDED|95.0|-1.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-1.9|0.558
71803259|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.245|TWO_SIDED|95.0|-0.6|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|-0.6|0.245
71803260|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.93|TWO_SIDED|95.0|-1.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.5|0.930
71803261|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.759|TWO_SIDED|95.0|-1.5|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.5|0.759
71803262|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.374|TWO_SIDED|95.0|-2.4|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.4|0.374
71803263|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
71803264|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.607|TWO_SIDED|95.0|-2.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-2.1|0.607
71803265|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.907|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.907
71803266|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.368|TWO_SIDED|95.0|-2.1|0.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-2.1|0.368
71803267|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.654|TWO_SIDED|95.0|-1.1|1.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.1|0.654
71803268|NCT00406029|143106006|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.769|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.769
71803269|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.055|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.055
71803270|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.071|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.0|0.071
71841245|NCT04447040|143191639|SUPERIORITY||LS Mean Difference|53.64|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|40.97|66.31|||ANOVA|||||66.31|40.97|<0.001
71803271|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.288|TWO_SIDED|95.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.288
71803272|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.764|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.764
71803273|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.342|TWO_SIDED|94.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.342
71803274|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.611|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.611
71803275|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.424|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.424
71803276|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.991|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.991
71803277|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.185|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.3|0.185
71803278|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.0|0.597
71803279|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.09|TWO_SIDED|95.0|-1.5|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.5|0.090
71803280|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.686|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.686
71803281|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.501|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.0|0.501
71803282|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.764|TWO_SIDED|95.0|-0.6|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.6|0.764
71803283|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.715|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.9|0.715
71803284|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.924|TWO_SIDED|95.0|-0.7|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.7|0.924
71803285|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.264|TWO_SIDED|95.0|-1.2|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.2|0.264
71803286|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.976|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.7|0.976
71803287|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.626|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.9|0.626
71803288|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.925|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.925
71803289|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.849|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.0|0.849
71803290|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.755|TWO_SIDED|95.0|-0.7|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.7|0.755
71803291|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.863|TWO_SIDED|95.0|-0.8|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.8|0.863
71803292|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.477|TWO_SIDED|95.0|-0.5|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.5|0.477
71803293|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.432|TWO_SIDED|95.0|-1.0|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.0|0.432
71803294|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.909|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.909
71803295|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.812|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.812
71841246|NCT04447040|143191639|SUPERIORITY||LS Mean Difference|60.93|STANDARD_ERROR_OF_MEAN|6.472|<|0.001|TWO_SIDED|95.0|48.19|73.67|||ANOVA|||||73.67|48.19|<0.001
71803296|NCT00406029|143106007|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.54|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.540
71803297|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.829|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.7|0.829
71803298|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.042|TWO_SIDED|95.0|0.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.0|0.042
71803299|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.204|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.204
71803300|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.035|TWO_SIDED|95.0|0.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|0.1|0.035
71803301|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.696|TWO_SIDED|94.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.696
71803302|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.625|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.625
71803303|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.478|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.478
71803304|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.38|TWO_SIDED|95.0|-0.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.5|0.380
71803305|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.2|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-1.2|0.925
71803306|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.285|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.285
71841247|NCT04447040|143191639|SUPERIORITY||LS Mean Difference|67.58|STANDARD_ERROR_OF_MEAN|6.65|<|0.001|TWO_SIDED|95.0|54.49|80.67|||ANOVA|||||80.67|54.49|<0.001
71841248|NCT04447040|143191640|SUPERIORITY||LS mean Difference|12.53|STANDARD_ERROR_OF_MEAN|3.097|<|0.001|TWO_SIDED|95.0|6.44|18.63|||ANOVA|||||18.63|6.44|<0.001
71841249|NCT04447040|143191640|SUPERIORITY||LS MEAN Difference|17.73|STANDARD_ERROR_OF_MEAN|3.032|<|0.001|TWO_SIDED|95.0|11.76|23.7|||ANOVA|||||23.70|11.76|<0.001
71841250|NCT04447040|143191640|SUPERIORITY||LS Mean Difference|21.88|STANDARD_ERROR_OF_MEAN|3.047|<|0.001|TWO_SIDED|95.0|15.89|27.88|||ANOVA|||||27.88|15.89|<0.001
71841251|NCT04447040|143191640|SUPERIORITY||LS Mean Difference|25.01|STANDARD_ERROR_OF_MEAN|3.063|<|0.001|TWO_SIDED|95.0|18.98|31.03|||ANOVA|||||31.03|18.98|<0.001
71841252|NCT04447040|143191640|SUPERIORITY||LS Mean Difference|29.3|STANDARD_ERROR_OF_MEAN|3.148|<|0.001|TWO_SIDED|95.0|23.11|35.5|||ANOVA|||||35.50|23.11|<0.001
71841253|NCT04447040|143191641|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
71841254|NCT04447040|143191641|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
71841255|NCT04447040|143191641|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
71841256|NCT04447040|143191641|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
71841257|NCT04447040|143191641|SUPERIORITY||||||<|0.001|||||||Wilcoxon test|||||||<0.001
71841258|NCT04447040|143191642|SUPERIORITY|||||||0.014|||||||Wald method|||||||0.014
71841259|NCT04447040|143191642|SUPERIORITY|||||||0.002|||||||Wald method|||||||0.002
71841260|NCT04447040|143191642|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
71841261|NCT04447040|143191642|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
71803307|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.296|TWO_SIDED|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.5|0.296
71803308|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.241|TWO_SIDED|95.0|-0.5|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-0.5|0.241
71841262|NCT04447040|143191642|SUPERIORITY||||||<|0.001|||||||Wald method|||||||<0.001
71841263|NCT01928394|143191686|SUPERIORITY||Odds Ratio (OR)|2.12||||0.0309|TWO_SIDED|95.0|1.06|4.26|||Cochran-Mantel-Haenszel|||SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion||4.26|1.06|0.0309
71841264|NCT04433208|143191687|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71841265|NCT02398656|143191693|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.88|1.04||||||||1.04|0.88|
71841266|NCT04299464|143191695|SUPERIORITY||Difference in Adjusted Mean|-0.432||||0.765|TWO_SIDED|80.0|-2.291|1.428|||ANCOVA|||||1.428|-2.291|0.7650
71841267|NCT04299464|143191695|SUPERIORITY||Difference in Adjusted Mean|-0.4444||||0.7517|TWO_SIDED|80.0|-2.25|1.363|||ANCOVA|||||1.363|-2.250|0.7517
71841268|NCT04299464|143191704|SUPERIORITY||Difference in Adjusted Mean|1.741||||0.6082|TWO_SIDED|80.0|-2.631|6.114|||ANCOVA|||||6.114|-2.631|0.6082
71841269|NCT04299464|143191704|SUPERIORITY||Difference in Adjusted Mean|-1.715||||0.6228|TWO_SIDED|80.0|-6.204|2.774|||ANCOVA|||||2.774|-6.204|0.6228
71841270|NCT04299464|143191705|SUPERIORITY||Difference in Adjusted Mean|-2.983||||0.1987|TWO_SIDED|80.0|-5.957|-0.009|||ANCOVA|||||-0.009|-5.957|0.1987
71841271|NCT04299464|143191705|SUPERIORITY||Difference in Adjusted Mean|-4.474||||0.046|TWO_SIDED|80.0|-7.326|-1.622|||ANCOVA|||||-1.622|-7.326|0.0460
71841272|NCT04299464|143191706|SUPERIORITY||Difference in Adjusted Means|1.279||||0.4746|TWO_SIDED|80.0|-1.021|3.578|||ANCOVA|||||3.578|-1.021|0.4746
71803309|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.571|TWO_SIDED|95.0|-0.9|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.9|0.571
71803310|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.032|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.032
71803311|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.214|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.4|0.214
71803312|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.051|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.051
71803313|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.572|TWO_SIDED|95.0|-0.9|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.9|0.572
71803314|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.041|TWO_SIDED|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.1|0.041
71803315|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.24|TWO_SIDED|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.5|0.240
71803316|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.047|TWO_SIDED|95.0|0.0|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.4|0.0|0.047
71803317|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.228|TWO_SIDED|95.0|-0.5|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.5|0.228
71803318|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.03|TWO_SIDED|95.0|0.1|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.1|0.030
71803319|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.059|TWO_SIDED|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|0.0|0.059
71803320|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.021|TWO_SIDED|95.0|0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.2|0.021
71803321|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.428|TWO_SIDED|95.0|-0.6|1.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-0.6|0.428
71803322|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.025|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|0.2|0.025
71803323|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-0.1|0.064
71803324|NCT00406029|143106008|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.047|TWO_SIDED|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|0.0|0.047
71803325|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.345|TWO_SIDED|95.0|-1.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-1.4|0.345
71803326|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.468|TWO_SIDED|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.6|0.468
71803327|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.596|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.596
71803328|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.107|TWO_SIDED|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-0.2|0.107
71803329|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.348|TWO_SIDED|94.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.8|0.348
71803330|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.938|TWO_SIDED|95.0|-1.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.1|0.938
71803331|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.897|TWO_SIDED|95.0|-1.1|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.1|0.897
71803332|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.518|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.8|0.518
71803333|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.311|TWO_SIDED|95.0|-2.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.2|0.311
71841273|NCT04299464|143191706|SUPERIORITY||Difference in Adjusted Means|2.697||||0.1244|TWO_SIDED|80.0|0.453|4.94|||ANCOVA|||||4.940|0.453|0.1244
71803334|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.597|TWO_SIDED|95.0|-1.0|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.0|0.597
71803335|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.925|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.925
71803336|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.478|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.478
71803337|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.995|TWO_SIDED|95.0|-1.5|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.5|0.995
71803338|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.057|TWO_SIDED|95.0|0.0|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|0.0|0.057
71803339|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.6||||0.431|TWO_SIDED|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-0.9|0.431
71803340|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.099|TWO_SIDED|95.0|-0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-0.2|0.099
71803341|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.847|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-1.5|0.847
71803342|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.093|TWO_SIDED|95.0|-0.2|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.2|0.093
71803343|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.471|TWO_SIDED|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-0.9|0.471
71803344|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.102|TWO_SIDED|95.0|-0.2|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|-0.2|0.102
71841274|NCT04731129|143191707|SUPERIORITY|||||||0.023||||||threshold for statistical significance \< 0.05|Fisher Exact|||Abnormal tissular architecture||||0.023
71841275|NCT04731129|143191707|SUPERIORITY|||||||0.01||||||Threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell size||||0.01
71841276|NCT04731129|143191707|SUPERIORITY|||||||0.01||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell shape||||0.01
71841277|NCT04731129|143191707|SUPERIORITY|||||||0.013||||||threshold for statistical significance \< 0.05|Fisher Exact|||Homogeneous cell fluorescence||||0.013
71841278|NCT04731129|143191707|SUPERIORITY|||||||0.16||||||threshold for statistical significance \< 0.05|Fisher Exact|||Blood vessel dysplasia||||0.16
71841279|NCT04731129|143191707|SUPERIORITY|||||||0.17||||||threshold for statistical significance \< 0.05|Fisher Exact|||Organized conjunctive fibers||||0.17
71841280|NCT04731129|143191707|SUPERIORITY|||||||0.049||||||threshold for statistical significance \< 0.05|Fisher Exact|||Full chia seed sign||||0.049
71841281|NCT04731129|143191707|SUPERIORITY|||||||0.0041||||||threshold for statistical significance \< 0.05|Fisher Exact|||General physician conclusion||||0.0041
71841282|NCT03386578|143191719|OTHER||Incidence rate ratio|1.62|||||TWO_SIDED|95.0|0.89|2.94||||||The incidence rate ratio of cumulative maternal adverse events was calculated between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and the PrEP-unexposed (Cohort 2/Step 1) reference group based on incidence per person-time follow-up. Maternal participants in Cohort 2/Step 2 contributed person-time to both Cohort 2/Step 1 and Step 2.||2.94|0.89|
71841283|NCT03386578|143191720|OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.52|1.5||||||Odds ratio comparing the proportion of mothers with adverse pregnancy outcomes between the PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group.||1.50|0.52|
71841284|NCT03386578|143191720|OTHER|||||||0.68|||||||Fisher Exact|||Test the differences in the proportion of mothers with adverse pregnancy outcomes between PrEP-exposed (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 2) groups.||||0.68
71841285|NCT03386578|143191721|OTHER||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|0.7|2.38||||||The incidence rate ratio of cumulative infant AEs between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed (Cohort 2/Step 1) reference group was based on incidence per person-time follow-up. Cohort 2/Step 2 infants contributed person-time to both Cohort 2/Step 1 and Step 2.||2.38|0.70|
71841286|NCT03386578|143191722|OTHER|||||||0.18|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant whole-body bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.18
71841287|NCT03386578|143191723|OTHER|||||||0.39|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.39
71841288|NCT03386578|143191724|OTHER|||||||0.12|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant lumbar-spine bone mineral content (WB-BMC) at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.12
71841289|NCT03386578|143191725|OTHER|||||||0.7|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.70
71841290|NCT03386578|143191726|OTHER|||||||0.58|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine levels at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.58
71803345|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.415|TWO_SIDED|95.0|-0.9|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.9|0.415
71803346|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.5||||0.051|TWO_SIDED|95.0|0.0|3.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.0|0.0|0.051
71803347|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.103|TWO_SIDED|95.0|-0.3|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-0.3|0.103
71803348|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.022|TWO_SIDED|95.0|0.3|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|0.3|0.022
71803349|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.903|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.2|0.903
71803350|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.074|TWO_SIDED|95.0|-0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-0.1|0.074
71803351|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.185|TWO_SIDED|95.0|-0.4|2.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.4|0.185
71803352|NCT00406029|143106009|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.054|TWO_SIDED|95.0|0.0|2.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.6|0.0|0.054
71803353|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.985|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.985
71803354|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.556|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.3|0.556
71803355|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.776|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.776
71803356|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.777|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.4|0.777
71803357|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.92|TWO_SIDED|94.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.5|0.920
71803358|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.155|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.1|0.155
71803359|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.843|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.843
71803360|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.673|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.673
71803361|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.612|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.612
71803362|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.512|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.4|0.512
71803363|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.269|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.269
71803364|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.516|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.516
71803365|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.597|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.8|0.597
71803366|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.766|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.7|0.766
71803367|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.428|TWO_SIDED|95.0|-0.9|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.9|0.428
71803368|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.796|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.7|0.796
71803369|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.988|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.988
71803370|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.786|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.786
71803371|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.702|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.702
71803372|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.371|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.371
71803373|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.981|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.981
71803374|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.282|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.3|0.282
71803375|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.55|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.7|0.550
71803376|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.72|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.5|0.720
71803377|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.742|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.742
71803378|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.211|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.2|0.211
71803379|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.906|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-0.6|0.906
71803380|NCT00406029|143106010|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.868|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.868
71803381|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.747|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.6|0.747
71803382|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.14|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.140
71803383|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.148|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.148
71803384|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.005|TWO_SIDED|95.0|-1.2|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-1.2|0.005
71803385|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.256|TWO_SIDED|94.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.8|0.256
71803386|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.343|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.343
71803387|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.102|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.102
71803388|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.161|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.161
71803389|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.15|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.150
71803390|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
71803391|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.013|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.013
71803392|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.12|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-0.9|0.120
71803393|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.971|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.6|0.971
71803394|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.456|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.456
71803395|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.018|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.1|-1.2|0.018
71803396|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.175|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-0.9|0.175
71803397|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.422|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-0.3|0.422
71803398|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.651|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.4|0.651
71803399|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.096|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.1|-1.0|0.096
71803400|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.86|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.5|0.860
71803401|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.511|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-0.8|0.511
71803402|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.286|TWO_SIDED|95.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.9|0.286
71803403|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.004|TWO_SIDED|95.0|-1.4|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.3|-1.4|0.004
71803404|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.06|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.060
71803405|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.345|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.8|0.345
71803406|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.439|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-0.7|0.439
71803407|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.004|TWO_SIDED|95.0|-1.4|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-1.4|0.004
71803408|NCT00406029|143106017|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.04|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-1.1|0.040
71803409|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.743|TWO_SIDED|95.0|-1.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.1|0.743
71803410|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.225|TWO_SIDED|95.0|-2.2|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.2|0.225
71803411|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.252|TWO_SIDED|95.0|-2.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.2|0.252
71803412|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.173|TWO_SIDED|95.0|-2.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-2.3|0.173
71803413|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.757|TWO_SIDED|94.0|-1.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|-1.3|0.757
71803414|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.581|TWO_SIDED|95.0|-1.1|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.1|0.581
71803415|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.195|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.195
71803416|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.272|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-2.4|0.272
71803417|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.758|TWO_SIDED|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-1.7|0.758
71803418|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.416|TWO_SIDED|95.0|-2.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-2.1|0.416
71803419|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.174|TWO_SIDED|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-2.5|0.174
71803420|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.547|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.0|-1.1|0.547
71803421|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.372|TWO_SIDED|95.0|-0.8|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-0.8|0.372
71803422|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.942|TWO_SIDED|95.0|-1.4|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.5|-1.4|0.942
71803423|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.082|TWO_SIDED|95.0|-2.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-2.8|0.082
71803424|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.267|TWO_SIDED|95.0|-2.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-2.3|0.267
71803425|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.801|TWO_SIDED|95.0|-1.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-1.5|0.801
71803426|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.753|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.753
71803427|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.087|TWO_SIDED|95.0|-3.1|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-3.1|0.087
71803428|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.796|TWO_SIDED|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.9|0.796
71803429|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.621|TWO_SIDED|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-1.3|0.621
71803430|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.784|TWO_SIDED|95.0|-1.8|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-1.8|0.784
71803431|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.024|TWO_SIDED|95.0|-3.5|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-3.5|0.024
71803432|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.963|TWO_SIDED|95.0|-1.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.6|0.963
71803433|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.331|TWO_SIDED|95.0|-0.8|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-0.8|0.331
71803434|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.898|TWO_SIDED|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-1.4|0.898
71803435|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.058|TWO_SIDED|95.0|-3.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.0|-3.0|0.058
71803436|NCT00406029|143106018|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.832|TWO_SIDED|95.0|-1.3|1.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-1.3|0.832
71803437|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.365|TWO_SIDED|95.0|-2.0|5.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.3|-2.0|0.365
71803438|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.476|TWO_SIDED|95.0|-2.4|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.4|0.476
71803439|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.343|TWO_SIDED|95.0|-2.0|5.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.6|-2.0|0.343
71803440|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.103|TWO_SIDED|95.0|-6.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-6.8|0.103
71803441|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.224|TWO_SIDED|94.0|-6.0|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.0|0.224
71803442|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.4||||0.448|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.448
71803443|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.7||||0.154|TWO_SIDED|95.0|-6.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.4|0.154
71803444|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.8||||0.01|TWO_SIDED|95.0|-8.5|-1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-1.1|-8.5|0.010
71803445|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|1.2||||0.54|TWO_SIDED|95.0|-2.6|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.6|0.540
71803446|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.646|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.7|0.646
71803447|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.608|TWO_SIDED|95.0|-4.9|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-4.9|0.608
71803448|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9||||0.343|TWO_SIDED|95.0|-6.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.1|-6.0|0.343
71803449|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|1.7||||0.419|TWO_SIDED|95.0|-2.5|5.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.9|-2.5|0.419
71803450|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|1.1||||0.562|TWO_SIDED|95.0|-2.8|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-2.8|0.562
71803451|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.525|TWO_SIDED|95.0|-5.3|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.7|-5.3|0.525
71803452|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.0||||0.148|TWO_SIDED|95.0|-7.0|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-7.0|0.148
71803453|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.3||||0.546|TWO_SIDED|95.0|-5.4|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.9|-5.4|0.546
71803454|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.7||||0.068|TWO_SIDED|95.0|-7.6|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.3|-7.6|0.068
71803455|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.5||||0.208|TWO_SIDED|95.0|-6.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-6.5|0.208
71803456|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4||||0.099|TWO_SIDED|95.0|-7.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-7.5|0.099
71803457|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8||||0.731|TWO_SIDED|95.0|-3.6|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.1|-3.6|0.731
71803458|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.861|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-4.5|0.861
71803459|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.621|TWO_SIDED|95.0|-5.2|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-5.2|0.621
71803460|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.288|TWO_SIDED|95.0|-6.4|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-6.4|0.288
71803461|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.861|TWO_SIDED|95.0|-3.5|4.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.1|-3.5|0.861
71803462|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.954|TWO_SIDED|95.0|-4.0|3.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.0|0.954
71803463|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.6||||0.419|TWO_SIDED|95.0|-5.5|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.3|-5.5|0.419
71803464|NCT00406029|143106019|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.088|TWO_SIDED|95.0|-6.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.9|0.088
71803465|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.924|TWO_SIDED|95.0|-3.5|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.2|-3.5|0.924
71803466|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.84|TWO_SIDED|95.0|-3.8|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.1|-3.8|0.840
71803467|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9||||0.599|TWO_SIDED|95.0|-4.4|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.4|0.599
71803468|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.6||||0.134|TWO_SIDED|95.0|-6.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-6.0|0.134
71803469|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.846|TWO_SIDED|94.0|-4.1|3.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.3|-4.1|0.846
71803470|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|1.3||||0.467|TWO_SIDED|95.0|-2.3|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.0|-2.3|0.467
71803471|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.533|TWO_SIDED|95.0|-4.8|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.5|-4.8|0.533
71803472|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.1||||0.094|TWO_SIDED|95.0|-6.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.5|-6.7|0.094
71803473|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.994|TWO_SIDED|95.0|-3.7|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-3.7|0.994
71803474|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.944|TWO_SIDED|95.0|-3.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.5|0.944
71803475|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.424|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.2|-5.1|0.424
71803476|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.0||||0.042|TWO_SIDED|95.0|-7.8|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||-0.2|-7.8|0.042
71803477|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|3.7||||0.075|TWO_SIDED|95.0|-0.4|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|-0.4|0.075
71803478|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|3.9||||0.052|TWO_SIDED|95.0|0.0|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||7.8|0.0|0.052
71803479|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.975|TWO_SIDED|95.0|-4.0|3.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.9|-4.0|0.975
71803480|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.2||||0.541|TWO_SIDED|95.0|-5.2|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-5.2|0.541
71803481|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.931|TWO_SIDED|95.0|-4.1|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.7|-4.1|0.931
71803482|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.618|TWO_SIDED|95.0|-4.7|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||2.8|-4.7|0.618
71803483|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.8||||0.341|TWO_SIDED|95.0|-5.6|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.9|-5.6|0.341
71803484|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2||||0.256|TWO_SIDED|95.0|-6.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-6.0|0.256
71803485|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|1.8||||0.399|TWO_SIDED|95.0|-2.4|6.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||6.0|-2.4|0.399
71803486|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|1.4||||0.477|TWO_SIDED|95.0|-2.5|5.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||5.4|-2.5|0.477
71803487|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.172|TWO_SIDED|95.0|-6.8|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-6.8|0.172
71803488|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3||||0.254|TWO_SIDED|95.0|-6.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.7|-6.2|0.254
71803489|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.972|TWO_SIDED|95.0|-3.6|3.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||3.8|-3.6|0.972
71803490|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.891|TWO_SIDED|95.0|-3.5|4.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||4.0|-3.5|0.891
71803491|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.8||||0.143|TWO_SIDED|95.0|-6.6|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-6.6|0.143
71803492|NCT00406029|143106020|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.2||||0.083|TWO_SIDED|95.0|-6.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-6.8|0.083
71803493|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.154|TWO_SIDED|95.0|-0.2|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.2|0.154
71803494|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.38|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.380
71803495|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.288|TWO_SIDED|95.0|-0.3|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.3|0.288
71803496|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.355|TWO_SIDED|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.4|0.355
71803497|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.831|TWO_SIDED|94.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.831
71803498|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.198|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.2|-1.2|0.198
71803499|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.792|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.792
71803500|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.749|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-0.8|0.749
71803501|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.896|TWO_SIDED|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-0.8|0.896
71803502|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.5|0.480
71803503|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.4||||0.285|TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.4|0.285
71803504|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.212|TWO_SIDED|95.0|-0.3|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.3|-0.3|0.212
71803505|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.883|TWO_SIDED|95.0|-0.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.9|0.883
71803506|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.0||||0.947|TWO_SIDED|95.0|-0.9|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.9|-0.9|0.947
71803507|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.1|0.663
71803508|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.7||||0.157|TWO_SIDED|95.0|-0.3|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.6|-0.3|0.157
71803509|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.5||||0.283|TWO_SIDED|95.0|-1.4|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.4|0.283
71803510|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.768|TWO_SIDED|95.0|-1.0|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.0|0.768
71803511|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.334|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.4|-1.3|0.334
71803512|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.465|TWO_SIDED|95.0|-1.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.6|-1.2|0.465
71803513|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.688|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.8|-1.2|0.688
71803514|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.9||||0.062|TWO_SIDED|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.8|0.0|0.062
71803515|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.579|TWO_SIDED|95.0|-1.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||0.7|-1.2|0.579
71803516|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.644|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.2|-0.7|0.644
71803517|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.825|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.825
71841291|NCT03386578|143191727|OTHER|||||||0.08|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.08
71841292|NCT03386578|143191728|OTHER|||||||0.52|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant creatinine clearance rate at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1)||||0.52
71841293|NCT03386578|143191729|OTHER|||||||0.3|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at birth between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.30
71841294|NCT03386578|143191730|OTHER|||||||0.06|||||||t-test, 2 sided|||A two-sample t-test was used to evaluate the difference in mean infant length-for-age z-score at week 26 between PrEP-exposed group (Cohort 1 and Cohort 2/Step 2) and PrEP-unexposed group (Cohort 2/Step 1).||||0.06
71841295|NCT03386578|143191731|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71841296|NCT04726371|143191750|SUPERIORITY|||||||0.89||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of infections over follow-up.|Test of joint null hypothesis from model|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A Poisson GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline infection incidence, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and for intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||0.89
71803518|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.5||||0.233|TWO_SIDED|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.4|-0.3|0.233
71803519|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.1||||0.853|TWO_SIDED|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.0|-0.8|0.853
71803520|NCT00406029|143106021|SUPERIORITY_OR_OTHER||Difference in LS Means|0.2||||0.592|TWO_SIDED|95.0|-0.6|1.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.||1.1|-0.6|0.592
71803521|NCT03669081|143106034|OTHER|The null hypothesis for the test was no difference between groups.||||||0.006||||||The significance level for this test was 0.05.|Wilcoxon (Mann-Whitney)|We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.||||||0.006
71803522|NCT03669081|143106035|OTHER|The null hypothesis was no difference between groups.||||||0.029|||||||Exact Wilcoxon rank sum test|||||||0.029
71814122|NCT02007434|143130442|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.39|STANDARD_ERROR_OF_MEAN|0.61||0.5206|TWO_SIDED|95.0|-0.82|1.6|||ANCOVA||Paradigm 1 - Paradigm 3|Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.60|-0.82|0.5206
71814123|NCT02007434|143130442|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.606|TWO_SIDED|395.0|-0.86|1.46|||ANCOVA||Paradigm 1 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.46|-0.86|0.6060
71814124|NCT02007434|143130442|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.7935|TWO_SIDED|95.0|-0.98|1.27|||ANCOVA||Paradigm 2 - Paradigm 3|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.27|-0.98|0.7935
71814125|NCT02007434|143130442|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|0.06|STANDARD_ERROR_OF_MEAN|0.55||0.914|TWO_SIDED|95.0|-1.03|1.15|||ANCOVA||Paradigm 2 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.15|-1.03|0.9140
71814126|NCT02007434|143130442|SUPERIORITY_OR_OTHER||LS Mean Placebo-adjusted Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.56||0.8754|TWO_SIDED|95.0|-1.21|1.04|||ANCOVA||Paradigm 3 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.||1.04|-1.21|0.8754
71814127|NCT01287611|143130453|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.0001|||||||Chi-squared|||||||0.0001
71814128|NCT01287611|143130454|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.001|||||||t-test, 2 sided|||||||0.001
71814129|NCT01856712|143130455|SUPERIORITY||Odds Ratio (OR)|1.71|||||TWO_SIDED|95.0|0.35|9.98||||||||9.98|0.35|
71894158|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.34||0.0794|TWO_SIDED|95.0|-1.2|0.2||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.2|-1.2|0.0794
71803523|NCT03669081|143106036|NON_INFERIORITY|We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.|||||<|0.0001||||||This p-value was compared to a significance threshold of 0.025.|Wilcoxon (Mann-Whitney)|||The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.||||<0.0001
71803524|NCT03669081|143106037|OTHER|The null hypothesis was no difference between groups.||||||0.002|||||||t-test, 2 sided|||||||0.002
71803525|NCT03669081|143106038|OTHER|The null hypothesis was no difference between groups.|||||>|0.99|||||||Fisher Exact|||||||>0.99
71803526|NCT00389324|143106040|NON_INFERIORITY_OR_EQUIVALENCE|The administration effect between SC and IV was assessed by exponentiation of the difference in least squares means between study phases (Test minus Reference) and the corresponding 90% confidence interval (CI) for the geometric LSM ratio between study phases (Test/Reference) for AUC. The Test (SC) was to be considered non-inferior to Reference (IV) if the lower bound of 90% CIs for the geometric LSM ratios of AUC between the Test and Reference was above 0.80 (80%).|Geometric Least Square Mean Ratio|0.888||||||90.0|0.861|0.917|||ANOVA||An adjusted steady-state area under the concentration vs. time curve following SC administration based on IV dosing schedule was calculated as AUC0-τ,SC multiplied by 3 or 4 for subjects on every-3-week or every-4-week IV dosing schedule.|The IV phase was considered as the Reference study phase and the SC phase as the Test study phase. The ANOVA included calculation of least-squares means (LSM), differences between adjusted means and the standard error associated with these differences.||0.917|0.861|
71803527|NCT04079933|143106049|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-12.6||||0.2347|TWO_SIDED|95.0|-33.5|8.27|||t-test, 2 sided||"Difference in Least Square (LS) means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||8.27|-33.5|0.2347
71803528|NCT04079933|143106049|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL|Mean Difference (Net)|-11.9||||0.2905|TWO_SIDED|95.0|-33.9|10.2|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline in urinary total NNAL||10.2|-33.9|0.2905
71803529|NCT04079933|143106050|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL|Mean Difference (Net)|-3.72||||0.9433|TWO_SIDED|95.0|-107.0|99.4|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study in urinary total NNAL||99.4|-107|0.9433
71803530|NCT04079933|143106050|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL|Mean Difference (Net)|-12.2||||0.8264|TWO_SIDED|95.0|-122.0|97.5|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in urinary total NNAL; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in urinary total NNAL||97.5|-122|0.8264
71803531|NCT04079933|143106051|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.13||||0.4903|TWO_SIDED|95.0|-4.35|2.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.10|-4.35|0.4903
71894159|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.3606|TWO_SIDED|95.0|-0.7|0.5||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.5|-0.7|0.3606
71894160|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0184|TWO_SIDED|95.0|-1.1|0.0||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.0|-1.1|0.0184
71803532|NCT04079933|143106051|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents|Mean Difference (Net)|-1.4||||0.4251|TWO_SIDED|95.0|-4.88|2.07|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in nicotine equivalents||2.07|-4.88|0.4251
71803533|NCT04079933|143106052|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-9.83||||0.406|TWO_SIDED|95.0|-33.2|13.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||13.5|-33.2|0.4060
71675284|NCT01908829|142868063|SUPERIORITY||LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.93|-0.35||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.35|-0.93|<0.001
71803534|NCT04079933|143106052|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents|Mean Difference (Net)|-10.3||||0.4165|TWO_SIDED|95.0|-35.4|14.7|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in nicotine equivalents; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in nicotine equivalents||14.7|-35.4|0.4165
71803535|NCT04079933|143106053|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|-269.0||||0.724|TWO_SIDED|95.0|-1773.0|1235.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1235|-1773|0.7240
71803536|NCT04079933|143106053|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA|Mean Difference (Net)|50.5||||0.9508|TWO_SIDED|95.0|-1566.0|1667.0|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in S-PMA||1667|-1566|0.9508
71803537|NCT04079933|143106054|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-19.0||||0.1524|TWO_SIDED|95.0|-45.1|7.12|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||7.12|-45.1|0.1524
71841297|NCT04726371|143191751|SUPERIORITY||||||>|0.99||||||A Wald test was used to test against the null hypothesis that intervention main effect and interaction effects between intervention and time trends were simultaneously zero and assess for differences in the mean trend of scores over follow-up.|Wald test|Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.||A GLMM was fit with a main effect for intervention group, linear and quadratic time trends, and interaction effects between intervention and the time trend variables. The model was adjust for stratification factors, baseline fidelity score, agency and included random intercept for group home.|"The point estimates for intervention main effect, intervention by linear time effect, and intervention by time\^2 interaction effect are described in the paper Tailored vs. General COVID-19 prevention for adults with mental disabilities residing in group homes: a randomized controlled effectiveness-implementation trial by Bartels S, Levison JH, Trieu HD, et al., published in 2024 in BMC Public Health, doi:10.1186/s12889-024-18835-w."|||>.99
71894161|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0476|TWO_SIDED|95.0|-1.1|0.1||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0476
71894162|NCT05139030|143310362|SUPERIORITY||Least square mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0529|TWO_SIDED|95.0|-1.1|0.1||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.1|-1.1|0.0529
71894163|NCT03772327|143310369|SUPERIORITY||Mean Difference (Net)|0.333||||0.07|TWO_SIDED|95.0|-0.028|0.694|||t-test, 2 sided|A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.|The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.|The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.||0.694|-0.028|0.070
71894164|NCT03772327|143310370|EQUIVALENCE|Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p \> 0.05.|Difference in proportions|0.045||||0.89|TWO_SIDED|95.0|-0.179|0.27|||Chi-squared, Corrected|degrees of freedom = 1|This is the proportion of those completing a week 12 visit less those completing a week 0 visit.|The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.||0.270|-0.179|0.89
71803538|NCT04079933|143106054|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA|Mean Difference (Net)|-12.1||||0.4014|TWO_SIDED|95.0|-40.4|16.3|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in S-PMA; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in S-PMA||16.3|-40.4|0.4014
71803539|NCT04079933|143106055|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.507||||0.0241|TWO_SIDED|95.0|-0.946|-0.0674|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||-0.0674|-0.946|0.0241
71803540|NCT04079933|143106055|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin|Mean Difference (Net)|-0.367||||0.1292|TWO_SIDED|95.0|-0.843|0.108|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in carboxyhemoglobin||0.108|-0.843|0.1292
71803541|NCT04079933|143106056|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-10.0||||0.0333|TWO_SIDED|95.0|-19.2|-0.803|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||-0.803|-19.2|0.0333
71803542|NCT04079933|143106056|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin|Mean Difference (Net)|-6.76||||0.1767|TWO_SIDED|95.0|-16.6|3.08|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in carboxyhemoglobin||3.08|-16.6|0.1767
71803543|NCT04079933|143106057|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.51||||0.2961|TWO_SIDED|95.0|-4.36|1.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||1.34|-4.36|0.2961
71803544|NCT04079933|143106057|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide|Mean Difference (Net)|-1.05||||0.5015|TWO_SIDED|95.0|-4.12|2.03|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in exhaled carbon monoxide||2.03|-4.12|0.5015
71803545|NCT04079933|143106058|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide|Mean Difference (Net)|-12.1||||0.2048|TWO_SIDED|95.0|-30.9|6.68|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in exhaled carbon monoxide||6.68|-30.9|0.2048
71803546|NCT04079933|143106058|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide|Mean Difference (Net)|-7.32||||0.4731|TWO_SIDED|95.0|-27.4|12.8|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to control in exhaled carbon monoxide; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to control in exhaled carbon monoxide||12.8|-27.4|0.4731
71803547|NCT04079933|143106059|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.86|||<|0.0001|TWO_SIDED|95.0|-5.25|-2.47|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Change from baseline = study group + visit + study group\*visit + subject +random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.47|-5.25|<0.0001
71803548|NCT04079933|143106059|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day|Mean Difference (Net)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.14|-2.34|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline in cigarettes smoked per day||-2.34|-5.14|<0.0001
71803549|NCT04079933|143106060|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.5|||<|0.0001|TWO_SIDED|95.0|-30.5|-14.5|||t-test, 2 sided||"Difference in Least Square means (Test - Control) using Mixed Effects Repeated Measures Model 1:~Percent Change from baseline = study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.5|-30.5|<0.0001
71803550|NCT04079933|143106060|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day|Mean Difference (Net)|-22.3|||<|0.0001|TWO_SIDED|95.0|-30.4|-14.1|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~%Change from baseline = study group +visit +study group\*visit +CPD +Sex +Race +BMI +Age +subject +random error, fitted with unstructured covariance matrix."|Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study in cigarettes smoked per day||-14.1|-30.4|<0.0001
71841298|NCT04726371|143191752|SUPERIORITY||Hazard Ratio (HR)|1.21|||>|0.99|TWO_SIDED|95.0|0.79|1.84||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the combined population of residents with SMI and ID/DD. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.84|0.79|>.99
71841299|NCT04726371|143191753|SUPERIORITY||Hazard Ratio (HR)|0.99|||>|0.99|TWO_SIDED|95.0|0.86|1.15||Bonferroni-adjusted p-value is reported to correct for multiplicity for testing outcomes with 6 combinations of outcomes and subpopulations.|Regression, Cox|||A Cox frailty model was fit to evaluate differences in the hazard of vaccination uptake between arms separately within the staff population. This model included a main effect for intervention arm and additionally adjusted for stratification factors, GH agency, and GH-level log-normal frailties.||1.15|0.86|>.99
71841300|NCT02724969|143191754|SUPERIORITY|||||||0.272|||||||Mixed Models Analysis|||||||.272
71841301|NCT02724969|143191755|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||.082
71841302|NCT02724969|143191756|SUPERIORITY|||||||0.355|||||||Mixed Models Analysis|||||||.355
71841303|NCT02724969|143191757|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||||||.780
71841304|NCT02724969|143191758|SUPERIORITY|||||||0.588|||||||Mixed Models Analysis|||||||.588
71841305|NCT04587453|143191897|OTHER|No formal testing was performed. Confidence intervals (CIs) are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-11.2|22.5|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Responders were considered those meeting an IGA score of 0 or 1 (clear or almost clear). Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||22.5|-11.2|
71841306|NCT04587453|143191898|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-2.9|33.0|||||Mantel-Haenzel risk difference, stratified by baseline IGA.|Subjects with 75% reduction in EASI were considered responders. Subjects with missing data or subjects who had received rescue medication prior to Week 16 were considered non-responders in the primary analysis of the primary estimand.||33.0|-2.9|
71841307|NCT04587453|143191899|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-5.1|||||TWO_SIDED|95.0|-12.4|2.3|||||Analysis of covariance (ANCOVA). Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||2.3|-12.4|
71841308|NCT04587453|143191900|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.7|0.5|||||ANCOVA. Worst observation carried forward for all subjects who prior to Week 16 had received rescue medication. Multiple imputation of missing values for subjects who had not received rescue medication.|||0.5|-2.7|
71841309|NCT04587453|143191901|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|-3.8|||||TWO_SIDED|95.0|-21.7|14.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least a reduction of 4 in the worst daily pruritus NRS score were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data at Week 16 were imputed as non-responders.||14.2|-21.7|
71841310|NCT04587453|143191902|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-3.0|33.2|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with a reduction of 90% in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||33.2|-3.0|
71841311|NCT04587453|143191903|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Risk Difference (RD)|5.7|||||TWO_SIDED|95.0|-9.0|20.3|||||Mantel-Haenszel risk difference, stratified by baseline IGA.|Subjects with at least 50% reduction in EASI were considered responders. Subjects who had received rescue medication were considered non-responders. Subjects with missing data were imputed as non-responders.||20.3|-9.0|
71841312|NCT04587453|143191904|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-14.9|6.3|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||6.3|-14.9|
71841313|NCT04587453|143191905|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.7|0.8|||||Repeated measurements Model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||0.8|-0.7|
71841314|NCT04587453|143191906|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.9|0.6|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 1 change imputed as 0 if no post-baseline assessments.|||0.6|-0.9|
71841315|NCT04587453|143191907|OTHER|No formal testing was performed. CIs are presented with two sided 95% degree of confidence.|Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.6|-0.9|||||Repeated measurements model: Change=Treatment\*Week+Baseline\*Week+Baseline IGA. Data after permanent discontinuation of IMP/initiation of rescue medication not included (4 subjects excluded). Week 2 change imputed as 0 if no post-baseline assessments.|||-0.9|-5.6|
71841316|NCT03125070|143191910|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.90
71841317|NCT03125070|143191911|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05|Chi-squared|||||||0.60
71841318|NCT03125070|143191912|OTHER|||||||0.27||||||The threshold for statistical significance was p=0.05|Chi-squared|||Sex: Female vs. Male||||0.27
71841319|NCT03125070|143191912|OTHER|||||||0.88||||||The threshold for statistical significance was p=0.05|Chi-squared|||Age \<70 vs. \>=70||||0.88
71841320|NCT03125070|143191912|OTHER|||||||0.98||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Race and ethnicity: white AND non-Hispanic versus any other combination of race and ethnicity (BIPOC)||||0.98
71841321|NCT03125070|143191912|OTHER|||||||0.19||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Education: High school or less versus at least some college or vocational/technical program||||0.19
71803551|NCT04079933|143106061|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.408||||0.0919|TWO_SIDED|95.0|-0.884|0.0673|||t-test, 2 sided||"Difference in LS mean change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0673|-0.884|0.0919
71803552|NCT04079933|143106061|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence|Mean Difference (Net)|-0.405||||0.0975|TWO_SIDED|95.0|-0.886|0.0751|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|Null hypothesis = Test and Control groups will have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence||0.0751|-0.886|0.0975
71803553|NCT04079933|143106061|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.31||||0.0643|TWO_SIDED|95.0|-17.1|0.499|||t-test, 2 sided||"Difference in LS mean percent change between study groups using Mixed Effects Repeated Measures Model 1:~Change from baseline=study group + visit + study group\*visit + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.499|-17.1|0.0643
71803554|NCT04079933|143106061|EQUIVALENCE|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"|Mean Difference (Net)|-8.84||||0.0517|TWO_SIDED|95.0|-17.7|0.0661|||t-test, 2 sided||"Difference in LS means (Test - Control) using Mixed Effects Repeated Measures Model 2:~Change from baseline= study group + visit + study group\*visit + CPD + Sex + Race + BMI + Age + subject + random error, fitted with unstructured covariance matrix"|"Statistical Analysis of Difference in Percent Change from Baseline in Total Score of Fagerstrom Test for Cigarette Dependence between the Study Groups.~Null hypothesis = Test and Control groups will have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of percent change from baseline to end of study for Fagerstrom Test score for Cigarette Dependence"||0.0661|-17.7|0.0517
71803555|NCT04079933|143106062|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.216||||0.216|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.2160
71803556|NCT04079933|143106062|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study|Probability|0.0648||||0.0648|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Null hypothesis = Test and Control groups will have equivalent levels of change in quit attempts from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quit attempts from baseline to end of study||||0.0648
71841322|NCT03125070|143191912|OTHER|||||||0.24||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Income: \<$100,000 annual versus \>=$100,000 annual||||0.24
71841323|NCT03125070|143191912|OTHER|||||||0.28||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||PHQ score at baseline: no depression (\<10), mild depression (10-14), moderate depression (15-19), severe depression (\>=20)||||0.28
71841324|NCT03125070|143191912|OTHER|||||||0.33||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer the survey items for this measure are shown as unknwon in the table and are excluded from the statistical test.||CTXD score at baseline \<0.9 (not distressed) or \>=0.9 (distressed)||||0.33
71841325|NCT03125070|143191912|OTHER|||||||0.1||||||The threshold for statistical significance was p=0.05|Chi-squared|Participants that did not answer this survey item are shown as unknwon in the table and are excluded from the statistical test.||Cardiometabolic Healthcare Utilization (HCU-C) score at baseline: \>.80 versus \<.80||||0.10
71803557|NCT04079933|143106063|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study|Probability|0.5977||||0.5977|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent levels of change in quitting intentions from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent levels of change in quitting intentions from baseline to end of study||||0.5977
71803558|NCT04079933|143106064|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL|Mean Difference (Net)|10.0||||0.4388|TWO_SIDED|95.0|-15.5|35.5|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of NNAL; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of NNAL||35.5|-15.5|0.4388
71803559|NCT04079933|143106065|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites|Mean Difference (Net)|0.45||||0.339|TWO_SIDED|95.0|-0.48|1.38|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of nicotine metabolites; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of nicotine metabolites||1.38|-0.48|0.3390
71803560|NCT04079933|143106066|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA|Mean Difference (Net)|-205.0||||0.4526|TWO_SIDED|95.0|-745.0|334.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of S-PMA; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of S-PMA||334|-745|0.4526
71803561|NCT04079933|143106067|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin|Mean Difference (Net)|0.0||||0.944|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carboxyhemoglobin; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carboxyhemoglobin||0.2|-0.2|0.9440
71803562|NCT04079933|143106068|EQUIVALENCE|Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide|Mean Difference (Net)|0.0||||0.7484|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||Null hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will have equivalent levels of change in mean exposure of carbon monoxide; Alternate hypothesis = The Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT have equivalent levels of change from baseline to end of study in mean exposure of carbon monoxide||1|-1|0.7484
71803563|NCT04079933|143106069|EQUIVALENCE|Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent|Mean Difference (Net)|0.0||||0.9992|TWO_SIDED|95.0|0.0|0.0|||t-test, 2 sided|||Null hypothesis = Cigarette consumption (CPD) determined using the Day 1 (Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will be equivalent; Alternate hypothesis = Cigarette consumption (CPD) determined using the Day 1(Weekly Recall) and Day 8 (Daily Tracking using IVRS) methods will NOT be equivalent||0|0|0.9992
71803564|NCT04079933|143106091|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.1661||||0.1661|TWO_SIDED||||||Cochran-Mantel-Haenszel||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.1661
71841326|NCT03125070|143191912|OTHER|||||||0.31||||||The threshold for statistical significance was p=0.05|Chi-squared|||Secondary cancer screening healthcare utilization (HCU-SM) at baseline: \>=.80 versus \<.80||||0.31
71841327|NCT03125070|143191913|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
71841328|NCT03125070|143191914|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
71841329|NCT02800356|143191938|OTHER|||||||0.404|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.404
71841330|NCT02800356|143191939|OTHER|||||||0.232|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.232
71841331|NCT02800356|143191940|OTHER|||||||0.001|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.001
71841332|NCT02800356|143191943|OTHER|||||||0.267|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis||||||0.267
71894165|NCT03772327|143310371|SUPERIORITY||Median Difference (Net)|-0.07||||0.328|TWO_SIDED||||||Kruskal-Wallis|Log transformation of viral load|Difference of log viral load at Week 12 less the log viral load at baseline|Null hypothesis: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.||||0.328
71894166|NCT03772327|143310372|SUPERIORITY||Odds Ratio (OR)|0.395||||0.294|TWO_SIDED|95.0|0.058|2.044|||Fisher Exact||Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA \< 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).|Null hypothesis: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA \< 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.||2.044|0.058|0.294
71894167|NCT03772327|143310374|SUPERIORITY||Difference in proportions|0.019||||1|TWO_SIDED|95.0|-0.237|0.276|||Chi-squared, Corrected|||Null hypothesis: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.||0.276|-0.237|1
71894168|NCT04233424|143310375|SUPERIORITY||Risk Ratio (RR)|-2.8||||0.152|TWO_SIDED|95.0|-6.7|1.0|||Cochran-Mantel-Haenszel|||||1.0|-6.7|0.152
71894169|NCT04233424|143310376|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.6219|TWO_SIDED|95.0|-3.9|2.3|||Cochran-Mantel-Haenszel|||||2.3|-3.9|0.6219
71894170|NCT04233424|143310377|SUPERIORITY||Risk Ratio (RR)|-0.8||||0.4373|TWO_SIDED|95.0|-2.8|1.2|||Kaplan-Meier Analysis|||||1.2|-2.8|0.4373
71894171|NCT01254344|143310380|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a 70% rate (i.e., proportion of participants with success of prophylaxis) for both groups and a significance level of 0.025, at least 200 evaluable participants per group were needed to have 90% probability that the lower limit of the 95% (two-sided) confidence interval for the difference in the response rates between the 2 groups was greater than -15 percentage points."|Difference in percentage of prophylaxis|0.1|||||TWO_SIDED|95.0|-5.2|5.5|||Miettinen and Nurminen|||||5.5|-5.2|
71894172|NCT01254344|143310381|SUPERIORITY_OR_OTHER||Difference in percentage of prophylaxis|1.3|||||TWO_SIDED|95.0|-2.2|5.1|||Miettinen and Nurminen|||||5.1|-2.2|
71894173|NCT01982630|143310395|OTHER||Difference of Least Squares Means|-0.23|||||TWO_SIDED|90.0|-4.59|4.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.13|-4.59|
71894174|NCT01982630|143310395|OTHER||Difference of Least Squares Means|-6.25|||||TWO_SIDED|90.0|-10.48|-2.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.01|-10.48|
71894175|NCT01982630|143310395|OTHER||Difference of Least Squares Means|6.02|||||TWO_SIDED|90.0|1.81|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|1.81|
71803565|NCT04079933|143106091|EQUIVALENCE|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study|Probability|0.2139||||0.2139|TWO_SIDED||||||Fisher Exact||Estimated value is the probability of observed distribution assuming the null hypothesis|Null hypothesis = Test and Control groups will have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study; Alternate hypothesis = Test and Control groups will NOT have equivalent number of subjects in subgroups based on urinary total NNAL change from baseline to end of study||||0.2139
71803566|NCT01731171|143106146|OTHER|The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.|Cox Proportional Hazard|0.37|||=|0.029|TWO_SIDED|95.0|||||Regression, Logistic||Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.|||||=.029
71803567|NCT01731171|143106147|SUPERIORITY||||||=|0.022|||||||Chi-squared|||||||=.022
71894176|NCT01982630|143310395|OTHER||Difference of Least Squares Means|1.5|||||TWO_SIDED|90.0|-2.65|5.64|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.64|-2.65|
71894177|NCT01982630|143310395|OTHER||Difference of Least Squares Means|-4.52|||||TWO_SIDED|90.0|-8.52|-0.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-0.52|-8.52|
71894178|NCT01982630|143310395|OTHER||Difference of Least Squares Means|1.73|||||TWO_SIDED|90.0|-2.38|5.83|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.83|-2.38|
71894179|NCT01982630|143310396|OTHER||Difference of Least Squares Means|-2.11|||||TWO_SIDED|90.0|-4.55|0.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||0.32|-4.55|
71803568|NCT01731171|143106148|SUPERIORITY||||||=|0.009|||||||Regression, Linear|||||||=.009
71803569|NCT01731171|143106149|SUPERIORITY||||||=|0.017|||||||Kruskal-Wallis|||||||=.017
71894180|NCT01982630|143310396|OTHER||Difference of Least Squares Means|2.53|||||TWO_SIDED|90.0|-0.61|5.66|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.66|-0.61|
71894181|NCT01982630|143310396|OTHER||Difference of Least Squares Means|4.64|||||TWO_SIDED|90.0|1.35|7.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||7.93|1.35|
71894182|NCT01982630|143310397|OTHER||Difference of Least Squares Means|-0.65|||||TWO_SIDED|90.0|-5.01|3.71|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||3.71|-5.01|
71894183|NCT01982630|143310397|OTHER||Difference of Least Squares Means|-6.42|||||TWO_SIDED|90.0|-10.66|-2.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-2.19|-10.66|
71894184|NCT01982630|143310397|OTHER||Difference of Least Squares Means|5.77|||||TWO_SIDED|90.0|1.57|9.97|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.97|1.57|
71803570|NCT01736852|143106156|NON_INFERIORITY|non-inferiority margin of 10%, α = 0.025, power = 0.80,||||||0.06|||||||Fisher Exact|||.ample size calculations were performed using an expected rate of 4% for each group,a one-sided exact test, α = 0.025, power = 0.80, non-inferiority margin of 10% resulting in a sample size of 124 patients or 62 patients per treatment arm.||||0.06
71803571|NCT03207750|143106163|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.|Difference in anti-D concentration|0.0|||||TWO_SIDED|95.0|-0.8|0.79||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.||0.79|-0.80|
71675285|NCT01908829|142868063|SUPERIORITY||LS Means|-0.52|STANDARD_ERROR_OF_MEAN|0.15|=|0.001|TWO_SIDED|95.0|-0.82|-0.22||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.22|-0.82|=0.001
71841333|NCT05623228|143191949|SUPERIORITY|||||||0||||||"Bonferroni correction p\<.05~F(1.25)=9.17 η=.254 (p\<.05)"|ANOVA|||||||.00
71841334|NCT05623228|143191949|SUPERIORITY|||||||0||||||Bonferroni correction p\<.05 F(2)=7.30 η=.213 (P\<.05)|ANOVA|||||||.00
71841335|NCT05623228|143191950|SUPERIORITY|||||||0.04||||||F(2)=3.20, η=.106 Bonferroni Correction p\<.05|ANOVA|||||||.04
71841336|NCT05623228|143191951|SUPERIORITY|||||||0||||||F(1,06)=8,11, η2=.231 Bonferroni correction p\<.05|ANOVA|||||||.00
71841337|NCT05623228|143191952|SUPERIORITY|||||||0.04||||||F(1,19)=4,30, η2=.137 Bonferroni correction p\<0.5|ANOVA|||||||.04
71841338|NCT05623228|143191953|SUPERIORITY|||||||0||||||t (38.70)|t-test, 1 sided|||||||.00
71841339|NCT04625725|143191994|SUPERIORITY||Relative Risk Reduction|76.73|||<|0.001|TWO_SIDED|95.0|46.05|89.96|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Primary Analysis||89.96|46.05|<0.001
71841340|NCT04625725|143191994|SUPERIORITY||Relative Risk Reduction|83.04|||<|0.001|TWO_SIDED|95.0|67.26|91.21|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|Final Analysis||91.21|67.26|<0.001
71841341|NCT04625725|143191996|SUPERIORITY||Relative Risk Reduction|34.9|||<|0.001|TWO_SIDED|95.0|21.44|46.05|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||46.05|21.44|<0.001
71841342|NCT04625725|143191997|SUPERIORITY||Relative Risk Reduction|91.41||||0.001|TWO_SIDED|95.0|61.31|98.09|||Poisson regression||Estimates are based on a Poisson regression with robust variance. The model includes covariate for treatment, and age group, with the log of the follow-up time as an offset. Estimated RRR greater than 0% provides evidence in favor of AZD7442.|||98.09|61.31|0.001
71841343|NCT04625725|143191998|SUPERIORITY||Relative Risk Reduction|52.43||||0.137|TWO_SIDED|95.0|-26.61|82.13|||Poisson regression|||||82.13|-26.61|0.137
71841344|NCT03298451|143192003|SUPERIORITY|||||||0.0035||||||The adjusted alpha levels (0.0398) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0035
71841345|NCT03298451|143192003|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.66|0.92|||Regression, Cox|||The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||0.92|0.66|
71841346|NCT03298451|143192004|NON_INFERIORITY|Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.67|0.73|1.03|||Regression, Cox||The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.||1.03|0.73|
71841347|NCT03298451|143192004|SUPERIORITY|Superiority was tested sequentially per protocol as non-inferiority was satisfied.||||||0.0674||||||The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.|Log Rank|||The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.||||0.0674
71841348|NCT05086796|143192020|SUPERIORITY||Risk Ratio (RR)|2.1|||||TWO_SIDED|97.5|1.51|2.91|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), prior exposure to MOUD (yes vs. no), and length of hospital stay in days.|2.91|1.51|
71675286|NCT01908829|142868063|SUPERIORITY||LS Means|-0.54|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.83|-0.25||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.25|-0.83|<0.001
71675287|NCT01908829|142868064|SUPERIORITY||LS Means|-0.26|STANDARD_ERROR_OF_MEAN|0.1|=|0.008|TWO_SIDED|95.0|-0.46|-0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.07|-0.46|=0.008
71675288|NCT01908829|142868064|SUPERIORITY||LS Means|-0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|-0.55|-0.13||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.13|-0.55|=0.002
71675289|NCT01908829|142868064|SUPERIORITY||LS Means|-0.28|STANDARD_ERROR_OF_MEAN|0.1|=|0.006|TWO_SIDED|95.0|-0.47|-0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.08|-0.47|=0.006
71675290|NCT01908829|142868064|SUPERIORITY||LS Means|-0.31|STANDARD_ERROR_OF_MEAN|0.1|=|0.002|TWO_SIDED|95.0|-0.51|-0.12||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group \& geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.12|-0.51|=0.002
71803572|NCT03207750|143106163|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.|Difference in anti-T concentration|0.0|||||TWO_SIDED|95.0|-0.79|0.77||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.||0.77|-0.79|
71803573|NCT03207750|143106164|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.|Difference in anti-HB concentration|-0.65|||||TWO_SIDED|95.0|-1.9|0.16||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.||0.16|-1.90|
71803574|NCT03207750|143106165|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.|Difference in anti-polio 1 concentration|0.21|||||TWO_SIDED|95.0|-0.6|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.||1.15|-0.60|
71803575|NCT03207750|143106165|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.|Difference in anti-polio 2 concentration|-0.01|||||TWO_SIDED|95.0|-1.02|0.98||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.||0.98|-1.02|
71841349|NCT05086796|143192021|SUPERIORITY||Risk Ratio (RR)|1.49|||||TWO_SIDED|97.5|1.15|1.93|||||The START arm is the numerator, Usual Care is the denominator. There are two primary outcome measures, so the type I error level was adjusted to alpha = 0.025.||Poisson regression was used to compare the proportions of participants who linked to follow-up OUD care by calculating the risk ratio (RR) and 97.5% confidence interval (CI) and with covariates treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|1.93|1.15|
71841350|NCT05086796|143192022|SUPERIORITY||Risk Ratio (RR)|1.8|||||TWO_SIDED|95.0|1.35|2.41|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who initiated MOUD in the hospital between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.41|1.35|
71675291|NCT01908829|142868065|SUPERIORITY||Rate Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.06|=|0.545|TWO_SIDED|95.0|0.87|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.87|=0.545
71675292|NCT01908829|142868065|SUPERIORITY||Rate Ratio|0.82|STANDARD_ERROR_OF_MEAN|0.08|=|0.01|TWO_SIDED|95.0|0.7|0.95||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.95|0.70|=0.010
71675293|NCT01908829|142868065|SUPERIORITY||Rate Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.09|=|0.007|TWO_SIDED|95.0|0.67|0.94||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.94|0.67|=0.007
71675294|NCT01908829|142868065|SUPERIORITY||Rate Ratio|0.78|STANDARD_ERROR_OF_MEAN|0.08|=|0.003|TWO_SIDED|95.0|0.66|0.92||p\<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination \& solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||0.92|0.66|=0.003
71675295|NCT01908829|142868066|SUPERIORITY||LS Means|-0.01|STANDARD_ERROR_OF_MEAN|0.05|=|0.836|TWO_SIDED|95.0|-0.1|0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.08|-0.10|=0.836
71803576|NCT03207750|143106165|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.|Difference in anti-polio 3 concentration|0.0|||||TWO_SIDED|95.0|-0.87|0.84||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.||0.84|-0.87|
71803577|NCT03207750|143106166|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.|GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.||1.03|0.86|
71803578|NCT03207750|143106166|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.||1.08|0.92|
71803579|NCT03207750|143106166|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.|GMC ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.||1.10|0.86|
71803580|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.||1.14|0.93|
71894185|NCT01982630|143310397|OTHER||Difference of Least Squares Means|-0.15|||||TWO_SIDED|90.0|-4.29|4.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.00|-4.29|
71894186|NCT01982630|143310397|OTHER||Difference of Least Squares Means|-5.91|||||TWO_SIDED|90.0|-9.91|-1.92|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||-1.92|-9.91|
71803581|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.91|1.11|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.||1.11|0.91|
71803582|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.09|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.||1.09|0.90|
71803583|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.|GMC ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.||1.17|0.94|
71803584|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.|GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.||1.12|0.92|
71803585|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.|GMC ratio|0.96|||||TWO_SIDED|95.0|0.83|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.||1.12|0.83|
71803586|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.|GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.||1.08|0.91|
71803587|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.||1.14|0.93|
71803588|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.|GMC ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.||1.13|0.89|
71803589|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.92|1.14|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.||1.14|0.92|
71894187|NCT01982630|143310397|OTHER||Difference of Least Squares Means|0.51|||||TWO_SIDED|90.0|-3.6|4.62|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||4.62|-3.60|
71894188|NCT01982630|143310398|OTHER||Difference of Least Squares Means|-0.89|||||TWO_SIDED|90.0|-3.8|2.02|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.02|-3.80|
71894189|NCT01982630|143310398|OTHER||Difference of Least Squares Means|5.24|||||TWO_SIDED|90.0|1.34|9.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||9.15|1.34|
71894190|NCT01982630|143310398|OTHER||Difference of Least Squares Means|6.13|||||TWO_SIDED|90.0|2.05|10.22|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||10.22|2.05|
71894191|NCT01982630|143310399|OTHER||Difference of Least Squares Means|-0.57|||||TWO_SIDED|90.0|-3.71|2.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||2.57|-3.71|
71894192|NCT01982630|143310399|OTHER||Difference of Least Squares Means|7.77|||||TWO_SIDED|90.0|3.5|12.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.03|3.50|
71803590|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.|GMC ratio|1.04|||||TWO_SIDED|95.0|0.93|1.15|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.||1.15|0.93|
71803591|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.|GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.12|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.||1.12|0.95|
71803592|NCT03207750|143106167|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.|GMC ratio|0.98|||||TWO_SIDED|95.0|0.87|1.1|||ANOVA|ANOVA model that included the vaccine group as fixed effect.||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.||1.10|0.87|
71803593|NCT03207750|143106168|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.|Difference in anti-PRP concentration|0.17|||||TWO_SIDED|95.0|-1.94|2.28||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.||2.28|-1.94|
71803594|NCT03207750|143106169|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.|Difference in anti-PRP concentration|-0.88|||||TWO_SIDED|95.0|-5.75|3.99||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.||3.99|-5.75|
71803595|NCT03207750|143106170|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PT antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
71803596|NCT03207750|143106170|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for FHA antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV lyophilized group||To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
71803597|NCT03207750|143106170|OTHER|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be \<=0.025 for PRN antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 \& the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.||||<.0001
71803598|NCT01700946|143106209|SUPERIORITY|||||||0.035|||||||Log Rank|||||||0.035
71803599|NCT01700946|143106210|SUPERIORITY|||||||0.105|||||||Log Rank|||||||0.105
71841351|NCT05086796|143192023|SUPERIORITY||Risk Ratio (RR)|1.71|||||TWO_SIDED|95.0|1.23|2.39|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported any post-discharge MOUD utilization between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: treatment arm, site (3 sites), and prior exposure to MOUD (yes vs. no).|2.39|1.23|
71841352|NCT05086796|143192024|SUPERIORITY||Risk Ratio (RR)|1.89|||||TWO_SIDED|95.0|1.18|3.03|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable Poisson regression was used to compare the proportions of participants who reported receiving any post-discharge outpatient medical care for their OUD between arms by calculating the risk ratio (RR) and 95% confidence interval (CI) with covariates: site (3 sites), and prior exposure to MOUD (yes vs. no).|3.03|1.18|
71803600|NCT01700946|143106211|SUPERIORITY|||||||0.1181|||||||Fisher Exact|||||||0.1181
71803601|NCT01168934|143106223|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|43.44|||||TWO_SIDED|90.0|39.68|47.56||||||Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||47.56|39.68|
71803602|NCT01168934|143106226|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|44.67|||||TWO_SIDED|90.0|40.9|48.78||||||Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||48.78|40.90|
71803603|NCT01504438|143106247|OTHER|||||||0.29|||||||ANOVA|||||||0.29
71803604|NCT01504438|143106248|OTHER|||||||0.31|||||||ANOVA|||||||0.31
71841353|NCT05086796|143192025|SUPERIORITY||Incident rate ratio|1.25|||||TWO_SIDED|95.0|0.64|2.43|||||The START arm is the numerator, Usual Care is the denominator.||Multivariable negative binomial regression with a log link function was used to compare opioid use-days between the two treatment arms by calculating the incident rate ratio (IRR) and 95% confidence interval (CI) with covariates: site (3 sites), prior exposure to MOUD (yes vs. no), and baseline opioid use days.|2.43|0.64|
71841354|NCT04231331|143192030|SUPERIORITY||||||<|0.001||||||P-value \<0.05 was considered statistically significant.|t-test, 2 sided|||Based on our previous study, we assumed a common baseline mean EROA of 0.21 cm2 with a common standard deviation of 0.11 cm2. Given these assumptions, we calculated that a sample size of 204 patients randomly assigned to two groups, would provide 90% power to detect a difference of 0.05 cm2 in the EROA between the ertugliflozin and placebo groups, using a two-sided t test with an alpha level of 0.05.||||<0.001
71841355|NCT01651403|143192039|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||< 0.001
71841356|NCT01651403|143192039|SUPERIORITY||||||<|0.001|||||||Fisher Exact|Fisher's exact test without adjusting for strata at baseline||||||< 0.001
71841357|NCT01651403|143192040|SUPERIORITY|||||||0.935|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||0.935
71841358|NCT01651403|143192041|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.001
71894193|NCT01982630|143310399|OTHER||Difference of Least Squares Means|8.34|||||TWO_SIDED|90.0|3.89|12.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.79|3.89|
71803605|NCT01504438|143106249|OTHER|||||||0.07|||||||ANOVA|||||||0.07
71803606|NCT01504438|143106250|OTHER|||||||0.04|||||||ANOVA|||||||0.04
71841359|NCT01651403|143192043|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
71803607|NCT04177108|143106304|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0098||95.0|0.28|0.85|||Log Rank|||||0.85|0.28|0.0098
71803608|NCT04177108|143106304|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.2396||95.0|0.42|1.25|||Log Rank|||||1.25|0.42|0.2396
71803609|NCT04177108|143106304|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9809||95.0|0.63|1.58|||Log Rank|||||1.58|0.63|0.9809
71803610|NCT04177108|143106305|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6805||95.0|0.55|2.51|||Log Rank|||||2.51|0.55|0.6805
71803611|NCT04177108|143106305|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.6314||95.0|0.55|2.64|||Log Rank|||||2.64|0.55|0.6314
71803612|NCT04177108|143106305|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9164||95.0|0.52|2.06|||Log Rank|||||2.06|0.52|0.9164
71841360|NCT01651403|143192045|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||0.002
71803613|NCT01827904|143106312|SUPERIORITY|Percent change from Baseline at the 3 Month visit in the Exablate test vs. Sham control arms was tested using the t-test.|||||<|0.001|||||||t-test, 1 sided|alpha = 0.05 for the hypothesis test. H0: M3ExAblate ≤ M3Sham H1: M3ExAblate \> M3Sham||"Note that the Crossover group was a rescue treatment group and not integral to the experimental design statistical analysis."||||<0.001
71803614|NCT02670629|143106324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
71803615|NCT01344460|143106327|SUPERIORITY_OR_OTHER||Percentage difference|18.3|||<|0|TWO_SIDED|95.0|15.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||15.2|<0.000
71803616|NCT01344460|143106327|SUPERIORITY_OR_OTHER||Percentage difference|16.4|||<|0|TWO_SIDED|95.0|13.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||13.2|<0.000
71841361|NCT01651403|143192047|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
71841362|NCT01651403|143192049|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
71841363|NCT01651403|143192051|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata||||||<0.001
71841364|NCT01651403|143192053|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
71841365|NCT01651403|143192055|SUPERIORITY||||||>|0.999|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||>0.999
71841366|NCT01651403|143192063|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
71841367|NCT01651403|143192064|OTHER|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||TWO_SIDED|95.0|-6.9|25.1||||||||25.1|-6.9|
71841368|NCT01651403|143192065|SUPERIORITY|||||||0.007|||||||ANOVA|two-sided superiority test||||||0.007
71841369|NCT01651403|143192067|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata||||||<0.001
71894194|NCT01982630|143310400|OTHER||Difference of Least Squares Means|1.35|||||TWO_SIDED|90.0|-2.4|5.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||5.09|-2.40|
71675296|NCT01908829|142868066|SUPERIORITY||LS Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05|=|0.617|TWO_SIDED|95.0|-0.12|0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.07|-0.12|=0.617
71803617|NCT01344460|143106327|SUPERIORITY_OR_OTHER||Percentage difference|24.0|||<|0|TWO_SIDED|95.0|20.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||20.5|<0.000
71803618|NCT01344460|143106327|SUPERIORITY_OR_OTHER||Percentage difference|17.4|||<|0|TWO_SIDED|95.0|14.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||14.3|<0.000
71803619|NCT01344460|143106327|SUPERIORITY_OR_OTHER||Percentage difference|25.6|||<|0|TWO_SIDED|95.0|21.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||21.9|<0.000
71803620|NCT01344460|143106328|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|6.8|||||TWO_SIDED|95.0|-2.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-2.2|
71841370|NCT05873556|143192109|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.97||||0.83|TWO_SIDED|95.0|0.74|1.27|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.27|0.74|0.83
71803621|NCT01344460|143106328|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|0.0|||||TWO_SIDED|95.0|-9.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-9.7|
71803622|NCT01344460|143106328|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|14.3|||||TWO_SIDED|95.0|5.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||5.1|
71803623|NCT01344460|143106328|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|3.0|||||TWO_SIDED|95.0|-5.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||-5.8|
71803624|NCT01344460|143106328|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|20.0|||||TWO_SIDED|95.0|11.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.7|
71803625|NCT01344460|143106329|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.0|||||TWO_SIDED|95.0|7.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.0|
71803626|NCT01344460|143106329|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|11.3|||||TWO_SIDED|95.0|9.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||9.1|
71803627|NCT01344460|143106329|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||TWO_SIDED|95.0|7.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||7.6|
71803628|NCT01344460|143106329|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.4|||||TWO_SIDED|95.0|11.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.2|
71803629|NCT01344460|143106329|NON_INFERIORITY_OR_EQUIVALENCE|using a -7.5% non-inferiority margin|Percentage difference|13.1|||||TWO_SIDED|95.0|11.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||The cluster-adjusted two-sided 95% CI|||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|||11.0|
71803630|NCT01344460|143106330|SUPERIORITY_OR_OTHER||percentage|54.6|||||ONE_SIDED|95.0|46.2||||One sided 95% confidence interval|||Majority reader|||46.2|
71675297|NCT01908829|142868066|SUPERIORITY||LS Means|-0.07|STANDARD_ERROR_OF_MEAN|0.05|=|0.134|TWO_SIDED|95.0|-0.17|0.02||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.02|-0.17|=0.134
71675298|NCT01908829|142868066|SUPERIORITY||LS Means|-0.06|STANDARD_ERROR_OF_MEAN|0.05|=|0.174|TWO_SIDED|95.0|-0.16|0.03||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.03|-0.16|=0.174
71675299|NCT01908829|142868067|SUPERIORITY||Rate Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04|=|0.993|TWO_SIDED|95.0|0.93|1.08||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.08|0.93|=0.993
71675300|NCT01908829|142868067|SUPERIORITY||Rate Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.04|=|0.736|TWO_SIDED|95.0|0.9|1.07||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.07|0.90|=0.736
71803631|NCT01344460|143106330|SUPERIORITY_OR_OTHER||percentage|51.6|||||ONE_SIDED|95.0|43.6||||One sided 95% confidence interval|||Blinded Reader 1|||43.6|
71803632|NCT01344460|143106330|SUPERIORITY_OR_OTHER||percentage|54.4|||||ONE_SIDED|95.0|45.5||||One sided 95% confidence interval|||Blinded Reader 2|||45.5|
71803633|NCT01344460|143106330|SUPERIORITY_OR_OTHER||percentage|53.4|||||ONE_SIDED|95.0|44.8||||One sided 95% confidence interval|||Blinded Reader 3|||44.8|
71803634|NCT01344460|143106330|SUPERIORITY_OR_OTHER||percentage|71.3|||||ONE_SIDED|95.0|64.7||||One sided 95% confidence interval|||Clinical investigator|||64.7|
71803635|NCT01344460|143106331|SUPERIORITY_OR_OTHER||percentage|95.9|||||ONE_SIDED|95.0|94.9||||One sided 95% confidence interval|||Majority reader|||94.9|
71803636|NCT01344460|143106331|SUPERIORITY_OR_OTHER||percentage|95.0|||||ONE_SIDED|95.0|93.8||||One sided 95% confidence interval|||Blinded Reader 1|||93.8|
71803637|NCT01344460|143106331|SUPERIORITY_OR_OTHER||percentage|96.2|||||ONE_SIDED|95.0|95.2||||One sided 95% confidence interval|||Blinded Reader 2|||95.2|
71894195|NCT01982630|143310400|OTHER||Difference of Least Squares Means|8.29|||||TWO_SIDED|90.0|3.29|13.3|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||13.30|3.29|
71894196|NCT01982630|143310400|OTHER||Difference of Least Squares Means|6.95|||||TWO_SIDED|90.0|1.69|12.2|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.20|1.69|
71803638|NCT01344460|143106331|SUPERIORITY_OR_OTHER||percentage|95.8|||||ONE_SIDED|95.0|94.8||||One sided 95% confidence interval|||Blinded Reader 3|||94.8|
71803639|NCT01344460|143106331|SUPERIORITY_OR_OTHER||percentage|98.4|||||ONE_SIDED|95.0|97.8||||One sided 95% confidence interval|||Clinical investigator|||97.8|
71803640|NCT01344460|143106334|SUPERIORITY_OR_OTHER||Diameter difference|0.17|STANDARD_DEVIATION|1.28|||||||||Mean Difference|||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point||||
71803641|NCT01344460|143106334|SUPERIORITY_OR_OTHER||Diameter difference|-0.09|STANDARD_DEVIATION|1.14|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point||||
71803642|NCT01344460|143106334|SUPERIORITY_OR_OTHER||Mean Difference|0.41|STANDARD_DEVIATION|1.15|||||||||Mean Difference|||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point||||
71803643|NCT01344460|143106334|SUPERIORITY_OR_OTHER||Diameter difference|-0.15|STANDARD_DEVIATION|1.01|||||||||Mean Difference|||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point||||
71803644|NCT03285477|143106349|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
71675301|NCT01908829|142868067|SUPERIORITY||Rate Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.05|=|0.121|TWO_SIDED|95.0|0.85|1.02||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.02|0.85|=0.121
71803645|NCT03285477|143106350|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
71675302|NCT01908829|142868067|SUPERIORITY||Rate Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.04|=|0.172|TWO_SIDED|95.0|0.86|1.03||p\<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, \& p-value for number of nocturia episodes during 3-day diary between combination \& solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (\<65, \>=65 years), geographic region \& 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.||1.03|0.86|=0.172
71675303|NCT01908829|142868073|SUPERIORITY||LS Means|-2.89|STANDARD_ERROR_OF_MEAN|0.91|=|0.002|TWO_SIDED|95.0|-4.68|-1.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-1.10|-4.68|=0.002
71675304|NCT01908829|142868073|SUPERIORITY||LS Means|-4.5|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|-6.4|-2.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-2.60|-6.40|<0.001
71675305|NCT01908829|142868073|SUPERIORITY||LS Means|-5.59|STANDARD_ERROR_OF_MEAN|1.0|<|0.001|TWO_SIDED|95.0|-7.56|-3.62||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.62|-7.56|<0.001
71675306|NCT01908829|142868073|SUPERIORITY||LS Means|-4.96|STANDARD_ERROR_OF_MEAN|0.98|<|0.001|TWO_SIDED|95.0|-6.88|-3.04||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-3.04|-6.88|<0.001
71675307|NCT01908829|142868074|SUPERIORITY||LS Means|1.92|STANDARD_ERROR_OF_MEAN|0.83|=|0.021|TWO_SIDED|95.0|0.29|3.55||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.55|0.29|=0.021
71803646|NCT03283670|143106361|SUPERIORITY||Mean Difference (Net)|-0.75||||0.55|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 25% nitrous oxide||||0.55
71803647|NCT03283670|143106361|SUPERIORITY||Mean Difference (Net)|-1.4||||0.47|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21, 25% nitrous oxide vs placebo at 24 hours||||0.47
71803648|NCT03283670|143106361|SUPERIORITY||Median Difference (Net)|-0.87||||0.49|TWO_SIDED||||||t-test, 2 sided|||HAMD-21 at 2 Hours, placebo vs 50% nitrous oxide||||0.49
71803649|NCT03283670|143106361|SUPERIORITY||Mean Difference (Net)|-1.9||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, placebo vs 50% nitrous oxide||||0.34
71803650|NCT03283670|143106361|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.94|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 2 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.94
71803651|NCT03283670|143106361|SUPERIORITY||Mean Difference (Net)|-0.5||||0.8|TWO_SIDED||||||t-test, 2 sided|||Change in HAMD-21 at 24 hours, 25% nitrous oxide vs 50% nitrous oxide||||0.80
71803652|NCT01085318|143106362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|864.1||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
71803653|NCT01085318|143106363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|644.99|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71803654|NCT04286594|143106385|OTHER|Change in single group over time|Mean Difference (Final Values)|11.667|STANDARD_DEVIATION|5.051|<|0.001|TWO_SIDED|95.0|8.457|14.876|||t-test, 1 sided|||||14.876|8.457|<0.001
71803655|NCT05932290|143106418|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Regression, Cox||Hazard ratios (HRs) were estimated using unadjusted Cox proportional hazard models.|||0.71|0.37|<.0001
71803656|NCT05932290|143106419|SUPERIORITY||Hazard Ratio (HR)|0.37||||0.0003|TWO_SIDED|95.0|0.22|0.64|||Regression, Cox||IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.|||0.64|0.22|.0003
71803657|NCT05932290|143106422|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0062|TWO_SIDED|95.0|0.47|0.88|||Regression, Cox||HRs were estimated using unadjusted Cox proportional hazard models.|||0.88|0.47|.0062
71803658|NCT05932290|143106423|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.0032|TWO_SIDED|95.0|0.27|0.77|||Regression, Cox|IPTW HRs were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances.||||0.77|0.27|.0032
71803659|NCT02203019|143106435|EQUIVALENCE|Outcome comparison used the Mann Whitney U test||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
71803660|NCT02203019|143106436|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.260
71803661|NCT02203019|143106437|EQUIVALENCE|Outcomes were compared using a Mann Whitney U test.||||||0.376|||||||Wilcoxon (Mann-Whitney)|||||||0.376
71841371|NCT05873556|143192109|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.07||||0.61|TWO_SIDED|95.0|0.83|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.83|0.61
71841372|NCT05873556|143192110|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.16||||0.45|TWO_SIDED|95.0|0.79|1.72|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.72|0.79|0.45
71841373|NCT05873556|143192110|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.17||||0.46|TWO_SIDED|95.0|0.77|1.79|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.79|0.77|0.46
71841374|NCT05873556|143192111|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.62|TWO_SIDED|95.0|0.77|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.17|0.77|0.62
71841375|NCT05873556|143192111|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.14||||0.34|TWO_SIDED|95.0|0.87|1.48|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.48|0.87|0.34
71841376|NCT05873556|143192112|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|1.08||||0.66|TWO_SIDED|95.0|0.76|1.54|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.54|0.76|0.66
71841377|NCT05873556|143192112|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.02||||0.92|TWO_SIDED|95.0|0.75|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.75|0.92
71841378|NCT02038777|143192148|OTHER||||||<|0.0001||||||An exact test for a single proportion (1-sided significance level: 0.05) was used.|Exact test for a single proportion|||||||<.0001
71803662|NCT02203019|143106438|EQUIVALENCE|Outcomes were compared using a Chi square test.||||||0.739|||||||Chi-squared|||||||0.739
71803663|NCT02031276|143106439|OTHER||difference in percentage of participants|12.6||||0.0955|TWO_SIDED|95.0|-2.2|27.5|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-tumor necrosis factor (anti-TNF) exposure.||27.5|-2.2|0.0955
71803664|NCT02031276|143106440|OTHER||difference in percentage of participants|13.4||||0.1151|TWO_SIDED|95.0|-3.3|30.1|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||30.1|-3.3|0.1151
71803665|NCT02031276|143106441|OTHER||difference in percentage of participants|12.0||||0.0057|TWO_SIDED|95.0|3.5|20.6|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||20.6|3.5|0.0057
71841379|NCT03676192|143192221|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 95% confidence interval (CI) of the difference of ORR from each treatment group was entirely bounded by the interval (-12.5, 12.5).|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-7.02|7.83||||||Logistic regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||7.83|-7.02|
71841380|NCT03676192|143192221|EQUIVALENCE|The similarity criterion had been set such that the confidence limits of the 90% confidence interval (CI) of the ratio of ORR from each treatment group was entirely bounded by the interval (0.7368, 1.3572).|Risk Ratio (RR)|1.0136|||||TWO_SIDED|90.0|0.8767|1.1719||||||Log-binomial regression model including treatment groups (CT-P16 and EU-approved Avastin) as a fixed effect and region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as covariates was used.||1.1719|0.8767|
71803666|NCT02031276|143106442|OTHER||difference in percentage of participants|18.7||||0.0104|TWO_SIDED|95.0|4.4|33.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||33.0|4.4|0.0104
71803667|NCT02031276|143106443|OTHER||difference in percentage of participants|2.4||||0.4977|TWO_SIDED|95.0|-4.5|9.2|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||9.2|-4.5|0.4977
71803668|NCT02031276|143106444|OTHER||difference in percentage of participants|7.4||||0.0107|TWO_SIDED|95.0|1.7|13.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.||13.0|1.7|0.0107
71803669|NCT01854554|143106445|SUPERIORITY|||||||0.74|||||||Gray's test|Cumulative Incidence Function treating progressive disease (RANO) or death before cognitive function decline as a competing risk.||||||.74
71803670|NCT01854554|143106446|SUPERIORITY|||||||0.6|||||||Log Rank|||||||.60
71803671|NCT01854554|143106447|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
71803672|NCT02509624|143106449|OTHER||%Geometric least-square mean(GLSM) ratio|105.08|||||TWO_SIDED|90.0|77.08|143.23||||||AUCinf of selonsertib||143.23|77.08|
71803673|NCT02509624|143106449|OTHER||% GLSM ratio|142.65|||||TWO_SIDED|90.0|120.52|168.84||||||AUCinf of selonsertib||168.84|120.52|
71803674|NCT02509624|143106449|OTHER||% GLSM ratio|110.55|||||TWO_SIDED|90.0|86.99|140.49||||||AUCinf of selonsertib||140.49|86.99|
71803675|NCT02509624|143106449|OTHER||% GLSM ratio|62.05|||||TWO_SIDED|90.0|43.84|87.81||||||AUCinf of GS-607509||87.81|43.84|
71803676|NCT02509624|143106449|OTHER||% GLSM ratio|66.44|||||TWO_SIDED|90.0|36.72|120.21||||||AUCinf of GS-607509||120.21|36.72|
71803677|NCT02509624|143106449|OTHER||% GLSM ratio|103.46|||||TWO_SIDED|90.0|51.75|206.83||||||AUCinf of GS-607509||206.83|51.75|
71803678|NCT02509624|143106450|OTHER||% GLSM ratio|99.87|||||TWO_SIDED|90.0|73.38|135.92||||||AUClast of selonsertib||135.92|73.38|
71803679|NCT02509624|143106450|OTHER||% GLSM ratio|141.75|||||TWO_SIDED|90.0|118.5|169.55||||||AUClast of selonsertib||169.55|118.50|
71803680|NCT02509624|143106450|OTHER||% GLSM ratio|112.24|||||TWO_SIDED|90.0|87.69|143.65||||||AUClast of selonsertib||143.65|87.69|
71803681|NCT02509624|143106450|OTHER||% GLSM ratio|61.2|||||TWO_SIDED|90.0|43.06|86.98||||||AUClast of GS-607509||86.98|43.06|
71803682|NCT02509624|143106450|OTHER||% GLSM ratio|61.07|||||TWO_SIDED|90.0|33.62|110.91||||||AUClast of GS-607509||110.91|33.62|
71803683|NCT02509624|143106450|OTHER||% GLSM ratio|96.13|||||TWO_SIDED|90.0|48.47|190.67||||||AUClast of GS-607509||190.67|48.47|
71803684|NCT02509624|143106451|OTHER||% GLSM ratio|88.68|||||TWO_SIDED|90.0|74.83|105.1||||||Cmax of selonsertib||105.10|74.83|
71803685|NCT02509624|143106451|OTHER||% GLSM ratio|91.16|||||TWO_SIDED|90.0|78.76|105.52||||||Cmax of selonsertib||105.52|78.76|
71803686|NCT02509624|143106451|OTHER||% GLSM ratio|100.19|||||TWO_SIDED|90.0|83.73|119.88||||||Cmax of selonsertib||119.88|83.73|
71803687|NCT02509624|143106451|OTHER||% GLSM ratio|71.44|||||TWO_SIDED|90.0|54.58|93.5||||||Cmax of GS-607509||93.50|54.58|
71803688|NCT02509624|143106451|OTHER||% GLSM ratio|46.92|||||TWO_SIDED|90.0|32.59|67.54||||||Cmax of GS-607509||67.54|32.59|
71803689|NCT02509624|143106451|OTHER||% GLSM ratio|93.93|||||TWO_SIDED|90.0|67.6|130.5||||||Cmax of GS-607509||130.50|67.60|
71803690|NCT02819726|143106454|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|95.33|||||TWO_SIDED|90.0|87.07|104.37||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||104.37|87.07|
71803691|NCT02819726|143106454|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|93.43|||||TWO_SIDED|90.0|85.54|102.15||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.15|85.54|
71803692|NCT02819726|143106454|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.06|||||TWO_SIDED|90.0|89.49|107.45||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment||107.45|89.49|
71803693|NCT02819726|143106455|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.07|||||TWO_SIDED|90.0|86.91|101.81||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.81|86.91|
71803694|NCT02819726|143106455|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|94.39|||||TWO_SIDED|90.0|87.21|102.16||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.16|87.21|
71803695|NCT02819726|143106455|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|100.35|||||TWO_SIDED|90.0|92.68|108.65||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||108.65|92.68|
71803696|NCT02819726|143106456|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|96.31|||||TWO_SIDED|90.0|90.52|102.46||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.46|90.52|
71803697|NCT02819726|143106456|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.65|||||TWO_SIDED|90.0|92.64|105.05||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.05|92.64|
71803698|NCT02819726|143106456|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.43|||||TWO_SIDED|90.0|96.14|109.14||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||109.14|96.14|
71803699|NCT02819726|143106457|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.93|||||TWO_SIDED|90.0|89.03|101.23||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||101.23|89.03|
71803700|NCT02819726|143106457|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.75|||||TWO_SIDED|90.0|92.61|105.3||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||105.30|92.61|
71803701|NCT02819726|143106457|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|104.03|||||TWO_SIDED|90.0|97.54|110.95||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||110.95|97.54|
71803702|NCT02819726|143106458|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|89.08|||||TWO_SIDED|90.0|77.2|102.79||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||102.79|77.20|
71803703|NCT02819726|143106458|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.56|||||TWO_SIDED|90.0|88.72|118.56||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||118.56|88.72|
71803704|NCT02819726|143106458|EQUIVALENCE|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|115.13|||||TWO_SIDED|90.0|99.51|133.21||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment||133.21|99.51|
71803705|NCT02819726|143106459|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.134||0.2402|TWO_SIDED|95.0|-0.422|0.106|||ANCOVA|||Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.106|-0.422|0.2402
71803706|NCT02819726|143106459|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.135||0.1346|TWO_SIDED|95.0|-0.469|0.063|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.063|-0.469|0.1346
71803707|NCT02819726|143106459|EQUIVALENCE|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of \[-0.6,0.6\]|LS Means Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7429|TWO_SIDED|95.0|-0.314|0.224|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only||0.224|-0.314|0.7429
71803708|NCT02819726|143106468|OTHER||LS Means Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.172||0.6068|TWO_SIDED|95.0|-0.428|0.25|||ANCOVA|||Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.250|-0.428|0.6068
71803709|NCT02819726|143106468|OTHER||LS Means Difference|0.09|STANDARD_ERROR_OF_MEAN|0.172||0.599|TWO_SIDED|95.0|-0.249|0.43|||ANCOVA|||Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.249|0.5990
71803710|NCT02819726|143106468|OTHER||LS Means Difference|0.18|STANDARD_ERROR_OF_MEAN|0.175||0.3053|TWO_SIDED|95.0|-0.165|0.532|||ANCOVA|||Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.||0.532|-0.165|0.3053
71803711|NCT02819726|143106469|OTHER||Difference (%)|9.4|STANDARD_ERROR_OF_MEAN|7.22|||TWO_SIDED|95.0|-4.74|23.03||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||23.03|-4.74|
71803712|NCT02819726|143106469|OTHER||Difference (%)|-2.5|STANDARD_ERROR_OF_MEAN|7.05|||TWO_SIDED|95.0|-15.95|11.22||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||11.22|-15.95|
71803713|NCT02819726|143106469|OTHER||Difference (%)|-11.8|STANDARD_ERROR_OF_MEAN|7.26|||TWO_SIDED|95.0|-25.47|2.45||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.||2.45|-25.47|
71803714|NCT02819726|143106470|OTHER||Difference (%)|9.5|STANDARD_ERROR_OF_MEAN|6.87|||TWO_SIDED|95.0|-4.07|22.46||||||ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||22.46|-4.07|
71803715|NCT02819726|143106470|OTHER||Difference (%)|3.5|STANDARD_ERROR_OF_MEAN|7.07|||TWO_SIDED|95.0|-10.22|17.03||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.03|-10.22|
71803716|NCT02819726|143106470|OTHER||Difference (%)|-5.9|STANDARD_ERROR_OF_MEAN|6.88|||TWO_SIDED|95.0|-19.1|7.51||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||7.51|-19.10|
71803717|NCT02819726|143106470|OTHER||Difference (%)|10.0|STANDARD_ERROR_OF_MEAN|5.78|||TWO_SIDED|95.0|-1.52|21.22||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||21.22|-1.52|
71803718|NCT02819726|143106470|OTHER||Difference|5.4|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-6.69|17.13||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||17.13|-6.69|
71803719|NCT02819726|143106470|OTHER||Difference (%)|-4.7|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|92.0|-15.68|6.41||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.||6.41|-15.68|
71894197|NCT01982630|143310401|OTHER||Difference of Least Squares Means|2.46|||||TWO_SIDED|90.0|-1.42|6.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||6.34|-1.42|
71803720|NCT02819726|143106471|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|0.991||0.1997|TWO_SIDED|95.0|-3.23|0.671|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.671|-3.230|0.1997
71803721|NCT02819726|143106471|OTHER||LS Means Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.996||0.9098|TWO_SIDED|95.0|-2.074|1.848|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||1.848|-2.074|0.9098
71803722|NCT02819726|143106471|OTHER||LS Means Difference|1.17|STANDARD_ERROR_OF_MEAN|1.008||0.248|TWO_SIDED|95.0|-0.817|3.15|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||3.150|-0.817|0.2480
71803723|NCT02819726|143106471|OTHER||LS Means Difference|-1.96|STANDARD_ERROR_OF_MEAN|1.5||0.1931|TWO_SIDED|95.0|-4.909|0.996|||ANCOVA|||Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||0.996|-4.909|0.1931
71803724|NCT02819726|143106471|OTHER||LS Means Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.5||-0.77|TWO_SIDED|95.0|-3.722|2.184|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||2.184|-3.722|-0.77
71803725|NCT02819726|143106471|OTHER||LS Means Difference|1.19|STANDARD_ERROR_OF_MEAN|1.52||0.4352|TWO_SIDED|95.0|-1.805|4.18|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.||4.180|-1.805|0.4352
71803726|NCT02819726|143106472|OTHER||LS Means Difference|-4.16|STANDARD_ERROR_OF_MEAN|3.242||0.2008|TWO_SIDED|95.0|-10.541|2.226|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||2.226|-10.541|0.2008
71803727|NCT02819726|143106472|OTHER||LS Means Difference|-0.39|STANDARD_ERROR_OF_MEAN|3.242||-0.39|TWO_SIDED|95.0|-6.771|5.994|||ANOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||5.994|-6.771|-0.39
71803728|NCT02819726|143106472|OTHER||LS Means Difference|3.77|STANDARD_ERROR_OF_MEAN|3.268||0.2498|TWO_SIDED|95.0|-2.665|10.204|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline||10.204|-2.665|0.2498
71803729|NCT02819726|143106473|OTHER||LS Means Difference|-1.23|STANDARD_ERROR_OF_MEAN|3.592||0.7322|TWO_SIDED|95.0|-8.0302|5.841|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.841|-8.0302|0.7322
71803730|NCT02819726|143106473|OTHER||LS Means Difference|-2.21|STANDARD_ERROR_OF_MEAN|3.623||0.5418|TWO_SIDED|95.0|-9.347|4.92|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||4.920|-9.347|0.5418
71803731|NCT02819726|143106473|OTHER||LS Means Difference|-0.98|STANDARD_ERROR_OF_MEAN|3.633||0.7869|TWO_SIDED|95.0|-8.136|6.169|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||6.169|-8.136|0.7869
71803732|NCT02819726|143106474|OTHER||LS Means Difference|-1.28|STANDARD_ERROR_OF_MEAN|3.443||0.7097|TWO_SIDED|95.0|-8.062|5.496|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.496|-8.062|0.7097
71803733|NCT02819726|143106474|OTHER||LS Means Difference|-1.48|STANDARD_ERROR_OF_MEAN|3.453||0.6683|TWO_SIDED|95.0|-8.28|5.317|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||5.317|-8.280|0.6683
71803734|NCT02819726|143106474|OTHER||LS Means Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.494||0.9548|TWO_SIDED|95.0|-7.078|6.682|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)||6.682|-7.078|0.9548
71803735|NCT02819726|143106475|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.0505|TWO_SIDED|95.0|-0.339|0.0|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.000|-0.339|0.0505
71803736|NCT02819726|143106475|OTHER||LS Means Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.086||0.1141|TWO_SIDED|95.0|-0.307|0.033|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.033|-0.307|0.1141
71803737|NCT02819726|143106475|OTHER||LS Means Difference|0.03|STANDARD_ERROR_OF_MEAN|0.087||0.7111|TWO_SIDED|95.0|-0.139|0.204|||ANCOVA|||Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||0.204|-0.139|0.7111
71803738|NCT02819726|143106476|OTHER||LS Means Difference|-0.43|STANDARD_ERROR_OF_MEAN|1.871||0.8183|TWO_SIDED|95.0|-4.113|3.253|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||3.253|-4.113|0.8183
71803739|NCT02819726|143106476|OTHER||LS Means Difference|1.51|STANDARD_ERROR_OF_MEAN|1.868||0.4186|TWO_SIDED|95.0|-2.164|5.191|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.191|-2.164|0.4186
71803740|NCT02819726|143106476|OTHER||LS Means Difference|1.94|STANDARD_ERROR_OF_MEAN|1.885||0.3035|TWO_SIDED|95.0|-1.768|5.655|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).||5.655|-1.768|0.3035
71803741|NCT02819726|143106477|OTHER||LS Means Difference|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9249|TWO_SIDED|95.0|-0.375|0.413|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.413|-0.375|0.9249
71803742|NCT02819726|143106477|OTHER||LS Measn Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.05|TWO_SIDED|95.0|-0.351|0.442|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.442|-0.351|0.05
71803743|NCT02819726|143106477|OTHER||LS Means Diference|0.03|STANDARD_ERROR_OF_MEAN|0.205||0.8962|TWO_SIDED|95.0|-0.376|0.43|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.||0.430|-0.376|0.8962
71803744|NCT02819726|143106478|OTHER||Difference (%)|2.2|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-2.56|7.83||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||7.83|-2.56|
71803745|NCT02819726|143106478|OTHER||Difference (%)|1.0|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-4.74|6.67||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||6.67|-4.74|
71803746|NCT02819726|143106478|OTHER||Difference (%)|-1.3|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|95.0|-6.75|3.39||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.39|-6.75|
71803747|NCT02819726|143106479|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|95.0|-6.9|3.9||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.90|-6.9|
71803748|NCT02819726|143106479|OTHER||Difference (%)|-1.2|STANDARD_ERROR_OF_MEAN|1.95|||TWO_SIDED|95.0|-7.07|3.86||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||3.86|-7.07|
71803749|NCT02819726|143106479|OTHER||Differnce (%)|-0.1|STANDARD_ERROR_OF_MEAN|2.27|||TWO_SIDED|95.0|-6.05|5.83||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.||5.83|-6.05|
71803750|NCT02819726|143106480|OTHER||Difference (%)|1.3|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|95.0|-12.59|15.1||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||15.10|-12.59|
71803751|NCT02819726|143106480|OTHER||Difference (%)|0.2|STANDARD_ERROR_OF_MEAN|7.21|||TWO_SIDED|95.0|-13.75|14.03|||Difference (%)|||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||14.03|-13.75|
71803752|NCT02819726|143106480|OTHER||Difference (%)|-1.1|STANDARD_ERROR_OF_MEAN|7.29|||TWO_SIDED|95.0|-15.14|12.91||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.||12.91|-15.14|
71803753|NCT02819726|143106486|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|22.1|||||TWO_SIDED|90.0|-137.1|181.3||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||181.3|-137.1|
71803754|NCT02819726|143106486|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|69.5|||||TWO_SIDED|90.0|-91.8|230.8||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||230.8|-91.8|
71803755|NCT02819726|143106486|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 \[AUEC(0-d15)\]|Statistical Comparisons Difference|47.4|||||TWO_SIDED|90.0|-112.5|207.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||207.2|-112.5|
71894198|NCT01982630|143310401|OTHER||Difference of Least Squares Means|9.61|||||TWO_SIDED|90.0|4.42|14.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||14.81|4.42|
71803756|NCT02819726|143106486|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|310.7|||||TWO_SIDED|90.0|-187.9|809.4||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||809.4|-187.9|
71841381|NCT03676192|143192224|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.1||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.10|0.77|
71841382|NCT03676192|143192225|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.77|1.19||||||Adjusted stratified Cox regression model is used to estimate the hazard ratio and its 95% CI for receiving CT-P16 compared with receiving EU-approved Avastin using region (EMEA vs. America vs. Asia), sex (female vs. male), disease status at baseline (recurrence vs. metastatic), and ECOG performance score at baseline (0 vs. 1) as stratification factors.||1.19|0.77|
71841383|NCT03916276|143192228|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
71841384|NCT03916276|143192229|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841385|NCT03916276|143192230|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841386|NCT03916276|143192231|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841387|NCT03916276|143192232|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841388|NCT03916276|143192233|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841389|NCT03916276|143192234|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71894199|NCT01982630|143310401|OTHER||Difference of Least Squares Means|7.15|||||TWO_SIDED|90.0|1.7|12.6|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline TWA0-24hr of heart rate as a covariate||||12.60|1.70|
71803757|NCT02819726|143106486|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|296.1|||||TWO_SIDED|90.0|-213.8|806.1||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||806.1|-213.8|
71803758|NCT02819726|143106486|OTHER|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week \[AUEC(0-w24)\]|Statistical Comparisons Difference|-14.6|||||TWO_SIDED|90.0|-527.4|498.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.||498.2|-527.4|
71841390|NCT03916276|143192235|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841391|NCT03916276|143192236|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841392|NCT03916276|143192237|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||<|0.05|||||||ANOVA|||||||<.05
71841393|NCT03916276|143192238|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
71841394|NCT03916276|143192239|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements|||||>|0.05|||||||ANOVA|||||||>.05
71841395|NCT03916276|143192240|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841396|NCT03916276|143192241|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841397|NCT03916276|143192242|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841398|NCT03916276|143192243|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841399|NCT03916276|143192244|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71894200|NCT01982630|143310402|OTHER||Difference of Least Squares Means|-3.97|||||TWO_SIDED|90.0|-6.8|-1.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||-1.14|-6.80|
71803759|NCT00795600|143106549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.645|STANDARD_ERROR_OF_MEAN|3.364||0.849||95.0|-7.404|6.114||H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.114|-7.404|0.849
71803760|NCT00795600|143106550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|3.478||0.948||95.0|-7.588|6.407||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||6.407|-7.588|0.948
71803761|NCT00795600|143106551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.36|STANDARD_ERROR_OF_MEAN|498.7||0.696||95.0|-805.8|1198.5||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1198.5|-805.8|0.696
71803762|NCT00795600|143106552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|192.81|STANDARD_ERROR_OF_MEAN|515.4||0.71||95.0|-844.0|1229.7||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.||1229.7|-844.0|0.710
71803763|NCT00795600|143106553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|288.21|STANDARD_ERROR_OF_MEAN|766.41||0.709||95.0|-1252.0|1828.4|||ANCOVA|||||1828.4|-1252.0|0.709
71803764|NCT00795600|143106554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|2.732||0.948||95.0|-5.668|5.313|||ANCOVA|||||5.313|-5.668|0.948
71803765|NCT00795600|143106555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1151.0|STANDARD_ERROR_OF_MEAN|810.48||0.162||95.0|-2780.0|477.33|||ANCOVA|||||477.33|-2780.0|0.162
71803766|NCT00795600|143106556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.747|STANDARD_ERROR_OF_MEAN|1.788||0.131||95.0|-6.34|0.846|||ANCOVA|||||0.846|-6.340|0.131
71803767|NCT00795600|143106557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.4|STANDARD_ERROR_OF_MEAN|368.69||0.766||95.0|-851.3|630.51|||ANCOVA|||||630.51|-851.3|0.766
71894201|NCT01982630|143310402|OTHER||Difference of Least Squares Means|-0.7|||||TWO_SIDED|90.0|-4.33|2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.93|-4.33|
71803768|NCT00795600|143106558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|1.662||0.716||95.0|-3.949|2.729|||ANCOVA|||||2.729|-3.949|0.716
71803769|NCT00795600|143106559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.491|STANDARD_ERROR_OF_MEAN|0.695||0.483||95.0|-0.906|1.888|||ANCOVA|||||1.888|-0.906|0.483
71803770|NCT00795600|143106560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|1.909||0.952||95.0|-3.721|3.953|||ANCOVA|||||3.953|-3.721|0.952
71803771|NCT00795600|143106561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.278|STANDARD_ERROR_OF_MEAN|0.746||0.711||95.0|-1.778|1.221|||ANCOVA|||||1.221|-1.778|0.711
71803772|NCT00795600|143106562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.585|STANDARD_ERROR_OF_MEAN|1.854||0.397||95.0|-5.31|2.141|||ANCOVA|||||2.141|-5.310|0.397
71803773|NCT00795600|143106563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.916|STANDARD_ERROR_OF_MEAN|10.985||0.421||95.0|-30.99|13.159|||ANCOVA|||||13.159|-30.99|0.421
71803774|NCT00795600|143106564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.061|STANDARD_ERROR_OF_MEAN|6.216||0.42||95.0|-17.55|7.43|||ANCOVA|||||7.430|-17.55|0.420
71803775|NCT00795600|143106565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.961|STANDARD_ERROR_OF_MEAN|13.007||0.705||95.0|-31.1|21.178|||ANCOVA|||||21.178|-31.10|0.705
71803776|NCT00795600|143106566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|STANDARD_ERROR_OF_MEAN|4.776||0.341||95.0|-14.19|5.007|||ANCOVA|||||5.007|-14.19|0.341
71803777|NCT00795600|143106567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.034||0.902||95.0|-0.064|0.073|||ANCOVA|||||0.073|-0.064|0.902
71803778|NCT00795600|143106568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|3.85||0.839||95.0|-8.525|6.947|||ANCOVA|||||6.947|-8.525|0.839
71803779|NCT00795600|143106569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.041||0.607||95.0|-0.105|0.062|||ANCOVA|||||0.062|-0.105|0.607
71803780|NCT00795600|143106570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.777|STANDARD_ERROR_OF_MEAN|3.719||0.635||95.0|-9.254|5.7|||ANCOVA|||||5.700|-9.254|0.635
71803781|NCT00795600|143106571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.628||95.0|-0.663|0.403|||ANCOVA|||||0.403|-0.663|0.628
71803782|NCT00795600|143106572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.92|STANDARD_ERROR_OF_MEAN|17.46||0.535||95.0|-46.03|24.182|||ANCOVA|||||24.182|-46.03|0.535
71803783|NCT00795600|143106573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.918|STANDARD_ERROR_OF_MEAN|4.332||0.66||95.0|-10.65|6.813|||ANCOVA|||||6.813|-10.65|0.660
71803784|NCT00795600|143106600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.629|STANDARD_ERROR_OF_MEAN|0.967||0.518||95.0|-2.572|1.313|||ANCOVA|||||1.313|-2.572|0.518
71803785|NCT00795600|143106601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.546|STANDARD_ERROR_OF_MEAN|1.283||0.673||95.0|-3.123|2.032|||ANCOVA|||||2.032|-3.123|0.673
71803786|NCT00795600|143106602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.466|STANDARD_ERROR_OF_MEAN|1.386||0.738||95.0|-2.319|3.25|||ANCOVA|||||3.250|-2.319|0.738
71803787|NCT00795600|143106603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.062|STANDARD_ERROR_OF_MEAN|2.168||0.346||95.0|-2.3|6.423|||ANCOVA|||||6.423|-2.300|0.346
71803788|NCT00795600|143106604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|STANDARD_ERROR_OF_MEAN|6.173||0.781||95.0|-10.71|14.167|||ANCOVA|||||14.167|-10.71|0.781
71803789|NCT02334800|143106646|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|73.6|||||TWO_SIDED|90.0|57.81|93.71||||||||93.71|57.81|
71803790|NCT02334800|143106646|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.3|||||TWO_SIDED|90.0|90.57|146.79||||||||146.79|90.57|
71803791|NCT02334800|143106646|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|133.68|||||TWO_SIDED|90.0|105.0|170.19||||||||170.19|105.00|
71803792|NCT02334800|143106647|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|94.99|||||TWO_SIDED|90.0|69.93|129.03||||||||129.03|69.93|
71803793|NCT02334800|143106647|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|117.75|||||TWO_SIDED|90.0|86.69|159.95||||||||159.95|86.69|
71803794|NCT02334800|143106647|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|129.89|||||TWO_SIDED|90.0|95.63|176.43||||||||176.43|95.63|
71803795|NCT02334800|143106648|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|83.01|||||TWO_SIDED|90.0|65.37|105.43||||||||105.43|65.37|
71803796|NCT02334800|143106648|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.28|||||TWO_SIDED|90.0|105.73|170.53||||||||170.53|105.73|
71803797|NCT02334800|143106648|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|176.88|||||TWO_SIDED|90.0|139.28|224.63||||||||224.63|139.28|
71803798|NCT02334800|143106649|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|72.81|||||TWO_SIDED|90.0|56.43|93.93||||||||93.93|56.43|
71803799|NCT02334800|143106649|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|115.57|||||TWO_SIDED|90.0|89.58|149.11||||||||149.11|89.58|
71803800|NCT02334800|143106649|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.66|||||TWO_SIDED|90.0|104.38|173.73||||||||173.73|104.38|
71803801|NCT02334800|143106650|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|82.14|||||TWO_SIDED|90.0|63.83|105.71||||||||105.71|63.83|
71803802|NCT02334800|143106650|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|134.9|||||TWO_SIDED|90.0|104.82|173.6||||||||173.60|104.82|
71803803|NCT02334800|143106650|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|178.39|||||TWO_SIDED|90.0|138.62|229.57||||||||229.57|138.62|
71803804|NCT02334800|143106653|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|107.37|||||TWO_SIDED|90.0|78.06|147.68||||||||147.68|78.06|
71803805|NCT02334800|143106653|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|137.5|||||TWO_SIDED|90.0|99.96|189.12||||||||189.12|99.96|
71803806|NCT02334800|143106653|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|172.27|||||TWO_SIDED|90.0|125.25|236.96||||||||236.96|125.25|
71803807|NCT00801684|143106672|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The difference between the active treatment was compared to placebo. For a null hypothesis, the difference would equal 0 (zero).||||<0.0001
71803808|NCT01255358|143106684|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-4.0|STANDARD_DEVIATION|7.5||0.02|TWO_SIDED|95.0|-7.1|-0.9|||Wilcoxon (Mann-Whitney)|||The primary analysis on ICARS Total score has been conducted on the ITT Population employing carry-forward and carry-backward procedures for missing data imputation, in order to evaluate all enrolled patients.||-0.9|-7.1|0.02
71803809|NCT01255358|143106685|OTHER|Changes from baseline (V1) at V2, V4 and V7 were analyzed with a RMANOVA design with age and ICARS at baseline as covariates. A Wilcoxon non-parametric test between visits was performed when the overall analysis was significant in order to help determine timing of effects|Mean Difference (Final Values)|-5.2|STANDARD_DEVIATION|7.0||0.0031|TWO_SIDED|95.0|-8.4|-2.0|||Wilcoxon (Mann-Whitney)|||Overall analysis on the PP Population||-2|-8.4|0.0031
71803810|NCT01255358|143106690|OTHER|VABS Total score and subscales have been analyzed with a RMANOVA design, using age as covariate (dichotomized as Low- or High-, using median age as threshold).|Median Difference (Final Values)|1.3|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)|||VABS total score at V7||1.8|0.8|<0.0001
71841400|NCT04778397|143192253|SUPERIORITY||Stratified Hazard Ratio|1.132||||0.507|TWO_SIDED|95.0|0.783|1.637|||Stratified log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.637|0.783|0.5070
71841401|NCT04778397|143192254|SUPERIORITY||Stratified Hazard Ratio|1.183||||0.3237|TWO_SIDED|95.0|0.845|1.654|||Stratified Log-rank test|P-value from stratified log-rank test.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors (appropriateness for non-intensive therapy vs intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites)).|1.654|0.845|0.3237
71803811|NCT01255358|143106691|OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.1|<|0.0001|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|1|<0.0001
71803812|NCT04788147|143106709|OTHER|"The modified 3+3 design with 6 patients at the 'Recommended RefleXion FDG Dose level' aims to ensure that the observed proportion of patients below activity threshold to be less than 33%.~Probability of Observations at Most 1 of 6 below Activity Threshold True below activity rate 40% 30% 20% 10% Probability at most 1 of 6 patients below activity threshold 0.233 0.420 0.655 0.886"||||||||||||||||"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|"Statistical analysis of the primary endpoint is not applicable to Cohort I. A modified 3+3 design was utilized wherein meeting the activity level threshold, not dose-limiting toxicity, is the endpoint. The RRFD is primarily based upon the lower FDG dose level where 5 to 6 out of 6 subjects have an Activity Concentration greater than 5 kBq/ml."|||
71803813|NCT05101252|143106726|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.00 logMAR for distance.|Least-square Mean|-0.08|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.14|-0.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 22 subjects were required to test for superiority for distance.||-0.01|-0.14|
71894202|NCT01982630|143310402|OTHER||Difference of Least Squares Means|3.26|||||TWO_SIDED|90.0|-0.54|7.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.06|-0.54|
71675308|NCT01908829|142868074|SUPERIORITY||LS Means|2.31|STANDARD_ERROR_OF_MEAN|0.89|=|0.01|TWO_SIDED|95.0|0.56|4.06||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.06|0.56|=0.010
71675309|NCT01908829|142868074|SUPERIORITY||LS Means|3.49|STANDARD_ERROR_OF_MEAN|0.94|<|0.001|TWO_SIDED|95.0|1.65|5.33||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.33|1.65|<0.001
71675310|NCT01908829|142868074|SUPERIORITY||LS Means|3.15|STANDARD_ERROR_OF_MEAN|0.92|=|0.001|TWO_SIDED|95.0|1.35|4.95||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.95|1.35|=0.001
71894203|NCT01982630|143310403|OTHER||Difference of Least Squares Means|-1.58|||||TWO_SIDED|90.0|-5.31|2.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||2.15|-5.31|
71803814|NCT05101252|143106726|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for intermediate.|Least-square Mean|0.0|STANDARD_ERROR_OF_MEAN|0.022|||TWO_SIDED|98.75|-0.06|0.07|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 12 subjects were required to test for superiority for intermediate.||0.07|-0.06|
71803815|NCT05101252|143106726|SUPERIORITY|Superiority was declared if the upper limit of the 98.75% confidence interval of was below 0.17 logMAR for near.|Least-square Mean|0.09|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|98.75|0.02|0.16|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 90% statistical power, that 60 subjects were required to test for superiority for near.||0.16|0.02|
71803816|NCT05101252|143106727|SUPERIORITY|Superiority was declared if the lower bound of the 98.75% confidence interval was above 32.|Least-square Mean|50.8|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|98.75|43.1|58.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1.25% individually) with at least 99% statistical power, that 13 subjects were required to test for superiority for CLUE vision scores.||58.5|43.1|
71803817|NCT05101252|143106728|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the least-square mean difference was below 0.05 logMAR.|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|-0.05|0.05|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Test minus Control|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 95% statistical power, that 60 subjects were required to test for non-inferiority of the Test compared to the Control for distance (4m).||0.05|-0.05|
71803818|NCT02401672|143106729|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71803819|NCT02401672|143106730|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71803820|NCT02401672|143106731|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71803821|NCT02401672|143106732|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71803822|NCT03321019|143106757|OTHER||F-statistic|8.59|||<|0.0001|TWO_SIDED|||||The p value was adjusted for multiple comparisons using Tukey's method.|ANOVA|Degree of freedom - 3, 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||<.0001
71803823|NCT03321019|143106758|OTHER||F-statistic|0.44||||0.72|TWO_SIDED|||||Tukey's method was used to control for multiple comparisons.|ANOVA|Degrees of freedom - 3. 278||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.72
71803824|NCT03321019|143106759|OTHER||F-statistic|3.048||||0.02|TWO_SIDED|||||Dunnett's T3 method was used to account for multiple comparisons.|ANOVA|degrees of freedom: 3, 229||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.02
71803825|NCT03321019|143106760|OTHER||F-statistic|2.939||||0.034|TWO_SIDED|||||The p value was adjusted in the analysis for multiple comparisons using Tukey's method.|ANOVA|Degrees of freedom - 3, 231||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.034
71803826|NCT03321019|143106761|OTHER||F-statistic|1.494||||0.022|TWO_SIDED|||||Tukey's method was used to adjust for multiple comparisons.|ANOVA|Degrees of freedom - 3, 274||Healthy controls were compared to PD participants across each of the 3 visits. PD participants were compared between visits 1, 2 and 3.||||0.022
71803827|NCT04289753|143106780|SUPERIORITY||Odds Ratio (OR)|0.56|||||TWO_SIDED|95.0|0.46|0.69||||||||0.69|0.46|
71803828|NCT04289753|143106781|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
71803829|NCT04289753|143106782|SUPERIORITY||Odds Ratio (OR)|0.85|||||TWO_SIDED|95.0|0.7|1.0||||||||1.0|0.70|
71803830|NCT05799495|143106820|OTHER||LS Mean difference|-0.671|STANDARD_ERROR_OF_MEAN|0.3178||0.0181|TWO_SIDED|80.0|-1.08|-0.262|||Mixed Models Analysis|||||-0.262|-1.080|0.0181
71894204|NCT01982630|143310403|OTHER||Difference of Least Squares Means|2.52|||||TWO_SIDED|90.0|-2.32|7.35|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.35|-2.32|
71803831|NCT05799495|143106820|OTHER||LS Mean difference|-0.802|STANDARD_ERROR_OF_MEAN|0.3562||0.0127|TWO_SIDED|80.0|-1.26|-0.344|||Mixed Models Analysis|||||-0.344|-1.260|0.0127
71803832|NCT05799495|143106820|OTHER||LS Mean difference|-1.167|STANDARD_ERROR_OF_MEAN|0.264|<|0.0001|TWO_SIDED|80.0|-1.506|-0.827|||Mixed Models Analysis|||||-0.827|-1.506|<.0001
71803833|NCT05799495|143106821|OTHER||LS Mean difference|-0.608|STANDARD_ERROR_OF_MEAN|0.3402||0.0378|TWO_SIDED|80.0|-1.046|-0.17|||Mixed Models Analysis|||Day 3||-0.170|-1.046|0.0378
71803834|NCT05799495|143106821|OTHER||LS Mean difference|-1.304|STANDARD_ERROR_OF_MEAN|0.3718||0.0003|TWO_SIDED|80.0|-1.782|-0.826|||Mixed Models Analysis|||Day 3||-0.826|-1.782|0.0003
71803835|NCT05799495|143106821|OTHER||LS Mean difference|-1.148|STANDARD_ERROR_OF_MEAN|0.2803|<|0.0001|TWO_SIDED|80.0|-1.509|-0.788|||Mixed Models Analysis|||Day 3||-0.788|-1.509|<.0001
71803836|NCT05799495|143106821|OTHER||LS Mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.2732||0.5931|TWO_SIDED|80.0|-0.287|0.416|||Mixed Models Analysis|||Day 10||0.416|-0.287|0.5931
71803837|NCT05799495|143106821|OTHER||LS Mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.2914||0.508|TWO_SIDED|80.0|-0.369|0.381|||Mixed Models Analysis|||Day 10||0.381|-0.369|0.5080
71803838|NCT05799495|143106821|OTHER||LS Mean difference|-0.214|STANDARD_ERROR_OF_MEAN|0.223||0.1692|TWO_SIDED|80.0|-0.501|0.073|||Mixed Models Analysis|||Day 10||0.073|-0.501|0.1692
71803839|NCT05799495|143106821|OTHER||LS Mean difference|-0.239|STANDARD_ERROR_OF_MEAN|0.2004||0.1172|TWO_SIDED|80.0|-0.497|0.019|||Mixed Models Analysis|||Day 14||0.019|-0.497|0.1172
71803840|NCT05799495|143106821|OTHER||LS Mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.2178||0.3979|TWO_SIDED|80.0|-0.337|0.224|||Mixed Models Analysis|||Day 14||0.224|-0.337|0.3979
71803841|NCT05799495|143106821|OTHER||LS Mean difference|-0.383|STANDARD_ERROR_OF_MEAN|0.1655||0.0109|TWO_SIDED|80.0|-0.595|-0.17|||Mixed Models Analysis|||Day 14||-0.170|-0.595|0.0109
71803842|NCT04102501|143106861|SUPERIORITY|||||||0.5858|||||||Mixed Models Analysis|||||||0.5858
71803843|NCT04102501|143106862|SUPERIORITY|||||||0.8061|||||||Mixed Models Analysis|||||||0.8061
71803844|NCT00439777|143106904|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events will give a power of 90% to demonstrate that rivaroxaban is at least as effective as the comparator, considering a relative non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided alpha=0.05). The mean overall incidence for the primary efficacy outcome of 3% was expected and therefore 1465 patients per group would be needed. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|1.12|STANDARD_ERROR_OF_MEAN|0.2067||0.0026|TWO_SIDED|95.0|0.75|1.68|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.68|0.75|0.0026
71803845|NCT00439777|143106905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.15||0.33|TWO_SIDED|95.0|0.86|1.56||Nominal p-value|Regression, Cox||The standard error of the log hazard ratio was estimated.|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.||1.56|0.86|0.33
71803846|NCT00439777|143106906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.1499||0.275|TWO_SIDED|95.0|0.63|1.14||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|||1.14|0.63|0.275
71803847|NCT00439777|143106907|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|STANDARD_ERROR_OF_MEAN|0.257||0.55|TWO_SIDED|95.0|0.7|1.93||nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.93|0.70|0.55
71803848|NCT00439777|143106908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|STANDARD_ERROR_OF_MEAN|0.3289||0.85|TWO_SIDED|95.0|0.49|1.79||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.79|0.49|0.85
71803849|NCT00439777|143106909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|STANDARD_ERROR_OF_MEAN|0.08756||0.23|TWO_SIDED|95.0|0.76|1.07||If the primary efficacy analysis shows that rivaroxaban is non-inferior to the comparator, the principal safety outcome was to be compared between treatment groups to maintain the overall type I error of 0.05 (2-sided) (a closed testing procedure).|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.07|0.76|0.23
71803850|NCT03855189|143106937|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803851|NCT03855189|143106937|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||<0.01
71803852|NCT03855189|143106937|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.||||0.06
71803853|NCT03855189|143106938|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
71803854|NCT03855189|143106938|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803855|NCT03855189|143106938|OTHER|||||||0.5|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.50
71803856|NCT03855189|143106941|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803857|NCT03855189|143106941|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803858|NCT03855189|143106941|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
71803859|NCT03855189|143106942|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
71803860|NCT03855189|143106942|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803861|NCT03855189|143106942|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
71803862|NCT03855189|143106943|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
71803863|NCT03855189|143106943|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
71803864|NCT03855189|143106943|OTHER|||||||0.81|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.81
71894205|NCT01982630|143310403|OTHER||Difference of Least Squares Means|4.1|||||TWO_SIDED|90.0|-0.96|9.16|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.16|-0.96|
71894206|NCT01982630|143310404|OTHER||Difference of Least Squares Means|-3.48|||||TWO_SIDED|90.0|-7.31|0.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||0.34|-7.31|
71803865|NCT03855189|143106944|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
71803866|NCT03855189|143106944|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803867|NCT03855189|143106944|OTHER|||||||0.17|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.17
71803868|NCT03855189|143106945|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803869|NCT03855189|143106945|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
71803870|NCT03855189|143106945|OTHER|||||||0.39|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.39
71803871|NCT03855189|143106946|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803872|NCT03855189|143106946|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803873|NCT03855189|143106946|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
71803874|NCT03855189|143106947|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
71803875|NCT03855189|143106947|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803876|NCT03855189|143106947|OTHER|||||||0.54|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.54
71803877|NCT03855189|143106948|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803878|NCT03855189|143106948|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803879|NCT03855189|143106948|OTHER|||||||0.71|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.71
71803880|NCT03855189|143106949|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803881|NCT03855189|143106949|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803882|NCT03855189|143106949|OTHER|||||||0.77|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.77
71803883|NCT03855189|143106950|OTHER|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.11
71803884|NCT03855189|143106950|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
71803885|NCT03855189|143106950|OTHER|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.60
71803886|NCT03855189|143106951|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803887|NCT03855189|143106951|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803888|NCT03855189|143106951|OTHER|||||||0.59|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.59
71803889|NCT03855189|143106952|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
71803890|NCT03855189|143106952|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803891|NCT03855189|143106952|OTHER|||||||0.43|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.43
71803892|NCT03855189|143106953|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
71803893|NCT03855189|143106953|OTHER|||||||0.08|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.08
71803894|NCT03855189|143106953|OTHER|||||||0.96|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.96
71803895|NCT03855189|143106954|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803896|NCT03855189|143106954|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803897|NCT03855189|143106954|OTHER|||||||0.64|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.64
71803898|NCT03855189|143106955|OTHER|||||||0.25|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.25
71803899|NCT03855189|143106955|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
71803900|NCT03855189|143106955|OTHER|||||||0.26|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.26
71803901|NCT03855189|143106956|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803902|NCT03855189|143106956|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803903|NCT03855189|143106956|OTHER|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.09
71803904|NCT03855189|143106957|OTHER|||||||0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.05
71803905|NCT03855189|143106957|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71841402|NCT04778397|143192255|SUPERIORITY||Stratified Hazard Ratio|1.389||||0.0661|TWO_SIDED|95.0|1.043|1.848|||Stratified Log-rank test|P-value for comparing the event free survival functions from the two treatment groups was from stratified log-rank test, adjusted for randomization.|||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors: therapy appropriateness, age (\< 75 years, \>=75 years), geographic region (US sites, outside the US sites).|1.848|1.043|0.0661
71841403|NCT04778397|143192256|SUPERIORITY||Stratified Odds Ratio|0.25|||||TWO_SIDED|95.0|0.123|0.506|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.506|0.123|
71841404|NCT04778397|143192257|SUPERIORITY||Stratified Odds Ratio|0.072|||||TWO_SIDED|95.0|0.009|0.559|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.559|0.009|
71894207|NCT01982630|143310404|OTHER||Difference of Least Squares Means|3.96|||||TWO_SIDED|90.0|-1.11|9.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||9.03|-1.11|
71894208|NCT01982630|143310404|OTHER||Difference of Least Squares Means|7.44|||||TWO_SIDED|90.0|2.16|12.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||12.73|2.16|
71894209|NCT01982630|143310405|OTHER||Difference of Least Squares Means|0.03|||||TWO_SIDED|90.0|-4.51|4.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||4.57|-4.51|
71803906|NCT03855189|143106957|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
71803907|NCT03855189|143106958|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
71803908|NCT03855189|143106958|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803909|NCT03855189|143106958|OTHER|||||||0.53|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.53
71803910|NCT03855189|143106959|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
71803911|NCT03855189|143106959|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803912|NCT03855189|143106959|OTHER|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.02
71803913|NCT03855189|143106960|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
71803914|NCT03855189|143106960|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803915|NCT03855189|143106960|OTHER|||||||0.34|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.34
71803916|NCT03855189|143106961|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803917|NCT03855189|143106961|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71841405|NCT04778397|143192258|SUPERIORITY||Stratified Odds Ratio|0.215|||||TWO_SIDED|95.0|0.108|0.428|||||||Odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for randomization stratification factors (appropriateness for non-intensive therapy versus intensive therapy, age (\< 75 years, \>=75 years), geographic region (US sites, outside US sites)).|0.428|0.108|
71841406|NCT02668692|143192288|SUPERIORITY||Odds Ratio (OR)|1.96|||=|0.68|TWO_SIDED|95.0|0.35|10.95|||Fisher Exact|||Statistical analysis of the FAS.||10.95|0.35|=0.68
71841407|NCT02668692|143192288|SUPERIORITY||Odds Ratio (OR)|1.92|||=|0.68|TWO_SIDED|95.0|0.34|10.72||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||10.72|0.34|=0.68
71841408|NCT02668692|143192289|SUPERIORITY||Odds Ratio (OR)|0.28|||=|0.009|TWO_SIDED|95.0|0.11|0.74|||Fisher Exact|||Statistical analysis for the FAS.||0.74|0.11|=0.009
71841409|NCT02668692|143192289|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.003|TWO_SIDED|95.0|0.08|0.63||Treatment comparison by Fisher's exact test.|Fisher Exact||Odds of 'overall improvement' in LEO 80185 gel group relative to Dovobet® ointment group.|Statistical analysis of the PPAS.||0.63|0.08|=0.003
71841410|NCT01627574|143192302|SUPERIORITY||Risk Ratio, log|0.281|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|95.0|0.056|1.42|||Chi-squared, Corrected|||||1.42|.056|>.05
71894210|NCT01982630|143310405|OTHER||Difference of Least Squares Means|4.7|||||TWO_SIDED|90.0|-1.33|10.73|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||10.73|-1.33|
71803918|NCT03855189|143106961|OTHER|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.04
71803919|NCT03855189|143106962|OTHER|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.06
71803920|NCT03855189|143106962|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803921|NCT03855189|143106962|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
71803922|NCT03855189|143106963|OTHER|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.13
71675311|NCT01908829|142868075|SUPERIORITY||LS Means|2.9|STANDARD_ERROR_OF_MEAN|0.96|=|0.003|TWO_SIDED|95.0|1.02|4.78||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.78|1.02|=0.003
71675312|NCT01908829|142868075|SUPERIORITY||LS Means|3.35|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.29|5.4||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.40|1.29|=0.001
71803923|NCT03855189|143106963|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803924|NCT03855189|143106963|OTHER|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.07
71803925|NCT03855189|143106964|OTHER|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.03
71803926|NCT03855189|143106964|OTHER||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||<0.01
71803927|NCT03855189|143106964|OTHER|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).||||0.01
71803928|NCT03238001|143106985|NON_INFERIORITY|In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.|Lower 90% CL for difference in Kappas|-0.12|||||TWO_SIDED|90.0|-0.12|0.05|||||90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).|A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.||0.05|-0.12|
71803929|NCT02207829|143107007|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.|Mean Difference (Final Values)|0.059|||<|0.001|TWO_SIDED|95.0|0.029|0.088|||Mixed Models Analysis|||||0.088|0.029|<0.001
71803930|NCT03191903|143107010|SUPERIORITY|||||||0.5874|||||||ANOVA|||||||0.5874
71803931|NCT03191903|143107011|SUPERIORITY|||||||0.0829|||||||ANOVA|||||||0.0829
71803932|NCT03191903|143107012|SUPERIORITY|||||||0.4673|||||||ANOVA|||||||0.4673
71803933|NCT03191903|143107013|SUPERIORITY|||||||0.9408|||||||ANOVA|||||||0.9408
71803934|NCT03191903|143107014|SUPERIORITY|||||||0.777|||||||ANOVA|||||||0.7770
71803935|NCT03191903|143107015|SUPERIORITY|||||||0.759|||||||ANOVA|||||||0.7590
71803936|NCT03191903|143107016|SUPERIORITY|||||||0.8309|||||||ANOVA|||||||0.8309
71803937|NCT03191903|143107017|SUPERIORITY|||||||0.6215|||||||ANOVA|||||||0.6215
71803938|NCT03191903|143107018|SUPERIORITY|||||||0.216|||||||ANOVA|||||||0.2160
71803939|NCT03191903|143107019|SUPERIORITY|||||||0.7026|||||||ANOVA|||||||0.7026
71803940|NCT03191903|143107020|SUPERIORITY|||||||0.0438|||||||ANOVA|||||||0.0438
71803941|NCT04369469|143107028|OTHER||Risk Difference (RD)|-0.0205||||0.6059|TWO_SIDED|95.0|-0.1703|0.1293||One-sided Mantel-Haenszel test of the difference in two proportions stratified by intubated or not intubated on Day 1 and a family-wise Type I error of 0.025.|Mantel Haenszel||Two-sided 95% confidence interval using the Sato variance estimator, combined overall imputations.|||0.1293|-0.1703|0.6059
71803942|NCT01802411|143107046|SUPERIORITY||LSMD|13.1||||0.5598|TWO_SIDED|95.0|-31.0|57.0|||ANCOVA|||||57|-31|0.5598
71803943|NCT00822510|143107103|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<.05
71803944|NCT00822510|143107105|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED|0.79|||||ANOVA|||||||.79
71803945|NCT00822510|143107106|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
71803946|NCT00822510|143107107|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|0.001|||||ANOVA|||||||.001
71803947|NCT00822510|143107108|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|0.71|||||ANOVA|||||||.71
71803948|NCT00822510|143107109|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|0.01|||||ANOVA|||||||.01
71803949|NCT01404312|143107110|NON_INFERIORITY|"Non-inferiority margin: 1.25 events per 100 person-years.~Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power."|Incidence Rate Difference|-0.0231|||||TWO_SIDED|95.1|-0.346|0.3|||||"Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).~Incidence rate units: Events per 100 person-years"|Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.||0.300|-0.346|
71803950|NCT01404312|143107111|SUPERIORITY||Risk Difference (RD)|-0.016||||0.073|TWO_SIDED|95.0|-0.035|0.002||Not adjusted for multiple comparisons.|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any SAE occurrence between arms A and B.~H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B."||0.002|-0.035|0.073
71803951|NCT01404312|143107112|SUPERIORITY||Risk Difference (RD)|-0.0058||||0.405|TWO_SIDED|95.0|-0.019|0.007||Not adjusted for multiple comparisons|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.~H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B."||0.007|-0.019|0.405
71841411|NCT05233800|143192311|SUPERIORITY||Mean Difference (Net)|5.83|||<|0.05|TWO_SIDED|95.0|3.84|7.81|||Mixed Models Analysis|||||7.81|3.84|<0.05
71841412|NCT04707469|143192322|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.27||||0.0006|TWO_SIDED|95.0|-0.42|-0.12||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.12|-0.42|0.0006
71894211|NCT01982630|143310405|OTHER||Difference of Least Squares Means|4.66|||||TWO_SIDED|90.0|-1.67|11.0|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.00|-1.67|
71803952|NCT01404312|143107113|SUPERIORITY||Odds Ratio (OR)|2.093|||||TWO_SIDED|95.0|1.315|3.332|||||"Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A~Not adjusted for multiple comparisons."|"Odds ratio of being in higher category estimated from proportional odds model~H0: Odds ratio of being in higher category for Arm A vs Arm B = 1"||3.332|1.315|
71803953|NCT01404312|143107114|SUPERIORITY|||||||0.3078||||||Not adjusted for multiple comparisons|Log Rank|||H0: Survival curve Arm A = Survival curve Arm B||||0.3078
71803954|NCT01404312|143107115|SUPERIORITY||Hazard Ratio (HR)|1.396||||0.2802|TWO_SIDED|95.0|0.762|2.559||Not adjusted for multiple comparisons|Hazard Ratio||Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR \> 1 favors arm A|"Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.~H0: Hazard Ratio for Arm A vs Arm B = 1"||2.559|0.762|0.2802
71803955|NCT04419493|143107121|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|102.2|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.87|110.1|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.10|94.87|
71803956|NCT04419493|143107123|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%|Geometric Least Squares Mean ratio (%)|105.81|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|92.83|99.18|112.88|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||112.88|99.18|
71803957|NCT04419493|143107125|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00% .|Geometric Least Squares Mean ratio (%)|102.17|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|92.83|94.79|110.12|||||Geometric Least Squares Mean ratio is: Alteplase, TPA-02/Alteplase, TPA-05. Standard Error of the mean is actually the intra-individual geometric coefficient variation.|"The null hypothesis was that the ratio of expected geometric least squares means Alteplase, TPA-02 vs. Alteplase, TPA-05 is less than 80.00% or more than 125.00%.~The statistical model used for the analysis of this endpoints was an analysis of variance (ANOVA) model on the logarithmic scale.~This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. All effects were considered as fixed."||110.12|94.79|
71803958|NCT03794089|143107130|SUPERIORITY|||||||0.035||||||a priori threshold for statistical significance was p\<=.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline GAD-7 total scores||||0.035
71803959|NCT03794089|143107131|SUPERIORITY|||||||0.231||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline PHQ-9 total scores||||0.231
71803960|NCT03794089|143107132|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.393||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 4 weeks||||0.393
71803961|NCT03794089|143107132|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 8 weeks||||0.022
71841413|NCT04707469|143192322|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model with treatment, strata and region as categorical fixed effects and baseline value as covariate for each of the 1000 imputed complete datasets,and pooled by Rubin's rule to draw inference.|Treatment difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.38||Unadjusted two-sided p-value for test of no difference.|ANCOVA|||Treatment policy estimand||-0.38|-0.68|<.0001
71841414|NCT04685135|143192416|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.76|||Log Rank|HR and CI are from stratified Cox proportional hazard model||||0.76|0.45|<0.0001
71841415|NCT04685135|143192418|SUPERIORITY||Odds Ratio (OR)|4.68|||<|0.0001|TWO_SIDED|95.0|2.56|8.56|||Cochran Mantel Haenszel chi-square test|||||8.56|2.56|<0.0001
71841416|NCT04911296|143192449|OTHER|||||||0.935|||||||Fisher Exact|||||||0.935
71841417|NCT04911296|143192450|OTHER|||||||0.536|||||||Fisher Exact|||||||0.536
71841418|NCT03295721|143192531|SUPERIORITY||Least Squares Mean Difference (LSMD)|-122.05|STANDARD_ERROR_OF_MEAN|21.217|<|0.0001|TWO_SIDED|95.0|-163.76|-80.34|||ANOVA|||||-80.34|-163.76|< 0.0001
71841419|NCT03295721|143192532|SUPERIORITY||Least Squares Mean Difference (LSMD)|-70.16|STANDARD_ERROR_OF_MEAN|18.777|=|0.0002|TWO_SIDED|95.0|-107.07|-33.25|||ANOVA|||||-33.25|-107.07|= 0.0002
71841420|NCT03295721|143192533|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71675313|NCT01908829|142868075|SUPERIORITY||LS Means|4.71|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|2.55|6.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.87|2.55|<0.001
71675314|NCT01908829|142868075|SUPERIORITY||LS Means|4.29|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|2.2|6.39||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||6.39|2.20|<0.001
71675315|NCT01908829|142868076|SUPERIORITY||LS Means|1.94|STANDARD_ERROR_OF_MEAN|0.96|=|0.044|TWO_SIDED|95.0|0.05|3.83||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.83|0.05|=0.044
71803962|NCT03794089|143107132|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.013||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to 12 weeks||||0.013
71803963|NCT03794089|143107132|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.049||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Anxiety subscale total from Baseline to Post assessment (16 weeks)||||0.049
71803964|NCT03794089|143107133|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 4 weeks||||0.008
71803965|NCT03794089|143107133|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 8 weeks||||<0.001
71803966|NCT03794089|143107133|SUPERIORITY|Testing null hypothesis of no difference between groups|||||<|0.001||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to 12 weeks||||<0.001
71803967|NCT03794089|143107133|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.008||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Depression subscale total from Baseline to Post-assessment (16 weeks)||||0.008
71803968|NCT03794089|143107134|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.44||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 4 weeks||||0.440
71894212|NCT01982630|143310406|OTHER||Difference of Least Squares Means|3.34|||||TWO_SIDED|90.0|-0.7|7.39|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||7.39|-0.70|
71803969|NCT03794089|143107134|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.022||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 8 weeks||||0.022
71803970|NCT03794089|143107134|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to 12 weeks||||0.032
71803971|NCT03794089|143107134|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.091||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in DASS-21 Stress subscale total from Baseline to Post-assessment (16 weeks)||||0.091
71803972|NCT03794089|143107135|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.058||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 4 weeks||||0.058
71803973|NCT03794089|143107135|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.032||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 8 weeks||||0.032
71803974|NCT03794089|143107135|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.007||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to 12 weeks||||0.007
71803975|NCT03794089|143107135|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.044||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in OASIS total score from Baseline to Post assessment (16 weeks)||||0.044
71803976|NCT03794089|143107136|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.328||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 4 weeks||||0.328
71803977|NCT03794089|143107136|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.148||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 8 weeks||||0.148
71803978|NCT03794089|143107136|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.002||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to 12 weeks||||0.002
71803979|NCT03794089|143107136|SUPERIORITY|Testing null hypothesis of no difference between groups||||||0.069||||||a priori threshold for statistical significance was p\<=0.05|Mixed Models Analysis|||Change in ODSIS total from Baseline to Post-assessment (16 weeks)||||0.069
71803980|NCT03794089|143107137|SUPERIORITY|||||||0.928||||||a priori threshold for statistical significance was p\<=0.05|ANCOVA|||comparisons of groups at post-assessment controls for baseline Q-LES-Q-SF total scores||||0.928
71803981|NCT03794089|143107138|SUPERIORITY|||||||0.402||||||a priori threshold for statistical significance was p\<.05|Fisher Exact|degrees of freedom = 1||Testing null hypothesis of no difference between groups||||0.402
71803982|NCT03794089|143107139|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||<0.001
71803983|NCT03794089|143107140|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|Used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||.006
71803984|NCT03794089|143107141|SUPERIORITY|||||||0.004||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|used Satterthwaite method given unequal variances||Testing the null hypothesis of no difference between groups||||0.004
71803985|NCT03794089|143107142|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance was p\<=.05|t-test, 2 sided|||Testing the null hypothesis of no difference between groups||||0.002
71803986|NCT00116805|143107165|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 160 subjects in the TDF group and 80 subjects in the ADV group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the TDF treatment was inferior to the ADV treatment (the difference in proportions was less than -0.080) in favor of the alternative hypothesis that the TDF treatment was not inferior.|Difference in proportions|54.1|STANDARD_ERROR_OF_MEAN|4.8|<|0.001|TWO_SIDED|95.0|44.6|63.6||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≤ 4 x upper limit of the normal range \[ULN\] or \> 4 x ULN) difference is 0.|Z-test|2-sided 95% confidence interval (CI), stratified by baseline ALT was used to evaluate difference between groups in proportion of complete responders.||||63.6|44.6|<0.001
71803987|NCT00116805|143107166|SUPERIORITY_OR_OTHER||Difference in proportions|63.1|STANDARD_ERROR_OF_MEAN|4.7|<|0.001|TWO_SIDED|95.0|53.8|72.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero.|Z-test|Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||||72.3|53.8|<0.001
71803988|NCT00116805|143107167|SUPERIORITY_OR_OTHER||Difference in proportions|-1.4|STANDARD_ERROR_OF_MEAN|5.4||0.801|TWO_SIDED|95.0|-12.0|9.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero.|Z-test|Two-sided 95% CIs, stratified by baseline ALT (baseline ALT ≤ 4 x ULN or \> 4 x ULN), were used to evaluate treatment group differences.||||9.3|-12.0|0.801
71803989|NCT00116805|143107172|SUPERIORITY_OR_OTHER||Difference in proportions|5.8|STANDARD_ERROR_OF_MEAN|5.8||0.32|TWO_SIDED|95.0|-5.6|17.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||||17.2|-5.6|0.320
71803990|NCT00116805|143107178|SUPERIORITY_OR_OTHER||Difference in proportions|13.6|STANDARD_ERROR_OF_MEAN|6.4||0.032|TWO_SIDED|95.0|1.1|26.1||P-value corresponds to a Z-test. Statistical tests were not adjusted for baseline ALT stratum.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||26.1|1.1|0.032
71803991|NCT00116805|143107179|SUPERIORITY_OR_OTHER||Difference in proportions|-9.8|STANDARD_ERROR_OF_MEAN|6.0||0.1|TWO_SIDED|95.0|-21.5|1.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).||||1.9|-21.5|0.100
71803992|NCT00116805|143107184|SUPERIORITY_OR_OTHER||Difference in proportions|6.1|STANDARD_ERROR_OF_MEAN|5.3||0.245|TWO_SIDED|95.0|-4.2|16.4||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||16.4|-4.2|0.245
71894213|NCT01982630|143310406|OTHER||Difference of Least Squares Means|8.88|||||TWO_SIDED|90.0|3.53|14.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||14.23|3.53|
71803993|NCT00116805|143107184|SUPERIORITY_OR_OTHER||Difference in proportions|4.7|STANDARD_ERROR_OF_MEAN|5.2||0.363|TWO_SIDED|95.0|-5.5|14.9||P-value for HBeAg seroconversion corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg seroconversion.||14.9|-5.5|0.363
71803994|NCT00116805|143107185|SUPERIORITY_OR_OTHER||Difference in proportions|0.3|STANDARD_ERROR_OF_MEAN|5.9||0.963|TWO_SIDED|95.0|-11.3|11.9||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).||This information pertains to HBeAg loss.||11.9|-11.3|0.963
71803995|NCT00116805|143107185|SUPERIORITY_OR_OTHER||Difference in proportions|0.7|STANDARD_ERROR_OF_MEAN|5.6||0.904|TWO_SIDED|95.0|-10.4|11.7||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \>4 x ULN).||This information pertains to seroconversion to anti-HBe.||11.7|-10.4|0.904
71803996|NCT00116805|143107186|SUPERIORITY_OR_OTHER||Difference in proportions|10.9|STANDARD_ERROR_OF_MEAN|4.6||0.018|TWO_SIDED|95.0|1.9|19.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||19.9|1.9|0.018
71841421|NCT03295721|143192534|SUPERIORITY||Risk Difference (RD)|0.177||||0.0001|TWO_SIDED|95.0|0.085|0.265|||Fisher Exact|||||.265|.085|0.0001
71841422|NCT03295721|143192535|SUPERIORITY||||||=|0.0022|||||||Wilcoxon (Mann-Whitney)|||||||= 0.0022
71675316|NCT01908829|142868076|SUPERIORITY||LS Means|2.5|STANDARD_ERROR_OF_MEAN|1.0|=|0.012|TWO_SIDED|95.0|0.55|4.46||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.46|0.55|=0.012
71675317|NCT01908829|142868076|SUPERIORITY||LS Means|3.61|STANDARD_ERROR_OF_MEAN|1.05|=|0.001|TWO_SIDED|95.0|1.54|5.67||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.67|1.54|=0.001
71675318|NCT01908829|142868076|SUPERIORITY||LS Means|3.28|STANDARD_ERROR_OF_MEAN|1.03|=|0.001|TWO_SIDED|95.0|1.27|5.29||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||5.29|1.27|=0.001
71675319|NCT01908829|142868077|SUPERIORITY||LS Means|0.54|STANDARD_ERROR_OF_MEAN|0.96|=|0.575|TWO_SIDED|95.0|-1.35|2.43||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.43|-1.35|=0.575
71675320|NCT01908829|142868077|SUPERIORITY||LS Means|1.61|STANDARD_ERROR_OF_MEAN|1.0|=|0.109|TWO_SIDED|95.0|-0.36|3.58||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.58|-0.36|=0.109
71803997|NCT00116805|143107186|SUPERIORITY_OR_OTHER||Difference in proportions|4.3|STANDARD_ERROR_OF_MEAN|3.0||0.148|TWO_SIDED|95.0|-1.5|10.2||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg seroconversion.||10.2|-1.5|0.148
71803998|NCT00116805|143107187|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.9||0.757|TWO_SIDED|95.0|-4.8|6.5||P-value above for HBsAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to HBsAg loss.||6.5|-4.8|0.757
71803999|NCT00116805|143107187|SUPERIORITY_OR_OTHER||Difference in proportions|0.9|STANDARD_ERROR_OF_MEAN|2.6||0.733|TWO_SIDED|95.0|-4.2|5.9||P-value above corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or \> 4 x ULN).|Z-test|||This information pertains to seroconversion to anti-HBs.||5.9|-4.2|0.733
71804000|NCT03320070|143107217|SUPERIORITY|||||||0.5076|||||||Chi-squared|||||||0.5076
71804001|NCT03320070|143107219|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
71804002|NCT03320070|143107221|SUPERIORITY|||||||0.0848|||||||Chi-squared|||||||0.0848
71804003|NCT03320070|143107223|SUPERIORITY|||||||0.2005|||||||Chi-squared|||||||0.2005
71804004|NCT03320070|143107225|SUPERIORITY|||||||0.9416|||||||Chi-squared|||||||0.9416
71804005|NCT03320070|143107227|SUPERIORITY|||||||0.1853|||||||Chi-squared|||||||0.1853
71804006|NCT04088097|143107234|SUPERIORITY|||||||0.01|||||||ANOVA|||||||.01
71804007|NCT04088097|143107235|SUPERIORITY|||||||0.75|||||||ANOVA|||||||.75
71804008|NCT04088097|143107236|SUPERIORITY|||||||0.03|||||||ANOVA|||||||.03
71804009|NCT03556761|143107239|SUPERIORITY||Risk Ratio (RR)|0.4||||0.03|TWO_SIDED|95.0|0.2|0.81|||Regression, Linear|||||0.81|0.20|0.03
71804010|NCT03556761|143107240|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.12|TWO_SIDED|95.0|0.95|1.51|||Regression, Cox|||||1.51|0.95|0.12
71804011|NCT03556761|143107241|SUPERIORITY||Risk Ratio (RR)|0.55||||0.14|TWO_SIDED|95.0|0.25|1.21|||Chi-squared|||||1.21|0.25|0.14
71804012|NCT03556761|143107242|SUPERIORITY||Risk Ratio (RR)|0.87||||0.36|TWO_SIDED|95.0|0.64|1.18|||Chi-squared|||||1.18|0.64|0.36
71804013|NCT03556761|143107243|SUPERIORITY||Risk Ratio (RR)|0.02||||0.76|TWO_SIDED|95.0|-0.09|0.13|||Regression, Linear|||||.13|-0.09|0.76
71804014|NCT03556761|143107244|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71804015|NCT03556761|143107245|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.32|28.59||||||||28.59|0.32|
71804016|NCT03556761|143107246|SUPERIORITY||Risk Ratio (RR)|0.61||||0.03|TWO_SIDED|95.0|0.39|0.96|||Chi-squared|||||0.96|0.39|0.03
71804017|NCT00693992|143107251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.0006|TWO_SIDED|95.0|0.47|0.82|||Log Rank|||||0.82|0.47|0.0006
71804018|NCT00693992|143107252|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.89|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.89
71804019|NCT00693992|143107254|SUPERIORITY|||||||0.0061|||||||Fisher Exact|||||||0.0061
71804020|NCT00693992|143107255|SUPERIORITY|||||||0.8393|||||||Fisher Exact|||||||0.8393
71894214|NCT01982630|143310406|OTHER||Difference of Least Squares Means|5.54|||||TWO_SIDED|90.0|-0.08|11.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline peak heart rate as a covariate||||11.15|-0.08|
71894215|NCT01982630|143310407|OTHER||Difference of Least Squares Means|-3.55|||||TWO_SIDED|90.0|-6.98|-0.12|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.12|-6.98|
71894216|NCT01982630|143310407|OTHER||Difference of Least Squares Means|1.05|||||TWO_SIDED|90.0|-3.38|5.49|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.49|-3.38|
71894217|NCT01982630|143310407|OTHER||Difference of Least Squares Means|4.61|||||TWO_SIDED|90.0|-0.02|9.23|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||9.23|-0.02|
71894218|NCT01982630|143310408|OTHER||Difference of Least Squares Means|-1.16|||||TWO_SIDED|90.0|-4.59|2.28|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||2.28|-4.59|
71675321|NCT01908829|142868077|SUPERIORITY||LS Means|2.26|STANDARD_ERROR_OF_MEAN|1.05|=|0.032|TWO_SIDED|95.0|0.2|4.32||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.32|0.20|=0.032
71675322|NCT01908829|142868077|SUPERIORITY||LS Means|1.86|STANDARD_ERROR_OF_MEAN|1.02|=|0.069|TWO_SIDED|95.0|-0.15|3.87||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.87|-0.15|=0.069
71804021|NCT00996996|143107268|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|90.0|100.0|||||The estimated value represents the percentage of participants with a confirmed response.|||100|90|
71804022|NCT00996996|143107269|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|||||TWO_SIDED|95.0|94.0|100.0|||||The estimated value represents the percentage of participants with a response.|||100|94|
71804023|NCT00996996|143107270|SUPERIORITY_OR_OTHER||Percentage of participants|70.0|||||TWO_SIDED|95.0|59.0|80.0|||||The estimated value represents the percentage of participants with a confirmed CR.|||80|59|
71804024|NCT00996996|143107270|SUPERIORITY_OR_OTHER||Percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|6.0|||||The estimated value represents the percentage of participants with a confirmed CCR.|||6|0|
71804025|NCT00996996|143107270|SUPERIORITY_OR_OTHER||Percentage of participants|75.0|||||TWO_SIDED|95.0|65.0|85.0|||||The estimated value represents the percentage of participants with confirmed CR + confirmed CCR.|||85|65|
71804026|NCT00996996|143107270|SUPERIORITY_OR_OTHER||Percentage of participants|17.0|||||TWO_SIDED|95.0|9.0|26.0|||||The estimated value represents the percentage of participants with a confirmed PR.|||26|9|
71804027|NCT00996996|143107271|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|64.0|84.0|||||The estimated value represents the percentage of participants with a CR.|||84|64|
71804028|NCT00996996|143107271|SUPERIORITY_OR_OTHER||Percentage of participants|4.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with a CCR.|||8|0|
71804029|NCT00996996|143107271|SUPERIORITY_OR_OTHER||Percentage of participants|78.0|||||TWO_SIDED|95.0|68.0|87.0|||||The estimated value represents the percentage of participants with a CR + CCR.|||87|68|
71804030|NCT00996996|143107271|SUPERIORITY_OR_OTHER||Percentage of participants|20.0|||||TWO_SIDED|95.0|11.0|29.0|||||The estimated value represents the percentage of participants with a PR.|||29|11|
71804031|NCT01175382|143107314|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.||||<.0001
71804032|NCT01175382|143107315|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.||||.0013
71804033|NCT01175382|143107316|SUPERIORITY_OR_OTHER|||||||0.2933|||||||ANCOVA|||Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.||||0.2933
71804034|NCT01175382|143107317|SUPERIORITY_OR_OTHER|||||||0.0051|||||||ANCOVA|||Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.||||0.0051
71804035|NCT01175382|143107318|SUPERIORITY_OR_OTHER|||||||0.1402|||||||ANCOVA|||Analysis of Covariance comparing mean change score among groups controlling for age and baseline score||||.1402
71804036|NCT01175382|143107319|SUPERIORITY_OR_OTHER|||||||0.0015|||||||ANCOVA|||Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.||||0.0015
71804037|NCT01175382|143107320|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.||||<.0001
71894219|NCT01982630|143310408|OTHER||Difference of Least Squares Means|8.65|||||TWO_SIDED|90.0|3.99|13.31|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.31|3.99|
71894220|NCT01982630|143310408|OTHER||Difference of Least Squares Means|9.8|||||TWO_SIDED|90.0|4.96|14.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.65|4.96|
71675323|NCT01908829|142868078|SUPERIORITY||LS Means|1.73|STANDARD_ERROR_OF_MEAN|0.83|=|0.037|TWO_SIDED|95.0|0.1|3.36||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||3.36|0.10|=0.037
71804038|NCT01175382|143107321|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||"Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data."||||<.0001
71804039|NCT01175382|143107322|SUPERIORITY_OR_OTHER|||||||0.0022|||||||Cochran-Mantel-Haenszel|||||||0.0022
71804040|NCT01175382|143107323|SUPERIORITY_OR_OTHER|||||||0.0222|||||||Cochran-Mantel-Haenszel|||||||.0222
71804041|NCT01175382|143107324|SUPERIORITY_OR_OTHER|||||||0.0217|||||||Cochran-Mantel-Haenszel|||||||.0217
71804042|NCT01175382|143107325|SUPERIORITY_OR_OTHER|||||||0.669|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.||||0.6690
71841423|NCT04047602|143192588|EQUIVALENCE|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.|Binomial Proportion|0.083||||0.234|TWO_SIDED|95.0|0.002|0.385||The p-value reported is the one-sided p-value from the exact equivalence binomial test using an alpha value of 0.05.|Exact Binomial Test||The binomial proportion 95% confidence intervals were calculated using the Clopper-Pearson (Exact) method.|The observed proportion of evaluable patients with symptomatic radiation necrosis was calculated and tested against a baseline 6-month symptomatic radiation necrosis rate of 16% at a type I error rate of 5% using a one-sided binomial exact test. The null hypothesis is that the observed proportion is equivalent to 16% or 0.160.||0.385|0.002|0.234
71841424|NCT04047602|143192591|OTHER|||||||0.285|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.285
71841425|NCT04047602|143192592|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
71894221|NCT01982630|143310409|OTHER||Difference of Least Squares Means|-4.04|||||TWO_SIDED|90.0|-7.52|-0.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||-0.56|-7.52|
71894222|NCT01982630|143310409|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|5.57|14.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||14.89|5.57|
71894223|NCT01982630|143310409|OTHER||Difference of Least Squares Means|14.27|||||TWO_SIDED|90.0|9.38|19.15|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||19.15|9.38|
71894224|NCT01982630|143310410|OTHER||Difference of Least Squares Means|-2.12|||||TWO_SIDED|90.0|-5.7|1.47|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||1.47|-5.70|
71894225|NCT01982630|143310410|OTHER||Difference of Least Squares Means|13.34|||||TWO_SIDED|90.0|8.64|18.03|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||18.03|8.64|
71894226|NCT01982630|143310410|OTHER||Difference of Least Squares Means|15.45|||||TWO_SIDED|90.0|10.53|20.38|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||20.38|10.53|
71894227|NCT01982630|143310411|OTHER||Difference of Least Squares Means|2.11|||||TWO_SIDED|90.0|-1.47|5.7|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||5.70|-1.47|
71894228|NCT01982630|143310411|OTHER||Difference of Least Squares Means|10.43|||||TWO_SIDED|90.0|5.73|15.13|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||15.13|5.73|
71894229|NCT01982630|143310411|OTHER||Difference of Least Squares Means|8.32|||||TWO_SIDED|90.0|3.4|13.24|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline RMHR as a covariate||||13.24|3.40|
71894230|NCT01982630|143310427|OTHER||Difference of Least Squares Means|29.56|||||TWO_SIDED|90.0|4.34|54.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||54.77|4.34|
71894231|NCT01982630|143310427|OTHER||Difference of Least Squares Means|26.1|||||TWO_SIDED|90.0|2.02|50.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||50.19|2.02|
71894232|NCT01982630|143310427|OTHER||Difference of Least Squares Means|3.45|||||TWO_SIDED|90.0|-20.23|27.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||27.14|-20.23|
71894233|NCT01982630|143310427|OTHER||Difference of Least Squares Means|-26.45|||||TWO_SIDED|90.0|-49.96|-2.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-2.93|-49.96|
71894234|NCT01982630|143310427|OTHER||Difference of Least Squares Means|-29.9|||||TWO_SIDED|90.0|-52.04|-7.77|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.77|-52.04|
71894235|NCT01982630|143310427|OTHER||Difference of Least Squares Means|-56.0|||||TWO_SIDED|90.0|-79.53|-32.48|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-32.48|-79.53|
71894236|NCT01982630|143310428|OTHER||Difference of Least Squares Means|14.96|||||TWO_SIDED|90.0|-10.25|40.18|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||40.18|-10.25|
71894237|NCT01982630|143310428|OTHER||Difference of Least Squares Means|6.57|||||TWO_SIDED|90.0|-17.52|30.65|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||30.65|-17.52|
71894238|NCT01982630|143310428|OTHER||Difference of Least Squares Means|8.4|||||TWO_SIDED|90.0|-15.29|32.08|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||32.08|-15.29|
71675324|NCT01908829|142868078|SUPERIORITY||LS Means|1.09|STANDARD_ERROR_OF_MEAN|0.85|=|0.199|TWO_SIDED|95.0|-0.57|2.76||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||2.76|-0.57|=0.199
71804043|NCT01175382|143107326|SUPERIORITY_OR_OTHER|||||||0.0812|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.||||0.0812
71804044|NCT01175382|143107327|SUPERIORITY_OR_OTHER|||||||0.5578|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.||||0.5578
71804045|NCT01175382|143107328|SUPERIORITY_OR_OTHER|||||||0.0279|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.||||0.0279
71804046|NCT01175382|143107329|SUPERIORITY_OR_OTHER|||||||0.2553|||||||ANCOVA|||Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groups||||0.2553
71804047|NCT01175382|143107330|SUPERIORITY_OR_OTHER|||||||0.3165|||||||Cochran-Mantel-Haenszel|||||||0.3165
71804048|NCT01175382|143107331|SUPERIORITY_OR_OTHER|||||||0.8153|||||||Cochran-Mantel-Haenszel|||||||0.8153
71804049|NCT01175382|143107332|SUPERIORITY_OR_OTHER|||||||0.5536|||||||Cochran-Mantel-Haenszel|||||||0.5536
71804050|NCT01175382|143107333|SUPERIORITY_OR_OTHER|||||||0.2035|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing data||||0.2035
71804051|NCT01175382|143107334|SUPERIORITY_OR_OTHER|||||||0.0549|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing data||||.0549
71804052|NCT01175382|143107335|SUPERIORITY_OR_OTHER|||||||0.507|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing data||||0.5070
71804053|NCT01175382|143107336|SUPERIORITY_OR_OTHER|||||||0.0529|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing data||||.0529
71804054|NCT01175382|143107337|SUPERIORITY_OR_OTHER|||||||0.2384|||||||ANCOVA|||Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.||||0.2384
71804055|NCT01148810|143107368|SUPERIORITY_OR_OTHER||Bayesian analysis|0.96|||||||||||||||Probability that the difference (BAF312-Placebo) is greater than the threshold|||
71804056|NCT01248884|143107395|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
71804057|NCT01248884|143107395|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.3||||||||2.3|-2.25|
71804058|NCT01248884|143107395|NON_INFERIORITY|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
71804059|NCT01248884|143107395|NON_INFERIORITY|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||TWO_SIDED|97.5|-2.25|2.27||||||||2.27|-2.25|
71894239|NCT01982630|143310428|OTHER||Difference of Least Squares Means|-35.23|||||TWO_SIDED|90.0|-58.75|-11.72|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.72|-58.75|
71894240|NCT01982630|143310428|OTHER||Difference of Least Squares Means|-43.63|||||TWO_SIDED|90.0|-65.77|-21.5|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.50|-65.77|
71894241|NCT01982630|143310428|OTHER||Difference of Least Squares Means|-50.2|||||TWO_SIDED|90.0|-73.72|-26.68|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-26.68|-73.72|
71675325|NCT01908829|142868078|SUPERIORITY||LS Means|2.62|STANDARD_ERROR_OF_MEAN|0.87|=|0.003|TWO_SIDED|95.0|0.92|4.31||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.31|0.92|=0.003
71675326|NCT01908829|142868078|SUPERIORITY||LS Means|2.48|STANDARD_ERROR_OF_MEAN|0.85|=|0.004|TWO_SIDED|95.0|0.81|4.15||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs \& p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors \& baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||4.15|0.81|=0.004
71804060|NCT01248884|143107397|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.26|||||TWO_SIDED|97.5|1.11|1.44||||||||1.44|1.11|
71804061|NCT01248884|143107397|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.33|||||TWO_SIDED|97.5|1.14|1.54||||||||1.54|1.14|
71804062|NCT01248884|143107397|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.25|||||TWO_SIDED|97.5|1.1|1.43||||||||1.43|1.1|
71804063|NCT01248884|143107397|NON_INFERIORITY|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.58|||||TWO_SIDED|97.5|1.37|1.84||||||||1.84|1.37|
71804064|NCT01248884|143107398|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-3.52|||||TWO_SIDED|97.5|-10.19|3.0||||||||3|-10.19|
71804065|NCT01248884|143107398|NON_INFERIORITY|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.57|||||TWO_SIDED|97.5|-6.53|7.7||||||||7.7|-6.53|
71804066|NCT01248884|143107399|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.56|||||TWO_SIDED|97.5|-3.27|4.63||||||Immune response non-inferiority - anti-HBs (ELISA)||4.63|-3.27|
71804067|NCT01248884|143107399|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.94|||||TWO_SIDED|97.5|-4.57|2.36||||||Immune response non-inferiority - anti-HBs (ELISA)||2.36|-4.57|
71804068|NCT01248884|143107399|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.4|||||TWO_SIDED|97.5|-4.62|3.8||||||Immune response non-inferiority - anti-HBs (CLIA)||3.8|-4.62|
71804069|NCT01248884|143107399|NON_INFERIORITY|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.92|||||TWO_SIDED|97.5|-5.07|3.02||||||Immune response non-inferiority - anti-HBs (CLIA)||3.02|-5.07|
71804070|NCT02703844|143107453|SUPERIORITY|||||||0.0089|||||||ANCOVA|||||||0.0089
71804071|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.132|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.132
71841426|NCT04047602|143192593|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
71841427|NCT04047602|143192596|OTHER|||||||0.248|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across SRS groups. The null hypothesis was that the survival probabilities were equal.||||0.248
71841428|NCT04047602|143192597|OTHER|||||||0.292|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across brain metastases groups. The null hypothesis was that the survival probabilities were equal.||||0.292
71841429|NCT04047602|143192598|OTHER|||||||0.289|||||||Klein Method|||The method of Klein et al., (Klein et.al., 2007) was used to compare the 12-month survival probabilities across ICI groups. The null hypothesis was that the survival probabilities were equal.||||0.289
71841430|NCT04484428|143192636|SUPERIORITY|||||||0.773|||||||ANCOVA|||||||0.773
71841431|NCT04484428|143192637|SUPERIORITY|||||||0.972|||||||ANCOVA|||||||0.972
71841432|NCT04484428|143192638|SUPERIORITY|||||||0.617|||||||ANCOVA|||||||0.617
71841433|NCT04484428|143192639|SUPERIORITY|||||||0.796|||||||ANCOVA|||||||0.796
71841434|NCT04484428|143192640|SUPERIORITY|||||||0.96|||||||ANCOVA|||||||0.960
71841435|NCT04484428|143192641|SUPERIORITY|||||||0.761|||||||ANCOVA|||||||0.761
71841436|NCT04484428|143192642|SUPERIORITY|||||||0.979|||||||ANCOVA|||||||0.979
71841437|NCT04484428|143192643|SUPERIORITY|||||||0.803|||||||ANCOVA|||||||0.803
71841438|NCT03825588|143192644|SUPERIORITY|||||||0.71||||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of actual suicide attempts||||0.71
71841439|NCT03825588|143192644|SUPERIORITY|||||||0.43||||||False Discovery Rate q-vale \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of actual suicide attempts||||0.43
71804072|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.658|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.658
71804073|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.142|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.142
71841440|NCT03825588|143192644|SUPERIORITY||Odds Ratio (OR)|0.4||||0.21|TWO_SIDED|95.0|0.1|1.66||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.66|0.10|0.21
71841441|NCT03825588|143192644|SUPERIORITY||Odds Ratio (OR)|1.31||||0.57|TWO_SIDED|95.0|0.51|3.34||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of ASAP||3.34|0.51|0.57
71804074|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.207|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.207
71804075|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.077|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.077
71804076|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.331|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||0.331
71804077|NCT02828111|143107468|OTHER|Pairwise comparison||||||0.117|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of all four patidegib gel treatment groups combined compared with vehicle gel at Week 12.||||0.117
71804078|NCT02828111|143107472|OTHER|Pairwise comparison||||||0.038|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.038
71804079|NCT02828111|143107472|OTHER|Pairwise comparison||||||0.099|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.099
71804080|NCT02828111|143107472|OTHER|Pairwise comparison||||||0.198|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.198
71804081|NCT02828111|143107472|OTHER|Pairwise comparison||||||0.757|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12||||0.757
71804082|NCT02828111|143107473|OTHER|Pairwise comparison||||||0.043|||||||Fisher Exact|||at Week 12||||0.043
71804083|NCT02828111|143107473|OTHER|Pairwise comparison||||||0.312|||||||Fisher Exact|||at Week 12||||0.312
71804084|NCT02828111|143107473|OTHER|Pairwise comparison||||||0.353|||||||Fisher Exact|||at Week 12||||0.353
71804085|NCT02828111|143107473|OTHER|Pairwise comparison||||||0.093|||||||Fisher Exact|||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.||||0.093
71804086|NCT02828111|143107473|OTHER|Pairwise comparison||||||1|||||||Fisher Exact|||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.||||1.000
71804087|NCT02828111|143107473|OTHER|Pairwise comparison||||||0.157|||||||Fisher Exact|||This is the analysis of all four patidegib gel treatment groups combined compared with combined vehicle gel at Week 12.||||0.157
71804088|NCT00736996|143107489|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with PIO was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
71804089|NCT00736996|143107489|SUPERIORITY_OR_OTHER||||||<|0.0125|TWO_SIDED|||||Statistical significance was defined as a 2-sided p-value \< 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with EET was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.||||<0.0125
71804090|NCT00736996|143107490|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
71804091|NCT00736996|143107490|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
71841442|NCT03825588|143192644|SUPERIORITY||Odds Ratio (OR)|1.15||||0.77|TWO_SIDED|95.0|0.44|2.97||False Discovery Rate q-value \> 0.99|Regression, Logistic|||Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of BRITE.||2.97|0.44|0.77
71841443|NCT03825588|143192644|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.74|TWO_SIDED|95.0|0.48|1.69||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on time to actual suicide attempt||1.69|0.48|0.74
71841444|NCT03825588|143192644|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.45|TWO_SIDED|95.0|0.42|1.48||False Discovery Rate q-vale \> 0.99|Regression, Cox|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the time to actual suicide attempt||1.48|0.42|0.45
71841445|NCT03825588|143192644|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.25|TWO_SIDED|95.0|0.13|1.72||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Interaction effect of ASAP and BRITE||1.72|0.13|0.25
71841446|NCT03825588|143192644|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.62|TWO_SIDED|95.0|0.54|2.87||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.87|0.54|0.62
71894242|NCT01982630|143310429|OTHER||Difference of Least Squares Means|-31.2|||||TWO_SIDED|90.0|-56.59|-5.81|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.81|-56.59|
71894243|NCT01982630|143310429|OTHER||Difference of Least Squares Means|-25.12|||||TWO_SIDED|90.0|-50.25|0.01|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||0.01|-50.25|
71894244|NCT01982630|143310429|OTHER||Difference of Least Squares Means|-6.08|||||TWO_SIDED|90.0|-17.31|5.14|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||5.14|-17.31|
71894245|NCT01982630|143310430|OTHER||Difference of Least Squares Means|-27.48|||||TWO_SIDED|90.0|-52.87|-2.09|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-2.09|-52.87|
71894246|NCT01982630|143310430|OTHER||Difference of Least Squares Means|-30.59|||||TWO_SIDED|90.0|-55.72|-5.46|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||-5.46|-55.72|
71894247|NCT01982630|143310430|OTHER||Difference of Least Squares Means|3.11|||||TWO_SIDED|90.0|-8.11|14.34|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||14.34|-8.11|
71894248|NCT01982630|143310431|OTHER||Difference of Least Squares Means|4.59|||||TWO_SIDED|90.0|-20.88|30.06|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||30.06|-20.88|
71894249|NCT01982630|143310431|OTHER||Difference of Least Squares Means|-5.42|||||TWO_SIDED|90.0|-30.68|19.85|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||19.85|-30.68|
71894250|NCT01982630|143310431|OTHER||Difference of Least Squares Means|10.01|||||TWO_SIDED|90.0|-1.77|21.78|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||21.78|-1.77|
71894251|NCT01982630|143310432|OTHER||Difference of Least Squares Means|-14.98|||||TWO_SIDED|90.0|-40.53|10.57|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.57|-40.53|
71894252|NCT01982630|143310432|OTHER||Difference of Least Squares Means|-14.5|||||TWO_SIDED|90.0|-39.77|10.76|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||10.76|-39.77|
71894253|NCT01982630|143310432|OTHER||Difference of Least Squares Means|-0.48|||||TWO_SIDED|90.0|-12.47|11.52|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline FPG as a covariate||||11.52|-12.47|
71894254|NCT01982630|143310433|OTHER||Difference of Least Squares Means|-43.68|||||TWO_SIDED|90.0|-65.81|-21.55|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-21.55|-65.81|
71894255|NCT01982630|143310433|OTHER||Difference of Least Squares Means|-47.4|||||TWO_SIDED|90.0|-69.35|-25.45|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-25.45|-69.35|
71804092|NCT00736996|143107491|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
71894256|NCT01982630|143310433|OTHER||Difference of Least Squares Means|3.72|||||TWO_SIDED|90.0|-5.76|13.19|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||13.19|-5.76|
71894257|NCT01982630|143310434|OTHER||Difference of Least Squares Means|-34.01|||||TWO_SIDED|90.0|-56.14|-11.88|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.88|-56.14|
71804093|NCT00736996|143107491|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.||||<0.05
71804094|NCT02667912|143107510|SUPERIORITY||Mean Difference (Final Values)|10.8||||0.045|TWO_SIDED|95.0|0.3|21.4||The a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||21.4|0.3|0.045
71804095|NCT02667912|143107513|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71804096|NCT02667912|143107514|OTHER|||||||0.203|||||||t-test, 2 sided|||||||0.203
71804097|NCT02667912|143107515|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.27|TWO_SIDED|95.0|-11.9|3.4|||t-test, 2 sided|||||3.4|-11.9|0.27
71894258|NCT01982630|143310434|OTHER||Difference of Least Squares Means|-39.2|||||TWO_SIDED|90.0|-61.15|-17.26|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-17.26|-61.15|
71894259|NCT01982630|143310434|OTHER||Difference of Least Squares Means|5.2|||||TWO_SIDED|90.0|-4.28|14.67|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||14.67|-4.28|
71894260|NCT01982630|143310435|OTHER||Difference of Least Squares Means|-23.73|||||TWO_SIDED|90.0|-45.89|-1.56|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.56|-45.89|
71894261|NCT01982630|143310435|OTHER||Difference of Least Squares Means|-33.95|||||TWO_SIDED|90.0|-55.93|-11.98|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-11.98|-55.93|
71894262|NCT01982630|143310435|OTHER||Difference of Least Squares Means|10.23|||||TWO_SIDED|90.0|0.56|19.89|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||19.89|0.56|
71841447|NCT03825588|143192644|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.83|TWO_SIDED|95.0|0.47|2.59||False Discovery Rate q-value \> 0.99|Regression, Cox|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||2.59|0.47|0.83
71804098|NCT02667912|143107516|SUPERIORITY||Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|5.7||0.17|TWO_SIDED|95.0|-3.7|19.3||The a priori threshold for statistical significance p\<0.05|t-test, 2 sided|||||19.3|-3.7|0.17
71804099|NCT02667912|143107519|SUPERIORITY|||||||0.213|||||||t-test, 2 sided|||||||0.213
71804100|NCT02667912|143107520|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
71841448|NCT03825588|143192645|SUPERIORITY|||||||0.19||||||False Discovery Rate q-value = 0.72|Chi-squared|||Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of suicidal events|We used standard univariate statistics to compare partici- pants' baseline sociodemographics and clinical characteris- tics by arm \[(ASAP vs No ASAP where comparison is 6 www.jaacap.org (ASAP+TAU) and (ASAP+BRITE+TAU) vs (TAU alone) and (BRITE+TAU); and BRITE vs No BRITE where comparison is (ASAP+BRITE+TAU) and (BRITE+TAU) vs (ASAP+TAU) and (TAU Alone)\], site, retention, pre- post-COVID and recruitment venue. We then tested for equality of the 2 cells (ASAP vs no ASAP, BRITE vs no BRITE) or 4 cells (ASAP+BRITE+TAU vs BRITE +TAU vs ASAP+TAU vs TAU Alone) without covariates on the rates of and time to suicidal behavior using the appropriate (t or F, c2, Kaplan-Meier, Cox models) test statistics. We then used mixed-effects regression models with arm (2 and 4 cells), time, and their interaction for continuous data. Presented percentages are based on all observed data.|||0.19
71804101|NCT02667912|143107521|OTHER|||||||0.304|||||||t-test, 2 sided|||||||0.304
71841449|NCT03825588|143192645|SUPERIORITY|||||||0.89|TWO_SIDED|95.0||||False Discovery Rate q-value \> 0.99|Chi-squared|||Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal events||||0.89
71841450|NCT03825588|143192645|SUPERIORITY||Odds Ratio (OR)|0.35||||0.08|TWO_SIDED|95.0|0.11|1.1||False Discovery Rate q-value = 0.72|Regression, Logistic|||Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE.||1.10|0.11|0.08
71841451|NCT03825588|143192645|SUPERIORITY||Odds Ratio (OR)|1.14||||0.74|TWO_SIDED|95.0|0.51|2.55||False Discovery Rate q \> 0.99|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.||2.55|0.51|0.74
71841452|NCT03825588|143192645|SUPERIORITY||Odds Ratio (OR)|1.69||||0.19|TWO_SIDED|95.0|0.77|3.69||False Discovery Rate q=0.72|Regression, Logistic|||Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.||3.69|0.77|0.19
71841453|NCT06149338|143192651|SUPERIORITY|||||||0.0002||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0002
71804102|NCT02667912|143107522|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71804103|NCT02667912|143107523|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71841454|NCT06149338|143192651|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71804104|NCT02667912|143107524|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71804105|NCT02667912|143107525|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71841455|NCT06149338|143192652|SUPERIORITY||||||<|0.0001||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||< 0.0001
71841456|NCT06149338|143192653|SUPERIORITY|||||||0.0041||||||Threshold for statistical significance: p \< 0.05|Chi-squared|||||||0.0041
71804106|NCT02667912|143107526|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71841457|NCT06149338|143192653|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71804107|NCT02667912|143107527|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
71804108|NCT02667912|143107528|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71804109|NCT02667912|143107529|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
71804110|NCT02667912|143107530|SUPERIORITY|||||||0.217|||||||t-test, 2 sided|||||||0.217
71804111|NCT02667912|143107531|SUPERIORITY|||||||0.238|||||||t-test, 2 sided|||||||0.238
71841458|NCT06149338|143192654|SUPERIORITY|||||||0.7895||||||Threshold for statistical significance: p \< 0.05|Kruskal-Wallis|||||||0.7895
71804112|NCT02667912|143107532|SUPERIORITY|||||||0.969|||||||t-test, 2 sided|||||||0.969
71841459|NCT01868997|143192708|SUPERIORITY||Odds Ratio (OR)|8.86|||<|0.001|TWO_SIDED|95.0|3.293|23.825||Odds ratio, 95% confidence interval, and P-value are obtained from a logistic regression model with treatment and smoking status as covariates.|Regression, Logistic|||||23.825|3.293|< 0.001
71841460|NCT01868997|143192709|SUPERIORITY||Difference in Least Squares Mean|10.97|STANDARD_ERROR_OF_MEAN|3.221||0.001|TWO_SIDED|95.0|4.561|17.375|||Mixed-Model Repeated Measures|||||17.375|4.561|0.001
71841461|NCT01868997|143192710|SUPERIORITY||Difference in Least Squares Mean|-2.31|STANDARD_ERROR_OF_MEAN|0.269|<|0.001|TWO_SIDED|95.0|-2.843|-1.772|||Mixed-Model Repeated Measures|||||-1.772|-2.843|< 0.001
71841462|NCT01868997|143192711|SUPERIORITY||Difference in Least Squares Mean|-1.59|STANDARD_ERROR_OF_MEAN|0.245|<|0.001|TWO_SIDED|95.0|-2.073|-1.098|||Mixed-Model Repeated Measures|||||-1.098|-2.073|< 0.001
71841463|NCT01868997|143192712|SUPERIORITY||Difference in Least Squares Mean|14.16|STANDARD_ERROR_OF_MEAN|3.827|<|0.001|TWO_SIDED|95.0|6.549|21.773|||Mixed-Model Repeated Measures|||||21.773|6.549|< 0.001
71841464|NCT01868997|143192713|SUPERIORITY||Difference in Least Squares Mean|6.32|STANDARD_ERROR_OF_MEAN|3.81||0.101|TWO_SIDED|95.0|-1.255|13.901|||Mixed-Model Repeated Measures|||||13.901|-1.255|0.101
71841465|NCT03308877|143192739|OTHER|||||||0.07||||||Covariates include education \& percent days abstinent at baseline.|Regression, Linear|||Hypothesis 1: Affective psychopathy scores will moderate response to a BMI such that individuals with lower scores will benefit relative to controls, but individuals with higher psychopathy scores will not benefit from the intervention in terms of percent days abstinent.||||.07
71841466|NCT03308877|143192739|OTHER|||||||0.02|||||||Regression, Linear|||Sensitivity analysis: proximal follow-up (3 months following BMI or SC)||||.02
71841467|NCT03308877|143192739|OTHER||B|0.063|||<|0.01|TWO_SIDED|95.0|0.007|0.156|||Regression, Linear|bias corrected bootstrap||Increased readiness to change will be associated with decreased substance use.||.156|.007|<.01
71841468|NCT03308877|143192740|OTHER|||||||0.74|||||||Regression, Linear|||||||.74
71841469|NCT03308877|143192741|OTHER|||||||0.88|||||||Regression, Logistic|||||||.88
71841470|NCT03643744|143192742|SUPERIORITY|||||||0.53|||||||ANOVA|||||||0.530
71841471|NCT03643744|143192742|SUPERIORITY|||||||0.727|||||||ANOVA|||||||0.727
71804113|NCT02667912|143107533|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||0.37
71804114|NCT00022516|143107544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.14|TWO_SIDED|95.0|0.6|1.06|||Log Rank|||||1.06|0.6|0.14
71804115|NCT00022516|143107545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.357|TWO_SIDED|95.0|0.65|1.17|||Log Rank|||||1.17|0.65|0.3570
71804116|NCT00022516|143107546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.3178|TWO_SIDED|95.0|0.62|1.17|||Log Rank|||||1.17|0.62|0.3178
71841472|NCT03643744|143192743|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71841473|NCT04487860|143192759|SUPERIORITY|||||||0.7905|||||||ANCOVA|||||||0.7905
71841474|NCT04487860|143192759|SUPERIORITY|||||||0.7372|||||||ANCOVA|||||||0.7372
71841475|NCT04487860|143192759|SUPERIORITY|||||||0.2989|||||||ANCOVA|||||||0.2989
71841476|NCT04487860|143192759|SUPERIORITY|||||||0.3328|||||||ANCOVA|||||||0.3328
71841477|NCT04487860|143192760|SUPERIORITY|||||||0.8989|||||||ANCOVA|||||||0.8989
71804117|NCT00022516|143107547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01|||Log Rank|||||1.01|0.6|0.06
71804118|NCT04433767|143107580|OTHER||Slope|-1.22|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Adjusted for age and gender.||||||< 0.001
71804119|NCT04433767|143107582|OTHER||Intercept|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.0127|TWO_SIDED|95.0|0.04|0.32|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.32|0.04|0.0127
71804120|NCT04433767|143107583|OTHER||Intercept|0.34|STANDARD_ERROR_OF_MEAN|0.08||0.0005|TWO_SIDED|95.0|0.17|0.51|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.51|0.17|0.0005
71804121|NCT04433767|143107584|OTHER||Intercept|0.19|STANDARD_ERROR_OF_MEAN|0.11||0.1027|TWO_SIDED|95.0|-0.04|0.42|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.42|-0.04|0.1027
71804122|NCT04433767|143107585|OTHER||Intercept|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.4846|TWO_SIDED|95.0|-0.18|0.37|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||0.37|-0.18|0.4846
71804123|NCT04433767|143107586|OTHER||Intercept|9.04|STANDARD_ERROR_OF_MEAN|25.77||0.729|TWO_SIDED|95.0|-44.28|62.36|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||62.36|-44.28|0.7290
71841478|NCT04487860|143192760|SUPERIORITY|||||||0.6768|||||||ANCOVA|||||||0.6768
71841479|NCT04487860|143192760|SUPERIORITY|||||||0.8209|||||||ANCOVA|||||||0.8209
71841480|NCT04487860|143192760|SUPERIORITY|||||||0.3106|||||||ANCOVA|||||||0.3106
71841481|NCT04487860|143192761|SUPERIORITY|||||||0.8593|||||||ANCOVA|||||||0.8593
71841482|NCT04487860|143192761|SUPERIORITY|||||||0.9594|||||||ANCOVA|||||||0.9594
71841483|NCT04487860|143192761|SUPERIORITY|||||||0.9041|||||||ANCOVA|||||||0.9041
71841484|NCT04487860|143192761|SUPERIORITY|||||||0.7147|||||||ANCOVA|||||||0.7147
71841485|NCT04359654|143192774|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71841486|NCT04359654|143192775|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71841487|NCT04359654|143192777|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71841488|NCT04359654|143192778|SUPERIORITY|||||||0.021|||||||Mixed Models Analysis|||The reported LS means are antilogs of the LS means estimated on the log scale.||||0.021
71841489|NCT05163496|143192779|SUPERIORITY||Mean Difference (Net)|12.0|STANDARD_DEVIATION|0.8|<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis was that the mean change in MADRS score from the preparation 1 session to day 28 would be the same in both niacin and psilocybin groups. The alternative hypothesis was that the change in the psilocybin group would be greater than the change in the niacin group, with an assumed true effect size of 1.06 SD units based on findings in prior studies. With 15 participants per group, this study had 80% power to observe a statistically significant difference between groups.||||<.001
71841490|NCT03625115|143192943|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley cognitive scores between the groups.||||||0.3|||||||t-test, 2 sided|||||||0.30
71841491|NCT03625115|143192944|SUPERIORITY||Pearson chi square (1)|8.51||||0.004|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who completed a multidisciplinary evaluation (referral completed).||||.004
71841492|NCT03625115|143192945|SUPERIORITY||Pearson chi square (1)|0.05||||0.82|TWO_SIDED||||||Chi-squared|||Chi-square test of independence to determine if there was a significant difference between intervention arms for those who began early intervention services.||||.82
71841493|NCT03625115|143192946|EQUIVALENCE|A two-tailed t-test was done to compare the mean Bayley language scores between the groups.||||||0.69|||||||t-test, 2 sided|||||||0.69
71841494|NCT03625115|143192948|EQUIVALENCE|two tailed t-test to compare the means of factor 1 between groups||||||0.858|||||||t-test, 2 sided|||Analysis of factor 1 items from the parent engagement questionnaire. Factor 1 (Buy-in) I am open to getting EI for my child. EI can help my child. EI can teach me new ways to help my child.||||.858
71841495|NCT03625115|143192948|EQUIVALENCE|two tailed t-test to compare the means of factor 2 between groups||||||0.995|||||||t-test, 2 sided|||"Analysis of factor 2 items from the parent engagement questionnaire.~Factor 2 (early intervention consequences):~EI could have negative consequences for my child. Getting EI for my child reflects negatively on me as a parent."||||.995
71841496|NCT03625115|143192948|EQUIVALENCE|two tailed t-test to compare the means of factor 3 between groups||||||0.049|||||||t-test, 2 sided|||"Analysis of factor 3 items from the parent engagement questionnaire.~Factor 3 (Knowledge/Self-Efficacy):~I know how to get EI for my child. I understand how the EI process works. If I have questions about EI, I know who to call. 12. I know my child's rights to EI under the law."||||.049
71841497|NCT03625115|143192949|SUPERIORITY||Odds Ratio (OR)|1.87||||0.02|TWO_SIDED|95.0|1.09|3.21|||Regression, Logistic|||A logistic regression was run to determine if the intervention arm, adjusted for child sex, income, maternal education, and primary care site, was associated with the completion of early intervention referrals for families with an adverse childhood experience survey score of greater than 2.||3.21|1.09|.02
71841498|NCT01236781|143192981|EQUIVALENCE|no margin is assumed.||||||0.46||||||1 degree of freedom;|McNemar|Exact test||"To account for the paired nature of the design, McNemar's test will be used to compare the call-back rates.~H0: assumes no difference between the tests (modalities)"||||0.46
71841499|NCT01236781|143192984|EQUIVALENCE|no equivalence margin||||||0.2188||||||Due to the paired nature of the data an exact McNemar's Test is used|McNemar|Exact test||H0: no difference between the 2 modalities||||0.2188
71675327|NCT01908829|142868079|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|<0.001
71675328|NCT01908829|142868079|SUPERIORITY||LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.1|=|0.019|TWO_SIDED|95.0|0.0|0.5||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.5|0.0|=0.019
71804124|NCT04433767|143107587|OTHER||Intercept|-0.25|STANDARD_ERROR_OF_MEAN|2.43||0.9196|TWO_SIDED|95.0|-5.28|4.78|||Regression, Linear|Adjusted for age, sex, education, and baseline task performance.||||4.78|-5.28|0.9196
71804125|NCT04433767|143107588|OTHER||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.033|TWO_SIDED|95.0|0.01|0.33|||Mixed Models Analysis|Adjusted for age and gender.||||0.33|0.01|0.033
71804126|NCT04433767|143107589|OTHER||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.09||0.041|TWO_SIDED|95.0|0.01|0.35|||Mixed Models Analysis|Adjusted for age and gender.||||0.35|0.01|0.041
71804127|NCT04433767|143107590|OTHER||Slope|-11.13|STANDARD_ERROR_OF_MEAN|3.36||0.001|TWO_SIDED|95.0|-17.81|-4.45|||Mixed Models Analysis|Adjusted for age and gender.||||-4.45|-17.81|0.001
71804128|NCT04433767|143107591|OTHER||Slope|-12.64|STANDARD_ERROR_OF_MEAN|3.68||0.001|TWO_SIDED|95.0|-19.94|-5.33|||Mixed Models Analysis|Adjusted for age and gender.||||-5.33|-19.94|0.001
71804129|NCT04433767|143107592|OTHER||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.15|-0.32|||Mixed Models Analysis|||||-0.32|-1.15|<0.001
71804130|NCT04433767|143107593|OTHER||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.92|-0.34|||Mixed Models Analysis|Adjusted for age and gender.||||-0.34|-0.92|0.001
71804131|NCT04433767|143107594|OTHER||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.65|-0.18|||Mixed Models Analysis|Adjusted for age and gender.||||-0.18|-0.65|<0.001
71804132|NCT04433767|143107595|OTHER||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.35||0.183|TWO_SIDED|95.0|-1.17|0.23|||Mixed Models Analysis|Adjusted for age and gender.||||0.23|-1.17|0.183
71804133|NCT04433767|143107596|OTHER||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.22||0.17|TWO_SIDED|95.0|-0.74|0.13|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.13|-0.74|0.170
71841500|NCT04028284|143192988|OTHER|Two-sided inferential test||||||0.02||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction. The a priori threshold for statistical significance was P \< 0.05 for the primary outcome.|t-test, 2 sided|||||||0.02
71804134|NCT04433767|143107597|OTHER||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.051|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.80|0.00|0.051
71804135|NCT04433767|143107598|OTHER||Slope|-0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|Analyses adjusted for age and gender.||||-0.11|-0.33|<0.001
71804136|NCT04433767|143107599|OTHER||Slope|0.43|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|0.17|0.69|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.69|0.17|0.002
71804137|NCT04433767|143107600|OTHER||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED|95.0|0.21|0.83|||Mixed Models Analysis|Analyses adjusted for age and gender.||||0.83|0.21|0.002
71804138|NCT04433767|143107601|OTHER||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.55||0.876|TWO_SIDED|95.0|-1.05|1.23|||Mixed Models Analysis|Analyses adjusted for age and gender.||||1.23|-1.05|0.876
71804139|NCT00298233|143107602|SUPERIORITY_OR_OTHER|||||||0.42||||||Significance assessed at the 5% level for a two-sided comparison|conditional univariate logistic regressi|analysis stratified by study site||Based on previous studies, assumption was made that 30% of children and 55% of adults treated with standard dose oseltamivir would test negative for virus on day five. This would require a sample size of 242 patients to show a 20% absolute improvement in cessation of viral shedding with 85% power and a two sided α of 0.05. To allow for study withdrawals, the target sample size was set at 300 patients.||||0.42
71804140|NCT00298233|143107603|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|||||||0.54
71804141|NCT00298233|143107604|SUPERIORITY_OR_OTHER|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|Mantel-Haenszel chi-square stratified by study site||||||0.54
71804142|NCT00298233|143107605|SUPERIORITY_OR_OTHER|||||||0.48||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.48
71804143|NCT00298233|143107606|SUPERIORITY_OR_OTHER|||||||0.66||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.66
71804144|NCT00298233|143107607|SUPERIORITY_OR_OTHER|||||||0.58||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis|||||||0.58
71804145|NCT02371369|143107608|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
71804146|NCT02371369|143107609|OTHER|Treatment comparison analysis||||||0.0043|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||0.0043
71841501|NCT04028284|143192989|OTHER|Inferential two-sided test||||||0.31|||||||t-test, 2 sided|||||||0.31
71804147|NCT02371369|143107610|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Fisher's Exact Test|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
71804148|NCT02371369|143107611|OTHER|Treatment comparison analysis||||||0.0019|||||||Mixed effects model for repeated measure|||Treatment comparison between pexidartinib and placebo groups at Week 25||||0.0019
71841502|NCT04028284|143192990|OTHER|Inferential two-sided test||||||0.01||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.01
71841503|NCT04028284|143192991|OTHER|Inferential two-sided test||||||0.03||||||Adjusted for multiple comparisons using the Holm-Bonferroni correction.|t-test, 2 sided|||||||0.03
71894263|NCT01982630|143310436|OTHER||Difference of Least Squares Means|-23.49|||||TWO_SIDED|90.0|-45.65|-1.32|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-1.32|-45.65|
71894264|NCT01982630|143310436|OTHER||Difference of Least Squares Means|-29.76|||||TWO_SIDED|90.0|-51.74|-7.79|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||-7.79|-51.74|
71894265|NCT01982630|143310436|OTHER||Difference of Least Squares Means|6.27|||||TWO_SIDED|90.0|-3.39|15.93|||Linear Mixed Effects Model|Fixed effects for treatment, day and treatment by day interaction, a random effect for participant and baseline 24-hour WMG as a covariate||||15.93|-3.39|
71675329|NCT01908829|142868079|SUPERIORITY||LS Means|0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.3|0.7||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.7|0.3|<0.001
71804149|NCT02371369|143107612|OTHER|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25||||<0.0001
71804150|NCT04307186|143107644|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."|||||<|0.0001||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 1||||<0.0001
71804151|NCT04307186|143107644|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.5775||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 2||||0.5775
71804152|NCT04307186|143107644|OTHER|"McNemar test was used for the exploratory analysis of difference between the percentage of participants greatly prefer/prefer gadoquatrane and greatly prefer/prefer gadobutrol."||||||0.3173||||||P-Value was calculated. p \< 0.05 indicates a difference between the two reads; p \> 0.05 indicates the observed data do not contradict equality.|McNemar|||Reader 3||||0.3173
71804153|NCT04307186|143107645|NON_INFERIORITY|The non-inferiority of gadoquatrane versus gadobutrol was evaluated using CIs based on the t-distribution. A non-inferiority margin of 1 was used, i.e. meaning that a 95% two-sided CI for the mean difference gadoquatrane minus gadobutrol score must exclude the value -1.|Mean Difference (Final Values)|-0.05|||<|0.0001|TWO_SIDED|95.0|-0.24|0.13||P-Value was calculated. Non-inferiority was achieved with a one-sided p-value lower than 0.025.|t-test, 1 sided|||Average reader||0.13|-0.24|<0.0001
71804154|NCT04307186|143107646|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|1.06|1.34|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.34|1.06|
71804155|NCT04307186|143107646|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|0.94|1.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.25|0.94|
71804156|NCT04307186|143107647|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.07|||||TWO_SIDED|95.0|1.87|2.28|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.28|1.87|
71804157|NCT04307186|143107647|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|2.06|||||TWO_SIDED|95.0|1.86|2.25|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||2.25|1.86|
71804158|NCT04307186|143107648|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.27|||||TWO_SIDED|95.0|1.11|1.43|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.43|1.11|
71804159|NCT04307186|143107648|OTHER|95% two-sided CIs based on a t-distribution for the difference of combined pre- and post-contrast minus pre-contrast scores.|Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|1.05|1.32|||||Descriptive comparison of the result following gadobutrol with the result following gadoquatrane.|Average Reader||1.32|1.05|
71804160|NCT01175226|143107650|SUPERIORITY|||||||0.02|||||||ANCOVA|||||||0.020
71804161|NCT02854540|143107651|OTHER||Mean difference (percent)|59.0|STANDARD_DEVIATION|16.0|||TWO_SIDED|||||||||||||
71804162|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.541|STANDARD_ERROR_OF_MEAN|0.156||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.001
71804163|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.161||0.356|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count; a=0.05|Mixed Models Analysis|||Cough or Shortness of Breath||||0.356
71804164|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.163||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.001
71804165|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.141||0.962|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Diarrhea||||0.962
71804166|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.162||0.651|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Difficulty falling or staying asleep||||0.651
71675330|NCT01908829|142868079|SUPERIORITY||LS Means|0.4|STANDARD_ERROR_OF_MEAN|0.1|=|0.001|TWO_SIDED|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||0.6|0.2|=0.001
71804167|NCT02897141|143107676|SUPERIORITY|Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.145||0.23|TWO_SIDED||||||Mixed Models Analysis|||Difficulty remembering||||0.230
71804168|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.126||0.275|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Dizziness||||0.275
71804169|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.175||0.987|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.987
71804170|NCT02897141|143107676|SUPERIORITY||Mean Difference (Net)|-0.275|STANDARD_ERROR_OF_MEAN|0.132||0.037|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fever, chills, sweats||||0.037
71804171|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.101||0.534|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Nausea or vomiting||||0.534
71804172|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.485|STANDARD_ERROR_OF_MEAN|0.157||0.002|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Neuropathy||||0.002
71804173|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.139||0.349|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Skin problems||||0.349
71804174|NCT02897141|143107676|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.107||0.02|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Weight loss or wasting||||0.020
71804175|NCT02897141|143107677|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|7.27||0.001|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Physical functioning scale||||0.001
71804176|NCT02897141|143107677|SUPERIORITY|\[Not specified\]|Median Difference (Final Values)|7.47|STANDARD_ERROR_OF_MEAN|10.02||0.458|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to physical health scale||||0.458
71841504|NCT04028284|143192992|OTHER|Inferential two-sided test||||||0.56|||||||t-test, 2 sided|||||||0.56
71841505|NCT04028284|143192993|OTHER|Inferential two-sided test||||||0.78|||||||t-test, 2 sided|||||||0.78
71804177|NCT02897141|143107677|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|9.91||0.725|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Role limitations due to emotional problems scale||||0.725
71804178|NCT02897141|143107677|SUPERIORITY|\[Not specified\]|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.09||0.807|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|\[Not specified\]|\[Not specified\]|Energy/fatigue scale|\[Not specified\]|||0.807
71804179|NCT02897141|143107677|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|3.73||0.693|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Emotional well-being scale||||0.693
71804180|NCT02897141|143107677|SUPERIORITY||Mean Difference (Final Values)|-8.93|STANDARD_ERROR_OF_MEAN|5.8||0.128|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Social functioning scale||||0.128
71804181|NCT02897141|143107677|SUPERIORITY||Mean Difference (Final Values)|-14.33|STANDARD_ERROR_OF_MEAN|5.18||0.007|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain scale||||0.007
71804182|NCT02897141|143107677|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.93||0.96|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||General health scale||||0.960
71804183|NCT02897141|143107677|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|4.47||0.836|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical health summary scale||||0.836
71804184|NCT02897141|143107677|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|3.6||0.822|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Mental health summary scale||||0.822
71841506|NCT04028284|143192994|OTHER|Inferential two-sided test||||||0.24|||||||Fisher Exact|||||||0.24
71841507|NCT03314688|143193000|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.69
71841508|NCT03314688|143193001|SUPERIORITY|||||||0.33|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.33
71841509|NCT03314688|143193001|SUPERIORITY|||||||0.44|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.44
71841510|NCT03314688|143193001|SUPERIORITY|||||||0.29|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.29
71841511|NCT03314688|143193002|SUPERIORITY|||||||0.69|||||||Chi-squared|||Comparison of Q1: In the past month, how often did you take your aromatase inhibitor (AI)/tamoxifen pills as the doctor prescribed? = 'All the time'||||0.69
71841512|NCT03314688|143193002|SUPERIORITY|||||||0.91|||||||Chi-squared|||Comparison of Q2: In the past month, how often did you forget to take one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.91
71841513|NCT03314688|143193002|SUPERIORITY|||||||0.13|||||||Chi-squared|||Comparison of Q3: In the past month, how often did you decide to skip one or more of your aromatase inhibitor (AI)/tamoxifen pills? = 'Never'||||0.13
71894266|NCT01273818|143310480|SUPERIORITY_OR_OTHER||Fscher exact test|||||0.198|TWO_SIDED||||||Fisher Exact||we did not need an estimation parameter such as odds or relative risk because of our experimental design and hypothesis of this study.|"Comparison Group Selection: our primary outcome is infection positive or negativeso, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is  positive infection frequencies are same for three groups. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%."||||0.198
71894267|NCT03815175|143310481|NON_INFERIORITY|"H0: Death/(MI\[1m-DAPT\]) - Death/(MI \[XIENCE V USA\]) ≥ δ HA: Death/MI(\[1m-DAPT\]) - Death/(MI \[XIENCE V USA: NCT00676520\]) \< δ~Where δ is the non-inferiority margin. The test will be carried out with a one-sided significance level of 0.025 and a non-inferiority margin (δ) of 2.5%."||||||0.0005|||||||Farrington-Manning method|||||||0.0005
71894268|NCT03815175|143310484|SUPERIORITY|"H0: B (1m-DAPT) - B (XIENCE V USA) ≥ 0 HA: B (1m-DAPT) - B (XIENCE V USA: NCT00676520) \< 0~B 1m-DAPT and B XIENCE V USA are bleeding rates (BARC type 2-5) between 1-month and 6-month follow-up for the pooled 1-month DAPT arm and XIENCE V USA historical control, respectively."||||||0.1888|||||||Farrington and Manning method|||||||0.1888
71894269|NCT02513446|143310559|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|176.1|||||TWO_SIDED|90.0|160.5|193.2|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||193.2|160.5|
71894270|NCT02513446|143310560|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|136.5|||||TWO_SIDED|90.0|109.9|169.4|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||169.4|109.9|
71894271|NCT02513446|143310561|SUPERIORITY_OR_OTHER||Adjusted gMean T/R ratio|174.8|||||TWO_SIDED|90.0|159.1|192.0|||ANOVA|Analysis of variance (ANOVA) on the logarithmic scale; Fixed effects: sequence, period and treatment; Random effects: subjects within sequences|Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).|||192.0|159.1|
71894272|NCT01200433|143310592|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.94||||0.011|TWO_SIDED|90.0|0.84|1.05|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.05|0.84|0.011
71804185|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|1.25||0.529|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical Function||||0.529
71841514|NCT05565820|143193074|SUPERIORITY||difference in proportions|-0.335|STANDARD_ERROR_OF_MEAN|0.149||0.025|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 2.246 Cohen's d: .590|Direction of comparison: Vamousse Day 2 proportion of live lice - Nix Day 2 proportion of live lice|"Null hypothesis: At Day 2 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.025
71841515|NCT05565820|143193074|SUPERIORITY||Difference in proportions|0.348|STANDARD_ERROR_OF_MEAN|0.141||0.014|TWO_SIDED|||||Alpha: .05.|Z-test for difference in proportions|Z 2.469 Cohen's d .660|Direction of comparison: Vamousse Day 7 proportion live lice free - Nix Day 7 proportion live lice free|"Null hypothesis: At Day 7 the proportion of lice free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.014
71841516|NCT05565820|143193074|SUPERIORITY||Difference in proportions|0.283|STANDARD_ERROR_OF_MEAN|0.147||0.054|TWO_SIDED|||||Alpha: .05|Z-test for difference in proportions|Z: 1.920 Cohen's d: .513|Vamousse Day 14 proportion live lice free - Nix Day 14 proportion live lice free|"Null hypothesis: At Day 14 the proportion of lice-free subjects in the Vamousse Spray 'n' Go group does not exceed that in the Nix Creme Rinse Lice Treatment group.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."||||.054
71804186|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|1.71|STANDARD_ERROR_OF_MEAN|1.68||0.312|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety||||0.312
71804187|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|1.81||0.841|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression||||0.841
71804188|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.07||0.848|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue||||0.848
71804189|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.03||0.208|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Sleep Disturbance||||0.208
71804190|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|0.72|STANDARD_ERROR_OF_MEAN|2.29||0.754|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Satisfaction with participation in social roles||||0.754
71804191|NCT02897141|143107678|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.66||0.454|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain interference||||0.454
71804192|NCT02897141|143107679|SUPERIORITY||Mean Difference (Final Values)|-2.52|STANDARD_ERROR_OF_MEAN|2.19||0.252|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||||||0.252
71804193|NCT02897141|143107680|SUPERIORITY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.62||0.017|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||CASE adherence index||||0.017
71804194|NCT02897141|143107680|SUPERIORITY||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|5.06||0.338|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Visual analogue scale||||0.338
71841517|NCT05565820|143193075|SUPERIORITY|"To check on the effect of the non-normality of the change proportions, the nonparametric Mann-Whitney test was also performed.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.295|STANDARD_ERROR_OF_MEAN|0.1148||0.02|TWO_SIDED|95.0|0.052|0.537||Alpha = .05 t: 2.567 df (adjusted, see comment below): 16.83 Mann-Whitney Z: 2.830 p(2-tailed) of Mann-Whitney Z: .005 Cohen's d = 1.023|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.83|Direction of comparison: Vamousse prop. reduction in live lice count from Day O - Nix prop. reduction in live lice count from Day O|"Null hypothesis: At Day 2 the mean proportion of decrease from Day 0 in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 2 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.537|.052|.020
71804195|NCT02897141|143107681|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.743|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Overall||||0.743
71804196|NCT02897141|143107681|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.2||0.166|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Quality of life||||0.166
71841518|NCT05565820|143193075|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.182||0.334|TWO_SIDED|95.0|-0.187|0.543||Alpha = .05 t: .976 df: 54 Mann-Whitney Z: 3.021 p(2-tailed) of Mann-Whitney Z: .003 Cohen's d = .294|t-test, 2 sided|Levine's test for violation of equality of variances nonsignificant; no df adjustment necessary.||"Null hypothesis: At Day 7 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 7 change proportions deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on their mean change proportions."||.543|-.187|.334
71841519|NCT05565820|143193075|SUPERIORITY|"The nonparametric Mann-Whitney test was also conducted to check on the effect of the non-normality of the change proportions.~The null hypothesis is one-tailed. However, for consistency with the practice of reporting conservative p-values in clinical studies, the two-tailed p-value will be reported."|Difference between proportions|0.235|STANDARD_ERROR_OF_MEAN|0.1034||0.037|TWO_SIDED|95.0|0.016|0.454||Alpha = .05 t: 2.276 df(adjusted, see comment below): 16.2 Mann-Whitney Z: 2.478 p(2-tailed) of Mann-Whitney Z: .013 Cohen's d = .947|t-test, 2 sided|Degrees of freedom for the t-test were adjusted for inequality of variances between the groups using the Satterthwaite correction: df(adj) = 16.2||"Null hypothesis: At Day 14 the proportion of decrease from baseline in the number of live lice in the Vamousse group does not exceed that in the Nix group.~The distribution of the Day 0 to Day 14 change proportion deviated significantly from normality by the Shapiro-Wilk test for both the Vamousse and combined samples. However, the t-test is robust to such departures from normality for samples of this size and was used to compare the two groups on the mean change proportions."||.454|.016|.037
71841520|NCT05828017|143193079|SUPERIORITY||Mean Difference (Final Values)|1.107|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
71804197|NCT02897141|143107681|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.26||0.899|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived usefulness||||0.899
71804198|NCT02897141|143107681|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.26||0.803|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived ease of use||||0.803
71804199|NCT02897141|143107681|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.48|TWO_SIDED|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||User Control||||0.480
71841521|NCT05828017|143193079|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.015|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference between Variation #1 and the standard curve in terms of mean preference counts per participant.||||0.015
71841522|NCT05828017|143193080|SUPERIORITY||Mean Difference (Final Values)|1.039|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
71841523|NCT05828017|143193080|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.03569|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.03569
71841524|NCT05828017|143193081|SUPERIORITY||Mean Difference (Final Values)|0.365||||0.069|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||0.069
71841525|NCT05828017|143193081|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.6976|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.6976
71804200|NCT05204134|143107693|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71804201|NCT05204134|143107694|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71804202|NCT05204134|143107695|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71804203|NCT05204134|143107696|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71804204|NCT05204134|143107697|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71804205|NCT05204134|143107698|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71804206|NCT05204134|143107699|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804207|NCT05204134|143107700|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804208|NCT05204134|143107701|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804209|NCT05204134|143107702|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.||||<0.001
71804210|NCT05204134|143107703|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804211|NCT05204134|143107704|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804212|NCT05204134|143107705|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804213|NCT05204134|143107706|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804214|NCT05204134|143107707|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804215|NCT05204134|143107708|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804216|NCT05204134|143107709|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804217|NCT05204134|143107710|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804218|NCT05204134|143107711|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71804219|NCT05204134|143107712|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71804220|NCT05204134|143107713|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71804221|NCT05204134|143107714|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71804222|NCT03119766|143107722|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.041|TWO_SIDED|95.0|0.04|1.85|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of GIS scores after 8 weeks of treatment were compared.||1.85|0.04|0.041
71804223|NCT03119766|143107722|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.041|TWO_SIDED|95.0|0.04|1.74|||Mixed Models Analysis||"Fixed factor Treatment and random factor research center were used in mixed model. Difference in mean changes between groups was estimeted."|Mean changes of GIS scores after 8 weeks of treatment were compared. Influence of between center variation was estimated.||1.74|0.04|0.041
71804224|NCT03119766|143107723|SUPERIORITY|||||||0.067|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 1 point.||||0.067
71804225|NCT03119766|143107723|SUPERIORITY|||||||0.029|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 2 points.||||0.029
71804226|NCT03119766|143107723|SUPERIORITY|||||||0.082|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 3 points.||||0.082
71804227|NCT03119766|143107723|SUPERIORITY|||||||0.046|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 4 points.||||0.046
71804228|NCT03119766|143107723|SUPERIORITY|||||||0.111|||||||Fisher Exact|||Test for comparison percentage of patients with reduction ≥ 5 points.||||0.111
71804229|NCT03119766|143107724|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.435|TWO_SIDED|95.0|-0.93|2.15|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of NDI scores after 8 weeks of treatment were compared.||2.15|-0.93|0.435
71804230|NCT03119766|143107725|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.655|TWO_SIDED|95.0|-2.0|1.26|||ANOVA||Results are presented as estimated differences of Least Squares Means according to ANOVA model|Mean changes of SF-36 scores (physical health domain) after 8 weeks of treatment were compared.||1.26|-2.00|0.655
71804231|NCT03119766|143107725|SUPERIORITY||Median Difference (Final Values)|0.65||||0.375|TWO_SIDED|95.0|-0.79|2.1|||ANOVA|||Mean changes of SF-36 scores (mental health domain) after 8 weeks of treatment were compared.||2.10|-0.79|0.375
71804232|NCT03119766|143107726|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71804233|NCT03119766|143107727|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Side effects analysis.||||0.08
71804234|NCT03119766|143107727|SUPERIORITY|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||Therapeutic effect||||0.139
71804235|NCT03119766|143107727|SUPERIORITY|||||||0.251|||||||Wilcoxon (Mann-Whitney)|||Efficacy index analysis.||||0.251
71804236|NCT02034578|143107730|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.953|||||TWO_SIDED|90.0|0.873|1.04||||||B versus A||1.040|0.873|
71804237|NCT02034578|143107730|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.805|||||TWO_SIDED|90.0|0.749|0.865||||||C versus A||0.865|0.749|
71804238|NCT02034578|143107732|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.966|||||TWO_SIDED|90.0|0.924|1.01||||||B versus A||1.010|0.924|
71804239|NCT02034578|143107732|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.919|||||TWO_SIDED|90.0|0.896|0.942||||||C versus A||0.942|0.896|
71675331|NCT01908829|142868080|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
71675332|NCT01908829|142868080|SUPERIORITY||LS Means|-0.2|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
71675333|NCT01908829|142868080|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.2||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.2|-0.4|<0.001
71675334|NCT01908829|142868080|SUPERIORITY||LS Means|-0.3|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p\<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.||-0.1|-0.4|<0.001
71675335|NCT01908829|142868082|SUPERIORITY||Odds Ratio (OR)|1.48|||<|0.001|TWO_SIDED|95.0|1.19|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.19|<0.001
71675336|NCT01908829|142868082|SUPERIORITY||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.25|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.25|<0.001
71675337|NCT01908829|142868082|SUPERIORITY||Odds Ratio (OR)|1.54|||=|0.001|TWO_SIDED|95.0|1.21|1.95||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.95|1.21|=0.001
71804240|NCT02034578|143107733|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.968|||||TWO_SIDED|90.0|0.926|1.011||||||B versus A||1.011|0.926|
71675338|NCT01908829|142868082|SUPERIORITY||Odds Ratio (OR)|1.51|||<|0.001|TWO_SIDED|95.0|1.2|1.9||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.90|1.20|<0.001
71675339|NCT01908829|142868083|SUPERIORITY||Odds Ratio (OR)|1.24|||=|0.119|TWO_SIDED|95.0|0.95|1.63||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.63|0.95|=0.119
71804241|NCT02034578|143107733|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.922|||||TWO_SIDED|90.0|0.899|0.947||||||C versus A||0.947|0.899|
71804242|NCT00489970|143107754|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.41|||||TWO_SIDED|97.5|-1.16|4.17|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.17|-1.16|
71804243|NCT00489970|143107754|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-1.52|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-1.52|
71804244|NCT00489970|143107754|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.32|||||TWO_SIDED|97.5|-3.41|4.15|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.||4.15|-3.41|
71841526|NCT05828017|143193082|SUPERIORITY||Mean Difference (Final Values)|0.876|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.||||<0.001
71841527|NCT05828017|143193082|SUPERIORITY||Mean Difference (Final Values)|0.728||||0.0013|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean preference counts between the standard curve and variation #1.||||0.0013
71841528|NCT05828017|143193083|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.522|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.522
71841529|NCT05828017|143193083|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.27|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts between the standard curve and variation #1.||||0.27
71841530|NCT05828017|143193084|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.28|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.28
71841531|NCT05828017|143193084|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.11|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.11
71841532|NCT05828017|143193085|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.52|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.52
71841533|NCT05828017|143193085|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.26|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.26
71841534|NCT05828017|143193086|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.16|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.16
71841535|NCT05828017|143193086|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.37|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.37
71675340|NCT01908829|142868083|SUPERIORITY||Odds Ratio (OR)|1.56|||<|0.001|TWO_SIDED|95.0|1.23|1.98||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.98|1.23|<0.001
71841536|NCT05828017|143193087|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.08
71841537|NCT05828017|143193087|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.31|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.31
71841538|NCT05828017|143193088|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.21|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.21
71841539|NCT05828017|143193088|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.085|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.085
71841540|NCT05828017|143193089|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.86
71841541|NCT05828017|143193089|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||1
71841542|NCT05828017|143193090|SUPERIORITY||Mean Difference (Final Values)|0.607||||0.009|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.||||0.009
71841543|NCT05828017|143193090|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.61|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.||||0.61
71841544|NCT05828017|143193091|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.11|1.0|||ANOVA|||This is to see if there is a difference in mean SRT50 scores between the standard curve, variation #1, and no preference counts.||1.00|0.11|<0.001
71841545|NCT05828017|143193091|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.357|TWO_SIDED|95.0|0.0|1.0|||ANOVA|||This is to see if there is a difference in SRT 50 scores between the standard curve and variation #1.||1|0|0.357
71841546|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.7|||<|0.01|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2, #3, and #4||||<0.01
71841547|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.01||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #3.||||0.94
71841548|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.014||||0.94|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in most preferred program counts between variations #2 and #4||||0.94
71841549|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.45||||0.017|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2, #3, and #4||||0.017
71804245|NCT00489970|143107754|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||TWO_SIDED|97.5|-3.69|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.||2.07|-3.69|
71804246|NCT00489970|143107756|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.53|||||TWO_SIDED|97.5|1.31|1.79|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||1.79|1.31|
71804247|NCT00489970|143107756|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.62|6.01|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.01|4.62|
71804248|NCT00489970|143107756|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|3.62|||||TWO_SIDED|97.5|3.07|4.25|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||4.25|3.07|
71804249|NCT00489970|143107756|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.64||||||97.5|1.33|2.03|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination||2.03|1.33|
71804250|NCT00489970|143107756|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||TWO_SIDED|97.5|4.37|6.36|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination||6.36|4.37|
71804251|NCT00489970|143107756|NON_INFERIORITY|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|4.47|||||TWO_SIDED|97.5|3.58|5.57|||GMC ratio|The associated CI was derived using the method proposed by G.Y. Zou and A. Donner \[Zou, 2008\]||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination||5.57|3.58|
71804252|NCT00489970|143107757|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-5.91|||||TWO_SIDED|97.5|-14.67|2.85|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.85|-14.67|
71804253|NCT00489970|143107757|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.44|||||TWO_SIDED|97.5|-10.63|7.79|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||7.79|-10.63|
71804254|NCT00489970|143107757|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-8.56|||||TWO_SIDED|97.5|-20.33|2.73|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.||2.73|-20.33|
71675341|NCT01908829|142868083|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.002|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.002
71804255|NCT00489970|143107757|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-11.79|||||TWO_SIDED|97.5|-22.98|0.15|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.||0.15|-22.98|
71841550|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.51||||0.02|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #3.||||0.02
71841551|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.61||||0.006|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #4||||0.006
71841552|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.6|||<|0.0001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2, #3, and #4||||<.0001
71841553|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.38||||0.08|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #3||||0.08
71841554|NCT05828017|143193092|SUPERIORITY||Total Count - Cramer's V|0.5|||<|0.001|TWO_SIDED||||||Chi-squared|||This is to see if there is a difference in the least preferred program counts between variations #2 and #4||||<0.001
71841555|NCT05062330|143193094|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.67|4.13|||Generalized estimating equation|||||4.13|1.67|<0.0001
71841556|NCT03209973|143193117|OTHER||||||<|0.0001||||||1-sided p-value was based on exact test of BGB-A317 versus historical rate of 0.35|Exact Binomial Test|Comparison with historical control values||||||<0.0001
71841557|NCT00429364|143193151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.08
71841558|NCT00429364|143193152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.20
71894273|NCT01200433|143310593|NON_INFERIORITY_OR_EQUIVALENCE|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.99|||<|0.001|TWO_SIDED|90.0|0.96|1.02|||t-test, 1 sided||Dexmedetomidine vs. propofol|||1.02|0.96|< 0.001
71675342|NCT01908829|142868083|SUPERIORITY||Odds Ratio (OR)|1.47|||=|0.001|TWO_SIDED|95.0|1.17|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.17|=0.001
71841559|NCT00429364|143193153|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.15
71841560|NCT00429364|143193154|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.30
71841561|NCT00429364|143193155|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||<0.001
71841562|NCT00429364|143193156|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.002
71841563|NCT00429364|143193157|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|TWO_SIDED|||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis|||||||0.29
71841564|NCT00429364|143193158|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Regression model adjusted for age at study visit.|Mixed Models Analysis|||||||0.96
71841565|NCT00429364|143193159|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
71841566|NCT00429364|143193160|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71841567|NCT00429364|143193161|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
71841568|NCT00429364|143193162|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|||||||0.13
71841569|NCT00429364|143193163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED||||||Mixed Models Analysis|||||||0.82
71841570|NCT00429364|143193164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
71841571|NCT00429364|143193165|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|TWO_SIDED||||||Mixed Models Analysis|||||||0.49
71841572|NCT00429364|143193166|SUPERIORITY_OR_OTHER_LEGACY|||||||0.59|TWO_SIDED||||||Mixed Models Analysis|||||||0.59
71841573|NCT00429364|143193168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Log Rank|||||||0.16
71841574|NCT00429364|143193170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|TWO_SIDED||||||Log Rank|||||||0.13
71841575|NCT00429364|143193172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|||||||0.32
71841576|NCT00429364|143193174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||Log Rank|||||||0.10
71841577|NCT00661141|143193198|SUPERIORITY|||||||0.8727||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.8727
71841578|NCT00661141|143193201|SUPERIORITY|||||||0.0023||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort||||0.0023
71894274|NCT01200433|143310595|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||<|0.001|TWO_SIDED|99.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
71804256|NCT00489970|143107758|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-2.85|||||TWO_SIDED|97.5|-9.09|3.08|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||3.08|-9.09|
71894275|NCT01200433|143310596|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|1.0||||0.91|TWO_SIDED|99.0|0.86|1.18|||Wilcoxon (Mann-Whitney)|||||1.18|0.86|0.91
71804257|NCT00489970|143107758|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-7.05|||||TWO_SIDED|97.5|-13.16|-1.4|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||-1.40|-13.16|
71804258|NCT00489970|143107758|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-10.32|||||TWO_SIDED|97.5|-17.5|-3.38|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||-3.38|-17.50|
71804259|NCT00489970|143107758|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.24|||||TWO_SIDED|97.5|-10.03|5.57|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.||5.57|-10.03|
71804260|NCT00489970|143107758|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|4.01|||||TWO_SIDED|97.5|-2.38|8.66|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.||8.66|-2.38|
71841579|NCT00661141|143193201|SUPERIORITY|||||||0.386||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort||||0.386
71841580|NCT00661141|143193201|SUPERIORITY|||||||0.0006||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg, 5.0 mg/kg||||0.0006
71841581|NCT00661141|143193201|SUPERIORITY|||||||0.0154||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||3.0 mg/kg, 5.0 mg/kg||||0.0154
71841582|NCT00661141|143193208|SUPERIORITY||ratio of parameter means|115.57|||||TWO_SIDED|90.0|90.45|147.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||147.67|90.45|
71841583|NCT00661141|143193208|SUPERIORITY||ratio of parameter means|126.05|||||TWO_SIDED|90.0|101.94|155.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||155.87|101.94|
71841584|NCT00661141|143193208|SUPERIORITY||ratio of parameter means|137.58|||||TWO_SIDED|90.0|115.66|163.65|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.65|115.66|
71894276|NCT01200433|143310598|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.9||||0.02|TWO_SIDED|99.0|-4.1|0.2|||Wilcoxon (Mann-Whitney)|||||0.2|-4.1|0.02
71894277|NCT01200433|143310599|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||>|0.99|TWO_SIDED|99.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|>0.99
71894278|NCT00955110|143310648|SUPERIORITY_OR_OTHER||Least Square Means Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-41.6|-16.0||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-16.0|-41.6|<0.001
71841585|NCT00661141|143193208|SUPERIORITY||ratio of parameter means|82.4|||||TWO_SIDED|90.0|62.83|108.07|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||108.07|62.83|
71804261|NCT00489970|143107758|NON_INFERIORITY|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate \[a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)\] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response|-4.76|||||TWO_SIDED|97.5|-14.53|3.18|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.||3.18|-14.53|
71804262|NCT01159938|143107797|SUPERIORITY_OR_OTHER||LS mean difference|0.26||||0.617|TWO_SIDED|95.0|-0.78|1.3||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.30|-0.78|0.617
71804263|NCT01159938|143107797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.732|TWO_SIDED|95.0|-1.23|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.23|0.732
71804264|NCT01159938|143107797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27||||0.715|TWO_SIDED|95.0|-1.2|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.73|-1.20|0.715
71841586|NCT00661141|143193208|SUPERIORITY||ratio of parameter means|115.25|||||TWO_SIDED|90.0|91.19|145.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||145.67|91.19|
71675343|NCT01908829|142868084|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.305|TWO_SIDED|95.0|0.88|1.5||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.50|0.88|=0.305
71804265|NCT01159938|143107797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.177|TWO_SIDED|95.0|-0.85|0.16||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.16|-0.85|0.177
71804266|NCT01159938|143107797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.579|TWO_SIDED|95.0|-0.94|0.53||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.53|-0.94|0.579
71804267|NCT01159938|143107797|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.49||||0.167|TWO_SIDED|95.0|-1.19|0.21||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||0.21|-1.19|0.167
71804268|NCT01159938|143107798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.676|TWO_SIDED|95.0|-1.1|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.10|0.676
71804269|NCT01159938|143107798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.957|TWO_SIDED|95.0|-1.27|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-1.27|0.957
71804270|NCT01159938|143107798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.513|TWO_SIDED|95.0|-1.68|0.85||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.85|-1.68|0.513
71804271|NCT01159938|143107798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.623|TWO_SIDED|95.0|-0.47|0.28||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.28|-0.47|0.623
71804272|NCT01159938|143107798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.916|TWO_SIDED|95.0|-0.51|0.57||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.57|-0.51|0.916
71841587|NCT00661141|143193208|SUPERIORITY||ratio of parameter means|112.64|||||TWO_SIDED|90.0|96.14|131.98|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||131.98|96.14|
71894279|NCT00955110|143310648|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-50.5|||<|0.001|TWO_SIDED|95.0|-63.4|-37.5||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||-37.5|-63.4|<0.001
71894280|NCT00955110|143310648|SUPERIORITY_OR_OTHER||Least Square Mean Difference|5.5||||0.395|TWO_SIDED|95.0|-7.3|18.3||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||18.3|-7.3|0.395
71804273|NCT01159938|143107798|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.413|TWO_SIDED|95.0|-0.73|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.73|0.413
71804274|NCT01159938|143107799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.724|TWO_SIDED|95.0|-0.94|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.34|-0.94|0.724
71804275|NCT01159938|143107799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.57||||0.479|TWO_SIDED|95.0|-1.05|2.2||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||2.20|-1.05|0.479
71804276|NCT01159938|143107799|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18||||0.825|TWO_SIDED|95.0|-1.76|1.41||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA|||||1.41|-1.76|0.825
71804277|NCT01159938|143107799|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.378|TWO_SIDED|95.0|-0.65|0.25||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.25|-0.65|0.378
71804278|NCT01159938|143107799|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.553|TWO_SIDED|95.0|-0.84|0.46||The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.46|-0.84|0.553
71804279|NCT01159938|143107799|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.512|TWO_SIDED|95.0|-0.83|0.42||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.42|-0.83|0.512
71804280|NCT01159938|143107800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.466|TWO_SIDED|95.0|-1.09|0.51||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.51|-1.09|0.466
71804281|NCT01159938|143107800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44||||0.449|TWO_SIDED|95.0|-1.6|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.72|-1.60|0.449
71804282|NCT01159938|143107800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.15||||0.792|TWO_SIDED|95.0|-1.25|0.96||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.96|-1.25|0.792
71804283|NCT01159938|143107800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16||||0.493|TWO_SIDED|95.0|-0.63|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-0.63|0.493
71804284|NCT01159938|143107800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.091|TWO_SIDED|95.0|-1.25|0.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.10|-1.25|0.091
71804285|NCT01159938|143107800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.425|TWO_SIDED|95.0|-0.39|0.9||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.90|-0.39|0.425
71804286|NCT01159938|143107801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.275|TWO_SIDED|95.0|-1.36|0.4||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.40|-1.36|0.275
71804287|NCT01159938|143107801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.784||95.0|-1.44|1.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||1.10|-1.44|0.784
71804288|NCT01159938|143107801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79||||0.197|TWO_SIDED|95.0|-2.01|0.43||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.43|-2.01|0.197
71804289|NCT01159938|143107801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.122|TWO_SIDED|95.0|-0.9|0.11||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.11|-0.90|0.122
71804290|NCT01159938|143107801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43||||0.246|TWO_SIDED|95.0|-1.16|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.31|-1.16|0.246
71804291|NCT01159938|143107801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37||||0.298|TWO_SIDED|95.0|-1.06|0.33||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA|||||0.33|-1.06|0.298
71804292|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.49||||0.024|TWO_SIDED|95.0|-6.5|-0.48||P-value is for the Least Square (LS) mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.||||-0.48|-6.50|0.024
71804293|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.859|TWO_SIDED|95.0|-2.59|3.09||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||3.09|-2.59|0.859
71804294|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.19||||0.155|TWO_SIDED|95.0|-5.25|0.87||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.87|-5.25|0.155
71804295|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58||||0.685|TWO_SIDED|95.0|-3.46|2.3||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.30|-3.46|0.685
71804296|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.84||||0.292|TWO_SIDED|95.0|-5.33|1.64||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||1.64|-5.33|0.292
71804297|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|2.04||||0.216|TWO_SIDED|95.0|-1.25|5.33||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||5.33|-1.25|0.216
71804298|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.87||||0.065|TWO_SIDED|95.0|-5.92|0.18||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.18|-5.92|0.065
71804299|NCT01159938|143107802|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.954|TWO_SIDED|95.0|-2.96|2.8||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||2.80|-2.96|0.954
71804300|NCT01159938|143107803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.905|TWO_SIDED|95.0|-0.31|0.27||P-value is for Least Square (LS) mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.27|-0.31|0.905
71804301|NCT01159938|143107803|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42||||0.004|TWO_SIDED|95.0|0.14|0.69||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.69|0.14|0.004
71804302|NCT01159938|143107803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.584|TWO_SIDED|95.0|-0.41|0.23||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.23|-0.41|0.584
71804303|NCT01159938|143107803|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.436|TWO_SIDED|95.0|-0.19|0.44||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.||||0.44|-0.19|0.436
71804304|NCT00086346|143107844|SUPERIORITY_OR_OTHER|||||||0.342|||||||Rank ANCOVA|||||||0.342
71804305|NCT00086346|143107845|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|||Comparison between treatment groups of percentages of patients with biopsy-confirmed acute rejection.||||0.017
71804306|NCT00086346|143107846|SUPERIORITY_OR_OTHER||||||>|0.05|||||||1 way ANOVA, two sided|||||||>0.05
71804307|NCT00086346|143107847|NON_INFERIORITY_OR_EQUIVALENCE|The a priori criterion for declaring non-inferiority was a lower bound of the 95% confidence interval (CI) having a ≥ 5% difference in graft loss. -5.2 is \< 5 % difference.|Mean Difference (Net)|-1.2||||||95.0|-5.2|2.8|||||Weighted difference in percentage of graft loss: (CNI% minus SRL%); negative values are favorable to CNI group|||2.8|-5.2|
71804308|NCT01303627|143107848|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of \<0.05 was considered statistically significant.|Chi-squared|||The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).||||<0.05
71804309|NCT01054820|143107867|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.||||<0.0001
71841588|NCT00661141|143193211|SUPERIORITY||ratio of parameter means|139.63|||||TWO_SIDED|90.0|92.18|211.51|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||211.51|92.18|
71841589|NCT00661141|143193211|SUPERIORITY||ratio of parameter means|120.76|||||TWO_SIDED|90.0|108.8|134.03|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||134.03|108.80|
71841590|NCT00661141|143193211|SUPERIORITY||ratio of parameter means|143.39|||||TWO_SIDED|90.0|107.72|190.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||190.87|107.72|
71841591|NCT00661141|143193211|SUPERIORITY||ratio of parameter means|103.13|||||TWO_SIDED|90.0|84.35|126.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||126.10|84.35|
71841592|NCT00661141|143193211|SUPERIORITY||ratio of parameter means|123.17|||||TWO_SIDED|90.0|108.61|139.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||139.67|108.61|
71841593|NCT00661141|143193211|SUPERIORITY||ratio of parameter means|137.17|||||TWO_SIDED|90.0|123.3|152.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||152.59|123.30|
71841594|NCT00661141|143193213|SUPERIORITY||ratio of parameter means|121.81|||||TWO_SIDED|90.0|108.42|136.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||136.84|108.42|
71804310|NCT01054820|143107868|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|McNemar|||||||<0.0001
71804311|NCT01054820|143107869|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
71804312|NCT01054820|143107870|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
71804313|NCT01054820|143107871|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
71804314|NCT01054820|143107872|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
71841595|NCT00661141|143193213|SUPERIORITY||ratio of parameter means|123.7|||||TWO_SIDED|90.0|93.55|163.56|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||163.56|93.55|
71804315|NCT01054820|143107875|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||||||<0.0001
71804316|NCT01154166|143107881|SUPERIORITY_OR_OTHER||Adjusted mean for treatment difference|-1.76|||<|0.001|TWO_SIDED|95.0|-2.27|-1.26|||ANCOVA||The estimated value indicates the treatment difference for the adjusted mean for Ropinirole PR and placebo.|||-1.26|-2.27|<0.001
71841596|NCT00661141|143193213|SUPERIORITY||ratio of parameter means|150.33|||||TWO_SIDED|90.0|93.14|242.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||242.63|93.14|
71841597|NCT00661141|143193213|SUPERIORITY||ratio of parameter means|122.83|||||TWO_SIDED|90.0|82.45|183.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analysis for Cohort 3 where all available data were included.||183.00|82.45|
71841598|NCT00661141|143193219|SUPERIORITY||ratio of parameter means|69.13|||||TWO_SIDED|90.0|48.88|97.78|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||97.78|48.88|
71804317|NCT02019719|143107919|SUPERIORITY_OR_OTHER||E0 (g/dL)|-1.37|||||TWO_SIDED|95.0|-1.72|-1.03|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-1.03|-1.72|
71804318|NCT02019719|143107919|SUPERIORITY_OR_OTHER||ED50 (mg)|21.88|||||TWO_SIDED|95.0|9.99|42.64|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||42.64|9.99|
71804319|NCT02019719|143107919|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.88|||||TWO_SIDED|95.0|3.2|8.61|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.61|3.20|
71804320|NCT02019719|143107919|SUPERIORITY_OR_OTHER||Gamma|1.13|||||TWO_SIDED|95.0|0.7|1.68|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.68|0.70|
71804321|NCT02019719|143107919|SUPERIORITY_OR_OTHER||Var|0.66|||||TWO_SIDED|95.0|0.5|0.88|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||0.88|0.50|
71804322|NCT02019719|143107919|SUPERIORITY_OR_OTHER||MED (mg)|1.98|||||TWO_SIDED|95.0|0.75|3.41|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||3.41|0.75|
71804323|NCT02019719|143107919|SUPERIORITY_OR_OTHER||TD (mg)|3.9|||||TWO_SIDED|95.0|2.2|5.63|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.63|2.20|
71804324|NCT02019719|143107919|SUPERIORITY_OR_OTHER||MAD (mg)|8.65|||||TWO_SIDED|95.0|6.51|11.44|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||11.44|6.51|
71804325|NCT04535037|143107937|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) of group GMC ratio (Infanrix Hexa over Vaxelis group) was above 0.5.|Adjusted GMC Ratio|0.917|||||TWO_SIDED|95.0|0.71|1.185||||The 95% CI for GMC ratio derived from an ANOVA model on log10 transformed concentration was used. GMC was adjusted for DTPA vaccination of the mother.||To demonstrate that the Haemophilus influenzae type b(Hib) response of Infanrix Hexa Group is non-inferior to the Vaxelis Group in terms of anti-PRP GMCs, 1 month post-booster vaccination.||1.185|0.710|
71804326|NCT04535037|143107938|NON_INFERIORITY|Non-inferiority was demonstrated if the non inferiority of anti-PRP GMC ratio was met and the LL of the 2 sided 95% CI on group difference in the percentage (Infanrix Hexa over Vaxelis group) was more than -10%.|Difference in Percentage|-6.3|||||TWO_SIDED|95.0|-14.1|1.49||||The 2 sided 95% CI of group difference in seroconversion rate (Inv\_group minus Com\_group) was computed based on Miettinen and Nurminen method.||To demonstrate that the Hib response in Infanrix Hexa group is non-inferior to Vaxelis Group in terms of percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL, 1 month post-booster vaccination.||1.49|-14.10|
71804327|NCT02731131|143107946|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
71804328|NCT02731131|143107948|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||0.22
71804329|NCT02731131|143107949|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
71804330|NCT02731131|143107950|SUPERIORITY_OR_OTHER|||||||0.3|||||||Fisher Exact|||||||0.30
71804331|NCT02731131|143107951|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71804332|NCT00562159|143107980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|||=|0.005|TWO_SIDED|95.0|-2.22|-0.4|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.40|-2.22|=0.005
71804333|NCT00562159|143107981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|||=|0.015|TWO_SIDED|95.0|-1.46|-0.26|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.26|-1.46|=0.015
71804334|NCT00562159|143107982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|||=|0.084|TWO_SIDED|95.0|-0.96|0.06|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.06|-0.96|=0.084
71841599|NCT00661141|143193219|SUPERIORITY||ratio of parameter means|124.46|||||TWO_SIDED|90.0|88.77|174.5|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||174.50|88.77|
71804335|NCT00562159|143107983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||=|0.022|TWO_SIDED|95.0|-0.48|-0.05|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.05|-0.48|=0.022
71804336|NCT02417246|143107984|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|45.1|STANDARD_DEVIATION|222.2||0.3|TWO_SIDED|95.0|-41.1|131.2|||t-test, 2 sided|Average AUC from 0 to 24 hours (0-24) for patients on the 50mg dose of brand name metoprolol ER and Generic B were compared by a paired t-test (n=28)||||131.2|-41.1|0.3
71804337|NCT02417246|143107984|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic B to brand name metoprolol ER falls within 0.8 to 1.25|Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||The analysis included a total of 20 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients.||||||0.95|0.76|
71804338|NCT02417246|143107984|EQUIVALENCE|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have \>80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|176.5||0.8|TWO_SIDED|95.0|-60.0|74.3|||t-test, 2 sided|Average AUC0-24 for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||74.3|-60.0|0.8
71804339|NCT02417246|143107984|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|1.01||This analysis included 21 individuals who were administered brand name metoprolol ER and Generic A, which is less than the initial plan of including 38 patients.||||||1.01|0.86|
71804340|NCT02417246|143107985|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|10.7||0.2|TWO_SIDED|95.0|-1.5|6.6|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic B were compared using a paired t-test (n=29)||||6.6|-1.5|0.2
71804341|NCT02417246|143107985|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic B to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.79|0.95||The analysis included a total of 29 patients on Generic B and brand name metoprolol ER, which is less than the initial plan of including 38 patients||||||0.95|0.79|
71841600|NCT00661141|143193219|SUPERIORITY||ratio of parameter means|105.31|||||TWO_SIDED|90.0|89.24|124.27|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||124.27|89.24|
71841601|NCT00661141|143193219|SUPERIORITY||ratio of parameter means|88.6|||||TWO_SIDED|90.0|56.66|138.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||138.54|56.66|
71841602|NCT00661141|143193219|SUPERIORITY||ratio of parameter means|70.77|||||TWO_SIDED|90.0|34.16|146.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||146.59|34.16|
71804342|NCT02417246|143107985|EQUIVALENCE|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have \>80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|12.6||0.3|TWO_SIDED|95.0|-7.3|2.3|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)||||2.3|-7.3|0.3
71804343|NCT02417246|143107985|EQUIVALENCE|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|1.12|||||TWO_SIDED|90.0|1.02|1.23||The analysis included a total of 29 patients on Generic A and brand name metoprolol ER, which is less than a pre-planned sample size of 38.||||||1.23|1.02|
71804344|NCT02417246|143107986|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic B, adjusting for quartile, (quartile\*med) interaction, and treatment assignment.|Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0858|TWO_SIDED||||||Mixed Models Analysis|||||||0.0858
71804345|NCT02417246|143107986|EQUIVALENCE|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic A, adjusting for quartile,(quartile\*med) interaction, and treatment assignment.|Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0168|TWO_SIDED||||||Mixed Models Analysis||p for medication\*quartile interaction considered significant if p\<0.025.|||||0.0168
71804346|NCT02417246|143107987|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory systolic blood pressure (SBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-2.39||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||0.203
71804347|NCT02417246|143107987|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory diastolic blood pressure (DBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-0.543||||0.671|TWO_SIDED||||||Mixed Models Analysis|||||||0.671
71804348|NCT02417246|143107987|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory SBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.371||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.200
71841603|NCT00661141|143193219|SUPERIORITY||ratio of parameter means|86.04|||||TWO_SIDED|90.0|55.78|132.73|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||132.73|55.78|
71841604|NCT00661141|143193222|SUPERIORITY||ratio of parameter means|90.2|||||TWO_SIDED|90.0|69.54|117.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||117.00|69.54|
71841605|NCT00661141|143193222|SUPERIORITY||ratio of parameter means|112.28|||||TWO_SIDED|90.0|103.72|121.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||121.54|103.72|
71841606|NCT00661141|143193222|SUPERIORITY||ratio of parameter means|106.08|||||TWO_SIDED|90.0|96.81|116.24|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||116.24|96.81|
71841607|NCT00661141|143193222|SUPERIORITY||ratio of parameter means|104.12|||||TWO_SIDED|90.0|83.5|129.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||129.84|83.50|
71804349|NCT02417246|143107987|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory DBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.329||||0.068|TWO_SIDED||||||Mixed Models Analysis|||||||0.068
71841608|NCT00661141|143193222|SUPERIORITY||ratio of parameter means|100.41|||||TWO_SIDED|90.0|77.86|129.49|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||129.49|77.86|
71804350|NCT02417246|143107988|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|1.233||||0.333|TWO_SIDED||||||Mixed Models Analysis|||||||0.333
71804351|NCT02417246|143107988|EQUIVALENCE|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|1.134||||0.368|TWO_SIDED||||||Mixed Models Analysis|||||||0.368
71804352|NCT04321460|143108006|SUPERIORITY||Odds Ratio (OR)|4.564||||0.007|TWO_SIDED|95.0|1.66|16.039|||Wilcoxon (Mann-Whitney)|||||16.039|1.66|0.007
71804353|NCT04321460|143108007|SUPERIORITY||Odds Ratio (OR)|4.716||||0.002|TWO_SIDED|95.0|1.898|14.268|||Wilcoxon (Mann-Whitney)|||||14.268|1.898|0.002
71804354|NCT04495712|143108020|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
71804355|NCT04495712|143108021|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
71804356|NCT04495712|143108022|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
71804357|NCT02162810|143108026|OTHER||||||<|0.62|||||||Fisher Exact|||Due to the number of 0 cell counts, it is not possible to do individual statistics for each complication, so we looked at the incidence of complications overall between the two arms.||||<.62
71804358|NCT02162810|143108027|OTHER||||||<|0.61|||||||Fisher Exact|||||||<0.61
71804359|NCT02162810|143108028|OTHER||||||<|0.87|||||||Fisher Exact|||Improvement category: Chordee with Degloving||||<.87
71804360|NCT02162810|143108028|OTHER||||||<|0.64|||||||Fisher Exact|||Improvement category: Ventral Chordee||||<.64
71804361|NCT02162810|143108028|OTHER||||||<|0.85|||||||Fisher Exact|||Improvement category: Chordee with Plication||||<.85
71804362|NCT00706121|143108034|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.96||||0.96|TWO_SIDED|95.0|0.9|1.02|||Log binomial regression|||||1.02|0.9|0.96
71804363|NCT00706121|143108035|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.92||||0.32|TWO_SIDED|95.0|0.78|1.08|||Log binomial regression|||||1.08|0.78|0.32
71804364|NCT00706121|143108037|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.91||||0.24|TWO_SIDED|95.0|0.77|1.07|||Log binomial regression|||||1.07|0.77|0.24
71804365|NCT00706121|143108038|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.38|TWO_SIDED|95.0|0.96|1.1|||Log binomial regression|||||1.10|0.96|0.38
71804366|NCT01308749|143108043|OTHER||||||||||||||||||No analyses were completed, this is descriptive only and is an absolute value (number of participants).|||
71804367|NCT01308749|143108047|EQUIVALENCE|Within group test of difference using t-scores adjusted by baseline score, no correction for multiple comparisons, nonparametric model||||||0.023|||||||t-test, 2 sided|||||||0.023
71804368|NCT01308749|143108049|EQUIVALENCE|t-test between groups||||||0.23|||||||t-test, 2 sided|no adjustment for multiple comparison. non parametric||||||0.23
71804369|NCT02223390|143108096|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.||||||0.08||||||A priori threshold for statistical significance was p\<.05. The p-value presented corresponds to the time by condition interaction parameter.|Mixed Models Analysis|To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.||Statistical analyses reported below is for PCL - Total at 3 months.||||0.08
71804370|NCT02223390|143108097|SUPERIORITY|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.||||||0.05||||||A priori threshold was defined as p\<0.05.|Chi-squared|||||||0.05
71804371|NCT01666002|143108104|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71804372|NCT01666002|143108105|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71804373|NCT03447769|143108150|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.258|TWO_SIDED|95.0|0.78|1.14||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|||1.14|0.78|0.258
71804374|NCT03447769|143108155|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.676|TWO_SIDED|95.0|0.76|1.58||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 \<1%||1.58|0.76|0.676
71804375|NCT03447769|143108155|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.036|TWO_SIDED|95.0|0.34|1.05||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥1% and \<49%||1.05|0.34|0.036
71804376|NCT03447769|143108155|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.823|TWO_SIDED|95.0|0.73|2.43||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test|PD-L1 ≥50%||2.43|0.73|0.823
71804377|NCT03447769|143108156|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.872|TWO_SIDED|95.0|0.87|1.72||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 \< median||1.72|0.87|0.872
71804378|NCT03447769|143108156|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.303|TWO_SIDED|95.0|0.62|1.33||1-sided p-value|Stratified log-rank test||The HR for DFS was calculated, along with its 95% confidence interval, from a stratified Cox model using the same stratification factors as those for the log-rank test.|CD8 ≥ median||1.33|0.62|0.303
71804379|NCT01343407|143108177|OTHER||Difference in Least Squares Means (LSM)|-22.2||||0.011|TWO_SIDED|90.0|-35.7|-8.7|||Linear mixed effects model|||||-8.7|-35.7|0.011
71804380|NCT01343407|143108177|OTHER||Difference in LSM|-18.9||||0.023|TWO_SIDED|90.0|-32.1|-5.8|||Linear mixed effects model|||||-5.8|-32.1|0.023
71804381|NCT01343407|143108178|OTHER||LS Mean Ratio (LSMR)|0.48||||0.006|TWO_SIDED|90.0|0.32|0.72|||Linear mixed effects model||||% Inhibition: 52.2 (90% CI: 28.3, 68.2). The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.72|0.32|0.006
71804382|NCT01343407|143108178|OTHER||LS Mean Ratio (LSMR)|0.58||||0.012|TWO_SIDED|90.0|0.41|0.81|||Linear mixed effects model||||% Inhibition: 42.4 (90% CI: 19.3, 58.8) The % Inhibition of FEV1\*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100\*(1-LSMR).|0.81|0.41|0.012
71804383|NCT01343407|143108179|OTHER||LSM Difference|85.84|||<|0.001|TWO_SIDED|90.0|65.3|106.4|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||106.4|65.3|<0.001
71804384|NCT01343407|143108179|OTHER||LSM Difference|83.29|||<|0.001|TWO_SIDED|90.0|63.9|102.7|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough|||102.7|63.9|<0.001
71804385|NCT03029208|143108252|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|Least square (LS) mean difference|-0.1|||||TWO_SIDED|95.0|-0.34|0.14|||||An ANCOVA model including randomization stratification factors Baseline Hgb and treatment was performed to obtain a point estimate and two-sided 95% CI for the treatment difference (daprodustat-darbepoetin alfa).|||0.14|-0.34|
71841609|NCT00661141|143193222|SUPERIORITY||ratio of parameter means|94.7|||||TWO_SIDED|90.0|82.7|108.42|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||108.42|82.70|
71675344|NCT01908829|142868084|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.014|TWO_SIDED|95.0|1.06|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.06|=0.014
71675345|NCT01908829|142868084|SUPERIORITY||Odds Ratio (OR)|1.37|||=|0.012|TWO_SIDED|95.0|1.07|1.76||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.76|1.07|=0.012
71675346|NCT01908829|142868084|SUPERIORITY||Odds Ratio (OR)|1.29|||=|0.036|TWO_SIDED|95.0|1.02|1.64||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.64|1.02|=0.036
71675347|NCT01908829|142868085|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.001|TWO_SIDED|95.0|1.18|1.88||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.88|1.18|=0.001
71675348|NCT01908829|142868085|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.31|2.18||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.18|1.31|<0.001
71675349|NCT01908829|142868085|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.47|2.61||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.61|1.47|<0.001
71804386|NCT03029208|143108253|SUPERIORITY||LS mean difference|19.4||||0.8949|TWO_SIDED|95.0|-11.0|49.9|||ANCOVA||An ANCOVA model was used to compare the difference in this average monthly IV iron dose between arms, including factors for Baseline dose, treatment and the randomization stratification factors.|||49.9|-11.0|0.8949
71804387|NCT03029208|143108254|SUPERIORITY||LS mean difference|3.23||||0.8168|TWO_SIDED|95.0|-3.82|10.27|||Mixed model repeated measures (MMRM)||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||10.27|-3.82|0.8168
71841610|NCT00661141|143193224|SUPERIORITY||ratio of parameter means|94.15|||||TWO_SIDED|90.0|78.01|1113.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|||1113.63|78.01|
71675350|NCT01908829|142868085|SUPERIORITY||Odds Ratio (OR)|1.75|||<|0.001|TWO_SIDED|95.0|1.34|2.3||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.30|1.34|<0.001
71804388|NCT03029208|143108254|SUPERIORITY||LS mean difference|4.21||||0.9793|TWO_SIDED|95.0|0.17|8.26|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.26|0.17|0.9793
71841611|NCT00661141|143193224|SUPERIORITY||ratio of parameter means|107.05|||||TWO_SIDED|90.0|87.42|131.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.||131.10|87.42|
71675351|NCT01908829|142868086|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.003|TWO_SIDED|95.0|1.14|1.82||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.82|1.14|=0.003
71675352|NCT01908829|142868086|SUPERIORITY||Odds Ratio (OR)|1.51|||=|0.001|TWO_SIDED|95.0|1.18|1.93||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.93|1.18|=0.001
71804389|NCT03029208|143108254|SUPERIORITY||LS mean difference|4.1||||0.9597|TWO_SIDED|95.0|-0.51|8.7|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||8.70|-0.51|0.9597
71804390|NCT03029208|143108255|SUPERIORITY||LS mean difference|-0.09||||0.484|TWO_SIDED|95.0|-4.72|4.53|||ANCOVA||The difference in change from Baseline in SBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.53|-4.72|0.4840
71841612|NCT00661141|143193224|SUPERIORITY||ratio of parameter means|97.9|||||TWO_SIDED|90.0|84.84|112.97|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.||112.97|84.84|
71804391|NCT03029208|143108255|SUPERIORITY||LS mean difference|1.99||||0.9156|TWO_SIDED|95.0|-0.85|4.82|||ANCOVA||The difference in change from Baseline in DBP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.82|-0.85|0.9156
71804392|NCT03029208|143108255|SUPERIORITY||LS mean difference|1.29||||0.7966|TWO_SIDED|95.0|-1.76|4.33|||ANCOVA||The difference in change from Baseline in MAP at the derived end of treatment was analyzed with an ANCOVA model including terms for treatment, prognostic randomization stratification factors.|||4.33|-1.76|0.7966
71804393|NCT03029208|143108256|SUPERIORITY||Ratio of exacerbation rate|1.01||||0.5174|TWO_SIDED|95.0|0.73|1.39|||Negative binomial model||Model estimated exacerbation rates, ratio of model estimated exacerbation rates and CIs were estimated using a negative binomial model for the treatment group comparison.|||1.39|0.73|0.5174
71804394|NCT03029208|143108258|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.04|||||TWO_SIDED|95.0|-0.29|0.36|||||The difference in change from Baseline in post-randomization Hgb at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||0.36|-0.29|
71804395|NCT03029208|143108259|SUPERIORITY||Difference in response rate|-0.8||||0.5411|TWO_SIDED|95.0|-12.2|10.7|||Cochran-Mantel-Haenszel||A Cochran-Mantel-Haenszel (CMH) test adjusted for treatment and randomization stratification factors were used to compare the number of responders between the treatment groups.|||10.7|-12.2|0.5411
71804396|NCT03029208|143108260|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|2.05|||||TWO_SIDED|95.0|-4.45|11.27|||||Hodges-Lehmann Estimate of Treatment Difference has been reported.|||11.27|-4.45|
71804397|NCT03029208|143108261|SUPERIORITY||Probability|0.54||||0.1538|TWO_SIDED|95.0|0.46|0.61|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.61|0.46|0.1538
71804398|NCT03029208|143108262|OTHER||Hazard Ratio (HR)|1.06||||0.5348|TWO_SIDED|95.0|0.31|3.66|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, dialysis type and dialysis start manner.|||3.66|0.31|0.5348
71804399|NCT03029208|143108263|SUPERIORITY||LS mean difference|-0.39||||0.6641|TWO_SIDED|95.0|-2.22|1.44|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.44|-2.22|0.6641
71804400|NCT03029208|143108263|SUPERIORITY||LS mean difference|1.13||||0.103|TWO_SIDED|95.0|-0.63|2.89|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.89|-0.63|0.1030
71804401|NCT03029208|143108263|SUPERIORITY||LS mean difference|0.49||||0.3157|TWO_SIDED|95.0|-1.51|2.48|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.48|-1.51|0.3157
71804402|NCT03029208|143108263|SUPERIORITY||LS mean difference|-1.31||||0.8855|TWO_SIDED|95.0|-3.46|0.84|||MMRM||SF-36 HRQoL PCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.84|-3.46|0.8855
71804403|NCT03029208|143108264|SUPERIORITY||LS mean difference|-0.67||||0.7146|TWO_SIDED|95.0|-2.99|1.66|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.66|-2.99|0.7146
71804404|NCT03029208|143108264|SUPERIORITY||LS mean difference|-1.53||||0.905|TWO_SIDED|95.0|-3.82|0.76|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.76|-3.82|0.9050
71894281|NCT00955110|143310648|SUPERIORITY_OR_OTHER||Least Square Mean Difference|38.0|||<|0.001|TWO_SIDED|95.0|25.2|50.8||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||50.8|25.2|<0.001
71804405|NCT03029208|143108264|SUPERIORITY||LS mean difference|-0.32||||0.595|TWO_SIDED|95.0|-2.91|2.28|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.28|-2.91|0.5950
71804406|NCT03029208|143108264|SUPERIORITY||LS mean difference|-0.23||||0.5619|TWO_SIDED|95.0|-3.17|2.7|||MMRM||SF-36 HRQoL MCS domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.70|-3.17|0.5619
71804407|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.14||||0.4523|TWO_SIDED|95.0|-2.21|2.49|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.49|-2.21|0.4523
71804408|NCT03029208|143108265|SUPERIORITY||LS mean difference|-0.07||||0.5222|TWO_SIDED|95.0|-2.57|2.43|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.43|-2.57|0.5222
71804409|NCT03029208|143108265|SUPERIORITY||LS mean difference|2.33||||0.044|TWO_SIDED|95.0|-0.35|5.02|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||5.02|-0.35|0.0440
71804410|NCT03029208|143108265|SUPERIORITY||LS mean difference|-2.61||||0.9523|TWO_SIDED|95.0|-5.68|0.46|||MMRM||SF-36 HRQoL bodily pain domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||0.46|-5.68|0.9523
71804411|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.05||||0.4811|TWO_SIDED|95.0|-1.82|1.91|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.91|-1.82|0.4811
71804412|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.28||||0.3834|TWO_SIDED|95.0|-1.56|2.11|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.11|-1.56|0.3834
71804413|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.26||||0.3983|TWO_SIDED|95.0|-1.72|2.24|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.24|-1.72|0.3983
71804414|NCT03029208|143108265|SUPERIORITY||LS mean difference|-0.18||||0.5617|TWO_SIDED|95.0|-2.51|2.15|||MMRM||SF-36 HRQoL general health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.15|-2.51|0.5617
71804415|NCT03029208|143108265|SUPERIORITY||LS mean difference|-1.15||||0.8336|TWO_SIDED|95.0|-3.48|1.18|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.18|-3.48|0.8336
71841613|NCT05012163|143193228|SUPERIORITY|||||||0.506||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket and patients sent messages offering $1 cash in exchange for vaccination; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent messages offering $1 cash.||||.506
71804416|NCT03029208|143108265|SUPERIORITY||LS mean difference|-1.41||||0.9188|TWO_SIDED|95.0|-3.4|0.57|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||0.57|-3.40|0.9188
71804417|NCT03029208|143108265|SUPERIORITY||LS mean difference|-0.48||||0.6495|TWO_SIDED|95.0|-2.96|1.99|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.99|-2.96|0.6495
71804418|NCT03029208|143108265|SUPERIORITY||LS mean difference|-0.27||||0.5737|TWO_SIDED|95.0|-3.09|2.56|||MMRM||SF-36 HRQoL mental health domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||2.56|-3.09|0.5737
71804419|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.33||||0.3963|TWO_SIDED|95.0|-2.15|2.82|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||2.82|-2.15|0.3963
71804420|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.62||||0.322|TWO_SIDED|95.0|-2.01|3.25|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||3.25|-2.01|0.3220
71804421|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.53||||0.3485|TWO_SIDED|95.0|-2.13|3.18|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||3.18|-2.13|0.3485
71804422|NCT03029208|143108265|SUPERIORITY||LS mean difference|-1.49||||0.8064|TWO_SIDED|95.0|-4.87|1.9|||MMRM||SF-36 HRQoL role-emotional domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.90|-4.87|0.8064
71804423|NCT03029208|143108265|SUPERIORITY||LS mean difference|-1.29||||0.8687|TWO_SIDED|95.0|-3.57|0.98|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||0.98|-3.57|0.8687
71804424|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.71||||0.2435|TWO_SIDED|95.0|-1.29|2.7|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||2.70|-1.29|0.2435
71804425|NCT03029208|143108265|SUPERIORITY||LS mean difference|-0.87||||0.7747|TWO_SIDED|95.0|-3.15|1.41|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.41|-3.15|0.7747
71804426|NCT03029208|143108265|SUPERIORITY||LS mean difference|-0.73||||0.7141|TWO_SIDED|95.0|-3.26|1.81|||MMRM||SF-36 HRQoL role-physical domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.81|-3.26|0.7141
71804427|NCT03029208|143108265|SUPERIORITY||LS mean difference|-1.03||||0.7803|TWO_SIDED|95.0|-3.65|1.59|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 8.|||1.59|-3.65|0.7803
71804428|NCT03029208|143108265|SUPERIORITY||LS mean difference|-1.18||||0.8556|TWO_SIDED|95.0|-3.35|1.0|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 12.|||1.00|-3.35|0.8556
71804429|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.08||||0.4763|TWO_SIDED|95.0|-2.61|2.77|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.77|-2.61|0.4763
71804430|NCT03029208|143108265|SUPERIORITY||LS mean difference|0.73||||0.3208|TWO_SIDED|95.0|-2.35|3.8|||MMRM||SF-36 HRQoL social functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||3.80|-2.35|0.3208
71804431|NCT03029208|143108266|SUPERIORITY||LS mean difference|-1.02||||0.791|TWO_SIDED|95.0|-3.5|1.46|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||1.46|-3.50|0.7910
71804432|NCT03029208|143108266|SUPERIORITY||LS mean difference|-1.45||||0.8648|TWO_SIDED|95.0|-4.03|1.14|||MMRM||SF-36 HRQoL vitality domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.14|-4.03|0.8648
71804433|NCT03029208|143108267|SUPERIORITY||LS mean difference|-0.28||||0.5879|TWO_SIDED|95.0|-2.75|2.19|||MMRM||SF-36 HRQoL physical functioning domain score was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 28.|||2.19|-2.75|0.5879
71804434|NCT03029208|143108267|SUPERIORITY||LS mean difference|-1.43||||0.8525|TWO_SIDED|95.0|-4.12|1.26|||MMRM||SF-36 HRQoL physical functioning domain scor was analyzed using an MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms at Week 52.|||1.26|-4.12|0.8525
71804435|NCT03029208|143108268|SUPERIORITY||LS mean difference|0.03||||0.3154|TWO_SIDED|95.0|-0.09|0.14|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.14|-0.09|0.3154
71804436|NCT03029208|143108269|SUPERIORITY||LS mean difference|-3.4||||0.7651|TWO_SIDED|95.0|-12.7|5.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||5.9|-12.7|0.7651
71804437|NCT03029208|143108270|SUPERIORITY||LS mean difference|-6.43||||0.9875|TWO_SIDED|95.0|-12.05|-0.82|||MMRM||Tired/Low energy/Weak domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-0.82|-12.05|0.9875
71804438|NCT03029208|143108270|SUPERIORITY||LS mean difference|-4.11||||0.9663|TWO_SIDED|95.0|-8.52|0.3|||MMRM||Chest pain/Shortness of breath domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.30|-8.52|0.9663
71804439|NCT03029208|143108270|SUPERIORITY||LS mean difference|-6.6||||0.993|TWO_SIDED|95.0|-11.84|-1.35|||MMRM||Cognitive domain: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||-1.35|-11.84|0.9930
71804440|NCT03029208|143108270|SUPERIORITY||LS mean difference|-3.03||||0.8765|TWO_SIDED|95.0|-8.19|2.12|||MMRM||Shortness of breath, no activity: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.12|-8.19|0.8765
71804441|NCT03029208|143108270|SUPERIORITY||LS mean difference|-4.27||||0.9464|TWO_SIDED|95.0|-9.48|0.94|||MMRM||Severity-short breath, Resting: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.94|-9.48|0.9464
71804442|NCT03029208|143108270|SUPERIORITY||LS mean difference|-5.31||||0.9101|TWO_SIDED|95.0|-13.09|2.47|||MMRM||Difficulty standing for long time: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||2.47|-13.09|0.9101
71675353|NCT01908829|142868086|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.27|2.13||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.13|1.27|<0.001
71675354|NCT01908829|142868086|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.001|TWO_SIDED|95.0|1.17|1.91||p\<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.91|1.17|=0.001
71804443|NCT03029208|143108270|SUPERIORITY||LS mean difference|-6.52||||0.9586|TWO_SIDED|95.0|-13.9|0.86|||MMRM||Difficulty sleeping: MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.86|-13.90|0.9586
71804444|NCT03029208|143108271|SUPERIORITY||LS mean difference|0.27||||0.981|TWO_SIDED|95.0|0.02|0.53|||MMRM||MMRM model was fitted from Baseline up to Week 8 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.53|0.02|0.9810
71804445|NCT03029208|143108271|SUPERIORITY||LS mean difference|0.05||||0.6743|TWO_SIDED|95.0|-0.17|0.26|||MMRM||MMRM model was fitted from Baseline up to Week 12 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.26|-0.17|0.6743
71804446|NCT03029208|143108271|SUPERIORITY||LS mean difference|0.16||||0.8997|TWO_SIDED|95.0|-0.09|0.4|||MMRM||MMRM model was fitted from Baseline up to Week 28 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.40|-0.09|0.8997
71804447|NCT03029208|143108271|SUPERIORITY||LS mean difference|0.18||||0.8835|TWO_SIDED|95.0|-0.12|0.47|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, dialysis type, dialysis start manner, Baseline value and Baseline value by time and treatment by time interactions.|||0.47|-0.12|0.8835
71804448|NCT01046643|143108315|SUPERIORITY_OR_OTHER|||||||0.222||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.222
71804449|NCT01046643|143108315|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.107
71804450|NCT01046643|143108315|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.127
71804451|NCT01046643|143108315|SUPERIORITY_OR_OTHER|||||||0.954||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.954
71804452|NCT01046643|143108315|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.385
71804453|NCT01046643|143108315|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.310
71804454|NCT01046643|143108316|SUPERIORITY_OR_OTHER|||||||0.594||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.594
71841614|NCT05012163|143193228|SUPERIORITY|||||||0.378||||||Comments: Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those sent active control messages.||||0.378
71675355|NCT01908829|142868087|SUPERIORITY||Odds Ratio (OR)|1.42|||=|0.003|TWO_SIDED|95.0|1.13|1.79||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.13|=0.003
71804455|NCT01046643|143108316|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.653
71804456|NCT01046643|143108317|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.452
71804457|NCT01046643|143108317|SUPERIORITY_OR_OTHER|||||||0.868||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.868
71804458|NCT01046643|143108317|SUPERIORITY_OR_OTHER|||||||0.549||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.549
71804459|NCT01046643|143108317|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = \<0.05"||||.124
71804460|NCT01046643|143108317|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = \<0.05"||||.158
71804461|NCT01046643|143108317|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = \<0.05"||||.055
71804462|NCT01046643|143108318|SUPERIORITY_OR_OTHER|||||||0.561||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.561
71804463|NCT01046643|143108318|SUPERIORITY_OR_OTHER|||||||0.726||95.0|||||t-test, 2 sided|||p-value for null hypothesis = \<0.05||||.726
71804464|NCT00289341|143108319|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||for injection site reaction only||||0.001
71804465|NCT00289341|143108319|SUPERIORITY_OR_OTHER||||||>|0.2||95.0|||||Fisher Exact|||for all other adverse events||||>0.2
71804466|NCT00289341|143108321|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Linear Spline model|||||||0.016
71804467|NCT00754845|143108340|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.91|||Log Rank|Stratified by the stratification factors at randomization||||0.91|0.48|0.01
71804468|NCT00754845|143108341|SUPERIORITY|||||||0.007|||||||Log Rank|||||||0.007
71804469|NCT00754845|143108342|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.83|TWO_SIDED|95.0|0.73|1.28|||Log Rank|||||1.28|0.73|0.83
71841615|NCT05012163|143193228|SUPERIORITY||||||<|0.001||||||Pairwise comparisons between patients offered scratch-off tickets for vaccination and those in other arms (Analyses 1, 2 and 3) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering a scratch-off lottery ticket in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering scratch-off tickets compared to those who were not sent messages.||||<.001
71894282|NCT00955110|143310648|SUPERIORITY_OR_OTHER||Least Square Mean Difference|56.0|||<|0.001|TWO_SIDED|95.0|43.1|68.9||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||68.9|43.1|<0.001
71804470|NCT00754845|143108343|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||||||<0.01
71804471|NCT02120924|143108376|EQUIVALENCE|Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|Mean Difference (Net)|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Bioequivalence was established if the 90% CI for the ratio of Test/Reference means was contained within the interval \[0.80, 1.25\].|The primary endpoint was the percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population.||1.05|0.92|
71804472|NCT02120924|143108377|EQUIVALENCE|A two-sided, continuity-corrected, 90% CI on the Test-to-Reference difference for the proportion of subjects with treatment success on the IGE was constructed.|Mean Difference (Net)|0.044|||||TWO_SIDED|90.0|-0.028|0.116|||||Bioequivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\].|||0.116|-0.028|
71804473|NCT01884350|143108378|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.24||||0.8117|TWO_SIDED|95.0|-2.18|1.7||P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24|t-test, 2 sided|||||1.7|-2.18|0.8117
71804474|NCT01884350|143108379|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
71804475|NCT01884350|143108379|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks||||<0.0001
71804476|NCT01884350|143108380|NON_INFERIORITY_OR_EQUIVALENCE|F-test p-value is obtained from the one-way ANOVA model||||||0.8707|||||||ANOVA|||||||0.8707
71894283|NCT00955110|143310648|SUPERIORITY_OR_OTHER||Least Square Mean Difference|66.8|||<|0.001|TWO_SIDED|95.0|53.9|79.7||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA|||||79.7|53.9|<0.001
71675356|NCT01908829|142868087|SUPERIORITY||Odds Ratio (OR)|1.44|||=|0.004|TWO_SIDED|95.0|1.12|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.12|=0.004
71804477|NCT01884350|143108380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.6399|TWO_SIDED|95.0|-2.88|4.68||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.68|-2.88|0.6399
71804478|NCT01884350|143108380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.9616|TWO_SIDED|95.0|-3.45|3.29||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||3.29|-3.45|0.9616
71804479|NCT01884350|143108380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.6341|TWO_SIDED|95.0|-2.6|4.24||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided|||||4.24|-2.60|0.6341
71804480|NCT01884350|143108381|SUPERIORITY|||||||0.1924||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1924
71804481|NCT01884350|143108381|SUPERIORITY|||||||0.0305||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0305
71804482|NCT01884350|143108381|SUPERIORITY|||||||0.0107||||||Mini-mental state examination score|Wald Chi-square test|||||||0.0107
71804483|NCT01884350|143108381|SUPERIORITY|||||||0.6982||||||Higher managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.6982
71804484|NCT01884350|143108381|SUPERIORITY|||||||0.7277||||||Higher professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7277
71804485|NCT01884350|143108381|SUPERIORITY|||||||0.7581||||||Intermediate occupations vs UKSOC1|Wald Chi-square test|||||||0.7581
71804486|NCT01884350|143108381|SUPERIORITY|||||||0.2328||||||Large employers and higher managerial and adm. occupations vs UKSOC1|Wald Chi-square test|||||||0.2328
71804487|NCT01884350|143108381|SUPERIORITY|||||||0.7507||||||Lower managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test|||||||0.7507
71804488|NCT01884350|143108381|SUPERIORITY|||||||0.0091||||||Lower supervisory and technical occupations vs UKSOC1|Wald Chi-square test|||||||0.0091
71804489|NCT01884350|143108381|SUPERIORITY|||||||0.673||||||Never worked and long-term unemployed vs UKSOC1|Wald Chi-square test|||||||0.6730
71804490|NCT01884350|143108381|SUPERIORITY|||||||0.0117||||||Routine occupations vs UKSOC1|Wald Chi-square test|||||||0.0117
71804491|NCT01884350|143108381|SUPERIORITY|||||||0.191||||||Semi-routine occupations vs UKSOC1|Wald Chi-square test|||||||0.1910
71804492|NCT01884350|143108381|SUPERIORITY|||||||0.9559||||||Paroxysmal vs Persistent Atrial Fibrillation|Wald Chi-square test|||||||0.9559
71804493|NCT01884350|143108381|SUPERIORITY|||||||0.0264||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.0264
71804494|NCT01884350|143108381|SUPERIORITY|||||||0.1087||||||\<=2 Drink/Day Average vs None|Wald Chi-square test|||||||0.1087
71804495|NCT01884350|143108381|SUPERIORITY|||||||0.0679||||||\>=3 Drink/Day Average vs None|Wald Chi-square test|||||||0.0679
71804496|NCT01884350|143108381|SUPERIORITY|||||||0.2128||||||Paroxysmal vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.2128
71804497|NCT01884350|143108381|SUPERIORITY|||||||0.3739||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test|||||||0.3739
71804498|NCT01884350|143108381|SUPERIORITY|||||||0.843||||||VKA status: Naive vs. Non-Naive|Wald Chi-square test|||||||0.843
71804499|NCT01968434|143108446|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||The sample size was calculated to detect a 0.75 point difference between any two treatment groups with a 90% power and p\<0.05. Such sample size was 60 subject which was elevated ot 75 subjects per group to account for drop outs. For comparison of cough evaluation before and after treatment a paired Student t test was used.||||<0.01
71804500|NCT01968434|143108447|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71804501|NCT01968434|143108448|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71804502|NCT02091167|143108449|OTHER|||||||0.05|||||||ANOVA|||We powered for a medium effect size based on our previous study with effect size (partial ղ2) of 0.10384 for the main within-subject factor in the two-way ANOVA with repeated measures. With a power of 80%, and a two-sided probability of a type I error of 5%, the resulting minimum sample size was 30 participants. To account for waiving or dropouts we increased the estimated sample size to approximately 10%, resulting in 33 subjects in total (approximately 16 to 17 subjects in each group).|"Most of data (age, patterns of crack-cocaine use, 5-items OCCS) were normally distributed according to the D'Agostino \& Pearson normality test, thus they were analyzed by parametric tests. Between-group (sham- and real tDCS) comparisons were conducted by unpaired Student´s t-tests. For all other non-parametric data (gender, schooling, employment, marital state and tobacco use), Chi-square or Fisher tests were used to compare sham and real tDCS groups.~Besides the two-way ANOVA with repeated measures followed by Bonferroni-corrected t-tests, linear regression analyses were done over craving scores obtained along the 4-week treatment (five time-points measurements) for both groups. Additional comparisons between initial and final OCDS scores were done by paired t-tests for each group, and differences between final and initial scores were compared between sham-tDCS and real tDCS groups with unpaired t-test."|||0.05
71804503|NCT02091167|143108450|OTHER|||||||0.05|||||||Fisher Exact|||Two patients from each group were lost to follow-up after their discharge from the hospital.||||0.05
71804504|NCT02669329|143108459|OTHER||success proportion|85.2|||||TWO_SIDED|95.0|72.9|93.4||||||||93.4|72.9|
71804505|NCT01543256|143108461|NON_INFERIORITY|Non-Inferiority margin was 20%||||||0.008|||||||Exact non-inferiority|||||||.008
71804506|NCT01543256|143108462|SUPERIORITY|||||||0.568|||||||Fisher Exact|||||||.568
71804507|NCT01543256|143108463|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
71804508|NCT01543256|143108464|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||.99
71804509|NCT01543256|143108465|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||.519
71804510|NCT01543256|143108466|SUPERIORITY||||||<|0.001|||||||Negative binomial|||||||<.001
71804511|NCT02055352|143108508|NON_INFERIORITY_OR_EQUIVALENCE|A change of 5-10% from baseline values is considered to be clinically important. The estimated adjusted treatment difference for budesonide 400 μg twice a day/ indacaterol 150 μg once daily minus fixed combination of fluticasone/ salmeterol 250/ 50 μg twice daily was displayed along with the associated one-sided 97.5% confidence interval. If the lower limit of this confidence interval was to the right (i.e. above) - 10 mL, then non-inferiority could be claimed.||||||0.004|||||||Mixed effects General linear model|||||||0.004
71841616|NCT05012163|143193228|SUPERIORITY||||||<|0.001|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent active control messages and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent active control messages compared to those who were not sent messages.||||<.001
71804512|NCT02062502|143108517|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-3.2|3.2|||Miettinen and Nurminen|||||3.2|-3.2|<0.001
71804513|NCT02062502|143108518|NON_INFERIORITY_OR_EQUIVALENCE|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.|Risk Difference (RD)|0.95|||<|0.001|TWO_SIDED|95.0|0.85|1.06|||t-test, 2 sided|||||1.06|0.85|<0.001
71804514|NCT02062502|143108518|SUPERIORITY_OR_OTHER||Antibody Response Rate|97.2|||<|0.001|TWO_SIDED|95.0|94.4|98.9|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||98.9|94.4|<0.001
71804515|NCT03809182|143108524|SUPERIORITY|||||||0.38|TWO_SIDED|95.0||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in plasmatic glucose levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.38
71804516|NCT03809182|143108525|SUPERIORITY|||||||0.02||||||A p-value less than .05 was considered statistically significant.|Mixed Models Analysis|||Null hypothesis: There is no difference in insulin levels between dexmedetomidine and 0.9% sodium-chloride groups.||||0.02
71804517|NCT02165722|143108599|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
71804518|NCT02165722|143108599|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.||||||<0.001
71804519|NCT02165722|143108599|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.||||<0.001
71804520|NCT02165722|143108599|OTHER|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||<0.001
71804521|NCT02165722|143108600|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.||||||0.001
71804522|NCT02165722|143108600|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
71804523|NCT02165722|143108600|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
71804524|NCT02165722|143108600|OTHER|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||||||>0.05
71804525|NCT01055639|143108609|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
71804526|NCT01055639|143108610|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71804527|NCT01055639|143108611|SUPERIORITY_OR_OTHER|||||||0.88|||||||t-test, 2 sided|||||||0.88
71804528|NCT01055639|143108612|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
71804529|NCT01055639|143108613|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||||||0.87
71804530|NCT01055639|143108614|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
71804531|NCT01055639|143108615|SUPERIORITY_OR_OTHER|||||||0.19|||||||t-test, 2 sided|||||||0.19
71804532|NCT01055639|143108616|SUPERIORITY_OR_OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
71804533|NCT01055639|143108617|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.00
71804534|NCT01614210|143108623|OTHER||percentage decrease in Ki67 after 7 days|||||0.0001|||||||t-test, 1 sided|||||||0.0001
71804535|NCT02265705|143108667|SUPERIORITY||Odds Ratio (OR)|4.1||||0.001|TWO_SIDED|95.0|2.5|6.9|||Regression, Logistic|||||6.9|2.5|0.001
71804536|NCT02265705|143108668|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.056||0.001|TWO_SIDED|95.0|-0.31|-0.09|||ANCOVA|||||-0.09|-0.31|0.001
71804537|NCT02265705|143108669|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.116||0.001|TWO_SIDED|95.0|-1.25|-0.79|||ANCOVA|||||-0.79|-1.25|0.001
71804538|NCT02265705|143108670|SUPERIORITY||Difference in response rate|1.4|||||TWO_SIDED|95.0|-0.5|3.3||||||||3.3|-0.5|
71804539|NCT02265705|143108671|SUPERIORITY||Median Difference (Final Values)|-12.9||||0.004|TWO_SIDED|95.0|-28.0|-2.9|||Wilcoxon (Mann-Whitney)|||||-2.9|-28.0|0.004
71804540|NCT02265705|143108672|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.2|-0.3|||ANCOVA|||||-0.3|-1.2|0.002
71804541|NCT02265705|143108673|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|0.001
71804542|NCT02265705|143108674|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|||||-0.5|-1.3|0.001
71675357|NCT01908829|142868087|SUPERIORITY||Odds Ratio (OR)|1.5|||=|0.003|TWO_SIDED|95.0|1.15|1.96||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.96|1.15|=0.003
71675358|NCT01908829|142868087|SUPERIORITY||Odds Ratio (OR)|1.43|||=|0.006|TWO_SIDED|95.0|1.11|1.84||p\<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.84|1.11|=0.006
71675359|NCT01908829|142868088|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.065|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.66|0.99|=0.065
71675360|NCT01908829|142868088|SUPERIORITY||Odds Ratio (OR)|1.41|||=|0.004|TWO_SIDED|95.0|1.11|1.79|||Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.79|1.11|=0.004
71675361|NCT01908829|142868088|SUPERIORITY||Odds Ratio (OR)|1.64|||<|0.001|TWO_SIDED|95.0|1.3|2.07|||Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||2.07|1.30|<0.001
71675362|NCT01908829|142868088|SUPERIORITY||Odds Ratio (OR)|1.55|||<|0.001|TWO_SIDED|95.0|1.24|1.94|||Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.||1.94|1.24|<0.001
71675363|NCT01339923|142868124|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|-1.0|||||TWO_SIDED|95.0|-6.4|3.9|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.||3.9|-6.4|
71675364|NCT01339923|142868124|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority.|Vaccine group difference|0.0|||||TWO_SIDED|95.0|-5.2|7.6|||Miettinen and Nurminen method|||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.||7.6|-5.2|
71675365|NCT01430403|142868147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|STANDARD_ERROR_OF_MEAN|0.331||0.03|TWO_SIDED|95.0|0.25|0.92|||Odds Ratio|Adjusted for Site, dosing group and treatment step|Placebo serves as the reference group. Values \< 1 represent more exacerbations in the placebo arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||0.92|0.25|0.03
71675366|NCT01430403|142868148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.41||0.45|TWO_SIDED|95.0|0.33|1.64|||Odds Ratio|Adjusted for Site, dosing group and treatment step|ICS Boost serves as the reference group. Values \< 1 represent more exacerbations in the ICS arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.||1.64|0.33|0.45
71675367|NCT01430403|142868149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53|||<|0.01|TWO_SIDED|95.0|2.38|5.22|||Chi-squared||Adjusted for site|||5.22|2.38|<0.01
71675368|NCT01430403|142868150|SUPERIORITY_OR_OTHER||Linear Regression|0.004||||0.94|TWO_SIDED|95.0|-0.1|0.11|||F-Test|||||0.11|-0.10|0.94
71675369|NCT01430403|142868150|SUPERIORITY_OR_OTHER||Linear Regression|-0.13||||0.33|TWO_SIDED|95.0|-0.4|0.13|||F-Test|||||0.13|-0.40|0.33
71675370|NCT01430403|142868151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.552|TWO_SIDED|95.0|0.87|1.31|||Chi-squared|||||1.31|0.87|0.552
71675371|NCT01430403|142868151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.37|TWO_SIDED|95.0|0.87|1.44|||Chi-squared|||||1.44|0.87|0.37
71675372|NCT01430403|142868152|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.3||0.09|TWO_SIDED|95.0|-1.11|0.07|||Regression, Linear|Adjustments for randomization CASI, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.07|-1.11|0.09
71675373|NCT01430403|142868153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.86|0.34|||Regression, Linear|Adjustments for randomization CASI, site and dosing group||||0.34|-0.86|0.39
71675374|NCT01430403|142868154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|1.58||0.84|TWO_SIDED|95.0|-3.42|2.78|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.78|-3.42|0.84
71675375|NCT01430403|142868155|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|1.59||0.14|TWO_SIDED|95.0|-0.76|5.51|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site and dosing group.||||5.51|-0.76|0.14
71675376|NCT01430403|142868156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.49|1.99|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.99|-1.49|0.78
71675377|NCT01430403|142868157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|0.89||0.2|TWO_SIDED|95.0|-0.61|2.91|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site and dosing group.||||2.91|-0.61|0.20
71675378|NCT01430403|142868158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.4||0.006|TWO_SIDED|95.0|0.32|1.9|||Regression, Linear|Adjustments for randomization ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.90|0.32|0.006
71675379|NCT01430403|142868159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.41||0.89|TWO_SIDED|95.0|-0.76|0.86|||Regression, Linear|Adjustments for randomization ACT, site and dosing group.||||0.86|-0.76|0.89
71841617|NCT05012163|143193228|SUPERIORITY|Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.||||||0.121|||||||Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent active control messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those sent active control messages.||||.121
71841618|NCT05012163|143193228|SUPERIORITY|||||||0.002||||||Pairwise comparisons between patients offered cash for vaccination and those in active or passive control (Analyses 5 and 6) were analyzed in the same regression.|Regression, Linear|||Null hypothesis: There is no difference in vaccination rates between patients sent messages offering $1 cash in exchange for vaccination and those sent no study messages; Alternative hypothesis: the vaccination rate is higher in patients sent messages offering $1 cash compared to those who were not sent messages.||||.002
71841619|NCT04070573|143193245|SUPERIORITY||Risk Difference (RD)|0.035||||0.28|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.28
71675380|NCT01430403|142868160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.36||0.05|TWO_SIDED|95.0|0.0|1.41|||Regression, Linear|Adjustments for randomization C-ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.41|0.00|0.05
71675381|NCT01430403|142868161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.37||0.12|TWO_SIDED|95.0|-0.15|1.3|||Regression, Linear|Adjustments for randomization C-ACT, site and dosing group||||1.30|-0.15|0.12
71675382|NCT01430403|142868162|SUPERIORITY_OR_OTHER||Rate Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.68||0.63|TWO_SIDED|95.0|0.19|0.72|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||0.72|0.19|0.63
71841620|NCT04070573|143193246|SUPERIORITY||Risk Difference (RD)|0.035||||0.31|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.31
71841621|NCT04070573|143193247|SUPERIORITY||Risk Difference (RD)|0.019||||0.61|TWO_SIDED||||||Chi-squared||Risk difference direction = 81mg arm minus 162mg arm.|||||0.61
71841622|NCT04070573|143193250|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.72|TWO_SIDED||||||t-test, 2 sided|||||||0.72
71841623|NCT02567409|143193264|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.69|1.98|||||Hazard ratio relative to arm B.|||1.98|0.69|
71841624|NCT02567409|143193265|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.71|2.48|||||Hazard ratio relative to arm B.|||2.48|0.71|
71841625|NCT02567409|143193266|SUPERIORITY|||||||0.51|||||||Fisher Exact|||||||0.51
71841626|NCT05237284|143193325|SUPERIORITY|||||||0.6999|||||||Wilcoxon (Mann-Whitney)|||CAFS at Week 24 was analyzed using the Wilcoxon-Mann-Whitney test to compare mean scores between the treatment groups at Week 24.||||0.6999
71841627|NCT05237284|143193328|SUPERIORITY||LS Mean Difference|0.52||||0.2182|TWO_SIDED|95.0|-0.31|1.35|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline NfL, disease duration-by-visit interaction, and baseline ALSFRS-R score-by-visit interaction.||1.350|-0.310|0.2182
71675383|NCT01430403|142868163|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.63||0.99|TWO_SIDED|95.0|0.29|3.46|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||3.46|0.29|0.99
71841628|NCT05237284|143193329|SUPERIORITY||LS Mean Difference|0.419||||0.8134|TWO_SIDED|95.0|-3.075|3.914|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline SVC, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction, and baseline SVC-by-visit interaction.||3.914|-3.075|0.8134
71841629|NCT05237284|143193330|SUPERIORITY||Ratio of the LS Geometric Mean Ratios|0.961||||0.2356|TWO_SIDED|95.0|0.899|1.027|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, log transformed baseline NfL, disease duration-by-visit interaction, and log transformed baseline NfL-by-visit interaction.||1.027|0.899|0.2356
71841630|NCT05237284|143193331|SUPERIORITY||LS Mean difference|-0.005||||0.9565|TWO_SIDED|95.0|-0.193|0.183|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline megascore, baseline NfL, disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline megascore-by-visit interaction.||0.183|-0.193|0.9565
71841631|NCT05237284|143193336|SUPERIORITY||Least Square (LS) Mean Difference|-0.414||||0.5289|TWO_SIDED|95.0|-1.706|0.878|||MMRM|||Analysis was performed using MMRM including treatment group, visit, randomization strata of the geographic region, ALS onset region, use of riluzole, use of edaravone, use of the combination of sodium phenylbutyrate and taurursodiol, treatment-by-visit interaction, disease duration, baseline ALSFRS-R score, baseline serum neurofilament light chain (NfL), disease duration-by-visit interaction, baseline NfL-by-visit interaction and baseline ALSFRS-R score-by-visit interaction.||0.878|-1.706|0.5289
71675384|NCT01430403|142868164|SUPERIORITY_OR_OTHER||Ratio|0.72|STANDARD_ERROR_OF_MEAN|0.32||0.31|TWO_SIDED|95.0|0.39|1.35|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||1.35|0.39|0.31
71675385|NCT01430403|142868165|SUPERIORITY_OR_OTHER||Ratio|0.48|STANDARD_ERROR_OF_MEAN|0.39||0.06|TWO_SIDED|95.0|0.23|1.02|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group||||1.02|0.23|0.06
71675386|NCT01430403|142868166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|1.48||0.9|TWO_SIDED|95.0|-3.08|2.72|||Regression, Linear|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)||||2.72|-3.08|0.90
71841632|NCT05237284|143193337|SUPERIORITY|||||||0.183|||||||ANCOVA|||Analysis was performed using rank analysis of covariance (ANCOVA) model including treatment group, randomization strata of the geographic region of the study site, ALS onset region (bulbar or other areas), use of riluzole (yes or no), use of edaravone (yes or no), use of the combination of sodium phenylbutyrate and taurursodiol (yes or no), disease duration (from first symptom onset to the screening visit), baseline ALSFRS-R score and baseline NfL.||||0.1830
71841633|NCT03213873|143193366|SUPERIORITY||Interaction effect time x group|0.4||||0.57|TWO_SIDED|95.0|-1.0|1.9|||Mixed Models Analysis|||||1.9|-1.0|0.57
71841634|NCT03213873|143193367|SUPERIORITY||Interaction effect time x group|0.05||||0.25|TWO_SIDED|95.0|-0.03|0.12|||Mixed Models Analysis|||||0.12|-0.03|0.25
71841635|NCT03213873|143193368|SUPERIORITY||Interaction effect time x group|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
71841636|NCT02361216|143193379|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.29|||<|0.001|TWO_SIDED|95.0|2.82|14.0|||Cochran-Mantel-Haenszel|||AKclear100 at Week 8: full analysis set. The null hypothesis was that there is no difference at Week 8 in AKclear100 rates between ingenol mebutate gel 0.027% and vehicle gel. This hypothesis was tested against the 2-sided alternative of a difference between the 2 treatment groups.||14|2.82|<0.001
71841637|NCT02361216|143193380|SUPERIORITY||Ratio of clearance rates|6.81|||<|0.001|TWO_SIDED|95.0|4.16|11.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate (0.027% relative to vehicle), adjusted for pooled sites|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||11.1|4.16|<0.001
71841638|NCT02361216|143193381|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance rates|6.53|||<|0.001|TWO_SIDED|95.0|4.04|10.5|||Mantel Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The pre-specified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.5|4.04|<0.001
71841639|NCT02361216|143193382|SUPERIORITY_OR_OTHER_LEGACY||Ratio of clearance|0.28|||<|0.001|TWO_SIDED|95.0|0.24|0.32||Negative binominal regression with log baseline count as offset variable and treatment group, anatomical location stratum and pooled site as factors.|Cochran-Mantel-Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.32|0.24|<0.001
71841640|NCT01866163|143193390|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|30.27|||<|0.001|TWO_SIDED|95.0|9.72|94.3|||Mantel Haenszel|||Multiple imputations were used to handle missing data.||94.30|9.72|<0.001
71841641|NCT01866163|143193391|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.28|||<|0.001|TWO_SIDED|95.0|-3.9|-2.67|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-2.67|-3.90|<0.001
71841642|NCT01866163|143193392|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.76|-0.78|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.||-0.78|-1.76|<0.001
71841643|NCT02575950|143193448|SUPERIORITY||Mean Difference (Final Values)|-9.34|||<|0.001|TWO_SIDED|95.0|-14.71|-3.96|||ANCOVA|||Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.||-3.96|-14.71|<.001
71841644|NCT01960452|143193544|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2791|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2791
71841645|NCT01960452|143193544|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.9|||||||t-test, 2 sided|||||||0.9
71675387|NCT01430403|142868167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.52||0.86|TWO_SIDED|95.0|-3.26|2.71|||Regression, Linear|Adjustments for site and dosing group.||||2.71|-3.26|0.86
71841646|NCT01960452|143193545|OTHER|Group comparison, for both absolute (spatially z-score normalized across all electrodes for each subject)||||||0.1069|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.1069
71841647|NCT01960452|143193545|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.546|||||||t-test, 2 sided|||||||0.546
71841648|NCT01960452|143193546|OTHER|Group comparison, for absolute (spatially z-score normalized across all electrodes for each subject)||||||0.2918|||||||t-test, 2 sided|||Only reporting values for approximate 10-20 channel CP1||||0.2918
71841649|NCT01960452|143193546|OTHER|Group comparison, for absolute multiple comparisons correction across electrodes using threshold free cluster enhancement (TFCE)||||||0.761|||||||t-test, 2 sided|||||||0.761
71675388|NCT03660189|142868169|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71675389|NCT03660189|142868169|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71894284|NCT01416181|143310651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.2866|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 2 years||1.13|0.66|0.2866
71894285|NCT01416181|143310651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.753|TWO_SIDED|95.0|0.74|1.53|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS||1.53|0.74|0.7530
71894286|NCT01416181|143310651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9137|TWO_SIDED|95.0|0.74|1.3|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW||1.30|0.74|0.9137
71675390|NCT03660189|142868171|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71894287|NCT01416181|143310651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0012|TWO_SIDED|95.0|0.4|0.8|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (either hand)||0.80|0.40|0.0012
71675391|NCT03660189|142868174|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
71675392|NCT03660189|142868175|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
71675393|NCT03660189|142868179|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71675394|NCT03660189|142868180|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71675395|NCT02099110|142868188|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.46|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
71804543|NCT00779246|143108675|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||>|0.05|TWO_SIDED|95.0|0.5|2.9|||Regression, Logistic|||Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.||2.9|0.5|>0.05
71804544|NCT00383435|143108681|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71804545|NCT00383435|143108681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||ANCOVA|||||||0.007
71804546|NCT00383435|143108682|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71804547|NCT00383435|143108682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029|||||||ANCOVA|||||||0.029
71804548|NCT00383435|143108683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||||||0.002
71804549|NCT00383435|143108683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059|||||||ANCOVA|||||||0.059
71804550|NCT00553267|143108794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.52|<|0.0001||95.0|-3.77|-1.75||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.75|-3.77|<0.0001
71804551|NCT00553267|143108794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001||95.0|-3.86|-1.84||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."||-1.84|-3.86|<0.0001
71804552|NCT00553267|143108795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.15|-2.16|||ANCOVA|Adjusted for baseline and country effect||||-2.16|-5.15|<0.0001
71804553|NCT00553267|143108795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|-5.35|-2.36|||ANCOVA|Adjusted for baseline and country effect||||-2.36|-5.35|<0.0001
71804554|NCT00553267|143108796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002|TWO_SIDED|95.0|1.21|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.21|0.002
71804555|NCT00553267|143108796|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91|||<|0.001||95.0|1.37|2.65|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.65|1.37|<0.001
71804556|NCT00553267|143108797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004||95.0|1.3|4.25|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.25|1.30|0.004
71804557|NCT00553267|143108797|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.004||95.0|1.29|4.22|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||4.22|1.29|0.004
71804558|NCT00553267|143108798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.002||95.0|1.21|2.34|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.34|1.21|0.002
71804559|NCT00553267|143108798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||<|0.001||95.0|1.38|2.68|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.68|1.38|<0.001
71804560|NCT00553267|143108799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.027||95.0|1.04|2.0|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.00|1.04|0.027
71804561|NCT00553267|143108799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.008||95.0|1.12|2.15|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.15|1.12|0.008
71804562|NCT00553267|143108800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.006||95.0|1.14|2.21|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.21|1.14|0.006
71804563|NCT00553267|143108800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.002||95.0|1.2|2.32|||Mantel Haenszel|Mantel-Haenszel statistics adjusted for country effect||||2.32|1.20|0.002
71804564|NCT00553267|143108801|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||0.006
71804565|NCT00553267|143108801|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test||||||<0.001
71894288|NCT01416181|143310651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.1251|TWO_SIDED|95.0|0.48|1.09|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (dominant hand)||1.09|0.48|0.1251
71841650|NCT05218096|143193553|OTHER|Difference|Difference|-7.1||||0.6797|TWO_SIDED|90.0|-28.8|15.0|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||15.0|-28.8|0.6797
71841651|NCT05218096|143193553|OTHER|Difference|Difference|-7.1||||0.7341|TWO_SIDED|90.0|-34.8|19.3|||Barnard's Unconditional Exact Test||CI calculated using the Chan and Zhang method.|||19.3|-34.8|0.7341
71841652|NCT03655028|143193611|SUPERIORITY|||||||0.85||||||The co-variate used in the analysis was the 6 minute walk distance at baseline.|ANCOVA|||||||0.85
71841653|NCT03655028|143193612|SUPERIORITY|||||||0.307||||||The co-variant used to adjust the ANCOVA was the baseline step count/day.|ANCOVA|||||||.307
71841654|NCT03655028|143193613|SUPERIORITY|||||||0.106||||||this comparison is made between distance walked during 6MW at 12 weeks and distance walked during 6MW at 24 weeks|ANCOVA|||||||0.106
71675396|NCT02099110|142868188|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.43|||<|0.001|TWO_SIDED|95.0|-0.6|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.60|<0.001
71675397|NCT02099110|142868188|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.61|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.27|-0.61|<0.001
71841655|NCT03655028|143193614|SUPERIORITY|||||||0.26||||||Baseline PCS score was used at the co-variate|ANCOVA|||||||0.26
71841656|NCT03655028|143193615|SUPERIORITY|||||||0.85||||||Covariate was baseline MCS score|ANCOVA|||||||0.85
71841657|NCT03655028|143193616|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
71841658|NCT05256654|143193630|SUPERIORITY||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|6.92||0.691|TWO_SIDED|95.0|-15.5|11.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (Triglycerides (TG) \<250 milligram per deciliter (mg/dL) or \>=250 mg/dL at screening), and the interaction between treatment and time.|||11.9|-15.5|0.691
71841659|NCT05256654|143193630|SUPERIORITY||Mean Difference (Net)|-14.3|STANDARD_ERROR_OF_MEAN|4.98||0.008|TWO_SIDED|95.0|-23.6|-3.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-3.9|-23.6|0.008
71841660|NCT05256654|143193630|SUPERIORITY||Mean Difference (Net)|-8.3|STANDARD_ERROR_OF_MEAN|5.36||0.14|TWO_SIDED|95.0|-18.3|2.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.9|-18.3|0.140
71841661|NCT05256654|143193631|SUPERIORITY||Mean Difference (Net)|-54.3|STANDARD_ERROR_OF_MEAN|5.08|<|0.001|TWO_SIDED|95.0|-63.3|-43.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.1|-63.3|<.001
71841662|NCT05256654|143193631|SUPERIORITY||Mean Difference (Net)|-69.8|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-74.8|-63.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-63.9|-74.8|<.001
71841663|NCT05256654|143193631|SUPERIORITY||Mean Difference (Net)|-76.6|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-80.4|-72.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-72.0|-80.4|<.001
71841664|NCT05256654|143193632|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|7.24||0.854|TWO_SIDED|95.0|-14.6|14.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||14.0|-14.6|0.854
71841665|NCT05256654|143193632|SUPERIORITY||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|4.98||0.002|TWO_SIDED|95.0|-26.0|-6.4|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.4|-26.0|0.002
71841666|NCT05256654|143193632|SUPERIORITY||Mean Difference (Net)|-12.1|STANDARD_ERROR_OF_MEAN|5.28||0.033|TWO_SIDED|95.0|-21.9|-1.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.1|-21.9|0.033
71841667|NCT05256654|143193633|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|4.03||0.143|TWO_SIDED|95.0|-13.8|2.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.2|-13.8|0.143
71841668|NCT05256654|143193633|SUPERIORITY||Mean Difference (Net)|-16.4|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-22.0|-10.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-10.5|-22.0|<.001
71841669|NCT05256654|143193633|SUPERIORITY||Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-27.9|-17.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.2|-27.9|<.001
71841670|NCT05256654|143193634|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|5.55||0.068|TWO_SIDED|95.0|-21.1|0.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||0.9|-21.1|0.068
71841671|NCT05256654|143193634|SUPERIORITY||Mean Difference (Net)|-25.5|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-32.6|-17.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-17.6|-32.6|<.001
71804566|NCT00856583|143108806|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% confidence interval (CI) for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 patient years of exposure (PYE) were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|1.117||||0.05|TWO_SIDED|90.0|0.831|1.5|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.||1.500|0.831|0.05
71804567|NCT00856583|143108806|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 90% CI for the estimated all-cause mortality ratio was \<1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 PYE were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|0.98|||<|0.05|TWO_SIDED|90.0|0.684|1.405|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.||1.405|0.684|<0.05
71804568|NCT00856583|143108807|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.84||||0.0022|TWO_SIDED|95.0|1.45|5.55|||Cox Proportional Hazard|Adjusted: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), region, year since start of enrollment||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||5.55|1.45|0.0022
71804569|NCT00856583|143108808|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.63|4.78|||Cox Proportional Hazard|Adjusted for: age and sex.||The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.78|0.63|0.29
71804570|NCT00856583|143108809|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.34|TWO_SIDED|95.0|0.36|1.41|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.41|0.36|0.34
71804571|NCT00856583|143108810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715||||0.26|TWO_SIDED|95.0|0.4|1.28|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.28|0.40|0.26
71804572|NCT00856583|143108811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.13||||0.081|TWO_SIDED|95.0|0.91|4.98|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy).||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||4.98|0.91|0.081
71804573|NCT00856583|143108812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.24|TWO_SIDED|95.0|0.33|1.32|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.32|0.33|0.24
71841672|NCT05256654|143193634|SUPERIORITY||Mean Difference (Net)|-23.8|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-31.1|-15.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-15.7|-31.1|<.001
71841673|NCT05256654|143193635|SUPERIORITY||Mean Difference (Net)|-36.3|STANDARD_ERROR_OF_MEAN|5.21|<|0.001|TWO_SIDED|95.0|-45.8|-25.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-25.1|-45.8|<.001
71841674|NCT05256654|143193635|SUPERIORITY||Mean Difference (Net)|-50.3|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-56.4|-43.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.3|-56.4|<.001
71841675|NCT05256654|143193635|SUPERIORITY||Mean Difference (Net)|-52.5|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-58.4|-45.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-45.9|-58.4|<.001
71841676|NCT05256654|143193636|SUPERIORITY||Mean Difference (Net)|-38.6|STANDARD_ERROR_OF_MEAN|7.76|<|0.001|TWO_SIDED|95.0|-52.2|-21.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-21.2|-52.2|<.001
71841677|NCT05256654|143193636|SUPERIORITY||Mean Difference (Net)|-54.0|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-62.4|-43.8|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-43.8|-62.4|<.001
71804574|NCT00856583|143108813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.59|TWO_SIDED|95.0|0.7|1.85|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.85|0.70|0.59
71804575|NCT00856583|143108814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.29|0.66|0.65
71804576|NCT00856583|143108815|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.044|TWO_SIDED|95.0|0.45|0.99|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||0.99|0.45|0.044
71804577|NCT00856583|143108816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.04|TWO_SIDED|95.0|1.01|1.57|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.57|1.01|0.040
71804578|NCT00856583|143108817|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.28|1.43|||Cox Proportional Hazard|Adjusted: disease duration, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.||1.43|1.28|<0.0001
71804579|NCT01944046|143108821|SUPERIORITY|||||||0.503||||||not adjusted primary outcome|Mixed Models Analysis|adjusted for baseline, age category, functionality category||||||0.503
71841678|NCT05256654|143193636|SUPERIORITY||Mean Difference (Net)|-63.6|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-70.3|55.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||55.5|-70.3|<.001
71841679|NCT05256654|143193637|SUPERIORITY||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|5.99||0.506|TWO_SIDED|95.0|-15.2|8.5|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||8.5|-15.2|0.506
71675398|NCT02099110|142868188|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.47|||<|0.001|TWO_SIDED|95.0|-0.63|-0.3||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.30|-0.63|<0.001
71804580|NCT01944046|143108822|SUPERIORITY|||||||0.61||||||not adjusted primary outcome, p threshold 0.05|Mixed Models Analysis|adjustment for value at week 24,||||||0.61
71804581|NCT00823082|143108837|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71804582|NCT00823082|143108838|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71841680|NCT05256654|143193637|SUPERIORITY||Mean Difference (Net)|-19.7|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-27.2|-11.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.3|-27.2|<.001
71841681|NCT05256654|143193637|SUPERIORITY||Mean Difference (Net)|-19.4|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-27.0|-11.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-11.0|-27.0|<.001
71841682|NCT05256654|143193638|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|4.16||0.428|TWO_SIDED|95.0|-11.2|5.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||5.2|-11.2|0.428
71841683|NCT05256654|143193638|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_ERROR_OF_MEAN|3.14||0.009|TWO_SIDED|95.0|-14.7|-2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-2.3|-14.7|0.009
71841684|NCT05256654|143193638|SUPERIORITY||Mean Difference (Net)|-12.2|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-18.0|-6.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-6.0|-18.0|<.001
71841685|NCT05256654|143193639|SUPERIORITY||Mean Difference (Net)|6.5|STANDARD_ERROR_OF_MEAN|8.1||0.412|TWO_SIDED|95.0|-8.4|23.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||23.7|-8.4|0.412
71804583|NCT00823082|143108839|SUPERIORITY_OR_OTHER|||||||0.6115|TWO_SIDED||||||Fisher Exact|||At ICU discharge visit||||0.6115
71804584|NCT00823082|143108840|SUPERIORITY_OR_OTHER|||||||0.1211|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||0.1211
71804585|NCT00823082|143108840|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||1.000
71804586|NCT00823082|143108841|SUPERIORITY_OR_OTHER|||||||0.487|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.4870
71804587|NCT00823082|143108842|SUPERIORITY_OR_OTHER|||||||0.3897|TWO_SIDED||||||Hodges-Lehmann test|||||||0.3897
71804588|NCT00823082|143108843|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
71804589|NCT00823082|143108844|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||||||0.0004
71804590|NCT00823082|143108845|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||ANCOVA|||||||0.0209
71804591|NCT00823082|143108846|SUPERIORITY_OR_OTHER|||||||0.7433|TWO_SIDED||||||ANCOVA|||Number of units of packed red blood cells||||0.7433
71804592|NCT00823082|143108846|SUPERIORITY_OR_OTHER|||||||0.7453|TWO_SIDED||||||ANCOVA|||Units of fresh frozen plasma||||0.7453
71804593|NCT00823082|143108846|SUPERIORITY_OR_OTHER|||||||0.2705|TWO_SIDED||||||ANCOVA|||Units of platelets||||0.2705
71804594|NCT00823082|143108847|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||||||0.4460
71804595|NCT00823082|143108848|SUPERIORITY_OR_OTHER|||||||0.4936|TWO_SIDED||||||Fisher Exact|||||||0.4936
71804596|NCT00823082|143108849|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Follow-up visit||||1.000
71804597|NCT00823082|143108849|SUPERIORITY_OR_OTHER|||||||0.6218|TWO_SIDED||||||Fisher Exact|||ICU discharge visit||||0.6218
71804598|NCT00823082|143108850|SUPERIORITY_OR_OTHER|||||||0.9574|TWO_SIDED||||||Hodges-Lehmann|||||||0.9574
71804599|NCT00823082|143108851|SUPERIORITY_OR_OTHER|||||||0.7489|||||||Hodges-Lehmann test|||||||0.7489
71804600|NCT02328326|143108852|SUPERIORITY||Mean Difference (Net)|2.6||||0.048|TWO_SIDED|95.0|0.02|5.18|||Regression, Linear|Model was adjusted for baseline value of PAM, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAM is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAM score compared to patient participants in PACT.||5.18|0.02|0.048
71804601|NCT02328326|143108853|SUPERIORITY||Mean Difference (Net)|0.9||||0.32|TWO_SIDED|95.0|-0.87|2.67|||Regression, Linear|Model adjusted for baseline value of ukpds, insulin use, site, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline. Reference for comparison is PACT.|The null hypothesis was that change (baseline to 12 months) in ukpds 5 year risk score is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' 5-year cardiovascular event risk.||2.67|-0.87|0.32
71804602|NCT02328326|143108854|SUPERIORITY||Mean Difference (Net)|0.71||||0.01|TWO_SIDED|95.0|0.2|1.22|||Regression, Linear|Model adjusted for BL value of Healthy Eating, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Healthy Eating is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' Healthy Eating scores compared to patient participants in PACT.||1.22|0.20|0.01
71804603|NCT02328326|143108855|SUPERIORITY||Mean Difference (Net)|0.17||||0.33|TWO_SIDED|95.0|-0.17|0.51|||Regression, Linear|Model was adjusted for baseline value of A1c, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in A1c is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' A1c score compared to patient participants in PACT.||0.51|-0.17|0.33
71804604|NCT02328326|143108856|SUPERIORITY||Mean Difference (Net)|-2.82||||0.18|TWO_SIDED|95.0|-7.0|1.35|||Regression, Linear|Model was adjusted for baseline value of SBP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SBP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' SBP score compared to patient participants in PACT.||1.35|-7.00|0.18
71804605|NCT02328326|143108857|SUPERIORITY||Mean Difference (Net)|0.12||||0.83|TWO_SIDED|95.0|-0.95|1.19|||Regression, Linear|Model was adjusted for baseline value of PAID, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID score compared to patient participants in PACT.||1.19|-0.95|0.83
71804606|NCT02328326|143108858|SUPERIORITY||Mean Difference (Net)|0.11||||0.79|TWO_SIDED|95.0|-0.71|0.93|||Regression, Linear|Model was adjusted for baseline value of PEPPI, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PEPPI is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PEPPI score compared to patient participants in PACT.||0.93|-0.71|0.79
71804607|NCT02328326|143108859|SUPERIORITY||Median Difference (Net)|0.15||||0.21|TWO_SIDED|95.0|-0.09|0.4|||Regression, Linear|Model adjusted for BL value of Cho to HDL Ratio, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40.|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Chol to HDL Ratio is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly decrease patient participants' Chol to HDL Ratio score compared to patient participants in PACT.||0.40|-0.09|0.21
71804608|NCT02328326|143108861|SUPERIORITY||Mean Difference (Net)|0.3||||0.01|TWO_SIDED|95.0|0.08|0.53|||Regression, Linear|Model was adjusted for baseline value of IOCQ, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in IOCQ is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' IOCQ score compared to patient participants in PACT.||0.53|0.08|0.01
71841686|NCT05256654|143193639|SUPERIORITY||Mean Difference (Net)|-9.5|STANDARD_ERROR_OF_MEAN|5.52||0.104|TWO_SIDED|95.0|-19.7|2.1|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.1|-19.7|0.104
71841687|NCT05256654|143193639|SUPERIORITY||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|5.79||0.363|TWO_SIDED|95.0|-16.2|6.7|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||6.7|-16.2|0.363
71841688|NCT05256654|143193640|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|6.19||0.101|TWO_SIDED|95.0|-22.2|2.3|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||2.3|-22.2|0.101
71841689|NCT05256654|143193640|SUPERIORITY||Mean Difference (Net)|-11.3|STANDARD_ERROR_OF_MEAN|4.96||0.033|TWO_SIDED|95.0|-20.6|-1.0|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-1.0|-20.6|0.033
71841690|NCT05256654|143193640|SUPERIORITY||Mean Difference (Net)|-10.9|STANDARD_ERROR_OF_MEAN|4.98||0.04|TWO_SIDED|95.0|-20.3|-0.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-0.6|-20.3|0.040
71841691|NCT05256654|143193641|SUPERIORITY||Mean Difference (Net)|-28.3|STANDARD_ERROR_OF_MEAN|6.79|<|0.001|TWO_SIDED|95.0|-40.5|-13.6|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-13.6|-40.5|<.001
71841692|NCT05256654|143193641|SUPERIORITY||Mean Difference (Net)|-42.5|STANDARD_ERROR_OF_MEAN|4.35|<|0.001|TWO_SIDED|95.0|-50.5|-33.2|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-33.2|-50.5|<.001
71841693|NCT05256654|143193641|SUPERIORITY||Mean Difference (Net)|-44.8|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-52.5|-35.9|||Mixed Models Analysis||Model uses log-transformed outcome and baseline variables, including terms for baseline, strata (TG \<250 mg/dL or \>=250 mg/dL at screening), and the interaction between treatment and time.|||-35.9|-52.5|<.001
71841694|NCT05618587|143193643|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71841695|NCT05618587|143193644|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71841696|NCT05618587|143193645|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||||||0.68
71841697|NCT05618587|143193646|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||||||0.89
71841698|NCT05618587|143193647|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
71841699|NCT05618587|143193648|SUPERIORITY|||||||1|||||||Barnard unconditional exact test|||||||1.0
71675399|NCT02099110|142868189|SUPERIORITY_OR_OTHER||Difference in % vs Ertugliflozin 5 mg|-3.2|||||TWO_SIDED|95.0|-11.7|5.5|||||Based on Miettinen \& Nurminen method.|||5.5|-11.7|
71675400|NCT02099110|142868189|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|-1.9|||||TWO_SIDED|95.0|-10.6|6.8|||||Based on Miettinen \& Nurminen method.|||6.8|-10.6|
71675401|NCT02099110|142868189|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|1.4|||||TWO_SIDED|95.0|-7.4|10.1|||||Based on Miettinen \& Nurminen method.|||10.1|-7.4|
71841700|NCT05618587|143193649|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71841701|NCT05618587|143193650|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71841702|NCT05618587|143193651|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71841703|NCT05618587|143193652|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
71841704|NCT05618587|143193653|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||||||0.29
71841705|NCT05618587|143193654|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.35
71841706|NCT05167864|143193663|SUPERIORITY|||||||0.13519|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.13519
71841707|NCT05167864|143193663|SUPERIORITY|||||||0.8556|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.8556
71841708|NCT05167864|143193663|SUPERIORITY|||||||0.46943|TWO_SIDED|95.0|||||Wilcoxon signed-rank test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.46943
71841709|NCT05167864|143193663|SUPERIORITY|||||||0.0449|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 3|||0.0449
71841710|NCT05167864|143193663|SUPERIORITY|||||||0.504|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.504
71841711|NCT05167864|143193663|SUPERIORITY|||||||0.772193|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.772193
71841712|NCT05167864|143193663|SUPERIORITY|||||||0.5414|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.5414
71841713|NCT05167864|143193663|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||Wilcoxon signed-rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 30|||0.070
71841714|NCT05167864|143193663|SUPERIORITY|||||||0.546|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.546
71841715|NCT05167864|143193663|SUPERIORITY|||||||0.756|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.756
71894289|NCT01416181|143310651|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.0091|TWO_SIDED|95.0|0.39|0.87|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (non-dominant hand)||0.87|0.39|0.0091
71894290|NCT01416181|143310653|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.4369|TWO_SIDED|95.0|0.8|1.7|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6) and T25FW.|active/placebo|||1.70|0.80|0.4369
71894291|NCT01416181|143310654|SUPERIORITY_OR_OTHER|||||||0.5409|||||||ANCOVA|p-value for comparison between the active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL MSWS-12.||||||0.5409
71894292|NCT01416181|143310655|SUPERIORITY_OR_OTHER|||||||0.2586|||||||ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL ABILHAND.||||||0.2586
71675402|NCT02099110|142868189|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|-1.8|||||TWO_SIDED|95.0|-10.5|7.0|||||Based on Miettinen \& Nurminen method.|||7.0|-10.5|
71675403|NCT02099110|142868190|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 5 mg|0.1|||||TWO_SIDED|95.0|-3.3|3.6|||||Based on Miettinen \& Nurminen method.|||3.6|-3.3|
71804609|NCT02328326|143108862|EQUIVALENCE|Equivalent distribution among categories|difference in count|-1.0||||0.17|TWO_SIDED||||||Chi-squared||||Difference in count of those who stopped smoking in CO-IMPACT vs. those who stopped smoking in PACT.|||0.17
71804610|NCT02328326|143108863|SUPERIORITY||Mean Difference (Net)|-0.04||||0.87|TWO_SIDED|95.0|-0.56|0.47|||Regression, Linear|Model adjusted for BL value of Physical Activity, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Physical activity is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Physical activity score compared to patient participants in PACT.||0.47|-0.56|0.87
71804611|NCT02328326|143108864|SUPERIORITY||Mean Difference (Net)|0.23||||0.31|TWO_SIDED|95.0|-0.22|0.68|||Regression, Linear|Model adjusted for BL value of Blood Sugar Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Sugar Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Sugar Home Testing score compared to patient participants in PACT.||0.68|-0.22|0.31
71804612|NCT02328326|143108865|SUPERIORITY||Mean Difference (Net)|0.07||||0.87|TWO_SIDED|95.0|-0.76|0.89|||Regression, Linear|Model adjusted for BL value of Blood Pressure Home Testing, insulin use, randomization strat. variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Blood Pressure Home Testing is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Blood Pressure Home Testing score compared to patient participants in PACT.||0.89|-0.76|0.87
71804613|NCT02328326|143108866|SUPERIORITY||Mean Difference (Net)|-0.1||||0.56|TWO_SIDED|95.0|-0.42|0.23|||Regression, Linear|Model adjusted for BL value of Take Oral Meds as Prescribed, insulin use, randomization strat variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Oral Meds as Prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Oral Meds as Prescribed score compared to patient participants in PACT.||0.23|-0.42|0.56
71804614|NCT02328326|143108867|SUPERIORITY||Mean Difference (Net)|0.07||||0.67|TWO_SIDED|95.0|-0.26|0.41|||Regression, Linear|Model adjusted for baseline value of Take Insulin as Prescribed, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Take Insulin as prescribed is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Take Insulin as Prescribed compared to patient participants in PACT.||0.41|-0.26|0.67
71804615|NCT02328326|143108868|SUPERIORITY|The null hypothesis was that change (baseline to 12 months) in Foot Care is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Foot Care score compared to patient participants in PACT.|Median Difference (Net)|0.26||||0.29|TWO_SIDED|95.0|-0.22|0.75|||Regression, Linear|Model was adjusted for baseline value of Foot Care, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|||Net difference defined as 12 months minus baseline|0.75|-0.22|0.29
71804616|NCT02328326|143108869|SUPERIORITY||Mean Difference (Net)|0.4||||0.01|TWO_SIDED|95.0|0.09|0.71|||Regression, Linear|Model was adjusted for baseline value of SE, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in SE is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly change patient participants' SE scores compared to patient participants in PACT.||0.71|0.09|0.01
71804617|NCT02328326|143108870|SUPERIORITY||Mean Difference (Net)|0.1||||0.67|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|Model was adjusted for baseline value of Lorig\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in Lorig\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' Lorig\_CP score compared to patient participants in PACT.||0.55|-0.34|0.67
71894293|NCT01416181|143310656|SUPERIORITY_OR_OTHER|||||||0.1529|||||||ANCOVA|p-value for comparison between active \& placebo groups at Wk 96 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.1529
71675404|NCT02099110|142868190|SUPERIORITY_OR_OTHER||Difference in % vs. Ertugliflozin 15 mg|0.5|||||TWO_SIDED|95.0|-3.0|4.0|||||Based on Miettinen \& Nurminen method.|||4.0|-3.0|
71675405|NCT02099110|142868190|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.5|||||TWO_SIDED|95.0|-2.9|3.9|||||Based on Miettinen \& Nurminen method.|||3.9|-2.9|
71804618|NCT02328326|143108871|SUPERIORITY||Mean Difference (Net)|0.28||||0.53|TWO_SIDED|95.0|-0.6|1.16|||Regression, Linear||Net difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in CSIS is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' CSIS score compared to patient participants in PACT.||1.16|-0.60|0.53
71841716|NCT05167864|143193663|SUPERIORITY|||||||0.7|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.700
71804619|NCT02328326|143108872|SUPERIORITY||Mean Difference (Net)|0.32||||0.5|TWO_SIDED|95.0|-0.61|1.25|||Regression, Linear|Model was adjusted for baseline value of PAID\_CP, insulin use, randomization stratification variables: care partner not in home and PAM cutoff of 40|Net difference defined as 12 months minus baselineNet difference defined as 12 months minus baseline|The null hypothesis was that change (baseline to 12 months) in PAID\_CP is the same for CO-IMPACT (intervention) compared to PACT (control). The alternative hypothesis is that that COIMPACT will significantly increase patient participants' PAID\_CP score compared to patient participants in PACT.||1.25|-0.61|0.50
71841717|NCT05167864|143193663|SUPERIORITY|||||||0.397|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 90|||0.397
71894294|NCT01416181|143310657|SUPERIORITY_OR_OTHER|||||||0.2424||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or \>=6) and BL brain volume.||Only participants with BL brain volume are included in the p-value calculation.||||0.2424
71675406|NCT02099110|142868190|SUPERIORITY_OR_OTHER||Difference in % vs. Sitagliptin 100 mg|0.9|||||TWO_SIDED|95.0|-2.5|4.4|||||Based on Miettinen \& Nurminen method.|||4.4|-2.5|
71675407|NCT02099110|142868191|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.85|||<|0.001|TWO_SIDED|95.0|-2.48|-1.22||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.22|-2.48|<0.001
71675408|NCT02099110|142868191|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.27|||<|0.001|TWO_SIDED|95.0|-2.9|-1.64||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained logitudinal data analysis|||||-1.64|-2.90|<0.001
71804620|NCT03452917|143108877|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.82|ONE_SIDED|95.0|-8.0||||Chi-squared||||||-8.0|0.82
71804621|NCT03452917|143108877|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.66|ONE_SIDED|95.0|-6.5||||Chi-squared||||||-6.5|0.66
71841718|NCT05167864|143193663|SUPERIORITY|||||||0.093|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.093
71841719|NCT05167864|143193663|SUPERIORITY|||||||0.323|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.323
71841720|NCT05167864|143193663|SUPERIORITY|||||||0.182|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement of line in the forehead post injection day 180|||0.182
71841721|NCT05167864|143193663|SUPERIORITY|||||||0.88|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement of line in the forehead post injection day 180|||0.880
71841722|NCT05167864|143193663|SUPERIORITY|||||||0.496|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) tothe patient satisfaction improvement in the forehead post injection day 3|||0.496
71841723|NCT05167864|143193663|SUPERIORITY|||||||0.905|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.905
71841724|NCT05167864|143193663|SUPERIORITY|||||||0.692|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.692
71841725|NCT05167864|143193663|SUPERIORITY|||||||0.262|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 3|||0.262
71841726|NCT05167864|143193663|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.828
71841727|NCT05167864|143193663|SUPERIORITY|||||||0.268|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.268
71841728|NCT05167864|143193663|SUPERIORITY|||||||0.975|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.975
71841729|NCT05167864|143193663|SUPERIORITY|||||||0.499|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 30|||0.499
71675409|NCT02099110|142868192|SUPERIORITY_OR_OTHER||Difference in the least squares means|-8.23||||0.004|TWO_SIDED|95.0|-13.82|-2.65||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-2.65|-13.82|0.004
71841730|NCT05167864|143193663|SUPERIORITY|||||||0.75|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.750
71804622|NCT03452917|143108878|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.44|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.44
71804623|NCT03452917|143108878|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
71804624|NCT03452917|143108879|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.12|TWO_SIDED|95.0|-0.9|5.4|||Wilcoxon (Mann-Whitney)|||||5.4|-0.9|0.12
71804625|NCT03452917|143108879|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.41|TWO_SIDED|95.0|-2.5|3.6|||Wilcoxon (Mann-Whitney)|||||3.6|-2.5|0.41
71804626|NCT03452917|143108880|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.42|TWO_SIDED|95.0|-8.3|3.5|||Chi-squared|||||3.5|-8.3|0.42
71804627|NCT03452917|143108880|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.49|TWO_SIDED|95.0|-8.0|3.9|||Chi-squared|||||3.9|-8.0|0.49
71804628|NCT03452917|143108881|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.93|TWO_SIDED|95.0|-7.8|8.6|||Chi-squared|||||8.6|-7.8|0.93
71804629|NCT03452917|143108881|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.2|TWO_SIDED|95.0|-2.8|13.3|||Chi-squared|||||13.3|-2.8|0.20
71804630|NCT03452917|143108882|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5|TWO_SIDED|95.0|-7.7|3.8|||Chi-squared|||||3.8|-7.7|0.50
71804631|NCT03452917|143108882|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.48|TWO_SIDED|95.0|-7.8|3.7|||Chi-squared|||||3.7|-7.8|0.48
71804632|NCT03452917|143108883|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.49|TWO_SIDED|95.0|-6.0|2.6|||Chi-squared|||||2.6|-6.0|0.49
71804633|NCT03452917|143108883|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.85|TWO_SIDED|95.0|-4.9|4.0|||Chi-squared|||||4.0|-4.9|0.85
71804634|NCT03198000|143108884|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44).|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.049||0.392|TWO_SIDED|95.0|-0.14|0.055|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.055|-0.140|0.392
71804635|NCT03198000|143108884|EQUIVALENCE|Prespecified equivalence interval of (-0.22, 0.44)|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.049||0.828|TWO_SIDED|95.0|-0.086|0.107|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.107|-0.086|0.828
71804636|NCT03198000|143108885|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25).|Odds Ratio (OR)|0.87||||0.576|TWO_SIDED|95.0|0.539|1.411|||GEE model|GEE model with treatment as factor.||||1.411|0.539|0.576
71804637|NCT03198000|143108885|EQUIVALENCE|Prespecified equivalence interval of (0.80, 1.25)|Odds Ratio (OR)|0.87||||0.544|TWO_SIDED|95.0|0.552|1.368|||GEE model|GEE model with treatment as factor.||||1.368|0.552|0.544
71804638|NCT03198000|143108886|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.893|TWO_SIDED|95.0|-0.085|0.074|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.074|-0.085|0.893
71804639|NCT03198000|143108886|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.04||0.886|TWO_SIDED|95.0|-0.073|0.084|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.084|-0.073|0.886
71804640|NCT03198000|143108887|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.117|TWO_SIDED|95.0|-0.177|0.02|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.020|-0.177|0.117
71804641|NCT03198000|143108887|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.049||0.255|TWO_SIDED|95.0|-0.153|0.041|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.041|-0.153|0.255
71804642|NCT03198000|143108889|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.085|TWO_SIDED|95.0|-0.05|0.78|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.78|-0.05|0.085
71804643|NCT03198000|143108889|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.269|TWO_SIDED|95.0|-0.18|0.64|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.64|-0.18|0.269
71804644|NCT03198000|143108890|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.162|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.10|-0.60|0.162
71804645|NCT03198000|143108890|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234|TWO_SIDED|95.0|-0.55|0.14|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.14|-0.55|0.234
71804646|NCT03198000|143108891|EQUIVALENCE|No equivalence interval was specified.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.398|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.19|-0.48|0.398
71804647|NCT03198000|143108891|EQUIVALENCE|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.233|TWO_SIDED|95.0|-0.54|0.13|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.||||0.13|-0.54|0.233
71804648|NCT03965052|143108934|OTHER|||||||1|||||||Fisher Exact|||||||1.000
71804649|NCT03965052|143108936|OTHER|||||||1|||||||Fisher Exact|||Lissamine green treatment groups||||1.000
71804650|NCT03965052|143108936|OTHER|||||||0.667|||||||Fisher Exact|||Fluorescein treatment groups||||0.667
71804651|NCT03965052|143108937|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71804652|NCT03965052|143108938|OTHER|||||||0.977|||||||Chi-squared, Corrected|||the analysis was per protocol||||0.977
71804653|NCT03965052|143108940|OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||||||0.019
71804654|NCT00358735|143108953|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71804655|NCT00358735|143108954|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71804656|NCT00358735|143108955|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||||||0.0004
71804657|NCT00358735|143108957|SUPERIORITY_OR_OTHER|||||||0.953|||||||Chi-squared|||||||0.953
71804658|NCT00358735|143108958|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.050
71804659|NCT00358735|143108959|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
71804660|NCT00358735|143108960|SUPERIORITY_OR_OTHER|||||||0.507|||||||Chi-squared|||||||0.507
71675410|NCT02099110|142868192|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.79|||<|0.001|TWO_SIDED|95.0|-17.35|-6.23||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-6.23|-17.35|<0.001
71804661|NCT00358735|143108961|SUPERIORITY_OR_OTHER|||||||0.052|||||||Chi-squared|||||||0.052
71804662|NCT00358735|143108962|SUPERIORITY_OR_OTHER|||||||0.798|||||||Chi-squared|||||||0.798
71804663|NCT00358735|143108963|SUPERIORITY_OR_OTHER|||||||0.036|||||||Chi-squared|||||||0.036
71804664|NCT01910519|143108975|OTHER|||||||0.0039|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42||||0.0039
71804665|NCT01910519|143108975|OTHER|||||||0.0368|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42||||0.0368
71804666|NCT01910519|143108975|OTHER|||||||0.0465|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42||||0.0465
71804667|NCT01910519|143108975|OTHER|||||||0.0411|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42||||0.0411
71804668|NCT01910519|143108975|OTHER|||||||0.0067|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42||||0.0067
71804669|NCT04266028|143108976|OTHER|No statistical analyses were performed.|no statistical analyses were performed|0.0|||||TWO_SIDED|||||No statistical analyses were performed||||No statistical analyses were performed.|No statistical analyses were performed.|||
71804670|NCT01763567|143109019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|STANDARD_DEVIATION|9.5|||TWO_SIDED|||||||||||||
71804671|NCT01763567|143109020|SUPERIORITY_OR_OTHER||percent of events correctly detected|16.7|||||TWO_SIDED|||||||||||||
71804672|NCT01763567|143109021|SUPERIORITY_OR_OTHER||percent of events correctly detected|88.9|||||TWO_SIDED|||||||||||||
71804673|NCT01763567|143109022|SUPERIORITY_OR_OTHER||% of false alert|85.8|||||TWO_SIDED|||||||||||||
71804674|NCT01763567|143109023|SUPERIORITY_OR_OTHER||% of false alert|56.5|||||TWO_SIDED|||||||||||||
71804675|NCT04401579|143109038|SUPERIORITY||Cox Proportional Hazard|1.15||||0.047|TWO_SIDED|95.0|1.0|1.31|||Log Rank|||||1.31|1.00|0.047
71804676|NCT04401579|143109054|SUPERIORITY||Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-12.0|0.0||||||||0|-12|
71804677|NCT04401579|143109055|SUPERIORITY||Risk Difference (RD)|-5.0|||||TWO_SIDED|95.0|-10.0|0.0||||||||0|-10|
71804678|NCT04401579|143109065|SUPERIORITY||Odds Ratio (OR)|1.26||||0.44|TWO_SIDED|95.0|1.01|1.57|||Regression, Logistic|||||1.57|1.01|0.44
71804679|NCT04401579|143109075|SUPERIORITY||Cox Proportional Hazard|1.21||||0.002|TWO_SIDED|95.0|1.06|1.39|||Log Rank|||||1.39|1.06|0.002
71804680|NCT04401579|143109076|SUPERIORITY||Cox Proportional Hazard|1.2||||0.005|TWO_SIDED|95.0|1.05|1.38|||Log Rank|||||1.38|1.05|0.005
71804681|NCT04401579|143109077|SUPERIORITY||Cox Proportional Hazard|1.24||||0.003|TWO_SIDED|95.0|1.07|1.44|||Log Rank|||||1.44|1.07|0.003
71804682|NCT04401579|143109080|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.73|1.68||||||This analysis is for Asian participants.||1.68|0.73|
71804683|NCT04401579|143109080|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.75|1.5||||||This analysis is for Black or African American participants.||1.50|0.75|
71804684|NCT04401579|143109080|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.93|1.37||||||This analysis is for White participants.||1.37|0.93|
71804685|NCT04401579|143109080|SUPERIORITY||Cox Proportional Hazard|1.34|||||TWO_SIDED|95.0|1.03|1.74||||||This analysis is for Race of Other participants.||1.74|1.03|
71804686|NCT04401579|143109081|SUPERIORITY||Cox Proportional Hazard|1.31|||||TWO_SIDED|95.0|1.08|1.6||||||This analysis is for Not Hispanic or Latino participants||1.60|1.08|
71804687|NCT04401579|143109081|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.89|1.31||||||This analysis is for Hispanic or Latino participants.||1.31|0.89|
71804688|NCT04401579|143109082|SUPERIORITY||Cox Proportional Hazard|1.23|||||TWO_SIDED|95.0|1.04|1.46||||||This analysis is for Male participants.||1.46|1.04|
71804689|NCT04401579|143109082|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||This analysis is for Female participants.||1.32|0.85|
71804690|NCT00566228|143109103|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.08|||Log Rank|||||2.08|0.62|0.690
71804691|NCT00566228|143109106|SUPERIORITY|||||||0.679|||||||Log Rank|||||||0.679
71804692|NCT03521635|143109110|OTHER||Adjusted mean difference|0.7|STANDARD_ERROR_OF_MEAN|1.68||0.688|TWO_SIDED|95.0|-2.7|4.0|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release|Mean changes from baseline of PDSS-2 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||4.0|-2.7|0.688
71804693|NCT03521635|143109111|OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.69|TWO_SIDED|95.0|-1.2|0.8|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by patients were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.8|-1.2|0.690
71804694|NCT03521635|143109111|OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.91||0.376|TWO_SIDED|95.0|-2.7|1.1|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of NHQ score by caregivers were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.1|-2.7|0.376
71675411|NCT02099110|142868192|SUPERIORITY_OR_OTHER||Difference in the least squares means|-18.4|||<|0.001|TWO_SIDED|95.0|-24.03|-12.77||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-12.77|-24.03|<0.001
71675412|NCT02099110|142868192|SUPERIORITY_OR_OTHER||Difference in the least squares means|-23.14|||<|0.001|TWO_SIDED|95.0|-28.76|-17.53||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-17.53|-28.76|<0.001
71675413|NCT02099110|142868193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14|||<|0.001|TWO_SIDED|95.0|2.68|6.4||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||6.40|2.68|<0.001
71675414|NCT02099110|142868193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||<|0.001|TWO_SIDED|95.0|1.68|3.83||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||3.83|1.68|<0.001
71675415|NCT02099110|142868193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.92|4.54||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic|||||4.54|1.92|<0.001
71675416|NCT02099110|142868193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|95.0|1.69|3.89|||Regression, Logistic|Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.||||3.89|1.69|<0.001
71804695|NCT03521635|143109112|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.66||0.333|TWO_SIDED|95.0|-1.9|0.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep night-time sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.7|-1.9|0.333
71804696|NCT03521635|143109112|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.374|TWO_SIDED|95.0|-0.8|0.3|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep overall night sleep score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.3|-0.8|0.374
71804697|NCT03521635|143109112|OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.352|TWO_SIDED|95.0|-1.4|0.5|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of SCOPA-Sleep daytime sleepiness score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.5|-1.4|0.352
71841731|NCT05167864|143193663|SUPERIORITY|||||||0.433|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.433
71841732|NCT05167864|143193663|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
71841733|NCT05167864|143193663|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 90|||0.834
71841734|NCT05167864|143193663|SUPERIORITY|||||||0.526|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.526
71841735|NCT05167864|143193663|SUPERIORITY|||||||0.816|TWO_SIDED|95.0|||||Wilcoxon singed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.816
71841736|NCT05167864|143193663|SUPERIORITY|||||||0.65|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.650
71675417|NCT02099110|142868194|SUPERIORITY_OR_OTHER||Difference in the least squares means|7.61||||0.155|TWO_SIDED|95.0|-2.9|18.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||18.13|-2.90|0.155
71675418|NCT02099110|142868194|SUPERIORITY_OR_OTHER||Difference in the least squares means|-4.87||||0.369|TWO_SIDED|95.0|-15.54|5.8||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||5.80|-15.54|0.369
71675419|NCT02099110|142868194|SUPERIORITY_OR_OTHER||Difference in the least squares means|1.81||||0.734|TWO_SIDED|95.0|-8.66|12.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||12.27|-8.66|0.734
71675420|NCT02099110|142868194|SUPERIORITY_OR_OTHER||Difference in the least squares means|-9.59||||0.075|TWO_SIDED|95.0|-20.17|0.98||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the least squares means|||||0.98|-20.17|0.075
71675421|NCT02099110|142868195|SUPERIORITY_OR_OTHER||Difference in the least squares means|-2.76||||0.005|TWO_SIDED|95.0|-4.69|-0.83||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.83|-4.69|0.005
71841737|NCT05167864|143193663|SUPERIORITY|||||||0.095|TWO_SIDED|95.0|||||wilcoxon rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the forehead post injection day 180|||0.095
71841738|NCT05167864|143193663|SUPERIORITY|||||||0.618|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.618
71675422|NCT02099110|142868195|SUPERIORITY_OR_OTHER||Difference in the least squares means|-3.01||||0.002|TWO_SIDED|95.0|-4.94|-1.09||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-1.09|-4.94|0.002
71804698|NCT03521635|143109113|OTHER||Adjusted mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.259|TWO_SIDED|95.0|-0.8|0.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of EMO sore were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||0.2|-0.8|0.259
71804699|NCT03521635|143109114|OTHER||Odds Ratio (OR)|0.96||||0.9373|TWO_SIDED|95.0|0.36|2.54|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PDSS-2 score \<18 were performed with treatment and baseline as the independent variables.||2.54|0.36|0.9373
71804700|NCT03521635|143109115|OTHER||Odds Ratio (OR)|2.24||||0.1611|TWO_SIDED|95.0|0.73|7.49|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of EMO score were performed with treatment and baseline as the independent variables.||7.49|0.73|0.1611
71804701|NCT03521635|143109116|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.87||0.517|TWO_SIDED|95.0|-2.3|1.2|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of PDQ-8 score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.2|-2.3|0.517
71804702|NCT03521635|143109117|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of CGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
71804703|NCT03521635|143109118|OTHER||Odds Ratio (OR)|3.44||||0.2374|TWO_SIDED|95.0|0.57|36.85|||Regression, Logistic||The odds ratio (OR) between Pramipexole Sustained Release and Pramipexole Immediate Release groups.|Logistic regression analyses for responder rate at week 18 of PGI-I were performed with treatment as the independent variable.||36.85|0.57|0.2374
71804704|NCT03521635|143109119|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.82|TWO_SIDED|95.0|-1.4|1.7|||REML-based repeated measures approach|Restricted maximum likelihood (REML) - based repeated measures approach was applied.|Mean difference was calculated as Pramipexole Sustained Release minus Pramipexole immediate Release.|Mean changes from baseline of ESS score were analysed using a restricted maximum likelihood (REML) - based repeated measures approach. Analyses included the fixed, categorical effects of treatment, visit in the maintenance period, and treatment-by-visit interaction, and the continuous, fixed covariates of baseline and baseline-by-visit interaction.||1.7|-1.4|0.820
71804705|NCT00414700|143109129|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion||Test for superiority||||0.003
71804706|NCT00414700|143109130|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion.||Test for superiority||||0.010
71841739|NCT05167864|143193663|SUPERIORITY|||||||0.34|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.340
71894295|NCT01416181|143310658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.1052|TWO_SIDED|95.0|0.58|1.05|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (\<=5.5 or \>=6).||||1.05|0.58|0.1052
71841740|NCT05167864|143193663|SUPERIORITY|||||||0.15|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.150
71841741|NCT05167864|143193663|SUPERIORITY|||||||0.361|TWO_SIDED|95.0|||||Wilcoxon signed rank sum test||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 3|||0.361
71841742|NCT05167864|143193663|SUPERIORITY|||||||0.428|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.428
71841743|NCT05167864|143193663|SUPERIORITY|||||||0.834|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.834
71894296|NCT01416181|143310659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.0205|TWO_SIDED|95.0|0.47|0.94|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 156 weeks||0.94|0.47|0.0205
71675423|NCT00994461|142868209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.|Cochran-Mantel-Haenszel|CMH test stratified by H. pylori status was employed. Continuous correction was used.||Hypothesis testing was conducted with significant p-value level of under 0.05.||||<0.0001
71675424|NCT01377922|142868230|OTHER|Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline QMG score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||||0.0452|||||||Mixed Models Analysis|Pairwise contrast at Day 14 from MMRM model.||||||0.0452
71675425|NCT01377922|142868231|OTHER|||||||0.0028||||||Pairwise contrast at Day 14 from MMRM model.|Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline SGI score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0028
71804707|NCT00414700|143109131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -9 % points|Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|2.4||||95.0|-3.28|6.9|||ANCOVA|Adjusted for baseline Overall KOOS score, age, associated lesion(s) and location of lesion.||||6.90|-3.28|
71804708|NCT03073603|143109155|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0753||||0.521|TWO_SIDED|95.0|0.0063|0.15|||Exact binomial test|Exact binomial test for difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1500|0.0063|0.521
71804709|NCT03073603|143109156|SUPERIORITY|||||||0.766|||||||Chi-squared|||||||0.766
71804710|NCT03073603|143109157|SUPERIORITY|||||||0.604|||||||t-test, 2 sided|||||||0.604
71804711|NCT03073603|143109158|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||||||0.198
71804712|NCT03073603|143109159|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||||||0.354
71804713|NCT03073603|143109160|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|||||||0.831
71841744|NCT05167864|143193663|SUPERIORITY|||||||0.318|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.318
71675426|NCT01377922|142868232|OTHER|||||||0.6274|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline T25FW walking speed as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||0.6274
71804714|NCT03073603|143109161|SUPERIORITY|||||||0.252|||||||t-test, 2 sided|||||||0.252
71804715|NCT03073603|143109162|SUPERIORITY|||||||0.983|||||||t-test, 2 sided|||||||0.983
71804716|NCT03073603|143109163|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
71804717|NCT03073603|143109164|SUPERIORITY|||||||0.748|||||||t-test, 2 sided|||||||0.748
71804718|NCT03073603|143109165|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
71804719|NCT03073603|143109166|SUPERIORITY|||||||0.224|||||||t-test, 2 sided|||||||0.224
71804720|NCT03073603|143109167|SUPERIORITY|||||||0.962|||||||t-test, 2 sided|||||||0.962
71804721|NCT03073603|143109168|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71804722|NCT03073603|143109169|SUPERIORITY|||||||0.406|||||||t-test, 2 sided|||||||0.406
71804723|NCT03073603|143109170|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
71804724|NCT03073603|143109171|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||||||0.086
71804725|NCT03073603|143109172|SUPERIORITY|||||||0.575|||||||t-test, 2 sided|||||||0.575
71804726|NCT03073603|143109173|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
71804727|NCT03073603|143109174|SUPERIORITY|||||||0.733|||||||Chi-squared|||||||0.733
71804728|NCT03073603|143109175|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
71804729|NCT01659021|143109194|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.18|0.37||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).|Log Rank||Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.|||0.37|0.18|<0.0001
71804730|NCT01659021|143109195|SUPERIORITY||Odds Ratio (OR)|16.85|||<|0.0001|TWO_SIDED|95.0|8.17|34.76||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||34.76|8.17|<0.0001
71804731|NCT01659021|143109196|SUPERIORITY||Odds Ratio (OR)|483.16|||<|0.0001|TWO_SIDED|95.0|94.63|2467.02||P-value was calculated from the CMH Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.|||2467.02|94.63|<0.0001
71804732|NCT01659021|143109197|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.247|TWO_SIDED|95.0|0.54|1.15||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).|Log Rank|||||1.15|0.54|0.247
71804733|NCT01659021|143109198|OTHER||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.17|0.51|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.|||0.51|0.17|
71841745|NCT05167864|143193663|SUPERIORITY|||||||0.311|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 30|||0.311
71841746|NCT05167864|143193663|SUPERIORITY|||||||0.885|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.885
71841747|NCT05167864|143193663|SUPERIORITY|||||||0.457|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.457
71804734|NCT01169467|143109237|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||t-test, 2 sided|||||||0.395
71804735|NCT04827212|143109241|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.037|TWO_SIDED|||||P\<0.05|Mixed Models Analysis|||||||0.037
71841748|NCT05167864|143193663|SUPERIORITY|||||||0.745|TWO_SIDED|95.0|||||Wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.745
71841749|NCT05167864|143193663|SUPERIORITY|||||||0.757|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 90|||0.757
71841750|NCT05167864|143193663|SUPERIORITY|||||||0.562|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.562
71841751|NCT05167864|143193663|SUPERIORITY|||||||0.828|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.828
71675427|NCT01377922|142868233|OTHER|||||||0.0267|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction as fixed effects and patient as a random effect. The model assumed time effect to be random between patients||||0.0267
71804736|NCT04827212|143109242|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.78|TWO_SIDED|||||p-value is adjusted for multiple comparisons- P\<0.025; controlled for baseline values as there was a significant difference between groups at baseline|Mixed Models Analysis|||||||0.78
71804737|NCT04827212|143109243|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.56|TWO_SIDED|||||adjusted for multiple comparisons- P\<0.025; controlled for baseline value due to a significant difference between groups at baseline|Mixed Models Analysis|||||||0.56
71804738|NCT04827212|143109244|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.4
71804739|NCT04827212|143109245|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.18|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.18
71804740|NCT04827212|143109246|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.86
71804741|NCT04827212|143109247|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.21|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.21
71841752|NCT05167864|143193663|SUPERIORITY|||||||0.005|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.005
71804742|NCT04827212|143109248|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.19|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.19
71804743|NCT04827212|143109249|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
71804744|NCT04827212|143109250|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
71804745|NCT04827212|143109251|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.43|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.43
71894297|NCT01416181|143310659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1305|TWO_SIDED|95.0|0.48|1.1|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS at 156 weeks||1.10|0.48|0.1305
71804746|NCT04827212|143109252|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.53|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.53
71804747|NCT04827212|143109253|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.98|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.98
71804748|NCT04827212|143109254|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.96|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.96
71804749|NCT04827212|143109255|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.91|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.91
71804750|NCT04827212|143109256|SUPERIORITY||Mean Difference (Final Values)|13.1||||0.25|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.25
71804751|NCT04827212|143109257|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.46|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.46
71804752|NCT04827212|143109258|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.41|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.41
71804753|NCT04827212|143109259|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.12|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.12
71841753|NCT05167864|143193663|SUPERIORITY|||||||0.437|TWO_SIDED|95.0|||||wilcoxon signed rank sum||||the correlation of dynamic strain (decreased compression) to the patient satisfaction improvement in the lines between the eyebrows post injection day 180|||0.437
71841754|NCT03442309|143193669|NON_INFERIORITY|NI margin for arrest difference of 10%|Mean Difference (Final Values)|-0.11|||||TWO_SIDED|95.0|-0.22|0.01||||||||0.01|-.22|
71841755|NCT03442309|143193670|NON_INFERIORITY|Non-inferiority OR (OR δ, 0.63)|Odds Ratio (OR)|0.94|||||TWO_SIDED|90.0|0.82|1.08||||||||1.08|0.82|
71894298|NCT01416181|143310659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.1988|TWO_SIDED|95.0|0.57|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW at 156 weeks||1.12|0.57|0.1988
71894299|NCT01416181|143310659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.0093|TWO_SIDED|95.0|0.39|0.88|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (either hand) at 156 weeks||0.88|0.39|0.0093
71894300|NCT01416181|143310659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.054|TWO_SIDED|95.0|0.39|1.01|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors onm 9HPT (dominant hand) at 156 weeks||1.01|0.39|0.0540
71894301|NCT01416181|143310659|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.141|TWO_SIDED|95.0|0.44|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (\<=5.5 or \>=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (non-dominant hand) at 156 weeks||1.12|0.44|0.1410
71894302|NCT01416181|143310660|SUPERIORITY_OR_OTHER|||||||0.0273|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Week 156||||0.0273
71894303|NCT01416181|143310660|SUPERIORITY_OR_OTHER|||||||0.1974|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.1974
71894304|NCT01416181|143310660|SUPERIORITY_OR_OTHER|||||||0.2506|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2506
71894305|NCT01416181|143310661|SUPERIORITY_OR_OTHER|||||||0.096|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||Overall: Week 156||||0.0960
71675428|NCT00570063|142868299|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.61|STANDARD_ERROR_OF_MEAN|8.94||0.86|TWO_SIDED|90.0|-16.49|13.27|||Mixed Models Analysis|||P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||13.27|-16.49|0.86
71675429|NCT00570063|142868300|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|2.69||0.65|TWO_SIDED|90.0|-5.71|3.24|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.24|-5.71|0.65
71675430|NCT00570063|142868301|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|2.61||0.93|TWO_SIDED|90.0|-4.59|4.1|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.10|-4.59|0.93
71804754|NCT04827212|143109260|SUPERIORITY||Mean Difference (Final Values)|-11.9||||0.2|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.20
71804755|NCT04827212|143109261|SUPERIORITY||Mean Difference (Final Values)|-14.0||||0.13|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.13
71804756|NCT04827212|143109262|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.94|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.94
71804757|NCT04827212|143109263|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.72|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.72
71804758|NCT04827212|143109264|SUPERIORITY||Mean Difference (Final Values)|12.3||||0.33|TWO_SIDED|||||p-value is adjusted for multiple comparisons and significance threshold was set at P\<0.0167|Mixed Models Analysis|||||||0.33
71804759|NCT03108924|143109270|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.53|1.13||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.13|0.53|
71804760|NCT03108924|143109273|OTHER||GMR|2.98|||||TWO_SIDED|90.0|2.01|4.41||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||4.41|2.01|
71804761|NCT03108924|143109273|OTHER||GMR|4.43|||||TWO_SIDED|95.0|2.82|6.96||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.96|2.82|
71804762|NCT03108924|143109273|OTHER||GMR|4.74|||||TWO_SIDED|90.0|2.95|7.59||||Categorical Analysis|GMR = GM for ESRD HD / GM for Healthy Controls|||7.59|2.95|
71804763|NCT03108924|143109275|OTHER||GMR|0.77|||||TWO_SIDED|90.0|0.54|1.08||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.08|0.54|
71804764|NCT03108924|143109278|OTHER||GMR|3.23|||||TWO_SIDED|90.0|2.01|5.2||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||5.20|2.01|
71804765|NCT03108924|143109278|OTHER||GMR|4.08|||||TWO_SIDED|90.0|2.49|6.7||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||6.70|2.49|
71804766|NCT03108924|143109278|OTHER||GMR|4.43|||||TWO_SIDED|90.0|2.65|7.39||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||7.39|2.65|
71804767|NCT03108924|143109280|OTHER||GMR|0.73|||||TWO_SIDED|90.0|0.52|1.03||||Categorical Analysis|GMR = GM for ESRD HD / GM for ESRD Non-HD|||1.03|0.52|
71804768|NCT03108924|143109283|OTHER||GMR|2.09|||||TWO_SIDED|90.0|1.22|3.56||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||3.56|1.22|
71804769|NCT03108924|143109283|OTHER||GMR|1.89|||||TWO_SIDED|95.0|1.1|3.25||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||3.25|1.10|
71804770|NCT03108924|143109283|OTHER||GMR|1.9|||||TWO_SIDED|90.0|1.13|3.19||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||3.19|1.13|
71804771|NCT03108924|143109285|OTHER||GMR|1.3|||||TWO_SIDED|90.0|0.88|1.9||||Categorical Analysis|GMR = GM for ESRD / GM for ESRD Non-HD|||1.90|0.88|
71804772|NCT03108924|143109288|OTHER||GMR|0.34|||||TWO_SIDED|95.0|0.23|0.5||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.50|0.23|
71894306|NCT01416181|143310661|SUPERIORITY_OR_OTHER|||||||0.4957|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||CP Group: Week 156||||0.4957
71894307|NCT01416181|143310661|SUPERIORITY_OR_OTHER|||||||0.2916|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL T25FW.||NP Group: Week 156||||0.2916
71894308|NCT01416181|143310662|SUPERIORITY_OR_OTHER|||||||0.1119|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall, Week 156||||0.1119
71675431|NCT00570063|142868302|SUPERIORITY_OR_OTHER||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|4.18||0.86|TWO_SIDED|90.0|-6.21|7.69|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||7.69|-6.21|0.86
71804773|NCT03108924|143109288|OTHER||GMR|0.23|||||TWO_SIDED|95.0|0.14|0.35||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.35|0.14|
71804774|NCT03108924|143109288|OTHER||GMR|0.21|||||TWO_SIDED|95.0|0.13|0.34||||Categorical Analysis|GMR = GM for ESRD Non-HD / GM for Healthy Controls|||0.34|0.13|
71804775|NCT03108924|143109290|OTHER||GMR|0.31|||||TWO_SIDED|90.0|0.25|0.39||||Categorical Analysis|GMR = GM for Moderate RI / GM for Healthy Controls|||0.39|0.25|
71804776|NCT03108924|143109290|OTHER||GMR|0.1|||||TWO_SIDED|90.0|0.07|0.16||||Categorical Analysis|GMR = GM for Severe RI / GM for Healthy Controls|||0.16|0.07|
71804777|NCT00924885|143109314|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The primary end-point was the 'overall pain experience', evaluated as described previously. Assuming the mean overall pain in the RN group to be 27 mm (value chosen after analysis of data from a previous study, Cerne et al., 2006) on VAS, with a standard deviation (SD) of 21.5 mm, 121 patients in each group would be needed to demonstrate a decrease in overall pain of 8 mm (30%) with 80% power and a significance level of 0.05 (two-tailed tests).||||0.04
71804778|NCT00784810|143109316|NON_INFERIORITY_OR_EQUIVALENCE|As above.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|1.19||0.002|ONE_SIDED|90.0|-5.65||||Mixed Models Analysis|||To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.|||-5.65|0.002
71804779|NCT02508480|143109327|SUPERIORITY|||||||0.66|||||||Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect.||||0.66
71804780|NCT02508480|143109328|SUPERIORITY|||||||0.884||||||Group effect for Proactive Coping|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Proactive Coping."||||0.884
71804781|NCT02508480|143109328|SUPERIORITY|||||||0.543||||||Group effect for Avoidant Coping.|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Avoidant Coping."||||0.543
71841756|NCT05207982|143193687|OTHER|||||||||||||||||This study utilized a multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling. Separate models were developed for each participant which include the daily weights from the baseline, treatment and follow-up phases. Given the nature of the data, we hypothesized different slopes for the baseline vs treatment phases. Overall weight change was a primary outcome measure.|Multiple baseline single case experimental design in which analysis of the daily weights (for each participant) involved discontinuous growth curve analysis using multi-level modeling.|||
71841757|NCT04089059|143193694|SUPERIORITY|Poisson regression for comparison of incidence rate against performance goal (0.43)|||||<|0.0001|||||||Poisson Regression|||||||<0.0001
71841758|NCT04089059|143193697|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison of HF Hospitalization events 6 months before implant vs 6 months after implant||||<0.0001
71841759|NCT04089059|143193698|SUPERIORITY|Comparison of the incidence rate of HF hospitalizations or emergency department / hospital outpatient IV diuretic visits of Former Control Arm versus Modified Intent to Treat Arm at 6 months post-implant/Subgroup Analysis||||||0.0697|||||||Poisson Regression|||||||0.0697
71894309|NCT01416181|143310662|SUPERIORITY_OR_OTHER|||||||0.1129|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.1129
71894310|NCT01416181|143310662|SUPERIORITY_OR_OTHER|||||||0.2351|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.2351
71804782|NCT02508480|143109329|SUPERIORITY|||||||0.135||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.135
71804783|NCT02508480|143109330|SUPERIORITY|||||||0.25||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the interpersonal function subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.25
71804784|NCT02508480|143109330|SUPERIORITY|||||||0.118||||||The p-value represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the intrapsychic foundations subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.118
71804785|NCT02508480|143109331|SUPERIORITY|||||||0.917||||||The p-value is for group effect for tcpm\_days\_participated.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect for tcpm\_days\_participated.||||0.917
71841760|NCT04089059|143193701|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.0952|||||||Wilcoxon (Mann-Whitney)|||||||0.0952
71841761|NCT04089059|143193701|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.0090
71841762|NCT04089059|143193701|SUPERIORITY|Comparison of mPAP values at baseline to values at 6 months.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71841763|NCT04089059|143193703|SUPERIORITY|Comparison of KCCQ at baseline and at 6 months||||||0.0026|||||||Wilcoxon (Mann-Whitney)|||||||0.0026
71894311|NCT01416181|143310663|SUPERIORITY_OR_OTHER|||||||0.0261|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||Overall: Week 156||||0.0261
71675432|NCT00570063|142868303|SUPERIORITY_OR_OTHER||LS mean difference|-2.57|STANDARD_ERROR_OF_MEAN|3.22||0.43|TWO_SIDED|90.0|-7.92|2.79|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.79|-7.92|0.43
71675433|NCT00570063|142868304|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.68||0.91|TWO_SIDED|90.0|-4.76|4.16|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.16|-4.76|0.91
71675434|NCT00570063|142868305|SUPERIORITY_OR_OTHER||LS mean difference|0.63|STANDARD_ERROR_OF_MEAN|2.29||0.78|TWO_SIDED|90.0|-3.17|4.43|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||4.43|-3.17|0.78
71675435|NCT00570063|142868306|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.35||0.92|TWO_SIDED|90.0|-2.11|2.39|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||2.39|-2.11|0.92
71804786|NCT02508480|143109332|SUPERIORITY|||||||0.017||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.017
71804787|NCT02508480|143109333|SUPERIORITY|||||||0.597||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.597
71804788|NCT02508480|143109334|SUPERIORITY|||||||0.076||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.076
71804789|NCT02508480|143109335|SUPERIORITY|||||||0.978||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.||||0.978
71804790|NCT00304070|143109368|OTHER||2 Year EFS|0.89||||0.44|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.44
71804791|NCT00304070|143109368|OTHER||2 Year EFS|0.53||||0.4|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.40
71804792|NCT00304070|143109368|OTHER||2 Year EFS|0.55||||8.53e-06|TWO_SIDED|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.||||0.00000853
71804793|NCT00320216|143109375|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi square test|Stratified by baseline weight \[\<=90kg vs \> 90 kg\].||||||<0.001
71804794|NCT00320216|143109375|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71804795|NCT00320216|143109375|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71804796|NCT00320216|143109375|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis:No difference between any ustekinumab group and placebo at an overall significant level of 0.05. Sample Size: With 300 participants (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in primary endpoint between ustekinumab groups and placebo using a CMH test with stratification by baseline weight \[≤ 90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.01
71804797|NCT00320216|143109376|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71804798|NCT00320216|143109376|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71804799|NCT00320216|143109376|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|||||||<0.001
71804800|NCT00320216|143109376|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between any ustekinumab group and placebo.||||<0.001
71804801|NCT00377676|143109383|NON_INFERIORITY_OR_EQUIVALENCE|In order to test the primary hypothesis at a one-sided alpha = .05 and have a power of 0.9, when the non-inferiority margin is 1.5, the total number of subjects with all-cause SAEs that must be observed during the study was found to be 235. Assuming the placebo rate is 0.08, the required sample size was found to be 2991.|Hazard Ratio (HR)|1.02|||<|0.05|ONE_SIDED|95.0||1.27||Using the Lan and Demets alpha spending function for O'Brien-Fleming boundaries and the overall one-sided significance level of 5%, a level of 0.04068 was to be used at the interim analysis and 0.03938 at the time of the final analysis.|Regression, Cox||cycloset to placebo|||1.27||<0.05
71804802|NCT00377676|143109384|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.58|||<|0.05|TWO_SIDED|95.0|0.35|0.96|||Regression, Cox|||In order to test the hypothesis for serious cardiovascular adverse events as for the primary endpoint at a one-sided alpha = 0.5 when the non-inferiority margin is 1.5, the final sample size of 3000 to 3300 subjects was to provide at least 62% power, assuming a hypothetical rate of events of 3.43%, or 103 to 113 cardiovascular SAEs. Upon demonstration of non-inferiority - a 2 sided using 95% CI was used to assess for superiority.||.96|.35|<0.05
71675436|NCT00570063|142868307|SUPERIORITY_OR_OTHER||LS mean difference|0.84|STANDARD_ERROR_OF_MEAN|1.62||0.6|TWO_SIDED|90.0|-1.85|3.54|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.54|-1.85|0.60
71675437|NCT00570063|142868308|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.86||0.81|TWO_SIDED|90.0|-2.65|3.53|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||3.53|-2.65|0.81
71675438|NCT00570063|142868309|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.48||0.93|TWO_SIDED|90.0|-0.84|0.76|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.||0.76|-0.84|0.93
71675439|NCT00570063|142868310|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.68||0.99|TWO_SIDED|90.0|-1.13|1.14|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP\[POW\]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.||1.14|-1.13|0.99
71675440|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.158|STANDARD_DEVIATION|0.844|||TWO_SIDED|90.0|-1.546|1.231||||||Change at Day 21: Cried||1.231|-1.546|
71675441|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.444|STANDARD_DEVIATION|1.078|||TWO_SIDED|90.0|-1.329|2.218||||||Change at Day 21: Felt blue or depressed||2.218|-1.329|
71675442|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.544|STANDARD_DEVIATION|4.32|||TWO_SIDED|90.0|-5.561|8.649||||||Change at Day 21: Irritability||8.649|-5.561|
71675443|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.573|STANDARD_DEVIATION|2.955|||TWO_SIDED|90.0|-4.287|5.433||||||Change at Day 21: Manifest psychosis||5.433|-4.287|
71675444|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.556|STANDARD_DEVIATION|2.096|||TWO_SIDED|90.0|-2.892|4.003||||||Change at Day 21: Personal neatness||4.003|-2.892|
71804803|NCT00377676|143109385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.4|<|0.001|||||||ANOVA|||If the standard deviation of HbA1c level is about 1.0% and the baseline and 24 week scores have a correlation of 0.50 then the effect size is 0.5%/1.0% = 0.50. For the metformin/SU analysis, 160 subjects assuming a standard deviation of 1.0% would provide a power of 90% power to detect differences in mean changes of 0.5% or larger.||||<0.001
71804804|NCT00377676|143109386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||<|0.001|||||||ANOVA|||||||<0.001
71804805|NCT00148343|143109389|SUPERIORITY_OR_OTHER||Slope|1.26|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-0.2|2.75|||||Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks|||2.75|-0.2|
71675445|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.327|STANDARD_DEVIATION|0.532|||TWO_SIDED|90.0|-1.202|0.547||||||Change at Day 21: Refused to speak||0.547|-1.202|
71675446|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.632|STANDARD_DEVIATION|2.749|||TWO_SIDED|90.0|-5.152|3.889||||||Change at Day 21: Retardation||3.889|-5.152|
71804806|NCT00148343|143109390|SUPERIORITY||Slope|-5.07|STANDARD_ERROR_OF_MEAN|2.54|<|0.05|TWO_SIDED|95.0|-10.05|-0.09|||Mixed Models Analysis||Slope is in reference to from baseline to end of follow-up at 36 weeks.|||-0.09|-10.05|<0.05
71804807|NCT00148343|143109391|SUPERIORITY_OR_OTHER||Slope|0.31|STANDARD_ERROR_OF_MEAN|7.35|<|0.05|TWO_SIDED|95.0|-14.096|14.716|||Mixed Models Analysis||Slope is in reference to start of treatment to end of follow up at 36 weeks|||14.716|-14.096|<0.05
71804808|NCT00148343|143109392|SUPERIORITY||Slope|-1.95|STANDARD_ERROR_OF_MEAN|5.53|||TWO_SIDED|95.0|-12.79|8.89|||||Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks|||8.89|-12.79|
71804809|NCT00148343|143109393|SUPERIORITY||Slope|0.006|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|-0.045|0.057|||Mixed Models Analysis||Slope is in reference to baseline to end of follow-up at 36 weeks|||0.057|-0.045|<0.05
71804810|NCT04153409|143109394|SUPERIORITY|No formal sample size estimation was undertaken due to the exploratory nature of the study. Statistical comparisons of the 7 mean changes from baseline to different time-points (0-24 hours) were undertaken in one mixed effects model of analysis taking into account the cross-over nature of the study and the multiple time points within each period to explore a possible treatment effect in this small proof of concept study. Change from baseline at 0.5 hours is presented in this section|Mean Difference (Net)|-0.02||||0.9733|TWO_SIDED|95.0|-1.23|1.19||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 0.5 hours||1.19|-1.23|0.9733
71804811|NCT04153409|143109394|SUPERIORITY||Mean Difference (Net)|-0.42||||0.4942|TWO_SIDED|95.0|-1.64|0.79||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1 hour. The change from baseline at 1 hour was extracted from the mixed model analysis including all time points.||0.79|-1.64|0.4942
71804812|NCT04153409|143109394|SUPERIORITY||Mean Difference (Net)|-0.25||||0.6866|TWO_SIDED|95.0|-1.46|0.97||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 1.5 hours. The change from baseline at 1.5 hours was extracted from the mixed model analysis including all time points.||0.97|-1.46|0.6866
71804813|NCT04153409|143109394|SUPERIORITY||Mean Difference (Net)|-0.89||||0.1488|TWO_SIDED|95.0|-2.11|0.32||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 2 hours. The change from baseline at 2 hours was extracted from the mixed model analysis including all time points.||0.32|-2.11|0.1488
71804814|NCT04153409|143109394|SUPERIORITY||Mean Difference (Net)|-0.36||||0.5644|TWO_SIDED|95.0|-1.57|0.86||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 4 hours. The change from baseline at 4 hours was extracted from the mixed model analysis including all time points.||0.86|-1.57|0.5644
71804815|NCT04153409|143109394|SUPERIORITY||Mean Difference (Net)|-0.7||||0.2561|TWO_SIDED|95.0|-1.91|0.51||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 8 hours, The change from baseline at 8 hours was extracted from the mixed model analysis including all time points.||0.51|-1.91|0.2561
71804816|NCT04153409|143109394|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9875|TWO_SIDED|95.0|-1.22|1.2||No adjustment for multiple comparisons has been made due to the exploratory nature of the study|Mixed Models Analysis||Difference is Active-Placebo|Change from baseline at 24 hours. The change from baseline at 24 hours was extracted from the mixed model analysis including all time points.||1.20|-1.22|0.9875
71804817|NCT03579459|143109398|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|Geometric Mean ratio (GMR)|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||Confidence intervals (CIs) were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
71804818|NCT03579459|143109398|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.86|1.18|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.18|0.86|
71804819|NCT03579459|143109398|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin A||1.17|0.85|
71804820|NCT03579459|143109398|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.87|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.87|
71804821|NCT03579459|143109398|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.07|||||TWO_SIDED|95.0|0.88|1.31|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.31|0.88|
71804822|NCT03579459|143109398|EQUIVALENCE|Equivalence was established if the 95% confidence interval of GMC ratio was within the interval (0.5, 2).|GMR|1.01|||||TWO_SIDED|95.0|0.83|1.23|||||CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations|Toxin B||1.23|0.83|
71804823|NCT01592435|143109411|SUPERIORITY_OR_OTHER|||||||0.02||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.02
71804824|NCT01592435|143109412|SUPERIORITY_OR_OTHER|||||||0||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided|||||||0.00
71804825|NCT02528214|143109434|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Least Square (LS) Mean Difference|28.24|||<|0.0001|TWO_SIDED|95.0|15.81|40.67||Threshold for significance at two-sided 0.05 level.|ANCOVA||LS mean difference represents reduction difference i.e. dupilumab - placebo.|The outcome measure was analyzed using analysis of covariance (ANCOVA) model which included percentage reduction of OCS dose at Week 24 as the response variable, and treatment group, baseline eosinophil level, optimized OCS dose at baseline, region as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||40.67|15.81|< 0.0001
71804826|NCT02528214|143109436|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|3.98|||<|0.0001|TWO_SIDED|95.0|2.06|7.67||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved the 50% OCS dose reduction criterion as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||7.67|2.06|< 0.0001
71804827|NCT02528214|143109437|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|4.48|||<|0.0001|TWO_SIDED|95.0|2.39|8.39||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved a reduction of OCS dose to \<5 mg/day at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||8.39|2.39|< 0.0001
71804828|NCT02528214|143109438|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.57||||0.0024|TWO_SIDED|95.0|1.4|4.73||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome was analyzed using a logistic regression model. The model included binary status of whether or not a participant achieved their maximum possible reduction of OCS dose per protocol at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.||4.73|1.4|0.0024
71675447|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.572|||TWO_SIDED|90.0|-1.11|0.771||||||Change at Day 21: Said he/she was no good||0.771|-1.110|
71841764|NCT04089059|143193704|OTHER|Test of difference in distribution of NYHA class from baseline (all patients were class III at baseline).|||||<|0.0001|||||||Chi-squared|||The New York Heart Association (NYHA) Classification is a system used to evaluate and classify the severity of heart failure based on symptoms, patient's physical activity, and quality of life. Its scale ranges from class 1 to 4 with class 1 indicating the least severe heart failure symptoms (i.e., the best functionality) and class 4 indicating the most severe heart failure symptoms (i.e., the poorest functionality), with higher classes indicating poorer functioning as relates to heart failure.||||<0.0001
71841765|NCT04089059|143193705|SUPERIORITY|Comparison of baseline 6MWT vs 6 month 6MWT.||||||0.1086|||||||Wilcoxon (Mann-Whitney)|||||||0.1086
71675448|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.561|STANDARD_DEVIATION|2.63|||TWO_SIDED|90.0|-4.887|3.764||||||Change at Day 21: Social competence||3.764|-4.887|
71804829|NCT02528214|143109439|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.74||||0.0015|TWO_SIDED|95.0|1.47|5.1||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant no longer required OCS at Week 24 as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.||5.1|1.47|0.0015
71804830|NCT00941603|143109462|SUPERIORITY_OR_OTHER||Difference in percent|-3.5||||0.06|TWO_SIDED|95.0|-7.2|0.2|||ANOVA|Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.2|-7.2|0.06
71804831|NCT00941603|143109462|SUPERIORITY_OR_OTHER||Difference in percent|-3.1||||0.1|TWO_SIDED|95.0|-6.7|0.6||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|ANOVA|||||0.6|-6.7|0.10
71804832|NCT00941603|143109462|SUPERIORITY_OR_OTHER||Difference in percent|-5.7|||<|0.01|TWO_SIDED|95.0|-9.4|-2.0|||ANOVA|||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||-2.0|-9.4|<0.01
71804833|NCT00941603|143109462|SUPERIORITY_OR_OTHER||Difference in percent|-1.3||||0.48|TWO_SIDED|95.0|-5.0|2.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.4|-5.0|0.48
71841766|NCT04089059|143193708|SUPERIORITY|Compare NTproBNP at baseline with 6 months||||||0.0628|||||||Wilcoxon (Mann-Whitney)|||||||0.0628
71841767|NCT03728608|143193731|SUPERIORITY|||||||0.92|||||||survival analysis|||||||0.92
71841768|NCT03728608|143193732|SUPERIORITY|||||||0.65|||||||survival analysis|||||||0.65
71841769|NCT03728608|143193733|SUPERIORITY|||||||0.96|||||||survival analysis|||||||0.96
71841770|NCT03728608|143193734|SUPERIORITY|||||||0.77|||||||survival analysis|||||||0.77
71841771|NCT03728608|143193735|SUPERIORITY|||||||0.43|||||||Regression, Logistic|||||||0.43
71841772|NCT03728608|143193736|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
71841773|NCT03728608|143193737|SUPERIORITY|||||||0.97|||||||Regression, Logistic|||||||0.97
71841774|NCT03728608|143193738|SUPERIORITY|||||||0.79|||||||Regression, Logistic|||||||0.79
71841775|NCT01828112|143193779|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.36|0.67|||Log Rank|||||0.67|0.36|<0.001
71841776|NCT05586490|143193843|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.6375||||0.429|TWO_SIDED|||||A priori threshold for statistical significance is p \< 0.05.|t-test, 2 sided|Paired samples t-test, df = 7||||||0.429
71675449|NCT00570063|142868311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62|STANDARD_DEVIATION|4.447|||TWO_SIDED|90.0|-7.934|6.694||||||Change at Day 21: Social interest||6.694|-7.934|
71804834|NCT00941603|143109462|SUPERIORITY_OR_OTHER||Difference in percent|-0.4||||0.85|TWO_SIDED|95.0|-4.0|3.3|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||3.3|-4.0|0.85
71804835|NCT00941603|143109463|SUPERIORITY_OR_OTHER||Difference in percent|-3.0||||0.09|TWO_SIDED|95.0|-6.5|0.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||0.4|-6.5|0.09
71804836|NCT00941603|143109463|SUPERIORITY_OR_OTHER||Difference in percent|-3.6||||0.04|TWO_SIDED|95.0|-7.1|-0.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-0.2|-7.1|0.04
71804837|NCT00941603|143109463|SUPERIORITY_OR_OTHER||Difference in percent|-4.4||||0.01|TWO_SIDED|95.0|-7.9|-1.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||-1.0|-7.9|0.01
71841777|NCT05586490|143193844|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|3.75||||0.351|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.351
71841778|NCT05586490|143193845|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-0.013||||0.937|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.937
71841779|NCT05586490|143193846|OTHER|A comparison is not being made between two different treatment groups.|Mean Difference (Net)|-14.8||||0.044|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|t-test, 2 sided|Paired samples t-test, df = 7||||||0.044
71841780|NCT05586490|143193847|SUPERIORITY||Mean Difference (Net)|-0.68||||0.42|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.42
71841781|NCT05586490|143193847|SUPERIORITY||Mean Difference (Net)|0.57||||0.5|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device group and no device group) controlling for pre-trial measurements, gender, and age.||||||0.50
71841782|NCT05586490|143193848|SUPERIORITY||Mean Difference (Net)|-0.03||||0.986|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.986
71841783|NCT05586490|143193848|SUPERIORITY||Mean Difference (Net)|-1.25||||0.479|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.479
71841784|NCT05586490|143193849|SUPERIORITY||Mean Difference (Net)|-0.195||||0.098|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.098
71804838|NCT00941603|143109463|SUPERIORITY_OR_OTHER||Difference in percent|-1.4||||0.41|TWO_SIDED|95.0|-4.9|2.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||2.0|-4.9|0.41
71804839|NCT00941603|143109463|SUPERIORITY_OR_OTHER||Difference in percent|0.7||||0.68|TWO_SIDED|95.0|-2.7|4.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.||||4.2|-2.7|0.68
71804840|NCT02079805|143109464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||||TWO_SIDED|95.0|-0.89|1.78||||||Telmisartan 40 mg, Azilsartan 20 mg||1.78|-0.89|
71804841|NCT02347761|143109479|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mea Difference (SE)|0.1036|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0663|0.1409||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|MMixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint|standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1409|0.0663|<0.0001
71804842|NCT02347761|143109479|SUPERIORITY|A sample size of 215 subjects per treatment would give \~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mean Difference (SE)|0.0961|STANDARD_ERROR_OF_MEAN|0.01896|<|0.0001|TWO_SIDED|95.0|0.0589|0.1334||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|Mixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.|Standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1334|0.0589|<0.0001
71804843|NCT02347761|143109480|SUPERIORITY||Least Squares Mean (SE)|0.1264|STANDARD_ERROR_OF_MEAN|0.02076|<|0.0001|TWO_SIDED|95.0|0.0856|0.1672||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least squares mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1672|0.0856|<0.0001
71804844|NCT02347761|143109480|SUPERIORITY|In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|LS mean (SE)|0.1052|STANDARD_ERROR_OF_MEAN|0.0206|<|0.0001|TWO_SIDED|95.0|0.0647|0.1457|||LS mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.||0.1457|0.0647|<0.0001
71804845|NCT01040130|143109549|SUPERIORITY_OR_OTHER||Ratio to placebo|1.14|STANDARD_ERROR_OF_MEAN|0.04||0.0002||95.0|1.065|1.221|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo|||1.221|1.065|0.0002
71804846|NCT01040130|143109549|SUPERIORITY_OR_OTHER||Ratio to placebo|1.138|STANDARD_ERROR_OF_MEAN|0.04||0.0003||95.0|1.062|1.219|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo|||1.219|1.062|0.0003
71841785|NCT05586490|143193849|SUPERIORITY||Mean Difference (Net)|-0.039||||0.729|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.729
71841786|NCT05586490|143193850|SUPERIORITY||Mean Difference (Net)|-8.15||||0.058|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.0580
71841787|NCT05586490|143193850|SUPERIORITY||Mean Difference (Net)|-1.54||||0.718|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.718
71841788|NCT05586490|143193852|SUPERIORITY||Mean Difference (Net)|0.063||||0.816|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.816
71841789|NCT05586490|143193852|SUPERIORITY||Mean Difference (Net)|-0.0048||||0.985|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.985
71841790|NCT05586490|143193853|SUPERIORITY||Mean Difference (Net)|6.33||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (alternate device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.59
71841791|NCT05586490|143193853|SUPERIORITY||Mean Difference (Net)|8.16||||0.51|TWO_SIDED|||||A priori threshold for statistical significance was p \< 0.05|ANCOVA|Estimated difference between groups (research device and no device group) controlling for pre-trial measurements, gender, and age.||||||0.51
71804847|NCT01040130|143109550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.112|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.112|<0.0001
71804848|NCT01040130|143109550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.104|0.245|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.245|0.104|<0.0001
71804849|NCT01040130|143109551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.766|STANDARD_ERROR_OF_MEAN|0.223||0.0007||95.0|-1.205|-0.326|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.326|-1.205|0.0007
71804850|NCT01040130|143109551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.634|STANDARD_ERROR_OF_MEAN|0.225||0.0051||95.0|-1.077|-0.192|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.192|-1.077|0.0051
71804851|NCT01040130|143109552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.258|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.191|0.325|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.325|0.191|<0.0001
71804852|NCT01040130|143109552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.226|0.362|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.362|0.226|<0.0001
71804853|NCT01040130|143109553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.107|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.252|0.107|<0.0001
71804854|NCT01040130|143109553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.037||0.0003||95.0|0.064|0.21|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.210|0.064|0.0003
71804855|NCT01040130|143109554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.051||0.0447||95.0|-0.204|-0.002|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.002|-0.204|0.0447
71804856|NCT01040130|143109554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.064|STANDARD_ERROR_OF_MEAN|0.052||0.2132||95.0|-0.166|0.037|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.037|-0.166|0.2132
71804857|NCT01040130|143109555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.154||0.5698||95.0|-0.391|0.216|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.216|-0.391|0.5698
71804858|NCT01040130|143109555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.155||0.1003||95.0|-0.05|0.561|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.561|-0.050|0.1003
71804859|NCT01040130|143109556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.122|STANDARD_ERROR_OF_MEAN|0.069||0.0784||95.0|-0.258|0.014|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.014|-0.258|0.0784
71804860|NCT01040130|143109556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.07||0.1013||95.0|-0.252|0.023|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.023|-0.252|0.1013
71804861|NCT01040130|143109557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.066||0.0015||95.0|-0.339|-0.081|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||-0.081|-0.339|0.0015
71804862|NCT01040130|143109557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001||95.0|-0.503|-0.243|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.243|-0.503|<0.0001
71804863|NCT01040130|143109558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.034||0.0005||95.0|0.052|0.185|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.185|0.052|0.0005
71804864|NCT01040130|143109558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0073||95.0|0.025|0.159|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.159|0.025|0.0073
71804865|NCT01040130|143109559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.136|0.275|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.275|0.136|<0.0001
71804866|NCT01040130|143109559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.146|0.285|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.285|0.146|<0.0001
71804867|NCT01040130|143109560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.062||0.9239||95.0|-0.115|0.127|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.127|-0.115|0.9239
71841792|NCT05290493|143193888|SUPERIORITY|||||||0.0672|||||||Mixed Models Analysis|||||||0.0672
71804868|NCT01040130|143109560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.062||0.7368||95.0|-0.144|0.102|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.102|-0.144|0.7368
71841793|NCT05290493|143193889|SUPERIORITY|||||||0.2045|||||||Mixed Models Analysis|||||||0.2045
71841794|NCT05290493|143193890|SUPERIORITY|||||||0.2931|||||||Mixed Models Analysis|||||||0.2931
71841795|NCT05290493|143193891|SUPERIORITY|||||||0.7799|||||||Mixed Models Analysis|||||||0.7799
71804869|NCT01040130|143109561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.067||0.8302||95.0|-0.146|0.118|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.118|-0.146|0.8302
71804870|NCT01040130|143109561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.068||0.0202||95.0|-0.292|-0.025|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||-0.025|-0.292|0.0202
71804871|NCT01040130|143109562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.056|0.123|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.123|0.056|<0.0001
71804872|NCT01040130|143109562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.068|0.134|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.134|0.068|<0.0001
71804873|NCT01040130|143109563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.191|0.258|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.258|0.191|<0.0001
71804874|NCT01040130|143109563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.193|0.259|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.259|0.193|<0.0001
71804875|NCT01040130|143109564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.031||0.0006||95.0|0.046|0.167|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.167|0.046|0.0006
71804876|NCT01040130|143109564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.031||0.0017||95.0|0.037|0.158|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.158|0.037|0.0017
71841796|NCT05290493|143193892|SUPERIORITY|||||||0.7974|||||||Mixed Models Analysis|||||||0.7974
71804877|NCT01040130|143109565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.285|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.227|0.342|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.342|0.227|<0.0001
71804878|NCT01040130|143109565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.233|0.348|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.348|0.233|<0.0001
71804879|NCT01040130|143109566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.207|0.429|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.429|0.207|<0.0001
71804880|NCT01040130|143109566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|0.192|0.414|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.414|0.192|<0.0001
71841797|NCT05290493|143193893|SUPERIORITY|||||||0.8286|||||||Mixed Models Analysis|||||||0.8286
71804881|NCT01040130|143109567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.585|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001||95.0|0.47|0.701|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo|||0.701|0.470|<0.0001
71804882|NCT01040130|143109567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.618|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001||95.0|0.502|0.734|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo|||0.734|0.502|<0.0001
71841798|NCT05419830|143193895|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep time dip in systolic BP. Analysis was adjusted for baseline value of the outcome||||||0.65|||||||ANCOVA|||||||0.65
71841799|NCT05419830|143193896|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in nocturia frequency. Analysis was adjusted for baseline value of the outcome||||||0.66|||||||ANCOVA|||||||0.66
71841800|NCT05419830|143193897|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in NPi. Analysis was adjusted for baseline value of the outcome||||||0.14|||||||ANCOVA|||||||0.14
71841801|NCT05419830|143193898|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in PSQI scores. Analysis was adjusted for baseline value of the outcome||||||0.2|||||||ANCOVA|||||||0.2
71841802|NCT05419830|143193899|OTHER|Three-group ANCOVA comparisons were completed using pre- to post-intervention changes in sleep efficiency. Analysis was adjusted for baseline value of the outcome||||||0.02|||||||ANCOVA|||||||0.02
71841803|NCT03677141|143193900|SUPERIORITY||Difference in rates|-4.77|||||TWO_SIDED|95.0|-30.61|21.07||||||||21.07|-30.61|
71841804|NCT05280574|143193936|OTHER||Ratio of geometric means|0.75|||<|0.05|TWO_SIDED|95.0|0.51|1.1|||Distinct-effects GEE model||Average relative effect of unblinded versus blinded monitoring across the 5-component composite (SpO2 \<85%, RR \>30/min, RR \<4/min, HR \<45/min, HR \>130/min) of cumulative durations.||We assessed the treatment effect of unblinded versus blinded monitoring across the 5-component primary outcome composite of cumulative durations by estimating the average relative effect on the log-transformed count data (counts of observations beyond a given threshold at 1 Hz). Specifically, we employed a distinct-effects (i.e., separate treatment effect estimated for each component) generalized estimating equation (GEE) model to account for within-subject correlation across components with the vector of the 5 cumulative durations as the dependent variable and treatment as independent. We then averaged the component-specific effects and tested whether the average effect equals zero (on the log scale), and reported results as the ratio of geometric means of unblinded versus blinded monitoring.|1.1|0.51|< 0.05
71894312|NCT01416181|143310663|SUPERIORITY_OR_OTHER|||||||0.0585|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||CP Group: Week 156||||0.0585
71675450|NCT00570063|142868312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.712|STANDARD_DEVIATION|12.24|||TWO_SIDED|90.0|-14.42|25.845||||||||25.845|-14.42|
71675451|NCT00570063|142868322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.849|STANDARD_DEVIATION|4.23|||TWO_SIDED|90.0|-7.807|6.109||||||||6.109|-7.807|
71894313|NCT01416181|143310663|SUPERIORITY_OR_OTHER|||||||0.6095|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (dominant hand).||NP Group: Week 156||||0.6095
71675452|NCT00570063|142868323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.195|STANDARD_DEVIATION|9.307|||TWO_SIDED|90.0|-19.5|11.114||||||||11.114|-19.50|
71675453|NCT00570063|142868324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.273|STANDARD_DEVIATION|3.488|||TWO_SIDED|90.0|-6.01|5.465||||||Change at Day 21: Parkinsonism||5.465|-6.010|
71841805|NCT03505008|143194027|NON_INFERIORITY|Two-sided 90% CI for the intergroup difference in SDAI remission rates to exceed the non-inferiority margin of -15%|Risk Difference (RD)|0.0|||||TWO_SIDED|90.0||||||||||||
71894314|NCT01416181|143310664|SUPERIORITY_OR_OTHER|||||||0.723|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.7230
71675454|NCT00570063|142868324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.182|STANDARD_DEVIATION|3.008|||TWO_SIDED|90.0|-5.13|4.766||||||Change at Day 21: Dyskinesia||4.766|-5.130|
71841806|NCT04820322|143194069|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
71841807|NCT04820322|143194070|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
71841808|NCT04820322|143194071|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71841809|NCT04820322|143194072|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
71675455|NCT00570063|142868324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.932|STANDARD_DEVIATION|1.425|||TWO_SIDED|90.0|-3.275|1.411||||||Change at Day 21: Dystonia||1.411|-3.275|
71675456|NCT00570063|142868324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.705|STANDARD_DEVIATION|1.652|||TWO_SIDED|90.0|-2.013|3.422||||||Change at Day 21: Akathisia||3.422|-2.013|
71675457|NCT00570063|142868325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.291|STANDARD_DEVIATION|1.203|||TWO_SIDED|90.0|-2.27|1.688||||||Change at Day 4||1.688|-2.270|
71675458|NCT00570063|142868325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.327|STANDARD_DEVIATION|1.349|||TWO_SIDED|90.0|-1.892|2.547||||||Change at Day 7||2.547|-1.892|
71675459|NCT00570063|142868325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.436|STANDARD_DEVIATION|1.448|||TWO_SIDED|90.0|-1.946|2.817||||||Change at Day 14||2.817|-1.946|
71675460|NCT00570063|142868325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.133|||TWO_SIDED|90.0|-1.763|1.963||||||Change at Day 21||1.963|-1.763|
71841810|NCT04820322|143194073|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
71841811|NCT04820322|143194074|SUPERIORITY|||||||0.71|||||||Fisher Exact|||||||0.71
71841812|NCT04820322|143194075|SUPERIORITY|||||||0.67|||||||Fisher Exact|||||||0.67
71841813|NCT04820322|143194076|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71841814|NCT04820322|143194077|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||||||0.023
71841815|NCT04820322|143194078|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71841816|NCT04820322|143194079|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
71841817|NCT02998528|143194100|SUPERIORITY||Cox Proportional Hazard|0.63||||0.0052|TWO_SIDED|97.38|0.43|0.91|||Log Rank|Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)||||0.91|0.43|0.0052
71894315|NCT01416181|143310664|SUPERIORITY_OR_OTHER|||||||0.8781|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.8781
71894316|NCT01416181|143310664|SUPERIORITY_OR_OTHER|||||||0.2751|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.2751
71894317|NCT01416181|143310665|SUPERIORITY_OR_OTHER|||||||0.5051|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||Overall: Week 156||||0.5051
71894318|NCT01416181|143310665|SUPERIORITY_OR_OTHER|||||||0.7283|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||CP Group: Week 156||||0.7283
71675461|NCT03307252|142868330|OTHER||Adjusted geometric mean (gMean) ratio|100.7|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|88.84|114.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|114.15|88.84|
71675462|NCT03307252|142868330|OTHER||Adjusted gMean ratio|93.76|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|86.12|102.06|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|102.06|86.12|
71804883|NCT00780962|143109631|SUPERIORITY||Percentage Difference|0.6|||>|0.5|TWO_SIDED|95.0|-4.8|6.0|||Wald|||"The study was powered to find a 10% absolute risk reduction in the rate of contrast-induced nephropathy (a=.05, 90% power). We initially estimated the need for 600 patients and repowered to 800 patients after the 1st interim analysis. The study was halted for futility at the 2nd interim analysis.~Reported here 357 (89.4%) of the 399 enrolled subjects who completed a second blood draw at the time the study closed."||6.0|-4.8|>0.5
71804884|NCT01812044|143109654|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.035
71804885|NCT01812044|143109654|SUPERIORITY_OR_OTHER|||||||0.189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.189
71804886|NCT01812044|143109654|SUPERIORITY_OR_OTHER|||||||0.298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.||||||0.298
71813546|NCT00803101|143129463|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|14.3|||||TWO_SIDED|95.0|2.8|25.8||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|95% confidence interval|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % participants with effective hemostasis||The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||25.8|2.8|
71813547|NCT00803101|143129464|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|45.3|||||TWO_SIDED|95.0|31.9|56.4||No P-value is provided as non-inferiority was assessed via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|Newcombe-Wilson score method|The Newcombe-Wilson score method was used to estimate the 95% CI for the difference (Beriplex-plasma) in the % pts with rapid decrease of the INR.||The analysis of rapid decrease of the INR was via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with INR ≤ 1.3 at 30 minutes after the end of infusion.||56.4|31.9|
71813548|NCT04858802|143129472|SUPERIORITY||Mean Difference (Net)|4.19|STANDARD_DEVIATION|19.08||0.059|TWO_SIDED|95.0|-0.2|8.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|The null hypothesis was that there would no difference in FSO cross-sectional area between treatment and control sides at Day 45.||8.6|-0.2|0.059
71813549|NCT04858802|143129473|SUPERIORITY||Mean Difference (Final Values)|1.48|STANDARD_DEVIATION|12.98||0.328|TWO_SIDED|95.0|-1.5|4.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||4.5|-1.5|0.328
71894319|NCT01416181|143310665|SUPERIORITY_OR_OTHER|||||||0.1666|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 9HPT (non-dominant hand).||NP Group: Week 156||||0.1666
71894320|NCT01416181|143310666|SUPERIORITY_OR_OTHER|||||||0.433|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.4330
71894321|NCT01416181|143310666|SUPERIORITY_OR_OTHER|||||||0.7122|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.7122
71675463|NCT03307252|142868330|OTHER||Adjusted gMean Ratio|82.97|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|76.96|89.46|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|89.46|76.96|
71675464|NCT03307252|142868330|OTHER||Adjusted gMean Ratio|113.4|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|97.62|131.72|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|131.72|97.62|
71675465|NCT03307252|142868331|OTHER||Adjusted geometric mean (gMean) ratio|131.41|STANDARD_ERROR_OF_MEAN|17.9|||TWO_SIDED|90.0|115.93|148.97|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|148.97|115.93|
71675466|NCT03307252|142868331|OTHER||Adjusted gMean ratio|119.78|STANDARD_ERROR_OF_MEAN|12.1|||TWO_SIDED|90.0|110.03|130.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.39|110.03|
71804887|NCT05349617|143109701|SUPERIORITY||Percent Difference|86.2|||<|0.0001|TWO_SIDED|95.0|80.0|90.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||90.3|80|<0.0001
71804888|NCT05349617|143109702|SUPERIORITY||[GMT Ratio]|90.0|||<|0.0001|TWO_SIDED|95.0|69.0|117.0||Both coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo).|Day 22||117|69|<0.0001
71804889|NCT05349617|143109708|SUPERIORITY||Percent Difference|79.5|||<|0.0001|TWO_SIDED|95.0|72.3|84.6||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||84.6|72.3|<0.0001
71804890|NCT05349617|143109708|SUPERIORITY||Percent Difference|74.4|||<|0.0001|TWO_SIDED|95.0|67.1|80.1||Key secondary endpoints were tested hierarchically (Day 15 tested prior to Day 183), such that each was only tested if both coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||80.1|67.1|<0.0001
71894322|NCT01416181|143310666|SUPERIORITY_OR_OTHER|||||||0.3861|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.3861
71675467|NCT03307252|142868331|OTHER||Adjusted gMean Ratio|108.55|STANDARD_ERROR_OF_MEAN|10.7|||TWO_SIDED|90.0|100.68|117.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.03|100.68|
71675468|NCT03307252|142868331|OTHER||Adjusted gMean Ratio|348.06|STANDARD_ERROR_OF_MEAN|21.5|||TWO_SIDED|90.0|299.64|404.31|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|404.31|299.64|
71804891|NCT05349617|143109709|SUPERIORITY||[GMT Ratio]|42.0|||<|0.0001|TWO_SIDED|95.0|32.0|56.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 15||56|32|<0.0001
71804892|NCT05349617|143109709|SUPERIORITY||[GMT Ratio]|28.0|||<|0.0001|TWO_SIDED|95.0|22.0|35.0|||ANOVA|ANOVA model covers site and treatment group as fixed effects, assuming log titers' normality. p-value tests equivalence of mean titers between groups.|Ratio of GMTs is (PXVX0317:placebo)|Day 183||35|22|<0.0001
71804893|NCT05349617|143109710|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
71804894|NCT05349617|143109710|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
71894323|NCT01416181|143310667|SUPERIORITY_OR_OTHER|||||||0.7225|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156||||0.7225
71894324|NCT01416181|143310667|SUPERIORITY_OR_OTHER|||||||0.9121|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156||||0.9121
71894325|NCT01416181|143310667|SUPERIORITY_OR_OTHER|||||||0.2594|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156||||0.2594
71675469|NCT03307252|142868332|OTHER||Adjusted geometric mean (gMean) ratio|125.61|STANDARD_ERROR_OF_MEAN|13.2|||TWO_SIDED|90.0|113.99|138.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|138.43|113.99|
71675470|NCT03307252|142868332|OTHER||Adjusted gMean ratio|101.21|STANDARD_ERROR_OF_MEAN|9.2|||TWO_SIDED|90.0|94.59|108.3|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.30|94.59|
71675471|NCT03307252|142868332|OTHER||Adjusted gMean Ratio|130.94|STANDARD_ERROR_OF_MEAN|13.6|||TWO_SIDED|90.0|119.82|143.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.10|119.82|
71675472|NCT03307252|142868332|OTHER||Adjusted gMean Ratio|107.42|STANDARD_ERROR_OF_MEAN|12.9|||TWO_SIDED|90.0|97.57|118.27|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.27|97.57|
71804895|NCT05349617|143109710|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95 percent CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
71804896|NCT05349617|143109711|SUPERIORITY||Percent Difference|91.6|||<|0.0001|TWO_SIDED|95.0|86.0|94.6|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||94.6|86.0|<0.0001
71804897|NCT05349617|143109711|SUPERIORITY||Percent Difference|94.1|||<|0.0001|TWO_SIDED|95.0|89.2|96.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||96.5|89.2|<0.0001
71804898|NCT05349617|143109711|SUPERIORITY||Percent Difference|91.8|||<|0.0001|TWO_SIDED|95.0|86.3|94.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||94.8|86.3|<0.0001
71894326|NCT01416181|143310668|SUPERIORITY_OR_OTHER|||||||0.8066|||||||ANCOVA|p-value for comparison between active \& placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL 6MWT.||Week 156||||0.8066
71675473|NCT03307252|142868333|OTHER||Adjusted geometric mean (gMean) ratio|106.78|STANDARD_ERROR_OF_MEAN|15.5|||TWO_SIDED|90.0|96.51|118.15|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|118.15|96.51|
71675474|NCT03307252|142868333|OTHER||Adjusted gMean ratio|271.63|STANDARD_ERROR_OF_MEAN|15.9|||TWO_SIDED|90.0|246.74|299.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|299.03|246.74|
71675475|NCT03307252|142868333|OTHER||Adjusted gMean Ratio|100.8|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|90.0|94.62|107.39|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.39|94.62|
71804899|NCT05349617|143109711|SUPERIORITY||Percent Difference|82.8|||<|0.0001|TWO_SIDED|95.0|75.9|87.5||p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|Chi-squared||SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||87.5|75.9|<0.0001
71804900|NCT05349617|143109711|SUPERIORITY||Percent Difference|88.3|||<|0.0001|TWO_SIDED|95.0|82.4|92.0|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||92.0|82.4|<0.0001
71894327|NCT01416181|143310670|SUPERIORITY_OR_OTHER|||||||0.7084|||||||ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL MSIS-29 physical score.||||||0.7084
71894328|NCT01416181|143310672|SUPERIORITY_OR_OTHER|||||||0.3465|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (\<=5.5 or\>=6) and BL SDMT.||Week 156||||0.3465
71804901|NCT05349617|143109711|SUPERIORITY||Percent Difference|82.0|||<|0.0001|TWO_SIDED|95.0|75.2|86.8|||Chi-squared|p-value is from a two-sided chi-square test of equality of SNA response percentages between groups.|SNA response rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||86.8|75.2|<0.0001
71804902|NCT00746954|143109712|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANOVA|||Comparisons among groups||||0.45
71675476|NCT03307252|142868333|OTHER||Adjusted gMean Ratio|223.24|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|203.79|244.55|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|244.55|203.79|
71675477|NCT03307252|142868334|OTHER||Adjusted geometric mean (gMean) ratio|121.64|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|100.43|147.33|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|147.33|100.43|
71675478|NCT03307252|142868334|OTHER||Adjusted gMean ratio|95.18|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|83.03|109.11|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.11|83.03|
71804903|NCT00492349|143109719|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
71804904|NCT00492349|143109720|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||All treatment main and interaction effect p-values were \> 0.05.|ANCOVA|||Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||>0.05
71804905|NCT00492349|143109721|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.||||<0.05
71804906|NCT01153633|143109751|SUPERIORITY_OR_OTHER|||||||0.2317||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.2317
71804907|NCT01153633|143109755|SUPERIORITY_OR_OTHER|||||||0.4905||95.0|||||Fisher Exact|||||||0.4905
71804908|NCT01153633|143109756|SUPERIORITY_OR_OTHER|||||||0.9945||95.0||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test|||||||0.9945
71804909|NCT00384085|143109757|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.56||||0.0628|TWO_SIDED|95.0|0.97|2.52||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.52|0.97|0.0628
71804910|NCT00384085|143109758|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of Lantus/Apidra-1 would be established if the upper limit of the 2 sided, 99.75% CI for the difference in the mean change from baseline between Lantus/Apidra-1 and Novolog Mix 70/30 was \<0.5%.|Adjusted Mean of difference|-0.34||||0.0359|TWO_SIDED|95.0|-0.82|0.15||The type I error was controlled by performing a 2-tailed comparison at a p=0.0025 level for noninferiority testing.|Mixed Models Analysis|||||0.15|-0.82|0.0359
71804911|NCT00384085|143109759|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.66||||0.0313|TWO_SIDED|95.0|1.04|2.64||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic|||||2.64|1.04|0.0313
71804912|NCT00384085|143109760|SUPERIORITY_OR_OTHER||Adjusted Mean of difference|-0.31||||0.0565|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||||0.01|-0.63|0.0565
71804913|NCT00384085|143109761|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.79||||0.014|TWO_SIDED|95.0|1.12|2.85|||Regression, Logistic|||||2.85|1.12|0.0140
71804914|NCT00384085|143109762|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.02||||0.9268|TWO_SIDED|95.0|0.61|1.71|||Regression, Logistic|||||1.71|0.61|0.9268
71804915|NCT00384085|143109762|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.11||||0.0107|TWO_SIDED|95.0|1.19|3.73|||Regression, Logistic|||||3.73|1.19|0.0107
71841818|NCT02998528|143194101|SUPERIORITY||% Difference|21.6|||||TWO_SIDED|99.0|13.0|30.3|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||30.3|13.0|
71841819|NCT02998528|143194101|SUPERIORITY||Odds Ratio (OR)|13.94|||<|0.0001|TWO_SIDED|99.0|3.49|55.75|||Cochran-Mantel-Haenszel||Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||55.75|3.49|<0.0001
71804916|NCT00384085|143109762|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.06||||0.0121|TWO_SIDED|95.0|1.17|3.61|||Regression, Logistic|||||3.61|1.17|0.0121
71804917|NCT00071487|143109765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.3677|TWO_SIDED|95.0|-19.4|7.2||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.2|-19.4|0.3677
71841820|NCT02998528|143194102|SUPERIORITY||% Difference|27.9|||||TWO_SIDED|95.0|19.6|36.1|||||Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||36.1|19.6|
71804918|NCT00071487|143109765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.4244|TWO_SIDED|95.0|-8.7|20.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||20.6|-8.7|0.4244
71804919|NCT00071487|143109765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.3296|TWO_SIDED|95.0|-19.6|6.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||6.6|-19.6|0.3296
71841821|NCT02998528|143194102|SUPERIORITY||Odds Ratio (OR)|5.7|||||TWO_SIDED|95.0|3.16|10.26|||||Stratified by PD-L1 (≥ 1% vs \<1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||10.26|3.16|
71675479|NCT03307252|142868334|OTHER||Adjusted gMean Ratio|80.19|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|73.01|88.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|88.08|73.01|
71804920|NCT00071487|143109766|SUPERIORITY_OR_OTHER|||||||0.6423||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.6423
71675480|NCT03307252|142868334|OTHER||Adjusted gMean Ratio|115.39|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|93.8|141.94|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|141.94|93.80|
71804921|NCT00071487|143109766|SUPERIORITY_OR_OTHER|||||||0.8536||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.8536
71804922|NCT00071487|143109766|SUPERIORITY_OR_OTHER|||||||0.9705||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.||||0.9705
71804923|NCT00071487|143109767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.1||||0.1763|TWO_SIDED|95.0|-22.4|4.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||4.1|-22.4|0.1763
71804924|NCT00071487|143109767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.7112|TWO_SIDED|95.0|-20.9|14.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||14.3|-20.9|0.7112
71804925|NCT00071487|143109767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.332|TWO_SIDED|95.0|-22.2|7.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||7.5|-22.2|0.3320
71804926|NCT00071487|143109768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.6||||0.1287|TWO_SIDED|95.0|-65.6|8.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.||8.4|-65.6|0.1287
71841822|NCT02998528|143194104|SUPERIORITY||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.36|0.77|||||Stratified by: PD-L1 status (≥ 1% vs \<1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)|||0.77|0.36|
71841823|NCT06029452|143194105|NON_INFERIORITY|Non-inferiority margin was 0.10.|Sensitivity|0.853|||||ONE_SIDED|95.0|0.815||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.815|
71841824|NCT06029452|143194105|NON_INFERIORITY|Non-inferiority margin was 0.10.|Specificity|0.584|||||ONE_SIDED|95.0|0.539||||||Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN).||||0.539|
71841825|NCT04204083|143194106|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71841826|NCT04204083|143194107|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71841827|NCT04204083|143194108|OTHER||||||<|0.0001||||||P-Value was calculated|t-test, 1 sided|||||||<0.0001
71841828|NCT04271046|143194163|OTHER|||||||0.97|||||||Regression, Linear|||||||0.97
71841829|NCT04271046|143194164|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
71841830|NCT04271046|143194165|OTHER|||||||0.26|||||||Regression, Linear|||||||0.26
71841831|NCT04271046|143194166|OTHER|||||||0.42|||||||Regression, Linear|||||||0.42
71841832|NCT04271046|143194173|OTHER|||||||0.08|||||||Regression, Linear|||||||0.08
71841833|NCT04271046|143194174|OTHER|||||||0.79|||||||Regression, Linear|||||||0.79
71841834|NCT04271046|143194175|OTHER|||||||0.6|||||||Regression, Linear|||||||0.60
71841835|NCT04271046|143194176|OTHER|||||||0.86|||||||Regression, Linear|||||||0.86
71841836|NCT04271046|143194177|OTHER|||||||0.46|||||||Regression, Linear|||||||0.46
71841837|NCT04271046|143194178|OTHER|||||||0.55|||||||Regression, Linear|||||||0.55
71841838|NCT04271046|143194179|OTHER|||||||0.63|||||||Regression, Linear|||||||0.63
71841839|NCT04271046|143194180|OTHER|||||||0.28|||||||Regression, Linear|||||||0.28
71841840|NCT04271046|143194181|OTHER|||||||0.82|||||||Regression, Linear|||||||0.82
71841841|NCT04271046|143194182|OTHER|||||||0.04|||||||Regression, Linear|||||||0.04
71841842|NCT04271046|143194183|OTHER|||||||0.98|||||||Regression, Linear|||||||0.98
71841843|NCT04271046|143194184|OTHER|||||||0.22|||||||Regression, Linear|||||||0.22
71841844|NCT04271046|143194185|OTHER|||||||0.85|||||||Regression, Linear|||||||0.85
71841845|NCT04271046|143194186|OTHER|||||||0.8|||||||Regression, Linear|||||||0.80
71894329|NCT01416181|143310676|SUPERIORITY_OR_OTHER|||||||0.007||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL normalized brain volume.||Percentage change from Week 24 to Week 156||||0.0070
71894330|NCT01416181|143310677|SUPERIORITY_OR_OTHER|||||||0.5034||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active \& placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) \& BL WGM brain volume||Percentage hange from Baseline to Week 156||||0.5034
71804927|NCT00071487|143109768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98||||0.8807|TWO_SIDED|95.0|-36.2|42.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||42.1|-36.2|0.8807
71804928|NCT00071487|143109768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.41||||0.1131|TWO_SIDED|95.0|-68.1|7.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.||7.3|-68.1|0.1131
71804929|NCT00071487|143109769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.7823|TWO_SIDED|95.0|-13.8|10.4||P-value was not adjusted for multiple testing|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||10.4|-13.8|0.7823
71804930|NCT00071487|143109769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.1774|TWO_SIDED|95.0|-18.2|3.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||3.4|-18.2|0.1774
71804931|NCT00071487|143109769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.6406|TWO_SIDED|95.0|-14.8|9.1|||t-test, 2 sided|P-value was not adjusted for multiple testing.||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||9.1|-14.8|0.6406
71804932|NCT00071487|143109770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.7822|TWO_SIDED|95.0|-38.6|29.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||29.1|-38.6|0.7822
71804933|NCT00071487|143109770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9||||0.3332|TWO_SIDED|95.0|-45.3|15.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||15.4|-45.3|0.3332
71804934|NCT00071487|143109770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7||||0.466|TWO_SIDED|95.0|-46.9|21.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.||21.5|-46.9|0.4660
71804935|NCT00071487|143109771|SUPERIORITY_OR_OTHER|||||||0.5615||95.0||||P-value was not adjusted for multiple comparisons.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.5615
71804936|NCT00071487|143109771|SUPERIORITY_OR_OTHER|||||||0.7593||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.7593
71804937|NCT00071487|143109771|SUPERIORITY_OR_OTHER|||||||0.2273||95.0||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).||||0.2273
71804938|NCT00071487|143109772|SUPERIORITY_OR_OTHER||percent difference from placebo|-7.1||||0.4355|TWO_SIDED|95.0|-24.7|10.6||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||10.6|-24.7|0.4355
71804939|NCT00071487|143109772|SUPERIORITY_OR_OTHER||percent difference from placebo|4.4||||0.6669|TWO_SIDED|95.0|-15.5|24.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||24.2|-15.5|0.6669
71804940|NCT00071487|143109772|SUPERIORITY_OR_OTHER||percent difference from placebo|17.7||||0.0882|TWO_SIDED|95.0|-2.5|37.9||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.||37.9|-2.5|0.0882
71804941|NCT00987467|143109802|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71804942|NCT02646423|143109813|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.84|1.05||||||||1.05|0.84|
71804943|NCT02646423|143109814|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.86|1.16||||||||1.16|0.86|
71804944|NCT02646423|143109815|SUPERIORITY||Mean Difference (Net)|0.01|||||TWO_SIDED|95.0|-0.16|0.19||||||||0.19|-0.16|
71804945|NCT02646423|143109816|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-1.81|1.05||||||||1.05|-1.81|
71804946|NCT02646423|143109817|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-1.96|1.27||||||||1.27|-1.96|
71804947|NCT02646423|143109818|SUPERIORITY||Mean Difference (Net)|0.36|||||TWO_SIDED|95.0|-0.94|1.66||||||||1.66|-0.94|
71804948|NCT02646423|143109819|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.03||||||||0.03|-0.09|
71804949|NCT02646423|143109820|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.46|1.51||||||||1.51|0.46|
71804950|NCT02646423|143109821|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.64|1.56||||||||1.56|0.64|
71804951|NCT02646423|143109822|SUPERIORITY||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.64|2.81||||||||2.81|0.64|
71804952|NCT02646423|143109823|SUPERIORITY||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.6|6.62||||||||6.62|0.60|
71804953|NCT02646423|143109824|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.72|1.35||||||||1.35|0.72|
71804954|NCT02646423|143109825|SUPERIORITY||Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.86|1.48||||||||1.48|0.86|
71804955|NCT01227889|143109826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.6||The p value from a stratified log-rank test was adjusted for disease stage at screening.|Log Rank||HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.|||0.60|0.26|<0.0001
71841846|NCT04615273|143194215|SUPERIORITY||Estimate of Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-2.94|-1.14|||ANCOVA|||Analysis included treatment arm, region, baseline age group, gender, concomitant oral estrogen, Adult Growth Hormone Deficiency (AGHD) onset as factors \& baseline trunk percent fat as the covariates. Multiple imputation method was used to impute missing data.||-1.14|-2.94|<.0001
71841847|NCT05465239|143194219|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for control subjects.|||||<|0.001|||||||t-test, 1 sided|||||||< 0.001
71841848|NCT05465239|143194219|EQUIVALENCE|Equivalence analysis of metabolic energy consumption using the unpowered vs powered walker for subjects with walking disabilities.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71841849|NCT03673501|143194244|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3598|TWO_SIDED|95.0|0.66|1.16|||Log Rank|Strata: by intolerance to imatinib treatment||||1.16|0.66|0.3598
71841850|NCT03673501|143194245|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7153|TWO_SIDED|95.0|0.82|1.33||Two-sided P-value|Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||1.33|0.82|0.7153
71841851|NCT03673501|143194246|SUPERIORITY|||||||0.0333|||||||Cochran-Mantel-Haenszel|Strata: intolerance to imatinib treatment||||||0.0333
71841852|NCT03673501|143194247|SUPERIORITY|||||||0.2681|||||||Cochran-Mantel-Haenszel|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment||||||0.2681
71841853|NCT03673501|143194248|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7733|TWO_SIDED|95.0|0.75|1.48|||Log Rank|Strata: intolerance to imatinib treatment||||1.48|0.75|0.7733
71841854|NCT03673501|143194249|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3928|TWO_SIDED|95.0|0.66|1.18|||Log Rank|Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib||||1.18|0.66|0.3928
71675481|NCT03307252|142868335|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
71841855|NCT05838027|143194250|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|0.84|12.55||||||||12.55|0.84|
71841856|NCT05838027|143194251|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.24|2.64||||||||2.64|0.24|
71841857|NCT05838027|143194252|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.52|||||TWO_SIDED|95.0|-3.78|4.82||||||||4.82|-3.78|
71841858|NCT05838027|143194253|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.01|1.4||||||||1.40|-1.01|
71841859|NCT05838027|143194254|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-2.71|||||TWO_SIDED|95.0|-7.43|2.0||||||||2.00|-7.43|
71841860|NCT05838027|143194255|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-5.45|4.16||||||||4.16|-5.45|
71841861|NCT05838027|143194256|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|1.12|||||TWO_SIDED|95.0|0.46|2.74||||||||2.74|0.46|
71894331|NCT01416181|143310678|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the active and placebo groups at Week 156 compared to Week 108 is based on negative binomial regression model, adjusted for baseline EDSS (\<=5.5 or \>=6) and baseline volume of T2 lesions.|negative binomial regression model|natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment||Week 156||||< 0.0001
71894332|NCT00698516|143310683|SUPERIORITY_OR_OTHER||Greenwood variance|65.0|STANDARD_ERROR_OF_MEAN|7.07||0.017|TWO_SIDED|95.0|49.3|76.9||Historical data in target population showed 3-month PFS rates of \<=50%. Oral topotecan with IV bevacizumab would provide clinically meaningful improvement in 3-month PFS if it could demonstrate a 40% improvement relative to the historical data.|Z statistic|Z statistic was used to reject the null hypothesis provided Z\>=1.65, where Z = (KM estimate at 3 months - null hypothesis value \[50%\])/Greenwood SE.||||76.9|49.3|0.017
71841862|NCT05838027|143194257|SUPERIORITY|All panel-data marginal models use robust standard errors. Categorical outcomes were assessed with ordered logistic models and continuous outcomes were assessed with GEE population-averaged models, except Medication Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.75|||||TWO_SIDED|95.0|-1.29|-0.21||||||||-0.21|-1.29|
71804956|NCT01227889|143109827|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.2|0.61|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||0.61|0.20|
71804957|NCT01227889|143109828|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.57|1.18|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.|||1.18|0.57|
71804958|NCT02504294|143109865|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).|Difference in Percentage|-1.3975|||||TWO_SIDED|95.0|-7.6503|4.8553||||||Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).||4.8553|-7.6503|
71804959|NCT02504294|143109866|SUPERIORITY_OR_OTHER||LS Mean Difference|-1062.0|STANDARD_ERROR_OF_MEAN|803.95||0.1874|TWO_SIDED|95.0|-2643.2|519.2|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.||519.2|-2643.2|0.1874
71804960|NCT00366626|143109874|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_DEVIATION|6.32||0.51|TWO_SIDED|95.0|-1.85|3.69|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by two medication (naltrexone vs placebo) design. The main hypothesis was that the effect of naltrexone (mean naltrexone drinking - placebo drinking) would be greater in the 40asp subjects than in the asn40asn subjects. Thus the null hypothesis there would be no gene by medication interaction. The mean difference above is then the difference in the size of the naltrexone effect in the two genotypes, equivalent to the interaction.||3.69|-1.85|0.51
71804961|NCT00366626|143109875|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_DEVIATION|6.1||0.28|TWO_SIDED|95.0|-1.22|4.11|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by 2 medication (naltrexone vs. placebo)interaction analysis. The main hypothesis was that subjects who had 40asp OPRM1 allele would a greater naltrexone effect on drinking (Placebo - Naltrexxone) than the asn40asn subjects. Thus the null hypothesis was the gene by medication interaction.||4.11|-1.22|0.28
71804962|NCT02255175|143109888|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|t=.501, df=33||||||.620
71804963|NCT02255175|143109889|SUPERIORITY|||||||0.855|||||||t-test, 2 sided|t=.185, df=33||||||.855
71804964|NCT02255175|143109890|SUPERIORITY|||||||0.758|||||||t-test, 2 sided|t=-.310, df=33||||||.758
71804965|NCT02255175|143109891|SUPERIORITY|||||||0.518|||||||t-test, 2 sided|t=.653, df=33||||||.518
71804966|NCT02255175|143109892|SUPERIORITY|||||||0.645|||||||t-test, 2 sided|t=.465, df=33||||||.645
71804967|NCT02255175|143109893|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|t=2.56, df=33||||||.015
71804968|NCT02255175|143109894|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|t=.705, df=33||||||.486
71804969|NCT02255175|143109895|SUPERIORITY|||||||0.831|||||||t-test, 2 sided|t=.216, df=33||||||.831
71841863|NCT05838027|143194260|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.57|||||TWO_SIDED|95.0|-1.9|3.03||||||||3.03|-1.90|
71841864|NCT05838027|143194261|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.32|0.58||||||||0.58|-0.32|
71841865|NCT05838027|143194262|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|IRR|0.62|||||TWO_SIDED|95.0|0.23|1.63||||||||1.63|0.23|
71804970|NCT02255175|143109896|SUPERIORITY|||||||0.0002|||||||Repeated measures ANOVA|F(1,33)=17.91||||||.0002
71804971|NCT00167544|143109902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4|||<|0.05|TWO_SIDED|95.0|-19.49|30.29|||ANCOVA|||The primary analysis of total brain tissue volume was performed using multiple linear regression controlling for postmenstrual age at MRI scan to adjust for differences in timing at MRI. The distributions of potentially important confounding variables at baseline were compared in the two groups using parametric and non-parametric tests as appropriate. All analyses were performed using STATA 11.0. Please see PubMed: 23140612.||30.29|-19.49|<0.05
71804972|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-1.42|1.12|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.12|-1.42|
71804973|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.93|0.17|||||Total effect of zanamivir prophylaxis|||0.17|-0.93|
71804974|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-0.75|0.47|||||Direct effect of zanamivir prophylaxis when index is treated|||0.47|-0.75|
71894333|NCT01142323|143310743|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|95.0|||||Matched pairs|||||||0.008
71894334|NCT01142323|143310744|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71804975|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.23|||||TWO_SIDED|95.0|-1.15|1.62|||||Risk in cohort 1 minus risk in cohort 2|||1.62|-1.15|
71804976|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.51|0.03|||||Protective effect of zanamivir on susceptible risk|||0.03|-0.51|
71804977|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of Zanamivir prophylaxis on influenza risk|||1.01|0.99|
71804978|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
71804979|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
71804980|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|0.99|
71804981|NCT01156701|143109945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
71804982|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-1.17|0.36|||||Direct effect of Zanamivir prophylaxis on asthma risk|||0.36|-1.17|
71804983|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.38|||||TWO_SIDED|95.0|-0.8|0.03|||||Total effect of zanamivir prophylaxis|||0.03|-0.80|
71804984|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.28|||||TWO_SIDED|95.0|-0.75|0.18|||||Direct effect of zanamivir prophylaxis when index is treated|||0.18|-0.75|
71804985|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02|||||TWO_SIDED|95.0|-0.89|0.85|||||Risk in cohort 1 minus risk in cohort 2|||0.85|-0.89|
71804986|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.31|0.11|||||Protective effect of zanamivir on susceptible risk|||0.11|-0.31|
71804987|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of Zanamivir prophylaxis on asthma risk|||1.00|0.99|
71841866|NCT05838027|143194263|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|1.05|||||TWO_SIDED|95.0|-0.54|2.64||||||||2.64|-0.54|
71841867|NCT05838027|143194264|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.19|5.49||||||||5.49|0.19|
71894335|NCT02158533|143310748|SUPERIORITY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.14||0.109|TWO_SIDED|95.0|-4.1|0.4||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.||0.4|-4.1|0.109
71804988|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
71804989|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.99|
71804990|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Risk in cohort 1 minus risk in cohort 2|||1.01|0.99|
71804991|NCT01156701|143109946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
71804992|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.46|||||TWO_SIDED|95.0|-0.61|1.54|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.54|-0.61|
71804993|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.45|-0.04|||||Total effect of zanamivir prophylaxis|||-0.04|-0.45|
71804994|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.15|||||TWO_SIDED|95.0|-0.39|0.09|||||Direct effect of zanamivir prophylaxis when index is treated|||0.09|-0.39|
71804995|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.72|||||TWO_SIDED|95.0|-0.38|1.81|||||Risk in cohort 1 minus risk in cohort 2|||1.81|-0.38|
71804996|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.22|0.02|||||Protective effect of zanamivir on susceptible risk|||0.02|-0.22|
71804997|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.02|||||Direct effect of Zanamivir prophylaxis on pneumonia risk|||1.02|0.99|
71804998|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Total effect of zanamivir prophylaxis|||1.00|1.00|
71804999|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|1.00|
71805000|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Risk in cohort 1 minus risk in cohort 2|||1.02|1.00|
71841868|NCT05838027|143194265|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-2.64|0.43||||||||0.43|-2.64|
71805001|NCT01156701|143109947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
71805002|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.28|||||TWO_SIDED|95.0|-0.83|3.4|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||3.40|-0.83|
71805003|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.24|||||TWO_SIDED|95.0|-0.98|0.47|||||Total effect of zanamivir prophylaxis|||0.47|-0.98|
71805004|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.85|0.67|||||Direct effect of zanamivir prophylaxis when index is treated|||0.67|-0.85|
71805005|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.53|||||TWO_SIDED|95.0|-0.7|3.76|||||Risk in cohort 1 minus risk in cohort 2|||3.76|-0.70|
71805006|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.16|||||TWO_SIDED|95.0|-0.44|0.12|||||Protective effect of zanamivir on susceptible risk|||0.12|-0.44|
71805007|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||Direct effect of Zanamivir prophylaxis on bronchitis risk|||1.03|0.99|
71805008|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.99|
71805009|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Direct effect of zanamivir prophylaxis when index is treated|||1.01|0.99|
71805010|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.99|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.99|
71675482|NCT03307252|142868335|OTHER||Adjusted gMean ratio|135.07|STANDARD_ERROR_OF_MEAN|19.6|||TWO_SIDED|90.0|117.83|154.84|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|154.84|117.83|
71805011|NCT01156701|143109948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|1.00|
71805012|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14|||||TWO_SIDED|95.0|-3.08|2.79|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||2.79|-3.08|
71805013|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.07|||||TWO_SIDED|95.0|-2.39|0.25|||||Total effect of zanamivir prophylaxis|||0.25|-2.39|
71805014|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.08|||||TWO_SIDED|95.0|-2.51|0.35|||||Direct effect of zanamivir prophylaxis when index is treated|||0.35|-2.51|
71805015|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.93|||||TWO_SIDED|95.0|-2.29|4.14|||||Risk in cohort 1 minus risk in cohort 2|||4.14|-2.29|
71805016|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.01|||||TWO_SIDED|95.0|-0.58|0.59|||||Protective effect of zanamivir on susceptible risk|||0.59|-0.58|
71805017|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.97|1.03|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis|||1.03|0.97|
71805018|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Total effect of zanamivir prophylaxis|||1.00|0.98|
71805019|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.0|||||Direct effect of zanamivir prophylaxis when index is treated|||1.00|0.98|
71805020|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.04|||||Risk in cohort 1 minus risk in cohort 2|||1.04|0.98|
71805021|NCT01156701|143109949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk|||1.00|0.99|
71805022|NCT03819660|143109991|OTHER||percentage|38.5|||||TWO_SIDED|||||||||||||
71805023|NCT01136291|143109999|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||The homogeneity between the groups was compared by the Student's t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student's t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.||||<0.05
71805024|NCT02308033|143110006|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71805025|NCT02308033|143110007|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71805026|NCT02308033|143110008|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of normal Nugent scores at 7-14 days||||<0.001
71805027|NCT02308033|143110009|SUPERIORITY|||||||0.034|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.034
71805028|NCT03176693|143110022|EQUIVALENCE|A power analysis was calculated based on findings reported by Weingarten et al. of more frequent episodes of hypotension (defined as difference of mean systolic blood pressure \<30% from baseline) in phenoxybenzamine compared with doxazosin (15.7% versus 5.1%). Using a standard deviation of 16 and 11 (derived from reported interquartile ranges, assuming normal distribution), respectively, to achieve 80% power using an alpha =.05, a total sample size of 56 patients was determined.||||||0.56||||||Threshold for statistical significance = 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: hemodynamic instability time will not differ between arms||||.56
71805029|NCT02279641|143110028|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|133.0|||||TWO_SIDED|90.0|111.0|159.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||159|111|
71805030|NCT02279641|143110028|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|67.9|||||TWO_SIDED|90.0|65.2|70.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||70.7|65.2|
71805031|NCT02279641|143110030|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|93.3|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|93.3|
71805032|NCT02279641|143110030|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
71805033|NCT02279641|143110030|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|90.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
71841869|NCT05838027|143194266|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|2.72|||||TWO_SIDED|95.0|-1.35|6.8||||||||6.80|-1.35|
71841870|NCT05838027|143194267|SUPERIORITY|All panel-data marginal models use robust standard errors. The binary outcome, Future Preference: Behavioral task was assessed with a logistic model and continuous outcomes were assessed with GEE population-averaged models, except All Health Care Expenditures which used Poisson models to account for count data. Some outcomes are missing additional data (not \>10%).|Mean Difference (Net)|-0.69|||||TWO_SIDED|95.0|-1.74|0.36||||||||0.36|-1.74|
71805034|NCT02279641|143110031|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|94.9|112.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||112|94.9|
71805035|NCT02279641|143110031|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||TWO_SIDED|90.0|58.1|65.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||65.7|58.1|
71805036|NCT02279641|143110033|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|89.5|||||TWO_SIDED|90.0|81.8|98.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||98.0|81.8|
71805037|NCT02279641|143110033|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|119.0|||||TWO_SIDED|90.0|114.0|125.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||125|114|
71805038|NCT02279641|143110034|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|87.5|||||TWO_SIDED|90.0|79.3|96.6|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||96.6|79.3|
71805039|NCT02279641|143110034|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|193.0|||||TWO_SIDED|90.0|177.0|210.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||210|177|
71805040|NCT02279641|143110034|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|105.0|||||TWO_SIDED|90.0|94.4|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|94.4|
71805041|NCT02279641|143110037|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.7|||||TWO_SIDED|95.0|87.7|111.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||111|87.7|
71805042|NCT02279641|143110038|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
71805043|NCT02279641|143110039|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||TWO_SIDED|95.0|88.4|104.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||104|88.4|
71805044|NCT02279641|143110040|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|95.0|86.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||117|86.7|
71805045|NCT03021187|143110041|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.3|-0.7|< 0.0001
71805046|NCT03021187|143110041|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.7|-1.1|< 0.0001
71805047|NCT03021187|143110041|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-1.4|< 0.0001
71813550|NCT04858802|143129473|SUPERIORITY||Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|12.64||0.063|TWO_SIDED|95.0|-5.7|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.2|-5.7|0.063
71675483|NCT03307252|142868335|OTHER||Adjusted gMean Ratio|112.31|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|102.26|123.35|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|123.35|102.26|
71675484|NCT03307252|142868335|OTHER||Adjusted gMean Ratio|1125.1|STANDARD_ERROR_OF_MEAN|30.1|||TWO_SIDED|90.0|914.63|1384.0|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|1384.00|914.63|
71675485|NCT03307252|142868336|OTHER||Adjusted geometric mean (gMean) ratio|218.26|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|180.19|264.36|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|264.36|180.19|
71675486|NCT03307252|142868336|OTHER||Adjusted gMean ratio|104.78|STANDARD_ERROR_OF_MEAN|21.0|||TWO_SIDED|90.0|89.97|122.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|122.03|89.97|
71675487|NCT03307252|142868336|OTHER||Adjusted gMean Ratio|122.65|STANDARD_ERROR_OF_MEAN|20.1|||TWO_SIDED|90.0|107.68|139.69|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|139.69|107.68|
71805048|NCT03021187|143110041|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.4|-0.7|<0.0001
71805049|NCT03021187|143110041|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.2|<0.0001
71805050|NCT03021187|143110041|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.6|<0.0001
71813551|NCT04858802|143129474|SUPERIORITY||Mean Difference (Final Values)|50.94|STANDARD_DEVIATION|430.8||0.306|TWO_SIDED|95.0|-47.5|149.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||149.4|-47.5|0.306
71813552|NCT04858802|143129474|SUPERIORITY||Mean Difference (Final Values)|-27.44|STANDARD_DEVIATION|413.22||0.567|TWO_SIDED|95.0|-122.5|67.6|||t-test, 2 sided|Paired; the threshold for statistical significance was p = 0.05.|Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||67.6|-122.5|0.567
71841871|NCT03550170|143194268|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|4.89|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|90.0|0.67|9.11|||||Comparison of teleconference to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||9.11|0.67|
71841872|NCT03550170|143194268|NON_INFERIORITY|Non-inferiority was established using the prespecified margin of inferiority of 10 points on the total composite score of the Fatigue Impact Scale.|Slope|6.12|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|90.0|0.98|11.26|||||Comparison of internet to one-to-one at 6 months.|A generalized estimating equation (GEE) served as the primary analysis tool for modeling the longitudinal scores of the primary outcome - Fatigue Impact Scale (FIS).||11.26|0.98|
71841873|NCT03550170|143194269|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
71841874|NCT05683340|143194308|SUPERIORITY||Least squares mean difference|-21.78|STANDARD_ERROR_OF_MEAN|2.482||0.001|TWO_SIDED|95.0|-26.71|-16.85|||MMRM||The least squares mean difference was calculated as the value for the ETC-1002 180 mg arm minus the value for the placebo arm.|||-16.85|-26.71|0.001
71841875|NCT03687762|143194327|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841876|NCT03687762|143194328|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841877|NCT03687762|143194329|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841878|NCT03687762|143194330|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841879|NCT03687762|143194331|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841880|NCT03687762|143194332|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.||||||0.01|||||||ANOVA|||||||0.01
71841881|NCT03687762|143194333|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841882|NCT03687762|143194334|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841883|NCT03687762|143194335|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce a greater proportion of people decreasing their dose relative to those increasing their dose during treatment.|||||>|0.05|||||||Chi-squared|||||||>.05
71841884|NCT03687762|143194336|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841885|NCT03687762|143194337|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841886|NCT03687762|143194338|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841887|NCT03687762|143194339|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841888|NCT03687762|143194340|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841889|NCT03687762|143194341|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841890|NCT03687762|143194342|OTHER|We hypothesized negligible between condition differences, although within each condition, we hypothesized that each treatment would produce medium effect size improvements.|||||>|0.05|||||||ANOVA|||||||>.05
71841891|NCT04200313|143194402|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841892|NCT04200313|143194402|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841893|NCT04200313|143194403|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841894|NCT04200313|143194403|NON_INFERIORITY|Non-inferiority with a 1% non-inferiority margin|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841895|NCT04200313|143194404|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841896|NCT04200313|143194404|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841897|NCT04200313|143194405|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841898|NCT04200313|143194405|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841899|NCT04200313|143194406|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841900|NCT04200313|143194406|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841901|NCT04200313|143194407|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841902|NCT04200313|143194407|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841903|NCT04200313|143194408|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841904|NCT04200313|143194408|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71841905|NCT04200313|143194409|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||||||0.51
71841906|NCT04200313|143194409|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71841907|NCT03580356|143194477|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|9.029|||<|0.0001|TWO_SIDED|95.0|3.183|25.615|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||25.615|3.183|<.0001
71841908|NCT03580356|143194477|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.926||||0.6646|TWO_SIDED|95.0|0.65|1.319|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.319|0.650|0.6646
71841909|NCT03580356|143194477|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|11.508|||<|0.0001|TWO_SIDED|95.0|4.058|32.638|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||32.638|4.058|<.0001
71841910|NCT03580356|143194477|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio, log|1.181||||0.173|TWO_SIDED|95.0|0.836|1.667|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.667|0.836|0.1730
71841911|NCT03580356|143194478|SUPERIORITY||LS Mean|-9.997|STANDARD_ERROR_OF_MEAN|1.305|<|0.0001|TWO_SIDED|95.0|-12.554|-7.439|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-7.439|-12.554|<.0001
71841912|NCT03580356|143194478|SUPERIORITY||LS mean|0.414|STANDARD_ERROR_OF_MEAN|0.922||0.6735|TWO_SIDED|95.0|-1.392|2.221|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||2.221|-1.392|0.6735
71841913|NCT03580356|143194478|SUPERIORITY||LS Mean|-11.091|STANDARD_ERROR_OF_MEAN|1.313|<|0.0001|TWO_SIDED|95.0|-13.664|-8.518|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||-8.518|-13.664|<.0001
71841914|NCT03580356|143194478|SUPERIORITY||LS mean|-0.68|STANDARD_ERROR_OF_MEAN|0.923||0.2305|TWO_SIDED|95.0|-2.489|1.128|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Treatment contrast in LS mean (change), Adults only||1.128|-2.489|0.2305
71841915|NCT03580356|143194480|SUPERIORITY||LS Mean|-4.105|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|-5.281|-2.929|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||-2.929|-5.281|<.0001
71841916|NCT03580356|143194480|SUPERIORITY||LS Mean|0.101|STANDARD_ERROR_OF_MEAN|0.422||0.5943|TWO_SIDED|95.0|-0.727|0.928|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.928|-0.727|0.5943
71841917|NCT03580356|143194480|SUPERIORITY|Adults only|LS Mean|-4.496|STANDARD_ERROR_OF_MEAN|0.603|<|0.0001|TWO_SIDED|95.0|-5.678|-3.314|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||||-3.314|-5.678|<.0001
71841918|NCT03580356|143194480|SUPERIORITY||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.423||0.2467|TWO_SIDED|95.0|-1.12|0.54|||Mixed Models Analysis|Linear mixed model with repeated measures (MMRM)||Adults only||0.540|-1.120|0.2467
71841919|NCT03580356|143194482|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|3.443|||<|0.0001|TWO_SIDED|95.0|1.955|6.063|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||6.063|1.955|<.0001
71841920|NCT03580356|143194482|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|0.838||||0.8524|TWO_SIDED|95.0|0.602|1.167|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.167|0.602|0.8524
71841921|NCT03580356|143194482|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|4.542|||<|0.0001|TWO_SIDED|95.0|2.577|8.004|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||8.004|2.577|<.0001
71841922|NCT03580356|143194482|SUPERIORITY|Wald chi-square test based on logistic regression|Odds Ratio (OR)|1.106||||0.2764|TWO_SIDED|95.0|0.794|1.54|||Regression, Logistic|95% confidence interval for the odds ratio||Adults only||1.540|0.794|0.2764
71841923|NCT03580356|143194483|SUPERIORITY||Risk Ratio (RR)|1.389|||<|0.0001|TWO_SIDED|95.0|1.235|1.561|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.561|1.235|<.0001
71841924|NCT03580356|143194483|SUPERIORITY||Risk Ratio (RR)|1.029||||0.2369|TWO_SIDED|95.0|0.952|1.111|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.111|0.952|0.2369
71841925|NCT03580356|143194483|SUPERIORITY||Risk Ratio (RR)|1.425|||<|0.0001|TWO_SIDED|95.0|1.268|1.603|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.603|1.268|<.0001
71841926|NCT03580356|143194483|SUPERIORITY||Risk Ratio (RR)|1.056||||0.083|TWO_SIDED|95.0|0.978|1.14|||Negative binomial regression model|95% confidence interval for the relative risk ratio||Adults only||1.140|0.978|0.0830
71841927|NCT05715528|143194485|SUPERIORITY||Hazard Ratio (HR)|1.099||||0.0681|TWO_SIDED|95.0|0.997|1.211||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% confidence interval (CI) for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.211|0.997|0.0681
71841928|NCT05715528|143194489|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.5558|TWO_SIDED|95.0|0.935|1.147|||Stratified Log-Rank Test|P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.147|0.935|0.5558
71841929|NCT05715528|143194490|SUPERIORITY|||||||0.6469|||||||Fisher's exact test|||||||0.6469
71841930|NCT05715528|143194491|SUPERIORITY||Hazard Ratio (HR)|0.495||||0.5581|TWO_SIDED|95.0|0.045|5.464|||Log-rank test|P value was based on log-rank test.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression.|||5.464|0.045|0.5581
71841931|NCT05715528|143194493|SUPERIORITY||Least Squares Mean|0.02||||0.4254|TWO_SIDED|95.0|-0.03|0.08||p-value was from Mixed-effects model repeated measures (MMRM) with baseline viral load and randomization strata as covariates.|MMRM||95% CI was from MMRM with baseline viral load and randomization strata as covariates.|||0.08|-0.03|0.4254
71841932|NCT05715528|143194494|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.0015|TWO_SIDED|95.0|1.032|1.256||P-value calculated from stratified Log-rank test with randomization stratification factor as the strata.|Stratified Log-rank test||Hazard ratio and two-sided 95% CI for hazard ratio were estimated using the Cox regression with randomization stratification factor as a covariate.|||1.256|1.032|0.0015
71841933|NCT05715528|143194495|SUPERIORITY|||||||0.6978|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.6978
71841934|NCT05715528|143194500|SUPERIORITY|||||||0.5707|||||||Fisher's exact test|P-value was from the Fisher's exact test.||||||0.5707
71841935|NCT03536884|143194514|NON_INFERIORITY|The evaluation of noninferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a noninferiority margin of 10%.|Risk Difference (RD)|12.682|||||TWO_SIDED|95.0|5.771|19.592||||||Risk Difference: BKZ-Secukinumab calculated using stratified Cochran-Mantel-Haenszel (CMH).||19.592|5.771|
71896330|NCT03114969|143314793|SUPERIORITY||Odds Ratio (OR)|3.196||||0.175|TWO_SIDED|95.0|0.596|17.14||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||17.140|0.596|0.175
71841936|NCT03536884|143194514|SUPERIORITY||Odds Ratio (OR)|1.714|||<|0.001|TWO_SIDED|95.0|1.271|2.31||P-values for the comparison of treatment groups are based on the CMH test for the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||2.310|1.271|<0.001
71841937|NCT03536884|143194515|SUPERIORITY||Odds Ratio (OR)|2.817|||<|0.001|TWO_SIDED|95.0|2.068|3.836||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.836|2.068|<0.001
71841938|NCT03536884|143194517|SUPERIORITY||Odds Ratio (OR)|2.49|||<|0.001|TWO_SIDED|95.0|1.835|3.377||P-values for the comparison of treatment groups are based on the CMH test from the general association. P-values are not controlled for multiplicity and should only be considered descriptively.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.377|1.835|<0.001
71841939|NCT03536884|143194517|SUPERIORITY||Odds Ratio (OR)|2.168|||<|0.001|TWO_SIDED|95.0|1.511|3.11||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.110|1.511|<0.001
71841940|NCT03536884|143194517|SUPERIORITY||Odds Ratio (OR)|3.243|||<|0.001|TWO_SIDED|95.0|2.103|5.0||P-values for the comparison of treatment groups are based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.000|2.103|<0.001
71841941|NCT03331835|143194524|SUPERIORITY||Risk Difference (RD)|42.86|||<|0.001|TWO_SIDED|95.0|30.93|54.79|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg).||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||54.79|30.93|<0.001
71841942|NCT03331835|143194525|SUPERIORITY||Risk Difference (RD)|44.76|||<|0.001|TWO_SIDED|95.0|32.81|56.71|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, \> 100 kg)||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||56.71|32.81|<0.001
71841943|NCT03331835|143194526|SUPERIORITY||Risk Difference (RD)|43.81|||<|0.001|TWO_SIDED|95.0|31.78|55.84|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||55.84|31.78|<0.001
71675488|NCT03307252|142868336|OTHER||Adjusted gMean Ratio|116.88|STANDARD_ERROR_OF_MEAN|14.4|||TWO_SIDED|90.0|105.07|130.03|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|130.03|105.07|
71675489|NCT03307252|142868337|OTHER||Adjusted geometric mean (gMean) ratio|87.07|STANDARD_ERROR_OF_MEAN|20.9|||TWO_SIDED|90.0|76.08|99.64|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.64|76.08|
71841944|NCT03331835|143194527|SUPERIORITY||Risk Difference (RD)|31.43|||<|0.001|TWO_SIDED|95.0|20.76|42.1|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.||42.10|20.76|<0.001
71841945|NCT03331835|143194528|SUPERIORITY||Mean Difference (Net)|-3.08|||<|0.001|TWO_SIDED|95.0|-4.83|-1.33|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-1.33|-4.83|<0.001
71894336|NCT02158533|143310748|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.17||0.975|TWO_SIDED|95.0|-2.3|2.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.||2.3|-2.3|0.975
71894337|NCT00917384|143310772|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.776||||0.0473||95.0|0.603|0.998|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.998|0.603|0.0473
71894338|NCT00917384|143310773|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.483|||<|0.0001|TWO_SIDED|95.0|0.376|0.62|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).||||0.620|0.376|<0.0001
71894339|NCT00917384|143310774|SUPERIORITY_OR_OTHER_LEGACY||Difference Between Arms|24.2|||<|0.0001|TWO_SIDED|95.0|14.9|33.6|||Normal Approximation|||||33.6|14.9|<0.0001
71675490|NCT03307252|142868337|OTHER||Adjusted gMean ratio|122.94|STANDARD_ERROR_OF_MEAN|18.0|||TWO_SIDED|90.0|110.25|137.09|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|137.09|110.25|
71841946|NCT03331835|143194529|SUPERIORITY||Mean Difference (Net)|-16.36|||<|0.001|TWO_SIDED|95.0|-23.03|-9.68|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-9.68|-23.03|<0.001
71841947|NCT03331835|143194530|SUPERIORITY||Mean Difference (Net)|-8.91|||<|0.001|TWO_SIDED|95.0|-13.0|-4.81|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.||-4.81|-13.00|<0.001
71841948|NCT03331835|143194534|SUPERIORITY||Mean Difference (Final Values)|-4.92|||<|0.001|TWO_SIDED|95.0|-6.31|-3.53|||ANCOVA|||The AUC was analysed using analysis of covariance (ANCOVA) with treatment group, baseline weight group, and the baseline PSI total score as explanatory variables. Treatment groups are defined as randomised treatment.||-3.53|-6.31|<0.001
71841949|NCT03331835|143194535|SUPERIORITY||Mean Difference (Net)|-2.57||||0.004|TWO_SIDED|95.0|-4.32|-0.82|||Mixed Models Analysis|||The endpoint is analysed by using mixed model for repeated measurements (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups are defined as randomised treatment.||-0.82|-4.32|0.004
71841950|NCT03331835|143194536|SUPERIORITY|Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (\<=100 kg, \> 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|Risk Difference (RD)|40.95|||<|0.001|TWO_SIDED|95.0|28.75|53.16|||Cochran-Mantel-Haenszel|||||53.16|28.75|<0.001
71841951|NCT03331835|143194537|SUPERIORITY|The endpoint was analysed by using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|Mean Difference (Net)|-1.72||||0.028|TWO_SIDED|95.0|-3.24|-0.19|||Mixed Models Analysis|||||-0.19|-3.24|0.028
71841952|NCT03314740|143194637|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.265|TWO_SIDED|90.0|0.5|1.14|||cox model|||||1.14|0.5|0.265
71894340|NCT00644592|143310820|SUPERIORITY_OR_OTHER||Ratio of mean effects|1.27|STANDARD_ERROR_OF_MEAN|0.16||0.015|TWO_SIDED|95.0|1.06|1.52|||t-test, 2 sided||The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size\[since (B-A)-(A-B)=2B-2A\] so the actual estimate was based upon the antilog of half of this difference.|This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.||1.52|1.06|0.015
71675491|NCT03307252|142868337|OTHER||Adjusted gMean Ratio|101.35|STANDARD_ERROR_OF_MEAN|12.0|||TWO_SIDED|90.0|93.65|109.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|109.70|93.65|
71841953|NCT03314740|143194637|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.904|TWO_SIDED|90.0|0.68|1.55|||cox- model|||||1.55|0.68|0.904
71841954|NCT02367040|143194651|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.52||||2e-06|TWO_SIDED|95.0|0.393|0.688||1-sided p-value|Log Rank|||At primary completion date||0.688|0.393|0.000002
71841955|NCT02367040|143194651|SUPERIORITY|PFS was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.557||||3e-06|TWO_SIDED|95.0|0.431|0.722||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.722|0.431|0.000003
71841956|NCT02367040|143194652|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|32.99|||<|1e-06|TWO_SIDED|95.0|23.95|42.03||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||42.03|23.95|<0.000001
71841957|NCT02367040|143194652|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in ORR|30.67|||<|1e-06|TWO_SIDED|95.0|21.63|39.72||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||39.72|21.63|<0.000001
71841958|NCT02367040|143194653|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|19.27|||<|1e-06|TWO_SIDED|95.0|11.57|26.96||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||26.96|11.57|<0.000001
71841959|NCT02367040|143194653|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in CRR|18.92||||1e-06|TWO_SIDED|95.0|11.11|26.73||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||26.73|11.11|0.000001
71841960|NCT02367040|143194654|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Kaplan-Meier estimates|0.7||||0.030371|TWO_SIDED|95.0|0.481|1.018||1-sided p-value|Log Rank|||At primary completion date||1.018|0.481|0.030371
71841961|NCT02367040|143194654|SUPERIORITY|DOR was evaluated with the stratified log-rank test. HR and 95% CI were based on stratified Cox Regression Model.|Hazard Ratio (HR)|0.761||||0.051976|TWO_SIDED|95.0|0.547|1.059||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.059|0.547|0.051976
71805051|NCT03021187|143110042|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9||||0.0392|TWO_SIDED|95.0|-1.8|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.0|-1.8|0.0392
71841962|NCT02367040|143194655|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At primary completion date||11.12|-2.26|0.097339
71841963|NCT02367040|143194655|SUPERIORITY|P-value from Cochran-Mantel-Haenszel (CMH) test stratified|Difference in DCR|4.43||||0.097339|TWO_SIDED|95.0|-2.26|11.12||1-sided p-value|Cochran-Mantel-Haenszel|||At 2-year follow-up cut-off date||11.12|-2.26|0.097339
71841964|NCT02367040|143194656|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.476|||<|1e-06|TWO_SIDED|95.0|0.357|0.635||1-sided p-value|Log Rank|||At primary completion date||0.635|0.357|<.000001
71841965|NCT02367040|143194656|SUPERIORITY|TTP was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.505|||<|1e-06|TWO_SIDED|95.0|0.387|0.659||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||0.659|0.387|<.000001
71841966|NCT02367040|143194658|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.06||||0.69261|TWO_SIDED|95.0|0.843|1.331||1-sided p-value|Log Rank|||At primary completion date||1.331|0.843|0.692610
71841967|NCT02367040|143194658|SUPERIORITY|Time to deterioration in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.047||||0.661145|TWO_SIDED|95.0|0.841|1.302||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.302|0.841|0.661145
71813553|NCT04858802|143129475|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_DEVIATION|1.92||0.031|TWO_SIDED|95.0|0.0|0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||0.9|0.0|0.031
71813554|NCT04858802|143129475|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.27||0.943|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.5|0.943
71841968|NCT02367040|143194659|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|0.996||||0.510038|TWO_SIDED|95.0|0.732|1.355||1-sided p-value|Log Rank|||At primary completion date||1.355|0.732|0.510038
71841969|NCT02367040|143194659|SUPERIORITY|Time to improvement in DRS-P was evaluated with the stratified log-rank test. HR and 95% CI were based on Cox Regression Model.|Hazard Ratio (HR)|1.036||||0.40597|TWO_SIDED|95.0|0.768|1.398||1-sided p-value|Log Rank|||At 2-year follow-up cut-off date||1.398|0.768|0.405970
71841970|NCT04934072|143194691|NON_INFERIORITY|Non-inferiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely above -1.45%.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|-0.05|0.96|||||Difference : FKS518 - US-Prolia|||0.96|-0.05|
71841971|NCT04934072|143194691|OTHER|Non-superiority Analysis: Non-superiority of FKS518 to US-Prolia was demonstrated if the 90% CI for the difference in mean percent change from baseline to Week 52 in LS-BMD laid entirely below 1.45%.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.306|||TWO_SIDED|90.0|0.19|1.2|||||Difference : FKS518 - US-Prolia|||1.20|0.19|
71841972|NCT03421340|143194706|NON_INFERIORITY|Non-Inferiority Margin of 10%|Risk Difference (RD)|1.8||||0.029|TWO_SIDED||||||exact|||||||0.029
71841973|NCT03421340|143194707|SUPERIORITY|Not powered|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-8.0|4.1||||||||4.1|-8|
71841974|NCT03421340|143194708|SUPERIORITY||Median Difference (Net)|133.0|||||TWO_SIDED|95.0|120.0|143.0||||||||143|120|
71841975|NCT03421340|143194709|SUPERIORITY||Median Difference (Final Values)|-10.2|||||TWO_SIDED|95.0|-11.6|-7.5||||||||-7.5|-11.6|
71841976|NCT05736458|143194748|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.66|TWO_SIDED||||||t-test, 2 sided|||Of the 23 participants who completed all study procedures, 2 participant's data was unusable for this analysis. Statistics are from paired 2 tailed t-test comparing pre-rTMS 2-back percent accuracy scores for participant's high and low controllability target.||||0.66
71841977|NCT05736458|143194749|SUPERIORITY||Mean Difference (Final Values)|1.94||||0.43|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from 2-tailed t-test comparing pre-rTMS to post-rTMS 2-back accuracy scores for a high controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||0.43
71841978|NCT05736458|143194749|SUPERIORITY||Mean Difference (Final Values)|6.36|||<|0.04|TWO_SIDED||||||t-test, 2 sided|df = 20||Statistics are from 2-tailed t-test comparing pre-rTMS and post-rTMS 2-back percent accuracy scores for a low controllability TMS target. Alternative hypothesis: true mean is not equal to 0.||||<0.04
71841979|NCT05736458|143194750|SUPERIORITY||Mean Difference (Final Values)|11.54|||<|0.05|TWO_SIDED||||||t-test, 2 sided|df = 11||Statistics are from 2-tailed paired t-test comparing 2-back accuracy score before and after rTMS to a high controllability target. Alternative hypothesis: true mean is not equal to 0.||||<0.05
71841980|NCT05736458|143194751|SUPERIORITY||Mean Difference (Net)|-4.42||||0.27|TWO_SIDED||||||t-test, 2 sided|df = 19||Statistics are from paired 2 tailed t-test comparing 2-back percent changes (Post-rTMS - pre-rTMS) scores for participant's high and low controllability target. Alternative hypothesis: true mean is not equal to 0.||||0.27
71841981|NCT02990338|143194752|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.596||||0.0005|TWO_SIDED|95.0|0.436|0.814||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.|Log Rank|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Stratification was based on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \>3) according to IRT.|Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.||0.814|0.436|0.0005
71841982|NCT02990338|143194753|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|||||<|0.0001||||||Threshold for statistical significance at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.||||||<0.0001
71841983|NCT02990338|143194757|SUPERIORITY|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.776||||0.0319|TWO_SIDED|95.0|0.594|1.015||One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.|Log Rank|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.|||1.015|0.594|0.0319
71841984|NCT02997202|143194776|SUPERIORITY||Hazard Ratio (HR)|0.679||||0.0518|TWO_SIDED|95.0|0.459|1.005|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.005|0.459|0.0518
71894341|NCT00892437|143310852|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group - RTV group) in the response rate at Week 24 was greater than -12%.|Difference in percentages|-7.4|||||TWO_SIDED|95.0|-24.6|9.9|||||Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.||9.9|-24.6|
71894342|NCT00892437|143310853|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.3|||||TWO_SIDED|95.0|-25.9|9.4|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||9.4|-25.9|
71894343|NCT00892437|143310854|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-0.02||||0.87|TWO_SIDED|95.0|-0.25|0.22||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.22|-0.25|0.87
71894344|NCT00892437|143310855|SUPERIORITY_OR_OTHER||Difference in LSM|-0.03||||0.82|TWO_SIDED|95.0|-0.3|0.23||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||0.23|-0.30|0.82
71841985|NCT02997202|143194777|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.4394|TWO_SIDED|95.0|0.554|1.293|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.293|0.554|0.4394
71841986|NCT02997202|143194780|SUPERIORITY||Hazard Ratio (HR)|2.308||||0.0209|TWO_SIDED|95.0|1.1352|4.6922|||Fine-Grays Model|||Based on Fine \& Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||4.6922|1.1352|0.0209
71841987|NCT02997202|143194781|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6417|TWO_SIDED|95.0|0.686|1.261|||Log Rank|||Stratification factors were conditioning regimen intensity MAC vs RIC/NMA, time from transplant to randomization (30 to 60 days vs 61 to 90 days), and the presence of MRD (present vs absent/unknown) based on the pre-transplant BM aspirate.||1.261|0.686|0.6417
71894345|NCT00892437|143310856|SUPERIORITY_OR_OTHER||Difference in LSM|10.0||||0.78|TWO_SIDED|95.0|-63.0|84.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||84|-63|0.78
71805052|NCT03021187|143110042|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.0||||0.0001|TWO_SIDED|95.0|-3.0|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.0|-3.0|0.0001
71805053|NCT03021187|143110042|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.2|-2.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.3|-4.2|<0.0001
71805054|NCT03021187|143110042|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.9||||0.0111|TWO_SIDED|95.0|-1.6|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-1.6|0.0111
71805055|NCT03021187|143110042|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.8|-3.2|<0.0001
71805056|NCT03021187|143110042|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.4|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.0|-4.4|<0.0001
71805057|NCT03021187|143110062|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.73||||0.0627|TWO_SIDED|95.0|0.53|1.02||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.02|0.53|0.0627
71805058|NCT03021187|143110062|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.0083|TWO_SIDED|95.0|0.44|0.89||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.89|0.44|0.0083
71805059|NCT03021187|143110062|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.57||||0.0019|TWO_SIDED|95.0|0.4|0.81||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.81|0.40|0.0019
71805060|NCT03021187|143110063|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.121|TWO_SIDED|95.0|0.53|1.08||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.08|0.53|0.1210
71894346|NCT00892437|143310857|SUPERIORITY_OR_OTHER||Difference in LSM|47.0||||0.29|TWO_SIDED|95.0|-41.0|134.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||134|-41|0.29
71894347|NCT02750410|143310858|SUPERIORITY||LS mean percent difference|-1.5|||<|0.001|TWO_SIDED|95.0|-1.73|-1.28|||Mixed Models Analysis|||||-1.28|-1.73|<0.001
71894348|NCT02750410|143310859|SUPERIORITY||Odds Ratio (OR)|0.117||||0.003|TWO_SIDED|95.0|0.028|0.479|||Regression, Logistic|||analysis was based on repeated measures logistic regression||0.479|0.028|0.003
71894349|NCT02750410|143310860|SUPERIORITY||LS mean difference|-30.14|||<|0.001|TWO_SIDED|95.0|-41.37|-18.91|||Mixed Models Analysis|||||-18.91|-41.37|<0.001
71805061|NCT03021187|143110063|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.0007|TWO_SIDED|95.0|0.32|0.74||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.74|0.32|0.0007
71805062|NCT03021187|143110063|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0006|TWO_SIDED|95.0|0.31|0.73||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.73|0.31|0.0006
71805063|NCT01664078|143110078|OTHER|The Intent-to-Treat (ITT) analysis set includes all subjects who had the aortic bifurcate device introduced into the body. This ITT analysis set will be used for all safety and clinical assessment endpoints.||||||0.47|||||||Mixed Models Analysis|||||||0.47
71805064|NCT01422070|143110094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63|||<|0.05|TWO_SIDED|95.0|0.45|0.88|||generalized estimating equation|Generalized estimating equation adjusts the confidence interval for the correlation of outcomes within-centre.|The fully adjusted multivariable logistic regression analysis showed an OR of 0.63 in favour of the presence of an intermediate care unit in the hospital|The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospital||0.88|0.45|<0.05
71805065|NCT03351049|143110095|SUPERIORITY|||||||0.8|||||||Chi-squared|||Compare the effectiveness of reactive support surfaces with and without low air loss in preventing pressure injuries||||0.8
71805066|NCT02877485|143110096|OTHER||Mean Difference (Net)|1.5||||0.7|TWO_SIDED|95.0|-6.0|8.9||"Statistical Tests:~Independent t-test to assess differences in mean change in NOSE scores when comparing the two study groups, and p\<0.05 deemed statistically significant"|t-test, 2 sided||Change in Mean NOSE score from baseline to post saline versus change in NOSE score from baseline to post intranasal steroid.|"1\) H0: mean change in NOSE score from baseline after in study group 1 = mean change in NOSE score from baseline in study group 2~Power calculation: To detect a 20% difference in NOSE scores with 80% power and a 2-sided alpha level of 0.05 required 20 participants per study group, for a total of 40 participants."||8.9|-6.0|0.7
71805067|NCT02877485|143110097|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_DEVIATION|27.6|<|0.001|TWO_SIDED|||||Paired t-tests to assess differences in mean NOSE score when the treatment groups were combined (saline arm+ steroid arm) at five post-operative time intervals compared to the combined preoperative baseline scores. Significance at p\<0.05.|Paired t-test|||H0: Mean pre- treatment baseline patient NOSE score = Mean post- treatment baseline patient NOSE score.||||<0.001
71805068|NCT03762135|143110140|SUPERIORITY|||||||0.044||||||This relates to the entirety of the 6-week period.|GEE Linear Regression|Generalized Estimation Equation Linear Regression||||||0.044
71805069|NCT02005471|143110155|SUPERIORITY||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.18|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified analysis: 17p deletion, risk status, geographic region.||0.29|0.18|<.0001
71805070|NCT02005471|143110155|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model|Unstratified Analysis||0.31|0.19|<.0001
71805071|NCT02005471|143110157|SUPERIORITY||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.13|0.28|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.28|0.13|<.0001
71805072|NCT02005471|143110157|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.3|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.30|0.14|<.0001
71805073|NCT02005471|143110159|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.57|0.21|<.0001
71805074|NCT02005471|143110159|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.22|0.56|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.56|0.22|<.0001
71805075|NCT02005471|143110161|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.49|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.||0.49|0.09|<.0001
71805076|NCT02005471|143110161|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.0001|TWO_SIDED|95.0|0.09|0.46|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.46|0.09|<.0001
71805077|NCT02005471|143110162|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
71805078|NCT02005471|143110162|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
71805079|NCT02005471|143110163|SUPERIORITY||Difference in Response Rates|25.61|||<|0.0001|TWO_SIDED|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||95% CI for rates were constructed using Pearson- Clopper method. 95% CI for difference in rates were constructed using Anderson-Hauck method.|||33.33|17.88|<.0001
71894350|NCT02750410|143310861|SUPERIORITY||LS mean difference|-26.59|||<|0.001|TWO_SIDED|95.0|-36.39|-16.78|||t-test, 2 sided|||Prebreakfast BG||-16.78|-36.39|<0.001
71894351|NCT02750410|143310861|SUPERIORITY||LS mean difference|-45.38|||<|0.001|TWO_SIDED|95.0|-61.77|-29.0|||t-test, 2 sided|||Breakfast 2-hour PPBG||-29.00|-61.77|<0.001
71894352|NCT02750410|143310861|SUPERIORITY||LS mean difference|-36.82|||<|0.001|TWO_SIDED|95.0|-49.2|-24.45|||t-test, 2 sided|||Prelunch BG||-24.45|-49.20|<0.001
71805080|NCT02005471|143110163|SUPERIORITY||Odds Ratio (OR)|7.81|||||TWO_SIDED|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||15.37|3.97|
71894353|NCT02750410|143310861|SUPERIORITY||LS mean difference|-50.16|||<|0.001|TWO_SIDED|95.0|-67.85|-32.46|||t-test, 2 sided|||Lunch 2-hour PPBG||-32.46|-67.85|<0.001
71894354|NCT02750410|143310861|SUPERIORITY||LS mean difference|-31.27|||<|0.001|TWO_SIDED|95.0|-44.05|-18.48|||t-test, 2 sided|||Predinner BG||-18.48|-44.05|<0.001
71894355|NCT02750410|143310861|SUPERIORITY||LS mean difference|-34.97|||<|0.001|TWO_SIDED|95.0|-52.55|-17.38|||t-test, 2 sided|||Dinner 2-hour PPBG||-17.38|-52.55|<0.001
71894356|NCT02750410|143310861|SUPERIORITY||LS mean difference|-41.45|||<|0.001|TWO_SIDED|95.0|-58.81|-24.09|||t-test, 2 sided|||Bedtime BG||-24.09|-58.81|<0.001
71894357|NCT02750410|143310862|SUPERIORITY||LS mean difference|0.1||||0.776|TWO_SIDED|95.0|-0.59|0.78|||Mixed Models Analysis|||||0.78|-0.59|0.776
71894358|NCT04112914|143310885|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.021|TWO_SIDED||||||Regression, Linear|||||||0.021
71894359|NCT04112914|143310886|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.638|TWO_SIDED||||||Regression, Linear|||||||0.638
71894360|NCT04112914|143310887|SUPERIORITY||Odds Ratio (OR)|1.77||||0.338|TWO_SIDED|95.0|0.55|5.72|||Regression, Logistic|||||5.72|0.55|0.338
71805081|NCT02005471|143110164|SUPERIORITY||Difference in Response Rates|25.07|||<|0.0001|TWO_SIDED|95.0|16.63|33.51|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.51|16.63|<.0001
71805082|NCT02005471|143110164|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.88|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.88|2.68|
71805083|NCT02005471|143110165|SUPERIORITY||Difference in Response Rates|24.55|||<|0.0001|TWO_SIDED|95.0|16.0|33.1|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.|||33.10|16.00|<.0001
71805084|NCT02005471|143110165|SUPERIORITY||Odds Ratio (OR)|4.59|||||TWO_SIDED|95.0|2.68|7.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||7.85|2.68|
71805085|NCT02005471|143110167|SUPERIORITY|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.37|0.74|||Log Rank||Hazard ratio was estimated by Cox regression model.|||0.74|0.37|0.0002
71805086|NCT02005471|143110167|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0003|TWO_SIDED|95.0|0.39|0.76|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.76|0.39|0.0003
71805087|NCT02005471|143110169|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.17|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.29|0.17|<.0001
71805088|NCT02005471|143110169|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.19|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.31|0.19|<.0001
71805089|NCT02005471|143110173|SUPERIORITY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.39|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.||0.39|0.23|<.0001
71805090|NCT02005471|143110173|SUPERIORITY||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.25|0.41|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis||0.41|0.25|<.0001
71805091|NCT02005471|143110174|SUPERIORITY||Difference in MRD Negativity Rates|49.04|||<|0.0001|TWO_SIDED|95.0|40.44|57.64|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||57.64|40.44|<.0001
71805092|NCT02005471|143110174|SUPERIORITY||Odds Ratio (OR)|10.77|||||TWO_SIDED|95.0|6.5|17.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||17.85|6.50|
71805093|NCT02005471|143110175|SUPERIORITY||Difference in MRD negative rates|13.41|||<|0.0001|TWO_SIDED|95.0|7.99|18.82|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.|||18.82|7.99|<.0001
71805094|NCT02005471|143110175|SUPERIORITY||Odds Ratio (OR)|16.28|||||TWO_SIDED|95.0|3.82|69.35|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.|||69.35|3.82|
71805095|NCT02730819|143110191|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
71805096|NCT02730819|143110192|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.||||0.006
71805097|NCT00360529|143110229|SUPERIORITY_OR_OTHER|||||||0.0454||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 50 mg qhs versus placebo||||0.0454
71805098|NCT00360529|143110229|SUPERIORITY_OR_OTHER|||||||0.0024||95.0||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 100 mg qhs versus placebo||||0.0024
71894361|NCT04112914|143310888|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.606|TWO_SIDED||||||Regression, Linear|||||||0.606
71894362|NCT04112914|143310889|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.508|TWO_SIDED||||||Regression, Linear|||||||0.508
71894363|NCT04112914|143310890|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.042|TWO_SIDED||||||Regression, Linear|||||||0.042
71894364|NCT04112914|143310891|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.128|TWO_SIDED||||||Regression, Linear|||||||0.128
71894365|NCT02580058|143310930|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.8253|TWO_SIDED|95.0|0.867|1.497|||Log Rank|1-sided||||1.497|0.867|0.8253
71894366|NCT02580058|143310930|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.2082|TWO_SIDED|95.0|0.672|1.179|||Log Rank|1-sided||||1.179|0.672|0.2082
71894367|NCT02580058|143310931|SUPERIORITY||Hazard Ratio (HR)|1.68|||>|0.9999|TWO_SIDED|95.0|1.31|2.16|||Log Rank|1-sided||||2.160|1.310|>0.9999
71894368|NCT02580058|143310931|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0301|TWO_SIDED|95.0|0.607|1.011|||Log Rank|1-sided||||1.011|0.607|0.0301
71805099|NCT00360529|143110230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2606||95.0|-1.0|3.7||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||3.7|-1.0|0.2606
71841988|NCT02997202|143194782|SUPERIORITY||Hazard Ratio (HR)|0.8938||||0.641|TWO_SIDED|95.0|0.5574|1.433|||Fine-Grays model|||"aGVHD II to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||1.4330|0.5574|0.6410
71675492|NCT03307252|142868337|OTHER||Adjusted gMean Ratio|428.23|STANDARD_ERROR_OF_MEAN|26.8|||TWO_SIDED|90.0|359.78|509.7|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|509.70|359.78|
71805100|NCT00360529|143110230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.066||95.0|-0.1|4.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||4.6|-0.1|0.066
71805101|NCT00360529|143110231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.1601||95.0|-2.9|0.5||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.5|-2.9|0.1601
71841989|NCT02997202|143194782|SUPERIORITY||Hazard Ratio (HR)|1.4254||||0.4128|TWO_SIDED|95.0|0.6103|3.3289|||Fine-Grays model|||"aGVHD III to IV:~Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate."||3.3289|0.6103|0.4128
71841990|NCT02997202|143194783|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
71841991|NCT02997202|143194784|SUPERIORITY||Hazard Ratio (HR)|1.236||||0.1725|TWO_SIDED|95.0|0.9116|1.6757|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||1.6757|0.9116|0.1725
71841992|NCT02997202|143194785|SUPERIORITY||Hazard Ratio (HR)|3.4537||||0.2029|TWO_SIDED|95.0|0.5126|23.2687|||Fine-Grays Model|||MRD Eradication||23.2687|0.5126|0.2029
71841993|NCT02997202|143194785|SUPERIORITY||Hazard Ratio (HR)|0.7073||||0.4077|TWO_SIDED|95.0|0.3116|1.6055|||Fine-Grays Model|||MRD 10\^-4 Detection||1.6055|0.3116|0.4077
71841994|NCT02997202|143194786|SUPERIORITY||Hazard Ratio (HR)|0.3729|||<|0.001|TWO_SIDED|95.0|0.2243|0.6199|||Fine-Grays Model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||0.6199|0.2243|<0.001
71841995|NCT02997202|143194787|SUPERIORITY||Hazard Ratio (HR)|1.4848||||0.0568|TWO_SIDED|95.0|0.9886|2.23|||Fine-Grays model|||Based on Fine and Gray's model adjusting for conditioning regimen intensity (MAC vs RIC/NMA), time from transplant to randomization (30-60 days vs 61-90 days) \& presence of MRD (present vs absent/indeterminate) based on the pre-transplant BM aspirate.||2.2300|0.9886|0.0568
71841996|NCT00303459|143194796|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.2508|TWO_SIDED|97.31|0.582|1.187|||Log Rank|||||1.187|0.582|0.2508
71841997|NCT00303459|143194797|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.963||||0.8385|TWO_SIDED|95.0|0.673|1.38|||Log Rank|||||1.380|0.673|0.8385
71841998|NCT00303459|143194798|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|21.8||||0.0106|TWO_SIDED|95.0|5.9|37.8|||Wilcoxon (Mann-Whitney)|||||37.8|5.9|0.0106
71841999|NCT00303459|143194799|SUPERIORITY_OR_OTHER_LEGACY||Relative risk of improvement|0.98||||1|TWO_SIDED|95.0|0.6|1.61|||Fisher Exact|||||1.61|0.60|1.0000
71842000|NCT00303459|143194800|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.855||||0.4974|TWO_SIDED|95.0|0.544|1.344|||Log Rank|||||1.344|0.544|0.4974
71842001|NCT00303459|143194801|SUPERIORITY_OR_OTHER_LEGACY||Percentage change over placebo|-23.52||||0.0003|TWO_SIDED|95.0|-33.69|-11.79|||Repeated measures analysis|||||-11.79|-33.69|0.0003
71842002|NCT00303459|143194802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.9566|TWO_SIDED|95.0|-0.42|0.39|||Wilcoxon (Mann-Whitney)|||||0.39|-0.42|0.9566
71842003|NCT00303459|143194803|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.02||||0.5571|TWO_SIDED|95.0|-0.036|0.076|||Wilcoxon (Mann-Whitney)|||||0.076|-0.036|0.5571
71842004|NCT00303459|143194804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.4086|TWO_SIDED|95.0|-3.7|4.0|||Wilcoxon (Mann-Whitney)|||||4.0|-3.7|0.4086
71842005|NCT01570361|143194806|SUPERIORITY|||||||0.0009||||||Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.|Log Rank|One-sided test||||||0.0009
71842006|NCT01570361|143194807|SUPERIORITY|||||||0.0118||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0118
71842007|NCT01570361|143194808|SUPERIORITY|||||||0.0041||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test||||||0.0041
71842008|NCT01116895|143194823|OTHER||Least square mean difference|-2.2||||0.89|TWO_SIDED|95.0|-32.6|28.2|||ANOVA|||||28.2|-32.6|0.89
71842009|NCT01116895|143194823|OTHER||Least square mean difference|4.5||||0.77|TWO_SIDED|95.0|-26.2|35.3|||ANOVA|||||35.3|-26.2|0.77
71842010|NCT01116895|143194823|OTHER||Least square mean difference|-6.7||||0.65|TWO_SIDED|95.0|-36.2|22.8|||ANOVA|||||22.8|-36.2|0.65
71675493|NCT03307252|142868338|OTHER||Adjusted gMean ratio|92.24|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|85.28|99.76|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|99.76|85.28|
71805102|NCT00360529|143110231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9||||0.0001||95.0|-5.6|-2.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-2.2|-5.6|0.0001
71805103|NCT00360529|143110232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1144||95.0|-0.3|0.0||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.0|-0.3|0.1144
71805104|NCT00360529|143110232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0001||95.0|-0.5|-0.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||-0.2|-0.5|0.0001
71805105|NCT00360529|143110233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.0173||95.0|0.0|0.4|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||0.4|0.0|0.0173
71805106|NCT00360529|143110233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.0001||95.0|0.2|0.5|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||0.5|0.2|0.0001
71805107|NCT00360529|143110234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.0071||95.0|0.4|2.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo||2.6|0.4|0.0071
71805108|NCT00360529|143110234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.0001||95.0|1.4|3.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo||3.6|1.4|0.0001
71805109|NCT00360529|143110235|SUPERIORITY_OR_OTHER||Percentage responders|34.7||||0.0513||95.0|29.0|40.4|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 25 mg bid versus placebo||40.4|29.0|0.0513
71805110|NCT00360529|143110235|SUPERIORITY_OR_OTHER||Percentage responders|38.6||||0.0059||95.0|32.6|44.6|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 50 mg qhs versus placebo||44.6|32.6|0.0059
71805111|NCT00932893|143110240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487|||<|0.0001||95.0|0.371|0.638||To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.||0.638|0.371|<0.0001
71805112|NCT00932893|143110241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854||||0.1145||95.0|0.661|1.104||Statistical significance: 1-sided at alpha=0.025|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.||1.104|0.661|0.1145
71805113|NCT00932893|143110243|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.394|||<|0.0001||95.0|2.463|4.676||Statistical significance: 2-sided at alpha=0.025.|Cochran-Mantel-Haenszel|||P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||4.676|2.463|<0.0001
71805114|NCT00932893|143110244|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.502|||<|0.0001||95.0|1.297|1.741||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||1.741|1.297|<0.0001
71805115|NCT00932893|143110245|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.697|||<|0.0001|TWO_SIDED|95.0|1.368|2.103||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.||2.103|1.368|<0.0001
71805116|NCT00932893|143110251|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.497|||<|0.0001||95.0|0.373|0.661|||Log Rank|||The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.||0.661|0.373|<0.0001
71805117|NCT01262651|143110265|SUPERIORITY||Median Difference (Final Values)|3.41||||0.0854|TWO_SIDED|95.0|0.0|8.16|||Wilcoxon (Mann-Whitney)|||||8.16|0.00|0.0854
71805118|NCT04837482|143110280|NON_INFERIORITY|Noninferiority of AGN-190584 was concluded if the lower bound of the 95% CI of the least-square mean difference between AGN-190584 and vehicle was greater than the pre-specified margin of -0.25.|Least-Square (LS) Mean|-0.224|STANDARD_ERROR_OF_MEAN|0.0602||0.0006|TWO_SIDED|95.0|-0.346|-0.103|||Mixed Models Analysis|Linear mixed-effects model with repeated measures||||-0.103|-0.346|0.0006
71813555|NCT04858802|143129476|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|1.24||0.715|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 45||0.2|-0.3|0.715
71813556|NCT04858802|143129476|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|0.96||0.129|TWO_SIDED|95.0|0.0|0.4|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Zinreich's modified Lund-Mackay score for the frontal sinus minus balloon sinus dilation alone mean Zinreich's modified Lund-Mackay score for the frontal sinus|Day 180||0.4|0.0|0.129
71842011|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|0.09|STANDARD_ERROR_OF_MEAN|0.127||0.4641|TWO_SIDED|90.0|-0.12|0.3|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.30|-0.12|0.4641
71842012|NCT02865538|143194883|OTHER|Descriptive Analysis|Linear mixed-effects model|0.0|STANDARD_ERROR_OF_MEAN|0.128||0.9894|TWO_SIDED|90.0|-0.21|0.21|||LS means difference||Change from Week -1 to Week 1|||0.21|-0.21|0.9894
71842013|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|-0.31|STANDARD_ERROR_OF_MEAN|0.129||0.0199|TWO_SIDED|90.0|-0.52|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-0.52|0.0199
71842014|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|-0.12|STANDARD_ERROR_OF_MEAN|0.133||0.3907|TWO_SIDED|90.0|-0.34|0.11|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.11|-0.34|0.3907
71842015|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.166||0.5393|TWO_SIDED|90.0|-0.17|0.38|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.38|-0.17|0.5393
71842016|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|-0.04|STANDARD_ERROR_OF_MEAN|0.169||0.7931|TWO_SIDED|90.0|-0.33|0.24|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.24|-0.33|0.7931
71842017|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|-0.63|STANDARD_ERROR_OF_MEAN|0.169||0.0004|TWO_SIDED|90.0|-0.92|-0.35|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.35|-0.92|0.0004
71842018|NCT02865538|143194883|OTHER|Descriptive Analysis|LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.175||0.3739|TWO_SIDED|90.0|-0.45|0.13|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.13|-0.45|0.3739
71894369|NCT02580058|143310950|OTHER||Geometric Mean Ratio (Test/Reference, %)|110.0|||||TWO_SIDED|90.0|95.4|126.7||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||126.7|95.4|
71675494|NCT03307252|142868338|OTHER||Adjusted gMean Ratio|83.99|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|78.32|90.08|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|90.08|78.32|
71894370|NCT02580058|143310951|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|79.5|101.5||||||Avelumab was the Reference treatment and Avelumab + PLD was the Test treatment||101.5|79.5|
71894371|NCT02580058|143310952|OTHER||Geometric Mean Ratio (Test/Reference, %)|96.0|||||TWO_SIDED|90.0|87.0|106.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||106|87|
71675495|NCT03307252|142868338|OTHER||Adjusted gMean Ratio|124.06|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|105.11|146.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|146.43|105.11|
71675496|NCT03307252|142868339|OTHER||Adjusted gMean Ratio|112.73|STANDARD_ERROR_OF_MEAN|11.2|||TWO_SIDED|90.0|104.23|121.92|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|121.92|104.23|
71842019|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|5.29|STANDARD_ERROR_OF_MEAN|3.077||0.09|TWO_SIDED|90.0|0.16|10.42|||Linear mixed-effects model||Change from Week -1 to Week 1|||10.42|0.16|0.0900
71842020|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|-4.46|STANDARD_ERROR_OF_MEAN|3.053||0.1487|TWO_SIDED|90.0|-9.55|0.63|||Linear mixed-effects model||Change from Week -1 to Week 1|||0.63|-9.55|0.1487
71842021|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|-10.18|STANDARD_ERROR_OF_MEAN|3.015||0.0012|TWO_SIDED|90.0|-15.2|-5.15|||Linear mixed-effects model||Change from Week -1 to Week 1|||-5.15|-15.20|0.0012
71842022|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|-6.14|STANDARD_ERROR_OF_MEAN|3.142||0.0548|TWO_SIDED|90.0|-11.37|-0.9|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.90|-11.37|0.0548
71842023|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|6.59|STANDARD_ERROR_OF_MEAN|3.337||0.0522|TWO_SIDED|90.0|1.03|12.15|||Linear mixed-effects model||Change from Week -1 to Week 2|||12.15|1.03|0.0522
71842024|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|-5.07|STANDARD_ERROR_OF_MEAN|3.329||0.1326|TWO_SIDED|90.0|-10.61|0.48|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.48|-10.61|0.1326
71842025|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|-12.28|STANDARD_ERROR_OF_MEAN|3.27||0.0004|TWO_SIDED|90.0|-17.73|-6.83|||Linear mixed-effects model||Change from Week -1 to Week 2|||-6.83|-17.73|0.0004
71842026|NCT02865538|143194884|OTHER|Descriptive Analysis|LS means difference|-7.79|STANDARD_ERROR_OF_MEAN|3.408||0.0253|TWO_SIDED|90.0|-13.47|-2.11|||Linear mixed-effects model||Change from Week -1 to Week 2|||-2.11|-13.47|0.0253
71842027|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|1.4|STANDARD_ERROR_OF_MEAN|1.58||0.3796|TWO_SIDED|90.0|-1.2|4.0|||Linear mixed-effects model||Day 7 Change from Day -1|||4.0|-1.2|0.3796
71842028|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|-2.3|STANDARD_ERROR_OF_MEAN|1.55||0.1413|TWO_SIDED|90.0|-4.9|0.3|||Linear mixed-effects model||Day 7 Change from Day -1|||0.3|-4.9|0.1413
71842029|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|1.55||0.0007|TWO_SIDED|90.0|-8.1|-2.9|||Linear mixed-effects model||Day 7 Change from Day -1|||-2.9|-8.1|0.0007
71842030|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.62||0.0624|TWO_SIDED|90.0|-5.8|-0.4|||Linear mixed-effects model||Day 7 Change from Day -1|||-0.4|-5.8|0.0624
71894372|NCT02580058|143310953|OTHER||Geometric Mean Ratio (Test/Reference, %)|95.0|||||TWO_SIDED|90.0|88.0|104.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||104|88|
71894373|NCT02580058|143310954|OTHER||Geometric Mean Ratio (Test/Reference, %)|90.0|||||TWO_SIDED|90.0|76.0|107.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||107|76|
71805119|NCT00407537|143110302|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.72|||<|0.001|TWO_SIDED|95.0|-5.55|-3.89||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.||-3.89|-5.55|<0.001
71805120|NCT00407537|143110303|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-4.76|||<|0.001|TWO_SIDED|95.0|-5.58|-3.93||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-3.93|-5.58|<0.001
71805121|NCT00407537|143110304|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.97|||<|0.001|TWO_SIDED|95.0|-1.23|-0.72||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.72|-1.23|<0.001
71805122|NCT00407537|143110305|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.16|-0.59||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-0.59|-1.16|<0.001
71805123|NCT00407537|143110306|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.56|-1.15||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.15|-1.56|<0.001
71805124|NCT00407537|143110307|SUPERIORITY_OR_OTHER_LEGACY||LSMean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.57|-1.14||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|||-1.14|-1.57|<0.001
71805125|NCT00407537|143110312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.15|||<|0.007|TWO_SIDED|95.0|-5.42|-0.88|||Mixed-effect linear model|||||-0.88|-5.42|<0.007
71805126|NCT00407537|143110313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.61|||<|0.011|TWO_SIDED|95.0|-2.86|-0.37|||Mixed-effect linear model|||||-0.37|-2.86|<0.011
71805127|NCT00407537|143110314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.75|||<|0.001|TWO_SIDED|95.0|-8.0|-3.5|||Mixed-effect linear model|||||-3.50|-8.00|<0.001
71842031|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|1.3|STANDARD_ERROR_OF_MEAN|1.21||0.293|TWO_SIDED|90.0|-0.7|3.3|||Linear mixed-effects model||Day 14 Change from Day -1|||3.3|-0.7|0.2930
71842032|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.21||0.0512|TWO_SIDED|90.0|-4.4|-0.4|||Linear mixed-effects model||Day 14 Change from Day -1|||-0.4|-4.4|0.0512
71842033|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|90.0|-7.0|-3.0|||Linear mixed-effects model||Day 14 Change from Day -1|||-3.0|-7.0|<0.0001
71842034|NCT02865538|143194885|OTHER|Descriptive Analysis|LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.25||0.008|TWO_SIDED|90.0|-5.5|-1.3|||Linear mixed-effects model||Day 14 Change from Day -1|||-1.3|-5.5|0.0080
71842035|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|0.84|STANDARD_ERROR_OF_MEAN|0.574||0.1482|TWO_SIDED|90.0|-0.12|1.8|||Linear mixed-effects model||Change from Week -1 to Week 1|||1.80|-0.12|0.1482
71842036|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|-1.04|STANDARD_ERROR_OF_MEAN|0.571||0.0734|TWO_SIDED|90.0|-1.99|-0.09|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.09|-1.99|0.0734
71894374|NCT02580058|143310955|OTHER||Geometric Mean Ratio (Test/Reference, %)|100.0|||||TWO_SIDED|90.0|60.0|168.0||||||PLD was the Reference treatment and Avelumab + PLD was the Test treatment.||168|60|
71894375|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-2.0|||||TWO_SIDED|95.0|-7.65|2.88||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||2.88|-7.65|
71894376|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-14.9|||||TWO_SIDED|95.0|-26.4|-3.21||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.21|-26.40|
71894377|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|0.06|||||TWO_SIDED|95.0|-5.84|6.05||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.05|-5.84|
71894378|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|2.06|||||TWO_SIDED|95.0|-1.71|7.25||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||7.25|-1.71|
71842037|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.565||0.0022|TWO_SIDED|90.0|-2.74|-0.86|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.86|-2.74|0.0022
71675497|NCT03307252|142868339|OTHER||Adjusted gMean Ratio|108.56|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|101.22|116.43|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|116.43|101.22|
71675498|NCT03307252|142868339|OTHER||Adjusted gMean Ratio|340.67|STANDARD_ERROR_OF_MEAN|23.9|||TWO_SIDED|90.0|288.63|402.1|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|402.10|288.63|
71805128|NCT00407537|143110315|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.42|-1.92|||Mixed-effect linear model|||||-1.92|-4.42|<0.001
71805129|NCT00407537|143110316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
71805130|NCT00407537|143110316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
71805131|NCT00407537|143110316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||2.13|-0.14|0.087
71813557|NCT04858802|143129477|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.28|3.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 21||3.60|0.28|1.00
71813558|NCT04858802|143129477|SUPERIORITY||Odds Ratio (OR)|0.79||||0.453|TWO_SIDED|95.0|0.36|1.73||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45||1.73|0.36|0.453
71813559|NCT04858802|143129477|SUPERIORITY||Odds Ratio (OR)|0.71||||0.219|TWO_SIDED|95.0|0.31|1.61||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 90||1.61|0.31|0.219
71813560|NCT04858802|143129477|SUPERIORITY||Odds Ratio (OR)|0.71||||0.289|TWO_SIDED|95.0|0.31|1.61|||t-test, 2 sided|||Day 180||1.61|0.31|0.289
71813561|NCT04858802|143129478|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|21.12||0.971|TWO_SIDED|95.0|-4.9|4.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|Day 180||4.8|-4.9|0.971
71813562|NCT04858802|143129479|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.56||1|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided|||Day 45|Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|0.1|-0.1|1.00
71813563|NCT04858802|143129479|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.42||0.288|TWO_SIDED|95.0|0.0|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|0.0|0.288
71813564|NCT04858802|143129480|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.64||0.225|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 45 minus balloon sinus dilation alone mean Lund-Mackay score for the frontal sinus at Day 45|Day 45||0.1|-0.2|0.225
71813565|NCT04858802|143129480|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.65||0.388|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean Lund-Mackay score for the frontal sinus at Day 180 minus balloon sinus dilation alone modified Lund-Mackay score for the frontal sinus at Day 180|Day 180||0.1|-0.2|0.388
71813566|NCT04858802|143129481|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.68||0.537|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 21||0.1|-0.2|0.537
71813567|NCT04858802|143129481|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_DEVIATION|0.54||0.01|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 45||0.0|-0.3|0.010
71813568|NCT04858802|143129481|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.7||0.003|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.003
71813569|NCT04858802|143129481|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.66||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the frontal recess/FSO minus balloon sinus dilation alone mean adhesion/scarring grade in the frontal recess/FSO|Day 180||-0.1|-0.4|0.007
71675499|NCT03307252|142868340|OTHER||Adjusted gMean ratio|100.78|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|90.0|93.59|108.51|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|108.51|93.59|
71675500|NCT03307252|142868340|OTHER||Adjusted gMean Ratio|131.37|STANDARD_ERROR_OF_MEAN|13.4|||TWO_SIDED|90.0|120.37|143.37|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|143.37|120.37|
71675501|NCT03307252|142868340|OTHER||Adjusted gMean Ratio|106.55|STANDARD_ERROR_OF_MEAN|12.8|||TWO_SIDED|90.0|96.87|117.19|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|117.19|96.87|
71675502|NCT03307252|142868341|OTHER||Adjusted gMean ratio|260.11|STANDARD_ERROR_OF_MEAN|14.7|||TWO_SIDED|90.0|237.96|284.32|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|284.32|237.96|
71675503|NCT03307252|142868341|OTHER||Adjusted gMean Ratio|101.21|STANDARD_ERROR_OF_MEAN|9.4|||TWO_SIDED|90.0|95.15|107.66|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|107.66|95.15|
71675504|NCT03307252|142868341|OTHER||Adjusted gMean Ratio|215.28|STANDARD_ERROR_OF_MEAN|13.1|||TWO_SIDED|90.0|197.53|234.63|||ANOVA||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|234.63|197.53|
71675505|NCT03482453|142868346|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.881|||||TWO_SIDED|90.0|0.7108|1.0921||||||||1.0921|0.7108|
71805132|NCT00407537|143110316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effects linear model|||Triglycerides||-14.70|-32.60|<0.001
71675506|NCT03482453|142868346|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9637|||||TWO_SIDED|90.0|0.8361|1.1107||||||||1.1107|0.8361|
71805133|NCT00407537|143110317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-28.56|-37.57|<0.001
71842038|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.589||0.066|TWO_SIDED|90.0|-2.08|-0.12|||Linear mixed-effects model||Change from Week -1 to Week 1|||-0.12|-2.08|0.0660
71842039|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|1.18|STANDARD_ERROR_OF_MEAN|0.613||0.0593|TWO_SIDED|90.0|0.15|2.2|||Linear mixed-effects model||||Change from Week -1 to Week 2|2.20|0.15|0.0593
71842040|NCT02865538|143194886|OTHER||LS means difference|-0.93|STANDARD_ERROR_OF_MEAN|0.614||0.1354|TWO_SIDED|90.0|-1.95|0.1|||Linear mixed-effects model||Change from Week -1 to Week 2|||0.10|-1.95|0.1354
71842041|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.603||0.0005|TWO_SIDED|90.0|-3.21|-1.2|||Linear mixed-effects model||Change from Week -1 to Week 2|||-1.20|-3.21|0.0005
71842042|NCT02865538|143194886|OTHER|Descriptive Analysis|LS means difference|-1.38|STANDARD_ERROR_OF_MEAN|0.628||0.0309|TWO_SIDED|90.0|-2.43|-0.34|||Linear mixed-effects model||Change from Week -1 to Week 2|||-0.34|-2.43|0.0309
71842043|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-9.7|STANDARD_ERROR_OF_MEAN|10.88||0.3768|TWO_SIDED|90.0|-27.8|8.5|||Linear mixed-effects model||Change from Day -1 to Day 1|||8.5|-27.8|0.3768
71842044|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-25.0|STANDARD_ERROR_OF_MEAN|10.89||0.0248|TWO_SIDED|90.0|-43.1|-6.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-6.8|-43.1|0.0248
71842045|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-43.9|STANDARD_ERROR_OF_MEAN|10.9||0.0001|TWO_SIDED|90.0|-62.1|-25.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-25.8|-62.1|0.0001
71842046|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-42.9|STANDARD_ERROR_OF_MEAN|11.43||0.0004|TWO_SIDED|90.0|-61.9|-23.8|||Linear mixed-effects model||Change from Day -1 to Day 1|||-23.8|-61.9|0.0004
71842047|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|10.4|STANDARD_ERROR_OF_MEAN|14.76||0.4819|TWO_SIDED|90.0|-14.2|35.1|||Linear mixed-effects model||Change from Day -1 to Day 7|||35.1|-14.2|0.4819
71842048|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|14.77||0.8694|TWO_SIDED|90.0|-27.1|22.2|||Linear mixed-effects model||Change from Day -1 to Day 7|||22.2|-27.1|0.8694
71842049|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-23.9|STANDARD_ERROR_OF_MEAN|14.79||0.1105|TWO_SIDED|90.0|-48.6|0.7|||Linear mixed-effects model||Change from Day -1 to Day 7|||0.7|-48.6|0.1105
71842050|NCT02865538|143194887|OTHER|Descriptive analysis|LS means difference|-18.4|STANDARD_ERROR_OF_MEAN|15.5||0.239|TWO_SIDED|90.0|-44.2|7.4|||Linear mixed-effects model||Change from Day -1 to Day 7|||7.4|-44.2|0.2390
71675507|NCT03482453|142868347|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9317|||||TWO_SIDED|90.0|0.8458|1.0263||||||||1.0263|0.8458|
71805134|NCT00407537|143110317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
71805135|NCT00407537|143110317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL||1.86|-0.71|0.379
71805136|NCT00407537|143110317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
71805137|NCT00407537|143110318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.94|||<|0.001|TWO_SIDED|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC||-34.17|-43.71|<0.001
71805138|NCT00407537|143110318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.31|||<|0.001|TWO_SIDED|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-30.99|-39.64|<0.001
71842051|NCT03106740|143194888|SUPERIORITY|Because relevant \[11C\]PBR28 PET imaging data were unavailable at the time of trial initiation to inform a power analysis of a treatment effect, we ran a power analysis of the treatment effect on the expected change in pain ratings based on a recent clinical trial using minocycline in subjects with back pain. We computed the sample size required for mixed effects between-subject and within-subject (Time: Pretest/Posttest) repeated measures ANOVA design. Alpha was set at 0.05 (two-tailed test).|Restricted maximum likelihood|0.0||||0.956|TWO_SIDED|95.0|-0.02|0.02||The p-value corresponds to the group-by-time interaction analysis of the primary outcome measure.|Mixed Models Analysis||Estimation parameter: Unstandardized partial regression coefficient (beta)|||0.02|-0.02|0.956
71842052|NCT04797858|143194896|SUPERIORITY||Risk Difference (RD)|0.0077||||0.45|TWO_SIDED|95.0|-0.021|0.056|||Fisher Exact|||||0.056|-0.021|0.45
71842053|NCT04797858|143194897|SUPERIORITY||Risk Difference (RD)|0.015||||0.11|TWO_SIDED|95.0|-0.0004|0.03|||Fisher Exact|||||0.03|-0.0004|0.11
71842054|NCT05423730|143194912|SUPERIORITY||Mean Difference (Final Values)|-11.12|||||TWO_SIDED|95.0|-49.75|57.2|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||57.20|-49.75|
71805139|NCT00407537|143110318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.99||||0.087|TWO_SIDED|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||2.13|-0.14|0.087
71842055|NCT05423730|143194913|SUPERIORITY||Mean Difference (Final Values)|7.65|||||TWO_SIDED|95.0|-47.96|63.9|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||63.90|-47.96|
71842056|NCT05423730|143194914|SUPERIORITY||Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.95|0.67|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||0.67|-1.95|
71805140|NCT00407537|143110318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.65|||<|0.001|TWO_SIDED|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-14.70|-32.60|<0.001
71842057|NCT05423730|143194915|SUPERIORITY||Mean Difference (Final Values)|13.83|||||TWO_SIDED|95.0|-9.45|43.09|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||43.09|-9.45|
71805141|NCT00407537|143110319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-33.07|||<|0.001|TWO_SIDED|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Total cholesterol||-28.56|-37.57|<0.001
71894379|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|2.12|||||TWO_SIDED|95.0|-4.09|8.89||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||8.89|-4.09|
71894380|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
71675508|NCT03482453|142868352|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|1.0153|||||TWO_SIDED|90.0|0.8977|1.1483||||||||1.1483|0.8977|
71675509|NCT03482453|142868352|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9506|||||TWO_SIDED|90.0|0.874|1.0339||||||||1.0339|0.8740|
71805142|NCT00407537|143110319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.83|||<|0.001|TWO_SIDED|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL||-25.95|-33.70|<0.001
71805143|NCT00407537|143110319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58||||0.379|TWO_SIDED|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL||1.86|-0.71|0.379
71805144|NCT00407537|143110319|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.001|TWO_SIDED|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides||-7.81|-28.72|<0.001
71805145|NCT00782340|143110344|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.003
71805146|NCT00782340|143110345|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.||||||0.003
71805147|NCT00782340|143110346|SUPERIORITY_OR_OTHER|||||||0.01||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.010
71805148|NCT00782340|143110347|SUPERIORITY_OR_OTHER|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.003
71805149|NCT00782340|143110348|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.||||||0.009
71805150|NCT00782340|143110349|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||<0.001
71805151|NCT00782340|143110350|SUPERIORITY_OR_OTHER|||||||0.327||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.|Fisher Exact|||||||0.327
71805152|NCT02219932|143110358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.006|TWO_SIDED|95.0|1.15|2.26|||Regression, Logistic||fampridine vs. placebo|Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||2.26|1.15|0.006
71805153|NCT02219932|143110358|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.104|||||TWO_SIDED|95.0|0.03|0.178||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||0.178|0.030|
71805154|NCT02219932|143110358|SUPERIORITY_OR_OTHER||Relative Risk|1.38|||||TWO_SIDED|95.0|1.06|1.7||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.||1.70|1.06|
71805155|NCT02219932|143110359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.04|2.07|||Regression, Logistic|||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||2.07|1.04|0.030
71805156|NCT02219932|143110359|SUPERIORITY_OR_OTHER||Risk Difference for Adjusted Proportions|0.092|||||TWO_SIDED|95.0|0.009|0.175||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||0.175|0.009|
71805157|NCT02219932|143110359|SUPERIORITY_OR_OTHER||Relative Risk|1.25|||||TWO_SIDED|95.0|0.99|1.51||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.||1.51|0.99|
71675510|NCT03482453|142868353|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9603|||||TWO_SIDED|90.0|0.8861|1.0408||||||||1.0408|0.8861|
71675511|NCT02157376|142868376|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the two-sided 95% confidence interval for the difference is larger than -0.05, the non-inferiority claim will be met.|Risk Difference (RD)|1.9||||0.393|TWO_SIDED|95.0|-2.8|6.5|||Pearson's Chi-square||The difference in treatment group percentages is given by Cimetidine minus Esomeprazole.|Assuming a bleeding percent of 6.3% for the active comparator, a risk reduction of 3.7% for esomeprazole, and a 5% non-inferiority margin, 150 patients per treatment arm will provide 94% power to demonstrate non-inferiority. The null hypothesis is that the bleeding rate for iv esomeprazole 40 mg bid exceeds the rate for iv cimetidine by an amount at least as large as 5%.||6.5|-2.8|0.393
71675512|NCT01578239|142868395|SUPERIORITY||Hazard Ratio (HR)|0.177|||<|0.0001|TWO_SIDED|95.0|0.108|0.289||Derived from a two-sided test between the two groups|Log Rank||Hazard ratio is expressed as Lu-DOTA-Tyr-Octreotate / Octreotide LAR and estimated from the corresponding Cox model.|||0.289|0.108|<0.0001
71805158|NCT02219932|143110360|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.31|STANDARD_ERROR_OF_MEAN|0.925|<|0.001|TWO_SIDED|95.0|-5.13|-1.5|||mixed model for repeated measures|||||-1.50|-5.13|< 0.001
71805159|NCT02219932|143110361|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.277||0.141|TWO_SIDED|95.0|-0.13|0.95|||mixed model for repeated measures|||||0.95|-0.13|0.141
71805160|NCT02219932|143110362|SUPERIORITY_OR_OTHER||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.573||0.197|TWO_SIDED|95.0|-0.38|1.86|||mixed model for repeated measures|||||1.86|-0.38|0.197
71805161|NCT01866410|143110369|OTHER|||||||0.4|||||||Log Rank|||||||0.4
71805162|NCT01866410|143110370|OTHER|||||||0.5|||||||Log Rank|||||||0.5
71805163|NCT00968669|143110395|SUPERIORITY_OR_OTHER|||||||0.435|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.435
71842058|NCT05423730|143194916|SUPERIORITY||Mean Difference (Final Values)|11.42|||||TWO_SIDED|95.0|-3.31|28.4|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||28.40|-3.31|
71842059|NCT05423730|143194917|SUPERIORITY||Mean Difference (Final Values)|12.57|||||TWO_SIDED|95.0|-0.77|27.69|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||27.69|-0.77|
71842060|NCT05423730|143194918|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-21.92|21.24|||||Estimates represent percentage change in log-transformed hormone levels for wine versus grape juice from linear mixed models including participant as a random effect and interaction terms for drink and sequence (Kenward approach).|||21.24|-21.92|
71842061|NCT05363163|143194924|OTHER|If the mean volume variation was higher than 0 and the p-value of the statistical test lower than 0.05, the H0 hypothesis was rejected, and the primary endpoint demonstrated.|||||<|0.0001||||||p-value of the statistical test lower than 0.05|t-test, 2 sided|||||||<0.0001
71805164|NCT00968669|143110395|SUPERIORITY_OR_OTHER|||||||0.828|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.828
71805165|NCT00968669|143110395|SUPERIORITY_OR_OTHER|||||||0.628|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward||||||0.628
71675513|NCT01578239|142868396|SUPERIORITY|||||||0.0141|||||||Fisher Exact|||||||0.0141
71675514|NCT01578239|142868397|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank|||||1.17|0.60|0.3039
71805166|NCT00968669|143110396|SUPERIORITY_OR_OTHER|||||||0.271|||||||Pairwise Poisson Regression|||||||0.271
71805167|NCT00968669|143110396|SUPERIORITY_OR_OTHER|||||||0.319|||||||Pairwise Poisson Regression|||||||0.319
71675515|NCT01578239|142868398|SUPERIORITY||Cox Proportional Hazard|0.84||||0.3039|TWO_SIDED|95.0|0.6|1.17|||Log Rank||Hazard Ratio of Lu-DOTA-Tyr-Octreotate vs. Octreotide LAR|||1.17|0.60|0.3039
71805168|NCT00968669|143110396|SUPERIORITY_OR_OTHER|||||||0.502|||||||Pairwise Poisson Regression|||||||0.502
71805169|NCT00968669|143110397|SUPERIORITY_OR_OTHER|||||||0.756|||||||Pairwise Poisson Regression|||||||0.756
71805170|NCT00968669|143110397|SUPERIORITY_OR_OTHER|||||||0.047|||||||Pairwise Poisson Regression|||||||0.047
71805171|NCT00968669|143110397|SUPERIORITY_OR_OTHER|||||||1|||||||Pairwise Poisson Regression|||||||1.000
71805172|NCT00968669|143110398|SUPERIORITY_OR_OTHER|||||||0.1764|||||||Fisher Exact|||||||0.1764
71805173|NCT00968669|143110398|SUPERIORITY_OR_OTHER|||||||0.4031|||||||Fisher Exact|||||||0.4031
71805174|NCT00968669|143110398|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71805175|NCT00968669|143110399|SUPERIORITY_OR_OTHER|||||||0.8475|||||||Fisher Exact|||||||0.8475
71805176|NCT00968669|143110399|SUPERIORITY_OR_OTHER|||||||0.0811|||||||Fisher Exact|||||||0.0811
71805177|NCT00968669|143110399|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71805178|NCT00968669|143110400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.938||||0.144|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.144
71805179|NCT00968669|143110400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.395|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.395
71805180|NCT00968669|143110400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.863|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.863
71805181|NCT00968669|143110401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162||||0.717|||||||Log Rank|Stratified by atopic asthma and steroid use||||||0.717
71805182|NCT00968669|143110401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.467||||0.07|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.070
71805183|NCT00968669|143110401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.934|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.934
71805184|NCT00968669|143110402|SUPERIORITY_OR_OTHER|||||||0.813|||||||ANOVA|||||||0.813
71842062|NCT02056834|143195004|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.0166
71675516|NCT01578239|142868399|SUPERIORITY||Hazard Ratio (HR)|0.137|||<|0.0001|TWO_SIDED|95.0|0.077|0.242|||Log Rank|||||0.242|0.077|<0.0001
71805185|NCT00968669|143110402|SUPERIORITY_OR_OTHER|||||||0.29|||||||ANOVA|||||||0.290
71805186|NCT00968669|143110402|SUPERIORITY_OR_OTHER|||||||0.303|||||||ANOVA|||||||0.303
71805187|NCT00968669|143110403|SUPERIORITY_OR_OTHER|||||||0.764|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.764
71805188|NCT00968669|143110404|SUPERIORITY_OR_OTHER|||||||0.986|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo||||0.986
71805189|NCT00968669|143110405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.955||||0.7171|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7171
71805190|NCT00968669|143110405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.6219|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6219
71805191|NCT00968669|143110405|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.909||||0.6182|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.6182
71805192|NCT00968669|143110406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.952||||0.712|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.7120
71805193|NCT00968669|143110406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.928||||0.5086|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5086
71805194|NCT00968669|143110406|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.887||||0.5184|||||||Log Rank|Stratified by atopic asthma status and steroid use||||||0.5184
71805195|NCT00968669|143110407|SUPERIORITY_OR_OTHER|||||||0.837|||||||Two-sample t-test|||||||0.837
71805196|NCT00968669|143110407|SUPERIORITY_OR_OTHER|||||||0.756|||||||Two-sample t-test|||||||0.756
71805197|NCT00968669|143110407|SUPERIORITY_OR_OTHER|||||||0.224|||||||Two-sample t-test|||||||0.224
71805198|NCT00968669|143110408|SUPERIORITY_OR_OTHER|||||||0.409|||||||Two-sample t-test|||||||0.409
71805199|NCT00968669|143110408|SUPERIORITY_OR_OTHER|||||||0.847|||||||Two-sample t-test|||||||0.847
71842063|NCT02056834|143195005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.||||0.3785
71675517|NCT02347813|142868410|OTHER||Mean Difference (Final Values)|0.5||||0.75|TWO_SIDED|95.0|||||ANOVA|||||||0.750
71805200|NCT00968669|143110408|SUPERIORITY_OR_OTHER|||||||0.968|||||||Two-sample t-test|||||||0.968
71805201|NCT00968669|143110409|SUPERIORITY_OR_OTHER|||||||0.208|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.208
71805202|NCT00968669|143110410|SUPERIORITY_OR_OTHER|||||||0.574|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo||||0.574
71805203|NCT00144339|143110416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|2.0||0.9524||95.0|-4.0|4.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-4|0.9524
71675518|NCT01385137|142868415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.58|TWO_SIDED|95.0|-0.79|0.44|||Regression, Linear|||||0.44|-0.79|0.58
71805204|NCT00144339|143110417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.2074||95.0|-2.0|6.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||6|-2|0.2074
71805205|NCT00144339|143110418|SUPERIORITY_OR_OTHER|||||||0.2488||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2488
71805206|NCT00144339|143110419|SUPERIORITY_OR_OTHER|||||||0.0145||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.0145
71805207|NCT00144339|143110420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.0||0.299||95.0|-12.0|4.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||4|-12|0.2990
71805208|NCT00144339|143110421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.8375||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.8375
71805209|NCT00144339|143110422|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|4.0||0.1143||95.0|-14.0|2.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||2|-14|0.1143
71805210|NCT00144339|143110423|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|4.0||0.787||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||7|-9|0.7870
71805211|NCT00144339|143110424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.784||95.0|-0.2|0.3|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model||0.3|-0.2|0.7840
71805212|NCT00144339|143110425|SUPERIORITY_OR_OTHER|||||||0.2705||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.2705
71805213|NCT00144339|143110426|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.306
71805214|NCT00144339|143110427|SUPERIORITY_OR_OTHER|||||||0.8103||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.8103
71675519|NCT01385137|142868417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.42|TWO_SIDED|95.0|-7.3|3.04|||Regression, Linear|||||3.04|-7.30|0.42
71805215|NCT00144339|143110428|SUPERIORITY_OR_OTHER|||||||0.9814||95.0|||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between||||||0.9814
71675520|NCT01385137|142868418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.77|TWO_SIDED|95.0|-4.17|5.6|||Regression, Linear|||||5.60|-4.17|0.77
71805216|NCT00144339|143110429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||Log Rank|Cox regression with treatment|Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo|Cox regression||0.91|0.81|<0.0001
71805217|NCT00144339|143110430|SUPERIORITY_OR_OTHER||Rate Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.81|0.91|||t-test, 2 sided||Ratio calculated as estimated number of events in tio/number of events in placebo|Poisson regression adjusted for overdispersion and treatment exposure||0.91|0.81|<0.0001
71805218|NCT00144339|143110431|SUPERIORITY_OR_OTHER|||||||0.3481||95.0|||||Fisher Exact|||||||0.3481
71805219|NCT00144339|143110432|SUPERIORITY_OR_OTHER||Rate Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.03||0.0011||95.0|0.83|0.95|||t-test, 2 sided||Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|Poisson regression adjusted for overdispersion and treatment exposure||0.95|0.83|0.0011
71805220|NCT00144339|143110433|SUPERIORITY_OR_OTHER|||||||0.1766||95.0|||||Fisher Exact|||||||0.1766
71805221|NCT00144339|143110434|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|STANDARD_ERROR_OF_MEAN|0.04||0.0024||95.0|0.78|0.95|||Log Rank||Hazard ratio shown as tiotropium bromide vs. placebo|Cox regression||0.95|0.78|0.0024
71805222|NCT00144339|143110435|SUPERIORITY_OR_OTHER||Rate ratio|0.94|STANDARD_ERROR_OF_MEAN|0.06||0.3413||95.0|0.82|1.07|||t-test, 2 sided||Ratio of estimated number of events between tiotropium bromide and placebo|||1.07|0.82|0.3413
71805223|NCT00144339|143110436|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.8624||95.0|0.87|1.18|||t-test, 2 sided||Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo|Poisson regression adjusting for overdispersion with Pearson's method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.||1.18|0.87|0.8624
71805224|NCT00144339|143110437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|||<|0.0001||95.0|0.077|0.098|||ANOVA|Repeated measures ANOVA||||0.098|0.077|<.0001
71805225|NCT00144339|143110438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|||<|0.0001||95.0|0.037|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.037|<.0001
71842064|NCT02056834|143195006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
71894381|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-6.92|||||TWO_SIDED|95.0|-16.19|1.89||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.89|-16.19|
71675521|NCT01385137|142868419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.21|TWO_SIDED|95.0|-1.16|5.44|||Regression, Linear|||||5.44|-1.16|0.21
71805226|NCT00144339|143110439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.087|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.087|<.0001
71805227|NCT00144339|143110440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|||<|0.0001||95.0|0.047|0.069|||ANOVA|Repeated measures ANOVA||||0.069|0.047|<.0001
71805228|NCT00144339|143110441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|||<|0.0001||95.0|0.091|0.115|||ANOVA|Repeated measures ANOVA||||0.115|0.091|<.0001
71805229|NCT00144339|143110442|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.054|||<|0.0001||95.0|0.042|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.042|<.0001
71805230|NCT00144339|143110443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|||<|0.0001||95.0|0.078|0.104|||ANOVA|Repeated measures ANOVA||||0.104|0.078|<.0001
71805231|NCT00144339|143110444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|||<|0.0001||95.0|0.04|0.066|||ANOVA|Repeated measures ANOVA||||0.066|0.040|<.0001
71805232|NCT00144339|143110445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.0001||95.0|0.081|0.107|||ANOVA|Repeated measures ANOVA||||0.107|0.081|<.0001
71805233|NCT00144339|143110446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|||<|0.0001||95.0|0.049|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.049|<.0001
71805234|NCT00144339|143110447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.081|0.109|||ANOVA|Repeated measures ANOVA||||0.109|0.081|<.0001
71805235|NCT00144339|143110448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.047|0.075|||ANOVA|Repeated measures ANOVA||||0.075|0.047|<.0001
71805236|NCT00144339|143110449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.085|0.114|||ANOVA|Repeated measures ANOVA||||0.114|0.085|<.0001
71805237|NCT00144339|143110450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.051|0.08|||ANOVA|Repeated measures ANOVA||||0.080|0.051|<.0001
71805238|NCT00144339|143110451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.08|0.11|||ANOVA|Repeated measures ANOVA||||0.110|0.080|<.0001
71805239|NCT00144339|143110452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.045|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.045|<.0001
71805240|NCT00144339|143110453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.0001||95.0|0.073|0.103|||ANOVA|Repeated measures ANOVA||||0.103|0.073|<.0001
71805241|NCT00144339|143110454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||<|0.0001||95.0|0.033|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.033|<.0001
71805242|NCT00144339|143110455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|||<|0.0001||95.0|0.168|0.211|||ANOVA|Repeated measures ANOVA||||0.211|0.168|<.0001
71805243|NCT00144339|143110456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.037|0.073|||ANOVA|Repeated measures ANOVA||||0.073|0.037|<.0001
71805244|NCT00144339|143110457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|||<|0.0001||95.0|0.18|0.228|||ANOVA|Repeated measures ANOVA||||0.228|0.180|<.0001
71842065|NCT02056834|143195007|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.||||<0.0001
71842066|NCT06193070|143195021|OTHER|A one-tailed paired t-test was run to examine within subject mean difference on the cancer nutrition information beliefs scale pre- and post-game.|||||<|0.001||||||The threshold was set at alpha \< 0.05.|t-test, 1 sided|A paired samples t-test was run on pre- and post-game mean scores within subjects.||All participants were exposed to the intervention, and pre- and post-game scores within subject were examined.||||<.001
71894382|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-1.94|||||TWO_SIDED|95.0|-9.07|4.86||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.86|-9.07|
71675522|NCT02837731|142868420|SUPERIORITY||Mean Difference (Final Values)|-1.37||||0.021|TWO_SIDED|95.0|-2.53|0.21|||t-test, 2 sided|||||0.21|-2.53|0.021
71805245|NCT00144339|143110458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.034|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.034|<.0001
71805246|NCT00144339|143110459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|||<|0.0001||95.0|0.173|0.222|||ANOVA|Repeated measures ANOVA||||0.222|0.173|<.0001
71805247|NCT00144339|143110460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||<|0.0001||95.0|0.026|0.07|||ANOVA|Repeated measures ANOVA||||0.070|0.026|<.0001
71805248|NCT00144339|143110461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.194|||<|0.0001||95.0|0.167|0.221|||ANOVA|Repeated measures ANOVA||||0.221|0.167|<.0001
71805249|NCT00144339|143110462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||<|0.0001||95.0|0.026|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.026|<.0001
71805250|NCT00144339|143110463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|||<|0.0001||95.0|0.161|0.216|||ANOVA|Repeated measures ANOVA||||0.216|0.161|<.0001
71805251|NCT00144339|143110464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|||<|0.0001||95.0|0.035|0.084|||ANOVA|Repeated measures ANOVA||||0.084|0.035|<.0001
71805252|NCT00144339|143110465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|||<|0.0001||95.0|0.157|0.213|||ANOVA|Repeated measures ANOVA||||0.213|0.157|<.0001
71805253|NCT00144339|143110466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047||||0.0005||95.0|0.021|0.074|||ANOVA|Repeated measures ANOVA||||0.074|0.021|0.0005
71842067|NCT03583333|143195027|NON_INFERIORITY|Non-inferiority margin for the difference in mortality (IMI/REL minus PIP/TAZ) was 12.5%.|Adjusted difference in percentage|5.2||||0.024|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen method||Adjusted differences and the 95% confidence intervals (CIs) are based on Miettinen \& Nurminen method stratified by randomization stratum.|||12.4|-1.5|0.024
71894383|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-4.86|||||TWO_SIDED|95.0|-14.4|4.39||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.39|-14.40|
71675523|NCT02837731|142868421|OTHER||Mean Difference (Final Values)|-0.124||||0.042|TWO_SIDED|95.0|-0.27|-0.01|||Fisher Exact||Converted Estimated Value of -12.4% to decimal value of -0.124.|||-0.01|-0.27|0.042
71805254|NCT00144339|143110467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.0001||95.0|0.17|0.229|||ANOVA|Repeated measures ANOVA||||0.229|0.170|<.0001
71805255|NCT00144339|143110468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.038|0.093|||ANOVA|Repeated measures ANOVA||||0.093|0.038|<.0001
71805256|NCT00144339|143110469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|||<|0.0001||95.0|0.154|0.215|||ANOVA|Repeated measures ANOVA||||0.215|0.154|<.0001
71805257|NCT00144339|143110470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046||||0.002||95.0|0.017|0.076|||ANOVA|Repeated measures ANOVA||||0.076|0.017|0.0020
71842068|NCT03583333|143195027|SUPERIORITY||Adjusted difference in percentage|5.2||||0.938|TWO_SIDED|95.0|-1.5|12.4|||Miettinen & Nurminen|Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.||||12.4|-1.5|0.938
71842069|NCT03583333|143195028|OTHER||Adjusted difference in percentage|3.1|||||TWO_SIDED|95.0|-8.7|14.9|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.9|-8.7|
71805258|NCT00144339|143110471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.139|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.139|<.0001
71805259|NCT00144339|143110472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0365||95.0|0.002|0.061|||ANOVA|Repeated measures ANOVA||||0.061|0.002|0.0365
71805260|NCT00144339|143110473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.147|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.147|<.0001
71805261|NCT00144339|143110474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.0002||95.0|0.018|0.058|||ANOVA|Repeated measures ANOVA||||0.058|0.018|0.0002
71805262|NCT00144339|143110475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.0001||95.0|0.161|0.21|||ANOVA|Repeated measures ANOVA||||0.210|0.161|<.0001
71805263|NCT00144339|143110476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037||||0.0018||95.0|0.014|0.06|||ANOVA|Repeated measures ANOVA||||0.060|0.014|0.0018
71805264|NCT00144339|143110477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|||<|0.0001||95.0|0.151|0.201|||ANOVA|Repeated measures ANOVA||||0.201|0.151|<.0001
71805265|NCT00144339|143110478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0069||95.0|0.009|0.055|||ANOVA|Repeated measures ANOVA||||0.055|0.009|0.0069
71805266|NCT00144339|143110479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.127|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.127|<.0001
71805267|NCT00144339|143110480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.002||95.0|0.015|0.065|||ANOVA|Repeated measures ANOVA||||0.065|0.015|0.0020
71805268|NCT00144339|143110481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||<|0.0001||95.0|0.139|0.194|||ANOVA|Repeated measures ANOVA||||0.194|0.139|<.0001
71805269|NCT00144339|143110482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032||||0.0165||95.0|0.006|0.057|||ANOVA|Repeated measures ANOVA||||0.057|0.006|0.0165
71805270|NCT00144339|143110483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.141|0.199|||ANOVA|Repeated measures ANOVA||||0.199|0.141|<.0001
71805271|NCT00144339|143110484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.0248||95.0|0.004|0.059|||ANOVA|Repeated measures ANOVA||||0.059|0.004|0.0248
71805272|NCT00144339|143110485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|||<|0.0001||95.0|0.136|0.196|||ANOVA|Repeated measures ANOVA||||0.196|0.136|<.0001
71805273|NCT00144339|143110486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.0004||95.0|0.022|0.078|||ANOVA|Repeated measures ANOVA||||0.078|0.022|0.0004
71805274|NCT00144339|143110487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||<|0.0001||95.0|0.13|0.192|||ANOVA|Repeated measures ANOVA||||0.192|0.130|<.0001
71805275|NCT00144339|143110488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027||||0.0809||95.0|-0.003|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.003|0.0809
71805276|NCT00144339|143110489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.0001||95.0|0.119|0.182|||ANOVA|Repeated measures ANOVA||||0.182|0.119|<.0001
71805277|NCT00144339|143110490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026||||0.0915||95.0|-0.004|0.057|||ANOVA|Repeated measures ANOVA||||0.057|-0.004|0.0915
71805278|NCT00144339|143110491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88|||<|0.0001||95.0|-3.535|-2.226|||ANOVA|Repeated measures ANOVA||||-2.226|-3.535|<.0001
71805279|NCT00144339|143110492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.771|||<|0.0001||95.0|-3.461|-2.081|||ANOVA|Repeated measures ANOVA||||-2.081|-3.461|<.0001
71805280|NCT00144339|143110493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.593|||<|0.0001||95.0|-3.352|-1.834|||ANOVA|Repeated measures ANOVA||||-1.834|-3.352|<.0001
71805281|NCT00144339|143110494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.384|||<|0.0001||95.0|-3.191|-1.576|||ANOVA|Repeated measures ANOVA||||-1.576|-3.191|<.0001
71805282|NCT00144339|143110495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.423|||<|0.0001||95.0|-3.277|-1.569|||ANOVA|Repeated measures ANOVA||||-1.569|-3.277|<.0001
71805283|NCT00144339|143110496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.345|||<|0.0001||95.0|-4.229|-2.462|||ANOVA|Repeated measures ANOVA||||-2.462|-4.229|<.0001
71805284|NCT00144339|143110497|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.818|||<|0.0001||95.0|-3.742|-1.894|||ANOVA|Repeated measures ANOVA||||-1.894|-3.742|<.0001
71805285|NCT00144339|143110498|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.303|||<|0.0001||95.0|-3.266|-1.34|||ANOVA|Repeated measures ANOVA||||-1.340|-3.266|<.0001
71805286|NCT00144339|143110499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|STANDARD_ERROR_OF_MEAN|0.06||0.0242||95.0|0.74|0.98|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||0.98|0.74|0.0242
71805287|NCT00144339|143110500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|STANDARD_ERROR_OF_MEAN|0.06||0.0339||95.0|0.76|0.99|||Log Rank||Cox regression; cut-off at 4 years ; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|Hazard ratio of all cause mortality vital status was information followed-up after discontinuation; vital status information up to 1440 days after the start of treatment was used||0.99|0.76|0.0339
71805288|NCT00144339|143110501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|STANDARD_ERROR_OF_MEAN|0.06||0.0859||95.0|0.79|1.02|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|||1.02|0.79|0.0859
71805289|NCT00144339|143110502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1936||95.0|0.67|1.08|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo|||1.08|0.67|0.1936
71805290|NCT00144339|143110503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.2377||95.0|0.71|1.09|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo|||1.09|0.71|0.2377
71805291|NCT00144339|143110504|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.029||95.0|0.73|0.98|||Z-test|incidence rate = number of patients with event/ time at risk|Rate ratio of incidence rates (tiotropium/placebo)|||0.98|0.73|0.0290
71805292|NCT00144339|143110505|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.44||||0.1158||95.0|0.91|2.26|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||2.26|0.91|0.1158
71805293|NCT00144339|143110506|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.7725||95.0|0.68|1.33|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.33|0.68|0.7725
71805294|NCT00144339|143110507|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.25||||0.2666||95.0|0.84|1.87|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.87|0.84|0.2666
71805295|NCT00144339|143110508|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.59||||0.0337||95.0|0.37|0.96|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.96|0.37|0.0337
71805296|NCT00144339|143110509|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.58||||0.0537||95.0|0.33|1.01|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.01|0.33|0.0537
71805297|NCT00144339|143110510|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.71||||0.0403||95.0|0.52|0.99|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.99|0.52|0.0403
71805298|NCT00144339|143110511|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0001||95.0|0.77|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.77|0.0001
71805299|NCT00144339|143110512|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|1.2||||0.4789||95.0|0.73|1.98|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.98|0.73|0.4789
71805300|NCT00144339|143110513|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.84||||0.0014||95.0|0.76|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.76|0.0014
71805301|NCT00144339|143110514|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.61||||0.0236||95.0|0.4|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.94|0.40|0.0236
71805302|NCT00144339|143110515|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.95||||0.5064||95.0|0.81|1.11|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||1.11|0.81|0.5064
71805303|NCT00144339|143110516|SUPERIORITY_OR_OTHER||Rate ratio of incidence rates|0.69||||0.0104||95.0|0.52|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)|||0.92|0.52|0.0104
71805304|NCT00690755|143110532|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||.001
71842070|NCT03583333|143195029|OTHER||Adjusted difference in percentage|2.2|||||TWO_SIDED|95.0|-12.4|16.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||16.8|-12.4|
71842071|NCT03583333|143195030|OTHER||Adjusted difference in percentage|3.4|||||TWO_SIDED|95.0|-7.6|14.3|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.3|-7.6|
71805305|NCT02830594|143110534|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.6|||||||Paired t Test|||||||0.60
71805306|NCT02830594|143110535|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.87|||||||Paired t Test|||||||0.87
71805307|NCT02830594|143110536|EQUIVALENCE|Specifically, a sample-size of 14 patients will have 80% power to detect an effect size of 0.71 using a paired t-test with a 0.05 one-sided significance level. The effect size is the mean difference divided by the standard deviation of the difference.||||||0.64|||||||Paired t Test|||||||0.64
71805308|NCT01764945|143110541|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.58|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|73.69|92.54|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||92.54|73.69|
71805309|NCT01764945|143110541|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.34|STANDARD_DEVIATION|22.2|||TWO_SIDED|90.0|73.65|94.3|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||94.30|73.65|
71805310|NCT01764945|143110541|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.92|STANDARD_DEVIATION|19.6|||TWO_SIDED|90.0|74.69|94.28|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||94.28|74.69|
71805311|NCT01764945|143110541|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.9|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|88.94|97.04|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||97.04|88.94|
71805312|NCT01764945|143110541|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|96.37|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|91.55|101.43|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||101.43|91.55|
71805313|NCT01764945|143110541|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.44|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|89.88|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||99.24|89.88|
71805314|NCT01764945|143110542|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|74.07|STANDARD_DEVIATION|21.5|||TWO_SIDED|90.0|65.44|83.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||83.83|65.44|
71805315|NCT01764945|143110542|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|73.23|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|63.33|84.68|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||84.68|63.33|
71805316|NCT01764945|143110542|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.76|STANDARD_DEVIATION|22.7|||TWO_SIDED|90.0|68.94|89.99|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||89.99|68.94|
71805317|NCT01764945|143110542|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.3|STANDARD_DEVIATION|22.5|||TWO_SIDED|90.0|71.42|85.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||85.84|71.42|
71805318|NCT01764945|143110542|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.43|STANDARD_DEVIATION|30.4|||TWO_SIDED|90.0|69.54|88.46|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||88.46|69.54|
71805319|NCT01764945|143110542|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.09|STANDARD_DEVIATION|29.4|||TWO_SIDED|90.0|69.35|87.94|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||87.94|69.35|
71813570|NCT04858802|143129482|SUPERIORITY||Mean Difference (Final Values)|-2.46|STANDARD_DEVIATION|35.55||0.634|TWO_SIDED|95.0|-12.8|7.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 21||7.9|-12.8|0.634
71813571|NCT04858802|143129482|SUPERIORITY||Mean Difference (Final Values)|-7.63|STANDARD_DEVIATION|29.04||0.048|TWO_SIDED|95.0|-15.2|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 45||-0.1|-15.2|0.048
71675524|NCT02837731|142868422|OTHER||Mean Difference (Final Values)|-0.1642||||0.044|TWO_SIDED|95.0|-0.33|0.0|||Chi-squared||Converted Estimated Value of -16.42% to decimal value of -0.1642.|||0|-0.33|0.044
71805320|NCT01764945|143110543|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.02|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|75.98|88.55|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."||88.55|75.98|
71805321|NCT01764945|143110543|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|80.93|STANDARD_DEVIATION|14.5|||TWO_SIDED|90.0|74.58|87.83|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."||87.83|74.58|
71805322|NCT01764945|143110543|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|79.6|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|74.84|84.67|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."||84.67|74.84|
71805323|NCT01764945|143110543|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|91.59|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|87.53|95.84|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."||95.84|87.53|
71805324|NCT01764945|143110543|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.38|STANDARD_DEVIATION|12.4|||TWO_SIDED|90.0|89.76|99.24|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."||99.24|89.76|
71805325|NCT01764945|143110543|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.91|STANDARD_DEVIATION|12.0|||TWO_SIDED|90.0|88.42|97.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."||97.63|88.42|
71805326|NCT02911948|143110547|SUPERIORITY|Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.0% for null hypothesis (H0): D=0.0% against the alternative (HA): D≠0.0%, where D is the mean difference (IDegLira - IDeg).|Treatment contrast|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.06|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment and pre-trial anti-diabetic treatment as fixed factors and corresponding baseline HbA1c value as covariate.||-1.06|-1.50|<0.0001
71842072|NCT03583333|143195031|OTHER||Adjusted difference in percentage|-4.7|||||TWO_SIDED|95.0|-15.8|6.6|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||6.6|-15.8|
71805327|NCT04773015|143110585|OTHER|||||||0.6371|||||||Fisher Exact|||||||0.6371
71805328|NCT04773015|143110586|OTHER|||||||0.1448|||||||Fisher Exact|||||||0.1448
71842073|NCT03583333|143195032|OTHER||Adjusted difference in percentage|-2.4|||||TWO_SIDED|95.0|-17.8|13.1|||||Adjusted differences and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||13.1|-17.8|
71842074|NCT03583333|143195033|OTHER||Adjusted difference in percentage|1.4|||||TWO_SIDED|95.0|-16.5|19.8|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||19.8|-16.5|
71842075|NCT03583333|143195034|OTHER||Adjusted difference in percentage|-3.1|||||TWO_SIDED|95.0|-19.8|14.4|||||Adjusted difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||14.4|-19.8|
71675525|NCT02837731|142868423|OTHER||Mean Difference (Final Values)|-2.91||||0.113|TWO_SIDED|95.0|-6.67|0.85|||Fisher Exact|||||0.85|-6.67|0.113
71805329|NCT04773015|143110587|OTHER|||||||0.1507|||||||Fisher Exact|||||||0.1507
71805330|NCT04773015|143110588|OTHER|||||||0.1189|||||||Fisher Exact|||||||0.1189
71805331|NCT02276482|143110610|OTHER||Difference in percentages|3.6|||||TWO_SIDED|95.0|-6.3|13.5|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||13.5|-6.3|
71805332|NCT02276482|143110611|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-3.4|10.8|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||10.8|-3.4|
71805333|NCT02276482|143110612|OTHER||Difference in percentages|-4.2|||||TWO_SIDED|95.0|-12.9|4.4|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||4.4|-12.9|
71805334|NCT02276482|143110613|OTHER||Difference in percentages|0.2|||||TWO_SIDED|95.0|-7.4|7.7|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||7.7|-7.4|
71805335|NCT02276482|143110614|OTHER||Difference in percentages|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.|||0.0|0.0|
71813572|NCT04858802|143129482|SUPERIORITY||Mean Difference (Final Values)|-7.78|STANDARD_DEVIATION|28.79||0.028|TWO_SIDED|95.0|-14.7|-0.9||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 90||-0.9|-14.7|0.028
71813573|NCT04858802|143129482|SUPERIORITY||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|27.99||0.041|TWO_SIDED|95.0|-13.2|-0.3||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean inflammation score in the frontal recess/FSO minus balloon sinus dilation alone mean inflammation score in the frontal recess/FSO|Day 180||-0.3|-13.2|0.041
71805336|NCT01165281|143110623|NON_INFERIORITY_OR_EQUIVALENCE|In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.226||0.786|TWO_SIDED|95.0|-0.506|0.383|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and country as factors and baseline pain intensity score as a covariate.||The primary hypothesis to be tested for the study was that the JNS024 ER group was not inferior to oxycodone CR as defined by the upper limit of the 95% confidence interval of the difference between JNS024 ER and oxycodone CR on the mean change from baseline of the NRS pain intensity score during the last 3 days of study drug administration. It was to be concluded that JNS024 ER is not inferior to oxycodone CR if the upper 95% confidence limit is less than 1 point.||0.383|-0.506|0.786
71805337|NCT00364858|143110638|SUPERIORITY_OR_OTHER||Agresti and Min|-0.176||||||95.0|-0.357|0.058||||||Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).||0.058|-0.357|
71805338|NCT00627705|143110651|SUPERIORITY_OR_OTHER|||||||0.449|||||||mixed effects regression models|F= 0.81||Cohen's d = 0.30||||0.449
71805339|NCT00627705|143110653|SUPERIORITY_OR_OTHER||||||<|0.001||||||Aberrant Behavior Checklist irritability subscale (F = 6.80; p = \<.001; d = .96).|Mixed effects regression models|||F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen's d was computed based on the standardized mean difference in the change from baseline to week 12.||||<.001
71805340|NCT00627705|143110655|SUPERIORITY_OR_OTHER|||||||0.141|||||||mixed effects regression models|degrees of freedom were 1, 22||F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.||||.141
71805341|NCT02099006|143110673|SUPERIORITY_OR_OTHER|||||||0.3|||||||t-test, 2 sided|Paired T test||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.||||0.30
71805342|NCT02099006|143110673|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.||||0.33
71805343|NCT02099006|143110673|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.||||0.65
71842076|NCT03583333|143195035|OTHER||Adjusted difference in percentage|2.0|||||TWO_SIDED|95.0|-6.5|10.6|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||10.6|-6.5|
71894384|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-19.0|||||TWO_SIDED|95.0|-30.1|-7.16||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-7.16|-30.10|
71805344|NCT02099006|143110673|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.||||0.25
71805345|NCT02099006|143110673|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.||||1.0
71805346|NCT02099006|143110674|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.||||0.31
71805347|NCT02099006|143110674|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.||||1
71805348|NCT02099006|143110674|SUPERIORITY_OR_OTHER|||||||0.66|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.||||0.66
71805349|NCT02099006|143110674|SUPERIORITY_OR_OTHER|||||||0.42|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.||||0.42
71805350|NCT02099006|143110674|SUPERIORITY_OR_OTHER|||||||0.79|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.||||0.79
71805351|NCT00809757|143110685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-1.412|0.342|||||Difference is Placebo MDI minus Levalbuterol UDV|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.342|-1.412|
71805352|NCT00809757|143110685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-1.714|0.335|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations||0.335|-1.714|
71842077|NCT03583333|143195036|OTHER||Adjusted difference in percentage|-4.4|||||TWO_SIDED|95.0|-10.7|1.4|||||Difference and the 95% CIs are based on Miettinen \& Nurminen method stratified by randomization stratum.|||1.4|-10.7|
71842078|NCT03926130|143195037|SUPERIORITY||Risk Difference (RD)|28.7|||<|1e-06|TWO_SIDED|95.0|23.0|34.4|||Cochran-Mantel-Haenszel|||||34.4|23.0|<0.000001
71842079|NCT03926130|143195038|SUPERIORITY||Risk Difference (RD)|25.8|||<|1e-06|TWO_SIDED|95.0|18.8|32.7|||Cochran-Mantel-Haenszel|||||32.7|18.8|<0.000001
71842080|NCT03926130|143195039|SUPERIORITY||Risk Difference (RD)|19.7|||<|1e-06|TWO_SIDED|95.0|13.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|13.7|<0.000001
71842081|NCT03926130|143195040|SUPERIORITY||Risk Difference (RD)|39.1|||<|1e-06|TWO_SIDED|95.0|33.4|44.8|||Cochran-Mantel-Haenszel|||||44.8|33.4|<0.000001
71842082|NCT03926130|143195040|SUPERIORITY||Risk Difference (RD)|2.3||||0.513623|TWO_SIDED|95.0|-4.7|9.3|||Cochran-Mantel-Haenszel|||||9.3|-4.7|0.513623
71675526|NCT02837731|142868424|OTHER||Mean Difference (Final Values)|-72.43|||||TWO_SIDED|95.0|-154.08|9.22|||Wilcoxon (Mann-Whitney)|||||9.22|-154.08|
71675527|NCT02837731|142868425|OTHER||Mean Difference (Final Values)|-14.91||||0.426|TWO_SIDED|95.0|-52.5|22.68|||Wilcoxon (Mann-Whitney)|||||22.68|-52.50|0.426
71675528|NCT02837731|142868426|OTHER||Mean Difference (Final Values)|0.09||||0.453|TWO_SIDED|95.0|-0.34|0.52|||ANCOVA|||||0.52|-0.34|0.453
71675529|NCT02644668|142868444|SUPERIORITY||Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.9086|TWO_SIDED|95.0|-0.13|0.11|||Mixed Models Analysis|||||0.11|-0.13|0.9086
71675530|NCT02644668|142868444|SUPERIORITY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.065||0.4361|TWO_SIDED|95.0|-0.18|0.08|||Mixed Models Analysis|||||0.08|-0.18|0.4361
71675531|NCT02644668|142868445|SUPERIORITY||Least squares mean difference|-2.94|STANDARD_ERROR_OF_MEAN|4.749||0.5382|TWO_SIDED|95.0|-12.43|6.55|||Mixed Models Analysis|||||6.55|-12.43|0.5382
71675532|NCT02644668|142868445|SUPERIORITY||Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|5.099||0.8464|TWO_SIDED|95.0|-9.19|11.18|||Mixed Models Analysis|||||11.18|-9.19|0.8464
71842083|NCT03926130|143195041|SUPERIORITY||Risk Difference (RD)|12.4||||0.001431|TWO_SIDED|95.0|5.3|19.6|||Cochran-Mantel-Haenszel|||||19.6|5.3|0.001431
71842084|NCT03926130|143195042|SUPERIORITY||Risk Difference (RD)|34.6|||<|1e-06|TWO_SIDED|95.0|27.7|41.4|||Cochran-Mantel-Haenszel|||||41.4|27.7|<0.000001
71675533|NCT02644668|142868446|SUPERIORITY||Least squares mean difference|11.69|STANDARD_ERROR_OF_MEAN|5.506||0.0378|TWO_SIDED|95.0|0.68|22.7|||Mixed Models Analysis|||||22.70|0.68|0.0378
71842085|NCT03926130|143195042|NON_INFERIORITY|The non-inferiority margin is 10%. We do not have power calculation in the SAP for this endpoint.|Risk Difference (RD)|5.7|||<|0.0001|TWO_SIDED|95.0|-1.4|12.8|||Z test|||||12.8|-1.4|<0.0001
71842086|NCT03926130|143195043|SUPERIORITY||Risk Difference (RD)|6.8||||0.003414|TWO_SIDED|95.0|3.2|10.5|||Cochran-Mantel-Haenszel|||||10.5|3.2|0.003414
71842087|NCT03926130|143195044|SUPERIORITY||LSMean Difference (Net)|-0.86||||1.1e-05|TWO_SIDED|95.0|-1.24|-0.48|||ANCOVA|||||-0.48|-1.24|0.000011
71842088|NCT03926130|143195045|SUPERIORITY||LSMean Difference (Net)|-2.01|||<|1e-06|TWO_SIDED|95.0|-2.42|-1.6|||ANCOVA|||||-1.60|-2.42|<0.000001
71842089|NCT03926130|143195046|SUPERIORITY||Risk Difference (RD)|25.7|||<|1e-06|TWO_SIDED|95.0|18.9|32.6|||Cochran-Mantel-Haenszel|||||32.6|18.9|<0.000001
71842090|NCT03926130|143195047|SUPERIORITY||Risk Difference (RD)|13.8|||<|1e-06|TWO_SIDED|95.0|10.2|17.4|||Cochran-Mantel-Haenszel|||||17.4|10.2|<0.000001
71842091|NCT03926130|143195048|SUPERIORITY||Risk Difference (RD)|25.0|||<|1e-06|TWO_SIDED|95.0|18.2|31.8|||Cochran-Mantel-Haenszel|||||31.8|18.2|<0.000001
71842092|NCT03926130|143195049|SUPERIORITY||LSMean Difference (Net)|-0.85|||<|1e-06|TWO_SIDED|95.0|-1.05|-0.65|||ANCOVA|||||-0.65|-1.05|<0.000001
71675534|NCT02644668|142868446|SUPERIORITY||Least squares mean difference|13.15|STANDARD_ERROR_OF_MEAN|5.913||0.0298|TWO_SIDED|95.0|1.33|24.97|||Mixed Models Analysis|||||24.97|1.33|0.0298
71675535|NCT02644668|142868447|SUPERIORITY||Least squares mean difference|-4.59|STANDARD_ERROR_OF_MEAN|7.56||0.5461|TWO_SIDED|95.0|-19.69|10.52|||Mixed Models Analysis|||||10.52|-19.69|0.5461
71675536|NCT02644668|142868447|SUPERIORITY||Least squares mean difference|-15.23|STANDARD_ERROR_OF_MEAN|8.175||0.0672|TWO_SIDED|95.0|-31.56|1.11|||Mixed Models Analysis|||||1.11|-31.56|0.0672
71675537|NCT02644668|142868448|SUPERIORITY||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.928||0.6849|TWO_SIDED|95.0|-2.23|1.48|||Mixed Models Analysis|||||1.48|-2.23|0.6849
71675538|NCT02644668|142868448|SUPERIORITY||Least squares mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.98||0.3091|TWO_SIDED|95.0|-2.96|0.95|||Mixed Models Analysis|||||0.95|-2.96|0.3091
71675539|NCT02644668|142868449|SUPERIORITY||Least squares mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.571||0.2878|TWO_SIDED|95.0|-0.53|1.75|||Mixed Models Analysis|||||1.75|-0.53|0.2878
71675540|NCT02644668|142868449|SUPERIORITY||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.616||0.8512|TWO_SIDED|95.0|-1.34|1.11|||Mixed Models Analysis|||||1.11|-1.34|0.8512
71675541|NCT02644668|142868450|SUPERIORITY||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|2.528||0.7612|TWO_SIDED|95.0|-6.08|4.52|||Mixed Models Analysis|||||4.52|-6.08|0.7612
71675542|NCT02644668|142868450|SUPERIORITY||Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|3.231||0.3502|TWO_SIDED|95.0|-9.91|3.7|||Mixed Models Analysis|||||3.70|-9.91|0.3502
71675543|NCT02644668|142868451|SUPERIORITY||Least squares mean difference|7.72|STANDARD_ERROR_OF_MEAN|10.484||0.4684|TWO_SIDED|95.0|-13.86|29.3|||Mixed Models Analysis|||||29.30|-13.86|0.4684
71675544|NCT02644668|142868451|SUPERIORITY||Least squares mean difference|24.89|STANDARD_ERROR_OF_MEAN|12.55||0.0584|TWO_SIDED|95.0|-0.95|50.74|||Mixed Models Analysis|||||50.74|-0.95|0.0584
71675545|NCT02644668|142868452|SUPERIORITY||Odds Ratio (OR)|0.43||||0.1686|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||1.43|0.13|0.1686
71675546|NCT02644668|142868452|SUPERIORITY||Odds Ratio (OR)|0.67||||0.5259|TWO_SIDED|95.0|0.2|2.3|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||2.30|0.20|0.5259
71675547|NCT02644668|142868453|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7655|TWO_SIDED|95.0|0.34|4.4|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||4.40|0.34|0.7655
71675548|NCT02644668|142868453|SUPERIORITY||Odds Ratio (OR)|1.61||||0.492|TWO_SIDED|95.0|0.41|6.25|||Regression, Logistic|||Odds ratio of active vs placebo comparison of the patients' global assessment of better than pre-dose vs same or worse than pre-dose||6.25|0.41|0.4920
71675549|NCT02547220|142868503|SUPERIORITY||Difference in percentage|2.6||||0.6857|TWO_SIDED|95.0|-29.4|34.5|||Fisher Exact||Difference in percentage was calculated by the difference in percentage of new or worsening TG at 6 months between CINRYZE and placebo|||34.5|-29.4|0.6857
71675550|NCT03771560|142868527|OTHER||Mean Difference (Final Values)|-2.4||||0.56|TWO_SIDED|95.0|-11.3|6.4|||Paired Sample t-test|||The parent-reported change in mean ABC total score from baseline to week 12.||6.4|-11.3|0.56
71842093|NCT03926130|143195050|SUPERIORITY||LSMean Difference (Net)|-1.22|||<|1e-06|TWO_SIDED|95.0|-1.48|-0.95|||ANCOVA|||||-0.95|-1.48|<0.000001
71842094|NCT03926130|143195051|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71842095|NCT03926130|143195052|SUPERIORITY||Risk Difference (RD)|4.1||||0.732715|TWO_SIDED|95.0|-18.0|26.1|||Cochran-Mantel-Haenszel|||||26.1|-18.0|0.732715
71805353|NCT00809757|143110685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-1.08|0.771|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.||0.771|-1.080|
71805354|NCT01410448|143110721|SUPERIORITY_OR_OTHER|||||||0.0921|||||||Regression, Logistic|||||||0.0921
71805355|NCT01308580|143110738|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.214|Hazard Ratio (HR)|1.024|||||ONE_SIDED|98.89||1.184|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m\^2 relative to 25 mg/m\^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m\^2 versus 25 mg/m\^2) was less than the non-inferiority margin of 1.214.||1.184||
71805356|NCT01308580|143110738|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024|||||ONE_SIDED|95.0|0.922||||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m\^2 was considered to be superior to 20 mg/m\^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.|||0.922|
71805357|NCT01308580|143110739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.099|||||TWO_SIDED|95.0|0.974|1.24|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.24|0.974|
71805358|NCT01308580|143110740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.096|||||TWO_SIDED|95.0|0.902|1.331|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.331|0.902|
71805359|NCT01308580|143110742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||||TWO_SIDED|95.0|1.025|1.393|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.393|1.025|
71805360|NCT01308580|143110744|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046|||||TWO_SIDED|95.0|0.874|1.251|||||Cabazitaxel 20 mg/m\^2 vs Cabazitaxel 25 mg/m\^2|Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.||1.251|0.874|
71805361|NCT01218438|143110756|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.012|||<|0.0001|ONE_SIDED|99.0||0.024|||Poisson|||||0.024||<0.0001
71805362|NCT04295564|143110856|SUPERIORITY||Mean Difference (Final Values)|82.1|||<|0.05|TWO_SIDED|95.0|8.3|155.9||This is a calculate p value|Mixed Models Analysis|adjusted for the correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing||||155.9|8.3|<0.05
71805363|NCT04295564|143110857|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.02|TWO_SIDED|95.0|0.1|1.1||This is a calculated p value|Mixed Models Analysis|Adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient test.||||1.1|0.1|<0.02
71805364|NCT04295564|143110858|SUPERIORITY||Mean Difference (Final Values)|62.7|||<|0.05|TWO_SIDED|95.0|4.5|121.0||This is a calculated p value|Mixed Models Analysis|P-value adjusted for correlation between twin pairs and gestational age at birth (stratification variable), sex, and length at outpatient testing.||||121|4.5|<0.05
71805365|NCT04295564|143110859|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31||This is a calculated p value|Regression, Logistic|||||1.31|0.27|>0.05
71805366|NCT04295564|143110859|SUPERIORITY||Odds Ratio (OR)|0.59|||>|0.05|TWO_SIDED|95.0|0.27|1.31|||Regression, Logistic|Adjusted for gestational age at birth (stratification variable)||||1.31|0.27|>0.05
71805367|NCT01928719|143110892|OTHER||Hazard Ratio (HR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.95|5.58|||Regression, Cox||The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||5.58|1.95|<0.0001
71805368|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|3.4|||<|0.0001|TWO_SIDED|95.0|1.99|5.81||Testing the effect of treatment group in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Age Group, Working Status, and BMI.|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|The reference group is Same Nicotine Content Group.||5.81|1.99|<0.0001
71805369|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.51||||0.06|TWO_SIDED|95.0|0.26|1.03||Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 30-39 to the Age group 18-29.|The reference group is Age equals 18-29.||1.03|0.26|0.06
71805370|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.17|0.66||Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 40-49 to the Age group 18-29.|The reference group is Age equals 18-29.||0.66|0.17|<0.002
71805371|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.33|||<|0.002|TWO_SIDED|95.0|0.16|0.65||Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 50-59 to Age group 18-29.|The reference group is Age equals 18-29.||0.65|0.16|<0.002
71805372|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.39||||0.1|TWO_SIDED|95.0|0.13|1.18||Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 60-65 to the Age group 18-29.|The reference group is Age equals 18-29.||1.18|0.13|0.1
71842096|NCT03926130|143195053|SUPERIORITY||LSMean Difference (Net)|27.92|||<|1e-06|TWO_SIDED|95.0|22.67|33.18|||ANCOVA|||||33.18|22.67|<0.000001
71842097|NCT03926130|143195055|SUPERIORITY||Risk Difference (RD)|10.6||||0.000213|TWO_SIDED|99.5|4.1|17.2|||Cochran-Mantel-Haenszel|||||17.2|4.1|0.000213
71842098|NCT03926130|143195056|SUPERIORITY||Risk Difference (RD)|19.4|||<|1e-06|TWO_SIDED|99.5|13.1|25.7|||Cochran-Mantel-Haenszel|||||25.7|13.1|<0.000001
71842099|NCT01730937|143195057|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0554|TWO_SIDED|90.0|0.59|1.01|||Log Rank||Reference arm = Sorafenib Alone|Original design: Hypothesized 28% reduction (HR=0.72) with SBRT (corresponds to median OS = 14.5 months). Assuming an exponential distribution and constant hazards, 292 patients were required to reach 238 OS events, with 80% statistical power, a 1-sided α of 0.05. Revised design (see limitations/caveats): For same above hypotheses, at least 155 OS events from 193 randomized patients provided 65% statistical power, with a 1-sided α of 0.05.||1.01|0.59|0.0554
71842100|NCT01730937|143195058|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.034|TWO_SIDED|95.0|0.48|0.99||Two-sided significance level = 0.05|Gray's test||Reference arm = Sorafenib Alone|||0.99|0.48|0.034
71842101|NCT01730937|143195059|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0001|TWO_SIDED|95.0|0.4|0.75||Two-sided significance level=0.05|Log Rank||Reference arm = Sorafenib Alone|||0.75|0.40|0.0001
71842102|NCT06037668|143195209|SUPERIORITY|||||||0.1134||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1134
71842103|NCT06037668|143195210|SUPERIORITY|||||||0.0031||||||p-values are calculated by independent t-test|Independent t-test|||||||0.003100
71842104|NCT06037668|143195211|SUPERIORITY|||||||0.0503||||||p-values are calculated by independent t-test|Independent t-test|||||||0.050300
71842105|NCT06037668|143195212|SUPERIORITY|||||||0.1178||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1178
71805373|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|1.6||||0.1|TWO_SIDED|95.0|0.92|2.66||Testing the effect of working status in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Age, and BMI.||The reference group is not currently working.|The direction of comparison is currently working to not currently working.|2.66|0.92|0.1
71805374|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.25||||0.006|TWO_SIDED|95.0|0.1|0.67||Testing the effect of BMI Normal Weight group (\>=18.5 \& \<25) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Normal Weight (\>=18.5 \& \<25) to Underweight (\<18.5) group.|The reference group is BMI Underweight (\<18.5)||0.67|0.1|0.006
71805375|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.35||||0.034|TWO_SIDED|95.0|0.13|0.92||Testing the effect of BMI Overweight group (\>=25 \& \< 30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Overweight (\>=25 \& \< 30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.92|0.13|0.034
71805376|NCT01928719|143110893|OTHER||Hazard Ratio (HR)|0.31||||0.011|TWO_SIDED|95.0|0.13|0.77||Testing the effect of BMI Obese group (\>=30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Obese (\>=30) to Underweight (\<18.5) group.|The reference group is BMI Underweight group (\<18.5)||0.77|0.13|0.011
71805377|NCT01928719|143110894|OTHER||Least Squares Mean Difference|-4.1||||0.0006|TWO_SIDED|95.0|-6.44|-1.75|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-1.75|-6.44|0.0006
71805378|NCT01928719|143110895|OTHER||Least Squares Mean Difference|-136.7|||<|0.0001|TWO_SIDED|95.0|-171.7|-101.7|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-101.7|-171.7|<.0001
71805379|NCT01928719|143110896|OTHER||Least Squares Mean Difference|-4.03||||0.0305|TWO_SIDED|95.0|-7.68|-0.38|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||-0.38|-7.68|0.0305
71805380|NCT01928719|143110897|OTHER||Least Squares Mean Difference|1.81||||0.0207|TWO_SIDED|95.0|0.28|3.33|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||3.33|0.28|0.0207
71805381|NCT01928719|143110898|OTHER||Least Squares Mean Difference|-0.16||||0.4191|TWO_SIDED|95.0|-0.56|0.23|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|||0.23|-0.56|0.4191
71805382|NCT02250612|143110899|SUPERIORITY|||||||0.93|||||||ANCOVA|||||||0.93
71805383|NCT02250612|143110899|SUPERIORITY|||||||0.92|||||||ANCOVA|||||||0.92
71805384|NCT02250612|143110899|SUPERIORITY|||||||0.23|||||||ANCOVA|||||||0.23
71805385|NCT02250612|143110899|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71805386|NCT02250612|143110899|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
71805387|NCT02250612|143110899|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
71805388|NCT02250612|143110900|SUPERIORITY|||||||0.94|||||||ANCOVA|||||||0.94
71805389|NCT02250612|143110900|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
71805390|NCT02250612|143110900|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71805391|NCT02250612|143110900|SUPERIORITY|||||||0.412|||||||ANCOVA|||||||0.412
71805392|NCT02250612|143110900|SUPERIORITY|||||||0.79|||||||ANCOVA|||||||0.79
71805393|NCT02250612|143110900|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
71805394|NCT05732454|143110932|SUPERIORITY||Difference in percentage|-3.76|||=|0.558|TWO_SIDED|95.0|-16.36|8.83|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||8.83|-16.36|=0.5580
71805395|NCT05732454|143110933|SUPERIORITY||Difference in percentage|9.07|||=|0.3685|TWO_SIDED|95.0|-10.7|28.85|||Cochran-Mantel-Haenszel|||Normal approximation adjusting for the stratification factor (disease severity as measured by baseline IGA score 3 \[moderate\], 4 \[severe\]) derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach was used.||28.85|-10.70|=0.3685
71805396|NCT05732454|143110934|SUPERIORITY||Difference in Mean|-29.22|||=|0.0303|TWO_SIDED|95.0|-55.53|-2.9|||Rubin's rule|||Jump-to-Control (JTC) method was used for evaluation. A complete imputed dataset was analyzed using analysis of covariance model including effects of treatment group, actual stratification factor, and baseline value. Multiple results of the treatment comparison were combined using Rubin's rules, reporting the combined treatment difference, its standard error, 95% CI and 2-sided p-value, across the visits.||-2.90|-55.53|=0.0303
71894385|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|-12.19|||||TWO_SIDED|95.0|-21.66|-3.26||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||-3.26|-21.66|
71894386|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
71894387|NCT01193335|143310959|SUPERIORITY_OR_OTHER||Percent difference|0.02|||||TWO_SIDED|95.0|-4.54|4.68||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.68|-4.54|
71894388|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.8|||||TWO_SIDED|95.0|0.62|1.02||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.62|
71805397|NCT00377819|143110990|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.35%|Mean Difference (Final Values)|0.85|||<|0.0001||95.0|0.44|1.25|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.25|0.44|<0.0001
71805398|NCT00377819|143110991|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.22%|Mean Difference (Final Values)|1.18|||<|0.0001||95.0|0.63|1.73|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction|||1.73|0.63|<0.0001
71805399|NCT00377819|143110992|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Van Elteren Stratified Rank Test|||||||<0.0001
71805400|NCT01914926|143111035|NON_INFERIORITY_OR_EQUIVALENCE|Chi-Square test||||||0.0001||95.0|||||Chi-squared|||We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.||||.0001
71805401|NCT00321919|143111071|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.778976||||0.2036|TWO_SIDED|95.0|0.53|1.14|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.||1.14|0.53|0.2036
71805402|NCT00321919|143111072|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.744575||||0.4833|TWO_SIDED|95.0|0.33|1.7|||Regression, Cox||The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.70|0.33|0.4833
71805403|NCT00321919|143111074|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.658259||||0.1391|TWO_SIDED|95.0|0.38|1.15|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.|||1.15|0.38|0.1391
71805404|NCT00321919|143111077|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.804594||||0.4985|TWO_SIDED|95.0|0.43|1.51|||Regression, Cox||The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group|||1.51|0.43|0.4985
71805405|NCT00321919|143111079|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.82046||||0.3419|TWO_SIDED|95.0|0.55|1.23|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|||1.23|0.55|0.3419
71805406|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.||||0.0029
71805407|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2||||0.0081
71805408|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1||||0.0005
71805409|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0965|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2||||0.0965
71805410|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1||||0.0004
71805411|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.9864|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2||||0.9864
71805412|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1||||0.0097
71805413|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2||||0.1670
71805414|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1||||0.0058
71805415|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.1455|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2||||0.1455
71805416|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1||||0.0009
71805417|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.0123|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2||||0.0123
71805418|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1||||0.3155
71805419|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.7076|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2||||0.7076
71805420|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.1291|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1||||0.1291
71805421|NCT00321919|143111086|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2||||0.5528
71805422|NCT00760929|143111097|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4301||90.0|0.58|1.21|||Wald Test|||||1.21|0.58|0.4301
71805423|NCT00760929|143111097|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0342||90.0|0.42|0.9|||Wald Test|||||0.90|0.42|0.0342
71805424|NCT02099838|143111101|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
71805425|NCT02099838|143111101|SUPERIORITY_OR_OTHER|||||||0.065||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0650
71805426|NCT02099838|143111101|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
71805427|NCT02099838|143111102|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
71805428|NCT02099838|143111102|SUPERIORITY_OR_OTHER|||||||0.0849||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0849
71805429|NCT02099838|143111102|SUPERIORITY_OR_OTHER|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0005
71805430|NCT02099838|143111103|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
71805431|NCT02099838|143111103|SUPERIORITY_OR_OTHER|||||||0.2428||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.2428
71842106|NCT06037668|143195213|SUPERIORITY|||||||0.1003||||||p-values are calculated by independent t-test|Independent t-test|||||||0.1003
71842107|NCT06037668|143195214|SUPERIORITY|||||||0.4832||||||p-values are calculated by independent t-test|Independent t-test|||||||0.4832
71842108|NCT00971087|143195290|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|3D + s2D will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. That is, our null hypothesis is that the AUC for 3D + s2D is 0.05 less than the AUC for 2D FFDM. A difference of 0.05 is considered a clinically significant difference.||||||0.009|||||||MRMC ROC Analysis|||A multi-reader, multi-case ROC analysis will be used to compare 3D + s2D to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance.||||0.009
71842109|NCT00971087|143195291|NON_INFERIORITY|A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit onesided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05.||||||0.045|||||||MRMC ROC Analysis|||||||0.045
71805432|NCT02099838|143111103|SUPERIORITY_OR_OTHER|||||||0.0003||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0003
71842110|NCT04479761|143195293|OTHER|T test derived from a linear mixed effects model|Mean Difference (Final Values)|0.52||||0.005|TWO_SIDED|95.0|||||Mixed Models Analysis||we provided the mean difference between the vestibular group and healthy controls for the reported condition.|||||0.005
71805433|NCT02099838|143111104|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||<0.0001
71805434|NCT02099838|143111104|SUPERIORITY_OR_OTHER|||||||0.7353||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05.||||0.7353
71805435|NCT02099838|143111104|SUPERIORITY_OR_OTHER|||||||0.0013||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0013
71842111|NCT04479761|143195294|OTHER|T tests derived from linear mixed effects model|Mean Difference (Final Values)|0.23||||0.008|TWO_SIDED||||||Mixed Models Analysis||we provided the mean difference between the vestibular group and the controls on the reported condition.|||||0.008
71842112|NCT04011644|143195309|SUPERIORITY|||||||0.688|||||||Mixed Models Analysis|Quanbeck,A.et al. A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder. npj Digit. Med.7,248(2024)||||||0.688
71842113|NCT04011644|143195310|SUPERIORITY|||||||0.261|||||||Mixed Models Analysis|||||||0.261
71842114|NCT04011644|143195311|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
71842115|NCT04011644|143195313|SUPERIORITY|||||||0.908|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.908
71675551|NCT03771560|142868528|OTHER||Mean Difference (Final Values)|1.2||||0.68|TWO_SIDED|95.0|-5.2|7.6|||Paired Sample t-test|||The teacher-reported change in mean ABC total score from baseline to week 12.||7.6|-5.2|0.68
71805436|NCT02099838|143111105|SUPERIORITY_OR_OTHER|||||||0.1147||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.1147
71805437|NCT02099838|143111105|SUPERIORITY_OR_OTHER|||||||0.4006||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4006
71842116|NCT04011644|143195315|SUPERIORITY|||||||0.206|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.206
71842117|NCT04011644|143195316|SUPERIORITY|||||||0.104|||||||ANCOVA|||A univariate analysis (Analysis of Covariance or ANCOVA) was conducted to compare the number of hospital days among the three groups controlling for baseline assessment of the dependent variable and design factors (i.e., Sex and Severity).||||0.104
71842118|NCT04011644|143195317|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71842119|NCT04011644|143195318|SUPERIORITY|||||||0.025|||||||Mixed Models Analysis|||||||0.025
71842120|NCT04011644|143195319|SUPERIORITY|||||||0.555|||||||Mixed Models Analysis|||||||0.555
71842121|NCT04011644|143195320|SUPERIORITY|||||||0.131|||||||Kruskal-Wallis|||||||0.131
71842122|NCT04011644|143195324|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
71842123|NCT05265065|143195342|NON_INFERIORITY|"Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.~The sample size calculation assumed an estimated seroresponse rate of 95% in both half- and full-dose arms, a non- inferiority margin of -10% (absolute difference), a one-sided significance level of5%, and no loss to follow- up. Under this scenario, a sample size of 100 per arm provides 90% power to compare seroresponse rates between arms under the non-inferiority framework."|Risk Difference (RD)|-2.9|||||TWO_SIDED|95.0|-7.7|2.0|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|Non-inferiority margin of -10% (absolute difference) and a one-sided significance level of 5%.||2.0|-7.7|
71842124|NCT05265065|143195344|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-16.1|11.3|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||11.3|-16.1|
71842125|NCT05265065|143195344|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-9.5|3.2|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||3.2|-9.5|
71842126|NCT05265065|143195344|NON_INFERIORITY|Non-inferiority margin of -10% (absolute difference)|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-17.1|16.1|||Regression, Logistic||The difference in seroresponse was adjusted for age group, priming vaccine, duration between first and second dose, duration between second and third (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||16.1|-17.1|
71842127|NCT05265065|143195345|SUPERIORITY||Geometric Mean Ratio|0.94||||0.228|TWO_SIDED|95.0|0.86|1.04|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.04|0.86|0.228
71842128|NCT05265065|143195346|SUPERIORITY||Geometric Mean Ratio|0.94||||0.537|TWO_SIDED|95.0|0.77|1.15|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.15|0.77|0.537
71842129|NCT05265065|143195346|SUPERIORITY||Geometric Mean Ratio|0.99||||0.922|TWO_SIDED|95.0|0.89|1.11|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||1.11|0.89|0.922
71842130|NCT05265065|143195346|SUPERIORITY||Geometric Mean Ratio|0.71||||0.014|TWO_SIDED|95.0|0.54|0.93|||Regression, Linear||Adjusted for age group, priming vaccine, duration between 1st and 2nd dose, duration between 2nd and 3rd (study) dose, study day of blood draw, and baseline anti-spike IgG (IgG).|||0.93|0.54|0.014
71842131|NCT02846545|143195404|SUPERIORITY||Least Square (LS) Mean|-0.178|||=|0.0004|TWO_SIDED|95.0|-0.28|-0.08|||Mixed Models Analysis|||||-0.08|-0.28|= 0.0004
71842132|NCT02846545|143195405|SUPERIORITY||LS Mean|-0.09|||=|0.802|TWO_SIDED|95.0|-0.81|0.63|||Mixed Models Analysis|||||0.63|-0.81|= 0.8020
71675552|NCT03771560|142868529|OTHER||Mean Difference (Final Values)|-7.8||||0.095|TWO_SIDED|95.0|-17.3|1.6|||Paired Sample t-test|||The parent-reported change in mean SRS total score from baseline to week 12.||1.6|-17.3|0.095
71805438|NCT02099838|143111105|SUPERIORITY_OR_OTHER|||||||0.0614||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0614
71842133|NCT02846545|143195406|SUPERIORITY||Ratio of hypoglycemia rates|0.9|||=|0.0036|TWO_SIDED|95.0|0.838|0.966|||Poisson regression model|||Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.||0.966|0.838|= 0.0036
71842134|NCT06468982|143195415|SUPERIORITY|To evaluate whether intra-aortic balloon pump catheter support contributes to a more rapid decrease in troponin levels and faster myocardial recovery, daily troponin levels were analyzed using mixed ANOVA.||||||0.05||||||The p-value was adjusted for multiple comparisons, and the threshold value was set at 0.05.|ANOVA|The hypothesis that IABP causes a rapid increase in troponin levels was analyzed using ANOVA, and the p-value was reported.||After testing for normality, the baseline characteristics of the two groups will be analyzed using the Student's t-test or the Mann-Whitney U-test for continuous variables and the chi-square test or Fisher's exact test for categorical variables. Differences between the intra-aortic balloon pump group and the control group in terms of repeated measurements will be analyzed using mixed ANOVA.||||0.05
71842135|NCT06468982|143195416|OTHER||Hazard Ratio, log|0.55|||<|0.05|TWO_SIDED|95.0|0.38|0.78|||Wilcoxon (Mann-Whitney)|||The prognostic value of risk factors for in-hospital mortality was evaluated by multivariate logistic regression analysis||0.78|0.38|<0.05
71842136|NCT02492711|143195433|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0334|TWO_SIDED|95.0|0.593|0.979|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.979|0.593|0.0334
71842137|NCT02492711|143195434|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.6204|TWO_SIDED|95.0|0.774|1.165|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||1.165|0.774|0.6204
71842138|NCT02492711|143195436|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0014|TWO_SIDED|95.0|0.556|0.87|||Log Rank|Stratified Log-Rank Test|Stratified Cox Proportional Model|||0.870|0.556|0.0014
71805439|NCT02099838|143111106|SUPERIORITY_OR_OTHER|||||||0.3795||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3795
71805440|NCT02099838|143111106|SUPERIORITY_OR_OTHER|||||||0.4236||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.4236
71805441|NCT02099838|143111106|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||1.0000
71842139|NCT03154190|143195456|SUPERIORITY||Hazard Ratio (HR)|0.3|||||TWO_SIDED|95.0|0.2|0.47|||Regression, Cox|||||0.47|0.20|
71842140|NCT03154190|143195457|SUPERIORITY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.3|0.75|||Regression, Cox|||||0.75|0.30|
71842141|NCT03154190|143195460|SUPERIORITY||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.33|0.62||||||||0.62|0.33|
71842142|NCT03154190|143195462|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.36|0.7||||||||0.70|0.36|
71805442|NCT02099838|143111107|SUPERIORITY_OR_OTHER|||||||0.3151||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.3151
71842143|NCT03154190|143195467|SUPERIORITY||Odds Ratio (OR)|4.46|||||TWO_SIDED|95.0|1.88|10.55||||||||10.55|1.88|
71842144|NCT00670241|143195482|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|2.05|5.7|||Cochran-Mantel-Haenszel|||||5.70|2.05|< 0.001
71842145|NCT00670241|143195483|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.51|||<|0.001|TWO_SIDED|98.33|1.46|8.4|||Cochran-Mantel-Haenszel|||||8.40|1.46|<0.001
71842146|NCT00670241|143195484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|98.33|-22.6|-6.9|||ANOVA|||||-6.90|-22.6|<0.001
71842147|NCT05850052|143195519|SUPERIORITY||Odds Ratio (OR)|1.24||||0.26|TWO_SIDED|95.0|0.85|1.79|||proportional-odds cumulative logit model|||||1.79|0.85|0.26
71842148|NCT05850052|143195520|SUPERIORITY||incidence rate ratio|1.02||||0.86|TWO_SIDED|97.5|0.82|1.27|||proportional-odds cumulative logit model|||||1.27|0.82|0.86
71675553|NCT03771560|142868530|OTHER||Median Difference (Final Values)|-0.5||||0.95|TWO_SIDED|95.0|-7.0|13.5|||Wilcoxon (Mann-Whitney)|||The teacher-reported change in mean SRS total score from baseline to week 12.||13.5|-7.0|0.95
71675554|NCT03771560|142868531|OTHER||Mean Difference (Final Values)|-0.8||||0.69|TWO_SIDED|95.0|-5.2|3.5|||Paired Sample t-test|||The parent-reported change in mean PedsQL total score from baseline to week 12.||3.5|-5.2|0.69
71675555|NCT02887183|142868532|OTHER||Least Squared Geometric Mean Ratio|0.632|||<|0.0001|TWO_SIDED|95.0|0.5865|0.681|||ANCOVA|||||0.6810|0.5865|<.0001
71675556|NCT02887183|142868533|OTHER||Least Squared Mean|-7.57|||<|0.0001|TWO_SIDED|95.0|-7.98|-7.15|||ANCOVA|||LAVi||-7.15|-7.98|<.0001
71675557|NCT02887183|142868533|OTHER||Least Squared Mean|-12.25|||<|0.0001|TWO_SIDED|95.0|-12.92|-11.58|||ANCOVA|||LVEDVi||-11.58|-12.92|<.0001
71675558|NCT02887183|142868533|OTHER||Least Squared Mean|-15.29|||<|0.0001|TWO_SIDED|95.0|-16.03|-14.55|||ANCOVA|||LVESVi||-14.55|-16.03|<.0001
71675559|NCT02887183|142868534|OTHER||Least Squared Mean|9.37|||<|0.001|TWO_SIDED|95.0|8.84|9.9|||ANCOVA|||||9.90|8.84|<.001
71675560|NCT02887183|142868535|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
71675561|NCT02887183|142868536|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF||||<.0001
71675562|NCT02887183|142868537|OTHER|Pearson's Correlation|||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||<.0001
71675563|NCT02887183|142868537|OTHER|Pearson's Correlation||||||0.0003|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0003
71675564|NCT02887183|142868537|OTHER|Pearson's Correlation||||||0.0956|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0956
71675565|NCT02887183|142868538|OTHER|Pearson's Correlation||||||0.006|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0060
71675566|NCT02887183|142868538|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0012
71675567|NCT02887183|142868538|OTHER|Pearson's Correlation||||||0.0181|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0181
71675568|NCT02887183|142868539|OTHER|Pearson's Correlation||||||0.2498|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.2498
71675569|NCT02887183|142868539|OTHER|Pearson's Correlation||||||0.0495|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0495
71675570|NCT02887183|142868539|OTHER|Pearson's Correlation||||||0.2685|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.2685
71675571|NCT02887183|142868540|OTHER|Pearson's Correlation||||||0.0029|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve||||0.0029
71675572|NCT02887183|142868540|OTHER|Pearson's Correlation||||||0.0011|TWO_SIDED|95.0|||||t-test, 2 sided|||"Subjects with HFrEF and low NT-proBNP"||||0.0011
71675573|NCT02887183|142868540|OTHER|Pearson's Correlation||||||0.0012|TWO_SIDED|95.0|||||t-test, 2 sided|||Subjects not receiving target dose||||0.0012
71675574|NCT02887183|142868541|OTHER||Least Squared Mean|9.32|||<|0.0001|TWO_SIDED|95.0|7.94|10.69|||ANCOVA|||||10.69|7.94|<.0001
71675575|NCT01031680|142868542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0473|<|0.0001|TWO_SIDED|95.0|-0.56|-0.37||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.37|-0.56|<0.0001
71675576|NCT01031680|142868543|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||<|0.0001|TWO_SIDED|95.0|7.0|12.9||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||12.9|7.0|<0.0001
71675577|NCT01031680|142868544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.7898||0.0126|TWO_SIDED|95.0|-3.52|-0.42||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.42|-3.52|0.0126
71675578|NCT01031680|142868545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001||95.0|-2.64|-1.89||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.89|-2.64|<0.0001
71675579|NCT01031680|142868546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.8203||0.0174|TWO_SIDED|95.0|-3.56|-0.34||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.34|-3.56|0.0174
71675580|NCT01031680|142868547|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.5|STANDARD_ERROR_OF_MEAN|2.126|<|0.0001|TWO_SIDED|95.0|8.3|16.6||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum (gender)||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||16.6|8.3|<0.0001
71675581|NCT01921101|142868556|SUPERIORITY_OR_OTHER|||||||0.29|||||||Chi-squared|||||||0.29
71675582|NCT01483027|142868561|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0013|TWO_SIDED|95.0|0.54|0.88|||Log Rank|||Analysis performed using a log-rank test||0.88|0.54|0.0013
71675583|NCT01483027|142868562|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.77|||Log Rank|||Analysis performed using a log-rank test.||0.77|0.46|<0.0001
71675584|NCT00648115|142868650|SUPERIORITY_OR_OTHER||Pearson chi square|7.3|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71675585|NCT01073605|142868652|SUPERIORITY_OR_OTHER|||||||0.02922|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.02922
71675586|NCT01073605|142868652|SUPERIORITY_OR_OTHER|||||||0.74299|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.74299
71675587|NCT01073605|142868652|SUPERIORITY_OR_OTHER|||||||0.00467|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.00467
71805443|NCT02099838|143111107|SUPERIORITY_OR_OTHER|||||||0.6963||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.6963
71805444|NCT02099838|143111107|SUPERIORITY_OR_OTHER|||||||0.3204||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3204
71805445|NCT02099838|143111108|SUPERIORITY_OR_OTHER|||||||0.0038||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0038
71805446|NCT02099838|143111108|SUPERIORITY_OR_OTHER|||||||0.3812||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3812
71805447|NCT02099838|143111108|SUPERIORITY_OR_OTHER|||||||0.0108||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.0108
71805448|NCT02099838|143111109|SUPERIORITY_OR_OTHER|||||||0.5476||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5476
71805449|NCT02099838|143111109|SUPERIORITY_OR_OTHER|||||||0.1248||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.1248
71842149|NCT05850052|143195521|SUPERIORITY||Risk Ratio (RR)|3.1||||0.36|TWO_SIDED|95.0|0.32|30.0|||Fisher Exact|||||30|0.32|0.36
71842150|NCT05552508|143195610|OTHER|||||||0.0327|||||||t-test, 2 sided|||All participants||||0.0327
71675588|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.00125|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00125
71675589|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.25995|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.25995
71805450|NCT02099838|143111109|SUPERIORITY_OR_OTHER|||||||0.362||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.3620
71842151|NCT05552508|143195610|OTHER|||||||0.0359|||||||t-test, 2 sided|||Participants with \>=4 mucus plugs||||0.0359
71842152|NCT05552508|143195610|OTHER|||||||0.1088|||||||t-test, 2 sided|||Participants with \<4 mucus plugs||||0.1088
71842153|NCT05552508|143195610|OTHER|||||||0.0391|||||||t-test, 2 sided|||Non-OCS-dependent participants||||0.0391
71675590|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||8e-05|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year||||0.00008
71675591|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.03273|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.03273
71675592|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.68581|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.68581
71842154|NCT05552508|143195611|OTHER|||||||0.0423|||||||t-test, 2 sided|||||||0.0423
71842155|NCT05552508|143195612|OTHER|||||||0.9465|||||||t-test, 2 sided|||||||0.9465
71842156|NCT05552508|143195613|OTHER|||||||0.3455|||||||t-test, 2 sided|||||||0.3455
71842157|NCT05552508|143195614|OTHER|||||||0.2484|||||||t-test, 2 sided|||||||0.2484
71842158|NCT05552508|143195615|OTHER|||||||0.9405|||||||t-test, 2 sided|||||||0.9405
71842159|NCT05552508|143195616|OTHER|||||||0.6867|||||||t-test, 2 sided|||||||0.6867
71805451|NCT02099838|143111110|SUPERIORITY_OR_OTHER|||||||0.5636||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.5636
71805452|NCT02099838|143111110|SUPERIORITY_OR_OTHER|||||||0.3681||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.3681
71805453|NCT02099838|143111110|SUPERIORITY_OR_OTHER|||||||0.2589||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.2589
71805454|NCT02099838|143111111|SUPERIORITY_OR_OTHER|||||||0.7972||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.7972
71805455|NCT02099838|143111111|SUPERIORITY_OR_OTHER|||||||0.7801||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7801
71805456|NCT02099838|143111111|SUPERIORITY_OR_OTHER|||||||0.8744||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.8744
71805457|NCT02099838|143111112|SUPERIORITY_OR_OTHER|||||||0.8034||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.8034
71805458|NCT02099838|143111112|SUPERIORITY_OR_OTHER|||||||0.7675||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.7675
71805459|NCT02099838|143111112|SUPERIORITY_OR_OTHER|||||||0.6918||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.6918
71842160|NCT05552508|143195617|OTHER|||||||0.7554|||||||t-test, 2 sided|||||||0.7554
71842161|NCT01199133|143195717|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01|||>|0.05||95.0|-0.41|0.43|||ANCOVA|||||0.43|-0.41|> 0.05
71675593|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.0053|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years||||0.00530
71675594|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.57556|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.57556
71675595|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.63956|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.63956
71805460|NCT02099838|143111113|SUPERIORITY_OR_OTHER|||||||0.0339||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.||||0.0339
71805461|NCT02099838|143111113|SUPERIORITY_OR_OTHER|||||||0.0997||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.||||0.0997
71805462|NCT02099838|143111113|SUPERIORITY_OR_OTHER|||||||0.5015||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.||||0.5015
71805463|NCT03740490|143111126|SUPERIORITY||Mean Difference (Net)|-0.1||||0.284|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis|||Each outcome was modeled using a mixed-effects regression with the change score as the dependent variable and treatment group (Smart-T vs. QuitGuide) as the predictor, restricted to participants who received or would have received that type of message.||0.08|-0.28|0.284
71805464|NCT03740490|143111127|SUPERIORITY||Mean Difference (Net)|0.06||||0.477|TWO_SIDED|95.0|-0.11|0.24|||Mixed Models Analysis|||||0.24|-0.11|0.477
71805465|NCT03740490|143111128|SUPERIORITY||Mean Difference (Net)|0.03||||0.456|TWO_SIDED|95.0|-0.05|0.1|||Mixed Models Analysis|||||0.10|-0.05|0.456
71842162|NCT03988621|143195718|SUPERIORITY||Mean Difference (Net)|-0.65||||0.04|TWO_SIDED|95.0|-1.27|-0.03||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean HSCN scale scores of participants in the intervention group were estimated to decrease by 0.65 (95% CI: -1.27 to -0.03) units more than that of participants in the control group from baseline to 6-months.|||-0.03|-1.27|0.04
71842163|NCT03988621|143195719|SUPERIORITY||Mean Difference (Net)|5.05||||0.01|TWO_SIDED|95.0|1.12|8.98||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Self Care Inventory scale scores of participants in the intervention group were estimated to increase by 5.05 (95% CI: 1.12 to 8.98) units more than that of participants in the control group from baseline to 6-months.|||8.98|1.12|0.01
71842164|NCT03988621|143195720|SUPERIORITY||Mean Difference (Net)|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.48|-2.52||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean PSS scale scores of participants in the intervention group were estimated to decrease by 4.50 (95% CI: -6.48 to -2.52) units more than that of participants in the control group from baseline to 6-months.|||-2.52|-6.48|<0.0001
71805466|NCT03740490|143111129|SUPERIORITY||Mean Difference (Net)|-0.22||||0.215|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.215
71805467|NCT00434057|143111152|SUPERIORITY_OR_OTHER||Sensitivity to melanoma|98.0||||0.05||95.0|95.1|100.0|||exact mid-P||"Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of Melanoma can not be ruled out or Not melanoma, which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas."|MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.||100|95.1|0.05
71805468|NCT00434057|143111152|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.||||0.02
71805469|NCT00823719|143111156|SUPERIORITY_OR_OTHER||percentage of participants|69.0|||||TWO_SIDED|95.0|48.2|85.7|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.|||85.7|48.2|
71805470|NCT00823719|143111156|SUPERIORITY_OR_OTHER||percentage of participants|55.0|||||TWO_SIDED|95.0|36.4|71.9|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.|||71.9|36.4|
71805471|NCT00823719|143111156|SUPERIORITY_OR_OTHER||percentage of participants|61.0|||||TWO_SIDED|95.0|47.4|73.5|||||The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.|||73.5|47.4|
71805472|NCT02896855|143111277|OTHER||Stratified Hazard Ratio|0.69||||0.0418|TWO_SIDED|95.0|0.49|0.99|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||0.99|0.49|0.0418
71805473|NCT02896855|143111277|OTHER||Unstratified Hazard Ratio|0.71||||0.0556|TWO_SIDED|95.0|0.5|1.01|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the primary analysis. Hypothesis testing is considered exploratory in this bridging study.||1.01|0.50|0.0556
71842165|NCT03988621|143195721|SUPERIORITY||Mean Difference (Net)|2.16||||0.099|TWO_SIDED|95.0|-0.41|4.73||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Active Coping Subscale||4.73|-0.41|0.099
71805474|NCT02896855|143111277|OTHER||Stratified Hazard Ratio|0.6||||0.0008|TWO_SIDED|95.0|0.45|0.81|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.81|0.45|0.0008
71805475|NCT02896855|143111277|OTHER||Unstratified Hazard Ratio|0.63||||0.0019|TWO_SIDED|95.0|0.47|0.85|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|This was for the final analysis. Hypothesis testing is considered exploratory in this bridging study.||0.85|0.47|0.0019
71805476|NCT02896855|143111279|OTHER||Stratified Hazard Ratio|0.68||||0.0658|TWO_SIDED|95.0|0.45|1.03|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.03|0.45|0.0658
71805477|NCT02896855|143111279|OTHER||Unstratified Hazard Ratio|0.7||||0.0864|TWO_SIDED|95.0|0.46|1.06|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.06|0.46|0.0864
71805478|NCT02896855|143111281|OTHER||Difference in Objective Response|9.98||||0.1126|TWO_SIDED|95.0|-2.65|22.6|||Cochran-Mantel-Haenszel|Statistical test is stratified by disease type and hormone receptor status.|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1126
71805479|NCT02896855|143111281|OTHER||Difference in Objective Response|9.98||||0.1108|TWO_SIDED|95.0|-2.65|22.6|||Fisher Exact|Unadjusted|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.||22.60|-2.65|0.1108
71805480|NCT02896855|143111282|OTHER||Cox Proportional Hazard|0.78||||0.2867|TWO_SIDED|95.0|0.49|1.24|||Log Rank|Two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.||1.24|0.49|0.2867
71805481|NCT02896855|143111289|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-1.96|0.75|||||The treatment difference for change from baseline to maximum on-treatment decrease in LVEF is defined as Arm B: Pertuzumab minus Arm A: Placebo.|||0.75|-1.96|
71805482|NCT02585895|143111342|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|74.2|||<|0.0001|TWO_SIDED|95.0|44.6|86.8|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by screening LDL-C level|Treatment difference used apheresis as the reference.|||86.8|44.6|< 0.0001
71805483|NCT02585895|143111343|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-52.74|STANDARD_ERROR_OF_MEAN|5.64|<|0.0001|TWO_SIDED|95.0|-64.18|-41.3|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-41.30|-64.18|< 0.0001
71805484|NCT02585895|143111344|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-46.37|STANDARD_ERROR_OF_MEAN|4.67|<|0.0001|TWO_SIDED|95.0|-55.85|-36.9|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.|||-36.90|-55.85|< 0.0001
71805485|NCT02585895|143111345|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-35.8|STANDARD_ERROR_OF_MEAN|3.74|<|0.0001|TWO_SIDED|95.0|-43.39|-28.21|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.||||-28.21|-43.39|< 0.0001
71805486|NCT01380327|143111354|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).|Analysis compared cockroach SLIT -high dose, Placebo - high dose||2.3|1.2|0.001
71805487|NCT01380327|143111354|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.7|3.1|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).|Analysis compared cockroach SLIT - low dose, placebo - low dose||3.1|1.7|<0.0001
71805488|NCT01380327|143111355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3|||<|0.0001|TWO_SIDED|95.0|1.1|1.4|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).|Analysis compared cockroach SLIT - high dose, placebo - high dose||1.4|1.1|<0.0001
71805489|NCT01380327|143111355|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.11|TWO_SIDED|95.0|1.0|1.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).|Analysis compared cockroach SLIT - low dose, placebo - low dose||1.2|1.0|0.11
71842166|NCT03988621|143195721|SUPERIORITY||Mean Difference (Net)|-0.88||||0.25|TWO_SIDED|95.0|-2.38|0.62||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Estimated difference may not be consistent with difference sample means presented in outcome measure data table.|Avoidance Coping Subscale||0.62|-2.38|0.25
71842167|NCT03988621|143195721|SUPERIORITY|The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mean Difference (Net)|-0.31||||0.68|TWO_SIDED|95.0|-1.81|1.18|||Mixed Models Analysis|||Minimization Coping Subscale||1.18|-1.81|0.68
71842168|NCT03988621|143195722|SUPERIORITY||Mean Difference (Net)|-1.32||||0.27|TWO_SIDED|95.0|-3.68|1.04||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis|||Physical Health Score||1.04|-3.68|0.27
71842169|NCT03988621|143195722|SUPERIORITY||Mean Difference (Net)|3.35||||0.04|TWO_SIDED|95.0|0.17|6.53||The p-value for the group-by-time interaction is presented, as well as the estimated mean and confidence interval for difference in 6-month change between intervention and treatment groups.|Mixed Models Analysis||Mean Mental Health scores of participants in the intervention group were estimated to increase by 3.35 (95% CI: 0.17 to 6.53) units more than that of participants in the control group from baseline to 6-months.|Mental Health Score||6.53|0.17|0.04
71805490|NCT01380327|143111356|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.06|TWO_SIDED|95.0|1.0|2.4|||Mixed Models Analysis||Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).|Analysis compared cockroach SLIT - high dose, placebo - high dose||2.4|1.0|0.06
71805491|NCT01380327|143111356|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.4||||0.13|TWO_SIDED|95.0|0.9|2.2|||Mixed Models Analysis||Estimated value \& associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).|Analysis compared cockroach SLIT - low dose, placebo - low dose||2.2|0.9|0.13
71805492|NCT01380327|143111357|SUPERIORITY_OR_OTHER||Treatment effect|-12.9||||0.21|TWO_SIDED|95.0|-33.2|7.5|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - high dose, placebo - high dose||7.5|-33.2|0.21
71805493|NCT01380327|143111357|SUPERIORITY_OR_OTHER||Treatment effect|13.5||||0.2|TWO_SIDED|95.0|-7.1|34.1|||Mixed Models Analysis||Estimated value\& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - low dose, placebo - low dose||34.1|-7.1|0.20
71805494|NCT04313634|143111395|SUPERIORITY|||||||0.611|||||||Wilcoxon (Mann-Whitney)|||||||0.611
71805495|NCT04313634|143111396|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71805496|NCT04313634|143111397|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71805497|NCT04313634|143111398|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
71805498|NCT04313634|143111400|SUPERIORITY|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
71675596|NCT01073605|142868654|SUPERIORITY_OR_OTHER|||||||0.16421|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.16421
71675597|NCT01073605|142868658|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.0001
71805499|NCT01587651|143111405|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.|Mean Difference (Final Values)|46.0|STANDARD_ERROR_OF_MEAN|10.66|||TWO_SIDED|95.0|24.9|67.2||||||ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.||67.2|24.9|
71805500|NCT01660763|143111445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.59|STANDARD_ERROR_OF_MEAN|10.88|<|0.001|TWO_SIDED|95.0|66.2|108.98|||ANCOVA|||||108.98|66.20|<0.001
71805501|NCT03325712|143111447|OTHER||Slope|0.8188|STANDARD_ERROR_OF_MEAN|0.0725|||TWO_SIDED|90.0|0.6966|0.941|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9410|0.6966|
71805502|NCT03325712|143111448|OTHER||Slope|0.7708|STANDARD_ERROR_OF_MEAN|0.0747|||TWO_SIDED|90.0|0.6449|0.8967|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.8967|0.6449|
71805503|NCT03325712|143111449|OTHER||Slope|0.7167|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|90.0|0.4922|0.9412|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9412|0.4922|
71805504|NCT03325712|143111450|OTHER||Slope|0.6825|STANDARD_ERROR_OF_MEAN|0.1344|||TWO_SIDED|90.0|0.4556|0.9094|||||Based on the estimate for slope parameter (β), a 2-sided 90% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of mean is standard error of slope.|The basic model for the investigation of dose proportionality is a power model that describes the functional relationship between the dose and PK endpoints. Statistical hypotheses were not tested in a confirmatory sense.||0.9094|0.4556|
71805505|NCT03325712|143111451|OTHER||Ratio (T/R)|102.81|STANDARD_DEVIATION|17.5|||TWO_SIDED|90.0|87.18|121.25||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||121.25|87.18|
71805506|NCT03325712|143111451|OTHER||Ratio (T/R)|93.06|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|79.94|108.32||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||108.32|79.94|
71805507|NCT03325712|143111451|OTHER||Ratio (T/R)|109.82|STANDARD_DEVIATION|5.0|||TWO_SIDED|90.0|103.59|116.42||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||116.42|103.59|
71805508|NCT03325712|143111451|OTHER||Ratio ( T/R)|108.37|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|92.0|127.66||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||127.66|92.00|
71842170|NCT03988621|143195725|SUPERIORITY||Mean Difference (Final Values)|1.3472||||0.5433|TWO_SIDED|95.0|0.5153|3.5218|||Regression, zero inflated poisson||Estimation accounts for the zero-inflated distribution of hospitalization count, thus estimate is inconsistent with mean values in the Outcome Measure Data table|||3.5218|0.5153|0.5433
71842171|NCT03988621|143195726|SUPERIORITY||Mean Difference (Final Values)|1.0143||||0.9173|TWO_SIDED|95.0|0.7766|1.3247|||Zero-inflated poisson regression|||||1.3247|0.7766|0.9173
71842172|NCT03988621|143195727|SUPERIORITY|||||||0.6486|||||||Fisher Exact|||||||0.6486
71675598|NCT01073605|142868658|SUPERIORITY_OR_OTHER|||||||0.58324|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||0.58324
71675599|NCT01073605|142868658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years||||<0.0001
71805509|NCT03325712|143111451|OTHER||Ratio (T/R)|109.11|STANDARD_DEVIATION|17.6|||TWO_SIDED|90.0|92.43|128.79||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||128.79|92.43|
71805510|NCT03325712|143111452|OTHER||Ratio (T/R)|100.1|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|83.99|119.31||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"Placebo matching BI 705564. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||119.31|83.99|
71805511|NCT03325712|143111452|OTHER||Ratio (T/R)|84.43|STANDARD_DEVIATION|16.5|||TWO_SIDED|90.0|72.29|98.62||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 2. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||98.62|72.29|
71805512|NCT03325712|143111452|OTHER||Ratio (T/R)|109.41|STANDARD_DEVIATION|13.1|||TWO_SIDED|90.0|94.34|126.88||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 3. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||126.88|94.34|
71805513|NCT03325712|143111452|OTHER||Ratio (T/R)|95.44|STANDARD_DEVIATION|19.1|||TWO_SIDED|90.0|79.75|114.21||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 5. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.21|79.75|
71805514|NCT03325712|143111452|OTHER||Ratio (T/R)|90.04|STANDARD_DEVIATION|25.9|||TWO_SIDED|90.0|70.75|114.59||||Standard deviation is intra-individual geometric coefficient of variation (%).|The effect of BI 705564 on midazolam is estimated by the ratio of the geometric mean (T/R) and confidence interval (CI). CI is calculated based on the residual error from ANOVA.|"BI 705564 dose group 4. Relative bioavailability of midazolam is analyzed using analysis of variance (ANOVA) model on logarithmic scale including random effects for subjects and fixed effects for time point."||114.59|70.75|
71805515|NCT00952653|143111453|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|71.4|||||TWO_SIDED|90.0|65.08|78.33|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||78.33|65.08|
71805516|NCT00952653|143111454|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|86.08|||||TWO_SIDED|90.0|79.04|93.74|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||93.74|79.04|
71805517|NCT00952653|143111455|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|92.55|||||TWO_SIDED|90.0|87.43|97.97|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||97.97|87.43|
71805518|NCT00952653|143111456|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|101.17|||||TWO_SIDED|90.0|92.96|110.11|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction \[that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam\], where overall study power is to be based on the product of the individual powers of the parameters of interest.||110.11|92.96|
71805519|NCT00952653|143111457|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|72.1|||||TWO_SIDED|90.0|66.04|78.72|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||78.72|66.04|
71805520|NCT00952653|143111460|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|87.39|||||TWO_SIDED|90.0|80.42|94.96|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)||94.96|80.42|
71805521|NCT02265237|143111463|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|100.0|||||TWO_SIDED|97.5|92.4|100.0|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||100.0|92.4|
71675600|NCT01073605|142868663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.0681|TWO_SIDED|95.0|-0.05|1.39||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||1.39|-0.05|0.0681
71675601|NCT01073605|142868663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.8971|TWO_SIDED|95.0|-0.65|0.74||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.74|-0.65|0.8971
71805522|NCT02265237|143111463|SUPERIORITY|97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.|Percentage of Participants|96.6|||||TWO_SIDED|97.5|86.7|99.2|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||99.2|86.7|
71805523|NCT02265237|143111463|SUPERIORITY|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|93.4|||||TWO_SIDED|97.5|82.6|97.7|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.||97.7|82.6|
71805524|NCT02265237|143111464|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|-3.39||||0.304|TWO_SIDED|95.0|-9.85|3.07|||Mantel Haenszel|||Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.||3.07|-9.85|0.304
71805525|NCT02265237|143111465|SUPERIORITY|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|6.45||||0.086|TWO_SIDED|95.0|-0.91|13.81|||Mantel Haenszel|||Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.||13.81|-0.91|0.086
71805526|NCT00839072|143111489|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax does not exceed 125%.|Ratio of the mean|59.66|||||TWO_SIDED|90.0|50.99|69.81|||||Trazodone Contramid® OAD/Desyrel®|||69.81|50.99|
71842173|NCT03988621|143195728|SUPERIORITY|||||||0.6791|||||||t-test, 2 sided|||||||0.6791
71842174|NCT01447719|143195741|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|92.0|||||TWO_SIDED|95.0|78.0|98.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a positive scan based on majority of 5 blinded readers||98|78|
71842175|NCT01447719|143195742|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|80.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|80|
71842176|NCT01447719|143195743|SUPERIORITY_OR_OTHER_LEGACY||Correlation coefficient|0.76|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|0.62|0.85||A one-sided test (rho \> 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|Asymptotic standard error and 95 percent CI used Fisher z-transformation.||Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.||0.85|0.62|<0.0001
71842177|NCT01447719|143195744|SUPERIORITY_OR_OTHER_LEGACY||Sensitivity|96.0|||||TWO_SIDED|95.0|80.0|100.0||||||Proportion of subjects who had a positive scan based on majority of 5 blinded readers||100|80|
71675602|NCT01073605|142868663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.0583|TWO_SIDED|95.0|-1.27|0.02||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.||||0.02|-1.27|0.0583
71842178|NCT01447719|143195745|SUPERIORITY_OR_OTHER_LEGACY||Specificity|100.0|||||TWO_SIDED|95.0|78.0|100.0||||||Proportion of subjects who had a negative scan based on majority of 5 blinded readers||100|78|
71842179|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|2.19||||0.853|TWO_SIDED|95.0|-21.16|25.54||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||25.54|-21.16|0.853
71842180|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|5.04||||0.767|TWO_SIDED|95.0|-28.57|38.65||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.30|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||38.65|-28.57|0.767
71675603|NCT00083759|142868668|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||Cochran-Mantel-Haenszel|||||||0.089
71675604|NCT00083759|142868669|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Cochran-Mantel-Haenszel|||||||0.171
71675605|NCT00083759|142868670|SUPERIORITY_OR_OTHER|||||||0.526||95.0|||||Cochran-Mantel-Haenszel|||||||0.526
71675606|NCT00267969|142868692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71675607|NCT00267969|142868692|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control for the multiplicity for the primary endpoint analysis, the Holm's procedure was used at an overall significance level of 0.05|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight \[\<=90kg vs \> 90 kg). For all the scenarios evaluated, the power is \>99% at an overall significance level of 0.05.||||<0.001
71675608|NCT00267969|142868693|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel(CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71675609|NCT00267969|142868693|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
71805527|NCT00839072|143111490|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCT is between 80% and 125%.|Ratio of the mean|78.55|||||TWO_SIDED|90.0|69.7|88.51|||||Trazodone Contramid® OAD/Desyrel®|||88.51|69.70|
71805528|NCT00839072|143111491|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC∞ is between 80% and 125%.|Ratio of the mean|80.05|||||TWO_SIDED|90.0|70.67|90.68|||||Trazodone Contramid® OAD/Desyrel®|||90.68|70.67|
71805529|NCT00380068|143111495|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.5|STANDARD_DEVIATION|65.64|<|0.001||95.0|11.8|29.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||29.3|11.8|<0.001
71805530|NCT00380068|143111496|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_DEVIATION|2.11|<|0.001||95.0|-0.8|-0.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||-0.3|-0.8|<0.001
71805531|NCT00380068|143111497|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.001||95.0|-1.0|-0.2|||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||-0.2|-1.0|0.001
71805532|NCT00380068|143111498|SUPERIORITY_OR_OTHER||Percent change from baseline|-25.5||||||95.0|-33.6|-16.3|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.3|-33.6|
71805533|NCT00380068|143111499|SUPERIORITY_OR_OTHER||Percent change from baseline|-29.2||||||95.0|-39.8|-16.6|||||Percent change from baseline derived from Geometric Mean Ratio|||-16.6|-39.8|
71842181|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|2.84||||0.868|TWO_SIDED|95.0|-30.93|36.62||Unadjusted p-value|Mixed Models Analysis|t (df,112) = 0.17|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||36.62|-30.93|0.868
71842182|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.96|TWO_SIDED|95.0|-24.26|25.52||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.05|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||25.52|-24.26|0.960
71805534|NCT00380068|143111500|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
71805535|NCT00380068|143111501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test|||||||<0.001
71675610|NCT00267969|142868694|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||||||<0.001
71805536|NCT00380068|143111502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 24||||||<0.001
71805537|NCT00380068|143111503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Paired t-test on change from Baseline to Week 48||||||<0.001
71675611|NCT00267969|142868694|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm's procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs \> 90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.||||<0.001
71805538|NCT00380068|143111504|SUPERIORITY_OR_OTHER||percent event free|89.4||||||95.0|84.4|92.8|||||Estimate obtained through Kaplan-Meier methods|||92.8|84.4|
71805539|NCT00380068|143111505|SUPERIORITY_OR_OTHER||percent event free|84.1||||||95.0|78.2|88.6|||||Estimate obtained through Kaplan-Meier methods|||88.6|78.2|
71805540|NCT00380068|143111506|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.4|97.4|||||Estimate obtained through Kaplan-Meier methods|||97.4|91.4|
71805541|NCT00380068|143111507|SUPERIORITY_OR_OTHER||percent event free|92.9||||||95.0|88.3|95.8|||||Estimate obtained through Kaplan-Meier methods|||95.8|88.3|
71805542|NCT00380068|143111508|SUPERIORITY_OR_OTHER||percent event free|95.0||||||95.0|88.5|97.9|||||Estimate obtained through Kaplan-Meier methods|||97.9|88.5|
71805543|NCT00380068|143111509|SUPERIORITY_OR_OTHER||percent event free|90.0||||||95.0|81.6|94.7|||||Estimate obtained through Kaplan-Meier methods|||94.7|81.6|
71805544|NCT00380068|143111510|SUPERIORITY_OR_OTHER||percent event free|97.1||||||95.0|93.6|98.7|||||Estimate obtained through Kaplan-Meier methods|||98.7|93.6|
71842183|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|8.42||||0.63|TWO_SIDED|95.0|-25.97|42.82||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.48|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.82|-25.97|0.630
71894389|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.56|||||TWO_SIDED|95.0|0.38|0.82||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.38|
71894390|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.74|||||TWO_SIDED|95.0|0.59|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.59|
71894391|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|1.23|||||TWO_SIDED|95.0|0.92|1.65||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.65|0.92|
71805545|NCT00380068|143111511|SUPERIORITY_OR_OTHER||percent event free|95.3||||||95.0|91.2|97.6|||||Estimate obtained through Kaplan-Meier methods|||97.6|91.2|
71805546|NCT01297062|143111512|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.36|||||TWO_SIDED|90.0|-2.21|-0.5||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.50|-2.21|
71805547|NCT01297062|143111513|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-2.02|||||TWO_SIDED|90.0|-2.88|-1.16||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-1.16|-2.88|
71805548|NCT01297062|143111514|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.13|||||TWO_SIDED|90.0|-2.11|-0.15||No adjustment on CI for the primary outcome measure.|Mixed Models Analysis||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.||-0.15|-2.11|
71805549|NCT01297062|143111515|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.47|||||TWO_SIDED|90.0|2.82|8.12|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||8.12|2.82|
71842184|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|7.79||||0.657|TWO_SIDED|95.0|-26.77|42.36||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = 0.44|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||42.36|-26.77|0.657
71894392|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|1.0|||||TWO_SIDED|95.0|0.8|1.25||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.25|0.80|
71894393|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.72|||||TWO_SIDED|95.0|0.58|0.9||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.58|
71842185|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|-5.08||||0.627|TWO_SIDED|95.0|-25.72|15.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.56|-25.72|0.627
71894394|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.64|||||TWO_SIDED|95.0|0.47|0.86||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.47|
71894395|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.7|||||TWO_SIDED|95.0|0.55|0.89||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.89|0.55|
71894396|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.96|||||TWO_SIDED|95.0|0.77|1.19||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.19|0.77|
71675612|NCT00267969|142868695|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71842186|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.364|TWO_SIDED|95.0|-42.86|15.86||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.91|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||15.86|-42.86|0.364
71805550|NCT01297062|143111516|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.56|||||TWO_SIDED|90.0|8.46|12.67|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||12.67|8.46|
71805551|NCT01297062|143111517|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|10.92|||||TWO_SIDED|90.0|8.71|13.13|||Mixed Models Analysis||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.||13.13|8.71|
71805552|NCT01297062|143111520|SUPERIORITY_OR_OTHER||Slope|0.0008||||0.5962|TWO_SIDED|90.0|-0.0017|0.0033|||Mixed Models Analysis||The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.|The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.||0.0033|-0.0017|0.5962
71805553|NCT01458574|143111521|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||31.2|15.3|<0.0001
71805554|NCT01458574|143111521|SUPERIORITY_OR_OTHER||Difference in percentage|29.5|||<|0.0001|TWO_SIDED|95.0|21.4|37.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.6|21.4|<0.0001
71894397|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
71675613|NCT00267969|142868695|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||||||<0.001
71894398|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.61|||||TWO_SIDED|95.0|0.45|0.82||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.45|
71842187|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|-8.42||||0.574|TWO_SIDED|95.0|-38.0|21.15||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||21.15|-38.00|0.574
71842188|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|-5.51||||0.557|TWO_SIDED|95.0|-23.96|12.94||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.94|-23.96|0.557
71894399|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.71|||||TWO_SIDED|95.0|0.57|0.88||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.57|
71675614|NCT00267969|142868695|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight \[≤ 90kg vs \> 90 kg)\].||Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.||||0.001
71675615|NCT01309360|142868705|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71675616|NCT01309360|142868705|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71675617|NCT01309360|142868705|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71842189|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|-13.65||||0.302|TWO_SIDED|95.0|-39.64|12.35||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -1.03|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||12.35|-39.64|0.302
71675618|NCT01309360|142868706|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Kruskal-Wallis|||||||0
71675619|NCT01309360|142868707|SUPERIORITY_OR_OTHER|||||||0.059||95.0|||||Fisher Exact|||||||0.059
71805555|NCT01458574|143111522|SUPERIORITY_OR_OTHER||Difference in percentage|24.2|||<|0.0001|TWO_SIDED|95.0|16.0|32.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.5|16.0|<0.0001
71805556|NCT01458574|143111522|SUPERIORITY_OR_OTHER||Difference in percentage|32.6|||<|0.0001|TWO_SIDED|95.0|24.2|41.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.0|24.2|<0.0001
71805557|NCT01458574|143111523|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|17.4|43.2|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.2|17.4|<0.0001
71805558|NCT01458574|143111523|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
71842190|NCT02938923|143195814|SUPERIORITY||Mean Difference (Final Values)|-8.14||||0.541|TWO_SIDED|95.0|-34.33|18.06||Unadjusted p-value|Mixed Models Analysis|t (df, 217) = -0.61|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||18.06|-34.33|0.541
71842191|NCT02938923|143195815|SUPERIORITY||Mean Difference (Final Values)|357.72||||0.336|TWO_SIDED|95.0|-375.75|1091.19||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.97|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1091.19|-375.75|0.336
71675620|NCT01309360|142868707|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71675621|NCT01309360|142868707|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
71675622|NCT01309360|142868708|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Fisher Exact|||||||0.675
71675623|NCT01309360|142868708|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
71675624|NCT01309360|142868708|SUPERIORITY_OR_OTHER|||||||0.348||95.0|||||Fisher Exact|||||||0.348
71675625|NCT01309360|142868709|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.247
71675626|NCT01309360|142868709|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71675627|NCT01309360|142868709|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71675628|NCT01309360|142868710|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
71675629|NCT01309360|142868710|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
71675630|NCT01309360|142868710|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1
71675631|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.31||||0.0025|TWO_SIDED|90.0|0.17|0.57|||t-test, 2 sided|||||0.57|0.17|0.0025
71675632|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|0.74||||0.454|TWO_SIDED|90.0|0.38|1.45|||t-test, 2 sided|||||1.45|0.38|0.4540
71675633|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|4.69||||0.0003|TWO_SIDED|90.0|2.46|8.94|||t-test, 2 sided|||||8.94|2.46|0.0003
71675634|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|2.22||||0.046|TWO_SIDED|90.0|1.16|4.24|||t-test, 2 sided|||||4.24|1.16|0.0460
71675635|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.76||||0.3365|TWO_SIDED|90.0|0.47|1.22|||t-test, 2 sided|||||1.22|0.47|0.3365
71675636|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.56||||0.0313|TWO_SIDED|90.0|0.37|0.87|||t-test, 2 sided|||||0.87|0.37|0.0313
71675637|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.08||||0.806|TWO_SIDED|90.0|0.65|1.79|||t-test, 2 sided|||||1.79|0.65|0.8060
71675638|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|1.74||||0.2044|TWO_SIDED|90.0|0.84|3.58|||t-test, 2 sided|||||3.58|0.84|0.2044
71675639|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|1.67||||0.149|TWO_SIDED|90.0|0.93|3.02|||t-test, 2 sided|||||3.02|0.93|0.1490
71805559|NCT01458574|143111524|SUPERIORITY_OR_OTHER||Difference in percentage|22.7|||<|0.0001|TWO_SIDED|95.0|14.8|30.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||30.6|14.8|<0.0001
71805560|NCT01458574|143111524|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
71805561|NCT01458574|143111525|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
71805562|NCT01458574|143111525|SUPERIORITY_OR_OTHER||Difference in percentage|20.3|||<|0.0001|TWO_SIDED|95.0|13.5|27.1|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.1|13.5|<0.0001
71805563|NCT01458574|143111526|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||<|0.0001|TWO_SIDED|95.0|18.1|35.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.5|18.1|<0.0001
71805564|NCT01458574|143111526|SUPERIORITY_OR_OTHER||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|20.3|37.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||37.7|20.3|<0.0001
71805565|NCT01458574|143111527|SUPERIORITY_OR_OTHER||Difference in percentage|21.2|||<|0.0001|TWO_SIDED|95.0|14.1|28.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||28.3|14.1|<0.0001
71805566|NCT01458574|143111527|SUPERIORITY_OR_OTHER||Difference in percentage|26.4|||<|0.0001|TWO_SIDED|95.0|19.0|33.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||33.8|19.0|<0.0001
71805567|NCT01458574|143111528|SUPERIORITY_OR_OTHER||Difference in percentage|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||43.1|18.1|<0.0001
71842192|NCT02938923|143195815|SUPERIORITY||Mean Difference (Final Values)|936.93||||0.09|TWO_SIDED|95.0|-147.56|2021.42||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.71|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2021.42|-147.56|0.090
71805568|NCT01458574|143111528|SUPERIORITY_OR_OTHER||Difference in percentage|44.5|||<|0.0001|TWO_SIDED|95.0|31.8|57.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||57.2|31.8|<0.0001
71805569|NCT01458574|143111528|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|18.7|41.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||41.4|18.7|<0.0001
71805570|NCT01458574|143111528|SUPERIORITY_OR_OTHER||Difference in percentage|43.2|||<|0.0001|TWO_SIDED|95.0|31.1|55.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|31.1|<0.0001
71842193|NCT02938923|143195815|SUPERIORITY||Mean Difference (Final Values)|579.21||||0.297|TWO_SIDED|95.0|-515.36|1673.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.05|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1673.78|-515.36|0.297
71675640|NCT02308540|142868718|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|1.13||||0.7565|TWO_SIDED|90.0|0.59|2.15|||t-test, 2 sided|||||2.15|0.59|0.7565
71675641|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 1 GMC Ratio|0.75||||0.2653|TWO_SIDED|90.0|0.54|1.31|||Two-tailed from z-test|||||1.31|0.54|0.2653
71842194|NCT02938923|143195815|SUPERIORITY||Mean Difference (Final Values)|383.36||||0.245|TWO_SIDED|95.0|-266.06|1032.79||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1032.79|-266.06|0.245
71842195|NCT02938923|143195815|SUPERIORITY||Mean Difference (Final Values)|836.64||||0.069|TWO_SIDED|95.0|-67.04|1740.32||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1740.32|-67.04|0.069
71842196|NCT02938923|143195815|SUPERIORITY||Mean Difference (Final Values)|453.28||||0.327|TWO_SIDED|95.0|-459.13|1365.68||Unadjusted p-value|Mixed Models Analysis|t (df, 107) = 0.98|Difference between changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1365.68|-459.13|0.327
71805571|NCT01458574|143111529|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|13.8|35.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||35.0|13.8|<0.0001
71805572|NCT01458574|143111529|SUPERIORITY_OR_OTHER||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|28.7|52.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||52.3|28.7|<0.0001
71805573|NCT01458574|143111530|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001|TWO_SIDED|95.0|20.9|39.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||39.7|20.9|<0.0001
71805574|NCT01458574|143111530|SUPERIORITY_OR_OTHER||Difference in percentage|37.2|||<|0.0001|TWO_SIDED|95.0|28.1|46.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||46.4|28.1|<0.0001
71805575|NCT01458574|143111530|SUPERIORITY_OR_OTHER||Difference in percentage|31.3|||<|0.0001|TWO_SIDED|95.0|22.4|40.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||40.2|22.4|<0.0001
71805576|NCT01458574|143111530|SUPERIORITY_OR_OTHER||Difference in percentage|41.7|||<|0.0001|TWO_SIDED|95.0|32.9|50.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.5|32.9|<0.0001
71805577|NCT01458574|143111531|SUPERIORITY_OR_OTHER||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|20.9|38.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.7|20.9|<0.0001
71805578|NCT01458574|143111531|SUPERIORITY_OR_OTHER||Difference in percentage|40.2|||<|0.0001|TWO_SIDED|95.0|31.4|49.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||49.0|31.4|<0.0001
71805579|NCT01458574|143111532|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
71805580|NCT01458574|143111532|SUPERIORITY_OR_OTHER||Difference in percentage|24.4|||<|0.0001|TWO_SIDED|95.0|16.4|32.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||32.4|16.4|<0.0001
71805581|NCT01458574|143111532|SUPERIORITY_OR_OTHER||Difference in percentage|23.2|||<|0.0001|TWO_SIDED|95.0|15.3|31.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||31.2|15.3|<0.0001
71805582|NCT01458574|143111532|SUPERIORITY_OR_OTHER||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|21.9|38.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||38.2|21.9|<0.0001
71805583|NCT01458574|143111533|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.7|10.6|<0.0001
71805584|NCT01458574|143111533|SUPERIORITY_OR_OTHER||Difference in percentage|20.8|||<|0.0001|TWO_SIDED|95.0|14.0|27.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.7|14.0|<0.0001
71805585|NCT01458574|143111534|SUPERIORITY_OR_OTHER||Difference in percentage|10.1||||0.0006|TWO_SIDED|95.0|4.5|15.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|4.5|0.0006
71805586|NCT01458574|143111534|SUPERIORITY_OR_OTHER||Difference in percentage|6.6||||0.0092|TWO_SIDED|95.0|1.5|11.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.7|1.5|0.0092
71805587|NCT01458574|143111534|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
71805588|NCT01458574|143111534|SUPERIORITY_OR_OTHER||Difference in percentage|11.2|||<|0.0001|TWO_SIDED|95.0|5.5|16.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.9|5.5|<0.0001
71805589|NCT01458574|143111535|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
71805590|NCT01458574|143111535|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.035|TWO_SIDED|95.0|0.3|5.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||5.8|0.3|0.0350
71842197|NCT02938923|143195816|SUPERIORITY||Mean Difference (Final Values)|17.16||||0.934|TWO_SIDED|95.0|-391.74|426.05||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.08|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||426.05|-391.74|0.934
71842198|NCT02938923|143195816|SUPERIORITY||Mean Difference (Final Values)|562.64||||0.068|TWO_SIDED|95.0|-42.02|1167.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.84|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1167.31|-42.02|0.068
71842199|NCT02938923|143195816|SUPERIORITY||Mean Difference (Final Values)|545.49||||0.079|TWO_SIDED|95.0|-64.81|1155.79||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1155.79|-64.81|0.079
71842200|NCT02938923|143195816|SUPERIORITY||Mean Difference (Final Values)|33.73||||0.867|TWO_SIDED|95.0|-365.4|432.86||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 0.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||432.860|-365.40|0.867
71842201|NCT02938923|143195816|SUPERIORITY||Mean Difference (Final Values)|665.75||||0.02|TWO_SIDED|95.0|105.68|1225.81||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.36|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1225.81|105.68|0.020
71842202|NCT02938923|143195816|SUPERIORITY||Mean Difference (Final Values)|632.02||||0.029|TWO_SIDED|95.0|66.38|1197.66||Unadjusted p-value|Mixed Models Analysis|t (df, 102) = 2.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||1197.66|66.38|0.029
71805591|NCT01458574|143111536|SUPERIORITY_OR_OTHER||Difference in percentage|17.2|||<|0.0001|TWO_SIDED|95.0|10.3|24.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.0|10.3|<0.0001
71842203|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.946|TWO_SIDED|95.0|-19.61|21.01||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 0.07|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||21.01|-19.61|0.946
71842204|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|24.44||||0.094|TWO_SIDED|95.0|-4.25|53.13||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.69|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||53.13|-4.25|0.094
71842205|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|23.74||||0.107|TWO_SIDED|95.0|-5.19|52.67||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||52.67|-5.19|0.107
71805592|NCT01458574|143111536|SUPERIORITY_OR_OTHER||Difference in percentage|15.3|||<|0.0001|TWO_SIDED|95.0|8.5|22.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.0|8.5|<0.0001
71842206|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|4.81||||0.627|TWO_SIDED|95.0|-14.68|24.3||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 0.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||24.30|-14.68|0.627
71805593|NCT01458574|143111536|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||<|0.0001|TWO_SIDED|95.0|8.8|22.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||22.5|8.8|<0.0001
71805594|NCT01458574|143111536|SUPERIORITY_OR_OTHER||Difference in percentage|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|27.0|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.0|12.7|<0.0001
71805595|NCT01458574|143111537|SUPERIORITY_OR_OTHER||Difference in percentage|11.1|||<|0.0001|TWO_SIDED|95.0|5.9|16.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.4|5.9|<0.0001
71805596|NCT01458574|143111537|SUPERIORITY_OR_OTHER||Difference in percentage|13.2|||<|0.0001|TWO_SIDED|95.0|7.7|18.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.7|7.7|<0.0001
71805597|NCT01458574|143111538|SUPERIORITY_OR_OTHER||Difference in percentage|12.1|||<|0.0001|TWO_SIDED|95.0|6.3|17.9|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||17.9|6.3|<0.0001
71805598|NCT01458574|143111538|SUPERIORITY_OR_OTHER||Difference in percentage|8.1||||0.0021|TWO_SIDED|95.0|2.8|13.5|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||13.5|2.8|0.0021
71805599|NCT01458574|143111538|SUPERIORITY_OR_OTHER||Difference in percentage|10.6||||0.0004|TWO_SIDED|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.2|5.0|0.0004
71805600|NCT01458574|143111538|SUPERIORITY_OR_OTHER||Difference in percentage|12.7|||<|0.0001|TWO_SIDED|95.0|6.8|18.6|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.6|6.8|<0.0001
71805601|NCT01458574|143111539|SUPERIORITY_OR_OTHER||Difference in percentage|5.6||||0.0029|TWO_SIDED|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||9.0|2.1|0.0029
71805602|NCT01458574|143111539|SUPERIORITY_OR_OTHER||Difference in percentage|4.6||||0.0064|TWO_SIDED|95.0|1.4|7.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||7.8|1.4|0.0064
71805603|NCT01458574|143111541|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.9|||Linear mixed effect model|||At Week 24||-1.9|-3.2|<0.0001
71805604|NCT01458574|143111541|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.8|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.2|||Linear mixed effect model|||At Week 24||-2.2|-3.5|<0.0001
71805605|NCT01458574|143111541|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.7|||Linear mixed effect model|||At Week 52||-1.7|-3.4|<0.0001
71805606|NCT01458574|143111541|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.3|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.5|||Linear mixed effect model|||At Week 52||-2.5|-4.1|<0.0001
71805607|NCT01458574|143111542|SUPERIORITY_OR_OTHER||Difference in percentage|40.1|||<|0.0001|TWO_SIDED|95.0|25.0|55.3|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||55.3|25.0|<0.0001
71842207|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|24.91||||0.072|TWO_SIDED|95.0|-2.2|52.01||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.81|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||52.01|-2.20|0.072
71805608|NCT01458574|143111542|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
71805609|NCT01458574|143111542|SUPERIORITY_OR_OTHER||Difference in percentage|36.0|||<|0.0001|TWO_SIDED|95.0|21.6|50.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||50.3|21.6|<0.0001
71805610|NCT01458574|143111542|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
71805611|NCT01458574|143111543|SUPERIORITY_OR_OTHER||Difference in percentage|31.8|||<|0.0001|TWO_SIDED|95.0|18.8|44.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||44.8|18.8|<0.0001
71805612|NCT01458574|143111543|SUPERIORITY_OR_OTHER||Difference in percentage|42.2|||<|0.0001|TWO_SIDED|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||56.5|27.9|<0.0001
71842208|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|20.1||||0.149|TWO_SIDED|95.0|-7.29|47.49||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||47.49|-7.29|0.149
71842209|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|-1.38||||0.849|TWO_SIDED|95.0|-15.71|12.95||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = -0.19|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||12.95|-15.71|0.849
71842210|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|15.47||||0.134|TWO_SIDED|95.0|-4.83|35.78||Unadjusted p-value|Mixed Models Analysis|(df, 110) = 1.15|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||35.78|-4.83|0.134
71842211|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|16.86||||0.107|TWO_SIDED|95.0|-3.68|37.39||Unadjusted p-value|Mixed Models Analysis|t (df, 110) = 1.63|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||37.39|-3.68|0.107
71842212|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.973|TWO_SIDED|95.0|-13.64|13.17||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = -0.03|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||13.17|-13.64|0.973
71842213|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|14.49||||0.135|TWO_SIDED|95.0|-4.56|33.54||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.50|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||33.54|-4.56|0.135
71842214|NCT02938923|143195817|SUPERIORITY||Mean Difference (Final Values)|14.72||||0.134|TWO_SIDED|95.0|-4.55|34.0||Unadjusted p-value|Mixed Models Analysis|t (df, 189) = 1.51|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||34.00|-4.55|0.134
71842215|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|1.21||||0.125|TWO_SIDED|95.0|-0.34|2.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.55|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.76|-0.34|0.125
71842216|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.758|TWO_SIDED|95.0|-1.9|2.61||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||2.61|-1.90|0.758
71842217|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|-0.86||||0.455|TWO_SIDED|95.0|-3.12|1.41||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.75|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.41|-3.12|0.455
71842218|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.229|TWO_SIDED|95.0|-0.72|3.0||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 1.21|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.00|-0.72|0.229
71842219|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.647|TWO_SIDED|95.0|-1.97|3.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.46|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||3.16|-1.97|0.647
71842220|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.68|TWO_SIDED|95.0|-3.12|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.41|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.04|-3.12|0.680
71842221|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.052|TWO_SIDED|95.0|-0.02|2.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 1.96|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.97|-0.02|0.052
71842222|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.754|TWO_SIDED|95.0|-1.79|2.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.31|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||2.46|-1.79|0.754
71842223|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|-1.14||||0.294|TWO_SIDED|95.0|-3.28|1.0||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.06|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.00|-3.28|0.294
71842224|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|1.46||||0.031|TWO_SIDED|95.0|0.13|2.78||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.17|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.78|0.13|0.031
71675642|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 5 GMC Ratio|0.69||||0.2059|TWO_SIDED|90.0|0.45|1.2|||Two-tailed from z-test|||||1.20|0.45|0.2059
71675643|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6A GMC Ratio|0.84||||0.5664|TWO_SIDED|90.0|0.55|1.54|||Two-tailed from z-test|||||1.54|0.55|0.5664
71675644|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6B GMC Ratio|0.82||||0.4456|TWO_SIDED|90.0|0.57|1.31|||Two-tailed from z-test|||||1.31|0.57|0.4456
71675645|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 7F GMC Ratio|0.74||||0.2189|TWO_SIDED|90.0|0.52|1.14|||Two-tailed from z-test|||||1.14|0.52|0.2189
71675646|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 9V GMC Ratio|0.6||||0.097|TWO_SIDED|90.0|0.38|1.03|||Two-tailed from z-test|||||1.03|0.38|0.0970
71805613|NCT01458574|143111544|SUPERIORITY_OR_OTHER||Difference in percentage|38.6|||<|0.0001|TWO_SIDED|95.0|23.4|53.8|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||53.8|23.4|<0.0001
71805614|NCT01458574|143111544|SUPERIORITY_OR_OTHER||Difference in percentage|48.4|||<|0.0001|TWO_SIDED|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||64.1|32.7|<0.0001
71805615|NCT01458574|143111544|SUPERIORITY_OR_OTHER||Difference in percentage|34.4|||<|0.0001|TWO_SIDED|95.0|20.1|48.8|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||48.8|20.1|<0.0001
71805616|NCT01458574|143111544|SUPERIORITY_OR_OTHER||Difference in percentage|46.2|||<|0.0001|TWO_SIDED|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||61.4|31.0|<0.0001
71805617|NCT01458574|143111545|SUPERIORITY_OR_OTHER||Difference in percentage|12.9||||0.0074|TWO_SIDED|95.0|2.6|23.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.2|2.6|0.0074
71805618|NCT01458574|143111545|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0103|TWO_SIDED|95.0|2.4|24.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|2.4|0.0103
71805619|NCT01458574|143111545|SUPERIORITY_OR_OTHER||Difference in percentage|16.8||||0.0018|TWO_SIDED|95.0|6.2|27.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.5|6.2|0.0018
71805620|NCT01458574|143111545|SUPERIORITY_OR_OTHER||Difference in percentage|16.7||||0.0029|TWO_SIDED|95.0|5.5|27.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||27.9|5.5|0.0029
71675647|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 14 GMC Ratio|1.76||||0.0713|TWO_SIDED|90.0|1.02|2.79|||Two-tailed from z-test|||||2.79|1.02|0.0713
71675648|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19A GMC Ratio|0.71||||0.3443|TWO_SIDED|90.0|0.42|1.35|||Two-tailed from z-test|||||1.35|0.42|0.3443
71675649|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19F GMC Ratio|0.76||||0.3278|TWO_SIDED|90.0|0.48|1.23|||Two-tailed from z-test|||||1.23|0.48|0.3278
71805621|NCT01458574|143111546|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.0419|TWO_SIDED|95.0|0.1|15.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||15.7|0.1|0.0419
71675650|NCT02308540|142868719|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 23F GMC Ratio|0.65||||0.2039|TWO_SIDED|90.0|0.4|1.16|||Two-tailed from z-test|||||1.16|0.40|0.2039
71675651|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.89||||0.255|TWO_SIDED|90.0|0.74|1.06|||t-test, 2 sided|||||1.06|0.74|0.2550
71805622|NCT01458574|143111546|SUPERIORITY_OR_OTHER||Difference in percentage|11.1||||0.0121|TWO_SIDED|95.0|2.3|19.9|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||19.9|2.3|0.0121
71805623|NCT04964089|143111580|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin (NI) is 4.5 letters.|Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.91||0.0083|TWO_SIDED|95.03|-3.88|-0.29|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA as covariates.||||-0.29|-3.88|0.0083
71805624|NCT01682837|143111587|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71805625|NCT01682837|143111588|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71805626|NCT01682837|143111589|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||||||0.16
71805627|NCT01682837|143111590|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71805628|NCT01682837|143111591|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Models Analysis|||||||0.42
71805629|NCT01682837|143111592|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mixed Models Analysis|||||||0.10
71805630|NCT01682837|143111593|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
71805631|NCT01682837|143111594|SUPERIORITY_OR_OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
71805632|NCT01682837|143111595|SUPERIORITY_OR_OTHER|||||||0.12|||||||Mixed Models Analysis|||||||0.12
71805633|NCT05437510|143111596|SUPERIORITY||Efficacy|84.04|||<|0.0001|TWO_SIDED|95.0|69.493|92.411|||Exact method using binomial distribution|||The 2-sided 95% confidence interval (CI) for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||92.411|69.493|<0.0001
71842225|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.752|TWO_SIDED|95.0|-1.56|2.16||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.32|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||2.16|-1.56|0.752
71842226|NCT02938923|143195818|SUPERIORITY||Mean Difference (Final Values)|-1.16||||0.223|TWO_SIDED|95.0|-3.03|0.71||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.22|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure in the model with covariates.||0.71|-3.03|0.223
71805634|NCT05437510|143111597|SUPERIORITY||Efficacy|77.71||||0.0014|TWO_SIDED|95.0|39.249|93.432|||Exact method using binomial distribution|||The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.||93.432|39.249|0.0014
71805635|NCT05437510|143111598|SUPERIORITY||Efficacy|90.7|||<|0.0001|TWO_SIDED|95.0|63.676|98.813||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for France: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||98.813|63.676|<0.0001
71805636|NCT05437510|143111598|SUPERIORITY||Efficacy|83.2||||0.0036|TWO_SIDED|95.0|33.589|97.593||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for UK: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||97.593|33.589|0.0036
71842227|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|0.85||||0.006|TWO_SIDED|95.0|0.24|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.78|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||1.46|0.24|0.006
71842228|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.863|TWO_SIDED|95.0|-0.81|0.97||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.17|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.97|-0.81|0.863
71894400|NCT01193335|143310960|SUPERIORITY_OR_OTHER||GMC ratio|0.85|||||TWO_SIDED|95.0|0.68|1.07||||||Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.68|
71894401|NCT01193335|143310969|SUPERIORITY_OR_OTHER|||||||0.668|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.668
71894402|NCT01193335|143310969|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.051
71894403|NCT01193335|143310970|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.704
71805637|NCT05437510|143111598|SUPERIORITY||Efficacy|74.62||||0.0051|TWO_SIDED|95.0|29.74|92.595||Adjusted p-value is reported.|Exact method using binomial distribution|||Statistical analysis for Germany: The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.||92.595|29.740|0.0051
71805638|NCT05437510|143111599|SUPERIORITY||Efficacy|57.97|||<|0.0001|TWO_SIDED|95.0|40.36|70.76|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||70.760|40.360|<0.0001
71805639|NCT05437510|143111599|SUPERIORITY||Efficacy|52.48||||0.0039|TWO_SIDED|95.0|20.121|72.36|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||72.360|20.121|0.0039
71805640|NCT05437510|143111599|SUPERIORITY||Efficacy|58.62||||0.0024|TWO_SIDED|95.0|25.115|78.049|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||78.049|25.115|0.0024
71842229|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.091|TWO_SIDED|95.0|-1.67|0.12||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.71|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.12|-1.67|0.091
71894404|NCT01193335|143310970|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
71894405|NCT01193335|143310971|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.531
71842230|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.21|1.44||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.65|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.44|0.21|0.009
71842231|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.778|TWO_SIDED|95.0|-0.76|1.02||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 0.28|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.02|-0.76|0.778
71842232|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.124|TWO_SIDED|95.0|-1.59|0.19||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.19|-1.59|0.124
71894406|NCT01193335|143310971|SUPERIORITY_OR_OTHER||||||>|0.99|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||>0.99
71894407|NCT01193335|143310972|SUPERIORITY_OR_OTHER|||||||0.183|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.183
71894408|NCT01193335|143310972|SUPERIORITY_OR_OTHER|||||||0.357|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.357
71894409|NCT01193335|143310973|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.794
71675652|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|1.2||||0.0865|TWO_SIDED|90.0|1.01|1.43|||t-test, 2 sided|||||1.43|1.01|0.0865
71894410|NCT01193335|143310973|SUPERIORITY_OR_OTHER|||||||0.782|TWO_SIDED||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.||||0.782
71805641|NCT05437510|143111599|SUPERIORITY||Efficacy|70.74||||0.0037|TWO_SIDED|95.0|29.567|89.396|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.396|29.567|0.0037
71842233|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.027|TWO_SIDED|95.0|0.08|1.31||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 2.24|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||1.31|0.08|0.027
71842234|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.833|TWO_SIDED|95.0|-0.97|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.78|-0.97|0.833
71842235|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.1||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.77|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.10|-1.67|0.080
71842236|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.014|TWO_SIDED|95.0|0.14|1.21||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = 2.49|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||1.21|0.14|0.014
71842237|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.834|TWO_SIDED|95.0|-0.84|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -0.21|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.68|-0.84|0.834
71842238|NCT02938923|143195819|SUPERIORITY||Mean Difference (Final Values)|-0.75||||0.054|TWO_SIDED|95.0|-1.52|0.01||Unadjusted p-value|Mixed Models Analysis|t (df, 214) = -1.94|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.01|-1.52|0.054
71842239|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.326|TWO_SIDED|95.0|-0.25|0.74||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.99|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.74|-0.25|0.326
71894411|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR Ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.14|0.63|
71805642|NCT05437510|143111600|SUPERIORITY||Efficacy|82.44|||<|0.0001|TWO_SIDED|95.0|67.271|91.357|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.357|67.271|<0.0001
71805643|NCT05437510|143111600|SUPERIORITY||Efficacy|86.11|||<|0.0001|TWO_SIDED|95.0|60.283|96.459|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.459|60.283|<0.0001
71805644|NCT05437510|143111600|SUPERIORITY||Efficacy|85.2||||0.0004|TWO_SIDED|95.0|50.084|97.183|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.183|50.084|0.0004
71805645|NCT05437510|143111600|SUPERIORITY||Efficacy|74.36||||0.0055|TWO_SIDED|95.0|29.006|92.518|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.518|29.006|0.0055
71842240|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.587|TWO_SIDED|95.0|-0.87|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.54|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.49|-0.87|0.587
71894412|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.24|||||TWO_SIDED|95.0|0.95|1.62||||||Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.62|0.95|
71842241|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.213|TWO_SIDED|95.0|-1.12|0.25||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.25|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.25|-1.12|0.213
71842242|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.41|TWO_SIDED|95.0|-0.32|0.78||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.83|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.78|-0.32|0.410
71675653|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|0.56||||0.0006|TWO_SIDED|90.0|0.43|0.74|||t-test, 2 sided|||||0.74|0.43|0.0006
71675654|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|0.43|||<|0.0001|TWO_SIDED|90.0|0.33|0.57|||t-test, 2 sided|||||0.57|0.33|<0.0001
71675655|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.56|||<|0.0001|TWO_SIDED|90.0|0.47|0.68|||t-test, 2 sided|||||0.68|0.47|<0.0001
71675656|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.49|||<|0.0001|TWO_SIDED|90.0|0.41|0.59|||t-test, 2 sided|||||0.59|0.41|<0.0001
71805646|NCT05437510|143111601|SUPERIORITY||Efficacy|75.31||||0.0013|TWO_SIDED|95.0|38.012|91.747|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.747|38.012|0.0013
71805647|NCT05437510|143111601|SUPERIORITY||Efficacy|78.1||||0.062|TWO_SIDED|95.0|-5.823|97.697|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.697|-5.823|0.0620
71805648|NCT05437510|143111601|SUPERIORITY||Efficacy|91.01||||0.006|TWO_SIDED|95.0|38.156|99.791|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||99.791|38.156|0.0060
71805649|NCT05437510|143111601|SUPERIORITY||Efficacy|26.01||||0.9851|TWO_SIDED|95.0|-337.329|89.162|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||89.162|-337.329|0.9851
71805650|NCT05437510|143111602|SUPERIORITY||Efficacy|43.62|||<|0.0001|TWO_SIDED|95.0|24.677|58.057|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||58.057|24.677|<0.0001
71842243|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.527|TWO_SIDED|95.0|-0.99|0.51||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.63|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.51|-0.99|0.527
71842244|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.219|TWO_SIDED|95.0|-1.23|0.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.23|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.28|-1.23|0.219
71675657|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.11||||0.5234|TWO_SIDED|90.0|0.85|1.45|||t-test, 2 sided|||||1.45|0.85|0.5234
71675658|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|0.29|||<|0.0001|TWO_SIDED|90.0|0.22|0.36|||t-test, 2 sided|||||0.36|0.22|<0.0001
71675659|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|0.72||||0.004|TWO_SIDED|90.0|0.6|0.87|||t-test, 2 sided|||||0.87|0.60|0.0040
71675660|NCT02308540|142868720|OTHER|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|0.58||||0.0001|TWO_SIDED|90.0|0.46|0.73|||t-test, 2 sided|||||0.73|0.46|0.0001
71675661|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 1|-1.0|||||TWO_SIDED|90.0|-5.13|2.66||||||||2.66|-5.13|
71805651|NCT05437510|143111602|SUPERIORITY||Efficacy|34.78||||0.0754|TWO_SIDED|95.0|-4.148|59.648|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||59.648|-4.148|0.0754
71805652|NCT05437510|143111602|SUPERIORITY||Efficacy|40.67||||0.0177|TWO_SIDED|95.0|8.211|62.156|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||62.156|8.211|0.0177
71675662|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 5|3.0|||||TWO_SIDED|90.0|-1.1|7.95||||||||7.95|-1.10|
71675663|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6A|-12.0|||||TWO_SIDED|90.0|-20.94|-2.97||||||||-2.97|-20.94|
71675664|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6B|-7.9|||||TWO_SIDED|90.0|-15.0|-1.01||||||||-1.01|-15.0|
71675665|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 7F|-3.0|||||TWO_SIDED|90.0|-7.95|1.1||||||||1.10|-7.95|
71675666|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 9V|-3.0|||||TWO_SIDED|90.0|-9.17|2.9||||||||2.90|-9.17|
71805653|NCT05437510|143111602|SUPERIORITY||Efficacy|66.38||||0.0046|TWO_SIDED|95.0|25.952|86.137|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||86.137|25.952|0.0046
71805654|NCT05437510|143111607|SUPERIORITY||Efficacy|82.72|||<|0.0001|TWO_SIDED|95.0|67.826|91.49|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||91.490|67.826|<0.0001
71805655|NCT05437510|143111607|SUPERIORITY||Efficacy|86.13|||<|0.0001|TWO_SIDED|95.0|60.34|96.464|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||96.464|60.340|<0.0001
71805656|NCT05437510|143111607|SUPERIORITY||Efficacy|85.92||||0.0002|TWO_SIDED|95.0|52.85|97.311|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||97.311|52.850|0.0002
71805657|NCT05437510|143111607|SUPERIORITY||Efficacy|74.39||||0.0054|TWO_SIDED|95.0|29.077|92.525|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||92.525|29.077|0.0054
71805658|NCT05437510|143111608|SUPERIORITY||Efficacy|41.89|||<|0.0001|TWO_SIDED|95.0|23.073|56.333|||Exact method using binomial distribution|||"Statistical analysis for Overall:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||56.333|23.073|<0.0001
71842245|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.25|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.93|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.69|-0.25|0.355
71675667|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 14|1.0|||||TWO_SIDED|90.0|-4.0|6.27||||||||6.27|-4.00|
71675668|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19A|-5.9|||||TWO_SIDED|90.0|-12.38|0.17||||||||0.17|-12.38|
71675669|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19F|0.0|||||TWO_SIDED|90.0|-4.22|4.33||||||||4.33|-4.22|
71805659|NCT05437510|143111608|SUPERIORITY||Efficacy|32.19||||0.1003|TWO_SIDED|95.0|-7.188|57.545|||Exact method using binomial distribution|||"Statistical analysis for France:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||57.545|-7.188|0.1003
71805660|NCT05437510|143111608|SUPERIORITY||Efficacy|39.83||||0.0164|TWO_SIDED|95.0|8.449|60.911|||Exact method using binomial distribution|||"Statistical analysis for UK:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||60.911|8.449|0.0164
71805661|NCT05437510|143111608|SUPERIORITY||Efficacy|64.06||||0.0058|TWO_SIDED|95.0|23.386|84.478|||Exact method using binomial distribution|||"Statistical analysis for Germany:~The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization."||84.478|23.386|0.0058
71805662|NCT01306162|143111690|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|19.9||1|TWO_SIDED|90.0|191.0|240.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation.|150mg DE + 400mg DR same time (TrtB) vs 150mg DE (TrtA)||240|191|1.0000
71805663|NCT01306162|143111690|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|130.0|STANDARD_DEVIATION|25.0||0.6697|TWO_SIDED|90.0|112.0|151.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||151|112|0.6697
71805664|NCT01306162|143111690|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|236.0|STANDARD_DEVIATION|21.8||0.9992||90.0|173.0|321.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||321|173|0.9992
71805665|NCT01306162|143111690|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|162.0|STANDARD_DEVIATION|20.1||0.9171|TWO_SIDED|90.0|119.0|221.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||221|119|0.9171
71813574|NCT04858802|143129483|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.96||0.063|TWO_SIDED|95.0|-0.5|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 21||0.0|-0.5|0.063
71813575|NCT04858802|143129483|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.77||0.015|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 45||-0.1|-0.4|0.015
71813576|NCT04858802|143129483|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.78||0.007|TWO_SIDED|95.0|-0.4|-0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 90||-0.1|-0.4|0.007
71813577|NCT04858802|143129483|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_DEVIATION|0.75||0.034|TWO_SIDED|95.0|-0.4|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polypoid edema grade in the frontal recess/FSO minus balloon sinus dilation alone mean polypoid edema grade in the frontal recess/FSO|Day 180||0.0|-0.4|0.034
71813578|NCT04858802|143129484|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|0.65||0.83|TWO_SIDED|95.0|-0.2|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 21||0.2|-0.2|0.830
71813579|NCT04858802|143129484|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.59||0.829|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 45||0.1|-0.2|0.829
71842246|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.554|TWO_SIDED|95.0|-0.88|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.59|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.47|-0.88|0.554
71842247|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.219|TWO_SIDED|95.0|-1.1|0.26||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -1.24|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.26|-1.10|0.219
71894413|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.19|||||TWO_SIDED|95.0|0.96|1.47||||||Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.47|0.96|
71675670|NCT02308540|142868722|OTHER|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 23F|-6.0|||||TWO_SIDED|90.0|-12.77|0.4||||||||0.40|-12.77|
71805666|NCT01306162|143111691|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|187.0|STANDARD_DEVIATION|24.3||0.9999|TWO_SIDED|90.0|162.0|215.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||215|162|0.9999
71805667|NCT01306162|143111691|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|115.0|STANDARD_DEVIATION|31.2||0.2207|TWO_SIDED|90.0|95.0|138.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||138|95|0.2207
71805668|NCT01306162|143111691|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|225.0|STANDARD_DEVIATION|26.1||0.9946||90.0|156.0|326.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||326|156|0.9946
71805669|NCT01306162|143111691|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|133.0|STANDARD_DEVIATION|23.0||0.6221|TWO_SIDED|90.0|94.0|190.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||190|94|0.6221
71805670|NCT01306162|143111692|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|STANDARD_DEVIATION|20.7||1|TWO_SIDED|90.0|190.0|241.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||241|190|1.0000
71805671|NCT01306162|143111692|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|132.0|STANDARD_DEVIATION|26.3||0.7223|TWO_SIDED|90.0|113.0|155.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||155|113|0.7223
71805672|NCT01306162|143111692|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|258.0|STANDARD_DEVIATION|24.6||0.9993||90.0|182.0|365.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||365|182|0.9993
71894414|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|0.97|||||TWO_SIDED|95.0|0.74|1.26||||||Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.26|0.74|
71675671|NCT02308540|142868724|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 1|9.1|||||TWO_SIDED|90.0|-15.55|36.11||||||||36.11|-15.55|
71805673|NCT01306162|143111692|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|159.0|STANDARD_DEVIATION|21.5||0.8875|TWO_SIDED|90.0|114.0|222.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||222|114|0.8875
71842248|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.345|TWO_SIDED|95.0|-0.24|0.68||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.95|Difference between the BADL changes (EX+T - EX+P)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.68|-0.24|0.345
71894415|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|0.8|||||TWO_SIDED|95.0|0.63|1.02||||||Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.02|0.63|
71842249|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.494|TWO_SIDED|95.0|-0.88|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.69|Difference between the BADL changes (EX+T - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.43|-0.88|0.494
71675672|NCT02308540|142868724|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 5|0.0|||||TWO_SIDED|90.0|-18.56|18.56||||||||18.56|-18.56|
71675673|NCT02308540|142868724|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 6B|5.0|||||TWO_SIDED|90.0|-12.35|22.97||||||||22.97|-12.35|
71805674|NCT01306162|143111693|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|180.0|STANDARD_DEVIATION|24.6||0.9998|TWO_SIDED|90.0|156.0|207.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)||207|156|0.9998
71805675|NCT01306162|143111693|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|114.0|STANDARD_DEVIATION|29.4||0.1866|TWO_SIDED|90.0|95.0|136.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)||136|95|0.1866
71805676|NCT01306162|143111693|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|234.0|STANDARD_DEVIATION|26.7||0.9958||90.0|160.0|340.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)||340|160|0.9958
71805677|NCT01306162|143111693|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|126.0|STANDARD_DEVIATION|22.6||0.5164|TWO_SIDED|90.0|89.0|179.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)||179|89|0.5164
71805678|NCT03836287|143111750|OTHER||Odds Ratio (OR)|2.34||||0.0004|TWO_SIDED|95.0|1.47|3.72|||Regression, Logistic|||||3.72|1.47|0.0004
71805679|NCT03836287|143111751|OTHER||Mean Difference (Net)|-29.71|STANDARD_ERROR_OF_MEAN|9.543||0.0019|TWO_SIDED|95.0|-48.42|-11.0|||ANCOVA|||||-11.00|-48.42|0.0019
71805680|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.231|||TWO_SIDED|95.0|-0.03|0.92|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 4||0.92|-0.03|
71805681|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|95.0|0.25|1.13|||Mixed Model Repeated Measure Analysis||Mean difference = GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.13|0.25|
71805682|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|95.0|-0.2|0.8|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.80|-0.20|
71805683|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.292|||TWO_SIDED|95.0|-0.24|0.95|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||0.95|-0.24|
71675674|NCT02308540|142868724|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 14|5.3|||||TWO_SIDED|90.0|-12.15|24.01||||||||24.01|-12.15|
71675675|NCT02308540|142868724|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19A|-5.9|||||TWO_SIDED|90.0|-26.41|11.01||||||||11.01|-26.41|
71675676|NCT02308540|142868724|OTHER|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19F|5.0|||||TWO_SIDED|90.0|-11.64|22.97||||||||22.97|-11.64|
71805684|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|0.279|||TWO_SIDED|95.0|-0.05|1.09|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg- Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||1.09|-0.05|
71805685|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.319|||TWO_SIDED|95.0|-0.61|0.69|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||0.69|-0.61|
71805686|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|95.0|0.15|1.11|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.11|0.15|
71805687|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|95.0|-0.06|0.86|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||0.86|-0.06|
71805688|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.259|||TWO_SIDED|95.0|-0.29|0.77|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||0.77|-0.29|
71805689|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|0.251|||TWO_SIDED|95.0|0.1|1.12|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 7||1.12|0.10|
71805690|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|95.0|0.09|1.08|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||1.08|0.09|
71805691|NCT00833989|143111772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.277|||TWO_SIDED|95.0|-0.39|0.73|||Mixed Model Repeated Measure Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||0.73|-0.39|
71805692|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.981|||TWO_SIDED|95.0|-0.6|19.71|||Mixed Model Repeated Measures Analysis||Mean difference =GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 4||19.71|-0.60|
71805693|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.47|STANDARD_ERROR_OF_MEAN|4.801|||TWO_SIDED|95.0|-1.32|18.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4||18.26|-1.32|
71805694|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|5.47|||TWO_SIDED|95.0|-11.1|11.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.24|-11.1|
71805695|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.58|STANDARD_ERROR_OF_MEAN|5.631|||TWO_SIDED|95.0|0.01|23.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5||23.15|0.01|
71805696|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.77|STANDARD_ERROR_OF_MEAN|5.411|||TWO_SIDED|95.0|-2.35|19.89|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5||19.89|-2.35|
71805697|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|6.195|||TWO_SIDED|95.0|-12.2|13.21|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5||13.21|-12.2|
71805698|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.66|STANDARD_ERROR_OF_MEAN|5.351|||TWO_SIDED|95.0|-1.34|20.66|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6||20.66|-1.34|
71805699|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.45|STANDARD_ERROR_OF_MEAN|5.198|||TWO_SIDED|95.0|-3.22|18.13|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6||18.13|-3.22|
71805700|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.63|STANDARD_ERROR_OF_MEAN|5.959|||TWO_SIDED|95.0|-22.9|1.6|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.60|-22.9|
71805701|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|6.134|||TWO_SIDED|95.0|-3.07|22.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 7||22.24|-3.07|
71805702|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.89|STANDARD_ERROR_OF_MEAN|5.948|||TWO_SIDED|95.0|-6.37|18.15|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7||18.15|-6.37|
71805703|NCT00833989|143111773|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|6.768|||TWO_SIDED|95.0|-17.1|10.84|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 7||10.84|-17.1|
71842250|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.45||||0.18|TWO_SIDED|95.0|-1.11|0.21||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.35|Difference between the BADL changes (EX+P - EUC)|Comparison of the Basic Activities of Daily Living (BADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||0.21|-1.11|0.180
71805704|NCT00833989|143111774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|7.047|||TWO_SIDED|95.0|-15.81|12.86|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||12.86|-15.81|
71805705|NCT00833989|143111774|SUPERIORITY_OR_OTHER||Median Difference (Net)|9.86|STANDARD_ERROR_OF_MEAN|6.852|||TWO_SIDED|95.0|-4.08|23.8|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||23.80|-4.08|
71805706|NCT00833989|143111774|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|7.376|||TWO_SIDED|95.0|-20.41|9.6|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||9.60|-20.41|
71805707|NCT00833989|143111774|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|10.04|||TWO_SIDED|95.0|-22.87|18.07|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||18.07|-22.87|
71805708|NCT00833989|143111774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.03|STANDARD_ERROR_OF_MEAN|10.31|||TWO_SIDED|95.0|-15.95|26.0|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||26.00|-15.95|
71805709|NCT00833989|143111774|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|10.916|||TWO_SIDED|95.0|-32.29|12.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment \* Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.15|-32.29|
71842251|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.4|Difference between the changes of IADL of EX+T - EX+P|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.50|-0.75|0.693
71842252|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.327|TWO_SIDED|95.0|-1.27|0.43||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.98|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.43|-1.27|0.327
71675677|NCT04481789|142868784|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin Alone).|LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.08|0.97|
71805710|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|5.147|||TWO_SIDED|95.0|-10.4|10.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||10.61|-10.4|
71805711|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.75|STANDARD_ERROR_OF_MEAN|5.157|||TWO_SIDED|95.0|-7.75|13.26|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||13.26|-7.75|
71805712|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.85|STANDARD_ERROR_OF_MEAN|5.409|||TWO_SIDED|95.0|-6.17|15.88|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||15.88|-6.17|
71805713|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|6.504|||TWO_SIDED|95.0|-12.1|14.45|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 5||14.45|-12.1|
71805714|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|6.426|||TWO_SIDED|95.0|-11.0|15.12|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 5||15.12|-11.0|
71805715|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22|STANDARD_ERROR_OF_MEAN|6.82|||TWO_SIDED|95.0|-16.1|11.68|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 5||11.68|-16.1|
71805716|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|6.664|||TWO_SIDED|95.0|-12.9|14.18|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||14.18|-12.9|
71805717|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|6.595||||95.0|-12.4|14.43|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||14.43|-12.4|
71805718|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-15.2|13.32|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||13.32|-15.2|
71805719|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|6.953|||TWO_SIDED|95.0|-11.9|16.4|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 7||16.40|-11.9|
71842253|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.493|TWO_SIDED|95.0|-1.15|0.56||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = -0.69|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an unstructured covariance structure.||0.56|-1.15|0.493
71842254|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.698|TWO_SIDED|95.0|-0.72|0.49||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.39|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.49|-0.72|0.698
71805720|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.52|STANDARD_ERROR_OF_MEAN|6.909|||TWO_SIDED|95.0|-10.5|17.55|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 7||17.55|-10.5|
71805721|NCT00833989|143111775|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|7.328|||TWO_SIDED|95.0|-15.4|14.39|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 7||14.39|-15.4|
71805722|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-5.33|8.65|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4||8.65|-5.33|
71805723|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-7.56|6.96|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4||6.96|-7.56|
71805724|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.534|||TWO_SIDED|95.0|-2.67|11.78|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4||11.78|-2.67|
71805725|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|3.841|||TWO_SIDED|95.0|-5.78|9.89|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 5||9.89|-5.78|
71805726|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.35|STANDARD_ERROR_OF_MEAN|3.958|||TWO_SIDED|95.0|-10.4|5.72|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 5||5.72|-10.4|
71805727|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.44|STANDARD_ERROR_OF_MEAN|3.978|||TWO_SIDED|95.0|-6.68|9.55|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 5||9.55|-6.68|
71805728|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.46|STANDARD_ERROR_OF_MEAN|4.109|||TWO_SIDED|95.0|-4.94|11.85|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 6||11.85|-4.94|
71805729|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|4.235|||TWO_SIDED|95.0|-8.15|9.12|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 6||9.12|-8.15|
71805730|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.77|STANDARD_ERROR_OF_MEAN|4.28|||TWO_SIDED|95.0|-7.97|9.5|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 6||9.50|-7.97|
71805731|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|4.205|||TWO_SIDED|95.0|-5.53|11.61|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7||11.61|-5.53|
71805732|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|STANDARD_ERROR_OF_MEAN|4.376|||TWO_SIDED|95.0|-11.5|6.32|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7||6.32|-11.5|
71805733|NCT00833989|143111776|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73|STANDARD_ERROR_OF_MEAN|4.396|||TWO_SIDED|95.0|-5.22|12.69|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment \* Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7||12.69|-5.22|
71805734|NCT00833989|143111777|SUPERIORITY_OR_OTHER|||||||0.926|||||||Fisher Exact|||Visit 4||||0.9260
71805735|NCT00833989|143111777|SUPERIORITY_OR_OTHER|||||||0.5647|||||||Fisher Exact|||Visit 6||||0.5647
71805736|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.34|STANDARD_ERROR_OF_MEAN|0.896|||TWO_SIDED|95.0|-3.17|0.49|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 3||0.49|-3.17|
71805737|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.861|||TWO_SIDED|95.0|-1.95|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 3||1.57|-1.95|
71805738|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|0.933|||TWO_SIDED|95.0|-4.83|-1.02|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 3||-1.02|-4.83|
71842255|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.404|TWO_SIDED|95.0|-1.17|0.47||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.84|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.47|-1.17|0.404
71842256|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.585|TWO_SIDED|95.0|-1.06|0.6||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.55|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.60|-1.06|0.585
71842257|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.399|TWO_SIDED|95.0|-0.31|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.85|Difference between IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.31|0.399
71805739|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.868|||TWO_SIDED|95.0|-2.47|1.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 4||1.08|-2.47|
71805740|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.834|||TWO_SIDED|95.0|-1.98|1.44|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4||1.44|-1.98|
71805741|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.904|||TWO_SIDED|95.0|-2.77|0.92|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4||0.92|-2.77|
71675678|NCT04481789|142868784|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.99||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||0.99|0.88|
71675679|NCT04481789|142868784|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.98|1.09||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.09|0.98|
71805742|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-3.64|1.57|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6||1.57|-3.64|
71805743|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|1.278|||TWO_SIDED|95.0|-2.97|2.24|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6||2.24|-2.97|
71805744|NCT00833989|143111778|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|2.21|||TWO_SIDED|95.0|-0.66|1.408|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Change from Baseline = Treatment + Visit + Treatment \* Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6||1.408|-0.66|
71805745|NCT00833989|143111779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.46|STANDARD_ERROR_OF_MEAN|12.584|||TWO_SIDED|95.0|-6.11|45.04|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 4||45.04|-6.11|
71805746|NCT00833989|143111779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.99|STANDARD_ERROR_OF_MEAN|12.131|||TWO_SIDED|95.0|-3.66|45.64|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 4||45.64|-3.66|
71842258|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.554|TWO_SIDED|95.0|-0.53|0.98||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0.59|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.98|-0.53|0.554
71842259|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.76|0.76||Unadjusted p-value|Mixed Models Analysis|t (df, 112) = 0|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an unstructured covariance structure.||0.76|-0.76|0.998
71842260|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.378|TWO_SIDED|95.0|-0.28|0.73||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.88|Difference between the IADL changes (EX+T - EX+P)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.73|-0.28|0.378
71842261|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.608|TWO_SIDED|95.0|-0.53|0.91||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.51|Difference between the IADL changes (EX+T - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.91|-0.53|0.608
71805747|NCT00833989|143111779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.79|STANDARD_ERROR_OF_MEAN|13.143|||TWO_SIDED|95.0|-14.9|38.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 4||38.50|-14.9|
71805748|NCT00833989|143111779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.71|STANDARD_ERROR_OF_MEAN|9.021|||TWO_SIDED|95.0|-2.63|34.06|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 1 mg/kg, Visit 6||34.06|-2.63|
71805749|NCT00833989|143111779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.56|STANDARD_ERROR_OF_MEAN|8.835|||TWO_SIDED|95.0|-6.38|29.5|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 5 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 5 mg/kg, Visit 6||29.50|-6.38|
71805750|NCT00833989|143111779|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.49|STANDARD_ERROR_OF_MEAN|9.641|||TWO_SIDED|95.0|-27.1|12.08|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 15 mg/kg - Placebo Barthel Total Score= Treatment + Visit + Treatment \*Visit|Placebo Vs GSK249320 15 mg/kg, Visit 6||12.08|-27.1|
71805751|NCT00833989|143111780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|1.849|||TWO_SIDED|95.0|-4.12|3.43|||ANCOVA||Mean difference= GSK249320 1 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 1 mg/kg, Visit 6||3.43|-4.12|
71805752|NCT00833989|143111780|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.856|||TWO_SIDED|95.0|-3.96|3.62|||ANCOVA||Mean difference= GSK249320 5 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 5 mg/kg, Visit 6||3.62|-3.96|
71805753|NCT00833989|143111780|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|STANDARD_ERROR_OF_MEAN|2.037|||TWO_SIDED|95.0|-5.31|3.01|||ANCOVA||Mean difference= GSK249320 15 mg/kg - Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 15 mg/kg, Visit 6||3.01|-5.31|
71675680|NCT04481789|142868785|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Rosuvastatin + Edaravone / Rosuvastatin).|LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.06||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.06|0.91|
71842262|NCT02938923|143195820|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.915|TWO_SIDED|95.0|-0.76|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.11|Difference between the IADL changes (EX+P - EUC)|Comparison of the Instrumental Activities of Daily Living (IADL) subscale based on contrasts between two groups at baseline to three months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.||0.69|-0.76|0.915
71842263|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.602|TWO_SIDED|95.0|-1.36|2.33||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.52|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||2.33|-1.36|0.602
71842264|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.454|TWO_SIDED|95.0|-3.48|1.56||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.75|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.56|-3.48|0.454
71842265|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-1.45||||0.262|TWO_SIDED|95.0|-3.98|1.09||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.13|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure.||1.09|-3.98|0.262
71842266|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.639|TWO_SIDED|95.0|-1.47|2.4||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.47|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.40|-1.47|0.639
71842267|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.438|TWO_SIDED|95.0|-3.66|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.78|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-3.66|0.438
71842268|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.265|TWO_SIDED|95.0|-4.14|1.14||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -1.12|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.14|-4.14|0.265
71842269|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.555|TWO_SIDED|95.0|-1.11|2.07||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.59|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.07|-1.11|0.555
71842270|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.917|TWO_SIDED|95.0|-2.39|2.15||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.10|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||2.15|-2.39|0.917
71805754|NCT00833989|143111781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|1.408|||TWO_SIDED|95.0|-3.12|2.63|||ANCOVA||"Mean difference= GSK249320 1 mg/kg - Placebo.~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 1 mg/kg, Visit 6||2.63|-3.12|
71805755|NCT00833989|143111781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.55|STANDARD_ERROR_OF_MEAN|1.347|||TWO_SIDED|95.0|-1.2|4.3|||ANCOVA||"Mean difference= GSK249320 5 mg/kg - Placebo~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 5 mg/kg, Visit 6||4.30|-1.20|
71805756|NCT00833989|143111781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|1.486|||TWO_SIDED|95.0|-3.09|2.98|||ANCOVA||"Mean difference= GSK249320 15 mg/kg - Placebo.~Day 90 GDS Score= Treatment+Day 5 GDS Score"|Placebo Vs GSK249320 15 mg/kg, Visit 6||2.98|-3.09|
71805757|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.289|STANDARD_ERROR_OF_MEAN|0.2639|||TWO_SIDED|95.0|-0.841|0.264|||Mixed Model Repeated Measures Analysis||Mean difference= GSK249320 1 mg/kg - Placebo Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline|Stimulation Level 100%, Visit 4 Day 30||0.264|-0.841|
71805758|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.2637|||TWO_SIDED|95.0|-0.862|0.241|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.241|-0.862|
71805759|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.303|STANDARD_ERROR_OF_MEAN|0.3172|||TWO_SIDED|95.0|-0.966|0.361|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30||0.361|-0.966|
71805760|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.204|STANDARD_ERROR_OF_MEAN|0.1841|||TWO_SIDED|95.0|-0.184|0.593|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.593|-0.184|
71805761|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.105|STANDARD_ERROR_OF_MEAN|0.1846|||TWO_SIDED|95.0|-0.284|0.494|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.494|-0.284|
71675681|NCT04481789|142868785|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Sildenafil + Edaravone / Sildenafil Alone).|LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.8|1.1||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.10|0.80|
71805762|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.416|STANDARD_ERROR_OF_MEAN|0.2602|||TWO_SIDED|95.0|-0.132|0.965|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112||0.965|-0.132|
71805763|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.156|STANDARD_ERROR_OF_MEAN|0.8652|||TWO_SIDED|95.0|-0.65|2.961|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||2.961|-0.650|
71805764|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.518|STANDARD_ERROR_OF_MEAN|0.8324|||TWO_SIDED|95.0|-2.249|1.213|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.213|-2.249|
71805765|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.269|STANDARD_ERROR_OF_MEAN|1.0383|||TWO_SIDED|95.0|-2.436|1.898|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30||1.898|-2.436|
71805766|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.806|STANDARD_ERROR_OF_MEAN|0.5862|||TWO_SIDED|95.0|-0.42|2.031|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||2.031|-0.420|
71842271|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.606|TWO_SIDED|95.0|-2.87|1.68||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.52|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure.||1.68|-2.87|0.606
71842272|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.549|TWO_SIDED|95.0|-1.09|2.04||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = 0.60|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.04|-1.09|0.549
71842273|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.887|TWO_SIDED|95.0|-2.38|2.06||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.14|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||2.06|-2.38|0.887
71842274|NCT02938923|143195821|SUPERIORITY||Mean Difference (Final Values)|-0.64||||0.574|TWO_SIDED|95.0|-2.87|1.59||Unadjusted p-value|Mixed Models Analysis|t (df, 234) = -0.56|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Toeplitz covariance structure in the model with covariates.||1.59|-2.87|0.574
71842275|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.649|TWO_SIDED|95.0|-3.19|5.11||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.46|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||5.11|-3.19|0.649
71805767|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.007|STANDARD_ERROR_OF_MEAN|0.564|||TWO_SIDED|95.0|-1.183|1.168|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit"|Stimulation Level 110%, Visit 7 Day 112||1.168|-1.183|
71805768|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.506|STANDARD_ERROR_OF_MEAN|0.757|||TWO_SIDED|95.0|-0.064|3.077|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112||3.077|-0.064|
71805769|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.644|STANDARD_ERROR_OF_MEAN|1.2976|||TWO_SIDED|95.0|-1.056|4.344|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||4.344|-1.056|
71805770|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.231|STANDARD_ERROR_OF_MEAN|1.1762|||TWO_SIDED|95.0|-2.681|2.219|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.219|-2.681|
71805771|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.184|STANDARD_ERROR_OF_MEAN|1.4796|||TWO_SIDED|95.0|-3.279|2.91|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30||2.910|-3.279|
71805772|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.622|STANDARD_ERROR_OF_MEAN|0.9746|||TWO_SIDED|95.0|-1.428|2.672|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||2.672|-1.428|
71675682|NCT04481789|142868785|OTHER|Estimates of least squares mean difference of log-transformed PK parameters between treatments were obtained with their 2-sided 90%CIs for the difference. These estimates and limits were then back-transformed to obtain ratios of least squares geometric means. If the 90%CIs lay entirely within the limits of 0.80 to 1.25, this would provide evidence of no effect of edaravone on the PK of rosuvastatin, sildenafil, and furosemide (LS Mean Ratio: Furosemide + Edaravone / Furosemide Alone).|LS Mean Ratio|1.08|||||TWO_SIDED|90.0|0.96|1.23||||||PK parameters of rosuvastatin, sildenafil, and furosemide alone and in the presence of edaravone were analyzed for the assessments of effect on PK of rosuvastatin, sildenafil, and furosemide by edaravone.||1.23|0.96|
71675683|NCT04481789|142868800|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.842|||||TWO_SIDED|90.0|0.697|1.017||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.017|0.697|
71675684|NCT04481789|142868800|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.737|||||TWO_SIDED|90.0|0.61|0.891||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.891|0.610|
71805773|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.602|STANDARD_ERROR_OF_MEAN|0.934|||TWO_SIDED|95.0|-2.56|1.356|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||1.356|-2.560|
71805774|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.063|STANDARD_ERROR_OF_MEAN|1.281|||TWO_SIDED|95.0|-0.61|4.736|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112||4.736|-0.610|
71805775|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.556|STANDARD_ERROR_OF_MEAN|1.4588|||TWO_SIDED|95.0|-1.494|4.607|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||4.607|-1.494|
71805776|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.531|STANDARD_ERROR_OF_MEAN|1.2336|||TWO_SIDED|95.0|-3.102|2.041|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||2.041|-3.102|
71805777|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.185|STANDARD_ERROR_OF_MEAN|1.5697|||TWO_SIDED|95.0|-3.471|3.101|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30||3.101|-3.471|
71805778|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.686|STANDARD_ERROR_OF_MEAN|1.2689|||TWO_SIDED|95.0|-1.996|3.367|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||3.367|-1.996|
71805779|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.556|STANDARD_ERROR_OF_MEAN|1.0822|||TWO_SIDED|95.0|-2.838|1.726|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||1.726|-2.838|
71805780|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.219|STANDARD_ERROR_OF_MEAN|1.4792|||TWO_SIDED|95.0|-0.884|5.322|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112||5.322|-0.884|
71805781|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.631|STANDARD_ERROR_OF_MEAN|1.589|||TWO_SIDED|95.0|-1.696|4.958|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||4.958|-1.696|
71805782|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.508|STANDARD_ERROR_OF_MEAN|1.2985|||TWO_SIDED|95.0|-3.219|2.203|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||2.203|-3.219|
71842276|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.389|TWO_SIDED|95.0|-3.22|8.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.23|-3.22|0.389
71842277|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|1.55||||0.598|TWO_SIDED|95.0|-4.22|7.31||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.31|-4.22|0.598
71675685|NCT04481789|142868801|OTHER|Estimated difference in least squares means and corresponding 90% CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 1 Hour After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.657|||||TWO_SIDED|90.0|0.379|1.137||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||1.137|0.379|
71805783|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|1.6603|||TWO_SIDED|95.0|-3.369|3.588|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30||3.588|-3.369|
71805784|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.852|STANDARD_ERROR_OF_MEAN|1.5675|||TWO_SIDED|95.0|-2.446|4.15|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 1 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||4.150|-2.446|
71675686|NCT04481789|142868801|OTHER|Estimated difference in least squares means and corresponding 90%CI of log-transformed PK parameters were back transformed to obtain the estimate and CI of the geometric mean ratio of 4 Hours After a High-fat Meal condition to the fasted state.|LS Mean Ratio|0.522|||||TWO_SIDED|90.0|0.301|0.903||||||PK parameters of unchanged edaravone were analyzed for the assessments of food effect on PK.||0.903|0.301|
71675687|NCT02751450|142868814|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.882|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.882|-1.150|<0.0001
71675688|NCT01290679|142868826|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|32.2|||<|0.001|TWO_SIDED|95.0|23.3|41.2|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.||41.2|23.3|<0.001
71805785|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.357|STANDARD_ERROR_OF_MEAN|1.2918|||TWO_SIDED|95.0|-3.074|2.359|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 5 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||2.359|-3.074|
71805786|NCT00833989|143111782|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.686|STANDARD_ERROR_OF_MEAN|1.7306|||TWO_SIDED|95.0|-1.937|5.308|||Mixed Model Repeated Measures Analysis||"Mean difference= GSK249320 15 mg/kg - Placebo~Change from Baseline= Treatment + Visit + Treatment\* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112||5.308|-1.937|
71805787|NCT01949480|143111785|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.643|||||||t-test, 2 sided|||||||0.643
71805788|NCT01949480|143111787|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.077|||||||t-test, 2 sided|||This p-value is calculated for the NRS at rest.||||.077
71805789|NCT01949480|143111787|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.39|||||||t-test, 2 sided|||This p-value is calculated for the NRS during deep inspiration at 24 hrs.||||0.39
71805790|NCT01949480|143111788|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.605|||||||t-test, 2 sided|||||||0.605
71805791|NCT01949480|143111789|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.104|||||||t-test, 2 sided|||This p-value is for the Local Anesthetic infused in 24 hrs.||||0.104
71805792|NCT01949480|143111790|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.308|||||||t-test, 2 sided|||||||0.308
71805793|NCT01949480|143111791|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.487|||||||t-test, 2 sided|||||||0.487
71675689|NCT01290679|142868827|SUPERIORITY_OR_OTHER||Difference in proportions of SVRW72|29.3|||<|0.001|TWO_SIDED|95.0|20.2|38.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.||38.5|20.2|<0.001
71805794|NCT01949480|143111792|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.493|||||||t-test, 2 sided|||||||0.493
71805795|NCT01949480|143111793|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.574|||||||t-test, 2 sided|||||||0.574
71805796|NCT01949480|143111794|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.913|||||||t-test, 2 sided|||||||0.913
71805797|NCT01949480|143111795|NON_INFERIORITY|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.783|||||||t-test, 2 sided|||||||0.783
71805798|NCT03825380|143111850|NON_INFERIORITY|"Primary tested:Non-inferiority of T4032 to Lumigan® on the change from baseline in IOP using a MMRM. 3 independent models will be performed, one for each time point (8:00, 10:00~\& 16:00). The 95% CI for treatment effect (difference T4032 - Lumigan) will be estimated at Wk 12. NI will be achieved if the upper bound of the 95% CI for the difference between treatment groups (T4032 - Lumigan) is lower than the margin of +1.5 mmHg for each of the 3 time points 8:00, 10:00 \& 16:00."|Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.453|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||||0.28|-0.62|0.453
71805799|NCT02105948|143111888|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.036|TWO_SIDED|95.0|0.68|0.98||Adjusted p-value to account for two treatment comparisons|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted for FEV1,smoking status and offset of log (time in on-and off-treatment period)|||0.98|0.68|=0.036
71675690|NCT01290679|142868828|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|31.5|||<|0.001|TWO_SIDED|95.0|22.5|40.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.||40.5|22.5|<0.001
71675691|NCT01290679|142868829|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|32.3|||<|0.001|TWO_SIDED|95.0|23.5|41.0|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.||41.0|23.5|<0.001
71675692|NCT01290679|142868856|SUPERIORITY_OR_OTHER||Mean differences|-16.776|STANDARD_ERROR_OF_MEAN|6.3081||0.008|TWO_SIDED|95.0|-29.1502|-4.4025|||Piecewise Linear Model|||Fatigue Severity Score AUC60||-4.4025|-29.1502|0.008
71675693|NCT01290679|142868856|SUPERIORITY_OR_OTHER||Mean differences|-18.837|STANDARD_ERROR_OF_MEAN|7.4715||0.012|TWO_SIDED|95.0|-33.4933|-4.1801|||Piecewise Linear Model|||Fatigue Severity Score AUC72||-4.1801|-33.4933|0.012
71675694|NCT01290679|142868857|SUPERIORITY_OR_OTHER||Mean differences|-282.16|STANDARD_ERROR_OF_MEAN|105.4927||0.008|TWO_SIDED|95.0|-489.1252|-75.1949|||Piecewise Linear Model|||Impairment in Work Productivity AUC60||-75.1949|-489.1252|0.008
71675695|NCT01290679|142868857|SUPERIORITY_OR_OTHER||Mean differences|-324.363|STANDARD_ERROR_OF_MEAN|124.026||0.009|TWO_SIDED|95.0|-567.708|-81.0182|||Piecewise Linear Model|||Impairment in Work Productivity AUC72||-81.0182|-567.7080|0.009
71675696|NCT01290679|142868858|SUPERIORITY_OR_OTHER||Mean Differences|-282.436|STANDARD_ERROR_OF_MEAN|104.9894||0.007|TWO_SIDED|95.0|-488.415|-76.4566|||Piecewise linear model|||Impairment in Daily Activities AUC60||-76.4566|-488.4150|0.007
71675697|NCT01290679|142868858|SUPERIORITY_OR_OTHER||Mean differences|-329.204|STANDARD_ERROR_OF_MEAN|123.408||0.008|TWO_SIDED|95.0|-571.3389|-87.0695|||Piecewise Linear Model|||Impairment in Daily Activities AUC72||-87.0695|-571.3389|0.008
71675698|NCT01290679|142868859|SUPERIORITY_OR_OTHER||Mean differences|-186.852|STANDARD_ERROR_OF_MEAN|121.4741||0.125|TWO_SIDED|95.0|-425.4109|51.7059|||Piecewise linear model|||Time Missed from Work AUC60||51.7059|-425.4109|0.125
71805800|NCT02105948|143111888|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.82|||=|0.029|TWO_SIDED|95.0|0.68|0.98||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||0.98|0.68|=0.029
71675699|NCT01290679|142868859|SUPERIORITY_OR_OTHER||Mean differences|-188.202|STANDARD_ERROR_OF_MEAN|141.1702||0.183|TWO_SIDED|95.0|-465.507|89.104|||Piecewise linear model|||Time Missed from Work AUC72||89.1040|-465.5070|0.183
71805801|NCT02105948|143111889|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||>|0.999|TWO_SIDED|95.0|0.85|1.12||Adjusted p-value to account for two treatment comparisons|Negative Binomial Model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|>0.999
71805802|NCT02105948|143111889|SUPERIORITY||Rate ratio (mepolizumab/placebo)|0.98|||=|0.731|TWO_SIDED|95.0|0.85|1.12||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)|||1.12|0.85|=0.731
71842278|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.676|TWO_SIDED|95.0|-3.26|5.02||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.42|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||5.02|-3.26|0.676
71842279|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|2.48||||0.394|TWO_SIDED|95.0|-3.24|8.19||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.85|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||8.19|-3.24|0.394
71675700|NCT00403481|142868876|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
71675701|NCT00403481|142868877|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 for both daytime and nighttime. No multiplicity adjustments.|one-sample t-test|||||||<0.0001
71675702|NCT00403481|142868878|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
71675703|NCT00403481|142868879|SUPERIORITY_OR_OTHER|||||||0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||0.0001
71675704|NCT00403481|142868881|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
71675705|NCT00403481|142868882|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both the daytime and nighttime analyses|one-sample t-test|||||||<0.0001
71675706|NCT00403481|142868883|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||one-sample t-test|||||||<0.0001
71675707|NCT00403481|142868884|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||\<0.0001 applies to both 4 hour and 6 hour analyses|one-sample t-test|||||||<0.0001
71675708|NCT03139578|142868905|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|1.18|||||TWO_SIDED|95.0|0.46|3.06|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||3.06|0.46|
71675709|NCT03139578|142868905|NON_INFERIORITY|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|0.93|||||TWO_SIDED|95.0|0.34|2.52|||Generalized linear mixed model|Simulation-based adjustment was utilized to address the multiple comparisons of different base curves.|Cumulative odds ratio was calculated as Test over Control.|||2.52|0.34|
71675710|NCT03139578|142868906|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|93.8|||||TWO_SIDED|97.5|81.1|98.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||98.1|81.1|
71675711|NCT03139578|142868906|EQUIVALENCE|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|83.3|||||TWO_SIDED|97.5|68.3|92.1|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||92.1|68.3|
71675712|NCT03139578|142868906|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100|90.5|
71675713|NCT03139578|142868906|EQUIVALENCE|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||TWO_SIDED|97.5|90.5|100.0|||Wilson Method||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.|||100.0|90.5|
71675714|NCT03139578|142868907|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.7|-0.3|
71675715|NCT03139578|142868907|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
71675716|NCT03139578|142868908|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.4|
71675717|NCT03139578|142868908|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.2|
71675718|NCT03139578|142868909|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.1|
71675719|NCT03139578|142868909|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.3|-0.2|
71842280|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.585|TWO_SIDED|95.0|-4.15|7.35||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.55|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.35|-4.15|0.585
71842281|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||4.65|-3.56|0.794
71842282|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|2.27||||0.449|TWO_SIDED|95.0|-3.62|8.16||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.76|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||8.16|-3.62|0.449
71842283|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.567|TWO_SIDED|95.0|-4.2|7.64||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.57|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure.||7.64|-4.20|0.567
71842284|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.794|TWO_SIDED|95.0|-3.56|4.65||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.26|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||4.65|-3.56|0.794
71675720|NCT03139578|142868910|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.5|-0.5|
71842285|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.526|TWO_SIDED|95.0|-3.97|7.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.64|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.75|-3.97|0.526
71842286|NCT02938923|143195822|SUPERIORITY||Mean Difference (Final Values)|1.34||||0.654|TWO_SIDED|95.0|-4.55|7.23||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.45|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Compound Symmetry covariance structure in the model with covariates.||7.23|-4.55|0.654
71842287|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.597|TWO_SIDED|95.0|-1.72|2.98||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.53|Difference between the changes (EX+T - EX+P) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||2.98|-1.72|0.597
71842288|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.184|TWO_SIDED|95.0|-5.41|1.04||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.33|Difference between the changes (EX+T - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||1.04|-5.41|0.184
71842289|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.82||||0.089|TWO_SIDED|95.0|-6.07|0.44||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.71|Difference between the changes (EX+P - EUC) on Physical Health domain|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||0.44|-6.07|0.089
71675721|NCT03139578|142868910|NON_INFERIORITY|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.4|-0.6|
71675722|NCT03139578|142868911|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.002|||||TWO_SIDED|95.0|-0.009|0.012|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.012|-0.009|
71675723|NCT03139578|142868911|NON_INFERIORITY|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.001|||||TWO_SIDED|95.0|-0.012|0.009|||Linear mixed model|Simulation-based adjustment was used to address the multiple comparisons.||||0.009|-0.012|
71842290|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.635|TWO_SIDED|95.0|-2.01|3.28||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.47|Difference in the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.28|-2.01|0.635
71842291|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.15||||0.242|TWO_SIDED|95.0|-5.76|1.46||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.17|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||1.46|-5.76|0.242
71842292|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.79||||0.132|TWO_SIDED|95.0|-6.42|0.85||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -1.51|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||0.85|-6.42|0.132
71805803|NCT02105948|143111890|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.036|TWO_SIDED|95.0|0.6|0.94||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.036
71805804|NCT02105948|143111890|SUPERIORITY||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0.012|TWO_SIDED|95.0|0.6|0.94||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||0.94|0.60|=0.012
71805805|NCT02105948|143111891|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.598|TWO_SIDED|95.0|0.77|1.75||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.598
71805806|NCT02105948|143111891|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.16|||=|0.479|TWO_SIDED|95.0|0.77|1.75||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.75|0.77|=0.479
71805807|NCT02105948|143111892|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||>|0.999|TWO_SIDED|95.0|-2.8|3.2||Adjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|>0.999
71842293|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.193|TWO_SIDED|95.0|-0.77|3.81||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.31|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.81|-0.77|0.193
71842294|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|1.44||||0.39|TWO_SIDED|95.0|-1.86|4.75||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.86|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||4.75|-1.86|0.390
71842295|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.965|TWO_SIDED|95.0|-3.39|3.25||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.04|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure.||3.25|-3.39|0.965
71675724|NCT03793842|142868918|EQUIVALENCE|Equivalence margin 1 J/min||||||0.002|||||||t-test, 2 sided|||||||.002
71675725|NCT03793842|142868919|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71675726|NCT03793842|142868920|EQUIVALENCE|Equivalence margin 1 cm H20|Mean Difference (Net)|0.05||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
71675727|NCT03793842|142868921|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71675728|NCT03793842|142868922|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71805808|NCT02105948|143111892|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|0.2|||=|0.901|TWO_SIDED|95.0|-2.8|3.2||Unadjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||3.2|-2.8|=0.901
71805809|NCT02105948|143111893|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||>|0.999|TWO_SIDED|95.0|-2.0|0.5||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|>0.999
71805810|NCT02105948|143111893|SUPERIORITY||Mean Difference (Mepolizumab - Placebo)|-0.8|||=|0.244|TWO_SIDED|95.0|-2.0|0.5||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.5|-2.0|=0.244
71805811|NCT02105948|143111894|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||>|0.999|TWO_SIDED|95.0|0.75|1.05||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|>0.999
71805812|NCT02105948|143111894|SUPERIORITY||Hazard ratio (Mepolizumab/Placebo)|0.89|||=|0.16|TWO_SIDED|95.0|0.75|1.05||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status|||1.05|0.75|=0.160
71805813|NCT02105948|143111895|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||>|0.999|TWO_SIDED|95.0|0.81|1.49||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|>0.999
71842296|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|1.52||||0.195|TWO_SIDED|95.0|-0.79|3.82||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 1.30|Difference between the changes (EX+T - EX+P)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.82|-0.79|0.195
71842297|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.418|TWO_SIDED|95.0|-1.93|4.63||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = 0.81|Difference between the changes (EX+T - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||4.63|-1.93|0.418
71842298|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.921|TWO_SIDED|95.0|-3.46|3.13||Unadjusted p-value|Mixed Models Analysis|t (df, 233) = -0.10|Difference between the changes (EX+P - EUC)|Comparison of Physical Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous Toeplitz covariance structure in the model with covariates.||3.13|-3.46|0.921
71894416|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|0.88|||||TWO_SIDED|95.0|0.65|1.19||||||Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.19|0.65|
71675729|NCT01075256|142869030|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1||||0.3628|TWO_SIDED|95.0|-6.7|2.46||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||2.46|-6.70|0.3628
71805814|NCT02105948|143111895|SUPERIORITY||Rate ratio (mepolizumab/placebo)|1.1|||=|0.556|TWO_SIDED|95.0|0.81|1.49||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).|||1.49|0.81|=0.556
71805815|NCT02105948|143111896|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||>|0.999|TWO_SIDED|95.0|-1.5|2.9||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|>0.999
71842299|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.078|TWO_SIDED|95.0|-0.26|4.88||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.77|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||4.88|-0.26|0.078
71842300|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.982|TWO_SIDED|95.0|-3.51|3.43||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.02|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.43|-3.51|0.982
71842301|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.35||||0.187|TWO_SIDED|95.0|-5.85|1.15||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.32|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||1.15|-5.85|0.187
71842302|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|2.16||||0.08|TWO_SIDED|95.0|-0.26|4.58||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.76|Difference of the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||4.58|-0.26|0.080
71894417|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.33|0.74|
71894418|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|0.84|||||TWO_SIDED|95.0|0.64|1.11||||||Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.||1.11|0.64|
71805816|NCT02105948|143111896|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|0.7|||=|0.532|TWO_SIDED|95.0|-1.5|2.9||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||2.9|-1.5|=0.532
71805817|NCT02105948|143111897|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||>|0.999|TWO_SIDED|95.0|-1.5|0.4||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|>0.999
71805818|NCT02105948|143111897|SUPERIORITY||Mean difference (Mepolizumab - Placebo)|-0.6|||=|0.252|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.|||0.4|-1.5|=0.252
71805819|NCT01934218|143111898|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.7|2.7|||Basic longitudinal model|||||2.7|-2.7|0.988
71805820|NCT01934218|143111899|OTHER|Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.||||||||||||||||A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.|Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).|||
71805821|NCT02232893|143111900|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71805822|NCT05003791|143111913|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
71805823|NCT05003791|143111914|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
71805824|NCT05003791|143111915|OTHER|This was a cross-sectional design|||||<|0.05|||||||Regression, Linear|||||||<0.05
71805825|NCT01365494|143111943|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667|Ratio of GMCs-Zagreb and Essen at day 14|1.03|||||TWO_SIDED|95.0|0.89|1.19|||ANOVA|||To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14||1.19|0.89|
71842303|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.781|TWO_SIDED|95.0|-3.76|2.83||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.28|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.83|-3.76|0.781
71805826|NCT01365494|143111945|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 7|0.38|||||TWO_SIDED|95.0|0.3|0.48|||ANOVA|||||0.48|0.3|
71842304|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.63||||0.121|TWO_SIDED|95.0|-5.94|0.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.56|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to six months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.69|-5.94|0.121
71805827|NCT01365494|143111945|SUPERIORITY_OR_OTHER||Ratio of GMCs-Zagreb and Essen at day 42|0.96||||||95.0|0.86|1.07|||ANOVA|||||1.07|0.86|
71805828|NCT00718718|143111947|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
71805829|NCT00718718|143111947|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cochran-Mantel-Haenszel|||||||0.052
71805830|NCT00718718|143111947|SUPERIORITY_OR_OTHER|||||||0.026|||||||Cochran-Mantel-Haenszel|||||||0.026
71805831|NCT00718718|143111947|SUPERIORITY_OR_OTHER|||||||0.104|||||||Cochran-Mantel-Haenszel|||||||0.104
71805832|NCT00718718|143111948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
71805833|NCT00718718|143111948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
71805834|NCT00718718|143111948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
71805835|NCT00718718|143111948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
71805836|NCT00718718|143111948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Van Der Waerden ANOVA|||||||< 0.001
71805837|NCT00718718|143111949|SUPERIORITY_OR_OTHER|||||||0.148|||||||Cochran-Mantel-Haenszel|||||||0.148
71805838|NCT01462344|143111968|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value \<0.025.|Hazard Ratio (HR)|1.285||||0.006|TWO_SIDED|95.0|0.726|2.272|||Regression, Cox||Estimated for Hazard ratio|||2.272|0.726|0.006
71805839|NCT01462344|143111968|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0019|||||TWO_SIDED|95.0|-0.0024|0.0063|||||Estimated for Absolute risk difference|||0.0063|-0.0024|
71805840|NCT01462344|143111969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859|||||TWO_SIDED|95.0|0.729|1.012|||||Estimated for Hazard ratio|||1.012|0.729|
71805841|NCT03086447|143112008|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agresti-Coull||All eyes (100%) in the Test group had acceptable VA throughout the study.|Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.||100|96.5|
71675730|NCT01075256|142869030|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.9361|TWO_SIDED|95.0|-4.45|4.83||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.83|-4.45|0.9361
71805842|NCT03086447|143112009|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens fit with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable lens fit at fitting (visit 1).|Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
71805843|NCT03086447|143112010|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens stability with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||TWO_SIDED|95.0|96.5|100.0||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Binomial proportion with Agrestic-Coull||All eyes (100%) in the Test group had acceptable stability at fitting.|Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||100.0|96.5|
71813580|NCT04858802|143129484|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.64||0.132|TWO_SIDED|95.0|-0.3|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 90||0.0|-0.3|0.132
71813581|NCT04858802|143129484|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.79||0.31|TWO_SIDED|95.0|-0.3|0.1|||t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean adhesion/scarring grade in the ethmoid sinus minus balloon sinus dilation alone mean adhesion/scarring grade in the ethmoid sinus|Day 180||0.1|-0.3|0.310
71813582|NCT04858802|143129485|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.48||0.666|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 21||0.1|-0.2|0.666
71894419|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.46|||||TWO_SIDED|95.0|1.03|2.05||||||Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||2.05|1.03|
71894420|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.0|||||TWO_SIDED|95.0|0.81|1.24||||||Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.24|0.81|
71675731|NCT01075256|142869030|SUPERIORITY_OR_OTHER||Adjusted Mean difference|2.3||||0.3257|TWO_SIDED|95.0|-2.31|6.92||No adustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.92|-2.31|0.3257
71675732|NCT01075256|142869031|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.6674|TWO_SIDED|95.0|-5.73|3.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||3.68|-5.73|0.6674
71813583|NCT04858802|143129485|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.46||0.497|TWO_SIDED|95.0|-0.2|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 45||0.1|-0.2|0.497
71813584|NCT04858802|143129485|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.5||0.235|TWO_SIDED|95.0|-0.2|0.0||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 90||0.0|-0.2|0.235
71813585|NCT04858802|143129485|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.41||0.677|TWO_SIDED|95.0|-0.1|0.1||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean polyp grade in the ethmoid sinus minus balloon sinus dilation alone mean polyp grade in the ethmoid sinus|Day 180||0.1|-0.1|0.677
71805844|NCT03086447|143112011|OTHER|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of absolute rotation with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Least square mean proportion|99.6|||||TWO_SIDED|95.0|97.5|99.9||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Linear mixed model with binomial dist.||Above 80% of eyes in the Test group had acceptable rotation.|Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.||99.9|97.5|
71805845|NCT03086447|143112012|OTHER|It was deemed that a total of 135 subjects per each study group is sufficient to demonstrate no statistical difference in the CS incidence rate between the Test and Control groups with a minimum of 80% statistical power using the reference incidence rate of 0.005% with a correlation of 0.3 between eyes within subject.|Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.004|1.437||All primary hypotheses were simultaneously evaluated using a significance level of 0.05 following the intersection-union principal. All primary hypotheses must be met to claim success of the study objectives.|Bayesian beta-binomial model|A 95% credible interval for the posterior estimate (Test over Control) was used to test no difference between the Test and Control groups.|odds ratio calculated as Test over Control|Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.||1.437|0.004|
71805846|NCT03086447|143112013|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|2.39|||TWO_SIDED|95.0|2.1|11.5|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||11.5|2.1|
71805847|NCT03086447|143112014|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|2.04|||TWO_SIDED|95.0|-7.2|0.9|||Linear mixed model|A 95% confidence interval for the least square mean difference was used to demonstrate non-inferiority of the Test relative to the Control groups.|Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.||0.9|-7.2|
71805848|NCT03086447|143112015|NON_INFERIORITY|A non-inferiority margin of 0.5 was used. This margin is based on a 10% difference in the distribution between the Test and Control groups.|Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.98|3.22|||Generalized LMM w/ binomial dist.||Odds ratio of Test over Control was calculated.|Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.||3.22|0.98|
71805849|NCT03394924|143112028|SUPERIORITY||Odds Ratio (OR)|5.6||||0.106|TWO_SIDED|95.0|0.6|52.0|||Cochran-Mantel-Haenszel|||||52|0.6|0.106
71805850|NCT03394924|143112028|SUPERIORITY||Odds Ratio (OR)|7.0||||0.063|TWO_SIDED|95.0|0.75|65.22|||Cochran-Mantel-Haenszel|||||65.22|0.75|0.063
71805851|NCT03394924|143112032|SUPERIORITY||Least squares mean difference|0.47||||0.616|TWO_SIDED|95.0|-1.39|2.32|||ANCOVA|||Analysis for total bilirubin.||2.32|-1.39|0.616
71805852|NCT03394924|143112032|SUPERIORITY||Least squares mean difference|0.19||||0.844|TWO_SIDED|95.0|-1.78|2.16|||ANCOVA|||Analysis for total bilirubin.||2.16|-1.78|0.844
71842305|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|1.58||||0.148|TWO_SIDED|95.0|-0.57|3.73||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.45|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||3.73|-0.57|0.148
71842306|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.699|TWO_SIDED|95.0|-3.64|2.45||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.39|Differences between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||2.45|-3.64|0.699
71675733|NCT01075256|142869031|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9888|TWO_SIDED|95.0|-4.74|4.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||4.81|-4.74|0.9888
71842307|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.18||||0.163|TWO_SIDED|95.0|-5.24|0.89||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.4|Difference in the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure.||0.89|-5.24|0.163
71842308|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|1.59||||0.137|TWO_SIDED|95.0|-0.51|3.69||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = 1.49|Difference between the changes (EX+T - EX+P)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||3.69|-0.51|0.137
71805853|NCT03394924|143112032|SUPERIORITY||Least squares mean difference|-0.67||||0.18|TWO_SIDED|95.0|-1.67|0.32|||ANCOVA|||Analysis for conjugated bilirubin.||0.32|-1.67|0.18
71805854|NCT03394924|143112032|SUPERIORITY||Least squares mean difference|-0.64||||0.239|TWO_SIDED|95.0|-1.71|0.44|||ANCOVA|||Analysis for conjugated bilirubin.||0.44|-1.71|0.239
71805855|NCT03394924|143112032|SUPERIORITY||Least squares mean difference|1.21||||0.116|TWO_SIDED|95.0|-0.31|2.73|||ANCOVA|||Analysis for unconjugated bilirubin.||2.73|-0.31|0.116
71842309|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.648|TWO_SIDED|95.0|-3.68|2.29||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -0.46|Difference between the changes (EX+T - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||2.29|-3.68|0.648
71842310|NCT02938923|143195823|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.135|TWO_SIDED|95.0|-5.29|0.72||Unadjusted p-value|Mixed Models Analysis|t (df, 232) = -1.50|Difference between the changes (EX+P - EUC)|Comparison of Mental Health Domain based on contrasts between two groups at baseline to three months from mixed model ANOVA with a Heterogeneous AR Autoregressive (1) covariance structure in the model with covariates.||0.72|-5.29|0.135
71805856|NCT03394924|143112032|SUPERIORITY||Least squares mean difference|0.72||||0.36|TWO_SIDED|95.0|-0.84|2.28|||ANCOVA|||Analysis for unconjugated bilirubin.||2.28|-0.84|0.36
71842311|NCT02938923|143195824|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.821|TWO_SIDED|95.0|-0.073|0.058||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.23|Difference between the changes (EX+T - EX+P)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.058|-0.073|0.821
71842312|NCT02938923|143195824|SUPERIORITY||Mean Difference (Final Values)|0.013||||0.789|TWO_SIDED|95.0|-0.082|0.108||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.27|Difference between the changes (EX+T - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.108|-0.082|0.789
71805857|NCT03394924|143112033|SUPERIORITY||Least squares mean difference|-25.55||||0.001|TWO_SIDED|95.0|-40.07|-11.04|||ANCOVA|||Analysis for ALT.||-11.04|-40.07|0.001
71805858|NCT03394924|143112033|SUPERIORITY||Least squares mean difference|-21.35||||0.009|TWO_SIDED|95.0|-37.1|-5.6|||ANCOVA|||Analysis for ALT.||-5.6|-37.1|0.009
71805859|NCT03394924|143112033|SUPERIORITY||Least squares mean difference|-21.42||||0|TWO_SIDED|95.0|-32.48|-10.35|||ANCOVA|||Analysis for AST.||-10.35|-32.48|0.000
71805860|NCT03394924|143112033|SUPERIORITY||Least squares mean difference|-20.84||||0.001|TWO_SIDED|95.0|-32.8|-8.87|||ANCOVA|||Analysis for AST.||-8.87|-32.8|0.001
71805861|NCT03394924|143112033|SUPERIORITY||Least squares mean difference|-86.49||||0|TWO_SIDED|95.0|-123.78|-49.21|||ANCOVA|||Analysis for GGT.||-49.21|-123.78|0.000
71805862|NCT03394924|143112033|SUPERIORITY||Least squares mean difference|-115.13||||0|TWO_SIDED|95.0|-155.04|-75.22|||ANCOVA|||Analysis for GGT.||-75.22|-155.04|0.000
71842313|NCT02938923|143195824|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.672|TWO_SIDED|95.0|-0.075|0.116||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.42|Difference between the changes (EX+P - EUC)|Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive AR(1) covariance structure.||0.116|-0.075|0.672
71842314|NCT02938923|143195824|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.703|TWO_SIDED|95.0|-0.013|0.009||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.38||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EX+P)|0.009|-0.013|0.703
71842315|NCT02938923|143195824|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.803|TWO_SIDED|95.0|-0.017|0.014||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = -0.25||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+T - EUC)|0.014|-0.017|0.803
71842316|NCT02938923|143195824|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.015|0.016||Unadjusted p-value|Mixed Models Analysis|t (df, 92) = 0.01||Comparison based on contrasts between two groups at baseline to six months from mixed model ANOVA with an Autoregressive (1) covariance structure in the model with covariates.|Difference between the changes (EX+P - EUC)|0.016|-0.015|0.991
71842317|NCT05932407|143195834|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|2.0||||||Crude hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Crude hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||2.0|0.1|
71805863|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-26.66||||0.148|TWO_SIDED|95.0|-63.1|9.79|||ANCOVA|||Analysis for HA.||9.79|-63.1|0.148
71805864|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-28.99||||0.142|TWO_SIDED|95.0|-68.02|10.05|||ANCOVA|||Analysis for HA.||10.05|-68.02|0.142
71805865|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-3.09||||0.02|TWO_SIDED|95.0|-5.68|-0.51|||ANCOVA|||Analysis for PIIINP.||-0.51|-5.68|0.02
71805866|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-3.79||||0.009|TWO_SIDED|95.0|-6.6|-0.97|||ANCOVA|||Analysis for PIIINP.||-0.97|-6.6|0.009
71805867|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-41.96||||0.015|TWO_SIDED|95.0|-75.47|-8.44|||ANCOVA|||Analysis for TIMP 1.||-8.44|-75.47|0.015
71805868|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-46.56||||0.011|TWO_SIDED|95.0|-81.91|-11.21|||ANCOVA|||Analysis for TIMP 1.||-11.21|-81.91|0.011
71805869|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-9.73||||0.018|TWO_SIDED|95.0|-17.7|-1.75|||ANCOVA|||Analysis for PRO C3.||-1.75|-17.7|0.018
71805870|NCT03394924|143112034|SUPERIORITY||Least squares mean difference|-6.73||||0.125|TWO_SIDED|95.0|-15.41|1.95|||ANCOVA|||Analysis for PRO C3.||1.95|-15.41|0.125
71805871|NCT03394924|143112035|SUPERIORITY||Least squares mean difference|-0.37||||0|TWO_SIDED|95.0|-0.56|-0.18|||ANCOVA|||||-0.18|-0.56|0.000
71805872|NCT03394924|143112035|SUPERIORITY||Least squares mean difference|-0.33||||0.002|TWO_SIDED|95.0|-0.54|-0.13|||ANCOVA|||||-0.13|-0.54|0.002
71805873|NCT03394924|143112036|SUPERIORITY||Least squares mean difference|-0.35||||0.026|TWO_SIDED|95.0|-0.65|-0.04|||ANCOVA|||||-0.04|-0.65|0.026
71805874|NCT03394924|143112036|SUPERIORITY||Least squares mean difference|-0.26||||0.104|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||||0.05|-0.57|0.104
71805875|NCT03394924|143112037|SUPERIORITY||Least squares mean difference|6.81||||0.757|TWO_SIDED|95.0|-37.17|50.78|||ANCOVA|||Analysis for fibrinogen.||50.78|-37.17|0.757
71842318|NCT05932407|143195834|SUPERIORITY|Adjusted hazard ratio was adjusted from crude hazard ratio by covariance 1 (age and gender), and covariance 2 (antithrombotic drug administration, NSAID administration, and hypertension).|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.1|1.9||||||Adjusted hazard ratio of Vortioxetine Tablets to SSRIs for intracranial hemorrhage was reported. Adjusted hazard ratio of Vortioxetine Tablet Treatment group relative to the control group (SSRI Treatment group) was calculated by the rate of Vortioxetine Tablet Treatment group divided by the rate of SSRI Treatment group.||1.9|0.1|
71842319|NCT04181736|143195840|OTHER||F-statistic|6.621||||0.02|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for circuit function, with five repeated measures for each circuit measure defining the cognitive control circuit.||||0.020
71842320|NCT04181736|143195845|OTHER||Cohen's d effect size|1.47|||<|0.001|TWO_SIDED|95.0|0.937|2.002||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to week 2.||2.002|0.937|<0.001
71842321|NCT04181736|143195845|OTHER||Cohen's d effect size|3.152|||<|0.001|TWO_SIDED|95.0|2.757|3.547||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in HDRS-17 depression scores from pre-treatment to post-treatment sessions.||3.547|2.757|<0.001
71842322|NCT04181736|143195846|OTHER||Cohen's d effect size|-1.249|||<|0.001|TWO_SIDED|95.0|-1.724|-0.774||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in QIDS-SR depression scores from pre-treatment to post-treatment sessions.||-0.774|-1.724|< 0.001
71842323|NCT04181736|143195847|OTHER||F-statistic|19.362|||<|0.001|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for cognitive control function, with six repeated measures for behavioral tests of cognitive control.||||<0.001
71842324|NCT04181736|143195848|OTHER||Cohen's d effect size|0.881||||0.002|TWO_SIDED|95.0|0.324|1.438||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in SWLS scores from pre-treatment to post-treatment sessions.||1.438|0.324|0.002
71842325|NCT04181736|143195849|OTHER||F-statistic|11.913||||0.003|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Repeated Measures General Linear Model|||Test of the effect of guanfacine using a general linear model including a within subjects' effect for treatment (pre- versus post-treatment sessions) and for quality with four repeated measures for domains of quality of life.||||0.003
71842326|NCT04181736|143195850|OTHER||Cohen's d effect size|-0.2||||0.283|TWO_SIDED|95.0|-0.608|0.208||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||A paired t-test was conducted to evaluate the effect of GIR on changes in C-SSRS scores from pre-treatment to post-treatment sessions.||0.208|-0.608|0.283
71842327|NCT02518048|143195863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.17|||<|0.001|TWO_SIDED|95.0|-2.58|-1.76||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).|ANOVA|||A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values.||-1.76|-2.58|<0.001
71842328|NCT02518048|143195866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.53|-0.32||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Total Skin Thickness: LEO 90100 vs. Betesil®||-0.32|-0.53|<0.001
71894421|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.36|||||TWO_SIDED|95.0|1.02|1.82||||||Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.82|1.02|
71842329|NCT02518048|143195866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|||<|0.001|TWO_SIDED|95.0|-0.69|-0.41||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Echo-Poor Band Thickness: LEO 90100 vs. Betesil®||-0.41|-0.69|<0.001
71842330|NCT04505410|143195867|OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71842331|NCT01586910|143195870|NON_INFERIORITY|Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971|Posterior Median of the Difference|-1.4|||||TWO_SIDED|||||The posterior probability of non-inferiority is \> 0.9999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.||||
71842332|NCT02278211|143195926|OTHER||Hazard Ratio (HR)|1.25||||0.2|TWO_SIDED|95.0|0.89|1.76|||Log Rank|||||1.76|0.89|0.20
71842333|NCT02278211|143195927|OTHER||Hazard Ratio (HR)|2.43||||0.02|TWO_SIDED|95.0|1.15|5.12|||Log Rank|||||5.12|1.15|0.02
71894422|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|0.96|||||TWO_SIDED|95.0|0.78|1.18||||||Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.18|0.78|
71842334|NCT05970861|143195947|OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||"Null hypothesis: there is no statistical significance between the mean percentages of microbiota units of the main and control groups after the mare's milk administration.~Alternate hypothesis: statistical significance exists between the mean percentages of microbiota units of the main and control groups after the mare's milk administration."||||<0.05
71842335|NCT05970861|143195947|OTHER||||||<|0.05|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the mean percentages of gut microbiota units.~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the mean percentages of gut microbiota units."||||<0.05
71842336|NCT05970861|143195948|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between antiphospholipid antibody levels before and after the mare's milk administration."||||>0.05
71842337|NCT05970861|143195949|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||"Null hypothesis: No statistically significant difference exists between uric acid blood levels before and after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between uric acid blood levels before and after the mare's milk administration."||||0.01
71842338|NCT05970861|143195950|OTHER||||||<|0.01|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after the mare's milk administration."||||<0.01
71842339|NCT05970861|143195950|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Null hypothesis: No statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group.~Alternate hypothesis: Statistically significant difference exists between the scores on a scale (PCS, MCS) after 2 measurements in the control group."||||>0.05
71842340|NCT05970861|143195950|OTHER||||||<|0.01|||||||ANOVA|||"Null Hypothesis: The freeze-dried mare's milk does not significantly influence the scores on the scales (PCS, MCS).~Alternate Hypothesis: The freeze-dried mare's milk significantly influences the scores on the scales (PCS, MCS)."||||<0.01
71842341|NCT04778410|143195968|SUPERIORITY|||||||0.1794|||||||One Group Chi-Square test|The p-value was based on one group Chi-Square test for the null hypothesis CR rate was 0.19 at one-sided alpha of 0.1 in Cohort 2.||||||0.1794
71805876|NCT03394924|143112037|SUPERIORITY||Least squares mean difference|31.77||||0.174|TWO_SIDED|95.0|-14.42|77.97|||ANCOVA|||Analysis for fibrinogen.||77.97|-14.42|0.174
71842342|NCT00677365|143196009|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.96||||0.0014|TWO_SIDED|95.0|-1.54|-0.38||Repeated Measure Model|Mixed Models Analysis|||LS Mean Difference||-0.38|-1.54|0.0014
71842343|NCT00677365|143196010|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.21||||0.0007|TWO_SIDED|95.0|0.09|0.52|||Regression, Cox|||Hazard Ratio for need of anti-pseudomonal antimicrobials; Estimates are obtained from a Cox proportional hazards regression model including terms for treatment, region, baseline P.aeruginosa density (log10 ), highest baseline MIC of levofloxacin against P. aeruginosa (log2 ), and baseline percent predicted FEV1 (quartiles)||0.52|0.09|0.0007
71842344|NCT00677365|143196011|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.61||||0.0026|TWO_SIDED|95.0|3.05|14.17|||Mixed Models Analysis|||LS Mean Difference Between MP-376 240 mg and Placebo groups||14.17|3.05|0.0026
71805877|NCT03394924|143112037|SUPERIORITY||Least squares mean difference|-0.98||||0.378|TWO_SIDED|95.0|-3.18|1.23|||ANCOVA|||Analysis for CRP.||1.23|-3.18|0.378
71805878|NCT03394924|143112037|SUPERIORITY||Least squares mean difference|-3.1||||0.008|TWO_SIDED|95.0|-5.38|-0.83|||ANCOVA|||Analysis for CRP.||-0.83|-5.38|0.008
71805879|NCT03394924|143112038|SUPERIORITY||Least squares mean difference|0.34||||0.841|TWO_SIDED|95.0|-3.07|3.76|||ANCOVA|||Analysis for IL6.||3.76|-3.07|0.841
71805880|NCT03394924|143112038|SUPERIORITY||Least squares mean difference|-2.49||||0.163|TWO_SIDED|95.0|-6.01|1.04|||ANCOVA|||Analysis for IL6.||1.04|-6.01|0.163
71805881|NCT03394924|143112038|SUPERIORITY||Least squares mean difference|-0.53||||0.03|TWO_SIDED|95.0|-1.02|-0.05|||ANCOVA|||Analysis for TNF α.||-0.05|-1.02|0.03
71805882|NCT03394924|143112038|SUPERIORITY||Least squares mean difference|-0.4||||0.11|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Analysis for TNF α.||0.09|-0.9|0.11
71805883|NCT03394924|143112039|SUPERIORITY||Least squares mean difference|0.01||||0.944|TWO_SIDED|95.0|-0.25|0.27|||ANCOVA|||Analysis for haptoglobin.||0.27|-0.25|0.944
71805884|NCT03394924|143112039|SUPERIORITY||Least squares mean difference|-0.03||||0.83|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Analysis for haptoglobin.||0.24|-0.3|0.83
71842345|NCT00677365|143196012|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.94||||0.0008|TWO_SIDED|95.0|4.63|17.25|||Mixed Models Analysis|||LS Mean Difference Between Placebo and MP-376 240 mg BID groups||17.25|4.63|0.0008
71842346|NCT00677365|143196013|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5||||0.2174|TWO_SIDED|95.0|-2.68|11.67|||Mixed Models Analysis|||LS Mean Difference from MP-376 240 mg BID to placebo groups||11.67|-2.68|0.2174
71842347|NCT02542631|143196017|NON_INFERIORITY|The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.32|0.14||Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.14|-0.32|<0.0001
71842348|NCT02542631|143196018|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.25||0.26|TWO_SIDED|95.0|0.81|2.14||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||2.14|0.81|0.26
71675734|NCT01075256|142869031|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.1||||0.6599|TWO_SIDED|95.0|-3.69|5.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.81|-3.69|0.6599
71805885|NCT03394924|143112039|SUPERIORITY||Least squares mean difference|-0.04||||0.546|TWO_SIDED|95.0|-0.19|0.1|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.1|-0.19|0.546
71805886|NCT03394924|143112039|SUPERIORITY||Least squares mean difference|-0.02||||0.785|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||Analysis for alpha2 macroglobulin.||0.13|-0.18|0.785
71805887|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.17||||0.176|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Analysis for TG.||0.08|-0.43|0.176
71805888|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.04||||0.783|TWO_SIDED|95.0|-0.3|0.23|||ANCOVA|||Analysis for TG.||0.23|-0.3|0.783
71805889|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.64||||0.061|TWO_SIDED|95.0|-1.31|0.03|||ANCOVA|||Analysis for TC.||0.03|-1.31|0.061
71805890|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.63||||0.08|TWO_SIDED|95.0|-1.34|0.08|||ANCOVA|||Analysis for TC.||0.08|-1.34|0.08
71805891|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|0.08||||0.584|TWO_SIDED|95.0|-0.21|0.37|||ANCOVA|||Analysis for HDL-C.||0.37|-0.21|0.584
71805892|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.22||||0.148|TWO_SIDED|95.0|-0.51|0.08|||ANCOVA|||Analysis for HDL-C.||0.08|-0.51|0.148
71805893|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.5||||0.074|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Analysis for LDL-C.||0.05|-1.04|0.074
71805894|NCT03394924|143112040|SUPERIORITY||Least squares mean difference|-0.3||||0.304|TWO_SIDED|95.0|-0.87|0.28|||ANCOVA|||Analysis for LDL-C.||0.28|-0.87|0.304
71805895|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|0.25||||0.378|TWO_SIDED|95.0|-0.32|0.82|||ANCOVA|||Analysis for duration.||0.82|-0.32|0.378
71805896|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|0.65||||0.03|TWO_SIDED|95.0|0.07|1.23|||ANCOVA|||Analysis for duration.||1.23|0.07|0.03
71805897|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|0.53||||0.036|TWO_SIDED|95.0|0.04|1.03|||ANCOVA|||Analysis for degree.||1.03|0.04|0.036
71842349|NCT02542631|143196019|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|3.36||0.38|TWO_SIDED|95.0|-9.63|3.7||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||3.70|-9.63|0.38
71842350|NCT02542631|143196020|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.99|TWO_SIDED|95.0|-0.28|0.28||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.||||0.28|-0.28|0.99
71805898|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|1.18||||0|TWO_SIDED|95.0|0.67|1.69|||ANCOVA|||Analysis for degree.||1.69|0.67|0.000
71805899|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|0.02||||0.971|TWO_SIDED|95.0|-0.92|0.96|||ANCOVA|||Analysis for direction.||0.96|-0.92|0.971
71805900|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|1.01||||0.042|TWO_SIDED|95.0|0.04|1.99|||ANCOVA|||Analysis for direction.||1.99|0.04|0.042
71805901|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|0.37||||0.336|TWO_SIDED|95.0|-0.4|1.14|||ANCOVA|||Analysis for disability.||1.14|-0.4|0.336
71805902|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|1.46||||0|TWO_SIDED|95.0|0.67|2.26|||ANCOVA|||Analysis for disability.||2.26|0.67|0.000
71805903|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|0.48||||0.214|TWO_SIDED|95.0|-0.29|1.25|||ANCOVA|||Analysis for distribution.||1.25|-0.29|0.214
71805904|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|1.23||||0.003|TWO_SIDED|95.0|0.44|2.02|||ANCOVA|||Analysis for distribution.||2.02|0.44|0.003
71805905|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|2.21||||0.103|TWO_SIDED|95.0|-0.47|4.9|||ANCOVA|||Analysis for total.||4.9|-0.47|0.103
71805906|NCT03394924|143112041|SUPERIORITY||Least squares mean difference|6.35||||0|TWO_SIDED|95.0|3.57|9.13|||ANCOVA|||Analysis for total.||9.13|3.57|0.000
71805907|NCT03394924|143112042|SUPERIORITY||Least squares mean difference|12.48||||0.16|TWO_SIDED|95.0|-5.09|30.06|||ANCOVA|||||30.06|-5.09|0.16
71805908|NCT03394924|143112042|SUPERIORITY||Least squares mean difference|25.58||||0.006|TWO_SIDED|95.0|7.67|43.48|||ANCOVA|||||43.48|7.67|0.006
71805909|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-0.15||||0.908|TWO_SIDED|95.0|-2.72|2.43|||ANCOVA|||Analysis for symptoms.||2.43|-2.72|0.908
71805910|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-1.41||||0.298|TWO_SIDED|95.0|-4.09|1.27|||ANCOVA|||Analysis for symptoms.||1.27|-4.09|0.298
71805911|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|1.91||||0.042|TWO_SIDED|95.0|0.07|3.76|||ANCOVA|||Analysis for itch.||3.76|0.07|0.042
71805912|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|3.47||||0.001|TWO_SIDED|95.0|1.55|5.38|||ANCOVA|||Analysis for itch.||5.38|1.55|0.001
71805913|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-0.46||||0.839|TWO_SIDED|95.0|-4.96|4.04|||ANCOVA|||Analysis for fatigue.||4.04|-4.96|0.839
71805914|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-0.32||||0.891|TWO_SIDED|95.0|-5.0|4.36|||ANCOVA|||Analysis for fatigue.||4.36|-5.00|0.891
71805915|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|0.26||||0.834|TWO_SIDED|95.0|-2.25|2.77|||ANCOVA|||Analysis for cognition.||2.77|-2.25|0.834
71805916|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|1.3||||0.327|TWO_SIDED|95.0|-1.33|3.92|||ANCOVA|||Analysis for cognition.||3.92|-1.33|0.327
71842351|NCT02542631|143196021|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.28||0.71|TWO_SIDED|95.0|0.64|1.93||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel|||||1.93|0.64|0.71
71675735|NCT01075256|142869032|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1||||0.9759|TWO_SIDED|95.0|-6.34|6.54||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.54|-6.34|0.9759
71675736|NCT01075256|142869032|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.8903|TWO_SIDED|95.0|-6.97|6.06||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.06|-6.97|0.8903
71675737|NCT01075256|142869032|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6||||0.8662|TWO_SIDED|95.0|-7.04|5.93||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.||5.93|-7.04|0.8662
71675738|NCT01075256|142869033|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.6||||0.8419|TWO_SIDED|95.0|-6.93|5.66||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||5.66|-6.93|0.8419
71675739|NCT01075256|142869033|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.9147|TWO_SIDED|95.0|-6.03|6.72||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.72|-6.03|0.9147
71805917|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-2.12||||0.262|TWO_SIDED|95.0|-5.86|1.62|||ANCOVA|||Analysis for social.||1.62|-5.86|0.262
71805918|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-0.78||||0.69|TWO_SIDED|95.0|-4.68|3.12|||ANCOVA|||Analysis for social.||3.12|-4.68|0.69
71805919|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|-0.62||||0.433|TWO_SIDED|95.0|-2.19|0.95|||ANCOVA|||Analysis for emotional.||0.95|-2.19|0.433
71805920|NCT03394924|143112043|SUPERIORITY||Least squares mean difference|0.37||||0.653|TWO_SIDED|95.0|-1.28|2.03|||ANCOVA|||Analysis for emotional.||2.03|-1.28|0.653
71805921|NCT03394924|143112047|SUPERIORITY||Least squares mean difference|1.34||||0.971|TWO_SIDED|95.0|-71.51|74.18|||ANCOVA|||Analysis for FGF19.||74.18|-71.51|0.971
71805922|NCT03394924|143112047|SUPERIORITY||Least squares mean difference|5.54||||0.882|TWO_SIDED|95.0|-68.86|79.95|||ANCOVA|||Analysis for FGF19.||79.95|-68.86|0.882
71805923|NCT03394924|143112047|SUPERIORITY||Least squares mean difference|-51.66||||0.242|TWO_SIDED|95.0|-139.27|35.96|||ANCOVA|||Analysis for C4.||35.96|-139.27|0.242
71842352|NCT02542631|143196022|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.52|TWO_SIDED|95.0|-0.12|0.24||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.||||0.24|-0.12|0.52
71805924|NCT03394924|143112047|SUPERIORITY||Least squares mean difference|-94.3||||0.042|TWO_SIDED|95.0|-184.85|-3.75|||ANCOVA|||Analysis for C4.||-3.75|-184.85|0.042
71805925|NCT03394924|143112047|SUPERIORITY||Least squares mean difference|-24.57||||0.52|TWO_SIDED|95.0|-101.03|51.89|||ANCOVA|||Analysis for BA.||51.89|-101.03|0.52
71805926|NCT03394924|143112047|SUPERIORITY||Least squares mean difference|-17.96||||0.672|TWO_SIDED|95.0|-103.07|67.16|||ANCOVA|||Analysis for BA.||67.16|-103.07|0.672
71805927|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|44.54||||0.611|TWO_SIDED|95.0|-205.97|295.06|||ANCOVA|||Analysis for FGF19 AUC0-8.||295.06|-205.97|0.611
71805928|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-29.98||||0.819|TWO_SIDED|95.0|-411.28|351.31|||ANCOVA|||Analysis for FGF19 AUC0-8.||351.31|-411.28|0.819
71805929|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|24.41||||0.818|TWO_SIDED|95.0|-251.92|300.74|||ANCOVA|||Analysis for FGF19 AUC2-8.||300.74|-251.92|0.818
71805930|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-10.53||||0.948|TWO_SIDED|95.0|-435.33|414.27|||ANCOVA|||Analysis for FGF19 AUC2-8.||414.27|-435.33|0.948
71805931|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-91.7||||0.412|TWO_SIDED|95.0|-475.92|292.51|||ANCOVA|||Analysis for C4 AUC0-8.||292.51|-475.92|0.412
71805932|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-250.18||||0.094|TWO_SIDED|95.0|-605.33|104.98|||ANCOVA|||Analysis for C4 AUC0-8.||104.98|-605.33|0.094
71805933|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-83.7||||0.266|TWO_SIDED|95.0|-279.15|111.75|||ANCOVA|||Analysis for C4 AUC2-8.||111.75|-279.15|0.266
71805934|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-238.19||||0.047|TWO_SIDED|95.0|-470.22|-6.15|||ANCOVA|||Analysis for C4 AUC2-8.||-6.15|-470.22|0.047
71805935|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|28.41||||0.694|TWO_SIDED|95.0|-180.2|237.02|||ANCOVA|||Analysis for BA AUC0-8.||237.02|-180.2|0.694
71805936|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-39.5||||0.615|TWO_SIDED|95.0|-264.32|185.32|||ANCOVA|||Analysis for BA AUC0-8.||185.32|-264.32|0.615
71805937|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|2.93||||0.974|TWO_SIDED|95.0|-229.6|235.46|||ANCOVA|||Analysis for BA AUC2-8.||235.46|-229.6|0.974
71805938|NCT03394924|143112048|SUPERIORITY||Least squares mean difference|-26.05||||0.793|TWO_SIDED|95.0|-283.24|231.15|||ANCOVA|||Analysis for BA AUC2-8.||231.15|-283.24|0.793
71675740|NCT01075256|142869033|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0||||0.76|TWO_SIDED|95.0|-5.36|7.33||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.33|-5.36|0.7600
71675741|NCT01075256|142869034|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.5||||0.9124|TWO_SIDED|95.0|-8.28|9.24||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.24|-8.28|0.9124
71675742|NCT01075256|142869034|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.5||||0.9083|TWO_SIDED|95.0|-9.13|8.14||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level||8.14|-9.13|0.9083
71675743|NCT01075256|142869034|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.0||||0.8231|TWO_SIDED|95.0|-9.73|7.77||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||7.77|-9.73|0.8231
71805939|NCT03387852|143112060|SUPERIORITY||Odds ratio|0.423|||=|0.0214|TWO_SIDED|95.0|0.203|0.88|||Regression, Logistic||SAR440340 300 mg vs. Placebo|Odds ratio, 95% confidence interval (CI), and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||0.88|0.203|=0.0214
71805940|NCT03387852|143112060|SUPERIORITY||Odds ratio|0.52|||=|0.0709|TWO_SIDED|95.0|0.256|1.057|||Regression, Logistic||SAR440340 + Dupilumab vs. Placebo|Odds ratio, 95% CI, and p-value derived from logistic regression with treatment, baseline eosinophil strata, region, background ICS dose level at randomization and number of exacerbation events (defined as required use of systemic \[oral and/or parenteral\] steroid treatment, or required hospitalization or emergency room visit) within 1 year prior to screening.||1.057|0.256|=0.0709
71805941|NCT03069482|143112140|SUPERIORITY||Slope|1.063|STANDARD_DEVIATION|3.377|=|0.754|TWO_SIDED||||||ANOVA|||||||=0.754
71805942|NCT03069482|143112141|SUPERIORITY||Risk Ratio (RR)|2.103|STANDARD_DEVIATION|0.369||0.044|TWO_SIDED|95.0|1.2|2.6|||Mixed Models Analysis|Zero inflated negative binomial mixed methods regression.||||2.6|1.2|0.044
71805943|NCT03069482|143112142|OTHER||Percent accrual relative to target N|102.0|||||TWO_SIDED||||||||||The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).|||
71805944|NCT03069482|143112143|OTHER||Percent retention relative to target|98.3|||||TWO_SIDED||||||||||We calculated the percent of retained participants relative to the retention target (N = 62)|||
71805945|NCT03069482|143112144|OTHER||Percent of respondents|58.0|||||TWO_SIDED|||||||||||||
71805946|NCT03069482|143112146|SUPERIORITY||Trimmed mean difference|8.29574|STANDARD_ERROR_OF_MEAN|2.11||0.046|TWO_SIDED|95.0|0.138|16.453|||Yuen's trimmed mean t-test|||||16.453|0.138|0.046
71805947|NCT03069482|143112147|SUPERIORITY||Trimmed mean difference|7.79514|STANDARD_ERROR_OF_MEAN|2.16||0.109|TWO_SIDED|95.0|-1.867|17.457|||Yuen's trimmed means t-test|||||17.457|-1.867|0.109
71842353|NCT02542631|143196023|SUPERIORITY||Mean Difference (Final Values)|9.16|STANDARD_ERROR_OF_MEAN|2.8||0.001|TWO_SIDED|95.0|3.65|14.67||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||14.67|3.65|0.001
71842354|NCT02542631|143196024|SUPERIORITY||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|2.03||0.03|TWO_SIDED|95.0|0.33|8.32||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.||||8.32|0.33|0.03
71805948|NCT03069482|143112148|SUPERIORITY||Trimmed mean difference|2.22222|STANDARD_ERROR_OF_MEAN|1.75||0.50537|TWO_SIDED|95.0|-4.492|8.943|||Yuen's trimmed means t-test|||||8.943|-4.492|0.50537
71805949|NCT03069482|143112149|SUPERIORITY||Trimmed mean difference|5.83333|STANDARD_ERROR_OF_MEAN|2.3||0.27411|TWO_SIDED|95.0|-4.88|16.54|||Yuen's trimmed means t-test|||||16.54|-4.88|0.27411
71805950|NCT04537923|143112195|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.1|||<|0.001|TWO_SIDED|95.0|-1.24|-0.97|||Mixed Models Analysis|||||-0.97|-1.24|<0.001
71805951|NCT04537923|143112196|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-0.89|||<|0.001|TWO_SIDED|95.0|-1.08|-0.7|||Mixed Models Analysis|||||-0.70|-1.08|<0.001
71805952|NCT04537923|143112196|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.11|||<|0.001|TWO_SIDED|95.0|-1.3|-0.92|||Mixed Models Analysis|||||-0.92|-1.30|<0.001
71805953|NCT04537923|143112196|NON_INFERIORITY|0.3% noninferiority margin.|LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.49|-1.11|||Mixed Models Analysis|||||-1.11|-1.49|<0.001
71805954|NCT04537923|143112197|SUPERIORITY||Odds Ratio (OR)|3.13|||<|0.0001|TWO_SIDED|95.0|2.25|4.36|||Regression, Logistic|||||4.36|2.25|<0.0001
71805955|NCT04537923|143112197|SUPERIORITY||Odds Ratio (OR)|6.16|||<|0.0001|TWO_SIDED|95.0|4.27|8.88|||Regression, Logistic|||||8.88|4.27|<0.0001
71842355|NCT02542631|143196025|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71842356|NCT04068792|143196050|OTHER||Mean Difference (Final Values)|-1.03|||||TWO_SIDED|90.0|-4.467|2.416||||||||2.416|-4.467|
71842357|NCT05513937|143196090|SUPERIORITY||Mean difference pre vs post|-15.2|STANDARD_DEVIATION|8.32|<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||||||<0.001
71805956|NCT04537923|143112197|SUPERIORITY||Odds Ratio (OR)|7.94|||<|0.0001|TWO_SIDED|95.0|5.37|11.75|||Regression, Logistic|||||11.75|5.37|<0.0001
71805957|NCT04537923|143112198|SUPERIORITY||LS Mean Difference|-10.7|||<|0.001|TWO_SIDED|95.0|-11.5|-9.9|||Mixed Models Analysis|||||-9.9|-11.5|<0.001
71805958|NCT04537923|143112198|SUPERIORITY||LS Mean Difference|-13.7|||<|0.001|TWO_SIDED|95.0|-14.5|-12.9|||Mixed Models Analysis|||||-12.9|-14.5|<0.001
71805959|NCT04537923|143112198|SUPERIORITY||LS Mean Difference|-15.9|||<|0.001|TWO_SIDED|95.0|-16.7|-15.0|||Mixed Models Analysis|||||-15.0|-16.7|<0.001
71805960|NCT04537923|143112199|SUPERIORITY||LS Mean Difference|-23.2|||<|0.001|TWO_SIDED|95.0|-30.8|-15.7|||Mixed Models Analysis|||||-15.7|-30.8|<0.001
71805961|NCT04537923|143112199|SUPERIORITY||LS Mean Difference|-33.0|||<|0.001|TWO_SIDED|95.0|-40.6|-25.4|||Mixed Models Analysis|||||-25.4|-40.6|<0.001
71805962|NCT04537923|143112199|SUPERIORITY||LS Mean Difference|-31.6|||<|0.001|TWO_SIDED|95.0|-39.3|-23.8|||Mixed Models Analysis|||||-23.8|-39.3|<0.001
71805963|NCT04537923|143112200|SUPERIORITY||LS Mean Difference|-0.9||||0.682|TWO_SIDED|95.0|-5.0|3.3|||Mixed Models Analysis|||||3.3|-5.0|0.682
71805964|NCT04537923|143112200|SUPERIORITY||LS Mean Difference|-5.6||||0.01|TWO_SIDED|95.0|-9.9|-1.4|||Mixed Models Analysis|||||-1.4|-9.9|0.010
71842358|NCT03663205|143196091|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.0054|TWO_SIDED|95.0|0.465|0.912|||One-sided, Log Rank Test||Stratified by stratification factors: disease stage (IIIB or IV) and the level of PD-L1 expression in tumor cells (\>=50%, 1% to 49%, \<1%)|||0.912|0.465|0.0054
71842359|NCT03663205|143196098|OTHER||Least squares mean difference|-2.2|||||TWO_SIDED|95.0|-7.4|3.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 coughing score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in coughing score||3.1|-7.4|
71805965|NCT04537923|143112200|SUPERIORITY||LS Mean Difference|-11.8|||<|0.001|TWO_SIDED|95.0|-16.0|-7.5|||Mixed Models Analysis|||||-7.5|-16.0|<0.001
71805966|NCT04537923|143112201|SUPERIORITY||Odds Ratio (OR)|8.19|||<|0.001|TWO_SIDED|95.0|5.66|11.83|||Regression, Logistic|||||11.83|5.66|<0.001
71805967|NCT04537923|143112201|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|11.44|24.96|||Regression, Logistic|||||24.96|11.44|<0.001
71805968|NCT04537923|143112201|SUPERIORITY||Odds Ratio (OR)|21.85|||<|0.001|TWO_SIDED|95.0|14.49|32.93|||Regression, Logistic|||||32.93|14.49|<0.001
71805969|NCT04537923|143112202|SUPERIORITY||Odds Ratio (OR)|28.25|||<|0.001|TWO_SIDED|95.0|18.36|43.46|||Regression, Logistic|||||43.46|18.36|<0.001
71805970|NCT04537923|143112202|SUPERIORITY||Odds Ratio (OR)|58.9|||<|0.001|TWO_SIDED|95.0|36.76|94.39|||Regression, Logistic|||||94.39|36.76|<0.001
71805971|NCT04537923|143112202|SUPERIORITY||Odds Ratio (OR)|77.76|||<|0.001|TWO_SIDED|95.0|47.49|127.33|||Regression, Logistic|||||127.33|47.49|<0.001
71805972|NCT04537923|143112203|SUPERIORITY||LS Mean Difference|1.5||||0.005|TWO_SIDED|95.0|0.5|2.6|||ANCOVA|||||2.6|0.5|0.005
71805973|NCT04537923|143112203|SUPERIORITY||LS Mean Difference|2.3|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
71805974|NCT04537923|143112203|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.2|3.3|||ANCOVA|||||3.3|1.2|<0.001
71805975|NCT04537923|143112204|SUPERIORITY||LS Mean Difference|1.6||||0.02|TWO_SIDED|95.0|0.3|2.9|||ANCOVA|||||2.9|0.3|0.020
71805976|NCT04537923|143112204|SUPERIORITY||LS Mean Difference|2.8|||<|0.001|TWO_SIDED|95.0|1.5|4.2|||ANCOVA|||||4.2|1.5|<0.001
71805977|NCT04537923|143112204|SUPERIORITY||LS Mean Difference|2.1||||0.004|TWO_SIDED|95.0|0.7|3.5|||ANCOVA|||||3.5|0.7|0.004
71805978|NCT01261611|143112205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport NG and Placebo arms was performed. A total of 210 subjects were included in the analysis.||||<0.0001
71805979|NCT01261611|143112205|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport and Placebo arms was performed. A total of 213 subjects were included in the analysis.||||<0.0001
71805980|NCT01261611|143112205|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|An ANCOVA on the change from baseline with treatment, baseline TWSTRS Total score, BTX status at baseline and pooled centre as explanatory variables had been performed. The non-inferiority margin was 3 points.|LS mean difference|1.532|||||TWO_SIDED|95.0|-0.819|3.883||||||A pre-specified analysis of the LS mean difference between the Dysport NG and Dysport arms was performed. A total of 315 subjects were included in the analysis.||3.883|-0.819|
71805981|NCT02395120|143112226|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.05|TWO_SIDED|95.0|1.21|3.08||We addressed the issue of multiple testing, both multiple comparisons and multiple sites, using a gatekeeper approach. The use of 0.05 alpha level for each test maintained a 0.05 family-wise alpha level for the six tests (three at each site).|Regression, Logistic||||The primary outcome analysis utilized generalized estimating equations (GEE) with a logit link for the binary dental care receipt outcome. The GEE analysis was conducted using dental care receipt outcomes as restorative care alone (ICDAS codes ≥3), as well as combined preventive (i.e. sealants) and restorative care (ICDAS codes ≥1). Models were fit separately to the overall data (all sites combined), the combined EC and WA sites (based on our original plan of two predominantly low-income school districts), and the BD schools alone. Each model included, as covariates, indicator variables for intervention, site (except for the model with BD alone), child grade, and caregiver demographic variables (race, education, marital status). Corresponding estimated odds ratios and 95% Confidence Intervals were computed.|3.08|1.21|<0.05
71805982|NCT00674986|143112229|SUPERIORITY_OR_OTHER||Difference|0.28|STANDARD_ERROR_OF_MEAN|0.14||0.0416|TWO_SIDED|95.0|0.01|0.54|||Fisher Exact|||||0.54|0.01|0.0416
71842360|NCT03663205|143196098|OTHER||Least squares mean difference|-1.2|||||TWO_SIDED|95.0|-4.4|2.1|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 dyspnea score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in dyspnea score||2.1|-4.4|
71675744|NCT01075256|142869035|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.4||||0.5946|TWO_SIDED|95.0|-9.32|16.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||16.09|-9.32|0.5946
71675745|NCT01075256|142869035|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9944|TWO_SIDED|95.0|-12.51|12.6||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||12.60|-12.51|0.9944
71675746|NCT01075256|142869035|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.3||||0.5998|TWO_SIDED|95.0|-16.06|9.38||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.38|-16.06|0.5998
71675747|NCT01075256|142869036|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7952|TWO_SIDED|95.0|-10.51|8.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.09|-10.51|0.7952
71675748|NCT01075256|142869036|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.4||||0.601|TWO_SIDED|95.0|-11.56|6.76||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||6.76|-11.56|0.6010
71675749|NCT01075256|142869036|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.2||||0.7976|TWO_SIDED|95.0|-10.48|8.1||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.10|-10.48|0.7976
71675750|NCT01075256|142869037|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7||||0.906|TWO_SIDED|95.0|-10.38|11.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||11.68|-10.38|0.9060
71675751|NCT01075256|142869037|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7||||0.7575|TWO_SIDED|95.0|-12.63|9.25||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||9.25|-12.63|0.7575
71675752|NCT01075256|142869037|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.3||||0.6727|TWO_SIDED|95.0|-13.42|8.73||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.||8.73|-13.42|0.6727
71675753|NCT02115581|142869039|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.267
71675754|NCT02115581|142869040|SUPERIORITY_OR_OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
71675755|NCT00596817|142869089|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.0035|TWO_SIDED|95.0|1.26|3.21|||Cox-model|Cox-model using an exact method to handle ties||||3.21|1.26|0.0035
71675756|NCT00596817|142869090|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.001|TWO_SIDED|95.0|1.35|3.23||A nominal p-value is provided.|Cox-Model|||||3.23|1.35|0.0010
71675757|NCT00596817|142869091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.66||0.002|TWO_SIDED|95.0|-3.36|-0.77||A nominal p-value is provided.|ANCOVA|||||-0.77|-3.36|0.0020
71675758|NCT00596817|142869092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|0.55||0.0171|TWO_SIDED|95.0|-2.39|-0.24||A nominal p-value is provided.|ANCOVA|||||-0.24|-2.39|0.0171
71675759|NCT00596817|142869093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.6||0.0612|TWO_SIDED|95.0|-2.3|0.05||A nominal p-value is provided.|ANCOVA|||||0.05|-2.30|0.0612
71675760|NCT00596817|142869094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1||0.0002|TWO_SIDED|95.0|-0.57|-0.18||A nominal p-value is provided.|ANCOVA|||||-0.18|-0.57|0.0002
71675761|NCT00596817|142869095|SUPERIORITY_OR_OTHER||Difference|6.35||||0.025|TWO_SIDED|95.0|1.13|11.56||A nominal p-value is provided.|Fisher Exact|||||11.56|1.13|0.025
71675762|NCT00596817|142869096|SUPERIORITY_OR_OTHER||Difference|12.13||||0.002|TWO_SIDED|95.0|4.73|19.52||A nominal p-value is provided.|Fisher Exact|||||19.52|4.73|0.002
71675763|NCT00596817|142869097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.73||0.3642|TWO_SIDED|95.0|-2.12|0.78||A nominal p-value is provided.|ANCOVA|||||0.78|-2.12|0.3642
71805983|NCT00674986|143112230|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71805984|NCT00674986|143112231|SUPERIORITY_OR_OTHER|||||||0.2777||95.0|||||t-test, 2 sided|||||||0.2777
71805985|NCT00674986|143112232|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||t-test, 2 sided|||||||0.1160
71805986|NCT00674986|143112233|SUPERIORITY_OR_OTHER|||||||0.1146||95.0|||||t-test, 2 sided|||||||0.1146
71675764|NCT01515865|142869138|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8||||0.3145|TWO_SIDED|95.0|-37.6|9.8|||Fisher Exact|||||9.8|-37.6|0.3145
71805987|NCT00674986|143112234|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.0470
71805988|NCT00674986|143112235|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||t-test, 2 sided|||||||0.0003
71805989|NCT01997398|143112237|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Differences in baseline and 6-month postoperative scores were assessed using a series of repeated measures general linear models with a single within-subjects factor and no between-subjects factors.|Repeated measures general linear models|||||||<0.001
71805990|NCT04389762|143112290|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71805991|NCT04389762|143112291|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
71805992|NCT04389762|143112292|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
71805993|NCT04389762|143112293|OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.040
71805994|NCT04389762|143112294|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71805995|NCT04389762|143112295|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
71805996|NCT04389762|143112296|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71805997|NCT03822533|143112298|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.69|TWO_SIDED|95.0|-0.059|0.089|||t-test, 2 sided|||Mean difference using independent samples t-test.||0.089|-0.059|0.69
71805998|NCT03822533|143112298|SUPERIORITY||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.093|0.063||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||Presenting β-values from linear regression analysis for group variable adjusted for baseline differences in EQ-5D-3L-index. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||0.063|-0.093|
71805999|NCT03822533|143112299|SUPERIORITY||Mean Difference (Final Values)|-364.0||||0.17|TWO_SIDED|95.0|-891.0|164.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||164|-891|0.17
71806000|NCT03822533|143112299|SUPERIORITY||Mean Difference (Final Values)|-364.0|||||TWO_SIDED|95.0|-870.0|143.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis||||143|-870|
71806001|NCT03822533|143112300|SUPERIORITY||Mean Difference (Final Values)|-233.0||||0.23|TWO_SIDED|95.0|-616.0|150.0|||t-test, 2 sided|||Independent-samples t-test. Dependent variable cost items, independent variable group (physiotherapist or physician assessment)||150|-616|0.23
71806002|NCT03822533|143112300|SUPERIORITY||Mean Difference (Final Values)|-233.0|||||TWO_SIDED|95.0|-605.0|139.0||The linear regression analysis was needed to calculate the incremental cost efficiency ratio (ICER). The p-value from this test was not relevant for the ICER calculation.|Regression, Linear|First step in a cost-efficiency analysis.||Linear regression analysis. The results from this analysis were used to calculate incremental cost-effectiveness ratio (mean difference in costs divided by mean difference in QALYs).||139|-605|
71806003|NCT03822533|143112303|SUPERIORITY||Mean Difference (Final Values)|48.0||||0.72|TWO_SIDED|95.0|-219.0|314.0|||t-test, 2 sided|||||314|-219|0.72
71806004|NCT03822533|143112304|SUPERIORITY||Mean Difference (Final Values)|-178.0|||<|0.01|TWO_SIDED|95.0|-239.0|118.0|||t-test, 2 sided|||||118|-239|<0.01
71806005|NCT03822533|143112305|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.01|TWO_SIDED|95.0|-42.0|6.2|||t-test, 2 sided|||||6.2|-42|0.01
71806006|NCT03822533|143112306|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.62|TWO_SIDED|95.0|-59.0|36.0|||t-test, 2 sided|||||36|-59|0.62
71806007|NCT03822533|143112307|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.87|TWO_SIDED|95.0|-13.0|15.0|||t-test, 2 sided|||||15|-13|0.87
71806008|NCT03822533|143112308|SUPERIORITY||Mean Difference (Final Values)|-254.0||||0.27|TWO_SIDED|95.0|-728.0|220.0|||t-test, 2 sided|||||220|-728|0.27
71806009|NCT03822533|143112309|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.96|TWO_SIDED|95.0|-113.0|118.0|||t-test, 2 sided|||||118|-113|0.96
71806010|NCT02349295|143112324|OTHER||Odds Ratio (OR)|4.74|||<|0.001|TWO_SIDED|95.0|2.65|8.48||model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).|Regression, Logistic|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.||||8.48|2.65|<0.001
71806011|NCT02349295|143112324|OTHER|1\) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|Odds Ratio (OR)|3.79|||<|0.001|TWO_SIDED|95.0|2.12|6.78|||Regression, Logistic|||model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)||6.78|2.12|<0.001
71813586|NCT04858802|143129486|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|2.48||0.868|TWO_SIDED|95.0|-0.7|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 21||0.6|-0.7|0.868
71813587|NCT04858802|143129486|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|2.3||0.823|TWO_SIDED|95.0|-0.5|0.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 45||0.7|-0.5|0.823
71806012|NCT01259713|143112352|NON_INFERIORITY_OR_EQUIVALENCE|For the interim analysis performed when 50% of the subjects had completed the study, an alpha of 0.0003 was spent. Therefore, the significance level for the 2-sided test in the primary analysis at the end of the study was 0.0497 (corresponding to 95.03% confidence interval (CI)).|Relative risk reduction|0.33||||0.24|TWO_SIDED|95.03|-0.32|0.66||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|A two-group Cochran-Mantel-Haenszel (CMH) test with a 0.05 two-sided significance level and 2:1 allocation of 354 randomized subjects (236 AmBisome, 118 placebo) would have 81% power to detect a relative reduction of 75% if the rate of IFI is 10% in the placebo group (based on unpublished data from the German Multicenter Acute Lymphoblastic Leukemia Working Group (GMALL) and consistent with the published rate of 16.4% in patients with hematological malignancies undergoing remission induction).||0.66|-0.32|0.24
71806013|NCT01259713|143112353|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.15|TWO_SIDED|95.0|-0.11|0.5||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.50|-0.11|0.15
71806014|NCT01259713|143112354|SUPERIORITY_OR_OTHER||Relative risk reduction|-0.01||||0.97|TWO_SIDED|95.0|-0.94|0.47||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.47|-0.94|0.97
71806015|NCT01259713|143112355|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||The p-value is from the log-rank test stratified by region.|Log Rank|||||||0.33
71806016|NCT01259713|143112356|SUPERIORITY_OR_OTHER||Relative risk reduction|0.25||||0.22|TWO_SIDED|95.0|-0.19|0.53||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|||0.53|-0.19|0.22
71842361|NCT03663205|143196098|OTHER||Least squares mean difference|-3.2|||||TWO_SIDED|95.0|-7.6|1.2|||||Based on a constrained longitudinal data analysis model with QLQ-LC13 chest pain score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in chest pain score||1.2|-7.6|
71842362|NCT03663205|143196099|OTHER||Least squares mean difference|3.9|||||TWO_SIDED|95.0|-0.9|8.7|||||Based on a constrained longitudinal data analysis model with QLQ-LC30 Global Health Status/Quality of Life score on the response variable and treatment by study visit interaction and randomization stratification factors as covariates.|Least squares mean difference in Global Health Status/Quality of Life score||8.7|-0.9|
71842363|NCT02577354|143196102|SUPERIORITY|||||||0.138||||||The threshold for statistical significance was p=0.05|Wald asymptotic test of proportions|Cui p-value adjustment for sample size re-estimation at interim analysis; Multiple imputation utilized for 3 participants lost to follow-up.||||||0.138
71842364|NCT02577354|143196103|SUPERIORITY|||||||0.032||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.032
71675765|NCT01113385|142869139|SUPERIORITY_OR_OTHER|||||||0.009||||||p value reflects the difference in mean FSPF pre vs post galactose treatment.|t-test, 2 sided|||||||0.009
71842365|NCT02577354|143196104|SUPERIORITY|||||||0.0499||||||The threshold for significance was p=0.05.|Friedman's regression analysis|Multiple Imputation utilized for 3 participants lost to follow-up.||||||0.0499
71842366|NCT02577354|143196106|SUPERIORITY|||||||0.011||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.011
71842367|NCT02577354|143196107|SUPERIORITY|||||||0.009||||||Threshold for statistical significance was p=0.05|t-test, 2 sided|||||||0.009
71842368|NCT02577354|143196108|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was 0.05|t-test, 2 sided|||||||<0.001
71842369|NCT02577354|143196109|SUPERIORITY|||||||0.003||||||Threshold for statistical significance was p=0.05.|Wilcoxon (Mann-Whitney)|||||||0.003
71842370|NCT02577354|143196110|SUPERIORITY|||||||0.335||||||Threshold for statistical significance was p=0.05.|Chi-squared|||||||0.335
71675766|NCT01560234|142869232|SUPERIORITY_OR_OTHER||Slope|0.81|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|0.63|1.0|||Regression, Linear||AUC (nmol\*h/L) 5 to 30 μg|||1.00|0.63|
71675767|NCT01560234|142869233|SUPERIORITY_OR_OTHER||Slope|0.84|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.65|1.04|||Regression, Linear||AUC(0-t) (nmol\*h/L) 5 to 30 μg|||1.04|0.65|
71806017|NCT01259713|143112357|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
71806018|NCT01259713|143112358|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel|||||||0.32
71806019|NCT01259713|143112359|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED|||||The p-value was from the log-rank test stratified by region.|Log Rank|Participants without consolidation/salvage therapy dates were censored using the earlier of the Early Termination and Study Completion dates.||||||0.69
71806020|NCT01259713|143112360|SUPERIORITY_OR_OTHER||Relative risk reduction|0.08||||0.2|TWO_SIDED|95.0|-0.04|0.19||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|Participants were not stratified for leukemia risk.||0.19|-0.04|0.20
71806021|NCT06111742|143112361|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Induction||||<0.001
71806022|NCT06111742|143112361|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||OR entry||||<0.001
71675768|NCT01560234|142869234|SUPERIORITY_OR_OTHER||Slope|0.95|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|90.0|0.87|1.04|||Regression, Linear||Cmax (nmol/L) 0.5 to 30 μg|||1.04|0.87|
71675769|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|99.75|||||TWO_SIDED|95.0|65.76|151.32|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Plasma||151.32|65.76|
71675770|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|92.99|||||TWO_SIDED|95.0|61.21|141.27|||ANCOVA||Cohort 2/1.5ug vs Placebo|24 hour Plasma||141.27|61.21|
71675771|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|145.83|||||TWO_SIDED|95.0|96.11|221.28|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Plasma||221.28|96.11|
71675772|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|106.23|||||TWO_SIDED|95.0|66.42|169.93|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Plasma||169.93|66.42|
71675773|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|223.76||||||95.0|144.98|345.35|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour plasma||345.35|144.98|
71806023|NCT06111742|143112362|SUPERIORITY|||||||0.022|||||||t-test, 2 sided|||||||0.022
71806024|NCT06111742|143112364|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71806025|NCT00958919|143112397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.0004|TWO_SIDED|95.0|2.69|9.38|||t-test, 2 sided|||||9.38|2.69|.0004
71806026|NCT00958919|143112398|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.024|TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||||6.85|0.49|.024
71806027|NCT00958919|143112399|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
71675774|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|228.23|||||TWO_SIDED|95.0|150.36|346.41|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour plasma||346.41|150.36|
71675775|NCT01560234|142869235|SUPERIORITY_OR_OTHER||Percentage of Placebo|684.03|||||TWO_SIDED|95.0|495.31|944.65|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour plasma||944.65|495.31|
71675776|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|95.81|||||TWO_SIDED|95.0|72.7|126.28|||ANCOVA||Cohort 1/0.15 ug vs Placebo|48 hour plasma||126.28|72.70|
71675777|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|91.72|||||TWO_SIDED|95.0|69.53|121.0|||ANCOVA||Cohort 2/0.5 ug vs Placebo|48 hour plasma||121.00|69.53|
71806028|NCT00958919|143112400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71842371|NCT02577354|143196118|SUPERIORITY|||||||0.048||||||The threshold for statistical significance was p=0.05.|Wald asymptotic test of proportions|Multiple imputation used for three participants lost to follow-up.||||||0.048
71675778|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|112.34|||||TWO_SIDED|95.0|82.3|153.35|||ANCOVA||Cohort 3/1.5 ug vs Placebo|48 hour Plasma||153.35|82.30|
71675779|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|120.0|||||TWO_SIDED|95.0|91.04|158.18|||ANCOVA||Cohort 4/5 ug vs Placebo|48 hour plasma||158.18|91.04|
71675780|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|102.67|||||TWO_SIDED|95.0|77.02|136.87|||ANCOVA||Cohort 5/15 ug vs Placebo|48 hour placebo||136.87|77.02|
71675781|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|146.86|||||TWO_SIDED|95.0|111.39|193.62|||ANCOVA||Cohort 7/15 ug vs Placebo|48 hour plasma||193.62|111.39|
71675782|NCT01560234|142869236|SUPERIORITY_OR_OTHER||Percentage of Placebo|240.04|||||TWO_SIDED|95.0|193.82|297.28|||ANCOVA||Cohort 6 and 8/30 ug|48 hour plasma||297.28|193.82|
71675783|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|114.87|||||TWO_SIDED|95.0|34.83|378.78|||ANCOVA||Cohort 1/0.15 ug vs Placebo|24 hour Sputum||378.78|34.83|
71675784|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.89|||||TWO_SIDED|95.0|24.96|268.7|||ANCOVA||Cohort 2/0.5 ug vs Placebo|24 hour Sputum||268.70|24.96|
71806029|NCT00958919|143112401|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71806030|NCT01552213|143112402|SUPERIORITY||Risk Ratio (RR)|0.8||||0.32|TWO_SIDED|95.0|0.53|1.24|||Chi-squared|||||1.24|0.53|0.32
71806031|NCT01552213|143112403|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
71806032|NCT01552213|143112404|SUPERIORITY|||||||0.96|||||||Chi-squared|||||||0.96
71806033|NCT01552213|143112405|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71806034|NCT01552213|143112406|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
71806035|NCT01552213|143112407|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71806036|NCT01552213|143112408|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71806037|NCT01552213|143112409|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
71806038|NCT01552213|143112410|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71806039|NCT01552213|143112411|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||||||0.42
71806040|NCT01552213|143112412|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
71806041|NCT01552213|143112413|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71806042|NCT01552213|143112414|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71806043|NCT01552213|143112415|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||0.56
71806044|NCT04723576|143112421|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|0.189||||0.77|TWO_SIDED|95.0|-1.068|1.446|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||1.446|-1.068|.77
71806045|NCT04723576|143112422|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.238||||0.39|TWO_SIDED|95.0|-0.31|0.785|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.785|-0.310|.39
71806046|NCT04723576|143112423|OTHER|Standard 2-sided non-equivalence test|Mean Difference (Net)|-0.232||||0.24|TWO_SIDED|95.0|-0.618|0.153|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.153|-0.618|.24
71806047|NCT04723576|143112424|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.134||||0.23|TWO_SIDED|95.0|-0.085|0.352|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.352|-0.085|.23
71806048|NCT04723576|143112425|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|-0.051||||0.44|TWO_SIDED|95.0|-0.179|0.078|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.44
71806049|NCT04723576|143112426|OTHER|Standard 2-sided non-equivalence test|Odds Ratio, log|-0.051||||0.85|TWO_SIDED|95.0|-0.179|0.078|||Repeated measure logistic regression|using GEE method|Effect sizes are the difference between SFA minus Usual Care.|||0.078|-0.179|.85
71842372|NCT02577354|143196119|SUPERIORITY||||||<|0.001||||||"P-value for Satisfied with Treatment. Threshold for statistical significance was p=0.05"|Cochran-Mantel-Haenszel|||||||<0.001
71675785|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|81.55|||||TWO_SIDED|95.0|20.63|322.42|||ANCOVA||Cohort 3/1.5 ug vs Placebo|24 hour Sputum||322.42|20.63|
71675786|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|304.37|||||TWO_SIDED|95.0|76.61|1209.33|||ANCOVA||Cohort 4/5 ug vs Placebo|24 hour Sputum||1209.33|76.61|
71675787|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|193.8|||||TWO_SIDED|95.0|59.01|636.49|||ANCOVA||Cohort 5/15 μg vs Placebo|24 hour Sputum||636.49|59.01|
71675788|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|467.96|||||TWO_SIDED|95.0|142.77|1533.92|||ANCOVA||Cohort 7/15 μg vs Placebo|24 hour Sputum||1533.92|142.77|
71806050|NCT04723576|143112427|OTHER|Standard 2-sided non-equivalence test|Median Difference (Net)|0.23||||0.08|TWO_SIDED|95.0|-0.025|0.484|||Mixed Models Analysis||Effect sizes are the difference between SFA minus Usual Care|||0.484|-0.025|.08
71806051|NCT02119416|143112491|OTHER|Maximum heart rate after 2 mg/kg of caffeine compared to baseline was assessed using a mixed effects regression model. Sex and pubertal stage were included in the model as time invariant predictors.|||||<|0.05||||||The p-value was not adjusted for multiple comparisons.|mixed effects regression|||||||<0.05
71806052|NCT02119416|143112491|OTHER|We compared means of our dependent variables after administration of different doses of caffeine.|||||<|0.05||||||The p-value was set prior to the analysis and all comparisons were planned.|ANCOVA|||We used repeated measures ANOVAS and conducted planned comparisons between groups as post-hoc tests.||||< 0.05
71806053|NCT02119416|143112492|OTHER|mixed effects regression models were used with sex and pubertal stage as time invariant predictors.|||||<|0.05|||||||mixed effects regression|||order was included in the analysis. We examined caffeine dose.||||<0.05
71675789|NCT01560234|142869238|SUPERIORITY_OR_OTHER||Comparison of Placebo|1087.35|||||TWO_SIDED|95.0|317.19|3727.57|||ANCOVA||Cohort 6 and 8/30 μg vs Placebo|24 hour Sputum||3727.57|317.19|
71675790|NCT02088905|142869274|SUPERIORITY|||||||0.08||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.080
71675791|NCT02088905|142869274|SUPERIORITY|||||||0.026||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.026
71675792|NCT02088905|142869274|OTHER|Type III Tests of Fixed Effects|||||<|0.001||||||Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||<.001
71806054|NCT02119416|143112492|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71894423|NCT01193335|143310974|SUPERIORITY_OR_OTHER||GMFR ratio|1.15|||||TWO_SIDED|95.0|0.88|1.52||||||Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 - Group 2).||1.52|0.88|
71675793|NCT02088905|142869274|OTHER|Type III Tests of Fixed Effects||||||0.182||||||Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.182
71675794|NCT02088905|142869274|OTHER|Type III Tests of Fixed Effects||||||0.015||||||Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint\*Treatment Assignment interaction. Random intercept used.||||.015
71675795|NCT02088905|142869275|SUPERIORITY|||||||0.203||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority||||.203
71675796|NCT02088905|142869275|SUPERIORITY|||||||0.17||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.17
71675797|NCT02088905|142869275|SUPERIORITY|||||||0.308||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.308
71806055|NCT03593655|143112508|SUPERIORITY||incidence rate ratio|1.01||||0.92|TWO_SIDED|95.0|0.9|1.12||the a priori threshold for statistical significance was \<0.05|generalized estimating equation|Poisson (log) link, adjusted for period, offset of number of visits per period, exchangeable correlation structure, and robust errors.|The incidence rate ratio compares FTC/TDF to the dapivirine vaginal ring.|Comparison of the proportion of participants experiencing a grade 2 adverse event between products, with a null hypothesis of no difference.||1.12|0.90|0.92
71806056|NCT03732209|143112514|SUPERIORITY||F value, group x time interaction|7.155||||0.017|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||Reported values in outcome measures data table reflect mean change in glycosylated hemoglobin for each group (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.017
71806057|NCT03732209|143112515|SUPERIORITY||F value, group x time interaction|4.885||||0.042|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA||The values reported in the outcome measures data table reflect mean change in AUC (Session 2 - Session 1)|Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.||||.042
71806058|NCT03732209|143112516|SUPERIORITY||F value, group x time interaction|2.33||||0.146|TWO_SIDED|||||This p value reflects the interaction between group (episodic future thinking, control) and time (baseline, Week 8)|ANOVA|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.146
71806059|NCT03732209|143112517|SUPERIORITY||Median Difference (Final Values)|1.23||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.||||.042
71675798|NCT02088905|142869275|SUPERIORITY|||||||0.413||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.413
71675799|NCT02088905|142869277|SUPERIORITY|||||||0.271||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||0.271
71675800|NCT02088905|142869277|SUPERIORITY|||||||0.434||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.434
71675801|NCT02088905|142869277|SUPERIORITY|||||||0.298||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority||||.298
71675802|NCT02088905|142869277|SUPERIORITY|||||||0.294||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.294
71806060|NCT05046795|143112518|SUPERIORITY||Mean Difference (Net)|150.91|STANDARD_ERROR_OF_MEAN|23.727|<|0.0001|TWO_SIDED|95.0|104.145|197.671|||Mixed Models Analysis|||||197.671|104.145|<0.0001
71675803|NCT02088905|142869277|SUPERIORITY|||||||0.441||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority||||.441
71806061|NCT05046795|143112519|SUPERIORITY||Mean Difference (Net)|144.35|STANDARD_ERROR_OF_MEAN|21.192|<|0.0001|TWO_SIDED|95.0|102.61|186.088|||Mixed Models Analysis|||||186.088|102.610|<0.0001
71806062|NCT05046795|143112520|SUPERIORITY||Mean Difference (Net)|287.75|STANDARD_ERROR_OF_MEAN|38.473|<|0.0001|TWO_SIDED|95.0|211.933|363.57|||Mixed Models Analysis|||||363.570|211.933|<0.0001
71806063|NCT05046795|143112521|SUPERIORITY||Mean Difference (Net)|105.9|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|72.6|139.12|||ANCOVA|||||139.12|72.60|<0.0001
71806064|NCT05046795|143112522|SUPERIORITY||Mean Difference (Net)|154.8|STANDARD_ERROR_OF_MEAN|28.37|<|0.0001|TWO_SIDED|95.0|98.86|210.78|||ANCOVA|||||210.78|98.86|<0.0001
71675804|NCT02088905|142869277|SUPERIORITY|||||||0.204||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority||||.204
71675805|NCT02088905|142869279|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority||||<.001
71675806|NCT02088905|142869279|SUPERIORITY||||||<|0.001||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.||||<.001
71675807|NCT04606394|142869324|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.33|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.33
71675808|NCT04606394|142869325|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.04|TWO_SIDED||||||Chi-squared|||Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.||||0.04
71675809|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|Geometric Mean Titer (GMT) Ratio|0.69|||||TWO_SIDED|95.0|0.46|1.04|||||Analysis of variance (ANOVA) model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.04|0.46|
71675810|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.91|||||TWO_SIDED|95.0|0.6|1.38|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.38|0.60|
71675811|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.63|||||TWO_SIDED|95.0|0.41|0.96|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||0.96|0.41|
71806065|NCT05046795|143112523|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|1.8||0.0064|TWO_SIDED|95.0|-8.49|-1.4|||ANCOVA|||||-1.40|-8.49|0.0064
71806066|NCT05046795|143112524|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0144|TWO_SIDED|95.0|1.16|3.84|||Regression, Logistic|||||3.84|1.16|0.0144
71806067|NCT01715805|143112554|SUPERIORITY||Least Squares Mean Difference (LSMD)|-0.2||||0.7948|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine + ADT - Placebo + ADT|||1.2|-1.6|0.7948
71806068|NCT01715805|143112555|SUPERIORITY||LSMD|-0.7||||0.2784|TWO_SIDED|95.0|-1.9|0.5||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine +ADT - Placebo + ADT|||0.5|-1.9|0.2784
71806069|NCT02890381|143112566|OTHER||% vaccine recipients with solicited AEs|64.0|||||TWO_SIDED|90.0|35.0|86.0||||||||86|35|
71806070|NCT02890381|143112566|OTHER||% placebo recipients with solicited AEs|100.0|||||TWO_SIDED|90.0|61.0|100.0||||||||100|61|
71806071|NCT02890381|143112567|OTHER||% vaccinees with unsolicited AEs|36.0|||||TWO_SIDED|90.0|14.0|65.0||||||||65|14|
71806072|NCT02890381|143112567|OTHER||% placebo with unsolicited AEs|50.0|||||TWO_SIDED|90.0|15.0|85.0||||||||85|15|
71806073|NCT02890381|143112572|SUPERIORITY|||||||0.64||||||Since the sample sizes are unequal, at the suggestion of the DSMB statistician, a 1-sided Fisher's exact test was used to test the hypothesis that the proportions of \>=4-fold rises were higher in the vaccinated group than in the placebo group.|Fisher Exact|||||||0.64
71806074|NCT02890381|143112573|SUPERIORITY|||||||0.73||||||The threshold for statistical significance is 0.05.|Log Rank|||||||0.73
71806075|NCT01201629|143112578|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71806076|NCT01201629|143112579|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71806077|NCT00395876|143112636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6||||0.0002||95.0|18.4|54.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||54.8|18.4|0.0002
71806078|NCT00395876|143112637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4||||0.1385||95.0|-3.1|25.8||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||25.8|-3.1|0.1385
71806079|NCT00395876|143112638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.9||||0.0093||95.0|7.1|42.6||Stratified by baseline weight (\< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel|||||42.6|7.1|0.0093
71806080|NCT01359735|143112674|SUPERIORITY_OR_OTHER|||||||0.263|TWO_SIDED|||||Week 04|Wilcoxon (Mann-Whitney)|||||||0.263
71806081|NCT01359735|143112674|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Week 13|Wilcoxon (Mann-Whitney)|||||||0.500
71806082|NCT01359735|143112675|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Over weeks 1 through 4 or Week 4?|Fisher Exact|||||||0.5
71806083|NCT01359735|143112676|SUPERIORITY_OR_OTHER|||||||0.0594|TWO_SIDED||||||Log Rank|||||||0.0594
71806084|NCT01359735|143112677|SUPERIORITY_OR_OTHER|||||||0.1354|ONE_SIDED|||||3 Weeks|t-test, 1 sided|||||||0.1354
71806085|NCT01359735|143112677|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||12 Weeks|t-test, 1 sided|||||||0.5000
71842373|NCT02577354|143196121|SUPERIORITY||||||<|0.001||||||Threshold for statistical significance was p=0.05.|Cochran-Mantel-Haenszel|||||||<0.001
71842374|NCT03995979|143196138|SUPERIORITY|||||||0.05||||||The P-value was calculated using a paired t test|Paired t-test|||A compositional analysis with species-level alpha diversity will be performed between the three conditions (Pre-Dietary Restriction, Dietary Restriction, and Post-Dietary Restriction,) with ANOVA testing. Furthermore, a differential abundance analysis will be performed to further identify and confirm prevalent organisms associated with the experimental dietary restriction.||||0.05
71842375|NCT04109066|143196140|SUPERIORITY||Odds Ratio (OR)|2.05||||0.0021|TWO_SIDED|95.0|1.29|3.27|||Cochran-Mantel-Haenszel||"Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.~Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method."|Arm A over Arm B||3.27|1.29|0.0021
71842376|NCT04109066|143196140|OTHER||Adjusted Difference of pCR Rates|10.5|||||TWO_SIDED|95.0|4.0|16.9|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by PD-L1 by SP142 (\< 1% vs. \>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||16.9|4.0|
71806086|NCT01359735|143112678|SUPERIORITY_OR_OTHER|||||||0.0841|TWO_SIDED|||||Week 3 Post-surgery|t-test, 1 sided|||||||0.0841
71806087|NCT01359735|143112678|SUPERIORITY_OR_OTHER|||||||0.178|TWO_SIDED|||||Week 12 Post-surgery|t-test, 1 sided|||||||0.1780
71806088|NCT00156065|143112770|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8619||||||95.0|0.6912|0.9644|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9644|0.6912|
71806089|NCT00156065|143112770|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.8834||||||95.0|0.7744|0.955|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9550|0.7744|
71806090|NCT00156065|143112770|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Estimate of Loss of Effect|0.9376||||||95.0|0.7631|0.9952|||||Loss of effect = increase in total PANSS \>=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score \>=6; discontinuation for lack of efficacy.|||0.9952|0.7631|
71806091|NCT04745169|143112772|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71806092|NCT04745169|143112773|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71806093|NCT04745169|143112774|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71806094|NCT04745169|143112775|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71806095|NCT04745169|143112776|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||0.55
71806096|NCT04745169|143112777|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71806097|NCT04745169|143112778|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71806098|NCT04745169|143112779|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71806099|NCT04745169|143112780|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71806100|NCT00920426|143112781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||<|0.001|TWO_SIDED|95.0|-2.547|-1.632||Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.632|-2.547|<0.001
71806101|NCT00920426|143112807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.804|||<|0.001|TWO_SIDED|95.0|-2.173|-1.436||ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.|ANCOVA|||||-1.436|-2.173|<0.001
71806102|NCT00920426|143112808|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71806103|NCT01292603|143112819|NON_INFERIORITY_OR_EQUIVALENCE|A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.|Adjusted geometric mean ratio|1.533|||||TWO_SIDED|90.0|1.269|1.852|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.852|1.269|
71806104|NCT01292603|143112820|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.979|1.242|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.242|0.979|
71806105|NCT01292603|143112821|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.719|||||TWO_SIDED|90.0|0.653|0.792|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||0.792|0.653|
71806106|NCT01292603|143112822|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|14.884|||||TWO_SIDED|90.0|11.215|19.755|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||19.755|11.215|
71806107|NCT01292603|143112823|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.895|1.139|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.|||1.139|0.895|
71842377|NCT04109066|143196141|SUPERIORITY||Odds Ratio (OR)|3.11|||||TWO_SIDED|95.0|1.58|6.11|||||Stratified by AC Dose-Frequency. Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.|Arm A over Arm B||6.11|1.58|
71842378|NCT04109066|143196141|OTHER||Adjusted Difference of pCR Rates|24.1|||||TWO_SIDED|95.0|10.7|37.5|||||"Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.~Stratified by AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT."|||37.5|10.7|
71842379|NCT05652010|143196147|OTHER|Comparative study|Odds Ratio (OR)|0.576||||0.164|TWO_SIDED|95.0|0.2634|1.2659||P=0.164 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model. As it was an exploratory study no adjustment for multiple comparison was performed.|P=0.164 for testing the hypothesis that OR=1|||1.2659|0.2634|0.164
71842380|NCT05652010|143196148|OTHER||Binominal|0.9|||<|0.0001|TWO_SIDED|95.0|0.75|0.97|||Exact test in the binomial distribution|Exact test in the binomial distribution tested if the proportion of very satisfied/satisfied was sign. different from 50% when using a 5% test level|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|||0.97|0.75|<0.0001
71842381|NCT05652010|143196149|OTHER|The binomial proportion is based on subjects that have answered the questions. Exact test in the binomial distribution.|Binominal|0.82|||<|0.0001|TWO_SIDED|95.0|0.66|0.92|||Exact test in the binominal distribution|Exact test in the binomial distribution tested if the proportion of YES was significantly different from 50% when using a 5% test level||||0.92|0.66|<0.0001
71842382|NCT05652010|143196150|OTHER||Odds Ratio (OR)|0.259||||0.027|TWO_SIDED|95.0|0.078|0.855||P=0.027 for testing the hypothesis that OR=1|Mixed Models Analysis|Generalized linear mixed model|P=0.027 for testing the hypothesis that OR=1|||0.855|0.078|0.027
71842383|NCT02510235|143196183|NON_INFERIORITY|"To declare non-inferiority between treatments, a change in the SANDE overall score of 12 mm was required, with an estimated standard deviation of 13 (approximately 70% of the mean at 28 ± 4 days after treatment).~The left inferior limits of confidence interval were determined and compared with the non-inferiority limit defined in the testing hypothesis.~Testing Hypothesis:~H0: meanHyaluronic - meanLubricin ≤ - 12~/ H1: meanHyaluronic - meanLubricin \> - 12"|Mean Difference (Final Values)|1.5|||||ONE_SIDED|95.0|-8.87||||Student t-test for unpaired data.|||Values at Day 28 ± 4 (end of treatment) for the SANDE overall VAS score were compared between treatment groups using a Student's t-test for unpaired data.|||-8.87|
71842384|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.8226|TWO_SIDED|95.0|-7.66|6.11|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score||Foreign Body Sensation in the Study Eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||6.11|-7.66|0.8226
71842385|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.3178|TWO_SIDED|95.0|-3.13|9.44|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Burning/Stinging in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||9.44|-3.13|0.3178
71842386|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|6.52||||0.0085|TWO_SIDED|95.0|1.74|11.3|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Itching in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||11.30|1.74|0.0085
71806108|NCT01808690|143112851|SUPERIORITY|||||||0.005||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted multivariable models, which included sex, pubertal status, change in BMI, and baseline M/I.||Insulin function was defined as M/I (mg/kg/min)/(insulin). Power calculations were based on data from a small study in youth with poorly controlled T1DM, which reported a significant increase in M/I in the 11 participants treated with Metformin. On the basis of the effect size reported in that study, a sample size of 25 per group and an alpha of 0.05 provided us with 93% power to detect a difference of 1 SD in the primary outcome of M/I.||||0.005
71806109|NCT01808690|143112852|SUPERIORITY|||||||0.46||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of the variable, sex, age, change in VO2peak, change in insulin sensitivity, and treatment condition.||||||0.46
71806110|NCT01808690|143112853|SUPERIORITY|||||||0.04||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.04
71842387|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|3.41||||0.3124|TWO_SIDED|95.0|-3.31|10.13|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Pain in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.13|-3.31|0.3124
71894424|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71806111|NCT01808690|143112854|SUPERIORITY|||||||0.04||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.04
71806112|NCT01808690|143112855|SUPERIORITY|||||||0.01||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of BMI percentile, diabetes duration, and A1c.||||||0.01
71806113|NCT01808690|143112856|SUPERIORITY|||||||0.03||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.||||||0.03
71842388|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|6.76||||0.0377|TWO_SIDED|95.0|0.4|13.12|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Sticky feeling in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||13.12|0.40|0.0377
71842389|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.5321|TWO_SIDED|95.0|-4.62|8.83|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Blurred vision in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||8.83|-4.62|0.5321
71842390|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|2.32||||0.579|TWO_SIDED|95.0|-6.04|10.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Photophobia in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||10.68|-6.04|0.5790
71842391|NCT02510235|143196185|SUPERIORITY||Mean Difference (Final Values)|16.13||||0.3383|TWO_SIDED|95.0|-17.41|49.68|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Total ocular tolerability score in Study eye was analyzed using a repeated measures ANOVA, which evaluates changes from baseline across all time points in a single analysis. This method provides one overall value for comparison, as it incorporates all time points into a unified analysis. Consequently, the reported value represents the global outcome across time points, consistent with the repeated measures ANOVA methodology.||49.68|-17.41|0.3383
71842392|NCT02510235|143196186|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.6484|TWO_SIDED|95.0|-5.07|3.19|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||3.19|-5.07|0.6484
71842393|NCT02510235|143196187|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7408|TWO_SIDED|95.0|-0.71|0.51|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.51|-0.71|0.7408
71842394|NCT02510235|143196188|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.8596|TWO_SIDED|95.0|-0.78|0.87|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study Eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.87|-0.78|0.8596
71842395|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.7891|TWO_SIDED|95.0|-0.16|0.2|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Meibomian glands in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.20|-0.16|0.7891
71842396|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6075|TWO_SIDED|95.0|-0.24|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Erythema in Study eye analytic statistic is presented. The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.24|0.6075
71842397|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.6639|TWO_SIDED|95.0|-0.14|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Eyelid - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.14|0.6639
71842398|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3482|TWO_SIDED|95.0|-0.1|0.29|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Erythema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value is not duplicated or triplicated, reflecting the global outcome consistent with repeated measures ANOVA methodology.||0.29|-0.10|0.3482
71894425|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|-2.33|||||TWO_SIDED|95.0|-8.15|1.96||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||1.96|-8.15|
71842399|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.2422|TWO_SIDED|95.0|-0.34|0.09|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Conjunctiva - Oedema in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.09|-0.34|0.2422
71842400|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8645|TWO_SIDED|95.0|-0.11|0.14|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Lens in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.14|-0.11|0.8645
71842401|NCT02510235|143196189|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.379|TWO_SIDED|95.0|-0.11|0.04|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Cornea transparency in Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.04|-0.11|0.3790
71842402|NCT02510235|143196190|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8363|TWO_SIDED|95.0|-0.26|0.21|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.21|-0.26|0.8363
71842403|NCT02510235|143196191|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.6248|TWO_SIDED|95.0|-0.62|1.02|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||1.02|-0.62|0.6248
71842404|NCT02510235|143196192|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.6153|TWO_SIDED|95.0|-0.82|0.49|||ANOVA|The analysis of variance included as sources of variability treatment, site and baseline tolerability score.||Study eye analytic statistic is presented.The Statistical Analysis section reports results from a repeated measures ANOVA, which analyzes changes from baseline (Visit 2 - Day 1) across all time points in a single unified analysis. This approach provides one overall comparison value by incorporating all time points. Consequently, the reported value represents the global outcome, consistently with repeated measures ANOVA methodology.||0.49|-0.82|0.6153
71842405|NCT03367156|143196193|OTHER||Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.8|0.7|||Linear Model|||||0.7|-0.8|0.48
71675812|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.98|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.71|0.98|
71842406|NCT03367156|143196194|OTHER||Mean Difference (Final Values)|0.2|||>|0.99|TWO_SIDED|95.0|-0.7|1.0|||Linear Model|||||1|-0.7|>0.99
71842407|NCT03367156|143196195|OTHER||Mean Difference (Final Values)|0.4||||0.97|TWO_SIDED|95.0|-0.7|1.6|||Linear Model|||||1.6|-0.7|0.97
71842408|NCT03367156|143196196|OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.8|1.0|||Linear Model|||||1.0|-0.8|0.78
71842409|NCT03367156|143196197|OTHER||Mean Difference (Final Values)|-0.5||||0.93|TWO_SIDED|95.0|-10.6|9.6|||Linear Model|||||9.6|-10.6|0.93
71842410|NCT03367156|143196198|OTHER||Mean Difference (Final Values)|0.6||||0.93|TWO_SIDED|95.0|-0.6|1.8|||Linear Model|||||1.8|-0.6|0.93
71842411|NCT03367156|143196199|OTHER||Mean Difference (Final Values)|0.1||||0.82|TWO_SIDED|95.0|-0.9|1.1|||Linear Model|||||1.1|-0.9|0.82
71842412|NCT03367156|143196200|OTHER||Mean Difference (Final Values)|-5.5||||0.38|TWO_SIDED|95.0|-17.9|6.9|||Linear Model|||||6.9|-17.9|0.38
71842413|NCT04881461|143196283|SUPERIORITY||Mean Difference (Final Values)|1.88||||0.0036|TWO_SIDED|95.0|0.6|3.17||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 86% power for the primary endpoint using the primary (trial product) estimand."||3.17|0.60|0.0036
71842414|NCT04881461|143196284|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.1111|TWO_SIDED|95.0|-0.04|0.39||Adjusted P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction.|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The endpoint analysis was based on a 5% significance level. The trial was designed to have 95% power for this key secondary endpoint using the primary (trial product) estimand."||0.39|-0.04|0.1111
71894426|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71675813|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.67|||||TWO_SIDED|95.0|0.51|0.88|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.88|0.51|
71806114|NCT01808690|143112857|SUPERIORITY|||||||0.8||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.||||||0.8
71806115|NCT03586648|143112878|SUPERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than 32 points.|Least-square Mean|39.3|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|32.7|45.9|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||Data only from the first period will be used if period effect is significant.||45.9|32.7|
71806116|NCT03586648|143112879|NON_INFERIORITY|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than -5 points.|Least-square Mean Difference|-11.5|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-19.7|-3.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control.|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.||-3.3|-19.7|
71806117|NCT02041195|143112881|OTHER||Least Squares (LS) Mean Difference|-4.26||||0.004|TWO_SIDED|90.0|-6.81|-1.72||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.72|-6.81|0.004
71806118|NCT02041195|143112881|OTHER||LS Mean difference|-3.63||||0.012|TWO_SIDED|90.0|-6.23|-1.03|||Longitudinal mixed analysis of variance|One-sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.03|-6.23|0.012
71806119|NCT02041195|143112883|OTHER||LS Mean Difference|-3.57|||<|0.001|TWO_SIDED|90.0|-5.24|-1.89||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.89|-5.24|<0.001
71806120|NCT02041195|143112885|OTHER||LS Mean Difference|-2.22||||0.002|TWO_SIDED|90.0|-3.44|-1.0|||Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, timepoint, treatment-by-timepoint, baseline weight as covariate, and participant as random effect was used.|||-1.00|-3.44|0.002
71806121|NCT01461668|143112898|SUPERIORITY||Odds Ratio (OR)|0.41||||0.32|TWO_SIDED|95.0|0.08|1.86|||Fisher Exact||Confidence interval for the odds ratio is based upon the inversion Fisher's exact test|||1.86|0.08|0.320
71806122|NCT01024569|143112904|SUPERIORITY||MIXREG Estimate|-1.16|STANDARD_ERROR_OF_MEAN|-2.21||0.027|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.027
71806123|NCT01024569|143112905|SUPERIORITY||MIXREG Estimate|0.4|STANDARD_ERROR_OF_MEAN|2.37||0.02|TWO_SIDED||||||Mixed Effects Random Regression|||Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.||||0.020
71894427|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71806124|NCT01024569|143112906|SUPERIORITY||MIXREG Estimate|0.05|STANDARD_ERROR_OF_MEAN|0.02||0.029|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.029
71806125|NCT01024569|143112907|SUPERIORITY||MIXREG Estimate|1.06|STANDARD_ERROR_OF_MEAN|0.52||0.042|TWO_SIDED||||||Mixed Effects Random Regression|||||||0.042
71806126|NCT01024569|143112908|SUPERIORITY||MIXREG Estimate|0.39|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED||||||Mixed Effects Random Regression|||||||.001
71806127|NCT01983293|143112917|SUPERIORITY|||||||0.001|ONE_SIDED|95.0|||||Fisher Exact|||||||0.001
71806128|NCT00778648|143112947|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||||||0.023
71806129|NCT03750552|143112953|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.413||0.574|TWO_SIDED|95.0|-1.05|0.58|||Mixed Model Repeated Measures|||||0.58|-1.05|0.574
71806130|NCT03750552|143112954|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.284||0.331|TWO_SIDED|95.0|-0.84|0.28|||Mixed Model Repeated Measures|||||0.28|-0.84|0.331
71806131|NCT03750552|143112955|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.376||0.481|TWO_SIDED|95.0|-1.01|0.48|||Mixed Model Repeated Measures|||||0.48|-1.01|0.481
71806132|NCT03750552|143112956|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.073||0.74|TWO_SIDED|95.0|-0.12|0.17|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.17|-0.12|0.740
71806133|NCT03750552|143112957|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.064||0.0903|TWO_SIDED|95.0|-0.02|0.24|||Cochran-Mantel-Haenszel|Stratified by disease type|The assumed common risk difference estimate and standard error are calculated using Mantel-Haenszel stratum weights and the Sato variance estimator. Mantel-Haenszel confidence limits are shown.|||0.24|-0.02|0.0903
71806134|NCT02212028|143112965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.0||||0.022|TWO_SIDED|95.0|10.0|126.0|||ANOVA|||||126|10|0.022
71806135|NCT02212028|143112966|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||||||0.005
71806136|NCT00626522|143112967|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.131|0.28|||ANCOVA|||||0.280|0.131|<0.0001
71806137|NCT00626522|143112967|SUPERIORITY_OR_OTHER||Least squares mean difference|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.18|0.329|||ANCOVA|||||0.329|0.180|<0.0001
71806138|NCT00626522|143112967|SUPERIORITY_OR_OTHER||Least squares mean difference|0.265|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.191|0.34|||ANCOVA|||||0.340|0.191|<0.0001
71806139|NCT00581230|143112979|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Wilcoxon signed rank test|||||||0.0003
71806140|NCT00581230|143112980|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|||||||0.0001
71894428|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|1.15|||||TWO_SIDED|95.0|-3.13|6.24||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||6.24|-3.13|
71894429|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71675814|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.86|||||TWO_SIDED|95.0|0.65|1.15|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.15|0.65|
71675815|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.27|||||TWO_SIDED|95.0|0.91|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.78|0.91|
71675816|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.68|1.33|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.33|0.68|
71675817|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.22|||||TWO_SIDED|95.0|0.87|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.87|
71675818|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.82|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||0.82|0.46|
71675819|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.62|||||TWO_SIDED|95.0|1.22|2.17|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.17|1.22|
71675820|NCT03423173|142869327|EQUIVALENCE|Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.75|1.35|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.35|0.75|
71675821|NCT03423173|142869328|OTHER||Seropositivity Rates Difference|0.6|||||TWO_SIDED|95.0|-4.99|6.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||6.06|-4.99|
71675822|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-1.65|||||TWO_SIDED|95.0|-6.9|3.19|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||3.19|-6.90|
71806141|NCT01944631|143113010|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.613|STANDARD_ERROR_OF_MEAN|0.359||0.0895|TWO_SIDED|95.0|-1.321|0.095|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.095|-1.321|0.0895
71675823|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-2.25|||||TWO_SIDED|95.0|-7.45|2.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 120||2.69|-7.45|
71675824|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|7.87|||||TWO_SIDED|95.0|0.64|15.3|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||15.30|0.64|
71675825|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|1.5|||||TWO_SIDED|95.0|-4.67|7.65|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||7.65|-4.67|
71675826|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-6.37|||||TWO_SIDED|95.0|-14.0|1.04|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-1 at Day 270||1.04|-14.00|
71675827|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|0.72|||||TWO_SIDED|95.0|-3.87|5.29|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||5.29|-3.87|
71675828|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-0.83|||||TWO_SIDED|95.0|-5.24|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||3.17|-5.24|
71806142|NCT01944631|143113011|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.176|STANDARD_ERROR_OF_MEAN|0.146||0.231|TWO_SIDED|95.0|-0.464|0.113|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.113|-0.464|0.2310
71806143|NCT01944631|143113012|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.443|STANDARD_ERROR_OF_MEAN|0.304||0.1465|TWO_SIDED|95.0|-1.042|0.156|||ANCOVA||Difference calculated as bisolviral minus placebo|||0.156|-1.042|0.1465
71806144|NCT01944631|143113013|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.728|STANDARD_ERROR_OF_MEAN|3.102||0.8148|TWO_SIDED|95.0|-5.39|6.845|||ANCOVA||Difference calculated as bisolviral minus placebo|||6.845|-5.390|0.8148
71806145|NCT01944631|143113014|SUPERIORITY_OR_OTHER|||||||0.1887|TWO_SIDED||||||Log Rank|Log-rank test stratifying for the variable 'baseline TSS'||||||0.1887
71806146|NCT01944631|143113015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1069||||0.6954|TWO_SIDED|95.0|0.666|1.84|||Regression, Logistic||A value greater than one favours bisolviral|||1.840|0.666|0.6954
71806147|NCT02388724|143113028|NON_INFERIORITY|If the lower bound of the 95% confidence intervals of the difference was more than -10% (non-inferiority margin), non-inferiority for Vonoprazan relative to Lansoprazole was declared.|Difference in percentages|1.1|||||TWO_SIDED|95.0|-3.822|6.087||||||||6.087|-3.822|
71806148|NCT02388724|143113029|SUPERIORITY||Difference in percentages|7.2|||||TWO_SIDED|95.0|-1.054|15.371||||||2 Weeks||15.371|-1.054|
71806149|NCT02388724|143113029|SUPERIORITY||Difference in percentages|1.8|||||TWO_SIDED|95.0|-4.763|8.395||||||4 Weeks||8.395|-4.763|
71806150|NCT02605954|143113040|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.|Difference in Percentages|-4.4||||0.15|TWO_SIDED|95.0|-9.4|1.9|||Fisher Exact|||||1.9|-9.4|0.15
71842415|NCT04881461|143196285|SUPERIORITY||Mean Difference (Final Values)|1.33||||0.0417|TWO_SIDED|95.0|-0.01|2.67||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.67|-0.01|0.0417
71842416|NCT04881461|143196286|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.4984|TWO_SIDED|95.0|-0.15|0.3||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.30|-0.15|0.4984
71842417|NCT04881461|143196287|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.4438|TWO_SIDED|95.0|-0.12|0.27||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.27|-0.12|0.4438
71842418|NCT04881461|143196288|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.0363|TWO_SIDED|95.0|0.01|0.38||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.38|0.01|0.0363
71842419|NCT04881461|143196289|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.0329|TWO_SIDED|95.0|0.06|2.31||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand.."||2.31|0.06|0.0329
71842420|NCT04881461|143196290|SUPERIORITY||Mean Difference (Final Values)|1.73||||0.0016|TWO_SIDED|95.0|0.66|2.79||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||2.79|0.66|0.0016
71842421|NCT04881461|143196291|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4502|TWO_SIDED|95.0|-0.42|0.92||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.92|-0.42|0.4502
71842422|NCT04881461|143196292|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.1177|TWO_SIDED|95.0|-0.14|1.23||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.23|-0.14|0.1177
71842423|NCT04881461|143196293|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.4604|TWO_SIDED|95.0|-0.37|0.79||Observed P-value|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||0.79|-0.37|0.4604
71842424|NCT04881461|143196294|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.0549|TWO_SIDED|95.0|-0.01|1.15||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.15|-0.01|0.0549
71842425|NCT04881461|143196295|SUPERIORITY||Mean Difference (Final Values)|1.12||||0.0049|TWO_SIDED|95.0|0.3|1.93||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.93|0.30|0.0049
71842426|NCT04881461|143196296|SUPERIORITY||Mean Difference (Final Values)|1.24||||0.0004|TWO_SIDED|95.0|0.54|1.95||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.95|0.54|0.0004
71842427|NCT04881461|143196297|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.0054|TWO_SIDED|95.0|0.25|1.63||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.63|0.25|0.0054
71842428|NCT04881461|143196298|SUPERIORITY||Mean Difference (Final Values)|1.11||||0.0002|TWO_SIDED|95.0|0.52|1.71||Observed P-value.|Mixed Models Analysis|Covariates in the model: treatment, season and their interaction, ongoing asthma status, and country and season interaction|Placebo vs 5-grass mix SLIT-drops|"The null hypothesis was defined as no difference in means between treatment arms. The analysis was based on a 5% significance level. The endpoint was analysed using primary (trial product) estimand."||1.71|0.52|0.0002
71842429|NCT04084574|143196324|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_DEVIATION|13.5||0.3968|TWO_SIDED|95.0|-16.8|6.9||The threshold for statistical significance is p = 0.05|t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||6.9|-16.8|0.3968
71842430|NCT04084574|143196325|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_DEVIATION|0.5||0.07926|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||0.44|-0.33|0.07926
71842431|NCT04084574|143196327|SUPERIORITY||Mean Difference (Net)|11.7|STANDARD_DEVIATION|59.3||0.0673|TWO_SIDED|95.0|-34.2|58.6|||t-test, 2 sided|||||58.6|-34.2|0.0673
71842432|NCT04084574|143196328|SUPERIORITY||Mean Difference (Net)|-10.7|STANDARD_DEVIATION|189.3||0.8821|TWO_SIDED|95.0|-157.8|136.4|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||136.4|-157.8|0.8821
71842433|NCT04084574|143196329|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|3.3||0.6479|TWO_SIDED|95.0|-2.0|3.1|||t-test, 2 sided||Between group difference from baseline for Standard of Care group minus Behavioral Diet Counseling group.|||3.1|-2.0|0.6479
71842434|NCT04084574|143196330|SUPERIORITY||Mean Difference (Net)|7.0|STANDARD_DEVIATION|21.8||0.4044|TWO_SIDED|95.0|-10.0|24.0|||t-test, 2 sided||Between group difference in mean blood pressure change from baseline for Behavioral Diet Counseling group minus Standard of Care group.|||24.0|-10.0|0.4044
71842435|NCT04084574|143196331|SUPERIORITY||Mean Difference (Net)|1.34|STANDARD_DEVIATION|2.91||0.2374|TWO_SIDED|95.0|-0.97|3.6|||t-test, 2 sided|||||3.60|-0.97|0.2374
71842436|NCT04084574|143196332|SUPERIORITY||Mean Difference (Net)|-2.69|STANDARD_DEVIATION|13.62||0.6188|TWO_SIDED|95.0|-13.71|8.33|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||8.33|-13.71|0.6188
71842437|NCT04084574|143196333|SUPERIORITY||Mean Difference (Net)|-1.39|STANDARD_DEVIATION|1.79||0.0546|TWO_SIDED|95.0|-2.82|0.03|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.03|-2.82|0.0546
71675829|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-1.55|||||TWO_SIDED|95.0|-6.05|2.58|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 120||2.58|-6.05|
71842438|NCT04084574|143196334|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_DEVIATION|1.2||1|TWO_SIDED|95.0|-0.98|0.98|||t-test, 2 sided||Between group difference from 12 weeks to 24 weeks for Behavioral Diet Counseling group minus Standard of Care group.|||0.98|-0.98|1.00
71842439|NCT04084574|143196335|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|1.5||1|TWO_SIDED|95.0|-0.89|1.49|||t-test, 2 sided|||||1.49|-0.89|1.00
71842440|NCT02905331|143196336|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71842441|NCT02905331|143196337|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71842442|NCT02905331|143196342|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71842443|NCT04102111|143196347|OTHER||Least Squares Means|37.4||||0.288|TWO_SIDED|90.0|-21.0|95.8|||Mixed Model for Repeated Measures (MMRM)|||||95.8|-21.0|0.288
71842444|NCT02641730|143196354|SUPERIORITY||Mean Difference (Final Values)|-7.69|STANDARD_ERROR_OF_MEAN|1.674|<|0.001|TWO_SIDED|95.0|-11.0|-4.383|||Mixed-Model for Repeated Measures|||||-4.383|-11.000|<0.001
71842445|NCT02641730|143196354|SUPERIORITY||Mean Difference (Final Values)|-4.11|STANDARD_ERROR_OF_MEAN|1.7||0.017|TWO_SIDED|95.0|-7.468|-0.748|||Mixed-Model for Repeated Measures|||||-0.748|-7.468|0.017
71842446|NCT02326974|143196447|SUPERIORITY||||||<|0.001|||||||Mantel Haenszel|||By estimating that the overall pCR with T-DM1 plus pertuzumab would be approximately 40%, and 20% of the population classified as heterogeneous, the study would have 80% power with 136 evaluable patients to detect a difference in pCR of 44.9% in the non-heterogenous versus 20.3% in the heterogenous subgroup. The study had a 90% power to detect difference in pCR of 43.4% in the non-heterogenous versus 8.8% in the heterogenous subgroup if the observed prevalence of HER2 heterogeneity was 10%.||||<0.001
71842447|NCT04424316|143196483|OTHER||Vaccine Efficacy|57.6|||||TWO_SIDED|95.0|31.3|74.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|31.3|
71842448|NCT04424316|143196484|OTHER||Vaccine Efficacy|54.5|||||TWO_SIDED|95.0|33.2|69.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||69.5|33.2|
71842449|NCT04424316|143196485|OTHER||Vaccine Efficacy|50.0|||||TWO_SIDED|95.0|30.3|64.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||64.5|30.3|
71675830|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|2.42|||||TWO_SIDED|95.0|-2.12|7.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||7.44|-2.12|
71675831|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|0.83|||||TWO_SIDED|95.0|-3.41|5.24|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||5.24|-3.41|
71842450|NCT04424316|143196486|OTHER||Vaccine Efficacy|49.2|||||TWO_SIDED|95.0|31.4|62.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||62.8|31.4|
71842451|NCT04424316|143196487|OTHER||Vaccine Efficacy|82.4|||||TWO_SIDED|95.0|57.5|93.9||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||93.9|57.5|
71842452|NCT04424316|143196488|OTHER||Vaccine Efficacy|73.5|||||TWO_SIDED|95.0|50.3|86.8||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.8|50.3|
71842453|NCT04424316|143196489|OTHER||Vaccine Efficacy|70.5|||||TWO_SIDED|95.0|49.4|83.6||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||83.6|49.4|
71842454|NCT04424316|143196490|OTHER||Vaccine Efficacy|70.0|||||TWO_SIDED|95.0|50.6|82.5||||||Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||82.5|50.6|
71675832|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-1.59|||||TWO_SIDED|95.0|-6.67|3.17|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-2 at Day 270||3.17|-6.67|
71675833|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|2.93|||||TWO_SIDED|95.0|-3.07|9.06|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||9.06|-3.07|
71675834|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-0.81|||||TWO_SIDED|95.0|-6.17|4.44|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||4.44|-6.17|
71675835|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-3.73|||||TWO_SIDED|95.0|-9.74|2.03|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 120||2.03|-9.74|
71675836|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|6.79|||||TWO_SIDED|95.0|-1.03|14.56|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||14.56|-1.03|
71675837|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|3.0|||||TWO_SIDED|95.0|-4.28|10.23|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||10.23|-4.28|
71675838|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-3.79|||||TWO_SIDED|95.0|-11.97|4.39|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-3 at Day 270||4.39|-11.97|
71675839|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-2.5|||||TWO_SIDED|95.0|-7.68|1.55|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||1.55|-7.68|
71675840|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|0.04|||||TWO_SIDED|95.0|-5.47|5.62|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||5.62|-5.47|
71675841|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|2.54|||||TWO_SIDED|95.0|-1.52|7.81|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 120||7.81|-1.52|
71806151|NCT02605954|143113041|NON_INFERIORITY|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with \> 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.|Difference in Percentages|-3.8||||0.17|TWO_SIDED|95.0|-8.3|1.6|||Fisher Exact|||||1.6|-8.3|0.17
71842455|NCT04424316|143196506|OTHER||Vaccine efficacy|69.7|||||TWO_SIDED|95.0|37.1|86.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||86.7|37.1|
71675842|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|-1.52|||||TWO_SIDED|95.0|-9.14|5.69|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||5.69|-9.14|
71675843|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|1.13|||||TWO_SIDED|95.0|-6.9|8.95|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||8.95|-6.90|
71675844|NCT03423173|142869328|OTHER||Seropositivity Rate Difference|2.64|||||TWO_SIDED|95.0|-4.68|10.18|||||95% CI for the differences in seropositivity rates between TDV lots were calculated using the Newcombe and Wilson method.|DENV-4 at Day 270||10.18|-4.68|
71675845|NCT03423173|142869329|OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.42|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.42|0.56|
71675846|NCT03423173|142869329|OTHER||GMT Ratio|0.81|||||TWO_SIDED|95.0|0.51|1.28|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.28|0.51|
71675847|NCT03423173|142869329|OTHER||GMT Ratio|0.73|||||TWO_SIDED|95.0|0.46|1.16|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-1||1.16|0.46|
71675848|NCT03423173|142869329|OTHER||GMT Ratio|1.37|||||TWO_SIDED|95.0|1.02|1.86|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.86|1.02|
71842456|NCT04424316|143196506|OTHER||Vaccine efficacy|61.5|||||TWO_SIDED|95.0|28.6|80.3||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||80.3|28.6|
71894430|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|-1.16|||||TWO_SIDED|95.0|-6.32|3.1||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||3.10|-6.32|
71675849|NCT03423173|142869329|OTHER||GMT Ratio|0.65|||||TWO_SIDED|95.0|0.48|0.87|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||0.87|0.48|
71675850|NCT03423173|142869329|OTHER||GMT ratio|0.89|||||TWO_SIDED|95.0|0.66|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-2||1.21|0.66|
71675851|NCT03423173|142869329|OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.0|1.94|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.94|1.00|
71675852|NCT03423173|142869329|OTHER||GMT Ratio|0.88|||||TWO_SIDED|95.0|0.64|1.21|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.21|0.64|
71675853|NCT03423173|142869329|OTHER||GMT Ratio|1.23|||||TWO_SIDED|95.0|0.88|1.71|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-3||1.71|0.88|
71675854|NCT03423173|142869329|OTHER||GMT Ratio|0.83|||||TWO_SIDED|95.0|0.58|1.18|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.18|0.58|
71806152|NCT02605954|143113043|OTHER||Difference in least square mean|-36.0||||0.11|TWO_SIDED|95.0|-80.0|9.0|||ANOVA|||||9|-80|0.11
71806153|NCT03814889|143113242|OTHER|||||||0.00025|||||||Wilcoxon Signed-Rank|Paired, ordinal data||||||0.00025
71894431|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71894432|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|-8.72|||||TWO_SIDED|95.0|-21.93|4.42||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.42|-21.93|
71894433|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71675855|NCT03423173|142869329|OTHER||GMT Ratio|1.51|||||TWO_SIDED|95.0|1.07|2.14|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||2.14|1.07|
71675856|NCT03423173|142869329|OTHER||GMT Ratio|1.25|||||TWO_SIDED|95.0|0.88|1.78|||||ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor.|DENV-4||1.78|0.88|
71675857|NCT01028014|142869340|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
71806154|NCT03814889|143113243|OTHER|||||||0.0014|||||||Wilcoxon Signed-Rank|||||||0.0014
71806155|NCT03814889|143113244|OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
71806156|NCT03814889|143113245|OTHER|||||||0.001|||||||t-test, 1 sided|||||||0.001
71806157|NCT03814889|143113248|OTHER|||||||0.001|||||||Wilcoxcon Signed-Ranks|||||||0.001
71806158|NCT02522715|143113310|OTHER||||||<|0.01|||||||two-sided exact binomial test|||One-sample binomial test with null hypothesis that the percentage of participants with PSA response 1 is equal to 25%.||||<0.01
71806159|NCT03980470|143113319|SUPERIORITY|||||||0.198|||||||ANOVA|||||||0.198
71806160|NCT03980470|143113320|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
71806161|NCT03980470|143113321|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
71806162|NCT03980470|143113322|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71806163|NCT03980470|143113323|OTHER|Bland-Altmann analysis (bias)|Mean Difference (Final Values)|-1.42|||||TWO_SIDED|||||||||||||
71806164|NCT03858803|143113324|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806165|NCT03858803|143113325|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806166|NCT03858803|143113326|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806167|NCT03858803|143113327|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806168|NCT03858803|143113328|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806169|NCT03858803|143113329|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806170|NCT03858803|143113330|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806171|NCT03858803|143113331|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806172|NCT03858803|143113332|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806173|NCT03858803|143113333|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806174|NCT03858803|143113334|SUPERIORITY||||||<|0.05|||||||MANOVA|||||||<.05
71806175|NCT01358526|143113339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.163||0.0055|TWO_SIDED|95.0|0.13|0.77||A gate-keeping strategy and a Bonferroni-Holm method was used to control the family-wise (primary and secondary efficacy analysis) error rate at the 5% level.|Mixed Models Analysis|Mixed-model repeated measures analysis of pain data using a pattern mixture model framework||||0.77|0.13|0.0055
71806176|NCT01358526|143113340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.26||0.0191|TWO_SIDED|95.0|0.9|9.8|||Mixed Models Analysis|Mixed-model repeated measures analysis|Mean difference (final values) is the treatment comparison estimated using mixed model repeated measures analysis with effect for treatment, time (weeks 4, 8, 12), treatment by time interaction, and prerandomization value. Subject is a random effect.|||9.8|0.9|0.0191
71806177|NCT01358526|143113341|SUPERIORITY_OR_OTHER|||||||0.0002||||||"The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test"|Fisher Exact|||||||0.0002
71806178|NCT01358526|143113342|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 30%||||0.0006
71806179|NCT01358526|143113343|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 50%||||0.0018
71806180|NCT02194621|143113417|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
71806181|NCT02194621|143113418|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71806182|NCT02194621|143113419|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||>0.05
71806183|NCT02194621|143113420|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.002
71806184|NCT00791765|143113563|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||van Elteren's test|Stratified by baseline body mass index group||||||<0.0001
71806185|NCT00791765|143113564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline body mass index group||||||<0.0001
71842457|NCT04424316|143196506|OTHER||Vaccine efficacy|57.1|||||TWO_SIDED|95.0|23.9|76.8||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||76.8|23.9|
71675858|NCT01028014|142869341|SUPERIORITY_OR_OTHER||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all \>0.05.P-values were not adjusted for multiple testing; p\<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.||||>0.05
71675859|NCT01631149|142869345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|0.4|<|0.001|||||||t-test, 2 sided|||"The individual scores obtained during surgery were averaged.~The average values were compared using a t-test between treatments."||||<0.001
71675860|NCT00943150|142869367|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
71675861|NCT00943150|142869368|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||ANOVA|||CD3+ at 0 weeks||||0.33
71675862|NCT00943150|142869368|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||CD3+ at 3 weeks||||0.02
71675863|NCT00943150|142869368|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||ANOVA|||CD3+ at 6 weeks||||0.71
71842458|NCT04424316|143196506|OTHER||Vaccine efficacy|55.3|||||TWO_SIDED|95.0|23.8|74.6||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||74.6|23.8|
71842459|NCT04424316|143196506|OTHER||Vaccine efficacy|24.2|||||TWO_SIDED|95.0|-11.1|48.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. Vaccine efficacy was presented in percentage.||48.6|-11.1|
71842460|NCT04424316|143196507|OTHER||Vaccine efficacy|9.5|||||TWO_SIDED|95.0|-10.1|25.7||||||Vaccine efficacy within 90 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||25.7|-10.1|
71675864|NCT00943150|142869368|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||CD68+ at 0 weeks||||0.67
71675865|NCT00943150|142869368|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||CD68+ at 3 weeks||||0.01
71675866|NCT00943150|142869368|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|||CD68+ at 6 weeks||||0.48
71842461|NCT04424316|143196507|OTHER||Vaccine efficacy|6.7|||||TWO_SIDED|95.0|-9.8|20.7||||||Vaccine efficacy within 120 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.7|-9.8|
71675867|NCT00943150|142869369|SUPERIORITY_OR_OTHER|||||||0.1128||95.0|||||Exact Wilcoxon rank-sum test|||||||0.1128
71675868|NCT00943150|142869370|SUPERIORITY_OR_OTHER|||||||0.0898||95.0|||||Exact Wilcoxon test|||||||0.0898
71842462|NCT04424316|143196507|OTHER||Vaccine efficacy|7.7|||||TWO_SIDED|95.0|-6.5|20.1||||||Vaccine efficacy within 150 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||20.1|-6.5|
71675869|NCT00943150|142869371|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||Exact Wilcoxon test|||Intraoperative narcotic use comparison||||0.0760
71842463|NCT04424316|143196507|OTHER||Vaccine efficacy|4.1|||||TWO_SIDED|95.0|-9.5|16.0||||||Vaccine efficacy within 180 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||16.0|-9.5|
71675870|NCT00943150|142869371|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Exact Wilcoxon test|||Postoperative narcotic use comparison||||0.5900
71675871|NCT00943150|142869372|SUPERIORITY_OR_OTHER|||||||0.4589||95.0|||||Exact Wilcoxon test|||||||0.4589
71675872|NCT00943150|142869373|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Exact Wilcoxon test|||||||0.999
71675873|NCT00943150|142869374|SUPERIORITY_OR_OTHER|||||||0.0412||95.0|||||Exact Wilcoxon test|||||||0.0412
71675874|NCT03315286|142869375|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71675875|NCT03315286|142869376|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71675876|NCT03315286|142869377|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Baseline results are reported here.||||0.6
71675877|NCT03315286|142869377|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||6 month data is reported here||||0.3
71675878|NCT03315286|142869378|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Baseline data is reported here.||||0.2
71675879|NCT03315286|142869378|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||6 month data is reported here||||0.4
71675880|NCT03315286|142869379|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||baseline data is reported here||||0.07
71675881|NCT03315286|142869379|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||6 month data is reported here||||0.0002
71675882|NCT03075891|142869381|SUPERIORITY|||||||0.032|||||||Cochran-Mantel-Haenszel|||||||0.032
71675883|NCT00828568|142869409|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder's method with Yate's continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product.|Mean Difference (Final Values)|4.85||||||90.0|-5.37|15.08||||||||15.08|-5.37|
71675884|NCT00828568|142869411|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71675885|NCT00828568|142869411|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<.0001
71894434|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71806186|NCT00791765|143113565|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided pairwise van Elteren's test|Stratified by baseline body mass index group||Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)||||<0.0001
71806187|NCT00791765|143113566|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided test with modified ridit scores stratified by baseline body mass index group||||||<0.0001
71806188|NCT00377234|143113588|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P \<0.05|Garts Test|||||||<0.0001
71806189|NCT00377234|143113588|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.|Prescott Test|||||||<0.0001
71806190|NCT01880424|143113593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.001||95.0|1.21|2.09||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||2.09|1.21|0.0010
71806191|NCT01880424|143113594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.56|||<|0.0001||95.0|1.83|3.58||Statistical significance (p\<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.||3.58|1.83|<0.0001
71806192|NCT00907153|143113602|SUPERIORITY||Mean Difference (Net)|-0.017||||0.05|TWO_SIDED|95.0|-0.034|0.0|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.000|-0.034|0.05
71806193|NCT00907153|143113603|SUPERIORITY||Mean Difference (Net)|-1.14||||0.62|TWO_SIDED|95.0|-5.89|3.62|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||3.62|-5.89|0.62
71806194|NCT00907153|143113604|SUPERIORITY||Mean Difference (Net)|-3.65||||0.48|TWO_SIDED|95.0|-14.32|7.02|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.02|-14.32|0.48
71806195|NCT00907153|143113605|SUPERIORITY||Mean Difference (Net)|-6.51||||0.02|TWO_SIDED|95.0|-12.07|-0.96|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||-0.96|-12.07|0.02
71806196|NCT00907153|143113606|SUPERIORITY||Mean Difference (Net)|6.28||||0.22|TWO_SIDED|95.0|-3.97|16.54|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||16.54|-3.97|0.22
71806197|NCT00907153|143113607|SUPERIORITY||Mean Difference (Net)|13.84||||0.33|TWO_SIDED|95.0|-210.29|37.98|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||37.98|-210.29|0.33
71806198|NCT00907153|143113608|SUPERIORITY||Mean Difference (Net)|-12.8||||0.39|TWO_SIDED|95.0|-42.94|17.34|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||17.34|-42.94|0.39
71806199|NCT00907153|143113609|SUPERIORITY||Mean Difference (Net)|-75.08||||0.09|TWO_SIDED|95.0|-161.9|11.78|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||11.78|-161.9|0.09
71806200|NCT00907153|143113610|SUPERIORITY||Mean Difference (Net)|0.73||||0.96|TWO_SIDED|95.0|-32.59|34.06|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||34.06|-32.59|0.96
71806201|NCT00907153|143113611|SUPERIORITY||Mean Difference (Net)|3.08||||0.21|TWO_SIDED|95.0|-1.84|7.99|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||7.99|-1.84|0.21
71806202|NCT00907153|143113612|SUPERIORITY||Mean Difference (Net)|0.11||||0.99|TWO_SIDED|95.0|-24.43|24.64|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||24.64|-24.43|0.99
71806203|NCT00907153|143113613|SUPERIORITY||Median Difference (Net)|-1.93||||0.62|TWO_SIDED|95.0|-10.12|6.26|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||6.26|-10.12|0.62
71806204|NCT00907153|143113614|SUPERIORITY||Mean Difference (Net)|0.28||||0.98|TWO_SIDED|95.0|-20.29|20.85|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||20.85|-20.29|0.98
71806205|NCT00907153|143113615|SUPERIORITY||Mean Difference (Net)|10.24||||0.64|TWO_SIDED|95.0|-34.61|55.08|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||55.08|-34.61|0.64
71806206|NCT00907153|143113616|SUPERIORITY||Mean Difference (Net)|0.88||||0.88|TWO_SIDED|95.0|-22.81|8.51|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||8.51|-22.81|0.88
71806207|NCT00907153|143113617|SUPERIORITY||Mean Difference (Net)|-3.15||||0.25|TWO_SIDED|95.0|-8.7|2.41|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||2.41|-8.70|0.25
71806208|NCT00907153|143113618|SUPERIORITY||Mean Difference (Net)|44.31|||<|0.001|TWO_SIDED|95.0|27.13|61.48|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||61.48|27.13|<0.001
71806209|NCT00907153|143113619|SUPERIORITY||Mean Difference (Net)|1.56||||0.38|TWO_SIDED|95.0|-2.08|5.2|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||5.20|-2.08|0.38
71806210|NCT00907153|143113620|SUPERIORITY||Mean Difference (Net)|-7.84||||0.46|TWO_SIDED|95.0|-29.34|13.67|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.||||13.67|-29.34|0.46
71842464|NCT04424316|143196507|OTHER||Vaccine efficacy|4.6|||||TWO_SIDED|95.0|-6.6|14.6||||||Vaccine efficacy within 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||14.6|-6.6|
71842465|NCT04424316|143196508|OTHER||Vaccine efficacy|43.8|||||TWO_SIDED|95.0|25.6|57.7||||||Vaccine efficacy at 210 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||57.7|25.6|
71842466|NCT04424316|143196508|OTHER||Vaccine efficacy|39.7|||||TWO_SIDED|95.0|21.3|54.1||||||Vaccine efficacy at 240 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||54.1|21.3|
71842467|NCT04424316|143196508|OTHER||Vaccine efficacy|35.0|||||TWO_SIDED|95.0|16.1|49.9||||||Vaccine efficacy at 270 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||49.9|16.1|
71842468|NCT04424316|143196508|OTHER||Vaccine efficacy|33.0|||||TWO_SIDED|95.0|15.2|47.1||||||Vaccine efficacy at 360 days after birth. Vaccine efficacy was calculated as 1-(P/\[1-P\]), where P is the number of cases in the RSVpreF group divided by the total number of cases. The confidence interval was adjusted using Bonferroni procedure and accounting for the primary endpoints results. Vaccine efficacy was presented in percentage.||47.1|15.2|
71675886|NCT02477332|142869413|SUPERIORITY||Estimated target dose|32.5|||<|0.05|TWO_SIDED|60.0|27.5|42.5|||Regression, Logistic|Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.|Min dose with effect size \>15%|||42.5|27.5|<.05
71806211|NCT03147248|143113622|NON_INFERIORITY|The non-inferiority was to be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change from baseline of DAS28 (CRP) at Week 22 was greater that the pre-specified non-inferiority margin of -0.6.|Difference of Least square mean|0.27|||||TWO_SIDED|95.0|0.02|0.52|||||The least squares means and standard errors, estimate of treatment difference (CT-P13 SC 120 mg - CT-P13 IV 3 mg/kg), and 2-sided 95% CI obtained from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA considering the treatment as fixed effect and country, serum CRP concentration at Week 2 (≤0.6 mg/dL vs. \>0.6 mg/dL), and body weight at Week 6 (≤100 kg vs. \>100 kg) as covariates.||0.52|0.02|
71806212|NCT02103439|143113637|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95% confidence interval for the difference in proportions between the difference in the early virological response rate with Algeron and PegIntron should be higher than the non-inferiority margin of 0.2 (-20%)||||||0.227|TWO_SIDED||||||Fisher Exact|||||||0.227
71806213|NCT02103439|143113638|NON_INFERIORITY_OR_EQUIVALENCE|the lower limit of the 95 % confidence interval between the difference in rate of rapid virological response with Algeron and PegIntron should be more than the non-inferiority margin (-20 %)|||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||> 0.05
71806214|NCT00321854|143113685|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.9||0.6503||95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6503
71806215|NCT00321854|143113686|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.9568||95.0|-1.7|1.8|||ANCOVA|||||1.8|-1.7|0.9568
71806216|NCT00321854|143113687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.3|-3.2|||ANCOVA|||||-3.2|-6.3|<0.0001
71894435|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71894436|NCT01193335|143310976|SUPERIORITY_OR_OTHER||Percent difference|0.0|||||TWO_SIDED|95.0|-4.25|4.31||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.||4.31|-4.25|
71675887|NCT02549287|142869426|SUPERIORITY||Odds Ratio, log|0.55||||0.12|TWO_SIDED|95.0|-0.11|1.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.20|-0.11|0.12
71806217|NCT00321854|143113688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.8|-3.0|||ANCOVA|||||-3|-5.8|<0.0001
71806218|NCT00321854|143113689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.1|-1.7|||ANCOVA|||||-1.7|-4.1|<0.0001
71806219|NCT00321854|143113690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.9||0.8693||95.0|-1.8|1.5|||ANCOVA|||||1.5|-1.8|0.8693
71806220|NCT00321854|143113691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.9||0.8155||95.0|-1.5|1.9|||ANCOVA|||||1.9|-1.5|0.8155
71806221|NCT00321854|143113692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001||95.0|-6.0|-3.0|||ANCOVA|||||-3|-6|<0.0001
71806222|NCT00321854|143113693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001||95.0|-5.4|-2.6|||ANCOVA|||||-2.6|-5.4|<0.0001
71806223|NCT00321854|143113694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-3.9|-1.7|||ANCOVA|||||-1.7|-3.9|<0.0001
71806224|NCT00321854|143113695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7999||95.0|-1.5|1.1|||ANCOVA|||||1.1|-1.5|0.7999
71806225|NCT00321854|143113696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7395||95.0|-1.1|1.5|||ANCOVA|||||1.5|-1.1|0.7395
71806226|NCT00321854|143113697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.5|-2.2|||ANCOVA|||||-2.2|-4.5|<0.0001
71806227|NCT00321854|143113698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001||95.0|-4.0|-1.8|||ANCOVA|||||-1.8|-4|<0.0001
71806228|NCT00321854|143113699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.5||0.0002||95.0|-2.7|-0.9|||ANCOVA|||||-0.9|-2.7|0.0002
71806229|NCT00321854|143113700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9256||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9256
71806230|NCT00321854|143113701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9792||95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.9792
71806231|NCT00321854|143113702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0001||95.0|-1.7|-0.5|||ANCOVA|||||-0.5|-1.7|0.0001
71806232|NCT00321854|143113703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|-1.6|-0.6|||ANCOVA|||||-0.6|-1.6|<0.0001
71806233|NCT00321854|143113704|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001||95.0|-1.5|-0.6|||ANCOVA|||||-0.6|-1.5|<0.0001
71806234|NCT00321854|143113705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0376||95.0|-0.5|0.0|||ANCOVA|||||0|-0.5|0.0376
71675888|NCT02549287|142869427|SUPERIORITY||Odds Ratio, log|0.41||||0.14|TWO_SIDED|95.0|-0.2|1.03||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.03|-0.20|0.14
71806235|NCT00321854|143113706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1607||95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.1607
71806236|NCT00321854|143113707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0173||95.0|-0.5|-0.1|||ANCOVA|||||-0.1|-0.5|0.0173
71806237|NCT00321854|143113708|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0007||95.0|-0.6|-0.2|||ANCOVA|||||-0.2|-0.6|0.0007
71806238|NCT00321854|143113709|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4381||95.0|-0.3|0.1|||ANCOVA|||||0.1|-0.3|0.4381
71806239|NCT00321854|143113710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.796||||0.5116||95.0|0.403|1.573|||Regression, Logistic|||||1.573|0.403|0.5116
71806240|NCT00321854|143113711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.7913||95.0|0.403|3.299|||Regression, Logistic|||The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression||3.299|0.403|0.7913
71806241|NCT00321854|143113712|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1702||95.0|-1.3|0.2|||ANCOVA|||||0.2|-1.3|0.1702
71806242|NCT00321854|143113713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0009||95.0|-2.2|-0.6|||ANCOVA|||||-0.6|-2.2|0.0009
71806243|NCT00321854|143113714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.0005||95.0|-2.1|-0.6|||ANCOVA|||||-0.6|-2.1|0.0005
71806244|NCT00321854|143113715|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0422||95.0|-1.4|0.0|||ANCOVA|||||0|-1.4|0.0422
71806245|NCT00321854|143113716|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.573||||0.2149||95.0|-1.823|0.677|||Wilcoxon (Mann-Whitney)|||||0.677|-1.823|0.2149
71806246|NCT00321854|143113717|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.031||||0.0001||95.0|-3.125|-0.938|||Wilcoxon (Mann-Whitney)|||||-0.938|-3.125|0.0001
71806247|NCT00321854|143113718|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.2605||95.0|0.0|0.026|||Wilcoxon (Mann-Whitney)|||||0.026|0|0.2605
71806248|NCT00321854|143113719|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.051|||<|0.0001||95.0|0.0|0.089|||Wilcoxon (Mann-Whitney)|||||0.089|0|<0.0001
71806249|NCT00321854|143113720|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.0||||0.0489||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0489
71806250|NCT00321854|143113721|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.0||||0.0282||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|||||5|0|0.0282
71806251|NCT00321854|143113737|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.8397||95.0|-5.4|4.4|||ANCOVA|||||4.4|-5.4|0.8397
71813588|NCT04858802|143129486|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|2.26||1|TWO_SIDED|95.0|-0.5|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 90||0.5|-0.5|1.00
71813589|NCT04858802|143129486|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|2.16||0.188|TWO_SIDED|95.0|-0.8|0.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean CRS side-specific symptom total score minus balloon sinus dilation alone mean CRS side-specific symptom total score|Day 180||0.2|-0.8|0.188
71813590|NCT04858802|143129490|SUPERIORITY||Mean Difference (Net)|6.28|STANDARD_DEVIATION|18.12||0.025|TWO_SIDED|95.0|0.8|11.7||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area minus balloon sinus dilation alone mean FSO cross-sectional area|||11.7|0.8|0.025
71813591|NCT04858802|143129491|SUPERIORITY||Mean Difference (Final Values)|3.98|STANDARD_DEVIATION|12.49||0.04|TWO_SIDED|95.0|0.2|7.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 45 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 45|Day 45||7.8|0.2|0.04
71813592|NCT04858802|143129491|SUPERIORITY||Median Difference (Final Values)|-3.45|STANDARD_DEVIATION|13.02||0.09|TWO_SIDED|95.0|-7.5|0.6||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO cross-sectional area change from baseline to Day 180 minus balloon sinus dilation alone mean FSO cross-sectional area change from baseline to Day 180|Day 180||0.6|-7.5|0.09
71813593|NCT04858802|143129492|SUPERIORITY||Mean Difference (Final Values)|61.54|STANDARD_DEVIATION|460.18||0.375|TWO_SIDED|95.0|-76.7|199.8||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 45||199.8|-76.7|0.375
71806252|NCT03204279|143113744|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|0.076||||0.55|TWO_SIDED|||||CR in the delayed phase vs AUC0-inf|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs AUC0-inf|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.55
71675889|NCT02549287|142869428|SUPERIORITY||Odds Ratio, log|0.44||||0.2|TWO_SIDED|95.0|-0.2|1.07||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.07|-0.20|0.20
71806253|NCT03204279|143113744|OTHER|No comparison between the two dose groups is performed, thus no statistical test is applied. In the next section the goodness of fit of the loess function correlating exposure and response is reported.|Pearson R|-0.041||||0.75|TWO_SIDED|||||CR in the delayed phase vs Cmax|loess (Local regression or polynomial)|The p-value represents the probability found if the correlation coefficient was zero (null hypothesis).|R is the Pearson correlation is a coefficient statistic that measures linear correlation between two variables CR in the delayed phase vs Cmax|The population consist of all patients having CR in the delayed phase and AUC0-inf and Cmax, there is no comparison between the two dose groups.||||0.75
71806254|NCT01981564|143113929|SUPERIORITY|||||||0.06|||||||ANOVA|||ANOVA F=3.55, df=1, p=0.06||||0.06
71806255|NCT02647359|143113981|OTHER||Least Square (LS) Mean Difference|10.76||||0.4868|TWO_SIDED|95.0|-21.914|43.434||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with age and baseline Maximum Reading Speed (both eyes) as covariates, and treatment as a factor.||43.434|-21.914|0.4868
71806256|NCT04818346|143114020|SUPERIORITY||Least squares mean difference|-21.41|STANDARD_ERROR_OF_MEAN|6.62||0.0015|TWO_SIDED|95.0|-34.49|-8.32|||Mixed Model Repeated Measures (MMRM)|||||-8.32|-34.49|0.0015
71806257|NCT04818346|143114020|SUPERIORITY||Least squares mean difference|-20.07|STANDARD_ERROR_OF_MEAN|6.86||0.004|TWO_SIDED|95.0|-33.63|-6.51|||MMRM|||||-6.51|-33.63|0.0040
71806258|NCT04818346|143114020|SUPERIORITY||Least squares mean difference|-18.02|STANDARD_ERROR_OF_MEAN|6.77||0.0086|TWO_SIDED|95.0|-31.4|-4.64|||MMRM|||||-4.64|-31.40|0.0086
71806259|NCT04818346|143114021|SUPERIORITY||Odds Ratio (OR)|4.3||||0.3574|TWO_SIDED|95.0|0.398|220.998|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||220.998|0.398|0.3574
71806260|NCT04818346|143114021|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1992|TWO_SIDED|95.0|0.573|273.479|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||273.479|0.573|0.1992
71806261|NCT04818346|143114021|SUPERIORITY||Odds Ratio (OR)|2.1||||0.9913|TWO_SIDED|95.0|0.103|126.386|||Wald test||Logistic regression: (response at Week 24 = treatment + stratification factor \[T-BSA involvement 8%-20%/\>20%\]).|||126.386|0.103|0.9913
71894437|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.6|0.97||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.97|0.60|
71675890|NCT02549287|142869429|SUPERIORITY||Odds Ratio, log|-0.07||||0.77|TWO_SIDED|95.0|-0.58|0.43||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.43|-0.58|0.77
71806262|NCT01362140|143114027|SUPERIORITY_OR_OTHER|||||||0.008|||||||Chi-squared|||"The primary hypothesis to be tested was that the percentage of participants with at least~1 RBC transfusion from week 5 to the EOTP was lower in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if the incidence of RBC transfusion in the darbepoetin alfa group was lower and had a p-value \< 0.05 from a 2-sided Chi-square test."||||0.008
71806263|NCT01362140|143114028|SUPERIORITY_OR_OTHER|||||||0.017|||||||Cochran-Mantel-Haenszel|The overall 2-sided CMH test with IPSS score as stratification factor.||If the primary hypothesis was confirmed, the secondary hypothesis to be tested was that the percentage of participants achieving an IWG erythroid response during the 24-week double-blind treatment period was greater in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if erythroid response was higher in the darbepoetin alfa group and the p-value was \< 0.05 from a 2-sided Cochran-Mantel-Haenszel test using the IPSS as a stratification factor.||||0.017
71806264|NCT05054816|143114129|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections.||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
71806265|NCT05054816|143114130|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
71806266|NCT05054816|143114131|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
71806267|NCT05054816|143114132|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between two conditions: investigative feature, comparative feature 1|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
71806268|NCT05054816|143114133|SUPERIORITY||||||<|0.05||||||The p-value was adjusted for multiple comparisons between three conditions: investigative feature, comparative feature 1, comparative feature 2|ANOVA|The data were protected against deviations from sphericity by modifying degrees of freedom using Greenhouse-Geisser corrections||Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.||||<0.05
71806269|NCT02010060|143114231|SUPERIORITY|||||||0.074|||||||ANCOVA|||||||0.074
71806270|NCT02010060|143114231|SUPERIORITY|||||||0.684|||||||ANCOVA|||Change in waist circumference between AERO and CON||||0.684
71806271|NCT02010060|143114231|SUPERIORITY|||||||0.18|||||||ANCOVA|||Comparison between the AERO group and the AERO-PA group||||0.180
71806272|NCT02010060|143114232|SUPERIORITY|||||||0.011|||||||ANCOVA|||Change in body fat between the AERO-PA group and the CON group||||0.011
71806273|NCT02010060|143114232|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
71806274|NCT02010060|143114232|SUPERIORITY|||||||0.258|||||||ANCOVA|||Change in body fat between the AERO and AERO-PA group||||0.258
71806275|NCT02010060|143114233|SUPERIORITY|||||||0.104|||||||ANCOVA|||Comparison of body weight between the CON and AERO-PA groups||||0.104
71806276|NCT02010060|143114233|SUPERIORITY|||||||0.578|||||||ANCOVA|||Change in body weight between the CON and AERO groups||||0.578
71806277|NCT02010060|143114233|SUPERIORITY|||||||0.3|||||||ANCOVA|||Change in body weight between the AERO and AERO-PA groups||||0.300
71675891|NCT02549287|142869430|SUPERIORITY||Odds Ratio, log|0.35||||0.29|TWO_SIDED|95.0|-0.27|0.97|||Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.97|-0.27|0.29
71806278|NCT02010060|143114234|SUPERIORITY|||||||0.002|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.002
71806279|NCT02010060|143114234|SUPERIORITY|||||||0.314|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) AERO and CON groups||||0.314
71806280|NCT02010060|143114234|SUPERIORITY|||||||0.041|||||||ANCOVA|||Change in cardiorespiratory fitness (L/min) between the AERO and AERO-PA groups||||0.041
71806281|NCT02010060|143114235|SUPERIORITY|||||||0.891|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO-PA groups||||0.891
71806282|NCT02010060|143114235|SUPERIORITY|||||||0.417|||||||ANCOVA|||Change in insulin sensitivity between the CON and AERO groups||||0.417
71806283|NCT02010060|143114235|SUPERIORITY|||||||0.484|||||||ANCOVA|||Change in insulin sensitivity between the AERO and AERO-PA groups||||0.484
71806284|NCT02010060|143114236|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and the AERO groups||||0.274
71806285|NCT02010060|143114236|SUPERIORITY|||||||0.461|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between the CON and AERO groups||||0.461
71806286|NCT02010060|143114236|SUPERIORITY|||||||0.739|||||||ANCOVA|||Change in Low density lipoprotein (LDL) between AERO and AERO-PA groups||||0.739
71806287|NCT02010060|143114237|SUPERIORITY|||||||0.837|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO-PA group||||0.837
71806288|NCT02010060|143114237|SUPERIORITY|||||||0.895|||||||ANCOVA|||Change in high density lipoprotein (HDL) between the CON and AERO groups||||0.895
71806289|NCT02010060|143114237|SUPERIORITY|||||||0.744|||||||ANCOVA|||||||0.744
71806290|NCT02010060|143114238|SUPERIORITY|||||||0.067|||||||ANCOVA|||Change in total cholesterol (mg/dL)||||0.067
71806291|NCT02010060|143114238|SUPERIORITY|||||||0.254|||||||ANCOVA|||Change in total cholesterol (mg/dL) between the CON and AERO groups||||0.254
71806292|NCT02010060|143114238|SUPERIORITY|||||||0.501|||||||ANCOVA|||Change in total cholesterol (mg/dL) between AERO and AERO-PA groups||||0.501
71806293|NCT02010060|143114239|SUPERIORITY|||||||0.456|||||||ANCOVA|||Change in triglyceride level between the AERO-PA and CON groups||||0.456
71806294|NCT02010060|143114239|SUPERIORITY|||||||0.422|||||||ANCOVA|||Change in triglyceride level between the CON and AERO groups||||0.422
71806295|NCT02010060|143114239|SUPERIORITY|||||||0.136|||||||ANCOVA|||Change in triglyceride level between the AERO and AERO-PA groups||||0.136
71806296|NCT02010060|143114240|SUPERIORITY|||||||0.483|||||||ANCOVA|||Change in glucose level between the CON and AERO-PA groups||||0.483
71806297|NCT02010060|143114240|SUPERIORITY|||||||0.274|||||||ANCOVA|||Change in glucose between the CON and AERO groups||||0.274
71806298|NCT02010060|143114240|SUPERIORITY|||||||0.685|||||||ANCOVA|||Change in glucose level between the AERO and AERO-PA groups||||0.685
71806299|NCT02010060|143114241|SUPERIORITY|||||||0.489|||||||ANCOVA|||Change in systemic inflammation between CON and AERO-PA groups||||0.489
71806300|NCT02010060|143114241|SUPERIORITY|||||||0.652|||||||ANCOVA|||Change in systemic inflammation between the CON and AERO groups||||0.652
71806301|NCT02010060|143114241|SUPERIORITY|||||||0.822|||||||ANCOVA|||Change in systemic inflammation between the AERO and AERO-PA groups||||0.822
71806302|NCT02010060|143114242|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the CON group and the AERO-PA group||||<0.001
71806303|NCT02010060|143114242|SUPERIORITY|||||||0.648|||||||ANCOVA|||Changes in steps between the CON and the AERO group||||0.648
71806304|NCT02010060|143114242|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes in steps between the AERO and AERO-PA groups||||<0.001
71806305|NCT02010060|143114243|SUPERIORITY|||||||0.226|||||||ANCOVA|||Change in kilocalories (dietary intake) between CON and AERO-PA group||||0.226
71806306|NCT02010060|143114243|SUPERIORITY|||||||0.215|||||||ANCOVA|||Change in caloric intake between the CON and the AERO groups||||0.215
71806307|NCT02010060|143114243|SUPERIORITY|||||||0.957|||||||ANCOVA|||Change in caloric intake (kilocalories) between the AERO and AERO-PA groups||||0.957
71806308|NCT02010060|143114244|SUPERIORITY|||||||0.337|||||||ANCOVA|||Change in insulin concentration between the CON and AERO-PA group||||0.337
71806309|NCT02010060|143114244|SUPERIORITY|||||||0.77|||||||ANCOVA|||Change in insulin level between the AERO and CON groups||||0.770
71806310|NCT02010060|143114244|SUPERIORITY|||||||0.515|||||||ANCOVA|||Change in insulin concentration between AERO and AERO-PA groups||||0.515
71806311|NCT01369342|143114249|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806312|NCT01369342|143114249|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806313|NCT01369342|143114250|SUPERIORITY_OR_OTHER|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||0.009
71806314|NCT01369342|143114250|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806315|NCT01369342|143114251|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806316|NCT01369342|143114251|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806317|NCT01369342|143114252|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71842469|NCT00412607|143196529|SUPERIORITY_OR_OTHER_LEGACY||Percentage of mortality|13.3|||||ONE_SIDED|95.0||17.5|||Fisher Exact||The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.|"Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05."||17.5||
71894438|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.39|0.66||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.66|0.39|
71675892|NCT02549287|142869431|SUPERIORITY||Odds Ratio, log|0.49||||0.15|TWO_SIDED|95.0|-0.08|1.06||Other \[Marginal Model (e.g., GEE)\]|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||1.06|-0.08|0.15
71675893|NCT02549287|142869432|SUPERIORITY||Odds Ratio, log|-0.11||||0.61|TWO_SIDED|95.0|-0.73|0.52||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.52|-0.73|0.61
71806318|NCT01369342|143114252|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806319|NCT01369342|143114253|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806320|NCT01369342|143114253|SUPERIORITY_OR_OTHER||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=\< 300 or \>300).||||||< 0.001
71806321|NCT02566031|143114254|SUPERIORITY||Mean Difference (Net)|0.05||||0.0129|TWO_SIDED|95.0|0.011|0.093|||ANCOVA|||||0.093|0.011|0.0129
71806322|NCT02566031|143114255|SUPERIORITY||Mean Difference (Net)|0.06||||0.0058|TWO_SIDED|95.0|0.017|0.098|||ANCOVA|||-45 min||0.098|0.017|0.0058
71806323|NCT02566031|143114255|SUPERIORITY||Mean Difference (Net)|0.05||||0.0161|TWO_SIDED|95.0|0.009|0.091|||ANCOVA|||-15min||0.091|0.009|0.0161
71806324|NCT02566031|143114256|SUPERIORITY||Mean Difference (Net)|0.31||||0.0767|TWO_SIDED|95.0|-0.033|0.646|||ANCOVA|||||0.646|-0.033|0.0767
71806325|NCT02566031|143114257|SUPERIORITY||Mean Difference (Net)|-0.81||||0.1008|TWO_SIDED|95.0|-1.77|0.16|||ANCOVA|||||0.16|-1.77|0.1008
71806326|NCT00413153|143114259|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).||||0.035
71806327|NCT00413153|143114260|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs. LPV/r)||||0.12
71806328|NCT00413153|143114261|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.002
71806329|NCT00413153|143114262|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.02
71806330|NCT00413153|143114263|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|||||||0.047
71806331|NCT00413153|143114264|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.72
71806332|NCT00413153|143114265|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.22
71806333|NCT00413153|143114266|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Repeated Measures Ancova|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.004
71806334|NCT00413153|143114267|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).||||0.0002
71806335|NCT02479412|143114311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02691|STANDARD_ERROR_OF_MEAN|0.05697||0.6379|TWO_SIDED|95.0|-0.08626|0.1401|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||0.1401|-0.08626|0.6379
71806336|NCT02479412|143114311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07604|STANDARD_ERROR_OF_MEAN|0.05663||0.1827|TWO_SIDED|95.0|-0.03645|0.1885|||Mixed Models Analysis|||AZD7594 250 µg vs.PBO||0.1885|-0.03645|0.1827
71806337|NCT02479412|143114311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1478|STANDARD_ERROR_OF_MEAN|0.05679||0.0108|TWO_SIDED|95.0|0.03494|0.2606|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2606|0.03494|0.0108
71894439|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.64|||||TWO_SIDED|95.0|0.51|0.8||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.80|0.51|
71806338|NCT02479412|143114312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.857|STANDARD_ERROR_OF_MEAN|3.214||0.1342|TWO_SIDED|95.0|-11.24|1.528|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||1.528|-11.24|0.1342
71806339|NCT02479412|143114312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.41|STANDARD_ERROR_OF_MEAN|3.19||0.0016|TWO_SIDED|95.0|-16.75|-4.075|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.075|-16.75|0.0016
71806340|NCT02479412|143114312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.75|STANDARD_ERROR_OF_MEAN|3.236|<|0.0001|TWO_SIDED|95.0|-21.18|-8.319|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-8.319|-21.18|<0.0001
71806341|NCT02479412|143114313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.85|STANDARD_ERROR_OF_MEAN|5.139||0.0084|TWO_SIDED|95.0|-24.06|-3.642|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO||-3.642|-24.06|0.0084
71806342|NCT02479412|143114313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.26|STANDARD_ERROR_OF_MEAN|5.088||0.0062|TWO_SIDED|95.0|-24.37|-4.149|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO||-4.149|-24.37|0.0062
71806343|NCT02479412|143114313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.137||0.0002|TWO_SIDED|95.0|-30.1|-9.689|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO||-9.689|-30.10|0.0002
71806344|NCT02479412|143114314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03051|STANDARD_ERROR_OF_MEAN|0.05856||0.6036|TWO_SIDED|95.0|-0.08579|0.1468|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.1468|-0.08579|0.6036
71806345|NCT02479412|143114314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01744|STANDARD_ERROR_OF_MEAN|0.05869||0.767|TWO_SIDED|95.0|-0.09912|0.134|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1340|-0.09912|0.7670
71806346|NCT02479412|143114314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1561|STANDARD_ERROR_OF_MEAN|0.05874||0.0093|TWO_SIDED|95.0|0.03943|0.2728|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.2728|0.03943|0.0093
71806347|NCT02479412|143114315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03467|STANDARD_ERROR_OF_MEAN|0.05377||0.5207|TWO_SIDED|95.0|-0.1415|0.07213|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.07213|-0.1415|0.5207
71806348|NCT02479412|143114315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02821|STANDARD_ERROR_OF_MEAN|0.05336||0.5983|TWO_SIDED|95.0|-0.07778|0.1342|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1342|-0.07778|0.5983
71806349|NCT02479412|143114315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06169|STANDARD_ERROR_OF_MEAN|0.05371||0.2538|TWO_SIDED|95.0|-0.04501|0.1684|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1684|-0.04501|0.2538
71806350|NCT02479412|143114316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02262|STANDARD_ERROR_OF_MEAN|0.05743||0.6945|TWO_SIDED|95.0|-0.1367|0.09144|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.09144|-0.1367|0.6945
71806351|NCT02479412|143114316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.000314|STANDARD_ERROR_OF_MEAN|0.05755||0.9957|TWO_SIDED|95.0|-0.1146|0.114|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1140|-0.1146|0.9957
71806352|NCT02479412|143114316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06831|STANDARD_ERROR_OF_MEAN|0.05774||0.2398|TWO_SIDED|95.0|-0.04637|0.183|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||0.1830|-0.04637|0.2398
71806353|NCT02479412|143114317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.34|STANDARD_ERROR_OF_MEAN|5.877||0.0819|TWO_SIDED|95.0|-1.335|22.01|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||22.01|-1.335|0.0819
71806354|NCT02479412|143114317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.253|STANDARD_ERROR_OF_MEAN|5.881||0.3741|TWO_SIDED|95.0|-6.427|16.93|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||16.93|-6.427|0.3741
71806355|NCT02479412|143114317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|5.926||0.0374|TWO_SIDED|95.0|0.7481|24.29|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||24.29|0.7481|0.0374
71806356|NCT02479412|143114318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.73|STANDARD_ERROR_OF_MEAN|5.384||0.0044|TWO_SIDED|95.0|5.039|26.43|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||26.43|5.039|0.0044
71806357|NCT02479412|143114318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|5.419||0.0098|TWO_SIDED|95.0|3.534|25.06|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||25.06|3.534|0.0098
71806358|NCT02479412|143114318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.91|STANDARD_ERROR_OF_MEAN|5.459||0.0004|TWO_SIDED|95.0|9.068|30.75|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||30.75|9.068|0.0004
71806359|NCT02479412|143114319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3435|STANDARD_ERROR_OF_MEAN|0.189||0.0723|TWO_SIDED|95.0|-0.7189|0.03179|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.03179|-0.7189|0.0723
71806360|NCT02479412|143114319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4852|STANDARD_ERROR_OF_MEAN|0.1903||0.0124|TWO_SIDED|95.0|-0.8631|-0.1073|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||-0.1073|-0.8631|0.0124
71806361|NCT02479412|143114319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8026|STANDARD_ERROR_OF_MEAN|0.1914|<|0.0001|TWO_SIDED|95.0|-1.183|-0.4224|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4224|-1.183|<0.0001
71806362|NCT02479412|143114320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3071|STANDARD_ERROR_OF_MEAN|0.1051||0.0044|TWO_SIDED|95.0|-0.5159|-0.09836|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09836|-0.5159|0.0044
71806363|NCT02479412|143114320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1824|STANDARD_ERROR_OF_MEAN|0.1059||0.0883|TWO_SIDED|95.0|-0.3927|0.02789|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.02789|-0.3927|0.0883
71806364|NCT02479412|143114320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4301|STANDARD_ERROR_OF_MEAN|0.1055|<|0.0001|TWO_SIDED|95.0|-0.6397|-0.2205|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.2205|-0.6397|<0.0001
71806365|NCT02479412|143114321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1651|STANDARD_ERROR_OF_MEAN|0.09139||0.0741|TWO_SIDED|95.0|-0.3466|0.01638|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||0.01638|-0.3466|0.0741
71806366|NCT02479412|143114321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09079|STANDARD_ERROR_OF_MEAN|0.09204||0.3265|TWO_SIDED|95.0|-0.2736|0.09201|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.09201|-0.2736|0.3265
71806367|NCT02479412|143114321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2532|STANDARD_ERROR_OF_MEAN|0.09176||0.007|TWO_SIDED|95.0|-0.4354|-0.07092|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.07092|-0.4354|0.0070
71894440|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.66|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.12|0.66|
71806368|NCT02479412|143114322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4185|STANDARD_ERROR_OF_MEAN|0.1626||0.0116|TWO_SIDED|95.0|-0.7414|-0.09563|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.09563|-0.7414|0.0116
71806369|NCT02479412|143114322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1794|STANDARD_ERROR_OF_MEAN|0.1628||0.2732|TWO_SIDED|95.0|-0.5027|0.1438|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.1438|-0.5027|0.2732
71806370|NCT02479412|143114322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7661|STANDARD_ERROR_OF_MEAN|0.1636|<|0.0001|TWO_SIDED|95.0|-1.091|-0.4411|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.4411|-1.091|<0.0001
71806371|NCT02479412|143114323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1067|STANDARD_ERROR_OF_MEAN|0.04982||0.0349|TWO_SIDED|95.0|-0.2057|-0.007755|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||-0.007755|-0.2057|0.0349
71806372|NCT02479412|143114323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08205|STANDARD_ERROR_OF_MEAN|0.05015||0.1052|TWO_SIDED|95.0|-0.1817|0.01756|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||0.01756|-0.1817|0.1052
71806373|NCT02479412|143114323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2027|STANDARD_ERROR_OF_MEAN|0.05044||0.0001|TWO_SIDED|95.0|-0.3028|-0.1025|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||-0.1025|-0.3028|0.0001
71806374|NCT02479412|143114324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.673|STANDARD_ERROR_OF_MEAN|0.2946||0.0247|TWO_SIDED|95.0|0.08779|1.258|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO||1.258|0.08779|0.0247
71806375|NCT02479412|143114324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4281|STANDARD_ERROR_OF_MEAN|0.2965||0.1521|TWO_SIDED|95.0|-0.1607|1.017|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO||1.017|-0.1607|0.1521
71806376|NCT02479412|143114324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9415|STANDARD_ERROR_OF_MEAN|0.2987||0.0022|TWO_SIDED|95.0|0.3483|1.535|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO||1.535|0.3483|0.0022
71806377|NCT02479412|143114328|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|272.2|||<|0.0001|TWO_SIDED|90.0|237.43|312.05|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||312.05|237.43|<0.0001
71806378|NCT02479412|143114328|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|676.13|||<|0.0001|TWO_SIDED|90.0|580.91|786.95|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||786.95|580.91|<0.0001
71806379|NCT02479412|143114329|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|337.82|||<|0.0001|TWO_SIDED|90.0|290.8|392.43|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg||392.43|290.80|<0.0001
71806380|NCT02479412|143114329|SUPERIORITY_OR_OTHER||Ratio Estimate (%)|964.62|||<|0.0001|TWO_SIDED|90.0|816.13|1140.13|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg||1140.13|816.13|<0.0001
71806381|NCT04969250|143114346|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
71806382|NCT04969250|143114347|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.40
71806383|NCT04969250|143114348|SUPERIORITY|||||||0.078|||||||Fisher Exact|||||||0.078
71806384|NCT04969250|143114349|SUPERIORITY|||||||0.033|||||||Fisher Exact|||||||0.033
71806385|NCT01221597|143114351|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||ANOVA|||||||0.0005
71806386|NCT01221597|143114352|SUPERIORITY_OR_OTHER|||||||0.0451|TWO_SIDED||||||ANOVA|||||||0.0451
71806387|NCT01221597|143114353|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<.0001
71806388|NCT01221597|143114354|SUPERIORITY_OR_OTHER|||||||0.0268|TWO_SIDED||||||ANOVA|||||||0.0268
71806389|NCT01221597|143114355|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANOVA|||||||0.0800
71806390|NCT01221597|143114356|SUPERIORITY_OR_OTHER|||||||0.3085|TWO_SIDED||||||ANOVA|||||||0.3085
71806391|NCT01221597|143114357|SUPERIORITY_OR_OTHER|||||||0.6321|TWO_SIDED||||||ANOVA|||||||0.6321
71806392|NCT01221597|143114358|SUPERIORITY_OR_OTHER|||||||0.7965|TWO_SIDED||||||ANOVA|||||||0.7965
71806393|NCT01221597|143114359|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71806394|NCT01059565|143114396|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|0.91||||0.663|TWO_SIDED|95.0|-3.24|5.06||"To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|Baseline was included as a covariate in this model.||"The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.~A sample size of 50 participants per group provided at least 80% power to detect an 8.5% difference in mean AUCave of relative change from baseline in FEV1 % predicted through Week 24 using a two-sided 0.05-level test, assuming a common standard deviation of 15."||5.06|-3.24|0.663
71675894|NCT02549287|142869433|SUPERIORITY||Odds Ratio, log|-0.22||||0.47|TWO_SIDED|95.0|-0.76|0.32||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.32|-0.76|0.47
71894441|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||1.32|0.85|
71675895|NCT02549287|142869434|SUPERIORITY||Slope|-0.75||||0.65|TWO_SIDED|95.0|-3.7|2.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||2.20|-3.70|0.65
71675896|NCT02549287|142869435|SUPERIORITY||Odds Ratio, log|0.05||||0.64|TWO_SIDED|95.0|-0.59|0.69||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.69|-0.59|0.64
71894442|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.58|0.92||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.||0.92|0.58|
71894443|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.43|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.43|
71894444|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.77|1.2||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.20|0.77|
71894445|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.6|||||TWO_SIDED|95.0|0.41|0.87||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.41|
71894446|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.7|||||TWO_SIDED|95.0|0.56|0.88||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.56|
71894447|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.41|0.7||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.70|0.41|
71894448|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.71|1.03||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.71|
71894449|NCT01193335|143310978|SUPERIORITY_OR_OTHER||GMC Ratio|0.55|||||TWO_SIDED|95.0|0.42|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.42|
71894450|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.51|0.82||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.82|0.51|
71894451|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.47|0.79||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.47|
71894452|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.61|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.93|0.61|
71894453|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.07||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.66|
71894454|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.66|1.08||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.08|0.66|
71894455|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
71894456|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.46|0.79||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.79|0.46|
71894457|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.64|1.03||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.64|
71675897|NCT02549287|142869436|SUPERIORITY||Odds Ratio, log|-0.25||||0.44|TWO_SIDED|95.0|-0.79|0.29||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.29|-0.79|0.44
71675898|NCT02549287|142869437|SUPERIORITY||Odds Ratio, log|0.25||||0.47|TWO_SIDED|95.0|-0.39|0.89||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||0.89|-0.39|0.47
71675899|NCT02549287|142869438|SUPERIORITY||Slope|-0.18||||0.63|TWO_SIDED|95.0|-3.57|3.22||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.||3.22|-3.57|0.63
71675900|NCT00789698|142869481|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.|Hazard Ratio (HR)|0.728|||||TWO_SIDED|95.0|0.41|1.295||There is no hypothesis tested. Since this was a non-inferiority study, the upper bound of the 95% CI for the hazard ratio was compared to the pre-specified margin of 1.93 to demonstrate the non-inferiority of lurasidone compared to Quetiapine XR.|COX Proportional Hazards Model|||Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.||1.295|0.410|
71675901|NCT00869622|142869499|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||||||0.0229
71675902|NCT02986282|142869506|OTHER||Median Difference (Final Values)|-0.0600326|||<|0.05|TWO_SIDED|95.0|-0.0799661|-0.0449876|||Wilcoxon (Mann-Whitney)|||It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.||-0.0449876|-0.0799661|<0.05
71675903|NCT02986282|142869507|OTHER||Median Difference (Final Values)|-0.0249837|||<|0.05|TWO_SIDED|95.0|-0.039992|-0.0100226|||Wilcoxon (Mann-Whitney)|||||-0.0100226|-0.039992|<0.05
71806395|NCT01059565|143114397|SUPERIORITY_OR_OTHER|||||||0.4158||||||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|Negative binomial regression|The negative binomial regression model included an offset parameter which accounted for potential differing study durations due to discontinuations.||The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.4158
71675904|NCT00468481|142869531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|384.7|||<|0.0001||95.0|282.42|486.98|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate|Difference = DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.||486.98|282.42|<0.0001
71675905|NCT00468481|142869532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.87|||<|0.0001||95.0|14.04|23.7|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate|Difference =DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.||23.70|14.04|<0.0001
71675906|NCT00734162|142869595|SUPERIORITY_OR_OTHER||||||<|0.001||||||A p-value of \< 0.05 was considered statistically significant.|Cochran-Mantel-Haenszel|||Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.||||< 0.001
71675907|NCT00653133|142869632|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.||||<0.05
71675908|NCT01068730|142869636|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|102.58|||||TWO_SIDED|95.0|99.07|106.23|||||Ratio=Treatment B/Treatment A. Geometric least squares (LS) means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.23|99.07|
71675909|NCT01068730|142869636|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|99.67|||||TWO_SIDED|95.0|96.16|103.31|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.31|96.16|
71675910|NCT01068730|142869636|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7062.8||||||||||||||Geometric least squares means for Treatment A||||
71813594|NCT04858802|143129492|SUPERIORITY||Mean Difference (Final Values)|-51.98|STANDARD_DEVIATION|434.64||0.432|TWO_SIDED|95.0|-184.1|80.2||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSOT volume minus balloon sinus dilation alone mean FSOT volume|Day 180||80.2|-184.1|0.432
71813595|NCT04858802|143129493|SUPERIORITY||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|2.13||0.023|TWO_SIDED|95.0|0.1|1.4||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 45||1.4|0.1|0.023
71675911|NCT01068730|142869636|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7245.2||||||||||||||Geometric least squares means for Treatment B||||
71842470|NCT00450216|143196544|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8|||<|0.0001|TWO_SIDED|95.0|4.4|15.3||CMH test stratified by use of low-dose aspirin (yes/no) and prior upper gastrointestinal (UGI) ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The primary efficacy endpoint was the number of participants developing gastric ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 24 weeks. The cumulative number of participants developing gastric ulcers at 24 weeks was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by use of low-dose aspirin and prior UGI ulcer history.||15.3|4.4|<0.0001
71675912|NCT01068730|142869636|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11680.0||||||||||||||Geometric least squares means for Treatment C||||
71675913|NCT01068730|142869636|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)]|11641.0||||||95.0||||||||Geometric least squares means for Treatment D||||
71675914|NCT01068730|142869637|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|101.12|||||TWO_SIDED|95.0|96.36|106.11|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||106.11|96.36|
71675915|NCT01068730|142869637|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|98.65|||||TWO_SIDED|95.0|93.94|103.59|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||103.59|93.94|
71675916|NCT01068730|142869637|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1013.6||||||||||||||Geometric least squares means for Treatment A||||
71675917|NCT01068730|142869637|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1024.9||||||||||||||Geometric least squares means for Treatment B||||
71675918|NCT01068730|142869637|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1643.8||||||||||||||Geometric least squares means for Treatment C||||
71675919|NCT01068730|142869637|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng/mL)|1621.6||||||||||||||Geometric least squares means for Treatment D||||
71675920|NCT01068730|142869647|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|103.19|||||TWO_SIDED|95.0|99.75|106.75|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|||106.75|99.75|
71675921|NCT01068730|142869647|SUPERIORITY_OR_OTHER||Ratio (%) of Geometric LS Means|99.44|||||TWO_SIDED|95.0|96.08|102.92|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|||102.92|96.08|
71675922|NCT01068730|142869647|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|6907.1||||||||||||||Geometric least squares means for Treatment A||||
71675923|NCT01068730|142869647|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|7127.4||||||95.0||||||||Geometric least squares means for Treatment B||||
71675924|NCT01068730|142869647|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean (ng*hr/mL)|11391.0||||||||||||||Geometric least squares means for Treatment C||||
71675925|NCT01068730|142869647|SUPERIORITY_OR_OTHER||[Geometric Least Squares Mean (ng*hr/mL)|11327.0||||||||||||||Geometric least squares means for Treatment D||||
71806396|NCT01059565|143114398|SUPERIORITY_OR_OTHER||Difference in LSM|0.18||||0.939|TWO_SIDED|95.0|-4.43|1.78||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||1.78|-4.43|0.939
71806397|NCT01059565|143114399|SUPERIORITY_OR_OTHER||Difference in LSM|0.77||||0.711|TWO_SIDED|95.0|-3.33|4.86|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.86|-3.33|0.711
71675926|NCT05406479|142869657|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-5.146|4.76||||||Adults||4.76|-5.146|
71806398|NCT01059565|143114400|SUPERIORITY_OR_OTHER||Difference in LSM|0.6||||0.762|TWO_SIDED|95.0|-3.3|4.49|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||4.49|-3.30|0.762
71806399|NCT01059565|143114401|SUPERIORITY_OR_OTHER||Difference in LSM|1.95||||0.553|TWO_SIDED|95.0|-4.54|8.44|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.44|-4.54|0.553
71675927|NCT05406479|142869657|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|10.556|||||TWO_SIDED|95.0|0.926|20.185||||||Adolescents (13-17)||20.185|0.926|
71675928|NCT05406479|142869657|NON_INFERIORITY|For the hypothesis testing of non-inferiority the confidence interval should be compared to the non-inferiority margin. More specifically, non-inferiority is established if the upper limit of a one-sided 95% confidence interval around the difference in means QTc 24 hours after treatment administration (BE-PEP - SDR-PEP) is below the non-inferiority limit of +10 ms. A two-sample t-test was used to compare the two groups, but the p-value returned should not be used to conclude non-inferiority.|Mean Difference (Final Values)|2.076|||||TWO_SIDED|95.0|-3.374|7.525||||||Children (5-12)||7.525|-3.374|
71806400|NCT01059565|143114402|SUPERIORITY_OR_OTHER||Difference in LSM|2.99||||0.17|TWO_SIDED|95.0|-1.2|7.28|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||7.28|-1.20|0.170
71806401|NCT01059565|143114403|SUPERIORITY_OR_OTHER||Difference in LSM|-2.57||||0.528|TWO_SIDED|95.0|-10.62|5.49|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||5.49|-10.62|0.528
71806402|NCT01059565|143114404|SUPERIORITY_OR_OTHER||Difference in LSM|3.62||||0.132|TWO_SIDED|95.0|-1.11|8.34|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||8.34|-1.11|0.132
71806403|NCT01059565|143114405|SUPERIORITY_OR_OTHER||Difference in LSM|0.14||||0.531|TWO_SIDED|95.0|-0.29|0.56|||Mixed Models Analysis|P-value was based on a Mixed-Effect Model Repeated Measure model that included terms for treatment, visit, baseline, and treatment/visit interaction.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||0.56|-0.29|0.531
71806404|NCT01059565|143114406|SUPERIORITY_OR_OTHER||Difference in LSM|0.93||||0.232|TWO_SIDED|95.0|-0.62|2.48|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||2.48|-0.62|0.232
71806405|NCT01059565|143114407|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.103
71806406|NCT01059565|143114408|SUPERIORITY_OR_OTHER|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.646
71806407|NCT01059565|143114409|SUPERIORITY_OR_OTHER|||||||0.284|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.||||0.284
71806408|NCT00574587|143114411|SUPERIORITY_OR_OTHER_LEGACY||95% Confidence interval|54.0|||<|0.1|TWO_SIDED|20.0|34.0|74.0|||Simon's Mimimax 2-stage design|||||74|34|<0.10
71806409|NCT00845663|143114436|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|101.33||||||90.0|92.84|110.58|||ANOVA|ANOVA for log-transformed values with treatment as factor has been used as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||110.58|92.84|
71806410|NCT00845663|143114437|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125% bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.7||||||90.0|89.06|107.19|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as the basis for calculation of estimated value and confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||107.19|89.06|
71806411|NCT00845663|143114438|NON_INFERIORITY_OR_EQUIVALENCE|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.54||||||90.0|87.33|108.94|||ANOVA|ANOVA for log-transformed values with treatment as factor was taken as a basis for calculation of estimated value and the confidence interval.|Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval||108.94|87.33|
71806412|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806413|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806414|NCT05585307|143114523|SUPERIORITY|||||||0.0013||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||0.0013
71806415|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806416|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806417|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806418|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806419|NCT05585307|143114523|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806420|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806421|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806422|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71894458|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.73|1.15||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.73|
71894459|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.58|
71806423|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806424|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806425|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806426|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806427|NCT05585307|143114524|SUPERIORITY||||||<|0.0001||||||P-value was calculated from two-sided t-test.|t-test, 2 sided|||||||<0.0001
71806428|NCT04420221|143114570|SUPERIORITY||Vaccine Efficacy (VE)|-74.76||||0.8042||92.5|-680.61|36.62|||Log Rank|One-sided Group Sequential Design with non-binding beta, yielding two CIs based on cumulative alpha (92.5%) and beta (80.5%) spending|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||36.62|-680.61|0.8042
71806429|NCT04420221|143114571|OTHER||Vaccine Efficacy (VE)|-38.09|||||TWO_SIDED|95.0|-245.77|40.86|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||40.86|-245.77|
71806430|NCT04420221|143114572|OTHER||Vaccine Efficacy (VE)|-75.52|||||TWO_SIDED|95.0|-295.41|17.46|||||Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio times 100.|||17.46|-295.41|
71806431|NCT00511004|143114573|SUPERIORITY_OR_OTHER||||||<|0.2|TWO_SIDED|||||Adjusted for multiple comparisons|Fisher Exact|||||||<0.2
71806432|NCT00511004|143114574|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Fisher Exact|||||||0.9
71806433|NCT01581281|143114616|SUPERIORITY||Odds Ratio (OR)|0.71||||0.2636|TWO_SIDED|98.3|0.34|1.48||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons, the Bonferroni corrected level of significance is 0.017 (= 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for amitriptyline relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.48|0.34|0.2636
71806434|NCT01581281|143114616|SUPERIORITY||Odds Ratio (OR)|0.81||||0.4821|TWO_SIDED|98.3|0.39|1.68||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.68|0.39|0.4821
71894460|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.57|0.9||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.57|
71894461|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.00|0.69|
71894462|NCT01193335|143310979|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.49|0.81||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.49|
71894463|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.63|1.04||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.63|
71894464|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.63|||||TWO_SIDED|95.0|0.48|0.83||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.48|
71894465|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.62|||||TWO_SIDED|95.0|0.46|0.84||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.84|0.46|
71894466|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.61|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.12|0.61|
71842471|NCT00450216|143196545|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.8|||<|0.0001|TWO_SIDED|95.0|6.1|17.6||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing UGI (i.e., gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative number of participants developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history.||17.6|6.1|<0.0001
71842472|NCT00450216|143196546|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.0006|TWO_SIDED|95.0|1.0|6.8||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing duodenal ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative number of participants developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prio UGI ulcer history at randomization.||6.8|1.0|0.0006
71842473|NCT03735979|143196568|SUPERIORITY||Posterior Mean Difference (Final Values)|-1.51|STANDARD_DEVIATION|0.51||0.002|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that argatroban was better than placebo was 0.002."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.002
71842474|NCT03735979|143196568|SUPERIORITY||Posterior Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|0.29||0.04|TWO_SIDED|||||"The P-value is the posterior probability that study drug has a higher benefit than control. The a priori threshold for a successful trial is 0.985.~The posterior probability that eptifibitide was better than placebo was 0.04."|Bayesian|Primary analysis compared treatment group with placebo, with adjustment for baseline NIHSS score in a Bayesian normal dynamic linear model.|The posterior mean of study treatment minus placebo.|||||0.04
71842475|NCT05654662|143196593|SUPERIORITY|||||||0.0032|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||0.0032
71842476|NCT05654662|143196594|SUPERIORITY||Adjusted Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.03||0.0013|TWO_SIDED|95.0|-10.6|-2.6|||Mixed Model with Repeated Measure (MMRM)||Adjusted mean difference was calculated as test product minus reference product.|||-2.6|-10.6|0.0013
71842477|NCT05654662|143196595|SUPERIORITY|||||||0.0181|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||0.0181
71842478|NCT05654662|143196595|SUPERIORITY|||||||0.0541|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||0.0541
71842479|NCT05654662|143196596|SUPERIORITY||Adjusted Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.44||0.0091|TWO_SIDED|95.0|-6.7|-1.0|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-1.0|-6.7|0.0091
71842480|NCT05654662|143196596|SUPERIORITY||Adjusted Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.78||0.0031|TWO_SIDED|95.0|-8.8|-1.8|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-1.8|-8.8|0.0031
71842481|NCT05654662|143196597|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
71842482|NCT05654662|143196597|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
71842483|NCT05654662|143196597|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
71842484|NCT05654662|143196598|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.011||0.0051|TWO_SIDED|95.0|-0.05|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.01|-0.05|0.0051
71842485|NCT05654662|143196598|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.013||0.0034|TWO_SIDED|95.0|-0.07|-0.01|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.01|-0.07|0.0034
71842486|NCT05654662|143196598|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.015||0.0022|TWO_SIDED|95.0|-0.08|-0.02|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.02|-0.08|0.0022
71842487|NCT05654662|143196599|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
71842488|NCT05654662|143196599|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
71842489|NCT05654662|143196599|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
71842490|NCT05654662|143196600|SUPERIORITY||Adjusted Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|-0.12|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.04|-0.12|<0.0001
71842491|NCT05654662|143196600|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.07|-0.18|<0.0001
71842492|NCT05654662|143196600|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|-0.2|-0.08|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.08|-0.20|<0.0001
71842493|NCT05654662|143196601|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
71842494|NCT05654662|143196601|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
71842495|NCT05654662|143196601|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
71842496|NCT05654662|143196602|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.0012|TWO_SIDED|95.0|-0.25|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.25|0.0012
71842497|NCT05654662|143196602|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.061||0.0058|TWO_SIDED|95.0|-0.29|-0.05|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.05|-0.29|0.0058
71842498|NCT05654662|143196602|SUPERIORITY||Adjusted Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.42|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.42|<0.0001
71894467|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.5|||||TWO_SIDED|95.0|0.37|0.67||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.67|0.37|
71806435|NCT01581281|143114616|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6107|TWO_SIDED|98.3|0.49|1.59||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||"Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to amitriptyline. The analyses followed the intention to treat principle, imputing an outcome of failure for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days)."||1.59|0.49|0.6107
71894468|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.4|0.72||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.40|
71894469|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.47|||||TWO_SIDED|95.0|0.35|0.64||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.64|0.35|
71675929|NCT03567005|142869662|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).|Least Squares Mean (LSM) Difference|0.0|STANDARD_ERROR_OF_MEAN|0.008|||ONE_SIDED|95.0||0.02||||||||0.02||
71675930|NCT03567005|142869663|NON_INFERIORITY|The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).|LSM Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15|||ONE_SIDED|95.0|-0.3||||||||||-0.3|
71842499|NCT05654662|143196603|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 3 (Test for non-zero within group change from Baseline)||||<0.0001
71842500|NCT05654662|143196603|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 6 (Test for non-zero within group change from Baseline)||||<0.0001
71842501|NCT05654662|143196603|SUPERIORITY||||||<|0.0001|||||||MMRM|||Change from Baseline at Week 12 (Test for non-zero within group change from Baseline)||||<0.0001
71842502|NCT05654662|143196604|SUPERIORITY||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.051||0.0022|TWO_SIDED|95.0|-0.26|-0.06|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 3||-0.06|-0.26|0.0022
71894470|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.76|||||TWO_SIDED|95.0|0.61|0.94||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.61|
71894471|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.59|||||TWO_SIDED|95.0|0.39|0.9||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.90|0.39|
71842503|NCT05654662|143196604|SUPERIORITY||Adjusted Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0099|TWO_SIDED|95.0|-0.3|-0.04|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 6||-0.04|-0.30|0.0099
71842504|NCT05654662|143196604|SUPERIORITY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.073|<|0.0001|TWO_SIDED|95.0|-0.45|-0.16|||MMRM||Adjusted mean difference was calculated as test product minus reference product.|Change from Baseline at Week 12||-0.16|-0.45|<0.0001
71894472|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.52|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.52|
71842505|NCT04499521|143196629|OTHER||Median Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.27|0.5||||||Mean difference between Gauze and Gel ARM A Bladder D2cc||0.50|-0.27|
71675931|NCT01057810|142869664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.3667|TWO_SIDED|95.87|0.88|1.39|||Log Rank||Hazard ratio = ipilimumab over placebo|||1.39|0.88|0.3667
71675932|NCT01057810|142869665|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.55|0.8|||||HR = ipilimumab over placebo|||0.80|0.55|
71675933|NCT01057810|142869666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.87|0.52|0.83|||||HR = Ipilimumab over placebo|||0.83|0.52|
71675934|NCT01057810|142869667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.87|0.71|1.35|||||HR = Ipilimumab over placebo|||1.35|0.71|
71675935|NCT00379080|142869701|OTHER|||||||0.04|||||||Regression, Cox|||VEGFR2||||0.04
71675936|NCT00379080|142869701|OTHER|||||||0.04|||||||Regression, Cox|||PIGF||||0.04
71675937|NCT00379080|142869701|OTHER|||||||0.02|||||||Regression, Cox|||CAIX||||0.02
71806436|NCT01581281|143114617|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.9137|TWO_SIDED|95.0|-6.64|5.95|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||5.95|-6.64|0.9137
71806437|NCT01581281|143114617|SUPERIORITY||Median Difference (Final Values)|-4.84||||0.1331|TWO_SIDED|95.0|-11.16|1.49|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.49|-11.16|0.1331
71842506|NCT04499521|143196629|OTHER||Median Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||Mean difference between Gauze and Gel ARM B Bladder D2cc||0.96|-0.94|
71842507|NCT04499521|143196629|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.54|0.16||||||Mean difference between Gauze and Gel ARM A Rectum D2cc||0.16|-0.54|
71675938|NCT00379080|142869701|OTHER|||||||0.05|||||||Regression, Cox|||sFLT\_1||||0.05
71675939|NCT00379080|142869701|OTHER|||||||0.01|||||||Regression, Cox|||sFLT\_1||||0.01
71675940|NCT00379080|142869701|OTHER|||||||0.05|||||||Regression, Cox|||VEGFR2||||0.05
71675941|NCT02901067|142869703|SUPERIORITY|This is a secondary outcome thus no power analysis was done.|||||>|0.05|||||||Fisher Exact|||We hypothesized that the experimental group would present less fibrinolysis shutdown than the control group in all times measured.||||>0.05
71675942|NCT02901067|142869708|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71675943|NCT02901067|142869711|SUPERIORITY|||||||0.1|||||||Fisher Exact|||We hypothesized that the experimental group would have less pulmonary embolism events than the control group.||||0.10
71675944|NCT02901067|142869712|SUPERIORITY|||||||0.046|||||||Fisher Exact|||We hypothesized that the experimental group would have a lower incidence of venous thromboembolism (VTE) than the control group.||||0.046
71675945|NCT01222520|142869743|SUPERIORITY_OR_OTHER||Least square mean difference|9.14|||<|0.0001||95.0|7.09|11.18|||ANCOVA|||||11.18|7.09|<0.0001
71675946|NCT01222520|142869744|SUPERIORITY_OR_OTHER||Least square mean difference|14.88|||<|0.0001||95.0|11.82|17.94|||ANCOVA|||||17.94|11.82|<0.0001
71675947|NCT01222520|142869745|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71675948|NCT01222520|142869746|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71675949|NCT01222520|142869747|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71675950|NCT01222520|142869748|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71675951|NCT01222520|142869749|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71675952|NCT01089608|142869755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.01||||0.072|TWO_SIDED|95.0|-16.3|0.28|||Mixed Models Analysis|||||0.28|-16.30|0.072
71675953|NCT00497289|142869767|SUPERIORITY|||||||0.3654|||||||Wilcoxon (Mann-Whitney)|||||||0.3654
71675954|NCT00497289|142869768|SUPERIORITY|||||||0.0264|||||||Wilcoxon (Mann-Whitney)|||||||0.0264
71806438|NCT01581281|143114617|SUPERIORITY||Mean Difference (Final Values)|4.49||||0.1011|TWO_SIDED|95.0|-0.88|9.87|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||9.87|-0.88|0.1011
71813596|NCT04858802|143129493|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|2.24||0.646|TWO_SIDED|95.0|-0.8|0.5||Paired; the threshold for statistical significance was p = 0.05.|t-test, 2 sided||Difference = PROPEL Contour Sinus Implant mean FSO minimum diameter minus balloon sinus dilation alone mean FSO minimum diameter|Day 180||0.5|-0.8|0.646
71813597|NCT02026232|143129494|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71813598|NCT01529008|143129496|SUPERIORITY||Proportion treatment responder Differenc|-0.08||||0.539|TWO_SIDED|95.0|-0.35|0.18|||Fisher Exact||"Percentage of treatment responders in PREOB® group is 60.9% ((14/23)\*100), compared with 69.2% ((18/26)\*100) in Placebo.~Difference in percentage is -8.3 Difference in treatment responders proportion: PREOB® (0.609) - Placebo (0.692) = -0.08"|||0.18|-0.35|0.539
71813599|NCT02305381|143129497|SUPERIORITY_OR_OTHER||Treatment difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.01|-1.5|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.50|-2.01|< 0.0001
71675955|NCT00955955|142869769|SUPERIORITY_OR_OTHER||Mean Score Reduction|-5.6|STANDARD_DEVIATION|5.7||0.05||95.0|||||SPCD|Sequential Parallel Comparison Design (SPCD)|These results reflect the mean score reduction for the pooled Deplin sample.|Hypothesis 1: There will be a statistically significant difference between the two groups in the degree of improvement, as measured by the change in the 17-item Hamilton Depression Rating Scale (HAM-D-17) score from baseline to endpoint, using the sequential parallel comparison design \[51\]; with a greater degree of reduction in HAM-D-17 scores in the 6(S)-5-MTHF 15 mg qd group than in the placebo group, with the change on placebo being estimated from Trials 1 and 2.||||.05
71675956|NCT03169881|142869771|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.88|TWO_SIDED|95.0|-3.09|2.64||The mean difference in Bayley-III cognitive scores between treatment groups was adjusted for center, gestational age group, and familial clustering.|Mixed Models Analysis||Adjusted mean difference in cognitive score for the Darbepoetin minus Placebo treatment groups.|Null hypothesis: Weekly administration of Darbepoetin during the neonatal period will not impact neurocognitive outcomes at 22-26 months compared to Placebo in premature infants 23 to 28 weeks gestation.||2.64|-3.09|0.88
71675957|NCT03852264|142869785|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|2.61|||||TWO_SIDED|90.0|-1.29|6.38|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||6.38|-1.29|
71675958|NCT03852264|142869785|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|1.62|||||TWO_SIDED|90.0|-2.18|5.45|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||5.45|-2.18|
71675959|NCT03852264|142869785|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-4.93|2.83|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||2.83|-4.93|
71675960|NCT03852264|142869786|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.3482|||||TWO_SIDED|90.0|-0.476|1.211|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||1.211|-0.476|
71675961|NCT03852264|142869786|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.0635|||||TWO_SIDED|90.0|-0.931|0.803|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.803|-0.931|
71675962|NCT03852264|142869786|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-0.422|||||TWO_SIDED|90.0|-1.319|0.445|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||0.445|-1.319|
71675963|NCT03852264|142869787|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|0.468|||||TWO_SIDED|90.0|-101.0|99.5|||||Contrast reflecting Pet Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||99.5|-101|
71675964|NCT03852264|142869787|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.0|||||TWO_SIDED|90.0|-225.0|-15.5|||||Contrast reflecting Unfamiliar Dog Interaction - Toys Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-15.5|-225|
71806439|NCT01581281|143114618|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.3553|TWO_SIDED|98.3|-2.59|1.15||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.15|-2.59|0.3553
71675965|NCT03852264|142869787|OTHER|90% credible interval for contrast between conditions|Mean Difference (Net)|-115.48|||||TWO_SIDED|90.0|-223.0|-16.2|||||Contrast reflecting Unfamiliar Dog Interaction - Pet Dog Interaction|Bayesian multilevel model of area under the curve with respect to initial value (AUCi) as a function of experimental condition.||-16.2|-223|
71675966|NCT00637000|142869792|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|The statistical method used was a group by time repeated measures model with a first-order autoregressive covariance structure||To test the primary study hypothesis that neither soluble film formulation would precipitate an opioid withdrawal syndrome, peak COWS score in the 23.5 hour period after the initial soluble film administration were compared to pre-administration baseline COWS scores (30 minutes prior to soluble film administration) using a group by time repeated measures model with a first-order autoregressive covariance structure.||||<0.0001
71675967|NCT00637000|142869793|SUPERIORITY_OR_OTHER|||||||0|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.000
71675968|NCT00637000|142869794|SUPERIORITY_OR_OTHER|||||||0.035||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.035
71675969|NCT00637000|142869795|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71675970|NCT00637000|142869796|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71675971|NCT00637000|142869797|SUPERIORITY_OR_OTHER|||||||0.006||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.006
71675972|NCT00637000|142869798|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71842508|NCT04499521|143196629|OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.67|0.29||||||Mean difference between Gauze and Gel ARM B Rectum D2cc||0.29|-0.67|
71675973|NCT00637000|142869799|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71806440|NCT01581281|143114618|SUPERIORITY||Median Difference (Final Values)|-0.64||||0.4143|TWO_SIDED|98.3|-2.52|1.24||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.24|-2.52|0.4143
71806441|NCT01581281|143114618|SUPERIORITY||Median Difference (Final Values)|-0.08||||0.9038|TWO_SIDED|98.3|-1.68|1.52||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).||1.52|-1.68|0.9038
71806442|NCT01581281|143114619|SUPERIORITY||Odds Ratio (OR)|2.07||||0.1557|TWO_SIDED|95.0|0.85|5.05|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.05|0.85|0.1557
71806443|NCT01581281|143114619|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0754|TWO_SIDED|95.0|0.95|5.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||5.62|0.95|0.0754
71806444|NCT01581281|143114619|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7611|TWO_SIDED|95.0|0.49|1.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.||1.62|0.49|0.7611
71806445|NCT01581281|143114620|SUPERIORITY|||||||0.3038|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.3038
71806446|NCT01581281|143114620|SUPERIORITY|||||||1|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||1.000
71806447|NCT01581281|143114620|SUPERIORITY|||||||0.2139|||||||Fisher Exact|||The occurrence of treatment-related SAE's was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS's across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.||||0.2139
71806448|NCT04773587|143114643|SUPERIORITY||Odds Ratio (OR)|2.96|||<|0.0001|TWO_SIDED|95.0|1.881|4.647|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.647|1.881|<0.0001
71806449|NCT04773587|143114644|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.0001|TWO_SIDED|95.0|1.64|4.359|||Cochran-Mantel-Haenszel|Stratified by pooled study site with multiple imputation of missing observations|Stratified by pooled study site with multiple imputation of missing observations|Difference in vIGA-AD Success at Week 4||4.359|1.640|<0.0001
71806450|NCT04773587|143114645|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0089|TWO_SIDED|95.0|1.186|3.319|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 4||3.319|1.186|0.0089
71806451|NCT04773587|143114646|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0016|TWO_SIDED|95.0|1.45|5.457|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 2||5.457|1.450|0.0016
71806452|NCT04773587|143114647|SUPERIORITY||Odds Ratio (OR)|3.81||||0.0159|TWO_SIDED|95.0|1.161|12.511|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|WI-NRS Success at Week 1||12.511|1.161|0.0159
71675974|NCT00637000|142869800|SUPERIORITY_OR_OTHER|||||||0.762||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.762
71675975|NCT00637000|142869801|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71675976|NCT00637000|142869802|SUPERIORITY_OR_OTHER|||||||0.349||||||The p-value is not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.349
71675977|NCT00637000|142869803|SUPERIORITY_OR_OTHER|||||||0.028||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.028
71675978|NCT00637000|142869804|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71675979|NCT00637000|142869805|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71675980|NCT00637000|142869806|SUPERIORITY_OR_OTHER|||||||0.117||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.117
71675981|NCT00637000|142869807|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||<0.0001
71675982|NCT00637000|142869808|SUPERIORITY_OR_OTHER|||||||0.238||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.||||||0.238
71806453|NCT04773587|143114648|SUPERIORITY||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|2.102|4.795|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|EASI-75 at Week 4||4.795|2.102|<0.0001
71806454|NCT04773587|143114649|SUPERIORITY||Odds Ratio (OR)|2.56|||<|0.0001|TWO_SIDED|95.0|1.707|3.843|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study stie and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4||3.843|1.707|<0.0001
71675983|NCT04431908|142869815|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|89.35|||||TWO_SIDED|||||||||||||
71675984|NCT04431908|142869815|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|42.55|||||TWO_SIDED|||||||||||||
71675985|NCT04431908|142869815|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|87.24|||||TWO_SIDED|||||||||||||
71675986|NCT04431908|142869817|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Specificity|88.73|||||TWO_SIDED|||||||||||||
71806455|NCT04773587|143114650|SUPERIORITY||Odds Ratio (OR)|4.28|||<|0.0001|TWO_SIDED|95.0|2.31|7.926|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 2||7.926|2.310|<0.0001
71894473|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
71675987|NCT04431908|142869817|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Sensitivity|33.33|||||TWO_SIDED|||||||||||||
71675988|NCT04431908|142869817|OTHER|Sensitivity, specificity and accuracy was measured utilizing the true and false positives, as well as the true and false negatives. For a subject to have a true positive, the subject must have had a positive PCR test for COVID-19 as well as scored 0, 1 or 2 correct answers on the smell test. For a subject to have a true negative, the subject must have had a negative PCR test for COVID-19 as well as scored 3, 4 or 5 correct answers on the smell test.|Accuracy|88.13|||||TWO_SIDED|||||||||||||
71675989|NCT03425396|142869870|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.5|||||TWO_SIDED|95.0|-16.8|9.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.6|-16.8|
71675990|NCT03425396|142869870|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.0|||||TWO_SIDED|95.0|-27.4|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-27.4|
71675991|NCT03425396|142869870|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.6|||||TWO_SIDED|95.0|-19.6|7.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.4|-19.6|
71675992|NCT03425396|142869870|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
71675993|NCT03425396|142869871|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.6|||||TWO_SIDED|95.0|-14.3|11.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.2|-14.3|
71675994|NCT03425396|142869871|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.7|||||TWO_SIDED|95.0|-16.8|9.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.0|-16.8|
71675995|NCT03425396|142869871|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.3|12.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.3|-12.3|
71675996|NCT03425396|142869871|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
71675997|NCT03425396|142869872|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.0|||||TWO_SIDED|95.0|-22.5|16.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||16.8|-22.5|
71806456|NCT04773587|143114651|SUPERIORITY||Odds Ratio (OR)|25.41|||<|0.0001|TWO_SIDED|95.0|2.815|229.388|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Success at Week 1||229.388|2.815|<0.0001
71806457|NCT04773587|143114652|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.0001|TWO_SIDED|95.0|2.217|5.911|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2||5.911|2.217|<0.0001
71806458|NCT04773587|143114653|SUPERIORITY||Odds Ratio (OR)|3.46||||0.0002|TWO_SIDED|95.0|1.705|7.007|||Cochran-Mantel-Haenszel|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|Stratified by pooled study site and vIGA-AD randomization strata with multiple imputation of missing observations|vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1||7.007|1.705|0.0002
71675998|NCT03425396|142869872|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-4.7|||||TWO_SIDED|95.0|-23.3|14.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.2|-23.3|
71675999|NCT03425396|142869872|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|5.7|||||TWO_SIDED|95.0|-13.0|22.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||22.6|-13.0|
71676000|NCT03425396|142869872|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
71676001|NCT03425396|142869873|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.7|||||TWO_SIDED|95.0|-10.0|13.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.4|-10.0|
71676002|NCT03425396|142869873|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-2.9|||||TWO_SIDED|95.0|-16.2|9.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||9.7|-16.2|
71676003|NCT03425396|142869873|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment Difference|7.7|||||TWO_SIDED|95.0|-0.3|18.5|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||18.5|-0.3|
71806459|NCT01808313|143114654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.59|||<|0.001|TWO_SIDED|95.0|42.53|64.66|||t-test, 2 sided|||||64.66|42.53|<0.001
71806460|NCT01808313|143114655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.36|||<|0.001|TWO_SIDED|95.0|48.72|80.0|||t-test, 2 sided|||||80.00|48.72|<0.001
71806461|NCT01808313|143114657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon signed-rank test|||Week 12||||<0.001
71806462|NCT01808313|143114657|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon signed-rank test|||Week 24||||0.003
71806463|NCT01808313|143114658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.366|0.519|||Wilcoxon signed-rank test||Week 12|||0.519|0.366|<0.001
71806464|NCT01808313|143114658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|||<|0.001|TWO_SIDED|95.0|0.303|0.453|||Wilcoxon signed-rank test||Week 24|||0.453|0.303|<0.001
71676004|NCT03425396|142869873|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatm,ent difference|7.7|||||TWO_SIDED|95.0|-34.9|20.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.6|-34.9|
71676005|NCT03425396|142869874|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|0.0|||||TWO_SIDED|95.0|-12.6|12.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.6|-12.6|
71676006|NCT03425396|142869874|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.7|||||TWO_SIDED|95.0|-16.3|10.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||10.2|-16.3|
71676007|NCT03425396|142869874|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.0|||||TWO_SIDED|95.0|-4.5|17.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||17.7|-4.5|
71676008|NCT03425396|142869874|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
71676009|NCT03425396|142869875|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.3|-27.3|
71806465|NCT00622167|143114679|SUPERIORITY_OR_OTHER|||||||0||0.0|||||Not done|||Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.||||0
71806466|NCT00765193|143114798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.01||95.0|2.12|2.62|||Regression, Logistic|||The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSE||2.62|2.12|<0.01
71806467|NCT04370054|143114815|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-3.49|||=|0.004|TWO_SIDED|95.0|-6.06|-0.91||One-sided p-value is reported.|Generalized linear model (GLM)||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-0.91|-6.06|=0.0040
71806468|NCT04370054|143114816|SUPERIORITY||||||=|0.0086||||||One-sided p-value is reported.|One-sided exact binomial proportion test|||||||=0.0086
71676010|NCT03425396|142869875|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.6|||||TWO_SIDED|95.0|-29.2|8.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||8.6|-29.2|
71676011|NCT03425396|142869875|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|1.3|||||TWO_SIDED|95.0|-19.0|19.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.2|-19.0|
71676012|NCT03425396|142869875|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||28.9|-40.4|
71806469|NCT04370054|143114817|NON_INFERIORITY|A repeated measures negative binomial regression model was used to test non-inferiority with non-inferiority margin = 3 bleeds/year at the one-sided alpha level = 0.025.|Mean Difference (Final Values)|-4.01|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.45||One-sided p-value is reported.|Repeated measures GLM||Difference in mean = Mean PF-07055480 Total ABR - Mean FVIII Prophylaxis Total ABR.|A repeated measures GLM was used with bleeds as dependent variable in negative binomial distribution, an interaction of duration by treatment, and 'participant' as random and treatment \& duration of follow-up as fixed effect.||-2.45|-5.57|<0.0001
71806470|NCT04370054|143114818|SUPERIORITY||Mean Difference (Final Values)|-124.18|||<|0.0001|TWO_SIDED|95.0|-139.47|108.89||One-sided p-value is reported.|Paired t-test||Treatment Difference = (PF-07055480 AIR - FVIII Prophylaxis AIR).|||108.89|-139.47|<0.0001
71676013|NCT03425396|142869876|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.3|||||TWO_SIDED|95.0|-18.6|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-18.6|
71806471|NCT04370054|143114820|SUPERIORITY||Mean Difference (Final Values)|-4076.06|||<|0.0001|TWO_SIDED|95.0|-4728.3|-3423.8||One-sided p-value is reported.|Paired t-test||Treatment Difference (FVIII Consumption post-IP Infusion - FVIII Consumption during FVIII Prophylaxis).|||-3423.8|-4728.3|<0.0001
71894474|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.67|1.02||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.02|0.67|
71894475|NCT01193335|143310980|SUPERIORITY_OR_OTHER||GMC Ratio|0.51|||||TWO_SIDED|95.0|0.36|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.72|0.36|
71894476|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.61|1.03||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.61|
71894477|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.38|0.76||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.38|
71894478|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.54|1.03||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.54|
71894479|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.51|1.17||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.51|
71894480|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.4|0.78||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.40|
71842509|NCT01385202|143196647|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|70.2|||<|0.0001|TWO_SIDED|95.0|60.9|78.4||In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.|Fisher Exact|The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p\<0.0001).|The confidence intervals above are the 95% exact binomial confidence intervals.|The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.||78.4|60.9|<0.0001
71676014|NCT03425396|142869876|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.8|||||TWO_SIDED|95.0|-29.6|-0.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-0.6|-29.6|
71676015|NCT03425396|142869876|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.3|||||TWO_SIDED|95.0|-23.2|4.4|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.4|-23.2|
71806472|NCT04953390|143114878|OTHER|||||||0.004|||||||ANOVA|||||||0.004
71806473|NCT04953390|143114879|OTHER|||||||0.029|||||||ANOVA|||||||.029
71806474|NCT04953390|143114880|OTHER|||||||0.0002|||||||ANOVA|||||||0.0002
71842510|NCT01385202|143196647|SUPERIORITY_OR_OTHER_LEGACY||Primary effectiveness rate|74.0|||||TWO_SIDED|95.0|66.0|82.0|||||The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.|||82|66|
71842511|NCT03334695|143196680|SUPERIORITY|||||||0.012|||||||Wilcoxon Rank Sum test|||||||0.012
71842512|NCT03969563|143196749|EQUIVALENCE|Equivalence based on non-significant difference between MBSR and Brain Health groups.|Mean Difference (Final Values)|0.3||||0.694|TWO_SIDED||||||Mixed Models Analysis|||||||.694
71806475|NCT04953390|143114881|OTHER|||||||0.14|||||||t-test, 2 sided|T-test done on DIR2 and DIR3 results only, as the conditions were equal for these two settings. DIR1 was tested in a different condition.||All three DIR settings were tested, but only the DIR2 and DIR3 were compared in t-test. This is because DIR1 mic setting was tested in a different condition (i.e. softer noise).||||.14
71842513|NCT03969563|143196750|EQUIVALENCE|Equivalence based on non-significant difference between MBSR vs Brain Health group.|Mean Difference (Final Values)|-1.4||||0.837|TWO_SIDED||||||Mixed Models Analysis|||||||.837
71842514|NCT01474122|143196751|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.194||||0.434|TWO_SIDED|95.0|0.766|1.861|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 3 mg and in placebo|||1.861|0.766|0.434
71842515|NCT01474122|143196751|SUPERIORITY_OR_OTHER_LEGACY||NB-2 estimate of new DUs per patient|1.208||||0.407|TWO_SIDED|95.0|0.773|1.886|||NB-2||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 10 mg and in placebo|||1.886|0.773|0.407
71842516|NCT01474122|143196752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.831||||0.5668|TWO_SIDED|95.0|0.442|1.564|||Chi-squared|||||1.564|0.442|0.5668
71806476|NCT04953390|143114884|OTHER|||||||0.0003|||||||ANOVA|||||||.0003
71806477|NCT05912400|143114885|OTHER||||||<|0.01||||||Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).|Spearman's Rho|||||||<0.01
71806478|NCT05912400|143114885|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
71842517|NCT01474122|143196752|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.789||||0.4624|TWO_SIDED|95.0|0.42|1.484|||Chi-squared|||||1.484|0.420|0.4624
71894481|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.45|||||TWO_SIDED|95.0|0.29|0.71||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.71|0.29|
71894482|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.56|||||TWO_SIDED|95.0|0.38|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.83|0.38|
71676016|NCT03425396|142869876|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.2|||||TWO_SIDED|95.0|-44.1|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-44.1|
71806479|NCT05912400|143114885|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
71806480|NCT05912400|143114885|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index)||||||0.88
71806481|NCT05912400|143114885|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
71806482|NCT05912400|143114886|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation btwn ECAR (Extracellular Acidification Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain)||||||0.54
71806483|NCT05912400|143114886|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
71806484|NCT05912400|143114886|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
71842518|NCT01474122|143196753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.216||||0.6117|TWO_SIDED|95.0|0.572|2.582|||Chi-squared|||||2.582|0.572|0.6117
71806485|NCT05912400|143114886|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
71806486|NCT05912400|143114886|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
71806487|NCT05912400|143114887|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and vitamin D levels.||||||0.36
71806488|NCT05912400|143114887|OTHER|||||||0.51|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between ECAR (Extracellular Acidification Rate) and vitamin D levels.||||||0.51
71806489|NCT05912400|143114888|OTHER||||||<|0.01|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||<0.01
71806490|NCT05912400|143114888|OTHER|||||||0.54|||||||Spearman's Rho|Spearman's rho used analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Current (Numeric Pain Rating Scale for current pain).||||||0.54
71806491|NCT05912400|143114889|OTHER|||||||0.02|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.02
71806492|NCT05912400|143114889|OTHER|||||||0.36|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) and NRS-11 Best (Numeric Pain Rating Scale for best pain).||||||0.36
71806493|NCT05912400|143114890|OTHER|||||||0.03|||||||Spearman's Rho|Spearman's rho was used to analyze correlation between OCR (Oxygen Consumption Rate) and NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.03
71806494|NCT05912400|143114890|OTHER|||||||0.94|||||||Spearman's Rho|Spearman's rho used to analyze correlation between ECAR (Extracellular Acidification Rate) \& NRS-11 Worst (Numeric Pain Rating Scale for worst pain).||||||0.94
71806495|NCT05912400|143114891|OTHER|||||||0.88|||||||Spearman's Rho|Correlation: OCR (Oxygen Consumption Rate) and FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.88
71806496|NCT05912400|143114891|OTHER|||||||0.53|||||||Spearman's Rho|Correlation: ECAR (Extracellular Acidification Rate) \& FACIT-F TOI (Functional Assessment of Chronic Illness Therapy - Fatigue, Trial Outcome Index).||||||0.53
71806497|NCT03248739|143114894|EQUIVALENCE|Based on occlusion data from the previously referenced prospective study, as well as a P-value of 0.05 and power of 0.80, the study will need to include 90 patients to demonstrate statistical significance. To ensure that power is adequate, we will plan to enroll 120 patients (60 in each arm).||||||0.23|||||||Fisher Exact|||||||0.23
71806498|NCT03214367|143114913|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|-0.08||||0.06|TWO_SIDED|95.0|-0.16|0.0|||Mixed Models Analysis|||||0.00|-0.16|0.060
71806499|NCT03214367|143114913|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.13||||0.003|TWO_SIDED|95.0|0.04|0.22|||Mixed Models Analysis|||||0.22|0.04|0.003
71806500|NCT03214367|143114914|SUPERIORITY||LS Mean Difference|-27.9|||<|0.001|TWO_SIDED|95.0|-35.3|-20.6|||ANCOVA|||||-20.6|-35.3|<0.001
71806501|NCT03214367|143114914|SUPERIORITY||LS Mean Difference|13.2||||0.002|TWO_SIDED|95.0|5.0|21.4|||ANCOVA|||||21.4|5.0|0.002
71806502|NCT03214367|143114915|SUPERIORITY||LS Mean Difference|-31.2|||<|0.001|TWO_SIDED|95.0|-41.1|-21.2|||ANCOVA|||||-21.2|-41.1|<0.001
71806503|NCT03214367|143114915|SUPERIORITY||LS Mean Difference|-6.7||||0.235|TWO_SIDED|95.0|-17.6|4.3|||ANCOVA|||||4.3|-17.6|0.235
71806504|NCT03214367|143114924|SUPERIORITY||LS Mean Difference|-0.06||||0.184|TWO_SIDED|95.0|-0.16|0.03|||Mixed Models Analysis|||||0.03|-0.16|0.184
71806505|NCT03508843|143114925|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
71806506|NCT03508843|143114926|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<.001
71806507|NCT03508843|143114927|SUPERIORITY||||||>|0.05|||||||McNemar|||||||>.05
71806508|NCT00765843|143114928|SUPERIORITY_OR_OTHER|||||||0.78|||||||ANOVA|||baseline comparisons||||0.78
71806509|NCT00765843|143114928|SUPERIORITY_OR_OTHER|||||||0.21|||||||ANOVA|||one month comparisons||||0.21
71806510|NCT00765843|143114928|SUPERIORITY_OR_OTHER|||||||0.93|||||||ANOVA|||three months comparisons||||0.93
71806511|NCT03555396|143114929|SUPERIORITY||Mean Difference (Final Values)|-3.54||||0.483|TWO_SIDED|95.0|-13.53|6.46|||t-test, 2 sided|||||6.46|-13.53|0.483
71806512|NCT03555396|143114930|SUPERIORITY|||||||0.637|||||||Chi-squared|||||||0.637
71806513|NCT03555396|143114931|SUPERIORITY||Mean Difference (Net)|9.54||||0.037|TWO_SIDED|95.0|0.59|18.49||Difference in mean change in adherence from baseline to 6 month follow-up between individuals in the intervention and control arms.|Mixed Models Analysis|Multilevel linear mixed model with random effects (dyad \& intercept); adjusting for participant age, sex, baseline adherence, and partner HIV status||||18.49|0.59|0.037
71842519|NCT01474122|143196753|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.048||||0.9047|TWO_SIDED|95.0|0.485|2.264|||Chi-squared|||||2.264|0.485|0.9047
71842520|NCT01474122|143196754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.347|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.347
71806514|NCT03555396|143114932|SUPERIORITY|||||||0.621|||||||Chi-squared|Fisher's Exact Test used for small sample sizes||||||0.621
71806515|NCT04256733|143114933|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||||||.23
71806516|NCT04256733|143114934|SUPERIORITY|||||||0.57|||||||Mixed Models Analysis|||||||.57
71806517|NCT04256733|143114935|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71806518|NCT04542343|143114936|OTHER||Mean Difference (Net)|3.0|||<|0.01|TWO_SIDED|95.0|2.246|3.754|||t-test, 2 sided|||||3.75400|2.24600|<0.01
71806519|NCT04542343|143114937|OTHER||Mean Difference (Net)|-3.3|||<|0.001|TWO_SIDED|95.0|-4.256785|-2.343215|||t-test, 2 sided|||||-2.343215|-4.256785|<0.001
71806520|NCT04542343|143114942|OTHER||Mean Difference (Net)|-0.21818|||<|0.01|TWO_SIDED|95.0|-0.36828|-0.06809|||t-test, 2 sided|||||-0.06809|-0.36828|<0.01
71806521|NCT04542343|143114943|OTHER||Mean Difference (Net)|0.05623|STANDARD_ERROR_OF_MEAN|0.026|<|0.05|TWO_SIDED|95.0|0.00459|0.10788|||t-test, 2 sided|||||0.10788|0.00459|<0.05
71806522|NCT01816594|143114946|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||All participantss||||0.811
71806523|NCT01816594|143114947|SUPERIORITY|||||||0.83|||||||Fisher Exact|(one-sided)||wild type cohort||||0.830
71806524|NCT01816594|143114948|SUPERIORITY|||||||0.786|||||||Fisher Exact|(one-sided)||mutant cohort||||0.786
71806525|NCT01816594|143114949|SUPERIORITY|||||||0.286|||||||Fisher Exact|(one-sided)||All participants||||0.286
71806526|NCT01816594|143114950|SUPERIORITY|||||||0.177|||||||Fisher Exact|(one-sided)||wild type cohort||||0.177
71806527|NCT01816594|143114951|SUPERIORITY|||||||0.929|||||||Fisher Exact|(one-sided)||mutant cohort||||0.929
71806528|NCT01816594|143114952|SUPERIORITY|||||||0.811|||||||Fisher Exact|(one-sided)||||||0.811
71806529|NCT01816594|143114953|SUPERIORITY|||||||0.84|||||||Fisher Exact|(one-sided)||||||0.840
71806530|NCT01816594|143114954|SUPERIORITY|||||||0.724|||||||Fisher Exact|(one-sided)||||||0.724
71806531|NCT01816594|143114955|SUPERIORITY|||||||0.964|||||||Fisher Exact|(one-sided)||All participants||||0.964
71806532|NCT01816594|143114956|SUPERIORITY|||||||0.546|||||||Fisher Exact|(one-sided)||For ER+ participants - pCR||||0.546
71806533|NCT01816594|143114957|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - pCR||||0.949
71806534|NCT01816594|143114958|SUPERIORITY|||||||0.053|||||||Fisher Exact|(one-sided)||For ER+ participants - ORR||||0.053
71806535|NCT01816594|143114959|SUPERIORITY|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - ORR||||0.949
71806536|NCT01816594|143114960|SUPERIORITY|||||||0.666|||||||Fisher Exact|(one-sided)||||||0.666
71806537|NCT01816594|143114961|SUPERIORITY|||||||0.803|||||||Fisher Exact|(one-sided)||||||0.803
71842521|NCT01474122|143196754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.165|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|||||0.0|-0.3|0.165
71842522|NCT01474122|143196755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.339|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.339
71842523|NCT01474122|143196755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.312|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||||0.1|-0.2|0.312
71676017|NCT03425396|142869877|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-0.3|||||TWO_SIDED|95.0|-13.1|12.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||12.7|-13.1|
71676018|NCT03425396|142869877|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.8|||||TWO_SIDED|95.0|-20.7|7.8|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||7.8|-20.7|
71676019|NCT03425396|142869877|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-1.1|||||TWO_SIDED|95.0|-15.1|11.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||11.6|-15.1|
71676020|NCT03425396|142869877|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|8.2|||||TWO_SIDED|95.0|-35.3|20.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||20.7|-35.3|
71806538|NCT03905655|143114962|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71842524|NCT01474122|143196756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.319|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.319
71842525|NCT01474122|143196756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.221|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.221
71842526|NCT04173247|143196764|OTHER|A t-test with 180 degrees of freedom to compare the mean DLQI score over the 6 weeks in arm1 to the mean DLQI score over six weeks in arm2.||||||0.28|||||||t-test, 1 sided|||||||0.28
71842527|NCT03884101|143196774|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5550121|TWO_SIDED|95.0|0.83|1.24|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.24|0.83|0.5550121
71842528|NCT03884101|143196775|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1792058|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.10|0.77|0.1792058
71842529|NCT03884101|143196776|NON_INFERIORITY|The null hypothesis for the non-inferiority test was that the hazard ratio was equal to 1.1.|Hazard Ratio (HR)|1.02||||0.2459875|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.2459875
71676021|NCT03425396|142869878|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-6.0|||||TWO_SIDED|95.0|-27.3|13.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||13.3|-27.3|
71676022|NCT03425396|142869878|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.5|||||TWO_SIDED|95.0|-32.4|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||5.9|-32.4|
71676023|NCT03425396|142869878|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-3.0|||||TWO_SIDED|95.0|-25.7|15.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||15.6|-25.7|
71842530|NCT03884101|143196776|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5875597|TWO_SIDED|95.0|0.83|1.26|||Log Rank|One-sided p-value based on log-rank test and stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||1.26|0.83|0.5875597
71842531|NCT03884101|143196777|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21552|TWO_SIDED|95.0|0.77|1.12|||Log Rank|One-sided p-value based on log-rank test and stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Based on Cox regression model with Efron's method for tie handling with treatment as a covariate stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||1.12|0.77|0.21552
71842532|NCT03884101|143196778|OTHER||Difference in Percentage|-4.2||||0.8569|TWO_SIDED|95.0|-11.9|3.5|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by ECOG performance status and prior chemotherapy and/or chemoradiation.|||3.5|-11.9|0.8569
71676024|NCT03425396|142869878|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|10.0|||||TWO_SIDED|95.0|-40.4|28.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated|||28.9|-40.4|
71806539|NCT03905655|143114962|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71806540|NCT03905655|143114962|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71806541|NCT03905655|143114963|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71806542|NCT03905655|143114963|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71806543|NCT03905655|143114963|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71806544|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
71806545|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
71676025|NCT03425396|142869879|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-21.3|||||TWO_SIDED|95.0|-44.1|-1.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-1.0|-44.1|
71676026|NCT03425396|142869879|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.9|||||TWO_SIDED|95.0|-32.2|4.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||4.9|-32.2|
71806546|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
71806547|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
71806548|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
71806549|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
71806550|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
71806551|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 2 values||||1.000
71806552|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 4 values||||1.000
71806553|NCT03905655|143114964|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.001
71806554|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Day 3 values||||1.000
71806555|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 1 values||||1.000
71806556|NCT03905655|143114964|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Comparison of Week 2 values||||<0.001
71806557|NCT03905655|143114964|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.002
71806558|NCT03905655|143114964|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison of Week 8 values||||1.000
71676027|NCT03425396|142869879|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-19.4|||||TWO_SIDED|95.0|-43.1|1.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.1|-43.1|
71806559|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806560|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806561|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806562|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806563|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806564|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806565|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806566|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806567|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806568|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806569|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806570|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806571|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806572|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806573|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806574|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806575|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806576|NCT03905655|143114965|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806577|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806578|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806579|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806580|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806581|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806582|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806583|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806584|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806585|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806586|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806587|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806588|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806589|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806590|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806591|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806592|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806593|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806594|NCT03905655|143114966|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806595|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806596|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806597|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806598|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806599|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806600|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806601|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806602|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806603|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806604|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806605|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806606|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806607|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Day 3 values||||1.000
71806608|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 1 values||||1.000
71806609|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 2 values||||1.000
71806610|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 4 values||||1.000
71806611|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 8 values||||1.000
71806612|NCT03905655|143114967|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison of Week 12 values||||1.000
71806613|NCT03905655|143114968|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.006
71806614|NCT03905655|143114968|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.003
71806615|NCT03905655|143114968|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.004
71806616|NCT03905655|143114968|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.006
71806617|NCT03905655|143114968|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.002
71806618|NCT03905655|143114968|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.141
71806619|NCT03905655|143114968|SUPERIORITY|||||||0.081|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.081
71806620|NCT03905655|143114968|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.160
71806621|NCT03905655|143114968|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.184
71806622|NCT03905655|143114968|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.046
71806623|NCT03905655|143114968|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|||Comparison of Week 1 values||||0.379
71806624|NCT03905655|143114968|SUPERIORITY|||||||0.308|||||||t-test, 2 sided|||Comparison of Week 2 values||||0.308
71806625|NCT03905655|143114968|SUPERIORITY|||||||0.794|||||||t-test, 2 sided|||Comparison of Week 4 values||||0.794
71806626|NCT03905655|143114968|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||Comparison of Week 8 values||||0.297
71806627|NCT03905655|143114968|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Comparison of Week 12 values||||0.007
71806628|NCT03905655|143114969|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
71806629|NCT03905655|143114969|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71806630|NCT03905655|143114969|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
71806631|NCT01571362|143114979|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.246||0.0114|TWO_SIDED|95.0|-1.11|-0.14||No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (\<=) 0.05.|ANCOVA|||Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.||-0.14|-1.11|0.0114
71806632|NCT01571362|143114980|SUPERIORITY_OR_OTHER||Difference of LS Means|0.18|STANDARD_ERROR_OF_MEAN|0.565||0.7547|TWO_SIDED|95.0|-0.94|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.|ANCOVA|||||1.29|-0.94|0.7547
71806633|NCT01571362|143114981|SUPERIORITY_OR_OTHER|||||||0.1272|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)||||||0.1272
71806634|NCT01571362|143114982|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|CMH was stratified by prior pain analgesic (opioid and non-opioid).||||||0.0210
71806635|NCT01571362|143114983|SUPERIORITY_OR_OTHER|||||||0.0248|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0248
71806636|NCT01571362|143114984|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0090
71806637|NCT01571362|143114985|SUPERIORITY_OR_OTHER|||||||0.0874|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).||||||0.0874
71806638|NCT01571362|143114986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Worst Pain Score||||<0.0001
71676028|NCT03425396|142869879|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|6.7|||||TWO_SIDED|95.0|-43.8|23.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||23.2|-43.8|
71676029|NCT03425396|142869880|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-14.7|||||TWO_SIDED|95.0|-37.2|3.1|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||3.1|-37.2|
71676030|NCT03425396|142869880|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-15.9|||||TWO_SIDED|95.0|-34.3|1.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||1.2|-34.3|
71676031|NCT03425396|142869880|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-23.8|||||TWO_SIDED|95.0|-46.9|-4.3|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||-4.3|-46.9|
71676032|NCT03425396|142869880|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.4|||||TWO_SIDED|95.0|-48.5|19.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||19.7|-48.5|
71806639|NCT01571362|143114986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Least Pain Score||||<0.0001
71806640|NCT01571362|143114986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Average Pain Score||||<0.0001
71842533|NCT03884101|143196779|OTHER||Difference in Percentage|0.0||||0.4999|TWO_SIDED|95.0|-6.7|6.7|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Based on Miettinen \& Nurminen method stratified by MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|||6.7|-6.7|0.4999
71842534|NCT03884101|143196780|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-3.77||||0.0302|TWO_SIDED|95.0|-7.17|-0.36|||cLDA model|||||-0.36|-7.17|0.0302
71676033|NCT03425396|142869881|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-20.7|||||TWO_SIDED|95.0|-45.1|6.0|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||6.0|-45.1|
71676034|NCT03425396|142869881|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-17.8|||||TWO_SIDED|95.0|-40.2|5.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||5.9|-40.2|
71676035|NCT03425396|142869881|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.4|||||TWO_SIDED|95.0|-36.8|14.7|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.7|-36.8|
71676036|NCT03425396|142869881|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|3.3|||||TWO_SIDED|95.0|-47.0|33.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||33.2|-47.0|
71676037|NCT03425396|142869882|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-13.6|||||TWO_SIDED|95.0|-40.4|13.2|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||13.2|-40.4|
71806641|NCT01571362|143114986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Right Now||||<0.0001
71806642|NCT01571362|143114986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Severity Index||||<0.0001
71806643|NCT01571362|143114986|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Interference Index||||<0.0001
71806644|NCT01571362|143114987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Worst Pain Score||||<0.0001
71894483|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.07|0.63|
71676038|NCT03425396|142869882|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.6|||||TWO_SIDED|95.0|-32.7|14.6|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.6|-32.7|
71676039|NCT03425396|142869882|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-11.9|||||TWO_SIDED|95.0|-38.2|14.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||14.9|-38.2|
71676040|NCT03425396|142869882|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|1.4|||||TWO_SIDED|95.0|-50.3|30.9|||||Point estimate and exact 95% confidence intervals for difference from nitrofurantoin (omadacycline minus nitrofurantoin) in clinical success rate was estimated.|||30.9|-50.3|
71806645|NCT01571362|143114987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Least Pain Score||||<0.0001
71806646|NCT01571362|143114987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Average Pain Score||||<0.0001
71806647|NCT01571362|143114987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Right Now||||<0.0001
71806648|NCT01571362|143114987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Severity Index||||<0.0001
71806649|NCT01571362|143114987|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Interference Index||||<0.0001
71806650|NCT01571362|143114988|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.62|STANDARD_ERROR_OF_MEAN|0.222||0.0056|TWO_SIDED|95.0|-1.06|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.18|-1.06|0.0056
71806651|NCT01571362|143114988|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.243||0.009|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.16|-1.12|0.0090
71806652|NCT01571362|143114988|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.37|STANDARD_ERROR_OF_MEAN|0.271||0.1684|TWO_SIDED|95.0|-0.91|0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.16|-0.91|0.1684
71806653|NCT01571362|143114988|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.50|-1.46|<0.0001
71806654|NCT01571362|143114989|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.4|STANDARD_ERROR_OF_MEAN|0.193||0.0412|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2||-0.02|-0.78|0.0412
71806655|NCT01571362|143114989|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.87|STANDARD_ERROR_OF_MEAN|0.201|<|0.0001|TWO_SIDED|95.0|-1.27|-0.48|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4||-0.48|-1.27|<0.0001
71806656|NCT01571362|143114989|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.226||0.0055|TWO_SIDED|95.0|-1.08|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.08|0.0055
71806657|NCT01571362|143114989|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.86|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.27|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.27|<0.0001
71806658|NCT01571362|143114990|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.19||0.0007|TWO_SIDED|95.0|-1.02|-0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.27|-1.02|0.0007
71806659|NCT01571362|143114990|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.74|STANDARD_ERROR_OF_MEAN|0.213||0.0006|TWO_SIDED|95.0|-1.16|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.32|-1.16|0.0006
71806660|NCT01571362|143114990|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.18|-1.11|0.0070
71806661|NCT01571362|143114990|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.88|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-1.31|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.44|-1.31|<0.0001
71676041|NCT01314872|142869930|SUPERIORITY_OR_OTHER||Difference in least squares (LS) means|-0.46||||0.056|TWO_SIDED|95.0|-0.92|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.01|-0.92|0.056
71676042|NCT01314872|142869930|SUPERIORITY_OR_OTHER||Difference in LS means|-0.45||||0.064|TWO_SIDED|95.0|-0.93|0.03|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||0.03|-0.93|0.064
71676043|NCT01314872|142869930|SUPERIORITY_OR_OTHER||Difference in LS means|-0.64||||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.18|-1.11|0.007
71676044|NCT01314872|142869930|SUPERIORITY_OR_OTHER||Difference in LS means|-0.91|||<|0.001|TWO_SIDED|95.0|-1.37|-0.44|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.44|-1.37|< 0.001
71676045|NCT01314872|142869930|SUPERIORITY_OR_OTHER||Difference in LS means|-0.54||||0.026|TWO_SIDED|95.0|-1.02|-0.07|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.||||-0.07|-1.02|0.026
71676046|NCT01314872|142869935|SUPERIORITY_OR_OTHER||Difference in LS means|-0.28||||0.167|TWO_SIDED|95.0|-0.68|0.12|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.12|-0.68|0.167
71676047|NCT01314872|142869935|SUPERIORITY_OR_OTHER||Difference in LS means|-0.57||||0.005|TWO_SIDED|95.0|-0.97|-0.17|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.17|-0.97|0.005
71806662|NCT01571362|143114991|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.207||0.0022|TWO_SIDED|95.0|-1.05|-0.23|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.23|-1.05|0.0022
71676048|NCT01314872|142869935|SUPERIORITY_OR_OTHER||Difference in LS means|-0.72|||<|0.001|TWO_SIDED|95.0|-1.11|-0.33|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.33|-1.11|< 0.001
71676049|NCT01314872|142869935|SUPERIORITY_OR_OTHER||Difference in LS means|-0.71|||<|0.001|TWO_SIDED|95.0|-1.1|-0.32|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.32|-1.10|< 0.001
71676050|NCT01314872|142869935|SUPERIORITY_OR_OTHER||Difference in LS means|-0.46||||0.03|TWO_SIDED|95.0|-0.87|-0.04|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.04|-0.87|0.030
71676051|NCT01314872|142869936|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.18||||0.401|TWO_SIDED|95.0|-0.61|0.25|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.25|-0.61|0.401
71676052|NCT01314872|142869936|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.48||||0.029|TWO_SIDED|95.0|-0.91|-0.05|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.05|-0.91|0.029
71676053|NCT01314872|142869936|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.005|TWO_SIDED|95.0|-1.02|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.18|-1.02|0.005
71676054|NCT01314872|142869936|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.58||||0.007|TWO_SIDED|95.0|-1.01|-0.16|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.16|-1.01|0.007
71806663|NCT01571362|143114991|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.214||0.0003|TWO_SIDED|95.0|-1.21|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.21|0.0003
71806664|NCT01571362|143114991|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.264||0.0078|TWO_SIDED|95.0|-1.23|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.19|-1.23|0.0078
71806665|NCT01571362|143114991|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.07|STANDARD_ERROR_OF_MEAN|0.231|<|0.0001|TWO_SIDED|95.0|-1.52|-0.62|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.62|-1.52|<0.0001
71676055|NCT01314872|142869936|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.14|TWO_SIDED|95.0|-0.78|0.11|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.11|-0.78|0.140
71676056|NCT01314872|142869937|SUPERIORITY_OR_OTHER||Difference in LS means|-0.18||||0.598|TWO_SIDED|95.0|-0.84|0.49|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.49|-0.84|0.598
71676057|NCT01314872|142869937|SUPERIORITY_OR_OTHER||Difference in LS means|-0.67||||0.052|TWO_SIDED|95.0|-1.35|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||0.01|-1.35|0.052
71676058|NCT01314872|142869937|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76||||0.024|TWO_SIDED|95.0|-1.43|-0.1|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.10|-1.43|0.024
71676059|NCT01314872|142869937|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||<|0.001|TWO_SIDED|95.0|-1.9|-0.58|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.58|-1.90|< 0.001
71676060|NCT01314872|142869937|SUPERIORITY_OR_OTHER||Difference in LS means|-0.94||||0.007|TWO_SIDED|95.0|-1.62|-0.26|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.||||-0.26|-1.62|0.007
71676061|NCT01314872|142869938|SUPERIORITY_OR_OTHER||Difference in LS means|-0.49|||||TWO_SIDED|95.0|-1.0|0.03||||||||0.03|-1.00|
71676062|NCT01314872|142869938|SUPERIORITY_OR_OTHER||Difference in LS means|-1.1|||||TWO_SIDED|95.0|-1.62|-0.58||||||||-0.58|-1.62|
71806666|NCT01571362|143114992|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.58|STANDARD_ERROR_OF_MEAN|0.189||0.0022|TWO_SIDED|95.0|-0.95|-0.21|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.21|-0.95|0.0022
71806667|NCT01571362|143114992|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.76|STANDARD_ERROR_OF_MEAN|0.198||0.0002|TWO_SIDED|95.0|-1.15|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.37|-1.15|0.0002
71806668|NCT01571362|143114992|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.61|STANDARD_ERROR_OF_MEAN|0.228||0.0078|TWO_SIDED|95.0|-1.06|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||-0.16|-1.06|0.0078
71806669|NCT01571362|143114992|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.95|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.35|-0.54|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.54|-1.35|<0.0001
71676063|NCT01314872|142869939|SUPERIORITY_OR_OTHER||Difference in LS means|-0.29|||||TWO_SIDED|95.0|-0.71|0.13||||||||0.13|-0.71|
71676064|NCT01314872|142869939|SUPERIORITY_OR_OTHER||Difference in LS means|-0.21|||||TWO_SIDED|95.0|-0.64|0.21||||||||0.21|-0.64|
71676065|NCT01314872|142869940|SUPERIORITY_OR_OTHER||Difference in LS means|-0.07|||||TWO_SIDED|95.0|-0.56|0.43||||||||0.43|-0.56|
71676066|NCT01314872|142869940|SUPERIORITY_OR_OTHER||Difference in LS means|0.02|||||TWO_SIDED|95.0|-0.48|0.51||||||||0.51|-0.48|
71676067|NCT01314872|142869941|SUPERIORITY_OR_OTHER||Difference in LS means|-0.76|||||TWO_SIDED|95.0|-1.45|-0.08||||||||-0.08|-1.45|
71676068|NCT01314872|142869941|SUPERIORITY_OR_OTHER||Difference in LS means|-1.24|||||TWO_SIDED|95.0|-1.93|-0.56||||||||-0.56|-1.93|
71676069|NCT05088603|142869971|SUPERIORITY|||||||0.106|||||||Fisher Exact|||||||0.106
71676070|NCT05088603|142869972|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71676071|NCT05088603|142869973|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71676072|NCT05088603|142869975|SUPERIORITY|||||||0.529|||||||Fisher Exact|||||||0.529
71806670|NCT01571362|143114993|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.188||0.0285|TWO_SIDED|95.0|-0.78|-0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.||-0.04|-0.78|0.0285
71806671|NCT01571362|143114993|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.48|STANDARD_ERROR_OF_MEAN|0.188||0.0106|TWO_SIDED|95.0|-0.85|-0.11|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.||-0.11|-0.85|0.0106
71806672|NCT01571362|143114993|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.17|STANDARD_ERROR_OF_MEAN|0.222||0.4529|TWO_SIDED|95.0|-0.6|0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.||0.27|-0.60|0.4529
71806673|NCT01571362|143114993|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.65|STANDARD_ERROR_OF_MEAN|0.207||0.0018|TWO_SIDED|95.0|-1.06|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.||-0.25|-1.06|0.0018
71806674|NCT01571362|143114994|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.258||0.0061|TWO_SIDED|95.0|-1.22|-0.2|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.20|-1.22|0.0061
71676073|NCT05088603|142869976|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71676074|NCT05088603|142869977|SUPERIORITY|||||||0.502|||||||Fisher Exact|||||||0.502
71676075|NCT05088603|142869978|SUPERIORITY|||||||0.431|||||||Fisher Exact|||||||0.431
71676076|NCT05088603|142869979|SUPERIORITY|||||||0.434|||||||Fisher Exact|||||||0.434
71676077|NCT05088603|142869980|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
71676078|NCT05088603|142869981|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||0.051
71676079|NCT00594100|142869987|SUPERIORITY_OR_OTHER||Binomial Proportion|0.054|STANDARD_ERROR_OF_MEAN|0.016||0.002|TWO_SIDED|95.0|0.027|0.095|||One-Sample Binomial|Significance test was based on a one-sample binomial test|95% Confidence Interval is exact binomial using Clopper-Pearson method. Standard Error is from Normal approximation.|The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.||0.095|0.027|0.002
71806675|NCT01571362|143114994|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.277||0.0087|TWO_SIDED|95.0|-1.28|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.19|-1.28|0.0087
71806676|NCT01571362|143114994|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.56|STANDARD_ERROR_OF_MEAN|0.315||0.0769|TWO_SIDED|95.0|-1.18|0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.06|-1.18|0.0769
71806677|NCT01571362|143114994|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.1|STANDARD_ERROR_OF_MEAN|0.289||0.0002|TWO_SIDED|95.0|-1.67|-0.53|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.53|-1.67|0.0002
71806678|NCT01571362|143114995|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.51|STANDARD_ERROR_OF_MEAN|0.224||0.025|TWO_SIDED|95.0|-0.95|-0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.06|-0.95|0.0250
71806679|NCT01571362|143114995|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.89|STANDARD_ERROR_OF_MEAN|0.234||0.0002|TWO_SIDED|95.0|-1.36|-0.43|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.43|-1.36|0.0002
71806680|NCT01571362|143114995|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.263||0.0038|TWO_SIDED|95.0|-1.29|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.29|0.0038
71806681|NCT01571362|143114995|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.98|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.50|-1.46|<0.0001
71806682|NCT01571362|143114996|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.214||0.0002|TWO_SIDED|95.0|-1.22|-0.38|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.38|-1.22|0.0002
71806683|NCT01571362|143114996|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.78|STANDARD_ERROR_OF_MEAN|0.235||0.001|TWO_SIDED|95.0|-1.25|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.32|-1.25|0.0010
71842535|NCT03884101|143196781|OTHER|Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors MMR status, ECOG performance status, and prior chemotherapy and/or chemoradiation.|Difference in Least Square Means|-2.29||||0.1355|TWO_SIDED|95.0|-5.31|0.72|||cLDA model|||||0.72|-5.31|0.1355
71842536|NCT06603766|143196788|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71842537|NCT06603766|143196789|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71806684|NCT01571362|143114996|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.79|STANDARD_ERROR_OF_MEAN|0.271||0.0041|TWO_SIDED|95.0|-1.32|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.25|-1.32|0.0041
71806685|NCT01571362|143114996|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
71806686|NCT01571362|143114997|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.6|STANDARD_ERROR_OF_MEAN|0.236||0.0115|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.14|-1.06|0.0115
71806687|NCT01571362|143114997|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.256||0.0099|TWO_SIDED|95.0|-1.17|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.16|-1.17|0.0099
71806688|NCT01571362|143114997|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.71|STANDARD_ERROR_OF_MEAN|0.307||0.0222|TWO_SIDED|95.0|-1.31|-0.1|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.10|-1.31|0.0222
71842538|NCT06603766|143196790|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
71842539|NCT06603766|143196791|SUPERIORITY|||||||0.032|||||||Chi-squared|||||||0.032
71842540|NCT06603766|143196792|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71842541|NCT06603766|143196793|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71676080|NCT01270464|142869993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.0507||0.0018|TWO_SIDED|95.0|0.06|0.259||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.259|0.060|0.0018
71676081|NCT01270464|142869993|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.0508||0.0237|TWO_SIDED|95.0|0.016|0.215||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.215|0.016|0.0237
71676082|NCT01270464|142869994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.0543||0.0174|TWO_SIDED|95.0|0.023|0.237||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.237|0.023|0.0174
71676083|NCT01270464|142869994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.0543||0.3731|TWO_SIDED|95.0|-0.058|0.155||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.155|-0.058|0.3731
71806689|NCT01571362|143114997|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.264||0.0001|TWO_SIDED|95.0|-1.54|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.50|-1.54|0.0001
71806690|NCT01571362|143114998|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.66|STANDARD_ERROR_OF_MEAN|0.218||0.0025|TWO_SIDED|95.0|-1.09|-0.24|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||-0.24|-1.09|0.0025
71806691|NCT01571362|143114998|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.77|STANDARD_ERROR_OF_MEAN|0.235||0.0012|TWO_SIDED|95.0|-1.23|-0.31|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||-0.31|-1.23|0.0012
71806692|NCT01571362|143114998|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.73|STANDARD_ERROR_OF_MEAN|0.272||0.0078|TWO_SIDED|95.0|-1.27|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||-0.19|-1.27|0.0078
71806693|NCT01571362|143114998|SUPERIORITY_OR_OTHER||Difference of LS Means|-1.04|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.||-0.56|-1.52|<0.0001
71806694|NCT01571362|143114999|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.41|STANDARD_ERROR_OF_MEAN|0.228||0.0727|TWO_SIDED|95.0|-0.86|0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.||0.04|-0.86|0.0727
71806695|NCT01571362|143114999|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.47|STANDARD_ERROR_OF_MEAN|0.238||0.0501|TWO_SIDED|95.0|-0.94|0.0|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.||0.00|-0.94|0.0501
71806696|NCT01571362|143114999|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.262||0.5704|TWO_SIDED|95.0|-0.67|0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.||0.37|-0.67|0.5704
71806697|NCT01571362|143114999|SUPERIORITY_OR_OTHER||Difference of LS Means|-0.64|STANDARD_ERROR_OF_MEAN|0.245||0.0096|TWO_SIDED|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.||-0.16|-1.12|0.0096
71806698|NCT01571362|143115000|SUPERIORITY_OR_OTHER||Difference of LS Means|-27.75|STANDARD_ERROR_OF_MEAN|10.968||0.012|TWO_SIDED|95.0|-49.34|-6.16|||ANCOVA||Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|||-6.16|-49.34|0.0120
71806699|NCT01571362|143115001|SUPERIORITY_OR_OTHER||Difference of LS Means|-3.87|STANDARD_ERROR_OF_MEAN|50.5||0.939|TWO_SIDED|95.0|-103.29|95.55|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.|||95.55|-103.29|0.9390
71894484|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.39|1.11||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.11|0.39|
71894485|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.68|||||TWO_SIDED|95.0|0.5|0.92||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.50|
71676084|NCT01270464|142869995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.233|STANDARD_ERROR_OF_MEAN|0.1212||0.0552|TWO_SIDED|95.0|-0.005|0.472||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.472|-0.005|0.0552
71676085|NCT01270464|142869995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.1215||0.802|TWO_SIDED|95.0|-0.209|0.27||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.270|-0.209|0.8020
71806700|NCT01571362|143115007|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 20% loss of analgesic response||||0.0014
71806701|NCT01571362|143115007|SUPERIORITY_OR_OTHER|||||||0.0024|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 30% loss of analgesic response.||||0.0024
71806702|NCT01571362|143115007|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 40% loss of analgesic response.||||0.0006
71806703|NCT01571362|143115007|SUPERIORITY_OR_OTHER|||||||0.0021|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 50% loss of analgesic response||||0.0021
71806704|NCT01571362|143115009|SUPERIORITY_OR_OTHER|||||||0.006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors.||||||0.006
71806705|NCT01571362|143115019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to the End of Open-Label Titration Period.||||<0.0001
71894486|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.47|0.95||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.95|0.47|
71894487|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.7|1.13||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||1.13|0.70|
71806706|NCT01571362|143115020|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline.||||<0.0001
71806707|NCT01571362|143115021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.05|STANDARD_ERROR_OF_MEAN|0.584||0.0733|TWO_SIDED|95.0|-2.2|0.1||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 2.||0.10|-2.20|0.0733
71806708|NCT01571362|143115021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.642||0.2783|TWO_SIDED|95.0|-1.96|0.57||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 4.||0.57|-1.96|0.2783
71806709|NCT01571362|143115021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.684||0.3951|TWO_SIDED|95.0|-0.77|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 8.||1.93|-0.77|0.3951
71806710|NCT01571362|143115021|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.614||0.9063|TWO_SIDED|95.0|-1.14|1.28||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 12.||1.28|-1.14|0.9063
71806711|NCT01571362|143115022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|0.463||0.1139|TWO_SIDED|95.0|-1.65|0.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted change from Baseline to Week 2.||0.18|-1.65|0.1139
71806712|NCT01571362|143115022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.577||0.2264|TWO_SIDED|95.0|-1.84|0.44||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 4.||0.44|-1.84|0.2264
71806713|NCT01571362|143115022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.619||0.5074|TWO_SIDED|95.0|-0.81|1.63||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 8.||1.63|-0.81|0.5074
71806714|NCT01571362|143115023|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
71806715|NCT01571362|143115024|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Bowker's test of symmetry|||||||<0.0001
71806716|NCT01571362|143115025|SUPERIORITY_OR_OTHER|||||||0.2211|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.2211
71806717|NCT01571362|143115026|SUPERIORITY_OR_OTHER|||||||0.5767|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.5767
71806718|NCT01571362|143115029|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.||||||0.0004
71806719|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.||||<0.0001
71806720|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.||||<0.0001
71806721|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.||||<0.0001
71806722|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for General Health.||||<0.0001
71806723|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Vitality.||||<0.0001
71806724|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.||||<0.0001
71806725|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.||||<0.0001
71806726|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Health.||||<0.0001
71806727|NCT01571362|143115030|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.||||<0.0001
71806728|NCT01571362|143115030|SUPERIORITY_OR_OTHER|||||||0.0026|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.||||0.0026
71806729|NCT01571362|143115031|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score||||<0.0001
71806730|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|0.952||0.5181|TWO_SIDED|95.0|-1.26|2.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Functioning.||2.49|-1.26|0.5181
71806731|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.998||0.9733|TWO_SIDED|95.0|-2.0|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Physical.||1.93|-2.00|0.9733
71806732|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.37|STANDARD_ERROR_OF_MEAN|0.914||0.01|TWO_SIDED|95.0|0.57|4.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Bodily Pain.||4.18|0.57|0.0100
71842542|NCT05683158|143196851|OTHER||Mean Difference (Net)|1.71|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED||||||ANOVA||Mean difference between two groups of movement unit in forward direction|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
71806733|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.764||0.4712|TWO_SIDED|95.0|-2.06|0.95||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.||0.95|-2.06|0.4712
71806734|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.16|STANDARD_ERROR_OF_MEAN|1.091||0.2898|TWO_SIDED|95.0|-3.3|0.99||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Vitality.||0.99|-3.30|0.2898
71806735|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|1.044||0.1565|TWO_SIDED|95.0|-0.57|3.54||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Social Functioning.||3.54|-0.57|0.1565
71806736|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.348||0.522|TWO_SIDED|95.0|-3.52|1.79||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Emotional.||1.79|-3.52|0.5220
71806737|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.995||0.9865|TWO_SIDED|95.0|-1.94|1.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Health.||1.98|-1.94|0.9865
71806738|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.885||0.2491|TWO_SIDED|95.0|-0.72|2.77||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Component Score.||2.77|-0.72|0.2491
71806739|NCT01571362|143115032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69|STANDARD_ERROR_OF_MEAN|1.073||0.5219|TWO_SIDED|95.0|-2.8|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Component Score.||1.43|-2.80|0.5219
71806740|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.52|STANDARD_ERROR_OF_MEAN|1.111||0.1731|TWO_SIDED|95.0|-0.67|3.71||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Functioning.||3.71|-0.67|0.1731
71806741|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.127||0.329|TWO_SIDED|95.0|-1.12|3.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Physical.||3.32|-1.12|0.3290
71806742|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|1.047||0.0232|TWO_SIDED|95.0|0.33|4.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Bodily Pain.||4.45|0.33|0.0232
71806743|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.858||0.8139|TWO_SIDED|95.0|-1.89|1.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for General Health Perceptions.||1.49|-1.89|0.8139
71806744|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|1.117||0.6878|TWO_SIDED|95.0|-2.65|1.75||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Vitality.||1.75|-2.65|0.6878
71806745|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.08||0.0658|TWO_SIDED|95.0|-0.13|4.12||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Social Functioning.||4.12|-0.13|0.0658
71806746|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|1.374||0.867|TWO_SIDED|95.0|-2.48|2.94||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Emotional.||2.94|-2.48|0.8670
71806747|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|1.056||0.7259|TWO_SIDED|95.0|-1.71|2.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Health.||2.45|-1.71|0.7259
71894488|NCT01193335|143310981|SUPERIORITY_OR_OTHER||GMC Ratio|0.53|||||TWO_SIDED|95.0|0.37|0.78||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.||0.78|0.37|
71676086|NCT01270464|142869997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.359|STANDARD_ERROR_OF_MEAN|0.111||0.0014|TWO_SIDED|95.0|-0.577|-0.14||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.140|-0.577|0.0014
71676087|NCT01270464|142869997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.238|STANDARD_ERROR_OF_MEAN|0.1108||0.0329|TWO_SIDED|95.0|-0.456|-0.019||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.019|-0.456|0.0329
71676088|NCT01270464|142869998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.359|STANDARD_ERROR_OF_MEAN|0.1582||0.0241|TWO_SIDED|95.0|0.047|0.67||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.670|0.047|0.0241
71676089|NCT01270464|142869998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.1591||0.0822|TWO_SIDED|95.0|-0.036|0.591||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.591|-0.036|0.0822
71676090|NCT01270464|142869999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.0193||0.016|TWO_SIDED|95.0|0.009|0.085||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.085|0.009|0.0160
71676091|NCT01270464|142869999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.0193||0.0094|TWO_SIDED|95.0|0.012|0.089||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||0.089|0.012|0.0094
71676092|NCT01270464|142870000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|0.2551||0.0151|TWO_SIDED|95.0|-1.126|-0.121||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.121|-1.126|0.0151
71806748|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.007||0.0989|TWO_SIDED|95.0|-0.32|3.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Component Score.||3.65|-0.32|0.0989
71806749|NCT01571362|143115033|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.142||0.9969|TWO_SIDED|95.0|-2.25|2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Component Score.||2.25|-2.25|0.9969
71806750|NCT01571362|143115034|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71806751|NCT01571362|143115035|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71806752|NCT01571362|143115036|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71806753|NCT01571362|143115037|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71806754|NCT01571362|143115038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.032|STANDARD_ERROR_OF_MEAN|0.0168||0.0605|TWO_SIDED|95.0|-0.001|0.065||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||0.065|-0.001|0.0605
71806755|NCT01571362|143115039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|1.999||0.7196|TWO_SIDED|95.0|-3.22|4.66||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA|||||4.66|-3.22|0.7196
71806756|NCT01571362|143115040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.0172||0.228|TWO_SIDED|95.0|-0.013|0.055||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||0.055|-0.013|0.2280
71806757|NCT01571362|143115041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|2.048||0.2701|TWO_SIDED|95.0|-1.77|6.3||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||||6.30|-1.77|0.2701
71806758|NCT01571362|143115042|SUPERIORITY_OR_OTHER|||||||0.3822|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.||||0.3822
71894489|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.81||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.81|0.99|
71894490|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.59|2.2||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.20|0.59|
71894491|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.93||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.93|0.26|
71894492|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.98||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.98|0.80|
71676093|NCT01270464|142870000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.648|STANDARD_ERROR_OF_MEAN|0.2559||0.0119|TWO_SIDED|95.0|-1.152|-0.144||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.144|-1.152|0.0119
71806759|NCT01571362|143115042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.||||<0.0001
71806760|NCT01571362|143115042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.||||<0.0001
71894493|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.01|2.0||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.00|1.01|
71894494|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.82|1.89||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.89|0.82|
71894495|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.8|1.99||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.99|0.80|
71894496|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.56|1.15||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.56|
71894497|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.83|1.41||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.41|0.83|
71894498|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.36|0.94||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.94|0.36|
71894499|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.88|1.68||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.68|0.88|
71894500|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.78|1.39||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.39|0.78|
71894501|NCT01193335|143310987|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.89|1.51||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.51|0.89|
71806761|NCT01571362|143115042|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.||||<0.0001
71806762|NCT01571362|143115043|SUPERIORITY_OR_OTHER|||||||0.0017|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain||||0.0017
71806763|NCT01571362|143115043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain||||<0.0001
71676094|NCT01270464|142870001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.494|STANDARD_ERROR_OF_MEAN|0.0242||0|TWO_SIDED|95.0|-0.542|-0.447||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Regression, Logistic|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.447|-0.542|0.0000
71676095|NCT01270464|142870001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.323|STANDARD_ERROR_OF_MEAN|0.0243||0|TWO_SIDED|95.0|-0.37|-0.275||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.||-0.275|-0.370|0.0000
71676096|NCT02162719|142870031|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.6||||0.0372|TWO_SIDED|90.0|0.4|0.91||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||0.91|0.40|0.0372
71676097|NCT02162719|142870032|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.59||||0.1753|TWO_SIDED|90.0|0.3|1.16||Stratification variables were adjuvant/neoadjuvant treatment including treatment with or without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.16|0.30|0.1753
71676098|NCT02162719|142870033|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|0.76||||0.3636|TWO_SIDED|90.0|0.46|1.27|||Log Rank|||||1.27|0.46|0.3636
71676099|NCT02162719|142870034|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.8||||0.3607|TWO_SIDED|95.0|0.5|1.28||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.28|0.50|0.3607
71806764|NCT01571362|143115043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain||||<0.0001
71806765|NCT01571362|143115043|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain||||<0.0001
71806766|NCT01571362|143115044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.31|STANDARD_ERROR_OF_MEAN|2.883||0.1389|TWO_SIDED|95.0|-10.06|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.43|-10.06|0.1389
71894502|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.37|1.44||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.37|
71806767|NCT01571362|143115044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.88|STANDARD_ERROR_OF_MEAN|4.34||0.5094|TWO_SIDED|95.0|-11.56|5.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.80|-11.56|0.5094
71676100|NCT02162719|142870035|SUPERIORITY||Hazard Ratio (Stratified Analysis)|0.73||||0.4422|TWO_SIDED|95.0|0.32|1.65||Stratification variables were adjuvant/neoadjuvant treatment including treatment with/without radiation, disease-free interval from last dose (\<=12 vs \>12 months vs. no prior chemotherapy), PTEN status of tumor (H-score 0, vs. 1 to 150, vs. \>150).|Log Rank|||||1.65|0.32|0.4422
71676101|NCT02162719|142870036|SUPERIORITY||Hazard Ratio (Unstratified Analysis)|1.13||||0.7599|TWO_SIDED|95.0|0.52|2.47|||Log Rank|||||2.47|0.52|0.7599
71676102|NCT01369030|142870051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|STANDARD_DEVIATION|6.3||0|||||||Wilcoxon signed-rank test|||||||0.000
71676103|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.51||0.6|TWO_SIDED|95.0|-0.73|1.25||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.25|-0.73|0.60
71806768|NCT01571362|143115044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|4.043||0.4944|TWO_SIDED|95.0|-10.81|5.26||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.26|-10.81|0.4944
71806769|NCT01571362|143115045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|4.295||0.1201|TWO_SIDED|95.0|-15.33|1.81||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||1.81|-15.33|0.1201
71806770|NCT01571362|143115045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.99|STANDARD_ERROR_OF_MEAN|5.288||0.3497|TWO_SIDED|95.0|-15.6|5.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||5.62|-15.60|0.3497
71894503|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.37|1.71||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.71|0.37|
71806771|NCT01571362|143115045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.38|STANDARD_ERROR_OF_MEAN|4.532||0.6008|TWO_SIDED|95.0|-11.41|6.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||6.65|-11.41|0.6008
71806772|NCT01571362|143115046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.34|STANDARD_ERROR_OF_MEAN|4.986||0.1458|TWO_SIDED|95.0|-17.29|2.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||2.62|-17.29|0.1458
71806773|NCT01571362|143115046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.35|STANDARD_ERROR_OF_MEAN|6.496||0.1558|TWO_SIDED|95.0|-22.38|3.68||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||3.68|-22.38|0.1558
71806774|NCT01571362|143115046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.14|STANDARD_ERROR_OF_MEAN|5.582||0.3604|TWO_SIDED|95.0|-16.25|5.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||5.98|-16.25|0.3604
71842543|NCT05683158|143196851|OTHER||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED||||||ANOVA||Statistics difference among forward, ipsilateral and contralateral directions in within group|To determine the sample size, the G\*Power software was utilized, incorporating an effect size (d) of 1.9, alpha level of 0.05, and power of 0.8. A sample size of six individuals per group was considered sufficient to achieve adequate statistical power, which are α ≤ 0.05, power = 0.8, and β = 0.2.||||<.001
71842544|NCT03812614|143196865|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.07|TWO_SIDED|95.0|-0.05|1.14|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in HbA1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language.||1.14|-0.05|0.07
71842545|NCT03812614|143196866|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.67|0.64|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Linear mixed model with random intercept and slope was used to compare the change in A1c as a function of time (included using restricted cubic splines), the interaction between time and intervention arm, baseline A1c and whether PT-SP live together (stratification variables), baseline insulin use, age, vital hunger, and preferred language||0.64|-0.67|0.96
71806775|NCT01571362|143115047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.389||0.0768|TWO_SIDED|95.0|-8.95|0.46||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4||0.46|-8.95|0.0768
71842546|NCT03812614|143196867|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.55|TWO_SIDED|95.0|-6.4|3.38|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||3.38|-6.40|0.55
71806776|NCT01571362|143115047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.684||0.7109|TWO_SIDED|95.0|-4.3|6.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8||6.29|-4.30|0.7109
71806777|NCT01571362|143115047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|2.536||0.1031|TWO_SIDED|95.0|-9.14|0.85||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET||0.85|-9.14|0.1031
71842547|NCT03812614|143196868|SUPERIORITY||Mean Difference (Final Values)|5.74||||0.03|TWO_SIDED|95.0|0.57|10.91|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient SBP was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||10.91|0.57|0.03
71842548|NCT03812614|143196869|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.76|TWO_SIDED|95.0|-2.15|1.58|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.58|-2.15|0.76
71842549|NCT03812614|143196870|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.72|TWO_SIDED|95.0|-2.11|1.46|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient diabetes distress was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.46|-2.11|0.72
71842550|NCT03812614|143196871|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.38|TWO_SIDED|95.0|-0.76|0.29|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Change in patient health eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.29|-0.76|0.38
71806778|NCT01571362|143115048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.73|STANDARD_ERROR_OF_MEAN|2.776||0.0926|TWO_SIDED|95.0|-10.26|0.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||0.80|-10.26|0.0926
71806779|NCT01571362|143115048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|3.414||0.6437|TWO_SIDED|95.0|-8.42|5.24||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||5.24|-8.42|0.6437
71842551|NCT03812614|143196872|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.7|TWO_SIDED|95.0|-1.11|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient physical activity was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-1.11|0.70
71842552|NCT03812614|143196873|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.75|TWO_SIDED|95.0|-0.53|0.74|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.74|-0.53|0.75
71676104|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus their not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|0.73||0.29|TWO_SIDED|95.0|-2.22|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.66|-2.22|0.29
71676105|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.72||0.73|TWO_SIDED|95.0|-1.67|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.16|-1.67|0.73
71677325|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.742|||||TWO_SIDED|95.0|1.156|2.626||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.626|1.156|
71806780|NCT01571362|143115048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|3.391||0.748|TWO_SIDED|95.0|-7.84|5.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||5.65|-7.84|0.7480
71806781|NCT01571362|143115049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.38|STANDARD_ERROR_OF_MEAN|4.666||0.0098|TWO_SIDED|95.0|-21.68|-3.07||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-3.07|-21.68|0.0098
71806782|NCT01571362|143115049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.94|STANDARD_ERROR_OF_MEAN|5.336||0.0186|TWO_SIDED|95.0|-23.63|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.25|-23.63|0.0186
71806783|NCT01571362|143115049|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|4.785||0.0581|TWO_SIDED|95.0|-18.72|0.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.32|-18.72|0.0581
71806784|NCT01571362|143115050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.56|STANDARD_ERROR_OF_MEAN|5.168||0.0177|TWO_SIDED|95.0|-22.87|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.25|-22.87|0.0177
71806785|NCT01571362|143115050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.16|STANDARD_ERROR_OF_MEAN|5.998||0.0219|TWO_SIDED|95.0|-26.19|-2.14||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||-2.14|-26.19|0.0219
71806786|NCT01571362|143115050|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.35|STANDARD_ERROR_OF_MEAN|5.589||0.0679|TWO_SIDED|95.0|-21.47|0.78||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||0.78|-21.47|0.0679
71806787|NCT01571362|143115051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.654||0.0052|TWO_SIDED|95.0|-12.72|-2.27||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4||-2.27|-12.72|0.0052
71806788|NCT01571362|143115051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.62|STANDARD_ERROR_OF_MEAN|2.999||0.1249|TWO_SIDED|95.0|-10.54|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8||1.29|-10.54|0.1249
71806789|NCT01571362|143115051|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.19|STANDARD_ERROR_OF_MEAN|2.818||0.004|TWO_SIDED|95.0|-13.74|-2.64||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET||-2.64|-13.74|0.0040
71806790|NCT03667053|143115080|SUPERIORITY||||||<|0.001|||||||Log Rank|||The treatment group difference between dasiglucagon and placebo was evaluated inferentially using a pairwise two-sided log rank test stratified by injection site and age group.||||<0.001
71806791|NCT03667053|143115081|SUPERIORITY|||||||0.0073||||||Assessed at 30 minutes. Note that p-value was 0.0005 at 10 minutes and \<0.0001 at 15 and 20 minutes.|Cochran-Mantel-Haenszel|||The recovery rates of dasiglucagon and placebo were compared at each time point using a Cochran-Mantel-Haenszel test stratified by age group and injection site. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0073
71842553|NCT03812614|143196873|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.94|TWO_SIDED|95.0|-0.98|0.91|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.91|-0.98|0.94
71806792|NCT03667053|143115082|SUPERIORITY||||||<|0.0001||||||The p-value was \<0.0001 at all time points (10, 15, 20 and 30 minutes)|ANOVA|||Change from baseline in plasma glucose at 30, 20, 15, and 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71806793|NCT02071173|143115096|SUPERIORITY|Single group test comparison to a performance goal of 87%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.5|||||ONE_SIDED|97.5|97.0|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 87%, Ha: The Implant through 6-month lead-related complication-free rate \> 87%|||97.0|
71806794|NCT02071173|143115097|SUPERIORITY|Single group test comparison to a performance goal of 85%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|96.5|||||ONE_SIDED|95.0|93.8|||||||Ho: The Implant through 6-month lead-related complication-free rate ≤ 85%, Ha: The Implant through 6-month lead-related complication-free rate \> 85%|||93.8|
71806795|NCT02071173|143115098|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|94.0|||||ONE_SIDED|97.5|92.0|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||92.0|
71806796|NCT02071173|143115099|SUPERIORITY|Single group test comparison to a performance goal of 75%. Lower one-sided 97.5% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|91.1|||||ONE_SIDED|97.5|88.2|||||||Ho: Percentage of PCT less than or equal to 2.5V ≤ 75%, Ha: Percentage of PCT less than or equal to 2.5V \> 75%|||88.2|
71806797|NCT02071173|143115100|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|98.2|||||ONE_SIDED|95.0|97.5|||||||Ho: The Implant through 3-month lead-related complication-free rate ≤ 93%, Ha: The Implant through 3-month lead-related complication-free rate \> 93%|||97.5|
71806798|NCT02071173|143115101|SUPERIORITY|Single group test comparison to a performance goal of 94%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit exceeded performance goal, null hypothesis was rejected.|Percent|99.3|||||ONE_SIDED|95.0|98.8|||||||Ho: The 3- through 24-month lead-related complication-free rate ≤ 94%, Ha: The 3- through 24-month lead-related complication-free rate \> 94%|||98.8|
71806799|NCT02071173|143115102|SUPERIORITY|Single group test comparison to a performance goal of 1.5 Volts. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|0.56|||||ONE_SIDED|95.0||0.58||||||Ho: The 3-month mean PCT ≥ 1.5 Volts, Ha: The 3-month mean PCT \< 1.5 Volts||0.58||
71806800|NCT02071173|143115103|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|17.4|||||ONE_SIDED|95.0|16.7|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||16.7|
71806801|NCT02071173|143115104|SUPERIORITY|Single group test comparison to a performance goal of 3 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|16.1|||||ONE_SIDED|97.5|15.1|||||||Ho: The 3-month mean sensed amplitude ≤ 3 mV, Ha: The 3-month mean sensed amplitude \> 3 mV|||15.1|
71842554|NCT03812614|143196873|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.42|TWO_SIDED|95.0|-1.46|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.46|0.42
71806802|NCT02071173|143115105|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|776.0|||||ONE_SIDED|97.5|753.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||753|
71806803|NCT02071173|143115106|SUPERIORITY|Single group test comparison to a performance goal of 300 ohms. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|805.0|||||ONE_SIDED|97.5|763.0|||||||Ho: The 3-month mean pacing impedance ≤ 300 ohms, Ha: The 3-month mean pacing impedance \> 300 ohms|||763|
71806804|NCT02071173|143115107|SUPERIORITY|Single group test comparison to a performance goal of 4.5 seconds. Upper one-sided 95% confidence limit was compared to the performance goal. If upper confidence limit was lower than the performance goal, null hypothesis was rejected.|Mean|3.14|||||ONE_SIDED|95.0||3.2||||||Ho: The mean detection time ≥ 4.5 seconds, Ha: The mean detection time \< 4.5 seconds||3.20||
71806805|NCT02071173|143115108|SUPERIORITY|Single group test comparison to a performance goal of 5 mV. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Mean|18.3|||||ONE_SIDED|95.0|6.2|||||||Ho: The 3-month mean sensed amplitude ≤ 5 mV, Ha: The 3-month mean sensed amplitude \> 5 mV|||6.2|
71806806|NCT02071173|143115109|OTHER|Two one-sided tests (TOST) were performed.|Mean|468.0|||||TWO_SIDED|90.0|463.0|472.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||472|463|
71806807|NCT02071173|143115110|OTHER|Two one-sided tests (TOST) were performed.|Mean|702.0|||||TWO_SIDED|90.0|659.0|744.0||||||Ho: Pacing impedance ≤ 300 Ω or pacing impedance ≥ 1200 Ω, Ha: 300 Ω \< Pacing impedance \< 1200 Ω||744|659|
71806808|NCT02071173|143115111|SUPERIORITY|Single group test comparison to a performance goal of 93%. Lower one-sided 95% confidence limit was compared to the performance goal. If lower confidence limit was greater than the performance goal, null hypothesis was rejected.|Percent|99.5|||||ONE_SIDED|95.0|98.4|||||||Ho: Percent of successful conversion ≤ 93%, Ha: Percent of successful conversion \> 93%|||98.4|
71806809|NCT04118348|143115112|SUPERIORITY||Odds Ratio (OR)|5.73|||<|0.001|TWO_SIDED|95.0|4.46|7.36|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||7.36|4.46|<.001
71806810|NCT04118348|143115112|SUPERIORITY||Odds Ratio (OR)|4.87|||<|0.001|TWO_SIDED|95.0|3.79|6.27|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||6.27|3.79|<.001
71806811|NCT04118348|143115112|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.19|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.19|1.28|<.001
71806812|NCT04118348|143115112|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|2.73|4.29|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||4.29|2.73|<.001
71806813|NCT04118348|143115112|SUPERIORITY||Odds Ratio (OR)|2.92|||<|0.001|TWO_SIDED|95.0|2.32|3.66|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||3.66|2.32|<.001
71806814|NCT04118348|143115112|SUPERIORITY||Odds Ratio (OR)|1.17||||0.114|TWO_SIDED|95.0|0.96|1.43|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.43|0.96|.114
71806815|NCT04118348|143115113|SUPERIORITY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|2.02|4.15|||Regression, Logistic||BPA+HMT is the numerator|Passive control was set as the reference group.||4.15|2.02|<.001
71806816|NCT04118348|143115113|SUPERIORITY||Odds Ratio (OR)|2.28|||<|0.001|TWO_SIDED|95.0|1.57|3.3|||Regression, Logistic||BPA-only is the numerator|Passive control was set as the reference group.||3.30|1.57|<.001
71806817|NCT04118348|143115113|SUPERIORITY||Odds Ratio (OR)|1.54||||0.03|TWO_SIDED|95.0|1.04|2.27|||Regression, Logistic||HMT-only is the numerator|Passive control was set as the reference group.||2.27|1.04|.030
71842555|NCT03812614|143196874|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.96|TWO_SIDED|95.0|-0.54|0.52|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient self-efficacy was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.52|-0.54|0.96
71842556|NCT03812614|143196875|SUPERIORITY||Mean Difference (Final Values)|2.93||||0.4|TWO_SIDED|95.0|-3.92|9.78|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||9.78|-3.92|0.40
71842557|NCT03812614|143196876|SUPERIORITY||Mean Difference (Final Values)|0.75||||0.11|TWO_SIDED|95.0|-0.18|1.68|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.68|-0.18|0.11
71842558|NCT03812614|143196877|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.34|TWO_SIDED|95.0|-0.19|0.55|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.55|-0.19|0.34
71894504|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|0.76|3.12||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.12|0.76|
71677326|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.306|||||TWO_SIDED|95.0|0.204|0.458||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.458|0.204|
71806818|NCT04118348|143115113|SUPERIORITY||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.37|2.59|||Regression, Logistic||BPA+HMT is the numerator|HMT was set as the reference group.||2.59|1.37|<.001
71806819|NCT04118348|143115113|SUPERIORITY||Odds Ratio (OR)|1.48||||0.021|TWO_SIDED|95.0|1.06|2.06|||Regression, Logistic||BPA-only is the numerator|HMT was set as the reference group.||2.06|1.06|.021
71806820|NCT04118348|143115113|SUPERIORITY||Odds Ratio (OR)|1.27||||0.107|TWO_SIDED|95.0|0.95|1.71|||Regression, Logistic||BPA+HMT is the numerator|BPA was set as the reference group.||1.71|0.95|.107
71806821|NCT00121238|143115115|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
71806822|NCT04642638|143115166|OTHER||Difference in median|6.7|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|0.0|6.7|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% confidence interval (CI).|||6.70|0.00|
71806823|NCT04642638|143115166|OTHER||Difference in median|13.3|STANDARD_ERROR_OF_MEAN|10.55|||TWO_SIDED|95.0|3.3|17.8|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||17.80|3.30|
71806824|NCT04642638|143115166|OTHER||Difference in median|-6.6|STANDARD_ERROR_OF_MEAN|-5.0|||TWO_SIDED|95.0|-10.0|0.0|||||Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI.|||0.00|-10.00|
71806825|NCT04642638|143115167|OTHER||Geometric Mean Fold Rise (GMFR) Ratio|2.5|||||TWO_SIDED|95.0|1.72|3.632|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||3.632|1.720|
71806826|NCT04642638|143115167|OTHER||GMFR Ratio|3.88|||||TWO_SIDED|95.0|2.638|5.7|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons.|||5.700|2.638|
71806827|NCT04642638|143115167|OTHER||GMFR Ratio|0.68|||||TWO_SIDED|95.0|0.512|0.893|||||95% CI of GMFR ratio is based on t-distribution, where GMFR ratio is based on the between-treatment-group comparisons|||0.893|0.512|
71806828|NCT02085408|143115190|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.94|1.3|||Regression, Cox||Hazard ratio : clofarabine/(daunorubicin \& cytarabine)|||1.30|0.94|
71806829|NCT02085408|143115191|SUPERIORITY|||||||0.94|||||||Fisher Exact|||||||0.94
71676106|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.04||0.77|TWO_SIDED|95.0|-2.34|1.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.74|-2.34|0.77
71676107|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|1.1||0.51|TWO_SIDED|95.0|-1.43|2.88||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.88|-1.43|0.51
71806830|NCT02273141|143115206|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|8.22||||0.038|ONE_SIDED|97.5|-0.5|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate non-inferiority (NI) of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-0.50|0.038
71806831|NCT02273141|143115207|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|3.2||||0.027|ONE_SIDED|97.5|-5.56|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 success rate - SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-5.56|0.027
71806832|NCT02273141|143115208|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|2.42||||0.154|TWO_SIDED|95.0|-6.35|11.12||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.12|-6.35|0.154
71806833|NCT02273141|143115209|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.27||||0.212|TWO_SIDED|95.0|-5.56|11.91||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.91|-5.56|0.212
71894505|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.33|1.17||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.33|
71894506|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.24|1.55||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.55|0.24|
71806834|NCT02273141|143115210|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|4.43||||0.064|TWO_SIDED|95.0|-4.36|13.1||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||13.10|-4.36|0.064
71806835|NCT02273141|143115211|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|2.95||||0.278|TWO_SIDED|95.0|-5.96|11.51||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate - SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||11.51|-5.96|0.278
71806836|NCT00529399|143115221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.98
71806837|NCT00529399|143115221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|||||||ANCOVA|||"The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis."||||0.51
71806838|NCT02486328|143115239|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71806839|NCT02486328|143115240|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71806840|NCT02486328|143115241|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71806841|NCT02486328|143115242|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71806842|NCT02486328|143115243|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71894507|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.97|1.77||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.77|0.97|
71677327|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.165|||||TWO_SIDED|95.0|0.11|0.248||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.248|0.110|
71806843|NCT02486328|143115244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71806844|NCT04313881|143115252|SUPERIORITY||Odds Ratio (OR)|0.876||||0.5218|TWO_SIDED|95.0|0.585|1.312||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.312|0.585|0.5218
71806845|NCT04313881|143115253|SUPERIORITY||Hazard Ratio (HR)|1.203||||0.1299|TWO_SIDED|95.0|0.947|1.528||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% confidence interval (CI) were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.528|0.947|0.1299
71806846|NCT04313881|143115255|SUPERIORITY||Odds Ratio (OR)|0.821||||0.2563|TWO_SIDED|95.0|0.584|1.155||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel|||||1.155|0.584|0.2563
71806847|NCT04313881|143115257|SUPERIORITY||Odds Ratio (OR)|0.72||||0.2191|TWO_SIDED|95.0|0.427|1.212||95% CI for transfusion independence rate was based on Clopper-Pearson exact method. 2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors.|Cochran-Mantel-Haenszel|||||1.212|0.427|0.2191
71806848|NCT04313881|143115258|SUPERIORITY||Hazard Ratio (HR)|0.979||||0.8788|TWO_SIDED|95.0|0.746|1.285||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.285|0.746|0.8788
71806849|NCT04313881|143115259|SUPERIORITY||Odds Ratio (OR)|0.441||||0.0375|TWO_SIDED|95.0|0.203|0.96||2-sided P-value, odds ratio and its 95% CI were based on unstratified Cochran-Mantel-Haenszel (CMH) method.|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.960|0.203|0.0375
71806850|NCT04313881|143115260|SUPERIORITY||Odds Ratio (OR)|0.947||||0.795|TWO_SIDED|95.0|0.629|1.426||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||1.426|0.629|0.7950
71806851|NCT04313881|143115261|SUPERIORITY||Hazard Ratio (HR)|0.837||||0.461|TWO_SIDED|95.0|0.522|1.343||2-sided P-value was based on stratified log-rank test, stratified by stratification factors.|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.343|0.522|0.4610
71806852|NCT04313881|143115262|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.872|TWO_SIDED|95.0|0.802|1.297||2-sided P-value was based on stratified log-rank test, stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Log Rank||Hazard ratio and its 95% CI were calculated using the Cox proportional hazards regression model, stratified by stratification factors.|||1.297|0.802|0.8720
71806853|NCT04313881|143115263|SUPERIORITY|2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors|Odds Ratio (OR)|0.605||||0.0048|TWO_SIDED|95.0|0.428|0.857||2-sided P-value, odds ratio and its 95% CI were based on Cochran-Mantel-Haenszel (CMH) method stratified by stratification factors (geographic region, cytogenetic risk status, and bone marrow blast percentage).|Cochran-Mantel-Haenszel||95% CI for response rate was based on Clopper-Pearson exact method.|||0.857|0.428|0.0048
71806854|NCT00688636|143115270|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Fisher Exact|||||||.0005
71806855|NCT01572727|143115275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.82|1.68||||||||1.68|0.82|
71806856|NCT04053764|143115283|SUPERIORITY||Odds Ratio (OR)|1.94|||||TWO_SIDED|95.0|0.53|7.14||||||||7.14|0.53|
71806857|NCT04053764|143115285|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.23|2.31||||||||2.31|0.23|
71806858|NCT04053764|143115286|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.29|3.02||||||PCR Improvement||3.02|0.29|
71806859|NCT04053764|143115286|SUPERIORITY||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.18|3.2||||||Stable PCR||3.20|0.18|
71806860|NCT04053764|143115287|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-5.53|4.65||||||From baseline to 3 months||4.65|-5.53|
71806861|NCT04053764|143115287|SUPERIORITY||Mean Difference (Final Values)|4.69|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-2.02|11.4||||||From baseline to 6 months||11.40|-2.02|
71842559|NCT03812614|143196879|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.47|TWO_SIDED|95.0|-2.67|1.23|||Mixed Models Analysis||Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.23|-2.67|0.47
71806862|NCT04053764|143115287|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-3.58|11.68||||||From baseline to 9 months||11.68|-3.58|
71806863|NCT04053764|143115287|SUPERIORITY||Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|4.17|||TWO_SIDED|95.0|-3.28|13.67||||||From baseline to 12 months||13.67|-3.28|
71806864|NCT04053764|143115290|SUPERIORITY||Odds Ratio (OR)|0.32|||||TWO_SIDED|95.0|0.09|1.21||||||||1.21|0.09|
71806865|NCT02935062|143115295|SUPERIORITY|||||||0.001|||||||t-test, 1 sided|||||||0.001
71806866|NCT02935062|143115296|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|||||||0.011
71806867|NCT01968213|143115345|SUPERIORITY||Cox Proportional Hazard|0.365|||<|0.0001|TWO_SIDED|95.0|0.295|0.451|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.451|0.295|<0.0001
71806868|NCT01968213|143115346|SUPERIORITY||Cox Proportional Hazard|0.354|||<|0.0001|TWO_SIDED|95.0|0.278|0.45|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.|0.450|0.278|<0.0001
71806869|NCT01392560|143115356|SUPERIORITY_OR_OTHER||Mean change from baseline|-19.6|STANDARD_ERROR_OF_MEAN|5.6||0.0011|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for all patients||||0.0011
71806870|NCT01392560|143115356|SUPERIORITY_OR_OTHER||Mean change from baseline|-30.8|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients||||<0.0001
71806871|NCT01392560|143115356|SUPERIORITY_OR_OTHER||Change from baseline|-33.4|STANDARD_ERROR_OF_MEAN|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers||||<0.0001
71806872|NCT01392560|143115356|SUPERIORITY_OR_OTHER||Mean change from baseline|-44.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers||||<0.0001
71806873|NCT01392560|143115356|SUPERIORITY_OR_OTHER||Mean change from baseline|9.0|STANDARD_ERROR_OF_MEAN|5.9||0.1524|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers||||0.1524
71806874|NCT01392560|143115356|SUPERIORITY_OR_OTHER||Mean change from baseline|-2.4|STANDARD_ERROR_OF_MEAN|7.7||0.7585|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers||||0.7585
71806875|NCT02558010|143115357|SUPERIORITY||||||<|0.05||||||The p-value was calculated, and does not indicate the threshold for statistical significance.|Mixed Models Analysis|||||||<0.05
71806876|NCT03301051|143115437|OTHER|Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants \[ARV\]/attack rate in unvaccinated participants \[ARU\]) x 100%.|Vaccine Efficacy|34.9|||||TWO_SIDED|95.0|17.6|48.6|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% confidence interval (CI).|||48.6|17.6|
71806877|NCT03301051|143115438|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|38.6|||||TWO_SIDED|95.0|27.6|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|27.6|
71676108|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.02||0.05|TWO_SIDED|95.0|0.02|4.01||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||4.01|0.02|0.05
71842560|NCT03812614|143196880|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.35|TWO_SIDED|95.0|-0.78|0.27|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||0.27|-0.78|0.35
71676109|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.91|STANDARD_ERROR_OF_MEAN|1.49||0.54|TWO_SIDED|95.0|-3.84|2.02||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.02|-3.84|0.54
71676110|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.02|STANDARD_ERROR_OF_MEAN|1.61||0.21|TWO_SIDED|95.0|-1.13|5.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||5.17|-1.13|0.21
71676111|NCT04075682|142870112|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|1.48||0.47|TWO_SIDED|95.0|-3.97|1.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.83|-3.97|0.47
71806878|NCT03301051|143115439|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|33.8|||||TWO_SIDED|95.0|14.9|48.5|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.5|14.9|
71806879|NCT03301051|143115440|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|37.6|||||TWO_SIDED|95.0|25.1|48.0|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||48.0|25.1|
71806880|NCT03301051|143115441|OTHER|VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.|Vaccine Efficacy|6.2|||||TWO_SIDED|95.0|0.8|11.3|||||The VE success criterion is defined as a \>40% lower limit of the two-sided 95% CI.|||11.3|0.8|
71806881|NCT01962493|143115571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.155||0.1313|TWO_SIDED|95.0|-0.51|0.1||Analysis based on square root transformation. Results back transformed for interpretation.|ANCOVA|Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.|Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment|Null hypothesis stated that there was no difference between treatment groups||0.10|-0.51|0.1313
71806882|NCT04414696|143115591|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.3|1.5|||||Multivariable linear regression|||1.5|-3.3|
71842561|NCT03812614|143196881|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient healthy eating was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.01|-1.00|0.06
71806883|NCT04414696|143115592|SUPERIORITY||Mean Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-23.5|14.5|||||Multivariable linear regression|||14.5|-23.5|
71806884|NCT04414696|143115593|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-1.9|9.5||||||||9.5|-1.9|
71806885|NCT04414696|143115594|SUPERIORITY||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-18.9|21.5|||||Multivariable linear regression|||21.5|-18.9|
71806886|NCT04414696|143115595|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||Multivariable linear regression|||1.1|-3.7|
71806887|NCT04414696|143115596|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-7.7|4.2|||||Multivariable linear regression|||4.2|-7.7|
71806888|NCT04414696|143115597|SUPERIORITY||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.2|2.1|||||Multivariable linear regression|||2.1|-1.2|
71676112|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.49||0.57|TWO_SIDED|95.0|-0.68|1.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.24|-0.68|0.57
71676113|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.25|STANDARD_ERROR_OF_MEAN|0.71||0.08|TWO_SIDED|95.0|-2.63|0.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.14|-2.63|0.08
71676114|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.39|TWO_SIDED|95.0|-1.97|0.77||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment, comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.77|-1.97|0.39
71676115|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|1.0||0.61|TWO_SIDED|95.0|-1.45|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.47|-1.45|0.61
71676116|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.07||0.9|TWO_SIDED|95.0|-2.23|1.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.97|-2.23|0.90
71677328|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.545|||||TWO_SIDED|95.0|0.363|0.818||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.818|0.363|
71806889|NCT04414696|143115598|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.1|||||Multivariable linear regression|||1.1|-1|
71806890|NCT04414696|143115599|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.4|1.2|||||Multivariable linear regression|||1.2|-3.4|
71806891|NCT04414696|143115600|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-4.9|1.3|||||Multivariable linear regression|||1.3|-4.9|
71806892|NCT02621931|143115621|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.46|-1.15||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the statistical analysis plan (SAP).||-1.15|-2.46|<0.0001
71842562|NCT03812614|143196882|SUPERIORITY||Median Difference (Final Values)|-0.34||||0.45|TWO_SIDED|95.0|-1.22|0.54|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.54|-1.22|0.45
71676117|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|2.05|STANDARD_ERROR_OF_MEAN|0.98||0.04|TWO_SIDED|95.0|0.13|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.97|0.13|0.04
71676118|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|1.43||0.64|TWO_SIDED|95.0|-2.14|3.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.48|-2.14|0.64
71806893|NCT02621931|143115621|SUPERIORITY||LSM difference from placebo|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.76|-1.45||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||-1.45|-2.76|<0.0001
71806894|NCT02621931|143115623|SUPERIORITY||LSM difference from placebo|-1.7|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.48|-0.97||0.05 level of significance|ANCOVA|||||-0.97|-2.48|<0.0001
71806895|NCT02621931|143115623|SUPERIORITY||LSM difference from placebo|-1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001|TWO_SIDED|95.0|-2.61|-1.09||0.05 level of significance|ANCOVA|||||-1.09|-2.61|<0.0001
71806896|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/placebo/placebo to Placebo||||<0.0001
71806897|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/225/225 to Placebo||||<0.0001
71806898|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
71806899|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2||||<0.0001
71842563|NCT03812614|143196883|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.4|TWO_SIDED|95.0|-0.86|0.35|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient diabetes medication adherence was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.35|-0.86|0.40
71842564|NCT03812614|143196883|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.98|TWO_SIDED|95.0|-0.9|0.88|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient blood pressure medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.88|-0.90|0.98
71806900|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
71806901|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3||||<0.0001
71806902|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
71842565|NCT03812614|143196883|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.43|TWO_SIDED|95.0|-1.42|0.61|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient cholesterol medication adherence (days/week meds were taken) was analyzed in a manner similar to that described for the primary outcome (6month change in patient A1c). Analyses were ITT and thus based on data from all enrolled patients.||0.61|-1.42|0.43
71842566|NCT03812614|143196884|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.06|TWO_SIDED|95.0|-1.0|0.01|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|||0.01|-1.00|0.06
71806903|NCT02621931|143115624|SUPERIORITY||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall||||<0.0001
71842567|NCT03812614|143196885|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.92|TWO_SIDED|95.0|-7.22|6.49|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient activation was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||6.49|-7.22|0.92
71842568|NCT03812614|143196886|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.02|TWO_SIDED|95.0|0.21|1.99|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient satisfaction with SP support was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||1.99|0.21|0.02
71676119|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|1.56||0.92|TWO_SIDED|95.0|-2.91|3.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.20|-2.91|0.92
71806904|NCT02621931|143115625|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71806905|NCT02621931|143115625|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71806906|NCT02621931|143115626|SUPERIORITY||LSM difference from placebo|-2.3|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.95|-1.73||0.05 level of significance|ANCOVA|||||-1.73|-2.95|<0.0001
71806907|NCT02621931|143115627|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71806908|NCT02621931|143115627|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71806909|NCT02621931|143115628|SUPERIORITY|||||||0.0004||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||0.0004
71806910|NCT02621931|143115628|SUPERIORITY||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.||||<0.0001
71806911|NCT02008890|143115656|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5722|TWO_SIDED|95.0|0.5|3.53|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.53|0.50|0.5722
71806912|NCT02008890|143115656|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0411|TWO_SIDED|95.0|1.04|6.6|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||6.60|1.04|0.0411
71806913|NCT02008890|143115657|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.9431|TWO_SIDED|95.0|-4.59|3.47|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||3.47|-4.59|0.9431
71806914|NCT02008890|143115657|SUPERIORITY||Mean Difference (Final Values)|-3.13||||0.1576|TWO_SIDED|95.0|-7.14|0.88|||Regression, Linear|with factors treatment, country, body weight at baseline visit (\> 90 kg or \>= 90kg) and presence of plaque-type psoriasis||||0.88|-7.14|0.1576
71842569|NCT03812614|143196887|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.06|TWO_SIDED|95.0|-0.01|0.7|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Change in patient perception of supportive and non-supportive behaviors was analyzed in a manner similar to that described for the primary outcome (6-month change in patient A1c).||0.70|-0.01|0.06
71806915|NCT02207816|143115664|SUPERIORITY||Vaccine efficacy|74.38||||0.2235|TWO_SIDED|95.0|-130.0|97.14|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||97.14|-130|0.2235
71806916|NCT02207816|143115664|SUPERIORITY||Vaccine efficacy|-9.57||||0.8972|TWO_SIDED|95.0|-339.0|72.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||72.64|-339|0.8972
71842570|NCT03812614|143196888|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.49|TWO_SIDED|95.0|-2.19|4.57|||Mixed Models Analysis|||Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.|Positive coefficient favors I-DSMES; negative coefficient favors FAM-ACT|4.57|-2.19|0.49
71842571|NCT03812614|143196889|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.08|TWO_SIDED|95.0|-0.09|1.66|||Mixed Models Analysis||Positive coefficient favors FAM-ACT; negative coefficient favors I-DSMES|Support Persons (SPs) were surveyed twice, once at baseline and again at the end of their participation in the study. For SPs enrolled before the start of the COVID-19 pandemic (n=77), the follow-up survey was conducted at 12 months. Due to factors related to the pandemic, the length of the protocol was reduced from 12 to 6 months. Thus, SPs enrolled after the pandemic started (n=145) received their follow-up survey at 6 months, and 6-month change was used for predetermined SP outcomes.||1.66|-0.09|0.08
71842572|NCT04763772|143196912|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.2|TWO_SIDED|95.0|-14.0|4.8|||Regression, Linear|||||4.8|-14|0.2
71806917|NCT02207816|143115664|SUPERIORITY||Vaccine efficacy|30.58||||0.5333|TWO_SIDED|95.0|-119.0|78.0|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||78.00|-119|0.5333
71806918|NCT02207816|143115664|SUPERIORITY||Vaccine efficacy|44.2||||0.3523|TWO_SIDED|95.0|-90.9|83.69|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||83.69|-90.9|0.3523
71806919|NCT02207816|143115665|SUPERIORITY||Vaccine efficacy|53.68||||0.093|TWO_SIDED|95.0|-13.7|81.13|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||81.13|-13.7|0.0930
71806920|NCT02207816|143115665|SUPERIORITY||Vaccine efficacy|23.33||||0.5035|TWO_SIDED|95.0|-67.1|64.82|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||64.82|-67.1|0.5035
71806921|NCT02207816|143115665|SUPERIORITY||Vaccine efficacy|32.08||||0.3504|TWO_SIDED|95.0|-53.1|69.87|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||69.87|-53.1|0.3504
71806922|NCT02207816|143115665|SUPERIORITY||Vaccine efficacy|37.57||||0.2704|TWO_SIDED|95.0|-44.4|73.01|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||73.01|-44.4|0.2704
71806923|NCT02207816|143115666|SUPERIORITY||Vaccine efficacy|-5.26||||0.4434|TWO_SIDED|95.0|-20.0|7.69|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||7.69|-20.0|0.4434
71806924|NCT02207816|143115666|SUPERIORITY||Vaccine efficacy|-8.1||||0.2634|TWO_SIDED|95.0|-23.9|5.7|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||5.70|-23.9|0.2634
71806925|NCT02207816|143115666|SUPERIORITY||Vaccine efficacy|0.62||||0.9278|TWO_SIDED|95.0|-13.7|13.13|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||13.13|-13.7|0.9278
71806926|NCT02207816|143115666|SUPERIORITY||Vaccine efficacy|5.32||||0.4189|TWO_SIDED|95.0|-8.12|17.09|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||17.09|-8.12|0.4189
71806927|NCT02207816|143115667|SUPERIORITY||Vaccine efficacy|50.1||||0.1302|TWO_SIDED|95.0|-32.2|82.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||82.90|-32.2|0.1302
71806928|NCT02207816|143115667|SUPERIORITY||Vaccine efficacy|16.9||||0.6897|TWO_SIDED|95.0|-96.9|65.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||65.90|-96.9|0.6897
71806929|NCT02207816|143115667|SUPERIORITY||Vaccine efficacy|25.9||||0.5299|TWO_SIDED|95.0|-82.9|70.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.90|-82.9|0.5299
71806930|NCT02207816|143115667|SUPERIORITY||Vaccine efficacy|25.4||||0.5307|TWO_SIDED|95.0|-84.1|70.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||70.70|-84.1|0.5307
71806931|NCT02207816|143115668|SUPERIORITY||Vaccine efficacy|46.2||||0.1853|TWO_SIDED|95.0|-45.0|81.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||81.80|-45.0|0.1853
71842573|NCT04675034|143196913|SUPERIORITY||Combined estimate for LS mean|-0.15|STANDARD_ERROR_OF_MEAN|0.416||0.36|TWO_SIDED|95.0|-0.968|0.67|||ANCOVA|Least Square (LS) mean and treatment group difference with associated 95% confidence intervals (CIs) are modelled using ANCOVA on imputed data.||||0.670|-0.968|0.360
71806932|NCT02207816|143115668|SUPERIORITY||Vaccine efficacy|35.0||||0.3828|TWO_SIDED|95.0|-69.3|76.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.60|-69.3|0.3828
71842574|NCT04675034|143196913|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.418||0.029|TWO_SIDED|95.0|-1.619|0.027|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.027|-1.619|0.029
71842575|NCT04675034|143196913|SUPERIORITY||Combined estimate for LS mean|-0.8|STANDARD_ERROR_OF_MEAN|0.413||0.026|TWO_SIDED|95.0|-1.618|0.009|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.009|-1.618|0.026
71842576|NCT04675034|143196913|SUPERIORITY||Combined estimate for LS mean|-0.59|STANDARD_ERROR_OF_MEAN|0.424||0.083|TWO_SIDED|95.0|-1.423|0.245|||ANCOVA|Least Square mean and treatment group difference with associated 95% CIs are modelled using ANCOVA on imputed data.||||0.245|-1.423|0.083
71806933|NCT02207816|143115668|SUPERIORITY||Vaccine efficacy|31.2||||0.4112|TWO_SIDED|95.0|-66.5|72.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.70|-66.5|0.4112
71806934|NCT02207816|143115668|SUPERIORITY||Vaccine efficacy|30.8||||0.4121|TWO_SIDED|95.0|-67.6|72.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||72.50|-67.6|0.4121
71806935|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|40.8|||<|0.0001|TWO_SIDED|95.0|15.7|58.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||58.80|15.70|<0.0001
71806936|NCT02207816|143115669|SUPERIORITY||Vaccine effiicacy|42.7|||<|0.0001|TWO_SIDED|95.0|17.4|60.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||60.80|17.40|<0.0001
71806937|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|16.0||||0.0883|TWO_SIDED|95.0|-6.6|33.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||33.90|-6.60|0.0883
71806938|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|13.0||||0.1889|TWO_SIDED|95.0|-10.7|31.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||31.70|-10.7|0.1889
71842577|NCT04163991|143196943|SUPERIORITY||Least Squares (LS) Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.38||0.0296|TWO_SIDED|90.0|-1.47|-0.21||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.21|-1.47|0.0296
71842578|NCT04163991|143196943|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0355|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0355
71842579|NCT04163991|143196943|SUPERIORITY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.38||0.0364|TWO_SIDED|90.0|-1.44|-0.18||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.18|-1.44|0.0364
71842580|NCT04163991|143196943|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.38||0.0478|TWO_SIDED|90.0|-1.41|-0.13||Results are from MMRM analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.|MMRM||LS Mean difference is VIB4920 minus placebo. Differences less than 0 favor VIB4920.|||-0.13|-1.41|0.0478
71842581|NCT04163991|143196954|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0584|TWO_SIDED|90.0|0.43|0.94||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.94|0.43|0.0584
71842582|NCT04163991|143196954|OTHER||Ratio of geometric mean versus placebo|0.76||||0.2274|TWO_SIDED|90.0|0.51|1.11||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.11|0.51|0.2274
71676120|NCT04075682|142870113|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.25|STANDARD_ERROR_OF_MEAN|1.41||0.11|TWO_SIDED|95.0|-5.02|0.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||0.52|-5.02|0.11
71676121|NCT04075682|142870114|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.59||0.57|TWO_SIDED|95.0|-1.48|0.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.82|-1.48|0.57
71676122|NCT04075682|142870114|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|1.14||0.39|TWO_SIDED|95.0|-3.22|1.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial warnings (averaged over insert) vs no pictorial warnings (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.27|-3.22|0.39
71676123|NCT04075682|142870114|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|1.63||0.92|TWO_SIDED|95.0|-3.35|3.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.04|-3.35|0.92
71676124|NCT04075682|142870115|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.48||0.4|TWO_SIDED|95.0|-1.33|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.53|-1.33|0.40
71806939|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|16.4||||0.077|TWO_SIDED|95.0|-5.9|34.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||34.00|-5.90|0.0770
71806940|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|0.1||||1|TWO_SIDED|95.0|-25.8|20.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||20.70|-25.8|1.0000
71806941|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|20.8||||0.1624|TWO_SIDED|95.0|-17.5|46.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||46.90|-17.5|0.1624
71806942|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|-2.3||||0.9112|TWO_SIDED|95.0|-47.6|29.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||29.00|-47.6|0.9112
71806943|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|9.2||||0.4023|TWO_SIDED|95.0|-18.0|30.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||30.10|-18.0|0.4023
71806944|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|-4.4||||0.7091|TWO_SIDED|95.0|-34.5|18.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||18.90|-34.5|0.7091
71676125|NCT04075682|142870115|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.94||0.99|TWO_SIDED|95.0|-1.83|1.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial health warning labels (HWLs) (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.86|-1.83|0.99
71806945|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|-1.4||||0.9361|TWO_SIDED|95.0|-34.7|23.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||23.60|-34.7|0.9361
71806946|NCT02207816|143115669|SUPERIORITY||Vaccine efficacy|-6.8||||0.628|TWO_SIDED|95.0|-42.0|19.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||19.60|-42.0|0.6280
71806947|NCT02207816|143115670|SUPERIORITY||Vaccine efficacy|100.0||||0.4987|TWO_SIDED|95.0|-3779.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-3779|0.4987
71806948|NCT02207816|143115670|SUPERIORITY||Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-4051.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||100.0|-4051|1.0000
71806949|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|-254.6||||0.1025|TWO_SIDED|95.0|-3399.0|32.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||32.50|-3399|0.1025
71806950|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|-398.6||||0.0284|TWO_SIDED|95.0|-4642.0|-3.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||-3.20|-4642|0.0284
71806951|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|36.7||||0.3543|TWO_SIDED|95.0|-78.8|79.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||79.20|-78.8|0.3543
71806952|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|3.2||||1|TWO_SIDED|95.0|-151.0|63.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||63.20|-151|1.0000
71806953|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|44.0||||0.3809|TWO_SIDED|95.0|-120.0|88.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||88.00|-120|0.3809
71806954|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|39.1||||0.549|TWO_SIDED|95.0|-140.0|86.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group).||86.90|-140|0.5490
71806955|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|-46.3||||0.3239|TWO_SIDED|95.0|-249.0|36.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||36.20|-249|0.3239
71806956|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|47.6||||0.2184|TWO_SIDED|95.0|-54.5|84.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||84.10|-54.5|0.2184
71806957|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|-116.8||||0.0724|TWO_SIDED|95.0|-476.0|10.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||10.30|-476|0.0724
71806958|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|-81.0||||0.2055|TWO_SIDED|95.0|-393.0|27.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||27.90|-393|0.2055
71806959|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|-18.4||||0.8138|TWO_SIDED|95.0|-245.0|57.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||57.90|-245|0.8138
71806960|NCT02207816|143115671|SUPERIORITY||Vaccine efficacy|24.4||||0.7887|TWO_SIDED|95.0|-148.0|78.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group).||78.40|-148|0.7887
71806961|NCT02207816|143115672|SUPERIORITY||Vaccine efficacy|40.5||||0.0077|TWO_SIDED|95.0|12.84|59.39|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||59.39|12.84|0.0077
71806962|NCT02207816|143115672|SUPERIORITY||Vaccine efficacy|-4.52||||0.7922|TWO_SIDED|95.0|-45.3|24.8|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||24.80|-45.3|0.7922
71806963|NCT02207816|143115672|SUPERIORITY||Vaccine efficacy|29.03||||0.0802|TWO_SIDED|95.0|-4.22|51.67|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||51.67|-4.22|0.0802
71806964|NCT02207816|143115672|SUPERIORITY||Vaccine efficacy|33.87||||0.0387|TWO_SIDED|95.0|2.13|55.32|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||55.32|2.13|0.0387
71806965|NCT02207816|143115673|SUPERIORITY||Vaccine efficacy|36.69||||0.0028|TWO_SIDED|95.0|14.6|53.07|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||53.07|14.60|0.0028
71806966|NCT02207816|143115673|SUPERIORITY||Vaccine efficacy|10.14||||0.443|TWO_SIDED|95.0|-18.1|31.64|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||31.64|-18.1|0.4430
71806967|NCT02207816|143115673|SUPERIORITY||Vaccine efficacy|30.99||||0.0245|TWO_SIDED|95.0|4.67|50.04|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||50.04|4.67|0.0245
71806968|NCT02207816|143115673|SUPERIORITY||Vaccine efficacy|34.24||||0.0122|TWO_SIDED|95.0|8.74|52.61|||Negative binomial regression|Mixed model without random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||52.61|8.74|0.0122
71806969|NCT02207816|143115674|SUPERIORITY||Vaccine efficacy|23.67|||<|0.0001|TWO_SIDED|95.0|15.93|30.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||30.71|15.93|<.0001
71806970|NCT02207816|143115674|SUPERIORITY||Vaccine efficacy|19.15|||<|0.0001|TWO_SIDED|95.0|10.81|26.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[5-17M\] Group over the total number of events/follow-up time in the VeroRab Comparator \[5-17M\] Group).||26.71|10.81|<.0001
71806971|NCT02207816|143115674|SUPERIORITY||Vaccine efficacy|15.55||||0.0009|TWO_SIDED|95.0|6.72|23.54|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||23.54|6.72|0.0009
71806972|NCT02207816|143115674|SUPERIORITY||Vaccine efficacy|13.15||||0.0056|TWO_SIDED|95.0|4.05|21.39|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect \[Lievens, 2011\].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator \[6-12W\] Group over the total number of events/follow-up time in the Menjugate Comparator \[6-12W\] Group).||21.39|4.05|0.0056
71806973|NCT02207816|143115675|SUPERIORITY||Vaccine efficacy|35.5||||0.0053|TWO_SIDED|95.0|10.0|54.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.00|10.00|0.0053
71842583|NCT04163991|143196954|SUPERIORITY||Ratio of geometric mean versus placebo|0.77||||0.2794|TWO_SIDED|90.0|0.52|1.14||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||1.14|0.52|0.2794
71676126|NCT04075682|142870115|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|1.34||0.17|TWO_SIDED|95.0|-0.78|4.48||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.48|-0.78|0.17
71676127|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.58||0.45|TWO_SIDED|95.0|-0.69|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.57|-0.69|0.45
71676128|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.58||0.41|TWO_SIDED|95.0|-1.61|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-1.61|0.41
71676129|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.44|STANDARD_ERROR_OF_MEAN|0.84||0.08|TWO_SIDED|95.0|-3.08|0.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.20|-3.08|0.08
71676130|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.82||0.52|TWO_SIDED|95.0|-2.14|1.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.09|-2.14|0.52
71806974|NCT02207816|143115675|SUPERIORITY||Vaccine efficacy|11.7||||0.4255|TWO_SIDED|95.0|-20.0|35.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||35.20|-20.0|0.4255
71806975|NCT02207816|143115675|SUPERIORITY||Vaccine efficacy|29.2||||0.0479|TWO_SIDED|95.0|-2.4|51.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||51.40|-2.40|0.0479
71806976|NCT02207816|143115675|SUPERIORITY||Vaccine efficacy|18.1||||0.2346|TWO_SIDED|95.0|-16.9|42.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||42.80|-16.9|0.2346
71806977|NCT02207816|143115676|SUPERIORITY||Vaccine efficacy|35.9||||0.0051|TWO_SIDED|95.0|10.3|54.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||54.40|10.30|0.0051
71806978|NCT02207816|143115676|SUPERIORITY||Vaccine efficacy|14.0||||0.334|TWO_SIDED|95.0|-17.3|37.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||37.10|-17.3|0.3340
71806979|NCT02207816|143115676|SUPERIORITY||Vaccine efficacy|28.5||||0.0511|TWO_SIDED|95.0|-2.9|50.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||50.50|-2.90|0.0511
71676131|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|1.11||0.75|TWO_SIDED|95.0|-1.82|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.51|-1.82|0.75
71676132|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.74|STANDARD_ERROR_OF_MEAN|1.57||0.64|TWO_SIDED|95.0|-3.82|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.33|-3.82|0.64
71806980|NCT02207816|143115676|SUPERIORITY||Vaccine efficacy|20.3||||0.1729|TWO_SIDED|95.0|-13.5|44.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Meenjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||44.20|-13.5|0.1729
71806981|NCT02207816|143115679|SUPERIORITY||Vaccine efficacy|50.1||||0.6244|TWO_SIDED|95.0|-859.0|99.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||99.20|-859|0.6244
71806982|NCT02207816|143115679|SUPERIORITY||Vaccine efficacy|-5.7||||1|TWO_SIDED|95.0|-1358.0|92.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group) over the entire follow-up period (from Year 0 to Year 3).||92.30|-1358|1.0000
71806983|NCT02207816|143115679|SUPERIORITY||Vaccine efficacy|-188.9||||0.6244|TWO_SIDED|95.0|-15000.0|76.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||76.80|-15000|0.6244
71806984|NCT02207816|143115679|SUPERIORITY||Vaccine efficacy|3.1||||1|TWO_SIDED|95.0|-7509.0|98.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group) over the entire follow-up period (from Year 0 to Year 3).||98.80|-7509|1.0000
71806985|NCT02207816|143115680|SUPERIORITY||Vaccine efficacy|-98.8||||0.6869|TWO_SIDED|95.0|-2098.0|71.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||71.50|-2098|0.6869
71806986|NCT02207816|143115680|SUPERIORITY||Vaccine efficacy|-406.0||||0.0213|TWO_SIDED|95.0|-4650.0|-7.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||-7.80|-4650|0.0213
71806987|NCT02207816|143115681|SUPERIORITY||Vaccine efficacy|-98.8||||1|TWO_SIDED|95.0|-12000.0|89.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||89.60|-12000|1.0000
71806988|NCT02207816|143115681|SUPERIORITY||Vaccine efficacy|-304.8||||0.2154|TWO_SIDED|95.0|-20000.0|59.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||59.90|-20000|0.2154
71806989|NCT02207816|143115682|SUPERIORITY||Vaccine efficacy|-24.3||||1|TWO_SIDED|95.0|-526.0|73.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||73.30|-526|1.0000
71806990|NCT02207816|143115682|SUPERIORITY||Vaccine efficacy|-77.1||||0.3834|TWO_SIDED|95.0|-725.0|55.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[5-17M\] Group over the proportion in VeroRab Comparator \[5-17M\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||55.00|-725|0.3834
71806991|NCT02207816|143115682|SUPERIORITY||Vaccine efficacy|-297.5||||0.374|TWO_SIDED|95.0|-19000.0|60.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||60.70|-19000|0.3740
71842584|NCT04163991|143196954|SUPERIORITY||Ratio of geometric mean versus placebo|0.57||||0.0199|TWO_SIDED|90.0|0.39|0.85||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.85|0.39|0.0199
71806992|NCT02207816|143115682|SUPERIORITY||Vaccine efficacy|-498.1||||0.124|TWO_SIDED|95.0|-27000.0|27.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator \[6-12W\] Group over the proportion in Menjugate Comparator \[6-12W\] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).||27.40|-27000|0.1240
71806993|NCT01227681|143115710|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||Null hypothesis: there is significant deterioration of UPDRS part III scores from baseline to post G-CSF injection one year||||0.64
71806994|NCT02239679|143115711|SUPERIORITY|||||||0.0166|||||||ANCOVA|||||||0.0166
71806995|NCT02239679|143115717|SUPERIORITY|||||||0.0102||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0102
71806996|NCT02239679|143115717|SUPERIORITY|||||||0.0089||||||no adjustment for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0089
71806997|NCT02239679|143115718|SUPERIORITY|||||||0.0004||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site||||||0.0004
71806998|NCT02239679|143115718|SUPERIORITY||||||<|0.0001||||||no adjustment for multiple comparison|Cochran-Mantel-Haenszel|stratified by site||||||<0.0001
71842585|NCT04163991|143196955|SUPERIORITY||Ratio of geometric mean versus placebo|0.64||||0.0007|TWO_SIDED|90.0|0.52|0.79||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.79|0.52|0.0007
71842586|NCT04163991|143196955|SUPERIORITY||Ratio of geometric mean versus placebo|0.62||||0.0003|TWO_SIDED|90.0|0.5|0.76||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.76|0.50|0.0003
71842587|NCT04163991|143196955|SUPERIORITY||Ratio of geometric mean versus placebo|0.6||||0.0001|TWO_SIDED|90.0|0.48|0.74||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.74|0.48|0.0001
71842588|NCT04163991|143196955|SUPERIORITY||Ratio of geometric mean versus placebo|0.47|||<|0.0001|TWO_SIDED|90.0|0.38|0.59||Results are from MMRM analysis on log(ratio to baseline) with treatment, visit, visit by treatment interaction, and log(baseline) included in the model.|MMRM||Ratio of geometric mean is for VIB4920:placebo. Ratios less than 1 indicate a decrease.|||0.59|0.38|< 0.0001
71842589|NCT04163991|143196956|SUPERIORITY||Odds Ratio (OR)|1.4||||0.775|TWO_SIDED|90.0|0.2|8.0||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||8.0|0.2|0.7750
71842590|NCT04163991|143196956|SUPERIORITY||Odds Ratio (OR)|0.6||||0.6974|TWO_SIDED|90.0|0.1|5.5||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||(Lower limit of 90% CI is \< 0.1.) Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.5|0.1|0.6974
71842591|NCT04163991|143196956|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9318|TWO_SIDED|90.0|0.1|5.7||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.7|0.1|0.9318
71842592|NCT04163991|143196956|SUPERIORITY||Odds Ratio (OR)|0.9||||0.9108|TWO_SIDED|90.0|0.2|5.1||Results are from logistic regression analysis with treatment and baseline DAS28-CRP score included in the model.|Regression, Logistic||Odds ratio is VIB4920/placebo, with associated 90% CI and p-value. Odds ratios greater than 1 favor VIB4920.|||5.1|0.2|0.9108
71842593|NCT04163991|143196957|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
71842594|NCT04163991|143196957|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
71842595|NCT04163991|143196957|SUPERIORITY||Hazard Ratio (HR)|3.01||||0.3407|TWO_SIDED|90.0|0.45|20.09||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||20.09|0.45|0.3407
71842596|NCT04163991|143196957|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9805|TWO_SIDED|90.0|0.1|10.6||Based on Cox regression method with treatment group included in the model.|Regression, Cox||Hazard ratio is VIB4920/placebo. Hazard ratios less than 1 favor VIB4920.|||10.60|0.10|0.9805
71842597|NCT05525104|143197010|SUPERIORITY|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||||||0.041
71842598|NCT05525104|143197011|SUPERIORITY|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
71842599|NCT05525104|143197015|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71806999|NCT01217073|143115780|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.71|||<|0.001|TWO_SIDED|95.0|-0.93|-0.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.50|-0.93|<0.001
71894508|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.35|1.46||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.46|0.35|
71807000|NCT01217073|143115780|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.67|||<|0.001|TWO_SIDED|95.0|-0.88|-0.45||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.45|-0.88|<0.001
71807001|NCT01217073|143115780|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.49|||<|0.001|TWO_SIDED|95.0|-0.7|-0.27||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.27|-0.70|<0.001
71807002|NCT01217073|143115780|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.5|||<|0.001|TWO_SIDED|95.0|-0.71|-0.28||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.28|-0.71|<0.001
71842600|NCT03990883|143197016|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.37|||<|0.0001|TWO_SIDED|95.0|-2.96|3.7|||McNemar|||||3.7|-2.96|<0.0001
71842601|NCT03990883|143197017|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|0.0|||<|0.0001|TWO_SIDED|95.0|-3.71|3.71||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.71|-3.71|<0.0001
71842602|NCT03990883|143197018|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-2.96||||0.025|TWO_SIDED|95.0|-9.99|4.07||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||4.07|-9.99|0.025
71894509|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|1.0|1.6||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.60|1.00|
71894510|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.68|1.33||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.33|0.68|
71807003|NCT01217073|143115780|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.28||||0.012|TWO_SIDED|95.0|-0.5|-0.06||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-0.06|-0.50|0.012
71807004|NCT01217073|143115781|SUPERIORITY_OR_OTHER||Difference in percentage|6.2|||||TWO_SIDED|95.0|-6.2|18.4||||||||18.4|-6.2|
71807005|NCT01217073|143115781|SUPERIORITY_OR_OTHER||Difference in percentage|12.5|||||TWO_SIDED|95.0|-0.1|24.7||||||||24.7|-0.1|
71807006|NCT01217073|143115781|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-6.5|18.0||||||||18.0|-6.5|
71807007|NCT01217073|143115781|SUPERIORITY_OR_OTHER||Difference in percentage|5.5|||||TWO_SIDED|95.0|-6.8|17.7||||||||17.7|-6.8|
71807008|NCT01217073|143115781|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-9.8|14.5||||||||14.5|-9.8|
71807009|NCT01217073|143115782|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.1||||||||4.1|-4.1|
71807010|NCT01217073|143115782|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
71807011|NCT01217073|143115782|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.1|4.0||||||||4.0|-4.1|
71807012|NCT01217073|143115782|SUPERIORITY_OR_OTHER||Difference in percentage|-0.9|||||TWO_SIDED|95.0|-4.9|2.4||||||||2.4|-4.9|
71807013|NCT01217073|143115782|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-1.7|7.9||||||||7.9|-1.7|
71807014|NCT01217073|143115783|SUPERIORITY_OR_OTHER||Difference in percent|1.0|||||TWO_SIDED|95.0|-9.8|13.1||||||||13.1|-9.8|
71807015|NCT01217073|143115784|SUPERIORITY_OR_OTHER||Difference in percent|-1.4|||||TWO_SIDED|95.0|-9.1|2.6||||||||2.6|-9.1|
71807016|NCT01217073|143115785|SUPERIORITY_OR_OTHER||Difference in least squares mean|-44.9|||<|0.001|TWO_SIDED|95.0|-59.0|-30.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-30.7|-59.0|<0.001
71807017|NCT01217073|143115785|SUPERIORITY_OR_OTHER||Difference in least squares mean|-41.6|||<|0.001|TWO_SIDED|95.0|-55.3|-27.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-27.8|-55.3|<0.001
71676133|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.18||0.91|TWO_SIDED|95.0|-2.17|2.45||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.45|-2.17|0.91
71676134|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|1.25||0.5|TWO_SIDED|95.0|-3.29|1.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.60|-3.29|0.50
71676135|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.14|STANDARD_ERROR_OF_MEAN|1.16||0.007|TWO_SIDED|95.0|0.86|5.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.41|0.86|0.007
71676136|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.09|STANDARD_ERROR_OF_MEAN|1.69||0.52|TWO_SIDED|95.0|-2.22|4.4||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.40|-2.22|0.52
71676137|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|1.82||0.86|TWO_SIDED|95.0|-3.89|3.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.23|-3.89|0.86
71807018|NCT01217073|143115785|SUPERIORITY_OR_OTHER||Difference in least squares mean|-35.1|||<|0.001|TWO_SIDED|95.0|-48.9|-21.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-21.3|-48.9|<0.001
71807019|NCT01217073|143115785|SUPERIORITY_OR_OTHER||Difference in least squares mean|-33.5|||<|0.001||95.0|-47.3|-19.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-19.7|-47.3|<0.001
71807020|NCT01217073|143115785|SUPERIORITY_OR_OTHER||Difference in least squares mean|-18.8||||0.009|TWO_SIDED|95.0|-32.9|-4.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-4.8|-32.9|0.009
71807021|NCT01217073|143115786|SUPERIORITY_OR_OTHER||Difference in least squares mean|-21.4|||<|0.001|TWO_SIDED|95.0|-29.4|-13.4||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-13.4|-29.4|<0.001
71807022|NCT01217073|143115786|SUPERIORITY_OR_OTHER||Difference in least squares mean|-13.5|||<|0.001|TWO_SIDED|95.0|-21.3|-5.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-5.7|-21.3|<0.001
71842603|NCT03990883|143197019|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45||||0.009|TWO_SIDED|95.0|-8.42|7.52||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||7.52|-8.42|0.009
71842604|NCT03990883|143197020|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.37|||<|0.0001|TWO_SIDED|95.0|-3.85|3.11||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.11|-3.85|<0.0001
71894511|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.82|1.31||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.82|
71894512|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.24|1.04||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.04|0.24|
71894513|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|0.58|2.53||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.53|0.58|
71894514|NCT01193335|143310988|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.52|1.37||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.52|
71677329|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.254|||||TWO_SIDED|95.0|0.17|0.381||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.381|0.170|
71894515|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.45|0.97||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.45|
71894516|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.54|1.4||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.40|0.54|
71894517|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.31||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.41|
71894518|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.14||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.54|
71894519|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.34|0.87||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.87|0.34|
71894520|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.31|1.1||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.10|0.31|
71676138|NCT04075682|142870116|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|1.68||0.61|TWO_SIDED|95.0|-4.15|2.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.43|-4.15|0.61
71676139|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.26|STANDARD_ERROR_OF_MEAN|0.28||0.29|TWO_SIDED|95.0|0.82|1.96||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.96|0.82|0.29
71807023|NCT01217073|143115786|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.3|||<|0.001|TWO_SIDED|95.0|-22.2|-6.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-6.3|-22.2|<0.001
71807024|NCT01217073|143115786|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.0|||<|0.001|TWO_SIDED|95.0|-26.9|-11.2||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||-11.2|-26.9|<0.001
71807025|NCT01217073|143115786|SUPERIORITY_OR_OTHER||Difference in least squares mean|-2.5||||0.539|TWO_SIDED|95.0|-10.4|5.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis|||||5.5|-10.4|0.539
71807026|NCT00373334|143115827|SUPERIORITY_OR_OTHER|||||||0.528||95.0|||||Cochran-Mantel-Haenszel|||||||0.528
71807027|NCT00373334|143115827|SUPERIORITY_OR_OTHER|||||||0.341||95.0|||||Cochran-Mantel-Haenszel|||||||0.341
71807028|NCT00373334|143115828|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.746
71807029|NCT00373334|143115828|SUPERIORITY_OR_OTHER|||||||0.262||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.262
71807030|NCT00373334|143115829|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.609
71807031|NCT00373334|143115829|SUPERIORITY_OR_OTHER|||||||0.938||95.0|||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).||||0.938
71807032|NCT03317977|143115961|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
71807033|NCT03998618|143115969|SUPERIORITY||partial correlation|0.12||||0.018|TWO_SIDED|95.0|-0.01|0.25||P-value for study group x time interaction. Two-tailed p-values \<.05 were considered statistically significant.|Mixed Models Analysis|degrees of freedom = 234. multiply imputed data were used in analyses.||||0.25|-0.01|.018
71807034|NCT03998618|143115970|SUPERIORITY||partial correlation|0.11||||0.037|TWO_SIDED|95.0|-0.02|0.24||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.24|-0.02|.037
71807035|NCT03998618|143115971|SUPERIORITY||partial correlation|0.07||||0.355|TWO_SIDED|95.0|-0.06|0.2||P-value for study group x time interaction. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance = 0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.20|-0.06|.355
71807036|NCT03998618|143115972|SUPERIORITY||partial correlation|0.08||||0.167|TWO_SIDED|95.0|-0.04|0.21||P-value for study group x time interaction for physical quality of life. Probabilities for the secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.21|-0.04|.167
71807037|NCT03998618|143115972|SUPERIORITY||partial correlation|0.09||||0.105|TWO_SIDED|95.0|-0.03|0.22||P-value for study group x time interaction for social/family quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.03|.105
71807038|NCT03998618|143115972|SUPERIORITY||partial correlation|0.09||||0.142|TWO_SIDED|95.0|-0.04|0.22||P-value for study group x time interaction for emotional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.22|-0.04|.142
71807039|NCT03998618|143115972|SUPERIORITY||partial correlation|0.13||||0.006|TWO_SIDED|95.0|0.01|0.26||P-value for study group x time interaction for functional quality of life. Probabilities for the six secondary outcomes were Sidak adjusted for correlated multiple outcomes (adjusted probability for significance=0.0085).|Mixed Models Analysis|degrees of freedom = 234. Multiply imputed data were used.||||0.26|0.01|.006
71807040|NCT02415400|143115973|NON_INFERIORITY|Non-Inferiority (NI) margin = 1.2|||||<|0.0001|||||||1-sided p-value for NI test|||Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.||||<0.0001
71807041|NCT02415400|143115973|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint||0.82|0.58|<0.0001
71807042|NCT02415400|143115974|SUPERIORITY||Hazard Ratio (HR)|1.88|||<|0.0001|TWO_SIDED|95.0|1.58|2.23|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.||2.23|1.58|<0.0001
71807043|NCT02415400|143115975|SUPERIORITY||||||<|0.0001|||||||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.||||<0.0001
71807044|NCT02415400|143115976|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0033|TWO_SIDED|95.0|0.75|0.94|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.||0.94|0.75|0.0033
71807045|NCT02415400|143115977|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.2219|TWO_SIDED|95.0|0.96|1.2|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.||1.20|0.96|0.2219
71807046|NCT02415400|143115978|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.437|TWO_SIDED|95.0|0.75|1.13|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.||1.13|0.75|0.4370
71807047|NCT02415400|143115979|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1742|TWO_SIDED|95.0|0.7|1.07|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.||1.07|0.70|0.1742
71807048|NCT02270450|143115980|SUPERIORITY||Mean Difference (Net)|2.87|STANDARD_ERROR_OF_MEAN|4.3||0.5|TWO_SIDED|||||A p-value less than 0.05 is considered statistically significant.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|"A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of good days between patients assigned to surgery and patients assigned to non-surgical management."||||0.50
71807049|NCT02270450|143115981|SUPERIORITY||Mean Difference (Net)|-1.09||||0.64|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the length of the initial hospital stay between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.64
71807050|NCT02270450|143115982|SUPERIORITY||Odds Ratio (OR)|0.82||||0.6|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares NG tube use vs no NG tube use between patients assigned to surgery and patients assigned to non-surgical management.||||0.60
71807051|NCT02270450|143115983|SUPERIORITY||Mean Difference (Net)|0.64||||0.47|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the number of days of NG tube use between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.47
71813600|NCT02305381|143129497|SUPERIORITY_OR_OTHER||Treatment difference|-1.35|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.1|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening \[≤8.0% or \>8.0%\] crossed with use of metformin \[yes or no\]; 2 by 2 levels) as fixed factors and baseline value as covariate||-1.10|-1.61|< 0.0001
71807052|NCT02270450|143115984|SUPERIORITY||Mean Difference (Net)|-4.1||||0.001|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for nausea severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.001
71807053|NCT02270450|143115984|SUPERIORITY||Mean Difference (Net)|-1.63||||0.008|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for vomiting severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.008
71807054|NCT02270450|143115984|SUPERIORITY||Mean Difference (Net)|-1.31||||0.04|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for bloating severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.04
71807055|NCT02270450|143115984|SUPERIORITY||Mean Difference (Net)|-3.6||||0.01|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for pain severity between patients assigned to surgery and patients and patients assigned to non-surgical management. An interaction term between treatment and pathway was included.||||0.01
71807056|NCT02270450|143115984|SUPERIORITY||Mean Difference (Net)|-1.9||||0.007|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Linear|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A linear regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares the MDASI-GI Symptom Assessment score for constipation severity between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.007
71807057|NCT02270450|143115985|SUPERIORITY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|||||For all secondary analyses, p-values should be interpreted cautiously as no adjustments for multiple comparisons were made.|Regression, Logistic|Adjusted for treatment, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A parallel logistic regression model was applied to the combined data from the randomized and Patient Choice (non-randomized) pathways, using the intention to treat principle with a treatment indicator variable (surgical vs non-surgical management) based on assignment. The model compares ability to eat between patients assigned to surgery and patients and patients assigned to non-surgical management.||||0.52
71807058|NCT02270450|143115986|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.12|TWO_SIDED|95.0|0.45|1.09|||Regression, Cox|Adjusted for treatment, pathway, admitting attending physician specialty, Zubrod performance status, baseline albumin, and primary cancer site.|Comparing surgery to non-surgical management.|A Cox proportional hazards regression model stratified by pathway (randomized vs Patient Choice) was used to estimate the effect of treatment assignment (surgery vs non-surgical management) on overall survival.||1.09|0.45|0.12
71807059|NCT02081846|143115994|SUPERIORITY|||||||0.047|||||||Regression, Logistic|||||||0.047
71807060|NCT02081846|143115995|SUPERIORITY|||||||0.32|||||||Regression, Linear|||||||0.32
71807061|NCT02081846|143115996|SUPERIORITY|||||||0.82|||||||censored Poisson model|||||||0.82
71807062|NCT02081846|143115997|SUPERIORITY||||||<|0.01|||||||Poisson model|||||||<0.01
71807063|NCT02081846|143115998|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
71807064|NCT02081846|143115999|SUPERIORITY|||||||0.052|||||||Regression, Logistic|||||||0.052
71807065|NCT02081846|143116000|SUPERIORITY|||||||0.12|||||||Regression, Logistic|||||||0.12
71894521|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.4|1.01||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.01|0.40|
71894522|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.38|0.81||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.81|0.38|
71676140|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.27||0.43|TWO_SIDED|95.0|0.77|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.85|0.77|0.43
71676141|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.37||0.6|TWO_SIDED|95.0|0.63|2.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.20|0.63|0.60
71676142|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.25|STANDARD_ERROR_OF_MEAN|0.4||0.48|TWO_SIDED|95.0|0.67|2.33||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.33|0.67|0.48
71676143|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.8|STANDARD_ERROR_OF_MEAN|0.36||0.62|TWO_SIDED|95.0|0.34|1.91||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.91|0.34|0.62
71676144|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.04|STANDARD_ERROR_OF_MEAN|1.93||0.079|TWO_SIDED|95.0|0.88|10.52||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||10.52|0.88|0.079
71676145|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.95||0.1|TWO_SIDED|95.0|0.87|5.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||5.12|0.87|0.10
71807066|NCT02251990|143116018|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p-value was based on a one-sided asymptotic test for a binomial proportion. A one-sided p-value \<0.0125 was considered supportive of a conclusion that the true SVR12 is \>73%.|one-sided asymptotic test|||A one-sided Wald test was used to test the null hypothesis, which was that the SVR12 rate for the ITG was ≤ the historical reference rate of 73%. The historical reference SVR rate for treatment-naive genotype 1 predominantly Asian participants treated with pegylated interferon/ribavirin was derived from 2 studies (PMCID: PMC417, PMCID: PMC3644280) after adjusting for an expected improved safety profile related to an interferon-free regimen.||||<0.001
71807067|NCT02251990|143116019|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-10.6|9.6||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||9.6|-10.6|
71807068|NCT02251990|143116020|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.5|||||TWO_SIDED|95.0|-4.2|0.9||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.||0.9|-4.2|
71807069|NCT03265600|143116023|SUPERIORITY||Odds Ratio (OR)|2.91||||0.006|TWO_SIDED||||||Unadjusted bivariate logistic regression|||||||0.006
71807070|NCT03265600|143116024|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Cohen's d: -0.25||||||0.19
71807071|NCT03265600|143116025|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Cohen's d: -0.36||||||0.12
71807072|NCT03265600|143116026|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|Cohen's d: -0.34||||||0.08
71807073|NCT03265600|143116027|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.57||||||<0.001
71807074|NCT03265600|143116028|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|Cohen's d: 0.41||||||0.03
71807075|NCT03265600|143116029|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|Cohen's d: 0.15||||||0.31
71807076|NCT03265600|143116030|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Cohen's d: 0.22||||||0.26
71807077|NCT03265600|143116031|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: -0.58||||||<0.001
71807078|NCT03265600|143116032|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.75||||||<0.001
71807079|NCT00295750|143116053|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|1.9||||||97.5|-1.8|5.7||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.7|-1.8|
71807080|NCT00295750|143116053|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|0.9||||||97.5|-3.2|5.0||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone \<=0.5 ng/mL from Day 28 to Day 364.||5.0|-3.2|
71807081|NCT00295750|143116054|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71807082|NCT00295750|143116054|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71807083|NCT00295750|143116055|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71807084|NCT00295750|143116055|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71807085|NCT00295750|143116057|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
71807086|NCT00295750|143116057|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14||||<0.0001
71807087|NCT00295750|143116057|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
71807088|NCT00295750|143116057|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28||||<0.0001
71807089|NCT00295750|143116058|SUPERIORITY_OR_OTHER||Cumulative probability|85.8||||||95.0|79.8|90.1|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.1|79.8|
71807090|NCT00295750|143116058|SUPERIORITY_OR_OTHER||Cumulative probability|91.1||||||95.0|85.9|94.5|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||94.5|85.9|
71807091|NCT00295750|143116058|SUPERIORITY_OR_OTHER||Cumulative probability|85.9||||||95.0|79.9|90.2|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.|||90.2|79.9|
71807092|NCT00936858|143116064|OTHER||6 month PFS probability|0.35|||||TWO_SIDED|||||||||We will declare the trial a success after observing 7 or more patients with PFS within 6 months. The study will have alpha = 0.092 and power =0.970, assuming a 6 month PFS probability of 0.12 for the null and a PFS probability of 0.35 as the alternative hypothesis.||||
71807093|NCT00567242|143116077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2801|STANDARD_ERROR_OF_MEAN|0.1077|<|0.05|ONE_SIDED|95.0||-0.0709|||t-test, 1 sided|||"H1: The Intention Group will show a significant rightward shift in lateral frontal laterality from pre-treatment to post-treatment.~H0: The Intention Group will show no shift in lateral frontal laterality from pre-treatment to post-treatment.~Since this is a repeated measures t test, the data are presented as the mean and standard deviation for for the post-treatment laterality index minus the pre-treatment laterality index."||-0.0709||<.05
71807094|NCT00567242|143116077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1832|STANDARD_ERROR_OF_MEAN|0.2768|<|0.05|ONE_SIDED|95.0||0.3546|||t-test, 1 sided|||"H1: The Control Group will show a significant rightward shift in lateral frontal lateral indices from pre-treatment to post-treatment.~H0: The Control group will show no shift in lateral frontal laterality indices from pre-treatment to post-treatment.~Since the analysis to test these hypotheses is a repeated-measures t-test, the mean and standard deviation are given for post-treatment laterality index minus pre-treatment laterality index."||0.3546||<.05
71807095|NCT00567242|143116078|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|ONE_SIDED|95.0|-1.81||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||-1.81|<.05
71807096|NCT00567242|143116079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.56|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|ONE_SIDED|95.0|0.26||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|||0.26|<.05
71807097|NCT00435370|143116091|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||||||<0.05
71807098|NCT01316926|143116118|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9204|||||TWO_SIDED|90.0|0.8556|0.99|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||0.9900|0.8556|
71807099|NCT01316926|143116119|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.941|||||TWO_SIDED|90.0|0.846|1.0467|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.|||1.0467|0.8460|
71807100|NCT01316926|143116120|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency - ANVISA - upon manufacturing a site change.|Ratio T formulation/R formulation|0.9333|||||TWO_SIDED|90.0|0.8502|1.0246|||||Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.|||1.0246|0.8502|
71807101|NCT00617344|143116126|OTHER|The associated 95% confidence intervals (CIs) for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 1: Pre-injection 1 (Day 0)||2.84|-7.44|
71807102|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-15.5|||||TWO_SIDED|95.0|-28.4|-2.0||||||Dengue Virus Serotype 1: 30 days post-injection 2||-2.00|-28.4|
71807103|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||TWO_SIDED|95.0|-7.44|2.84||||||Dengue Virus Serotype 2: Pre-injection 1 (Day 0)||2.84|-7.44|
71807104|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-3.1|||||TWO_SIDED|95.0|-15.0|8.75||||||Dengue Virus Serotype 2: 30 days post-injection 2||8.75|-15.0|
71807105|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|1.0|||||TWO_SIDED|95.0|-9.09|11.1||||||Dengue Virus Serotype 3: Pre-injection 1 (Day 0)||11.1|-9.09|
71807106|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-5.7|||||TWO_SIDED|95.0|-15.6|3.81||||||Dengue Virus Serotype 3: 30 days post-injection 2||3.81|-15.6|
71807107|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-4.0|||||TWO_SIDED|95.0|-10.9|2.49||||||Dengue Virus Serotype 4: Pre-injection 1 (Day 0)||2.49|-10.9|
71842605|NCT03990883|143197021|NON_INFERIORITY|"The hypothesis to be tested was: H0: pA-pB ≤ d0 versus H1: pA-pB \> d0 where, pA is the response rate for Princess® FILLER Lidocaine, pB is the response rate for the Comparator, and d0 is the non-inferiority margin set at -10%. The hypothesis was tested using a 1-sided, McNemar type test at an alpha of 0.025 with a delta of 0.10 (10%).~Assuming pA to be 87% and pB to be 88% a sample size of 222 subjects had been calculated to be sufficient to achieve a power of 90%."|Risk Difference (RD)|-0.45|||<|0.0001|TWO_SIDED|95.0|-4.05|3.16||The threshold for statistical significance is 0.025. A hierarchical approach is used and results are confirmative if all tests previously performed within the hierarchy achieve significance at a one-sided significance level of 0.025.|McNemar|||||3.16|-4.05|<0.0001
71807108|NCT00617344|143116126|OTHER|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|31.4|||||TWO_SIDED|95.0|18.2|43.2||||||Dengue Virus Serotype 4: 30 days post-injection 2||43.2|18.2|
71807109|NCT02693665|143116151|SUPERIORITY|First measure of congruence was taken at 2 weeks post-baseline for controls, or immediately post-Session 2 for intervention dyads. Analysis presented here assessed differences between groups in agreement. This represents the underlying data without examining the pattern of congruence for each dyad over time. Longitudinal latent class analysis of congruence in responses over time between adolescents/families was conducted at the person not variable level.|Odds Ratio (OR)|3.22|||<|0.05|TWO_SIDED|95.0|1.09|9.57|||longitudinal latent class analysis|examined the pattern of change over time.||"Analysis was at the level of the dyad. AIM 1. To evaluate the efficacy of FACE-TC on patient-family congruence in treatment preferences.~H1a: FACE-TC participants will better maintain congruence over time, compared to controls.~H1b: Development of congruence may not be homogeneous and FACE-TC may influence the pattern of congruence development."||9.57|1.09|<0.05
71807110|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.00743162|||<|0.05|TWO_SIDED|95.0|0.928|1.094||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at baseline comparing intervention and control.||1.094|0.928|<0.05
71842606|NCT03636490|143197046|OTHER|We tested an association between change in urinary sodium excretion rate with stress and ratio of awake-to-asleep urinary sodium excretion rate.|unstandardized B coefficients|0.0021||||0.0032||95.0|0.0007|0.0034|||Regression, Linear|Adjusted for age, sex, race, ethnicity, body mass index, mean DBP during the baseline period, and 24-hour creatinine clearance.||||0.0034|0.0007|0.0032
71842607|NCT03636490|143197047|OTHER|We tested an association between ratio of awake-to-asleep urinary sodium excretion rate and SBP dipping.|unstandardized B coefficients|0.8244||||0.037||95.0|0.0487|1.6|||Regression, Linear|Adjusted for age, sex, race, ethnicity, BMI, smoking, alcohol use, glucose, 24-hr sodium and potassium excretion, 24-hr creat clear, and FENa|Data are unstandardized B coefficients (95% CI)|||1.6000|0.0487|0.037
71676146|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.38|STANDARD_ERROR_OF_MEAN|0.68||0.52|TWO_SIDED|95.0|0.52|3.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.61|0.52|0.52
71677330|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.168|||||TWO_SIDED|95.0|0.112|0.252||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.252|0.112|
71807111|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.05037501|||<|0.05|TWO_SIDED|95.0|0.96438584|1.14403138||The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used.|Mixed Models Analysis|Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment.||Emotional distress-anxiety analysis at 3 months post baseline comparing intervention and control. We hypothesized that anxiety would be lower in the intervention group compared to controls.||1.14403138|0.96438584|<0.05
71807112|NCT02693665|143116152|SUPERIORITY|See earlier comments.|Risk Ratio (RR)|1.01136067|||<|0.05|TWO_SIDED|95.0|0.92887892|1.10116656||See earlier comments.|t-test, 2 sided|See earlier comments.||This is analysis for 6 month outcomes of Emotional-distress - anxiety. See details in 3 month outcomes.||1.10116656|0.92887892|<0.05
71842608|NCT05247034|143197061|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
71842609|NCT05247034|143197061|OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71807113|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.14070431|||<|0.05|TWO_SIDED|95.0|1.04444724|1.2458325|||t-test, 2 sided||See earlier comments.|These are the 12 month outcomes for Emotional distress - anxiety. See earlier comments.||1.24583250|1.04444724|<0.05
71842610|NCT05247034|143197061|OTHER|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||||||0.0125
71842611|NCT05247034|143197062|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||For 1 Hz||||>0.05
71842612|NCT05247034|143197062|OTHER||||||>|0.05|||||||t-test, 2 sided|||5 and 10 Hz||||>0.05
71842613|NCT05247034|143197062|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
71842614|NCT05247034|143197062|OTHER||||||>|0.05|||||||t-test, 2 sided|||For 1, 5 and 10 Hz||||>0.05
71842615|NCT05247034|143197063|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842616|NCT05247034|143197063|OTHER|||||||0.042|||||||Friedman|||||||0.042
71842617|NCT05247034|143197063|OTHER|||||||0.015|||||||Friedman|||||||0.015
71842618|NCT05247034|143197064|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
71842619|NCT05247034|143197064|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
71842620|NCT05247034|143197064|OTHER||||||>|0.05|||||||Z Test|||||||>0.05
71842621|NCT05247034|143197065|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842622|NCT05247034|143197065|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842623|NCT05247034|143197065|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842624|NCT05247034|143197066|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
71842625|NCT05247034|143197066|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842626|NCT05247034|143197066|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842627|NCT05247034|143197067|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
71842628|NCT05247034|143197067|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842629|NCT05247034|143197067|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842630|NCT05247034|143197068|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
71842631|NCT05247034|143197068|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842632|NCT05247034|143197068|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842633|NCT05247034|143197069|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842634|NCT05247034|143197069|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842635|NCT05247034|143197069|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
71842636|NCT05247034|143197070|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842637|NCT05247034|143197070|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71842638|NCT05247034|143197070|OTHER||||||>|0.05|||||||Friedman|||||||>0.05
71842639|NCT05247034|143197071|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71807114|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|0.98078271|||<|0.05|TWO_SIDED|95.0|0.89845609|1.07065301|||t-test, 2 sided|||This analysis is for the outcome Emotional distress - depressive symptoms. We hypothesized that adolescent in the intervention would have lower depressive symptoms compared to controls at 3, 6, and 12 month outcomes. The following are the baseline comparisons between control and intervention which were controlled for in the 3, 6, and 12 month analysis of outcomes.||1.07065301|0.89845609|<0.05
71807115|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.04007715|||<|0.05|TWO_SIDED|95.0|0.94970156|1.13905306|||t-test, 2 sided|||The results here are for the outcome variable Emotional Distress - Depressive symptoms at 3 month outcomes. We hypothesized that adolescents randomized to the intervention would have lower depressive symptoms than controls.||1.13905306|0.94970156|<0.05
71807116|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.07347088|||<|0.05|TWO_SIDED|95.0|0.9806271|1.17510491|||t-test, 2 sided|||We hypothesize that Emotional Distress - Depressive symptoms would be lower in intervention adolescents compared to controls at 6 months post intervention.||1.17510491|0.98062710|<0.05
71807117|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.11582434|||<|0.05|TWO_SIDED|95.0|1.01653156|1.22481585|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have lower scores on Emotional Distress - Depressive symptoms compared to controls at 12 months post baseline.||1.22481585|1.01653156|<0.05
71807118|NCT02693665|143116152|SUPERIORITY||Risk Ratio, log|0.98803061|||<|0.05|TWO_SIDED|95.0|0.89065531|1.09605195|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would have no differences in fatigue at baseline if randomization was successful. In this analysis we examine the baseline results.||1.09605195|0.89065531|<0.05
71807119|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.13509797|||<|0.05|TWO_SIDED|95.0|1.01959639|1.26368376|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention arm would report less Fatigue at 3 months outcome compared to controls.||1.26368376|1.01959639|<0.05
71807120|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.04944737|||<|0.05|TWO_SIDED|95.0|0.94281417|1.16814089|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention would report less Fatigue at 6 months post baseline compared to control adolescents.||1.16814089|0.94281417|<0.05
71807121|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.11042568|||<|0.05|TWO_SIDED|95.0|0.99383841|1.24068981|||t-test, 2 sided|||We hypothesized that intervention adolescents would report less Fatigue than controls at 12 months post baseline.||1.24068981|0.99383841|<0.05
71807122|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|0.9683347|||<|0.05|TWO_SIDED|95.0|0.88658183|1.05762611|||t-test, 2 sided|||We hypothesized that there would be no differences at baseline between intervention and control adolescents with respect to Pain Interference.||1.05762611|0.88658183|<0.05
71807123|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.04450374|||<|0.05|TWO_SIDED|95.0|0.95307464|1.1447037|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 3 months post baseline.||1.14470370|0.95307464|<0.05
71807124|NCT02693665|143116152|SUPERIORITY||Risk Ratio (RR)|1.07182133|||<|0.05|TWO_SIDED|95.0|0.97835451|1.17421748|||t-test, 2 sided|||We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 6 months post baseline.||1.17421748|0.97835451|<0.05
71807125|NCT02693665|143116152|SUPERIORITY||Risk Ratio, log|1.09964781|||<|0.05|TWO_SIDED|95.0|1.00051223|1.20860622|||t-test, 2 sided|||We hypothesized that at 12 month outcome adolescents randomized to the intervention would report less Pain Interference compared to control adolescents.||1.20860622|1.00051223|<0.05
71807126|NCT02693665|143116153|SUPERIORITY||Mean ratio|0.98|||<|0.05|TWO_SIDED|95.0|0.88|1.09|||Mixed Models Analysis|||Meaning and Peace Subscale at 3 months post intervention||1.09|0.88|<0.05
71807127|NCT02693665|143116153|SUPERIORITY||Mean ratio|0.97|||<|0.05|TWO_SIDED|95.0|0.88|1.08|||Mixed Models Analysis|||Meaning and Peace subscale at 6 months post intervention||1.08|0.88|<0.05
71807128|NCT02693665|143116153|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.82|1.02|||Mixed Models Analysis|||Meaning and Peace subscale at 12 months post intervention||1.02|0.82|<0.05
71807129|NCT02693665|143116153|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.73|1.16|||Mixed Models Analysis|||Faith subscale score at 3 months post intervention||1.16|0.73|<0.05
71807130|NCT02693665|143116153|SUPERIORITY||Mean ratio|0.96|||<|0.05|TWO_SIDED|95.0|0.76|1.21|||Mixed Models Analysis|||Faith subscale at 6 months post intervention||1.21|0.76|<0.05
71807131|NCT02693665|143116153|SUPERIORITY||Mean ratio|0.92|||<|0.05|TWO_SIDED|95.0|0.72|1.17|||Mixed Models Analysis|||Faith subscale scores at 12 months post intervention||1.17|0.72|<0.05
71807132|NCT02693665|143116154|SUPERIORITY||Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED|95.0|-0.42|0.15|||GEE model|||Caregiver Strain subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.15|-0.42|<0.05
71807133|NCT02693665|143116154|SUPERIORITY||Mean Difference (Final Values)|0.19|||<|0.05|TWO_SIDED|95.0|0.02|0.36|||GEE model|||Positive Caregiving Appraisal subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.36|0.02|<0.05
71842640|NCT05247034|143197071|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71842641|NCT05247034|143197071|OTHER|||||||0.0027|||||||Wilcoxon (Mann-Whitney)|||||||0.0027
71842642|NCT05247034|143197072|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842643|NCT05247034|143197072|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71842644|NCT05247034|143197072|OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.0430
71842645|NCT05247034|143197073|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842646|NCT05247034|143197073|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71842647|NCT05247034|143197073|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71842648|NCT05247034|143197074|OTHER||||||>|0.05|||||||t-test, 2 sided|||"Comparing row Change from baseline at Week 12"||||>0.05
71842649|NCT05247034|143197074|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71842650|NCT05247034|143197074|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71842651|NCT05247034|143197075|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71807134|NCT02693665|143116154|SUPERIORITY||Mean Difference (Final Values)|-0.01|||<|0.05|TWO_SIDED|95.0|-0.35|0.32|||GEE model|||Caregiver Distress subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||0.32|-0.35|<0.05
71807135|NCT02693665|143116154|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.05|TWO_SIDED|95.0|-0.07|0.38|||GEE model|||Family Well-Being subscale at 3 months post-intervention, comparing intervention to TAU, controlling for baseline levels.||0.38|-0.07|<0.05
71807136|NCT02693665|143116156|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.59||0.47|TWO_SIDED||||||Regression, Linear|Intervention effect for quality of adolescent communication score controlling for age, gender, race, income and on active treatment.|It is the standard error of the slope, but this was not an option.|Quality of communication analysis for adolescents||||0.47
71807137|NCT02693665|143116156|SUPERIORITY||Slope|1.15|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED||||||Regression, Linear|Testing intervention effect for family member quality of communication score controlling for age, gender, race, income nd on active treatment.|This is standard error of the slope.|Quality of communication analysis for family member.||||<0.01
71842652|NCT05247034|143197075|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71894523|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.76|1.17||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.17|0.76|
71842653|NCT05247034|143197075|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71842654|NCT05247034|143197076|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842655|NCT05247034|143197076|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71894524|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.45|0.91||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.45|
71894525|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.47|0.85||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.85|0.47|
71842656|NCT05247034|143197076|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71842657|NCT05247034|143197077|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842658|NCT05247034|143197077|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71842659|NCT05247034|143197077|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71842660|NCT05247034|143197078|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Comparing row Change from baseline at Week 12"||||>0.05
71842661|NCT05247034|143197078|OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||||||0.0007
71842662|NCT05247034|143197078|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71842663|NCT06356285|143197142|EQUIVALENCE|Quasibinominal models were used as the outcomes are bounded count variables. Accepting a two-sided p-value adjusted for 3 comparisons, the study was designed with 80% power to detect a minimal detectable effect size between the trial arms and control for the primary outcome.|Odds Ratio, log|0.05||||0.017|TWO_SIDED|95.0||||A two-sided p-value, as shown in the table, which was adjusted for 3 comparisons|Quasibinominal regression|||||||0.017
71842664|NCT04623775|143197189|SUPERIORITY||Risk Difference (RD)|-6.5|||||TWO_SIDED|95.0|-16.0|3.0||||||||3.0|-16.0|
71842665|NCT04623775|143197190|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|90.0|0.94|2.05|||Cochran-Mantel-Haenszel|||||2.05|0.94|
71842666|NCT05061017|143197224|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
71894526|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.15||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.74|
71894527|NCT01193335|143310989|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.88||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.88|0.52|
71894528|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.35|2.05||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.05|0.35|
71894529|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.41|2.63||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.63|0.41|
71894530|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.22|1.53||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.22|
71676147|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.54|TWO_SIDED|95.0|0.55|3.17||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.17|0.55|0.54
71676148|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.21||0.33|TWO_SIDED|95.0|0.53|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.61|0.53|0.33
71676149|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.53|STANDARD_ERROR_OF_MEAN|1.08||0.55|TWO_SIDED|95.0|0.38|6.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||6.11|0.38|0.55
71676150|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.39||0.44|TWO_SIDED|95.0|0.18|2.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.14|0.18|0.44
71677331|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.436|||||TWO_SIDED|95.0|0.29|0.655||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.655|0.290|
71807138|NCT02693665|143116162|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|0.71|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent positive score comparing intervention with TAU.||||<0.05
71807139|NCT02693665|143116162|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.73|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Adolescent negative worded score comparing intervention to TAU.||||<0.05
71807140|NCT02693665|143116162|SUPERIORITY||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.74|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member positively worded score comparing intervention with treatment as usual.||||<0.05
71807141|NCT02693665|143116162|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.81|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Family member negative worded score comparing intervention to TAU.||||<0.05
71807142|NCT00710424|143116171|SUPERIORITY_OR_OTHER_LEGACY||estimated treatment effect|-0.12||||0.634|TWO_SIDED|95.0|-0.6|0.36|||ANCOVA||A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.|The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.||0.36|-0.60|0.634
71807143|NCT00710424|143116172|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.37|STANDARD_ERROR_OF_MEAN|2.153||0.865|TWO_SIDED|95.0|-3.87|4.61|||ANCOVA|||The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.||4.61|-3.87|0.865
71894531|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.38|1.44||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.44|0.38|
71894532|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.1|0.76||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.76|0.10|
71894533|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.25|1.3||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.30|0.25|
71842667|NCT05061017|143197225|SUPERIORITY|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1.0000
71842668|NCT02938520|143197245|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB - ABC/DTG/3TC) is less than 6%.|Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-2.8|2.1|||||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|2.1|-2.8|
71842669|NCT02938520|143197246|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - ABC/DTG/3TC) is more than -10%|Adjusted difference in proportion|0.4|||||TWO_SIDED|95.0|-3.7|4.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (\<100,000 \>=100,000 c/mL)|||4.5|-3.7|
71842670|NCT02938520|143197299|OTHER||||||<|0.001||||||Week 41/48 was compared with the 1st visit (Week 5) based on Wilcoxon signed-rank test, respectively. p-values are derived for 'Acceptance' only and not adjusted for multiple testing.|Wilcoxon (Mann-Whitney)|||||||<0.001
71842671|NCT02938520|143197301|OTHER||Adjusted difference|1.2||||0.307|TWO_SIDED|95.0|-1.1|3.6|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.6|-1.1|0.307
71894534|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.3|||||TWO_SIDED|95.0|0.11|0.65||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.65|0.11|
71894535|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.32||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.32|0.81|
71894536|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.56|1.37||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.37|0.56|
71894537|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.51|1.23||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.23|0.51|
71894538|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|0.86||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.86|0.17|
71842672|NCT02938520|143197301|OTHER||Adjusted difference|0.9||||0.472|TWO_SIDED|95.0|-1.5|3.2|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.2|-1.5|0.472
71807144|NCT00710424|143116173|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.45||||0.139|TWO_SIDED|95.0|-1.04|0.15|||ANCOVA|||The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.15|-1.04|0.139
71842673|NCT02938520|143197302|OTHER||Adjusted difference|1.8||||0.116|TWO_SIDED|95.0|-0.4|3.9|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.9|-0.4|0.116
71842674|NCT02938520|143197302|OTHER||Adjusted difference|0.1||||0.944|TWO_SIDED|95.0|-2.3|2.5|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.5|-2.3|0.944
71842675|NCT02938520|143197303|OTHER||Adjusted difference|-1.3||||0.552|TWO_SIDED|95.0|-5.7|3.0|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.0|-5.7|0.552
71842676|NCT02938520|143197303|OTHER||Adjusted difference|-4.6||||0.033|TWO_SIDED|95.0|-8.9|-0.4|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||-0.4|-8.9|0.033
71807145|NCT00710424|143116174|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.301||||0.219|TWO_SIDED|95.0|0.855|1.981|||Regression, Logistic|||In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.||1.981|0.855|0.219
71807146|NCT00710424|143116175|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.05||||0.841|TWO_SIDED|95.0|-0.51|0.42|||ANCOVA|||The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.||0.42|-0.51|0.841
71807147|NCT00710424|143116176|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.523|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.||0.03|-0.06|0.523
71807148|NCT00710424|143116177|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.17||||0.41|TWO_SIDED|95.0|-0.59|0.24|||ANCOVA|||The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.||0.24|-0.59|0.410
71807149|NCT00710424|143116180|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.857||||0.521|TWO_SIDED|95.0|0.537|1.37|||Regression, Logistic|||The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.||1.370|0.537|0.521
71842677|NCT02938520|143197304|OTHER||Adjusted difference|1.021||||0.122|TWO_SIDED|95.0|-0.275|2.318|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.318|-0.275|0.122
71842678|NCT02938520|143197304|OTHER||Adjusted difference|1.103||||0.109|TWO_SIDED|95.0|-0.248|2.453|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||2.453|-0.248|0.109
71842679|NCT02938520|143197304|OTHER||Adjusted difference|0.182||||0.645|TWO_SIDED|95.0|-0.594|0.958|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.958|-0.594|0.645
71842680|NCT02938520|143197304|OTHER||Adjusted difference|-0.169||||0.689|TWO_SIDED|95.0|-0.994|0.657|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||0.657|-0.994|0.689
71842681|NCT02938520|143197305|OTHER||Adjusted difference|2.2|||<|0.001|TWO_SIDED|95.0|1.0|3.4|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||3.4|1.0|<0.001
71842682|NCT02938520|143197305|OTHER||Adjusted difference|0.7||||0.217|TWO_SIDED|95.0|-0.4|1.9|||ANCOVA||Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||1.9|-0.4|0.217
71676151|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.28||0.251|TWO_SIDED|95.0|0.84|1.98||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation models for pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.98|0.84|0.2510
71676152|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.27|STANDARD_ERROR_OF_MEAN|0.28||0.2822|TWO_SIDED|95.0|0.82|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.95|0.82|0.2822
71807150|NCT01329029|143116197|SUPERIORITY_OR_OTHER||Rate ratio|0.868|STANDARD_ERROR_OF_MEAN|0.0633||0.0529|TWO_SIDED|95.0|0.753|1.002||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||1.002|0.753|0.0529
71807151|NCT01329029|143116198|SUPERIORITY_OR_OTHER||LS Mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.0089|<|0.0001|TWO_SIDED|95.0|0.038|0.073|||ANCOVA|Analysis of Covariance (ANCOVA) including treatment by time interaction.||||0.073|0.038|<0.0001
71807152|NCT01329029|143116199|SUPERIORITY_OR_OTHER||Rate ratio|0.757|STANDARD_ERROR_OF_MEAN|0.0889||0.0175|TWO_SIDED|95.0|0.601|0.952|||Generalized Linear Regression|Analyzed using a negative binomial regression model excluding a correction for overdispersion.|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|||0.952|0.601|0.0175
71807153|NCT01329029|143116200|SUPERIORITY_OR_OTHER||Rate ratio|0.914|STANDARD_ERROR_OF_MEAN|0.0771||0.2875|TWO_SIDED|95.0|0.775|1.078||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate COPD Exacerbations||1.078|0.775|0.2875
71807154|NCT01329029|143116200|SUPERIORITY_OR_OTHER||Rate Ratio|0.794|STANDARD_ERROR_OF_MEAN|0.0654||0.005|TWO_SIDED|95.0|0.675|0.933||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Mild, Moderate or Severe COPD Exacerbations||0.933|0.675|0.0050
71807155|NCT01329029|143116200|SUPERIORITY_OR_OTHER||Rate ratio|0.854|STANDARD_ERROR_OF_MEAN|0.0605||0.0262|TWO_SIDED|95.0|0.744|0.982||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|COPD Exacerbations treated with Glucocorticosteroids and/or Antibiotics||0.982|0.744|0.0262
71807156|NCT01329029|143116200|SUPERIORITY_OR_OTHER||Rate ratio|0.837|STANDARD_ERROR_OF_MEAN|0.0528||0.0047|TWO_SIDED|95.0|0.739|0.947||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Moderate or Severe COPD Exacerbations and/or treated with Antibiotics||0.947|0.739|0.0047
71807157|NCT01329029|143116200|SUPERIORITY_OR_OTHER||Rate ratio|0.761|STANDARD_ERROR_OF_MEAN|0.0899||0.0209|TWO_SIDED|95.0|0.604|0.96||Level of significance: 5% 2-sided.|Generalized Linear Regression|Negative binomial regression model (estimates of exacerbation rates)|A rate ratio of \< 1 represents a favourable outcome for the test treatment.|Leading to Hospitalisation||0.960|0.604|0.0209
71807158|NCT01329029|143116202|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.917|STANDARD_ERROR_OF_MEAN|0.0549||0.1461|TWO_SIDED|95.0|0.815|1.031||Level of significance: 5% 2-sided.|Cox proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.031|0.815|0.1461
71807159|NCT01329029|143116203|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|STANDARD_ERROR_OF_MEAN|0.0842||0.027|TWO_SIDED|95.0|0.641|0.974||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment|||0.974|0.641|0.0270
71807160|NCT01329029|143116204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749|STANDARD_ERROR_OF_MEAN|0.1209||0.0731|TWO_SIDED|95.0|0.546|1.027||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of \<1 represents a favourable outcome for the test treatment.|||1.027|0.546|0.0731
71807161|NCT01329029|143116205|SUPERIORITY_OR_OTHER||NNTB|9.0|||||TWO_SIDED|95.0|4.0|31.0||||||||31|4|
71807162|NCT01329029|143116208|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.0159|<|0.0001|TWO_SIDED|95.0|0.061|0.124||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and restricted maximum likelihood (REML).||||0.124|0.061|<0.0001
71807163|NCT01329029|143116209|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0062|<|0.0001|TWO_SIDED|95.0|0.013|0.038||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.038|0.013|<0.0001
71894539|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.64|1.97||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.97|0.64|
71842683|NCT02938520|143197306|OTHER||Difference|4.1|||<|0.001|TWO_SIDED|95.0|2.8|5.5|||ANOVA||Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.5|2.8|<0.001
71894540|NCT01193335|143310990|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.27|0.97||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.97|0.27|
71894541|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.33|2.37||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.37|0.33|
71894542|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.37|3.07||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||3.07|0.37|
71842684|NCT02938520|143197308|OTHER||Adjusted difference|2.2||||0.232|TWO_SIDED|95.0|-1.4|5.7|||ANCOVA||Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.7|-1.4|0.232
71842685|NCT02938520|143197308|OTHER||Adjusted difference|2.7||||0.154|TWO_SIDED|95.0|-1.0|6.4|||ANCOVA||Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||6.4|-1.0|0.154
71842686|NCT02938520|143197308|OTHER||Adjusted difference|2.2||||0.236|TWO_SIDED|95.0|-1.4|5.8|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (\<100,000, \>=100,000 c/mL), gender at birth, age (\<50, \>= 50 Years) and race (white, non-white).|||5.8|-1.4|0.236
71842687|NCT06097494|143197310|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|1.01|1.15|||||Calculated as the odds of a person diagnosed with vitiligo having with depression versus people not diagnosed with vitiligo|||1.15|1.01|
71842688|NCT06097494|143197311|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.09|1.3|||||Calculated as the odds of people diagnosed with vitiligo having anxiety compared to people not diagnosed with vitilligo.|||1.30|1.09|
71842689|NCT06097494|143197312|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|1.03|1.17|||||Calculated as the odds of people diagnosed with vitiligo having anxiety or depression compared to people not diagnosed with vitilligo.|||1.17|1.03|
71842690|NCT06097494|143197313|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.26|1.32|||||Adjusted incident rate ratio for increased primary care use was calculated by comparing patients with vitiligo versus matched controls not having vitiligo,using negative binomial regression.|||1.32|1.26|
71894543|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|0.57|5.36||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||5.36|0.57|
71894544|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.38|2.07||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||2.07|0.38|
71894545|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.18|1.21||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.21|0.18|
71894546|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.53||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.53|0.27|
71894547|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.17|1.15||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.15|0.17|
71894548|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.96|1.31||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.31|0.96|
71807164|NCT01329029|143116210|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.094|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.069|0.12||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.120|0.069|<0.0001
71807165|NCT01329029|143116212|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.283|STANDARD_ERROR_OF_MEAN|0.0941||0.0027|TWO_SIDED|95.0|-0.467|-0.098||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||-0.098|-0.467|0.0027
71807166|NCT01329029|143116213|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|0.0439||0.7392|TWO_SIDED|95.0|-0.101|0.071||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.||||0.071|-0.101|0.7392
71807167|NCT01329029|143116216|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.285|STANDARD_ERROR_OF_MEAN|0.2175||0.1909|TWO_SIDED|95.0|-0.711|0.142||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.||||0.142|-0.711|0.1909
71807168|NCT01329029|143116218|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.025|STANDARD_ERROR_OF_MEAN|0.3468||0.9414|TWO_SIDED|95.0|0.528|1.99||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.990|0.528|0.9414
71807169|NCT01329029|143116219|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078|STANDARD_ERROR_OF_MEAN|0.5765||0.8876|TWO_SIDED|95.0|0.378|3.075|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||3.075|0.378|0.8876
71807170|NCT01329029|143116220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.529|STANDARD_ERROR_OF_MEAN|0.1463|<|0.0001|TWO_SIDED|95.0|1.268|1.845|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.845|1.268|<0.0001
71807171|NCT01329029|143116221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695|STANDARD_ERROR_OF_MEAN|0.2691||0.3477|TWO_SIDED|95.0|0.326|1.484||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||1.484|0.326|0.3477
71807172|NCT01329029|143116223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083|STANDARD_ERROR_OF_MEAN|0.3832||0.8208|TWO_SIDED|95.0|0.542|2.167||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of \< 1 represents a lower hazard for the test treatment.|||2.167|0.542|0.8208
71807173|NCT01329029|143116225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977|STANDARD_ERROR_OF_MEAN|0.0865||0.7943|TWO_SIDED|95.0|0.821|1.162||Level of significance: 5% 2-sided.|Cox-proportional hazards model|||||1.162|0.821|0.7943
71807174|NCT02985866|143116244|SUPERIORITY|The first co-primary end point was superiority of CLC over SAP in terms of CGM-measured time below 70 mg/dL. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
71807175|NCT02985866|143116245|NON_INFERIORITY|The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed.|||||<|0.0001||||||To address the issue of multiple comparisons with 2 primary outcomes, the intervention was considered effective only if both co-primary outcomes were statistically significant at 5% level. P value for noninferiority NI (prespecified NI limit = 5%).|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Statistical analyses were performed on an intention-to-treat basis, and all participants with any amount of post randomization data were included in all analyses.||||<0.0001
71807176|NCT02985866|143116246|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71807177|NCT02985866|143116247|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71807178|NCT02985866|143116248|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71807179|NCT02985866|143116249|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71842691|NCT06097494|143197315|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.93|1.2|||||Hazard ratios for mental health referrals was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.20|0.93|
71676153|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.34|STANDARD_ERROR_OF_MEAN|0.42||0.3558|TWO_SIDED|95.0|0.72|2.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for multiple imputation models for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||2.47|0.72|0.3558
71807180|NCT02985866|143116250|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71807181|NCT02985866|143116251|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71807182|NCT02985866|143116252|SUPERIORITY|Same as for primary outcome 1|||||<|0.05||||||All secondary analyses were corrected for multiple comparisons using the false discovery rate at a 10% level for statistical significance. All secondary P values reported are two-sided.|Mixed Models Analysis|The groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect.||Same as for the primary outcomes||||<0.05
71807183|NCT02811861|143116253|SUPERIORITY||Stratified Hazard Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.8|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.80|0.53|<0.0001
71807184|NCT02811861|143116253|SUPERIORITY||Stratified Hazard Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.32|0.49|||Stratified Log-rank Test|Hazard ratio is based on a Cox Proportional Hazards Model including treatment group as a factor.||||0.49|0.32|<0.0001
71807185|NCT02701985|143116337|OTHER||Difference in Response Rates|4.27||||0.7955|TWO_SIDED|95.0|-20.55|29.08|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 3 point reduction from baseline in ESSDAI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% confidence interval (CI) are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||29.08|-20.55|0.7955
71807186|NCT02701985|143116338|OTHER||Difference in Response Rates|1.14||||0.9877|TWO_SIDED|95.0|-23.92|26.19|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 1 point reduction from baseline in ESSPRI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% CI are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.||26.19|-23.92|0.9877
71807187|NCT02701985|143116339|SUPERIORITY||Difference in Adjusted Means|-0.13||||0.8905|TWO_SIDED|95.0|-2.04|1.78|||Mixed Model for Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||1.78|-2.04|0.8905
71807188|NCT02701985|143116340|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.6077|TWO_SIDED|95.0|-1.08|0.64|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.64|-1.08|0.6077
71807189|NCT02701985|143116341|SUPERIORITY||Difference in Adjusted Means|-2.06||||0.2846||95.0|-5.87|1.75|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||1.75|-5.87|0.2846
71807190|NCT02701985|143116342|SUPERIORITY||Difference in Adjusted Means|-0.33||||0.8134||95.0|-2.43|3.08|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable||3.08|-2.43|0.8134
71807191|NCT02701985|143116346|SUPERIORITY||Median Difference (Final Values)|0.87||||0.4266||95.0|-1.3|3.03|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||3.03|-1.30|0.4266
71807192|NCT02701985|143116347|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6429||95.0|-0.21|0.34|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.||0.34|-0.21|0.6429
71842692|NCT06097494|143197316|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.76|1.15|||||Hazard ratios for unemployment was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.15|0.76|
71807193|NCT01640808|143116357|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.351|TWO_SIDED|95.0|0.72|1.124||A two-sided significance level was set at 0.05. Adjustment of multiplicity considering interim analysis is conducted by the Lan DeMets' method of α consumption function.|Log Rank|||||1.124|0.720|0.351
71807194|NCT01640808|143116358|SUPERIORITY||Hazard Ratio (HR)|0.875||||0.222|TWO_SIDED|95.0|0.706|1.085||A two-sided significance level was set at 0.05.|Log Rank|||||1.085|0.706|0.222
71807195|NCT01640808|143116359|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.279|TWO_SIDED|95.0|0.703|1.108||A two-sided significance level was set at 0.05.|Log Rank|||||1.108|0.703|0.279
71807196|NCT01270347|143116365|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the LS mean difference 95% CI for relative change from Baseline to Day 28 in FEV1 percent predicted was \> -4%.|LSMean difference|1.86||||0.1481|TWO_SIDED|95.0|-0.66|4.39|||ANCOVA||Estimates were determined from an analysis of covariance model with terms for treatment, region (US, non-US), and age (12 to 18 years, \> 18 years), and Baseline FEV1 (\< 55%, . 55%).|||4.39|-0.66|0.1481
71807197|NCT01270347|143116366|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|4.968||||0.083|TWO_SIDED|95.0|-0.653|10.59|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), \& baseline as a covariate.|||10.590|-0.653|0.0830
71842693|NCT06097494|143197317|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.06|1.24|||||Hazard ratios for time off work was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.24|1.06|
71842694|NCT06097494|143197318|OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|1.02|1.31|||||Hazard ratios for sleep disturbance was calculated using Cox proportional hazards regression model and reflect a comparison of the incidence rates between people diagnosed with vitiligo and people not diagnosed with vitiligo.|||1.31|1.02|
71842695|NCT05275556|143197319|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.0002|TWO_SIDED|95.0|0.07|0.23||Threshold for significance is 0.025.|Poisson Regression|||||0.23|0.07|0.0002
71842696|NCT05275556|143197320|NON_INFERIORITY|Non-inferiority margin is -10%.|Mean Difference (Final Values)|-0.06||||0.09|TWO_SIDED|95.0|-0.15|0.03||Threshold for significance is 0.025.|Resampling based|||||0.03|-0.15|0.09
71842697|NCT05275556|143197321|SUPERIORITY||Difference in percentage|5.5||||0.031|TWO_SIDED|95.0|-0.3|11.2|||Cochran-Mantel-Haenszel|Threshold for significance is 0.025.||||11.2|-0.3|0.031
71842698|NCT05275556|143197322|OTHER||rate|0.58|||||TWO_SIDED|||||||||||||
71842699|NCT05275556|143197323|OTHER|2 sided test for differences between arms|Mean Difference (Final Values)|0.58||||0.169|TWO_SIDED||||||Permutation test|||||||0.169
71807198|NCT01270347|143116367|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in FEV1 percent predicted is \> -4%.|LSMean difference|1.57||||0.0945|TWO_SIDED|95.0|-0.272|3.411|||ANCOVA||Estimates are determined from a repeated measures model with terms for treatment, visit, the interaction between treatment group and visit, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline as a covariate.|||3.411|-0.272|0.0945
71807199|NCT01270347|143116370|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Pseudomonas Aeruginosa Sputum Density is \> -4%|LSMean difference|0.44||||0.053|TWO_SIDED|95.0|-0.01|0.88|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline organism log density.|||0.88|-0.01|0.0530
71807200|NCT01270347|143116372|NON_INFERIORITY|Non-inferiority is demonstrated if the lower limit of the LS mean difference 95% CI for relative change from baseline to Day 28 in Respiratory Domain of the CFQ-R is \> -4%|LSMean difference|3.19||||0.0463|TWO_SIDED|95.0|0.05|6.32|||ANCOVA||Estimates are determined from an ANCOVA model with terms for treatment, region (US, non-US), age (12-18 years, \>18 years), baseline FEV1 (\<55%, \>=55%), and baseline value.|||6.32|0.05|0.0463
71807201|NCT06242444|143116377|SUPERIORITY||Adjusted Mean Difference|8.35|STANDARD_ERROR_OF_MEAN|2.465||0.0012|TWO_SIDED|95.0|3.42|13.28|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||13.28|3.42|0.0012
71842700|NCT05275556|143197324|OTHER||||||||||||||||||Descriptive analysis: 52.4 in Colonoscopy (Standard of Care), 59.6 in CAD-e Device|||
71842701|NCT05275556|143197325|SUPERIORITY||Mean Difference (Net)|4.6||||0.0578|TWO_SIDED|95.0|-0.2|9.4||Nominal p-value.|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.4|-0.2|0.0578
71842702|NCT05275556|143197326|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.7813|TWO_SIDED|95.0|-1.5|2.0||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.0|-1.5|0.7813
71842703|NCT05275556|143197327|SUPERIORITY||Least-squares means|0.11|||||TWO_SIDED|95.0|0.05|0.17||||||||0.17|0.05|
71842704|NCT05275556|143197328|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.0004|TWO_SIDED|95.0|3.7|12.9||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||12.9|3.7|0.0004
71842705|NCT05275556|143197329|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1185|TWO_SIDED|95.0|-1.0|9.1||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.1|-1|0.1185
71842706|NCT05275556|143197330|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.0752|TWO_SIDED|95.0|-0.4|9.2||nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||9.2|-0.4|0.0752
71894549|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.41|1.14||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.14|0.41|
71894550|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.49|0.92||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.92|0.49|
71894551|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.4|||||TWO_SIDED|95.0|0.16|1.03||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.03|0.16|
71894552|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.6|||||TWO_SIDED|95.0|0.27|1.48||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||1.48|0.27|
71894553|NCT01193335|143310991|SUPERIORITY_OR_OTHER||GMT Ratio|0.5|||||TWO_SIDED|95.0|0.22|0.91||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.||0.91|0.22|
71807202|NCT06242444|143116378|SUPERIORITY||Adjusted Mean Difference|37.33|STANDARD_ERROR_OF_MEAN|3.217|<|0.0001|TWO_SIDED|95.0|30.9|43.76|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Placebo Control Dentifrice.|||43.76|30.90|<.0001
71807203|NCT06242444|143116379|SUPERIORITY||Adjusted Mean Difference|3.95|STANDARD_ERROR_OF_MEAN|2.462||0.1138|TWO_SIDED|95.0|-0.97|8.87|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.87|-0.97|0.1138
71807204|NCT06242444|143116381|SUPERIORITY||Adjusted Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|3.213||0.493|TWO_SIDED|95.0|-4.21|8.64|||Mixed Models Analysis||Adjusted mean difference was calculated as Test Dentifrice minus Reference Dentifrice.|||8.64|-4.21|0.4930
71807205|NCT06242444|143116385|SUPERIORITY||Adjusted Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|2.462||0.0789|TWO_SIDED|95.0|-0.52|9.32|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||9.32|-0.52|0.0789
71807206|NCT06242444|143116385|SUPERIORITY||Adjusted Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.408||0.2178|TWO_SIDED|95.0|-1.82|7.81|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||7.81|-1.82|0.2178
71807207|NCT06242444|143116386|SUPERIORITY||Adjusted Mean Difference|35.12|STANDARD_ERROR_OF_MEAN|3.213|<|0.0001|TWO_SIDED|95.0|28.69|41.54|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||41.54|28.69|<.0001
71807208|NCT06242444|143116386|SUPERIORITY||Adjusted Mean Difference|27.18|STANDARD_ERROR_OF_MEAN|3.018|<|0.0001|TWO_SIDED|95.0|21.14|33.21|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||33.21|21.14|<.0001
71807209|NCT06242444|143116387|SUPERIORITY||Geometric Mean Ratio|1.73|||<|0.0001|TWO_SIDED|95.0|1.53|1.97|||Mixed Models Analysis|||At 4 hours of intra-oral exposure||1.97|1.53|<.0001
71807210|NCT06242444|143116387|SUPERIORITY||Geometric Mean Ratio|1.59|||<|0.0001|TWO_SIDED|95.0|1.42|1.78|||Mixed Models Analysis|||At 12 hours of intra-oral exposure||1.78|1.42|<.0001
71807211|NCT06242444|143116388|SUPERIORITY||Adjusted Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.0277|<|0.0001|TWO_SIDED|95.0|0.252|0.362|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 4 hours of intra-oral exposure||0.362|0.252|<.0001
71807212|NCT06242444|143116388|SUPERIORITY||Adjusted Mean Difference|0.242|STANDARD_ERROR_OF_MEAN|0.0257|<|0.0001|TWO_SIDED|95.0|0.19|0.293|||Mixed Models Analysis||Adjusted mean difference was calculated as Reference Dentifrice minus Placebo Control Dentifrice.|At 12 hours of intra-oral exposure||0.293|0.190|<.0001
71676154|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.36|STANDARD_ERROR_OF_MEAN|0.43||0.3291|TWO_SIDED|95.0|0.73|2.51||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||2.51|0.73|0.3291
71676155|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.39||0.7818|TWO_SIDED|95.0|0.38|2.09||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||2.09|0.38|0.7818
71676156|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.87|STANDARD_ERROR_OF_MEAN|1.79||0.0912|TWO_SIDED|95.0|0.84|9.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||9.73|0.84|0.0912
71676157|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.94|STANDARD_ERROR_OF_MEAN|0.87||0.1361|TWO_SIDED|95.0|0.81|4.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||4.66|0.81|0.1361
71807213|NCT02195986|143116430|EQUIVALENCE|Bioequivalence was established for the primary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the primary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|-0.0062|||||TWO_SIDED|90.0|-0.1209|0.1084||||||The compound hypothesis to test was: H0: PT -PR \< -.20 or PT -PR \> .20 versus HA : -.20 ≤ PT -PR ≤ .20 Where PT = cure rate of test treatment, and PR = cure rate of reference treatment.||0.1084|-0.1209|
71807214|NCT02195986|143116431|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.3766|||<|0.0001|TWO_SIDED|95.0|0.2743|0.479|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4790|0.2743|<0.0001
71807215|NCT02195986|143116431|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.3542|||<|0.0001|TWO_SIDED|95.0|0.257|0.4514|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.4514|0.2570|<0.0001
71842707|NCT05275556|143197332|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.8194|TWO_SIDED|95.0|-3.2|2.6||Nominal p-value|Cochran-Mantel-Haenszel|||Difference in percentage between both arms is reported. H0: Colonoscopy (Standard of Care) percentage \<= CADe Device percentage (i.e. test of superiority)||2.6|-3.2|0.8194
71807216|NCT02195986|143116432|EQUIVALENCE|Bioequivalence was established for the secondary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the secondary endpoint is contained within \[-0.20, 0.20\], using the per-protocol population.|Difference|0.05|||||TWO_SIDED|90.0|-0.0687|0.1686||||||||0.1686|-0.0687|
71842708|NCT05275556|143197333|OTHER|Test for difference|Incidence Rate Ratio|1.39||||0.0008|TWO_SIDED|95.0|1.14|1.69||Nominal p-value|Exact poisson|||||1.69|1.14|0.0008
71842709|NCT04564209|143197399|SUPERIORITY|||||||0.455|||||||ANOVA|||||||.455
71842710|NCT04564209|143197400|SUPERIORITY|||||||0.415|||||||ANOVA|||||||.415
71842711|NCT04564209|143197401|SUPERIORITY|||||||0.443|||||||ANOVA|||||||.443
71842712|NCT04564209|143197402|SUPERIORITY|||||||0.457|||||||ANOVA|||||||.457
71842713|NCT04564209|143197403|SUPERIORITY|||||||0.099|||||||ANOVA|||||||.099
71842714|NCT04564209|143197404|SUPERIORITY|||||||0.338|||||||ANOVA|||||||.338
71842715|NCT04564209|143197405|SUPERIORITY|||||||0.723|||||||ANOVA|||||||.723
71676158|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.58||0.72|TWO_SIDED|95.0|0.46|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||3.07|0.46|0.7200
71807217|NCT02195986|143116433|SUPERIORITY|Superiority test of test product vs placebo|Difference|0.1387||||0.1092|TWO_SIDED|95.0|-0.028|0.3054|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.3054|-0.0280|0.1092
71807218|NCT02195986|143116433|SUPERIORITY|Superiority test of reference product vs placebo|Difference|0.1196||||0.1805|TWO_SIDED|95.0|-0.0491|0.2883|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p\<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP \> 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.||0.2883|-0.0491|0.1805
71807219|NCT02491671|143116459|SUPERIORITY||Risk Ratio (RR)|1.219||||0.171|TWO_SIDED|95.0|0.891|1.583|||Chi-squared|||||1.583|0.891|0.171
71807220|NCT02491671|143116460|SUPERIORITY||z|0.288|||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Wilcoxon rank-sum (Mann-Whitney) test Unadjusted variance 274999.00 Adjustment for ties --21069.78 Adjusted variance 253929.22 z = 0.288; Prob \> \|z\| = 0.7735"|||||>0.05
71807221|NCT02491671|143116461|SUPERIORITY||Risk Ratio (RR)|1.351||||0.307|TWO_SIDED|95.0|0.657|1.879|||Chi-squared|||||1.879|0.657|0 .307
71807222|NCT00535730|143116463|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio\[concomitant/nonconcomitant\] being \>0.67.||||||0.244||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to that in subjects who receive ZOSTAVAX™ nonconcomitantly||||0.244
71807223|NCT00535730|143116465|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|t-test, 1 sided|The one-sided p-value for testing acceptability for GMFR is computed based on t-test. CI is computed based on the t distribution||The hypothesis was that ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23.||||<0.001
71807224|NCT00535730|143116466|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||"The hypothesis was that the GMT of the PnPs antibody response to serotype 3 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who~receive ZOSTAVAX™ nonconcomitantly."||||<0.001
71807225|NCT00535730|143116467|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 14 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
71842716|NCT04564209|143197407|SUPERIORITY|||||||0.578|||||||t-test, 2 sided|||||||.578
71842717|NCT04564209|143197408|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||.998
71842718|NCT04564209|143197409|SUPERIORITY|||||||0.864|||||||t-test, 2 sided|||||||.864
71842719|NCT04679389|143197410|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71842720|NCT04679389|143197411|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
71842721|NCT04679389|143197412|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
71842722|NCT04679389|143197413|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71842723|NCT04679389|143197416|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
71842724|NCT04679389|143197417|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71842725|NCT04099732|143197418|OTHER||Ratio of geometric means (T/R) %|183.36|||||TWO_SIDED|90.0|164.35|204.56|||||Geometric coefficient of variation (gCV) = 16.5.|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.56|164.35|
71842726|NCT04099732|143197419|OTHER||Ratio of geometric means (T/R) %|174.01|||||TWO_SIDED|90.0|154.73|195.68|||||Geometric coefficient of variation (gCV) = 17.7|Relative bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||195.68|154.73|
71842727|NCT04099732|143197420|OTHER||Ratio of geometric means (T/R) %|119.1|||||TWO_SIDED|90.0|109.84|129.15|||||Geometric coefficient of variation (gCV) = 11.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||129.15|109.84|
71677332|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.541|||||TWO_SIDED|95.0|0.361|0.811||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.811|0.361|
71842728|NCT04099732|143197421|OTHER||Ratio of geometric means (T/R) %|119.2|||||TWO_SIDED|90.0|107.68|131.94|||||Geometric coefficient of variation (gCV) = 13.9.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||131.94|107.68|
71842729|NCT04099732|143197422|OTHER||Ratio of geometric means (T/R) %|186.38|||||TWO_SIDED|90.0|169.7|204.71|||||Geometric coefficient of variation (gCV) = 14.1.|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||204.71|169.70|
71842730|NCT04099732|143197423|OTHER||Ratio of geometric means (T/R) %|120.11|||||TWO_SIDED|90.0|110.78|130.23|||||Geometric coefficient of variation (gCV) = 11.1|Relative Bioavailability. The statistical model was an ANOVA model on the logarithmic scale, considering the effects 'subjects' as random and 'treatment' as fixed.||130.23|110.78|
71842731|NCT05257603|143197424|OTHER||Mean Difference (Net)|4.82|STANDARD_ERROR_OF_MEAN|0.615|<|0.99|TWO_SIDED|95.0|3.24|5.72|||ANOVA|||||5.72|3.24|<0.99
71894554|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.33|5.99||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.99|-6.33|
71807226|NCT00535730|143116468|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 19A at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
71807227|NCT00535730|143116469|NON_INFERIORITY_OR_EQUIVALENCE|The power for the noninferiority hypothesis regarding PnPs antibody titer is \~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio \[concomitant/nonconcomitant\] being \>05.|||||<|0.001||95.0||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.||||<0.001
71807228|NCT05525494|143116476|SUPERIORITY||Adjusted Risk Ratio|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received portal (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
71842732|NCT05257603|143197425|OTHER||||||<|0.29|||||||Chi-squared|||||||<.29
71842733|NCT05257603|143197426|OTHER||||||<|0.99|||||||ANOVA|||A one-way ANOVA was used to compare the mean difference in key presses from time 1 to time 2 between the intervention (RPCW) and Control conditions.||||<0.99
71842734|NCT05257603|143197427|OTHER||||||<|0.45|||||||ANOVA|||||||<0.45
71842735|NCT05257603|143197428|OTHER||||||<|0.1||||||Given the exploratory nature of the analysis we were looking for a trend in improvement in emotion regulation (i.e., p\<.10) following the intervention condition compared to control.|ANOVA|||||||<.10
71842736|NCT05257603|143197429|OTHER||||||<|0.1|||||||ANOVA|||Repeated measure ANOVA was used to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
71842737|NCT05257603|143197430|OTHER||||||<|0.1||||||A priori threshold for a trend set at p\<.10 for condition effect (intervention v control).|ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial. The current pilot RCT was not powered to find significant effects.||||<.10
71842738|NCT05257603|143197431|OTHER||||||<|0.098|||||||ANOVA|||An exploratory repeated measures ANOVA with time (4) as the within-subjects variable and condition (2) as the between-subjects variable was conducted to provide preliminary information for estimating sample sizes needed for a larger Stage II efficacy trial.||||<.098
71894555|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|-4.89|||||TWO_SIDED|95.0|-16.87|5.39||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.39|-16.87|
71894556|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|-6.85|||||TWO_SIDED|95.0|-24.28|10.67||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.67|-24.28|
71894557|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|3.03|||||TWO_SIDED|95.0|-3.68|10.57||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.57|-3.68|
71676159|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.48|STANDARD_ERROR_OF_MEAN|0.66||0.3737|TWO_SIDED|95.0|0.62|3.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.53|0.62|0.3737
71807229|NCT05525494|143116476|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||||Adjusted risk ratio. These results compare arms which received text (any type) reminder/recall messages to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.98|
71807230|NCT05525494|143116476|SUPERIORITY||Adjusted Risk Ratio|1.01|||||TWO_SIDED|95.0|1.0|1.02|||||Adjusted risk ratio. These results compare arms which received pre-appointment reminder/recall messages (portal and text) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.02|1.00|
71807231|NCT05525494|143116476|SUPERIORITY||Adjusted Risk Ratio|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||Adjusted risk ratio. These results compare arms which received a tailored reminder/recall messages based on their responses to a pre-commitment questionnaire (any type) to the arm receiving no reminder/recall messages (control).|Comparing the risk of receiving an influenza vaccination||1.01|0.99|
71807232|NCT00762320|143116491|SUPERIORITY_OR_OTHER||||||=|0.004|||||||t-test, 2 sided|df=4||||||=.004
71807233|NCT00762320|143116496|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|df=7||||||<.001
71807234|NCT00417079|143116613|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.|Log Rank|Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)||The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.||||<0.0001
71807235|NCT00417079|143116614|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
71807236|NCT00417079|143116615|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Chi-squared|||||||0.0005
71807237|NCT00417079|143116616|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61|||<|0.0001|TWO_SIDED|95.0|0.49|0.76|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.76|0.49|<0.0001
71807238|NCT00417079|143116617|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.75||||0.001|TWO_SIDED|95.0|0.63|0.9|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||0.90|0.63|0.0010
71807239|NCT00417079|143116618|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
71807240|NCT00417079|143116619|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.5192|TWO_SIDED|95.0|0.69|1.19|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) \< 1 favours the cabazitaxel group and \> 1 favours the mitoxantrone group.|||1.19|0.69|0.5192
71807241|NCT00417079|143116620|SUPERIORITY_OR_OTHER|||||||0.6286||95.0|||||Chi-squared|||||||0.6286
71807242|NCT02512575|143116624|SUPERIORITY_OR_OTHER||Slope|0.847|STANDARD_ERROR_OF_MEAN|0.0238|||TWO_SIDED|90.0|0.807|0.887||||||||0.887|0.807|
71807243|NCT02512575|143116627|SUPERIORITY_OR_OTHER||Slope|0.93|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.869|0.991||||||||0.991|0.869|
71807244|NCT02512575|143116628|SUPERIORITY_OR_OTHER||Slope|0.917|STANDARD_ERROR_OF_MEAN|0.0364|||TWO_SIDED|90.0|0.856|0.978||||||||0.978|0.856|
71807245|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.03|||||TWO_SIDED|90.0|0.96|1.11||||||||1.11|0.960|
71807246|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.0|||||TWO_SIDED|90.0|0.929|1.08||||||||1.08|0.929|
71807247|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|90.0|0.987|1.14||||||||1.14|0.987|
71807248|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.06|||||TWO_SIDED|95.0|0.983|1.13||||||||1.13|0.983|
71807249|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.07|||||TWO_SIDED|90.0|0.995|1.15||||||||1.15|0.995|
71807250|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.17|||||TWO_SIDED|90.0|1.09|1.25||||||||1.25|1.09|
71807251|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.15|||||TWO_SIDED|90.0|1.07|1.24||||||||1.24|1.07|
71807252|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.2|||||TWO_SIDED|90.0|1.11|1.29||||||||1.29|1.11|
71807253|NCT02512575|143116629|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.19|||||TWO_SIDED|90.0|1.11|1.27||||||||1.27|1.11|
71807254|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.872|1.26||||||||1.26|0.872|
71807255|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.05|||||TWO_SIDED|90.0|0.874|1.26||||||||1.26|0.874|
71807256|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.745|1.1||||||||1.10|0.745|
71807257|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.914|||||TWO_SIDED|90.0|0.762|1.1||||||||1.10|0.762|
71807258|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.876|||||TWO_SIDED|90.0|0.728|1.05||||||||1.05|0.728|
71807259|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.86|||||TWO_SIDED|90.0|0.716|1.03||||||||1.03|0.716|
71807260|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.01|||||TWO_SIDED|90.0|0.842|1.21||||||||1.21|0.842|
71807261|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|1.02|||||TWO_SIDED|90.0|0.846|1.22||||||||1.22|0.846|
71894558|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-6.57|5.88||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.88|-6.57|
71676160|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|1.63||0.1345|TWO_SIDED|95.0|0.75|8.9||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||8.90|0.75|0.1345
71677333|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.783|||||TWO_SIDED|95.0|1.188|2.676||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.676|1.188|
71807262|NCT02512575|143116630|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.687|||||TWO_SIDED|90.0|0.572|0.825||||||||0.825|0.572|
71807263|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.982|||||TWO_SIDED|90.0|0.861|1.12||||||||1.12|0.861|
71807264|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.961||||||90.0|0.846|1.09||||||||1.09|0.846|
71807265|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.942|||||TWO_SIDED|90.0|0.829|1.07||||||||1.07|0.829|
71807266|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.861|||||TWO_SIDED|90.0|0.757|0.979||||||||0.979|0.757|
71807267|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.848|||||TWO_SIDED|90.0|0.745|0.964||||||||0.964|0.745|
71807268|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.927|||||TWO_SIDED|90.0|0.815|1.05||||||||1.05|0.815|
71807269|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.907|||||TWO_SIDED|90.0|0.798|1.03||||||||1.03|0.798|
71807270|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.893|||||TWO_SIDED|90.0|0.784|1.02||||||||1.02|0.784|
71807271|NCT02512575|143116631|SUPERIORITY_OR_OTHER||Ratio (Active Vs Placebo)|0.691||||||90.0|0.608|0.785||||||||0.785|0.608|
71807272|NCT04403698|143116632|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (CTX-I) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||<0.01
71807273|NCT04403698|143116633|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||linear mixed models were used to compare bone turnover markers (PINP) between both treatment groups. These models were performed with an intention to treat approach, where drop-outs were considered as non-responders. The models accounted for repeated measures.||||0.05
71807274|NCT04403698|143116634|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups at week 48||||0.042
71807275|NCT04403698|143116635|SUPERIORITY|||||||0.042|||||||Fisher Exact|||A Fisher's exact test was used to assess differences in patient numbers exceeding reference ranges between both treatment groups.||||0.042
71807276|NCT01022762|143116680|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be shown if the upper limit of the 95% confidence interval was less than 0.4%. This corresponds to a one-sided test with a significance level of 2.5% of the hypothesis.|Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.066||||95.0|-0.115|0.143||The p-value corresponds to one-sided hypotheses of superiority with a significance level of 2.5%.|ANCOVA|ANCOVA model was with treatment, centre as explanatory variables and baseline HbA1c value as covariate.|If non-inferiority of repaglinide alone was shown, a test for superiority would be performed based on FAS. Superiority of repaglinide alone over gliclazide alone would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.|H0: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \>= 0.4%. H1: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment \< 0.4%. Sample size was calculated to achieve a power of at least 85%, assuming an equal change in HbA1c and a common standard deviation of 1.2%.||0.143|-0.115|
71807277|NCT01302119|143116691|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71807278|NCT01302119|143116692|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71807279|NCT01302119|143116693|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71807280|NCT01302119|143116694|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71807281|NCT03336619|143116705|SUPERIORITY|||||||0.3765|||||||Gehan-Wilcoxon|Analysis used a Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.3765
71894559|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|3.45|||||TWO_SIDED|95.0|-3.32|11.91||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.91|-3.32|
71894560|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|1.52|||||TWO_SIDED|95.0|-6.73|9.94||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.94|-6.73|
71807282|NCT03336619|143116706|SUPERIORITY|||||||0.6331|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.6331
71807283|NCT03336619|143116707|SUPERIORITY|||||||0.7382|||||||Fisher Exact|||||||0.7382
71807284|NCT03336619|143116708|SUPERIORITY|||||||0.3236|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset to enrollment and influenza vaccination status.||||||0.3236
71807285|NCT03336619|143116709|SUPERIORITY|||||||0.0483|||||||Gehan-Wilcoxon|Gehan-Wilcoxon test stratified by time from symptom onset at enrollment and influenza vaccination status.||||||0.0483
71807286|NCT02298192|143116733|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.|Treatment Contrast|0.12||||0.012|TWO_SIDED|95.0|-0.04|0.28|||Mixed Models Analysis|||The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D \<0.30%.||0.28|-0.04|0.012
71807287|NCT04951336|143116822|SUPERIORITY||ratio of frequencies|0.04||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
71807288|NCT04951336|143116823|SUPERIORITY||ratio of frequencies|0.06||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
71807289|NCT04951336|143116824|SUPERIORITY||ratio of frequencies|0.7||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
71807290|NCT04951336|143116825|SUPERIORITY||ratio of frequencies|1.68||||0.359|TWO_SIDED||||||Chi-squared, Corrected|||||||0.359
71807291|NCT04951336|143116826|SUPERIORITY|age was included as a covariate||||||0.002||||||Differences were considered statistically significant for p-values \<0.05.|Mixed Models Analysis|F(2,150)=6.374. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"The LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
71807292|NCT04951336|143116827|SUPERIORITY|age was included as a covariate||||||0.002||||||p \< 0.05.|Mixed Models Analysis|F(2,157)=4.286. The analysis was repeated using log-transformed values and the resultant p value was also \< 0.05||"LME analysis compared antibodies between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across four time points (days 3, 14, 28, and 6 months). At baseline, participants with detectable anti-CoV-2 antibodies were deemed previously exposed and those with no or very low anti-CoV-2 Abs previously unexposed. Accordingly, all longitudinal analyses excluded baseline antibody data."||||0.002
71807293|NCT04951336|143116828|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|F(8,325)=1.898. Age was included as a covariate in this analysis.||LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||0.060
71807294|NCT04951336|143116829|SUPERIORITY|LME analysis compared symptoms between two grouping factors, (1) Treatment Group (FoTv vs. Placebo) and (2) Exposure Stratum (previously exposed vs. unexposed), across 5 time points (days 1-5)||||||0.326|||||||Mixed Models Analysis|F(8,309)=1.156. Age was included as a covariate in this analysis.||||||0.326
71807295|NCT00127608|143116831|NON_INFERIORITY|The mean viral load between samples stored in liquid and samples stored dry was compared.|Geometric Mean Ratio|0.33|||<|0.0001|||||||ANOVA|Tukey adjustments were made for all 2 by 2 comparisons.|The Geometric Mean Ratio of the viral load was calculated for dry over liquid storage condition.|||||<0.0001
71807296|NCT00127608|143116832|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle fluid)|Mean Difference (Final Values)|-0.4451||||0.0038||95.0|-0.769|-0.1213|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1213|-0.7690|0.0038
71807297|NCT00127608|143116832|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Papule swab minus Vesicle swab)|Median Difference (Final Values)|-0.432||||0.006|TWO_SIDED|95.0|-0.7605|-0.1035|||ANOVA|Tukey adjustments were made for the comparison.||||-0.1035|-0.7605|0.0060
71807298|NCT00127608|143116832|NON_INFERIORITY_OR_EQUIVALENCE|Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab)|Mean Difference (Final Values)|0.00132||||0.9952|TWO_SIDED|95.0|-0.3171|0.3435|||ANOVA|Tukey adjustments were made for the comparison.||||0.3435|-0.3171|0.9952
71807299|NCT00127608|143116832|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|Geometric mean ratio|0.36|||||TWO_SIDED|95.0|0.17|0.76|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle fluid)||0.76|0.17|
71807300|NCT00127608|143116832|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Papule swab over Vesicle swab)|Geometric mean Ratio|0.37|||||TWO_SIDED|95.0|0.17|0.79|||ANOVA|||Geometric mean ratio of viral load (Papule swab over Vesicle swab)||0.79|0.17|
71807301|NCT00127608|143116832|NON_INFERIORITY_OR_EQUIVALENCE|Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|Geometric mean Ratio|1.0|||||TWO_SIDED|95.0|0.48|2.21|||ANOVA|||Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)||2.21|0.48|
71807302|NCT00506493|143116836|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportions|42.6|STANDARD_ERROR_OF_MEAN|6.3|<|0.01|ONE_SIDED|97.5|30.0|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percent of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest \> 22.1%"|||30.0|<0.01
71842739|NCT05123027|143197432|SUPERIORITY||Risk Ratio (RR)|0.7||||0.399|TWO_SIDED|95.0|0.3|1.62||Threshold for significance: p\< 0.05|Mixed Models Analysis|||The primary outcome was analyzed with a longitudinal mixed effects negative binomial model incorporating the total score at earlier time points as well as 180 days. Fixed effect covariates included baseline score, treatment, days, site, stratum, and an interaction between treatment and days. A random effect was included to account for correlation within each participant.||1.62|0.30|0.399
71807303|NCT00506493|143116837|SUPERIORITY_OR_OTHER_LEGACY||binomial proportions|6.7|||<|0.0001|ONE_SIDED|97.5||14.9|||Fisher Exact|||||14.9||<0.0001
71807304|NCT01760239|143116840|SUPERIORITY||Odds Ratio (OR)|4.51|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<.001
71807305|NCT01760239|143116841|SUPERIORITY||Odds Ratio (OR)|2.36||||0.046|TWO_SIDED||||||Mixed Models Analysis|||||||.046
71807306|NCT01760239|143116842|SUPERIORITY||Odds Ratio (OR)|5.13||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||.001
71807307|NCT00686166|143116844|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Exact binomal test|||||||0.18
71807308|NCT03912259|143116855|SUPERIORITY||Difference in Percentage|22.0|||<|0.0001|TWO_SIDED|95.0|11.37|32.65||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|P-value was derived by the Cochran-Mantel-Haenszel test stratified by baseline disease severity (IGA=3 vs. IGA=4).||||32.65|11.37|<.0001
71807309|NCT02216123|143116883|OTHER||Mean Difference (Final Values)|1.23|||||TWO_SIDED|95.0|-4.161|4.982|||||Confidence interval for the treatment difference was based on the Newcombe method. Percent treatment difference (TQ+CQ-PQ+CQ) has been presented.|||4.982|-4.161|
71807310|NCT02216123|143116885|OTHER||Hazard Ratio (HR)|0.984||||||95.0|0.577|1.678|||||Hazards ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio \<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.678|0.577|
71807311|NCT02216123|143116886|OTHER||Hazard Ratio (HR)|0.815|||||TWO_SIDED|95.0|0.442|1.503|||||Hazard ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio\<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.|||1.503|0.442|
71807312|NCT02131272|143116916|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered fulfilled if the upper bound of the two-sided 95% confidence interval for the difference between detemir and NPH was below or equal to 0.4%. The sample size was set to ensure 80% power for the full analysis set (FAS). However, efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.|Least squares mean difference|0.17||||0.3075|TWO_SIDED|95.0|-0.74|1.09||p value is reported for 1 sided test|Mixed Models Analysis|||HbA1c measurements were analysed with a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.||1.09|-0.74|0.3075
71807313|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-3.0|2.2|||Mixed Models Analysis|||||2.2|-3.0|
71807314|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-2.1|2.9|||Mixed Models Analysis|||||2.9|-2.1|
71807315|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-1.4|5.7|||Mixed Models Analysis|||||5.7|-1.4|
71807316|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-6.2|0.9|||Mixed Models Analysis|||||0.9|-6.2|
71807317|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.78|||TWO_SIDED|95.0|-1.3|5.8|||Mixed Models Analysis|||||5.8|-1.3|
71807318|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-0.7|6.9|||Mixed Models Analysis|||||6.9|-0.7|
71807319|NCT00515502|143116962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||||9.7|-0.1|
71807320|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.844|||TWO_SIDED|95.0|-2.47|0.92|||Mixed Models Analysis|||||0.92|-2.47|
71807321|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.04|STANDARD_ERROR_OF_MEAN|0.798|||TWO_SIDED|95.0|-0.57|2.64|||Mixed Models Analysis|||||2.64|-0.57|
71807322|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|STANDARD_ERROR_OF_MEAN|1.151|||TWO_SIDED|95.0|-0.35|4.26|||Mixed Models Analysis|||||4.26|-0.35|
71807323|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|1.193|||TWO_SIDED|95.0|-4.11|0.67|||Mixed Models Analysis|||||0.67|-4.11|
71807324|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-1.44|3.33|||Mixed Models Analysis|||||3.33|-1.44|
71807325|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.257|||TWO_SIDED|95.0|0.24|5.28|||Mixed Models Analysis|||||5.28|0.24|
71807326|NCT00515502|143116963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.34|7.02|||Mixed Models Analysis|||||7.02|0.34|
71807327|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|-5.0|3.4|||Mixed Models Analysis|||||3.4|-5.0|
71807328|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|2.03|||TWO_SIDED|95.0|-7.6|0.6|||Mixed Models Analysis|||||0.6|-7.6|
71807329|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-2.2|8.7|||Mixed Models Analysis|||||8.7|-2.2|
71807330|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-4.7|7.2|||Mixed Models Analysis|||||7.2|-4.7|
71807331|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-7.7|3.6|||Mixed Models Analysis|||||3.6|-7.7|
71842740|NCT05123027|143197433|SUPERIORITY||Risk Ratio (RR)|1.09||||0.53|TWO_SIDED|95.0|0.83|1.45||Threshold for significance: p\< 0.05|Mixed Models Analysis|||This was modeled similar to the primary outcome, an over dispersed Poisson regression model with fixed effect covariates for treatment arm, treatment days, site, and stratum with an interaction between treatment arm and treatment days. Note that no baseline score covariate was included as all participants will be considered to have achieved 0 steps at baseline. A random intercept was included for each subject to account for repeated measures.||1.45|0.83|0.53
71842741|NCT02624050|143197442|SUPERIORITY||Risk Ratio (RR)|1.0||||0.01|TWO_SIDED|||||Threshold for significance was p\<0.05.|log-binomial regression|||||||0.01
71842742|NCT02624050|143197443|SUPERIORITY||Risk Ratio (RR)|1.0||||0.37|TWO_SIDED|||||Threshold of significance was \<0.05|log binomial regression|||||||0.37
71842743|NCT02624050|143197448|SUPERIORITY|||||||0.277||||||"Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.~Threshold for statistical significance was \<0.05"|Ratio of Geometric Means|This p-value is for 15 min after induction of anesthesia||||||0.277
71842744|NCT05215054|143197453|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.||||||||||||||||Difference of changes from baseline in WSRS score for Gana V versus Sculptra|Non-inferiority will be demonstrated if the upper limit of the two-sided 95%CI of the difference of changes from baseline between test device and control is inferior or equal to 0.5.To assess assay sensitivity, the proportion of responders with Gana V®, defined as improvement of ≥1-grade in the WSRS when compared to D0 pre-injection must be ≥50% at the 6 months visit after baseline.|||
71842745|NCT03279978|143197464|OTHER||Slope|0.7124|STANDARD_ERROR_OF_MEAN|0.0694|||TWO_SIDED|95.0|0.5702|0.8546||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8546|0.5702|
71842746|NCT03279978|143197464|OTHER||Slope|0.5964|STANDARD_ERROR_OF_MEAN|0.0575|||TWO_SIDED|95.0|0.4777|0.7151||||||Dose proportionality for AUC0-24 of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data). In this study AUCtau,1 = AUC0-24|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7151|0.4777|
71894561|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Perecent Difference|-10.82|||||TWO_SIDED|95.0|-25.51|4.34||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.34|-25.51|
71807332|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-11.2|1.6|||Mixed Models Analysis|||||1.6|-11.2|
71807333|NCT00515502|143116964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.9|10.0|||Mixed Models Analysis|||||10.0|-5.9|
71807334|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.902|||TWO_SIDED|95.0|-6.23|1.39|||Mixed Models Analysis|||||1.39|-6.23|
71807335|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.834|||TWO_SIDED|95.0|-5.56|1.79|||Mixed Models Analysis|||||1.79|-5.56|
71807336|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.474|||TWO_SIDED|95.0|-3.82|6.07|||Mixed Models Analysis|||||6.07|-3.82|
71807337|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|2.697|||TWO_SIDED|95.0|-5.07|5.69|||Mixed Models Analysis|||||5.69|-5.07|
71894562|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|4.65|||||TWO_SIDED|95.0|0.04|11.48||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.48|0.04|
71894563|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|-16.06|||||TWO_SIDED|95.0|-29.15|-2.6||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.60|-29.15|
71894564|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|2.27|||||TWO_SIDED|95.0|-1.96|7.97||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.97|-1.96|
71894565|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|-2.15|||||TWO_SIDED|95.0|-7.55|2.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.10|-7.55|
71894566|NCT01193335|143310992|SUPERIORITY_OR_OTHER||Percent Difference|-1.09|||||TWO_SIDED|95.0|-5.96|3.18||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.18|-5.96|
71807338|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-7.84|2.38|||Mixed Models Analysis|||||2.38|-7.84|
71807339|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|2.898|||TWO_SIDED|95.0|-7.97|3.59|||Mixed Models Analysis|||||3.59|-7.97|
71807340|NCT00515502|143116965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|3.618|||TWO_SIDED|95.0|-6.39|8.02|||Mixed Models Analysis|||||8.02|-6.39|
71807341|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|95.0|-5.1|0.2|||Mixed Models Analysis|||||0.2|-5.1|
71807342|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|-4.6|0.4|||Mixed Models Analysis|||||0.4|-4.6|
71807343|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.67|||TWO_SIDED|95.0|0.0|6.6|||Mixed Models Analysis|||||6.6|-0.0|
71807344|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|95.0|-5.9|1.2|||Mixed Models Analysis|||||1.2|-5.9|
71807345|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|95.0|-3.5|3.3|||Mixed Models Analysis|||||3.3|-3.5|
71842747|NCT03279978|143197465|OTHER||Slope|0.6445|STANDARD_ERROR_OF_MEAN|0.0649|||TWO_SIDED|95.0|0.5124|0.7766||||||Dose proportionality for Cmax of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7766|0.5124|
71842748|NCT03279978|143197465|OTHER||Slope|0.6223|STANDARD_ERROR_OF_MEAN|0.0715|||TWO_SIDED|95.0|0.4747|0.7699||||||Dose proportionality for Cmax of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7699|0.4747|
71842749|NCT03279978|143197466|OTHER||Slope|0.6401|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|95.0|0.4545|0.8258||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.8258|0.4545|
71842750|NCT03279978|143197466|OTHER||Slope|0.5811|STANDARD_ERROR_OF_MEAN|0.0864|||TWO_SIDED|95.0|0.4013|0.7609||||||Dose proportionality for AUCτ,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7609|0.4013|
71842751|NCT03279978|143197467|OTHER||Slope|0.6005|STANDARD_ERROR_OF_MEAN|0.0722|||TWO_SIDED|95.0|0.4534|0.7477||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fasted groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7477|0.4534|
71894567|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-9.08|||||TWO_SIDED|95.0|-25.11|7.49||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.49|-25.11|
71894568|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-5.39|||||TWO_SIDED|95.0|-21.03|10.4||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.40|-21.03|
71894569|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|6.53|||||TWO_SIDED|95.0|-7.16|21.16||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||21.16|-7.16|
71807346|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-3.5|4.1|||Mixed Models Analysis|||||4.1|-3.5|
71807347|NCT00515502|143116966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|1.0|10.4|||Mixed Models Analysis|||||10.4|1.0|
71807348|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|1.051|||TWO_SIDED|95.0|-5.08|-0.87|||Mixed Models Analysis|||||-0.87|-5.08|
71807349|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.006|||TWO_SIDED|95.0|-3.53|0.5|||Mixed Models Analysis|||||0.50|-3.53|
71807350|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_ERROR_OF_MEAN|1.335|||TWO_SIDED|95.0|-0.46|4.88|||Mixed Models Analysis|||||4.88|-0.46|
71807351|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32|STANDARD_ERROR_OF_MEAN|1.409|||TWO_SIDED|95.0|-6.13|-0.5|||Mixed Models Analysis|||||-0.50|-6.13|
71807352|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|1.366|||TWO_SIDED|95.0|-2.38|3.07|||Mixed Models Analysis|||||3.07|-2.38|
71807353|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.514|||TWO_SIDED|95.0|-1.22|4.82|||Mixed Models Analysis|||||4.82|-1.22|
71807354|NCT00515502|143116967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.53|STANDARD_ERROR_OF_MEAN|1.867|||TWO_SIDED|95.0|1.81|9.25|||Mixed Models Analysis|||||9.25|1.81|
71807355|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|3.256|||TWO_SIDED|95.0|-9.82|3.21|||Mixed Models Analysis|||||3.21|-9.82|
71807356|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|3.193|||TWO_SIDED|95.0|-4.7|8.09|||Mixed Models Analysis|||||8.09|-4.70|
71807357|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|4.268|||TWO_SIDED|95.0|-10.06|6.98|||Mixed Models Analysis|||||6.98|-10.06|
71807358|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17|STANDARD_ERROR_OF_MEAN|4.347|||TWO_SIDED|95.0|-13.84|3.5|||Mixed Models Analysis|||||3.50|-13.84|
71807359|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.86|STANDARD_ERROR_OF_MEAN|4.264|||TWO_SIDED|95.0|-6.65|10.37|||Mixed Models Analysis|||||10.37|-6.65|
71807360|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-2.35|16.08|||Mixed Models Analysis|||||16.08|-2.35|
71807361|NCT00515502|143116968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.63|STANDARD_ERROR_OF_MEAN|5.634|||TWO_SIDED|95.0|-7.59|14.85|||Mixed Models Analysis|||||14.85|-7.59|
71807362|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.298|STANDARD_ERROR_OF_MEAN|2.3297|||TWO_SIDED|95.0|-4.961|4.365|||Mixed Models Analysis|||||4.365|-4.961|
71807363|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.066|STANDARD_ERROR_OF_MEAN|2.2776|||TWO_SIDED|95.0|-3.495|5.627|||Mixed Models Analysis|||||5.627|-3.495|
71894570|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-7.88|||||TWO_SIDED|95.0|-20.28|3.35||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.35|-20.28|
71894571|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-10.73|||||TWO_SIDED|95.0|-29.01|8.11||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.11|-29.01|
71894572|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|7.11|||||TWO_SIDED|95.0|-1.52|17.65||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.65|-1.52|
71894573|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-13.37|||||TWO_SIDED|95.0|-29.57|3.31||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.31|-29.57|
71894574|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|8.09|||||TWO_SIDED|95.0|-0.52|17.81||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||17.81|-0.52|
71894575|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-7.38|||||TWO_SIDED|95.0|-22.86|8.29||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.29|-22.86|
71894576|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|0.51|||||TWO_SIDED|95.0|-8.82|10.08||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.08|-8.82|
71894577|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-20.19|||||TWO_SIDED|95.0|-35.45|-3.95||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.95|-35.45|
71807364|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.062|STANDARD_ERROR_OF_MEAN|3.0952|||TWO_SIDED|95.0|-8.247|4.122|||Mixed Models Analysis|||||4.122|-8.247|
71894578|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||||TWO_SIDED|95.0|-8.5|19.06||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.06|-8.50|
71894579|NCT01193335|143310993|SUPERIORITY_OR_OTHER||Percent Difference|-3.14|||||TWO_SIDED|95.0|-17.51|11.13||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.13|-17.51|
71894580|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.59|5.89||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.89|-5.59|
71894581|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.08|||||TWO_SIDED|95.0|-6.81|7.37||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.37|-6.81|
71894582|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|-1.55|||||TWO_SIDED|95.0|-10.87|7.44||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.44|-10.87|
71894583|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-5.94|5.94||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.94|-5.94|
71894584|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|-1.61|||||TWO_SIDED|95.0|-8.66|4.25||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.25|-8.66|
71894585|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|-6.64|||||TWO_SIDED|95.0|-17.93|3.56||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.56|-17.93|
71894586|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.05|||||TWO_SIDED|95.0|-6.74|7.04||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||7.04|-6.74|
71894587|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|-6.48|||||TWO_SIDED|95.0|-16.37|2.75||||||Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||2.75|-16.37|
71894588|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|1.27|||||TWO_SIDED|95.0|-3.37|6.85||||||Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.85|-3.37|
71894589|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|-1.34|||||TWO_SIDED|95.0|-8.36|5.14||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.14|-8.36|
71894590|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.73|5.04||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||5.04|-4.73|
71894591|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
71894592|NCT01193335|143310994|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-4.48|4.55||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.55|-4.48|
71894593|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-7.5|||||TWO_SIDED|95.0|-24.5|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-24.5|
71894594|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-5.9|||||TWO_SIDED|95.0|-23.6|11.8||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||11.8|-23.6|
71894595|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-10.7|||||TWO_SIDED|95.0|-27.6|6.0||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||6.0|-27.6|
71894596|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-17.0|8.4||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||8.4|-17.0|
71894597|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-23.0|||||TWO_SIDED|95.0|-40.0|-4.9||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.9|-40.0|
71894598|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-11.9|||||TWO_SIDED|95.0|-27.4|3.4||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||3.4|-27.4|
71894599|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-28.2|||||TWO_SIDED|95.0|-43.9|-11.0||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-11.0|-43.9|
71807365|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.362|STANDARD_ERROR_OF_MEAN|3.1891|||TWO_SIDED|95.0|-6.003|6.726|||Mixed Models Analysis|||||6.726|-6.003|
71894600|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-0.3|||||TWO_SIDED|95.0|-10.9|10.3||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||10.3|-10.9|
71894601|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-1.2|||||TWO_SIDED|95.0|-17.5|15.1||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.1|-17.5|
71894602|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-10.6|||||TWO_SIDED|95.0|-25.3|4.5||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.5|-25.3|
71894603|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-18.6|||||TWO_SIDED|95.0|-33.3|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-33.3|
71894604|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|2.8|||||TWO_SIDED|95.0|-7.1|13.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.1|-7.1|
71894605|NCT01193335|143310995|SUPERIORITY_OR_OTHER||Percent Difference|-18.5|||||TWO_SIDED|95.0|-33.7|-2.8||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.8|-33.7|
71894606|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-7.9|||||TWO_SIDED|95.0|-25.2|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||9.9|-25.2|
71807366|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|3.1121|||TWO_SIDED|95.0|-6.873|5.554|||Mixed Models Analysis|||||5.554|-6.873|
71807367|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.704|STANDARD_ERROR_OF_MEAN|3.3916|||TWO_SIDED|95.0|-6.064|7.473|||Mixed Models Analysis|||||7.473|-6.064|
71807368|NCT00515502|143116969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.424|STANDARD_ERROR_OF_MEAN|4.2233|||TWO_SIDED|95.0|-10.84|5.993|||Mixed Models Analysis|||||5.993|-10.84|
71894607|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|0.3|||||TWO_SIDED|95.0|-18.5|19.0||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||19.0|-18.5|
71807369|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.542|||TWO_SIDED|95.0|-4.98|5.15|||Mixed Models Analysis|||||5.15|-4.98|
71807370|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|2.507|||TWO_SIDED|95.0|-3.65|6.34|||Mixed Models Analysis|||||6.34|-3.65|
71807371|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|3.182|||TWO_SIDED|95.0|-7.49|5.19|||Mixed Models Analysis|||||5.19|-7.49|
71807372|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|3.296|||TWO_SIDED|95.0|-6.89|6.24|||Mixed Models Analysis|||||6.24|-6.89|
71807373|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|3.279|||TWO_SIDED|95.0|-6.13|6.94|||Mixed Models Analysis|||||6.94|-6.13|
71807374|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-5.34|8.67|||Mixed Models Analysis|||||8.67|-5.34|
71807375|NCT00515502|143116970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|4.087|||TWO_SIDED|95.0|-8.97|7.32|||Mixed Models Analysis|||||7.32|-8.97|
71807376|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.464|STANDARD_ERROR_OF_MEAN|1.9766|||TWO_SIDED|95.0|-2.492|5.419|||Mixed Models Analysis|||||5.419|-2.492|
71807377|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|STANDARD_ERROR_OF_MEAN|1.9457|||TWO_SIDED|95.0|-3.647|4.144|||Mixed Models Analysis|||||4.144|-3.647|
71807378|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.645|STANDARD_ERROR_OF_MEAN|2.5254|||TWO_SIDED|95.0|-7.687|2.396|||Mixed Models Analysis|||||2.396|-7.687|
71807379|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.585|STANDARD_ERROR_OF_MEAN|2.6352|||TWO_SIDED|95.0|-2.671|7.84|||Mixed Models Analysis|||||7.840|-2.671|
71807380|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.121|STANDARD_ERROR_OF_MEAN|2.5993|||TWO_SIDED|95.0|-6.308|4.067|||Mixed Models Analysis|||||4.067|-6.308|
71807381|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.336|STANDARD_ERROR_OF_MEAN|2.8164|||TWO_SIDED|95.0|-7.952|3.28|||Mixed Models Analysis|||||3.280|-7.952|
71807382|NCT00515502|143116971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.3802|||TWO_SIDED|95.0|-11.96|1.504|||Mixed Models Analysis|||||1.504|-11.96|
71807383|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|95.0|-9.7|-0.7|||Mixed Models Analysis|||||-0.7|-9.7|
71807384|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-8.9|-0.3|||Mixed Models Analysis|||||-0.3|-8.9|
71807385|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-13.5|-1.8|||Mixed Models Analysis|||||-1.8|-13.5|
71894608|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|7.3|||||TWO_SIDED|95.0|-12.0|26.2||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||26.2|-12.0|
71894609|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-2.8|||||TWO_SIDED|95.0|-19.1|13.3||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||13.3|-19.1|
71894610|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-17.9|||||TWO_SIDED|95.0|-34.6|-0.3||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-0.3|-34.6|
71894611|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-4.3|||||TWO_SIDED|95.0|-20.6|12.1||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.1|-20.6|
71894612|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-21.1|||||TWO_SIDED|95.0|-37.8|-3.2||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.2|-37.8|
71894613|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|5.6|||||TWO_SIDED|95.0|-2.7|15.2||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||15.2|-2.7|
71894614|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-5.1|||||TWO_SIDED|95.0|-22.0|12.0||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||12.0|-22.0|
71894615|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-14.4|||||TWO_SIDED|95.0|-26.7|-2.4||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-2.4|-26.7|
71894616|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-20.4|||||TWO_SIDED|95.0|-36.8|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-3.0|-36.8|
71894617|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent Difference|-11.3|||||TWO_SIDED|95.0|-26.4|4.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||4.1|-26.4|
71894618|NCT01193335|143310996|SUPERIORITY_OR_OTHER||Percent difference|-21.6|||||TWO_SIDED|95.0|-37.7|-4.6||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.||-4.6|-37.7|
71894619|NCT01733329|143311000|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
71894620|NCT01733329|143311001|SUPERIORITY_OR_OTHER|||||||0.026|||||||Fisher Exact|||||||0.026
71894621|NCT01733329|143311002|SUPERIORITY_OR_OTHER|||||||0.058|||||||Fisher Exact|||||||0.058
71894622|NCT01733329|143311003|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||||||0.007
71894623|NCT01078753|143311006|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.813||||0.009|TWO_SIDED|95.0|0.462|3.163||Desmopressin was considered to be superior to Placebo if the p-value for the comparison was \< 0.05 and the reduction from Baseline in number of wet nights was larger in the FE992026 group than in the Placebo group.|ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||3.163|0.462|0.009
71894624|NCT01078753|143311007|SUPERIORITY_OR_OTHER||Least Squares mean Difference|1.629||||0.018|TWO_SIDED|95.0|0.287|2.972|||ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||2.972|0.287|0.018
71894625|NCT01078753|143311008|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.183||||0.752|TWO_SIDED|95.0|-0.968|1.335|||ANCOVA|Factors in the analysis included Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.||||1.335|-0.968|0.752
71894626|NCT03826914|143311024|SUPERIORITY||Median Difference (Net)|-0.43||||0.042|TWO_SIDED|95.0|-0.846|-0.015||The threshold of significance was P=0.05|Anaylsis of Covariance||Placebo - Cardioflex|The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-0.015|-0.846|0.042
71894627|NCT03826914|143311025|SUPERIORITY||Mean Difference (Final Values)|-6.772||||0.04|TWO_SIDED|95.0|-11.2|-2.24||The threshold of significance was P=0.05|Anaylsis of Covariance|||The primary analysis was conducted using the post-treatment biomarker value, comparing the two groups, and controlling for their baseline values by using analysis of covariance. In this study, the dependent variable was the biomarkers being tested, the controlled independent variable was the treatment given and the uncontrolled variables were the baseline differences between participants.||-2.24|-11.2|0.04
71894628|NCT04334148|143311029|OTHER|||||||0.2|||||||Fisher Exact|||||||0.200
71894629|NCT04334148|143311030|OTHER|||||||1|||||||Regression, Linear|||||||1.0
71894630|NCT04334148|143311031|SUPERIORITY|||||||0.802|||||||Chi-squared|||||||0.802
71894631|NCT05300087|143311034|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for Cmax between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.014|||<|0.0001|TWO_SIDED|90.0|0.947|1.085|||ANOVA|||||1.085|0.947|<0.0001
71676161|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.96|STANDARD_ERROR_OF_MEAN|1.36||0.3318|TWO_SIDED|95.0|0.5|7.67||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||7.67|0.50|0.3318
71676162|NCT04075682|142870117|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.49||0.7017|TWO_SIDED|95.0|0.23|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.70|0.23|0.7017
71676163|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.47|STANDARD_ERROR_OF_MEAN|0.7||0.001|TWO_SIDED|95.0|1.42|4.31||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.31|1.42|0.001
71676164|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.54||0.025|TWO_SIDED|95.0|1.09|3.3||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.30|1.09|0.025
71676165|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.37|STANDARD_ERROR_OF_MEAN|0.56||0.44|TWO_SIDED|95.0|0.62|3.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.06|0.62|0.44
71677334|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.832|||||TWO_SIDED|95.0|0.555|1.246||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.246|0.555|
71807386|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-11.8|1.1|||Mixed Models Analysis|||||1.1|-11.8|
71807387|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-6.1|6.4|||Mixed Models Analysis|||||6.4|-6.1|
71807388|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-6.1|7.5|||Mixed Models Analysis|||||7.5|-6.1|
71807389|NCT00515502|143116972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.29|||TWO_SIDED|95.0|-10.9|6.2|||Mixed Models Analysis|||||6.2|-10.9|
71807390|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-3.6|0.0|||Mixed Models Analysis|||||0.0|-3.6|
71807391|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.0|1.4|||Mixed Models Analysis|||||1.4|-2.0|
71807392|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-3.9|0.8|||Mixed Models Analysis|||||0.8|-3.9|
71807393|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||||1.6|-3.6|
71676166|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.8|STANDARD_ERROR_OF_MEAN|0.73||0.15|TWO_SIDED|95.0|0.81|3.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||3.97|0.81|0.15
71676167|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.19|STANDARD_ERROR_OF_MEAN|0.67||0.76|TWO_SIDED|95.0|0.39|3.58||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.58|0.39|0.76
71807394|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|-3.3|1.7|||Mixed Models Analysis|||||1.7|-3.3|
71807395|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|95.0|-2.0|3.4|||Mixed Models Analysis|||||3.4|-2.0|
71807396|NCT00515502|143116973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-4.1|2.9|||Mixed Models Analysis|||||2.9|-4.1|
71807397|NCT03317002|143116994|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
71807398|NCT03317002|143116994|SUPERIORITY||Ratio|0.08||||0.001|ONE_SIDED|95.0||0.1|||Mixed Models Analysis|||||0.10||0.001
71807399|NCT03317002|143116995|SUPERIORITY||Ratio|0.04|||<|0.001|ONE_SIDED|95.0||0.05|||Mixed Models Analysis|||||0.05||<0.001
71807400|NCT03317002|143116995|SUPERIORITY||Ratio|0.09||||0.001|ONE_SIDED|95.0||0.12|||Mixed Models Analysis|||||0.12||0.001
71807401|NCT05098054|143117022|OTHER||Geometric Least-squares mean(GLSM) Ratio|214.93|||||TWO_SIDED|90.0|103.47|446.45|||||"Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||446.45|103.47|
71807402|NCT05098054|143117022|OTHER||GLSM Ratio|145.42|||||TWO_SIDED|90.0|77.18|273.98|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||273.98|77.18|
71807403|NCT05098054|143117023|OTHER||GLSM Ratio|299.21|||||TWO_SIDED|90.0|111.75|801.17|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||801.17|111.75|
71807404|NCT05098054|143117023|OTHER||GLSM Ratio|130.25|||||TWO_SIDED|90.0|77.02|220.26|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||220.26|77.02|
71807405|NCT05098054|143117024|OTHER||GLSM Ratio|316.27|||||TWO_SIDED|90.0|117.68|849.97|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Moderate HI/Normal Hepatic Function (Matched to Moderate HI)"|||849.97|117.68|
71807406|NCT05098054|143117024|OTHER||GLSM Ratio|135.26|||||TWO_SIDED|90.0|91.22|200.57|||||"Geometric LSMs were calculated by exponentiating the LSMs from the mixed effects model.~Geometric LSM Ratio (GMR) = 100\*(Mild HI/Normal Hepatic Function (Matched to Mild HI)"|||200.57|91.22|
71807407|NCT01426191|143117026|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71807408|NCT01426191|143117027|OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
71807409|NCT02013622|143117028|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.||The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.||||<0.0001
71807410|NCT02013622|143117029|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
71807411|NCT02013622|143117030|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||<0.0001
71807412|NCT02013622|143117033|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0003
71807413|NCT02013622|143117034|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0002
71807414|NCT02013622|143117035|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16||||0.0177
71807415|NCT02013622|143117036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 effectiveness||||<0.0001
71807416|NCT02013622|143117036|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 side effects||||0.0031
71807417|NCT02013622|143117036|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 convenience||||0.0005
71807418|NCT02013622|143117036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 global satisfaction||||<0.0001
71807419|NCT02013622|143117037|SUPERIORITY_OR_OTHER|||||||0.5133|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)||||0.5133
71807420|NCT02013622|143117037|SUPERIORITY_OR_OTHER|||||||0.3774|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)||||0.3774
71807421|NCT02013622|143117038|SUPERIORITY_OR_OTHER|||||||0.8897|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)||||0.8897
71807422|NCT02013622|143117038|SUPERIORITY_OR_OTHER|||||||0.3401|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)||||0.3401
71807423|NCT02013622|143117039|SUPERIORITY_OR_OTHER|||||||0.4265|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DDT||||0.4265
71842752|NCT03279978|143197467|OTHER||Slope|0.5799|STANDARD_ERROR_OF_MEAN|0.0656|||TWO_SIDED|95.0|0.4441|0.7156||||||Dose proportionality for Cmax,ss of BI 730357 in plasma - fed groups was assessed using a power model (regression model applied to log-transformed data).|Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|0.7156|0.4441|
71842753|NCT00626795|143197477|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|4.56|||||TWO_SIDED|95.0|-1.59|10.71|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||10.71|-1.59|
71842754|NCT00626795|143197477|NON_INFERIORITY|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|-3.35|||||TWO_SIDED|95.0|-10.28|3.57|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).|||3.57|-10.28|
71842755|NCT04159519|143197484|OTHER|Mixed model for repeated measure (MMRM) with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.|Least square mean difference|0.1062|||||TWO_SIDED|95.0|-0.0485|0.2609||||||Comparison with reference arm||0.2609|-0.0485|
71842756|NCT04159519|143197485|OTHER|Comparison|Least square mean difference|-0.0343|||||TWO_SIDED|95.0|-0.2527|0.1841|||Mixed model for repeated measure (MMRM)|MMRM with fixed effects for treatment arm, visit, baseline value, and treatment-by-visit interaction with an unstructured covariance structure.||Comparison with reference arm||0.1841|-0.2527|
71842757|NCT02246127|143197511|SUPERIORITY||Odds Ratio (OR)|0.65||||0.229|TWO_SIDED|95.0|0.32|1.32|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.32|0.32|0.229
71842758|NCT02246127|143197512|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.135|TWO_SIDED|95.0|0.9|2.19|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.19|0.90|0.135
71842759|NCT02246127|143197513|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.474|TWO_SIDED|95.0|0.77|1.75|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||1.75|0.77|0.474
71842760|NCT02246127|143197515|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
71842761|NCT02246127|143197517|SUPERIORITY|||||||0.012|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.012
71842762|NCT02246127|143197518|SUPERIORITY|||||||0.001|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.001
71842763|NCT02246127|143197519|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.168|TWO_SIDED|95.0|0.86|2.37|||Regression, Cox|||significant differences between both arms is assumed in case p-val \< 0.05||2.37|0.86|0.168
71842764|NCT02246127|143197521|SUPERIORITY|||||||0.072|||||||Fisher Exact|||significant differences between both arms is assumed in case p-val \< 0.05||||0.072
71842765|NCT02246127|143197523|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.079|TWO_SIDED|95.0|0.94|2.73|||Log Rank|||significant differences between both arms is assumed in case p-val \< 0.05||2.73|0.94|0.079
71842766|NCT01223352|143197559|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.85|||||TWO_SIDED|95.0|0.61|1.2||No statistical test of hypothesis was set for this study. The analysis of PK data was carried out descriptively|||b.i.d. bosentan regimen was taken as reference|||1.20|0.61|
71842767|NCT01223352|143197560|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.71|||||TWO_SIDED|95.0|0.48|1.05||No statistical hypothesis tests were set for this study. The analysis of PK data was carried out descriptively.|||b.i.d. bosentan regimen was taken as reference|||1.05|0.48|
71842768|NCT03498521|143197567|SUPERIORITY||Stratified Cox proportional hazard|0.72||||0.0079|TWO_SIDED|95.0|0.56|0.92|||Stratified log-rank|||||0.92|0.56|0.0079
71842769|NCT04214834|143197613|SUPERIORITY||Mean Difference (Final Values)|2.96|||<|0.001|TWO_SIDED|95.0|1.7|4.29|||Mixed Models Analysis||Given that the model was on the log scale, mean difference and 95% confidence interval were derived from 1,000 bootstrap resamples.|A logarithmic transformation was applied to the outcome, centers were added as random effects to account for variation between them.||4.29|1.70|<0.001
71842770|NCT03370913|143197617|SUPERIORITY||% Reduction from Baseline|-77.0|||<|0.0001|TWO_SIDED|||||P-values were for 2-sided test against 0.|t-test, 2 sided|Superiority was tested by1-sample t-test to test null hypothesis that change is \>=0. Only negative changes represent efficacy.|77% reduction|Change from baseline in the ABR for all bleeds (post-baseline EEP value - baseline value)||||<0.0001
71894632|NCT05300087|143311035|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-t) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.022|||<|0.0001|TWO_SIDED|90.0|0.993|1.051|||ANOVA|||||1.051|0.993|<0.0001
71894633|NCT05300087|143311036|EQUIVALENCE|Bioequivalence would be demonstrated if the 90% confidence interval for the ratio of geometric means for AUC(0-inf) between the test and reference products were completely contained within the FDA defined acceptance range of 80.00%-125.00%.|Ratio of geometric least square mean|1.021|||<|0.0001|TWO_SIDED|90.0|0.994|1.048|||ANOVA|||||1.048|0.994|<0.0001
71676168|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.63||0.77|TWO_SIDED|95.0|0.16|3.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.80|0.16|0.77
71676169|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.18|STANDARD_ERROR_OF_MEAN|1.23||0.17|TWO_SIDED|95.0|0.72|6.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.61|0.72|0.17
71676170|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.46|STANDARD_ERROR_OF_MEAN|0.29||0.22|TWO_SIDED|95.0|0.14|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.57|0.14|0.22
71894634|NCT03248128|143311041|SUPERIORITY||Least Square Mean Difference|0.083|||<|0.001|TWO_SIDED|95.0|0.037|0.129|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.129|0.037|<0.001
71894635|NCT03248128|143311042|SUPERIORITY||Least Square Mean Difference|3.2||||0.228|TWO_SIDED|95.0|-2.0|8.4|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with covariates of baseline, region, sex, age and treatment.||||8.4|-2.0|0.228
71894636|NCT03248128|143311043|SUPERIORITY||Least Square Mean Difference|6.2||||0.011|TWO_SIDED|95.0|1.4|10.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||10.9|1.4|0.011
71894637|NCT03248128|143311044|SUPERIORITY||Least Square Mean Difference|0.073||||0.002|TWO_SIDED|95.0|0.028|0.118|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||0.118|0.028|0.002
71894638|NCT03248128|143311045|SUPERIORITY||Least Square Mean Difference|-0.3||||0.87|TWO_SIDED|95.0|-4.5|3.8|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||3.8|-4.5|0.870
71894639|NCT03248128|143311046|SUPERIORITY||Least Square Mean Difference|0.0||||0.988|TWO_SIDED|95.0|-4.2|4.1|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||4.1|-4.2|0.988
71894640|NCT03248128|143311047|SUPERIORITY||Least Square Mean Difference|0.035||||0.124|TWO_SIDED|0.95|-0.01|0.08|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.080|-0.010|0.124
71894641|NCT03248128|143311048|SUPERIORITY||Least Square Mean Difference|-0.01||||0.91|TWO_SIDED|95.0|-0.1|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.10|0.910
71894642|NCT03248128|143311049|SUPERIORITY||Least Square Mean Difference|1.3||||0.614|TWO_SIDED|95.0|-3.6|6.2|||ANCOVA|Analysis performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.2|-3.6|0.614
71676171|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.45|STANDARD_ERROR_OF_MEAN|1.94||0.02|TWO_SIDED|95.0|1.15|10.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||10.37|1.15|0.02
71807424|NCT02013622|143117040|SUPERIORITY_OR_OTHER|||||||0.2923|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value||||0.2923
71807425|NCT02013622|143117040|SUPERIORITY_OR_OTHER|||||||0.9416|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value||||0.9416
71807426|NCT02013622|143117041|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in DRT||||0.1815
71807427|NCT02013622|143117042|SUPERIORITY_OR_OTHER|||||||0.6648|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for food||||0.6648
71807428|NCT02013622|143117042|SUPERIORITY_OR_OTHER|||||||0.9812|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for money||||0.9812
71807429|NCT02013622|143117044|SUPERIORITY_OR_OTHER|||||||0.0306|TWO_SIDED||||||t-test, 2 sided|||Statistical analysis at Week 16||||0.0306
71807430|NCT04307004|143117055|SUPERIORITY|The threshold for statistical significance was p = 0.05|Mean Difference (Final Values)|0.8|||<|0.0001|TWO_SIDED|95.0|0.5|1.1|||Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure when attended - mean systolic blood pressure when not attended (i.e., unattended).|||1.1|0.5|< 0.0001
71807431|NCT04307004|143117055|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.0001|TWO_SIDED|95.0|0.3|0.7||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure when attended - mean diastolic blood pressure when not attended (i.e., unattended)|||0.7|0.3|< 0.0001
71807432|NCT04307004|143117056|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.5||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in systolic blood pressure = mean systolic blood pressure on ambulatory blood pressure monitoring - mean systolic blood pressure on home blood pressure monitoring.|||-1.5|-3.0|< 0.0001
71807433|NCT04307004|143117056|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.4||The threshold for statistical significance was p = 0.05|Paired T Test, 2-sided||Mean difference in diastolic blood pressure = mean diastolic blood pressure on ambulatory blood pressure monitoring - mean diastolic blood pressure on home blood pressure monitoring.|||-1.4|-2.5|< 0.0001
71807434|NCT04307004|143117058|OTHER|Independent variable - Attended systolic blood pressure. Dependent variable - Left ventricular mass index.|beta coefficient|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Linear|||We determined the association between attended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.32|< 0.001
71807435|NCT04307004|143117058|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.24|0.6|||Regression, Linear|||We determined the association between attended diastolic blood pressure measurements and left ventricular mass index (LVMI). This analysis included 587 with attended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.60|0.24|< 0.001
71807436|NCT04307004|143117058|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.33|0.56|||Regression, Linear|||We determined the association between unattended systolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.56|0.33|< 0.001
71807437|NCT04307004|143117058|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - left ventricular mass index.|beta coefficient|0.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.19|0.55|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and left ventricular mass index (LVMI). This analysis included 587 participants with unattended office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.19|< 0.001
71807438|NCT04307004|143117058|OTHER|Independent variable - awake systolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.47|0.74|||Regression, Linear|||We determined the association between awake systolic blood pressure from ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.74|0.47|< 0.001
71807439|NCT04307004|143117058|OTHER|Independent variable - awake diastolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.25|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 554 participants with out-of-office blood pressure measurements and valid LVMI measurements. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|0.25|< 0.001
71894643|NCT03248128|143311050|SUPERIORITY||Least Square Mean Difference|1.3||||0.594|TWO_SIDED|95.0|-3.6|6.3|||ANCOVA|Analysis was performed using ANCOVA with covariates of baseline, region, sex, age and treatment.||||6.3|-3.6|0.594
71677335|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.551|||||TWO_SIDED|95.0|0.367|0.826||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.826|0.367|
71807440|NCT04307004|143117058|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - left ventricular mass index.|beta coefficient|0.31|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|0.19|0.44|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with HBPM data and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.44|0.19|< 0.001
71807441|NCT04307004|143117058|OTHER|Independent variable - asleep diastolic blood pressure on HBPM Dependent variable - left ventricular mass index|beta coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED|95.0|0.05|0.4|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on HBPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|0.05|0.01
71807442|NCT04307004|143117058|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - left ventricular mass index.|beta coefficient|0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|0.32|0.59|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.59|0.32|< 0.001
71807443|NCT04307004|143117058|OTHER|Independent variable - asleep diastolic blood pressure on ABPM Dependent variable - left ventricular mass index.|beta coefficient|0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.16|0.55|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and left ventricular mass index (LVMI). This analysis included 533 participants with data on ABPM and valid LVMI. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.55|0.16|< 0.001
71807444|NCT04307004|143117059|OTHER|Independent variable - attended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.17|TWO_SIDED|95.0|-0.47|0.08|||Regression, Linear|||We determined the association between attended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.08|-0.47|0.17
71807445|NCT04307004|143117059|OTHER|Independent variable - attended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED|95.0|-0.7|0.15|||Regression, Linear|||We determined the association between attended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on attended office blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.15|-0.70|0.20
71807446|NCT04307004|143117059|OTHER|Independent variable - unattended systolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.14||0.07|TWO_SIDED|95.0|-0.55|0.02|||Regression, Linear|||We determined the association between unattended systolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.02|-0.55|0.07
71807447|NCT04307004|143117059|OTHER|Independent variable - unattended diastolic blood pressure. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.37|STANDARD_ERROR_OF_MEAN|0.22||0.09|TWO_SIDED|95.0|-0.8|0.06|||Regression, Linear|||We determined the association between unattended diastolic blood pressure and urinary albumin-to-creatinine ratio (UACR). This analysis included 555 participants with complete data on unattended diastolic blood pressure and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.06|-0.80|0.09
71807448|NCT04307004|143117059|OTHER|"Independent variable - awake systolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.01|STANDARD_ERROR_OF_MEAN|0.15||0.94|TWO_SIDED|95.0|-0.29|0.31|||Regression, Linear|||We determined the association between awake systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.31|-0.29|0.94
71813601|NCT05056870|143129519|SUPERIORITY|Superiority was declared if the upper limit of the 95% confidence interval of was below 0.00 logMAR.|Mean Difference|-0.097|STANDARD_ERROR_OF_MEAN|0.008|||TWO_SIDED|95.0|-0.113|-0.081|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.081|-0.113|
71813602|NCT05056870|143129520|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 0.|Mean Difference|28.0|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|22.6|33.3|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||33.3|22.6|
71813603|NCT05056870|143129521|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of was below 0.05 logMAR.|Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|-0.032|-0.008|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Mean difference was calculated as Test - Control|||-0.008|-0.032|
71813604|NCT05056870|143129522|SUPERIORITY|Superiority was declared if the lower limit of the 95% confidence interval of was above 1.|Mean Ratio|2.98|||||TWO_SIDED|95.0|1.73|5.11|||Generalized Linear Mixed Model||Mean Ratio was calculated as Test over Control|||5.11|1.73|
71894644|NCT03248128|143311051|SUPERIORITY||Least Square Mean Difference|0.028||||0.226|TWO_SIDED|95.0|-0.017|0.073|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.073|-0.017|0.226
71677336|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.426|||||TWO_SIDED|95.0|0.95|2.14||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.140|0.950|
71894645|NCT03248128|143311052|SUPERIORITY||Least Square Mean Difference|-0.02||||0.663|TWO_SIDED|95.0|-0.13|0.09|||Repeated measures analysis|||Analysis was performed using a repeated measures analysis adjusted for baseline, region, sex, age, treatment, visit, visit by baseline interaction and visit by treatment group interaction.||0.09|-0.13|0.663
71676172|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.45|STANDARD_ERROR_OF_MEAN|4.4||0.04|TWO_SIDED|95.0|1.12|26.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||26.53|1.12|0.04
71807449|NCT04307004|143117059|OTHER|"Independent variable - awake diastolic blood pressure on ambulatory blood pressure monitoring.~Dependent variable - urinary albumin-to-creatinine ratio."|beta coefficient|0.22|STANDARD_ERROR_OF_MEAN|0.22||0.31|TWO_SIDED|95.0|-0.21|0.66|||Regression, Linear|||We determined the association between awake diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 523 participants with complete data on ABPM and UACR. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.66|-0.21|0.31
71807450|NCT04307004|143117059|OTHER|Independent variable - asleep systolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.01|STANDARD_ERROR_OF_MEAN|0.14||0.94|TWO_SIDED|95.0|-0.28|0.26|||Regression, Linear|||We determined the association between asleep systolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.26|-0.28|0.94
71807451|NCT04307004|143117059|OTHER|Independent variable - asleep diastolic blood pressure on HBPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.93|TWO_SIDED|95.0|-0.4|0.36|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on home blood pressure monitoring (HBPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete HBPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.36|-0.40|0.93
71807452|NCT04307004|143117059|OTHER|Independent variable - asleep systolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.54|TWO_SIDED|95.0|-0.21|0.4|||Regression, Linear|||We determined the association between asleep systolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.40|-0.21|0.54
71842771|NCT04602611|143197625|SUPERIORITY||Coefficient of negative binomial model|0.0547||||0.8|TWO_SIDED|95.0|-0.368|0.4773||The a priori threshold for statistical significance was 0.025.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.||0.4773|-0.3680|0.80
71842772|NCT04602611|143197626|SUPERIORITY|||||||0.88||||||The a priori threshold for statistical significance was 0.025.|Fisher Exact|No adjustments were made in this analysis.||The study was designed with co-primary objectives evaluating acute care utilization (ACU) and 6-month OS rate. Power/sample size were calculated based on the OS objective. The overall type I error rate was alpha=0.05; the co-primary objectives were powered at the 2-sided alpha=0.025 significance level. Three hundred evaluable subjects would have provided \>=93% power to detect a 20% reduction in ACU (assuming there were 6 ACUs per year in SOC arm). The study did not achieve targeted enrollment.|The proportions of evaluable subjects surviving at 6 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 52/87(60%) evaluable subjects were alive at 6 months and 35/87 (40%) were not. In the ONN + SOC arm, 58/95 (61%) evaluable subjects were alive at 6 months and 37/95 (39%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.88.|||0.88
71894646|NCT00002850|143311074|SUPERIORITY_OR_OTHER|||||||0.218|||||||Fisher Exact|Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.||"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.~Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level."||||0.218
71894647|NCT02625402|143311077|EQUIVALENCE|Knowledge scores within 10% points|Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|7.6|<|0.05|TWO_SIDED|95.0|-8.8|21.5|||t-test, 2 sided|||||21.5|-8.8|<0.05
71676173|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.53||0.56|TWO_SIDED|95.0|0.1|3.47||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.47|0.10|0.56
71676174|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.55|STANDARD_ERROR_OF_MEAN|0.44||0.46|TWO_SIDED|95.0|0.11|2.68||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.68|0.11|0.46
71842773|NCT04602611|143197627|SUPERIORITY|||||||0.74||||||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Fisher Exact|No adjustments were made in this analysis.|||The proportions of evaluable subjects surviving at 12 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 23/87(26%) evaluable subjects were alive at 12 months and 64/87(74%) were not. In the ONN + SOC arm, 28/95 (29%) evaluable subjects were alive at 6 months and 67/95 (71%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.74.|||0.74
71842774|NCT04602611|143197628|SUPERIORITY||Coefficient of negative binomial model|0.1574||||0.57|TWO_SIDED|95.0|-0.3905|0.7054||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.7054|-0.3905|0.57
71676175|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.58|STANDARD_ERROR_OF_MEAN|0.66||0.0002|TWO_SIDED|95.0|1.56|4.27||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||4.27|1.56|0.0002
71842775|NCT04602611|143197629|SUPERIORITY||Hazard Ratio (HR)|0.864||||0.45|TWO_SIDED|95.0|0.57|1.309||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Log Rank|Unadjusted log-rank test|The estimated hazard ratio was associated with Oncology Nurse Navigation with reference to Standard of Care; the model was estimated without adjustments (the sole covariate was treatment).|||1.309|0.570|0.45
71842776|NCT04602611|143197630|SUPERIORITY||Coefficient of negative binomial model|-0.4194||||0.21|TWO_SIDED|95.0|-1.0763|0.2374||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Negative binomial|Model was estimated without adjustments (sole covariate was treatment; coefficient was the estimated treatment effect) using 180 degrees of freedom.|The estimated coefficient was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.2374|-1.0763|0.21
71842777|NCT04602611|143197631|SUPERIORITY||Odds Ratio (OR)|3.28|||<|0.01|TWO_SIDED|95.0|1.75|6.15||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Logistic|Model was estimated without adjustments (the sole covariate was treatment).|The estimated odds ratio was associated with Oncology Nurse Navigation with reference to Standard of Care.|||6.15|1.75|<0.01
71842778|NCT04602611|143197632|SUPERIORITY||Slope|-2.6939||||0.11|TWO_SIDED|95.0|-5.9538|0.5659||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|Model was estimated without adjustments (sole covariate was treatment; slope was the estimated treatment effect) using 180 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.5659|-5.9538|0.11
71842779|NCT04602611|143197633|SUPERIORITY||Slope|0.1197||||0.09|TWO_SIDED|95.0|-0.0315|0.4378||This p-value was not adjusted for multiple comparisons; the a priori threshold for statistical significance was p=0.05.|Regression, Linear|This univariate model was not adjusted for other covariates; this model was estimated using 84 degrees of freedom.|The estimated slope was associated with Oncology Nurse Navigation with reference to Standard of Care.|||0.4378|-0.0315|0.09
71842780|NCT04631016|143197634|OTHER||LS Mean Difference|0.024||||0.216|TWO_SIDED|80.0|-0.015|0.063|||Mixed Models Analysis|||||0.063|-0.015|0.216
71842781|NCT04631016|143197637|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.186|TWO_SIDED|80.0|0.57|1.11|||Regression, Cox|||||1.11|0.57|0.186
71842782|NCT04631016|143197658|SUPERIORITY||Least square mean difference|0.067||||0.044|TWO_SIDED|80.0|0.017|0.116||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the mixed model for repeated measures (MMRM) analysis at Week 12.||0.116|0.017|0.044
71842783|NCT04631016|143197658|SUPERIORITY||Least square mean difference|0.07||||0.036|TWO_SIDED|80.0|0.02|0.12||One-sided p-value|Mixed Models Analysis|Kenward-Roger correction has been used for degrees of freedom approximation in the generation of model.||Results are based on the MMRM analysis at Week 28.||0.120|0.020|0.036
71842784|NCT04496752|143197664|EQUIVALENCE|Weighted Cohen's kappa statistics were computed between DCTClock-pen and MMSE, and between DCTClock-tablet and MMSE. A TOST (two one-sided test) of equivalence was planned, with a difference in kappa of 0.2 specified a priori as significant.|Difference in Cohen's Kappa|0.07|||||TWO_SIDED|90.0|-0.05|0.19|||||The difference is Cohen's kappa is (tablet - pen). The confidence interval is estimated with a nonparametric bootstrap (5000 samples).|||0.19|-0.05|
71842785|NCT04967599|143197694|SUPERIORITY|||||||0.81|||||||Kruskal-Wallis|||||||.81
71842786|NCT04967599|143197695|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||||||.46
71842787|NCT04967599|143197696|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
71842788|NCT04967599|143197697|SUPERIORITY|||||||0.59|||||||Kruskal-Wallis|||||||.59
71842789|NCT04967599|143197698|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||.29
71842790|NCT04967599|143197699|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||.49
71842791|NCT04024059|143197722|SUPERIORITY||Odds Ratio (OR)|1.737|||=|0.22|TWO_SIDED|95.0|0.719|4.195|||Regression, Logistic|||||4.195|0.719|=0.22
71842792|NCT04024059|143197722|SUPERIORITY||Odds Ratio (OR)|1.035|||=|0.938|TWO_SIDED|95.0|0.435|2.461|||Regression, Logistic|||||2.461|0.435|=0.938
71676176|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.89|STANDARD_ERROR_OF_MEAN|0.48||0.0135|TWO_SIDED|95.0|1.14|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||3.12|1.14|0.0135
71842793|NCT04024059|143197723|SUPERIORITY||Odds Ratio (OR)|1.783|||=|0.202|TWO_SIDED|95.0|0.733|4.336|||Regression, Logistic|||||4.336|0.733|=0.202
71842794|NCT04024059|143197723|SUPERIORITY||Odds Ratio (OR)|1.38|||=|0.474|TWO_SIDED|95.0|0.571|3.336|||Regression, Logistic|||||3.336|0.571|=.474
71842795|NCT04024059|143197724|SUPERIORITY||Odds Ratio (OR)|0.669|||=|0.328|TWO_SIDED|95.0|0.299|1.497|||Regression, Logistic|||||1.497|0.299|=0.328
71842796|NCT04024059|143197724|SUPERIORITY||Odds Ratio (OR)|0.724|||=|0.435|TWO_SIDED|95.0|0.322|1.627|||Regression, Logistic|||||1.627|0.322|=0.435
71842797|NCT05541484|143197731|OTHER|Spearman's ρ given non-normal variable distributions|||||<|0.0001||||||Spearman's ρ given non-normal variable distributions|Wilcoxon (Mann-Whitney)|||||||< 0.0001
71842798|NCT02911805|143197737|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71842799|NCT03904576|143197746|OTHER||Difference of least squares means (T-R)|-7.305|STANDARD_ERROR_OF_MEAN|2.082|||TWO_SIDED|90.0|-10.949|-3.661||||||Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||-3.661|-10.949|
71842800|NCT03904576|143197746|OTHER||Difference in %|-24.396|||||||||||||Difference of least squares means in % (ratio to Placebo) (T-R)/R\*100%|Mixed effects model including effects for 'treatment', 'period' and 'subject' as well as covariates 'period baseline' and 'subject baseline'.||||
71842801|NCT03364127|143197764|SUPERIORITY||Mean Difference (Net)|-0.12||||0.702|TWO_SIDED|95.0|-0.76|0.51|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.51|-.76|0.702
71842802|NCT03364127|143197765|SUPERIORITY||Mean Difference (Net)|0.1||||0.77|TWO_SIDED|95.0|-0.58|0.79|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||.79|-.58|0.77
71842803|NCT03364127|143197766|SUPERIORITY||Mean Difference (Net)|1.16||||0.436|TWO_SIDED|95.0|-1.76|4.09|||ANCOVA|Full information maximum likelihood for missing data and to retain participants for intention to treat model. Adjusted for baseline value.||||4.09|-1.76|0.436
71842804|NCT03364127|143197767|SUPERIORITY||Hazard Ratio (HR)|2.72||||0.017|TWO_SIDED|95.0|1.13|6.54||Kaplan-Meier curves by treatment arm were examined to determine the rates of return to baseline over the 12-week follow-up period .|Log Rank|||Goal was to assess duration of effect among those who showed a response to the intervention (1.5 or greater decrease in PIN).||6.54|1.13|0.017
71842805|NCT02163694|143197768|SUPERIORITY|||||||0.003|||||||Log-rank test|||PFS was compared between the treatment groups using the log-rank test, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\] positive versus ER/PgR negative).||||0.003
71842806|NCT02163694|143197768|SUPERIORITY||Stratified Cox proportional hazards|0.728||||0.003|TWO_SIDED|95.0|0.59|0.9|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||0.900|0.590|0.003
71842807|NCT02163694|143197769|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.410
71676177|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.51|STANDARD_ERROR_OF_MEAN|0.56||0.2619|TWO_SIDED|95.0|0.73|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||3.12|0.73|0.2619
71807453|NCT04307004|143117059|OTHER|Independent variable - asleep diastolic blood pressure on ABPM. Dependent variable - urinary albumin-to-creatinine ratio.|beta coefficient|0.26|STANDARD_ERROR_OF_MEAN|0.21||0.23|TWO_SIDED|95.0|-0.16|0.68|||Regression, Linear|||We determined the association between asleep diastolic blood pressure on ambulatory blood pressure monitoring (ABPM) and urinary albumin-to-creatinine ratio (UACR). This analysis included 505 participants with complete ABPM and UACR data. This analysis combined across study arms as prespecified in the Study Protocol and Statistical Analysis Plan.||0.68|-0.16|0.23
71807454|NCT04009291|143117069|SUPERIORITY||||||=|0.2635|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.2635
71807455|NCT04009291|143117069|SUPERIORITY||||||=|0.6999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.6999
71807456|NCT04009291|143117069|SUPERIORITY||||||=|0.1394|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1394
71807457|NCT04009291|143117070|SUPERIORITY||||||=|0.1281|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.1281
71807458|NCT04009291|143117070|SUPERIORITY||||||>|0.9999|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||> 0.9999
71807459|NCT04009291|143117070|SUPERIORITY||||||=|0.0604|||||||t-test, 2 sided|||Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group||||= 0.0604
71807460|NCT01055769|143117103|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|97.81|||||TWO_SIDED|90.0|93.11|102.75||||||Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.75|93.11|
71807461|NCT01055769|143117104|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|113.67|||||TWO_SIDED|90.0|105.26|122.75||||||Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||122.75|105.26|
71807462|NCT01055769|143117105|NON_INFERIORITY_OR_EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric means ratio|97.65|||||TWO_SIDED|90.0|92.92|102.63||||||Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.63|92.92|
71807463|NCT02235493|143117108|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in MPOMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total MPOMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median MPOMA-G score used in the analyses.||||0.0625
71807464|NCT02235493|143117109|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in POMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total POMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median POMA-G score used in the analyses.||||0.1250
71842808|NCT02163694|143197769|SUPERIORITY||Stratified Cox proportional hazards|0.914||||0.41|TWO_SIDED|95.0|0.737|1.333|||Stratified Cox proportional hazards|||A Cox proportional hazards model, stratified by prior platinum therapy (Yes versus No) and receptor status (estrogen receptor (ER) and/or progesterone receptor (PgR) positive versus ER/PgR negative) was used to estimate the hazard ratio and 95% confidence interval comparing the two treatment arms.||1.333|0.737|0.410
71842809|NCT02163694|143197770|SUPERIORITY|||||||0.202||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.202
71842810|NCT02163694|143197771|SUPERIORITY|||||||0.715||||||Nominal P value is from Cochran-Mantel-Haenszel test stratified by ER/PgR status and prior platinum therapy use.|Cochran-Mantel-Haenszel|||||||0.715
71842811|NCT02163694|143197772|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
71676178|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.07|STANDARD_ERROR_OF_MEAN|0.76||0.0474|TWO_SIDED|95.0|1.01|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||4.24|1.01|0.0474
71676179|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.13|STANDARD_ERROR_OF_MEAN|0.58||0.8094|TWO_SIDED|95.0|0.42|3.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||3.07|0.42|0.8094
71676180|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.83|STANDARD_ERROR_OF_MEAN|0.6||0.7978|TWO_SIDED|95.0|0.2|3.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.44|0.20|0.7978
71807465|NCT02474927|143117135|OTHER|Descriptive (Pre-Post)||||||0.36|||||||Wilcoxon Signed Rank|||||||0.36
71807466|NCT02474927|143117136|OTHER|Descriptive (pre-post)||||||0.16|||||||Wilcoxon Signed Rank|||||||0.16
71807467|NCT01371851|143117146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0529||||0.05|TWO_SIDED||||||Regression, Logistic|||The analysis was applied to urine data obtained at all time points during weeks 1-8.||||0.05
71807468|NCT00833638|143117147|SUPERIORITY_OR_OTHER|||||||0.086||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.086
71807469|NCT00833638|143117147|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for day \<=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.006
71807470|NCT00833638|143117147|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for day \<=3. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.019
71807471|NCT00833638|143117147|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for day \<=2. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.022
71813605|NCT02487498|143129523|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) \> -20 mL|Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813||0.415|TWO_SIDED|95.0|-0.0342|-0.0023|||Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.||-0.0023|-0.0342|0.415
71813606|NCT02487498|143129524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0182|STANDARD_ERROR_OF_MEAN|0.00813|||TWO_SIDED|95.0|-0.0342|-0.0023||||||||-0.0023|-0.0342|
71813607|NCT02487498|143129525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0091|STANDARD_ERROR_OF_MEAN|0.01132|||TWO_SIDED|95.0|-0.0313|0.0131||||||||0.0131|-0.0313|
71894648|NCT01877655|143311085|SUPERIORITY||Odds Ratio (OR)|1.27||||0.205|TWO_SIDED|95.0|0.87|1.85||P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness \& donor CMV serostatus.|Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.||1.85|0.87|0.205
71813608|NCT02487498|143129526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0086|STANDARD_ERROR_OF_MEAN|0.00874|||TWO_SIDED|95.0|-0.0086|0.0258||||||||0.0258|-0.0086|
71813609|NCT00676130|143129532|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.7|||<|0.05||95.0|-9.3|15.0|||Chi-squared|||The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.||15|-9.3|<0.05
71813610|NCT00676130|143129533|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||<|0.05|TWO_SIDED|95.0|-6.5|6.3|||Chi-squared|||We assessed the rate of progression to abscess in the two groups.||6.3|-6.5|<0.05
71813611|NCT00755222|143129568|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
71813612|NCT00755222|143129569|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||ANOVA|||||||0.046
71813613|NCT00755222|143129570|SUPERIORITY_OR_OTHER|||||||0.164|||||||ANOVA|||||||0.164
71813614|NCT00755222|143129571|SUPERIORITY_OR_OTHER|||||||0.442|||||||ANOVA|||||||0.442
71813615|NCT00755222|143129572|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA|||||||0.095
71813616|NCT04382924|143129585|SUPERIORITY||Odds Ratio, log|0.0001|||<|0.025|TWO_SIDED||||||Chi-squared|||||||<0.025
71813617|NCT03243422|143129608|SUPERIORITY||change in Standard Deviation|0.002||||0.96|TWO_SIDED|95.0|-0.077|0.081|||Mixed Models Analysis|Three-level linear mixed effects model with an unstructured covariance matrix from the baseline and the year 3 in-person neurocognitive assessment||||0.081|-0.077|0.96
71813618|NCT03243422|143129609|SUPERIORITY||Slope|0.079||||0.15|TWO_SIDED|95.0|-0.029|0.187||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.187|-0.029|0.15
71813619|NCT03243422|143129610|SUPERIORITY||Slope|-0.02||||0.69|TWO_SIDED|95.0|-0.118|0.078||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.078|-0.118|0.69
71813620|NCT03243422|143129611|SUPERIORITY||Slope|0.017||||0.7|TWO_SIDED|95.0|-0.07|0.104||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Mixed Models Analysis|||||0.104|-0.070|0.70
71813621|NCT03243422|143129612|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.59|TWO_SIDED|95.0|0.61|1.33||Secondary outcomes were evaluated with Hochberg modification to the Bonferroni adjustment estimates are considered statistically significant if the largest p-value is \<0·05.|Regression, Cox|Discrete-time interval model||||1.33|0.61|0.59
71813622|NCT03243422|143129613|SUPERIORITY||Slope|0.191||||0.027|TWO_SIDED|95.0|0.022|0.36|||Mixed Models Analysis|||Analysis was restricted to ARIC participants who were enrolled in ACHIEVE||0.360|0.022|0.027
71813623|NCT03243422|143129614|SUPERIORITY||Slope|-0.061||||0.18|TWO_SIDED|95.0|-0.151|0.028|||Mixed Models Analysis|||||0.028|-0.151|0.18
71813624|NCT02466646|143129628|OTHER||Mean Difference (Net)|0.3|||<|0.01|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||<0.01
71813625|NCT02466646|143129629|OTHER||Mean Difference (Net)|2.0|||>|0.05|TWO_SIDED|||||The threshold for statistical significance was P=0.05|Kruskal-Wallis|||||||>0.05
71813626|NCT02466646|143129630|OTHER|||||||0.229||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.229
71813627|NCT02466646|143129631|OTHER|||||||0.28||||||Threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.280
71813628|NCT02466646|143129632|OTHER|||||||0.712|||||||Kruskal-Wallis|Threshold for statistical significance is p=0.05.||||||0.712
71813629|NCT02466646|143129633|OTHER|||||||0.674||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.674
71813630|NCT02466646|143129634|OTHER||Mean Difference (Net)|30.0||||0.006|TWO_SIDED|||||The threshold for statistical significance was p=0.05|Kruskal-Wallis|||||||0.006
71813631|NCT02466646|143129635|OTHER||Mean Difference (Net)|0.5||||0.373|TWO_SIDED||||||Kruskal-Wallis|||||||0.373
71813632|NCT02466646|143129636|OTHER||Mean Difference (Net)|0.6||||0.528|TWO_SIDED||||||Kruskal-Wallis|||||||0.528
71813633|NCT02466646|143129637|OTHER||Mean Difference (Net)|1.0||||0.208|TWO_SIDED||||||Kruskal-Wallis|||||||0.208
71813634|NCT02466646|143129638|OTHER|||||||0.051|||||||Kruskal-Wallis|||||||0.051
71813635|NCT02466646|143129639|OTHER|||||||0.647||||||The threshold for statistical significance is p=0.05.|Kruskal-Wallis|||||||0.647
71813636|NCT03261271|143129640|SUPERIORITY|||||||0.6489||||||P value less than 0.05 was considered statistically significant.|Mixed Models Analysis|||||||0.6489
71813637|NCT03261271|143129641|SUPERIORITY|||||||0.0323|||||||Mixed Models Analysis|||||||0.0323
71813638|NCT03261271|143129642|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71813639|NCT03261271|143129643|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71813640|NCT03261271|143129644|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||Difference between groups from Baseline to Study End.||||0.09
71813641|NCT03261271|143129644|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Difference between groups from baseline to pre-surgery.||||0.04
71813642|NCT02173054|143129645|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to compare number of participants who had erythema among 3 groups.|Kruskal-Wallis|||||||0.001
71813643|NCT02173054|143129645|SUPERIORITY_OR_OTHER|||||||0.016||||||This statistical analysis was used to compare number of participants who had dryness among 3 groups|Kruskal-Wallis|||||||0.016
71676181|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.29|STANDARD_ERROR_OF_MEAN|1.15||0.1016|TWO_SIDED|95.0|0.85|6.15||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||6.15|0.85|0.1016
71676182|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.25||0.157|TWO_SIDED|95.0|0.15|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.36|0.15|0.1570
71676183|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|3.02|STANDARD_ERROR_OF_MEAN|1.53||0.0297|TWO_SIDED|95.0|1.11|8.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||8.18|1.11|0.0297
71677337|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.295|||||TWO_SIDED|95.0|2.196|4.944||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.944|2.196|
71842812|NCT02163694|143197772|SUPERIORITY||Stratified Cox proportional hazards|0.737||||0.004|TWO_SIDED|95.0|0.597|0.908|||Stratified Cox proportional hazards|Stratified by prior platinum therapy (yes vs no) and receptor status (ER and/or PgR positive vs ER/PgR negative).||||0.908|0.597|0.004
71842813|NCT03662022|143197789|SUPERIORITY||incidence rate ratio|0.95|||<|0.017|TWO_SIDED|98.3|0.4|2.23||The significance level was determined at 0.017, to account for the fact that we made three comparisons, thus conclusions can be drawn by examining if the 98.3% CI for the incidence rate ratio (IRR) contains the critical value of 1.|Mixed Models Analysis|||||2.23|0.40|<0.017
71842814|NCT03662022|143197789|SUPERIORITY||incidence rate ratio|0.8||||0.017|TWO_SIDED|98.3|0.34|1.87|||Mixed Models Analysis|||||1.87|0.34|0.017
71842815|NCT03662022|143197789|SUPERIORITY||incidence rate ratio|0.58|||<|0.017|TWO_SIDED|98.3|0.22|1.56|||Mixed Models Analysis|||||1.56|0.22|<0.017
71842816|NCT04490109|143197792|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0148|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0148
71842817|NCT04490109|143197792|SUPERIORITY|The ANCOVA model for primary endpoint change from Baseline to Week 4 in average WI-NRS will have treatment group and Baseline weekly average WI-NRS as explanatory variables. Hypothesis will be tested using a Dunnett Testing Method, applying pairwise comparisons of each group to vehicle using a one-sided familywise error rate of 0.10. Treatment effect will be estimated as least squares means using vehicle as reference and adjusted using Dunnett Testing Method and presented with one-sided 90% CI.||||||0.0143|||||||ANCOVA|||Approximately 576 subjects may be enrolled to account for 16.7% drop out rate prior to completing the study. A total of 160 evaluable subjects per group are required to achieve at least 80% power to detect a difference of 0.65 in mean WI-NRS change from Baseline to Week 4 between one of two active doses of B244 and vehicle control when assuming a standard deviation of 2.5 and applying a Dunnett Testing Method at a one-sided familywise error rate of 0.10.||||0.0143
71842818|NCT04490109|143197794|SUPERIORITY|||||||0.0205|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0205
71842819|NCT04490109|143197795|SUPERIORITY|||||||0.0044|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0044
71842820|NCT04490109|143197795|SUPERIORITY|||||||0.0077|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0077
71842821|NCT04490109|143197796|SUPERIORITY|||||||0.04|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0400
71842822|NCT04490109|143197796|SUPERIORITY|||||||0.0486|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0486
71842823|NCT04490109|143197798|SUPERIORITY|||||||0.0246|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0246
71842824|NCT04490109|143197798|SUPERIORITY|||||||0.0366|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0366
71842825|NCT04490109|143197799|SUPERIORITY|||||||0.0467|||||||Regression, Logistic|||The frequency and rate of WI-NRS and AI-NRS responders will be reported and compared between treatment groups using a logistic regression model. Generalized estimating equations to account for repeated measures and within-subject variability may also be applied.||||0.0467
71842826|NCT04490109|143197800|SUPERIORITY|||||||0.0293|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0293
71807472|NCT00833638|143117147|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value for day \<=1. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p\>.025.|Regression, Logistic|||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.||||0.573
71807473|NCT00833638|143117148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.03|||<|0.001|TWO_SIDED|95.0|5.72|18.34||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||18.34|5.72|<0.001
71807474|NCT00833638|143117148|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.001|TWO_SIDED|95.0|6.48|19.12||No adjustment for multiplicity.|ANCOVA|Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg."||19.12|6.48|<0.001
71842827|NCT04490109|143197801|SUPERIORITY|||||||0.0045|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0045
71842828|NCT04490109|143197801|SUPERIORITY|||||||0.0043|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0043
71842829|NCT04490109|143197802|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0026
71842830|NCT04490109|143197802|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0005
71842831|NCT04490109|143197803|SUPERIORITY|||||||0.0348|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0348
71842832|NCT04490109|143197803|SUPERIORITY|||||||0.0173|||||||Mixed Models Analysis|||The difference in treatment groups in change from Baseline values at post-baseline visits will be analyzed using a mixed model with repeated measures.||||0.0173
71842833|NCT04490109|143197804|SUPERIORITY|||||||0.0228|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0228
71842834|NCT04490109|143197804|SUPERIORITY|||||||0.0015|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0015
71842835|NCT04490109|143197805|SUPERIORITY|||||||0.0003|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0003
71842836|NCT04490109|143197806|SUPERIORITY|||||||0.0195|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0195
71842837|NCT04490109|143197807|SUPERIORITY|||||||0.0365|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0365
71894649|NCT01877655|143311086|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.748|TWO_SIDED|95.0|0.76|1.22||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV viremia through 1 year posttransplant. CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The 95% CI was based on cumulative incidence function CMV viremia rate at 1 year.||1.22|0.76|0.748
71894650|NCT01877655|143311087|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.888|TWO_SIDED|95.0|0.8|1.29||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of CMV-specific antiviral therapy (AVT) through 1 year. Time to first adjudicated CMV-specific therapy was defined as time to the start of AVT for CMV viremia. CMV-specific AVT was determined by the adjudication committee. Rate was based on cumulative incidence function estimate at 1 year.||1.29|0.80|0.888
71894651|NCT01877655|143311088|SUPERIORITY||Odds Ratio (OR)|1.05||||0.802|TWO_SIDED|95.0|0.73|1.51||P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.|Analysis of composite of CMV viremia and adjudicated CMV-AVT. The CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.||1.51|0.73|0.802
71894652|NCT01877655|143311089|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.8|1.28||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment \& randomization strata adjusted for death as a competing risk||Analysis of rate of adjudicated CMV AVT or CMV EOD. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD and were determined by the adjudication committee. Rate based on cumulative incidence function estimate at 1 year.||1.28|0.80|0.928
71894653|NCT01877655|143311090|SUPERIORITY||Odds Ratio (OR)|1.18||||0.393|TWO_SIDED|95.0|0.81|1.73||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Analysis of all-cause mortality at 1 year. Participants with unknown survival status at 1 year were considered dead for this analysis.||1.73|0.81|0.393
71676184|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|5.28|STANDARD_ERROR_OF_MEAN|3.81||0.0213|TWO_SIDED|95.0|1.28|21.73||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||21.73|1.28|0.0213
71807475|NCT00833638|143117149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|8.51|22.29||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.29|8.51|<0.001
71807476|NCT00833638|143117149|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.41|||<|0.001|TWO_SIDED|95.0|13.5|27.31||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg."||27.31|13.50|<0.001
71807477|NCT00833638|143117150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.27|||<|0.001|TWO_SIDED|95.0|6.83|21.71||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.71|6.83|<0.001
71807478|NCT00833638|143117150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.54|||<|0.001|TWO_SIDED|95.0|13.07|28.01||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg."||28.01|13.07|<0.001
71894654|NCT05635838|143311091|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.506||0.0215|TWO_SIDED|95.0|-2.21|-0.18|||ANCOVA|||||-0.18|-2.21|0.0215
71894655|NCT05635838|143311093|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.485||0.1671|TWO_SIDED|95.0|-1.65|0.29|||ANCOVA|||||0.29|-1.65|0.1671
71894656|NCT05635838|143311094|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.728||0.7982|TWO_SIDED|95.0|-1.27|1.64|||ANCOVA|||||1.64|-1.27|0.7982
71676185|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.96|STANDARD_ERROR_OF_MEAN|0.78||0.9648|TWO_SIDED|95.0|0.2|4.74||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||4.74|0.20|0.9648
71677338|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.538|||||TWO_SIDED|95.0|1.026|2.303||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.303|1.026|
71807479|NCT00833638|143117151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.24|||<|0.001|TWO_SIDED|95.0|6.42|22.06||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||22.06|6.42|<0.001
71807480|NCT00833638|143117151|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.81|||<|0.001|TWO_SIDED|95.0|13.94|29.67||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg."||29.67|13.94|<0.001
71807481|NCT00833638|143117152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.92|||<|0.001|TWO_SIDED|95.0|6.3|21.55||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg."||21.55|6.30|<0.001
71807482|NCT00833638|143117152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.07|||<|0.001|TWO_SIDED|95.0|11.4|26.75||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg."||26.75|11.40|<0.001
71807483|NCT00833638|143117153|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.301
71807484|NCT00833638|143117153|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.046
71807485|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807486|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807487|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807488|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807489|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71813644|NCT02173054|143129645|SUPERIORITY_OR_OTHER|||||||0.025||||||This statistical analysis was used to compare number of participants who had scaling among 3 groups.|Kruskal-Wallis|||||||0.025
71894657|NCT05635838|143311095|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|0.94|STANDARD_ERROR_OF_MEAN|0.73||0.2031|TWO_SIDED|95.0|-0.52|2.4|||ANCOVA|||||2.40|-0.52|0.2031
71676186|NCT04075682|142870118|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.72|STANDARD_ERROR_OF_MEAN|0.53||0.6512|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6512
71807490|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807491|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
71807492|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.001
71807493|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
71807494|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
71807495|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.002
71807496|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.009
71807497|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.038
71807498|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807499|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807500|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807501|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71842838|NCT04490109|143197808|SUPERIORITY|||||||0.0086|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0086
71813645|NCT02173054|143129645|SUPERIORITY_OR_OTHER|||||||0.571||||||This statistical analysis was used to compare number of participants who had stinging among 3 groups.|Kruskal-Wallis|||||||0.571
71813646|NCT02173054|143129645|SUPERIORITY_OR_OTHER|||||||0.449||||||This statistical analysis was used to compare number of participants who had pruritus among 3 groups.|Kruskal-Wallis|||||||0.449
71813647|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.059||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.059
71813648|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.697||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test|||||||0.697
71813649|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.028||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.028
71813650|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
71813651|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.755||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.755
71813652|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.003||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.003
71813653|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.205||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.205
71813654|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.576||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.576
71813655|NCT02173054|143129646|SUPERIORITY_OR_OTHER|||||||0.16||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test|||||||0.160
71813656|NCT02173054|143129647|SUPERIORITY_OR_OTHER|||||||0.078||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.078
71813657|NCT02173054|143129647|SUPERIORITY_OR_OTHER|||||||0.167||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.167
71813658|NCT02173054|143129647|SUPERIORITY_OR_OTHER|||||||0.134||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group|Paired t-test|||||||0.134
71813659|NCT02173054|143129647|SUPERIORITY_OR_OTHER|||||||0.978||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group|Paired t-test|||||||0.978
71813660|NCT02173054|143129647|SUPERIORITY_OR_OTHER|||||||0.273||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test|||||||0.273
71813661|NCT02173054|143129647|SUPERIORITY_OR_OTHER|||||||0.735||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.735
71813662|NCT02173054|143129648|SUPERIORITY_OR_OTHER|||||||0.0002||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.|Paired t-test|||||||0.0002
71813663|NCT02173054|143129648|SUPERIORITY_OR_OTHER|||||||0.007||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.|Paired t-test|||||||0.007
71813664|NCT02173054|143129648|SUPERIORITY_OR_OTHER|||||||0.123||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test|||||||0.123
71813665|NCT02173054|143129649|SUPERIORITY_OR_OTHER|||||||0.005||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.005
71813666|NCT02173054|143129649|SUPERIORITY_OR_OTHER|||||||0.606||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.606
71813667|NCT02173054|143129649|SUPERIORITY_OR_OTHER|||||||0.001||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test|||||||0.001
71813668|NCT01083654|143129650|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.262|TWO_SIDED|95.0|0.2|1.55|||Regression, Logistic|||||1.55|0.20|.262
71813669|NCT01559454|143129651|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|35.4167||||0.097|TWO_SIDED|95.0|-8.7519|79.5852|||t-test, 2 sided|||||79.5852|-8.7519|0.097
71813670|NCT01559454|143129652|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||1|TWO_SIDED|95.0|0.0713|1.8248|||Fisher Exact|||||1.8248|0.0713|1.00
71813671|NCT01559454|143129653|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.55075||||0.348|TWO_SIDED|95.0|-20.37051|51.34968|||t-test, 2 sided|||||51.34968|-20.37051|0.348
71813672|NCT01559454|143129654|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.5833||||0.088|TWO_SIDED|95.0|-7.9653|87.132|||t-test, 2 sided|||||87.1320|-7.9653|0.088
71813673|NCT01559454|143129655|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1499||||0.895|TWO_SIDED|95.0|-30.3965|27.0632|||t-test, 2 sided|||||27.0632|-30.3965|0.895
71813674|NCT01559454|143129656|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.6||||0.6999|TWO_SIDED|95.0|0.127|2.8352|||Fisher Exact|||||2.8352|0.127|0.6999
71842839|NCT04490109|143197808|SUPERIORITY|||||||0.0035|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0035
71842840|NCT04490109|143197809|SUPERIORITY|||||||0.0074|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0074
71842841|NCT04490109|143197809|SUPERIORITY|||||||0.0008|||||||Regression, Logistic|||Responder rates for IGA and EASI will be summarized using descriptive statistics and analyzed using a logistic regression model at each respective timepoints.||||0.0008
71842842|NCT05954546|143197856|OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.62|1.72|||||Hazard ratio (HR) was estimated using multivariable Cox proportional hazard models.|Statistical analysis data is presented for Encorafenib+Binimetinib (RWD) relative to Encorafenib+Binimetinib (CTD) (reference).||1.72|0.62|
71676187|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.55|STANDARD_ERROR_OF_MEAN|0.66||0.41|TWO_SIDED|95.0|-0.75|1.85||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.85|-0.75|0.41
71842843|NCT03533257|143197862|SUPERIORITY|||||||0.3654|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3654
71842844|NCT03533257|143197863|SUPERIORITY|||||||0.6698|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.6698
71842845|NCT03533257|143197864|SUPERIORITY|||||||0.3086|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3086
71842846|NCT03533257|143197865|SUPERIORITY|||||||0.5552|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.5552
71894658|NCT05635838|143311097|SUPERIORITY|Response Variable = Treatment + Baseline AN Count Category (≥3 to 4, ≥5 to 10) + Visit + Treatment\*Visit|least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.683||0.2387|TWO_SIDED|95.0|-2.2|0.56|||ANCOVA|||||0.56|-2.20|0.2387
71842847|NCT03533257|143197866|SUPERIORITY|||||||0.0361|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.0361
71842848|NCT03533257|143197867|SUPERIORITY|||||||0.3585|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.3585
71842849|NCT03533257|143197868|SUPERIORITY|||||||0.8996|||||||Mixed Models Analysis|The analysis assessed the difference in estimated change-from-baseline values at the 24-week model estimate using LS means estimates from the MMRM.||||||0.8996
71842850|NCT04780581|143197869|EQUIVALENCE|log-rank statistic test.|Odds Ratio (OR)|1.0||||0.984|TWO_SIDED|95.0|0.2|5.1|||Log Rank|||Null hypothesis of equal survival curves. Estimates of rate and risk ratios are shown with 95% confidence intervals. All the p-values are 2-sided and shown without adjustment for multiple testing, and p \< 0.05 was considered statistically significant. The analyses were performed using IBM SPSS Statistics for Windows, Version 26.0 (Armonk, NY, USA: IBM Corp.).||5.1|0.2|0.984
71842851|NCT04780581|143197869|EQUIVALENCE|Log-rank method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-8.8|9.1||||||||9.1|-8.8|
71842852|NCT04780581|143197870|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.833|TWO_SIDED|95.0|0.4|3.0|||Chi-squared|||||3.0|0.4|0.833
71842853|NCT04780581|143197870|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-14.2|11.5||||||||11.5|-14.2|
71842854|NCT04780581|143197871|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.5||||0.661|TWO_SIDED|95.0|0.2|9.3|||Chi-squared|||non-invasive mechanical ventilation||9.3|0.2|0.661
71842855|NCT04780581|143197871|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.5|||||TWO_SIDED|95.0|-10.2|6.9||||||non-invasive mechanical ventilation||6.9|-10.2|
71842856|NCT04780581|143197871|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.7||||0.549|TWO_SIDED|95.0|0.2|2.2|||Chi-squared|||high-flow oxygen requirements||2.2|0.2|0.549
71842857|NCT04780581|143197871|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-8.2|15.1||||||high-flow oxygen requirements||15.1|-8.2|
71842858|NCT04780581|143197871|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.1||||0.809|TWO_SIDED|95.0|0.4|3.3|||Chi-squared|||Invasive mechanical ventilation or intubation requirements analysis||3.3|0.4|0.809
71842859|NCT04780581|143197871|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-13.0|11.1||||||Invasive mechanical ventilation or intubation requirements analysis||11.1|-13.0|
71842860|NCT04780581|143197872|EQUIVALENCE|T-test|Risk Difference (RD)|-0.3||||0.908|TWO_SIDED|95.0|-5.0|5.0|||t-test, 1 sided|||||5|-5|0.908
71894659|NCT02128490|143311134|SUPERIORITY_OR_OTHER||Difference in Proportions|35.9|||<|0.001|TWO_SIDED|95.0|20.8|51.0|||Fisher Exact|||||51.0|20.8|<0.001
71894660|NCT02128490|143311134|SUPERIORITY_OR_OTHER||Difference in Proportions|44.7|||<|0.001|TWO_SIDED|95.0|28.9|60.5|||Fisher Exact|||||60.5|28.9|<0.001
71894661|NCT02128490|143311134|SUPERIORITY_OR_OTHER||Difference in Proportions|22.4||||0.034|TWO_SIDED|95.0|3.7|41.0|||Fisher Exact|||||41.0|3.7|0.034
71894662|NCT02128490|143311134|SUPERIORITY_OR_OTHER||Difference in Proportions|4.2||||0.817|TWO_SIDED|95.0|-18.2|26.6|||Fisher Exact|||||26.6|-18.2|0.817
71894663|NCT02128490|143311135|SUPERIORITY_OR_OTHER||Difference in Proportions|12.6||||0.224|TWO_SIDED|95.0|-3.9|29.0|||Fisher Exact|||||29.0|-3.9|0.224
71894664|NCT02128490|143311135|SUPERIORITY_OR_OTHER||Difference in Proportions|31.6||||0.004|TWO_SIDED|95.0|13.1|50.1|||Fisher Exact|||||50.1|13.1|0.004
71676188|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.67|STANDARD_ERROR_OF_MEAN|0.96||0.08|TWO_SIDED|95.0|-3.55|0.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.21|-3.55|0.08
71676189|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.95||0.55|TWO_SIDED|95.0|-2.42|1.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.29|-2.42|0.55
71676190|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|1.36||0.38|TWO_SIDED|95.0|-1.47|3.86||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||3.86|-1.47|0.38
71807502|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807503|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807504|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807505|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807506|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807507|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807508|NCT00833638|143117154|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for day \<=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807509|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for day \<=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.003
71842861|NCT04780581|143197873|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|0.8||||0.758|TWO_SIDED|95.0|0.3|2.5|||Chi-squared|||Secondary infections||2.5|0.3|0.758
71807510|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for day \<=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.008
71807511|NCT00833638|143117154|SUPERIORITY_OR_OTHER|||||||0.246||95.0||||P-value for day \<=1. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."||||0.246
71807512|NCT00833638|143117155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.05|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807513|NCT00833638|143117156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807514|NCT00833638|143117157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71807515|NCT00833638|143117158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.11|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."||||<0.001
71842862|NCT04780581|143197873|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-10.1|13.7||||||Secondary infections||13.7|-10.1|
71842863|NCT04780581|143197873|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|4.2||||0.007|TWO_SIDED|95.0|1.4|12.3|||Chi-squared|||Hyperglycaemia||12.3|1.4|0.007
71842864|NCT04780581|143197873|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-18.9|||||TWO_SIDED|95.0|-31.8|-5.6||||||Hyperglycaemia||-5.6|-31.8|
71842865|NCT04780581|143197873|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|-1.6||||0.319|TWO_SIDED|95.0|-8.5|4.4|||Chi-squared|||Psychotic states||4.4|-8.5|0.319
71842866|NCT04780581|143197874|EQUIVALENCE|Cochran-Mantel-Haenszel test|Odds Ratio (OR)|1.0||||0.962|TWO_SIDED|95.0|0.4|2.3|||Chi-squared|||||2.3|0.4|0.962
71842867|NCT04780581|143197874|EQUIVALENCE|Cochran-Mantel-Haenszel test|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-14.2|14.9||||||||14.9|-14.2|
71842868|NCT01651000|143197883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71842869|NCT01651000|143197884|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71842870|NCT01651000|143197885|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71842871|NCT02765412|143197887|OTHER|multilevel model|Odds Ratio (OR)|0.67||||0.081|TWO_SIDED|95.0|0.58|0.78||Two-sided test; the a priori threshold being 0.05|Regression, Logistic|Adjusts for age, gender, race, comorbidities, implementation group, travel distance, and VAMC indicator|OR corresponding to the interaction between implementation group and lung cancer risk, a ratio of odds ratios. The OR for screening based on lung cancer risk in the SI group versus the OR for screening based on lung cancer risk in the II group|||0.78|0.58|0.081
71842872|NCT02765412|143197888|OTHER||Median Difference (Net)|-0.15||||0.35|TWO_SIDED|95.0|-0.16|0.46||Two-sided test; the a priori threshold being 0.05|t-test, 2 sided||Satisfaction rating on a scale of 0 to 10; Difference is Arm 1 - Arm 2|Simple t-test comparing mean satisfaction ratings between arms||0.46|-0.16|0.35
71842873|NCT04244175|143197892|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.11|||=|0.986|TWO_SIDED|90.0|-10.38|10.61|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||10.61|-10.38|=0.986
71842874|NCT04244175|143197892|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|1.42|||=|0.823|TWO_SIDED|90.0|-9.04|11.87|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||11.87|-9.04|=0.823
71842875|NCT04244175|143197892|SUPERIORITY|RRatio was analyzed using an analysis of covariance (ANCOVA) model including treatment and the Baseline seizure frequency per week as a covariate.|LS Mean Difference|0.76|||=|0.888|TWO_SIDED|90.0|-8.23|9.76|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||9.76|-8.23|=0.888
71842876|NCT04244175|143197893|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|4.9|||||TWO_SIDED|90.0|-12.0|19.3||||||CVL-865 25 mg BID vs Placebo||19.3|-12.0|
71677339|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.018|||||TWO_SIDED|95.0|0.679|1.526||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.526|0.679|
71807516|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.1||||||95.0|-2.9|2.8||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||2.8|-2.9|
71807517|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|3.5||||||95.0|0.4|6.6||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.6|0.4|
71842877|NCT04244175|143197893|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|1.4|||||TWO_SIDED|90.0|-16.1|16.2||||||CVL-865 7.5 mg BID vs Placebo||16.2|-16.1|
71842878|NCT04244175|143197893|SUPERIORITY|The percent reduction relative to Placebo was calculated.|Percent reduction relative to Placebo|3.2|||||TWO_SIDED|90.0|-11.4|15.8||||||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||15.8|-11.4|
71842879|NCT04244175|143197894|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.27|||=|0.587|TWO_SIDED|90.0|0.616|2.618|||Regression, Logistic|||CVL-865 25 mg BID vs Placebo||2.618|0.616|=0.587
71842880|NCT04244175|143197894|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.303|||=|0.554|TWO_SIDED|90.0|0.624|2.723|||Regression, Logistic|||CVL-865 7.5 mg BID vs Placebo||2.723|0.624|=0.554
71842881|NCT04244175|143197894|SUPERIORITY|A logistic regression with treatment group and Baseline seizure frequency as covariates was used to calculate the Odds ratio, 90% confidence interval, and p-value.|Odds Ratio (OR)|1.286|||=|0.513|TWO_SIDED|90.0|0.684|2.42|||Regression, Logistic|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.420|0.684|=0.513
71842882|NCT04244175|143197895|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||>|0.999|||||||Fisher's exact test|||CVL-865 25 mg BID vs Placebo||||>0.999
71842883|NCT04244175|143197895|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.618|||||||Fisher's exact test|||CVL-865 7.5 mg BID vs Placebo||||=0.618
71807518|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.6|9.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||9.7|4.6|
71842884|NCT04244175|143197895|SUPERIORITY|The p-value is from Fisher's exact test for number of responders.|||||=|0.422|||||||Fisher's exact test|||CVL-865 7.5 mg BID / 25 mg BID vs Placebo||||=0.422
71894665|NCT02128490|143311135|SUPERIORITY_OR_OTHER||Difference in Proportions|-17.5||||0.139|TWO_SIDED|95.0|-38.1|3.2|||Fisher Exact|||||3.2|-38.1|0.139
71807519|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|3.6||||||95.0|0.4|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.4|
71807520|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|7.2||||||95.0|4.4|10.0||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||10.0|4.4|
71842885|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.021|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.1|-0.8|=0.021
71842886|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.342|TWO_SIDED|90.0|-0.5|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.5|=0.342
71842887|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.059|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.0|-0.6|=0.059
71894666|NCT02128490|143311135|SUPERIORITY_OR_OTHER||Difference in Proportions|4.3||||0.815|TWO_SIDED|95.0|-17.9|26.4|||Fisher Exact|||||26.4|-17.9|0.815
71894667|NCT02128490|143311136|SUPERIORITY_OR_OTHER||Difference in Proportions|53.8|||<|0.001|TWO_SIDED|95.0|38.2|69.5|||Fisher Exact|||||69.5|38.2|<0.001
71894668|NCT02128490|143311136|SUPERIORITY_OR_OTHER||Difference in Proportions|55.3|||<|0.001|TWO_SIDED|95.0|39.5|71.1|||Fisher Exact|||||71.1|39.5|<0.001
71894669|NCT02128490|143311136|SUPERIORITY_OR_OTHER||Difference in Proportions|21.4||||0.069|TWO_SIDED|95.0|-0.3|43.1|||Fisher Exact|||||43.1|-0.3|0.069
71894670|NCT02128490|143311136|SUPERIORITY_OR_OTHER||Difference in Proportions|-4.2||||0.817|TWO_SIDED|95.0|-26.6|18.2|||Fisher Exact|||||18.2|-26.6|0.817
71894671|NCT02243176|143311137|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6236|TWO_SIDED|95.0|-0.22|0.13||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.13|-0.22|0.6236
71894672|NCT02243176|143311138|NON_INFERIORITY_OR_EQUIVALENCE|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.7809|TWO_SIDED|95.0|-0.21|0.15||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA\< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA\< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."||0.15|-0.21|0.7809
71894673|NCT02243176|143311139|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.39|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||0.39|0.12|<0.0001
71807521|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|3.7||||||95.0|0.6|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.||6.7|0.6|
71807522|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|0.4||||||95.0|-2.1|2.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||2.9|-2.1|
71677340|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.635|||||TWO_SIDED|95.0|1.754|3.959||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.959|1.754|
71807523|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|-0.4||||||95.0|-2.7|1.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.||1.9|-2.7|
71807524|NCT01680328|143117161|SUPERIORITY_OR_OTHER||Least Squares Mean|9.0||||||95.0|6.7|11.3||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.||11.3|6.7|
71894674|NCT02243176|143311140|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.5044|TWO_SIDED|95.0|0.74|1.15|||Cochran-Mantel-Haenszel|stratefied by baseline disease severity (HbA1c\<8%, \>=8%)||||1.15|0.74|0.5044
71894675|NCT02243176|143311141|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.0518|TWO_SIDED|95.0|0.98|1.67|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c \< 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose|||1.67|0.98|0.0518
71894676|NCT02243176|143311142|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.18||0.8915|TWO_SIDED|95.0|-0.33|0.38|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||0.38|-0.33|0.8915
71894677|NCT02243176|143311143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.249||0.2248|TWO_SIDED|95.0|-0.186|0.791|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||0.791|-0.186|0.2248
71894678|NCT02243176|143311144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48|STANDARD_ERROR_OF_MEAN|8.407||0.3739|TWO_SIDED|95.0|-9.039|24.005|||ANCOVA||Mean difference=Saxagliptin - Acarbose|||24.005|-9.039|0.3739
71807525|NCT01680328|143117162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||||95.0|0.5|1.4|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.4|0.5|
71807526|NCT01680328|143117162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.2|3.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.5|1.2|
71842888|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.5|||=|0.04|TWO_SIDED|90.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.1|-0.9|=0.040
71842889|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.152|TWO_SIDED|90.0|-0.8|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.1|-0.8|=0.152
71842890|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.044|TWO_SIDED|90.0|-0.8|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.8|=0.044
71842891|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.199|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.199
71894679|NCT02243176|143311145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.26||0.0078|TWO_SIDED|95.0|0.18|1.19|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|||1.19|0.18|0.0078
71894680|NCT03518840|143311156|SUPERIORITY||Mean Difference (Final Values)|-1.9615|STANDARD_ERROR_OF_MEAN|0.3329|<|0.001|TWO_SIDED|95.0|-2.6299|-1.2932|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline ASLR score following four weeks of SIJ belt therapy.||-1.2932|-2.6299|<.001
71807527|NCT01680328|143117162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||||95.0|1.4|3.0||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||3.0|1.4|
71842892|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.171|TWO_SIDED|90.0|-0.7|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.1|-0.7|=0.171
71842893|NCT04244175|143197897|SUPERIORITY|The PGI-C score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.125|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.125
71842894|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.767|TWO_SIDED|90.0|-0.3|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||0.2|-0.3|=0.767
71807528|NCT01680328|143117162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.8|1.4|
71807529|NCT01680328|143117162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||||95.0|1.4|4.6||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||4.6|1.4|
71894681|NCT03518840|143311157|SUPERIORITY||Median Difference (Final Values)|-1.9474|STANDARD_ERROR_OF_MEAN|0.3353|<|0.001|TWO_SIDED|95.0|-2.619|-1.2757|||paired t-test, 2 sided|||The null hypothesis is that there is no change in the baseline NRS score following four weeks of SIJ belt therapy.||-1.2757|-2.6190|<.001
71807530|NCT01680328|143117162|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.7|1.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.5|0.7|
71807531|NCT01680328|143117163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||||95.0|0.7|1.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.8|0.7|
71807532|NCT01680328|143117163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||||95.0|0.6|1.2||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed - i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.||1.2|0.6|
71807533|NCT01680328|143117164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7||||||95.0|2.4|5.5|||Odds ratio (OR)|||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as 'no versus yes', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs - i.e. a worse condition.||5.5|2.4|
71807534|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
71807535|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.4||||||95.0|-0.8|1.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.6|-0.8|
71807536|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.4|
71807537|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
71807538|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.7|-0.8|
71807539|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5||||||95.0|-0.7|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.7|
71807540|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.9||||||95.0|-0.3|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.1|-0.3|
71807541|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.0||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.0|-0.4|
71807542|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.1||||||95.0|-0.1|2.3||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.3|-0.1|
71807543|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||||95.0|1.0|3.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||3.5|1.0|
71807544|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.4||||||95.0|0.2|2.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||2.6|0.2|
71807545|NCT01680328|143117165|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.||1.8|-0.6|
71807546|NCT01680328|143117166|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.3||||||95.0|-0.9|1.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||1.5|-0.9|
71807547|NCT01680328|143117166|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.8||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.1|-0.4|
71807548|NCT01680328|143117166|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.6||||||95.0|0.3|2.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.8|0.3|
71807549|NCT01680328|143117166|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.9||||||95.0|3.7|6.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||6.1|3.7|
71807550|NCT01680328|143117166|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.7||||||95.0|0.5|2.9||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.||2.9|0.5|
71807551|NCT02959996|143117186|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71807552|NCT02959996|143117187|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
71807553|NCT02959996|143117188|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71807554|NCT02962908|143117195|OTHER|Inequality test.||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||0.45
71807555|NCT02962908|143117195|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 and to 42.||||<0.001
71807556|NCT02962908|143117195|OTHER|inequality test||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||0.88
71807557|NCT02962908|143117195|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 42.||||<0.001
71807558|NCT02962908|143117195|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||0.21
71807559|NCT02962908|143117195|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 42.||||<0.001
71807560|NCT02962908|143117195|OTHER|inequality test||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.77
71807561|NCT02962908|143117195|OTHER|inequality test||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 42.||||0.004
71807562|NCT02962908|143117195|OTHER|inequality test||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.08
71807563|NCT02962908|143117195|OTHER|inequality test||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 42.||||0.38
71807564|NCT02962908|143117195|OTHER|inequality test||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.49
71807565|NCT02962908|143117195|OTHER|inequality test||||||0.156|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 42.||||0.156
71807566|NCT02962908|143117195|OTHER|inequality test||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL-2 from day 0 to day 42.||||0.125
71807567|NCT02962908|143117195|OTHER|inequality test||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71807568|NCT02962908|143117195|OTHER|inequality test||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.72
71807569|NCT02962908|143117195|OTHER|inequality test||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 42.||||0.34
71807570|NCT02962908|143117196|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.62
71807571|NCT02962908|143117196|OTHER|inequality test||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IFN-gamma from day 0 to day 180.||||0.030
71807572|NCT02962908|143117196|OTHER|inequality test||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.87
71807573|NCT02962908|143117196|OTHER|inequality test||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for TNF-alpha from day 0 to day 180.||||0.075
71807574|NCT02962908|143117196|OTHER|inequality test||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||0.076
71807575|NCT02962908|143117196|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for IL-2 from day 0 to day 180.||||<0.001
71807576|NCT02962908|143117196|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
71807577|NCT02962908|143117196|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD4+ T cells positive for CD107a from day 0 to day 180.||||0.91
71807578|NCT02962908|143117196|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
71807579|NCT02962908|143117196|OTHER|inequality test||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IFN-gamma from day 0 to day 180.||||0.55
71807580|NCT02962908|143117196|OTHER|inequality||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
71807581|NCT02962908|143117196|OTHER|inequality test||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for TNF-alpha from day 0 to day 180.||||0.91
71807582|NCT02962908|143117196|OTHER|inequality test||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.21
71807583|NCT02962908|143117196|OTHER|inequality test||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for IL2 from day 0 to day 180.||||0.48
71807584|NCT02962908|143117196|OTHER|inequality test||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.62
71807585|NCT02962908|143117196|OTHER|inequality||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Comparison of the difference in median fold increase in number of CD8+ T cells positive for CD107a from day 0 to day 180.||||0.23
71807586|NCT02962908|143117197|OTHER|inequality test||||||0.8|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
71807587|NCT02962908|143117197|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
71807588|NCT02962908|143117197|OTHER|inequality test||||||0.23|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.23
71807589|NCT02962908|143117197|OTHER|||||||0.056|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.056
71807590|NCT02962908|143117197|OTHER|inequality test||||||0.74|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.74
71807591|NCT02962908|143117197|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 42. Differences considered significant if p-value \<0.05.||||<0.001
71807592|NCT02962908|143117197|OTHER|inequality test||||||0.34|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.34
71807593|NCT02962908|143117197|OTHER|inequality test||||||0.01|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.010
71842895|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.2|||=|0.178|TWO_SIDED|90.0|0.0|0.5|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.5|0.0|=0.178
71807594|NCT02962908|143117197|OTHER|inequality test||||||0.096|||||||Chi-squared|||Comparison of CD4+ IFNgamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.096
71807595|NCT02962908|143117197|OTHER|inequality test||||||0.049|||||||Fisher Exact|||Comparison of CD4+ IFNgamma responders on day 180.Differences considered significant if p-value \<0.05.||||0.049
71807596|NCT02962908|143117197|OTHER|inequality test||||||0.91|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.91
71807597|NCT02962908|143117197|OTHER|||||||0.39|||||||Chi-squared|||Comparison of CD4+ TNF alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.39
71807598|NCT02962908|143117197|OTHER|inequality test||||||0.94|||||||Chi-squared|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.94
71807599|NCT02962908|143117197|OTHER|inequality test|||||<|0.001|||||||Fisher Exact|||Comparison of CD4+ IL-2 responders on day 180. Differences considered significant if p-value \<0.05.||||<0.001
71807600|NCT02962908|143117197|OTHER|inequality test||||||0.044|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.044
71807601|NCT02962908|143117197|OTHER|inequality test||||||0.98|||||||Fisher Exact|||Comparison of CD4+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.98
71807602|NCT02962908|143117197|OTHER|inequality test||||||0.48|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.48
71807603|NCT02962908|143117197|OTHER|inequality test||||||0.28|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 42. Differences considered significant if p-value \<0.05.||||0.28
71807604|NCT02962908|143117197|OTHER|inequality test||||||0.7|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.70
71807605|NCT02962908|143117197|OTHER|inequality test||||||0.175|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 42. Differences considered significant if p-value \<0.05.||||0.175
71807606|NCT02962908|143117197|OTHER|inequality test||||||0.24|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.24
71807607|NCT02962908|143117197|OTHER|inequality test||||||0.8|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 42. Differences considered significant if p-value \<0.05.||||0.80
71807608|NCT02962908|143117197|OTHER|inequality test||||||0.023|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.023
71807609|NCT02962908|143117197|OTHER|inequality test||||||0.015|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 42. Differences considered significant if p-value \<0.05.||||0.015
71894682|NCT05652660|143311158|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|120.5|||||TWO_SIDED|90.0|104.77|138.59|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed Cmax was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||138.59|104.77|
71807610|NCT02962908|143117197|OTHER|inequality test||||||0.81|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.81
71807611|NCT02962908|143117197|OTHER|inequality test||||||0.34|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IFN-gamma responders on day 180. Differences considered significant if p-value \<0.05.||||0.34
71807612|NCT02962908|143117197|OTHER|inequality test||||||0.3|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.30
71807613|NCT02962908|143117197|OTHER|inequality test||||||0.105|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ TNF-alpha responders on day 180. Differences considered significant if p-value \<0.05.||||0.105
71807614|NCT02962908|143117197|OTHER|inequality test||||||0.38|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.38
71807615|NCT02962908|143117197|OTHER|inequality test||||||0.44|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ IL2 responders on day 180. Differences considered significant if p-value \<0.05.||||0.44
71807616|NCT02962908|143117197|OTHER|inequality test||||||0.58|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.58
71807617|NCT02962908|143117197|OTHER|inequality test||||||0.43|||||||Chi squared or Fisher's exact test|||Comparison of CD8+ CD107a responders on day 180. Differences considered significant if p-value \<0.05.||||0.43
71807618|NCT02962908|143117198|OTHER|inequality test||||||0.25|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||0.25
71807619|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||1.0
71807620|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL-2 at day 42||||1.00
71807621|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||1.00
71807622|NCT02962908|143117198|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 42||||<0.001
71807623|NCT02962908|143117198|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 42||||<0.001
71807624|NCT02962908|143117198|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 42||||<0.001
71894683|NCT05652660|143311159|OTHER|Mixed Model|Ratio (%) of Adjusted Geometric Means|110.56|||||TWO_SIDED|90.0|103.53|118.06|||||The ratios (and 90% CIs) are expressed as percentages.|Rosuvastatin administered alone as the Reference and ARV-471 coadministered with rosuvastatin as the Test. Natural log transformed AUClast was analyzed using a mixed effect model with treatment as fixed effects and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||118.06|103.53|
71807625|NCT02962908|143117198|OTHER|inequality test||||||0.31|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 42||||0.31
71807626|NCT02962908|143117198|OTHER|inequality test||||||0.48|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||0.48
71807627|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||1.00
71807628|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||1.00
71807629|NCT02962908|143117198|OTHER|inequality test||||||0.59|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||0.59
71807630|NCT02962908|143117198|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IFN-gamma at day 180||||<0.001
71807631|NCT02962908|143117198|OTHER|inequality test||||||0.013|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing TNF-alpha at day 180||||0.013
71807632|NCT02962908|143117198|OTHER|inequality|||||<|0.001|||||||Chi-squared|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing IL2 at day 180||||<0.001
71807633|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD4+ T-cell producing CD107a at day 180||||1.00
71807634|NCT02962908|143117198|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
71807635|NCT02962908|143117198|OTHER|inequality test||||||0.55|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 42||||0.55
71807636|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 42||||1.00
71807637|NCT02962908|143117198|OTHER|inequality test||||||0.29|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||0.29
71807638|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
71807639|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing IFN-gamma at day 180||||1.00
71807640|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing TNF-alpha at day 180||||1.00
71807641|NCT02962908|143117198|OTHER|inequality test||||||1|||||||Fisher Exact|||Comparison of responders determined by MIMOSA analysis of CD8+ T-cell producing CD107a at day 180||||1.00
71807642|NCT02962908|143117199|OTHER|inequality test||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.59
71807643|NCT02962908|143117199|OTHER|inequality test||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 42. p\<0.05 considered statistically significant.||||0.001
71807644|NCT02962908|143117199|OTHER|inequality test||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||0.61
71807645|NCT02962908|143117199|OTHER|inequality test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of median fold-increase in IFN-gamma secretion as measured by ELISA on day 180. p\<0.05 considered statistically significant.||||<0.001
71807646|NCT02962908|143117200|OTHER|||||||0.113|||||||Wilcoxon (Mann-Whitney)|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||0.113
71807647|NCT02962908|143117200|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."||||<0.001
71842896|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.542|TWO_SIDED|90.0|-0.1|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||0.3|-0.1|=0.542
71894684|NCT03704051|143311169|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.634|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.634
71894685|NCT03704051|143311170|EQUIVALENCE|A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.||||||0.115|||||||Mixed Models Analysis|All models adjusted for order of conditions, time since last feeding and infant age.||||||0.115
71894686|NCT01943539|143311182|SUPERIORITY||Effect Size|0.62||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
71807648|NCT02962908|143117200|OTHER|||||||0.399|||||||Chi-squared|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||0.399
71894687|NCT03199911|143311186|SUPERIORITY||Risk Ratio (RR)|0.0||||0.025|TWO_SIDED||||||Fisher Exact|||||||0.025
71894688|NCT03199911|143311188|SUPERIORITY||Risk Ratio (RR)|1.3||||0.77|TWO_SIDED|95.0|0.42|4.03|||Fisher Exact|||||4.03|0.42|0.77
71807649|NCT02962908|143117200|OTHER||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."||||<0.001
71807650|NCT02962908|143117202|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42 post-vaccination.||||<0.001
71807651|NCT02962908|143117202|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42.||||<0.001
71807652|NCT02962908|143117202|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
71807653|NCT02962908|143117202|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.||||<0.001
71807654|NCT02962908|143117205|OTHER|||||||0.662|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.662
71807655|NCT02962908|143117205|OTHER|||||||0.168|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.||||0.168
71807656|NCT02962908|143117206|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||The study was not powered to detected statistical significant differences in this outcome.|||>0.05
71807657|NCT02962908|143117206|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||Study not powered to detect statistically significant differences|||>0.05
71807658|NCT02962908|143117207|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison in the duration of symptoms between treatment group and corresponding placebo.||||0.513
71807659|NCT02962908|143117207|OTHER|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of the duration of symptoms between treatment group and corresponding placebo.||||0.578
71894689|NCT03199911|143311189|SUPERIORITY||Risk Ratio (RR)|0.93||||1|TWO_SIDED|95.0|0.06|14.77|||Fisher Exact|||||14.77|0.06|1.00
71807660|NCT02962908|143117207|OTHER|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison of total symptom score between treatment group and corresponding placebo.||||0.513
71807661|NCT02962908|143117207|OTHER|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total symptom score between treatment group and corresponding placebo.||||0.200
71807662|NCT02962908|143117207|OTHER|||||||0.658|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.658
71807663|NCT02962908|143117207|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.||||0.640
71807664|NCT02962908|143117207|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.127
71807665|NCT02962908|143117207|OTHER|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.||||0.201
71807666|NCT02962908|143117208|OTHER|inequality test||||||0.85|||||||Chi-squared|||comparison between groups on day 42||||0.85
71842897|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.106|TWO_SIDED|90.0|-0.6|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||0.0|-0.6|=0.106
71807667|NCT02962908|143117208|OTHER|inequality test||||||0.042|||||||Fisher Exact|||comparison between groups on day 42||||0.042
71807668|NCT02962908|143117208|OTHER|inequality test||||||0.69|||||||Fisher Exact|||comparison between groups on day 180||||0.69
71807669|NCT02962908|143117208|OTHER|inequality test||||||0.198|||||||Fisher Exact|||comparison between groups on day 180||||0.198
71842898|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.1|||=|0.663|TWO_SIDED|90.0|-0.2|0.4|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.4|-0.2|=0.663
71842899|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.488|TWO_SIDED|90.0|-0.4|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||0.2|-0.4|=0.488
71842900|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.1|TWO_SIDED|90.0|-0.7|0.0|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||0.0|-0.7|=0.100
71807670|NCT02962908|143117208|OTHER|inequality test||||||0.092|||||||Chi-squared|||comparison between groups on day 42||||0.092
71807671|NCT02962908|143117208|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparison of groups on day 42||||<0.001
71807672|NCT02962908|143117208|OTHER|inequality test||||||0.27|||||||Chi-squared|||comparison of groups on day 180||||0.27
71807673|NCT02962908|143117208|OTHER|inequality test|||||<|0.001|||||||Chi-squared|||comparisons between groups on day 180||||<0.001
71807674|NCT05540522|143117222|OTHER||RVE|34.5|||||TWO_SIDED|95.0|7.4|53.9||||||||53.9|7.4|
71807675|NCT05540522|143117223|OTHER||RVE|-5.8|||||TWO_SIDED|95.0|-47.2|23.8||||||||23.8|-47.2|
71807676|NCT05540522|143117244|OTHER||GMR|1.23|||||TWO_SIDED|95.0|1.1|1.38||||||A/H3N2||1.38|1.10|
71807677|NCT05540522|143117244|OTHER||GMR|1.24|||||TWO_SIDED|95.0|1.1|1.39||||||A/H1N1||1.39|1.10|
71807678|NCT05540522|143117244|OTHER||GMR|0.73|||||TWO_SIDED|95.0|0.67|0.8||||||B/Yamagata||0.80|0.67|
71807679|NCT05540522|143117244|OTHER||GMR|0.3|||||TWO_SIDED|95.0|0.26|0.35||||||B/Victoria||0.35|0.26|
71807680|NCT05540522|143117245|OTHER||GMR|1.65|||||TWO_SIDED|95.0|1.47|1.84||||||A/H3N2||1.84|1.47|
71807681|NCT05540522|143117245|OTHER||GMR|1.71|||||TWO_SIDED|95.0|1.51|1.92||||||A/H1N1||1.92|1.51|
71807682|NCT05540522|143117245|OTHER||GMR|1.04|||||TWO_SIDED|95.0|0.95|1.14||||||B/Yamagata||1.14|0.95|
71807683|NCT05540522|143117245|OTHER||GMR|0.61|||||TWO_SIDED|95.0|0.54|0.69||||||B/Victoria||0.69|0.54|
71807684|NCT05540522|143117246|OTHER||Difference in percentage|11.4|||||TWO_SIDED|95.0|6.4|16.4||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||16.4|6.4|
71807685|NCT05540522|143117246|OTHER||Difference in percentage|13.6|||||TWO_SIDED|95.0|8.6|18.6||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||18.6|8.6|
71807686|NCT05540522|143117246|OTHER||Difference in percentage|-15.3|||||TWO_SIDED|95.0|-19.5|-11.2||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.2|-19.5|
71807687|NCT05540522|143117246|OTHER||Difference in percentage|-40.5|||||TWO_SIDED|95.0|-44.7|-36.1||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-36.1|-44.7|
71807688|NCT05540522|143117247|OTHER||Difference in percentage|21.6|||||TWO_SIDED|95.0|16.7|26.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||26.5|16.7|
71807689|NCT05540522|143117247|OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|20.9|30.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||30.4|20.9|
71807690|NCT05540522|143117247|OTHER||Difference in percentage|-2.1|||||TWO_SIDED|95.0|-4.8|0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||0.6|-4.8|
71807691|NCT05540522|143117247|OTHER||Difference in percentage|-22.6|||||TWO_SIDED|95.0|-26.7|-18.5||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-18.5|-26.7|
71807692|NCT05540522|143117248|OTHER||GMR|1.92|||||TWO_SIDED|95.0|1.78|2.07||||||A/H3N2||2.07|1.78|
71807693|NCT05540522|143117248|OTHER||GMR|1.68|||||TWO_SIDED|95.0|1.55|1.82||||||A/H1N1||1.82|1.55|
71894690|NCT00345605|143311197|SUPERIORITY_OR_OTHER||Slope|0.5|||||TWO_SIDED||||||||Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|For sample size calculation, we used the means and standard deviation for PT, PTT. Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.||||
71807694|NCT05540522|143117248|OTHER||GMR|0.88|||||TWO_SIDED|95.0|0.82|0.94||||||B/Yamagata||0.94|0.82|
71807695|NCT05540522|143117248|OTHER||GMR|0.58|||||TWO_SIDED|95.0|0.53|0.63||||||B/Victoria||0.63|0.53|
71807696|NCT05540522|143117249|OTHER||GMR|2.38|||||TWO_SIDED|95.0|2.23|2.54||||||A/H3N2||2.54|2.23|
71807697|NCT05540522|143117249|OTHER||GMR|2.37|||||TWO_SIDED|95.0|2.22|2.54||||||A/H1N1||2.54|2.22|
71807698|NCT05540522|143117249|OTHER||GMR|1.36|||||TWO_SIDED|95.0|1.29|1.43||||||B/Yamagata||1.43|1.29|
71807699|NCT05540522|143117249|OTHER||GMR|0.76|||||TWO_SIDED|95.0|0.71|0.81||||||B/Victoria||0.81|0.71|
71807700|NCT05540522|143117250|OTHER||Difference in Percentage|26.8|||||TWO_SIDED|95.0|23.7|29.9||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.9|23.7|
71807701|NCT05540522|143117250|OTHER||Difference in Percentage|26.9|||||TWO_SIDED|95.0|23.9|29.8||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||29.8|23.9|
71807702|NCT05540522|143117250|OTHER||Difference in Percentage|-3.6|||||TWO_SIDED|95.0|-6.6|-0.6||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-0.6|-6.6|
71807703|NCT05540522|143117250|OTHER||Difference in Percentage|-19.2|||||TWO_SIDED|95.0|-21.9|-16.6||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-16.6|-21.9|
71807704|NCT05540522|143117251|OTHER||Difference in Percentage|37.9|||||TWO_SIDED|95.0|35.2|40.5||||||A/H3N2: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||40.5|35.2|
71807705|NCT05540522|143117251|OTHER||Difference in Percentage|44.9|||||TWO_SIDED|95.0|42.4|47.4||||||A/H1N1: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||47.4|42.4|
71807706|NCT05540522|143117251|OTHER||Difference in Percentage|10.6|||||TWO_SIDED|95.0|8.5|12.8||||||B/Yamagata: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||12.8|8.5|
71807707|NCT05540522|143117251|OTHER||Difference in Percentage|-13.8|||||TWO_SIDED|95.0|-16.3|-11.3||||||B/Victoria: 2-Sided CI, difference in percents (qIRV - Licensed QIV), expressed as a percentage.||-11.3|-16.3|
71894691|NCT01335971|143311204|SUPERIORITY_OR_OTHER|||||||0.45|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages||||0.45
71807708|NCT00857207|143117320|SUPERIORITY||Mean Difference (Final Values)|-3.95|STANDARD_ERROR_OF_MEAN|1.14||0.0004|TWO_SIDED|95.0|||||Regression, Linear|dependent variable: post-treatment outcome; independent variables:pre-treatment measurement and group indicator.||Linear regression of change of cTOL time to first move in GMT versus BHW group||||0.0004
71807709|NCT00857207|143117320|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_DEVIATION|3.55||0.012|TWO_SIDED|95.0|||||t-test, 2 sided|||total time will significantly improve 10 weeks from post||||0.012
71807710|NCT00857207|143117320|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.04||0.98|TWO_SIDED|95.0|||||t-test, 2 sided|||Time to first move will significantly increase at 10 weeks from baseline to indicate better planning||||0.98
71807711|NCT00857207|143117321|SUPERIORITY||Mean Difference (Final Values)|2.64|STANDARD_DEVIATION|6.42||0.15|TWO_SIDED|95.0|||||t-test, 2 sided|||paired T-test, Behavioral Regulation Index will improve at week 10 from baseline||||0.15
71807712|NCT00857207|143117321|SUPERIORITY||Mean Difference (Final Values)|2.79|STANDARD_DEVIATION|8.4||0.24|TWO_SIDED|95.0|||||t-test, 2 sided|||paired t-test of Metacognitive Index, MI will improve at 10 weeks compared to baseline.||||0.24
71807713|NCT00857207|143117322|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|||||t-test, 2 sided|||optimal moves will significantly increase at 10 weeks from baseline||||0.30
71807714|NCT03035292|143117331|SUPERIORITY||||||<|0.05||||||This value of \<0.05 is the calculated p value where the a priori threshold for statistical significance is considered to be p=0.05.|McNemar|||Sample size was based on a cataract prevalence of 20% in the enriched population and a predicted difference of 15% sensitivity and specificity between tests.||||<0.05
71807715|NCT03035292|143117333|SUPERIORITY||||||<|0.05||||||The calculated p value was \<0.05. A priori threshold for statistical significance is p=0.05|Fisher Exact|||Evidence of superiority of intervention 2 over intervention 1 requires a significant difference in specificity of the intervention 1 and 2 between ethnicity groups.||||<0.05
71807716|NCT00440531|143117334|SUPERIORITY_OR_OTHER||single-group percentage|75.7||||||95.0|68.0|82.2||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||82.20|68|
71807717|NCT00440531|143117334|SUPERIORITY_OR_OTHER||single-group percentage|68.0||||||95.0|59.8|75.5||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.||75.50|59.80|
71807718|NCT00440531|143117335|SUPERIORITY_OR_OTHER||Single-Group Percentage|84.0||||||95.0|77.0|89.6||||||No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs \>=10mIU/mL) for ENGERIX-B™ at 1 month post vaccination 3, among subjects who were seronegative at baseline.||89.60|77|
71807719|NCT01786512|143117392|OTHER||Treatment difference|0.0112|STANDARD_ERROR_OF_MEAN|0.0033||0.0007|TWO_SIDED|95.0|0.0047|0.0176|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0176|0.0047|0.0007
71807720|NCT01786512|143117392|OTHER||Treatment difference|0.025|STANDARD_ERROR_OF_MEAN|0.0033|<|0.0001|TWO_SIDED|95.0|0.0184|0.0315|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.0315|0.0184|<0.0001
71894692|NCT01335971|143311204|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages||||0.40
71807721|NCT01786512|143117393|OTHER||Treatment difference|4.58|STANDARD_ERROR_OF_MEAN|1.56||0.0036|TWO_SIDED|95.0|1.5|7.65|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||7.65|1.50|0.0036
71807722|NCT01786512|143117393|OTHER||Treatment difference|3.63|STANDARD_ERROR_OF_MEAN|1.57||0.0217|TWO_SIDED|95.0|0.53|6.72|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||6.72|0.53|0.0217
71807723|NCT01786512|143117394|OTHER||Treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.058||0.1732|TWO_SIDED|95.0|-0.194|0.035|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.035|-0.194|0.1732
71807724|NCT01786512|143117394|OTHER||Treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.059||0.0027|TWO_SIDED|95.0|-0.295|-0.062|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.062|-0.295|0.0027
71807725|NCT01786512|143117395|OTHER||Treatment difference|-0.067|STANDARD_ERROR_OF_MEAN|0.051||0.1899|TWO_SIDED|95.0|-0.166|0.033|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.033|-0.166|0.1899
71807726|NCT01786512|143117395|OTHER||Treatment difference|-0.129|STANDARD_ERROR_OF_MEAN|0.052||0.0128|TWO_SIDED|95.0|-0.231|-0.028|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.028|-0.231|0.0128
71807727|NCT01786512|143117396|OTHER||Treatment difference|-1.34|STANDARD_ERROR_OF_MEAN|1.09||0.2177|TWO_SIDED|95.0|-3.47|0.79|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||0.79|-3.47|0.2177
71807728|NCT01786512|143117396|OTHER||Treatment difference|-2.97|STANDARD_ERROR_OF_MEAN|1.09||0.007|TWO_SIDED|95.0|-5.12|-0.81|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-0.81|-5.12|0.0070
71807729|NCT01786512|143117397|OTHER||Treatment difference|-822.0|STANDARD_ERROR_OF_MEAN|353.0||0.0205|TWO_SIDED|95.0|-1516.0|-127.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-127|-1516|0.0205
71807730|NCT01786512|143117397|OTHER||Treatment difference|-970.0|STANDARD_ERROR_OF_MEAN|357.0||0.0069|TWO_SIDED|95.0|-1672.0|-268.0|||Repeated Measures||Repeated measures model includes treatment group, stratification factor, scheduled visit, interaction of treatment with scheduled visit and the baseline value as covariates.|||-268|-1672|0.0069
71807731|NCT02858050|143117439|OTHER|||||||0.548306|||||||Chi-squared|||||||0.548306
71807732|NCT03561090|143117440|SUPERIORITY||Least squares (LS) mean difference|0.055||||0.6346|TWO_SIDED|95.0|-0.172|0.281|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.281|-0.172|0.6346
71807733|NCT03561090|143117441|SUPERIORITY||LS Mean Difference|0.035||||0.7101|TWO_SIDED|95.0|-0.151|0.221|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group, and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.221|-0.151|0.7101
71842901|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|0.0|||=|0.969|TWO_SIDED|90.0|-0.3|0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.3|-0.3|=0.969
71842902|NCT04244175|143197898|SUPERIORITY|The CGI-S score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.2|||=|0.344|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||0.1|-0.4|=0.344
71894693|NCT01335971|143311204|SUPERIORITY_OR_OTHER|||||||0.75|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages||||0.75
71807734|NCT03561090|143117442|SUPERIORITY||Difference in percentage of responders|-5.5|||||TWO_SIDED|95.0|-14.7|3.7|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||3.7|-14.7|
71807735|NCT03561090|143117442|SUPERIORITY||Odds Ratio (OR)|0.81||||0.2531|TWO_SIDED|95.0|0.56|1.17|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the CMH tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.17|0.56|0.2531
71894694|NCT01335971|143311204|SUPERIORITY_OR_OTHER|||||||0.49|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages||||0.49
71894695|NCT01335971|143311204|SUPERIORITY_OR_OTHER|||||||0.88|||||||Kruskal-Wallis|||Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages||||0.88
71807736|NCT03561090|143117443|SUPERIORITY||Proportion ratio|0.938||||0.7445|TWO_SIDED|95.0|0.636|1.382||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Proportion Ratio (1500 mg IW-3718 BID + PPI: Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.382|0.636|0.7445
71807737|NCT03561090|143117443|OTHER|Negative binomial model was used to deal with data overdispersion.|Difference in Proportion Ratio|-0.015|||||TWO_SIDED|95.0|-0.103|0.074|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI).|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.074|-0.103|
71807738|NCT04162769|143117445|SUPERIORITY||Least square mean difference|-10.28|STANDARD_ERROR_OF_MEAN|6.605|=|0.1198|TWO_SIDED|95.0|-23.228|2.674|||ANCOVA|||Week 12||2.674|-23.228|=0.1198
71807739|NCT04162769|143117445|SUPERIORITY||Least square mean difference|-8.77|STANDARD_ERROR_OF_MEAN|6.515|=|0.1783|TWO_SIDED|95.0|-21.544|4.002|||ANCOVA|||Week 12||4.002|-21.544|=0.1783
71807740|NCT04162769|143117446|SUPERIORITY||Response Rate Difference|-0.2|STANDARD_ERROR_OF_MEAN|9.34|=|0.9826|TWO_SIDED|95.0|-18.52|18.11|||Cochran-Mantel-Haenszel|||Week 12||18.11|-18.52|=0.9826
71807741|NCT04162769|143117446|SUPERIORITY||Response Rate Difference|13.0|STANDARD_ERROR_OF_MEAN|9.78|=|0.1891|TWO_SIDED|95.0|-6.12|32.21|||Cochran-Mantel-Haenszel|||Week 12||32.21|-6.12|=0.1891
71807742|NCT04162769|143117447|SUPERIORITY||Response Rate Difference|2.2|STANDARD_ERROR_OF_MEAN|7.38|=|0.7694|TWO_SIDED|95.0|-12.29|16.64|||Cochran-Mantel-Haenszel|||Week 12||16.64|-12.29|=0.7694
71807743|NCT04162769|143117447|SUPERIORITY||Response Rate Difference|17.4|STANDARD_ERROR_OF_MEAN|8.47|=|0.045|TWO_SIDED|95.0|0.79|34.0|||Cochran-Mantel-Haenszel|||Week 12||34.00|0.79|=0.0450
71807744|NCT04162769|143117448|SUPERIORITY||Least square mean difference|-14.03|STANDARD_ERROR_OF_MEAN|7.295|=|0.0558|TWO_SIDED|95.0|-28.406|0.352|||Mixed Models Analysis|||Week 12||0.352|-28.406|=0.0558
71807745|NCT04162769|143117448|SUPERIORITY||Least square mean difference|-10.67|STANDARD_ERROR_OF_MEAN|7.134|=|0.1363|TWO_SIDED|95.0|-24.737|3.397|||Mixed Models Analysis|||Week 12||3.397|-24.737|=0.1363
71807746|NCT04162769|143117449|SUPERIORITY||Response Rate Difference|4.2|STANDARD_ERROR_OF_MEAN|11.33|=|0.7143|TWO_SIDED|95.0|-18.0|26.41|||Cochran-Mantel-Haenszel|||Week 12||26.41|-18.00|=0.7143
71894696|NCT01335971|143311204|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages||||0.71
71894697|NCT01335971|143311205|SUPERIORITY_OR_OTHER|||||||0.68|||||||Kruskal-Wallis|||Applies to gene expression of Nrf2 in bronchial epithelial cells||||0.68
71894698|NCT01335971|143311206|SUPERIORITY_OR_OTHER|||||||0.69|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells||||0.69
71894699|NCT01335971|143311206|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells||||<0.01
71894700|NCT01335971|143311207|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells||||0.53
71894701|NCT01335971|143311208|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.||||<0.01
71807747|NCT04162769|143117449|SUPERIORITY||Response Rate Difference|5.1|STANDARD_ERROR_OF_MEAN|11.09|=|0.6488|TWO_SIDED|95.0|-16.62|26.87|||Cochran-Mantel-Haenszel|||Week 12||26.87|-16.62|=0.6488
71807748|NCT04162769|143117450|SUPERIORITY||Response Rate Difference|8.8|STANDARD_ERROR_OF_MEAN|10.22|=|0.3981|TWO_SIDED|95.0|-11.27|28.8|||Cochran-Mantel-Haenszel|||Week 12||28.80|-11.27|=0.3981
71807749|NCT04162769|143117450|SUPERIORITY||Response Rate Difference|15.2|STANDARD_ERROR_OF_MEAN|10.17|=|0.141|TWO_SIDED|95.0|-4.72|35.15|||Cochran-Mantel-Haenszel|||Week 12||35.15|-4.72|=0.1410
71807750|NCT04162769|143117451|SUPERIORITY||Response Rate Difference|8.4|STANDARD_ERROR_OF_MEAN|7.65|=|0.269|TWO_SIDED|95.0|-6.61|23.38|||Cochran-Mantel-Haenszel|||Week 12||23.38|-6.61|=0.2690
71807751|NCT04162769|143117451|SUPERIORITY||Response Rate Difference|4.3|STANDARD_ERROR_OF_MEAN|7.09|=|0.5428|TWO_SIDED|95.0|-9.56|18.25|||Cochran-Mantel-Haenszel|||Week 12||18.25|-9.56|=0.5428
71807752|NCT04162769|143117452|SUPERIORITY||Least square mean difference|-2.81|STANDARD_ERROR_OF_MEAN|7.721|=|0.7163|TWO_SIDED|95.0|-18.089|12.466|||Mixed Models Analysis|||Week 12||12.466|-18.089|=0.7163
71807753|NCT04162769|143117452|SUPERIORITY||Least square mean difference|-13.24|STANDARD_ERROR_OF_MEAN|7.602|=|0.084|TWO_SIDED|95.0|-28.284|1.805|||Mixed Models Analysis|||Week 12||1.805|-28.284|=0.0840
71807754|NCT00386880|143117469|SUPERIORITY_OR_OTHER|||||||0.59||||||Fisher's exact test.|Fisher Exact|||During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.||||0.59
71807755|NCT04149405|143117479|OTHER||Mean Difference (Final Values)|0.01|||<|0.01|TWO_SIDED||||||Kruskal-Wallis|||||||<0.01
71807756|NCT04149405|143117480|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71807757|NCT04149405|143117481|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71807758|NCT04149405|143117482|OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71894702|NCT01335971|143311209|SUPERIORITY_OR_OTHER|||||||0.06|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.||||0.06
71894703|NCT01335971|143311210|SUPERIORITY_OR_OTHER|||||||0.2|||||||Kruskal-Wallis|||||||0.20
71894704|NCT01335971|143311211|SUPERIORITY_OR_OTHER|||||||0.41|||||||Kruskal-Wallis|||Applies to C-reactive protein concentration||||0.41
71894705|NCT01335971|143311211|SUPERIORITY_OR_OTHER|||||||0.07|||||||Kruskal-Wallis|||Applies to Interleukin-6 concentration||||0.07
71894706|NCT01335971|143311211|SUPERIORITY_OR_OTHER|||||||0.65|||||||Kruskal-Wallis|||Applies to Interleukin-8 concentration||||0.65
71894707|NCT01335971|143311212|SUPERIORITY_OR_OTHER|||||||0.71|||||||Kruskal-Wallis|||Applies to interleukin-8 results||||0.71
71894708|NCT01335971|143311212|SUPERIORITY_OR_OTHER|||||||0.33|||||||Kruskal-Wallis|||Applies to secretory leukoprotease inhibitor results||||0.33
71894709|NCT01335971|143311213|SUPERIORITY_OR_OTHER|||||||0.8|||||||Kruskal-Wallis|||Applies to isoprostane results.||||0.80
71842903|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.01|TWO_SIDED|90.0|-0.7|-0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 15)|CVL-865 25 mg BID vs Placebo (Day 15)||-0.2|-0.7|=0.010
71842904|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.376|TWO_SIDED|90.0|-0.4|0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID vs Placebo (Day 15)||0.1|-0.4|=0.376
71842905|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.3|||=|0.044|TWO_SIDED|90.0|-0.5|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 15)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 15)||-0.1|-0.5|=0.044
71842906|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 43)|CVL-865 25 mg BID vs Placebo (Day 43)||-0.3|-1.0|=0.005
71842907|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID vs Placebo (Day 43)||0.2|-0.5|=0.549
71842908|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 43)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 43)||-0.1|-0.7|=0.048
71842909|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.6|||=|0.005|TWO_SIDED|90.0|-1.0|-0.3|||Mixed Model for Repeated Measures (MMRM)||CVL-865 25 mg BID - Placebo (Day 71)|CVL-865 25 mg BID vs Placebo (Day 71)||-0.3|-1.0|=0.005
71842910|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.1|||=|0.549|TWO_SIDED|90.0|-0.5|0.2|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID vs Placebo (Day 71)||0.2|-0.5|=0.549
71842911|NCT04244175|143197899|SUPERIORITY|The CGI-I score over time was analyzed using a Mixed Model for Repeated Measures (MMRM) analysis. Treatment group, visit, and the interaction between treatment group and visit was included as fixed factors in the MMRM. Participant was included as a random effect, and an unstructured covariance structure was used for the repeated measures.|LS Mean Difference|-0.4|||=|0.048|TWO_SIDED|90.0|-0.7|-0.1|||Mixed Model for Repeated Measures (MMRM)||CVL-865 7.5 mg BID / 25 mg BID - Placebo (Day 71)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (Day 71)||-0.1|-0.7|=0.048
71842912|NCT04244175|143197900|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.49|||=|0.829|TWO_SIDED|90.0|-4.23|3.26|||ANCOVA||CVL-865 25 mg BID - Placebo|CVL-865 25 mg BID vs Placebo||3.26|-4.23|=0.829
71842913|NCT04244175|143197900|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.2|||=|0.927|TWO_SIDED|90.0|-3.87|3.46|||ANCOVA||CVL-865 7.5 mg BID - Placebo|CVL-865 7.5 mg BID vs Placebo||3.46|-3.87|=0.927
71894710|NCT01335971|143311213|SUPERIORITY_OR_OTHER|||||||0.35|||||||Kruskal-Wallis|||Applies to thiobarbituric acid reactive substances results.||||0.35
71894711|NCT01335971|143311213|SUPERIORITY_OR_OTHER|||||||0.53|||||||Kruskal-Wallis|||Applies to total antioxidants results.||||0.53
71894712|NCT00149214|143311218|SUPERIORITY_OR_OTHER||Percentage of Participants|16.5||||||95.0|10.5|24.2||||||Confidence Interval for pathological complete response in the Pemetrexed treatment arm.||24.2|10.5|
71894713|NCT00149214|143311218|SUPERIORITY_OR_OTHER||Percentage of Participants|20.2||||||95.0|13.4|28.5||||||Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.||28.5|13.4|
71894714|NCT03230097|143311263|OTHER||Hazard Ratio (HR)|0.849||||0.7873|TWO_SIDED|95.0|0.258|2.795|||Regression, Cox|Stratified (by baseline use of antipsychotic medication) Cox proportional hazards model was used. Treatment effect and NAPLS risk score as covariates.|Ratio = BI 409306/placebo.|||2.795|0.258|0.7873
71807759|NCT04109703|143117492|OTHER|The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.|||||<|0.05|||||||Regression, Linear|Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.||Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.||||<0.05
71807760|NCT02167074|143117496|OTHER|The chi-square test (with Yates' correction when appropriate) or the Fisher exact test was used to compare the two needle types|||||<|0.05|||||||Chi-squared|||||||<0.05
71807761|NCT02192502|143117579|NON_INFERIORITY|The non-inferiority delta of a ratio of geometric means is 1.15.|Geometric mean ratio|0.91||||0.15|TWO_SIDED|95.0|0.57|1.44|||generalized linear model|This analysis used linear mixed model with repeated measurements with an unstructured correlation structure.||Assuming that NGAL values follow a log normal distribution as in previous studies with a coefficient of variation of 25%, we need 52 patients per group to have 90% power at the 0.025 significance level to be able to claim non-inferiority of HES to albumin using a non-inferiority delta of a ratio of geometric means of 1.15. After Adjusting for the interim monitoring and five potential dropouts and five pilot patients (which were not included in the analyses), we planned to enroll 140 patients||1.44|0.57|0.15
71807762|NCT02192502|143117580|NON_INFERIORITY|the delta for non-inferiority is 1.15|Risk Ratio (RR)|2.78||||0.92|TWO_SIDED|95.0|0.64|12.1|||Chi-squared|||||12.1|0.64|0.92
71807763|NCT02192502|143117581|NON_INFERIORITY|the non-inferiority delta was 1.15|geometric mean ratio|0.45||||0.002|TWO_SIDED|5.0|0.21|0.95|||Regression, Linear|IL-18 was log-transformed||||0.95|0.21|0.002
71807764|NCT02192502|143117582|NON_INFERIORITY|the delta for non-inferiority is 1.15|geometric mean ratio|0.98||||0.31|TWO_SIDED|95.0|0.45|2.1|||Regression, Linear|IL-18 was log-transformed||||2.10|0.45|0.31
71807765|NCT02192502|143117583|NON_INFERIORITY|The non-inferiority delta was 1.15|Risk Ratio (RR)|0.8|||<|0.001|TWO_SIDED|95.0|0.61|1.03|||Chi-squared|||||1.03|0.61|<0.001
71842914|NCT04244175|143197900|SUPERIORITY|Changes from Baseline in QOLIE-31 Overall Scores was compared using an ANCOVA model with the Baseline score as a covariate and treatment group included in the model as fixed effects in the mITT population. This estimand included available post-Baseline response data that occurred before discontinuation of treatment or the addition of rescue medication.|LS Mean Difference|-0.35|||=|0.859|TWO_SIDED|90.0|-3.57|2.88|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo|CVL-865 7.5 mg BID / 25 mg BID vs Placebo||2.88|-3.57|=0.859
71807766|NCT01869491|143117584|SUPERIORITY||Mean Difference (Final Values)|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.31|-0.11|||Mixed Models Analysis|||||-0.11|-0.31|<0.0001
71807767|NCT01869491|143117585|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0004|TWO_SIDED|95.0|-0.29|-0.08|||Mixed Models Analysis|||||-0.08|-0.29|0.0004
71807768|NCT01869491|143117586|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0001|TWO_SIDED|95.0|-0.32|-0.1|||Mixed Models Analysis|||||-0.10|-0.32|0.0001
71807769|NCT01869491|143117587|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.0004|TWO_SIDED|95.0|-0.32|-0.09|||Mixed Models Analysis|||||-0.09|-0.32|0.0004
71807770|NCT01869491|143117588|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71842915|NCT04244175|143197901|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.013|||=|0.788|TWO_SIDED|90.0|-0.096|0.069|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-2)|CVL-865 25 mg BID vs Placebo (HUI-2)||0.069|-0.096|=0.788
71842916|NCT04244175|143197901|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.077|||=|0.126|TWO_SIDED|90.0|-0.006|0.16|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID vs Placebo (HUI-2)||0.160|-0.006|=0.126
71807771|NCT01869491|143117589|SUPERIORITY|||||||0.0433|||||||Wilcoxon (Mann-Whitney)|||||||0.0433
71807772|NCT01869491|143117590|SUPERIORITY|||||||0.0503|||||||Wilcoxon (Mann-Whitney)|||||||0.0503
71807773|NCT02308748|143117613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.8||||0.025|TWO_SIDED|95.0|-25.2|-14.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.3|-25.2|0.025
71807774|NCT02308748|143117613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.7||||0.025|TWO_SIDED|95.0|-25.2|-14.1||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-14.1|-25.2|0.025
71807775|NCT02308748|143117613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.2||||0.025|TWO_SIDED|95.0|-28.0|-18.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.||-18.3|-28.0|0.025
71807776|NCT02308748|143117613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.5||||0.025|TWO_SIDED|95.0|-25.5|-15.5||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.||-15.5|-25.5|0.025
71807777|NCT02308748|143117614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.025|TWO_SIDED|95.0|-1.0|6.7||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||||6.7|-1|0.025
71807778|NCT02979262|143117615|SUPERIORITY||||||>|0.1|||||||Repeated Measures GLM|Time 2 at 16 weeks||||||>.10
71807779|NCT02979262|143117616|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
71807780|NCT02979262|143117617|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
71807781|NCT02979262|143117618|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
71807782|NCT02979262|143117619|SUPERIORITY||||||>|0.1|||||||GEE|||||||>.10
71807783|NCT02979262|143117620|SUPERIORITY||||||<|0.01|||||||GEE|||||||<.01
71807784|NCT01669122|143117665|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
71842917|NCT04244175|143197901|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.032|||=|0.461|TWO_SIDED|90.0|-0.039|0.103|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-2)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-2)||0.103|-0.039|=0.461
71807785|NCT01669122|143117665|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
71807786|NCT01669122|143117665|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.94|||||TWO_SIDED|90.0|0.91|0.97||||||Null hypothesis considered no difference in the treatments being compared.||0.97|0.91|
71807787|NCT01669122|143117666|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02||||||Null hypothesis considered no difference in the treatments being compared.||1.02|0.93|
71807788|NCT01669122|143117666|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.99|||||TWO_SIDED|90.0|0.94|1.03||||||Null hypothesis considered no difference in the treatments being compared.||1.03|0.94|
71807789|NCT01669122|143117666|NON_INFERIORITY_OR_EQUIVALENCE|Testing Bioequivalence|Treatment Ratio|0.92|||||TWO_SIDED|90.0|0.88|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.88|
71807790|NCT01669122|143117667|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
71807791|NCT01669122|143117667|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.||0.99|0.93|
71807792|NCT01669122|143117667|NON_INFERIORITY_OR_EQUIVALENCE|Testing bioequivalence|Treatment Ratio|0.93|||||TWO_SIDED|90.0|0.9|0.96||||||Null hypothesis considered no difference in the treatments being compared.||0.96|0.90|
71807793|NCT01669122|143117668|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2208|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.2208
71807794|NCT01669122|143117668|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5695|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.25|-0.25|0.5695
71807795|NCT01669122|143117668|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0063|TWO_SIDED|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.||0.50|0.00|0.0063
71807796|NCT00234065|143117671|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin.|Hazard Ratio, log|0.743||||0.0357|TWO_SIDED|95.0|0.564|0.981||The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O'Brien-Fleming method.|Log Rank|||Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke||0.981|0.564|0.0357
71807797|NCT00234065|143117672|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.88||||0.4189|TWO_SIDED|95.0|0.645|1.2|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.200|0.645|0.4189
71807798|NCT00234065|143117673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.4582|TWO_SIDED|95.0|0.675|1.194|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||1.194|0.675|0.4582
71807799|NCT00234065|143117674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.072||||0.86|TWO_SIDED|95.0|0.497|2.313|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||2.313|0.497|0.8600
71807800|NCT00234065|143117675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.799||||0.0437|TWO_SIDED|95.0|0.643|0.994|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.994|0.643|0.0437
71807801|NCT00234065|143117676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.458||||0.0004|TWO_SIDED|95.0|0.296|0.711|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.||0.711|0.296|0.0004
71807802|NCT02477618|143117693|SUPERIORITY||Odds Ratio (OR)|1.056||||0.878|TWO_SIDED|95.0|0.527|2.118|||Regression, Logistic|||||2.118|0.527|0.878
71807803|NCT02477618|143117694|SUPERIORITY||Hazard Ratio (HR)|0.747||||0.636|TWO_SIDED|95.0|0.222|2.507|||Regression, Cox|||||2.507|0.222|0.636
71807804|NCT02477618|143117695|SUPERIORITY||Odds Ratio (OR)|0.623||||0.199|TWO_SIDED|95.0|0.303|1.282|||Regression, Logistic|||||1.282|0.303|0.199
71807805|NCT02477618|143117696|SUPERIORITY||Hazard Ratio (HR)|0.683||||0.328|TWO_SIDED|95.0|0.318|1.466|||Regression, Cox|||||1.466|0.318|0.328
71807806|NCT02477618|143117698|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.339|TWO_SIDED|95.0|0.193|1.763|||Regression, Cox|||||1.763|0.193|0.339
71807807|NCT02477618|143117699|SUPERIORITY||Hazard Ratio (HR)|1.086||||0.817|TWO_SIDED|95.0|0.539|2.189|||Regression, Cox|||||2.189|0.539|0.817
71807808|NCT02477618|143117700|SUPERIORITY||LS Mean Difference|-0.2||||0.567|TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|||||0.5|-0.9|0.567
71842918|NCT04244175|143197901|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|-0.032|||=|0.661|TWO_SIDED|90.0|-0.154|0.089|||ANCOVA||CVL-865 25 mg BID - Placebo (HUI-3)|CVL-865 25 mg BID vs Placebo (HUI-3)||0.089|-0.154|=0.661
71842919|NCT04244175|143197901|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.115|||=|0.124|TWO_SIDED|90.0|-0.008|0.237|||ANCOVA||CVL-865 7.5 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID vs Placebo (HUI-3)||0.237|-0.008|=0.124
71842920|NCT04244175|143197901|SUPERIORITY|The Least Square Means (LS Means), difference in LS Means, 90% confidence interval for the difference, and the p-value for the difference are from an analysis of covariance (ANCOVA) model with fixed effects for treatment and Baseline score.|LS Mean Difference|0.041|||=|0.518|TWO_SIDED|90.0|-0.064|0.146|||ANCOVA||CVL-865 7.5 mg BID / 25 mg BID - Placebo (HUI-3)|CVL-865 7.5 mg BID / 25 mg BID vs Placebo (HUI-3)||0.146|-0.064|=0.518
71842921|NCT03781089|143197930|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71842922|NCT03781089|143197931|OTHER|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71842923|NCT01880515|143197948|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.17|0.99||||||||0.99|0.17|
71842924|NCT01880515|143197951|SUPERIORITY|||||||0.41|||||||Log Rank|||||||0.41
71842925|NCT04734197|143197952|SUPERIORITY|||||||0.004||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||Exploratory Phase 2 Study; the sample size of approximately 280-350 subjects (between 40 and 50 subjects per each of the 7 treatment groups) was based on medical judgement.||||0.0040
71842926|NCT04734197|143197953|SUPERIORITY|||||||0.3111|||||||Fisher Exact|The threshold for statistical significance is p=0.05.||"Mixed Model for Repeated Measures (MMRM) analysis included fixed effects of baseline TBUT, age, treatment, visit, and treatment by visit interaction.~Least squares means (LSMs) of the absolute TBUT change from baseline and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.3111
71842927|NCT04734197|143197954|SUPERIORITY|||||||0.2027||||||The threshold for statistical significance is p=0.05.|Fisher Exact|||"MMRM analysis included fixed effects of baseline Schirmer test score, age, treatment, visit, and treatment by visit interaction.~LSMs of the absolute change from baseline in Schirmer test score and their 95% CIs were estimated from the MMRM model for each treatment group."||||0.2027
71842928|NCT04310423|143197955|OTHER|||||||0.036|||||||Mixed Models Analysis|||Treatment x Time interaction for alcohol cue-induced alcohol craving.||||0.036
71842929|NCT04310423|143197956|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Two-way Treatment x Time interaction||||>0.05
71842930|NCT04310423|143197957|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
71842931|NCT04310423|143197958|OTHER||||||>|0.05|||||||Mixed Models Analysis|||Treatment x Time interactions||||>0.05
71842932|NCT04310423|143197959|OTHER||||||<|0.001|||||||ANCOVA|||Main effect of treatment on alcohol cue-elicited brain activation||||<0.001
71842933|NCT04704869|143197981|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|0.81|
71842934|NCT03547271|143198038|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>1/1.5 for all 4 serogroups.|GMT ratio|0.69|||||TWO_SIDED|95.0|0.565|0.842|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup A||0.842|0.565|
71842935|NCT03547271|143198038|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|4.73|||||TWO_SIDED|95.0|4.0|5.58|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup C||5.58|4.00|
71842936|NCT03547271|143198038|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|Slope|1.54|||||TWO_SIDED|95.0|1.33|1.78|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup W||1.78|1.33|
71842937|NCT03547271|143198038|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>1/1.5 for all 4 serogroups.|GMT ratio|1.78|||||TWO_SIDED|95.0|1.55|2.04|||||95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers.|Statistical analysis for Serogroup Y||2.04|1.55|
71842938|NCT03547271|143198039|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|-12.2|||||TWO_SIDED|95.0|-17.74|-6.56|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup A||-6.56|-17.74|
71842939|NCT03547271|143198039|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|6.89|||||TWO_SIDED|95.0|4.44|9.62|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup C||9.62|4.44|
71842940|NCT03547271|143198039|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|2.07|||||TWO_SIDED|95.0|-0.49|4.7|||||95% CI of the difference was calculated from the Wilson score method without continuity correction|Statistical analysis for Serogroup W||4.70|-0.49|
71842941|NCT03547271|143198039|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all 4 serogroups.|Difference in percentage of participants|3.01|||||TWO_SIDED|95.0|0.34|5.77|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|Statistical analysis for Serogroup Y||5.77|0.34|
71842942|NCT04835363|143198056|SUPERIORITY|||||||0.029|||||||ANOVA|||||||0.029
71807809|NCT00936390|143117707|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.22|TWO_SIDED|95.0|0.65|1.11||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|This study was designed to detect an improvement in the 5-year overall survival rate from 90% (radiation alone arm) to 93.3% (radiation and androgen deprivation arm). Assuming an exponential survival distribution for each arm, this translates to a 34% relative reduction (hazard ratio 0.66) in the yearly death rate. At least 218 deaths provide 85% power with a 1-sided significance level of 0.025 and 85% power.||1.11|0.65|0.22
71807810|NCT00936390|143117708|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
71807811|NCT00936390|143117708|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
71807812|NCT00936390|143117709|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.02|TWO_SIDED|95.0|0.22|0.9||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.90|0.22|0.020
71807813|NCT00936390|143117709|SUPERIORITY|Cumulative incidence model||||||0.021||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||||||0.021
71807814|NCT00936390|143117711|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.57||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.57|0.11|<0.001
71807815|NCT00936390|143117711|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
71807816|NCT00936390|143117712|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0073|TWO_SIDED|95.0|0.01|0.8||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.80|0.01|0.0073
71807817|NCT00936390|143117712|SUPERIORITY|||||||0.007||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.007
71807818|NCT00936390|143117713|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.52|TWO_SIDED|95.0|0.7|1.2||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||1.20|0.70|0.52
71807819|NCT00936390|143117713|SUPERIORITY|||||||0.56||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.56
71807820|NCT00936390|143117714|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.025|TWO_SIDED|95.0|0.41|0.95||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.95|0.41|0.025
71807821|NCT00936390|143117714|SUPERIORITY|||||||0.025||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||0.025
71807822|NCT00936390|143117716|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71807823|NCT00936390|143117717|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.13|TWO_SIDED|95.0|0.89|1.53||One-sided significance level 0.025 (reported p-value is one-sided)|Gray's test||Reference level = radiation therapy alone arm|||1.53|0.89|0.13
71807824|NCT00936390|143117718|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.7||One-sided significance level 0.025 (reported p-value is two-sided)|Log Rank||Reference level = radiation therapy alone arm|Cause-specific hazard model||0.70|0.39|<0.001
71807825|NCT00936390|143117718|SUPERIORITY||||||<|0.001||||||One-sided significance level 0.025 (reported p-value is two-sided)|Gray's test|||Cumulative incidence model||||<0.001
71807826|NCT00936390|143117719|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||End of RT||||0.38
71807827|NCT00936390|143117719|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||6 months post-RT||||0.032
71807828|NCT00936390|143117719|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||One year post-RT||||0.87
71807829|NCT00936390|143117719|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Five years post-RT||||0.67
71807830|NCT00936390|143117720|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||End of RT||||0.58
71807831|NCT00936390|143117720|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Six months post-RT||||0.31
71807832|NCT00936390|143117720|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||One year post-RT||||0.36
71807833|NCT00936390|143117720|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Five years post-RT||||0.88
71807834|NCT00936390|143117721|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
71807835|NCT00936390|143117721|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
71807836|NCT00936390|143117721|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||One year post-RT||||<0.001
71807837|NCT00936390|143117721|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Five years post-RT||||0.18
71807838|NCT00936390|143117722|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||End of RT||||<0.001
71807839|NCT00936390|143117722|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Six months post-RT||||<0.001
71807840|NCT00936390|143117722|SUPERIORITY|||||||0.0014|||||||t-test, 2 sided|||One year post-RT||||0.0014
71807841|NCT00936390|143117722|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Five years post-RT||||0.90
71807842|NCT00936390|143117723|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||End of RT||||0.046
71807843|NCT00936390|143117723|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||6 months post-RT||||0.82
71807844|NCT00936390|143117723|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||One year post-RT||||0.82
71807845|NCT00936390|143117723|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Five years post-RT||||0.79
71807846|NCT05520138|143117733|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|1.04|1.16|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.16|1.04|
71807847|NCT05520138|143117734|SUPERIORITY|With a 2-sided Type I of 0.05 significance.|Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|1.06|1.27|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.27|1.06|
71807848|NCT05520138|143117735|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.99|1.1|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.10|0.99|
71842943|NCT04835363|143198057|SUPERIORITY|||||||0.148|||||||ANOVA|||||||0.148
71842944|NCT04835363|143198058|SUPERIORITY|||||||0.012|||||||ANOVA|||||||0.012
71842945|NCT04835363|143198059|SUPERIORITY|||||||0.078|||||||ANOVA|||||||0.078
71842946|NCT04835363|143198060|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
71842947|NCT04835363|143198061|SUPERIORITY|||||||0.797|||||||ANOVA|||||||0.797
71842948|NCT04835363|143198062|SUPERIORITY|||||||0.358|||||||ANOVA|||||||0.358
71842949|NCT04835363|143198063|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
71842950|NCT04835363|143198064|SUPERIORITY|||||||0.496|||||||ANOVA|||||||0.496
71842951|NCT04835363|143198065|SUPERIORITY|||||||0.241|||||||ANOVA|||||||0.241
71842952|NCT04835363|143198066|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
71842953|NCT04835363|143198067|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
71842954|NCT04835363|143198068|SUPERIORITY|||||||0.141|||||||ANOVA|||ENGAGEMENT STRATEGIES||||0.141
71842955|NCT04835363|143198068|SUPERIORITY|||||||0.496|||||||ANOVA|||DISENGAGEMENT STRATEGIES||||0.496
71894715|NCT03230097|143311265|OTHER||Adjusted mean difference|1.77||||0.5212|TWO_SIDED|95.0|-3.773|7.315|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 24. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||7.315|-3.773|0.5212
71807849|NCT05520138|143117736|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|1.06|1.22|||||A weighted Cox proportional hazard model with an independent variable for treatment group were fitted, using a robust variance estimator.|||1.22|1.06|
71807850|NCT00240487|143117742|NON_INFERIORITY_OR_EQUIVALENCE|The primary outcome variable is the mean PaO2/FiO2 in each group after 8 hours of study participation to determine whether timing of treatment with nitric oxide impacts outcome (immediate treatment versus delayed treatment).|||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||Differences in mean PaO2/FiO2 ratios between the two groups will help to determine whether order of therapy (immediate treatment with nitric oxide versus delayed treatment with nitric oxide) impacts outcomes.||||>0.05
71807851|NCT01258608|143117744|OTHER||Hazard Ratio (HR)|1.192||||0.7382|ONE_SIDED|90.0||1.737||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.737||0.7382
71807852|NCT01258608|143117745|OTHER||Hazard Ratio (HR)|0.922||||0.3156|ONE_SIDED|90.0||1.288||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.288||0.3156
71807853|NCT01258608|143117746|OTHER||Hazard Ratio (HR)|1.007||||0.6121|ONE_SIDED|90.0||1.346||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.346||0.6121
71807854|NCT01258608|143117747|OTHER||Hazard Ratio (HR)|1.066||||0.6925|ONE_SIDED|90.0||1.43||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.430||0.6925
71807855|NCT01258608|143117748|OTHER||Hazard Ratio (HR)|0.909||||0.3088|ONE_SIDED|90.0||1.191||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.|||1.191||0.3088
71807856|NCT01258608|143117749|OTHER||Response rate difference|5.4||||0.5458|TWO_SIDED|95.0|-16.8|26.6||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.6|-16.8|0.5458
71807857|NCT01258608|143117750|OTHER||Response rate difference|6.7||||0.3479|TWO_SIDED|95.0|-13.4|26.2||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||26.2|-13.4|0.3479
71807858|NCT01258608|143117751|OTHER||Disease control rate difference|-20.7||||0.0198|TWO_SIDED|95.0|-40.8|1.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||1.8|-40.8|0.0198
71807859|NCT01258608|143117752|OTHER||Disease control rate difference|-5.8||||0.6558|TWO_SIDED|95.0|-25.4|13.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact|||||13.8|-25.4|0.6558
71807860|NCT04098939|143117766|EQUIVALENCE|Bland-Altman plots|Bland-Altman plots|0.39|||<|0.05|TWO_SIDED|95.0|0.26|1.04||Analysis of Bland-Altman plots|Bland-Altman plots|Analysis of Bland-Altman plots|||Analysis of Bland-Altman plots|1.04|0.26|<0.05
71807861|NCT02943408|143117767|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||.90
71807862|NCT02943408|143117768|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||.99
71807863|NCT02943408|143117769|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
71807864|NCT02943408|143117770|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||||||.85
71807865|NCT02943408|143117771|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||.43
71807866|NCT02943408|143117772|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||.82
71807867|NCT02943408|143117773|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||.50
71807868|NCT02943408|143117774|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||.56
71807869|NCT02943408|143117775|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||.92
71807870|NCT02943408|143117776|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
71807871|NCT02943408|143117777|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||||||.35
71677341|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.467|||||TWO_SIDED|95.0|0.311|0.7||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.7|0.311|
71807872|NCT02314624|143117787|SUPERIORITY|||||||0.734||||||Analyses were performed on each subscale individually. This is the p-value for the Depression subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.734
71807873|NCT02314624|143117787|SUPERIORITY|||||||0.27||||||Analyses were performed on each subscale individually. This is the p-value for the Anxiety subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.27
71807874|NCT02314624|143117787|SUPERIORITY|||||||0.75||||||Analyses were performed on each subscale individually. This is the p-value for the Stress subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used a Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.75
71807875|NCT02314624|143117787|SUPERIORITY|||||||0.812||||||Analyses were performed on each subscale individually. This is the p-value for the Suicide subscale.|Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.812
71807876|NCT02314624|143117788|SUPERIORITY|||||||0.036|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.036
71807877|NCT02314624|143117789|SUPERIORITY|||||||0.664|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.664
71807878|NCT02314624|143117790|SUPERIORITY|||||||0.764|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.764
71807879|NCT02314624|143117791|SUPERIORITY|||||||0.44|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.440
71807880|NCT02314624|143117792|SUPERIORITY|||||||0.09|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.09
71807881|NCT02314624|143117793|SUPERIORITY|||||||0.19|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.19
71807882|NCT02314624|143117794|SUPERIORITY|||||||0.15|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.15
71807883|NCT02314624|143117795|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 1 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
71807884|NCT02314624|143117796|SUPERIORITY|||||||0.14|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.14
71807885|NCT02314624|143117797|SUPERIORITY|||||||0.22|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.22
71807886|NCT02314624|143117798|SUPERIORITY||||||<|0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||<.001
71807887|NCT02314624|143117799|SUPERIORITY|||||||0.001|||||||Chi-squared|GEE Type III chi squared distribution with 3 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.001
71807888|NCT02314624|143117800|SUPERIORITY|||||||0.99|||||||Chi-squared|GEE Type III chi squared distribution with 2 degrees of freedom was used to examine between-condition change over time from baseline.||We used the Generalized Linear Model to examine the between-condition change over time on study outcomes. We computed the design effects due to this nested design to determine the extent to which the intraclass correlation due to clustering and size of the cluster affected the analyses. Design effects ranged up to 1.8. Because all were under 2.0, we did not adjust analyses to account for clustering effects.||||.99
71807889|NCT00605293|143117806|SUPERIORITY_OR_OTHER|||||||0.4778|||||||Fisher Exact|||||||0.4778
71807890|NCT02163733|143117822|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%.|Geometric mean ratio|106.05|||||TWO_SIDED|90.0|94.82|118.6|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||118.60|94.82|
71807891|NCT02163733|143117823|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CIs being within 70% to 143%|Geometric mean ratio|92.75|||||TWO_SIDED|90.0|81.4|105.68|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.||105.68|81.40|
71807892|NCT02163733|143117831|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|81.15|||||TWO_SIDED|90.0|57.86|113.83|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.|AZ5104||113.83|57.86|
71807893|NCT02163733|143117831|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|88.21|||||TWO_SIDED|90.0|65.21|119.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.|AZ7550||119.32|65.21|
71807894|NCT02163733|143117832|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|76.68|||||TWO_SIDED|90.0|55.31|106.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.|AZ5104||106.32|55.31|
71807895|NCT02163733|143117832|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|82.92|||||TWO_SIDED|90.0|60.99|112.74|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.|AZ7550||112.74|60.99|
71807896|NCT02633800|143117855|OTHER|Both Log-rank test and Cox regression analysis did not adjust stratification factors.|Hazard Ratio (HR)|0.9291||||0.8342|TWO_SIDED|95.0|0.4856|1.7778||Unstratified Log-rank p-value|Log Rank|||Heregulin-high population - Patritumab vs Placebo||1.7778|0.4856|0.8342
71807897|NCT00464815|143117884|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|7.87|||||TWO_SIDED|95.0|1.63|14.87||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.87|1.63|
71807898|NCT00464815|143117884|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate Difference|0.67|||||TWO_SIDED|95.0|-1.65|4.18||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||4.18|-1.65|
71807899|NCT00464815|143117884|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|8.9|||||TWO_SIDED|95.0|4.78|14.14||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||14.14|4.78|
71807900|NCT00464815|143117884|NON_INFERIORITY|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference \[Nimenrix Group minus Mencevax ACWY Group\] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|15.22|||||TWO_SIDED|95.0|9.89|21.37||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.||21.37|9.89|
71807901|NCT00464815|143117885|NON_INFERIORITY|Criterion for non-inferiority: the upper limit (UL) of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to (≤) the pre-defined clinical limit of 3.0.|Risk Ratio (RR)|4.02||||0.1456|TWO_SIDED|95.0|0.68|24.6|||Chi-squared|||To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.||24.6|0.68|0.1456
71807902|NCT00000392|143117904|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||ANOVA|||||||0.18
71894716|NCT03230097|143311265|OTHER||Adjusted mean difference|3.18||||0.3127|TWO_SIDED|95.0|-3.071|9.425|||Mixed Models Analysis||Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM), see endpoint description for details.|BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||9.425|-3.071|0.3127
71807903|NCT04386096|143117906|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71807904|NCT04386096|143117908|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change in Adolescent Pre-Intention Factors||||0.30
71807905|NCT04386096|143117908|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Change in Parent Pre-Intention Factors||||0.71
71807906|NCT04386096|143117909|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Change in Adolescent Intention to take/give ADHD medicine regularly||||0.29
71807907|NCT04386096|143117909|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||Change in Parent Intention to take/give ADHD medicine regularly||||0.19
71807908|NCT04386096|143117910|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
71807909|NCT04386096|143117911|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||0.81
71807910|NCT04386096|143117913|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Adolescent: Child Seek||||0.10
71807911|NCT04386096|143117913|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Change in Adolescent: Child Express||||0.51
71807912|NCT04386096|143117913|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||Change in Adolescent: Parent Seek||||0.84
71807913|NCT04386096|143117913|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||Change in Adolescent: Parent Express||||0.93
71807914|NCT04386096|143117913|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Change in Adolescent: Joint/Options||||0.43
71807915|NCT04386096|143117913|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Change in Parent: Child Seek||||0.94
71807916|NCT04386096|143117913|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Change in Parent: Child Express||||0.79
71807917|NCT04386096|143117913|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Change in Parent: Parent Seek||||0.61
71807918|NCT04386096|143117913|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Change in Parent: Parent Express||||0.10
71807919|NCT04386096|143117913|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||Change in Parent: Joint/Options||||0.98
71807920|NCT04402866|143117915|OTHER||Common Odds Ratio|1.142||||0.6137|TWO_SIDED|95.0|0.706|1.846|||Van Elteren test||Common Odds Ratio (TD-0903 vs. placebo) and corresponding 95% Wald confidence interval (CI) were obtained from the proportional odds regression model of RFD adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.||1.846|0.706|0.6137
71894717|NCT03230097|143311266|OTHER||Adjusted mean difference|-4.99||||0.1602|TWO_SIDED|95.0|-12.033|2.057|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.057|-12.033|0.1602
71894718|NCT03230097|143311267|OTHER||Adjusted mean difference|-0.8||||0.5858|TWO_SIDED|95.0|-3.749|2.153|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, positive items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||2.153|-3.749|0.5858
71894719|NCT03230097|143311267|OTHER||Adjusted mean difference|1.43||||0.3445|TWO_SIDED|95.0|-1.604|4.462|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, negative items score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||4.462|-1.604|0.3445
71894720|NCT03230097|143311267|OTHER||Adjusted mean difference|1.71||||0.7154|TWO_SIDED|95.0|-7.772|11.196|||Mixed Models Analysis|||BI 409306 vs. placebo of change from baseline at week 52, total score. Restricted maximum likelihood (REML) mixed effects model with repeated measurements (MMRM) including fixed, categorical effects of treatment, visit, treatment by visit interaction, baseline North American Prodromal Longitudinal Study (NAPLS) risk score, baseline use of antipsychotic medication and continuous fixed covariates of baseline score and baseline-by-visit interaction.||11.196|-7.772|0.7154
71807921|NCT04402866|143117916|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|LS mean difference|-0.51||||0.962|TWO_SIDED|95.0|-21.95|20.92|||Mixed model repeated measures model|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||20.92|-21.95|0.962
71807922|NCT04402866|143117917|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.153||||0.5918|TWO_SIDED|95.0|0.692|1.922|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 7||1.922|0.692|0.5918
71807923|NCT04402866|143117917|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.105||||0.6978|TWO_SIDED|95.0|0.651|1.878|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 14|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|1.878|0.651|0.6978
71807924|NCT04402866|143117917|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.295||||0.399|TWO_SIDED|95.0|0.702|2.388|||Van Elteren test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 21|Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|2.388|0.702|0.3990
71807925|NCT04402866|143117917|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Odds Ratio (OR)|1.18||||0.6445|TWO_SIDED|95.0|0.605|2.299|||Van Elteren test||Between-group comparisons analyzed using a proportional odds model adjusting for baseline age strata (≤ 60 years vs. \> 60 years).|Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group on Day 28||2.299|0.605|0.6445
71807926|NCT04402866|143117918|OTHER|Since this was a Phase 2 study, it was not powered for any of the secondary endpoints.|Risk Difference (RD)|5.06||||0.3005|TWO_SIDED|95.0|-4.5|14.63||The p-value was calculated using the Cochran-Mantel-Haenszel chi-square test stratified by baseline age group (≤ 60 years vs. \> 60 years)|Cochran-Mantel-Haenszel chi-square test|||Part 2: TD-0903 - Parallel-Group 3 mg versus Part 2: Matching Placebo - Parallel-Group||14.63|-4.50|0.3005
71807927|NCT01992380|143117926|OTHER||ICC|0.971|||||TWO_SIDED|95.0|0.935|0.988|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.988|0.935|
71807928|NCT01992380|143117927|OTHER||ICC|0.968|||||TWO_SIDED|95.0|0.926|0.986|||||Assessed the agreement between the test and retest imaging of the combination VOI SUVr|Intraclass correlation coefficient \[ICC(2,1)\] analysis from Shrout and Fleiss||0.986|0.926|
71807929|NCT01814371|143117928|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.757|||||||Fisher Exact|||||||0.757
71807930|NCT01814371|143117929|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
71894721|NCT00749606|143311272|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Mixed linear models analyzed within-subject variation in repeated measures over time. Intention to treat analysis used 5 imputations for missing data.||||||<0.01
71807931|NCT01814371|143117930|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.687|||||||Fisher Exact|||||||0.687
71807932|NCT01814371|143117931|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
71807933|NCT01814371|143117932|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.811|||||||Fisher Exact|||||||0.811
71807934|NCT01814371|143117933|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.004|||||||Fisher Exact|||||||0.004
71807935|NCT01814371|143117934|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.006|||||||Fisher Exact|||||||0.006
71807936|NCT01814371|143117935|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.05|||||||Fisher Exact|||||||0.050
71807937|NCT01814371|143117936|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.007|||||||Fisher Exact|||||||0.007
71807938|NCT01814371|143117937|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.005|||||||Fisher Exact|||||||0.005
71807939|NCT01814371|143117938|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||1|||||||Fisher Exact|||||||1.00
71807940|NCT01814371|143117939|EQUIVALENCE|testing equivalence of before and after decolonization protocol.||||||0.84|||||||Chi-squared|||||||0.84
71807941|NCT01814371|143117941|NON_INFERIORITY|testing non-inferiority of individualized approach compared to household approach.||||||0.381|||||||Fisher Exact|||||||0.381
71807942|NCT01814371|143117942|EQUIVALENCE|testing equivalence of individualized approach compared to household approach.||||||0.143|||||||Fisher Exact|||||||0.143
71807943|NCT03252587|143117945|SUPERIORITY||Odds Ratio (OR)|2.8||||0.0006|TWO_SIDED|95.0|1.5|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.5|0.0006
71842956|NCT02532621|143198077|NON_INFERIORITY|"Cumulative patency at 6 months was evaluated using the estimated patency from a Kaplan Meier survival analysis. The test statistic took the following form:~Z-test statistic = (P - 0.75) / SE (P) Where, (P) represents the Kaplan Meier estimate of cumulative patency at 6 months, and the standard error SE (P) is estimated using the method of Peto et al (1977)."|Cumulative patency|92.1|||<|0.001|ONE_SIDED|95.0||||A one-sided p-value of 0.025 was considered evidence of statistical significance for the primary study endpoint.|one-sided binomial exact test|||"The primary endpoint was evaluated by comparison with a performance goal of 75% that was determined from medical literature.~The sample size of 158 patients was estimated as follows:~* Kaplan-Meier estimate of cumulative patency rate at 6 months (exact binomial estimation for sample size)~* Type I error (alpha): 0.025 (one-sided)~* 80% Statistical power~* 8% Lost-to-follow up rate"||||<0.001
71842957|NCT02360371|143198083|SUPERIORITY|||||||0.567|||||||Mixed methods|||||||0.567
71842958|NCT02360371|143198084|SUPERIORITY|||||||0.805|||||||Mixed Model|||||||0.805
71807944|NCT03252587|143117945|SUPERIORITY||Odds Ratio (OR)|1.9||||0.021|TWO_SIDED|95.0|1.0|3.4|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.4|1.0|0.0210
71807945|NCT03252587|143117945|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0781|TWO_SIDED|95.0|0.8|2.9|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||2.9|0.8|0.0781
71807946|NCT03252587|143117946|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0011|TWO_SIDED|95.0|1.4|4.8|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||4.8|1.4|0.0011
71842959|NCT04881110|143198098|SUPERIORITY||Mean Difference (Final Values)|11.2|||<|0.001|TWO_SIDED|95.0|8.0|14.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|14.5|8.0|<0.001
71807947|NCT03252587|143117946|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0434|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.1|0.9|0.0434
71807948|NCT03252587|143117946|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0439|TWO_SIDED|95.0|0.9|3.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.1|0.9|0.0439
71807949|NCT03252587|143117947|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0012|TWO_SIDED|95.0|1.4|5.1|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||5.1|1.4|0.0012
71807950|NCT03252587|143117947|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0795|TWO_SIDED|95.0|0.8|3.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||3.0|0.8|0.0795
71807951|NCT03252587|143117947|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0673|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||3.2|0.9|0.0673
71807952|NCT03252587|143117948|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0002|TWO_SIDED|95.0|1.9|8.5|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||8.5|1.9|0.0002
71807953|NCT03252587|143117948|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0371|TWO_SIDED|95.0|0.9|4.5|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||4.5|0.9|0.0371
71807954|NCT03252587|143117948|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0168|TWO_SIDED|95.0|1.1|5.1|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||5.1|1.1|0.0168
71807955|NCT03252587|143117949|SUPERIORITY||Odds Ratio (OR)|10.5||||0.0006|TWO_SIDED|95.0|2.5|43.0|||Regression, Logistic|1-sided||BMS-986165 3 mg vs Placebo||43.0|2.5|0.0006
71807956|NCT03252587|143117949|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0058|TWO_SIDED|95.0|1.5|22.0|||Regression, Logistic|1-sided||BMS-986165 6 mg vs Placebo||22.0|1.5|0.0058
71807957|NCT03252587|143117949|SUPERIORITY||Odds Ratio (OR)|8.2||||0.0009|TWO_SIDED|95.0|2.2|31.0|||Regression, Logistic|1-sided||BMS-986165 12 mg vs Placebo||31.0|2.2|0.0009
71807958|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.04||0.0131|TWO_SIDED|95.0|-4.4|-0.3|||Longitudinal Repeated Measures|||Tender BMS-986165 3 mg vs Placebo||-0.3|-4.4|0.0131
71807959|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.4156|TWO_SIDED|95.0|-2.3|1.8|||Longitudinal Repeated Measures|||Tender BMS-986165 6 mg vs Placebo||1.8|-2.3|0.4156
71807960|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.09||0.0151|TWO_SIDED|95.0|-4.5|-0.2|||Longitudinal Repeated Measures|||Tender BMS-986165 12 mg vs Placebo||-0.2|-4.5|0.0151
71807961|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.45||0.0029|TWO_SIDED|95.0|-2.2|-0.4|||Longitudinal Repeated Measures|||Swollen BMS-986165 3 mg vs Placebo||-0.4|-2.2|0.0029
71894722|NCT01121406|143311279|SUPERIORITY_OR_OTHER||Difference in Kaplan-Meier DC rates|-12.5|||||TWO_SIDED|95.0|-31.1|6.0|||||"95% CI using Greenwood´s variance estimate.~Volasertib (BI 6727) minus Cytotoxic."|Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood's variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit||6.0|-31.1|
71807962|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.46||0.0516|TWO_SIDED|95.0|-1.6|0.2|||Longitudinal Repeated Measures|||Swollen BMS-986165 6 mg vs Placebo||0.2|-1.6|0.0516
71807963|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.48||0.0298|TWO_SIDED|95.0|-1.8|0.0|||Longitudinal Repeated Measures|||Swollen BMS-986165 12 mg vs Placebo||0.0|-1.8|0.0298
71807964|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.0|-0.5|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 3 mg vs Placebo||-0.5|-2.0|0.0010
71807965|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.0343|TWO_SIDED|95.0|-1.5|0.1|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 6 mg vs Placebo||0.1|-1.5|0.0343
71807966|NCT03252587|143117950|SUPERIORITY||Adjusted Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42||0.005|TWO_SIDED|95.0|-1.9|-0.3|||Longitudinal Repeated Measures|||Tender + Swollen BMS-986165 12 mg vs Placebo||-0.3|-1.9|0.0050
71807967|NCT01515410|143117976|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.86||||0.0471||95.0|-13.62|-0.09||This p-value indicates statistical significance at the 0.05 level.|ANCOVA|No subjects early-terminated from the study.||"Percent OFF Time (%)"||-0.09|-13.62|0.0471
71807968|NCT00868439|143117977|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||< 0.001
71807969|NCT00868439|143117978|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.027|TWO_SIDED||||||Fisher Exact|||||||= 0.027
71807970|NCT00868439|143117979|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED||||||Fisher Exact|||||||= 0.101
71807971|NCT00868439|143117980|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||Fisher Exact|||||||0.022
71807972|NCT00868439|143117981|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.136|TWO_SIDED||||||Fisher Exact|||||||= 0.136
71807973|NCT00868439|143117982|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Fisher Exact|||||||= 0.015
71894723|NCT01121406|143311280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.66|1.53|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.53|0.66|
71894724|NCT01121406|143311281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.63|1.42|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"|||1.42|0.63|
71807974|NCT01654549|143117991|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.94
71807975|NCT01654549|143117991|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||t-test, 2 sided|||||||0.78
71807976|NCT01654549|143117991|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
71807977|NCT01654549|143117991|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Paired t-test|||||||<0.01
71807978|NCT01654549|143117991|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
71807979|NCT05072080|143118023|SUPERIORITY||Mean Difference (Final Values)|96.6|||<|0.0001|TWO_SIDED|95.0|95.0|97.5||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups. All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|Day 22||97.5|95.0|<0.0001
71807980|NCT05072080|143118025|SUPERIORITY||GMT Ratio|206.0|||<|0.0001|TWO_SIDED|95.0|183.0|232.0||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed.|ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo).|Day 22||232|183|<0.0001
71807981|NCT05072080|143118027|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.98|||||TWO_SIDED|95.0|0.85|1.14|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.14|0.85|
71807982|NCT05072080|143118027|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.97|||||TWO_SIDED|95.0|0.84|1.12|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.12|0.84|
71807983|NCT05072080|143118027|EQUIVALENCE|Success criterion was pairwise GMT ratios (104:105, 105:106, 104:106) each with a two-sided 95% CI within \[0.667; 1.5\].|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.1|||||All 3 coprimary endpoints were required to be met for success, so no multiple comparisons were performed. GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.|||1.10|0.82|
71842960|NCT04881110|143198098|SUPERIORITY||Risk Ratio (RR)|1.91|||<|0.001|TWO_SIDED|95.0|1.26|2.9|||Chi-squared||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.90|1.26|<0.001
71842961|NCT04881110|143198099|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.06|TWO_SIDED|95.0|-0.8|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.8|0.06
71842962|NCT04881110|143198100|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.52|TWO_SIDED|95.0|-14.3|7.4|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|7.4|-14.3|0.52
71842963|NCT04881110|143198101|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.33|TWO_SIDED|95.0|-3.6|1.2|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|1.2|-3.6|0.33
71842964|NCT04881110|143198102|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.1|TWO_SIDED|95.0|-1.7|0.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.1|-1.7|0.10
71842965|NCT04881110|143198103|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.8|3.5|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|3.5|-2.8|0.81
71894725|NCT01121406|143311284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.73|1.7|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.70|0.73|
71807984|NCT05072080|143118029|SUPERIORITY||Mean Difference (Final Values)|96.0|||<|0.0001|TWO_SIDED|95.0|94.3|96.8||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 15||96.8|94.3|<0.0001
71807985|NCT05072080|143118029|SUPERIORITY||Mean Difference (Final Values)|84.0|||<|0.0001|TWO_SIDED|95.0|81.7|85.6||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 183||85.6|81.7|<0.0001
71807986|NCT05072080|143118029|SUPERIORITY||Mean Difference (Final Values)|46.1|||<|0.0001|TWO_SIDED|95.0|43.8|48.1||Key secondary endpoints were tested hierarchically, such that each was only tested if all 3 coprimary endpoints and prior key secondary endpoints were met, so no multiple comparisons were performed.|Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|Day 8||48.1|43.8|<0.0001
71807987|NCT05072080|143118031|SUPERIORITY||GMT Ratio|13.0|||<|0.0001|TWO_SIDED|95.0|11.0|14.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 8||14|11|<0.0001
71894726|NCT01121406|143311285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.61|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.61|0.40|
71842966|NCT04881110|143198104|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.99|TWO_SIDED|95.0|-5.8|5.8|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|5.8|-5.8|0.99
71842967|NCT04881110|143198105|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.72|TWO_SIDED|95.0|-32.6|22.9|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|22.9|-32.6|0.72
71842968|NCT04881110|143198106|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.02|TWO_SIDED|95.0|-0.7|-0.07|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|-0.07|-0.7|0.02
71842969|NCT04881110|143198107|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.12|TWO_SIDED|95.0|-0.04|0.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.3|-0.04|0.12
71842970|NCT04881110|143198108|SUPERIORITY||Mean Difference (Final Values)|-3.09||||0.25|TWO_SIDED|95.0|-8.5|2.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.3|-8.5|0.25
71842971|NCT04881110|143198109|SUPERIORITY||Mean Difference (Final Values)|87.4|||<|0.001|TWO_SIDED|95.0|59.9|115.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|115.1|59.9|<0.001
71842972|NCT04881110|143198110|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.18|TWO_SIDED|95.0|-0.09|0.01|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|0.01|-0.09|0.18
71842973|NCT04881110|143198111|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.06|TWO_SIDED|95.0|-0.6|18.1|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|18.1|-0.6|0.06
71842974|NCT04881110|143198112|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.06|TWO_SIDED|95.0|-0.09|2.6|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|2.6|-0.09|0.06
71894727|NCT01121406|143311286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.37|1.65|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.65|0.37|
71894728|NCT01121406|143311287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.93|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.93|0.39|
71894729|NCT01121406|143311288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.33|1.47|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||1.47|0.33|
71894730|NCT01121406|143311289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27|||||TWO_SIDED|95.0|0.09|0.77|||||"Cox proportional-hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"|||0.77|0.09|
71894731|NCT03215277|143311321|SUPERIORITY||Mean Posterior Difference|0.23|||||TWO_SIDED|95.0|-0.14|0.6|||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. The mean posterior difference and 95% credible interval were presented for the BKZ vs CZP comparison.||0.60|-0.14|
71894732|NCT03215277|143311321|SUPERIORITY||PR[Diff > 0%](%)|88.4|||||TWO_SIDED||||||Regression, Linear|||Results were based on a complete case (ie, data as observed) Bayesian linear model with the change from Baseline in ASDAS as the independent variable. Treatment was included as a predictor in the model and Baseline ASDAS as a covariate. Pr\[Diff\>0%\](%) refers to the probability that the mean change from Baseline in ASDAS in the BKZ group was greater than the mean change from Baseline in ASDAS in the CZP group.||||
71807988|NCT05072080|143118031|SUPERIORITY||GMT Ratio|144.0|||<|0.0001|TWO_SIDED|95.0|128.0|162.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 15||162|128|<0.0001
71807989|NCT05072080|143118031|SUPERIORITY||GMT Ratio|41.0|||<|0.0001|TWO_SIDED|95.0|37.0|46.0|||ANOVA|ANOVA model includes site and treatment group as fixed effects, assuming normality of log titers. p-value tests equivalence of group GMTs on log scale|Ratio of GMTs is (PXVX0317:placebo)|Day 183||46|37|<0.0001
71807990|NCT05072080|143118033|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 8||||<0.0001
71807991|NCT05072080|143118033|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 15||||<0.0001
71842975|NCT04881110|143198114|SUPERIORITY||Mean Difference (Final Values)|25.1|||<|0.001|TWO_SIDED|95.0|21.8|28.3|||t-test, 2 sided||||To evaluate the change of variables over time, we subtracted the values at the start from values at the end. A 2-sample t test was used to compare differences between the interventions. The χ2 test was used for comparing proportions of participants in the 2 groups who reached the primary end point after the intervention. Relative risks (RRs) and 95%Cis were calculated to demonstrate the relationship between the intervention and the achievement of the primary end point. A 2-sided P \< .05 was considered statistically significant.|28.3|21.8|<0.001
71842976|NCT02933489|143198147|EQUIVALENCE|H0: DBT = AB-MR|Wald interval with Bonett-Price Laplace|0.007||||0.002|TWO_SIDED|95.0|0.0022|0.0116|||McNemar||"Wald interval with Bonett-Price Laplace, described in :~Fagerland MW, Lydersen S, Laake P. Recommended tests and confidence intervals for paired binomial proportions. Statist. Med. 2014; 33:2850-75."|The proportion of participants who had an invasive cancer, verified by pathology, detected by each modality (the invasive cancer detection rates) will be made using exact McNemar's test.||0.0116|0.0022|0.002
71807992|NCT05072080|143118033|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 22||||<0.0001
71807993|NCT05072080|143118033|SUPERIORITY||||||<|0.0001||||||GMFI estimates and 95% CIs are based on t-statistics assuming a normal distribution of the log fold increase in titer. p-value tests equality of log fold increase in titer between groups.|t-test, 2 sided|||Day 183||||<0.0001
71807994|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|90.7|||<|0.0001|TWO_SIDED|95.0|88.7|91.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 8||91.9|88.7|<0.0001
71807995|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|98.7|||<|0.0001|TWO_SIDED|95.0|97.2|99.3||p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Chi-squared||Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 15||99.3|97.2|<0.0001
71807996|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|97.6|||<|0.0001|TWO_SIDED|95.0|95.8|98.5|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 22||98.5|95.8|<0.0001
71894733|NCT01882725|143311333|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71894734|NCT01882725|143311334|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71894735|NCT01238120|143311337|SUPERIORITY|||||||0.9168|||||||ANCOVA|||||||0.9168
71894736|NCT01238120|143311338|SUPERIORITY|||||||0.6536|||||||ANCOVA|||||||0.6536
71807997|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|96.8|||<|0.0001|TWO_SIDED|95.0|94.8|97.9|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|SNA titers ≥15 at Day 183||97.9|94.8|<0.0001
71807998|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|62.5|66.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 8||66.7|62.5|<0.0001
71807999|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|97.8|||<|0.0001|TWO_SIDED|95.0|96.3|98.4|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 15||98.4|96.3|<0.0001
71808000|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|97.2|||<|0.0001|TWO_SIDED|95.0|95.5|98.1|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 22||98.1|95.5|<0.0001
71894737|NCT02498652|143311372|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||TWO_SIDED|90.0|90.7|117.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||117|90.7|
71894738|NCT02498652|143311372|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.6|||||TWO_SIDED|90.0|78.1|110.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects.||||110|78.1|
71894739|NCT02498652|143311372|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||TWO_SIDED|90.0|85.7|120.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||120|85.7|
71894740|NCT02498652|143311372|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|88.9|||||TWO_SIDED|90.0|78.4|101.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||101|78.4|
71894741|NCT02498652|143311372|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.7|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale||||114|87.7|
71894742|NCT02498652|143311372|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||TWO_SIDED|90.0|85.5|119.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||119|85.5|
71894743|NCT02498652|143311375|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||TWO_SIDED|90.0|94.3|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|94.3|
71894744|NCT02498652|143311375|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.0|||||TWO_SIDED|90.0|90.4|106.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||106|90.4|
71842977|NCT02933489|143198148|EQUIVALENCE|PPV DBT = PPV AB-MR||||||0.15||||||"Generalized estimating equation (GEE) regression with the p-value from the resulting score test.~5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance"|Leisenring|Leisenring W, Alonzo T, Pepe MS. Comparisons of predictive values of binary medical diagnostic tests for paired designs. Biometrics. 2000;56:345-351||Positive Predictive Value (PPV)||||0.15
71842978|NCT02933489|143198149|EQUIVALENCE|H0: DBT short term follow-up rate = AB-MR short term follow-up rate|||||<|0.0001||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5=0.01 corresponding to the 5 secondary comparisons outlined in the Statistical Analysis Plan (SAP)|McNemar|exact p-value||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR short term follow-up rates||||<0.0001
71842979|NCT02933489|143198149|EQUIVALENCE|H0: DBT additional imaging rate =AB-MR additional imaging rate||||||0.02||||||To adjust for multiplicity, using the Bonferroni correction, secondary comparisons are compared against an adjusted alpha level of 0.05/5 = 0.01, corresponding to the 5 secondary comparisons outlined in the SAP|McNemar|exact p-values||The exact p-value from McNemar's test is reported for for comparing the DBT against the AB-MR additional imaging rates||||0.02
71894745|NCT02498652|143311375|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|104.0|||||TWO_SIDED|90.0|94.5|114.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||114|94.5|
71894746|NCT02498652|143311375|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.0|||||TWO_SIDED|90.0|86.7|97.7|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||97.7|86.7|
71894747|NCT02498652|143311375|NON_INFERIORITY|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.9|||||TWO_SIDED|90.0|91.0|107.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||107|91.0|
71894748|NCT02498652|143311375|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%|Geometric Least Squares Mean Ratio (%)|97.5|||||TWO_SIDED|90.0|92.8|102.0|||Mixed Models Analysis|Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.||||102|92.8|
71894749|NCT04207710|143311381|SUPERIORITY|||||||0.317||||||A priori threshold for significance was p\<0.05.|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
71894750|NCT04207710|143311381|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Ethyl Chloride.||||0.317
71842980|NCT02933489|143198150|EQUIVALENCE|Sensitivity DBT = Sensitivity AB-MR||||||0.001||||||The comparison of the sensitivity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||0.001
71894751|NCT04207710|143311381|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
71894752|NCT04207710|143311381|SUPERIORITY|||||||0.317||||||A priori threshold was p\<0.05|Friedman|||Comparison of incidence of positive growth in samples obtained following application of ChloraPrep vs. ChloraPrep followed by Gebauer's Pain Ease.||||0.317
71894753|NCT00095303|143311388|SUPERIORITY_OR_OTHER||slope of linear trajectory of drug use|0.05||||0.27|TWO_SIDED|95.0|-0.04|0.14|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.|Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.||.14|-.04|.27
71894754|NCT00095303|143311390|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.26|TWO_SIDED|95.0|-0.28|0.08|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors||0.08|-0.28|.26
71894755|NCT00095303|143311406|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.21|TWO_SIDED|95.0|0.82|1.09|||GEE|||Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants||1.09|.82|.21
71894756|NCT00095303|143311408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||<|0.006|TWO_SIDED|95.0|-0.71|-0.12|||GEE|||Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors||-.12|-.71|<.006
71894757|NCT00095303|143311409|SUPERIORITY_OR_OTHER||Slope|0.12||||0.015|TWO_SIDED|95.0|0.03|0.22|||Mixed Models Analysis|||Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the 'Parenting Practices Inventory' will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are 'Positive Parenting', 'Discipline Effectiveness,' 'Avoidance of Discipline' and 'Monitoring' scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.||.22|.03|.015
71894758|NCT00095303|143311413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68||||0.12|TWO_SIDED|95.0|-0.18|1.54|||GEE|||||1.54|-.18|.12
71808001|NCT05072080|143118035|SUPERIORITY||Mean Difference (Final Values)|91.4|||<|0.0001|TWO_SIDED|95.0|89.4|92.7|||Chi-squared|p-value is from a two-sided chi-square test of equality of seroresponse percentages between groups.|Seroresponse rate difference is (PXVX0317 minus placebo).|≥4-fold rise over baseline at Day 183||92.7|89.4|<0.0001
71808002|NCT01043432|143118037|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Regression, Linear|||Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.||||>.05
71842981|NCT02933489|143198150|EQUIVALENCE|Specificity DBT = Specificity AB-MR|||||<|0.001||||||The comparison of the Specificity of AB-MR and DBT uses a two-sided exact McNemar's test to account for the paired design 5 secondary comparisons were planned: alpha level of 0.05/5 = 0.01 for p-value significance|McNemar|||||||<0.001
71842982|NCT02994927|143198167|NON_INFERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||<|0.0001|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|< 0.0001
71842983|NCT02994927|143198167|SUPERIORITY|The proportion of subjects achieving disease remission at Week 26 and the two-sided 95% confidence intervals (CIs) for the difference in proportions was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|3.4|||=|0.2387|TWO_SIDED|95.0|-6.0|12.8|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||12.8|-6.0|= 0.2387
71842984|NCT02994927|143198168|NON_INFERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||<|0.0001|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|< 0.0001
71894759|NCT00095303|143311414|SUPERIORITY_OR_OTHER||Slope|0.33||||0.12|TWO_SIDED|95.0|-0.09|0.76|||GEE||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the 'HIV/Sex Risk Behaviors' measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.||.76|-.09|.12
71894760|NCT00095303|143311418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.23|TWO_SIDED|95.0|-0.09|0.37|||GEE|||||.37|-.09|.23
71894761|NCT01499576|143311419|SUPERIORITY_OR_OTHER||percent agreement|89.2|||||TWO_SIDED|||||||||||||
71894762|NCT01499576|143311420|SUPERIORITY_OR_OTHER||Kappa index of agreement|0.808|||<|0.01|TWO_SIDED||||||Kappa index of agreement|||||||<0.01
71894763|NCT01499576|143311421|SUPERIORITY_OR_OTHER||persent of adverse event|10.48|||||TWO_SIDED|||||||||||||
71894764|NCT00397150|143311441|SUPERIORITY_OR_OTHER||Prevalence ratio|2.29|||||TWO_SIDED|95.0|1.33|3.92||||||||3.92|1.33|
71894765|NCT00397150|143311446|SUPERIORITY_OR_OTHER||Prevalence ratio|1.89|||||TWO_SIDED|95.0|1.7|2.11||||||||2.11|1.70|
71894766|NCT00397150|143311447|SUPERIORITY_OR_OTHER||Prevalence ratio|1.72|||||TWO_SIDED|95.0|1.12|2.63||||||||2.63|1.12|
71894767|NCT00195351|143311452|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.009||95.0|-13.1|5.1|||t-test, 2 sided|||||5.1|-13.1|0.009
71894768|NCT00195351|143311453|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.4||||0.02||95.0|-14.5|7.8|||t-test, 2 sided|||||7.8|-14.5|0.020
71808003|NCT01972841|143118049|SUPERIORITY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.12||0.072|TWO_SIDED|95.0|-0.49|-0.01||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.49|0.072
71842985|NCT02994927|143198168|SUPERIORITY|The proportion of subjects achieving sustained disease remission at Week 52, and the two-sided 95% confidence intervals (CIs) for the difference in proportions (avacopan minus prednisone) was estimated for the comparison between the avacopan group and the prednisone group. For both the noninferiority and superiority tests, the one-sided P-values are presented. Statistical significance was claimed based on the one-sided type-I error of 0.025.|Common difference in remission rates|12.5|||=|0.0066|TWO_SIDED|95.0|2.6|22.3|||Summary score test||Summary Score estimate of the common difference and Miettinen-Nurminen (score) confidence limits for the common difference|||22.3|2.6|= 0.0066
71842986|NCT03982186|143198218|SUPERIORITY||Difference of proportions|-2.3|||=|0.848|TWO_SIDED|90.0|-5.97|1.38|||Mantel Haenszel|||||1.38|-5.97|= 0.848
71842987|NCT03982186|143198218|SUPERIORITY||Difference of proportions|7.4|||=|0.027|TWO_SIDED|90.0|1.07|13.68|||Mantel Haenszel|||||13.68|1.07|= 0.027
71842988|NCT03982186|143198218|SUPERIORITY||Difference of proportions|9.1|||=|0.917|TWO_SIDED|90.0|4.16|14.07|||Mantel Haenszel|||||14.07|4.16|= 0.917
71842989|NCT03982186|143198218|SUPERIORITY||Difference of proportions|-6.7|||=|0.917|TWO_SIDED|90.0|-14.67|1.25|||Mantel Haenszel|||||1.25|-14.67|= 0.917
71842990|NCT02777593|143198316|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.64, then the the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.751|||||ONE_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 12-Month imaging performed.~Results were tested against a performance goal (PG) of 0.64 (i.e. 64%), derived from historical GORE TAG® and Conformable TAG® data.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 70 patients. With attrition, 85 patients were required."||||
71842991|NCT05785130|143198318|SUPERIORITY|T0|Mean Difference (Final Values)|-25.07||||0.74|TWO_SIDED|||||T0|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.74
71842992|NCT05785130|143198318|SUPERIORITY||Median Difference (Final Values)|133.57||||0.75|TWO_SIDED|||||T1|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||0.75
71842993|NCT05785130|143198318|SUPERIORITY|T|Median Difference (Final Values)|235.93|||<|0.01|TWO_SIDED|||||T2|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
71842994|NCT05785130|143198318|SUPERIORITY|T3|Median Difference (Final Values)|214.18|||<|0.01|TWO_SIDED|||||T3|t-test, 2 sided|||It was calculated that 58 participants were randomized in a 1:1 between two arms on baseline, the first intervention day(T1), the third intervention day(T2), and follow up two days later after intervention (T3) . Sample size was determoned using G-power repeated measures, between factors(α = 0.05, power = 0.8). Assumption a discontinution rate of 10%.||||<0.01
71842995|NCT03351998|143198319|SUPERIORITY||Mean Difference (Net)|36.02|STANDARD_DEVIATION|365.55||0.6051|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.6051
71842996|NCT03351998|143198319|SUPERIORITY||Mean Difference (Net)|31.89|STANDARD_DEVIATION|213.0||0.9434|TWO_SIDED||||||signed rank test|This is within group 12 month change.||||||0.9434
71842997|NCT03351998|143198319|SUPERIORITY||Mean Difference (Net)|-3.39|STANDARD_DEVIATION|179.54||0.9408|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.9408
71842998|NCT03351998|143198320|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|0.23||0.7458|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.7458
71842999|NCT03351998|143198320|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.16||0.4056|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.4056
71843000|NCT03351998|143198320|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_DEVIATION|0.18||0.1932|TWO_SIDED||||||t-test, 2 sided|This is within group 12 month change.||||||0.1932
71843001|NCT04093869|143198364|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|5.1||0.4|TWO_SIDED|95.0|-6.0|14.0||Not adjusted for multiple comparisons. Full alpha of 0.05 was allocated to this as the sole primary outcome.|Regression, Linear||A negative mean difference would represent a better outcome in the CSTEX arm compared to the SOC-ED arm.|||14|-6|0.40
71843002|NCT04093869|143198365|SUPERIORITY||Mean Difference (Net)|20.7|STANDARD_ERROR_OF_MEAN|32.6|||TWO_SIDED|95.0|-44.0|85.0|||||A positive value for the estimate represents a greater distance walked for the CSTEX arm compared to the SOC-ED arm.|||85|-44|
71843003|NCT04093869|143198366|SUPERIORITY||Median Difference (Net)|-316.0|STANDARD_ERROR_OF_MEAN|336.0|||TWO_SIDED|95.0|-979.0|346.0|||||A positive value for the estimate would represent more steps per day for the CSTEX arm compared to the SOC-ED arm.|||346|-979|
71843004|NCT04093869|143198367|SUPERIORITY||Mean Difference (Net)|14.7|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-5.0|34.0||||||||34|-5|
71843005|NCT04093869|143198368|SUPERIORITY||Mean Difference (Net)|0.0034|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.1|0.11|||||A negative value for the estimate would represent a better QOL survey score for the CSTEX arm compared to the SOC-ED arm.|||0.11|-0.1|
71894769|NCT00195351|143311454|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9||||0.015||95.0|-13.9|8.1|||Method of Mehrotra and Railkar|||||8.1|-13.9|0.015
71808004|NCT01972841|143118049|SUPERIORITY||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.033|TWO_SIDED|95.0|-0.44|0.04||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.04|-0.44|0.033
71808005|NCT01972841|143118049|SUPERIORITY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.001|TWO_SIDED|95.0|-0.58|-0.1|||Stratified rank ANCOVA||Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.58|0.001
71808006|NCT01972841|143118049|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.052|TWO_SIDED|95.0|-0.47|0.01|||Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.47|0.052
71808007|NCT01972841|143118050|SUPERIORITY||Least squares mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.04|TWO_SIDED|95.0|-0.57|-0.01||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.57|0.040
71808008|NCT01972841|143118050|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.006|TWO_SIDED|95.0|-0.67|-0.11||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.67|0.006
71808009|NCT01972841|143118050|SUPERIORITY||Least squares mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.76|-0.21||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.76|0.001
71843006|NCT04093869|143198369|SUPERIORITY||Mean Difference (Net)|0.041|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.22|0.3|||||A negative value for the estimate would represent a better Frailty index score for the CSTEX arm compared to the SOC-ED arm.|||0.30|-0.22|
71843007|NCT04093869|143198370|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.17||||||||0.17|-0.20|
71843008|NCT04093869|143198371|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.13|0.1||||||||0.10|-0.13|
71843009|NCT04093869|143198372|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.12|0.07||||||||0.07|-0.12|
71843010|NCT04093869|143198373|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-0.83|1.6|||||A positive value for the estimate represents better self-efficacy for the CSTEX arm compared to the SOC-ED arm.|||1.60|-0.83|
71843011|NCT04243759|143198408|SUPERIORITY|||||||0.97|||||||ANOVA|||||||0.97
71843012|NCT04243759|143198409|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_DEVIATION|2.09||0.232|TWO_SIDED|95.0|-0.24|0.95|||t-test, 2 sided|||Within subjects comparison of drinks per drinking day with full intervention app access versus daily assessment via the app only||0.95|-0.24|.232
71894770|NCT03322657|143311462|SUPERIORITY||Hazard Ratio (HR)|3.8|||<|0.001|TWO_SIDED|95.0|2.2|6.5|||Cox proportional hazard model|||||6.5|2.2|<0.001
71894771|NCT03322657|143311463|SUPERIORITY||Median Difference (Final Values)|6.3||||0.13|TWO_SIDED|95.0|-2.0|14.0|||Wilcoxon (Mann-Whitney)|||||14|-2.0|0.13
71894772|NCT03322657|143311464|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3|TWO_SIDED|95.0|0.43|1.34|||Cox proportional hazard model|||||1.34|0.43|0.30
71894773|NCT03322657|143311465|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.21|TWO_SIDED|95.0|-0.35|1.0|||t-test, 2 sided|||||1.00|-0.35|0.21
71894774|NCT03322657|143311466|SUPERIORITY||Mean Difference (Final Values)|0.82||||0.04|TWO_SIDED|95.0|-0.18|1.81|||t-test, 2 sided|||||1.81|-0.18|0.04
71894775|NCT00843180|143311482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_DEVIATION|0.0||0.8|TWO_SIDED|95.0|-5.4|4.2||unadjusted|t-test, 2 sided||this was a feasibility pilot study CI is descriptor of dispersion|comparison between groups by t-test||4.2|-5.4|0.80
71894776|NCT00843180|143311483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_DEVIATION|0.0||0.29|TWO_SIDED|95.0|-6.9|2.1||unadjusted|t-test, 2 sided||CI serves as dispersion measure|||2.1|-6.9|0.29
71894777|NCT00843180|143311484|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.8|STANDARD_DEVIATION|0.0||0.78|TWO_SIDED|95.0|-31.9|24.3|||t-test, 2 sided||95% CI is dispersion parameter|||24.3|-31.9|0.78
71894778|NCT00843180|143311485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_DEVIATION|0.0||0.7|TWO_SIDED|95.0|-9.5|13.2|||t-test, 2 sided|unadjusted|95%CI is dispersion measure|||13.2|-9.5|0.70
71894779|NCT01477450|143311486|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.3
71808010|NCT01972841|143118050|SUPERIORITY||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.84|-0.28||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-0.84|<0.001
71894780|NCT01477450|143311486|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
71808011|NCT01972841|143118051|SUPERIORITY||Least squares mean difference|3.85|STANDARD_ERROR_OF_MEAN|3.13||0.219|TWO_SIDED|95.0|-2.29|10.0||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||10.00|-2.29|0.219
71808012|NCT01972841|143118051|SUPERIORITY||Least squares mean difference|8.75|STANDARD_ERROR_OF_MEAN|3.13||0.005|TWO_SIDED|95.0|2.61|14.89||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||14.89|2.61|0.005
71894781|NCT01477450|143311486|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
71894782|NCT03875235|143311502|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.021|TWO_SIDED|97.0|0.64|0.99||The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for OS at the second interim analysis was 3%.|95% CI 0.66 to 0.97|0.99|0.64|0.021
71894783|NCT03875235|143311505|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.001|TWO_SIDED|95.19|0.63|0.89||The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.|The 2-sided significance level for PFS at the second interim analysis was 4.81%.|95% CI 0.63 to 0.89|0.89|0.63|0.001
71894784|NCT03875235|143311508|SUPERIORITY||Odds Ratio (OR)|1.6||||0.011|TWO_SIDED|95.0|1.11|2.31|||Cochran-Mantel-Haenszel||OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.|||2.31|1.11|0.011
71894785|NCT02234622|143311525|SUPERIORITY||Mean Difference (Final Values)|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.002|TWO_SIDED|95.0|-8.2|-1.8|||Mixed Models Analysis|||||-1.8|-8.2|0.002
71894786|NCT02234622|143311526|SUPERIORITY||Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.2||0.005|TWO_SIDED|95.0|-10.3|-1.8|||Mixed Models Analysis|||||-1.8|-10.3|0.005
71894787|NCT02234622|143311527|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|2.6||0.042|TWO_SIDED|95.0|-11.9|-1.6|||Mixed Models Analysis|||||-1.6|-11.9|0.042
71894788|NCT02234622|143311528|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.4||0.482|TWO_SIDED|95.0|-4.2|1.1|||Mixed Models Analysis|||||1.1|-4.2|0.482
71894789|NCT02234622|143311529|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.7||0.635|TWO_SIDED|95.0|-4.7|1.9|||Mixed Models Analysis|||||1.9|-4.7|0.635
71894790|NCT02234622|143311530|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.8||0.367|TWO_SIDED|95.0|-6.0|1.1|||Mixed Models Analysis|||||1.1|-6.0|0.367
71894791|NCT02234622|143311531|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.668|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||||1.0|-0.5|0.668
71894792|NCT03478683|143311572|NON_INFERIORITY|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.0143|||TWO_SIDED|95.0|-0.013|0.043|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.|||0.043|-0.013|
71808013|NCT01972841|143118051|SUPERIORITY||Least squares mean difference|21.52|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|15.35|27.68||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||27.68|15.35|<0.001
71808014|NCT01972841|143118051|SUPERIORITY||Least squares mean difference|17.74|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|11.58|23.9||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||23.90|11.58|<0.001
71808015|NCT01972841|143118052|SUPERIORITY||Least squares mean difference|-4.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-6.98|-2.27|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-2.27|-6.98|<0.001
71808016|NCT01972841|143118052|SUPERIORITY||Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.17|-3.44|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.44|-8.17|<0.001
71894793|NCT03478683|143311573|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0139||0.481|TWO_SIDED|95.0|-0.037|0.018||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2|||0.018|-0.037|0.481
71808017|NCT01972841|143118052|SUPERIORITY||Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-9.5|-4.76|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-4.76|-9.50|<0.001
71808018|NCT01972841|143118052|SUPERIORITY||Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.46|-3.74|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-3.74|-8.46|<0.001
71808019|NCT01972841|143118053|SUPERIORITY||Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.14||0.077|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.52|-0.03|0.077
71808020|NCT01972841|143118053|SUPERIORITY||Least squares mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.14||0.05|TWO_SIDED|95.0|0.0|0.55|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.55|0.00|0.050
71808021|NCT01972841|143118053|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.008|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.008
71808022|NCT01972841|143118053|SUPERIORITY||Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.14||0.007|TWO_SIDED|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.65|0.10|0.007
71894794|NCT03478683|143311573|SUPERIORITY||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.0124|<|0.001|TWO_SIDED|95.0|0.037|0.086||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28|||0.086|0.037|<0.001
71894795|NCT03478683|143311573|SUPERIORITY||Mean Difference (Net)|0.058|STANDARD_ERROR_OF_MEAN|0.0133|<|0.001|TWO_SIDED|95.0|0.032|0.084||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84|||0.084|0.032|<0.001
71808023|NCT01972841|143118054|SUPERIORITY||Rate ratio|0.87|STANDARD_ERROR_OF_MEAN|0.09||0.135|TWO_SIDED|95.0|0.72|1.04|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.04|0.72|0.135
71843013|NCT03816397|143198410|SUPERIORITY|A sample size of 118 subjects (59 in each group) provides 88% power to detect a hazard ratio of 2.0 for the time to treatment failure comparing the group randomized to discontinue adalimumab to the group randomized to continue using adalimumab, assuming a median time until treatment failure of 10 weeks in the group that discontinues adalimumab (Arm 1) and of 20 weeks in the group that continues on adalimumab (Arm 2), an equal allocation between groups, and a 10% total loss to follow-up.|Hazard Ratio (HR)|8.7|||<|0.0001|TWO_SIDED|95.0|3.6|21.2||A priori threshold for statistical significance was \<0.05.|Log Rank||For the HR, the numerator is the placebo group (stop adalimumab) and the denominator is the adalimumab group (continue adalimumab).|A Cox proportional hazards regression was used to compare time to treatment failure between the adalimumab and placebo groups up to the primary endpoint of 48 weeks, with country and conventional DMARD use included as fixed effects in the model. The null hypothesis was an hazard ratio (HR) of 1. Hypothesis testing was based on a permutation test of the log hazard ratio (100,000 replicates). The model was checked for the assumption of proportional hazards by assessing Schoenfeld residuals.||21.2|3.6|<0.0001
71894796|NCT03478683|143311573|SUPERIORITY||Mean Difference (Net)|0.038|STANDARD_ERROR_OF_MEAN|0.014||0.007|TWO_SIDED|95.0|0.01|0.066||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85|||0.066|0.010|0.007
71894797|NCT03478683|143311574|SUPERIORITY||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.011||0.415|TWO_SIDED|95.0|-0.03|0.013||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.013|-0.030|0.415
71808024|NCT01972841|143118054|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.09||0.282|TWO_SIDED|95.0|0.75|1.09|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.09|0.75|0.282
71808025|NCT01972841|143118054|SUPERIORITY||Rate ratio|0.71|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|0.59|0.85|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||0.85|0.59|<0.001
71808026|NCT01972841|143118054|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.1||0.172|TWO_SIDED|95.0|0.73|1.06|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.||1.06|0.73|0.172
71808027|NCT01972841|143118055|SUPERIORITY||least squares mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.83||0.074|TWO_SIDED|95.0|-3.27|-0.01|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.||-0.01|-3.27|0.074
71808028|NCT01972841|143118055|SUPERIORITY||Least squares mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.83||0.025|TWO_SIDED|95.0|-2.96|0.3|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.30|-2.96|0.025
71808029|NCT01972841|143118055|SUPERIORITY||least square mean difference|-2.36|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.0|-0.73|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.73|-4.00|<0.001
71843014|NCT03493542|143198414|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.42|||<|0.0001|TWO_SIDED|95.0|1.28|1.58|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 6||1.58|1.28|<0.0001
71894798|NCT03478683|143311575|SUPERIORITY||Mean Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.0138||0.335|TWO_SIDED|95.0|-0.014|0.04||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|||0.040|-0.014|0.335
71894799|NCT05175170|143311576|OTHER||Mean Difference (Final Values)|-33.902|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
71894800|NCT05175170|143311576|OTHER||Mean Difference (Final Values)|-26.098|||<|0.001|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.||||<.001
71894801|NCT05175170|143311577|OTHER||Mean Difference (Final Values)|-20.202||||0.002|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.002
71894802|NCT05175170|143311577|OTHER||Mean Difference (Final Values)|-8.081||||0.051|TWO_SIDED||||||t-test, 1 sided|||The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.||||0.051
71808030|NCT01972841|143118055|SUPERIORITY||Least squares mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.84||0.024|TWO_SIDED|95.0|-3.23|0.05|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.05|-3.23|0.024
71808031|NCT01972841|143118059|SUPERIORITY||Least squares mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.29||0.52|TWO_SIDED|95.0|-0.39|0.76|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.76|-0.39|0.520
71808032|NCT01972841|143118059|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.413|TWO_SIDED|95.0|-0.82|0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.34|-0.82|0.413
71808033|NCT01972841|143118059|SUPERIORITY||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.29||0.002|TWO_SIDED|95.0|-1.5|-0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.34|-1.50|0.002
71808034|NCT01972841|143118059|SUPERIORITY||Least squares mean diffrence|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.06|TWO_SIDED|95.0|-1.13|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||0.02|-1.13|0.060
71808035|NCT01972841|143118060|SUPERIORITY||Rate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.7|1.04|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.04|0.70|0.110
71808036|NCT01972841|143118060|SUPERIORITY||Rate ratio|0.9|STANDARD_ERROR_OF_MEAN|0.1||0.288|TWO_SIDED|95.0|0.73|1.1|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.10|0.73|0.288
71808037|NCT01972841|143118060|SUPERIORITY||Rate ratio|0.65|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|0.53|0.79|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||0.79|0.53|<0.001
71808038|NCT01972841|143118060|SUPERIORITY||Rate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.1||0.084|TWO_SIDED|95.0|0.68|1.02|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.||1.02|0.68|0.084
71808039|NCT01972841|143118061|SUPERIORITY||Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.76||0.114|TWO_SIDED|95.0|-3.09|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.09|0.114
71843015|NCT03493542|143198414|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.39|||<|0.0001|TWO_SIDED|95.0|1.25|1.55|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 11||1.55|1.25|<0.0001
71843016|NCT03493542|143198414|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.53|||<|0.0001|TWO_SIDED|95.0|1.37|1.7|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 16||1.70|1.37|<0.0001
71843017|NCT03493542|143198414|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.66|||<|0.0001|TWO_SIDED|95.0|1.45|1.9|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 18||1.90|1.45|<0.0001
71843018|NCT03493542|143198435|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 6||1.2|-1.1|<0.0001
71843019|NCT03493542|143198435|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 11||1.2|-1.1|<0.0001
71843020|NCT03493542|143198435|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 16||1.2|-1.1|<0.0001
71843021|NCT03493542|143198435|NON_INFERIORITY|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|TWO_SIDED|95.0|-1.1|1.2|||Miettinen & Nurminen method|||Difference of Seroconversion percentage HPV 18||1.2|-1.1|<0.0001
71843022|NCT05485935|143198444|SUPERIORITY||Mean Difference (Final Values)|45.94||||0.001|TWO_SIDED|95.0|19.24|72.64||The pass criteria were based on results analysing the 2 primary endpoints in a hierarchical fashion: rejecting the H0 on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||72.64|19.24|0.001
71843023|NCT05485935|143198445|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.15|||<|0.001|TWO_SIDED|95.0|0.07|0.35|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.35|0.07|<0.001
71843024|NCT05485935|143198446|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Risk Ratio (RR)|0.13|||<|0.001|TWO_SIDED|95.0|0.04|0.4|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||0.40|0.04|<0.001
71843025|NCT05485935|143198447|SUPERIORITY|The pass criteria were based on the results analysing the two primary endpoints in a hierarchical fashion: rejecting the null hypothesis on the first endpoint (Residual urine at first flow-stop) before continuing to the second (Number of flow-stop episodes).|Mean Difference (Final Values)|28.5||||0.004|TWO_SIDED|95.0|9.5|47.6|||Mixed Models Analysis|||This was a superiority investigation in which the null hypothesis of the primary endpoints was to be rejected, at a 5% significance (alpha 0.05), to demonstrate the superiority of the investigational device.||47.6|9.5|0.004
71843026|NCT03839446|143198457|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.777|TWO_SIDED|95.0|0.18|3.65|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.65|0.18|0.777
71843027|NCT03839446|143198457|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.2|TWO_SIDED|95.0|0.96|1.01|||Regression, Cox|||Percent of blasts present in the bone marrow.||1.01|0.96|0.200
71843028|NCT03839446|143198457|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.014|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.014
71843029|NCT03839446|143198458|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.801|TWO_SIDED|95.0|0.17|3.86|||Regression, Cox||Intermediate / Favorable vs Poor|Cytogenetic status||3.86|0.17|0.801
71843030|NCT03839446|143198458|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.168|TWO_SIDED|95.0|0.95|1.01|||Regression, Cox|||% bone marrow blasts||1.01|0.95|0.168
71843031|NCT03839446|143198458|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.015|TWO_SIDED|95.0|0.94|0.99|||Regression, Cox|||% CD33 expression in leukemia blasts||0.99|0.94|0.015
71843032|NCT03952520|143198499|SUPERIORITY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|26.5|48.1|||||This generalized linear model was adjusted for engagement of site leadership. The Standard Approach is the referent.|||48.1|26.5|
71808040|NCT01972841|143118061|SUPERIORITY||Least squares mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.76||0.034|TWO_SIDED|95.0|-3.1|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.13|-3.10|0.034
71808041|NCT01972841|143118061|SUPERIORITY||Least squares mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-4.09|-1.12|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-1.12|-4.09|<0.001
71808042|NCT01972841|143118061|SUPERIORITY||Least squares mean difference|-2.21|STANDARD_ERROR_OF_MEAN|0.76||0.012|TWO_SIDED|95.0|-3.7|-0.71|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.71|-3.70|0.012
71808043|NCT01972841|143118062|SUPERIORITY||Least squares mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.134|TWO_SIDED|95.0|-0.46|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.46|0.134
71808044|NCT01972841|143118062|SUPERIORITY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.043|TWO_SIDED|95.0|-0.45|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.45|0.043
71808045|NCT01972841|143118062|SUPERIORITY||Least squares mean diffeence|-0.37|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.59|-0.15|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.15|-0.59|<0.001
71808046|NCT01972841|143118062|SUPERIORITY||Standard Error of the Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.11||0.019|TWO_SIDED|5.0|-0.54|-0.1|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.10|-0.54|0.019
71808047|NCT01972841|143118063|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.18||0.074|TWO_SIDED|95.0|-0.69|0.03|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.03|-0.69|0.074
71843033|NCT03952520|143198500|SUPERIORITY||Risk Difference (RD)|2.0|||||TWO_SIDED|95.0|2.0|2.1|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.1|2.0|
71843034|NCT03952520|143198502|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.2|0.4|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||0.4|-0.2|
71843035|NCT03952520|143198503|SUPERIORITY||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.1|2.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||2.0|-3.1|
71843036|NCT03952520|143198504|SUPERIORITY||Prevalence Difference|15.8|||||TWO_SIDED|95.0|5.0|26.5|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||26.5|5.0|
71843037|NCT03952520|143198505|SUPERIORITY||Prevalence Difference|1.6|||||TWO_SIDED|95.0|-6.9|10.0|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||10.0|-6.9|
71843038|NCT03952520|143198507|SUPERIORITY||Prevalence Difference|6.2|||||TWO_SIDED|95.0|-1.5|13.8|||||This generalized linear model was adjusted for engagement of site leadership and used generalized estimating equations to account for clustering by HIV test site. The Standard Approach is the referent.|||13.8|-1.5|
71843039|NCT03635567|143198509|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.47|0.71||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (hazard ratio \[HR\]) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.71|0.47|<0.0001
71676191|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.54|STANDARD_ERROR_OF_MEAN|1.44||0.71|TWO_SIDED|95.0|-3.35|2.28||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||2.28|-3.35|0.71
71676192|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|3.21|STANDARD_ERROR_OF_MEAN|1.34||0.02|TWO_SIDED|95.0|0.59|5.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||5.83|0.59|0.02
71676193|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|1.94||0.98|TWO_SIDED|95.0|-3.85|3.76||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||3.76|-3.85|0.98
71676194|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-2.13|STANDARD_ERROR_OF_MEAN|2.08||0.31|TWO_SIDED|95.0|-6.2|1.95||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.95|-6.2|0.31
71808048|NCT01972841|143118063|SUPERIORITY||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.014|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.09|-0.82|0.014
71808049|NCT01972841|143118063|SUPERIORITY||Least squares mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.01|-0.28|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.28|-1.01|<0.001
71843040|NCT03635567|143198510|OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.50|<0.0001
71843041|NCT03635567|143198511|OTHER||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.68||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.68|0.40|<0.0001
71894803|NCT04090164|143311581|OTHER||Odds Ratio (OR)|2.406||||0.0027|TWO_SIDED|95.0|1.341|4.316|||Fisher Exact|||Fisher exact test was used for testing of association of Breast Cancer diagnosis with anti-HCV test status.||4.316|1.341|0.0027
71894804|NCT04090164|143311581|OTHER||Odds Ratio (OR)|7.032||||0.0034|TWO_SIDED|95.0|1.582|31.25|||Fisher Exact|||Fisher exact test was used to test the association of Breast Cancer diagnosis with anti-HCV test result in women younger than 45 years.||31.25|1.582|0.0034
71894805|NCT01650805|143311583|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.074
71894806|NCT01650805|143311585|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||<0.001
71894807|NCT01650805|143311586|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score||||||0.317
71808050|NCT01972841|143118063|SUPERIORITY||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.24|0.51|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.51|-1.24|<0.001
71808051|NCT01972841|143118064|SUPERIORITY||Rate ratio|0.88|STANDARD_ERROR_OF_MEAN|0.05||0.006|TWO_SIDED|95.0|0.81|0.96|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.96|0.81|0.006
71808052|NCT01972841|143118064|SUPERIORITY||Rate ratio|0.81|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|0.74|0.88|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.88|0.74|<0.001
71808053|NCT01972841|143118064|SUPERIORITY||Rate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.05||0.049|TWO_SIDED|95.0|0.84|1.0|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.00|0.84|0.049
71808054|NCT01972841|143118064|SUPERIORITY||Rate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|0.79|0.94|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.94|0.79|0.001
71808055|NCT01972841|143118065|SUPERIORITY||Least squares mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.34||0.073|TWO_SIDED|95.0|-1.28|0.06|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.06|-1.28|0.073
71808056|NCT01972841|143118065|SUPERIORITY||Least squares mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.34||0.001|TWO_SIDED|95.0|-1.83|-0.48|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.48|-1.83|0.001
71808057|NCT01972841|143118065|SUPERIORITY||Least squares mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.34||0.14|TWO_SIDED|95.0|-1.18|0.17|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.17|-1.18|0.140
71808058|NCT01972841|143118065|SUPERIORITY||Least squares mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.88|-0.54|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.54|-1.88|<0.001
71808059|NCT01972841|143118066|SUPERIORITY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.065|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.065
71808060|NCT01972841|143118066|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
71808061|NCT01972841|143118066|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1|TWO_SIDED|95.0|-0.18|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.02|-0.18|0.100
71808062|NCT01972841|143118066|SUPERIORITY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.07|-0.26|0.001
71808063|NCT01972841|143118067|SUPERIORITY||Rate ratio|1.01|STANDARD_ERROR_OF_MEAN|0.12||0.938|TWO_SIDED|95.0|0.8|1.27|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.27|0.80|0.938
71808064|NCT01972841|143118067|SUPERIORITY||Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.12||0.967|TWO_SIDED|95.0|0.79|1.25|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.25|0.79|0.967
71808065|NCT01972841|143118067|SUPERIORITY||Standard Error of the Mean|0.73|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|95.0|0.58|0.92|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||0.92|0.58|0.008
71808066|NCT01972841|143118067|SUPERIORITY||Rate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.12||0.069|TWO_SIDED|95.0|0.64|1.02|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.||1.02|0.64|0.069
71808067|NCT01972841|143118068|SUPERIORITY||Least squares mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.86||0.958|TWO_SIDED|95.0|-1.73|1.64|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.64|-1.73|0.958
71677342|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.309|||||TWO_SIDED|95.0|0.206|0.463||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.463|0.206|
71808068|NCT01972841|143118068|SUPERIORITY||Least squares mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.86||0.5|TWO_SIDED|95.0|-2.27|1.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||1.11|-2.27|0.500
71808069|NCT01972841|143118068|SUPERIORITY||Least squares mean difference|-1.91|STANDARD_ERROR_OF_MEAN|0.87||0.028|TWO_SIDED|95.0|-3.62|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-3.62|0.028
71808070|NCT01972841|143118068|SUPERIORITY||Least squares mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.88||0.108|TWO_SIDED|95.0|-3.13|0.31|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.31|-3.13|0.108
71808071|NCT01972841|143118069|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.993|TWO_SIDED|95.0|-0.25|0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.25|-0.25|0.993
71843042|NCT03635567|143198512|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
71894808|NCT00770861|143311593|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|Between-treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors \& baseline value as a covariate.||H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.||||<0.0001
71808072|NCT01972841|143118069|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.65|TWO_SIDED|95.0|-0.3|0.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||0.19|-0.30|0.650
71894809|NCT00770861|143311594|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
71894810|NCT00630032|143311595|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.175|TWO_SIDED|95.0|0.59|1.1|||Log Rank|||||1.10|0.59|0.175
71894811|NCT00630032|143311596|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1687|TWO_SIDED|95.0|0.53|1.11|||Log Rank|||||1.11|0.53|0.1687
71894812|NCT00630032|143311597|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.6502|TWO_SIDED|95.0|0.45|1.63|||Log Rank|||||1.63|0.45|0.6502
71894813|NCT00630032|143311598|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0665|TWO_SIDED|95.0|0.49|1.02|||Log Rank|||||1.02|0.49|0.0665
71894814|NCT00630032|143311599|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.148|TWO_SIDED|95.0|0.59|1.08|||Log Rank|||||1.08|0.59|0.148
71894815|NCT00630032|143311600|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8968|TWO_SIDED|95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8968
71677343|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.8|||||TWO_SIDED|95.0|0.532|1.203||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||1.203|0.532|
71808073|NCT01972841|143118069|SUPERIORITY||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.13||0.035|TWO_SIDED|95.0|-0.52|-0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.02|-0.52|0.035
71808074|NCT01972841|143118069|SUPERIORITY||Least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.13||0.169|TWO_SIDED|95.0|-0.43|0.08|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate||0.08|-0.43|0.169
71808075|NCT01972841|143118070|SUPERIORITY||Odds Ratio (OR)|1.37||||0.003|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.003
71808076|NCT01972841|143118070|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.11|0.004
71808077|NCT01972841|143118070|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.29|1.95|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.29|<0.001
71894816|NCT02332915|143311601|SUPERIORITY|||||||0.0128|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for treated items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.0128
71894817|NCT02332915|143311602|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|dependent t-test||Null hypothesis is that there is no difference in mean effect size values for 2-week follow-up values for untreated (generalization) items for SPT-Intense and SPT-Traditional. The test was performed with a significance level of 0.05 (two-sided).||||.942
71894818|NCT02332915|143311603|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null Hypothesis: No difference in pre-treatment and post-treatment intelligibility scores||||<.001
71894819|NCT03063385|143311624|OTHER|\[Not specified\]|Slope|0.0153|STANDARD_ERROR_OF_MEAN|0.0067||0.0229|TWO_SIDED|95.0|0.0022|0.0285||Statistical significance taken at the 0.05 level|GEE modeling|P-value \& estimate rely on group x time interaction effect on primary outcome when controlling for self-efficacy. Used modified Baron \& Kenny method|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0285|0.0022|.0229
71894820|NCT03063385|143311624|OTHER|\[Not specified\]|Slope|0.0151|STANDARD_ERROR_OF_MEAN|0.0067||0.0249|TWO_SIDED|95.0|0.0019|0.0282||Statistical significance taken at the 0.05 level|GEE modeling|P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0282|0.0019|0.0249
71808078|NCT01972841|143118070|SUPERIORITY||Odds Ratio (OR)|1.36||||0.004|TWO_SIDED|95.0|1.1|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.||1.68|1.10|0.004
71896331|NCT03114969|143314793|SUPERIORITY||Odds Ratio (OR)|5.408||||0.042|TWO_SIDED|95.0|1.059|27.61||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||27.610|1.059|0.042
71808079|NCT01972841|143118071|SUPERIORITY||Odds Ratio (OR)|1.23||||0.039|TWO_SIDED|95.0|1.01|1.5|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.50|1.01|0.039
71808080|NCT01972841|143118071|SUPERIORITY||Odds Ratio (OR)|1.3||||0.009|TWO_SIDED|95.0|1.07|1.59|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.59|1.07|0.009
71808081|NCT01972841|143118071|SUPERIORITY||Odds Ratio (OR)|1.45|||<|0.001|TWO_SIDED|95.0|1.19|1.77|||overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.77|1.19|<0.001
71808082|NCT01972841|143118071|SUPERIORITY||Odds Ratio (OR)|1.5|||<|0.001|TWO_SIDED|95.0|1.23|1.84|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate||1.84|1.23|<0.001
71808083|NCT01972841|143118072|SUPERIORITY||Odds Ratio (OR)|1.32||||0.011|TWO_SIDED|95.0|1.07|1.64|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.64|1.07|0.011
71808084|NCT01972841|143118072|SUPERIORITY||Odds Ratio (OR)|1.41||||0.002|TWO_SIDED|95.0|1.14|1.75|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.75|1.14|0.002
71808085|NCT01972841|143118072|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.32|2.06|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.06|1.32|<0.001
71808086|NCT01972841|143118072|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.33|2.07|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.07|1.33|<0.001
71808087|NCT01972841|143118073|SUPERIORITY||Least squares mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.11|-0.41|<0.001
71808088|NCT01972841|143118073|SUPERIORITY||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.54|-0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.25|-0.54|<0.001
71808089|NCT01972841|143118073|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
71808090|NCT01972841|143118073|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.50|<0.001
71808091|NCT01972841|143118075|SUPERIORITY||Least squares mean difference|3.81|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|1.69|5.94|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.94|1.69|<0.001
71808092|NCT01972841|143118075|SUPERIORITY||Least squares mean difference|4.16|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.03|6.29|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.29|2.03|<0.001
71808093|NCT01972841|143118075|SUPERIORITY||Least squares mean difference|5.02|STANDARD_ERROR_OF_MEAN|1.09|<|0.001|TWO_SIDED|95.0|2.88|7.15|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.15|2.88|<0.001
71808094|NCT01972841|143118075|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.09||0.002|TWO_SIDED|95.0|1.17|5.43|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.43|1.17|0.002
71808095|NCT01972841|143118076|SUPERIORITY||Least squares mean difference|4.12|STANDARD_ERROR_OF_MEAN|1.29||0.001|TWO_SIDED|95.0|1.6|6.65|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.65|1.60|0.001
71808096|NCT01972841|143118076|SUPERIORITY||Lest squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|2.34|7.4|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.40|2.34|<0.001
71808097|NCT01972841|143118076|SUPERIORITY||Least squares mean difference|6.09|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|3.55|8.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||8.63|3.55|<0.001
71808098|NCT01972841|143118076|SUPERIORITY||Least squares mean difference|3.8|STANDARD_ERROR_OF_MEAN|1.29||0.003|TWO_SIDED|95.0|1.27|6.33|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.33|1.27|0.003
71808099|NCT01972841|143118077|SUPERIORITY||Least squares mean difference|4.24|STANDARD_ERROR_OF_MEAN|1.22||0.001|TWO_SIDED|95.0|1.84|6.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.63|1.84|0.001
71808100|NCT01972841|143118077|SUPERIORITY||Least squares mean difference|4.82|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.42|7.22|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.22|2.42|<0.001
71843043|NCT03635567|143198513|OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.77||No formal hypothesis testing performed; nominal p-value based on log-rank test provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.77|0.52|<0.0001
71843044|NCT03635567|143198514|OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.44|0.78||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.78|0.44|<0.0001
71808101|NCT01972841|143118077|SUPERIORITY||Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|1.23|<|0.001|TWO_SIDED|95.0|2.93|7.75|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.75|2.93|<0.001
71808102|NCT01972841|143118077|SUPERIORITY||Least squares mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|2.01|6.81|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.81|2.01|<0.001
71808103|NCT01972841|143118078|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.85|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.85|1.98|<0.001
71808104|NCT01972841|143118078|SUPERIORITY||Least squares mean difference|4.42|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|TWO_SIDED|95.0|1.98|6.86|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||6.86|1.98|<0.001
71808105|NCT01972841|143118078|SUPERIORITY||Least squares mean difference|4.87|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|2.42|7.32|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||7.32|2.42|<0.001
71808106|NCT01972841|143118078|SUPERIORITY||Least squares mean difference|3.28|STANDARD_ERROR_OF_MEAN|1.24||0.008|TWO_SIDED|95.0|0.84|5.72|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||5.72|0.84|0.008
71808107|NCT01972841|143118079|SUPERIORITY||Least squares mean difference|2.27|STANDARD_ERROR_OF_MEAN|0.99||0.022|TWO_SIDED|95.0|0.33|4.21|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.21|0.33|0.022
71808108|NCT01972841|143118079|SUPERIORITY||Least squares mean difference|2.25|STANDARD_ERROR_OF_MEAN|0.99||0.023|TWO_SIDED|95.0|0.31|4.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.19|0.31|0.023
71808109|NCT01972841|143118079|SUPERIORITY||Least squares mean difference|2.8|STANDARD_ERROR_OF_MEAN|0.99||0.005|TWO_SIDED|95.0|0.85|4.74|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||4.74|0.85|0.005
71808110|NCT01972841|143118079|SUPERIORITY||Least squares mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.99||0.337|TWO_SIDED|95.0|-0.99|2.89|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.||2.89|-0.99|0.337
71808111|NCT01972841|143118092|SUPERIORITY||Odds Ratio (OR)|1.31||||0.035|TWO_SIDED|95.0|1.02|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.69|1.02|0.035
71808112|NCT01972841|143118092|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.81|1.09|0.009
71808113|NCT01972841|143118092|SUPERIORITY||Odds Ratio (OR)|1.5||||0.002|TWO_SIDED|95.0|1.16|1.93|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.93|1.16|0.002
71843045|NCT03635567|143198515|OTHER||Difference in Percentage|14.9||||0.0001|TWO_SIDED|95.0|7.4|22.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Miettinen & Nurminen method|||Treatment comparison was based on Miettinen \& Nurminen method stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||22.3|7.4|0.0001
71894821|NCT03063385|143311624|OTHER|\[Not specified\]|Slope|0.0158|STANDARD_ERROR_OF_MEAN|0.0068||0.0204|TWO_SIDED|95.0|0.0025|0.0292||Statistical significance taken at the 0.05 level|GEE modeling|Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B\&K|\[Not specified\]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.||0.0292|0.0025|0.0204
71894822|NCT03440112|143311670|SUPERIORITY||Chi-Squared|3.0039||||0.391|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.391
71894823|NCT03440112|143311671|SUPERIORITY||Chi-Squared|9.4836||||0.02351|TWO_SIDED||||||Mixed Models Analysis|||A pair of random-intercept mixed linear models was fitted, a visit model and an interaction model. Visit model included fixed effect of visit and a random intercept by participant. Interaction model adds an interaction by treatment term on top of the visit model. Null hypothesis is that visit by treatment interaction does not explain significant additional variance in clinical outcome scores. Likelihood ratio test comparing the interaction model to the visit model was used to derive a p-value.||||0.02351
71894824|NCT02413255|143311680|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0195||||0.465|TWO_SIDED|90.0|0.9752|1.0637|||Power Model|||||1.0637|0.9752|0.465
71894825|NCT02413255|143311681|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.1124||||0.126|TWO_SIDED|90.0|0.9913|1.2336|||Power Model|||Day 1||1.2336|0.9913|0.126
71894826|NCT02413255|143311681|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.09||||0.114|TWO_SIDED|90.0|0.9962|1.1838|||Power Model|||Day 9||1.1838|0.9962|0.114
71894827|NCT02413255|143311682|SUPERIORITY|||||||0.5402|||||||ANOVA|Statistical analysis results were obtained using Analysis of Variance (ANOVA) with dose level as a fixed effect.||||||0.5402
71894828|NCT02413255|143311683|SUPERIORITY|||||||0.7824|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 1||||0.7824
71894829|NCT02413255|143311683|SUPERIORITY|||||||0.4056|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 9||||0.4056
71894830|NCT02413255|143311684|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0606||||0.019|TWO_SIDED|90.0|1.0187|1.1026|||Power Model|||||1.1026|1.0187|0.019
71808114|NCT01972841|143118092|SUPERIORITY||Odds Ratio (OR)|1.34||||0.023|TWO_SIDED|95.0|1.04|1.73|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.73|1.04|0.023
71808115|NCT01972841|143118093|SUPERIORITY||Odds Ratio (OR)|1.22||||0.224|TWO_SIDED|95.0|0.88|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.69|0.88|0.224
71843046|NCT03635567|143198518|OTHER||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|95.0|0.49|0.74||No formal hypothesis testing performed; nominal p-value provided for treatment comparison|Stratified Log-Rank|Nominal p-value based on log-rank test stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB), bevacizumab use, and PD-L1 status.||Treatment comparison (HR) was based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastatic at initial diagnosis (FIGO \[2009\] stage IVB) (yes or no), bevacizumab use (yes or no), and PD-L1 status (CPS\<1, CPS 1 to \<10, or CPS ≥10).||0.74|0.49|<0.0001
71843047|NCT05157841|143198524|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Mean Difference (Final Values)|-164.0|STANDARD_ERROR_OF_MEAN|27.74|<|1e-05|TWO_SIDED|95.0|-218.3|-109.6|||ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||-109.6|-218.3|<0.00001
71894831|NCT02413255|143311685|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0789||||0.258|TWO_SIDED|90.0|0.9628|1.195|||Power Model|||Day 1||1.1950|0.9628|0.258
71894832|NCT02413255|143311685|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0929||||0.144|TWO_SIDED|90.0|0.9878|1.198|||Power Model|||Day 9||1.1980|0.9878|0.144
71894833|NCT02413255|143311688|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0799||||0.003|TWO_SIDED|90.0|1.0371|1.1227|||Power Model|||||1.1227|1.0371|0.003
71894834|NCT02413255|143311689|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0897||||0.201|TWO_SIDED|90.0|0.9735|1.206|||Power Model|||||1.2060|0.9735|0.201
71894835|NCT02413255|143311690|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0188||||0.49|TWO_SIDED|90.0|0.9734|1.0642|||Power Model|||||1.0642|0.9734|0.490
71677344|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.662|||||TWO_SIDED|95.0|0.442|0.992||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.992|0.442|
71808116|NCT01972841|143118093|SUPERIORITY||Odds Ratio (OR)|1.42||||0.037|TWO_SIDED|95.0|1.02|1.96|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.96|1.02|0.037
71808117|NCT01972841|143118093|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.001|TWO_SIDED|95.0|1.47|2.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.67|1.47|<0.001
71808118|NCT01972841|143118093|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.26|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.26|1.21|0.002
71808119|NCT01972841|143118094|SUPERIORITY||Odds Ratio (OR)|1.29||||0.077|TWO_SIDED|95.0|0.97|1.72|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.72|0.97|0.077
71808120|NCT01972841|143118094|SUPERIORITY||Odds Ratio (OR)|1.15||||0.321|TWO_SIDED|95.0|0.87|1.53|||Logistic regression|||Odds ratio from a logistic regression model treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.87|0.321
71808121|NCT01972841|143118094|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.001|TWO_SIDED|95.0|1.46|2.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||2.53|1.46|<0.001
71808122|NCT01972841|143118094|SUPERIORITY||Odds Ratio (OR)|1.16||||0.294|TWO_SIDED|95.0|0.88|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.||1.53|0.88|0.294
71808123|NCT01972841|143118095|SUPERIORITY||Odds Ratio (OR)|1.17||||0.251|TWO_SIDED|95.0|0.89|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.53|0.89|0.251
71808124|NCT01972841|143118095|SUPERIORITY||Odds Ratio (OR)|1.25||||0.107|TWO_SIDED|95.0|0.95|1.64|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.64|0.95|0.107
71808125|NCT01972841|143118095|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.07|1.23|<0.001
71808126|NCT01972841|143118095|SUPERIORITY||Odds Ratio (OR)|1.41||||0.012|TWO_SIDED|95.0|1.08|1.85|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.85|1.08|0.012
71808127|NCT01972841|143118096|SUPERIORITY||Odds Ratio (OR)|1.3||||0.044|TWO_SIDED|95.0|1.01|1.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.67|1.01|0.044
71808128|NCT01972841|143118096|SUPERIORITY||Odds Ratio (OR)|1.43||||0.006|TWO_SIDED|95.0|1.11|1.84|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.84|1.11|0.006
71843048|NCT05157841|143198525|SUPERIORITY|A one-sided hypothesis test was performed at alpha=0.025 level of significance comparing EXPAREL and bupivacaine HCI|Least square mean difference|0.39|||<|1e-05|TWO_SIDED|95.0|0.28|0.55|||ANCOVA|||The superiority of EXPAREL to bupivacaine hydrochloric acid (HCI) was evaluated using the Efficacy Analysis Set.||0.55|0.28|<0.00001
71843049|NCT05157841|143198526|SUPERIORITY||Odds Ratio (OR)|5.04||||0.0003|TWO_SIDED|95.0|2.01|12.62|||ANCOVA|||||12.62|2.01|0.0003
71843050|NCT05157841|143198527|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0089|TWO_SIDED|95.0|0.45|0.93|||Cox proportional hazards model|Cox proportional hazards model with treatment as main effect and site as categorical and age as continuous covariates.||||0.93|0.45|0.0089
71843051|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.44||0.0296|TWO_SIDED|95.0|-1.7|0.0||Worst pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariate of age.||||0.0|-1.7|0.0296
71843052|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|1e-05|TWO_SIDED|95.0|-3.6|-2.1||Worst pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.1|-3.6|<0.00001
71843053|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.41|<|1e-05|TWO_SIDED|95.0|-4.1|-2.5||Worst pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-2.5|-4.1|<0.00001
71808129|NCT01972841|143118096|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.9|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.90|1.13|0.004
71808130|NCT01972841|143118096|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.23|2.08|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.08|1.23|<0.001
71808131|NCT01972841|143118097|SUPERIORITY||Odds Ratio (OR)|1.47||||0.004|TWO_SIDED|95.0|1.13|1.92|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.92|1.13|0.004
71808132|NCT01972841|143118097|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.24|2.11|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.11|1.24|<0.001
71808133|NCT01972841|143118097|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.22|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.07|1.22|0.001
71808134|NCT01972841|143118097|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.04|1.21|0.001
71808135|NCT01972841|143118098|SUPERIORITY||Odds Ratio (OR)|1.32||||0.065|TWO_SIDED|95.0|0.98|1.78|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.78|0.98|0.065
71808136|NCT01972841|143118098|SUPERIORITY||Odds Ratio (OR)|1.68||||0.001|TWO_SIDED|95.0|1.24|2.27|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.27|1.24|0.001
71808137|NCT01972841|143118098|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.32|2.36|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.36|1.32|<0.001
71676195|NCT04075682|142870119|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.93||0.68|TWO_SIDED|95.0|-4.58|2.97||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.97|-4.58|0.68
71808138|NCT01972841|143118098|SUPERIORITY||Odds Ratio (OR)|1.51||||0.007|TWO_SIDED|95.0|1.12|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.04|1.12|0.007
71808139|NCT01972841|143118099|SUPERIORITY||Odds Ratio (OR)|1.44||||0.007|TWO_SIDED|95.0|1.11|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||1.87|1.11|0.007
71808140|NCT01972841|143118099|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.17|1.28|<0.001
71808141|NCT01972841|143118099|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.34|2.3|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.30|1.34|<0.001
71808142|NCT01972841|143118099|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.29|2.19|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.||2.19|1.29|<0.001
71843054|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|1e-05|TWO_SIDED|95.0|-3.0|-1.3||Worst pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-3.0|<0.00001
71843055|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.36||0.3419|TWO_SIDED|95.0|-0.9|0.6||Average pain 0-24 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||0.6|-0.9|0.3419
71843056|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.5|-1.3||Average pain 24-48 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.3|-2.5|<0.00001
71843057|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.8|-1.6||Average pain 48-72 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-1.6|-2.8|<0.00001
71843058|NCT05157841|143198528|SUPERIORITY||Least square mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|1e-05|TWO_SIDED|95.0|-2.1|-0.9||Average pain 72-96 hours|ANCOVA|Main effect of treatment, categorical covariate of pooled Investigator site, and continuous covariates of age||||-0.9|-2.1|<0.00001
71843059|NCT04933474|143198536|OTHER|||||||0.088|||||||Chi-squared|||The primary outcome will be the baseline vs. week 8 difference-in-difference in 7-day average NRS pain intensity scores, dichotomized into if the MCID of 2 is achieved. The between arm difference of achieving the MCID of 2 will be tested using Chi-squared test.||||0.088
71843060|NCT04933474|143198537|OTHER|||||||0.103|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.103
71843061|NCT04933474|143198538|OTHER|||||||0.774|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.774
71808143|NCT01972841|143118100|SUPERIORITY||Odds Ratio (OR)|1.12||||0.381|TWO_SIDED|95.0|0.87|1.45|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.45|0.87|0.381
71808144|NCT01972841|143118100|SUPERIORITY||Odds Ratio (OR)|1.31||||0.04|TWO_SIDED|95.0|1.01|1.7|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||1.70|1.01|0.040
71808145|NCT01972841|143118100|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.0|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.00|1.21|0.001
71808146|NCT01972841|143118100|SUPERIORITY||Odds Ratio (OR)|1.57||||0.001|TWO_SIDED|95.0|1.21|2.03|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.03|1.21|0.001
71808147|NCT01972841|143118101|SUPERIORITY||Odds Ratio (OR)|1.24||||0.095|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.59|0.96|0.095
71808148|NCT01972841|143118101|SUPERIORITY||Odds Ratio (OR)|1.26||||0.073|TWO_SIDED|95.0|0.98|1.62|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.62|0.98|0.073
71808149|NCT01972841|143118101|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.29|2.13|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.13|1.29|<0.001
71808150|NCT01972841|143118101|SUPERIORITY||Odds Ratio (OR)|1.27||||0.067|TWO_SIDED|95.0|0.98|1.63|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||1.63|0.98|0.067
71808151|NCT01972841|143118102|SUPERIORITY||Odds Ratio (OR)|1.18||||0.21|TWO_SIDED|95.0|0.91|1.52|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.52|0.91|0.210
71808152|NCT01972841|143118102|SUPERIORITY||Odds Ratio (OR)|1.46||||0.004|TWO_SIDED|95.0|1.13|1.89|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||1.89|1.13|0.004
71808153|NCT01972841|143118102|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.06|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.06|1.23|<0.001
71808154|NCT01972841|143118102|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.001|TWO_SIDED|95.0|1.23|2.05|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.||2.05|1.23|<0.001
71808155|NCT01972841|143118103|SUPERIORITY||Odds Ratio (OR)|1.13||||0.335|TWO_SIDED|95.0|0.88|1.46|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.46|0.88|0.335
71843062|NCT04933474|143198539|OTHER|||||||0.005|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.005
71843063|NCT04933474|143198540|OTHER|||||||0.831|||||||t-test, 2 sided|||A two-sample t-test will be used to compare differences-in-differences between the arms.||||0.831
71843064|NCT04933474|143198541|OTHER||Common Odds Ratio|1.44||||0.031|TWO_SIDED|95.0|1.03|2.02||A two-sided test performed at the 0.05 level of significance without the continuity correction.|Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test was used to compare the association between time (baseline and week 8) and opioid use (yes or no) while stratifying for the treatment groups. The null hypothesis is that the common odds ratio of the association between time and response across the treatment groups is equal to 1, versus the alternative hypothesis that the common odds ratio is not equal to 1.||2.02|1.03|0.031
71677345|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.714|||||TWO_SIDED|95.0|1.142|2.572||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.572|1.142|
71808156|NCT01972841|143118103|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||1.81|1.09|0.009
71808157|NCT01972841|143118103|SUPERIORITY||Odds Ratio (OR)|1.56||||0.001|TWO_SIDED|95.0|1.21|2.02|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.02|1.21|0.001
71808158|NCT01972841|143118103|SUPERIORITY||Odds Ratio (OR)|1.71|||<|0.001|TWO_SIDED|95.0|1.33|2.21|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.21|1.33|<0.001
71808159|NCT01972841|143118104|SUPERIORITY||Odds Ratio (OR)|1.11||||0.416|TWO_SIDED|95.0|0.86|1.43|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.43|0.86|0.416
71808160|NCT01972841|143118104|SUPERIORITY||Odds Ratio (OR)|1.23||||0.105|TWO_SIDED|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.59|0.96|0.105
71808161|NCT01972841|143118104|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.001|TWO_SIDED|95.0|1.28|2.16|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.16|1.28|<0.001
71808162|NCT01972841|143118104|SUPERIORITY||Odds Ratio (OR)|1.45||||0.005|TWO_SIDED|95.0|1.12|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.87|1.12|0.005
71808163|NCT03712891|143118119|OTHER|t-test||||||0.12|||||||t-test, 2 sided|||||||0.12
71808164|NCT01181050|143118191|SUPERIORITY_OR_OTHER||Treatment difference|-0.02||||0.9334||95.0|-0.54|0.5|||Mixed effect model repeated measures|||||0.50|-0.54|0.9334
71808165|NCT01181050|143118192|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.8293||95.0|-0.46|0.58|||Mixed effect model repeated measures|||||0.58|-0.46|0.8293
71808166|NCT01181050|143118193|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8867||95.0|-0.65|0.56|||Mixed effect model repeated measures|||||0.56|-0.65|0.8867
71808167|NCT01018394|143118194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.108|TWO_SIDED|95.0|0.7|5.1||A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|Fisher Exact|1 tailed||The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.||5.1|0.7|0.108
71808168|NCT00683644|143118196|OTHER|The observed power in THQ for zinc is 0.16, and that for placebo is 0.06.|||||>|0.05||||||Threshold for significance is 0.05|Chi-squared|||||||>0.05
71808169|NCT00683644|143118197|OTHER|||||||0.89||||||Threshold for significance is 0.05|paired t test|||||||0.89
71808170|NCT00683644|143118197|OTHER|||||||0.36||||||Threshold for significance is 0.05|paired t test|||||||0.36
71843065|NCT01527188|143198705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-198.18||||0.0427|TWO_SIDED|95.0|-389.82|-6.55|||ANCOVA|||||-6.55|-389.82|0.0427
71843066|NCT01527188|143198705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-171.82||||0.0793||95.0|-363.87|20.24|||ANCOVA|||||20.24|-363.87|0.0793
71843067|NCT01527188|143198705|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-118.43|||||TWO_SIDED|95.0|-305.9|69.04|||ANCOVA|||The statistical test is not applicable due to the step-down approach performed to address the multiplicity issue.||69.04|-305.90|
71808171|NCT00683644|143118198|OTHER|||||||0.64||||||Threshold for significance is 0.05|paired t test|||||||0.64
71808172|NCT00683644|143118198|OTHER|||||||0.93||||||Threshold for significance is 0.05|paired t test|||||||0.93
71808173|NCT01565707|143118199|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|12.1|STANDARD_ERROR_OF_MEAN|6.0||0.046|TWO_SIDED|95.0|0.2|24.0|||ANCOVA|From an ANCOVA (analysis of covariance) model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||"The following hypotheses were tested at the 2-sided significance level 0.05:~* H0: Change from baseline to EoT in mean MVV per micturition is the same for placebo and solifenacin succinate oral suspension~* H1: Change from baseline to EoT in mean MVV per micturition is not the same for placebo and solifenacin succinate oral suspension"||24.0|0.2|0.046
71808174|NCT01565707|143118199|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|15.7|||TWO_SIDED|95.0|-36.7|27.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||27.4|-36.7|
71808175|NCT01565707|143118200|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|31.9|STANDARD_ERROR_OF_MEAN|13.9||0.024|TWO_SIDED|95.0|4.3|59.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||59.5|4.3|0.024
71808176|NCT01565707|143118200|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-17.3|STANDARD_ERROR_OF_MEAN|29.1|||TWO_SIDED|95.0|-76.5|41.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||41.9|-76.5|
71808177|NCT01565707|143118201|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.763|TWO_SIDED|95.0|-0.3|0.4||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.4|-0.3|0.763
71808178|NCT01565707|143118201|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.8|1.0|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.0|-0.8|
71808179|NCT01565707|143118202|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.402|TWO_SIDED|95.0|-0.5|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.5|0.402
71808180|NCT01565707|143118202|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.5|0.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.4|-1.5|
71808181|NCT01565707|143118203|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.63|TWO_SIDED|95.0|0.0|0.2||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.2|0.0|0.630
71808182|NCT01565707|143118203|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.2|0.2|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate..|||0.2|-0.2|
71808183|NCT01565707|143118204|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.563|TWO_SIDED|95.0|-1.0|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-1.0|0.563
71808184|NCT01565707|143118204|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.6|1.9|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.9|-1.6|
71808185|NCT01565707|143118205|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.77|TWO_SIDED|95.0|-0.9|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.3|-0.9|0.770
71808186|NCT01565707|143118205|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.4|1.3|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.3|-0.4|
71808187|NCT01565707|143118206|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.303|TWO_SIDED|95.0|-0.8|0.2||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|ANCOVA|||||0.2|-0.8|0.303
71808188|NCT01565707|143118206|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.9|1.1|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.1|-0.9|
71808189|NCT01565707|143118207|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.64|TWO_SIDED|95.0|-0.8|0.5|||ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.5|-0.8|0.640
71808190|NCT01565707|143118207|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.9|1.4|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||1.4|-0.9|
71808191|NCT01565707|143118208|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.846|TWO_SIDED|95.0|-0.3|0.1||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.||||0.1|-0.3|0.846
71808192|NCT01565707|143118208|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.0|0.5|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.5|-1.0|
71843068|NCT01527188|143198706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-125.61||||0.0323||95.0|-240.53|-10.69|||ANCOVA|||||-10.69|-240.53|0.0323
71843069|NCT01527188|143198706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-122.23||||0.0376||95.0|-237.38|-7.08|||ANCOVA|||||-7.08|-237.38|0.0376
71843070|NCT01527188|143198706|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-91.18||||0.1119||95.0|-203.74|21.38|||ANCOVA|||||21.38|-203.74|0.1119
71843071|NCT03512301|143198738|OTHER||Accuracy|0.6587|||||TWO_SIDED|95.0|0.569|0.7408||||||||0.7408|0.5690|
71843072|NCT03512301|143198738|OTHER||Sensitivity|0.8736|||||TWO_SIDED|||||||||||||
71843073|NCT03512301|143198738|OTHER||Specificity|0.4872|||||TWO_SIDED|||||||||||||
71843074|NCT03512301|143198738|OTHER||Positive Predictive Value|0.7917|||||TWO_SIDED|||||||||||||
71843075|NCT03512301|143198738|OTHER||Negative Predictive Value|0.6333|||||TWO_SIDED|||||||||||||
71843076|NCT03512301|143198738|OTHER||Sensitivity|0.1212|||||TWO_SIDED|||||||||||||
71843077|NCT03512301|143198738|OTHER||Specificity|0.9032|||||TWO_SIDED|||||||||||||
71894836|NCT02413255|143311691|EQUIVALENCE|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0846||||0.224|TWO_SIDED|90.0|0.969|1.2002|||Power Model|||||1.2002|0.9690|0.224
71894837|NCT02413255|143311698|SUPERIORITY||||||<|0.0001|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||||||<.0001
71894838|NCT02413255|143311714|OTHER||Estimated Ratio|1.121|||||TWO_SIDED|90.0|0.772|1.628||||||||1.628|0.772|
71894839|NCT02413255|143311714|OTHER||Estimated Ratio|1.156|||||TWO_SIDED|90.0|0.796|1.678||||||||1.678|0.796|
71894840|NCT02413255|143311714|OTHER||Estimated Ratio|0.982|||||TWO_SIDED|90.0|0.676|1.425||||||||1.425|0.676|
71894841|NCT02413255|143311714|OTHER||Estimated Ratio|1.055|||||TWO_SIDED|90.0|0.701|1.587||||||||1.587|0.701|
71677346|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|Geometric mean ratio at day 22|2.589|||||TWO_SIDED|95.0|1.723|3.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.889|1.723|
71808193|NCT01565707|143118209|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-1.4|0.8|||||From an ANCOVA model including treatment, geographic region \& gender as fixed effects \& the baseline value as a covariate.|||0.8|-1.4|
71808194|NCT00866840|143118234|OTHER|||||||||||||||||No objective responses were seen in the first phase and accrual was stopped.|No objective responses were seen in the first phase and accrual was stopped.|||
71808195|NCT02625623|143118237|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8078|TWO_SIDED|95.0|0.88|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.41|0.88|0.8078
71808196|NCT02625623|143118238|SUPERIORITY||Hazard Ratio (HR)|1.73||||1|TWO_SIDED|95.0|1.36|2.21|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||2.21|1.36|1.0000
71843078|NCT03512301|143198738|OTHER||Positive Predictive Value|0.3077|||||TWO_SIDED|||||||||||||
71843079|NCT03512301|143198738|OTHER||Negative Predictive Value|0.7434|||||TWO_SIDED|||||||||||||
71843080|NCT03512301|143198738|OTHER||Sensitivity|0.5|||||TWO_SIDED|||||||||||||
71808197|NCT02625623|143118240|SUPERIORITY||Odds Ratio (OR)|0.709||||0.8764|||||||Cochran-Mantel-Haenszel|The treatment arms were compared by 1-sided CMH test. The stratification factor was region (Asia versus non Asia).||||||0.8764
71843081|NCT03512301|143198738|OTHER||Specificity|0.8833|||||TWO_SIDED|||||||||||||
71843082|NCT03512301|143198738|OTHER||Positive Predictive Value|0.1765|||||TWO_SIDED|||||||||||||
71843083|NCT03512301|143198738|OTHER||Negative Predictive Value|0.9725|||||TWO_SIDED|||||||||||||
71843084|NCT03512301|143198738|OTHER||Quadratic Weighted Kappa|0.4446|||||TWO_SIDED|95.0|0.2791|0.6101||||||||0.6101|0.2791|
71843085|NCT03512301|143198739|OTHER|Linear Regression. Power calculations for linear regression between CAMCI and MoCA were found to be sufficiently powered with a Pearson's R of at least 0.3 at 80% power and that equated to a test-set size of 98.|Pearson Correlation|0.5073|||||TWO_SIDED|95.0|0.3892|0.6091|||||Linear Regression Equation: \[CAMCI Score\] = -5.42 + 1.40 X \[MoCA Score\]|||0.6091|0.3892|
71843086|NCT03512301|143198739|OTHER||Accuracy|0.5556|||||TWO_SIDED|95.0|0.4644|0.644||||||||0.6440|0.4644|
71843087|NCT03512301|143198739|OTHER||Sensitivity|0.9747|||||TWO_SIDED|||||||||||||
71894842|NCT02413255|143311714|OTHER||Estimated Ratio|1.105|||||TWO_SIDED|90.0|0.761|1.604||||||||1.604|0.761|
71894843|NCT02413255|143311714|OTHER||Estimated Ratio|1.225|||||TWO_SIDED|90.0|0.844|1.778||||||||1.778|0.844|
71894844|NCT02333331|143311715|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.274|TWO_SIDED|95.0|-0.64|1.21|||Mixed Models Analysis|||||1.21|-0.64|0.274
71894845|NCT02333331|143311715|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.32|TWO_SIDED|95.0|-0.83|1.35|||Mixed Models Analysis|||||1.35|-0.83|0.320
71894846|NCT02333331|143311715|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.134|TWO_SIDED|95.0|-0.24|0.87|||Mixed Models Analysis|||||0.87|-0.24|0.134
71894847|NCT02333331|143311716|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.576|TWO_SIDED|95.0|-37.6|30.95|||Mixed Models Analysis|||||30.95|-37.6|0.576
71894848|NCT02333331|143311716|SUPERIORITY||Mean Difference (Final Values)|19.6||||0.178|TWO_SIDED|95.0|-22.2|61.41|||Mixed Models Analysis|||||61.41|-22.2|0.178
71894849|NCT02333331|143311716|SUPERIORITY||Mean Difference (Final Values)|10.31||||0.163|TWO_SIDED|95.0|-10.4|30.98|||Mixed Models Analysis|||||30.98|-10.4|0.163
71843088|NCT03512301|143198739|OTHER||Specificity|0.3913|||||TWO_SIDED|||||||||||||
71843089|NCT03512301|143198739|OTHER||Positive Predictive Value|0.5625|||||TWO_SIDED|||||||||||||
71843090|NCT03512301|143198739|OTHER||Negative Predictive Value|0.9|||||TWO_SIDED|||||||||||||
71843091|NCT03512301|143198739|OTHER||Sensitivity|0.1905|||||TWO_SIDED|||||||||||||
71843092|NCT03512301|143198739|OTHER||Specificity|0.9841|||||TWO_SIDED|||||||||||||
71843093|NCT03512301|143198739|OTHER||Positive Predictive Value|0.9231|||||TWO_SIDED|||||||||||||
71843094|NCT03512301|143198739|OTHER||Negative Predictive Value|0.5487|||||TWO_SIDED|||||||||||||
71843095|NCT03512301|143198739|OTHER||Sensitivity|0.6667|||||TWO_SIDED|||||||||||||
71843096|NCT03512301|143198739|OTHER||Specificity|0.8917|||||TWO_SIDED|||||||||||||
71843097|NCT03512301|143198739|OTHER||Positive Predictive Value|0.2353|||||TWO_SIDED|||||||||||||
71843098|NCT03512301|143198739|OTHER||Negative Predictive Value|0.9817|||||TWO_SIDED|||||||||||||
71843099|NCT03512301|143198739|OTHER||Quadratic Weighted Kappa|0.3931|||||TWO_SIDED|95.0|0.2401|0.5461||||||||0.5461|0.2401|
71894850|NCT02333331|143311717|SUPERIORITY||Mean Difference (Net)|0.0||||0.488|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.10|-0.10|0.488
71894851|NCT02333331|143311717|SUPERIORITY||Mean Difference (Net)|0.1||||0.055|TWO_SIDED|95.0|-0.02|0.22|||Mixed Models Analysis|||||0.22|-0.02|0.055
71894852|NCT02333331|143311717|SUPERIORITY||Mean Difference (Net)|0.03||||0.161|TWO_SIDED|95.0|-0.03|0.09|||Mixed Models Analysis|||||0.09|-0.03|0.161
71894853|NCT02333331|143311718|SUPERIORITY||Mean Difference (Net)|1.01||||0.213|TWO_SIDED|95.0|0.99|1.03|||Mixed Models Analysis|||||1.03|0.99|0.213
71894854|NCT02333331|143311718|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.09|||Mixed Models Analysis|||||1.09|1.03|<0.001
71894855|NCT02333331|143311718|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.05|1.08|||Mixed Models Analysis|||||1.08|1.05|<0.001
71808198|NCT02352948|143118245|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.42|0.93|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||0.93|0.42|
71808199|NCT02352948|143118245|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.109|TWO_SIDED|95.0|0.61|1.05|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.05|0.61|0.109
71808200|NCT02352948|143118246|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||1.04|0.49|
71808201|NCT02352948|143118246|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.056|TWO_SIDED|95.0|0.59|1.01|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||1.01|0.59|0.056
71808202|NCT02352948|143118247|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.74|1.3|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.30|0.74|0.885
71808203|NCT02352948|143118247|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.153|TWO_SIDED|95.0|0.56|1.11|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||1.11|0.56|0.153
71808204|NCT02352948|143118248|SUPERIORITY|||||||0.063||||||The z-test statistic is the ratio of log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by square root of the variance.|z-test|The variance is estimated using the delta method and Greenwood's formula.||For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||||0.063
71808205|NCT02352948|143118249|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.282|TWO_SIDED|95.0|0.68|1.12|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.12|0.68|0.282
71843100|NCT04174170|143198763|SUPERIORITY||Treatment Difference|1.03||||0.5165|TWO_SIDED|95.0|-2.09|4.16|||MMRM|||||4.16|-2.09|0.5165
71843101|NCT04174170|143198763|SUPERIORITY||Treatment Difference|-0.71||||0.6593|TWO_SIDED|95.0|-3.88|2.46|||MMRM|||||2.46|-3.88|0.6593
71843102|NCT04174170|143198764|SUPERIORITY||Treatment Difference|0.03||||0.8215|TWO_SIDED|95.0|-0.25|0.31||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.31|-0.25|0.8215
71843103|NCT04174170|143198764|SUPERIORITY||Treatment Difference|-0.03||||0.8584|TWO_SIDED|95.0|-0.31|0.26||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||0.26|-0.31|0.8584
71843104|NCT04174170|143198765|SUPERIORITY||Treatment Difference|-4.16||||0.2331|TWO_SIDED|95.0|-11.0|2.69||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||2.69|-11.00|0.2331
71894856|NCT02333331|143311719|SUPERIORITY||Mean Difference (Net)|1.0||||0.458|TWO_SIDED|95.0|0.98|1.02|||Mixed Models Analysis|||||1.02|0.98|0.458
71894857|NCT02333331|143311719|SUPERIORITY||Mean Difference (Net)|1.05|||<|0.001|TWO_SIDED|95.0|1.03|1.08|||Mixed Models Analysis|||||1.08|1.03|<0.001
71894858|NCT02333331|143311719|SUPERIORITY||Mean Difference (Net)|1.06|||<|0.001|TWO_SIDED|95.0|1.04|1.07|||Mixed Models Analysis|||||1.07|1.04|<0.001
71894859|NCT03815292|143311746|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
71894860|NCT03815292|143311747|SUPERIORITY|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0445
71894861|NCT03815292|143311748|SUPERIORITY|||||||0.0345|||||||Fisher Exact|||||||0.0345
71894862|NCT03815292|143311749|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.04
71894863|NCT03815292|143311750|SUPERIORITY|||||||0.0016|||||||t-test, 2 sided|||This analysis applies to ∆ between baseline and after 24 weeks total scores row.||||0.0016
71894864|NCT03815292|143311751|SUPERIORITY|||||||0.0054|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Therapeutic effect row.||||0.0054
71676196|NCT04075682|142870120|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.3||0.45|TWO_SIDED|95.0|-0.81|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.81|0.45
71808206|NCT02352948|143118249|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.011|TWO_SIDED|95.0|0.49|0.92|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||0.92|0.49|0.011
71808207|NCT02352948|143118250|OTHER|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Odds Ratio (OR)|3.87|||||TWO_SIDED|95.0|1.61|10.1|||||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.||10.10|1.61|
71808208|NCT02352948|143118250|SUPERIORITY||Odds Ratio (OR)|2.43||||0.037|TWO_SIDED|95.0|1.1|5.94|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||5.94|1.10|0.037
71808209|NCT02352948|143118250|SUPERIORITY||Odds Ratio (OR)|0.97||||0.923|TWO_SIDED|95.0|0.51|1.89|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.||1.89|0.51|0.923
71808210|NCT02352948|143118250|SUPERIORITY||Odds Ratio (OR)|2.46||||0.109|TWO_SIDED|95.0|0.91|8.61|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.||8.61|0.91|0.109
71808211|NCT02352948|143118254|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.002|TWO_SIDED|95.0|0.49|0.85|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.||0.85|0.49|0.002
71808212|NCT00126438|143118275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.73||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.73|0.18|0.001
71808213|NCT00126438|143118275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.001|TWO_SIDED|95.0|0.18|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.18|0.001
71808214|NCT00126438|143118275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.001|TWO_SIDED|95.0|0.17|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.72|0.17|0.001
71808215|NCT01106833|143118281|SUPERIORITY|||||||0.63||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.63
71808216|NCT01106833|143118281|SUPERIORITY|||||||0.44||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.44
71808217|NCT01106833|143118282|SUPERIORITY|||||||0.205||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.205
71843105|NCT04174170|143198765|SUPERIORITY||Treatment Difference|-8.83||||0.0134|TWO_SIDED|95.0|-15.82|-1.85||MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|MMRM|||||-1.85|-15.82|0.0134
71843106|NCT04586244|143198945|SUPERIORITY|||||||0.0925|||||||paired t-test|The paired t-test used n-1 degrees of freedom, where n is the number of evaluable paired samples.||||||0.0925
71894865|NCT03815292|143311751|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Side effects row.||||0.78
71894866|NCT03815292|143311751|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to Efficiency index row.||||0.0042
71894867|NCT03815292|143311752|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.77
71894868|NCT03815292|143311753|SUPERIORITY|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.0118
71894869|NCT03815292|143311754|SUPERIORITY|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between 24 and 28 weeks total scores row.||||0.058
71894870|NCT04243369|143311755|OTHER|Only descriptive statistics was provided. The rate and the exact 95% CI of the rate using the Clopper-Pearson Exact method is calculated.|Rate|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100|88.4|
71808218|NCT01106833|143118283|SUPERIORITY|||||||0.141||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.141
71808219|NCT01106833|143118284|SUPERIORITY|||||||0.775||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.775
71808220|NCT01106833|143118285|SUPERIORITY|||||||0.396||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without relapse was treated as a competing risk||The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.396
71808221|NCT01106833|143118286|SUPERIORITY|||||||0.219||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without initiation of secondary therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.219
71808222|NCT01106833|143118287|SUPERIORITY|||||||0.706||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.706
71808223|NCT01106833|143118288|SUPERIORITY|||||||0.127||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.127
71808224|NCT01106833|143118288|SUPERIORITY|||||||0.562||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.562
71808225|NCT01106833|143118288|SUPERIORITY|||||||0.129||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.129
71808226|NCT01106833|143118289|SUPERIORITY|||||||0.586||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.586
71808227|NCT01106833|143118289|SUPERIORITY|||||||0.14||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.140
71808228|NCT01106833|143118290|SUPERIORITY|||||||0.582||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.582
71808229|NCT01106833|143118290|SUPERIORITY|||||||0.208||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.208
71808230|NCT01106833|143118290|SUPERIORITY|||||||0.431||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.431
71808231|NCT01106833|143118291|SUPERIORITY|||||||0.147||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.147
71808232|NCT01106833|143118291|SUPERIORITY|||||||0.863||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.863
71676197|NCT04075682|142870120|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.25||0.5767|TWO_SIDED|95.0|-0.64|0.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.70|-0.64|0.5767
71677347|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|4.975|||||TWO_SIDED|95.0|3.757|6.589||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.589|3.757|
71808233|NCT01106833|143118292|SUPERIORITY|||||||0.62||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.620
71808234|NCT01106833|143118292|SUPERIORITY|||||||0.258||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.258
71894871|NCT01458340|143311779|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.69||0.6026|ONE_SIDED|95.0||3.2||α=0.05 significance level.|Mixed Model for Repeated Measures (MMRM)|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.2||0.6026
71894872|NCT01458340|143311779|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.69||0.4844|ONE_SIDED|95.0||2.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||2.7||0.4844
71808235|NCT01106833|143118292|SUPERIORITY|||||||0.036||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.036
71808236|NCT01106833|143118292|SUPERIORITY|||||||0.369||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.369
71808237|NCT01106833|143118293|SUPERIORITY|||||||0.45||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.450
71843107|NCT01992913|143198951|SUPERIORITY||||||<|0.05||||||"Fisher's exact Test, right-sided probability based on a directional hypothesis."|Fisher Exact|||We conducted a 2 X 2 chi-square analysis of differences in proportion.||||<.05
71843108|NCT01992913|143198951|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.06|TWO_SIDED|95.0|0.97|7.13|||Chi-squared|ChiSq = 3.6562, df = 1|OR, iCBT / TAU in job attainment|Chis Sq: group (iCBT/TAU) X Job attained (Yes/No)||7.13|0.97|<.06
71843109|NCT01992913|143198952|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.91|<|0.33|TWO_SIDED|95.0|-2.67|0.89|||Mixed Models Analysis|df (1, 30) for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 6 month assessment points.||.89|-2.67|<0.33
71843110|NCT01992913|143198952|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.52|STANDARD_ERROR_OF_MEAN|0.85|<|0.54|TWO_SIDED|95.0|-1.14|2.19|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 12 month assessment points.||2.19|-1.14|<.54
71894873|NCT01458340|143311780|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|2.17||0.5269|ONE_SIDED|95.0||3.7||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||3.7||0.5269
71808238|NCT01106833|143118293|SUPERIORITY|||||||0.301||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.301
71894874|NCT01458340|143311780|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|2.16||0.2092|ONE_SIDED|95.0||1.8||α=0.05 significance level.|MMRM|One-sided p-values were obtained from the pairwise comparisons between TD-9855 group and placebo group based on the final model.||||1.8||0.2092
71808239|NCT01106833|143118293|SUPERIORITY|||||||0.75||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.750
71808240|NCT01106833|143118293|SUPERIORITY|||||||0.444||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.444
71808241|NCT01106833|143118294|SUPERIORITY|||||||0.238||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.238
71808242|NCT01106833|143118294|SUPERIORITY|||||||0.546||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.546
71808243|NCT01106833|143118294|SUPERIORITY|||||||0.756||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.756
71808244|NCT01106833|143118294|SUPERIORITY|||||||0.554||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.554
71808245|NCT01106833|143118295|SUPERIORITY|||||||0.685||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.685
71808246|NCT01106833|143118295|SUPERIORITY|||||||0.105||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.105
71808247|NCT01106833|143118295|SUPERIORITY|||||||0.039||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.039
71676198|NCT04075682|142870121|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.36|-0.98|0.36
71843111|NCT01992913|143198952|SUPERIORITY|A mixed effects logistic regression model was conducted on a binary work variable, with a random intercept, using the baseline measure as a binary covariate.|Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.83|<|0.71|TWO_SIDED|95.0|-1.32|1.73|||Mixed Models Analysis|F (1, 130) = 1.0, p\<0.37, for the group X assessment interaction, adjusting for baseline differences in hours worked at the start of the intervention.||Compare the groups on proportions in employment at the 18 month assessment point.||1.73|-1.32|<0.71
71843112|NCT01992913|143198954|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-5.03|STANDARD_ERROR_OF_MEAN|3.82|<|0.19|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.19
71843113|NCT01992913|143198954|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 6 month assessment.|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|4.42|<|0.99|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.99
71843114|NCT01992913|143198954|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the 12 month assessment.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|4.54|<|0.94|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.94
71843115|NCT01992913|143198954|SUPERIORITY|This is mixed model analysis of the group X assessment interaction. This analysis is the test of mean differences in level of functioning at the baseline assessment.|Mean Difference (Final Values)|-6.67|STANDARD_ERROR_OF_MEAN|4.52|<|0.14|TWO_SIDED||||||Fisher Exact|df (1, 114)||||||<0.14
71843116|NCT00709956|143198981|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-1.5||||0.7883|TWO_SIDED|95.0|-12.3|9.4||If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied|Generalized linear model|Subject (sequence), treatment, and period as fixed effect||With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.||9.4|-12.3|0.7883
71843117|NCT03142009|143199076|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Mixed Models Analysis|||||-.04|-.45|.021
71843118|NCT03142009|143199077|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.075|TWO_SIDED|95.0|-0.01|0.15|||Mixed Models Analysis|||||0.15|-.01|.075
71843119|NCT01499368|143199079|NON_INFERIORITY|Non-inferiority: The Lower limit is not lower than -15%||||||0.05|||||||Chi-squared|||||||0.05
71843120|NCT01499368|143199080|NON_INFERIORITY|Non-Inferiority||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.05
71843121|NCT02720068|143199142|OTHER|Difference in Percentage|Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|-7.3|22.9|||||Confidence interval based on Miettinen \& Nurminen method|||22.9|-7.3|
71843122|NCT02231749|143199157|SUPERIORITY||Stratified Difference|16.0|||<|0.0001|TWO_SIDED|95.0|9.8|22.2|||DerSimonian and Laird Test|||||22.2|9.8|<0.0001
71843123|NCT02231749|143199158|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|99.8|0.44|0.89|||Log Rank|||||0.89|0.44|<0.0001
71843124|NCT02231749|143199159|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0331|TWO_SIDED|99.1|0.64|1.05|||Log Rank|||||1.05|0.64|0.0331
71843125|NCT02231749|143199160|SUPERIORITY||Stratified Difference|7.2||||0.0191|TWO_SIDED|95.0|1.8|12.7|||DerSimonian and Laird Test|||||12.7|1.8|0.0191
71843126|NCT02231749|143199161|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0003|TWO_SIDED|99.8|0.49|0.95|||Log Rank|||||0.95|0.49|0.0003
71843127|NCT02231749|143199162|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8498|TWO_SIDED|99.1|0.79|1.23|||Log Rank|||||1.23|0.79|0.8498
71843128|NCT00357682|143199202|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.24||||0.068|TWO_SIDED|95.0|0.98|1.57|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in low dose PPI (20mg) patients to high dose PPI (80mg) patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and aspirin randomisation group.||1.57|0.98|0.068
71843129|NCT00357682|143199202|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.27||||0.037|TWO_SIDED|95.0|1.01|1.58|||Accelerated Failure Time|||Accelerated Failure Time (AFT) analysis comparing time to primary event in aspirin patients to non-aspirin patients. Included in AFT model are stratification factors (Barrett's length, age group and presence of baseline intestinal metaplasia) and PPI randomisation group.||1.58|1.01|0.037
71843130|NCT00357682|143199203|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.36||||0.039|TWO_SIDED|95.0|1.01|1.82|||Accelerated Failure Time|||All recordings of death, regardless of the cause are used in this analysis and both PPI groups are compared.||1.82|1.01|0.039
71843131|NCT00357682|143199203|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.25||||0.159|TWO_SIDED|95.0|0.92|1.7|||Accelerated Failure Time|||There are 163 deaths in the aspirin comparison with all-cause mortality as the endpoint. Median follow-up is 8.9 years IQR: (8.2 , 10.0) Range: (0 , 11.5)||1.70|0.92|0.159
71843132|NCT00357682|143199204|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.04||||0.864|TWO_SIDED|95.0|0.67|1.61|||Accelerated Failure Time|||There are 81 diagnoses in the PPI dose comparison with adenocarcinoma oesophageal cancer as the endpoint. Median follow-up is 8.7 years IQR: (8.1 , 9.9)||1.61|0.67|0.864
71843133|NCT00357682|143199204|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.02||||0.921|TWO_SIDED|95.0|0.64|1.64|||Accelerated Failure Time|||There are 70 diagnoses of adenocarcinoma in the aspirin comparison. Median follow-up is 8.8 years, IQR: (8.1 , 10), Range: (0 , 11.5)||1.64|0.64|0.921
71808248|NCT01106833|143118295|SUPERIORITY|||||||0.278||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.278
71808249|NCT01106833|143118295|SUPERIORITY|||||||0.804||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.804
71843134|NCT00357682|143199205|SUPERIORITY|5% significance level is considered statistically significant.|Time Ratio|1.36||||0.119|TWO_SIDED|95.0|0.92|2.02|||Accelerated Failure Time|||There are 103 such diagnoses in the PPI dose comparison. Median follow-up is 8.7 years IQR: (8.1 , 9.9) Range: (0 , 11.48)||2.02|0.92|0.119
71843135|NCT00357682|143199205|SUPERIORITY|5% significance level is considered statistically significant|Time Ratio|1.51||||0.053|TWO_SIDED|95.0|1.0|2.29|||Accelerated Failure Time|||There are a total of 92 conversions to HGD in the aspirin comparison. Median follow-up is 8.8 years IQR (8.1 , 10.0) Range (0 , 11.5)||2.29|1.00|0.053
71843136|NCT05495945|143199274|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71808250|NCT01106833|143118296|SUPERIORITY|||||||0.631||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.631
71843137|NCT05495945|143199275|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71843138|NCT05495945|143199276|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.20
71843139|NCT05495945|143199277|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71843140|NCT03215706|143199284|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.69||||0.0006|TWO_SIDED|95.0|0.56|0.86|||Log-rank test stratified|||||0.86|0.56|0.0006
71843141|NCT03215706|143199285|SUPERIORITY|Treatment A over Treatment B|Hazard Ratio (HR)|0.7||||0.0001|TWO_SIDED|95.0|0.58|0.84|||Log-rank test stratified|||||0.84|0.58|0.0001
71843142|NCT03215706|143199286|SUPERIORITY|Treatment A over Treatment B|Odds Ratio (OR)|1.81||||0.0003|TWO_SIDED|95.0|1.31|2.5|||Mantel Haenszel|||||2.50|1.31|0.0003
71843143|NCT05412004|143199301|SUPERIORITY||LS Mean Change difference|-20.01|||<|0.001|TWO_SIDED|95.0|-25.82|-14.2|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-14.20|-25.82|<0.001
71843144|NCT05412004|143199301|SUPERIORITY||LS Mean Change difference|-23.77|||<|0.001|TWO_SIDED|95.0|-29.61|-17.93|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-17.93|-29.61|<0.001
71843145|NCT05412004|143199302|SUPERIORITY||LS Mean Change difference|-47.65|||<|0.001|TWO_SIDED|95.0|-65.76|-29.55|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-29.55|-65.76|<0.001
71843146|NCT05412004|143199302|SUPERIORITY||LS Mean Change difference|-56.21|||<|0.001|TWO_SIDED|95.0|-73.73|-38.7|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, treatment (Type III sum of squares) as covariates.||||-38.70|-73.73|<0.001
71843147|NCT05412004|143199303|SUPERIORITY||Risk Difference (RD)|42.77|||<|0.001|TWO_SIDED|95.0|30.76|54.79|||Regression, Logistic|||||54.79|30.76|<0.001
71843148|NCT05412004|143199303|SUPERIORITY||Risk Difference (RD)|48.6|||<|0.001|TWO_SIDED|95.0|36.55|60.65|||Regression, Logistic|||||60.65|36.55|<0.001
71843149|NCT05412004|143199304|SUPERIORITY||Risk Difference (RD)|28.74|||<|0.001|TWO_SIDED|95.0|18.27|39.22|||Regression, Logistic|||||39.22|18.27|<.001
71843150|NCT05412004|143199304|SUPERIORITY||Risk Difference (RD)|33.22|||<|0.001|TWO_SIDED|95.0|22.12|44.31|||Regression, Logistic|||||44.31|22.12|<0.001
71843151|NCT05412004|143199305|SUPERIORITY||Median Difference (Net)|-70.13|STANDARD_ERROR_OF_MEAN|10.619|||TWO_SIDED|95.0|-90.94|-49.31||||||||-49.31|-90.94|
71843152|NCT05412004|143199305|SUPERIORITY||Median Difference (Net)|-61.29|STANDARD_ERROR_OF_MEAN|11.921|||TWO_SIDED|95.0|-84.66|-37.93||||||||-37.93|-84.66|
71843153|NCT05412004|143199306|SUPERIORITY||LS Mean Change difference|-2.03||||0.037|TWO_SIDED|95.0|-3.95|-0.12|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-0.12|-3.95|0.037
71843154|NCT05412004|143199306|SUPERIORITY||LS Mean Change difference|-3.43||||0.003|TWO_SIDED|95.0|-5.69|-1.17|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Related Impairment||-1.17|-5.69|0.003
71843155|NCT05412004|143199306|SUPERIORITY||LS Mean Change difference|-3.9|||<|0.001|TWO_SIDED|95.0|-6.21|-1.58|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep Disturbance||-1.58|-6.21|<0.001
71843156|NCT05412004|143199306|SUPERIORITY||LS Mean Change difference|-4.26||||0.002|TWO_SIDED|95.0|-6.97|-1.56|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||Sleep-Related Impairment||-1.56|-6.97|0.002
71843157|NCT05412004|143199307|SUPERIORITY||LS Mean Change difference|-16.09|||<|0.001|TWO_SIDED|95.0|-17.99|-14.19|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-14.19|-17.99|<0.001
71843158|NCT05412004|143199307|SUPERIORITY||LS Mean Change difference|-17.28|||<|0.001|TWO_SIDED|95.0|-19.29|-15.28|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-15.28|-19.29|<.001
71808251|NCT01106833|143118296|SUPERIORITY|||||||0.759||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.759
71808252|NCT01106833|143118296|SUPERIORITY|||||||0.391||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.391
71808253|NCT01106833|143118296|SUPERIORITY|||||||0.222||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.222
71808254|NCT01106833|143118296|SUPERIORITY|||||||0.527||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.527
71808255|NCT01106833|143118297|SUPERIORITY|||||||0.763||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.763
71808256|NCT01106833|143118297|SUPERIORITY|||||||0.133||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.133
71808257|NCT01106833|143118297|SUPERIORITY|||||||0.953||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.953
71808258|NCT01106833|143118297|SUPERIORITY|||||||0.398||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.398
71808259|NCT01106833|143118297|SUPERIORITY|||||||0.309||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.||||0.309
71808260|NCT00886340|143118302|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||controlled for site, income, race/ethnicity|Mixed Models Analysis|||pilot test, used 20% of sample required for a full test of the hypothesis||||0.08
71808261|NCT02120027|143118353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.986||||0.949|TWO_SIDED|95.0|0.64|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.64|0.949
71808262|NCT02120027|143118354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.193|TWO_SIDED|95.0|0.88|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.88|0.193
71808263|NCT02120027|143118355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.872|TWO_SIDED|95.0|0.7|1.53|||Cochran-Mantel-Haenszel|||||1.53|0.70|0.872
71808264|NCT02120027|143118356|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.339||||0.272|TWO_SIDED|95.0|0.79|2.26|||Cochran-Mantel-Haenszel|||||2.26|0.79|0.272
71808265|NCT02120027|143118357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.153||||0.567|TWO_SIDED|95.0|0.73|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.73|0.567
71808266|NCT01002872|143118358|SUPERIORITY|||||||0.037|||||||t-test, 2 sided|||||||0.037
71808267|NCT01002872|143118359|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
71808268|NCT01002872|143118360|SUPERIORITY|||||||0.897|||||||t-test, 2 sided|||||||0.897
71808269|NCT01002872|143118361|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
71808270|NCT01002872|143118362|SUPERIORITY|||||||0.416|||||||t-test, 2 sided|||||||0.416
71808271|NCT01002872|143118363|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
71808272|NCT01002872|143118364|SUPERIORITY|||||||0.955|||||||t-test, 2 sided|||||||0.955
71808273|NCT01002872|143118365|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71808274|NCT01002872|143118366|SUPERIORITY|||||||0.0066|||||||t-test, 2 sided|||||||0.0066
71808275|NCT00414817|143118367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018||||0.002|TWO_SIDED|95.0|0.006|0.03|||Regression, Linear|2-tailed p-value based on linear regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|Estimated adherence was approximately 2 percentage points higher for intervention group than for usual care group.|In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.||.030|.006|.002
71808276|NCT00414817|143118368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.175|TWO_SIDED|95.0|-0.23|0.04|||Regression, Linear|2-tailed p-value adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline adherence.||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||0.04|-0.23|0.175
71894875|NCT03351244|143311829|OTHER||Hazard Ratio (HR)|1.097||||0.7735|TWO_SIDED|95.0|0.585|2.056|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.056|0.585|0.7735
71894876|NCT03351244|143311829|OTHER||Hazard Ratio (HR)|0.91||||0.7809|TWO_SIDED|95.0|0.468|1.77|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.770|0.468|0.7809
71894877|NCT03351244|143311829|OTHER||Hazard Ratio (HR)|1.005||||0.9862|TWO_SIDED|95.0|0.576|1.753|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.753|0.576|0.9862
71894878|NCT03351244|143311830|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.38||||0.5289|TWO_SIDED|95.0|-0.809|1.57|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.570|-0.809|0.5289
71894879|NCT03351244|143311830|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.21||||0.744|TWO_SIDED|95.0|-1.055|1.475|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.475|-1.055|0.7440
71894880|NCT03351244|143311830|OTHER|A restricted maximum likelihood-based approach using a mixed model with repeated measurements was applied.|Placebo-corrected adjusted mean|0.31||||0.5659|TWO_SIDED|95.0|-0.745|1.358|||Mixed model with repeated measurements|The analysis included the fixed, categorical effects of treatment at each visit, and the fixed continuous effects of baseline at each visit.||||1.358|-0.745|0.5659
71894881|NCT03351244|143311833|OTHER||Hazard Ratio (HR)|1.006||||0.9938|TWO_SIDED|95.0|0.203|4.989|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.989|0.203|0.9938
71894882|NCT03351244|143311833|OTHER||Hazard Ratio (HR)|1.116||||0.893|TWO_SIDED|95.0|0.225|5.531|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||5.531|0.225|0.8930
71808277|NCT00414817|143118369|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.852|TWO_SIDED|95.0|0.96|1.06||2-tailed p-value based on overdispersed Poisson regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|overdispersed Poisson regression|||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.||1.06|0.96|0.852
71808278|NCT00447057|143118371|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.0047|TWO_SIDED|95.0|0.438|0.897|||Log Rank|Log-rank test with 1-sided alpha of 0.20||||0.897|0.438|0.0047
71808279|NCT00447057|143118372|SUPERIORITY_OR_OTHER|||||||0.3909|||||||Fisher Exact|||||||0.3909
71808280|NCT00447057|143118373|SUPERIORITY_OR_OTHER|||||||0.1808|||||||Fisher Exact|||||||0.1808
71808281|NCT00447057|143118374|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0034|TWO_SIDED|95.0|0.457|0.887||1-sided significance level of 0.20|Log Rank|||||0.887|0.457|0.0034
71808282|NCT00447057|143118375|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.019|TWO_SIDED|95.0|0.465|0.981||1-sided significance level of 0.20|Log Rank|||||0.981|0.465|0.0190
71894883|NCT03351244|143311833|OTHER||Hazard Ratio (HR)|1.058||||0.936|TWO_SIDED|95.0|0.265|4.233|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||4.233|0.265|0.9360
71808283|NCT04493216|143118433|OTHER||Differences in percentage of participant|-9.2|||||TWO_SIDED|95.0|-24.0|5.7|||||Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF|||5.7|-24.0|
71808284|NCT04493216|143118433|OTHER||Differences in percentage of participant|-1.0|||||TWO_SIDED|95.0|-13.5|11.6|||||Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||11.6|-13.5|
71808285|NCT04493216|143118433|OTHER||Differences in percentage of participant|-15.5|||||TWO_SIDED|95.0|-31.2|0.3|||||Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF|||0.3|-31.2|
71808286|NCT05090709|143118493|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
71808287|NCT05090709|143118493|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Stiffness values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
71808288|NCT05090709|143118498|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
71808289|NCT05090709|143118498|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
71808290|NCT05090709|143118503|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
71808291|NCT05090709|143118503|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Sit-to-stand velocity values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
71808292|NCT05090709|143118508|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808293|NCT05090709|143118508|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808294|NCT05090709|143118510|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||< 0.05
71808295|NCT05090709|143118510|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including both time points in the analysis.||||||> 0.05
71808296|NCT05090709|143118515|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
71894884|NCT03351244|143311835|OTHER||Hazard Ratio (HR)|0.788||||0.6362|TWO_SIDED|95.0|0.293|2.118|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||2.118|0.293|0.6362
71894885|NCT03351244|143311835|OTHER||Hazard Ratio (HR)|0.612||||0.3782|TWO_SIDED|95.0|0.205|1.826|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.826|0.205|0.3782
71894886|NCT03351244|143311835|OTHER||Hazard Ratio (HR)|0.703||||0.4253|TWO_SIDED|95.0|0.296|1.671|||Regression, Cox|The model included the treatment effect as the only covariate and was stratified by country.||||1.671|0.296|0.4253
71894887|NCT00091793|143311845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|6.2|7.8|||ANCOVA|||||7.8|6.2|<0.0001
71894888|NCT01165229|143311859|OTHER|The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.|Vaccine efficacy|90.02|||<|0.0001|TWO_SIDED|95.0|83.54|94.32|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.||94.32|83.54|<0.0001
71894889|NCT01165229|143311859|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.08|||<|0.0001|TWO_SIDED|95.0|74.65|96.16|||Poisson exact method|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo \>=80YOA Group||96.16|74.65|<0.0001
71808297|NCT05090709|143118515|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||Muscle tone values were analysed as a percentage change from baseline measurements to normalise group variances.||||> 0.05
71894890|NCT01165229|143311859|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.79|||<|0.0001|TWO_SIDED|95.0|84.29|93.66|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||93.66|84.29|<0.0001
71894891|NCT01165229|143311860|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|93.04|||<|0.0001|TWO_SIDED|95.0|72.47|99.19|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||99.19|72.47|<0.0001
71808298|NCT05090709|143118520|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808299|NCT05090709|143118520|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808300|NCT05090709|143118525|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808301|NCT05090709|143118525|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808302|NCT05090709|143118530|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
71808303|NCT05090709|143118530|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808304|NCT05090709|143118535|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808305|NCT05090709|143118535|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
71843159|NCT05412004|143199308|SUPERIORITY||LS Mean Change difference|-0.71|STANDARD_ERROR_OF_MEAN|0.253||0.752|TWO_SIDED|95.0|-1.21|-0.22||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.22|-1.21|0.752
71843160|NCT05412004|143199308|SUPERIORITY||LS Mean Change difference|-1.04|STANDARD_ERROR_OF_MEAN|0.269||0.35|TWO_SIDED|95.0|-1.57|-0.51||ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.|ANCOVA|||||-0.51|-1.57|0.350
71843161|NCT05412004|143199309|SUPERIORITY||LS Mean Change difference|-7.62|||<|0.001|TWO_SIDED|95.0|-10.48|-4.77|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-4.77|-10.48|<0.001
71843162|NCT05412004|143199309|SUPERIORITY||LS Mean difference|-3.7||||0.017|TWO_SIDED|95.0|-6.75|-0.65|||ANCOVA|ANCOVA model was used with baseline, geographic region, sex, baseline OSA severity Group, treatment (Type III sum of squares) as covariates.||||-0.65|-6.75|0.017
71843163|NCT03868930|143199388|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
71808306|NCT05090709|143118540|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808307|NCT05090709|143118540|SUPERIORITY||||||>|0.05||||||A priori threshold for statistical significance is 0.05.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||> 0.05
71808308|NCT05090709|143118545|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
71808309|NCT05090709|143118545|SUPERIORITY||||||<|0.05||||||Including partial eta squared large effect size.|ANOVA|Repeated measures ANOVA including all 5 time points in the analysis.||||||< 0.05
71808310|NCT00713648|143118546|SUPERIORITY_OR_OTHER||Mean (Lambda)|0.048||||||95.0|0.0094|0.2501|||Poisson model (log-link)|The estimated rate was adjusted for age and overdispersion which was estimated by Pearson's chi-square statistic divided by its degrees of freedom.|Mean (Lambda) refer to the estimate of the annualised bleeding rate|||0.2501|0.0094|
71808311|NCT02161133|143118561|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.62||0.712|TWO_SIDED||||||Mixed Models Analysis|||||||0.712
71894892|NCT01165229|143311860|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|71.16||||0.1844|TWO_SIDED|95.0|-51.51|97.08|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||97.08|-51.51|0.1844
71894893|NCT01165229|143311860|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|88.78|||<|0.0001|TWO_SIDED|95.0|68.7|97.1|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A \>=70YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||97.10|68.70|<0.0001
71894894|NCT01165229|143311861|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.27|||<|0.0001|TWO_SIDED|95.0|86.04|94.85|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group||94.85|86.04|<0.0001
71894895|NCT01165229|143311861|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.37|||<|0.0001|TWO_SIDED|95.0|80.22|96.94|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A \>=80YOA Group and Zoster-022/006 Pooled Placebo \>=80YOA Group||96.94|80.22|<0.0001
71894896|NCT01165229|143311861|OTHER|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.3|||<|0.0001|TWO_SIDED|95.0|86.88|94.46|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 Pooled Placebo \>=70YOA Group||94.46|86.88|<0.0001
71808312|NCT02161133|143118562|SUPERIORITY||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|2.48||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
71808313|NCT02161133|143118563|SUPERIORITY||Mean Difference (Final Values)|12.23|STANDARD_ERROR_OF_MEAN|10.45||0.244|TWO_SIDED||||||Mixed Models Analysis|||||||0.244
71808314|NCT02161133|143118564|SUPERIORITY||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|1.95||0.057|TWO_SIDED||||||Mixed Models Analysis|||||||0.057
71808315|NCT02161133|143118565|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.57||0.382|TWO_SIDED||||||Mixed Models Analysis|||||||0.382
71808316|NCT02161133|143118566|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.703|TWO_SIDED||||||Mixed Models Analysis|||||||0.703
71808317|NCT02161133|143118567|SUPERIORITY||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|1.36||0.168|TWO_SIDED||||||Mixed Models Analysis|||||||0.168
71808318|NCT02161133|143118568|SUPERIORITY||Mean Difference (Final Values)|-7.28|STANDARD_ERROR_OF_MEAN|2.93||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
71808319|NCT04341116|143118581|SUPERIORITY||Median Difference (Final Values)|9.0|STANDARD_ERROR_OF_MEAN|8.5||0.28|TWO_SIDED|95.0|-6.5|27.0|||Fisher Exact|||||27|-6.5|.28
71808320|NCT00423176|143118608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.44||||||95.0|-1.14|0.25|||||For days 1-29|||0.25|-1.14|
71808321|NCT00423176|143118608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.82||||||95.0|-1.65|0.0|||||For follow-up days 30-43|||0.00|-1.65|
71808322|NCT00423176|143118609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.8||||||95.0|-0.5|18.2|||||Change from baseline to endpoint|||18.2|-0.5|
71808323|NCT05554237|143118617|OTHER||Ratio of adjusted geometric means|83.46|||||TWO_SIDED|90.0|74.67|93.29|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only)|||93.29|74.67|
71808324|NCT05554237|143118619|OTHER||Ratio of adjusted geometric means|89.7|||||TWO_SIDED|90.0|87.24|92.23|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.23|87.24|
71808325|NCT05554237|143118622|OTHER||Ratio of adjusted geometric means|89.91|||||TWO_SIDED|90.0|87.47|92.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (for CTB 800 mg + AVP 1350 mg versus CTB 800mg only|||92.41|87.47|
71808326|NCT05554237|143118642|OTHER||Ratio of adjusted geometric mean|104.47|||||TWO_SIDED|90.0|84.94|128.5|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||128.50|84.94|
71808327|NCT05554237|143118642|OTHER||Ratio of adjusted geometric mean|129.54|||||TWO_SIDED|90.0|119.37|140.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||140.58|119.37|
71808328|NCT05554237|143118642|OTHER||Ratio of adjusted geometric mean|101.46|||||TWO_SIDED|90.0|88.68|116.08|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||116.08|88.68|
71808329|NCT05554237|143118642|OTHER||Ratio of adjusted geometric means|86.99|||||TWO_SIDED|90.0|74.48|101.59|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||101.59|74.48|
71808330|NCT05554237|143118644|OTHER||Ratio of adjusted geometric mean|102.21|||||TWO_SIDED|90.0|88.67|117.8|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||117.80|88.67|
71808331|NCT05554237|143118644|OTHER||Ratio of adjusted geometric mean|133.79|||||TWO_SIDED|90.0|119.84|149.36|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||149.36|119.84|
71808332|NCT05554237|143118644|OTHER||Ratio of adjusted geometric mean|99.93|||||TWO_SIDED|90.0|90.7|110.1|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|Cis-CTB Day 6 versus Day 7||110.10|90.70|
71808333|NCT05554237|143118644|OTHER||Ratio of adjusted geometric mean|89.17|||||TWO_SIDED|90.0|75.27|105.63|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted) for CTB 400 mg + AVP 1350 mg only|Trans-CTB Day 6 versus Day 7||105.63|75.27|
71894897|NCT01165229|143311862|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|90.8|||<|0.0001|TWO_SIDED|95.0|62.57|98.95|||Poisson exact test|||Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group||98.95|62.57|<0.0001
71808334|NCT05554237|143118650|OTHER||Ratio of adjusted geometric mean|93.69|||||TWO_SIDED|90.0|78.37|112.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||112.02|78.37|
71808335|NCT05554237|143118650|OTHER||Ratio of adjusted geometric mean|113.07|||||TWO_SIDED|90.0|88.31|144.76|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI-CTB Day 6 versus Day 7||144.76|88.31|
71808336|NCT05554237|143118650|OTHER||Ratio of adjusted geometric mean|107.06||||||90.0|92.77|123.54|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||123.54|92.77|
71808337|NCT05554237|143118650|OTHER||Ratio of adjusted geometric mean|80.68|||||TWO_SIDED|90.0|68.32|95.27|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||95.27|68.32|
71808338|NCT05554237|143118650|OTHER||Ratio of adjusted geometric mean|89.92|||||TWO_SIDED|90.0|69.7|116.02|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||116.02|69.70|
71808339|NCT05554237|143118650|OTHER||Ratio of adjusted geometric mean|97.65|||||TWO_SIDED|90.0|84.08|113.41|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||113.41|84.08|
71808340|NCT05554237|143118651|OTHER||Ratio of adjusted geometric mean|102.33|||||TWO_SIDED|90.0|90.37|115.87|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||115.87|90.37|
71808341|NCT05554237|143118651|OTHER||Ratio of adjusted geometric mean|117.83|||||TWO_SIDED|90.0|100.61|138.0|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||138.00|100.61|
71808342|NCT05554237|143118651|OTHER||Ratio of adjusted geometric mean|115.88|||||TWO_SIDED|90.0|104.12|128.98|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|AVI- Day 6 versus Day 7||128.98|104.12|
71808343|NCT05554237|143118651|OTHER||Ratio of adjusted geometric mean|85.27|||||TWO_SIDED|90.0|70.37|103.32|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||103.32|70.37|
71808344|NCT05554237|143118651|OTHER||Ratio of adjusted geometric mean|97.69|||||TWO_SIDED|90.0|78.83|121.06|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||121.06|78.83|
71808345|NCT05554237|143118651|OTHER||Ratio of adjusted geometric mean|102.85|||||TWO_SIDED|90.0|94.8|111.58|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (fed vs fasted)|HPA- Day 6 versus Day 7||111.58|94.80|
71808346|NCT05554237|143118666|OTHER||Ratio of adjusted geometric mean|105.47|||||TWO_SIDED|90.0|86.64|128.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||128.39|86.64|
71808347|NCT05554237|143118666|OTHER||Ratio of adjusted geometric mean|134.24||||||90.0|51.81|347.81|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||347.81|51.81|
71843164|NCT03868930|143199388|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
71843165|NCT03868930|143199388|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
71894898|NCT01165229|143311862|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|65.76||||0.3072|TWO_SIDED|95.0|-91.58|96.62|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||96.62|-91.58|0.3072
71808348|NCT05554237|143118666|OTHER||Ratio of adjusted geometric mean|91.17||||||90.0|79.54|104.51|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||104.51|79.54|
71808349|NCT05554237|143118666|OTHER||Ratio of adjusted geometric mean|115.26|||||TWO_SIDED|90.0|71.46|185.9|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||185.90|71.46|
71808350|NCT05554237|143118668|OTHER||Ratio of adjusted geometric mean|114.83|||||TWO_SIDED|90.0|101.1|130.43|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||130.43|101.10|
71808351|NCT05554237|143118668|OTHER||Ratio of adjusted geometric mean|140.44|||||TWO_SIDED|90.0|104.17|189.34|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|AVI- Day 6 versus Day 7||189.34|104.17|
71808352|NCT05554237|143118668|OTHER||Ratio of adjusted geometric mean|101.46||||||90.0|90.79|113.39|||||Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||113.39|90.79|
71894899|NCT01165229|143311862|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|85.49|||<|0.0001|TWO_SIDED|95.0|58.52|96.3|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||96.30|58.52|<0.0001
71808353|NCT05554237|143118668|OTHER||Ratio of adjusted geometric means|123.2|||||TWO_SIDED|90.0|110.25|137.67|||||Model is a mixed effect model with treatment as a fixed effect and participant as a random effect (Japanese participants fed vs fasted and Chinese participants fed vs fasted)|HPA- Day 6 versus Day 7||137.67|110.25|
71808354|NCT02395042|143118674|SUPERIORITY||Least Squares Mean Difference|-1.15||||0.142|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.142
71808355|NCT02395042|143118674|SUPERIORITY||Least Squares Mean Difference|-0.92||||0.319|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.319
71808356|NCT02395042|143118675|SUPERIORITY||Least Squares Mean Difference|-1.46||||0.024|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.024
71808357|NCT02395042|143118675|SUPERIORITY||Least Squares Mean Difference|-1.02||||0.137|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors.||||||0.137
71808358|NCT00989768|143118699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_DEVIATION|0.36|<|0.0001||95.0|||||t-test, 2 sided|||In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.||||<0.0001
71808359|NCT00989768|143118700|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71808360|NCT00989768|143118701|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
71808361|NCT00989768|143118702|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
71843166|NCT03868930|143199388|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on reintegration (measured by the Military to Civilian Questionnaire).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
71843167|NCT03868930|143199389|SUPERIORITY|||||||0.0044||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0044
71894900|NCT01165229|143311863|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|21.7||||0.3749|TWO_SIDED|95.0|-34.4|54.39|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||54.39|-34.40|0.3749
71808362|NCT03492281|143118718|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2||Hypothesis testing was performed for vibegron minus placebo.|Mixed Model for Repeated Measures (MMRM)|||||-0.2|-0.8|<0.001
71808363|NCT03492281|143118718|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16|=|0.0988|TWO_SIDED|95.0|-0.6|0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.1|-0.6|=0.0988
71808364|NCT03492281|143118719|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.3||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.3|-0.9|<0.0001
71808365|NCT03492281|143118719|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15|=|0.0123|TWO_SIDED|95.0|-0.7|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.7|=0.0123
71808366|NCT03492281|143118720|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.22|=|0.002|TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-1.1|=0.0020
71808367|NCT03492281|143118720|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23|=|0.0648|TWO_SIDED|95.0|-0.9|0.0||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||0.0|-0.9|=0.0648
71808368|NCT03492281|143118721|SUPERIORITY||Difference in percentage|16.5|||<|0.0001|TWO_SIDED|95.0|9.7|23.4|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||23.4|9.7|<0.0001
71808369|NCT03492281|143118721|SUPERIORITY||Difference in percentage|9.4|||=|0.012|TWO_SIDED|95.0|2.1|16.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||16.7|2.1|=0.0120
71808370|NCT03492281|143118722|SUPERIORITY||Difference in percentage|6.3|||=|0.036|TWO_SIDED|95.0|0.4|12.1|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||12.1|0.4|=0.0360
71808371|NCT03492281|143118722|SUPERIORITY||Difference in percentage|1.9|||=|0.5447|TWO_SIDED|95.0|-4.1|7.8|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||7.8|-4.1|=0.5447
71808372|NCT03492281|143118723|SUPERIORITY||Difference in percentage|6.8|||=|0.0235|TWO_SIDED|95.0|0.9|12.7|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||12.7|0.9|=0.0235
71808373|NCT03492281|143118723|SUPERIORITY||Difference in percentage|3.7|||=|0.24|TWO_SIDED|95.0|-2.5|10.0|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex and OAB type (wet/dry), with weights proposed by Greenland and Robins.||||10.0|-2.5|=0.2400
71894901|NCT01165229|143311863|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|51.76||||0.2466|TWO_SIDED|95.0|-65.55|85.95|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo\>=80YOA Group||85.95|-65.55|0.2466
71843168|NCT03868930|143199389|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||<.0001
71894902|NCT01165229|143311863|OTHER|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|28.4||||0.1877|TWO_SIDED|95.0|-17.69|56.44|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo\>=70YOA Group||56.44|-17.69|0.1877
71808374|NCT03492281|143118724|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.4|-1.0|<0.0001
71808375|NCT03492281|143118724|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|=|0.0074|TWO_SIDED|95.0|-0.8|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.8|=0.0074
71808376|NCT03492281|143118725|SUPERIORITY||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|1.24|=|0.0039|TWO_SIDED|95.0|1.2|6.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||6.0|1.2|=0.0039
71808377|NCT03492281|143118725|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.32|=|0.021|TWO_SIDED|95.0|0.5|5.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||5.7|0.5|=0.0210
71808378|NCT03492281|143118726|SUPERIORITY||Least Squares Mean Difference|21.2|STANDARD_ERROR_OF_MEAN|3.52|<|0.0001|TWO_SIDED|95.0|14.3|28.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||28.1|14.3|<0.0001
71808379|NCT03492281|143118726|SUPERIORITY||Least Squares Mean Difference|13.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|5.9|20.7||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||20.7|5.9|<0.001
71843169|NCT03868930|143199389|SUPERIORITY|||||||0.0162||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0162
71843170|NCT03868930|143199389|SUPERIORITY|||||||0.0009||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3).|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on readjustment (measured by the Post Deployment Readjustment Inventory).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups~Statistical analysis reported on the total score only."||||0.0009
71808380|NCT03492281|143118727|SUPERIORITY||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.06|<|0.001|TWO_SIDED|95.0|1.7|5.8||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||5.8|1.7|<0.001
71808381|NCT03492281|143118727|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|1.13|=|0.0114|TWO_SIDED|95.0|0.6|5.1|||MMRM|||||5.1|0.6|=0.0114
71808382|NCT03492281|143118728|SUPERIORITY||Least Squares Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.2|-4.6||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-4.6|-9.2|<0.0001
71808383|NCT03492281|143118728|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.25|<|0.001|TWO_SIDED|95.0|-7.1|-2.2||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-2.2|-7.1|<0.001
71808384|NCT03492281|143118729|SUPERIORITY||Difference in percentage|12.4|||<|0.0001|TWO_SIDED|95.0|6.7|18.1||CMH=Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||18.1|6.7|<0.0001
71808385|NCT03492281|143118729|SUPERIORITY||Difference in percentage|6.9|||=|0.0236|TWO_SIDED|95.0|0.9|12.8|||Cochran-Mantel-Haenszel|The CMH risk difference estimate was stratified by OAB type (wet/dry) and sex (female/male), with weights proposed by Greenland and Robins.||||12.8|0.9|=0.0236
71808386|NCT03492281|143118730|SUPERIORITY||Difference in percentage|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.6|4.7|<0.001
71808387|NCT03492281|143118730|SUPERIORITY||Difference in percentage|11.5|||=|0.0022|TWO_SIDED|95.0|4.2|18.9|||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel risk difference estimate was stratified by sex (female/male), with weights proposed by Greenland and Robins.||||18.9|4.2|=0.0022
71808388|NCT03492281|143118731|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.1|-0.3|<0.0001
71808389|NCT03492281|143118731|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05|=|0.0055|TWO_SIDED|95.0|-0.2|0.0||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||0.0|-0.2|=0.0055
71808390|NCT03492281|143118732|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Hypothesis testing was performed for vibegron minus placebo.|MMRM|||||-0.2|-0.4|<0.0001
71808391|NCT03492281|143118732|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3|-0.1||Comparisons between tolterodine ER and placebo are considered descriptive.|MMRM|||||-0.1|-0.3|<0.001
71894903|NCT01165229|143311866|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.2533|TWO_SIDED|95.0|-144.13|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||100.00|-144.13|0.2533
71894904|NCT01165229|143311866|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.5024|TWO_SIDED|95.0|-435.14|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-435.14|0.5024
71894905|NCT01165229|143311866|OTHER|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.0636|TWO_SIDED|95.0|-9.92|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||100.00|-9.92|0.0636
71894906|NCT01165229|143311867|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.|Vaccine efficacy|-65.69||||0.4947|TWO_SIDED|95.0|-827.06|73.62|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||73.62|-827.06|0.4947
71894907|NCT01165229|143311867|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-558.05|100.0|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||100.00|-558.05|1.0000
71808392|NCT01506193|143118733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.04|||||TWO_SIDED|95.0|-1.82|2.78||||||"Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1."||2.78|-1.82|
71808393|NCT01506193|143118733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|1.29|||||TWO_SIDED|95.0|-3.04|6.67||||||"Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1."||6.67|-3.04|
71808394|NCT01506193|143118733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.23|2.29||||||"Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1."||2.29|-1.23|
71808395|NCT01506193|143118733|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be \[-10%\] or higher.|Difference in percentage|-0.33|||||TWO_SIDED|95.0|-1.87|2.03||||||"Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1."||2.03|-1.87|
71808396|NCT01506193|143118734|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be \[-10%\] or higher.|Difference in percentage|-1.02|||||TWO_SIDED|95.0|-3.39|2.24||||||"Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination."||2.24|-3.39|
71808397|NCT02046980|143118743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.02839|TWO_SIDED|95.0|1.58|7.31|||Regression, Logistic|||||7.31|1.58|0.02839
71894908|NCT01165229|143311867|OTHER|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|0.97||||1|TWO_SIDED|95.0|-433.32|83.16|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||83.16|-433.32|1.0000
71894909|NCT01165229|143311868|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|43.42||||0.0112|TWO_SIDED|95.0|10.77|70.53|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||70.53|10.77|0.0112
71894910|NCT01165229|143311868|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%|Vaccine efficacy|27.03||||0.3903|TWO_SIDED|95.0|-26.43|73.2|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||73.20|-26.43|0.3903
71808398|NCT02046980|143118743|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67||||0.0366|TWO_SIDED|95.0|1.25|5.67|||Regression, Logistic|||||5.67|1.25|0.0366
71894911|NCT01165229|143311868|OTHER|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|39.6||||0.0083|TWO_SIDED|95.0|10.79|64.75|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A \>=70YOA group and Zoster-022 Placebo \>=70YOA Group||64.75|10.79|0.0083
71894912|NCT01165229|143311869|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|58.94||||0.0232|TWO_SIDED|95.0|11.45|80.96|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group||80.96|11.45|0.0232
71808399|NCT04575467|143118750|SUPERIORITY||Mean absolute fat thickness difference|-4.77|STANDARD_DEVIATION|2.29|<|0.01|TWO_SIDED|95.0|-7.17|-2.37|||Paired t-test|||||-2.37|-7.17|<0.01
71808400|NCT04575467|143118750|SUPERIORITY||Mean absolute fat thickness difference|-4.85|STANDARD_DEVIATION|2.02|<|0.01|TWO_SIDED|95.0|-6.97|-2.73|||Paired t-test|||||-2.73|-6.97|<0.01
71808401|NCT04575467|143118750|SUPERIORITY||Mean absolute fat thickness difference|-2.98|STANDARD_DEVIATION|2.83|<|0.05|TWO_SIDED|95.0|-5.95|-0.01|||Paired t-test|||||-0.01|-5.95|<0.05
71808402|NCT04575467|143118751|SUPERIORITY||Mean absolute fat volume difference|-114.4|STANDARD_DEVIATION|54.88|<|0.01|TWO_SIDED|95.0|-171.99|-56.81|||Paired t-test|||||-56.81|-171.99|<0.01
71808403|NCT04575467|143118751|SUPERIORITY||Mean absolute fat volume difference|-155.2|STANDARD_DEVIATION|64.7|<|0.01|TWO_SIDED|95.0|-223.1|-87.3|||Paired t-test|||||-87.30|-223.10|<0.01
71808404|NCT04575467|143118751|SUPERIORITY||Mean absolute fat volume difference|-119.17|STANDARD_DEVIATION|113.11|<|0.05|TWO_SIDED|95.0|-237.86|-0.47|||Paired t-test|||||-0.47|-237.86|<0.05
71808405|NCT01483924|143118762|SUPERIORITY_OR_OTHER|||||||0.9048|TWO_SIDED||||||ANOVA|||The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group||||0.9048
71808406|NCT01483924|143118763|SUPERIORITY_OR_OTHER|||||||0.1975|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.1975
71808407|NCT01483924|143118764|SUPERIORITY_OR_OTHER|||||||0.6349|TWO_SIDED||||||Kruskal-Wallis|||||||0.6349
71808408|NCT01483924|143118765|SUPERIORITY_OR_OTHER|||||||0.6212|TWO_SIDED||||||Kruskal-Wallis|||||||0.6212
71808409|NCT03565887|143118789|SUPERIORITY|The primary efficacy endpoints were tested sequentially. The Day 1 Hour 6 time point was tested first and if P\<0.05, the Day 14 Hour 2 time point was tested at a significance level of 0.05. If the Day 1 Hour 6 endpoint is statistically significant (at the 0.05 level) but Day 14 Hour 2 was not statistically significant (at the 0.05 level), the study will still be considered positive.|||||<|0.0001||||||If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|ANCOVA|2 sided t-test with treatment as fixed factor and baseline as covariate.||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0001
71808410|NCT03565887|143118790|SUPERIORITY|If both primary endpoints (LPFT) are significant at 0.05 significance level, then the secondary efficacy endpoints (MRD) were also tested sequentially. Testing stopped if a P≥ 0.05 for a comparison.|||||<|0.0151|||||||ANCOVA|||A two group t-test with a 0.05 two-sided significance level had 90% power to detect a difference in LPFT means of 3.50 assuming that the common standard deviation was 6.0, when the sample sizes in the 2 groups were 94 and 47, respectively (a total sample size of 141).||||<0.0151
71808411|NCT01994954|143118797|SUPERIORITY||||||<|0.03||||||A two-sided P-value of 0.05 or less was interpreted as a statistically significant result.|t-test, 2 sided|||The trial was designed to have 97% power at a type I error rate of 5% to detect a 25% intervention effect with respect to the primary outcome. this was done using an independent sample t-test. P-value was calculated, and a p-value of 0.05 or less was interpreted as statistically significant result.||||<0.03
71808412|NCT01994954|143118798|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Power calculations were based on the primary analysis (t-test comparing changes). A sample size of 130 would have given 80% power, with 0.05 two sided type 1 error rate, to detect a 20% absolute difference in emotional role limitation on the PedsQL v2.0, which we considered to be statistically significant.||||0.38
71808413|NCT00449176|143118802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001||95.0|-1.22|-0.47|||ANCOVA|||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.47|-1.22|<0.001
71808414|NCT02363946|143118925|OTHER||alpha estimate|9.557|STANDARD_ERROR_OF_MEAN|0.037|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370||||
71808415|NCT02363946|143118925|OTHER||beta estimate|1.173|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|1.128|1.218|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|R-square (r\^2)=0.98|1.218|1.128|
71808416|NCT02363946|143118925|OTHER||alpha estimate|9.824|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP||||
71808417|NCT02363946|143118925|OTHER||beta estimate|1.103|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|1.054|1.153|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|R-square (r\^2)=0.98|1.153|1.054|
71808418|NCT02363946|143118927|OTHER||alpha estimate|11.274|STANDARD_ERROR_OF_MEAN|0.057|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370||||
71808419|NCT02363946|143118927|OTHER||beta estimate|1.181|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.112|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.112|
71808420|NCT02363946|143118927|OTHER||alpha estimate|12.133|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP||||
71894913|NCT01165229|143311869|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|-14.56||||0.8324|TWO_SIDED|95.0|-303.3|67.46|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=80YOA Group and Zoster-022 Placebo \>=80YOA Group||67.46|-303.30|0.8324
71808421|NCT02363946|143118927|OTHER||beta estimate|1.147|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|1.08|1.215|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|R-square (r\^2)=0.96|1.215|1.080|
71808422|NCT02363946|143118928|OTHER||alpha estimate|11.286|STANDARD_ERROR_OF_MEAN|0.058|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370||||
71808423|NCT02363946|143118928|OTHER||beta estimate|1.179|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED|95.0|1.11|1.249|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|R-square (r\^2)=0.96|1.249|1.110|
71808424|NCT02363946|143118928|OTHER||alpha estimate|12.347|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED||||||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP||||
71808425|NCT02363946|143118928|OTHER||beta estimate|1.163|STANDARD_ERROR_OF_MEAN|0.049|||TWO_SIDED|95.0|1.081|1.245|||||Estimation of model: Parameter = alpha \* Dose\^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|R-square (r\^2)=0.95|1.245|1.081|
71808426|NCT01967732|143118937|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|77.43|||||TWO_SIDED|95.0|62.69|95.63|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||95.63|62.69|
71808427|NCT01967732|143118938|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|74.47|||||TWO_SIDED|95.0|61.52|90.14|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||90.14|61.52|
71808428|NCT01292239|143118953|SUPERIORITY_OR_OTHER||(see comment)|27.5|||<|0.0001|TWO_SIDED|95.0|14.38|40.56||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||40.56|14.38|<0.0001
71808429|NCT01292239|143118954|SUPERIORITY_OR_OTHER||(see comment)|32.6|||<|0.0001|TWO_SIDED|95.0|19.75|45.4||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.|||45.40|19.75|<0.0001
71808430|NCT01988779|143118977|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.505|||||||ANOVA|||||||0.505
71808431|NCT01988779|143118979|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.39|||||||ANOVA|||||||0.390
71808432|NCT01988779|143118980|NON_INFERIORITY|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.036|||||||ANOVA|||||||0.036
71808433|NCT00584727|143118982|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20||||<0.0001
71808434|NCT00584727|143118983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7155|STANDARD_ERROR_OF_MEAN|0.1334||||95.0|0.3625|0.7155|||Mixed Models Analysis||Mean difference was senofilcon A toric minus etafilcon A sphere.|Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||0.7155|0.3625|
71808435|NCT00584727|143118984|SUPERIORITY_OR_OTHER|||||||0.2161||95.0|||||Chi-squared|||Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.||||0.2161
71808436|NCT00584727|143118985|SUPERIORITY_OR_OTHER|||||||0.1328||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees||||0.1328
71808437|NCT00584727|143118986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.489|STANDARD_ERROR_OF_MEAN|0.1393||||95.0|0.1529|0.489|||Mixed Models Analysis||Mean difference was senofilcon A toric minus alphafilcon A toric|Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.||0.4890|0.1529|
71808438|NCT00584727|143118987|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.||||<0.0001
71808439|NCT00377403|143118990|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The a priori threshold for statistical significnace was p less than or equal to 0.05|ANOVA|Adjusted for disease severity at baseline||We used analysis of variance, controlling for disease severity at baseline to test the null hypothesis that there was no difference between study groups at this point in time.||||0.83
71808440|NCT04171102|143119021|OTHER|||||||0.028||||||\<0.05|t-test, 2 sided|||||||0.028
71808441|NCT01712009|143119029|SUPERIORITY_OR_OTHER||Difference|-6.3|||||TWO_SIDED|95.0|-16.7|4.1|||||Naproxen minus No Prophylaxis|||4.1|-16.7|
71808442|NCT01712009|143119029|SUPERIORITY_OR_OTHER||Difference|-4.1|||||TWO_SIDED|95.0|-14.5|6.3|||||Loratadine minus No Prophylaxis|||6.3|-14.5|
71808443|NCT01712009|143119029|SUPERIORITY_OR_OTHER||Difference|2.2|||||TWO_SIDED|95.0|-8.0|12.4|||||Loratadine minus Naproxen|||12.4|-8.0|
71808444|NCT01712009|143119030|SUPERIORITY_OR_OTHER||Difference|-4.2|||||TWO_SIDED|95.0|-14.4|6.0|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||6.0|-14.4|
71808445|NCT01712009|143119030|SUPERIORITY_OR_OTHER||Difference|-2.4|||||TWO_SIDED|95.0|-12.5|7.8|||||Loratadine minus No Prophylaxis|Difference across all treatment cyces||7.8|-12.5|
71808446|NCT01712009|143119030|SUPERIORITY_OR_OTHER||Difference|1.8|||||TWO_SIDED|95.0|-8.3|12.0|||||Loratadine minus Naproxen|Dfference across all treatment cycles||12.0|-8.3|
71808447|NCT01712009|143119031|SUPERIORITY_OR_OTHER||Difference|-1.7|||||TWO_SIDED|95.0|-6.5|3.2|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles||3.2|-6.5|
71808448|NCT01712009|143119031|SUPERIORITY_OR_OTHER||Difference|-1.3|||||TWO_SIDED|95.0|-6.1|3.6|||||Loratadine minus No Prophylaxis|Difference across all cycles||3.6|-6.1|
71808449|NCT01712009|143119031|SUPERIORITY_OR_OTHER||Difference|0.4|||||TWO_SIDED|95.0|-4.1|4.9|||||Loratadine minus Naproxen|Difference across all cycles||4.9|-4.1|
71808450|NCT01712009|143119032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0881|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.0|-0.7|0.0881
71808451|NCT01712009|143119032|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_DEVIATION|0.2||0.0443|TWO_SIDED|95.0|-0.7|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-0.7|0.0443
71808452|NCT01712009|143119032|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8007|TWO_SIDED|95.0|-0.4|0.3|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.3|-0.4|0.8007
71808453|NCT01712009|143119033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1466|TWO_SIDED|95.0|-1.1|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-1.1|0.1466
71808454|NCT01712009|143119033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0411|TWO_SIDED|95.0|-1.3|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.0|-1.3|0.0411
71808455|NCT01712009|143119033|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5689|TWO_SIDED|95.0|-0.8|0.5|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles||0.5|-0.8|0.5689
71808456|NCT01712009|143119034|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.0775||95.0|-3.0|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles||0.2|-3.0|0.0775
71808457|NCT01712009|143119034|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.8||0.0329|TWO_SIDED|95.0|-3.1|-0.1|||ANCOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles||-0.1|-3.1|0.0329
71843171|NCT03868930|143199390|SUPERIORITY|||||||0.014||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0140
71843172|NCT03868930|143199390|SUPERIORITY|||||||0.1548||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.1548
71808458|NCT01712009|143119034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.7572|TWO_SIDED|95.0|-1.7|1.2|||ANOVA||Loratadine minus Naproxen|Difference across all treatment groups||1.2|-1.7|0.7572
71808459|NCT01751126|143119037|SUPERIORITY||LS Mean|0.76||||0.007|TWO_SIDED|95.0|0.26|1.27||ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).|t-test, 2 sided|||||1.27|0.26|0.007
71808460|NCT01751126|143119037|SUPERIORITY||LS Mean|0.67||||0.01|TWO_SIDED|95.0|0.16|1.18|||ANCOVA|ANCOVA with treatment as well as the baseline CFS and the exposure to Vernal keratoconjunctivitis (VKC) seasons (Hochberg procedure).||||1.18|0.16|0.010
71808461|NCT00785291|143119077|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.2||||0.054|TWO_SIDED|95.0|1.0|1.45||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.45|1.00|0.054
71808462|NCT00785291|143119077|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.55|||<|0.0001|TWO_SIDED|95.0|1.28|1.87||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.||1.87|1.28|<0.0001
71808463|NCT00785291|143119081|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17||||0.2|TWO_SIDED|95.0|0.92|1.47||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.47|0.92|0.20
71808464|NCT00785291|143119081|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.28||||0.038|TWO_SIDED|95.0|1.01|1.61||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank|||||1.61|1.01|0.038
71808465|NCT00844857|143119082|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05. Mixed Model Repeated Measures Analysis (MMRM) terms included baseline, country, treatment, visit, and treatment \* visit interaction.|Mixed Models Analysis|||"Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.~A conservative estimate of effect size of 0.4 was used in the sample size estimation for this study. A randomized ratio of 2:1 provided a 90% power with an effect size of 0.4."||||0.003
71808466|NCT00844857|143119083|SUPERIORITY_OR_OTHER|||||||0.035||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.035
71808467|NCT00844857|143119084|SUPERIORITY_OR_OTHER|||||||0.003||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.003
71808468|NCT00844857|143119085|SUPERIORITY_OR_OTHER|||||||0.007||||||The a priori threshold for statistical significance was 0.05. Ordinal Logistic Regression Model terms include baseline CDRS-R, baseline YMRS, and treatment.|Ordinal Logistic Regression|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.007
71808469|NCT00844857|143119086|SUPERIORITY_OR_OTHER|||||||0.527||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction.|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.527
71808470|NCT00844857|143119087|SUPERIORITY_OR_OTHER|||||||0.03||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment\*visit interaction|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.||||0.030
71808471|NCT00844857|143119088|SUPERIORITY_OR_OTHER|||||||0.002||||||The a priori threshold for statistical significance was 0.05. ANCOVA (analysis of covariance) Model terms included baseline, country, and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.002
71808472|NCT00844857|143119089|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
71808473|NCT00844857|143119090|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
71808474|NCT00844857|143119090|SUPERIORITY_OR_OTHER|||||||0.667||||||P-value for Suicidal Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.667
71808475|NCT00844857|143119090|SUPERIORITY_OR_OTHER|||||||0.309||||||P-value for Suicidal Ideation or Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||0.309
71808476|NCT00844857|143119091|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
71808477|NCT00844857|143119092|SUPERIORITY_OR_OTHER|||||||0.545||||||P-value for ADHDRS-IV-PI Total Score. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.545
71843173|NCT03868930|143199390|SUPERIORITY|||||||0.0302||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0302
71843174|NCT03868930|143199390|SUPERIORITY|||||||0.0158||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0158
71808478|NCT00844857|143119093|SUPERIORITY_OR_OTHER|||||||0.066||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.066
71808479|NCT00844857|143119094|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
71808480|NCT00844857|143119095|SUPERIORITY_OR_OTHER|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.||||1.00
71808481|NCT00844857|143119096|SUPERIORITY_OR_OTHER|||||||0.05||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.050
71808482|NCT00844857|143119097|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
71808483|NCT00844857|143119098|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for Fasting Glucose. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.980
71808484|NCT00844857|143119098|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Cholesterol. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
71808485|NCT00844857|143119098|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for Fasting Triglycerides. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
71808486|NCT00844857|143119099|SUPERIORITY_OR_OTHER|||||||0.005||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||0.005
71843175|NCT03868930|143199390|SUPERIORITY|||||||0.0034||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0034
71843176|NCT03868930|143199390|SUPERIORITY|||||||0.8776||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Post-Treatment (T2) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.8776
71843177|NCT03868930|143199390|SUPERIORITY|||||||0.0002||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0002
71843178|NCT03868930|143199390|SUPERIORITY|||||||0.0198||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0198
71843179|NCT03868930|143199390|SUPERIORITY|||||||0.0013||||||P-value indicates significance of T-test (α=0.05) for the STEP-Home group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.0013
71843180|NCT03868930|143199390|SUPERIORITY||||||<|0.0001||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy Group from Baseline (T1) to Follow-Up (T3) Trait Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||<.0001
71843181|NCT03868930|143199390|SUPERIORITY|||||||0.0345||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) State Anger.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||.0345
71843182|NCT03868930|143199390|SUPERIORITY|||||||0.5918||||||P-value indicates significance of T-test (α=0.05) for the Present Centered Group Therapy group from Baseline (T1) to Follow-Up (T3) Anger Expression Index.|t-test, 2 sided|||"Hypothesis 1: Participants randomized into the STEP-Home Intervention will show improvement on anger as measured by the State-Trait Anger Expression Inventory (STAXI).~Hypothesis 2: Treatment effects will be maintained at follow-up for both groups"||||0.5918
71843183|NCT05441449|143199403|SUPERIORITY|||||||0.002|||||||ANOVA|||||||0.002
71843184|NCT05441449|143199403|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71843185|NCT05441449|143199403|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71843186|NCT05441449|143199404|SUPERIORITY|||||||0.043|||||||ANOVA|||||||0.043
71894914|NCT01165229|143311869|OTHER|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|49.25||||0.0404|TWO_SIDED|95.0|2.92|73.47|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A \>=70YOA Group and Zoster-022 Placebo \>=70YOA Group||73.47|2.92|0.0404
71894915|NCT01165229|143311878|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.88|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.||100.00|40.88|0.0081
71894916|NCT01165229|143311878|OTHER|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.83|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group||100.00|-442.83|0.5097
71843187|NCT05441449|143199404|SUPERIORITY|||||||0.281|||||||ANOVA|||||||0.281
71843188|NCT05441449|143199404|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71843189|NCT05441449|143199405|SUPERIORITY|||||||0.352|||||||ANOVA|||||||0.352
71843190|NCT05441449|143199405|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
71843191|NCT05441449|143199406|SUPERIORITY|||||||0.374|||||||ANOVA|||||||0.374
71843192|NCT05441449|143199406|SUPERIORITY|||||||0.045|||||||ANOVA|||||||0.045
71843193|NCT05441449|143199406|SUPERIORITY|||||||0.196|||||||ANOVA|||||||0.196
71843194|NCT04227899|143199407|OTHER||||||<|0.0001|||||||One-sided Chi-square test|||||||<0.0001
71843195|NCT04227899|143199408|OTHER|||||||0.0019|||||||Farrington-Manning non-inferiority (NI)|||||||0.0019
71843196|NCT04227899|143199409|OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71843197|NCT04227899|143199410|OTHER|||||||0.0081|||||||One-sided Chi-square test|||||||0.0081
71843198|NCT04664881|143199438|SUPERIORITY|||||||0.71|||||||Chi-squared, Corrected|||||||0.71
71843199|NCT04664881|143199439|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiovascular Death||||0.99
71843200|NCT04664881|143199439|SUPERIORITY|||||||0.36|||||||Chi-squared, Corrected|||Hospitalization for Myocardial Infarction||||0.36
71843201|NCT04664881|143199439|SUPERIORITY|||||||0.13|||||||Chi-squared, Corrected|||Arrhythmias||||0.13
71843202|NCT04664881|143199439|SUPERIORITY|||||||0.99|||||||Chi-squared, Corrected|||Cardiac Arrest||||0.99
71894917|NCT01165229|143311879|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-649.86|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group||100.00|-649.86|1.0000
71894918|NCT01165229|143311879|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|TWO_SIDED|95.0|-3938.7|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group||100.00|-3938.70|1.0000
71894919|NCT01165229|143311879|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|21.6||||1|TWO_SIDED|95.0|-149.41|78.91|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group||78.91|-149.41|1.0000
71843203|NCT04868656|143199446|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.15|TWO_SIDED|95.0|-5.0|0.8|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||0.8|-5.0|0.15
71843204|NCT04868656|143199447|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.34|TWO_SIDED|95.0|-6.0|16.6|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); adjusted length of stay (greater than or equal to 4.7 days versus less than 4.7 days); prior implementation of STRIDE (yes vs. no).||16.6|-6.0|0.34
71843205|NCT04868656|143199448|SUPERIORITY||Odds Ratio (OR)|0.6||||0.23|TWO_SIDED|95.0|0.1|2.5|||Regression, Logistic|||Model includes the arm indicator variable only; model does not include stratification variables due to potential for overfitting.||2.5|0.1|0.23
71843206|NCT04955431|143199471|OTHER|We performed a 2-way Repeated Measures ANOVA to compare changes in blood IL-6 levels from baseline to post simulated firefighting on control days (Normal Sleep) and experimental days (Sleep Restriction).|||||<|0.05|||||||ANOVA|||||||<0.05
71894920|NCT01165229|143311879|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|-223.81||||0.1528|TWO_SIDED|95.0|-883.05|18.84|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=80 YOA Group versus Zoster-022/006 Pooled Placebo\>=80 YOA Group||18.84|-883.05|0.1528
71894921|NCT01165229|143311879|OTHER|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|0.29||||0.5417|TWO_SIDED|95.0|-161.53|65.57|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A \>=50 YOA Group versus Zoster-022/006 Pooled Placebo \>=50 YOA Group||65.57|-161.53|0.5417
71843207|NCT04955431|143199472|OTHER|RM-ANOVA|||||>|0.05|||||||ANOVA|||||||>0.05
71843208|NCT04319887|143199489|OTHER||||||||||||||||||statistical analysis section may be deleted|||
71843209|NCT02951052|143199496|NON_INFERIORITY|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA's snapshot algorithm for assessing HIV-1 RNA \>=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB - current ART) is not more than 6%.|Adjusted difference in proportion|0.6|||||TWO_SIDED|95.0|-1.2|2.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||2.5|-1.2|
71677348|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.168|||||TWO_SIDED|95.0|0.881|1.547||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.547|0.881|
71843210|NCT02951052|143199497|NON_INFERIORITY|Non-inferiority in the proportion of participants with HIV-1 RNA\<50 c/mL at Week 48 (per FDA's snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB - current ART) is more than -10%.|Adjusted difference in proportion|-3.0|||||TWO_SIDED|95.0|-6.7|0.7|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).|||0.7|-6.7|
71843211|NCT02951052|143199571|OTHER||Adjusted difference|-0.1||||0.944|TWO_SIDED|95.0|-2.4|2.2|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||2.2|-2.4|0.944
71843212|NCT02951052|143199571|OTHER||Adjusted difference|1.0||||0.385|TWO_SIDED|95.0|-1.3|3.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||3.4|-1.3|0.385
71843213|NCT02951052|143199572|OTHER||Adjusted difference|4.9|||<|0.001|TWO_SIDED|95.0|2.8|7.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||7.1|2.8|<0.001
71843214|NCT02951052|143199572|OTHER||Adjusted difference|6.4|||<|0.001|TWO_SIDED|95.0|4.0|8.8|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||8.8|4.0|<0.001
71843215|NCT02951052|143199573|OTHER||Adjusted difference|5.3||||0.008|TWO_SIDED|95.0|1.4|9.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||9.1|1.4|0.008
71843216|NCT02951052|143199573|OTHER||Adjusted difference|2.0||||0.347|TWO_SIDED|95.0|-2.2|6.2|||ANCOVA||||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|6.2|-2.2|0.347
71894922|NCT01165229|143311880|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|23.75||||0.2885|TWO_SIDED|95.0|-25.8|53.78|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group||53.78|-25.80|0.2885
71808487|NCT00844857|143119100|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
71808488|NCT00844857|143119101|SUPERIORITY_OR_OTHER||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.||||<0.001
71808489|NCT00570674|143119108|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
71808490|NCT00570674|143119109|OTHER||||||<|0.01|||||||Sign test|||||||<0.01
71808491|NCT00570674|143119110|OTHER|||||||0.52|||||||Sign test|||||||0.52
71808492|NCT00570674|143119111|OTHER|||||||0.39|||||||Sign test|||||||0.39
71808493|NCT05183022|143119112|SUPERIORITY|||||||0.07|||||||ANOVA|||||||0.07
71808494|NCT01466985|143119146|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|Least squares (LS) mean difference|-1.37|||<|0.001||90.0|-1.6|-1.02|||ANCOVA|||||-1.02|-1.60|<0.001
71808495|NCT01466985|143119146|SUPERIORITY|Doravirine was declared superior to placebo when the upper bound of the 90% CI was \<-1.|LS mean difference|-1.26|||<|0.001|TWO_SIDED|90.0|-1.51|-1.02|||ANCOVA|||||-1.02|-1.51|<0.001
71808496|NCT05616962|143119151|SUPERIORITY|||||||0.473|||||||ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||0.473
71808497|NCT05616962|143119152|SUPERIORITY|||||||0.03199|||||||paired t-test|||||||0.03199
71808498|NCT05616962|143119153|SUPERIORITY|||||||0.408|||||||ANCOVA|ANCOVA with baseline value as covariate||||||0.408
71808499|NCT05616962|143119154|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808500|NCT05616962|143119155|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71843217|NCT02951052|143199574|OTHER||Adjusted difference|0.2||||0.344|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA||Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||0.7|-0.2|0.344
71843218|NCT02951052|143199574|OTHER||Adjusted difference|-0.1||||0.785|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA||Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||0.4|-0.6|0.785
71843219|NCT02951052|143199574|OTHER||Adjusted difference|0.676||||0.282|TWO_SIDED|95.0|-0.557|1.909|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.909|-0.557|0.282
71843220|NCT02951052|143199574|OTHER||Adjusted difference|0.635||||0.327|TWO_SIDED|95.0|-0.637|1.907|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.907|-0.637|0.327
71843221|NCT02951052|143199574|OTHER||Adjusted difference|0.697||||0.086|TWO_SIDED|95.0|-0.1|1.494|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||1.494|-0.100|0.086
71894923|NCT01165229|143311880|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|54.93||||0.194|TWO_SIDED|95.0|-50.03|86.46|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=80 YOA Group and Zoster-022/006 pooled Placebo \>=80 YOA Group||86.46|-50.03|0.1940
71843222|NCT02951052|143199574|OTHER||Adjusted difference|0.696||||0.092|TWO_SIDED|95.0|-0.113|1.505|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||1.505|-0.113|0.092
71843223|NCT02951052|143199577|OTHER||Adjusted difference|7.9|||<|0.001|TWO_SIDED|95.0|4.1|11.7|||ANCOVA||Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.|||11.7|4.1|<0.001
71808501|NCT05616962|143119156|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808502|NCT05616962|143119157|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808503|NCT05616962|143119158|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808504|NCT05616962|143119159|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71843224|NCT02951052|143199577|OTHER||Adjusted difference|6.9|||<|0.001|TWO_SIDED|95.0|3.3|10.4|||ANCOVA||Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.|||10.4|3.3|<0.001
71843225|NCT02951052|143199577|OTHER||Adjusted difference|10.7|||<|0.001|TWO_SIDED|95.0|7.1|14.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.|||14.4|7.1|<0.001
71808505|NCT05616962|143119160|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808506|NCT05616962|143119161|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808507|NCT05616962|143119162|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808508|NCT05616962|143119163|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71843226|NCT01046825|143199728|SUPERIORITY|||||||0.555|||||||Log Rank|||||||0.5550
71843227|NCT01046825|143199729|SUPERIORITY|||||||0.3605|||||||Log Rank|||||||0.3605
71843228|NCT01046825|143199730|SUPERIORITY|||||||0.6181|||||||Chi-squared|||||||0.6181
71843229|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.8842|TWO_SIDED|95.0|-7.0|8.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||8|-7|0.8842
71843230|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|18.0|||<|0.0001|TWO_SIDED|95.0|10.0|27.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||27|10|<0.0001
71843231|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|47.0|||<|0.0001||95.0|38.0|56.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||56|38|<0.0001
71843232|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|58.0|||<|0.0001|TWO_SIDED|95.0|46.0|70.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||70|46|<0.0001
71843233|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|59.0|||<|0.0001|TWO_SIDED|95.0|47.0|72.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||72|47|<0.0001
71843234|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|80.0|||<|0.0001|TWO_SIDED|95.0|71.0|89.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||89|71|<0.0001
71843235|NCT00624442|143199738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)"||||<0.0001
71843236|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0||||0.3665|TWO_SIDED|95.0|-1.0|2.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||2|-1|0.3665
71843237|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|1.0|||<|0.0357|TWO_SIDED|95.0|0.0|3.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||3|0|<0.0357
71843238|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0004|TWO_SIDED|95.0|1.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|1|0.0004
71808509|NCT05616962|143119164|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808510|NCT05616962|143119165|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808511|NCT05616962|143119166|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808512|NCT05616962|143119167|SUPERIORITY||||||<|0.001||||||"Reported p-value was calculated, did not attempt to indicate threshold for statistical significance. Significance was evaluated at \<0.05. P-values were reported to the thousandths place and those less than 0.001 were reported as \<0.001."|ANCOVA|Repeated measures ANCOVA with baseline value as covariate including the changes from Baseline to months 1, 2, and 3||||||<0.001
71808513|NCT05616962|143119169|SUPERIORITY|||||||0.00463|||||||paired t-test|||||||0.00463
71808514|NCT05616962|143119170|SUPERIORITY|||||||0.23077|||||||paired t-test|||||||0.23077
71808515|NCT05616962|143119171|SUPERIORITY|||||||0.00849|||||||paired t-test|||||||0.00849
71808516|NCT03148470|143119192|OTHER|||||||0.932||||||This p-value refers to the effect of stimulation (cTBS vs iTBS).|Mixed Models Analysis|||||||0.932
71808517|NCT03148470|143119193|OTHER|||||||0.642|||||||Mixed Models Analysis|||||||0.642
71808518|NCT00483184|143119205|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||ANOVA|||Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.||||0.404
71808519|NCT00558428|143119207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-4.9|-2.38|||ANCOVA|Adjusted for baseline and country effect||||-2.38|-4.90|<0.0001
71808520|NCT00558428|143119207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.92|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001||95.0|-6.18|-3.66|||ANCOVA|Adjusted for baseline and country effect||||-3.66|-6.18|<0.0001
71808521|NCT00558428|143119207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-2.66|-0.14|||ANCOVA|Adjusted for baseline and country effect||||-0.14|-2.66|
71808522|NCT00558428|143119207|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.64||||95.0|-3.93|-1.43|||ANCOVA|Adjusted for baseline and country effect||||-1.43|-3.93|
71808523|NCT05224050|143119231|OTHER|A paired-samples t-test was conducted to examine differences in the DASS-21 total score from baseline to 2-weeks post-quit.|Mean Difference (Final Values)|-2.04|STANDARD_DEVIATION|10.54||0.4|TWO_SIDED|95.0|-6.98|2.89||The threshold for statistical significance was p\<0.05|t-test, 2 sided||Mean difference represents the difference of the mean for the DASS-21 total scores at Baseline and at 2-weeks post-quit. The reported estimated value is based on data from the n=20 who attended their 2-weeks post-quit session|||2.89|-6.98|0.40
71808524|NCT05224050|143119231|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 2-weeks post-quit to 1-month post-quit.|Mean Difference (Final Values)|-2.43|STANDARD_DEVIATION|9.15||0.26|TWO_SIDED|95.0|-6.84|1.98||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 2-weeks post-quit and 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.98|-6.84|0.26
71808525|NCT05224050|143119231|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total scores from 1-month post-quit to 3-month follow up.|Mean Difference (Final Values)|-2.75|STANDARD_DEVIATION|6.49||0.11|TWO_SIDED|95.0|-6.21|0.71||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at 1-month post-quit and 3-month follow up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow up session.|||0.71|-6.21|0.11
71808526|NCT05224050|143119234|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline to Quit Day.|Mean Difference (Final Values)|13.7|STANDARD_DEVIATION|8.63|<|0.001|TWO_SIDED|95.0|9.88|17.53||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Baseline to Quit Date. The reported estimated value is based on data from the n=22 participants who attended their Quit Date session.|||17.53|9.88|<0.001
71808527|NCT05224050|143119234|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from Quit Date to 2-weeks Post-Quit.|Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|2.02||0.8|TWO_SIDED|95.0|-0.83|1.06||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from Quit Date to 2-weeks Post-Quit. The reported estimated value is based on data from the n=20 participants who attended their 2-weeks post-quit session.|||1.06|-0.83|0.80
71808528|NCT05224050|143119234|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 2-weeks post-quit to 1=month post-quit.|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|2.97||0.97|TWO_SIDED|95.0|-1.41|1.45||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 2-weeks post-quit to 1-month post-quit. The reported estimated value is based on data from the n=19 participants who attended their 1-month post-quit session.|||1.45|-1.41|0.97
71894924|NCT01165229|143311880|OTHER|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|30.48||||0.1243|TWO_SIDED|95.0|-10.52|56.27|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A \>=70 YOA Group and Zoster-022/006 pooled Placebo\>=70 YOA Group||56.27|-10.52|0.1243
71894925|NCT05370157|143311904|SUPERIORITY||Mean Difference (Net)|4.25|STANDARD_ERROR_OF_MEAN|0.85||0.03|TWO_SIDED|95.0|0.76|7.74|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in knowledge from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||7.74|0.76|.03
71894926|NCT05370157|143311905|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3|TWO_SIDED|95.0|-0.4|0.2|||Regression, Linear|Satterthwaite Approximation||Intent-to-treat analyses tested changes in skill use from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.20|-0.40|.30
71894927|NCT05370157|143311909|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.45|TWO_SIDED|95.0|-1.25|0.79|||Regression, Linear|||Intent-to-treat analyses tested changes in psychological safety from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.79|-1.25|.45
71894928|NCT05370157|143311910|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.89|TWO_SIDED|95.0|-0.44|0.4|||Regression, Linear|||Intent-to-treat analyses tested changes in learning behavior from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||0.40|-0.44|.89
71808529|NCT05224050|143119234|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from 1-month post-quit to 3-month follow-up.|Mean Difference (Final Values)|-2.17|STANDARD_DEVIATION|3.75||0.04|TWO_SIDED|95.0|-4.17|-0.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the average difference in cigarettes smoked per day from 1-month post-quit to 3-month follow-up. The reported estimated value is based on data from the n=16 participants who attended their 3-month follow-up session.|||-0.17|-4.17|0.04
71808530|NCT01627327|143119237|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.022||||0.201|TWO_SIDED|95.0|-0.012|0.055|||ANCOVA|||||0.055|-0.012|0.201
71808531|NCT01175850|143119241|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Z-test|Z-test of two proportions was used to compare treatment groups for all randomized subjects.||||||<0.001
71808532|NCT01175850|143119242|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71808533|NCT01175850|143119243|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71808534|NCT01175850|143119244|SUPERIORITY_OR_OTHER|||||||0.926|TWO_SIDED||||||Chi-squared|||||||0.926
71808535|NCT01175850|143119245|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71808536|NCT01175850|143119246|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71808537|NCT01175850|143119247|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Chi-squared|||||||0.859
71808538|NCT01175850|143119248|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Chi-squared|||||||>0.999
71808539|NCT01175850|143119249|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED||||||Chi-squared|||||||0.096
71808540|NCT01175850|143119250|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71808541|NCT01175850|143119251|SUPERIORITY_OR_OTHER|||||||0.121|TWO_SIDED||||||Chi-squared|||||||0.121
71808542|NCT01175850|143119252|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
71808543|NCT01175850|143119253|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71808544|NCT01175850|143119254|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Chi-squared|||||||0.095
71808545|NCT01175850|143119255|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Chi-squared|||||||0.590
71808546|NCT01175850|143119256|SUPERIORITY_OR_OTHER|||||||0.302|TWO_SIDED||||||Chi-squared|||||||0.302
71808547|NCT01175850|143119257|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED||||||Chi-squared|||||||0.111
71808548|NCT01175850|143119258|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Chi-squared|||||||0.103
71808549|NCT01175850|143119259|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
71808550|NCT03901326|143119281|OTHER|||||||0.05|||||||Chi-squared|||Rate of ICA without obstructive CAD or intervention within 90 days||||0.05
71808551|NCT03901326|143119281|OTHER||||||<|0.001|||||||Chi-squared|||Rate of patients underwent revascularization||||<0.001
71808552|NCT03901326|143119282|OTHER||Hazard Ratio (HR)|0.88||||0.8|TWO_SIDED|95.0|0.59|1.3|||Regression, Cox|||||1.30|0.59|0.80
71808553|NCT03901326|143119283|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71808554|NCT03901326|143119284|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
71808555|NCT01692782|143119286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.7|||||TWO_SIDED||||||Mixed Models Analysis|||The 4 mg and 8 mg SEP 225289 groups were compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||
71808556|NCT01692782|143119286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38||||0.076|TWO_SIDED||||||Mixed Models Analysis|P-values of SEP 225289 4 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.||The 4 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.076
71808557|NCT01692782|143119286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.88||||0.019|TWO_SIDED|||||p-value of SEP 225289 8 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.|Mixed Models Analysis|||The 8 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.||||0.019
71808558|NCT03945188|143119292|SUPERIORITY||Risk Difference (RD)|19.75|||<|0.001|TWO_SIDED|95.0|12.88|26.63|||Cochran-Mantel-Haenszel|||||26.63|12.88|<0.001
71808559|NCT03945188|143119293|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
71808560|NCT03945188|143119294|SUPERIORITY||Risk Difference (RD)|21.18|||<|0.001|TWO_SIDED|95.0|13.03|29.32|||Cochran-Mantel-Haenszel|||||29.32|13.03|<0.001
71808561|NCT03945188|143119295|SUPERIORITY||Risk Difference (RD)|26.69|||<|0.001|TWO_SIDED|95.0|18.99|34.39|||Cochran-Mantel-Haenszel|||||34.39|18.99|<0.001
71808562|NCT03945188|143119296|SUPERIORITY||Risk Difference (RD)|24.55|||<|0.001|TWO_SIDED|95.0|15.46|33.63|||Cochran-Mantel-Haenszel|||||33.63|15.46|<0.001
71894929|NCT05370157|143311911|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.36||0.85|TWO_SIDED|95.0|-1.51|1.36|||Regression, Linear|||Intent-to-treat analyses tested changes in team performance from baseline to follow-up using linear mixed models. Mixed models analyses were conducted in R using the lme4 package and restricted maximum likelihood estimation (REML). Models included fixed effects of time (baseline vs. follow-up), intervention condition, and their interaction as well as random effects for person and team. We used the clubSandwich package to calculate cluster robust standard errors.||1.36|-1.51|.85
71808563|NCT03945188|143119297|SUPERIORITY||Risk Difference (RD)|24.89|||<|0.001|TWO_SIDED|95.0|16.17|33.6|||Cochran-Mantel-Haenszel|||||33.60|16.17|<0.001
71808564|NCT03945188|143119298|SUPERIORITY||Risk Difference (RD)|16.88|||<|0.001|TWO_SIDED|95.0|10.78|22.98|||Cochran-Mantel-Haenszel|||||22.98|10.78|<0.001
71894930|NCT01144637|143311938|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 2)|1.1012|||||TWO_SIDED|95.0|0.9992|1.2136||||||||1.2136|0.9992|
71808565|NCT03945188|143119299|SUPERIORITY||Risk Difference (RD)|18.39|||<|0.001|TWO_SIDED|95.0|11.39|25.39|||Cochran-Mantel-Haenszel|||||25.39|11.39|<0.001
71808566|NCT03945188|143119300|SUPERIORITY||Risk Difference (RD)|25.39|||<|0.001|TWO_SIDED|95.0|18.42|32.36|||Cochran-Mantel-Haenszel|||||32.36|18.42|<0.001
71808567|NCT03945188|143119301|SUPERIORITY||Risk Difference (RD)|15.84|||<|0.001|TWO_SIDED|95.0|10.66|21.03|||Cochran-Mantel-Haenszel|||||21.03|10.66|<0.001
71808568|NCT03945188|143119302|SUPERIORITY||Risk Difference (RD)|28.27|||<|0.001|TWO_SIDED|95.0|18.51|38.02|||Cochran-Mantel-Haenszel|||||38.02|18.51|<0.001
71808569|NCT03945188|143119303|SUPERIORITY||Risk Difference (RD)|24.93|||<|0.001|TWO_SIDED|95.0|15.79|34.07|||Cochran-Mantel-Haenszel|||||34.07|15.79|<0.001
71808570|NCT03945188|143119304|SUPERIORITY||Risk Difference (RD)|26.16|||<|0.001|TWO_SIDED|95.0|17.48|34.84|||Cochran-Mantel-Haenszel|||||34.84|17.48|<0.001
71808571|NCT03945188|143119305|SUPERIORITY||Risk Difference (RD)|11.32|||<|0.001|TWO_SIDED|95.0|6.49|16.14|||Cochran-Mantel-Haenszel|||||16.14|6.49|<0.001
71808572|NCT03945188|143119306|SUPERIORITY||Risk Difference (RD)|10.23|||<|0.001|TWO_SIDED|95.0|4.73|15.73|||Cochran-Mantel-Haenszel|||||15.73|4.73|<0.001
71808573|NCT03945188|143119307|SUPERIORITY||Risk Difference (RD)|20.39|||<|0.001|TWO_SIDED|95.0|13.79|26.98|||Cochran-Mantel-Haenszel|||||26.98|13.79|<0.001
71808574|NCT03945188|143119308|SUPERIORITY||Risk Difference (RD)|9.16|||<|0.001|TWO_SIDED|95.0|4.93|13.38|||Cochran-Mantel-Haenszel|||||13.38|4.93|<0.001
71808575|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|6.49|||=|0.049|TWO_SIDED|95.0|0.02|12.95|||Cochran-Mantel-Haenszel|||Week 2||12.95|0.02|=0.049
71808576|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|15.03|||<|0.001|TWO_SIDED|95.0|7.32|22.74|||Cochran-Mantel-Haenszel|||Week 4||22.74|7.32|<0.001
71808577|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|16.85|||<|0.001|TWO_SIDED|95.0|8.06|25.63|||Cochran-Mantel-Haenszel|||Week 8||25.63|8.06|<0.001
71808578|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|21.66|||<|0.001|TWO_SIDED|95.0|12.71|30.61|||Cochran-Mantel-Haenszel|||Week 16||30.61|12.71|<0.001
71808579|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|23.74|||<|0.001|TWO_SIDED|95.0|14.98|32.51|||Cochran-Mantel-Haenszel|||Week 20||32.51|14.98|<0.001
71808580|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|21.04|||<|0.001|TWO_SIDED|95.0|11.83|30.24|||Cochran-Mantel-Haenszel|||Week 24||30.24|11.83|<0.001
71808581|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|25.82|||<|0.001|TWO_SIDED|95.0|17.08|34.56|||Cochran-Mantel-Haenszel|||Week 32||34.56|17.08|<0.001
71808582|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|23.47|||<|0.001|TWO_SIDED|95.0|14.8|32.14|||Cochran-Mantel-Haenszel|||Week 40||32.14|14.80|<0.001
71808583|NCT03945188|143119309|SUPERIORITY||Risk Difference (RD)|26.37|||<|0.001|TWO_SIDED|95.0|17.92|34.82|||Cochran-Mantel-Haenszel|||Week 48||34.82|17.92|<0.001
71808584|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|3.59|||=|0.057|TWO_SIDED|95.0|-0.11|7.3|||Cochran-Mantel-Haenszel|||Week 2||7.30|-0.11|=0.057
71808585|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|6.88|||=|0.007|TWO_SIDED|95.0|1.86|11.9|||Cochran-Mantel-Haenszel|||Week 4||11.90|1.86|=0.007
71808586|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|10.14|||=|0.001|TWO_SIDED|95.0|4.09|16.2|||Cochran-Mantel-Haenszel|||Week 8||16.20|4.09|=0.001
71808587|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|16.36|||<|0.001|TWO_SIDED|95.0|9.89|22.83|||Cochran-Mantel-Haenszel|||Week 12||22.83|9.89|<0.001
71808588|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|15.37|||<|0.001|TWO_SIDED|95.0|9.23|21.52|||Cochran-Mantel-Haenszel|||Week 16||21.52|9.23|<0.001
71808589|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|17.8|||<|0.001|TWO_SIDED|95.0|11.85|23.75|||Cochran-Mantel-Haenszel|||Week 20||23.75|11.85|<0.001
71808590|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|14.24|||<|0.001|TWO_SIDED|95.0|7.45|21.04|||Cochran-Mantel-Haenszel|||Week 24||21.04|7.45|<0.001
71808591|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|20.03|||<|0.001|TWO_SIDED|95.0|14.25|25.81|||Cochran-Mantel-Haenszel|||Week 32||25.81|14.25|<0.001
71808592|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|15.13|||<|0.001|TWO_SIDED|95.0|8.91|21.35|||Cochran-Mantel-Haenszel|||Week 40||21.35|8.91|<0.001
71808593|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|17.52|||<|0.001|TWO_SIDED|95.0|12.16|22.87|||Cochran-Mantel-Haenszel|||Week 48||22.87|12.16|<0.001
71808594|NCT03945188|143119310|SUPERIORITY||Risk Difference (RD)|19.86|||<|0.001|TWO_SIDED|95.0|13.75|25.98|||Cochran-Mantel-Haenszel|||Week 52||25.98|13.75|<0.001
71808595|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|4.83|||=|0.336|TWO_SIDED|95.0|-5.01|14.68|||Cochran-Mantel-Haenszel|||Week 2||14.68|-5.01|=0.336
71808596|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|17.11|||<|0.001|TWO_SIDED|95.0|7.06|27.15|||Cochran-Mantel-Haenszel|||Week 4||27.15|7.06|<0.001
71808597|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|20.17|||<|0.001|TWO_SIDED|95.0|10.15|30.19|||Cochran-Mantel-Haenszel|||Week 8||30.19|10.15|<0.001
71843239|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|3.0||||0.0086|TWO_SIDED|95.0|1.0|4.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||4|1|0.0086
71843240|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|2.0||||0.032|TWO_SIDED|95.0|0.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||5|0|0.032
71843241|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||LSM placebo corrected diff from baseline|5.0|||<|0.0001|TWO_SIDED|95.0|3.0|6.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean||6|3|<0.0001
71808598|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|23.44|||<|0.001|TWO_SIDED|95.0|13.45|33.43|||Cochran-Mantel-Haenszel|||Week 12||33.43|13.45|<0.001
71808599|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|25.25|||<|0.001|TWO_SIDED|95.0|15.67|34.83|||Cochran-Mantel-Haenszel|||Week 16||34.83|15.67|<0.001
71808600|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|19.77|38.64|||Cochran-Mantel-Haenszel|||Week 20||38.64|19.77|<0.001
71808601|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|26.08|||<|0.001|TWO_SIDED|95.0|16.47|35.69|||Cochran-Mantel-Haenszel|||Week 24||35.69|16.47|<0.001
71808602|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|28.68|||<|0.001|TWO_SIDED|95.0|19.35|38.02|||Cochran-Mantel-Haenszel|||Week 32||38.02|19.35|<0.001
71808603|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|28.43|||<|0.001|TWO_SIDED|95.0|19.3|37.55|||Cochran-Mantel-Haenszel|||Week 40||37.55|19.30|<0.001
71808604|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|29.59|||<|0.001|TWO_SIDED|95.0|20.55|38.64|||Cochran-Mantel-Haenszel|||Week 48||38.64|20.55|<0.001
71808605|NCT03945188|143119311|SUPERIORITY||Risk Difference (RD)|26.43|||<|0.001|TWO_SIDED|95.0|17.18|35.68|||Cochran-Mantel-Haenszel|||Week 52||35.68|17.18|<0.001
71808606|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|5.93|||=|0.24|TWO_SIDED|95.0|-3.96|15.81|||Cochran-Mantel-Haenszel|||Week 2||15.81|-3.96|=0.240
71808607|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|17.5|||<|0.001|TWO_SIDED|95.0|7.48|27.53|||Cochran-Mantel-Haenszel|||Week 4||27.53|7.48|<0.001
71808608|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|20.93|||<|0.001|TWO_SIDED|95.0|10.92|30.94|||Cochran-Mantel-Haenszel|||Week 8||30.94|10.92|<0.001
71808609|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|24.13|||<|0.001|TWO_SIDED|95.0|14.15|34.1|||Cochran-Mantel-Haenszel|||Week 12||34.10|14.15|<0.001
71808610|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|24.51|||<|0.001|TWO_SIDED|95.0|14.89|34.13|||Cochran-Mantel-Haenszel|||Week 16||34.13|14.89|<0.001
71808611|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|29.57|||<|0.001|TWO_SIDED|95.0|20.13|39.01|||Cochran-Mantel-Haenszel|||Week 20||39.01|20.13|<0.001
71808612|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|26.45|||<|0.001|TWO_SIDED|95.0|16.88|36.02|||Cochran-Mantel-Haenszel|||Week 24||36.02|16.88|<0.001
71808613|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|29.35|||<|0.001|TWO_SIDED|95.0|20.01|38.68|||Cochran-Mantel-Haenszel|||Week 32||38.68|20.01|<0.001
71808614|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|28.83|||<|0.001|TWO_SIDED|95.0|19.71|37.95|||Cochran-Mantel-Haenszel|||Week 40||37.95|19.71|<0.001
71808615|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|30.0|||<|0.001|TWO_SIDED|95.0|20.97|39.03|||Cochran-Mantel-Haenszel|||Week 48||39.03|20.97|<0.001
71808616|NCT03945188|143119312|SUPERIORITY||Risk Difference (RD)|26.84|||<|0.001|TWO_SIDED|95.0|17.6|36.07|||Cochran-Mantel-Haenszel|||Week 52||36.07|17.60|<0.001
71808617|NCT03945188|143119313|SUPERIORITY||Risk Difference (RD)|23.05|||<|0.001|TWO_SIDED|95.0|10.2|35.9|||Cochran-Mantel-Haenszel|||||35.90|10.20|<0.001
71808618|NCT03945188|143119314|SUPERIORITY||Risk Difference (RD)|31.86|||<|0.001|TWO_SIDED|95.0|18.45|45.28|||Cochran-Mantel-Haenszel|||||45.28|18.45|<0.001
71808619|NCT02219048|143119317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0719|STANDARD_ERROR_OF_MEAN|0.0909|||TWO_SIDED|90.0|-0.2243|0.0805|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 1||0.0805|-0.2243|
71808620|NCT02219048|143119317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.092|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.2362|0.0523|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 2||0.0523|-0.2362|
71677349|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.88|||||TWO_SIDED|95.0|0.665|1.166||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.166|0.665|
71808621|NCT02219048|143119317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1131|STANDARD_ERROR_OF_MEAN|0.0837|||TWO_SIDED|90.0|-0.2536|0.0274|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 3||0.0274|-0.2536|
71808622|NCT02219048|143119317|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.058|STANDARD_ERROR_OF_MEAN|0.0829|||TWO_SIDED|90.0|-0.1971|0.0812|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline at Week 4||0.0812|-0.1971|
71808623|NCT02219048|143119317|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.0837|STANDARD_ERROR_OF_MEAN|0.0742|||TWO_SIDED|90.0|-0.2081|0.0406|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Over Week 1 to 4||0.0406|-0.2081|
71808624|NCT02219048|143119320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|90.0|-0.285|0.106|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Change From Baseline Averaged Over Week 1 to 4||0.106|-0.285|
71808625|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.017|STANDARD_ERROR_OF_MEAN|10.003|||TWO_SIDED|90.0|-10.76|22.794|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 1||22.794|-10.760|
71808626|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.591|STANDARD_ERROR_OF_MEAN|12.228|||TWO_SIDED|90.0|-13.926|27.108|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 2||27.108|-13.926|
71808627|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.954|STANDARD_ERROR_OF_MEAN|11.673|||TWO_SIDED|90.0|-18.644|20.552|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 3||20.552|-18.644|
71808628|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.368|STANDARD_ERROR_OF_MEAN|12.92|||TWO_SIDED|90.0|-26.069|17.333|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB at Week 4||17.333|-26.069|
71808629|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.299|STANDARD_ERROR_OF_MEAN|10.503|||TWO_SIDED|90.0|-15.323|19.92|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Morning PEF: CFB Averaged Over 4 Weeks||19.920|-15.323|
71808630|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.135|STANDARD_ERROR_OF_MEAN|10.961|||TWO_SIDED|90.0|-17.248|19.519|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 1||19.519|-17.248|
71843242|NCT00624442|143199739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance: p\<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)"||||<0.0001
71843243|NCT00003222|143199761|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.13
71843244|NCT00003222|143199762|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.||||0.004
71843245|NCT04757753|143199763|NON_INFERIORITY|"πN = 2-year successful treatment rate of PA1704 πR = 2-year successful treatment rate of BioRoot™ RCS Δ = πN - πR ΔL = non-inferiority margin fixed to 13% or 0.13~Hypotheses are :~H0 : Δ ≤ -ΔL H1 : Δ \> -ΔL The χ2 of Dunnett \& Gent is used to assess the non-inferiority"|Mean Difference (Final Values)|0.006||||0.03|TWO_SIDED|90.0|-0.0074|0.0087||A priori threshold for statistical significance was \< 0.05|Chi-squared, Corrected|||The statistical analysis was done on the proportion difference of the treatment efficacy, defined on loose criteria, at 24 months, in PP population.||0.0087|-0.0074|0.03
71808631|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.834|STANDARD_ERROR_OF_MEAN|9.956|||TWO_SIDED|90.0|-13.871|19.54|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 2||19.540|-13.871|
71808632|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.374|STANDARD_ERROR_OF_MEAN|11.652|||TWO_SIDED|90.0|-27.933|11.185|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 3||11.185|-27.933|
71808633|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.445|STANDARD_ERROR_OF_MEAN|13.573|||TWO_SIDED|90.0|-23.245|22.356|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB at Week 4||22.356|-23.245|
71808634|NCT02219048|143119322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.212|STANDARD_ERROR_OF_MEAN|10.317|||TWO_SIDED|90.0|-18.52|16.096|||Longitudinal Analysis of Covariance|LANCOVA model contained fixed factors of treatment, week, treatment/baseline by week interaction, baseline value, and unstructured covariance matrix.||Evening PEF: CFB Averaged Over 4 Weeks||16.096|-18.520|
71808635|NCT01618162|143119353|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.02|||<|0.001|TWO_SIDED|95.0|-1.18|-0.87|||ANCOVA|||Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.||-0.87|-1.18|< 0.001
71808636|NCT04124926|143119360|NON_INFERIORITY|The noninferiority of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in EE rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.3|||<|0.0001|TWO_SIDED|95.0|4.49|12.23||2-sided p-value.|Farrington and Manning test||The 2-sided 95% confidence interval (CI) of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||12.23|4.49|<0.0001
71808637|NCT04124926|143119361|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|8.7|||<|0.0001|TWO_SIDED|95.0|1.8|15.53||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||15.53|1.80|<0.0001
71808638|NCT04124926|143119361|NON_INFERIORITY|The noninferiority of each dose group of vonoprazan to lansoprazole was evaluated with a Farrington and Manning test with a noninferiority margin of 10 percentage points for the difference in maintenance of healing rates between treatments (vonoprazan minus lansoprazole).|difference in percentage|7.2|||<|0.0001|TWO_SIDED|95.0|0.21|14.09||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE maintenance rates between each vonoprazan group and lansoprazole group was calculated via the Miettinen and Nurminen method.|||14.09|0.21|<0.0001
71808639|NCT04124926|143119361|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0136||||||2-sided p-value.|Farrington and Manning test|||||||0.0136
71808640|NCT04124926|143119361|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.||||||0.0436||||||2-sided p-value.|Farrington and Manning test|||||||0.0436
71808641|NCT04124926|143119362|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.7|||||TWO_SIDED|95.0|-1.6|7.03|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between vonoprazan 20 mg and lansoprazole 30 mg was calculated from Welch's t-test.|||7.03|-1.60|
71808642|NCT04124926|143119363|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|17.6||||0.0008|TWO_SIDED|95.0|7.44|27.43||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.43|7.44|0.0008
71808643|NCT04124926|143119364|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|2.3||||0.4392|TWO_SIDED|95.0|-3.5|8.04||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in sustained resolution rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||8.04|-3.50|0.4392
71808644|NCT04124926|143119365|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|19.6|||<|0.0001|TWO_SIDED|95.0|11.84|27.58||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||27.58|11.84|<0.0001
71843246|NCT04079517|143199929|NON_INFERIORITY|Comparing mean difference in symptom score (95% confidence intervals). Post hoc analysis. Not powered, but to give an indication of differences between standard dose (20mg) and the non-approved dose (10mg).|Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|||||||Post hoc analysis. Not powered, but to give an indication on differences in symptom score between standard dose (20mg) and the non-approved dose (10mg).||Post hoc analysis. Not powered, but to give an indication on differences between standard dose (20mg) and the non-approved dose (10mg).|||
71843247|NCT04518943|143199975|SUPERIORITY||Mean Difference (Net)|-634.0||||0.418|TWO_SIDED|90.0|-1924.0|655.0|||linear mixed model|||This is the results of financial vs non-financial reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignment, linear week with a spline at week 12, and interactions between factors and weeks.||655|-1924|0.418
71843248|NCT04518943|143199975|SUPERIORITY||Mean Difference (Net)|-1697.0||||0.033|TWO_SIDED|90.0|-3000.0|-385.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-385|-3000|0.033
71808645|NCT04124926|143119366|SUPERIORITY|Observed p-value and not a formal test per the preplanned fixed-sequence testing procedure. The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|6.1||||0.0348|TWO_SIDED|95.0|0.53|11.6||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in EE healing rates between vonoprazan 20 mg and lansoprazole 30 mg was calculated via the Miettinen and Nurminen method.|||11.60|0.53|0.0348
71808646|NCT04124926|143119367|SUPERIORITY|The superiority of the vonoprazan 20 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|15.7||||0.0196|TWO_SIDED|95.0|2.5|28.44||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||28.44|2.50|0.0196
71894931|NCT01144637|143311938|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 3)|0.9444|||||TWO_SIDED|95.0|0.8554|1.0427||||||||1.0427|0.8554|
71894932|NCT01144637|143311938|EQUIVALENCE|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as \[0.5; 2\] for the GMT ratios (pairwise)|GMT ratio (Group 2 / Group 3)|0.8577|||||TWO_SIDED|95.0|0.7753|0.9488||||||||0.9488|0.7753|
71894933|NCT01364467|143311950|OTHER|||||||0.013|||||||t-test, 2 sided|||||||0.013
71894934|NCT01364467|143311951|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||0.98
71894935|NCT01364467|143311951|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||||||0.65
71894936|NCT03842137|143311964|SUPERIORITY||Slope|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.008|TWO_SIDED|95.0|-0.91|-0.15|||Regression, Linear|Utilizing a regression model, baseline craving scores, group condition, and their interaction are regressed on 2-week craving scores.||||-.15|-.91|.008
71894937|NCT03842137|143311965|SUPERIORITY|An ancova model was conducted comparing differences between tDCS and sham on post-stimulation theta burst rate, while controlling for pre-stimulation theta burst rate||||||0.005|||||||ANCOVA|||||||.005
71894938|NCT00780403|143311978|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
71894939|NCT04322708|143311979|SUPERIORITY||Percent Difference from Placebo|81.6|||<|0.0001|TWO_SIDED|95.0|71.5|89.0|||Fisher Exact|||||89.0|71.5|<0.0001
71894940|NCT04322708|143311979|SUPERIORITY||Percent Difference from Placebo|77.0|||<|0.0001|TWO_SIDED|95.0|66.1|85.4|||Fisher Exact|||||85.4|66.1|<0.0001
71894941|NCT04322708|143311980|SUPERIORITY||LSM Difference from Placebo|2.7||||0.247|TWO_SIDED|95.0|-1.9|7.3|||ANCOVA|||||7.3|-1.9|0.2470
71894942|NCT04322708|143311980|SUPERIORITY||LSM Difference from Placebo|-2.8||||0.2372|TWO_SIDED|95.0|-7.3|1.8|||ANCOVA|||||1.8|-7.3|0.2372
71894943|NCT04322708|143311981|SUPERIORITY||LSM Difference from Placebo|-95.7|||<|0.0001|TWO_SIDED|95.0|-109.0|-82.4|||ANCOVA|||||-82.4|-109|<0.0001
71894944|NCT04322708|143311981|SUPERIORITY||LSM Difference from Placebo|-96.2|||<|0.0001|TWO_SIDED|95.0|-110.0|-82.5|||ANCOVA|||||-82.5|-110|<0.0001
71894945|NCT04322708|143311982|SUPERIORITY||Percent Difference from Placebo|83.8|||<|0.0001|TWO_SIDED|95.0|74.4|90.8|||Fisher Exact|||||90.8|74.4|<0.0001
71894946|NCT04322708|143311982|SUPERIORITY||Percent Difference from Placebo|80.3|||<|0.0001|TWO_SIDED|95.0|69.8|87.9|||Fisher Exact|||||87.9|69.8|<0.0001
71894947|NCT04322708|143311983|SUPERIORITY||Percent Difference from Placebo|77.3|||<|0.0001|TWO_SIDED|95.0|66.4|85.5|||Fisher Exact|||||85.5|66.4|<0.0001
71894948|NCT04322708|143311983|SUPERIORITY||Percent Difference from Placebo|72.7|||<|0.0001|TWO_SIDED|95.0|61.3|81.9|||Fisher Exact|||||81.9|61.3|<0.0001
71894949|NCT04322708|143311984|SUPERIORITY||Percent Difference from Placebo|36.5|||<|0.0001|TWO_SIDED|95.0|22.9|49.5|||Fisher Exact|||||49.5|22.9|<0.0001
71894950|NCT04322708|143311984|SUPERIORITY||Percent Difference from Placebo|49.5|||<|0.0001|TWO_SIDED|95.0|35.9|61.0|||Fisher Exact|||||61.0|35.9|<0.0001
71894951|NCT04322708|143311985|SUPERIORITY||Percent Difference from Placebo|-4.8||||0.5561|TWO_SIDED|95.0|-19.2|10.0|||Fisher Exact|||||10.0|-19.2|0.5561
71894952|NCT04322708|143311985|SUPERIORITY||Percent Difference from Placebo|4.9||||0.5554|TWO_SIDED|95.0|-9.9|19.6|||Fisher Exact|||||19.6|-9.9|0.5554
71894953|NCT04322708|143311986|SUPERIORITY||LSM Difference from Placebo|-0.6||||0.9506|TWO_SIDED|95.0|-18.1|17.0|||ANCOVA|||||17.0|-18.1|0.9506
71894954|NCT04322708|143311986|SUPERIORITY||LSM Difference from Placebo|-17.6||||0.0511|TWO_SIDED|95.0|-35.4|0.1|||ANCOVA|||||0.1|-35.4|0.0511
71894955|NCT04322708|143311987|SUPERIORITY||LSM Difference from Placebo|2.6||||0.2007|TWO_SIDED|95.0|-1.4|6.7|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||6.7|-1.4|0.2007
71894956|NCT04322708|143311987|SUPERIORITY||LSM Difference from Placebo|-2.7||||0.1889|TWO_SIDED|95.0|-6.8|1.3|||Mixed Models Analysis|||Weeks 23-24 Change from Baseline||1.3|-6.8|0.1889
71894957|NCT04322708|143311988|SUPERIORITY||LSM Difference from Placebo|-0.3||||0.498|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|||||0.6|-1.3|0.4980
71894958|NCT04322708|143311988|SUPERIORITY||LSM Difference from Placebo|0.2||||0.639|TWO_SIDED|95.0|-0.7|1.2|||ANCOVA|||||1.2|-0.7|0.6390
71894959|NCT03959189|143312032|SUPERIORITY||mixed effects model|-0.0796|STANDARD_ERROR_OF_MEAN|0.2768||0.7746|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following ERX-963 versus placebo. In the primary analysis of SSS, the cohort 1 and cohort 2 data were combined for ERX-963 and placebo treatments.||0.5|-0.6|0.7746
71894960|NCT03959189|143312032|SUPERIORITY||mixed effects model|-0.2608|STANDARD_ERROR_OF_MEAN|0.3589||0.47|TWO_SIDED|95.0|-1.0|0.5|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 1 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 1 mg ERX-963 treatment was compared to the effect of placebo treatment.||0.5|-1.0|0.4700
71843249|NCT04518943|143199975|SUPERIORITY||Mean Difference (Net)|820.0||||0.248|TWO_SIDED|90.0|-347.0|1988.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1988|-347|0.248
71843250|NCT04518943|143199975|SUPERIORITY||Mean Difference (Net)|1121.0||||0.125|TWO_SIDED|90.0|82.0|2323.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 12. It compares change in steps from baseline to week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.|Positive values represent a positive effect of requests for advice on steps compared to no request for advice.|2323|82|0.125
71843251|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.53||0.739|TWO_SIDED|90.0|-1.05|0.7|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.|Positive values represent a positive effect of financial rewards compared to non-financial rewards.|0.70|-1.05|0.739
71843252|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|-0.51||||0.347|TWO_SIDED|90.0|-1.42|0.39|||Mixed Models Analysis||Positive values represent a positive effect of financial rewards compared to non-financial rewards.|This is the results of financial vs non-financial reward factor at week 24. It compares change in efficacy from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.39|-1.42|0.347
71843253|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|0.61||||0.293|TWO_SIDED|90.0|-0.35|1.57|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 12. It compares change in efficacy from baseline to week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.57|-0.35|0.293
71843254|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|0.31||||0.599|TWO_SIDED|90.0|-0.67|1.3|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares efficacy at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.30|-0.67|0.599
71843255|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|1.49||||0.007|TWO_SIDED|90.0|0.58|2.4|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for PC to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.40|0.58|0.007
71843256|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|1.78||||0.002|TWO_SIDED|90.0|0.86|2.7|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.70|0.86|0.002
71843257|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|1.02||||0.068|TWO_SIDED|90.0|0.1|1.94|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares efficacy at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.94|0.10|0.068
71894961|NCT03959189|143312032|SUPERIORITY||mixed effects model|0.1016|STANDARD_ERROR_OF_MEAN|0.4272||0.8127|TWO_SIDED|95.0|-0.8|1.0|||Mixed Models Analysis|||A mixed effects model will be used to compare SSS effects following 2 mg ERX-963 versus placebo. In this analysis of SSS, the effect of 2 mg ERX-963 treatment was compared to the effect of placebo treatment.||1.0|-0.8|0.8127
71894962|NCT01476787|143312104|SUPERIORITY|||||||0.128|||||||Cochran-Mantel-Haenszel|||||||0.128
71894963|NCT01476787|143312105|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.406|TWO_SIDED|95.0|0.756|1.12|||Log Rank|||||1.120|0.756|0.406
71894964|NCT01476787|143312107|SUPERIORITY||Hazard Ratio (HR)|1.038|||||TWO_SIDED|95.0|0.854|1.261||||||||1.261|0.854|
71677350|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.219|||||TWO_SIDED|95.0|2.43|4.264||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.264|2.430|
71843258|NCT04518943|143199976|SUPERIORITY||Mean Difference (Net)|0.19||||0.74|TWO_SIDED|90.0|-0.76|1.14|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.14|-0.76|0.740
71843259|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|0.14||||0.481|TWO_SIDED|90.0|-0.19|0.47|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares intrinsic motivation in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator..||0.47|-0.19|0.481
71843260|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|0.18||||0.388|TWO_SIDED|90.0|-0.16|0.52|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares intrinsic motivation in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.52|-0.16|0.388
71843261|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|-0.02||||0.926|TWO_SIDED|90.0|-0.38|0.34|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.34|-0.38|0.926
71843262|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|-0.17||||0.446|TWO_SIDED|90.0|-0.54|0.2|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.20|-0.54|0.446
71843263|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|0.08||||0.711|TWO_SIDED|90.0|-0.27|0.42|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.42|-0.27|0.711
71843264|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|-0.2||||0.345|TWO_SIDED|90.0|-0.55|0.15|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares efficacy at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.15|-0.55|0.345
71843265|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|0.02||||0.928|TWO_SIDED|90.0|-0.33|0.36|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares intrinsic motivation at week 12 between subjects randomized to receive a request for advice compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.36|-0.33|0.928
71843266|NCT04518943|143199977|SUPERIORITY||Mean Difference (Net)|-0.19||||0.372|TWO_SIDED|90.0|-0.55|0.16|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares intrinsic motivation at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and survey-based outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.16|-0.55|0.372
71843267|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|0.35||||0.767|TWO_SIDED|90.0|-1.6|2.3|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 12. It compares phq8 mental health scores in week 12 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.3|-1.60|0.767
71843268|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|0.78||||0.5|TWO_SIDED|90.0|-1.12|2.69|||Regression, Linear|||This is the results of financial vs non-financial reward factor at week 24. It compares phq8 mental health scores in week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.69|-1.12|0.500
71843269|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|0.59||||0.631|TWO_SIDED|90.0|-1.43|2.61|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||2.61|-1.43|0.631
71894965|NCT01476787|143312108|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.775|1.395||||||||1.395|0.775|
71894966|NCT01476787|143312109|SUPERIORITY||Hazard Ratio (HR)|0.809|||||TWO_SIDED|95.0|0.651|1.006|||Regression, Cox|||||1.006|0.651|
71894967|NCT01662999|143312131|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.943|||||TWO_SIDED|90.0|0.867|1.026|||Mixed Models Analysis|||The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.026|0.867|
71843270|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|-0.62||||0.62|TWO_SIDED|90.0|-2.69|1.44|||Regression, Linear|||This is the results of lottery vs loss-framed reward factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24, and interactions between factors and weeks.||1.44|-2.69|0.620
71843271|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|0.17||||0.886|TWO_SIDED|90.0|-1.77|2.12|||Regression, Linear|||This is the results of pre-commitment (PC) vs no PC factor at week 12. It compares phq8 mental health scores at week 12 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||2.12|-1.77|0.886
71843272|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|-0.07||||0.95|TWO_SIDED|-2.03|-2.03|1.88|||Regression, Linear|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares phq8 mental health scores at week 24 between subjects randomized to receive a request for PC to compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||1.88|-2.03|0.950
71843273|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|-1.45||||0.248|TWO_SIDED|90.0|-3.51|0.61|||Regression, Linear|||This is the results of advice vs no-advice factor at week 12. It compares phq mental health scores at week 12 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.61|-3.51|0.248
71843274|NCT04518943|143199978|SUPERIORITY||Mean Difference (Net)|-1.23||||0.317|TWO_SIDED|90.0|-3.25|0.79|||Regression, Linear|||This is the results of advice vs no-advice factor at week 24. It compares phq mental health scores at week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, indicator for week 12 or 24 week, and interactions between factors and week indicator.||0.79|-3.25|0.317
71843275|NCT04518943|143199979|SUPERIORITY||Mean Difference (Net)|-35.0||||0.972|TWO_SIDED|90.0|-1685.0|1616.0|||Mixed Models Analysis|||This is the results of financial vs non-financial reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive financial rewards compared to those who received nonfinancial rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1616|-1685|0.972
71843276|NCT04518943|143199979|SUPERIORITY||Mean Difference (Net)|-2428.0||||0.019|TWO_SIDED|90.0|-4134.0|-722.0|||Mixed Models Analysis||Positive values represent a positive effect of lottery-based rewards compared to loss-based rewards.|This is the results of lottery vs loss-framed reward factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive lottery-based rewards compared to those who received loss-based rewards. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||-722|-4134|0.019
71843277|NCT04518943|143199979|SUPERIORITY||Mean Difference (Net)|418.0||||0.627|TWO_SIDED|90.0|-999.0|1836.0|||Mixed Models Analysis|||This is the results of precommitment (PC) vs no PC factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for PC compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1836|-999|0.627
71843278|NCT04518943|143199979|SUPERIORITY||Mean Difference (Net)|195.0||||0.842|TWO_SIDED|90.0|-1417.0|1807.0|||Mixed Models Analysis|||This is the results of advice vs no advice factor at week 24. It compares change in steps from baseline to week 24 between subjects randomized to receive a request for advice to other subjects compared to those who received no request. A linear mixed-effect model was estimated with independent variables of demographics, steps and outcomes at baseline, indicators for each of the four factor assignments, linear week with a spline at week 12, and interactions between factors and weeks.||1807|-1417|0.842
71894968|NCT01662999|143312132|SUPERIORITY_OR_OTHER||Ration of adjusted geometric mean|0.984|||||TWO_SIDED|90.0|0.961|1.008|||Mixed Models Analysis|||Treatment B versus C in AUC(INF). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.008|0.961|
71894969|NCT01662999|143312134|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.99|||||TWO_SIDED|90.0|0.966|1.014|||Mixed Models Analysis|||Treatment B versus C in AUC(0-T). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.014|0.966|
71894970|NCT01662999|143312136|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.927|||||TWO_SIDED|90.0|0.883|0.972|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||0.972|0.883|
71843279|NCT02701283|143200089|NON_INFERIORITY|Absolute non-inferiority margin was 0.06|Posterior Median of the Difference|0.999|||||TWO_SIDED|95.0||||The posterior probability of non-inferiority is \> 0.999. The posterior probability is the probability of the event rate by updating the prior probability distribution with observed data at the interim analysis using Bayes' Theorem.|Bayesian||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-4.4%, 0.4%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR system is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months for the Randomized Controlled Trial||||
71843280|NCT01830595|143200110|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71894971|NCT01662999|143312138|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.055|||||TWO_SIDED|90.0|1.004|1.109|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite of saxagliptin). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.109|1.004|
71843281|NCT01830595|143200112|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71843282|NCT01830595|143200113|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
71843283|NCT00391443|143200114|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.211|TWO_SIDED|95.0|0.658|1.097|||Log Rank|||||1.097|0.658|0.2110
71843284|NCT00391443|143200115|SUPERIORITY_OR_OTHER_LEGACY||Relative risk reduction|0.17||||0.2542|TWO_SIDED|95.0|-0.13|0.39|||Fisher Exact|||||0.39|-0.13|0.2542
71843285|NCT00650078|143200137|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.25||||0.001|TWO_SIDED|95.0|1.39|3.64||The p-value was based on logistic regression with treatment, geographic region, gender, and median age class as factors.|Regression, Logistic|||||3.64|1.39|0.0010
71843286|NCT00650078|143200138|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-19.6||||0.0015|TWO_SIDED|95.0|-31.7|-6.1||Wilcoxon Rank Sum Test p-value|Hodges-Lehman method|The difference between the treatment groups was assessed using the median and the 95% CI of the median computed using the Hodges Lehmann method.||||-6.1|-31.7|0.0015
71843287|NCT03213457|143200168|SUPERIORITY||Odds Ratio (OR)|5.51|||<|0.001|TWO_SIDED|95.0|3.711|8.176||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||8.176|3.711|< 0.001
71843288|NCT03213457|143200168|SUPERIORITY||Odds Ratio (OR)|4.33|||<|0.001|TWO_SIDED|95.0|2.968|6.331||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||6.331|2.968|< 0.001
71843289|NCT03213457|143200169|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.275|2.605||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 6||2.605|1.275|< 0.001
71894972|NCT01662999|143312139|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.96|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.960|
71894973|NCT01662999|143312140|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.991|||||TWO_SIDED|90.0|0.961|1.022|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.022|0.961|
71843290|NCT03213457|143200169|SUPERIORITY||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.146|2.326||P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.|Regression, Logistic|||Month 12||2.326|1.146|0.007
71843291|NCT03213457|143200170|SUPERIORITY||Least Squares (LS) Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.094|<|0.001|TWO_SIDED|95.0|-1.18|-0.809||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|mixed model repeated measures (MMRM)|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.809|-1.180|< 0.001
71843292|NCT03213457|143200171|SUPERIORITY||LS Mean of Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.088|<|0.001|TWO_SIDED|95.0|-1.19|-0.845||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.845|-1.190|< 0.001
71894974|NCT01662999|143312141|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
71843293|NCT03213457|143200172|SUPERIORITY||LS Mean of Difference|-0.99|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|-1.156|-0.823||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.823|-1.156|< 0.001
71843294|NCT03213457|143200173|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.073||0.002|TWO_SIDED|95.0|-0.367|-0.08||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.080|-0.367|0.002
71843295|NCT03213457|143200174|SUPERIORITY||LS Mean of Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|-0.329|-0.085||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.085|-0.329|< 0.001
71843296|NCT03213457|143200175|SUPERIORITY||LS Mean of Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.056||0.004|TWO_SIDED|95.0|-0.27|-0.05||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.050|-0.270|0.004
71843297|NCT03213457|143200176|SUPERIORITY||LS Mean of Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.9||0.005|TWO_SIDED|95.0|-4.283|-0.746||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.746|-4.283|0.005
71843298|NCT03213457|143200177|SUPERIORITY||LS Mean of Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.098||0.284|TWO_SIDED|95.0|-0.298|0.088||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.088|-0.298|0.284
71843299|NCT03213457|143200178|SUPERIORITY||LS Mean of Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.092||0.286|TWO_SIDED|95.0|-0.279|0.083||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||0.083|-0.279|0.286
71843300|NCT03213457|143200179|SUPERIORITY||LS Mean of Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.079||0.005|TWO_SIDED|95.0|-0.375|-0.066||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.066|-0.375|0.005
71894975|NCT01662999|143312142|SUPERIORITY_OR_OTHER||ratio of adjusted geometric mean|1.085|||||TWO_SIDED|90.0|1.058|1.113|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.113|1.058|
71843301|NCT03213457|143200180|SUPERIORITY||LS Mean of Difference|-2.49|STANDARD_ERROR_OF_MEAN|1.158||0.032|TWO_SIDED|95.0|-4.773|-0.216||P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.|ANCOVA|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.216|-4.773|0.032
71894976|NCT01662999|143312143|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.994|||||TWO_SIDED|90.0|0.96|1.03|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.030|0.960|
71894977|NCT01662999|143312144|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.046|||||TWO_SIDED|90.0|1.029|1.064|||Mixed Models Analysis|||This analysis assesses the effect of concomitant administration of dapagliflozin on the AUC(0-T) of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.||1.064|1.029|
71894978|NCT03851510|143312163|OTHER|95% confidence of prevalence measure.|prevalence|46.3|||||TWO_SIDED|95.0|32.6|60.4||||||All participants that were consented, eligible, and completed the Vector EFL screening (supine).||60.4|32.6|
71894979|NCT01151137|143312168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.294||||0.0019|TWO_SIDED|95.0|1.337|3.936||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for stroke, systemic arterial embolism, myocardial infarction or cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||3.936|1.337|0.0019
71894980|NCT01151137|143312169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.947|||<|0.0001|TWO_SIDED|95.0|1.448|2.617||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for unscheduled cardiovascular hospitalization or death from any cause~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||2.617|1.448|<0.0001
71894981|NCT01151137|143312171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.115||||0.046|TWO_SIDED|95.0|0.996|4.49||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.||4.490|0.996|0.0460
71894982|NCT03191786|143312203|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.025|TWO_SIDED|95.0|0.63|0.97|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||0.97|0.63|0.025
71894983|NCT03191786|143312204|SUPERIORITY||Difference in OS Rates|6.5|||||TWO_SIDED|95.0|-3.3|16.3||||||OS Rate at 6 Months||16.3|-3.3|
71894984|NCT03191786|143312204|SUPERIORITY||Difference in OS Rates|5.1|||||TWO_SIDED|95.0|-4.9|15.0||||||OS Rate at 12 Months||15.0|-4.9|
71894985|NCT03191786|143312204|SUPERIORITY||Difference in OS Rates|7.4|||||TWO_SIDED|95.0|-1.6|16.5||||||OS Rate at 18 Months||16.5|-1.6|
71894986|NCT03191786|143312204|SUPERIORITY||Difference in OS Rates|11.9|||||TWO_SIDED|95.0|4.4|19.5||||||OS Rate at 24 Months||19.5|4.4|
71894987|NCT03191786|143312206|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.182|TWO_SIDED|95.0|0.7|1.07|||Log Rank|||Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.||1.07|0.70|0.182
71894988|NCT03191786|143312211|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.01||||0.975||95.0|0.57|1.78|||Log Rank|||Time to deterioration for Dyspnoea (single item QLQ-C30)||1.78|0.57|0.975
71894989|NCT03191786|143312211|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.89||||0.62|TWO_SIDED|95.0|0.55|1.42|||Log Rank|||Time to deterioration for Fatigue (multi items QLQ-C30)||1.42|0.55|0.620
71894990|NCT03191786|143312212|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|1.16||||0.653|TWO_SIDED|95.0|0.6|2.26|||Log Rank|||Time to deterioration for Cough (single item QLQ-LC13)||2.26|0.60|0.653
71894991|NCT03191786|143312212|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.51||||0.036|TWO_SIDED|95.0|0.27|0.97|||Log Rank|||Time to deterioration for Chest pain (single item QLQ-LC13)||0.97|0.27|0.036
71894992|NCT03191786|143312212|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.7||||0.125|TWO_SIDED|95.0|0.45|1.11|||Log Rank|||Time to deterioration for Dyspnoea (multiple items QLQ-LC13)||1.11|0.45|0.125
71894993|NCT03191786|143312212|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.75||||0.362|TWO_SIDED|95.0|0.41|1.39|||Log Rank|||Time to deterioration for Arm and/or shoulder pain (single item QLQ-LC13)||1.39|0.41|0.362
71808647|NCT04124926|143119367|SUPERIORITY|The superiority of the vonoprazan 10 mg group to lansoprazole group p-value was evaluated with a Farrington and Manning test with the null hypothesis difference ≤0 versus the alternative hypothesis difference \>0.|difference in percentage|13.3||||0.049|TWO_SIDED|95.0|0.02|26.14||2-sided p-value.|Farrington and Manning test||The 2-sided 95% CI of the difference in maintenance rates between each vonoprazan group and lansoprazole 15 mg group was calculated via the Miettinen and Nurminen method.|||26.14|0.02|0.0490
71808648|NCT04124926|143119368|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.0|||||TWO_SIDED|95.0|-2.63|6.72|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.72|-2.63|
71808649|NCT04124926|143119368|NON_INFERIORITY|If the lower bound of the CI was greater than -15%, noninferiority would be concluded.|difference in mean percentage|2.3|||||TWO_SIDED|95.0|-2.27|6.84|||||The 2-sided 95% CI of the difference in mean percentage of 24-hour heartburn-free days between each vonoprazan group and the lansoprazole group was calculated from Welch's t-test.|||6.84|-2.27|
71808650|NCT03871595|143119369|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.51|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.36|103.83|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||103.83|95.36|
71808651|NCT03871595|143119370|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|70.11|STANDARD_DEVIATION|16.8|||TWO_SIDED|90.0|62.67|78.44|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||78.44|62.67|
71808652|NCT03871595|143119371|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R [%]|99.78|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|95.64|104.11|||||The Adjusted Geometric Mean is adjusted by treatment. The standard deviation is actually the intraindividual geometric Coefficient of Variation \[%\].|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'sequence' (fixed effect), 'subjects within sequences' (random effect), 'period' (fixed effect) and 'treatment' (fixed effect).||104.11|95.64|
71808653|NCT04435366|143119374|SUPERIORITY||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.02||0.0064|TWO_SIDED|95.0|0.016|0.096||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.||0.096|0.016|0.0064
71808654|NCT04435366|143119375|SUPERIORITY||Least Squares Mean Difference|0.362|STANDARD_ERROR_OF_MEAN|0.15||0.0165|TWO_SIDED|95.0|0.066|0.657||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||0.657|0.066|0.0165
71808655|NCT04435366|143119375|SUPERIORITY||Least Squares Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.152||0.0015|TWO_SIDED|95.0|0.189|0.788||Nominal p-value was used for the comparison between avacincaptad pegol and sham versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).||0.788|0.189|0.0015
71808656|NCT04435366|143119376|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.5||0.58|TWO_SIDED|95.0|-3.79|2.12||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||2.12|-3.79|0.58
71808657|NCT04435366|143119377|SUPERIORITY||Least Squares Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|1.68||0.38|TWO_SIDED|95.0|-4.79|1.81||Nominal p-value was used for the comparison between avacincaptad pegol versus sham.|MMRM|||Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).||1.81|-4.79|0.38
71808658|NCT04435366|143119379|SUPERIORITY||Least square mean difference|-0.712|STANDARD_ERROR_OF_MEAN|1.33||0.5929|TWO_SIDED|95.0|-3.326|1.903|||MMRM|||||1.903|-3.326|0.5929
71808659|NCT04435366|143119381|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6424|TWO_SIDED|95.0|0.57|1.42|||Log Rank|||||1.42|0.57|0.6424
71808660|NCT00736645|143119382|OTHER|||||||0.5137|||||||Wilcoxon (Mann-Whitney)|||||||0.5137
71808661|NCT00736645|143119382|OTHER|||||||0.8994|||||||Wilcoxon (Mann-Whitney)|||||||0.8994
71894994|NCT03191786|143312212|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.68||||0.041|TWO_SIDED|95.0|0.46|0.99|||Log Rank|||Time to Confirmed Deterioration for the Composite of the 3 following symptoms: cough, dyspnoea (multi-items QLQ-LC13) and chest pain||0.99|0.46|0.041
71808662|NCT00736645|143119382|OTHER|||||||0.3463|||||||Wilcoxon (Mann-Whitney)|||||||0.3463
71808663|NCT00736645|143119383|OTHER|||||||0.2609|||||||Wilcoxon (Mann-Whitney)|||||||0.2609
71808664|NCT00736645|143119383|OTHER|||||||0.7504|||||||Wilcoxon (Mann-Whitney)|||||||0.7504
71808665|NCT00736645|143119383|OTHER|||||||0.9727|||||||Wilcoxon (Mann-Whitney)|||||||0.9727
71808666|NCT00295022|143119394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|||<|0.001|TWO_SIDED|95.0|-4.35|-1.88|||ANCOVA|||||-1.88|-4.35|<0.001
71808667|NCT00295022|143119394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||=|0.001|TWO_SIDED|95.0|-2.04|0.18|||ANCOVA|||||0.18|-2.04|=0.001
71808668|NCT00295022|143119394|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.19|||<|0.001|TWO_SIDED|95.0|-3.43|-0.95|||ANCOVA|||||-0.95|-3.43|<0.001
71808669|NCT03240692|143119437|OTHER|||||||0.036||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and frontal Default Mode Network (fDMN) functional connectivity||||0.036
71808670|NCT03240692|143119437|OTHER|||||||0.008||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and medial Default Mode Network (mDMN) functional connectivity||||0.008
71894995|NCT03191786|143312213|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.84||||0.272|TWO_SIDED|95.0|0.61|1.15|||Log Rank|||SP263 TC\>=1%||1.15|0.61|0.272
71894996|NCT03191786|143312214|SUPERIORITY|Stratified analysis. Histologic subtype, PD-L1 IHC status and brain metastases (Yes/No) were added as stratification factors.|Hazard Ratio (HR)|0.87||||0.366|TWO_SIDED|95.0|0.64|1.18|||Log Rank|||SP263 TC\>=1%||1.18|0.64|0.366
71894997|NCT03439345|143312215|SUPERIORITY|For the time-to-event analyses, survival analytic methods will be used to evaluate the time to the first event during the entire study period. Cox proportional hazards regression analyses, adjusted for baseline covariates used in minimised randomisation, will be used to estimate the hazard ratios, 95% confidence intervals and corresponding p-values, comparing all participants allocated active fenofibrate with all those allocated placebo.|Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.58|0.91|||Regression, Cox|Adjusted for baseline covariates used in minimised randomisation.||||0.91|0.58|0.006
71808671|NCT03240692|143119437|OTHER|||||||0.06||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and left Default Mode Network (lDMN) functional connectivity.||||0.06
71808672|NCT03240692|143119437|OTHER|||||||0.017||||||False Discovery Corrected (FDR) p value. A p-value of ≤ 0.05 was considered to be statistically significant.|t-test, 2 sided|||Analysis of subgenual Anterior Cingulate Cortex (sgACC) and right Default Mode Network (rDMN) functional connectivity.||||0.017
71808673|NCT02300220|143119439|SUPERIORITY||Cox Proportional Hazard|1.071||||0.764|TWO_SIDED|95.0|0.684|1.676|||Regression, Cox|||The primary endpoint was assessed using a Cox's proportional hazard model with pre-specified adjustment for patient's self-reported history of exacerbations over the previous year and with stratification for study centre. The onset of exacerbation will be monitored up to 90 days or at patient withdrawal.||1.676|0.684|0.764
71808674|NCT02300220|143119440|SUPERIORITY|||||||0.703|||||||Wilcoxon (Mann-Whitney)|||||||0.703
71808675|NCT02300220|143119442|SUPERIORITY|||||||0.239|||||||t-test, 2 sided|||||||0.239
71808676|NCT02238379|143119452|SUPERIORITY_OR_OTHER|||||||0.003||||||Main Effect of Emotion|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.003
71808677|NCT02238379|143119452|SUPERIORITY_OR_OTHER|||||||0.034||||||Main Effect of Face Type|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis||||.034
71808678|NCT02238379|143119452|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Face Type|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
71808679|NCT02238379|143119452|SUPERIORITY_OR_OTHER|||||||0.03||||||Spray Type by Face Type Interaction|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis||||.03
71808680|NCT02238379|143119452|SUPERIORITY_OR_OTHER||||||>|0.22||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||LPP Analysis||||>.22
71808681|NCT02238379|143119453|SUPERIORITY_OR_OTHER||||||>|0.14||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA||N170 Analysis||||>.14
71808682|NCT02238379|143119453|SUPERIORITY_OR_OTHER||||||>|0.17||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||P300 Analysis||||>.17
71808683|NCT02238379|143119453|SUPERIORITY_OR_OTHER||||||>|0.27||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||LPP Analysis||||>.27
71808684|NCT02238379|143119454|SUPERIORITY_OR_OTHER|||||||0.006||||||Main Effect of Emotion|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.006
71808685|NCT02238379|143119454|SUPERIORITY_OR_OTHER|||||||0.01||||||Main Effect of Hemisphere|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170||||.01
71808686|NCT02238379|143119455|SUPERIORITY_OR_OTHER|||||||0.03||||||Main Effect of Spray|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.03
71808687|NCT02238379|143119455|SUPERIORITY_OR_OTHER|||||||0.008||||||Main Effect of Hemisphere|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170||||.008
71808688|NCT02238379|143119456|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
71808689|NCT02238379|143119458|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
71808690|NCT02238379|143119459|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
71808691|NCT02238379|143119460|SUPERIORITY_OR_OTHER|||||||0.05|||||||correlation|||||||.05
71808692|NCT01662882|143119502|SUPERIORITY_OR_OTHER|||||||0.0253||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0253
71808693|NCT01662882|143119502|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0004
71894998|NCT03439345|143312216|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.72||||0.005|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.91|0.57|0.005
71894999|NCT03439345|143312217|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.58||||0.08|TWO_SIDED|95.0|0.31|1.06|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.31|0.08
71895000|NCT03439345|143312218|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74||||0.003|TWO_SIDED|95.0|0.61|0.9|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.90|0.61|0.003
71676199|NCT04075682|142870121|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.67||0.63|TWO_SIDED|95.0|-1.64|0.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||0.99|-1.64|0.63
71843302|NCT03213457|143200181|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.774|-0.508||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.508|-1.774|< 0.001
71895001|NCT03439345|143312219|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.85|0.52|0.001
71895002|NCT03439345|143312220|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.5||||0.008|TWO_SIDED|95.0|0.3|0.84|||Regression, Cox|||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.84|0.30|0.008
71676200|NCT04075682|142870121|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.79|TWO_SIDED|95.0|-1.62|2.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.12|-1.62|0.79
71677351|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.07|||||TWO_SIDED|95.0|0.808|1.417||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.417|0.808|
71895003|NCT03439345|143312221|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline visual acuity.|Mean Difference (Final Values)|0.0||||0.36|TWO_SIDED|95.0|-0.01|0.01|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.01|-0.01|0.36
71895004|NCT03439345|143312222|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline VFQ-25 composite score.|Mean Difference (Final Values)|0.0||||0.58|TWO_SIDED|95.0|-1.0|1.0|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||1|-1|0.58
71895005|NCT03439345|143312223|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Index Score.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.02|0.02|||Regression, Cox|||The estimates were derived from linear mixed model repeated measures.||0.02|-0.02|0.93
71895006|NCT03439345|143312224|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for baseline EQ-5D Visual Analogue Score.|Mean Difference (Final Values)|-1.0||||0.43|TWO_SIDED|95.0|-2.0|1.0|||Regression, Cox|||The estimates were derived from a linear mixed model repeated measures||1|-2|0.43
71895007|NCT03439345|143312225|OTHER||Mean Difference (Final Values)|-254.0|||||TWO_SIDED|95.0|-1062.0|624.0||||||||624|-1062|
71895008|NCT03439345|143312226|OTHER||Incremental cost-effectiveness ratio|614.0|||||TWO_SIDED||||||||£614 cost per QALY gained based on probabilistic analysis|||||
71895009|NCT03439345|143312227|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.58|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.58|
71895010|NCT03439345|143312228|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.4|1.0||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.00|0.40|
71895011|NCT03439345|143312229|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.52|0.97||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.97|0.52|
71676201|NCT04075682|142870121|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.31||0.4491|TWO_SIDED|95.0|-0.84|0.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|These results from the multiple imputation model are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.37|-0.84|0.4491
71808694|NCT01662882|143119502|SUPERIORITY_OR_OTHER|||||||0.4184||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.4184
71895012|NCT03439345|143312230|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.55|1.07||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.07|0.55|
71895013|NCT03439345|143312231|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.21||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.21|0.51|
71808695|NCT01662882|143119502|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.||||0.0008
71895014|NCT03439345|143312232|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.54|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.54|
71895015|NCT03439345|143312233|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.28|0.93||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.93|0.28|
71808696|NCT01662882|143119503|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.||||0.0039
71808697|NCT01662882|143119503|SUPERIORITY_OR_OTHER|||||||0.0357||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0357
71808698|NCT01662882|143119503|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.0010
71808699|NCT01662882|143119503|SUPERIORITY_OR_OTHER|||||||0.2118||95.0|||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR||||0.2118
71808700|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.2968|TWO_SIDED|95.0|-0.18|0.59|||ANCOVA|||||0.59|-0.18|0.2968
71808701|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.186|TWO_SIDED|95.0|-0.64|0.12|||ANCOVA|||||0.12|-0.64|0.1860
71808702|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0027|TWO_SIDED|95.0|-1.03|-0.22|||ANCOVA|||||-0.22|-1.03|0.0027
71808703|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.2766|TWO_SIDED|95.0|-0.62|0.18|||ANCOVA|||||0.18|-0.62|0.2766
71808704|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0057|TWO_SIDED|95.0|-0.94|-0.16|||ANCOVA|||||-0.16|-0.94|0.0057
71808705|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0032|TWO_SIDED|95.0|-0.96|-0.19|||ANCOVA|||||-0.19|-0.96|0.0032
71895016|NCT03439345|143312234|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.6|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.60|
71895017|NCT03439345|143312235|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.49|0.95||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.95|0.49|
71895018|NCT03439345|143312236|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.06||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.06|0.53|
71895019|NCT03439345|143312237|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|1.4|||||TWO_SIDED|95.0|0.55|3.57||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||3.57|0.55|
71895020|NCT03439345|143312238|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.03||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.03|0.48|
71895021|NCT03439345|143312239|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.99||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||0.99|0.56|
71895022|NCT03439345|143312240|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation and for the baseline UACR.|Hazard Ratio (HR)|-12.4|||||TWO_SIDED|95.0|-25.8|3.5|||||Estimates are in %.|Linear mixed model repeated measures analyses were conducted to estimate the trial-averaged percentage difference in geometric mean UACR between the randomised treatment groups. UACR data at baseline was available for 312 participants allocated fenofibrate and 310 participants allocated placebo.||3.5|-25.8|
71808706|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.0786|TWO_SIDED|95.0|-0.72|0.04|||ANCOVA|||||0.04|-0.72|0.0786
71808707|NCT00518115|143119508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0022|TWO_SIDED|95.0|-0.99|-0.22|||ANCOVA|||||-0.22|-0.99|0.0022
71843303|NCT03213457|143200182|SUPERIORITY||LS Mean of Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.303|<|0.001|TWO_SIDED|95.0|-1.978|-0.788||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.788|-1.978|< 0.001
71843304|NCT03213457|143200183|SUPERIORITY||LS Mean of Difference|-1.46|STANDARD_ERROR_OF_MEAN|0.276|<|0.001|TWO_SIDED|95.0|-2.002|-0.915||P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.|MMRM|||Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.||-0.915|-2.002|< 0.001
71895023|NCT03439345|143312241|SUPERIORITY|"Adjusted for baseline covariates used in minimised randomisation.~."|Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.69|1.6||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.60|0.69|
71895024|NCT03439345|143312242|SUPERIORITY|Adjusted for baseline covariates used in minimised randomisation.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.11|1.12||||||Cox proportional hazards regression analyses were used to estimate the hazard ratio and 95% confidence intervals, comparing all participants allocated active fenofibrate with all those allocated placebo.||1.12|0.11|
71808708|NCT04891419|143119527|SUPERIORITY||Rate Difference|91.1|||<|0.0001|TWO_SIDED|95.0|83.7|95.9||P-value is based on the Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||95.9|83.7|<.0001
71895025|NCT05165394|143312245|SUPERIORITY||Least-Squares Mean Treatment Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.5||0.8663|ONE_SIDED|90.0|-8.4|||Significance level = 0.1|ANCOVA||Confidence interval and p-value are one-sided for test of null hypothesis that the LS mean difference between NBI-1065846 and placebo in DARS total score at Day 57 is greater than or equal to zero.||||-8.4|0.8663
71808709|NCT04891419|143119528|SUPERIORITY||Control Difference|54.5|STANDARD_ERROR_OF_MEAN|2.69|<|0.0001|TWO_SIDED|95.0|49.2|59.9||P-value estimated using mixed effects model.|Mixed Models Analysis||95% CI estimated using mixed effects model.|||59.9|49.2|<.0001
71808710|NCT04891419|143119529|SUPERIORITY||Control Difference|42.8|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|37.6|48.0||95% CI and p-value estimated using mixed effects model.|Mixed Models Analysis|||||48.0|37.6|<.0001
71808711|NCT04891419|143119530|SUPERIORITY||Rate Difference|93.1|||<|0.0001|TWO_SIDED|95.0|86.1|97.2||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||97.2|86.1|<.0001
71895026|NCT05165394|143312246|SUPERIORITY||Least-Squares Mean Treatment Difference|-1.1|STANDARD_ERROR_OF_MEAN|3.0||0.7008|TWO_SIDED|95.0|-7.1|4.8|||ANCOVA||NBI-1065846 - Placebo|||4.8|-7.1|0.7008
71808712|NCT04891419|143119531|SUPERIORITY||Rate Difference|92.1|||<|0.0001|TWO_SIDED|95.0|84.9|96.5||P-value is based on Fisher's Exact Test.|Fisher Exact||95% exact unconditional confidence interval for between-group difference in responder rate.|||96.5|84.9|<.0001
71808713|NCT00827918|143119532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.859|TWO_SIDED|95.0|-7.0|5.8|||Difference in the Least Squares Mean|||||5.8|-7.0|0.8590
71808714|NCT00827918|143119532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.2534|TWO_SIDED|95.0|-11.7|3.1|||Difference in the Least Squares Mean|||||3.1|-11.7|0.2534
71808715|NCT00827918|143119535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.4976|TWO_SIDED|95.0|0.62|2.64|||Generalized linear mixed analysis model|||||2.64|0.62|0.4976
71808716|NCT00827918|143119535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0653|TWO_SIDED|95.0|0.95|5.09|||Generalized linear mixed analysis model|||||5.09|0.95|0.0653
71808717|NCT00827918|143119536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8199|TWO_SIDED|95.0|-0.4|0.3|||Constrained longitudinal data analysis|||||0.3|-0.4|0.8199
71895027|NCT05165394|143312247|SUPERIORITY|||||||0.9051|||||||Cochran-Mantel-Haenszel Chi-square test|||CGI-S scores at Day 57 for NBI-1065846 compared to placebo.||||0.9051
71895028|NCT00492622|143312248|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||<|0.01||||||\<0.01 is used for determining the level of significance.|paired t-tests|||||||< 0.01
71895029|NCT00492622|143312249|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||||||||||||||P\<0.05 was used as the level of significance with ANOVA for this endpoint.|||
71895030|NCT00492622|143312250|EQUIVALENCE|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.||||||0.95||||||An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.|ANOVA|||||||0.95
71895031|NCT01332435|143312251|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71895032|NCT01332435|143312251|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Chi-squared|||||||0.0002
71895033|NCT01332435|143312252|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71808718|NCT00827918|143119536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9486|TWO_SIDED|95.0|-0.4|0.4|||Constrained longitudinal data analysis|||||0.4|-0.4|0.9486
71808719|NCT00827918|143119537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9937|TWO_SIDED|95.0|-2.0|2.0|||Constrained longitudinal data analysis|||||2.0|-2.0|0.9937
71808720|NCT00827918|143119537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.2406|TWO_SIDED|95.0|-3.6|0.9|||Constrained longitudinal data analysis|||||0.9|-3.6|0.2406
71808721|NCT00827918|143119538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.5953|TWO_SIDED|95.0|-2.0|1.2|||Constrained longitudinal data analysis|||||1.2|-2.0|0.5953
71808722|NCT00827918|143119538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8567|TWO_SIDED|95.0|-2.0|1.6|||Constrained longitudinal data analysis|||||1.6|-2.0|0.8567
71808723|NCT04154787|143119612|SUPERIORITY|Comparison of adjusted geometric mean ratios on Day 169|Adjusted geometric mean ratio|1.37||||0.267|TWO_SIDED|95.0|0.9|2.08||Calculated at one-sided 10% level from a lower-tailed test|Mixed Models Analysis|||||2.08|0.90|0.2670
71808724|NCT04154787|143119615|SUPERIORITY||Adjusted geometric mean ratios|0.81||||0.4598|TWO_SIDED|95.0|0.47|1.42||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 15||1.42|0.47|0.4598
71808725|NCT04154787|143119615|SUPERIORITY||Geometric mean ratios|1.3||||0.4528|TWO_SIDED|95.0|0.65|2.61||Calculated from a two-sided test at the 0.05 significance level|Mixed Model for Repeated Measures||Comparison of adjusted geometric mean ratios: Test vs Ref.|Day 169||2.61|0.65|0.4528
71895034|NCT01332435|143312252|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Chi-squared|||||||0.0006
71895035|NCT01332435|143312253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71895036|NCT01332435|143312253|SUPERIORITY_OR_OTHER|||||||0.0699||95.0|||||Chi-squared|||||||0.0699
71895037|NCT01332435|143312254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
71895038|NCT01332435|143312254|SUPERIORITY_OR_OTHER|||||||0.8645||95.0|||||Regression, Linear|||||||0.8645
71895039|NCT01332435|143312255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
71895040|NCT01332435|143312255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|||||||<0.001
71895041|NCT02517515|143312257|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment (SVR12) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-naïve group, the sample size 180 treatment-naïve participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
71895042|NCT02517515|143312257|SUPERIORITY|The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
71895043|NCT02517515|143312258|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR24 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||TWO_SIDED|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||99.9|97.0|
71895044|NCT02517515|143312258|SUPERIORITY|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-experienced participants in the double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with SVR24 must exceed 75% to achieve superiority.|percentage of participants|100.0|||||TWO_SIDED|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided \>90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).||100.0|97.4|
71895045|NCT02786537|143312266|SUPERIORITY|Superiority test derived by comparing whether the 95% CI includes zero.|Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-3.6|0.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|PROD vs. SOF/LDV based regimens as reported in PRO (ALL PATIENTS WHO STARTED TREATMENT BY ARM AS TREATED), population limited to as randomization date of the last PrOD patient start date - RBV FREE REGIMENS||0.3|-3.6|
71895046|NCT02786537|143312266|SUPERIORITY||Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method. CI for median derived from PROC QUANTREG.|RBV free EBR/GZR regimen compared to PrOD in consideration that RBV usage was determined by provider and not study randomization.||3.1|-0.4|
71895047|NCT02786537|143312267|SUPERIORITY|Superiority test completed by comparing whether the 95% CI includes zero.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free EBR/GZR regimen vs SOF/LDV (all patients who started treatment by arm as treated)||1.0|-0.6|
71895048|NCT02786537|143312269|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|0.0|1.0|||||The comparisons between regimens can be viewed as superiority test, by comparing whether the 95% CI includes zero|Analysis of EBR/GZR vs. SOF/LDV irrespective of RBV usage in consideration that RBV usage was determined by provider and not study randomization.||1.0|0.0|
71895049|NCT02786537|143312270|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free SOF/LDV vs. PrOD in consideration that RBV usage was determined by provider and not study randomization and limited RBV sample size.||7.0|-4.2|
71895050|NCT02786537|143312270|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero.|Mean Difference (Net)|1.4|||||TWO_SIDED|95.0|-4.2|7.0|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free PrOD vs. SOF/LDV regimens (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||7.0|-4.2|
71895051|NCT02786537|143312271|SUPERIORITY|Superiority test comparison based on whether the 95% CI includes zero|Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-1.6|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. SOF/LDV (all patients who started treatment by arm as treated)||1.3|-1.6|
71895052|NCT02786537|143312274|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-1.9|5.5|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free EBR/GZR vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date). Analysis limited to RBV free regimen in consideration RBV usage determined by provider and not study randomization.||5.5|-1.9|
71895053|NCT02786537|143312274|SUPERIORITY|Superiority test based on whether the 95% CI includes zero|Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.6|2.7|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|RBV free SOF/LDV vs. PrOD regimens as reported in PRO (all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date)||2.7|-4.6|
71676202|NCT04075682|142870121|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.59||0.8713|TWO_SIDED|95.0|-1.26|1.06||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||1.06|-1.26|0.8713
71808726|NCT02586025|143119656|SUPERIORITY||Difference in response rates|17.45||||0.0014|TWO_SIDED|95.0|6.89|28.01||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.01|6.89|0.0014
71808727|NCT02586025|143119657|SUPERIORITY||Difference in response rates|18.36||||0.0008|TWO_SIDED|95.0|7.89|28.83||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||28.83|7.89|0.0008
71808728|NCT02586025|143119658|SUPERIORITY||Difference in response rates|18.37||||0.001|TWO_SIDED|95.0|7.6|29.15||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.15|7.60|0.0010
71843305|NCT04940624|143200184|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-15.64|||=|0.061|TWO_SIDED|95.0|-31.3|0.24||The p-value was calculated by Rank Analysis of Covariance (ANCOVA) model using treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% confidence interval (CI) were based on the Hodges-Lehmann estimation.|||0.24|-31.30|=0.061
71808729|NCT02586025|143119659|SUPERIORITY||Difference in response rates|18.83||||0.0006|TWO_SIDED|95.0|8.14|29.51||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.|||29.51|8.14|0.0006
71808730|NCT02586025|143119661|SUPERIORITY||Difference in response rates|10.4||||0.0125|TWO_SIDED|95.0|1.12|19.69||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||19.69|1.12|0.0125
71808731|NCT02586025|143119662|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.014|TWO_SIDED|95.0|0.32|0.89|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for EFS Event in the Pertuzumab arm vs. Placebo arm||0.89|0.32|0.0140
71808732|NCT02586025|143119662|SUPERIORITY||Difference in EFS Event-Free Rates|-8.16||||0.0062|TWO_SIDED|95.0|-14.0|-2.32|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 1 year||-2.32|-14.00|0.0062
71808733|NCT02586025|143119662|SUPERIORITY||Difference in EFS Event-Free Rates|-9.17||||0.0429|TWO_SIDED|95.0|-18.05|-0.29|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 3 years||-0.29|-18.05|0.0429
71808734|NCT02586025|143119662|SUPERIORITY||Difference in EFS Event-Free Rates|-11.1||||0.0274|TWO_SIDED|95.0|-20.95|-1.24|||Z-test||The difference in EFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in EFS Event-Free Rates at 5 Years||-1.24|-20.95|0.0274
71808735|NCT02586025|143119663|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.014|TWO_SIDED|95.0|0.3|0.88|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for DFS Event in the Pertuzumab arm vs. Placebo arm||0.88|0.30|0.0140
71808736|NCT02586025|143119663|SUPERIORITY||Difference in DFS Event-Free Rates|-5.47||||0.0592|TWO_SIDED|95.0|-11.15|0.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 1 year||0.21|-11.15|0.0592
71808737|NCT02586025|143119663|SUPERIORITY||Difference in DFS Event-Free Rates|-9.0||||0.0426|TWO_SIDED|95.0|-17.69|-0.3|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 3 years||-0.30|-17.69|0.0426
71808738|NCT02586025|143119663|SUPERIORITY||Difference in DFS Event-Free Rates|-10.97||||0.0276|TWO_SIDED|95.0|-20.73|-1.21|||Z-test||The difference in DFS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in DFS Event-Free Rates at 5 years||-1.21|-20.73|0.0276
71808739|NCT02586025|143119664|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.1181|TWO_SIDED|95.0|0.23|1.19|||Stratified log-rank|Two-sided log-rank test used, stratified by disease category (early-stage/locally advanced) \& hormone-receptor status (ER+ \&/or PgR+ or ER- \& PgR-)|The hazard ratio was calculated by stratified Cox proportional hazards model.|Hazard Ratio for OS Event in the Pertuzumab arm vs. Placebo arm||1.19|0.23|0.1181
71843306|NCT04940624|143200185|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-14.29|||=|0.089|TWO_SIDED|95.0|-30.51|1.53||The p-value was calculated by the Rank ANCOVA model using treatment group, age stratum (≤6 years, \>6 years), and rank of baseline seizure frequency per 28 days as predictors.|ANCOVA||The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||1.53|-30.51|=0.089
71843307|NCT04940624|143200186|SUPERIORITY||Odds Ratio (OR)|3.22|||=|0.01|TWO_SIDED|95.0|1.3|7.96|||Cochran-Mantel-Haenszel|The p-value was based on Cochran-Mantel-Haenszel (CMH) test stratified by age stratum (≤6 years, \>6 years).||||7.96|1.30|=0.010
71843308|NCT04940624|143200187|SUPERIORITY||Odds Ratio (OR)|3.59|||=|0.008|TWO_SIDED|95.0|1.36|9.49|||Cochran-Mantel-Haenszel|The p-value was based on CMH test stratified by age stratum (≤6 years, \>6 years).||||9.49|1.36|=0.008
71895054|NCT02786537|143312275|SUPERIORITY|Superiority test comparison based on presence of zero in 95% CI.|Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.4|1.6|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis limited to RBV free regimens in consideration that RBV usage determined by provider and not study randomization. All patients who started treatment by arm as treated.||1.6|-1.4|
71808740|NCT02586025|143119664|SUPERIORITY||Difference in OS Event-Free Rates|0.46||||0.3162|TWO_SIDED|95.0|-0.44|1.36|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 1 year||1.36|-0.44|0.3162
71808741|NCT02586025|143119664|SUPERIORITY||Difference in OS Event-Free Rates|-6.02||||0.0529|TWO_SIDED|95.0|-12.11|0.08|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 3 years||0.08|-12.11|0.0529
71808742|NCT02586025|143119664|SUPERIORITY||Difference in OS Event-Free Rates|-3.89||||0.2616|TWO_SIDED|95.0|-10.69|2.9|||Z-test||The difference in OS event-free rates was calculated as the Placebo arm minus the Pertuzumab arm.|Difference in OS Event-Free Rates at 5 years||2.90|-10.69|0.2616
71808743|NCT02586025|143119670|OTHER||Mean Difference (Final Values)|-0.35|||||TWO_SIDED|95.0|-1.62|0.93|||||Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm|||0.93|-1.62|
71808744|NCT00175825|143119682|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|9.8|||=|0.24|TWO_SIDED|95.0|-7.2|24.0|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||24.0|-7.2|=0.240
71808745|NCT00175825|143119682|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|14.9|||=|0.062|TWO_SIDED|95.0|-0.8|28.2|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||28.2|-0.8|=0.062
71808746|NCT00175825|143119682|SUPERIORITY_OR_OTHER||Percent reduction over Placebo|22.1|||=|0.004|TWO_SIDED|95.0|7.6|34.3|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.||34.3|7.6|=0.004
71808747|NCT00608582|143119683|SUPERIORITY_OR_OTHER||||||<|0.028||||||p\<0.05 considered significant|ANOVA|Post-hoc paired t-tests were performed.||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).||||<0.028
71808748|NCT00608582|143119683|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.||||<0.05
71808749|NCT00608582|143119683|SUPERIORITY_OR_OTHER||||||<|0.237||||||p\<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p\<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.||||<0.237
71808750|NCT00608582|143119684|SUPERIORITY_OR_OTHER|||||||0.414||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||0.414
71808751|NCT00608582|143119684|SUPERIORITY_OR_OTHER||||||<|0.822||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.822
71808752|NCT00608582|143119684|SUPERIORITY_OR_OTHER||||||<|0.835||||||p\<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p\<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).||||<0.835
71808753|NCT03595579|143119688|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71808754|NCT03595579|143119689|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71808755|NCT02450331|143119690|SUPERIORITY||Hazard Ratio (HR)|0.892||||0.2446|TWO_SIDED|95.0|0.735|1.081|||Log Rank|||||1.081|0.735|0.2446
71808756|NCT02450331|143119691|SUPERIORITY||Hazard Ratio (HR)|0.897||||0.3172|TWO_SIDED|95.0|0.726|1.109|||Log Rank|||Stratified analysis based on PDL1 status, tumor stage after resection, and nodal status.||1.109|0.726|0.3172
71808757|NCT02450331|143119692|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.836||||0.2235|TWO_SIDED|95.0|0.626|1.116|||Log Rank|||||1.116|0.626|0.2235
71843309|NCT04940624|143200189|SUPERIORITY||Odds Ratio (OR)|2.51|||=|0.004|TWO_SIDED|95.0|1.33|4.72|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.72|1.33|=0.004
71843310|NCT04940624|143200190|SUPERIORITY||Odds Ratio (OR)|2.58|||=|0.003|TWO_SIDED|95.0|1.37|4.87|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||4.87|1.37|=0.003
71843311|NCT04940624|143200191|SUPERIORITY||Odds Ratio (OR)|1.12|||=|0.741|TWO_SIDED|95.0|0.56|2.26|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Alertness||2.26|0.56|=0.741
71843312|NCT04940624|143200191|SUPERIORITY||Odds Ratio (OR)|1.04|||=|0.901|TWO_SIDED|95.0|0.54|2.02|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Communication||2.02|0.54|=0.901
71843313|NCT04940624|143200191|SUPERIORITY||Odds Ratio (OR)|1.15|||=|0.693|TWO_SIDED|95.0|0.58|2.28|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||Disruptive Behaviors||2.28|0.58|=0.693
71808758|NCT02450331|143119693|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.918||||0.4291|TWO_SIDED|95.0|0.743|1.134|||Log Rank|||||1.134|0.743|0.4291
71808759|NCT02450331|143119694|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.879||||0.1994|TWO_SIDED|95.0|0.722|1.07|||Log Rank|||||1.070|0.722|0.1994
71808760|NCT03232983|143119700|SUPERIORITY||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.992|1.07|||Mixed Models Analysis|||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.07|0.992|
71808761|NCT03232983|143119700|SUPERIORITY||Ratio of Geometric Least Squares Means|1.0|||||TWO_SIDED|90.0|0.962|1.04|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.04|0.962|
71808762|NCT03232983|143119701|SUPERIORITY||Ratio of Geometric LSMeans|1.09|||||TWO_SIDED|90.0|1.0|1.2|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.20|1.00|
71808763|NCT03232983|143119701|SUPERIORITY||Ratio of Geometric LSMeans|1.14|||||TWO_SIDED|90.0|1.04|1.25|||Mixed Models Analysis|||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.||1.25|1.04|
71808764|NCT02606903|143119702|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|110.19|STANDARD_DEVIATION|33.603|||TWO_SIDED|90.0|96.8|125.44|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and body mass index (BMI) group as fixed effects||125.44|96.80|
71808765|NCT02606903|143119703|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.14|STANDARD_DEVIATION|42.354|||TWO_SIDED|90.0|85.15|117.76|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||117.76|85.15|
71895055|NCT02786537|143312278|SUPERIORITY|Superiority test determined by comparing presence of zero in CI.|Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.9|1.3|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method|Analysis based on RBV free regimens -all patients who started treatment by arm as treated, population is limited to as randomization date of the last PrOD patient start date.||1.3|-9.9|
71808766|NCT02606903|143119704|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means (%)|100.22|STANDARD_DEVIATION|53.137|||TWO_SIDED|90.0|82.13|122.29|||ANOVA||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects||122.29|82.13|
71808767|NCT01137474|143119711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.9251||0.001|TWO_SIDED|95.0|-4.87|-1.24||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is \>80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.||-1.24|-4.87|0.0010
71808768|NCT01137474|143119712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.0673|<|0.0001|TWO_SIDED|95.0|-0.59|-0.33||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is \>98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.||-0.33|-0.59|<0.0001
71843314|NCT04940624|143200192|SUPERIORITY||Least Square Mean Difference|-3.03|||=|0.189|TWO_SIDED|95.0|-7.59|1.52||P-value was based on MMRM analysis with change from baseline as outcome and baseline score as fixed continuous effect; treatment group, age stratum, analysis visit, and analysis visit by treatment group interaction as fixed categorical effects.|MMRM|||||1.52|-7.59|=0.189
71843315|NCT04940624|143200193|SUPERIORITY||Odds Ratio (OR)|3.65|||<|0.001|TWO_SIDED|95.0|1.87|7.13|||Cumulative Logit Model|P-value was calculated using the Cumulative Logit model including treatment and age group as factors.||||7.13|1.87|<0.001
71843316|NCT04940624|143200194|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-9.97|||=|0.565|TWO_SIDED|95.0|-29.01|7.87|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||7.87|-29.01|=0.565
71843317|NCT04940624|143200195|SUPERIORITY||Hodges-Lehmann Location Shift Estimate|-8.13|||=|0.637|TWO_SIDED|94.0|-26.31|10.13|||ANCOVA|The Rank ANCOVA model used treatment group, age stratum (≤6 years, \>6 years), and rank of Baseline seizure frequency per 28 days as predictors.|The location shift between soticlestat and placebo (soticlestat - placebo) and its asymptotic 95% CI were based on the Hodges-Lehmann estimation.|||10.13|-26.31|=0.637
71843318|NCT04940624|143200196|SUPERIORITY||Least Square Mean Difference|0.79|||||TWO_SIDED|95.0|-3.81|5.4|||||A linear model with treatment group and age stratum as factors and baseline percentage as a covariate was used for analysis.|||5.40|-3.81|
71843319|NCT04940624|143200197|SUPERIORITY||Least Square Mean Difference|5.6|||||TWO_SIDED|95.0|0.1|11.2||||||||11.2|0.1|
71843320|NCT04940624|143200198|SUPERIORITY||Least Square Mean Difference|-1.1|||||TWO_SIDED|95.0|-3.1|1.0|||||Least square mean difference was estimated using a linear model with treatment group and age stratum as factors.|||1.0|-3.1|
71895056|NCT02786537|143312278|SUPERIORITY|Superiority comparison by viewing presence of zero in CI.|Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-3.4|9.4||||||RBV free regimens as reported in PRO (all patients who started treatment by arm as treated, population limited to as randomization date of the last PrOD patient start date)||9.4|-3.4|
71895057|NCT02786537|143312280|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-3.6|2.1|||||CI for mean derived from PROC TTEST, difference in mean and its 95%CI was calculated by Satterthwaite method.|Analysis based on RBV free regimens in consideration that RBV usage was determined by provider and not study randomization. Population includes patients who started treatment by arm as treated.||2.1|-3.6|
71895058|NCT02786537|143312289|EQUIVALENCE|Pre-specified equivalence range +/-5%|Mean Difference (Net)|-2.3|||||TWO_SIDED|95.0|-15.3|11.3||||||||11.3|-15.3|
71895059|NCT00443560|143312295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.01||95.0|2.3|4.5|||Chi-squared, Corrected|||||4.5|2.3|<0.01
71895060|NCT00443560|143312296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.2|||<|0.01||95.0|9.9|15.0|||Chi-squared, Corrected|||||15.0|9.9|<0.01
71895061|NCT00443560|143312297|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71895062|NCT01009463|143312298|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.06|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.06|0.72|0.181
71895063|NCT01009463|143312298|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.81||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||0.81|0.54|<0.001
71895064|NCT01009463|143312298|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.109|TWO_SIDED|95.0|0.7|1.04|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.04|0.70|0.109
71843321|NCT02382003|143200199|SUPERIORITY||Mean Difference (Net)|10.73||||0.005|TWO_SIDED|||||=Positive\~No-training, 0.030=Positive\~50/50 training, 0.833=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 7.053=Positive\~50/50 training, 0.366=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.005
71843322|NCT02382003|143200199|SUPERIORITY||Mean Difference (Net)|0.449||||0.799|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.799
71843323|NCT02382003|143200199|SUPERIORITY||Mean Difference (Net)|9.085||||0.011|TWO_SIDED|||||=No-train+Neut\~Pos+Anx, 0.026=No-train+Neut\~Pos+Neut, 0.094=No-train+Anx\~Pos+Anx, 0.170=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≥ 0.136|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx, 7.328=No-train+Neut\~Pos+Neut, 4.722=No-train+Anx\~Pos+Anx, 3.547=No-train+Anx\~Pos+Neut, No-train(all)\~50/50(all)≤3.988|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.011
71843324|NCT02382003|143200200|SUPERIORITY||Mean Difference (Net)|11.551||||0.003|TWO_SIDED|||||"=Positive\~No-training, 0.130=Positive\~50/50 training, 0.269=50/50\~No-training~Alpha = .05"|Likelihood Ratio Tests|2=Positive\~No-training, 2=Positive\~50/50 training, 2=50/50\~No-training|=Positive\~No-training, 4.075=Positive\~50/50 training, 2.630=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.003
71843325|NCT02382003|143200200|SUPERIORITY||Mean Difference (Net)|3.933||||0.14|TWO_SIDED|||||Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime||Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.140
71895065|NCT01009463|143312299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.43|TWO_SIDED|95.0|0.76|1.13|||Regression, Cox|||||1.13|0.76|0.430
71895066|NCT01009463|143312299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.59|0.89||Nominal p-value|Regression, Cox|||||0.89|0.59|0.002
71895067|NCT01009463|143312299|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.114|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|||||1.04|0.69|0.114
71895068|NCT01009463|143312300|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.||||1.05|0.67|0.125
71895069|NCT01009463|143312300|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||0.78|0.49|<0.001
71895070|NCT01009463|143312300|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.064|TWO_SIDED|95.0|0.64|1.01|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable||||1.01|0.64|0.064
71895071|NCT01009463|143312301|SUPERIORITY_OR_OTHER||Least squares mean difference|0.041||||0.011|TWO_SIDED|95.0|0.009|0.072||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.072|0.009|0.011
71895072|NCT01009463|143312301|SUPERIORITY_OR_OTHER||Least squares mean difference|0.058|||<|0.001|TWO_SIDED|95.0|0.027|0.09||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.090|0.027|<0.001
71895073|NCT01009463|143312301|SUPERIORITY_OR_OTHER||Least squares mean difference|0.064|||<|0.001|TWO_SIDED|95.0|0.033|0.096||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.096|0.033|<0.001
71895074|NCT01494038|143312302|NON_INFERIORITY|Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.|Incidence rate difference|0.1|||||TWO_SIDED|95.0|-4.77|4.98||||||||4.98|-4.77|
71895075|NCT01494038|143312303|SUPERIORITY|||||||0.093|||||||Fisher Exact|mid-P adjustment||||||0.093
71895076|NCT01494038|143312305|SUPERIORITY|||||||0.288|||||||Fisher Exact|mid-P adjustment||||||0.288
71895077|NCT01494038|143312306|SUPERIORITY|||||||0.073|||||||Fisher Exact|mid-P adjustment||||||0.073
71895078|NCT01494038|143312307|SUPERIORITY|||||||0.264|||||||Fisher Exact|mid-P adjustment||||||0.264
71895079|NCT01494038|143312308|SUPERIORITY|||||||0.012|||||||Fisher Exact|Mid-P adjustment||||||0.012
71895080|NCT01494038|143312311|SUPERIORITY|||||||0.279|||||||Fisher Exact|mid-P adjustment||||||0.279
71895081|NCT01494038|143312312|SUPERIORITY|||||||0.893|||||||Fisher Exact|mid-P adjustment||||||.893
71895082|NCT01494038|143312313|SUPERIORITY||Incidence rate difference|0.01|||||TWO_SIDED|95.0|-0.94|0.96||||||||0.96|-0.94|
71895083|NCT01494038|143312314|SUPERIORITY||Incidence rate difference|0.02|||||TWO_SIDED|95.0|-1.02|1.07||||||||1.07|-1.02|
71895084|NCT01494038|143312315|SUPERIORITY||Incidence rate difference|-1.43|||||TWO_SIDED|95.0|-4.17|1.32||||||||1.32|-4.17|
71895085|NCT01494038|143312316|SUPERIORITY||Incidence rate difference|-0.39|||||TWO_SIDED|95.0|-1.33|0.56||||||||0.56|-1.33|
71895086|NCT01494038|143312317|SUPERIORITY||Incidence rate difference|-0.38|||||TWO_SIDED|95.0|-1.72|0.97||||||||0.97|-1.72|
71676203|NCT04075682|142870121|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.85||0.99|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.66|-1.66|0.99
71676204|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.69|STANDARD_ERROR_OF_MEAN|0.34||0.04|TWO_SIDED|95.0|0.02|1.37||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.37|0.02|0.04
71808769|NCT01137474|143119713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|1.0091||0.0043|TWO_SIDED|95.0|-4.88|-0.91||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|ANCOVA|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||-0.91|-4.88|0.0043
71808770|NCT01137474|143119714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.5811||0.0843|TWO_SIDED|95.0|-2.15|0.14||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.||0.14|-2.15|0.0843
71808771|NCT01137474|143119715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.6866|||TWO_SIDED|95.0|-1.96|0.73||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|ANCOVA|||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.||0.73|-1.96|
71808772|NCT01137474|143119716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.0717|||TWO_SIDED|95.0|-0.46|-0.18||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test not performed since previous tests were not significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.||-0.18|-0.46|
71808773|NCT04794803|143119717|SUPERIORITY||||||=|0.02164|||||||Log Rank|||||||= 0.02164
71808774|NCT04794803|143119717|SUPERIORITY||||||=|0.20043|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: Supplemental oxygen requirement based on PaO2/FiO2||||= 0.20043
71808775|NCT04794803|143119717|SUPERIORITY||||||=|0.30215|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first invasive mechanical ventilation||||= 0.30215
71808776|NCT04794803|143119717|SUPERIORITY|||||||0.5637|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first admission to ICU||||0.56370
71808777|NCT04794803|143119717|SUPERIORITY||||||=|0.00132|||||||Log Rank|||Sensitivity analysis of time to event for each single component of the primary endpoint: time to first use of a rescue medication for any reason||||= 0.00132
71808778|NCT04794803|143119718|SUPERIORITY|||||||0.731|||||||Fisher Exact|||comparison at week 1||||0.731
71808779|NCT04794803|143119718|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOT||||1.000
71808780|NCT04794803|143119718|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
71808781|NCT04794803|143119719|SUPERIORITY|||||||0.353|||||||Fisher Exact|||at baseline||||0.353
71808782|NCT04794803|143119719|SUPERIORITY|||||||0.401|||||||Fisher Exact|||At Day 1||||0.401
71808783|NCT04794803|143119719|SUPERIORITY|||||||0.066|||||||Fisher Exact|||At Day 2||||0.066
71808784|NCT04794803|143119719|SUPERIORITY|||||||0.102|||||||Fisher Exact|||At week 1||||0.102
71808785|NCT04794803|143119719|SUPERIORITY|||||||0.314|||||||Fisher Exact|||at EOT||||0.314
71808786|NCT04794803|143119719|SUPERIORITY|||||||1|||||||Fisher Exact|||at EOS||||1.000
71895087|NCT01494038|143312318|SUPERIORITY||Incidence rate difference|-1.69|||||TWO_SIDED|95.0|-4.48|1.1||||||||1.1|-4.48|
71895088|NCT01494038|143312319|SUPERIORITY||Incidence rate difference|-1.3|||||TWO_SIDED|95.0|-3.86|1.25||||||||1.25|-3.86|
71676205|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.87|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.85|0.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.11|-1.85|0.08
71677352|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.72|||||TWO_SIDED|95.0|0.544|0.954||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.954|0.544|
71808787|NCT04794803|143119720|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||>0.999
71808788|NCT04794803|143119720|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||>0.999
71808789|NCT04794803|143119720|SUPERIORITY|||||||0.05||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.050
71808790|NCT04794803|143119720|SUPERIORITY|||||||0.0227||||||p-values are referred to a two-sided Wilcoxon test for differences in the change of VAS scale.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0227
71808791|NCT04794803|143119721|SUPERIORITY|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||At Day 1||||0.122
71808792|NCT04794803|143119721|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||At Day 2||||0.985
71808793|NCT04794803|143119721|SUPERIORITY|||||||0.857|||||||Wilcoxon (Mann-Whitney)|||at week 1||||0.857
71808794|NCT04794803|143119721|SUPERIORITY|||||||0.436|||||||Wilcoxon (Mann-Whitney)|||at EOT||||0.436
71808795|NCT04794803|143119721|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||At EOS||||0.350
71808796|NCT04794803|143119722|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.596|||||||Fisher Exact|||Day 1||||0.596
71808797|NCT04794803|143119722|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.667|||||||Fisher Exact|||Day 2||||0.667
71808798|NCT04794803|143119722|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.037|||||||Fisher Exact|||Week 1||||0.037
71808799|NCT04794803|143119722|SUPERIORITY|p-values are referred to a two-sided Fisher's Exact test for worsening||||||0.293||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.293
71808800|NCT04794803|143119723|SUPERIORITY|||||||0.539||||||p-values are referred to a two-sided Fisher's Exact test for worsening and|Fisher Exact|||Day 1||||0.539
71895089|NCT01494038|143312320|SUPERIORITY||Incidence rate difference|2.14|||||TWO_SIDED|95.0|-7.86|12.13||||||||12.13|-7.86|
71895090|NCT01494038|143312321|SUPERIORITY||Incidence rate difference|6.89|||||TWO_SIDED|95.0|-0.08|13.86||||||||13.86|-0.08|
71808801|NCT04794803|143119723|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Day 2||||1.000
71808802|NCT04794803|143119723|SUPERIORITY|||||||0.102||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||Week 1||||0.102
71808803|NCT04794803|143119723|SUPERIORITY|||||||0.119||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOT||||0.119
71808804|NCT04794803|143119723|SUPERIORITY|||||||0.515||||||p-values are referred to a two-sided Fisher's Exact test for worsening|Fisher Exact|||EOS||||0.515
71808805|NCT04794803|143119724|SUPERIORITY|||||||0.366||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||Week 1||||0.366
71808806|NCT04794803|143119724|SUPERIORITY|||||||0.489||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOT||||0.489
71808807|NCT04794803|143119724|SUPERIORITY|||||||0.486||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration.|Wilcoxon (Mann-Whitney)|||EOS||||0.486
71808808|NCT04794803|143119725|SUPERIORITY|||||||0.79||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||Week 1||||0.790
71808809|NCT04794803|143119725|SUPERIORITY|||||||0.961||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOT||||0.961
71808810|NCT04794803|143119725|SUPERIORITY|||||||0.619||||||p-values are referred to a two-sided Wilcoxon test for cumulative quantity|Wilcoxon (Mann-Whitney)|||EOS||||0.619
71808811|NCT04794803|143119726|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
71808812|NCT04794803|143119726|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 1||||1.000
71808813|NCT04794803|143119726|SUPERIORITY|||||||0.678||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Day 2||||0.678
71808814|NCT04794803|143119726|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Week 1||||1.000
71808815|NCT04794803|143119726|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
71808816|NCT04794803|143119726|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOS||||1.000
71808817|NCT04794803|143119727|SUPERIORITY|||||||0.696||||||p-values are referred to a two-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||Week 1||||0.696
71808818|NCT04794803|143119727|SUPERIORITY||||||>|0.999||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOT||||>0.999
71808819|NCT04794803|143119727|SUPERIORITY|||||||0.596||||||p-values are referred to a-sided Wilcoxon test for cumulative duration|Wilcoxon (Mann-Whitney)|||EOS||||0.596
71895091|NCT01494038|143312322|SUPERIORITY||Incidence rate difference|5.49|||||TWO_SIDED|95.0|-13.7|24.68||||||||24.68|-13.7|
71895092|NCT01494038|143312323|SUPERIORITY||Incidence rate difference|15.88|||||TWO_SIDED|95.0|2.11|29.65||||||||29.65|2.11|
71895093|NCT01494038|143312324|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
71808820|NCT04794803|143119728|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||Baseline||||1.000
71895094|NCT01494038|143312325|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
71895095|NCT01494038|143312326|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
71808821|NCT04794803|143119728|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 1||||1.000
71808822|NCT04794803|143119728|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||Day 2||||1.000
71808823|NCT04794803|143119728|SUPERIORITY|||||||1|||||||Fisher Exact|p-values are referred to a two-sided Fisher's Exact test for proportion||week 1||||1.000
71808824|NCT04794803|143119728|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Fisher's Exact test for proportion|Fisher Exact|||EOT||||1.000
71808825|NCT04794803|143119730|SUPERIORITY|||||||0.76||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||baseline||||0.760
71808826|NCT04794803|143119730|SUPERIORITY|||||||0.394||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||Week 1||||0.394
71808827|NCT04794803|143119730|SUPERIORITY|||||||0.141||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOT||||0.141
71895096|NCT01494038|143312327|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
71808828|NCT04794803|143119730|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
71895097|NCT01494038|143312328|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
71895098|NCT01494038|143312329|SUPERIORITY||Incidence rate difference|3.38|||||TWO_SIDED|95.0|-1.31|8.07||||||||8.07|-1.31|
71895099|NCT01494038|143312330|SUPERIORITY||Incidence rate difference|-0.82|||||TWO_SIDED|95.0|-4.63|3.0||||||||3|-4.63|
71808829|NCT04794803|143119731|SUPERIORITY|||||||0.5||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||baseline||||0.500
71808830|NCT04794803|143119731|SUPERIORITY|||||||0.112||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||week 1||||0.112
71808831|NCT04794803|143119731|SUPERIORITY|||||||0.277||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOT||||0.277
71808832|NCT04794803|143119731|SUPERIORITY||||||>|0.999||||||p-values are referred to a two-sided Wilcoxon test.|Wilcoxon (Mann-Whitney)|||EOS||||>0.999
71895100|NCT01494038|143312331|SUPERIORITY||Incidence rate difference|3.39|||||TWO_SIDED|95.0|-1.46|8.25||||||||8.25|-1.46|
71895101|NCT01494038|143312336|OTHER|Measuring agreement between the tests|||||<|0.0001|||||||Chi-squared|McNemars test||||||< 0.0001
71895102|NCT01494038|143312336|OTHER|Agreement between tests|Kappa coefficient|0.42|||||TWO_SIDED|95.0|0.35|0.5||||||||0.50|0.35|
71895103|NCT01494038|143312337|OTHER|Agreement between tests||||||0.22|||||||Chi-squared|McNemar's test||||||0.22
71895104|NCT01494038|143312337|OTHER|Agreement between tests|Kappa coefficient|0.11|||||TWO_SIDED|95.0|0.001|0.21||||||||0.21|0.001|
71895105|NCT01494038|143312338|OTHER|Agreement between tests|||||<|0.0001|||||||Chi-squared|McNemar's test||||||< 0.0001
71895106|NCT01494038|143312338|OTHER|Agreement between tests|Kappa coefficient|0.46|||||TWO_SIDED|95.0|0.39|0.53||||||||0.53|0.39|
71895107|NCT00430781|143312342|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.535||90.0|0.65|1.7||Stratified log-rank test with one-sided p-value. p\<=0.0037 required for significance, and p\>0.4956 indicated futility.|Log Rank||The estimated value is the hazard ratio comparing combination to lapatinib monotherapy|||1.7|0.65|0.535
71808833|NCT04794803|143119732|SUPERIORITY|||||||0.2027||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.2027
71808834|NCT04794803|143119732|SUPERIORITY|||||||1||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||1.0000
71808835|NCT04794803|143119732|SUPERIORITY|||||||0.4469||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Week 1 vs baseline||||0.4469
71808836|NCT04794803|143119732|SUPERIORITY|||||||0.2466||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.2466
71808837|NCT04794803|143119732|SUPERIORITY|||||||0.1752||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.1752
71808838|NCT04794803|143119733|SUPERIORITY|||||||0.6441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.6441
71808839|NCT04794803|143119733|SUPERIORITY|||||||0.3529||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3529
71808840|NCT04794803|143119733|SUPERIORITY|||||||0.3581||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.3581
71808841|NCT04794803|143119733|SUPERIORITY|||||||0.1666||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.1666
71808842|NCT04794803|143119733|SUPERIORITY|||||||0.0851||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0851
71808843|NCT04794803|143119734|SUPERIORITY|||||||0.3359||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.3359
71895108|NCT00430781|143312345|SUPERIORITY_OR_OTHER|||||||0.237||95.0||||One-sided p-value.|Fisher Exact|||||||0.237
71895109|NCT00430781|143312349|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.66||||0.013||90.0|0.48|0.91||Stratified log-rank test with one-sided p-value.|Log Rank|||||0.91|0.48|0.013
71895110|NCT05099991|143312350|NON_INFERIORITY|Non-inferiority would be demonstrated with a mean increase in procedure of 5 minutes.|Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.8|8.2||||||||8.2|-7.8|
71895111|NCT05099991|143312351|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
71895112|NCT01389128|143312353|OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
71895113|NCT01389128|143312356|OTHER|||||||0.68|||||||Chi-squared|||||||0.68
71895114|NCT01521845|143312373|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
71895115|NCT01521845|143312374|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71895116|NCT01521845|143312375|SUPERIORITY_OR_OTHER|||||||1||95.0|||||not comparable|||||||1
71895117|NCT01532453|143312376|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED|||||Rank ANCOVA With treatment, center, gender, transplanted organ as factors and age of organ transplant as a covariable.|ANCOVA|||||||0.0278
71808844|NCT04794803|143119734|SUPERIORITY|||||||0.3136||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.3136
71895118|NCT01532453|143312377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579|||<|0.05|TWO_SIDED|95.0|0.2703|1.2405|||ANCOVA|||||1.2405|0.2703|<0.05
71895119|NCT03240081|143312405|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when defining and evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.08|TWO_SIDED|||||Threshold for significance \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.08
71895120|NCT03240081|143312406|NON_INFERIORITY|We set 2 points (20%) as the margin of difference when evaluating non-inferiority in comparing the 2 arms at 4 weeks.|Median Difference (Final Values)|2.0||||0.95|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.95
71808845|NCT04794803|143119734|SUPERIORITY|||||||0.0441||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.0441
71808846|NCT04794803|143119734|SUPERIORITY|||||||0.0965||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.0965
71808847|NCT04794803|143119734|SUPERIORITY|||||||0.0519||||||p-values are referred to a two-sided Wilcoxon test for differences in the change|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.0519
71808848|NCT04794803|143119735|SUPERIORITY|||||||0.47||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 1 vs baseline||||0.470
71808849|NCT04794803|143119735|SUPERIORITY|||||||0.425||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||Day 2 vs baseline||||0.425
71808850|NCT04794803|143119735|SUPERIORITY|||||||0.086||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||week 1 vs baseline||||0.086
71808851|NCT04794803|143119735|SUPERIORITY|||||||0.6||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOT vs baseline||||0.600
71808852|NCT04794803|143119735|SUPERIORITY|||||||0.717||||||p-values are referred to a two-sided Wilcoxon test for differences in the change.|Wilcoxon (Mann-Whitney)|||EOS vs baseline||||0.717
71808853|NCT01570829|143119780|SUPERIORITY|||||||0.0352|||||||Fisher Exact|||||||0.0352
71808854|NCT01570829|143119781|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71808855|NCT01570829|143119782|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71808856|NCT01570829|143119783|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|Breslow-Day test p-value is 0.98||||||0.0001
71808857|NCT01570829|143119784|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
71808858|NCT01570829|143119785|SUPERIORITY|||||||0.0004||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||||||0.0004
71808859|NCT01570829|143119786|SUPERIORITY|||||||0.67||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with waist circumference data.||||0.67
71895121|NCT01480180|143312408|OTHER||Poisson estimate|3.7|||<|0.001|TWO_SIDED|95.0|2.94|4.66||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.66|2.94|<0.001
71895122|NCT01480180|143312410|OTHER||Poisson estimate|3.27|||<|0.001|TWO_SIDED|95.0|2.59|4.11||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||4.11|2.59|<0.001
71895123|NCT01480180|143312412|OTHER||Poisson estimate|2.35|||<|0.001|TWO_SIDED|95.0|1.87|2.95||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||2.95|1.87|<0.001
71895124|NCT01480180|143312412|OTHER||Poisson estimate|4.39|||<|0.001|TWO_SIDED|95.0|3.09|6.24||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.||6.24|3.09|<0.001
71895125|NCT03429075|143312519|EQUIVALENCE|ANCOVA||||||0.17|||||||ANCOVA|||||||0.17
71895126|NCT00624338|143312565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.518|TWO_SIDED|95.0|0.74|1.82||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.82|0.74|0.518
71808860|NCT01570829|143119786|SUPERIORITY|||||||0.26||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with hip circumference data.||||0.26
71808861|NCT01570829|143119787|SUPERIORITY|||||||0.4||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Physical Health domain data.||||0.40
71808862|NCT01570829|143119787|SUPERIORITY|||||||0.34||||||"The p-value associated with treatment\*visit interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|ANOVA|||This analysis applies to rows with Mental Health domain data.||||0.34
71808863|NCT03364751|143119796|OTHER||LS Mean Difference|0.068||||0.297|TWO_SIDED|95.0|-0.06|0.196|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.196|-0.060|0.297
71808864|NCT03364751|143119796|OTHER||LS Mean Difference|-0.064||||0.55|TWO_SIDED|95.0|-0.273|0.146|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.146|-0.273|0.550
71808865|NCT03364751|143119797|OTHER||LS Mean Difference|0.043||||0.502|TWO_SIDED|95.0|-0.084|0.171|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.171|-0.084|0.502
71808866|NCT03364751|143119797|OTHER||LS Mean Difference|-0.02||||0.851|TWO_SIDED|95.0|-0.229|0.189|||Mixed Models Analysis|||Month 3: Difference between Cigarette and Dual Use||0.189|-0.229|0.851
71808867|NCT03364751|143119798|OTHER||LS Mean Difference|0.07||||0.376|TWO_SIDED|95.0|-0.085|0.224|||Mixed Models Analysis|||Month 3: Difference between Cigarette and IQOS||0.224|-0.085|0.376
71808868|NCT03364751|143119798|OTHER||LS Mean Difference|0.025||||0.848|TWO_SIDED|95.0|-0.229|0.279|||Mixed Models Analysis|||Month 3: Difference between Cigarette and DualUse||0.279|-0.229|0.848
71808869|NCT03364751|143119798|OTHER||LS Mean Difference|0.092||||0.246|TWO_SIDED|95.0|-0.064|0.247|||Mixed Models Analysis|||Month 6: Difference between Cigarette and IQOS||0.247|-0.064|0.246
71808870|NCT03364751|143119798|OTHER||LS Mean Difference|-0.105||||0.417|TWO_SIDED|95.0|-0.359|0.15|||Mixed Models Analysis|||Month 6: Difference between Cigarette and Dual Use||0.150|-0.359|0.417
71808871|NCT00675766|143119814|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.||Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.001
71808872|NCT00675766|143119814|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.||Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.005
71808873|NCT00675766|143119814|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.||Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||< 0.01
71808874|NCT00675766|143119814|SUPERIORITY_OR_OTHER||||||<|0.07|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.||Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||<0.07
71808875|NCT00675766|143119814|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.||Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.09
71808876|NCT00675766|143119814|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.||Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||.72
71808877|NCT00675766|143119814|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.||Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.65
71808878|NCT00675766|143119814|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Repeated Measures ANOVA|Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.||Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.||||0.79
71843326|NCT02382003|143200200|SUPERIORITY||Mean Difference (Net)|6.018||||0.049|TWO_SIDED|||||=No-train+Neut\~Pos+Anx,0.049=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≥0.198,50/50(all)\~No-train+Anx≥0.104,0.014=No-train+Neut\~50/50+Neut,0.627=No-train+Neut\~50/50+Anx,0.021=Pos+Anx\~50/50+Anx,0.764=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≥0.067|Likelihood Ratio Tests|2=all df|=No-train+Neut\~Pos+Anx,6.041=No-train+Neut\~Pos+Neut,Positive(all)\~No-train+Anx≤3.240,50/50(all)\~No-train+Anx≤4.534,8.525=No-train+Neut\~50/50+Neut,0.933=No-train+Neut\~50/50+Anx,7.686=Pos+Anx\~50/50+Anx,0.537=Pos+Anx\~50/50+Neut,Pos+Neut\~50/50(all)≤5.395|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.049
71895127|NCT00624338|143312565|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.003|TWO_SIDED|95.0|0.31|0.78||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.78|0.31|0.003
71895128|NCT00624338|143312566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984||||0.929|TWO_SIDED|95.0|0.69|1.4||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|||||1.40|0.69|0.929
71895129|NCT00624338|143312566|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.562||||0.009|TWO_SIDED|95.0|0.36|0.87||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||0.87|0.36|0.009
71895130|NCT00624338|143312567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.215||||0.412|TWO_SIDED|95.0|0.76|1.94||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|||||1.94|0.76|0.412
71895131|NCT00624338|143312567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.722||||0.198|TWO_SIDED|95.0|0.44|1.19||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.||||1.19|0.44|0.198
71895132|NCT05593432|143312577|SUPERIORITY||Response Rate Difference|29.4|STANDARD_ERROR_OF_MEAN|11.17||0.0129|TWO_SIDED|95.0|7.55|51.33||stratified by Baseline Investigator's Global Assessment (IGA) score (3 or 4)|Cochran-Mantel-Haenszel||stratified by Baseline IGA score (3 or 4)|||51.33|7.55|0.0129
71895133|NCT05593432|143312577|SUPERIORITY||Odds Ratio (OR)|4.04|||||TWO_SIDED|95.0|1.32|12.38|||||stratified by Baseline IGA score (3 or 4)|||12.38|1.32|
71895134|NCT05593432|143312578|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|30.6|STANDARD_ERROR_OF_MEAN|11.68||0.0141|TWO_SIDED|95.0|7.71|53.51|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||53.51|7.71|0.0141
71808879|NCT00675766|143119814|SUPERIORITY_OR_OTHER|||||||0.044|ONE_SIDED||||||Fisher Exact|One-sided Fisher's exact test with 1 degree of freedom.||Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.||||.044
71808880|NCT02275065|143119817|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71895135|NCT05593432|143312578|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|1.31|13.17|||||stratified by Baseline IGA score (3 or 4)|||13.17|1.31|
71895136|NCT05593432|143312580|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Response Rate Difference|40.3|STANDARD_ERROR_OF_MEAN|12.09||0.0027|TWO_SIDED|95.0|16.61|64.0|||Cochran-Mantel-Haenszel|stratified by Baseline IGA score (3 or 4)||||64.00|16.61|0.0027
71808881|NCT02275065|143119817|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71895137|NCT05593432|143312580|EQUIVALENCE|A Cochran-Mantel-Haenszel test stratified by Baseline IGA score (3 or 4) at a 2-sided α = 0.05 level was used for the comparison between ruxolitinib 1.5% cream BID and vehicle cream BID at Week 16.|Odds Ratio (OR)|6.67|||||TWO_SIDED|95.0|1.85|24.02|||||stratified by Baseline IGA score (3 or 4)|||24.02|1.85|
71808882|NCT02275065|143119817|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808883|NCT02275065|143119817|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808884|NCT02275065|143119820|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808885|NCT02275065|143119820|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808886|NCT02275065|143119820|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71895138|NCT05593432|143312582|EQUIVALENCE|A log-rank test stratified by randomization stratification factor, Baseline IGA score (3 or 4), was used for between-treatment group comparisons. The hazard ratio and its 95% confidence interval was estimated based on the stratified Cox regression model. using Efron's method accounting for ties.|Hazard Ratio (HR)|2.85||||0.0008|TWO_SIDED|95.0|1.51|5.381|||Log Rank|stratified by Baseline IGA score (3 or 4) between ruxolitinib 1.5% cream and vehicle cream|Cox regression model stratified by Baseline IGA score (3 or 4) was conducted to compare the difference in hazard rate between ruxolitinib 1.5% cream and vehicle cream|||5.381|1.510|0.0008
71808887|NCT02275065|143119820|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808888|NCT02275065|143119821|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71843327|NCT02382003|143200201|SUPERIORITY||Mean Difference (Net)|17.42|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\<0.001, 0.124=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 31.921=Positive\~50/50 training, 4.175=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
71843328|NCT02382003|143200201|SUPERIORITY||Mean Difference (Net)|0.634||||0.728|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.728
71895139|NCT03476850|143312589|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.883|TWO_SIDED||||||Mixed Models Analysis|||An a priori sample size calculation found 24 subjects per group (48 total) provided \>80% power to detect a 2 unit difference in patient reported pain based on a 2-sided test and significance level a = 0.05 assuming at least 3 measures per subject and a within subject covariance having a compound symmetric structure with a standard deviation in pain score of 3 units and within subject correlation of 0.5.||||.883
71895140|NCT03476850|143312590|SUPERIORITY||Median Difference (Final Values)|0.25||||0.977|TWO_SIDED||||||ANOVA|||||||.977
71895141|NCT03476850|143312591|SUPERIORITY||Odds Ratio (OR)|4.9||||0.009|TWO_SIDED||||||Chi-squared|||||||.009
71895142|NCT03476850|143312593|SUPERIORITY||Median Difference (Final Values)|18.0||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.110
71895143|NCT03476850|143312594|SUPERIORITY||Median Difference (Final Values)|0.26||||0.719|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.719
71895144|NCT02912364|143312610|OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||t-test, 2 sided|degrees of freedom = 22||||.34|.13|< .001
71895145|NCT02912364|143312611|OTHER||Mean Difference (Final Values)|0.54|||<|0.001|TWO_SIDED|95.0|0.3|0.79|||t-test, 2 sided|Degrees of freedom = 22.||||.79|.30|< .001
71895146|NCT01450137|143312615|SUPERIORITY||Risk Difference (RD)|0.45||||0.0301|TWO_SIDED|95.0|0.11|0.79|||Fisher Exact|||||0.79|0.11|0.0301
71895147|NCT01450137|143312616|SUPERIORITY||Risk Difference (RD)|0.65||||0.001|TWO_SIDED|95.0|0.36|0.94|||Fisher Exact|||||0.94|0.36|0.0010
71895148|NCT01450137|143312617|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71895149|NCT01450137|143312618|SUPERIORITY||Mean Difference (Final Values)|25.0||||0.0005|TWO_SIDED|95.0|11.0|39.0|||z-test||Difference between restricted mean survival time at 12 months|||39|11|0.0005
71895150|NCT04800315|143312637|SUPERIORITY||Mean Difference (Final Values)|-21.76||||0.003|TWO_SIDED|95.0|-35.81|-7.7|||ANCOVA|||||-7.70|-35.81|0.003
71895151|NCT04800315|143312637|SUPERIORITY||Mean Difference (Final Values)|-13.38||||0.057|TWO_SIDED|95.0|-27.19|0.43|||ANCOVA|||||0.43|-27.19|0.057
71895152|NCT04800315|143312637|SUPERIORITY||Mean Difference (Final Values)|-16.28||||0.029|TWO_SIDED|95.0|-30.88|-1.68|||ANCOVA|||||-1.68|-30.88|0.029
71895153|NCT04800315|143312638|OTHER|Risk Difference|Risk Difference VS Placebo|24.0||||0.004|TWO_SIDED|95.0|8.8|39.2|||Cochran-Mantel-Haenszel|||||39.2|8.8|0.004
71895154|NCT04800315|143312638|OTHER|Risk Difference|Risk Difference VS Placebo|15.3||||0.061|TWO_SIDED|95.0|0.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|0.8|0.061
71895155|NCT04800315|143312638|OTHER|Risk Difference|Risk Difference VS Placebo|28.9|||<|0.001|TWO_SIDED|95.0|13.6|44.2|||Cochran-Mantel-Haenszel|||||44.2|13.6|<0.001
71895156|NCT04800315|143312639|OTHER|Risk Difference|Difference VS Placebo|23.7||||0.018|TWO_SIDED|95.0|6.2|41.2|||Cochran-Mantel-Haenszel|||||41.2|6.2|0.018
71895157|NCT04800315|143312639|OTHER|Risk Difference|Difference VS Placebo|21.8||||0.033|TWO_SIDED|95.0|4.3|39.3|||Cochran-Mantel-Haenszel|||||39.3|4.3|0.033
71895158|NCT04800315|143312639|OTHER|Risk Difference|Difference VS Placebo|26.7||||0.006|TWO_SIDED|95.0|9.3|44.0|||Cochran-Mantel-Haenszel|||||44.0|9.3|0.006
71895159|NCT04800315|143312640|OTHER|Risk Difference|Risk Difference|18.1|||||TWO_SIDED|95.0|2.3|33.9|||Cochran-Mantel-Haenszel|||||33.9|2.3|
71895160|NCT04800315|143312640|OTHER|Risk Difference|Risk Difference|10.5|||||TWO_SIDED|95.0|-4.6|25.7|||Cochran-Mantel-Haenszel|||||25.7|-4.6|
71895161|NCT04800315|143312640|SUPERIORITY||Risk Difference|15.9|||||TWO_SIDED|95.0|0.4|31.4|||Cochran-Mantel-Haenszel|||||31.4|0.4|
71895162|NCT04800315|143312641|SUPERIORITY||Mean Difference (Final Values)|-28.16|||||TWO_SIDED|95.0|-41.89|-14.44|||ANCOVA|||||-14.44|-41.89|
71895163|NCT04800315|143312641|SUPERIORITY||Mean Difference (Final Values)|-14.36|||||TWO_SIDED|95.0|-27.26|-1.46|||ANCOVA|||||-1.46|-27.26|
71808889|NCT02275065|143119821|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808890|NCT02275065|143119821|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71808891|NCT02275065|143119821|OTHER||||||<|0.001||||||Comparison was made using the t-test at a 2-sided 0.05 significance level.|t-test, 2 sided|||||||<0.001
71895164|NCT04800315|143312641|SUPERIORITY||Mean Difference (Final Values)|-19.07|||||TWO_SIDED|95.0|-33.53|-4.62|||ANCOVA|||||-4.62|-33.53|
71895165|NCT04800315|143312642|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-22.5|||||TWO_SIDED|95.0|-41.46|-3.54|||ANCOVA|||||-3.54|-41.46|
71843329|NCT02382003|143200201|SUPERIORITY||Mean Difference (Net)|15.034|||<|0.001|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, 0.026=Pos+Anx\~No-train+Anx, 0.002=Pos+Neut\~No-train+Neut, 0.091=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≥ 0.081, Positive(all)\~50/50(all)\< 0.001|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 7.306=Pos+Anx\~No-train+Anx, 12.672=Pos+Neut\~No-train+Neut, 4.802=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train(all)≤5.037, Positive(all)\~50/50(all)≥16.239|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||<0.001
71895166|NCT04800315|143312642|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-13.17|||||TWO_SIDED|95.0|-30.67|4.33|||ANCOVA|||||4.33|-30.67|
71895167|NCT04800315|143312642|OTHER|Adjusted Mean Difference VS Placebo|Adjusted Mean Difference VS Placebo|-16.32|||||TWO_SIDED|95.0|-36.4|3.75|||ANCOVA|||||3.75|-36.40|
71895168|NCT04800315|143312643|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.5||||0.042|TWO_SIDED|95.0|2.7|34.3|||Cochran-Mantel-Haenszel|||||34.3|2.7|0.042
71895169|NCT04800315|143312643|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|19.9||||0.029|TWO_SIDED|95.0|4.1|35.7|||Cochran-Mantel-Haenszel|||||35.7|4.1|0.029
71895170|NCT04800315|143312643|OTHER|Risk Difference VS Placebo|Risk Difference VS Placebo|18.0||||0.052|TWO_SIDED|95.0|2.3|33.6|||Cochran-Mantel-Haenszel|||||33.6|2.3|0.052
71895171|NCT04800315|143312645|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-23.12|||||TWO_SIDED|95.0|-41.48|-4.76|||ANCOVA|||||-4.76|-41.48|
71808892|NCT03015402|143119834|SUPERIORITY|Pre-randomization characteristics of 2 groups will be presented using the median (IQR) or frequency tables at each study sequence. The difference of mPAP during submax exercise compared between placebo and nitrite at 10 weeks (i.e. week 10 RHC of placebo vs week 10 RHC of nitrite) using parametric PK-cross analysis (i.e. ANOVA to determine the sequence, period, carryover, \& treatment effects). Post-exercise values before \& after crossover will be compared between 2 groups using similar approach.||||||0.2|||||||ANOVA|||||||0.20
71808893|NCT01995461|143119856|SUPERIORITY_OR_OTHER|||||||0.0252|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0252
71808894|NCT01995461|143119857|SUPERIORITY_OR_OTHER|||||||0.0154|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.0154
71808895|NCT01995461|143119858|SUPERIORITY_OR_OTHER|||||||0.1349|TWO_SIDED||||||t-test, 2 sided|paired t-test||||||0.1349
71895172|NCT04800315|143312645|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-8.28|||||TWO_SIDED|95.0|-25.16|8.59|||ANCOVA|||||8.59|-25.16|
71895173|NCT04800315|143312645|OTHER|Adjusted mean difference VS Placebo|Adjusted mean difference VS Placebo|-10.87|||||TWO_SIDED|95.0|-29.39|7.66|||ANCOVA|||||7.66|-29.39|
71895174|NCT01287117|143312674|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.96||||0.001|TWO_SIDED|95.0|-4.71|-1.21||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.21|-4.71|0.0010
71895175|NCT01287117|143312674|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.95||||0.0012|TWO_SIDED|95.0|-4.72|-1.18||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.18|-4.72|0.0012
71895176|NCT01287117|143312674|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.8|||<|0.0001|TWO_SIDED|95.0|-7.49|-4.1||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.10|-7.49|<0.0001
71808896|NCT01201057|143119868|SUPERIORITY|||||||0.006|||||||Cochran-Mantel-Haenszel|||||||0.006
71808897|NCT01201057|143119869|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71808898|NCT01201057|143119870|SUPERIORITY|||||||0.025|||||||Cochran-Mantel-Haenszel|||||||0.025
71808899|NCT04322682|143119873|SUPERIORITY||Odds Ratio (OR)|0.79||||0.081|TWO_SIDED|95.1|0.61|1.03|||Chi-squared|||||1.03|0.61|0.081
71895177|NCT01287117|143312675|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.75||||0.0035|TWO_SIDED|95.0|-9.59|-1.92||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-1.92|-9.59|0.0035
71808900|NCT04322682|143119874|SUPERIORITY||Odds Ratio (OR)|0.56||||0.291|TWO_SIDED|95.0|0.19|1.67|||Chi-squared|||||1.67|0.19|0.291
71808901|NCT04322682|143119875|SUPERIORITY||Odds Ratio (OR)|0.79||||0.077|TWO_SIDED|95.0|0.6|1.03|||Chi-squared|||||1.03|0.60|0.077
71808902|NCT04322682|143119876|SUPERIORITY||Odds Ratio (OR)|0.53||||0.08|TWO_SIDED|95.0|0.25|1.09|||Chi-squared|||||1.09|0.25|0.080
71808903|NCT04322682|143119877|SUPERIORITY||Odds Ratio (OR)|0.75||||0.042|TWO_SIDED|95.0|0.57|0.99||P-Value is for the comparison of the treatment group within patients with Covid-19 confirmed by PCR.|Regression, Logistic|Logistic-regression model including the treatment group, the PCR-confirmed Covid-19 subgroup factor (yes/no) and their interaction was performed.||||0.99|0.57|0.042
71808904|NCT00605280|143119881|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0047|TWO_SIDED|95.0|1.32|4.3||Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.|Cochran-Mantel-Haenszel|||||4.30|1.32|0.0047
71895178|NCT01287117|143312675|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.54||||0.0008|TWO_SIDED|95.0|-10.33|-2.75||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-2.75|-10.33|0.0008
71895179|NCT01287117|143312675|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.8|||<|0.0001|TWO_SIDED|95.0|-16.44|-9.16||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-9.16|-16.44|<0.0001
71895180|NCT01287117|143312676|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.75||||0.0149|TWO_SIDED|95.0|-4.95|-0.54||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||-0.54|-4.95|0.0149
71808905|NCT00605280|143119882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.1904|TWO_SIDED|95.0|0.85|2.53|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||2.53|0.85|0.1904
71808906|NCT00605280|143119883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.2466|TWO_SIDED|95.0|0.74|3.34|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.34|0.74|0.2466
71808907|NCT00605280|143119884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.1388|TWO_SIDED|95.0|0.86|3.26|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||3.26|0.86|0.1388
71808908|NCT00605280|143119885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0468|TWO_SIDED|95.0|0.07|0.99|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.99|0.07|0.0468
71808909|NCT00605280|143119886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.1124|TWO_SIDED|95.0|0.73|11.55|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||11.55|0.73|0.1124
71808910|NCT00605280|143119887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.1788|TWO_SIDED|95.0|0.16|1.42|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||1.42|0.16|0.1788
71808911|NCT00605280|143119888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.12||||0.0048|TWO_SIDED|95.0|1.45|18.06|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||18.06|1.45|0.0048
71808912|NCT00605280|143119889|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean|3.9||||0.004|TWO_SIDED|95.0|1.25|6.54|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||6.54|1.25|0.0040
71808913|NCT00605280|143119890|SUPERIORITY_OR_OTHER||LS Mean|4.57||||0.0011|TWO_SIDED|95.0|1.85|7.29|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.||||7.29|1.85|0.0011
71808914|NCT00605280|143119891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.0023|TWO_SIDED|95.0|0.24|0.74|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.74|0.24|0.0023
71808915|NCT00605280|143119892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.0008|TWO_SIDED|95.0|0.23|0.69|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.||||0.69|0.23|0.0008
71808916|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.||||0.0007
71808917|NCT00205348|143119942|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.||||<0.0001
71808918|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.||||0.0002
71808919|NCT00205348|143119942|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.||||<0.0001
71808920|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.0973|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.||||0.0973
71808921|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.1772|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.||||0.1772
71808922|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.||||0.0062
71843330|NCT02382003|143200202|SUPERIORITY||Mean Difference (Net)|13.924|||<|0.001|TWO_SIDED|||||=Positive\~No-training, Positive\~50/50 training\< 0.001, 0.100=50/50\~No-training Alpha = .05|Likelihood Ratio Tests|2=df Positive\~No-training, 2=df Positive\~50/50 training, 2=df 50/50\~No-training|=Positive\~No-training, 15.288=Positive\~50/50 training, 4.605=50/50\~No-training|Effect of CBM-I condition: The main effect of CBM-I was represented by three binary variables in the main effect models (Positive vs. No-training control; 50/50 vs. No- training control; Positive vs. 50/50). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||< 0.001
71808923|NCT00205348|143119942|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.||||<0.0001
71808924|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.||||0.0002
71808925|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.2125|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.||||0.2125
71843331|NCT02382003|143200202|SUPERIORITY||Mean Difference (Net)|4.011||||0.135|TWO_SIDED|||||=Neutral\~Anxiety prime Alpha = .05|Likelihood Ratio Tests|2=df Neutral\~Anxiety prime|=Neutral\~Anxiety prime|Effect of Imagery Prime Type: The main effect of imagery prime was represented by one binary variable (neutral vs. anxiety imagery). Due to high attrition, latent growth curve modeling was used instead of the planned approach (mixed effects models with multiple imputation of missing values) to minimize bias due to missing data estimation. Because omnibus tests were not run, results for all comparisons are listed below.||||0.135
71843332|NCT02382003|143200202|SUPERIORITY||Mean Difference (Net)|9.402||||0.009|TWO_SIDED|||||=Pos+Anx\~No-train+Neut, Pos+Anx\~No-train+Anx\<0.048, Pos+Neut\~No-train+Neut\<0.001, 0.055=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≥0.139, 0.034=No-train+Neut\~50/50+Neut, 0.340=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≥ 0.087|Likelihood Ratio Tests|2=all df|=Pos+Anx\~No-train+Neut, 6.076=Pos+Anx\~No-train+Anx, 14.525=Pos+Neut\~No-train+Neut, 5.811=Pos+Neut\~No-train+Anx, 50/50(all)\~No-train+Anx≤3.950, 6.770=No-train+Neut\~50/50+Neut, 2.158=No-train+Neut\~50/50+Anx, Pos(all)\~50/50(all)≤4.876|Effect of CBM-I condition and Imagery Prime Type interaction: Each cell of the interaction was represented by one of 5 binary variables, set to 1 if a participant was in that group, and 0 otherwise; the sixth group (No-training + neutral prime) was considered a reference group, and was represented by all variables being 0. Due to high attrition, latent growth curve modeling was used instead of the planned approach. Because omnibus tests were not run, results for all comparisons are listed below.||||0.009
71843333|NCT05934292|143200215|OTHER||Geometric Mean Ratio|1.5|||||TWO_SIDED|90.0|0.98|2.31|||||Geometric mean ratio (GMR) and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.31|0.98|
71843334|NCT05934292|143200215|OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|0.74|1.74|||Geometric Mean Ratio||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.74|0.74|
71895181|NCT01287117|143312676|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.44||||0.0017|TWO_SIDED|95.0|-5.57|-1.32||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.32|-5.57|0.0017
71808926|NCT00205348|143119942|SUPERIORITY_OR_OTHER|||||||0.0332|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.||||0.0332
71808927|NCT01311674|143119948|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.96
71843335|NCT05934292|143200215|OTHER||Geometric Mean Ratio|1.75|||||TWO_SIDED|90.0|1.1|2.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.78|1.10|
71808928|NCT01311674|143119949|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71808929|NCT01311674|143119950|SUPERIORITY|||||||0.84|||||||Log Rank|||||||0.84
71843336|NCT05934292|143200215|OTHER||Geometric Mean Ratio|1.17|||||TWO_SIDED|90.0|0.77|1.77|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.77|0.77|
71808930|NCT01311674|143119951|SUPERIORITY|||||||0.24|||||||Log Rank|||||||0.24
71808931|NCT01311674|143119952|SUPERIORITY|||||||0.27|||||||Log Rank|||||||0.27
71808932|NCT00374322|143119953|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.286|TWO_SIDED|95.0|0.77|1.08||The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.|Log Rank||Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.|||1.08|0.77|0.286
71895182|NCT01287117|143312676|SUPERIORITY_OR_OTHER||Least squares mean difference|-6.93|||<|0.0001|TWO_SIDED|95.0|-9.1|-4.76||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-4.76|-9.10|<0.0001
71808933|NCT00450411|143119975|OTHER|||||||||||||||||It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming's multiple testing procedure with two interim analyses and one final analysis.|Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.|||
71808934|NCT03969719|143119987|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-12.44||||0.0696|TWO_SIDED|90.0|-22.37|-1.25|||ANCOVA|||||-1.25|-22.37|0.0696
71808935|NCT03969719|143119987|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-14.64||||0.0288|TWO_SIDED|90.0|-24.18|-3.89|||ANCOVA|||||-3.89|-24.18|0.0288
71808936|NCT03969719|143119988|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.08||||0.6336|TWO_SIDED|90.0|-0.36|0.2|||Mixed Models Analysis|||||0.20|-0.36|0.6336
71808937|NCT03969719|143119988|EQUIVALENCE|The comparisons of PF-06835919 to placebo was performed at a Type I error rate of 10%.|Mean Difference (Final Values)|-0.25||||0.1266|TWO_SIDED|90.0|-0.52|0.02|||Mixed Models Analysis|||||0.02|-0.52|0.1266
71808938|NCT04184791|143120000|OTHER|A linear mixed-effects analysis of variance (LM-ANOVA) model was used to determine the effect of L-Dopa, frequency, the interaction of levodopa and frequency, and the interaction of frequency and contact pairs on gait parameters. The fixed effects were L-Dopa condition (ON vs. OFF), stimulation frequency (LFS;60 Hz vs. HFS;180 Hz), contact pairs \[1-(R)/1-(L); 2-(R)/2-(L); 3-(R)/3-(L); 4-(R)/4-(L)\], and assistive device (presence vs. absence) and the patient effect was considered random.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71808939|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.87|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.87
71808940|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.78|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.78
71895183|NCT01287117|143312677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.39||||0.0879|TWO_SIDED|95.0|0.95|2.03||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.||2.03|0.95|0.0879
71808941|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.67|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.67
71808942|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.52|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.52
71808943|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.39|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.39
71808944|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.06||0.26|TWO_SIDED|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.18|-0.05|0.26
71808945|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.31|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.31
71808946|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.22|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.22
71808947|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.14|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.14
71808948|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.09
71808949|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.05|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.05
71808950|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.04|STANDARD_DEVIATION|0.07||0.03|TWO_SIDED|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.09|-0.20|0.03
71808951|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.85|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.85
71808952|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.79|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.79
71808953|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.71|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.71
71808954|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.61|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.61
71808955|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.51|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.51
71808956|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.08|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.23|-0.06|0.41
71808957|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.47|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.47
71808958|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.36|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.36
71808959|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.26|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.26
71808960|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.19|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.19
71808961|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.13|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.13
71843337|NCT05934292|143200216|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.05|2.46|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||2.46|1.05|
71843338|NCT05934292|143200216|OTHER||Geometric Mean ratio|0.79|||||TWO_SIDED|90.0|0.37|1.72|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.72|0.37|
71843339|NCT05934292|143200216|OTHER||Geometric Mean Ratio|1.42|||||TWO_SIDED|90.0|0.8|2.54|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||2.54|0.80|
71843340|NCT05934292|143200216|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.78|0.78|
71843341|NCT05934292|143200217|OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.71|1.37|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls.|||1.37|0.71|
71895184|NCT01287117|143312677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.0301|TWO_SIDED|95.0|1.04|2.14||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||2.14|1.04|0.0301
71895185|NCT01287117|143312677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.34|||<|0.0001|TWO_SIDED|95.0|1.63|3.36||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||3.36|1.63|<0.0001
71895186|NCT01287117|143312678|SUPERIORITY_OR_OTHER|||||||0.0148||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0148
71895187|NCT01287117|143312678|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||<0.0001
71895188|NCT01287117|143312678|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71895189|NCT01287117|143312679|SUPERIORITY_OR_OTHER|||||||0.0118||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.0118
71895190|NCT01287117|143312679|SUPERIORITY_OR_OTHER|||||||0.0226||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||||0.0226
71808962|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.0|STANDARD_DEVIATION|0.07||0.09|TWO_SIDED|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.14|-0.16|0.09
71808963|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.78|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.78
71808964|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.69|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.69
71808965|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.59
71808966|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.50
71808967|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.39|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.39
71808968|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.11|0.30
71808969|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.68|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.68
71808970|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.59|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.59
71808971|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.5|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.50
71808972|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.4|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.40
71808973|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.3|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.30
71843342|NCT05934292|143200217|OTHER||Geometric Mean Ratio|0.6|||||TWO_SIDED|90.0|0.34|1.04|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls.|||1.04|0.34|
71843343|NCT05934292|143200217|OTHER||Geometric Mean Ratio|0.9|||||TWO_SIDED|90.0|0.64|1.27|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls.|||1.27|0.64|
71843344|NCT05934292|143200217|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.78|1.78|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls.|||1.78|0.78|
71843345|NCT05934292|143200220|OTHER||Geometric Mean Ratio|0.67|||||TWO_SIDED|90.0|0.43|1.02|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.02|0.43|
71895191|NCT01287117|143312679|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (\< 13 vs ≥ 13) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71896332|NCT03114969|143314794|SUPERIORITY||Odds Ratio (OR)|12.145||||0.09|TWO_SIDED|95.0|0.68|216.818||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||216.818|0.680|0.090
71677353|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.509|||||TWO_SIDED|95.0|1.891|3.33||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.330|1.891|
71808974|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.04|STANDARD_DEVIATION|0.08||0.22|TWO_SIDED|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.20|-0.14|0.22
71808975|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.41|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.41
71808976|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.32|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.32
71808977|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.24|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.24
71843346|NCT05934292|143200220|OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.58|1.35|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.35|0.58|
71843347|NCT05934292|143200220|OTHER||Geomtric Mean ratio|0.57|||||TWO_SIDED|90.0|0.36|0.91|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.91|0.36|
71843348|NCT05934292|143200220|OTHER||Geomtric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.57|1.29|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.29|0.57|
71843349|NCT05934292|143200221|OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.83|1.67|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||1.67|0.83|
71895192|NCT01287117|143312680|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.34||||0.0124|TWO_SIDED|95.0|-4.17|-0.51||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||-0.51|-4.17|0.0124
71808978|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.16|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.16
71895193|NCT01287117|143312680|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.16||||0.0012|TWO_SIDED|95.0|-5.05|-1.27||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||-1.27|-5.05|0.0012
71808979|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.11|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.11
71808980|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.08||0.07|TWO_SIDED|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals|||0.13|-0.19|0.07
71808981|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.41|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.41
71808982|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.32|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.32
71808983|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.25|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.25
71808984|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.18|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.18
71808985|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.12|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.12
71808986|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.02|STANDARD_DEVIATION|0.09||0.07|TWO_SIDED|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals|||0.15|-0.20|0.07
71808987|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.45|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.45
71808988|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.37|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.37
71808989|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.3|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.30
71808990|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.22|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.22
71808991|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.17|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.17
71808992|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.01|STANDARD_DEVIATION|0.1||0.12|TWO_SIDED|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals|||0.17|-0.20|0.12
71843350|NCT05934292|143200221|OTHER||Geometric Mean ratio|1.08|||||TWO_SIDED|90.0|0.78|1.5|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||1.50|0.78|
71843351|NCT05934292|143200221|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.5|0.89|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Pre-Hemodialysis/ Panel D-Healthy Controls|||0.89|0.50|
71843352|NCT05934292|143200221|OTHER||Geometric Mean Ratio|1.4|||||TWO_SIDED|90.0|1.0|1.97|||||GMR and 90% CI for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel C-ESRD Enlicitide Decanoate Post-Hemodialysis/ Panel D-Healthy Controls|||1.97|1.00|
71843353|NCT05934292|143200226|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
71843354|NCT05934292|143200226|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
71843355|NCT05934292|143200227|OTHER||Geometric Mean Ratio|0.32|||||TWO_SIDED|90.0|0.14|0.74|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.74|0.14|
71843356|NCT05934292|143200227|OTHER||Geometric Mean Ratio|0.09|||||TWO_SIDED|90.0|0.04|0.22|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.22|0.04|
71843357|NCT05934292|143200228|OTHER||Geometric Mean Ratio|0.29|||||TWO_SIDED|90.0|0.16|0.55|||||GMR and 90% CI were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel A-Moderate Renal Impairment (RI)/Panel D-Healthy controls|||0.55|0.16|
71895194|NCT01287117|143312680|SUPERIORITY_OR_OTHER||Least squares mean difference|-5.73|||<|0.0001|TWO_SIDED|95.0|-7.59|-3.87||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-3.87|-7.59|<0.0001
71895195|NCT01287117|143312681|SUPERIORITY_OR_OTHER||Least squares mean difference|0.26||||0.7956|TWO_SIDED|95.0|-1.76|2.28||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||2.28|-1.76|0.7956
71895196|NCT01287117|143312681|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.31||||0.2286|TWO_SIDED|95.0|-3.46|0.84||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.||0.84|-3.46|0.2286
71843358|NCT05934292|143200228|OTHER||Geometric Mean Ratio|0.14|||||TWO_SIDED|90.0|0.06|0.36|||||GMR and 90% confidence interval (CI) were calculated using a linear fixed effects model performed on natural log-transformed values. GMR: Panel B-Severe RI/Panel D-Healthy controls|||0.36|0.06|
71843359|NCT04479787|143200232|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
71843360|NCT04479787|143200233|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||< 0.0001
71843361|NCT04479787|143200234|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
71843362|NCT04479787|143200235|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
71843363|NCT04479787|143200236|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
71843364|NCT04479787|143200237|OTHER||||||<|0.0001|||||||Two-sided Z-Test|||||||<0.0001
71843365|NCT04479787|143200238|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
71843366|NCT04479787|143200239|OTHER||||||<|0.0001|||||||Two-sample t-test.|||||||<0.0001
71843367|NCT05714059|143200244|NON_INFERIORITY|The overall mean change in HbA1c, from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
71843368|NCT05714059|143200244|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period was estimated and compared by a non-inferiority test to the threshold of -0.50% with a margin of 0.4%. A significance level of 0.025 (one-sided) was used|Mean difference from baseline to exit|-0.7|||<|0.001|TWO_SIDED|95.0|-0.8|-0.6|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.6|-0.8|<0.001
71843369|NCT05714059|143200245|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 65.3% with a margin of 7.5%.|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
71843370|NCT05714059|143200245|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 73.7% with a margin of 7.5%.|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
71843371|NCT05714059|143200246|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.71% with a margin of 2%.|Mean value (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from last 6-7 weeks of 3 month study period was estimated for this endpoint.|||0.4|0.3|<0.001
71843372|NCT05714059|143200246|NON_INFERIORITY|The mean % time in hypoglycemia (\< 54 mg/dL) was estimated and compared by a non-inferiority test to the threshold of 0.86% with a margin of 2%.|Mean value (Final Values)|0.2|||<|0.001|TWO_SIDED|95.0|0.1|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) were summarized from last 6-7 weeks of 3 month study period for this endpoint|||0.3|0.1|<0.001
71843373|NCT05714059|143200247|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 65.3% by a simple superiority test|Mean value (Final Values)|71.4|||<|0.001|TWO_SIDED|95.0|69.5|73.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||73.3|69.5|<0.001
71843374|NCT05714059|143200247|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) was estimated and compared to a threshold of 73.7% by a simple superiority test|Mean value (Final Values)|80.2|||<|0.001|TWO_SIDED|95.0|78.7|81.8|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR 70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||81.8|78.7|<0.001
71895197|NCT01287117|143312681|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.96|-2.2||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||-2.20|-5.96|<0.0001
71843375|NCT05648890|143200264|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between MMSE and TEGEST test before operation.||||<0.0001
71843376|NCT05648890|143200265|OTHER|Spearman's ran correlation coefficient was used .|||||<|0.001|||||||Spearman's ran correlation coefficient|Spearman's ran correlation coefficient was used for correlation between two quantities.||Correlation between MMSE and TEGEST after operation||||< .001
71843377|NCT05648890|143200266|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and Clock drawing test before operation.|Spearman's rank correlation coefficient was used.|||<0.0001
71843378|NCT05648890|143200267|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.001|||||||Spearman's rank correlation coefficient|||Correlation between TEGEST and clock drawing test after operation.||||<0.001
71895198|NCT01287117|143312682|SUPERIORITY_OR_OTHER|||||||0.4867||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4867
71808993|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.72|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.72
71843379|NCT05648890|143200268|OTHER|Spearman's rank correlation coefficient.|||||<|0.001|||||||Spearman's rank correlation coefficien|||Correlation between MMSE and Clock drawing test before operation.||||<0.001
71843380|NCT05648890|143200268|OTHER|Mann-Whitney U test before operation.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Clock drawing before operation.||||0.023
71843381|NCT05648890|143200269|OTHER|Spearman's rank correlation coefficient|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation between Clock drawing test and MMSE after operation.||||<0.0001
71843382|NCT05648890|143200270|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with MMSE before operation.||||<0.0001
71843383|NCT05648890|143200270|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with TEGEST before operation.||||<0.0001
71843384|NCT05648890|143200270|OTHER|Spearman's rank correlation coefficient was used.|||||<|0.0001|||||||Spearman's rank correlation coefficient|||Correlation of Clinical frailty scale with Clock drawing test before operation.||||<0.0001
71843385|NCT05648890|143200271|OTHER|Mann-Whitney U test.||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Respondents living at a house or in apartment and relationships with Clinical frailty scale.||||.562
71843386|NCT05648890|143200272|OTHER|Mann-Whitney test was used.||||||0.129|||||||Wilcoxon (Mann-Whitney)|||Respondents living with with family or alone and relationship with Clinical frailty scale.||||0.129
71843387|NCT05648890|143200273|OTHER|Mann-Whintney test was used.||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Relationship between respondents living at home with stairs and respondents living at home with an elevator and Clinical frailty scale.||||0.019
71808994|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.65|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.65
71808995|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.57|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.57
71808996|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.48|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.48
71843388|NCT02379351|143200359|OTHER|This pilot study is primarily descriptive statistics||||||0.1|||||||Chi-squared|Data analysis will use mostly descriptive statistics - parametric and nonparametric statistics will be used as indicated (Chi-squared)||||||.1
71843389|NCT02379351|143200360|NON_INFERIORITY|Likert Scale of Provider Satisfaction|||||<|0.01|||||||Chi-squared|Data analysis will use mostly descriptive statistics: parametric and nonparametric statistics will be used as indicated.|||Likert Scale of Provider Satisfaction|||<0.01
71843390|NCT02422615|143200367|SUPERIORITY||Cox Proportional Hazard|0.593||||4.1e-07|TWO_SIDED|95.0|0.48|0.732|||Log Rank|||||0.732|0.480|0.00000041
71843391|NCT02422615|143200368|SUPERIORITY||Cox Proportional Hazard|0.724||||0.00455|TWO_SIDED|95.0|0.568|0.924|||Log Rank|||||0.924|0.568|0.00455
71843392|NCT02422615|143200369|SUPERIORITY||Cox Proportional Hazard|0.492|||||TWO_SIDED|95.0|0.345|0.703||||||||0.703|0.345|
71843393|NCT06688357|143200410|SUPERIORITY||Cohen's d|0.99||||0.077|TWO_SIDED|||||t (13) = 1.920. Only 1 comparison with 2 means, thus no adjustment necessary|t-test, 2 sided|||Independent sample t-test conducted to examine difference in pre-post intervention change scores for the active vs sham intervention groups. Cohen's d was calculated to determine effect size.||||.077
71843394|NCT06688357|143200411|SUPERIORITY||Cohen's D|0.779||||0.159|TWO_SIDED|||||t(13) = 1.504; only 1 comparison of 2 values, thus no adjustment is necessary|t-test, 2 sided|||independent sample t-test; Cohen's d effect size||||.159
71843395|NCT06688357|143200412|SUPERIORITY||Cohen's D|0.356||||0.503|TWO_SIDED|||||t (13) = 0.688; only 1 comparison, adjustment not necessary|t-test, 2 sided|df = 13||independent samples t-test, cohen's d effect size||||.503
71843396|NCT06688357|143200413|SUPERIORITY||Cohen's D|-0.922||||0.08|TWO_SIDED|||||t(13) = 1.893; only one comparison of 2 scores, thus no adjustment for multiple comparisons was necessary|t-test, 2 sided|df = 13||Independent sample t-test used to examine pre-post intervention change scores in active vs sham groups; Cohen's d was calculated to estimate effect size||||0.08
71843397|NCT06688357|143200414|SUPERIORITY||Cohen's D|0.793||||0.149|TWO_SIDED|||||t (13) = 1.533; only 1 comparison, no adjustment necessary|t-test, 2 sided|||independent sample t-test, Cohen d effect size||||.149
71843398|NCT06688357|143200415|SUPERIORITY||Cohen's D|0.905||||0.104|TWO_SIDED|||||t(13) = 1.749; only 1 comparison with 2 values, thus no adjustment for multiple comparisons|t-test, 2 sided|df = 13||independent sample t-test was used to examine difference in Post-Pre intervention change in the Active vs the Sham groups; Effect size was estimated using Cohen's d.||||.104
71843399|NCT06688357|143200416|SUPERIORITY||Cohen's D|-0.267||||0.614|TWO_SIDED|||||t(13) = -.516; only 1 comparison of 2 means, no adjustment needed|t-test, 2 sided|||independent sample t-tests examining Post-Baseline differences for the Active vs the Sham groups; Effect size computed using Cohen's d score||||.614
71843400|NCT06688357|143200417|SUPERIORITY||Cohen's D|0.652||||0.23|TWO_SIDED|||||t(13) = -1.260; only 1 comparison of 2 values, no need for adjustment|t-test, 2 sided|||independent samples t-test, effect size computation (cohen's d)||||.230
71843401|NCT04899674|143200418|OTHER||Ratio of gMeans [%]|94.6|||||TWO_SIDED|90.0|86.3|103.8|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone). Intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||103.8|86.3|
71843402|NCT04899674|143200419|OTHER||Ratio of gMeans[%]|90.7|||||TWO_SIDED|90.0|74.3|110.7|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Intra-individual geometric coefficient of variation (gCV \[%\])=31.5."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA) model. The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||110.7|74.3|
71843403|NCT04899674|143200420|OTHER||Ratio of gMeans [%]|95.1|||||TWO_SIDED|90.0|86.7|104.3|||||"Ratio of Geometric Least Squares Means (gMeans) was calculated as (gMean of BI 1358894 + bupropion)/(gMean of bupropion alone).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])=13.9."|The statistical model used for the analysis of the primary endpoints was an Analysis of Variance (ANOVA). The model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' was considered as random, whereas the effect 'treatment' was considered as fixed.||104.3|86.7|
71843404|NCT05155306|143200427|OTHER||Geometric mean ratio [%]|89.1|||||TWO_SIDED|90.0|79.5|99.7|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.067.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.7|79.5|
71843405|NCT05155306|143200427|OTHER||Geometric mean ratio [%]|98.1|||||TWO_SIDED|90.0|94.4|101.9|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.022.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||101.9|94.4|
71843406|NCT05155306|143200427|OTHER||Geometric mean ratio [%]|202.4|||||TWO_SIDED|90.0|180.1|227.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.069.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||227.5|180.1|
71808997|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.39|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.39
71808998|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.09||0.3|TWO_SIDED|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals|||0.24|-0.13|0.30
71808999|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.76|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.76
71809000|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.71|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.71
71809001|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.65|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.65
71809002|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.59|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.59
71809003|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.53|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.53
71809004|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.09|STANDARD_DEVIATION|0.12||0.46|TWO_SIDED|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals|||0.32|-0.15|0.46
71809005|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.68|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.68
71809006|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.61|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.61
71809007|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.55|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.55
71809008|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.46|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.46
71809009|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.4|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.40
71809010|NCT02130193|143120024|SUPERIORITY_OR_OTHER||Posterior mean difference|0.05|STANDARD_DEVIATION|0.11||0.33|TWO_SIDED|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals|||0.28|-0.15|0.33
71809011|NCT02130193|143120028|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.013|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.013
71809012|NCT02130193|143120028|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.006|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.006
71809013|NCT02130193|143120028|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.003|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.003
71843407|NCT05155306|143200427|OTHER||Geometric mean ratio [%]|173.8|||||TWO_SIDED|90.0|158.3|190.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.055.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||190.8|158.3|
71809014|NCT02130193|143120028|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977||0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|0.001
71809015|NCT02130193|143120028|SUPERIORITY_OR_OTHER||Posterior mean difference|2.48|STANDARD_DEVIATION|0.977|<|0.001|TWO_SIDED|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||4.43|0.92|<0.001
71809016|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|1.29||0.6|TWO_SIDED|95.0|-2.81|2.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 1 month. Data presented are for 95% equal-tailed credible intervals|||2.17|-2.81|0.60
71809017|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.58|STANDARD_DEVIATION|1.42||0.65|TWO_SIDED|95.0|-3.11|2.37||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 2 month. Data presented are for 95% equal-tailed credible intervals|||2.37|-3.11|0.65
71809018|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.46|STANDARD_DEVIATION|1.52||0.83|TWO_SIDED|95.0|-4.43|1.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 3 month. Data presented are for 95% equal-tailed credible intervals|||1.45|-4.43|0.83
71809019|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.2|STANDARD_DEVIATION|1.53||0.78|TWO_SIDED|95.0|-4.07|1.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 4 month. Data presented are for 95% equal-tailed credible intervals|||1.90|-4.07|0.78
71809020|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.96|STANDARD_DEVIATION|1.56||0.73|TWO_SIDED|95.0|-3.82|2.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 5 month. Data presented are for 95% equal-tailed credible intervals|||2.28|-3.82|0.73
71809021|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.93|STANDARD_DEVIATION|1.58||0.72|TWO_SIDED|95.0|-4.01|2.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 6 month. Data presented are for 95% equal-tailed credible intervals|||2.26|-4.01|0.72
71809022|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.0|STANDARD_DEVIATION|1.58||0.73|TWO_SIDED|95.0|-4.15|2.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.09|-4.15|0.73
71809023|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.48|STANDARD_DEVIATION|1.69||0.81|TWO_SIDED|95.0|-4.71|1.76||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.76|-4.71|0.81
71809024|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.23|STANDARD_DEVIATION|1.75||0.76|TWO_SIDED|95.0|-4.66|2.22||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 9 month. Data presented are for 95% equal-tailed credible intervals|||2.22|-4.66|0.76
71843408|NCT05155306|143200428|OTHER||Geometric mean ratio [%]|83.0|||||TWO_SIDED|90.0|69.6|99.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.106.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||99.0|69.6|
71843409|NCT05155306|143200428|OTHER||Geometric mean ratio [%]|99.7|||||TWO_SIDED|90.0|88.7|112.0|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.070.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||112.0|88.7|
71843410|NCT05155306|143200428|OTHER||Geometric mean ratio [%]|153.6|||||TWO_SIDED|90.0|126.0|187.3|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.121.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.3|126.0|
71843411|NCT05155306|143200428|OTHER||Geometric mean ratio [%]|121.4|||||TWO_SIDED|90.0|99.6|147.8|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.120.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||147.8|99.6|
71843412|NCT05155306|143200429|OTHER||Geometric mean ratio [%]|89.9|||||TWO_SIDED|90.0|80.4|100.4|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.066.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||100.4|80.4|
71843413|NCT05155306|143200429|OTHER||Geometric mean ratio [%]|100.4|||||TWO_SIDED|90.0|96.8|104.1|||||Ratio is calculated as test/reference. Geometric Standard Error = 1.021.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||104.1|96.8|
71809025|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.26|STANDARD_DEVIATION|1.74||0.91|TWO_SIDED|95.0|-5.66|0.99||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.99|-5.66|0.91
71809026|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.05|STANDARD_DEVIATION|1.73||0.71|TWO_SIDED|95.0|-4.73|2.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 11 month. Data presented are for 95% equal-tailed credible intervals|||2.13|-4.73|0.71
71895199|NCT01287117|143312682|SUPERIORITY_OR_OTHER|||||||0.1747||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.1747
71809027|NCT02130193|143120029|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.35|STANDARD_DEVIATION|1.74||0.78|TWO_SIDED|95.0|-4.77|2.04||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 12 month. Data presented are for 95% equal-tailed credible intervals|||2.04|-4.77|0.78
71895200|NCT01287117|143312682|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71895201|NCT01287117|143312683|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.4580
71895202|NCT01287117|143312683|SUPERIORITY_OR_OTHER|||||||0.2087||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.||||0.2087
71895203|NCT01287117|143312683|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (\< median vs ≥ median) and baseline weight (\< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.||||<0.0001
71895204|NCT00538642|143312687|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||<0.05
71895205|NCT02975349|143312705|SUPERIORITY||Lesion rate ratio|1.45||||0.2947|TWO_SIDED|95.0|0.72|2.91|||Negative Binomial model|||||2.91|0.72|0.2947
71895206|NCT02975349|143312705|SUPERIORITY||Lesion rate ratio|0.3||||0.0015|TWO_SIDED|95.0|0.14|0.63|||Negative Binomial model|||||0.63|0.14|0.0015
71809028|NCT02130193|143120033|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.278|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.278
71809029|NCT02130193|143120033|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.138|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.138
71809030|NCT02130193|143120033|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.05|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.05
71809031|NCT02130193|143120033|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.011|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.011
71809032|NCT02130193|143120033|SUPERIORITY_OR_OTHER||Posterior mean difference|1.15|STANDARD_DEVIATION|0.242||0.002|TWO_SIDED|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.63|0.71|0.002
71895207|NCT02975349|143312705|SUPERIORITY||Lesion rate ratio|0.44||||0.0313|TWO_SIDED|95.0|0.21|0.93|||Negative Binomial model|||||0.93|0.21|0.0313
71895208|NCT02975349|143312706|SUPERIORITY||Qualified relapse rate ratio|1.66||||0.2692|TWO_SIDED|95.0|0.67|4.09|||Negative Binomial model|||||4.09|0.67|0.2692
71895209|NCT02975349|143312706|SUPERIORITY||Qualified relapse rate ratio|0.31||||0.0896|TWO_SIDED|95.0|0.08|1.2|||Negative Binomial model|||||1.20|0.08|0.0896
71895210|NCT02975349|143312706|SUPERIORITY||Qualified relapse rate ratio|0.23||||0.0633|TWO_SIDED|95.0|0.05|1.09|||Negative Binomial model|||||1.09|0.05|0.0633
71895211|NCT02975349|143312707|SUPERIORITY||Odds Ratio (OR)|0.75||||0.5609|TWO_SIDED|95.0|0.29|1.95|||Logistic model|||||1.95|0.29|0.5609
71895212|NCT02975349|143312707|SUPERIORITY||Odds Ratio (OR)|2.79||||0.0689|TWO_SIDED|95.0|0.92|8.41|||Logistic model|||||8.41|0.92|0.0689
71895213|NCT02975349|143312707|SUPERIORITY||Odds Ratio (OR)|2.08||||0.1767|TWO_SIDED|95.0|0.72|5.99|||Logistic model|||||5.99|0.72|0.1767
71895214|NCT02975349|143312708|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.407|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.4070
71895215|NCT02975349|143312708|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.5829|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.5829
71809033|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.62|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.62
71895216|NCT02975349|143312708|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.2732|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank-sum test|||||0.00|0.00|0.2732
71895217|NCT02975349|143312720|SUPERIORITY||Lesion rate ratio|1.36||||0.3676|TWO_SIDED|95.0|0.7|2.65|||Negative Binomial|||||2.65|0.70|0.3676
71809034|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.64|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.64
71809035|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.81|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.81
71809036|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.77|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.77
71809037|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.71|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.71
71895218|NCT02975349|143312720|SUPERIORITY||Lesion rate ratio|0.27||||0.0005|TWO_SIDED|95.0|0.13|0.57|||Negative Binomial|||||0.57|0.13|0.0005
71895219|NCT02975349|143312720|SUPERIORITY||Lesion rate ratio|0.41||||0.0157|TWO_SIDED|95.0|0.2|0.85|||Negative Binomial|||||0.85|0.20|0.0157
71895220|NCT02975349|143312721|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9731|TWO_SIDED|95.0|-0.25|0.25|||Wilcoxon rank-sum test|||||0.25|-0.25|0.9731
71895221|NCT02975349|143312721|SUPERIORITY||Hodges-Lehmann estimate|-0.25||||0.0017|TWO_SIDED|95.0|-0.5|0.0|||Wilcoxon rank-sum test|||||0.00|-0.50|0.0017
71895222|NCT02975349|143312721|SUPERIORITY||Hodges-Lehmann estimate|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.25|||Wilcoxon rank-sum test|||||-0.25|-0.75|< 0.0001
71895223|NCT02975349|143312722|SUPERIORITY||Lesion Rate ratio|1.29||||0.4807|TWO_SIDED|95.0|0.63|2.65|||Negative Binomial|||||2.65|0.63|0.4807
71895224|NCT02975349|143312722|SUPERIORITY||Lesion Rate ratio|0.5||||0.062|TWO_SIDED|95.0|0.24|1.04|||Negative Binomial|||||1.04|0.24|0.0620
71895225|NCT02975349|143312722|SUPERIORITY||Lesion Rate ratio|0.42||||0.0189|TWO_SIDED|95.0|0.2|0.87|||Negative Binomial|||||0.87|0.20|0.0189
71895226|NCT02975349|143312723|SUPERIORITY||Difference in least squares means|0.02||||0.8776|TWO_SIDED|95.0|-0.24|0.28|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||0.28|-0.24|0.8776
71895227|NCT02975349|143312723|SUPERIORITY||Difference in least squares means|-0.41||||0.0019|TWO_SIDED|95.0|-0.66|-0.15|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.15|-0.66|0.0019
71895228|NCT02975349|143312723|SUPERIORITY||Difference in least squares means|-0.36||||0.0063|TWO_SIDED|95.0|-0.62|-0.1|||Mixed Effect Model for Repeat Measures||Difference in least squares means of change from baseline in cube root of volume measured in centimeter.|||-0.10|-0.62|0.0063
71895229|NCT02975349|143312724|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9315|TWO_SIDED|95.0|-0.004|0.009|||Wilcoxon rank-sum test|||||0.009|-0.004|0.9315
71895230|NCT02975349|143312724|SUPERIORITY||Hodges-Lehmann estimate|-0.014||||0.0008|TWO_SIDED|95.0|-0.05|0.0|||Wilcoxon rank-sum test|||||0.000|-0.050|0.0008
71895231|NCT02975349|143312724|SUPERIORITY||Hodges-Lehmann estimate|-0.018||||0.0014|TWO_SIDED|95.0|-0.042|0.0|||Wilcoxon rank-sum test|||||0.000|-0.042|0.0014
71895232|NCT02082184|143312754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.114||0.8222|TWO_SIDED||||||ANCOVA|||||||0.8222
71895233|NCT02082184|143312755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7925|TWO_SIDED||||||ANCOVA|||||||0.7925
71895234|NCT02082184|143312756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<70 mg/dL||||<0.001
71895235|NCT02082184|143312756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.068||0.0014|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \<55 mg/dL||||0.0014
71895236|NCT02082184|143312757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.065||0.0164|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<70 mg/dL||||0.0164
71809038|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.7|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.70
71809039|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.74|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.74
71809040|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.79|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.79
71809041|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.77|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.77
71809042|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.9|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.90
71809043|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.66|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.66
71809044|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.74|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.74
71809045|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.43|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.43
71843414|NCT05155306|143200429|OTHER||Geometric mean ratio [%]|202.6|||||TWO_SIDED|90.0|179.6|228.5|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.072.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||228.5|179.6|
71843415|NCT05155306|143200429|OTHER||Geometric mean ratio [%]|172.3|||||TWO_SIDED|90.0|158.2|187.7|||||Ratio is calculated as fed/fasted. Geometric Standard Error = 1.050.|Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||187.7|158.2|
71843416|NCT05601882|143200430|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|11.0|||<|0.0001|TWO_SIDED|95.0|6.6|15.5|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||15.5|6.6|<0.0001
71843417|NCT05601882|143200431|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.4|||<|0.0001|TWO_SIDED|95.0|12.5|24.2|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||24.2|12.5|<0.0001
71895237|NCT02082184|143312757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.0017|TWO_SIDED||||||ANCOVA|||Statistical analysis of frequency of episodes \<55 mg/dL||||0.0017
71843418|NCT05601882|143200432|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.7|||<|0.0001|TWO_SIDED|95.0|9.4|20.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||20.0|9.4|<0.0001
71895238|NCT02082184|143312758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.63||0.597|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>180 mg/dL||||0.5970
71809046|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.45|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.45
71895239|NCT02082184|143312758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8729|TWO_SIDED||||||ANCOVA|||Statistical analysis of time spent \>240 mg/dL||||0.8729
71809047|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.67|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.67
71895240|NCT02082184|143312761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.6075|TWO_SIDED||||||ANCOVA|||Perceived frequency of hyperglycaemia||||0.6075
71895241|NCT02082184|143312761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2295|TWO_SIDED||||||ANCOVA|||Perceived frequency of hypoglycaemia||||0.2295
71809048|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.62|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.62
71809049|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.55|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.55
71809050|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.55|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.55
71809051|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.59|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.59
71809052|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.65|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.65
71809053|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.63|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.63
71809054|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.81|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.81
71809055|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.52|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.52
71809056|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.6|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.60
71843419|NCT05601882|143200433|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|16.6|||<|0.0001|TWO_SIDED|95.0|10.2|23.0|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.0|10.2|<0.0001
71843420|NCT05601882|143200434|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|13.2|||<|0.0001|TWO_SIDED|95.0|9.6|16.9|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||16.9|9.6|<0.0001
71843421|NCT05601882|143200435|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|6.4|||<|0.0001|TWO_SIDED|95.0|3.8|9.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||9.1|3.8|<0.0001
71895242|NCT02082184|143312761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED||||||ANCOVA|||Total treatment satisfaction score||||<0.001
71895243|NCT00537940|143312767|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.8708|TWO_SIDED|95.0|-6.0|7.0|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between Baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.||7.0|-6.0|0.8708
71895244|NCT00537940|143312768|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.662|TWO_SIDED|95.0|0.635|1.335|||Regression, Logistic|||The odds ratio and its 95% CI are calculated by exponentiating the log odds ratio and 95% CI that correspond to the treatment contrast in the logistic regression model with treatment as fixed effect and Baseline term and country as covariate. All statistical tests for secondary efficacy parameters were two sided and performed at significance level of α = 0.05. The above statistical analysis applies to All Partial Seizures - FAS Population.||1.335|0.635|0.662
71809057|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.24|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.24
71895245|NCT00537940|143312769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9232|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9232
71895246|NCT00537940|143312769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6361|TWO_SIDED|||||Simple Partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6361
71895247|NCT00537940|143312769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9075|TWO_SIDED|||||Complex partial: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.9075
71895248|NCT00537940|143312769|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4203|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4203
71895249|NCT00537940|143312770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5069|TWO_SIDED|||||All partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.5069
71895250|NCT00537940|143312770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4721|TWO_SIDED|||||Simple partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.4721
71809058|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.28|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.28
71809059|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.5|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.50
71843422|NCT05601882|143200436|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.4|18.8|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||18.8|9.4|<0.0001
71843423|NCT05601882|143200437|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|18.6|||<|0.0001|TWO_SIDED|95.0|13.9|23.3|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||23.3|13.9|<0.0001
71843424|NCT05601882|143200438|SUPERIORITY|Analyzed using Cochran-Mantel-Haenszel (CMH) test stratified by Validated Investigator's Global Assessment for Atopic Dermatitis categories \[(vIGA-AD (moderate \[3\] versus severe \[4\])\] and age (12 to \< 18; 18 to \< 40; ≥40 to \< 64 years)|Adjusted Response Rate Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.4|13.1|||Cochran-Mantel-Haenszel||Response rate difference = Upadacitinib (Period 1) - Dupilumab (Period 1)|Upadacitinib (Period 1) vs Dupilumab (Period 1)||13.1|5.4|<0.0001
71843425|NCT00115934|143200476|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-10.1||||0.013||95.0|-17.8|-2.4|||Fisher Exact||The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.|The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.||-2.4|-17.8|0.013
71843426|NCT00115934|143200477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Log Rank|||||||0.06
71843427|NCT00115934|143200478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.09
71843428|NCT00115934|143200479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.009
71895251|NCT00537940|143312770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6054|TWO_SIDED|||||Complex partial seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6054
71809060|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.43|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.43
71843429|NCT00115934|143200480|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.07
71843430|NCT00115934|143200481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
71843431|NCT00115934|143200482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test||||0.004
71843432|NCT00115934|143200483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.10
71895252|NCT00537940|143312770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6603|TWO_SIDED|||||SGTC seizure: p-value was calculated from the 2-sided Fisher's exact test.|Fisher Exact|||||||0.6603
71895253|NCT00537940|143312772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1881|TWO_SIDED|||||p-value is calculated using Fisher Exact Test.|Fisher Exact|||||||0.1881
71895254|NCT00537940|143312773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.38||0.5643|TWO_SIDED|95.0|-0.53|0.97|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and and country as covariates.||0.97|-0.53|0.5643
71895255|NCT00537940|143312773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.32||0.7712|TWO_SIDED|95.0|-0.73|0.54|||ANCOVA|||Change at Week 21 / ET , HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country as covariates.||0.54|-0.73|0.7712
71809061|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.37|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.37
71676206|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.49||0.65|TWO_SIDED|95.0|-0.74|1.19||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.19|-0.74|0.65
71676207|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.71||0.3|TWO_SIDED|95.0|-0.66|2.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.11|-0.66|0.30
71809062|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.38|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.38
71809063|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.43|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.43
71809064|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.51|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.51
71843433|NCT00115934|143200484|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71843434|NCT00115934|143200485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
71843435|NCT00115934|143200486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
71843436|NCT00115934|143200487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||95.0|||||t-test, 2 sided|||||||0.54
71843437|NCT00115934|143200488|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71843438|NCT00115934|143200489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Poisson regression|The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.||||||0.003
71843439|NCT00115934|143200490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.20
71843440|NCT00115934|143200491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.002
71843441|NCT00115934|143200492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Poisson regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.||||||0.03
71843442|NCT04977583|143200493|SUPERIORITY||Odds Ratio (OR)|1.138|STANDARD_ERROR_OF_MEAN|0.2625||0.6243|TWO_SIDED|95.0|0.679|1.904|||Mixed Models Analysis|||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.904|0.679|0.6243
71843443|NCT04977583|143200493|SUPERIORITY||Odds Ratio (OR)|1.497|STANDARD_ERROR_OF_MEAN|0.2553||0.1146|TWO_SIDED|95.0|0.908|2.469|||Mixed Models Analysis|||This test compares Arm 1 (screening) to arm 3 (assistance)||2.469|0.908|0.1146
71843444|NCT04977583|143200494|SUPERIORITY||Risk Ratio (RR)|0.963|STANDARD_ERROR_OF_MEAN|0.2078||0.856|TWO_SIDED|95.0|0.641|1.447|||Poisson|We used total needs as an offset||This test is comparing Arm 1 (screening) to Arm 2 (awareness)||1.447|0.641|0.856
71843445|NCT04977583|143200494|SUPERIORITY||Risk Ratio (RR)|1.136|STANDARD_ERROR_OF_MEAN|0.1999||0.5248|TWO_SIDED|95.0|0.768|1.681|||Poisson|||This test is comparing Arm 1 (screening) to Arm 3 (assistance)||1.681|0.768|0.5248
71843446|NCT04977583|143200495|SUPERIORITY||Odds Ratio (OR)|0.866|STANDARD_ERROR_OF_MEAN|0.22||0.5582|TWO_SIDED|95.0|0.536|1.4|||Regression, Logistic|||This is Arm 1 compared to Arm 2||1.400|0.536|.5582
71843447|NCT04977583|143200495|SUPERIORITY||Odds Ratio (OR)|0.854|STANDARD_ERROR_OF_MEAN|0.217||0.5196|TWO_SIDED|95.0|0.528|1.381|||Regression, Logistic|||This is Arm 1 compared to Arm 3||1.381|0.528|0.5196
71843448|NCT04977583|143200496|SUPERIORITY||Odds Ratio (OR)|1.42|STANDARD_ERROR_OF_MEAN|0.2794||0.2105|TWO_SIDED|95.0|0.821|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.821|0.2105
71843449|NCT04977583|143200496|SUPERIORITY||Odds Ratio (OR)|0.7944|STANDARD_ERROR_OF_MEAN|0.2816||0.4143|TWO_SIDED|95.0|0.4574|1.379|||ANOVA|||This is arm 1 compared to arm 3||1.379|0.4574|.4143
71843450|NCT04977583|143200497|SUPERIORITY||Odds Ratio (OR)|0.9995|STANDARD_ERROR_OF_MEAN|0.0171||0.9775|TWO_SIDED|95.0|0.9665|1.0336|||ANOVA|||This arm 1 compared to arm 2||1.0336|0.9665|0.9775
71843451|NCT04977583|143200497|SUPERIORITY||Odds Ratio (OR)|1.017|STANDARD_ERROR_OF_MEAN|0.0176||0.3194|TWO_SIDED|95.0|0.9832|1.0534|||ANOVA|||This arm 1 compared to arm 3||1.0534|0.9832|0.3194
71843452|NCT04977583|143200498|SUPERIORITY||Odds Ratio (OR)|1.0284|STANDARD_ERROR_OF_MEAN|0.1613||0.8623|TWO_SIDED|95.0|0.7497|1.4107|||ANOVA|||This is arm 1 compared to arm 2||1.4107|0.7497|0.8623
71843453|NCT04977583|143200498|SUPERIORITY||Odds Ratio (OR)|1.3701|STANDARD_ERROR_OF_MEAN|0.1626||0.0534|TWO_SIDED|95.0|0.9962|1.8844|||ANOVA|||This is arm 1 compared to arm 3||1.8844|0.9962|0.0534
71676208|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.75||0.78|TWO_SIDED|95.0|-1.68|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.26|-1.68|0.78
71676209|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|0.69||0.03|TWO_SIDED|95.0|0.12|2.83||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.83|0.12|0.03
71677354|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.235|||||TWO_SIDED|95.0|0.178|0.31||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.310|0.178|
71809065|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.5|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.50
71809066|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.7|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.70
71809067|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.38|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.38
71809068|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.45|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.45
71809069|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.57|STANDARD_DEVIATION|2.04||0.11|TWO_SIDED|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals|||3.23|-4.55|0.11
71809070|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.72|STANDARD_DEVIATION|2.21||0.15|TWO_SIDED|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals|||3.60|-5.03|0.15
71809071|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.99|STANDARD_DEVIATION|2.29||0.32|TWO_SIDED|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals|||2.27|-6.60|0.32
71809072|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.64|STANDARD_DEVIATION|2.31||0.28|TWO_SIDED|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals|||3.07|-5.92|0.28
71809073|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.3|STANDARD_DEVIATION|2.4||0.23|TWO_SIDED|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals|||3.55|-5.70|0.23
71809074|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.31|STANDARD_DEVIATION|2.42||0.24|TWO_SIDED|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals|||3.05|-6.46|0.24
71676210|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|-1.92|2.04||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.04|-1.92|0.95
71809075|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.6|STANDARD_DEVIATION|2.45||0.29|TWO_SIDED|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals|||2.90|-6.75|0.29
71809076|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.63||0.36|TWO_SIDED|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals|||3.30|-6.93|0.36
71809077|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.92|STANDARD_DEVIATION|2.63||0.35|TWO_SIDED|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals|||3.18|-7.04|0.35
71809078|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-3.44|STANDARD_DEVIATION|2.72||0.57|TWO_SIDED|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals|||1.87|-8.74|0.57
71809079|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.16|STANDARD_DEVIATION|2.72||0.25|TWO_SIDED|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals|||4.20|-6.20|0.25
71809080|NCT02130193|143120034|SUPERIORITY_OR_OTHER||Posterior mean difference|-1.73|STANDARD_DEVIATION|2.7||0.32|TWO_SIDED|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals|||3.45|-6.91|0.32
71809081|NCT02130193|143120035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.477|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 1.0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.477
71809082|NCT02130193|143120035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.343|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.9 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.343
71809083|NCT02130193|143120035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.221|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.8 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.221
71809084|NCT02130193|143120035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.116|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.116
71809085|NCT02130193|143120035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.052|TWO_SIDED|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.6 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||1.82|0.55|0.052
71809086|NCT02130193|143120036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.212|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.212
71843454|NCT04977583|143200499|SUPERIORITY||Odds Ratio (OR)|2.298|STANDARD_ERROR_OF_MEAN|1.464||0.5701|TWO_SIDED|95.0|0.1304|40.5121|||ANOVA|||This is arm 1 compared to arm 2||40.5121|0.1304|0.5701
71843455|NCT04977583|143200499|SUPERIORITY||Odds Ratio (OR)|4.56|STANDARD_ERROR_OF_MEAN|1.467||0.3016|TWO_SIDED|95.0|0.2571|80.8746|||ANOVA|||This is arm 1 compared to arm 3||80.8746|0.2571|0.3016
71843456|NCT04977583|143200500|SUPERIORITY||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.2438||0.087|TWO_SIDED|95.0|0.944|2.454|||ANOVA|||This is arm 1 compared to arm 2||2.454|0.944|0.0870
71843457|NCT04977583|143200500|SUPERIORITY||Odds Ratio (OR)|1.85|STANDARD_ERROR_OF_MEAN|0.2897||0.0354|TWO_SIDED|95.0|1.048|3.264|||ANOVA|||This is arm 1 compared to arm 3||3.264|1.048|0.0354
71843458|NCT04977583|143200501|SUPERIORITY||Odds Ratio (OR)|0.618|STANDARD_ERROR_OF_MEAN|0.333||0.3063|TWO_SIDED|95.0|0.246|1.553|||ANOVA|||This is arm 1 compared to arm 2||1.553|0.246|0.3063
71843459|NCT04977583|143200501|SUPERIORITY||Odds Ratio (OR)|0.679|STANDARD_ERROR_OF_MEAN|0.3946||0.4378|TWO_SIDED|95.0|0.256|1.803|||ANOVA|||This is arm 1 compared to arm 3||1.803|.256|.4378
71843460|NCT04977583|143200502|SUPERIORITY||Odds Ratio (OR)|0.5083|STANDARD_ERROR_OF_MEAN|0.8265||0.4134|TWO_SIDED|95.0|0.1006|2.5687|||ANOVA|||This is arm 1 compared to arm 2||2.5687|0.1006|0.4134
71843461|NCT04977583|143200502|SUPERIORITY||Odds Ratio (OR)|1.819|STANDARD_ERROR_OF_MEAN|0.8283||0.4705|TWO_SIDED|95.0|0.3588|9.223|||ANOVA|||This is arm 1 compared to arm 3||9.2230|0.3588|0.4705
71843462|NCT04977583|143200503|SUPERIORITY||Odds Ratio (OR)|1.765|STANDARD_ERROR_OF_MEAN|0.2684||0.0347|TWO_SIDED|95.0|1.044|2.987|||Mixed Models Analysis||This analysis is arm 1 compared to arm 3. Arm 3 is the numerator and arm 1 is the denominator.|||2.987|1.044|0.0347
71809087|NCT02130193|143120036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.111|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.111
71809088|NCT02130193|143120036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.049|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.049
71809089|NCT02130193|143120036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.012|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.012
71809090|NCT02130193|143120036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.001|TWO_SIDED|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals|||2.11|0.73|0.001
71809091|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.64|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.64
71809092|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.75|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.75
71809093|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.77|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.77
71809094|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.74|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.74
71809095|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.67|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.67
71809096|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.69|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.69
71809097|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.72|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.72
71809098|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.71|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.71
71809099|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.66|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.66
71809100|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.84|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.84
71809101|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.65|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.65
71809102|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.71|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.71
71809103|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.13|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.13
71809104|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.27|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.27
71676211|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.09||0.48|TWO_SIDED|95.0|-2.91|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|-2.91|0.48
71676212|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.0||0.37|TWO_SIDED|95.0|-2.86|1.07||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.07|-2.86|0.37
71676213|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.73|STANDARD_ERROR_OF_MEAN|0.31||0.0192|TWO_SIDED|95.0|0.12|1.34||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.34|0.12|0.0192
71809105|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.31|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.31
71809106|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.29|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.29
71809107|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.23|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.23
71809108|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.26|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.26
71809109|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.28|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.28
71809110|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.29|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.29
71809111|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.23|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.23
71809112|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.45|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.45
71843463|NCT04977583|143200504|SUPERIORITY||Odds Ratio (OR)|1.734|STANDARD_ERROR_OF_MEAN|0.3489||0.116|TWO_SIDED|95.0|0.875|3.436|||Mixed Models Analysis||This analysis compares arm 1 to arm 2. Arm 2 is the numerator and Arm 1 is the denominator|||3.436|0.875|0.1160
71843464|NCT04977583|143200504|SUPERIORITY||Odds Ratio (OR)|2.376|STANDARD_ERROR_OF_MEAN|0.3475||0.0134|TWO_SIDED|95.0|1.202|4.695|||Mixed Models Analysis|||||4.695|1.202|0.0134
71843465|NCT04977583|143200505|SUPERIORITY||Odds Ratio (OR)|5.006|STANDARD_ERROR_OF_MEAN|0.617||0.0094|TWO_SIDED|95.0|1.512|16.57|||Mixed Models Analysis||This analysis is arm 1 compared to compared to arm 3. Arm 3 is the numerator and arm 1 is denominator.|||16.570|1.512|0.0094
71843466|NCT04977583|143200505|SUPERIORITY||Odds Ratio (OR)|1.875|STANDARD_ERROR_OF_MEAN|0.6532||0.3377|TWO_SIDED|95.0|0.521|6.746|||Mixed Models Analysis||This is a comparison of arm 1 and arm 2. Arm 2 is the numerator and arm 1 is the denominator.|||6.746|0.521|0.3377
71843467|NCT03373916|143200510|OTHER|||||||0.58|||||||Chi-squared|||||||0.58
71843468|NCT03373916|143200511|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71809113|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.24|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.24
71809114|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.28|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.28
71809115|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.23|STANDARD_DEVIATION|0.72||0.26|TWO_SIDED|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals|||1.25|-1.53|0.26
71809116|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.78||0.41|TWO_SIDED|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals|||1.10|-1.91|0.41
71809117|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.6|STANDARD_DEVIATION|0.8||0.46|TWO_SIDED|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.98|-2.09|0.46
71809118|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.55|STANDARD_DEVIATION|0.81||0.43|TWO_SIDED|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.87|-2.23|0.43
71809119|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.83||0.36|TWO_SIDED|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals|||1.27|-1.88|0.36
71809120|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.86||0.39|TWO_SIDED|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals|||1.26|-1.99|0.39
71809121|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.85||0.42|TWO_SIDED|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals|||1.08|-2.10|0.42
71809122|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.5|STANDARD_DEVIATION|0.87||0.42|TWO_SIDED|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals|||1.14|-2.11|0.42
71809123|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.34|STANDARD_DEVIATION|0.88||0.35|TWO_SIDED|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals|||1.23|-2.14|0.35
71809124|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.89|STANDARD_DEVIATION|0.89||0.58|TWO_SIDED|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-2.71|0.58
71809125|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.36|STANDARD_DEVIATION|0.91||0.36|TWO_SIDED|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals|||1.41|-2.15|0.36
71809126|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.9||0.41|TWO_SIDED|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals|||1.13|-2.36|0.41
71809127|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.66|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.66
71809128|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.66|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.66
71809129|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.91|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.91
71843469|NCT03373916|143200512|OTHER|||||||0.18|||||||Chi-squared|||||||0.18
71843470|NCT03373916|143200513|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71843471|NCT03373916|143200514|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71676214|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|0.45||0.186|TWO_SIDED|95.0|-1.48|0.29||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.29|-1.48|0.1860
71676215|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.44||0.3863|TWO_SIDED|95.0|-0.49|1.26||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.26|-0.49|0.3863
71676216|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.571|TWO_SIDED|95.0|-0.89|1.61||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.61|-0.89|0.5710
71809130|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.79|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.79
71809131|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.84|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.84
71809132|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.81|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.81
71843472|NCT04098575|143200533|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71809133|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.76|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.76
71809134|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.84|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.84
71809135|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.83|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.83
71809136|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.94|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.94
71809137|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.84|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.84
71843473|NCT04098575|143200534|OTHER|||||||0.835|||||||Chi-squared|||||||0.835
71843474|NCT04098575|143200535|OTHER||||||<|0.001|||||||Chi-squared|||Antihypertensive drugs||||<0.001
71843475|NCT04098575|143200535|OTHER||||||<|0.001|||||||Chi-squared|||Lipid-lowering agents||||<0.001
71843476|NCT04098575|143200535|OTHER||||||<|0.001|||||||Chi-squared|||Antiplatelet, anticoagulant drugs||||<0.001
71843477|NCT04098575|143200535|OTHER||||||<|0.001|||||||Chi-squared|||Glucose-lowering therapies||||<0.001
71843478|NCT04098575|143200536|OTHER||||||<|0.001|||||||Chi-squared|||Group: \< 65||||<0.001
71843479|NCT04098575|143200536|OTHER|||||||0.001|||||||Chi-squared|||Group: 65 ≤ 75||||0.001
71843480|NCT04098575|143200536|OTHER||||||<|0.001|||||||Chi-squared|||Group: 75 - 80||||<0.001
71843481|NCT04098575|143200536|OTHER||||||<|0.002|||||||Chi-squared|||Group: \> 80||||<0.002
71843482|NCT04098575|143200537|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71843483|NCT04098575|143200538|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71809138|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.81|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.81
71809139|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.01
71809140|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.02|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.02
71809141|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.15|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.15
71809142|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.05|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.05
71809143|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.08|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.08
71809144|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.08|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.08
71809145|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.06|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.06
71809146|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.14|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.14
71809147|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.14|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.14
71809148|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.29|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.29
71809149|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.15|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.15
71809150|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.13|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.13
71809151|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.14|STANDARD_DEVIATION|0.35||0.06|TWO_SIDED|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.84|0.06
71843484|NCT04098575|143200539|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71843485|NCT04098575|143200540|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
71843486|NCT04098575|143200541|OTHER|||||||0.475|||||||Wilcoxon rank sum test|||||||0.475
71843487|NCT04098575|143200542|OTHER||||||<|0.001|||||||Chi-squared|||Insulin||||<0.001
71843488|NCT04098575|143200542|OTHER||||||<|0.001|||||||Chi-squared|||Metformin||||<0.001
71843489|NCT04098575|143200542|OTHER|||||||0.157|||||||Chi-squared|||Acarbose||||0.157
71843490|NCT04098575|143200542|OTHER||||||<|0.001|||||||Chi-squared|||Sulfonylurea||||<0.001
71843491|NCT04098575|143200542|OTHER|||||||0.071|||||||Chi-squared|||Dipeptidyl peptidase-4 (DPP-4) inhibitors||||0.071
71843492|NCT04098575|143200542|OTHER|||||||0.317|||||||Chi-squared|||Glucagon-like peptide-1 (GLP-1) agonists||||0.317
71843493|NCT04098575|143200542|OTHER||||||<|0.001|||||||Chi-squared|||Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin||||<0.001
71843494|NCT04098575|143200543|OTHER||||||<|0.002|||||||Chi-squared|||||||<0.002
71843495|NCT04098575|143200546|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.000
71895256|NCT00537940|143312773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.35||0.4236|TWO_SIDED|95.0|-0.41|0.97|||Ranked ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.97|-0.41|0.4236
71895257|NCT00537940|143312773|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.29||0.5492|TWO_SIDED|95.0|-0.75|0.4|||Ranked ANCOVA|||Change at Week 21/ET, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment1difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.||0.40|-0.75|0.5492
71895258|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|2.07||0.116|TWO_SIDED|95.0|-0.81|7.31|||ANCOVA|||Baseline Sleep disturbance: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||7.31|-0.81|0.1160
71895259|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.68||0.849|TWO_SIDED|95.0|-3.62|2.98|||ANCOVA|||Week 21 Sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.98|-3.62|0.8490
71895260|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|2.82||0.6728|TWO_SIDED|95.0|-4.34|6.73|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.73|-4.34|0.6728
71895261|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3954|TWO_SIDED|95.0|-2.56|6.47|||ANCOVA|||Week 21 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.47|-2.56|0.3954
71895262|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|4.03|STANDARD_ERROR_OF_MEAN|2.52||0.1106|TWO_SIDED|95.0|-0.92|8.98|||ANCOVA|||Baseline Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||8.98|-0.92|0.1106
71895263|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|2.11||0.3603|TWO_SIDED|95.0|-6.09|2.22|||ANCOVA|||Week 21 Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.22|-6.09|0.3603
71809152|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.17|STANDARD_DEVIATION|0.39||0.09|TWO_SIDED|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-0.94|0.09
71809153|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.56|STANDARD_DEVIATION|0.43||0.37|TWO_SIDED|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.46|0.37
71809154|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.41||0.18|TWO_SIDED|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.44|-1.16|0.18
71843496|NCT05274321|143200547|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.22||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.22
71843497|NCT05274321|143200548|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval. .||||||0.02||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.02
71895264|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.14||0.8312|TWO_SIDED|95.0|-0.3|0.24|||ANCOVA|||Baseline Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.24|-0.30|0.8312
71895265|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.38|0.42|||ANCOVA|||Week 21 Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||0.42|-0.38|0.9101
71895266|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|2.45||0.3346|TWO_SIDED|95.0|-7.19|2.45|||ANCOVA|||Baseline Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.45|-7.19|0.3346
71843498|NCT05274321|143200549|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.03||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.03
71843499|NCT05274321|143200550|NON_INFERIORITY|The noninferiority margin was determined by taking 10% of the standard of care change score. Noninferiority was determined for each outcome if the noninferiority margin did not overlap with the regression coefficient's 95% confidence interval.||||||0.25||||||Wald P values were calculated by testing whether the regression coefficient met or exceeded the noninferiority margin.|Regression, Linear|The threshold for significance is 0.0167.||Absolute between-eye differences were calculated for each participant by subtracting the standard of care (SOC) change score from the Nanodropper change score. The confidence interval (CI) is 95%.||||0.25
71809155|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.4|STANDARD_DEVIATION|0.42||0.24|TWO_SIDED|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.41|-1.24|0.24
71843500|NCT01105975|143200551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.5|||<|0.001|TWO_SIDED|90.0|64.9|92.1|||mixed model repeated measures (MMRM)|||||92.1|64.9|<0.001
71809156|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.44||0.24|TWO_SIDED|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.47|-1.23|0.24
71843501|NCT01105975|143200552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9||||0.002|TWO_SIDED|90.0|-21.2|-6.7|||mixed model repeated measures (MMRM)|||||-6.7|-21.2|0.002
71843502|NCT01105975|143200553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|56.7|||<|0.001|TWO_SIDED|90.0|43.6|69.8|||mixed model repeated measures (MMRM)|||||69.8|43.6|<0.001
71843503|NCT01105975|143200553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|97.6|||<|0.001||90.0|84.5|110.8|||mixed model repeated measures (MMRM)|||||110.8|84.5|<0.001
71677355|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.177|||||TWO_SIDED|95.0|0.134|0.234||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.234|0.134|
71809157|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.32|STANDARD_DEVIATION|0.44||0.19|TWO_SIDED|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.56|-1.14|0.19
71843504|NCT01105975|143200553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|131.9|||<|0.001|TWO_SIDED|90.0|118.5|145.2|||mixed model repeated measures (MMRM)|||||145.2|118.5|<0.001
71843505|NCT01105975|143200554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|90.0|-24.6|-10.5|||mixed model repeated measures (MMRM)|||||-10.5|-24.6|<0.001
71843506|NCT01105975|143200554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.2|||<|0.001|TWO_SIDED|90.0|-33.2|-19.2|||mixed model repeated measures (MMRM)|||||-19.2|-33.2|<0.001
71843507|NCT01105975|143200554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.8|||<|0.001|TWO_SIDED|90.0|-47.0|-32.7|||mixed model repeated measures (MMRM)|||||-32.7|-47.0|<0.001
71843508|NCT01105975|143200555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.3|||<|0.001||90.0|66.2|92.4|||mixed model repeated measures (MMRM)|||||92.4|66.2|<0.001
71843509|NCT01105975|143200555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.5|||<|0.001|TWO_SIDED|90.0|75.2|101.8|||mixed model repeated measures (MMRM)|||||101.8|75.2|<0.001
71843510|NCT01105975|143200556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2||||0.009|TWO_SIDED|90.0|-18.3|-4.2|||mixed model repeated measures (MMRM)|||||-4.2|-18.3|0.009
71843511|NCT01105975|143200556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5||||0.002|TWO_SIDED|90.0|-20.6|-6.4|||mixed model repeated measures (MMRM)|||||-6.4|-20.6|0.002
71843512|NCT00195403|143200591|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in PGA at Month 3 was evaluated using paired t-test.||||<0.0001
71843513|NCT00195403|143200592|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.||||<0.0001
71843514|NCT05288348|143200605|SUPERIORITY||Mean Difference (Final Values)|2.57||||0.56|TWO_SIDED|95.0|-6.19|11.33||unadjusted|Mixed Models Analysis|Mixed methods ANOVA||||11.33|-6.19|0.56
71843515|NCT05288348|143200605|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.92|TWO_SIDED|95.0|-10.5|9.48|||Mixed Models Analysis|Mixed methods ANOVA||Adjusted for age, sex, respiratory rate and injury type||9.48|-10.5|0.92
71843516|NCT05288348|143200606|SUPERIORITY||Mean Difference (Final Values)|-7.14||||0.18|TWO_SIDED|95.0|-17.66|3.37|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60min||3.37|-17.66|0.18
71843517|NCT05288348|143200606|SUPERIORITY||Median Difference (Final Values)|2.92||||0.63|TWO_SIDED|95.0|-9.3|15.1|||Mixed Models Analysis|Mixed effects ANOVA||VNRS @ 60 min Adjusted for sex and injury type||15.10|-9.30|0.63
71809158|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.48|STANDARD_DEVIATION|0.48||0.32|TWO_SIDED|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.43|0.32
71809159|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.46|STANDARD_DEVIATION|0.49||0.32|TWO_SIDED|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.38|-1.49|0.32
71676217|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.68||0.2797|TWO_SIDED|95.0|-2.06|0.6||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.60|-2.06|0.2797
71809160|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.73|STANDARD_DEVIATION|0.49||0.52|TWO_SIDED|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.20|-1.68|0.52
71809161|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.49|STANDARD_DEVIATION|0.5||0.33|TWO_SIDED|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.48|-1.45|0.33
71809162|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.43|STANDARD_DEVIATION|0.5||0.29|TWO_SIDED|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.55|-1.36|0.29
71809163|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.43|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.43
71809164|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.29|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.29
71809165|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.7|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.70
71809166|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.71|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.71
71809167|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.61|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.61
71809168|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.48|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.48
71809169|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.58|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.58
71809170|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.83|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.83
71809171|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.74|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.74
71809172|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.89|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.89
71843518|NCT05288348|143200606|SUPERIORITY||Mean Difference (Final Values)|-10.59||||0.08|TWO_SIDED|95.0|-22.39|1.21||Unadjusted|Mixed Models Analysis|||VNRS @ 90 min||1.21|-22.39|0.08
71809173|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.59|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.59
71809174|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.77|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.77
71843519|NCT05288348|143200606|SUPERIORITY||Mean Difference (Final Values)|7.36||||0.28|TWO_SIDED|95.0|-6.13|20.8|||Mixed Models Analysis|Mixed Method ANOVA|Adjusted for ISS|VNRS @90min adjusted||20.80|-6.13|0.28
71843520|NCT05288348|143200606|SUPERIORITY||Mean Difference (Final Values)|-9.52||||0.18|TWO_SIDED|95.0|-23.6|4.56|||Mixed Models Analysis|||VNRS @ 120 min||4.56|-23.60|0.18
71843521|NCT05288348|143200606|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.5|TWO_SIDED|95.0|-20.7|10.2|||Mixed Models Analysis|Mixed Method ANOVA||VNRS @ 120min adjusted for sex, HR, RR, and injury type||10.20|-20.70|0.50
71843522|NCT05288348|143200607|SUPERIORITY|||||||0.005||||||PGA @ 30 min|Chi-squared|||||||0.005
71843523|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|1.45||||0.39|TWO_SIDED|95.0|-4.77|1.89|||General Addative Model|||"SPID 30~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||1.89|-4.77|0.39
71843524|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|1.72||||0.29|TWO_SIDED|95.0|-1.5|4.95|||General Additive Model|||"SPID 30, Adjusted Analysis~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||4.95|-1.50|0.29
71843525|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|0.08||||0.98|TWO_SIDED|95.0|-6.63|6.47|||Generalized Additive Model|||SPID @ 60min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||6.47|-6.63|0.98
71809175|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|0.06|STANDARD_DEVIATION|0.31||0.01|TWO_SIDED|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.59|0.01
71809176|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|0.19|STANDARD_DEVIATION|0.35||0.01|TWO_SIDED|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals|||0.85|-0.53|0.01
71809177|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.2|STANDARD_DEVIATION|0.38||0.09|TWO_SIDED|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-0.94|0.09
71809178|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.21|STANDARD_DEVIATION|0.37||0.09|TWO_SIDED|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals|||0.50|-0.92|0.09
71843526|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|0.61||||0.85|TWO_SIDED|95.0|-5.76|6.98|||Generalized Additive Model|||"SPID 60 Adjusted~Last observed carried forward to address missingness"||6.98|-5.76|0.85
71843527|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|-1.26||||0.8|TWO_SIDED|95.0|-8.75|11.28|||Generalized Additive Model|||SPID @ 90 mn last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||11.28|-8.75|0.8
71843528|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|-0.44||||0.92|TWO_SIDED|95.0|-10.2|9.92|||Generalized Additive Model|||"SPID 90 min Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||9.92|-10.2|0.92
71843529|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|-3.18||||0.64|TWO_SIDED|95.0|-10.45|16.9|||Generalized Additive Model|||SPID @ 120 min last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value||16.90|-10.45|0.64
71843530|NCT05288348|143200608|SUPERIORITY||Odds Ratio (OR)|-2.15||||0.75|TWO_SIDED|95.0|-15.6|11.3|||Generalized Additive Model|||"SPID 120 Adjusted~last observation carried forward (LOCF) imputation technique to fill out the missing values by carrying forward the last observed value"||11.30|-15.60|0.75
71843531|NCT05288348|143200609|SUPERIORITY||z statistic|0.46||||0.64|TWO_SIDED|95.0|-1.96|1.96|||two sided test of proportion|||||1.96|-1.96|0.64
71843532|NCT05288348|143200610|SUPERIORITY||Odds Ratio (OR)|-0.22||||0.61|TWO_SIDED|95.0|-1.11|0.66|||General Additive Models|||||0.66|-1.11|0.61
71843533|NCT05288348|143200610|SUPERIORITY||Odds Ratio (OR)|-0.28||||0.54|TWO_SIDED|95.0|-1.23|0.65|||General Additive Model|||6 item screener adjusted analysis||0.65|-1.23|0.54
71843534|NCT05288348|143200611|SUPERIORITY||Odds Ratio (OR)|2.35||||0.009|TWO_SIDED|95.0|1.24|4.46|||Ordinal Polytomous Logisitic Regression|||Healthcare Professional Global Assessment of method of pain control at 30 min.||4.46|1.24|0.009
71843535|NCT05288348|143200611|SUPERIORITY||Odds Ratio (OR)|2.24||||0.01|TWO_SIDED|95.0|1.18|4.29|||Ordinal polytomous logistic regression|||Healthcare Professional Global Assessment of method of pain control at 30 min. adjusted for ISS and Race||4.29|1.18|0.01
71843536|NCT05288348|143200612|SUPERIORITY||Odds Ratio (OR)|0.97||||0.96|TWO_SIDED|95.0|0.22|4.26|||Regression, Logistic|||||4.26|0.22|0.96
71895267|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|2.05||0.7491|TWO_SIDED|95.0|-4.69|3.37|||ANCOVA|||Week 21 Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||3.37|-4.69|0.7491
71676218|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.62||0.0312|TWO_SIDED|95.0|0.12|2.55||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||2.55|0.12|0.0312
71676219|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.91||0.5086|TWO_SIDED|95.0|-1.19|2.39||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.39|-1.19|0.5086
71809179|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.11|STANDARD_DEVIATION|0.37||0.05|TWO_SIDED|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals|||0.61|-0.82|0.05
71843537|NCT05288348|143200612|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.17|5.04|||||Adjusted for age, sex and SpO2|||5.04|0.17|
71843538|NCT05288348|143200613|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.04|24.92||||||||24.92|0.04|
71843539|NCT05288348|143200613|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.0|14.28|||||Adjusted for Heart Rate and Injury Severity Score|||14.28|0|
71843540|NCT05288348|143200614|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|0.39|8.37||||||||8.37|0.39|
71809180|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|0.02|STANDARD_DEVIATION|0.36||0.02|TWO_SIDED|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.69|0.02
71809181|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.08|STANDARD_DEVIATION|0.36||0.04|TWO_SIDED|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals|||0.62|-0.79|0.04
71809182|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.39|STANDARD_DEVIATION|0.4||0.22|TWO_SIDED|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals|||0.43|-1.12|0.22
71843541|NCT05288348|143200614|SUPERIORITY||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|0.39|8.6|||||Adjusted for SpO2|||8.60|0.39|
71895268|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|1.9||0.1162|TWO_SIDED|95.0|-0.74|6.71|||ANCOVA|||Baseline Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.71|-0.74|0.1162
71895269|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|1.66||0.2163|TWO_SIDED|95.0|-1.21|5.32|||ANCOVA|||Week 21 Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||5.32|-1.21|0.2163
71843542|NCT05288348|143200616|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.02|5.12||||||||5.12|0.02|
71843543|NCT05288348|143200616|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.02|4.56|||||Adjusted for heart rate|||4.56|0.02|
71843544|NCT05288348|143200617|SUPERIORITY||difference of proportion|0.135|||>|0.99|TWO_SIDED||||||Chi-squared|||||||>0.99
71843545|NCT05288348|143200618|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED|95.0|0.69|1.61|||Regression, Cox|||||1.61|0.69|0.90
71843546|NCT05288348|143200618|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.48|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||Adjusted for Race and ISS||1.81|0.75|0.48
71843547|NCT05288348|143200620|SUPERIORITY||Odds Ratio (OR)|0.0||||0.99|TWO_SIDED|95.0|-0.15|0.15|||Non parametric General Addative Model|||||0.15|-0.15|0.99
71843548|NCT05288348|143200620|SUPERIORITY||Odds Ratio (OR)|0.01||||0.96|TWO_SIDED|95.0|-0.16|0.15|||Non Parametric General Additive Model|||Adjusted||0.15|-0.16|0.96
71843549|NCT05288348|143200621|SUPERIORITY||Odds Ratio (OR)|0.01||||0.84|TWO_SIDED|95.0|-0.17|0.16|||Non Parametric General Additive Model|||||0.16|-0.17|0.84
71843550|NCT05288348|143200621|SUPERIORITY||Odds Ratio (OR)|0.02||||0.84|TWO_SIDED|95.0|-0.19|0.16|||Non Parametric Generalized Additive Mode|||Adjusted||0.16|-0.19|0.84
71843551|NCT05288348|143200622|SUPERIORITY||Odds Ratio (OR)|0.02||||0.81|TWO_SIDED|95.0|-0.17|0.22|||Non Parametric Generalized Additive Mode|||||0.22|-0.17|0.81
71843552|NCT05288348|143200622|SUPERIORITY||Odds Ratio (OR)|0.01||||0.91|TWO_SIDED|95.0|-0.2|0.22|||Non Parametric Generalized Additive Mode|||Adjusted||0.22|-0.20|0.91
71843553|NCT05288348|143200623|SUPERIORITY||Odds Ratio (OR)|0.03||||0.74|TWO_SIDED|95.0|-0.25|0.18|||Non Parametric Generalized Additive Mode|||||0.18|-0.25|0.74
71843554|NCT05288348|143200623|SUPERIORITY||Odds Ratio (OR)|0.05||||0.63|TWO_SIDED|95.0|-0.3|0.18|||Non Parametric Generalized Additive Mode|||Adjusted||0.18|-0.30|0.63
71843555|NCT03776812|143200624|OTHER||Hazard Ratio (HR)|0.83||||0.3293|TWO_SIDED|95.0|0.56|1.22|||Cox proportional hazards model|||||1.22|0.56|0.3293
71843556|NCT03776812|143200624|OTHER||Hazard Ratio (HR)|0.66||||0.0384|TWO_SIDED|95.0|0.44|0.98|||Cox proportional hazards model|||||0.98|0.44|0.0384
71843557|NCT02879318|143200648|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.72|TWO_SIDED|90.0|0.71|1.25||a priori threshold for statistical significance was 0.1.|Log Rank|stratified by ECOG performance status and prior adjuvant therapy.||||1.25|0.71|0.72
71843558|NCT02879318|143200649|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.91|TWO_SIDED|90.0|0.75|1.29|||Log Rank|||||1.29|0.75|0.91
71843559|NCT02879318|143200650|SUPERIORITY||Odds Ratio (OR)|1.49||||0.28|TWO_SIDED|90.0|0.81|2.72|||Cochran-Mantel-Haenszel|stratified by ECOG performance status and prior adjuvant chemotherapy||||2.72|0.81|0.28
71843560|NCT04121741|143200651|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.42||0.864|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing video intervention compared to control) is shown. Estimates of FMD% for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.864
71843561|NCT04121741|143200651|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.42||0.913|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for FMD% (singing coach intervention compared to control) is shown. Estimates of FMD% for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.913
71843562|NCT04121741|143200652|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.29|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing video intervention compared to control) is shown. Estimates of RHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.290
71809183|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.26|STANDARD_DEVIATION|0.41||0.14|TWO_SIDED|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals|||0.52|-1.07|0.14
71809184|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.53|STANDARD_DEVIATION|0.43||0.36|TWO_SIDED|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals|||0.29|-1.40|0.36
71809185|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.1|STANDARD_DEVIATION|0.41||0.07|TWO_SIDED|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals|||0.69|-0.89|0.07
71843563|NCT04121741|143200652|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.462|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for RHI (singing coach intervention compared to control) is shown. Estimates of RHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.462
71843564|NCT04121741|143200653|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing video intervention compared to control) is shown. Estimates of fRHI for singing coach intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.005
71843565|NCT04121741|143200653|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.18||0.57|TWO_SIDED|||||Using Bonferroni correction for 3 primary outcomes (FMD, RHI, fRHI), a priori threshold for statistical significance was p\<0.0167.|Regression, Linear|Included outlier detection and removal with estimation of standard models for a three-treatment, cross-over design.|Estimated mean difference for fRHI (singing coach intervention compared to control) is shown. Estimates of fRHI for singing video intervention compared to control also performed.||"Please reference the following pre-print manuscript for additional statistical analyses.~Bagherimohamadipour M, Hammad M, Visotcky A, Sparapani R, Kulinski J. Effects of Singing on Vascular Health in Older Adults with Coronary Artery Disease: A Randomized Trial. medRxiv \[Preprint\]. 2024 Jul 27:2024.07.25.24311033. doi: 10.1101/2024.07.25.24311033. PMID: 39108506; PMCID: PMC11302710."|||0.570
71677356|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.647|||||TWO_SIDED|95.0|0.489|0.856||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.856|0.489|
71843566|NCT01084863|143200663|EQUIVALENCE|Pharmacokinetic equivalence was predefined based on acceptance criteria, 80% to 125%.|Geometric Mean Ratio|104.57|||||TWO_SIDED|90.0|93.64|116.78||||||||116.78|93.64|
71843567|NCT03473223|143200669|SUPERIORITY||Hazard Ratio (HR)|0.925||||0.121|TWO_SIDED|95.0|0.8126|1.0538||1-sided p-value.|Cox proportional hazards regression|||||1.0538|0.8126|0.121
71809186|NCT02130193|143120039|SUPERIORITY_OR_OTHER||Posterior mean difference|-0.3|STANDARD_DEVIATION|0.42||0.17|TWO_SIDED|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals|||0.54|-1.12|0.17
71809187|NCT01297959|143120044|SUPERIORITY|||||||0.39|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.39
71809188|NCT01297959|143120045|SUPERIORITY|||||||0.34|||||||Regression, Logistic|p-value was based on a logistic regression (Chi-square test) model with treatment group as a factor, adjusting for the stratification factors.||||||0.34
71809189|NCT00707031|143120097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was \<=0.4%.|Least squares (LS) mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|0.033|0.297||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), BMI (\<30, \>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate.||||To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.||0.297|0.033|
71809190|NCT00182754|143120114|SUPERIORITY|||||||0.17|||||||Log Rank|||||||0.17
71809191|NCT02085252|143120125|SUPERIORITY_OR_OTHER|||||||0.0318||||||A 2-sided significance level of 5% was used. There was no adjustment for multiple comparisons.|Chi-squared|||The null hypothesis was that there was no difference between the two treatment strategies.||||0.0318
71809192|NCT01420848|143120163|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||It was used the Post Hoc and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.||||0.006
71809193|NCT01420848|143120163|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||The statistical significance was p\<0.05.|ANOVA|||"It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days)."||||0.023
71809194|NCT01420848|143120164|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||After ANOVA it was performed Post Hoc Test and the statistical significance was p\<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)||||0.012
71895270|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|3.45|STANDARD_ERROR_OF_MEAN|1.61||0.0321|TWO_SIDED|95.0|0.3|6.61|||ANCOVA|||Baseline Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||6.61|0.30|0.0321
71809195|NCT01420848|143120164|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||After ANOVA, the Post Hoc Test was done and the statistical significance was p\<0.05.|ANOVA|||"It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days).~Hypothesis: there is at least one difference among the groups (State Anxiety)."||||0.005
71895271|NCT00537940|143312774|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|1.28||0.7889|TWO_SIDED|95.0|-2.17|2.85|||ANCOVA|||Week 21 Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.||2.85|-2.17|0.7889
71809196|NCT01112579|143120165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3|TWO_SIDED|95.0|-2.0|14.9|||ANCOVA|||||14.9|-2.0|0.3
71809197|NCT01112579|143120166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.1||||0.79|TWO_SIDED|95.0|-845.8|633.6|||ANCOVA|||||633.6|-845.8|0.79
71809198|NCT01112579|143120167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.93|TWO_SIDED|95.0|-1.6|3.2|||ANCOVA|||||3.2|-1.6|0.93
71843568|NCT03473223|143200670|SUPERIORITY||Rate ratio|0.971||||0.341|TWO_SIDED|95.0|0.8442|1.1171||1-sided p-value|Negative binomial regression model|||||1.1171|0.8442|0.341
71843569|NCT03473223|143200671|SUPERIORITY||Hazard Ratio (HR)|0.907||||0.038|TWO_SIDED|95.0|0.8132|1.0106||1-sided p-value.|Cox proportional hazards regression|||||1.0106|0.8132|0.038
71843570|NCT03473223|143200672|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.069|TWO_SIDED|95.0|0.8511|1.0224||1-sided p-value.|Cox proportional hazards regression|||||1.0224|0.8511|0.069
71676220|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.98||0.9474|TWO_SIDED|95.0|-1.86|1.99||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.99|-1.86|0.9474
71676221|NCT04075682|142870122|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.9||0.5018|TWO_SIDED|95.0|-2.36|1.16||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.16|-2.36|0.5018
71677357|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.215|||||TWO_SIDED|95.0|0.163|0.284||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.284|0.163|
71809199|NCT00818753|143120168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.08|12.76||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 110mg BID vs Heparin||12.76|0.08|
71809200|NCT00818753|143120168|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||||95.0|0.13|16.82||p-values were not presented as the study was exploratory and not powered to to detect a difference in the treatments|Cochran-Mantel-Haenszel|||Dabigatran 150mg BID vs Heparin||16.82|0.13|
71809201|NCT01986881|143120188|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.97|||<|0.001|TWO_SIDED|95.6|0.848|1.114||Model included treatment as an explanatory factor and cohort category as a stratification factor.|Cox Proportional Hazards Model|||||1.114|0.848|<0.001
71809202|NCT01986881|143120188|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|1.04||||0.002|TWO_SIDED|95.6|0.887|1.211|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.211|0.887|0.002
71809203|NCT01986881|143120188|NON_INFERIORITY|1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.|Hazard Ratio (HR)|0.91|||<|0.001|TWO_SIDED|95.6|0.773|1.065|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.065|0.773|<0.001
71809204|NCT01986881|143120190|SUPERIORITY||Difference in the Least Squares Means|-0.65|||<|0.001|TWO_SIDED|95.0|-0.78|-0.51||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|cLDA Model|||||-0.51|-0.78|<0.001
71809205|NCT01986881|143120190|SUPERIORITY||Difference in the Least Squares Means|-0.58|||<|0.001|TWO_SIDED|95.0|-0.71|-0.44||"Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin+metformin) and Time was a categorical variable."|Constrained longitudinal data analysis|||||-0.44|-0.71|<0.001
71809206|NCT01986881|143120192|SUPERIORITY||Difference in the Least Squares Means|-0.22||||0.247|TWO_SIDED|95.0|-0.6|0.16||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||0.16|-0.60|0.247
71809207|NCT01986881|143120192|SUPERIORITY||Difference in the Least Squares Means|-0.35||||0.063|TWO_SIDED|95.0|-0.72|0.02||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||0.02|-0.72|0.063
71809208|NCT01986881|143120194|SUPERIORITY||Difference in the Least Squares Means|-0.75|||<|0.001|TWO_SIDED|95.0|-0.98|-0.53||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA Model|||||-0.53|-0.98|<0.001
71809209|NCT01986881|143120194|SUPERIORITY||Difference in the Least Squares Means|-0.66|||<|0.001|TWO_SIDED|95.0|-0.89|-0.43||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.|cLDA model|||||-0.43|-0.89|<0.001
71809210|NCT01986881|143120195|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.108|TWO_SIDED|95.8|0.75|1.034|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.034|0.750|0.108
71809211|NCT01986881|143120195|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.15|TWO_SIDED|95.8|0.725|1.057|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.057|0.725|0.150
71809212|NCT01986881|143120195|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.188|TWO_SIDED|95.8|0.735|1.068|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.068|0.735|0.188
71843571|NCT03473223|143200673|SUPERIORITY||Hazard Ratio (HR)|0.827||||0.074|TWO_SIDED|95.0|0.6399|1.0695||1-sided p-value.|Cox proportional hazards regression|||||1.0695|0.6399|0.074
71809213|NCT01986881|143120196|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.385|TWO_SIDED|95.8|0.767|1.113|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.113|0.767|0.385
71809214|NCT01986881|143120196|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.417|TWO_SIDED|95.8|0.739|1.139|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.139|0.739|0.417
71809215|NCT01986881|143120196|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.494|TWO_SIDED|95.8|0.75|1.154|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.154|0.750|0.494
71809216|NCT01986881|143120197|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.081|TWO_SIDED|95.8|0.63|1.036|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.036|0.630|0.081
71809217|NCT01986881|143120197|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.258|TWO_SIDED|95.8|0.638|1.137|||Cox Proportional Hazard Model|"Model included treatment as an explanatory factor and cohort category as a stratification factor.~Renal"||||1.137|0.638|0.258
71809218|NCT01986881|143120197|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.065|TWO_SIDED|95.8|0.568|1.028|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.028|0.568|0.065
71809219|NCT01986881|143120198|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.183|TWO_SIDED|95.0|0.823|1.038||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.038|0.823|0.183
71809220|NCT01986881|143120198|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.45|TWO_SIDED|95.0|0.831|1.086|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.086|0.831|0.450
71809221|NCT01986881|143120198|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.123|TWO_SIDED|95.0|0.785|1.029|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.029|0.785|0.123
71809222|NCT01986881|143120199|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.676|TWO_SIDED|95.0|0.861|1.259|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.259|0.861|0.676
71809223|NCT01986881|143120199|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.139|TWO_SIDED|95.0|0.949|1.451|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.451|0.949|0.139
71809224|NCT01986881|143120199|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.416|TWO_SIDED|95.0|0.727|1.141|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.141|0.727|0.416
71809225|NCT01986881|143120200|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.663|TWO_SIDED|95.0|0.82|1.365||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|||1.365|0.820|0.663
71809226|NCT01986881|143120200|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.415|TWO_SIDED|95.0|0.845|1.505||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.505|0.845|0.415
71809227|NCT01986881|143120200|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.953|TWO_SIDED|95.0|0.736|1.334||A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.||1.334|0.736|0.953
71809228|NCT01986881|143120201|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.006|TWO_SIDED|95.0|0.539|0.902||Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||0.902|0.539|0.006
71809229|NCT01986881|143120201|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.016|TWO_SIDED|95.0|0.502|0.932|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.932|0.502|0.016
71809230|NCT01986881|143120201|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.028|TWO_SIDED|95.0|0.524|0.964|||Cox Proportional Hazards Model|Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.||||0.964|0.524|0.028
71809231|NCT01986881|143120202|SUPERIORITY|Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|0.93||||0.34|TWO_SIDED|95.0|0.797|1.081||Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.|Cox proportional hazards model|||||1.081|0.797|0.340
71809232|NCT01986881|143120202|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.463|TWO_SIDED|95.0|0.784|1.117|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.117|0.784|0.463
71809233|NCT01986881|143120202|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.363|TWO_SIDED|95.0|0.771|1.1|||Cox Proportional Hazards Model|Model included treatment as an explanatory factor and cohort category as a stratification factor.||||1.100|0.771|0.363
71843572|NCT03473223|143200674|SUPERIORITY||Hazard Ratio (HR)|0.909||||0.113|TWO_SIDED|95.0|0.7801|1.0603||1-sided p-value.|Cox proportional hazards regression|||||1.0603|0.7801|0.113
71843573|NCT03473223|143200675|SUPERIORITY||Hazard Ratio (HR)|1.153||||0.767|TWO_SIDED|95.0|0.7867|1.6886||1-sided p-value.|Cox proportional hazards regression|||||1.6886|0.7867|0.767
71676222|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.39||0.25|TWO_SIDED|95.0|-0.31|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.31|0.25
71676223|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|0.56||0.34|TWO_SIDED|95.0|-1.63|0.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.57|-1.63|0.34
71809234|NCT01986881|143120203|SUPERIORITY|Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.|Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.898|1.131||||||||1.131|0.898|
71809235|NCT01986881|143120203|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.937|1.219||||||||1.219|0.937|
71809236|NCT01986881|143120203|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.828|1.085||||||||1.085|0.828|
71843574|NCT03524092|143200694|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|15.2|31.2|||Cochran-Mantel-Haenszel|||||31.2|15.2|<0.001
71843575|NCT03524092|143200695|SUPERIORITY||Risk Difference (RD)|28.5|||<|0.001|TWO_SIDED|95.0|20.2|36.8|||Cochran-Mantel-Haenszel|||||36.8|20.2|<0.001
71843576|NCT03524092|143200696|SUPERIORITY||Risk Difference (RD)|22.5|||<|0.001|TWO_SIDED|95.0|14.5|30.5|||Cochran-Mantel-Haenszel|||||30.5|14.5|<0.001
71809237|NCT01986881|143120204|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.716|0.945||||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.||0.945|0.716|
71843577|NCT03524092|143200697|SUPERIORITY||Risk Difference (RD)|30.2|||<|0.001|TWO_SIDED|95.0|21.9|38.6|||Cochran-Mantel-Haenszel|||||38.6|21.9|<0.001
71843578|NCT03524092|143200698|SUPERIORITY||Risk Difference (RD)|31.0|||<|0.001|TWO_SIDED|95.0|22.4|39.6|||Cochran-Mantel-Haenszel|||||39.6|22.4|<0.001
71843579|NCT03524092|143200699|SUPERIORITY||Risk Difference (RD)|30.6|||<|0.001|TWO_SIDED|95.0|22.3|38.9|||Cochran-Mantel-Haenszel|||||38.9|22.3|<0.001
71843580|NCT03524092|143200700|SUPERIORITY||LS Mean difference (Final Values)|25.24|STANDARD_ERROR_OF_MEAN|3.094|<|0.001|TWO_SIDED|95.0|19.16|31.32|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||31.32|19.16|<0.001
71843581|NCT03524092|143200701|SUPERIORITY||LS Mean difference (Final Values)|-839.64|STANDARD_ERROR_OF_MEAN|245.99|<|0.001|TWO_SIDED|95.0|-1323.08|-356.21|||ANCOVA|ANCOVA with modified baseline observation carried forward (mBOCF).||||-356.21|-1323.08|<0.001
71809238|NCT01986881|143120204|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.673|0.935|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||0.935|0.673|
71809239|NCT01986881|143120204|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.725|1.001|||||Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.|||1.001|0.725|
71809240|NCT01986881|143120205|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.46|||cLDA Model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.46|-0.55|<0.001
71843582|NCT03524092|143200702|SUPERIORITY||LS Mean difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.228|<|0.001|TWO_SIDED|95.0|-1.51|-0.61|||Mixed Models Analysis|||||-0.61|-1.51|<0.001
71843583|NCT03275285|143200710|SUPERIORITY|For PFS, the nominal significance levels at primary analysis was determined using alpha-spending function in order to control overall 1-sided type 1 error at 2.5%. The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis (103 PFS events) was 0.005. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.531||||0.0007|TWO_SIDED|99.0|0.318|0.889||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.005.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arms based on primary analysis.||0.889|0.318|0.0007
71843584|NCT03275285|143200711|SUPERIORITY|The 1-sided nominal significance level to declare overwhelming efficacy at primary analysis was 0.004. Because the median PFS was not reached at the primary analysis, it was described at the final analysis.|Hazard Ratio (HR)|0.548||||0.0016|TWO_SIDED|99.2|0.317|0.948||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.004.|Stratified Log-Rank test|Stratified on number of prior lines of therapy (1 vs \>1) \& revised international staging system stage (I/II vs III vs not classified) as per IRT.|Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|Statistical analysis for comparison of PFS between the Kd and IKd arm based on primary analysis.||0.948|0.317|0.0016
71843585|NCT03275285|143200712|SUPERIORITY||Hazard Ratio (HR)|0.576|||||TWO_SIDED|95.4|0.418|0.792|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.792|0.418|
71843586|NCT03275285|143200713|SUPERIORITY||Hazard Ratio (HR)|0.594|||||TWO_SIDED|95.4|0.424|0.832|||||Hazard Ratio was stratified on number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.832|0.424|
71843587|NCT03275285|143200714|SUPERIORITY|A closed test procedure was used to control the Type I error rate from the primary efficacy endpoints sequentially through the secondary efficacy endpoints. No further testing would be performed unless the significance level had been reached on PFS and testing on subsequent endpoints were continued only if the null hypothesis for the previously tested endpoint was rejected.||||||0.193||||||One-sided p-value based on Stratified Cochran-Mantel-Haenszel test. Threshold for statistical significance level at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on randomization factors according to IRT.||Statistical analysis for comparison of Overall Response between the Kd and IKd arms based on primary analysis.||||0.1930
71843588|NCT03275285|143200721|SUPERIORITY||Stratified Hazard Ratio|0.425|||||TWO_SIDED|95.0|0.269|0.672|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.672|0.269|
71843589|NCT03275285|143200722|SUPERIORITY||Stratified Hazard Ratio|0.495|||||TWO_SIDED|95.0|0.324|0.757|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||0.757|0.324|
71843590|NCT03275285|143200723|SUPERIORITY||Stratified Hazard Ratio|1.143|||||TWO_SIDED|95.0|0.888|1.471|||||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|1.471|0.888|
71843591|NCT03275285|143200724|SUPERIORITY||Stratified Hazard Ratio|0.955|||||TWO_SIDED|95.0|0.74|1.233|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|||1.233|0.740|
71843592|NCT03275285|143200725|SUPERIORITY|\[Not specified\]|[Stratified Hazard Ratio]|0.683|||||TWO_SIDED|95.0|0.496|0.941|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.941|0.496|
71843593|NCT03275285|143200726|SUPERIORITY|\[Not specified\]|Stratified Hazard Ratio|0.663|||||TWO_SIDED|95.0|0.491|0.895|||||Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.|\[Not specified\]||0.895|0.491|
71843594|NCT04039113|143200778|SUPERIORITY||Rate Ratio|0.83||||0.1042|TWO_SIDED|90.0|0.64|1.06||1-sided p-value|Negative Binomial|||||1.06|0.64|0.1042
71809241|NCT01986881|143120205|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.53|-0.44|||cLDA model|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.44|-0.53|<0.001
71843595|NCT04039113|143200778|SUPERIORITY||Rate Ratio|0.83||||0.2085|TWO_SIDED|95.0|0.61|1.11||2-sided p-value|Negative Binomial|||||1.11|0.61|0.2085
71843596|NCT00353496|143200790|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||<|0.001|TWO_SIDED|95.0|0.3|0.73||No p-value adjustment for multiple comparisons.|Log Rank|The log rank test was stratified according to progression status at baseline and prior therapy.||||0.73|0.30|<0.001
71843597|NCT03885232|143200841|SUPERIORITY|We applied a mixed zero-inflated beta regression model that included a fixed binary factor for treatment arm, a random effect for clinic to account for correlation within clinics, and unbalanced parent demographics across study arms.|Incidence Rate Ratio (IRR)|1.04||||0.9|TWO_SIDED|95.0|0.68|1.6|||Generalized linear mixed effects regress|Generalized linear mixed effects regression models||||1.60|0.68|0.9
71843598|NCT03885232|143200842|SUPERIORITY||Other|1.0|||<|0.05|TWO_SIDED||||||Chi-squared|||Calculated individual survey means for vaccine hesitant parents who participated in the survey. Survey consisted of 15 questions with a 7-point Likert scale. We then created a dichotomous variable where 1 = mean \> or equal to 6; 0 = mean \< 6.||||<0.05
71843599|NCT03885232|143200843|SUPERIORITY||Odds Ratio (OR)|1.92|||<|0.05|TWO_SIDED|95.0|0.66|5.64|||Generalized linear mixed effects regress|Adjusted for: study arm, study period (pre vs. post), years in practice, provider type, interaction between study arm and study period||"1. Ho: No difference in the proportion of clinicians using presumptive and Motivational Interviewing techniques between intervention and control.~2. Ho: No difference in the proportion of clinicians time spent talking to vaccine hesitant parents between intervention and control."||5.64|0.66|<0.05
71843600|NCT03260569|143200846|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71843601|NCT03280030|143200871|OTHER|Success criteria is considered based on point estimated Hazard ratio|Hazard Ratio, log|1.326|||||TWO_SIDED|95.0|0.624|2.818||||||||2.818|0.624|
71843602|NCT03211247|143200916|OTHER||Proportion difference|33.4|||<|0.001|TWO_SIDED|95.0|22.36|44.49|||Wald test||The 2-sided Farrington-Manning 95% confidence interval for the difference in response rates was calculated.|Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Farrington-Manning 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Farrignton-Manning 95% CI of the difference in response rates ≥15%.||44.49|22.36|<0.001
71843603|NCT03867201|143200959|SUPERIORITY||Mean Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.64||0.015|TWO_SIDED|95.0|-2.83|-0.3|||Mixed Models Analysis|||||-0.30|-2.83|0.015
71843604|NCT01983683|143200965|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.7|||||TWO_SIDED|95.0|-10.7|1.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|||1.3|-10.7|
71809242|NCT01986881|143120206|SUPERIORITY||Difference in the Least Squares Means|-0.48|||<|0.001|TWO_SIDED|95.0|-0.54|-0.43|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.43|-0.54|<0.001
71895272|NCT00537940|143312775|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.653||||0.0252|TWO_SIDED|95.0|0.449|0.948|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||0.948|0.449|0.0252
71809243|NCT01986881|143120206|SUPERIORITY||Difference in the Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.55|-0.45|||Constrained Longitudinal Data Analysis|Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.45|-0.55|<0.001
71843605|NCT01983683|143200965|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-3.6|||||TWO_SIDED|95.0|-9.6|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT||2.3|-9.6|
71843606|NCT01983683|143200966|NON_INFERIORITY|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%|Difference between 2 proportions|-4.9|||||TWO_SIDED|95.0|-10.4|0.6|||||CI for the difference between two proportions are estimated using the Wilson' score method|||0.6|-10.4|
71843607|NCT01983683|143200967|SUPERIORITY|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|1.7|||||TWO_SIDED|95.0|-6.1|9.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|||9.4|-6.1|
71843608|NCT01983683|143200968|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7794|TWO_SIDED|95.0|0.86|1.24||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank|||||1.24|0.86|0.7794
71809244|NCT01986881|143120207|SUPERIORITY||Difference in the least squares means|-0.37|||<|0.001|TWO_SIDED|95.0|-0.45|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||Ertugliflozin vs. Placebo|||-0.30|-0.45|<0.001
71809245|NCT01986881|143120207|SUPERIORITY||Difference in Least Squares Means|-0.39|||<|0.001|TWO_SIDED|95.0|-0.46|-0.32||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|Ertugliflozin vs. Placebo.||||-0.32|-0.46|<0.001
71809246|NCT01986881|143120209|SUPERIORITY||Difference in the least squares means|-0.31||||0.001|TWO_SIDED|95.0|-0.41|-0.21||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA|||||-0.21|-0.41|0.001
71809247|NCT01986881|143120209|SUPERIORITY||Difference in the least squares means|-0.36|||<|0.001|TWO_SIDED|95.0|-0.46|-0.26||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA model|||||-0.26|-0.46|<0.001
71809248|NCT01986881|143120224|SUPERIORITY||Difference in the Least Squares Means|-17.56|||<|0.001|TWO_SIDED|95.0|-19.49|-15.63|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-15.63|-19.49|<0.001
71843609|NCT01983683|143200969|SUPERIORITY||Least Square Mean difference|-0.044||||0.6871|TWO_SIDED|95.0|-0.26|0.17||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores||0.17|-0.26|0.6871
71843610|NCT01983683|143200969|SUPERIORITY||Least Square Mean difference|0.025||||0.7833|TWO_SIDED|95.0|-0.15|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores||0.20|-0.15|0.7833
71809249|NCT01986881|143120224|SUPERIORITY||Difference in the Least Squares Means|-15.1|||<|0.001|TWO_SIDED|95.0|-17.03|-13.17|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-13.17|-17.03|<0.001
71843611|NCT01983683|143200969|SUPERIORITY||Least Square Mean difference|0.061||||0.4145|TWO_SIDED|95.0|-0.09|0.21||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the other symptoms domain scores||0.21|-0.09|0.4145
71843612|NCT01983683|143200970|OTHER||Difference between 2 proportions|-1.1|||||TWO_SIDED|95.0|-6.5|4.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||4.2|-6.5|
71843613|NCT01983683|143200971|OTHER||Difference between 2 proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||3.3|-6.5|
71843614|NCT01983683|143200972|OTHER||Difference between 2 proportions|8.8|||||TWO_SIDED|95.0|1.1|16.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis||16.4|1.1|
71843615|NCT01983683|143200973|SUPERIORITY|Sensitivity analysis|Difference between 2 proportions|2.7|||||TWO_SIDED|95.0|-5.5|10.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|||10.9|-5.5|
71843616|NCT03400150|143200977|OTHER|||||||0.025|TWO_SIDED|95.0|||||Farrington-Manning|||||||0.025
71843617|NCT05501600|143200978|SUPERIORITY|||||||0.004|||||||Regression, Linear|||||||0.004
71843618|NCT05501600|143200979|SUPERIORITY|||||||0.081616|||||||t-test, 2 sided|||||||0.081616
71843619|NCT02278185|143201009|SUPERIORITY|||||||0.46|||||||Chi-squared|||The difference between metabolic syndrome and treatment were evaluated with the Chi-square test|This study did not meet it's target accrual goal and thus is underpowered to detect a statistically significant difference between the two groups.|||0.46
71809250|NCT01986881|143120231|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
71843620|NCT02278185|143201009|SUPERIORITY|||||||0.46|||||||Chi-squared|||Cohort characteristics for Metabolic Syndrome were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|Cohort characteristics for Metabolic Syndrome, the SPPB, the SHIM/FACT-P, and PSA were summarized by event and arm using counts and percentages for categorical variables and the mean, standard deviation, median, and quartiles for continuous variables. The difference between metabolic syndrome and treatment were evaluated with the Chi-square test. The Wilcoxon signed-rank test was utilized to examine the difference between Month 1 and Month 12 SPPB scores. The Wilcoxon rank-sum test was used to assess the difference of SHIM/FACT-P scores and PSA between arms. These tests were chosen to account for the non-normal distributions of the continuous variables. The difference between PSA progression between arms was examined using the Fisher Exact Test. A heat map of scores ordered by the highest average score was also created. P-values are reported based on a null hypothesis of no difference against a two-sided alternative. Analyses were performed using SAS 9.4 (SAS Inst|||0.46
71843621|NCT02278185|143201020|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||The results are presented in the following format: N Mean (Std Dev) Median (Q1, Q3). In all cases (Overall, Arm 1, and Arm 2) we fail to reject the null hypothesis that the samples come from the same population of scores at Month 1 versus Month 12 at the 0.05 significance level.||||0.5
71843622|NCT00220805|143201036|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|95.0|||||ANOVA|||The primary efficacy comparison for the change in LogMAR from baseline to endpoint was a two-way analysis of variance (ANOVA) with treatment group and center as fixed factors (main effect model).||||0.49
71843623|NCT00220805|143201037|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|||||Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|Cochran-Mantel-Haenszel|||||||0.76
71843624|NCT00220805|143201038|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)||||||0.13
71843625|NCT00220805|143201039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9|TWO_SIDED|95.0|-0.21|0.19|||ANOVA|||||0.19|-0.21|0.90
71843626|NCT00220805|143201041|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Cochran-Mantel-Haenszel|Adjusted to centers||||||0.74
71843627|NCT01288443|143201043|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 100 mg Q2W versus placebo~4. Alirocumab 200 mg Q4W versus placebo~5. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level"||||<0.0001
71843628|NCT01288443|143201043|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
71843629|NCT01288443|143201043|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
71843630|NCT01288443|143201043|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
71843631|NCT01288443|143201043|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤ 0.05.|ANCOVA|||||||<0.0001
71843632|NCT04327843|143201055|OTHER|This is a prospective study with a repeated measures design.||||||0.001||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed||||||0.001
71843633|NCT04327843|143201056|OTHER|This is a prospective study with a repeated measures design.||||||0.43||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.43
71843634|NCT04327843|143201057|OTHER|This is a prospective study with a repeated measures design.||||||0.07||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.07
71843635|NCT04327843|143201058|OTHER|This is a prospective study with a repeated measures design.||||||0.1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.10
71843636|NCT04327843|143201059|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
71843637|NCT04327843|143201060|OTHER|This is a prospective study with a repeated measures design.||||||1||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||1.00
71843638|NCT04327843|143201062|OTHER|This is a prospective study with a repeated measures design.||||||0.75||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.75
71843639|NCT04327843|143201063|OTHER|This is a prospective study with a repeated measures design.||||||0.14||||||The threshold for statistical significance was p\<0.05.|t-test, 2 sided|It was dependent sample pairwise t-tests, two tailed.||||||0.14
71843640|NCT00754065|143201072|SUPERIORITY_OR_OTHER_LEGACY||F-statistic|9.3218||||0.0024||||||Comparison of EV/DNG vs. EE/NGM|ANOVA|||2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors||||0.0024
71843641|NCT01074294|143201189|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.5845|TWO_SIDED|95.0|-1.8|3.19||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between Least Squares (LS) means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||3.19|-1.80|0.5845
71843642|NCT01074294|143201190|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8832|TWO_SIDED|95.0|-1.37|1.18||The p-value was derived using ANCOVA model with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.18|-1.37|0.8832
71895273|NCT00537940|143312775|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.811||||0.3459|TWO_SIDED|95.0|0.524|1.254|||Regression, Logistic|||Week 21: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.||1.254|0.524|0.3459
71676224|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.56||0.76|TWO_SIDED|95.0|-1.26|0.92||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||0.92|-1.26|0.76
71676225|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.15|TWO_SIDED|95.0|-0.42|2.63||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||2.63|-0.42|0.15
71676226|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.66|1.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.66|-1.66|1.00
71676227|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|0.78||0.01|TWO_SIDED|95.0|0.38|3.43||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.43|0.38|0.01
71676228|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.11||0.58|TWO_SIDED|95.0|-1.56|2.8||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.80|-1.56|0.58
71676229|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|1.23||0.39|TWO_SIDED|95.0|-3.47|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.47|0.39
71809251|NCT01986881|143120231|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
71809252|NCT01986881|143120232|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
71809253|NCT01986881|143120232|SUPERIORITY||||||<|0.001|||||||Log Rank|Log-Rank Test for the comparison to Placebo was based on all data (including for those participants who never had the event).||||||<0.001
71809254|NCT01986881|143120240|SUPERIORITY||Difference in the Least Squares Means|-2.78|||<|0.001|TWO_SIDED|95.0|-3.45|-2.1|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-3.45|<0.001
71809255|NCT01986881|143120240|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-3.21|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.21|<0.001
71676230|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.12||0.45|TWO_SIDED|95.0|-3.05|1.35||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.35|-3.05|0.45
71676231|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.34||0.1147|TWO_SIDED|95.0|-0.13|1.21||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.21|-0.13|0.1147
71676232|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.49||0.3721|TWO_SIDED|95.0|-1.41|0.53||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||0.53|-1.41|0.3721
71676233|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.49||0.8827|TWO_SIDED|95.0|-0.89|1.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.03|-0.89|0.8827
71843643|NCT01074294|143201191|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.3864|TWO_SIDED|95.0|-0.72|1.86||The p-value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.86|-0.72|0.3864
71809256|NCT01986881|143120241|SUPERIORITY||Difference in the Least Squares Mean|-3.15|||<|0.001|TWO_SIDED|95.0|-3.85|-2.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.45|-3.85|<0.001
71809257|NCT01986881|143120241|SUPERIORITY||Difference in the Least Squares Means|-2.58|||<|0.001|TWO_SIDED|95.0|-3.28|-1.89|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.89|-3.28|<0.001
71809258|NCT01986881|143120242|SUPERIORITY||Difference in the Least Squares Means|-2.72|||<|0.001|TWO_SIDED|95.0|-3.57|-1.86|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-3.57|<0.001
71809259|NCT01986881|143120242|SUPERIORITY||Difference in the Least Squares Means|-2.7|||<|0.001|TWO_SIDED|95.0|-3.56|-1.85|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.85|-3.56|<0.001
71843644|NCT01074294|143201192|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.0061|TWO_SIDED|95.0|0.1|0.58||The p value was derived using MMRM method with treatment, trial center, visit week, and treatment by visit week interaction as class effects and Week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.58|0.10|0.0061
71809260|NCT01986881|143120244|SUPERIORITY||Difference in the Least Squares Means|-2.6|||<|0.001|TWO_SIDED|95.0|-3.68|-1.52|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.52|-3.68|<0.001
71809261|NCT01986881|143120244|SUPERIORITY||Difference in the Least Squares Means|-2.79|||<|0.001|TWO_SIDED|95.0|-3.87|-1.71|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.71|-3.87|<0.001
71809262|NCT01986881|143120247|SUPERIORITY||Difference in the Least Squares Means|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.56|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.56|-1.37|<0.001
71809263|NCT01986881|143120247|SUPERIORITY||Difference in the Least Means Squares|-0.87|||<|0.001|TWO_SIDED|95.0|-1.28|-0.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.47|-1.28|<0.001
71843645|NCT01074294|143201193|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6932|TWO_SIDED|95.0|-1.64|2.46||The p-value was derived from ANCOVA model, with treatment and trial center as main effects and Week 5 value as covariate.|ANCOVA||This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.46|-1.64|0.6932
71677358|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.145||||||95.0|0.109|0.191||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.191|0.109|
71809264|NCT01986881|143120248|SUPERIORITY||Difference in the Least Squares Means|-0.81|||<|0.001|TWO_SIDED|95.0|-1.22|-0.39|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.39|-1.22|<0.001
71809265|NCT01986881|143120248|SUPERIORITY||Difference in the Least Squares Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.24|-0.41|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.41|-1.24|<0.001
71809266|NCT01986881|143120249|SUPERIORITY||Difference in the Least Squares Means|-0.67||||0.01|TWO_SIDED|95.0|-1.19|-0.16|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.16|-1.19|0.010
71809267|NCT01986881|143120249|SUPERIORITY||Difference in the Least Squares Means|-0.71||||0.006|TWO_SIDED|95.0|-1.22|-0.2|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-0.20|-1.22|0.006
71809268|NCT01986881|143120251|SUPERIORITY||Difference in the least squares means|-0.78||||0.024|TWO_SIDED|95.0|-1.46|-0.1||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.10|-1.46|0.024
71809269|NCT01986881|143120251|SUPERIORITY||Difference in the least squares means|-0.81||||0.02|TWO_SIDED|95.0|-1.48|-0.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis|||||-0.13|-1.48|0.020
71809270|NCT01986881|143120254|SUPERIORITY||Difference in the Least Squares Means|-1.92|||<|0.001|TWO_SIDED|95.0|-2.07|-1.77|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.77|-2.07|<0.001
71809271|NCT01986881|143120254|SUPERIORITY||Difference in the Least Squares Means|-1.63|||<|0.001|TWO_SIDED|95.0|-1.78|-1.47|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.47|-1.78|<0.001
71809272|NCT01986881|143120255|SUPERIORITY||Difference in the Least Squares Means|-2.45|||<|0.001|TWO_SIDED|95.0|-2.67|-2.24|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.24|-2.67|<0.001
71809273|NCT01986881|143120255|SUPERIORITY||Difference in the Least Squares Means|-2.07|||<|0.001|TWO_SIDED|95.0|-2.28|-1.86|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.86|-2.28|<0.001
71809274|NCT01986881|143120256|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.83|-2.22|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.22|-2.83|<0.001
71809275|NCT01986881|143120256|SUPERIORITY||Difference in the Least Squares Means|-2.11|||<|0.001|TWO_SIDED|95.0|-2.39|-1.83|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.83|-2.39|<0.001
71809276|NCT01986881|143120258|SUPERIORITY||Difference in the Least Squares Means|-2.53|||<|0.001|TWO_SIDED|95.0|-2.97|-2.1|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-2.10|-2.97|<0.001
71809277|NCT01986881|143120258|SUPERIORITY||Difference in the Least Squares Means|-2.1|||<|0.001|TWO_SIDED|95.0|-2.52|-1.68|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||-1.68|-2.52|<0.001
71809278|NCT01986881|143120261|SUPERIORITY||Difference in the Lease Squares Means|-1.78|||||TWO_SIDED|95.0|-2.41|-1.15|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-1.15|-2.41|
71809279|NCT01986881|143120261|SUPERIORITY||Difference in the Least Squares Means|-1.19|||||TWO_SIDED|95.0|-1.82|-0.56|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.56|-1.82|
71809280|NCT01986881|143120262|SUPERIORITY||Difference in the Lease Squares Means|-0.88|||||TWO_SIDED|95.0|-1.58|-0.18|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|-0.18|-1.58|
71809281|NCT01986881|143120262|SUPERIORITY||Difference in the Least Squares Means|-0.21|||||TWO_SIDED|95.0|-0.91|0.49|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|0.49|-0.91|
71809282|NCT01986881|143120263|SUPERIORITY||Difference in the least squares means|0.25|||||TWO_SIDED|95.0|-0.59|1.08|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.08|-0.59|
71809283|NCT01986881|143120263|SUPERIORITY||Difference in the least squares means|1.12|||||TWO_SIDED|95.0|0.28|1.95|||||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|||1.95|0.28|
71809284|NCT01986881|143120265|SUPERIORITY||Difference in the Lease Squares Means|1.48|||||TWO_SIDED|95.0|0.31|2.66|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.66|0.31|
71809285|NCT01986881|143120265|SUPERIORITY||Difference in the Least Squares Means|1.66|||||TWO_SIDED|95.0|0.49|2.84|||||||Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|2.84|0.49|
71809286|NCT01986881|143120289|SUPERIORITY||Difference in % vs Placebo|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||||Miettinen \& Nurminen method|0.9|-2.8|
71809287|NCT01986881|143120289|SUPERIORITY||Difference in % vs Placebo|0.3|||||TWO_SIDED|95.0|-1.6|2.1|||||||Miettinen \& Nurminen method|2.1|-1.6|
71843646|NCT01074294|143201194|SUPERIORITY||Mean Difference (Final Values)|0.81||||0.2781|TWO_SIDED|95.0|-0.66|2.28||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.28|-0.66|0.2781
71843647|NCT01074294|143201194|SUPERIORITY||Mean Difference (Final Values)|0.67||||0.4673|TWO_SIDED|95.0|-1.15|2.49||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.49|-1.15|0.4673
71843648|NCT01074294|143201194|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.5719|TWO_SIDED|95.0|-1.54|2.79||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.79|-1.54|0.5719
71843649|NCT01074294|143201194|SUPERIORITY||Mean Difference (Final Values)|0.56||||0.6262|TWO_SIDED|95.0|-1.7|2.83||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||2.83|-1.70|0.6262
71843650|NCT01074294|143201194|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2638|TWO_SIDED|95.0|-1.06|3.87||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.87|-1.06|0.2638
71843651|NCT01074294|143201195|SUPERIORITY||Mean Difference (Final Values)|0.42||||0.3804|TWO_SIDED|95.0|-0.52|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.37|-0.52|0.3804
71843652|NCT01074294|143201195|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.6422|TWO_SIDED|95.0|-0.86|1.39||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.39|-0.86|0.6422
71809288|NCT01986881|143120290|SUPERIORITY||Difference in % vs Placebo|1.3|||||TWO_SIDED|95.0|-5.8|8.4|||||||Miettinen \& Nurminen method|8.4|-5.8|
71809289|NCT01986881|143120290|SUPERIORITY||Difference in % vs Placebo|-1.9|||||TWO_SIDED|95.0|-9.2|5.4|||||||Miettinen \& Nurminen method|5.4|-9.2|
71809290|NCT01986881|143120291|SUPERIORITY||Difference in % vs Placebo|1.4|||||TWO_SIDED|95.0|-17.7|20.4|||||||Miettinen and Nurminen method|20.4|-17.7|
71809291|NCT01986881|143120291|SUPERIORITY||Difference in % vs Placebo|-19.9|||||TWO_SIDED|95.0|-37.5|-1.2|||||||Miettinen and Nurminen method|-1.2|-37.5|
71843653|NCT01074294|143201195|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.6707|TWO_SIDED|95.0|-1.0|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.55|-1.00|0.6707
71843654|NCT01074294|143201195|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.6638|TWO_SIDED|95.0|-1.04|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.64|-1.04|0.6638
71843655|NCT01074294|143201195|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.2252|TWO_SIDED|95.0|-0.56|2.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.36|-0.56|0.2252
71843656|NCT01074294|143201195|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.697|TWO_SIDED|95.0|-1.14|1.7||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.70|-1.14|0.6970
71809292|NCT01986881|143120292|SUPERIORITY||Difference in % vs Placebo|7.9|||||TWO_SIDED|95.0|-5.1|20.5|||||||Based on Miettinen and Nurminen method|20.5|-5.1|
71809293|NCT01986881|143120292|SUPERIORITY||Difference in % vs Placebo|1.0|||||TWO_SIDED|95.0|-12.3|14.2|||||||Miettinen and Nurminen method|14.2|-12.3|
71809294|NCT01986881|143120294|SUPERIORITY||Difference in % vs Placebo|0.0|||||TWO_SIDED|95.0|-2.9|3.0|||||||Miettinen \& Nurminen method|3.0|-2.9|
71809295|NCT01986881|143120294|SUPERIORITY||Difference in % vs Placebo|-1.2|||||TWO_SIDED|95.0|-4.0|1.6|||||||Miettinen \& Nurminen method|1.6|-4.0|
71809296|NCT01986881|143120297|SUPERIORITY||Difference in the Least Squares Means|-25.4|||<|0.001|TWO_SIDED|95.0|-32.84|-17.96|||CLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-17.96|-32.84|<0.001
71676234|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.54|STANDARD_ERROR_OF_MEAN|0.68||0.4335|TWO_SIDED|95.0|-0.8|1.87||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.87|-0.80|0.4335
71676235|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.74||0.4063|TWO_SIDED|95.0|-2.07|0.84||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||0.84|-2.07|0.4063
71676236|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.69|STANDARD_ERROR_OF_MEAN|0.68||0.0132|TWO_SIDED|95.0|0.35|3.03||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||3.03|0.35|0.0132
71676237|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|0.98||0.3949|TWO_SIDED|95.0|-1.08|2.75||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||2.75|-1.08|0.3949
71676238|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|1.08||0.7145|TWO_SIDED|95.0|-2.5|1.72||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.72|-2.50|0.7145
71676239|NCT04075682|142870123|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.98||0.6081|TWO_SIDED|95.0||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||||0.6081
71809297|NCT01986881|143120297|SUPERIORITY||Difference in the Least Squares Means|-19.24|||<|0.001|TWO_SIDED|95.0|-26.8|-11.68|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-11.68|-26.80|<0.001
71809298|NCT01986881|143120298|SUPERIORITY||Difference in the Least Squares Means|-1.88|||<|0.001|TWO_SIDED|95.0|-2.37|-1.13|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.37|<0.001
71809299|NCT01986881|143120298|SUPERIORITY||Difference in the Least Squares Means|-1.62|||<|0.001|TWO_SIDED|95.0|-2.12|-1.13|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.||||-1.13|-2.12|<0.001
71895274|NCT00634543|143312779|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if lower confidence limit of 2-sided 95% CI was less than the non-inferiority margin of 1.39.|Mean Difference (Net)|0.39||||0.2143|TWO_SIDED|95.0|-0.23|1.01|||t-test, 2 sided|P-value was calculated for change from baseline in pain intensity score at Day 43.||||1.01|-0.23|0.2143
71809300|NCT01986881|143120299|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.49|||<|0.001|TWO_SIDED|95.0|1.61|3.83|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||3.83|1.61|<0.001
71809301|NCT01986881|143120299|SUPERIORITY||Adjusted Odds Ratio Relative to Placebo|2.6|||<|0.001|TWO_SIDED|95.0|1.64|4.12|||Regression, Logistic|Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.12|1.64|<0.001
71809302|NCT01986881|143120300|SUPERIORITY||Difference in the Least Squares Means|-2.32||||0.025|TWO_SIDED|95.0|-4.35|-0.3|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.30|-4.35|0.025
71677359|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.504|||||TWO_SIDED|95.0|0.381|0.668||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.668|0.381|
71809303|NCT01986881|143120300|SUPERIORITY||Difference in the Least Squares Means|-2.88||||0.006|TWO_SIDED|95.0|-4.94|-0.82|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||-0.82|-4.94|0.006
71809304|NCT01986881|143120301|SUPERIORITY||Difference in the Least Squares Means|-0.38||||0.533|TWO_SIDED|95.0|-1.56|0.81|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.81|-1.56|0.533
71809305|NCT01986881|143120301|SUPERIORITY||Difference in the Least Squares Means|-0.6||||0.326|TWO_SIDED|95.0|-1.81|0.6|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||0.60|-1.81|0.326
71809306|NCT01986881|143120304|SUPERIORITY||Difference in the Least Squares Means|-12.22||||0.105|TWO_SIDED|95.0|-27.03|2.06|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||2.06|-27.03|0.105
71809307|NCT01986881|143120304|SUPERIORITY||Difference in the Least Squares Means|-13.53||||0.068|TWO_SIDED|95.0|-28.06|1.0|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||1.00|-28.06|0.068
71809308|NCT01986881|143120305|SUPERIORITY||Difference in the Least Squares Means|-0.52||||0.418|TWO_SIDED|95.0|-1.79|0.75|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.75|-1.79|0.418
71809309|NCT01986881|143120305|SUPERIORITY||Difference in the Least Squares Means|-1.07||||0.092|TWO_SIDED|95.0|-2.32|0.18|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||0.18|-2.32|0.092
71809310|NCT01986881|143120306|SUPERIORITY||Odds ratio relative to placebo|1.48||||0.46|TWO_SIDED|95.0|0.52|4.17|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.17|0.52|0.460
71809311|NCT01986881|143120306|SUPERIORITY||Odds ratio relative to placebo|1.62||||0.335|TWO_SIDED|95.0|0.61|4.35|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.||4.35|0.61|0.335
71809312|NCT01986881|143120307|SUPERIORITY||Difference in the Least Squares Means|2.73||||0.255|TWO_SIDED|95.0|-2.0|7.45|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.45|-2.00|0.255
71809313|NCT01986881|143120307|SUPERIORITY||Difference in the Least Squares Means|2.81||||0.235|TWO_SIDED|95.0|-1.85|7.48|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||7.48|-1.85|0.235
71809314|NCT01986881|143120308|SUPERIORITY||Difference in the Least Squares Means|1.98||||0.178|TWO_SIDED|95.0|-0.91|4.86|||cLDA model|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.86|-0.91|0.178
71809315|NCT01986881|143120308|SUPERIORITY||Difference in the Least Squares Means|1.73||||0.23|TWO_SIDED|95.0|-1.11|4.58|||cLDA|Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.||||4.58|-1.11|0.230
71843657|NCT01074294|143201196|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.6008|TWO_SIDED|95.0|-0.64|1.11||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.11|-0.64|0.6008
71809316|NCT01986881|143120309|SUPERIORITY||Difference in the Least Squares Means|-31.37|||<|0.001|TWO_SIDED|95.0|-40.68|-22.07|||CLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-22.07|-40.68|<0.001
71809317|NCT01986881|143120309|SUPERIORITY||Difference in the Least Squares Means|-30.47|||<|0.001|TWO_SIDED|95.0|-40.23|-20.72|||cLDA|cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-20.72|-40.23|<0.001
71809318|NCT01986881|143120310|SUPERIORITY||Difference in the Least Squares Means|-1.94|||<|0.001|TWO_SIDED|95.0|-2.65|-1.24|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-1.24|-2.65|<0.001
71809319|NCT01986881|143120310|SUPERIORITY||Difference in the Least Squares Means|-1.57|||<|0.001|TWO_SIDED|95.0|-2.3|-0.84|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.||||-0.84|-2.30|<0.001
71676240|NCT04075682|142870124|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.26|STANDARD_ERROR_OF_MEAN|0.46||0.58|TWO_SIDED|95.0|-1.15|0.64||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.64|-1.15|0.58
71677360|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||TWO_SIDED|95.0|0.57|0.997||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.997|0.570|
71809320|NCT01986881|143120311|SUPERIORITY||Adjusted odds ratio relative to placebo|4.1|||<|0.001|TWO_SIDED|95.0|2.0|8.42|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||8.42|2.00|<0.001
71895275|NCT00634543|143312780|SUPERIORITY_OR_OTHER|||||||0.7539|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 15.||||||0.7539
71895276|NCT00634543|143312780|SUPERIORITY_OR_OTHER|||||||0.5905|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 29.||||||0.5905
71895277|NCT00634543|143312780|SUPERIORITY_OR_OTHER|||||||0.7407|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 43.||||||0.7407
71895278|NCT00634543|143312781|SUPERIORITY_OR_OTHER|||||||0.3504|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.3504
71809321|NCT01986881|143120311|SUPERIORITY||Adjusted odds ratio relative to placebo|5.97|||<|0.001|TWO_SIDED|95.0|2.86|12.49|||Regression, Logistic|Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous).||Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.||12.49|2.86|<0.001
71809322|NCT01986881|143120312|SUPERIORITY||Difference in the Least Squares Means|-0.85||||0.597|TWO_SIDED|95.0|-4.0|2.3|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||2.30|-4.00|0.597
71809323|NCT01986881|143120312|SUPERIORITY||Difference in the Least Squares Means|-1.57||||0.351|TWO_SIDED|95.0|-4.87|1.73|||cLDA|The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.73|-4.87|0.351
71809324|NCT01986881|143120313|SUPERIORITY||Difference in the Least Squares Means|-0.68||||0.49|TWO_SIDED|95.0|-2.6|1.25|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.25|-2.60|0.490
71809325|NCT01986881|143120313|SUPERIORITY||Difference in the Least Squares Means|-0.05||||0.958|TWO_SIDED|95.0|-2.07|1.96|||cLDA|Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.||||1.96|-2.07|0.958
71809326|NCT04179175|143120314|OTHER||Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.59|1.29|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.29|0.59|0.250
71809327|NCT04179175|143120314|OTHER||Hazard Ratio (HR)|0.7||||0.044|TWO_SIDED|95.0|0.47|1.05|||Log Rank|one-sided stratified log-rank test, with region and body weight (\<90 kg, ≥ 90 kg) as strata||||1.05|0.47|0.044
71809328|NCT04149925|143120323|SUPERIORITY|||||||0.01||||||Significant when p\<0.05|t-test, 2 sided|||||||0.01
71809329|NCT03014674|143120336|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.04|||||TWO_SIDED|90.0|0.98|1.11|||||Ratio (autoinjector/lyophilized drug) for Cmax has been presented|||1.11|0.98|
71809330|NCT03014674|143120336|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.06|||||TWO_SIDED|90.0|0.99|1.12|||||Ratio (safety syringe/lyophilized drug) for Cmax has been presented|||1.12|0.99|
71809331|NCT03014674|143120337|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)|Ratio|1.08|||||TWO_SIDED|90.0|1.01|1.15|||||Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented|||1.15|1.01|
71895279|NCT00634543|143312782|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).||||||0.5690
71895280|NCT05299892|143312795|OTHER||Mean Difference (Final Values)|6.46153||||0.005|TWO_SIDED|95.0|1.79|12.99|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.||12.99|1.79|.005
71895281|NCT05299892|143312795|OTHER||Mean Difference (Final Values)|9.00961|||<|0.001|TWO_SIDED|95.0|3.91|15.11|||ANOVA|||An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.||15.11|3.91|<.001
71895282|NCT05299892|143312795|OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.||||<0.001
71843658|NCT01074294|143201196|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.5859|TWO_SIDED|95.0|-0.72|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.27|-0.72|0.5859
71843659|NCT01074294|143201196|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.7406|TWO_SIDED|95.0|-0.96|1.34||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.34|-0.96|0.7406
71843660|NCT01074294|143201196|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8568|TWO_SIDED|95.0|-1.14|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.37|-1.14|0.8568
71843661|NCT01074294|143201196|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6044|TWO_SIDED|95.0|-0.96|1.64||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.64|-0.96|0.6044
71843662|NCT01074294|143201196|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.6772|TWO_SIDED|95.0|-1.08|1.66||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.66|-1.08|0.6772
71843663|NCT01074294|143201197|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.7881|TWO_SIDED|95.0|-0.87|1.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.15|-0.87|0.7881
71843664|NCT01074294|143201197|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.8841|TWO_SIDED|95.0|-1.38|1.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.19|-1.38|0.8841
71843665|NCT01074294|143201197|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.7589|TWO_SIDED|95.0|-1.61|1.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.17|-1.61|0.7589
71843666|NCT01074294|143201197|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.5375|TWO_SIDED|95.0|-1.01|1.93||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.93|-1.01|0.5375
71843667|NCT01074294|143201197|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.4456|TWO_SIDED|95.0|-0.92|2.08||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.08|-0.92|0.4456
71843668|NCT01074294|143201197|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.667|TWO_SIDED|95.0|-1.21|1.89||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.89|-1.21|0.6670
71843669|NCT01074294|143201198|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9708|TWO_SIDED|95.0|-0.97|1.01||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.01|-0.97|0.9708
71843670|NCT01074294|143201198|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.397|TWO_SIDED|95.0|-0.65|1.63||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.63|-0.65|0.3970
71843671|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9568|TWO_SIDED|95.0|0.68|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 7||1.50|0.68|0.9568
71843672|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|0.91||||0.6308|TWO_SIDED|95.0|0.63|1.31||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 9||1.31|0.63|0.6308
71809332|NCT03014674|143120337|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).|Ratio|1.04|||||TWO_SIDED|90.0|0.97|1.12|||||Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented|||1.12|0.97|
71809333|NCT03014674|143120337|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.07|||||TWO_SIDED|90.0|1.0|1.13|||||Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented|||1.13|1.00|
71809334|NCT03014674|143120337|EQUIVALENCE|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.02|||||TWO_SIDED|90.0|0.95|1.09|||||Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented|||1.09|0.95|
71809335|NCT04250727|143120359|SUPERIORITY|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||||||0.601
71809336|NCT00160680|143120405|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|||=|0.667|TWO_SIDED|95.0|-0.96|1.5|||ANCOVA|||||1.50|-0.96|=0.667
71843673|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|0.92||||0.6698|TWO_SIDED|95.0|0.64|1.32||The p-value was derived from CMH general association test controlling for study center|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Falling Asleep: Week 11||1.32|0.64|0.6698
71843674|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|0.76||||0.2012|TWO_SIDED|95.0|0.5|1.15||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 7||1.15|0.50|0.2012
71843675|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|0.78||||0.2365|TWO_SIDED|95.0|0.52|1.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 9||1.16|0.52|0.2365
71809337|NCT00985725|143120424|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0||||0.0009|TWO_SIDED|95.0|-12.7|-3.3|||ANCOVA|||||-3.3|-12.7|0.0009
71809338|NCT00985725|143120425|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0465|TWO_SIDED|95.0|-3.7|0.0|||ANCOVA|||||0.0|-3.7|0.0465
71809339|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0181|TWO_SIDED|95.0|-9.4|-0.9|||ANCOVA|||Behavioral recognition index||-0.9|-9.4|0.0181
71809340|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2||||0.0204|TWO_SIDED|95.0|-7.7|-0.7|||ANCOVA|||Inhibit subscale||-0.7|-7.7|0.0204
71809341|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6||||0.009|TWO_SIDED|95.0|-9.8|-1.4|||ANCOVA|||Shift subscale||-1.4|-9.8|0.0090
71809342|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.0793|TWO_SIDED|95.0|-7.9|0.4|||ANCOVA|||Emotional control subscale||0.4|-7.9|0.0793
71809343|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.1014|TWO_SIDED|95.0|-7.0|0.6|||ANCOVA|||Self-monitor subscale||0.6|-7.0|0.1014
71843676|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|0.65||||0.0312|TWO_SIDED|95.0|0.44|0.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Difficulty Staying Asleep: Week 11||0.96|0.44|0.0312
71809344|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0||||0.0002|TWO_SIDED|95.0|-13.7|-4.3|||ANCOVA|||Metacognition index||-4.3|-13.7|0.0002
71809345|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6||||0.0002|TWO_SIDED|95.0|-12.9|-4.2|||ANCOVA|||Initiate subscale||-4.2|-12.9|0.0002
71809346|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1||||0.0001|TWO_SIDED|95.0|-13.7|-4.5|||ANCOVA|||Working memory subscale||-4.5|-13.7|0.0001
71809347|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.5||||0.001|TWO_SIDED|95.0|-11.9|-3.1|||ANCOVA|||Plan/Organize subscale||-3.1|-11.9|0.0010
71809348|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0357|TWO_SIDED|95.0|-9.4|-0.3|||ANCOVA|||Task monitor subscale||-0.3|-9.4|0.0357
71809349|NCT00985725|143120426|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.0012|TWO_SIDED|95.0|-11.1|-2.8|||ANCOVA|||Organization of materials subscale||-2.8|-11.1|0.0012
71809350|NCT00985725|143120431|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.1731|TWO_SIDED|95.0|-10.9|2.0|||ANCOVA|||||2.0|-10.9|0.1731
71809351|NCT02548455|143120443|EQUIVALENCE|Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).|Kaplan-Meier Estimate|85.0||||0.05|TWO_SIDED||||||Log Rank|||"The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) \> 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects."||||0.05
71843677|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6408|TWO_SIDED|95.0|0.69|1.81||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 7||1.81|0.69|0.6408
71843678|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|1.24||||0.3467|TWO_SIDED|95.0|0.79|1.96||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 9||1.96|0.79|0.3467
71895283|NCT05483127|143312844|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference=P1fA - MDT. Sign (negative or positive) is retained with the rounded value.|||-0.00||
71895284|NCT00315302|143312845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.24||0.21||95.0|-0.2|0.8|||ANCOVA||The difference was calculated as atropine plus plano group minus atropine group|"The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.~The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks."||0.8|-0.2|0.21
71809352|NCT02436330|143120457|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0615||||0.0967|TWO_SIDED|95.0|-0.1344|0.0115||We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.|t-test, 2 sided|||||0.0115|-0.1344|0.0967
71895285|NCT00315302|143312846|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group"||||.03
71895286|NCT00315302|143312847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|3.1|||TWO_SIDED|95.0|3.2|5.8||||||95% confidence interval calculated within treatment group on the amount of change from baseline||5.8|3.2|
71895287|NCT00315302|143312847|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_DEVIATION|3.7|||TWO_SIDED|95.0|3.7|6.4||||||95% confidence interval calculated within treatment group on the amount of change from baseline||6.4|3.7|
71809353|NCT02436330|143120458|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0775||||0.0335|TWO_SIDED|95.0|-0.1485|-0.00652|||t-test, 2 sided|||||-0.00652|-0.1485|0.0335
71809354|NCT02436330|143120459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.991|TWO_SIDED|95.0|-5.2|5.1|||t-test, 2 sided|||||5.1|-5.2|0.991
71895288|NCT00315302|143312848|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group"||||0.39
71895289|NCT00315302|143312849|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||All patients without respect to cause of amblyopia.||||0.39
71809355|NCT02436330|143120460|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.851|TWO_SIDED|95.0|-9.0|11.0|||t-test, 2 sided|||||11|-9|0.851
71809356|NCT02436330|143120461|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.501|TWO_SIDED|95.0|-11.7|5.8|||t-test, 2 sided|||||5.8|-11.7|0.501
71809357|NCT02436330|143120462|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2971||||0.035|TWO_SIDED|95.0|0.0224|0.5718|||t-test, 2 sided|||||0.5718|0.0224|0.035
71809358|NCT02436330|143120463|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9464||||0.2207|TWO_SIDED|95.0|-2.4954|0.6025|||t-test, 2 sided|||||0.6025|-2.4954|0.2207
71809359|NCT02436330|143120464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0491||||0.4164|TWO_SIDED|95.0|-3.6407|1.5425|||t-test, 2 sided|||||1.5425|-3.6407|0.4164
71809360|NCT02436330|143120465|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2433.7||||0.812|TWO_SIDED|95.0|-18579.7|23447.2|||t-test, 2 sided|||||23447.2|-18579.7|0.812
71809361|NCT02436330|143120466|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2837||||0.3326|TWO_SIDED|95.0|-0.3037|0.8711|||t-test, 2 sided|||||0.8711|-0.3037|0.3326
71809362|NCT02436330|143120467|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2995||||0.1856|TWO_SIDED|95.0|-0.2051|0.8041|||t-test, 2 sided|||||0.8041|-0.2051|0.1856
71809363|NCT02436330|143120468|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-247.9||||0.0849|TWO_SIDED|95.0|-531.7|35.8686|||t-test, 2 sided|||||35.8686|-531.7|0.0849
71809364|NCT02436330|143120469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.2048||||0.176|TWO_SIDED|95.0|-10.3835|1.974|||t-test, 2 sided|||||1.9740|-10.3835|0.176
71809365|NCT02436330|143120470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.2151||||0.0247|TWO_SIDED|95.0|0.973|13.457|||t-test, 2 sided|||||13.457|0.973|0.0247
71895290|NCT00315302|143312850|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||Among anisometropic patients only||||0.90
71895291|NCT00315302|143312852|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||"Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;~Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups"||||0.003
71676241|NCT04075682|142870124|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.9||0.82|TWO_SIDED|95.0|-1.98|1.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.57|-1.98|0.82
71677361|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.756|||||TWO_SIDED|95.0|2.083|3.647||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.647|2.083|
71809366|NCT02436330|143120471|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8169||||0.2764|TWO_SIDED|95.0|-2.4147|0.7808|||t-test, 2 sided|||||0.7808|-2.4147|0.2764
71809367|NCT02436330|143120472|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7958||||0.0008|TWO_SIDED|95.0|-1.235|-0.3566|||t-test, 2 sided|||||-0.3566|-1.2350|0.0008
71809368|NCT02436330|143120473|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7024||||0.6974|TWO_SIDED|95.0|-2.9377|4.3425|||t-test, 2 sided|||||4.3425|-2.9377|0.6974
71809369|NCT02436330|143120475|SUPERIORITY_OR_OTHER|||||||0.2122|TWO_SIDED||||||t-test, 2 sided|||||||0.2122
71809370|NCT02436330|143120476|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.61||||0.1265|TWO_SIDED|95.0|-1.15|8.33|||t-test, 2 sided|||||8.33|-1.15|0.1265
71809371|NCT02436330|143120477|SUPERIORITY_OR_OTHER|||||||0.3671|TWO_SIDED||||||t-test, 2 sided|||||||0.3671
71843679|NCT01074294|143201199|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9437|TWO_SIDED|95.0|0.65|1.59||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the Cochran-Mantel-Haenszel (CMH) model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Waking Up Too Early: Week 11||1.59|0.65|0.9437
71809372|NCT02436330|143120478|SUPERIORITY_OR_OTHER|||||||0.4892|TWO_SIDED||||||t-test, 2 sided|||||||0.4892
71809373|NCT05711641|143120494|OTHER|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|Generalized Estimating Equations|||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|VAS was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
71809374|NCT05711641|143120495|OTHER|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|Tinnitus loudness was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
71809375|NCT05711641|143120496|OTHER|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).||||||||||||||||"The alternative hypothesis of this study is that 10% lidocaine, applied topically to the external auditory canal (EAC), acts on tinnitus intensity differently than placebo, while the null hypothesis is that there is no difference between the action of lidocaine and placebo on tinnitus intensity.~The analyses were performed using the IBM-SPSS for Windows software version 22.0 and tabulated using the Microsoft-Excel 2010 software, and the tests were performed with a significance level of 5%."|MML was described with the use of summary measures, and the variations between the applied substances were compared with the use of Generalized Estimating Equations (GEE) with normal marginal distribution and identity binding function, assuming an interchangeable correlation matrix between the substances (McCullagh; Nelder, 1989).|||
71843680|NCT01074294|143201200|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.6357|TWO_SIDED|95.0|-1.3|2.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||2.12|-1.30|0.6357
71895292|NCT00440401|143312856|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0001
71676242|NCT04075682|142870124|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|1.31||0.2|TWO_SIDED|95.0|-0.9|4.24||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||4.24|-0.90|0.20
71677362|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.916|||||TWO_SIDED|95.0|0.694|1.211||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.211|0.694|
71809376|NCT00162370|143120497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Regression, Cox|||The null hypothesis evaluated is that the scores are not associated with outcome. Of the two measures, wall motion index is considered to be the primary endpoint measure. The cardiac event rate will be summarized by categorical levels of wall motion index score and the difference in wall motion index score.||||0.014
71843681|NCT01074294|143201200|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.6536|TWO_SIDED|95.0|-1.56|2.48||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||2.48|-1.56|0.6536
71895293|NCT00440401|143312857|SUPERIORITY_OR_OTHER||||||<|0.0006||95.0|||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals||||||<0.0006
71895294|NCT00258154|143312898|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 10 mIU/mL greater than -10%|Percentage point difference|0.0|||<|0.001||95.0|-3.7|3.6|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||3.6|-3.7|<0.001
71895295|NCT00258154|143312900|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 0.15 μg/mL greater than -10%.|Percentage point difference|-3.7||||0.015||95.0|-9.3|1.3|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq - Placebo)|||1.3|-9.3|0.015
71895296|NCT00847613|143312930|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|36.48|||<|0.0001|TWO_SIDED|95.0|27.73|45.23||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||45.23|27.73|<0.0001
71843682|NCT01074294|143201200|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9475|TWO_SIDED|95.0|-2.2|2.06||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||2.06|-2.20|0.9475
71895297|NCT00847613|143312930|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|26.13|||<|0.0001|TWO_SIDED|95.0|17.28|34.97||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||34.97|17.28|<0.0001
71809377|NCT00162370|143120498|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Regression, Cox|||||||<0.0001
71809378|NCT04575051|143120509|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.58|TWO_SIDED|95.0|-1.1|1.96|||Mixed Models Analysis||Difference in the adjusted means for the Consult model and HearCARE model.|The null hypothesis is that the HearCARE intervention does not improve satisfaction with social participation.||1.96|-1.10|0.58
71809379|NCT04575051|143120510|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.95|TWO_SIDED|95.0|-1.13|1.1|||Mixed Models Analysis||The estimated parameter represents the difference between the adjusted means for the Consult and HearCARE models.|The null hypothesis is that the HearCARE intervention does not improve hearing related quality of life.||1.10|-1.13|0.95
71809380|NCT04575051|143120511|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.96|TWO_SIDED|95.0|-1.2|1.14|||Mixed Models Analysis||Estimated Value represents the difference in the means for the Consult and HearCARE models.|||1.14|-1.20|0.96
71895298|NCT00847613|143312931|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0376|TWO_SIDED|95.0|-0.79|-0.02||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||-0.02|-0.79|0.0376
71843683|NCT01074294|143201200|SUPERIORITY||Mean Difference (Final Values)|0.99||||0.3973|TWO_SIDED|95.0|-1.31|3.29||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||3.29|-1.31|0.3973
71843684|NCT01074294|143201200|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.2336|TWO_SIDED|95.0|-0.96|3.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||3.91|-0.96|0.2336
71809381|NCT04575051|143120512|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.13|TWO_SIDED|95.0|-0.07|0.48|||Mixed Models Analysis||The Estimated Value is the difference between the means of the Consult and HearCARE models.|||0.48|-0.07|0.13
71809382|NCT03624504|143120513|OTHER|Assume expected performance to be 94%. The Objective Performance Criterion (OPC) is set at 83% (same performance threshold in FDA approved global study). Assumes 0.05 significance level, 2-sided, 80% power and 10% study attrition.|Kaplan-Meier survival probability (%)|97.6||||0.0021|TWO_SIDED|95.0|90.6|99.4||The threshold for significance was 0.05.|z test, 1-sided||The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."||99.4|90.6|0.0021
71809383|NCT04496219|143120536|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||This p value relates to instillation adherence||||0.97
71843685|NCT01074294|143201200|SUPERIORITY||Mean Difference (Final Values)|0.95||||0.4553|TWO_SIDED|95.0|-1.55|3.44||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||3.44|-1.55|0.4553
71843686|NCT01074294|143201201|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.5647|TWO_SIDED|95.0|-0.7|1.27||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.27|-0.70|0.5647
71843687|NCT01074294|143201201|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.9739|TWO_SIDED|95.0|-1.15|1.12||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.12|-1.15|0.9739
71895299|NCT00847613|143312931|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0792|TWO_SIDED|95.0|-0.73|0.04||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.||0.04|-0.73|0.0792
71895300|NCT00847613|143312932|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.49|-0.31||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in mTSS had to be significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.31|-0.49|<0.0001
71809384|NCT04496219|143120536|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||This p value relates to missed visits.||||0.17
71809385|NCT04496219|143120537|SUPERIORITY|||||||0.5638|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.||||0.5638
71809386|NCT04496219|143120537|SUPERIORITY|||||||0.1753|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.||||0.1753
71809387|NCT04496219|143120537|SUPERIORITY|||||||0.2062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.||||0.2062
71843688|NCT01074294|143201201|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8077|TWO_SIDED|95.0|-1.4|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.09|-1.40|0.8077
71809388|NCT04496219|143120538|SUPERIORITY|||||||0.8092|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.||||0.8092
71809389|NCT04496219|143120538|SUPERIORITY|||||||0.5492|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.||||0.5492
71809390|NCT04496219|143120538|SUPERIORITY|||||||0.6464|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.||||0.6464
71809391|NCT04496219|143120538|SUPERIORITY|||||||0.586|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.||||0.586
71809392|NCT04496219|143120538|SUPERIORITY|||||||0.8999|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.||||0.8999
71809393|NCT04496219|143120538|SUPERIORITY|||||||0.2007|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.||||0.2007
71676243|NCT04075682|142870124|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.36||0.88|TWO_SIDED|95.0|-0.77|0.66||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation analysis are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.66|-0.77|0.8800
71676244|NCT04075682|142870124|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Median Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8864|TWO_SIDED|95.0|-1.3|1.5||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.50|-1.30|0.8864
71809394|NCT04496219|143120538|SUPERIORITY|||||||0.9921|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.||||0.9921
71809395|NCT04496219|143120538|SUPERIORITY|||||||0.5723|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.||||0.5723
71809396|NCT04496219|143120538|SUPERIORITY|||||||0.812|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.||||0.812
71809397|NCT04496219|143120538|SUPERIORITY|||||||0.96|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.||||0.96
71809398|NCT04496219|143120538|SUPERIORITY|||||||0.1062|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.||||0.1062
71809399|NCT04496219|143120538|SUPERIORITY|||||||0.3259|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.||||0.3259
71809400|NCT04496219|143120538|SUPERIORITY|||||||0.9664|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.||||0.9664
71809401|NCT04496219|143120538|SUPERIORITY|||||||0.4564|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.||||0.4564
71809402|NCT04496219|143120538|SUPERIORITY|||||||0.1036|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.||||0.1036
71809403|NCT04496219|143120538|SUPERIORITY|||||||0.1789|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.||||0.1789
71809404|NCT04496219|143120538|SUPERIORITY|||||||0.5186|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.||||0.5186
71809405|NCT04496219|143120538|SUPERIORITY|||||||0.0757|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.||||0.0757
71809406|NCT04496219|143120538|SUPERIORITY|||||||0.1174|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.||||0.1174
71809407|NCT04496219|143120538|SUPERIORITY|||||||0.3129|||||||Chi-squared|||For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.||||0.3129
71809408|NCT00540124|143120589|SUPERIORITY_OR_OTHER|||||||0.073||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.073
71809409|NCT00540124|143120589|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.186
71809410|NCT00540124|143120590|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
71809411|NCT00540124|143120590|SUPERIORITY_OR_OTHER|||||||0.155||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.155
71809412|NCT00540124|143120590|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.108
71809413|NCT00540124|143120590|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.112
71809414|NCT00540124|143120591|SUPERIORITY_OR_OTHER|||||||0.137||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.137
71676245|NCT04075682|142870124|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|1.12|STANDARD_ERROR_OF_MEAN|1.02||0.2748|TWO_SIDED|95.0|-0.89|3.12||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordered logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||3.12|-0.89|0.2748
71809415|NCT00540124|143120591|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.009
71809416|NCT00540124|143120591|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.118
71809417|NCT00540124|143120591|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.018
71843689|NCT01074294|143201201|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.6119|TWO_SIDED|95.0|-0.98|1.65||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.65|-0.98|0.6119
71843690|NCT01074294|143201201|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.5513|TWO_SIDED|95.0|-0.94|1.76||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.76|-0.94|0.5513
71843691|NCT01074294|143201201|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4185|TWO_SIDED|95.0|-0.81|1.95||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.95|-0.81|0.4185
71843692|NCT01074294|143201202|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.7556|TWO_SIDED|95.0|-0.8|1.09||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.09|-0.80|0.7556
71843693|NCT01074294|143201202|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.371|TWO_SIDED|95.0|-0.6|1.59||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.59|-0.60|0.3710
71843694|NCT01074294|143201202|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.8464|TWO_SIDED|95.0|-0.99|1.21||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.21|-0.99|0.8464
71809418|NCT00540124|143120591|SUPERIORITY_OR_OTHER|||||||0.207||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.207
71809419|NCT00540124|143120591|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.581
71809420|NCT00540124|143120592|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.306
71809421|NCT00540124|143120592|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
71809422|NCT00540124|143120592|SUPERIORITY_OR_OTHER|||||||0.203||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.203
71843695|NCT01074294|143201202|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.2664|TWO_SIDED|95.0|-0.53|1.91||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.91|-0.53|0.2664
71843696|NCT01074294|143201202|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.0876|TWO_SIDED|95.0|-0.17|2.42||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||2.42|-0.17|0.0876
71676246|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.5||0.83|TWO_SIDED|95.0|0.45|2.7||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||2.70|0.45|0.83
71677363|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.616|||||TWO_SIDED|95.0|0.466|1.815||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.815|0.466|
71809423|NCT00540124|143120592|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.464
71809424|NCT00540124|143120592|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.169
71809425|NCT00540124|143120592|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.243
71809426|NCT00540124|143120593|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.206
71843697|NCT01074294|143201202|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.5119|TWO_SIDED|95.0|-0.89|1.77||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.77|-0.89|0.5119
71843698|NCT01074294|143201203|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.8986|TWO_SIDED|95.0|-1.03|1.18||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||1.18|-1.03|0.8986
71843699|NCT01074294|143201203|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.685|TWO_SIDED|95.0|-1.02|1.55||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||1.55|-1.02|0.6850
71843700|NCT01074294|143201203|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.7108|TWO_SIDED|95.0|-1.61|1.1||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||1.10|-1.61|0.7108
71809427|NCT00540124|143120593|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.457
71809428|NCT00540124|143120593|SUPERIORITY_OR_OTHER|||||||0.892||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.892
71809429|NCT00540124|143120593|SUPERIORITY_OR_OTHER|||||||0.593||95.0||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.593
71809430|NCT00540124|143120593|SUPERIORITY_OR_OTHER|||||||0.887||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.887
71809431|NCT00540124|143120593|SUPERIORITY_OR_OTHER|||||||0.762||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time\*treatment interaction. Model used an unstructured covariance.|ANCOVA|||||||0.762
71809432|NCT00540124|143120594|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.691
71843701|NCT01074294|143201203|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.9236|TWO_SIDED|95.0|-1.5|1.36||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||1.36|-1.50|0.9236
71843702|NCT01074294|143201203|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.8576|TWO_SIDED|95.0|-1.35|1.61||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||1.61|-1.35|0.8576
71843703|NCT01074294|143201203|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.8483|TWO_SIDED|95.0|-1.67|1.37||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||1.37|-1.67|0.8483
71843704|NCT01074294|143201204|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6976|TWO_SIDED|95.0|-0.22|0.15||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 6||0.15|-0.22|0.6976
71843705|NCT01074294|143201204|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.6986|TWO_SIDED|95.0|-0.25|0.17||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 7||0.17|-0.25|0.6986
71676247|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.86|STANDARD_ERROR_OF_MEAN|1.34||0.03|TWO_SIDED|95.0|1.14|7.18||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||7.18|1.14|0.03
71843706|NCT01074294|143201204|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6507|TWO_SIDED|95.0|-0.3|0.19||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 8||0.19|-0.30|0.6507
71843707|NCT01074294|143201204|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.655|TWO_SIDED|95.0|-0.32|0.2||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 9||0.20|-0.32|0.6550
71843708|NCT01074294|143201204|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.3959|TWO_SIDED|95.0|-0.15|0.38||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 10||0.38|-0.15|0.3959
71843709|NCT01074294|143201204|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.6763|TWO_SIDED|95.0|-0.23|0.35||The p-value was derived using MMRM method with treatment, study center, visit week, and treatment by visit week interaction as class effects, and week 5 value as covariate.|Mixed Models Analysis||The difference between LS means derived from the MMRM model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Change at Week 11||0.35|-0.23|0.6763
71843710|NCT01074294|143201205|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.4089|TWO_SIDED|95.0|-0.37|0.91||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.91|-0.37|0.4089
71843711|NCT01074294|143201206|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2331|TWO_SIDED|95.0|-0.8|0.2||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||Week 11 data is included here. The planned sample size of 225 participants (150 in brexipiprazole arm and 75 in the placebo arm) yielded at least 80% power to detect effects at a 2-tailed significance level of 0.05 using a two-sided z-test.|||0.20|-0.80|0.2331
71843712|NCT01074294|143201207|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.067|TWO_SIDED|95.0|-0.01|0.0||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.00|-0.01|0.0670
71843713|NCT01074294|143201208|SUPERIORITY||Mean Difference (Final Values)|-14.3||||0.0849|TWO_SIDED|95.0|-30.5|1.98||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||1.98|-30.5|0.0849
71677364|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.149|||||TWO_SIDED|95.0|1.624|2.843||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.843|1.624|
71809433|NCT00540124|143120594|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.415
71809434|NCT00540124|143120595|SUPERIORITY_OR_OTHER|||||||0.176||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.176
71809435|NCT00540124|143120595|SUPERIORITY_OR_OTHER|||||||0.921||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.921
71809436|NCT00540124|143120596|SUPERIORITY_OR_OTHER|||||||0.429||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.429
71809437|NCT00540124|143120596|SUPERIORITY_OR_OTHER|||||||0.304||95.0||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel|||||||0.304
71809438|NCT00540124|143120597|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.254
71809439|NCT00540124|143120597|SUPERIORITY_OR_OTHER|||||||0.359||95.0||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.359
71809440|NCT00540124|143120597|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.098
71809441|NCT00540124|143120597|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.632
71809442|NCT00540124|143120597|SUPERIORITY_OR_OTHER|||||||0.102||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.102
71809443|NCT00540124|143120597|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.348
71809444|NCT00540124|143120598|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.208
71809445|NCT00540124|143120598|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.985
71843714|NCT01074294|143201209|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.7663|TWO_SIDED|95.0|-3.52|2.6||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||2.60|-3.52|0.7663
71809446|NCT00540124|143120599|SUPERIORITY_OR_OTHER|||||||0.385||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.385
71809447|NCT00540124|143120599|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.595
71809448|NCT00540124|143120599|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.704
71809449|NCT00540124|143120599|SUPERIORITY_OR_OTHER|||||||0.439||95.0||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum|||||||0.439
71809450|NCT00540124|143120600|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.838
71809451|NCT00540124|143120600|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.831
71809452|NCT00540124|143120600|SUPERIORITY_OR_OTHER|||||||0.696||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.696
71809453|NCT00540124|143120600|SUPERIORITY_OR_OTHER|||||||0.257||95.0||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.257
71809454|NCT00540124|143120601|SUPERIORITY_OR_OTHER|||||||0.709||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.709
71809455|NCT00540124|143120601|SUPERIORITY_OR_OTHER|||||||0.494||95.0||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA|||||||0.494
71809456|NCT01163097|143120602|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence of the treatments was assessed using the 90% confidence interval (CI) of the geometric mean ratio for Ki67. The lower bound of the CI needed to be greater than 0.70 and the upper bound needed to be below 1.43 for the treatments to be considered equivalent.|Geometric mean ratio|0.863|||||TWO_SIDED|90.0|0.759|0.982|||ANCOVA|ANCOVA was used to estimate the treatment effect and the Schuirmann's two one-sided test was used to test for statistical equivalence.||H0: mean ratio\<0.7 or mean ratio\>1.43; H1: 0.7\< mean ratio \<1.43 Sample size calculation assumed change in Ki67 expression following palifermin administration would not be affected by co-administration of heparin. With n=26 (13 + 13), an approx. 80% probability that the 90% CI of the ratio of geometric means of Ki67 for palifermin when co-administered with heparin compared to palifermin alone would fall in the interval (0.7, 1.43). This assumed a Coefficient of Variation (CV) for Ki67 of 31%.||0.982|0.759|
71809457|NCT01163097|143120604|SUPERIORITY_OR_OTHER||Geometric mean|0.737|||||TWO_SIDED|95.0|0.614|0.885|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 20% increase (or 17% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of amylase would be 14% (as observed in other study)||0.885|0.614|
71809458|NCT01163097|143120605|SUPERIORITY_OR_OTHER||Geometric mean|0.373|||||TWO_SIDED|95.0|0.216|0.645|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 70% increase (or 41% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of lipase would be 49% (as observed in other study)||0.645|0.216|
71809459|NCT01163097|143120606|SUPERIORITY_OR_OTHER||Geometric mean|0.972|||||TWO_SIDED|95.0|0.768|1.231|||ANCOVA|ANCOVA (with dependent variable:natural log of the ratio to baseline, independent variable:treatment, covariate:natural log of the baseline value)||80% power achieved for detecting a 140% increase with 13 and 6 subjects (respectively) when Treatment B was compared to Treatment C; assuming that the coefficient of variation of the protein/creatinine ratio would be 67% (Ginsberg et al 1983)||1.231|0.768|
71809460|NCT01163097|143120607|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
71809461|NCT01163097|143120608|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
71809462|NCT01163097|143120609|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
71809463|NCT01163097|143120610|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
71809464|NCT01163097|143120611|SUPERIORITY_OR_OTHER|||||||0.4123||90.0|||||ANOVA|||||||0.4123
71809465|NCT01163097|143120612|SUPERIORITY_OR_OTHER|||||||0.9944||90.0|||||ANOVA|||||||0.9944
71809466|NCT01163097|143120613|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
71809467|NCT01163097|143120614|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0|||||ANOVA|||||||<0.0001
71809468|NCT01239030|143120649|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046|||||||ANCOVA|||||||0.0046
71843715|NCT01074294|143201210|SUPERIORITY||Mean Difference (Final Values)|17.51||||0.0298|TWO_SIDED|95.0|1.73|33.29||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||33.29|1.73|0.0298
71809469|NCT01212770|143120650|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|22.3|||<|0.0001|TWO_SIDED|95.0|13.0|31.6|||Cochran-Mantel-Haenszel|Adjusted for baseline disease modifying antirheumatic drug (DMARD) use and and ≥ 3% body surface area (BSA) psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|The percentage of participants with an ACR20 response was compared using a Cochran-Mantel- Haenszel (CMH) test. The Hochberg procedure was used to maintain the Type 1 error at the 0.05 significance level. The results were considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||31.6|13.0|<0.0001
71809470|NCT01212770|143120650|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|9.8||||0.0295|TWO_SIDED|95.0|1.1|18.6|||Cochran-Mantel-Haenszel|2-sided p-value based on the Cochran-Mantel-Haenszel test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.||18.6|1.1|0.0295
71809471|NCT01212770|143120651|SUPERIORITY||LS Mean Difference|-0.127||||0.0073|TWO_SIDED|95.0|-0.22|-0.034|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||-0.034|-0.220|0.0073
71843716|NCT01074294|143201211|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.2563|TWO_SIDED|95.0|-0.05|0.01||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.01|-0.05|0.2563
71676248|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.27||0.18|TWO_SIDED|95.0|0.15|1.44||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||1.44|0.15|0.18
71809472|NCT01212770|143120651|SUPERIORITY||LS Mean Difference|-0.066||||0.1619|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.||0.027|-0.158|0.1619
71809473|NCT01212770|143120652|SUPERIORITY||Adjusted Difference|15.5||||0.0007|TWO_SIDED|95.0|6.7|24.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||24.3|6.7|0.0007
71809474|NCT01212770|143120652|SUPERIORITY||Adjusted Difference|11.1||||0.011|TWO_SIDED|95.0|2.7|19.5||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||19.5|2.7|0.0110
71809475|NCT01212770|143120653|SUPERIORITY||LS Mean Difference|-0.139||||0.005|TWO_SIDED|95.0|-0.236|-0.042|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-0.042|-0.236|0.0050
71809476|NCT01212770|143120653|SUPERIORITY||LS Mean Difference|-0.084||||0.086|TWO_SIDED|95.0|-0.181|0.012|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||0.012|-0.181|0.0860
71809477|NCT01212770|143120654|SUPERIORITY||LS Mean Difference|2.32||||0.0053|TWO_SIDED|95.0|0.69|3.95|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||3.95|0.69|0.0053
71843717|NCT01074294|143201212|SUPERIORITY||Mean Difference (Final Values)|-5.67||||0.6644|TWO_SIDED|95.0|-31.4|20.06||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||20.06|-31.4|0.6644
71809478|NCT01212770|143120654|SUPERIORITY||LS mean Difference|1.15||||0.1658|TWO_SIDED|95.0|-0.48|2.77|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||2.77|-0.48|0.1658
71809479|NCT01212770|143120655|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.4|||<|0.0001|TWO_SIDED|95.0|15.5|35.3|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||35.3|15.5|<0.0001
71809480|NCT01212770|143120655|SUPERIORITY||Adjusted Difference|10.4||||0.0372|TWO_SIDED|95.0|0.8|20.0|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||20.0|0.8|0.0372
71843718|NCT01074294|143201213|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.8418|TWO_SIDED|95.0|-0.56|0.45||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.45|-0.56|0.8418
71809481|NCT01212770|143120656|SUPERIORITY||Adjusted Difference|14.6||||0.0062|TWO_SIDED|95.0|4.5|24.8|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||24.8|4.5|0.0062
71809482|NCT01212770|143120656|SUPERIORITY||Adjusted Difference|13.0||||0.0134|TWO_SIDED|95.0|3.0|23.1|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||23.1|3.0|0.0134
71809483|NCT01212770|143120657|SUPERIORITY||LS Mean Difference|-7.8||||0.0021|TWO_SIDED|95.0|-12.8|-2.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||-2.9|-12.8|0.0021
71809484|NCT01212770|143120657|SUPERIORITY||LS Mean Difference|-3.6||||0.1482|TWO_SIDED|95.0|-8.6|1.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.||1.3|-8.6|0.1482
71809485|NCT01212770|143120658|SUPERIORITY||LS Mean Difference|-0.2||||0.5349|TWO_SIDED|95.0|-1.0|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.0|0.5349
71809486|NCT01212770|143120658|SUPERIORITY||LS Mean Difference|0.1||||0.8231|TWO_SIDED|95.0|-0.7|0.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.9|-0.7|0.8231
71809487|NCT01212770|143120659|SUPERIORITY||LS Mean Difference|-0.8||||0.072|TWO_SIDED|95.0|-1.7|0.1|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.1|-1.7|0.0720
71809488|NCT01212770|143120659|SUPERIORITY||LS Mean Difference|-0.4||||0.3641|TWO_SIDED|95.0|-1.3|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.5|-1.3|0.3641
71809489|NCT01212770|143120660|SUPERIORITY||LS Mean Difference|-4.94||||0.0001|TWO_SIDED|95.0|-7.34|-2.53|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.53|-7.34|0.0001
71809490|NCT01212770|143120660|SUPERIORITY||LS Mean Difference|-1.85||||0.1325|TWO_SIDED|95.0|-4.27|0.56|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.56|-4.27|0.1325
71809491|NCT01212770|143120661|SUPERIORITY||LS Mean Difference|-0.47||||0.0001|TWO_SIDED|95.0|-0.7|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.70|0.0001
71843719|NCT01074294|143201214|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2513|TWO_SIDED|95.0|-0.69|0.18||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.18|-0.69|0.2513
71843720|NCT01074294|143201215|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.7037|TWO_SIDED|95.0|-0.48|0.71||The p-value was derived from ANCOVA model, with treatment and study center as main effects and week 5 value as covariate, is used for change from week 5 comparisons.|ANCOVA||The difference between LS means derived from the ANCOVA model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|||0.71|-0.48|0.7037
71843721|NCT01074294|143201216|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.7572|TWO_SIDED|95.0|-0.17|0.23||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||0.23|-0.17|0.7572
71843722|NCT01074294|143201216|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.6132|TWO_SIDED|95.0|-0.28|0.17||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||0.17|-0.28|0.6132
71843723|NCT01074294|143201216|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9312|TWO_SIDED|95.0|-0.25|0.27||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||0.27|-0.25|0.9312
71843724|NCT01074294|143201216|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.8073|TWO_SIDED|95.0|-0.3|0.24||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||0.24|-0.30|0.8073
71843725|NCT01074294|143201216|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.9168|TWO_SIDED|95.0|-0.26|0.29||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||0.29|-0.26|0.9168
71809492|NCT01212770|143120661|SUPERIORITY||LS Mean Difference|-0.27||||0.0237|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.04|-0.50|0.0237
71809493|NCT01212770|143120662|SUPERIORITY||LS Mean Difference|2.54||||0.0049|TWO_SIDED|95.0|0.77|4.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.30|0.77|0.0049
71809494|NCT01212770|143120662|SUPERIORITY||LS Mean Difference|0.68||||0.4505|TWO_SIDED|95.0|-1.09|2.44|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.44|-1.09|0.4505
71809495|NCT01212770|143120663|SUPERIORITY||LS Mean Difference|2.34||||0.0043|TWO_SIDED|95.0|0.74|3.94|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.94|0.74|0.0043
71809496|NCT01212770|143120663|SUPERIORITY||LS Mean Difference|1.67||||0.0404|TWO_SIDED|95.0|0.07|3.27|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||3.27|0.07|0.0404
71809497|NCT01212770|143120664|SUPERIORITY||Adjusted Difference|21.2|||<|0.0001|TWO_SIDED|95.0|11.5|30.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||30.9|11.5|< 0.0001
71843726|NCT01074294|143201216|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7432|TWO_SIDED|95.0|-0.34|0.25||The p-value was derived from CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||0.25|-0.34|0.7432
71809498|NCT01212770|143120664|SUPERIORITY||Adjusted Difference|8.7||||0.0661|TWO_SIDED|95.0|-0.5|18.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||18.0|-0.5|0.0661
71809499|NCT01212770|143120665|SUPERIORITY||Adjusted Difference|14.8||||0.0099|TWO_SIDED|95.0|3.8|25.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.7|3.8|0.0099
71809500|NCT01212770|143120665|SUPERIORITY||Adjusted Difference|10.8||||0.0515|TWO_SIDED|95.0|0.1|21.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.4|0.1|0.0515
71809501|NCT01212770|143120666|SUPERIORITY||LS mean Difference|-6.6||||0.008|TWO_SIDED|95.0|-11.4|-1.7|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-1.7|-11.4|0.0080
71809502|NCT01212770|143120666|SUPERIORITY||LS Mean Difference|-3.8||||0.1218|TWO_SIDED|95.0|-8.6|1.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||1.0|-8.6|0.1218
71809503|NCT01212770|143120667|SUPERIORITY||LS Mean Difference|-0.4||||0.2761|TWO_SIDED|95.0|-1.3|0.4|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.4|-1.3|0.2761
71809504|NCT01212770|143120667|SUPERIORITY||LS Mean Difference|-0.3||||0.5012|TWO_SIDED|95.0|-1.1|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.1|0.5012
71809505|NCT01212770|143120668|SUPERIORITY||LS Mean Difference|-1.0||||0.0399|TWO_SIDED|95.0|-1.9|0.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.0|-1.9|0.0399
71809506|NCT01212770|143120668|SUPERIORITY||LS Mean Difference|-0.4||||0.4413|TWO_SIDED|95.0|-1.3|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||0.6|-1.3|0.4413
71809507|NCT01212770|143120669|SUPERIORITY||LS Mean Difference|-5.27|||<|0.0001|TWO_SIDED|95.0|-7.73|-2.82|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-2.82|-7.73|< 0.0001
71809508|NCT01212770|143120669|SUPERIORITY||LS Mean Difference|-2.65||||0.0349|TWO_SIDED|95.0|-5.11|-0.19|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.19|-5.11|0.0349
71843727|NCT01074294|143201217|SUPERIORITY||Risk Ratio (RR)|1.2||||0.6014|TWO_SIDED|95.0|0.6|2.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.42|0.60|0.6014
71843728|NCT01074294|143201217|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9225|TWO_SIDED|95.0|0.64|1.63||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.63|0.64|0.9225
71809509|NCT01212770|143120670|SUPERIORITY||LS Mean Difference|-0.48||||0.0001|TWO_SIDED|95.0|-0.72|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.24|-0.72|0.0001
71676249|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.3||0.99|TWO_SIDED|95.0|0.08|12.57||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||12.57|0.08|0.99
71677365|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.656|||||TWO_SIDED|95.0|2.764|4.836||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.836|2.764|
71809510|NCT01212770|143120670|SUPERIORITY||LS Mean Difference|-0.3||||0.0147|TWO_SIDED|95.0|-0.54|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||-0.06|-0.54|0.0147
71809511|NCT01212770|143120671|SUPERIORITY||LS Mean Difference|2.44||||0.0078|TWO_SIDED|95.0|0.64|4.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||4.24|0.64|0.0078
71809512|NCT01212770|143120671|SUPERIORITY||LS Mean Difference|1.19||||0.1936|TWO_SIDED|95.0|-0.61|2.98|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||||2.98|-0.61|0.1936
71809513|NCT01212770|143120672|SUPERIORITY||Adjusted Difference|2.1||||0.7585|TWO_SIDED|95.0|-10.9|15.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.0|-10.9|0.7585
71809514|NCT01212770|143120672|SUPERIORITY||Adjusted Difference|-3.9||||0.5808|TWO_SIDED|95.0|-17.4|9.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||9.7|-17.4|0.5808
71809515|NCT01212770|143120673|SUPERIORITY||Adjusted Difference|12.0||||0.1303|TWO_SIDED|95.0|-3.1|27.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD useinvolvement of \>= 3% BSA with psoriasis at baseline..|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||27.0|-3.1|0.1303
71809516|NCT01212770|143120673|SUPERIORITY||Adjusted Difference|7.5||||0.361|TWO_SIDED|95.0|-8.3|23.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||23.2|-8.3|0.3610
71809517|NCT01212770|143120674|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|12.4|32.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.6|12.4|< 0.0001
71809518|NCT01212770|143120674|SUPERIORITY||Adjusted Difference|11.0||||0.0309|TWO_SIDED|95.0|1.2|20.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.9|1.2|0.0309
71809519|NCT01212770|143120675|SUPERIORITY||Adjusted Difference|3.8||||0.5731|TWO_SIDED|95.0|-9.1|16.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||16.7|-9.1|0.5731
71809520|NCT01212770|143120675|SUPERIORITY||Adjusted Difference|1.0||||0.8876|TWO_SIDED|95.0|-12.6|14.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||14.6|-12.6|0.8876
71809521|NCT01212770|143120676|SUPERIORITY||Adjusted Difference|12.2||||0.1172|TWO_SIDED|95.0|-2.5|26.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||26.9|-2.5|0.1172
71676250|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.52||0.86|TWO_SIDED|95.0|0.29|2.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.||These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||2.82|0.29|0.86
71809522|NCT01212770|143120676|SUPERIORITY||Adjusted Difference|7.2||||0.3695|TWO_SIDED|95.0|-8.2|22.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||22.6|-8.2|0.3695
71809523|NCT01212770|143120677|SUPERIORITY||Adjusted Difference|22.5|||<|0.0001|TWO_SIDED|95.0|13.0|32.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||32.1|13.0|< 0.0001
71809524|NCT01212770|143120677|SUPERIORITY||Adjusted Difference|11.7||||0.0123|TWO_SIDED|95.0|2.7|20.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||20.7|2.7|0.0123
71809525|NCT01212770|143120678|SUPERIORITY||Adjusted Difference|6.8||||0.052|TWO_SIDED|95.0|0.0|13.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||13.5|0.0|0.0520
71809526|NCT01212770|143120678|SUPERIORITY||Adjusted Difference|4.2||||0.2052|TWO_SIDED|95.0|-2.2|10.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||10.6|-2.2|0.2052
71809527|NCT01212770|143120679|SUPERIORITY||Adjusted Difference|1.2||||0.5154|TWO_SIDED|95.0|-2.4|4.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.8|-2.4|0.5154
71809528|NCT01212770|143120679|SUPERIORITY||Adjusted Difference|2.3||||0.2527|TWO_SIDED|95.0|-1.5|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-1.5|0.2527
71843729|NCT01074294|143201217|SUPERIORITY||Risk Ratio (RR)|0.86||||0.4803|TWO_SIDED|95.0|0.58|1.3||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.30|0.58|0.4803
71809529|NCT01212770|143120680|SUPERIORITY||Adjusted Difference|8.3||||0.018|TWO_SIDED|95.0|1.6|15.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||15.1|1.6|0.0180
71809530|NCT01212770|143120680|SUPERIORITY||Adjusted Difference|5.8||||0.0807|TWO_SIDED|95.0|-0.6|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||12.3|-0.6|0.0807
71809531|NCT01212770|143120681|SUPERIORITY||Adjusted Difference|1.8||||0.423|TWO_SIDED|95.0|-2.6|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.2|-2.6|0.4230
71809532|NCT01212770|143120681|SUPERIORITY||Adjusted Difference|0.6||||0.787|TWO_SIDED|95.0|-3.5|4.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||4.6|-3.5|0.7870
71843730|NCT01074294|143201217|SUPERIORITY||Risk Ratio (RR)|0.91||||0.5876|TWO_SIDED|95.0|0.65|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.27|0.65|0.5876
71676251|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.43||0.8045|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be lower in the insert groups than in the no insert groups.||||0.8045
71676252|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|2.53|STANDARD_ERROR_OF_MEAN|1.01||0.0205|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||||0.0205
71676253|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|0.53|STANDARD_ERROR_OF_MEAN|0.26||0.1918|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results from the multiple imputation model are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be lower in the insert and pictorial warning group than in the pictorial warning only group.||||0.1918
71676254|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|1.12||0.99|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be lower for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4).||||0.99
71676255|NCT04075682|142870125|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|1.54||0.6873|TWO_SIDED|||||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083.|Mixed Models Analysis|We estimated mixed-effects logistic regression models that accounted for repeated measures at the individual level.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are from the multiple imputation model for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||||0.6873
71809533|NCT01212770|143120682|SUPERIORITY||Adjusted Difference|-4.1||||0.4707|TWO_SIDED|95.0|-14.8|6.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||6.5|-14.8|0.4707
71809534|NCT01212770|143120682|SUPERIORITY||Adjusted Difference|-5.4||||0.3547|TWO_SIDED|95.0|-16.6|5.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||5.7|-16.6|0.3547
71809535|NCT01212770|143120683|SUPERIORITY||Adjusted Difference|6.6||||0.4175|TWO_SIDED|95.0|-8.6|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-8.6|0.4175
71809536|NCT01212770|143120683|SUPERIORITY||Adjusted Difference|6.4||||0.437|TWO_SIDED|95.0|-9.1|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||21.8|-9.1|0.4370
71809537|NCT01212770|143120684|SUPERIORITY||Adjusted Difference|-0.4||||0.9463|TWO_SIDED|195.0|-12.1|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||11.3|-12.1|0.9463
71809538|NCT01212770|143120684|SUPERIORITY||Adjusted Difference|-7.7||||0.2032|TWO_SIDED|95.0|-19.3|3.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||3.8|-19.3|0.2032
71809539|NCT01212770|143120685|SUPERIORITY||Adjusted Difference|9.8||||0.2321|TWO_SIDED|95.0|-5.8|25.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.4|-5.8|0.2321
71809540|NCT01212770|143120685|SUPERIORITY||Adjusted Difference|9.6||||0.252|TWO_SIDED|95.0|-6.2|25.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of \>= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|||25.3|-6.2|0.2520
71843731|NCT01074294|143201217|SUPERIORITY||Risk Ratio (RR)|0.87||||0.3727|TWO_SIDED|95.0|0.64|1.18||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.18|0.64|0.3727
71843732|NCT01074294|143201217|SUPERIORITY||Risk Ratio (RR)|0.93||||0.6265|TWO_SIDED|95.0|0.71|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.71|0.6265
71843733|NCT01074294|143201218|SUPERIORITY||Risk Ratio (RR)|1.1||||0.8586|TWO_SIDED|95.0|0.4|3.03||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.03|0.40|0.8586
71843734|NCT01074294|143201218|SUPERIORITY||Risk Ratio (RR)|0.95||||0.8984|TWO_SIDED|95.0|0.46|1.99||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||1.99|0.46|0.8984
71843735|NCT01074294|143201218|SUPERIORITY||Risk Ratio (RR)|0.99||||0.9778|TWO_SIDED|95.0|0.57|1.74||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.74|0.57|0.9778
71843736|NCT01074294|143201218|SUPERIORITY||Risk Ratio (RR)|0.92||||0.7315|TWO_SIDED|95.0|0.56|1.5||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.50|0.56|0.7315
71843737|NCT01074294|143201218|SUPERIORITY||Risk Ratio (RR)|0.9||||0.6518|TWO_SIDED|95.0|0.57|1.42||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.42|0.57|0.6518
71843738|NCT01074294|143201218|SUPERIORITY||Risk Ratio (RR)|0.82||||0.3472|TWO_SIDED|95.0|0.55|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.23|0.55|0.3472
71843739|NCT01074294|143201219|SUPERIORITY||Risk Ratio (RR)|0.98||||0.9577|TWO_SIDED|95.0|0.44|2.16||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.16|0.44|0.9577
71843740|NCT01074294|143201219|SUPERIORITY||Risk Ratio (RR)|1.19||||0.5864|TWO_SIDED|95.0|0.63|2.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.27|0.63|0.5864
71809541|NCT00829387|143120706|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.39||||0.47|TWO_SIDED|95.0|-1.47|0.69|||Linear mixed model|||||0.69|-1.47|0.47
71809542|NCT00829387|143120707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.4|TWO_SIDED|95.0|-1.15|0.47|||linear mixed model|||baseline to 36 weeks post-baseline||0.47|-1.15|0.40
71809543|NCT00829387|143120708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.31|TWO_SIDED|95.0|-7.02|2.32|||Linear mixed model|||baseline to 12 weeks post-baseline||2.32|-7.02|0.31
71809544|NCT00829387|143120709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-1.03|1.06|||linear mixed model|||baseline to 12 weeks comparison||1.06|-1.03|0.98
71809545|NCT00829387|143120710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.03|TWO_SIDED|95.0|-1.76|-0.07|||linear mixed model|||baseline to 36 weeks post-baseline||-0.07|-1.76|0.03
71809546|NCT00829387|143120711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16||||0.15|TWO_SIDED|95.0|-9.86|1.55|||linear mixed model|||baseline to 36 weeks post-baseline||1.55|-9.86|0.15
71843741|NCT01074294|143201219|SUPERIORITY||Risk Ratio (RR)|0.96||||0.8723|TWO_SIDED|95.0|0.57|1.6||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.60|0.57|0.8723
71843742|NCT01074294|143201219|SUPERIORITY||Risk Ratio (RR)|1.0||||0.9872|TWO_SIDED|95.0|0.65|1.52||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.52|0.65|0.9872
71843743|NCT01074294|143201219|SUPERIORITY||Risk Ratio (RR)|0.8||||0.3171|TWO_SIDED|95.0|0.52|1.23||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.23|0.52|0.3171
71843744|NCT01074294|143201219|SUPERIORITY||Risk Ratio (RR)|0.87||||0.4782|TWO_SIDED|95.0|0.6|1.27||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.27|0.60|0.4782
71843745|NCT01074294|143201220|SUPERIORITY||Risk Ratio (RR)|1.19||||0.7232|TWO_SIDED|95.0|0.45|3.19||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||3.19|0.45|0.7232
71843746|NCT01074294|143201220|SUPERIORITY||Risk Ratio (RR)|0.99||||0.986|TWO_SIDED|95.0|0.46|2.13||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.13|0.46|0.9860
71843747|NCT01074294|143201220|SUPERIORITY||Risk Ratio (RR)|1.01||||0.9858|TWO_SIDED|95.0|0.52|1.95||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.95|0.52|0.9858
71843748|NCT01074294|143201220|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9466|TWO_SIDED|95.0|0.58|1.78||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.78|0.58|0.9466
71843749|NCT01074294|143201220|SUPERIORITY||Risk Ratio (RR)|1.12||||0.6962|TWO_SIDED|95.0|0.63|2.0||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||2.00|0.63|0.6962
71843750|NCT01074294|143201220|SUPERIORITY||Risk Ratio (RR)|0.93||||0.7637|TWO_SIDED|95.0|0.57|1.51||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.51|0.57|0.7637
71843751|NCT01074294|143201221|SUPERIORITY||Risk Ratio (RR)|1.3||||0.3631|TWO_SIDED|95.0|0.73|2.33||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 6||2.33|0.73|0.3631
71843752|NCT01074294|143201221|SUPERIORITY||Risk Ratio (RR)|1.35||||0.2786|TWO_SIDED|95.0|0.78|2.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 7||2.35|0.78|0.2786
71843753|NCT01074294|143201221|SUPERIORITY||Risk Ratio (RR)|1.08||||0.7062|TWO_SIDED|95.0|0.72|1.62||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 8||1.62|0.72|0.7062
71843754|NCT01074294|143201221|SUPERIORITY||Risk Ratio (RR)|0.95||||0.7844|TWO_SIDED|95.0|0.67|1.35||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 9||1.35|0.67|0.7844
71843755|NCT01074294|143201221|SUPERIORITY||Risk Ratio (RR)|1.07||||0.694|TWO_SIDED|95.0|0.77|1.48||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 10||1.48|0.77|0.6940
71843756|NCT01074294|143201221|SUPERIORITY||Risk Ratio (RR)|1.03||||0.8697|TWO_SIDED|95.0|0.76|1.39||The p-value was derived from CMH general association test controlling for study center.|Cochran-Mantel-Haenszel||The difference between LS means derived from the CMH model. This comparison was tested for statistical significance at a 0.05 (two-sided) significance level.|Week 11||1.39|0.76|0.8697
71843757|NCT01260896|143201239|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.84|||||TWO_SIDED|90.0|100.54|113.54|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||113.54|100.54|
71809547|NCT01951625|143120744|OTHER||Log-Scale mean difference|-0.122|||=|0.1506|TWO_SIDED|90.0|-0.32|0.07|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test at the significance level of 5 percent (%). Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the pooled treatment group and the placebo group is difference of means on the log scale.||0.07|-0.32|= 0.1506
71843758|NCT01260896|143201240|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.34|||||TWO_SIDED|90.0|100.37|110.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||110.55|100.37|
71843759|NCT01260896|143201241|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.12|||||TWO_SIDED|90.0|97.8|108.73|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.73|97.80|
71895301|NCT00847613|143312932|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05||0.0002|TWO_SIDED|95.0|-0.34|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in mTSS had to be statistically significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.16|-0.34|0.0002
71809548|NCT01951625|143120744|OTHER||Log-Scale mean difference|-0.2494|||=|0.0483|TWO_SIDED|90.0|-0.5|0.0|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0|-0.5|= 0.0483
71809549|NCT01951625|143120744|OTHER||Log-Scale mean difference|-0.0731|||=|0.3042|TWO_SIDED|90.0|-0.31|0.16|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.16|-0.31|= 0.3042
71809550|NCT01951625|143120744|OTHER||Log-Scale mean difference|-0.0396|||=|0.3841|TWO_SIDED|90.0|-0.26|0.18|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only, since the primary analyses were not significant.||0.18|-0.26|= 0.3841
71809551|NCT01951625|143120744|OTHER||Log-Scale mean difference|0.0151|||=|0.5444|TWO_SIDED|90.0|-0.21|0.24|||t-test, 1 sided|||In case of a significant result in the primary analysis of the primary endpoint, pairwise comparisons to Placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In case of non-significance of the primary analyses, these secondary analyses were specified as exploratory only.||0.24|-0.21|= 0.5444
71809552|NCT02459574|143120759|SUPERIORITY||Hazard Ratio (HR)|0.156|||<|0.0001|TWO_SIDED|95.0|0.097|0.25||Bonferonni corrected alpha of 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Anti-Arrhythmic Therapy|Primary Analysis - AVATAR-AF vs Anti-Arrhythmic Therapy||0.250|0.097|<0.0001
71809553|NCT02459574|143120759|SUPERIORITY||Hazard Ratio (HR)|1.173||||0.6061|TWO_SIDED|95.0|0.639|2.154||Bonferonni corrected alpha 0.05/2 = 0.025|Log Rank||95% Wald Confidence Limits Point estimate relates to AVATAR-AF in relation to Conventional Ablation|Secondary analysis of Primary Outcome measure - AVATAR-AF vs Conventional Ablation||2.154|0.639|0.6061
71809554|NCT00251745|143120763|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71809555|NCT00251745|143120763|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71809556|NCT00251745|143120763|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
71809557|NCT00251745|143120765|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
71809558|NCT00251745|143120765|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71843760|NCT01260896|143201242|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|114.21|||||TWO_SIDED|90.0|109.29|119.35|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||119.35|109.29|
71843761|NCT01260896|143201243|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|108.26|||||TWO_SIDED|90.0|104.84|111.79|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.79|104.84|
71809559|NCT00251745|143120765|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
71843762|NCT01260896|143201244|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.75|||||TWO_SIDED|90.0|92.92|102.85|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||102.85|92.92|
71843763|NCT00312208|143201248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.978||95.0|0.86|1.16||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.16|0.86|0.978
71843764|NCT00312208|143201249|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.371||95.0|0.75|1.11||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates.|Log Rank|||||1.11|0.75|0.371
71843765|NCT04612244|143201295|NON_INFERIORITY|"PT will be deemed to be non-inferior to PC if it can be established that the posterior probability Pr(HA \| data) \> Ψeff, where Ψeff is a pre-specified threshold value that controls the one-sided type I error rate (under simulation) at level 0.05. In the absence of missing data, the posterior distributions for PT and PC would be conjugate Beta distributions."||||||0.05|||||||t-test, 1 sided|||"The primary effectiveness endpoint for this study is Treatment Success, which will be analyzed as a test of non-inferiority of the event rate at 12 months using a noninferiority margin of 15%.~The null and alternative hypotheses are:~H0: PT ≤ PC - 0.15 versus HA: PT \> PC - 0.15 where PT is the Treatment Success rate at 12 months in the Pulsed Field Group and PC is the Treatment Success rate at 12 months in the Thermal (Control) Group."||||0.05
71843766|NCT04612244|143201297|SUPERIORITY|"The null and alternative hypotheses are provided below. H0: PT ≤ PC versus HA: PT \> PC where PT is the Treatment Success rate at 12 months in the Pulsed Field Group, and PC is the Treatment Success rate at 12 months in the Thermal Group.~Modeling will be identical primary endpoint and superiority concluded if the posterior probability Pr(HA \| data) \> Ψeff, sup, where the threshold Ψeff,sup is a pre-specified threshold value that controls the one-sided type I error rate at level 0.025."|Median Difference (Final Values)|0.708||||0.025|ONE_SIDED|97.5|||||t-test, 1 sided|||The secondary effectiveness endpoint for the ADVENT Trial is Treatment Superiority uses the same definition as the primary effectiveness endpoint for Treatment Success, but the test is for superiority between MITT subjects in the PFA and Thermal Groups.||||0.025
71843767|NCT03170648|143201301|OTHER|||||||0.02||||||T2 (post) vs.T1(pre)|t-test, 2 sided|||||||0.02
71843768|NCT03509909|143201303|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71843769|NCT03500549|143201309|SUPERIORITY|The primary endpoint analysis was a between-treatment-group comparison using a mixed effect model for repeated measures (MMRM). The difference between pegcetacoplan and eculizumab LS mean Hb changes from Baseline at Week 16 was calculated along with its 2-sided 95% confidence interval (CI) and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|3.84|||<|0.0001|TWO_SIDED|95.0|2.33|5.34||Superiority was tested at the 5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||5.34|2.33|<0.0001
71843770|NCT03500549|143201310|NON_INFERIORITY|Analysis was based on prespecified non-inferiority margins (NIM) and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of -20%. Stratified Cochran-Mantel Haenszel (CMH) chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified (Miettinen-Nurminen) method.|Risk Difference (RD)|0.6253|||<|0.0001|TWO_SIDED|95.0|0.483|0.7677||Non-inferiority was tested at the 2.5% level.|Miettinen-Nurminen|||||0.7677|0.4830|<0.0001
71843771|NCT03500549|143201311|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 10.|LS mean difference|-163.61|||<|0.0001|TWO_SIDED|95.0|-189.91|-137.3||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-137.30|-189.91|<0.0001
71809560|NCT00636649|143120769|SUPERIORITY_OR_OTHER|||||||0.993|||||||ANCOVA|||CISS-TASK||||0.993
71809561|NCT00636649|143120769|SUPERIORITY_OR_OTHER|||||||0.185|||||||ANCOVA|||CISS-EMOT||||0.185
71809562|NCT00636649|143120769|SUPERIORITY_OR_OTHER|||||||0.196|||||||ANCOVA|||CISS-DIS||||0.196
71809563|NCT00636649|143120769|SUPERIORITY_OR_OTHER|||||||0.759|||||||ANCOVA|||CISS-AVD||||0.759
71809564|NCT00636649|143120769|SUPERIORITY_OR_OTHER|||||||0.396|||||||ANCOVA|||CISS-SOC||||0.396
71809565|NCT00636649|143120770|SUPERIORITY_OR_OTHER|||||||0.579|||||||ANCOVA|||||||0.579
71809566|NCT00636649|143120771|SUPERIORITY_OR_OTHER|||||||0.225|||||||ANCOVA|||TFEQ-RES||||0.225
71676256|NCT04075682|142870126|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.39||0.37|TWO_SIDED|95.0|-1.12|0.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Mixed Models Analysis|We estimated mixed-effects ordinal regression models that accounted for repeated measures at both the day- and individual-levels.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||0.41|-1.12|0.37
71676257|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.05||0.92|TWO_SIDED|95.0|0.9|1.1||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H1 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received inserts (insert only AND insert + pictorial warnings) with the groups that did not (pictorial warning only AND control). We expected that the outcome would be higher in the insert groups than in the no insert groups.||1.10|0.90|0.92
71676258|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.95|TWO_SIDED|95.0|0.9|1.11||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H2 assessment (see Statistical Analysis Plan, Model 1), comparing groups that received pictorial warnings (pictorial warning only AND insert + pictorial warnings) with the groups that did not (insert only AND control). We expected that the outcome would be higher in the pictorial warning groups than in the no pictorial warning groups.||1.11|0.90|0.95
71676259|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.08||0.85|TWO_SIDED|95.0|0.85|1.14||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H3 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received inserts only. We expected that this outcome would be higher in the insert and pictorial warning group than in the insert only group.||1.14|0.85|0.85
71809567|NCT00636649|143120771|SUPERIORITY_OR_OTHER|||||||0.498|||||||ANCOVA|||TFEQ-DIS||||0.498
71809568|NCT00636649|143120771|SUPERIORITY_OR_OTHER|||||||0.724|||||||ANCOVA|||TFEQ-HUN||||0.724
71809569|NCT04508699|143120779|OTHER|||||||0.36|||||||t-test, 1 sided|||||||0.36
71809570|NCT04508699|143120780|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
71809571|NCT04508699|143120781|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
71809572|NCT04508699|143120782|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
71809573|NCT04508699|143120783|OTHER||||||<|0.05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|ANOVA|||||||<0.05
71809574|NCT04508699|143120784|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
71809575|NCT04508699|143120785|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
71809576|NCT04508699|143120786|OTHER||||||<|1e-05||||||reported p-value was calculated, is not indicating the threshold for statistical significance.|t-test, 1 sided|||||||<0.00001
71809577|NCT03355326|143120815|SUPERIORITY|||||||0.971|||||||Wilcoxon (Mann-Whitney)|||||||0.971
71809578|NCT03355326|143120816|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.900
71809579|NCT03355326|143120817|SUPERIORITY|||||||0.648|||||||Wilcoxon (Mann-Whitney)|||||||0.648
71809580|NCT03355326|143120818|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||||||0.967
71809581|NCT03355326|143120819|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71809582|NCT03355326|143120820|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71809583|NCT03355326|143120821|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71809584|NCT04333420|143120822|SUPERIORITY||LS means difference|-16.4||||0.3677|TWO_SIDED|95.0|-53.2|20.3|||Linear repeated measures model|||||20.3|-53.2|0.3677
71809585|NCT04333420|143120823|SUPERIORITY||Hazard Ratio (HR)|0.728||||0.0941|TWO_SIDED|95.0|0.502|1.056|||Regression, Cox|including stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by site; 61 patients from sites with no events (no death) or from single patient sites with death factually make no contribution to the analysis outcome.||1.056|0.502|0.0941
71809586|NCT04333420|143120823|SUPERIORITY||Hazard Ratio (HR)|0.674||||0.0266|TWO_SIDED|95.0|0.476|0.955|||Regression, Cox|Without stratification by site||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) without stratification by site; Post-hoc analysis||0.955|0.476|0.0266
71809587|NCT04333420|143120823|SUPERIORITY||Hazard Ratio (HR)|0.648||||0.0181|TWO_SIDED|95.0|0.453|0.929|||Regression, Cox|Including random effect for site (frailty model)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including random effect for site (frailty model); Post-hoc analysis||0.929|0.453|0.0181
71676260|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.07||0.75|TWO_SIDED|95.0|0.84|1.13||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the pre-specified H4 assessment (see Statistical Analysis Plan, Model 1), comparing the group that received inserts and pictorial warnings with the group that received pictorial warnings only. We expected that this outcome would be higher in the insert and pictorial warning group than in the pictorial warning only group.||1.13|0.84|0.75
71676261|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.97|STANDARD_ERROR_OF_MEAN|0.11||0.78|TWO_SIDED|95.0|0.78|1.2||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5a assessment, which evaluates moderation of the pre-specified H2 assessment. We expected that the effect of pictorial HWLs (averaged over insert) vs no pictorial HWLs (averaged over insert) on the outcome would be stronger for higher vs lower self-efficacy (see Statistical Analysis Plan, Model 4)||1.20|0.78|0.78
71676262|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|0.94|1.82||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H5b assessment, which evaluates whether moderation of pictorial warnings effects would vary by whether the pictorial warnings included inserts or not. We expected that moderation effects of baseline self-efficacy would be larger for pictorial warnings only (vs control) than for pictorial warnings AND inserts (vs control) (see Statistical Analysis Plan, Model 4).||1.82|0.94|0.11
71809588|NCT04333420|143120823|SUPERIORITY||Hazard Ratio (HR)|0.613||||0.0067|TWO_SIDED|95.0|0.43|0.873|||Regression, Cox|Including stratification by country||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death) including stratification by country; Post-hoc analysis||0.873|0.430|0.0067
71809589|NCT04333420|143120823|SUPERIORITY||Risk Difference (RD)|-11.0||||0.0293|TWO_SIDED|95.0|-20.8|-1.2|||Regression, Logistic|Multiple imputation of missing values|Risk difference and lower/upper limit of the Confidence Interval are given in percent|Sensitivity analysis; 369 patients were included in this analysis including the patient that was randomized in error and not treated. Missing values were imputed by multiple imputation.||-1.2|-20.8|0.0293
71809590|NCT04333420|143120823|SUPERIORITY|||||||0.0407|||||||Log Rank|||Post-hoc analysis||||0.0407
71809591|NCT04333420|143120824|SUPERIORITY||Hazard Ratio (HR)|0.651||||0.6494|TWO_SIDED|95.0|0.103|4.135|||Regression, Cox|Covariate: Treatment (IFX-1 + BSC)||Cox proportional hazards regression model with outcome 28-day all-cause mortality (censored time to event variable with event = Death)||4.135|0.103|0.6494
71809592|NCT04333420|143120828|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0815|TWO_SIDED|95.0|0.519|1.039|||Regression, Cox|||Cox proportional hazards regression model with outcome 60-day all-cause mortality (censored time to event variable with event = Death); Covariate: Treatment (IFX-1 + SOC)||1.039|0.519|0.0815
71809593|NCT04333420|143120829|SUPERIORITY||Risk Difference (RD)|7.352||||0.1553|TWO_SIDED|95.0|-2.762|17.465|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 15||17.465|-2.762|0.1553
71809594|NCT04333420|143120829|SUPERIORITY||Risk Difference (RD)|8.078||||0.1181|TWO_SIDED|95.0|-1.968|18.125|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients with an improvement in the 8-point ordinal scale; Risk difference and lower/upper limit of the CI are given in percent|At Day 28||18.125|-1.968|0.1181
71809595|NCT04333420|143120830|SUPERIORITY||Risk Difference (RD)|-2.081||||0.4105|TWO_SIDED|95.0|-6.949|2.787|||Regression, Logistic||Risk difference (IFX-1 - Placebo) of percentage of patients developing acute kidney failure; Risk difference and lower/upper limit of the CI are given in percent|||2.787|-6.949|0.4105
71809596|NCT04333420|143120831|SUPERIORITY||Hazard Ratio (HR)|0.539||||0.0422|TWO_SIDED|95.0|0.297|0.978||p-value refers to hazard ratio from cause-specific Cox proportional hazards model for first renal replacement therapy.|Regression, Cox|Covariate: Treatment (IFX-1 + SOC)||||0.978|0.297|0.0422
71809597|NCT00833560|143120861|SUPERIORITY_OR_OTHER||Percentage of participants with response|85.4|||<|0.0001|TWO_SIDED|95.0|81.5|88.8|||Two - sided binomial test|||||88.8|81.5|<0.0001
71809598|NCT00833560|143120862|SUPERIORITY_OR_OTHER||Percentage of participants with response|87.7|||<|0.0001|TWO_SIDED|95.0|83.6|91.0|||Two-sided binomial test|||||91.0|83.6|<0.0001
71809599|NCT00677833|143120897|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-9.1|||||TWO_SIDED|95.0|-16.02|-2.18|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-2.18|-16.02|
71676263|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.93|TWO_SIDED|95.0|0.8|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower education (see Statistical Analysis Plan, Model 5).||1.22|0.80|0.93
71676264|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.11||0.86|TWO_SIDED|95.0|0.78|1.23||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with higher than lower literacy (see Statistical Analysis Plan, Model 5).||1.23|0.78|0.86
71676265|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.11||0.94|TWO_SIDED|95.0|0.81|1.22||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6a assessment, which evaluates moderation of the pre-specified H1 assessment. We expected that the effect of inserts (averaged over pictorial warnings) compared to no inserts (averaged over pictorial warnings) on the outcome would be stronger for those with lower than higher delayed discounting (see Statistical Analysis Plan, Model 5).||1.22|0.81|0.94
71676266|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.21||0.13|TWO_SIDED|95.0|0.93|1.78||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline education would be stronger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.78|0.93|0.13
71676267|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.18||0.96|TWO_SIDED|95.0|0.7|1.41||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline literacy would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.41|0.70|0.96
71809600|NCT00677833|143120898|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was \>= -10% points.|ACPR percent difference|-6.08|||||TWO_SIDED|95.0|-12.1|-0.05|||Kaplan-Meier curves|||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.||-0.05|-12.10|
71809601|NCT00677833|143120899|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
71843772|NCT03500549|143201312|NON_INFERIORITY|Analysis was based on prespecified NIM and non-inferiority was achieved if the lower confidence limit or upper confidence limit of the 95% CI of the treatment difference met the prespecified NIM of 20.|LS mean difference|-4.63||||0.9557|TWO_SIDED|95.0|-181.3|172.04||Non-inferiority was tested at the 2.5% level. MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||172.04|-181.30|0.9557
71895302|NCT00847613|143312933|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|14.4|||<|0.0001|TWO_SIDED|95.0|9.44|19.36||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||19.36|9.44|<0.0001
71676268|NCT04075682|142870127|OTHER|We conducted a two-sided test for mean (group 1) = mean (group 2) versus means not being equal.|Rate ratio|0.99|STANDARD_ERROR_OF_MEAN|0.16||0.95|TWO_SIDED|95.0|0.72|1.36||The reported p-value is not adjusted. The a priori threshold for statistical significance uses a Bonferroni-adjusted critical value of p\<0.05/6=0.0083|Negative binomial regression|We estimated negative binomial regression models, as there is a single measure for each person and so there are no repeated measures.|To evaluate the study hypothesis, a Wald test was used for the associated regression parameter.|These results are for the intended (but not correctly pre-specified) H6b assessment, which evaluated whether the moderation of insert effects would vary by whether the inserts included pictorial warnings or not. We expected that moderation by baseline delay discounting would be larger for insert only (vs control) than for inserts AND pictorial warnings (vs control) (see Statistical Analysis Plan, Model 5).||1.36|0.72|0.95
71676269|NCT01931475|142870130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||||-0.2|-0.80|
71676270|NCT01931475|142870131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.54|-0.19||||||||-0.19|-0.54|
71676271|NCT01931475|142870132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.49|||||TWO_SIDED|95.0|-5.62|-1.35|||||Total Score|||-1.35|-5.62|
71676272|NCT01931475|142870132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.21|-0.21|||||Pain|||-0.21|-1.21|
71676273|NCT01931475|142870132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36|||||TWO_SIDED|95.0|-3.95|-0.78|||||Physical Function|||-0.78|-3.95|
71676274|NCT01931475|142870132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.62|-0.16|||||Stiffness|||-0.16|-0.62|
71676275|NCT01931475|142870133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|||||TWO_SIDED|95.0|-0.41|-0.15||||||||-0.15|-0.41|
71676276|NCT01931475|142870134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||||TWO_SIDED|95.0|-1.07|-0.34|||||BPI Severity of Worst Pain|||-0.34|-1.07|
71809602|NCT00677833|143120899|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.74|||||TWO_SIDED|95.0|-12.15|-1.32|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-1.32|-12.15|
71843773|NCT03500549|143201313|OTHER|Non-inferiority was not assessed because of the prespecified hierarchical testing. Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.87||||0.0005|TWO_SIDED|95.0|5.49|18.25||MRMM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||18.25|5.49|0.0005
71676277|NCT01931475|142870134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-0.6|0.03|||||BPI Severity of Least Pain|||0.03|-0.60|
71809603|NCT00677833|143120899|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.78|||||TWO_SIDED|95.0|-12.82|-0.75|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-0.75|-12.82|
71809604|NCT00677833|143120899|SUPERIORITY_OR_OTHER||ACPR percent difference|-6.92|||||TWO_SIDED|95.0|-14.59|0.76|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||0.76|-14.59|
71809605|NCT00677833|143120899|SUPERIORITY_OR_OTHER||ACPR percent difference|-8.63|||||TWO_SIDED|95.0|-17.08|-0.18|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-0.18|-17.08|
71676278|NCT01931475|142870134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||BPI Severity of Right Now Pain|||-0.11|-0.82|
71676279|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.53|-0.02|||||BPI Interference Average Score|||-0.02|-0.53|
71676280|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-0.94|-0.19|||||General activity|||-0.19|-0.94|
71676281|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-0.74|-0.05|||||Mood|||-0.05|-0.74|
71676282|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-0.82|-0.11|||||Walking ability|||-0.11|-0.82|
71676283|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.31|||||TWO_SIDED|95.0|-0.68|0.06|||||Normal work (includes both work outside the home and housework)|||0.06|-0.68|
71676284|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||||TWO_SIDED|95.0|-0.34|0.21|||||Relations with other people|||0.21|-0.34|
71676285|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.57|0.14|||||Sleep|||0.14|-0.57|
71676286|NCT01931475|142870135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.4|0.27|||||Enjoyment of life|||0.27|-0.40|
71676287|NCT01931475|142870137|SUPERIORITY_OR_OTHER||Total Effect|97.49||||0.002|TWO_SIDED||||||Regression, Linear|||Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.||||0.002
71676288|NCT02920008|142870149|SUPERIORITY||||||=|0.3287|||||||Stratified log-rank|||||||= 0.3287
71676289|NCT00930774|142870183|SUPERIORITY_OR_OTHER|||||||0.527|||||||ANOVA|df = 3,83; F=0.748||||||0.527
71676290|NCT00930774|142870184|SUPERIORITY_OR_OTHER|||||||0.835|||||||ANOVA|df = 3,83; F=0.286||||||0.835
71676291|NCT00930774|142870185|SUPERIORITY_OR_OTHER|||||||0.983|||||||ANOVA|df = 3,83; F=0.054||||||0.983
71676292|NCT00930774|142870186|SUPERIORITY_OR_OTHER|||||||0.554||||||df = 3,83; F=0.701|ANOVA|||||||0.554
71809606|NCT00677833|143120900|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.63|||||TWO_SIDED|95.0|-8.4|1.14|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||1.14|-8.40|
71843774|NCT03500549|143201314|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6745|||||TWO_SIDED|95.0|0.5452|0.8039|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.8039|0.5452|
71843775|NCT03500549|143201315|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.6639|||||TWO_SIDED|95.0|0.5309|0.7968|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.7968|0.5309|
71809607|NCT00677833|143120900|SUPERIORITY_OR_OTHER||ACPR percent difference|-3.87|||||TWO_SIDED|95.0|-10.79|3.04|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||3.04|-10.79|
71809608|NCT00677833|143120900|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.66|||||TWO_SIDED|95.0|-13.55|2.22|||Kaplan-Meier, curves|||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||2.22|-13.55|
71809609|NCT00677833|143120901|SUPERIORITY_OR_OTHER||ACPR percent difference|-5.04|||||TWO_SIDED|95.0|-9.93|-0.15|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.||-0.15|-9.93|
71809610|NCT00677833|143120901|SUPERIORITY_OR_OTHER||ACPR percent difference|-7.71|||||TWO_SIDED|95.0|-14.54|-0.88|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||-0.88|-14.54|
71809611|NCT00677833|143120901|SUPERIORITY_OR_OTHER||ACPR percent difference|-15.09|||||TWO_SIDED|95.0|-26.24|-3.94|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-3.94|-26.24|
71809612|NCT00677833|143120901|SUPERIORITY_OR_OTHER||ACPR percent difference|-21.76|||||TWO_SIDED|95.0|-34.14|-9.39|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-9.39|-34.14|
71809613|NCT00677833|143120901|SUPERIORITY_OR_OTHER||ACPR percent difference|-18.24|||||TWO_SIDED|95.0|-31.05|-5.43|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-5.43|-31.05|
71809614|NCT00677833|143120901|SUPERIORITY_OR_OTHER||ACPR Percent difference|-18.49|||||TWO_SIDED|95.0|-31.33|-5.65|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.||-5.65|-31.33|
71809615|NCT00677833|143120902|SUPERIORITY_OR_OTHER||ACPR percent difference|-4.67|||||TWO_SIDED|95.0|-10.6|1.25|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.||1.25|-10.60|
71809616|NCT00677833|143120902|SUPERIORITY_OR_OTHER||ACPR percent difference|-13.07|||||TWO_SIDED|95.0|-24.21|-1.92|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.||-1.92|-24.21|
71809617|NCT00677833|143120902|SUPERIORITY_OR_OTHER||ACPR percent difference|-19.62|||||TWO_SIDED|95.0|-32.16|-7.08|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.||-7.08|-32.16|
71676293|NCT00930774|142870187|SUPERIORITY_OR_OTHER|||||||0.757||||||df = 3,83; F=0.395|ANOVA|||||||0.757
71676294|NCT00930774|142870188|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANOVA|df = 3,83; F=1.236||||||0.302
71676295|NCT00930774|142870189|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|df = 3,83. F=6.343||||||0.001
71676296|NCT00930774|142870189|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71809618|NCT00677833|143120902|SUPERIORITY_OR_OTHER||ACPR percent difference|-16.38|||||TWO_SIDED|95.0|-29.42|-3.33|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)-(AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.||-3.33|-29.42|
71809619|NCT00677833|143120902|SUPERIORITY_OR_OTHER||ACPR Percent difference|-16.94|||||TWO_SIDED|95.0|-30.04|-3.83|||Kaplan-Meier curves|||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions \[(AZ-CQ)- (AL)\] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.||-3.83|-30.04|
71809620|NCT00677833|143120909|SUPERIORITY_OR_OTHER||percent difference|-5.89|||||TWO_SIDED|95.0|-11.02|-0.75|||large sample approximation to binomial|||Day 7||-0.75|-11.02|
71809621|NCT00677833|143120909|SUPERIORITY_OR_OTHER||percent difference|-7.55|||||TWO_SIDED|95.0|-13.14|-1.95|||large sample approximation to binomial|||Day 14||-1.95|-13.14|
71809622|NCT00677833|143120909|SUPERIORITY_OR_OTHER||percent difference|-7.6|||||TWO_SIDED|95.0|-13.61|-1.6|||large sample approximation to binomial|||Day 21||-1.60|-13.61|
71809623|NCT00677833|143120909|SUPERIORITY_OR_OTHER||percent difference|-9.26|||||TWO_SIDED|95.0|-15.64|-2.87|||Large sample approximation to binomial|||Day 28||-2.87|-15.64|
71809624|NCT00677833|143120909|SUPERIORITY_OR_OTHER||percent difference|-7.71|||||TWO_SIDED|95.0|-14.45|-0.97|||Large sample approximation to binomial|||Day 35||-0.97|-14.45|
71809625|NCT00677833|143120909|SUPERIORITY_OR_OTHER||percent difference|-8.52|||||TWO_SIDED|95.0|-15.43|-1.6|||Large sample approximation to binomial|||Day 42||-1.60|-15.43|
71809626|NCT00677833|143120910|SUPERIORITY_OR_OTHER||percent difference|-9.51|||||TWO_SIDED|95.0|-18.27|-0.74|||Large sample approximation to binomial|||Day 7||-0.74|-18.27|
71809627|NCT00677833|143120910|SUPERIORITY_OR_OTHER||percent difference|-10.39|||||TWO_SIDED|95.0|-19.23|-1.55|||Large sample approximation to binomial|||Day 14||-1.55|-19.23|
71809628|NCT00677833|143120910|SUPERIORITY_OR_OTHER||percent difference|-12.75|||||TWO_SIDED|95.0|-21.45|-4.04|||Large sample approximation to binomial|||Day 21||-4.04|-21.45|
71809629|NCT00677833|143120910|SUPERIORITY_OR_OTHER||percent difference|-11.11|||||TWO_SIDED|95.0|-19.62|-2.6|||Large sample approximation to binomial|||Day 28||-2.60|-19.62|
71809630|NCT00677833|143120910|SUPERIORITY_OR_OTHER||percent difference|-10.34|||||TWO_SIDED|95.0|-18.97|-1.71|||Large sample approximation to binomial|||Day 35||-1.71|-18.97|
71809631|NCT00677833|143120910|SUPERIORITY_OR_OTHER||percent difference|-11.21|||||TWO_SIDED|95.0|-20.14|-2.28|||Large sample approximation to binomial|||Day 42||-2.28|-20.14|
71809632|NCT00677833|143120911|SUPERIORITY_OR_OTHER|||||||0.2564|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.2564
71809633|NCT00677833|143120912|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||<0.0001
71809634|NCT00677833|143120915|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.||||0.0006
71809635|NCT05072457|143120918|OTHER||||||<|0.05|||||||ANOVA|||"MANOVA analysis with independent variable being the intervention condition (type of microphone used) and dependent variable being the performance on lateralization task.~Null hypothesis: There will be no statistically significant difference in lateralization test scores between the Roger On and the Roger Select in the experimental group."||||<.05
71809636|NCT05072457|143120919|OTHER||||||>|0.05|||||||ANOVA|||Independent variable: intervention condition (type of microphone used), Dependent variable: performance on spatial hearing task. Null hypothesis: There will be no statistically significant difference in spatial hearing test scores between the Roger On and the Roger Select in the experimental group.||||>.05
71809637|NCT00184548|143120920|SUPERIORITY_OR_OTHER|||||||0.934||||||Two-sided significance level 5%|Regression, Logistic|||Test for Odds ratio=1, corresponding to a null hypothesis of no difference in mortality for patients who died between groups for Blunt Trauma. Odds-ratio is adjusted for baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury (P/F \> 200). Missing covariates are imputed by the mean value.||||0.934
71809638|NCT00184548|143120920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.589||95.0|0.64|2.17||Two-sided significance level 5%|Cox Proportional Hazards Model|||Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma -Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury.||2.17|0.64|0.589
71809639|NCT00184548|143120922|SUPERIORITY_OR_OTHER||LS means|0.9||||0.308||95.0|-0.83|2.63|||ANCOVA|||Baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma -Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury.||2.63|-0.83|0.308
71809640|NCT00184548|143120924|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|1.0||||0.038||95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|0.038
71809641|NCT00184548|143120925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.175||||0.384||95.0|0.817|1.69|||Regression, Logistic|||||1.690|0.817|0.384
71809642|NCT00184548|143120926|SUPERIORITY_OR_OTHER||Hodges-Lehmann shift estimate|2.0||||0.03||95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)|||||4|0|0.030
71809643|NCT02184611|143120948|OTHER||Least square mean difference|0.154|||<|0.001|TWO_SIDED|95.0|0.113|0.194||Analysis was performed using a MMRM model with covariates of treatment, Baseline, smoking status, country, Day, Day by Baseline and Day by treatment interactions.|Mixed Models Repeated Measures (MMRM)|||UMEC versus Placebo.||0.194|0.113|<0.001
71809644|NCT02184611|143120949|OTHER||Least square Mean difference|0.9||||0.004|TWO_SIDED|95.0|0.3|1.5||Analysis performed using a MMRM model with covariates of treatment, BDI focal score, smoking status, country, Day, Day by BDI focal score and Day by treatment interactions.|MMRM|||UMEC versus Placebo.||1.5|0.3|0.004
71809645|NCT02184611|143120950|OTHER||Least square Mean difference|0.125|||<|0.001|TWO_SIDED|95.0|0.103|0.147||Analysis performed using an analysis of covariance (ANCOVA) model with covariates of treatment, baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status and country.|ANCOVA|||UMEC versus Placebo.||0.147|0.103|<0.001
71843776|NCT03500549|143201316|OTHER|Stratified CMH chi-square test was used for treatment comparison and the 95% CI for difference in percentage between treatments is constructed using the stratified Miettinen-Nurminen method.|Difference in percentage|0.3043|||||TWO_SIDED|95.0|0.1493|0.4593|||||The difference in percentage and 95% CI is calculated based on stratified Miettinen-Nurminen method stratified by randomization factor so it it is not a direct difference of two reporting groups.|||0.4593|0.1493|
71843777|NCT03500549|143201317|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-21.93||||0.0002|TWO_SIDED|95.0|-32.49|-11.36||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-11.36|-32.49|0.0002
71843778|NCT03500549|143201318|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.14||||0.0369|TWO_SIDED|95.0|-0.28|-0.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||-0.01|-0.28|0.0369
71843779|NCT03500549|143201319|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|59.1||||0.0069|TWO_SIDED|95.0|16.88|101.32||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||||101.32|16.88|0.0069
71843780|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|18.62||||0.0486|TWO_SIDED|95.0|0.12|37.13||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Global Health Status/QoL: Difference in LS mean||37.13|0.12|0.0486
71843781|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|12.86||||0.0023|TWO_SIDED|95.0|4.86|20.86||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Physical functioning: Difference in LS mean||20.86|4.86|0.0023
71843782|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|24.43||||0.0027|TWO_SIDED|95.0|8.84|40.01||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Role functioning: Difference in LS mean||40.01|8.84|0.0027
71843783|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|4.11||||0.6013|TWO_SIDED|95.0|-11.58|19.8||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Emotional functioning: Difference in LS mean||19.80|-11.58|0.6013
71843784|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|9.56||||0.1792|TWO_SIDED|95.0|-4.52|23.64||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Cognitive functioning: Difference in LS mean||23.64|-4.52|0.1792
71843785|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|11.27||||0.1039|TWO_SIDED|95.0|-2.38|24.92||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Functional Scales - Social functioning: Difference in LS mean||24.92|-2.38|0.1039
71843786|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-20.74||||0.0062|TWO_SIDED|95.0|-35.29|-6.19||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Fatigue: Difference in LS mean||-6.19|-35.29|0.0062
71843787|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-0.01||||0.9975|TWO_SIDED|95.0|-8.38|8.35||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Nausea and vomiting: Difference in LS mean||8.35|-8.38|0.9975
71676297|NCT00930774|142870190|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANOVA|df = 3,83; F=3.797||||||0.013
71809646|NCT02184611|143120959|OTHER||Least sqaure mean difference|-4.39||||0.002|TWO_SIDED|95.0|-7.21|-1.58||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-1.58|-7.21|0.002
71843788|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-2.76||||0.7554|TWO_SIDED|95.0|-20.36|14.85||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Pain: Difference in LS mean||14.85|-20.36|0.7554
71843789|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-14.57||||0.062|TWO_SIDED|95.0|-29.9|0.76||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Dyspnoea: Difference in LS mean||0.76|-29.90|0.0620
71843790|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|0.32||||0.9686|TWO_SIDED|95.0|-15.67|16.3||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Insomnia: Difference in LS mean||16.30|-15.67|0.9686
71843791|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.95||||0.3002|TWO_SIDED|95.0|-23.23|7.33||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Appetite loss: Difference in LS mean||7.33|-23.23|0.3002
71843792|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|1.79||||0.8374|TWO_SIDED|95.0|-15.7|19.29||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Constipation: Difference in LS mean||19.29|-15.70|0.8374
71843793|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-1.38||||0.8775|TWO_SIDED|95.0|-19.28|16.52||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Diarrhoea: Difference in LS mean||16.52|-19.28|0.8775
71809647|NCT02184611|143120959|OTHER||Least square mean difference|-4.59||||0.003|TWO_SIDED|95.0|-7.61|-1.57||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-1.57|-7.61|0.003
71809648|NCT02184611|143120959|OTHER||Least sqaure mean difference|-3.03||||0.058|TWO_SIDED|95.0|-6.15|0.1||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 168, UMEC Vs Placebo.||0.10|-6.15|0.058
71843794|NCT03500549|143201320|OTHER|Analysis was a between-treatment-group comparison using an MMRM. The difference between pegcetacoplan and eculizumab LS mean changes from Baseline at Week 16 was calculated along with its 2-sided 95% CI and associated P-value from the MMRM model for the ITT set, censored for transfusions.|LS mean difference|-7.4||||0.3066|TWO_SIDED|95.0|-21.76|6.95||MMRM includes treatment + baseline value + analysis visit + strata + analysis visit × treatment, where strata is the combination of randomization stratification factors.|MMRM|||Symptom Scales - Financial difficulties: Difference in LS mean||6.95|-21.76|0.3066
71895303|NCT00847613|143312933|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|5.61||||0.0034|TWO_SIDED|95.0|1.85|9.38||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||9.38|1.85|0.0034
71676298|NCT00930774|142870190|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71676299|NCT03200704|142870191|NON_INFERIORITY|90% power, 2.5% one-sided significance level,5% non-inferiority margin|||||<|0.0001|||||||Regression, Logistic|||"Hypothesis:~H0: QT ≤ QC - 0.05 H1: QT \> QC - 0.05"||||<0.0001
71676300|NCT02217410|142870198|OTHER||Mean Difference (Final Values)|0.095||||0.8976|TWO_SIDED|95.0|-0.067|0.263|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 3|||0.263|-0.067|0.8976
71676301|NCT02217410|142870198|OTHER||Mean Difference (Final Values)|0.093||||0.8836|TWO_SIDED|95.0|-0.084|0.271|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 6|||0.271|-0.084|0.8836
71676302|NCT02217410|142870198|OTHER||Mean Difference (Final Values)|0.093||||0.8822|TWO_SIDED|95.0|-0.085|0.272|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 9|||0.272|-0.085|0.8822
71843795|NCT03500549|143201321|OTHER|Wilcoxon rank-sum test P-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% CI is constructed using Hodges-Lehmann Estimation of Location Shift.|Median Difference (Final Values)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0|||Wilcoxon rank-sum test|||||4.0|2.0|<0.0001
71843796|NCT01371994|143201373|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1745|TWO_SIDED||||||Log Rank|Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and \> 3).||The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and \>3) at a 2-sided significance level of 0.05.||||0.1745
71895304|NCT00754390|143312996|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption||||0.17
71895305|NCT00754390|143312996|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption||||0.0002
71895306|NCT00754390|143312996|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.||||0.09
71895307|NCT03443024|143313045|SUPERIORITY|||||||0.0165|||||||ANCOVA|||||||0.0165
71895308|NCT03443024|143313045|SUPERIORITY|||||||0.0022|TWO_SIDED|95.0|||||ANCOVA|||||||0.0022
71895309|NCT03443024|143313045|SUPERIORITY|||||||0.0005|TWO_SIDED|95.0|||||ANCOVA|||||||0.0005
71895310|NCT03443024|143313046|SUPERIORITY|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
71895311|NCT03443024|143313046|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
71895312|NCT03443024|143313046|SUPERIORITY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||||||0.0005
71895313|NCT03443024|143313047|SUPERIORITY|||||||0.1917|||||||Cochran-Mantel-Haenszel|||||||0.1917
71895314|NCT03443024|143313047|SUPERIORITY|||||||0.0392|||||||Cochran-Mantel-Haenszel|||||||0.0392
71895315|NCT03443024|143313047|SUPERIORITY|||||||0.0023|||||||Cochran-Mantel-Haenszel|||||||0.0023
71895316|NCT03443024|143313048|SUPERIORITY|||||||0.2043|||||||Cochran-Mantel-Haenszel|||||||0.2043
71895317|NCT03443024|143313048|SUPERIORITY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||||||0.0021
71843797|NCT01371994|143201374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4833|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 4||||0.4833
71895318|NCT03443024|143313048|SUPERIORITY|||||||0.0018|||||||Cochran-Mantel-Haenszel|||||||0.0018
71895319|NCT03443024|143313049|SUPERIORITY|||||||0.0554|||||||Cochran-Mantel-Haenszel|||||||0.0554
71895320|NCT03443024|143313049|SUPERIORITY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||||||0.0037
71895321|NCT03443024|143313049|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
71895322|NCT03443024|143313050|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|||||||0.0800
71895323|NCT03443024|143313050|SUPERIORITY|||||||0.0062|||||||Cochran-Mantel-Haenszel|||||||0.0062
71895324|NCT03443024|143313050|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
71895325|NCT03443024|143313051|SUPERIORITY|||||||0.0773|||||||ANCOVA|||||||0.0773
71895326|NCT03443024|143313051|SUPERIORITY|||||||0.0459|||||||ANCOVA|||||||0.0459
71895327|NCT03443024|143313051|SUPERIORITY|||||||0.0062|TWO_SIDED|95.0|||||ANCOVA|||||||0.0062
71895328|NCT03443024|143313052|SUPERIORITY|||||||0.0047|||||||ANCOVA|||||||0.0047
71895329|NCT03443024|143313052|SUPERIORITY|||||||0.0002|TWO_SIDED|95.0|||||ANCOVA|||||||0.0002
71895330|NCT03443024|143313052|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71895331|NCT03443024|143313053|SUPERIORITY|||||||0.6674|||||||Cochran-Mantel-Haenszel|||||||0.6674
71676303|NCT02217410|142870198|OTHER||Mean Difference (Final Values)|0.093||||0.8821|TWO_SIDED|95.0|-0.087|0.273|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is \< 20%.|Month 12|||0.273|-0.087|0.8821
71843798|NCT01371994|143201374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5761|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 8||||0.5761
71843799|NCT01371994|143201374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0592|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 12||||0.0592
71843800|NCT01371994|143201374|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison of end of treatment analysis||||0.0390
71895332|NCT03443024|143313053|SUPERIORITY|||||||0.1166|||||||Cochran-Mantel-Haenszel|||||||0.1166
71895333|NCT03443024|143313053|SUPERIORITY|||||||0.0119|||||||Cochran-Mantel-Haenszel|||||||0.0119
71895334|NCT03443024|143313054|SUPERIORITY|||||||0.2371|||||||Cochran-Mantel-Haenszel|||||||0.2371
71895335|NCT03443024|143313054|SUPERIORITY|||||||0.1067|||||||Cochran-Mantel-Haenszel|||||||0.1067
71895336|NCT03443024|143313054|SUPERIORITY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||||||0.0008
71895337|NCT03443024|143313055|SUPERIORITY|||||||0.4631|||||||ANCOVA|||||||0.4631
71895338|NCT03443024|143313055|SUPERIORITY|||||||0.0368|||||||ANCOVA|||||||0.0368
71895339|NCT03443024|143313055|SUPERIORITY|||||||0.0232|||||||ANCOVA|||||||0.0232
71895340|NCT03443024|143313056|SUPERIORITY|||||||0.4729|||||||ANCOVA|||||||0.4729
71895341|NCT03443024|143313056|SUPERIORITY|||||||0.0282|||||||ANCOVA|||||||0.0282
71895342|NCT03443024|143313056|SUPERIORITY|||||||0.0506|||||||ANCOVA|||||||0.0506
71895343|NCT01933672|143313081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.24|||||TWO_SIDED|80.0|-36.35|-26.12||||||Change from baseline||-26.12|-36.35|
71895344|NCT01933672|143313081|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-31.33|||||TWO_SIDED|80.0|-37.29|-25.37||||||Change from baseline||-25.37|-37.29|
71895345|NCT01933672|143313081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.24|||||TWO_SIDED|80.0|-24.99|-13.5||||||Change from baseline||-13.50|-24.99|
71895346|NCT01933672|143313081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
71843801|NCT01371994|143201376|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3604|TWO_SIDED|95.0|-0.14|0.38|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 4||0.38|-0.14|0.3604
71676304|NCT00839527|142870207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.68|||ANCOVA|||||-0.68|-1.07|<0.0001
71676305|NCT00839527|142870207|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Mean Difference (Net)|0.25||||0.2685|TWO_SIDED|95.0|0.1|0.4|||t-test, 1 sided|||||0.40|0.10|0.2685
71676306|NCT01704651|142870216|SUPERIORITY_OR_OTHER|||||||0.34|||||||t-test, 2 sided|||||||0.34
71676307|NCT01704651|142870217|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71676308|NCT00778869|142870224|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student t-test|||||||<0.05
71843802|NCT01371994|143201376|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0761|TWO_SIDED|95.0|-0.03|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 8||0.52|-0.03|0.0761
71843803|NCT01371994|143201376|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0149|TWO_SIDED|95.0|0.07|0.64|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 12||0.64|0.07|0.0149
71843804|NCT01371994|143201376|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0325|TWO_SIDED|95.0|0.02|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison of end of treatment analysis||0.52|0.02|0.0325
71843805|NCT01371994|143201378|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.46||0.5186|TWO_SIDED|95.0|-0.6|1.19|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.19|-0.60|0.5186
71843806|NCT01371994|143201378|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.3|STANDARD_ERROR_OF_MEAN|0.43||0.4521|TWO_SIDED|95.0|-0.52|1.17|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.17|-0.52|0.4521
71843807|NCT01371994|143201380|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1493|TWO_SIDED|95.0|-0.07|0.47|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||0.47|-0.07|0.1493
71843808|NCT01371994|143201380|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1499|TWO_SIDED|95.0|-0.07|0.44|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||0.44|-0.07|0.1499
71843809|NCT01371994|143201382|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.5|STANDARD_ERROR_OF_MEAN|0.35||0.1279|TWO_SIDED|95.0|-0.16|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||1.23|-0.16|0.1279
71676309|NCT01218087|142870261|NON_INFERIORITY_OR_EQUIVALENCE|Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.||||||0.03|TWO_SIDED||||||Fisher Exact|||||||0.03
71843810|NCT01371994|143201382|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.6|STANDARD_ERROR_OF_MEAN|0.34||0.1038|TWO_SIDED|95.0|-0.11|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||1.23|-0.11|0.1038
71843811|NCT01371994|143201384|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.98||0.8876|TWO_SIDED|95.0|-4.19|3.63|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||3.63|-4.19|0.8876
71843812|NCT01371994|143201384|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|STANDARD_ERROR_OF_MEAN|2.86||0.395|TWO_SIDED|95.0|-8.1|3.21|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||3.21|-8.10|0.3950
71843813|NCT01371994|143201386|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.43||0.4126|TWO_SIDED|95.0|-2.82|6.81|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.81|-2.82|0.4126
71843814|NCT01371994|143201386|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.0|STANDARD_ERROR_OF_MEAN|2.47||0.6959|TWO_SIDED|95.0|-3.92|5.85|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.85|-3.92|0.6959
71843815|NCT01371994|143201388|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|3.3|STANDARD_ERROR_OF_MEAN|2.81||0.2402|TWO_SIDED|95.0|-2.26|8.91|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||8.91|-2.26|0.2402
71843816|NCT01371994|143201388|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.1|STANDARD_ERROR_OF_MEAN|2.83||0.698|TWO_SIDED|95.0|-4.5|6.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||6.70|-4.50|0.6980
71843817|NCT01371994|143201390|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|2.0|STANDARD_ERROR_OF_MEAN|2.46||0.4067|TWO_SIDED|95.0|-2.8|6.89|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12||6.89|-2.80|0.4067
71843818|NCT01371994|143201390|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.4|STANDARD_ERROR_OF_MEAN|2.36||0.8507|TWO_SIDED|95.0|-4.21|5.1|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis||5.10|-4.21|0.8507
71676310|NCT04463251|142870321|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
71676311|NCT04463251|142870321|OTHER||Least square means ratio|0.58|||||TWO_SIDED|95.0|0.37|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.37|
71676312|NCT04463251|142870322|OTHER||Least square means ratio|0.54|||||TWO_SIDED|95.0|0.34|0.87|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.87|0.34|
71676313|NCT04463251|142870322|OTHER||Least square means ratio|0.6|||||TWO_SIDED|95.0|0.37|0.95|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.95|0.37|
71676314|NCT04463251|142870323|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
71676315|NCT04463251|142870323|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
71676316|NCT04463251|142870324|OTHER||Least square means ratio|0.56|||||TWO_SIDED|95.0|0.34|0.91|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation"|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.91|0.34|
71809649|NCT02184611|143120960|OTHER||Least sqaure mean difference|-1.49||||0.027|TWO_SIDED|95.0|-2.81|-0.17||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.||-0.17|-2.81|0.027
71809650|NCT02184611|143120960|OTHER||Least square mean difference|-2.1||||0.004|TWO_SIDED|95.0|-3.51|-0.68||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.||-0.68|-3.51|0.004
71809651|NCT02184611|143120960|OTHER||Least square mean difference|-0.68||||0.386|TWO_SIDED|95.0|-2.22|0.86||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 128, UMEC Vs Placebo.||0.86|-2.22|0.386
71809652|NCT02623322|143120998|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
71809653|NCT02623322|143120998|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
71843819|NCT01371994|143201391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center.||||||0.2700
71843820|NCT03593356|143201392|SUPERIORITY||Slope|-0.427|STANDARD_ERROR_OF_MEAN|1.179||0.717|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.717
71843821|NCT03593356|143201395|SUPERIORITY||Slope|-0.012|STANDARD_ERROR_OF_MEAN|0.043||0.784|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.789.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.784
71843822|NCT03593356|143201396|SUPERIORITY||Slope|0.578|STANDARD_ERROR_OF_MEAN|0.807||0.474|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.474
71843823|NCT03593356|143201403|SUPERIORITY||Slope|0.234|STANDARD_ERROR_OF_MEAN|0.882||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.791.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
71809654|NCT02623322|143120999|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3031|TWO_SIDED|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel|||||6.19|-12.25|0.3031
71843824|NCT03593356|143201404|SUPERIORITY||Slope|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.871|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.646.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.871
71843825|NCT03593356|143201405|SUPERIORITY||Slope|0.139|STANDARD_ERROR_OF_MEAN|0.86||0.872|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.872
71843826|NCT03593356|143201408|SUPERIORITY||Slope|0.133|STANDARD_ERROR_OF_MEAN|0.1||0.184|TWO_SIDED|||||We use OLS regression with site fixed effects and baseline covariates. We report unadjusted p-values.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.184
71843827|NCT03593356|143201411|SUPERIORITY||Slope|0.138|STANDARD_ERROR_OF_MEAN|0.173||0.415|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.427.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.415
71843828|NCT03593356|143201412|SUPERIORITY||Slope|0.086|STANDARD_ERROR_OF_MEAN|0.14||0.567|TWO_SIDED|||||We reported the Westfall-Young adjusted p-value, using OLS regression with site fixed effects and baseline covariates. The unadjusted p-value was 0.541.|Regression, Linear||Positive (negative) estimates indicate the high cash gift group had a higher (lower) mean than the low cash gift group. Our measure of dispersion of parameter estimates is the standard error of estimate as described in our analysis plan.|||||0.567
71895347|NCT01933672|143313081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.09|||||TWO_SIDED|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.||-4.17|-19.81|
71895348|NCT01933672|143313082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.92|||||TWO_SIDED|80.0|-27.0|-16.85||||||Compared with Baseline||-16.85|-27.00|
71809655|NCT02623322|143120999|SUPERIORITY||Difference in event rates (Wald)|-3.03||||0.3324|TWO_SIDED|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel|||||6.76|-12.82|0.3324
71809656|NCT02623322|143121003|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.7858|TWO_SIDED|80.0|0.62|1.37|||Wilcoxon|||Total Symptom Score of \<=1||1.37|0.62|0.7858
71809657|NCT02623322|143121003|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.517|TWO_SIDED|80.0|0.59|1.36|||Wilcoxon|||Total Symptom Score of \<=1||1.36|0.59|0.5170
71843829|NCT03777657|143201655|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0056|TWO_SIDED|95.0|0.59|0.94||The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.|One-sided Log Rank Test|One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.94|0.59|0.0056
71895349|NCT01933672|143313082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|||||TWO_SIDED|80.0|-26.3|-15.1||||||Compared with Baseline||-15.10|-26.30|
71895350|NCT01933672|143313082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.51|||||TWO_SIDED|80.0|-22.24|-10.78||||||Compared with Baseline||-10.78|-22.24|
71809658|NCT02623322|143121003|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0312|TWO_SIDED|80.0|0.45|0.89|||Wilcoxon|||Total Symptom Score of \<=7||0.89|0.45|0.0312
71809659|NCT02623322|143121003|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.2044|TWO_SIDED|80.0|0.53|1.04|||Wilcoxon|||Total Symptom Score of \<=7||1.04|0.53|0.2044
71809660|NCT03563716|143121005|SUPERIORITY||Odds Ratio (OR)|2.57|||||TWO_SIDED|95.0|1.07|6.14|||||95% CI for odds ratio was constructed using the Wald method.|Stratified analysis based on PD-L1 immunohistochemistry (IHC) 22C3 pharmDx, tumor histology status, and tobacco history.||6.14|1.07|
71809661|NCT03563716|143121006|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.37|0.9|||||Hazard ratios were estimated by Cox regression.|Stratified analysis based on PD-L1 IHC 22C3 pharmDx, tumor histology status, and tobacco history.||0.90|0.37|
71895351|NCT01933672|143313082|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.41|||||TWO_SIDED|80.0|-11.74|0.92||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||0.92|-11.74|
71676317|NCT04463251|142870324|OTHER||Least square means ratio|0.61|||||TWO_SIDED|95.0|0.38|0.98|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~* Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is equal to 1.~* Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-14) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-14) in the placebo group is different from 1."||0.98|0.38|
71676318|NCT04463251|142870325|OTHER||Least square means ratio|0.52|||||TWO_SIDED|95.0|0.34|0.81||||||"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."|"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|0.81|0.34|
71676319|NCT04463251|142870325|OTHER||Least square means ratio|0.48|||||TWO_SIDED|95.0|0.31|0.74|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.74|0.31|
71676320|NCT04463251|142870326|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.29|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 80 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.29|
71809662|NCT03775200|143121013|OTHER|For this primary analysis, a sample size of 216 randomised participants (72:72:72) will provide 90% power at the alpha = 0.05 level to detect a 6-point difference in average MADRS total score between the optimal therapeutic dose of COMP360 and COMP360 1 mg, assuming the common standard deviation (SD) is 11.0.|Least Mean Square Difference|-6.6|STANDARD_ERROR_OF_MEAN|1.86|<|0.05|TWO_SIDED|95.0|-10.2|-2.9|||Mixed Models Analysis|Hypothetical strategy estimand - missing not at random (MNAR) and missing at random (MAR) imputation for missing data.|LSM difference of COMP360 25 mg compared to COMP360 1 mg.|The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.||-2.9|-10.2|<0.05
71809663|NCT03775200|143121014|OTHER||Least Mean Square Difference|-5.6|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|95.0|-9.4|-1.8|||Mixed Models Analysis|Hypothetical strategy estimand - MNAR and MAR imputation for missing data.||Sensitivity analysis of the primary endpoint using the per-protocol analysis set.||-1.8|-9.4|<0.05
71809664|NCT04605978|143121015|SUPERIORITY||Mean Difference (Net)|2.44|||||TWO_SIDED|95.0|-0.61|5.49|||||Missing data and data post intercurrent event were imputed for the statistical analysis as specified in the statistical analysis plan.|||5.49|-0.61|
71809665|NCT03813238|143121023|SUPERIORITY||LS mean difference|-1.2||||0.335|TWO_SIDED|95.0|-3.49|1.19|||Mixed Models Analysis|||The LS mean of the change in MDCRS part II total score from baseline to Week 15 was compared (TEV-50717 arm versus placebo) using a 1-sided test for superiority at a nominal significance level of α=0.025.||1.19|-3.49|0.335
71809666|NCT03318523|143121060|SUPERIORITY|Adjusted mean, difference with placebo, 95% confidence interval (CI), and p-value were based on a mixed model for repeated measures (MMRM) model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.3||||0.8976|TWO_SIDED|95.0|-4.888|4.287|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.287|-4.888|0.8976
71809667|NCT03318523|143121060|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.5||||0.796|TWO_SIDED|95.0|-3.31|4.312|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||4.312|-3.310|0.7960
71843830|NCT03777657|143201656|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0011|TWO_SIDED|95.0|0.7|0.92||The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.|One-Sided Log-Rank Test|One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.|The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.92|0.70|0.0011
71676321|NCT04463251|142870326|OTHER||Least square means ratio|0.47|||||TWO_SIDED|95.0|0.3|0.75|||||"Least square means ratio with two-sided Dunnett's adjusted 95% CI for RPH-104 160 mg / Placebo.~Ratio was calculated instead of difference because log data transformation."|"The following (two-sided) hypotheses were tested:~Null hypothesis H0: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is equal to 1.~Alternative hypothesis H1: the ratio of the geometric mean of hsCRP-AUC(days 1-28) in RPH-104 group to the geometric mean of hsCRP-AUC(days 1-28) in the placebo group is different from 1."||0.75|0.30|
71676322|NCT03689374|142870367|NON_INFERIORITY|The responses were analyzed using an ANCOVA with treatment as fixed factor and baseline value as a covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomized treatment, using a regression model including randomized treatment group and data from baseline and all previous visits as covariates. The prespecified non inferiority margin was 0.3%-point.|Treatment difference|-0.29|||<|0.0001|TWO_SIDED|95.0|-0.38|-0.2|||t-distributed test|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test.||||-0.20|-0.38|<0.0001
71676323|NCT02282631|142870409|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|"U=390.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."||||||0.02
71676324|NCT02282631|142870410|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=665.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
71676325|NCT02282631|142870411|SUPERIORITY_OR_OTHER|||||||0.02||||||"U=596.5 Z=-2.4 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.02
71676326|NCT02282631|142870412|SUPERIORITY_OR_OTHER|||||||0.01||||||"U=955.0 Z=-2.5 p=0.01~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)|||||||0.01
71676327|NCT06175026|142870460|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.13|1.37||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health messages would not elicit different levels of perceived message effectiveness compared to the neutral messages.||1.37|1.13|<0.001
71676328|NCT06175026|142870460|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.03|1.26||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the environment messages would not elicit different perceived message effectiveness than the control messages.||1.26|1.03|<.001
71676329|NCT06175026|142870460|SUPERIORITY||Mean Difference (Final Values)|1.29|STANDARD_ERROR_OF_MEAN|0.062|<|0.001|TWO_SIDED|95.0|1.17|1.41||The p-value was not adjusted for multiple comparisons. The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|||The null hypothesis was that the health and environment messages would not elicit different perceived message effectiveness than the control messages.||1.41|1.17|<0.001
71809668|NCT03318523|143121060|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.08||||0.9695|TWO_SIDED|95.0|-3.805|3.956|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 52||3.956|-3.805|0.9695
71843831|NCT03777657|143201657|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.56|0.83|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region and presence of peritoneal metastasis as strata.|||0.83|0.56|
71843832|NCT03777657|143201658|OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04|||||Odds ratio between arms weas calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis.|||2.04|1.03|
71676330|NCT06175026|142870460|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.062||0.1892|TWO_SIDED|95.0|-0.018|0.223||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.223|-0.018|.1892
71676331|NCT06175026|142870460|SUPERIORITY||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.62||0.47|TWO_SIDED|95.0|-0.17|0.08||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||.08|-.17|.47
71676332|NCT06175026|142870460|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.051|TWO_SIDED|95.0|-0.27|-0.03||This p-value was adjusted for multiple comparisons (considering 3 tests among intervention arms) using the Bonferroni Holm method.|Mixed Models Analysis|||||-.03|-.27|.051
71676333|NCT04081610|142870461|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through the incidence of AD.|Median Difference (Final Values)|0.05||||0.409|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.409
71676334|NCT04081610|142870462|NON_INFERIORITY|Compare the tolerability of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit-dose manufactured by Sophia Laboratories S.A. of C.V. using the ICO score.||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
71676335|NCT04081610|142870462|EQUIVALENCE|F=2.606, 15.926||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.009
71676336|NCT04081610|142870462|EQUIVALENCE|F=3.051, 19.336||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Final vs initial Eye Comfort Index||||0.002
71676337|NCT04081610|142870463|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. through changes in BCVA.||||||0.904|||||||Wilcoxon (Mann-Whitney)|||||||0.904
71676338|NCT04081610|142870463|EQUIVALENCE|F=-1.414, 1.061||||||0.157|||||||Sign test|||Final vs initial VA||||0.157
71676339|NCT04081610|142870463|EQUIVALENCE|||||||1|||||||Sign test|||Final vs initial VA||||1.000
71676340|NCT04081610|142870464|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in corneal and conjunctival staining with fluorescein.||||||1|||||||Fisher Exact|||||||1.000
71676341|NCT04081610|142870464|EQUIVALENCE|Chi-squared (2)= 6.400||||||0.041|||||||Chi-squared|||Final vs initial fluorescein staining||||0.041
71676342|NCT04081610|142870464|EQUIVALENCE|Chi-squared (2)=0.814||||||0.665|||||||Chi-squared|||||||0.665
71676343|NCT04081610|142870465|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes of corneal and conjunctival staining with lysamine green.||||||0.713|||||||Fisher Exact|||||||0.713
71809669|NCT03318523|143121061|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.28||||0.9093|TWO_SIDED|95.0|-5.035|4.483|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||4.483|-5.035|0.9093
71809670|NCT03318523|143121061|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|1.55||||0.4327|TWO_SIDED|95.0|-2.336|5.44|||Mixed Model for Repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||5.440|-2.336|0.4327
71809671|NCT03318523|143121061|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.17||||0.933|TWO_SIDED|95.0|-4.051|3.719|||Mixed Model with repeated Measures|||Change From Baseline in MDS-UPDRS Total Score at Week 72||3.719|-4.051|0.9330
71676344|NCT04081610|142870465|EQUIVALENCE|Chi-squared (3)=14.345||||||0.002|||||||Chi-squared|||Final vs initial lissamine green staining||||0.002
71676345|NCT04081610|142870465|EQUIVALENCE|Chi-squared (2)=0.506||||||0.777|||||||Chi-squared|||Final vs initial lissamine green staining||||0.777
71676346|NCT04081610|142870466|NON_INFERIORITY|Compare the safety of the Lagricel® Ofteno multi-dose formulation against Lagricel® Ofteno unit doses manufactured by Sophia Laboratories S.A. of C.V. by changes in conjunctival hyperemia.||||||1|||||||Chi-squared, Corrected|||||||1.000
71676347|NCT04081610|142870466|EQUIVALENCE|F=4.167, 1||||||0.031|||||||Fisher Exact|||Final vs initial conjunctival hyperemia||||0.031
71809672|NCT03318523|143121063|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.41||||0.8828|TWO_SIDED|95.0|-5.013|5.825|||Mixed Model for Repeated Measures|||||5.825|-5.013|0.8828
71809673|NCT03318523|143121063|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.84||||0.7019|TWO_SIDED|95.0|-3.458|5.128|||Mixed Model for Repeated Measure|||||5.128|-3.458|0.7019
71809674|NCT03318523|143121063|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.99||||0.6519|TWO_SIDED|95.0|-3.323|5.301|||Mixed Model for Repeated Measures|||||5.301|-3.323|0.6519
71809675|NCT03318523|143121065|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.4327|TWO_SIDED|95.0|-1.851|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||0.794|-1.851|0.4327
71843833|NCT03777657|143201659|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.67|0.9|||||The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.|||0.90|0.67|
71843834|NCT03777657|143201660|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|1.03|1.72|||||Odds ratio between arms were calculated using the Cochran-Mantel-Haenszel method, stratified by regions (Asia versus Europe/North America), PD-L1 expression and presence of peritoneal metastasis.|||1.72|1.03|
71843835|NCT03777657|143201663|OTHER||Least Squares (LS) Mean Difference|1.8|||||TWO_SIDED|95.0|-0.33|3.94|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4||3.94|-0.33|
71676348|NCT04081610|142870466|EQUIVALENCE|No significant change was observed.||||||1|||||||Chi-squared, Corrected|||Final vs initial conjunctival hyperemia||||1.000
71843836|NCT03777657|143201663|OTHER||LS Mean Difference|2.52|||||TWO_SIDED|95.0|0.29|4.74|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||4.74|0.29|
71843837|NCT03777657|143201663|OTHER||LS Mean Difference|1.44|||||TWO_SIDED|95.0|-0.27|3.16||||||Analysis of Change from Baseline in Physical Functioning at Cycle 4||3.16|-0.27|
71843838|NCT03777657|143201663|OTHER||LS Mean Difference|2.46|||||TWO_SIDED|95.0|0.49|4.43|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||4.43|0.49|
71843839|NCT03777657|143201664|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.79|1.15|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 4||1.15|-3.79|
71843840|NCT03777657|143201664|OTHER||LS Mean Difference|-3.01|||||TWO_SIDED|95.0|-5.78|-0.24|||||Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in Fatigue at Cycle 6||-0.24|-5.78|
71843841|NCT03777657|143201665|OTHER||LS Mean Difference|-1.11|||||TWO_SIDED|95.0|-2.53|0.31|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 4||0.31|-2.53|
71843842|NCT03777657|143201665|OTHER||LS Mean Difference|-1.62|||||TWO_SIDED|95.0|-3.12|-0.12|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Index-Score at Cycle 6||-0.12|-3.12|
71843843|NCT03777657|143201665|OTHER||LS Mean Difference|-1.51|||||TWO_SIDED|95.0|-3.13|0.11|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 4||0.11|-3.13|
71843844|NCT03777657|143201665|OTHER||LS Mean Difference|-0.77|||||TWO_SIDED|95.0|-2.31|0.76|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dysphagia/Odynophagia Scale at Cycle 6||0.76|-2.31|
71676349|NCT02225860|142870471|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
71676350|NCT02225860|142870472|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."||||<0.01
71843845|NCT03777657|143201665|OTHER||LS Mean Difference|-2.23|||||TWO_SIDED|95.0|-4.26|-0.2|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 4||-0.20|-4.26|
71843846|NCT03777657|143201665|OTHER||LS Mean Difference|-1.88|||||TWO_SIDED|95.0|-4.03|0.27|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Pain/Discomfort Scale at Cycle 6||0.27|-4.03|
71843847|NCT03777657|143201665|OTHER||LS Mean Difference|-0.93|||||TWO_SIDED|95.0|-2.85|0.99|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 4||0.99|-2.85|
71676351|NCT05338502|142870474|SUPERIORITY||Geometric Least Squares Mean (LSM) Ratio|0.9|||||TWO_SIDED|90.0|0.797|1.02|||ANOVA|||Fasted State||1.02|0.797|
71676352|NCT05338502|142870474|SUPERIORITY||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.876|1.12|||ANOVA|||Fed state||1.12|0.876|
71895352|NCT01933672|143313082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|80.0|-10.86|2.49||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject's period-specific baseline response included, as fixed covariates.||2.49|-10.86|
71676353|NCT05338502|142870475|SUPERIORITY||Geometric LS Mean Ratio|0.932|||||TWO_SIDED|90.0|0.829|1.05|||ANOVA|||Fasted state||1.05|0.829|
71843848|NCT03777657|143201665|OTHER||LS Mean Difference|-1.32|||||TWO_SIDED|95.0|-3.42|0.77|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Dietary Restrictions Scale at Cycle 6||0.77|-3.42|
71843849|NCT03777657|143201665|OTHER||LS Mean Difference|-1.59|||||TWO_SIDED|95.0|-3.28|0.09|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 4||0.09|-3.28|
71895353|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|80.0|-0.19|0.07||||||Compared with Baseline （Pre-breakfast）||0.07|-0.19|
71809676|NCT03318523|143121065|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.13||||0.8155|TWO_SIDED|95.0|-0.965|1.225|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.225|-0.965|0.8155
71809677|NCT03318523|143121065|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.22||||0.7015|TWO_SIDED|95.0|-0.899|1.334|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 52||1.334|-0.899|0.7015
71809678|NCT03318523|143121066|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-1.03||||0.1038|TWO_SIDED|95.0|-2.276|0.213|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||0.213|-2.276|0.1038
71809679|NCT03318523|143121066|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.09||||0.8689|TWO_SIDED|95.0|-0.933|1.103|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.103|-0.933|0.8689
71809680|NCT03318523|143121066|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.01||||0.982|TWO_SIDED|95.0|-1.026|1.003|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 72||1.003|-1.026|0.9820
71843850|NCT03777657|143201665|OTHER||LS Mean Difference|-1.74|||||TWO_SIDED|95.0|-3.55|0.06|||||Mixed effect model analysis with QLQ-STO22 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.|Analysis of Change from Baseline in QLQ-STO22 Upper Gastro-Intestinal Symptoms at Cycle 6||0.06|-3.55|
71843851|NCT04538352|143201705|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.||||||0.009||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||0.009
71809681|NCT03318523|143121066|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.26||||0.693|TWO_SIDED|95.0|-1.563|1.04|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.040|-1.563|0.6930
71809682|NCT03318523|143121066|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.03||||0.9606|TWO_SIDED|95.0|-1.053|1.001|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||1.001|-1.053|0.9606
71843852|NCT04538352|143201706|OTHER|p value of contrast difference compared from MDI to Semaglutide group at specific time point, testing whether contrast difference is equal to 0, which means there is no difference between two groups. The determination of statistical significance was made using Bonferroni-adjusted p-value, setting the significance threshold at 0.01 after multiplicity correction.|||||<|0.001||||||p value is adjusted for the multiple comparison. The significance threshold is set to 0.01.|Bonferroni-adjusted p-value|||"Linear mixed effect model was conducted for each endpoint to assess mean change at each time point, with time, treatment groups, the interaction of treatment groups and time, and baseline variables included and adjusted in each model.~Mean change difference between patients with MDI and those with Semaglutide (MDI - Semaglutide)"||||<0.001
71843853|NCT01617369|143201759|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists||||<.05
71843854|NCT01574716|143201806|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.6562|TWO_SIDED|95.0|0.77|1.5|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.50|0.77|= 0.6562
71843855|NCT01574716|143201807|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.4469|TWO_SIDED|95.0|0.82|1.57|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.57|0.82|=0.4469
71676354|NCT05338502|142870475|SUPERIORITY||Geometric LS Mean Ratio|1.0|||||TWO_SIDED|90.0|0.888|1.13|||ANOVA|||Fed State||1.13|0.888|
71809683|NCT03318523|143121066|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.24||||0.6512|TWO_SIDED|95.0|-1.269|0.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart I Score at Week 96||0.794|-1.269|0.6512
71809684|NCT03318523|143121067|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.44||||0.5497|TWO_SIDED|95.0|-1.889|1.007|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.007|-1.889|0.5497
71809685|NCT03318523|143121067|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.0||||0.998|TWO_SIDED|95.0|-1.2|1.197|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.197|-1.200|0.9980
71809686|NCT03318523|143121067|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8069|TWO_SIDED|95.0|-1.374|1.07|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 52||1.070|-1.374|0.8069
71809687|NCT03318523|143121068|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.21||||0.7968|TWO_SIDED|95.0|-1.786|1.372|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.372|-1.786|0.7968
71809688|NCT03318523|143121068|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.53||||0.4211|TWO_SIDED|95.0|-0.766|1.827|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.827|-0.766|0.4211
71809689|NCT03318523|143121068|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.15||||0.8166|TWO_SIDED|95.0|-1.448|1.143|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 72||1.143|-1.448|0.8166
71809690|NCT03318523|143121068|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.53||||0.5535|TWO_SIDED|95.0|-2.31|1.24|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.240|-2.310|0.5535
71809691|NCT03318523|143121068|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.52||||0.4654|TWO_SIDED|95.0|-0.881|1.922|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.922|-0.881|0.4654
71809692|NCT03318523|143121068|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.36||||0.6184|TWO_SIDED|95.0|-1.051|1.763|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart II Score at Week 96||1.763|-1.051|0.6184
71843856|NCT01574716|143201808|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.3153|TWO_SIDED|95.0|0.82|1.83|||Log Rank|Two-sided log-rank test|Based on Cox PH model|||1.83|0.82|0.3153
71843857|NCT01574716|143201809|SUPERIORITY||Difference|-0.6|||=|1|TWO_SIDED|95.0|-12.0|10.9|||Log Rank|Two-sided log-rank test|Based on Cox PH model|Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.||10.9|-12.0|= 1.000
71895354|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.09|0.21||||||Compared with Baseline (Pre-breakfast)||0.21|-0.09|
71895355|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|0.16|0.45||||||Compared with Baseline (Pre-breakfast)||0.45|0.16|
71809693|NCT03318523|143121069|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.59||||0.7274|TWO_SIDED|95.0|-2.742|3.925|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.925|-2.742|0.7274
71843858|NCT02438137|143201812|SUPERIORITY|In multiple linear regression models, the effect of DMF treatment on mean RDI change (beta-coefficient) was -11.3 respiratory events per hour (p=0.0124).|beta-coefficient for treatment effect|-11.3|STANDARD_ERROR_OF_MEAN|4.3||0.0124|TWO_SIDED||||||Regression, Linear|||Multiple linear regression models were used to calculate treatment effect (DMF or placebo) on mean RDI change, controlling for change in age, gender, BMI, time spent in supine sleep, and time spent in REM sleep.|A mixed effects model, which treated RDI as a repeated measure and used individual ID as random effect, adjusted for age, gender, BMI, time spent in supine sleep, was also conducted. In this model, the effect of DMF compared to placebo, controlling for all other covariates, is a 28% decrease in Month 4 RDI (p=0.033).|||0.0124
71843859|NCT04868617|143201860|SUPERIORITY||Mean Difference (Final Values)|-0.2|||=|0.015|TWO_SIDED|95.0|-0.3|-0.03|||Mixed Models Analysis|||||-0.03|-0.3|=0.015
71843860|NCT04868617|143201861|SUPERIORITY||Mean Difference (Final Values)|-0.8|||=|0.035|TWO_SIDED|95.0|-1.5|-0.1|||Mixed Models Analysis|||||-0.1|-1.5|=0.035
71843861|NCT03455985|143201892|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.4||0.09|TWO_SIDED||||||Regression, Linear|||||||0.09
71809694|NCT03318523|143121069|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.66||||0.6385|TWO_SIDED|95.0|-2.094|3.411|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||3.411|-2.094|0.6385
71809695|NCT03318523|143121069|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, baseline MDS-UPDRS score, baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.1||||0.9467|TWO_SIDED|95.0|-2.718|2.91|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 52||2.910|-2.718|0.9467
71809696|NCT03318523|143121070|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.85||||0.6112|TWO_SIDED|95.0|-2.423|4.114|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||4.114|-2.423|0.6112
71809697|NCT03318523|143121070|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.86||||0.527|TWO_SIDED|95.0|-1.806|3.52|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||3.520|-1.806|0.5270
71809698|NCT03318523|143121070|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.06||||0.9673|TWO_SIDED|95.0|-2.608|2.719|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 72||2.719|-2.608|0.9673
71809699|NCT03318523|143121070|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.65||||0.7455|TWO_SIDED|95.0|-3.274|4.569|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||4.569|-3.274|0.7455
71843862|NCT03455985|143201893|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
71843863|NCT03455985|143201894|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71843864|NCT03455985|143201895|SUPERIORITY||Mean Difference (Final Values)|-26.5|STANDARD_ERROR_OF_MEAN|30.3||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
71843865|NCT02347332|143201927|SUPERIORITY|||||||0.8329|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.8329
71895356|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|80.0|-0.56|-0.36||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.36|-0.56|
71843866|NCT02347332|143201928|SUPERIORITY|||||||0.3576|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.3576
71843867|NCT02347332|143201929|SUPERIORITY|||||||0.467|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.467
71809700|NCT03318523|143121070|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|-0.1||||0.9506|TWO_SIDED|95.0|-3.192|2.997|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||2.997|-3.192|0.9506
71809701|NCT03318523|143121070|SUPERIORITY|Adjusted mean, difference with delayed start group, 95% CI, and p-value were based on an MMRM model, with change from baseline in MDS-UPDRS score as dependent variable and with fixed effects of treatment group, time, treatment group-by-time interaction, region, PD subtype, prior use of PD medication, corresponding baseline MDS-UPDRS score, corresponding baseline MDS-UPDRS by time interaction, baseline striatum SBR values and baseline striatum SBR value by time interaction.|Difference|0.69||||0.6643|TWO_SIDED|95.0|-2.422|3.794|||Mixed Model for Repeated Measures|||Change from Baseline in MDS-UPDRS Subpart III Score at Week 96||3.794|-2.422|0.6643
71809702|NCT03318523|143121071|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.005||||0.8274|TWO_SIDED|95.0|-0.0548|0.0438|||Mixed Model for Repeated Measures|||||0.0438|-0.0548|0.8274
71809703|NCT03318523|143121071|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.6671|TWO_SIDED|95.0|-0.0504|0.0323|||Mixed Model for Repeated Measures|||||0.0323|-0.0504|0.6671
71809704|NCT03318523|143121071|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.033||||0.1313|TWO_SIDED|95.0|-0.0751|0.0098|||Mixed Model for Repeated Measures|||||0.0098|-0.0751|0.1313
71809705|NCT03318523|143121072|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.009||||0.7079|TWO_SIDED|95.0|-0.0562|0.0382|||Mixed Model for Repeated Measures|||||0.0382|-0.0562|0.7079
71809706|NCT03318523|143121072|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.0||||0.9835|TWO_SIDED|95.0|-0.04|0.0392|||Mixed Model for Repeated Measures|||||0.0392|-0.0400|0.9835
71809707|NCT03318523|143121072|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.027||||0.1869|TWO_SIDED|95.0|-0.0682|0.0134|||Mixed Model for Repeated Measures|||||0.0134|-0.0682|0.1869
71809708|NCT03318523|143121073|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.008||||0.7585|TWO_SIDED|95.0|-0.0625|0.0456|||Mixed Model for Repeated Measures|||||0.0456|-0.0625|0.7585
71809709|NCT03318523|143121073|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|0.006||||0.7808|TWO_SIDED|95.0|-0.0391|0.052|||Mixed Model for Repeated Measures|||||0.0520|-0.0391|0.7808
71809710|NCT03318523|143121073|SUPERIORITY|Adjusted mean, difference with placebo, 95% CI, and p-value were based on an MMRM model, with change from baseline in DaT/SPECT parameter as dependent variable and with fixed effects of treatment group, region, time, treatment group-by-time interaction, baseline MDS-UPDRS part I+II+III total score, baseline MDS-UPDRS part I+II+III total score by time interaction, baseline DaT/SPECT values and baseline DaT/SPECT by time interaction.|Difference|-0.022||||0.3532|TWO_SIDED|95.0|-0.0691|0.0248|||Mixed Model for Repeated Measures|||||0.0248|-0.0691|0.3532
71809711|NCT03581981|143121075|SUPERIORITY|see statistical plan|Mean Difference (Final Values)|-3.6||||0.33|TWO_SIDED|95.0|-10.7|3.6|||Mixed Models Analysis|||||3.6|-10.7|0.33
71809712|NCT03581981|143121076|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
71809713|NCT03581981|143121077|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.89|TWO_SIDED||||||Mixed Models Analysis|||||||0.89
71809714|NCT03581981|143121078|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.99|TWO_SIDED|95.0|-3.6|3.6|||Mixed Models Analysis|||||3.6|-3.6|0.99
71809715|NCT03581981|143121079|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.52|TWO_SIDED|95.0|-7.3|3.7|||Mixed Models Analysis|||||3.7|-7.3|0.52
71809716|NCT03581981|143121080|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5|TWO_SIDED|95.0|-1.4|2.9|||Mixed Models Analysis|||||2.9|-1.4|0.50
71676355|NCT05338502|142870477|SUPERIORITY||Geometric LS Mean Ratio|0.818|||||TWO_SIDED|90.0|0.68|0.985|||ANOVA|||Fasted State||0.985|0.680|
71676356|NCT05338502|142870477|SUPERIORITY||Geometric LS Mean Ratio|0.782|||||TWO_SIDED|90.0|0.645|0.949|||ANOVA|||Fed state||0.949|0.645|
71676357|NCT01250873|142870492|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.17|||||TWO_SIDED|90.0|1.06|1.3|||ANOVA|||||1.30|1.06|
71676358|NCT01250873|142870493|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.14|||||TWO_SIDED|90.0|1.01|1.28|||ANOVA|||||1.28|1.01|
71809717|NCT03581981|143121081|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
71809718|NCT03581981|143121082|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED||||||Mixed Models Analysis|||||||0.99
71809719|NCT03581981|143121083|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
71809720|NCT03581981|143121084|SUPERIORITY||Mean Difference (Final Values)|1.45||||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
71809721|NCT03581981|143121085|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
71809722|NCT03581981|143121086|SUPERIORITY||Mean Difference (Final Values)|2.87||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||0.41
71809723|NCT02080871|143121087|OTHER|This was a single-arm study designed to compare the primary outcome result to a performance goal based on published literature. The null hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of study device is at least 17%. The alternate hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of the study device is less than 17%.|||||<|0.001|||||||one-sided binomial exact test|||The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.||||<0.001
71809724|NCT00831779|143121240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.97|STANDARD_ERROR_OF_MEAN|7.4685||0.0059|TWO_SIDED|95.0|5.75|36.1||Primary endpoint was tested at alpha=0.05|ANOVA|||||36.10|5.75|0.0059
71809725|NCT00831779|143121241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.13|STANDARD_ERROR_OF_MEAN|14.4984||0.0598|TWO_SIDED|95.0|-1.22|57.48||Secondary endpoint was tested following a sequential testing procedure at alpha=0.05|ANOVA|||||57.48|-1.22|0.0598
71809726|NCT00338884|143121247|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|35.3|||||TWO_SIDED|95.0|26.7|44.8|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||44.8|26.7|
71809727|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.5581|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5581
71843868|NCT02347332|143201930|SUPERIORITY|||||||0.243|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.243
71676359|NCT01250873|142870494|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8281|TWO_SIDED|90.0|-0.5|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-0.50|0.8281
71676360|NCT01250873|142870495|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.27|||||TWO_SIDED|90.0|1.17|1.39|||ANOVA|||||1.39|1.17|
71676361|NCT01250873|142870496|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.22|||||TWO_SIDED|90.0|1.1|1.36|||ANOVA|||||1.36|1.10|
71676362|NCT01250873|142870497|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|0.00|0.3125
71676363|NCT02278939|142870499|SUPERIORITY|||||||0.003||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months||||0.003
71676364|NCT02278939|142870500|SUPERIORITY|||||||0.001||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months||||.001
71676365|NCT02278939|142870501|SUPERIORITY|||||||0.002||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months||||.002
71676366|NCT01680861|142870509|SUPERIORITY_OR_OTHER|||||||0.32|||||||Log Rank|||||||0.32
71676367|NCT01680861|142870510|SUPERIORITY_OR_OTHER|||||||0.99|||||||Log Rank|||||||0.99
71809728|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.7635|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.7635
71809729|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.8366|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8366
71809730|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.0278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0278
71809731|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.1988|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1988
71809732|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.2898|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2898
71809733|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.3567|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3567
71809734|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.4547|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.4547
71809735|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
71809736|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.3259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3259
71809737|NCT00338884|143121253|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
71809738|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.7154|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7154
71809739|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6263
71843869|NCT02347332|143201931|SUPERIORITY|||||||0.6289|TWO_SIDED|95.0||||Threshold significance value p\<0.05|Log Rank|||||||0.6289
71843870|NCT01970007|143201932|OTHER||Freedom from MAE rate (%)|96.7|||<|0.0001|TWO_SIDED|95.0|93.5|98.6|||One-sided Exact binomial test||One-sided Exact binomial test|||98.6|93.5|<0.0001
71676368|NCT01680861|142870511|SUPERIORITY_OR_OTHER|||||||1|||||||Log Rank|||||||1.0
71676369|NCT01680861|142870512|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71809740|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.9608|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9608
71809741|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0300
71809742|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0927
71809743|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2873
71809744|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.3018|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3018
71809745|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.4161|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4161
71809746|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.3069|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3069
71809747|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2920
71809748|NCT00338884|143121254|SUPERIORITY_OR_OTHER|||||||0.2409|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2409
71809749|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
71809750|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.6251|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.6251
71843871|NCT01970007|143201933|OTHER||12-month quantitative patency rate (%)|89.9|||<|0.0001|TWO_SIDED|95.0|85.1|93.4|||Binomial test for one proportion||Binomial test for one proportion|||93.4|85.1|<0.0001
71843872|NCT01970007|143201934|OTHER||Change from Baseline Mean|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.5|-2.6||P-value is adjusted for multiplicity|paired t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05.||||-2.6|-3.5|<0.0001
71809751|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.1639|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1639
71809752|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.2782|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.2782
71676370|NCT01680861|142870513|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71676371|NCT01680861|142870514|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71676372|NCT04590586|142870532|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.6672|TWO_SIDED|95.0|0.59|2.35|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (Lanadelumab vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||2.35|0.59|0.6672
71809753|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.8627|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.8627
71809754|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4620
71809755|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.7575|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.7575
71809756|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.3566|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3566
71809757|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.2809|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.2809
71809758|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.8758|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8758
71809759|NCT00338884|143121256|SUPERIORITY_OR_OTHER|||||||0.2702|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2702
71809760|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
71809761|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.8555|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8555
71809762|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.2259|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2259
71809763|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.2074|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2074
71809764|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.4779|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4779
71809765|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.3628|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3628
71809766|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5460
71809767|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.3637|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3637
71809768|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.2229|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2229
71809769|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.9759|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9759
71809770|NCT00338884|143121257|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
71809771|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.5784|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)||||0.5784
71809772|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.9625|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.9625
71809773|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.8519
71809774|NCT00338884|143121259|SUPERIORITY_OR_OTHER||Wilcoxon Rank Sum Test|||||0.0513|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.0513
71809775|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.4051|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.4051
71809776|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.2548|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.2548
71809777|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.5091|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.5091
71809778|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.3133|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.3133
71809779|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.9278|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.9278
71809780|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.4070
71809781|NCT00338884|143121259|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.2703
71809782|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.7267|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.7267
71809783|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.8286|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8286
71809784|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.6867|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6867
71809785|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.0450
71809786|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1740
71809787|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.2703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2703
71809788|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.3659|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3659
71809789|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.3391|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3391
71809790|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9800
71809791|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3350
71809792|NCT00338884|143121260|SUPERIORITY_OR_OTHER|||||||0.2179|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2179
71809793|NCT00338884|143121263|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0680
71809794|NCT00338884|143121264|SUPERIORITY_OR_OTHER|||||||0.1159|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1159
71809795|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.8519|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.8519
71809796|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.5879|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.5879
71809797|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.4757|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.4757
71809798|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.1933|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.1933
71809799|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.4187|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.4187
71809800|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.3795|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.3795
71809801|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||1.0000
71809802|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.6333|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.6333
71809803|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.8679|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.8679
71809804|NCT00338884|143121266|SUPERIORITY_OR_OTHER|||||||0.592|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.5920
71809805|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.6939|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6939
71809806|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.5871|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5871
71809807|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.4572|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4572
71809808|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1120
71809809|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.4896|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4896
71809810|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.2369|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.2369
71809811|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.6709|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6709
71809812|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.6382|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6382
71809813|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.8481|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8481
71809814|NCT00338884|143121267|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
71809815|NCT00338884|143121269|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD||||0.0292
71809816|NCT00338884|143121270|SUPERIORITY_OR_OTHER|||||||0.1087|TWO_SIDED||||||Wilcoxon Rank Sum Test|||CR or PR or (SD \> = 12 Weeks) Versus PD||||0.1087
71809817|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.3386|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)||||0.3386
71843873|NCT01970007|143201935|OTHER||Change from Baseline Mean|-4.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.7||p-value is adjusted for multiplicity.|pair t-test|A paired t-test with p-values adjusted for multiple comparisons using the Holm's procedure to control for a family-wise Type I error rate of 0.05||||-3.7|-4.7|<0.0001
71843874|NCT00747565|143201972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||ETDRS line scores used for statistical comparisons with mean Snellen values reported above.||||<0.0001
71843875|NCT05120856|143201980|SUPERIORITY||Slope|-1.106369|STANDARD_ERROR_OF_MEAN|0.4985347||0.026|TWO_SIDED|95.0|-2.083479|-0.129259||This is the p value for the overall group x time interaction.|Mixed Models Analysis|The model compared groups' change across all time points Time was coded as a continuous variable (i.e., 0, 4, 8, and 16).|This is the effect estimate for the group x time interaction.|||-0.129259|-2.083479|.026
71843876|NCT05120856|143201980|SUPERIORITY||Mean Difference (Final Values)|5.025|STANDARD_ERROR_OF_MEAN|8.737||0.565|TWO_SIDED|95.0|-12.098|22.149|||t-test, 2 sided|||planned between-group post-hoc comparison at 4-week follow-up||22.149|-12.098|.565
71843877|NCT05120856|143201980|SUPERIORITY||Mean Difference (Final Values)|-3.349|STANDARD_ERROR_OF_MEAN|8.891||0.706|TWO_SIDED|95.0|-20.774|14.077|||t-test, 2 sided|||Planned post-hoc comparison between groups at 8-week follow-up||14.077|-20.774|.706
71843878|NCT05120856|143201980|SUPERIORITY||Mean Difference (Final Values)|-6.921|STANDARD_ERROR_OF_MEAN|9.394||0.461|TWO_SIDED|95.0|-25.332|11.491|||t-test, 2 sided|||Planned post-hoc comparison between groups at 16-week follow-up||11.491|-25.332|.461
71809818|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.1949|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)||||0.1949
71809819|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.7037|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)||||0.7037
71809820|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.5748|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)||||0.5748
71809821|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.747|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)||||0.7470
71809822|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.4703|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)||||0.4703
71809823|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.8162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)||||0.8162
71809824|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.5465|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)||||0.5465
71809825|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.3495|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)||||0.3495
71809826|NCT00338884|143121272|SUPERIORITY_OR_OTHER|||||||0.6397|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)||||0.6397
71809827|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.4632|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4632
71809828|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.1701|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.1701
71809829|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.8204|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8204
71843879|NCT05120856|143201980|SUPERIORITY||Slope|-1.0838|STANDARD_ERROR_OF_MEAN|0.4798||0.0252|TWO_SIDED|95.0|-2.0229626|-0.1419329||This is the p value for the group x time interaction|Mixed Models Analysis|||In an additional sensitivity analysis, past-week alcohol use data was excluded if a participant reported having been in residential/inpatient treatment where they could not access alcohol for the whole of the past week at the time of follow-up. This resulted in data for one participant in the ApBM group being excluded at week 8, and 1 control being excluded at week 16.||-0.1419329|-2.0229626|.0252
71809830|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.5162|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.5162
71809831|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.9437|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9437
71809832|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.4013|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.4013
71809833|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.9595|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.9595
71809834|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.6249|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.6249
71809835|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.3731|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.3731
71809836|NCT00338884|143121273|SUPERIORITY_OR_OTHER|||||||0.8263|TWO_SIDED||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or \[SD \> = 12 Weeks\] Versus PD)||||0.8263
71809837|NCT01970982|143121283|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.09|||<|0.001|TWO_SIDED|95.0|18.41|28.95||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||28.95|18.41|<0.001
71813675|NCT01114204|143129657|NON_INFERIORITY|The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.|Treatment Difference|2.58||||0.2833|TWO_SIDED|95.0|-3.89|9.06|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information."||9.06|-3.89|0.2833
71676373|NCT04590586|142870533|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8779|TWO_SIDED|95.0|0.77|1.24|||Stratified log-rank test|Stratified by baseline score of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), and geographic region.|Hazard ratio (apremilast vs. placebo) from a Cox regression model including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.24|0.77|0.8779
71676374|NCT04590586|142870545|OTHER||Risk Difference (RD)|-4.0||||0.3773|TWO_SIDED|95.0|-12.9|4.9|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||4.9|-12.9|0.3773
71676375|NCT04590586|142870545|OTHER||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.52|1.28|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.28|0.52|
71676376|NCT04590586|142870546|OTHER||Risk Difference (RD)|-2.9||||0.4846|TWO_SIDED|95.0|-11.2|5.3|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||5.3|-11.2|0.4846
71676377|NCT04590586|142870546|OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.51|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.37|0.51|
71676378|NCT04590586|142870547|OTHER||Risk Difference (RD)|0.2||||0.9665|TWO_SIDED|95.0|-7.3|7.6|||Regression, Logistic||Risk difference is from a logistic regression including baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||7.6|-7.3|0.9665
71676379|NCT04590586|142870547|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.59|1.74|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.74|0.59|
71809838|NCT01970982|143121284|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|52.86|||<|0.001|TWO_SIDED|95.0|45.67|61.17||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||61.17|45.67|<0.001
71809839|NCT01970982|143121285|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|15.68|||<|0.001|TWO_SIDED|95.0|13.09|18.78||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||18.78|13.09|<0.001
71813676|NCT00991341|143129665|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.44|TWO_SIDED|95.0|-0.6|0.26|||ANCOVA|The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.|||0.26|-0.60|0.44
71813677|NCT00991341|143129666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.5|TWO_SIDED|95.0|0.48|1.43|||Regression, Cox|The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.|The longer storage duration arm is the reference category.|||1.43|0.48|0.50
71676380|NCT04590586|142870548|OTHER||Odds Ratio (OR)|1.02||||0.9119|TWO_SIDED|95.0|0.71|1.46|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 8||1.46|0.71|0.9119
71676381|NCT04590586|142870548|OTHER||Odds Ratio (OR)|1.09||||0.6475|TWO_SIDED|95.0|0.75|1.58|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 15||1.58|0.75|0.6475
71676382|NCT04590586|142870548|OTHER||Odds Ratio (OR)|0.98||||0.9071|TWO_SIDED|95.0|0.64|1.48|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|Day 29||1.48|0.64|0.9071
71676383|NCT04590586|142870549|OTHER||Odds Ratio (OR)|1.15||||0.4507|TWO_SIDED|95.0|0.8|1.66|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.66|0.80|0.4507
71676384|NCT04590586|142870550|OTHER||Odds Ratio (OR)|0.99||||0.9741|TWO_SIDED|95.0|0.64|1.53|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.53|0.64|0.9741
71676385|NCT04590586|142870551|OTHER||Odds Ratio (OR)|1.04||||0.8754|TWO_SIDED|95.0|0.64|1.7|||Proportional odds model||Odds ratio (Apremilast vs. Placebo) from a proportional odds model including the baseline clinical severity of 2 on the 8-point ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), region, and treatment arm as factors.|||1.70|0.64|0.8754
71676386|NCT04590586|142870552|OTHER||Risk Difference (RD)|0.2||||0.9695|TWO_SIDED|95.0|-8.7|9.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||9.1|-8.7|0.9695
71843880|NCT05120856|143201981|SUPERIORITY||Slope|-0.016|STANDARD_ERROR_OF_MEAN|0.033||0.633|TWO_SIDED|95.0|-0.08|0.05||This is the p value for the time x group interaction.|Mixed Models Analysis|||This is the test for the overall CEQ-F scores||0.05|-0.08|.633
71843881|NCT05120856|143201981|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.041||0.411|TWO_SIDED|95.0|-0.11|0.05||This is for the time x group interaction for the intensity subscale|Mixed Models Analysis|||This is for the test of the CEQ-F Intensity subscale score||0.05|-0.11|.411
71843882|NCT05120856|143201981|SUPERIORITY||Slope|-0.009|STANDARD_ERROR_OF_MEAN|0.036||0.808|TWO_SIDED|95.0|-0.08|0.06||p value for the time x group interaction for Imagery subscale|Mixed Models Analysis|||Analysis of CEQ-F Imagery subscale score||0.06|-0.08|.808
71843883|NCT05120856|143201981|SUPERIORITY||Slope|-0.006|STANDARD_ERROR_OF_MEAN|0.041||0.886|TWO_SIDED|95.0|-0.09|0.08||This is the p value for the time x group interaction for the Intrusiveness subscale score|Mixed Models Analysis|||This is for the analysis of the CEQ-F Intrusiveness subscale score||0.08|-0.09|.886
71676387|NCT04590586|142870552|OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.64|1.59|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 8||1.59|0.64|
71676388|NCT04590586|142870552|OTHER||Risk Difference (RD)|-2.4||||0.6236|TWO_SIDED|95.0|-11.9|7.1|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||7.1|-11.9|0.6236
71676389|NCT04590586|142870552|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.59|1.37|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 15||1.37|0.59|
71676390|NCT04590586|142870552|OTHER||Risk Difference (RD)|-6.2||||0.1664|TWO_SIDED|95.0|-14.9|2.5|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||2.5|-14.9|0.1664
71843884|NCT05120856|143201982|SUPERIORITY||Slope|0.083|STANDARD_ERROR_OF_MEAN|0.066||0.207|TWO_SIDED|95.0|-0.046|0.212||This is the p value for the time x group interaction|Mixed Models Analysis|||||0.212|-0.046|.207
71843885|NCT05120856|143201983|SUPERIORITY||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.166||0.876|TWO_SIDED|95.0|-0.352|0.3||This is the p value for the group x time interaction.|Mixed Models Analysis|||||0.300|-0.352|.876
71843886|NCT05120856|143201984|SUPERIORITY||Slope|-0.069|STANDARD_ERROR_OF_MEAN|0.037||0.064|TWO_SIDED|95.0|-0.142|0.004||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.004|-0.142|.064
71843887|NCT05120856|143201985|SUPERIORITY||Slope|-0.059|STANDARD_ERROR_OF_MEAN|0.143||0.679|TWO_SIDED|95.0|-0.338|0.22||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.220|-0.338|.679
71843888|NCT05120856|143201987|SUPERIORITY||Slope|0.072|STANDARD_ERROR_OF_MEAN|0.086||0.403|TWO_SIDED|95.0|-0.097|0.24||This is the p value for the group x time interaction|Mixed Models Analysis|||||0.240|-0.097|.403
71843889|NCT05120856|143201988|SUPERIORITY||Slope|-0.052|STANDARD_ERROR_OF_MEAN|0.037||0.161|TWO_SIDED|95.0|-0.126|0.021||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of psychological well-being ratings.||0.021|-0.126|.161
71843890|NCT05120856|143201988|SUPERIORITY||Slope|-0.029|STANDARD_ERROR_OF_MEAN|0.036||0.425|TWO_SIDED|95.0|-0.099|0.042||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of physical well-being ratings||0.042|-0.099|.425
71843891|NCT05120856|143201988|SUPERIORITY||Slope|-0.039|STANDARD_ERROR_OF_MEAN|0.034||0.247|TWO_SIDED|95.0|-0.106|0.027||This is the p value for the group x time interaction|Mixed Models Analysis|||Linear mixed-effects model analysis of quality of life ratings||0.027|-0.106|.247
71843892|NCT05120856|143201989|SUPERIORITY||Slope|3.645|STANDARD_ERROR_OF_MEAN|10.369||0.725|TWO_SIDED|95.0|-16.68|23.97||This is the p value for the group x time interaction|Mixed Models Analysis|||||23.97|-16.68|.725
71676391|NCT04590586|142870552|OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.45|1.15|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|Analysis of clinical recovery on Day 29||1.15|0.45|
71676392|NCT04590586|142870553|OTHER||Risk Difference (RD)|-0.5||||0.9043|TWO_SIDED|95.0|-9.3|8.3|||Regression, Logistic||Risk difference is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||8.3|-9.3|0.9043
71676393|NCT04590586|142870553|OTHER||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.62|1.54|||||Odds ratio (apremilast vs. placebo) is from a logistic regression including the baseline clinical severity of 2 on the ordinal scale for clinical severity (yes/no), remdesivir use at baseline (yes/no), geographic region, and treatment arm as factors.|||1.54|0.62|
71676394|NCT03063086|142870570|SUPERIORITY||Mean Difference (Final Values)|0.172|||<|0.0001|TWO_SIDED|95.0|0.137|0.208|||Mixed Models Analysis|||||0.208|0.137|<0.0001
71676395|NCT03063086|142870570|SUPERIORITY||Median Difference (Final Values)|0.159|||<|0.0001|TWO_SIDED|95.0|0.123|0.195|||Mixed Models Analysis|||||0.195|0.123|<0.0001
71676396|NCT03063086|142870575|SUPERIORITY||Mean Difference (Final Values)|0.124|||<|0.0001|TWO_SIDED|95.0|0.086|0.161|||Mixed Models Analysis|||||0.161|0.086|<0.0001
71809840|NCT01970982|143121286|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|47.1|||<|0.001|TWO_SIDED|95.0|44.3|50.08||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."||50.08|44.30|<0.001
71809841|NCT00951483|143121287|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|-2.65||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.||||.001
71809842|NCT00951483|143121288|SUPERIORITY_OR_OTHER||z-score|-4.544|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.||||<.001
71809843|NCT00951483|143121289|SUPERIORITY_OR_OTHER||z-score|-4.627|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.||||<.001
71809844|NCT00951483|143121290|SUPERIORITY_OR_OTHER||z-score|-4.624|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.||||<.001
71809845|NCT00951483|143121291|SUPERIORITY_OR_OTHER||z-score|-4.51|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.||||<.001
71809846|NCT00951483|143121292|SUPERIORITY_OR_OTHER||z-score|-4.435|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.||||<.001
71809847|NCT00951483|143121293|SUPERIORITY_OR_OTHER||z-score|-3.911|||<|0.001|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.||||<.001
71809848|NCT02342886|143121303|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% confidence interval (CI) for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|9.88|||||TWO_SIDED|95.0|-4.13|23.89|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||23.89|-4.13|
71843893|NCT02549352|143202003|SUPERIORITY||Ratio of clearance rates|7.83|||<|0.001|TWO_SIDED|95.0|2.58|23.71|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|||23.71|2.58|<0.001
71843894|NCT02549352|143202004|SUPERIORITY||Ratio of clearance rates|5.91|||<|0.001|TWO_SIDED|95.0|3.32|10.51|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||10.51|3.32|<0.001
71843895|NCT02549352|143202005|SUPERIORITY||Ratio of clearance rates|7.59|||<|0.001|TWO_SIDED|95.0|3.7|15.61|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||15.61|3.70|<0.001
71895357|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||||TWO_SIDED|80.0|-0.45|-0.03||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.03|-0.45|
71809849|NCT02342886|143121304|NON_INFERIORITY|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was \< 12%.|Treatment difference: unfavourable rate|6.62|||||TWO_SIDED|95.0|-2.15|15.4|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).|||15.40|-2.15|
71809850|NCT01569438|143121305|OTHER||Mean Difference|-0.7||||0.0734|TWO_SIDED|90.0|-1.6|0.2||one-sided|Mixed Model with Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||0.2|-1.6|0.0734
71809851|NCT01569438|143121306|OTHER||Mean Difference|-1.0||||0.2726|TWO_SIDED|90.0|-3.9|1.8||one-sided|Mixed Model With Repeated Measures|||MMRM approach was used to model the change from baseline as a function of treatment, week, treatment by week interaction, baseline score, and baseline score by week interaction.||1.8|-3.9|0.2726
71809852|NCT01569438|143121307|OTHER||Mean Difference|-0.3||||0.3603|TWO_SIDED|90.0|-1.7|1.1||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||1.1|-1.7|0.3603
71809853|NCT01569438|143121308|OTHER||Mean Difference|-1.5||||0.1183|TWO_SIDED|90.0|-3.5|0.6||one-sided|ANCOVA|||The one-way ANCOVA model was used to calculate change from baseline as a function of treatment and baseline score.||0.6|-3.5|0.1183
71895358|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|80.0|-0.08|0.48||||||Compared with Baseline (Pre-lunch)||0.48|-0.08|
71895359|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|80.0|0.38|1.03||||||Compared with Baseline (Pre-lunch)||1.03|0.38|
71843896|NCT02549352|143202006|SUPERIORITY||Week 8 AK count ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.25|0.36||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.||0.36|0.25|<0.001
71843897|NCT05048394|143202007|EQUIVALENCE|Equivalence is defined as a difference of 0.|||||<|0.001||||||Threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71843898|NCT05048394|143202008|EQUIVALENCE|Equivalence is defined as a difference of 0.||||||0.14||||||Threshold for significance was p = 0.05.|Wilcoxon (Mann-Whitney)|||||||0.14
71843899|NCT03614663|143202023|SUPERIORITY|||||||0.321|||||||MMRM - Mixed model for repeated measures|||||||0.321
71843900|NCT03614663|143202024|SUPERIORITY|||||||0.149|||||||MMRM - Mixed model for repeated measures|||||||0.149
71843901|NCT03614663|143202025|SUPERIORITY|||||||0.607|||||||MMRM - Mixed model for repeated measures|||||||0.607
71843902|NCT03614663|143202026|SUPERIORITY|||||||0.426|||||||ANOVA|||||||0.426
71843903|NCT03614663|143202027|SUPERIORITY|||||||0.02|||||||MMRM - Mixed model for repeated measures|||||||0.02
71843904|NCT03614663|143202028|SUPERIORITY|||||||0.091|||||||MMRM - Mixed model for repeated measures|||||||0.091
71843905|NCT03614663|143202029|SUPERIORITY|||||||0.135|||||||MMRM - Mixed model for repeated measures|||||||0.135
71843906|NCT03614663|143202030|SUPERIORITY|||||||0.056|||||||MMRM - Mixed model for repeated measures|||||||0.056
71843907|NCT01128595|143202031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.515|||||TWO_SIDED|95.0|0.33|0.701||||||||0.701|0.330|
71843908|NCT01128595|143202031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|||||TWO_SIDED|95.0|0.355|0.73||||||||0.730|0.355|
71843909|NCT01128595|143202031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|||||TWO_SIDED|95.0|0.001|0.388||||||||0.388|0.001|
71843910|NCT01128595|143202031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|||||TWO_SIDED|95.0|-0.198|0.143||||||||0.143|-0.198|
71843911|NCT01128595|143202031|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|95.0|0.14|0.501||||||||0.501|0.140|
71843912|NCT01128595|143202034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.332|0.636||||||||0.636|0.332|
71843913|NCT01128595|143202034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.484|||||TWO_SIDED|95.0|0.33|0.638||||||||0.638|0.330|
71843914|NCT01128595|143202034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|||||TWO_SIDED|95.0|0.009|0.327||||||||0.327|0.009|
71843915|NCT01128595|143202034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.14|0.14||||||||0.140|-0.140|
71676397|NCT02218736|142870576|SUPERIORITY|||||||0.0095|||||||t-test, 1 sided|||||||0.0095
71676398|NCT02218736|142870577|SUPERIORITY|||||||0.0345|||||||t-test, 1 sided|||||||0.0345
71676399|NCT02218736|142870578|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||||||0.430
71843916|NCT01128595|143202034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.316|||||TWO_SIDED|95.0|0.168|0.464||||||||0.464|0.168|
71843917|NCT01128595|143202035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|||||TWO_SIDED|95.0|0.031|0.393||||||||0.393|0.031|
71843918|NCT01128595|143202035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.341|||||TWO_SIDED|95.0|0.147|0.536||||||||0.536|0.147|
71843919|NCT01128595|143202035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.477|||||TWO_SIDED|95.0|0.282|0.672||||||||0.672|0.282|
71843920|NCT01128595|143202035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|0.066|0.463||||||||0.463|0.066|
71843921|NCT01128595|143202035|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||||TWO_SIDED|95.0|-0.072|0.343||||||||0.343|-0.072|
71843922|NCT01128595|143202036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|||||TWO_SIDED|95.0|-0.037|0.215||||||||0.215|-0.037|
71843923|NCT01128595|143202036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||||TWO_SIDED|95.0|0.101|0.371||||||||0.371|0.101|
71843924|NCT01128595|143202036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|||||TWO_SIDED|95.0|0.127|0.398||||||||0.398|0.127|
71843925|NCT01128595|143202036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|||||TWO_SIDED|95.0|0.036|0.312||||||||0.312|0.036|
71843926|NCT01128595|143202036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||||TWO_SIDED|95.0|-0.118|0.171||||||||0.171|-0.118|
71843927|NCT00372775|143202044|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|1.6|||||TWO_SIDED|95.0|0.0|8.8|||||Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution|||8.8|0.0|
71843928|NCT00372775|143202046|SUPERIORITY_OR_OTHER||ORR (percent)|4.3|||||TWO_SIDED|95.0|0.1|21.9|||||Two-Sided CI from Exact Method using the F Distribution|||21.9|0.1|
71843929|NCT00372775|143202049|SUPERIORITY_OR_OTHER||Percentage|23.4|||||TWO_SIDED|95.0|14.0|34.3|||||Probability of survival along with the corresponding 2-sided confidence interval for the log \[-log(one-year survival rate)\] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival|||34.3|14.0|
71843930|NCT00724126|143202082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.03
71843931|NCT00724126|143202083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.||||||0.02
71843932|NCT02502526|143202087|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
71843933|NCT02502526|143202088|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
71843934|NCT02502526|143202088|SUPERIORITY|||||||0.605|||||||ANCOVA|||||||0.605
71843935|NCT02502526|143202089|SUPERIORITY|||||||0.52|||||||ANCOVA|||||||0.520
71843936|NCT02502526|143202089|SUPERIORITY|||||||0.817|||||||ANCOVA|||||||0.817
71843937|NCT00112359|143202090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.98||||0.0006|TWO_SIDED|95.0|3.5|12.47||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.||12.47|3.50|0.0006
71895360|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||||TWO_SIDED|80.0|-0.26|0.37||||||Compared with Baseline (Pre-lunch)||0.37|-0.26|
71809854|NCT00452387|143121310|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Fisher Exact|||The test of association of PSA and imaging response tests the null hypothesis that the proportion of cases exhibiting PSA response is the same for patients with and without a favorable imaging response. A 2x2 table was constructed based on the number of the patients in imaging response (favorable and unfavorable) and PSA response (\>50% reduction and \<=50% reduction). The Fisher's exact test was used to test this hypothesis.||||0.55
71809855|NCT00579280|143121316|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71809856|NCT00579280|143121317|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71676400|NCT01598090|142870607|NON_INFERIORITY|Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.||||||0.0855||||||Non-inferiority testing is based on lower limit of confidence interval.|Mantel Haenszel|||||||0.0855
71809857|NCT00579280|143121318|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71809858|NCT00579280|143121319|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<.05
71809859|NCT00579280|143121320|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71809860|NCT00579280|143121321|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71809861|NCT00579280|143121322|SUPERIORITY||||||<|0.05|||||||Chi-squared|Differences in response (70% or greater improvement) and remission (50% or greater improvement) rates between the groups.||||||<0.05
71809862|NCT00579280|143121323|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71843938|NCT00112359|143202091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33||||0.0154|TWO_SIDED|95.0|1.22|11.43||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.||11.43|1.22|0.0154
71843939|NCT00112359|143202094|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.294|||<|0.0001|TWO_SIDED|95.0|6.288|14.299||Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.|ANCOVA|ANCOVA model included treatment, disease severity (FEV1 \>50% or \<=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.||14.299|6.288|<0.0001
71809863|NCT00579280|143121324|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71809864|NCT00579280|143121325|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71809865|NCT00579280|143121326|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71809866|NCT01693068|143121327|OTHER|A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system \[IVRS\] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.|Hazard Ratio (HR)|0.59||||0.0022|TWO_SIDED|95.0|0.42|0.83|||Stratified Log Rank Test||The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.|||0.83|0.42|0.0022
71809867|NCT02510144|143121338|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||Negative cultures were compared on the treated side vs the non-treated side||||0.68
71676401|NCT04791319|142870617|SUPERIORITY||MH weights|7.1||||0.489|TWO_SIDED|95.0|-12.1|26.2||Threshold for significance at 0.05 level.|Chi-squared|||||26.2|-12.1|0.489
71676402|NCT04791319|142870617|SUPERIORITY||MH Weights|7.1||||0.448|TWO_SIDED|95.0|-9.4|23.7|||Chi-squared|||||23.7|-9.4|0.448
71809868|NCT02510144|143121338|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Negative cultures were compared on the treated side versus the non-treated side||||<0.01
71809869|NCT00977665|143121340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.603||||0.6984|TWO_SIDED|95.0|-3.677|2.47||A priori threshold for statistical significance is 0.05.|repeated measures model|Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.||||2.470|-3.677|0.6984
71809870|NCT00977665|143121349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.189|||||TWO_SIDED|95.0|0.646|2.186||||||||2.186|0.646|
71809871|NCT03053050|143121377|SUPERIORITY||Percentage Difference|-2.1||||0.4941|TWO_SIDED|95.0|-8.3|4.0||Difference between SEL 18 mg and Placebo, 95% confidence interval (CI) and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and Enhanced Liver Fibrosis (ELF) test score as stratification factors.|Mantel Haenszel|||||4.0|-8.3|0.4941
71809872|NCT03053050|143121377|SUPERIORITY||Percentage Difference|-0.3||||0.9321|TWO_SIDED|95.0|-6.6|6.0||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.0|-6.6|0.9321
71809873|NCT03053050|143121379|SUPERIORITY||Percentage Difference|-4.0||||0.2593|TWO_SIDED|95.0|-10.8|2.9||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.9|-10.8|0.2593
71809874|NCT03053050|143121379|SUPERIORITY||Percentage Difference|-0.9||||0.808|TWO_SIDED|95.0|-7.9|6.1||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||6.1|-7.9|0.8080
71809875|NCT03053050|143121381|SUPERIORITY||Percentage Difference|-2.0||||0.5636|TWO_SIDED|95.0|-8.7|4.8||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.8|-8.7|0.5636
71809876|NCT03053050|143121381|SUPERIORITY||Percentage Difference|-1.9||||0.5915|TWO_SIDED|95.0|-8.6|4.9||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||4.9|-8.6|0.5915
71809877|NCT03053050|143121383|SUPERIORITY||Percentage Difference|-3.2||||0.2455|TWO_SIDED|95.0|-8.5|2.2||Difference between SEL 18 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||2.2|-8.5|0.2455
71676403|NCT04791319|142870617|SUPERIORITY||MH Weights|42.0||||0.001|TWO_SIDED|95.0|22.9|61.1|||Chi-squared|||||61.1|22.9|0.001
71809878|NCT03053050|143121383|SUPERIORITY||Percentage Difference|-4.0||||0.1371|TWO_SIDED|95.0|-9.3|1.3||Difference between SEL 6 mg and Placebo, 95% CI and p-value were obtained by stratum-adjusted Mantel-Haenszel method with baseline diabetes mellitus status and ELF test score as stratification factors.|Mantel Haenszel|||||1.3|-9.3|0.1371
71809879|NCT05338333|143121394|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction, period, sequence, and habitual lens stratum) and random (subject) effects. Difference = LID210464 minus AOHG MF.|||0.00||
71809880|NCT05878197|143121399|OTHER|||||||0.024||||||Linear Mixed Models: time-effect|Mixed Models Analysis|||||||0.024
71809881|NCT05878197|143121399|OTHER|||||||0.822||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.822
71809882|NCT05878197|143121399|OTHER|||||||0.29||||||Linar mixed models: time\*group-effect|Mixed Models Analysis|||||||0.290
71809883|NCT05878197|143121399|OTHER||Mean Difference (Final Values)|1.8||||0.035|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.035
71809884|NCT05878197|143121399|OTHER||Mean Difference (Final Values)|1.8||||0.038|TWO_SIDED|95.0|0.1|3.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.4|0.1|0.038
71809885|NCT05878197|143121399|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-1.9|1.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||1.9|-1.9|1.000
71809886|NCT05878197|143121400|OTHER|||||||0.107||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.107
71809887|NCT05878197|143121400|OTHER|||||||0.996||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.996
71809888|NCT05878197|143121400|OTHER|||||||0.639||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.639
71809889|NCT05878197|143121400|OTHER||Mean Difference (Final Values)|-0.1||||0.731|TWO_SIDED|95.0|-0.6|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-0.6|0.731
71809890|NCT05878197|143121400|OTHER||Mean Difference (Final Values)|-0.4||||0.217|TWO_SIDED|95.0|-1.1|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-1.1|0.217
71809891|NCT05878197|143121400|OTHER||Mean Difference (Final Values)|-0.3||||0.253|TWO_SIDED|95.0|-0.9|0.3||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.3|-0.9|0.253
71809892|NCT05878197|143121401|OTHER|||||||0.024||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.024
71809893|NCT05878197|143121401|OTHER|||||||0.449||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.449
71809894|NCT05878197|143121401|OTHER|||||||0.786||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.786
71676404|NCT00520533|142870660|SUPERIORITY|||||||0.194|||||||t-test, 2 sided|||Comparison of Biological T1/2 at Week 1 and Week 5.||||0.194
71809895|NCT05878197|143121401|OTHER||Mean Difference (Final Values)|-3.3||||0.099|TWO_SIDED|95.0|-7.2|0.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.7|-7.2|0.099
71809896|NCT05878197|143121401|OTHER||Mean Difference (Final Values)|-3.9||||0.074|TWO_SIDED|95.0|-8.3|0.4||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||0.4|-8.3|0.074
71809897|NCT05878197|143121401|OTHER||Mean Difference (Final Values)|-1.7||||0.472|TWO_SIDED|95.0|-6.7|3.2||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||3.2|-6.7|0.472
71809898|NCT05878197|143121402|OTHER|||||||0.115||||||Linear mixed models: time-effect|Mixed Models Analysis|||||||0.115
71809899|NCT05878197|143121402|OTHER|||||||0.516||||||Linear mixed models: group-effect|Mixed Models Analysis|||||||0.516
71809900|NCT05878197|143121402|OTHER|||||||0.276||||||Linear mixed models: time\*group-effect|Mixed Models Analysis|||||||0.276
71809901|NCT05878197|143121402|OTHER||Mean Difference (Final Values)|-6.5||||0.025|TWO_SIDED|95.0|-12.2|-0.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||-0.9|-12.2|0.025
71809902|NCT05878197|143121402|OTHER||Mean Difference (Final Values)|-0.7||||0.794|TWO_SIDED|95.0|-6.4|4.9||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||4.9|-6.4|0.794
71809903|NCT05878197|143121402|OTHER||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.7|5.7||Linear mixed models: evolution pre-post|Mixed Models Analysis|||||5.7|-7.7|0.760
71809904|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
71809905|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
71809906|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Total cost comparison.||||< 0.001
71809907|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison||||< 0.001
71809908|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Inpatient cost comparison.||||< 0.001
71809909|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.||||||0.126|||||||Bang and Tsiatis|||Inpatient cost comparison||||0.126
71809910|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
71676405|NCT00520533|142870661|SUPERIORITY|||||||0.172|||||||t-test, 2 sided|||Comparison of Effective T1/2 at Week 1 and Week 5.||||0.172
71676406|NCT02397122|142870670|SUPERIORITY|||||||0.259|||||||Mann-Whitney|||Baseline||||0.259
71809911|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
71809912|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Outpatient cost comparison.||||< 0.001
71809913|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
71809914|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
71809915|NCT04295005|143121420|OTHER|Group differences in the costs incurred after treatment initiation were evaluated based on an incremental cost approach using the Bang and Tsiatis estimator with possibly censored data.|||||<|0.001|||||||Bang and Tsiatis|||Medication cost comparison.||||< 0.001
71809916|NCT00437645|143121440|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis for non-inferiority of valsartan/amlodipine 160/5 mg to amlodipine 10 mg alone with a non-inferiority margin of 3 mm Hg|Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-3.0|-0.44|||ANCOVA|||||-0.44|-3.00|
71809917|NCT03382782|143121460|SUPERIORITY||Mean Difference (Net)|0.36||||0.025|TWO_SIDED||||||ANOVA|degrees of freedom = (3, 172)||||||.025
71809918|NCT03382782|143121461|SUPERIORITY||Mean Difference (Net)|0.243||||0.784|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.784
71809919|NCT03382782|143121461|SUPERIORITY||Mean Difference (Net)|0.058||||0.81|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.810
71809920|NCT03382782|143121462|SUPERIORITY||Mean Difference (Net)|1.77||||0.174|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.174
71809921|NCT03382782|143121462|SUPERIORITY||Mean Difference (Net)|1.15||||0.286|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.286
71809922|NCT03382782|143121463|SUPERIORITY||Mean Difference (Net)|1.36||||0.261|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.261
71895361|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||||80.0|-0.28|0.57||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.57|-0.28|
71809923|NCT03382782|143121463|SUPERIORITY||Mean Difference (Net)|0.012||||0.912|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.912
71676407|NCT02397122|142870670|SUPERIORITY|||||||0.097|||||||Mann-Whitney|||6 weeks||||0.097
71676408|NCT02397122|142870670|SUPERIORITY|||||||0.07||||||\<0.05|Mann-Whitney U|||6 months||||0.070
71676409|NCT02397122|142870671|SUPERIORITY|||||||0.067|||||||Mann-Whitney|||Baseline||||0.067
71676410|NCT02397122|142870671|SUPERIORITY|||||||0.13|||||||Mann-Whitney|||6 weeks||||0.130
71676411|NCT02397122|142870671|SUPERIORITY|||||||0.128||||||\<0.05|Mann-Whitney U|||6 months||||0.128
71676412|NCT02397122|142870672|SUPERIORITY|||||||0.298|||||||Mann-Whitney|||Baseline||||0.298
71676413|NCT02397122|142870672|SUPERIORITY|||||||0.152|||||||Mann-Whitney|||6 weeks||||0.152
71676414|NCT02397122|142870672|SUPERIORITY|||||||0.317||||||\<0.05|Mann-Whitney U|||6 months||||0.317
71676415|NCT02397122|142870673|SUPERIORITY|||||||0.136|||||||Mann-Whitney|||Baseline||||0.136
71676416|NCT02397122|142870673|SUPERIORITY|||||||0.041|||||||Mann-Whitney|||6 weeks||||0.041
71676417|NCT02397122|142870673|SUPERIORITY|||||||0.064||||||\<0.05|Mann-Whitney U|||6 months||||0.064
71676418|NCT02397122|142870674|SUPERIORITY|||||||0.245|||||||Mann-Whitney|||Baseline||||0.245
71676419|NCT02397122|142870674|SUPERIORITY|||||||0.099|||||||Mann-Whitney|||6 weeks||||0.099
71809924|NCT03382782|143121465|SUPERIORITY||Mean Difference (Net)|1.74||||0.11|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 172||||||0.11
71809925|NCT03382782|143121466|SUPERIORITY||Mean Difference (Net)|1.18||||0.09|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean systolic blood pressure||||0.09
71809926|NCT03382782|143121466|SUPERIORITY||Mean Difference (Net)|0.63||||0.05|TWO_SIDED||||||ANOVA|degrees of freedom = 3, 156||Mean diastolic blood pressure||||0.05
71809927|NCT03382782|143121468|SUPERIORITY|Intention-to-treat analyses. General Health subscale.|Mean Difference (Net)|2.14||||0.121|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||||||0.121
71809928|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|1.71||||0.193|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses. General Health subscale.||||0.193
71809929|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|0.181||||0.835|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Bodily Pain subscale.||||0.835
71809930|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|0.43||||0.513|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Bodily Pain subscale.||||0.513
71809931|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|2.37||||0.097|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses, Physical Functioning subscale.||||0.097
71809932|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|0.04||||0.184|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Physical Functioning subscale.||||0.184
71809933|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|1.06||||0.347|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intention-to-treat analyses. Emotional Well-Being subscale.||||0.347
71809934|NCT03382782|143121468|SUPERIORITY||Mean Difference (Net)|0.361||||0.549|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses, Emotional Well-Being subscale.||||0.549
71809935|NCT03382782|143121469|SUPERIORITY||Mean Difference (Net)|0.157||||0.855|TWO_SIDED||||||ANOVA|Degrees of freedom = 2,182||Intention-to-treat analyses||||.855
71809936|NCT03382782|143121469|SUPERIORITY||Mean Difference (Net)|0.011||||0.915|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.915
71809937|NCT03382782|143121471|SUPERIORITY||Mean Difference (Net)|0.68||||0.508|TWO_SIDED||||||ANOVA|degrees of freedom = 2, 182||Intent-to-treat analyses||||0.508
71809938|NCT03382782|143121471|SUPERIORITY||Mean Difference (Net)|1.67||||0.198|TWO_SIDED||||||ANOVA|degrees of freedom = 1, 118||As-treated analyses||||0.198
71809939|NCT01316510|143121473|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Primary outcome (percentage of bifidobacteria in the final stool specimen)||||<0.01
71809940|NCT01316510|143121474|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)||||0.44
71809941|NCT00428090|143121475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.074|TWO_SIDED|95.0|-3.8|0.2||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.8|0.074
71809942|NCT00428090|143121475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.338|TWO_SIDED|95.0|-3.0|1.0||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.0|-3.0|0.338
71809943|NCT00428090|143121475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.602|TWO_SIDED|95.0|-3.5|2.1||Comparison between Placebo and Donepezil 10mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-3.5|0.602
71809944|NCT00428090|143121476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.131|TWO_SIDED|95.0|-2.7|0.4||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.7|0.131
71843940|NCT00112359|143202095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.453|||<|0.0001|TWO_SIDED|95.0|-2.115|-0.791||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|ANCOVA|ANCOVA model included terms for treatment and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.||-0.791|-2.115|< 0.0001
71843941|NCT00112359|143202096|SUPERIORITY_OR_OTHER|||||||0.2364||95.0||||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|Fisher Exact|Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.||||0.2364
71843942|NCT00112359|143202097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.71||||0.0005|TWO_SIDED|95.0|4.31|15.11||"Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 \>50% or \<=50% pred.). Treatment differences: AZLI-placebo.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~A sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05."||15.11|4.31|0.0005
71843943|NCT00112359|143202098|SUPERIORITY_OR_OTHER|||||||0.064||0.0||||No adjustments were made for multiple comparisons.|Fisher Exact|Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.||||0.0640
71809945|NCT00428090|143121476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.315|TWO_SIDED|95.0|-2.4|0.8||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.8|-2.4|0.315
71809946|NCT00428090|143121476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.105|TWO_SIDED|95.0|-3.5|0.3||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-3.5|0.105
71809947|NCT00428090|143121477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
71809948|NCT00428090|143121477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
71809949|NCT00428090|143121477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.4|-3.1|0.131
71809950|NCT00428090|143121478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.663|TWO_SIDED|95.0|-0.3|0.4||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-0.3|0.663
71809951|NCT00428090|143121478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.3||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.4|0.891
71809952|NCT00428090|143121478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.414|TWO_SIDED|95.0|-0.7|0.3||Comparison between Placebo and Donepezil 10 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||0.3|-0.7|0.414
71809953|NCT00428090|143121479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.3|0.3||Comparison between Placebo and RSG XR 2 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||||0.3|-0.3|0.913
71809954|NCT00428090|143121479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.276|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.276
71809955|NCT00428090|143121479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in All except e4/e4's cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.025
71809956|NCT00428090|143121480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
71809957|NCT00428090|143121480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
71809958|NCT00428090|143121480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
71843944|NCT01961609|143202100|SUPERIORITY_OR_OTHER||Percentage|65.3|||<|0.0001|TWO_SIDED|99.375|52.4|76.7|||two-sided binomial exact test||A Bonferroni adjustment adjusting for 8 analyses have been applied.|||76.7|52.4|<0.0001
71843945|NCT01988402|143202117|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5
71843946|NCT00571649|143202122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.771||||0.0211||95.0|0.618|0.962||Hochberg procedure: A 2-sided p-value of less than 0.05 would be considered significant, if the 1-sided p-value of the other primary efficacy outcome measure was less than 0.025, elsewise a p-value of less than 0.025 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (91.4% for superiority) with 4% event rate at day 35 for comparator and 40% relative risk reduction.||0.962|0.618|0.0211
71809959|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.116|TWO_SIDED|95.0|-2.0|0.2||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-2.0|0.116
71843947|NCT00571649|143202123|NON_INFERIORITY_OR_EQUIVALENCE|Rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI (Confidence Interval) was less than 1.5|Risk Ratio (RR)|0.968||||0.0025||95.0|0.713|1.314||Hochberg procedure: A 1-sided p-value of less than 0.025 would be considered significant, if the 2-sided p-value of the other primary efficacy outcome measure was less than 0.05, elsewise a p-value of less than 0.0125 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (98.6% power for non-inferiority) with 1.8% event rate at day 10 for comparator and 35% relative risk reduction.||1.314|0.713|0.0025
71809960|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.816|TWO_SIDED|95.0|-0.9|1.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.9|0.816
71676420|NCT02397122|142870674|SUPERIORITY|||||||0.077|||||||Mann-Whitney U|||||||0.077
71676421|NCT02397122|142870675|SUPERIORITY|||||||0.946|||||||Mann-Whitney|||Baseline||||0.946
71676422|NCT02397122|142870675|SUPERIORITY|||||||0.001|||||||Mann-Whitney|||6 weeks||||0.001
71809961|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.318|TWO_SIDED|95.0|-2.1|0.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.1|0.318
71809962|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.839|TWO_SIDED|95.0|-1.1|1.3||Comparison between Placebo and RSG XR 2 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.3|-1.1|0.839
71809963|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.165|TWO_SIDED|95.0|-0.3|2.0||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.0|-0.3|0.165
71809964|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.073|TWO_SIDED|95.0|-3.4|0.2||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-3.4|0.073
71809965|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.272|TWO_SIDED|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-2.2|0.272
71809966|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.297|TWO_SIDED|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-2.2|0.297
71809967|NCT00428090|143121481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.131|TWO_SIDED|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-3.1|0.131
71809968|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.133|TWO_SIDED|95.0|-0.3|0.0||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.3|0.133
71809969|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.2|0.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.2|0.958
71809970|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.085|TWO_SIDED|95.0|-0.5|0.0||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.5|0.085
71843948|NCT00571649|143202124|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.931||||0.3758||95.0|0.795|1.091||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the two primary efficacy outcome measures were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.091|0.795|0.3758
71809971|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.102|TWO_SIDED|95.0|-0.4|0.0||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.0|-0.4|0.102
71843949|NCT00571649|143202125|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.991||||0.9473||95.0|0.753|1.304||"Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the 2 primary efficacy outcomes and for Composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days were significant."|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||||1.304|0.753|0.9473
71676423|NCT02397122|142870675|SUPERIORITY|||||||0.001||||||\<0.05|Mann-Whitney U|||6 months||||0.001
71809972|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.38|TWO_SIDED|95.0|-0.3|0.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.3|0.380
71809973|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.006|TWO_SIDED|95.0|-0.7|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.7|0.006
71809974|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.939|TWO_SIDED|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-0.2|0.939
71809975|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.4|0.307
71809976|NCT00428090|143121482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.009|TWO_SIDED|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-0.8|0.009
71809977|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.957|TWO_SIDED|95.0|-1.6|1.5||Comparison between Placebo and RSG XR 2mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.5|-1.6|0.957
71813678|NCT00991341|143129667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2|TWO_SIDED|95.0|-0.82|0.17|||ANCOVA|The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.|||0.17|-0.82|0.20
71813679|NCT00991341|143129668|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.018||||0.5|TWO_SIDED|95.0|-0.033|0.069|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.069|-0.033|0.50
71813680|NCT00991341|143129669|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.027||||0.4|TWO_SIDED|95.0|-0.09|0.035|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.035|-0.090|0.40
71813681|NCT00991341|143129670|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.018||||0.41|TWO_SIDED|95.0|-0.059|0.023|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.023|-0.059|0.41
71813682|NCT00991341|143129671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.75|TWO_SIDED|95.0|-0.62|0.37|||Kruskal-Wallis|||||0.37|-0.62|0.75
71813683|NCT00991341|143129672|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.62|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.|||0.05|-0.08|0.62
71813684|NCT00991341|143129673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.93||||0.35|TWO_SIDED|95.0|-2.11|5.98||The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.|ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.|Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.||5.98|-2.11|0.35
71813685|NCT00991341|143129674|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Kruskal-Wallis|||||||0.10
71813686|NCT00991341|143129675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|||<|0.01|TWO_SIDED|95.0|-0.89|-0.41|||ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.|||-0.41|-0.89|<0.01
71813687|NCT00991341|143129677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.98|1.25||The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.|Regression, Cox||The longer storage duration arm is reference category.|||1.25|0.98|0.11
71813688|NCT00991341|143129678|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.22|TWO_SIDED|95.0|0.96|1.22|||Regression, Cox|The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.|The longer storage duration arm is reference category.|||1.22|0.96|0.22
71809978|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.693|TWO_SIDED|95.0|-1.4|2.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-1.4|0.693
71809979|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.798|TWO_SIDED|95.0|-2.2|1.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.7|-2.2|0.798
71809980|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-1.7|1.8||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|-1.7|0.958
71676424|NCT05831644|142870676|SUPERIORITY||Mean Difference (Final Values)|-0.124||||0.1925|TWO_SIDED|90.0|-0.285|0.037|||ANOVA|||The primary endpoint (RHI score) was compared between treatments using an analysis of variance model (ANOVA) with treatment and period as fixed effects and subjects as random effect.||0.037|-0.285|0.1925
71809981|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-2.1|2.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.1|-2.1|0.998
71809982|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.639||95.0|-1.7|2.8||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-1.7|0.639
71809983|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.797|TWO_SIDED|95.0|-2.1|2.7||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.1|0.797
71809984|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.942|TWO_SIDED|95.0|-2.9|2.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.7|-2.9|0.942
71809985|NCT00428090|143121483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.213|TWO_SIDED|95.0|-4.8|1.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-4.8|0.213
71809986|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.919|TWO_SIDED|95.0|-2.1|2.3||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.3|-2.1|0.919
71809987|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.649|TWO_SIDED|95.0|-1.5|2.4||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.4|-1.5|0.649
71809988|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.279|TWO_SIDED|95.0|-1.1|3.6||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.1|0.279
71809989|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.498|TWO_SIDED|95.0|-1.8|3.6||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.8|0.498
71843950|NCT00571649|143202134|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.455|||<|0.0001|TWO_SIDED|95.0|1.854|3.251||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||There was no sample size estimation as this was not planed as confirmatory analysis||3.251|1.854|<0.0001
71843951|NCT00571649|143202135|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.272|||<|0.0001|TWO_SIDED|95.0|1.628|3.171||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|||There was no sample size estimation as this was not planed as confirmatory analysis||3.171|1.628|<0.0001
71843952|NCT03983434|143202143|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.62|||||||Kruskal-Wallis|||||||.62
71843953|NCT03983434|143202144|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
71843954|NCT03983434|143202145|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.17|||||||Kruskal-Wallis|||||||0.17
71809990|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.489|TWO_SIDED|95.0|-1.7|3.6||Comparison between Placebo and RSG XR 8 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.6|-1.7|0.489
71843955|NCT03983434|143202146|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.079|||||||Kruskal-Wallis|||||||0.079
71843956|NCT03983434|143202147|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.47|||||||Kruskal-Wallis|||||||0.47
71676425|NCT05831644|142870677|SUPERIORITY||Mean Difference (Final Values)|-4.94||||0.1941|TWO_SIDED|90.0|-11.392|1.513|||ANOVA|||The secondary pharmacodynamic endpoint (AI) was analysed using a similar ANOVA model as for the primary endpoint.||1.513|-11.392|0.1941
71809991|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.024|TWO_SIDED|95.0|0.5|7.0||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.0|0.5|0.024
71809992|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.385|TWO_SIDED|95.0|-1.6|4.2||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||4.2|-1.6|0.385
71809993|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.944|TWO_SIDED|95.0|-3.0|2.8||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.8|-3.0|0.944
71809994|NCT00428090|143121484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.078|TWO_SIDED|95.0|-0.4|7.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||7.5|-0.4|0.078
71809995|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.635|TWO_SIDED|95.0|-0.8|0.5||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-0.8|0.635
71809996|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.194|TWO_SIDED|95.0|-0.2|1.1||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-0.2|0.194
71809997|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.325|TWO_SIDED|95.0|-1.3|0.4||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-1.3|0.325
71809998|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.109|TWO_SIDED|95.0|-0.1|1.2||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-0.1|0.109
71809999|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.032|TWO_SIDED|95.0|0.1|1.4||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|0.1|0.032
71810000|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.189|TWO_SIDED|95.0|-1.7|0.3||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.7|0.189
71810001|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.288|TWO_SIDED|95.0|-1.1|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.3|-1.1|0.288
71843957|NCT03983434|143202149|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.03|||||||Kruskal-Wallis|||||||0.03
71843958|NCT03983434|143202150|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.14|||||||Kruskal-Wallis|||||||0.14
71843959|NCT03983434|143202151|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.074|||||||Kruskal-Wallis|||||||0.074
71843960|NCT03983434|143202152|OTHER|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71843961|NCT03983434|143202153|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
71676426|NCT02703467|142870695|SUPERIORITY||||||>|0.05||||||calculated|t-test, 2 sided|||||||>0.05
71810002|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.819|TWO_SIDED|95.0|-0.8|0.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.819
71810003|NCT00428090|143121485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.306|TWO_SIDED|95.0|-1.5|0.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.5|0.306
71843962|NCT03983434|143202154|OTHER|Due to the skewness of the data, outcome measures were summarized using median and interquartile range.||||||0.98|||||||Kruskal-Wallis|||||||0.98
71843963|NCT01324310|143202209|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geometric Mean|124.4|||||TWO_SIDED|90.0|110.2|140.5|||ANOVA||"Geometric means ratio (Romidepsin + Ketoconazole/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||140.5|110.2|
71843964|NCT01324310|143202210|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|123.7|||||TWO_SIDED|90.0|109.6|139.6|||ANOVA|||||139.6|109.6|
71843965|NCT01324310|143202211|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|124.6|||||TWO_SIDED|90.0|109.0|142.4|||ANOVA|||||142.4|109.0|
71843966|NCT01324310|143202212|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|109.5|||||TWO_SIDED|90.0|94.9|126.4|||ANOVA|||||126.4|94.9|
71843967|NCT01324310|143202213|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0||||0.7422|TWO_SIDED|90.0|-0.485|0.095|||Wilcoxon signed- rank|||"Note: The median, median difference (romidepsin + ketoconazole minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||0.095|-0.485|0.7422
71843968|NCT04027439|143202228|OTHER||Contrast Ratio|1.186|||<|0.0001|TWO_SIDED|95.0|1.138|1.235|||ANCOVA|||||1.235|1.138|<0.0001
71843969|NCT04027439|143202228|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.088|1.181|||ANCOVA|||||1.181|1.088|<0.0001
71843970|NCT04027439|143202228|OTHER||Contrast Ratio|1.134|||<|0.0001|TWO_SIDED|95.0|1.089|1.181|||ANCOVA|||||1.181|1.089|<0.0001
71843971|NCT04027439|143202228|OTHER||Contrast Ratio|1.084||||0.0001|TWO_SIDED|95.0|1.041|1.128|||ANCOVA|||||1.128|1.041|0.0001
71843972|NCT04027439|143202229|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.105|1.365|||ANCOVA|||||1.365|1.105|0.0004
71676427|NCT03010800|142870700|SUPERIORITY|||||||0.0469||||||One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.|Wilcoxon (Mann-Whitney)|||"Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.~A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected."||||0.0469
71676428|NCT03386994|142870704|OTHER|||||||0.0002|||||||ANOVA|Total annual IPF-related costs||||||0.0002
71676429|NCT03386994|142870704|OTHER|||||||0.0007|||||||ANOVA|Annual direct health IPF-related costs||||||0.0007
71676430|NCT03386994|142870704|OTHER||||||<|0.0001|||||||ANOVA|Annual direct non-health IPF-related costs||||||<0.0001
71810004|NCT00428090|143121486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.199|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.199
71810005|NCT00428090|143121486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.094|TWO_SIDED|95.0|-0.01|0.08||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.08|-0.01|0.094
71810006|NCT00428090|143121486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.187|TWO_SIDED|95.0|-0.02|0.09||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.09|-0.02|0.187
71810007|NCT00428090|143121486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.134|TWO_SIDED|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.01|0.134
71810008|NCT00428090|143121486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.05|0.05||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.05|-0.05|0.958
71676431|NCT03386994|142870704|OTHER|||||||0.6839|||||||ANOVA|Annual indirect IPF-related costs||||||0.6839
71676432|NCT03386994|142870705|OTHER|||||||0.002|||||||Kruskal-Wallis|Timepoint: T0||||||0.0020
71810009|NCT00428090|143121486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.374|TWO_SIDED|95.0|-0.03|0.07||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.07|-0.03|0.374
71843973|NCT04027439|143202229|OTHER||Contrast Ratio|1.228||||0.0004|TWO_SIDED|95.0|1.104|1.365|||ANCOVA|||||1.365|1.104|0.0004
71676433|NCT03386994|142870705|OTHER|||||||0.1385|||||||Kruskal-Wallis|Timepoint: T6||||||0.1385
71676434|NCT03386994|142870705|OTHER|||||||0.0233|||||||Kruskal-Wallis|Timepoint: T12||||||0.0233
71676435|NCT03386994|142870706|OTHER|||||||0.156||||||Timepoint: T0|Kruskal-Wallis|||||||0.1560
71676436|NCT03386994|142870706|OTHER|||||||0.3144||||||Timepoint: T6|Kruskal-Wallis|||||||0.3144
71676437|NCT03386994|142870706|OTHER|||||||0.2019||||||Timepoint: T12|Kruskal-Wallis|||||||0.2019
71676438|NCT03386994|142870707|OTHER|||||||0.0075||||||Timepoint: T0|Kruskal-Wallis|||||||0.0075
71676439|NCT03386994|142870707|OTHER|||||||0.0361||||||Timepoint: T6|Kruskal-Wallis|||||||0.0361
71676440|NCT03386994|142870707|OTHER|||||||0.4794||||||Timepoint: T12|Kruskal-Wallis|||||||0.4794
71676441|NCT03386994|142870708|OTHER|||||||0.0333|||||||Fisher Exact|||||||0.0333
71676442|NCT03386994|142870710|OTHER|||||||0.4711|||||||ANOVA|Total annual IPF-related costs||||||0.4711
71676443|NCT03386994|142870710|OTHER|||||||0.4095|||||||ANOVA|Annual direct health IPF-related costs||||||0.4095
71676444|NCT03386994|142870710|OTHER|||||||0.0435|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0435
71676445|NCT03386994|142870710|OTHER|||||||0.5479|||||||ANOVA|Annual indirect IPF-related costs||||||0.5479
71676446|NCT03386994|142870712|OTHER|||||||0.7486|||||||ANOVA|Total annual IPF-related costs||||||0.7486
71676447|NCT03386994|142870712|OTHER|||||||0.7652|||||||ANOVA|Annual direct health IPF-related costs||||||0.7652
71676448|NCT03386994|142870712|OTHER|||||||0.0037|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.0037
71676449|NCT03386994|142870712|OTHER|||||||0.6119|||||||ANOVA|Annual indirect IPF-related costs||||||0.6119
71676450|NCT03386994|142870713|OTHER|||||||0.1581|||||||ANOVA|Total annual IPF-related costs||||||0.1581
71676451|NCT03386994|142870713|OTHER|||||||0.1581|||||||ANOVA|Annual direct health IPF-related costs||||||0.1581
71676452|NCT03386994|142870713|OTHER|||||||0.7165|||||||ANOVA|Annual direct non-health IPF-related costs||||||0.7165
71676453|NCT03386994|142870713|OTHER|||||||1|||||||ANOVA|Annual indirect IPF-related costs||||||1.0000
71676454|NCT03386994|142870714|OTHER|||||||0.0733|||||||Kruskal-Wallis|||||||0.0733
71676455|NCT03386994|142870716|OTHER|||||||0.0207|||||||Kruskal-Wallis|||||||0.0207
71676456|NCT03386994|142870717|OTHER|||||||0.0942|||||||Kruskal-Wallis|||||||0.0942
71676457|NCT03386994|142870718|OTHER|||||||0.0747|||||||Kruskal-Wallis|||||||0.0747
71676458|NCT03386994|142870720|OTHER|||||||0.1282|||||||Kruskal-Wallis|||||||0.1282
71676459|NCT03386994|142870721|OTHER|||||||0.7471|||||||Kruskal-Wallis|||||||0.7471
71843974|NCT04027439|143202229|OTHER||Contrast Ratio|1.196||||0.0012|TWO_SIDED|95.0|1.08|1.326|||ANCOVA|||||1.326|1.080|0.0012
71843975|NCT04027439|143202229|OTHER||Contrast Ratio|1.121||||0.0348|TWO_SIDED|95.0|1.009|1.246|||ANCOVA|||||1.246|1.009|0.0348
71810010|NCT00428090|143121487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.493|TWO_SIDED|95.0|-4.6|2.2||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.2|-4.6|0.493
71810011|NCT00428090|143121487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.883|TWO_SIDED|95.0|-3.2|3.7||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||3.7|-3.2|0.883
71810012|NCT00428090|143121487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.13|TWO_SIDED|95.0|-9.3|1.2||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.2|-9.3|0.130
71810013|NCT00428090|143121487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.198|TWO_SIDED|95.0|-6.6|1.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.4|-6.6|0.198
71810014|NCT00428090|143121487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.441|TWO_SIDED|95.0|-5.9|2.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||2.6|-5.9|0.441
71810015|NCT00428090|143121487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.898|TWO_SIDED|95.0|-5.8|5.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||5.1|-5.8|0.898
71810016|NCT00428090|143121489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.027|TWO_SIDED|95.0|-2.1|-0.1||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||-0.1|-2.1|0.027
71810017|NCT00428090|143121489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.278|TWO_SIDED|95.0|-1.6|0.5||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.5|-1.6|0.278
71810018|NCT00428090|143121489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-1.2|1.1||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.1|-1.2|0.993
71843976|NCT04027439|143202229|OTHER||Contrast Ratio|1.055||||0.3106|TWO_SIDED|95.0|0.949|1.172|||ANCOVA|||||1.172|0.949|0.3106
71843977|NCT04027439|143202230|OTHER||Contrast Ratio|1.154||||0.0208|TWO_SIDED|95.0|1.024|1.301|||ANCOVA|||||1.301|1.024|0.0208
71810019|NCT00428090|143121489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.196|TWO_SIDED|95.0|-2.0|0.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.4|-2.0|0.196
71810020|NCT00428090|143121489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.353|TWO_SIDED|95.0|-1.9|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.7|-1.9|0.353
71810021|NCT00428090|143121489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.427|TWO_SIDED|95.0|-2.2|0.9||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.9|-2.2|0.427
71810022|NCT00428090|143121490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.886|TWO_SIDED|95.0|-0.7|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.7|0.886
71843978|NCT04027439|143202230|OTHER||Contrast Ratio|1.2||||0.0041|TWO_SIDED|95.0|1.064|1.353|||ANCOVA|||||1.353|1.064|0.0041
71843979|NCT04027439|143202230|OTHER||Contrast Ratio|1.167||||0.0108|TWO_SIDED|95.0|1.039|1.311|||ANCOVA|||||1.311|1.039|0.0108
71843980|NCT04027439|143202230|OTHER||Contrast Ratio|1.087||||0.1641|TWO_SIDED|95.0|0.965|1.225|||ANCOVA|||||1.225|0.965|0.1641
71843981|NCT04027439|143202231|OTHER||Contrast Ratio|1.229||||0.0005|TWO_SIDED|95.0|1.102|1.369|||ANCOVA|||||1.369|1.102|0.0005
71676460|NCT00877487|142870743|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.23|||<|0.0001|TWO_SIDED|95.0|-19.1|-11.4|||ANCOVA|||||-11.4|-19.1|<0.0001
71676461|NCT00877487|142870744|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71810023|NCT00428090|143121490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.71|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.6|-0.8|0.710
71810024|NCT00428090|143121490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.03|TWO_SIDED|95.0|0.1|1.8|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||1.8|0.1|0.030
71810025|NCT00428090|143121491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.139|TWO_SIDED|95.0|0.0|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.0|0.139
71810026|NCT00428090|143121491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.846|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.1|-0.1|0.846
71810027|NCT00428090|143121491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data|||0.2|-0.1|0.864
71810028|NCT00361140|143121502|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Chi-squared|||||||.007
71810029|NCT00361140|143121503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.27||||0.07|TWO_SIDED|95.0|0.92|42.48|||Gray|Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.||Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)||42.48|0.92|.07
71810030|NCT05159622|143121521|EQUIVALENCE|A net effect of 6 fluid oz/day (SD=1) was hypothesized among adult parents, assuming two sided alpha=0.05, power = 80%, and a minimum sample size of 60 adults.|Median Difference (Final Values)|3.2||||0.15|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05. P-value of the interaction between treatment group and change in beverage consumption (fl oz/day).|t-test, 2 sided|||||||0.15
71810031|NCT05159622|143121522|EQUIVALENCE|This was an exploratory outcome.|Median Difference (Final Values)|0.07||||0.98|TWO_SIDED||||||t-test, 2 sided|||||||0.98
71810032|NCT05159622|143121523|EQUIVALENCE|This was an exploratory outcome and therefore statistical power was not based on a hypothesis of this outcome.|Median Difference (Final Values)|0.64||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
71810033|NCT05159622|143121524|EQUIVALENCE|Exploratory outcome as for infants/toddlers based on parent-report|Median Difference (Final Values)|0.14||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
71810034|NCT05159622|143121525|EQUIVALENCE|Exploratory outcome|Median Difference (Final Values)|0.95||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71810035|NCT03384173|143121531|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71676462|NCT00877487|142870745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71810036|NCT03384173|143121532|OTHER|Correlation, Pearson r|Pearson r correlation|0.16||||0.17|TWO_SIDED|95.0|-0.07|0.37|||Pearson r correlation|||||0.37|-0.07|0.17
71810037|NCT03384173|143121533|OTHER|Correlation, Pearson r|Pearson r correlation|0.12||||0.32|TWO_SIDED|95.0|-0.11|0.33|||Pearson r correlation|||||0.33|-0.11|0.32
71810038|NCT03384173|143121535|OTHER|Mann Whitney U non parametric test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup 30-39.99%' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Control group is Secondary analysis #4, baseline values before caffeine dose.||||<0.01
71810039|NCT03384173|143121536|OTHER|Mann Whitney U non parametric test|||||<|0.001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Control group is secondary outcome #4, baseline values before caffeine dose||||<0.001
71810040|NCT03384173|143121537|OTHER|Mann-Whitney U non parametric t test|||||<|0.01||||||"A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.~A-priori threshold p\<0.05 for 'subgroup \>60% ' vs 'baseline value before caffeine dose'."|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary outcome #4, baseline caffeine values by subgroup||||<0.01
71813689|NCT00991341|143129679|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.71|TWO_SIDED|95.0|-0.59|1.0|||Kruskal-Wallis||The longer storage duration arm is reference category.|||1.00|-0.59|0.71
71813690|NCT00991341|143129680|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.53|TWO_SIDED|95.0|-0.057|0.027|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.|||0.027|-0.057|0.53
71813691|NCT00215540|143129713|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.476
71813692|NCT00215540|143129713|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.208
71813693|NCT00215540|143129714|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.500
71813694|NCT00215540|143129714|SUPERIORITY_OR_OTHER|||||||0.146||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups||||0.146
71813695|NCT00215540|143129715|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
71813696|NCT00215540|143129715|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
71813697|NCT00215540|143129715|SUPERIORITY_OR_OTHER|||||||0.944||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.944
71676463|NCT02729051|142870752|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.|Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.0161|||TWO_SIDED|95.0|-0.013|0.05|||||MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.|||0.050|-0.013|
71810041|NCT03384173|143121538|OTHER||||||<|0.0001||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is secondary outcome #4, baseline values before caffeine dose||||<0.0001
71676464|NCT02729051|142870753|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.71|1.2|||||Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.|||1.20|0.71|
71810042|NCT03384173|143121539|OTHER|Mann Whitney U non-parametric t-test|||||<|0.05||||||A-priori threshold p\<0.05 for 'subgroup 20-29.99%' vs 'baseline value before caffeine dose'.|Wilcoxon (Mann-Whitney)|||Comparison group is Secondary Outcome #4, baseline before dose of caffeine.||||<0.05
71810043|NCT00863655|143121540|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Log Rank|||||0.54|0.35|<0.0001
71810044|NCT02157779|143121552|SUPERIORITY||Least Squares Mean Difference|-5.68||||0.017|TWO_SIDED|95.0|-10.32|-1.01||Threshold for statistical significance was 0.025.|ANCOVA|Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the HLM analyses.||-1.01|-10.32|.017
71810045|NCT02157779|143121553|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.19|TWO_SIDED|95.0|-0.33|0.06||The threshold for statistical significance was p=0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||Population Description: All randomized participants with at least one post-baseline assessment (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were used in the statistical analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|0.06|-0.33|0.19
71810046|NCT02157779|143121554|SUPERIORITY||Least Squares Mean Difference|-0.42||||0.011|TWO_SIDED|95.0|-0.75|-0.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|-0.09|-0.75|.011
71810047|NCT02157779|143121555|SUPERIORITY||Least Squares Mean Difference|-0.26||||0.16|TWO_SIDED|95.0|-0.63|0.11||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment, 3 month and/or 6 month follow-up) were included in the analyses.||0.11|-0.63|0.16
71810048|NCT02157779|143121556|SUPERIORITY||Least Squares Mean Difference|-11.65||||0.031|TWO_SIDED|95.0|-22.2|-1.09||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (12 weeks (end of treatment), 3 month and/or 6 month follow-up) were included in the statistical analyses.||-1.09|-22.20|.031
71810049|NCT02157779|143121557|SUPERIORITY||Least Squares Mean Difference|1.56||||0.004|TWO_SIDED|95.0|0.51|2.6||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.||All randomized participants with at least one post-baseline assessment (week 12 (end of treatment), 3 month, and/or 6 month follow-up) were used in the statistical analysis.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|2.60|0.51|0.004
71810050|NCT02157779|143121558|SUPERIORITY||Least Squares Mean Difference|-2.15||||0.416|TWO_SIDED|95.0|-7.37|3.07||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI|All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.||3.07|-7.37|0.416
71810051|NCT02157779|143121559|SUPERIORITY||Least Squares Mean Difference|-13.72||||0.028|TWO_SIDED|95.0|-25.94|-1.5||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the analyses.||-1.50|-25.94|0.028
71810052|NCT02157779|143121560|SUPERIORITY|||||||0.13|||||||ANOVA|GLM Repeated Measures Analysis of Variance of means grouped by sessions 1-4, 5-8, and 9-12||All randomized participants with at least one DAR completed in each time frame (sessions 1-4, 5-8, and 9-12) were included in the analyses. The mean DAR scores for sessions 1-4, 5-8, and 9-12 were calculated and used as outcome variables in the GLM repeated measures ANOVA.||||0.13
71810053|NCT02157779|143121561|SUPERIORITY||Least Squares Mean Difference|-0.82||||0.03|TWO_SIDED|95.0|-1.578|-0.063||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (week 4, week 8, week 12 (end of treatment), 3 mo and/or 6 month follow-up) were included in the HLM analyses.||-0.063|-1.578|0.030
71810054|NCT02157779|143121562|SUPERIORITY||Least Squares Mean Difference|-0.085||||0.021|TWO_SIDED|95.0|-0.158|-0.011||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||-0.011|-0.158|0.021
71810055|NCT02157779|143121563|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.246|TWO_SIDED|95.0|-0.283|0.073||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were used in the HLM analysis. Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data.||0.073|-0.283|0.246
71810056|NCT02157779|143121564|SUPERIORITY||Least Squares Mean Difference|-0.14||||0.036|TWO_SIDED|95.0|-0.27|-0.01||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment were used in the statistical analysis. Data were winsorized and log 10 transformed to counter high levels of skewness.||-0.01|-0.27|0.036
71813698|NCT00215540|143129716|SUPERIORITY_OR_OTHER|||||||0.476||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.476
71813699|NCT00215540|143129716|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.208
71813700|NCT00215540|143129716|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.046
71813701|NCT00215540|143129717|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.285
71813702|NCT00215540|143129717|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.229
71813703|NCT00215540|143129717|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.030
71813704|NCT00215540|143129718|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.483
71813705|NCT00215540|143129718|SUPERIORITY_OR_OTHER|||||||0.123||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.123
71813706|NCT00215540|143129718|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.006
71813707|NCT00215540|143129719|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|Adjusting for pooled study center||||||0.843
71813708|NCT00215540|143129719|SUPERIORITY_OR_OTHER|||||||0.543||95.0|||||ANOVA|Adjusting for pooled study center||||||0.543
71676465|NCT02729051|142870754|OTHER||Least Square Mean Difference|-0.906|STANDARD_ERROR_OF_MEAN|0.8327|||TWO_SIDED|95.0|-2.54|0.728|||||Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.|||0.728|-2.540|
71810057|NCT02157779|143121565|SUPERIORITY||Least Squares Mean Difference|-0.026||||0.786|TWO_SIDED|95.0|-0.213|0.1614||Threshold for statistical significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.1614|-0.213|0.786
71810058|NCT02157779|143121566|SUPERIORITY||Least Squares Mean Difference|-0.02||||0.744|TWO_SIDED|95.0|-0.18|0.13||Threshold for significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis.~Data were winsorized and log10 transformed to counter high levels of skewness. Full Information Maximum Likelihood was used to account for missing data."||0.13|-0.18|0.744
71810059|NCT02157779|143121567|SUPERIORITY||Least Squares Mean Difference|-1.85||||0.002|TWO_SIDED|95.0|-3.038|-0.663||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4 week, 8 week, 12 week, 3 month and/or 6 month follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||-0.663|-3.038|0.002
71810060|NCT02157779|143121568|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.186|TWO_SIDED|95.0|-2.518|0.524||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis. Full Information Maximum Likelihood was used to account for missing data.||0.524|-2.518|0.186
71810061|NCT02157779|143121569|SUPERIORITY||Least Squares Mean Difference|1.26||||0.164|TWO_SIDED|95.0|-0.56|3.09||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||3.09|-0.560|0.164
71676466|NCT02729051|142870755|OTHER||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.72|1.25|||||Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.|||1.25|0.72|
71810062|NCT02157779|143121570|SUPERIORITY||Least Squares Mean Difference|1.33||||0.1|TWO_SIDED|95.0|-0.26|2.92||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|A positive difference means that the adjusted mean for CBI is numerically higher than that for SI.|"All randomized participants with at least one post-baseline assessment (4wk, 8wk, 12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||2.92|-0.26|0.100
71813709|NCT00215540|143129719|SUPERIORITY_OR_OTHER|||||||0.537||95.0|||||ANOVA|Adjusting for pooled study center||||||0.537
71813710|NCT00215540|143129720|SUPERIORITY_OR_OTHER|||||||0.813||95.0|||||ANOVA|Adjusting for pooled study center||||||0.813
71813711|NCT00215540|143129720|SUPERIORITY_OR_OTHER|||||||0.449||95.0|||||ANOVA|Adjusting for pooled study center||||||0.449
71813712|NCT00215540|143129720|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||ANOVA|Adjusting for pooled study center||||||0.275
71813713|NCT00215540|143129721|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.267
71813714|NCT00215540|143129721|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||||||0.313
71810063|NCT02157779|143121571|SUPERIORITY||Least Squares Mean Difference|-6.29||||0.06|TWO_SIDED|95.0|-12.85|0.27||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.||"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI, indicating less symptomatic distress.|0.27|-12.85|0.060
71810064|NCT02157779|143121572|SUPERIORITY||Least Squares Mean Difference|-3.271||||0.023|TWO_SIDED|95.0|-6.083|-0.458||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||-0.458|-6.083|0.023
71810065|NCT02157779|143121573|SUPERIORITY||Least Squares Mean Difference|-1.28||||0.23|TWO_SIDED|95.0|-3.39|0.82||Threshold for significance was 0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, controlling for baseline score.|A negative difference means that the adjusted mean for CBI is numerically lower than that for SI.|"All randomized participants with at least one post-baseline assessment (12 week (end of treatment), 3 mo and/or 6 mo follow-up) were included in the HLM analysis.~Full Information Maximum Likelihood was used to account for missing data."||0.82|-3.39|0.23
71810066|NCT00430248|143121577|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.|Difference in percentage|3.1||||||95.0|-1.9|8.1||||||The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.||8.1|-1.9|
71810067|NCT00430248|143121577|SUPERIORITY_OR_OTHER|||||||0.233||95.0||||The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||||0.233
71810068|NCT00430248|143121577|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||<|0.001||95.0|20.1|29.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||29.8|20.1|<0.001
71810069|NCT00430248|143121577|SUPERIORITY_OR_OTHER||Difference in percentage|21.9|||<|0.001||95.0|17.0|26.8||Comparisons between treatment groups were performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact|||||26.8|17.0|<0.001
71810070|NCT00430248|143121578|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.021
71810071|NCT00430248|143121578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810072|NCT00430248|143121578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71843982|NCT04027439|143202231|OTHER||Contrast Ratio|1.231||||0.0005|TWO_SIDED|95.0|1.104|1.372|||ANCOVA|||||1.372|1.104|0.0005
71810073|NCT00430248|143121579|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.031
71810074|NCT00430248|143121579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810075|NCT00430248|143121579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810076|NCT00430248|143121580|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.578
71810077|NCT00430248|143121580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810078|NCT00430248|143121580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71843983|NCT04027439|143202231|OTHER||Contrast Ratio|1.188||||0.0022|TWO_SIDED|95.0|1.07|1.32|||ANCOVA|||||1.320|1.070|0.0022
71843984|NCT04027439|143202231|OTHER||Contrast Ratio|1.106||||0.0658|TWO_SIDED|95.0|0.993|1.233|||ANCOVA|||||1.233|0.993|0.0658
71843985|NCT04027439|143202239|OTHER||Contrast Ratio|1.183|||<|0.0001|TWO_SIDED|95.0|1.134|1.234|||ANCOVA|||||1.234|1.134|<0.0001
71843986|NCT04027439|143202239|OTHER||Contrast Ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.092|1.19|||ANCOVA|||||1.190|1.092|<0.0001
71810079|NCT00430248|143121581|SUPERIORITY_OR_OTHER|||||||0.426||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.426
71810080|NCT00430248|143121581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810081|NCT00430248|143121581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810082|NCT00430248|143121582|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.050
71810083|NCT00430248|143121582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810084|NCT00430248|143121582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810085|NCT00430248|143121583|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.428
71810086|NCT00430248|143121583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810087|NCT00430248|143121583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810088|NCT00430248|143121584|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.041
71810089|NCT00430248|143121584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810090|NCT00430248|143121584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810091|NCT00430248|143121585|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.083
71843987|NCT04027439|143202239|OTHER||Contrast Ratio|1.131|||<|0.0001|TWO_SIDED|95.0|1.084|1.18|||ANCOVA|||||1.180|1.084|<0.0001
71843988|NCT04027439|143202239|OTHER||Contrast Ratio|1.08||||0.0004|TWO_SIDED|95.0|1.036|1.126|||ANCOVA|||||1.126|1.036|0.0004
71843989|NCT04027439|143202240|OTHER||Contrast Ratio|1.123|||<|0.0001|TWO_SIDED|95.0|1.078|1.169|||ANCOVA|||||1.169|1.078|<0.0001
71895362|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|||||TWO_SIDED|80.0|0.19|1.11||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||1.11|0.19|
71895363|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.36|||||TWO_SIDED|80.0|0.03|0.68||||||Compared with Baseline (Pre-dinner)||0.68|0.03|
71810092|NCT00430248|143121585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810093|NCT00430248|143121585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71895364|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|80.0|-0.08|0.67||||||Compared with Baseline (Pre-dinner)||0.67|-0.08|
71895365|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|80.0|-0.05|0.68||||||Compared with Baseline (Pre-dinner)||0.68|-0.05|
71895366|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|||||TWO_SIDED|80.0|-0.45|0.53||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.53|-0.45|
71895367|NCT01933672|143313083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|80.0|-0.55|0.51||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.51|-0.55|
71895368|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|||||TWO_SIDED|80.0|-0.75|1.07||||||Compared with Baseline （Pre-breakfast）||1.07|-0.75|
71810094|NCT00430248|143121586|SUPERIORITY_OR_OTHER|||||||0.421||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.421
71843990|NCT04027439|143202240|OTHER||Contrast Ratio|1.078||||0.0004|TWO_SIDED|95.0|1.035|1.122|||ANCOVA|||||1.122|1.035|0.0004
71843991|NCT04027439|143202240|OTHER||Contrast Ratio|1.081||||0.0002|TWO_SIDED|95.0|1.039|1.125|||ANCOVA|||||1.125|1.039|0.0002
71843992|NCT04027439|143202240|OTHER||Contrast Ratio|1.041||||0.0437|TWO_SIDED|95.0|1.001|1.083|||ANCOVA|||||1.083|1.001|0.0437
71843993|NCT04027439|143202241|OTHER||Contrast Ratio|1.087||||0.0006|TWO_SIDED|95.0|1.038|1.139|||ANCOVA|||||1.139|1.038|0.0006
71843994|NCT04027439|143202241|OTHER||Contrast Ratio|1.083||||0.001|TWO_SIDED|95.0|1.034|1.135|||ANCOVA|||||1.135|1.034|0.0010
71843995|NCT04027439|143202241|OTHER||Contrast Ratio|1.096||||0.0002|TWO_SIDED|95.0|1.047|1.149|||ANCOVA|||||1.149|1.047|0.0002
71843996|NCT04027439|143202241|OTHER||Contrast Ratio|1.039||||0.0971|TWO_SIDED|95.0|0.993|1.088|||ANCOVA|||||1.088|0.993|0.0971
71843997|NCT04027439|143202242|OTHER||Contrast Ratio|1.145|||<|0.0001|TWO_SIDED|95.0|1.106|1.185|||ANCOVA|||||1.185|1.106|<0.0001
71843998|NCT04027439|143202242|OTHER||Contrast Ratio|1.148|||<|0.0001|TWO_SIDED|95.0|1.109|1.189|||ANCOVA|||||1.189|1.109|<0.0001
71843999|NCT04027439|143202242|OTHER||Contrast Ratio|1.099|||<|0.0001|TWO_SIDED|95.0|1.062|1.137|||ANCOVA|||||1.137|1.062|<0.0001
71895369|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|80.0|-0.58|1.51||||||Compared with Baseline (Pre-breakfast)||1.51|-0.58|
71895370|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|80.0|0.58|2.63||||||Compared with Baseline (Pre-breakfast)||2.63|0.58|
71895371|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|||||TWO_SIDED|80.0|-2.84|-0.05||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||-0.05|-2.84|
71895372|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.14|||||TWO_SIDED|80.0|-2.63|0.35||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.35|-2.63|
71810095|NCT00430248|143121586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810096|NCT00430248|143121586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810097|NCT00430248|143121587|SUPERIORITY_OR_OTHER|||||||0.52||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.520
71810098|NCT00430248|143121587|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810099|NCT00430248|143121587|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71676467|NCT02729051|142870756|OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.1773|||TWO_SIDED|95.0|-0.211|0.485|||||Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.|||0.485|-0.211|
71810100|NCT00430248|143121588|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.195
71810101|NCT00430248|143121588|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810102|NCT00430248|143121588|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810103|NCT00430248|143121589|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||0.196
71810104|NCT00430248|143121589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810105|NCT00430248|143121589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact|||||||<0.001
71810106|NCT00430248|143121590|SUPERIORITY_OR_OTHER|||||||0.079||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.079
71810107|NCT00430248|143121590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810108|NCT00430248|143121590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810109|NCT00430248|143121591|SUPERIORITY_OR_OTHER|||||||0.685||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.685
71810110|NCT00430248|143121591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810111|NCT00430248|143121591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810112|NCT00430248|143121592|SUPERIORITY_OR_OTHER|||||||0.153||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.153
71810113|NCT00430248|143121592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810114|NCT00430248|143121592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810115|NCT00430248|143121593|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||0.050
71810116|NCT00430248|143121593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810117|NCT00430248|143121593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA|||||||<0.001
71810118|NCT02249819|143121594|EQUIVALENCE|Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).||||||0.694||||||The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).|wilcoxon sign-ranked test|Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.||||||0.694
71813715|NCT00215540|143129722|SUPERIORITY_OR_OTHER|||||||0.311||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.311
71813716|NCT00215540|143129722|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.516
71813717|NCT00215540|143129722|SUPERIORITY_OR_OTHER|||||||0.094||95.0|||||ANOVA|On rank adjusting for pooled study center||||||0.094
71813718|NCT03010462|143129723|SUPERIORITY|||||||0.62|||||||Chi-squared, Corrected|||||||0.62
71813719|NCT03010462|143129724|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71813720|NCT03010462|143129725|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71813721|NCT03010462|143129726|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
71813722|NCT03010462|143129727|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
71813723|NCT00246337|143129729|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%||||0.015
71813724|NCT00246337|143129730|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
71813725|NCT00246337|143129731|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
71813726|NCT00246337|143129732|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.||||<0.001
71813727|NCT00431184|143129733|SUPERIORITY_OR_OTHER|||||||0.22|||||||Mixed Models Analysis|||||||0.22
71810119|NCT01274182|143121621|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.106|||||TWO_SIDED|90.0|1.01|1.21|||||GP2013 arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.210|1.010|
71810120|NCT01274182|143121621|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.012|||||TWO_SIDED|90.0|0.925|1.108|||||GP2013 arm is the numerator and Rituxan arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.108|0.925|
71810121|NCT01274182|143121621|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.093|||||TWO_SIDED|90.0|0.989|1.208|||||Rituxan arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.||1.208|0.989|
71810122|NCT01274182|143121622|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.076|||||TWO_SIDED|90.0|0.979|1.184|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.184|0.979|
71810123|NCT01274182|143121622|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.131|||||TWO_SIDED|90.0|1.027|1.244|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.244|1.027|
71810124|NCT01274182|143121622|EQUIVALENCE|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.946|1.167|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.||1.167|0.946|
71810125|NCT01274182|143121623|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|0.989|||||TWO_SIDED|95.0|0.974|1.004|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.004|0.974|
71810126|NCT01274182|143121623|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.021|||||TWO_SIDED|95.0|1.003|1.04|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25||1.040|1.003|
71844000|NCT04027439|143202242|OTHER||Contrast Ratio|1.088|||<|0.0001|TWO_SIDED|95.0|1.052|1.126|||ANCOVA|||||1.126|1.052|<0.0001
71844001|NCT04027439|143202243|OTHER||Contrast Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.113|1.189|||ANCOVA|||||1.189|1.113|<0.0001
71844002|NCT04027439|143202243|OTHER||Contrast Ratio|1.146|||<|0.0001|TWO_SIDED|95.0|1.109|1.185|||ANCOVA|||||1.185|1.109|<0.0001
71844003|NCT04027439|143202243|OTHER||Contrast Ratio|1.107|||<|0.0001|TWO_SIDED|95.0|1.071|1.144|||ANCOVA|||||1.144|1.071|<0.0001
71844004|NCT04027439|143202243|OTHER||Contrast Ratio|1.094|||<|0.0001|TWO_SIDED|95.0|1.059|1.13|||ANCOVA|||||1.130|1.059|<0.0001
71844005|NCT04027439|143202244|OTHER||Contrast Ratio|1.103|||<|0.0001|TWO_SIDED|95.0|1.066|1.141|||ANCOVA|||||1.141|1.066|<0.0001
71844006|NCT04027439|143202244|OTHER||Contrast Ratio|1.078|||<|0.0001|TWO_SIDED|95.0|1.042|1.116|||ANCOVA|||||1.116|1.042|<0.0001
71813728|NCT00431184|143129734|SUPERIORITY_OR_OTHER|||||||0.83|||||||Mixed Models Analysis|||||||0.83
71813729|NCT02799472|143129755|OTHER||Ratio|14.201|||<|0.001|TWO_SIDED|95.0|6.251|32.262|||Repeated measures analysis|||GM-CSF - Complex, Week 1||32.262|6.251|<0.001
71813730|NCT02799472|143129755|OTHER||Ratio|32.36|||<|0.001|TWO_SIDED|95.0|15.828|66.156|||Repeated measures analysis|||GM-CSF - Complex, Week 2||66.156|15.828|<0.001
71813731|NCT02799472|143129755|OTHER||Ratio|55.772|||<|0.001|TWO_SIDED|95.0|25.646|121.287|||Repeated measures analysis|||GM-CSF - Complex, Week 4||121.287|25.646|<0.001
71813732|NCT02799472|143129755|OTHER||Ratio|48.336|||<|0.001|TWO_SIDED|95.0|19.341|120.798|||Repeated measures analysis|||GM-CSF - Complex, Week 6||120.798|19.341|<0.001
71813733|NCT02799472|143129755|OTHER||Ratio|34.635|||<|0.001|TWO_SIDED|95.0|13.69|87.629|||Repeated measures analysis|||GM-CSF - Complex, Week 8||87.629|13.690|<0.001
71813734|NCT02799472|143129755|OTHER||Ratio|23.249|||<|0.001|TWO_SIDED|95.0|8.579|63.005|||Repeated measures analysis|||GM-CSF - Complex, Week 12||63.005|8.579|<0.001
71813735|NCT02799472|143129755|OTHER||Ratio|1.233||||0.401|TWO_SIDED|95.0|0.742|2.048|||Repeated measures analysis|||GM-CSF - Complex, 12-Week FU||2.048|0.742|0.401
71813736|NCT02799472|143129756|OTHER||Ratio|0.943||||0.193|TWO_SIDED|95.0|0.861|1.032|||Repeated measures analysis|||14-3-3 ETA Protein, Week 1||1.032|0.861|0.193
71813737|NCT02799472|143129756|OTHER||Ratio|1.028||||0.842|TWO_SIDED|95.0|0.776|1.362|||Repeated measures analysis|||14-3-3 ETA Protein, Week 2||1.362|0.776|0.842
71813738|NCT02799472|143129756|OTHER||Ratio|0.743||||0.127|TWO_SIDED|95.0|0.505|1.093|||Repeated measures analysis|||14-3-3 ETA Protein, Week 4||1.093|0.505|0.127
71813739|NCT02799472|143129756|OTHER||Ratio|0.762||||0.137|TWO_SIDED|95.0|0.531|1.095|||Repeated measures analysis|||14-3-3 ETA Protein, Week 6||1.095|0.531|0.137
71813740|NCT02799472|143129756|OTHER||Ratio|0.886||||0.488|TWO_SIDED|95.0|0.623|1.259|||Repeated measures analysis|||14-3-3 ETA Protein, Week 8||1.259|0.623|0.488
71813741|NCT02799472|143129756|OTHER||Ratio|0.793||||0.338|TWO_SIDED|95.0|0.488|1.29|||Repeated measures analysis|||14-3-3 ETA Protein, Week 12||1.290|0.488|0.338
71813742|NCT02799472|143129756|OTHER||Ratio|0.859||||0.582|TWO_SIDED|95.0|0.491|1.502|||Repeated measures analysis|||14-3-3 ETA Protein, 12-Week FU||1.502|0.491|0.582
71813743|NCT02799472|143129756|OTHER||Ratio|0.999||||0.996|TWO_SIDED|95.0|0.699|1.427|||Repeated measures analysis|||S100 CBP A8 and A9, Week 1||1.427|0.699|0.996
71813744|NCT02799472|143129756|OTHER||Ratio|0.944||||0.745|TWO_SIDED|95.0|0.662|1.346|||Repeated measures analysis|||S100 CBP A8 and A9, Week 2||1.346|0.662|0.745
71813745|NCT02799472|143129756|OTHER||Ratio|1.017||||0.939|TWO_SIDED|95.0|0.649|1.593|||Repeated measures analysis|||S100 CBP A8 and A9, Week 4||1.593|0.649|0.939
71813746|NCT02799472|143129756|OTHER||Ratio|0.981||||0.937|TWO_SIDED|95.0|0.595|1.617|||Repeated measures analysis|||S100 CBP A8 and A9, Week 6||1.617|0.595|0.937
71813747|NCT02799472|143129756|OTHER||Ratio|1.067||||0.787|TWO_SIDED|95.0|0.659|1.727|||Repeated measures analysis|||S100 CBP A8 and A9, Week 8||1.727|0.659|0.787
71813748|NCT02799472|143129756|OTHER||Ratio|1.267||||0.342|TWO_SIDED|95.0|0.769|2.086|||Repeated measures analysis|||S100 CBP A8 and A9, Week 12||2.086|0.769|0.342
71813749|NCT02799472|143129756|OTHER||Ratio|1.748||||0.026|TWO_SIDED|95.0|1.076|2.838|||Repeated measures analysis|||S100 CBP A8 and A9, 12-Week FU||2.838|1.076|0.026
71813750|NCT02799472|143129757|OTHER||Ratio|0.774||||0.632|TWO_SIDED|95.0|0.261|2.29|||Repeated measures analysis|||Amyloid A, Week 12||2.290|0.261|0.632
71813751|NCT02799472|143129757|OTHER||Ratio|1.176||||0.685|TWO_SIDED|95.0|0.519|2.663|||Repeated measures analysis|||Amyloid A, 12-Week FU||2.663|0.519|0.685
71813752|NCT02799472|143129758|OTHER||Ratio|0.692||||0.097|TWO_SIDED|95.0|0.445|1.074|||Repeated measures analysis|||CL17, Week 1||1.074|0.445|0.097
71813753|NCT02799472|143129758|OTHER||Ratio|0.713||||0.229|TWO_SIDED|95.0|0.407|1.249|||Repeated measures analysis|||CL17, Week 2||1.249|0.407|0.229
71813754|NCT02799472|143129758|OTHER||Ratio|0.608||||0.055|TWO_SIDED|95.0|0.365|1.012|||Repeated measures analysis|||CL17, Week 4||1.012|0.365|0.055
71813755|NCT02799472|143129758|OTHER||Ratio|0.755||||0.307|TWO_SIDED|95.0|0.435|1.309|||Repeated measures analysis|||CL17, Week 6||1.309|0.435|0.307
71813756|NCT02799472|143129758|OTHER||Ratio|0.557||||0.017|TWO_SIDED|95.0|0.348|0.894|||Repeated measures analysis|||CL17, Week 8||0.894|0.348|0.017
71813757|NCT02799472|143129758|OTHER||Ratio|0.52||||0.026|TWO_SIDED|95.0|0.294|0.922|||Repeated measures analysis|||||0.922|0.294|0.026
71813758|NCT02799472|143129758|OTHER||Ratio|0.947||||0.839|TWO_SIDED|95.0|0.548|1.636|||Repeated measures analysis|||CL17, 12-Week FU||1.636|0.548|0.839
71813759|NCT02799472|143129758|OTHER||Ratio|0.764||||0.142|TWO_SIDED|95.0|0.53|1.1|||Repeated measures analysis|||CL13, Week 1||1.100|0.530|0.142
71813760|NCT02799472|143129758|OTHER||Ratio|1.005||||0.976|TWO_SIDED|95.0|0.726|1.39|||Repeated measures analysis|||CL13, Week 2||1.390|0.726|0.976
71813761|NCT02799472|143129758|OTHER||Ratio|1.236||||0.244|TWO_SIDED|95.0|0.859|1.778|||Repeated measures analysis|||CL13, Week 4||1.778|0.859|0.244
71813762|NCT02799472|143129758|OTHER||Ratio|1.237||||0.278|TWO_SIDED|95.0|0.836|1.83|||Repeated measures analysis|||CL13, Week 6||1.830|0.836|0.278
71813763|NCT02799472|143129758|OTHER||Ratio|1.118||||0.677|TWO_SIDED|95.0|0.651|1.92|||Repeated measures analysis|||CL13, Week 8||1.920|0.651|0.677
71813764|NCT02799472|143129758|OTHER||Ratio|1.165||||0.661|TWO_SIDED|95.0|0.573|2.369|||Repeated measures analysis|||CL13, Week 12||2.369|0.573|0.661
71813765|NCT02799472|143129758|OTHER||Ratio|1.581||||0.154|TWO_SIDED|95.0|0.832|3.007|||Repeated measures analysis|||CL13, 12-Week FU||3.007|0.832|0.154
71813766|NCT02799472|143129758|OTHER||Ratio|0.903||||0.751|TWO_SIDED|95.0|0.471|1.729|||Repeated measures analysis|||Interleukin 6, Week 1||1.729|0.471|0.751
71810127|NCT01274182|143121623|EQUIVALENCE|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.033|||||TWO_SIDED|95.0|1.016|1.05|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalence limits of 0.8-1.25||1.050|1.016|
71810128|NCT01274182|143121624|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6.~LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.397|0.24|||||The direction of comparison is LS mean of GP2013 - LS mean of Rituxan|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.240|-0.397|
71810129|NCT01274182|143121624|NON_INFERIORITY|"The non-inferiority margin is further justified by the EULAR criteria which define no response as change from baseline being \< 0.6. LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment\*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.201|||TWO_SIDED|95.0|-0.328|0.462|||||The direction of comparison is LS mean of GP2013 Part I - LS mean of MabThera|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.||0.462|-0.328|
71810130|NCT01274182|143121625|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|9.77|STANDARD_ERROR_OF_MEAN|6.79|||TWO_SIDED|95.0|-3.54|23.08|||||The direction of comparison is response rate of GP2013 - response rate of Rituxan|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||23.08|-3.54|
71810131|NCT01274182|143121625|NON_INFERIORITY|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|-0.57|STANDARD_ERROR_OF_MEAN|7.23|||TWO_SIDED|95.0|-14.74|13.6|||||The direction of comparison is response rate of GP2013 Part I - response rate of MabThera|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.||13.60|-14.74|
71810132|NCT01984684|143121633|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in responder rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|3.1|||||TWO_SIDED|95.0|-2.0|8.3||||||||8.3|-2.0|
71810133|NCT01984684|143121634|NON_INFERIORITY|Analysis of the investigator's assessment of response of signs and symptoms of infection (cure only) was performed using the Miettinen-Nurminen method without stratification for the ITT analysis set.|Difference in Cure Rates|-2.0|||||TWO_SIDED|95.0|-8.6|4.6||||||||4.6|-8.6|
71810134|NCT01984684|143121635|NON_INFERIORITY|Analysis of the investigator's assessment of response (cure only) at the Late Follow-up Visit was assessed using the Miettinen-Nurminen method without stratification.|Difference in Cure Rates|-3.1|||||TWO_SIDED|95.0|-9.3|3.1||||||||3.1|-9.3|
71810135|NCT01375114|143121636|OTHER|||||||0.67|||||||Chi-squared|||||||0.67
71810136|NCT01375114|143121637|OTHER|||||||0.71|||||||Chi-squared|||||||0.71
71810137|NCT01375114|143121638|OTHER|||||||0.34|||||||Chi-squared|||||||0.34
71810138|NCT01375114|143121639|OTHER|||||||0.36|||||||Chi-squared|||||||0.36
71810139|NCT01375114|143121640|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
71810140|NCT01215292|143121651|NON_INFERIORITY_OR_EQUIVALENCE|80% power to detect 20% difference in ITT|||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
71810141|NCT01215292|143121652|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
71810142|NCT01215292|143121653|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||<0.05
71810143|NCT00689221|143121654|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.021||||0.8623|TWO_SIDED|95.0|0.808|1.291||P-value is not adjusted for multiple testing.|Log Rank|||||1.291|0.808|0.8623
71810144|NCT01596582|143121674|SUPERIORITY|||||||0.4|||||||Chi-squared|||||||0.40
71810145|NCT01596582|143121675|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71810146|NCT01596582|143121676|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71810147|NCT01596582|143121677|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71810148|NCT01596582|143121678|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71810149|NCT01596582|143121679|SUPERIORITY||||||>|0.05||||||The p-value for each comparison was non-significanct.|Wilcoxon (Mann-Whitney)|||||||>0.05
71810150|NCT01596582|143121680|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71810151|NCT01596582|143121681|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71810152|NCT01596582|143121682|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71810153|NCT01596582|143121683|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
71813767|NCT02799472|143129758|OTHER||Ratio|0.72||||0.33|TWO_SIDED|95.0|0.367|1.413|||Repeated measures analysis|||Interleukin 6, Week 2||1.413|0.367|0.330
71813768|NCT02799472|143129758|OTHER||Ratio|0.822||||0.519|TWO_SIDED|95.0|0.447|1.512|||Repeated measures analysis|||Interleukin 6, Week 4||1.512|0.447|0.519
71813769|NCT02799472|143129758|OTHER||Ratio|0.659||||0.147|TWO_SIDED|95.0|0.372|1.167|||Repeated measures analysis|||Interleukin 6, Week 6||1.167|0.372|0.147
71676468|NCT02729051|142870757|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.68|1.12|||||Analysis was performed using a Cox proportional hazards model.|||1.12|0.68|
71676469|NCT02702388|142870758|NON_INFERIORITY|Odds ratio of ORR as of Week 24 response (18 mg vs 24 mg) along with its 95% confidence interval (CI) using the Cochran-Mantel-Haenszel (CMH) method, stratified by the randomization stratification factors. The test was performed per the 95% CI using the noninferiority margin of 0.4. Noninferiority will be declared if the lower limit of the 95% CI for the odds ratio is greater than 0.4.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.26|0.96||||||||0.96|0.26|
71676470|NCT04740827|142870802|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.426|<|0.0001|TWO_SIDED|95.0|-3.27|-1.59|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.59|-3.27|<0.0001
71676471|NCT04740827|142870803|SUPERIORITY||Least Squares Mean Difference|-2.35|STANDARD_ERROR_OF_MEAN|0.425|<|0.0001|TWO_SIDED|95.0|-3.19|-1.52|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-1.52|-3.19|<0.0001
71676472|NCT04740827|142870804|SUPERIORITY||Odds Ratio (OR)|5.15|||<|0.0001|TWO_SIDED|95.0|3.02|8.79|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.79|3.02|<0.0001
71676473|NCT04740827|142870805|SUPERIORITY||Odds Ratio (OR)|4.82|||<|0.0001|TWO_SIDED|95.0|2.85|8.14|||Regression, Logistic||Odds ratio and p-value are based on logistic regression with treatment group, region, baseline monthly migraine days, and number of classes of failed prior prophylactic treatments (2 and \>2) as explanatory variables.|||8.14|2.85|<0.0001
71676474|NCT04740827|142870806|SUPERIORITY||Least Squares Mean Difference|-2.28|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.42|-3.15|<0.0001
71676475|NCT04740827|142870807|SUPERIORITY||Least Squares Mean Difference|-2.19|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|-3.05|-1.32|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.32|-3.05|<0.0001
71676476|NCT04740827|142870808|SUPERIORITY||Least Squares Mean Difference|-2.68|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|-3.43|-1.93|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.93|-3.43|<0.0001
71676477|NCT04740827|142870809|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-3.36|-1.86|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-1.86|-3.36|<0.0001
71810154|NCT04672941|143121691|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the CAT score at each visit. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-5.28|||||TWO_SIDED|95.0|-5.67|-4.89|||||Least Square Mean for Visit, change from baseline (3 months - baseline) total CAT Score estimates.|||-4.89|-5.67|
71810155|NCT04672941|143121692|OTHER|The logistic generalized estimating equations (GEE) model with CAT response \>= 10 as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|7.186|||<|0.001|TWO_SIDED|95.0|5.745|8.987|||Regression, Logistic||Odds ratio for Visit.|||8.987|5.745|< 0.001
71676478|NCT04740827|142870810|SUPERIORITY||Least Squares Mean Difference|17.67|STANDARD_ERROR_OF_MEAN|2.348|<|0.0001|TWO_SIDED|95.0|13.05|22.3|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.30|13.05|<0.0001
71810156|NCT04672941|143121693|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was EQ-VAS score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|11.8|||||TWO_SIDED|95.0|11.0|12.6|||||Least Square Mean for Visit, mean change from Baseline (3 months - baseline) of EQ-VAS based on non-responder imputation.|||12.60|11.00|
71813770|NCT02799472|143129758|OTHER||Ratio|0.684||||0.166|TWO_SIDED|95.0|0.396|1.18|||Repeated measures analysis|||Interleukin 6, Week 8||1.180|0.396|0.166
71676479|NCT04740827|142870811|SUPERIORITY||Least Squares Mean Difference|17.88|STANDARD_ERROR_OF_MEAN|2.308|<|0.0001|TWO_SIDED|95.0|13.34|22.42|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||22.42|13.34|<0.0001
71676480|NCT04740827|142870812|SUPERIORITY||Least Squares Mean Difference|-4.71|STANDARD_ERROR_OF_MEAN|0.844|<|0.0001|TWO_SIDED|95.0|-6.37|-3.05|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-3.05|-6.37|<0.0001
71676481|NCT04740827|142870813|SUPERIORITY||Least Squares Mean Difference|-4.39|STANDARD_ERROR_OF_MEAN|0.786|<|0.0001|TWO_SIDED|95.0|-5.94|-2.85|||MMRM||MMRM=baseline as covariate, treatment group, visit, region, number of classes of failed prior treatments, number of migraine days during baseline period as fixed factors; treatment group and baseline-by-visit with an unstructured covariance matrix.|||-2.85|-5.94|<0.0001
71813771|NCT02799472|143129758|OTHER||Ratio|1.221||||0.432|TWO_SIDED|95.0|0.734|2.031|||Repeated measures analysis|||Interleukin 6, Week 12||2.031|0.734|0.432
71810157|NCT04672941|143121694|OTHER|The logistic generalized estimating equations (GEE) model with mobility as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|3.9|5.14|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.14|3.90|< 0.001
71810158|NCT04672941|143121695|OTHER|The logistic generalized estimating equations (GEE) model with self-care as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|2.64|||<|0.001|TWO_SIDED|95.0|2.35|2.96|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||2.96|2.35|< 0.001
71810159|NCT04672941|143121696|OTHER|The logistic generalized estimating equations (GEE) model with usual activities as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|4.46|||<|0.001|TWO_SIDED|95.0|3.89|5.12|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||5.12|3.89|< 0.001
71810160|NCT04672941|143121697|OTHER|The logistic generalized estimating equations (GEE) model with pain/discomfort as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|3.0|3.85|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.85|3.00|< 0.001
71810161|NCT04672941|143121698|OTHER|The logistic generalized estimating equations (GEE) model with anxiety/depression as dependent variable. Visit, Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates and unstructured covariance matrix was used.|Odds Ratio (OR)|3.32|||<|0.001|TWO_SIDED|95.0|2.95|3.73|||Regression, Logistic||Odds ratio for Visit (3 months / baseline (reference)).|||3.73|2.95|< 0.001
71810162|NCT04672941|143121704|OTHER|Mixed model for repeated measurements (MMRM) assuming random missingness was fitted. The dependent variable was the mMRC score. Visit, Global Initiative for Chronic Obstructive Lung Disease (GOLD) group, smoking habits, pack years, sex, age, and comorbidities appearing at a rate greater than 5% were entered as covariates.|Score on a scale|-0.55|||||TWO_SIDED|95.0|-0.6|-0.51|||||Least Square Mean for Visit, change from baseline (3 months - baseline) of mMRC based on non-responder imputation.|||-0.51|-0.60|
71810163|NCT00765388|143121710|SUPERIORITY_OR_OTHER|||||||0.96|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.96
71810164|NCT00765388|143121712|SUPERIORITY_OR_OTHER|||||||0.92|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products||||||0.92
71810165|NCT00765388|143121714|SUPERIORITY_OR_OTHER|||||||0.4||0.0|||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.40
71810166|NCT00765388|143121715|SUPERIORITY_OR_OTHER|||||||0.64|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.64
71810167|NCT00765388|143121716|SUPERIORITY_OR_OTHER|||||||0.55|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.55
71810168|NCT00765388|143121717|SUPERIORITY_OR_OTHER|||||||0.48|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products||||||0.48
71810169|NCT03923933|143121724|SUPERIORITY||||||<|0.001|||||||ANOVA|anova repeated measures||||||<0.001
71810170|NCT03923933|143121725|SUPERIORITY|||||||0.006|||||||ANOVA|Repeated Measures||||||0.006
71810171|NCT03923933|143121726|SUPERIORITY|||||||0.371|||||||ANOVA|||||||0.371
71810172|NCT03923933|143121727|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71810173|NCT03923933|143121729|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
71844007|NCT04027439|143202244|OTHER||Contrast Ratio|1.067||||0.0002|TWO_SIDED|95.0|1.032|1.104|||ANCOVA|||||1.104|1.032|0.0002
71810174|NCT03923933|143121730|SUPERIORITY|||||||0.018|||||||ANOVA|||||||0.018
71810175|NCT00419263|143121731|SUPERIORITY_OR_OTHER|||||||0.377|TWO_SIDED||||||Regression, Cox|P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.||||||0.377
71810176|NCT00419263|143121732|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.007
71810177|NCT00419263|143121733|SUPERIORITY_OR_OTHER|||||||0.537|TWO_SIDED|||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank|||||||0.537
71810178|NCT00419263|143121734|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.002
71810179|NCT00419263|143121735|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||< 0.001
71810180|NCT00419263|143121736|SUPERIORITY_OR_OTHER|||||||0.409|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.409
71810181|NCT00419263|143121737|SUPERIORITY_OR_OTHER|||||||0.327|TWO_SIDED|||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)|||||||0.327
71813772|NCT02799472|143129758|OTHER||Ratio|1.602||||0.216|TWO_SIDED|95.0|0.75|3.423|||Repeated measures analysis|||Interleukin 6, 12-Week FU||3.423|0.750|0.216
71813773|NCT02799472|143129758|OTHER||Ratio|0.926||||0.195|TWO_SIDED|95.0|0.823|1.042|||Repeated measures analysis|||MDC, Week 1||1.042|0.823|0.195
71813774|NCT02799472|143129758|OTHER||Ratio|0.984||||0.851|TWO_SIDED|95.0|0.829|1.168|||Repeated measures analysis|||MDC, Week 2||1.168|0.829|0.851
71810182|NCT01563536|143121764|SUPERIORITY_OR_OTHER||Mean Difference (Maximal Decrease)|-1.5||||0.035|TWO_SIDED|95.0|-2.81|-0.13||Pre-specified 2-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.||||-0.13|-2.81|0.035
71810183|NCT00538590|143121768|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.95
71810184|NCT00538590|143121770|SUPERIORITY_OR_OTHER|||||||1||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||1.00
71810185|NCT00538590|143121771|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.40
71810186|NCT00538590|143121772|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.||||0.91
71810187|NCT00541450|143121843|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.002
71810188|NCT00541450|143121844|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.001
71810189|NCT00541450|143121845|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.16||||||95.0|-0.37|0.05|||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||0.05|-0.37|
71810190|NCT00541450|143121847|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.||||||0.030
71810191|NCT00803452|143121862|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||.001
71810192|NCT02816138|143121881|OTHER||||||<|0.001|||||||Regression, Linear|For change in depression severity (MADRS) over time, we used a linear mixed effects model with autoregressive of order 1 (AR(1)) temporal process.||||||<0.001
71810193|NCT02816138|143121882|OTHER|||||||0.761|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.761
71810194|NCT02816138|143121883|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.084
71810195|NCT02816138|143121884|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks||||0.073
71810196|NCT02816138|143121885|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.002
71810197|NCT02816138|143121886|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
71810198|NCT02816138|143121887|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test||||||0.049
71810199|NCT02816138|143121888|OTHER|||||||0.502|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.502
71810200|NCT02816138|143121889|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.049
71810201|NCT02816138|143121890|OTHER|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.068
71810202|NCT00981084|143121901|SUPERIORITY_OR_OTHER||||||=|0.19||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .19
71813775|NCT02799472|143129758|OTHER||Ratio|0.956||||0.637|TWO_SIDED|95.0|0.79|1.158|||Repeated measures analysis|||MDC, Week 4||1.158|0.790|0.637
71813776|NCT02799472|143129758|OTHER||Ratio|1.01||||0.915|TWO_SIDED|95.0|0.833|1.225|||Repeated measures analysis|||MDC, Week 6||1.225|0.833|0.915
71813777|NCT02799472|143129758|OTHER||Ratio|0.857||||0.157|TWO_SIDED|95.0|0.69|1.064|||Repeated measures analysis|||MDC, Week 8||1.064|0.690|0.157
71813778|NCT02799472|143129758|OTHER||Ratio|0.849||||0.142|TWO_SIDED|95.0|0.681|1.059|||Repeated measures analysis|||MDC, Week 12||1.059|0.681|0.142
71813779|NCT02799472|143129758|OTHER||Ratio|1.013||||0.929|TWO_SIDED|95.0|0.745|1.378|||Repeated measures analysis|||MDC, 12-Week FU||1.378|0.745|0.929
71813780|NCT02799472|143129759|OTHER||Ratio|0.887||||0.463|TWO_SIDED|95.0|0.64|1.231|||Repeated measures analysis|||Chitinase 3 Like 1, Week 1||1.231|0.640|0.463
71813781|NCT02799472|143129759|OTHER||Ratio|0.953||||0.782|TWO_SIDED|95.0|0.672|1.352|||Repeated measures analysis|||Chitinase 3 Like 1, Week 2||1.352|0.672|0.782
71813782|NCT02799472|143129759|OTHER||Ratio|1.132||||0.533|TWO_SIDED|95.0|0.759|1.69|||Repeated measures analysis|||Chitinase 3 Like 1, Week 4||1.690|0.759|0.533
71813783|NCT02799472|143129759|OTHER||Ratio|1.149||||0.473|TWO_SIDED|95.0|0.779|1.694|||Repeated measures analysis|||Chitinase 3 Like 1, Week 6||1.694|0.779|0.473
71813784|NCT02799472|143129759|OTHER||Ratio|1.112||||0.608|TWO_SIDED|95.0|0.733|1.687|||Repeated measures analysis|||Chitinase 3 Like 1, Week 8||1.687|0.733|0.608
71813785|NCT02799472|143129759|OTHER||Ratio|1.005||||0.985|TWO_SIDED|95.0|0.613|1.645|||Repeated measures analysis|||Chitinase 3 Like 1, Week 12||1.645|0.613|0.985
71813786|NCT02799472|143129759|OTHER||Ratio|1.386||||0.102|TWO_SIDED|95.0|0.934|2.057|||Repeated measures analysis|||Chitinase 3 Like 1, 12-Week FU||2.057|0.934|0.102
71813787|NCT02799472|143129759|OTHER||Ratio|0.915||||0.259|TWO_SIDED|95.0|0.781|1.071|||Repeated measures analysis|||MMP-3, Week 1||1.071|0.781|0.259
71813788|NCT02799472|143129759|OTHER||Ratio|0.959||||0.621|TWO_SIDED|95.0|0.809|1.137|||Repeated measures analysis|||MMP-3, Week 2||1.137|0.809|0.621
71813789|NCT02799472|143129759|OTHER||Ratio|0.914||||0.354|TWO_SIDED|95.0|0.752|1.11|||Repeated measures analysis|||MMP-3, Week 4||1.110|0.752|0.354
71813790|NCT02799472|143129759|OTHER||Ratio|0.8||||0.448|TWO_SIDED|95.0|0.443|1.444|||Repeated measures analysis|||MMP-3, Week 6||1.444|0.443|0.448
71813791|NCT02799472|143129759|OTHER||Ratio|1.16||||0.402|TWO_SIDED|95.0|0.813|1.653|||Repeated measures analysis|||MMP-3, Week 8||1.653|0.813|0.402
71813792|NCT02799472|143129759|OTHER||Ratio|0.951||||0.745|TWO_SIDED|95.0|0.695|1.301|||Repeated measures analysis|||MMP-3, Week 12||1.301|0.695|0.745
71813793|NCT02799472|143129759|OTHER||Ratio|1.226||||0.279|TWO_SIDED|95.0|0.837|1.796|||Repeated measures analysis|||MMP-3, 12-Week FU||1.796|0.837|0.279
71813794|NCT02799472|143129760|OTHER||Ratio|1.098||||0.621|TWO_SIDED|95.0|0.75|1.606|||Repeated measures analysis|||ARGS Neo-Epitope, Week 1||1.606|0.750|0.621
71676482|NCT04740827|142870814|SUPERIORITY||Least Squares Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.912|<|0.0001|TWO_SIDED|95.0|-8.22|-4.63|||MMRM||MMRM=baseline monthly migraine days as covariate, treatment group, visit, region and number of classes of failed prior treatments as fixed factors; treatment group and baseline-by-visit as interaction terms, with an unstructured covariance matrix.|||-4.63|-8.22|<0.0001
71810203|NCT00981084|143121901|SUPERIORITY_OR_OTHER||||||=|0.0005||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .0005
71810204|NCT00981084|143121901|SUPERIORITY_OR_OTHER||||||=|0.21||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .21
71810205|NCT00981084|143121901|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||= .10
71810206|NCT00981084|143121902|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the CPT, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.33
71810207|NCT00981084|143121903|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Stroop, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.37
71810208|NCT00981084|143121904|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Word Generation, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.||||.53
71810209|NCT02291679|143121905|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.0001|TWO_SIDED|95.0|1.76|5.2||P-value is obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% confidence interval (CI) for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||5.20|1.76|< 0.0001
71810210|NCT02291679|143121906|SUPERIORITY||LS Mean Difference|0.841|||<|0.0001|TWO_SIDED|95.0|0.505|1.176||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.176|0.505|< 0.0001
71810211|NCT02291679|143121907|SUPERIORITY||LS Mean Difference|1.037|||<|0.0001|TWO_SIDED|95.0|0.636|1.438||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||1.438|0.636|< 0.0001
71810212|NCT02291679|143121908|SUPERIORITY||LS Mean Difference|0.628|||<|0.0001|TWO_SIDED|95.0|0.45|0.806||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.806|0.450|< 0.0001
71810213|NCT02291679|143121909|SUPERIORITY||LS Mean Difference|-0.329|||<|0.0001|TWO_SIDED|95.0|-0.449|-0.21||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.210|-0.449|< 0.0001
71810214|NCT02291679|143121910|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0008|TWO_SIDED|95.0|1.47|4.87||P-value is obtained from the CMH tests controlling for geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region.|||4.87|1.47|0.0008
71844008|NCT04027439|143202244|OTHER||Contrast Ratio|1.048||||0.0066|TWO_SIDED|95.0|1.013|1.084|||ANCOVA|||||1.084|1.013|0.0066
71676483|NCT04445714|142870832|SUPERIORITY||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.34|-1.03|||Paired t-test test|||Change from baseline||-1.03|-1.34|<.0001
71676484|NCT04445714|142870833|SUPERIORITY||Mean Difference (Final Values)|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.51|||Paired t-test test|||Change from baseline||-1.51|-2.66|<.0001
71676485|NCT04445714|142870834|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.8416|TWO_SIDED|95.0|-2.34|1.91|||Paired t-test test|||Change from baseline||1.91|-2.34|0.8416
71810215|NCT02291679|143121911|SUPERIORITY||Odds Ratio (OR)|2.58|||<|0.0001|TWO_SIDED|95.0|1.58|4.2||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||4.20|1.58|< 0.0001
71810216|NCT02291679|143121912|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0002|TWO_SIDED|95.0|1.42|3.26||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||3.26|1.42|0.0002
71844009|NCT00979121|143202267|SUPERIORITY_OR_OTHER||difference in % of pts alive at 60 days|4.0||||0.21|TWO_SIDED|95.0|-2.3|10.2||The monitoring boundaries were designed to have a low probability of stopping for futility before 750 patients. The maximum sample size was 1000 patients. Efficacy stopping was based on mortality; futility stopping was based on mortality and VFDs.|Proc lifetest|Proc lifetest was used to calculate mortality mean and variance due to one subject lost to follow up who was censored.||Hospital mortality to day 60 was estimated using the Kaplan Meier estimate, with patients discharged home before day 60 considered alive at day 60. The analysis was stratified by co-enrolled treatment assignments for 81 patients also enrolled in a randomized clinical trial of two different nutritional strategies. A maximum of 1000 patients were to be enrolled, providing a 92% probability of rejecting the null hypothesis for the effect on mortality if a true difference in mortality was 9%.||10.2|-2.3|0.21
71844010|NCT00979121|143202268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.96||95.0|-1.6|1.5|||ANCOVA|||Ventilator, ICU free, and organ failure free days were analyzed by analysis of variance, utilizing treatment assignment where applicable.||1.5|-1.6|0.96
71844011|NCT00859781|143202284|SUPERIORITY||proportion difference|0.26||||0.08|TWO_SIDED|95.0|0.008|0.52|||Fisher Exact||Direction = 177Lu-J591 + Ketoconazole proportion free of radiographically evident metastases minus 111ln-J591 + Ketoconazole proportion free of radiographically evident metastases.|||0.52|0.008|0.08
71844012|NCT04057820|143202292|SUPERIORITY||Incidence rate ratio (IRR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.46|0.65|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.65|0.46|<0.0001
71844013|NCT04057820|143202293|SUPERIORITY||Risk Ratio (RR)|0.38|||<|0.0001|TWO_SIDED|95.0|0.3|0.47|||Mixed-effect Poisson w/ robust err var|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.47|0.30|<0.0001
71844014|NCT04057820|143202294|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-0.4|4.9||||||||4.9|-0.4|
71844015|NCT04057820|143202295|SUPERIORITY||Mean Difference (Final Values)|23.0|||||TWO_SIDED|95.0|8.1|37.9||||||||37.9|8.1|
71844016|NCT04057820|143202296|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.37|1.76||||||||1.76|0.37|
71844017|NCT04057820|143202297|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||||1.0|-0.3|
71844018|NCT04057820|143202298|SUPERIORITY||Risk Ratio (RR)|1.94|||||TWO_SIDED|95.0|0.94|3.99||||||||3.99|0.94|
71810217|NCT02291679|143121913|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0342|TWO_SIDED|95.0|1.03|2.17||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.|||2.17|1.03|0.0342
71810218|NCT02291679|143121914|SUPERIORITY||LS Mean Difference|-0.319||||0.0063|TWO_SIDED|95.0|-0.548|-0.09||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||-0.090|-0.548|0.0063
71844019|NCT04057820|143202299|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|1.13|2.48||||||||2.48|1.13|
71844020|NCT04057820|143202300|SUPERIORITY||Incidence ratio ratio (IRR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Mixed Models Analysis|The model adjusted for study design (i.e., fixed time effect and random site effect) and randomization scheme stratification indicator.||||0.64|0.49|
71844021|NCT04057820|143202302|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.71|1.47||||||||1.47|0.71|
71844022|NCT00227266|143202356|SUPERIORITY_OR_OTHER_LEGACY||Spearman's correlation|0.93|||<|0.001|||||||Spearman's correlation|||MHFMS-Extend was not normally distributed at p=0.048. Test-retest reliability of MHFMS-Extend measurements from the first (S1) to the second (S2) screening visit was analyzed using Spearman's correlation.||||<0.001
71844023|NCT02678689|143202361|SUPERIORITY|The two-sample T-test with unequal variance was conducted at a significance level of 0.05|||||<|0.0001|||||||t-test, unequal variance|||||||< 0.0001
71844024|NCT02678689|143202362|SUPERIORITY||Hazard Ratio (HR)|0.091|||<|0.0001|TWO_SIDED|95.0|0.021|0.393|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.393|0.021|<.0001
71844025|NCT02678689|143202363|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0032|TWO_SIDED|95.0|0.0|0.0|||Cox Model Wald Test||Hazard ratio is based on Cox proportional hazards model with a factor of study group|||0.000|0.000|0.0032
71844026|NCT02678689|143202364|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
71844027|NCT02678689|143202365|SUPERIORITY||||||<|0.0001|||||||t-test, unequal variance|||||||<.0001
71844028|NCT02678689|143202366|SUPERIORITY||Hazard Ratio (HR)|0.209||||0.0081|TWO_SIDED|95.0|0.059|0.735|||Cox Model Wald Test|The p value is a test that the hazard ratio equal to 1.|"Hazard ratio is based on Cox proportional hazards model with a factor of study group.~Hazard Ratio (HR) 190-203 vs DEM-CHILD."|||0.735|0.059|0.0081
71844029|NCT02307682|143202429|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98||0.0003|TWO_SIDED|95.0|-2.5|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.5|0.0003
71895373|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|||||TWO_SIDED|80.0|-0.5|3.88||||||Compared with Baseline (Pre-lunch)||3.88|-0.50|
71895374|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.07|||||TWO_SIDED|80.0|1.56|6.58||||||Compared with Baseline (Pre-lunch)||6.58|1.56|
71810219|NCT02291679|143121915|SUPERIORITY||LS Mean Difference|-0.178||||0.1028|TWO_SIDED|95.0|-0.391|0.036||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|||0.036|-0.391|0.1028
71810220|NCT02291679|143121916|SUPERIORITY||Odds Ratio (OR)|2.78||||0.0001|TWO_SIDED|95.0|1.61|4.8||P-value is obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|||4.80|1.61|0.0001
71810221|NCT02048072|143121917|SUPERIORITY_OR_OTHER|||||||0.02|||||||t-test, 1 sided|||||||0.02
71810222|NCT01031810|143121924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_DEVIATION|10.81||0.012|TWO_SIDED|95.0|3.25|19.86|||paired t-test 2 sided|||Compare the mean differences between baseline (week00) and week12 hamd17 summary scores||19.86|3.25|0.012
71810223|NCT03073148|143122000|EQUIVALENCE|alpha = 0.05||||||0.3577|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3577
71810224|NCT03073148|143122000|EQUIVALENCE|alpha = 0.05||||||0.9917|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.9917
71844030|NCT02307682|143202429|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-2.1|1.8||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.8|-2.1|<0.0001
71810225|NCT03073148|143122001|EQUIVALENCE|alpha = 0.05||||||0.3239|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.3239
71810226|NCT03073148|143122001|EQUIVALENCE|alpha = 0.05||||||0.8343|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.8343
71810227|NCT03073148|143122002|EQUIVALENCE|alpha = 0.05||||||0.4134|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.4134
71810228|NCT03073148|143122002|EQUIVALENCE|alpha = 0.05||||||0.1192|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1192
71810229|NCT03073148|143122004|EQUIVALENCE|alpha = 0.05||||||0.1753||||||Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.|ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1753
71810230|NCT03073148|143122004|EQUIVALENCE|alpha = 0.05||||||0.1843|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1843
71810231|NCT03073148|143122005|EQUIVALENCE|alpha = 0.05||||||0.0765|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.0765
71810232|NCT03073148|143122005|EQUIVALENCE|alpha = 0.05||||||0.152|||||||ANOVA|Repeated measures ANOVA comparing baseline, 1 day after treatment, and final assessment.||||||0.1520
71810233|NCT00993655|143122022|SUPERIORITY|||||||0.065|||||||Cochran-Mantel-Haenszel|adjusting for stratification factors at randomization||Assume that the 9-month PD rate in IV arm (Arm 1) will be 40% (based on experience with data from NCIC CTG OV.16 and that of NCRI UK). The target sample size of 200 will enable the detection of a 19% difference between Arms 1 and 3 in 9 month progression disease rate post randomization with 80% power at two-sided 0.05 level.||||0.065
71810234|NCT00993655|143122023|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.27|TWO_SIDED|95.0|0.85|1.75|||Log Rank|Adjusting for stratification factors at randomization||||1.75|0.85|0.27
71810235|NCT00993655|143122024|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.4|TWO_SIDED|95.0|0.74|2.13|||Log Rank|Adjusting for stratification factors at randomization||||2.13|0.74|0.40
71895375|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|80.0|-2.42|2.4||||||Compared with Baseline (Pre-lunch)||2.40|-2.42|
71895376|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|80.0|-1.62|5.01||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.01|-1.62|
71895377|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|80.0|0.54|7.62||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||7.62|0.54|
71895378|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|80.0|-3.66|2.27||||||Compared with Baseline (Pre-dinner)||2.27|-3.66|
71895379|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|80.0|1.7|8.43||||||Compared with Baseline (Pre-dinner)||8.43|1.70|
71810236|NCT00772590|143122044|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||||||<0.01
71810237|NCT00152464|143122063|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.002|||=|0.991|TWO_SIDED|95.0|0.75|1.338|||Regression, Cox|||||1.338|0.750|=0.991
71810238|NCT01644734|143122074|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no change in the total CAT score between baseline and after 3 months.||||<0.001
71810239|NCT04322604|143122076|SUPERIORITY||Percent Difference from Placebo|80.1|||<|0.0001|TWO_SIDED|95.0|70.1|87.9|||Fisher Exact|||||87.9|70.1|<0.0001
71810240|NCT04322604|143122077|SUPERIORITY||LSM Difference from Placebo|1.5||||0.3427|TWO_SIDED|95.0|-1.6|4.7|||ANCOVA|||||4.7|-1.6|0.3427
71810241|NCT04322604|143122078|SUPERIORITY||LSM Difference from Placebo|-41.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-34.2|||ANCOVA|||||-34.2|-48.1|<0.0001
71810242|NCT04322604|143122079|SUPERIORITY||Percent Difference from Placebo|81.3|||<|0.0001|TWO_SIDED|95.0|71.7|88.8|||Fisher Exact|||||88.8|71.7|<0.0001
71810243|NCT04322604|143122080|SUPERIORITY||Percent Difference from Placebo|39.5|||<|0.0001|TWO_SIDED|95.0|25.4|52.2|||Fisher Exact|||||52.2|25.4|<0.0001
71810244|NCT04322604|143122081|SUPERIORITY||Percent Difference from Placebo|7.0||||0.3549|TWO_SIDED|95.0|-7.4|21.6|||Fisher Exact|||||21.6|-7.4|0.3549
71676486|NCT04445714|142870835|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.0001|TWO_SIDED|95.0|-33.4|-15.4|||Paired t-test test|||Change from baseline||-15.4|-33.4|<.0001
71676487|NCT02805660|142870837|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.537|||||||Exact Test|||||||0.537
71676488|NCT02805660|142870837|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.|||||>|0.999|||||||Exact Test|||||||>0.999
71810245|NCT04322604|143122082|SUPERIORITY||Percent Difference from Placebo|8.3||||0.2262|TWO_SIDED|95.0|-6.3|22.7|||Fisher Exact|||||22.7|-6.3|0.2262
71810246|NCT04322604|143122083|SUPERIORITY||LSM Difference from Placebo|5.0||||0.3812|TWO_SIDED|95.0|-6.1|16.0|||Mixed Models Analysis|||Week 24 Percent Change from Baseline||16.0|-6.1|0.3812
71844031|NCT02307682|143202430|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-2.4|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||1.3|-2.4|0.0001
71844032|NCT02307682|143202430|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-1.9|1.9||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.9|-1.9|<0.0001
71844033|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-1.4|0.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||0.9|-1.4|
71844034|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.4|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.1|-1.4|
71676489|NCT02805660|142870837|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.283|||||||Exact Test|||||||0.283
71676490|NCT02805660|142870837|SUPERIORITY|An exact test for single proportion was performed to test null hypothesis (H0): ORR \<= 5% against alternative hypothesis (H1): ORR \> 5% for Cohorts 1, 3, and 4 and to test H0: ORR \<= 27% against H1: ORR \> 27% for Cohort 2.||||||0.025|||||||Exact Test|||||||0.025
71676491|NCT02060058|142870848|OTHER|The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.||||||0.01|||||||Chi-squared|||||||0.01
71676492|NCT04532619|142870851|SUPERIORITY||Slope|0.5||||0.014|TWO_SIDED|95.0|0.1|0.89||Computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.89|0.10|0.014
71676493|NCT04532619|142870852|SUPERIORITY||Slope|-0.05||||0.8|TWO_SIDED|95.0|-0.41|0.32||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.32|-0.41|0.80
71810247|NCT04393441|143122105|NON_INFERIORITY|MMRM with fixed effects=treatment, visit, visit by treatment interaction,Baseline total staining stratum(TSS),and Baseline TSS by visit interaction.|Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.57||0.0475|TWO_SIDED|95.0|0.01|2.27|||MMRM|||Change from Baseline in Total Staining Score at Day 90: The null hypothesis was that 011516X tear formulation was to be considered noninferior to Systane Ultra MD if the upper limit of 2-sided confidence interval (CI) was less than 2.3 units.||2.27|0.01|0.0475
71810248|NCT04393441|143122106|OTHER|No formal hypothesis was planned. The p-value for treatment differences is reported for reference.|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|16.32||0.9001|TWO_SIDED|95.0|-30.03|34.14|||MMRM|MMRM with fixed effects=treatment, visit, visit by treatment interaction, Baseline TSS, and Baseline TSS by visit interaction.||||34.14|-30.03|0.9001
71895380|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.42|||||TWO_SIDED|80.0|-0.1|6.94||||||Compared with Baseline (Pre-dinner)||6.94|-0.10|
71676494|NCT04532619|142870853|SUPERIORITY||Slope|-0.29||||0.009|TWO_SIDED|95.0|-0.51|-0.07||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||-0.07|-0.51|0.009
71676495|NCT04532619|142870854|SUPERIORITY||Slope|0.17||||0.118|TWO_SIDED|95.0|-0.04|0.38||calculated p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.38|-0.04|0.118
71810249|NCT01812655|143122107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.7||||0.029|TWO_SIDED|95.0|2.4|45.0|||Regression, Linear||Mean difference = PD group - VR group|||45.0|2.4|0.029
71810250|NCT01812655|143122107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7||||0.32|TWO_SIDED|95.0|-9.5|28.9|||Regression, Linear||Mean difference = VR group - SC group|||28.9|-9.5|0.32
71810251|NCT01812655|143122108|SUPERIORITY_OR_OTHER||Semipartial correlation|0.223||||0.26||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC State Anxiety measured at Baseline for all participants|||||.26
71810252|NCT01812655|143122108|SUPERIORITY_OR_OTHER||Semipartial correlation|0.119||||0.59||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||.59
71844035|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-1.4|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||1.2|-1.4|
71895381|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|||||TWO_SIDED|80.0|-8.42|0.18||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||0.18|-8.42|
71810253|NCT01812655|143122108|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.059||||0.6||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants|||||.60
71810254|NCT01812655|143122109|SUPERIORITY_OR_OTHER||semipartial correlation|-0.276||||0.15||95.0|||||Semipartial Correlation||Semipartial correlation between Engagement with Distraction and STAIC State Anxiety measured at Baseline for all participants|||||0.15
71810255|NCT01812655|143122109|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.347||||0.18||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants|||||0.18
71810256|NCT01812655|143122109|SUPERIORITY_OR_OTHER||Semipartial correlation|0.21||||0.054||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants|||||0.054
71810257|NCT01812655|143122109|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.102||||0.61||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants|||||0.61
71844036|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.7|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||1.2|-1.7|
71895382|NCT01933672|143313084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|||||TWO_SIDED|80.0|-2.6|5.89||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.||5.89|-2.60|
71895383|NCT01933672|143313087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|||||TWO_SIDED|80.0|0.21|1.39||||||Compared with baseline||1.39|0.21|
71810258|NCT01812655|143122109|SUPERIORITY_OR_OTHER||Semipartial Correlation|-0.622||||0.007||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants|||||0.007
71810259|NCT01812655|143122109|SUPERIORITY_OR_OTHER||Semipartial correlation|-0.217||||0.045||95.0|||||Semipartial correlation||Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants|||||0.045
71810260|NCT01786967|143122122|SUPERIORITY|This was a pilot study to provide preliminary data to inform future sample size estimates for a larger more definitive trial|Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.53|1.71|||Fisher Exact|||Null hypothesis was that there will be no difference in treatment benefit scale between the two groups||1.71|0.53|1.0
71810261|NCT01786967|143122123|SUPERIORITY||Risk Ratio (RR)|0.85||||1|TWO_SIDED|95.0|0.76|0.95|||Fisher Exact|||Null hypothesis was that there was no difference in the rate of moderate to severe adverse events.||.95|.76|1.0
71810262|NCT04557930|143122124|SUPERIORITY||Odds Ratio (OR)|0.96||||0.41|TWO_SIDED|95.0|0.88|1.06|||Mixed Models Analysis|||We tested the association between exposure to the intervention and the incidence of ACP billing in the pre- and post-intervention periods using a mixed effects logistic regression model, adjusting for time, patient and hospital covariates.||1.06|0.88|0.41
71810263|NCT04557930|143122124|SUPERIORITY|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Odds Ratio (OR)|1.03||||0.74|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|Overall effect allowing effect heterogeneity across steps \<0.001 Interaction effect \<0.001|Step 1 cohort|||1.19|0.89|0.74
71810264|NCT04557930|143122124|SUPERIORITY||Odds Ratio (OR)|1.15||||0.09|TWO_SIDED|95.0|0.98|1.36|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 2 cohort|1.36|0.98|0.09
71844037|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.8|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||1.2|-1.8|
71895384|NCT01933672|143313087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|80.0|-0.43|0.93||||||Compared with baseline||0.93|-0.43|
71895385|NCT01933672|143313087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|||||TWO_SIDED|80.0|-0.92|0.4||||||Compared with baseline||0.40|-0.92|
71810265|NCT04557930|143122124|SUPERIORITY||Odds Ratio (OR)|1.13||||0.11|TWO_SIDED|95.0|0.97|1.33|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 3 cohort|1.33|0.97|0.11
71810266|NCT04557930|143122124|SUPERIORITY||Odds Ratio (OR)|0.66|||<|0.001|TWO_SIDED|95.0|0.57|0.76|||Mixed Models Analysis||Step 4 cohort|Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.||0.76|0.57|<0.001
71810267|NCT04557930|143122124|SUPERIORITY||Odds Ratio (OR)|0.95||||0.49|TWO_SIDED|95.0|0.89|1.19|||Mixed Models Analysis|||Sensitivity analysis of the association between the intervention and ACP billing, adjusted for time, patient characteristics, hospital characteristics, and the interaction between step of the trial and the intervention.|Step 5 cohort|1.19|0.89|0.49
71810268|NCT05725317|143122157|NON_INFERIORITY|Noninferiority in distance visual acuity was declared if the upper confidence limit was less than 0.05.|LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens-by-visit interaction and sequence) and random (subject) effects. Difference = LID220365 minus LID006961. Sign is retained with the rounded value.|||0.00||
71810269|NCT03063294|143122164|SUPERIORITY||Difference in Difference|0.02|||||TWO_SIDED|95.0|-0.47|0.5|||||"The difference in difference equals the follow-up minus baseline change in Hassles scale results for the toolkit plus coaching clinics, minus the follow-up minus baseline change in the Hassles scale results for the toolkit only clinics."|"Zero-inflated negative binomial regression was used to obtain predicted mean Hassles scale scores for the toolkit only clinics and toolkit plus coaching clinics at baseline and follow-up, adjusting for study design and characteristics of survey respondents. The difference-in-difference was then computed as described below, under method of estimation. Bootstrap resampling was used to calculate the 95% confidence intervals around the predicted means and the difference-in-difference."||0.50|-0.47|
71810270|NCT02460692|143122197|SUPERIORITY|||||||0.78||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||This is the primary comparison.||||0.78
71810271|NCT02460692|143122197|SUPERIORITY|||||||0.07||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is the secondary comparison.||||0.070
71810272|NCT02460692|143122197|SUPERIORITY|||||||0.044||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||This is an exploratory comparison||||0.044
71810273|NCT02460692|143122198|SUPERIORITY|||||||0.27||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.27
71810274|NCT02460692|143122198|SUPERIORITY|||||||0.96||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.96
71844038|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||1.6|-1.5|
71844039|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.8|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||1.5|-1.8|
71810275|NCT02460692|143122198|SUPERIORITY|||||||0.3||||||The average change of impact scores at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.30
71810276|NCT02460692|143122199|SUPERIORITY|||||||0.44||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.44
71810277|NCT02460692|143122199|SUPERIORITY|||||||0.53||||||The average pain change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.53
71810278|NCT02460692|143122199|SUPERIORITY|||||||0.18||||||The average NPS change at the treatment period (weeks 5-8) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect|Unstructured covariance model|||||||0.18
71810279|NCT02460692|143122200|SUPERIORITY|||||||0.95||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.95
71810280|NCT02460692|143122200|SUPERIORITY|||||||0.94||||||The average change of learning scores at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.94
71810281|NCT02460692|143122200|SUPERIORITY|||||||0.9||||||The average change of learning score at the treatment period (weeks 5-8) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||.90
71810282|NCT02460692|143122201|SUPERIORITY|||||||0.93||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8 at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.93
71844040|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-1.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||2.1|-1.1|
71895386|NCT01933672|143313087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|||||TWO_SIDED|80.0|0.17|1.95||||||||1.95|0.17|
71810283|NCT02460692|143122201|SUPERIORITY|||||||0.92||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.92
71810284|NCT02460692|143122201|SUPERIORITY|||||||0.85||||||The average change of total time completing task in grooved pegboard test on dominant hand (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.85
71810285|NCT02460692|143122202|SUPERIORITY|||||||0.89||||||The average change in Wechsler Adult Intelligence Scale (WAIS)-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model.|Unstructured covariance model|||||||0.89
71895387|NCT01933672|143313087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|||||TWO_SIDED|80.0|-0.45|1.47||||||||1.47|-0.45|
71895388|NCT00524303|143313118|SUPERIORITY_OR_OTHER||Percent difference|-9.0|||||TWO_SIDED|95.0|-38.1|17.9|||||Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.|||17.9|-38.1|
71895389|NCT00524303|143313118|SUPERIORITY_OR_OTHER||Percent difference|20.0|||||TWO_SIDED|95.0|-8.0|49.4|||||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||49.4|-8.0|
71810286|NCT02460692|143122202|SUPERIORITY|||||||0.13||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.13
71810287|NCT02460692|143122202|SUPERIORITY|||||||0.14||||||The average change in WAIS-III test score (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model|unstructured covariance model|||||||0.14
71810288|NCT02460692|143122203|SUPERIORITY|||||||0.1||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|Unstructured covariance model|||||||0.10
71810289|NCT02460692|143122203|SUPERIORITY|||||||0.67||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.67
71810290|NCT02460692|143122203|SUPERIORITY|||||||0.25||||||The average change of total mood disturbance scores (weeks 5-8, at the treatment period) from baseline were compared between the two arms using an unstructured covariance model, excluding main group effect.|unstructured covariance model|||||||0.25
71810291|NCT02460692|143122204|SUPERIORITY|||||||0.84||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.84
71813795|NCT02799472|143129760|OTHER||Ratio|1.581||||0.031|TWO_SIDED|95.0|1.046|2.388|||Repeated measures analysis|||ARGS Neo-Epitope, Week 2||2.388|1.046|0.031
71813796|NCT02799472|143129760|OTHER||Ratio|1.222||||0.317|TWO_SIDED|95.0|0.817|1.827|||Repeated measures analysis|||ARGS Neo-Epitope, Week 4||1.827|0.817|0.317
71813797|NCT02799472|143129760|OTHER||Ratio|1.302||||0.113|TWO_SIDED|95.0|0.936|1.81|||Repeated measures analysis|||ARGS Neo-Epitope, Week 6||1.810|0.936|0.113
71813798|NCT02799472|143129760|OTHER||Ratio|1.45||||0.217|TWO_SIDED|95.0|0.795|2.645|||Repeated measures analysis|||ARGS Neo-Epitope, Week 8||2.645|0.795|0.217
71813799|NCT02799472|143129760|OTHER||Ratio|1.266||||0.147|TWO_SIDED|95.0|0.916|1.75|||Repeated measures analysis|||ARGS Neo-Epitope, Week 12||1.750|0.916|0.147
71813800|NCT02799472|143129760|OTHER||Ratio|0.996||||0.985|TWO_SIDED|95.0|0.662|1.499|||Repeated measures analysis|||ARGS Neo-Epitope, 12-Week FU||1.499|0.662|0.985
71813801|NCT02799472|143129760|OTHER||Ratio|0.892||||0.681|TWO_SIDED|95.0|0.511|1.56|||Repeated measures analysis|||CMDV, Week 1||1.560|0.511|0.681
71813802|NCT02799472|143129760|OTHER||Ratio|0.87||||0.668|TWO_SIDED|95.0|0.454|1.669|||Repeated measures analysis|||CMDV, Week 2||1.669|0.454|0.668
71813803|NCT02799472|143129760|OTHER||Ratio|1.12||||0.717|TWO_SIDED|95.0|0.597|2.101|||Repeated measures analysis|||CMDV, Week 4||2.101|0.597|0.717
71813804|NCT02799472|143129760|OTHER||Ratio|0.661||||0.227|TWO_SIDED|95.0|0.333|1.31|||Repeated measures analysis|||CMDV, Week 6||1.310|0.333|0.227
71813805|NCT02799472|143129760|OTHER||Ratio|0.817||||0.471|TWO_SIDED|95.0|0.464|1.437|||Repeated measures analysis|||CMDV, Week 8||1.437|0.464|0.471
71813806|NCT02799472|143129760|OTHER||Ratio|0.816||||0.541|TWO_SIDED|95.0|0.417|1.597|||Repeated measures analysis|||CMDV, Week 12||1.597|0.417|0.541
71813807|NCT02799472|143129760|OTHER||Ratio|0.822||||0.544|TWO_SIDED|95.0|0.422|1.602|||Repeated measures analysis|||CMDV, 12-Week FU||1.602|0.422|0.544
71813808|NCT02799472|143129760|OTHER||Ratio|1.051||||0.537|TWO_SIDED|95.0|0.895|1.233|||Repeated measures analysis|||MMP-Degraded CRP, Week 1||1.233|0.895|0.537
71813809|NCT02799472|143129760|OTHER||Ratio|1.031||||0.635|TWO_SIDED|95.0|0.906|1.173|||Repeated measures analysis|||MMP-Degraded CRP, Week 2||1.173|0.906|0.635
71813810|NCT02799472|143129760|OTHER||Ratio|1.012||||0.866|TWO_SIDED|95.0|0.879|1.165|||Repeated measures analysis|||MMP-Degraded CRP, Week 4||1.165|0.879|0.866
71813811|NCT02799472|143129760|OTHER||Ratio|0.979||||0.78|TWO_SIDED|95.0|0.842|1.139|||Repeated measures analysis|||MMP-Degraded CRP, Week 6||1.139|0.842|0.780
71813812|NCT02799472|143129760|OTHER||Ratio|1.113||||0.212|TWO_SIDED|95.0|0.938|1.32|||Repeated measures analysis|||MMP-Degraded CRP, Week 8||1.320|0.938|0.212
71813813|NCT02799472|143129760|OTHER||Ratio|1.102||||0.242|TWO_SIDED|95.0|0.934|1.3|||Repeated measures analysis|||MMP-Degraded CRP, Week 12||1.300|0.934|0.242
71813814|NCT02799472|143129760|OTHER||Ratio|1.05||||0.597|TWO_SIDED|95.0|0.87|1.267|||Repeated measures analysis|||MMP-Degraded CRP, 12-Week FU||1.267|0.870|0.597
71813815|NCT02799472|143129760|OTHER||Ratio|0.795||||0.047|TWO_SIDED|95.0|0.634|0.997|||Repeated measures analysis|||MD1C, Week 1||0.997|0.634|0.047
71813816|NCT02799472|143129760|OTHER||Ratio|0.883||||0.367|TWO_SIDED|95.0|0.668|1.165|||Repeated measures analysis|||MD1C, Week 2||1.165|0.668|0.367
71813817|NCT02799472|143129760|OTHER||Ratio|0.784||||0.155|TWO_SIDED|95.0|0.558|1.102|||Repeated measures analysis|||MD1C, Week 4||1.102|0.558|0.155
71813818|NCT02799472|143129760|OTHER||Ratio|0.638||||0.004|TWO_SIDED|95.0|0.477|0.855|||Repeated measures analysis|||MD1C, Week 6||0.855|0.477|0.004
71813819|NCT02799472|143129760|OTHER||Ratio|0.799||||0.14|TWO_SIDED|95.0|0.591|1.08|||Repeated measures analysis|||MD1C, Week 8||1.080|0.591|0.140
71813820|NCT02799472|143129760|OTHER||Ratio|0.891||||0.47|TWO_SIDED|95.0|0.647|1.228|||Repeated measures analysis|||MD1C, Week 12||1.228|0.647|0.470
71813821|NCT02799472|143129760|OTHER||Ratio|0.869||||0.401|TWO_SIDED|95.0|0.621|1.217|||Repeated measures analysis|||MD1C, 12-Week FU||1.217|0.621|0.401
71813822|NCT02799472|143129760|OTHER||Ratio|0.981||||0.887|TWO_SIDED|95.0|0.742|1.296|||Repeated measures analysis|||MD2C, Week 1||1.296|0.742|0.887
71813823|NCT02799472|143129760|OTHER||Ratio|0.97||||0.814|TWO_SIDED|95.0|0.744|1.263|||Repeated measures analysis|||MD2C, Week 2||1.263|0.744|0.814
71810292|NCT02460692|143122204|SUPERIORITY|||||||0.91||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.91
71810293|NCT02460692|143122204|SUPERIORITY|||||||0.75||||||The average change of beck score (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model, excluding main group effect|unstructured covariance model|||||||0.75
71810294|NCT02460692|143122205|SUPERIORITY|||||||0.24||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.24
71810295|NCT02460692|143122205|SUPERIORITY|||||||0.08||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.080
71810296|NCT02460692|143122205|SUPERIORITY|||||||0.005||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.005
71810297|NCT02460692|143122206|SUPERIORITY|||||||0.6|||||||unstructured covariance model|||||||0.60
71810298|NCT02460692|143122206|SUPERIORITY|||||||0.4|||||||unstructured covariance model|||||||0.40
71810299|NCT02460692|143122206|SUPERIORITY|||||||0.72|||||||unstructured covariance model|||||||0.72
71810300|NCT02460692|143122207|SUPERIORITY|||||||0.19||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.19
71810301|NCT02460692|143122207|SUPERIORITY|||||||0.7||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.70
71810302|NCT02460692|143122207|SUPERIORITY|||||||0.36||||||The average change of pain sensitivity (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.36
71810303|NCT02460692|143122208|SUPERIORITY|||||||0.14|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.14
71810304|NCT02460692|143122208|SUPERIORITY|||||||0.6|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.60
71810305|NCT02460692|143122208|SUPERIORITY|||||||0.34|||||||Regression, Linear|||Change in withdrawal intensity from week 8 to week 10 was compared between the two arms.||||.34
71810306|NCT02460692|143122209|SUPERIORITY|||||||0.34|||||||unstructured covariance model|||||||0.34
71810307|NCT02460692|143122209|SUPERIORITY|||||||0.007|||||||unstructured covariance model|||||||0.007
71810308|NCT02460692|143122209|SUPERIORITY|||||||0.055|||||||unstructured covariance model|||||||0.055
71810309|NCT02460692|143122210|SUPERIORITY|||||||0.69|||||||unstructured covariance model|||||||0.69
71810310|NCT02460692|143122210|SUPERIORITY|||||||0.79|||||||unstructured covariance model|||||||0.79
71844041|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.2|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||1.0|-2.2|
71844042|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.2|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||1.2|-2.2|
71810311|NCT02460692|143122210|SUPERIORITY|||||||0.97|||||||unstructured covariance model|||||||0.97
71810312|NCT02460692|143122211|SUPERIORITY|||||||0.21||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.21
71810313|NCT02460692|143122211|SUPERIORITY|||||||0.029||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.029
71810314|NCT02460692|143122211|SUPERIORITY|||||||0.001||||||Area under the time concentration curve (AUC) was calculated as the aggregate effect of response and compared between the arms.|Regression, Linear|||||||0.001
71810315|NCT02460692|143122212|SUPERIORITY|||||||0.084|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.084
71810316|NCT02460692|143122212|SUPERIORITY|||||||0.98|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.98
71810317|NCT02460692|143122212|SUPERIORITY|||||||0.085|||||||Regression, Linear|||Change in negative impact of withdrawal from week 8 to week 10 was compared between the two arms.||||0.085
71810318|NCT02460692|143122213|SUPERIORITY|||||||0.95||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model|unstructured covariance model|||||||0.95
71810319|NCT02460692|143122213|SUPERIORITY|||||||0.78||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.78
71810320|NCT02460692|143122213|SUPERIORITY|||||||0.99||||||The average change of pain tolerance (weeks 5-8 at the treatment period) from baseline were compared between the arms using an unstructured covariance model.|unstructured covariance model|||||||0.99
71810321|NCT02276222|143122237|SUPERIORITY||Least Squares Mean (SE)|0.0084|STANDARD_ERROR_OF_MEAN|0.01012||0.4041|TWO_SIDED|95.0|-0.0114|0.0283|||ANCOVA|||||0.0283|-0.0114|0.4041
71810322|NCT01971723|143122238|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|Groups were compared against each other at the two different time points and against themselves at the same time points.||This statistical analysis is for the squat one repetition maximum outcomes, only.||||.38
71810323|NCT01971723|143122238|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis is for the bench press one repetition maximum outcomes, only.||||0.0001
71810324|NCT01971723|143122238|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||ANOVA|||This statistical analysis is for the deadlift one repetition maximum measures, only.||||.3
71810325|NCT01971723|143122238|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||This statistical analysis compares the outcomes of the total weight lifted.||||0.0001
71895390|NCT00524303|143313119|SUPERIORITY_OR_OTHER||Percent Difference|7.0||||0.627|TWO_SIDED|95.0|-17.8|32.5|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.|||32.5|-17.8|0.627
71895391|NCT00524303|143313119|SUPERIORITY_OR_OTHER||Percent Difference|0.0||||1|TWO_SIDED|95.0|-25.1|25.1|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.|||25.1|-25.1|1.000
71895392|NCT01676116|143313179|SUPERIORITY_OR_OTHER||Treatment contrast|-0.94|||<|0.001|TWO_SIDED|95.0|-1.11|-0.78|||ANCOVA|||||-0.78|-1.11|<0.001
71895393|NCT02680301|143313208|EQUIVALENCE|Wilcoxon sign- rank test values with ranks from change in cream efficacy ratings minus change in ointment efficacy ratings.||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71895394|NCT00095121|143313211|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||End of double-blind treatment|Fisher Exact|||After unblinding the results, due to the small number of responders in the placebo group, it was determined that a statistical exact test would be more appropriate in the evaluation of treatment group differences than the originally planned 95% confidence intervals of the difference between the groups. Therefore, the results were analyzed by study visit, and a Fisher exact test was used to evaluate treatment differences between the adefovir dipivoxil and placebo groups.||||<0.001
71895395|NCT00095121|143313227|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Loss|Fisher Exact|||||||0.051
71895396|NCT00095121|143313227|SUPERIORITY_OR_OTHER|||||||0.051||||||Comparison of HBeAg Seroconversion|Fisher Exact|||||||0.051
71895397|NCT01225068|143313297|SUPERIORITY_OR_OTHER||effect size|0.22||||||||||no p value for effect size calculations ES is dimensionless; ES (Cohen's d) is a well described statistical construct and is calculated from the difference between the means (here at baseline and 6 weeks) divided by the pooled standard deviation.|effect size is endpoint and not comparis|no p value for effect size calculations||effect size is endpoint and not comparison||||
71895398|NCT02031146|143313331|OTHER|||||||0.29|||||||Two sample test of proportion in Stata|||||||0.29
71895399|NCT02031146|143313332|OTHER|||||||0.69|||||||Log Rank|||||||0.69
71895400|NCT02031146|143313333|OTHER|||||||0.04|||||||Log Rank|||||||0.04
71895401|NCT03167619|143313368|SUPERIORITY||MLE assuming exponential distribution|0.18||||0.0023|TWO_SIDED|95.0|0.11|0.27|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.27|0.11|0.0023
71895402|NCT03167619|143313369|SUPERIORITY||MLE assuming exponential distribution|0.11|||<|0.0001|TWO_SIDED|95.0|0.07|0.19|||Chi-squared|Comparison to mean of historical control|Presence of patients with long PFS may have violated exponential assumption.|Assumed median PFS = 2.0 months as historical control, transformed to rate of 0.35/month||0.19|0.07|<0.0001
71895403|NCT02767570|143313390|SUPERIORITY||Mean Difference (Net)|-1.2||||0.001|TWO_SIDED|95.0|-1.9|-0.5||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|For the primary hypothesis that there would be a greater reduction in pain for the altered compared to the consistent FPA group, an effect size of 0.57 was assumed. To achieve 80% power with an alpha of 0.05, 39 participants per group were needed, so our recruitment goal was 40 subjects per group.||-0.5|-1.9|0.001
71895404|NCT02767570|143313391|SUPERIORITY||Mean Difference (Net)|-0.26|||<|0.001|TWO_SIDED|95.0|-0.39|-0.13||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-0.13|-0.39|<0.001
71895405|NCT02767570|143313392|SUPERIORITY||Mean Difference (Net)|-3.74||||0.006|TWO_SIDED|95.0|-6.42|-1.05||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||-1.05|-6.42|0.006
71810326|NCT01971723|143122239|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810327|NCT01971723|143122240|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical measurement is for cholesterol measure outcomes, only.||||>.05
71810328|NCT01971723|143122240|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for glucose measure outcomes, only.||||>.05
71810329|NCT01971723|143122240|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for HDL measure outcomes, only.||||>.05
71810330|NCT01971723|143122240|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for LDL measure outcomes, only.||||>.05
71810331|NCT01971723|143122240|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis for the triglyceride measure outcomes, only.||||>.05
71810332|NCT01971723|143122241|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810333|NCT01971723|143122242|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810334|NCT01971723|143122243|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810335|NCT01971723|143122244|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810336|NCT01971723|143122245|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71895406|NCT02767570|143313393|SUPERIORITY||Mean Difference (Net)|-0.06||||0.93|TWO_SIDED|95.0|-1.42|1.3||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||1.30|-1.42|0.93
71810337|NCT01971723|143122246|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>.05
71810338|NCT01971723|143122247|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for deadlift volume measure outcomes, only.||||>.05
71810339|NCT01971723|143122247|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for auxiliary squat volume measure outcomes, only.||||>.05
71810340|NCT01971723|143122247|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||This statistical analysis is for squat volume measure outcomes, only.||||>.05
71810341|NCT01971723|143122247|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for bench volume measure outcomes, only.||||>.05
71810342|NCT01971723|143122247|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total squat volume measures, only.||||>.05
71810343|NCT01971723|143122247|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis is for total weight lifted volume measure outcomes, only.||||>.05
71810344|NCT01971723|143122248|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810345|NCT01971723|143122249|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71810346|NCT01971723|143122250|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
71810347|NCT05899686|143122251|EQUIVALENCE|Equivalence was defined as ANOVA p\<0.05||||||0.65|||||||ANOVA|||Maximum percent change from baseline (light transmittance) during 60 heart beats after the tetanic stimulus were compared between the three stimulus locations using ANOVA||||0.65
71810348|NCT00902694|143122258|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.6|-0.4||||||6 month intervention versus control||-0.4|-2.6|
71810349|NCT00902694|143122258|SUPERIORITY||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-5.1|-1.2||||||18 month intervention versus control||-1.2|-5.1|
71810350|NCT00902694|143122260|SUPERIORITY||Mean Difference (Net)|-2.0|||||TWO_SIDED|95.0|-3.6|-0.4||||||6 month intervention versus control||-0.4|-3.6|
71810351|NCT00902694|143122260|SUPERIORITY||Mean Difference (Net)|-1.9|||||TWO_SIDED|95.0|-4.1|0.3||||||18 month intervention versus control||0.3|-4.1|
71810352|NCT00902694|143122261|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-3.2|2.4||||||6 month systolic intervention versus control||2.4|-3.2|
71810353|NCT00902694|143122261|SUPERIORITY||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.6|2.1||||||6 month diastolic intervention versus control||2.1|-1.6|
71810354|NCT00902694|143122261|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.6|4.8||||||18 month systolic intervention versus control||4.8|-1.6|
71810355|NCT00902694|143122261|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-0.9|3.4||||||18 month diastolic intervention versus control||3.4|-0.9|
71810356|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-2.9|||||TWO_SIDED|95.0|-9.9|4.1||||||6 month total chol intervention versus control||4.1|-9.9|
71810357|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|95.0|-14.9|4.4||||||18 month total chol intervention versus control||4.4|-14.9|
71810358|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-7.5|5.1||||||6 month LDL chol intervention versus control||5.1|-7.5|
71810359|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-4.6|||||TWO_SIDED|95.0|-13.1|3.9||||||18 month LDL chol intervention versus control||3.9|-13.1|
71810360|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7||||||6 month HDL chol intervention versus control||1.7|-2.9|
71810361|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-1.8|3.1||||||18 month HDL intervention versus control||3.1|-1.8|
71810362|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-5.5|||||TWO_SIDED|95.0|-23.5|12.4||||||6 month TRIG intervention versus control||12.4|-23.5|
71810363|NCT00902694|143122262|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-27.0|23.9||||||18 month TRIG intervention versus control||23.9|-27.0|
71810364|NCT04450108|143122273|SUPERIORITY|The change of FeNO values will be estimated in ANCOVA with baseline values as the covariable and will be reported as percent change together with the 95%-confidence interval.|||||<|0.001|||||||ANCOVA|||Since the effect size of the change (mean change / standard deviation) is on the order of 1 (resulting in N=10 and 13 for power = 80% and 90%, respectively) and therefore large, the sample size is not determined by the primary objective but by the necessity to achieve representative data of FeNO measurement data over all age groups, measurement ranges (\<, ≥ cut off) and sites. Thus, 120 subjects will be recruited.||||<0.001
71810365|NCT01024608|143122279|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.91|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05.|ANCOVA|Repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
71810366|NCT01024608|143122280|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.92|||<|0.001|TWO_SIDED|95.0|-1.3|-0.5||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||||-0.5|-1.3|<0.001
71810367|NCT01024608|143122281|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.48||||0.005|TWO_SIDED|95.0|-0.8|-0.1||A priori threshold for statistical significance is p\<0.05|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||||-0.1|-0.8|0.005
71810368|NCT01024608|143122282|SUPERIORITY_OR_OTHER_LEGACY||LS mean treatment diff from placebo|-0.56||||0.002|TWO_SIDED|95.0|-0.9|-0.2||A priori threshold for statistical significance is p\<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction||||-0.2|-0.9|0.002
71810369|NCT04922554|143122335|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|14.15||||0.2182|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.2182
71810370|NCT04922554|143122336|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in response rates|22.15||||0.046|TWO_SIDED|||||Nominal p-values are provided for descriptive purposes.|Chi-squared|Analysis stratified by prior NTM antibiotic treatment was not performed due to small sample size in one randomization stratification subgroup.||||||0.0460
71810371|NCT04922554|143122345|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.8||||0.824|TWO_SIDED|95.0|-6.01|7.52||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||7.52|-6.01|0.8240
71810372|NCT04922554|143122346|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.1||||0.2149|TWO_SIDED|95.0|-3.03|13.2||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.20|-3.03|0.2149
71810373|NCT04922554|143122347|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|8.3||||0.123|TWO_SIDED|95.0|-2.31|18.88||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||18.88|-2.31|0.1230
71810374|NCT04922554|143122348|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|5.5||||0.1168|TWO_SIDED|95.0|-1.41|12.43||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||12.43|-1.41|0.1168
71810375|NCT04922554|143122349|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|6.5||||0.0743|TWO_SIDED|95.0|-0.66|13.66||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||13.66|-0.66|0.0743
71810376|NCT04922554|143122350|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|7.1||||0.0899|TWO_SIDED|95.0|-1.13|15.23||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||15.23|-1.13|0.0899
71810377|NCT04922554|143122351|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.5||||0.9019|TWO_SIDED|95.0|-7.6|8.59||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||8.59|-7.60|0.9019
71810378|NCT04922554|143122352|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|13.7||||0.0015|TWO_SIDED|95.0|5.43|21.89||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||21.89|5.43|0.0015
71810379|NCT04922554|143122353|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|0.9||||0.8269|TWO_SIDED|95.0|-7.26|9.05||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison of Omadacycline and Placebo for activity score has been presented.|||9.05|-7.26|0.8269
71810380|NCT04922554|143122353|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.2||||0.9584|TWO_SIDED|95.0|-7.74|7.35||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for impact score has been presented|||7.35|-7.74|0.9584
71810381|NCT04922554|143122353|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.0||||0.2123|TWO_SIDED|95.0|-12.88|2.92||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for symptom score has been presented.|||2.92|-12.88|0.2123
71810382|NCT04922554|143122353|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-0.8||||0.8161|TWO_SIDED|95.0|-7.58|5.99||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA||Treatment comparison between Omadacycline and Placebo for total score has been presented.|||5.99|-7.58|0.8161
71810383|NCT04922554|143122354|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Least square mean difference|-5.7||||0.001|TWO_SIDED|95.0|-8.95|-2.38||ANCOVA analyzed change from baseline using treatment, prior antibiotic use, and baseline score as factors. LS mean difference = Omadacycline minus Placebo.|ANCOVA|||||-2.38|-8.95|0.0010
71810384|NCT04922554|143122355|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|39.61||||0.002|TWO_SIDED|95.0|16.66|62.56|||Fisher Exact|||||62.56|16.66|0.0020
71810385|NCT04922554|143122356|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Difference in improvement rates|15.41||||0.3051|TWO_SIDED|95.0|-9.1|39.93|||Fisher Exact|||||39.93|-9.10|0.3051
71810386|NCT04922554|143122357|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.3552|||||||Wilcoxon rank sum test|||||||0.3552
71810387|NCT04922554|143122358|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0753|||||||Wilcoxon rank sum test|||||||0.0753
71810388|NCT04922554|143122360|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.|Odds Ratio (OR)|3.84||||0.0168|TWO_SIDED|95.0|1.24|11.87|||Chi-squared|||||11.87|1.24|0.0168
71810389|NCT04922554|143122361|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0233|||||||Log Rank|||||||0.0233
71810390|NCT04922554|143122362|OTHER|Endpoints are summarized using descriptive statistics. Inferential testing of pre-specified hypothesis was not completed.||||||0.0349|||||||Log Rank|||||||0.0349
71810391|NCT03896009|143122372|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71810392|NCT03896009|143122373|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71810393|NCT02052310|143122399|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.053||0.0005|TWO_SIDED|95.0|0.079|0.287|||ANCOVA|ANCOVA with multiple imputation||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.287|0.079|0.0005
71813824|NCT02799472|143129760|OTHER||Ratio|0.969||||0.794|TWO_SIDED|95.0|0.762|1.233|||Repeated measures analysis|||MD2C, Week 4||1.233|0.762|0.794
71813825|NCT02799472|143129760|OTHER||Ratio|0.919||||0.539|TWO_SIDED|95.0|0.696|1.213|||Repeated measures analysis|||MD2C, Week 6||1.213|0.696|0.539
71813826|NCT02799472|143129760|OTHER||Ratio|0.937||||0.623|TWO_SIDED|95.0|0.719|1.221|||Repeated measures analysis|||MD2C, Week 8||1.221|0.719|0.623
71895407|NCT02767570|143313394|SUPERIORITY||Mean Difference (Net)|-0.29||||0.85|TWO_SIDED|95.0|-3.38|2.8||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||2.80|-3.38|0.85
71895408|NCT02767570|143313395|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-0.89|0.9||The threshold for statistical significance was p=0.05.|Regression, Linear||Difference = Altered FPA - Consistent FPA|||0.90|-0.89|0.99
71810394|NCT02052310|143122400|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|3.5|||||TWO_SIDED|95.0|-0.7|7.7||||||For the difference of responder rates between 2 treatment groups, the CI was analyzed from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||7.7|-0.7|
71895409|NCT00151411|143313396|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.54|TWO_SIDED|95.0|-9.9|18.4|||Mixed Models Analysis|||||18.4|-9.9|0.54
71895410|NCT00151411|143313397|SUPERIORITY||Rate Ratio|2.5||||0.07|TWO_SIDED|95.0|0.9|6.6|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the probability of ovulation.||6.6|0.9|0.07
71813827|NCT02799472|143129760|OTHER||Ratio|0.913||||0.467|TWO_SIDED|95.0|0.711|1.173|||Repeated measures analysis|||MD2C, Week 12||1.173|0.711|0.467
71813828|NCT02799472|143129760|OTHER||Ratio|0.778||||0.108|TWO_SIDED|95.0|0.57|1.061|||Repeated measures analysis|||MD2C, 12-Week FU||1.061|0.570|0.108
71813829|NCT02799472|143129760|OTHER||Ratio|1.01||||0.897|TWO_SIDED|95.0|0.868|1.175|||Repeated measures analysis|||MD3C, Week 1||1.175|0.868|0.897
71813830|NCT02799472|143129760|OTHER||Ratio|1.037||||0.644|TWO_SIDED|95.0|0.884|1.218|||Repeated measures analysis|||MD3C, Week 2||1.218|0.884|0.644
71813831|NCT02799472|143129760|OTHER||Ratio|0.943||||0.53|TWO_SIDED|95.0|0.78|1.139|||Repeated measures analysis|||MD3C, Week 4||1.139|0.780|0.530
71813832|NCT02799472|143129760|OTHER||Ratio|0.882||||0.182|TWO_SIDED|95.0|0.733|1.063|||Repeated measures analysis|||MD3C, Week 6||1.063|0.733|0.182
71813833|NCT02799472|143129760|OTHER||Ratio|0.96||||0.691|TWO_SIDED|10.0|0.779|1.182|||Repeated measures analysis|||MD3C, Week 8||1.182|0.779|0.691
71813834|NCT02799472|143129760|OTHER||Ratio|0.979||||0.843|TWO_SIDED|95.0|0.79|1.214|||Repeated measures analysis|||MD3C, Week 12||1.214|0.790|0.843
71813835|NCT02799472|143129760|OTHER||Ratio|1.075||||0.524|TWO_SIDED|95.0|0.855|1.351|||Repeated measures analysis|||MD3C, 12-Week FU||1.351|0.855|0.524
71813836|NCT02799472|143129761|OTHER||Ratio|0.953||||0.558|TWO_SIDED|95.0|0.809|1.123|||Repeated measures analysis|||Helper/Suppressor, Week 1||1.123|0.809|0.558
71813837|NCT02799472|143129761|OTHER||Ratio|0.947||||0.515|TWO_SIDED|95.0|0.801|1.12|||Repeated measures analysis|||Helper/Suppressor, Week 4||1.120|0.801|0.515
71813838|NCT02799472|143129761|OTHER||Ratio|1.046||||0.565|TWO_SIDED|95.0|0.895|1.222|||Repeated measures analysis|||Helper/Suppressor, Week 12||1.222|0.895|0.565
71813839|NCT02799472|143129761|OTHER||Ratio|1.013||||0.897|TWO_SIDED|95.0|0.822|1.249|||Repeated measures analysis|||Helper/Suppressor, 12-Week FU||1.249|0.822|0.897
71813840|NCT02799472|143129762|OTHER||Ratio|1.037||||0.786|TWO_SIDED|95.0|0.794|1.354|||Repeated measures analysis|||CD16+CD56+, Week 1||1.354|0.794|0.786
71813841|NCT02799472|143129762|OTHER||Ratio|0.818||||0.188|TWO_SIDED|95.0|0.603|1.109|||Repeated measures analysis|||CD16+CD56+, Week 4||1.109|0.603|0.188
71813842|NCT02799472|143129762|OTHER||Ratio|0.763||||0.129|TWO_SIDED|95.0|0.536|1.087|||Repeated measures analysis|||CD16+CD56+, Week 12||1.087|0.536|0.129
71813843|NCT02799472|143129762|OTHER||Ratio|0.709||||0.054|TWO_SIDED|95.0|0.499|1.006|||Repeated measures analysis|||CD16+CD56+, 12-Week FU||1.006|0.499|0.054
71813844|NCT02799472|143129762|OTHER||Ratio|1.119||||0.383|TWO_SIDED|95.0|0.863|1.45|||Repeated measures analysis|||CD19, Week 1||1.450|0.863|0.383
71813845|NCT02799472|143129762|OTHER||Ratio|0.89||||0.51|TWO_SIDED|95.0|0.623|1.271|||Repeated measures analysis|||CD19, Week 4||1.271|0.623|0.510
71813846|NCT02799472|143129762|OTHER||Ratio|0.952||||0.724|TWO_SIDED|95.0|0.718|1.262|||Repeated measures analysis|||CD19, Week 12||1.262|0.718|0.724
71813847|NCT02799472|143129762|OTHER||Ratio|0.958||||0.831|TWO_SIDED|95.0|0.635|1.443|||Repeated measures analysis|||CD19, 12-Week FU||1.443|0.635|0.831
71813848|NCT02799472|143129762|OTHER||Ratio|1.082||||0.437|TWO_SIDED|95.0|0.882|1.328|||Repeated measures analysis|||CD3, Week 1||1.328|0.882|0.437
71813849|NCT02799472|143129762|OTHER||Ratio|0.937||||0.632|TWO_SIDED|95.0|0.711|1.234|||Repeated measures analysis|||CD3, Week 4||1.234|0.711|0.632
71813850|NCT02799472|143129762|OTHER||Ratio|1.088||||0.413|TWO_SIDED|95.0|0.885|1.336|||Repeated measures analysis|||CD3, Week 12||1.336|0.885|0.413
71813851|NCT02799472|143129762|OTHER||Ratio|1.062||||0.567|TWO_SIDED|95.0|0.858|1.316|||Repeated measures analysis|||CD3, 12-Week FU||1.316|0.858|0.567
71813852|NCT02799472|143129762|OTHER||Ratio|1.069||||0.547|TWO_SIDED|95.0|0.855|1.338|||Repeated measures analysis|||CD3+CD4+, Week 1||1.338|0.855|0.547
71813853|NCT02799472|143129762|OTHER||Ratio|0.907||||0.512|TWO_SIDED|95.0|0.673|1.223|||Repeated measures analysis|||CD3+CD4+, Week 4||1.223|0.673|0.512
71813854|NCT02799472|143129762|OTHER||Ratio|1.064||||0.573|TWO_SIDED|95.0|0.853|1.328|||Repeated measures analysis|||CD3+CD4+, Week 12||1.328|0.853|0.573
71813855|NCT02799472|143129762|OTHER||Ratio|1.031||||0.789|TWO_SIDED|95.0|0.818|1.3|||Repeated measures analysis|||CD3+CD4+, 12-Week FU||1.300|0.818|0.789
71813856|NCT02799472|143129763|OTHER||Mean Difference (Net)|0.036||||0.428|TWO_SIDED|95.0|-0.056|0.128|||Repeated measures analysis|||CD3+CD8+, Week 1||0.128|-0.056|0.428
71813857|NCT02799472|143129763|OTHER||Mean Difference (Net)|-0.023||||0.733|TWO_SIDED|95.0|-0.159|0.113|||Repeated measures analysis|||CD3+CD8+, Week 4||0.113|-0.159|0.733
71813858|NCT02799472|143129763|OTHER||Mean Difference (Net)|0.02||||0.677|TWO_SIDED|95.0|-0.076|0.115|||Repeated measures analysis|||CD3+CD8+, Week 12||0.115|-0.076|0.677
71813859|NCT02799472|143129763|OTHER||Mean Difference (Net)|0.033||||0.569|TWO_SIDED|95.0|-0.084|0.151|||Repeated measures analysis|||CD3+CD8+, 12-Week FU||0.151|-0.084|0.569
71676496|NCT04532619|142870855|SUPERIORITY||Odds Ratio, log|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.24|TWO_SIDED|||||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology. A logistic link function was used for this binary outcome.||||.24
71810395|NCT02052310|143122401|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|4.3|||||TWO_SIDED|95.0|-0.1|8.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||8.7|-0.1|
71810396|NCT02052310|143122402|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% CI for the treatment difference in LS means of change from baseline Hb averaged over Weeks 28 to 52 lay entirely above -0.75 g/dL.|LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.0148|TWO_SIDED|95.0|0.032|0.296|||Mixed Models Analysis|||Treatment comparison was made using mixed model for repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors except mean qualifying screening hemoglobin (≤8.0 vs. \>8.0 g/dL) as fixed effects.||0.296|0.032|0.0148
71810397|NCT02052310|143122403|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|-18.34|STANDARD_ERROR_OF_MEAN|1.584|<|0.0001|TWO_SIDED|95.0|-21.448|-15.232|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline LDL cholesterol as a covariate, and treatment, visit, visit-by-treatment interaction and randomization stratification factors as fixed effects.||-15.232|-21.448|<0.0001
71810398|NCT02052310|143122404|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.099||0.8178|TWO_SIDED|95.0|-0.171|0.217|||ANCOVA|ANCOVA multiple imputation||Treatment comparison was made using the multiple imputation strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, region and cardiovascular/cerebrovascular/thromboembolic medical history (yes vs. no) as factors.||0.217|-0.171|0.8178
71810399|NCT02052310|143122405|SUPERIORITY|||||||0.00028||||||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, and randomization stratification factors as fixed effects.||||0.00028
71810400|NCT02052310|143122406|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|1.26||||0.3284|TWO_SIDED|95.0|0.791|2.016|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening hemoglobin (\<= 8.0 vs. \>8.0 g/dL) as fixed effects.||2.016|0.791|0.3284
71810401|NCT00420199|143122465|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-0.5|||||TWO_SIDED|95.0|-1.77|0.76|||ANCOVA|||Comparison in the change from baseline of erosion score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||0.76|-1.77|
71810402|NCT00420199|143122466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.103||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging score method between abatacept and placebo at Day 113 based on a nonparametric analysis of covariance model. Baseline and changes from baseline of the total wrist synovitis scores were ranked, and the model included the rank score for change from baseline as the dependent variable with treatment group as a main effect and the rank score for baseline as an additional covariate.||||0.103
71813860|NCT02799472|143129763|OTHER||Mean Difference (Net)|0.103||||0.569|TWO_SIDED|95.0|-0.263|0.469|||Repeated measures analysis|||T Cell B Cell NKL, Week 1||0.469|-0.263|0.569
71813861|NCT02799472|143129763|OTHER||Mean Difference (Net)|-0.157||||0.534|TWO_SIDED|95.0|-0.668|0.354|||Repeated measures analysis|||T Cell B Cell NKL, Week 4||0.354|-0.668|0.534
71813862|NCT02799472|143129763|OTHER||Mean Difference (Net)|0.087||||0.668|TWO_SIDED|95.0|-0.323|0.498|||Repeated measures analysis|||T Cell B Cell NKL, Week 12||0.498|-0.323|0.668
71813863|NCT02799472|143129763|OTHER||Mean Difference (Net)|-0.021||||0.934|TWO_SIDED|95.0|-0.526|0.484|||Repeated measures analysis|||T Cell B Cell NKL, 12-Week FU||0.484|-0.526|0.934
71813864|NCT02799472|143129764|OTHER||Ratio|1.112||||0.369|TWO_SIDED|95.0|0.876|1.412|||Repeated measures analysis|||CD3+ CD4+, Week 1||1.412|0.876|0.369
71813865|NCT02799472|143129764|OTHER||Ratio|0.941||||0.641|TWO_SIDED|95.0|0.721|1.228|||Repeated measures analysis|||CD3+ CD4+, Week 4||1.228|0.721|0.641
71813866|NCT02799472|143129764|OTHER||Ratio|1.024||||0.844|TWO_SIDED|95.0|0.804|1.303|||Repeated measures analysis|||CD3+ CD4+, Week 12||1.303|0.804|0.844
71813867|NCT02799472|143129764|OTHER||Ratio|1.082||||0.558|TWO_SIDED|95.0|0.821|1.427|||Repeated measures analysis|||CD3+ CD4+, 12-Week FU||1.427|0.821|0.558
71813868|NCT02799472|143129764|OTHER||Ratio|1.111||||0.363|TWO_SIDED|95.0|0.88|1.402|||Repeated measures analysis|||CD3+ CD8+, Week 1||1.402|0.880|0.363
71813869|NCT02799472|143129764|OTHER||Ratio|0.957||||0.751|TWO_SIDED|95.0|0.724|1.265|||Repeated measures analysis|||CD3+ CD8+, Week 4||1.265|0.724|0.751
71813870|NCT02799472|143129764|OTHER||Ratio|1.076||||0.537|TWO_SIDED|95.0|0.846|1.37|||Repeated measures analysis|||CD3+ CD8+, Week 12||1.370|0.846|0.537
71813871|NCT02799472|143129764|OTHER||Ratio|1.032||||0.806|TWO_SIDED|95.0|0.797|1.335|||Repeated measures analysis|||CD3+ CD8+, 12-Week FU||1.335|0.797|0.806
71810403|NCT00420199|143122468|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-3.48|||||TWO_SIDED|95.0|-6.0|-0.96|||ANCOVA|||Comparison in the change from baseline of Edema/Osteitis score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-0.96|-6.00|
71810404|NCT00420199|143122471|SUPERIORITY_OR_OTHER||Adjusted Mean Difference from Placebo|-4.71|||||TWO_SIDED|95.0|-8.0|-1.42|||ANCOVA|||Comparison in the change from baseline of RAMRIS score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.||-1.42|-8.00|
71810405|NCT00420199|143122485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.078||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging (MRI) score method between ABA and PLA at Day 113 based on a parametric analysis of covariance model (ANCOVA). The model included the score change from baseline as the dependent variable, treatment group as a main effect and baseline score as an additional covariate.||||0.078
71810406|NCT01301391|143122505|SUPERIORITY||Single proportion|0.54|||<|0.001|TWO_SIDED|95.0|0.33|0.74||A priori threshold for statistical significance = 0.05|Fisher Exact|||H0:p≤ 25% vs H1:p\> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If \>=4 successes out of the first 15 patients are observed, accrual will continue up to 30.||0.74|0.33|<0.001
71810407|NCT02629991|143122516|SUPERIORITY|||||||0.059||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.059
71895411|NCT00151411|143313397|SUPERIORITY||rate ratio|1.2||||0.51|TWO_SIDED|95.0|0.7|1.9|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the count of ovulations provided a woman actually ovulated.||1.9|0.7|0.51
71895412|NCT00151411|143313398|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.05|TWO_SIDED|95.0|0.1|9.0|||Mixed Models Analysis|||||9.0|0.1|0.05
71895413|NCT04426630|143313404|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||<0.001
71895414|NCT04426630|143313405|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
71895415|NCT04426630|143313406|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
71810408|NCT02629991|143122517|SUPERIORITY|||||||0.088||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.088
71810409|NCT02629991|143122518|SUPERIORITY|||||||0.027|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.027
71810410|NCT02629991|143122519|SUPERIORITY|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.16|||||||Mixed effects model|||||||0.16
71810411|NCT02629991|143122520|SUPERIORITY|||||||0.69|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.69
71810412|NCT02629991|143122521|SUPERIORITY|||||||0.034||||||Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.|Mixed effects model|||||||0.034
71810413|NCT02629991|143122522|SUPERIORITY|||||||0.009|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.009
71813872|NCT02799472|143129764|OTHER||Ratio|1.101||||0.405|TWO_SIDED|95.0|0.872|1.391|||Repeated measures analysis|||CD3+, Week 1||1.391|0.872|0.405
71813873|NCT02799472|143129764|OTHER||Ratio|0.907||||0.519|TWO_SIDED|95.0|0.668|1.232|||Repeated measures analysis|||CD3+, Week 4||1.232|0.668|0.519
71813874|NCT02799472|143129764|OTHER||Ratio|1.036||||0.748|TWO_SIDED|95.0|0.831|1.291|||Repeated measures analysis|||CD3+, Week 12||1.291|0.831|0.748
71813875|NCT02799472|143129764|OTHER||Ratio|1.049||||0.704|TWO_SIDED|95.0|0.811|1.356|||Repeated measures analysis|||CD3+, 12-Week FU||1.356|0.811|0.704
71813876|NCT02799472|143129765|OTHER||Mean Difference (Net)|6.5||||0.501|TWO_SIDED|95.0|-13.1|26.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 1||26.1|-13.1|0.501
71813877|NCT02799472|143129765|OTHER||Mean Difference (Net)|-1.8||||0.852|TWO_SIDED|95.0|-21.6|18.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 4||18.0|-21.6|0.852
71813878|NCT02799472|143129765|OTHER||Mean Difference (Net)|6.3||||0.572|TWO_SIDED|95.0|-16.4|29.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 12||29.0|-16.4|0.572
71813879|NCT02799472|143129765|OTHER||Mean Difference (Net)|10.5||||0.363|TWO_SIDED|95.0|-13.0|34.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, 12-Week FU||34.1|-13.0|0.363
71813880|NCT02799472|143129765|OTHER||Mean Difference (Net)|2.0||||0.788|TWO_SIDED|95.0|-13.0|17.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 1||17.0|-13.0|0.788
71813881|NCT02799472|143129765|OTHER||Mean Difference (Net)|-2.2||||0.786|TWO_SIDED|95.0|-18.8|14.4|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 4||14.4|-18.8|0.786
71813882|NCT02799472|143129765|OTHER||Mean Difference (Net)|-7.1||||0.433|TWO_SIDED|95.0|-25.4|11.2|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 12||11.2|-25.4|0.433
71813883|NCT02799472|143129765|OTHER||Mean Difference (Net)|4.1||||0.55|TWO_SIDED|95.0|-9.8|18.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, 12-Week FU||18.0|-9.8|0.550
71810414|NCT02629991|143122523|SUPERIORITY|||||||0.033|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.033
71810415|NCT02629991|143122524|SUPERIORITY|||||||0.78|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.78
71810416|NCT02629991|143122525|SUPERIORITY|||||||0.53|||||||Mixed effects model|Mixed effects model with random slopes and intercepts, including main effects for time and treatment group and a time by treatment interaction term.||||||0.53
71810417|NCT02799784|143122526|NON_INFERIORITY|If the lower bound of the two-sided 95% confidence interval around the (UMEC/VI 62.5/25 mcg versus TIO/OLO 5/5 mcg) treatment difference is above -50 milliliter then UMEC/VI 62.5/25 mcg was to be considered non-inferior to TIO/OLO 5/5 mcg.|Mean Difference (Final Values)|0.053|||<|0.001|TWO_SIDED|95.0|0.026|0.08|||Mixed Models Analysis|||||0.080|0.026|<0.001
71810418|NCT01624948|143122527|SUPERIORITY_OR_OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
71810419|NCT01624948|143122529|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Difference in p70S6 kinase phosphorylation as measured by mean fluorescence intensity (MFI) between those patients who reached the primary endpoint and those who did not||||0.67
71810420|NCT01624948|143122530|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71810421|NCT01624948|143122532|SUPERIORITY_OR_OTHER|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
71810422|NCT03387579|143122533|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.590
71810423|NCT03387579|143122533|SUPERIORITY|||||||0.224|||||||Fisher Exact|||||||0.224
71810424|NCT03387579|143122533|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71810425|NCT03387579|143122534|SUPERIORITY|||||||0.471|||||||Kruskal-Wallis|||||||0.471
71810426|NCT03387579|143122535|SUPERIORITY|||||||0.525|||||||Kruskal-Wallis|||||||0.525
71810427|NCT03387579|143122536|SUPERIORITY|||||||0.753|||||||Kruskal-Wallis|||||||0.753
71810428|NCT03387579|143122537|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||||||0.008
71810429|NCT03387579|143122538|SUPERIORITY|||||||0.127|||||||Fisher Exact|||||||0.127
71810430|NCT03387579|143122539|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71810431|NCT03387579|143122540|SUPERIORITY||estimate|8.553||||0.046|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 4.249|||||0.046
71844043|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.1|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||1.3|-2.1|
71844044|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.9|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||1.6|-1.9|
71844045|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||1.7|-1.9|
71810432|NCT03387579|143122540|SUPERIORITY||estimate|7.023||||0.04|TWO_SIDED|||||Intralipid 20% historic versus smoflipid|Mixed Models Analysis||standard error 3.376|||||0.040
71810433|NCT03387579|143122540|SUPERIORITY||estimate|-1.53||||0.718|TWO_SIDED|||||Intralipid 20% Historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.231|||||0.718
71810434|NCT03387579|143122541|SUPERIORITY||estimate|13.436||||0.003|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 4.440|||||0.003
71810435|NCT03387579|143122541|SUPERIORITY||estimate|3.936||||0.27|TWO_SIDED|||||Intralipid 20% historic versus Smoflipid 20%|Mixed Models Analysis||standard error 3.553|||||0.270
71810436|NCT03387579|143122541|SUPERIORITY||estimate|-9.5||||0.034|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 4.416|||||0.034
71810437|NCT03387579|143122542|SUPERIORITY||estimate|42.674||||0.006|TWO_SIDED|||||Intralipid 20% reduction versus Smoflipid 20%|Mixed Models Analysis||standard error 15.216|||||0.006
71810438|NCT03387579|143122542|SUPERIORITY||estimate|11.117||||0.305|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.771|||||0.305
71810439|NCT03387579|143122542|SUPERIORITY||estimate|-31.557|||<|0.001|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 67.673|||||<0.001
71810440|NCT03387579|143122543|SUPERIORITY||estimate|-0.593||||0.835|TWO_SIDED|||||Intralipid 20% reduction versus smoflipid 20%|Mixed Models Analysis||standard error 2.848|||||0.835
71810441|NCT03387579|143122543|SUPERIORITY||estimate|-0.522||||0.799|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 2.050|||||0.799
71810442|NCT03387579|143122543|SUPERIORITY||estimate|0.714||||0.714|TWO_SIDED|||||Intralipid 20% historic versus Intralipid 20% reduction|Mixed Models Analysis||standard error 2.758|||||0.714
71810443|NCT03387579|143122544|SUPERIORITY||estimate|11.162||||0.379|TWO_SIDED||||||Mixed Models Analysis|Intralipid 20% reduction versus smoflipid 20%|standard error 12.626|||||0.379
71810444|NCT03387579|143122544|SUPERIORITY||estimate|3.853||||0.717|TWO_SIDED|||||Intralipid 20% historic versus smoflipid 20%|Mixed Models Analysis||standard error 10.615|||||0.717
71810445|NCT03387579|143122544|SUPERIORITY|Intralipid 20% historic versus intralipid 20% reduction|estimate|-7.31||||0.576|TWO_SIDED||||||Mixed Models Analysis||standard error 13.025|||||0.576
71810446|NCT03387579|143122545|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
71810447|NCT03387579|143122545|SUPERIORITY|||||||1|||||||Fisher Exact|||ROP||||1.00
71810448|NCT03387579|143122546|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71810449|NCT03387579|143122546|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.640
71810450|NCT03387579|143122546|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71810451|NCT03387579|143122547|SUPERIORITY|||||||0.211|||||||Kruskal-Wallis|||||||0.211
71810452|NCT03387579|143122548|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.720
71810453|NCT03387579|143122549|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.500
71810454|NCT03387579|143122550|SUPERIORITY|||||||0.774|||||||t-test, 2 sided|||||||0.774
71810455|NCT03387579|143122551|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
71810456|NCT03387579|143122552|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||||||0.475
71810457|NCT03466086|143122553|SUPERIORITY|This was a pilot study and the sample size was not based on any empirical power calculation.|Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.238|||TWO_SIDED|95.0|-2.35|2.59||Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is greater than 0.|Multivariate Bayesian Model|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.|Mean Difference was calculated as Test minus Control.|||2.59|-2.35|
71810458|NCT03466086|143122554|SUPERIORITY|Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.|Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|0.951|||TWO_SIDED|95.0|-0.4|3.37|||Multivariate Bayesian Analysis|The correlation between measurements across periods were modeled using unstructured variance-covariance matrix.||This was a pilot study and the sample size was not based on any empirical power calculation.|Mean difference was calculated as Test - Control|3.37|-0.40|
71810459|NCT02570126|143122568|NON_INFERIORITY|Criterion for the Varilrix HSA-free vaccine as compared to Varilrix™ vaccine, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR\_HSA\_F minus VAR) in incidence of fever \> 39.0°C (\> 102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%|Difference in percentage between groups|-1.29|||||TWO_SIDED|95.0|-3.72|1.08|||||Power obtained using PASS 2005 (Likelihood Score \[Miettinen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=2.5%|Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever \> 39.0°C (\> 102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR\_HSA\_F Group minus VAR Group)||1.08|-3.72|
71810460|NCT00917579|143122578|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|95.34||||||90.0|91.33|99.52|||ANOVA|Values were back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||99.52|91.33|
71810461|NCT00917579|143122579|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both the AUCinf and Cmax fell within (80%, 125%). AUCinf method of determination includes AUC last calculated value.|ratio of adjusted geometric means|95.79||||||90.0|91.07|100.76|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.76|91.07|
71813884|NCT02799472|143129766|OTHER||Mean Difference (Net)|14.6||||0.35|TWO_SIDED|95.0|-16.9|46.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1||46.1|-16.9|0.350
71813885|NCT02799472|143129766|OTHER||Mean Difference (Net)|8.4||||0.697|TWO_SIDED|95.0|-35.3|52.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4||52.0|-35.3|0.697
71813886|NCT02799472|143129766|OTHER||Mean Difference (Net)|-49.2||||0.249|TWO_SIDED|95.0|-135.2|36.8|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12||36.8|-135.2|0.249
71895416|NCT04426630|143313407|SUPERIORITY|||||||0.028|||||||Chi-squared|Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.||Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.||||0.028
71895417|NCT04426630|143313408|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71810462|NCT00917579|143122580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|91.41||||||90.0|83.39|100.2|||ANOVA|Values have been back-transformed from the log scale.|Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.||100.20|83.39|
71810463|NCT04020341|143122606|NON_INFERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for non-inferiority is if the Z-statistic for non-inferiority is greater than the Z-statistic boundary (2.065).|Adjusted Difference in Percent|4.3|||||TWO_SIDED|95.0|-3.6|12.1|||||||Observed Z statistic value for Noninferiority was 3.5554.|12.1|-3.6|
71810464|NCT04020341|143122606|SUPERIORITY|The difference in success rate between treatment groups (gepotidacin - nitrofurantoin) was calculated using Miettinen-Nurminen Summary Score Method adjusted for age group and acute cystitis recurrence strata combinations. Criteria for superiority is if the one-sided p-value is less than the 0.019 p-value boundary.|Adjusted difference of Percent|4.3||||0.1445|TWO_SIDED|95.0|-3.6|12.1|||1-sided p-value for Test of Superiority|||||12.1|-3.6|0.1445
71810465|NCT00677352|143122641|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.|Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.5|1.6|||ANCOVA|||The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group - paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.||1.6|-2.5|
71810466|NCT00677352|143122647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062|TWO_SIDED|||||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).|Fisher Exact|||||||0.0062
71810467|NCT04683926|143122649|OTHER||AUC(0-36) Estimate (β1)|1.0227|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
71810468|NCT04683926|143122649|OTHER||AUC(inf) Estimate (β1)|1.0223|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
71810469|NCT04683926|143122649|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|AUC(0-inf) fed/fasted ratio|1.09|||||TWO_SIDED|90.0|1.05|1.12||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.12|1.05|
71810470|NCT04683926|143122650|OTHER||Cmax Estimate (β1)|0.9899|||||TWO_SIDED|||||||||Analysis of dose proportionality following 10, 20 and 30 mg fasted using a mixed-effects model based on a power function: ln(dependent variable) = β1×ln(Dose) + ln(β0) + ε. Random slope and intercept. 90% CI of β1 acceptance range of 0.8-1.25 modified to account for ratio of dose levels in this study as follows: \[1+ln(0.8)/ln(3), 1+ln(1.25)/ln(3)\], giving acceptance range of \[0.7969, 1.2031\]. If the 90% CI of β1 is within \[0.7969, 1.2031\], dose-proportionality is proven for the PK parameter.||||
71810471|NCT04683926|143122650|EQUIVALENCE|Absent food effect will be established if the 90% CI for the ratio of population geometric means between fed and fasted 30 mg doses, based on log-transformed data, is contained in the equivalence limits of 0.80-1.25 for AUC0-inf and Cmax.|Cmax 90% fed/fasted ratio|1.18|||||TWO_SIDED|90.0|1.08|1.28||||||Analysis of food effect on desmetramadol in the evaluable population using natural logarithm-transformed PK exposure parameters of desmetramadol enantiomers following administration of 30 mg desmetramadol in the fed and fasted states.||1.28|1.08|
71810472|NCT02740049|143122676|SUPERIORITY|||||||0.0002||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0002
71810473|NCT02740049|143122677|SUPERIORITY|||||||0.3994||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or Wilcoxon signed rank test as appropriate.||||0.3994
71895418|NCT04426630|143313409|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71895419|NCT04426630|143313410|SUPERIORITY|||||||0.23|||||||Chi-squared|||||||0.23
71895420|NCT04426630|143313411|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71676497|NCT04532619|142870856|SUPERIORITY||Slope|-1.33||||0.43|TWO_SIDED|95.0|-4.64|1.98||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||1.98|-4.64|0.43
71676498|NCT04532619|142870857|SUPERIORITY||Slope|-2.06||||0.07|TWO_SIDED|95.0|-4.27|0.15||computed p-value|Mixed Models Analysis|||We used a multilevel models to produce regression estimates. We used multiple imputation. Intervention enrollment was coded as 1 and enrollment in the control arm was coded as 0. We accounted for baseline values and psychopathology.||0.15|-4.27|0.07
71676499|NCT01435018|142870860|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically relevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-30.3|||||TWO_SIDED|95.0|-52.3|-8.3|||||Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-8.3|-52.3|
71810474|NCT02740049|143122678|SUPERIORITY|||||||0.0104||||||P value is the comparison between the IFN/TNF induction group versus VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical difference is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.||||0.0104
71810475|NCT00716092|143122689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001||95.0|-28.0|-11.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-11.9|-28.0|<0.0001
71810476|NCT00716092|143122690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.1|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001||95.0|12.4|23.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||23.9|12.4|<0.0001
71810477|NCT00716092|143122691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.8||0.0283||95.0|-20.4|-1.2|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-1.2|-20.4|0.0283
71810478|NCT00716092|143122692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.5|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001||95.0|-147.0|-66.0|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo||-66.0|-147.0|<0.0001
71810479|NCT00716092|143122693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|3.9||0.1274||95.0|-1.7|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-1.7|0.1274
71810480|NCT00716092|143122694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|2.7||0.313||95.0|-2.7|8.2|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||8.2|-2.7|0.3130
71810481|NCT00716092|143122695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|4.3||0.2281||95.0|-3.3|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||13.8|-3.3|0.2281
71810482|NCT00716092|143122696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|STANDARD_ERROR_OF_MEAN|18.6||0.223||95.0|-14.0|59.5|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.||59.5|-14.0|0.2230
71810483|NCT00677235|143122708|SUPERIORITY_OR_OTHER|||||||0.449|||||||Fisher Exact|||||||0.449
71810484|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.641|||<|0.001|TWO_SIDED|95.0|1.247|2.159|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=12.514||Age of mother bearing, \<=30 years vs \>30 years||2.159|1.247|<0.001
71810485|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.793||||0.06|TWO_SIDED|95.0|0.622|1.01|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.529||Household register, local vs nonlocal||1.010|0.622|0.060
71810486|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.369||||0.006|TWO_SIDED|95.0|1.672|32.479|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.524||Mother's education level, illiteracy vs postgraduate or above||32.479|1.672|0.006
71810487|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.443||||0.102|TWO_SIDED|95.0|1.001|11.843|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.671||Mother's education level, elementary school vs postgraduate or above||11.843|1.001|0.102
71813887|NCT02799472|143129766|OTHER||Mean Difference (Net)|-30.1||||0.119|TWO_SIDED|95.0|-68.6|8.3|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, 12-Week FU||8.3|-68.6|0.119
71813888|NCT02799472|143129766|OTHER||Mean Difference (Net)|6.5||||0.403|TWO_SIDED|95.0|-9.3|22.4|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1||22.4|-9.3|0.403
71810488|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.064||||0.159|TWO_SIDED|95.0|0.933|10.067|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.984||Mother's education level, junior middle school vs postgraduate or above||10.067|0.933|0.159
71810489|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.321||||0.662|TWO_SIDED|95.0|0.71|7.589|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.191||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||7.589|0.710|0.662
71844046|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||2.2|-1.4|
71844047|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.4|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||1.3|-2.4|
71844048|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-1.2|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||2.5|-1.2|
71844049|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|95.0|-2.9|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.8|-2.9|
71844050|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.1|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||1.6|-2.1|
71844051|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.2|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||1.6|-2.2|
71810490|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.306|||<|0.001|TWO_SIDED|95.0|0.399|4.277|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=13.525||Mother's education level, college/university vs postgraduate or above||4.277|0.399|<0.001
71810491|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.217||||0.043|TWO_SIDED|95.0|0.719|6.831|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.095||Family monthly income per capita, \<=600 RMB vs \>=10000 RMB||6.831|0.719|0.043
71810492|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.089||||0.01|TWO_SIDED|95.0|0.739|5.906|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=6.549||Family monthly income per capita, 600 to 1999 RMB vs \>=10000 RMB||5.906|0.739|0.010
71810493|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.983||||0.021|TWO_SIDED|95.0|0.704|5.583|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.313||Family monthly income per capita, 2000 to 4999 RMB vs \>=10000 RMB||5.583|0.704|0.021
71844052|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.9|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||2.1|-1.9|
71844053|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||1.9|-2.1|
71844054|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-1.8|2.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||2.2|-1.8|
71844055|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.3|-2.5|
71895421|NCT04426630|143313412|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
71895422|NCT04426630|143313413|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||<0.001
71895423|NCT04426630|143313414|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||||||0.07
71895424|NCT04426630|143313415|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71895425|NCT01819935|143313416|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2||||||Propensity Cox proportional hazards regression model was used.||1.20|0.72|
71895426|NCT01819935|143313417|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.53|1.05||||||Propensity Cox proportional hazards regression model was used.||1.05|0.53|
71895427|NCT01819935|143313418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15||||||Propensity Cox proportional hazards regression model was used.||1.15|0.90|
71895428|NCT01819935|143313419|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.39|1.09||||||Propensity Cox proportional hazards regression model was used.||1.09|0.39|
71895429|NCT01819935|143313420|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.68|1.37||||||Propensity Cox proportional hazards regression model was used.||1.37|0.68|
71895430|NCT01819935|143313421|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.68|1.13||||||Propensity Cox proportional hazards regression model was used.||1.13|0.68|
71895431|NCT01819935|143313422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.48||||||Propensity Cox proportional hazards regression model was used.||1.48|0.54|
71895432|NCT01819935|143313423|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|1.06|1.45||||||Propensity Cox proportional hazards regression model was used.||1.45|1.06|
71810494|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.364|TWO_SIDED|95.0|0.344|3.267|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.824||Family monthly income per capita, 5000 to 7999 RMB vs \>=10000 RMB||3.267|0.344|0.364
71810495|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58||||0.175|TWO_SIDED|95.0|0.1|3.347|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.838||||3.347|0.100|0.175
71810496|NCT00952367|143122725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.516|||<|0.001|TWO_SIDED|95.0|0.4|0.666|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=25.960||Whether have brothers or sisters, no vs yes||0.666|0.400|<0.001
71810497|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.255||||0.057|TWO_SIDED|95.0|0.062|1.044|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.610||Birth information, preterm birth vs full-term birth||1.044|0.062|0.057
71810498|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.04|TWO_SIDED|95.0|0.451|0.981|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.228||Household register, local vs nonlocal||0.981|0.451|0.040
71810499|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.044|TWO_SIDED|95.0|0.758|1.844|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.074||Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding||1.844|0.758|0.044
71810500|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.707||||0.038|TWO_SIDED|95.0|0.42|1.191|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.316||Feeding manners within 6 months, mixed feeding vs pure formula milk feeding||1.191|0.420|0.038
71810501|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|92.229||||0.006|TWO_SIDED|95.0|3.993|2130.5|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.438||Father's education level, illiteracy vs postgraduate or above||2130.500|3.993|0.006
71810502|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.671||||0.778|TWO_SIDED|95.0|0.537|40.608|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.079||Father's education level, elementary school vs postgraduate or above||40.608|0.537|0.778
71810503|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.83||||0.756|TWO_SIDED|95.0|0.649|35.956|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.096||Father's education level, junior high school vs postgraduate or above||35.956|0.649|0.756
71810504|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.513||||0.179|TWO_SIDED|95.0|0.474|26.03|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.807||Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||26.030|0.474|0.179
71810505|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.029||||0.077|TWO_SIDED|95.0|0.412|22.292|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.131||Father's education level, college/university vs postgraduate or above||22.292|0.412|0.077
71810506|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984||||0.056|TWO_SIDED|95.0|0.968|1.0|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.648||Living space per capita, continuous variables||1.000|0.968|0.056
71810507|NCT00952367|143122726|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.064|TWO_SIDED|95.0|0.522|1.018|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.432||Vaccination history of Hib, no vs yes||1.018|0.522|0.064
71810508|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.438||||0.019|TWO_SIDED|95.0|0.221|0.871|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.538||Birth information, preterm birth vs full-term birth||0.871|0.221|0.019
71810509|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.546|||<|0.001|TWO_SIDED|95.0|0.423|0.703|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=21.938||Household register, local vs nonlocal||0.703|0.423|<0.001
71810510|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.137||||0.559|TWO_SIDED|95.0|0.473|9.652|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.341||Mother's education level, illiteracy vs graduate or above||9.652|0.473|0.559
71844056|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.8|-2.1|
71844057|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.2|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||1.8|-2.2|
71844058|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.9|-2.2|
71844059|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.5|1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||1.5|-2.5|
71810511|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.793||||0.626|TWO_SIDED|95.0|0.596|5.394|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.238||Mother's education level, elementary school vs graduate or above||5.394|0.596|0.626
71810512|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.972||||0.193|TWO_SIDED|95.0|0.699|5.562|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.691||Mother's education level, junior middle school vs graduate or above||5.562|0.699|0.193
71810513|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.298|TWO_SIDED|95.0|0.679|5.353|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.081||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above||5.353|0.679|0.298
71810514|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.233||||0.122|TWO_SIDED|95.0|0.439|3.464|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.395||Mother's education level, college/university vs postgraduate or above||3.464|0.439|0.122
71676500|NCT01435018|142870861|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-19.8|||||TWO_SIDED|95.0|-32.3|-7.4|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.||-7.4|-32.3|
71676501|NCT01435018|142870861|NON_INFERIORITY|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15 percent of PTX+ART. The selection of the 15 percent non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-20.1|||||TWO_SIDED|95.0|-32.2|-7.9|||||Confidence interval estimation was stratified by country using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative PFS rate with 95% two-sided confidence interval.||-7.9|-32.2|
71676502|NCT01435018|142870862|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
71810515|NCT00952367|143122727|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.666||||0.001|TWO_SIDED|95.0|0.52|0.855|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=10.233||Whether have brothers or sisters, no vs yes||0.855|0.520|0.001
71810516|NCT04570436|143122734|SUPERIORITY||Mean Difference (Final Values)|30.9|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|26.2||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of diazepam, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 = 15"|||26.2|<0.0001
71810517|NCT04570436|143122734|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.84||0.3581|ONE_SIDED|95.0||14.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.7||0.3581
71810518|NCT04570436|143122734|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|9.5|STANDARD_ERROR_OF_MEAN|2.85||0.3051|ONE_SIDED|95.0||14.3|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||14.3||0.3051
71810519|NCT04570436|143122734|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|2.83||0.2179|ONE_SIDED|95.0||13.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin (T) produced mean responses that show abuse potential similar to placebo.~H0: μT - μP ≥ δ3 versus Ha: μT - μP \< δ3 where δ3 =11"||13.5||0.2179
71810520|NCT04570436|143122734|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.3||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.3|<0.0001
71810521|NCT04570436|143122734|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|21.4|STANDARD_ERROR_OF_MEAN|2.84|<|0.0001|ONE_SIDED|95.0|16.7||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||16.7|<0.0001
71810522|NCT04570436|143122734|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|22.1|STANDARD_ERROR_OF_MEAN|2.85|<|0.0001|ONE_SIDED|95.0|17.4||||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (T) produced mean responses that show less abuse potential than diazepam (C) were:~H0: μC - μT ≤ δ2 versus Ha: μC - μT \> δ2 where δ2 =0"|||17.4|<0.0001
71810523|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|325.8|STANDARD_ERROR_OF_MEAN|113.38||0.0023|ONE_SIDED|90.0|138.2||||Mixed Models Analysis||||||138.2|0.0023
71810524|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|140.5|STANDARD_ERROR_OF_MEAN|113.01||0.2157|TWO_SIDED|90.0|-82.7|363.7|||Mixed Models Analysis|||||363.7|-82.7|0.2157
71810525|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|155.4|STANDARD_ERROR_OF_MEAN|113.25||0.172|TWO_SIDED|90.0|-68.3|379.1|||Mixed Models Analysis|||||379.1|-68.3|0.1720
71810526|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|212.2|STANDARD_ERROR_OF_MEAN|113.01||0.0622|TWO_SIDED|90.0|-11.0|435.5|||Mixed Models Analysis|||||435.5|-11.0|0.0622
71810527|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|-185.0|STANDARD_ERROR_OF_MEAN|113.04||0.1031|TWO_SIDED|90.0|-409.0|37.94|||Mixed Models Analysis|||||37.94|-409|0.1031
71810528|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|-170.0|STANDARD_ERROR_OF_MEAN|112.97||0.1334|TWO_SIDED|90.0|-394.0|52.71|||Mixed Models Analysis|||||52.71|-394|0.1334
71844060|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.7|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.4|-2.7|
71844061|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-2.1|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||1.9|-2.1|
71810529|NCT04570436|143122736|OTHER||Mean Difference (Final Values)|-114.0|STANDARD_ERROR_OF_MEAN|113.59||0.3189|TWO_SIDED|90.0|-338.0|110.8|||Mixed Models Analysis|||||110.8|-338|0.3189
71895433|NCT01157169|143313424|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.49|||||TWO_SIDED|90.0|101.67|120.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||120.07|101.67|
71676503|NCT01435018|142870863|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
71676504|NCT01435018|142870865|OTHER||Cumulative rate difference|16.3|||||TWO_SIDED|95.0|3.7|28.8||||||Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of IERC-confirmed KS progression with 95% two-sided confidence interval.|Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|28.8|3.7|
71676505|NCT01435018|142870866|OTHER||Cumulative rate difference|-15.0|||||TWO_SIDED|95.0|-34.4|4.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||4.3|-34.4|
71676506|NCT01435018|142870867|OTHER||Cumulative rate difference|-3.3|||||TWO_SIDED|95.0|-13.3|6.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.||6.6|-13.3|
71676507|NCT01435018|142870868|OTHER||Cumulative rate difference|4.3|||||TWO_SIDED|95.0|-1.9|10.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||10.6|-1.9|
71810530|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|55.77|STANDARD_ERROR_OF_MEAN|5.362|<|0.0001|ONE_SIDED|90.0|46.89||||Mixed Models Analysis||||||46.89|<0.0001
71810531|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|17.18|STANDARD_ERROR_OF_MEAN|5.348||0.0016|TWO_SIDED|90.0|6.61|27.74|||Mixed Models Analysis|||||27.74|6.61|0.0016
71810532|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|21.38|STANDARD_ERROR_OF_MEAN|5.36||0.0001|TWO_SIDED|90.0|10.79|31.96|||Mixed Models Analysis|||||31.96|10.79|0.0001
71810533|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|22.5|STANDARD_ERROR_OF_MEAN|5.352|<|0.0001|TWO_SIDED|90.0|11.92|33.07|||Mixed Models Analysis|||||33.07|11.92|<0.0001
71810534|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|-38.6|STANDARD_ERROR_OF_MEAN|5.312|<|0.0001|TWO_SIDED|90.0|-49.1|-28.1|||Mixed Models Analysis|||||-28.1|-49.1|<0.0001
71810535|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|-34.4|STANDARD_ERROR_OF_MEAN|5.308|<|0.0001|TWO_SIDED|90.0|-44.9|-23.9|||Mixed Models Analysis|||||-23.9|-44.9|<0.0001
71810536|NCT04570436|143122737|OTHER||Mean Difference (Final Values)|-33.3|STANDARD_ERROR_OF_MEAN|5.337|<|0.0001|TWO_SIDED|90.0|-43.8|-22.7|||Mixed Models Analysis|||||-22.7|-43.8|<0.0001
71810537|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|234.9|STANDARD_ERROR_OF_MEAN|38.174|<|0.0001|ONE_SIDED|90.0|171.7||||Mixed Models Analysis||||||171.7|<0.0001
71810538|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|66.3|STANDARD_ERROR_OF_MEAN|38.048||0.0834|TWO_SIDED|90.0|-8.86|141.5|||Mixed Models Analysis|||||141.5|-8.86|0.0834
71676508|NCT01435018|142870869|OTHER||Cumulative rate difference|5.5|||||TWO_SIDED|95.0|-0.1|11.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.||11.0|-0.1|
71810539|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|99.06|STANDARD_ERROR_OF_MEAN|38.128||0.0103|TWO_SIDED|90.0|23.75|174.4|||Mixed Models Analysis|||||174.4|23.75|0.0103
71810540|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|97.2|STANDARD_ERROR_OF_MEAN|38.048||0.0116|TWO_SIDED|90.0|22.05|172.4|||Mixed Models Analysis|||||172.4|22.05|0.0116
71810541|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|-169.0|STANDARD_ERROR_OF_MEAN|38.06|<|0.0001|TWO_SIDED|90.0|-244.0|-93.4|||Mixed Models Analysis|||||-93.4|-244|<0.0001
71810542|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|-136.0|STANDARD_ERROR_OF_MEAN|38.036||0.0005|TWO_SIDED|90.0|-211.0|-60.7|||Mixed Models Analysis|||||-60.7|-211|0.0005
71810543|NCT04570436|143122739|OTHER||Mean Difference (Final Values)|-138.0|STANDARD_ERROR_OF_MEAN|38.243||0.0004|TWO_SIDED|90.0|-213.0|-62.2|||Mixed Models Analysis|||||-62.2|-213|0.0004
71810544|NCT00781391|143122752|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.632|0.985||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||.985|.632|<.0001
71810545|NCT00781391|143122752|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|1.07||||0.0055|TWO_SIDED|97.5|0.874|1.314||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.||1.314|.874|.0055
71810546|NCT00781391|143122753|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.719|1.029|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.029|.719|<.0001
71810547|NCT00781391|143122753|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|1.13||||0.0074|TWO_SIDED|97.5|0.955|1.336|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.336|.955|.0074
71810548|NCT00781391|143122754|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively|Hazard Ratio (HR)|0.79|||<|0.0001|TWO_SIDED|97.5|0.634|0.989|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||.989|.634|<.0001
71810549|NCT00781391|143122754|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|Hazard Ratio (HR)|1.08||||0.0064|TWO_SIDED|97.5|0.878|1.32|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.||1.32|.878|.0064
71810550|NCT00781391|143122755|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|97.5|0.72|1.032|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.032|.720|<.0001
71810551|NCT00781391|143122755|NON_INFERIORITY_OR_EQUIVALENCE|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|1.13||||0.0084|TWO_SIDED|97.5|0.958|1.34|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.||1.34|.958|.0084
71810552|NCT00781391|143122756|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.081|TWO_SIDED|99.0|0.709|1.068|||Log Rank|||The superiority analysis included the ITT analysis set||1.068|.709|.081
71810553|NCT00781391|143122757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0053|TWO_SIDED|95.0|0.786|0.959|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.959|.786|.0053
71810554|NCT00781391|143122758|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0109|TWO_SIDED|95.0|0.806|0.972|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.972|.806|.0109
71810555|NCT00781391|143122759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0168|TWO_SIDED|95.0|0.823|0.981|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.||.981|.823|.0168
71810556|NCT00781391|143122760|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0009|TWO_SIDED|95.0|0.707|0.914|||Regression, Cox|||All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period||.914|.707|.0009
71813889|NCT02799472|143129766|OTHER||Mean Difference (Net)|-2.1||||0.91|TWO_SIDED|95.0|-39.4|35.2|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4||35.2|-39.4|0.910
71813890|NCT02799472|143129766|OTHER||Mean Difference (Net)|-6.5||||0.718|TWO_SIDED|95.0|-43.1|30.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12||30.1|-43.1|0.718
71813891|NCT02799472|143129766|OTHER||Mean Difference (Net)|-5.7||||0.687|TWO_SIDED|95.0|-34.4|23.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU||23.0|-34.4|0.687
71813892|NCT02799472|143129766|OTHER||Mean Difference (Net)|-56.0||||0.559|TWO_SIDED|95.0|-249.8|137.7|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 1||137.7|-249.8|0.559
71813893|NCT02799472|143129766|OTHER||Mean Difference (Net)|51.6||||0.47|TWO_SIDED|95.0|-93.9|197.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 4||197.0|-93.9|0.470
71844062|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.9|-2.2|
71844063|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.3|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||1.7|-2.3|
71844064|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.9|-2.2|
71844065|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.1|2.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||2.0|-2.1|
71676509|NCT01435018|142870872|OTHER||Cumulative rate difference|19.4|||||TWO_SIDED|95.0|-4.1|43.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||43.0|-4.1|
71676510|NCT01435018|142870873|OTHER||Cumulative rate difference|14.4|||||TWO_SIDED|95.0|1.8|27.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.||27.0|1.8|
71676511|NCT01435018|142870874|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||47.4|0.9|
71676512|NCT01435018|142870875|OTHER||Cumulative rate difference|18.8|||||TWO_SIDED|95.0|6.3|31.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.||31.3|6.3|
71676513|NCT01435018|142870876|OTHER||Cumulative rate difference|24.2|||||TWO_SIDED|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||47.4|0.9|
71810557|NCT00781391|143122760|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.47|||<|0.0001|TWO_SIDED|95.0|0.406|0.548|||Regression, Cox|||"All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period.~The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor"||.548|.406|<.0001
71844066|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|95.0|-2.2|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.9|-2.2|
71844067|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-2.0|2.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||2.3|-2.0|
71844068|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-2.4|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.8|-2.4|
71810558|NCT00781391|143122760|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.0001|TWO_SIDED|95.0|0.8|0.918|||Regression, Cox|||Major or Clinically Relevant Non-Major, high dose vs. warfarin||.918|.800|<.0001
71810559|NCT00781391|143122760|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.575|0.666|||Regression, Cox|||Major or Clinically Relevant Non-Major, low dose vs. warfarin||.666|.575|<.0001
71844069|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||2.4|-1.8|
71844070|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-2.1|2.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||2.1|-2.1|
71844071|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||2.7|-1.5|
71676514|NCT01435018|142870877|OTHER||Cumulative rate difference|17.7|||||TWO_SIDED|95.0|6.2|29.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.||29.3|6.2|
71676515|NCT01435018|142870878|OTHER||Cumulative rate difference|37.5|||||TWO_SIDED|95.0|13.6|61.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||61.4|13.6|
71676516|NCT01435018|142870879|OTHER||Cumulative rate difference|11.1|||||TWO_SIDED|95.0|-0.4|22.7|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.||22.7|-0.4|
71676517|NCT01435018|142870880|OTHER||Cumulative rate difference|14.7|||||TWO_SIDED|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||31.4|-1.9|
71676518|NCT01435018|142870881|OTHER||Cumulative rate difference|8.4|||||TWO_SIDED|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.||17.2|-0.4|
71676519|NCT01435018|142870882|OTHER||Hazard Ratio (HR)|1.9|||||TWO_SIDED|95.0|1.1|3.4|||||Hazard ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||3.4|1.1|
71676520|NCT01435018|142870883|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|1.1|2.2|||||Hazard ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||2.2|1.1|
71676521|NCT01435018|142870884|OTHER||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.1|0.7|||||Odds ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.|||0.7|0.1|
71676522|NCT01435018|142870885|OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Odds ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count and country.|||1.3|0.5|
71810560|NCT00420992|143122784|SUPERIORITY_OR_OTHER|||||||0.0445||95.0||||Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.|ANCOVA|Model included treatment as factor and baseline pain score as covariate.||Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.||||0.0445
71810561|NCT03882879|143122806|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.64
71676523|NCT00769067|142870911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.657||||0.012|TWO_SIDED|95.0|0.472|0.914||2-Sided.|Log Rank|Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|"Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.~HR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors"||0.914|0.472|0.012
71676524|NCT00769067|142870912|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||2-Sided.|Chi-squared|Unadjusted.||||||0.011
71810562|NCT03882879|143122807|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71810563|NCT03882879|143122808|SUPERIORITY|||||||0.76||||||Between-group two-sided t-test|t-test, 2 sided|||||||0.76
71810564|NCT03882879|143122809|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71810565|NCT03882879|143122810|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.20
71810566|NCT03923959|143122811|SUPERIORITY||Odds Ratio (OR)|1.013|STANDARD_ERROR_OF_MEAN|0.307||0.966|TWO_SIDED|95.0|0.5597|1.834|||Regression, Logistic||||A two-sample proportion test was also completed; the test utilized an α \< 0.049 to account for the O'Brien-Fleming adjustment. The p-value for the two-sample proportion test was 0.966.|1.834|0.5597|0.966
71810567|NCT03923959|143122812|SUPERIORITY|||||||0.183||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.183
71810568|NCT03923959|143122813|SUPERIORITY|||||||0.729||||||a priori threshold for statistical significance was the standard α = 0.05.|Chi-squared|||||||0.729
71810569|NCT03923959|143122814|SUPERIORITY|||||||0.655||||||a priori threshold for statistical significance was the standard α = 0.05|Chi-squared|||||||0.655
71810570|NCT03923959|143122815|SUPERIORITY|||||||0.7832||||||a priori threshold for statistical significance was the standard α = 0.05.|t-test, 2 sided|||||||0.7832
71813894|NCT02799472|143129766|OTHER||Mean Difference (Net)|-141.5||||0.675|TWO_SIDED|95.0|-829.2|546.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 12||546.3|-829.2|0.675
71813895|NCT02799472|143129766|OTHER||Mean Difference (Net)|-137.9||||0.08|TWO_SIDED|95.0|-294.0|18.2|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, 12-Week FU||18.2|-294.0|0.080
71813896|NCT02799472|143129766|OTHER||Mean Difference (Net)|0.4||||0.989|TWO_SIDED|95.0|-60.5|61.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 1||61.3|-60.5|0.989
71813897|NCT02799472|143129766|OTHER||Mean Difference (Net)|-17.4||||0.634|TWO_SIDED|95.0|-94.3|59.6|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 4||59.6|-94.3|0.634
71813898|NCT02799472|143129766|OTHER||Mean Difference (Net)|59.4||||0.789|TWO_SIDED|95.0|-395.2|513.9|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 12||513.9|-395.2|0.789
71813899|NCT02799472|143129766|OTHER||Mean Difference (Net)|-47.2||||0.249|TWO_SIDED|95.0|-135.5|41.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, 12-Week FU||41.0|-135.5|0.249
71813900|NCT02799472|143129766|OTHER||Mean Difference (Net)|3682.3||||0.234|TWO_SIDED|95.0|-2511.9|9876.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 1||9876.5|-2511.9|0.234
71810571|NCT02954354|143122843|SUPERIORITY||Difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-35.8|-17.8||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||The primary analysis of time to alleviation of symptoms was a comparison of baloxavir with placebo in all participants in the intention-to-treat infection population. Statistical tests were performed at the 0.05 significance level.||-17.8|-35.8|<0.0001
71810572|NCT02954354|143122843|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||<0.0001
71810573|NCT02954354|143122844|SUPERIORITY||Difference|-0.3||||0.756|TWO_SIDED|95.0|-6.6|6.6||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||A secondary analysis of time to alleviation of symptoms, consisting of a comparison between the 20 to 64 years of age stratum of the baloxavir group and the oseltamivir group, was conducted if statistical significance was observed in the primary analysis in order to maintain the overall Type I error.||6.6|-6.6|0.7560
71810574|NCT02954354|143122844|SUPERIORITY|||||||0.3761||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.||||0.3761
71810575|NCT02954354|143122845|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
71810576|NCT02954354|143122845|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
71810577|NCT02954354|143122845|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
71810578|NCT02954354|143122845|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
71810579|NCT02954354|143122845|SUPERIORITY|||||||0.4767||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.4767
71810580|NCT02954354|143122845|SUPERIORITY|||||||0.3353||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3353
71810581|NCT02954354|143122846|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
71810582|NCT02954354|143122846|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
71810583|NCT02954354|143122846|SUPERIORITY|||||||0.0852||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0852
71810584|NCT02954354|143122846|SUPERIORITY|||||||0.0063||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0063
71810585|NCT02954354|143122846|SUPERIORITY|||||||0.6187||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.6187
71810586|NCT02954354|143122846|SUPERIORITY|||||||0.8637||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|||Day 9||||0.8637
71810587|NCT02954354|143122847|SUPERIORITY|||||||0.6145||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.6145
71810588|NCT02954354|143122847|SUPERIORITY|||||||0.2505||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.2505
71810589|NCT02954354|143122847|SUPERIORITY|||||||0.419||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4190
71810590|NCT02954354|143122847|SUPERIORITY|||||||0.0095||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0095
71810591|NCT02954354|143122847|SUPERIORITY|||||||0.7393||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.7393
71810592|NCT02954354|143122847|SUPERIORITY|||||||0.0049||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0049
71810593|NCT02954354|143122848|SUPERIORITY|||||||0.2266||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||0.2266
71810594|NCT02954354|143122848|SUPERIORITY|||||||0.1379||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||0.1379
71810595|NCT02954354|143122848|SUPERIORITY|||||||0.5479||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.5479
71810596|NCT02954354|143122848|SUPERIORITY|||||||0.0241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0241
71810597|NCT02954354|143122848|SUPERIORITY|||||||0.0898||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0898
71844072|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.4|2.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||2.8|-1.4|
71844073|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.5|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||2.7|-1.5|
71844074|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.8|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||2.4|-1.8|
71844075|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||2.5|-1.8|
71896333|NCT03114969|143314794|SUPERIORITY||Odds Ratio (OR)|9.991||||0.13|TWO_SIDED|95.0|0.508|196.435||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||196.435|0.508|0.130
71810598|NCT02954354|143122848|SUPERIORITY|||||||0.2548||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.2548
71810599|NCT02954354|143122849|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
71810600|NCT02954354|143122849|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
71810601|NCT02954354|143122849|SUPERIORITY|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.0008
71844076|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||2.4|-1.9|
71844077|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||2.5|-1.9|
71810602|NCT02954354|143122849|SUPERIORITY|||||||0.0132||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0132
71810603|NCT02954354|143122849|SUPERIORITY|||||||0.9307||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9307
71895434|NCT01157169|143313425|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.91|||||TWO_SIDED|90.0|99.74|112.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||112.45|99.74|
71895435|NCT01157169|143313426|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.97|||||TWO_SIDED|90.0|97.18|111.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.24|97.18|
71895436|NCT01157169|143313427|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.28|||||TWO_SIDED|90.0|85.37|101.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.93|85.37|
71895437|NCT01157169|143313428|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||TWO_SIDED|90.0|87.44|101.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||101.46|87.44|
71895438|NCT01157169|143313429|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.06|||||TWO_SIDED|90.0|86.56|104.39|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||104.39|86.56|
71895439|NCT02396147|143313437|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|87.09|||||TWO_SIDED|90.0|58.56|129.52|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference)\*100|||129.52|58.56|
71895440|NCT02396147|143313437|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|83.09|||||TWO_SIDED|90.0|59.95|115.18|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||115.18|59.95|
71810604|NCT02954354|143122849|SUPERIORITY|||||||0.1677||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.1677
71810605|NCT02954354|143122850|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
71810606|NCT02954354|143122850|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
71810607|NCT02954354|143122850|SUPERIORITY|||||||0.801||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.8010
71810608|NCT02954354|143122850|SUPERIORITY|||||||0.9451||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.9451
71810609|NCT02954354|143122850|SUPERIORITY|||||||0.2256||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.2256
71810610|NCT02954354|143122850|SUPERIORITY|||||||0.3332||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.3332
71810611|NCT02954354|143122851|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
71810612|NCT02954354|143122851|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
71813901|NCT02799472|143129766|OTHER||Mean Difference (Net)|-547.6||||0.875|TWO_SIDED|95.0|-7612.6|6517.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 4||6517.3|-7612.6|0.875
71810613|NCT02954354|143122851|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||<0.0001
71810614|NCT02954354|143122851|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||<0.0001
71810615|NCT02954354|143122851|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.0010
71810616|NCT02954354|143122851|SUPERIORITY|||||||0.0002||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.0002
71810617|NCT02954354|143122852|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2||||<0.0001
71810618|NCT02954354|143122852|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3||||<0.0001
71810619|NCT02954354|143122852|SUPERIORITY|||||||0.4148||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4||||0.4148
71813902|NCT02799472|143129766|OTHER||Mean Difference (Net)|-1106.0||||0.815|TWO_SIDED|95.0|-10706.0|8494.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 12||8494.1|-10706.0|0.815
71813903|NCT02799472|143129766|OTHER||Mean Difference (Net)|-3631.0||||0.23|TWO_SIDED|95.0|-9738.9|2476.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, 12-Week FU||2476.8|-9738.9|0.230
71813904|NCT02799472|143129766|OTHER||Mean Difference (Net)|-515.6||||0.489|TWO_SIDED|95.0|-2021.4|990.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 1||990.1|-2021.4|0.489
71813905|NCT02799472|143129766|OTHER||Mean Difference (Net)|-199.8||||0.822|TWO_SIDED|95.0|-2001.7|1602.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 4||1602.0|-2001.7|0.822
71813906|NCT02799472|143129766|OTHER||Mean Difference (Net)|-253.5||||0.784|TWO_SIDED|95.0|-2136.7|1629.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 12||1629.7|-2136.7|0.784
71813907|NCT02799472|143129766|OTHER||Mean Difference (Net)|225.1||||0.804|TWO_SIDED|95.0|-1633.1|2083.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, 12-Week FU||2083.2|-1633.1|0.804
71813908|NCT02799472|143129766|OTHER||Mean Difference (Net)|162.7||||0.719|TWO_SIDED|95.0|-754.5|1079.9|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 1||1079.9|-754.5|0.719
71813909|NCT02799472|143129766|OTHER||Mean Difference (Net)|-183.5||||0.742|TWO_SIDED|95.0|-1317.4|950.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 4||950.3|-1317.4|0.742
71813910|NCT02799472|143129766|OTHER||Mean Difference (Net)|-268.5||||0.658|TWO_SIDED|95.0|-1507.5|970.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 12||970.5|-1507.5|0.658
71813911|NCT02799472|143129766|OTHER||Mean Difference (Net)|-197.6||||0.755|TWO_SIDED|95.0|-1499.3|1104.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, 12-Week FU||1104.2|-1499.3|0.755
71813912|NCT02799472|143129766|OTHER||Mean Difference (Net)|1150.0||||0.333|TWO_SIDED|95.0|-1250.0|3550.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 1||3550.0|-1250.0|0.333
71813913|NCT02799472|143129766|OTHER||Mean Difference (Net)|-268.0||||0.891|TWO_SIDED|95.0|-4269.2|3733.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 4||3733.3|-4269.2|0.891
71813914|NCT02799472|143129766|OTHER||Mean Difference (Net)|-1347.4||||0.633|TWO_SIDED|95.0|-7073.1|4378.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 12||4378.3|-7073.1|0.633
71813915|NCT02799472|143129766|OTHER||Mean Difference (Net)|-1688.9||||0.41|TWO_SIDED|95.0|-5864.1|2486.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, 12-Week FU||2486.2|-5864.1|0.410
71813916|NCT02799472|143129766|OTHER||Mean Difference (Net)|3276.8||||0.196|TWO_SIDED|95.0|-1786.0|8339.6|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 1||8339.6|-1786.0|0.196
71813917|NCT02799472|143129766|OTHER||Mean Difference (Net)|-447.3||||0.894|TWO_SIDED|95.0|-7285.5|6390.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 4||6390.8|-7285.5|0.894
71813918|NCT02799472|143129766|OTHER||Mean Difference (Net)|1435.3||||0.6|TWO_SIDED|95.0|-4101.4|6972.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 12||6972.0|-4101.4|0.600
71813919|NCT02799472|143129766|OTHER||Mean Difference (Net)|-1210.2||||0.534|TWO_SIDED|95.0|-5213.1|2792.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, 12-Week FU||2792.7|-5213.1|0.534
71813920|NCT02799472|143129767|OTHER||Mean Difference (Net)|2756.3||||0.328|TWO_SIDED|95.0|-2953.7|8466.3|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 1||8466.3|-2953.7|0.328
71813921|NCT02799472|143129767|OTHER||Mean Difference (Net)|-487.5||||0.895|TWO_SIDED|95.0|-8003.7|7028.6|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 4||7028.6|-8003.7|0.895
71813922|NCT02799472|143129767|OTHER||Mean Difference (Net)|-277.4||||0.961|TWO_SIDED|95.0|-12001.0|11446.2|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 12||11446.2|-12001.0|0.961
71813923|NCT02799472|143129767|OTHER||Mean Difference (Net)|-311.6||||0.956|TWO_SIDED|95.0|-11960.5|11337.4|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, 12-Week FU||11337.4|-11960.5|0.956
71810620|NCT02954354|143122852|SUPERIORITY|||||||0.0338||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5||||0.0338
71810621|NCT02954354|143122852|SUPERIORITY|||||||0.9619||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6||||0.9619
71810622|NCT02954354|143122852|SUPERIORITY|||||||0.8491||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9||||0.8491
71844078|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-1.8|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||2.5|-1.8|
71844079|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.12|||TWO_SIDED|95.0|-1.9|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.5|-1.9|
71844080|NCT02307682|143202435|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-1.6|2.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||2.7|-1.6|
71844081|NCT02307682|143202436|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-1.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||1.1|-1.9|
71844082|NCT02307682|143202436|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-1.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||1.6|-1.5|
71844083|NCT02307682|143202436|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-1.8|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||1.6|-1.8|
71844084|NCT02307682|143202436|OTHER|Treatment difference|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.88|||TWO_SIDED|95.0|-1.7|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||1.8|-1.7|
71844085|NCT02307682|143202437|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|95.0|-2.0|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 48||1.2|-2.0|
71844086|NCT02307682|143202437|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.6|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||1.8|-1.6|
71810623|NCT02954354|143122853|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
71810624|NCT02954354|143122854|SUPERIORITY|||||||0.0313||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0313
71844087|NCT02307682|143202437|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 96||1.7|-1.9|
71844088|NCT02307682|143202437|OTHER|Treatment difference|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-1.7|1.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 96||1.9|-1.7|
71844089|NCT02307682|143202438|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||2.5|-1.7|
71844090|NCT02307682|143202438|OTHER|Treatment difference|Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|95.0|-1.7|2.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||2.5|-1.7|
71844091|NCT02307682|143202439|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.2|-4.2|
71895441|NCT02396147|143313437|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.59|||||TWO_SIDED|90.0|52.88|116.79|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||116.79|52.88|
71676525|NCT00769067|142870915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.822||||0.252|TWO_SIDED|95.0|0.587|1.151||2-Sided.|Log Rank|Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.||1.151|0.587|0.252
71676526|NCT03806933|142870916|OTHER||Hazard Ratio (HR)|1.03|||=|0.881|TWO_SIDED|95.0|0.7|1.51||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||Hazard ratio (HR) was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.51|0.7|= 0.881
71810625|NCT02954354|143122855|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
71810626|NCT02954354|143122856|SUPERIORITY|||||||0.2424||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.2424
71810627|NCT02954354|143122857|SUPERIORITY||Difference|-72.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-48.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-48.0|-72.0|<0.0001
71810628|NCT02954354|143122858|SUPERIORITY||Difference|-48.0|||<|0.0001|TWO_SIDED|95.0|-72.0|-24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-24.0|-72.0|<0.0001
71810629|NCT02954354|143122859|SUPERIORITY||Difference|-24.0||||0.002|TWO_SIDED|95.0|-120.0|0.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||0.0|-120.0|0.0020
71810630|NCT02954354|143122860|SUPERIORITY||Difference|-24.0||||0.0102|TWO_SIDED|95.0|-48.0|24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||24.0|-48.0|0.0102
71844092|NCT02307682|143202439|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.8|-2.8|
71844093|NCT02307682|143202439|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.4|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.9|-4.4|
71844094|NCT02307682|143202439|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-1.2|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||10.0|-1.2|
71676527|NCT03806933|142870916|OTHER||Hazard Ratio (HR)|0.72|||=|0.089|TWO_SIDED|95.0|0.49|1.05||P-values were based on Wald Chi-Square tests for hazard ratios.|Wald Chi-square test||HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||1.05|0.49|= 0.089
71810631|NCT02954354|143122861|SUPERIORITY|||||||0.5973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.5973
71810632|NCT02954354|143122861|SUPERIORITY|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.0010
71810633|NCT02954354|143122861|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
71810634|NCT02954354|143122861|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
71810635|NCT02954354|143122861|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
71844095|NCT02307682|143202439|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-5.9|
71844096|NCT02307682|143202439|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-0.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||11.0|-0.5|
71895442|NCT02396147|143313437|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.23|||||TWO_SIDED|90.0|67.98|130.61|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||130.61|67.98|
71676528|NCT03806933|142870916|OTHER||Hazard Ratio (HR)|0.56||||0.0035|TWO_SIDED|95.0|0.38|0.83|||Wald Chi-square test|P-values were based on Wald Chi-Square tests for hazard ratios.|HR was estimated using a Cox proportional hazards regression model. 95% CIs were calculated based on individual Wald tests.|||0.83|0.38|0.0035
71810636|NCT02954354|143122861|SUPERIORITY|||||||0.0115||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.0115
71810637|NCT02954354|143122861|SUPERIORITY|||||||0.1298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.1298
71810638|NCT02954354|143122861|SUPERIORITY|||||||0.117||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.1170
71810639|NCT02954354|143122861|SUPERIORITY|||||||0.0757||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.0757
71810640|NCT02954354|143122861|SUPERIORITY|||||||0.9453||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.9453
71810641|NCT02954354|143122861|SUPERIORITY|||||||0.8657||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.8657
71810642|NCT02954354|143122862|SUPERIORITY|||||||0.0458||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.0458
71810643|NCT02954354|143122862|SUPERIORITY|||||||0.7565||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.7565
71810644|NCT02954354|143122862|SUPERIORITY|||||||0.3297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.3297
71810645|NCT02954354|143122862|SUPERIORITY|||||||0.4442||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||0.4442
71810646|NCT02954354|143122862|SUPERIORITY|||||||0.6029||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.6029
71810647|NCT02954354|143122862|SUPERIORITY|||||||0.9881||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.9881
71810648|NCT02954354|143122862|SUPERIORITY|||||||0.9257||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.9257
71810649|NCT02954354|143122862|SUPERIORITY|||||||0.5317||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.5317
71810650|NCT02954354|143122862|SUPERIORITY|||||||0.2144||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2144
71810651|NCT02954354|143122862|SUPERIORITY|||||||0.0413||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.0413
71810652|NCT02954354|143122862|SUPERIORITY|||||||0.0409||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.0409
71676529|NCT03625466|142870928|SUPERIORITY||Mean Difference|-1.5|||||TWO_SIDED|95.0|-5.5|2.6||||||||2.6|-5.5|
71676530|NCT01058993|142870938|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|Student t-test-comparison means of normal subjects \& controls.||||||<0.05
71676531|NCT01058993|142870938|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Ratio paired t-test|Ratio paired t-test for comparison of baselines and responses for each category of leukocytes||The patients' leukocyte counts before and after plerixafor were compared.||||<0.05
71676532|NCT00394836|142870961|SUPERIORITY_OR_OTHER||percentage of responders|13.0|||||TWO_SIDED|95.0|4.0|31.0|||||Response rate is calculated as the number of responses divided by the number of participants treated \* 100.|||31|4|
71676533|NCT00394836|142870961|SUPERIORITY_OR_OTHER||percentage of responders|10.0|||||TWO_SIDED|95.0|5.0|19.0||||||||19|5|
71676534|NCT04932655|142870994|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|103.22|||||TWO_SIDED|90.0|96.88|109.98||||||||109.98|96.88|
71676535|NCT04932655|142870994|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|109.64|||||TWO_SIDED|90.0|102.9|116.82||||||||116.82|102.9|
71676536|NCT04932655|142870994|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|102.9|||||TWO_SIDED|90.0|96.57|109.64||||||||109.64|96.57|
71676537|NCT04932655|142870995|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.47|||||TWO_SIDED|90.0|96.33|100.65||||||||100.65|96.33|
71810653|NCT02954354|143122863|SUPERIORITY||Difference|-19.8|||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
71810654|NCT02954354|143122864|SUPERIORITY||Difference|-0.7||||0.4194||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4194
71810655|NCT02954354|143122865|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-23.1|||<|0.0001|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||<0.0001
71676538|NCT04932655|142870995|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.88|||||TWO_SIDED|90.0|96.74|101.07||||||||101.07|96.74|
71676539|NCT04932655|142870995|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.32|||||TWO_SIDED|90.0|98.15|102.54||||||||102.54|98.15|
71810656|NCT02954354|143122866|SUPERIORITY||Difference|1.3||||0.4856||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.4856
71810657|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7173|TWO_SIDED|95.0|-0.5|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.7|-0.5|0.7173
71810658|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.3||0.0009|TWO_SIDED|95.0|-1.7|-0.4||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||-0.4|-1.7|0.0009
71895443|NCT02396147|143313438|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.53|||||TWO_SIDED|90.0|74.83|119.4|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (Reference) \*100|||119.40|74.83|
71676540|NCT04932655|142870996|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|98.5|||||TWO_SIDED|90.0|96.33|100.71||||||||100.71|96.33|
71676541|NCT04932655|142870996|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|99.03|||||TWO_SIDED|90.0|96.85|101.26||||||||101.26|96.85|
71676542|NCT04932655|142870996|EQUIVALENCE|Two one-sided t test procedure used to compare test versus reference. Equivalence demonstrated if 90% CI within 80% to 125%.|Test/Reference Ratio of Geometric Means|100.25|||||TWO_SIDED|90.0|98.05|102.5||||||||102.50|98.05|
71676543|NCT01665157|142870997|SUPERIORITY_OR_OTHER|||||||0.435||||||Not significant|ANOVA|||||||0.435
71676544|NCT01665157|142870998|SUPERIORITY_OR_OTHER|||||||0.046|||||||Chi-squared|||||||0.046
71676545|NCT01665157|142870998|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||"Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality."||||0.024
71676546|NCT01665157|142870998|SUPERIORITY_OR_OTHER|||||||0.041|||||||Chi-squared|||||||0.041
71676547|NCT01665157|142871001|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<0.01
71676548|NCT01665157|142871002|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<0.01
71676549|NCT01665157|142871003|SUPERIORITY_OR_OTHER|||||||0.025|||||||Chi-squared|||||||0.025
71676550|NCT02780713|142871012|SUPERIORITY||Percentage|17.02|||||TWO_SIDED|95.0|11.79|24.58||||||||24.58|11.79|
71676551|NCT02780713|142871012|SUPERIORITY||Percentage|36.28|||||TWO_SIDED|95.0|23.84|55.2||||||||55.20|23.84|
71676552|NCT02780713|142871012|SUPERIORITY||Percentage|24.1|||||TWO_SIDED|95.0|16.84|34.48||||||||34.48|16.84|
71676553|NCT02780713|142871013|SUPERIORITY||Percentage|31.75|||||TWO_SIDED|95.0|25.77|39.12||||||||39.12|25.77|
71676554|NCT02780713|142871013|SUPERIORITY||Percentage|54.17|||||TWO_SIDED|95.0|42.16|69.6||||||||69.60|42.16|
71676555|NCT02780713|142871013|SUPERIORITY||Pecentage|41.23|||||TWO_SIDED|95.0|34.79|48.86||||||||48.86|34.79|
71895444|NCT02396147|143313438|SUPERIORITY_OR_OTHER||Geometric Mean Ration|77.99|||||TWO_SIDED|90.0|64.29|94.61|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.61|64.29|
71676556|NCT02111577|142871025|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and Eastern Cooperative Oncology Group (ECOG) score (0, 1 vs 2)|Hazard Ratio (HR)|1.042||||0.596|TWO_SIDED|95.0|0.895|1.213|||Log Rank|||Stratified||1.213|0.895|0.596
71676557|NCT02111577|142871025|SUPERIORITY||Hazard Ratio (HR)|1.036||||0.648|TWO_SIDED|95.0|0.891|1.204|||Log Rank|||Unstratified||1.204|0.891|0.648
71810659|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||-1.1|-2.4|<0.0001
71810660|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.4|-1.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||-1.2|-2.4|<0.0001
71810661|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.0|-0.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||-0.9|-2.0|<0.0001
71810662|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.5|-0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||-0.5|-1.5|0.0001
71676558|NCT02111577|142871026|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.908||||0.335|TWO_SIDED|95.0|0.746|1.105|||Log Rank|||Stratified||1.105|0.746|0.335
71810663|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1979|TWO_SIDED|95.0|-0.8|0.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.2|-0.8|0.1979
71810664|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.1079|TWO_SIDED|95.0|-0.8|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.1|-0.8|0.1079
71810665|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5805|TWO_SIDED|95.0|-0.6|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.3|-0.6|0.5805
71810666|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.8057|TWO_SIDED|95.0|-0.4|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.5|-0.4|0.8057
71810667|NCT02954354|143122867|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9525|TWO_SIDED|95.0|-0.6|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.6|0.9525
71810668|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4091|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours||0.8|-0.3|0.4091
71810669|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3073|TWO_SIDED|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours||0.8|-0.3|0.3073
71810670|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3465|TWO_SIDED|95.0|-0.8|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours||0.3|-0.8|0.3465
71813924|NCT02799472|143129767|OTHER||Mean Difference (Net)|6866.9||||0.212|TWO_SIDED|95.0|-4230.7|17964.6|||Repeated measures analysis|||CD14br+CD16+, Week 1||17964.6|-4230.7|0.212
71813925|NCT02799472|143129767|OTHER||Mean Difference (Net)|8359.6||||0.227|TWO_SIDED|95.0|-5533.3|22252.5|||Repeated measures analysis|||CD14br+CD16+, Week 4||22252.5|-5533.3|0.227
71895445|NCT02396147|143313438|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.08|||||TWO_SIDED|90.0|64.21|102.37|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.37|64.21|
71895446|NCT02396147|143313438|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.78|||||TWO_SIDED|90.0|76.48|112.55|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.55|76.48|
71676559|NCT02111577|142871026|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.192|TWO_SIDED|95.0|0.725|1.067|||Log Rank|||Unstratified||1.067|0.725|0.192
71676560|NCT02111577|142871027|SUPERIORITY|Stratified by region (US vs other), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.312||||0.071|TWO_SIDED|95.0|0.976|1.762|||Log Rank|||Stratified||1.762|0.976|0.071
71810671|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.4285|TWO_SIDED|95.0|-0.3|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours||0.7|-0.3|0.4285
71810672|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6703|TWO_SIDED|95.0|-0.4|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours||0.6|-0.4|0.6703
71810673|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7187|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours||0.5|-0.3|0.7187
71810674|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.135|TWO_SIDED|95.0|-0.1|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours||0.7|-0.1|0.1350
71810675|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.7046|TWO_SIDED|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours||0.5|-0.3|0.7046
71810676|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.2765|TWO_SIDED|95.0|-0.2|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours||0.6|-0.2|0.2765
71810677|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0274|TWO_SIDED|95.0|0.0|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours||0.8|0.0|0.0274
71810678|NCT02954354|143122868|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6001|TWO_SIDED|95.0|-0.3|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours||0.6|-0.3|0.6001
71810679|NCT02954354|143122869|SUPERIORITY||Difference|-17.5|||<|0.0001|TWO_SIDED|95.0|-21.1|-11.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||-11.9|-21.1|<0.0001
71676561|NCT02111577|142871027|SUPERIORITY||Hazard Ratio (HR)|1.283||||0.09|TWO_SIDED|95.0|0.961|1.712|||Log Rank|||Unstratified||1.712|0.961|0.09
71810680|NCT02954354|143122870|SUPERIORITY|||||||0.9225||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.9225
71810681|NCT02954354|143122871|SUPERIORITY|||||||0.7866||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.7866
71810682|NCT02954354|143122871|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||<0.0001
71810683|NCT02954354|143122871|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||<0.0001
71810684|NCT02954354|143122871|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours||||<0.0001
71810685|NCT02954354|143122871|SUPERIORITY||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||<0.0001
71810686|NCT02954354|143122871|SUPERIORITY|||||||0.7044||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours||||0.7044
71810687|NCT02954354|143122871|SUPERIORITY|||||||0.8512||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.8512
71810688|NCT02954354|143122871|SUPERIORITY|||||||0.8783||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours||||0.8783
71676562|NCT02111577|142871028|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.461||||0.049|TWO_SIDED|95.0|1.0|2.134|||Log Rank|||Stratified||2.134|1|0.049
71810689|NCT02954354|143122871|SUPERIORITY|||||||0.8291||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.8291
71810690|NCT02954354|143122871|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
71810691|NCT02954354|143122871|SUPERIORITY|||||||0.9312||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.9312
71810692|NCT02954354|143122872|SUPERIORITY|||||||0.2953||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours||||0.2953
71810693|NCT02954354|143122872|SUPERIORITY|||||||0.5414||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours||||0.5414
71810694|NCT02954354|143122872|SUPERIORITY|||||||0.2079||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours||||0.2079
71676563|NCT02111577|142871028|SUPERIORITY||Hazard Ratio (HR)|1.436||||0.053|TWO_SIDED|95.0|0.993|2.077|||Log Rank|||Unstratified||2.077|0.993|0.053
71810695|NCT02954354|143122872|SUPERIORITY|||||||0.7771||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||48 hours||||0.7771
71810696|NCT02954354|143122872|SUPERIORITY|||||||0.0215||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours||||0.0215
71810697|NCT02954354|143122872|SUPERIORITY|||||||0.8033||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||96 hours||||0.8033
71810698|NCT02954354|143122872|SUPERIORITY|||||||0.4157||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours||||0.4157
71810699|NCT02954354|143122872|SUPERIORITY|||||||0.5908||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||144 hours||||0.5908
71810700|NCT02954354|143122872|SUPERIORITY|||||||0.2975||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours||||0.2975
71810701|NCT02954354|143122872|SUPERIORITY|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours||||0.8644
71810702|NCT02954354|143122872|SUPERIORITY|||||||0.5573||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.m|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours||||0.5573
71810703|NCT02954354|143122873|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.08||0.2557|TWO_SIDED|95.0|-0.24|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.06|-0.24|0.2557
71810704|NCT02954354|143122873|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.46|-0.22||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||-0.22|-0.46|<0.0001
71676564|NCT02111577|142871029|SUPERIORITY|Stratified by region (US vs other) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.938||||0.501|TWO_SIDED|95.0|0.779|1.13|||Log Rank|||Stratified||1.13|0.779|0.501
71810705|NCT02954354|143122873|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.52|-0.29||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||-0.29|-0.52|<0.0001
71813926|NCT02799472|143129767|OTHER||Mean Difference (Net)|-22683.6||||0.04|TWO_SIDED|95.0|-44298.5|-1068.8|||Repeated measures analysis|||CD14br+CD16+, Week 12||-1068.8|-44298.5|0.040
71813927|NCT02799472|143129767|OTHER||Mean Difference (Net)|-3757.2||||0.741|TWO_SIDED|95.0|-27146.0|19631.6|||Repeated measures analysis|||CD14br+CD16+, 12-Week FU||19631.6|-27146.0|0.741
71813928|NCT02799472|143129767|OTHER||Mean Difference (Net)|-22417.0||||0.628|TWO_SIDED|95.0|-116677.8|71843.8|||Repeated measures analysis|||CD14br+CD16-, Week 1||71843.8|-116677.8|0.628
71813929|NCT02799472|143129767|OTHER||Mean Difference (Net)|27659.7||||0.321|TWO_SIDED|95.0|-28567.8|83887.1|||Repeated measures analysis|||CD14br+CD16-, Week 4||83887.1|-28567.8|0.321
71813930|NCT02799472|143129767|OTHER||Mean Difference (Net)|16182.9||||0.704|TWO_SIDED|95.0|-70377.0|102742.9|||Repeated measures analysis|||CD14br+CD16-, Week 12||102742.9|-70377.0|0.704
71810706|NCT02954354|143122873|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.48|-0.27||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||-0.27|-0.48|<0.0001
71810707|NCT02954354|143122873|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.31|-0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||-0.13|-0.31|<0.0001
71810708|NCT02954354|143122873|SUPERIORITY||LS Mean Dfference|-0.04|STANDARD_ERROR_OF_MEAN|0.05||0.4484|TWO_SIDED|95.0|-0.13|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.06|-0.13|0.4484
71810709|NCT02954354|143122873|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.5963|TWO_SIDED|95.0|-0.07|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||0.11|-0.07|0.5963
71810710|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.07||0.0937|TWO_SIDED|95.0|-0.02|0.24||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours||0.24|-0.02|0.0937
71810711|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3343|TWO_SIDED|95.0|-0.05|0.16||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours||0.16|-0.05|0.3343
71810712|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9258|TWO_SIDED|95.0|-0.09|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours||0.10|-0.09|0.9258
71810713|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.6574|TWO_SIDED|95.0|-0.1|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours||0.06|-0.10|0.6574
71810714|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.852|TWO_SIDED|95.0|-0.09|0.07||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours||0.07|-0.09|0.8520
71810715|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4532|TWO_SIDED|95.0|-0.05|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours||0.11|-0.05|0.4532
71810716|NCT02954354|143122874|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.04||0.157|TWO_SIDED|95.0|-0.02|0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||120 hours||0.13|-0.02|0.1570
71810717|NCT02954354|143122875|SUPERIORITY||Difference|-23.1||||0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.0001
71810718|NCT02954354|143122875|SUPERIORITY||Difference|-9.0||||0.0298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.0298
71810719|NCT02954354|143122875|SUPERIORITY||Difference|-11.8||||0.0297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.0297
71810720|NCT02954354|143122875|SUPERIORITY||Difference|-20.7||||0.0027||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal Congestion||||0.0027
71810721|NCT02954354|143122875|SUPERIORITY||Difference|-4.9||||0.0003||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||Feverishness or chills||||0.0003
71813931|NCT02799472|143129767|OTHER||Mean Difference (Net)|-63419.4||||0.232|TWO_SIDED|95.0|-170364.9|43526.1|||Repeated measures analysis|||CD14br+CD16-, 12-Week FU||43526.1|-170364.9|0.232
71813932|NCT02799472|143129767|OTHER||Mean Difference (Net)|-6913.6||||0.366|TWO_SIDED|95.0|-22588.4|8761.1|||Repeated measures analysis|||CD14lo+CD16br+, Week 1||8761.1|-22588.4|0.366
71813933|NCT02799472|143129767|OTHER||Mean Difference (Net)|-2231.6||||0.603|TWO_SIDED|95.0|-10976.8|6513.6|||Repeated measures analysis|||CD14lo+CD16br+, Week 4||6513.6|-10976.8|0.603
71813934|NCT02799472|143129767|OTHER||Mean Difference (Net)|-10179.1||||0.084|TWO_SIDED|95.0|-21827.4|1469.2|||Repeated measures analysis|||CD14lo+CD16br+, Week 12||1469.2|-21827.4|0.084
71676565|NCT02111577|142871029|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.512|TWO_SIDED|95.0|0.781|1.131|||Log Rank|||Unstratified||1.131|0.781|0.512
71676566|NCT02111577|142871030|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.99||||0.886|TWO_SIDED|95.0|0.863|1.136|||Log Rank|||Stratified||1.136|0.863|0.886
71810722|NCT02954354|143122875|SUPERIORITY||Difference|-8.1||||0.0094||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.0094
71810723|NCT02954354|143122875|SUPERIORITY||Difference|-15.3||||0.0007||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.0007
71810724|NCT02954354|143122876|SUPERIORITY||Difference|6.8||||0.6623||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough||||0.6623
71810725|NCT02954354|143122876|SUPERIORITY||Difference|1.8||||0.8184||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat||||0.8184
71810726|NCT02954354|143122876|SUPERIORITY||Difference|1.3||||0.9989||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache||||0.9989
71810727|NCT02954354|143122876|SUPERIORITY||Difference|1.7||||0.3706||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal congestion||||0.3706
71810728|NCT02954354|143122876|SUPERIORITY||Difference|-0.1||||0.9973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Feverishness or chills||||0.9973
71844097|NCT02307682|143202439|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.0|-3.7|
71810729|NCT02954354|143122876|SUPERIORITY||Difference|-0.7||||0.676||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain||||0.6760
71810730|NCT02954354|143122876|SUPERIORITY||Difference|2.2||||0.4241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue||||0.4241
71810731|NCT02954354|143122877|SUPERIORITY|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-39.5||||0.0563|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.0563
71810732|NCT02954354|143122878|SUPERIORITY||Difference|-0.6||||0.7176||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||||||0.7176
71810733|NCT02954354|143122879|SUPERIORITY|||||||0.6728||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.6728
71810734|NCT02954354|143122880|SUPERIORITY|||||||0.2217||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications||||0.2217
71810735|NCT00715429|143122958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||||||Daily cramp rate at baseline\& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.|t-test, 2 sided|T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.||||||0.27
71895447|NCT02396147|143313439|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|94.43|||||TWO_SIDED|90.0|74.85|119.12|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference) \* 100|||119.12|74.85|
71676567|NCT02111577|142871030|SUPERIORITY||Hazard Ratio (HR)|1.001||||0.992|TWO_SIDED|95.0|0.875|1.145|||Log Rank|||Unstratified||1.145|0.875|0.992
71676568|NCT02111577|142871031|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.001||||0.994|TWO_SIDED|95.0|0.847|1.184|||Log Rank|||Stratified||1.184|0.847|0.994
71676569|NCT02111577|142871031|SUPERIORITY||Hazard Ratio (HR)|1.002||||0.982|TWO_SIDED|95.0|0.851|1.18|||Log Rank|||Unstratified||1.18|0.851|0.982
71676570|NCT02111577|142871032|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.077||||0.392|TWO_SIDED|95.0|0.909|1.277|||Log Rank|||Stratified||1.277|0.909|0.392
71810736|NCT04085328|143122962|NON_INFERIORITY|Predefined margin of 0.05 for noninferiority|Difference in proportion|-0.0154|||||ONE_SIDED|95.0||-0.0015|||Generalized linear model|Proportion of events was analyzed using a generalized linear model, with a logit link function, accounting for within-subject correlation.|Difference in proportion = LID015385 minus Biofinity.|||-0.0015||
71895448|NCT02396147|143313439|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|78.09|||||TWO_SIDED|90.0|64.53|94.51|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) \* 100|||94.51|64.53|
71810737|NCT00514735|143122963|SUPERIORITY_OR_OTHER||||||<|0.0001||||||In order to maintain the overall level of significance at the α=0.025 level after a planned interim analysis using α=0.003, this test will actually be performed using an adjusted α=0.0245 at the completion of the study.|Chi-squared|||"H0: Pa ≤ Pm Ha: Pa \> Pm~where Pa is the proportion of successfully treated subjects in the ablation management arm and Pm is the proportion of successfully treated subjects in the optimal medical management/drug therapy arm."||||<0.0001
71810738|NCT00514735|143122964|SUPERIORITY_OR_OTHER|||||||0.1427||||||An exact, one-sample binomial test was conducted at a one-sided α=0.025 level of significance.|Fisher Exact|||"H0: Pa ≥ 0.16 Ha: Pa \< 0.16~where Pa is the proportion of acute safety failures in the ablation management arm."||||0.1427
71810739|NCT00514735|143122965|NON_INFERIORITY_OR_EQUIVALENCE|This objective was not statistically powered. The non-inferiority chronic safety margin was 0.06.||||||0.0033|||||||t-test, 1 sided|||"H0: Pa ≥ Pm + 0.06 Ha: Pa \< Pm + 0.06~where Pa is the proportion of failed subjects in the ablation management arm and Pm is the proportion of failed subjects in the optimal medical management/drug therapy arm."||||0.0033
71810740|NCT00514735|143122967|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LAD from baseline to 6 month in Ablation Management arm, and μm is the change of LAD from baseline to 6 month in Medical Management arm."||||0.35
71810741|NCT00514735|143122968|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LVEF from baseline to 6 month in Ablation Management arm, and μm is the change of LVEF from baseline to 6 month in Medical Management arm."||||0.06
71810742|NCT00514735|143122969|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71810743|NCT00514735|143122970|SUPERIORITY_OR_OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
71810744|NCT02170025|143122971|OTHER||Bayesian analysis|-1.3|||||TWO_SIDED|90.0|-8.7|6.0||||||Treatment effect describes the difference in outcomes between 0.5 mg riociguat and placebo on Day 14. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||6.0|-8.7|
71844098|NCT02307682|143202439|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.3|-3.8|
71844099|NCT02307682|143202439|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.1|-5.9|
71810745|NCT02170025|143122971|OTHER||Bayesian analysis|-5.0|||||TWO_SIDED|90.0|-12.4|2.4||||||Treatment effect describes the difference in outcomes between 1.0 mg riociguat and placebo on Day 28. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.||2.4|-12.4|
71810746|NCT00572195|143122973|OTHER||Wilson score interval|77.0|||||TWO_SIDED|95.0|71.1|81.9|||||The value is for all serious adverse events, regardless of device relation.||95% confidence interval estimated using the Wilson score interval|81.9|71.1|
71810747|NCT00572195|143122974|OTHER||||||<|0.05||||||For all 6-month periods, from 6 months through 9 years post-implant, p \<0.05.|Wilcoxon Signed Rank Test|||||||<0.05
71810748|NCT00572195|143122976|OTHER||GEE estimated intercept|48.0|||<|0.0001|TWO_SIDED|95.0|46.8|49.2|||Generalized estimating equation (GEE)|||||49.2|46.8|<0.0001
71810749|NCT00572195|143122976|OTHER||Slope|0.0||||0.6729|TWO_SIDED|95.0|-0.2|0.1|||Generalized estimating equation (GEE)|||||0.1|-0.2|0.6729
71810750|NCT00876915|143122988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.4795|TWO_SIDED|95.0|0.235|1.89|||stratified Cox|||||1.890|0.235|0.4795
71810751|NCT00876915|143122989|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.019||||0.0252|TWO_SIDED|95.0|1.236|131.632|||stratified Cox|||||131.632|1.236|0.0252
71844100|NCT02307682|143202439|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.4|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.4|
71895449|NCT02396147|143313439|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|81.16|||||TWO_SIDED|90.0|64.36|102.34|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) \* 100|||102.34|64.36|
71810752|NCT04128293|143123002|OTHER||Ratio of Geometric Least Square Mean|0.877|||||TWO_SIDED|90.0|0.7585|1.0152|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-infinity).|||1.0152|0.7585|
71810753|NCT04128293|143123004|OTHER||Ratio of Geometric Least Square Mean|0.892|||||TWO_SIDED|90.0|0.7778|1.0239|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of AUC(0-t).|||1.0239|0.7778|
71810754|NCT04128293|143123006|OTHER||Ratio of Geometric Least Square Mean|0.946|||||TWO_SIDED|90.0|0.8594|1.0404|||||Relative bioavailability between treatment A and B assessed using analysis of variance with treatment, period, and sequence as fixed effects, participant as a random effect was performed on the natural log-transformed parameter of Cmax.|||1.0404|0.8594|
71810755|NCT04128293|143123009|OTHER||Median Difference (Final Values)|0.533||||0.4252|TWO_SIDED|90.0|-1.0|2.0||The p-value was assessed based on the Wilcoxon signed-rank test.|Wilcoxon signed-rank test||The median difference and the 90 percent (%) confidence interval of the median difference was estimated from Hodges-Lehmann estimate.|||2.0000|-1.0000|0.4252
71810756|NCT04128293|143123009|OTHER||Median Difference (Final Values)|1.0||||0.3125|TWO_SIDED|90.0|-0.75|5.25||The p-value was assessed based on the Wilcoxon rank sum test.|Wilcoxon rank sum test||The median difference and the 90% confidence interval of the median difference were estimated from Hodges-Lehmann estimate.|||5.2500|-0.7500|0.3125
71810757|NCT01490502|143123058|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
71810758|NCT01490502|143123058|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.57|TWO_SIDED|95.0|0.67|2.05|||Regression, Cox|||||2.05|0.67|0.57
71676571|NCT02111577|142871032|SUPERIORITY||Hazard Ratio (HR)|1.068||||0.439|TWO_SIDED|95.0|0.905|1.262|||Log Rank|||Unstratified||1.262|0.905|0.439
71810759|NCT01490502|143123059|OTHER|||||||0.07|||||||Andersen Gill model for recurrent events|||||||0.07
71810760|NCT01490502|143123060|SUPERIORITY||Rate Ratio|1.8||||0.07|TWO_SIDED|95.0|0.94|3.45|||Negative Binomial Model|||||3.45|0.94|0.07
71810761|NCT01490502|143123061|SUPERIORITY||Rate Ratio|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Negative Binomial Model|||||2.46|0.88|0.14
71810762|NCT01490502|143123062|SUPERIORITY|||||||0.6|||||||Log Rank|||||||0.60
71810763|NCT01490502|143123063|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||The average rate of change in MSFC Z-score over time was analyzed using a linear mixed-effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in the MSFC Z-score between treatment arms.||||0.20
71810764|NCT01490502|143123064|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Rate of change in 2.5% low-contrast acuity was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in low-contrast acuity between treatment arms.||||0.67
71810765|NCT01490502|143123065|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Rate of change in quality of life was analyzed using a linear mixed effects model with unstructured covariance structure and random intercepts. The p-value is a test of whether there is a difference in the rate of change in health-related quality of life between treatment arms.||||0.21
71810766|NCT01490502|143123066|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71810767|NCT01490502|143123067|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71844101|NCT02307682|143202439|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-4.2|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||7.3|-4.2|
71844102|NCT02307682|143202439|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.8|13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||13.4|0.8|
71676572|NCT02111577|142871033|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|1.03||||0.754|TWO_SIDED|95.0|0.857|1.238|||Log Rank|||Stratified||1.238|0.857|0.754
71810768|NCT04186780|143123071|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters were normalized to logarithmic scale."|Mean Difference (Net)|2.5||||0.59|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group in total cholesterol.|||||0.59
71810769|NCT04186780|143123072|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|0.4||||0.8284|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group and intervention group.|||||0.8284
71810770|NCT04186780|143123073|SUPERIORITY||Median Difference (Net)|0.1||||0.0058|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between T0 and T66 in the placebo group compared to the intervention group.|||||0.0058
71810771|NCT04186780|143123074|SUPERIORITY||Median Difference (Net)|0.8||||0.0384|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Reduced difference in TBARS in the placebo group compared to the intervention group at T66.|||||0.0384
71844103|NCT02307682|143202439|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.3|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.5|-4.3|
71676573|NCT02111577|142871033|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.924|TWO_SIDED|95.0|0.844|1.207|||Log Rank|||Unstratified||1.207|0.844|0.924
71676574|NCT02111577|142871034|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.918||||0.732|TWO_SIDED|95.0|0.563|1.497|||Log Rank|||Stratified||1.497|0.563|0.732
71810772|NCT04186780|143123075|SUPERIORITY|"The differences between Shiitake and placebo groups were analyzed by the Chi-square test, Exact of Fisher test and Student's t-test.~Descriptions of all biochemical and oxidative stress parameters were expressed as mean ± standard deviation. To investigate the differences in biochemical parameters between the groups, Analysis of Variance (ANOVA) with repeated measurements was applied. All results of biochemical parameters and oxidative stress were normalized to logarithmic scale."|Mean Difference (Net)|47.0||||0.0352|TWO_SIDED|95.0||||P \< 0.05 was accepted as statistically significant.|ANOVA||Difference between placebo group and intervention group of T66.|||||0.0352
71810773|NCT02066402|143123076|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance. Predefined margin for non-inferiority is -10%.|Difference of responder rate|-4.6||||0.2027|TWO_SIDED|95.0|-11.2|2.2|||Fisher Exact|||||2.2|-11.2|0.2027
71810774|NCT02066402|143123077|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.3|3.8||||||||3.8|-8.3|
71810775|NCT02066402|143123078|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.1|||||TWO_SIDED|95.0|-7.4|3.2||||||||3.2|-7.4|
71676575|NCT02111577|142871034|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.713|TWO_SIDED|95.0|0.561|1.485|||Log Rank|||Unstratified||1.485|0.561|0.713
71810776|NCT02066402|143123079|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||TWO_SIDED|95.0|-8.6|4.1||||||||4.1|-8.6|
71810777|NCT02066402|143123080|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-3.1|||||TWO_SIDED|95.0|-8.4|2.0||||||||2.0|-8.4|
71810778|NCT04493931|143123094|OTHER||Ratio of Geometric LS Mean|0.944|||||TWO_SIDED|90.0|0.753|1.184||||||||1.184|0.753|
71810779|NCT04493931|143123095|OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.75|0.742|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.742|-0.750|
71810780|NCT04493931|143123096|OTHER||Ratio of Geometric LS Mean|1.094|||||TWO_SIDED|90.0|0.959|1.249||||||||1.249|0.959|
71810781|NCT04493931|143123097|OTHER||Ratio of Geometric LS Mean|1.157|||||TWO_SIDED|90.0|1.059|1.265||||||||1.265|1.059|
71810782|NCT04493931|143123098|OTHER||Ratio of Geometric LS Mean|1.158|||||TWO_SIDED|90.0|1.062|1.264||||||||1.264|1.062|
71810783|NCT04493931|143123099|OTHER||Ratio of Geometric LS Mean|0.73|||||TWO_SIDED|90.0|0.635|0.84||||||||0.840|0.635|
71810784|NCT04493931|143123100|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
71810785|NCT04493931|143123101|OTHER||Median Difference (Final Values)|-0.467|||||TWO_SIDED|90.0|-1.0|0.492|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate|||0.492|-1.000|
71810786|NCT04493931|143123102|OTHER||Ratio of Geometric LS Mean|0.476|||||TWO_SIDED|90.0|0.433|0.525||||||||0.525|0.433|
71810787|NCT04493931|143123103|OTHER||Ratio of Geometric LS Mean|0.478|||||TWO_SIDED|90.0|0.435|0.526||||||||0.526|0.435|
71810788|NCT04493931|143123104|OTHER||Ratio of Geometric LS mean|1.533|||||TWO_SIDED|90.0|1.274|1.845||||||||1.845|1.274|
71810789|NCT04493931|143123105|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
71810790|NCT04493931|143123106|OTHER||Median Difference (Final Values)|-0.5|||||TWO_SIDED|90.0|-1.0|-0.233|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||-0.233|-1.000|
71810791|NCT04493931|143123107|OTHER||Ratio of Geometric LS mean|1.217|||||TWO_SIDED|90.0|1.085|1.363||||||||1.363|1.085|
71676576|NCT02111577|142871035|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.891||||0.694|TWO_SIDED|95.0|0.5|1.587|||Log Rank|||Stratified||1.587|0.5|0.694
71676577|NCT02111577|142871035|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.661|TWO_SIDED|95.0|0.496|1.562|||Log Rank|||Unstratified||1.562|0.496|0.661
71676578|NCT02111577|142871036|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.895||||0.111|TWO_SIDED|95.0|0.781|1.027|||Log Rank|||Stratified||1.027|0.781|0.111
71676579|NCT02111577|142871036|SUPERIORITY||Hazard Ratio (HR)|0.913||||0.184|TWO_SIDED|95.0|0.798|1.044|||Log Rank|||Unstratified||1.044|0.798|0.184
71810792|NCT04493931|143123108|OTHER||Ratio of Geometric LS mean|1.121|||||TWO_SIDED|90.0|0.983|1.278||||||||1.278|0.983|
71810793|NCT04493931|143123109|OTHER||Ratio of Geometric LS mean|1.242|||||TWO_SIDED|90.0|1.046|1.475||||||||1.475|1.046|
71810794|NCT04493931|143123110|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|0.000|
71810795|NCT04493931|143123111|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.8|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.800|-0.250|
71810796|NCT04493931|143123112|OTHER||Ratio of Geometric LS mean|1.923|||||TWO_SIDED|90.0|1.622|2.278||||||||2.278|1.622|
71810797|NCT04493931|143123113|OTHER||Ratio of Geometric LS mean|1.902|||||TWO_SIDED|90.0|1.619|2.234||||||||2.234|1.619|
71810798|NCT04493931|143123137|OTHER||Ratio of geometric LS mean|1.051|||||TWO_SIDED|90.0|0.824|1.34||||||||1.340|0.824|
71810799|NCT04493931|143123138|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.250|0.000|
71810800|NCT04493931|143123139|OTHER||Median Difference (Final Values)|0.5|||||TWO_SIDED|90.0|-0.5|1.25|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||1.250|-0.500|
71810801|NCT04493931|143123140|OTHER||Ratio of geometric LS mean|1.094|||||TWO_SIDED|90.0|0.987|1.212||||||||1.212|0.987|
71810802|NCT04493931|143123141|OTHER||Ratio of geometric LS mean|1.095|||||TWO_SIDED|90.0|0.991|1.209||||||||1.209|0.991|
71810803|NCT04493931|143123144|OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.25|0.0|||||The median difference and the 90% CI of the median difference were from Hodges-Lehmann estimate.|||0.000|-0.250|
71810804|NCT04493931|143123147|OTHER||Ratio of geometric LS mean|1.214|||||TWO_SIDED|90.0|1.0|1.473||||||||1.473|1.000|
71810805|NCT04493931|143123148|OTHER||Ratio of geometric LS mean|1.097|||||TWO_SIDED|90.0|0.948|1.27||||||||1.270|0.948|
71810806|NCT04493931|143123149|OTHER||Ratio of geometric LS mean|1.071|||||TWO_SIDED|90.0|0.939|1.221||||||||1.221|0.939|
71810807|NCT04493931|143123150|OTHER||Ratio of geometric LS mean|1.096|||||TWO_SIDED|90.0|0.93|1.292||||||||1.292|0.930|
71810808|NCT04493931|143123164|OTHER||Ratio of geometric LS mean|0.499|||||TWO_SIDED|90.0|0.441|0.565||||||||0.565|0.441|
71810809|NCT04493931|143123165|OTHER||Ratio of geometric LS mean|0.439|||||TWO_SIDED|90.0|0.37|0.521||||||||0.521|0.370|
71810810|NCT04493931|143123166|OTHER||Ratio of geometric LS mean|0.438|||||TWO_SIDED|90.0|0.372|0.516||||||||0.516|0.372|
71810811|NCT04493931|143123167|OTHER||Ratio of geometric LS mean|1.036|||||TWO_SIDED|90.0|0.95|1.129||||||||1.129|0.950|
71810812|NCT04493931|143123191|OTHER||Ratio of Geometric LS mean|1.755|||||TWO_SIDED|90.0|1.304|2.363||||||||2.363|1.304|
71810813|NCT04493931|143123192|OTHER||Ratio of Geometric LS mean|0.833|||||TWO_SIDED|90.0|0.769|0.902||||||||0.902|0.769|
71810814|NCT04493931|143123193|OTHER||Ratio of Geometric LS mean|0.745|||||TWO_SIDED|90.0|0.653|0.85||||||||0.850|0.653|
71810815|NCT04493931|143123194|OTHER||Ratio of Geometric LS mean|0.892|||||TWO_SIDED|90.0|0.782|1.018||||||||1.018|0.782|
71810816|NCT04493931|143123195|OTHER||Ratio of Geometric LS mean|1.157|||||TWO_SIDED|90.0|0.876|1.528||||||||1.528|0.876|
71810817|NCT04493931|143123196|OTHER||Ratio of Geometric LS mean|1.142|||||TWO_SIDED|90.0|1.016|1.283||||||||1.283|1.016|
71895450|NCT02396147|143313439|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|92.99|||||TWO_SIDED|90.0|76.84|112.54|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) \* 100|||112.54|76.84|
71895451|NCT01362322|143313457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted radio|0.96|||||TWO_SIDED|95.0|0.85|1.09|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.||1.09|0.85|
71810818|NCT04493931|143123197|OTHER||Ratio of Geometric LS mean|0.603|||||TWO_SIDED|90.0|0.521|0.699||||||||0.699|0.521|
71676580|NCT02111577|142871037|SUPERIORITY|Stratified by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Hazard Ratio (HR)|0.939||||0.46|TWO_SIDED|95.0|0.795|1.11|||Log Rank|||Stratified||1.11|0.795|0.46
71896334|NCT03114969|143314795|SUPERIORITY||Odds Ratio (OR)|11.907||||0.079|TWO_SIDED|95.0|0.753|188.208||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||188.208|0.753|0.079
71676581|NCT02111577|142871037|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.534|TWO_SIDED|95.0|0.807|1.118|||Log Rank|||Unstratified||1.118|0.807|0.534
71810819|NCT04493931|143123198|OTHER||Ratio of Geometric LS mean|0.526|||||TWO_SIDED|90.0|0.448|0.618||||||||0.618|0.448|
71810820|NCT01197508|143123233|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.84||1|TWO_SIDED|95.0|-0.53|2.79||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.79|-0.53|1.000
71810821|NCT01197508|143123233|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.85||1|TWO_SIDED|95.0|-1.22|2.13|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.13|-1.22|1.000
71676582|NCT02111577|142871038|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.845||||0.485|TWO_SIDED|95.0|0.528|1.355|||Log binomial model|||Stratified||1.355|0.528|0.485
71676583|NCT02111577|142871039|SUPERIORITY|Adjusted by region (US vs other), prior abiraterone (Yes vs No), prior enzalutamide (Yes vs No) and ECOG score (0, 1 vs 2)|Risk Ratio (RR)|0.92||||0.768|TWO_SIDED|95.0|0.529|1.601|||Log binomial model|||Stratified||1.601|0.529|0.768
71813935|NCT02799472|143129767|OTHER||Mean Difference (Net)|-20744.2||||0.026|TWO_SIDED|95.0|-38771.8|-2716.5|||Repeated measures analysis|||CD14lo+CD16br+, 12-Week FU||-2716.5|-38771.8|0.026
71896335|NCT03114969|143314795|SUPERIORITY||Odds Ratio (OR)|15.06||||0.063|TWO_SIDED|95.0|0.866|262.042||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||262.042|0.866|0.063
71896336|NCT03114969|143314796|SUPERIORITY||Odds Ratio (OR)|2.67||||0.239|TWO_SIDED|95.0|0.521|13.69||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||13.690|0.521|0.239
71896337|NCT03114969|143314796|SUPERIORITY||Odds Ratio (OR)|2.929||||0.2|TWO_SIDED|95.0|0.567|15.125||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.125|0.567|0.200
71896338|NCT03114969|143314796|SUPERIORITY||Odds Ratio (OR)|4.269||||0.078|TWO_SIDED|95.0|0.848|21.489||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||21.489|0.848|0.078
71896339|NCT03114969|143314796|SUPERIORITY||Odds Ratio (OR)|5.132||||0.046|TWO_SIDED|95.0|1.031|25.55||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||25.550|1.031|0.046
71896340|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|3.483||||0.02|TWO_SIDED|95.0|1.218|9.961||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||9.961|1.218|0.020
71810822|NCT01197508|143123233|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.88||1|TWO_SIDED|95.0|-1.21|2.22|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.22|-1.21|1.000
71676584|NCT03521115|142871051|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.01|TWO_SIDED||||||Regression, Logistic|b=-.91, controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
71810823|NCT01197508|143123234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.17||0.144|TWO_SIDED|95.0|0.45|1.12|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.12|0.45|0.144
71810824|NCT01197508|143123234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.17||0.203|TWO_SIDED|95.0|0.47|1.17|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.17|0.47|0.203
71810825|NCT01197508|143123234|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.32|0.82|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.82|0.32|0.005
71810826|NCT01197508|143123235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.636|TWO_SIDED|95.0|0.54|1.45|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.45|0.54|0.636
71810827|NCT01197508|143123235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73|STANDARD_ERROR_OF_MEAN|0.19||0.215|TWO_SIDED|95.0|0.44|1.2|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.20|0.44|0.215
71810828|NCT01197508|143123235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|STANDARD_ERROR_OF_MEAN|0.15||0.034|TWO_SIDED|95.0|0.35|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.35|0.034
71810829|NCT01197508|143123236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.37||0.711|TWO_SIDED|95.0|0.36|1.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.99|0.36|0.711
71810830|NCT01197508|143123236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79|STANDARD_ERROR_OF_MEAN|0.34||0.594|TWO_SIDED|95.0|0.34|1.85|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.85|0.34|0.594
71810831|NCT01197508|143123236|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15|STANDARD_ERROR_OF_MEAN|0.49||0.749|TWO_SIDED|95.0|0.5|2.65|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.65|0.50|0.749
71810832|NCT01197508|143123237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.16||0.037|TWO_SIDED|95.0|0.28|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.96|0.28|0.037
71810833|NCT01197508|143123237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.21||0.222|TWO_SIDED|95.0|0.38|1.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.25|0.38|0.222
71810834|NCT01197508|143123237|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52|STANDARD_ERROR_OF_MEAN|0.17||0.042|TWO_SIDED|95.0|0.28|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||0.98|0.28|0.042
71813936|NCT02799472|143129768|OTHER||Mean Difference (Net)|178.2||||0.564|TWO_SIDED|95.0|-448.3|804.6|||Repeated measures analysis|||Week 1||804.6|-448.3|0.564
71813937|NCT02799472|143129768|OTHER||Mean Difference (Net)|540.4||||0.216|TWO_SIDED|95.0|-335.7|1416.5|||Repeated measures analysis|||Week 4||1416.5|-335.7|0.216
71813938|NCT02799472|143129768|OTHER||Mean Difference (Net)|-252.6||||0.629|TWO_SIDED|95.0|-1326.0|820.8|||Repeated measures analysis|||Week 12||820.8|-1326.0|0.629
71813939|NCT02799472|143129768|OTHER||Mean Difference (Net)|41.6||||0.932|TWO_SIDED|95.0|-962.2|1045.5|||Repeated measures analysis|||12-Week FU||1045.5|-962.2|0.932
71813940|NCT02799472|143129776|OTHER||Median Difference (Net)|-0.13||||0.547|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \<0||2.23|-2.32|0.547
71813941|NCT02799472|143129776|OTHER||Median Difference (Net)|-2.18||||0.948|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \<0||0.51|-4.77|0.948
71813942|NCT02799472|143129776|OTHER||Median Difference (Net)|-2.28||||0.949|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \<0||0.45|-5.02|0.949
71813943|NCT02799472|143129776|OTHER||Median Difference (Net)|-0.13||||0.453|TWO_SIDED|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference \>0||2.23|-2.32|0.453
71676585|NCT03521115|142871051|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.1|TWO_SIDED||||||Regression, Logistic||Controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
71676586|NCT03521115|142871051|SUPERIORITY||Chi-Square|5.129||||0.077|TWO_SIDED||||||Chi-squared|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||.077
71676587|NCT03521115|142871052|SUPERIORITY||b|-0.47|||<|0.001|TWO_SIDED||||||Regression, Linear|Controled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.001
71676588|NCT03521115|142871052|SUPERIORITY||b|-0.97|||<|0.01|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
71676589|NCT03521115|142871052|SUPERIORITY||F|0.85|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
71810835|NCT01197508|143123238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.41||0.913|TWO_SIDED|95.0|0.48|2.27|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.27|0.48|0.913
71810836|NCT01197508|143123238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.37||0.841|TWO_SIDED|95.0|0.42|2.01|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.01|0.42|0.841
71810837|NCT01197508|143123238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|STANDARD_ERROR_OF_MEAN|0.26||0.239|TWO_SIDED|95.0|0.26|1.39|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.39|0.26|0.239
71810838|NCT01197508|143123239|SUPERIORITY_OR_OTHER||LS mean|1.1|STANDARD_ERROR_OF_MEAN|0.705||0.12|TWO_SIDED|95.0|-0.288|2.481|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.481|-0.288|0.120
71810839|NCT01197508|143123239|SUPERIORITY_OR_OTHER||LS mean|0.95|STANDARD_ERROR_OF_MEAN|0.715||0.184|TWO_SIDED|95.0|-0.452|2.354|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.354|-0.452|0.184
71810840|NCT01197508|143123239|SUPERIORITY_OR_OTHER||LS mean|2.09|STANDARD_ERROR_OF_MEAN|0.711||0.003|TWO_SIDED|95.0|0.692|3.484|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.484|0.692|0.003
71810841|NCT01197508|143123240|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.131||95.0|-0.05|0.42|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.42|-0.05|0.131
71810842|NCT01197508|143123240|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.551|TWO_SIDED|95.0|-0.17|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.31|-0.17|0.551
71844104|NCT02307682|143202439|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.4|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.4|-3.4|
71844105|NCT02307682|143202439|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.0|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.2|-5.0|
71844106|NCT02307682|143202439|OTHER||Difference in proportions|7.9|||||TWO_SIDED|95.0|1.5|14.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||14.4|1.5|
71844107|NCT02307682|143202439|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.0|-5.4|
71895452|NCT01362322|143313457|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.1|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.||1.1|0.86|
71810843|NCT01197508|143123240|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.645|TWO_SIDED|95.0|-0.19|0.3|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.30|-0.19|0.645
71810844|NCT01197508|143123241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.046|TWO_SIDED|95.0|0.38|0.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.99|0.38|0.046
71810845|NCT01197508|143123241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|STANDARD_ERROR_OF_MEAN|0.15||0.051|TWO_SIDED|95.0|0.38|1.0|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.00|0.38|0.051
71810846|NCT01197508|143123241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.15||0.04|TWO_SIDED|95.0|0.37|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||0.98|0.37|0.040
71810847|NCT01197508|143123242|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.66||0.273|TWO_SIDED|95.0|-0.58|2.03|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.03|-0.58|0.273
71810848|NCT01197508|143123242|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.315|TWO_SIDED|95.0|-0.65|2.0|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.00|-0.65|0.315
71813944|NCT02799472|143129776|OTHER||Median Difference (Net)|-2.18||||0.052|TWO_SIDED|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference \>0||0.51|-4.77|0.052
71813945|NCT02799472|143129776|OTHER||Median Difference (Net)|-2.28||||0.051|TWO_SIDED|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference \>0||0.45|-5.02|0.051
71813946|NCT02799472|143129777|OTHER||Mean Difference (Net)|0.0||||0.94|TWO_SIDED|95.0|-0.2|0.3|||Repeated measures analysis|||Week 4||0.3|-0.2|0.940
71813947|NCT02799472|143129777|OTHER||Mean Difference (Net)|-0.8||||0.521|TWO_SIDED|95.0|-3.2|1.6|||Repeated measures analysis|||Week 12||1.6|-3.2|0.521
71813948|NCT02799472|143129777|OTHER||Mean Difference (Net)|-1.3||||0.396|TWO_SIDED|95.0|-4.4|1.8|||Repeated measures analysis|||12-Week FU||1.8|-4.4|0.396
71813949|NCT02799472|143129778|OTHER||Mean Difference (Net)|0.0||||0.945|TWO_SIDED|95.0|-1.1|1.2|||Repeated measures analysis|||Week 4||1.2|-1.1|0.945
71813950|NCT02799472|143129778|OTHER||Mean Difference (Net)|-0.4||||0.475|TWO_SIDED|95.0|-1.5|0.7|||Repeated measures analysis|||Week 12||0.7|-1.5|0.475
71813951|NCT02799472|143129778|OTHER||Mean Difference (Net)|-0.9||||0.086|TWO_SIDED|95.0|-2.0|0.1|||Repeated measures analysis|||12-Week FU||0.1|-2.0|0.086
71813952|NCT02799472|143129779|OTHER||Mean Difference (Net)|211.4||||0.874|TWO_SIDED|95.0|-2589.2|3012.0|||Repeated measures analysis|||Week 4||3012.0|-2589.2|0.874
71813953|NCT02799472|143129779|OTHER||Mean Difference (Net)|-504.8||||0.749|TWO_SIDED|95.0|-3730.4|2720.9|||Repeated measures analysis|||Week 12||2720.9|-3730.4|0.749
71813954|NCT02799472|143129779|OTHER||Mean Difference (Net)|-1536.0||||0.352|TWO_SIDED|95.0|-4884.2|1812.1|||Repeated measures analysis|||12-Week FU||1812.1|-4884.2|0.352
71813955|NCT02799472|143129780|OTHER||Mean Difference (Net)|0.0128||||0.291|TWO_SIDED|95.0|-0.0123|0.038|||Repeated measures analysis|||Week 4||0.0380|-0.0123|0.291
71813956|NCT02799472|143129780|OTHER||Mean Difference (Net)|0.0036||||0.375|TWO_SIDED|95.0|-0.0046|0.0118|||Repeated measures analysis|||Week 12||0.0118|-0.0046|0.375
71813957|NCT02799472|143129780|OTHER||Mean Difference (Net)|0.001||||0.588|TWO_SIDED|95.0|-0.0028|0.0049|||Repeated measures analysis|||12-Week FU||0.0049|-0.0028|0.588
71813958|NCT02799472|143129781|OTHER||Mean Difference (Net)|-0.0002||||0.915|TWO_SIDED|95.0|-0.0033|0.0029|||Repeated measures analysis|||Week 4||0.0029|-0.0033|0.915
71813959|NCT02799472|143129781|OTHER||Mean Difference (Net)|-0.0004||||0.771|TWO_SIDED|95.0|-0.0028|0.0021|||Repeated measures analysis|||Week 12||0.0021|-0.0028|0.771
71813960|NCT02799472|143129781|OTHER||Mean Difference (Net)|0.0005||||0.85|TWO_SIDED|95.0|-0.0048|0.0058|||Repeated measures analysis|||12-Week FU||0.0058|-0.0048|0.850
71813961|NCT00674570|143129782|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.06|=|0.66|TWO_SIDED|95.0|-0.15|0.1|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.10|-.15|=.66
71813962|NCT00674570|143129782|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.41|TWO_SIDED|95.0|-0.17|0.07|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)||.07|-.17|=.41
71895453|NCT01362322|143313458|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.82|1.04|||ANCOVA|||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.||1.04|0.82|
71810849|NCT01197508|143123242|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.67||0.078|TWO_SIDED|95.0|-0.13|2.51|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.||2.51|-0.13|0.078
71810850|NCT01197508|143123243|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.47||0.59|TWO_SIDED|95.0|-0.68|1.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.19|-0.68|0.590
71810851|NCT01197508|143123243|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.48||0.679|TWO_SIDED|95.0|-0.74|1.14|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.14|-0.74|0.679
71810852|NCT01197508|143123243|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.53|-0.35|0.215
71810853|NCT01197508|143123244|SUPERIORITY_OR_OTHER||LS mean|1.2|STANDARD_ERROR_OF_MEAN|0.61||0.052|TWO_SIDED|95.0|-0.01|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.01|0.052
71810854|NCT01197508|143123244|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.874|TWO_SIDED|95.0|-1.11|1.3|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.30|-1.11|0.874
71810855|NCT01197508|143123244|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.099|TWO_SIDED|95.0|-0.19|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.19|0.099
71810856|NCT01197508|143123245|SUPERIORITY_OR_OTHER||LS mean|0.6|STANDARD_ERROR_OF_MEAN|0.69||0.394|TWO_SIDED|95.0|-0.77|1.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.95|-0.77|0.394
71844108|NCT02307682|143202439|OTHER||Difference in proportions|8.1|||||TWO_SIDED|95.0|2.1|14.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||14.5|2.1|
71844109|NCT02307682|143202439|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-4.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||8.1|-4.4|
71844110|NCT02307682|143202439|OTHER||Difference in proportions|8.3|||||TWO_SIDED|95.0|2.0|15.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||15.1|2.0|
71844111|NCT02307682|143202439|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.1|-5.2|
71895454|NCT01362322|143313458|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.||1.03|0.83|
71810857|NCT01197508|143123245|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.712|TWO_SIDED|95.0|-1.11|1.63|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.63|-1.11|0.712
71844112|NCT02307682|143202439|OTHER||Difference in proportions|7.6|||||TWO_SIDED|95.0|0.7|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.8|0.7|
71676590|NCT03521115|142871053|SUPERIORITY||b|-0.22|||<|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.10
71895455|NCT01362322|143313458|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios \[Boostrix-Prev Group over Boostrix-New Group\] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted ratio|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.||1.13|0.85|
71676591|NCT03521115|142871053|SUPERIORITY||b|-0.24|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71676592|NCT03521115|142871053|SUPERIORITY||F|0.43|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
71676593|NCT03521115|142871054|SUPERIORITY||b|-0.16|||<|0.1|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.10
71676594|NCT03521115|142871054|SUPERIORITY||b|-0.26|||<|0.05|TWO_SIDED||||||Regression, Linear|Controlled for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.||12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71676595|NCT03521115|142871054|SUPERIORITY||F|1.55|||>|0.1|TWO_SIDED||||||ANOVA|||18 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. All controls were assigned 0 dosage.||||>0.10
71676596|NCT03521115|142871055|SUPERIORITY||b|-0.35|||<|0.05|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|6 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71810858|NCT01197508|143123245|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.71||0.167|TWO_SIDED|95.0|-0.41|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.38|-0.41|0.167
71810859|NCT01197508|143123246|SUPERIORITY_OR_OTHER||LS mean|1.5|STANDARD_ERROR_OF_MEAN|0.75||0.046|TWO_SIDED|95.0|0.02|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|0.02|0.046
71810860|NCT01197508|143123246|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.681|TWO_SIDED|95.0|-1.17|1.79|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.79|-1.17|0.681
71810861|NCT01197508|143123246|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.77||0.087|TWO_SIDED|95.0|-0.19|2.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.84|-0.19|0.087
71810862|NCT01197508|143123247|SUPERIORITY_OR_OTHER||LS mean|0.98|STANDARD_ERROR_OF_MEAN|0.736||1|TWO_SIDED|95.0|-0.464|2.427||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.427|-0.464|1.000
71895456|NCT01466751|143313470|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|8.687||||0.004|TWO_SIDED|||||A-priori threshold for statistical significance: p \< 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.|Mixed Models Analysis|Numerator degrees of freedom=1, Denominator degrees of freedom = 168||A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.||||0.004
71895457|NCT01466751|143313471|SUPERIORITY_OR_OTHER||Type III Tests of Fixed Effects|2.032||||0.156|TWO_SIDED|||||No adjustment for multiple comparisons. The a priori threshold was: p \< 0.05.|Mixed Models Analysis|Numerator degrees of freedom: 1, Denominator degrees of freedom: 168||A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).||||0.156
71895458|NCT02413398|143313472|SUPERIORITY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.53|-0.15|||Mixed Models Analysis|||Difference in adjusted mean change from baseline (MMRM model)||-0.15|-0.53|<0.001
71895459|NCT02413398|143313473|SUPERIORITY||Mean Difference (Final Values)|-1.43|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.15|-0.69|||Mixed Models Analysis|||Difference in adjusted mean percent change from baseline (MMRM)||-0.69|-2.15|<0.001
71895460|NCT02413398|143313474|SUPERIORITY||Mean Difference (Final Values)|-16.59|STANDARD_ERROR_OF_MEAN|5.15||0.001|TWO_SIDED|95.0|-26.73|-6.45|||Mixed Models Analysis|||Difference in adjusted mean change from baseline versus placebo (MMRM)||-6.45|-26.73|0.001
71895461|NCT02413398|143313475|SUPERIORITY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.6|<|0.05|TWO_SIDED|95.0|-6.3|0.0|||Mixed Models Analysis|||Difference in adjusted mean change from baseline vs. placebo (MMRM)||0.0|-6.3|<0.050
71895462|NCT02874794|143313498|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.7827|TWO_SIDED|95.0|-17.6|13.2|||ANCOVA|||||13.2|-17.6|0.7827
71810863|NCT01197508|143123247|SUPERIORITY_OR_OTHER||LS mean|0.72|STANDARD_ERROR_OF_MEAN|0.746||1|TWO_SIDED|95.0|-0.74|2.188||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.188|-0.740|1.000
71895463|NCT02874794|143313501|SUPERIORITY||Ratio of Geometric Means|0.6667|||<|0.0001|TWO_SIDED|95.0|0.5858|0.7589|||ANCOVA|||||0.7589|0.5858|<.0001
71895464|NCT02874794|143313502|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5792|TWO_SIDED|95.0|-0.58|0.33|||ANCOVA|||||0.33|-0.58|0.5792
71895465|NCT02874794|143313503|SUPERIORITY||Mean Difference (Final Values)|-2.8|||<|0.0001|TWO_SIDED|95.0|-4.02|-1.59|||ANCOVA|||||-1.59|-4.02|<.0001
71676597|NCT03521115|142871055|SUPERIORITY||b|-0.02|||>|0.1|TWO_SIDED||||||Regression, Linear||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|12 month follow-up. Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing only the communication, and 2 for completing the alcohol component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71810864|NCT01197508|143123247|SUPERIORITY_OR_OTHER||LS mean|0.85|STANDARD_ERROR_OF_MEAN|0.762||1|TWO_SIDED|95.0|-0.649|2.346||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.346|-0.649|1.000
71810865|NCT01197508|143123248|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.914|TWO_SIDED|95.0|-0.54|0.61|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.61|-0.54|0.914
71810866|NCT01197508|143123248|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.446|TWO_SIDED|95.0|-0.36|0.81|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.81|-0.36|0.446
71895466|NCT02874794|143313504|SUPERIORITY||Median Difference (Final Values)|-0.03||||0.8617|TWO_SIDED|95.0|-0.33|0.27|||ANCOVA|||||0.27|-0.33|0.8617
71895467|NCT02874794|143313505|SUPERIORITY||Median Difference (Final Values)|-1.75||||0.0007|TWO_SIDED|95.0|-2.76|-0.75|||ANCOVA|||vs Enalapril||-0.75|-2.76|0.0007
71895468|NCT02874794|143313506|SUPERIORITY||Median Difference (Final Values)|0.63||||0.2354|TWO_SIDED|95.0|-0.41|1.68|||ANCOVA|||||1.68|-0.41|0.2354
71895469|NCT02874794|143313507|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8215|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||||0.04|-0.05|0.8215
71895470|NCT02874794|143313508|SUPERIORITY||Median Difference (Final Values)|-1.58||||0.0452|TWO_SIDED|95.0|-3.13|-0.03|||ANCOVA|||||-0.03|-3.13|0.0452
71895471|NCT02874794|143313509|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0242|TWO_SIDED|95.0|-3.68|-0.26|||ANCOVA|||||-0.26|-3.68|0.0242
71895472|NCT01062399|143313528|OTHER||||||||||||||||||A dose level for RAD001 will be considered acceptable if no patient of the first 3patients or no more than 2 patients of the first 6 patients experience a DLT. If the current level is considered acceptable, then dose escalation will occur and the protocol will be reopened. Otherwise, the preceding acceptable dose level will be declared the MTD.|||
71676598|NCT03521115|142871056|SUPERIORITY||b|0.299|||<|0.01|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.01
71676599|NCT03521115|142871057|SUPERIORITY||b|0.268|||<|0.03|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<.03
71676600|NCT03521115|142871058|SUPERIORITY||b|0.075|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71676601|NCT03521115|142871059|SUPERIORITY||b|0.051|||>|0.1|TWO_SIDED||||||generalized estimating equations||controlling for condition (experimental vs. control) , IMR, baseline measure of outcome variable, teen gender, age, \& race.|Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71810867|NCT01197508|143123248|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.31||0.656|TWO_SIDED|95.0|-0.47|0.75|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.75|-0.47|0.656
71810868|NCT01197508|143123249|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.248|TWO_SIDED|95.0|-0.21|0.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.82|-0.21|0.248
71810869|NCT01197508|143123249|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.498|TWO_SIDED|95.0|-0.34|0.7|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.70|-0.34|0.498
71810870|NCT01197508|143123249|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.441|TWO_SIDED|95.0|-0.32|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.74|-0.32|0.441
71810871|NCT01197508|143123250|SUPERIORITY_OR_OTHER||LS mean|0.4|STANDARD_ERROR_OF_MEAN|0.26||0.174|TWO_SIDED|95.0|-0.16|0.87|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.87|-0.16|0.174
71810872|NCT01197508|143123250|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.402|TWO_SIDED|95.0|-0.3|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.74|-0.30|0.402
71810873|NCT01197508|143123250|SUPERIORITY_OR_OTHER||LS mean|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.197|TWO_SIDED|95.0|-0.18|0.88|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.88|-0.18|0.197
71810874|NCT01197508|143123251|SUPERIORITY_OR_OTHER||LS mean|-1.47|STANDARD_ERROR_OF_MEAN|1.643||0.371|TWO_SIDED|95.0|-4.697|1.756|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.756|-4.697|0.371
71844113|NCT02307682|143202439|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-6.8|
71810875|NCT01197508|143123251|SUPERIORITY_OR_OTHER||LS mean|-1.32|STANDARD_ERROR_OF_MEAN|1.672||0.432|TWO_SIDED|95.0|-4.597|1.967|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.967|-4.597|0.432
71810876|NCT01197508|143123251|SUPERIORITY_OR_OTHER||LS mean|-2.71|STANDARD_ERROR_OF_MEAN|1.672||0.105|TWO_SIDED|95.0|-5.992|0.573|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.573|-5.992|0.105
71844114|NCT02307682|143202439|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|2.2|15.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||15.0|2.2|
71810877|NCT01197508|143123252|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.312|TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.09|-0.29|0.312
71810878|NCT01197508|143123252|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.885|TWO_SIDED|95.0|-0.18|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.21|-0.18|0.885
71810879|NCT01197508|143123252|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.067|TWO_SIDED|95.0|-0.37|0.01|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.01|-0.37|0.067
71810880|NCT01197508|143123253|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.152|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.05|-0.33|0.152
71810881|NCT01197508|143123253|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.078|TWO_SIDED|95.0|-0.37|0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.02|-0.37|0.078
71810882|NCT01197508|143123253|SUPERIORITY_OR_OTHER||LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.41|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||-0.02|-0.41|0.033
71810883|NCT01197508|143123254|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0181||0.543|TWO_SIDED|95.0|-0.0465|0.0245||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0245|-0.0465|0.543
71810884|NCT01197508|143123254|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.0183||0.998|TWO_SIDED|95.0|-0.036|0.0361||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0361|-0.0360|0.998
71810885|NCT01197508|143123254|SUPERIORITY_OR_OTHER||LS mean|-0.006|STANDARD_ERROR_OF_MEAN|0.0188||0.743|TWO_SIDED|95.0|-0.0432|0.0308||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0308|-0.0432|0.743
71810886|NCT01197508|143123254|SUPERIORITY_OR_OTHER||LS mean|-2.3|STANDARD_ERROR_OF_MEAN|1.95||0.244|TWO_SIDED|95.0|-6.1|1.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.56|-6.10|0.244
71810887|NCT01197508|143123254|SUPERIORITY_OR_OTHER||LS mean|-1.7|STANDARD_ERROR_OF_MEAN|1.98||0.389|TWO_SIDED|95.0|-5.59|2.18||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.18|-5.59|0.389
71810888|NCT01197508|143123254|SUPERIORITY_OR_OTHER||LS mean|-2.8|STANDARD_ERROR_OF_MEAN|2.02||0.165|TWO_SIDED|95.0|-6.79|1.16||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.16|-6.79|0.165
71810889|NCT02182973|143123262|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71810890|NCT02182973|143123263|SUPERIORITY|||||||0.875|||||||t-test, 2 sided|||||||0.875
71895473|NCT01062399|143313529|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.79|TWO_SIDED|95.0|0.82|1.6|||Log Rank||Reference arm = RT + TMZ|Assuming exponential distribution with median PFS (mPFS) time for control of 6.7 mos. for the control arm, tt was hypothesized that there would be a 43% improvement in mPFS time, corresponding to a mPFS time of 9.6. This is equivalent to a hazard ratio of 0.7 for the experimental arm vs. control arm. With a 1-sided significance level = 0.15 and 85% power, a total of 134 PFS events out of 180 eligible patients were required to detect the projected effect size.||1.60|0.82|0.79
71895474|NCT01062399|143313530|SUPERIORITY||Hazard Ratio (HR)|1.67||||0.008|TWO_SIDED|95.0|1.14|2.45|||Log Rank|2-sided significance level = 0.05|Reference level = RT + TMZ|||2.45|1.14|0.008
71810891|NCT02182973|143123264|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||||||0.025
71810892|NCT01123382|143123265|SUPERIORITY_OR_OTHER|||||||0.04||||||Group X time interaction|Mixed Models Analysis|we included a random intercept for each individual participant. We used a first-order antedependent covariance structure.||To detect a minimum clinically important difference of 2 points2 on the BPI-SF3 with an anticipated standard deviation for each mean of 2.5, estimated from a prior study, with an alpha level of 0.05 and a power of 80%, for five waves of data, a sample size of 10 participants per group was necessary. With anticipated dropouts, a sample size of at least 12 participants per group was required.||||0.04
71810893|NCT01123382|143123266|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED|||||group x time interaction 0.059|Mixed Models Analysis|||||||0.059
71810894|NCT01123382|143123267|SUPERIORITY_OR_OTHER|||||||0.543||||||group x time interaction 0.543|Mixed Models Analysis|||||||0.543
71810895|NCT01123382|143123268|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||group x time interaction 0.33|Mixed Models Analysis|||||||0.33
71810896|NCT01123382|143123269|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||group x time 0.61|Mixed Models Analysis|||||||0.61
71810897|NCT01123382|143123270|SUPERIORITY_OR_OTHER|||||||0.398||||||group x time interaction 0.398|Mixed Models Analysis|||||||0.398
71810898|NCT01123382|143123271|SUPERIORITY_OR_OTHER|||||||0.46||||||group x time interaction 0.46|Mixed Models Analysis|||||||0.46
71810899|NCT01123382|143123272|SUPERIORITY_OR_OTHER|||||||0.59||||||group x time interaction 0.59|Mixed Models Analysis|||||||0.59
71810900|NCT01123382|143123273|SUPERIORITY_OR_OTHER|||||||0.69||||||group x time interaction 0.69|Mixed Models Analysis|||||||0.69
71810901|NCT05120115|143123277|EQUIVALENCE|Examined differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|ANOVA|||||||0.05
71810902|NCT05120115|143123278|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
71810903|NCT05120115|143123279|EQUIVALENCE|Differences between conditions||||||0.05||||||Used Tukey Honestly Significant Difference post-hoc test|Mixed Models Analysis|||||||0.05
71810904|NCT01058304|143123464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.67||||0.1024|TWO_SIDED|95.0|-5.87|0.538|||Mixed Models Analysis|||"The analysis compares study Arm 1 and Arm 2 at 24-week follow-up, with 12-week data also included in the response trajectory.~The hypothesis being tested is that group-based PT (Arm 1) will result in a significantly greater improvement WOMAC scores compared to individual PT (Arm 2)"||0.538|-5.87|0.1024
71810905|NCT01058304|143123464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.444|TWO_SIDED|95.0|-4.64|2.04|||Mixed Models Analysis|||The hypothesis being tested is that the group-based PT program (Arm 1) will result in greater improvements in WOMAC scores at 24-week follow-up (12 weeks after the end of the group program) when compared to usual PT care (Arm 2).||2.04|-4.64|0.444
71810906|NCT01058304|143123465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113||||0.527|TWO_SIDED|95.0|-0.463|0.238|||Mixed Models Analysis|||The analysis compares Arms 1 and 2 at 12-week follow-up. The hypothesis being tested is that the group-based PT program (Arm 1) will result in a significantly greater improvement in SPPB scores compared with the individual PT program (Arm 2).||0.238|-0.463|0.527
71810907|NCT02755597|143123467|SUPERIORITY||Hazard Ratio (HR)|0.656|||=|0.012|TWO_SIDED|95.0|0.471|0.913|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.913|0.471|=0.012
71810908|NCT02755597|143123468|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
71810909|NCT02755597|143123470|SUPERIORITY||Hazard Ratio (HR)|0.508|||<|0.001|TWO_SIDED|95.0|0.343|0.753|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.753|0.343|<0.001
71810910|NCT02755597|143123475|SUPERIORITY||Hazard Ratio (HR)|1.191|||=|0.385|TWO_SIDED|95.0|0.802|1.77|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||1.770|0.802|=0.385
71810911|NCT02755597|143123476|SUPERIORITY||Hazard Ratio (HR)|0.571|||=|0.001|TWO_SIDED|95.0|0.405|0.805|||Log Rank||Hazard ratio was estimated by Cox proportional hazards model|Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||0.805|0.405|=0.001
71810912|NCT02755597|143123477|SUPERIORITY||||||=|0.019|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||=0.019
71810913|NCT02755597|143123478|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)||||<0.001
71810914|NCT01069354|143123479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.41|||<|0.0001|TWO_SIDED|||||Paired t-test|t-test, 2 sided|||||||<0.0001
71810915|NCT01069354|143123480|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Binomial proportion, two-sided Fisher's exact test|Fisher Exact|||91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0||||<0.0001
71810916|NCT01069354|143123481|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
71810917|NCT01069354|143123482|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
71810918|NCT01069354|143123483|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
71810919|NCT01069354|143123484|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Paired t-test|t-test, 2 sided|||||||<0.0001
71810920|NCT01069354|143123485|SUPERIORITY_OR_OTHER|||||||0.5663||||||Paired t-test|t-test, 2 sided|||||||0.5663
71810921|NCT01069354|143123486|SUPERIORITY_OR_OTHER|||||||0.3197||||||Paired t-test|t-test, 2 sided|||||||0.3197
71810922|NCT02152982|143123512|SUPERIORITY|||||||0.1462|||||||Log Rank|||||||0.1462
71810923|NCT02152982|143123513|SUPERIORITY||Cox Proportional Hazard|1.02||||0.9101|TWO_SIDED|95.0|0.7|1.5|||Type 3 likelihood-ratio p-value|||||1.50|0.70|0.9101
71810924|NCT02152982|143123514|SUPERIORITY||Cox Proportional Hazard|1.05||||0.3059|TWO_SIDED|95.0|0.86|1.29|||Log Rank|||||1.29|0.86|0.3059
71810925|NCT02152982|143123515|SUPERIORITY|||||||0.6827|||||||Chi-squared|||||||0.6827
71810926|NCT02152982|143123516|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71810927|NCT02684006|143123519|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.0001|TWO_SIDED|95.0|0.475|0.79||2-sided p-value|Log Rank|||||0.790|0.475|0.0001
71810928|NCT02684006|143123520|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1509|TWO_SIDED|95.0|0.701|1.057||2-sided p-value|Log Rank|||||1.057|0.701|0.1509
71810929|NCT02684006|143123521|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0002|TWO_SIDED|95.0|0.563|0.84||2-sided p-value|Log Rank|||||0.840|0.563|0.0002
71810930|NCT02684006|143123522|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1338|TWO_SIDED|95.0|0.749|1.039||2-sided p-value|Log Rank|||||1.039|0.749|0.1338
71810931|NCT02684006|143123531|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.565|0.768||2-sided p-value|Log Rank|||||0.768|0.565|<.0001
71810932|NCT02684006|143123532|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.551|0.754||||||||0.754|0.551|
71810933|NCT00762450|143123553|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|paired t-tests||The null hypothesis states that there is no difference between groups.||||0.05
71810934|NCT03905330|143123554|SUPERIORITY||Least-Square mean|-1.089|STANDARD_ERROR_OF_MEAN|0.3691|=|0.0063|TWO_SIDED|95.0|-1.845|-0.334|||Mixed Models Analysis|||The difference between maralixibat and placebo treatment groups in the mean change in the average ItchRO(Obs) severity score between baseline and Weeks 15-26||-0.334|-1.845|= 0.0063
71810935|NCT03905330|143123555|SUPERIORITY||Least-Square mean|-186.723|STANDARD_ERROR_OF_MEAN|51.9501|=|0.0013|TWO_SIDED|95.0|-293.454|-79.992|||Mixed Models Analysis|||||-79.992|-293.454|= 0.0013
71810936|NCT03905330|143123556|SUPERIORITY||Least-Square mean|-1.2|STANDARD_ERROR_OF_MEAN|0.263|<|0.0001|TWO_SIDED|95.0|-1.727|-0.674|||Mixed Models Analysis|||||-0.674|-1.727|< 0.0001
71810937|NCT03905330|143123557|SUPERIORITY||Least-Square mean|-160.403|STANDARD_ERROR_OF_MEAN|30.1827|<|0.0001|TWO_SIDED|95.0|-220.836|-99.97|||Mixed Models Analysis|||||-99.970|-220.836|< 0.0001
71810938|NCT03905330|143123558|OTHER||||||=|0.0736|||||||Bernard's exact test|||||||= 0.0736
71810939|NCT03905330|143123559|SUPERIORITY||||||=|0.041|||||||Bernard's exact test|||||||= 0.0410
71844115|NCT02307682|143202439|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.9|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||9.2|-3.9|
71810940|NCT03905330|143123560|SUPERIORITY||||||=|0.0023|||||||Bernard's exact test|||||||= 0.0023
71810941|NCT03905330|143123561|SUPERIORITY||||||=|0.0004|||||||Bernard's exact test|||||||= 0.0004
71810942|NCT05417620|143123562|OTHER||Incidence rate ratio|1.21||||0.707|TWO_SIDED|95.0|0.44|3.31||Threshold for significance: 0.05.|Regression, Poisson|||"This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report rate = average counts of PrEP initiations per number of study months."||3.31|0.44|0.707
71810943|NCT02413580|143123573|OTHER|The hypothesis test is to test the null hypothesis: H0: μd = 0 versus alternative hypothesis Ha: μd ≠ 0 where μd is the mean change from Baseline to Day 14. The Shapiro-Wilk test is used to test the normality. If the assumptions for parametric test are met, a paired t-test (comparison between the pre- and post-treatment) is used to test for the treatment effect. Otherwise, a non-parametric test (Wilcoxon signed rank test) is used.|Mean Difference (Final Values)|-6.4|||<|0.001|TWO_SIDED|95.0|-7.957|-4.787|||Paired t-test|||||-4.787|-7.957|<0.001
71810944|NCT02953938|143123614|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_DEVIATION|0.64||0.368|TWO_SIDED|95.0|-1.49|1.07|||Cochran-Mantel-Haenszel|||||1.07|-1.49|0.3680
71810945|NCT02953938|143123615|SUPERIORITY||Mean Difference (Final Values)|-6.58|STANDARD_DEVIATION|3.042||0.0349|TWO_SIDED|95.0|-12.67|-0.48|||ANOVA|||||-0.48|-12.67|0.0349
71810946|NCT02953938|143123616|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.051||0.2707|TWO_SIDED|95.0|-0.045|0.158|||ANOVA|||||0.158|-0.045|0.2707
71810947|NCT02953938|143123618|SUPERIORITY||Mean Difference (Final Values)|11.32||||0.7602|TWO_SIDED|95.0|-62.65|85.28|||ANOVA|||||85.28|-62.65|0.7602
71810948|NCT04274894|143123635|NON_INFERIORITY|"The hypothesis for the primary safety analysis is:~H0: Change in 24-hour average SBP from Baseline to EOT ≥ 3 mmHg Vs. H1: Change in 24-hour average SBP from Baseline to EOT \< 3 mmHg"|LS Mean Change from Baseline to EOT|1.9|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|0.63|3.13||||||The primary endpoint of change from Baseline to End of Treatment (EOT) in average 24-hour SBP was evaluated using a linear regression model with change in average 24-hour SBP from Baseline to EOT as the dependent variable, centralized baseline average 24-hour SBP, ongoing medical history of hypertension, and pooled study center as covariates in the per protocol population.||3.13|0.63|
71810949|NCT03848403|143123641|SUPERIORITY||Least Squares (LS) Means Difference|-21.69|||<|0.0001|TWO_SIDED|95.0|-26.9|-16.48|||Mixed Models Analysis|||||-16.48|-26.90|<0.0001
71810950|NCT03848403|143123641|SUPERIORITY||LS Means Difference|-21.14|||<|0.0001|TWO_SIDED|95.0|-26.39|-15.88|||Mixed Models Analysis|||||-15.88|-26.39|<0.0001
71810951|NCT03848403|143123641|SUPERIORITY||LS Means Difference|0.55||||0.8341|TWO_SIDED|95.0|-4.65|5.75|||Mixed Models Analysis|||||5.75|-4.65|0.8341
71810952|NCT02279043|143123642|SUPERIORITY||Odds Ratio (OR)|0.88||||0.89|TWO_SIDED|95.0|0.16|4.88|||Regression, Logistic|||||4.88|0.16|0.89
71810953|NCT02279043|143123643|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71810954|NCT02279043|143123644|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71810955|NCT02279043|143123644|SUPERIORITY||Slope|0.59||||0.02|TWO_SIDED|95.0|0.08|1.11|||Regression, Linear|||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.11|0.08|0.02
71810956|NCT02279043|143123645|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71810957|NCT02279043|143123646|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||||||0.08
71810958|NCT02279043|143123647|SUPERIORITY||Odds Ratio (OR)|1.29||||0.34|TWO_SIDED|95.0|0.75|2.2|||Regression, Logistic|||||2.20|0.75|0.34
71810959|NCT02279043|143123648|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.49|2.05|||Regression, Logistic|||||2.05|0.49|0.99
71810960|NCT02279043|143123649|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||||2.29|0.95|0.08
71810961|NCT02279043|143123650|SUPERIORITY||Odds Ratio (OR)|1.63||||0.03|TWO_SIDED|95.0|1.05|2.58|||Regression, Logistic|||||2.58|1.05|0.03
71810962|NCT02279043|143123650|SUPERIORITY||Slope|0.5||||0.03|TWO_SIDED|95.0|0.04|0.97|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||0.97|0.04|0.03
71810963|NCT02279043|143123651|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.01|TWO_SIDED|95.0|1.42|3.56|||Regression, Logistic|||||3.56|1.42|<0.01
71810964|NCT02279043|143123651|SUPERIORITY||Slope|0.84|||<|0.01|TWO_SIDED|95.0|0.33|1.35|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.||1.35|0.33|<0.01
71810965|NCT02279043|143123652|SUPERIORITY||Odds Ratio (OR)|1.02||||0.93|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.93
71810966|NCT02279043|143123653|SUPERIORITY||Odds Ratio (OR)|1.19||||0.68|TWO_SIDED|95.0|0.52|2.74|||Regression, Logistic|||||2.74|0.52|0.68
71810967|NCT02279043|143123654|SUPERIORITY||Odds Ratio (OR)|1.24||||0.33|TWO_SIDED|95.0|0.08|1.93|||Regression, Logistic|||||1.93|0.08|0.33
71810968|NCT01939548|143123657|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.11|STANDARD_ERROR_OF_MEAN|2.409||0.1991|TWO_SIDED|80.0|0.01|6.21||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||6.21|0.01|0.1991
71810969|NCT01939548|143123657|SUPERIORITY_OR_OTHER||LSM Difference|2.3|STANDARD_ERROR_OF_MEAN|2.445||0.3488|TWO_SIDED|80.0|-0.85|5.45||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.||5.45|-0.85|0.3488
71810970|NCT01939548|143123658|SUPERIORITY_OR_OTHER||LSM Difference|-0.23|STANDARD_ERROR_OF_MEAN|1.476||0.8786|TWO_SIDED|80.0|-2.13|1.67||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.67|-2.13|0.8786
71810971|NCT01939548|143123658|SUPERIORITY_OR_OTHER||LSM Difference|-1.14|STANDARD_ERROR_OF_MEAN|1.502||0.4483|TWO_SIDED|80.0|-3.08|0.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.79|-3.08|0.4483
71810972|NCT01939548|143123659|SUPERIORITY_OR_OTHER||LSM Difference|0.81|STANDARD_ERROR_OF_MEAN|0.809||0.3201|TWO_SIDED|80.0|-0.23|1.85||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.85|-0.23|0.3201
71810973|NCT01939548|143123659|SUPERIORITY_OR_OTHER||LSM Difference|0.85|STANDARD_ERROR_OF_MEAN|0.813||0.2961|TWO_SIDED|80.0|-0.19|1.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.90|-0.19|0.2961
71810974|NCT01939548|143123659|SUPERIORITY_OR_OTHER||LSM Difference|0.39|STANDARD_ERROR_OF_MEAN|0.743||0.6015|TWO_SIDED|80.0|-0.57|1.35||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.35|-0.57|0.6015
71810975|NCT01939548|143123659|SUPERIORITY_OR_OTHER||LSM Difference|0.21|STANDARD_ERROR_OF_MEAN|0.761||0.7787|TWO_SIDED|80.0|-0.77|1.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.19|-0.77|0.7787
71813963|NCT00674570|143129782|SUPERIORITY||Median Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.06|=|0.43|TWO_SIDED|95.0|-0.07|0.18|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.18|-.07|=.43
71676602|NCT03521115|142871060|SUPERIORITY||b|0.72|||<|0.05|TWO_SIDED||||||generalized estimating equations|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||<0.05
71810976|NCT01939548|143123659|SUPERIORITY_OR_OTHER||LSM Difference|1.63|STANDARD_ERROR_OF_MEAN|1.285||0.2068|TWO_SIDED|80.0|-0.02|3.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||3.29|-0.02|0.2068
71810977|NCT01939548|143123659|SUPERIORITY_OR_OTHER||LSM Difference|0.98|STANDARD_ERROR_OF_MEAN|1.326||0.4611|TWO_SIDED|80.0|-0.73|2.69||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.69|-0.73|0.4611
71813964|NCT00674570|143129782|SUPERIORITY||Median Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.06|=|0.47|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||Fear Conditioning End (last trial)||.17|-.07|=.47
71813965|NCT00674570|143129782|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.05|=|0.065|TWO_SIDED|95.0|-0.01|0.2|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.20|-.01|=.065
71813966|NCT00674570|143129782|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.05|=|0.34|TWO_SIDED|95.0|-0.05|0.15|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)||.15|-.05|=.34
71813967|NCT00674570|143129782|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05|=|0.003|TWO_SIDED|95.0|0.06|0.26|||Mixed Models Analysis|||Extinction End (last trial)||.26|.06|=.003
71813968|NCT00674570|143129782|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.02|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|||Extinction End (last trial)||.22|.02|.02
71813969|NCT00674570|143129782|OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06|=|0.006|TWO_SIDED|95.0|0.05|0.3|||Mixed Models Analysis|||Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.||.30|.05|=.006
71813970|NCT00674570|143129782|OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06|=|0.01|TWO_SIDED|95.0|0.04|0.28|||Mixed Models Analysis|||Extinction retention||.28|.04|=.01
71813971|NCT01966003|143129783|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).|Risk Ratio (RR)|0.93|||||TWO_SIDED|90.0|0.8|1.09||||||The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).||1.09|0.80|
71813972|NCT01966003|143129783|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.9|||||TWO_SIDED|90.0|-9.26|3.45||||||Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.||3.45|-9.26|
71813973|NCT01966003|143129785|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||||TWO_SIDED|90.0|0.83|1.29||||||The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.29|0.83|
71813974|NCT01966003|143129788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|90.0|0.75|1.61||||||Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.||1.61|0.75|
71813975|NCT00141739|143129798|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test||||||0.001
71813976|NCT03299686|143129818|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_DEVIATION|0.043||0.7374|TWO_SIDED|80.0|-0.029|0.082||Probability CJM112 better than placebo|Bayesian linear repeated measures model||||Lower limit and upper limit represents the Credibility Interval from the Bayesian analysis.|0.082|-0.029|0.7374
71813977|NCT03299686|143129819|SUPERIORITY||Mean Difference (Net)|0.913|STANDARD_ERROR_OF_MEAN|1.434||0.263|TWO_SIDED|80.0|-0.939|2.766||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||2.766|-0.939|0.263
71813978|NCT03299686|143129820|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.14||0.061|TWO_SIDED|80.0|-0.41|-0.04||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.04|-0.41|0.061
71813979|NCT03299686|143129821|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|80.0|-0.4|-0.06||1-sided p-value; p-value smaller than 0.1 is considered as statistically significant|Mixed Models Analysis|||||-0.06|-0.40|0.040
71813980|NCT01320943|143129824|SUPERIORITY|||||||0.022||||||Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.|Log Rank|||||||0.022
71813981|NCT00361439|143129837|SUPERIORITY_OR_OTHER||||||<|0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.02
71813982|NCT00361439|143129838|SUPERIORITY_OR_OTHER||||||<|0.023||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.023
71813983|NCT00361439|143129839|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||||||<0.002
71813984|NCT00361439|143129840|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.010
71813985|NCT00755040|143129842|SUPERIORITY||Odds Ratio (OR)|1.11|||>|0.99|TWO_SIDED|95.0|||||Fisher Exact|||||||>0.99
71813986|NCT00733980|143129844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2479||||0.703||80.0|-0.5887|1.0846|||Mixed-Model Repeated-Measure analysis|||||1.0846|-0.5887|0.703
71810978|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|0.96|STANDARD_ERROR_OF_MEAN|0.591||0.1083|TWO_SIDED|80.0|0.19|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|0.19|0.1083
71810979|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|0.611||0.0869|TWO_SIDED|80.0|0.27|1.84||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.84|0.27|0.0869
71810980|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.575||0.8601|TWO_SIDED|80.0|-0.84|0.64||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.64|-0.84|0.8601
71810981|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.593||0.3454|TWO_SIDED|80.0|-1.33|0.2||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.20|-1.33|0.3454
71810982|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|0.78|STANDARD_ERROR_OF_MEAN|0.789||0.3273|TWO_SIDED|80.0|-0.24|1.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.79|-0.24|0.3273
71810983|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|0.69|STANDARD_ERROR_OF_MEAN|0.806||0.3963|TWO_SIDED|80.0|-0.35|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.72|-0.35|0.3963
71810984|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|0.64|STANDARD_ERROR_OF_MEAN|0.888||0.4713|TWO_SIDED|80.0|-0.5|1.78||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||1.78|-0.50|0.4713
71810985|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|1.21|STANDARD_ERROR_OF_MEAN|0.895||0.1787|TWO_SIDED|80.0|0.06|2.36||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||2.36|0.06|0.1787
71810986|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.426||0.4123|TWO_SIDED|80.0|-0.2|0.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.90|-0.20|0.4123
71810987|NCT01939548|143123660|SUPERIORITY_OR_OTHER||LSM Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.441||0.3202|TWO_SIDED|80.0|-1.01|0.13||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.13|-1.01|0.3202
71813987|NCT00733980|143129845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0169||||0.966|TWO_SIDED|80.0|-0.5231|0.4893|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 1||0.4893|-0.5231|0.966
71895475|NCT00320671|143313543|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|56.8||||0.61|TWO_SIDED|95.0|43.9|69.9|||Log Rank||Only the subjects taking risperidone were analysed in this section|||69.9|43.9|.61
71895476|NCT00320671|143313543|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Analysis|Cumulative Response Rates|62.8||||0.61|TWO_SIDED|95.0|50.8|74.8|||Log Rank||Only subjects taking aripiprazole were analysed in this section|||74.8|50.8|.61
71810988|NCT01939548|143123661|SUPERIORITY_OR_OTHER||LSM Difference|0.04|STANDARD_ERROR_OF_MEAN|0.119||0.7399|TWO_SIDED|80.0|-0.11|0.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.19|-0.11|0.7399
71810989|NCT01939548|143123661|SUPERIORITY_OR_OTHER||LSM Difference|0.13|STANDARD_ERROR_OF_MEAN|0.122||0.2747|TWO_SIDED|80.0|-0.02|0.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.||0.29|-0.02|0.2747
71810990|NCT01939548|143123662|SUPERIORITY_OR_OTHER||LSM Difference|0.07|STANDARD_ERROR_OF_MEAN|0.188||0.7219|TWO_SIDED|80.0|-0.17|0.31||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.31|-0.17|0.7219
71810991|NCT01939548|143123662|SUPERIORITY_OR_OTHER||LSM Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.192||0.9315|TWO_SIDED|80.0|-0.26|0.23||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.||0.23|-0.26|0.9315
71810992|NCT00101933|143123680|SUPERIORITY_OR_OTHER|||||||0.0017||95.0||||Since a treatment-by-visit interaction remains in the final model, the results were analyzed by visit. The results shown are for the last month in the blinded phase (month 3-4).|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0017
71810993|NCT00101933|143123682|SUPERIORITY_OR_OTHER||Rate per 1000 years of stimulation|4.9|||||TWO_SIDED|95.0|0.6|17.79|||No statistical test||The rate is calculated per 1000 subject years of follow-up based on 406 subject years of stimulation. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP were included in the calculation.|||17.79|0.60|
71810994|NCT00101933|143123683|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Fisher Exact|||Fisher's Exact test. The numbers presented in this analysis are the number of subjects who were responders based on a responder definition including all subjects with 50% or greater improvement in total seizure count.||||0.830
71810995|NCT00101933|143123684|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.105
71810996|NCT00101933|143123685|SUPERIORITY_OR_OTHER|||||||0.498||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.498
71810997|NCT00101933|143123686|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71810998|NCT00101933|143123687|SUPERIORITY_OR_OTHER|||||||0.0387||95.0||||Since a visit-by-treatment interaction did not remain in the final model, the results shown are for the entire blinded phase.|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.||||0.0387
71810999|NCT00101933|143123688|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Wilcoxon (Mann-Whitney)|||Numbers provided indicate the percentage change from baseline in seizure frequency of each participant's most severe seizures. Negative values indicate improvement from baseline.||||0.047
71811000|NCT00774579|143123692|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
71811001|NCT00774579|143123693|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71811002|NCT01499082|143123730|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.112|0.107||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.||0.107|-0.112|
71844116|NCT02307682|143202439|OTHER||Difference in proportions|4.8|||||TWO_SIDED|95.0|-1.5|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||11.4|-1.5|
71811003|NCT01499082|143123731|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.79||||0.0045|TWO_SIDED|95.0|0.67|0.93|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (\<8.0 and \>=8.0%).||0.93|0.67|0.0045
71811004|NCT01499082|143123732|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.162||0.6909|TWO_SIDED|95.0|-0.383|0.254|||ANCOVA|||Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (\<8.0 and \>=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.||0.254|-0.383|0.6909
71844117|NCT02307682|143202439|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-5.9|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.1|-5.9|
71676603|NCT03521115|142871061|SUPERIORITY||||||>|0.1|||||||Chi-squared|||Among those assigned to intervention, dosage was assigned as 0 for no exposure, 1 for completing some of the program, and 2 for completing the relationship component. A probit analysis predicting completion was conducted from baseline measures and an instrumental variable, inverse Mills' ratio (IMR) representing the underlying selection processes was included as a covariate accounting for factors related to program completion. All controls were assigned 0 dosage.||||>0.10
71811005|NCT01499082|143123741|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.123|||TWO_SIDED|95.0|-0.189|0.298||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.||0.298|-0.189|
71676604|NCT04501640|142871079|OTHER||Geomteric Least Squares (LS) Mean Ratio|57.06|||||TWO_SIDED|90.0|46.21|70.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an analysis of variance (ANOVA) performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.47|46.21|
71811006|NCT00567190|143123755|SUPERIORITY||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75||Tested at two-sided 5% significance level|Log Rank (stratified)|Stratified by prior treatment status and region|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.75|0.51|<0.0001
71811007|NCT00567190|143123755|SUPERIORITY||Cox Proportional Hazard|0.63|||<|0.0001|TWO_SIDED|95.0|0.52|0.76||Tested at two-sided 5% significance level|Log Rank (unstratified)|Unstratified|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.||0.76|0.52|<0.0001
71811008|NCT00567190|143123756|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.82||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.82|0.58|<0.0001
71811009|NCT00567190|143123756|SUPERIORITY|Exploratory|Cox Proportional Hazard|0.68||||0.0002|TWO_SIDED|95.0|0.56|0.84||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.||0.84|0.56|0.0002
71811010|NCT00567190|143123756|SUPERIORITY||Cox Proportional Hazard|0.66||||0.0008|TWO_SIDED|95.0|0.52|0.84||The threshold for statistical significance was HR≤0.739, p≤0.0138.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.|Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.||0.84|0.52|0.0008
71811011|NCT00567190|143123756|SUPERIORITY||Cox Proportional Hazard|0.64||||0.005|TWO_SIDED|95.0|0.47|0.88||The threshold for statistical significance was HR≤0.603, p≤0.0012.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing pertuzumab with placebo arms.|First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.||0.88|0.47|0.0050
71811012|NCT00567190|143123757|SUPERIORITY||Cox Proportional Hazard|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|PFS by Investigator - Stratified||0.81|0.59|<0.0001
71811013|NCT00567190|143123758|SUPERIORITY||Difference in Objective Response Rates|10.83||||0.0011|TWO_SIDED|95.0|4.2|17.5|||Mantel Haenszel|Stratified by prior treatment status and region.|Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.|Difference in Objective Response (CR + PR) Between Arms||17.5|4.2|0.0011
71811014|NCT00567190|143123758|SUPERIORITY||Odds Ratio (OR)|1.79|||||TWO_SIDED|95.0|1.26|2.54||||||Odds Ratio for Objective Response (CR + PR)||2.54|1.26|
71811015|NCT00567190|143123759|SUPERIORITY||Cox Proportional Hazard|0.66|||||TWO_SIDED|95.0|0.51|0.85||||||||0.85|0.51|
71811016|NCT00567190|143123760|SUPERIORITY||Cox Proportional Hazard|0.97||||0.7161|TWO_SIDED|95.0|0.81|1.16||Stratified by prior treatment status and region.|Log Rank (stratified)||Hazard ratio is comparing Pertuzumab arm with Placebo arm.|||1.16|0.81|0.7161
71811017|NCT00567190|143123769|OTHER|||||||0.7174|||||||Wilcoxon Rank Sum Test|||Wilcoxon Test of Maximum Decrease in LVEF From BL||||0.7174
71811018|NCT02532179|143123774|SUPERIORITY||Mean Ratio|3.0|||<|0.001|TWO_SIDED|95.0|2.09|4.29||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||4.29|2.09|<0.001
71895477|NCT03334214|143313551|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
71811019|NCT02532179|143123775|SUPERIORITY||Mean Ratio|3.82|||<|0.001|TWO_SIDED|95.0|2.77|5.25||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||5.25|2.77|<0.001
71895478|NCT03334214|143313552|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
71811020|NCT02532179|143123776|SUPERIORITY||Mean Ratio|6.55|||<|0.001|TWO_SIDED|95.0|3.87|11.06||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis|||||11.06|3.87|<0.001
71813988|NCT00733980|143129845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4299||||0.386|TWO_SIDED|80.0|-0.2063|1.0661|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 2||1.0661|-0.2063|0.386
71813989|NCT00733980|143129845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9413||||0.095|TWO_SIDED|80.0|0.2203|1.6624|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 4||1.6624|0.2203|0.095
71813990|NCT00733980|143129846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9495||||0.209|TWO_SIDED|80.0|-0.0185|1.9175|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.9175|-0.0185|0.209
71813991|NCT00733980|143129846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7638||||0.409|TWO_SIDED|80.0|-0.4243|1.9519|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||1.9519|-0.4243|0.409
71676605|NCT04501640|142871079|OTHER||Geometric LSMean Ratio|61.42|||||TWO_SIDED|90.0|52.06|72.47|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.47|52.06|
71676606|NCT04501640|142871080|OTHER||Geomteric LSMean Ratio|53.31|||||TWO_SIDED|90.0|43.02|66.05|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||66.05|43.02|
71676607|NCT04501640|142871080|OTHER||Geomteric LSMean Ratio|59.14|||||TWO_SIDED|90.0|49.48|70.7|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||70.70|49.48|
71895479|NCT03334214|143313555|SUPERIORITY|||||||0.024|||||||ANOVA|||||||0.024
71895480|NCT03334214|143313556|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|The p-value is obtained using Cochran-Mantel-Haenszel (CMH) test stratified by the baseline liver fat stratum (\<20%, ≥20%) stratification factor.||||||0.0774
71895481|NCT03334214|143313557|SUPERIORITY|||||||0.183|||||||ANOVA|||||||0.183
71813992|NCT00733980|143129846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5363||||0.156|TWO_SIDED|80.0|0.1485|2.9241|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9241|0.1485|0.156
71813993|NCT00733980|143129846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6327||||0.599|TWO_SIDED|80.0|-0.9135|2.1789|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.1789|-0.9135|0.599
71813994|NCT00733980|143129847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9866||||0.181|TWO_SIDED|80.0|-3.8876|-0.0856|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||-0.0856|-3.8876|0.181
71813995|NCT00733980|143129847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2538||||0.889|TWO_SIDED|80.0|-2.5922|2.0846|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.0846|-2.5922|0.889
71813996|NCT00733980|143129847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3242||||0.867|TWO_SIDED|80.0|-2.8165|2.1681|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 3||2.1681|-2.8165|0.867
71813997|NCT00733980|143129847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8107||||0.721|TWO_SIDED|80.0|-2.1036|3.7251|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||3.7251|-2.1036|0.721
71813998|NCT00733980|143129847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6273||||0.801|TWO_SIDED|80.0|-3.8337|2.5791|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.5791|-3.8337|0.801
71813999|NCT00733980|143129848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.644||||0.355|TWO_SIDED|80.0|-0.2498|1.5378|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1||1.5378|-0.2498|0.355
71814000|NCT00733980|143129848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0524||||0.249|TWO_SIDED|80.0|-0.1194|2.2243|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2||2.2243|-0.1194|0.249
71814001|NCT00733980|143129848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6473||||0.116|TWO_SIDED|80.0|0.3078|2.9868|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4||2.9868|0.3078|0.116
71814002|NCT00733980|143129848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7283||||0.55|TWO_SIDED|80.0|-0.8353|2.292|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6||2.2920|-0.8353|0.550
71814003|NCT00733980|143129852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6359||||0.3588|TWO_SIDED|80.0|0.3378|1.1968|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 2||1.1968|0.3378|0.3588
71814004|NCT00733980|143129852|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7347||||0.4088|TWO_SIDED|80.0|0.4554|1.1853|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 4||1.1853|0.4554|0.4088
71814005|NCT00733980|143129852|SUPERIORITY_OR_OTHER||Logistic Model|0.9211||||0.8156|TWO_SIDED|80.0|0.5863|1.4471|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal||1.4471|0.5863|0.8156
71814006|NCT00733980|143129853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4466||||0.361|TWO_SIDED|80.0|-1.3986|8.2917|||ANCOVA|||||8.2917|-1.3986|0.361
71814007|NCT00733980|143129854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1167||||0.932|TWO_SIDED|80.0|-1.6387|1.8722|||ANCOVA|||||1.8722|-1.6387|0.932
71814008|NCT00975221|143129975|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel (CMH) statistic|39.866|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71814009|NCT00975221|143129976|SUPERIORITY_OR_OTHER||CMH statistic|40.953|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71814010|NCT00975221|143129977|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-13.55|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|-16.23|-10.88|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-10.88|-16.23|<0.001
71814011|NCT00975221|143129978|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.79|STANDARD_ERROR_OF_MEAN|5.61|<|0.001|TWO_SIDED|95.0|-34.01|-11.57|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo|||-11.57|-34.01|<0.001
71814012|NCT01782742|143130012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided|||||0.03|-0.13|0.22
71814013|NCT01782742|143130013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.57|TWO_SIDED|95.0|-4.428|2.428|||t-test, 2 sided|||||2.428|-4.428|0.57
71814014|NCT01782742|143130014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.625||||0.83|TWO_SIDED|95.0|-5.029|6.279|||t-test, 2 sided|||||6.279|-5.029|0.83
71814015|NCT01782742|143130015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.000|0.000|
71814016|NCT01782742|143130016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375||||0.94|TWO_SIDED|95.0|-9.674|8.924|||t-test, 2 sided|||||8.924|-9.674|0.94
71814017|NCT01782742|143130017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.563||||0.18|TWO_SIDED|95.0|-1.975|11.1|||t-test, 2 sided|||||11.100|-1.975|0.18
71814018|NCT01782742|143130025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006||||0.46|TWO_SIDED|95.0|-0.01|0.021|||t-test, 2 sided|||||0.021|-0.010|0.46
71814019|NCT01782742|143130026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.53|TWO_SIDED|95.0|-0.02|0.04|||t-test, 2 sided|||||0.040|-0.020|0.53
71814020|NCT00332332|143130027|SUPERIORITY_OR_OTHER||Percentage of participants|73.5||||||95.0|67.2|79.1||||||||79.1|67.2|
71814021|NCT02790073|143130038|OTHER|Within group comparison vs baseline|||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
71811021|NCT00789815|143123809|NON_INFERIORITY_OR_EQUIVALENCE|A preliminary study was performed to determine the sample size before this trial. 15 and 15 patients undergoing FB received BIS-guided propofol sedation and clinical-judged midazolam sedation, respectively. The incidences of hypoxemia were 0.33 and 0.20, respectively. The selected sample size of 225 in each group will yield 90% power for detecting a clinically meaningful difference of 0.13 at the 5.0% level of significance. To allow for 10% missing data, we recruited 250 patients per group.||||||0.05||95.0|||||Chi-squared|||"The null hypothesis: the incidence of hypoxemia occured during FB with BIS-guided propofol infusion is higher than that with clinical-judged midazolam administration.~Power calculation is described below."||||0.05
71811022|NCT00789815|143123810|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The null hypothesis: the incidence of hypotension during FB in patients of study group is higher than that in the control group.||||0.05
71811023|NCT00789815|143123811|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
71811024|NCT00789815|143123812|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
71811025|NCT00789815|143123813|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
71811026|NCT00789815|143123814|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the global tolerance of patients in study is worse than that in the control group.||||0.05
71811027|NCT00789815|143123815|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.05
71676608|NCT04501640|142871081|OTHER||Geometric LSMean Ratio|38.93|||||TWO_SIDED|90.0|26.78|56.59|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||56.59|26.78|
71811028|NCT00789815|143123816|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
71811029|NCT01321554|143123817|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.21|||||TWO_SIDED|99.0|0.14|0.31||||||||0.31|0.14|
71811030|NCT01111123|143123821|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||CI of 95%|Log Rank|||Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.||||<0.05
71811031|NCT01111123|143123822|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANCOVA|||Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups||||<0.05
71811032|NCT04676425|143123830|OTHER||Least-Squares Geometric Mean Ratio|1.19|||||TWO_SIDED|90.0|0.7|2.01|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||2.01|0.70|
71811033|NCT04676425|143123831|OTHER||Least-Squares Geometric Mean Ratio|1.22|||||TWO_SIDED|90.0|0.86|1.74|||||Moderate hepatic impairment participants represent the numerator and healthy participants represent the denominator in the geometric mean ratio.|||1.74|0.86|
71811034|NCT00662857|143123842|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.982|||||TWO_SIDED|90.0|0.846|1.141|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.141|0.846|
71811035|NCT00662857|143123843|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.951|||||TWO_SIDED|90.0|0.823|1.099|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||1.099|0.823|
71811036|NCT00662857|143123844|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3531|||||||Signed Rank Test|||||||0.3531
71811037|NCT00662857|143123845|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.46|||||TWO_SIDED|90.0|0.366|0.578|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."|||0.578|0.366|
71811038|NCT00990964|143123861|SUPERIORITY_OR_OTHER||One sample proportion|0.94|||||TWO_SIDED|95.0|0.929|0.951||||||||.951|.929|
71811039|NCT00990964|143123862|SUPERIORITY_OR_OTHER||One sample proportion|0.974|||||TWO_SIDED|95.0|0.965|0.98||||||||.980|.965|
71811040|NCT00514943|143123870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49||||0.7606|TWO_SIDED|95.0|-11.188|8.202||P-value obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions.|ANCOVA|Receipt of prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance for target lesions are covariates|Mean difference calculated is actually the adjusted mean difference.|||8.202|-11.188|0.7606
71811041|NCT00514943|143123883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.764|TWO_SIDED|95.0|0.64|1.387|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.387|0.640|0.764
71811042|NCT00514943|143123884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.725||||0.219|TWO_SIDED|95.0|0.434|1.212|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.212|0.434|0.219
71811043|NCT00514943|143123885|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.067||||0.758|TWO_SIDED|95.0|0.708|1.608|||Regression, Cox||Hazard ratio, 95% CI and p-value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or \>=1)|||1.608|0.708|0.758
71814022|NCT02790073|143130039|OTHER|Within group comparison vs baseline||||||0.015|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.015
71814023|NCT02790073|143130040|OTHER|Within group comparison vs baseline||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
71814024|NCT02243202|143130057|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.8|||Mixed Model for Repeated Measures|||||-1.8|-5.3|<0.001
71814025|NCT02243202|143130057|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.142|TWO_SIDED|95.0|-3.1|0.4|||Mixed Model for Repeated Measures|||||0.4|-3.1|0.142
71811044|NCT01755702|143123982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.284|TWO_SIDED|95.0|0.83|1.9|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.90|0.83|0.2840
71811045|NCT01755702|143123982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.2008|TWO_SIDED|95.0|0.86|2.01|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||2.01|0.86|0.2008
71811046|NCT01755702|143123982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.4552|TWO_SIDED|95.0|0.78|1.74|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.74|0.78|0.4552
71811047|NCT01755702|143123982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.5579|TWO_SIDED|95.0|0.75|1.71|||Cox Proportional Hazard Model|||||1.71|0.75|0.5579
71811048|NCT01755702|143123982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.7214|TWO_SIDED|95.0|0.72|1.61|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.61|0.72|0.7214
71811049|NCT01755702|143123982|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.8192|TWO_SIDED|95.0|0.62|1.45|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.||1.45|0.62|0.8192
71811050|NCT03786952|143124013|SUPERIORITY|||||||0.453|||||||ANOVA|||||||0.453
71811051|NCT03786952|143124014|SUPERIORITY|||||||0.931|||||||ANOVA|||||||0.931
71811052|NCT03786952|143124015|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
71811053|NCT03786952|143124016|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
71811054|NCT03786952|143124017|SUPERIORITY|||||||0.872|||||||ANOVA|||||||0.872
71811055|NCT03786952|143124018|SUPERIORITY|||||||0.998|||||||ANOVA|||||||0.998
71895482|NCT03334214|143313558|SUPERIORITY|||||||0.682|||||||ANOVA|||Total Cholesterol||||0.682
71811056|NCT03786952|143124019|SUPERIORITY|||||||0.1|||||||ANOVA|||||||0.10
71811057|NCT03786952|143124020|SUPERIORITY|||||||0.992|||||||ANOVA|||||||0.992
71811058|NCT03786952|143124021|SUPERIORITY|||||||0.519|||||||ANOVA|||||||0.519
71811059|NCT03786952|143124022|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
71811060|NCT03786952|143124023|SUPERIORITY|||||||0.457|||||||ANOVA|||||||0.457
71811061|NCT03786952|143124024|SUPERIORITY|||||||0.415|||||||ANOVA|||||||0.415
71811062|NCT03786952|143124025|SUPERIORITY|||||||0.923|||||||ANOVA|||||||0.923
71811063|NCT03786952|143124026|SUPERIORITY|||||||0.981|||||||ANOVA|||||||0.981
71811064|NCT03786952|143124027|SUPERIORITY|||||||0.627|||||||ANOVA|||||||0.627
71811065|NCT03786952|143124028|SUPERIORITY|||||||0.901|||||||ANOVA|||||||0.901
71811066|NCT03786952|143124029|SUPERIORITY|||||||0.166|||||||ANOVA|||||||0.166
71811067|NCT03786952|143124030|SUPERIORITY|||||||0.252|||||||ANOVA|||||||0.252
71811068|NCT02782169|143124039|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.32
71811069|NCT02038894|143124058|NON_INFERIORITY|A previous study for evaluating respiratory complications with intubated and insufflated techniques found a difference in the incidence of respiratory complications of 9.1%, a power analysis was determined. 200 subjects per group was estimated provide 82% power to detect a difference. We elected to do an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications.|Odds Ratio (OR)|0.0|||<|0.0001|TWO_SIDED|95.0|0.0|0.14||Threshold for significance \<0.05 Comparing SPO2 \<95%|Mean equality test|||||0.14|0|<0.0001
71811070|NCT02038894|143124058|NON_INFERIORITY|A previous study found an incidence of respiratory complications of 9.1%. 200 subjects per group was estimated provide 82% power to detect a difference when conducting a two- sided test at a significance level of a = 0.05.We did an interim analysis when 60 children per group were recruited because of a clinical impression that one of the techniques had a grossly divergent incidence of respiratory complications. Based on the results of that interim analysis, recruitment was discontinued|Odds Ratio (OR)|0.0||||0.0001|TWO_SIDED|95.0|0.0|0.27||p\<0.05. Sp02\<85%|Mean equality test||Odds ratios were calculated to the respiratory complications comparing the different groups and by regrouping by the differences in airway management (IS + IP vs NA) and by the medication used for anesthesia maintenance (IS vs IP + NA)|||0.27|0|0.0001
71895483|NCT03334214|143313558|SUPERIORITY|||||||0.716|||||||ANOVA|||ApoB||||0.716
71895484|NCT03334214|143313558|SUPERIORITY|||||||0.717|||||||ANOVA|||HDL||||0.717
71895485|NCT03334214|143313558|SUPERIORITY|||||||0.463|||||||ANOVA|||LDL-C||||0.463
71895486|NCT03334214|143313558|SUPERIORITY|||||||0.555|||||||ANOVA|||Non-HDL||||0.555
71895487|NCT03334214|143313558|SUPERIORITY|||||||0.619|||||||ANOVA|||Triglycerides||||0.619
71895488|NCT03334214|143313558|SUPERIORITY|||||||0.698|||||||ANOVA|||VLDL-C||||0.698
71895489|NCT03334214|143313559|SUPERIORITY|||||||0.902|||||||ANOVA|||FPG||||0.902
71895490|NCT03334214|143313559|SUPERIORITY|||||||0.267|||||||Van Elteren test|||HOMA-IR||||0.267
71895491|NCT03334214|143313559|SUPERIORITY|||||||0.2|||||||Van Elteren test|||Insulin||||0.200
71895492|NCT03334214|143313560|SUPERIORITY|||||||0.933|||||||ANOVA|||||||0.933
71895493|NCT00736229|143313583|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison for the difference in Median glucose values during steady state across all three groups.|Kruskal-Wallis|||Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.||||<0.001
71895494|NCT00736229|143313583|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison of Median Glucose Values between Exenatide and Intensive Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||<0.001
71895495|NCT00736229|143313583|SUPERIORITY_OR_OTHER|||||||0.15||||||Comparison of Median Glucose Values between Exenatide and Moderate Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||0.15
71895496|NCT00736229|143313584|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.||||<0.001
71895497|NCT00736229|143313584|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.||||0.80
71811071|NCT02038894|143124059|NON_INFERIORITY|No previous data was available to calculate a power calculation for the secondary outcome.||||||0.901||||||Threshold of Significance|Mean equality test|||Total OR Time||||0.901
71811072|NCT02638948|143124113|SUPERIORITY||Estimate of Difference (%)|4.9||||0.5224|TWO_SIDED|95.0|-10.2|20.1||Threshold for significance = 0.05|Chi-squared|||||20.1|-10.2|0.5224
71811073|NCT02638948|143124113|SUPERIORITY||Estimate of Difference (%)|11.8||||0.136|TWO_SIDED|95.0|-3.6|27.2||Threshold for significance = 0.05|Chi-squared|||||27.2|-3.6|0.1360
71811074|NCT02638948|143124113|SUPERIORITY||Estimate of Difference (%)|0.1||||0.9922|TWO_SIDED|95.0|-20.5|20.7||Threshold for significance = 0.05|Chi-squared|||||20.7|-20.5|0.9922
71811075|NCT02638948|143124114|SUPERIORITY||Estimate of Difference (%)|0.1||||1|TWO_SIDED|95.0|-16.0|16.5||Threshold for significance = 0.05|Chi-squared|||||16.5|-16.0|1.0000
71811076|NCT02638948|143124114|SUPERIORITY||Estimate of Difference (%)|5.6||||0.2058|TWO_SIDED|95.0|-10.5|21.9||Threshold for significance = 0.05|Chi-squared|||||21.9|-10.5|0.2058
71811077|NCT02638948|143124114|SUPERIORITY||Estimate of Difference (%)|-0.2||||1|TWO_SIDED|95.0|-22.5|22.2||Threshold for significance = 0.05|Chi-squared|||||22.2|-22.5|1.0000
71811078|NCT02963974|143124138|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.||||< 0.001
71811079|NCT02963974|143124138|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)|||Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.||||< 0.001
71811080|NCT02963974|143124140|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05. This was a two-way repeated measures ANOVA.|ANOVA|||Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
71811081|NCT02963974|143124141|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.||||< 0.001
71811082|NCT02963974|143124145|SUPERIORITY|||||||0.01911||||||The a priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.||||0.01911
71811083|NCT02963974|143124146|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Speech subtest.||||< 0.001
71811084|NCT02963974|143124146|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Spatial subtest.||||0.001
71811085|NCT02963974|143124146|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores across time to investigate change in scores over time: Qualities subtest.||||< 0.001
71811086|NCT02963974|143124147|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores over time.||||< 0.001
71811087|NCT02963974|143124148|SUPERIORITY|||||||0.1009||||||The a priori threshold for statistical significance was p \< 0.05|Mixed Models Analysis|||Comparison of scores to evaluation change over time: General Fatigue Subtest||||0.1009
71811088|NCT02963974|143124148|SUPERIORITY|||||||0.109||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Sleep Fatigue Subtest||||0.109
71811089|NCT02963974|143124148|SUPERIORITY|||||||0.1733||||||The a priori threshold for statistical significance was p \< 0.05.|Mixed Models Analysis|||Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest||||0.1733
71811090|NCT00810264|143124149|NON_INFERIORITY|The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.|||||<|0.0001|||||||Binomial Proportion|||||||<0.0001
71811091|NCT00313820|143124187|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.29||0.578||95.0|-0.7|0.4|||ANCOVA|ANCOVA with treatment and country as factors and baseline pain score as covariate.||Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo||0.4|-0.7|0.578
71811092|NCT00313820|143124187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294||95.0||||Interaction p-value based on adding interaction term to the main model.|ANCOVA|||Modelled Results: Treatment by country interaction||||0.294
71814026|NCT02243202|143130057|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.9|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-8.6|-5.2|||Mixed Model for Repeated Measures|||||-5.2|-8.6|<0.001
71814027|NCT02243202|143130058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.15||||0.002|TWO_SIDED|95.0|1.7|10.14|||Generalized linear Mixed Model|||||10.14|1.70|0.002
71814028|NCT02243202|143130058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.825|TWO_SIDED|95.0|0.41|3.06|||Generalized linear Mixed Model|||||3.06|0.41|0.825
71814029|NCT02243202|143130058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.2|||<|0.001|TWO_SIDED|95.0|4.15|25.05|||Generalized linear Mixed Model|||||25.05|4.15|<0.001
71814030|NCT02243202|143130059|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.8||0.456|TWO_SIDED|95.0|-2.1|4.8|||Mixed Model for Repeated Measures|||||4.8|-2.1|0.456
71814031|NCT02243202|143130059|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.8||0.827|TWO_SIDED|95.0|-3.9|3.1|||Mixed Model for Repeated Measures|||||3.1|-3.9|0.827
71814032|NCT02243202|143130059|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.7||0.015|TWO_SIDED|95.0|-7.7|-0.8|||Mixed Model for Repeated Measures|||||-0.8|-7.7|0.015
71814033|NCT02243202|143130060|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.3|-1.7|||Mixed Model for Repeated Measures|||||-1.7|-5.3|<0.001
71814034|NCT02243202|143130060|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.153|TWO_SIDED|95.0|-3.1|0.5|||Mixed Model for Repeated Measures|||||0.5|-3.1|0.153
71676609|NCT04501640|142871081|OTHER||Geometric LSMean Ratio|47.9|||||TWO_SIDED|90.0|31.76|72.24|||||Ratios and confidence intervals are transformed back to raw scale \& values are expressed as percentages.|Assessment based on an ANOVA performed on natural log-transformed parameters with food condition and period as a fixed effects and participant as a random effect.||72.24|31.76|
71676610|NCT01981954|142871083|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 MCC Analysis||||<0.001
71676611|NCT01981954|142871085|OTHER|||||||0.003||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline=0.|t-test, 2 sided|||Week 24 Analysis||||0.003
71676612|NCT01981954|142871086|OTHER|||||||0.744||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.744
71676613|NCT01981954|142871087|OTHER|||||||0.352||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.352
71676614|NCT01981954|142871088|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
71676615|NCT01981954|142871089|OTHER|||||||0.177||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.177
71676616|NCT01981954|142871090|OTHER|||||||0.025||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analyis||||0.025
71811093|NCT00313820|143124188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.161||95.0|-0.8|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1 Modelled Results||0.1|-0.8|0.161
71811094|NCT00313820|143124188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.25||0.062||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2 Modelled Results||0.0|-1.0|0.062
71811095|NCT00313820|143124188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.024||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3 Modelled Results||-0.1|-1.1|0.024
71811096|NCT00313820|143124188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.25||0.026||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6 Modelled Results||-0.1|-1.1|0.026
71811097|NCT00313820|143124188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.105||95.0|-0.9|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9 Modelled Results||0.1|-0.9|0.105
71811098|NCT00313820|143124188|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.592||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12 Modelled Results||0.4|-0.6|0.592
71811099|NCT00313820|143124189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.087||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||30% Responders||||0.087
71844118|NCT02307682|143202439|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.1|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||9.7|-3.1|
71895498|NCT00736229|143313584|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.||||<0.001
71676617|NCT01981954|142871091|OTHER|||||||0.05||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.050
71676618|NCT01981954|142871092|OTHER|||||||0.567||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.567
71676619|NCT01981954|142871093|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
71676620|NCT01981954|142871094|OTHER||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||<0.001
71676621|NCT01981954|142871095|OTHER|||||||0.004||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.004
71676622|NCT01981954|142871096|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
71676623|NCT01981954|142871097|OTHER|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.001
71676624|NCT01981954|142871114|OTHER|||||||0.688||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.688
71676625|NCT01981954|142871115|OTHER|||||||0.61||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.610
71676626|NCT01981954|142871116|OTHER|||||||0.562||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.562
71676627|NCT01981954|142871117|OTHER|||||||0.657||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.657
71844119|NCT02307682|143202439|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-6.5|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.5|-6.5|
71844120|NCT02307682|143202439|OTHER||Difference in proportions|4.9|||||TWO_SIDED|95.0|-1.3|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.4|-1.3|
71844121|NCT02307682|143202439|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-2.9|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.2|-2.9|
71844122|NCT02307682|143202439|OTHER||Difference in proportions|5.8|||||TWO_SIDED|95.0|-0.4|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||12.3|-0.4|
71844123|NCT02307682|143202439|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.2|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.0|-4.2|
71844124|NCT02307682|143202439|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-0.2|11.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||11.9|-0.2|
71844125|NCT02307682|143202439|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.9|-3.0|
71844126|NCT02307682|143202439|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.1|11.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||11.4|-1.1|
71844127|NCT02307682|143202439|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-1.5|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||12.8|-1.5|
71844128|NCT02307682|143202439|OTHER||Difference in proportions|5.0|||||TWO_SIDED|95.0|-1.0|11.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||11.6|-1.0|
71844129|NCT02307682|143202439|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.6|-5.1|
71844130|NCT02307682|143202439|OTHER||Difference in proportions|8.8|||||TWO_SIDED|95.0|2.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||15.4|2.7|
71844131|NCT02307682|143202439|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.7|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.4|-3.7|
71844132|NCT02307682|143202439|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.2|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.3|-2.2|
71844133|NCT02307682|143202439|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-3.0|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.9|-3.0|
71844134|NCT02307682|143202439|OTHER||Difference in proportions|8.0|||||TWO_SIDED|95.0|1.9|14.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||14.6|1.9|
71844135|NCT02307682|143202439|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.1|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.1|
71844136|NCT02307682|143202439|OTHER||Difference in proportions|5.9|||||TWO_SIDED|95.0|0.0|12.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.5|-0.0|
71676628|NCT01981954|142871118|OTHER|||||||0.631||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.631
71676629|NCT01981954|142871119|OTHER|||||||0.41||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.410
71676630|NCT01981954|142871120|OTHER|||||||0.94||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.940
71811100|NCT00313820|143124190|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622||95.0||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||50% Responders||||0.622
71811101|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|-1.0|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1; Modelled Results||-0.1|-1.0|0.027
71811102|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.24||0.038||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2; Modelled Results||-0.0|-1.0|0.038
71811103|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.004||95.0|-1.2|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3; Modelled Results||-0.2|-1.2|0.004
71811104|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.24||0.005||95.0|-1.1|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6; Modelled Results||-0.2|-1.1|0.005
71811105|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.24||0.078||95.0|-0.9|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9; Modelled Results||0.0|-0.9|0.078
71844137|NCT02307682|143202439|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.2|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.3|-1.2|
71814035|NCT02243202|143130060|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-8.5|-4.9|||Mixed Model for Repeated Measures|||||-4.9|-8.5|<0.001
71676631|NCT01981954|142871121|OTHER|||||||1||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||1.000
71676632|NCT01981954|142871122|OTHER|||||||0.575||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|t-test, 2 sided|||Week 24 Analysis||||0.575
71676633|NCT01981954|142871123|OTHER|||||||0.031||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.031
71676634|NCT01981954|142871124|OTHER|||||||0.721||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis||||0.721
71676635|NCT03655470|142871125|SUPERIORITY||Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.07||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||.30
71814036|NCT02401464|143130074|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|Least Squares (LS) mean difference (ln)|0.963|||||TWO_SIDED|90.0|0.927|1.001||||||Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.||1.001|0.927|
71814037|NCT02401464|143130075|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.906|||||TWO_SIDED|90.0|0.88|0.933||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||0.933|0.880|
71814038|NCT02401464|143130076|NON_INFERIORITY_OR_EQUIVALENCE|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)- ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)-ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.985|||||TWO_SIDED|90.0|0.958|1.011||||||Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.||1.011|0.958|
71811106|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.663||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12; Modelled Results||0.4|-0.6|0.663
71811107|NCT00313820|143124191|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.627||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Endpoint \[Week 12 or ET\]; Modelled Results||0.4|-0.6|0.627
71811108|NCT00313820|143124192|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|3.05||0.741||95.0|-7.0|5.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate|ANCOVA|||Modelled Results||5.0|-7.0|0.741
71811109|NCT00313820|143124193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.216||95.0|-1.0|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Burning Pain Week 12 \[LOCF\]; Modelled Results||0.2|-1.0|0.216
71811110|NCT00313820|143124193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.76||95.0|-0.4|0.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Pressing Pain Week 12 \[LOCF\]; Modelled Results||0.6|-0.4|0.760
71811111|NCT00313820|143124193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.36||95.0|-0.7|0.3||Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Paroxysmal Pain Week 12 \[LOCF\]; Modelled Results||0.3|-0.7|0.360
71811112|NCT00313820|143124193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.26||0.239||95.0|-0.8|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Evoked Pain Week 12 \[LOCF\]; Modelled Results||0.2|-0.8|0.239
71811113|NCT00313820|143124193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.27||0.118||95.0|-1.0|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||P/D Week 12 \[LOCF\]; Modelled Results||0.1|-1.0|0.118
71811114|NCT00313820|143124193|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8|STANDARD_ERROR_OF_MEAN|1.87||0.138||95.0|-6.5|0.9||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Total Score Week 12 \[LOCF\]; Modelled Results||0.9|-6.5|0.138
71811115|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|2.79||0.086||95.0|-10.3|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep disturbance; Modelled Results||0.7|-10.3|0.086
71811116|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|3.72||0.039||95.0|0.4|15.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Snoring score; Modelled Results||15.1|0.4|0.039
71811117|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|2.71||0.169||95.0|-9.1|1.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Awaken SOB or headache; Modelled Results||1.6|-9.1|0.169
71811118|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03||95.0|0.0|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep quantity; Modelled Results||0.7|0.0|0.030
71811119|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|3.44||0.013||95.0|1.8|15.4||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep adequacy; Modelled Results||15.4|1.8|0.013
71811120|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.51||0.399||95.0|-2.8|7.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Somnolence; Modelled Results||7.1|-2.8|0.399
71811121|NCT00313820|143124194|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|2.13||0.049||95.0|-8.4|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Overall sleep problems index; Modelled Results||-0.0|-8.4|0.049
71811122|NCT00313820|143124195|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|STANDARD_ERROR_OF_MEAN|0.5||0.201||95.0|0.8|2.9||Estimated from a logistic regression model with treatment and the baseline assessment as factors.|Regression, Logistic||Standard error of the mean = standard error of the odds ratio.|Modelled Results||2.9|0.8|0.201
71811123|NCT00313820|143124196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.015||95.0|-1.8|-0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Anxiety score; Modelled Results||-0.2|-1.8|0.015
71676636|NCT01893281|142871128|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71811124|NCT00313820|143124196|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.6||95.0|-0.6|1.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 \[LOCF\] Depression score; Modelled Results||1.0|-0.6|0.600
71811125|NCT00313820|143124197|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.566||95.0|-0.1|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||0.1|-0.1|0.566
71811126|NCT00313820|143124198|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.47||0.22||95.0|-1.8|7.9||Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.|ANCOVA|||Modelled Results||7.9|-1.8|0.220
71676637|NCT05481125|142871131|NON_INFERIORITY|Non-inferiority margin = 0.1 logMAR|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.0125|||ONE_SIDED|95.0||-0.024||Since a non-inferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the non-inferiority margin.|||Mean difference (Clareon/Clareon Toric minus Eyhance/Eyhance Toric). Upper Confidence Limit is presented.|||-0.024||
71676638|NCT00422695|142871134|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71676639|NCT00422695|142871134|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71676640|NCT00355147|142871192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.69|TWO_SIDED||||||Mixed Models Analysis|Adjusted for site, strata, baseline score, randomized group, month and the group by month interaction|This score represents change from baseline to six months across the groups.|This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.||||0.69
71676641|NCT00355147|142871192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|0.23||0.05|TWO_SIDED|||||Adjusted for site, strata, baseline value, treatment group, month of assessment, treatment group x month, random subject effect|Mixed Models Analysis||This score represents change from baseline to three months across groups.|This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measure||||0.05
71676642|NCT00355147|142871193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.66|TWO_SIDED||||||Mixed Models Analysis|Adjusted by site, strata, baseline score, treatment group, month and group by month interaction|The score is the change from baseline to six months between groups.|||||0.66
71811127|NCT00313820|143124199|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.144||95.0|-0.5|0.1||Estimated from ANCOVA (general linear model) with treament and country as factors.|ANCOVA|||Modelled Results||0.1|-0.5|0.144
71676643|NCT00355147|142871194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.74||||0.06|TWO_SIDED|95.0|0.88|51.31|||Regression, Logistic|||||51.31|0.88|0.06
71811128|NCT00313820|143124200|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.049||95.0|-0.6|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors.|ANCOVA|||Modelled Results||-0.0|-0.6|0.049
71811129|NCT00251862|143124203|SUPERIORITY_OR_OTHER||Absolute Difference|8.3||||0.046|TWO_SIDED|95.0|-2.2|14.2|||Chi-squared|||Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P\<0.05 level.||14.2|-2.2|0.046
71811130|NCT00251862|143124203|SUPERIORITY_OR_OTHER||Absolute Difference|6.0||||0.153|TWO_SIDED|95.0|0.2|16.5|||Chi-squared|||||16.5|0.2|0.153
71811131|NCT00251862|143124204|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons: DA+YDR vs. Control, P\<0.001; DA alone vs. Control, P\<0.001|ANCOVA|||The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
71811132|NCT00251862|143124205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
71811133|NCT00251862|143124206|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni's adjusted multiple comparison procedure.||||<0.001
71811134|NCT02134587|143124216|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.00001
71811135|NCT02134587|143124217|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71676644|NCT00355147|142871194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45||||0.036|TWO_SIDED|95.0|1.08|10.96|||Regression, Logistic|||Within group Intervention Pre Post Comparison Compliance with Diabetes Medication||10.96|1.08|0.036
71676645|NCT00355147|142871194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.7|||Regression, Logistic|||Within Group attention control group intervention pre post comparison compliance with Diabetes Medication||2.70|0.10|0.407
71676646|NCT00355147|142871195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|0.54|4.48|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Statin Medication||4.48|0.54|0.05
71676647|NCT00355147|142871195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.98||||0.0001|TWO_SIDED|95.0|2.81|12.76|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Statin Medication||12.76|2.81|0.0001
71811136|NCT01515748|143124219|SUPERIORITY|||||||0.0152||||||Threshold for statistical significance at 0.049.|Stratified Log Rank|||Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).||||0.0152
71811137|NCT00416182|143124229|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant|t-test, 2 sided|||||||0.2
71811138|NCT00416182|143124230|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|95.0||||P-value of \< 0.05 is considered significant.|t-test, 2 sided|||||||0.048
71811139|NCT00416182|143124231|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0||||P-value \< 0.05 is considered significant|t-test, 2 sided|||||||0.003
71811140|NCT00416182|143124232|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P \<0.05 is considered significant|t-test, 2 sided|||||||0.4
71811141|NCT04102579|143124256|OTHER||Least Squares (LS) Means Difference|-3.16|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-4.37|-1.95||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|Results were analyzed using a mixed-effect model repeated measures (MMRM) analysis. The model included the screening period baseline TMC as a covariate, and treatment group, visit, treatment group-by-visit interaction, and baseline-by-visit interaction as fixed effects. Participant was included as a random effect.||-1.95|-4.37|<0.0001
71844138|NCT02307682|143202439|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|1.4|13.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||13.8|1.4|
71844139|NCT02307682|143202440|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.3|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.9|-4.3|
71844140|NCT02307682|143202440|OTHER||Difference in proportions|6.3|||||TWO_SIDED|95.0|0.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||12.2|0.6|
71676648|NCT00355147|142871195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0004|TWO_SIDED|95.0|1.83|8.01|||Regression, Logistic|||Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.||8.01|1.83|0.0004
71676649|NCT00355147|142871196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.096|TWO_SIDED|95.0|0.86|6.4|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Hypertension Medication||6.40|0.86|0.096
71844141|NCT02307682|143202440|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.6|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.7|-6.6|
71844142|NCT02307682|143202440|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||8.0|-4.7|
71844143|NCT02307682|143202440|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.2|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.1|-6.2|
71844144|NCT02307682|143202440|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||12.7|-0.8|
71844145|NCT02307682|143202440|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.0|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||7.7|-6.0|
71844146|NCT02307682|143202440|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.5|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||12.2|-1.5|
71844147|NCT02307682|143202440|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-6.5|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.0|-6.5|
71844148|NCT02307682|143202440|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.8|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.2|-1.8|
71844149|NCT02307682|143202440|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.0|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||9.5|-4.0|
71844150|NCT02307682|143202440|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-3.5|11.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||11.3|-3.5|
71844151|NCT02307682|143202440|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.9|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.2|-5.9|
71844152|NCT02307682|143202440|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.4|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||11.2|-3.4|
71895499|NCT02723630|143313587|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|100.52||||0.8826|TWO_SIDED|90.0|94.84|106.53||P-value for the formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.53|94.84|0.8826
71895500|NCT02723630|143313587|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.03||||0.1095|TWO_SIDED|90.0|92.11|100.12||P-value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.12|92.11|0.1095
71676650|NCT00355147|142871196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.68||||0.0004|TWO_SIDED|95.0|1.81|7.48|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Hypertension Medication||7.48|1.81|0.0004
71676651|NCT00355147|142871196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.21|TWO_SIDED|95.0|0.77|3.21|||Regression, Logistic|||Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.||3.21|0.77|0.21
71811142|NCT04102579|143124257|OTHER||Percent Difference in Responders|29.65||||0.0007|TWO_SIDED|95.0|10.77|45.37||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||45.37|10.77|0.0007
71811143|NCT04102579|143124258|OTHER||Percent Difference in Responders|26.31||||0.0062|TWO_SIDED|95.0|6.32|43.74||Statistical significance achieved if p-value \<0.05.|Fisher Exact||Percent Difference in Responders (%) = Valbenazine - Placebo|||43.74|6.32|0.0062
71811144|NCT04102579|143124259|OTHER||LS Means Difference|1.42|STANDARD_ERROR_OF_MEAN|1.46||0.3304|TWO_SIDED|95.0|-1.46|4.31||Statistical significance achieved if p-value \<0.05.|MMRM||LS Means Difference = Valbenazine - Placebo|LS mean was based on the MMRM model which included corresponding baseline value of the Neuro-QoL Upper Extremity Function T-score as a covariate; treatment group, visit, baseline-by-visit interaction, and treatment group-by-visit interaction as fixed effects; and participant as a random effect.||4.31|-1.46|0.3304
71811145|NCT01077830|143124277|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.84|2.09|||Regression, Cox||Hazard Ratio obtained by dividing the crude rate of death (any cause) reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death (any cause) in the Placebo arm|||2.09|0.84|
71811146|NCT01077830|143124278|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|0.3|6.06|||||Hazard Ratio obtained by dividing the crude rate of death from cancer reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death from cancer in the Placebo arm|||6.06|0.30|
71811147|NCT01077830|143124279|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.55|||||TWO_SIDED|95.0|0.27|1.11|||||Hazard Ratio obtained by dividing the crude rate of new cancers reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of newly diagnosed cancers in the the Placebo arm|||1.11|0.27|
71811148|NCT01194570|143124282|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|29.337||||0.0404|TWO_SIDED|95.0|-1.618|51.456||P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL 25-FTW)\*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.||51.456|-1.618|0.0404
71811149|NCT01194570|143124283|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Geometric Means|0.9|||<|0.0001|TWO_SIDED|95.0|0.876|0.924||P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (\<=45, \> 45 years); missing observations imputed with LOCF.|Ranked ANCOVA|||Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + log (BL T2 lesion volume)\*Week.||0.924|0.876|< 0.0001
71811150|NCT01194570|143124284|SUPERIORITY_OR_OTHER_LEGACY||Relative Reduction (%)|17.475||||0.0206|TWO_SIDED|95.0|3.206|29.251|||MMRM||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Brain Volume at Week 24\*Week. Relative reduction was calculated as - Relative change = - (OCR response-Placebo response)/Placebo response\*100%. The 95% CI for relative reduction was obtained using Bootstrap method.||29.251|3.206|0.0206
71811151|NCT01194570|143124285|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.377|STANDARD_ERROR_OF_MEAN|0.725||0.6034|TWO_SIDED|95.0|-1.048|1.802|||MMRM||Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (\<=45, \> 45 years) + Week + Treatment + Treatment\*Week (repeated values over Week) + Baseline PCS Score\*Week.||1.802|-1.048|0.6034
71811152|NCT01337674|143124288|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.22|||||TWO_SIDED|90.0|-8.42|5.98|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||5.98|-8.42|
71811153|NCT01337674|143124288|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|2.29|||||TWO_SIDED|90.0|-4.92|9.49|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||9.49|-4.92|
71811154|NCT01337674|143124288|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|1.65|||||TWO_SIDED|90.0|-5.31|8.62|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||8.62|-5.31|
71811155|NCT01337674|143124288|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is \<20 mmHg|Mean Difference (Final Values)|-1.09|||||TWO_SIDED|90.0|-8.06|5.88|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||5.88|-8.06|
71676652|NCT03514485|142871207|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.34|0.25||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.25|-0.34|
71676653|NCT03514485|142871207|SUPERIORITY||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.34|0.18||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.18|-0.34|
71676654|NCT03514485|142871207|SUPERIORITY||Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.48|0.04||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.04|-0.48|
71811156|NCT01337674|143124289|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|1.95|||||TWO_SIDED|90.0|-2.85|6.75|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1||6.75|-2.85|
71811157|NCT01337674|143124289|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-5.91|||||TWO_SIDED|90.0|-10.71|-1.11|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7||-1.11|-10.71|
71811158|NCT01337674|143124289|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-6.25|||||TWO_SIDED|90.0|-11.47|-1.03|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1||-1.03|-11.47|
71811159|NCT01337674|143124289|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is \<20 mmHg|Mean Difference (Final Values)|-1.57|||||TWO_SIDED|90.0|-6.79|3.65|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7||3.65|-6.79|
71811160|NCT02673398|143124298|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.05|TWO_SIDED|95.0|-0.82|0.01|||t-test, 2 sided||Patients with higher risk scores were more likely to require a dose reduction. The lack of significance is most likely due to the small sample size.|Student's t-test was used to assess if geriatric risk score differed depending on whether or not a participant had a dose reduction (mean difference log2 risk = no dose modification - dose modification).||0.01|-0.82|0.05
71811161|NCT02673398|143124298|SUPERIORITY||Slope|-1.29|STANDARD_ERROR_OF_MEAN|1.44||0.39|TWO_SIDED||||||Regression, Linear|||Linear regression was used to assess whether log2 geriatric toxicity risk score was a risk factor for the number of course completed.||||0.39
71811162|NCT02673398|143124299|SUPERIORITY||Slope|-0.093|STANDARD_ERROR_OF_MEAN|0.0398||0.03|TWO_SIDED||||||Regression, Linear||The older the participant the lower the steady state value.|Least squares regression was used to assess the relationship between steady state neratinib concentration and age||||0.03
71811163|NCT02673398|143124299|SUPERIORITY||Slope|1.4|STANDARD_DEVIATION|2.39||0.57|TWO_SIDED||||||Regression, Linear||Geriatric risk score was not predictive of steady state concentration.|Least squares regression was used to determine if geriatric toxicity risk score at baseline was predictive of steady state neratinib concentration.||||0.57
71811164|NCT01224925|143124311|SUPERIORITY||Log Rank (Mantel-Cox)|842.0|||<|0.01|TWO_SIDED|95.0|693.0|991.0|||Log Rank|||The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.||991|693|<0.01
71811165|NCT01224925|143124311|SUPERIORITY||Log Rank (Mantel-Cox)|1201.0|||<|0.01|TWO_SIDED|95.0|1068.0|1335.0|||Log Rank|||||1335|1068|<0.01
71811166|NCT01224925|143124312|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71811167|NCT02178059|143124323|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|88.2|||||TWO_SIDED|90.0|81.03|96.02|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||96.02|81.03|
71811168|NCT02178059|143124324|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8052|TWO_SIDED|90.0|-0.17|0.17|||Wilcoxon signed rank test|||||0.17|-0.17|0.8052
71844153|NCT02307682|143202440|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-8.2|
71676655|NCT03514485|142871207|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|95.0|-0.44|0.9||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.9|-0.44|
71676656|NCT03514485|142871207|SUPERIORITY||Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.36|0.09||||||Linear mixed effects models were then used to make the comparisons of all combinations of primary care and school-based interventions with respect to Asthma Control. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the COVID-19 pandemic.||0.09|-0.36|
71811169|NCT02178059|143124328|NON_INFERIORITY_OR_EQUIVALENCE|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are \<1.25 provided that the true mean ratios are \<1.05.|Ratio of geometric means (%)|91.44|||||TWO_SIDED|90.0|84.82|98.58|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25||98.58|84.82|
71811170|NCT03675451|143124344|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|0.95|||||TWO_SIDED|95.0|0.74|0.99|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||0.99|0.74|
71676657|NCT03514485|142871208|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.39|0.55||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.55|-0.39|
71676658|NCT03514485|142871208|SUPERIORITY||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|0.04|0.88||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.88|0.04|
71676659|NCT03514485|142871208|SUPERIORITY||Mean Difference (Net)|-0.65|||||TWO_SIDED|95.0|-1.06|-0.23||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.23|-1.06|
71811171|NCT03675451|143124345|OTHER|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Proportion of Participants|1.0|||||TWO_SIDED|95.0|0.66|1.0|||||Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.|Clopper-Pearson (Exact) 95% confidence interval to assess precision of finding.||1.00|0.66|
71811172|NCT04098406|143124357|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.4304|TWO_SIDED|95.0|-11.9|27.3|||MMRM|||||27.3|-11.9|0.4304
71811173|NCT04098406|143124358|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.6519|TWO_SIDED|95.0|-12.4|19.7|||MMRM|||||19.7|-12.4|0.6519
71811174|NCT04098406|143124359|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.6158|TWO_SIDED|95.0|-56.4|94.0|||MMRM|||||94.0|-56.4|0.6158
71811175|NCT04098406|143124364|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.4249|TWO_SIDED|95.0|-1.6|3.6|||MMRM|||||3.6|-1.6|0.4249
71811176|NCT04098406|143124365|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.0350
71811177|NCT04098406|143124367|SUPERIORITY||Mean Difference (Final Values)|9.1||||0.2237|TWO_SIDED|95.0|-5.8|23.9|||ANCOVA|||||23.9|-5.8|0.2237
71811178|NCT04098406|143124368|SUPERIORITY||Hazard Ratio (HR)|0.29||||0.0125|TWO_SIDED|95.0|0.103|0.815|||Log Rank|||||0.815|0.103|0.0125
71811179|NCT04098406|143124370|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0177|TWO_SIDED|95.0|0.2|1.6|||MMRM|||||1.6|0.2|0.0177
71811180|NCT01783418|143124374|SUPERIORITY_OR_OTHER|||||||0.613|TWO_SIDED||||||ANOVA|||Baseline and Post-intervention (8 weeks)||||0.613
71811181|NCT01783418|143124375|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.957
71811182|NCT01783418|143124376|SUPERIORITY_OR_OTHER|||||||0.256|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||.256
71811183|NCT01783418|143124377|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.97
71811184|NCT01783418|143124378|SUPERIORITY_OR_OTHER|||||||0.241|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention||||0.241
71811185|NCT01783418|143124379|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.358
71811186|NCT01783418|143124380|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||Baseline, Post-intervention (8 weeks)||||0.95
71811187|NCT04791761|143124381|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Null hypothesis: No difference in average pain scores before medication between opioid and non-opioid groups.||||0.8
71811188|NCT04791761|143124381|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference in average pain scores after medication between opioid and non-opioid groups.||||0.7
71811189|NCT04791761|143124382|SUPERIORITY|||||||0.2|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care post-operatively between opioid and non-opioid groups.||||0.2
71844154|NCT02307682|143202440|OTHER||Difference in proportions|3.6|||||TWO_SIDED|95.0|-3.2|10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.5|-3.2|
71844155|NCT02307682|143202440|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.3|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-7.3|
71844156|NCT02307682|143202440|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.2|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.6|-5.2|
71844157|NCT02307682|143202440|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.6|-7.8|
71844158|NCT02307682|143202440|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.8|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||10.0|-4.8|
71844159|NCT02307682|143202440|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.4|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.2|-4.4|
71844160|NCT02307682|143202440|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-7.1|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.2|-7.1|
71844161|NCT02307682|143202440|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.9|
71844162|NCT02307682|143202440|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||9.2|-4.5|
71844163|NCT02307682|143202440|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.8|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-6.8|
71844164|NCT02307682|143202440|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.4|-5.8|
71844165|NCT02307682|143202440|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-6.1|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.2|-6.1|
71844166|NCT02307682|143202440|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.6|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.6|-8.6|
71844167|NCT02307682|143202440|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.0|7.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||7.1|-7.0|
71844168|NCT02307682|143202440|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.5|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||11.0|-3.5|
71844169|NCT02307682|143202440|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-3.0|10.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||10.8|-3.0|
71844170|NCT02307682|143202440|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|-1.4|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||13.0|-1.4|
71895501|NCT02723630|143313588|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.8||||0.8121|TWO_SIDED|90.0|95.31|106.61||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.61|95.31|0.8121
71895502|NCT02723630|143313588|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|96.51||||0.163|TWO_SIDED|90.0|92.53|100.65||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||100.65|92.53|0.1630
71895503|NCT02723630|143313589|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|99.68||||0.9427|TWO_SIDED|90.0|92.45|107.47||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||107.47|92.45|0.9427
71895504|NCT02723630|143313589|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|93.5||||0.0403|TWO_SIDED|90.0|88.63|98.64||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.64|88.63|0.0403
71895505|NCT02723630|143313590|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|100.29||||0.9373|TWO_SIDED|90.0|94.37|106.58||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||106.58|94.37|0.9373
71844171|NCT02307682|143202440|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-4.1|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.5|-4.1|
71895506|NCT02723630|143313590|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|95.17||||0.0682|TWO_SIDED|90.0|91.03|99.5||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||99.50|91.03|0.0682
71895507|NCT02723630|143313591|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|98.73||||0.8448|TWO_SIDED|90.0|88.57|110.06||P value for formulation|Mixed Models Analysis||Geometric Least Squares Mean Ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||110.06|88.57|0.8448
71895508|NCT02723630|143313591|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|90.64||||0.0498|TWO_SIDED|90.0|83.51|98.38||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.||98.38|83.51|0.0498
71895509|NCT00995371|143313651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52|||<|0.05|TWO_SIDED|95.0|1.09|3.96|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.96|1.09|<0.05
71895510|NCT00995371|143313651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|||>|0.05|TWO_SIDED|95.0|-1.43|1.55|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||1.55|-1.43|>0.05
71676660|NCT03514485|142871208|SUPERIORITY||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-1.39|-0.67||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.67|-1.39|
71844172|NCT02307682|143202440|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||9.7|-4.8|
71895511|NCT00995371|143313652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.33|||<|0.05|TWO_SIDED|95.0|3.35|19.31|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||19.31|3.35|<0.05
71895512|NCT00995371|143313652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.65|||>|0.05||95.0|-4.12|15.41|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||15.41|-4.12|>0.05
71811190|NCT00415610|143124431|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.|repeated measure|Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score \> 8.||The hourly average (of maximum and minimum) SBP measurements were graphed with box-and-whiskers plot. In addition, a repeated measures analysis of the 25 average SBP (baseline and subsequent 24 hourly measures) was conducted with a mixed effects model (assuming autoregressive covariance structure in SAS version 9.1 PROC MIXED) to determine statistically the effect of treatment intensity (tier) on the average SBP over the 24 hrs with and without adjustment for baseline NIHSS score and age.||||< 0.01
71811191|NCT00415610|143124432|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED|||||Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.|Wilcoxon rank sum test|Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.||Done as a surrogate to evaluate the relationship between early SBP reduction and safety events.||||< .5
71811192|NCT02563002|143124538|OTHER||Hazard Ratio (HR)|0.59||||0.0001|TWO_SIDED|95.0|0.45|0.79|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||0.79|0.45|0.0001
71811193|NCT02563002|143124539|OTHER||Hazard Ratio (HR)|0.74||||0.0359|TWO_SIDED|95.0|0.53|1.03|||Log Rank|One-sided p-value based on log rank test|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.03|0.53|0.0359
71811194|NCT02563002|143124540|OTHER||Difference in percentage|12.0||||0.0159|TWO_SIDED|95.0|1.0|22.6||One-sided p-value based on Miettinen \& Nurminen method.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method.|||22.6|1.0|0.0159
71811195|NCT01113502|143124559|OTHER||Maximum Tolerated Dose (mg)|300.0|||||TWO_SIDED|||||||||||||
71811196|NCT00995501|143124565|SUPERIORITY||Odds Ratio (OR)|0.96||||0.86|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2|0.45|0.86
71811197|NCT00995501|143124565|SUPERIORITY||Odds Ratio (OR)|0.96||||0.87|TWO_SIDED|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2|0.45|0.87
71811198|NCT00995501|143124565|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|99.6|0.49|2.2|||Regression, Logistic|||Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia||2.2|0.49|0.90
71811199|NCT00995501|143124566|SUPERIORITY||Odds Ratio (OR)|0.92||||0.8|TWO_SIDED|99.6|0.37|2.3|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control||2.3|0.37|0.8
71811200|NCT00995501|143124566|SUPERIORITY||Odds Ratio (OR)|1.1||||0.84|TWO_SIDED|99.6|0.43|2.7|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo||2.7|0.43|0.84
71811201|NCT00995501|143124566|SUPERIORITY||Odds Ratio (OR)|1.1||||0.87|TWO_SIDED|99.6|0.42|2.7|||Regression, Logistic|||||2.7|0.42|0.87
71811202|NCT03574597|143124590|SUPERIORITY||Hazard Ratio (HR)|0.8|||<|0.0001|TWO_SIDED|95.0|0.72|0.89|||Regression, Cox|||Data from the in-trial period. The outcome measure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Participants without events of interest were censored at the end of their in-trial period.||0.89|0.72|< 0.0001
71811203|NCT06060457|143124631|OTHER||Geometric Mean Ratio (GMR)|0.625|||||TWO_SIDED|95.0|0.57|0.686||||||RSV-A: Arm 1 versus Arm 2||0.686|0.570|
71811204|NCT06060457|143124631|OTHER||GMR|0.638|||||TWO_SIDED|95.0|0.584|0.697||||||RSV-B: Arm 1 versus Arm 2||0.697|0.584|
71811205|NCT01338025|143124669|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Log Rank|||||||0.03
71811206|NCT00838682|143124718|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71811207|NCT00838682|143124719|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71811208|NCT00838682|143124720|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71811209|NCT00838682|143124721|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71811210|NCT00838682|143124722|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71811211|NCT00838682|143124723|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71811212|NCT03315143|143124734|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Cox proportional hazards model|||The estimates of the hazard ratio (HR) and corresponding 2-sided 95% confidence interval (CI) was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-cardiovascular (non-CV) death treated as a competing event.||0.88|0.63|<0.001
71811213|NCT03315143|143124735|SUPERIORITY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.55|0.82|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.82|0.55|<0.001
71811214|NCT03315143|143124736|SUPERIORITY||Hazard Ratio (HR)|0.9|||=|0.35|TWO_SIDED|95.0|0.73|1.12|||Cox proportional hazards model|||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.12|0.73|=0.35
71811215|NCT03315143|143124737|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.63|0.83||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.83|0.63|
71811216|NCT03315143|143124738|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.89|0.65|
71811217|NCT03315143|143124739|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.46|1.08||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||1.08|0.46|
71811218|NCT03315143|143124740|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.83|1.18||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction.||1.18|0.83|
71895513|NCT00995371|143313653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.19|||<|0.05||95.0|0.61|3.77|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||3.77|0.61|<0.05
71895514|NCT00995371|143313653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||>|0.05||95.0|-0.66|2.66|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||2.66|-0.66|>0.05
71895515|NCT00995371|143313654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.13|||<|0.05||95.0|7.43|24.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||24.83|7.43|<0.05
71895516|NCT00995371|143313654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.17|||>|0.05||95.0|-1.24|13.58|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.||13.58|-1.24|>0.05
71895517|NCT00144300|143313663|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||||95.0|0.71|1.6||||||||1.60|0.71|
71895518|NCT02273973|143313700|SUPERIORITY||Difference in Response Rates|10.71||||0.049|TWO_SIDED|95.0|0.11|21.32|||Cochran-Mantel-Haenszel|||||21.32|0.11|0.0490
71895519|NCT02273973|143313701|SUPERIORITY||Difference in Response Rates|1.21||||0.3698|TWO_SIDED|95.0|-1.12|3.55|||Fisher Exact|||||3.55|-1.12|0.3698
71895520|NCT02273973|143313702|SUPERIORITY||Difference in Response Rates|18.19||||0.0332|TWO_SIDED|95.0|2.57|33.81|||Cochran-Mantel-Haenszel|||||33.81|2.57|0.0332
71895521|NCT02273973|143313703|SUPERIORITY||Difference in Response Rates|1.37||||0.4803|TWO_SIDED|95.0|-1.3|4.04|||Fisher Exact|||||4.04|-1.30|0.4803
71895522|NCT02273973|143313704|SUPERIORITY||Difference in Response Rates|5.2||||0.5017|TWO_SIDED|95.0|-9.2|19.61|||Cochran-Mantel-Haenszel|||||19.61|-9.20|0.5017
71895523|NCT02273973|143313705|SUPERIORITY||Difference in Response Rates|1.05||||1|TWO_SIDED|95.0|-2.65|4.75|||Fisher Exact|||||4.75|-2.65|1.0000
71811219|NCT03315143|143124741|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.65|0.91||||||The estimates of the HR and corresponding 2-sided 95% CI was to be provided by a marginal Cox proportional hazard model stratified by region and ejection fraction, with non-CV death treated as a competing event.||0.91|0.65|
71811220|NCT00939874|143124771|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71895524|NCT02273973|143313706|SUPERIORITY||Difference in Response Rates|21.14||||0.0115|TWO_SIDED|95.0|5.59|36.68|||Cochran-Mantel-Haenszel|||||36.68|5.59|0.0115
71895525|NCT02273973|143313707|SUPERIORITY||Difference in Response Rates|2.66||||0.7928|TWO_SIDED|95.0|-11.88|17.2|||Cochran-Mantel-Haenszel|||||17.20|-11.88|0.7928
71811221|NCT00834106|143124795|SUPERIORITY_OR_OTHER||Vaccine efficacy|76.0|||||TWO_SIDED|95.0|43.7|91.1|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||91.1|43.7|
71811222|NCT00834106|143124796|SUPERIORITY_OR_OTHER||Vaccine efficacy|82.3|||||TWO_SIDED|95.0|38.3|96.7|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||96.7|38.3|
71811223|NCT00834106|143124797|SUPERIORITY_OR_OTHER||Vaccine efficacy|100.0||||0.0072|TWO_SIDED|95.0|32.3|100.0|||Exact test, 1-sided||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.|||100|32.3|0.0072
71811224|NCT00834106|143124803|SUPERIORITY_OR_OTHER||Vaccine efficacy|91.8|||||TWO_SIDED|95.0|79.8|97.4|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||97.4|79.8|
71811225|NCT00834106|143124804|SUPERIORITY_OR_OTHER||Vaccine efficacy|93.2|||||TWO_SIDED|95.0|72.9|99.2|||||Vaccine efficacy = 100 \* \[1 - (incidence rate with V501 / incidence rate with placebo)\].|||99.2|72.9|
71895526|NCT02273973|143313708|SUPERIORITY||Difference in Response Rates|9.45||||0.2659|TWO_SIDED|95.0|-5.8|24.7|||Cochran-Mantel-Haenszel|||||24.70|-5.80|0.2659
71895527|NCT02273973|143313709|SUPERIORITY||Difference in Response Rates|7.63||||0.3299|TWO_SIDED|95.0|-6.34|21.6|||Cochran-Mantel-Haenszel|||||21.60|-6.34|0.3299
71895528|NCT02273973|143313710|SUPERIORITY||Difference in Response Rates|10.68||||0.1554|TWO_SIDED|95.0|-3.96|25.32|||Cochran-Mantel-Haenszel|||||25.32|-3.96|0.1554
71895529|NCT02273973|143313711|SUPERIORITY||Difference in Response Rates|2.41||||0.787|TWO_SIDED|95.0|-11.82|16.63|||Cochran-Mantel-Haenszel|||||16.63|-11.82|0.7870
71895530|NCT02273973|143313712|SUPERIORITY||Ratio of Least square mean|0.83||||0.117|TWO_SIDED|95.0|0.65|1.05|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Week 3.||1.05|0.65|0.117
71895531|NCT02273973|143313712|SUPERIORITY||Ratio of Least square mean|1.25||||0.105|TWO_SIDED|95.0|0.95|1.65|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Surgery.||1.65|0.95|0.105
71895532|NCT02273973|143313714|SUPERIORITY||Least squares mean difference|-13.32||||0.002|TWO_SIDED|95.0|-21.67|-4.96|||Regression, Linear|||||-4.96|-21.67|0.002
71895533|NCT02209597|143313720|SUPERIORITY||||||<|0.05|ONE_SIDED|90.0|||||ANOVA|||||||<0.05
71895534|NCT03726671|143313724|OTHER|||||||0.0247|||||||Repeated measures ANOVA|||Betaine IER||||0.0247
71895535|NCT03726671|143313724|OTHER||||||<|0.0001|||||||Repeated measures ANOVA|||Choline IER||||<0.0001
71895536|NCT03726671|143313724|OTHER|||||||0.0002|||||||Repeated measures ANOVA|||Phosphatidylcholine IER||||0.0002
71895537|NCT03726671|143313725|OTHER||Odds Ratio (OR)|7.16|||<|0.001|TWO_SIDED|95.0|3.48|14.7|||Fisher Exact|||||14.7|3.48|<0.001
71895538|NCT03726671|143313725|OTHER||Odds Ratio (OR)|4.09||||0.01|TWO_SIDED|95.0|2.06|8.11|||Fisher Exact|||||8.11|2.06|0.01
71895539|NCT03726671|143313725|OTHER||Odds Ratio (OR)|1.75||||0.086|TWO_SIDED|95.0|0.86|3.58|||Fisher Exact|||||3.58|0.86|0.086
71895540|NCT03726671|143313726|OTHER|||||||0.6985|||||||t-test, 2 sided|||Betaine IER||||0.6985
71895541|NCT03726671|143313726|OTHER|||||||0.035|||||||t-test, 2 sided|||Choline IER||||0.0350
71895542|NCT03726671|143313726|OTHER|||||||0.6864|||||||t-test, 2 sided|||Phosphatidylcholine IER||||0.6864
71811226|NCT02436811|143124805|SUPERIORITY_OR_OTHER||||||<|0.001||||||A stepwise forward selection model was used. All independent variables with P\<0.20 in the univariate analysis were selected and those which were significant (P\<0.05) were kept in the final model. The level of significance was 5%.|Regression, Poisson|||Univariate and multivariate Poisson regressions with robust variance were obtained to estimate the rate ratios (RR) and their respective 95% confidence intervals. Two Poisson regression models were generated, using the knowledge score 15 minutes after the intervention (post-test) and 4 weeks after the interventions (follow-up test) as dependent variables.||||<0.001
71811227|NCT03595332|143124806|EQUIVALENCE|The analysis tests whether for both groups combined, the baseline to 10-week follow-up BMI percentile scores are significantly different from zero.|Mean Difference (Final Values)|1.137|STANDARD_ERROR_OF_MEAN|0.9846||0.248|TWO_SIDED|95.0|-0.793|3.067||This test compares baseline to 10-week post-test for both groups combined, to test the null hypothesis that the BMI Percentile score would not be different from zero. A p-value of 0.05 was used as a priori threshold for statistical significance.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of 222 children nested within 150 families and 4 schools.||||3.067|-0.793|0.248
71811228|NCT03595332|143124807|EQUIVALENCE|Analysis tested whether BMI Percentile score change among overweight participants (BMI equal or greater than 85th percentile at baseline) significantly changed from baseline to follow-up (was significantly different from zero). This was a subset analysis among the highest risk participants in the study.|Mean Difference (Final Values)|-3.173|STANDARD_ERROR_OF_MEAN|1.34||0.018|TWO_SIDED|95.0|-5.806|-0.541||The p-value threshold was 0.05 for all comparisons.|Regression, Linear|Linear regression with Generalized Estimating Equations to account for nested data structure of children within schools and families.|A negative parameter suggests a decreased BMI Percentile.|||-0.541|-5.806|0.018
71811229|NCT03595332|143124808|EQUIVALENCE|Analysis tested the difference in BMI percentile between baseline and 1-year follow-up among participants in the immediate intervention group to test the null hypothesis that no change occurred.|Mean Difference (Final Values)|0.363|STANDARD_ERROR_OF_MEAN|1.676||0.829|TWO_SIDED|95.0|-2.922|3.648||A prior threshold for statistical significance was 0.05. No adjustment for multiple comparisons was made.|Regression, Linear|Analysis included Generalized Estimating Equations with linear response variable, accounting for nested data structure.||||3.648|-2.922|0.829
71811230|NCT03595332|143124809|EQUIVALENCE|Analysis test whether for both groups combined, Baseline to 10-week change in reported intention of physical activity was significantly different from zero.|Mean Difference (Final Values)|0.284|STANDARD_ERROR_OF_MEAN|0.128||0.026|TWO_SIDED|95.0|0.034|0.534||A priori threshold for statistical significance is 0.05. No adjustments for multiple comparisons were made.|Regression, Linear|Linear regression models with Generalized Estimating Equations to account for nested data were made.|A positive parameter would suggest an increase in intentions to be physically active.|||0.534|0.034|0.026
71811231|NCT02227875|143124810|NON_INFERIORITY|Mixed-Effect Model for Repeated Measures|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.098|0.218||||||||0.218|-0.098|
71811232|NCT00117676|143124833|NON_INFERIORITY_OR_EQUIVALENCE|With a sample size of 200 subjects in the tenofovir DF group and 100 subjects in the adefovir dipivoxil group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the tenofovir DF treatment was inferior to the adefovir dipivoxil treatment (difference in proportions was less than -0.100) in favor of the alternative hypothesis that the tenofovir DF treatment was not inferior.|Difference in proportions|23.5|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|13.2|33.8||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≥ 2 x ULN or \> 2 x ULN) difference is 0.|Z-test|||A two-sided 95% confidence interval (CI), stratified by baseline ALT (≤ 2 x ULN or \> 2 x ULN) was used to evaluate the difference (tenofovir DF - adefovir dipivoxil) in the proportion of complete responders between treatment groups.||33.8|13.2|<0.001
71811233|NCT00117676|143124834|SUPERIORITY_OR_OTHER||Difference in proportions|30.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|21.3|39.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 2 x ULN or \> 2 x ULN).|Z-test|||||39.2|21.3|<0.001
71895543|NCT03726671|143313727|EQUIVALENCE|There are linear combinations of metabolites that differentiate (non-equivalent) the 25% choline diet from the 100% choline diet.|||||<|0.049|||||||Paired 2-sided t-test||||Supervised OPLSDA was used to determine the variable importance to projections of metabolites/signals that differentiated the 25% and 100% choline diet arms.|||<0.049
71895544|NCT03726671|143313728|OTHER|||||||0.9567|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Pre-Menopausal Females||||0.9567
71811234|NCT00117676|143124835|SUPERIORITY_OR_OTHER||Difference in proportions|1.4|STANDARD_ERROR_OF_MEAN|3.4||0.672|TWO_SIDED|95.0|-5.2|8.0||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Two-sided 95% confidence intervals, stratified by baseline ALT (baseline ALT ≤ 2 x ULN, \> 2 x ULN), were used to evaluate treatment arm differences.|Z-test|||||8.0|-5.2|0.672
71811235|NCT00117676|143124840|SUPERIORITY_OR_OTHER||Difference in proportions|5.2|STANDARD_ERROR_OF_MEAN|5.0||0.293|TWO_SIDED|95.0|-4.5|14.9||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Confidence interval stratum adjusted based on baseline ALT (≤ 2 x ULN, \> 2 x ULN).|Z-test|||||14.9|-4.5|0.293
71811236|NCT00117676|143124846|SUPERIORITY_OR_OTHER||Difference in proportions|-0.8|STANDARD_ERROR_OF_MEAN|4.8||0.859|TWO_SIDED|95.0|-10.2|8.5||Statistical tests were not adjusted for baseline ALT stratum. Analysis set included only randomized and treated participants with baseline ALT \> ULN (biochemically evaluable analysis set).|Z-test|P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.||||8.5|-10.2|0.859
71895545|NCT03726671|143313728|OTHER|||||||0.0899|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Post-Menopausal Females||||0.0899
71895546|NCT03726671|143313728|OTHER|||||||0.9003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Betaine IER in Males||||0.9003
71895547|NCT03726671|143313728|OTHER|||||||0.9932|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Pre-Menopausal Females||||0.9932
71676661|NCT03514485|142871208|SUPERIORITY||Mean Difference (Net)|-0.57|||||TWO_SIDED|95.0|-0.95|-0.18||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Daytime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.18|-0.95|
71895548|NCT03726671|143313728|OTHER|||||||0.3984|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Post-Menopausal Females||||0.3984
71895549|NCT03726671|143313728|OTHER|||||||0.308|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Choline IER in Males||||0.3080
71895550|NCT03726671|143313728|OTHER|||||||0.7603|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.7603
71895551|NCT03726671|143313728|OTHER|||||||0.2995|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.2995
71895552|NCT03726671|143313728|OTHER|||||||0.0003|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||Diet x SNP interaction effect on Phosphatidylcholine IER in Males||||0.0003
71895553|NCT03726671|143313728|OTHER|||||||0.1303|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Pre-Menopausal Females||||0.1303
71676662|NCT03514485|142871209|SUPERIORITY||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.53|0.28||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.28|-0.53|
71676663|NCT03514485|142871209|SUPERIORITY||Median Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.45|0.26||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.45|
71676664|NCT03514485|142871209|SUPERIORITY||Mean Difference (Net)|-0.25|||||TWO_SIDED|95.0|-0.6|0.1||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.10|-0.60|
71895554|NCT03726671|143313728|OTHER|||||||0.0015|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Post-Menopausal Females||||0.0015
71895555|NCT03726671|143313728|OTHER|||||||0.4185|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Betaine IER in Males||||0.4185
71895556|NCT03726671|143313728|OTHER|||||||0.3464|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Pre-Menopausal Females||||0.3464
71895557|NCT03726671|143313728|OTHER|||||||0.0019|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Post-Menopausal Females||||0.0019
71895558|NCT03726671|143313728|OTHER|||||||0.2091|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Choline IER in Males||||0.2091
71895559|NCT03726671|143313728|OTHER|||||||0.8141|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Pre-Menopausal Females||||0.8141
71811237|NCT00117676|143124847|SUPERIORITY_OR_OTHER||Difference in proportions|4.9|STANDARD_ERROR_OF_MEAN|5.3||0.359|TWO_SIDED|95.0|-5.5|15.3||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and confidence interval are stratum adjusted (baseline ALT ≤ 2 x ULN or \> 2 x ULN).||||15.3|-5.5|0.359
71844173|NCT02307682|143202440|OTHER||Difference in proportions|5.2|||||TWO_SIDED|95.0|-1.6|12.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||12.3|-1.6|
71844174|NCT02307682|143202440|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-5.4|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.6|-5.4|
71844175|NCT02307682|143202440|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.8|9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.4|-4.8|
71811238|NCT00952822|143124865|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.052||||||90.0|-0.117|0.012||||||||0.012|-0.117|
71811239|NCT00952822|143124866|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.016||||||90.0|-0.076|0.043||||||||0.043|-0.076|
71811240|NCT01250990|143124880|SUPERIORITY_OR_OTHER|||||||0.8||||||p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.|t-test, 2 sided|||This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.||||0.8
71811241|NCT00406133|143124958|SUPERIORITY_OR_OTHER|||||||0.29||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age 8-14 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.||||0.29
71811242|NCT00406133|143124958|SUPERIORITY_OR_OTHER|||||||0.52||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value for age 15-24 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||0.52
71811243|NCT00406133|143124958|SUPERIORITY_OR_OTHER||||||<|0.001||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age \>=25 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||||||<0.001
71811244|NCT00406133|143124959|SUPERIORITY_OR_OTHER|||||||0.16||||||P-value was for the comparison of RT-CGM group and Control group.|ANCOVA|Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.||||0.16
71811245|NCT00406133|143124960|SUPERIORITY_OR_OTHER|||||||0.74||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
71811246|NCT00406133|143124960|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the 15-24 year age group.|Fisher Exact|||||||0.48
71811247|NCT00406133|143124960|SUPERIORITY_OR_OTHER|||||||1||||||P-value is for N(%) of subjects with \>=1 severe hypo event in the \>=25 year age group.|Fisher Exact|||||||1.0
71811248|NCT00406133|143124960|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.74
71844176|NCT02307682|143202440|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.0|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.2|-5.0|
71844177|NCT02307682|143202440|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||7.4|-6.9|
71844178|NCT02307682|143202440|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.1|8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.5|-5.1|
71676665|NCT03514485|142871209|SUPERIORITY||Median Difference (Net)|-0.28|||||TWO_SIDED|95.0|-0.57|0.01||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.01|-0.57|
71676666|NCT03514485|142871209|SUPERIORITY||Mean Difference (Net)|-0.38|||||TWO_SIDED|95.0|-0.72|-0.04||||||Mixed-effects generalized linear model with binomial family (n=14) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to Nighttime Symptoms. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.04|-0.72|
71811249|NCT00406133|143124960|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the 15-24 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||0.48
71811250|NCT00406133|143124960|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||P-value is for N(%) of subjects with \>=1 severe hypo event with seizure or comma in the \>=25 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher's exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.||||1.0
71811251|NCT00406133|143124961|SUPERIORITY_OR_OTHER|||||||0.53||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.53
71811252|NCT00406133|143124961|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
71811253|NCT00406133|143124961|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|||||||<0.001
71844179|NCT02307682|143202440|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-3.9|10.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||10.1|-3.9|
71844180|NCT02307682|143202440|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-5.0|9.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.1|-5.0|
71844181|NCT02307682|143202440|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.5|11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||11.8|-2.5|
71844182|NCT02307682|143202440|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.4|10.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||10.6|-3.4|
71844183|NCT02307682|143202440|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.6|12.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||12.2|-1.6|
71844184|NCT02307682|143202440|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-3.0|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.2|-3.0|
71844185|NCT02307682|143202440|OTHER||Difference in proportions|5.6|||||TWO_SIDED|95.0|-1.9|12.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.7|-1.9|
71844186|NCT02307682|143202440|OTHER||Difference in proportions|5.7|||||TWO_SIDED|95.0|-1.0|12.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||12.6|-1.0|
71811254|NCT00406133|143124962|SUPERIORITY_OR_OTHER|||||||0.58||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.58
71811255|NCT00406133|143124962|SUPERIORITY_OR_OTHER|||||||0.85||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.85
71811256|NCT00406133|143124962|SUPERIORITY_OR_OTHER|||||||0.002||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.002
71811257|NCT00406133|143124963|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.18
71811258|NCT00406133|143124963|SUPERIORITY_OR_OTHER|||||||0.44||||||P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.44
71811259|NCT00406133|143124963|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||<0.001
71811260|NCT00406133|143124964|SUPERIORITY_OR_OTHER|||||||0.29||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.29
71811261|NCT00406133|143124964|SUPERIORITY_OR_OTHER|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.79
71811262|NCT00406133|143124964|SUPERIORITY_OR_OTHER|||||||0.41||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.41
71811263|NCT00406133|143124965|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (\<=70 mg/dL and \<=50 mg/dL), hyperglycemic (\>180 mg/dL and \>250 mg/dL), and in the target range (71 to 180 mg/dL).||||0.50
71811264|NCT00406133|143124965|SUPERIORITY_OR_OTHER|||||||0.99||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.99
71811265|NCT00406133|143124965|SUPERIORITY_OR_OTHER|||||||0.1||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.10
71811266|NCT00406133|143124966|SUPERIORITY_OR_OTHER|||||||0.66||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Glucose variability was assessed by computing the absolute rate of change.||||0.66
71844187|NCT02307682|143202441|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.7|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.0|-7.7|
71811267|NCT00406133|143124966|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.48
71811268|NCT00406133|143124966|SUPERIORITY_OR_OTHER|||||||0.07||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for \>=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||||||0.07
71811269|NCT00406133|143124967|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|Adjusted for baseline A1c and clinical center.||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).||||<0.001
71811270|NCT00406133|143124968|SUPERIORITY_OR_OTHER||||||<|0.001||||||Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|ANCOVA|Adjusted for baseline value, clinical center and type of continuous glucose monitor.||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||<0.001
71811271|NCT00406133|143124969|SUPERIORITY_OR_OTHER|||||||0.03||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.03
71811272|NCT00406133|143124970|SUPERIORITY_OR_OTHER|||||||0.04||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.04
71811273|NCT00406133|143124970|SUPERIORITY_OR_OTHER|||||||0.46||||||P-value for the 15-24 year age group|Regression, Logistic|||||||0.46
71811274|NCT00406133|143124970|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value for the \>=25 year age group|Regression, Logistic|||||||0.003
71811275|NCT00406133|143124971|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value for 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.24
71811276|NCT00406133|143124971|SUPERIORITY_OR_OTHER|||||||0.98||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.98
71811277|NCT00406133|143124971|SUPERIORITY_OR_OTHER|||||||0.48||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.48
71811278|NCT00406133|143124972|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value representative of 13 and 26 weeks combined|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.005
71811279|NCT00406133|143124973|SUPERIORITY_OR_OTHER|||||||0.05||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||||0.05
71811280|NCT00406133|143124974|SUPERIORITY_OR_OTHER|||||||0.39||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Glucose variability was assessed by computing the absolute rate of change.||||0.39
71811281|NCT00406133|143124975|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Nominal p-value not adjusted for multiple comparisons|ANCOVA|||||||0.04
71811282|NCT00406133|143124976|SUPERIORITY_OR_OTHER||Ratio of treatment differences|408148.0|||||TWO_SIDED|95.0|-176644.0|3475108.0||||||"ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:~(mean cost\[CGM\] - mean cost \[control\]) / (mean QALY\[CGM\] - mean QALY\[SMBG\]).~Units are dollars per QALY."||3475108|-176644|
71811283|NCT00406133|143124977|SUPERIORITY_OR_OTHER|||||||0.009||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.009
71811284|NCT00406133|143124977|SUPERIORITY_OR_OTHER|||||||0.57||||||P-value for 15-24 year old age group|Regression, Logistic|||||||0.57
71811285|NCT00406133|143124977|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||<0.001
71811286|NCT00406133|143124978|SUPERIORITY_OR_OTHER|||||||0.18||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.18
71811287|NCT00406133|143124978|SUPERIORITY_OR_OTHER|||||||0.84||||||P-value for 15-24 year old age group.|Regression, Logistic|||||||0.84
71811288|NCT00406133|143124978|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for \>=25 year old age group.|Regression, Logistic|||||||0.02
71811289|NCT00406133|143124979|SUPERIORITY_OR_OTHER|||||||0.01||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by \>=10%, 26-week level \<7.0%, absolute decrease by \>=0.5%, relative increase by \>=10%, absolute increase by \>=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.01
71811290|NCT00406133|143124979|SUPERIORITY_OR_OTHER|||||||0.8||||||P-value for 14-24 year age group|Regression, Logistic|||||||0.80
71811291|NCT00406133|143124979|SUPERIORITY_OR_OTHER|||||||0.005||||||P-value for \>=25 year age group|Regression, Logistic|||||||0.005
71811292|NCT00406133|143124980|SUPERIORITY_OR_OTHER|||||||0.02||||||P-value for the 8-14 year age group|Regression, Logistic|||A post-hoc defined binary outcome of 26-week glycated hemoglobin \<7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.||||0.02
71811293|NCT00406133|143124980|SUPERIORITY_OR_OTHER|||||||0.67||||||P-value for the 15-24 year old age group|Regression, Logistic|||||||0.67
71811294|NCT00406133|143124980|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value for the \>=25 year old age group|Regression, Logistic|||||||0.006
71811295|NCT00406133|143124981|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
71811296|NCT00406133|143124982|SUPERIORITY_OR_OTHER|||||||0.002|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||0.002
71811297|NCT00406133|143124983|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by \>=0.3% and 26-week value \<7.0%) evaluated similarly using logistic regression models.||||<0.001
71811298|NCT03088267|143124993|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.0118|TWO_SIDED|95.0|-14.94|-2.17|||ANCOVA|||||-2.17|-14.94|0.0118
71811299|NCT03088267|143124994|SUPERIORITY||Mean Difference (Final Values)|18.8||||0.1128|TWO_SIDED|95.0|-4.94|42.5|||ANCOVA|||Comparison at 30 minutes post-dose||42.50|-4.94|0.1128
71811300|NCT03088267|143124994|SUPERIORITY||Mean Difference (Final Values)|60.3||||0.0003|TWO_SIDED|95.0|32.91|87.75|||ANCOVA|||Comparison at 3 hours postdose||87.75|32.91|0.0003
71811301|NCT01895972|143124995|OTHER||||||<|0.001||||||The reduction from baseline in IOP was significant at all post-baseline assessment time points through Week 52.|t-test, 2 sided|||comparison vs. baseline||||<0.001
71811302|NCT01800968|143125017|SUPERIORITY_OR_OTHER|||||||0.3087|||||||Rank score|||||||0.3087
71811303|NCT01800968|143125018|SUPERIORITY_OR_OTHER|||||||0.1549|||||||Regression, Linear|||||||0.1549
71811304|NCT01800968|143125019|SUPERIORITY_OR_OTHER|||||||0.1932|||||||Regression, Linear|||||||0.1932
71811305|NCT01800968|143125020|SUPERIORITY_OR_OTHER|||||||0.9535|||||||Regression, Linear|||||||0.9535
71811306|NCT01800968|143125021|SUPERIORITY_OR_OTHER|||||||0.8548|||||||Regression, Linear|||||||0.8548
71811307|NCT01800968|143125022|SUPERIORITY_OR_OTHER|||||||0.4266|||||||Regression, Linear|||||||0.4266
71811308|NCT01800968|143125023|SUPERIORITY_OR_OTHER|||||||0.1705|||||||Regression, Linear|||||||0.1705
71811309|NCT01800968|143125024|SUPERIORITY_OR_OTHER|||||||0.1309|||||||Regression, Linear|||||||0.1309
71811310|NCT01800968|143125025|SUPERIORITY_OR_OTHER|||||||0.792|||||||Regression, Linear|||||||0.7920
71811311|NCT01800968|143125026|SUPERIORITY_OR_OTHER|||||||0.7026|||||||Regression, Linear|||||||0.7026
71811312|NCT01800968|143125027|SUPERIORITY_OR_OTHER|||||||0.2662|||||||Regression, Linear|||||||0.2662
71811313|NCT01800968|143125028|SUPERIORITY_OR_OTHER|||||||0.6395|||||||Regression, Linear|||||||0.6395
71811314|NCT01800968|143125029|SUPERIORITY_OR_OTHER|||||||0.8218|||||||Regression, Linear|||||||0.8218
71811315|NCT01800968|143125030|SUPERIORITY_OR_OTHER|||||||0.1124|||||||Regression, Linear|||||||0.1124
71811316|NCT01800968|143125031|SUPERIORITY_OR_OTHER|||||||0.8088|||||||Regression, Linear|||||||0.8088
71811317|NCT01800968|143125032|SUPERIORITY_OR_OTHER|||||||0.7764|||||||Log Rank|||||||0.7764
71811318|NCT01800968|143125033|SUPERIORITY_OR_OTHER|||||||0.1701|||||||Log Rank|||||||0.1701
71811319|NCT01800968|143125034|SUPERIORITY_OR_OTHER|||||||0.6532|||||||Regression, Linear|||||||0.6532
71811320|NCT01800968|143125035|SUPERIORITY_OR_OTHER|||||||0.2033|||||||Rank score|||||||0.2033
71811321|NCT03266770|143125058|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.83|TWO_SIDED|95.0|-1.07|1.29|||t-test, 2 sided|||||1.29|-1.07|0.83
71811322|NCT05007392|143125077|SUPERIORITY||Difference of percentage|35.87|||<|0.001|TWO_SIDED|95.0|27.36|44.37|||Cochran-Mantel-Haenszel|P value based on a Cochran-Mantel-Haenszel test stratified by baseline SUA level and baseline body mass index (BMI) level.|The difference of percentage and stratified 95 percent (%) confidence interval (CI) was based on Mantel-Haenszel method.|||44.37|27.36|<0.001
71811323|NCT05007392|143125078|NON_INFERIORITY|The prespecified non-inferiority margin was -10% in the analysis.|Difference of percentage|5.24|||||TWO_SIDED|95.0|-3.69|14.17|||||The difference of percentage and stratified 95% CI was based on Mantel-Haenszel method.|||14.17|-3.69|
71811324|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.517|TWO_SIDED|95.0|-10.4|5.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4.||5.2|-10.4|0.517
71811325|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.763|TWO_SIDED|95.0|-8.9|6.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||6.5|-8.9|0.763
71811326|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.164|TWO_SIDED|95.0|-2.3|13.3|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||13.3|-2.3|0.164
71811327|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.9|TWO_SIDED|95.0|-9.2|10.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||10.5|-9.2|0.900
71811328|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.788|TWO_SIDED|95.0|-11.1|8.4|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||8.4|-11.1|0.788
71811329|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.722|TWO_SIDED|95.0|-8.2|11.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||11.8|-8.2|0.722
71811330|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7||||0.26|TWO_SIDED|95.0|-18.2|4.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||4.9|-18.2|0.260
71811331|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.422|TWO_SIDED|95.0|-16.1|6.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||6.8|-16.1|0.422
71811332|NCT01218126|143125091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.564|TWO_SIDED|95.0|-15.1|8.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||8.2|-15.1|0.564
71811333|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.968|TWO_SIDED|95.0|-39.0|38.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 4||38|-39|0.968
71811334|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.715|TWO_SIDED|95.0|-45.0|31.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 Placebo versus Losmapimod 7.5 mg at Week 4||31|-45|0.715
71811335|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.152|TWO_SIDED|95.0|-10.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||66|-10|0.152
71811336|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.922|TWO_SIDED|95.0|-45.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||40|-45|0.922
71811337|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.694|TWO_SIDED|95.0|-34.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-34|0.694
71811338|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.0||||0.094|TWO_SIDED|95.0|-6.3|79.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||79|-6.3|0.094
71811339|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.456|TWO_SIDED|95.0|-26.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||58|-26|0.456
71811340|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-22.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||61|-22|0.355
71811341|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.023|TWO_SIDED|95.0|6.7|91.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||91|6.7|0.023
71844188|NCT02307682|143202441|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.3|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||8.7|-5.3|
71844189|NCT02307682|143202441|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.4|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-7.4|
71844190|NCT02307682|143202441|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-8.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||5.3|-8.9|
71844191|NCT02307682|143202441|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.9|-8.1|
71676667|NCT03514485|142871210|SUPERIORITY||Mean Difference (Net)|2.38|||||TWO_SIDED|95.0|0.58|4.19||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||4.19|0.58|
71676668|NCT03514485|142871210|SUPERIORITY||Mean Difference (Net)|4.49|||||TWO_SIDED|95.0|2.54|6.43||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||6.43|2.54|
71676669|NCT03514485|142871210|SUPERIORITY||Mean Difference (Net)|-0.97|||||TWO_SIDED|95.0|-2.78|0.84||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.84|-2.78|
71811342|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.0||||0.32|TWO_SIDED|95.0|-21.0|65.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||65|-21|0.320
71811343|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.267|TWO_SIDED|95.0|-19.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||67|-19|0.267
71844192|NCT02307682|143202441|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.8|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||8.8|-4.8|
71844193|NCT02307682|143202441|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.7|-9.8|
71844194|NCT02307682|143202441|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-5.3|8.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||8.6|-5.3|
71844195|NCT02307682|143202441|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.6|-9.7|
71844196|NCT02307682|143202441|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-11.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-11.4|
71844197|NCT02307682|143202441|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-7.6|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.1|-7.6|
71676670|NCT03514485|142871210|SUPERIORITY||Mean Difference (Net)|-3.07|||||TWO_SIDED|95.0|-5.03|-1.12||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-1.12|-5.03|
71676671|NCT03514485|142871210|SUPERIORITY||Mean Difference (Net)|1.41|||||TWO_SIDED|95.0|-0.48|3.31||||||Mixed-effects generalized linear model with binomial family (n=number of school-days \[varies per child\]) was used to make the comparisons of all combinations of primary care and school-based interventions with respect to school absences. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||3.31|-0.48|
71676672|NCT03514485|142871211|SUPERIORITY||Mean Difference (Net)|0.17|||||TWO_SIDED|95.0|-0.19|0.54||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.19|
71676673|NCT03514485|142871211|SUPERIORITY||Mean Difference (Net)|0.03|||||TWO_SIDED|95.0|-0.28|0.35||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.35|-0.28|
71676674|NCT03514485|142871211|SUPERIORITY||Mean Difference (Net)|-0.34|||||TWO_SIDED|95.0|-0.68|-0.01||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||-0.01|-0.68|
71811344|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.0||||0.289|TWO_SIDED|95.0|-20.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||67|-20|0.289
71844198|NCT02307682|143202441|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-4.4|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||10.0|-4.4|
71811345|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.786|TWO_SIDED|95.0|-37.0|49.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||49|-37|0.786
71811346|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.0||||0.134|TWO_SIDED|95.0|-10.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||76|-10|0.134
71811347|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.0||||0.191|TWO_SIDED|95.0|-15.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||74|-15|0.191
71811348|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.852|TWO_SIDED|95.0|-38.0|46.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||46|-38|0.852
71811349|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0||||0.397|TWO_SIDED|95.0|-24.0|60.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||60|-24|0.397
71811350|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.494|TWO_SIDED|95.0|-28.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||58|-28|0.494
71811351|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.807|TWO_SIDED|95.0|-31.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||40|-31|0.807
71811352|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.386|TWO_SIDED|95.0|-20.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4||51|-20|0.386
71811353|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.0||||0.089|TWO_SIDED|95.0|-4.8|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4||67|-4.8|0.089
71811354|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.958|TWO_SIDED|95.0|-45.0|43.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8||43|-45|0.958
71811355|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.0||||0.766|TWO_SIDED|95.0|-37.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8||50|-37|0.766
71811356|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.06||95.0|-1.7|87.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8||87|-1.7|0.060
71811357|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.678|TWO_SIDED|95.0|-53.0|35.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12||35|-53|0.678
71811358|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0||||0.636|TWO_SIDED|95.0|-33.0|54.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12||54|-33|0.636
71811359|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.094|TWO_SIDED|95.0|-6.5|83.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12||83|-6.5|0.094
71811360|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0||||0.772|TWO_SIDED|95.0|-49.0|37.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16||37|-49|0.772
71811361|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.0||||0.387|TWO_SIDED|95.0|-24.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16||61|-24|0.387
71811362|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.0||||0.243|TWO_SIDED|95.0|-18.0|69.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16||69|-18|0.243
71811363|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0||||0.398|TWO_SIDED|95.0|-62.0|25.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20||25|-62|0.398
71811364|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.0||||0.214|TWO_SIDED|95.0|-16.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20||70|-16|0.214
71811365|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.526|TWO_SIDED|95.0|-30.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20||58|-30|0.526
71811366|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.671|TWO_SIDED|95.0|-53.0|34.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24||34|-53|0.671
71811367|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.355|TWO_SIDED|95.0|-23.0|64.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24||64|-23|0.355
71811368|NCT01218126|143125092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.781|TWO_SIDED|95.0|-38.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24||50|-38|0.781
71811369|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.742|TWO_SIDED|95.0|-66.0|93.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||93|-66|0.742
71811370|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.446|TWO_SIDED|95.0|-109.0|48.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||48|-109|0.446
71811371|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|57.0||||0.157|TWO_SIDED|95.0|-22.0|137.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||137|-22|0.157
71811372|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.0||||0.826|TWO_SIDED|95.0|-93.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||74|-93|0.826
71844199|NCT02307682|143202441|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.9|-7.2|
71676675|NCT03514485|142871211|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.48|0.08||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.08|-0.48|
71811373|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.773||95.0|-95.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||70|-95|0.773
71811374|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|47.0||||0.277|TWO_SIDED|95.0|-38.0|131.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||131|-38|0.277
71811375|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.0||||0.319|TWO_SIDED|95.0|-43.0|132.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||132|-43|0.319
71844200|NCT02307682|143202441|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-6.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.8|-6.3|
71844201|NCT02307682|143202441|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.7|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||9.2|-4.7|
71844202|NCT02307682|143202441|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||10.3|-3.9|
71844203|NCT02307682|143202441|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-12.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-12.6|
71844204|NCT02307682|143202441|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.7|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.9|-12.7|
71844205|NCT02307682|143202441|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-8.1|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.1|
71844206|NCT02307682|143202441|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.2|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||7.9|-6.2|
71844207|NCT02307682|143202441|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.9|-9.6|
71844208|NCT02307682|143202441|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-9.1|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.4|-9.1|
71844209|NCT02307682|143202441|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.1|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.1|-11.1|
71844210|NCT02307682|143202441|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.5|-10.4|
71844211|NCT02307682|143202441|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
71844212|NCT02307682|143202441|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-9.7|
71844213|NCT02307682|143202441|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.5|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||7.9|-5.5|
71844214|NCT02307682|143202441|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.5|-7.2|
71844215|NCT02307682|143202441|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.8|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||8.4|-5.8|
71844216|NCT02307682|143202441|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-7.2|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.9|-7.2|
71844217|NCT02307682|143202441|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-7.9|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.5|-7.9|
71844218|NCT02307682|143202441|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.6|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-6.6|
71844219|NCT02307682|143202441|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-9.4|
71844220|NCT02307682|143202441|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-10.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-10.0|
71844221|NCT02307682|143202441|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-6.2|8.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||8.2|-6.2|
71844222|NCT02307682|143202441|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-5.5|9.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||9.3|-5.5|
71844223|NCT02307682|143202441|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-5.1|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||9.6|-5.1|
71844224|NCT02307682|143202441|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.9|-5.0|
71844225|NCT02307682|143202441|OTHER||Difference in proportions|3.2|||||TWO_SIDED|95.0|-3.9|10.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.3|-3.9|
71844226|NCT02307682|143202441|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-6.1|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||8.1|-6.1|
71844227|NCT02307682|143202441|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.1|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.9|-5.1|
71844228|NCT02307682|143202441|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-5.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.4|-5.9|
71811376|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.716|TWO_SIDED|95.0|-71.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||103|-71|0.716
71811377|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.098|TWO_SIDED|95.0|-14.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-14|0.098
71811378|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.832|TWO_SIDED|95.0|-80.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||100|-80|0.832
71811379|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.0||||0.579|TWO_SIDED|95.0|-64.0|114.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||114|-64|0.579
71811380|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|42.0||||0.369|TWO_SIDED|95.0|-49.0|133.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||133|-49|0.369
71811381|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.0||||0.487|TWO_SIDED|95.0|-121.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||58|-121|0.487
71811382|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0||||0.887|TWO_SIDED|95.0|-82.0|95.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||95|-82|0.887
71844229|NCT02307682|143202441|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.8|-8.5|
71844230|NCT02307682|143202441|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.7|-9.7|
71844231|NCT02307682|143202441|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.9|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-7.9|
71844232|NCT02307682|143202441|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-9.1|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-9.1|
71844233|NCT02307682|143202441|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-2.9|11.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||11.2|-2.9|
71844234|NCT02307682|143202441|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-6.6|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.0|-6.6|
71811383|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.0||||0.486|TWO_SIDED|95.0|-59.0|123.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||123|-59|0.486
71811384|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0||||0.604||95.0|-113.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||66|-113|0.604
71676676|NCT03514485|142871211|SUPERIORITY||Mean Difference (Net)|-0.17|||||TWO_SIDED|95.0|-0.48|0.14||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of ED visits. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.14|-0.48|
71676677|NCT03514485|142871212|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.11|0.29||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.11|
71811385|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.0||||0.872|TWO_SIDED|95.0|-97.0|82.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||82|-97|0.872
71676678|NCT03514485|142871212|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.03|0.34||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.34|-0.03|
71811386|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|43.0||||0.355|TWO_SIDED|95.0|-48.0|134.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||134|-48|0.355
71811387|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.0||||0.839|TWO_SIDED|95.0|-65.0|80.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4||80|-65|0.839
71811388|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.0||||0.741|TWO_SIDED|95.0|-60.0|84.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4||84|-60|0.741
71811389|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.0||||0.056|TWO_SIDED|95.0|-1.8|143.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4||143|-1.8|0.056
71811390|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.0||||0.554|TWO_SIDED|95.0|-107.0|57.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8||57|-107|0.554
71811391|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-30.0||||0.472|TWO_SIDED|95.0|-110.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8||51|-110|0.472
71811392|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.0||||0.116|TWO_SIDED|95.0|-16.0|149.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8||149|-16|0.116
71811393|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0||||0.805|TWO_SIDED|95.0|-98.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12||76|-98|0.805
71811394|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.763|TWO_SIDED|95.0|-73.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12||100|-73|0.763
71811395|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|75.0||||0.096|TWO_SIDED|95.0|-13.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12||163|-13|0.096
71676679|NCT03514485|142871212|SUPERIORITY||Mean Difference (Net)|-0.001|||||TWO_SIDED|95.0|-0.19|0.18||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.19|
71676680|NCT03514485|142871212|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.23|0.09||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.09|-0.23|
71811396|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-31.0||||0.485|TWO_SIDED|95.0|-118.0|56.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16||56|-118|0.485
71811397|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.0||||0.704|TWO_SIDED|95.0|-69.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16||103|-69|0.704
71811398|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|72.0||||0.108|TWO_SIDED|95.0|-16.0|159.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16||159|-16|0.108
71844235|NCT02307682|143202442|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-1.4|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-1.4|
71844236|NCT02307682|143202442|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-0.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||4.0|-0.5|
71811399|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-64.0||||0.147||95.0|-151.0|23.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20||23|-151|0.147
71811400|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.792|TWO_SIDED|95.0|-98.0|75.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20||75|-98|0.792
71811401|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.0||||0.275||95.0|-39.0|138.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20||138|-39|0.275
71811402|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0||||0.53|TWO_SIDED|95.0|-115.0|59.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24||59|-115|0.530
71811403|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.0||||0.827|TWO_SIDED|95.0|-77.0|96.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24||96|-77|0.827
71811404|NCT01218126|143125093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|35.0||||0.434|TWO_SIDED|95.0|-53.0|124.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24||124|-53|0.434
71811405|NCT01218126|143125094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.686|TWO_SIDED|95.0|-3.3|2.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||2.2|-3.3|0.686
71811406|NCT01218126|143125094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5||||0.279|TWO_SIDED|95.0|-1.2|4.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||4.2|-1.2|0.279
71811407|NCT01218126|143125094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.193|TWO_SIDED|95.0|-4.6|0.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.9|-4.6|0.193
71844237|NCT02307682|143202442|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.6|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.5|-2.6|
71844238|NCT02307682|143202442|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-1.7|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-1.7|
71811408|NCT01218126|143125094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.803|TWO_SIDED|95.0|-2.7|3.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||3.5|-2.7|0.803
71811409|NCT01218126|143125094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.229|TWO_SIDED|95.0|-1.2|5.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||5.0|-1.2|0.229
71811410|NCT01218126|143125094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.39|TWO_SIDED|95.0|-4.5|1.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.8|-4.5|0.390
71811411|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.157|TWO_SIDED|95.0|0.91|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.01|0.91|0.157
71811412|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||0.95|0.86|0.000
71811413|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0|TWO_SIDED|95.0|0.86|0.96|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.96|0.86|0.000
71811414|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.072||95.0|0.9|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.00|0.90|0.072
71811415|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0|TWO_SIDED|95.0|0.85|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.95|0.85|0.000
71811416|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88||||0|TWO_SIDED|95.0|0.83|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 8||0.94|0.83|0.000
71811417|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.99||||0.728|TWO_SIDED|95.0|0.93|1.05|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.05|0.93|0.728
71811418|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.002|TWO_SIDED|95.0|0.86|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.97|0.86|0.002
71811419|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.001|TWO_SIDED|95.0|0.84|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.95|0.84|0.001
71811420|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.823|TWO_SIDED|95.0|0.95|1.07|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.07|0.95|0.823
71844239|NCT02307682|143202442|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-3.3|
71844240|NCT02307682|143202442|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.2|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.7|-3.2|
71811421|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96||||0.153|TWO_SIDED|95.0|0.9|1.02|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.02|0.90|0.153
71844241|NCT02307682|143202442|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-3.0|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.4|-3.0|
71895560|NCT03726671|143313728|OTHER|||||||0.0187|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Post-Menopausal Females||||0.0187
71811422|NCT01218126|143125096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.126|TWO_SIDED|95.0|0.9|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.01|0.90|0.126
71844242|NCT02307682|143202442|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.1|-2.4|
71844243|NCT02307682|143202442|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-2.2|
71844244|NCT02307682|143202442|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-0.3|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||5.3|-0.3|
71844245|NCT02307682|143202442|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.2|-2.6|
71844246|NCT02307682|143202442|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-1.8|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||4.6|-1.8|
71844247|NCT02307682|143202442|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-2.9|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.3|-2.9|
71844248|NCT02307682|143202442|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.6|-2.3|
71844249|NCT02307682|143202442|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-2.0|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.1|-2.0|
71844250|NCT02307682|143202442|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-1.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.7|-1.0|
71895561|NCT03726671|143313728|OTHER|||||||0.0107|||||||Mixed Models Analysis|The model evaluates effects from SNP, diet and SNP x diet interaction. Due to crossover design, period and sequence effects were adjusted in the model||SNP effect on Phosphatidylcholine IER in Males||||0.0107
71844251|NCT02307682|143202442|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-1.5|
71811423|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.87||||0.291|TWO_SIDED|95.0|0.68|1.12|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4||1.12|0.68|0.291
71844252|NCT02307682|143202442|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|0.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.5|0.0|
71895562|NCT03726671|143313729|OTHER|||||||0.0842|||||||Mixed Models Analysis|||||||0.0842
71895563|NCT03726671|143313729|OTHER|||||||0.0819|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.0819
71895564|NCT03726671|143313729|OTHER|||||||0.9015|||||||t-test, 2 sided|||||||0.9015
71895565|NCT03726671|143313729|OTHER|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|Non-parametric method was used due to data deviation from normality.||||||0.1191
71895566|NCT03726671|143313730|OTHER|||||||0.2351|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. betaine IER||||0.2351
71895567|NCT03726671|143313730|OTHER|||||||0.4501|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4501
71895568|NCT03726671|143313730|OTHER|||||||0.4136|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.4136
71844253|NCT02307682|143202442|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.1|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-2.1|
71844254|NCT02307682|143202442|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-0.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.3|-0.7|
71844255|NCT02307682|143202442|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-2.2|
71844256|NCT02307682|143202442|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-1.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.2|-1.4|
71844257|NCT02307682|143202442|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.9|-3.2|
71844258|NCT02307682|143202442|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.7|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.3|-2.7|
71844259|NCT02307682|143202442|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.3|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-3.3|
71844260|NCT02307682|143202442|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-2.5|
71844261|NCT02307682|143202442|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.6|-2.4|
71844262|NCT02307682|143202442|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.5|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.3|-1.5|
71844263|NCT02307682|143202442|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.6|-3.5|
71844264|NCT02307682|143202442|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.9|-2.9|
71895569|NCT03726671|143313730|OTHER|||||||0.9463|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.9463
71895570|NCT03726671|143313730|OTHER|||||||0.0675|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.0675
71676681|NCT03514485|142871212|SUPERIORITY||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-0.09|0.26||||||Mixed-effects negative binomial models were used to make the comparisons of all combinations of primary care and school-based interventions with respect to number of hospitalizations. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.26|-0.09|
71844265|NCT02307682|143202442|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-2.4|
71895571|NCT03726671|143313730|OTHER|||||||0.2863|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.2863
71895572|NCT03726671|143313730|OTHER|||||||0.5552|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Betaine IER||||0.5552
71895573|NCT03726671|143313730|OTHER|||||||0.4209|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Phosphatidylcholine IER||||0.4209
71895574|NCT03726671|143313730|OTHER|||||||0.6647|||||||Pearson's Correlation Coefficient|||Liver choline concentration vs. Choline IER||||0.6647
71895575|NCT02839746|143313755|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 2.||||<0.0001
71895576|NCT02839746|143313755|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline satisfaction with that of Visit 2.||||<0.0001
71844266|NCT02307682|143202442|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.7|-1.3|
71844267|NCT02307682|143202442|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-3.1|
71844268|NCT02307682|143202442|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-2.9|
71844269|NCT02307682|143202442|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-2.6|
71844270|NCT02307682|143202442|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.7|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.3|-2.7|
71844271|NCT02307682|143202442|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.1|
71844272|NCT02307682|143202442|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.1|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.0|-2.1|
71844273|NCT02307682|143202442|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-4.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-4.8|
71844274|NCT02307682|143202442|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.9|-4.6|
71844275|NCT02307682|143202442|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-2.6|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.4|-2.6|
71844276|NCT02307682|143202442|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-3.7|
71895577|NCT02839746|143313756|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 3.||||<0.0001
71811424|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.046|TWO_SIDED|95.0|0.61|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4||1.00|0.61|0.046
71895578|NCT02839746|143313756|OTHER|Within group comparison of Baseline satisfaction with that of Visit 3.|||||<|0.0001|||||||non-parametric Wilcoxon signed-rank]|||||||<0.0001
71895579|NCT02839746|143313757|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 convenience with that of Visit 3.||||<0.0001
71811425|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.014|TWO_SIDED|95.0|0.57|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4||0.94|0.57|0.014
71811426|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04||||0.755|TWO_SIDED|95.0|0.82|1.32|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8||1.32|0.82|0.755
71811427|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.029|TWO_SIDED|95.0|0.6|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.97|0.60|0.029
71811428|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.015|TWO_SIDED|95.0|0.58|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8||0.94|0.58|0.015
71811429|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.468|TWO_SIDED|95.0|0.71|1.17|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12||1.17|0.71|0.468
71811430|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73||||0.011||95.0|0.57|0.93|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12||0.93|0.57|0.011
71811431|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0|TWO_SIDED|95.0|0.5|0.82|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12||0.82|0.50|0.000
71811432|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.95||||0.696|TWO_SIDED|95.0|0.74|1.22|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24||1.22|0.74|0.696
71811433|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.81||||0.099|TWO_SIDED|95.0|0.64|1.04|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24||1.04|0.64|0.099
71844277|NCT02307682|143202442|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.4|-3.7|
71844278|NCT02307682|143202442|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.1|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-4.1|
71844279|NCT02307682|143202442|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-2.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.5|-2.2|
71844280|NCT02307682|143202442|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-3.0|
71844281|NCT02307682|143202442|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.9|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.9|-2.9|
71844282|NCT02307682|143202442|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.6|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-3.6|
71844283|NCT02307682|143202443|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.7|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.2|-3.7|
71844284|NCT02307682|143202443|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-2.6|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.4|-2.6|
71844285|NCT02307682|143202443|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-3.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.3|-3.3|
71844286|NCT02307682|143202443|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-3.0|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.9|-3.0|
71895580|NCT02839746|143313757|OTHER||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 satisfaction with that of Visit 3.||||<0.0001
71895581|NCT00849693|143313770|SUPERIORITY_OR_OTHER|||||||0.193||95.0|||||Mixed Models Analysis|||||||0.193
71811434|NCT01218126|143125097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.11|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24||1.11|0.67|0.256
71895582|NCT00984659|143313793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.713|TWO_SIDED|95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.713
71895583|NCT00984659|143313797|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening.|ANCOVA|||||||<0.001
71895584|NCT00984659|143313798|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening.|ANCOVA|||||||<0.001
71895585|NCT00984659|143313799|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening|ANCOVA|||||||0.008
71895586|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.18|0.31||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 8|ANCOVA|||||0.31|0.18|<0.001
71895587|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.001||95.0|0.06|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 15|ANCOVA|||||0.19|0.06|<0.001
71895588|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.16||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 22|ANCOVA|||||0.16|0.06|<0.001
71895589|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.17||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 29|ANCOVA|||||0.17|0.06|<0.001
71895590|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|||<|0.001||95.0|0.08|0.18||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 36|ANCOVA|||||0.18|0.08|<0.001
71895591|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.18||95.0|-0.03|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 43|ANCOVA|||||0.15|-0.03|0.180
71895592|NCT00984659|143313801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.307||95.0|-0.07|0.23||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Visit 3/PD|ANCOVA|||||0.23|-0.07|0.307
71895593|NCT00984659|143313805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.14|0.34||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CGI-C responders and non-responders|ANCOVA|||||0.34|0.14|<0.001
71895594|NCT00984659|143313806|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.4||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CRQ-SAS Dyspnea Domain responders and non-responders|ANCOVA|||||0.40|0.21|<0.001
71895595|NCT00984659|143313807|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.535||95.0|-0.08|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders|ANCOVA|||||0.15|-0.08|0.535
71895596|NCT00984659|143313807|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.08||95.0|-0.02|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders|ANCOVA|||||0.19|-0.02|0.08
71895597|NCT02951273|143313812|SUPERIORITY|||||||0.0276|||||||repeated measure mixed model|||||||0.0276
71895598|NCT02951273|143313813|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
71895599|NCT02951273|143313814|SUPERIORITY|||||||0.6025|||||||Regression, Linear|||||||0.6025
71895600|NCT02951273|143313815|SUPERIORITY|||||||0.3213|||||||repeated measure mixed model|||||||0.3213
71895601|NCT02951273|143313816|SUPERIORITY|||||||0.0005||||||The reported p-value was calculated|repeated measure mixed model|||||||0.0005
71895602|NCT02951273|143313817|SUPERIORITY|||||||0.5404|||||||repeated measure mixed model|||||||0.5404
71895603|NCT02951273|143313818|SUPERIORITY|||||||0.8947|||||||repeated measure mixed model|||||||0.8947
71895604|NCT02951273|143313819|SUPERIORITY|||||||0.0068|||||||Linear mixed models|||||||0.0068
71895605|NCT02951273|143313820|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
71895606|NCT02951273|143313821|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71895607|NCT02951273|143313822|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
71895608|NCT02951273|143313823|SUPERIORITY||||||<|0.0001|||||||repeated measure mixed model|||||||<0.0001
71895609|NCT00121225|143313828|SUPERIORITY|||||||0.029|||||||Fisher Exact|||||||0.029
71895610|NCT02424149|143313914|SUPERIORITY_OR_OTHER|||||||0.77|||||||t-test, 2 sided|||||||0.77
71895611|NCT02424149|143313915|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71895612|NCT02424149|143313916|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71895613|NCT02424149|143313917|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
71895614|NCT02424149|143313918|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
71895615|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
71895616|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
71844287|NCT02307682|143202443|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-4.6|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-4.6|
71895617|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.61|0.44|
71895618|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
71895619|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.24|0.18|
71895620|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.41|0.31|
71895621|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.32|0.19|
71895622|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
71895623|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.30|0.17|
71895624|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.39|0.25|
71895625|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.38|0.27|
71844288|NCT02307682|143202443|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.6|-3.5|
71844289|NCT02307682|143202443|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.9|-4.2|
71844290|NCT02307682|143202443|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-5.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.0|-5.0|
71895626|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
71895627|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.20|0.10|
71895628|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
71895629|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.09|0.16|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.16|0.09|
71895630|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.41|
71895631|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.43|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.43|
71895632|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.38|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.38|
71895633|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.6|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.00|0.60|
71895634|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.51|
71895635|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.86|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|0.86|
71895636|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.41|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.80|0.41|
71895637|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.73|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.73|0.39|
71895638|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.78|1.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|0.78|
71676682|NCT03514485|142871213|SUPERIORITY||Mean Difference (Net)|0.32|||||TWO_SIDED|95.0|0.0|0.65||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.65|0.00|
71895639|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.71|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.71|
71895640|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.75|0.54|
71895641|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.06|0.78|
71895642|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.51|0.29|
71895643|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.39|
71895644|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.53|
71895645|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.49|
71895646|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.52|0.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.63|0.52|
71895647|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.53|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.66|0.53|
71811435|NCT01218126|143125098|SUPERIORITY_OR_OTHER||Rate ratio|1.0||||0.989|TWO_SIDED|95.0|0.64|1.54|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 2.5 mg arm) / (Rate of exacerbation in placebo arm)|Losmapimod 2.5 mg versus Placebo||1.54|0.64|0.989
71811436|NCT01218126|143125098|SUPERIORITY_OR_OTHER||Rate ratio|0.98||||0.915||95.0|0.64|1.5|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 7.5 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 7.5 mg||1.50|0.64|0.915
71811437|NCT01218126|143125098|SUPERIORITY_OR_OTHER||Rate ratio|0.74||||0.21|TWO_SIDED|95.0|0.47|1.18|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 15 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 15 mg||1.18|0.47|0.210
71811438|NCT01860703|143125100|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||||TWO_SIDED|90.0|1.02|5.01||||||||5.01|1.02|
71811439|NCT01860703|143125106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.23|||||TWO_SIDED|90.0|3.26|7.19||||||||7.19|3.26|
71811440|NCT01860703|143125109|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|13.42|||||TWO_SIDED|90.0|11.1|15.75||||||||15.75|11.10|
71811441|NCT02453685|143125112|SUPERIORITY_OR_OTHER||Treatment difference at week 32|0.18||||0.0435|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis||"'Treatment difference' refers to BIAsp 30 minus Basal-bolus"|Analysis was performed using mixed model repeated measurements including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix.||0.36|0.01|0.0435
71811442|NCT01165775|143125216|SUPERIORITY_OR_OTHER|||||||0.2155|||||||Chi-squared|||||||0.2155
71811443|NCT01023568|143125233|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|14.0|||>|0.99|TWO_SIDED|95.0|7.0|26.0|||Wilcoxon (Mann-Whitney)||Glidescope - direct laryngoscopy|||26|7|>0.99
71811444|NCT01023568|143125233|NON_INFERIORITY_OR_EQUIVALENCE|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|17.0|||>|0.99|TWO_SIDED|95.0|6.0|28.0|||Wilcoxon (Mann-Whitney)||Truview PCD - direct laryngoscopy|||28|6|>0.99
71811445|NCT01023568|143125234|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANOVA|||||||0.28
71811446|NCT01023568|143125235|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||>|0.99|TWO_SIDED|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||2|1|> 0.99
71811447|NCT01023568|143125235|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.18|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.||0|0|0.18
71844291|NCT02307682|143202443|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.4|-4.1|
71844292|NCT02307682|143202443|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-2.3|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.7|-2.3|
71844293|NCT02307682|143202443|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.1|-3.9|
71811448|NCT01023568|143125236|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
71811449|NCT01023568|143125237|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
71811450|NCT00508261|143125252|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.64|||||TWO_SIDED|95.0|-0.33|4.71||||||Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.||4.71|-0.33|
71811451|NCT00508261|143125252|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.73|||||TWO_SIDED|95.0|0.73|6.24||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.||6.24|0.73|
71676683|NCT03514485|142871213|SUPERIORITY||Mean Difference (Net)|0.16|||||TWO_SIDED|95.0|-0.12|0.45||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.45|-0.12|
71676684|NCT03514485|142871213|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.4|0.18||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.18|-0.40|
71676685|NCT03514485|142871213|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.2|0.29||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.29|-0.20|
71811452|NCT00508261|143125252|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.61|||||TWO_SIDED|95.0|-0.36|4.64||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.||4.64|-0.36|
71676686|NCT03514485|142871213|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.08|0.5||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL emotional functioning domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.50|-0.08|
71676687|NCT03514485|142871214|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.19|0.69||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.69|-0.19|
71811453|NCT00508261|143125252|NON_INFERIORITY|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.7|||||TWO_SIDED|95.0|0.71|6.18||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.||6.18|0.71|
71811454|NCT00508261|143125253|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.97|||||TWO_SIDED|95.0|0.83|1.12||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.||1.12|0.83|
71811455|NCT00508261|143125253|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.98|||||TWO_SIDED|95.0|0.85|1.13||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.||1.13|0.85|
71811456|NCT00508261|143125253|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.92|||||TWO_SIDED|95.0|0.78|1.1||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.||1.1|0.78|
71811457|NCT00508261|143125254|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.22|||||TWO_SIDED|95.0|-1.47|4.6||||||||4.6|-1.47|
71811458|NCT00508261|143125255|NON_INFERIORITY|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.19|||||TWO_SIDED|95.0|-1.45|4.5||||||||4.5|-1.45|
71811459|NCT04067401|143125332|SUPERIORITY||Effect size|-0.13||||0.062|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.01|-.29|.062
71844294|NCT02307682|143202443|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.2|-1.8|
71676688|NCT03514485|142871214|SUPERIORITY||Mean Difference (Net)|0.25|||||TWO_SIDED|95.0|-0.14|0.63||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.63|-0.14|
71676689|NCT03514485|142871214|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.49|0.3||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.30|-0.49|
71676690|NCT03514485|142871214|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.43|0.24||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.24|-0.43|
71676691|NCT03514485|142871214|SUPERIORITY||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.24|0.54||||||Mixed-effects linear models with random intercepts for school and child were used to make the comparisons of all combinations of primary care and school-based interventions with respect to QOL activity limitations domain. Contrasts across time and levels of the intervention were obtained by subtraction. Models were not adjusted for timing of intervention delivery during the Coronavirus (COVID-19) pandemic.||0.54|-0.24|
71676692|NCT00791661|142871219|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.92||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
71676693|NCT00791661|142871221|SUPERIORITY_OR_OTHER||Geometric mean ratio (fed/fasted)|0.81||||||95.0|||||Mixed-effect model|Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.||||||
71811460|NCT04067401|143125333|SUPERIORITY||Effect size|-0.23||||0.001|TWO_SIDED|95.0|-0.39|-0.09|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.09|-.39|.001
71811461|NCT04067401|143125334|SUPERIORITY||Effect size|-0.16||||0.027|TWO_SIDED|95.0|-0.34|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.34|.027
71811462|NCT04067401|143125335|SUPERIORITY||Effect size|-0.24||||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.08|-.41|.002
71811463|NCT04067401|143125336|SUPERIORITY||Effect size|0.01||||0.821|TWO_SIDED|95.0|-0.12|0.11|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.11|-.12|.821
71811464|NCT04067401|143125337|SUPERIORITY||Effect size|-0.14||||0.024|TWO_SIDED|95.0|-0.31|-0.02|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||-.02|-.31|.024
71811465|NCT04067401|143125338|SUPERIORITY||Effect size|0.18||||0.012|TWO_SIDED|95.0|0.04|0.29|||Mixed Models Analysis|Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component||||.29|.04|.012
71811466|NCT04067401|143125339|SUPERIORITY||Effect size|0.21||||0.01|TWO_SIDED|95.0|0.05|0.35||Model adjusts for class (random effect) and sex, age, race/ethnicity, and Air Force component|Mixed Models Analysis|||||.35|.05|.010
71811467|NCT00106184|143125398|SUPERIORITY_OR_OTHER||||||=|0.74|TWO_SIDED||||||Log Rank|No confidence intervals as no parameters were estimated.||Proportional hazards model||||=0.74
71811468|NCT00106184|143125399|SUPERIORITY_OR_OTHER||||||>|0.9|TWO_SIDED|95.0|||||Chi-squared|Difference in baseline muscle enzymes therefore tested the difference in the proportions adjusting for the baseline values.||||||>0.90
71811469|NCT00106184|143125400|SUPERIORITY_OR_OTHER||||||>|0.9|||||||Log Rank|||||||>0.90
71676694|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-8.1||||0.368|TWO_SIDED|90.0|-23.0|6.8||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||6.8|-23.0|0.368
71676695|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-16.6||||0.079|TWO_SIDED|90.0|-32.2|-1.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-1.1|-32.2|0.079
71811470|NCT02313909|143125401|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.51884|TWO_SIDED|95.0|0.87|1.33|||Log Rank|||Statistical analysis: Stroke + Systemic embolism: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.33|0.87|0.51884
71811471|NCT02313909|143125402|SUPERIORITY||Hazard Ratio (HR)|2.72||||2e-05|TWO_SIDED|95.0|1.68|4.39|||Log Rank|||Statistical analysis: ISTH major bleeding events: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.39|1.68|0.00002
71811472|NCT02313909|143125403|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.56922|TWO_SIDED|95.0|0.87|1.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.87|0.56922
71676696|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-25.7||||0.007|TWO_SIDED|90.0|-40.9|-10.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-10.5|-40.9|0.007
71676697|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Diffrence in least squares mean|-36.3|||<|0.001|TWO_SIDED|90.0|-52.0|-20.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-20.5|-52.0|<.001
71676698|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-19.7||||0.147|TWO_SIDED|90.0|-42.2|2.7|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.|||2.7|-42.2|0.147
71844295|NCT02307682|143202443|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.7|-3.5|
71676699|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|12.3||||0.114|TWO_SIDED|90.0|-0.5|25.2|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.|||25.2|-0.5|0.114
71844296|NCT02307682|143202443|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.6|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.4|-3.6|
71844297|NCT02307682|143202443|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.6|-3.2|
71844298|NCT02307682|143202443|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-3.2|
71844299|NCT02307682|143202443|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.3|-2.6|
71844300|NCT02307682|143202443|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.1|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||5.9|-2.1|
71844301|NCT02307682|143202443|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.9|-4.3|
71811473|NCT02313909|143125404|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.22078|TWO_SIDED|95.0|0.87|1.81|||Log Rank|||Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.81|0.87|0.22078
71811474|NCT02313909|143125405|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4797|TWO_SIDED|95.0|0.87|1.34|||Log Rank|||Statistical analysis 1: Stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.34|0.87|0.47970
71844302|NCT02307682|143202443|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-3.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.8|-3.6|
71844303|NCT02307682|143202443|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.8|-3.7|
71811475|NCT02313909|143125405|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.78738|TWO_SIDED|95.0|0.83|1.29|||Log Rank|||Statistical analysis 2: Ischemic stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.29|0.83|0.78738
71811476|NCT02313909|143125405|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.14822|TWO_SIDED|95.0|0.88|2.28|||Log Rank|||Statistical analysis 3: Disabling stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.28|0.88|0.14822
71811477|NCT02313909|143125405|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.14051|TWO_SIDED|95.0|0.87|2.52|||Log Rank|||Statistical analysis 4:CV death: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.52|0.87|0.14051
71811478|NCT02313909|143125405|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.34284|TWO_SIDED|95.0|0.39|1.38|||Log Rank|||Statistical analysis 5: Myocardial infarction: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||1.38|0.39|0.34284
71811479|NCT02313909|143125406|SUPERIORITY||Hazard Ratio (HR)|2.34||||0.00443|TWO_SIDED|95.0|1.28|4.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.29|1.28|0.00443
71811480|NCT02313909|143125407|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.00451|TWO_SIDED|95.0|1.13|2.0|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||2.00|1.13|0.00451
71811481|NCT02313909|143125408|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.04409|TWO_SIDED|95.0|1.0|4.02|||Log Rank|||Statistical analysis 1: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.||4.02|1.00|0.04409
71811482|NCT03086330|143125442|OTHER||Treatment difference|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.61|-1.24|||ANCOVA|||The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-1.24|-1.61|<0.0001
71811483|NCT03086330|143125443|OTHER||Treatment difference|-3.81|||<|0.0001|TWO_SIDED|95.0|-4.7|-2.93|||ANCOVA|||The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.||-2.93|-4.70|<0.0001
71811484|NCT01446666|143125518|SUPERIORITY||||||<|0.01|||||||McNemar|||The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.||||<0.01
71811485|NCT01446666|143125519|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
71811486|NCT01446666|143125520|SUPERIORITY||||||<|0.01|||||||McNemar|||||||<0.01
71811487|NCT01446666|143125521|SUPERIORITY|||||||0.004|||||||McNemar|||||||0.004
71811488|NCT01814748|143125526|SUPERIORITY_OR_OTHER||Difference in least squares means|0.12||||0.535|TWO_SIDED|95.0|-0.26|0.49|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||0.49|-0.26|0.535
71811489|NCT01814748|143125527|SUPERIORITY_OR_OTHER||Difference in percent|-0.4|||||TWO_SIDED|95.0|-13.8|13.0||||||||13.0|-13.8|
71811490|NCT01814748|143125528|SUPERIORITY_OR_OTHER||Difference in percent|-2.0||||||||||||||||||
71811491|NCT01814748|143125529|SUPERIORITY_OR_OTHER||Difference in least squares means|4.2||||0.685|TWO_SIDED|95.0|-16.1|24.4|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||24.4|-16.1|0.685
71676700|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-28.9||||0.026|TWO_SIDED|90.0|-49.9|-7.9|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.|||-7.9|-49.9|0.026
71811492|NCT01814748|143125530|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.586|TWO_SIDED|95.0|-17.1|9.7|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||||9.7|-17.1|0.586
71676701|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-57.6|||<|0.001|TWO_SIDED|90.0|-73.3|-41.9||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-41.9|-73.3|<.001
71811493|NCT01814748|143125531|SUPERIORITY_OR_OTHER||Between-group rate difference|-0.4|||||TWO_SIDED|95.0|-14.0|13.1|||Mietinnen and Nurminen|||||13.1|-14.0|
71811494|NCT01814748|143125532|SUPERIORITY_OR_OTHER||Between-group rate difference|4.0|||||TWO_SIDED|95.0|-7.4|15.5|||Mietinnen and Nurminen|||||15.5|-7.4|
71811495|NCT01972529|143125538|SUPERIORITY||Difference of proportion vs placebo|42.6|||<|0.0001|TWO_SIDED|95.0|27.2|58.1|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion versus (vs) placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||58.1|27.2|<0.0001
71811496|NCT01972529|143125538|SUPERIORITY||Difference of proportion vs placebo|49.9|||<|0.0001|TWO_SIDED|95.0|31.6|68.2|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||68.2|31.6|<0.0001
71811497|NCT01972529|143125539|SUPERIORITY||Difference of proportion vs placebo|64.7|||<|0.0001|TWO_SIDED|95.0|53.6|75.8|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||75.8|53.6|<0.0001
71811498|NCT01972529|143125539|SUPERIORITY||Difference of percentage vs placebo|67.5|||<|0.0001|TWO_SIDED|95.0|51.6|83.4|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||83.4|51.6|<0.0001
71811499|NCT01972529|143125540|SUPERIORITY||Difference in change of platelet count|27.5|||<|0.0001|TWO_SIDED|95.0|22.5|32.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||32.5|22.5|<0.0001
71811500|NCT01972529|143125540|SUPERIORITY||Difference in change of platelet count|33.0|||<|0.0001|TWO_SIDED|95.0|25.5|41.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||41.5|25.5|<0.0001
71811501|NCT02274857|143125543|SUPERIORITY|||||||0.2179|||||||Chi-squared|||||||0.2179
71811502|NCT02274857|143125544|SUPERIORITY|||||||0.2782|||||||Chi-squared|||||||0.2782
71811503|NCT02274857|143125545|SUPERIORITY|||||||0.7266|||||||Chi-squared|||||||0.7266
71811504|NCT02274857|143125546|SUPERIORITY|||||||0.3522|||||||Chi-squared|||||||0.3522
71811505|NCT00330174|143125550|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Mixed Models Analysis|||Drinking outcomes were analyzed using multiple linear regression, controlling for site and baseline drinking level. Drinking and psychiatric symptoms assessed over time were examined using repeated measures (intercept only) mixed linear models (PROC MIXED in SAS). Analyses were performed using SAS statistical software (version 9.2; SAS Institute, Inc., Cary, NC). All tests were two-tailed and p-values less than 0.05 were considered statistically significant.||||0.64
71811506|NCT01032733|143125554|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.06|STANDARD_DEVIATION|0.5|<|0.05|ONE_SIDED|95.0|||||ANCOVA|||This trial represented a pilot study, which was designed to demonstrate the feasibility, acceptability, and efficacy of the intervention; therefore, a power analysis was not conducted. The statistical analyses consisted of descriptive and intent-to-treat (ITT) modeling procedures.||||<0.05
71811507|NCT01032733|143125555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|5.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71811508|NCT01032733|143125556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71811509|NCT01032733|143125557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71811510|NCT01032733|143125558|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71844304|NCT02307682|143202443|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-3.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.7|-3.7|
71676702|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-15.3||||0.099|TWO_SIDED|90.0|-30.5|-0.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-0.1|-30.5|0.099
71676703|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-43.9|||<|0.001|TWO_SIDED|90.0|-60.8|-27.0||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-27.0|-60.8|<.001
71811511|NCT00409682|143125559|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.29||||0.075|TWO_SIDED|95.0|-3.14|23.71||There is no adjustment for multiple comparison on the primary outcome measure.|Cochran-Mantel-Haenszel||Difference is between adalimumab High-dose and adalimumab Low-dose group.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.||23.71|-3.14|0.075
71811512|NCT00409682|143125560|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.18||||0.1|TWO_SIDED|95.0|-2.62|22.97||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||22.97|-2.62|0.100
71811513|NCT00409682|143125561|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.72||||0.073|TWO_SIDED|95.0|-3.45|24.89||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||24.89|-3.45|0.073
71811514|NCT00409682|143125562|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.51||||0.038|TWO_SIDED|95.0|-0.01|27.04||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.||27.04|-0.01|0.038
71811515|NCT00409682|143125563|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|2.903||0.161|TWO_SIDED|95.0|-9.86|1.66||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|"Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.~The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience)."||1.66|-9.86|0.161
71811516|NCT00409682|143125564|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.941||0.735|TWO_SIDED|95.0|-6.88|4.88|||ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.||4.88|-6.88|0.735
71811517|NCT00118716|143125573|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|STANDARD_ERROR_OF_MEAN|1.29||0.021|TWO_SIDED|95.0|0.5|5.6||LS Mean Difference, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for maximal percent change in FEV1 following exercise challenge at Week 4.||5.6|0.5|0.021
71844305|NCT02307682|143202443|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-2.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-2.2|
71895648|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.64|0.42|
71895649|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.60|0.44|
71895650|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.88|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.88|0.63|
71895651|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.26|0.15|
71895652|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.35|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.35|0.23|
71895653|NCT01025336|143313920|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
71895654|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.56|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.56|0.42|
71895655|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.56|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.56|
71895656|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
71895657|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.44|0.57|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.57|0.44|
71895658|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.60|
71811518|NCT00118716|143125574|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.085|<|0.001|TWO_SIDED|95.0|0.24|0.58||LS Mean Diff, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for post-dose FEV1 AUC Day 1.||0.58|0.24|<0.001
71895659|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.97|0.63|
71895660|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.81|1.08|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.08|0.81|
71895661|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.74|0.99|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.99|0.74|
71895662|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
71844306|NCT02307682|143202443|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.9|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.3|-2.9|
71844307|NCT02307682|143202443|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.5|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.8|-3.5|
71844308|NCT02307682|143202443|OTHER||Difference in proportions|3.0|||||TWO_SIDED|95.0|-1.6|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.3|-1.6|
71844309|NCT02307682|143202443|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.3|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-2.3|
71844310|NCT02307682|143202443|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-2.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.7|-2.2|
71844311|NCT02307682|143202443|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.8|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-4.8|
71844312|NCT02307682|143202443|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.8|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.9|-3.8|
71844313|NCT02307682|143202443|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-3.1|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-3.1|
71895663|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
71895664|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.45|0.31|
71895665|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.59|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.59|0.40|
71811519|NCT00118716|143125575|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1|STANDARD_ERROR_OF_MEAN|4.83||0.097|TWO_SIDED|95.0|-1.5|17.6||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for AM PEF||17.6|-1.5|0.097
71811520|NCT00118716|143125576|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|4.3||0.396|TWO_SIDED|95.0|-4.8|12.1||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID PM PEF.||12.1|-4.8|0.396
71844314|NCT02307682|143202443|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||6.4|-2.8|
71844315|NCT02307682|143202443|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-3.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.2|-3.4|
71844316|NCT02307682|143202443|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.8|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.6|-2.8|
71844317|NCT02307682|143202443|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-6.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.5|-6.6|
71844318|NCT02307682|143202443|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.8|-6.1|
71844319|NCT02307682|143202443|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.6|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.1|-5.6|
71844320|NCT02307682|143202443|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-2.9|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.9|-2.9|
71844321|NCT02307682|143202443|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.8|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.1|-5.8|
71844322|NCT02307682|143202443|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.5|-3.2|
71844323|NCT02307682|143202443|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.2|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.0|-4.2|
71895666|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.58|0.96|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.96|0.58|
71895667|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.67|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.67|
71895668|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.67|0.37|
71895669|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.57|1.12|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.12|0.57|
71676704|NCT00791661|142871225|SUPERIORITY_OR_OTHER||Difference in least squares mean|-59.4|||<|0.001|TWO_SIDED|90.0|-75.1|-43.7||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.||-43.7|-75.1|<.001
71895670|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.09|0.85|
71844324|NCT02307682|143202443|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.7|-3.2|
71844325|NCT02307682|143202443|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.2|-5.8|
71844326|NCT02307682|143202443|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.2|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.6|-5.2|
71844327|NCT02307682|143202443|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-5.5|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.1|-5.5|
71844328|NCT02307682|143202443|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-5.3|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.4|-5.3|
71844329|NCT02307682|143202443|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.7|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.4|-5.7|
71844330|NCT02307682|143202443|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.3|-3.4|
71676705|NCT02438826|142871237|SUPERIORITY||LSMean Difference|-0.8||||0.334|TWO_SIDED|95.0|-2.77|1.17||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||1.17|-2.77|0.334
71676706|NCT02438826|142871238|SUPERIORITY||Odds Ratio (OR)|1.297||||0.17|TWO_SIDED|95.0|0.83|2.028||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis|||||2.028|0.830|0.170
71676707|NCT02438826|142871239|SUPERIORITY|||||||0.946||||||Chui, Hung, Wang (CHW) procedure applied)|Mixed Models Analysis|||||||0.946
71676708|NCT02438826|142871240|SUPERIORITY||Odds Ratio (OR)|1.51||||0.057|TWO_SIDED|95.0|0.987|2.309|||Mixed Models Analysis|||||2.309|0.987|0.057
71844331|NCT02307682|143202444|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.5|-2.4|
71844332|NCT02307682|143202444|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-1.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||6.8|-1.8|
71844333|NCT02307682|143202444|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-4.1|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.8|-4.1|
71844334|NCT02307682|143202444|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-1.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||6.8|-1.7|
71844335|NCT02307682|143202444|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.3|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||6.5|-2.3|
71844336|NCT02307682|143202444|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.9|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||7.9|-0.9|
71844337|NCT02307682|143202444|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.4|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.0|-5.4|
71676709|NCT02438826|142871241|SUPERIORITY||Odds Ratio (OR)|1.141||||0.713|TWO_SIDED|95.0|0.563|2.314|||Mixed Models Analysis|||||2.314|0.563|0.713
71811521|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.168|TWO_SIDED|95.0|-0.08|0.43||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 2||0.43|-0.08|0.168
71811522|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.147||0.465|TWO_SIDED|95.0|-0.18|0.4||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 4.||0.40|-0.18|0.465
71811523|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.133||0.222|TWO_SIDED|95.0|-0.1|0.42||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Endpoint.||0.42|-0.10|0.222
71895671|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.04|
71811524|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.096||0.294|TWO_SIDED|95.0|-0.29|0.09||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 2.||0.09|-0.29|0.294
71811525|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.111||0.828|TWO_SIDED|95.0|-0.24|0.19||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 4.||0.19|-0.24|0.828
71811526|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.903|TWO_SIDED|95.0|-0.19|0.22||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Endpoint.||0.22|-0.19|0.903
71811527|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.112||0.464|TWO_SIDED|95.0|-0.3|0.14|||ANCOVA|LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 2.||0.14|-0.30|0.464
71811528|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.551|TWO_SIDED|95.0|-0.32|0.17||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 4.||0.17|-0.32|0.551
71811529|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.123||0.633|TWO_SIDED|95.0|-0.3|0.18||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Endpoint.||0.18|-0.30|0.633
71811530|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.094||0.7|TWO_SIDED|95.0|-0.22|0.15||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 2.||0.15|-0.22|0.700
71811531|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.109||0.86|TWO_SIDED|95.0|-0.23|0.2||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 4.||0.20|-0.23|0.860
71811532|NCT00118716|143125579|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.103||0.919|TWO_SIDED|95.0|-0.19|0.21||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Endpoint.||0.21|-0.19|0.919
71811533|NCT02657317|143125601|SUPERIORITY||Mean Difference (Final Values)|-9.1||||0.001|TWO_SIDED|95.0|-14.4|-3.7|||GLMM|||To detect a medium effect (d = 0.50) at 2-sided α = 0.05, 50 participants were needed in each study arm (total N = 100). We anticipated 30% attrition in each arm. Data for the primary aim were analyzed using generalized linear mixed models adjusting for baseline levels of prognostic variable and using random intercepts at the level of participants. The primary analysis was based on intent-to-treat.||-3.7|-14.4|.001
71895672|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.48|0.62|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.62|0.48|
71676710|NCT02438826|142871242|SUPERIORITY||Odds Ratio (OR)|1.008||||0.979|TWO_SIDED|95.0|0.548|1.856|||Mixed Models Analysis|||||1.856|0.548|0.979
71676711|NCT02438826|142871243|SUPERIORITY||Odds Ratio (OR)|0.788||||0.437|TWO_SIDED|95.0|0.431|1.44|||Mixed Models Analysis|||||1.440|0.431|0.437
71676712|NCT00926848|142871267|SUPERIORITY||Mean Difference (Final Values)|4.0|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71844338|NCT02307682|143202444|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.2|-6.2|
71844339|NCT02307682|143202444|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.4|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-5.4|
71844340|NCT02307682|143202444|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-2.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.4|-2.9|
71844341|NCT02307682|143202444|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.9|-5.2|
71844342|NCT02307682|143202444|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.4|8.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||8.8|-1.4|
71844343|NCT02307682|143202444|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-6.8|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-6.8|
71844344|NCT02307682|143202444|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.7|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.8|-4.7|
71844345|NCT02307682|143202444|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.4|-5.0|
71844346|NCT02307682|143202444|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-6.1|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-6.1|
71844347|NCT02307682|143202444|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.8|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||7.7|-1.8|
71844348|NCT02307682|143202444|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.8|-2.7|
71844349|NCT02307682|143202444|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-5.9|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.0|-5.9|
71844350|NCT02307682|143202444|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.9|-4.7|
71844351|NCT02307682|143202444|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.5|-5.7|
71844352|NCT02307682|143202444|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.5|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.3|-6.5|
71844353|NCT02307682|143202444|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.7|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.9|-2.7|
71895673|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.83|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.83|0.59|
71676713|NCT00926848|142871268|SUPERIORITY||Mean Difference (Final Values)|6.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71811534|NCT02856113|143125602|SUPERIORITY||Least Square (LS) Mean Difference|0.102|STANDARD_DEVIATION|0.3677|=|0.782|TWO_SIDED|95.0|-0.627|0.831||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|||0.831|-0.627|=0.782
71811535|NCT02856113|143125603|SUPERIORITY||LS Mean Difference|-0.046|STANDARD_DEVIATION|0.2635|=|0.863|TWO_SIDED|95.0|-0.567|0.476||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 12||0.476|-0.567|=0.863
71811536|NCT02856113|143125603|SUPERIORITY||LS Mean Difference|0.004|STANDARD_DEVIATION|0.3123|=|0.99|TWO_SIDED|95.0|-0.614|0.622||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 18||0.622|-0.614|=0.990
71811537|NCT02856113|143125603|SUPERIORITY||LS Mean Difference|-0.412|STANDARD_DEVIATION|0.3664|=|0.264|TWO_SIDED|95.0|-1.139|0.316||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 39||0.316|-1.139|=0.264
71811538|NCT02856113|143125603|SUPERIORITY||LS Mean Difference|-0.483|STANDARD_DEVIATION|0.4165|=|0.25|TWO_SIDED|95.0|-1.314|0.348||P-values was assessed at 0.05 significance level using MMRM.|MMRM||MMRM:Treatment,scheduled visit,antidiabetic therapy,visit-by-treatment interaction-categorical effects;Baseline HbA1c,visit-by-baseline HbA1c interaction-continuous covariates;unstructured covariance matrix for correlation of repeated measurements.|Change From Baseline at Week 52||0.348|-1.314|=0.250
71811539|NCT03477279|143125614|SUPERIORITY||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-5.6|7.3|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||7.3|-5.6|
71811540|NCT03477279|143125615|SUPERIORITY||Risk Difference (RD)|6.6|||||TWO_SIDED|95.0|-0.8|14.0|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||14.0|-0.8|
71844354|NCT02307682|143202444|OTHER||Difference in proportions|0.8|||||TWO_SIDED|95.0|-4.3|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.4|-4.3|
71895674|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.57|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.72|0.57|
71895675|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.65|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.65|
71895676|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.66|0.93|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.93|0.66|
71895677|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||1.05|0.75|
71895678|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.27|0.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.37|0.27|
71895679|NCT01025336|143313921|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.||0.48|0.34|
71895680|NCT01025336|143313922|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
71895681|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.79|
71676714|NCT00926848|142871269|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71676715|NCT00926848|142871270|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71676716|NCT00926848|142871271|SUPERIORITY||Mean Difference (Final Values)|0.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71676717|NCT00926848|142871272|SUPERIORITY||Mean Difference (Final Values)|0.8|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71811541|NCT03477279|143125616|SUPERIORITY||Risk Difference (RD)|10.0|||||TWO_SIDED|95.0|-1.7|21.7|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||21.7|-1.7|
71811542|NCT03477279|143125617|SUPERIORITY||Risk Difference (RD)|16.6|||||TWO_SIDED|95.0|0.9|32.3|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||32.3|0.9|
71811543|NCT03477279|143125618|SUPERIORITY||Risk Difference (RD)|15.1|||||TWO_SIDED|95.0|-1.6|31.8||||||||31.8|-1.6|
71811544|NCT03477279|143125619|SUPERIORITY||Risk Difference (RD)|-2.4|||||TWO_SIDED|95.0|-13.2|8.5|||||Male Partners of Women in Couple - Male Partners of Women in Individual|||8.5|-13.2|
71811545|NCT03477279|143125620|SUPERIORITY||Risk Difference (RD)|-4.5|||||TWO_SIDED|95.0|-10.0|10.7|||||Couple (HIV+ Women) - Individual (HIV+ Women)|||10.7|-10.0|
71811546|NCT03477279|143125621|OTHER||Odds Ratio (OR)|4.9|||||TWO_SIDED|95.0|1.7|13.9||||||||13.9|1.7|
71811547|NCT01422408|143125694|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.|||||<|0.001||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||<0.001
71811548|NCT01422408|143125694|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.001|TWO_SIDED|95.0|0.0|0.36||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||0.36|0|0.001
71811549|NCT01422408|143125695|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.002||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.||||0.002
71811550|NCT01422408|143125695|OTHER|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.062|TWO_SIDED|95.0|0.0|1.09||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"||1.09|0|0.062
71811551|NCT01422408|143125696|OTHER|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.001
71811552|NCT01422408|143125697|OTHER|2.5% significance level to account for two co-primary endpoints.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.||||0.002
71811553|NCT01422408|143125699|OTHER|||||||0.1029||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1029
71811554|NCT01422408|143125700|OTHER|||||||0.2678||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2678
71811555|NCT01422408|143125701|OTHER|||||||0.2472||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2472
71811556|NCT01422408|143125702|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
71811557|NCT01422408|143125703|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
71895682|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.69|0.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.90|0.69|
71811558|NCT01422408|143125704|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
71811559|NCT01422408|143125705|OTHER|||||||0.6587||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6587
71811560|NCT01422408|143125706|OTHER|||||||0.8772||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8772
71811561|NCT01422408|143125707|OTHER|||||||0.7395||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7395
71811562|NCT01422408|143125708|OTHER|||||||0.9618||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9618
71811563|NCT01422408|143125709|OTHER|||||||0.5113||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.5113
71811564|NCT01422408|143125710|OTHER|||||||0.8833||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.8833
71811565|NCT01422408|143125711|OTHER|||||||0.7983||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.7983
71811566|NCT01422408|143125712|OTHER|||||||0.4937||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.4937
71811567|NCT01422408|143125713|OTHER|||||||0.9106||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.9106
71811568|NCT01422408|143125714|OTHER|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.507
71811569|NCT01422408|143125715|OTHER|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.3676
71844355|NCT02307682|143202444|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.6|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.3|-4.6|
71677366|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.216|||||TWO_SIDED|95.0|0.92|1.606||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.606|0.920|
71811570|NCT01422408|143125716|OTHER|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.6023
71811571|NCT01422408|143125717|OTHER|||||||0.08531||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.08531
71811572|NCT01422408|143125718|OTHER|||||||0.2011||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.2011
71844356|NCT02307682|143202444|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.6|-3.9|
71844357|NCT02307682|143202444|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-4.0|
71844358|NCT02307682|143202444|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-3.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.2|-3.8|
71844359|NCT02307682|143202444|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-4.5|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.6|-4.5|
71844360|NCT02307682|143202444|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-3.8|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.8|-3.8|
71844361|NCT02307682|143202444|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-2.9|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.3|-2.9|
71844362|NCT02307682|143202444|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.8|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||7.9|-2.8|
71895683|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
71844363|NCT02307682|143202444|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.5|-5.5|
71844364|NCT02307682|143202444|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.1|5.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.3|-5.1|
71844365|NCT02307682|143202444|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.3|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||6.7|-4.3|
71895684|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.98|1.32|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.32|0.98|
71895685|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.62|0.81|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.81|0.62|
71895686|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
71895687|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
71895688|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.47|0.76|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.76|0.47|
71895689|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
71895690|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.30|0.96|
71895691|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.02|0.75|
71895692|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
71895693|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.32|0.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.46|0.32|
71895694|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|0.94|1.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.75|0.94|
71895695|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
71895696|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.14|1.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.60|1.14|
71895697|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.2|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.20|
71676718|NCT01167881|142871273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.46|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|97.5|-4.87|-4.05||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.05|-4.87|<0.0001
71895698|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
71895699|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.26|4.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.30|2.26|
71844366|NCT02307682|143202444|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-5.2|
71844367|NCT02307682|143202444|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-4.6|
71844368|NCT02307682|143202444|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-4.7|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.3|-4.7|
71844369|NCT02307682|143202444|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
71844370|NCT02307682|143202444|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.8|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.2|-4.8|
71844371|NCT02307682|143202444|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.7|-3.1|
71844372|NCT02307682|143202444|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.9|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||8.7|-2.9|
71844373|NCT02307682|143202444|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.5|
71844374|NCT02307682|143202444|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.6|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.4|-4.6|
71895700|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.0|||||TWO_SIDED|95.0|1.53|2.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.75|1.53|
71895701|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
71844375|NCT02307682|143202444|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-4.5|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.9|-4.5|
71844376|NCT02307682|143202444|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-4.5|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.4|-4.5|
71844377|NCT02307682|143202444|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-3.1|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||8.7|-3.1|
71844378|NCT02307682|143202444|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-4.7|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.2|-4.7|
71844379|NCT02307682|143202445|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-7.7|
71844380|NCT02307682|143202445|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.8|-8.5|
71676719|NCT01167881|142871274|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.2|-0.01|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|<0.0001
71676720|NCT01167881|142871274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.04||0.0153|TWO_SIDED|97.5|-0.2|-0.01||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-0.01|-0.20|0.0153
71676721|NCT01167881|142871275|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.102|||<|0.0001|TWO_SIDED|97.5|0.06|0.173||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||0.173|0.060|<0.0001
71844381|NCT02307682|143202445|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.9|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.6|-8.9|
71844382|NCT02307682|143202445|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.6|-7.7|
71844383|NCT02307682|143202445|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.9|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-8.9|
71844384|NCT02307682|143202445|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.0|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.0|-10.0|
71844385|NCT02307682|143202445|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.3|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.5|-6.3|
71844386|NCT02307682|143202445|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.4|-6.2|
71844387|NCT02307682|143202445|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-10.4|2.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.0|-10.4|
71844388|NCT02307682|143202445|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.4|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-9.4|
71844389|NCT02307682|143202445|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.6|6.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.9|-4.6|
71844390|NCT02307682|143202445|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||5.7|-6.6|
71844391|NCT02307682|143202445|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.5|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.7|-6.5|
71811573|NCT01422408|143125719|OTHER|||||||0.1187||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.||||0.1187
71811574|NCT00724152|143125741|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.||||<0.05
71811575|NCT02220894|143125781|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.86||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).|||0.86|0.58|0.0003
71811576|NCT02220894|143125782|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0012|TWO_SIDED|95.0|0.65|0.91||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.91|0.65|0.0012
71811577|NCT02220894|143125783|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0013|TWO_SIDED|95.0|0.71|0.93||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||0.93|0.71|0.0013
71811578|NCT02220894|143125784|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.026|TWO_SIDED|95.0|0.69|1.0||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).|||1.00|0.69|0.0260
71811579|NCT02220894|143125785|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2134|TWO_SIDED|95.0|0.8|1.1||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.10|0.80|0.2134
71811580|NCT02220894|143125786|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7964|TWO_SIDED|95.0|0.93|1.19||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||1.19|0.93|0.7964
71811581|NCT02220894|143125787|SUPERIORITY||Difference in Percentage (DP)|7.0||||0.0353|TWO_SIDED|95.0|-0.6|14.6||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).|||14.6|-0.6|0.0353
71811582|NCT02220894|143125788|SUPERIORITY||Difference in Percentage (DP)|4.6||||0.0744|TWO_SIDED|95.0|-1.7|10.9||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||10.9|-1.7|0.0744
71811583|NCT02220894|143125789|SUPERIORITY||Difference in Percentage (DP)|0.6||||0.406|TWO_SIDED|95.0|-4.2|5.4||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages \>0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen \& Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).|||5.4|-4.2|0.4060
71811584|NCT03017079|143125851|NON_INFERIORITY|a:0.05;β：0.01 P=.046||||||0.05|||||||t-test, 2 sided|||P=.046||||0.05
71811585|NCT03017079|143125852|NON_INFERIORITY|a 0.05|Odds Ratio (OR)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71811586|NCT03017079|143125853|SUPERIORITY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
71811587|NCT03017079|143125855|NON_INFERIORITY|According to the rule of a=0.05, P\<0.05 means that the hypothesis was true|||||<|0.05|||||||Chi-squared, Corrected|||||||<0.05
71811588|NCT03092375|143125867|OTHER|Study is not intended to be powered|Mean Difference (Final Values)|-0.76|||||TWO_SIDED|95.0|-9.48|5.12|||||Excludes re-infection and death|The difference in the percentage of subjects with on-treatment virologic failure (Defined as increase of \>1 log10 IU/mL above nadir during treatment, or HCV RNA \>= 15 IU/mL at end of treatment with at least 6 weeks of treatment between Arms A and B are summarized with two-sided 95% Wilson score intervals.||5.12|-9.48|
71811589|NCT03092375|143125868|OTHER|The difference in the percentage of subjects with post-treatment relapse between Arms A and B are summarized with two-sided 95% Wilson score intervals.|Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-10.49|5.49||||||||5.49|-10.49|
71844392|NCT02307682|143202445|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.9|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.4|-4.9|
71844393|NCT02307682|143202445|OTHER||Difference in proportions|1.6|||||TWO_SIDED|95.0|-3.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||7.5|-3.9|
71811590|NCT03092375|143125869|OTHER|Difference in percentage of subjects with on-treatment virologic failure between Arms C and D will be summarized with two-sided 95% Wilson score intervals|Mean Difference (Final Values)|9.52|||||TWO_SIDED|95.0|-3.03|22.08||||||||22.08|-3.03|
71811591|NCT03092375|143125870|OTHER||Mean Difference (Final Values)|-1.81|||||TWO_SIDED|95.0|-13.85|10.22||||||Excludes re-infection and death||10.22|-13.85|
71811592|NCT03092375|143125871|OTHER|Study was not powered to compare efficacy|Logistic Regression Contrast Estimate|-0.812||||0.161|TWO_SIDED|95.0|-1.947|0.323|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Comparison of Arm Pair A/C versus B/D overall on mITT population|||0.323|-1.947|0.161
71811593|NCT03092375|143125871|OTHER|Study is not powered to compare efficacy of 12 wks vs 16 weeks of treatment|Logistic regression contrast estimate|0.89||||0.89|TWO_SIDED|95.0|-1.239|1.076|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Difference in proportion of SVR12 rates for 12 vs 16 weeks on mITT Comparing Cirrhotic subjects versus non-cirrhotic subjects.|||1.076|-1.239|0.890
71811594|NCT03092375|143125871|OTHER|Study is not powered|Logistic regression contrast estimate|0.977||||0.265|TWO_SIDED|95.0|-0.74|2.694|||Chi-squared|||Comparison of 12 weeks vs 16 weeks in Genotype 1b vs non-1b||2.694|-0.740|0.265
71811595|NCT02293395|143125889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.584|TWO_SIDED|95.0|0.8|1.5|||Log Rank|||||1.5|0.8|0.584
71811596|NCT00224770|143125913|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|6.6||0.324|ONE_SIDED|95.0||16.2|||Fisher Exact|One-sided test|MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.||16.2||0.324
71811597|NCT00224770|143125913|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|8.2||0.633|ONE_SIDED|95.0||11.2|||Fisher Exact|One-sided test|ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.||11.2||0.633
71811598|NCT00224770|143125914|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.6|STANDARD_ERROR_OF_MEAN|3.1||0.174|ONE_SIDED|95.0||11.7|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.||11.7||0.174
71811599|NCT00224770|143125915|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.437|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.||1.5||0.437
71811600|NCT00224770|143125915|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||1.5|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.||1.5||0.750
71811601|NCT00224770|143125916|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2|STANDARD_ERROR_OF_MEAN|3.9||0.409|ONE_SIDED|95.0||9.6|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.||9.6||0.409
71811602|NCT00224770|143125916|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|2.4||0.75|ONE_SIDED|95.0||2.2|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.||2.2||0.750
71811603|NCT00224770|143125917|SUPERIORITY_OR_OTHER|||||||0.468|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.468
71811604|NCT00224770|143125917|SUPERIORITY_OR_OTHER|||||||0.294|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.294
71811605|NCT00224770|143125918|SUPERIORITY_OR_OTHER|||||||0.395|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.395
71811606|NCT00224770|143125918|SUPERIORITY_OR_OTHER|||||||0.175|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.||||0.175
71811607|NCT00224770|143125919|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
71811608|NCT00224770|143125919|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.||||<0.0001
71844394|NCT02307682|143202445|OTHER||Difference in proportions|5.1|||||TWO_SIDED|95.0|-1.0|11.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||11.5|-1.0|
71895702|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.7|||||TWO_SIDED|95.0|1.97|3.7|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.70|1.97|
71895703|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.9|||||TWO_SIDED|95.0|1.99|4.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||4.29|1.99|
71895704|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
71895705|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.18|1.78|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.78|1.18|
71895706|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.04|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.04|
71895707|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
71895708|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.29|0.96|
71895709|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.89|1.2|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.20|0.89|
71811609|NCT00224770|143125920|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign test|Two-sided test||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||<0.0001
71811610|NCT00224770|143125920|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Sign test|Two-sided||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.||||0.791
71811611|NCT00224770|143125921|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|9.5||0.189|ONE_SIDED|95.0||26.6|||Fisher Exact|One-sided test|MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.||26.6||0.189
71895710|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
71895711|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.4|||||TWO_SIDED|95.0|1.24|1.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.61|1.24|
71895712|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.96|1.27|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.27|0.96|
71811612|NCT00224770|143125921|SUPERIORITY_OR_OTHER||Risk Difference (RD)|19.2|STANDARD_ERROR_OF_MEAN|14.9||0.156|ONE_SIDED|95.0||43.7|||Fisher Exact|One-sided test|ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.||43.7||0.156
71811613|NCT01106430|143125922|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.001||95.0|||||Peto-Peto-Prentice Wilcoxon Test|||||||=0.001
71895713|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rises|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
71895714|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.82|2.88|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.88|1.82|
71811614|NCT01106430|143125923|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.1||||0.001|TWO_SIDED|95.0|7.5|28.7|||Cochran-Mantel-Haenszel|||||28.7|7.5|0.001
71811615|NCT01106430|143125924|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.5|||<|0.001|TWO_SIDED|95.0|-9.3|-3.6|||ANCOVA|||||-3.6|-9.3|<0.001
71844395|NCT02307682|143202445|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.4|-8.5|
71844396|NCT02307682|143202445|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-6.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||6.4|-6.0|
71844397|NCT02307682|143202445|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.2|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||6.4|-5.2|
71844398|NCT02307682|143202445|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.0|-7.4|
71844399|NCT02307682|143202445|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.5|-8.8|
71844400|NCT02307682|143202445|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.4|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-8.4|
71844401|NCT02307682|143202445|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.5|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.3|-9.5|
71844402|NCT02307682|143202445|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.6|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.6|-8.6|
71844403|NCT02307682|143202445|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-8.8|
71844404|NCT02307682|143202445|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.1|-6.8|
71844405|NCT02307682|143202445|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.9|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.1|-5.9|
71844406|NCT02307682|143202445|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.0|-6.6|
71844407|NCT02307682|143202445|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-5.7|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.4|-5.7|
71811616|NCT01106430|143125925|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.046|TWO_SIDED|95.0|-0.17|0.0|||ANCOVA|||||-0.00|-0.17|0.046
71811617|NCT00861614|143125930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0127|TWO_SIDED|95.0|0.71|0.96|||Log Rank||Ipilimumab over placebo|||0.96|0.71|0.0127
71811618|NCT00861614|143125932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.61|0.82|||||Ipilimumab over placebo|||0.82|0.61|
71811619|NCT00861614|143125934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.02|4.0|||||Ipilimumab over placebo|||4.00|0.02|
71811620|NCT00944658|143125952|SUPERIORITY|||||||0.139|||||||ANCOVA|||||||0.139
71811621|NCT00944658|143125953|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
71811622|NCT00944658|143125954|SUPERIORITY|||||||0.108|||||||ANCOVA|Rank Ancova||||||0.108
71811623|NCT01255592|143125956|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.31||||0.004|TWO_SIDED|90.0|0.17|0.59|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.59|0.17|0.004
71811624|NCT01255592|143125957|SUPERIORITY_OR_OTHER||Ratio of AZD5069 80 mg to placebo|0.64||||0.008|TWO_SIDED|90.0|0.49|0.84|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.||0.84|0.49|0.008
71811625|NCT01255592|143125958|SUPERIORITY_OR_OTHER||LS mean difference|6.78|STANDARD_ERROR_OF_MEAN|3.298||0.047|TWO_SIDED|90.0|1.22|12.33|||ANCOVA|||The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.||12.33|1.22|0.047
71811626|NCT01255592|143125959|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.284|TWO_SIDED|90.0|-0.05|0.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.26|-0.05|0.284
71811627|NCT01255592|143125960|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.078||0.929|TWO_SIDED|90.0|-0.12|0.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.14|-0.12|0.929
71811628|NCT01255592|143125961|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.062||0.966|TWO_SIDED|90.0|-0.11|0.1|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.10|-0.11|0.966
71811629|NCT01255592|143125962|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.791|TWO_SIDED|90.0|-0.13|0.17|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.17|-0.13|0.791
71811630|NCT01255592|143125963|SUPERIORITY_OR_OTHER||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.433|TWO_SIDED|90.0|-1.6|0.6|||ANCOVA|||The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.||0.6|-1.6|0.433
71811631|NCT01255592|143125964|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|8.03||0.935|TWO_SIDED|90.0|-12.81|14.13|||ANCOVA|||Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||14.13|-12.81|0.935
71811632|NCT01255592|143125964|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|7.35||0.654|TWO_SIDED|90.0|-9.02|15.64|||ANCOVA|||Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||15.64|-9.02|0.654
71811633|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.329|TWO_SIDED|90.0|-0.09|0.36|||ANCOVA|||Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.36|-0.09|0.329
71811634|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.664|TWO_SIDED|90.0|-0.16|0.27|||ANCOVA|||How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.27|-0.16|0.664
71811635|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.152|TWO_SIDED|90.0|-0.04|0.54|||ANCOVA|||Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.54|-0.04|0.152
71811636|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.25||0.15|TWO_SIDED|90.0|-0.8|0.05|||ANCOVA|||What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.05|-0.80|0.150
71811637|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.248|TWO_SIDED|90.0|-0.06|0.35|||ANCOVA|||The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.35|-0.06|0.248
71811638|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.053|TWO_SIDED|90.0|-0.45|-0.04|||ANCOVA|||Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||-0.04|-0.45|0.053
71811639|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.179|TWO_SIDED|90.0|-0.04|0.42|||ANCOVA|||How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.42|-0.04|0.179
71811640|NCT01255592|143125965|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.942|TWO_SIDED|90.0|-0.75|0.68|||ANCOVA|||Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.68|-0.75|0.942
71811641|NCT01255592|143125966|SUPERIORITY_OR_OTHER||LS mean difference|-1.66|STANDARD_ERROR_OF_MEAN|3.374||0.625|TWO_SIDED|90.0|-7.32|4.0|||ANCOVA|||Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.00|-7.32|0.625
71811642|NCT01255592|143125966|SUPERIORITY_OR_OTHER||LS mean difference|-4.88|STANDARD_ERROR_OF_MEAN|3.342||0.151|TWO_SIDED|90.0|-10.49|0.74|||ANCOVA|||Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||0.74|-10.49|0.151
71811643|NCT01255592|143125966|SUPERIORITY_OR_OTHER||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|4.524||0.773|TWO_SIDED|90.0|-8.91|6.28|||ANCOVA|||Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.28|-8.91|0.773
71811644|NCT01255592|143125966|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|3.845||0.92|TWO_SIDED|90.0|-6.84|6.07|||ANCOVA|||Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.07|-6.84|0.920
71811645|NCT01255592|143125967|SUPERIORITY_OR_OTHER||Ratio of LS means|0.69||||0.22|TWO_SIDED|90.0|0.42|1.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.14|0.42|0.220
71811646|NCT01255592|143125968|SUPERIORITY_OR_OTHER||Ratio of LS means|4.46|||<|0.001|TWO_SIDED|90.0|3.05|6.54|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||6.54|3.05|<0.001
71811647|NCT01255592|143125969|SUPERIORITY_OR_OTHER||Ratio of LS means|0.92||||0.67|TWO_SIDED|90.0|0.68|1.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.26|0.68|0.670
71811648|NCT01255592|143125970|SUPERIORITY_OR_OTHER||Ratio of LS means|0.99||||0.968|TWO_SIDED|90.0|0.78|1.27|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.27|0.78|0.968
71811649|NCT01255592|143125971|SUPERIORITY_OR_OTHER||Ratio of LS means|1.43||||0.193|TWO_SIDED|90.0|0.91|2.24|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.24|0.91|0.193
71811650|NCT01255592|143125972|SUPERIORITY_OR_OTHER||Ratio of LS means|3.24|||<|0.001|TWO_SIDED|90.0|2.19|4.79|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||4.79|2.19|<0.001
71811651|NCT01255592|143125973|SUPERIORITY_OR_OTHER||Ratio of LS means|1.02||||0.917|TWO_SIDED|90.0|0.71|1.48|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.48|0.71|0.917
71811652|NCT01255592|143125974|SUPERIORITY_OR_OTHER||Ratio of LS means|0.17||||0.111|TWO_SIDED|90.0|0.03|1.08|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.08|0.03|0.111
71811653|NCT01255592|143125975|SUPERIORITY_OR_OTHER||Ratio of LS means|1.33||||0.367|TWO_SIDED|90.0|0.79|2.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.26|0.79|0.367
71811654|NCT01255592|143125976|SUPERIORITY_OR_OTHER||Ratio of LS means|1.54||||0.112|TWO_SIDED|90.0|0.98|2.4|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||2.40|0.98|0.112
71811655|NCT01255592|143125977|SUPERIORITY_OR_OTHER||Ratio of LS means|1.05||||0.241|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.12|0.98|0.241
71811656|NCT01255592|143125978|SUPERIORITY_OR_OTHER||Ratio of LS means|5.5|||<|0.001|TWO_SIDED|90.0|4.18|7.23|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||7.23|4.18|<0.001
71811657|NCT01255592|143125979|SUPERIORITY_OR_OTHER||Ratio of LS means|1.16||||0.281|TWO_SIDED|90.0|0.92|1.47|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.47|0.92|0.281
71811658|NCT01255592|143125980|SUPERIORITY_OR_OTHER||Ratio of LS means|1.56||||0.001|TWO_SIDED|90.0|1.28|1.91|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||1.91|1.28|0.001
71844408|NCT02307682|143202445|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.1|-9.0|
71811659|NCT01255592|143125981|SUPERIORITY_OR_OTHER||Ratio of LS means|6.07|||<|0.001|TWO_SIDED|90.0|4.42|8.35|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.||8.35|4.42|<0.001
71811660|NCT01493687|143126018|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71811661|NCT01493687|143126019|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.13|||<|0.001|TWO_SIDED|95.0|-10.12|-6.13|||ANCOVA|||||-6.13|-10.12|<0.001
71811662|NCT01493687|143126020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71811663|NCT02323646|143126021|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
71811664|NCT02323646|143126021|SUPERIORITY|||||||0.0063|||||||Fisher Exact|||||||0.0063
71811665|NCT02323646|143126022|SUPERIORITY|||||||0.0237|||||||Fisher Exact|||||||0.0237
71811666|NCT02323646|143126022|SUPERIORITY|||||||0.0272|||||||Fisher Exact|||||||0.0272
71811667|NCT02323646|143126023|SUPERIORITY|||||||0.0145|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0145
71811668|NCT02323646|143126023|SUPERIORITY|||||||0.0662|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.||||0.0662
71811669|NCT02323646|143126023|SUPERIORITY|||||||0.0061|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0061
71811670|NCT02323646|143126023|SUPERIORITY|||||||0.0296|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.||||0.0296
71811671|NCT02323646|143126024|SUPERIORITY|||||||0.2642|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2642
71811672|NCT02323646|143126024|SUPERIORITY|||||||0.4383|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.4383
71811673|NCT02323646|143126024|SUPERIORITY|||||||0.5333|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5333
71811674|NCT02323646|143126024|SUPERIORITY|||||||0.8791|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8791
71811675|NCT02323646|143126024|SUPERIORITY|||||||0.3666|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3666
71811676|NCT02323646|143126024|SUPERIORITY|||||||0.345|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up||||0.3450
71811677|NCT02323646|143126025|SUPERIORITY|||||||0.0473|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0473
71811678|NCT02323646|143126025|SUPERIORITY|||||||0.0191|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0191
71811679|NCT02323646|143126025|SUPERIORITY|||||||0.0749|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0749
71811680|NCT02323646|143126025|SUPERIORITY|||||||0.0233|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0233
71844409|NCT02307682|143202445|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.2|5.5||Hypothesis testing not pre-specified.|Regression, Logistic|||Week 64||5.5|-7.2|
71844410|NCT02307682|143202445|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.6|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.7|-6.6|
71895715|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.18|1.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.90|1.18|
71895716|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
71895717|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.63|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.85|0.63|
71895718|NCT01025336|143313922|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|0.99|1.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.51|0.99|
71811681|NCT02323646|143126025|SUPERIORITY|||||||0.7569|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7569
71895719|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
71895720|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.16|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.16|0.91|
71895721|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
71895722|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.91|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.13|0.91|
71895723|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
71895724|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.82|3.24|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.24|1.82|
71811682|NCT02323646|143126025|SUPERIORITY|||||||0.5399|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5399
71844411|NCT02307682|143202445|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-4.3|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.3|-4.3|
71844412|NCT02307682|143202445|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.3|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.1|-6.3|
71844413|NCT02307682|143202445|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-7.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.6|-7.2|
71844414|NCT02307682|143202445|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.5|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-8.5|
71844415|NCT02307682|143202445|OTHER||Difference in proportions|4.0|||||TWO_SIDED|95.0|-2.4|10.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||10.2|-2.4|
71811683|NCT02323646|143126026|SUPERIORITY|||||||0.1683|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1683
71811684|NCT02323646|143126026|SUPERIORITY|||||||0.256|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.2560
71844416|NCT02307682|143202445|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-5.1|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.8|-5.1|
71844417|NCT02307682|143202445|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-2.5|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.6|-2.5|
71895725|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
71811685|NCT02323646|143126026|SUPERIORITY|||||||0.4997|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.4997
71811686|NCT02323646|143126026|SUPERIORITY|||||||0.1334|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.1334
71811687|NCT02323646|143126026|SUPERIORITY|||||||0.0323|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.0323
71811688|NCT02323646|143126026|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
71811689|NCT02323646|143126027|SUPERIORITY|||||||0.6356|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.6356
71811690|NCT02323646|143126027|SUPERIORITY|||||||0.9539|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9539
71844418|NCT02307682|143202445|OTHER||Difference in proportions|2.4|||||TWO_SIDED|95.0|-3.5|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||9.0|-3.5|
71844419|NCT02307682|143202445|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-3.0|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||9.0|-3.0|
71844420|NCT02307682|143202445|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||6.4|-5.8|
71844421|NCT02307682|143202445|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-6.6|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.5|-6.6|
71844422|NCT02307682|143202445|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-6.0|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||6.1|-6.0|
71844423|NCT02307682|143202445|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-2.8|9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||9.5|-2.8|
71844424|NCT02307682|143202445|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-4.3|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-4.3|
71844425|NCT02307682|143202445|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.7|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||7.8|-4.7|
71844426|NCT02307682|143202445|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||9.0|-3.8|
71844427|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-7.9|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-24.2|8.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||8.4|-24.2|
71844428|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-16.5|STANDARD_ERROR_OF_MEAN|7.86|||TWO_SIDED|95.0|-31.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-1.1|-31.9|
71844429|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-13.7|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-30.4|3.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||3.0|-30.4|
71844430|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-19.0|STANDARD_ERROR_OF_MEAN|8.16|||TWO_SIDED|95.0|-35.0|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-2.9|-35.0|
71844431|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-19.7|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.3|-3.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||-3.1|-36.3|
71844432|NCT02307682|143202446|OTHER||Least Squares Mean Difference|-24.5|STANDARD_ERROR_OF_MEAN|8.24|||TWO_SIDED|95.0|-40.7|-8.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-8.3|-40.7|
71811691|NCT02323646|143126027|SUPERIORITY|||||||0.5219|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5219
71811692|NCT02323646|143126027|SUPERIORITY|||||||0.2678|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.2678
71811693|NCT02323646|143126027|SUPERIORITY|||||||0.3086|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3086
71811694|NCT02323646|143126027|SUPERIORITY|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.3847
71811695|NCT02323646|143126028|SUPERIORITY|||||||0.8393|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8393
71811696|NCT02323646|143126028|SUPERIORITY|||||||0.1361|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1361
71811697|NCT02323646|143126028|SUPERIORITY|||||||0.0382|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0382
71676722|NCT01167881|142871276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.6|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.0|-4.2||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-4.2|-7.0|<0.0001
71811698|NCT02323646|143126028|SUPERIORITY|||||||0.6273|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.6273
71811699|NCT02323646|143126028|SUPERIORITY|||||||0.8237|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.8237
71811700|NCT02323646|143126028|SUPERIORITY|||||||0.137|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.1370
71811701|NCT02323646|143126029|SUPERIORITY|||||||0.7949|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.7949
71811702|NCT02323646|143126029|SUPERIORITY|||||||0.1928|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1928
71811703|NCT02323646|143126029|SUPERIORITY|||||||1|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||1.0000
71811704|NCT02323646|143126029|SUPERIORITY|||||||0.392|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3920
71811705|NCT02323646|143126029|SUPERIORITY|||||||0.541|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.5410
71811706|NCT02323646|143126029|SUPERIORITY|||||||0.4602|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4602
71811707|NCT02323646|143126030|SUPERIORITY|||||||0.9536|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.9536
71811708|NCT02323646|143126030|SUPERIORITY|||||||0.1355|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1355
71811709|NCT02323646|143126030|SUPERIORITY|||||||0.9396|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9396
71811710|NCT02323646|143126030|SUPERIORITY|||||||0.9102|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.9102
71811711|NCT02323646|143126030|SUPERIORITY|||||||0.6266|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6266
71811712|NCT02323646|143126030|SUPERIORITY|||||||0.9302|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.9302
71811713|NCT02323646|143126031|SUPERIORITY|||||||0.817|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8170
71811714|NCT02323646|143126031|SUPERIORITY|||||||0.8177|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.8177
71811715|NCT02323646|143126031|SUPERIORITY|||||||0.3167|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.3167
71811716|NCT02323646|143126031|SUPERIORITY|||||||0.5503|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.5503
71811717|NCT02323646|143126031|SUPERIORITY|||||||0.6929|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.6929
71811718|NCT02323646|143126031|SUPERIORITY|||||||0.726|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7260
71811719|NCT02323646|143126032|SUPERIORITY|||||||0.3896|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.3896
71811720|NCT02323646|143126032|SUPERIORITY|||||||0.1358|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1358
71811721|NCT02323646|143126032|SUPERIORITY|||||||0.7903|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.7903
71811722|NCT02323646|143126032|SUPERIORITY|||||||0.8206|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8206
71811723|NCT02323646|143126032|SUPERIORITY|||||||0.7891|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.7891
71811724|NCT02323646|143126032|SUPERIORITY|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit||||0.4010
71811725|NCT02323646|143126033|SUPERIORITY|||||||0.0294|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.0294
71811726|NCT02323646|143126033|SUPERIORITY|||||||0.1934|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1||||0.1934
71811727|NCT02323646|143126033|SUPERIORITY|||||||0.0442|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.0442
71811728|NCT02323646|143126033|SUPERIORITY|||||||0.8314|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2||||0.8314
71811729|NCT00089141|143126038|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.22||95.0|0.7|3.7||P values are 2 sided and are based on likelihood ratio statistics.|Regression, Cox|Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.|For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.|||3.7|0.7|.22
71811730|NCT00089141|143126039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.65||||0.03||95.0|1.1|2.6|||Regression, Cox|Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).||||2.6|1.1|.03
71811731|NCT00089141|143126040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.55||95.0|0.7|2.1|||Regression, Cox|||||2.1|0.7|.55
71811732|NCT00089141|143126041|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.48||95.0|0.4|6.0|||Regression, Cox|||||6.0|0.4|.48
71811733|NCT00089141|143126042|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.17||95.0|0.8|3.9|||Regression, Cox|adjusted for risk category||||3.9|0.8|.17
71811734|NCT00089141|143126043|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.41||95.0|0.5|5.0|||Regression, Cox|||||5.0|0.5|.41
71811735|NCT00089141|143126044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.69||||0.14||95.0|0.9|3.2|||Regression, Cox|||||3.2|0.9|.14
71811736|NCT00089141|143126045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.99||||0.1||95.0|0.9|4.3|||Regression, Cox|||||4.3|0.9|.10
71811737|NCT00089141|143126046|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.34||95.0|0.08|2.1|||Regression, Cox|||||2.1|.08|.34
71811738|NCT00089141|143126047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.28||95.0|0.7|3.2|||Regression, Cox|||||3.2|0.7|.28
71811739|NCT00180479|143126053|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.|||||<|0.0001|||||||t-test, 1 sided|||Primary endpoint analyzed for intent-to-treat \& per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.||||<0.0001
71844433|NCT02307682|143202446|SUPERIORITY||Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|9.24||0.0159|TWO_SIDED|95.0|-38.0|-1.7||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||-1.7|-38.0|0.0159
71844434|NCT02307682|143202446|SUPERIORITY||Least Squares Mean Difference|-27.8|STANDARD_ERROR_OF_MEAN|8.8||0.0008|TWO_SIDED|95.0|-45.1|-10.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-10.5|-45.1|0.0008
71844435|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|8.69|||TWO_SIDED|95.0|-11.8|22.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||22.3|-11.8|
71844436|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-14.1|20.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||20.5|-14.1|
71844437|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-25.8|STANDARD_ERROR_OF_MEAN|9.44|||TWO_SIDED|95.0|-44.3|-7.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||-7.2|-44.3|
71844438|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-29.6|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-47.5|-11.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-11.6|-47.5|
71844439|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-11.6|STANDARD_ERROR_OF_MEAN|8.96|||TWO_SIDED|95.0|-29.2|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||5.9|-29.2|
71844440|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|8.98|||TWO_SIDED|95.0|-29.8|5.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||5.5|-29.8|
71844441|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-20.1|STANDARD_ERROR_OF_MEAN|9.91|||TWO_SIDED|95.0|-39.6|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||-0.7|-39.6|
71844442|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-42.1|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-4.2|-42.1|
71844443|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-35.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||0.7|-35.5|
71844444|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-19.6|STANDARD_ERROR_OF_MEAN|9.14|||TWO_SIDED|95.0|-37.6|-1.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-1.7|-37.6|
71844445|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|9.83|||TWO_SIDED|95.0|-46.6|-8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||-8.0|-46.6|
71677367|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.818|||||TWO_SIDED|95.0|0.619|1.081||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.081|0.619|
71811740|NCT00180479|143126054|NON_INFERIORITY_OR_EQUIVALENCE|Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.|||||<|0.0001|||||||t-test, 1 sided|||Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.||||<0.0001
71811741|NCT05131165|143126097|SUPERIORITY|||||||0.056||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.056
71811742|NCT05131165|143126097|SUPERIORITY|||||||0.062||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.062
71811743|NCT05131165|143126098|SUPERIORITY|||||||0.364||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.364
71811744|NCT05131165|143126098|SUPERIORITY|||||||0.409||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.409
71811745|NCT05131165|143126099|SUPERIORITY|||||||0.158||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.158
71811746|NCT05131165|143126099|SUPERIORITY|||||||0.017||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.017
71811747|NCT05131165|143126100|SUPERIORITY|||||||0.654||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.654
71811748|NCT05131165|143126100|SUPERIORITY|||||||0.035||||||A priori threshold for statistical significance (alpha) = 0.05|ANCOVA|||The analyses utilized control as the reference group, and thus, the values reported include control mean and standard error as the reference value (derived from an ordinary least squared regression without controls). The results for the intervention groups are derived from the multiple regression model that controlled for other participant characteristics, including demographics, intrinsic motivation and habit strength at baseline.||||0.035
71811749|NCT05131165|143126102|SUPERIORITY|||||||0.5468|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5468
71811750|NCT05131165|143126102|SUPERIORITY|||||||0.5255|||||||t-test, 2 sided|||The analyses compared the change in viral suppression status of the participants from baseline to month 9. For each participant, we derived the change in viral suppression status by subtracting two binary variables - one indicating whether the participant was virally suppressed at baseline (based on their chart records from around 3 months prior to baseline) and the other indicating whether the participant was virally suppressed at around month 9 of the study.||||0.5255
71844446|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-48.2|-10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-10.9|-48.2|
71844447|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-9.3|STANDARD_ERROR_OF_MEAN|9.27|||TWO_SIDED|95.0|-27.5|8.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||8.9|-27.5|
71895726|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.54|2.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.09|1.54|
71895727|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
71895728|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.48|2.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.55|1.48|
71895729|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
71895730|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.5|2.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.51|1.50|
71895731|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
71895732|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.31|2.18|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.18|1.31|
71811751|NCT02298361|143126122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76|||||TWO_SIDED|95.0|1.6|1.93|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||1.93|1.60|
71811752|NCT02298361|143126122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|1.91|2.72|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||2.72|1.91|
71811753|NCT02298361|143126123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.53|0.94|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)|||0.94|0.53|
71811754|NCT02298361|143126123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.45|0.67|||Generalized estimating equation|GEE model clustered by clinic, adjusted for demographics, number of visits, new/established patient at first visit, and household factors.|Adjusted odds of losing Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)|||0.67|0.45|
71895733|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
71895734|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.4|||||TWO_SIDED|95.0|1.76|3.38|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.38|1.76|
71895735|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
71895736|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.38|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.01|1.38|
71895737|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
71676723|NCT01167881|142871277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.5|-1.8||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~1. Non-inferiority in HbA1c change from baseline at 104 weeks,~2. Superiority in body weight change from baseline at 104 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~4. Superiority in HbA1c change from baseline at 104 weeks,~5. Superiority in systolic blood pressure change from baseline at 104 weeks,~6. Superiority in diastolic blood pressure change from baseline at 104 weeks."||-1.8|-3.5|<0.0001
71676724|NCT01167881|142871278|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|97.5|-0.16|0.02|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.02|-0.16|<0.0001
71811755|NCT02459262|143126136|OTHER|ANOVA repeated measures: In-transformed antibody concentrations as dependent variable; dose level, time, presence of adjuvant and dose\*time interaction as fixed effects; subjects as random effects||||||0.0193||||||Adjuvant effect at Day 85, the primary immunological endpoint|ANOVA|Adjuvant effect, with higher antibody concentration values after all dose levels of vaccine was significant at all time points (D29, D43, D57, Day 85)||The objectives for Part A were to evaluate the effect of adjuvant and to inform the selection of dose levels for Part B. The study was not powered for inter-group comparisons.||||0.0193
71811756|NCT02459262|143126137|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71811757|NCT02459262|143126138|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71811758|NCT05168579|143126141|SUPERIORITY||Odds Ratio (OR)|13.8|||<|0.001|TWO_SIDED|95.0|2.76|69.6|||Mixed Models Analysis|||||69.6|2.76|<0.001
71844448|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-11.4|STANDARD_ERROR_OF_MEAN|9.64|||TWO_SIDED|95.0|-30.3|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.5|-30.3|
71844449|NCT02307682|143202446|SUPERIORITY||Least Squares Mean Difference|-23.9|STANDARD_ERROR_OF_MEAN|9.79||0.0075|TWO_SIDED|95.0|-43.1|-4.6||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-4.6|-43.1|0.0075
71844450|NCT02307682|143202446|SUPERIORITY||Least Squares Mean Difference|-29.0|STANDARD_ERROR_OF_MEAN|9.47||0.0012|TWO_SIDED|95.0|-47.6|-10.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-10.4|-47.6|0.0012
71844451|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|9.17|||TWO_SIDED|95.0|-33.6|2.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||2.4|-33.6|
71844452|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.35|||TWO_SIDED|95.0|-33.4|3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||3.3|-33.4|
71844453|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.9|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||-1.1|-38.9|
71844454|NCT02307682|143202446|OTHER||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-39.4|-0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-0.7|-39.4|
71844455|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-18.8|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.0|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||-0.5|-37.0|
71844456|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-12.7|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-31.4|6.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||6.1|-31.4|
71677368|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.85|||||TWO_SIDED|95.0|2.152|3.773||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.773|2.152|
71811759|NCT01242748|143126143|NON_INFERIORITY_OR_EQUIVALENCE|Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.|Hazard Ratio (HR)|0.774||||0.1589|TWO_SIDED|95.0|0.542|1.106|||Cox proportional hazard model|||The hazard ratio of PSA PFS failure rates was estimated using the Cox proportional hazard model with time to PSA PFS failure as dependent and treatment as independent variables and adjusted for baseline PSA category, prostate cancer stage, weight and geographical region. Degarelix was to be considered non-inferior to goserelin if the upper limit of the two-sided 95% confidence interval (CI) of the adjusted hazard ratio was less than or equal to the non-inferiority margin of 1.33.||1.106|0.542|0.1589
71811760|NCT01242748|143126144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783||||0.1244|TWO_SIDED|95.0|0.574|1.07|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.070|0.574|0.1244
71811761|NCT01242748|143126145|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.856|||||TWO_SIDED|95.0|0.58|1.263||||||The hazard ratio was estimated using the Cox proportional hazard model.||1.263|0.580|
71811762|NCT01242748|143126146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.511||||0.0005|TWO_SIDED|95.0|1.739|7.09|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||7.090|1.739|0.0005
71811763|NCT01242748|143126147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.739||||0.143|TWO_SIDED|95.0|0.493|1.108|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.108|0.493|0.143
71811764|NCT01242748|143126148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.2212|TWO_SIDED|95.0|0.259|1.368|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.||1.368|0.259|0.2212
71811765|NCT00840801|143126151|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A stratified score test was used to test the non-inferiority with a margin of -10% at 2.5% type I error (one-sided).|||||<|0.001|||||||Stratified score test|||Non-inferiority Test on Seropositive Response Rate||||<0.001
71811766|NCT02416492|143126199|SUPERIORITY||Least Square (LS) Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.9||0.0401|TWO_SIDED|95.0||||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||||0.0401
71811767|NCT02416492|143126200|SUPERIORITY||Least Square (LS) Mean Difference|-0.7||||0.1655|TWO_SIDED|95.0|-1.7|0.3||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||0.3|-1.7|0.1655
71811768|NCT02416492|143126201|SUPERIORITY||Least Square (LS) Mean Difference|2.7||||0.3398|TWO_SIDED|95.0|-2.9|8.3|||Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||8.3|-2.9|0.3398
71811769|NCT02416492|143126202|SUPERIORITY||Least Square (LS) Mean Difference|-2.6||||0.8974|TWO_SIDED|95.0|-42.2|37.1||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|||Adjusted LS mean and treatment group difference in change from baseline at Week 24 were modeled using an MMRM including the following variables: treatment, visit, treatment by visit interaction, baseline FMMS score, baseline FMMS score by visit interaction, GOS-E score at screening, and GOS-E score at screening by visit interaction.||37.1|-42.2|0.8974
71811770|NCT02416492|143126203|SUPERIORITY||Least Square (LS) Mean Difference|-0.49||||0.8534|TWO_SIDED|95.0|-5.77|4.8||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Upper Extremity Function T Score at Week 24||4.80|-5.77|0.8534
71811771|NCT02416492|143126203|SUPERIORITY||Least Square (LS) Mean Difference|0.41||||0.8443|TWO_SIDED|95.0|-3.78|4.6||MMRM: Mixed Model for Repeated Measures|Mixed Models Analysis|MMRM included treatment, visit, baseline endpoints \& GOS-E scores, baseline endpoints \& GOS-E by visit interaction, treatment-by-visit interaction||Change from Baseline in NeuroQOL Lower Extremity Function T Score at Week 24||4.60|-3.78|0.8443
71811772|NCT03286751|143126209|SUPERIORITY||Ratio of Geometric LSMeans|1.01||||0.5495|TWO_SIDED|95.0|0.974|1.05|||Mixed Models Analysis|||||1.05|0.974|0.5495
71811773|NCT03286751|143126209|SUPERIORITY||Ratio of Geometric LSMeans|1.02||||0.2236|TWO_SIDED|95.0|0.986|1.06|||Mixed Models Analysis|||||1.06|0.986|0.2236
71811774|NCT03286751|143126209|SUPERIORITY||Ratio of Geometric LSMeans|1.03||||0.0727|TWO_SIDED|95.0|0.997|1.07|||Mixed Models Analysis|||||1.07|0.997|0.0727
71811775|NCT03286751|143126210|SUPERIORITY||Ratio of Geometric LSMeans|0.97||||0.5749|TWO_SIDED|95.0|0.87|1.08|||Mixed Models Analysis|||||1.08|0.87|0.5749
71811776|NCT03286751|143126210|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1578|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1578
71811777|NCT03286751|143126210|SUPERIORITY||Ratio of Geometric LSMeans|0.92||||0.1351|TWO_SIDED|95.0|0.83|1.03|||Mixed Models Analysis|||||1.03|0.83|0.1351
71677369|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.332|||||TWO_SIDED|95.0|0.251|0.44||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.440|0.251|
71811778|NCT02231177|143126211|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|STANDARD_DEVIATION|32.15|||TWO_SIDED|90.0|0.99|1.27|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.27|0.99|
71811779|NCT02231177|143126212|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11|STANDARD_DEVIATION|27.17|||TWO_SIDED|90.0|1.01|1.22|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.22|1.01|
71811780|NCT02231177|143126213|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|STANDARD_DEVIATION|20.43|||TWO_SIDED|90.0|0.91|1.06|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||1.06|0.91|
71811781|NCT02231177|143126214|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.05|STANDARD_DEVIATION|19.85|||TWO_SIDED|90.0|0.98|1.13|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.||1.13|0.98|
71811782|NCT02231177|143126215|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.9|STANDARD_DEVIATION|19.81|||TWO_SIDED|90.0|0.83|0.98|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.||0.98|0.83|
71811783|NCT02231177|143126216|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|STANDARD_DEVIATION|29.92|||TWO_SIDED|90.0|0.87|1.07|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.07|0.87|
71811784|NCT02231177|143126217|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02|STANDARD_DEVIATION|21.33|||TWO_SIDED|90.0|0.93|1.12|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg : Olodaterol 10 µg). No formal testing.||1.12|0.93|
71811785|NCT02231177|143126218|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|STANDARD_DEVIATION|22.61|||TWO_SIDED|90.0|0.84|1.0|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.||1.00|0.84|
71811786|NCT02231177|143126219|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32|STANDARD_DEVIATION|96.12|||TWO_SIDED|90.0|0.98|1.77|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg; Olodaterol 10 µg). No formal testing.||1.77|0.98|
71811787|NCT02231177|143126220|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|STANDARD_DEVIATION|72.08|||TWO_SIDED|90.0|0.79|1.24|||ANOVA|ANOVA on the logarithmic scale with fixed effect for treatment, period, sequence, centre and random effect for subject within sequence and centre.|The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg; Tiotropium 5 µg). No formal testing.||1.24|0.79|
71811788|NCT00252538|143126249|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||All statistics employed Statistical Package for Social Science (SPSS) 17.0. Analysis of variances were used to compare viral responses in genotypes of interest, employing Scheffe's post-hoc analyses. Repeated-measure mixed-effect analyses were used to compare changes in subjective symptoms over time, including age, gender, and self identified race as covariates. Kaplan-Meier survival analyses examining time until MDD development were compared using theMantel-Cox log rank test.||||>0.05
71811789|NCT03494166|143126252|SUPERIORITY|Key parameter was the coefficient for the trial arm variable in the mixed model, reflecting average difference of group means over time (weeks 1-13).|Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.32||0.31|TWO_SIDED|95.0|-3.9|1.25||P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was set at .05.|Mixed Models Analysis|Linear mixed effects models were used for 13 repeated measures of symptom severity index, adjusting for baseline value.|The mean of the group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC (average over time).|"The null hypothesis was that the means in two arms were equal, the alternative hypothesis was that the means were not equal.~We planned to randomize 224 survivors in approximately 3:1 ratio in the first randomization; power was 0.92 to detect the adjusted d=0.54 in the comparison of the SMSH and SMSH+TIPC in the first randomization. The planned number of 224 was exceeded because more survivors than planned were determined to have high need for symptom management."||1.25|-3.90|.31
71844457|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|95.0|-46.7|-7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||-7.6|-46.7|
71677370|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.224|||||TWO_SIDED|95.0|0.169|0.296||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.296|0.169|
71844458|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-22.5|STANDARD_ERROR_OF_MEAN|9.73|||TWO_SIDED|95.0|-41.6|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-3.4|-41.6|
71844459|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-14.9|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-33.8|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||3.9|-33.8|
71844460|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-13.2|STANDARD_ERROR_OF_MEAN|9.88|||TWO_SIDED|95.0|-32.6|6.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||6.2|-32.6|
71844461|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-29.9|STANDARD_ERROR_OF_MEAN|9.89|||TWO_SIDED|95.0|-49.3|-10.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||-10.5|-49.3|
71844462|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-26.4|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-46.0|-6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-6.8|-46.0|
71844463|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|9.62|||TWO_SIDED|95.0|-38.2|-0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||-0.4|-38.2|
71844464|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-15.7|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-35.0|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||3.7|-35.0|
71844465|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-24.8|STANDARD_ERROR_OF_MEAN|10.34|||TWO_SIDED|95.0|-45.0|-4.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||-4.5|-45.0|
71844466|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|10.32|||TWO_SIDED|95.0|-43.9|-3.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-3.4|-43.9|
71844467|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.65|||TWO_SIDED|95.0|-38.4|-0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||-0.5|-38.4|
71844468|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-11.8|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|95.0|-31.5|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||8.0|-31.5|
71844469|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|10.16|||TWO_SIDED|95.0|-47.3|-7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||-7.4|-47.3|
71844470|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-24.2|STANDARD_ERROR_OF_MEAN|10.22|||TWO_SIDED|95.0|-44.3|-4.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-4.2|-44.3|
71844471|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-15.1|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-34.2|3.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||3.9|-34.2|
71844472|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-12.5|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-32.1|7.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||7.1|-32.1|
71844473|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-30.9|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-50.6|-11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-11.3|-50.6|
71844474|NCT02307682|143202446|OTHER|Treatment difference|Least Squares Mean Difference|-26.0|STANDARD_ERROR_OF_MEAN|10.28|||TWO_SIDED|95.0|-46.2|-5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-5.9|-46.2|
71844475|NCT02307682|143202447|SUPERIORITY||Least Squares Mean Difference|-19.5|STANDARD_ERROR_OF_MEAN|9.29||0.0183|TWO_SIDED|95.0|-37.7|-1.2||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-1.2|-37.7|0.0183
71844476|NCT02307682|143202447|SUPERIORITY||Least Squares Mean Difference|-22.4|STANDARD_ERROR_OF_MEAN|9.19||0.0075|TWO_SIDED|95.0|-40.4|-4.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-4.4|-40.4|0.0075
71844477|NCT02307682|143202448|OTHER|Treatment difference|Least Squares Mean Difference|-23.2|STANDARD_ERROR_OF_MEAN|9.76|||TWO_SIDED|95.0|-42.4|-4.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|||-4.1|-42.4|
71844478|NCT02307682|143202448|OTHER|Treatment difference|Least Squares Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|10.0|||TWO_SIDED|95.0|-38.3|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-38.3|
71844479|NCT02307682|143202449|OTHER|Treatment difference|Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-32.6|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48||0.7|-32.6|
71844480|NCT02307682|143202449|OTHER|Treatment difference|Least Squares Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-36.5|-3.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-3.3|-36.5|
71844481|NCT02307682|143202449|OTHER|Treatment difference|Least Squares Mean Difference|-18.9|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-36.4|-1.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96||-1.5|-36.4|
71844482|NCT02307682|143202449|OTHER|Treatment difference|Least Squares Mean Difference|-19.3|STANDARD_ERROR_OF_MEAN|8.93|||TWO_SIDED|95.0|-36.9|-1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-1.8|-36.9|
71844483|NCT02307682|143202450|OTHER|Treatment difference|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||0.1|-0.8|
71844484|NCT02307682|143202450|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-0.2|-1.0|
71844485|NCT02307682|143202450|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.1|-0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||-0.2|-1.1|
71844486|NCT02307682|143202450|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.9|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.0|-0.9|
71844487|NCT02307682|143202450|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-1.3|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||-0.3|-1.3|
71844488|NCT02307682|143202450|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-1.1|-0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-0.3|-1.1|
71895738|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.55|1.14|
71895739|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
71895740|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.28|1.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.67|1.28|
71811790|NCT03494166|143126253|SUPERIORITY|The key parameter was the coefficient for the variable reflecting trial arm from the second randomization in the mixed model. This parameter reflected average difference between means of two groups over time (weeks 5-13).|Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|3.35||0.52|TWO_SIDED|95.0|-8.91|4.55||The p-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05.|Mixed Models Analysis|Linear mixed effects models were used for 9 repeated measures of symptom severity index (weeks 5-13), adjusting for baseline value.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. The required sample size was 60 per group for .80 power or greater in two-tailed tests at the 0.05 level of significance using the effect size of Cohen's d=0.54 (adjusted for baseline and repeated measures). The actual sample size was smaller (61 total) due to the higher than planned rate of response to the SMSH alone by week 4.||4.55|-8.91|.52
71895741|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
71895742|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.53|2.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.31|1.53|
71895743|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
71895744|NCT01025336|143313923|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.24|1.84|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.84|1.24|
71811791|NCT03494166|143126254|SUPERIORITY|Key parameter was the coefficient for the trial arm from the first randomization variable in the linear regression model.|Median Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|1.12||0.71|TWO_SIDED|95.0|-2.63|1.81||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear||The mean of group that started with SMSH alone minus the mean of the group that started with SMSH+TIPC.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||1.81|-2.63|.71
71895745|NCT01025336|143313924|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.19|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.19|
71895746|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.25|0.17|
71895747|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.29|0.20|
71895748|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.2|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.30|0.20|
71895749|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.31|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.31|
71895750|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.18|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.26|0.18|
71844489|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-3.3|17.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4||17.5|-3.3|
71844490|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-10.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||10.9|-10.2|
71844491|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-8.4|12.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8||12.6|-8.4|
71844492|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|5.52|||TWO_SIDED|95.0|-12.5|9.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||9.2|-12.5|
71844493|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.38|||TWO_SIDED|95.0|-11.2|10.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12||10.0|-11.2|
71844494|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.55|||TWO_SIDED|95.0|-13.9|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||7.9|-13.9|
71844495|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-11.1|11.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16||11.4|-11.1|
71844496|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-16.1|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.5|-16.1|
71844497|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|9.3|STANDARD_ERROR_OF_MEAN|5.56|||TWO_SIDED|95.0|-1.6|20.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20||20.3|-1.6|
71844498|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.58|||TWO_SIDED|95.0|-3.4|18.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||18.5|-3.4|
71844499|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.68|||TWO_SIDED|95.0|-14.7|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||7.6|-14.7|
71844500|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-17.9|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||5.3|-17.9|
71844501|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|95.0|-8.8|12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28||12.9|-8.8|
71844502|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.7|13.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||13.8|-8.7|
71844503|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.73|||TWO_SIDED|95.0|-8.4|14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32||14.1|-8.4|
71844504|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.7|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||11.5|-11.7|
71844505|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-8.8|13.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36||13.6|-8.8|
71844506|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-12.2|10.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||10.9|-12.2|
71676725|NCT01167881|142871279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|97.5|-5.16|-4.46||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.46|-5.16|<0.0001
71676726|NCT01167881|142871280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.077|||<|0.0001|TWO_SIDED|97.5|0.04|0.148||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (\<8.5 / \>=8.5).||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||0.148|0.040|<0.0001
71676727|NCT01167881|142871281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|97.5|-7.3|-4.4||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-4.4|-7.3|<0.0001
71676728|NCT01167881|142871282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|97.5|-3.7|-2.0||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~1. Non-inferiority in HbA1c change from baseline at 52 weeks,~2. Superiority in body weight change from baseline at 52 weeks,~3. Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~4. Superiority in systolic blood pressure change from baseline at 52 weeks,~5. Superiority in diastolic blood pressure change from baseline at 52 weeks."||-2.0|-3.7|<0.0001
71676729|NCT00586820|142871332|SUPERIORITY_OR_OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
71676730|NCT00586820|142871333|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 8 hours post PCI.||||0.019
71676731|NCT00586820|142871333|SUPERIORITY_OR_OTHER|||||||0.007|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 16 hours post-PCI.||||0.007
71676732|NCT01217476|142871353|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.4039|TWO_SIDED|95.0|0.66|2.8|||Regression, Logistic|||||2.80|0.66|0.4039
71676733|NCT01217476|142871354|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.52|1.56|||Regression, Logistic|||||1.56|0.52|
71676734|NCT04223635|142871362|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Interval (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|92.6|||||TWO_SIDED|90.0|54.38|157.69|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||157.69|54.38|
71844507|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|5.71|||TWO_SIDED|95.0|-10.7|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40||11.7|-10.7|
71844508|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-15.0|7.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||7.8|-15.0|
71844509|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62|||TWO_SIDED|95.0|-6.1|15.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44||15.9|-6.1|
71844510|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.0|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||13.1|-10.0|
71844511|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-10.5|12.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||12.1|-10.5|
71844512|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.93|||TWO_SIDED|95.0|-12.2|11.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||11.1|-12.2|
71895751|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
71895752|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.12|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.20|0.12|
71895753|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.18|0.10|
71895754|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.22|0.13|
71895755|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
71895756|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.25|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.25|
71895757|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.08|0.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.14|0.08|
71895758|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.1|||||TWO_SIDED|95.0|0.06|0.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.10|0.06|
71895759|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.46|0.22|
71895760|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.40|
71895761|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.29|
71895762|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.59|0.29|
71895763|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.17|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.38|0.17|
71895764|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.21|0.36|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.36|0.21|
71895765|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.27|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.56|0.27|
71895766|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.13|0.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.28|0.13|
71895767|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.39|0.20|
71676735|NCT04223635|142871364|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|147.17|||||TWO_SIDED|90.0|95.39|227.07|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||227.07|95.39|
71676736|NCT04223635|142871365|OTHER|Least squares means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% CIs for the ratio (%) of GMS were presented.|Ratio (%) of Geometric Least Square Mean|142.87|||||TWO_SIDED|90.0|91.21|223.79|||||For the comparison, moderate HI represents the numerator and normal HF represents the denominator.|||223.79|91.21|
71676737|NCT01399047|142871382|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.105||||0.21|TWO_SIDED|95.0|-0.033|0.243|||Prescott's test||Mycophenolate was tolerated in 17/19 subjects (89.5%, 95% CI: 66.9% - 98.7%), while placebo was tolerated in 19/19 subjects (100%, 95% CI: 82.4% - 100%). The difference in tolerability rates was 10.5% (95% CI: -3.3% - 24.3%, p=0.21).|The primary outcome variable was tolerability, defined as the proportion of subjects able to complete 8 weeks on the assigned treatment. Tolerability was compared among the treatment groups using Prescott's test. A 95% confidence interval was computed for the tolerability of mycophenolate, placebo, and their difference.||0.243|-0.033|0.21
71676738|NCT01399047|142871383|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.72|TWO_SIDED|95.0|-4.67|3.28|||Prescott's test|||||3.28|-4.67|0.72
71676739|NCT01399047|142871384|SUPERIORITY|||||||0.78|||||||Prescott's test|||||||0.78
71676740|NCT01399047|142871385|SUPERIORITY|||||||0.98|||||||Prescott's test|||||||0.98
71676741|NCT01399047|142871386|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71676742|NCT02046005|142871387|SUPERIORITY||Risk Ratio (RR)|1.23||||0.043|TWO_SIDED|95.0|1.01|1.51||We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).|generalized estimating equations||PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)|"In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)"||1.51|1.01|0.043
71844513|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|5.77|||TWO_SIDED|95.0|-9.5|13.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52||13.2|-9.5|
71676743|NCT00251303|142871388|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||Chi-squared|||||||0.959
71676744|NCT00504725|142871390|SUPERIORITY_OR_OTHER|||||||0.39||95.0||||We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.|ANOVA|||IL-6||||0.39
71676745|NCT00504725|142871390|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||IL-8||||0.18
71676746|NCT00504725|142871390|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANOVA|||IL-10||||0.14
71676747|NCT00504725|142871391|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||ANOVA|||||||0.37
71676748|NCT00504725|142871392|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||Baseline Pain Level Score|Fisher Exact|||||||0.44
71676749|NCT00504725|142871392|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||4 Hour Pain Level Score|Fisher Exact|||||||0.20
71676750|NCT00504725|142871392|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||24 Hour Pain Level Score|Fisher Exact|||||||0.37
71676751|NCT00504725|142871392|SUPERIORITY_OR_OTHER|||||||0.15||95.0||||Pain Level Score at Discharge|Fisher Exact|||||||0.15
71676752|NCT03214380|142871419|NON_INFERIORITY|Non-inferiority Margin = 0.4 for HbA1c|Least Square Mean Difference (LSMean)|0.06|||||TWO_SIDED|95.0|-0.05|0.16||||||||0.16|-0.05|
71676753|NCT03214380|142871420|SUPERIORITY||Mean Difference (Net)|-11.8|||<|0.001|TWO_SIDED|95.0|-18.1|-5.5|||ANCOVA|||||-5.5|-18.1|<0.001
71844514|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-10.6|13.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||13.1|-10.6|
71844515|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-10.6|12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56||12.4|-10.6|
71676754|NCT03214380|142871421|SUPERIORITY||Mean Difference (Net)|-17.4|||<|0.001|TWO_SIDED|95.0|-25.3|-9.5|||ANCOVA|||||-9.5|-25.3|<0.001
71676755|NCT02028767|142871467|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.57|STANDARD_ERROR_OF_MEAN|1.024||0|TWO_SIDED|90.0|94.662|102.639||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.639|94.662|0.0000
71676756|NCT02028767|142871467|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.71|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|90.0|94.783|102.796||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.796|94.783|<0.0001
71676757|NCT02028767|142871468|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.93|STANDARD_ERROR_OF_MEAN|1.019||0|TWO_SIDED|90.0|95.856|102.107||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.107|95.856|0.0000
71676758|NCT02028767|142871468|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.96|STANDARD_ERROR_OF_MEAN|1.019|<|0.0001|TWO_SIDED|90.0|95.877|102.15||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.150|95.877|<0.0001
71676759|NCT02028767|142871469|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.28|STANDARD_ERROR_OF_MEAN|1.023||0|TWO_SIDED|90.0|94.549|102.156||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"|||102.156|94.549|0.0000
71676760|NCT02028767|142871469|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.35|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|90.0|94.603|102.252|||ANOVA|The p-value relates to the null hypothesis of non-equivalence.|"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms||102.252|94.603|<0.0001
71676761|NCT03436693|142871477|OTHER|Point Estimate|Difference(Multiple imputation method)|11.3|||||TWO_SIDED|95.0|1.2|21.5||||||||21.5|1.2|
71676762|NCT03436693|142871478|OTHER|Point Estimate|Difference(Multiple imputation method)|3.8|||||TWO_SIDED|95.0|-4.1|11.7||||||||11.7|-4.1|
71844516|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-10.4|13.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||13.5|-10.4|
71844517|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-11.9|11.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60||11.2|-11.9|
71844518|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-9.7|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||14.6|-9.7|
71844519|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-11.7|11.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64||11.3|-11.7|
71844520|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-12.2|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||11.7|-12.2|
71844521|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-9.3|13.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68||13.9|-9.3|
71844522|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.08|||TWO_SIDED|95.0|-9.8|14.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||14.0|-9.8|
71844523|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-14.5|8.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||8.7|-14.5|
71844524|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|6.06|||TWO_SIDED|95.0|-13.7|10.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||10.1|-13.7|
71844525|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-10.0|13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76||13.7|-10.0|
71676763|NCT03436693|142871479|SUPERIORITY||Difference of LSMean|1.09||||0.351|TWO_SIDED|95.0|-1.21|3.4|||Mixed Models Analysis|||||3.40|-1.21|0.351
71676764|NCT03436693|142871480|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.293|TWO_SIDED|95.0|0.23|1.55|||Regression, Cox|||||1.55|0.23|0.293
71676765|NCT03436693|142871481|SUPERIORITY||Ratio of Geometric LSMean|0.52|||<|0.001|TWO_SIDED|95.0|0.418|0.646|||Mixed Models Analysis|||||0.646|0.418|<0.001
71676766|NCT04967885|142871505|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71676767|NCT00626821|142871571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.813|STANDARD_ERROR_OF_MEAN|0.133|<|0.0001|TWO_SIDED|95.0|1.553|2.073|||Mixed Models Analysis|||||2.073|1.553|<0.0001
71676768|NCT02632409|142871572|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0008|TWO_SIDED|98.22|0.55|0.9|||Stratified Cox Proportional hazard model|||||0.90|0.55|0.0008
71676769|NCT02632409|142871573|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.0005|TWO_SIDED|98.72|0.35|0.84|||Stratified Cox Proportional hazard model|||||0.84|0.35|0.0005
71895768|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.28|0.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.67|0.28|
71895769|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.48|
71895770|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.49|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.49|
71895771|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.65|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.65|0.42|
71895772|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.2|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.32|0.20|
71895773|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.43|0.28|
71844526|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|6.13|||TWO_SIDED|95.0|-12.2|11.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||11.8|-12.2|
71844527|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|-9.1|14.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80||14.7|-9.1|
71844528|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|6.01|||TWO_SIDED|95.0|-11.3|12.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||12.3|-11.3|
71844529|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|5.95|||TWO_SIDED|95.0|-11.9|11.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84||11.5|-11.9|
71844530|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|6.04|||TWO_SIDED|95.0|-12.0|11.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||11.7|-12.0|
71844531|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|5.86|||TWO_SIDED|95.0|-13.2|9.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88||9.8|-13.2|
71844532|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-12.6|11.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||11.0|-12.6|
71844533|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|5.87|||TWO_SIDED|95.0|-9.8|13.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92||13.3|-9.8|
71844534|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|6.09|||TWO_SIDED|95.0|-11.1|12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||12.8|-11.1|
71844535|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.91|||TWO_SIDED|95.0|-15.6|7.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||7.6|-15.6|
71676770|NCT01471340|142871580|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The projected sample size provided 90% power at a 2.5% alpha level (one-sided) to determine non-inferiority of MF/F and MF. For analysis of the first SAO in participants, MF/F MDI BID was considered non-inferior to MF MDI BID if the upper bound for the 95% confidence interval (CI) of the hazard ratio (HR) of MF/F MDI BID versus MF MDI BID was lower than 2.0 (noninferiority margin).|Hazard Ratio (HR)|1.22||||0.411|TWO_SIDED|95.0|0.76|1.94|||Cox proportional-hazard model||The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAO; pooled MF/F treatments and pooled MF treatments||1.94|0.76|0.411
71676771|NCT01471340|142871581|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.89||||0.021|TWO_SIDED|95.0|0.8|0.98|||Cox proportional-hazard model|Superiority of MF/F MDI BID vs MF MDI BID was determined if the HR was less than 1 and achieved statistical significance (one-sided p-value \< 0.025).|The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAEX; pooled MF/F treatments and pooled MF treatments||0.98|0.80|0.021
71676772|NCT00526669|142871586|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: TS|Wilcoxon signed rank test|||||||0.10
71676773|NCT00526669|142871586|SUPERIORITY_OR_OTHER|||||||0.097||95.0||||Biomarker: DPD|Wilcoxon signed rank test|||||||0.097
71844536|NCT02307682|143202451|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-15.8|8.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFTns categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||8.0|-15.8|
71844537|NCT02307682|143202452|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.4|-3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-3.3|-16.4|
71844538|NCT02307682|143202452|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-21.3|-7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-7.3|-21.3|
71844539|NCT02307682|143202452|OTHER||Difference in proportions|-8.4|||||TWO_SIDED|95.0|-14.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-14.6|
71844540|NCT02307682|143202452|OTHER||Difference in proportions|-15.0|||||TWO_SIDED|95.0|-20.9|-9.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-9.5|-20.9|
71844541|NCT02307682|143202452|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.8|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.4|-13.8|
71844542|NCT02307682|143202452|OTHER||Difference in proportions|-14.0|||||TWO_SIDED|95.0|-18.9|-8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-8.7|-18.9|
71844543|NCT02307682|143202452|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-16.8|-3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-3.7|-16.8|
71844544|NCT02307682|143202452|OTHER||Difference in proportions|-19.7|||||TWO_SIDED|95.0|-25.8|-13.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-13.4|-25.8|
71844545|NCT02307682|143202452|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.9|-2.0|
71844546|NCT02307682|143202452|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-4.3|7.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.9|-4.3|
71844547|NCT02307682|143202452|OTHER||Difference in proportions|-12.7|||||TWO_SIDED|95.0|-19.1|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-6.0|-19.1|
71895774|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.29|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.29|
71676774|NCT00526669|142871586|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||Biomarker: EGFR/HER1|Wilcoxon signed rank test|||||||0.10
71895775|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.41|0.30|
71895776|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.35|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.45|0.35|
71895777|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.36|
71895778|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.35|0.58|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.58|0.35|
71895779|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.39|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.62|0.39|
71895780|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.54|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.54|0.34|
71895781|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.23|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.42|0.23|
71895782|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.2|||||TWO_SIDED|95.0|0.15|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.24|0.15|
71895783|NCT01025336|143313924|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.42|
71895784|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.50|0.36|
71895785|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.36|0.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.48|0.36|
71895786|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.33|0.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.44|0.33|
71895787|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.26|0.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.37|0.26|
71895788|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.42|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.42|
71895789|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.64|1.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.14|0.64|
71895790|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.6|0.82|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.82|0.60|
71676775|NCT00526669|142871586|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||Biomarker: HER2|Wilcoxon signed rank test|||||||0.26
71676776|NCT00526669|142871586|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||Biomarker: HER3|Wilcoxon signed rank test|||||||0.38
71676777|NCT00526669|142871587|SUPERIORITY_OR_OTHER||percentage of participants|17.9|||||TWO_SIDED|95.0|9.6|29.2|||||The estimated value represents the percentage of participants with complete response or partial response.|||29.2|9.6|
71676778|NCT00526669|142871588|SUPERIORITY_OR_OTHER||percentage of participants|29.0|||||TWO_SIDED|95.0|17.9|40.3|||||The estimated value reflects the percentage of participants who achieved progression-free survival.|||40.3|17.9|
71676779|NCT04259424|142871612|OTHER|||||||0.15|||||||t-test, 2 sided|||||||.15
71676780|NCT01082211|142871660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||Chi-squared|||Assuming a 3-year rate of 25% using a chi-squared test, a sample size of 55 patients will ensure at least 90% probability of detecting a reduction in the 3-year ipsilateral in-breast recurrence rate from 25% to 9%, with a significance level of 0.05 (1-sided). In-breast recurrence will be estimated using the cumulative incidence method.||||0.0002
71676781|NCT01082211|142871668|OTHER||Effect size|0.1|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
71676782|NCT01082211|142871668|OTHER||Effect size|0.14|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
71676783|NCT01082211|142871668|OTHER||Effect size|0.34|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
71811792|NCT03494166|143126255|SUPERIORITY|The key parameter was the coefficient for the trial arm from the second randomization variable in linear regression model.|Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|2.91||0.79|TWO_SIDED|95.0|-6.53|5.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Regression, Linear|The model included the adjustment for baseline value of the outcome.|The mean of the group that continued with SMSH alone minus the mean of the group that had TIPC added to the SMSH after week 4.|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Sample size was determined by the power calculation for the primary outcome.||5.01|-6.53|.79
71811793|NCT02110901|143126262|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.254|TWO_SIDED|95.0|0.61|1.14|||Log Rank|||||1.14|0.61|0.254
71811794|NCT02110901|143126263|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.048|TWO_SIDED|95.0|0.43|1.0|||Log Rank|||||1.00|0.43|0.048
71811795|NCT02110901|143126264|SUPERIORITY|||||||0.109|||||||Chi-squared|||||||0.109
71676784|NCT01082211|142871669|OTHER||Effect size|0.04|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Functional status||||
71811796|NCT02110901|143126265|SUPERIORITY|||||||0.035|||||||Chi-squared|||||||0.035
71895791|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.86|1.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.18|0.86|
71676785|NCT01082211|142871669|OTHER||Effect size|0.32|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Cosmetic||||
71676786|NCT01082211|142871669|OTHER||Effect size|0.28|||||TWO_SIDED||||||||Effect sizes are interpreted as negligible: \< 0.3; small: 0.3 to \< 0.5; moderate: 0.5 to \< 0.7; and large ≥ 0.7|Breast-specific pain||||
71676787|NCT01082211|142871671|OTHER|||||||0.054|||||||Spearman rank-order correlation test|||||||0.054
71676788|NCT01082211|142871671|OTHER|||||||0.044|||||||Spearman rank-order correlation test|||||||0.044
71676789|NCT01082211|142871671|OTHER|||||||0.087|||||||Spearman rank-order correlation test|||||||0.087
71676790|NCT00910208|142871712|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
71676791|NCT00910208|142871713|SUPERIORITY|||||||0.47|||||||Chi-squared|||||||0.47
71676792|NCT00910208|142871714|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.06
71676793|NCT00910208|142871715|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
71676794|NCT00910208|142871716|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71676795|NCT00910208|142871717|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71676796|NCT04016779|142871718|SUPERIORITY||Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.28||0.004|TWO_SIDED|95.0|-6.2|-1.2|||Mixed Model for Repeated Measures|||||-1.2|-6.2|0.0040
71676797|NCT04016779|142871719|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.2|||Mixed Model for Repeated Measures|||||-0.2|-0.7|0.0023
71676798|NCT04016779|142871720|SUPERIORITY||Difference in percentage of responders|5.6||||0.303|TWO_SIDED|95.0|-5.0|16.1|||Pearson's chi-squared test|||||16.1|-5.0|0.3030
71676799|NCT04016779|142871721|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0076|TWO_SIDED|95.0|-0.6|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-0.6|0.0076
71676800|NCT04016779|142871722|SUPERIORITY||Difference in percentage of responders|10.7||||0.0744|TWO_SIDED|95.0|-1.0|22.1|||Pearson's chi-squared test|||||22.1|-1.0|0.0744
71676801|NCT04016779|142871723|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.43||0.9205|TWO_SIDED|95.0|-0.9|0.8|||Mixed Model for Repeated Measures|||||0.8|-0.9|0.9205
71676802|NCT04016779|142871724|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.77||0.0015|TWO_SIDED|95.0|-4.0|-0.9|||Mixed Model for Repeated Measures|||||-0.9|-4.0|0.0015
71676803|NCT04016779|142871725|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.038|TWO_SIDED|95.0|-2.7|-0.1|||Mixed Model for Repeated Measures|||||-0.1|-2.7|0.0380
71676804|NCT04016779|142871726|SUPERIORITY||Difference in percentage of responders|12.4||||0.0395|TWO_SIDED|95.0|0.6|23.8|||Pearson's chi-squared test|||||23.8|0.6|0.0395
71811797|NCT00855595|143126306|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0903|||||||ANCOVA|||||||0.0903
71811798|NCT02532556|143126327|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
71811799|NCT02532556|143126328|SUPERIORITY||||||<|0.05|||||||Wilcoxan signed-rank test|||||||<0.05
71811800|NCT00696410|143126330|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||p value represents test of paired (within patient) difference||||0.068
71811801|NCT00696410|143126330|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.022
71811802|NCT00696410|143126331|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED|95.0|||||Sign test|||p value represents test of paired (within patient) difference||||0.71
71811803|NCT00696410|143126331|SUPERIORITY_OR_OTHER|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.33
71811804|NCT00696410|143126332|SUPERIORITY_OR_OTHER|||||||0.69|||||||Sign test|||p value represents test of paired (within patient) difference||||0.69
71811805|NCT00696410|143126332|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.004
71811806|NCT00696410|143126333|SUPERIORITY_OR_OTHER|||||||0.48|||||||Sign test|||p value represents test of paired (within patient) difference||||0.48
71811807|NCT00696410|143126333|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.39
71811808|NCT00696410|143126334|SUPERIORITY_OR_OTHER|||||||0.92|||||||Sign test|||p value represents test of paired (within patient) difference||||0.92
71811809|NCT00696410|143126334|SUPERIORITY_OR_OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)||||0.22
71811810|NCT01951638|143126338|OTHER||Log-Scale mean difference|0.137|||=|0.8991|TWO_SIDED|90.0|-0.04|0.31|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups BAY1021189 (2.5mg, 2.5 to 5mg, 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means. The difference between the comparison groups is difference of means on the log scale.||0.31|-0.04|= 0.8991
71811811|NCT01951638|143126338|OTHER||Log-Scale mean difference|0.076|||=|0.7194|TWO_SIDED|95.0|-0.18|0.33|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.33|-0.18|= 0.7194
71811812|NCT01951638|143126338|OTHER||Log-Scale mean difference|0.156|||=|0.8653|TWO_SIDED|95.0|-0.12|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.12|= 0.8653
71811813|NCT01951638|143126338|OTHER||Log-Scale mean difference|0.171|||=|0.9041|TWO_SIDED|95.0|-0.09|0.43|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.43|-0.09|= 0.9041
71811814|NCT01951638|143126338|OTHER||Log-Scale mean difference|0.052|||=|0.6572|TWO_SIDED|95.0|-0.2|0.3|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||0.3|-0.2|= 0.6572
71811815|NCT01951638|143126339|OTHER||Mean Difference (Net)|1.629|||=|0.8156|TWO_SIDED|90.0|-1.36|4.62|||t-test, 1 sided|||For the primary analysis, the three highest active treatment groups (BAY1021189 2.5mg, BAY1021189 2.5 to 5mg, BAY1021189 2.5 to 10mg) were pooled and compared to the assigned placebo treatment group with a one-sided two-sample t-test. The Hochberg procedure was used to test the two primary end points at study-wise significance level of 5%. Results are reported including 90% confidence intervals (CI) for the difference of means.||4.62|-1.36|= 0.8156
71811816|NCT01951638|143126339|OTHER||Mean Difference (Net)|1.707|||=|0.7945|TWO_SIDED|95.0|-2.39|5.8|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.8|-2.39|= 0.7945
71811817|NCT01951638|143126339|OTHER||Mean Difference (Net)|2.109|||=|0.7917|TWO_SIDED|95.0|-3.01|7.23|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||7.23|-3.01|= 0.7917
71811818|NCT01951638|143126339|OTHER||Mean Difference (Net)|1.219|||=|0.7241|TWO_SIDED|95.0|-2.82|5.26|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||5.26|-2.82|= 0.7241
71676805|NCT04016779|142871727|SUPERIORITY||Difference in percentage of responders|6.4||||0.2736|TWO_SIDED|95.0|-5.0|17.5|||Pearson's chi-squared test|||||17.5|-5.0|0.2736
71811819|NCT01951638|143126339|OTHER||Mean Difference (Net)|1.198|||=|0.7546|TWO_SIDED|95.0|-2.23|4.63|||t-test, 1 sided|||Pairwise comparisons to placebo were performed in a hierarchical manner (from BAY1021189 from 2.5 to 10mg dose arm to BAY1021189 1.25mg dose arm). In accordance with the specification in the protocol these secondary analyses are considered exploratory only, since the primary analyses were not significant.||4.63|-2.23|= 0.7546
71811820|NCT01345630|143126376|NON_INFERIORITY_OR_EQUIVALENCE|For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.|Mean Difference (Final Values)|-9.54|||||TWO_SIDED|95.0|-14.83|-4.24||||||The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (\>=100,000 copies/mL or \<100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.||-4.24|-14.83|
71811821|NCT01345630|143126384|SUPERIORITY_OR_OTHER||Treatment difference|-0.075|STANDARD_ERROR_OF_MEAN|0.0303|||TWO_SIDED|95.0|-0.1343|-0.0157||||||The difference in proportions of patients with plasma HIV-1 RNA \<50 copies/mL at Week 48 between the \[MVC+DRV/r\] and the \[FTC/TDF+DRV/r\] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.||-0.0157|-0.1343|
71811822|NCT01345630|143126389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.975|TWO_SIDED|95.0|-24.4|23.6|||ANCOVA|||Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||23.6|-24.4|0.9750
71811823|NCT01345630|143126390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.1|-1.5|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-1.5|-3.1|<0.0001
71811824|NCT01345630|143126391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|127.7|||<|0.0001|TWO_SIDED|95.0|76.5|178.8|||ANCOVA|||Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||178.8|76.5|<0.0001
71811825|NCT01345630|143126392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.1|3.1|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||3.1|1.1|<0.0001
71811826|NCT01345630|143126393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.07|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.||-0.07|-0.15|<0.0001
71811827|NCT01345630|143126394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.861||||0.8379|TWO_SIDED|95.0|-658.181|809.903|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||809.903|-658.181|0.8379
71811828|NCT01345630|143126395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031||||0.3376|TWO_SIDED|95.0|-0.033|0.094|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.094|-0.033|0.3376
71811829|NCT01345630|143126396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014||||0.0043|TWO_SIDED|95.0|0.004|0.023|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.023|0.004|0.0043
71676806|NCT04016779|142871728|SUPERIORITY||Least Square Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.22||0.0468|TWO_SIDED|95.0|-4.8|0.0|||ANCOVA|||||0.0|-4.8|0.0468
71811830|NCT01345630|143126397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008||||0.2273|TWO_SIDED|95.0|-0.005|0.022|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.022|-0.005|0.2273
71811831|NCT01345630|143126398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.4188|TWO_SIDED|95.0|-0.007|0.018|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.018|-0.007|0.4188
71811832|NCT01345630|143126399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.1722|TWO_SIDED|95.0|-5.17|0.94|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||0.94|-5.17|0.1722
71811833|NCT01345630|143126400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-126.78||||0.0071|TWO_SIDED|95.0|-218.34|-35.23|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.||-35.23|-218.34|0.0071
71811834|NCT03938454|143126408|OTHER||Hodges-Lehmann|45.98||||0.0676|TWO_SIDED|95.0|23.5|65.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% percent reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||65.36|23.50|0.0676
71676807|NCT04016779|142871729|SUPERIORITY||Least Square Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.04||0.4462|TWO_SIDED|95.0|-2.8|1.3|||ANCOVA|||||1.3|-2.8|0.4462
71676808|NCT04016779|142871730|SUPERIORITY||Least Square Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|1.29||0.01|TWO_SIDED|95.0|-5.9|-0.8|||ANCOVA|||||-0.8|-5.9|0.0100
71811835|NCT03938454|143126414|OTHER||Hodges-Lehmann|50.2||||0.0259|TWO_SIDED|95.0|27.94|67.36||P-value is from one-sided Wilcoxon Sign Rank Test with at least 25% reduction from Baseline (adjusted for 26 weeks) as outcome variable.|Wilcoxon Sign Rank Test|||||67.36|27.94|0.0259
71811836|NCT01787097|143126436|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71811837|NCT00949884|143126441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.63|<|0.0001|TWO_SIDED|95.0|-3.8|-1.3|||ANCOVA|The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.||Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.||-1.3|-3.8|<0.0001
71811838|NCT00949884|143126442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.88|<|0.0001|TWO_SIDED|95.0|-5.3|-1.8|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.8|-5.3|<0.0001
71811839|NCT00949884|143126443|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.99||0.0001|TWO_SIDED|95.0|-5.8|-1.9|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.||||-1.9|-5.8|0.0001
71811840|NCT00949884|143126444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.58|<|0.0001|TWO_SIDED|95.0|-3.8|-1.5|||ANCOVA|ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.||||-1.5|-3.8|<0.0001
71811841|NCT00949884|143126446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.55||0.1121|TWO_SIDED|95.0|-2.0|0.2|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.2|-2.0|0.1121
71811842|NCT00949884|143126446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.54||0.0783|TWO_SIDED|95.0|-2.0|0.1|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.1|-2.0|0.0783
71811843|NCT00949884|143126447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.2312|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.7|-2.9|0.2312
71811844|NCT00949884|143126447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.0979|TWO_SIDED|95.0|-3.2|0.3|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.||||0.3|-3.2|0.0979
71811845|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
71811846|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||0.0001
71811847|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
71811848|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||<0.0001
71811849|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
71811850|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||<0.0001
71811851|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.2755||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.2755
71811852|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.1646||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.1646
71811853|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
71811854|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||<0.0001
71811855|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.|Regression, Logistic|||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
71895792|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.3|||||TWO_SIDED|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.33|0.22|
71895793|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.81|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.46|0.81|
71895794|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.34|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.51|0.34|
71676809|NCT04016779|142871731|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.16||0.2186|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|||||0.9|-3.7|0.2186
71811856|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||<0.0001
71676810|NCT04016779|142871732|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.1||0.0344|TWO_SIDED|95.0|-4.5|-0.2|||ANCOVA|||||-0.2|-4.5|0.0344
71811857|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0010
71811858|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0011
71811859|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
71844548|NCT02307682|143202452|OTHER||Difference in proportions|-23.4|||||TWO_SIDED|95.0|-29.7|-17.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-17.6|-29.7|
71844549|NCT02307682|143202452|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.4|-8.7|
71895795|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.66|1.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.09|0.66|
71895796|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.37|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.68|0.37|
71811860|NCT00949884|143126448|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
71895797|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.43|0.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.77|0.43|
71676811|NCT04016779|142871733|SUPERIORITY||Least Square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.99||0.368|TWO_SIDED|95.0|-1.1|2.8|||ANCOVA|||||2.8|-1.1|0.3680
71676812|NCT04016779|142871734|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6361|TWO_SIDED|95.0|-2.7|1.6|||ANCOVA|||||1.6|-2.7|0.6361
71811861|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0005
71844550|NCT02307682|143202452|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-11.2|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.4|-11.2|
71844551|NCT02307682|143202452|OTHER||Difference in proportions|-7.7|||||TWO_SIDED|95.0|-14.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-1.0|-14.3|
71676813|NCT04016779|142871735|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.2||0.1708|TWO_SIDED|95.0|-4.0|0.7|||ANCOVA|||||0.7|-4.0|0.1708
71811862|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0004
71811863|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.0023||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0023
71811864|NCT00949884|143126448|SUPERIORITY_OR_OTHER|||||||0.0012||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0012
71811865|NCT00949884|143126449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
71676814|NCT04016779|142871736|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.3||0.0094|TWO_SIDED|95.0|-6.0|-0.8|||ANCOVA|||||-0.8|-6.0|0.0094
71676815|NCT04016779|142871737|SUPERIORITY||Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.34||0.0104|TWO_SIDED|95.0|-6.1|-0.8|||ANCOVA|||||-0.8|-6.1|0.0104
71676816|NCT04016779|142871738|SUPERIORITY||Least Square Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.13||0.0178|TWO_SIDED|95.0|-4.9|-0.5|||ANCOVA|||||-0.5|-4.9|0.0178
71811866|NCT00949884|143126449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<140 mmHg||||<0.0001
71811867|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0009
71811868|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<135 mmHg||||0.0007
71811869|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0347||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0347
71811870|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<130 mmHg||||0.0280
71811871|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0519||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0519
71811872|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0605||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of \<120 mmHg||||0.0605
71811873|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0001
71811874|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<90 mmHg||||0.0003
71811875|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0070
71811876|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0066||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<85 mmHg||||0.0066
71811877|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0061||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0061
71811878|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of \<80 mmHg||||0.0096
71811879|NCT00949884|143126449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
71811880|NCT00949884|143126449|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<140/90 mmHg||||<0.0001
71844552|NCT02307682|143202452|OTHER||Difference in proportions|-12.4|||||TWO_SIDED|95.0|-19.3|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-6.2|-19.3|
71844553|NCT02307682|143202452|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.2|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.2|-13.2|
71844554|NCT02307682|143202452|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-15.9|-4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-4.9|-15.9|
71844555|NCT02307682|143202452|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.5|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||0.9|-11.5|
71895798|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.4|||||TWO_SIDED|95.0|0.3|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.60|0.30|
71811881|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0047
71811882|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<135/80 mmHg||||0.0063
71811883|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0589
71811884|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0594||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<130/80 mmHg||||0.0594
71895799|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.47|0.98|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.98|0.47|
71844556|NCT02307682|143202452|OTHER||Difference in proportions|-11.4|||||TWO_SIDED|95.0|-17.7|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.6|-17.7|
71844557|NCT02307682|143202452|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.1|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.7|-5.1|
71844558|NCT02307682|143202452|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.7|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||2.4|-8.7|
71844559|NCT02307682|143202452|OTHER||Difference in proportions|-11.6|||||TWO_SIDED|95.0|-17.8|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-5.5|-17.8|
71844560|NCT02307682|143202452|OTHER||Difference in proportions|-15.6|||||TWO_SIDED|95.0|-21.2|-9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-9.7|-21.2|
71844561|NCT02307682|143202452|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-8.0|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.0|-8.0|
71844562|NCT02307682|143202452|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-13.7|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||-3.4|-13.7|
71844563|NCT02307682|143202452|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.6|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.7|-12.6|
71844564|NCT02307682|143202452|OTHER||Difference in proportions|-9.6|||||TWO_SIDED|95.0|-16.0|-3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-3.8|-16.0|
71844565|NCT02307682|143202452|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.9|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||0.7|-9.9|
71844566|NCT02307682|143202452|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.9|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-3.4|-13.9|
71844567|NCT02307682|143202452|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-13.1|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.2|-13.1|
71844568|NCT02307682|143202452|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-17.8|-6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-6.0|-17.8|
71844569|NCT02307682|143202452|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.5|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-2.5|
71844570|NCT02307682|143202452|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-6.7|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.7|-6.7|
71895800|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.72|1.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.01|0.72|
71811885|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0476||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0476
71811886|NCT00949884|143126449|SUPERIORITY_OR_OTHER|||||||0.0657||95.0|||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of \<120/80 mmHg||||0.0657
71811887|NCT00949884|143126450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.325|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3250
71811888|NCT00949884|143126450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.3491|TWO_SIDED|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.||1.5|-4.4|0.3491
71811889|NCT00949884|143126450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.2085|TWO_SIDED|95.0|-3.2|0.7|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.7|-3.2|0.2085
71844571|NCT02307682|143202452|OTHER||Difference in proportions|-7.5|||||TWO_SIDED|95.0|-12.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.6|-12.8|
71844572|NCT02307682|143202452|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-18.2|-7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-7.0|-18.2|
71844573|NCT02307682|143202452|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.5|-7.0|
71811890|NCT00949884|143126450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.2542|TWO_SIDED|95.0|-3.0|0.8|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.||0.8|-3.0|0.2542
71811891|NCT00949884|143126451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0209|TWO_SIDED|95.0|-6.6|-0.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.5|-6.6|0.0209
71811892|NCT00949884|143126451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.0186|TWO_SIDED|95.0|-6.6|-0.6|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.||-0.6|-6.6|0.0186
71811893|NCT00949884|143126451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0175|TWO_SIDED|95.0|-4.5|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.5|0.0175
71811894|NCT00949884|143126451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0177|TWO_SIDED|95.0|-4.4|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.||-0.4|-4.4|0.0177
71811895|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3104|TWO_SIDED|95.0|-5.2|1.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.7|-5.2|0.3104
71811896|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3653|TWO_SIDED|95.0|-4.9|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||1.8|-4.9|0.3653
71811897|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.1197|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.5|-4.1|0.1197
71811898|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1654|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||0.7|-3.9|0.1654
71811899|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.4362|TWO_SIDED|95.0|-4.4|1.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.9|-4.4|0.4362
71811900|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.4039|TWO_SIDED|95.0|-4.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||1.8|-4.5|0.4039
71811901|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.3929|TWO_SIDED|95.0|-3.1|1.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.2|-3.1|0.3929
71811902|NCT00949884|143126452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4259|TWO_SIDED|95.0|-3.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||1.3|-3.0|0.4259
71811903|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0396|TWO_SIDED|95.0|-6.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.2|-6.8|0.0396
71811904|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0345|TWO_SIDED|95.0|-6.8|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure||-0.3|-6.8|0.0345
71811905|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0324|TWO_SIDED|95.0|-4.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.8|0.0324
71811906|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.0363|TWO_SIDED|95.0|-4.7|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure||-0.2|-4.7|0.0363
71811907|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0988|TWO_SIDED|95.0|-6.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.6|-6.5|0.0988
71811908|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0926|TWO_SIDED|95.0|-6.4|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure||0.5|-6.4|0.0926
71811909|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.09|TWO_SIDED|95.0|-4.5|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.5|0.0900
71811910|NCT00949884|143126453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.0942|TWO_SIDED|95.0|-4.4|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure||0.3|-4.4|0.0942
71811911|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.3229|TWO_SIDED|95.0|-5.4|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-5.4|0.3229
71811912|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.3863|TWO_SIDED|95.0|-5.1|2.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||2.0|-5.1|0.3863
71811913|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1277|TWO_SIDED|95.0|-4.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.6|-4.5|0.1277
71811914|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.1799|TWO_SIDED|95.0|-4.3|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.8|-4.3|0.1799
71811915|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2708|TWO_SIDED|95.0|-5.1|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.4|-5.1|0.2708
71811916|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.3133|TWO_SIDED|95.0|-5.0|1.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||1.6|-5.0|0.3133
71811917|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.1621|TWO_SIDED|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.7|-3.9|0.1621
71811918|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2314|TWO_SIDED|95.0|-3.7|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.9|-3.7|0.2314
71811919|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.2461|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2461
71811920|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.2558|TWO_SIDED|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||1.3|-5.0|0.2558
71811921|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.17|TWO_SIDED|95.0|-3.8|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.7|-3.8|0.1700
71811922|NCT00949884|143126454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2011|TWO_SIDED|95.0|-3.7|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||0.8|-3.7|0.2011
71811923|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.1895|TWO_SIDED|95.0|-7.0|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.4|-7.0|0.1895
71811924|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.2701|TWO_SIDED|95.0|-6.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure||1.8|-6.5|0.2701
71811925|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.1328|TWO_SIDED|95.0|-5.2|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.7|-5.2|0.1328
71811926|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1778|TWO_SIDED|95.0|-4.9|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure||0.9|-4.9|0.1778
71811927|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.062|TWO_SIDED|95.0|-7.3|0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.2|-7.3|0.0620
71811928|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.1011|TWO_SIDED|95.0|-6.9|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure||0.6|-6.9|0.1011
71811929|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.0249|TWO_SIDED|95.0|-5.6|-0.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||-0.4|-5.6|0.0249
71811930|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.0497|TWO_SIDED|95.0|-5.2|0.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure||0.0|-5.2|0.0497
71811931|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0552|TWO_SIDED|95.0|-7.1|0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.1|-7.1|0.0552
71811932|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.0767|TWO_SIDED|95.0|-6.8|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure||0.3|-6.8|0.0767
71895801|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.71|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.00|0.71|
71895802|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.5|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.66|0.50|
71811933|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0279|TWO_SIDED|95.0|-5.3|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.3|-5.3|0.0279
71811934|NCT00949884|143126455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.0434|TWO_SIDED|95.0|-5.0|-0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure||-0.1|-5.0|0.0434
71811935|NCT00949884|143126456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Diastolic blood pressure||-1.8|-6.8|0.0009
71811936|NCT00949884|143126456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.6|||<|0.0001|TWO_SIDED|95.0|-12.5|-4.7|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Systolic blood pressure||-4.7|-12.5|<0.0001
71811937|NCT03810534|143126457|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|3.24||0.62|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.62
71811938|NCT03810534|143126458|SUPERIORITY||Mean Difference (Final Values)|-1.47|STANDARD_ERROR_OF_MEAN|1.44||0.31|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.31
71811939|NCT03810534|143126459|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.33||0.93|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.93
71811940|NCT03810534|143126460|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.34||0.6|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.60
71811941|NCT03810534|143126461|SUPERIORITY||Mean Difference (Final Values)|2.24|STANDARD_ERROR_OF_MEAN|3.49||0.53|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.53
71811942|NCT03810534|143126462|SUPERIORITY||Mean Difference (Final Values)|0.78|STANDARD_ERROR_OF_MEAN|3.57||0.83|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.83
71811943|NCT03810534|143126463|SUPERIORITY||Mean Difference (Final Values)|0.67|STANDARD_ERROR_OF_MEAN|2.05||0.75|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.75
71811944|NCT03810534|143126464|SUPERIORITY||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.07||0.5|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.50
71811945|NCT03810534|143126465|SUPERIORITY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.5||0.48|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.48
71811946|NCT03810534|143126466|SUPERIORITY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.52||0.22|TWO_SIDED||||||Mixed Models Analysis||The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.|||||.22
71811947|NCT03810534|143126467|SUPERIORITY||Mean ratio|0.96|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||||||.88
71811948|NCT03810534|143126468|SUPERIORITY||Mean ratio|0.72|STANDARD_ERROR_OF_MEAN|0.18||0.23|TWO_SIDED||||||Mixed Models Analysis|||||||.23
71844574|NCT02307682|143202452|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.7|-11.4|
71844575|NCT02307682|143202452|OTHER||Difference in proportions|-6.1|||||TWO_SIDED|95.0|-11.8|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.1|-11.8|
71844576|NCT02307682|143202452|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.0|-6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-6.4|-17.0|
71844577|NCT02307682|143202452|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.1|-10.1|
71844578|NCT02307682|143202452|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.0|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.0|-10.0|
71844579|NCT02307682|143202452|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.7|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.5|-11.7|
71844580|NCT02307682|143202452|OTHER||Difference in proportions|-11.7|||||TWO_SIDED|95.0|-17.3|-6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-6.3|-17.3|
71844581|NCT02307682|143202452|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.0|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.5|-4.0|
71676817|NCT04016779|142871739|SUPERIORITY||Least Square Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|1.34||0.0187|TWO_SIDED|95.0|-5.8|-0.5|||ANCOVA|||||-0.5|-5.8|0.0187
71844582|NCT02307682|143202452|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-9.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||-0.3|-9.7|
71844583|NCT02307682|143202452|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.1|-11.4|
71844584|NCT02307682|143202452|OTHER||Difference in proportions|-11.1|||||TWO_SIDED|95.0|-16.4|-6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.2|-16.4|
71844585|NCT02307682|143202453|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-7.9|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.9|
71844586|NCT02307682|143202453|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.1|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||7.4|-4.1|
71844587|NCT02307682|143202453|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-10.0|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.3|-10.0|
71811949|NCT00166296|143126471|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.441|TWO_SIDED|95.0|0.075|2.141|||Fisher Exact|||||2.141|0.075|0.441
71676818|NCT02295020|142871740|SUPERIORITY_OR_OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
71676819|NCT02295020|142871741|SUPERIORITY_OR_OTHER|||||||0.232|||||||t-test, 2 sided|||||||0.232
71676820|NCT02295020|142871742|SUPERIORITY_OR_OTHER|||||||0.311|||||||t-test, 2 sided|||||||0.311
71811950|NCT00166296|143126472|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
71811951|NCT00166296|143126473|SUPERIORITY_OR_OTHER_LEGACY|||||||0.443||95.0|||||ANOVA|||||||0.443
71811952|NCT00166296|143126474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||95.0|||||ANOVA|||||||0.930
71676821|NCT02295020|142871744|SUPERIORITY_OR_OTHER|||||||0.449|||||||t-test, 2 sided|||||||0.449
71676822|NCT02295020|142871745|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.860
71811953|NCT04252742|143126502|SUPERIORITY||LSM difference|-7.95|||<|0.001|TWO_SIDED|95.0|-11.45|-4.46||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-4.46|-11.45|< 0.001
71811954|NCT04252742|143126503|SUPERIORITY||LSM difference|-7.36|||<|0.001|TWO_SIDED|95.0|-10.8|-3.92||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-3.92|-10.80|< 0.001
71811955|NCT04252742|143126504|SUPERIORITY||LSM difference|-7.1|||<|0.001|TWO_SIDED|95.0|-10.34|-3.87||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.87|-10.34|< 0.001
71811956|NCT04252742|143126505|SUPERIORITY||LSM difference|-7.05|||<|0.001|TWO_SIDED|95.0|-10.76|-3.34||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.34|-10.76|< 0.001
71811957|NCT04252742|143126506|SUPERIORITY||LSM difference|-6.82|||<|0.001|TWO_SIDED|95.0|-10.37|-3.27||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-3.27|-10.37|< 0.001
71811958|NCT04252742|143126507|SUPERIORITY||LSM difference|-1.07||||0.013|TWO_SIDED|95.0|-1.92|-0.22||Nominal p-value is presented without multiplicity adjustment.|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates.|Erenumab 140 mg SC Q4W - Placebo|||-0.22|-1.92|0.013
71811959|NCT04252742|143126508|SUPERIORITY||LSM difference|-0.48||||0.011|TWO_SIDED|95.0|-0.85|-0.11||Nominal p-value is presented without multiplicity adjustment|Mixed Models Analysis|Treatment, visit, treatment-by-visit interaction, and baseline value as covariates|Erenumab 140 mg SC Q4W - Placebo|||-0.11|-0.85|0.011
71676823|NCT02295020|142871746|SUPERIORITY_OR_OTHER|||||||0.735|||||||Wilcoxon (Mann-Whitney)|||||||0.735
71811960|NCT04270747|143126531|OTHER|A pre-specified similarity margin of (-3, 3) ETDRS letters was used to demonstrate clinical similarity for the mean change from Baseline in BCVA at Week 8.|Difference between means|0.1|||||TWO_SIDED|90.0|-1.1|1.3|||||Estimated using analysis of covariance (ANCOVA) model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||1.3|-1.1|
71811961|NCT04270747|143126532|OTHER||Risk Difference (RD)|-2.1|||||TWO_SIDED|90.0|-5.2|2.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.2|-5.2|
71811962|NCT04270747|143126532|OTHER||Risk Difference (RD)|-1.7|||||TWO_SIDED|90.0|-6.2|2.8|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who maintained vision at Week 52.||2.8|-6.2|
71844588|NCT02307682|143202453|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||4.5|-7.7|
71844589|NCT02307682|143202453|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.6|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.3|-7.6|
71676824|NCT02295020|142871747|SUPERIORITY_OR_OTHER|||||||0.479|||||||Wilcoxon (Mann-Whitney)|||||||0.479
71676825|NCT02295020|142871748|SUPERIORITY_OR_OTHER|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
71676826|NCT02295020|142871749|SUPERIORITY_OR_OTHER|||||||0.878|||||||Wilcoxon (Mann-Whitney)|||||||0.878
71676827|NCT01146379|142871753|SUPERIORITY_OR_OTHER|||||||0.01||||||a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons|Mixed Models Analysis|||The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.||||.01
71676828|NCT01146379|142871753|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||This analysis then asked which groups were different from the Low Movement Dose group||||.036
71676829|NCT01146379|142871753|SUPERIORITY_OR_OTHER|||||||0.679|||||||t-test, 2 sided|||This analysis asked if the Low Movement Dose group was different from the High Movement Dose group||||0.679
71811963|NCT04270747|143126533|OTHER||Difference between means|-0.1|||||TWO_SIDED|90.0|-1.3|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||1.2|-1.3|
71676830|NCT01146379|142871753|SUPERIORITY_OR_OTHER|||||||0.209|||||||t-test, 2 sided|||This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group||||0.209
71844590|NCT02307682|143202453|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||5.8|-5.4|
71844591|NCT02307682|143202453|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.3|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.6|-8.3|
71844592|NCT02307682|143202453|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-10.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.9|-10.0|
71844593|NCT02307682|143202453|OTHER||Difference in proportions|10.6|||||TWO_SIDED|95.0|5.0|16.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||16.2|5.0|
71844594|NCT02307682|143202453|OTHER||Difference in proportions|10.0|||||TWO_SIDED|95.0|4.7|15.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||15.4|4.7|
71844595|NCT02307682|143202453|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.8|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.7|-9.8|
71844596|NCT02307682|143202453|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-14.9|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.0|-14.9|
71844597|NCT02307682|143202453|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-2.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||8.4|-2.1|
71844598|NCT02307682|143202453|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||5.1|-6.3|
71844599|NCT02307682|143202453|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-5.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||6.1|-5.8|
71844600|NCT02307682|143202453|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-8.4|
71844601|NCT02307682|143202453|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.4|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.4|-6.4|
71844602|NCT02307682|143202453|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.8|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.0|-7.8|
71844603|NCT02307682|143202453|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.6|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.7|-9.6|
71844604|NCT02307682|143202453|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-10.2|
71676831|NCT01876784|142871792|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.08|TWO_SIDED|95.0|0.55|1.03||Threshold for significance at 0.05 level.|Log Rank||Vandetanib 300 mg vs Placebo|A multiple testing procedure (MTP) with an alpha-exhaustive recycling strategy was employed to provide adequate control of type I error.||1.03|0.55|0.080
71811964|NCT04270747|143126533|OTHER||Difference between means|-0.8|||||TWO_SIDED|90.0|-2.3|0.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||0.7|-2.3|
71811965|NCT04270747|143126533|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-1.9|1.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.2|-1.9|
71811966|NCT04270747|143126533|OTHER||Difference between means|0.4|||||TWO_SIDED|90.0|-1.3|2.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.1|-1.3|
71844605|NCT02307682|143202453|OTHER||Difference in proportions|4.6|||||TWO_SIDED|95.0|-1.0|9.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||9.9|-1.0|
71844606|NCT02307682|143202453|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.3|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.5|-3.3|
71676832|NCT03605862|142871799|SUPERIORITY|||||||0.4009|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.4009
71676833|NCT03605862|142871800|SUPERIORITY|||||||0.1923|||||||Gehan-Wilcoxon|Analysis was stratified by time from onset of symptoms, pre-enrollment symptom relief medication use, and presence of underlying lung conditions||||||0.1923
71676834|NCT03605862|142871801|SUPERIORITY|||||||0.2057|||||||Fisher Exact|||||||0.2057
71811967|NCT04270747|143126533|OTHER||Difference between means|-1.3|||||TWO_SIDED|90.0|-3.1|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.5|-3.1|
71844607|NCT02307682|143202453|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-6.2|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.1|-6.2|
71844608|NCT02307682|143202453|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.5|-6.4|
71844609|NCT02307682|143202453|OTHER||Difference in proportions|3.3|||||TWO_SIDED|95.0|-2.2|8.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.7|-2.2|
71844610|NCT02307682|143202453|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-3.2|7.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||7.4|-3.2|
71844611|NCT02307682|143202453|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-3.5|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||8.1|-3.5|
71844612|NCT02307682|143202453|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.8|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.8|-5.8|
71844613|NCT02307682|143202453|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.8|-6.6|
71676835|NCT03605862|142871802|SUPERIORITY|||||||0.0712|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at Baseline, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0712
71676836|NCT03605862|142871803|SUPERIORITY|||||||1|||||||Fisher Exact|||Comparison for study day 2||||1.0000
71811968|NCT04270747|143126533|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-2.3|1.4|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||1.4|-2.3|
71811969|NCT04270747|143126533|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.2|0.8|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||0.8|-3.2|
71811970|NCT04270747|143126533|OTHER||Difference between means|-1.5|||||TWO_SIDED|2.0|-3.4|0.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||0.5|-3.4|
71811971|NCT04270747|143126533|OTHER||Difference between means|-1.5|||||TWO_SIDED|90.0|-3.0|0.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 4.||0.0|-3.0|
71811972|NCT04270747|143126533|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-3.6|-0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 8.||-0.2|-3.6|
71811973|NCT04270747|143126533|OTHER||Difference between means|-0.3|||||TWO_SIDED|90.0|-2.1|1.5|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 16.||1.5|-2.1|
71811974|NCT04270747|143126533|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-1.9|2.0|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 24.||2.0|-1.9|
71811975|NCT04270747|143126533|OTHER||Difference between means|-1.9|||||TWO_SIDED|90.0|-4.0|0.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 32.||0.2|-4.0|
71811976|NCT04270747|143126533|OTHER||Difference between means|0.0|||||TWO_SIDED|90.0|-2.2|2.2|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 40.||2.2|-2.2|
71811977|NCT04270747|143126533|OTHER||Difference between means|-0.6|||||TWO_SIDED|90.0|-2.9|1.7|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 48.||1.7|-2.9|
71811978|NCT04270747|143126533|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-3.5|1.1|||||Estimated using ANCOVA model adjusted for the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA as covariates.|Difference in mean change from Baseline at Week 52.||1.1|-3.5|
71811979|NCT04270747|143126534|OTHER||Risk Difference (RD)|-3.4|||||TWO_SIDED|90.0|-9.8|3.1|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 10 letters of vision at Week 8.||3.1|-9.8|
71811980|NCT04270747|143126535|OTHER||Risk Difference (RD)|-5.3|||||TWO_SIDED|90.0|-13.6|2.5|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||2.5|-13.6|
71676837|NCT03605862|142871803|SUPERIORITY|||||||0.9142|||||||Fisher Exact|||Comparison for study day 3||||0.9142
71676838|NCT03605862|142871803|SUPERIORITY|||||||0.0132|||||||Fisher Exact|||Comparison for study day 7||||0.0132
71676839|NCT03605862|142871804|SUPERIORITY|||||||0.1239|||||||t-test, 2 sided|||Comparison for day 2||||0.1239
71676840|NCT03605862|142871804|SUPERIORITY|||||||0.1022|||||||t-test, 2 sided|||Comparison for day 3||||0.1022
71676841|NCT03605862|142871804|SUPERIORITY|||||||0.46213|||||||t-test, 2 sided|||Comparison for day 7||||0.46213
71676842|NCT03605862|142871807|SUPERIORITY|||||||0.014|||||||Gehan-Wilcoxon|Analysis stratified by time from symptom onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0140
71676843|NCT03605862|142871808|SUPERIORITY|||||||0.0112|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||0.0112
71676844|NCT03605862|142871809|SUPERIORITY||||||<|0.0001|||||||Gehan-Wilcoxon|Analysis stratified by time from onset at first dose, pre-enrollment symptom relief medication use, and presence of underlying lung condition||||||<0.0001
71811981|NCT04270747|143126535|OTHER||Risk Difference (RD)|-5.2|||||TWO_SIDED|90.0|-14.4|4.2|||||Estimated using the stratified Newcombe confidence limits (with Mantel-Haenszel weights) adjusting for stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters).|Risk difference in percentage of participants who gained at least 15 letters of vision at Week 52.||4.2|-14.4|
71811982|NCT04270747|143126536|OTHER||Difference between means|-0.048|||||TWO_SIDED|90.0|-0.734|0.638|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.638|-0.734|
71811983|NCT04270747|143126536|OTHER||Difference between means|0.431|||||TWO_SIDED|90.0|-0.367|1.229|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.229|-0.367|
71895803|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.56|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.56|
71895804|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.54|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.69|0.54|
71895805|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.78|1.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.05|0.78|
71895806|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.59|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.80|0.59|
71811984|NCT04270747|143126536|OTHER||Difference between means|0.197|||||TWO_SIDED|90.0|-0.625|1.019|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||1.019|-0.625|
71811985|NCT04270747|143126536|OTHER||Difference between means|0.156|||||TWO_SIDED|2.0|-0.561|0.872|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||0.872|-0.561|
71895807|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.7|||||TWO_SIDED|95.0|0.53|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.83|0.53|
71895808|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.51|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||0.74|0.51|
71811986|NCT04270747|143126536|OTHER||Difference between means|0.105|||||TWO_SIDED|90.0|-0.682|0.891|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||0.891|-0.682|
71811987|NCT04270747|143126536|OTHER||Difference between means|0.245|||||TWO_SIDED|90.0|-0.667|1.158|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||1.158|-0.667|
71811988|NCT04270747|143126536|OTHER||Difference between means|-0.116|||||TWO_SIDED|90.0|-1.065|0.834|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||0.834|-1.065|
71811989|NCT04270747|143126536|OTHER||Difference between means|0.647|||||TWO_SIDED|90.0|-0.186|1.479|||||Estimated using ANCOVA model with treatment, Baseline CNV measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||1.479|-0.186|
71811990|NCT04270747|143126537|OTHER||Difference between means|6.2|||||TWO_SIDED|90.0|-5.6|17.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||17.9|-5.6|
71811991|NCT04270747|143126537|OTHER||Difference between means|1.3|||||TWO_SIDED|90.0|-11.0|13.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||13.5|-11.0|
71811992|NCT04270747|143126537|OTHER||Difference between means|1.9|||||TWO_SIDED|90.0|-12.9|16.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||16.6|-12.9|
71811993|NCT04270747|143126537|OTHER||Difference between means|0.1|||||TWO_SIDED|90.0|-14.1|14.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||14.4|-14.1|
71811994|NCT04270747|143126537|OTHER||Difference between means|-1.2|||||TWO_SIDED|90.0|-15.3|12.9|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||12.9|-15.3|
71811995|NCT04270747|143126537|OTHER||Difference between means|0.2|||||TWO_SIDED|90.0|-13.7|14.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||14.1|-13.7|
71811996|NCT04270747|143126537|OTHER||Difference between means|7.0|||||TWO_SIDED|90.0|-7.4|21.4|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||21.4|-7.4|
71811997|NCT04270747|143126537|OTHER||Difference between means|1.6|||||TWO_SIDED|2.0|-9.3|12.5|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||12.5|-9.3|
71811998|NCT04270747|143126537|OTHER||Difference between means|6.3|||||TWO_SIDED|90.0|-7.4|20.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 4.||20.0|-7.4|
71811999|NCT04270747|143126537|OTHER||Difference between means|-5.1|||||TWO_SIDED|90.0|-19.3|9.1|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 8.||9.1|-19.3|
71812000|NCT04270747|143126537|OTHER||Difference between means|-3.8|||||TWO_SIDED|90.0|-20.9|13.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 16.||13.3|-20.9|
71812001|NCT04270747|143126537|OTHER||Difference between means|-6.0|||||TWO_SIDED|90.0|-22.6|10.6|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 24.||10.6|-22.6|
71812002|NCT04270747|143126537|OTHER||Difference between means|-7.0|||||TWO_SIDED|90.0|-23.3|9.3|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 32.||9.3|-23.3|
71676845|NCT00937040|142871810|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject.|ANCOVA|P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16.||Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made.||||<0.001
71812003|NCT04270747|143126537|OTHER||Difference between means|-6.5|||||TWO_SIDED|90.0|-22.8|9.8|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 40.||9.8|-22.8|
71812004|NCT04270747|143126537|OTHER||Difference between means|-0.5|||||TWO_SIDED|90.0|-17.3|16.2|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 48.||16.2|-17.3|
71812005|NCT04270747|143126537|OTHER||Difference between means|2.3|||||TWO_SIDED|90.0|-10.5|15.0|||||Estimated using ANCOVA model with treatment, Baseline CST measurement and the stratification factors geographic region (East Asia, Europe, North America) and Baseline BCVA (BCVA \< 64 letters, BCVA ≥ 64 letters) as covariates.|Difference in mean change from Baseline at Week 52.||15.0|-10.5|
71812006|NCT05614089|143126582|SUPERIORITY|||||||0.43||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||6-month (primary)||||0.43
71812007|NCT05614089|143126582|SUPERIORITY|||||||0.008||||||Since this is one of two coprimary outcomes (this outcome and % time-in-range), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in serious hypoglycemia at baseline||12-month||||0.008
71812008|NCT05614089|143126583|SUPERIORITY|||||||0.71||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||6-month (primary)||||0.71
71812009|NCT05614089|143126583|SUPERIORITY|||||||0.64||||||Since this is one of two coprimary outcomes (this outcome and % time in serious hypoglycemia), a win (p\<0.025 for benefit) on either outcome will be considered to be a positive trial.|Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % TIR at baseline||12-month||||0.64
71812010|NCT05614089|143126584|SUPERIORITY|||||||0.54|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||6-month||||0.54
71812011|NCT05614089|143126584|SUPERIORITY|||||||0.07|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time in hypoglycemia at baseline||12-month||||0.07
71812012|NCT05614089|143126585|SUPERIORITY|||||||0.58|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||6-month||||0.58
71812013|NCT05614089|143126585|SUPERIORITY|||||||0.21|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and % time above range at baseline||12-month||||0.21
71812014|NCT05614089|143126586|SUPERIORITY|||||||0.7|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||6-month||||0.70
71812015|NCT05614089|143126586|SUPERIORITY|||||||0.02|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and number of nocturnal events at baseline||12-month||||0.02
71812016|NCT05614089|143126587|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||6-month||||0.81
71812017|NCT05614089|143126587|SUPERIORITY|||||||0.29|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and HbA1c at baseline||12-month||||0.29
71812018|NCT05614089|143126588|SUPERIORITY|||||||0.98|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.98
71812019|NCT05614089|143126588|SUPERIORITY|||||||0.61|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.61
71812020|NCT05614089|143126589|SUPERIORITY|||||||0.83|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 6-month||||0.83
71812021|NCT05614089|143126589|SUPERIORITY|||||||0.09|||||||Negative Binomial Regression|Negative binomial regression model adjusted for age at screening and study site||Through 12-month||||0.09
71812022|NCT05614089|143126590|SUPERIORITY|||||||0.95|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||6-month||||0.95
71676846|NCT00937040|142871811|SUPERIORITY_OR_OTHER|||||||0.206||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#02.||||0.206
71812023|NCT05614089|143126590|SUPERIORITY|||||||0.73|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Symptoms score at baseline||12-month||||0.73
71812024|NCT05614089|143126591|SUPERIORITY|||||||0.81|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||6-month||||0.81
71676847|NCT00937040|142871812|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#03.||||0.348
71812025|NCT05614089|143126591|SUPERIORITY|||||||0.44|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and PedsQL 3.2 DM Diabetes Management score at baseline||12-month||||0.44
71812026|NCT05614089|143126592|SUPERIORITY|||||||0.04|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||6-month||||0.04
71812027|NCT05614089|143126592|SUPERIORITY|||||||0.1|||||||Regression, Linear|Multivariable generalized linear regression model adjusted for age at screening, study site, and ITSQ at baseline||12-month||||0.10
71812028|NCT00386022|143126647|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH as a function of dose in young or old postmenopausal women|||||<|0.001||||||LH % change with dose|Repeated measures ANCOVA|||||||<0.001
71812029|NCT00386022|143126647|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the LH response to GnRH between younger and older postmenopausal women|||||<|0.03||||||LH % change with age|Repeated measures ANCOVA|||null hypothesis: there will be no difference in the LH and FSH responses to graded doses of GnRH between younger and older postmenopausal women||||<0.03
71812030|NCT00386022|143126647|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH as a function of dose in younger or older postmenopausal women|||||<|0.001||||||FSH % change with dose|Repeated measures ANCOVA|||||||<0.001
71812031|NCT00386022|143126647|EQUIVALENCE|null hypothesis will be accepted if there is no difference in the FSH response to GnRH between young and old postmenopausal women|||||<|0.005||||||FSH % change with age|Repeated measures ANCOVA|||||||<0.005
71812032|NCT00386022|143126648|EQUIVALENCE|null hypothesis will be accepted if there is no effect of estrogen on the LH response to GnRH in younger and older postmenopausal women|||||<|0.01||||||LH amplitude response with estrogen|Repeated measured ANCOVA|||||||<0.01
71812033|NCT00386022|143126648|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of estrogen on the FSH response to GnRH in younger and older postmenopausal women|||||<|0.0001||||||FSH amplitude response with estrogen|Repeated measures ANCOVA|||||||<0.0001
71812034|NCT00386022|143126648|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the FSH response to GnRH|||||<|0.02||||||FSH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||<0.02
71812035|NCT00386022|143126648|EQUIVALENCE|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the LH response to GnRH|||||=|0.4||||||LH amplitude response to estrogen with age|Repeated measures ANCOVA|||||||=0.4
71844614|NCT02307682|143202453|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.8|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.1|-5.8|
71844615|NCT02307682|143202453|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-6.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.1|-6.4|
71844616|NCT02307682|143202453|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-8.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.6|-8.7|
71844617|NCT02307682|143202453|OTHER||Difference in proportions|5.5|||||TWO_SIDED|95.0|0.3|10.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||10.7|0.3|
71812036|NCT03371082|143126650|EQUIVALENCE|The limits of the lower and upper equivalence margin were -11.3 and 11.3, respectively.|Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|90.0|-5.4|6.5|||||The asymptotic standard error was planned and is reported above.|This is a two-arm study.||6.5|-5.4|
71812037|NCT01064297|143126662|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.2||||||95.0|1.6|3.1|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.1|1.6|
71812038|NCT01064297|143126662|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|4.2||||||95.0|1.4|11.0|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||11.0|1.4|
71812039|NCT01064297|143126662|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.4||||||95.0|1.7|3.3|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||3.3|1.7|
71812040|NCT01064297|143126663|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|10.7||||||95.0|6.4|17.0||||||||17.0|6.4|
71676848|NCT00937040|142871813|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#04.||||0.324
71676849|NCT00937040|142871814|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#05.||||0.631
71844618|NCT02307682|143202453|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-3.2|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.2|-3.2|
71844619|NCT02307682|143202453|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.1|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.7|-6.1|
71844620|NCT02307682|143202453|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.0|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||1.9|-9.0|
71844621|NCT02307682|143202453|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.9|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.1|-1.9|
71844622|NCT02307682|143202453|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.9|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||6.4|-3.9|
71844623|NCT02307682|143202453|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.7|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-4.7|
71844624|NCT02307682|143202453|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-5.2|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-5.2|
71844625|NCT02307682|143202453|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.3|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||7.3|-3.3|
71844626|NCT02307682|143202453|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-5.7|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.8|-5.7|
71844627|NCT02307682|143202453|OTHER||Difference in proportions|3.9|||||TWO_SIDED|95.0|-1.7|9.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||9.7|-1.7|
71844628|NCT02307682|143202453|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-5.3|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||5.6|-5.3|
71895809|NCT01025336|143313925|SUPERIORITY_OR_OTHER||Geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.75|1.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.||1.15|0.75|
71676850|NCT00937040|142871815|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#06.||||<0.001
71844629|NCT02307682|143202453|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-1.3|8.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.9|-1.3|
71895810|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|6.05|10.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.67|6.05|
71895811|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.3|||||TWO_SIDED|95.0|6.65|10.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.45|6.65|
71676851|NCT00937040|142871816|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#07.||||<0.001
71812041|NCT01064297|143126663|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|9.3||||||95.0|5.5|15.2|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||15.2|5.5|
71812042|NCT01064297|143126664|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.5|5.0||||||||5.0|1.5|
71812043|NCT01064297|143126664|SUPERIORITY_OR_OTHER||Wilson Score with Continuity Correction|2.8||||||95.0|1.6|4.9|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).|||4.9|1.6|
71812044|NCT01542957|143126702|SUPERIORITY_OR_OTHER||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.69||0.6|TWO_SIDED|95.0|-3.35|1.43|||Mixed Models Analysis|||||1.43|-3.35|0.60
71812045|NCT01542957|143126703|SUPERIORITY_OR_OTHER||Slope|1.27|STANDARD_ERROR_OF_MEAN|0.53||0.21|TWO_SIDED|95.0|-0.71|3.25|||Mixed Models Analysis|||||3.25|-0.71|0.21
71812046|NCT01542957|143126704|SUPERIORITY_OR_OTHER||Slope|-0.01||||0.84|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.84
71812047|NCT00394355|143126725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.261|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way analysis of variance (ANOVA) model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.261
71812048|NCT00394355|143126725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.644|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.644
71812049|NCT00394355|143126726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.359
71812050|NCT00394355|143126726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.390
71812051|NCT00394355|143126727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.169
71812052|NCT00394355|143126727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.526|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."||||0.526
71812053|NCT00394355|143126728|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||<0.001
71812054|NCT00394355|143126728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.||||0.023
71812055|NCT01648348|143126731|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.57|TWO_SIDED|95.0|0.73|1.77|||Log Rank|||||1.77|0.73|0.57
71812056|NCT01648348|143126732|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71812057|NCT01648348|143126733|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.82|TWO_SIDED|95.0|0.66|1.69|||Log Rank|||||1.69|0.66|0.82
71812058|NCT01648348|143126735|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
71812059|NCT01648348|143126736|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Future uncertainty symptom scale/item t-test, 2-sided, unpooled.||||0.55
71812060|NCT01648348|143126736|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Visual disorder symptom scale/item t-test, 2-sided, unpooled.||||0.16
71812061|NCT01648348|143126736|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||Motor dysfunction symptom scale/item t-test, 2-sided, unpooled.||||0.99
71812062|NCT01648348|143126736|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Communication deficit symptom scale/item t-test, 2-sided, unpooled.||||0.75
71812063|NCT01648348|143126736|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Headaches symptom scale/item t-test, 2-sided, unpooled.||||0.17
71812064|NCT01648348|143126736|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||Seizures symptom scale/item t-test, 2-sided, unpooled.||||0.90
71812065|NCT01648348|143126736|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||Drowsiness symptom scale/item t-test, 2-sided, unpooled.||||0.82
71812066|NCT01648348|143126736|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Itchy skin symptom scale/item t-test, 2-sided, unpooled.||||0.15
71812067|NCT01648348|143126736|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Hair loss symptom scale/item t-test, 2-sided, unpooled.||||0.77
71812068|NCT01648348|143126736|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Weakness of legs symptom scale/item t-test, 2-sided, unpooled.||||0.10
71812069|NCT01648348|143126736|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Bladder control symptom scale/item t-test, 2-sided, unpooled.||||0.65
71812070|NCT01648348|143126737|SUPERIORITY|||||||0.83|||||||proportion test|||||||0.83
71812071|NCT01142388|143126765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on: 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.85
71812072|NCT01142388|143126766|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|TWO_SIDED||||||Log Rank|one-sided stratified log rank test, stratifying on 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.||||||0.50
71812073|NCT02597907|143126773|OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
71812074|NCT00297115|143126784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|58.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|41.0|75.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||75|41|<0.0001
71812075|NCT00297115|143126785|SUPERIORITY_OR_OTHER||Rate ratio|0.815|STANDARD_ERROR_OF_MEAN|0.057||0.0035|TWO_SIDED|95.0|0.71|0.935||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression|||||0.935|0.710|0.0035
71844630|NCT02307682|143202453|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-4.3|6.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||6.0|-4.3|
71844631|NCT02307682|143202453|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-6.4|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.2|-6.4|
71844632|NCT02307682|143202453|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-10.8|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.9|-10.8|
71844633|NCT02307682|143202454|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-7.7|
71844634|NCT02307682|143202454|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-11.4|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.4|-11.4|
71676852|NCT00937040|142871817|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#08.||||0.008
71676853|NCT00937040|142871818|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#09.||||0.372
71812076|NCT00297115|143126786|SUPERIORITY_OR_OTHER||Mean Difference (Net)|61.0|STANDARD_ERROR_OF_MEAN|9.0|<|0.0001|TWO_SIDED|95.0|44.0|79.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||79|44|<0.0001
71812077|NCT00297115|143126787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213|STANDARD_ERROR_OF_MEAN|0.35||0.5028|TWO_SIDED|95.0|0.689|2.137||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 772 in the roflumilast group, n= 796 in the placebo group).|||2.137|0.689|0.5028
71812078|NCT00297115|143126788|SUPERIORITY_OR_OTHER||Mean Difference calculated as ratio|1.0593||||0.3627|TWO_SIDED|95.0|0.9356|1.1994||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method||||1.1994|0.9356|0.3627
71812079|NCT00297115|143126789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|STANDARD_ERROR_OF_MEAN|0.104||0.0059|TWO_SIDED|95.0|0.082|0.489||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).||||0.489|0.082|0.0059
71812080|NCT02472652|143126806|OTHER||change in prolactin|30.0|||||TWO_SIDED|||||||||||||
71812081|NCT02713711|143126807|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.3262|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.3262
71812082|NCT02713711|143126807|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.01|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.01
71812083|NCT02713711|143126807|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.||||||0.0646|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||0.0646
71812084|NCT02713711|143126807|SUPERIORITY|ANOVA. Sample was calculated with power of 80% and alpha of 0.05.|||||<|0.001|||||||ANOVA|repeated measures ANOVA (Bonferroni post-test) for intragroup analysis||||||<0.001
71812085|NCT02713711|143126807|SUPERIORITY|Two-way ANOVA (Bonferroni post-test) for intergroup analysis.|||||<|0.001|||||||ANOVA|||||||<0.001
71812086|NCT02713711|143126808|SUPERIORITY|paired-t test (intragroup analysis)||||||0.208|||||||t-test, 2 sided|||||||0.2080
71812087|NCT02713711|143126808|SUPERIORITY|paired-t test (intragroup analysis)||||||0.0136|||||||t-test, 2 sided|||||||0.0136
71812088|NCT02713711|143126808|SUPERIORITY|paired-t test (intragroup analysis)||||||0.2987|||||||t-test, 2 sided|||||||0.2987
71812089|NCT02713711|143126808|SUPERIORITY|paired-t test (intragroup analysis)||||||0.8347|||||||t-test, 2 sided|||||||0.8347
71812090|NCT02713711|143126808|SUPERIORITY|two-way ANOVA with Bonferroni post hoc test (intergroup analysis)||||||0.0001|||||||ANOVA|||||||0.0001
71812091|NCT00998400|143126812|SUPERIORITY|||||||0.03|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.030
71812092|NCT00998400|143126813|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812093|NCT00998400|143126814|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812094|NCT00998400|143126815|SUPERIORITY||||||>|0.05|||||||Kaplan-Meier Survival analysis|||||||>0.05
71812095|NCT00998400|143126816|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812096|NCT00998400|143126817|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812097|NCT00998400|143126818|SUPERIORITY|||||||0.013|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||0.013
71812098|NCT00998400|143126819|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812099|NCT00998400|143126820|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812100|NCT00998400|143126821|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812101|NCT00998400|143126822|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71812102|NCT00998400|143126823|SUPERIORITY||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.||||||>0.05
71844635|NCT02307682|143202454|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.3|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.3|
71844636|NCT02307682|143202454|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-9.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.2|-9.8|
71844637|NCT02307682|143202454|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.5|-1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.5|-11.5|
71844638|NCT02307682|143202454|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-12.8|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.3|-12.8|
71812103|NCT05067439|143126842|OTHER||Ratio of Adjusted Geometric Means|288.81|||||TWO_SIDED|90.0|240.56|346.73||||||Omeprazole 10 mg was Reference and abrocitinib 200 mg + omeprazole 10 mg was Test. Natural log-transformed AUCinf was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||346.73|240.56|
71812104|NCT05067439|143126843|OTHER||Ratio of Adjusted Geometric Means|139.59|||||TWO_SIDED|90.0|121.98|159.74||||||Caffeine 100 mg was Reference and abrocitinib 200 mg + caffeine 100 mg was Test. Natural log-transformed AUCinfCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||159.74|121.98|
71844639|NCT02307682|143202454|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-11.8|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-1.1|-11.8|
71812105|NCT05067439|143126844|OTHER||Ratio of Adjusted Geometric Means|110.1|||||TWO_SIDED|90.0|103.45|117.17||||||Efavirenz 50 mg was Reference and abrocitinib 200 mg + efavirenz 50 mg was Test. Natural log-transformed AUClastCR was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect and estimates of the adjusted mean differences (Test-Reference) and 90% CIs were obtained. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CI.||117.17|103.45|
71812106|NCT00335452|143126875|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|6.1||||0.3037|TWO_SIDED|95.0|-5.8|16.6||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||16.6|-5.8|0.3037
71812107|NCT00335452|143126876|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).||||||0.012
71812108|NCT00335452|143126877|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|3.1||||0.6047|TWO_SIDED|95.0|-9.2|14.0||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.|The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.|||14.0|-9.2|0.6047
71812109|NCT00335452|143126878|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|-6.5||||0.4579|TWO_SIDED|95.0|-26.0|9.9||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||9.9|-26.0|0.4579
71812110|NCT00335452|143126878|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|17.6||||0.0262|TWO_SIDED|95.0|2.2|30.5||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.|||30.5|2.2|0.0262
71812111|NCT00335452|143126878|SUPERIORITY_OR_OTHER|||||||0.0355||95.0||||The a priori threshold for statistical significance is ≤0.05.|Chi-squared|Interaction chi-squared test of the Cox proportional hazards model.||||||0.0355
71812112|NCT00335452|143126879|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|14.7||||0.0332|TWO_SIDED|95.0|1.2|26.3||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||26.3|1.2|0.0332
71844640|NCT02307682|143202454|OTHER||Difference in proportions|-8.6|||||TWO_SIDED|95.0|-14.4|-2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.9|-14.4|
71812113|NCT00335452|143126880|SUPERIORITY_OR_OTHER|||||||0.945||95.0||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).||||||0.945
71812114|NCT00335452|143126881|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|32.6||||0.0004|TWO_SIDED|95.0|16.2|45.8||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.|||45.8|16.2|0.0004
71812115|NCT01904864|143126882|SUPERIORITY||Mean Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.6|||Regression, Linear||Change at 12 weeks compared|||1.6|0.4|<0.001
71812116|NCT02093663|143126923|OTHER||Odds Ratio (OR)|3.21||||0.039|TWO_SIDED|95.0|1.04|9.88|||Uncorrected Chi-squared Test|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (last observation carried forward \[LOCF\] and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||9.88|1.04|0.039
71812117|NCT02093663|143126924|OTHER||Odds Ratio (OR)|0.99||||0.981|TWO_SIDED|95.0|0.42|2.34||P-value were based on a Cochran-Mantel-Haenszel test stratified by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-value s were presented as descriptive statistics.||2.34|0.42|0.981
71844641|NCT02307682|143202454|OTHER||Difference in proportions|2.7|||||TWO_SIDED|95.0|-2.8|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||8.3|-2.8|
71844642|NCT02307682|143202454|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-3.4|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.5|-3.4|
71844643|NCT02307682|143202454|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-9.7|0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||0.9|-9.7|
71844644|NCT02307682|143202454|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.3|-1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-1.3|-12.3|
71844645|NCT02307682|143202454|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-4.2|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.2|-4.2|
71844646|NCT02307682|143202454|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-8.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||1.7|-8.4|
71844647|NCT02307682|143202454|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-6.2|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.2|-6.2|
71844648|NCT02307682|143202454|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-7.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.4|-7.5|
71844649|NCT02307682|143202454|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-9.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.7|-9.5|
71844650|NCT02307682|143202454|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.6|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.6|-10.6|
71844651|NCT02307682|143202454|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-10.2|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.3|-10.2|
71844652|NCT02307682|143202454|OTHER||Difference in proportions|-6.3|||||TWO_SIDED|95.0|-12.2|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.8|-12.2|
71844653|NCT02307682|143202454|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.6|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.3|-6.6|
71844654|NCT02307682|143202454|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||0.1|-10.0|
71844655|NCT02307682|143202454|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.4|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||1.4|-9.4|
71844656|NCT02307682|143202454|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-13.6|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-2.7|-13.6|
71895812|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.8|||||TWO_SIDED|95.0|3.71|6.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.14|3.71|
71895813|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.2|||||TWO_SIDED|95.0|2.59|3.91|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.91|2.59|
71895814|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.4|||||TWO_SIDED|95.0|3.67|5.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.26|3.67|
71895815|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|2.2|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.20|
71895816|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.9|||||TWO_SIDED|95.0|7.8|21.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.34|7.80|
71895817|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|6.26|12.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||12.92|6.26|
71844657|NCT02307682|143202454|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.1|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-5.1|
71844658|NCT02307682|143202454|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.2|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.8|-6.2|
71844659|NCT02307682|143202454|OTHER||Difference in proportions|-4.2|||||TWO_SIDED|95.0|-9.4|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||1.2|-9.4|
71844660|NCT02307682|143202454|OTHER||Difference in proportions|-6.2|||||TWO_SIDED|95.0|-11.5|-0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-0.8|-11.5|
71895818|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.5|||||TWO_SIDED|95.0|3.71|8.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.07|3.71|
71895819|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.2|||||TWO_SIDED|95.0|4.35|8.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.80|4.35|
71895820|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|9.71|16.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.30|9.71|
71676854|NCT00937040|142871819|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#10.||||<0.001
71676855|NCT00937040|142871820|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value was determined using CMH general association controlling for pooled center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#11.||||0.008
71844661|NCT02307682|143202454|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-7.3|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.0|-7.3|
71895821|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.5|||||TWO_SIDED|95.0|5.59|10.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.02|5.59|
71895822|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.1|||||TWO_SIDED|95.0|9.56|23.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.81|9.56|
71676856|NCT00937040|142871821|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#12.||||<0.001
71676857|NCT00937040|142871822|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#13.||||0.003
71676858|NCT00937040|142871823|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#14.||||0.016
71812118|NCT02093663|143126925|OTHER||Difference in proportions|50.0||||0.4|TWO_SIDED|95.0|-19.3|100.0||P-value was calculated based on Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||100.0|-19.3|0.400
71844662|NCT02307682|143202454|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-7.9|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.1|-7.9|
71844663|NCT02307682|143202454|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-10.5|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.7|-10.5|
71844664|NCT02307682|143202454|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-12.5|-1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-1.8|-12.5|
71844665|NCT02307682|143202454|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-6.0|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.0|-6.0|
71844666|NCT02307682|143202454|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.3|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.9|-6.3|
71895823|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.3|||||TWO_SIDED|95.0|8.66|17.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.38|8.66|
71895824|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.29|9.89|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.89|4.29|
71895825|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.8|||||TWO_SIDED|95.0|12.59|34.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||34.24|12.59|
71895826|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|21.4|||||TWO_SIDED|95.0|14.56|31.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||31.46|14.56|
71812119|NCT02093663|143126926|OTHER||Difference in proportions|50.0||||0.333|TWO_SIDED|95.0|-19.3|100.0||P-value was based on a Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate.||100.0|-19.3|0.333
71812120|NCT02093663|143126927|OTHER||Difference in Least squares Mean|-5.4||||0.168|TWO_SIDED|95.0|-13.1|2.4||P-value is based on an analysis of covariance (ANCOVA) including treatment arm as a factor and baseline DUCS score as a covariate.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||2.4|-13.1|0.168
71844667|NCT02307682|143202454|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.1|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-0.4|-10.1|
71844668|NCT02307682|143202454|OTHER||Difference in proportions|-7.3|||||TWO_SIDED|95.0|-12.2|-2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-2.3|-12.2|
71895827|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|7.24|17.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||17.01|7.24|
71844669|NCT02307682|143202454|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-5.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.3|-5.2|
71844670|NCT02307682|143202454|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||3.5|-5.8|
71844671|NCT02307682|143202454|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-8.4|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.8|-8.4|
71844672|NCT02307682|143202454|OTHER||Difference in proportions|-3.3|||||TWO_SIDED|95.0|-8.5|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||1.5|-8.5|
71844673|NCT02307682|143202454|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-9.8|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.2|-9.8|
71844674|NCT02307682|143202454|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-10.4|-0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||-0.7|-10.4|
71844675|NCT02307682|143202454|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-7.4|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.0|-7.4|
71844676|NCT02307682|143202454|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.0|-1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-1.1|-11.0|
71844677|NCT02307682|143202454|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.9|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.1|-4.9|
71844678|NCT02307682|143202454|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-7.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||1.4|-7.6|
71844679|NCT02307682|143202454|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.3|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||5.1|-5.3|
71844680|NCT02307682|143202454|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-8.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.8|-8.5|
71676859|NCT00937040|142871824|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#15.||||0.092
71844681|NCT02307682|143202455|OTHER||Difference in proportions|-6.7|||||TWO_SIDED|95.0|-14.1|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.1|
71844682|NCT02307682|143202455|OTHER||Difference in proportions|-7.4|||||TWO_SIDED|95.0|-15.3|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-15.3|
71844683|NCT02307682|143202455|OTHER||Difference in proportions|-9.3|||||TWO_SIDED|95.0|-16.6|-2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.2|-16.6|
71844684|NCT02307682|143202455|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.7|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-5.4|-19.7|
71844685|NCT02307682|143202455|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-14.8|-1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.6|-14.8|
71844686|NCT02307682|143202455|OTHER||Difference in proportions|-10.2|||||TWO_SIDED|95.0|-17.4|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-3.9|-17.4|
71844687|NCT02307682|143202455|SUPERIORITY||Difference in proportions|-10.2||||0.003|TWO_SIDED|95.0|-17.3|-2.5||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.5|-17.3|0.0030
71844688|NCT02307682|143202455|SUPERIORITY||Difference in proportions|-18.2|||<|0.0001|TWO_SIDED|95.0|-25.3|-10.9||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-10.9|-25.3|<0.0001
71844689|NCT02307682|143202455|OTHER||Difference in proportions|12.0|||||TWO_SIDED|95.0|5.2|19.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||19.0|5.2|
71844690|NCT02307682|143202455|OTHER||Difference in proportions|11.1|||||TWO_SIDED|95.0|3.8|18.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||18.2|3.8|
71844691|NCT02307682|143202455|OTHER||Difference in proportions|-10.6|||||TWO_SIDED|95.0|-17.7|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-17.7|
71844692|NCT02307682|143202455|OTHER||Difference in proportions|-23.2|||||TWO_SIDED|95.0|-30.5|-16.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-16.1|-30.5|
71844693|NCT02307682|143202455|OTHER||Difference in proportions|1.7|||||TWO_SIDED|95.0|-4.8|9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||9.0|-4.8|
71844694|NCT02307682|143202455|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-11.8|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-11.8|
71844695|NCT02307682|143202455|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-12.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.1|-12.0|
71844696|NCT02307682|143202455|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-18.0|-3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.2|-18.0|
71844697|NCT02307682|143202455|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.5|0.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||0.8|-12.5|
71844698|NCT02307682|143202455|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-16.2|-2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.4|-16.2|
71844699|NCT02307682|143202455|OTHER||Difference in proportions|-8.2|||||TWO_SIDED|95.0|-15.7|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.6|-15.7|
71844700|NCT02307682|143202455|OTHER||Difference in proportions|-13.0|||||TWO_SIDED|95.0|-20.5|-5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-5.5|-20.5|
71844701|NCT02307682|143202455|OTHER||Difference in proportions|6.0|||||TWO_SIDED|95.0|-0.8|13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||13.0|-0.8|
71844702|NCT02307682|143202455|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-7.5|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.6|-7.5|
71844703|NCT02307682|143202455|SUPERIORITY||Difference in proportions|-10.5||||0.002|TWO_SIDED|95.0|-17.4|-3.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.3|-17.4|0.0020
71844704|NCT02307682|143202455|SUPERIORITY||Difference in proportions|-13.5||||0.0001|TWO_SIDED|95.0|-20.7|-6.1||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-6.1|-20.7|0.0001
71844705|NCT02307682|143202455|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-5.4|8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||8.1|-5.4|
71844706|NCT02307682|143202455|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.8|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||1.2|-11.8|
71844707|NCT02307682|143202455|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.3|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.7|-10.3|
71844708|NCT02307682|143202455|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.1|0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.4|-14.1|
71844709|NCT02307682|143202455|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.3|-10.1|
71844710|NCT02307682|143202455|OTHER||Difference in proportions|-7.1|||||TWO_SIDED|95.0|-14.0|-0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.6|-14.0|
71844711|NCT02307682|143202455|OTHER||Difference in proportions|-7.6|||||TWO_SIDED|95.0|-14.7|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-0.1|-14.7|
71844712|NCT02307682|143202455|OTHER||Difference in proportions|-12.1|||||TWO_SIDED|95.0|-19.5|-5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-5.4|-19.5|
71844713|NCT02307682|143202455|OTHER||Difference in proportions|7.2|||||TWO_SIDED|95.0|0.3|13.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||13.5|0.3|
71844714|NCT02307682|143202455|OTHER||Difference in proportions|2.2|||||TWO_SIDED|95.0|-4.9|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||8.4|-4.9|
71844715|NCT02307682|143202455|OTHER||Difference in proportions|-8.9|||||TWO_SIDED|95.0|-15.7|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.7|-15.7|
71844716|NCT02307682|143202455|OTHER||Difference in proportions|-12.5|||||TWO_SIDED|95.0|-19.8|-5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-5.6|-19.8|
71844717|NCT02307682|143202455|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.9|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-5.9|
71844718|NCT02307682|143202455|OTHER||Difference in proportions|-3.4|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||2.6|-9.8|
71844719|NCT02307682|143202455|OTHER||Difference in proportions|-4.4|||||TWO_SIDED|95.0|-11.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||2.5|-11.2|
71844720|NCT02307682|143202455|OTHER||Difference in proportions|-8.1|||||TWO_SIDED|95.0|-15.3|-1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-1.0|-15.3|
71844721|NCT02307682|143202455|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.9|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.6|-8.9|
71844722|NCT02307682|143202455|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.2|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||1.7|-11.2|
71844723|NCT02307682|143202455|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.8|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.7|-10.8|
71844724|NCT02307682|143202455|OTHER||Difference in proportions|-10.3|||||TWO_SIDED|95.0|-17.3|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-3.5|-17.3|
71844725|NCT02307682|143202455|OTHER||Difference in proportions|4.1|||||TWO_SIDED|95.0|-2.3|11.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||11.0|-2.3|
71844726|NCT02307682|143202455|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.8|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-9.8|
71844727|NCT02307682|143202455|OTHER||Difference in proportions|-6.4|||||TWO_SIDED|95.0|-13.2|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||0.7|-13.2|
71844728|NCT02307682|143202455|OTHER||Difference in proportions|-12.9|||||TWO_SIDED|95.0|-19.7|-6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-6.6|-19.7|
71844729|NCT02307682|143202456|SUPERIORITY|||||||0.0574||||||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0574
71844730|NCT02307682|143202456|SUPERIORITY|||||||0.0012||||||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (\<75, ≥75 years) and baseline fluid status)||||||0.0012
71812121|NCT02093663|143126928|OTHER||Difference in proportions|24.5||||0.131|TWO_SIDED|95.0|-1.6|50.6||P-value was based on a continuity-corrected chi-squared test. PUCAI Score was compared between treatment arms using a continuity corrected chi-squared test. Expected cell counts are very low (\< 5), then Fisher's Exact Test is alternative method.|Chi-squared, Corrected|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||50.6|-1.6|0.131
71895828|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.2|||||TWO_SIDED|95.0|19.75|52.57|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||52.57|19.75|
71895829|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|47.2|||||TWO_SIDED|95.0|34.0|65.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||65.43|34.00|
71895830|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.4|||||TWO_SIDED|95.0|12.95|29.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||29.17|12.95|
71812122|NCT02093663|143126929|OTHER||Difference in Proportions Percentage|-6.5||||0.539|TWO_SIDED|95.0|-25.3|12.3||P-value is based on a CMH test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||12.3|-25.3|0.539
71895831|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|7.79|21.13|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||21.13|7.79|
71895832|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.6|||||TWO_SIDED|95.0|8.56|18.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.68|8.56|
71895833|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.8|||||TWO_SIDED|95.0|4.54|10.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.10|4.54|
71895834|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.8|||||TWO_SIDED|95.0|8.16|20.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||20.02|8.16|
71812123|NCT02093663|143126930|OTHER||Difference in proportions|-16.2||||0.129|TWO_SIDED|95.0|-36.0|3.6||P-value was based on a Cochran-Mantel-Haenszel (CMH) test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||3.6|-36.0|0.129
71895835|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.15|16.23|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.23|8.15|
71895836|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.75|11.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.25|5.75|
71895837|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|20.0|||||TWO_SIDED|95.0|12.99|30.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.76|12.99|
71895838|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.3|||||TWO_SIDED|95.0|16.5|30.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||30.06|16.50|
71895839|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.8|||||TWO_SIDED|95.0|7.07|13.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||13.63|7.07|
71895840|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|8.82|16.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.34|8.82|
71895841|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.0|||||TWO_SIDED|95.0|10.21|16.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.66|10.21|
71676860|NCT00937040|142871825|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center. Missing/unknown responses are not included in the p-value.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#16.||||0.284
71676861|NCT00937040|142871826|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||<0.001
71676862|NCT00937040|142871827|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.319
71676863|NCT00937040|142871828|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint||||0.007
71676864|NCT02120833|142871944|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71844731|NCT02307682|143202457|SUPERIORITY||difference in proportions|-6.5||||0.0331|TWO_SIDED|95.0|-13.2|0.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||0.3|-13.2|0.0331
71844732|NCT02307682|143202457|SUPERIORITY||difference in proportions|-10.5||||0.0013|TWO_SIDED|95.0|-17.1|-3.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (\<75, \>=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.|||-3.5|-17.1|0.0013
71844733|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|0.9|||||TWO_SIDED|95.0|-0.5|2.3||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24||2.3|-0.5|
71844734|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|0.63|||||TWO_SIDED|95.0|-0.9|2.1||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||2.1|-0.9|
71844735|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|-0.2|||||TWO_SIDED|95.0|-1.8|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48||1.4|-1.8|
71844736|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|-0.26|||||TWO_SIDED|95.0|-1.9|1.4||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.4|-1.9|
71676865|NCT02120833|142871944|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.4360
71676866|NCT02120833|142871944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.62||0.051|TWO_SIDED|95.0|-2.51|0.01||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.01|-2.51|0.0510
71676867|NCT02120833|142871945|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0004
71676868|NCT02120833|142871945|SUPERIORITY_OR_OTHER|||||||0.0213|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0213
71676869|NCT02120833|142871945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.22||0.7698|TWO_SIDED|95.0|-0.5|0.37|||ANCOVA|The significance threshold level was 0.05 (two-sided).||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.37|-0.50|0.7698
71676870|NCT02120833|142871946|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0003
71676871|NCT02120833|142871946|SUPERIORITY_OR_OTHER|||||||0.6063|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6063
71676872|NCT02120833|142871946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.43||0.3686|TWO_SIDED|95.0|-1.27|0.48||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-1.27|0.3686
71676873|NCT02120833|142871947|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71676874|NCT02120833|142871947|SUPERIORITY_OR_OTHER|||||||0.6118|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6118
71895842|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|5.86|9.94|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.94|5.86|
71895843|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.2|||||TWO_SIDED|95.0|8.05|18.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.34|8.05|
71895844|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.2|||||TWO_SIDED|95.0|12.77|23.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||23.24|12.77|
71895845|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.5|||||TWO_SIDED|95.0|8.01|16.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.45|8.01|
71895846|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|12.0|||||TWO_SIDED|95.0|7.89|18.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||18.19|7.89|
71895847|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.7|||||TWO_SIDED|95.0|5.02|8.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.92|5.02|
71895848|NCT01025336|143313926|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.7|||||TWO_SIDED|95.0|3.52|6.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.29|3.52|
71895849|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.7|||||TWO_SIDED|95.0|3.05|4.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.49|3.05|
71895850|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.3|||||TWO_SIDED|95.0|1.92|2.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.81|1.92|
71895851|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.83|2.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||2.50|1.83|
71895852|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.5|||||TWO_SIDED|95.0|1.32|1.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||1.74|1.32|
71895853|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.0|||||TWO_SIDED|95.0|5.82|11.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||11.09|5.82|
71895854|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.25|8.21|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||8.21|4.25|
71895855|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.9|||||TWO_SIDED|95.0|3.96|6.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||6.00|3.96|
71895856|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.58|3.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.79|2.58|
71895857|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.9|||||TWO_SIDED|95.0|8.56|16.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||16.49|8.56|
71895858|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.5|||||TWO_SIDED|95.0|2.59|4.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.76|2.59|
71895859|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.5|||||TWO_SIDED|95.0|4.61|9.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.03|4.61|
71895860|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.1|||||TWO_SIDED|95.0|2.32|4.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.24|2.32|
71895861|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.4|||||TWO_SIDED|95.0|5.23|10.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||10.33|5.23|
71895862|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.6|||||TWO_SIDED|95.0|4.07|7.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.69|4.07|
71895863|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.5|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|2.50|
71895864|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.1|4.04|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||4.04|2.10|
71895865|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.9|||||TWO_SIDED|95.0|2.26|3.71|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.71|2.26|
71895866|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.23|3.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.63|2.23|
71895867|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.1|||||TWO_SIDED|95.0|3.16|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.20|3.16|
71895868|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.5|||||TWO_SIDED|95.0|2.06|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.14|2.06|
71895869|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.0|||||TWO_SIDED|95.0|2.46|3.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.60|2.46|
71895870|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.7|||||TWO_SIDED|95.0|2.24|3.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.15|2.24|
71895871|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.9|||||TWO_SIDED|95.0|4.55|7.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||7.76|4.55|
71895872|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.0|||||TWO_SIDED|95.0|3.13|5.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||5.17|3.13|
71895873|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.9|||||TWO_SIDED|95.0|5.16|9.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||9.25|5.16|
71895874|NCT01025336|143313927|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.8|||||TWO_SIDED|95.0|2.24|3.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.||3.40|2.24|
71895875|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.08|1.02|
71895876|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.14|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.99|1.14|
71812124|NCT02093663|143126931|OTHER||Difference in Least squares Mean|3.0||||0.182|TWO_SIDED|95.0|-1.4|7.4||P-value was based on an analysis of covariance (ANCOVA) including treatment arm and with prior response status.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||7.4|-1.4|0.182
71812125|NCT02093663|143126932|OTHER||Difference in proportions|-9.0||||0.194|TWO_SIDED|95.0|-29.1|11.0||P-value was based on a CMH test adjusted by prior response status. Participants with remission (PUCAI \<10) at double-blind maintenance phase at Week 26 was compared between treatment arms using a CMH test stratifying by Week 8 responder status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.||11.0|-29.1|0.194
71812126|NCT00508404|143126933|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|1.02|4.45|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||4.45|1.02|
71812127|NCT00508404|143126934|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.86|||||TWO_SIDED|95.0|0.88|3.93|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.93|0.88|
71812128|NCT00508404|143126935|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.3|3.89|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.|||3.89|0.30|
71812129|NCT00508404|143126936|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.283|||||TWO_SIDED|95.0|0.13|0.614|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.614|0.130|
71812130|NCT00508404|143126937|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.642|||||TWO_SIDED|95.0|0.99|2.721|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||2.721|0.990|
71812131|NCT00508404|143126938|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.464|||||TWO_SIDED|95.0|0.306|0.703|||||Hazard ratio presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.703|0.306|
71812132|NCT00508404|143126939|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.395|||||TWO_SIDED|95.0|0.252|0.618|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||0.618|0.252|
71812133|NCT00508404|143126940|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.756|||||TWO_SIDED|95.0|0.4|1.43|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.430|0.400|
71812134|NCT00508404|143126941|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.503|1.002|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value \< 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.|||1.002|0.503|
71812135|NCT00508404|143126943|SUPERIORITY_OR_OTHER_LEGACY||Difference in rates|8.34|||||TWO_SIDED|95.0|-4.01|19.08||||||||19.08|-4.01|
71812136|NCT03662074|143126944|OTHER||||||||||||||||||The pre-specified analysis plan as per the protocol is to proceed to the second stage of recruitment for additional participants if the response proportion exceeds the historical control of 10%.|||
71812137|NCT00643123|143126968|OTHER||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|2.3||0.45|TWO_SIDED||||||t-test, 2 sided|||||||.45
71812138|NCT01591382|143126978|SUPERIORITY_OR_OTHER|||||||0.0241||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.0241
71812139|NCT01591382|143126979|SUPERIORITY_OR_OTHER|||||||0.4102||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.4102
71812140|NCT01591382|143126980|SUPERIORITY_OR_OTHER|||||||0.1085||||||A P-value of \<0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)|||||||0.1085
71812141|NCT01591382|143126981|SUPERIORITY_OR_OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.7480
71812142|NCT00855062|143126991|SUPERIORITY_OR_OTHER||Slope|-0.026|STANDARD_ERROR_OF_MEAN|0.248||0.37|TWO_SIDED|95.0|-0.512|0.46||The p-value was not adjusted for multiple comparisons.|Regression, Linear|||"The null hypothesis was that the 24-week changes of U NP Sum between the minocycline and placebo groups are the same.~The sample size calculation showed that 100 (50 participants in each group) were required to detect the clinically meaningful difference of 0.5 with 85% power, 0.05 Type I error, two-sample and two-sided test."||0.460|-0.512|0.370
71812143|NCT00855062|143126993|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.053||||0.613|TWO_SIDED|95.0|0.043|0.062||The p-value is not adjusted for multiple comparisons.|Fisher Exact|||"The null hypothesis is that the percentage of participants feeling better in the minocycline group after 24 week treatment is the same as the one in the placebo group."||0.062|0.043|0.613
71812144|NCT00855062|143126994|SUPERIORITY_OR_OTHER|||||||0.661||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.661
71812145|NCT00855062|143126995|SUPERIORITY_OR_OTHER|||||||0.941||95.0||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the 48-week survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.||||0.941
71812146|NCT00855062|143126996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.11|STANDARD_ERROR_OF_MEAN|17.63||0.647|TWO_SIDED|95.0|-27.23|43.45||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 24-week change of CD4 cell counts in the minocycline group is the same as the one in the placebo group.||43.45|-27.23|0.647
71812147|NCT00855062|143126997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.77|STANDARD_ERROR_OF_MEAN|32.51||0.813|TWO_SIDED|95.0|-59.07|74.6||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 48-week change in CD4 cell counts in the minocycline group is the same as the one in the placebo group.||74.60|-59.07|0.813
71812148|NCT00855062|143126998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|STANDARD_ERROR_OF_MEAN|0.82||0.764||95.0|0.26|6.34||The p-value is not adjusted for multiple comparisons.|Regression, Logistic|"The model was not adjusted for any covariate (due to small number of being better in both groups."||"The null hypothesis is that the percentage of being better at week 24 compared to baseline in the minocycline group is the same as the one in the placebo group."||6.34|0.26|0.764
71812149|NCT00855062|143126999|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||The p-value is not adjusted for multiple comparisons.|Kruskal-Wallis|The chi-square score was 0.024 and the degree of freedom was 1.||The null hypothesis is that the median log10-transformed HIV RNA viral loads in the minocycline group is the same as the one in the placebo group.||||0.766
71812150|NCT00855062|143127000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|1.79||0.915|TWO_SIDED|95.0|-3.4|3.78||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CES-D and MSK scores.||The null hypothesis is that the mean 24-week change of CES-D score in the minocycline group is the same as the one in the placebo group.||3.78|-3.40|0.915
71812151|NCT02634788|143127012|OTHER||LS Mean Difference|81.93|STANDARD_ERROR_OF_MEAN|14.283|<|0.0001|TWO_SIDED|95.0|53.82|110.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||110.04|53.82|<0.0001
71812152|NCT02634788|143127012|OTHER||LS Mean Difference|36.18|STANDARD_ERROR_OF_MEAN|14.099||0.0108|TWO_SIDED|95.0|8.43|63.93|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.93|8.43|0.0108
71812153|NCT02634788|143127012|OTHER||LS Mean Difference|35.46|STANDARD_ERROR_OF_MEAN|14.02||0.012|TWO_SIDED|95.0|7.86|63.05|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||63.05|7.86|0.0120
71812154|NCT02277990|143127033|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0406|TWO_SIDED|95.12|0.36|0.98||The 0.05 critical value for assessing the primary endpoint was adjusted to 0.0488, to account for a planned interim analysis.|Regression, Cox|The Cox regression was stratified according to device type (pacemaker or CRT-P vs. ICD or CRT-D).||||0.98|0.36|0.0406
71812155|NCT02277990|143127034|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0248|TWO_SIDED|95.12|0.47|0.96|||Regression, Cox|||||0.96|0.47|0.0248
71812156|NCT02277990|143127035|NON_INFERIORITY|The non-inferiority test was performed on the as-treated cohort, per the statistical analysis plan. The non-inferiority margin for the hazard ratio was 1.33 (i.e., the hazard ratio for complications in the envelope group vs. the control group must be significantly lower than 1.33).|Hazard Ratio (HR)|0.93|||<|0.01|TWO_SIDED|95.12|0.77|1.12|||Regression, Cox|||||1.12|0.77|<0.01
71812157|NCT02277990|143127036|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0402|TWO_SIDED|95.12|0.4|0.98|||Regression, Cox|||||0.98|0.40|0.0402
71895877|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.22|3.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.06|1.22|
71895878|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|1.15|2.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.56|1.15|
71895879|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.36|3.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.53|1.36|
71895880|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.15|2.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.91|1.15|
71895881|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|2.8|||||TWO_SIDED|95.0|1.8|4.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.44|1.80|
71895882|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.7|||||TWO_SIDED|95.0|0.99|2.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.96|0.99|
71895883|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.1|||||TWO_SIDED|95.0|0.73|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.62|0.73|
71812158|NCT04711603|143127037|SUPERIORITY||Placebo difference|-0.97|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-1.52|-0.42|||MMRM|||||-0.42|-1.52|<0.001
71812159|NCT03138733|143127040|NON_INFERIORITY|The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two sided 95% CI for the difference in response rates in the mITT population was greater than -15%, the non-inferiority of ceftobiprole to daptomycin therapy was to be concluded.|Adjusted proportion difference|2.0|||||TWO_SIDED|95.0|-7.1|11.1||||||The observed difference in percentage of responders at PTE (ceftobiprole group minus the daptomycin group) were determined and a two-sided 95% confidence interval (CI) for the observed difference was computed, with adjustment for actual stratum (dialysis status and prior antibacterial treatment use). Cochran-Mantel-Haenszel (CMH) weights were used for the stratum weight in the calculation of the CI||11.1|-7.1|
71812160|NCT03138733|143127041|OTHER||Adjusted proportion difference|0.6|||||TWO_SIDED|95.0|-8.3|9.5|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||9.5|-8.3|
71812161|NCT03138733|143127042|OTHER||Adjusted proportion difference|5.1|||||TWO_SIDED|95.0|-2.9|13.0|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||13|-2.9|
71812162|NCT03138733|143127043|OTHER||Adjusted proportion difference|-0.5|||||TWO_SIDED|95.0|-6.2|5.2|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||5.2|-6.2|
71812163|NCT03138733|143127044|OTHER||Adjusted proportion difference|0.1|||||TWO_SIDED|95.0|-4.6|4.8|||||The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)|||4.8|-4.6|
71812164|NCT02612064|143127057|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.18||||0.1575|TWO_SIDED|95.0|-0.442|0.072|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as a factor and baseline Schiff sensitivity as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||0.072|-0.442|0.1575
71812165|NCT04058353|143127083|SUPERIORITY||Least Squares (LS) Mean Difference|3.5|||<|0.0001|TWO_SIDED|95.0|2.2|4.7|||Mixed-effects model for repeated measure|||||4.7|2.2|<0.0001
71812166|NCT04058353|143127084|SUPERIORITY||LS Mean Difference|-23.1|||<|0.0001|TWO_SIDED|95.0|-26.1|-20.1|||Mixed-effects model for repeated measure|||||-20.1|-26.1|<0.0001
71812167|NCT04058353|143127086|SUPERIORITY||LS Mean Difference|8.7|||<|0.0001|TWO_SIDED|95.0|5.3|12.1|||Mixed-effects model for repeated measure|||||12.1|5.3|<0.0001
71676875|NCT02120833|142871947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.56||0.1485|TWO_SIDED|95.0|-1.98|0.31||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.98|0.1485
71812168|NCT02618616|143127094|OTHER||least square difference|8.7||||0.8495|ONE_SIDED|90.0|8.4|||The 1-sided p-value tests if the ZPL-389 Least square (LS) mean is \< the placebo LS mean.|ANCOVA|||ANCOVA of PASI at Week 12|||8.4|0.8495
71812169|NCT02618616|143127095|OTHER||Odds Ratio (OR)|0.562||||0.9058|TWO_SIDED|90.0|0.27|1.16|||Regression, Logistic|||Logistic Regression PASI-50||1.16|0.27|0.9058
71812170|NCT02618616|143127095|OTHER||Odds Ratio (OR)|0.946||||0.5422|TWO_SIDED|90.0|0.4|2.25|||Regression, Logistic|||Logistic Regression PASI-75||2.25|0.4|0.5422
71812171|NCT05361655|143127113|OTHER||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.65|0.87|||Cox proportional hazard model|||||0.87|0.65|<0.0001
71812172|NCT05361655|143127114|OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.62|0.76|||Cox proportional hazards model|||||0.76|0.62|<0.0001
71812173|NCT05361655|143127116|OTHER||||||<|0.0001|||||||score test|||||||<0.0001
71812174|NCT05361655|143127119|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.6|0.72|||Cox proportional hazard model|||||0.72|0.60|<0.0001
71812175|NCT05361655|143127120|OTHER||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.51|0.62|||Cox proportional hazard model|||||0.62|0.51|<0.0001
71812176|NCT05361655|143127121|OTHER||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86|||Cox proportional hazard model|||||0.86|0.69|<0.0001
71812177|NCT05361655|143127122|OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7|||Cox proportional hazards model|||||0.70|0.54|<0.0001
71812178|NCT01984697|143127123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.15|||<|0.001|TWO_SIDED|95.0|1.83|2.53|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.53|1.83|<0.001
71844737|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|0.18|||||TWO_SIDED|95.0|-1.6|1.9||Hypothesis testing not pre-specified.|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72||1.9|-1.6|
71844738|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|-0.12|||||TWO_SIDED|95.0|-1.9|1.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.7|-1.9|
71844739|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|0.75|||||TWO_SIDED|95.0|-1.2|2.7||Hypothesis testing not pre-specified|ANCOVA|Analyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96||2.7|-1.2|
71844740|NCT02307682|143202458|OTHER|Treatment difference|Least squares mean difference|1.05|||||TWO_SIDED|95.0|-0.9|3.0||Hypothesis testing not pre-specified.|ANCOVA|nalyzed using pairwise ANCOVA model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||3.0|-0.9|
71844741|NCT05630833|143202462|OTHER||Lower 10th percentile (%)|48.2|||||||||||||Lower 10th percentile of therapeutic successes was calculated from the predictive distribution.|As defined in Statistical Analysis Plan, consistency with the global studies is demonstrated if the success criterion for gepotidacin is set to require a therapeutic response rate greater than lower 10th percentile value of the predictive distribution.||||
71844742|NCT03905694|143202497|OTHER|Not applied|Least Squares (LS) Mean|-71.97|||||TWO_SIDED|95.0|-77.52|-66.42|||Mixed model for repeated measures (MMRM)|||Mixed-effect Model Repeated Measures (MMRM) includes scheduled visits (months 3, 4, 5, and 6) and baseline spot urinary oxalate:creatine ratio as fixed effects. Autoregressive (1) was used to model the within-patient error.||-66.42|-77.52|
71844743|NCT00945321|143202527|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.93||||0.001|TWO_SIDED|95.0|0.84|1.02||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.02|0.84|0.001
71844744|NCT00945321|143202527|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.96|1.15||Hochberg's step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR\>0.80 and GMR≥1.25 vs. GMR\<1.25).||||1.15|0.96|<0.001
71844745|NCT00945321|143202527|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.47|||||TWO_SIDED|90.0|1.23|1.76||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.76|1.23|
71844746|NCT00945321|143202527|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.08|||||TWO_SIDED|90.0|0.88|1.32||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.32|0.88|
71844747|NCT00945321|143202527|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.22|||||TWO_SIDED|90.0|1.01|1.46||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.46|1.01|
71844748|NCT00945321|143202527|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.43|||||TWO_SIDED|90.0|1.16|1.75||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.75|1.16|
71844749|NCT00945321|143202528|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.56|1.13|
71844750|NCT00945321|143202528|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.04|||||TWO_SIDED|95.0|0.86|1.25||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.25|0.86|
71676876|NCT02120833|142871948|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71844751|NCT00945321|143202528|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.14|||||TWO_SIDED|90.0|0.96|1.34||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.34|0.96|
71844752|NCT00945321|143202528|SUPERIORITY_OR_OTHER||Least-Squares Mean Ratio|1.4|||||TWO_SIDED|90.0|1.16|1.68||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects||1.68|1.16|
71812179|NCT01984697|143127123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.02|||<|0.001|TWO_SIDED|95.0|1.73|2.36|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.36|1.73|<0.001
71812180|NCT01984697|143127123|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.47|||<|0.001|TWO_SIDED|95.0|2.93|4.11|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.11|2.93|<0.001
71812181|NCT01984697|143127124|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.8|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.8|<0.001
71812182|NCT01984697|143127124|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
71812183|NCT01984697|143127124|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
71812184|NCT01984697|143127125|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.39|||<|0.001|TWO_SIDED|95.0|2.03|2.82|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.82|2.03|<0.001
71812185|NCT01984697|143127125|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.09|2.88|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.88|2.09|<0.001
71812186|NCT01984697|143127125|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|5.07|||<|0.001|TWO_SIDED|95.0|4.32|5.94|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.94|4.32|<0.001
71812187|NCT01984697|143127126|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.54|||<|0.001|TWO_SIDED|95.0|2.14|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.14|<0.001
71812188|NCT01984697|143127126|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.69|||<|0.001|TWO_SIDED|95.0|2.29|3.15|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.15|2.29|<0.001
71812189|NCT01984697|143127126|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.54|||<|0.001|TWO_SIDED|95.0|3.84|5.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.37|3.84|<0.001
71812190|NCT01984697|143127127|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.46|||<|0.001|TWO_SIDED|95.0|2.05|2.96|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.96|2.05|<0.001
71812191|NCT01984697|143127127|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.04|2.92|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.92|2.04|<0.001
71812192|NCT01984697|143127127|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.69|||<|0.001|TWO_SIDED|95.0|3.06|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.06|<0.001
71812193|NCT01984697|143127128|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.1|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.00|2.10|<0.001
71812194|NCT01984697|143127128|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.2|3.12|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.12|2.20|<0.001
71812195|NCT01984697|143127128|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.7|||<|0.001|TWO_SIDED|95.0|3.08|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||4.45|3.08|<0.001
71812196|NCT01984697|143127129|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.96|||<|0.001|TWO_SIDED|95.0|2.5|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.50|<0.001
71812197|NCT01984697|143127129|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.99|||<|0.001|TWO_SIDED|95.0|2.55|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.50|2.55|<0.001
71812198|NCT01984697|143127129|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|6.31|||<|0.001|TWO_SIDED|95.0|5.36|7.43|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||7.43|5.36|<0.001
71895884|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.02|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.39|1.02|
71895885|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.38|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.45|1.38|
71895886|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|2.2|||||TWO_SIDED|95.0|1.53|3.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.12|1.53|
71895887|NCT01025336|143313928|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.18|2.82|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS-23vPS/13vPnC)\].|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.82|1.18|
71895888|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.25|1.02|
71895889|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.78|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.44|0.78|
71895890|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.06|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|1.06|
71895891|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.41|1.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.04|0.41|
71895892|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.82|5.24|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.24|1.82|
71895893|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|2.4|||||TWO_SIDED|95.0|1.43|4.11|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||4.11|1.43|
71895894|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.00|0.96|
71895895|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.6|||||TWO_SIDED|95.0|0.88|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||3.04|0.88|
71895896|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.54|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.54|0.64|
71895897|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.71|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.93|0.71|
71895898|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|1.01|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.04|1.01|
71895899|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.84|2.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.06|0.84|
71895900|NCT01025336|143313929|SUPERIORITY_OR_OTHER||Ratio of GMT|3.1|||||TWO_SIDED|95.0|1.89|5.2|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||5.20|1.89|
71895901|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.72|1.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.51|0.72|
71895902|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.52|0.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.94|0.52|
71895903|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.58|1.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.47|0.58|
71895904|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.25|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.59|0.25|
71895905|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.85|2.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.32|0.85|
71895906|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.82|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.13|0.82|
71895907|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.37|0.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.97|0.37|
71895908|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.54|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.70|0.54|
71895909|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.41|0.59|
71844753|NCT00692913|143202533|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.2|||<|0.001||95.0|0.12|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.||||0.35|0.12|<0.001
71844754|NCT00692913|143202534|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-9.7|||<|0.001||95.0|-14.49|-4.93|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.93|-14.49|<0.001
71844755|NCT00692913|143202535|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|-7.07|||<|0.001||95.0|-10.95|-3.2|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.20|-10.95|<0.001
71844756|NCT00692913|143202536|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.21|||<|0.001||95.0|0.13|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||0.35|0.13|<0.001
71844757|NCT00692913|143202537|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.01||||0.047||95.0|0.01|2.0|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.|||2.00|0.01|0.047
71844758|NCT00692913|143202537|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.82||||0.035||95.0|0.06|1.58|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Total Hip.|||1.58|0.06|0.035
71844759|NCT00692913|143202538|SUPERIORITY_OR_OTHER_LEGACY||Difference of falls (falls/patient-year)|0.03|STANDARD_ERROR_OF_MEAN|0.08||0.675||95.0|-0.12|0.19|||Zero-Inflated Poisson Regression|Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).||||0.19|-0.12|0.675
71844760|NCT00692913|143202539|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.35||||0.001||95.0|-13.19|-3.54|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-3.54|-13.19|0.001
71844761|NCT00692913|143202540|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Mean|-8.07|||<|0.001||95.0|-11.94|-4.21|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.||||-4.21|-11.94|<0.001
71844762|NCT02866942|143202553|OTHER|||||||0.26|||||||McNemar|||||||0.26
71844763|NCT02568215|143202592|OTHER||Prevention Efficacy (PE)|8.8||||0.7|TWO_SIDED|95.0|-45.1|42.6||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||42.6|-45.1|0.70
71844764|NCT02568215|143202592|OTHER||Prevention Efficacy (PE)|-9.3|||||TWO_SIDED|95.0|-85.3|35.5||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||35.5|-85.3|
71844765|NCT02568215|143202592|OTHER||Prevention Efficacy (PE)|27.0|||||TWO_SIDED|95.0|-30.7|59.3||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||59.3|-30.7|
71844766|NCT02568215|143202594|OTHER||Prevention Efficacy (PE)|78.6|||||TWO_SIDED|95.0|17.3|94.4||||||PE against IC80 of least sensitive variant less than 1||94.4|17.3|
71844767|NCT02568215|143202594|OTHER||Prevention Efficacy (PE)|7.4|||||TWO_SIDED|95.0|-187.5|70.2||||||PE against IC80 of least sensitive variant 1-3||70.2|-187.5|
71844768|NCT02568215|143202594|OTHER||Prevention Efficacy (PE)|-1.9|||||TWO_SIDED|95.0|-83.1|43.3||||||PE against IC80 of least sensitive variant \> 3||43.3|-83.1|
71844769|NCT00336505|143202596|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|2.0||||0.5667|TWO_SIDED|95.0|-4.8|8.9|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||8.9|-4.8|0.5667
71844770|NCT00336505|143202598|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|0.3|||>|0.9999||95.0|-4.5|5.1|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||5.1|-4.5|>0.9999
71844771|NCT01561300|143202600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.09|TWO_SIDED|95.0|-2.16|0.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.17|-2.16|0.09
71844772|NCT01561300|143202601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.7|TWO_SIDED|95.0|-2.44|1.66|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea- Control|Null hypothesis: no difference between Tea and Control.||1.66|-2.44|0.70
71844773|NCT01561300|143202602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.15|0.75||Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Mixed Models Analysis||Tea-placebo|Null hypothesis: no difference between Tea and Control.||0.75|-1.15|0.66
71844774|NCT00246805|143202607|SUPERIORITY_OR_OTHER||Proportions|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0|||Z-test for proportions|||VRS ON vs. VRS OFF||61|36|<0.0001
71844775|NCT02029235|143202637|OTHER|||||||0.24|||||||t-test, 2 sided|||"Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm."||||0.24
71844776|NCT02029235|143202638|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: No difference between groups||||0.06
71844777|NCT04066075|143202652|SUPERIORITY|||||||0.73||||||The p-value represents the difference between telerehabilitation and usual care.|Multilevel linear regression model|||Multilevel modeling in linear regression analyses accounted for within-patient correlations for the 3 assessments at baseline, 1-month and 4-months. Rasch analysis using the method of successive dichotomizations was applied to estimate person measures. Power calculation: a matched pairs t-test revealed 18 subjects per group would detect a within-subject mean improvement of 0.14-logits with 0.17-logits standard deviation for the differences, 0.80 power and 0.05 type 1 error probability.||||0.73
71844778|NCT03160885|143202677|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|11.1|||<|0.001|TWO_SIDED|95.0|5.8|16.4||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||16.4|5.8|<0.001
71844779|NCT03160885|143202678|SUPERIORITY|Primary endpoints tested sequentially at a 5% significance level.|Risk Difference (RD)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.3||Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.|Cochran-Mantel-Haenszel|Primary endpoints tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.The null hypothesis of no difference in response rates between tralokinumab and placebo were tested against the 2-sided alternative that there is a difference.||27.3|15.8|<0.001
71844780|NCT03160885|143202679|SUPERIORITY||Risk Difference (RD)|15.6|||<|0.001|TWO_SIDED|95.0|10.3|20.9||Based on the primary analysis of the primary estimand 'Composite', subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders'.|Cochran-Mantel-Haenszel|Tested sequentially at a 5% significance level.|Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|Reduction of Worst Daily Pruritus NRS weekly average ≥4 at Week 16 was tested after the sequential testing of IGA 0/1 and EASI75 if these tests showed statistical significance||20.9|10.3|<0.001
71844781|NCT03160885|143202680|SUPERIORITY|Multiplicity adjustment using the Holm method.|Difference of least square means|-14.0|||<|0.001|TWO_SIDED|95.0|-18.0|-10.1||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-10.1|-18.0|<0.001
71844782|NCT03160885|143202681|SUPERIORITY|Multiplicity adjustment using Holm method.|Difference of least square means|-3.9|||<|0.001|TWO_SIDED|95.0|-5.2|-2.6||Based on the primary analysis of the primary estimand 'hypothetical'. Repeated measurements model on post-baseline data. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change was imputed as 0.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included.||-2.6|-5.2|<0.001
71895910|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.17|0.48|
71895911|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.58|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||1.05|0.58|
71895912|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|0.6|||||TWO_SIDED|95.0|0.41|0.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||0.88|0.41|
71895913|NCT01025336|143313930|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.05|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 13vPnC/23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.||2.81|1.05|
71895914|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.27|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|1.27|
71812199|NCT01984697|143127130|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.67|||<|0.001|TWO_SIDED|95.0|1.38|2.03|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.03|1.38|<0.001
71844783|NCT03160885|143202682|SUPERIORITY||Risk Difference (RD)|34.1||||0.004|TWO_SIDED|95.0|13.4|54.9||Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||54.9|13.4|0.004
71844784|NCT03160885|143202682|SUPERIORITY||Risk Difference (RD)|19.9||||0.084|TWO_SIDED|95.0|-1.2|40.9||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.~P value was considered non-significant"|Cochran-Mantel-Haenszel|This test was not statistically significant and hence next maintenance endpoint in the sequential testing procedure was not evaluated|Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||40.9|-1.2|0.084
71844785|NCT03160885|143202683|SUPERIORITY||Risk Difference (RD)|33.7|||<|0.001|TWO_SIDED|95.0|17.3|50.0||Based on the primary analysis of the primary estimand 'composite'. Subjects who received rescue medication or were transferred to open-label treatment are considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||50.0|17.3|<0.001
71844786|NCT03160885|143202683|SUPERIORITY||Risk Difference (RD)|30.0||||0.001|TWO_SIDED|95.0|13.7|46.4||Test not evaluated for statistical significance. Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication or were transferred to open-label treatment were considered non-responders.|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference compared to placebo, stratified by region.|"Testing according to the hierarchical testing procedure in the order:~IGA 0/1 at Week 52 between Q2W vs Placebo, EASI75 at Week 52 between Q2W vs Placebo, IGA 0/1 at Week 52 between Q4W vs Placebo, and EASI75 at Week 52 between Q4W vs Placebo"||46.4|13.7|0.001
71676877|NCT02120833|142871948|SUPERIORITY_OR_OTHER|||||||0.2447|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2447
71812200|NCT01984697|143127130|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.37|1.99|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.99|1.37|<0.001
71812201|NCT01984697|143127130|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.61|2.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.37|1.61|<0.001
71812202|NCT01984697|143127131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.36|1.87|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||1.87|1.36|<0.001
71812203|NCT01984697|143127131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.51|2.05|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||2.05|1.51|<0.001
71812204|NCT01984697|143127131|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|3.08|||<|0.001|TWO_SIDED|95.0|2.64|3.61|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.61|2.64|<0.001
71812205|NCT01984697|143127132|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT ratio|2.55|||<|0.001|TWO_SIDED|95.0|2.15|3.01|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.01|2.15|<0.001
71812206|NCT01984697|143127132|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|2.7|||<|0.001|TWO_SIDED|95.0|2.3|3.16|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||3.16|2.30|<0.001
71812207|NCT01984697|143127132|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is \>0.67.|GMT Ratio|4.98|||<|0.001|TWO_SIDED|95.0|4.23|5.86|||ANOVA|One-sided non-inferiority test at alpha=0.025 level||||5.86|4.23|<0.001
71812208|NCT01984697|143127133|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
71895915|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.95|1.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.59|0.95|
71844787|NCT03160885|143202686|SUPERIORITY||Risk Difference (RD)|29.3|||<|0.001|TWO_SIDED|95.0|22.5|36.1||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||36.1|22.5|<0.001
71844788|NCT03160885|143202687|SUPERIORITY||Risk Difference (RD)|12.7|||<|0.001|TWO_SIDED|95.0|8.3|17.0||"Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data or subjects who received rescue medication prior to Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and disease severity.|||17.0|8.3|<0.001
71844789|NCT03160885|143202688|SUPERIORITY||Difference of least square means|-9.9|||<|0.001|TWO_SIDED|95.0|-12.2|-7.5||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 2 change will be imputed as 0.||-7.5|-12.2|<0.001
71844790|NCT03160885|143202689|SUPERIORITY||Risk Difference (RD)|8.0|||<|0.001|TWO_SIDED|95.0|4.4|11.6||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||11.6|4.4|<0.001
71844791|NCT03160885|143202690|SUPERIORITY||Risk Difference (RD)|18.9|||<|0.001|TWO_SIDED|95.0|12.8|25.1||"Based on the primary analysis of the 'composite' estimand. Subjects who received rescue medication prior to Week 16 or with missing data at Week 16 were considered non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference stratified by region and disease severity.|||25.1|12.8|<0.001
71844792|NCT03160885|143202691|SUPERIORITY||Difference of least square means|-1.3|||<|0.001|TWO_SIDED|95.0|-1.7|-0.8||The statistical test was not controlled for multiplicity.|Repeated measurements model|||Data collected after permanent discontinuation of IMP or initiation of rescue medication not included. In case of no post-baseline assessments before initiation of rescue medication, the Week 1 change will be imputed as 0.||-0.8|-1.7|<0.001
71844793|NCT03160885|143202692|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.001|TWO_SIDED|95.0|13.9|26.2||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||26.2|13.9|<0.001
71844794|NCT03160885|143202693|SUPERIORITY||Risk Difference (RD)|28.9|||<|0.001|TWO_SIDED|95.0|21.4|36.3||"Subjects who received rescue medication prior to Week 16 or have missing data at Week 16 were considered as non-responders.~The statistical test was not controlled for multiplicity."|Cochran-Mantel-Haenszel||Mantel-Haenszel risk difference, stratified by region and baseline disease severity.|||36.3|21.4|<0.001
71844795|NCT05890794|143202696|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|40.85||||0.0005|TWO_SIDED|95.0|22.842|58.858||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PPi.||58.858|22.842|0.0005
71844796|NCT05890794|143202696|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error|Difference in LS Means|-11.17|STANDARD_ERROR_OF_MEAN|2.681|<|0.0001|TWO_SIDED|95.0|-16.52|-5.82||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by a mixed model repeated measures (MMRM) analysis for PPi.||-5.82|-16.52|<0.0001
71844797|NCT05890794|143202697|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|30.89|||<|0.0001|TWO_SIDED|95.0|20.831|40.941||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PLP.||40.941|20.831|<0.0001
71895916|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.29|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.29|1.03|
71895917|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.95|1.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.97|0.95|
71812209|NCT01984697|143127133|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.0|<0.001
71812210|NCT01984697|143127133|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.3|-1.1|<0.001
71812211|NCT01984697|143127134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
71812212|NCT01984697|143127134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
71895918|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|2.2|||||TWO_SIDED|95.0|1.42|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.31|1.42|
71895919|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.88|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.04|0.88|
71895920|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.95|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.40|0.95|
71895921|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.7|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.99|0.70|
71895922|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.25|0.57|
71895923|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.06|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.12|1.06|
71676878|NCT02120833|142871948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|0.67||0.0216|TWO_SIDED|95.0|-2.95|-0.25||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.25|-2.95|0.0216
71812213|NCT01984697|143127134|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.2|-1.0|<0.001
71895924|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.97|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||1.69|0.97|
71895925|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|1.8|||||TWO_SIDED|95.0|1.21|2.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||2.53|1.21|
71895926|NCT01025336|143313931|SUPERIORITY_OR_OTHER||Ratio of GMT|2.3|||||TWO_SIDED|95.0|1.54|3.42|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/13vPnC - 23vPS/13vPnC)\]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale||3.42|1.54|
71676879|NCT02120833|142871949|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71844798|NCT05890794|143202697|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-22.51|STANDARD_ERROR_OF_MEAN|6.289||0.0024|TWO_SIDED|95.0|-35.81|-9.2||Significant test: two-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PLP.||-9.20|-35.81|0.0024
71844799|NCT05890794|143202698|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-4335.66||||0.0019|TWO_SIDED|95.0|-6652.753|-2018.576||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for ALP activity.||-2018.576|-6652.753|0.0019
71844800|NCT05890794|143202699|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|23.25||||0.0693|TWO_SIDED|95.0|-2.319|48.812||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for urine PEA.||48.812|-2.319|0.0693
71844801|NCT05890794|143202699|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-8.76|STANDARD_ERROR_OF_MEAN|22.986||0.7086|TWO_SIDED|95.0|-57.88|40.35||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for urine PEA.||40.35|-57.88|0.7086
71844802|NCT05890794|143202700|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|187.43||||0.0199|TWO_SIDED|95.0|36.516|338.344||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in relative maximum change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL.||338.344|36.516|0.0199
71844803|NCT05890794|143202700|OTHER|The difference between LS Means of change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|-12.51|STANDARD_ERROR_OF_MEAN|9.767||0.2034|TWO_SIDED|95.0|-31.92|6.89||Significant test: 2-sided; significance level 5%|Mixed Models Analysis|||Analysis of the difference in relative maximum change from baseline (LS Means) between dose groups of ilofotase alfa by an MMRM analysis for PL.||6.89|-31.92|0.2034
71844804|NCT05890794|143202701|OTHER|The difference in dose group means (0.8 mg/kg - 3.2 mg/kg) was calculated.|Mean Difference (Final Values)|-0.89||||0.5195|TWO_SIDED|95.0|-3.868|2.084||Significant test: 2-sided; significance level 5%.|t-test, 2 sided|A 2-sided t-test was carried out to determine whether there is a difference in means between the 0.8 mg/kg and 3.2 mg/kg dose groups.||Analysis of the difference in fold change from baseline between dose groups of ilofotase alfa by a 2-sided t-test for PL/PLP ratio.||2.084|-3.868|0.5195
71844805|NCT05890794|143202701|OTHER|The difference between LS Means of fold change from baseline between dose groups was calculated. The analysis was performed using an MMRM model with fixed effects for baseline value, dose group, timepoint, interaction between dose group and timepoint, as well as random effects for patient and error.|Difference in LS Means|1.01|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|0.69|1.33||Significant test: 2-sided; significance level 5%.|Mixed Models Analysis|||Analysis of the difference in fold change form baseline (LS Means) between dose levels of ilofotase alfa by an MMRM analysis for PL/PLP ratio.||1.33|0.69|<0.0001
71844806|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence|Slope|0.0||||0.74|TWO_SIDED|95.0|-0.1|0.2||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Age covariate effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.2|-0.1|0.74
71844807|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence|Slope|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3||P value: For the categorical variable with more than 2 levels, this is the p value from the overall test of the null hypothesis that all estimates are equal against the alternative that at least one is different.|Regression, Linear|||"Baseline COST effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||-0.3|-0.6|<0.001
71844808|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence||||||0.002||||||This is the p value of the null hypothesis that COST estimates for all cancer types (Colon cancer, Rectal cancer and Rectosigmoid) are equal against the alternative that at least one is different.|Regression, Linear|||"Cancer type (Colon cancer, Rectal cancer and Rectosigmoid) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.002
71895927|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.8|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.63|0.80|
71895928|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.77|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.39|0.77|
71895929|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.69|0.68|
71895930|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.03|2.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.31|1.03|
71844809|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence|Slope|0.3||||0.03|TWO_SIDED|95.0|0.0|0.6|||Regression, Linear|||"FACT-G7 effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||0.6|0.0|0.03
71844810|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence|Slope|1.6||||0.13|TWO_SIDED|95.0|-0.5|3.7|||Regression, Linear|||"Gender effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||3.7|-0.5|0.13
71844811|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence||||||0.91||||||This is the p value of the null hypothesis that COST estimates for all RACES (White, Black, other) are equal against the alternative that at least one is different.|Regression, Linear|||"RACE (White. Black Other) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Null: All estimates are equal"||||0.91
71844812|NCT03516942|143202768|EQUIVALENCE|No margin of equivalence|Slope|0.0|||>|0.99|TWO_SIDED|95.0|-0.3|0.3|||Regression, Linear|||"Neighborhood Deprivation (NDI) effect on change in COST The linear (non-longitudinal) model of \[change in COST from baseline to 12-month follow-up\] included covariates for: age, Baseline COST score, cancer stage, cancer type, chemotherapy, comorbidities, education, FACT-G7, gender, income, marital status, insurance status, race, safety-net hospital, self-efficacy, NDI.~Higher NDI = greater neighborhood deprivation"||0.3|-0.3|>0.99
71844813|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.4142||||||alpha=0.05|McNemar|||Work Time Missed from Baseline to 6 Months||||0.4142
71844814|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.1797|||||||McNemar|||Impairment of Activities at Work from Baseline to 6 Months||||0.1797
71844815|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.8415|||||||McNemar|||Overall Work Impairment from Baseline to 6 Months||||0.8415
71844816|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.6831|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 6 Months||||0.6831
71844817|NCT03516942|143202770|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Work Time Missed from Baseline to 12 Months||||<.0001
71844818|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.0455|||||||McNemar|||Impairment of Activities at Work from Baseline to 12 Months||||0.0455
71676880|NCT02120833|142871949|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0476
71844819|NCT03516942|143202770|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 12 Months||||<.0001
71895931|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|2.7|||||TWO_SIDED|95.0|1.66|4.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||4.55|1.66|
71895932|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|3.7|||||TWO_SIDED|95.0|2.25|5.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.94|2.25|
71844820|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.0164|||||||McNemar|||3 Impairment of Activities Outside of Work from Baseline to 12 Months||||0.0164
71844821|NCT03516942|143202770|EQUIVALENCE|nomargin||||||0.0027|||||||McNemar|||Work Time Missed from Baseline to 24 Months||||0.0027
71844822|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.0124|||||||McNemar|||Impairment of Activities at Work from Baseline to 24 Months||||0.0124
71844823|NCT03516942|143202770|EQUIVALENCE|no margin|||||<|0.0001|||||||McNemar|||Overall Work Impairment from Baseline to 24 Months||||<.0001
71844824|NCT03516942|143202770|EQUIVALENCE|no margin||||||0.0011|||||||McNemar|||Impairment of Activities Outside of Work from Baseline to 24 Months||||0.0011
71812214|NCT01984697|143127135|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
71812215|NCT01984697|143127135|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
71844825|NCT03516942|143202776|EQUIVALENCE|no equivalence margin was assumed||||||0.017|||||||McNemar|||the McNemar test was used to compare the results assuming a null of no difference.||||0.017
71844826|NCT04551066|143202777|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2019|TWO_SIDED|95.0|0.81|2.65||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||2.65|0.81|0.2019
71844827|NCT04551066|143202778|SUPERIORITY||Odds Ratio (OR)|0.83||||0.5356|TWO_SIDED|95.0|0.46|1.5||calculated from Cochran Mantel-Haenszel test stratified by Baseline platelet count ≥100 x 10\^9/Liters versus 50 to \<100 x 10\^9/Liters inclusive|Cochran-Mantel-Haenszel|||||1.50|0.46|0.5356
71844828|NCT04551066|143202780|SUPERIORITY|||||||0.9354||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.9354
71844829|NCT04551066|143202784|SUPERIORITY|||||||0.0945||||||calculated from log-rank test stratified by Baseline platelet count ≥100 × 10\^9/Liters versus 50 to \<100 × 10\^9/Liters inclusive|Log Rank|||||||0.0945
71895933|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|6.2|||||TWO_SIDED|95.0|3.85|9.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||9.98|3.85|
71895934|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|2.43|7.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||7.40|2.43|
71895935|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.89|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.13|0.89|
71895936|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.06|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.57|1.06|
71895937|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|2.0|||||TWO_SIDED|95.0|1.5|2.78|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.78|1.50|
71812216|NCT01984697|143127135|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.5|||<|0.001|TWO_SIDED|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||3.8|0.1|<0.001
71844830|NCT03301467|143202809|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.967|TWO_SIDED|95.0|-1.9|1.8|||ANCOVA|||||1.8|-1.9|0.9670
71895938|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|3.4|||||TWO_SIDED|95.0|2.3|5.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||5.04|2.30|
71895939|NCT01025336|143313932|SUPERIORITY_OR_OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.37|3.37|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(13vPnC/23vPS - 23vPS)\]|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.37|1.37|
71895940|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 1: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.90|0.48|
71844831|NCT03301467|143202810|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.3083|TWO_SIDED||||||Van Elteren's Test||"Test for normality showed that mean change and mean percent change were not normally distributed. As per SAP, Van Elteren's test was then applied to test mean percent change.~SAP=Statistical Analysis Protocol"|||||0.3083
71844832|NCT03301467|143202811|SUPERIORITY|||||||0.4591|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.4591
71844833|NCT03301467|143202812|SUPERIORITY|||||||0.3106|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi square general association statistic||||||0.3106
71812217|NCT01984697|143127136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.8|-1.7|<0.001
71844834|NCT03301467|143202813|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.3368|TWO_SIDED|95.0|-1.5|0.5|||ANCOVA|||||0.5|-1.5|0.3368
71812218|NCT01984697|143127136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
71812219|NCT01984697|143127136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
71812220|NCT01984697|143127137|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
71812221|NCT01984697|143127137|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.0|<0.001
71812222|NCT01984697|143127137|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.0|-1.1|<0.001
71812223|NCT01984697|143127138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
71812224|NCT01984697|143127138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|1.4|||<|0.001|TWO_SIDED|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.0|-0.7|<0.001
71844835|NCT03301467|143202814|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0401|TWO_SIDED|95.0|-1.7|0.0|||ANCOVA|||||-0.0|-1.7|0.0401
71895941|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.64|1.09|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 3: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.09|0.64|
71812225|NCT01984697|143127138|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|2.1|||<|0.001|TWO_SIDED|95.0|0.7|4.6|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||4.6|0.7|<0.001
71812226|NCT01984697|143127139|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.0|||<|0.001|TWO_SIDED|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||1.7|-1.7|<0.001
71812227|NCT01984697|143127139|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
71812228|NCT01984697|143127139|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
71844836|NCT03301467|143202815|SUPERIORITY||Mean Difference (Final Values)|10.84||||0.0534|TWO_SIDED|95.0|-0.16|21.85|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||21.85|-0.16|0.0534
71676881|NCT02120833|142871949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.78||0.2349|TWO_SIDED|95.0|-2.52|0.64||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.64|-2.52|0.2349
71844837|NCT03301467|143202816|SUPERIORITY||Mean Difference (Final Values)|10.67||||0.0221|TWO_SIDED|95.0|1.56|19.78|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||19.78|1.56|0.0221
71844838|NCT03301467|143202817|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.2638|TWO_SIDED|95.0|-3.08|11.08|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||11.08|-3.08|0.2638
71676882|NCT02120833|142871950|SUPERIORITY_OR_OTHER|||||||0.7842|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.7842
71812229|NCT01984697|143127140|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
71812230|NCT01984697|143127140|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.0|<0.001
71812231|NCT01984697|143127140|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is \> -5.|Seroconversion percentage difference|0.4|||<|0.001|TWO_SIDED|95.0|-1.1|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level||||2.1|-1.1|<0.001
71812232|NCT03091673|143127201|OTHER||||||<|0.001||||||P-value was computed using a t-test to determine if change in plasma glucose from baseline to 30 minutes was zero.|t-test, 2 sided|||||||<0.001
71812233|NCT00605202|143127219|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value of the change in the plasma potassium (baseline to 2 weeks) between arms|t-test, 2 sided|||Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms||||0.007
71812234|NCT02276066|143127235|OTHER|We performed a delta analysis, by graphing the difference between the two measurements, we wanted to visually assess the degree of agreement or discrepancy between the two methods. We were looking to evaluate the consistency, accuracy, or bias between different measurement techniques.|||||<|0.05|||||||Delta analysis|||||||<0.05
71812235|NCT05050578|143127241|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.003|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, visit, lens by visit interaction, period, sequence) and random (subject) effects. Difference = LID18869 minus AOHG. Sign is retained with the rounded value.|||0.00||
71812236|NCT03386032|143127251|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means.||Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.||||<0.05
71812237|NCT03386032|143127252|SUPERIORITY||||||<|0.05|||||||ANCOVA|Model adjusted means. Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left miss||"Change from baseline in variables were analyzed separately using a mixed model for repeated measures with Subject nested within treatment (random effect), and Treatment, Week, Treatment-by-Week, Age \& Baseline (fixed effects). Last Observation was Carried Forward (LOCF) for drops. Sporadic missing data were left missing.~Significance level: 0.05 (2-sided)"||||<0.05
71812238|NCT02943941|143127272|OTHER|||||||0.429|||||||ANOVA|||||||0.429
71812239|NCT02943941|143127273|OTHER|||||||0.059||||||Pressure during coughing versus normal breathing initially measured at baseline.|ANOVA|||||||0.059
71812240|NCT02943941|143127274|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71812241|NCT02901626|143127275|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.83|1.2||||||||1.20|0.83|
71812242|NCT02901626|143127276|SUPERIORITY||Median Difference (Net)|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||||8|-4|
71812243|NCT02901626|143127277|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.06|0.8||||||||0.80|-1.06|
71812244|NCT02901626|143127278|SUPERIORITY||Risk Ratio (RR)|1.26|||||TWO_SIDED|95.0|0.92|1.71||||||||1.71|0.92|
71676883|NCT02120833|142871950|SUPERIORITY_OR_OTHER|||||||0.6083|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.6083
71812245|NCT02901626|143127279|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.93|1.55||||||||1.55|0.93|
71812246|NCT02901626|143127280|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.93|1.45||||||||1.45|0.93|
71812247|NCT02901626|143127281|SUPERIORITY||Risk Ratio (RR)|1.3|||||TWO_SIDED|95.0|0.92|1.82||||||||1.82|0.92|
71812248|NCT02901626|143127282|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.79|1.19||||||||1.19|0.79|
71812249|NCT02901626|143127283|SUPERIORITY||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.61|2.39||||||||2.39|0.61|
71812250|NCT02901626|143127284|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.79|1.31||||||||1.31|0.79|
71812251|NCT02901626|143127285|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.55|2.04||||||||2.04|0.55|
71812252|NCT02901626|143127286|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
71812253|NCT02901626|143127287|SUPERIORITY||Risk Ratio (RR)|1.36|||||TWO_SIDED|95.0|0.95|1.94||||||||1.94|0.95|
71812254|NCT02901626|143127288|SUPERIORITY||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|1.0|2.11||||||||2.11|1.00|
71812255|NCT02901626|143127289|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.88|1.18||||||||1.18|0.88|
71812256|NCT02901626|143127290|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|-12.0|12.0||||||||12|-12|
71812257|NCT02901626|143127291|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
71812258|NCT02901626|143127292|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-12.0|14.0||||||||14|-12|
71812259|NCT02901626|143127293|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.06|15.7||||||||15.7|0.06|
71812260|NCT02901626|143127294|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.25|2.65||||||||2.65|0.25|
71812261|NCT02901626|143127295|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.17|1.9||||||||1.90|0.17|
71812262|NCT02901626|143127296|SUPERIORITY||Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.68|1.96||||||||1.96|0.68|
71895942|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.3|||||TWO_SIDED|95.0|0.2|0.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 4: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.44|0.20|
71895943|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.59|1.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 5: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.26|0.59|
71895944|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.11|0.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.26|0.11|
71812263|NCT02901626|143127297|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.71|1.27||||||||1.27|0.71|
71812264|NCT02901626|143127298|SUPERIORITY||Risk Ratio (RR)|0.72|||||TWO_SIDED|95.0|0.37|1.41||||||||1.41|0.37|
71812265|NCT02901626|143127299|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.39|3.37||||||||3.37|0.39|
71812266|NCT02901626|143127300|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.78|1.29||||||||1.29|0.78|
71812267|NCT02901626|143127301|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.58|1.1||||||||1.10|0.58|
71812268|NCT02901626|143127302|SUPERIORITY||Risk Ratio (RR)|2.45|||||TWO_SIDED|95.0|0.48|12.57||||||||12.57|0.48|
71812269|NCT02901626|143127303|SUPERIORITY||Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.27|1.58||||||||1.58|0.27|
71812270|NCT02901626|143127304|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.47|0.97||||||||0.97|0.47|
71812271|NCT02901626|143127305|SUPERIORITY||Risk Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.09|2.66||||||||2.66|0.09|
71812272|NCT02901626|143127306|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.81|1.37||||||||1.37|0.81|
71812273|NCT02901626|143127307|SUPERIORITY||Median Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0|0|
71812274|NCT02901626|143127308|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|-16.0|36.0||||||||36|-16|
71812275|NCT00331344|143127311|OTHER||Dose Level VIa|1.0|||||TWO_SIDED||||||||Dose level VIa (mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes, ixabepilone 30mg/m2 IV over 3 hours on day 1, pegfilgrastim 6mg SC on day 2, oral prednisone twice daily on days 1-21) was determined to be MTD, based on 1 event of DLT at VIa.|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the MTD. If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m\^2.||||
71895945|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.49|1.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 6B: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.22|0.49|
71895946|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.68|1.76|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 7F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.76|0.68|
71812276|NCT02940574|143127329|OTHER|Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|||||<|0.08||||||Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of 'treatment' (F(1,36)=2.00; p=.08 (one-sided))|Mixed Models Analysis|(F(1,36)=2.00; p=.08 (one-sided))||||||<0.08
71812277|NCT03525548|143127352|SUPERIORITY||Least squares (LS) mean difference|10.0|||<|0.0001|TWO_SIDED|95.0|7.4|12.6|||Mixed-effects model for repeated measure|||||12.6|7.4|<0.0001
71812278|NCT03525548|143127353|SUPERIORITY||LS mean difference|-45.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-40.1|||Mixed-effects model for repeated measure|||||-40.1|-50.1|<0.0001
71812279|NCT03525548|143127354|SUPERIORITY||LS mean difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.8|23.0|||Mixed-effects model for repeated measure|||||23.0|11.8|<0.0001
71812280|NCT02623855|143127364|SUPERIORITY|Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.||||||0.6099|||||||t-test, 2 sided|||The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.||||0.6099
71812281|NCT02623855|143127366|SUPERIORITY|||||||0.0085|||||||t-test, 2 sided|||||||0.0085
71812282|NCT02623855|143127368|SUPERIORITY|||||||0.1749|||||||t-test, 2 sided|||||||0.1749
71812283|NCT01059630|143127373|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.7|||Log Rank|||||0.70|0.40|<0.0001
71812284|NCT01059630|143127375|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.45|0.73|||Log Rank|||||0.73|0.45|<0.0001
71812285|NCT01059630|143127376|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|0.98||||0.9298|TWO_SIDED|95.0|0.58|1.65|||Cochran-Mantel-Haenszel|||||1.65|0.58|0.9298
71812286|NCT01059630|143127377|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|-0.9||||0.7857|TWO_SIDED|95.0|-8.44|6.64|||Cochran-Mantel-Haenszel|||||6.64|-8.44|0.7857
71812287|NCT01059630|143127382|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|2.24||||0.8347|TWO_SIDED|95.0|-7.2|11.69|||Cochran-Mantel-Haenszel|||||11.69|-7.20|0.8347
71812288|NCT01059630|143127383|SUPERIORITY_OR_OTHER_LEGACY||Difference in response rate|8.55||||0.0466|TWO_SIDED|95.0|-0.22|17.32|||Cochran-Mantel-Haenszel|||||17.32|-0.22|0.0466
71812289|NCT01059630|143127384|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43|||||TWO_SIDED|95.0|0.31|0.61||||||||0.61|0.31|
71812290|NCT01059630|143127385|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.67||||||||0.67|0.39|
71812291|NCT01059630|143127386|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.04|0.45||||||||0.45|0.04|
71812292|NCT01059630|143127387|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.29|0.81||||||||0.81|0.29|
71812293|NCT01059630|143127388|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.0001|TWO_SIDED|95.0|0.44|0.74|||Log Rank|||||0.74|0.44|0.0001
71812294|NCT01059630|143127390|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.081|TWO_SIDED|95.0|0.57|1.03|||Log Rank|||||1.03|0.57|0.0810
71812295|NCT03170375|143127405|SUPERIORITY|||||||0.28|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.28
71812296|NCT03170375|143127406|SUPERIORITY|||||||0.6|||||||Regression, Linear|adjusted for baseline left ventricular mass index||||||0.60
71812297|NCT03170375|143127407|SUPERIORITY|||||||0.27|||||||Regression, Linear|adjusted for baseline global left ventricular longitudinal strain||||||0.27
71844839|NCT03301467|143202818|SUPERIORITY||Mean Difference (Final Values)|3.82||||0.2069|TWO_SIDED|95.0|-2.14|9.77|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||||9.77|-2.14|0.2069
71844840|NCT03301467|143202819|SUPERIORITY||LSM UPCR Ratio|0.98||||0.9284|TWO_SIDED|95.0|0.67|1.45|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.45|0.67|0.9284
71844841|NCT03301467|143202820|SUPERIORITY||LSM UPCR Ratio|0.86||||0.3778|TWO_SIDED|95.0|0.6|1.21|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM UPCR Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.21|0.60|0.3778
71844842|NCT03301467|143202821|SUPERIORITY||LSM MCP-1 Ratio|0.76||||0.081|TWO_SIDED|95.0|0.55|1.04|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.04|0.55|0.0810
71844843|NCT03301467|143202822|SUPERIORITY||LSM MCP-1 Ratio|0.87||||0.3233|TWO_SIDED|95.0|0.66|1.15|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.|LSM MCP-1 Ratio Week 26 vs Baseline, Avacopan:Placebo|||1.15|0.66|0.3233
71895947|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|0.9|2.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 9V: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.55|0.90|
71895948|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|1.5|||||TWO_SIDED|95.0|1.02|2.3|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 14: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.30|1.02|
71812298|NCT03170375|143127408|SUPERIORITY|||||||0.03|||||||Regression, Linear|adjusted for baseline carotid-femoral pulse wave velocity||||||0.03
71895949|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.52|1.14|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 18C: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.14|0.52|
71812299|NCT03170375|143127412|SUPERIORITY|||||||0.47|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.47
71812300|NCT03170375|143127413|SUPERIORITY|||||||0.28|||||||generalized estimating equation|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.28
71812301|NCT03170375|143127414|SUPERIORITY|||||||0.43|||||||generalized estimating equations|Model includes time (baseline, phase 2 month 1, phase 2 month 6), randomization assignment, and time x randomization assignment||||||0.43
71812302|NCT03170375|143127415|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||||||0.94
71812303|NCT03170375|143127416|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
71812304|NCT00530062|143127420|OTHER||Difference in adjusted mean|0.946||||0.5595|TWO_SIDED|95.0|-2.293|4.185||Threshold for significance at 0.05 level.|ANCOVA|||The analysis was performed using the mixed-effect analysis of variance with fixed effects of center, sequence, treatment group and period, and random effect of the participant within sequence.||4.185|-2.293|0.5595
71812305|NCT01376323|143127436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.13|0.6||||||||0.60|-0.13|
71812306|NCT01376323|143127436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.37|0.35||||||||0.35|-0.37|
71812307|NCT01376323|143127436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13|||||TWO_SIDED|95.0|-0.49|0.23||||||||0.23|-0.49|
71812308|NCT01376323|143127436|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.66|0.06||||||||0.06|-0.66|
71812309|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.551|||||TWO_SIDED|95.0|-1.645|0.543|||||Comparison for glucose.|||0.543|-1.645|
71812310|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.382|||||TWO_SIDED|95.0|-1.472|0.708|||||Comparison for glucose.|||0.708|-1.472|
71812311|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|||||TWO_SIDED|95.0|-1.696|0.516|||||Comparison for glucose.|||0.516|-1.696|
71812312|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.595|||||TWO_SIDED|95.0|-1.669|0.48|||||Comparison for glucose.|||0.480|-1.669|
71812313|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.036|||||TWO_SIDED|95.0|-0.042|0.113|||||Comparison for NEFA.|||0.113|-0.042|
71844844|NCT03301467|143202823|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6025|TWO_SIDED|95.0|-4.6|7.9|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||7.9|-4.6|0.6025
71844845|NCT03301467|143202823|SUPERIORITY||Mean Difference (Final Values)|-0.0422||||0.1797|TWO_SIDED|95.0|-0.1043|0.0198|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0198|-0.1043|0.1797
71844846|NCT03301467|143202824|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.4898|TWO_SIDED|95.0|-7.9|3.8|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L VAS Score||3.8|-7.9|0.4898
71844847|NCT03301467|143202824|SUPERIORITY||Mean Difference (Final Values)|-0.0199||||0.4826|TWO_SIDED|95.0|-0.0757|0.036|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||EQ-5D-5L Index Score||0.0360|-0.0757|0.4826
71844848|NCT03301467|143202825|SUPERIORITY||Mean Difference (Final Values)|0.4019||||0.8161|TWO_SIDED|95.0|-3.0402|3.844|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.8440|-3.0402|0.8161
71844849|NCT03301467|143202825|SUPERIORITY||Mean Difference (Final Values)|0.0052||||0.9982|TWO_SIDED|95.0|-4.5994|4.6099|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||4.6099|-4.5994|0.9982
71844850|NCT03301467|143202826|SUPERIORITY||Mean Difference (Final Values)|-0.1518||||0.9242|TWO_SIDED|95.0|-3.3192|3.0156|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Physical Component Score||3.0156|-3.3192|0.9242
71895950|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.62|1.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.08|0.62|
71895951|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.89|1.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 19F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.98|0.89|
71844851|NCT03301467|143202826|SUPERIORITY||Mean Difference (Final Values)|1.0283||||0.6534|TWO_SIDED|95.0|-3.4972|5.5537|||Mixed Models Analysis|Mixed model repeated measures models with treatment group, visit, and treatment-by-visit interaction as factors and baseline as a covariate.||SF-36v2: Mental Component Score||5.5537|-3.4972|0.6534
71844852|NCT02798471|143202829|NON_INFERIORITY|The edoxaban-to-comparator hazard ratio will be computed with 95% confidence interval (CI) (two-sided) based on this model. Edoxaban will be considered non-inferior to comparator if the upper limit of the 95% CI is ≤1.5.|Hazard Ratio (HR)|1.01||||0.9694|TWO_SIDED|95.0|0.594|1.719|||Regression, Cox|||Statistical analysis for the composite primary efficacy endpoint||1.719|0.594|0.9694
71844853|NCT05293717|143202844|OTHER|This is an open-label study. No power calculation was performed.|||||<|0.001|||||||ANOVA|||||||<0.001
71844854|NCT00712179|143202845|SUPERIORITY_OR_OTHER|||||||0.981|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.||||0.981
71844855|NCT00712179|143202845|SUPERIORITY_OR_OTHER|||||||0.84|||||||Mixed Models Analysis|||Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG pattern||||0.84
71844856|NCT00712179|143202845|SUPERIORITY_OR_OTHER|||||||0.16|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.||||0.16
71844857|NCT00712179|143202845|SUPERIORITY_OR_OTHER|||||||0.073|||||||Mixed Models Analysis|||Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.||||0.073
71844858|NCT00712179|143202845|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.||||<0.001
71844859|NCT00712179|143202845|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.||||0.94
71844860|NCT00065182|143202854|SUPERIORITY||Hazard Ratio (HR)|1.007||||0.946|TWO_SIDED|95.0|0.813|1.248|||Log Rank||Unadjusted hazard ratio.|||1.248|0.813|0.9460
71844861|NCT00065182|143202854|SUPERIORITY||Hazard Ratio (HR)|0.977|||||TWO_SIDED|95.0|0.788|1.21|||||Adjusted hazard ratio.|||1.210|0.788|
71844862|NCT03801148|143202880|EQUIVALENCE|Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|0.98|||||TWO_SIDED|90.0|0.9171|1.0473||||||||1.0473|0.9171|
71844863|NCT03801148|143202880|EQUIVALENCE|ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|1.0737|||||TWO_SIDED|90.0|1.0025|1.1501||||||||1.1501|1.0025|
71844864|NCT03801148|143202881|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.0455|||||TWO_SIDED|90.0|1.007|1.0855||||||||1.0855|1.0070|
71812314|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.004|||||TWO_SIDED|95.0|-0.073|0.081|||||Comparison for NEFA.|||0.081|-0.073|
71812315|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|||||TWO_SIDED|95.0|-0.058|0.099|||||Comparison for NEFA.|||0.099|-0.058|
71844865|NCT03801148|143202881|EQUIVALENCE|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.061|||||TWO_SIDED|90.0|1.0192|1.1046||||||||1.1046|1.0192|
71844866|NCT03801148|143202882|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|Geometric LSM ratio|1.0553|||||TWO_SIDED|90.0|1.0186|1.0933||||||||1.0933|1.0186|
71844867|NCT03801148|143202882|EQUIVALENCE|ln-transformed- AUC0\_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infobs.|GMR|1.0468|||||TWO_SIDED|90.0|1.0027|1.0929||||||||1.0929|1.0027|
71844868|NCT03801148|143202883|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0555|||||TWO_SIDED|90.0|1.0188|1.0935||||||||1.0935|1.0188|
71844869|NCT03801148|143202883|EQUIVALENCE|ln-transformed- AUC0\_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0\_infpred.|Geometric LSM ratio|1.0472|||||TWO_SIDED|90.0|1.0029|1.0934||||||||1.0934|1.0029|
71844870|NCT00366249|143202923|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railker|-5.5||||||95.0|-11.0|0.1|||||Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score|Analysis provided for Cure||0.1|-11.0|
71844871|NCT00366249|143202925|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.7||||||95.0|-12.3|-1.1|||||Adjusted for PEDIS score|Analysis provided for Cure||-1.1|-12.3|
71812316|NCT01376323|143127437|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083|||||TWO_SIDED|95.0|-0.16|-0.007|||||Comparison for NEFA.|||-0.007|-0.160|
71812317|NCT01376323|143127439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.79|0.94||||||||0.94|-0.79|
71844872|NCT00366249|143202927|NON_INFERIORITY_OR_EQUIVALENCE|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.3||||||95.0|-13.6|1.0|||||Adjusted for PEDIS score|||1.0|-13.6|
71844873|NCT01185600|143202950|SUPERIORITY_OR_OTHER|||||||0.142|||||||Fisher Exact|||||||0.142
71844874|NCT01185600|143202951|SUPERIORITY_OR_OTHER|||||||0.0391|||||||Fisher Exact|||||||0.0391
71844875|NCT01185600|143202952|SUPERIORITY_OR_OTHER|||||||0.372|||||||Fisher Exact|||||||0.372
71844876|NCT01185600|143202953|SUPERIORITY_OR_OTHER|||||||0.1007|||||||t-test, 2 sided|||||||0.1007
71844877|NCT01185600|143202954|SUPERIORITY_OR_OTHER|||||||0.0964|||||||t-test, 2 sided|||||||0.0964
71895952|NCT01025336|143313933|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.26|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC - 13vPnC)\].|Serotype 23F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.59|0.26|
71812318|NCT01376323|143127439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.9|0.82||||||||0.82|-0.90|
71812319|NCT01376323|143127439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.9|0.85||||||||0.85|-0.90|
71812320|NCT01376323|143127439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.27|0.42||||||||0.42|-1.27|
71812321|NCT01376323|143127440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.27|||||TWO_SIDED|95.0|-48.62|53.16||||||||53.16|-48.62|
71812322|NCT01376323|143127440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67|||||TWO_SIDED|95.0|-58.04|42.7||||||||42.70|-58.04|
71812323|NCT01376323|143127440|SUPERIORITY_OR_OTHER||Median Difference (Net)|24.08|||||TWO_SIDED|95.0|-27.75|75.92||||||||75.92|-27.75|
71812324|NCT01376323|143127440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.09|||||TWO_SIDED|95.0|-52.72|48.53||||||||48.53|-52.72|
71844878|NCT01185600|143202955|SUPERIORITY_OR_OTHER|||||||0.1739|||||||t-test, 2 sided|||||||0.1739
71844879|NCT01185600|143202956|SUPERIORITY_OR_OTHER|||||||0.7205|||||||t-test, 1 sided|||||||0.7205
71844880|NCT01185600|143202957|SUPERIORITY_OR_OTHER||Negative Binomial|1.64||||0.0176|TWO_SIDED|95.0|1.06|2.55|||t-test, 2 sided||"Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:~(# of AE's, Unwashed Group / (# of AE's, Washed Group) = 1.64 95% C.I. = \[1.06 - 2.55\]"|||2.55|1.06|0.0176
71844881|NCT02941549|143202958|SUPERIORITY||LS Mean Difference|-6.9||||0.5946|TWO_SIDED|95.0|-34.5|20.7|||ANCOVA|||||20.7|-34.5|0.5946
71844882|NCT02941549|143202958|SUPERIORITY||LS Mean Difference|-10.1||||0.7309|TWO_SIDED|95.0|-36.9|16.8|||ANCOVA|||||16.8|-36.9|0.7309
71844883|NCT02941549|143202959|SUPERIORITY||LS Mean Difference|-1.308||||0.0763|TWO_SIDED|95.0|-2.11|-0.51|||ANCOVA|||||-0.51|-2.11|0.0763
71844884|NCT02941549|143202959|SUPERIORITY||LS Mean Difference|-0.727||||0.0058|TWO_SIDED|95.0|-1.554|0.1|||ANCOVA|||||0.100|-1.554|0.0058
71844885|NCT05405244|143202995|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Snack intake||||0.45
71844886|NCT05405244|143202995|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Milkshake intake||||0.28
71844887|NCT05405244|143202996|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Pleasantness||||0.89
71844888|NCT05405244|143202996|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Desire to consume||||<0.001
71844889|NCT03577106|143203048|OTHER||||||<|0.005||||||t(20)=3.3, p\<0.005|paired t-test|||Mean difference using a paired t-test||||<0.005
71895953|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.85|1.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.22|0.85|
71895954|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.10|0.82|
71895955|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.5|||||TWO_SIDED|95.0|0.41|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.69|0.41|
71895956|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.8|||||TWO_SIDED|95.0|0.67|0.87|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.87|0.67|
71895957|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.6|||||TWO_SIDED|95.0|0.48|0.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||0.79|0.48|
71812325|NCT01376323|143127442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.58|||||TWO_SIDED|95.0|-19.36|16.2||||||||16.20|-19.36|
71844890|NCT01500200|143203069|SUPERIORITY|||||||0.014||||||Hypothesis tests were two-sided with an alpha of 0.5.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2.||||0.014
71812326|NCT01376323|143127442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.1|||||TWO_SIDED|95.0|-33.0|2.81||||||||2.81|-33.00|
71812327|NCT01376323|143127442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.09|||||TWO_SIDED|95.0|-32.41|4.23||||||||4.23|-32.41|
71812328|NCT01376323|143127442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|||||TWO_SIDED|95.0|-36.55|-1.68||||||||-1.68|-36.55|
71895958|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.32|2.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.19|1.32|
71895959|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.24|2.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.26|1.24|
71895960|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.48|2.95|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.95|1.48|
71895961|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.23|2.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.05|1.23|
71895962|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.0|||||TWO_SIDED|95.0|0.82|1.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.19|0.82|
71895963|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.46|1.07|
71812329|NCT04681729|143127444|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9492|TWO_SIDED|95.0|0.41|2.56||Cochran-Mantel-Haenszel test was performed on the association between the ice cube provocation test result and intervention group, stratified by region and background H1-antihistamine regular/daily use (Yes or No). Threshold of significance at 0.01.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control the family-wise type-I error. Testing was then performed sequentially in order the endpoints were reported and continued when primary endpoint was statistically significant at two-sided 0.01.||2.56|0.41|0.9492
71812330|NCT04766086|143127497|OTHER||Risk difference|0.0||||||95.0|-3.8|3.7||||||||3.7|-3.8|
71812331|NCT04766086|143127498|OTHER||GMR|0.546|||||TWO_SIDED|95.0|0.405|0.736||||||GMR for Anti-PT Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.736|0.405|
71812332|NCT04766086|143127498|OTHER||GMR|0.567|||||TWO_SIDED|95.0|0.455|0.707||||||GMR for Anti-FHA Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.707|0.455|
71812333|NCT04766086|143127498|OTHER||GMR|0.588|||||TWO_SIDED|95.0|0.451|0.766||||||GMR for Anti-PRN Antibody: GMR for GBS6 + Tdap/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||0.766|0.451|
71812334|NCT04766086|143127499|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.38|2.089||||||GMR for serotype Ia: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.089|0.380|
71812335|NCT04766086|143127499|OTHER||GMR|1.149|||||TWO_SIDED|95.0|0.455|2.901||||||GMR for serotype Ib: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.901|0.455|
71812336|NCT04766086|143127499|OTHER||GMR|1.032||||||95.0|0.551|1.931||||||GMR for serotype II: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.931|0.551|
71812337|NCT04766086|143127499|OTHER||GMR|0.635|||||TWO_SIDED|95.0|0.303|1.329||||||GMR for serotype III: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.329|0.303|
71812338|NCT04766086|143127499|OTHER||GMR|1.474|||||TWO_SIDED|95.0|0.842|2.58||||||GMR for serotype IV: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||2.580|0.842|
71812339|NCT04766086|143127499|OTHER||GMR|0.559|||||TWO_SIDED|95.0|0.232|1.349||||||GMR for serotype V: GMR for GBS6 + GBS6/Placebo + Tdap was calculated by back transforming the mean difference between the 2 measures on the logarithmic scale.||1.349|0.232|
71812340|NCT02496767|143127512|SUPERIORITY||Least squares mean difference|1.707|STANDARD_ERROR_OF_MEAN|1.9365||0.3782|TWO_SIDED|95.0|-2.089|5.503|||Repeated-measures mixed model|||||5.503|-2.089|0.3782
71812341|NCT02496767|143127512|SUPERIORITY||Least squares mean difference|0.612|STANDARD_ERROR_OF_MEAN|2.0245||0.7625|TWO_SIDED|95.0|-3.359|4.583|||Repeated-measures mixed model|||||4.583|-3.359|0.7625
71812342|NCT02496767|143127512|SUPERIORITY||Least squares mean difference|0.428|STANDARD_ERROR_OF_MEAN|2.1081||0.8394|TWO_SIDED|95.0|-3.711|4.566|||Repeated-measures mixed model|||||4.566|-3.711|0.8394
71812343|NCT02496767|143127513|SUPERIORITY||Least squares mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.41||0.4521|TWO_SIDED|95.0|-0.5|1.12|||Repeated-measures mixed model|||||1.12|-0.50|0.4521
71812344|NCT02496767|143127513|SUPERIORITY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.426||0.712|TWO_SIDED|95.0|-1.0|0.68|||Repeated-measures mixed model|||||0.68|-1.00|0.7120
71812345|NCT02496767|143127513|SUPERIORITY||Least squares mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.439||0.451|TWO_SIDED|95.0|-1.19|0.53|||Repeated-measures mixed model|||||0.53|-1.19|0.4510
71812346|NCT02496767|143127514|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9505|TWO_SIDED|95.0|-0.0374|0.0351|||Repeated-measures mixed model|||||0.0351|-0.0374|0.9505
71812347|NCT02496767|143127514|SUPERIORITY||Mean Difference (Final Values)|0.0066||||0.7336|TWO_SIDED|95.0|-0.0317|0.045|||Repeated-measures mixed model|||||0.0450|-0.0317|0.7336
71812348|NCT02496767|143127514|SUPERIORITY||Mean Difference (Final Values)|0.0088||||0.6593|TWO_SIDED|95.0|-0.0303|0.0479|||Repeated-measures mixed model|||||0.0479|-0.0303|0.6593
71844891|NCT01500200|143203069|SUPERIORITY|||||||0.699||||||Hypothesis tests were two-sided with an alpha of 0.05.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.||||0.699
71812349|NCT02496767|143127515|SUPERIORITY||Hazard Ratio (HR)|0.818||||0.2369|TWO_SIDED|95.0|0.587|1.141|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.141|0.587|0.2369
71812350|NCT02496767|143127515|SUPERIORITY||Hazard Ratio (HR)|0.988||||0.942|TWO_SIDED|95.0|0.711|1.372|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.372|0.711|0.9420
71812351|NCT02496767|143127515|SUPERIORITY||Hazard Ratio (HR)|0.933||||0.6853|TWO_SIDED|95.0|0.668|1.304|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.304|0.668|0.6853
71812352|NCT02496767|143127516|SUPERIORITY||Hazard Ratio (HR)|1.066||||0.7667|TWO_SIDED|95.0|0.698|1.627|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.627|0.698|0.7667
71812353|NCT02496767|143127516|SUPERIORITY||Hazard Ratio (HR)|0.904||||0.6619|TWO_SIDED|95.0|0.577|1.419|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.419|0.577|0.6619
71812354|NCT02496767|143127516|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.5856|TWO_SIDED|95.0|0.561|1.386|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.386|0.561|0.5856
71812355|NCT02496767|143127517|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.103||0.9991|TWO_SIDED|95.0|-2.17|2.17|||Repeated-measures mixed model|||||2.17|-2.17|0.9991
71812356|NCT02496767|143127517|SUPERIORITY||Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.138||0.4808|TWO_SIDED|95.0|-3.04|1.43|||Repeated-measures mixed model|||||1.43|-3.04|0.4808
71812357|NCT02496767|143127517|SUPERIORITY||Least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.165||0.6082|TWO_SIDED|95.0|-2.89|1.69|||Repeated-measures mixed model|||||1.69|-2.89|0.6082
71812358|NCT02496767|143127518|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.2602|TWO_SIDED|95.0|0.5|1.206|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.206|0.500|0.2602
71812359|NCT02496767|143127518|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.6748|TWO_SIDED|95.0|0.72|1.662|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.662|0.720|0.6748
71812360|NCT02496767|143127518|SUPERIORITY||Hazard Ratio (HR)|0.938||||0.7694|TWO_SIDED|95.0|0.609|1.443|||Regression, Cox||Hazard ratio for tirasemtiv vs placebo|||1.443|0.609|0.7694
71812361|NCT04506775|143127585|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.|Mean Error|0.9|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \<5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively.||||||||
71844892|NCT03066609|143203119|SUPERIORITY||Odds Ratio (OR)|153.94|||<|0.0001|TWO_SIDED|95.0|54.02|438.67|||Regression, Logistic|||PASI 75||438.67|54.02|<0.0001
71844893|NCT03066609|143203119|SUPERIORITY||Odds Ratio (OR)|557.98|||<|0.0001|TWO_SIDED|95.0|187.2|1663.4|||Regression, Logistic|||PASI 75||1663.4|187.2|<0.0001
71844894|NCT03066609|143203120|SUPERIORITY||Odds Ratio (OR)|75.82|||<|0.0001|TWO_SIDED|95.0|25.81|222.72|||Regression, Logistic|||IGA||222.72|25.81|<0.0001
71844895|NCT03066609|143203120|SUPERIORITY||Odds Ratio (OR)|149.71|||<|0.0001|TWO_SIDED|95.0|51.83|432.42|||Regression, Logistic|||IGA||432.42|51.83|<0.0001
71844896|NCT03066609|143203121|SUPERIORITY||Odds Ratio (OR)|114.85|||<|0.0001|TWO_SIDED|95.0|26.94|489.59|||Regression, Logistic|||PASI 90||489.59|26.94|<0.0001
71844897|NCT03066609|143203121|SUPERIORITY||Odds Ratio (OR)|246.12|||<|0.0001|TWO_SIDED|95.0|58.41|1037.1|||Regression, Logistic|||PASI 90||1037.1|58.41|<0.0001
71844898|NCT01499849|143203159|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.3|2.7||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.7|1.3|<0.001
71844899|NCT01499849|143203160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.005|TWO_SIDED|95.0|1.2|2.8||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.8|1.2|0.005
71844900|NCT01499849|143203161|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.001|TWO_SIDED|95.0|1.3|2.6||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.6|1.3|0.001
71844901|NCT00174252|143203163|SUPERIORITY_OR_OTHER||Percentage|86.0|||||TWO_SIDED|95.0|74.2|93.7|||||95% CI was estimated using the F-distribution.|"Applies to no."||93.7|74.2|
71844902|NCT00174252|143203163|SUPERIORITY_OR_OTHER||Percentage|14.0||||||95.0|6.3|25.8|||||95% confidence interval (CI) was estimated using the F-distribution.|"Applies to yes."||25.8|6.3|
71844903|NCT00174252|143203177|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.002||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.002
71844904|NCT00174252|143203178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.023||95.0||||Bilateral test multiple comparison threshold for statistical significance = 0.05|ANCOVA|Adjusted for height SD at baseline.||||||0.023
71844905|NCT00174252|143203179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.708||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.708
71844906|NCT00174252|143203180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.325||95.0|||||ANCOVA|Adjusted for height SD at baseline.||||||0.325
71844907|NCT03170882|143203188|SUPERIORITY||Hazard Ratio (HR)|0.847|||=|0.477|TWO_SIDED|95.0|0.535|1.341|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age,international staging system(ISS),prior lines of therapy. HR\<1 was deemed to indicate better PFS in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.341|0.535|=0.477
71844908|NCT03170882|143203189|SUPERIORITY||Hazard Ratio (HR)|1.427|||=|0.265|TWO_SIDED|95.0|0.761|2.677|||Log Rank||HR obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS and prior lines of therapy. HR \<1 was deemed to indicate longer survival time in Ixazomib + Dexamethasone arm as compared to Pomalidomide + Dexamethasone arm.|||2.677|0.761|=0.265
71844909|NCT03170882|143203190|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.634|TWO_SIDED|95.0|0.43|1.9|||Cochran-Mantel-Haenszel||OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.90|0.43|=0.634
71844910|NCT03170882|143203192|SUPERIORITY||Hazard Ratio (HR)|0.556|||||TWO_SIDED|95.0|0.288|1.073|||||HR was obtained by unadjusted Cox's proportional hazard regression model stratified by age, ISS, prior lines of therapy. HR \>1 was deemed to indicate quicker response time in Ixazomib + Dexamethasone arm over Pomalidomide + Dexamethasone arm.|||1.073|0.288|
71844911|NCT03170882|143203193|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.459|TWO_SIDED|95.0|0.506|1.361|||Log Rank||HR: obtained by unadjusted Cox's proportional hazard regression model stratified by age,ISS,prior lines of therapy. HR\<1 was deemed to indicate better disease progression prevention in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.|||1.361|0.506|=0.459
71844912|NCT00811941|143203203|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.62||0.16|TWO_SIDED|95.0|-2.1|0.35|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. Null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||0.35|-2.10|0.160
71844913|NCT00811941|143203204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|STANDARD_ERROR_OF_MEAN|2.9||0.232|TWO_SIDED|95.0|-9.17|2.23|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."||2.23|-9.17|0.232
71844914|NCT00811941|143203205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.689|TWO_SIDED|95.0|0.59|1.41|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.41|0.59|0.689
71676884|NCT02120833|142871950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.07||0.3599|TWO_SIDED|95.0|-0.08|0.22||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.08|0.3599
71812362|NCT04506775|143127586|NON_INFERIORITY|As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|Mean Error|0.19|||||TWO_SIDED|||||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively||As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be \< 5mmHg or \<6mmHg and the standard deviation should be \<8mmHg or \<10mmHg respectively|||
71812363|NCT00279201|143127588|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.||||||0.005
71812364|NCT00279201|143127589|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|Stratified by country, thiazolidinedione (TZD) use, sulfo use.||||||0.040
71812365|NCT00279201|143127590|SUPERIORITY_OR_OTHER|||||||0.271||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
71812366|NCT00279201|143127590|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
71812367|NCT00279201|143127591|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||0.005
71812368|NCT00279201|143127592|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.002
71812369|NCT00279201|143127592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for \<7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||<0.001
71812370|NCT00279201|143127592|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.174
71812371|NCT00279201|143127593|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.416
71812372|NCT00279201|143127593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812373|NCT00279201|143127593|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.003
71812374|NCT00279201|143127593|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
71812375|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.179
71812376|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812377|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||P-value is for Baseline AM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.700
71812378|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for AM 2-hour postprandial blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.016
71676885|NCT02120833|142871951|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0001
71812379|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.971||95.0||||P-value is for Baseline midday premeal BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.971
71812380|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Midday premeal blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812381|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.759||95.0||||P-value is for Baseline midday 2-hour postprandial BG|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.||||||0.759
71812382|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value Midday 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.514
71812383|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.321||95.0||||P-value is for Baseline evening pre-meal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.321
71812384|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value for Evening pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.161
71812385|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||P-value is for Baseline evening 2hour postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.297
71812386|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value Evening 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812387|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Baseline 3 AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.199
71812388|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.693||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.693
71812389|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Baseline AM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.021
71812390|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812391|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value is for Baseline midday 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.567
71676886|NCT02120833|142871951|SUPERIORITY_OR_OTHER|||||||0.0317|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0317
71844915|NCT00811941|143203206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.09||0.046|TWO_SIDED|95.0|-0.37|0.0|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||-0.00|-0.37|0.046
71844916|NCT00811941|143203207|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11||0.217|TWO_SIDED|95.0|-0.36|0.08|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||0.08|-0.36|0.217
71844917|NCT00811941|143203208|SUPERIORITY_OR_OTHER||Ratio to placebo|0.93||||0.273|TWO_SIDED|95.0|0.83|1.05|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 319 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||1.05|0.83|0.273
71844918|NCT00811941|143203209|SUPERIORITY_OR_OTHER||Ratio to placebo|0.99||||0.916|TWO_SIDED|95.0|0.9|1.1|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 318 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.||1.10|0.90|0.916
71844919|NCT00811941|143203210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.65||0.017|TWO_SIDED|95.0|-2.85|-0.29|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.29|-2.85|0.017
71844920|NCT00811941|143203211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47|STANDARD_ERROR_OF_MEAN|3.07||0.036|TWO_SIDED|95.0|-12.53|-0.42|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.||-0.42|-12.53|0.036
71844921|NCT00811941|143203212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.976|TWO_SIDED|95.0|0.67|1.52|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.||1.52|0.67|0.976
71844922|NCT00811941|143203213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.056|TWO_SIDED|95.0|-0.44|0.01|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.||0.01|-0.44|0.056
71844923|NCT00811941|143203214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.029||95.0|-0.5|-0.03|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.||-0.03|-0.50|0.029
71844924|NCT00811941|143203215|SUPERIORITY_OR_OTHER||Ratio to placebo|0.78||||0.001|TWO_SIDED|95.0|0.67|0.9|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 98 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.90|0.67|0.001
71844925|NCT00811941|143203216|SUPERIORITY_OR_OTHER||Ratio to placebo|0.88||||0.037|TWO_SIDED|95.0|0.79|0.99|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.||0.99|0.79|0.037
71844926|NCT03802994|143203217|EQUIVALENCE|Differences between groups were compared using the paired t test|||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||Differences between groups were compared using the paired t test||||<0.05
71812392|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value is for Midday 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.005
71812393|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.994||95.0||||P-value is for Baseline PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.994
71812394|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812395|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.436
71812396|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812397|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.628||95.0||||P-value is for Baseline mean all 2hour PP BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.628
71812398|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Mean of all 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812399|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.677||95.0||||P-value is for Baseline AM/PM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.677
71812400|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812401|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value is for Baseline mean all premeal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.364
71812402|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is for Mean of all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.055
71812403|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Baseline AM/PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.165
71812404|NCT00279201|143127594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for AM/PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812405|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||P-value is for Baseline mean of all BG values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.464
71812406|NCT00279201|143127594|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for Mean of all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||0.305
71812407|NCT00279201|143127595|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|ANCOVA model with treatment, baseline, country, TZD use, and sulfo use.||||||0.003
71812408|NCT00279201|143127596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 6.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812409|NCT00279201|143127596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 12.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812410|NCT00279201|143127596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 18|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71844927|NCT03802994|143203217|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71812411|NCT00279201|143127596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812412|NCT00279201|143127596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change from baseline at endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812413|NCT00279201|143127597|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Actual weight at baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.497
71812414|NCT00279201|143127597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.||||||<0.001
71812415|NCT00279201|143127597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Actual weight at Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
71812416|NCT00279201|143127597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 18.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
71812417|NCT00279201|143127597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Actual weight at Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.001
71812418|NCT00279201|143127597|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Actual weight at Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.||||||<0.0001
71812419|NCT00279201|143127598|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value is for Hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.016
71812420|NCT00279201|143127598|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Overall hypoglycemic episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.037
71812421|NCT00279201|143127598|SUPERIORITY_OR_OTHER|||||||0.834||95.0||||P-value is for Nocturnal hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.834
71812422|NCT00279201|143127598|SUPERIORITY_OR_OTHER|||||||0.585||95.0||||P-value is for Nocturnal hypoglycemic episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.585
71812423|NCT00279201|143127598|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Severe hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.241
71812424|NCT00279201|143127598|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||P-value is for Severe hypoglycemic episodes overall. Initiation phase and maintenance phase are included.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.080
71812425|NCT00279201|143127599|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.009
71676887|NCT02120833|142871951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.19||0.8037|TWO_SIDED|95.0|-0.42|0.33||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.33|-0.42|0.8037
71676888|NCT02120833|142871952|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71812426|NCT00279201|143127599|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.420
71812427|NCT00279201|143127599|SUPERIORITY_OR_OTHER|||||||0.165||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.165
71812428|NCT00279201|143127599|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.167
71812429|NCT00279201|143127599|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.006
71812430|NCT00279201|143127599|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||<0.001
71676889|NCT02120833|142871952|SUPERIORITY_OR_OTHER|||||||0.0244|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0244
71812431|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812432|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812433|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812434|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812435|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812436|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71676890|NCT02120833|142871952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.8|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.06|-0.80|0.0900
71812437|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812438|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812439|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812440|NCT00279201|143127600|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is for Week 18.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||0.001
71812441|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812442|NCT00279201|143127600|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.||||||<0.001
71812443|NCT00279201|143127601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812444|NCT00279201|143127602|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||<0.001
71812445|NCT00279201|143127603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812446|NCT00279201|143127604|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use and Sulfo use in model.||||||<0.001
71812447|NCT00279201|143127605|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
71812448|NCT00279201|143127606|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812449|NCT00279201|143127607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Pre Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812450|NCT00279201|143127607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Post Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812451|NCT00279201|143127607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Average of All Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812452|NCT00279201|143127607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Fasting Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.||||||<0.001
71812453|NCT00279201|143127608|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Sulfonylurea/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
71844928|NCT03802994|143203217|SUPERIORITY||||||<|0.05|TWO_SIDED|80.0|||||t-test, 2 sided|||||||<0.05
71844929|NCT03802994|143203218|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71812454|NCT00279201|143127608|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for TZD/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||<0.001
71812455|NCT00279201|143127608|SUPERIORITY_OR_OTHER|||||||0.969||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.969
71812456|NCT00279201|143127608|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value is for Patients with 3 drugs (Sulfonylurea/TZD/Metformin).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.225
71812457|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Week 0.|ANOVA|ANCOVA used with treatment, country, TZD use, and sulfo use in the model.||||||0.204
71812458|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Week 12.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.004
71812459|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Week 24.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.657
71812460|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.595||95.0||||P-value is for Week 36.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.595
71812461|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value for Week 48.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.142
71812462|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.551||95.0||||P-value for Week 60.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.551
71812463|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.779||95.0||||P-value is for Week 72.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.779
71812464|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Week 84.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.175
71812465|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||P-value for Week 96.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.018
71812466|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value is for Week 108.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.047
71812467|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for Week 120.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.027
71812468|NCT00279201|143127609|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value is for Endpoint.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.017
71812469|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.218
71844930|NCT03802994|143203218|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71812470|NCT00279201|143127610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
71812471|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.897||95.0||||P-value is for Baseline AM 2-hour (hr) postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.897
71812472|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.138||95.0||||P-value is for Endpoint AM 2-hour postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.138
71812473|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.867||95.0||||P-value is for Baseline midday premeal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.867
71812474|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Endpoint midday premeal blood.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.031
71812475|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value is for Baseline midday 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.792
71812476|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||P-value is for Endpoint midday 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.510
71812477|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.535||95.0||||P-value is for Baseline PM pre-meal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.535
71812478|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.517||95.0||||P-value is for Endpoint PM pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.517
71812479|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.869||95.0||||P-value is for Baseline PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.869
71812480|NCT00279201|143127610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
71844931|NCT03802994|143203219|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71812481|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.164||95.0||||P-value is for Baseline 3AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.164
71844932|NCT03802994|143203220|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71812482|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.234||95.0||||P-value is for Endpoint 3AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.234
71812483|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.175||95.0||||P-value is for Baseline AM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.175
71812484|NCT00279201|143127610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
71812485|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.589||95.0||||P-value is for Baseline midday 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.589
71812486|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Endpoint midday 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.161
71812487|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.674||95.0||||P-value is for Baseline PM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.674
71812488|NCT00279201|143127610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint PM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
71812489|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.201
71812490|NCT00279201|143127610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint mean all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
71812491|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.956||95.0||||P-value is for Baseline mean of all 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.956
71812492|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value is for Endpoint mean of all 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.019
71844933|NCT00622700|143203235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.574||||0.0087|TWO_SIDED|95.0|0.379|0.869||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.869|0.379|0.0087
71844934|NCT00622700|143203235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0271|TWO_SIDED|95.0|0.416|0.949||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.949|0.416|0.0271
71844935|NCT00622700|143203236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.651||||0.0003|TWO_SIDED|95.0|0.515|0.822||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.822|0.515|0.0003
71844936|NCT00622700|143203236|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.686||||0.002|TWO_SIDED|95.0|0.54|0.871||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.||0.871|0.540|0.0020
71844937|NCT02392234|143203257|SUPERIORITY||Least Squares (LS) Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.7|5.8|||Linear Mixed Effects Model|||||5.8|3.7|< 0.0001
71844938|NCT02392234|143203257|SUPERIORITY||LS Mean Difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.7|7.8|||Linear Mixed Effects Model|||||7.8|5.7|< 0.0001
71844939|NCT02392234|143203258|SUPERIORITY||LS Mean Difference|9.7|||<|0.0001|TWO_SIDED|95.0|7.2|12.2|||Linear Mixed Effects Model|||||12.2|7.2|<0.0001
71844940|NCT02392234|143203258|SUPERIORITY||LS Mean Difference|11.1|||<|0.0001|TWO_SIDED|95.0|8.7|13.6|||Linear Mixed Effects Model|||||13.6|8.7|<0.0001
71844941|NCT02392234|143203260|SUPERIORITY||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|6.3|9.9|||Linear Mixed Effects Model|||||9.9|6.3|<0.0001
71844942|NCT02392234|143203260|SUPERIORITY||LS Mean Difference|11.4|||<|0.0001|TWO_SIDED|95.0|9.6|13.2|||Linear Mixed Effects Model|||||13.2|9.6|<0.0001
71844943|NCT02392234|143203261|SUPERIORITY||LS Mean Difference|-4.5|||<|0.0001|TWO_SIDED|95.0|-6.7|-2.3|||Linear Mixed Effects Model|||||-2.3|-6.7|<0.0001
71844944|NCT02392234|143203261|SUPERIORITY||LS Mean Difference|-9.5|||<|0.0001|TWO_SIDED|95.0|-11.7|-7.3|||Linear Mixed Effects Model|||||-7.3|-11.7|<0.0001
71895964|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.56|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.80|1.56|
71895965|NCT01025336|143313934|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.1|||||TWO_SIDED|95.0|0.89|1.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.48|0.89|
71895966|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.48|0.92|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 1: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.92|0.48|
71895967|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.76|1.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 3: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.28|0.76|
71895968|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.88|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 4: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.22|0.88|
71895969|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|1.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 5: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.95|0.93|
71895970|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|0.4|||||TWO_SIDED|95.0|0.27|0.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||0.66|0.27|
71895971|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.64|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 6B: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.56|0.64|
71895972|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.14|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 7F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||3.04|1.14|
71895973|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.7|||||TWO_SIDED|95.0|1.01|2.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 9V: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.85|1.01|
71895974|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.26|2.87|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 14: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.87|1.26|
71895975|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.57|1.19|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 18C: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.19|0.57|
71895976|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.0|||||TWO_SIDED|95.0|0.75|1.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.31|0.75|
71895977|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|1.4|||||TWO_SIDED|95.0|0.93|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 19F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||2.04|0.93|
71844945|NCT02415127|143203267|SUPERIORITY|||||||0.5442||||||From a repeated-measures ANCOVA with fixed effects of treatment, visit, and treatment\*visit with baseline score and investigative site as covariates using an unstructured covariance matrix, testing ACTIMMUNE® vs placebo.|ANCOVA|||The primary and secondary efficacy endpoints were tested in a hierarchical manner. Each endpoint was tested in sequential order and the current endpoint must have shown statistical significance (p \< 0.05) prior to performing testing the next endpoint. The primary endpoint, FARS-mNeuro, was to be tested first, followed by the key secondary endpoint, ADL, followed by the other secondary endpoints, T25FW, FARS-mNeuro responder rate, and FARStot.||||0.5442
71844946|NCT01855750|143203272|SUPERIORITY||Hazard Ratio (HR)|0.922||||0.5167|TWO_SIDED|95.0|0.72|1.18|||Log Rank|||||1.180|0.720|0.5167
71844947|NCT01855750|143203273|SUPERIORITY||Hazard Ratio (HR)|0.949||||0.7311|TWO_SIDED|95.0|0.704|1.279|||Log Rank|||||1.279|0.704|0.7311
71844948|NCT01855750|143203274|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.5027|TWO_SIDED|95.0|0.71|1.183|||Log Rank|||||1.183|0.710|0.5027
71844949|NCT01855750|143203275|SUPERIORITY||Odds Ratio (OR)|0.967||||0.8229|TWO_SIDED|95.0|0.722|1.296|||Cochran-Mantel-Haenszel (CMH) Chi-square|||||1.296|0.722|0.8229
71844950|NCT01855750|143203276|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8549|TWO_SIDED|95.0|0.754|1.407|||Log Rank|||||1.407|0.754|0.8549
71844951|NCT01855750|143203277|SUPERIORITY||Hazard Ratio (HR)|1.358||||0.0021|TWO_SIDED|95.0|1.115|1.654|||Log Rank|||||1.654|1.115|0.0021
71844952|NCT03762850|143203340|OTHER||Geometric Mean Ratio|0.59|||<|0.0001|TWO_SIDED|95.0|0.51|0.69|||Mixed Models Analysis|||||0.69|0.51|<0.0001
71844953|NCT03762850|143203341|OTHER||Slope difference|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0582|TWO_SIDED|95.0|-0.03|1.94|||Mixed Models Analysis|||||1.94|-0.03|0.0582
71844954|NCT03762850|143203342|OTHER||Slope difference|1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0369|TWO_SIDED|95.0|0.07|2.12|||Mixed Models Analysis|||||2.12|0.07|0.0369
71844955|NCT00979459|143203365|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the AUC(0 to infinity) geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.86|0.99||||||||0.99|0.86|
71844956|NCT00979459|143203366|NON_INFERIORITY_OR_EQUIVALENCE|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the Cmax geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|1.07|||||TWO_SIDED|90.0|0.92|1.24||||||||1.24|0.92|
71844957|NCT04503681|143203376|SUPERIORITY||Median Difference (Final Values)|0.0||||0.473|TWO_SIDED|95.0|-1.1|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|-1.1|0.473
71844958|NCT04503681|143203377|SUPERIORITY||Median Difference (Final Values)|0.0||||0.338|TWO_SIDED|95.0|-0.8|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|-0.8|0.338
71844959|NCT03849937|143203405|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71844960|NCT03849937|143203405|SUPERIORITY|||||||0.091||||||Time 1 to Time 2|t-test, 2 sided|||||||.091
71844961|NCT03849937|143203405|SUPERIORITY||||||<|0.001||||||Time 2 to Time 3|t-test, 2 sided|||||||<.001
71844962|NCT03849937|143203406|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Effective Communication||||<.001
71844963|NCT03849937|143203406|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Appropriate Communication||||<.001
71844964|NCT03849937|143203406|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes elderspeak||||<.001
71844965|NCT03849937|143203406|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Recognizes person-centered communication||||<.001
71844966|NCT02760654|143203450|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71844967|NCT02760654|143203451|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71844968|NCT02760654|143203452|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71844969|NCT02760654|143203453|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71844970|NCT02760654|143203454|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71844971|NCT02760654|143203455|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71844972|NCT02760654|143203456|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71844973|NCT02760654|143203457|EQUIVALENCE|Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale|Calculated Mean and Standard Deviation|0.05|||||TWO_SIDED|||||||||||||
71844974|NCT02760654|143203458|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71812493|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Baseline mean all premeal.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.445
71812494|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.371||95.0||||P-value is for Endpoint mean all premeal.|ANOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.371
71676891|NCT02120833|142871953|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71812495|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Baseline combined AM/PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.848
71812496|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Endpoint combined AM/PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.002
71812497|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value is for Baseline AM/PM 2hr postprandial excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.281
71812498|NCT00279201|143127610|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint AM/PM 2hr postprandial excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||<0.001
71812499|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.588||95.0||||P-value is for Baseline mean all blood glucose values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.588
71812500|NCT00279201|143127610|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P-value is for Endpoint mean all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.||||||0.217
71812501|NCT00279201|143127611|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use, and sulfo use in the model.||||||0.300
71812502|NCT00279201|143127612|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for \<=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.134
71812503|NCT00279201|143127612|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value is for \<7.0%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.089
71812504|NCT00279201|143127612|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||P-value is for \<=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.235
71812505|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812506|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 36.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812507|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 48.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812508|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 60.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812509|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 72.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812510|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 84.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812511|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 96.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812512|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Week 108|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812513|NCT00279201|143127613|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Change from baseline at Week 120.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||0.002
71812514|NCT00279201|143127613|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Change from baseline at Endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.||||||<0.001
71812515|NCT00279201|143127614|SUPERIORITY_OR_OTHER|||||||0.128||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.||||||0.128
71812516|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812517|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812518|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812519|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812520|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812521|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812522|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812523|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812524|NCT00279201|143127614|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is for Week 120.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||0.002
71812525|NCT00279201|143127614|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.||||||<0.001
71812526|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 24.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812527|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 36.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71676892|NCT02120833|142871953|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0065
71812528|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 48.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812529|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 60.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812530|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 72.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71844975|NCT02760654|143203459|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71844976|NCT03601715|143203466|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
71844977|NCT03601715|143203467|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
71844978|NCT03601715|143203468|SUPERIORITY||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).|||<0.05
71844979|NCT00918333|143203471|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|40.0|||||TWO_SIDED|||||||||||||
71844980|NCT04191824|143203493|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.7769|TWO_SIDED|95.0|-2.7|2.1||In order to maintain an overall alpha of 0.05 and account for two interim analyses, a two-sided alpha of 0.0492 was used for assessing the statistical significance in the final analysis of this primary endpoint.|t-test, 2 sided|||||2.1|-2.7|0.7769
71676893|NCT02120833|142871953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.28||0.1561|TWO_SIDED|95.0|-0.97|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.16|-0.97|0.1561
71812531|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 84.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812532|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 96.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812533|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 108.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812534|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Week 120.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71844981|NCT04191824|143203494|SUPERIORITY||Risk Difference (RD)|0.106|||<|0.0001|TWO_SIDED|95.0|0.061|0.151|||Chi-squared|||||0.151|0.061|<0.0001
71844982|NCT04191824|143203495|SUPERIORITY||Risk Difference (RD)|0.057||||0.0753|TWO_SIDED|95.0|-0.006|0.12|||Chi-squared|||||0.120|-0.006|0.0753
71844983|NCT04191824|143203496|SUPERIORITY||Risk Difference (RD)|0.002||||0.8044|TWO_SIDED|95.0|-0.013|0.016|||Chi-squared|||||0.016|-0.013|0.8044
71844984|NCT04191824|143203497|SUPERIORITY||Risk Difference (RD)|-0.052||||0.057|TWO_SIDED|95.0|-0.105|0.002|||Chi-squared|||||0.002|-0.105|0.0570
71844985|NCT04191824|143203498|SUPERIORITY||Risk Difference (RD)|0.045||||0.0012|TWO_SIDED|95.0|0.018|0.072|||Chi-squared|||||0.072|0.018|0.0012
71844986|NCT04191824|143203499|SUPERIORITY||Risk Difference (RD)|-0.006||||0.8483|TWO_SIDED|95.0|-0.066|0.055|||Chi-squared|||||0.055|-0.066|0.8483
71844987|NCT03611556|143203514|SUPERIORITY||Rate difference|-8.0||||0.3614|TWO_SIDED|95.0|-27.6|12.1||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by cluster of differentiation 73 (CD73) level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -20.9 to 5.2|12.1|-27.6|0.3614
71844988|NCT03611556|143203514|SUPERIORITY||Rate difference|3.8||||0.6503|TWO_SIDED|95.0|-13.2|20.7||Nominal P-value for comparison of treatment groups obtained from Cochran-Mantel-Haenszel-test was stratified by CD73 level.|Cochran-Mantel-Haenszel||||80% Confidence Interval 2-Sided: -7.4 to 15.0|20.7|-13.2|0.6503
71844989|NCT03611556|143203521|SUPERIORITY||Hazard Ratio (HR)|1.26|||||TWO_SIDED|95.0|0.79|1.983|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.983|0.790|
71844990|NCT03611556|143203521|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.498|1.131|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.131|0.498|
71844991|NCT03611556|143203523|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.726|1.837|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.837|0.726|
71812535|NCT00279201|143127615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Endpoint.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.||||||<0.001
71812536|NCT00279201|143127616|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||P-value is for Overall hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.370
71812537|NCT00279201|143127616|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-Value for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.006
71812538|NCT00279201|143127616|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.397
71812539|NCT00279201|143127616|SUPERIORITY_OR_OTHER|||||||0.253||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.253
71812540|NCT00279201|143127616|SUPERIORITY_OR_OTHER|||||||0.893||95.0||||P-value is for Severe episodes endpoint.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.||||||0.893
71844992|NCT03611556|143203523|SUPERIORITY||Hazard Ratio (HR)|0.719|||||TWO_SIDED|95.0|0.468|1.105|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model stratified by CD73 level with ties handled by the Efron method.|||1.105|0.468|
71844993|NCT03611556|143203527|SUPERIORITY||Rate difference|-1.7|||||TWO_SIDED|95.0|-25.2|21.9||||||||21.9|-25.2|
71844994|NCT03611556|143203527|SUPERIORITY||Rate difference|7.5|||||TWO_SIDED|95.0|-12.6|27.0||||||||27.0|-12.6|
71844995|NCT03611556|143203527|SUPERIORITY||Rate difference|-25.6|||||TWO_SIDED|95.0|-58.3|13.9||||||||13.9|-58.3|
71895978|NCT01025336|143313935|SUPERIORITY_OR_OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(23vPS/13vPnC-13vPnC)\].|Serotype 23F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.||1.15|0.50|
71676894|NCT02120833|142871954|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71812541|NCT00279201|143127616|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.||||||0.391
71812542|NCT00279201|143127617|SUPERIORITY_OR_OTHER|||||||0.497||95.0||||P-value for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.497
71812543|NCT00279201|143127617|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.071
71812544|NCT00279201|143127617|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.065
71812545|NCT00279201|143127617|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.021
71812546|NCT00279201|143127617|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.200
71812547|NCT00279201|143127617|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.208
71812548|NCT00279201|143127618|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, TZD use and sulfo use.||||||0.004
71844996|NCT03611556|143203527|SUPERIORITY||Rate difference|-6.9|||||TWO_SIDED|95.0|-39.1|26.6||||||||26.6|-39.1|
71844997|NCT03611556|143203528|SUPERIORITY||Hazard Ratio (HR)|1.173|||||TWO_SIDED|95.0|0.676|1.985|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.985|0.676|
71844998|NCT03611556|143203528|SUPERIORITY||Hazard Ratio (HR)|0.605|||||TWO_SIDED|95.0|0.377|0.968|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.968|0.377|
71844999|NCT03611556|143203528|SUPERIORITY||Hazard Ratio (HR)|1.549|||||TWO_SIDED|95.0|0.622|3.917|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.917|0.622|
71845000|NCT03611556|143203528|SUPERIORITY||Hazard Ratio (HR)|1.472|||||TWO_SIDED|95.0|0.638|3.576|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.576|0.638|
71845001|NCT03611556|143203530|SUPERIORITY||Hazard Ratio (HR)|1.004|||||TWO_SIDED|95.0|0.584|1.693|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||1.693|0.584|
71845002|NCT03611556|143203530|SUPERIORITY||Hazard Ratio (HR)|0.598|||||TWO_SIDED|95.0|0.366|0.973|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||0.973|0.366|
71845003|NCT03611556|143203530|SUPERIORITY||Hazard Ratio (HR)|1.933|||||TWO_SIDED|95.0|0.716|5.437|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||5.437|0.716|
71845004|NCT03611556|143203530|SUPERIORITY||Hazard Ratio (HR)|1.374|||||TWO_SIDED|95.0|0.55|3.707|||||Hazard ratio for comparison between treatment groups obtained from Cox Proportional Hazards model with ties handled by the Efron method.|||3.707|0.550|
71845005|NCT02646618|143203539|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|2.0||||0.0038|TWO_SIDED|95.0|0.6|3.3|||Mixed Models Analysis|||||3.3|0.6|0.0038
71845006|NCT02646618|143203540|NON_INFERIORITY|We set δ=2% as a relative margin to the 5% weight loss as clinically meaningful cut point and because 2% is not so small a difference in average weight loss between study conditions that we would have to recruit a prohibitively large sample.|Mean Difference (Net)|1.2||||0.1485|TWO_SIDED|95.0|-0.4|2.8|||Mixed Models Analysis|||||2.8|-0.4|0.1485
71845007|NCT02646618|143203542|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.2480
71676895|NCT02120833|142871954|SUPERIORITY_OR_OTHER|||||||0.0049|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0049
71676896|NCT02120833|142871954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|STANDARD_ERROR_OF_MEAN|4.71||0.2409|TWO_SIDED|95.0|-3.88|15.07||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.07|-3.88|0.2409
71676897|NCT02120833|142871955|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71812549|NCT00279201|143127619|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value is for Baseline at Week 0.|ANOVA|ANOVA used with treatment, country, TZD use and Sulfo use in the model.||||||0.204
71676898|NCT02120833|142871955|SUPERIORITY_OR_OTHER|||||||0.2386|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.2386
71676899|NCT02120833|142871955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.3|STANDARD_ERROR_OF_MEAN|3.98||0.0241|TWO_SIDED|95.0|1.28|17.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.32|1.28|0.0241
71676900|NCT02120833|142871956|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71812550|NCT00279201|143127619|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-Value is for Change from baseline to endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.017
71812551|NCT00279201|143127619|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is for Change Week 24 to Week 120 endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.||||||0.020
71812552|NCT00279201|143127620|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.036
71812553|NCT00279201|143127621|SUPERIORITY_OR_OTHER|||||||0.708||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.708
71845008|NCT02646618|143203547|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|93.0||||0.2025|TWO_SIDED|95.0|-50.0|237.0|||Mixed Models Analysis|||||237|-50|0.2025
71895979|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.03|1.31|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.31|1.03|
71676901|NCT02120833|142871956|SUPERIORITY_OR_OTHER|||||||0.0696|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0696
71812554|NCT00279201|143127622|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.||||||0.028
71676902|NCT02120833|142871956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|4.23||0.0394|TWO_SIDED|95.0|0.46|17.52||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||17.52|0.46|0.0394
71676903|NCT02120833|142871957|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71676904|NCT02120833|142871957|SUPERIORITY_OR_OTHER|||||||0.0772|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0772
71812555|NCT00279201|143127623|SUPERIORITY_OR_OTHER|||||||0.738||95.0|||||Cochran-Mantel-Haenszel|Stratified by country, TZD use, and sulfo use.||||||0.738
71812556|NCT00279201|143127624|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||<0.001
71812557|NCT00279201|143127625|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.043
71812558|NCT00279201|143127626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||<0.001
71812559|NCT00279201|143127627|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.||||||0.032
71812560|NCT00279201|143127628|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.037
71845009|NCT02646618|143203548|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in energy (kcal/day) intake, the study is powered at 90% to detect whether the Get Social condition is not inferior to the Traditional condition with a noninferiority margin of 182 kcal/day (SD=500 kcal/day)|Mean Difference (Net)|-75.0||||0.3323|TWO_SIDED|95.0|-226.0|77.0|||Mixed Models Analysis|||||77|-226|0.3323
71676905|NCT02120833|142871957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48|STANDARD_ERROR_OF_MEAN|3.54||0.0213|TWO_SIDED|95.0|1.33|15.63||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||15.63|1.33|0.0213
71676906|NCT02120833|142871958|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71676907|NCT02120833|142871958|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0172
71676908|NCT02120833|142871958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.56|STANDARD_ERROR_OF_MEAN|3.48||0.1968|TWO_SIDED|95.0|-2.46|11.58||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||11.58|-2.46|0.1968
71676909|NCT02120833|142871959|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||<0.0001
71676910|NCT02120833|142871959|SUPERIORITY_OR_OTHER|||||||0.0712|TWO_SIDED|||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.||||0.0712
71812561|NCT00279201|143127628|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.025
71812562|NCT00279201|143127628|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.132
71812563|NCT00279201|143127628|SUPERIORITY_OR_OTHER|||||||0.849||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.849
71812564|NCT00279201|143127629|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value is for Sulfonylurea/TZD|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.006
71845010|NCT02646618|143203550|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.3905|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.3905
71895980|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.2|||||TWO_SIDED|95.0|1.07|1.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.37|1.07|
71812565|NCT00279201|143127629|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.048
71812566|NCT00279201|143127629|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.258
71895981|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.6|2.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.68|1.60|
71676911|NCT02120833|142871959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43|STANDARD_ERROR_OF_MEAN|3.34||0.0313|TWO_SIDED|95.0|0.7|14.15||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||14.15|0.70|0.0313
71676912|NCT02805179|142872020|SUPERIORITY|Compared to historical controls||||||0.03|||||||1-sided binomial test|||||||0.03
71676913|NCT00305084|142872028|OTHER||MDT|1.6|||||TWO_SIDED|||||||||All data regarding safety were registered and analyzed by descriptive analyses. Summary table were generated to document the safety|at least 3 patients per cohort had to be enrolled with expansion to 6 in presence of Dose Limiting Toxicity(DLT) (stop escalation if 2 or more DLTs at the same dose level). With a projection to achieve the highest level of NGR-hTNF, without significative toxicity (1.6 μg/m2) a planned sample of 20-25 patients was expected. DLTs were defined as: any severe toxicity clearly related to the administration of NGR-hTNF. The patient was defined assessable, according to the standard analysis, if he/she received at least one infusion of the investigational product. Maximal Tollerated Dose (MTD) was defined as the dose which produces DLTs in 2 or more patients out of 6 and will be recommended for phase II trials.|||
71812567|NCT00279201|143127629|SUPERIORITY_OR_OTHER|||||||0.848||95.0||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.||||||0.848
71812568|NCT00279201|143127630|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.004
71812569|NCT00279201|143127631|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.553
71812570|NCT00279201|143127632|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||P-value is for Mean of all post meals blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.010
71812571|NCT00279201|143127632|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value is for Average of all blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.035
71676914|NCT02235077|142872079|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5688|TWO_SIDED|95.0|-0.11|0.2|||Regression, Linear|||||0.20|-0.11|0.5688
71676915|NCT02235077|142872080|SUPERIORITY||Mean Difference (Final Values)|0.25||||0.4155|TWO_SIDED|95.0|-0.35|0.86|||Regression, Linear|||||0.86|-0.35|0.4155
71895982|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.8|||||TWO_SIDED|95.0|1.55|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.03|1.55|
71895983|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|0.9|||||TWO_SIDED|95.0|0.79|1.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.07|0.79|
71895984|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.53|1.05|
71895985|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.6|||||TWO_SIDED|95.0|1.98|3.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||3.50|1.98|
71895986|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.37|2.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.61|1.37|
71676916|NCT02235077|142872081|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3039|TWO_SIDED|95.0|0.83|1.81|||Chi-squared|||||1.81|0.83|0.3039
71676917|NCT02235077|142872082|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.7673|TWO_SIDED|95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.7673
71676918|NCT02235077|142872083|SUPERIORITY||Mean Difference (Final Values)|319.2||||0.5734|TWO_SIDED|95.0|-797.4|1435.8|||Regression, Linear|||||1435.8|-797.4|0.5734
71895987|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.6|||||TWO_SIDED|95.0|1.33|1.86|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.86|1.33|
71676919|NCT02235077|142872084|SUPERIORITY||Mean Difference (Final Values)|-1.02||||0.3528|TWO_SIDED|95.0|-3.05|1.01|||Regression, Linear|||||1.01|-3.05|0.3528
71676920|NCT02235077|142872085|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.0846|TWO_SIDED|95.0|-0.02|0.25|||Regression, Linear|||||0.25|-0.02|0.0846
71895988|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.1|1.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.42|1.10|
71895989|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.14|1.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||1.43|1.14|
71895990|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.2|||||TWO_SIDED|95.0|1.8|2.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.60|1.80|
71895991|NCT01025336|143313936|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.7|||||TWO_SIDED|95.0|1.44|2.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.||2.06|1.44|
71676921|NCT02235077|142872086|SUPERIORITY||Mean Difference (Final Values)|-12.17||||0.0842|TWO_SIDED|95.0|-25.98|1.65|||Regression, Linear|||||1.65|-25.98|0.0842
71676922|NCT02235077|142872087|SUPERIORITY||Odds Ratio (OR)|1.11||||0.7628|TWO_SIDED|95.0|0.56|2.23|||Regression, Logistic|||||2.23|0.56|0.7628
71676923|NCT02235077|142872088|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.6102|TWO_SIDED|95.0|-5.02|2.95|||Regression, Linear|||||2.95|-5.02|0.6102
71676924|NCT02235077|142872089|SUPERIORITY||Odds Ratio (OR)|0.76||||0.5818|TWO_SIDED|95.0|0.29|1.99|||Regression, Logistic|||||1.99|0.29|0.5818
71676925|NCT01672710|142872123|SUPERIORITY||Mean Difference (Net)|6.9|||<|0.05|TWO_SIDED|95.0|-0.3|14.2|||ANCOVA|||||14.2|-0.3|<0.05
71676926|NCT02122887|142872130|OTHER|χ² (1) =4.57, Cramer's V=.24|||||<|0.05|||||||Chi-squared|||we hypothesised that following intervention, those undergoing intervention will be more likely to see justice on both sides, compared to control group||||<0.05
71676927|NCT02122887|142872131|EQUIVALENCE|we compared participants levels of tension (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.65|||>|0.05|TWO_SIDED|95.0|||||ANOVA|df=1||||||>0.05
71676928|NCT02122887|142872132|EQUIVALENCE|we compared participants levels of empathy (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.04|||>|0.05|TWO_SIDED|95.0|||||ANOVA|||||||>0.05
71676929|NCT01729338|142872154|SUPERIORITY_OR_OTHER|||||||0.45||||||Compared baseline to 3 months|paired t-test|||||||0.45
71812572|NCT00279201|143127633|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean of post-meals blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.516
71895992|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.64|0.87|
71676930|NCT01729338|142872154|SUPERIORITY_OR_OTHER|||||||0.19|||||||paired t-test|compares baseline to month 5||||||0.19
71676931|NCT01729338|142872155|SUPERIORITY_OR_OTHER|||||||0.1||||||baseline, 3 month|paired t-test|||||||0.1
71812573|NCT00279201|143127633|SUPERIORITY_OR_OTHER|||||||0.425||95.0||||P-value is for Average of all blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.||||||0.425
71812574|NCT00279201|143127634|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
71812575|NCT00279201|143127634|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
71812576|NCT00279201|143127634|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
71812577|NCT00279201|143127634|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
71812578|NCT00279201|143127635|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.027
71812579|NCT00279201|143127635|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||0.021
71812580|NCT00279201|143127635|SUPERIORITY_OR_OTHER|||||||0.799||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||0.799
71812581|NCT00279201|143127635|SUPERIORITY_OR_OTHER|||||||0.676||95.0||||P-value is for \<=7.0%.|Fisher Exact|||||||0.676
71812582|NCT00279201|143127635|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<7.0%.|Fisher Exact|||||||1.000
71812583|NCT00279201|143127635|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for \<=6.5%.|Fisher Exact|||||||1.000
71812584|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.241
71676932|NCT01729338|142872155|SUPERIORITY_OR_OTHER|||||||0.09|||||||paired t-test|baseline, month 5||||||0.09
71676933|NCT03233529|142872161|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.1|-1.7|||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.7|-3.1|<0.0001
71676934|NCT03233529|142872162|SUPERIORITY||Least Squares Mean Difference|-0.9906|STANDARD_ERROR_OF_MEAN|0.48404||0.042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0420
71676935|NCT03233529|142872163|SUPERIORITY||Least Squares Mean Difference|-0.5446|STANDARD_ERROR_OF_MEAN|0.37855||0.1519|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.1519
71676936|NCT03233529|142872164|SUPERIORITY||Least Squares Mean Difference|-1.1273|STANDARD_ERROR_OF_MEAN|0.32552||0.0007|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0007
71812585|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.305||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.305
71812586|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.842||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.842
71812587|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.917
71812588|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.648||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.648
71812589|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.613||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.613
71812590|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.813
71812591|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.953
71812592|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.933
71812593|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.348||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.348
71812594|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.625||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.625
71812595|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.573||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.573
71812596|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.711||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.711
71812597|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.372||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.372
71812598|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.516
71812599|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.639||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.639
71812600|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.131||95.0||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.131
71812601|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.53||95.0||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.530
71812602|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.578||95.0||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.578
71812603|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.004
71812604|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.951||95.0||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.951
71812605|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.580
71812606|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.071
71845011|NCT02646618|143203551|NON_INFERIORITY|For secondary noninferiority outcomes, we used 90% power to calculate noninferiority margins given N=131 per arm, setting alpha=.05 and using observed SDs from the literature. For change in moderate to vigorous intensity physical activity minutes per day at 12 months, the noninferiority margin is 9.2 min/day(SD=25 min/day). However, we could not analyze the data in that manner and used the test described above.||||||0.4741|||||||Generalized estimating equation|||We examined the proportion of participants engaging in 150+ minutes/week of moderate/vigorous intensity physical activity (MVPA) using generalized estimating equations with a logit link function and incorporating repeated measures over time. For participants missing MVPA at either follow-up timepoint, we used a baseline observation carried forward approach to impute their activity level (150+ vs \<150 MVPA mins/week) at that timepoint.||||0.4741
71845012|NCT04035447|143203590|SUPERIORITY|||||||0.519|||||||t-test, 2 sided|||Satisfaction with Therapy (ST)||||0.519
71845013|NCT04035447|143203590|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||Satisfaction with Therapist (SWT)||||0.150
71845014|NCT04035447|143203590|SUPERIORITY|||||||0.309|||||||t-test, 2 sided|||Global Improvement (Item 13)||||0.309
71845015|NCT04035447|143203592|SUPERIORITY|||||||0.696|||||||t-test, 2 sided|||||||0.696
71845016|NCT04035447|143203593|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
71845017|NCT04035447|143203594|SUPERIORITY|||||||0.274|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.274
71845018|NCT04035447|143203595|SUPERIORITY|||||||0.6|||||||Fisher Exact|||Outcomes were compared at post-intervention visit: 3-month (A2) for intervention participants, 9-month (A4) for waitlist control participants.||||0.600
71676937|NCT03233529|142872165|SUPERIORITY||Least Squares Mean Difference|-0.7612|STANDARD_ERROR_OF_MEAN|0.44266||0.0871|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0871
71812607|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.081
71845019|NCT04035447|143203596|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_DEVIATION|8.4||0.1848|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.1848
71845020|NCT04035447|143203597|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|8.4||0.6153|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.07||||||0.6153
71812608|NCT00279201|143127636|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||<0.001
71812609|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.542||95.0||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.542
71812610|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.003
71812611|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.105
71812612|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.487||95.0||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.487
71812613|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.491||95.0||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.491
71812614|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.127
71812615|NCT00279201|143127636|SUPERIORITY_OR_OTHER|||||||0.861||95.0||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.861
71845021|NCT04035447|143203598|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_DEVIATION|16.1||0.0563|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.28||||||0.0563
71845022|NCT04035447|143203599|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.8||0.0265|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.31||||||0.0265
71845023|NCT04035447|143203599|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_DEVIATION|2.6||0.2084|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of 0.18||||||0.2084
71845024|NCT04035447|143203600|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|9.4||0.3512|||||||Wilcoxon (Mann-Whitney)|Effect size (Hedges' g) of -0.13||||||0.3512
71845025|NCT02397096|143203642|NON_INFERIORITY|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-3.784|||||TWO_SIDED|95.0|-7.877|0.31|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|0.310|-7.877|
71845026|NCT02397096|143203643|OTHER||Treatment Difference|-14.65|||<|0.0001|TWO_SIDED|95.0|-18.92|-10.38|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-10.38|-18.92|<0.0001
71845027|NCT02397096|143203644|OTHER||Treatment Difference|-23.03|||<|0.0001|TWO_SIDED|95.0|-28.0|-18.05|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.|||-18.05|-28.00|<0.0001
71812616|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.745
71812617|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.467
71895993|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.63|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.08|0.63|
71895994|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.25|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.80|1.25|
71895995|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.71|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.53|0.71|
71895996|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|7.3|||||TWO_SIDED|95.0|4.67|11.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||11.44|4.67|
71895997|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|2.6|||||TWO_SIDED|95.0|1.61|4.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.17|1.61|
71895998|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|2.0|||||TWO_SIDED|95.0|1.22|3.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||3.29|1.22|
71895999|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|0.96|2.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.77|0.96|
71676938|NCT03233529|142872166|SUPERIORITY||Least Squares Mean Difference|-1.3641|STANDARD_ERROR_OF_MEAN|0.48603||0.0055|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0055
71812618|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
71812619|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
71896000|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.54|1.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.28|0.54|
71896001|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||2.07|0.92|
71896002|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|1.01|1.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.83|1.01|
71896003|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|1.2|||||TWO_SIDED|95.0|0.77|1.78|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||1.78|0.77|
71896004|NCT01025336|143313937|SUPERIORITY_OR_OTHER||Ratio|3.0|||||TWO_SIDED|95.0|1.97|4.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.||4.64|1.97|
71896005|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.15|2.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.15|1.15|
71676939|NCT03233529|142872167|SUPERIORITY||Least Squares Mean Difference|-1.1246|STANDARD_ERROR_OF_MEAN|0.49359||0.0238|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0238
71812620|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
71812621|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
71812622|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
71812623|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
71812624|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
71845028|NCT02397096|143203645|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-0.877|||||TWO_SIDED|95.0|-4.706|2.952|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).|2.952|-4.706|
71845029|NCT02397096|143203646|OTHER||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-31.6|23.5|||||95% CIs were calculated based on t-distribution.|||23.5|-31.6|
71845030|NCT02397096|143203647|SUPERIORITY||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-41.1|15.4|||||95% Confidence Intervals were based on t-distribution.|||15.4|-41.1|
71845031|NCT02397096|143203648|OTHER||Treatment Difference|-3.556|||||TWO_SIDED|95.0|-7.977|0.864|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||0.864|-7.977|
71845032|NCT02397096|143203649|OTHER||Treatment Difference|-0.427|||||TWO_SIDED|95.0|-4.591|3.738|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||3.738|-4.591|
71845033|NCT02397096|143203650|NON_INFERIORITY|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.|Treatment Difference|-0.232|||||TWO_SIDED|95.0|-2.529|2.064|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||2.064|-2.529|
71845034|NCT05580003|143203662|OTHER||Ratio of Adjusted Geometric Means|101.29|||||TWO_SIDED|90.0|95.71|107.18|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||107.18|95.71|
71676940|NCT03233529|142872168|SUPERIORITY||Least Squares Mean Difference|-1.9913|STANDARD_ERROR_OF_MEAN|0.68659||0.0042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||||0.0042
71812625|NCT00279201|143127637|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
71812626|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.467||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.467
71812627|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.575||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.575
71812628|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.726||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.726
71812629|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.978
71812630|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.345||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.345
71812631|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.||||||0.745
71812632|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.166
71812633|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.064
71812634|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.199||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.199
71812635|NCT00279201|143127638|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.098
71812636|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.837
71845035|NCT05580003|143203662|OTHER||Ratio of Adjusted Geometric Means|102.74|||||TWO_SIDED|90.0|97.28|108.5|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUCinf||108.50|97.28|
71845036|NCT05580003|143203662|OTHER||Ratio of Adjusted Geometric Means|97.83|||||TWO_SIDED|90.0|91.32|104.8|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||104.80|91.32|
71812637|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.205
71812638|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.704||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.704
71812639|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.610
71812640|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.352
71812641|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.636||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.636
71845037|NCT05580003|143203662|OTHER||Ratio of Adjusted Geometric Means|102.41|||||TWO_SIDED|90.0|95.6|109.7|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|AUClast||109.70|95.60|
71896006|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.76|1.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.32|0.76|
71896007|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.8|||||TWO_SIDED|95.0|1.09|3.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.05|1.09|
71812642|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.880
71812643|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.904||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.904
71812644|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.859
71812645|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.654
71812646|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.566
71812647|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.926||95.0||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.926
71812648|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.902
71812649|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.766||95.0||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.766
71812650|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.449||95.0||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.449
71812651|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.797||95.0||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.797
71812652|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.438
71812653|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.602||95.0||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.602
71812654|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.493||95.0||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.493
71812655|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.335||95.0||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.335
71812656|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.398||95.0||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.398
71812657|NCT00279201|143127639|SUPERIORITY_OR_OTHER|||||||0.903||95.0||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.||||||0.903
71812658|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Hypoglycemia episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
71845038|NCT05580003|143203663|OTHER||Ratio of Adjusted Geometric Means|67.18|||||TWO_SIDED|90.0|58.13|77.65|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||77.65|58.13|
71845039|NCT05580003|143203663|OTHER||Ratio of Adjusted Geometric Means|74.12|||||TWO_SIDED|90.0|64.14|85.67|||||A mixed effect model was used with sequence, period and treatment as fixed effect and participant nested within sequence as random effect. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages.|||85.67|64.14|
71896008|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.95|1.96|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.96|0.95|
71896009|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|4.8|||||TWO_SIDED|95.0|3.05|7.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||7.50|3.05|
71896010|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|2.3|||||TWO_SIDED|95.0|1.4|3.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||3.64|1.40|
71896011|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.0|||||TWO_SIDED|95.0|0.58|1.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.62|0.58|
71896012|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.4|||||TWO_SIDED|95.0|0.83|2.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.32|0.83|
71676941|NCT03233529|142872175|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-2.7|-1.4|||Mixed Models Analysis|||Crisaborole 2% was superior to vehicle if p-value was \<0.05.||-1.4|-2.7|< 0.0001
71676942|NCT03233529|142872176|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.3|-0.6|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-1.3|< 0.0001
71676943|NCT03233529|142872176|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-1.4|< 0.0001
71812659|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.953||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.953
71812660|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.188
71845040|NCT05580003|143203699|OTHER||Ratio of Adjusted Geometric Means|72.87|||||TWO_SIDED|90.0|60.98|87.09|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||87.09|60.98|
71845041|NCT05580003|143203699|OTHER||Ratio of Adjusted Geometric Means|76.45|||||TWO_SIDED|90.0|68.35|85.52|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUCinf||85.52|68.35|
71896013|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|0.9|||||TWO_SIDED|95.0|0.58|1.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||1.40|0.58|
71896014|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.6|||||TWO_SIDED|95.0|1.09|2.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.41|1.09|
71812661|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.226
71812662|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.855||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.855
71812663|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.25||95.0||||P-value is for Hypoglycemia episodes at endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.250
71896015|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.5|||||TWO_SIDED|95.0|1.1|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.03|1.10|
71896016|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.3|||||TWO_SIDED|95.0|0.89|2.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.02|0.89|
71812664|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.123
71812665|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.166||95.0||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.166
71812666|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.273
71812667|NCT00279201|143127640|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.||||||0.039
71812668|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.623
71812669|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Hypoglycemic episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
71812670|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.730
71812671|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.445
71812672|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.949||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.949
71812673|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.590
71812674|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.657||95.0||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.657
71812675|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.108||95.0||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.108
71812676|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.161||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.161
71812677|NCT00279201|143127641|SUPERIORITY_OR_OTHER|||||||0.178||95.0||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.||||||0.178
71812678|NCT00279201|143127642|SUPERIORITY_OR_OTHER|||||||0.917||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.917
71812679|NCT00279201|143127642|SUPERIORITY_OR_OTHER|||||||0.754||95.0||||P-value for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.754
71812680|NCT00279201|143127642|SUPERIORITY_OR_OTHER|||||||0.42||95.0||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.420
71812681|NCT00279201|143127642|SUPERIORITY_OR_OTHER|||||||0.514||95.0||||P-value for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.||||||0.514
71845042|NCT05580003|143203699|OTHER||Ratio of Adjusted Geometric Means|73.52|||||TWO_SIDED|90.0|65.7|82.27|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||82.27|65.70|
71812682|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.770
71812683|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.566
71812684|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.812||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.812
71812685|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.99||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.990
71812686|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.552||95.0||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.||||||0.552
71812687|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.179
71812688|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.377||95.0||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.377
71812689|NCT00279201|143127643|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.||||||0.271
71812690|NCT00316173|143127646|SUPERIORITY_OR_OTHER||Percentage of participants with CR+PR|30.9||||||95.0|18.7|43.1||||||||43.1|18.7|
71812691|NCT00511875|143127665|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
71812692|NCT00511875|143127666|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Foveal Sensitivity||||.33
71812693|NCT00511875|143127666|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||Mean field sensitivity||||.16
71812694|NCT00511875|143127667|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Foveal Sensitivity||||.02
71812695|NCT00511875|143127667|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||mean FDP sensitivity||||.3
71812696|NCT00511875|143127668|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||||||.98
71812697|NCT00511875|143127669|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||.46
71812698|NCT00511875|143127670|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||||||.81
71812699|NCT00511875|143127671|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
71812700|NCT00511875|143127672|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
71812701|NCT00511875|143127673|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||.62
71812702|NCT01349920|143127684|SUPERIORITY_OR_OTHER|||||||0.071|||||||Multiple Linear Regression|||Week 6||||0.071
71812703|NCT01349920|143127684|SUPERIORITY_OR_OTHER|||||||0.381|||||||Multiple Linear Regression|||Week 22||||0.381
71812704|NCT00696384|143127703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-9.78|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-5.78|-9.78|<0.001
71812705|NCT00696384|143127704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.47|-9.29||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA|||||-9.29|-15.47|<0.001
71676944|NCT03233529|142872177|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36||0.0188|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis||Comparison at Day 2|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.1|-1.6|0.0188
71845043|NCT05580003|143203699|OTHER||Ratio of Adjusted Geometric Means|75.16|||||TWO_SIDED|90.0|66.36|85.13|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|AUClast||85.13|66.36|
71845044|NCT05580003|143203700|OTHER||Ratio of Adjusted Geometric Means|76.72|||||TWO_SIDED|90.0|60.21|97.75|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||97.75|60.21|
71845045|NCT05580003|143203700|OTHER||Ratio of Adjusted Geometric Means|70.92|||||TWO_SIDED|90.0|53.7|93.67|||||A paired t-test was used. Values had been back-transformed from natural log scale. Ratios (and 90% CIs) were expressed as percentages|||93.67|53.70|
71845046|NCT02130557|143203741|SUPERIORITY||Odds Ratio (OR)|1.547||||0.01|TWO_SIDED|95.0|1.072|2.233||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.025.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|A total sample size of 500 Ph+ participants is required for the study to provide \>= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O'Brien-Fleming analog beta spending function).||2.233|1.072|0.0100
71845047|NCT02130557|143203742|SUPERIORITY||Odds Ratio (OR)|1.418||||0.0303|TWO_SIDED|95.0|0.986|2.037||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.037|0.986|0.0303
71845048|NCT02130557|143203743|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.49|2.44|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||2.44|0.49|
71845049|NCT02130557|143203744|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0037|TWO_SIDED|95.0|1.16|2.61||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group (low, intermediate, high) and region (1-3) at time of randomization. Statistical significance threshold: 1-sided 0.0125.|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.|If the primary analysis was significant, each member of the short-term family (CCyR by Month 12, MMR by Month 18) was tested via Bonferroni's procedure at the 1-sided level of 0.0125.||2.610|1.160|0.0037
71845050|NCT02130557|143203745|SUPERIORITY||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.14|1.13|||||Hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|The medians have not been reached in either arm, as such, the premature estimated hazard ratio is provided.||1.13|0.14|
71845051|NCT02130557|143203746|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0749|TWO_SIDED|95.0|0.35|1.17||1-sided p-value based on Gray's test for comparing cumulative incidence function between treatment arms stratified by sokal risk group (low, intermediate, high) and region (1-3). Statistical significance threshold: 1-sided 0.0125.|Gray's test||The hazard ratio (95% CIs) are based on the proportional subdistribution hazards model stratified by Sokal risk group and region.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.17|0.35|0.0749
71896017|NCT01025336|143313938|SUPERIORITY_OR_OTHER||Ratio|1.9|||||TWO_SIDED|95.0|1.27|2.97|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures \[(13vPnC - 23vPS)\].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale||2.97|1.27|
71676945|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0014|TWO_SIDED|95.0|-1.9|-0.4|||Mixed Models Analysis||Comparison at Day 3|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.4|-1.9|0.0014
71676946|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 4|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
71896018|NCT01184989|143313965|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|102.16|STANDARD_DEVIATION|22.8||||90.0|97.64|106.893|||Geometric Mean||Dispersion value is actually the intraindividual gCV.|Estimated local measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 136 quantifiable measurements.||106.893|97.640|
71896019|NCT01184989|143313966|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability analysis|Ratio|92.37|STANDARD_DEVIATION|23.5||||90.0|90.079|94.719|||Geometric Mean||The Dispersion Value is actually the intraindividual gCV.|Estimated central measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 468 quantifiable measurements.||94.719|90.079|
71896020|NCT01570491|143313968|SUPERIORITY_OR_OTHER|||||||0.83|||||||Kruskal-Wallis|||"We hypothesized that real-time US guidance would result in a 20% lower number of attempts compared to the control group.~At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group, therefore we planned to recruit 40 patients in total."||||0.83
71896021|NCT01570491|143313969|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71676947|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis||Comparison at Day 5|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.2|< 0.0001
71812706|NCT00811382|143127757|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71812707|NCT00685945|143127769|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||The effect of bradykinin on net t-PA release was determined using general linear model-repeated measures ANOVA in which the between-subject variable was gender, and the within-subjects variables were drug (control, +L-NMMA, +L-NMMA plus isosorbide, or +L-NMMA plus sildenafil) and dose of bradykinin.||||0.04
71845052|NCT02130557|143203747|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.2827|TWO_SIDED|95.0|0.37|1.73||1-sided p-value based on log-rank test for comparing survival curves between treatment arms stratified by sokal risk group and region. OS was not tested as EFS was not significant.|Log Rank||The hazard ratio (95% CIs) are based on the treatment effect (Bosutinib compared with Imatinib) in a stratified (by Sokal risk group at randomization and region) Cox proportional hazards model for the hazard of the respective event.|If each member of the short-term family (CCyR by Month 12, MMR by Month 18) was significant, EFS and OS were tested sequentially via the Holm's testing procedure at the 1-sided family wise level of 0.025. If one member of the short-term family was significant, EFS and OS were tested sequentially at 1-sided 0.0125.||1.73|0.37|0.2827
71845053|NCT03333109|143203768|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.34||0.002|TWO_SIDED|95.0|-1.77|-0.42|||Mixed Models Analysis|||||-0.42|-1.77|0.002
71845054|NCT03333109|143203768|SUPERIORITY||Median Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.45|-0.93|||Mixed Models Analysis|||||-0.93|-2.45|<0.001
71845055|NCT03333109|143203769|SUPERIORITY||Odds Ratio (OR)|1.52||||0.007|TWO_SIDED|95.0|1.12|2.07|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||2.07|1.12|0.007
71845056|NCT03333109|143203769|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.55|3.15|||Cochran-Mantel-Haenszel|Haenszel (CMH) test adjusted for stratification factor after missing data were imputed as non-response (NRI).||||3.15|1.55|<0.001
71845057|NCT03333109|143203770|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.07|-0.64|||Mixed Models Analysis|||||-0.64|-2.07|<0.001
71845058|NCT03333109|143203770|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.71|-1.09|||Mixed Models Analysis|||||-1.09|-2.71|<0.001
71845059|NCT03333109|143203771|SUPERIORITY||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.62||0.004|TWO_SIDED|95.0|-2.99|-0.56|||Mixed Models Analysis|||||-0.56|-2.99|0.004
71845060|NCT03333109|143203771|SUPERIORITY||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-4.07|-1.36|||Mixed Models Analysis|||||-1.36|-4.07|<0.001
71845061|NCT01447706|143203792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.007|TWO_SIDED|95.0|0.18|0.76|||Log Rank|||||0.76|0.18|0.007
71845062|NCT01447706|143203792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.023|TWO_SIDED|95.0|1.08|2.98|||Log Rank|||||2.98|1.08|0.023
71845063|NCT00918203|143203793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.2133|TWO_SIDED|95.0|0.86|1.93|||Log Rank|||||1.93|0.86|0.2133
71812708|NCT00685945|143127770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Repeated measures ANOVA||||||<0.001
71845064|NCT00918203|143203796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8731|TWO_SIDED|95.0|0.68|1.57|||Log Rank|||||1.57|0.68|0.8731
71812709|NCT03183388|143127772|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare Least Square (LS) estimate of endpoint minus baseline to zero. The best-fitting model was chosen based on information criteria.|Endpoint minus Baseline|-3.04|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-4.14|-1.93|||t-test, 2 sided|||||-1.93|-4.14|0.0001
71812710|NCT03183388|143127773|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|-1.37|STANDARD_ERROR_OF_MEAN|2.51||0.6|TWO_SIDED|95.0|-6.97|4.23|||t-test, 2 sided|||||4.23|-6.97|0.60
71845065|NCT00918203|143203797|SUPERIORITY_OR_OTHER|||||||0.4721|||||||Fisher Exact|||||||0.4721
71845066|NCT00490139|143203864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.048|TWO_SIDED|95.0|0.71|1.0|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.00|0.71|0.048
71845067|NCT00490139|143203864|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.61|TWO_SIDED|95.0|0.81|1.13|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.13|0.81|0.610
71845068|NCT00490139|143203865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.887|||||TWO_SIDED|95.0|0.77|1.02|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.02|0.77|
71845069|NCT00490139|143203865|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.914|||||TWO_SIDED|95.0|0.8|1.05|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.05|0.80|
71845070|NCT00490139|143203866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.078|TWO_SIDED|95.0|0.62|1.03|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.62|0.078
71896022|NCT01570491|143313970|SUPERIORITY|||||||0.09|||||||Kruskal-Wallis|||||||0.09
71896023|NCT01570491|143313971|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||||||0.06
71896024|NCT01015443|143313980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.032||||0.921|TWO_SIDED|95.0|0.552|1.931|||Adjusted log rank|||||1.931|0.552|0.921
71812711|NCT03183388|143127774|OTHER|Mixed model with time (baseline and endpoint) as within-subjects factor; compare LS estimate of endpoint minus baseline to zero.|Endpoint minus Baseline|0.11|STANDARD_ERROR_OF_MEAN|0.016||0.0001|TWO_SIDED|95.0|0.074|0.146|||t-test, 2 sided|||||0.146|0.074|0.0001
71812712|NCT03183388|143127775|OTHER|Mixed model with time (baseline and midpoint) as within-subjects factor; compare LS estimate of midpoint minus baseline to zero.|Midpoint minus Baseline|0.031|STANDARD_ERROR_OF_MEAN|0.055||0.58|TWO_SIDED|95.0|-0.095|0.157|||t-test, 2 sided|||||0.157|-0.095|0.58
71845071|NCT00490139|143203866|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.433|TWO_SIDED|95.0|0.71|1.16|||Log Rank|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.16|0.71|0.433
71845072|NCT00490139|143203867|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.853|||||TWO_SIDED|95.0|0.7|1.03|||||The estimate of the treatment hazard ratio (lap plus tras versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.03|0.70|
71845073|NCT00490139|143203867|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.863|||||TWO_SIDED|95.0|0.71|1.04|||||The estimate of the treatment hazard ratio (tras followed by lap versus tras) was based on the Cox proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and axillary lymph node status.|||1.04|0.71|
71845074|NCT00490139|143203868|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.811|||||TWO_SIDED|95.0|0.68|0.96||||||||0.96|0.68|
71845075|NCT00490139|143203868|SUPERIORITY_OR_OTHER_LEGACY|Time to recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.1||||||||1.10|0.79|
71845076|NCT00490139|143203869|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.852|||||TWO_SIDED|95.0|0.71|1.02||||||||1.02|0.71|
71845077|NCT00490139|143203869|SUPERIORITY_OR_OTHER_LEGACY|Time to distant recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.968|||||TWO_SIDED|95.0|0.81|1.16||||||||1.16|0.81|
71845078|NCT00490139|143203870|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.986|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
71896025|NCT01515072|143313986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.38|TWO_SIDED|95.0|-0.37|0.21||This is an unadjusted comparison. P value \< 0.05|t-test, 2 sided|Adjusted analyses for the RIPC effect are provided below.|0.08 less organs per donor in the RIPC group.|Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.21|-0.37|0.38
71896026|NCT01515072|143313987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.33|0.26||This is an unadjusted analysis. P \< 0.05|t-test, 2 sided|Adjusted analyses are provided below.|0.03 less organs per donor in the RIPC group.|Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.||0.26|-0.33|0.70
71676948|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.36||0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 6|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.6|-2.0|0.0003
71896027|NCT01515072|143313988|SUPERIORITY_OR_OTHER|||||||0.63||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.63
71845079|NCT00490139|143203870|SUPERIORITY_OR_OTHER_LEGACY|Time to CNS recurrence was analyzed using competing risks methodology with death (without event) as a competing risk.|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.74|1.31||||||||1.31|0.74|
71845080|NCT04484623|143203873|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.73||P-Value presented to 3 decimal places from one-sided stratified Log-Rank test adjusting for the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata.|Log Rank||Hazard ratio was estimated using a Cox Proportional Hazards model stratified by the number of lines of prior therapy (1 vs. 2/3 vs. \>=4) and prior bortezomib (yes or no) according to IVRS strata with a covariate of treatment.|||0.73|0.37|<0.001
71845081|NCT04701203|143203929|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||For the primary efficacy endpoint, the Cochran-Mantel Haenszel test stratified by etiology of hypoparathyroidism (postsurgical or other) was used to compare the proportion of participants meeting the composite primary endpoint in the TransCon PTH versus placebo groups. Participants without week 26 albumin-adjusted serum calcium or with \>25% (ie, \>7 days) missing diary data of active vitamin D or elemental calcium during the 4 weeks before week 26 were considered non-responders.||||<0.0001
71845082|NCT04701203|143203930|SUPERIORITY||||||=|0.0038|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0038
71845083|NCT04701203|143203931|SUPERIORITY||||||=|0.0055|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0055
71896028|NCT01515072|143313989|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
71896029|NCT01515072|143313990|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
71812713|NCT00847405|143127776|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.64||||||90.0|95.93|111.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111.97|95.93|
71812714|NCT00847405|143127777|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.81||||||90.0|97.95|107.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.91|97.95|
71896030|NCT01515072|143313991|SUPERIORITY_OR_OTHER|||||||0.55||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.55
71812715|NCT00847405|143127778|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.25||||||90.0|98.35|108.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.41|98.35|
71812716|NCT00071721|143127787|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.958||||0.88||95.0|||||Cox Proportional Hazards|||||||0.88
71812717|NCT00949715|143127804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.2352|TWO_SIDED|95.0|-2.7|10.8|||t-test, 2 sided|||HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.||10.8|-2.7|0.2352
71812718|NCT00949715|143127805|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.7405|TWO_SIDED|95.0|-7.6|5.5|||t-test, 2 sided|||Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.||5.5|-7.6|0.7405
71812719|NCT00949715|143127806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3||||0.1051|TWO_SIDED|95.0|-25.1|2.4|||t-test, 2 sided|||Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volume||2.4|-25.1|0.1051
71812720|NCT00949715|143127807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.9||||0.9835||95.0||||Adjusting for age and gender|Wilcoxon (Mann-Whitney)|Rank Sum||Ho: The AT/AF burden in the RVS group is the same as the RVA group.||||0.9835
71812721|NCT03928028|143127809|SUPERIORITY|||||||0.507||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.507
71812722|NCT03928028|143127809|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.017
71812723|NCT03928028|143127809|SUPERIORITY|||||||0.139||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.139
71812724|NCT03928028|143127810|SUPERIORITY|||||||0.389|||||||generalized estimating equation|||This analysis compare mothers in FBT to mothers in FBT+CRTp||||.389
71812725|NCT03928028|143127810|SUPERIORITY|||||||0.447||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.447
71812726|NCT03928028|143127810|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||<.001
71812727|NCT03928028|143127811|SUPERIORITY|||||||0.778||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.778
71812728|NCT03928028|143127811|SUPERIORITY|||||||0.297||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.297
71812729|NCT03928028|143127811|SUPERIORITY|||||||0.062||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.062
71896031|NCT01515072|143313992|SUPERIORITY_OR_OTHER|||||||0.48||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.48
71812730|NCT03928028|143127812|SUPERIORITY|||||||0.069||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.069
71812731|NCT03928028|143127812|SUPERIORITY|||||||0.323||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.323
71812732|NCT03928028|143127812|SUPERIORITY|||||||0.225|||||||generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.225
71812733|NCT03928028|143127813|SUPERIORITY|||||||0.196||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.196
71812734|NCT03928028|143127813|SUPERIORITY|||||||0.812||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.812
71812735|NCT03928028|143127813|SUPERIORITY|||||||0.499||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.499
71812736|NCT03928028|143127814|SUPERIORITY|||||||0.446||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.446
71812737|NCT03928028|143127814|SUPERIORITY|||||||0.647|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.647
71896032|NCT01515072|143313993|SUPERIORITY_OR_OTHER|||||||0.04||||||P\<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison||||||0.04
71896033|NCT01515072|143313994|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.7||||0.53|TWO_SIDED|95.0|-10.1|19.5||P\<0.05|Regression, Linear|Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion|Data shown above is the the adjusted mean difference in final flow in RIPC group|||19.5|-10.1|0.53
71676949|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.3|-0.8|||Mixed Models Analysis||Comparison at Day 7|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.8|-2.3|< 0.0001
71812738|NCT03928028|143127814|SUPERIORITY|||||||0.765||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.765
71812739|NCT03928028|143127815|SUPERIORITY|||||||0.425||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares mothers in FBT to mothers in FBT+Parent-focused CRT||||.425
71845084|NCT04701203|143203932|SUPERIORITY||||||=|0.0046|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0046
71845085|NCT04701203|143203933|SUPERIORITY||||||=|0.0061|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0061
71845086|NCT04701203|143203934|SUPERIORITY||||||=|0.0347|||||||t-test, 2 sided|||ANCOVA model with unequal variance was used to analyze the key secondary Endpoints. The change from baseline is variable of interest at week 26 and was included in the model as response variables. Treatment assignment and etiology of hypoparathyroidism were entered as fixed effects and baseline value of the variable of interest was entered as a covariate.||||= 0.0347
71845087|NCT06140290|143203938|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|108.32|||||TWO_SIDED|90.0|101.2|115.94|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||115.94|101.20|
71845088|NCT06140290|143203939|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|120.41|||||TWO_SIDED|90.0|108.02|134.22|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||134.22|108.02|
71845089|NCT06140290|143203940|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|115.29|||||TWO_SIDED|90.0|105.17|126.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||126.38|105.17|
71845090|NCT06140290|143203941|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the reference treatment, while Etrasimod 2mg (Treatment G) without practice session was the test treatment.|Ratio of Adjusted Geometric Means|106.75|||||TWO_SIDED|90.0|99.33|114.73|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using a mixed effect model, with treatment as a fixed effect and participant as a random effect.||114.73|99.33|
71845091|NCT06140290|143203942|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|91.8|||||TWO_SIDED|90.0|77.76|108.38|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA (Analysis of variance) model with treatment as a fixed effect.||108.38|77.76|
71845092|NCT06140290|143203942|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|86.33|122.19|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||122.19|86.33|
71896034|NCT01515072|143313995|SUPERIORITY_OR_OTHER|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71896035|NCT01515072|143313996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.07|TWO_SIDED|95.0|0.95|2.76||Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.|Chi-squared|||||2.76|0.95|0.07
71676950|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.5|-1.1|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.1|-2.5|< 0.0001
71896036|NCT01515072|143313996|SUPERIORITY_OR_OTHER|||||||0.36||||||Unadjusted analysis|Chi-squared|||||||0.36
71812740|NCT03928028|143127815|SUPERIORITY|||||||0.63|||||||generalized estimating equation|||This analysis compares fathers in FBT to fathers in FBT+Parent-focused CRT||||.630
71812741|NCT03928028|143127815|SUPERIORITY|||||||0.854||||||a priori threshold for statistical significance = .15|generalized estimating equation|||This analysis compares adolescents in FBT to adolescents in FBT+Adolescent-focused CRT||||.854
71676951|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 9|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
71676952|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.3|||Mixed Models Analysis||Comparison at Day 10|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.3|-2.7|< 0.0001
71812742|NCT02802501|143127819|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|0.001|TWO_SIDED|95.0|0.285|0.693|||Cox Proportional Hazard||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.693|0.285|<0.001
71812743|NCT02802501|143127820|SUPERIORITY||Hazard Ratio (HR)|1.722|||||TWO_SIDED|95.0|1.031|2.875|||||If hazard ratio was found to be \>1 then there are higher chances of relapse with Tafenoquine+DHA-PQP compared to Primaquine+DHA-PQP.|||2.875|1.031|
71812744|NCT02802501|143127821|SUPERIORITY||Hazard Ratio (HR)|0.258|||||TWO_SIDED|95.0|0.155|0.431|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Primaquine+DHA-PQP compared to DHA-PQP only.|||0.431|0.155|
71812745|NCT02802501|143127822|SUPERIORITY||Hazard Ratio (HR)|0.433|||||TWO_SIDED|95.0|0.273|0.686|||||If hazard ratio was found to be \<1 then there are lower chances of relapse with Tafenoquine+DHA-PQP compared to DHA-PQP only.|||0.686|0.273|
71812746|NCT04525547|143127843|OTHER|||||||0.817|||||||t-test, 2 sided|||||||0.8170
71812747|NCT04525547|143127844|OTHER|||||||0.6533|||||||t-test, 2 sided|||||||0.6533
71812748|NCT04425902|143127852|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.94|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.94|
71812749|NCT04425902|143127853|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.95|1.32|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.32|0.95|
71812750|NCT04425902|143127854|OTHER||Ratio of geometric least square mean|0.95|||||TWO_SIDED|90.0|0.83|1.08|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.08|0.83|
71812751|NCT04425902|143127857|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
71812752|NCT04425902|143127858|OTHER||Ratio of geometric least square mean|1.23|||||TWO_SIDED|90.0|0.71|2.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||2.14|0.71|
71812753|NCT04425902|143127859|OTHER||Ratio of geometric least square mean|1.11|||||TWO_SIDED|90.0|0.72|1.69|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.69|0.72|
71812754|NCT04425902|143127862|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|0.97|1.2|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.20|0.97|
71812755|NCT04425902|143127863|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|0.98|1.21|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.21|0.98|
71812756|NCT04425902|143127864|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.92|1.17|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.17|0.92|
71812757|NCT04425902|143127867|OTHER||Ratio of geometric least square mean|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.88|
71896037|NCT01515072|143313997|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.006|TWO_SIDED|95.0|0.03|0.17|||Regression, Linear|Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.|Data shown above is the adjusted mean difference in final resistance in the RIPC group.|||0.17|0.03|0.006
71896038|NCT01515072|143313998|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|This is an unadjusted comparison||||||0.50
71896039|NCT01515072|143313999|SUPERIORITY_OR_OTHER|||||||0.03|||||||Log Rank|This is an unadjusted comparison||||||0.03
71812758|NCT04425902|143127868|OTHER||Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.89|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.89|
71812759|NCT04425902|143127869|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.93|1.18|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.18|0.93|
71812760|NCT04425902|143127872|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.72|1.75|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.75|0.72|
71812761|NCT04425902|143127873|OTHER||Ratio of geometric least square mean|0.97|||||TWO_SIDED|90.0|0.54|1.73|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.73|0.54|
71812762|NCT04425902|143127874|OTHER||Ratio of geometric least square mean|1.14|||||TWO_SIDED|90.0|0.73|1.78|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.78|0.73|
71812763|NCT04425902|143127877|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.8|1.11|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.11|0.80|
71812764|NCT04425902|143127878|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.79|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.79|
71845093|NCT06140290|143203943|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|86.34|||||TWO_SIDED|90.0|69.42|107.37|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.37|69.42|
71845094|NCT06140290|143203943|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.98|||||TWO_SIDED|90.0|76.99|124.7|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.70|76.99|
71845095|NCT06140290|143203944|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|88.72|||||TWO_SIDED|90.0|73.1|107.68|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||107.68|73.10|
71845096|NCT06140290|143203944|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|97.54|||||TWO_SIDED|90.0|78.74|120.83|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||120.83|78.74|
71845097|NCT06140290|143203945|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment F) with practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|94.14|||||TWO_SIDED|90.0|79.01|112.17|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||112.17|79.01|
71896040|NCT01515072|143314000|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.19||||0.01|TWO_SIDED|95.0|0.04|0.9|||Log Rank|Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below|The proportional hazard ratio favors RIPC group|||0.90|0.04|0.01
71896041|NCT01515072|143314001|SUPERIORITY_OR_OTHER|||||||0.37|||||||Log Rank|This is an unadjusted comparison||||||0.37
71896042|NCT00609128|143314010|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|ANOVA with preplanned comparisons was used to generate two tailed P values. Paired t tests were used to make appropriate post-ANOVA comparisons.||"tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume."||||<0.05
71896043|NCT00923091|143314014|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
71896044|NCT00923091|143314014|SUPERIORITY_OR_OTHER|||||||0.0323||95.0|||||ANCOVA|||||||0.0323
71896045|NCT00923091|143314014|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|||||||0.0080
71896046|NCT00923091|143314014|SUPERIORITY_OR_OTHER|||||||0.0071||95.0|||||ANCOVA|||||||0.0071
71896047|NCT00923091|143314014|SUPERIORITY_OR_OTHER|||||||0.0107||95.0|||||ANCOVA|||||||0.0107
71896048|NCT00923091|143314015|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71896049|NCT00923091|143314015|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANCOVA|||||||0.0008
71896050|NCT00923091|143314015|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71896051|NCT00923091|143314015|SUPERIORITY_OR_OTHER|||||||0.0034||95.0|||||ANCOVA|||||||0.0034
71896052|NCT00923091|143314015|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71896053|NCT00923091|143314016|SUPERIORITY_OR_OTHER|||||||0.0295||95.0|||||Cochran-Mantel-Haenszel|||||||0.0295
71896054|NCT00923091|143314016|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
71896055|NCT00923091|143314016|SUPERIORITY_OR_OTHER|||||||0.0037||95.0|||||Cochran-Mantel-Haenszel|||||||0.0037
71896056|NCT00923091|143314016|SUPERIORITY_OR_OTHER|||||||0.2033||95.0|||||Cochran-Mantel-Haenszel|||||||0.2033
71896057|NCT00923091|143314016|SUPERIORITY_OR_OTHER|||||||0.2529||95.0|||||Cochran-Mantel-Haenszel|||||||0.2529
71896058|NCT00923091|143314017|SUPERIORITY_OR_OTHER|||||||0.1135||95.0|||||ANCOVA|||||||0.1135
71896059|NCT00923091|143314018|SUPERIORITY_OR_OTHER|||||||0.2765||95.0|||||ANCOVA|||||||0.2765
71896060|NCT00923091|143314019|SUPERIORITY_OR_OTHER|||||||0.4964||95.0|||||Cochran-Mantel-Haenszel|||||||0.4964
71896061|NCT00923091|143314020|SUPERIORITY_OR_OTHER|||||||0.1301||95.0|||||ANCOVA|||||||0.1301
71676953|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||Mixed Models Analysis||Comparison at Day 11|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-0.9|-2.3|< 0.0001
71896062|NCT00923091|143314020|SUPERIORITY_OR_OTHER|||||||0.01301||95.0|||||ANCOVA|||||||0.01301
71896063|NCT00923091|143314021|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||ANCOVA|||||||0.0503
71896064|NCT00467649|143314024|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Fisher Exact|||||||0.0180
71896065|NCT01852344|143314055|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
71896066|NCT01852344|143314055|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||||||0.159
71896067|NCT01852344|143314056|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||||||0.236
71896068|NCT01852344|143314057|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
71896069|NCT04458857|143314107|OTHER||LS mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|-1.9|-0.16|||ANCOVA|||||-0.16|-1.90|0.0210
71676954|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.9|-1.5|||Mixed Models Analysis||Comparison at Day 12|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.5|-2.9|< 0.0001
71676955|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 13|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.6|< 0.0001
71676956|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.4|-1.0|||Mixed Models Analysis||Comparison at Day 14|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.0|-2.4|< 0.0001
71812765|NCT04425902|143127879|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.73|1.12|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.12|0.73|
71812766|NCT04425902|143127882|OTHER||Ratio of geometric least square mean|1.07|||||TWO_SIDED|90.0|0.94|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.94|
71845098|NCT06140290|143203945|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Here, Etrasimod 2mg (Treatment G) without practice session was the test treatment, while Etrasimod 2mg IR tablet (Treatment A) was the reference treatment.|Ratio of Adjusted Geometric Means|103.36|||||TWO_SIDED|90.0|86.04|124.16|||||Ratio (Test/Reference) and its associated 90% CI were expressed as percentages.|Analysis was performed using ANOVA model with treatment as a fixed effect.||124.16|86.04|
71845099|NCT02036970|143203957|SUPERIORITY||Mean Difference (Net)|-1.74||||0.8133|TWO_SIDED|95.0|-16.22|12.74||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary arterial hypertension (PAH).|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PAH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated and compared with placebo through 16 weeks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment and visit as fixed factors. A compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 used in the model with the change from baseline at Wk16 as primary endpoint.||12.74|-16.22|0.8133
71845100|NCT02036970|143203957|SUPERIORITY||Mean Difference (Net)|-3.17||||0.759|TWO_SIDED|95.0|-23.54|17.2||The p-value comparison is for the difference in the change in 6WMD from baseline at Week 16 for bardoxolone methyl relative to placebo in participants with pulmonary hypertension (PH)|Mixed Models Analysis||Mean difference (Net) = Bardoxolone methyl - Placebo.|Overall treatment effect in participants with PH. Mean overall treatment effect across all visits for change from baseline in 6MWD was estimated \& compared with placebo through 16 wks of treatment using mixed-model repeated measures (MMRM), with treatment group, visit, and the interaction between treatment \& visit as fixed factors. Compound symmetry covariance matrix was assumed. Data from Wks 4, 8, 12, and 16 were used in the model with the change from baseline at Wk 16 as the primary endpoint||17.20|-23.54|0.759
71845101|NCT02298842|143203986|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Binomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
71896070|NCT00069121|143314123|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0038|TWO_SIDED|95.0|0.69|0.93||This test used a two-sided significance level of 5%.|Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.93|0.69|0.0038
71896071|NCT00069121|143314124|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.78||||0.0015|TWO_SIDED|95.0|0.67|0.91|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.91|0.67|0.0015
71896072|NCT00069121|143314126|OTHER|Descriptive analysis only.|Hazard Ratio (HR)|0.83||||0.0367|TWO_SIDED|95.0|0.7|0.99|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.|||0.99|0.70|0.0367
71676957|NCT03233529|142872177|SUPERIORITY||Least-Square Mean of Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.7|-1.2|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was \<0.05.||-1.2|-2.7|< 0.0001
71676958|NCT01177293|142872180|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUC\[0- ∞\] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|89.78|||||TWO_SIDED|90.0|82.74|97.43||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.||97.43|82.74|
71676959|NCT01177293|142872181|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric mean ratio|99.73|||||TWO_SIDED|90.0|85.1|116.87||||||||116.87|85.10|
71812767|NCT04425902|143127883|OTHER||Ratio of geometric least square mean|1.05|||||TWO_SIDED|90.0|0.92|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.92|
71812768|NCT04425902|143127884|OTHER||Ratio of geometric least square mean|1.25|||||TWO_SIDED|90.0|0.96|1.63|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.63|0.96|
71812769|NCT04425902|143127887|OTHER||Ratio of geometric least square mean|0.73|||||TWO_SIDED|90.0|0.52|1.03|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.03|0.52|
71812770|NCT04425902|143127888|OTHER||Ratio of geometric least square mean|0.61|||||TWO_SIDED|90.0|0.45|0.82|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||0.82|0.45|
71812771|NCT04425902|143127889|OTHER||Ratio of geometric least square mean|0.78|||||TWO_SIDED|90.0|0.54|1.14|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.14|0.54|
71812772|NCT04425902|143127995|OTHER||Ratio of geometric least square mean|0.92|||||TWO_SIDED|90.0|0.49|1.71|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.71|0.49|
71812773|NCT04425902|143127996|OTHER||Ratio of geometric least square mean|0.93|||||TWO_SIDED|90.0|0.74|1.16|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.16|0.74|
71812774|NCT04425902|143127997|OTHER||Ratio of geometric least square mean|0.86|||||TWO_SIDED|90.0|0.43|1.72|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.72|0.43|
71812775|NCT04425902|143128000|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
71812776|NCT04425902|143128001|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.75|1.29|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.29|0.75|
71812777|NCT04425902|143128002|OTHER||Ratio of geometric least square mean|0.94|||||TWO_SIDED|90.0|0.73|1.22|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.22|0.73|
71812778|NCT04425902|143128005|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.93|1.3|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.30|0.93|
71896073|NCT03368404|143314129|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-102 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.34|0.13|||||Treatment difference : CBL-102 - Vismed Multi|||0.13|-1.34|
71812779|NCT04425902|143128006|OTHER||Ratio of geometric least square mean|0.99|||||TWO_SIDED|90.0|0.83|1.19|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.19|0.83|
71812780|NCT04425902|143128007|OTHER||Ratio of geometric least square mean|1.12|||||TWO_SIDED|90.0|0.88|1.44|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.44|0.88|
71812781|NCT04425902|143128010|OTHER||Ratio of geometric least square mean|0.9|||||TWO_SIDED|90.0|0.75|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.75|
71812782|NCT04425902|143128011|OTHER||Ratio of geometric least square mean|0.91|||||TWO_SIDED|90.0|0.76|1.09|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.09|0.76|
71812783|NCT04425902|143128012|OTHER||Ratio of geometric least square mean|0.85|||||TWO_SIDED|90.0|0.65|1.1|||||A mixed-effect model with treatment as a fixed effect and measurements within participant as repeated measures was performed on the natural ln-transformed parameter.|||1.10|0.65|
71812784|NCT02736825|143128029|NON_INFERIORITY|Non-inferiority margin of 15% between two independent percentages using the z-test with unpooled variance||||||0.367|||||||Z-test|||||||0.3670
71812785|NCT01373931|143128047|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.976|||||TWO_SIDED|90.0|0.907|1.05|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.05|0.907|
71896074|NCT03368404|143314130|SUPERIORITY|||||||0.0592||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0592
71812786|NCT01373931|143128047|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|0.914|||||TWO_SIDED|90.0|0.842|0.991|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||0.991|0.842|
71812787|NCT01373931|143128048|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|||||TWO_SIDED|90.0|-0.73|0.51|||Wilcoxon Signed Rank Test|Median difference is for ethinyl estradiol.||||0.51|-0.73|
71812788|NCT01373931|143128048|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.5|0.5|||Wilcoxon Signed Rank Test|Median difference is for norelgestromin.||||0.50|-0.50|
71812789|NCT01373931|143128049|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.07||||||90.0|1.0|1.15|||Mixed Models Analysis|Ratio of Geometric LS mean is for ethinyl estradiol.||||1.15|1.00|
71812790|NCT01373931|143128049|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.0||||||90.0|0.944|1.07|||Mixed Models Analysis|Ratio of Geometric LS mean is for norelgestromin.||||1.07|0.944|
71812791|NCT02228967|143128104|OTHER||||||=|0.274||||||A priori threshold for statistical significance was 0.05|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.274
71812792|NCT02228967|143128105|OTHER||||||=|0.083|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.083
71812793|NCT02228967|143128106|OTHER||||||=|0.028|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.028
71896075|NCT03368404|143314131|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
71812794|NCT02228967|143128107|OTHER||||||=|0.708|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.708
71812795|NCT02228967|143128108|OTHER||||||=|0.197||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.197
71812796|NCT02228967|143128109|OTHER||||||=|0.023||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||=0.023
71812797|NCT02228967|143128110|OTHER||||||<|0.001||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.||||<0.001
71812798|NCT02228967|143128111|OTHER||||||=|0.348||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||=0.348
71812799|NCT02228967|143128112|OTHER||Mean Difference (Final Values)|0.345|STANDARD_ERROR_OF_MEAN|0.203||0.091|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.091
71812800|NCT02228967|143128113|OTHER||Mean Difference (Net)|0.393|STANDARD_ERROR_OF_MEAN|0.362||0.278|TWO_SIDED|||||A priori alpha set at 0.05|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||.278
71812801|NCT02228967|143128114|OTHER||Mean Difference (Net)|3.163|STANDARD_ERROR_OF_MEAN|1.44||0.029|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.029
71812802|NCT02228967|143128115|OTHER||Mean Difference (Net)|-0.015||||0.897|TWO_SIDED|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.||||0.897
71812803|NCT02228967|143128116|OTHER|||||||0.15|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.15
71812804|NCT02228967|143128117|OTHER|||||||0.2||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.20
71812805|NCT02228967|143128118|OTHER|||||||0.38||||||A priori alpha set at 0.05.|Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.38
71812806|NCT02228967|143128119|OTHER|A priori alpha set at 0.05||||||0.48|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.48
71812807|NCT02228967|143128120|OTHER|A priori alpha set at 0.05.||||||0.09|||||||Linear mixed effects|||Linear mixed-effects models were used to analyze 5 pooled datasets derived from multiple imputation for intent to treat analyses.||||0.09
71812808|NCT02228967|143128121|OTHER|||||||0.08|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.08
71812809|NCT02228967|143128122|OTHER|||||||0.11|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.11
71812810|NCT02228967|143128123|OTHER|||||||0.84|||||||Linear mixed effects|||A priori alpha set at 0.05||||0.84
71812811|NCT00105235|143128124|SUPERIORITY_OR_OTHER||Proportion|0.22|||||TWO_SIDED|95.0|0.086|0.423|||Exact Binomial Confidence Interval|||||.423|.086|
71812812|NCT00105235|143128125|SUPERIORITY_OR_OTHER||Proportion|0.0|||||TWO_SIDED|95.0|0.0|0.3|||Exact Binomial Confidence Interval|||||0.3|0|
71812813|NCT00105235|143128127|SUPERIORITY_OR_OTHER||Proportion|0.2|||||TWO_SIDED|95.0|0.04|0.3|||Exact Binomial Confidence Interval|||||0.3|0.04|
71812814|NCT00105235|143128128|SUPERIORITY_OR_OTHER||Proportion|0.1|||||TWO_SIDED|95.0|0.01|0.2|||Exact Binomial Confidence Interval|||||0.2|0.01|
71812815|NCT02347657|143128133|SUPERIORITY||Least Squares (LS) Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|3.1|4.8|||Mixed model for repeated measures (MMRM)|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||4.8|3.1|<0.0001
71812816|NCT02347657|143128134|SUPERIORITY||LS mean difference|6.8|||<|0.0001|TWO_SIDED|95.0|5.3|8.3|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||8.3|5.3|<0.0001
71812817|NCT02347657|143128135|SUPERIORITY||Event Rate Ratio|0.65||||0.0054|TWO_SIDED|95.0|0.48|0.88|||Negative Binomial Regression|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.88|0.48|0.0054
71812818|NCT02347657|143128136|SUPERIORITY||LS mean difference|0.06||||0.4127|TWO_SIDED|95.0|-0.08|0.19|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.||0.19|-0.08|0.4127
71812819|NCT00261495|143128146|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|0.29||||0.011||95.0|-0.27|0.84||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.84|-0.27|0.011
71812820|NCT00261495|143128147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.706||95.0|-0.32|0.47||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.47|-0.32|0.706
71812821|NCT00261495|143128148|NON_INFERIORITY_OR_EQUIVALENCE|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.53|0.29||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."||0.29|-0.53|<0.001
71812822|NCT00261495|143128149|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.87||||0.065||95.0|-5.94|0.19||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.19|-5.94|0.065
71812823|NCT00261495|143128150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.348||95.0|-0.62|0.22||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.22|-0.62|0.348
71896076|NCT03368404|143314132|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
71896077|NCT03368404|143314133|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
71896078|NCT03368404|143314134|SUPERIORITY|||||||0.0176||||||Significance level 0.05|ANCOVA|||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 28 (Visit 4)||||0.0176
71896079|NCT03368404|143314134|SUPERIORITY|||||||0.001||||||Significance level 0.05|ANCOVA|Adjustment to baseline||Change from Baseline in Global Sum Score of Dry Eye Symptoms at Day 90 (Visit 5)||||0.0010
71896080|NCT03368404|143314135|SUPERIORITY|||||||0.0251||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Daily Activities"||||0.0251
71812824|NCT00261495|143128151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.616||95.0|-0.54|0.32||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."||0.32|-0.54|0.616
71896081|NCT03368404|143314135|SUPERIORITY|||||||0.0015||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) dimension:~Difficulties with work and handicap"||||0.0015
71896082|NCT03368404|143314135|SUPERIORITY|||||||0.2024||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Giving up makeup"||||0.2024
71896083|NCT03368404|143314135|SUPERIORITY|||||||0.0421||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acknowledgement of the Disease"||||0.0421
71896084|NCT03368404|143314135|SUPERIORITY|||||||0.3945||||||Significance level 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Acceptance of the disease"||||0.3945
71896085|NCT03368404|143314135|SUPERIORITY|||||||0.0536||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Fear for the Future"||||0.0536
71896086|NCT03368404|143314135|SUPERIORITY|||||||0.1998||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality if Life (OSD-QoL®) dimension:~Emotional well-being"||||0.1998
71896087|NCT03368404|143314135|SUPERIORITY|||||||0.0306||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||"Ocular Surface Disease-Quality of Life (OSD-QoL®) questions:~Global Question"||||0.0306
71896088|NCT03368404|143314136|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||>0.05
71896089|NCT03368404|143314137|SUPERIORITY||||||>|0.05||||||Significance level 0.05|ANCOVA|Adjustment for baseline||||||>0.05
71896090|NCT03368404|143314138|SUPERIORITY|||||||0.0017||||||Significance level of 0.05|Wilcoxon (Mann-Whitney)|||||||0.0017
71896091|NCT03414359|143314188|NON_INFERIORITY|As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.||||||0.1||||||The a priori threshold for statistical significance is, \<0.05|Wilcoxon (Mann-Whitney)|||To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.||||0.10
71896092|NCT01282814|143314204|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|115.85|||||TWO_SIDED|90.0|108.45|123.72|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||123.72|108.45|
71896093|NCT01282814|143314205|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.97|||||TWO_SIDED|90.0|103.68|116.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||116.63|103.68|
71896094|NCT01282814|143314206|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.46|||||TWO_SIDED|90.0|101.45|111.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||111.71|101.45|
71896095|NCT02104180|143314209|NON_INFERIORITY|An estimate of the difference between the pain felt by patient during the two dressings removals along with a 95% confidence interval (CI) has been derived. If the upper limit of the confidence interval was less than 13 mm, clinical non-inferiority of Tulle Gras versus Urgotul has been demonstrated.|Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-1.339|1.864|||||The pain intensity has been analyzed using analysis of variance (ANOVA). The model for this cross-over study included sequence, period and treatment as fixed effects and subject within sequence as random effect.|||1.864|-1.339|
71896096|NCT01524289|143314210|SUPERIORITY||Difference in Least Squares (LS) Means|-39.7|||<|0.001|TWO_SIDED|95.0|-45.7|-33.7|||Constrained Longitudinal Data Analysis|Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model.||||-33.7|-45.7|<0.001
71896097|NCT01524289|143314211|OTHER|Pre-specified|Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-11.5|8.4|||||||Miettinen and Nurminen|8.4|-11.5|
71896098|NCT01524289|143314212|OTHER|Pre-specified|Difference in Percentages|4.5|||||TWO_SIDED|95.0|-4.8|12.6|||||||Miettinen and Nurminen|12.6|-4.8|
71896099|NCT01524289|143314213|OTHER|Pre-specified|Difference in Percentages|-0.9|||||TWO_SIDED|95.0|-8.9|5.6|||||||Miettinen \& Nurminen|5.6|-8.9|
71896100|NCT01524289|143314214|OTHER|Pre-specified|Difference in Percentages|1.0|||||TWO_SIDED|95.0|-5.5|6.1|||||||Miettinen and Nurminen|6.1|-5.5|
71676960|NCT01177293|142872182|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|86.67|||||TWO_SIDED|90.0|79.57|94.42||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.||94.42|79.57|
71812825|NCT00261495|143128152|SUPERIORITY_OR_OTHER|||||||0.249||||||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.||"Null hypothesis: There is no association between study medication and dose escalation.~Alternative hypothesis: There is an association between study medication and dose escalation."||||0.249
71812826|NCT00261495|143128153|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.05||95.0|0.0|0.84||0.05 two-sided testing, exploratory comparison|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.84|-0.00|0.050
71896101|NCT01524289|143314215|OTHER|Pre-Specified|Difference in Percentages|-8.4||||0.168|TWO_SIDED|95.0|-20.1|3.5|||Miettinen and Nurminen|||||3.5|-20.1|0.168
71896102|NCT01524289|143314216|OTHER|Pre-specified|Difference in Percentages|-7.4||||0.179|TWO_SIDED|95.0|-18.7|3.3|||Miettinen and Nurminen|||||3.3|-18.7|0.179
71896103|NCT01524289|143314217|OTHER|Pre-specified|Difference in Percentages|-13.9||||0.011|TWO_SIDED|95.0|-25.0|-3.1|||Miettinen and Nurminen|||||-3.1|-25.0|0.011
71896104|NCT01524289|143314218|OTHER|Pre-specified|Difference in Percentages|1.5||||0.696|TWO_SIDED|95.0|-6.8|8.4|||Miettinen and Nurminen|||||8.4|-6.8|0.696
71896105|NCT01524289|143314219|OTHER|Pre-specified|Difference in Percentages|0.5||||0.48|TWO_SIDED|95.0|-3.2|2.8|||Miettinen and Nurminen|||||2.8|-3.2|0.480
71896106|NCT01524289|143314220|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
71812827|NCT00261495|143128154|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.105||95.0|-0.06|0.67||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-0.06|0.105
71812828|NCT00261495|143128155|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.058||95.0|-0.01|0.79||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.79|-0.01|0.058
71896107|NCT01524289|143314221|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|1.9|||Miettinen and Nurminen|||||1.9|-3.7|>0.999
71896108|NCT01524289|143314222|OTHER|Pre-specified|Difference in Percentages|0.5||||0.722|TWO_SIDED|95.0|-4.0|3.5|||Miettinen and Nurminen|||||3.5|-4.0|0.722
71896109|NCT01524289|143314223|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
71896110|NCT01524289|143314224|OTHER|Pre-specified|Difference in Percentages|-1.0||||0.157|TWO_SIDED|95.0|-5.4|0.9|||Miettinen and Nurminen|||||0.9|-5.4|0.157
71896111|NCT01524289|143314225|OTHER|Pre-specified|Difference in Percentages|1.5||||0.218|TWO_SIDED|95.0|-2.2|4.3|||Miettinen and Nurminen|||||4.3|-2.2|0.218
71896112|NCT01524289|143314226|OTHER|Pre-specified|Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-3.6|1.9|||Miettinen and Nurminen|||||1.9|-3.6|>0.999
71896113|NCT01524289|143314227|SUPERIORITY||Difference in Least Squares (LS) Means|102.1|||<|0.001|TWO_SIDED|95.0|94.2|110.1|||Constrained Longitudinal Data Analysis|||||110.1|94.2|<0.001
71896114|NCT01524289|143314228|SUPERIORITY||Difference in LS Means|-36.4|||<|0.001|TWO_SIDED|95.0|-41.7|-31.1|||Constrained Longitudinal Data Analysis|||||-31.1|-41.7|<0.001
71896115|NCT01524289|143314229|SUPERIORITY||Difference in LS Means|-24.8|||<|0.001|TWO_SIDED|95.0|-29.5|-20.1|||Constrained Longitudinal Data Analysis|||||-20.1|-29.5|<0.001
71896116|NCT01524289|143314230|SUPERIORITY||Difference in LS Means|32.9|||<|0.001|TWO_SIDED|95.0|28.2|37.6|||Constrained Longitudinal Data Analysis|||||37.6|28.2|<0.001
71896117|NCT01524289|143314231|SUPERIORITY||Median Difference (Final Values)|-27.9|||<|0.001|TWO_SIDED|95.0|-34.7|-21.2|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test.|||-21.2|-34.7|<0.001
71896118|NCT01855789|143314239|NON_INFERIORITY|Non-inferiority of TCZ + PBO was claimed if the upper bound of the 95% confidence interval (CI) for the mean difference was below 0.6.|Estimated Mean Difference|0.318|STANDARD_ERROR_OF_MEAN|0.139|||TWO_SIDED|95.0|0.045|0.592||||||Analysis of covariance (ANCOVA) model included Week 24 DAS28 as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>/=100 kg qw), participant anti-tumor necrosis factor (anti-TNF) exposure (Yes/No).||0.592|0.045|
71896119|NCT01855789|143314240|SUPERIORITY||ACR 20 Response Rate Difference|-10.2||||0.0746|TWO_SIDED|95.0|-20.2|-0.2|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.2|-20.2|0.0746
71676961|NCT01905553|142872196|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.77||||||||0.770|0.670|
71812829|NCT00261495|143128156|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.21||95.0|-0.13|0.59||0.05 two-sided test|ANCOVA||Mean difference calculated: hdromorphone minus oxycodone|Exploratory comparison||0.59|-0.13|0.210
71812830|NCT00261495|143128157|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.941||95.0|-4.87|4.52||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.52|-4.87|0.941
71812831|NCT00261495|143128158|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.073||95.0|-0.03|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.03|0.073
71812832|NCT00261495|143128159|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.431||95.0|-0.52|0.22||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.22|-0.52|0.431
71812833|NCT00261495|143128160|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.835||95.0|-0.4|0.33||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.33|-0.40|0.835
71812834|NCT00261495|143128161|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.837||95.0|-5.36|4.35||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.35|-5.36|0.837
71812835|NCT00261495|143128162|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.832||95.0|-0.38|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.38|0.832
71812836|NCT00261495|143128163|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.143||95.0|-0.1|0.71||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.71|-0.10|0.143
71812837|NCT00261495|143128164|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.345||95.0|-0.23|0.64||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.64|-0.23|0.345
71812838|NCT00261495|143128165|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14||||0.552||95.0|-0.33|0.61||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.61|-0.33|0.552
71812839|NCT00261495|143128166|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.47||||0.042||95.0|0.02|0.93||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.93|0.02|0.042
71812840|NCT00261495|143128167|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.171||95.0|-0.14|0.81||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.81|-0.14|0.171
71812841|NCT00261495|143128168|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.475||95.0|-0.31|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.65|-0.31|0.475
71812842|NCT00261495|143128169|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.359||95.0|-0.26|0.72||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.72|-0.26|0.359
71812843|NCT00261495|143128170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.611||95.0|-0.52|0.3||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.30|-0.52|0.611
71812844|NCT00261495|143128171|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.526||95.0|-0.6|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.31|-0.60|0.526
71812845|NCT00261495|143128172|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.769||95.0|-0.49|0.36||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.36|-0.49|0.769
71812846|NCT00261495|143128173|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.843||95.0|-0.4|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.40|0.843
71812847|NCT00261495|143128174|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.977||95.0|-0.45|0.44||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.44|-0.45|0.977
71812848|NCT00261495|143128175|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.977||95.0|-0.47|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.49|-0.47|0.977
71812849|NCT00261495|143128176|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.902||95.0|-0.51|0.45||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.45|-0.51|0.902
71812850|NCT00261495|143128178|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.36||||0.169||95.0|-5.74|1.02||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.02|-5.74|0.169
71812851|NCT00261495|143128179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.245||95.0|-5.09|1.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.31|-5.09|0.245
71812852|NCT00261495|143128180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.64||||0.071||95.0|-5.51|0.23||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.23|-5.51|0.071
71812853|NCT00261495|143128181|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03||||0.297||95.0|-5.85|1.8||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.80|-5.85|0.297
71812854|NCT00261495|143128182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.41||||0.205||95.0|-1.32|6.14||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.14|-1.32|0.205
71812855|NCT00261495|143128183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.35||||0.107||95.0|-7.43|0.73||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.73|-7.43|0.107
71812856|NCT00261495|143128184|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.475||95.0|-2.8|6.0||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||6.00|-2.80|0.475
71812857|NCT00261495|143128185|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.16||||0.02||95.0|-7.67|-0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||-0.65|-7.67|0.020
71812858|NCT00261495|143128186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88||95.0|-0.3|0.26||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.30|0.880
71812859|NCT00261495|143128187|SUPERIORITY_OR_OTHER|||||||0.32|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.320
71812860|NCT00261495|143128192|SUPERIORITY_OR_OTHER|||||||0.575|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.575
71812861|NCT00261495|143128193|SUPERIORITY_OR_OTHER|||||||0.807|||||||Cochran-Mantel-Haenszel|||Exploratory comparison||||0.807
71676962|NCT01905553|142872197|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||TWO_SIDED|90.0|0.67|0.769||||||||0.769|0.670|
71812862|NCT00261495|143128194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.118||95.0|-5.88|0.67|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.67|-5.88|0.118
71812863|NCT00261495|143128195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.956||95.0|-3.08|2.91|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.91|-3.08|0.956
71812864|NCT00261495|143128196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.299||95.0|-0.08|0.26|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.26|-0.08|0.299
71812865|NCT00261495|143128197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.471||95.0|-4.2|1.95|||ANCOVA||Mean difference calculated: hydromorphone minus oxymorphone|Exploratory comparison||1.95|-4.20|0.471
71812866|NCT00261495|143128198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.84||||0.025||95.0|0.48|7.19|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.19|0.48|0.025
71812867|NCT00261495|143128199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.556||95.0|-5.61|10.42|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||10.42|-5.61|0.556
71845102|NCT02298842|143203987|NON_INFERIORITY|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH\> 6.2 will be at least 95%. This will be achieved if zero failures (pH\<=6.2) is seen.|Simple sample proportion|100.0|STANDARD_DEVIATION|0.0|||ONE_SIDED|95.0|95.1||||Exact Bionomial Confidence Interval||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"A success is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria."|||95.1|
71845103|NCT02298842|143203988|NON_INFERIORITY|If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|15.099|STANDARD_DEVIATION|5.6367|||ONE_SIDED|97.5||16.738|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selectin's mean difference, Test - 1.25 \* Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.||16.738||
71896120|NCT01855789|143314240|SUPERIORITY||ACR 20 Response Rate Difference|-8.8||||0.1159|TWO_SIDED|95.0|-19.3|1.6|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.6|-19.3|0.1159
71896121|NCT01855789|143314240|SUPERIORITY||ACR 20 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-15.8|-0.6|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.6|-15.8|
71676963|NCT01905553|142872198|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.449|||||TWO_SIDED|90.0|0.38|0.53||||||||0.530|0.380|
71812868|NCT00261495|143128200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12||||0.551||95.0|-9.11|4.88|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||4.88|-9.11|0.551
71812869|NCT00261495|143128201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.98||||0.207||95.0|-7.63|1.66|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.66|-7.63|0.207
71812870|NCT00261495|143128202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.46||||0.123||95.0|-5.6|0.68|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.68|-5.60|0.123
71812871|NCT00261495|143128203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.602||95.0|-4.27|2.48|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.48|-4.27|0.602
71812872|NCT00261495|143128204|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.647||95.0|-2.14|3.44|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||3.44|-2.14|0.647
71812873|NCT00261495|143128205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.627||95.0|-0.17|0.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||0.10|-0.17|0.627
71812874|NCT00261495|143128206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.414||95.0|-4.45|1.84|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||1.84|-4.45|0.414
71812875|NCT00261495|143128207|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.05||||0.01||95.0|0.94|7.16|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.16|0.94|0.010
71812876|NCT00261495|143128208|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.955||95.0|-7.2|7.62|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.62|-7.20|0.955
71812877|NCT00261495|143128209|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.669||95.0|-4.72|7.34|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||7.34|-4.72|0.669
71812878|NCT00261495|143128210|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.17||||0.595||95.0|-3.15|5.49|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||5.49|-3.15|0.595
71845104|NCT02298842|143203989|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Median Difference (Final Values)|-0.418|STANDARD_DEVIATION|4.5531|||ONE_SIDED|97.5|-1.544||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-1.544|
71845105|NCT02298842|143203990|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-0.667|STANDARD_DEVIATION|6.7882|||ONE_SIDED|97.5|-2.499||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-2.499|
71896122|NCT01855789|143314241|SUPERIORITY||ACR 50 Response Rate Difference|-13.6||||0.0377|TWO_SIDED|95.0|-24.8|-2.4|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-2.4|-24.8|0.0377
71676964|NCT01767506|142872202|SUPERIORITY||Odds Ratio (OR)|2.6|||>|0.05|TWO_SIDED|95.0|0.56|11.9|||Regression, Logistic||||The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.|11.9|0.56|>0.05
71812879|NCT00261495|143128211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94||||0.543||95.0|-3.98|2.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison||2.10|-3.98|0.543
71812880|NCT01932697|143128243|SUPERIORITY|||||||0.01|||||||Paired t-test|||||||.01
71812881|NCT01932697|143128244|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
71812882|NCT01932697|143128245|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
71812883|NCT01932697|143128246|SUPERIORITY||||||<|0.001|||||||Paired t-test|||||||<0.001
71812884|NCT05701995|143128286|SUPERIORITY||Odds Ratio (OR)|7.7||||0.0001|TWO_SIDED|95.0|2.5|23.6|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||23.6|2.5|0.0001
71812885|NCT05701995|143128286|SUPERIORITY||Odds Ratio (OR)|8.5||||0.0003|TWO_SIDED|95.0|2.4|30.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||30.4|2.4|0.0003
71812886|NCT05701995|143128287|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0107|TWO_SIDED|95.0|1.2|4.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set||4.4|1.2|0.0107
71812887|NCT05701995|143128287|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0175|TWO_SIDED|95.0|1.2|4.7|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||4.7|1.2|0.0175
71812888|NCT05701995|143128288|SUPERIORITY||Adjusted Mean Difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.2|||Covariance model|||Full Analysis Set||-1.2|-2.9|<0.0001
71812889|NCT05701995|143128288|SUPERIORITY||Adjusted Mean Difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.0|-1.3|||Covariance model|||Full Analysis Set Sub-population||-1.3|-3.0|<0.0001
71812890|NCT05701995|143128289|SUPERIORITY||Odds Ratio (OR)|5.9||||0.0004|TWO_SIDED|95.0|2.0|17.4|||Stratified Cochran-Mantel-Haenszel (CMH)|||Full Analysis Set Sub-population||17.4|2.0|0.0004
71812891|NCT04803214|143128297|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
71812892|NCT04803214|143128298|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71812893|NCT04803214|143128299|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71812894|NCT00985010|143128323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|5.0||0.05|||||||Chi-squared||The difference is between the percentage of deaths (males versus females) after six months in the patients with hepatic encephalophathy.|Clinical evolution was reported as percentage (still alive or death after six months of follow up).||||0.05
71812895|NCT00985010|143128324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.05|STANDARD_DEVIATION|10.72||0.05||95.0|||||Wilcoxon (Mann-Whitney)||The difference is between manganese levels of women minus manganese levels of men.|Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).||||0.05
71845106|NCT02298842|143203991|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|46.1|STANDARD_DEVIATION|23.056|||ONE_SIDED|97.5|40.02||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||40.020|
71845107|NCT02298842|143203992|NON_INFERIORITY|Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|12.314|STANDARD_DEVIATION|6.0422|||ONE_SIDED|97.5||13.981|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selection's mean difference, Test - 1.25 \* Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.||13.981||
71845108|NCT02298842|143203993|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-3.042|STANDARD_DEVIATION|5.422|||ONE_SIDED|97.5|-4.407||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.407|
71845109|NCT02298842|143203994|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-2.389|STANDARD_DEVIATION|9.0544|||ONE_SIDED|97.5|-4.915||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||-4.915|
71845110|NCT02298842|143203995|NON_INFERIORITY|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|43.8|STANDARD_DEVIATION|26.05|||ONE_SIDED|97.5|36.821||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 \* Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|||36.821|
71845111|NCT02722434|143204003|SUPERIORITY|||||||0.1228|||||||Chi-squared|||||||0.1228
71845112|NCT02722434|143204004|SUPERIORITY|||||||0.004|||||||Fisher Exact|||||||0.004
71845113|NCT02722434|143204005|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Sensory Subscale||||0.79
71845114|NCT02722434|143204005|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Motor Subscale||||0.43
71845115|NCT02722434|143204005|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Autonomic Subscale||||0.97
71845116|NCT04732000|143204029|OTHER||Median Difference (Final Values)|-0.1373||||0.549|TWO_SIDED|||||The a priori threshold for statistical significance is \< 0.05.|Mann Whitney test, 2-sided|||||||0.5490
71845117|NCT01767467|143204033|NON_INFERIORITY|The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (\>) 3.|Adjusted Geometric Mean Concentration|29.75|||<|0.0001|TWO_SIDED|95.0|21.09|41.96||The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1|Repeated measurement model|||The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.||41.96|21.09|<0.0001
71845118|NCT05613907|143204215|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.885||0.005|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.005
71845119|NCT05613907|143204215|SUPERIORITY||Mean Difference (Net)|-17.8|STANDARD_ERROR_OF_MEAN|6.512||0.04|TWO_SIDED|95.0|-34.895|-0.705|||ANOVA|||||-0.705|-34.895|0.040
71845120|NCT05613907|143204215|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.668||0.94|TWO_SIDED|95.0|-5.829|13.429|||ANOVA|||||13.429|-5.829|0.940
71845121|NCT05613907|143204216|SUPERIORITY||Z statistic|-0.862||||0.388|TWO_SIDED||||||Wilcoxon Signed Ranks|||The null hypothesis is that there will be no significant difference in the EuroQol 5-D domains at 1 year compared to baseline.||||0.388
71845122|NCT05613907|143204217|SUPERIORITY||Z statistic|-0.033||||0.974|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is that there will be no statistical difference in patient self-reported ability to perform basic self-care||||0.974
71845123|NCT05613907|143204218|SUPERIORITY||Z statistic|-1.564||||0.118|TWO_SIDED||||||Wilcoxon signed rank|||The null hypothesis is no improvement in ability to perform usual activities at 1 year.||||0.118
71845124|NCT05613907|143204219|SUPERIORITY||Z statistic|-2.364||||0.018|TWO_SIDED||||||Wilcoxon signed rank|||||||0.018
71845125|NCT05613907|143204220|SUPERIORITY||Z statistic|-1.311||||0.19|TWO_SIDED|||||The null hypothesis is that there will be no difference in anxiety and/or depression compared to the initial visit.|Wilcoxon signed rank|||||||0.190
71845126|NCT05613907|143204221|SUPERIORITY||Mean Difference (Net)|-26.846|STANDARD_ERROR_OF_MEAN|8.604||0.027|TWO_SIDED|95.0|-50.762|-2.39|||ANOVA|||||-2.390|-50.762|0.027
71845127|NCT05613907|143204221|SUPERIORITY||Mean Difference (Net)|-27.615|STANDARD_ERROR_OF_MEAN|8.715||0.024|TWO_SIDED|95.0|-51.837|-3.394|||ANOVA|||||-3.394|-51.837|0.024
71845128|NCT05613907|143204221|SUPERIORITY||Mean Difference (Net)|-0.769|STANDARD_ERROR_OF_MEAN|4.535||1|TWO_SIDED|95.0|-13.374|11.836|||ANOVA|||||11.836|-13.374|1.000
71845129|NCT05613907|143204222|SUPERIORITY||Mean Difference (Net)|-14.27|STANDARD_ERROR_OF_MEAN|4.052||0.048|TWO_SIDED|95.0|-37.05|-6.15|||ANOVA|||||-6.150|-37.050|0.048
71845130|NCT05613907|143204222|SUPERIORITY||Median Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|3.751||1|TWO_SIDED|95.0|-12.893|13.751|||ANOVA|||||13.751|-12.893|1.000
71845131|NCT05613907|143204222|SUPERIORITY||Mean Difference (Net)|12.26|STANDARD_ERROR_OF_MEAN|5.186||0.163|TWO_SIDED|95.0|-4.762|29.333|||ANOVA|||||29.333|-4.762|0.163
71845132|NCT05485805|143204289|OTHER||Geometric LS means|-5.95|||=|0.004|TWO_SIDED|95.0|-9.946|-1.954|||ANCOVA|||||-1.954|-9.946|= 0.004
71845133|NCT05485805|143204289|OTHER||Geometric LS means|6.161|||=|0.003|TWO_SIDED|95.0|2.161|10.161|||ANCOVA|||||10.161|2.161|= 0.003
71845134|NCT05485805|143204289|OTHER||Geometric LS means|25.936|||<|0.001|TWO_SIDED|95.0|20.317|31.556|||ANCOVA|||||31.556|20.317|< 0.001
71845135|NCT05485805|143204289|OTHER||Geometric LS means|-3.476|||=|0.325|TWO_SIDED|95.0|-10.41|3.457|||ANCOVA|||||3.457|-10.41|= 0.325
71845136|NCT05485805|143204289|OTHER||Geometric LS means|0.211|||=|0.918|TWO_SIDED|95.0|-3.798|4.22|||ANCOVA|||||4.22|-3.798|= 0.918
71896123|NCT01855789|143314241|SUPERIORITY||ACR 50 Response Rate Difference|-15.0||||0.013|TWO_SIDED|95.0|-26.2|-3.7|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.7|-26.2|0.0130
71845137|NCT05485805|143204289|OTHER||Geometric LS means|32.097|||<|0.001|TWO_SIDED|95.0|26.484|37.71|||ANCOVA|||||37.71|26.484|< 0.001
71845138|NCT05485805|143204289|OTHER||Geometric LS means|22.46|||<|0.001|TWO_SIDED|95.0|16.753|28.166|||ANCOVA|||||28.166|16.753|< 0.001
71845139|NCT05485805|143204289|OTHER||Geometric LS means|26.147|||<|0.001|TWO_SIDED|95.0|20.529|31.765|||ANCOVA|||||31.765|20.529|< 0.001
71845140|NCT05485805|143204289|OTHER||Geometric LS means|28.62|||<|0.001|TWO_SIDED|95.0|22.921|34.32|||ANCOVA|||||34.32|22.921|< 0.001
71896124|NCT01855789|143314241|SUPERIORITY||ACR 50 Response Rate Difference|-10.9|||||TWO_SIDED|95.0|-21.4|-0.4|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||-0.4|-21.4|
71896125|NCT01855789|143314242|SUPERIORITY||ACR 70 Response Rate Difference|-8.2||||0.3599|TWO_SIDED|95.0|-19.2|2.9|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||2.9|-19.2|0.3599
71896126|NCT01855789|143314242|SUPERIORITY||ACR 70 Response Rate Difference|-11.6||||0.0663|TWO_SIDED|95.0|-22.8|-0.3|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-0.3|-22.8|0.0663
71896127|NCT01855789|143314242|SUPERIORITY||ACR 70 Response Rate Difference|-8.2|||||TWO_SIDED|95.0|-19.4|3.1|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24||3.1|-19.4|
71896128|NCT01855789|143314243|SUPERIORITY||DAS28 Worsening Rate Difference|7.5||||0.2371|TWO_SIDED|95.0|-2.4|17.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||17.3|-2.4|0.2371
71896129|NCT01855789|143314243|SUPERIORITY||DAS28 Worsening Rate Difference|3.4||||0.4811|TWO_SIDED|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||13.7|-6.9|0.4811
71845141|NCT05485805|143204289|OTHER||Geometric LS means|22.671|||<|0.001|TWO_SIDED|95.0|16.966|28.375|||ANCOVA|||||28.375|16.966|< 0.001
71845142|NCT05485805|143204290|OTHER||Geometric LS means|-1.602|||<|0.001|TWO_SIDED|95.0|-2.548|-0.656|||ANCOVA|||0-2 hours post-dose||-0.656|-2.548|< 0.001
71845143|NCT05485805|143204290|OTHER||Geometric LS means|0.976|||=|0.043|TWO_SIDED|95.0|0.029|1.923|||ANCOVA|||0-2 hours post-dose||1.923|0.029|= 0.043
71845144|NCT05485805|143204290|OTHER||Geometric LS means|6.097|||<|0.001|TWO_SIDED|95.0|4.766|7.427|||ANCOVA|||0-2 hours post-dose||7.427|4.766|< 0.001
71845145|NCT05485805|143204290|OTHER||Geometric LS means|0.31|||=|0.711|TWO_SIDED|95.0|-1.332|1.951|||ANCOVA|||0-2 hours post-dose||1.951|-1.332|= 0.711
71845146|NCT05485805|143204290|OTHER||Geometric LS means|-0.626|||=|0.196|TWO_SIDED|95.0|-1.575|0.323|||ANCOVA|||0-2 hours post-dose||0.323|-1.575|= 0.196
71845147|NCT05485805|143204290|OTHER||Geometric LS means|7.073|||<|0.001|TWO_SIDED|95.0|5.744|8.402|||ANCOVA|||0-2 hours post-dose||8.402|5.744|< 0.001
71896130|NCT01855789|143314244|SUPERIORITY||DAS28 Remission Rate Difference|-9.5||||0.1062|TWO_SIDED|95.0|-20.9|1.8|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||1.8|-20.9|0.1062
71676965|NCT01767506|142872203|SUPERIORITY||Mean Difference (Final Values)|3.9||||1|TWO_SIDED||||||Fisher Exact|||||||1
71676966|NCT03854370|142872221|SUPERIORITY|||||||0.23|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub.||||0.23
71676967|NCT03854370|142872221|SUPERIORITY|||||||0.31|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.31
71676968|NCT03854370|142872221|SUPERIORITY|||||||0.35|||||||Fisher Exact|||Comparison of Chlorhexidine versus iodine post surgical scrub||||.35
71676969|NCT03854370|142872221|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of chloroxynel versus iodine post surgical scrub||||.61
71845148|NCT05485805|143204290|OTHER||Geometric LS means|6.406|||<|0.001|TWO_SIDED|95.0|5.055|7.757|||ANCOVA|||0-2 hours post-dose||7.757|5.055|< 0.001
71845149|NCT05485805|143204290|OTHER||Geometric LS means|5.471|||<|0.001|TWO_SIDED|95.0|4.141|6.801|||ANCOVA|||0-2 hours post-dose||6.801|4.141|< 0.001
71845150|NCT05485805|143204290|OTHER||Geometric LS means|7.383|||<|0.001|TWO_SIDED|95.0|6.033|8.732|||ANCOVA|||0-2 hours post-dose||8.732|6.033|< 0.001
71845151|NCT05485805|143204290|OTHER||Geometric LS means|5.78|||<|0.001|TWO_SIDED|95.0|4.43|7.131|||ANCOVA|||0-2 hours post-dose||7.131|4.43|< 0.001
71845152|NCT05485805|143204291|OTHER||Geometric LS means|-0.586|||<|0.001|TWO_SIDED|95.0|-0.903|-0.269|||ANCOVA|||0-2 hours post-dose||-0.269|-0.903|< 0.001
71845153|NCT05485805|143204291|OTHER||Geometric LS means|0.454|||=|0.005|TWO_SIDED|95.0|0.136|0.771|||ANCOVA|||0-2 hours post-dose||0.771|0.136|= 0.005
71845154|NCT05485805|143204291|OTHER||Geometric LS means|2.369|||<|0.001|TWO_SIDED|95.0|1.923|2.815|||ANCOVA|||0-2 hours post-dose||2.815|1.923|< 0.001
71845155|NCT05485805|143204291|OTHER||Geometric LS means|-0.169|||=|0.548|TWO_SIDED|95.0|-0.719|0.382|||ANCOVA|||0-2 hours post-dose||0.382|-0.719|= 0.548
71845156|NCT05485805|143204291|OTHER||Geometric LS means|-0.132|||=|0.415|TWO_SIDED|95.0|-0.451|0.186|||ANCOVA|||0-2 hours post-dose||0.186|-0.451|= 0.415
71845157|NCT05485805|143204291|OTHER||Geometric LS means|2.823|||<|0.001|TWO_SIDED|95.0|2.377|3.268|||ANCOVA|||0-2 hours post-dose||3.268|2.377|< 0.001
71845158|NCT05485805|143204291|OTHER||Geometric LS means|2.201|||<|0.001|TWO_SIDED|95.0|1.748|2.654|||ANCOVA|||0-2 hours post-dose||2.654|1.748|< 0.001
71845159|NCT05485805|143204291|OTHER||Geometric LS means|2.237|||<|0.001|TWO_SIDED|95.0|1.791|2.683|||ANCOVA|||0-2 hours post-dose||2.683|1.791|< 0.001
71845160|NCT05485805|143204291|OTHER||Geometric LS means|2.654|||<|0.001|TWO_SIDED|95.0|2.202|3.106|||ANCOVA|||0-2 hours post-dose||3.106|2.202|< 0.001
71845161|NCT05485805|143204291|OTHER||Geometric LS means|2.068|||<|0.001|TWO_SIDED|95.0|1.615|2.521|||ANCOVA|||0-2 hours post-dose||2.521|1.615|< 0.001
71845162|NCT05485805|143204291|OTHER||Geometric LS means|-1.338|||<|0.001|TWO_SIDED|95.0|-2.133|-0.542|||ANCOVA|||0-4 hours post-dose||-0.542|-2.133|< 0.001
71845163|NCT05485805|143204291|OTHER||Geometric LS means|1.016|||=|0.012|TWO_SIDED|95.0|0.22|1.813|||ANCOVA|||0-4 hours post-dose||1.813|0.22|= 0.012
71845164|NCT05485805|143204291|OTHER||Geometric LS means|5.982|||<|0.001|TWO_SIDED|95.0|4.864|7.101|||ANCOVA|||0-4 hours post-dose||7.101|4.864|< 0.001
71845165|NCT05485805|143204291|OTHER||Geometric LS means|-1.048|||=|0.136|TWO_SIDED|95.0|-2.428|0.332|||ANCOVA|||0-4 hours post-dose||0.332|-2.428|= 0.136
71845166|NCT05485805|143204291|OTHER||Geometric LS means|-0.321|||=|0.43|TWO_SIDED|95.0|-1.119|0.477|||ANCOVA|||0-4 hours post-dose||0.477|-1.119|= 0.43
71845167|NCT05485805|143204291|OTHER||Geometric LS means|6.999|||<|0.001|TWO_SIDED|95.0|5.881|8.116|||ANCOVA|||0-4 hours post-dose||8.116|5.881|< 0.001
71845168|NCT05485805|143204291|OTHER||Geometric LS means|4.934|||<|0.001|TWO_SIDED|95.0|3.798|6.07|||ANCOVA|||0-4 hours post-dose||6.07|3.798|< 0.001
71845169|NCT05485805|143204291|OTHER||Geometric LS means|5.661|||<|0.001|TWO_SIDED|95.0|4.543|6.779|||ANCOVA|||0-4 hours post-dose||6.779|4.543|< 0.001
71845170|NCT05485805|143204291|OTHER||Geometric LS means|5.951|||<|0.001|TWO_SIDED|95.0|4.816|7.085|||ANCOVA|||0-4 hours post-dose||7.085|4.816|< 0.001
71845171|NCT05485805|143204291|OTHER||Geometric LS means|4.613|||<|0.001|TWO_SIDED|95.0|3.478|5.749|||ANCOVA|||0-4 hours post-dose||5.749|3.478|< 0.001
71845172|NCT05485805|143204291|OTHER||Geometric LS means|-1.963|||=|0.003|TWO_SIDED|95.0|-3.254|-0.673|||ANCOVA|||0-6 hours post-dose||-0.673|-3.254|= 0.003
71845173|NCT05485805|143204291|OTHER||Geometric LS means|1.641|||=|0.013|TWO_SIDED|95.0|0.35|2.933|||ANCOVA|||0-6 hours post-dose||2.933|0.35|= 0.013
71845174|NCT05485805|143204291|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.377|11.006|||ANCOVA|||0-6 hours post-dose||11.006|7.377|< 0.001
71845175|NCT05485805|143204291|OTHER||Geometric LS means|-1.642|||=|0.15|TWO_SIDED|95.0|-3.881|0.597|||ANCOVA|||0-6 hours post-dose||0.597|-3.881|= 0.15
71845176|NCT05485805|143204291|OTHER||Geometric LS means|-0.322|||=|0.625|TWO_SIDED|95.0|-1.617|0.972|||ANCOVA|||0-6 hours post-dose||0.972|-1.617|= 0.625
71845177|NCT05485805|143204291|OTHER||Geometric LS means|10.833|||<|0.001|TWO_SIDED|95.0|9.02|12.645|||ANCOVA|||0-6 hours post-dose||12.645|9.02|< 0.001
71845178|NCT05485805|143204291|OTHER||Geometric LS means|7.55|||<|0.001|TWO_SIDED|95.0|5.707|9.392|||ANCOVA|||0-6 hours post-dose||9.392|5.707|< 0.001
71845179|NCT05485805|143204291|OTHER||Geometric LS means|8.869|||<|0.001|TWO_SIDED|95.0|7.055|10.683|||ANCOVA|||0-6 hours post-dose||10.683|7.055|< 0.001
71845180|NCT05485805|143204291|OTHER||Geometric LS means|9.191|||<|0.001|TWO_SIDED|95.0|7.351|11.031|||ANCOVA|||0-6 hours post-dose||11.031|7.351|< 0.001
71845181|NCT05485805|143204291|OTHER||Geometric LS means|7.228|||<|0.001|TWO_SIDED|95.0|5.386|9.07|||ANCOVA|||0-6 hours post-dose||9.07|5.386|< 0.001
71845182|NCT05485805|143204291|OTHER||Geometric LS means|-2.398|||=|0.009|TWO_SIDED|95.0|-4.185|-0.61|||ANCOVA|||0-8 hours post-dose||-0.61|-4.185|= 0.009
71845183|NCT05485805|143204291|OTHER||Geometric LS means|2.4|||=|0.009|TWO_SIDED|95.0|0.61|4.189|||ANCOVA|||0-8 hours post-dose||4.189|0.61|= 0.009
71845184|NCT05485805|143204291|OTHER||Geometric LS means|11.898|||<|0.001|TWO_SIDED|95.0|9.384|14.412|||ANCOVA|||0-8 hours post-dose||14.412|9.384|< 0.001
71896131|NCT01855789|143314244|SUPERIORITY||DAS28 Remission Rate Difference|-6.8||||0.3611|TWO_SIDED|95.0|-18.2|4.6|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||4.6|-18.2|0.3611
71896132|NCT01855789|143314245|SUPERIORITY||Low DAS28 Rate Difference|-13.6||||0.0228|TWO_SIDED|95.0|-24.0|-3.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||-3.3|-24.0|0.0228
71896133|NCT01855789|143314245|SUPERIORITY||Low DAS28 Rate Difference|-5.4||||0.3665|TWO_SIDED|95.0|-16.3|5.4|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>=2.6 to \<=3.2), baseline weight-by-dosing group (\<80 kg q2w, \<80 kg qw, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw), participant anti-TNF exposure (Yes/No).||5.4|-16.3|0.3665
71845185|NCT05485805|143204291|OTHER||Geometric LS means|-2.225|||=|0.159|TWO_SIDED|95.0|-5.327|0.877|||ANCOVA|||0-8 hours post-dose||0.877|-5.327|= 0.159
71845186|NCT05485805|143204291|OTHER||Geometric LS means|0.002|||=|0.998|TWO_SIDED|95.0|-1.792|1.795|||ANCOVA|||0-8 hours post-dose||1.795|-1.792|= 0.998
71845187|NCT05485805|143204291|OTHER||Geometric LS means|14.298|||<|0.001|TWO_SIDED|95.0|11.787|16.809|||ANCOVA|||0-8 hours post-dose||16.809|11.787|< 0.001
71845188|NCT05485805|143204291|OTHER||Geometric LS means|9.673|||<|0.001|TWO_SIDED|95.0|7.12|12.226|||ANCOVA|||0-8 hours post-dose||12.226|7.12|< 0.001
71845189|NCT05485805|143204291|OTHER||Geometric LS means|11.9|||<|0.001|TWO_SIDED|95.0|9.387|14.413|||ANCOVA|||0-8 hours post-dose||14.413|9.387|< 0.001
71845190|NCT05485805|143204291|OTHER||Geometric LS means|12.073|||<|0.001|TWO_SIDED|95.0|9.523|14.623|||ANCOVA|||0-8 hours post-dose||14.623|9.523|< 0.001
71845191|NCT05485805|143204291|OTHER||Geometric LS means|9.675|||<|0.001|TWO_SIDED|95.0|7.123|12.227|||ANCOVA|||0-8 hours post-dose||12.227|7.123|< 0.001
71845192|NCT05485805|143204291|OTHER||Geometric LS means|-2.949|||=|0.043|TWO_SIDED|95.0|-5.803|-0.095|||ANCOVA|||0-12 hours post-dose||-0.095|-5.803|= 0.043
71845193|NCT05485805|143204291|OTHER||Geometric LS means|3.694|||=|0.011|TWO_SIDED|95.0|0.837|6.55|||ANCOVA|||0-12 hours post-dose||6.55|0.837|= 0.011
71845194|NCT05485805|143204291|OTHER||Geometric LS means|16.504|||<|0.001|TWO_SIDED|95.0|12.49|20.517|||ANCOVA|||0-12 hours post-dose||20.517|12.49|< 0.001
71845195|NCT05485805|143204291|OTHER||Geometric LS means|-3.437|||=|0.173|TWO_SIDED|95.0|-8.389|1.515|||ANCOVA|||0-12 hours post-dose||1.515|-8.389|= 0.173
71845196|NCT05485805|143204291|OTHER||Geometric LS means|0.744|||=|0.61|TWO_SIDED|95.0|-2.119|3.608|||ANCOVA|||0-12 hours post-dose||3.608|-2.119|= 0.61
71845197|NCT05485805|143204291|OTHER||Geometric LS means|20.197|||<|0.001|TWO_SIDED|95.0|16.189|24.206|||ANCOVA|||0-12 hours post-dose||24.206|16.189|< 0.001
71845198|NCT05485805|143204291|OTHER||Geometric LS means|13.067|||<|0.001|TWO_SIDED|95.0|8.992|17.143|||ANCOVA|||0-12 hours post-dose||17.143|8.992|< 0.001
71845199|NCT05485805|143204291|OTHER||Geometric LS means|17.248|||<|0.001|TWO_SIDED|95.0|13.236|21.261|||ANCOVA|||0-12 hours post-dose||21.261|13.236|< 0.001
71845200|NCT05485805|143204291|OTHER||Geometric LS means|16.761|||<|0.001|TWO_SIDED|95.0|12.69|20.831|||ANCOVA|||0-12 hours post-dose||20.831|12.69|< 0.001
71845201|NCT05485805|143204291|OTHER||Geometric LS means|13.812|||<|0.001|TWO_SIDED|95.0|9.738|17.886|||ANCOVA|||0-12 hours post-dose||17.886|9.738|< 0.001
71845202|NCT05485805|143204291|OTHER||Geometric LS means|-2.312|||=|0.473|TWO_SIDED|95.0|-8.635|4.011|||ANCOVA|||0-24 hours post-dose||4.011|-8.635|= 0.473
71845203|NCT05485805|143204291|OTHER||Geometric LS means|27.08|||<|0.001|TWO_SIDED|95.0|18.188|35.973|||ANCOVA|||0-24 hours post-dose||35.973|18.188|< 0.001
71845204|NCT05485805|143204291|OTHER||Geometric LS means|-6.928|||=|0.215|TWO_SIDED|95.0|-17.9|4.044|||ANCOVA|||0-24 hours post-dose||4.044|-17.9|= 0.215
71845205|NCT05485805|143204291|OTHER||Geometric LS means|2.468|||=|0.445|TWO_SIDED|95.0|-3.876|8.813|||ANCOVA|||0-24 hours post-dose||8.813|-3.876|= 0.445
71845206|NCT05485805|143204291|OTHER||Geometric LS means|20.152|||<|0.001|TWO_SIDED|95.0|11.122|29.183|||ANCOVA|||0-24 hours post-dose||29.183|11.122|< 0.001
71845207|NCT05485805|143204291|OTHER||Geometric LS means|24.933|||<|0.001|TWO_SIDED|95.0|15.914|33.952|||ANCOVA|||0-24 hours post-dose||33.952|15.914|< 0.001
71845208|NCT05485805|143204291|OTHER||Geometric LS means|22.621|||<|0.001|TWO_SIDED|95.0|13.594|31.648|||ANCOVA|||0-24 hours post-dose||31.648|13.594|< 0.001
71845209|NCT05485805|143204292|OTHER||||||=|0.963|||||||ANCOVA|||||||= 0.963
71845210|NCT05485805|143204292|OTHER||||||=|0.118|||||||ANCOVA|||||||= 0.118
71845211|NCT05485805|143204292|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845212|NCT05485805|143204292|OTHER||||||=|0.244|||||||ANCOVA|||||||= 0.244
71845213|NCT05485805|143204292|OTHER||||||=|0.139|||||||ANCOVA|||||||= 0.139
71845214|NCT05485805|143204292|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71676970|NCT03854370|142872222|SUPERIORITY|||||||0.59|||||||Chi-squared|||comparison of all four groups prior to surgical scrub||||.59
71812896|NCT01678131|143128325|SUPERIORITY_OR_OTHER_LEGACY||Posterior Percentage Probability|100.0||||||||||||||The posterior percentage probability of the true success rate of the FNA procedure for the 3 combined treatment groups (n=29) was determined by a Bayesian calculation, using a Jeffrey's prior distribution (i.e. Beta \[0.5,0.5\]) on the true success rate. Neither P-values, nor confidence intervals are estimated in this analysis. The primary hypothesis was met if the posterior percentage probability was \> 80% that the true success rate is at least 60%.||||
71812897|NCT01544998|143128395|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.26
71812898|NCT01544998|143128396|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.90
71812899|NCT01544998|143128397|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||0.003
71812900|NCT01544998|143128398|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||0.14
71812901|NCT01544998|143128399|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
71812902|NCT01544998|143128400|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.||||<0.001
71812903|NCT00514683|143128404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.052||0.853|TWO_SIDED|95.0|-0.086|0.118||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.118|-0.086|0.8530
71812904|NCT00514683|143128404|SUPERIORITY_OR_OTHER|||||||0.7558||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.7558
71812905|NCT00514683|143128404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.792|TWO_SIDED|95.0|-0.119|0.08||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.080|-0.119|0.7920
71812906|NCT00514683|143128404|SUPERIORITY_OR_OTHER|||||||0.6991||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.6991
71812907|NCT00514683|143128404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.051||0.853|TWO_SIDED|95.0|-0.071|0.128||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.128|-0.071|0.8530
71812908|NCT00514683|143128404|SUPERIORITY_OR_OTHER|||||||0.5736||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.5736
71812909|NCT00514683|143128404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.053||0.0639|TWO_SIDED|95.0|0.027|0.235||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.235|0.027|0.0639
71812910|NCT00514683|143128404|SUPERIORITY_OR_OTHER|||||||0.0136||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment\*time, gender\*height, gender\*age and random terms for patient effect, patient\*time.||||||0.0136
71812911|NCT00514683|143128405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.43|STANDARD_ERROR_OF_MEAN|1.312||0.2774|TWO_SIDED|95.0|-1.15|4.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.01|-1.15|0.2774
71812912|NCT00514683|143128405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|1.312||0.4014|TWO_SIDED|95.0|-1.48|3.68|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.68|-1.48|0.4014
71812913|NCT00514683|143128405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|1.324||0.0314|TWO_SIDED|95.0|0.26|5.46|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.46|0.26|0.0314
71845215|NCT05485805|143204292|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845216|NCT05485805|143204292|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845217|NCT05485805|143204292|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845218|NCT05485805|143204292|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845219|NCT05485805|143204294|OTHER||||||=|0.647|||||||ANCOVA|||||||= 0.647
71845220|NCT05485805|143204294|OTHER||||||=|0.714|||||||ANCOVA|||||||= 0.714
71845221|NCT05485805|143204294|OTHER||||||=|0.065|||||||ANCOVA|||||||= 0.065
71845222|NCT05485805|143204294|OTHER||||||=|0.742|||||||ANCOVA|||||||= 0.742
71845223|NCT05485805|143204294|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845224|NCT05485805|143204294|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845225|NCT05485805|143204294|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845226|NCT05485805|143204294|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845227|NCT05485805|143204294|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845228|NCT05485805|143204295|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
71845229|NCT05485805|143204295|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
71845230|NCT05485805|143204295|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845231|NCT05485805|143204295|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
71845232|NCT05485805|143204295|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71676971|NCT03854370|142872222|SUPERIORITY|||||||0.05|||||||Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||.05
71676972|NCT03854370|142872222|SUPERIORITY|||||||0.13|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine post surgical scrub||||.13
71676973|NCT03854370|142872222|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
71812914|NCT00514683|143128405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|1.319||0.0002|TWO_SIDED|95.0|2.37|7.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.56|2.37|0.0002
71812915|NCT00514683|143128406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.046||0.3644|TWO_SIDED|95.0|-0.05|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.05|0.3644
71812916|NCT00514683|143128406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.046||0.4525|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.13|-0.06|0.4525
71812917|NCT00514683|143128406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0471|TWO_SIDED|95.0|0.0|0.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.18|0.00|0.0471
71812918|NCT00514683|143128406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.046||0.0004|TWO_SIDED|95.0|0.08|0.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.26|0.08|0.0004
71812919|NCT00514683|143128407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|1.702||0.592|TWO_SIDED|95.0|-2.43|4.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.26|-2.43|0.5920
71812920|NCT00514683|143128407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.702||0.6155|TWO_SIDED|95.0|-2.49|4.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.20|-2.49|0.6155
71812921|NCT00514683|143128407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81|STANDARD_ERROR_OF_MEAN|1.716||0.0271|TWO_SIDED|95.0|0.43|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.43|0.0271
71812922|NCT00514683|143128407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.47|STANDARD_ERROR_OF_MEAN|1.71||0.0015|TWO_SIDED|95.0|2.11|8.83|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.83|2.11|0.0015
71676974|NCT03854370|142872223|SUPERIORITY|||||||0.45|||||||Chi-squared|||Comparison of all four groups prior to surgical scrub||||0.45
71812923|NCT00514683|143128408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|1.692||0.5601|TWO_SIDED|95.0|-2.34|4.31||ANCOVA with fixed terms for treatment, baseline, region.|ANCOVA||Mean difference to placebo is calculated. Negative change indicates worsening.|||4.31|-2.34|0.5601
71812924|NCT00514683|143128408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.694||0.6366|TWO_SIDED|95.0|-2.53|4.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.13|-2.53|0.6366
71812925|NCT00514683|143128408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|1.702||0.0246|TWO_SIDED|95.0|0.49|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||7.18|0.49|0.0246
71845233|NCT05485805|143204295|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71812926|NCT00514683|143128408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.44|STANDARD_ERROR_OF_MEAN|1.7||0.0015|TWO_SIDED|95.0|2.1|8.78|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||8.78|2.10|0.0015
71812927|NCT00514683|143128409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||0.7543|TWO_SIDED|95.0|0.506|1.637|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.637|0.506|0.7543
71812928|NCT00514683|143128409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.6704|TWO_SIDED|95.0|0.631|2.045|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.045|0.631|0.6704
71845234|NCT05485805|143204295|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845235|NCT05485805|143204295|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845236|NCT05485805|143204295|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845237|NCT05485805|143204296|OTHER||||||=|0.162|||||||ANCOVA|||||||= 0.162
71845238|NCT05485805|143204296|OTHER||||||=|0.319|||||||ANCOVA|||||||= 0.319
71896134|NCT01855789|143314246|SUPERIORITY||Estimated Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.21|0.68|||||TCZ + PBO minus TCZ + MTX|ANCOVA model included Week 24 bone erosion as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (\<2.6, \>/=2.6 to \</=3.2), participant anti-TNF exposure (Yes/No), baseline weight-by-dosing group (\<80 kg q2w, 80-\<100 kg q2w, 80-\<100 kg qw, \>=100 kg qw).||0.68|-0.21|
71812929|NCT00514683|143128409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.657||||0.1649|TWO_SIDED|95.0|0.363|1.189|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.189|0.363|0.1649
71812930|NCT00514683|143128409|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.415||||0.0041|TWO_SIDED|95.0|0.227|0.757|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.757|0.227|0.0041
71812931|NCT00514683|143128410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.5882|TWO_SIDED|95.0|0.526|3.102|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||3.102|0.526|0.5882
71812932|NCT00514683|143128410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.0653|TWO_SIDED|95.0|0.078|1.081|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.081|0.078|0.0653
71896341|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|2.284||||0.143|TWO_SIDED|95.0|0.757|6.895||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.895|0.757|0.143
71812933|NCT00514683|143128410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.0847|TWO_SIDED|95.0|0.106|1.154|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.154|0.106|0.0847
71812934|NCT00514683|143128410|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.732||||0.5383|TWO_SIDED|95.0|0.271|1.977|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.|||1.977|0.271|0.5383
71812935|NCT00514683|143128411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.483||0.3658|TWO_SIDED|95.0|-0.51|1.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.39|-0.51|0.3658
71812936|NCT00514683|143128411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.478||0.4956|TWO_SIDED|95.0|-0.61|1.27|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.27|-0.61|0.4956
71812937|NCT00514683|143128411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|0.482||0.0051|TWO_SIDED|95.0|0.41|2.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.31|0.41|0.0051
71812938|NCT00514683|143128411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|0.483||0.0211|TWO_SIDED|95.0|0.17|2.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.07|0.17|0.0211
71845239|NCT05485805|143204296|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845240|NCT05485805|143204296|OTHER||||||=|0.343|||||||ANCOVA|||||||= 0.343
71845241|NCT05485805|143204296|OTHER||||||=|0.772|||||||ANCOVA|||||||= 0.772
71845242|NCT05485805|143204296|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845243|NCT05485805|143204296|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845244|NCT05485805|143204296|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845245|NCT05485805|143204296|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845246|NCT05485805|143204296|OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71845247|NCT05485805|143204299|OTHER||geometric LS mean square|-0.14|||=|0.334|TWO_SIDED|95.0|-0.44|0.15|||ANCOVA|||||0.15|-0.44|= 0.334
71845248|NCT05485805|143204299|OTHER||geometric LS mean square|0.04|||=|0.783|TWO_SIDED|95.0|-0.25|0.33|||ANCOVA|||||0.33|-0.25|= 0.783
71845249|NCT05485805|143204299|OTHER||geometric LS mean square|-0.08|||=|0.687|TWO_SIDED|95.0|-0.5|0.33|||ANCOVA|||||0.33|-0.5|= 0.687
71845250|NCT05485805|143204299|OTHER||geometric LS mean square|-0.02|||=|0.927|TWO_SIDED|95.0|-0.53|0.49|||ANCOVA|||||0.49|-0.53|= 0.927
71845251|NCT05485805|143204299|OTHER||geometric LS mean square|-0.1|||=|0.492|TWO_SIDED|95.0|-0.4|0.19|||ANCOVA|||||0.19|-0.4|= 0.492
71845252|NCT05485805|143204299|OTHER||geometric LS mean square|-0.04|||=|0.836|TWO_SIDED|95.0|-0.46|0.37|||ANCOVA|||||0.37|-0.46|= 0.836
71812939|NCT00514683|143128412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.428||||0.1021|TWO_SIDED|95.0|0.155|1.184|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.184|0.155|0.1021
71812940|NCT00514683|143128412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.682||||0.4318|TWO_SIDED|95.0|0.262|1.773|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.773|0.262|0.4318
71812941|NCT00514683|143128412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.412||||0.0934|TWO_SIDED|95.0|0.146|1.161|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.161|0.146|0.0934
71812942|NCT00514683|143128412|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.313||||0.0317|TWO_SIDED|95.0|0.108|0.903|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||0.903|0.108|0.0317
71812943|NCT00514683|143128413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|2.33||0.6443|TWO_SIDED|95.0|-5.66|3.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.51|-5.66|0.6443
71812944|NCT00514683|143128413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|2.28||0.5656|TWO_SIDED|95.0|-5.8|3.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||3.18|-5.80|0.5656
71812945|NCT00514683|143128413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|2.24||0.9181|TWO_SIDED|95.0|-4.18|4.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.64|-4.18|0.9181
71812946|NCT00514683|143128413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|2.387||0.697|TWO_SIDED|95.0|-3.77|5.63|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.63|-3.77|0.6970
71812947|NCT00514683|143128414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|2.49||0.9811|TWO_SIDED|95.0|-4.84|4.96|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||4.96|-4.84|0.9811
71812948|NCT00514683|143128414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01|STANDARD_ERROR_OF_MEAN|2.412||0.6772|TWO_SIDED|95.0|-3.74|5.75|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.75|-3.74|0.6772
71812949|NCT00514683|143128414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|2.379||0.8631|TWO_SIDED|95.0|-4.27|5.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||5.09|-4.27|0.8631
71812950|NCT00514683|143128414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|2.523||0.5942|TWO_SIDED|95.0|-3.62|6.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||6.31|-3.62|0.5942
71812951|NCT00514683|143128415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.715||0.2716|TWO_SIDED|95.0|-0.62|2.19|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||2.19|-0.62|0.2716
71812952|NCT00514683|143128415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.696||0.7871|TWO_SIDED|95.0|-1.18|1.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.56|-1.18|0.7871
71812953|NCT00514683|143128415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.685||0.8721|TWO_SIDED|95.0|-1.46|1.24|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.24|-1.46|0.8721
71812954|NCT00514683|143128415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.734||0.8523|TWO_SIDED|95.0|-1.58|1.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||1.31|-1.58|0.8523
71676975|NCT03854370|142872223|SUPERIORITY|||||||0.99||||||all groups were negative for cultures|Fisher Exact|||Comparison of baby shampoo versus iodine post surgical scrub||||0.99
71812955|NCT00514683|143128416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.7997|TWO_SIDED|95.0|0.549|2.175|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.175|0.549|0.7997
71812956|NCT00514683|143128416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.916||||0.7989|TWO_SIDED|95.0|0.467|1.797|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.797|0.467|0.7989
71812957|NCT00514683|143128416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4596|TWO_SIDED|95.0|0.403|1.508|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.508|0.403|0.4596
71812958|NCT00514683|143128416|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.665||||0.2548|TWO_SIDED|95.0|0.33|1.341|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.341|0.330|0.2548
71812959|NCT00514683|143128417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.051||||0.8887|TWO_SIDED|95.0|0.521|2.122|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.122|0.521|0.8887
71812960|NCT00514683|143128417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.216||||0.5758|TWO_SIDED|95.0|0.613|2.41|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.410|0.613|0.5758
71845253|NCT05485805|143204299|OTHER||geometric LS mean square|-0.11|||=|0.611|TWO_SIDED|95.0|-0.53|0.31|||ANCOVA|||||0.31|-0.53|= 0.611
71845254|NCT05485805|143204299|OTHER||geometric LS mean square|-0.19|||=|0.371|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||||0.22|-0.6|= 0.371
71812961|NCT00514683|143128417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.993||||0.9829|TWO_SIDED|95.0|0.506|1.949|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.949|0.506|0.9829
71812962|NCT00514683|143128417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.972||||0.9375|TWO_SIDED|95.0|0.476|1.985|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.985|0.476|0.9375
71812963|NCT00514683|143128418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.1456||0.4998|TWO_SIDED|95.0|-0.188|0.385|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.385|-0.188|0.4998
71812964|NCT00514683|143128418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.1399||0.2679|TWO_SIDED|95.0|-0.43|0.12|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.120|-0.430|0.2679
71812965|NCT00514683|143128418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.5678|TWO_SIDED|95.0|-0.355|0.195|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.195|-0.355|0.5678
71812966|NCT00514683|143128418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.121|STANDARD_ERROR_OF_MEAN|0.1448||0.4053|TWO_SIDED|95.0|-0.406|0.164|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.164|-0.406|0.4053
71812967|NCT00514683|143128419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.892||||0.7307|TWO_SIDED|95.0|0.465|1.71|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.710|0.465|0.7307
71812968|NCT00514683|143128419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.317||||0.3869|TWO_SIDED|95.0|0.706|2.458|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||2.458|0.706|0.3869
71812969|NCT00514683|143128419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.931||||0.8237|TWO_SIDED|95.0|0.498|1.741|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||1.741|0.498|0.8237
71812970|NCT00514683|143128419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.676||||0.1177|TWO_SIDED|95.0|0.878|3.202|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.|||3.202|0.878|0.1177
71676976|NCT03854370|142872223|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chlorhexidine versus iodine at post surgical scrub||||0.99
71812971|NCT00514683|143128420|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-11.24|STANDARD_ERROR_OF_MEAN|17.089||0.5111|TWO_SIDED|95.0|-44.86|22.37|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||22.37|-44.86|0.5111
71812972|NCT00514683|143128420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|16.234||0.4176|TWO_SIDED|95.0|-45.11|18.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||18.76|-45.11|0.4176
71812973|NCT00514683|143128420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|16.506||0.9454|TWO_SIDED|95.0|-33.6|31.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||31.34|-33.60|0.9454
71812974|NCT00514683|143128420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32|STANDARD_ERROR_OF_MEAN|16.98||0.7101|TWO_SIDED|95.0|-27.08|39.72|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||39.72|-27.08|0.7101
71845255|NCT05485805|143204299|OTHER||geometric LS mean square|-0.07|||=|0.752|TWO_SIDED|95.0|-0.49|0.35|||ANCOVA|||||0.35|-0.49|= 0.752
71845256|NCT05485805|143204299|OTHER||geometric LS mean square|-0.21|||=|0.321|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||||0.21|-0.63|= 0.321
71812975|NCT00514683|143128421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.2271||0.809|TWO_SIDED|95.0|-0.392|0.502|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.502|-0.392|0.8090
71812976|NCT00514683|143128421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182|STANDARD_ERROR_OF_MEAN|0.2158||0.3995|TWO_SIDED|95.0|-0.606|0.242|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.242|-0.606|0.3995
71812977|NCT00514683|143128421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.2193||0.8822|TWO_SIDED|95.0|-0.399|0.464|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.464|-0.399|0.8822
71812978|NCT00514683|143128421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.2257||0.5338|TWO_SIDED|95.0|-0.584|0.303|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.303|-0.584|0.5338
71812979|NCT00514683|143128422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112|STANDARD_ERROR_OF_MEAN|0.3272||0.7329|TWO_SIDED|95.0|-0.532|0.755|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.755|-0.532|0.7329
71812980|NCT00514683|143128422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.3109||0.8009|TWO_SIDED|95.0|-0.69|0.533|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.533|-0.690|0.8009
71812981|NCT00514683|143128422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3159||0.6358|TWO_SIDED|95.0|-0.771|0.472|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.472|-0.771|0.6358
71812982|NCT00514683|143128422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.3252||0.3064|TWO_SIDED|95.0|-0.973|0.307|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.307|-0.973|0.3064
71812983|NCT00514683|143128423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.9646|TWO_SIDED|95.0|0.54|1.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.906|0.540|0.9646
71812984|NCT00514683|143128423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.994||||0.985|TWO_SIDED|95.0|0.536|1.844|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||1.844|0.536|0.9850
71812985|NCT00514683|143128423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.7136|TWO_SIDED|95.0|0.604|2.089|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.089|0.604|0.7136
71812986|NCT00514683|143128423|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.551||||0.1705|TWO_SIDED|95.0|0.828|2.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.|||2.906|0.828|0.1705
71812987|NCT00514683|143128424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|0.68||0.0479|TWO_SIDED|95.0|-2.69|-0.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.01|-2.69|0.0479
71812988|NCT00514683|143128424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.68||0.0685|TWO_SIDED|95.0|-2.58|0.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||0.09|-2.58|0.0685
71812989|NCT00514683|143128424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.684||0.0099|TWO_SIDED|95.0|-3.12|-0.43|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.43|-3.12|0.0099
71812990|NCT00514683|143128424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.683||0.0152|TWO_SIDED|95.0|-3.01|-0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.|||-0.32|-3.01|0.0152
71812991|NCT00514683|143128425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|2.253||0.725|TWO_SIDED|95.0|-5.22|3.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.64|-5.22|0.7250
71812992|NCT00514683|143128425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.28|STANDARD_ERROR_OF_MEAN|2.213||0.1389|TWO_SIDED|95.0|-7.63|1.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.07|-7.63|0.1389
71812993|NCT00514683|143128425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|2.221||0.0741|TWO_SIDED|95.0|-8.35|0.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.39|-8.35|0.0741
71812994|NCT00514683|143128425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|STANDARD_ERROR_OF_MEAN|2.262||0.0071|TWO_SIDED|95.0|-10.57|-1.67|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-1.67|-10.57|0.0071
71812995|NCT00514683|143128426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.06|STANDARD_ERROR_OF_MEAN|3.183||0.337|TWO_SIDED|95.0|-9.32|3.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||3.20|-9.32|0.3370
71812996|NCT00514683|143128426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|3.126||0.1659|TWO_SIDED|95.0|-10.49|1.81|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.81|-10.49|0.1659
71812997|NCT00514683|143128426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.12|STANDARD_ERROR_OF_MEAN|3.138||0.1897|TWO_SIDED|95.0|-10.29|2.05|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.05|-10.29|0.1897
71812998|NCT00514683|143128426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|3.184||0.0028|TWO_SIDED|95.0|-15.86|-3.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-3.34|-15.86|0.0028
71896135|NCT02858193|143314295|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.|Geometric means ratio|111.63||||0.0482|TWO_SIDED|94.12|100.51|123.99||"treatment p-value reported"|ANOVA||Estimated value and limits are expressed in %|||123.99|100.51|0.0482
71896136|NCT02858193|143314297|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies|geometric means ratio|109.41||||0.0002|TWO_SIDED|94.12|104.93|114.07||"treatment p-value is reported"|ANOVA||Estimated value and limits are expressed in%|||114.07|104.93|0.0002
71896137|NCT02858193|143314298|EQUIVALENCE|Acceptance criterion for bioequivalence was that 94.12% confidence intervals (CIs) of the T/R ratios of the geometric means of the analysed PK parameters were within the 80.00-125.00% range according to the current guidelines for bioequivalence studies.||||||0.593|||||||Friedman|||||||0.5930
71896138|NCT01582282|143314302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.64||||0.028|||||||ANCOVA|||||||0.028
71896139|NCT01582282|143314302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|40.72||||0.009|||||||ANCOVA|||||||0.009
71896140|NCT01582282|143314303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.013|||||||ANCOVA|||||||0.013
71812999|NCT00514683|143128427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.586||0.8458|TWO_SIDED|95.0|-5.59|4.58|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.58|-5.59|0.8458
71676977|NCT03854370|142872223|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post surgical scrub||||0.99
71813000|NCT00514683|143128427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|2.54||0.3286|TWO_SIDED|95.0|-7.48|2.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||2.51|-7.48|0.3286
71813001|NCT00514683|143128427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|2.548||0.1799|TWO_SIDED|95.0|-8.43|1.59|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||1.59|-8.43|0.1799
71813002|NCT00514683|143128427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.35|STANDARD_ERROR_OF_MEAN|2.597||0.0948|TWO_SIDED|95.0|-9.46|0.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.76|-9.46|0.0948
71813003|NCT00514683|143128428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|2.484||0.9708|TWO_SIDED|95.0|-4.98|4.79|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||4.79|-4.98|0.9708
71813004|NCT00514683|143128428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|2.44||0.1069|TWO_SIDED|95.0|-8.74|0.85|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.85|-8.74|0.1069
71896141|NCT01582282|143314303|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.003|||||||ANCOVA|||||||0.003
71896142|NCT01582282|143314304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.808|||||||ANCOVA|||||||0.808
71896143|NCT01582282|143314304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.328|||||||ANCOVA|||||||0.328
71896144|NCT01582282|143314305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1||||0.508|||||||ANCOVA|||||||0.508
71896145|NCT01582282|143314305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.962|||||||ANCOVA|||||||0.962
71896146|NCT01582282|143314306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.84||||0.363|||||||ANCOVA|||||||0.363
71896147|NCT01582282|143314306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.978|||||||ANCOVA|||||||0.978
71896148|NCT01582282|143314307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.14||||0.785|||||||ANCOVA|||||||0.785
71896149|NCT01582282|143314307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.45||||0.811|||||||ANCOVA|||||||0.811
71896150|NCT00112151|143314311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
71896151|NCT00112151|143314311|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.025|TWO_SIDED|||||A one-sided P-value of \<0.025 was used to define statistical significance.|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.||||<0.025
71896152|NCT00112151|143314312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.||||<0.05
71896153|NCT00112151|143314312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
71676978|NCT03854370|142872224|SUPERIORITY|||||||0.61|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.61
71813005|NCT00514683|143128428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.49|STANDARD_ERROR_OF_MEAN|2.453||0.0682|TWO_SIDED|95.0|-9.31|0.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.34|-9.31|0.0682
71813006|NCT00514683|143128428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.16|STANDARD_ERROR_OF_MEAN|2.494||0.0043|TWO_SIDED|95.0|-12.06|-2.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||-2.26|-12.06|0.0043
71813007|NCT00514683|143128429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.2698|TWO_SIDED|95.0|0.72|3.31|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||3.31|0.72|0.2698
71813008|NCT00514683|143128429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.0891|TWO_SIDED|95.0|0.9|4.01|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.01|0.90|0.0891
71813009|NCT00514683|143128429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.0069|TWO_SIDED|95.0|1.29|5.66|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||5.66|1.29|0.0069
71813010|NCT00514683|143128429|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0341|TWO_SIDED|95.0|1.05|4.61|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.|||4.61|1.05|0.0341
71813011|NCT00514683|143128430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.1015||0.8288|TWO_SIDED|95.0|-0.178|0.222|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.222|-0.178|0.8288
71813012|NCT00514683|143128430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.0974||0.1506|TWO_SIDED|95.0|-0.051|0.332|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.332|-0.051|0.1506
71813013|NCT00514683|143128430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.0977||0.1059|TWO_SIDED|95.0|-0.034|0.351|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.351|-0.034|0.1059
71813014|NCT00514683|143128430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|STANDARD_ERROR_OF_MEAN|0.1008||0.0004|TWO_SIDED|95.0|0.16|0.556|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.556|0.160|0.0004
71813015|NCT00514683|143128431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.068||0.7789|TWO_SIDED|95.0|-0.153|0.115|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.115|-0.153|0.7789
71813016|NCT00514683|143128431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.0652||0.3149|TWO_SIDED|95.0|-0.063|0.194|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.194|-0.063|0.3149
71813017|NCT00514683|143128431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.0654||0.7062|TWO_SIDED|95.0|-0.104|0.153|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.153|-0.104|0.7062
71813018|NCT00514683|143128431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|STANDARD_ERROR_OF_MEAN|0.0675||0.0703|TWO_SIDED|95.0|-0.01|0.255|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.|||0.255|-0.010|0.0703
71896154|NCT00112151|143314313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.||||<0.05
71813019|NCT00514683|143128432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.0884||0.4792|TWO_SIDED|95.0|-0.111|0.236|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.236|-0.111|0.4792
71813020|NCT00514683|143128432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.0839||0.2221|TWO_SIDED|95.0|-0.062|0.268|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.268|-0.062|0.2221
71813021|NCT00514683|143128432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.0843||0.151|TWO_SIDED|95.0|-0.044|0.287|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.287|-0.044|0.1510
71813022|NCT00514683|143128432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337|STANDARD_ERROR_OF_MEAN|0.0874||0.0001|TWO_SIDED|95.0|0.165|0.509|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.509|0.165|0.0001
71896155|NCT00112151|143314313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.||||<0.05
71896156|NCT00112151|143314314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.||||<0.05
71896157|NCT00112151|143314314|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.||||<0.05
71676979|NCT03854370|142872224|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
71676980|NCT03854370|142872224|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
71676981|NCT03854370|142872225|SUPERIORITY|||||||0.32|||||||Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.32
71676982|NCT03854370|142872225|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Comparison of chlorhexidine versus iodine at post procedure||||0.99
71676983|NCT03854370|142872225|SUPERIORITY|||||||0.5|||||||Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.50
71845257|NCT01586104|143204307|OTHER|With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.|||||<|0.0125||||||The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.|Bonferroni corrected at p<0.0125|||Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.|Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).|||<0.0125
71845258|NCT04218357|143204310|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||GEE|Generalized Estimating Equation with standard errors, and an unstructured correlation matrix with medication and time as within-subject factors.||All outcomes were assessed in real-time in the laboratory testing probenecid compared to placebo condition during the alcohol administration procedure.||||0.05
71845259|NCT01958021|143204362|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.556||||3.29e-06|TWO_SIDED|95.0|0.429|0.72|||Log Rank|||||0.720|0.429|0.00000329
71676984|NCT03854370|142872226|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of baby shampoo versus iodine at post procedure||||0.99
71676985|NCT03854370|142872226|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||comparison of chlorhexidine versus iodine at post procedure||||0.99
71676986|NCT03854370|142872226|SUPERIORITY|||||||0.99||||||All groups had negative cultures|Fisher Exact|||Comparison of chloroxynel versus iodine at post procedure||||0.99
71676987|NCT01608087|142872259|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|96.58|||||TWO_SIDED|93.93|88.54|105.35|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|105.35|88.54|
71845260|NCT01958021|143204363|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.004|TWO_SIDED|95.0|0.628|0.932|||Log Rank|||||0.932|0.628|0.004
71676988|NCT01608087|142872259|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.68|||||TWO_SIDED|93.93|83.5|100.65|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.65|83.50|
71676989|NCT01608087|142872259|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|94.92|||||TWO_SIDED|93.93|87.14|103.4|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|103.40|87.14|
71676990|NCT01608087|142872260|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|98.96|||||TWO_SIDED|90.0|90.97|107.64|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|107.64|90.97|
71813023|NCT00514683|143128433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.0609||0.1129|TWO_SIDED|95.0|-0.023|0.217|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.217|-0.023|0.1129
71813024|NCT00514683|143128433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.0584||0.1498|TWO_SIDED|95.0|-0.031|0.199|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.199|-0.031|0.1498
71845261|NCT01958021|143204364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.000155|||||||Cochran-Mantel-Haenszel|||||||0.000155
71845262|NCT01958021|143204365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
71845263|NCT04640974|143204370|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71845264|NCT04640974|143204371|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71845265|NCT04640974|143204372|OTHER||||||<|0.0001||||||P-Value was calculated|ANOVA|||||||<0.0001
71845266|NCT05886777|143204379|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.99|||||TWO_SIDED|97.5|0.782|1.249|||||GMRs and 2-sided confidence intervals (CIs) were calculated by exponentiating mean differences of logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.249|0.782|
71845267|NCT05886777|143204380|NON_INFERIORITY|Null hypothesis(H0) to assess noninferiority with respect to RSVpreF was evaluated by following hypothesis for both RSV A and B as measured by NT: H0: ln(μ1)- ln(μ4) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, ln(μ1), ln(μ4) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 4, respectively.|Geometric mean ratio|0.9|||||TWO_SIDED|97.5|0.697|1.162|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).|||1.162|0.697|
71845268|NCT05886777|143204381|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.84|||||TWO_SIDED|97.5|0.605|1.168|||||GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and corresponding CIs (based on the Student t distribution).|||1.168|0.605|
71845269|NCT05886777|143204382|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to BNT162b2 was evaluated by following hypothesis for both SARS-CoV-2 Omicron BA.4/BA.5 strain and reference strain as measured by NT: H0: ln(μ1)- ln(μ3) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ3) are natural log of geometric mean of NT 1 month after vaccination for Group 1, 3, respectively.|Geometric mean ratio|0.79|||||TWO_SIDED|97.5|0.618|1.014|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).|||1.014|0.618|
71845270|NCT05886777|143204383|NON_INFERIORITY|Null hypothesis (H0) to assess noninferiority with respect to QIV was evaluated by following hypothesis for each of 4 strains included in QIV as measured by HAI titer: H0: ln(μ1)- ln(μ5) \<= ln(0.5) where ln(0.5) corresponds to a 2-fold margin for noninferiority, and ln(μ1) and ln(μ5) are natural log of the geometric mean of HAI titers 1 month after vaccination for Group 1,5, respectively.|Geometric mean ratio|1.06|||||TWO_SIDED|97.5|0.785|1.423|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).|||1.423|0.785|
71896158|NCT00112151|143314315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
71896159|NCT00112151|143314315|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
71896160|NCT00112151|143314316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.||||<0.05
71896161|NCT00112151|143314316|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.||||<0.05
71896162|NCT02495077|143314321|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.099|TWO_SIDED|95.0|-10.73|0.93|||Mixed Models Analysis|||Mean eGFR of the two treatment groups was compared. The p-value, estimated month 24 eGFR within each treatment group, estimate of the treatment group difference, and estimated 95% confidence intervals result from a repeated measures mixed model using available eGFR data from months 1, 3, 6, 12, 18, and 24 to compare the experimental group to the control group. Random effects for the intercept and eGFR collection day were utilized in the model.||0.93|-10.73|0.099
71896163|NCT02495077|143314322|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71896164|NCT02495077|143314323|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71896165|NCT02495077|143314325|SUPERIORITY|||||||0.746|||||||Fisher Exact|||||||0.746
71676991|NCT01608087|142872260|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.67|||||TWO_SIDED|90.0|84.02|100.01|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.01|84.02|
71676992|NCT01608087|142872260|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|92.63|||||TWO_SIDED|90.0|85.18|100.74|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(R1/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|100.74|85.18|
71676993|NCT01608087|142872261|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|101.53|||||TWO_SIDED|90.0|92.74|111.14|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R1) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|111.14|92.74|
71676994|NCT01608087|142872261|EQUIVALENCE|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|93.25|||||TWO_SIDED|90.0|87.12|99.81|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including effects'treatment' and 'weight'.|(T/R2) \* 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.|99.81|87.12|
71813025|NCT00514683|143128433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.0585||0.0632|TWO_SIDED|95.0|-0.006|0.224|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.224|-0.006|0.0632
71813026|NCT00514683|143128433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.0604||0.0009|TWO_SIDED|95.0|0.083|0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.320|0.083|0.0009
71813027|NCT00514683|143128434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.0676||0.6306|TWO_SIDED|95.0|-0.165|0.1|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.100|-0.165|0.6306
71813028|NCT00514683|143128434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.065||0.7426|TWO_SIDED|95.0|-0.149|0.106|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.106|-0.149|0.7426
71813029|NCT00514683|143128434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.0651||0.9209|TWO_SIDED|95.0|-0.134|0.121|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.121|-0.134|0.9209
71813030|NCT00514683|143128434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.0671||0.7701|TWO_SIDED|95.0|-0.112|0.152|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.|||0.152|-0.112|0.7701
71813031|NCT00514683|143128435|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.6671|TWO_SIDED|95.0|0.36|1.93||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.93|0.36|0.6671
71813032|NCT00514683|143128435|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8||||0.5926|TWO_SIDED|95.0|0.34|1.84||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.84|0.34|0.5926
71813033|NCT00514683|143128435|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.1381|TWO_SIDED|95.0|0.18|1.27||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||1.27|0.18|0.1381
71813034|NCT00514683|143128435|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.16||||0.015|TWO_SIDED|95.0|0.03|0.7||Based on the statistic of ln(risk ratio) having a normal distribution N\[0,\[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) \] \]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.|||0.70|0.03|0.0150
71813035|NCT00514683|143128436|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9||||0.8282|TWO_SIDED|95.0|0.347|2.336|||Negative binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||2.336|0.347|0.8282
71813036|NCT00514683|143128436|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.5326|TWO_SIDED|95.0|0.278|1.938|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off-set variable and age, height, gender, region (all effects fixed).|||1.938|0.278|0.5326
71896166|NCT02495077|143314326|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.242
71896167|NCT02495077|143314328|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71896168|NCT02495077|143314329|SUPERIORITY|||||||0.497|||||||Fisher Exact|||||||0.497
71896169|NCT02495077|143314330|SUPERIORITY|||||||0.622|||||||Fisher Exact|||||||0.622
71896170|NCT02495077|143314332|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
71814148|NCT00509236|143130595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||||<0.001
71896348|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|4.929||||0.007|TWO_SIDED|95.0|1.556|15.612||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||15.612|1.556|0.007
71896349|NCT03114969|143314797|SUPERIORITY||Odds Ratio (OR)|1.208||||0.746|TWO_SIDED|95.0|0.385|3.788||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.788|0.385|0.746
71896350|NCT03114969|143314798|SUPERIORITY||Odds Ratio (OR)|1.502||||0.404|TWO_SIDED|95.0|0.578|3.905||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.905|0.578|0.404
71896351|NCT03114969|143314798|SUPERIORITY||Odds Ratio (OR)|1.591||||0.33|TWO_SIDED|95.0|0.625|4.05||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.050|0.625|0.330
71896352|NCT03114969|143314799|SUPERIORITY||Odds Ratio (OR)|1.738||||0.189|TWO_SIDED|95.0|0.761|3.968||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||3.968|0.761|0.189
71896353|NCT03114969|143314799|SUPERIORITY||Odds Ratio (OR)|2.079||||0.086|TWO_SIDED|95.0|0.901|4.799||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.799|0.901|0.086
71896354|NCT03114969|143314799|SUPERIORITY||Odds Ratio (OR)|1.95||||0.082|TWO_SIDED|95.0|0.918|4.142||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.142|0.918|0.082
71896355|NCT03114969|143314799|SUPERIORITY||Odds Ratio (OR)|2.415||||0.018|TWO_SIDED|95.0|1.161|5.024||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.024|1.161|0.018
71896356|NCT03114969|143314800|SUPERIORITY||Odds Ratio (OR)|1.51||||0.472|TWO_SIDED|95.0|0.492|4.633||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.633|0.492|0.472
71896357|NCT03114969|143314800|SUPERIORITY||Odds Ratio (OR)|1.402||||0.553|TWO_SIDED|95.0|0.459|4.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||4.283|0.459|0.553
71896358|NCT03114969|143314801|SUPERIORITY||Odds Ratio (OR)|2.523||||0.052|TWO_SIDED|95.0|0.993|6.407||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.407|0.993|0.052
71896359|NCT03114969|143314801|SUPERIORITY||Odds Ratio (OR)|2.757||||0.029|TWO_SIDED|95.0|1.107|6.862||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.862|1.107|0.029
71896360|NCT03114969|143314802|SUPERIORITY||Odds Ratio (OR)|2.434||||0.024|TWO_SIDED|95.0|1.123|5.276||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.276|1.123|0.024
71677380|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric mean ratio at day 202|0.898|||||TWO_SIDED|95.0|0.622|1.298||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.298|0.622|
71677381|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.451|||||TWO_SIDED|95.0|1.0|2.105||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.105|1.000|
71677382|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.418|||||TWO_SIDED|95.0|0.289|0.603||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.603|0.289|
71677383|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.338|||||TWO_SIDED|95.0|0.235|0.487||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.487|0.235|
71677384|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.808|||||TWO_SIDED|95.0|0.561|1.165||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.165|0.561|
71677385|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.334|||||TWO_SIDED|95.0|0.233|0.479||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.479|0.233|
71677386|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.342|||||TWO_SIDED|95.0|0.237|0.494||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.494|0.237|
71677387|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.553|||||TWO_SIDED|95.0|0.382|0.801||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.801|0.382|
71677388|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.811|||||TWO_SIDED|95.0|0.562|1.169||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.169|0.562|
71882164|NCT02831673|143283262|OTHER||Ratio of geometric means|0.695|||<|0.001|TWO_SIDED|95.0|0.576|0.839|||Mixed Model Repeated Measures||Week 48. Urine B2M/Urine Creatinine|||0.839|0.576|<0.001
71882165|NCT02831673|143283262|OTHER||Ratio of geometric means|1.102||||0.099|TWO_SIDED|95.0|0.982|1.237|||Mixed Model Repeated Measures||Week 24. Urine Phosphate|||1.237|0.982|0.099
71882166|NCT02831673|143283262|OTHER||Ratio of geometric means|0.987||||0.816|TWO_SIDED|95.0|0.886|1.1|||Mixed Model Repeated Measures||Week 48. Urine Phosphate|||1.100|0.886|0.816
71882167|NCT02831673|143283262|OTHER||Ratio of geometric means|0.836|||<|0.001|TWO_SIDED|95.0|0.774|0.904|||Mixed Model Repeated Measures||Week 24. Urine Protein/Creatinine|||0.904|0.774|<0.001
71882168|NCT02831673|143283262|OTHER||Ratio of geometric means|0.829|||<|0.001|TWO_SIDED|95.0|0.773|0.888|||Mixed Model Repeated Measures||Week 48. Urine Protein/Creatinine|||0.888|0.773|<0.001
71896361|NCT03114969|143314802|SUPERIORITY||Odds Ratio (OR)|2.389||||0.035|TWO_SIDED|95.0|1.061|5.376||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.376|1.061|0.035
71677389|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.935|||||TWO_SIDED|95.0|1.347|2.78||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.780|1.347|
71677390|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.8|||||TWO_SIDED|95.0|0.558|1.147||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.147|0.558|
71677391|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.82|||||TWO_SIDED|95.0|0.568|1.184||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.184|0.568|
71677392|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.324|||||TWO_SIDED|95.0|0.915|1.917||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.917|0.915|
71677393|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.388|||||TWO_SIDED|95.0|1.658|3.438||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.438|1.658|
71677394|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.987|||||TWO_SIDED|95.0|0.688|1.416||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.416|0.688|
71677395|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.012|||||TWO_SIDED|95.0|0.701|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.701|
71677396|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.634|||||TWO_SIDED|95.0|1.128|2.366||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.366|1.128|
71677397|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.413|||||TWO_SIDED|95.0|0.288|0.592||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.592|0.288|
71688666|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|3.71||0.1421|TWO_SIDED|90.0|-0.71|11.94|||t-test, 2 sided|||Lung, Right Middle Lobe Ventilation||11.94|-0.71|0.1421
71882169|NCT02831673|143283262|OTHER||Ratio of geometric means|0.871||||0.087|TWO_SIDED|95.0|0.743|1.02|||Mixed Model Repeated Measures||Week 24. Urine RBP 4|||1.020|0.743|0.087
71882170|NCT02831673|143283262|OTHER||Ratio of geometric means|0.748|||<|0.001|TWO_SIDED|95.0|0.644|0.87|||Mixed Model Repeated Measures||Week 48. Urine RBP 4|||0.870|0.644|<0.001
71882171|NCT02831673|143283262|OTHER||Ratio of geometric means|0.828||||0.005|TWO_SIDED|95.0|0.727|0.944|||Mixed Model Repeated Measures||Week 24. Urine RBP 4/Urine Creatinine|||0.944|0.727|0.005
71882172|NCT02831673|143283262|OTHER||Ratio of geometric means|0.765|||<|0.001|TWO_SIDED|95.0|0.677|0.864|||Mixed Model Repeated Measures||Week 48. Urine RBP 4/Urine Creatinine|||0.864|0.677|<0.001
71896362|NCT03114969|143314802|SUPERIORITY||Odds Ratio (OR)|2.889||||0.003|TWO_SIDED|95.0|1.434|5.819||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||5.819|1.434|0.003
71896363|NCT03114969|143314802|SUPERIORITY||Odds Ratio (OR)|2.974||||0.003|TWO_SIDED|95.0|1.461|6.055||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+\[Relvar Ellipta+LAMA\] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.|||6.055|1.461|0.003
71896364|NCT00949650|143314803|SUPERIORITY_OR_OTHER|||||||0.0002||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0002
71896365|NCT00949650|143314803|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.576||||0.0002||95.0|0.426|0.778|||Regression, Cox|Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.|Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.|||0.778|0.426|0.0002
71896366|NCT00949650|143314804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.802|||<|0.0001||95.0|2.855|8.075|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||8.075|2.855|<0.0001
71896367|NCT00949650|143314805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.288||||0.0118||95.0|1.202|4.356|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||4.356|1.202|0.0118
71896368|NCT00949650|143314806|SUPERIORITY_OR_OTHER|||||||0.7916||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.7916
71896369|NCT00949650|143314806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.385||95.0|0.66|1.174|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||1.174|0.660|0.3850
71896370|NCT00949650|143314807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.82|||<|0.0001||95.0|-13.64|-5.99|||ANCOVA|Adjusted for baseline SoD, EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.|||-5.99|-13.64|<0.0001
71896371|NCT00949650|143314810|SUPERIORITY_OR_OTHER|||||||0.0062||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0062
71896372|NCT00949650|143314810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.589||||0.2133||95.0|0.401|0.866|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.866|0.401|0.2133
71896373|NCT00949650|143314811|SUPERIORITY_OR_OTHER|||||||0.0129||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.0129
71896374|NCT00949650|143314811|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.0078||95.0|0.499|0.927|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||0.927|0.499|0.0078
71896375|NCT00949650|143314812|SUPERIORITY_OR_OTHER|||||||0.1882||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank|||||||0.1882
71896376|NCT00949650|143314812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.0427||95.0|0.618|1.104|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR\<1 then favours Afatinib 40 mg.|||1.104|0.618|0.0427
71896377|NCT01832961|143314855|OTHER||||||<|0.05|||||||Friedman's Test|Friedman's test followed by Dunn's multiple comparison||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).|||<0.05
71896378|NCT01832961|143314856|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
71896379|NCT01832961|143314857|OTHER||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)|||<0.05
71896380|NCT01832961|143314858|OTHER||||||<|0.05|||||||T-test|T-test was used to comparisons before and after FeNO results||||||<0.05
71896381|NCT01832961|143314859|OTHER||||||<|0.05|||||||T-test|||||||<0.05
71896382|NCT01274897|143314916|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|71.0|||||TWO_SIDED|95.0|71.0|81.0||The immune response considered sufficient if for serogroup A the lower limit of the two-sided 95% Clopper-Pearson confidence interval (CI) of the percentage of subjects with hSBA seroresponse is ≥50%.|Clopper and Pearson||For serogroup A.|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||81|71|
71896383|NCT01274897|143314916|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|82.0|||||TWO_SIDED|95.0|82.0|90.0||The immune response was considered sufficient if for serogroup C, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup C|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||90|82|
71896384|NCT01274897|143314916|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|23.0|||||TWO_SIDED|95.0|23.0|33.0||The immune response was considered sufficient if for serogroup W, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For the serogroup W|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||33|23|
71814130|NCT00860067|143130474|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV A/H1N1.|Ratio of geometric mean|1.09|||||TWO_SIDED|95.0|1.01|1.18|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.18|1.01|
71814131|NCT00860067|143130474|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV A/H3N2.|Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.14|0.96|
71814132|NCT00860067|143130474|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: (FluMist B/Yamagata) divided by (Q/LAIV B/Yamagata).|Ratio of geometric mean|1.1|||||TWO_SIDED|95.0|0.97|1.25|||Bootstrapping|Confidence intervals calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.25|0.97|
71814133|NCT00860067|143130474|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj \> 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: (FluMist B/Victoria) divided by (Q/LAIV B/Victoria).|Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.82|1.03|||Bootstrapping|Confidence intervals were calculated based on bootstrapping method.||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog\^e (mean \[log\^e x\]) where x was the assay result and e was the natural logarithm.||1.03|0.82|
71814134|NCT00560612|143130504|SUPERIORITY|||||||0.7054|||||||t-test, 2 sided|||||||0.7054
71814135|NCT00560612|143130505|SUPERIORITY|||||||0.4583|||||||t-test, 2 sided|||||||0.4583
71814136|NCT00560612|143130506|SUPERIORITY|||||||0.7443|||||||t-test, 2 sided|||||||0.7443
71814137|NCT00560612|143130507|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
71896385|NCT01274897|143314916|SUPERIORITY_OR_OTHER||Lower limit of the two-sided 95% CI|63.0|||||TWO_SIDED|95.0|63.0|74.0||The immune response was considered sufficient if for serogroup Y, the lower limit of the two-sided 95% CI of the percentage of subjects with hSBA seroresponse was ≥50%.|Clopper and Pearson||For serogroup Y|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is \< 50%.||74|63|
71896386|NCT01821677|143314920|SUPERIORITY|||||||0.16|||||||ANCOVA|||||||0.16
71814138|NCT01060553|143130508|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||for mcs||||.15
71896387|NCT01821677|143314920|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
71814139|NCT01060553|143130508|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||t-test, 2 sided|||for pcs||||.28
71814140|NCT01060553|143130509|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||for sleep duration||||.34
71814141|NCT01060553|143130509|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||for sleep disturbance||||.001
71814142|NCT01060553|143130509|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||for sleep latency||||.015
71814143|NCT02481375|143130516|OTHER||Marginal means|0.0|||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Marginal means (95% CI) of ferritin concentrations at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters||||<0.05
71814144|NCT04037436|143130526|OTHER|GEE|GEE|1.65||||0.05|TWO_SIDED|95.0|-4.44|7.73|||GEE|To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||To model the interaction between exposure to the MoveStrong program and site on secondary outcomes we applied a generalized estimating equation (GEE).||7.73|-4.44|0.05
71814145|NCT00201864|143130531|SUPERIORITY_OR_OTHER|||||||0.9102|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.9102
71814146|NCT00985985|143130586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.3851|TWO_SIDED|95.0|0.78|1.92|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center)|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||1.92|0.78|0.3851
71814147|NCT00985985|143130586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.0565|TWO_SIDED|95.0|0.99|3.32|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center).|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.||3.32|0.99|0.0565
71896388|NCT01821677|143314920|SUPERIORITY|||||||0.03|||||||ANCOVA|||||||0.03
71896389|NCT01821677|143314921|SUPERIORITY|||||||0.42|||||||ANCOVA|||||||0.42
71896390|NCT01821677|143314921|SUPERIORITY|||||||0.28|||||||ANCOVA|||||||0.28
71896391|NCT01821677|143314921|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71896392|NCT03551522|143314922|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|11.02||||0.0874|TWO_SIDED|95.0|-1.63|23.67|||ANCOVA|||||23.67|-1.63|0.0874
71896393|NCT03551522|143314922|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|6.54||||0.3151|TWO_SIDED|95.0|-6.28|19.37|||ANCOVA|||||19.37|-6.28|0.3151
71896394|NCT03551522|143314922|OTHER|The LS Means, confidence intervals, and p-values come from an ANCOVA model with relative (percent) change from baseline as the dependent variable and treatment and stratification groups (diabetic status and fibrosis stage) as factors and baseline as a covariate.|LS Mean of Difference|7.78||||0.2313|TWO_SIDED|95.0|-5.01|20.58|||ANCOVA|||||20.58|-5.01|0.2313
71896395|NCT01894516|143314931|SUPERIORITY||Difference in percentage rates|37.5|||<|0.0001|TWO_SIDED|95.0|22.4|52.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||52.6|22.4|< 0.0001
71896396|NCT01894516|143314931|SUPERIORITY||Difference in percentage rates|36.5|||<|0.0001|TWO_SIDED|95.0|21.3|51.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||51.8|21.3|< 0.0001
71896397|NCT01894516|143314931|SUPERIORITY||Difference in percentage rates|43.3|||<|0.0001|TWO_SIDED|95.0|28.4|58.2||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||58.2|28.4|< 0.0001
71896398|NCT03191396|143314947|NON_INFERIORITY|HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.|Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56||The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.|ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.||-0.56|-0.82|<0.0001
71896399|NCT03191396|143314947|SUPERIORITY||Treatment difference|-0.69|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.56|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-0.56|-0.82|<0.0001
71896400|NCT03191396|143314948|SUPERIORITY||Treatment difference|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.57|-3.09|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|||-3.09|-4.57|<0.0001
71896401|NCT00417612|143315028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
71896402|NCT01981122|143315037|SUPERIORITY|||||||0.095|||||||Mixed Models Analysis|Repeated Measures||||||.095
71896403|NCT01330381|143315038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9002|||||||Cochran-Mantel-Haenszel|||||||0.9002
71896404|NCT01330381|143315039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||Cochran-Mantel-Haenszel|||||||0.3520
71896405|NCT01330381|143315040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5228|||||||Cochran-Mantel-Haenszel|||||||0.5228
71896406|NCT01330381|143315049|SUPERIORITY_OR_OTHER_LEGACY|||||||0.377|||||||Chi-squared|||||||0.377
71896407|NCT01330381|143315052|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1599|||||||Van Elteren test|||||||0.1599
71896408|NCT01330381|143315053|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Van Elteren test|||||||0.0003
71896409|NCT01330381|143315054|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4647|||||||Van Elteren test|||||||0.4647
71896410|NCT01330381|143315055|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Van Elteren test|||||||<0.0001
71896411|NCT01330381|143315056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3044|||||||Van Elteren test|||||||0.3044
71896412|NCT02435173|143315073|SUPERIORITY||Adjusted means difference|-0.24|STANDARD_ERROR_OF_MEAN|0.06||0.0012|TWO_SIDED|95.0|-0.37|-0.11|||ANCOVA|Treatment as a fixed effect and log10 transformed baseline SPD as a covariate.||||-0.11|-0.37|0.0012
71896413|NCT02435173|143315074|SUPERIORITY||Adjusted means difference|40.13|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|28.51|51.75|||ANCOVA|Treatment as a fixed effect and baseline as a covariate.||||51.75|28.51|<0.0001
71896414|NCT03216265|143315090|OTHER||Least Square Mean difference|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.78|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2).|||-0.78|-2.10|<0.0001
71896415|NCT01539837|143315145|SUPERIORITY||||||<|0.01||||||calculated|Pairwise comparisons,post-hoc Bonferoni|||||||<0.01
71896416|NCT02988986|143315146|SUPERIORITY|Based on prior data for Ki67 changes in the tamoxifen arm alone, we will assume null hypothesis and alternative hypotheses of 60% and 80% reduction in Ki67, respectively. A sample of 25 patients will provide 86% power to detect the hypothesized reduction in Ki67 with 5% alpha based on a two-sided, one sample t-test of mean percent change in Ki67 level.|||||=|0.0023|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was the change in Ki67 after 6 weeks of treatment.||||=0.0023
71896417|NCT00685178|143315165|SUPERIORITY||F-value for main effect of Condition|2.21||||0.531|TWO_SIDED|||||Using the proportion of negative urine samples obtained, the four groups were compared to determine whether there are any group differences in cocaine abstinence (as measured by negative urine samples).|Chi-squared||F-value for main effect of Drug Condition|||||0.531
71896418|NCT00685178|143315166|SUPERIORITY||Spearmann's rank correlation|0.969|||<|0.001|TWO_SIDED||||||ANOVA||CR subjects only|Analyses were performed to measure the correlation between CR groups (topiramate + CR and Placebo + CR) and abstinence.||||<0.001
71896419|NCT00685178|143315166|SUPERIORITY||Spearmann's rank correlation|0.494|||<|0.001|TWO_SIDED||||||Generalized Estimating Equation (GEE)||NonCR subjects only|Analyses were performed to measure the correlation between Non-CR groups (topiramate + NonCR and Placebo + NonCR) and abstinence.||||<0.001
71896420|NCT00077623|143315167|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.141|||<|0.0001|TWO_SIDED|97.5|-0.098|0.38||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.380|-0.098|<0.0001
71896421|NCT00077623|143315167|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity .|Mean Difference between groups|-0.022|||<|0.0001|TWO_SIDED|97.5|-0.262|0.217||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)||0.217|-0.262|<0.0001
71896422|NCT00401973|143315212|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|Mixed Models Analysis|Repeated Measures Analysis||To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine \& adjunctive treatment' arm at Week 22.||||0.065
71896423|NCT00401973|143315212|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||Hypothesis=weight gain associated with olanzapine can be prevented or mitigated with an adjunctive pharmacological algorithm.||||0.113
71896424|NCT00401973|143315212|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Repeated Measures Analysis||||||0.036
71896425|NCT00401973|143315213|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.498
71896426|NCT00401973|143315213|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.637
71896427|NCT00401973|143315213|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.125
71896428|NCT00401973|143315214|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.173
71896429|NCT00401973|143315214|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.016
71896430|NCT00401973|143315214|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.029
71896431|NCT00401973|143315215|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.017
71896432|NCT00401973|143315215|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.015
71896433|NCT00401973|143315215|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.071
71896434|NCT00401973|143315216|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.152
71896435|NCT00401973|143315216|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.350
71896436|NCT00401973|143315216|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.123
71896437|NCT00401973|143315217|SUPERIORITY_OR_OTHER|||||||0.499||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.499
71896438|NCT00401973|143315217|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.833
71896439|NCT00401973|143315217|SUPERIORITY_OR_OTHER|||||||0.339||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.339
71896440|NCT00401973|143315218|SUPERIORITY_OR_OTHER|||||||0.278||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.278
71896441|NCT00401973|143315218|SUPERIORITY_OR_OTHER|||||||0.976||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.976
71896442|NCT00401973|143315218|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.049
71896443|NCT00401973|143315219|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.122
71896444|NCT00401973|143315219|SUPERIORITY_OR_OTHER|||||||0.225||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.225
71896445|NCT00401973|143315219|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.124
71896446|NCT00401973|143315220|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.020
71896447|NCT00401973|143315220|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.037
71896448|NCT00401973|143315220|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.038
71896449|NCT00401973|143315221|SUPERIORITY_OR_OTHER|||||||0.474||95.0||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA|||||||0.474
71896450|NCT00401973|143315221|SUPERIORITY_OR_OTHER|||||||0.404||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.404
71896451|NCT00401973|143315221|SUPERIORITY_OR_OTHER|||||||0.652||95.0||||P-value for Change from Baseline|ANCOVA|||||||0.652
71677398|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.424|||||TWO_SIDED|95.0|0.294|0.61||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.610|0.294|
71677399|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.684|||||TWO_SIDED|95.0|0.473|0.99||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.990|0.473|
71677400|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.025|||||TWO_SIDED|95.0|0.714|1.473||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.473|0.714|
71677401|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.656|||||TWO_SIDED|95.0|1.15|2.385||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.385|1.150|
71677402|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.615|||||TWO_SIDED|95.0|1.115|2.339||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.339|1.115|
71677403|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.906|||||TWO_SIDED|95.0|1.177|3.087||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.087|1.177|
71677404|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.945|||||TWO_SIDED|95.0|0.583|1.533||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.533|0.583|
71677405|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.763|||||TWO_SIDED|95.0|0.468|1.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.245|0.468|
71677406|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.818|||||TWO_SIDED|95.0|1.119|2.956||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.956|1.119|
71677407|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.917|||||TWO_SIDED|95.0|0.568|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.568|
71882173|NCT02831673|143283263|OTHER||Ratio of geometric means|0.839||||0.006|TWO_SIDED|95.0|0.742|0.95|||Mixed Model Repeated Measures||Week 96. Urine Albumin/Creatinine.|||0.950|0.742|0.006
71882174|NCT02831673|143283263|OTHER||Ratio of geometric means|0.551|||<|0.001|TWO_SIDED|95.0|0.445|0.682|||Mixed Model Repeated Measures||Week 96. Urine B2M/Urine Creatinine.|||0.682|0.445|<0.001
71896452|NCT01954628|143315254|SUPERIORITY_OR_OTHER||Least sqaure mean difference|23.7||||0.759|TWO_SIDED|95.0|-128.3|175.7||AAC were compared between treatments using an analysis of variance model adjusting for treatment and region as factors and including the baseline score as a covariate.|ANOVA|||Sample size based on area above the daily EXACT score curve (AAC) from Day 1 to Day 29 from subjects with an acute COPD exacerbation, collected over 28 days. Assuming a residual SD of 500 points, a sample size of 200 subjects per arm would be expected to have an 80% power to detect a true treatment difference in the AAC of 140 points over 12-weeks treatment, using a 2-sided test; alpha-level of 0.05.This difference corresponds to a mean daily improvement of 1.67 points on the EXACT symptom score||175.7|-128.3|0.759
71896453|NCT01954628|143315255|SUPERIORITY_OR_OTHER||Least sqaure mean difference|-0.34||||0.588|TWO_SIDED|95.0|-1.57|0.89|||ANOVA|||ANOVA model with fixed factors treatment, region and baseline total CAT score as covariate were used. Missing post-treatment data were imputed using the Last Observation Carried Forward principle.||0.89|-1.57|0.588
71896454|NCT01954628|143315256|SUPERIORITY_OR_OTHER||Least sqaure mean difference|1.083||||0.646|TWO_SIDED|95.0|0.771|1.52|||Negative binomial regression model|Negative binomial regression model with fixed factors treatment, region and time in study as offset.||The number of subjects with at least one COPD exacerbation were summarised by treatment group.||1.520|0.771|0.646
71896455|NCT01954628|143315259|SUPERIORITY_OR_OTHER|||||||0.226|||||||ANOVA|||Missing post-treatment data was imputed using the Last Observation Carried Forward principle.||||0.226
71896456|NCT01650779|143315268|SUPERIORITY_OR_OTHER|||||||0.0002|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.0002
71896457|NCT01650779|143315268|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||<0.0001
71896458|NCT01650779|143315268|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||<0.0001
71896459|NCT01650779|143315269|SUPERIORITY_OR_OTHER|||||||0.1178|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.||||0.1178
71896460|NCT01650779|143315269|SUPERIORITY_OR_OTHER|||||||0.1176|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.||||0.1176
71896461|NCT01650779|143315269|SUPERIORITY_OR_OTHER|||||||0.0322|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.||||0.0322
71896462|NCT01650779|143315270|SUPERIORITY_OR_OTHER|||||||0.5811|||||||One sample test of median (sign test)|||Baseline versus Month 2: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.5811
71896463|NCT01650779|143315270|SUPERIORITY_OR_OTHER|||||||0.7744|||||||One sample test of median (sign test)|||Baseline versus Month 4: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.7744
71896464|NCT01650779|143315270|SUPERIORITY_OR_OTHER|||||||0.3877|||||||One sample test of median (sign test)|||Baseline versus Month 6: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.||||0.3877
71896465|NCT03065530|143315296|OTHER||||||<|0.05|||||||Kruskal-Wallis|||The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.||||<0.05
71896466|NCT01512368|143315320|SUPERIORITY_OR_OTHER||Slope|0.089|STANDARD_ERROR_OF_MEAN|0.063|<|0.001|TWO_SIDED|95.0|0.034|0.144||All reported p values are based on two-sided tests considering ≤0.05 as significant.|Regression, Linear|Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.|Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.|"FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final - basal levels (delta)."||0.144|0.034|<0.001
71896467|NCT02042131|143315452|SUPERIORITY|||||||0.082|||||||Log Rank|||Omnibus test of all three groups||||.082
71896468|NCT02042131|143315452|SUPERIORITY|||||||0.028|||||||Log Rank|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||.028
71896469|NCT02042131|143315452|SUPERIORITY||Cox Proportional Hazard|0.24||||0.04|TWO_SIDED|95.0|0.06|0.96|||Regression, Cox|||Planned contrast #1: TAU vs. S-CRP/E-CRP||0.96|0.06|.040
71896470|NCT02042131|143315453|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Omnibus test comparing all three groups.||||<0.001
71896471|NCT02042131|143315453|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
71896472|NCT02042131|143315454|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP||||<0.001
71896473|NCT02042131|143315455|SUPERIORITY|||||||0.04|||||||Chi-squared|||Omnibus test of all groups||||0.040
71896474|NCT02042131|143315455|SUPERIORITY||Odds Ratio (OR)|0.1||||0.045|TWO_SIDED|95.0|0.002|0.9|||Chi-squared|||Planned contrast #2: E-CRP vs. TAU/S-CRP||0.9|0.002|0.045
71896475|NCT00377299|143315485|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||0.05
71896476|NCT00377299|143315486|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
71896477|NCT00377299|143315487|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
71896478|NCT00377299|143315488|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
71896479|NCT00377299|143315489|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance was set at a p value of ≤ 0.05.|ANCOVA|||||||>0.05
71896480|NCT00035815|143315491|SUPERIORITY_OR_OTHER|||||||0.529||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis of MMT was calculated as a ratio of change from baseline to last follow-up to time to duration until last follow-up. For the patients that died during the study period, the last follow-up time was considered as the time of death with a zero score for MMT measurement. Analysis was performed using intention to treat approach. Comparison of rate of change in MMT scores between the placebo and IGF-1 group was made using two sample t-test or Wilcoxon rank sum test as appropriate.||||0.529
71896481|NCT00035815|143315492|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.415|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Patients who elected to proceed to tracheostomy were assessed on the day of their procedure. Subjects who continuously utilized NIPPV for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous NIPPV. Survival between groups was compared using the Cox-proportional Hazards model.||1.4|0.77|0.415
71896482|NCT00035815|143315493|SUPERIORITY_OR_OTHER|||||||0.321||95.0|||||Wilcoxon (Mann-Whitney)|||The final secondary outcome measure was the rate of change in the ALSFRS-r score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.||||0.321
71896483|NCT00283712|143315512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|90.0|-0.22|0.22|||Fisher Exact|||The study goals were to gather evidence of safety and possible efficacy of infliximab for treatment of pemphigus vulgaris (PV). The analyses focused on estimation rather than hypothesis testing; therefore, there was not sufficient power to detect plausible treatment differences unless they were very large. The sample size reflects a balance between the desire to meet study goals and to expose as few participants as possible until the safety of infliximab for treatment of PV has been clarified.||0.22|-0.22|1.00
71896484|NCT00283712|143315512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|90.0|0.02|42.67|||Fisher Exact|||||42.67|0.02|1.00
71896485|NCT00283712|143315513|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|90.0|-0.26|0.06||||||||0.06|-0.26|
71896486|NCT00283712|143315514|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||1|TWO_SIDED|90.0|-0.31|0.36||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||0.36|-0.31|1.00
71896487|NCT00283712|143315514|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||1|TWO_SIDED|90.0|0.02|38.35||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.||38.35|0.02|1.00
71677408|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.855|||||TWO_SIDED|95.0|0.524|1.396||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.396|0.524|
71896488|NCT00283712|143315515|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2||||0.65|TWO_SIDED|90.0|-0.15|0.55|||Fisher Exact|||||0.55|-0.15|0.65
71896489|NCT00283712|143315515|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.65|TWO_SIDED|90.0|0.06|2.79|||Fisher Exact|||||2.79|0.06|0.650
71896490|NCT00283712|143315525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|90.0|-0.3|0.3|||Fisher Exact|||||0.3|-0.3|1.00
71896491|NCT04329923|143315527|SUPERIORITY||Cox Proportional Hazard|0.58||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
71896492|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|16.0|||||TWO_SIDED|95.0|5.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||29|5|
71896493|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|32.0|||||TWO_SIDED|95.0|21.0|44.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||44|21|
71896494|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|15.0|||||TWO_SIDED|95.0|0.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.||30|0|
71896495|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|18.0|||||TWO_SIDED|95.0|5.0|31.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.||31|5|
71896496|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|18.0|||||TWO_SIDED|95.0|7.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||30|7|
71896497|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|30.0|||||TWO_SIDED|95.0|18.0|42.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||42|18|
71896498|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|19.0|||||TWO_SIDED|95.0|4.0|33.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||33|4|
71896499|NCT01272180|143315532|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.|Group Difference % (ABCWY+qOMV - ACWY)|15.0|||||TWO_SIDED|95.0|3.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.||29|3|
71896500|NCT01183858|143315543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.671|TWO_SIDED|95.0|0.83|1.33||Unstratified analysis.|Log Rank|||||1.33|0.83|0.671
71896501|NCT01183858|143315549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.625|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||||1.33|0.84|0.625
71896502|NCT02747043|143315552|EQUIVALENCE|Clinical equivalence of the primary endpoint will first be demonstrated by comparing the 1-sided 95% lower confidence limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority margin of -15%. If this is successful, the 1-sided upper 95% confidence limit of the RD of ORR by week 28 will be compared with a nonsuperiority margin of +35.5%.|Risk Difference (RD)|7.7|||||TWO_SIDED|90.0|-1.4|16.8|||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR by week 28 used a generalized linear model adjusted for the stratification factors (geographic region and age group).|||16.8|-1.4|
71896503|NCT02747043|143315552|OTHER||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|-3.2|18.6||||||||18.6|-3.2|
71896504|NCT02747043|143315553|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|90.0|-9.3|11.2||||||The 2-sided 90% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||11.2|-9.3|
71896505|NCT02747043|143315553|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-11.3|13.2||||||The 2-sided 95% confidence limits of the risk difference (RD) of ORR at week 12 used a generalized linear model adjusted for the stratification factors (geographic region and age group).||13.2|-11.3|
71896506|NCT02747043|143315559|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-8.3|16.3||||||Percentage risk difference for 'Any adverse event of interest'||16.3|-8.3|
71896507|NCT02747043|143315559|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-12.1|12.3||||||Percentage risk difference for 'Infusion reactions including hypersensitivity'||12.3|-12.1|
71896508|NCT02747043|143315559|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.7|||||TWO_SIDED|95.0|-11.8|13.0||||||Percentage risk difference for 'Hematological reactions'||13.0|-11.8|
71896509|NCT02747043|143315559|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.8|13.2||||||Percentage risk difference in 'Cardiac disorders'||13.2|-11.8|
71896510|NCT02747043|143315559|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-10.9|14.0||||||Percentage risk difference in 'Serious infections'||14.0|-10.9|
71896511|NCT02747043|143315559|OTHER|Risk difference (ABP 798 - Rituximab) and CIs were estimated by Wald asymptotic confidence limits, or exact confidence limits if n \< 25 for either treatment.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-11.7|13.2||||||Percentage risk difference in 'Severe mucocutaneous reactions'||13.2|-11.7|
71896512|NCT00641147|143315603|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||||||0.58
71896513|NCT00641147|143315603|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||0.57
71896514|NCT00641147|143315604|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71896515|NCT00641147|143315605|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||0.85
71896516|NCT00641147|143315606|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71896517|NCT00641147|143315607|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71896518|NCT00641147|143315608|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71896519|NCT00641147|143315609|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71896520|NCT00641147|143315610|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71896521|NCT00641147|143315611|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71896522|NCT00641147|143315612|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71896523|NCT00641147|143315613|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71896524|NCT00641147|143315614|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71896525|NCT00641147|143315618|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71896526|NCT01629667|143315624|SUPERIORITY_OR_OTHER||Least square mean difference|-1.77||||0.14|TWO_SIDED|95.0|-4.13|0.59|||ANCOVA|||||0.59|-4.13|0.140
71896527|NCT01629667|143315624|SUPERIORITY_OR_OTHER||Least square mean difference|-1.41||||0.234|TWO_SIDED|95.0|-3.73|0.91|||ANCOVA|||||0.91|-3.73|0.234
71896528|NCT01380093|143315654|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-31.7|-18.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.1|-31.7|<0.0001
71896529|NCT01380093|143315654|SUPERIORITY_OR_OTHER||LS Mean Difference|11.9||||0.0009|TWO_SIDED|95.0|5.1|18.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.6|5.1|0.0009
71896530|NCT01380093|143315654|SUPERIORITY_OR_OTHER||LS Mean Difference|36.8|||<|0.0001|TWO_SIDED|95.0|30.0|43.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||43.6|30.0|<0.0001
71688667|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|7.73|STANDARD_ERROR_OF_MEAN|2.78||0.0099|TWO_SIDED|90.0|2.98|12.47|||t-test, 2 sided|||Lung, Right Upper Lobe Ventilation||12.47|2.98|0.0099
71882175|NCT02831673|143283263|OTHER||Ratio of geometric means|1.045||||0.467|TWO_SIDED|95.0|0.928|1.175|||Mixed Model Repeated Measures||Week 96. Urine Phosphate.|||1.175|0.928|0.467
71882176|NCT02831673|143283263|OTHER||Ratio of geometric means|0.824|||<|0.001|TWO_SIDED|95.0|0.764|0.889|||Mixed Model Repeated Measures||Week 96. Urine Protein/Creatinine.|||0.889|0.764|<0.001
71882177|NCT02831673|143283263|OTHER||Ratio of geometric means|0.74|||<|0.001|TWO_SIDED|95.0|0.651|0.84|||Mixed Model Repeated Measures||Week 96. Urine RBP 4/Urine Creatinine|||0.840|0.651|<0.001
71882178|NCT02831673|143283264|OTHER||Ratio of geometric means|0.916||||0.205|TWO_SIDED|95.0|0.799|1.05|||Mixed Model Repeated Measures||Week 144. Urine Albumin/Creatinine.|||1.050|0.799|0.205
71882179|NCT02831673|143283264|OTHER||Ratio of geometric means|0.495|||<|0.001|TWO_SIDED|95.0|0.406|0.603|||Mixed Model Repeated Measures||Week 144. Urine B2M/Urine Creatinine.|||0.603|0.406|<0.001
71882180|NCT02831673|143283264|OTHER||Ratio of geometric means|1.089||||0.16|TWO_SIDED|95.0|0.967|1.226|||Mixed Model Repeated Measures||Week 144. Urine Phosphate.|||1.226|0.967|0.160
71882181|NCT02831673|143283264|OTHER||Ratio of geometric means|0.817|||<|0.001|TWO_SIDED|95.0|0.753|0.885|||Mixed Model Repeated Measures||Week 144. Urine Protein/Creatinine.|||0.885|0.753|<0.001
71882182|NCT02831673|143283264|OTHER||Ratio of geometric means|0.679|||<|0.001|TWO_SIDED|95.0|0.607|0.76|||Mixed Model Repeated Measures||Week 144. Urine RBP 4/Urine Creatinine|||0.760|0.607|<0.001
71882183|NCT02831673|143283265|OTHER||Mean Difference (Net)|-2.23|||<|0.001|TWO_SIDED|95.0|-2.75|-1.7|||Mixed Model Repeated Measures||Week 24. Bone ALP|||-1.70|-2.75|<0.001
71882184|NCT02831673|143283265|OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.19|-1.98|||Mixed Model Repeated Measures||Week 48. Bone ALP|||-1.98|-3.19|<0.001
71882185|NCT02831673|143283265|OTHER||Mean Difference (Net)|-4.19|||<|0.001|TWO_SIDED|95.0|-5.15|-3.23|||Mixed Model Repeated Measures||Week 28. Serum Osteocalcin|||-3.23|-5.15|<0.001
71882186|NCT02831673|143283265|OTHER||Mean Difference (Net)|-5.23|||<|0.001|TWO_SIDED|95.0|-6.22|-4.23|||Mixed Model Repeated Measures||Week 48. Serum Osteocalcin|||-4.23|-6.22|<0.001
71882187|NCT02831673|143283265|OTHER||Mean Difference (Net)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.5|-11.1|||Mixed Model Repeated Measures||Week 24. Serum PINP|||-11.1|-16.5|<0.001
71882188|NCT02831673|143283265|OTHER||Mean Difference (Net)|-12.6|||<|0.001|TWO_SIDED|95.0|-15.0|-10.3|||Mixed Model Repeated Measures||Week 48. Serum PINP|||-10.3|-15.0|<0.001
71882189|NCT02831673|143283265|OTHER||Mean Difference (Net)|-0.1628|||<|0.001|TWO_SIDED|95.0|-0.2015|-0.1241|||Mixed Model Repeated Measures||Week 24. CTX-1|||-0.1241|-0.2015|<0.001
71882190|NCT02831673|143283265|OTHER||Mean Difference (Net)|-0.2015|||<|0.001|TWO_SIDED|95.0|-0.246|-0.1569|||Mixed Model Repeated Measures||Week 48. CTX-1|||-0.1569|-0.2460|<0.001
71882191|NCT02831673|143283266|OTHER||Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.63|-1.5|||Mixed Model Repeated Measures||Week 96, Bone ALP|||-1.50|-2.63|<0.001
71882192|NCT02831673|143283266|OTHER||Mean Difference (Net)|-4.17|||<|0.001|TWO_SIDED|95.0|-5.2|-3.14|||Mixed Model Repeated Measures||Week 96, Serum Osteocalcin|||-3.14|-5.20|<0.001
71882193|NCT02831673|143283266|OTHER||Mean Difference (Net)|-13.3|||<|0.001|TWO_SIDED|95.0|-17.6|-8.9|||Mixed Model Repeated Measures||Week 96, Serum PINP|||-8.9|-17.6|<0.001
71882194|NCT02831673|143283266|OTHER||Mean Difference (Net)|-0.1592|||<|0.001|TWO_SIDED|95.0|-0.208|-0.1104|||Mixed Model Repeated Measures||Week 96, CTX-1|||-0.1104|-0.2080|<0.001
71882195|NCT02831673|143283267|OTHER||Mean Difference (Net)|-1.68|||<|0.001|TWO_SIDED|95.0|-2.23|-1.14|||Mixed Model Repeated Measures||Week 144, Bone ALP|||-1.14|-2.23|<0.001
71882196|NCT02831673|143283267|OTHER||Mean Difference (Net)|-2.91|||<|0.001|TWO_SIDED|95.0|-4.0|-1.83|||Mixed Model Repeated Measures||Week 144, Serum Osteocalcin|||-1.83|-4.00|<0.001
71882197|NCT02831673|143283267|OTHER||Mean Difference (Net)|-9.2|||<|0.001|TWO_SIDED|95.0|-12.3|-6.2|||Mixed Model Repeated Measures||Week 144, Serum PINP|||-6.2|-12.3|<0.001
71882198|NCT02831673|143283267|OTHER||Mean Difference (Net)|-0.1414|||<|0.001|TWO_SIDED|95.0|-0.1771|-0.1056|||Mixed Model Repeated Measures||Week 144, CTX-1|||-0.1056|-0.1771|<0.001
71882199|NCT02831673|143283268|OTHER||Mean Difference (Net)|-6.5|||<|0.001|TWO_SIDED|95.0|-9.9|-3.0|||Mixed Model Repeated Measures||Week 24|||-3.0|-9.9|<0.001
71882200|NCT02831673|143283268|OTHER||Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-9.0|-3.4|||Mixed Model Repeated Measures||Week 48|||-3.4|-9.0|<0.001
71882201|NCT02831673|143283269|OTHER||Mean Difference (Net)|-2.9||||0.048|TWO_SIDED|95.0|-5.8|0.0|||Mixed Model Repeated Measures||Week 96|||0.0|-5.8|0.048
71882202|NCT02831673|143283270|OTHER||Mean Difference (Net)|-4.9||||0.004|TWO_SIDED|95.0|-8.3|-1.6|||Mixed Model Repeated Measures||Week 144|||-1.6|-8.3|0.004
71882203|NCT02831673|143283277|OTHER||Difference in percentage|2.0||||0.157|TWO_SIDED|95.0|-0.6|4.6||Fisher's exact p-value.|Fisher Exact||Week 24|||4.6|-0.6|0.157
71882204|NCT02831673|143283277|OTHER||Difference in percentage|1.3||||0.414|TWO_SIDED|95.0|-1.7|4.2||Fisher's exact p-value.|Fisher Exact||Week 48|||4.2|-1.7|0.414
71814149|NCT00509236|143130596|SUPERIORITY_OR_OTHER||Difference in % Affected|-4.8||||0.336|TWO_SIDED|95.0|-15.7|5.6||Miettinen \& Nurminen method stratified by prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent).|Miettinen & Nurminen|||||5.6|-15.7|0.336
71814150|NCT00509236|143130597|SUPERIORITY_OR_OTHER||Difference in % Affected|2.8|||||TWO_SIDED|95.0|-10.9|16.5||||||||16.5|-10.9|
71814151|NCT00509236|143130598|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-26.6|||<|0.001|TWO_SIDED|95.0|-38.0|-15.3|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-15.3|-38.0|<0.001
71814152|NCT00509236|143130598|SUPERIORITY_OR_OTHER||Change from Baseline in LS Mean|-31.2|||<|0.001|TWO_SIDED|95.0|-42.6|-19.9|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||-19.9|-42.6|<0.001
71814153|NCT00509236|143130598|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|||||TWO_SIDED|95.0|-11.5|20.7||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.||20.7|-11.5|
71814154|NCT00509236|143130599|SUPERIORITY_OR_OTHER||Difference in LS Means|0.15|||||TWO_SIDED|95.0|-0.18|0.49|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.||0.49|-0.18|
71814155|NCT03587142|143130621|SUPERIORITY||Mean Difference (Net)|-0.11||||0.69|TWO_SIDED|95.0|-0.68|0.45||Nominal P value. Power was determined at a level of P=0.05.|ANCOVA|Multiple imputation using regression and 50 datasets to estimate the outcome for the 18/96 (19%) randomized patients without the f4 visit data.||Primary outcome analysis uses a difference of differences analysis between Buspirone compared to the Placebo arm in which the adjusted mean difference of differences, Wald 95% Confidence interval and 2-sided P values are determined from a Wald Chi-Square test. Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Negative change indicates symptom improvement.||0.45|-0.68|0.69
71814156|NCT03587142|143130621|SUPERIORITY||Mean Difference (Net)|-0.13||||0.62|TWO_SIDED|95.0|-0.65|0.39||P value is nominal; no adjustments made from multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005.|ANCOVA|||Sensitivity analysis of change from a baseline in ES/PPF (Early Satiety/Postprandial Fullness subscore) using all completers: 39 participants in Buspirone arm, 39 participants in placebo arm.||0.39|-0.65|0.62
71814157|NCT03587142|143130621|SUPERIORITY||Mean Difference (Net)|-0.25||||0.62|TWO_SIDED|95.0|-0.89|0.38||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Sensitivity analyses: change in ES/PPF in treatment adherent patients: 23 participants in Buspirone arm, 29 patients in placebo arm.||0.38|-0.89|0.62
71814158|NCT03587142|143130622|SUPERIORITY||Mean Difference (Net)|-0.09||||0.76|TWO_SIDED|95.0|-0.69|0.5||Nominal P value reported. Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||The mean difference of differences (DoD) between Buspirone and Placebo, 95% confidence interval and P (2-sided) were derived from an ANCOVA, regressing an indicator for treatment group on fullness severity score, adjusting for the baseline value of fullness severity score.||0.50|-0.69|0.76
71814159|NCT03587142|143130623|SUPERIORITY||Mean Difference (Net)|-0.15||||0.64|TWO_SIDED|95.0|-0.76|0.47||Nominal P values; Bonferroni p value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.47|-0.76|0.64
71814160|NCT03587142|143130624|SUPERIORITY||Mean Difference (Net)|-0.14||||0.66|TWO_SIDED|95.0|-0.79|0.5||P values are nominal; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.50|-0.79|0.66
71882205|NCT02831673|143283278|OTHER||Difference in percentage|1.0||||0.562|TWO_SIDED|95.0|-2.1|4.1||Fisher's exact p-value.|Fisher Exact||Week 96|||4.1|-2.1|0.562
71814161|NCT03587142|143130625|SUPERIORITY||Mean Difference (Net)|-0.12||||0.7|TWO_SIDED|95.0|-0.75|0.5||Nominal P values; Bonferroni p-value for the 10 sensitivity outcomes is \<0.005|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (s-sided) determined from a Wald Chi-Square test.||0.50|-0.75|0.70
71814162|NCT03587142|143130626|SUPERIORITY||Mean Difference (Net)|-0.2||||0.4|TWO_SIDED|95.0|-0.66|0.27||P value is nominal; no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. P (2-sided) were determined from a Wald Chi-Square test.||0.27|-0.66|0.40
71882206|NCT02831673|143283279|OTHER||Difference in percentage|0.9||||0.587|TWO_SIDED|95.0|-2.4|4.3||Fisher's exact p-value.|Fisher Exact||Week 144|||4.3|-2.4|0.587
71882207|NCT02831673|143283284|OTHER||Mean Difference (Net)|19.8|||||TWO_SIDED|95.0|-10.23|49.83|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||49.83|-10.23|
71896531|NCT01380093|143315655|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.7|||<|0.0001|TWO_SIDED|95.0|-20.2|-11.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.||-11.1|-20.2|<0.0001
71814163|NCT03587142|143130626|SUPERIORITY||Odds Ratio (OR)|1.31||||0.56|TWO_SIDED|95.0|0.53|3.21||Nominal P value without adjustment for multiple comparisons. Bonferroni threshold for level of significance is \<0.002.|Regression, Logistic|Odds ratio, 95% C.I. and P (two-sided) from a logistic regression of the binary outcome on treatment group for symptomatic improvement in GCSI.||GCSI symptomatic improvement of 1+ points in total GCSI symptom score defined as change in GCSI total score at week 4 from baseline being a decrease of 1 or more points. This is a binary variable where 1=1+ reduction in change in GCSI total score, 0=change in GCSI total score from baseline at 4-weeks is \< 1.0.||3.21|0.53|0.56
71814164|NCT03587142|143130627|SUPERIORITY||Mean Difference (Net)|-0.05||||0.86|TWO_SIDED|95.0|-0.58|0.48||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Squares test.||0.48|-0.58|0.86
71814165|NCT03587142|143130628|SUPERIORITY||Mean Difference (Net)|-0.06||||0.85|TWO_SIDED|95.0|-0.64|0.53||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald-Chi Square test.||0.53|-0.64|0.85
71814166|NCT03587142|143130629|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.76|0.47||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test||0.47|-0.76|0.65
71814167|NCT03587142|143130630|SUPERIORITY||Mean Difference (Net)|-0.41||||0.16|TWO_SIDED|95.0|-0.99|0.16||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.16|-0.99|0.16
71814168|NCT03587142|143130631|SUPERIORITY||Mean Difference (Net)|-0.65||||0.03|TWO_SIDED|95.0|-1.23|-0.08||P values are nominal; no adjustments made for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||-0.08|-1.23|0.03
71814169|NCT03587142|143130632|SUPERIORITY||Mean Difference (Net)|0.17||||0.59|TWO_SIDED|95.0|-0.44|0.77||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.77|-0.44|0.59
71814170|NCT03587142|143130633|SUPERIORITY||Mean Difference (Net)|0.24||||0.46|TWO_SIDED|95.0|-0.39|0.88||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.88|-0.39|0.46
71814171|NCT03587142|143130634|SUPERIORITY||Mean Difference (Net)|0.09||||0.73|TWO_SIDED|95.0|-0.42|0.59||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.59|-0.42|0.73
71814172|NCT03587142|143130635|SUPERIORITY||Mean Difference (Net)|-0.14||||0.5|TWO_SIDED|95.0|-0.55|0.27||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.27|-0.55|0.50
71814173|NCT03587142|143130636|SUPERIORITY||Mean Difference (Net)|0.32||||0.18|TWO_SIDED|95.0|-0.15|0.79||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.79|-0.15|0.18
71882208|NCT02831673|143283284|OTHER||Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|-57.07|58.4|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||58.40|-57.07|
71882209|NCT02831673|143283284|OTHER||Mean Difference (Net)|36.84|||||TWO_SIDED|95.0|-55.94|129.63|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||129.63|-55.94|
71882210|NCT02831673|143283284|OTHER||Mean Difference (Net)|14.37|||||TWO_SIDED|95.0|-13.38|42.12|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||42.12|-13.38|
71896532|NCT01380093|143315655|SUPERIORITY_OR_OTHER||LS Mean Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.9|18.0||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.0|8.9|<0.0001
71896533|NCT01380093|143315655|SUPERIORITY_OR_OTHER||LS Mean Difference|29.1|||<|0.0001|TWO_SIDED|95.0|24.6|33.7||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.7|24.6|<0.0001
71896534|NCT01380093|143315656|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.1|||<|0.0001|TWO_SIDED|95.0|-61.2|-41.0||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-41.0|-61.2|<0.0001
71896535|NCT01380093|143315656|SUPERIORITY_OR_OTHER||LS Mean Difference|24.6|||<|0.0001|TWO_SIDED|95.0|14.5|34.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.6|14.5|<0.0001
71896536|NCT01380093|143315656|SUPERIORITY_OR_OTHER||LS Mean Difference|75.7|||<|0.0001|TWO_SIDED|95.0|65.6|85.8||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||85.8|65.6|<0.0001
71896537|NCT01380093|143315657|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.9|||<|0.0001|TWO_SIDED|95.0|-11.8|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-11.8|<0.0001
71896538|NCT01380093|143315657|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2||||0.0006|TWO_SIDED|95.0|2.3|8.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.1|2.3|0.0006
71896539|NCT01380093|143315657|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1|||<|0.0001|TWO_SIDED|95.0|11.2|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.0|11.2|<0.0001
71896540|NCT01380093|143315658|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.8|||<|0.0001|TWO_SIDED|95.0|-62.0|-35.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.5|-62.0|<0.0001
71896541|NCT01380093|143315658|SUPERIORITY_OR_OTHER||LS Mean Difference|29.0|||<|0.0001|TWO_SIDED|95.0|15.8|42.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.3|15.8|<0.0001
71896542|NCT01380093|143315658|SUPERIORITY_OR_OTHER||LS Mean Difference|77.8|||<|0.0001|TWO_SIDED|95.0|64.5|91.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||91.0|64.5|<0.0001
71896543|NCT01380093|143315659|SUPERIORITY_OR_OTHER||LS Mean Difference|-68.6|||<|0.0001|TWO_SIDED|95.0|-95.0|-42.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-42.2|-95.0|<0.0001
71896544|NCT01380093|143315659|SUPERIORITY_OR_OTHER||LS Mean Difference|56.5|||<|0.0001|TWO_SIDED|95.0|30.1|82.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||82.8|30.1|<0.0001
71896545|NCT01380093|143315659|SUPERIORITY_OR_OTHER||LS Mean Difference|125.1|||<|0.0001|TWO_SIDED|95.0|98.7|151.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||151.5|98.7|<0.0001
71896546|NCT01380093|143315660|SUPERIORITY_OR_OTHER||LS Mean Difference|-76.0||||0.0001|TWO_SIDED|95.0|-112.8|-39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-39.2|-112.8|0.0001
71896547|NCT01380093|143315660|SUPERIORITY_OR_OTHER||LS Mean Difference|66.5||||0.0006|TWO_SIDED|95.0|29.8|103.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||103.2|29.8|0.0006
71896548|NCT01380093|143315660|SUPERIORITY_OR_OTHER||LS Mean Difference|142.5|||<|0.0001|TWO_SIDED|95.0|105.7|179.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||179.3|105.7|<0.0001
71896549|NCT01380093|143315661|SUPERIORITY_OR_OTHER||LS Mean Difference|-86.2||||0.0011|TWO_SIDED|95.0|-136.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-136.5|0.0011
71896550|NCT01380093|143315661|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8||||0.0071|TWO_SIDED|95.0|19.7|120.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||120.0|19.7|0.0071
71896551|NCT01380093|143315661|SUPERIORITY_OR_OTHER||LS Mean Difference|156.0|||<|0.0001|TWO_SIDED|95.0|105.7|206.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||206.3|105.7|<0.0001
71896552|NCT01380093|143315662|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.1254|TWO_SIDED|95.0|-0.6|4.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.7|-0.6|0.1254
71896553|NCT01380093|143315662|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.4592|TWO_SIDED|95.0|-3.6|1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.6|-3.6|0.4592
71896554|NCT01380093|143315662|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.0||||0.0251|TWO_SIDED|95.0|-5.6|-0.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.4|-5.6|0.0251
71896555|NCT01380093|143315663|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.4|||<|0.0001|TWO_SIDED|95.0|-19.9|-11.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.0|-19.9|<0.0001
71896556|NCT01380093|143315663|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|4.8|13.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.7|4.8|<0.0001
71896557|NCT01380093|143315663|SUPERIORITY_OR_OTHER||LS Mean Difference|24.7|||<|0.0001|TWO_SIDED|95.0|20.3|29.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||29.1|20.3|<0.0001
71896558|NCT01380093|143315664|SUPERIORITY_OR_OTHER||LS Mean Difference|-116.1|||<|0.0001|TWO_SIDED|95.0|-136.5|-95.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-95.7|-136.5|<0.0001
71896559|NCT01380093|143315664|SUPERIORITY_OR_OTHER||LS Mean Difference|59.7|||<|0.0001|TWO_SIDED|95.0|39.3|80.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.1|39.3|<0.0001
71896560|NCT01380093|143315664|SUPERIORITY_OR_OTHER||LS Mean Difference|175.8|||<|0.0001|TWO_SIDED|95.0|155.4|196.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||196.2|155.4|<0.0001
71896561|NCT01380093|143315665|SUPERIORITY_OR_OTHER||LS Mean Difference|-202.2|||<|0.0001|TWO_SIDED|95.0|-239.0|-165.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-165.3|-239.0|<0.0001
71896562|NCT01380093|143315665|SUPERIORITY_OR_OTHER||LS Mean Difference|122.5|||<|0.0001|TWO_SIDED|95.0|85.7|159.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||159.2|85.7|<0.0001
71896563|NCT01380093|143315665|SUPERIORITY_OR_OTHER||LS Mean Difference|324.6|||<|0.0001|TWO_SIDED|95.0|287.7|361.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||361.5|287.7|<0.0001
71896564|NCT01380093|143315666|SUPERIORITY_OR_OTHER||LS Mean Difference|-253.0|||<|0.0001|TWO_SIDED|95.0|-301.5|-204.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-204.5|-301.5|<0.0001
71882211|NCT02831673|143283284|OTHER||Mean Difference (Net)|25.14|||||TWO_SIDED|95.0|-9.56|59.85|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||59.85|-9.56|
71882212|NCT02831673|143283284|OTHER||Mean Difference (Net)|-7.82|||||TWO_SIDED|95.0|-55.98|40.34|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||40.34|-55.98|
71896565|NCT01380093|143315666|SUPERIORITY_OR_OTHER||LS Mean Difference|151.9|||<|0.0001|TWO_SIDED|95.0|103.5|200.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||200.2|103.5|<0.0001
71896566|NCT01380093|143315666|SUPERIORITY_OR_OTHER||LS Mean Difference|404.9|||<|0.0001|TWO_SIDED|95.0|356.4|453.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||453.3|356.4|<0.0001
71882213|NCT02831673|143283284|OTHER||Mean Difference (Net)|29.45|||||TWO_SIDED|95.0|-55.47|114.38|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||114.38|-55.47|
71882214|NCT02831673|143283284|OTHER||Mean Difference (Net)|17.67|||||TWO_SIDED|95.0|-49.89|85.23|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||85.23|-49.89|
71882215|NCT02831673|143283284|OTHER||Mean Difference (Net)|15.16|||||TWO_SIDED|95.0|-13.9|44.21|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||44.21|-13.90|
71882216|NCT02831673|143283284|OTHER||Mean Difference (Net)|22.51|||||TWO_SIDED|95.0|-9.52|54.54|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||54.54|-9.52|
71896567|NCT01380093|143315667|SUPERIORITY_OR_OTHER||LS Mean Difference|-306.8|||<|0.0001|TWO_SIDED|95.0|-370.9|-242.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-242.6|-370.9|<0.0001
71845591|NCT04941482|143205829|SUPERIORITY|Over 6 months, the number of patients who losted to follow-up of intervention and control group were respectively 9:0 (after 1 month), 9:0 (after 3 months), and 9:3 (after 6 months).|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.4|<|0.05|TWO_SIDED|95.0|-14.5|14.7|||t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Barthel Index score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|14.7|-14.5|<0.05
71845592|NCT04941482|143205830|SUPERIORITY||Mean Difference (Net)|-7.6|STANDARD_ERROR_OF_MEAN|5.6|<|0.05|TWO_SIDED|95.0|-18.8|3.7||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Physical domain score of Stroke Impact Scale before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|3.7|-18.8|<0.05
71845593|NCT04941482|143205831|SUPERIORITY||Mean Difference (Net)|-7.8|STANDARD_ERROR_OF_MEAN|-3.7|<|0.05|TWO_SIDED|95.0|-15.2|-0.3||The threshold for statistical significance was p = 0.05.|t-test, 2 sided||Treatment Difference = Intervention group - Control group|We calculated that 92 participants randomized in a 1:1 fashion between the 2 groups would have at least 80% power to detect a difference of 3.43 points in mean score in improving physical and mental health after stroke (based on J.Sims et al in 2008) between intervention and control groups from baseline to the 6th month. The sample size was determined using a 2-sided 2-sample t-test (a=0.05). Assumptions included a common standard deviation of 5.49 and a discontinuation rate of 10%.|(1) Variables with multiple measurements over time were compared using the repeated measures ANOVA test to assess changes in Stroke Impact Scale score before and after intervention in two groups, calculating the time\*group interaction; (2) Effect sizes after intervention are measured using Cohen's D, with values indicating small (d = 0.2), medium (d = 0.5), and large (d ≥ 0.8) effects.|-0.3|-15.2|<0.05
71845594|NCT02962102|143205863|SUPERIORITY|||||||0.52|||||||Fisher Exact|||||||0.52
71845595|NCT02962102|143205863|SUPERIORITY|||||||0.58|||||||Fisher Exact|||||||0.58
71845596|NCT02962102|143205864|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71845597|NCT02962102|143205864|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71845598|NCT02962102|143205865|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71845599|NCT02962102|143205865|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71845600|NCT05785832|143205893|SUPERIORITY||Mean Difference (Net)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-0.8|<0.001
71845601|NCT05785832|143205894|SUPERIORITY||Mean Difference (Net)|14.0|||<|0.001|TWO_SIDED|95.0|11.0|17.0|||Regression, Linear|||Adjusted Difference Between Groups||17|11|<0.001
71845602|NCT05785832|143205895|SUPERIORITY||Mean Difference (Net)|-21.0|||<|0.001|TWO_SIDED|95.0|-26.0|-15.0|||Regression, Linear|||Adjusted Difference Between Groups||-15|-26|<0.001
71896568|NCT01380093|143315667|SUPERIORITY_OR_OTHER||LS Mean Difference|168.6|||<|0.0001|TWO_SIDED|95.0|104.7|232.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||232.6|104.7|<0.0001
71896569|NCT01380093|143315667|SUPERIORITY_OR_OTHER||LS Mean Difference|475.4|||<|0.0001|TWO_SIDED|95.0|411.3|539.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||539.6|411.3|<0.0001
71845603|NCT05785832|143205896|SUPERIORITY||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.0|-11.0|||Regression, Linear|||Adjusted Difference Between Groups||-11|-17|<0.001
71845604|NCT05785832|143205897|SUPERIORITY||Mean Difference (Net)|-9.1|||<|0.001|TWO_SIDED|95.0|-11.7|-6.6|||Regression, Linear|||Adjusted Difference Between Groups||-6.6|-11.7|<0.001
71845605|NCT05785832|143205898|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4|||Regression, Linear|||Adjusted Difference Between Groups||-0.4|-1.0|<0.001
71845606|NCT05785832|143205899|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.4|0.1||A hierarchical procedure was used to control for the overall type I error. Since the P value for this outcome was more than 0.05, no additional P values are provided for subsequent secondary outcomes.|Regression, Linear|||Adjusted Difference Between Groups||0.1|-0.4|
71845607|NCT05785832|143205900|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04|||Regression, Linear|||Adjusted Difference Between Groups||0.04|-0.09|
71845608|NCT05785832|143205901|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.0|||Regression, Linear|||Adjusted Difference Between Groups||0.0|-0.1|
71845609|NCT05785832|143205902|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||Regression, Linear|||Adjusted Difference Between Groups||1.2|-0.5|
71845610|NCT05785832|143205903|SUPERIORITY||Difference in percent of participants.|12.0|||||TWO_SIDED|95.0|1.0|21.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||21|1|
71896570|NCT01380093|143315668|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5607|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.6|0.5607
71896571|NCT01380093|143315668|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.2|<0.0001
71896572|NCT01380093|143315668|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.0001|TWO_SIDED|95.0|1.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|1.0|<0.0001
71896573|NCT01380093|143315669|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-20.3|-10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-10.3|-20.3|<0.0001
71845611|NCT05785832|143205904|SUPERIORITY||Difference in percent of participants.|18.0|||||TWO_SIDED|95.0|2.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|2|
71896574|NCT01380093|143315669|SUPERIORITY_OR_OTHER||LS Mean Difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.3|16.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.2|6.3|<0.0001
71896575|NCT01380093|143315669|SUPERIORITY_OR_OTHER||LS Mean Difference|26.5|||<|0.0001|TWO_SIDED|95.0|21.5|31.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.5|21.5|<0.0001
71896576|NCT01380093|143315670|SUPERIORITY_OR_OTHER||LS Mean Difference|-47.7|||<|0.0001|TWO_SIDED|95.0|-59.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.9|-59.5|<0.0001
71896577|NCT01380093|143315670|SUPERIORITY_OR_OTHER||LS Mean Difference|28.3|||<|0.0001|TWO_SIDED|95.0|16.5|40.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||40.1|16.5|<0.0001
71845612|NCT05785832|143205905|SUPERIORITY||Difference in percent of participants.|23.0|||||TWO_SIDED|95.0|12.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|12|
71896578|NCT01380093|143315670|SUPERIORITY_OR_OTHER||LS Mean Difference|76.0|||<|0.0001|TWO_SIDED|95.0|64.2|87.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||87.8|64.2|<0.0001
71896579|NCT01380093|143315671|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.3|||<|0.0001|TWO_SIDED|95.0|-132.9|-85.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-85.6|-132.9|<0.0001
71896580|NCT01380093|143315671|SUPERIORITY_OR_OTHER||LS Mean Difference|67.0|||<|0.0001|TWO_SIDED|95.0|43.5|90.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.6|43.5|<0.0001
71845613|NCT05785832|143205906|SUPERIORITY||Difference in percent of participants.|25.0|||||TWO_SIDED|95.0|11.0|38.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||38|11|
71845614|NCT05785832|143205907|SUPERIORITY||Difference in percent of participants.|22.0|||||TWO_SIDED|95.0|11.0|33.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||33|11|
71845615|NCT05785832|143205908|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|10.0|32.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||32|10|
71845616|NCT05785832|143205909|SUPERIORITY||Difference in percent of participants.|21.0|||||TWO_SIDED|95.0|9.0|31.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||31|9|
71845617|NCT05785832|143205910|SUPERIORITY||Median Difference (Net)|10.0|||||TWO_SIDED|95.0|7.0|12.0||||||Adjusted Difference Between Groups||12|7|
71845618|NCT05785832|143205911|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.02|0.01||||||||0.01|-0.02|
71845619|NCT05785832|143205912|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.07|0.01||||||Adjusted Difference Between Groups||0.01|-0.07|
71845620|NCT05785832|143205913|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|95.0|-6.0|-2.7||||||Adjusted Difference Between Groups||-2.7|-6.0|
71845621|NCT05785832|143205914|SUPERIORITY||Mean Difference (Net)|-14.0|||||TWO_SIDED|95.0|-18.0|-10.0||||||Adjusted Difference Between Groups||-10|-18|
71845622|NCT05785832|143205915|SUPERIORITY||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-5.2|-2.7||||||Adjusted Difference Between Groups||-2.7|-5.2|
71845623|NCT05785832|143205916|SUPERIORITY||Difference in percent of participants.|16.0|||||TWO_SIDED|95.0|8.0|24.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||24|8|
71845624|NCT05785832|143205917|SUPERIORITY||Difference in percent of participants.|26.0|||||TWO_SIDED|95.0|12.0|41.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||41|12|
71845625|NCT05785832|143205918|SUPERIORITY||Difference in percent of participants.|34.0|||||TWO_SIDED|95.0|21.0|45.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||45|21|
71845626|NCT05785832|143205921|SUPERIORITY||Difference in percent of participants.|15.0|||||TWO_SIDED|95.0|8.0|22.0|||||Estimation represents the difference in percent of participants in each arm who achieved the outcome.|||22|8|
71845627|NCT05785832|143205922|SUPERIORITY||Mean Difference (Net)|-10.0|||||TWO_SIDED|95.0|-20.0|0.0||||||Adjusted Difference Between Groups.||0|-20|
71845628|NCT05785832|143205923|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||||||Adjusted Difference Between Groups.||3.4|-4.4|
71896581|NCT01380093|143315671|SUPERIORITY_OR_OTHER||LS Mean Difference|176.3|||<|0.0001|TWO_SIDED|95.0|152.6|199.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||199.9|152.6|<0.0001
71896582|NCT01380093|143315672|SUPERIORITY_OR_OTHER||LS Mean Difference|-190.8|||<|0.0001|TWO_SIDED|95.0|-234.2|-147.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-147.3|-234.2|<0.0001
71896583|NCT01380093|143315672|SUPERIORITY_OR_OTHER||LS Mean Difference|134.7|||<|0.0001|TWO_SIDED|95.0|91.5|178.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||178.0|91.5|<0.0001
71845629|NCT05785832|143205924|SUPERIORITY||Median Difference (Net)|1.5|||||TWO_SIDED|95.0|0.5|2.5||||||Adjusted Difference Between Groups.||2.5|0.5|
71845630|NCT05785832|143205925|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|-2.5|4.7||||||Adjusted Difference Between Groups.||4.7|-2.5|
71845631|NCT05785832|143205926|SUPERIORITY||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.7||||||Adjusted Difference Between Groups.||0.7|-3.4|
71845632|NCT05785832|143205927|SUPERIORITY||Median Difference (Net)|2.1|||||TWO_SIDED|95.0|0.5|3.7||||||Adjusted Difference Between Groups.||3.7|0.5|
71845633|NCT05785832|143205928|SUPERIORITY||Mean Difference (Net)|4.9|||||TWO_SIDED|95.0|-1.4|11.1||||||Adjusted Difference Between Groups.||11.1|-1.4|
71845634|NCT05785832|143205929|SUPERIORITY||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-45.0|4.0||||||Adjusted Difference Between Groups.||4|-45|
71845635|NCT03414684|143205937|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.88|TWO_SIDED|95.0|0.49|1.84|||Log Rank|stratified log rank test|Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A|||1.84|0.49|0.88
71845636|NCT03414684|143205938|SUPERIORITY||Odds Ratio (OR)|1.09||||1|TWO_SIDED|95.0|0.29|4.18|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A|||4.18|0.29|1
71845637|NCT03414684|143205940|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.49|TWO_SIDED|95.0|0.43|1.5|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.50|0.43|0.49
71896584|NCT01380093|143315672|SUPERIORITY_OR_OTHER||LS Mean Difference|325.5|||<|0.0001|TWO_SIDED|95.0|282.1|368.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||368.9|282.1|<0.0001
71896585|NCT01380093|143315673|SUPERIORITY_OR_OTHER||LS Mean Difference|-244.9|||<|0.0001|TWO_SIDED|95.0|-302.0|-187.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-187.7|-302.0|<0.0001
71896586|NCT01380093|143315673|SUPERIORITY_OR_OTHER||LS Mean Difference|166.5|||<|0.0001|TWO_SIDED|95.0|109.5|223.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||223.5|109.5|<0.0001
71896587|NCT01380093|143315673|SUPERIORITY_OR_OTHER||LS Mean Difference|411.4|||<|0.0001|TWO_SIDED|95.0|354.3|468.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||468.6|354.3|<0.0001
71845638|NCT03414684|143205941|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.32|3.43|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||3.43|0.32|1
71845639|NCT03414684|143205942|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.36|TWO_SIDED|95.0|0.13|2.12|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.12|0.13|0.36
71845640|NCT03414684|143205943|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.68|TWO_SIDED|95.0|0.43|3.43|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.43|0.43|0.68
71845641|NCT03414684|143205944|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.27|TWO_SIDED|95.0|0.18|1.62|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||1.62|0.18|0.27
71845642|NCT03414684|143205945|SUPERIORITY||Odds Ratio (OR)|0.81||||1|TWO_SIDED|95.0|0.08|7.78|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||7.78|0.08|1
71845643|NCT03414684|143205947|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.61|TWO_SIDED|95.0|0.26|2.16|||Log Rank|stratified log rank test|Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||2.16|0.26|0.61
71845644|NCT03414684|143205948|SUPERIORITY||Odds Ratio (OR)|0.79||||1|TWO_SIDED|95.0|0.1|5.93|||Fisher Exact||Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A|||5.93|0.10|1
71845645|NCT03414684|143205950|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.73|TWO_SIDED|95.0|0.14|3.89|||Log Rank||Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A|||3.89|0.14|0.73
71845646|NCT04038580|143205965|SUPERIORITY|||||||0.553||||||Statistical significance was set a-priori at p\<0.05|ANOVA|||The null hypothesis was that all sockets would have the same SCS||||0.553
71845647|NCT04038580|143205966|SUPERIORITY|Frustration sub-scale||||||0.536|||||||ANOVA|||The null hypothesis was that all sockets would be the same||||0.536
71845648|NCT04038580|143205966|SUPERIORITY|Perceived Response||||||0.598|||||||ANOVA|||||||0.598
71845649|NCT04038580|143205966|SUPERIORITY|Social Burden||||||0.072|||||||ANOVA|||||||0.072
71845650|NCT04038580|143205966|SUPERIORITY|Ambulation Sub-scale||||||0.018|||||||ANOVA|||||||0.018
71845651|NCT04038580|143205966|SUPERIORITY|Prosthesis Utility||||||0.037|||||||ANOVA|||||||0.037
71845652|NCT04038580|143205966|SUPERIORITY|Residual Limb Health||||||0.254|||||||ANOVA|||||||0.254
71845653|NCT04038580|143205966|SUPERIORITY|Appearance||||||0.032|||||||ANOVA|||||||0.032
71845654|NCT04038580|143205966|SUPERIORITY|Sounds||||||0.352|||||||ANOVA|||||||0.352
71896588|NCT01380093|143315674|SUPERIORITY_OR_OTHER||LS Mean Difference|-310.0|||<|0.0001|TWO_SIDED|95.0|-384.5|-235.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-235.5|-384.5|<0.0001
71896589|NCT01380093|143315674|SUPERIORITY_OR_OTHER||LS Mean Difference|185.2|||<|0.0001|TWO_SIDED|95.0|110.8|259.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||259.5|110.8|<0.0001
71896590|NCT01380093|143315674|SUPERIORITY_OR_OTHER||LS Mean Difference|495.1|||<|0.0001|TWO_SIDED|95.0|420.6|569.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||569.7|420.6|<0.0001
71896591|NCT01380093|143315675|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.5|||<|0.0001|TWO_SIDED|95.0|-38.7|-22.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-22.3|-38.7|<0.0001
71896592|NCT01380093|143315675|SUPERIORITY_OR_OTHER||LS Mean Difference|30.8|||<|0.0001|TWO_SIDED|95.0|22.6|39.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.0|22.6|<0.0001
71896593|NCT01380093|143315675|SUPERIORITY_OR_OTHER||LS Mean Difference|61.3|||<|0.0001|TWO_SIDED|95.0|53.1|69.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.5|53.1|<0.0001
71896594|NCT01380093|143315676|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.8671|TWO_SIDED|95.0|-1.0|0.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.8|-1.0|0.8671
71896595|NCT01380093|143315676|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.0001|TWO_SIDED|95.0|0.9|2.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.7|0.9|0.0001
71896596|NCT01380093|143315676|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.0|<0.0001
71896597|NCT01380093|143315677|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0|||<|0.0001|TWO_SIDED|95.0|-17.0|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-17.0|<0.0001
71896598|NCT01380093|143315677|SUPERIORITY_OR_OTHER||LS Mean Difference|8.8|||<|0.0001|TWO_SIDED|95.0|4.8|12.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||12.8|4.8|<0.0001
71896599|NCT01380093|143315677|SUPERIORITY_OR_OTHER||LS Mean Difference|21.8|||<|0.0001|TWO_SIDED|95.0|17.8|25.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||25.8|17.8|<0.0001
71896600|NCT01380093|143315678|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.3|||<|0.0001|TWO_SIDED|95.0|-55.3|-35.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-35.3|-55.3|<0.0001
71896601|NCT01380093|143315678|SUPERIORITY_OR_OTHER||LS Mean Difference|24.5|||<|0.0001|TWO_SIDED|95.0|14.6|34.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.5|14.6|<0.0001
71896602|NCT01380093|143315678|SUPERIORITY_OR_OTHER||LS Mean Difference|69.8|||<|0.0001|TWO_SIDED|95.0|59.9|79.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||79.8|59.9|<0.0001
71896603|NCT01380093|143315679|SUPERIORITY_OR_OTHER||LS Mean Difference|-109.1|||<|0.0001|TWO_SIDED|95.0|-129.3|-88.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-88.8|-129.3|<0.0001
71896604|NCT01380093|143315679|SUPERIORITY_OR_OTHER||LS Mean Difference|60.1|||<|0.0001|TWO_SIDED|95.0|39.9|80.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||80.4|39.9|<0.0001
71896605|NCT01380093|143315679|SUPERIORITY_OR_OTHER||LS Mean Difference|169.2|||<|0.0001|TWO_SIDED|95.0|148.9|189.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||189.5|148.9|<0.0001
71896606|NCT01380093|143315680|SUPERIORITY_OR_OTHER||LS Mean Difference|-207.0|||<|0.0001|TWO_SIDED|95.0|-242.0|-172.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-172.1|-242.0|<0.0001
71896607|NCT01380093|143315680|SUPERIORITY_OR_OTHER||LS Mean Difference|118.7|||<|0.0001|TWO_SIDED|95.0|83.9|153.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||153.5|83.9|<0.0001
71896608|NCT01380093|143315680|SUPERIORITY_OR_OTHER||LS Mean Difference|325.8|||<|0.0001|TWO_SIDED|95.0|290.8|360.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||360.7|290.8|<0.0001
71896609|NCT01380093|143315681|SUPERIORITY_OR_OTHER||LS Mean Difference|-268.2|||<|0.0001|TWO_SIDED|95.0|-313.2|-223.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-223.2|-313.2|<0.0001
71845655|NCT04038580|143205966|SUPERIORITY|Well-being||||||0.077|||||||ANOVA|||||||.077
71845656|NCT04038580|143205967|SUPERIORITY|||||||0.95|||||||ANOVA|general linear model with socket as fixed factor and participant as random factor||||||0.95
71845657|NCT04038580|143205968|SUPERIORITY|||||||0.853|||||||ANOVA|general linear model with sockets as fixed effect and subjects as random effect||||||.853
71845658|NCT04038580|143205969|SUPERIORITY|||||||0.565|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||0.565
71845659|NCT04038580|143205971|SUPERIORITY|||||||0.374|||||||ANOVA|general linear model with socket as fixed factor and subjects as random factor||||||.374
71845660|NCT04038580|143205973|SUPERIORITY|||||||0.574|||||||ANOVA|general linear model with socket as a fixed factor and subjects as a random factor||||||.574
71845661|NCT00310180|143205979|SUPERIORITY|Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.|Hazard Ratio (HR)|1.08||||0.13|TWO_SIDED|95.0|0.94|1.24||One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.|Regression, Cox|||This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.||1.24|0.94|0.13
71845662|NCT00310180|143205983|OTHER|Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis||||||0.004|||||||Regression, Cox|||Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups \<=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. \>25) in patients randomized to arms B and C||||0.004
71845663|NCT03147287|143205986|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.62|TWO_SIDED|90.0|0.79|1.55||We reported two-sided p-values corresponding to two-sided α level of 0.10. The test statistic and p-value were taken from the Cox proportional hazards model score test.|Log Rank|The SAP intended stratified tests and models, however one stratum was only 9 patients making implementation of stratification questionable.|We checked the proportional hazards assumption by visually assessing the plot of log( log(survival)) vs log of survival times according to treatment assignment for parallelism. This was done overall and according to stratum.|The primary objective was investigated by comparing the PFS distributions between two treatment arms using a logrank test with one-sided α level of 0.05 (H0: PFS1≤PFS2; HA: PFS1\>PFS2). Hazard ratios were estimated from a Cox PH model (F+P / F, so that HR\<1 indicates reduced hazard of PFS event with F+P), with two sided 90% CIs (Wald) to align with the design and testing.||1.55|0.79|0.62
71845664|NCT03147287|143205987|SUPERIORITY|||||||1||||||P-value is two sided, for hypothesis test with two-sided α=0.10|Fisher Exact|||The objective response was reported with two-sided 90% CI and compared between two treatment arms using a (unstratified) Fisher's exact test;||||1.000
71845665|NCT00705406|143206036|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.222|TWO_SIDED|95.0|0.723|1.188|||Wilcoxon-Gehan test statistic|P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.|||1.188|0.723|0.222
71845666|NCT00705406|143206037|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||van Elteren test|P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.||||||>0.05
71845667|NCT00705406|143206038|SUPERIORITY_OR_OTHER|||||||0.421|TWO_SIDED||||||van Elteren test|P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.||||||0.421
71845668|NCT00705406|143206039|SUPERIORITY_OR_OTHER|||||||0.885|TWO_SIDED||||||Wilcoxon-Gehan test statistic|P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.||||||0.885
71845669|NCT00705406|143206040|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.||||||0.306
71845670|NCT03732807|143206051|SUPERIORITY||Estimate of difference|29.11|||<|1e-06|TWO_SIDED|95.0|21.17|37.91|||Miettinen and Nurminen method|||||37.91|21.17|<0.000001
71845671|NCT03732807|143206051|SUPERIORITY||Estimate of difference|20.78|||<|1e-06|TWO_SIDED|95.0|13.65|29.18|||Miettinen and Nurminen method|||||29.18|13.65|<0.000001
71845672|NCT03732807|143206051|SUPERIORITY||Estimate of difference|21.85|||<|1e-06|TWO_SIDED|95.0|14.65|30.23|||Miettinen and Nurminen method|||||30.23|14.65|<0.000001
71845673|NCT03732807|143206051|SUPERIORITY||Estimate of difference|12.75||||0.000154|TWO_SIDED|95.0|6.69|20.36|||Miettinen and Nurminen method|||||20.36|6.69|0.000154
71845674|NCT03732807|143206052|SUPERIORITY||Estimate of difference|19.75|||<|1e-06|TWO_SIDED|95.0|11.91|27.59|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||27.59|11.91|<0.000001
71845675|NCT03732807|143206052|SUPERIORITY||Estimate of difference|11.33||||0.000526||95.0|4.93|17.74|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||17.74|4.93|0.000526
71845676|NCT03732807|143206052|SUPERIORITY||Estimate of difference|11.88||||0.000311||95.0|5.42|18.33|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||18.33|5.42|0.000311
71677409|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.203|||||TWO_SIDED|95.0|0.745|1.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.943|0.745|
71677410|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.496|||||TWO_SIDED|95.0|0.31|0.794||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.794|0.310|
71677411|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.4|||||TWO_SIDED|95.0|0.25|0.641||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.641|0.250|
71677412|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.954|||||TWO_SIDED|95.0|0.596|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.528|0.596|
71677413|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.481|||||TWO_SIDED|95.0|0.306|0.758||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.758|0.306|
71677414|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.449|||||TWO_SIDED|95.0|0.279|0.722||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.722|0.279|
71677415|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.631|||||TWO_SIDED|95.0|0.398|1.002||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.002|0.398|
71677416|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.807|||||TWO_SIDED|95.0|0.5|1.304||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.304|0.500|
71677417|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.924|||||TWO_SIDED|95.0|1.193|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.102|1.193|
71677418|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.97|||||TWO_SIDED|95.0|0.611|1.541||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.541|0.611|
71688668|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.92||0.323|TWO_SIDED|90.0|-0.64|2.5|||t-test, 2 sided|||Lung Perfusion||2.50|-0.64|0.3230
71677419|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.905|||||TWO_SIDED|95.0|0.561|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.460|0.561|
71677420|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.273|||||TWO_SIDED|95.0|0.798|2.03||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.030|0.798|
71688669|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.95||0.1717|TWO_SIDED|90.0|-0.29|2.97|||t-test, 2 sided|||Lung, Left Perfusion||2.97|-0.29|0.1717
71677421|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|2.383|||||TWO_SIDED|95.0|1.474|3.851||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.851|1.474|
71677422|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.202|||||TWO_SIDED|95.0|0.754|1.915||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.915|0.754|
71677423|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.12|||||TWO_SIDED|95.0|0.689|1.821||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.821|0.689|
71677424|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.576|||||TWO_SIDED|95.0|0.987|2.516||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.516|0.987|
71677425|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.504|||||TWO_SIDED|95.0|0.316|0.805||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.805|0.316|
71677426|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.47|||||TWO_SIDED|95.0|0.293|0.754||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.754|0.293|
71677427|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.662|||||TWO_SIDED|95.0|0.414|1.056||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.056|0.414|
71677428|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.932|||||TWO_SIDED|95.0|0.583|1.492||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.492|0.583|
71677429|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.312|||||TWO_SIDED|95.0|0.831|2.071||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.071|0.831|
71896610|NCT01380093|143315681|SUPERIORITY_OR_OTHER||LS Mean Difference|147.0|||<|0.0001|TWO_SIDED|95.0|102.1|191.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.9|102.1|<0.0001
71896611|NCT01380093|143315681|SUPERIORITY_OR_OTHER||LS Mean Difference|415.2|||<|0.0001|TWO_SIDED|95.0|370.2|460.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||460.2|370.2|<0.0001
71896612|NCT01380093|143315682|SUPERIORITY_OR_OTHER||LS Mean Difference|-336.0|||<|0.0001|TWO_SIDED|95.0|-395.4|-276.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-276.6|-395.4|<0.0001
71896613|NCT01380093|143315682|SUPERIORITY_OR_OTHER||LS Mean Difference|165.6|||<|0.0001|TWO_SIDED|95.0|106.4|224.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||224.8|106.4|<0.0001
71896614|NCT01380093|143315682|SUPERIORITY_OR_OTHER||LS Mean Difference|501.6|||<|0.0001|TWO_SIDED|95.0|442.2|561.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||561.0|442.2|<0.0001
71896615|NCT01380093|143315683|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-40.7|-26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-26.8|-40.7|<0.0001
71896616|NCT01380093|143315683|SUPERIORITY_OR_OTHER||LS Mean Difference|26.7|||<|0.0001|TWO_SIDED|95.0|19.7|33.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.6|19.7|<0.0001
71896617|NCT01380093|143315683|SUPERIORITY_OR_OTHER||LS Mean Difference|60.4|||<|0.0001|TWO_SIDED|95.0|53.4|67.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.4|53.4|<0.0001
71896618|NCT01380093|143315684|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.3345|TWO_SIDED|95.0|-0.4|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.4|0.3345
71896619|NCT01380093|143315684|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.5|3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.3|1.5|<0.0001
71896620|NCT01380093|143315684|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0|||<|0.0001|TWO_SIDED|95.0|1.1|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.8|1.1|<0.0001
71896621|NCT01380093|143315685|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.0453|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.0|-2.0|0.0453
71896622|NCT01380093|143315685|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.5637|TWO_SIDED|95.0|-0.7|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.3|-0.7|0.5637
71896623|NCT01380093|143315685|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.011|TWO_SIDED|95.0|0.3|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|0.3|0.0110
71896624|NCT01380093|143315686|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.9||||0.0041|TWO_SIDED|95.0|-8.2|-1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.6|-8.2|0.0041
71896625|NCT01380093|143315686|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.2178|TWO_SIDED|95.0|-1.2|5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.3|-1.2|0.2178
71896626|NCT01380093|143315686|SUPERIORITY_OR_OTHER||LS Mean Difference|7.0|||<|0.0001|TWO_SIDED|95.0|3.7|10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.3|3.7|<0.0001
71896627|NCT01380093|143315687|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.4||||0.0001|TWO_SIDED|95.0|-28.8|-9.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.9|-28.8|0.0001
71896628|NCT01380093|143315687|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9||||0.151|TWO_SIDED|95.0|-2.6|16.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||16.3|-2.6|0.1510
71896629|NCT01380093|143315687|SUPERIORITY_OR_OTHER||LS Mean Difference|26.2|||<|0.0001|TWO_SIDED|95.0|16.8|35.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.7|16.8|<0.0001
71896630|NCT01380093|143315688|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-75.9|-34.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-34.4|-75.9|<0.0001
71896631|NCT01380093|143315688|SUPERIORITY_OR_OTHER||LS Mean Difference|18.5||||0.0796|TWO_SIDED|95.0|-2.2|39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||39.2|-2.2|0.0796
71896632|NCT01380093|143315688|SUPERIORITY_OR_OTHER||LS Mean Difference|73.6|||<|0.0001|TWO_SIDED|95.0|52.9|94.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||94.4|52.9|<0.0001
71896633|NCT01380093|143315689|SUPERIORITY_OR_OTHER||LS Mean Difference|-82.8|||<|0.0001|TWO_SIDED|95.0|-112.9|-52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-52.7|-112.9|<0.0001
71896634|NCT01380093|143315689|SUPERIORITY_OR_OTHER||LS Mean Difference|26.9||||0.078|TWO_SIDED|95.0|-3.1|56.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||56.9|-3.1|0.0780
71896635|NCT01380093|143315689|SUPERIORITY_OR_OTHER||LS Mean Difference|109.7|||<|0.0001|TWO_SIDED|95.0|79.6|139.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||139.8|79.6|<0.0001
71896636|NCT01380093|143315690|SUPERIORITY_OR_OTHER||LS Mean Difference|-111.9|||<|0.0001|TWO_SIDED|95.0|-153.7|-70.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-70.2|-153.7|<0.0001
71896637|NCT01380093|143315690|SUPERIORITY_OR_OTHER||LS Mean Difference|33.9||||0.1089|TWO_SIDED|95.0|-7.8|75.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||75.5|-7.8|0.1089
71896638|NCT01380093|143315690|SUPERIORITY_OR_OTHER||LS Mean Difference|145.8|||<|0.0001|TWO_SIDED|95.0|104.1|187.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||187.5|104.1|<0.0001
71896639|NCT01380093|143315691|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.7|||<|0.0001|TWO_SIDED|95.0|-18.8|-8.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-8.6|-18.8|<0.0001
71677430|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.407|||||TWO_SIDED|95.0|0.88|2.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||2.249|0.880|
71677431|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|5.428|||||TWO_SIDED|95.0|4.0|7.365||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||7.365|4|
71896640|NCT01380093|143315691|SUPERIORITY_OR_OTHER||LS Mean Difference|6.0||||0.0215|TWO_SIDED|95.0|0.9|11.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.1|0.9|0.0215
71896641|NCT01380093|143315691|SUPERIORITY_OR_OTHER||LS Mean Difference|19.7|||<|0.0001|TWO_SIDED|95.0|14.6|24.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||24.8|14.6|<0.0001
71896642|NCT01380093|143315692|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.3||||0.0007|TWO_SIDED|95.0|-3.6|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-3.6|0.0007
71896643|NCT01380093|143315692|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3||||0.0455|TWO_SIDED|95.0|0.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.6|0.0|0.0455
71896644|NCT01380093|143315692|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6|||<|0.0001|TWO_SIDED|95.0|2.3|4.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.9|2.3|<0.0001
71896645|NCT01380093|143315693|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.3|-0.9|0.3749
71896646|NCT01380093|143315693|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.7939|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-0.5|0.7939
71896647|NCT01380093|143315693|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.2524|TWO_SIDED|95.0|-0.3|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.0|-0.3|0.2524
71896648|NCT01380093|143315694|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.1211|TWO_SIDED|95.0|-3.8|0.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.5|-3.8|0.1211
71896649|NCT01380093|143315694|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.1997|TWO_SIDED|95.0|-0.7|3.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.5|-0.7|0.1997
71896650|NCT01380093|143315694|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1||||0.0057|TWO_SIDED|95.0|0.9|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|0.9|0.0057
71677432|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.091|||||TWO_SIDED|95.0|0.804|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.481|0.804|
71896651|NCT01380093|143315695|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.8||||0.0057|TWO_SIDED|95.0|-16.7|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-16.7|0.0057
71677433|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.759|||||TWO_SIDED|95.0|0.559|1.031||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.031|0.559|
71677434|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.499|||||TWO_SIDED|95.0|2.577|4.751||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.751|2.577|
71677435|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.982|||||TWO_SIDED|95.0|0.722|1.334||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.334|0.722|
71677436|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.699|||||TWO_SIDED|95.0|0.513|0.95||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.95|0.513|
71677437|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.513|||||TWO_SIDED|95.0|1.846|3.421||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.421|1.846|
71677438|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.201|||||TWO_SIDED|95.0|0.149|0.272||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.272|0.149|
71688670|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|1.02||0.5031|TWO_SIDED|90.0|-1.05|2.43|||t-test, 2 sided|||Lung, Left Lower Lobe Perfusion||2.43|-1.05|0.5031
71814174|NCT03587142|143130637|SUPERIORITY||Mean Difference (Net)|1.01||||0.19|TWO_SIDED|95.0|-0.49|2.51||P value is nominal: no adjustments made from multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002.|ANCOVA|||Adjusted mean difference from differences (DoD) from the baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P value (2-sided) determined from a Wald Chi-Square test.||2.51|-0.49|0.19
71896652|NCT01380093|143315695|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5||||0.1918|TWO_SIDED|95.0|-2.3|11.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.4|-2.3|0.1918
71677439|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.14|||||TWO_SIDED|95.0|0.103|0.189||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.189|0.103|
71896653|NCT01380093|143315695|SUPERIORITY_OR_OTHER||LS Mean Difference|14.4|||<|0.0001|TWO_SIDED|95.0|7.5|21.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||21.2|7.5|<0.0001
71896654|NCT01380093|143315696|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.5||||0.0013|TWO_SIDED|95.0|-50.2|-12.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-12.9|-50.2|0.0013
71896655|NCT01380093|143315696|SUPERIORITY_OR_OTHER||LS Mean Difference|14.9||||0.1136|TWO_SIDED|95.0|-3.7|33.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.5|-3.7|0.1136
71896656|NCT01380093|143315696|SUPERIORITY_OR_OTHER||LS Mean Difference|46.5|||<|0.0001|TWO_SIDED|95.0|27.8|65.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||65.1|27.8|<0.0001
71896657|NCT01380093|143315697|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.6||||0.0006|TWO_SIDED|95.0|-83.2|-24.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-24.0|-83.2|0.0006
71896658|NCT01380093|143315697|SUPERIORITY_OR_OTHER||LS Mean Difference|23.2||||0.1207|TWO_SIDED|95.0|-6.3|52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||52.7|-6.3|0.1207
71688671|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|1.03||0.076|TWO_SIDED|90.0|0.15|3.65|||t-test, 2 sided|||Lung, Left Upper Lobe Perfusion||3.65|0.15|0.0760
71814175|NCT03587142|143130638|SUPERIORITY||Mean Difference (Net)|1.86||||0.02|TWO_SIDED|95.0|0.33|3.38||P value is nominal: no adjustments made for multiple comparisons. Bonferroni P-value threshold for the level of significance is \<=0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS depression score.||3.38|0.33|0.02
71814176|NCT03587142|143130639|SUPERIORITY||Mean Difference (Net)|0.76||||0.4|TWO_SIDED|95.0|-1.02|2.54||P values are nominal; no adjustments for multiple comparisons|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the HADS anxiety total score. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test||2.54|-1.02|0.40
71896659|NCT01380093|143315697|SUPERIORITY_OR_OTHER||LS Mean Difference|76.8|||<|0.0001|TWO_SIDED|95.0|47.3|106.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||106.4|47.3|<0.0001
71896660|NCT01380093|143315698|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.8||||0.0008|TWO_SIDED|95.0|-118.6|-33.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-33.0|-118.6|0.0008
71896661|NCT01380093|143315698|SUPERIORITY_OR_OTHER||LS Mean Difference|31.8||||0.141|TWO_SIDED|95.0|-10.8|74.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||74.5|-10.8|0.1410
71896662|NCT01380093|143315698|SUPERIORITY_OR_OTHER||LS Mean Difference|107.7|||<|0.0001|TWO_SIDED|95.0|64.9|150.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||150.5|64.9|<0.0001
71896663|NCT01380093|143315699|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.0|||<|0.0001|TWO_SIDED|95.0|-14.4|-5.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.6|-14.4|<0.0001
71896664|NCT01380093|143315699|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3||||0.0529|TWO_SIDED|95.0|-0.1|8.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.7|-0.1|0.0529
71896665|NCT01380093|143315699|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3|||<|0.0001|TWO_SIDED|95.0|9.9|18.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||18.7|9.9|<0.0001
71896666|NCT01380093|143315700|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8||||0.0806|TWO_SIDED|95.0|-3.8|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-3.8|0.0806
71896667|NCT01380093|143315700|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.2769|TWO_SIDED|95.0|-0.9|3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.1|-0.9|0.2769
71896668|NCT01380093|143315700|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9||||0.0056|TWO_SIDED|95.0|0.9|5.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.0|0.9|0.0056
71677440|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.645|||||TWO_SIDED|95.0|0.476|0.873||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.873|0.476|
71677441|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.181|||||TWO_SIDED|95.0|0.134|0.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.245|0.134|
71677442|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.129|||||TWO_SIDED|95.0|0.095|0.174||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.174|0.095|
71677443|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric Mean Ratio at day 29|0.463|||||TWO_SIDED|95.0|0.341|0.628||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.628|0.341|
71677444|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.696|||||TWO_SIDED|95.0|0.514|0.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||0.943|0.514|
71677445|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.207|||||TWO_SIDED|95.0|2.368|4.343||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||4.343|2.368|
71814177|NCT03587142|143130640|SUPERIORITY||Mean Difference (Net)|-0.21||||0.25|TWO_SIDED|95.0|-0.57|0.15||P value is nominal with no adjustment for multiple comparisons. The Bonferroni level of significance threshold is \<=0.002.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of PAGI-QOL total score.||0.15|-0.57|0.25
71677446|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.9|||||TWO_SIDED|95.0|0.665|1.218||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.218|0.665|
71677447|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.64|||||TWO_SIDED|95.0|0.472|0.868||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.868|0.472|
71688672|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.93||0.5465|TWO_SIDED|90.0|-1.02|2.16|||t-test, 2 sided|||Lung, Right Perfusion||2.16|-1.02|0.5465
71896669|NCT01380093|143315701|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.11|TWO_SIDED|95.0|-1.7|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-1.7|0.1100
71896670|NCT01380093|143315701|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.9421|TWO_SIDED|95.0|-1.0|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|-1.0|0.9421
71677448|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.303|||||TWO_SIDED|95.0|1.7|3.121||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.121|1.7|
71677449|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|4.608|||||TWO_SIDED|95.0|3.398|6.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||6.249|3.398|
71677450|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.293|||||TWO_SIDED|95.0|0.954|1.753||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.753|0.954|
71677451|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.92|||||TWO_SIDED|95.0|0.677|1.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||1.249|0.677|
71677452|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.31|||||TWO_SIDED|95.0|2.436|4.496||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.496|2.436|
71677453|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.281|||||TWO_SIDED|95.0|0.207|0.38||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.38|0.207|
71814178|NCT03587142|143130641|SUPERIORITY||Mean Difference (Net)|-1.98||||0.36|TWO_SIDED|95.0|-6.2|2.24|||ANCOVA|||Adjusted mean difference of differences (DoD) of change in outcome from baseline and 95% Confidence Intervals were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of outcome. P (2-sided) were determined from a Wald-Chi-Square test.||2.24|-6.20|0.36
71677454|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.2|||||TWO_SIDED|95.0|0.147|0.271||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.271|0.147|
71677455|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.718|||||TWO_SIDED|95.0|0.529|0.975||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.975|0.529|
71677456|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.712|||||TWO_SIDED|95.0|0.524|0.966||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||0.966|0.524|
71688673|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|1.08||0.9913|TWO_SIDED|90.0|-1.85|1.87|||t-test, 2 sided|||Lung, Right Lower Lobe Perfusion||1.87|-1.85|0.9913
71896671|NCT01380093|143315701|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.1266|TWO_SIDED|95.0|-0.2|1.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.7|-0.2|0.1266
71896672|NCT01380093|143315702|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.6||||0.0723|TWO_SIDED|95.0|-5.3|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.2|-5.3|0.0723
71677457|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.56|||||TWO_SIDED|95.0|1.886|3.474||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.||3.474|1.886|
71814179|NCT03587142|143130642|SUPERIORITY||Mean Difference (Net)|-2.07||||0.15|TWO_SIDED|95.0|-4.91|0.76||P value is nominal; no adjustments made for multiple comparisons Bonferroni p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||0.76|-4.91|0.15
71896673|NCT01380093|143315702|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1||||0.4515|TWO_SIDED|95.0|-1.7|3.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.8|-1.7|0.4515
71896674|NCT01380093|143315702|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6||||0.0121|TWO_SIDED|95.0|0.8|6.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.4|0.8|0.0121
71896675|NCT01380093|143315703|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.0||||0.0059|TWO_SIDED|95.0|-18.7|-3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.3|-18.7|0.0059
71896676|NCT01380093|143315703|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.28|TWO_SIDED|95.0|-3.5|11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||11.8|-3.5|0.2800
71896677|NCT01380093|143315703|SUPERIORITY_OR_OTHER||LS Mean Difference|15.1||||0.0002|TWO_SIDED|95.0|7.5|22.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||22.8|7.5|0.0002
71896678|NCT01380093|143315704|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.7||||0.0001|TWO_SIDED|95.0|-54.8|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-54.8|0.0001
71896679|NCT01380093|143315704|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2||||0.1488|TWO_SIDED|95.0|-4.8|31.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||31.2|-4.8|0.1488
71896680|NCT01380093|143315704|SUPERIORITY_OR_OTHER||LS Mean Difference|49.9|||<|0.0001|TWO_SIDED|95.0|31.8|67.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||67.9|31.8|<0.0001
71896681|NCT01380093|143315705|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.1|||<|0.0001|TWO_SIDED|95.0|-88.5|-31.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.6|-88.5|<0.0001
71896682|NCT01380093|143315705|SUPERIORITY_OR_OTHER||LS Mean Difference|20.4||||0.1556|TWO_SIDED|95.0|-8.0|48.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||48.7|-8.0|0.1556
71896683|NCT01380093|143315705|SUPERIORITY_OR_OTHER||LS Mean Difference|80.4|||<|0.0001|TWO_SIDED|95.0|52.0|108.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||108.9|52.0|<0.0001
71896684|NCT01380093|143315706|SUPERIORITY_OR_OTHER||LS Mean Difference|-84.0||||0.0001|TWO_SIDED|95.0|-124.8|-43.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-43.2|-124.8|0.0001
71896685|NCT01380093|143315706|SUPERIORITY_OR_OTHER||LS Mean Difference|27.4||||0.1826|TWO_SIDED|95.0|-13.3|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-13.3|0.1826
71896686|NCT01380093|143315706|SUPERIORITY_OR_OTHER||LS Mean Difference|111.4|||<|0.0001|TWO_SIDED|95.0|70.6|152.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||152.2|70.6|<0.0001
71677458|NCT00972816|142873239|NON_INFERIORITY_OR_EQUIVALENCE|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.597|||||TWO_SIDED|95.0|2.646|4.89||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other||4.89|2.646|
71677459|NCT01585324|142873247|SUPERIORITY_OR_OTHER|||||||0.8333|TWO_SIDED||||||ANCOVA|The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.||||||0.8333
71677460|NCT01585324|142873249|SUPERIORITY_OR_OTHER|||||||0.0867|TWO_SIDED||||||Fisher Exact|||||||0.0867
71677461|NCT01585324|142873251|SUPERIORITY_OR_OTHER|||||||0.6492|TWO_SIDED||||||ANCOVA|||||||0.6492
71677462|NCT01585324|142873253|SUPERIORITY_OR_OTHER|||||||0.0333|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0333
71677463|NCT03917472|142873274|SUPERIORITY|(1-sided)|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|0.89||0.099|TWO_SIDED|95.0|-0.6|2.9|||ANOVA|||||2.9|-0.6|0.099
71677464|NCT03917472|142873274|NON_INFERIORITY|(4-letter margin) (1-sided)|||||<|0.001|||||||ANOVA|||||||<0.001
71677465|NCT03917472|142873275|SUPERIORITY|(1-sided); Week 52|LS mean difference|-41.4|STANDARD_ERROR_OF_MEAN|8.94|<|0.001|TWO_SIDED|95.0|-58.9|-23.8|||ANOVA|||||-23.8|-58.9|<0.001
71677466|NCT03917472|142873276|SUPERIORITY|(1-sided) Week 52|Difference - %|20.0|||<|0.001|TWO_SIDED|95.0|12.5|28.6|||Clopper-Pearson exact method.|||||28.6|12.5|<0.001
71677467|NCT03917472|142873283|OTHER|Descriptive|Difference - %|9.3|||||TWO_SIDED|95.0|1.7|17.0|||Clopper-Pearson exact method|||≥ 5 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|1.7|
71677468|NCT03917472|142873283|OTHER|Descriptive|Difference - %|7.7|||||TWO_SIDED|95.0|-1.5|17.0|||Clopper-Pearson exact method|||≥ 10 letters gain from baseline or BCVA ≥ 84 letters at Week 52||17.0|-1.5|
71677469|NCT03917472|142873283|OTHER|Descriptive|Difference - %|5.5|||||TWO_SIDED|95.0|-2.7|14.3|||Clopper-Pearson exact method|||≥ 15 letters gain from baseline or BCVA ≥ 84 letters at Week 52||14.3|-2.7|
71677470|NCT03917472|142873284|OTHER|descriptive; week 12|Difference - %|8.3|||||TWO_SIDED|95.0|0.2|16.5|||Clopper-Pearson exact method|||||16.5|0.2|
71677471|NCT03917472|142873284|OTHER|descriptive; week 24|Difference - %|6.0|||||TWO_SIDED|95.0|-3.0|14.9|||Clopper-Pearson exact method|||||14.9|-3.0|
71677472|NCT03917472|142873284|NON_INFERIORITY|(10% margin); week 52|Difference - %|6.0||||0.002|TWO_SIDED|95.0|-3.9|16.1||(10% margin) (1-sided)|Clopper-Pearson exact method|||||16.1|-3.9|0.002
71677473|NCT03917472|142873285|OTHER|descriptive; week 12|Difference - %|2.0|||||TWO_SIDED|95.0|-2.5|6.6|||Clopper-Pearson exact method|||||6.6|-2.5|
71677474|NCT03917472|142873285|OTHER|descriptive; week 24|Difference - %|2.4|||||TWO_SIDED|95.0|-3.0|7.7|||Clopper-Pearson exact method|||||7.7|-3.0|
71896687|NCT01380093|143315707|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7|||<|0.0001|TWO_SIDED|95.0|-16.4|-7.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-7.0|-16.4|<0.0001
71677475|NCT03917472|142873285|OTHER|descriptive; week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.0|9.8|||Clopper-Pearson exact method|||||9.8|-2.0|
71677476|NCT01953601|142873306|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.1||||0.6734|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.6734
71677477|NCT01953601|142873306|SUPERIORITY||Difference in Least Squares Means (LSM)|0.4||||0.0141|TWO_SIDED|97.51|0.0|0.8|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.8|0.0|0.0141
71677478|NCT01953601|142873308|OTHER||Difference in % vs Placebo|4.32|||||TWO_SIDED|95.0|0.4|8.31|||||Difference in % = Arm A - Arm C|||8.31|0.40|
71677479|NCT01953601|142873308|OTHER||Difference in % vs Placebo|5.17|||||TWO_SIDED|95.0|1.33|9.09|||||Difference in % = Arm B - Arm C|||9.09|1.33|
71677480|NCT01953601|142873309|OTHER||Difference in % vs Placebo|2.08|||||TWO_SIDED|95.0|-0.84|5.1|||||Difference in % = Arm A - Arm C|||5.10|-0.84|
71677481|NCT01953601|142873309|OTHER||Difference in % vs Placebo|5.58|||||TWO_SIDED|95.0|2.35|8.99|||||Difference in % = Arm B - Arm C|||8.99|2.35|
71677482|NCT01953601|142873310|OTHER||Difference in % vs Placebo|-6.79|||||TWO_SIDED|95.0|-16.16|2.68|||||Difference in % = Arm A - Arm C|||2.68|-16.16|
71677483|NCT01953601|142873310|OTHER||Difference in % vs Placebo|-10.68|||||TWO_SIDED|95.0|-20.16|-1.04|||||Difference in % = Arm B - Arm C|||-1.04|-20.16|
71677484|NCT01953601|142873311|OTHER||Difference in % vs Placebo|-2.42|||||TWO_SIDED|95.0|-6.03|0.61|||||Difference in % = Arm A - Arm C|||0.61|-6.03|
71677485|NCT01953601|142873311|OTHER||Difference in % vs Placebo|-2.38|||||TWO_SIDED|95.0|-6.01|0.71|||||Difference in % = Arm B - Arm C|||0.71|-6.01|
71677486|NCT01953601|142873312|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.0222|TWO_SIDED|97.51|1.005|1.684|||Regression, Cox||HR = Arm A / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.684|1.005|0.0222
71677487|NCT01953601|142873312|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.005|TWO_SIDED|97.51|1.067|1.79|||Regression, Cox||HR = Arm B / Arm C||Based on Cox regression model with Efron's method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.|1.790|1.067|0.0050
71677488|NCT01953601|142873313|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9109|TWO_SIDED|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-0.3|0.9109
71677489|NCT01953601|142873313|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.3||||0.0824|TWO_SIDED|97.51|-0.1|0.7|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.7|-0.1|0.0824
71882217|NCT02831673|143283284|OTHER||Mean Difference (Net)|-26.67|||||TWO_SIDED|95.0|-110.64|57.3|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||57.30|-110.64|
71677490|NCT01953601|142873314|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.951|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9510
71882218|NCT02831673|143283284|OTHER||Mean Difference (Net)|4.44||||||95.0|-76.18|85.06|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||85.06|-76.18|
71882219|NCT02831673|143283284|OTHER||Mean Difference (Net)|24.96|||||TWO_SIDED|95.0|-60.68|110.59|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||110.59|-60.68|
71882220|NCT02831673|143283285|OTHER||Mean Difference (Net)|7.6|||||TWO_SIDED|95.0|-24.6|39.8|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||39.8|-24.6|
71882221|NCT02831673|143283285|OTHER||Mean Difference (Net)|3.0|||||TWO_SIDED|95.0|-59.8|65.9|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.|||65.9|-59.8|
71882222|NCT02831673|143283285|OTHER||Mean Difference (Net)|22.6|||||TWO_SIDED|95.0|-78.3|123.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||123.5|-78.3|
71882223|NCT02831673|143283285|OTHER||Mean Difference (Net)|5.2|||||TWO_SIDED|95.0|-24.7|35.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||35.1|-24.7|
71882224|NCT02831673|143283285|OTHER||Mean Difference (Net)|8.4|||||TWO_SIDED|95.0|-29.1|45.9|||||Age\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||45.9|-29.1|
71882225|NCT02831673|143283285|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-53.9|48.9|||||Age 35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||48.9|-53.9|
71882226|NCT02831673|143283285|OTHER||Mean Difference (Net)|17.7|||||TWO_SIDED|95.0|-74.6|110.1|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||110.1|-74.6|
71882227|NCT02831673|143283285|OTHER||Mean Difference (Net)|10.4|||||TWO_SIDED|95.0|-62.3|83.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||83.1|-62.3|
71882228|NCT02831673|143283285|OTHER||Mean Difference (Net)|5.6|||||TWO_SIDED|95.0|-25.6|36.9|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||36.9|-25.6|
71882229|NCT02831673|143283285|OTHER||Mean Difference (Net)|6.3|||||TWO_SIDED|95.0|-28.2|40.9|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||40.9|-28.2|
71882230|NCT02831673|143283285|OTHER||Mean Difference (Net)|-30.2|||||TWO_SIDED|95.0|-122.7|62.4|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||62.4|-122.7|
71882231|NCT02831673|143283285|OTHER||Mean Difference (Net)|49.2|||||TWO_SIDED|95.0|-36.3|134.7|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||134.7|-36.3|
71882232|NCT02831673|143283285|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-94.7|89.7|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.|||89.7|-94.7|
71882233|NCT02831673|143283286|OTHER||Mean Difference (Net)|1.9|||||TWO_SIDED|95.0|-34.5|38.2|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.2|-34.5|
71882234|NCT02831673|143283286|OTHER||Mean Difference (Net)|40.1|||||TWO_SIDED|95.0|-31.2|111.5|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.|||111.5|-31.2|
71882235|NCT02831673|143283286|OTHER||Mean Difference (Net)|-3.9|||||TWO_SIDED|95.0|-122.3|114.5|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||114.5|-122.3|
71677491|NCT01953601|142873314|SUPERIORITY||Difference in Least Squares Mean (LSM)|0.0||||0.9392|TWO_SIDED|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-0.2|0.9392
71677492|NCT01953601|142873315|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.4||||0.1133|TWO_SIDED|97.51|-1.0|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.2|-1.0|0.1133
71677493|NCT01953601|142873315|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.6||||0.031|TWO_SIDED|97.51|-1.2|0.0|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.0|-1.2|0.0310
71677494|NCT01953601|142873316|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.05|||<|0.0001|TWO_SIDED|97.51|-0.06|-0.04|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.04|-0.06|<0.0001
71677495|NCT01953601|142873316|SUPERIORITY||Difference in Least Squares Mean (LSM)|-0.06|||<|0.0001|TWO_SIDED|97.51|-0.07|-0.05|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.05|-0.07|<0.0001
71677496|NCT01953601|142873317|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.0||||0.096|TWO_SIDED|97.51|-2.4|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|0.4|-2.4|0.0960
71677497|NCT01953601|142873317|SUPERIORITY||Difference in Least Squares Mean (LSM)|-1.7||||0.011|TWO_SIDED|97.51|-3.2|-0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.|-0.2|-3.2|0.0110
71677498|NCT02991729|142873319|NON_INFERIORITY|The non-inferiority limit was 1 point on the questionnaire scale.||||||0.929||||||a priori threshold for statistical significance was p\<0.05.|Wilcoxon rank-sum|||||||0.929
71814180|NCT03587142|143130643|SUPERIORITY||Mean Difference (Net)|1.37||||0.76|TWO_SIDED|95.0|-7.51|10.25||P value is nominal: no adjustments made for multiple comparisons. Bonferrini p-value is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported. P (2-sided) determined from a Wald Chi-Square test.||10.25|-7.51|0.76
71814181|NCT03587142|143130644|SUPERIORITY||Mean Difference (Net)|-0.05||||0.1|TWO_SIDED|95.0|-0.12|0.01||Nominal P values; no adjustment for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) were computed using ANCOVA, regressing change in IMD from baseline to 4-weeks on treatment group and the baseline value of IMD. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.01|-0.12|0.10
71814182|NCT03587142|143130645|SUPERIORITY||Mean Difference (Net)|-21.51||||0.29|TWO_SIDED|95.0|-99.4|56.4||Nominal P values; no adjustments for multiple comparisons.|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of teh outcome. Wald 95% Confidence Limits are reported; P (2-sided) determined from a Wald Chi-Square test.||56.4|-99.4|0.29
71882236|NCT02831673|143283286|OTHER||Mean Difference (Net)|10.8|||||TWO_SIDED|95.0|-22.9|44.5|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||44.5|-22.9|
71882237|NCT02831673|143283286|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-35.0|49.6|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||49.6|-35.0|
71677499|NCT02991729|142873320|SUPERIORITY|||||||0.369|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion but prior to genetic counseling (first row, second column in above table).||||0.369
71882238|NCT02831673|143283286|OTHER||Mean Difference (Net)|-2.5|||||TWO_SIDED|95.0|-60.7|55.7|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||55.7|-60.7|
71882239|NCT02831673|143283286|OTHER||Mean Difference (Net)|41.6|||||TWO_SIDED|95.0|-61.2|144.5|||||Age\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||144.5|-61.2|
71882240|NCT02831673|143283286|OTHER||Mean Difference (Net)|18.8|||||TWO_SIDED|95.0|-64.2|101.8|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||101.8|-64.2|
71677500|NCT02991729|142873320|SUPERIORITY|||||||0.003|||||||Wilcoxon rank-sum|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict in the routine care group (after counseling only) to the experimental group following decision aid completion and genetic counseling (second row, second column in above table).||||0.003
71677501|NCT02991729|142873320|SUPERIORITY|||||||0.003|||||||Wilcoxon signed-rank|||Decisional conflict was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. This analysis compares decisional conflict pre-genetic counseling/post-decision aid to post-genetic counseling.||||0.003
71677502|NCT02230696|142873323|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.19|||||TWO_SIDED|90.0|84.77|104.52|||Trial and Error approach|||||104.52|84.77|
71677503|NCT02230696|142873324|EQUIVALENCE|provides 85% power of success|Equivalence ratio|94.68|||||TWO_SIDED|90.0|84.86|105.54|||Trial and Error approach|||||105.54|84.86|
71677504|NCT05225298|142873326|OTHER|||||||0.9||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.90
71677505|NCT05225298|142873327|OTHER|||||||0.94||||||A p-value of \< 0.05 would be considered statistically significant|log binomial model|||||||0.94
71677506|NCT05225298|142873328|OTHER|||||||0.053|||||||log binomial model|||||||0.053
71677507|NCT02223650|142873334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.01|TWO_SIDED|95.0|-1.42|-0.07||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment|Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group|||-0.07|-1.42|0.01
71814183|NCT03587142|143130646|SUPERIORITY||Mean Difference (Net)|0.09||||0.84|TWO_SIDED|95.0|-0.78|0.95||P value is nominal; no adjustments made for multiple comparisons. Bonferroni p-value \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to week 4 on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported: P (2-sided) determined from Wald Chi-Square test.||0.95|-0.78|0.84
71677508|NCT02223650|142873335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.14|TWO_SIDED|95.0|-0.68|0.19||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|||0.19|-0.68|0.14
71677509|NCT02223650|142873338|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0||||0.07|TWO_SIDED|95.0|-6.0|45.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||45|-6|0.07
71677510|NCT02223650|142873346|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.54|TWO_SIDED|95.0|-23.0|24.0||The p-value was not adjusted for multiple comparisons.|Chi-squared|||||24|-23|0.54
71677511|NCT00970632|142873372|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.1||||0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.|ANCOVA|||||||0.001
71896688|NCT01380093|143315707|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2||||0.0811|TWO_SIDED|95.0|-0.5|8.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||8.9|-0.5|0.0811
71677512|NCT00970632|142873372|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.023||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.023
71677513|NCT00970632|142873373|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.2|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
71677514|NCT00970632|142873373|SUPERIORITY_OR_OTHER||Difference in LS Means|-2.3|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
71677515|NCT00970632|142873374|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
71677516|NCT00970632|142873374|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.055
71677517|NCT00970632|142873375|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
71677518|NCT00970632|142873375|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.0||||0.026||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
71677519|NCT00970632|142873376|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.08||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.080
71677520|NCT00970632|142873376|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2||||0.118||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.118
71677521|NCT00970632|142873377|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.3||||0.022||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.022
71677522|NCT00970632|142873377|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.1||||0.546||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.546
71677523|NCT00970632|142873378|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
71677524|NCT00970632|142873378|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.5||||0.005||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.005
71677525|NCT00970632|142873379|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||<0.001
71814184|NCT03587142|143130647|SUPERIORITY||Mean Difference (Net)|-6.43||||0.27|TWO_SIDED|95.0|-17.9|5.03||P value is nominal|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Limits (CI) are reported; P (2-sided) determined from a Wald Chi-Square test.||5.03|-17.90|0.27
71814185|NCT03587142|143130648|SUPERIORITY||Mean Difference (Net)|-1.02||||0.74|TWO_SIDED|95.0|-6.93|4.89||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold for the level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. Wald 95% Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||4.89|-6.93|0.74
71814186|NCT03587142|143130649|SUPERIORITY||Mean Difference (Net)|0.03||||0.18|TWO_SIDED|95.0|-0.01|0.08|||ANCOVA|P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance \<0.002||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||0.08|-0.01|0.18
71814187|NCT03587142|143130650|SUPERIORITY||Mean Difference (Net)|-0.39||||0.97|TWO_SIDED|95.0|-20.42|19.64||P value is nominal: no adjustments made for multiple comparisons. Bonferroni p-value threshold level of significance is \<0.002|ANCOVA|||Adjusted mean difference of differences (DoD) from baseline were computed using ANCOVA, regressing change from baseline to 4-weeks on treatment group and baseline value of the outcome. 95% Wald Confidence Intervals are reported; P (2-sided) determined from a Wald Chi-Square test.||19.64|-20.42|0.97
71814188|NCT03587142|143130651|SUPERIORITY||Incident rate ratio|1.27||||0.64|TWO_SIDED|95.0|0.57|2.82||P values are nominal and not adjusted for multiple comparisons.|Exact poisson regression|||Event rates are computed by treatment arm by dividing the total adverse events over 4-weeks by the number of patient-months of follow-up to 4-weeks. Event rates are compared by treatment arm using an exact poisson regression for event rates.||2.82|0.57|0.64
71814189|NCT03587142|143130652|SUPERIORITY||Incident rate ratio|0.95||||0.54|TWO_SIDED|95.0|0.35|2.62||P values are nominal.|Fisher Exact|||A Fisher's Exact test was used for comparisons of events by treatment by severity grade. One patient in the Buspirone arm had 2 AEs during the trial; for analysis by severity grade the maximum severity grade was used.|An exact poisson regression stratified by severity level was used to compute the incident rate ratio and 95% Confidence Intervals for adverse events by severity level.|2.62|0.35|0.54
71814190|NCT03587142|143130653|SUPERIORITY|||||||1||||||P value is nominal.|Fisher Exact|||||||1.00
71814191|NCT03587142|143130654|SUPERIORITY||Incident rate ratio|1.03||||1|TWO_SIDED|95.0|0.0|40.36||P-values are nominal.|Exact poisson regression|||Event rates were computed by dividing the number of hospitalizations over 4-weeks by the number of person-years. An exact poisson regression was used to compare events by treatment group.||40.36|0|1.00
71814192|NCT03587142|143130655|SUPERIORITY|||||||0.52||||||Nominal P value.|Binomial probability test|2-sided test with probability of success=0||||||0.52
71814193|NCT00708435|143130663|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in effective hemostasis (%)|7.1|||||TWO_SIDED|95.0|-5.8|19.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with hemostasis.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.||19.9|-5.8|
71882241|NCT02831673|143283286|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|95.0|-27.4|43.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||43.1|-27.4|
71882242|NCT02831673|143283286|OTHER||Mean Difference (Net)|15.2|||||TWO_SIDED|95.0|-23.6|54.0|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||54.0|-23.6|
71677526|NCT00970632|142873379|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.9|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||<0.001
71677527|NCT00970632|142873380|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.8||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA|||||||0.003
71677528|NCT00970632|142873380|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.6||||0.026||95.0||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA|||||||0.026
71677529|NCT00970632|142873381|SUPERIORITY_OR_OTHER|||||||0.001||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.001
71677530|NCT00970632|142873381|SUPERIORITY_OR_OTHER|||||||0.114||95.0||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.114
71677531|NCT00970632|142873382|SUPERIORITY_OR_OTHER|||||||0.004||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.004
71845677|NCT03732807|143206052|SUPERIORITY||Estimate of difference|9.09||||0.002922||95.0|3.1|15.07|||Miettinen and Nurminen method|||A generalized linear mixed effect model without imputation using observed data up to Week 24 was used as the imputation model. A single complete imputed data set for Week 24 was analyzed using the Miettinen and Nurminen method as the analysis model.||15.07|3.10|0.002922
71845678|NCT03732807|143206053|SUPERIORITY||Estimate of difference|20.24|||<|1e-06||95.0|13.23|28.49|||Miettinen and Nurminen method|||||28.49|13.23|<0.000001
71845679|NCT03732807|143206053|SUPERIORITY||Estimate of difference|11.68||||0.000337||95.0|5.82|19.07|||Miettinen and Nurminen method|||||19.07|5.82|0.000337
71845680|NCT03732807|143206053|SUPERIORITY||Estimate of difference|12.17||||0.000228||95.0|6.27|19.53|||Miettinen and Nurminen method|||||19.53|6.27|0.000228
71845681|NCT03732807|143206053|SUPERIORITY||Estimate of difference|9.39||||0.001875|TWO_SIDED|95.0|3.86|16.46|||Miettinen and Nurminen method|||||16.46|3.86|0.001875
71845682|NCT03732807|143206054|SUPERIORITY||Estimate of difference|42.96|||<|1e-06|TWO_SIDED|95.0|31.68|54.25|||Miettinen and Nurminen method|||||54.25|31.68|<0.000001
71845683|NCT03732807|143206054|SUPERIORITY||Estimate of difference|36.18|||<|1e-06|TWO_SIDED|95.0|25.22|47.14|||Miettinen and Nurminen method|||||47.14|25.22|<0.000001
71845684|NCT03732807|143206054|SUPERIORITY||Estimate of difference|39.96|||<|1e-06|TWO_SIDED|95.0|28.85|51.06|||Miettinen and Nurminen method|||||51.06|28.85|<0.000001
71677532|NCT00970632|142873382|SUPERIORITY_OR_OTHER|||||||0.452||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate \[total IPSS \<20\]; severe \[total IPSS ≥20\]).||||||0.452
71677533|NCT00970632|142873383|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-4.4||||0.005||||||The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.005
71688674|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|1.7||0.3837|TWO_SIDED|90.0|-1.39|4.4|||t-test, 2 sided|||Lung, Right Middle Lobe Perfusion||4.40|-1.39|0.3837
71845685|NCT03732807|143206054|SUPERIORITY||Estimate of difference|32.72|||<|1e-06|TWO_SIDED|95.0|21.95|43.5|||Miettinen and Nurminen method|||||43.50|21.95|<0.000001
71845686|NCT04200664|143206085|OTHER|Kendall tau b correlation analysis test was performed between the number of cognitive domains affected and the both ears 3-frequency pure tone average (at 0.5/1/2kHz) or both ears 4-frequency pure tone average (at 0.5/1/2/4kHz).|Kendall Tau-b|0.462||||0.176|TWO_SIDED||||||Kendall tau-b|Kendall tau b non-parametric correlation analysis was performed.||||||0.176
71845687|NCT03775486|143206114|OTHER||Hazard Ratio (HR)|0.76||||0.074|TWO_SIDED|95.0|0.57|1.02|||Log Rank|||||1.02|0.57|0.074
71845688|NCT03775486|143206114|OTHER||Median|7.2|||||TWO_SIDED|95.0|5.3|7.9||||||Median progression-free survival (months)||7.9|5.3|
71845689|NCT03775486|143206114|OTHER||Median|5.3|||||TWO_SIDED|95.0|3.7|5.8||||||Median progression-free survival (months)||5.8|3.7|
71845690|NCT03775486|143206115|OTHER||Hazard Ratio (HR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36|||Log Rank|||||1.36|0.59|0.604
71845691|NCT03775486|143206115|OTHER||Median|17.4|||||TWO_SIDED|95.0|14.1||NA = insufficient number of participants with events|||||Median overall survival (months)|||14.1|
71845692|NCT03775486|143206115|OTHER||Median overall survival (months)|11.8|||||TWO_SIDED|95.0|11.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value|Median overall survival (months)|||11.8|
71845693|NCT03775486|143206117|OTHER|Median duration of response (months)|Median duration of response|6.5|||||TWO_SIDED|95.0|6.5||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||6.5|
71677534|NCT00970632|142873383|SUPERIORITY_OR_OTHER||Median of Treatment Group Differences|-2.2||||0.457||||||The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.||||||0.457
71677535|NCT00970632|142873384|SUPERIORITY_OR_OTHER||Difference in LS Means|4.0|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||<0.001
71677536|NCT00970632|142873384|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.4||||0.699||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA|||||||0.699
71677537|NCT00970632|142873385|SUPERIORITY_OR_OTHER|||||||0.009||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.009
71677538|NCT00970632|142873385|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.014
71677539|NCT00970632|142873388|SUPERIORITY_OR_OTHER|||||||0.303||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.||||||0.303
71677540|NCT00970632|142873388|SUPERIORITY_OR_OTHER|||||||0.146||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.||||||0.146
71677541|NCT00748189|142873466|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.45|0.72|||Log Rank||Hazard ratios are obtained using the Pike estimator.|||0.72|0.45|<0.001
71677542|NCT00748189|142873469|OTHER||Hazard Ratio (HR)|0.88||||0.363|TWO_SIDED|95.0|0.65|1.17|||Log Rank||hazard ratios are obtained using the Pike estimator. A hazard ratio \<1 indicates a lower risk with O+CHL treatment compared with chlorambucil|||1.17|0.65|0.363
71677543|NCT00748189|142873482|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.71|||||TWO_SIDED|90.0|0.53|0.94|||||Ratio of Cmax/Dose is the ratio of dose-normalized chlorambucil Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.94|0.53|
71677544|NCT00748189|142873482|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.79|||||TWO_SIDED|90.0|0.63|0.99|||||Ratio of Cmax/Dose is the ratio of dose-normalized PAAM Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||0.99|0.63|
71845694|NCT03775486|143206117|OTHER|Median duration of response (months)|Median duration of response|3.8|||||TWO_SIDED|95.0|3.8||NA = insufficient number of participants with events||||The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value||||3.8|
71677545|NCT00748189|142873483|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|1.04|||||TWO_SIDED|90.0|0.77|1.4|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized chlorambucil AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.40|0.77|
71677546|NCT00748189|142873483|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized chlorambucil AUC(0-inf) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-inf)/Dose|1.11|||||TWO_SIDED|90.0|0.82|1.5|||||Ratio of AUC(0-inf)/Dose is the ratio of dose-normalized chlorambucil AUC(0-inf) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.50|0.82|
71677547|NCT00748189|142873483|NON_INFERIORITY_OR_EQUIVALENCE|Comparability of dose-normalized PAAM AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|0.89|||||TWO_SIDED|90.0|0.72|1.1|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized PAAM AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).|||1.10|0.72|
71677548|NCT03320850|142873491|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.635||0.0845|TWO_SIDED|95.0|-0.15|2.35|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.35|-0.15|0.0845
71845695|NCT03775486|143206118|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.07|2.0||||||||2.00|0.07|
71845696|NCT03775486|143206118|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.7||NA = insufficient number of participants with events|||||Median progression-free survival (months)|||1.7|
71677549|NCT03320850|142873491|SUPERIORITY||Least Squares Mean Difference|1.83|STANDARD_ERROR_OF_MEAN|0.633||0.0041|TWO_SIDED|95.0|0.59|3.08|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||3.08|0.59|0.0041
71677550|NCT03320850|142873491|SUPERIORITY||Least Squares Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.632||0.06|TWO_SIDED|95.0|-0.05|2.44|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.44|-0.05|0.0600
71677551|NCT03320850|142873491|SUPERIORITY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|0.631||0.1702|TWO_SIDED|95.0|-0.37|2.11|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|The null hypothesis is that there is no difference between each (BOTOX® and Hydrogel admixture group) and (placebo and Hydrogel admixture) in the mean change from Baseline in daily average number of UIEs at Week 12.||2.11|-0.37|0.1702
71677552|NCT03320850|142873493|SUPERIORITY||Least Square Mean|0.73|STANDARD_ERROR_OF_MEAN|0.617||0.2361|TWO_SIDED|95.0|-0.48|1.95|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.95|-0.48|0.2361
71677553|NCT03320850|142873493|SUPERIORITY||Least Square Mean|0.78|STANDARD_ERROR_OF_MEAN|0.608||0.1985|TWO_SIDED|95.0|-0.41|1.98|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.98|-0.41|0.1985
71677554|NCT03320850|142873493|SUPERIORITY||Least Square Mean|0.64|STANDARD_ERROR_OF_MEAN|0.607||0.2923|TWO_SIDED|95.0|-0.56|1.84|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.84|-0.56|0.2923
71814194|NCT00708435|143130664|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was -(minus)10%. If the lower limit of the 2-sided 95% CI was \>-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated 'effective' in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in the decrease of INR (%)|52.6|||||TWO_SIDED|95.0|39.4|65.9||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. No P-value is entered as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|95% confidence interval|Farrington and Manning's method was used to estimate the 95% CI for the difference in the percentage of participants with a rapid decrease of the INR.|Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.||65.9|39.4|
71814195|NCT03502616|143130712|SUPERIORITY||Difference in percentage|27.08|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|15.89|38.28|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via Cochran-Mantel-Haenszel (CMH) approach.||38.28|15.89|<0.0001
71814196|NCT03502616|143130713|SUPERIORITY||Difference in percentage|28.17|STANDARD_ERROR_OF_MEAN|5.06|<|0.0001|TWO_SIDED|95.0|18.26|38.09|||Cochran-Mantel-Haenszel|||Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.09|18.26|<0.0001
71814197|NCT03502616|143130720|SUPERIORITY||Difference in percentage|18.28|STANDARD_ERROR_OF_MEAN|4.7||0.0001|TWO_SIDED|95.0|9.06|27.5|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||27.50|9.06|0.0001
71814198|NCT03502616|143130720|SUPERIORITY||Difference in percentage|31.35|STANDARD_ERROR_OF_MEAN|5.47|<|0.0001|TWO_SIDED|95.0|20.64|42.06|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.06|20.64|<0.0001
71814199|NCT03502616|143130720|SUPERIORITY||Difference in percentage|32.24|STANDARD_ERROR_OF_MEAN|5.57|<|0.0001|TWO_SIDED|95.0|21.32|43.17|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||43.17|21.32|<0.0001
71814200|NCT03502616|143130720|SUPERIORITY||Difference in percentage|34.61|STANDARD_ERROR_OF_MEAN|5.6|<|0.0001|TWO_SIDED|95.0|23.63|45.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.58|23.63|<0.0001
71896689|NCT01380093|143315707|SUPERIORITY_OR_OTHER||LS Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.1|20.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||20.6|11.1|<0.0001
71677555|NCT03320850|142873493|SUPERIORITY||Least Square Mean|0.54|STANDARD_ERROR_OF_MEAN|0.609||0.3769|TWO_SIDED|95.0|-0.66|1.74|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||1.74|-0.66|0.3769
71677556|NCT03320850|142873494|SUPERIORITY||Least Square Mean|-7.05|STANDARD_ERROR_OF_MEAN|13.107||0.5911|TWO_SIDED|95.0|-32.87|18.77|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||18.77|-32.87|0.5911
71677557|NCT03320850|142873494|SUPERIORITY||Least Square Mean|-8.0|STANDARD_ERROR_OF_MEAN|12.956||0.5375|TWO_SIDED|95.0|-33.52|17.52|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||17.52|-33.52|0.5375
71677558|NCT03320850|142873494|SUPERIORITY||Least Square Mean|-1.33|STANDARD_ERROR_OF_MEAN|12.764||0.9173|TWO_SIDED|95.0|-26.47|23.81|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||23.81|-26.47|0.9173
71677559|NCT03320850|142873494|SUPERIORITY||Least Square Mean|9.33|STANDARD_ERROR_OF_MEAN|12.981||0.473|TWO_SIDED|95.0|-16.24|34.9|||ANCOVA||Least square estimates and contrast t-test were used to compare specified treatment groups and were based on ANCOVA model with Baseline value as covariate and treatment group, sex (male, female) as factors.|||34.90|-16.24|0.4730
71814201|NCT03502616|143130720|SUPERIORITY||Difference in percentage|3.65|STANDARD_ERROR_OF_MEAN|5.9||0.536|TWO_SIDED|95.0|-7.92|15.22|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.22|-7.92|0.5360
71896690|NCT01380093|143315708|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5||||0.0007|TWO_SIDED|95.0|-3.8|-1.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.1|-3.8|0.0007
71896691|NCT01380093|143315708|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.1631|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.3|-0.4|0.1631
71896692|NCT01380093|143315708|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|||<|0.0001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.8|2.1|<0.0001
71896693|NCT01380093|143315709|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2||||0.2117|TWO_SIDED|95.0|-3.1|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.7|-3.1|0.2117
71677560|NCT01424514|142873500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.6|0.36||||||Placebo vs SB-705498 12 mg for 1 h in WM 0-60 TSS||0.36|-0.60|
71677561|NCT01424514|142873500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.45|0.51||||||Placebo vs SB-705498 12 mg for 24 h in WM 0-60 TSS||0.51|-0.45|
71677562|NCT01424514|142873500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.58|0.51||||||Placebo vs SB-705498 12 mg for 1 h in Maximum TSS||0.51|-0.58|
71677563|NCT01424514|142873500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.51|0.72||||||Placebo vs SB-705498 12 mg for 24 h in Maximum TSS||0.72|-0.51|
71677564|NCT01424514|142873502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.3|0.54||||||Placebo vs SB-705498 12 mg for WM 0-60 TSS||0.54|-0.30|
71814202|NCT03502616|143130720|SUPERIORITY||Difference in percentage|3.83|STANDARD_ERROR_OF_MEAN|5.63||0.4971|TWO_SIDED|95.0|-7.22|14.87|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.87|-7.22|0.4971
71677565|NCT01424514|142873502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.39|0.57||||||Placebo vs SB-705498 12 mg for Maximum TSS||0.57|-0.39|
71677566|NCT01424514|142873506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.14|0.08||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 sneezing||0.08|-0.14|
71677567|NCT01424514|142873506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.13|0.09||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 sneezing||0.09|-0.13|
71814203|NCT03502616|143130720|SUPERIORITY||Difference in percentage|1.58|STANDARD_ERROR_OF_MEAN|5.65||0.7792|TWO_SIDED|95.0|-9.49|12.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.66|-9.49|0.7792
71677568|NCT01424514|142873506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-0.2|0.11||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 sneezing||0.11|-0.20|
71896694|NCT01380093|143315709|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.0345|TWO_SIDED|95.0|0.2|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|0.2|0.0345
71896695|NCT01380093|143315709|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0011|TWO_SIDED|95.0|1.4|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.2|1.4|0.0011
71677569|NCT01424514|142873506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.28|0.14||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum sneezing||0.14|-0.28|
71896696|NCT01380093|143315710|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.2||||0.0002|TWO_SIDED|95.0|-18.4|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-6.0|-18.4|0.0002
71896697|NCT01380093|143315710|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4||||0.0081|TWO_SIDED|95.0|2.3|14.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.6|2.3|0.0081
71896698|NCT01380093|143315710|SUPERIORITY_OR_OTHER||LS Mean Difference|20.6|||<|0.0001|TWO_SIDED|95.0|14.4|26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||26.8|14.4|<0.0001
71896699|NCT01380093|143315711|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-55.6|-20.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.8|-55.6|<0.0001
71896700|NCT01380093|143315711|SUPERIORITY_OR_OTHER||LS Mean Difference|34.4||||0.0002|TWO_SIDED|95.0|17.0|51.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||51.7|17.0|0.0002
71896701|NCT01380093|143315711|SUPERIORITY_OR_OTHER||LS Mean Difference|72.6|||<|0.0001|TWO_SIDED|95.0|55.2|90.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||90.0|55.2|<0.0001
71677570|NCT01424514|142873506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.15|0.13||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum sneezing||0.13|-0.15|
71896702|NCT01380093|143315712|SUPERIORITY_OR_OTHER||LS Mean Difference|-100.3|||<|0.0001|TWO_SIDED|95.0|-142.2|-58.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-58.4|-142.2|<0.0001
71896703|NCT01380093|143315712|SUPERIORITY_OR_OTHER||LS Mean Difference|93.9|||<|0.0001|TWO_SIDED|95.0|52.1|135.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||135.7|52.1|<0.0001
71896704|NCT01380093|143315712|SUPERIORITY_OR_OTHER||LS Mean Difference|194.2|||<|0.0001|TWO_SIDED|95.0|152.3|236.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||236.1|152.3|<0.0001
71677571|NCT01424514|142873506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.16||||||Placebo vs SB-705498 12 mg for Day 1, 24 h in Maximum sneezing||0.16|-0.20|
71677572|NCT01424514|142873507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026|||TWO_SIDED|95.0|-0.03|0.07||||||Placebo vs SB-705498 12 mg for Day 1, 2 h in AR||0.07|-0.03|
71677573|NCT01424514|142873507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.027|||TWO_SIDED|95.0|-0.13|-0.02||||||Placebo vs SB-705498 12 mg for Day 14, 2 h in AR||-0.02|-0.13|
71677574|NCT01424514|142873507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.04|0.08||||||Placebo vs SB-705498 12 mg for Day 14, 25 h in AR||0.08|-0.04|
71677575|NCT01424514|142873508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.26||||||Placebo vs SB-705498 12 mg for Day 14 in AR||0.26|-0.36|
71677576|NCT01424514|142873509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.06|0.6||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 TOSS||0.60|-0.06|
71677577|NCT01424514|142873509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.32|0.53||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 TOSS||0.53|-0.32|
71677578|NCT01424514|142873509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.22|0.63||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 TOSS||0.63|-0.22|
71896705|NCT01380093|143315713|SUPERIORITY_OR_OTHER||LS Mean Difference|-147.4|||<|0.0001|TWO_SIDED|95.0|-205.1|-89.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-89.6|-205.1|<0.0001
71896706|NCT01380093|143315713|SUPERIORITY_OR_OTHER||LS Mean Difference|134.1|||<|0.0001|TWO_SIDED|95.0|76.5|191.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||191.7|76.5|<0.0001
71896707|NCT01380093|143315713|SUPERIORITY_OR_OTHER||LS Mean Difference|281.5|||<|0.0001|TWO_SIDED|95.0|223.7|339.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||339.2|223.7|<0.0001
71896708|NCT01380093|143315714|SUPERIORITY_OR_OTHER||LS Mean Difference|-201.4|||<|0.0001|TWO_SIDED|95.0|-279.3|-123.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-123.6|-279.3|<0.0001
71896709|NCT01380093|143315714|SUPERIORITY_OR_OTHER||LS Mean Difference|169.1|||<|0.0001|TWO_SIDED|95.0|91.5|246.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||246.7|91.5|<0.0001
71896710|NCT01380093|143315714|SUPERIORITY_OR_OTHER||LS Mean Difference|370.5|||<|0.0001|TWO_SIDED|95.0|292.7|448.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||448.4|292.7|<0.0001
71896711|NCT01380093|143315715|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.4|||<|0.0001|TWO_SIDED|95.0|-23.8|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.0|-23.8|<0.0001
71896712|NCT01380093|143315715|SUPERIORITY_OR_OTHER||LS Mean Difference|25.7|||<|0.0001|TWO_SIDED|95.0|18.3|33.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||33.1|18.3|<0.0001
71896713|NCT01380093|143315715|SUPERIORITY_OR_OTHER||LS Mean Difference|42.1|||<|0.0001|TWO_SIDED|95.0|34.7|49.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||49.5|34.7|<0.0001
71677579|NCT01424514|142873509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-0.3|0.68||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum TOSS||0.68|-0.30|
71677580|NCT01424514|142873509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.34|0.86||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum TOSS||0.86|-0.34|
71677581|NCT01424514|142873509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-0.15|0.73||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in Maximum TOSS||0.73|-0.15|
71677582|NCT02653170|142873526|SUPERIORITY||difference-in-differences (DID) p-value|0.025||||0.025|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p\<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.025
71677583|NCT02653170|142873527|SUPERIORITY||difference-in-differences (DID) p-value|0.562||||0.562|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.562
71677584|NCT02653170|142873528|SUPERIORITY|||||||0.789||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.789
71677585|NCT02653170|142873529|SUPERIORITY||difference-in-differences (DID) p-value|0.042||||0.042|TWO_SIDED|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis||The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.042
71677586|NCT02653170|142873530|SUPERIORITY|||||||0.993||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model \[i.e., 2 degree freedom test of the interaction between intervention group\*time\]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group \* time interaction term.||||0.993
71677587|NCT00507819|142873566|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Regression, Linear|||||||0.73
71677588|NCT00507819|142873567|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||Regression, Linear|||||||0.37
71677589|NCT00507819|142873568|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Linear|||||||0.05
71677590|NCT00507819|142873569|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.04
71677591|NCT03452488|142873570|SUPERIORITY|||||||0.2437|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic.||||0.2437
71677592|NCT03452488|142873570|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic||||0.2000
71677593|NCT03452488|142873570|SUPERIORITY|||||||0.324|TWO_SIDED|95.0|||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.3240
71677594|NCT03452488|142873570|SUPERIORITY|Gait Speed Based on Adjusted Bayesian Imputation||||||0.5123|||||||Adjusted Bayesian Imputation|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on adjusted Bayesian Imputation||||0.5123
71677595|NCT03452488|142873570|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.6920
71677596|NCT03452488|142873570|SUPERIORITY|||||||0.085|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic based on MI and Adjusted Bayesian Imputation||||0.0850
71677597|NCT03452488|142873571|SUPERIORITY|||||||0.9408|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9408
71677598|NCT03452488|142873571|SUPERIORITY|||||||0.9485|TWO_SIDED|95.0|||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-score based on Mixed Model Analysis||||0.9485
71677599|NCT03452488|142873571|SUPERIORITY|||||||0.9848|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.9848
71677600|NCT03452488|142873571|SUPERIORITY|||||||0.5017|||||||Mixed Models Analysis|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Physical Function Domain (PF-10) Sub-Score Based on Adjusted Bayesian Imputation||||0.5017
71677601|NCT03452488|142873572|SUPERIORITY|||||||0.52|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.5200
71814204|NCT03502616|143130720|SUPERIORITY||Difference in percentage|5.22|STANDARD_ERROR_OF_MEAN|5.8||0.3685|TWO_SIDED|95.0|-6.15|16.58|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.58|-6.15|0.3685
71814205|NCT03502616|143130721|SUPERIORITY||Difference in percentage|6.12|STANDARD_ERROR_OF_MEAN|3.19||0.0548|TWO_SIDED|95.0|-0.13|12.37|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||12.37|-0.13|0.0548
71814206|NCT03502616|143130721|SUPERIORITY||Difference in percentage|23.43|STANDARD_ERROR_OF_MEAN|4.15|<|0.0001|TWO_SIDED|95.0|15.3|31.56|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.56|15.30|<0.0001
71814207|NCT03502616|143130721|SUPERIORITY||Difference in percentage|28.56|STANDARD_ERROR_OF_MEAN|4.54|<|0.0001|TWO_SIDED|95.0|19.66|37.47|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.47|19.66|<0.0001
71814208|NCT03502616|143130721|SUPERIORITY||Difference in percentage|31.18|STANDARD_ERROR_OF_MEAN|5.02|<|0.0001|TWO_SIDED|95.0|21.34|41.02|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.02|21.34|<0.0001
71814209|NCT03502616|143130721|SUPERIORITY||Difference in percentage|6.29|STANDARD_ERROR_OF_MEAN|5.98||0.2926|TWO_SIDED|95.0|-5.43|18.01|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.01|-5.43|0.2926
71814210|NCT03502616|143130721|SUPERIORITY||Difference in percentage|6.37|STANDARD_ERROR_OF_MEAN|5.97||0.2856|TWO_SIDED|95.0|-5.32|18.06|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.06|-5.32|0.2856
71814211|NCT03502616|143130721|SUPERIORITY||Difference in percentage|7.83|STANDARD_ERROR_OF_MEAN|5.97||0.1894|TWO_SIDED|95.0|-3.87|19.54|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||19.54|-3.87|0.1894
71814212|NCT03502616|143130721|SUPERIORITY||Difference in percentage|5.59|STANDARD_ERROR_OF_MEAN|6.04||0.3544|TWO_SIDED|95.0|-6.24|17.43|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach||17.43|-6.24|0.3544
71814213|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.85|-0.57|||Mixed Models Analysis|||Week 2: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.57|-0.85|<0.0001
71814214|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-1.07|-0.74|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.07|<0.0001
71814215|NCT03502616|143130722|SUPERIORITY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-1.25|-0.87|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.87|-1.25|<0.0001
71814216|NCT03502616|143130722|SUPERIORITY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.096|<|0.0001|TWO_SIDED|95.0|-1.28|-0.9|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.90|-1.28|<0.0001
71814217|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|-1.16|-0.79|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.79|-1.16|<0.0001
71814218|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.103||0.0623|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||Week 24: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.40|0.0623
71814219|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.106||0.0836|TWO_SIDED|95.0|-0.39|0.02|||Mixed Models Analysis|||Week 32: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.39|0.0836
71845697|NCT03775486|143206118|OTHER||Median (months)|3.7|||||TWO_SIDED|95.0|1.2|16.6||||||Median progression-free survival (months)||16.6|1.2|
71845698|NCT03775486|143206120|OTHER||Estimated difference in adjusted mean|-0.51|||||TWO_SIDED|95.0|-4.47|3.46||||||EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.||3.46|-4.47|
71845699|NCT03775486|143206120|OTHER||Estimated difference in adjusted mean|0.95|||||TWO_SIDED|95.0|-4.81|6.71||||||EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.||6.71|-4.81|
71845700|NCT03775486|143206120|OTHER||Estimated difference in adjusted mean|-2.26|||||TWO_SIDED|95.0|-6.39|1.88||||||EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.||1.88|-6.39|
71845701|NCT03775486|143206122|OTHER||Estimated difference in adjusted mean|1.64|||||TWO_SIDED|95.0|-2.2|5.47||||||EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.||5.47|-2.20|
71677602|NCT03452488|142873572|SUPERIORITY|||||||0.3577|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (dominant hand)||||0.3577
71677603|NCT03452488|142873572|SUPERIORITY|||||||0.9237|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.9237
71677604|NCT03452488|142873572|SUPERIORITY|||||||0.7629|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test at Month 6 Based on Multiple Imputation (dominant hand)||||0.7629
71896714|NCT01380093|143315716|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4||||0.0253|TWO_SIDED|95.0|-2.6|-0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.2|-2.6|0.0253
71896715|NCT01380093|143315716|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.6|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.0|1.6|<0.0001
71896716|NCT01380093|143315716|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2|||<|0.0001|TWO_SIDED|95.0|3.0|5.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.4|3.0|<0.0001
71896717|NCT01380093|143315717|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1||||0.0062|TWO_SIDED|95.0|-3.7|-0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.6|-3.7|0.0062
71677605|NCT03452488|142873572|SUPERIORITY|||||||0.5695|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Change from Baseline in Handgrip Strength Test (left hand)||||0.5695
71677606|NCT03452488|142873572|SUPERIORITY|||||||0.3523|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Left hand)||||0.3523
71677607|NCT03452488|142873572|SUPERIORITY|||||||0.5652|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.5652
71677608|NCT03452488|142873572|SUPERIORITY|||||||0.2472|||||||ANCOVA|||Analysis of data collected from baseline to 6 months, or baseline to 9 months due to pandemic in Handgrip Strength Test (Right hand)||||0.2472
71677609|NCT03452488|142873573|SUPERIORITY|||||||0.9859||||||Statistical Analysis of Change from Baseline in ALM|ANCOVA|||||||0.9859
71677610|NCT03452488|142873573|SUPERIORITY|||||||0.404|||||||ANCOVA|||Statistical Analysis of Change from Baseline in ALM||||0.4040
71677611|NCT03452488|142873574|SUPERIORITY|||||||0.1219|||||||Regression, Logistic|||||||0.1219
71677612|NCT03452488|142873574|SUPERIORITY|||||||0.052|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0520
71677613|NCT03452488|142873575|SUPERIORITY|||||||0.8917|||||||ANCOVA|||||||0.8917
71896718|NCT01380093|143315717|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.4998|TWO_SIDED|95.0|-1.0|2.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.0|-1.0|0.4998
71896719|NCT01380093|143315717|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7||||0.0008|TWO_SIDED|95.0|1.1|4.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.2|1.1|0.0008
71896720|NCT01380093|143315718|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.0||||0.0009|TWO_SIDED|95.0|-11.1|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.0|-11.1|0.0009
71896721|NCT01380093|143315718|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2||||0.2693|TWO_SIDED|95.0|-1.8|6.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||6.3|-1.8|0.2693
71896722|NCT01380093|143315718|SUPERIORITY_OR_OTHER||LS Mean Difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.3|13.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||13.3|5.3|<0.0001
71896723|NCT01380093|143315719|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.2||||0.0042|TWO_SIDED|95.0|-27.2|-5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-5.3|-27.2|0.0042
71896724|NCT01380093|143315719|SUPERIORITY_OR_OTHER||LS Mean Difference|8.7||||0.1139|TWO_SIDED|95.0|-2.2|19.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||19.6|-2.2|0.1139
71677614|NCT03452488|142873575|SUPERIORITY||Mean Difference (Final Values)|-4.999|STANDARD_ERROR_OF_MEAN|10.2172||0.6317|TWO_SIDED|95.0|-26.777|16.778|||ANCOVA|||||16.778|-26.777|0.6317
71677615|NCT03452488|142873576|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
71677616|NCT03452488|142873576|SUPERIORITY|||||||0.0543|||||||Mixed Models Analysis|||||||0.0543
71677617|NCT03452488|142873577|SUPERIORITY|||||||0.8824|||||||ANCOVA|||||||0.8824
71677618|NCT03452488|142873577|SUPERIORITY|||||||0.1578|||||||ANCOVA|||||||0.1578
71677619|NCT03452488|142873578|SUPERIORITY|||||||0.0511|||||||ANCOVA|||||||0.0511
71677620|NCT03452488|142873578|SUPERIORITY|||||||0.2771|||||||ANCOVA|||||||0.2771
71677621|NCT03452488|142873579|SUPERIORITY|||||||0.8084|||||||Mixed Models Analysis|||||||0.8084
71677622|NCT03452488|142873579|SUPERIORITY|||||||0.7266|||||||Mixed Models Analysis|||||||0.7266
71677623|NCT03452488|142873580|SUPERIORITY|||||||0.2312|||||||Mixed Models Analysis|||||||0.2312
71677624|NCT03452488|142873580|SUPERIORITY|||||||0.2701|||||||Mixed Models Analysis|||||||0.2701
71677625|NCT03452488|142873581|SUPERIORITY|||||||0.8934|||||||ANCOVA|||||||0.8934
71677626|NCT03452488|142873581|SUPERIORITY|||||||0.3526|||||||ANCOVA|||||||0.3526
71677627|NCT00834639|142873602|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|97.36||||||90.0|93.68|101.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||101.18|93.68|
71896725|NCT01380093|143315719|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0|||<|0.0001|TWO_SIDED|95.0|14.1|35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||35.9|14.1|<0.0001
71896726|NCT01380093|143315720|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.9|||<|0.0001|TWO_SIDED|95.0|-42.1|-27.7||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-27.7|-42.1|<0.0001
71896727|NCT01380093|143315720|SUPERIORITY_OR_OTHER||LS Mean Difference|27.2|||<|0.0001|TWO_SIDED|95.0|20.1|34.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||34.4|20.1|<0.0001
71896728|NCT01380093|143315720|SUPERIORITY_OR_OTHER||LS Mean Difference|62.1|||<|0.0001|TWO_SIDED|95.0|54.9|69.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||69.4|54.9|<0.0001
71896729|NCT01380093|143315721|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.1||||0.0039|TWO_SIDED|95.0|-58.5|-11.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.7|-58.5|0.0039
71896730|NCT01380093|143315721|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3||||0.1026|TWO_SIDED|95.0|-4.0|42.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||42.7|-4.0|0.1026
71677628|NCT00834639|142873603|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.59||||||90.0|97.07|104.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104.24|97.07|
71677629|NCT00834639|142873604|NON_INFERIORITY_OR_EQUIVALENCE|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.36||||||90.0|97.35|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||103.46|97.35|
71677630|NCT03382834|142873611|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)||||||0.68
71677631|NCT03382834|142873613|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||||||0.73
71896731|NCT01380093|143315721|SUPERIORITY_OR_OTHER||LS Mean Difference|54.4|||<|0.0001|TWO_SIDED|95.0|31.0|77.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||77.8|31.0|<0.0001
71896732|NCT01380093|143315722|SUPERIORITY_OR_OTHER||LS Mean Difference|-43.3||||0.0051|TWO_SIDED|95.0|-73.1|-13.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.5|-73.1|0.0051
71896733|NCT01380093|143315722|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3||||0.0941|TWO_SIDED|95.0|-4.4|55.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||55.0|-4.4|0.0941
71896734|NCT01380093|143315722|SUPERIORITY_OR_OTHER||LS Mean Difference|68.6|||<|0.0001|TWO_SIDED|95.0|38.8|98.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||98.4|38.8|<0.0001
71896735|NCT01380093|143315723|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0||||0.0083|TWO_SIDED|95.0|-85.0|-13.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-13.1|-85.0|0.0083
71896736|NCT01380093|143315723|SUPERIORITY_OR_OTHER||LS Mean Difference|32.3||||0.0766|TWO_SIDED|95.0|-3.5|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||68.1|-3.5|0.0766
71896737|NCT01380093|143315723|SUPERIORITY_OR_OTHER||LS Mean Difference|81.3|||<|0.0001|TWO_SIDED|95.0|45.4|117.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||117.3|45.4|<0.0001
71896738|NCT01380093|143315724|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.0||||0.0018|TWO_SIDED|95.0|-12.9|-3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.1|-12.9|0.0018
71896739|NCT01380093|143315724|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8||||0.0527|TWO_SIDED|95.0|-0.1|9.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||9.7|-0.1|0.0527
71677632|NCT00977314|142873632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_DEVIATION|1.0|<|0.001|||||||t-test, 2 sided|||The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).||||<0.001
71677633|NCT00288600|142873644|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Chi-squared, Corrected|||Need of Exchange transfusion following the AAP criteria||||0.765
71814220|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.108||0.0205|TWO_SIDED|95.0|-0.47|-0.04|||Mixed Models Analysis|||Week 40: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-0.47|0.0205
71814221|NCT03502616|143130722|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.108||0.0614|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|||Week 48: Analysis performed using Mixed model for repeated measures (MMRM) which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.01|-0.42|0.0614
71896740|NCT01380093|143315724|SUPERIORITY_OR_OTHER||LS Mean Difference|12.8|||<|0.0001|TWO_SIDED|95.0|7.9|17.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17.7|7.9|<0.0001
71677634|NCT03600194|142873645|SUPERIORITY|||||||0.019|||||||Mixed Models Analysis|Design\*Therapy interaction term||||||.019
71814222|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-1.15|-0.7|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.15|<0.0001
71814223|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.121|<|0.0001|TWO_SIDED|95.0|-1.16|-0.68|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.68|-1.16|<0.0001
71814224|NCT03502616|143130723|SUPERIORITY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.4|-0.63|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.63|-1.40|<0.0001
71814225|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.115|<|0.0001|TWO_SIDED|95.0|-1.19|-0.74|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.74|-1.19|<0.0001
71814226|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.2|-0.72|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.72|-1.20|<0.0001
71814227|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.073||0.4731|TWO_SIDED|95.0|-0.2|0.09|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.20|0.4731
71814228|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.094||0.4055|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.11|-0.26|0.4055
71814229|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.111||0.2648|TWO_SIDED|95.0|-0.34|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.34|0.2648
71814230|NCT03502616|143130723|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.099||0.5558|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.25|0.5558
71814231|NCT03502616|143130724|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.513||0.0001|TWO_SIDED|95.0|-3.03|-1.01|||ANCOVA|||Week 16: Analysis performed using Analysis of covariance (ANCOVA) model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-1.01|-3.03|0.0001
71814232|NCT03502616|143130724|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.567||0.027|TWO_SIDED|95.0|-2.38|-0.14|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-2.38|0.0270
71814233|NCT03502616|143130725|SUPERIORITY||LS mean difference|2.22|STANDARD_ERROR_OF_MEAN|0.841||0.0088|TWO_SIDED|95.0|0.56|3.88|||ANCOVA|||Week 16, Physical Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.88|0.56|0.0088
71896741|NCT01380093|143315725|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.3986|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-1.4|0.3986
71896742|NCT01380093|143315725|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.0023|TWO_SIDED|95.0|0.6|2.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.5|0.6|0.0023
71896743|NCT01380093|143315725|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9||||0.0002|TWO_SIDED|95.0|1.0|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.0|0.0002
71896744|NCT01380093|143315726|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.2||||0.0029|TWO_SIDED|95.0|-18.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-18|0.0029
71896745|NCT01380093|143315726|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1||||0.0286|TWO_SIDED|95.0|1.0|15.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||15|1|0.0286
71896746|NCT01380093|143315726|SUPERIORITY_OR_OTHER||LS Mean Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.0|27.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||27|12|<0.0001
71677635|NCT05270395|142873690|SUPERIORITY||Odds Ratio (OR)|8.02||||0.02|TWO_SIDED|95.0|1.38|46.69|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||46.69|1.38|0.02
71677636|NCT05270395|142873691|SUPERIORITY||Odds Ratio (OR)|1.35||||0.63|TWO_SIDED|95.0|0.4|4.56|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||4.56|0.40|0.63
71677637|NCT05270395|142873692|SUPERIORITY||Odds Ratio (OR)|0.29||||0.13|TWO_SIDED|95.0|0.06|1.46|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||1.46|0.06|0.13
71896747|NCT01380093|143315727|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.0||||0.005|TWO_SIDED|95.0|-22.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4|-22|0.0050
71896748|NCT01380093|143315727|SUPERIORITY_OR_OTHER||LS Mean Difference|8.2||||0.07|TWO_SIDED|95.0|-1.0|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||17|-1|0.0700
71896749|NCT01380093|143315727|SUPERIORITY_OR_OTHER||LS Mean Difference|21.2|||<|0.0001|TWO_SIDED|95.0|12.0|30.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||30|12|<0.0001
71896750|NCT01380093|143315728|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|||<|0.0001|TWO_SIDED|95.0|0.5|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.9|0.5|<0.0001
71896751|NCT01380093|143315728|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-0.3|-0.8|<0.0001
71896752|NCT01380093|143315728|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.0|-1.5|<0.0001
71896753|NCT01380093|143315729|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4|||<|0.0001|TWO_SIDED|95.0|1.9|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||2.9|1.9|<0.0001
71896754|NCT01380093|143315729|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.3|-2.2|<0.0001
71896755|NCT01380093|143315729|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|||<|0.0001|TWO_SIDED|95.0|-4.6|-3.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-3.6|-4.6|<0.0001
71896756|NCT01380093|143315730|SUPERIORITY_OR_OTHER||LS Mean Difference|4.9|||<|0.0001|TWO_SIDED|95.0|3.9|5.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||5.8|3.9|<0.0001
71896757|NCT01380093|143315730|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.3|-4.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-4.3|-6.3|<0.0001
71896758|NCT01380093|143315730|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.1|||<|0.0001|TWO_SIDED|95.0|-11.1|-9.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-9.2|-11.1|<0.0001
71896759|NCT01380093|143315731|SUPERIORITY_OR_OTHER||LS Mean Difference|8.6|||<|0.0001|TWO_SIDED|95.0|6.6|10.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||10.7|6.6|<0.0001
71896760|NCT01380093|143315731|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.8|||<|0.0001|TWO_SIDED|95.0|-15.9|-11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-11.8|-15.9|<0.0001
71896761|NCT01380093|143315731|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-24.5|-20.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-20.4|-24.5|<0.0001
71677638|NCT05270395|142873693|SUPERIORITY||Odds Ratio (OR)|0.54||||0.4|TWO_SIDED|95.0|0.13|2.24|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||2.24|0.13|0.40
71677639|NCT05270395|142873694|SUPERIORITY||Odds Ratio (OR)|2.22||||0.29|TWO_SIDED|95.0|0.51|9.62|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.62|0.51|0.29
71677640|NCT05270395|142873695|SUPERIORITY||Odds Ratio (OR)|3.55||||0.07|TWO_SIDED|95.0|0.88|14.32|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||14.32|0.88|0.07
71814234|NCT03502616|143130725|SUPERIORITY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|0.939||0.0016|TWO_SIDED|95.0|1.15|4.85|||ANCOVA|||Week 16, Role-Physical: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.85|1.15|0.0016
71814235|NCT03502616|143130725|SUPERIORITY||LS mean difference|4.46|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|2.69|6.23|||ANCOVA|||Week 16, Bodily Pain: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||6.23|2.69|<0.0001
71814236|NCT03502616|143130725|SUPERIORITY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|0.781|<|0.0001|TWO_SIDED|95.0|1.7|4.78|||ANCOVA|||Week 16, General Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.78|1.70|<0.0001
71814237|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.098||0.1065|TWO_SIDED|95.0|-0.38|3.94|||ANCOVA|||Week 16, Vitality: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.94|-0.38|0.1065
71845702|NCT03775486|143206122|OTHER||Estimated difference in adjusted mean|3.22|||||TWO_SIDED|95.0|-1.46|7.9||||||EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.||7.90|-1.46|
71845703|NCT05256797|143206168|SUPERIORITY||Cox Proportional Hazard|0.69|||||TWO_SIDED|95.0|0.66|0.71||||||Hazard ratio||0.71|0.66|
71845704|NCT05325294|143206181|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.38% with a margin of 0.4%.|Mean difference from baseline to exit|-0.1||||0.133|TWO_SIDED|95.0|-0.2|0.1|||t-test, 1 sided||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||0.1|-0.2|0.133
71845705|NCT05325294|143206181|NON_INFERIORITY|The overall mean change in HbA1c from baseline to end of 3-month study period. The mean change will be estimated and compared to a threshold of -0.5% with a margin of 0.4%.|Mean difference from baseline to exit|-0.4|||<|0.001|TWO_SIDED|95.0|-0.6|-0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the differences of HbA1c from baseline to exit were summarized for this endpoint|||-0.3|-0.6|<0.001
71845706|NCT05325294|143206182|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
71845707|NCT05325294|143206182|NON_INFERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% with a margin of -7.5% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
71845708|NCT05325294|143206183|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.71% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.5|0.3|<0.001
71845709|NCT05325294|143206183|NON_INFERIORITY|The mean % of time in hypoglycemia (\< 54 mg/dL) will be estimated and compared to a threshold of 0.86% with a margin of 2% and a significance level of 0.025 (one-sided).|Mean of Final Value|0.2|||<|0.001|TWO_SIDED|95.0|0.2|0.3|||Wilcoxon (Mann-Whitney)||This is one arm study, the Percent of Time in Hypoglycemia (\< 54 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||0.3|0.2|<0.001
71845710|NCT05325294|143206184|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 65.3% and a significance level of 0.025 (one-sided).|Mean of Final Value|68.6|||<|0.001|TWO_SIDED|95.0|66.6|70.7|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||70.7|66.6|<0.001
71845711|NCT05325294|143206184|SUPERIORITY|The mean % of time in range (TIR 70-180 mg/dL) will be estimated and compared to a threshold of 73.7% and a significance level of 0.025 (one-sided).|Mean of Final Value|77.6|||<|0.001|TWO_SIDED|95.0|75.7|79.4|||t-test, 1 sided||This is one arm study, the Percent of Time in Range (TIR70-180 mg/dL) from the last 6-7 weeks of 3 month study period was summarized for this endpoint.|||79.4|75.7|<0.001
71896762|NCT01380093|143315732|SUPERIORITY_OR_OTHER||LS Mean Difference|11.7|||<|0.0001|TWO_SIDED|95.0|8.7|14.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||14.7|8.7|<0.0001
71896763|NCT01380093|143315732|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.0001|TWO_SIDED|95.0|-24.5|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-18.6|-24.5|<0.0001
71896764|NCT01380093|143315732|SUPERIORITY_OR_OTHER||LS Mean Difference|-33.2|||<|0.0001|TWO_SIDED|95.0|-36.2|-30.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-30.2|-36.2|<0.0001
71896765|NCT01380093|143315733|SUPERIORITY_OR_OTHER||LS Mean Difference|17.5|||<|0.0001|TWO_SIDED|95.0|11.6|23.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||23.3|11.6|<0.0001
71896766|NCT01380093|143315733|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.7|||<|0.0001|TWO_SIDED|95.0|-43.6|-31.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-31.9|-43.6|<0.0001
71896767|NCT01380093|143315733|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.2|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-49.3|-61.1|<0.0001
71677641|NCT05270395|142873696|SUPERIORITY||Odds Ratio (OR)|3.93||||0.09|TWO_SIDED|95.0|0.82|18.89|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||18.89|0.82|0.09
71896768|NCT01380093|143315734|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|||<|0.0001|TWO_SIDED|95.0|0.8|1.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.4|0.8|<0.0001
71814238|NCT03502616|143130725|SUPERIORITY||LS mean difference|2.96|STANDARD_ERROR_OF_MEAN|1.059||0.0055|TWO_SIDED|95.0|0.88|5.05|||ANCOVA|||Week 16, Social Functioning: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.05|0.88|0.0055
71814239|NCT03502616|143130725|SUPERIORITY||LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|1.289||0.1084|TWO_SIDED|95.0|-0.46|4.61|||ANCOVA|||Week 16, Role-Emotional: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||4.61|-0.46|0.1084
71814240|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|1.124||0.3379|TWO_SIDED|95.0|-1.13|3.29|||ANCOVA|||Week 16, Mental Health: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.29|-1.13|0.3379
71814241|NCT03502616|143130725|SUPERIORITY||LS mean difference|3.55|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|95.0|2.09|5.02|||ANCOVA|||Week 16, Physical Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||5.02|2.09|<0.0001
71814242|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|1.158||0.2529|TWO_SIDED|95.0|-0.95|3.61|||ANCOVA|||Week 16, Mental Component Summary: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||3.61|-0.95|0.2529
71896769|NCT01380093|143315734|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-1.5|-2.1|<0.0001
71896770|NCT01380093|143315734|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||-2.6|-3.2|<0.0001
71896771|NCT01380093|143315735|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.0262|TWO_SIDED|95.0|0.3|4.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||4.6|0.3|0.0262
71896772|NCT01380093|143315735|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9||||0.418|TWO_SIDED|95.0|-1.3|3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||3.0|-1.3|0.4180
71896773|NCT01380093|143315735|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.1479|TWO_SIDED|95.0|-3.7|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.6|-3.7|0.1479
71896774|NCT01380093|143315736|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21||||0.0181|TWO_SIDED|90.0|0.07|0.35|||Mixed Models Analysis|||Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.35|0.07|0.0181
71896775|NCT01380093|143315737|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.75|||<|0.0001|TWO_SIDED|90.0|0.68|0.83|||Mixed Models Analysis|||Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.83|0.68|<0.0001
71896776|NCT01380093|143315738|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.77||||0.0004|TWO_SIDED|90.0|0.69|0.86|||Mixed Models Analysis|||Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.86|0.69|0.0004
71814243|NCT03502616|143130725|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|0.964||0.3744|TWO_SIDED|95.0|-1.04|2.76|||Mixed Models Analysis|||Week 48, Physical Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.76|-1.04|0.3744
71814244|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.083||0.2091|TWO_SIDED|95.0|-0.77|3.5|||Mixed Models Analysis|||Week 48, Role-Physical: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.50|-0.77|0.2091
71814245|NCT03502616|143130725|SUPERIORITY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|1.146||0.0654|TWO_SIDED|95.0|-0.14|4.38|||Mixed Models Analysis|||Week 48, Bodily Pain: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.38|-0.14|0.0654
71814246|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|0.968||0.21|TWO_SIDED|95.0|-0.69|3.12|||Mixed Models Analysis|||Week 48, General Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.12|-0.69|0.2100
71814247|NCT03502616|143130725|SUPERIORITY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|1.248||0.6568|TWO_SIDED|95.0|-1.9|3.01|||Mixed Models Analysis|||Week 48, Vitality: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.90|0.6568
71814248|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|1.152||0.2288|TWO_SIDED|95.0|-0.88|3.66|||Mixed Models Analysis|||Week 48, Social Functioning: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.66|-0.88|0.2288
71814249|NCT03502616|143130725|SUPERIORITY||LS mean difference|0.85|STANDARD_ERROR_OF_MEAN|1.25||0.4955|TWO_SIDED|95.0|-1.61|3.32|||Mixed Models Analysis|||Week 48, Role-Emotional: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.32|-1.61|0.4955
71814250|NCT03502616|143130725|SUPERIORITY||LS mean difference|0.65|STANDARD_ERROR_OF_MEAN|1.2||0.5888|TWO_SIDED|95.0|-1.71|3.01|||Mixed Models Analysis|||Week 48, Mental Health: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.01|-1.71|0.5888
71814251|NCT03502616|143130725|SUPERIORITY||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.896||0.115|TWO_SIDED|95.0|-0.35|3.18|||Mixed Models Analysis|||Week 48, Physical Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.18|-0.35|0.1150
71814252|NCT03502616|143130725|SUPERIORITY||LS mean difference|0.72|STANDARD_ERROR_OF_MEAN|1.158||0.5347|TWO_SIDED|95.0|-1.56|3.0|||Mixed Models Analysis|||Week 48, Mental Component Summary: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.00|-1.56|0.5347
71814253|NCT03502616|143130726|SUPERIORITY||LS mean difference|1.29|STANDARD_ERROR_OF_MEAN|0.898||0.1513|TWO_SIDED|95.0|-0.48|3.06|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.06|-0.48|0.1513
71814254|NCT03502616|143130726|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|1.02||0.1279|TWO_SIDED|95.0|-0.45|3.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.56|-0.45|0.1279
71814255|NCT03502616|143130726|SUPERIORITY||LS mean difference|3.83|STANDARD_ERROR_OF_MEAN|1.056||0.0003|TWO_SIDED|95.0|1.75|5.9|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.90|1.75|0.0003
71845712|NCT04172675|143206227|SUPERIORITY||Hazard Ratio (HR)|0.28|||=|0.0007|TWO_SIDED|95.0|0.13|0.61|||Unstratified Log rank||Hazard ratio and 95% CI were estimated using a Cox proportional hazards regression model.|||0.61|0.13|=0.0007
71845713|NCT03861052|143206249|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.27|-0.9|||Mixed Models Analysis|||||-0.90|-1.27|<0.001
71845714|NCT03861052|143206249|SUPERIORITY||Least Squares Mean Difference|-1.27|||<|0.001|TWO_SIDED|95.0|-1.45|-1.08|||Mixed Models Analysis|||||-1.08|-1.45|<0.001
71845715|NCT03861052|143206249|SUPERIORITY||Least Squares Mean Difference|-1.53|||<|0.001|TWO_SIDED|95.0|-1.71|-1.35|||Mixed Models Analysis|||||-1.35|-1.71|<0.001
71845716|NCT03861052|143206250|SUPERIORITY||Odds Ratio (OR)|9.89|||<|0.001|TWO_SIDED|95.0|4.53|21.55|||Regression, Logistic|||||21.55|4.53|<0.001
71896777|NCT01380093|143315739|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.86||||0.0065|TWO_SIDED|90.0|0.79|0.94|||Mixed Models Analysis|||Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||0.94|0.79|0.0065
71845717|NCT03861052|143206250|SUPERIORITY||Odds Ratio (OR)|20.57|||<|0.001|TWO_SIDED|95.0|7.73|54.71|||Regression, Logistic|||||54.71|7.73|<0.001
71845718|NCT03861052|143206250|SUPERIORITY||Odds Ratio (OR)|85.31|||<|0.001|TWO_SIDED|95.0|15.8|460.58|||Regression, Logistic|||||460.58|15.80|<0.001
71845719|NCT03861052|143206251|SUPERIORITY||Least Squares Mean Difference|-25.9|||<|0.001|TWO_SIDED|95.0|-30.7|-21.1|||Mixed Models Analysis|||||-21.1|-30.7|<0.001
71845720|NCT03861052|143206251|SUPERIORITY||Least Squares Mean Difference|-32.7|||<|0.001|TWO_SIDED|95.0|-37.5|-27.8|||Mixed Models Analysis|||||-27.8|-37.5|<0.001
71845721|NCT03861052|143206251|SUPERIORITY||Least Squares Mean Difference|-35.7|||<|0.001|TWO_SIDED|95.0|-40.6|30.9|||Mixed Models Analysis|||||30.9|-40.6|<0.001
71845722|NCT03861052|143206252|SUPERIORITY||Least Squares Mean Difference|-17.3|||<|0.001|TWO_SIDED|95.0|-21.4|-13.2|||ANCOVA|||||-13.2|-21.4|<0.001
71845723|NCT03861052|143206252|SUPERIORITY||Least Squares Mean Difference|-22.0|||<|0.001|TWO_SIDED|95.0|-26.1|-17.9|||ANCOVA|||||-17.9|-26.1|<0.001
71845724|NCT03861052|143206252|SUPERIORITY||Least Squares Mean Difference|-26.4|||<|0.001|TWO_SIDED|95.0|-30.5|-22.2|||ANCOVA|||||-22.2|-30.5|<0.001
71845725|NCT03861052|143206253|SUPERIORITY||Least Squares Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.4|-4.1|||Mixed Models Analysis|||||-4.1|-6.4|<0.001
71845726|NCT03861052|143206253|SUPERIORITY||Least Squares Mean Difference|-7.9|||<|0.001|TWO_SIDED|95.0|-9.1|-6.8|||Mixed Models Analysis|||||-6.8|-9.1|<0.001
71845727|NCT03861052|143206253|SUPERIORITY||Least Squares Mean Difference|-10.1|||<|0.001|TWO_SIDED|95.0|-11.3|-9.0|||Mixed Models Analysis|||||-9.0|-11.3|<0.001
71845728|NCT03861052|143206254|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.001|TWO_SIDED|95.0|7.88|26.46|||Regression, Logistic|||||26.46|7.88|<0.001
71845729|NCT03861052|143206254|SUPERIORITY||Odds Ratio (OR)|44.96|||<|0.001|TWO_SIDED|95.0|23.12|87.45|||Regression, Logistic|||||87.45|23.12|<0.001
71845730|NCT03861052|143206254|SUPERIORITY||Odds Ratio (OR)|82.67|||<|0.001|TWO_SIDED|95.0|39.84|171.52|||Regression, Logistic|||||171.52|39.84|<0.001
71845731|NCT03861052|143206255|SUPERIORITY||Least Squares Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.67|-1.28|||Mixed Models Analysis|||||-1.28|-3.67|<0.001
71845732|NCT03861052|143206255|SUPERIORITY||Least Squares Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|0.592|<|0.001|TWO_SIDED|95.0|-4.43|-2.11|||Mixed Models Analysis|||||-2.11|-4.43|<0.001
71845733|NCT03861052|143206255|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.587|<|0.001|TWO_SIDED|95.0|-4.55|-2.25|||Mixed Models Analysis|||||-2.25|-4.55|<0.001
71845734|NCT03861052|143206256|SUPERIORITY||Least Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.069|<|0.001|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|<0.001
71845735|NCT03861052|143206256|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.53|-0.27|||Mixed Models Analysis|||||-0.27|-0.53|<0.001
71845736|NCT03861052|143206256|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.067|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Models Analysis|||||-0.25|-0.51|<0.001
71845737|NCT03861052|143206257|SUPERIORITY||Least Squares Mean Difference|16.1|STANDARD_ERROR_OF_MEAN|2.72|<|0.001|TWO_SIDED|95.0|10.7|21.4|||Mixed Models Analysis|||||21.4|10.7|<0.001
71845738|NCT03861052|143206257|SUPERIORITY||Least Squares Mean Difference|20.6|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|14.9|26.3|||Mixed Models Analysis|||||26.3|14.9|<0.001
71845739|NCT03861052|143206257|SUPERIORITY||Least Squares Mean Difference|23.9|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|18.1|29.7|||Mixed Models Analysis|||||29.7|18.1|<0.001
71845740|NCT03861052|143206258|SUPERIORITY||Least Squares Mean Difference|19.9|STANDARD_ERROR_OF_MEAN|4.22|<|0.001|TWO_SIDED|95.0|11.7|28.2|||Mixed Models Analysis|||||28.2|11.7|<0.001
71845741|NCT03861052|143206258|SUPERIORITY||Least Squares Mean Difference|27.0|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|18.0|36.0|||Mixed Models Analysis|||||36.0|18.0|<0.001
71845742|NCT03861052|143206258|SUPERIORITY||Least Squares Mean Difference|31.2|STANDARD_ERROR_OF_MEAN|4.68|<|0.001|TWO_SIDED|95.0|22.0|40.4|||Mixed Models Analysis|||||40.4|22.0|<0.001
71845743|NCT03926026|143206277|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.0471|TWO_SIDED|95.0|-1.5|0.0|||t-test, 2 sided|||||0|-1.5|0.0471
71845744|NCT02824198|143206281|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (\>) 1/2 for each serotype.|Geometric mean of titer ratio|1.34|||||TWO_SIDED|95.0|0.998|1.79||||||Dengue Virus Serotype 1||1.79|0.998|
71677642|NCT05270395|142873697|SUPERIORITY||Odds Ratio (OR)|1.73||||0.42|TWO_SIDED|95.0|0.46|6.43|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||6.43|0.46|0.42
71677643|NCT05270395|142873698|SUPERIORITY||Odds Ratio (OR)|2.86||||0.08|TWO_SIDED|95.0|0.87|9.42|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||9.42|0.87|0.08
71677644|NCT05270395|142873699|SUPERIORITY||Odds Ratio (OR)|8.29||||0.004|TWO_SIDED|95.0|1.99|34.49|||Regression, Logistic|||We conducted logistic regression to predict knowledge of palliative care (as measured by ten items in the Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire) in the mPal intervention arm and in the standard of care arm at 1-month post-intervention, adjusting for baseline value of each item, age, and sex.||34.49|1.99|0.004
71677645|NCT01106677|142873711|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.758|-0.481|||ANCOVA|||||-0.481|-0.758|<0.001
71677646|NCT01106677|142873711|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.914|-0.636|||ANCOVA|||||-0.636|-0.914|<0.001
71677647|NCT01106677|142873711|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.795|-0.516||No formal statistical comparison was conducted.|ANCOVA|||||-0.516|-0.795|
71677648|NCT01106677|142873712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.001|TWO_SIDED|95.0|1.5|3.5|||Regression, Logistic|||||3.50|1.50|<0.001
71677649|NCT01106677|142873712|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.85|6.77|||Regression, Logistic|||||6.77|2.85|<0.001
71677650|NCT01106677|142873713|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.8|STANDARD_ERROR_OF_MEAN|3.044|<|0.001|TWO_SIDED|95.0|-35.76|-23.81|||ANCOVA|||||-23.81|-35.76|<0.001
71677651|NCT01106677|142873713|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-40.3|STANDARD_ERROR_OF_MEAN|3.055|<|0.001|TWO_SIDED|95.0|-46.25|-34.26|||ANCOVA|||||-34.26|-46.25|<0.001
71677652|NCT01106677|142873713|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.7|STANDARD_ERROR_OF_MEAN|3.06|||TWO_SIDED|95.0|-28.7|-16.69||No formal statistical comparison was conducted.|ANCOVA|||||-16.69|-28.70|
71896778|NCT01380093|143315740|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.98||||0.6399|TWO_SIDED|90.0|0.91|1.06|||Mixed Models Analysis|||Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.06|0.91|0.6399
71677653|NCT01106677|142873714|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-38.1|STANDARD_ERROR_OF_MEAN|5.601|<|0.001|TWO_SIDED|95.0|-49.14|-27.16|||ANCOVA|||||-27.16|-49.14|<0.001
71677654|NCT01106677|142873714|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|5.635|<|0.001|TWO_SIDED|95.0|-58.4|-36.29|||ANCOVA|||||-36.29|-58.40|<0.001
71677655|NCT01106677|142873714|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-39.6|STANDARD_ERROR_OF_MEAN|5.608|||TWO_SIDED|95.0|-50.56|-28.55||No formal statistical comparison was conducted.|ANCOVA|||||-28.55|-50.56|
71677656|NCT01106677|142873715|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.1|-1.9|||ANCOVA|||||-1.9|-3.1|<0.001
71677657|NCT01106677|142873715|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.5|-2.3|||ANCOVA|||||-2.3|-3.5|<0.001
71677658|NCT01106677|142873715|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.6||No formal statistical comparison was conducted.|ANCOVA|||||0.6|-0.6|
71677659|NCT01106677|142873716|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|0.979|<|0.001|TWO_SIDED|95.0|-7.28|-3.439|||ANCOVA|||||-3.439|-7.280|<0.001
71677660|NCT01106677|142873716|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|0.981|<|0.001|TWO_SIDED|95.0|-8.504|-4.653|||ANCOVA|||||-4.653|-8.504|<0.001
71677661|NCT01106677|142873716|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.34|STANDARD_ERROR_OF_MEAN|0.984|||TWO_SIDED|95.0|-5.273|-1.413||No formal statistical comparison was conducted.|ANCOVA|||||-1.413|-5.273|
71677662|NCT01106677|142873717|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|4.2||0.702||95.0|-9.9|6.7|||ANCOVA|||||6.7|-9.9|0.702
71677663|NCT01106677|142873717|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|4.3||0.274|TWO_SIDED|95.0|-13.0|3.7|||ANCOVA|||||3.7|-13.0|0.274
71677664|NCT01106677|142873717|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-10.6|6.1||No formal statistical comparison was conducted.|ANCOVA|||||6.1|-10.6|
71677665|NCT01106677|142873718|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.6|9.7|||ANCOVA|||||9.7|3.6|<0.001
71677666|NCT01106677|142873718|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|8.5|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|5.4|11.5|||ANCOVA|||||11.5|5.4|<0.001
71677667|NCT01106677|142873718|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-1.7|4.4||No formal statistical comparison was conducted.|ANCOVA|||||4.4|-1.7|
71688675|NCT02634983|142892844|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.87|STANDARD_ERROR_OF_MEAN|0.94||0.3624|TWO_SIDED|90.0|-0.73|2.48|||t-test, 2 sided|||Lung, Right Upper Lobe Perfusion||2.48|-0.73|0.3624
71677668|NCT01106677|142873719|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.061|||TWO_SIDED|95.0|-0.119|0.122|||ANCOVA|||||0.122|-0.119|
71677669|NCT01106677|142873719|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|-0.273|-0.031|||ANCOVA|||||-0.031|-0.273|
71814256|NCT03502616|143130726|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.282||0.0102|TWO_SIDED|95.0|0.79|5.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.84|0.79|0.0102
71814257|NCT03502616|143130726|SUPERIORITY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|1.285||0.0003|TWO_SIDED|95.0|2.2|7.26|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.26|2.20|0.0003
71814258|NCT03502616|143130726|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|1.439||0.895|TWO_SIDED|95.0|-2.64|3.02|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|-2.64|0.8950
71814259|NCT03502616|143130726|SUPERIORITY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|1.365||0.4732|TWO_SIDED|95.0|-3.67|1.71|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.71|-3.67|0.4732
71814260|NCT03502616|143130726|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.523||0.6359|TWO_SIDED|95.0|-3.72|2.28|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.28|-3.72|0.6359
71814261|NCT03502616|143130726|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.495||0.6894|TWO_SIDED|95.0|-3.54|2.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.35|-3.54|0.6894
71814262|NCT03502616|143130727|SUPERIORITY||LS mean difference|1.39|STANDARD_ERROR_OF_MEAN|0.94||0.141|TWO_SIDED|95.0|-0.46|3.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.24|-0.46|0.1410
71814263|NCT03502616|143130727|SUPERIORITY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|1.102||0.0122|TWO_SIDED|95.0|0.61|4.95|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.95|0.61|0.0122
71814264|NCT03502616|143130727|SUPERIORITY||LS mean difference|3.32|STANDARD_ERROR_OF_MEAN|1.252||0.0085|TWO_SIDED|95.0|0.86|5.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.79|0.86|0.0085
71814265|NCT03502616|143130727|SUPERIORITY||LS mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.416||0.0184|TWO_SIDED|95.0|0.57|6.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.15|0.57|0.0184
71814266|NCT03502616|143130727|SUPERIORITY||LS mean difference|4.19|STANDARD_ERROR_OF_MEAN|1.38||0.0026|TWO_SIDED|95.0|1.47|6.91|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.91|1.47|0.0026
71814267|NCT03502616|143130727|SUPERIORITY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|1.495||0.0236|TWO_SIDED|95.0|0.46|6.35|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.35|0.46|0.0236
71814268|NCT03502616|143130727|SUPERIORITY||LS mean difference|3.66|STANDARD_ERROR_OF_MEAN|1.541||0.0182|TWO_SIDED|95.0|0.63|6.7|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.70|0.63|0.0182
71845745|NCT02824198|143206281|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.603|||||TWO_SIDED|95.0|0.439|0.829||||||Dengue Virus Serotype 2||0.829|0.439|
71896779|NCT01380093|143315741|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.0||||0.9057|TWO_SIDED|90.0|0.94|1.08|||Mixed Models Analysis|||Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.08|0.94|0.9057
71896780|NCT01380093|143315742|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.03||||0.425|TWO_SIDED|90.0|0.97|1.1|||Mixed Models Analysis|||Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.10|0.97|0.4250
71896781|NCT01380093|143315743|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.1||||0.0204|TWO_SIDED|90.0|1.03|1.18|||Mixed Models Analysis|||Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.18|1.03|0.0204
71896782|NCT01380093|143315744|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.32||||0.0005|TWO_SIDED|90.0|1.17|1.49|||Mixed Models Analysis|||Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.||1.49|1.17|0.0005
71896783|NCT00234104|143315804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09||||0.0074||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0074
71896784|NCT00234104|143315804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0459||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0459
71896785|NCT00234104|143315804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32||||0.001||95.0|||||t-test, 2 sided|Dunnett's test was used||||||0.0010
71896786|NCT01088412|143315808|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.77|||||TWO_SIDED|95.0|2.24|5.96||||||Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.||5.96|2.24|
71896787|NCT01088412|143315809|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.71|||||TWO_SIDED|95.0|0.39|1.2||||||Epidemiological comparison between incidence of primary malignancies in study versus general population registry data, stratified by age and gender.||1.20|0.39|
71677670|NCT01106677|142873720|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|2.394|<|0.001|TWO_SIDED|95.0|-13.25|-3.857|||ANCOVA|||||-3.857|-13.25|<0.001
71814269|NCT03502616|143130727|SUPERIORITY||LS mean difference|3.85|STANDARD_ERROR_OF_MEAN|1.545||0.0133|TWO_SIDED|95.0|0.81|6.9|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.90|0.81|0.0133
71814270|NCT03502616|143130727|SUPERIORITY||LS mean difference|3.49|STANDARD_ERROR_OF_MEAN|1.541||0.0245|TWO_SIDED|95.0|0.45|6.52|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.52|0.45|0.0245
71677671|NCT01106677|142873720|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-17.5|STANDARD_ERROR_OF_MEAN|2.404|<|0.001|TWO_SIDED|95.0|-22.24|-12.81|||ANCOVA|||||-12.81|-22.24|<0.001
71896788|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.03|||||TWO_SIDED|95.0|2.14|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All DM (T1, T2 and DM Not Otherwise Specified \[NOS\] Combined)"||4.15|2.14|
71896789|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|2.74|||||TWO_SIDED|95.0|1.72|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)"||4.15|1.72|
71896790|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.91|||||TWO_SIDED|95.0|1.8|10.69||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined)"||10.69|1.80|
71896791|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.1|||||TWO_SIDED|95.0|0.84|7.93||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined)"||7.93|0.84|
71896792|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|11.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined)"||11.83|0.00|
71896793|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.36|10.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined)"||10.83|0.36|
71896794|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|4.55|||||TWO_SIDED|95.0|1.24|11.66||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined)"||11.66|1.24|
71896795|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|24.3||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined)"||24.30|0.00|
71896796|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.92|||||TWO_SIDED|95.0|0.56|1.44||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T1 DM."||1.44|0.56|
71896797|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.76|||||TWO_SIDED|95.0|0.36|1.4||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T1DM."||1.40|0.36|
71896798|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.5|||||TWO_SIDED|95.0|0.31|4.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T1DM."||4.38|0.31|
71896799|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|1.42|||||TWO_SIDED|95.0|0.29|4.14||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T1DM."||4.14|0.29|
71896800|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.23||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T1DM."||7.23|0.00|
71896801|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|3.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T1DM."||3.38|0.00|
71896802|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|2.09|||||TWO_SIDED|95.0|0.43|6.1||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T1DM."||6.10|0.43|
71896803|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio]|0.0|||||TWO_SIDED|95.0|0.0|14.84||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T1DM."||14.84|0.00|
71896804|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.79|||||TWO_SIDED|95.0|2.24|5.96||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T2 DM."||5.96|2.24|
71896805|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.93|||||TWO_SIDED|95.0|2.03|6.87||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T2DM."||6.87|2.03|
71896806|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|6.46|||||TWO_SIDED|95.0|1.33|18.89||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T2DM."||18.89|1.33|
71896807|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|7.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T2DM."||7.52|0.00|
71896808|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|31.16||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T2DM."||31.16|0.00|
71896809|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|7.9|||||TWO_SIDED|95.0|0.96|28.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T2DM."||28.52|0.96|
71896810|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|3.0|||||TWO_SIDED|95.0|0.08|16.7||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T2DM."||16.70|0.08|
71896811|NCT01088412|143315816|SUPERIORITY_OR_OTHER||Standardized Incidence Ratio|0.0|||||TWO_SIDED|95.0|0.0|63.97||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T2DM."||63.97|0.00|
71896812|NCT02708212|143315822|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.||||<0.0001
71677672|NCT01106677|142873721|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.0|-1.8|||ANCOVA|||||-1.8|-3.0|<0.001
71677673|NCT01106677|142873721|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-3.4|-2.3|||ANCOVA|||||-2.3|-3.4|<0.001
71677674|NCT01106677|142873722|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|0.812|<|0.001|TWO_SIDED|95.0|-4.464|-1.276|||ANCOVA|||||-1.276|-4.464|<0.001
71896813|NCT02708212|143315823|SUPERIORITY_OR_OTHER|||||||0.0012|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of midazolam between the two study groups.||||0.0012
71896814|NCT02708212|143315824|SUPERIORITY_OR_OTHER|||||||0.6967|||||||t-test, 2 sided|||||||0.6967
71896815|NCT05341466|143315825|SUPERIORITY||Mean Difference (Net)|0.528|STANDARD_ERROR_OF_MEAN|0.188||0.0098|||||||Mixed Models Analysis|||||||0.0098
71896816|NCT05341466|143315825|OTHER||Adjusted R-squared|0.418||||0.014|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step length asymmetry.||||0.014
71896817|NCT05341466|143315825|OTHER||Adjusted R-squared|0.496||||0.006|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus step time asymmetry.||||0.006
71896818|NCT05341466|143315825|OTHER||Adjusted R-squared|0.666||||0.001|||||||Regression, Linear|||Linear regression analyses performed with the change in the MEP amplitude versus changes in net metabolic power.||||0.001
71896819|NCT05341466|143315826|SUPERIORITY||Median Difference (Net)|-0.0042|STANDARD_DEVIATION|0.0232||0.744|||||||ANOVA|||||||0.744
71896820|NCT05341466|143315827|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_DEVIATION|0.0231||0.269|||||||ANOVA|||||||0.269
71896821|NCT05341466|143315828|SUPERIORITY||Median Difference (Net)|-0.4|STANDARD_DEVIATION|0.681||0.02|||||||ANOVA|||||||0.020
71896822|NCT01065428|143315841|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71896823|NCT01065428|143315842|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71922602|NCT03370133|143365467|SUPERIORITY||Odds Ratio (OR)|25.59|||<|0.001|TWO_SIDED|95.0|9.063|72.253||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||72.253|9.063|<0.001
71896824|NCT00196937|143315845|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.97|2.29||||||Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.29|-1.97|
71896825|NCT00196937|143315845|NON_INFERIORITY|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference \[Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group\] was below 10%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.87|2.03||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.||2.03|-1.87|
71896826|NCT01462292|143315859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.946||||0.554|TWO_SIDED|95.0|-39.122|21.229||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilizing a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg||21.229|-39.122|0.554
71896827|NCT01462292|143315859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.099||||0.069|TWO_SIDED|95.0|-2.21|56.408||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilising a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg||56.408|-2.210|0.069
71814271|NCT03502616|143130728|SUPERIORITY||LS mean difference|0.81|STANDARD_ERROR_OF_MEAN|0.257||0.0018|TWO_SIDED|95.0|0.3|1.32|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.32|0.30|0.0018
71814272|NCT03502616|143130728|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.301||0.0005|TWO_SIDED|95.0|0.47|1.65|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.47|0.0005
71814273|NCT03502616|143130728|SUPERIORITY||LS mean difference|1.19|STANDARD_ERROR_OF_MEAN|0.305||0.0001|TWO_SIDED|95.0|0.59|1.79|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.79|0.59|0.0001
71814274|NCT03502616|143130728|SUPERIORITY||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|1.09|2.17|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.17|1.09|<0.0001
71814275|NCT03502616|143130728|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.344|<|0.0001|TWO_SIDED|95.0|1.2|2.55|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.55|1.20|<0.0001
71814276|NCT03502616|143130728|SUPERIORITY||LS mean difference|0.95|STANDARD_ERROR_OF_MEAN|0.353||0.0075|TWO_SIDED|95.0|0.26|1.65|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.65|0.26|0.0075
71814277|NCT03502616|143130728|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.403||0.1489|TWO_SIDED|95.0|-0.21|1.38|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.21|0.1489
71814278|NCT03502616|143130728|SUPERIORITY||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.417||0.0609|TWO_SIDED|95.0|-0.04|1.61|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.61|-0.04|0.0609
71677675|NCT01106677|142873722|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.99|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.589|-2.389|||ANCOVA|||||-2.389|-5.589|<0.001
71814279|NCT03502616|143130728|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.429||0.4822|TWO_SIDED|95.0|-0.54|1.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.15|-0.54|0.4822
71814280|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.131||0.0047|TWO_SIDED|95.0|0.12|0.63|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.63|0.12|0.0047
71814281|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.131||0.0001|TWO_SIDED|95.0|0.26|0.77|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.77|0.26|0.0001
71814282|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.148||0.0012|TWO_SIDED|95.0|0.19|0.78|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.78|0.19|0.0012
71814283|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.142||0.0008|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|0.20|0.0008
71814284|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.147||0.0004|TWO_SIDED|95.0|0.24|0.81|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.81|0.24|0.0004
71814285|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.188||0.0918|TWO_SIDED|95.0|-0.05|0.69|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.69|-0.05|0.0918
71814286|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.179||0.16|TWO_SIDED|95.0|-0.1|0.61|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.61|-0.10|0.1600
71814287|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.195||0.6776|TWO_SIDED|95.0|-0.3|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.30|0.6776
71814288|NCT03502616|143130729|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5646|TWO_SIDED|95.0|-0.25|0.46|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.46|-0.25|0.5646
71814289|NCT03502616|143130730|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.161||0.7291|TWO_SIDED|95.0|-0.26|0.37|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.37|-0.26|0.7291
71814290|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.184||0.0257|TWO_SIDED|95.0|-0.78|-0.05|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.78|0.0257
71814291|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.227||0.0002|TWO_SIDED|95.0|-1.31|-0.42|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.31|0.0002
71845746|NCT02824198|143206281|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|0.979|||||TWO_SIDED|95.0|0.746|1.28||||||Dengue Virus Serotype 3||1.28|0.746|
71845747|NCT02824198|143206281|NON_INFERIORITY|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was \> 1/2 for each serotype.|Geometric mean of titer ratio|1.27|||||TWO_SIDED|95.0|0.918|1.75||||||Dengue Virus Serotype 4||1.75|0.918|
71845748|NCT01613417|143206294|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||0.8516|TWO_SIDED|95.0|-4.6|5.6||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||5.6|-4.6|0.8516
71677676|NCT01106677|142873723|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|3.2||0.466|TWO_SIDED|95.0|-3.9|8.5|||ANCOVA|||||8.5|-3.9|0.466
71677677|NCT01106677|142873723|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|3.2||0.323|TWO_SIDED|95.0|-3.1|9.4|||ANCOVA|||||9.4|-3.1|0.323
71814292|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.05|-0.2|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.05|0.0041
71814293|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.215||0.0062|TWO_SIDED|95.0|-1.02|-0.17|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.17|-1.02|0.0062
71896828|NCT01462292|143315860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.387||||0.699|TWO_SIDED|95.0|-1.618|2.392||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||2.392|-1.618|0.699
71896829|NCT01462292|143315860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.831||||0.384|TWO_SIDED|95.0|-1.072|2.735||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.735|-1.072|0.384
71896830|NCT01462292|143315861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.997|TWO_SIDED|95.0|-0.883|0.886||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment,centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Ascent Week 24||0.886|-0.883|0.997
71896831|NCT01462292|143315861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.803||||0.064|TWO_SIDED|95.0|-1.655|0.048||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Ascent, Week 24||0.048|-1.655|0.064
71896832|NCT01462292|143315861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.685||||0.311|TWO_SIDED|95.0|-2.033|0.662||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Descent Week 24||0.662|-2.033|0.311
71896833|NCT01462292|143315861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.412||||0.523|TWO_SIDED|95.0|-1.702|0.878||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Descent Week 24||0.878|-1.702|0.523
71896834|NCT01462292|143315862|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.564||||0.05|TWO_SIDED|95.0|0.0|1.127||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.127|0.000|0.050
71896835|NCT01462292|143315862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.037||||0.89|TWO_SIDED|95.0|-0.498|0.571||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||0.571|-0.498|0.890
71896836|NCT01462292|143315863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.356||||0.723|TWO_SIDED|95.0|-10.936|15.648||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 3 mg||15.648|-10.936|0.723
71896837|NCT01462292|143315863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821||||0.898|TWO_SIDED|95.0|-12.034|13.676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 6mg||13.676|-12.034|0.898
71677678|NCT01106677|142873724|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|2.5|8.0|||ANCOVA|||||8.0|2.5|<0.001
71677679|NCT01106677|142873724|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|7.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|4.5|10.1|||ANCOVA|||||10.1|4.5|<0.001
71677680|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Asiatic acid||||0.01
71677681|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Caffeic acid||||0.23
71814294|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.255||0.014|TWO_SIDED|95.0|-1.13|-0.13|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.13|-1.13|0.0140
71896838|NCT01462292|143315865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.684|TWO_SIDED|95.0|-2.9|1.92||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg||1.92|-2.90|0.684
71677682|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.001||||||Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Dihydrocaffeic acid||||0.001
71677683|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Dihydroferulic acid||||0.05
71896839|NCT01462292|143315865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.873|TWO_SIDED|95.0|-2.49|2.12||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg||2.12|-2.49|0.873
71677684|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.07|||||||t-test, 2 sided|||Ferulic acid||||0.07
71814295|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.225||0.0035|TWO_SIDED|95.0|-1.11|-0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.22|-1.11|0.0035
71814296|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.253||0.0645|TWO_SIDED|95.0|-0.97|0.03|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.97|0.0645
71814297|NCT03502616|143130730|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.255||0.0341|TWO_SIDED|95.0|-1.05|-0.04|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.05|0.0341
71814298|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.056||0.0001|TWO_SIDED|95.0|-0.33|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.33|0.0001
71814299|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-0.47|<0.0001
71814300|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.61|-0.31|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.31|-0.61|<0.0001
71814301|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.62|-0.32|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.32|-0.62|<0.0001
71814302|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.67|-0.37|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.37|-0.67|<0.0001
71814303|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.086||0.0008|TWO_SIDED|95.0|-0.46|-0.12|||LS mean difference|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.12|-0.46|0.0008
71814304|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.086||0.0116|TWO_SIDED|95.0|-0.39|-0.05|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.05|-0.39|0.0116
71814305|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.093||0.0416|TWO_SIDED|95.0|-0.37|-0.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-0.37|0.0416
71814306|NCT03502616|143130731|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.092||0.0915|TWO_SIDED|95.0|-0.34|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-0.34|0.0915
71814307|NCT03502616|143130732|SUPERIORITY||LS mean difference|2.85|STANDARD_ERROR_OF_MEAN|0.706|<|0.0001|TWO_SIDED|95.0|1.46|4.24|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.24|1.46|<0.0001
71677685|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.09
71677686|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.003|||||||t-test, 2 sided|||Isoferulic acid||||0.003
71677687|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Madecassic acid||||0.10
71677688|NCT03937908|142873725|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.11|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.11
71677689|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.82|||||||t-test, 2 sided|||Asiatic acid||||0.82
71677690|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Caffeic acid||||0.40
71677691|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.20
71677692|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.48|||||||t-test, 2 sided|||Dihydroferulic acid||||0.48
71677693|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.2|||||||t-test, 2 sided|||Ferulic acid||||0.20
71677694|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.32|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.32
71677695|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.35|||||||t-test, 2 sided|||Isoferulic acid||||0.35
71677696|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.52|||||||t-test, 2 sided|||Madecassic acid||||0.52
71814308|NCT03502616|143130732|SUPERIORITY||LS mean difference|3.61|STANDARD_ERROR_OF_MEAN|0.761|<|0.0001|TWO_SIDED|95.0|2.11|5.1|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.10|2.11|<0.0001
71814309|NCT03502616|143130732|SUPERIORITY||LS mean difference|5.42|STANDARD_ERROR_OF_MEAN|0.902|<|0.0001|TWO_SIDED|95.0|3.65|7.2|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.20|3.65|<0.0001
71814310|NCT03502616|143130732|SUPERIORITY||LS mean difference|5.01|STANDARD_ERROR_OF_MEAN|0.943|<|0.0001|TWO_SIDED|95.0|3.15|6.86|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||6.86|3.15|<0.0001
71814311|NCT03502616|143130732|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.012||0.0008|TWO_SIDED|95.0|1.44|5.42|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||5.42|1.44|0.0008
71814312|NCT03502616|143130732|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|1.064||0.139|TWO_SIDED|95.0|-0.52|3.68|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.68|-0.52|0.1390
71814313|NCT03502616|143130732|SUPERIORITY||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|1.024||0.5217|TWO_SIDED|95.0|-1.36|2.67|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.67|-1.36|0.5217
71882243|NCT02831673|143283286|OTHER||Mean Difference (Net)|-1.7|||||TWO_SIDED|95.0|-106.3|103.0|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||103.0|-106.3|
71882244|NCT02831673|143283286|OTHER||Median Difference (Net)|-32.6|||||TWO_SIDED|95.0|-132.2|66.9|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||66.9|-132.2|
71882245|NCT02831673|143283286|OTHER||Mean Difference (Net)|26.1|||||TWO_SIDED|95.0|-77.3|129.5|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||129.5|-77.3|
71814314|NCT03502616|143130732|SUPERIORITY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|1.027||0.1415|TWO_SIDED|95.0|-0.51|3.54|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.54|-0.51|0.1415
71814315|NCT03502616|143130732|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|1.128||0.0533|TWO_SIDED|95.0|-0.03|4.41|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.41|-0.03|0.0533
71814316|NCT03502616|143130733|SUPERIORITY||LS mean difference|1.25|STANDARD_ERROR_OF_MEAN|0.352||0.0005|TWO_SIDED|95.0|0.55|1.94|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.94|0.55|0.0005
71814317|NCT03502616|143130733|SUPERIORITY||LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|0.381|<|0.0001|TWO_SIDED|95.0|0.95|2.45|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.95|<0.0001
71814318|NCT03502616|143130733|SUPERIORITY||LS mean difference|2.19|STANDARD_ERROR_OF_MEAN|0.423|<|0.0001|TWO_SIDED|95.0|1.35|3.02|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.02|1.35|<0.0001
71814319|NCT03502616|143130733|SUPERIORITY||LS mean difference|1.98|STANDARD_ERROR_OF_MEAN|0.439|<|0.0001|TWO_SIDED|95.0|1.11|2.84|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.11|<0.0001
71845749|NCT01613417|143206294|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.0||||1|TWO_SIDED|95.0|-3.8|3.8||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||3.8|-3.8|1.0
71845750|NCT01613417|143206294|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||1|TWO_SIDED|95.0|-0.5|1.5||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)|||1.5|-0.5|1.0
71845751|NCT01613417|143206295|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845752|NCT01613417|143206295|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845753|NCT01613417|143206295|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845754|NCT01613417|143206296|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845755|NCT01613417|143206296|SUPERIORITY_OR_OTHER|||||||0.6875|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||0.6875
71845756|NCT01613417|143206296|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845757|NCT01613417|143206297|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845758|NCT01613417|143206297|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845759|NCT01613417|143206297|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845760|NCT01613417|143206298|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845761|NCT01613417|143206298|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845762|NCT01613417|143206298|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)|||||||1.0
71845763|NCT01613417|143206299|SUPERIORITY_OR_OTHER|||||||0.2758|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.2758
71845764|NCT01613417|143206299|SUPERIORITY_OR_OTHER|||||||0.0676|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.0676
71845765|NCT01613417|143206299|SUPERIORITY_OR_OTHER|||||||0.5267|TWO_SIDED||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect||||||0.5267
71845766|NCT01613417|143206300|SUPERIORITY_OR_OTHER|||||||0.6201|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.6201
71845767|NCT01613417|143206300|SUPERIORITY_OR_OTHER|||||||0.4514|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.4514
71845768|NCT01613417|143206300|SUPERIORITY_OR_OTHER|||||||0.7722|TWO_SIDED||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.||||||0.7722
71845769|NCT01613417|143206301|SUPERIORITY_OR_OTHER|||||||0.3173|TWO_SIDED||||||McNemar|||||||0.3173
71845770|NCT01613417|143206301|SUPERIORITY_OR_OTHER|||||||0.5637|TWO_SIDED||||||McNemar|||||||0.5637
71845771|NCT01613417|143206301|SUPERIORITY_OR_OTHER|||||||0.0455|TWO_SIDED||||||McNemar|||||||0.0455
71896840|NCT01462292|143315867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-892.88||||0.61|TWO_SIDED|95.0|-4391.1|2605.35||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 24||2605.35|-4391.10|0.610
71896841|NCT01462292|143315867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2054.86||||0.248|TWO_SIDED|95.0|-5587.33|1477.6||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 48||1477.60|-5587.33|0.248
71896842|NCT01462292|143315867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1305.46||||0.439|TWO_SIDED|95.0|-4668.41|2057.48||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 24||2057.48|-4668.41|0.439
71896843|NCT01462292|143315867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|167.39||||0.921|TWO_SIDED|95.0|-3208.98|3543.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 48||3543.77|-3208.98|0.921
71896844|NCT01462292|143315874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.541|TWO_SIDED|95.0|0.02|7.01||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 3 mg/kg/week||7.01|0.02|0.541
71896845|NCT01462292|143315874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.417|TWO_SIDED|95.0|0.03|4.27||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 6 mg/kg/week||4.27|0.03|0.417
71896846|NCT02973815|143315877|OTHER||Mean Difference (Final Values)|-0.062|STANDARD_ERROR_OF_MEAN|0.065||0.342|TWO_SIDED|95.0|-0.194|0.067|||Regression, Linear|||This was adjusted for the baseline BMI-Z score, child sex, baseline child age, and economic assistance||0.067|-0.194|0.342
71896847|NCT02973815|143315878|OTHER||Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.73104||0.09|TWO_SIDED|95.0|-0.2|2.71|||Regression, Linear|||Adjusted for: baseline HFI Fruit value, and economic assistance status||2.71|-0.20|0.09
71896848|NCT02973815|143315879|OTHER||Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|0.61||0.047|TWO_SIDED|95.0|0.02|2.44|||Regression, Linear|||Adjusted for: baseline HFI Vegetable value, and economic assistance status||2.44|0.02|0.047
71896849|NCT02973815|143315880|OTHER||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|0.08|0.88|||Regression, Linear|||Adjusted for: baseline healthfulness score and economic assistance status||0.88|0.08|0.019
71896850|NCT02973815|143315881|OTHER||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.12||0.218|TWO_SIDED|95.0|-0.4|0.09|||Regression, Linear|||Adjusted for: baseline vegetable intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.09|-0.4|0.218
71814320|NCT03502616|143130733|SUPERIORITY||LS mean difference|1.56|STANDARD_ERROR_OF_MEAN|0.454||0.0007|TWO_SIDED|95.0|0.67|2.45|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.45|0.67|0.0007
71896851|NCT02973815|143315882|OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.2||0.066|TWO_SIDED|95.0|-0.03|0.77|||Regression, Linear|||Adjusted for: baseline fruit intake, child age (baseline), parent education status (bachelors or higher vs lower)||0.77|-0.03|0.066
71896852|NCT02973815|143315883|OTHER||Mean Difference (Net)|-4.79|STANDARD_ERROR_OF_MEAN|4.41||0.28|TWO_SIDED|95.0|-13.56|3.98|||Regression, Linear|||Adjusted for: baseline MVPA, child age (baseline), and child sex||3.98|-13.56|0.28
71896853|NCT02973815|143315884|OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.928|TWO_SIDED|95.0|-0.31|0.34|||Regression, Linear|||Adjusted for: baseline screentime, child age (baseline), and child sex||0.34|-0.31|0.928
71896854|NCT02342561|143315890|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||At end of surgery||||0.601
71896855|NCT02342561|143315890|SUPERIORITY_OR_OTHER|||||||0.823|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||After skin disinfection||||0.823
71896856|NCT02342561|143315891|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Fisher Exact|||Difference in prevalence of CoNs between the 2 groups was analysed. The null-hypothesis was no difference.||||0.731
71896857|NCT01145391|143315897|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence||||||0.5||95.0||||For systolic blood pressure|Mixed Models Analysis|||||||0.50
71896858|NCT03037905|143315913|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.2|TWO_SIDED|95.0|-17.1|3.7|||Mixed Models Analysis|||||3.7|-17.1|0.20
71896859|NCT03037905|143315914|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.6|TWO_SIDED|95.0|-5.9|10.3|||Mixed Models Analysis|||||10.3|-5.9|0.60
71896860|NCT03037905|143315915|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.76|TWO_SIDED|95.0|-7.0|5.1|||Mixed Models Analysis|||||5.1|-7.0|.76
71896861|NCT03037905|143315916|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||.83
71896862|NCT01333189|143315937|SUPERIORITY_OR_OTHER||||||=|0.329|TWO_SIDED||||||Mixed Models Analysis|||||||=0.329
71896863|NCT01333189|143315938|SUPERIORITY_OR_OTHER||||||=|0.891|TWO_SIDED||||||Mixed Models Analysis|||||||=0.891
71896864|NCT01333189|143315939|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
71896865|NCT01333189|143315940|SUPERIORITY_OR_OTHER||||||=|0.509|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.509
71896866|NCT01333189|143315940|SUPERIORITY_OR_OTHER||||||=|0.5|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.500
71896867|NCT01333189|143315940|SUPERIORITY_OR_OTHER||||||=|0.607|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.607
71896868|NCT01333189|143315941|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
71896869|NCT01333189|143315942|SUPERIORITY_OR_OTHER||||||=|0.48|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.480
71896870|NCT01333189|143315942|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.120
71896871|NCT01333189|143315942|SUPERIORITY_OR_OTHER||||||=|0.668|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.668
71896872|NCT01333189|143315943|SUPERIORITY_OR_OTHER||||||=|0.511|TWO_SIDED||||||Mixed Models Analysis|||||||=0.511
71896873|NCT01333189|143315944|SUPERIORITY_OR_OTHER||||||=|0.402|TWO_SIDED||||||Mixed Models Analysis|||||||=0.402
71896874|NCT01333189|143315945|SUPERIORITY_OR_OTHER||||||=|0.021|TWO_SIDED||||||Mixed Models Analysis|||||||=0.021
71896875|NCT01333189|143315946|SUPERIORITY_OR_OTHER||||||=|0.686|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.686
71896876|NCT01333189|143315946|SUPERIORITY_OR_OTHER||||||=|0.434|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.434
71896877|NCT01333189|143315946|SUPERIORITY_OR_OTHER||||||=|0.227|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.227
71896878|NCT01333189|143315947|SUPERIORITY_OR_OTHER||||||=|0.068|TWO_SIDED||||||Mixed Models Analysis|||||||=0.068
71896879|NCT01333189|143315948|SUPERIORITY_OR_OTHER||||||=|0.16|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the hip||||=0.160
71896880|NCT01333189|143315948|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the knee||||=0.008
71896881|NCT01333189|143315948|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Mixed Models Analysis|||Internal moment at the ankle||||=0.877
71896882|NCT02218203|143315950|OTHER|We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.|Lidocaine dose*dextromethorphan dose|0.0042|STANDARD_ERROR_OF_MEAN|0.002||0.0322|TWO_SIDED|95.0|0.0004|0.0081|||Pearson's Chi-squared test||The estimated value is an estimated interaction term, and not a P-value.|We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).||0.0081|0.0004|0.0322
71896883|NCT00465738|143315951|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% Newcombe-Wilson confidence interval for the difference between the response rates of the groups was calculated. The lower bound of the Newcombe-Wilson CI for the difference of proportions was compared to the non-inferiority margin of -25%.|difference in response rates|10.6|||||TWO_SIDED|95.0|-4.4|24.9|||||difference in response rates = response rate for high volume dilution group (20 U/ml) - response rate for low volume dilution group (50 U/ml)|Null hypothesis: The response rate for the low volume dilution group (50 U/ml) is greater than the response rate for the high volume dilution group (20 U/ml).||24.9|-4.4|
71896884|NCT03461965|143316007|OTHER|p-value \< 0.05 was considered statistically significant||||||0.007|||||||t-test, 2 sided|||Comparing total responses that were correct across all participants in both arms||||0.007
71896885|NCT03461965|143316008|OTHER|p-value \< 0.05 was considered statistically significant||||||0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.0001
71896886|NCT03461965|143316008|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.03
71896887|NCT03461965|143316008|OTHER|p-value \< 0.05 was considered statistically significant||||||0.352|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.352
71896888|NCT03461965|143316009|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
71896889|NCT03461965|143316009|OTHER|p-value \< 0.05 was considered statistically significant||||||0.04|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||0.04
71896890|NCT03461965|143316009|OTHER|p-value \< 0.05 was considered statistically significant||||||0.052|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.052
71896891|NCT03461965|143316010|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
71896892|NCT03461965|143316010|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.0001|||||||t-test, 2 sided|||Difference of pre (baseline) and post-test scores within each treatment group||||<0.0001
71896893|NCT03461965|143316010|OTHER|p-value \< 0.05 was considered statistically significant||||||0.208|||||||t-test, 2 sided|paired t-test||Comparing change in scores (post-stage minus baseline) between experimental and control groups||||0.208
71896894|NCT03461965|143316011|OTHER|p-value \< 0.05 was considered statistically significant|||||<|0.03|||||||Chi-squared|||||||<0.03
71896895|NCT01863758|143316017|SUPERIORITY_OR_OTHER||Annualized number of bleeding episodes|3.13|||<|0.05|TWO_SIDED|95.0|2.56|3.8|||2-sided, 1-sample Poisson test||The annualized number of bleeding episodes in study GENA-01 was 49.36.|This study was considered as showing efficacy if the annualized number of bleeding episodes (BE) was reduced by 50% compared to the number of BEs observed in study GENA-01 (NCT00989196).||3.80|2.56|<0.05
71896896|NCT01863758|143316018|SUPERIORITY_OR_OTHER||Annualized number of spontaneous BEs|1.9|||<|0.05|TWO_SIDED|95.0|1.46|2.43|||2-sided, 1-sample Poisson test||The annualized number of spontaneous bleeding episodes in study GENA-01 was 32.23|This study was considered as showing efficacy if the annualized number of spontaneous bleeding episodes (BE) was reduced by 50% compared to the number of spontaneous BEs observed in study GENA-01 (NCT00989196).||2.43|1.46|<0.05
71896897|NCT00969618|143316089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for total ADHD symptoms score.|Paired t-test|||||||<0.001
71896898|NCT00969618|143316089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for inattention subscale score.|Paired t-test|||||||<0.001
71896899|NCT00969618|143316089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for hyperactivity/impulsivity subscale score.|Paired t-test|||||||<0.001
71896900|NCT00969618|143316089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for ADHD index subscale score.|Paired t-test|||||||<0.001
71896901|NCT00969618|143316090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71896902|NCT00969618|143316091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is GEC subscale score.|Paired t-test|||||||<0.001
71896903|NCT00969618|143316091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
71896904|NCT00969618|143316091|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
71896905|NCT00969618|143316092|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Paired t-test|||||||0.200
71896906|NCT00969618|143316093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|||||||<0.001
71896907|NCT00969618|143316094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GEC subscale score.|Paired t-test|||||||<0.001
71896908|NCT00969618|143316094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for behavioral regulation subscale score.|Paired t-test|||||||<0.001
71896909|NCT00969618|143316094|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for metacognition subscale score.|Paired t-test|||||||<0.001
71896910|NCT00969618|143316095|SUPERIORITY_OR_OTHER|||||||0.384||95.0|||||Paired t-test|||||||0.384
71896911|NCT05136885|143316096|SUPERIORITY||Disease Rate Ratio|0.87|STANDARD_DEVIATION|0.111|||TWO_SIDED|95.0|0.665|1.102||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. (Trehalose) slowed progression) was (0.8772). NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by Trehalose relative to placebo.Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, baseline use of Relyvrio, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, serum NfL concentration and random effects for regimen and participant-specific slopes.|1.102|0.665|
71896912|NCT05136885|143316098|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|1.79||0.7607|TWO_SIDED|95.0|-4.06|2.97|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||2.97|-4.06|0.7607
71896913|NCT05136885|143316099|SUPERIORITY||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|3.204||0.7737|TWO_SIDED|95.0|-5.37|7.21|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, pre-baseline ALSFRS-R slope, and baseline log-transformed NfL.|Trehalose 24-week change from baseline relative to placebo 24-week change from baseline.|||7.21|-5.37|0.7737
71896914|NCT05136885|143316100|SUPERIORITY|||||||0.2137|||||||Log Rank|||||||0.2137
71896915|NCT03165981|143316137|SUPERIORITY||Risk Ratio (RR)|0.87||||0.7588|TWO_SIDED|95.0|0.36|2.1|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.10|0.36|0.7588
71896916|NCT03165981|143316138|SUPERIORITY||Risk Ratio (RR)|0.97||||0.9412|TWO_SIDED|95.0|0.39|2.4|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.40|0.39|.9412
71896917|NCT03165981|143316139|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
71896918|NCT03165981|143316140|SUPERIORITY||Risk Ratio (RR)|0.87||||0.8325|TWO_SIDED|95.0|0.24|3.13|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||3.13|0.24|0.8325
71896919|NCT03165981|143316141|SUPERIORITY|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.||||||0.3408
71896920|NCT03165981|143316142|SUPERIORITY||Risk Ratio (RR)|0.73||||0.6101|TWO_SIDED|95.0|0.21|2.48|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.|||2.48|0.21|0.6101
71896921|NCT03165981|143316143|SUPERIORITY|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||||||0.848
71896922|NCT03165981|143316145|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71896923|NCT03270085|143316185|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71896924|NCT03270085|143316186|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71896925|NCT03270085|143316187|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71896926|NCT01269125|143316189|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|STANDARD_ERROR_OF_MEAN|0.0||0.8|TWO_SIDED|95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
71896927|NCT01269125|143316193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.05|STANDARD_ERROR_OF_MEAN|0.0||0.8||95.0|-0.2|0.3|||Chi-squared|||||0.3|-0.2|0.80
71896928|NCT01269125|143316193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.1|STANDARD_ERROR_OF_MEAN|0.0||0.48||95.0|-0.4|0.2|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.2|-0.4|0.48
71896929|NCT01269125|143316193|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-0.15|STANDARD_ERROR_OF_MEAN|0.0||0.22||95.0|-0.4|0.1|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.||0.1|-0.4|0.22
71896930|NCT02340104|143316194|EQUIVALENCE|Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.|Ratio of Geometric LS Means|0.789|||||TWO_SIDED|90.0|0.769|0.81|||||Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.|||0.810|0.769|
71896931|NCT02773758|143316226|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.509|-1.071|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.071|-1.509|<0.0001
71896932|NCT00663858|143316229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.592|STANDARD_ERROR_OF_MEAN|0.662||0.371|TWO_SIDED|95.0|-1.894|0.709|||ANOVA|||||0.709|-1.894|0.371
71677697|NCT03937908|142873726|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.13|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.13
71677698|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.34|||||||t-test, 2 sided|||Asiatic acid||||0.34
71677699|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.08
71677700|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Dihydroferulic acid||||0.23
71677701|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.14|||||||t-test, 2 sided|||Ferulic acid||||0.14
71677702|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.28|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.28
71677703|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.17|||||||t-test, 2 sided|||Isoferulic acid||||0.17
71677704|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.98|||||||t-test, 2 sided|||Madecassic acid||||0.98
71896933|NCT00663858|143316229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.711|STANDARD_ERROR_OF_MEAN|0.722||0.3253|TWO_SIDED|95.0|-709.0|2.132|||ANCOVA|||||2.132|-0709|0.3253
71677705|NCT03937908|142873727|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
71677706|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.04|||||||t-test, 2 sided|||Asiatic acid||||0.04
71677707|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.01|||||||t-test, 2 sided|||Caffeic acid||||0.01
71677708|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.06|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.06
71677709|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.08|||||||t-test, 2 sided|||Dihydroferulic acid||||0.08
71814321|NCT03502616|143130733|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.485||0.2018|TWO_SIDED|95.0|-0.33|1.58|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.58|-0.33|0.2018
71814322|NCT03502616|143130733|SUPERIORITY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.465||0.6432|TWO_SIDED|95.0|-0.7|1.13|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.13|-0.70|0.6432
71814323|NCT03502616|143130733|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.47||0.4092|TWO_SIDED|95.0|-0.54|1.31|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.31|-0.54|0.4092
71896934|NCT00663858|143316229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.324|STANDARD_ERROR_OF_MEAN|0.62||0.0333|TWO_SIDED|95.0|-2.542|-0.106|||ANCOVA|||||-0.106|-2.542|0.0333
71677710|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.56|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.56
71677711|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.21|||||||t-test, 2 sided|||Ferulic acid||||0.21
71677712|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.05
71677713|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.05|||||||t-test, 2 sided|||Isoferulic acid||||0.05
71677714|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.23|||||||t-test, 2 sided|||Madecassic acid||||0.23
71677715|NCT03937908|142873728|EQUIVALENCE|Two-sided paired t-tests were used to compare pharmacokinetic and clearance parameters between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.16|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.16
71896935|NCT03952546|143316283|NON_INFERIORITY|The test for non-inferiority was carried out by calculating the upper 95% confidence limit (one sided confidence interval) for the difference in estimated blood loss (δ = Unipolar electrocautery system - Saline-coupled bipolar sealer), with the margin of inferiority (δ), set at 200 cc.||||||0.1254|||||||t-test, 1 sided|||||||0.1254
71896936|NCT03952546|143316284|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71896937|NCT01371838|143316289|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was \>0% superioirty was concluded.|Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.||17.1|2.8|
71896938|NCT01371838|143316290|SUPERIORITY_OR_OTHER||Risk Difference (RD)|10.7|||||TWO_SIDED|95.0|4.9|16.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||16.4|4.9|
71896939|NCT01371838|143316291|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5|||||TWO_SIDED|95.0|1.8|15.4||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||15.4|1.8|
71677716|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.7|||||||t-test, 2 sided|||Asiatic acid||||0.7
71677717|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.09|||||||t-test, 2 sided|||Madecassic acid||||0.09
71896940|NCT01371838|143316292|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was \>0% superioirty was concluded in this population.|||19.2|6.8|
71896941|NCT01371838|143316293|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
71896942|NCT01371838|143316294|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
71896943|NCT01371838|143316297|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.2|||||TWO_SIDED|95.0|2.7|27.1||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||27.1|2.7|
71896944|NCT01371838|143316298|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.9|||||TWO_SIDED|95.0|-2.2|25.8||||RD is (Ceftaroline-Ceftriaxone) microbiologically favourable outcome rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||25.8|-2.2|
71896945|NCT01371838|143316299|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.0|||||TWO_SIDED|95.0|6.8|19.2||||RD is Ceftaroline minus Ceftriaxone overall success rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||19.2|6.8|
71896946|NCT01371838|143316300|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.9|||||TWO_SIDED|95.0|2.8|17.1||||RD is Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||17.1|2.8|
71896947|NCT01371838|143316301|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-2.5|3.0||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||3.0|-2.5|
71814324|NCT03502616|143130733|SUPERIORITY||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.506||0.107|TWO_SIDED|95.0|-0.18|1.81|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.81|-0.18|0.1070
71814325|NCT03502616|143130734|SUPERIORITY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|0.428||0.0002|TWO_SIDED|95.0|0.78|2.46|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.46|0.78|0.0002
71677718|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Asiaticoside||||0.4
71677719|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Madecassoside||||0.6
71677720|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Monocaffeoylquinic acids||||0.4
71845772|NCT01613417|143206302|SUPERIORITY_OR_OTHER|||||||0.6949|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.6949
71845773|NCT01613417|143206302|SUPERIORITY_OR_OTHER|||||||0.1317|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.1317
71845774|NCT01613417|143206302|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization||||0.0124
71845775|NCT00790699|143206317|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||RM-ANOVA|||The results were evaluated to determine if any statistically significant changes in any of these measures between the first and final visit occurred and if these changes were associated with membership in the treatment or control group.||||>.05
71845776|NCT01079806|143206318|SUPERIORITY||Difference estimate|20.2||||0.0049|TWO_SIDED|95.0|9.1|31.4|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||31.4|9.1|0.0049
71845777|NCT01079806|143206319|SUPERIORITY||Difference estimate|41.8|||<|0.0001|TWO_SIDED|95.0|29.4|54.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||54.2|29.4|<0.0001
71845778|NCT01079806|143206320|SUPERIORITY||Difference estimate|45.2|||<|0.0001||95.0|29.2|61.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||61.2|29.2|<0.0001
71845779|NCT01079806|143206321|SUPERIORITY||Difference estimate|38.2|||<|0.0001|TWO_SIDED|95.0|25.9|50.5|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||50.5|25.9|<0.0001
71845780|NCT01079806|143206322|SUPERIORITY||Difference estimate|12.1||||0.11|TWO_SIDED|95.0|-1.5|25.7|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.|||25.7|-1.5|0.11
71845781|NCT00734578|143206415|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.5||||0.002||95.0|-7.5|-1.4||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-1.4|-7.5|0.002
71845782|NCT00734578|143206415|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.3|||<|0.001||95.0|-8.3|-2.3||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.||-2.3|-8.3|<0.001
71845783|NCT00734578|143206416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.024
71845784|NCT00734578|143206416|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.003
71845785|NCT00734578|143206417|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.013
71896948|NCT01371838|143316302|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.4|4.5||||RD is Ceftaroline minus Ceftriaxone No-relapse rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|||4.5|-2.4|
71896949|NCT04315363|143316305|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the primary outcome changes (i.e., sedentary time) before and after the intervention.||||||0.8|||||||ANOVA|||||||0.8
71845786|NCT00734578|143206417|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
71845787|NCT00734578|143206418|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-1.7||||0.019||95.0|-3.2|-0.3||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.3|-3.2|0.019
71677721|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 2 sided|||Dicaffeoylquinic acids||||0.1
71845788|NCT00734578|143206418|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.6|||<|0.001||95.0|-4.0|-1.1||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.1|-4.0|<0.001
71845789|NCT00734578|143206419|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.002||95.0|-4.0|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-4.0|0.002
71845790|NCT00734578|143206419|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-3.0|||<|0.001||95.0|-4.5|-1.5||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.5|-4.5|<0.001
71845791|NCT00734578|143206420|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
71845792|NCT00734578|143206420|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||<0.001
71845793|NCT00734578|143206421|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.4||||0.001||95.0|-3.9|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.9|-3.9|0.001
71845794|NCT00734578|143206421|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-2.2||||0.003||95.0|-3.6|-0.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-0.7|-3.6|0.003
71896950|NCT04315363|143316306|EQUIVALENCE|Two by two Mixed Analysis of Variance (ANOVA) models (i.e., within-subject effect: pre- and post- intervention \* between-subject effect: intervention and control group) were estimated to investigate the secondary outcome changes (i.e., moderate-to-vigorous physical activity) before and after the intervention.||||||0.35|||||||ANOVA|||||||0.35
71896951|NCT01334125|143316307|SUPERIORITY_OR_OTHER|||||||0.903|TWO_SIDED|||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.903
71896952|NCT01334125|143316308|SUPERIORITY_OR_OTHER|||||||0.578|TWO_SIDED|95.0||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).||||0.578
71896953|NCT01334125|143316309|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANOVA|||Two way ANOVA comparison of the means of the adiponectin/leptin ratios between the metformin and placebo groups||||0.057
71896954|NCT01334125|143316310|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis for minor hypoglycemia||||1.00
71896955|NCT01334125|143316310|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||p value represents the analysis of the nocturnal hypoglycemia||||1.00
71896956|NCT00641043|143316315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.71|-0.3|||ANCOVA|||Linagliptin vs. Placebo||-0.30|-0.71|<0.0001
71677722|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||3-(3-hydroxyphenyl)propionic acid||||0.9
71845795|NCT00734578|143206422|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-5.1|||<|0.001||95.0|-8.0|-2.2||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-2.2|-8.0|<0.001
71845796|NCT00734578|143206422|SUPERIORITY_OR_OTHER_LEGACY||Placebo-adjusted difference in LS mean|-4.7||||0.002||95.0|-7.6|-1.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.||-1.7|-7.6|0.002
71845797|NCT00734578|143206423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.971||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.971
71845798|NCT00734578|143206423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.502||95.0||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.||||0.502
71896957|NCT00641043|143316316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.52|-0.24|||ANCOVA|||Linagliptin vs. Placebo||-0.24|-0.52|<0.0001
71896958|NCT00641043|143316317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.67|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.67|<0.0001
71677723|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.03|||||||t-test, 2 sided|||Caffeic acid||||0.03
71845799|NCT04652726|143206442|SUPERIORITY||LS Mean|-28.54|||<|0.0001|TWO_SIDED|95.0|-35.81|-21.27|||ANCOVA|||||-21.27|-35.81|<.0001
71845800|NCT04652726|143206443|SUPERIORITY||LS Mean|-29.3|||<|0.0001|TWO_SIDED|95.0|-36.24|-22.36|||MMRM|||||-22.36|-36.24|<.0001
71845801|NCT04652726|143206444|SUPERIORITY||LS Mean|-49.99|||<|0.0001|TWO_SIDED|95.0|-63.18|-36.81|||ANCOVA|||||-36.81|-63.18|<.0001
71845802|NCT04652726|143206445|SUPERIORITY||LS Mean|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.68|-19.73|||ANCOVA|||||-19.73|-31.68|<.0001
71845803|NCT04652726|143206446|SUPERIORITY||LS Mean|-6.18||||0.1419|TWO_SIDED|95.0|-17.48|5.12|||ANCOVA|||||5.12|-17.48|0.1419
71845804|NCT04652726|143206447|SUPERIORITY||LS Mean|-26.8|||<|0.0001|TWO_SIDED|95.0|-33.63|-19.97|||ANCOVA|||||-19.97|-33.63|<.0001
71896959|NCT00641043|143316318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.7|-0.32|||ANCOVA|||Linagliptin vs. Placebo||-0.32|-0.70|<0.0001
71896960|NCT00641043|143316319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001||95.0|-21.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-21.1|<0.0001
71896961|NCT00641043|143316320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001||95.0|-22.3|-10.5|||ANCOVA|||Linagliptin vs. Placebo||-10.5|-22.3|<0.0001
71896962|NCT00641043|143316321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001||95.0|-19.5|-7.0|||ANCOVA|||Linagliptin vs. Placebo||-7.0|-19.5|<0.0001
71896963|NCT00641043|143316322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-20.5|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-20.5|<0.0001
71896964|NCT00641043|143316323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.103||||0.0051||95.0|1.25|3.539|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||3.539|1.25|0.0051
71896965|NCT00641043|143316325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.348||||0.3547||95.0|0.716|2.537|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||2.537|0.716|0.3547
71845805|NCT04652726|143206448|SUPERIORITY||LS Mean|-19.2|||<|0.0001|TWO_SIDED|95.0|-24.65|-13.75|||ANCOVA|||||-13.75|-24.65|<.0001
71845806|NCT03274076|143206485|SUPERIORITY||Rate ratio|1.25|||||TWO_SIDED|90.0|0.19|8.33|||||Tofacitinib represents the numerator, and placebo represents the denominator.|H0: Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Tofacitinib.||8.33|0.19|
71896966|NCT00641043|143316327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.823|||<|0.0001||95.0|2.286|6.394|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||6.394|2.286|<0.0001
71896967|NCT03088605|143316376|SUPERIORITY||Mean Difference (Net)|-0.3||||0.02|TWO_SIDED|90.0|-0.7|0.0|||ANCOVA|||Change from Baseline. ANCOVA model includes baseline scores as a covariate||0|-0.7|0.02
71845807|NCT03274076|143206486|SUPERIORITY||Rate ratio|0.65|||||TWO_SIDED|90.0|0.25|1.71|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Tofacitinib||1.71|0.25|
71845808|NCT03274076|143206486|SUPERIORITY||Rate ratio|0.53|||||TWO_SIDED|90.0|0.26|1.07|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Tofacitinib||1.07|0.26|
71845809|NCT03274076|143206486|SUPERIORITY||Rate ratio|0.85|||||TWO_SIDED|90.0|0.49|1.49|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Tofacitinib||1.49|0.49|
71845810|NCT03274076|143206486|SUPERIORITY||Rate ratio|0.89|||||TWO_SIDED|90.0|0.52|1.52|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Tofacitinib||1.52|0.52|
71845811|NCT03274076|143206487|SUPERIORITY||Rate ratio|3.85|||||TWO_SIDED|90.0|0.68|21.77|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 36 in Placebo = Rate of adverse events of special interest throughout week 36 in Tofacitinib||21.77|0.68|
71845812|NCT03274076|143206487|SUPERIORITY||Rate ratio|1.87|||||TWO_SIDED|90.0|0.5169|6.7652|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 48 in Placebo = Rate of adverse events of special interest throughout week 48 in Tofacitinib||6.7652|0.5169|
71845813|NCT03274076|143206488|SUPERIORITY|||||||0.1978|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 12 in placebo = The absolute change in mRSS from week 0 to week 12 in Tofacitinib.||||0.1978
71845814|NCT03274076|143206488|SUPERIORITY|||||||0.4665|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 24 in placebo = The absolute change in mRSS from week 0 to week 24 in Tofacitinib.||||0.4665
71845815|NCT03274076|143206488|SUPERIORITY|||||||0.3063|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 36 in placebo = The absolute change in mRSS from week 0 to week 36 in Tofacitinib.||||0.3063
71845816|NCT03274076|143206488|SUPERIORITY|||||||0.6|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 48 in placebo = The absolute change in mRSS from week 0 to week 48 in Tofacitinib.||||0.6000
71845817|NCT03274076|143206489|SUPERIORITY|||||||0.4535|||||||Exact Wilcoxon|||H0: The CRISS score at week 12 in placebo = The CRISS score at week 12 in Tofacitinib.||||0.4535
71845818|NCT03274076|143206489|SUPERIORITY|||||||0.8392|||||||Exact Wilcoxon|||H0: The CRISS score at week 24 in placebo = The CRISS score at week 24 in Tofacitinib.||||0.8392
71845819|NCT03274076|143206489|SUPERIORITY|||||||0.9212|||||||Exact Wilcoxon|||H0: The CRISS score at week 48 in placebo = The CRISS score at week 48 in Tofacitinib.||||0.9212
71845820|NCT00975585|143206490|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|97.46|-0.058|0.031|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.||0.031|-0.058|
71845821|NCT00975585|143206491|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.25|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.005|||TWO_SIDED|97.46|-0.021|-0.01|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.||-0.010|-0.021|
71845822|NCT00975585|143206492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.402|STANDARD_ERROR_OF_MEAN|0.127|||TWO_SIDED|97.46|0.117|0.402|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.||0.402|0.117|
71845823|NCT00975585|143206493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|97.46|-0.218|0.098|||Mixed Models Analysis||The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.||0.098|-0.218|
71845824|NCT00975585|143206494|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|98.2|-0.123|-0.051|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.||-0.051|-0.123|
71845825|NCT00975585|143206495|NON_INFERIORITY_OR_EQUIVALENCE|Margin = 0.5|Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|98.2|-0.068|0.008|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.||0.008|-0.068|
71845826|NCT00975585|143206496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.411|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|98.2|-0.411|-0.117|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.||-0.117|-0.411|
71845827|NCT00683800|143206498|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.89|||<|0.001|TWO_SIDED|95.0|-3.8|-1.98|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.98|-3.80|<0.001
71845828|NCT00683800|143206499|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79|||<|0.001|TWO_SIDED|95.0|-3.77|-1.82|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-1.82|-3.77|<0.001
71845829|NCT00683800|143206500|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.4|-0.16|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.16|-0.40|<0.001
71845830|NCT00683800|143206501|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.44|-0.18|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).||-0.18|-0.44|<0.001
71845831|NCT00683800|143206502|SUPERIORITY_OR_OTHER||Wald Formula|-1.07|||||TWO_SIDED|90.0|-2.86|0.72|||||The 90% CI for excess risk was obtained using the Wald Formula.|Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||0.72|-2.86|
71896968|NCT03088605|143316377|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0001|TWO_SIDED|90.0|-1.4|0.5|||ANCOVA|||Change form baseline. ANCOVA model includes baseline score as a covariate.||0.5|-1.4|0.0001
71845832|NCT00683800|143206503|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.||||<0.001
71845833|NCT00683800|143206504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.47|||<|0.001|TWO_SIDED|95.0|2.24|5.36|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.36|2.24|<0.001
71845834|NCT00683800|143206504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.1|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||4.10|1.75|<0.001
71845835|NCT00683800|143206505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.39|||<|0.001|TWO_SIDED|95.0|2.47|7.81|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||7.81|2.47|<0.001
71845836|NCT00683800|143206505|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.96|5.09|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.||5.09|1.96|<0.001
71845837|NCT00683800|143206506|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||A log-rank test was used to compare the treatment groups.||||<0.001
71845838|NCT00683800|143206507|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-3.07|-1.0|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-1.00|-3.07|<0.001
71845839|NCT00683800|143206507|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.81|||<|0.001|TWO_SIDED|95.0|-4.12|-1.51|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-1.51|-4.12|<0.001
71845840|NCT00683800|143206508|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31||||0.002|TWO_SIDED|95.0|-0.51|-0.12|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)||-0.12|-0.51|0.002
71845841|NCT00683800|143206508|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33||||0.003|TWO_SIDED|95.0|-0.54|-0.11|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)||-0.11|-0.54|0.003
71845842|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.34|||<|0.001|TWO_SIDED|95.0|-3.05|-1.64|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.64|-3.05|<0.001
71845843|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.51|-0.99|<0.001
71896969|NCT03088605|143316378|SUPERIORITY||Mean Difference (Net)|-1.42||||0.03|TWO_SIDED|90.0|-2.36|-0.47|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||-0.47|-2.36|0.03
71896970|NCT03088605|143316379|SUPERIORITY||Mean Difference (Net)|0.199||||0.39|TWO_SIDED|90.0|-0.177|0.575|||ANCOVA|||Change from Baseline; ANCOVA model includes baseline score as a covariate.||0.575|-0.177|0.39
71896971|NCT03088605|143316380|SUPERIORITY||Mean Difference (Net)|0.2||||0.97|TWO_SIDED|90.0|-1.7|2.0|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||2.0|-1.7|0.97
71845844|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.45|-0.89|<0.001
71845845|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.05||||0.162|TWO_SIDED|95.0|-0.13|0.02|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.02|-0.13|0.162
71882246|NCT02831673|143283287|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-39.2|38.3|||||Baseline plasma HIV-1 RNA,\<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.|||38.3|-39.2|
71882247|NCT02831673|143283287|OTHER||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|-69.4|78.8|||||Baseline plasma HIV-1 RNA,\>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.|||78.8|-69.4|
71882248|NCT02831673|143283287|OTHER||Mean Difference (Net)|17.4|||||TWO_SIDED|95.0|-111.1|145.8|||||Baseline CD4+ cell count,\<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||145.8|-111.1|
71677724|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.9|||||||t-test, 2 sided|||Ferulic acid||||0.9
71814326|NCT03502616|143130734|SUPERIORITY||LS mean difference|1.92|STANDARD_ERROR_OF_MEAN|0.466|<|0.0001|TWO_SIDED|95.0|1.0|2.84|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.84|1.00|<0.0001
71814327|NCT03502616|143130734|SUPERIORITY||LS mean difference|3.26|STANDARD_ERROR_OF_MEAN|0.549|<|0.0001|TWO_SIDED|95.0|2.18|4.34|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.34|2.18|<0.0001
71814328|NCT03502616|143130734|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|1.93|4.15|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.15|1.93|<0.0001
71814329|NCT03502616|143130734|SUPERIORITY||LS mean difference|1.87|STANDARD_ERROR_OF_MEAN|0.621||0.0028|TWO_SIDED|95.0|0.65|3.09|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||3.09|0.65|0.0028
71814330|NCT03502616|143130734|SUPERIORITY||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.638||0.1289|TWO_SIDED|95.0|-0.28|2.23|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.23|-0.28|0.1289
71814331|NCT03502616|143130734|SUPERIORITY||LS mean difference|0.45|STANDARD_ERROR_OF_MEAN|0.616||0.4698|TWO_SIDED|95.0|-0.77|1.66|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.66|-0.77|0.4698
71814332|NCT03502616|143130734|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|0.603||0.0616|TWO_SIDED|95.0|-0.06|2.32|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.32|-0.06|0.0616
71814333|NCT03502616|143130734|SUPERIORITY||LS mean difference|1.37|STANDARD_ERROR_OF_MEAN|0.681||0.0455|TWO_SIDED|95.0|0.03|2.71|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.71|0.03|0.0455
71814334|NCT03502616|143130735|SUPERIORITY||LS mean difference|-0.88|STANDARD_ERROR_OF_MEAN|0.185|<|0.0001|TWO_SIDED|95.0|-1.25|-0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.52|-1.25|<0.0001
71814335|NCT03502616|143130735|SUPERIORITY||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.215|<|0.0001|TWO_SIDED|95.0|-1.65|-0.8|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.65|<0.0001
71677725|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.6|||||||t-test, 2 sided|||Isoferulic acid||||0.6
71814336|NCT03502616|143130735|SUPERIORITY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.232|<|0.0001|TWO_SIDED|95.0|-2.17|-1.26|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.26|-2.17|<0.0001
71814337|NCT03502616|143130735|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.247|<|0.0001|TWO_SIDED|95.0|-2.2|-1.23|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.23|-2.20|<0.0001
71814338|NCT03502616|143130735|SUPERIORITY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.07|-1.05|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.05|-2.07|<0.0001
71896972|NCT03088605|143316381|SUPERIORITY||Mean Difference (Net)|-0.23||||0.06|TWO_SIDED|90.0|-0.48|0.03|||ANCOVA|||Change from baseline. ANCOVA model includes baseline score as a covariate.||0.03|-0.48|0.06
71677726|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.4|||||||t-test, 2 sided|||Dihydroferulic acid||||0.4
71677727|NCT03937908|142873729|EQUIVALENCE|Two-sided paired t-tests were used to compare the ng/mL between the 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.8|||||||t-test, 2 sided|||Dihydrocaffeic acid||||0.8
71677728|NCT03937908|142873730|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||1 hour||||0.1
71896973|NCT03136705|143316393|SUPERIORITY||trend analysis|1.009||||0.3738|TWO_SIDED|95.0|0.989|1.031|||Mixed Models Analysis|||linear mixed model for repeated measures data||1.031|0.989|0.3738
71896974|NCT03136705|143316394|SUPERIORITY||trend analysis|0.0043||||0.854|TWO_SIDED|95.0|-0.0414|0.0499|||Mixed Models Analysis|||linear mixed model for repeated measures data||0.0499|-0.0414|0.854
71896975|NCT03136705|143316395|SUPERIORITY||trend analysis|20.38||||0.0648|TWO_SIDED|95.0|-1.26|42.03|||Mixed Models Analysis|||linear mixed model for repeated measures data||42.03|-1.26|0.0648
71896976|NCT04655586|143316398|SUPERIORITY|||||||0.4715||||||All rNAPc2 vs. Heparin|Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.4715
71677729|NCT03937908|142873730|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.1|||||||t-test, 1 sided|||2 hours||||0.1
71896977|NCT04655586|143316399|SUPERIORITY|||||||0.1883|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.1883
71896978|NCT04655586|143316402|SUPERIORITY|||||||1|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||1.0
71896979|NCT04655586|143316403|SUPERIORITY|||||||0.0254|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0254
71896980|NCT04655586|143316404|SUPERIORITY|||||||0.0535|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.0535
71677730|NCT03937908|142873730|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.3|||||||t-test, 1 sided|||3 hours||||0.3
71677731|NCT03937908|142873730|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||4 hours||||0.5
71677732|NCT03937908|142873730|EQUIVALENCE|Two-sided paired t-tests were used to compare fold induction between 2g and 4g doses. A p-value of less than 0.05 was considered statistically significant.||||||0.5|||||||t-test, 1 sided|||6 hours||||0.5
71814339|NCT03502616|143130735|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.281||0.0483|TWO_SIDED|95.0|-1.11|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.11|0.0483
71814340|NCT03502616|143130735|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.286||0.0357|TWO_SIDED|95.0|-1.17|-0.04|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.04|-1.17|0.0357
71677733|NCT03875092|142873731|OTHER||Hazard Ratio (HR)|0.35|||||TWO_SIDED|95.0|0.24|0.52|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.52|0.24|
71677734|NCT03875092|142873732|OTHER||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.28|0.7|||||Based on unstratified Cox regression model with treatment as a covariate, due to small sample size.|||0.70|0.28|
71677735|NCT03875092|142873733|OTHER||Difference in Percentage|36.7|||||TWO_SIDED|95.0|19.9|51.6|||||Based on unstratified Miettinen \& Nurminen method, due to small sample size.|||51.6|19.9|
71677736|NCT02163226|142873749|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
71896981|NCT04655586|143316405|SUPERIORITY|||||||0.83|||||||Wilcoxon Rank Sum|||All rNAPc2 doses (lower and higher) were pooled and compared to Heparin for statistical analysis presentation.||||0.8300
71896982|NCT00201201|143316409|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (1,161)=4.44,p=0.035).||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.||||0.035
71896983|NCT00201201|143316410|SUPERIORITY_OR_OTHER|||||||0.0204||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0204
71896984|NCT00201201|143316411|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||.0001
71896985|NCT00201201|143316412|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.||||0.0001
71896986|NCT00201201|143316413|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||t-test, 2 sided|||||||0.0431
71896987|NCT00201201|143316414|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||t-test, 2 sided|||Analyzed at 0 and 12 weeks.||||<.10
71896988|NCT01342640|143316419|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.||||<0.0001
71896989|NCT01342640|143316420|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.||||<.0001
71896990|NCT01342640|143316421|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.||||<.0001
71677737|NCT02163226|142873749|SUPERIORITY|||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
71677738|NCT02163226|142873749|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
71677739|NCT02163226|142873749|SUPERIORITY|||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
71677740|NCT02163226|142873749|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
71845846|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.42|||<|0.001|TWO_SIDED|95.0|-1.84|-1.0|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-1.84|<0.001
71845847|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.22||||0.066|TWO_SIDED|95.0|-0.46|0.01|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.46|0.066
71845848|NCT00683800|143206509|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.64|||<|0.001|TWO_SIDED|95.0|-0.79|-0.5|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.50|-0.79|<0.001
71845849|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.87|||<|0.001|TWO_SIDED|95.0|-2.57|-1.18|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.18|-2.57|<0.001
71845850|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.9|-0.41|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.41|-0.90|<0.001
71845851|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.58|||<|0.001|TWO_SIDED|95.0|-0.8|-0.37|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.37|-0.80|<0.001
71845852|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.04||||0.282|TWO_SIDED|95.0|-0.13|0.04|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.04|-0.13|0.282
71677741|NCT02163226|142873749|OTHER|2 sided p value||||||0.03|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 2 weeks||||.03
71677742|NCT02163226|142873749|OTHER|2 sided p value||||||0.19|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 1 month||||.19
71677743|NCT02163226|142873749|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 3 months||||.04
71677744|NCT02163226|142873749|OTHER|2 sided p value||||||0.89|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 6 months||||.89
71677745|NCT02163226|142873749|OTHER|2 sided p value||||||0.07|||||||Fisher Exact|||Pain Response Rates (CR+PR) at 9 months||||.07
71677746|NCT02163226|142873750|OTHER|2 sided p value||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
71677747|NCT02163226|142873750|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
71677748|NCT02163226|142873750|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
71677749|NCT02163226|142873750|OTHER|2 sided p valued||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
71677750|NCT02163226|142873750|OTHER|2 sided p valued||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
71677751|NCT02163226|142873750|OTHER|2 sided p valued||||||0.01|||||||Fisher Exact|||Pain response Rates (CR+PR) at 2 weeks||||.01
71677752|NCT02163226|142873750|OTHER|2 sided p value||||||0.15|||||||Fisher Exact|||Pain response Rates (CR+PR) at 1 month||||.15
71677753|NCT02163226|142873750|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 3 months||||.04
71677754|NCT02163226|142873750|OTHER|2 sided p value||||||0.78|||||||Fisher Exact|||Pain response Rates (CR+PR) at 6 months||||.78
71677755|NCT02163226|142873750|OTHER|2 sided p value||||||0.04|||||||Fisher Exact|||Pain response Rates (CR+PR) at 9 months||||.04
71677756|NCT01669174|142873890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|106.1|||<|0.001|TWO_SIDED|90.0|104.64|107.58|||ANCOVA|||Week 4||107.58|104.64|<0.001
71677757|NCT01669174|142873890|SUPERIORITY_OR_OTHER||Median Difference (Net)|107.75|||<|0.001|TWO_SIDED|90.0|106.18|109.35|||ANCOVA|||Week 8||109.35|106.18|<0.001
71882249|NCT02831673|143283287|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-37.2|34.1|||||Baseline CD4+ cell count,\>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.|||34.1|-37.2|
71882250|NCT02831673|143283287|OTHER||Mean Difference (Net)|-18.0|||||TWO_SIDED|95.0|-63.2|27.1|||||Age Group,\<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||27.1|-63.2|
71677758|NCT01669174|142873890|SUPERIORITY_OR_OTHER||Median Difference (Net)|108.63|||<|0.001|TWO_SIDED|90.0|106.31|111.0|||ANCOVA|||Week 16||111.00|106.31|<0.001
71677759|NCT01669174|142873890|SUPERIORITY_OR_OTHER||Median Difference (Net)|106.63|||<|0.001|TWO_SIDED|90.0|104.39|108.93|||ANCOVA|||Week 24||108.93|104.39|<0.001
71677760|NCT05537441|142873895|SUPERIORITY||Percent Difference|0.64||||0.216|TWO_SIDED||||||2 proportion Z-test|||||||0.216
71677761|NCT05537441|142873896|SUPERIORITY||Percent Difference|-0.61||||0.34|TWO_SIDED||||||2 proportion Z-test|||Previously vaccinated||||0.34
71677762|NCT05537441|142873896|SUPERIORITY||Percent Difference|-0.45||||0.247|TWO_SIDED||||||2 proportion Z-test|||Previously unvaccinated||||0.247
71677763|NCT01154296|142873897|SUPERIORITY_OR_OTHER||adjusted risk ratio (aRR)|1.12|||||TWO_SIDED|95.0|0.94|1.33||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).||1.33|0.94|
71677764|NCT01154296|142873898|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|0.99|||||TWO_SIDED|95.0|0.9|1.09|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.09|0.90|
71677765|NCT01154296|142873899|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.98|||||TWO_SIDED|95.0|0.86|1.13|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.13|0.86|
71677766|NCT01154296|142873900|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.88|||||TWO_SIDED|95.0|0.82|0.94|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||0.94|0.82|
71677767|NCT01154296|142873901|SUPERIORITY_OR_OTHER||Incidence Rate Ratio (IRR)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.||1.05|0.90|
71677768|NCT01154296|142873902|SUPERIORITY_OR_OTHER||Adjusted Risk Ratio (aRR)|1.14||||||95.0|0.89|1.46||In the statistical tests of all hypotheses and calculation of the presented risk ratios, we used multiple imputations of data sets with all 5012 cases. The aRRs reported are based on the multiply imputed data. Counts are based on the observed data.|Mantel Haenszel|||||1.46|0.89|
71677769|NCT02759055|142873917|SUPERIORITY||Risk Ratio (RR)|1.003|||<|0.05|TWO_SIDED|95.0|0.998|1.008|||Mixed Models Analysis|||||1.008|0.998|<0.05
71677770|NCT00614523|142873918|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.13|TWO_SIDED|95.0|0.66|1.05|||Anderson-Gill model|Anderson-Gill model using the model-based variance estimate and stratified by the randomization stratification factors|Romiplostim /Placebo|||1.05|0.66|0.13
71677771|NCT00614523|142873919|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.766|||<|0.001|TWO_SIDED|95.0|0.66|0.88|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.88|0.66|<0.001
71677772|NCT00614523|142873920|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.922||||0.026|TWO_SIDED|95.0|0.86|0.99|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo|||0.99|0.86|0.026
71677773|NCT00614523|142873921|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.739|||<|0.001|TWO_SIDED|95.0|0.68|0.8|||Poisson Regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.8|0.68|<0.001
71677774|NCT00614523|142873922|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.6|||<|0.001|TWO_SIDED|95.0|4.7|51.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for stratification factors.|Romiplostim /Placebo|||51.8|4.7|<0.001
71814341|NCT03502616|143130735|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.278||0.0508|TWO_SIDED|95.0|-1.09|0.0|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.00|-1.09|0.0508
71896991|NCT01745055|143316422|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|103.06|||||TWO_SIDED|90.0|99.0|107.29||||||Natural log transformed, AUC (0-12) of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.29|99.00|
71896992|NCT01745055|143316423|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|102.71|||||TWO_SIDED|90.0|93.79|112.47||||||Natural log transformed, Cmax of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||112.47|93.79|
71896993|NCT01745055|143316424|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|89.53|||||TWO_SIDED|90.0|77.38|103.57||||||Natural log transformed, AUClast of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||103.57|77.38|
71814342|NCT03502616|143130735|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.282||0.0614|TWO_SIDED|95.0|-1.08|0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.03|-1.08|0.0614
71896994|NCT01745055|143316425|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geometric Means|87.25|||||TWO_SIDED|90.0|76.03|100.12||||||Natural log transformed, Cmax of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.12|76.03|
71896995|NCT03237845|143316460|SUPERIORITY||Risk Difference (RD)|7.6||||0.0006|TWO_SIDED|95.0|3.3|11.9|||Cochran-Mantel-Haenszel|||||11.9|3.3|0.0006
71896996|NCT03237845|143316461|SUPERIORITY||Risk Difference (RD)|12.4|||<|0.0001|TWO_SIDED|95.0|6.9|17.9|||Cochran-Mantel-Haenszel|||||17.9|6.9|< 0.0001
71896997|NCT03237845|143316462|SUPERIORITY||Risk Difference (RD)|15.1|||<|0.0001|TWO_SIDED|95.0|9.4|20.8|||Cochran-Mantel-Haenszel|||||20.8|9.4|< 0.0001
71896998|NCT03237845|143316463|SUPERIORITY||Risk Difference (RD)|9.9||||0.0039|TWO_SIDED|95.0|3.2|16.6|||Cochran-Mantel-Haenszel|||||16.6|3.2|0.0039
71896999|NCT03237845|143316464|SUPERIORITY||Risk Difference (RD)|15.3|||<|0.0001|TWO_SIDED|95.0|9.4|21.2|||Cochran-Mantel-Haenszel|||||21.2|9.4|< 0.0001
71897000|NCT03237845|143316465|SUPERIORITY||Risk Difference (RD)|4.8||||0.2084|TWO_SIDED|95.0|-2.7|12.2||P-Value ≥ 0.05; therefore, all secondary outcome measures listed after this outcome measure in the hierarchy were not tested.|Cochran-Mantel-Haenszel|||||12.2|-2.7|0.2084
71897001|NCT03865407|143316479|SUPERIORITY|||||||0.1839|||||||t-test, 2 sided|||||||0.1839
71897002|NCT03865407|143316480|SUPERIORITY|||||||0.3036|||||||t-test, 2 sided|||||||0.3036
71897003|NCT03865407|143316481|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71897004|NCT03865407|143316482|SUPERIORITY|||||||0.1421|||||||t-test, 2 sided|||||||0.1421
71897005|NCT03865407|143316483|SUPERIORITY|||||||0.0022|||||||t-test, 2 sided|||||||0.0022
71897006|NCT03865407|143316484|SUPERIORITY|||||||0.3032|||||||t-test, 2 sided|||||||0.3032
71897007|NCT01645280|143316500|SUPERIORITY_OR_OTHER|||||||0.184|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.184
71897008|NCT01645280|143316500|SUPERIORITY_OR_OTHER|||||||0.13|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.130
71677775|NCT00614523|142873923|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.402||||0.032|TWO_SIDED|95.0|1.03|1.91|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||1.91|1.03|0.032
71897009|NCT01645280|143316500|SUPERIORITY_OR_OTHER|||||||0.642|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.642
71897010|NCT01645280|143316500|SUPERIORITY_OR_OTHER|||||||0.832|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.832
71897011|NCT01645280|143316501|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.019
71897012|NCT01645280|143316501|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.025
71897013|NCT01645280|143316501|SUPERIORITY_OR_OTHER|||||||0.248|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.248
71897014|NCT01645280|143316501|SUPERIORITY_OR_OTHER|||||||0.045|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.045
71897015|NCT01645280|143316502|SUPERIORITY_OR_OTHER|||||||0.381|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.381
71897016|NCT01645280|143316502|SUPERIORITY_OR_OTHER|||||||0.543|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.543
71897017|NCT01645280|143316502|SUPERIORITY_OR_OTHER|||||||0.629|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.629
71897018|NCT01645280|143316502|SUPERIORITY_OR_OTHER|||||||0.273|||||||Cochran-Mantel-Haenszel|Screening CRP level (\>= 1.50 mg/dL; \< 1.50 mg/dL) was used as stratification factors.||||||0.273
71897019|NCT01645280|143316503|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.060
71897020|NCT01645280|143316503|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.134
71897021|NCT01645280|143316503|SUPERIORITY_OR_OTHER|||||||0.28|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.280
71897022|NCT01645280|143316503|SUPERIORITY_OR_OTHER|||||||0.345|||||||ANCOVA|Treatment, screening CRP level (\>=1.50 mg/dL, \<1.50mg/dL) and baseline score as covariates.||||||0.345
71897023|NCT02052960|143316552|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.86|TWO_SIDED|95.0|0.736|1.359|||Log Rank|||||1.359|0.736|0.86
71897024|NCT02052960|143316553|SUPERIORITY||Mean Difference (Net)|-1.9||||0.77|TWO_SIDED|95.0|-14.5|10.7|||Chi-squared|||||10.7|-14.5|0.77
71897025|NCT02052960|143316554|SUPERIORITY||Mean Difference (Net)|-1.21||||0.83|TWO_SIDED|95.0|-12.05|9.63|||Chi-squared|||||9.63|-12.05|0.83
71897026|NCT02052960|143316555|SUPERIORITY||Hazard Ratio (HR)|1.057||||0.7|TWO_SIDED|95.0|0.814|1.372|||Log Rank|||||1.372|0.814|0.70
71897027|NCT02052960|143316556|SUPERIORITY||Hazard Ratio (HR)|1.012||||0.96|TWO_SIDED|95.0|0.734|1.396|||Log Rank|||||1.396|0.734|0.96
71897028|NCT03849560|143316558|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H1N1 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.22|||||TWO_SIDED|95.0|0.82|1.82||||||||1.82|0.82|
71897029|NCT03849560|143316558|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for antigen H3N2 in group Grippol® Quadri and groups Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.54|||||TWO_SIDED|95.0|1.08|2.3||||||||2.30|1.08|
71897030|NCT03849560|143316558|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for YAMA antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Yamagata lineage)|Odds Ratio, log|1.39|||||TWO_SIDED|95.0|0.9|2.15||||||||2.15|0.90|
71897031|NCT03849560|143316558|NON_INFERIORITY|Odds ratio was calculated to compare seroconversion for VICT antigen in group Grippol® Quadri and group Grippol® Plus, trivalent (Victoria lineage)|Odds Ratio, log|1.05|||||TWO_SIDED|95.0|0.68|1.63||||||||1.63|0.68|
71897032|NCT03849560|143316559|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H1N1 if the upper limit of the two-sided 95% Confidence Interval (CI) of the ratio of means of geometric antibody titers for H1N1 was ≤1.5|Mean Difference (Final Values)|0.8933|||||TWO_SIDED|95.0|0.7762|1.03||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H1N1||1.030|0.7762|
71897033|NCT03849560|143316559|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) vaccines for the strain A/H3N2 if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for H3N2 was ≤1.5|Median Difference (Final Values)|0.8913|||||TWO_SIDED|95.0|0.7516|1.0593||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) and Grippol® Plus, trivalent (Victoria lineage) for the strain A/H3N2||1.0593|0.7516|
71897034|NCT03849560|143316559|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Yamagata lineage) vaccine for the strain B/Yamagata if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Yamagata antigen was ≤1|Mean Difference (Final Values)|0.8185|||||TWO_SIDED|95.0|0.6918|0.9683||||||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Yamagata lineage) for the strain B/Yamagata||0.9683|0.6918|
71897035|NCT03849560|143316559|NON_INFERIORITY|The Grippol® Quadri vaccine considered non-inferior to Grippol® Plus, trivalent (Victoria lineage) vaccine for the strain B/Victoria if the upper limit of the two-sided 95% CI of the ratio of means of geometric antibody titers for Victoria antigen was ≤1|Mean Difference (Final Values)|1.0328||||0.05|TWO_SIDED|95.0|0.857|1.2445|||ANCOVA|||Non-inferiority of Grippol® Quadri over Grippol® Plus, trivalent (Victoria lineage) for the strain B/Victoria||1.2445|0.8570|0.05
71897036|NCT03849560|143316560|NON_INFERIORITY|Seroprotection for strain A/H1N1 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.758|||||||Fisher Exact|||||||0.758
71897037|NCT03849560|143316560|NON_INFERIORITY|Seroprotection for strain A/H3N2 in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage)+Grippol® Plus, trivalent (Victoria lineage) groups||||||0.282|||||||Fisher Exact|||||||0.282
71897038|NCT03849560|143316560|NON_INFERIORITY|Seroprotection for strain B/Yamagata in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Yamagata lineage) group||||||0.352|||||||Fisher Exact|||||||0.352
71897039|NCT03849560|143316560|NON_INFERIORITY|Seroprotection for strain B/Victoria in Grippol® Quadri group in comparison to Grippol® Plus, trivalent (Victoria lineage) group||||||0.815|||||||Fisher Exact|||||||0.815
71897040|NCT03849560|143316561|OTHER|||||||0.452|||||||Log Rank|||||||0.452
71897041|NCT03849560|143316561|OTHER|||||||0.639|||||||Log Rank|||||||0.639
71897042|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of mean geometri|4.86|||||TWO_SIDED|95.0|4.22|5.6||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Quadri group||5.60|4.22|
71897043|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.32|||||TWO_SIDED|95.0|4.53|6.24||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Quadri group||6.24|4.53|
71897044|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|5.47|||||TWO_SIDED|95.0|4.78|6.25||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Quadri group||6.25|4.78|
71897045|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.77|||||TWO_SIDED|95.0|4.14|5.49||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Quadri group||5.49|4.14|
71897046|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.21|||||TWO_SIDED|95.0|3.59|4.94||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Yamagata lineage) group||4.94|3.59|
71897047|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.22|||||TWO_SIDED|95.0|4.45|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Yamagata lineage) group||6.12|4.45|
71897048|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Yamagata should be ˃ 2.5|Coefficient of increase of GMT|4.04|||||TWO_SIDED|95.0|3.48|4.69||||||Coefficient of increase of mean geometric antibody titer for Yamagata in Grippol® Plus, trivalent (Yamagata lineage) group||4.69|3.48|
71897049|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H1N1 should be ˃ 2.5|Coefficient of increase of GMT|4.6|||||TWO_SIDED|95.0|3.97|5.34||||||Coefficient of increase of mean geometric antibody titer for H1N1 in Grippol® Plus, trivalent (Victoria lineage) group||5.34|3.97|
71897050|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for H3N2 should be ˃ 2.5|Coefficient of increase of GMT|5.17|||||TWO_SIDED|95.0|4.38|6.12||||||Coefficient of increase of mean geometric antibody titer for H3N2 in Grippol® Plus, trivalent (Victoria lineage) group||6.12|4.38|
71897051|NCT03849560|143316563|OTHER|The lower limit of the two-sided 95% CI (log 10) on coefficient of increase of mean geometric antibody titer for Victoria should be ˃ 2.5|Coefficient of increase of GMT|4.72|||||TWO_SIDED|95.0|4.0|5.56||||||Coefficient of increase of mean geometric antibody titer for Victoria in Grippol® Plus, trivalent (Victoria lineage) group||5.56|4.00|
71897052|NCT01678846|143316621|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.26|0.64|||Regression, Logistic||An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.|Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.||0.64|0.26|<0.0001
71897053|NCT01507545|143316630|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.7335|TWO_SIDED|95.0|0.76|1.67|||One-sided log-rank test|||||1.67|0.76|0.7335
71897054|NCT01507545|143316631|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.9498|TWO_SIDED|95.0|0.93|2.19|||One-sided log-rank test|||||2.19|0.93|0.9498
71897055|NCT01507545|143316632|SUPERIORITY||Difference of arms|-2.4||||0.333|TWO_SIDED|95.0|-6.992|2.23|||Fisher Exact|||||2.230|-6.992|0.333
71897056|NCT00553787|143316642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|0.328|<|0.0001|TWO_SIDED|95.0|7.96|9.25||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.25|7.96|<0.0001
71897057|NCT00553787|143316642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|0.403|<|0.0001|TWO_SIDED|95.0|5.79|7.37||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.37|5.79|<0.0001
71897058|NCT00553787|143316642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_ERROR_OF_MEAN|0.402|<|0.0001|TWO_SIDED|95.0|1.24|2.82||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||2.82|1.24|<0.0001
71897059|NCT00553787|143316643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.03|STANDARD_ERROR_OF_MEAN|0.955|<|0.0001|TWO_SIDED|95.0|7.34|11.11||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||11.11|7.34|<0.0001
71897060|NCT00553787|143316643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.27|STANDARD_ERROR_OF_MEAN|0.768|<|0.0001|TWO_SIDED|95.0|4.93|7.97||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||7.97|4.93|<0.0001
71897061|NCT00553787|143316643|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.169||0.0018|TWO_SIDED|95.0|1.15|1.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||1.81|1.15|0.0018
71897062|NCT02285010|143316644|NON_INFERIORITY|Definition: 50% reduction of morphine consumption Type I error (alpha) 0.05, Type II error (beta) 80%||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71897063|NCT02285010|143316645|NON_INFERIORITY|Alpha 0.05, Beta 80%||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.10
71897064|NCT02285010|143316646|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.33|||||||Wilcoxon (Mann-Whitney)|||for NRS at rest||||0.33
71897065|NCT02285010|143316646|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.75|||||||Wilcoxon (Mann-Whitney)|||for NRS at movement||||0.75
71897066|NCT02285010|143316647|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.16|||||||Chi-squared|||For pruritus||||0.16
71897067|NCT02285010|143316647|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.66|||||||Chi-squared|||For Nausea||||0.66
71897068|NCT02285010|143316647|NON_INFERIORITY|alpha 0.05, beta 80%||||||0.46|||||||Chi-squared|||For Vomiting||||0.46
71897069|NCT02285010|143316647|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.54|||||||Chi-squared|||For Dizziness||||0.54
71897070|NCT02285010|143316647|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05|||||||Chi-squared|||For visual disturbance||||0.05
71897071|NCT02285010|143316648|NON_INFERIORITY|Alpha 0.05, beta 80%||||||0.05||||||P-Value 0.05 was calculated.|Chi-squared|||||||0.05
71897072|NCT01426386|143316651|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|7.9|||<|0.001|TWO_SIDED|95.0|5.69|10.18||The a priori threshold for statistical significance was 5% (two-sided)|ANCOVA|Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||10.18|5.69|<0.001
71897073|NCT01426386|143316652|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|11.1|||<|0.001|TWO_SIDED|95.0|6.78|15.48||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||15.48|6.78|<0.001
71897074|NCT01426386|143316653|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|0.8|||<|0.001|TWO_SIDED|95.0|0.56|1.11||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||1.11|0.56|<0.001
71922603|NCT03370133|143365468|SUPERIORITY||Odds Ratio (OR)|25.471|||<|0.001|TWO_SIDED|95.0|9.02|71.925||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||71.925|9.020|<0.001
71897075|NCT01426386|143316655|OTHER|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|3.2|||<|0.001|TWO_SIDED|95.0|1.71|4.78||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model||4.78|1.71|<0.001
71897076|NCT01426386|143316657|OTHER|Treatment groups were compared using the chi-squared test.||||||0.248||||||No adjustment for multiplicity was applied for the secondary endpoints|Chi-squared|||||||0.248
71897077|NCT01096667|143316660|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.97||||0.034|TWO_SIDED|80.0|-5.05|-0.89||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.89|-5.05|0.034
71897078|NCT01096667|143316660|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.0||||0.01|TWO_SIDED|80.0|-6.17|-1.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.82|-6.17|0.010
71897079|NCT01096667|143316660|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.69||||0.012|TWO_SIDED|80.0|-5.78|-1.6||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.60|-5.78|0.012
71897080|NCT01096667|143316660|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.21||||0.024|TWO_SIDED|80.0|-5.3|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.13|-5.30|0.024
71897081|NCT01096667|143316662|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.7||||0.018|TWO_SIDED|80.0|-5.94|-1.46||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.46|-5.94|0.018
71897082|NCT01096667|143316662|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.43||||0.008|TWO_SIDED|80.0|-6.78|-2.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.09|-6.78|0.008
71897083|NCT01096667|143316662|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99||||0.002|TWO_SIDED|80.0|-7.24|-2.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-2.74|-7.24|0.002
71897084|NCT01096667|143316662|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.92||||0.013|TWO_SIDED|80.0|-6.16|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.67|-6.16|0.013
71897085|NCT01096667|143316663|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.152|TWO_SIDED|80.0|-4.93|0.54||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.54|-4.93|0.152
71897086|NCT01096667|143316663|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.18||||0.078|TWO_SIDED|80.0|-6.06|-0.3||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.30|-6.06|0.078
71897087|NCT01096667|143316663|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.02||||0.174|TWO_SIDED|80.0|-4.79|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.79|0.174
71897088|NCT01096667|143316663|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.01||||0.174|TWO_SIDED|80.0|-4.77|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.74|-4.77|0.174
71897089|NCT01096667|143316665|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.01||||0.047|TWO_SIDED|80.0|-7.09|-0.94||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-0.94|-7.09|0.047
71897090|NCT01096667|143316665|SUPERIORITY_OR_OTHER||Difference in least squares means|-7.16||||0.002|TWO_SIDED|80.0|-10.25|-4.07||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-4.07|-10.25|0.002
71897091|NCT01096667|143316665|SUPERIORITY_OR_OTHER||Difference in least squares means|-6.2||||0.005|TWO_SIDED|80.0|-9.28|-3.11||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-3.11|-9.28|0.005
71897092|NCT01096667|143316665|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.37||||0.033|TWO_SIDED|80.0|-7.41|-1.33||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.33|-7.41|0.033
71897093|NCT01096667|143316667|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.66||||0.007|TWO_SIDED|80.0|-4.03|-1.29||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.29|-4.03|0.007
71897094|NCT01096667|143316667|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.11||||0.003|TWO_SIDED|80.0|-4.55|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.67|-4.55|0.003
71897095|NCT01096667|143316667|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.27||||0.018|TWO_SIDED|80.0|-3.65|-0.88||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.88|-3.65|0.018
71677776|NCT00614523|142873927|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.639|||<|0.001|TWO_SIDED|95.0|0.57|0.71|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo|||0.71|0.57|<0.001
71677777|NCT02877095|142873928|OTHER|||||||||||||||||All subjects on study received active drug.|Total count of events is provided.|||
71677778|NCT03692325|142873983|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71677779|NCT00425061|142873991|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-5.2||||0.612|TWO_SIDED|95.0|-25.6|15.2|||ANCOVA|||Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid \[ICS\] only or ICS plus LABA) and treatment as two factors.||15.2|-25.6|0.612
71845853|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.66|-0.82|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.82|-1.66|<0.001
71845854|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.17||||0.14|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.06|-0.41|0.140
71845855|NCT00683800|143206510|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.56|-0.26|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.26|-0.56|<0.001
71845856|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.71|||<|0.001|TWO_SIDED|95.0|-2.42|-1.0|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-1.00|-2.42|<0.001
71845857|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.56|||<|0.001|TWO_SIDED|95.0|-0.81|-0.3|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.30|-0.81|<0.001
71845858|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.62|||<|0.001|TWO_SIDED|95.0|-0.83|-0.4|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.40|-0.83|<0.001
71845859|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.08||||0.082|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.01|-0.17|0.082
71845860|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.61|-0.75|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.75|-1.61|<0.001
71845861|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.02||||0.865|TWO_SIDED|95.0|-0.25|0.21|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||0.21|-0.25|0.865
71845862|NCT00683800|143206511|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.001|TWO_SIDED|95.0|-0.61|-0.29|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.||-0.29|-0.61|<0.001
71845863|NCT00683800|143206512|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845864|NCT00683800|143206513|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71677780|NCT00425061|142873993|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.482|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.482
71677781|NCT00425061|142873993|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.492|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.492
71677782|NCT00425061|142873993|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.323|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.323
71677783|NCT00425061|142873993|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.226|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.226
71677784|NCT00425061|142873993|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.256|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.2|0.256
71677785|NCT00425061|142873994|SUPERIORITY_OR_OTHER||LS mean difference|1.8||||0.09|TWO_SIDED|95.0|-0.3|3.9|||ANCOVA|||Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||3.9|-0.3|0.090
71677786|NCT00425061|142873994|SUPERIORITY_OR_OTHER||LS mean difference|2.1||||0.144|TWO_SIDED|95.0|-0.8|5.0|||ANCOVA|||Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||5.0|-0.8|0.144
71677787|NCT00425061|142873996|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.354|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.1|-0.4|0.354
71814343|NCT03502616|143130736|SUPERIORITY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.186|<|0.0001|TWO_SIDED|95.0|-1.26|-0.53|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.53|-1.26|<0.0001
71814344|NCT03502616|143130736|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.75|-0.92|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.92|-1.75|<0.0001
71845865|NCT00683800|143206514|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845866|NCT00683800|143206515|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845867|NCT00683800|143206516|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845868|NCT00683800|143206517|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845869|NCT00683800|143206518|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845870|NCT00683800|143206519|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845871|NCT00683800|143206520|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845872|NCT00683800|143206521|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845873|NCT00683800|143206522|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71845874|NCT00683800|143206523|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.||||<0.001
71677788|NCT00425061|142873996|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.9|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.900
71677789|NCT00425061|142873996|SUPERIORITY_OR_OTHER||LS mean difference|0.0||||0.921|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.4|-0.4|0.921
71677790|NCT00425061|142873996|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.388|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.6|-0.2|0.388
71677791|NCT00425061|142873996|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.249|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.||0.7|-0.2|0.249
71845875|NCT00683800|143206524|SUPERIORITY_OR_OTHER||Wald Formula|1.11|||||TWO_SIDED|90.0|-0.68|2.9|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||2.9|-0.68|
71845876|NCT00683800|143206526|SUPERIORITY_OR_OTHER||Wald Formula|2.31|||||TWO_SIDED|90.0|-2.08|6.71|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||6.71|-2.08|
71845877|NCT00683800|143206527|SUPERIORITY_OR_OTHER||Wald Formula|0.08|||||TWO_SIDED|90.0|-3.51|3.67|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.||3.67|-3.51|
71845878|NCT00229970|143206567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.022||95.0|0.01|0.16|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.16|0.01|0.022
71845879|NCT00229970|143206567|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|||<|0.001||95.0|0.09|0.24|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.||||0.24|0.09|<0.001
71897096|NCT01096667|143316667|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.19||||0.021|TWO_SIDED|80.0|-3.56|-0.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-0.82|-3.56|0.021
71897097|NCT01096667|143316668|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.99||||0.004|TWO_SIDED|80.0|-4.43|-1.55||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.55|-4.43|0.004
71897098|NCT01096667|143316668|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.75||||0.01|TWO_SIDED|80.0|-4.26|-1.24||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.24|-4.26|0.010
71897099|NCT01096667|143316668|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.64||||0.01|TWO_SIDED|80.0|-4.09|-1.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.19|-4.09|0.010
71897100|NCT01096667|143316668|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.57||||0.011|TWO_SIDED|80.0|-4.0|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.||||-1.13|-4.00|0.011
71897101|NCT01096667|143316669|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.5||||0.048|TWO_SIDED|80.0|-4.43|-0.57||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.57|-4.43|0.048
71897102|NCT01096667|143316669|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.54||||0.013|TWO_SIDED|80.0|-5.58|-1.51||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.51|-5.58|0.013
71897103|NCT01096667|143316669|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88||||0.111|TWO_SIDED|80.0|-3.82|0.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.09|-3.82|0.111
71897104|NCT01096667|143316669|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.58||||0.148|TWO_SIDED|80.0|-3.51|0.36||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.36|-3.51|0.148
71897105|NCT01096667|143316671|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.2||||0.196|TWO_SIDED|80.0|-3.01|0.6||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.60|-3.01|0.196
71897106|NCT01096667|143316671|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.05||||0.229|TWO_SIDED|80.0|-2.86|0.77||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.77|-2.86|0.229
71897107|NCT01096667|143316671|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.02||||0.017|TWO_SIDED|80.0|-4.83|-1.2||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.20|-4.83|0.017
71677792|NCT00425061|142873997|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||Chi-squared|||||||0.267
71897108|NCT01096667|143316671|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.84||||0.021|TWO_SIDED|80.0|-4.63|-1.06||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.06|-4.63|0.021
71897109|NCT01096667|143316673|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.22||||0.039|TWO_SIDED|80.0|-3.83|-0.61||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.61|-3.83|0.039
71897110|NCT01096667|143316673|SUPERIORITY_OR_OTHER||Difference in least squares means|0.07||||0.521|TWO_SIDED|80.0|-1.63|1.77||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.77|-1.63|0.521
71897111|NCT01096667|143316673|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.39||||0.031|TWO_SIDED|80.0|-4.02|-0.75||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.75|-4.02|0.031
71897112|NCT01096667|143316673|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.56||||0.11|TWO_SIDED|80.0|-3.19|0.07||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.07|-3.19|0.110
71897113|NCT01096667|143316674|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.38||||0.007|TWO_SIDED|80.0|-5.13|-1.63||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-1.63|-5.13|0.007
71897114|NCT01096667|143316674|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.48||||0.37|TWO_SIDED|80.0|-2.33|1.38||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||1.38|-2.33|0.370
71897115|NCT01096667|143316674|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.029|TWO_SIDED|80.0|-4.43|-0.87||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||-0.87|-4.43|0.029
71897116|NCT01096667|143316674|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.64||||0.118|TWO_SIDED|80.0|-3.42|0.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.13|-3.42|0.118
71897117|NCT01096667|143316675|SUPERIORITY_OR_OTHER||Difference in least squares means|0.02||||0.506|TWO_SIDED|80.0|-1.96|2.0||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||2.00|-1.96|0.506
71897118|NCT01096667|143316675|SUPERIORITY_OR_OTHER||Difference in least squares means|1.61||||0.838|TWO_SIDED|80.0|-0.49|3.71||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||3.71|-0.49|0.838
71897119|NCT01096667|143316675|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.82||||0.123|TWO_SIDED|80.0|-3.82|0.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.19|-3.82|0.123
71897120|NCT01096667|143316675|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.07||||0.246|TWO_SIDED|80.0|-3.06|0.93||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||0.93|-3.06|0.246
71677793|NCT00425061|142873998|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Chi-squared|||||||0.029
71677794|NCT02651155|142874041|SUPERIORITY_OR_OTHER||Median Values of CI|1.0||||0.003|TWO_SIDED|95.0|0.1|1.0|||Van Elteren Test|SBM was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|CI was estimated by inverting the hypothesis test.|||1.0|0.1|0.003
71677795|NCT05875025|142874064|OTHER||Adjusted mean difference|1.36||||0.442|TWO_SIDED|95.0|-2.28|4.99|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR2 at baseline as a covariate.||||4.99|-2.28|0.442
71677796|NCT05875025|142874065|OTHER||Adjusted mean difference|0.7||||0.553|TWO_SIDED|95.0|-1.73|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model, included treatment, subject, and period as fixed effects; PPR4 at baseline as a covariate.||||3.12|-1.73|0.553
71677797|NCT01489254|142874079|NON_INFERIORITY_OR_EQUIVALENCE|To conclude study sensitivity the combined active treatment groups Glatiramer 20 mg and Copaxone 20 mg needed to be superior to placebo.|Ratio (or Ratio of estimated means)|0.488|||||TWO_SIDED|95.0|0.365|0.651|||||Ratio of combined Glatiramer 20 mg + Copaxone 20 mg to placebo and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function. To assess study sensitivity, data of the active treatment groups and placebo were included in the model, resulting in the ratios and 95% CIs for the combined Glatiramer 20 mg and Copaxone 20 mg treatment group and the individual treatments over placebo.||0.651|0.365|
71677798|NCT01489254|142874079|NON_INFERIORITY_OR_EQUIVALENCE|To conclude equivalence between Glatiramer 20 mg and Copaxone 20 mg, efficacy in the combined active treatment groups needed to be superior to placebo (confirming study sensitivity) and the 2-sided 95% CI for the estimated ratio of Glatiramer 20 mg to Copaxone 20 mg needed to be fully enclosed in the prespecified equivalence margin (0.727 - 1.375).|Ratio (or Ratio of estimated means)|1.095|||||TWO_SIDED|95.0|0.883|1.36|||||Ratio of Glatiramer 20 mg to Copaxone 20 mg and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function including Glatiramer 20 mg and Copaxone 20 mg treatment groups to assess study equivalence.||1.360|0.883|
71677799|NCT01945970|142874083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.36|TWO_SIDED|95.0|-1.09|0.4|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.40|-1.09|0.36
71677800|NCT01945970|142874084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.18|TWO_SIDED|95.0|-0.24|1.28|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.28|-0.24|0.18
71814345|NCT03502616|143130736|SUPERIORITY||LS mean difference|-1.98|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.41|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.41|<0.0001
71677801|NCT01945970|142874085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.014|TWO_SIDED|95.0|-1.59|-0.19|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||-0.19|-1.59|0.014
71814346|NCT03502616|143130736|SUPERIORITY||LS mean difference|-1.89|STANDARD_ERROR_OF_MEAN|0.245|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.37|<0.0001
71814347|NCT03502616|143130736|SUPERIORITY||LS mean difference|-1.62|STANDARD_ERROR_OF_MEAN|0.243|<|0.0001|TWO_SIDED|95.0|-2.1|-1.14|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.14|-2.10|<0.0001
71814348|NCT03502616|143130736|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.261||0.0492|TWO_SIDED|95.0|-1.03|0.0|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-1.03|0.0492
71814349|NCT03502616|143130736|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.266||0.2614|TWO_SIDED|95.0|-0.82|0.22|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.22|-0.82|0.2614
71814350|NCT03502616|143130736|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.272||0.0722|TWO_SIDED|95.0|-1.03|0.04|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.04|-1.03|0.0722
71845880|NCT01700205|143206568|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.018|||<|0.05|TWO_SIDED|95.0|-0.0363|-0.0002|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.||||-0.0002|-0.0363|<0.05
71814351|NCT03502616|143130736|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.275||0.0121|TWO_SIDED|95.0|-1.24|-0.15|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.15|-1.24|0.0121
71897121|NCT01096667|143316677|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.2||||0.005|TWO_SIDED|80.0|-6.3|-2.1||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-2.10|-6.30|0.005
71814352|NCT03502616|143130737|SUPERIORITY||LS mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.207|<|0.0001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.51|-1.33|<0.0001
71814353|NCT03502616|143130737|SUPERIORITY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.216|<|0.0001|TWO_SIDED|95.0|-2.02|-1.17|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.17|-2.02|<0.0001
71814354|NCT03502616|143130737|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.244|<|0.0001|TWO_SIDED|95.0|-2.5|-1.54|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.54|-2.50|<0.0001
71814355|NCT03502616|143130737|SUPERIORITY||LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.254|<|0.0001|TWO_SIDED|95.0|-2.5|-1.5|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.50|-2.50|<0.0001
71814356|NCT03502616|143130737|SUPERIORITY||LS mean difference|-1.84|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.35|-1.32|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.32|-2.35|<0.0001
71814357|NCT03502616|143130737|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.274||0.0785|TWO_SIDED|95.0|-1.02|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-1.02|0.0785
71814358|NCT03502616|143130737|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.3047|TWO_SIDED|95.0|-0.82|0.26|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.26|-0.82|0.3047
71814359|NCT03502616|143130737|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.283||0.1009|TWO_SIDED|95.0|-1.02|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-1.02|0.1009
71814360|NCT03502616|143130737|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.287||0.0764|TWO_SIDED|95.0|-1.08|0.05|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.05|-1.08|0.0764
71814361|NCT03502616|143130738|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.159||0.0089|TWO_SIDED|95.0|-0.73|-0.11|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.11|-0.73|0.0089
71814362|NCT03502616|143130738|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.179|<|0.0001|TWO_SIDED|95.0|-1.12|-0.42|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.42|-1.12|<0.0001
71814363|NCT03502616|143130738|SUPERIORITY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.202|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.70|-1.50|<0.0001
71814364|NCT03502616|143130738|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.71|-0.88|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.88|-1.71|<0.0001
71814365|NCT03502616|143130738|SUPERIORITY||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.66|-0.8|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.80|-1.66|<0.0001
71814366|NCT03502616|143130738|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.242||0.1686|TWO_SIDED|95.0|-0.81|0.14|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.14|-0.81|0.1686
71897122|NCT01096667|143316677|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.12||||0.248|TWO_SIDED|80.0|-3.23|0.99||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||0.99|-3.23|0.248
71897123|NCT01096667|143316677|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.84||||0.01|TWO_SIDED|80.0|-5.95|-1.73||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.73|-5.95|0.010
71897124|NCT01096667|143316677|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.33||||0.02|TWO_SIDED|80.0|-5.4|-1.25||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.||||-1.25|-5.40|0.020
71897125|NCT01096667|143316679|SUPERIORITY_OR_OTHER||Difference in least squares means|42.18||||0|TWO_SIDED|80.0|31.42|52.94||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||52.94|31.42|0.000
71897126|NCT01096667|143316679|SUPERIORITY_OR_OTHER||Difference in least squares means|60.39||||0|TWO_SIDED|80.0|49.47|71.31||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||71.31|49.47|0.000
71897127|NCT01096667|143316679|SUPERIORITY_OR_OTHER||Difference in least squares means|70.34||||0|TWO_SIDED|80.0|59.58|81.1||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||81.10|59.58|0.000
71897128|NCT01096667|143316679|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.63||||0.713|TWO_SIDED|80.0|-15.22|5.96||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.||||5.96|-15.22|0.713
71897129|NCT01096667|143316681|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1||||0.007|TWO_SIDED|80.0|-27.45|-8.75||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-8.75|-27.45|0.007
71897130|NCT01096667|143316681|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.81||||0|TWO_SIDED|80.0|-44.19|-25.43||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-25.43|-44.19|0.000
71897131|NCT01096667|143316681|SUPERIORITY_OR_OTHER||Difference in least squares means|-35.42||||0|TWO_SIDED|80.0|-44.78|-26.07||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-26.07|-44.78|0.000
71897132|NCT01096667|143316681|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.61||||0.467|TWO_SIDED|80.0|-9.86|8.65||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||8.65|-9.86|0.467
71897133|NCT01096667|143316682|SUPERIORITY_OR_OTHER||Difference in least squares means|-5.54||||0.224|TWO_SIDED|80.0|-14.89|3.82||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||3.82|-14.89|0.224
71897134|NCT01096667|143316682|SUPERIORITY_OR_OTHER||Difference in least squares means|-17.0||||0.011|TWO_SIDED|80.0|-26.39|-7.61||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-7.61|-26.39|0.011
71897135|NCT01096667|143316682|SUPERIORITY_OR_OTHER||Difference in least squares means|-26.59||||0|TWO_SIDED|80.0|-35.84|-17.33||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||-17.33|-35.84|0.000
71897136|NCT01096667|143316682|SUPERIORITY_OR_OTHER||Difference in least squares means|8.65||||0.886|TWO_SIDED|80.0|-0.56|17.87||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.||||17.87|-0.56|0.886
71897137|NCT03425656|143316704|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.|Mean Difference (Net)|-0.03||||0.73|TWO_SIDED|95.0|-0.23|0.16|||Chi-squared|||||0.16|-0.23|0.73
71897138|NCT03425656|143316705|OTHER|||||||0.72|||||||Fisher Exact|||||||0.72
71897139|NCT03425656|143316706|OTHER||Chi-squared|0.42||||0.42|TWO_SIDED||||||Chi-squared|||||||0.42
71897140|NCT03425656|143316707|NON_INFERIORITY|We used a non-inferiority margin of 0.25 for the primary endpoint.||||||0.59|||||||Chi-squared|||||||0.59
71897141|NCT01507246|143316709|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.62||||0.0251|TWO_SIDED|95.0|1.14|6.03|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.||6.03|1.14|0.0251
71897142|NCT01507246|143316710|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.24||||0.02767|TWO_SIDED|95.0|1.03|1.49|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis = distribution of costs is identical between the two groups.||1.49|1.03|0.02767
71897143|NCT01438710|143316725|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED|95.0|||||t-test, 2 sided|||The mean change (i.e., absolute change) from baseline (Day 7, pre-conversion) on FTM overall score to Day 14 (post-conversion) was evaluated using paired t-test (at 0.05 significance level, two sided). An estimation of mean change from baseline and the corresponding 95% confidence interval (CI) were provided.||||0.0048
71921814|NCT04269629|143364756|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.16||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.16
71677802|NCT01945970|142874086|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.49||||0.22|TWO_SIDED|95.0|-1.3|0.31|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.31|-1.30|0.22
71677803|NCT01945970|142874087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.09|TWO_SIDED|95.0|-0.11|1.53|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.53|-0.11|0.09
71677804|NCT01945970|142874088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.32|TWO_SIDED|95.0|-1.13|0.37|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.37|-1.13|0.32
71845881|NCT01700205|143206569|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.|Slope|-0.023||||0.001|TWO_SIDED|95.0|-0.0362|-0.0093|||Generalized Estimating Equations|GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.||||-0.0093|-0.0362|0.001
71677805|NCT01945970|142874089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.89||||0.14|TWO_SIDED|95.0|-0.61|4.39|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||4.39|-0.61|0.14
71677806|NCT01945970|142874090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED|95.0|-2.41|1.62|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo|||1.62|-2.41|0.69
71677807|NCT01945970|142874091|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.44||||0.72|TWO_SIDED|95.0|-2.06|2.95|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.95|-2.06|0.72
71677808|NCT01945970|142874092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.39|TWO_SIDED|95.0|-1.15|2.88|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo|||2.88|-1.15|0.39
71814367|NCT03502616|143130738|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.238||0.28|TWO_SIDED|95.0|-0.72|0.21|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.21|-0.72|0.2800
71814368|NCT03502616|143130738|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.243||0.1135|TWO_SIDED|95.0|-0.86|0.09|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.09|-0.86|0.1135
71814369|NCT03502616|143130738|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.247||0.2496|TWO_SIDED|95.0|-0.77|0.2|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.20|-0.77|0.2496
71814370|NCT03502616|143130739|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-1.22|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.47|-1.22|<0.0001
71814371|NCT03502616|143130739|SUPERIORITY||LS mean difference|-1.48|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.89|-1.07|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.07|-1.89|<0.0001
71814372|NCT03502616|143130739|SUPERIORITY||LS mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.228|<|0.0001|TWO_SIDED|95.0|-2.06|-1.16|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.16|-2.06|<0.0001
71814373|NCT03502616|143130739|SUPERIORITY||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-2.34|-1.4|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.40|-2.34|<0.0001
71814374|NCT03502616|143130739|SUPERIORITY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|0.236|<|0.0001|TWO_SIDED|95.0|-2.18|-1.25|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.25|-2.18|<0.0001
71814375|NCT03502616|143130739|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.245||0.0385|TWO_SIDED|95.0|-0.99|-0.03|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-0.99|0.0385
71814376|NCT03502616|143130739|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.0463|TWO_SIDED|95.0|-1.0|-0.01|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.01|-1.00|0.0463
71897144|NCT04192448|143316730|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|1.82||||0.28|TWO_SIDED|95.0|-29.82|26.19|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of sexual aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||26.19|-29.82|.28
71897145|NCT04192448|143316730|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-1.0||||0.39|TWO_SIDED|95.0|-33.01|35.01|||t-test, 1 sided|This t-test examined the difference in sexual aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of sexual aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||35.01|-33.01|.39
71897146|NCT04192448|143316731|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.25||||0.33|TWO_SIDED|95.0|-2.88|2.63|||t-test, 1 sided|This t-test examined the difference in physical aggression intentions between those in the Alcohol Condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of physical aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.63|-2.88|.33
71897147|NCT04192448|143316731|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.25||||0.33|TWO_SIDED|95.0|-2.53|2.88|||t-test, 1 sided|The t-test examined the difference in physical aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Anger condition and those in the Control condition. A negative value indicates greater likelihood of physical aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||2.88|-2.53|.33
71897148|NCT04192448|143316732|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|0.67||||0.23|TWO_SIDED|95.0|-8.0|6.67|||t-test, 1 sided|The t-test examined differences in psychological aggression intentions between those in the Alcohol condition and those in the Sober condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A positive value indicates greater likelihood of psych aggression among those in the Alcohol condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||6.67|-8.00|.23
71897149|NCT04192448|143316732|OTHER|Target sample size was 200 participants. Power calculation was determined using nQuery version 8.4.1 for the 2x2 design, using 50 subject per group (including a conservative 10% dropout). Power calculation estimated 80% power to detect an effect size of 0.3 in both factors with no interaction, and greater power if there is an interaction effect. Current enrollment indicates study is underpowered. Because there are not enough participants to conduct an ANOVA or ANCOVA, t-tests were conducted.|Mean Difference (Final Values)|-0.17||||0.44|TWO_SIDED|95.0|-10.84|11.17|||t-test, 1 sided|The t-test examined the difference in psychological aggression intentions between those in the Anger condition and those in the Control condition.|The estimation parameter refers to the mean difference in the outcome between those in the Alcohol condition and those in the Sober condition. A negative value indicates greater likelihood of psych aggression among those in the Control condition.|The number of participants enrolled in the study constrained the type of statistical analyses able to be conducted. Indeed, the Sober x Anger condition could not be compared to the other arms because no participants were randomly assigned to that arm.||11.17|-10.84|.44
71897150|NCT00128206|143316739|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.51|||>|0.05||95.0|0.13|2.01|||Chi-squared|||The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.||2.01|.13|>.05
71897151|NCT02940886|143316742|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.13|0.13|||||Mixed Model for Repeated Measurement was used for testing and included the fixed categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.13|-0.13|
71897152|NCT02940886|143316743|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.88||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.88|0.06|
71897153|NCT02940886|143316743|OTHER||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-0.91|0.71||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.71|-0.91|
71845882|NCT01700205|143206570|OTHER|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.02||||0.32|TWO_SIDED|95.0|-0.058|0.019|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction||||0.019|-0.058|0.32
71897154|NCT02940886|143316743|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
71897155|NCT02940886|143316744|SUPERIORITY|||||||0.5695|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.5695
71897156|NCT02940886|143316745|SUPERIORITY|||||||0.3913|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.3913
71897157|NCT02940886|143316747|SUPERIORITY||Odds Ratio (OR)|2.44||||0.0077|TWO_SIDED|95.0|1.27|4.72|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥2 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||4.72|1.27|0.0077
71897158|NCT02940886|143316747|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.8|3.26|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥2 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||3.26|1.80|<0.0001
71897159|NCT02940886|143316747|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1049|TWO_SIDED|95.0|0.96|1.58|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥2 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.58|0.96|0.1049
71897160|NCT02940886|143316747|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7032|TWO_SIDED|95.0|0.8|1.38|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥2 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.38|0.80|0.7032
71897161|NCT02940886|143316748|SUPERIORITY|||||||0.088|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0880
71897162|NCT02940886|143316749|SUPERIORITY||Odds Ratio (OR)|1.14||||0.242|TWO_SIDED|95.0|0.92|1.41|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.41|0.92|0.2420
71845883|NCT01700205|143206571|OTHER|ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample|||||<|0.05|||||||Repeated Measures ANOVA|We conducted a ANOVA with group (CMF, EHF) as between-subject factor.||ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.||||<0.05
71897163|NCT02940886|143316750|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8746|TWO_SIDED|95.0|0.81|1.28|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.28|0.81|0.8746
71897164|NCT02940886|143316751|SUPERIORITY||Odds Ratio (OR)|4.52|||<|0.0001|TWO_SIDED|95.0|3.58|5.71|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||5.71|3.58|<0.0001
71897165|NCT02940886|143316752|SUPERIORITY||Mean Difference (Final Values)|0.26|||<|0.0001|TWO_SIDED|95.0|0.19|0.34|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.34|0.19|<0.0001
71897166|NCT02940886|143316752|SUPERIORITY||Mean Difference (Final Values)|0.29|||<|0.0001|TWO_SIDED|95.0|0.19|0.38|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.38|0.19|<0.0001
71897167|NCT02940886|143316752|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.1091|TWO_SIDED|95.0|-0.02|0.2|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.20|-0.02|0.1091
71897168|NCT02940886|143316753|SUPERIORITY||Mean Difference (Final Values)|267.7|||<|0.0001|TWO_SIDED|95.0|246.3|289.0|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||289.0|246.3|<0.0001
71897169|NCT02940886|143316753|SUPERIORITY||Mean Difference (Final Values)|41.7|||<|0.0001|TWO_SIDED|95.0|25.6|57.8|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||57.8|25.6|<0.0001
71897170|NCT02940886|143316753|SUPERIORITY||Mean Difference (Final Values)|-9.0||||0.115|TWO_SIDED|95.0|-20.3|2.2|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.2|-20.3|0.1150
71897171|NCT02940886|143316753|SUPERIORITY||Mean Difference (Final Values)|-8.3||||0.0812|TWO_SIDED|95.0|-17.7|1.0|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.0|-17.7|0.0812
71897172|NCT02940886|143316754|SUPERIORITY||Mean Difference (Final Values)|11.4|||<|0.0001|TWO_SIDED|95.0|10.1|12.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||12.7|10.1|<0.0001
71897173|NCT02940886|143316754|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.0001|TWO_SIDED|95.0|1.2|3.6|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||3.6|1.2|0.0001
71897174|NCT02940886|143316754|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.0162|TWO_SIDED|95.0|0.2|2.1|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.1|0.2|0.0162
71897175|NCT02940886|143316754|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.0569|TWO_SIDED|95.0|0.0|1.8|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.8|0.0|0.0569
71897176|NCT02940886|143316755|SUPERIORITY||Mean Difference (Final Values)|43.7|||<|0.0001|TWO_SIDED|95.0|38.1|49.3|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||49.3|38.1|<0.0001
71897177|NCT02940886|143316755|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0375|TWO_SIDED|95.0|0.3|9.8|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||9.8|0.3|0.0375
71845884|NCT01700205|143206572|OTHER|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||||||0.72|||||||Repeated Measure ANOVA|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor||||0.72
71677809|NCT01945970|142874093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.74|TWO_SIDED|95.0|-1.75|1.24|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||1.24|-1.75|0.74
71845885|NCT01700205|143206573|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.72|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.72
71845886|NCT01700205|143206574|OTHER|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.02|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||0.02
71845887|NCT00176202|143206599|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71897178|NCT02940886|143316755|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.6027|TWO_SIDED|95.0|-4.0|2.3|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.3|-4.0|0.6027
71897179|NCT02940886|143316755|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8207|TWO_SIDED|95.0|-2.7|3.4|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."||3.4|-2.7|0.8207
71897180|NCT02940886|143316756|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.0422|TWO_SIDED|95.0|0.04|2.01|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||2.01|0.04|0.0422
71897181|NCT02940886|143316756|SUPERIORITY||Mean Difference (Final Values)|-0.39||||0.4646|TWO_SIDED|95.0|-1.44|0.66|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.66|-1.44|0.4646
71897182|NCT02940886|143316756|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.5703|TWO_SIDED|95.0|-1.39|0.76|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.76|-1.39|0.5703
71897183|NCT01306058|143316777|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.05|||||||Wilcoxon signed rank test|||||||<0.05
71897184|NCT01306058|143316778|NON_INFERIORITY|Paired T-test. Two tailed.|||||<|0.0001||||||Cycle 1 day 15 vs. cycle 1 day 1|Wilcoxon signed rank test|||||||<0.0001
71897185|NCT01306058|143316778|NON_INFERIORITY|Cycle 2 day 1 vs. cycle 1 day 1. Paired T-test. Two tailed.|||||<|0.0001|||||||Wilcoxon signed rank test|||||||<0.0001
71897186|NCT01306058|143316778|NON_INFERIORITY|eos (end of study) vs. cycle 1 day 1. Paired T-test. Two tailed.||||||0.0009|||||||Wilcoxon signed rank test|||||||0.0009
71897187|NCT01666444|143316780|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.22||||0.923|ONE_SIDED|92.0||1.48||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).|Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.|The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.||1.48||0.923
71897188|NCT01666444|143316781|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.21||||0.943|ONE_SIDED|98.0||1.56||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (\<= 6 months vs \> 6 months), and performance status (0 vs 1).||The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.||1.56||0.943
71897189|NCT04011436|143316789|SUPERIORITY|In the bivariate analysis, a comparison was initially made of each of the domains of the Kujala test, for the assessment of pain at baseline, assessing the differences between the intervention groups using the chi-square or Fisher's exact tests. The Spearman correlation coefficient was used to evaluate the relationship between two continuous variables, such as Q angle and anterior knee pain, assessing the correlation marginally and conditionally on each of the treatment groups.|difference in frequency distribution|0.05|||<|0.05|TWO_SIDED|95.0|0.025|0.05|||Fisher Exact|we also used Chi-squared for the domains of pain and limp.||||0.05|0.025|<0.05
71845888|NCT00176202|143206599|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71845889|NCT00176202|143206600|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<.01
71845890|NCT00176202|143206600|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||||||0.01
71845891|NCT00176202|143206601|SUPERIORITY_OR_OTHER||effect size|-1.59|||<|0.01|TWO_SIDED|||||In case of both risperidone and divalproex sodium.|Chi-squared|||||||<0.01
71845892|NCT00176202|143206601|SUPERIORITY_OR_OTHER||Effect size|-1.33|||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71845893|NCT00176202|143206602|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||baseline is compared to LOCF to determine the p value.||||<0.01
71845894|NCT00176202|143206602|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared|||||||<0.01
71845895|NCT00853593|143206624|SUPERIORITY_OR_OTHER||One sample proportion|0.951|||||ONE_SIDED|95.0|0.906||||||The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).||||.906|
71845896|NCT00853593|143206625|SUPERIORITY_OR_OTHER||One sample mean|1.6|STANDARD_DEVIATION|1.4|||ONE_SIDED|95.0||1.8||||||||1.8||
71845897|NCT00853593|143206626|SUPERIORITY_OR_OTHER||One sample mean|2.3|STANDARD_DEVIATION|2.0|||ONE_SIDED|97.5||2.7||||||||2.7||
71845898|NCT00853593|143206627|SUPERIORITY_OR_OTHER||One sample proportion|0.927|||||TWO_SIDED|95.0|0.887|0.967||||||||.967|.887|
71845899|NCT00853593|143206628|SUPERIORITY_OR_OTHER||One sample proportion|0.969|||||TWO_SIDED|95.0|0.944|0.993||||||||.993|.944|
71845900|NCT00853593|143206629|SUPERIORITY_OR_OTHER||One sample proportion|0.959|||||TWO_SIDED|95.0|0.93|0.987||||||||.987|.930|
71845901|NCT00853593|143206630|SUPERIORITY_OR_OTHER||One sample proportion|0.948|||||TWO_SIDED|95.0|0.917|0.979||||||||.979|.917|
71845902|NCT00853593|143206636|SUPERIORITY_OR_OTHER||One sample mean|2.4|STANDARD_DEVIATION|1.9|||ONE_SIDED|95.0||2.7||||||||2.7||
71845903|NCT03758742|143206656|SUPERIORITY||||||<|0.0001|||||||Binomial Test|||||||<0.0001
71845904|NCT05966155|143206690|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.677|TWO_SIDED|95.0|-1.54|1.0|||t-test, 2 sided|||||1.00|-1.54|0.677
71845905|NCT05966155|143206691|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.1264|TWO_SIDED|95.0|-1.4|0.2|||t-test, 2 sided|||||0.2|-1.4|0.1264
71845906|NCT05966155|143206692|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.3692|TWO_SIDED|95.0|-0.4|1.1|||t-test, 2 sided||The by-group means and the estimated mean difference are independently rounded to the nearest tenth. As a result, the mean difference it not exactly equivalent to the difference in the two reported means.|||1.1|-0.4|0.3692
71845907|NCT05966155|143206693|SUPERIORITY|||||||0.8492|||||||Chi-squared|||||||0.8492
71845908|NCT05966155|143206694|SUPERIORITY|||||||0.0246|||||||Chi-squared|||||||0.0246
71845909|NCT05966155|143206695|SUPERIORITY|||||||0.0111|||||||Chi-squared|||||||0.0111
71845910|NCT05966155|143206696|SUPERIORITY|||||||0.0776|||||||Chi-squared|||||||0.0776
71845911|NCT05966155|143206697|SUPERIORITY|||||||0.0014|||||||Chi-squared|||||||0.0014
71845912|NCT01706159|143206701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.16||||0.3056||90.0|0.01|3.05||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher's exact test.||3.05|0.01|0.3056
71845913|NCT04119063|143206712|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.204|||||||t-test, 2 sided|||||||0.204
71845914|NCT04119063|143206713|OTHER|Paired t-test||||||0.049|||||||t-test, 2 sided|||||||0.049
71845915|NCT04119063|143206714|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.039|||||||t-test, 2 sided|||||||0.039
71845916|NCT04119063|143206715|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.242|||||||t-test, 2 sided|||||||0.242
71845917|NCT04119063|143206716|OTHER|Paired t-tests comparing change in % difference following high vs low frequency gait training.||||||0.014|||||||t-test, 2 sided|||||||.014
71845918|NCT03683576|143206727|SUPERIORITY||Odds Ratio (OR)|0.674||||0.1425|TWO_SIDED|95.0|0.398|1.142|||Regression, Logistic||GB001 20 mg vs. Placebo|||1.142|0.398|0.1425
71845919|NCT03683576|143206727|SUPERIORITY||Odds Ratio (OR)|0.677||||0.1482|TWO_SIDED|95.0|0.399|1.149|||Regression, Logistic||GB001 40 mg vs. Placebo|||1.149|0.399|0.1482
71845920|NCT03683576|143206727|SUPERIORITY||Odds Ratio (OR)|0.651||||0.1086|TWO_SIDED|95.0|0.385|1.1|||Regression, Logistic||GB001 60 mg vs. Placebo|||1.100|0.385|0.1086
71845921|NCT03683576|143206728|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1647|TWO_SIDED|95.0|-0.36|0.06|||ANCOVA||GB001 20 mg vs. Placebo|||0.06|-0.36|0.1647
71845922|NCT03683576|143206728|SUPERIORITY||Mean Difference (Net)|-0.15||||0.1737|TWO_SIDED|95.0|-0.37|0.07|||ANCOVA||GB001 40 mg vs. Placebo|||0.07|-0.37|0.1737
71845923|NCT03683576|143206728|SUPERIORITY||Mean Difference (Net)|-0.19||||0.0879|TWO_SIDED|95.0|-0.4|0.03|||ANCOVA||GB001 60 mg vs. Placebo|||0.03|-0.40|0.0879
71845924|NCT03683576|143206729|SUPERIORITY||Mean Difference (Net)|0.016||||0.7718|TWO_SIDED|95.0|-0.091|0.123|||ANCOVA||GB001 20 mg vs. Placebo|||0.123|-0.091|0.7718
71845925|NCT03683576|143206729|SUPERIORITY||Mean Difference (Net)|0.041||||0.4562|TWO_SIDED|95.0|-0.067|0.149|||ANCOVA||GB001 40 mg vs. Placebo|||0.149|-0.067|0.4562
71845926|NCT03683576|143206729|SUPERIORITY||Mean Difference (Net)|0.075||||0.1631|TWO_SIDED|95.0|-0.03|0.18|||ANCOVA||GB001 60 mg vs. Placebo|||0.180|-0.030|0.1631
71897190|NCT04011436|143316790|SUPERIORITY|For the analysis of the differences in medians between the groups, taking into account that the outcomes did not present a normal distribution, and assuming the assumption of independence of the variables, the non-parametric Mann-Whitney U test was used.|Median Difference (Final Values)|0.058|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was done for the assessment of change in pain with Visual Analogue Scale.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
71897191|NCT04011436|143316791|SUPERIORITY||Median Difference (Final Values)|0.75|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for Change in Patellofemoral Misalignment With Q Angle´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
71897192|NCT04011436|143316792|SUPERIORITY||Median Difference (Final Values)|0.001|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated Value was calculated for the change in core strength with McGill´s Exam.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
71897193|NCT04011436|143316793|SUPERIORITY||Median Difference (Final Values)|0.67|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||"Estimated value was calculated for the change in Quadriceps and Gluteus Strength With Squat´s Test.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||||<0.05
71897194|NCT04011436|143316794|SUPERIORITY||Median Difference (Final Values)|0.55|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in Static Balance with Single Leg Stance.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
71897195|NCT04011436|143316795|SUPERIORITY||Median Difference (Final Values)|0.492|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||||"Estimated value was calculated for the change in the total amount of Physical Activity reported in minutes.~The dispersion parameter that was calculated were interquartile ranges for the differences in medians between groups."|||<0.05
71897196|NCT00474630|143316826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.28|||<|0.001||95.0|-4.34|-2.22|||ANCOVA|||||-2.22|-4.34|<0.001
71897197|NCT00474630|143316827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||ANCOVA|||||-0.27|-0.71|<0.001
71897198|NCT00474630|143316828|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.15|5.5|||Regression, Logistic|||||5.50|2.15|<0.001
71897199|NCT00474630|143316829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.4||||0.007|TWO_SIDED||||||ANCOVA|||||||0.007
71897200|NCT00474630|143316830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.32|||<|0.001|TWO_SIDED|95.0|1.8|4.84|||ANCOVA|||||4.84|1.80|<0.001
71897201|NCT00474630|143316831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.85||||0.065|TWO_SIDED|95.0|-16.21|0.5|||ANCOVA|||||0.50|-16.21|0.065
71897202|NCT00474630|143316832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.08|||||TWO_SIDED|95.0|-3.57|-0.59||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.59|-3.57|
71897203|NCT00474630|143316833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75|||||TWO_SIDED|95.0|1.79|7.88||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.88|1.79|
71897204|NCT00474630|143316834|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||||TWO_SIDED|95.0|1.5|4.04||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.04|1.50|
71897205|NCT00474630|143316835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.35|0.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.86|0.35|
71897206|NCT00474630|143316836|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.27|7.57||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||7.57|0.27|
71897207|NCT00474630|143316837|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|0.55|12.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||12.67|0.55|
71897208|NCT00474630|143316838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.89|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71897209|NCT00474630|143316839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.13|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71897210|NCT00474630|143316840|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.36|5.14||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||5.14|1.36|
71897211|NCT00474630|143316841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37|||||TWO_SIDED|95.0|-0.77|3.51||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.51|-0.77|
71897212|NCT00474630|143316842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.62|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71897213|NCT00474630|143316844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.98|||||TWO_SIDED|95.0|-9.22|-0.74||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.74|-9.22|
71897214|NCT00474630|143316845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.43|||||TWO_SIDED|95.0|-7.48|4.62||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||4.62|-7.48|
71897215|NCT00474630|143316846|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|-1.02|3.33||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.33|-1.02|
71897216|NCT00474630|143316847|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.04|1.86||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.86|-1.04|
71897217|NCT00474630|143316848|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.62|||||TWO_SIDED|95.0|0.59|2.65||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.65|0.59|
71897218|NCT00474630|143316849|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43|||||TWO_SIDED|95.0|-0.42|1.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.27|-0.42|
71897219|NCT00474630|143316850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||||TWO_SIDED|96.0|-0.76|0.85||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.85|-0.76|
71897220|NCT00958568|143316856|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.||||<0.001
71897221|NCT00958568|143316857|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
71897222|NCT00958568|143316858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
71897223|NCT00958568|143316859|SUPERIORITY_OR_OTHER|||||||0.713||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.713
71845927|NCT03683576|143206730|SUPERIORITY||Hazard Ratio (HR)|0.719||||0.0466|TWO_SIDED|95.0|0.519|0.995|||Regression, Cox||GB001 20 mg vs. Placebo|||0.995|0.519|0.0466
71845928|NCT03683576|143206730|SUPERIORITY||Hazard Ratio (HR)|0.773||||0.1222|TWO_SIDED|95.0|0.558|1.071|||Regression, Cox||GB001 40 mg vs. Placebo|||1.071|0.558|0.1222
71845929|NCT03683576|143206730|SUPERIORITY||Hazard Ratio (HR)|0.698||||0.0304|TWO_SIDED|95.0|0.505|0.967|||Regression, Cox||GB001 60 mg vs. Placebo|||0.967|0.505|0.0304
71845930|NCT03683576|143206731|SUPERIORITY||Rate ratio|0.797||||0.3382|TWO_SIDED|95.0|0.501|1.268|||Negative binomial regression model||GB001 20 mg vs. Placebo|||1.268|0.501|0.3382
71845931|NCT03683576|143206731|SUPERIORITY||Rate ratio|0.748||||0.2248|TWO_SIDED|95.0|0.469|1.195|||Negative binomial regression model||GB001 40 mg vs. Placebo|||1.195|0.469|0.2248
71845932|NCT03683576|143206731|SUPERIORITY||Rate ratio|0.889||||0.609|TWO_SIDED|95.0|0.565|1.397|||Negative binomial regression model||GB001 60 mg vs. Placebo|||1.397|0.565|0.6090
71845933|NCT03683576|143206732|SUPERIORITY||Mean Difference (Net)|-0.023||||0.6645|TWO_SIDED|95.0|-0.127|0.081|||ANCOVA||GB001 20 mg vs. Placebo|||0.081|-0.127|0.6645
71845934|NCT03683576|143206732|SUPERIORITY||Mean Difference (Net)|0.035||||0.5288|TWO_SIDED|95.0|-0.074|0.144|||ANCOVA||GB001 40 mg vs. Placebo|||0.144|-0.074|0.5288
71845935|NCT03683576|143206732|SUPERIORITY||Mean Difference (Net)|0.079||||0.1362|TWO_SIDED|95.0|-0.025|0.182|||ANCOVA||GB001 60 mg vs. Placebo|||0.182|-0.025|0.1362
71845936|NCT03683576|143206733|SUPERIORITY||Mean Difference (Net)|6.122||||0.3957|TWO_SIDED|95.0|-8.007|20.251|||ANCOVA||GB001 20 mg vs. Placebo|||20.251|-8.007|0.3957
71845937|NCT03683576|143206733|SUPERIORITY||Mean Difference (Net)|13.948||||0.0598|TWO_SIDED|95.0|-0.578|28.474|||ANCOVA||GB001 40 mg vs. Placebo|||28.474|-0.578|0.0598
71845938|NCT03683576|143206733|SUPERIORITY||Mean Difference (Net)|5.588||||0.4376|TWO_SIDED|95.0|-8.522|19.698|||ANCOVA||GB001 60 mg vs. Placebo|||19.698|-8.522|0.4376
71845939|NCT05349721|143206786|OTHER||Treatment Difference|6.86||||0.516|TWO_SIDED|95.0|-13.86|27.59|||ANCOVA|Estimates were derived from the ANCOVA model (following multiple imputation), where participant ranks served as the response variable.||||27.59|-13.86|0.516
71845940|NCT03070392|143206800|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.37|0.71|||Log Rank|||||0.71|0.37|<0.0001
71845941|NCT03070392|143206802|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0139|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.0139
71845942|NCT03137459|143206820|SUPERIORITY||Risk Difference (RD)|0.059|||||TWO_SIDED|95.0|0.014|0.105|||||Analysis performed using GEE to account for clustering of participants within practices.|||.105|.014|
71845943|NCT03137459|143206820|SUPERIORITY||Odds Ratio (OR)|1.83|||||TWO_SIDED|95.0|1.14|2.93|||||Determined using mixed effects models, accounting for clustering of participants in practices and adjusting for unbalanced covariates: education, employment, stage of change for each ACP behavior|||2.93|1.14|
71845944|NCT03137459|143206821|SUPERIORITY||Risk Difference (RD)|0.082|||||TWO_SIDED|95.0|0.014|0.15|||||Adjusted for clustering|||.150|.014|
71677810|NCT01945970|142874094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.41|TWO_SIDED|95.0|-2.12|0.88|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|||0.88|-2.12|0.41
71845945|NCT03137459|143206821|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.96|2.0|||||Accounting for clustering and adjusted for covariates as described in primary outcome|||2.0|.96|
71897224|NCT00958568|143316860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||<0.001
71845946|NCT03137459|143206822|SUPERIORITY||Risk Difference (RD)|0.133|||||TWO_SIDED|95.0|0.066|0.201|||||Accounting for clustering|||.201|.066|
71845947|NCT03137459|143206822|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.22|2.47|||||Accounting for clustering and adjusted for covariates as presenting for primary outcome|||2.47|1.22|
71845948|NCT03137459|143206823|SUPERIORITY||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|-0.05|0.188||||||||.188|-.05|
71845949|NCT03137459|143206823|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.72|1.85|||||Accounting for clustering and adjusting for covariates as described for primary outcome|||1.85|.72|
71845950|NCT04921358|143206835|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.75|1.39|||||Hazard ratio and 95% confidence intervals (CIs) were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% Tumor Cells (TC) vs \>=1% TC).|||1.39|0.75|
71845951|NCT04921358|143206836|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.62|1.07|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||1.07|0.62|
71845952|NCT04921358|143206837|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.5|0.83|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by histological subtype (nonsquamous vs squamous), race (Asian vs Non-Asian) and PD-L1 expression (\<1% TC vs \>=1% TC).|||0.83|0.50|
71845953|NCT05646719|143206846|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.01|TWO_SIDED|95.0|1.23|4.2|||t-test, 2 sided|||||4.20|1.23|<0.01
71845954|NCT05646719|143206846|SUPERIORITY||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0||||||||||||
71845955|NCT02372799|143206847|SUPERIORITY||LSMD|-0.4||||0.7662|TWO_SIDED|95.0|-3.08|2.27|||MMRM|||||2.27|-3.08|0.7662
71845956|NCT02372799|143206847|SUPERIORITY||LSMD|-2.39||||0.1433|TWO_SIDED|95.0|-5.6|0.81|||MMRM|||||0.81|-5.60|0.1433
71845957|NCT02372799|143206848|SUPERIORITY||LSMD|-0.04||||0.7387|TWO_SIDED|95.0|-0.31|0.22|||MMRM|||||0.22|-0.31|0.7387
71845958|NCT02372799|143206848|SUPERIORITY||LSMD|-0.2||||0.2158|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||||0.12|-0.52|0.2158
71845959|NCT03499964|143206900|SUPERIORITY||||||<|0.0001|||||||Chi-squared, Corrected|||||||<0.0001
71845960|NCT03499964|143206902|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71882251|NCT02831673|143283287|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|-57.0|64.0|||||Age Group,35 to \<50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||64.0|-57.0|
71882252|NCT02831673|143283287|OTHER||Mean Difference (Net)|95.2|||||TWO_SIDED|95.0|-14.8|205.2|||||Age Group,\>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.|||205.2|-14.8|
71882253|NCT02831673|143283287|OTHER||Mean Difference (Net)|24.9|||||TWO_SIDED|95.0|-62.5|112.3|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||112.3|-62.5|
71882254|NCT02831673|143283287|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|95.0|-41.5|33.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.|||33.1|-41.5|
71882255|NCT02831673|143283287|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-40.6|41.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||41.1|-40.6|
71882256|NCT02831673|143283287|OTHER||Mean Difference (Net)|-51.3|||||TWO_SIDED|95.0|-163.6|60.9|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||60.9|-163.6|
71882257|NCT02831673|143283287|OTHER||Median Difference (Net)|-20.1|||||TWO_SIDED|95.0|-125.3|85.0|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction|||85.0|-125.3|
71882258|NCT02831673|143283287|OTHER||Mean Difference (Net)|66.2|||||TWO_SIDED|95.0|-43.7|176.2|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.|||176.2|-43.7|
71882259|NCT02831673|143283288|OTHER||Mean Difference (Net)|0.0052||||0.302|TWO_SIDED|95.0|-0.0047|0.0152|||MMRM||Week 4. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0152|-0.0047|0.302
71882260|NCT02831673|143283288|OTHER||Mean Difference (Net)|-0.0038||||0.45|TWO_SIDED|95.0|-0.0136|0.006|||MMRM||Week24. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0060|-0.0136|0.450
71882261|NCT02831673|143283288|OTHER||Mean Difference (Net)|0.0004||||0.934|TWO_SIDED|95.0|-0.0098|0.0106|||MMRM||Week48. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit with visit as the repeated factor|||0.0106|-0.0098|0.934
71882262|NCT02831673|143283289|OTHER||Mean Difference (Net)|-0.0012||||0.842|TWO_SIDED|95.0|-0.0132|0.0107|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0107|-0.0132|0.842
71897225|NCT00958568|143316861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
71897226|NCT00958568|143316862|SUPERIORITY_OR_OTHER|||||||0.831||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||0.831
71897227|NCT00958568|143316863|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||||||<0.001
71814377|NCT03502616|143130739|SUPERIORITY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.257||0.0126|TWO_SIDED|95.0|-1.15|-0.14|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.14|-1.15|0.0126
71814378|NCT03502616|143130739|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.268||0.0372|TWO_SIDED|95.0|-1.09|-0.03|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.09|0.0372
71814379|NCT03502616|143130740|SUPERIORITY||Difference in percentage|13.6|STANDARD_ERROR_OF_MEAN|3.53||0.0001|TWO_SIDED|95.0|6.68|20.52|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.52|6.68|0.0001
71814380|NCT03502616|143130740|SUPERIORITY||Difference in percentage|28.79|STANDARD_ERROR_OF_MEAN|4.6|<|0.0001|TWO_SIDED|95.0|19.78|37.8|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||37.80|19.78|<0.0001
71814381|NCT03502616|143130740|SUPERIORITY||Difference in percentage|33.31|STANDARD_ERROR_OF_MEAN|4.83|<|0.0001|TWO_SIDED|95.0|23.84|42.78|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.78|23.84|<0.0001
71814382|NCT03502616|143130740|SUPERIORITY||Difference in percentage|36.37|STANDARD_ERROR_OF_MEAN|4.95|<|0.0001|TWO_SIDED|95.0|26.67|46.07|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||46.07|26.67|<0.0001
71814383|NCT03502616|143130740|SUPERIORITY||Difference in percentage|36.34|STANDARD_ERROR_OF_MEAN|4.74|<|0.0001|TWO_SIDED|95.0|27.05|45.63|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||45.63|27.05|<0.0001
71814384|NCT03502616|143130740|SUPERIORITY||Difference in percentage|5.6|STANDARD_ERROR_OF_MEAN|5.99||0.3498|TWO_SIDED|95.0|-6.14|17.35|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.35|-6.14|0.3498
71814385|NCT03502616|143130740|SUPERIORITY||Difference in percentage|-2.4|STANDARD_ERROR_OF_MEAN|5.89||0.6835|TWO_SIDED|95.0|-13.96|9.15|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.15|-13.96|0.6835
71814386|NCT03502616|143130740|SUPERIORITY||Difference in percentage|-1.75|STANDARD_ERROR_OF_MEAN|5.98||0.7704|TWO_SIDED|95.0|-13.47|9.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.98|-13.47|0.7704
71814387|NCT03502616|143130740|SUPERIORITY||Difference in percentage|-1.13|STANDARD_ERROR_OF_MEAN|5.95||0.8492|TWO_SIDED|95.0|-12.8|10.53|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.53|-12.80|0.8492
71814388|NCT03502616|143130741|SUPERIORITY||Difference in percentage|2.24|STANDARD_ERROR_OF_MEAN|1.63||0.1692|TWO_SIDED|95.0|-0.95|5.43|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||5.43|-0.95|0.1692
71814389|NCT03502616|143130741|SUPERIORITY||Difference in percentage|4.46|STANDARD_ERROR_OF_MEAN|2.04||0.0289|TWO_SIDED|95.0|0.46|8.46|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.46|0.46|0.0289
71814390|NCT03502616|143130741|SUPERIORITY||Difference in percentage|6.02|STANDARD_ERROR_OF_MEAN|2.59||0.0199|TWO_SIDED|95.0|0.95|11.09|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.09|0.95|0.0199
71814391|NCT03502616|143130741|SUPERIORITY||Difference in percentage|12.03|STANDARD_ERROR_OF_MEAN|3.46||0.0005|TWO_SIDED|95.0|5.26|18.81|||Difference in percentage|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.81|5.26|0.0005
71814392|NCT03502616|143130741|SUPERIORITY||Difference in percentage|12.05|STANDARD_ERROR_OF_MEAN|3.45||0.0005|TWO_SIDED|95.0|5.29|18.8|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.80|5.29|0.0005
71814393|NCT03502616|143130741|SUPERIORITY||Difference in percentage|10.03|STANDARD_ERROR_OF_MEAN|4.49||0.0253|TWO_SIDED|95.0|1.24|18.83|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.83|1.24|0.0253
71814394|NCT03502616|143130741|SUPERIORITY||Difference in percentage|7.93|STANDARD_ERROR_OF_MEAN|4.75||0.095|TWO_SIDED|95.0|-1.38|17.24|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.24|-1.38|0.0950
71814395|NCT03502616|143130741|SUPERIORITY||Difference in percentage|7.21|STANDARD_ERROR_OF_MEAN|4.86||0.1377|TWO_SIDED|95.0|-2.31|16.73|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.73|-2.31|0.1377
71897228|NCT00958568|143316867|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.||||||0.047
71897229|NCT00958568|143316868|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.46|-1.36||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.36|-4.46|<0.001
71897230|NCT00958568|143316869|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.82|||<|0.001|TWO_SIDED|95.0|-5.39|-2.24||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-2.24|-5.39|<0.001
71897231|NCT00958568|143316870|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.11||0.002|TWO_SIDED|95.0|-0.55|-0.12||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-0.12|-0.55|0.002
71897232|NCT00958568|143316873|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|0.72||0.007|TWO_SIDED|95.0|-3.36|-0.53||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.||||-0.53|-3.36|0.007
71897233|NCT00958568|143316874|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71897234|NCT00958568|143316875|SUPERIORITY_OR_OTHER|||||||0.248||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.248
71814396|NCT03502616|143130741|SUPERIORITY||Difference in percentage|5.68|STANDARD_ERROR_OF_MEAN|4.91||0.2472|TWO_SIDED|95.0|-3.94|15.3|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.30|-3.94|0.2472
71814397|NCT03502616|143130742|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|-1.05|-0.41|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.41|-1.05|<0.0001
71897235|NCT00958568|143316876|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71897236|NCT00958568|143316877|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|4.47||0.839|TWO_SIDED|95.0|-9.71|7.89||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||7.89|-9.71|0.839
71897237|NCT00958568|143316878|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.352
71897238|NCT00958568|143316878|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71897239|NCT00958568|143316878|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71897240|NCT00958568|143316879|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|4.12||0.703|TWO_SIDED|95.0|-9.69|6.54||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||6.54|-9.69|0.703
71897241|NCT00958568|143316880|SUPERIORITY_OR_OTHER|||||||0.139||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.139
71814398|NCT03502616|143130742|SUPERIORITY||LS mean difference|-1.28|STANDARD_ERROR_OF_MEAN|0.187|<|0.0001|TWO_SIDED|95.0|-1.65|-0.91|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.91|-1.65|<0.0001
71814399|NCT03502616|143130742|SUPERIORITY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.92|-1.09|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.09|-1.92|<0.0001
71897242|NCT00958568|143316880|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.746
71897243|NCT00958568|143316880|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.458
71897244|NCT00958568|143316881|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.73|STANDARD_ERROR_OF_MEAN|1.15||0.001|TWO_SIDED|95.0|-5.99|-1.47||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||-1.47|-5.99|0.001
71897245|NCT00958568|143316882|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.004
71897246|NCT00958568|143316883|SUPERIORITY_OR_OTHER|||||||1||95.0||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71897247|NCT00958568|143316884|SUPERIORITY_OR_OTHER||LS Mean Difference|13.27|STANDARD_ERROR_OF_MEAN|7.62||0.083|TWO_SIDED|95.0|-1.72|28.26||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||28.26|-1.72|0.083
71897248|NCT00958568|143316885|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.029
71897249|NCT00958568|143316885|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.014
71897250|NCT00958568|143316885|SUPERIORITY_OR_OTHER|||||||0.054||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.054
71897251|NCT00958568|143316886|SUPERIORITY_OR_OTHER||LS Mean Difference|5.89|STANDARD_ERROR_OF_MEAN|1.87||0.002|TWO_SIDED|95.0|2.22|9.56||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||9.56|2.22|0.002
71897252|NCT00958568|143316887|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.031
71897253|NCT00958568|143316887|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||1.00
71897254|NCT00958568|143316887|SUPERIORITY_OR_OTHER|||||||0.344||95.0||||P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.344
71897255|NCT00958568|143316887|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.072
71897256|NCT00958568|143316888|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|2.96|4.88||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||4.88|2.96|<0.001
71677811|NCT01945970|142874095|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.74|TWO_SIDED|95.0|-1.11|1.54|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects||1.54|-1.11|0.74
71677812|NCT01945970|142874096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.66|TWO_SIDED|95.0|-1.84|1.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||1.17|-1.84|0.66
71677813|NCT01945970|142874097|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|95.0|-2.7|0.3|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo|||0.30|-2.70|0.11
71677814|NCT01945970|142874098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.55|TWO_SIDED|95.0|-0.93|1.73|||Mixed Models Analysis||Effect of positive control adjusted for placebo|||1.73|-0.93|0.55
71677815|NCT00782184|142874099|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.4|||<|0.001|TWO_SIDED|95.0|3.4|21.0|||Regression, Logistic|||COMPARISON BETWEEN GROUPS FOR NUMBER OF PARTICIPANTS REACHING LDL-C GOAL OF \<70 MG/DL||21.0|3.4|<0.001
71677816|NCT00782184|142874100|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-15.0|||<|0.001|TWO_SIDED|95.0|-21.15|-8.84|||Longitudinal Data Analysis (LDA) Model|||||-8.84|-21.15|<0.001
71677817|NCT00782184|142874101|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|3.3|13.9|||Regression, Logistic|||||13.9|3.3|<0.001
71677818|NCT00782184|142874102|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|6.0|||Regression, Logistic|||||6.0|2.0|<0.001
71677819|NCT00782184|142874103|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-8.24|||<|0.001|TWO_SIDED|95.0|-12.5|-3.97|||LDA Model|||||-3.97|-12.50|<0.001
71897257|NCT00958568|143316889|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was 0.05.|Fisher Exact|||||||<0.001
71677820|NCT00782184|142874104|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.13||||0.593|TWO_SIDED|95.0|-5.67|9.93|||LDA Model|||||9.93|-5.67|0.593
71677821|NCT00782184|142874105|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.48||||0.211|TWO_SIDED|95.0|-1.41|6.37|||LDA Model|||||6.37|-1.41|0.211
71677822|NCT00782184|142874106|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-11.62|||<|0.001|TWO_SIDED|95.0|-17.32|-5.92|||LDA Model|||||-5.92|-17.32|<0.001
71677823|NCT00782184|142874107|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-16.1|||<|0.001|TWO_SIDED|95.0|-22.77|-9.44|||LDA Model|||||-9.44|-22.77|<0.001
71677824|NCT00782184|142874108|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-10.02|||<|0.001|TWO_SIDED|95.0|-14.96|-5.08|||LDA Model|||||-5.08|-14.96|<0.001
71677825|NCT00782184|142874109|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-13.21|||<|0.001|TWO_SIDED|95.0|-19.83|-6.59|||LDA Model|||||-6.59|-19.83|<0.001
71677826|NCT00782184|142874110|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-7.69||||0.002|TWO_SIDED|95.0|-12.5|-2.88|||LDA Model|||||-2.88|-12.50|0.002
71677827|NCT00782184|142874111|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|5.25|||<|0.001|TWO_SIDED|95.0|2.44|8.06|||LDA Model|||||8.06|2.44|<0.001
71677828|NCT00782184|142874112|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-12.91|||<|0.001|TWO_SIDED|95.0|-18.31|-7.52|||LDA Model|||||-7.52|-18.31|<0.001
71677829|NCT00782184|142874113|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|2.68||||0.785|TWO_SIDED|95.0|-16.5|21.86|||LDA Model|||||21.86|-16.50|0.785
71677830|NCT01023256|142874131|SUPERIORITY_OR_OTHER|||||||0.095||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.095
71677831|NCT01023256|142874131|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||<0.0001
71677832|NCT01023256|142874131|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
71677833|NCT01023256|142874133|SUPERIORITY_OR_OTHER|||||||0.421||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.421
71677834|NCT01023256|142874133|SUPERIORITY_OR_OTHER|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.003
71897258|NCT00958568|143316890|SUPERIORITY_OR_OTHER|||||||0.392||95.0||||P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.392
71677835|NCT01023256|142874133|SUPERIORITY_OR_OTHER|||||||0.065||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.||||||0.065
71897259|NCT00958568|143316891|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.95||0.421|TWO_SIDED|95.0|-5.42|2.27||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.||||2.27|-5.42|0.421
71897260|NCT01591018|143316901|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||||||Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.|Chi-squared, Corrected|||Sample size was based on an expected 20% reduction of new ischemic lesions on DW-MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).||||<0.05
71897261|NCT02927171|143316931|OTHER|||||||0.17|||||||t-test, 1 sided|||||||0.17
71897262|NCT02677701|143316935|SUPERIORITY||Mean Difference (Net)|3.44||||0.0846|TWO_SIDED|95.0|-0.48|7.35|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||7.35|-0.48|0.0846
71897263|NCT02677701|143316936|SUPERIORITY||Mean Difference (Net)|1.31||||0.51|TWO_SIDED|95.0|-2.64|5.26|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||5.26|-2.64|0.51
71897264|NCT02677701|143316937|SUPERIORITY||Mean Difference (Net)|-2.89||||0.17|TWO_SIDED|95.0|-7.01|1.22|||Regression, Linear|Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).||||1.22|-7.01|0.17
71897265|NCT02677701|143316938|SUPERIORITY||Mean Difference (Net)|1.53||||0.56|TWO_SIDED|95.0|-3.7|6.77||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||6.77|-3.70|0.56
71897266|NCT02677701|143316939|SUPERIORITY||Mean Difference (Net)|0.75||||0.043|TWO_SIDED|95.0|0.03|1.47||Adjusted for baseline: ppFEV1 (25%-50%, \>50%-75%, \>75%), azithromycin use (current vs. non-current), inhaled tobramycin type (powder vs. solution).|Regression, Linear|||||1.47|0.03|0.043
71897267|NCT01720667|143316944|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of 24 hour seizure termination rates using a Fisher's exact test.||||<0.001
71897268|NCT01720667|143316945|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Comparison of seizure cessation at 48 hours using Fisher's exact test||||<0.001
71897269|NCT03472534|143316954|OTHER|The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71897270|NCT01221233|143317012|SUPERIORITY||Median Difference (Final Values)|17.6||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||1.000
71897271|NCT00611455|143317016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.67|4.91|||Cochran-Mantel-Haenszel|||||4.91|1.67|<0.001
71897272|NCT04382651|143317082|SUPERIORITY||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|2.225||0.33|TWO_SIDED|90.0|-2.7|4.7||1-Sided|ANCOVA|||||4.7|-2.7|0.33
71897273|NCT01873742|143317093|OTHER|The BDI's Cronbach's alpha was .93 at start of therapy, and .95 at the end of therapy.|Mean Difference (Final Values)|1.01|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71897274|NCT01753518|143317124|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
71897275|NCT01753518|143317125|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
71897276|NCT01753518|143317126|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||Comparison for staple expulsion or suture trimming||||0.25
71897277|NCT01753518|143317126|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Fisher Exact|||Comparison for Surgical Site Infection||||0.06
71897278|NCT01753518|143317126|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Fisher Exact|||Comparison for Superficial Wound Separation||||0.21
71897279|NCT01753518|143317126|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Fisher Exact|||Comparison for Seroma||||0.49
71897280|NCT01753518|143317126|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Fisher Exact|||Comparison for Hematoma||||0.50
71897281|NCT01753518|143317127|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Tylenol use.||||0.48
71897282|NCT01753518|143317127|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Ibuprofen use.||||0.30
71897283|NCT01753518|143317127|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Toradol use.||||0.85
71897284|NCT01753518|143317127|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Oxycodone use.||||0.78
71897285|NCT01753518|143317129|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||"Comparison for negative responses to Appearance of incision question."||||0.51
71897286|NCT01753518|143317129|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Chi-squared|||"Comparison for negative responses to Would recommend treatment to friends question."||||0.098
71897287|NCT01753518|143317129|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||"Comparison of negative responses to Willingness to use treatment again question."||||0.57
71897288|NCT01753518|143317129|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Fisher Exact|||"Comparison of negative responses to Overall satisfaction question."||||0.41
71897289|NCT01753518|143317130|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||Chi-squared|||"Comparison between arms for appearance of incision."||||0.85
71897290|NCT01753518|143317130|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Chi-squared|||"Comparison between arms for recommend treatment."||||0.004
71897291|NCT01753518|143317130|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"Comparison between arms for willingness to use treatment again."||||<0.001
71897292|NCT01753518|143317131|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71897293|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar painful.||||0.35
71897294|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar itching.||||0.48
71897295|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar color is different.||||0.034
71897296|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar stiffness is different.||||0.041
71897297|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar thickness is different.||||0.23
71897298|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar more irregular.||||0.13
71897299|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: overall opinion.||||0.11
71897300|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: vascularity.||||0.68
71897301|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pigmentation.||||0.18
71897302|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: thickness||||0.75
71897303|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: relief.||||0.36
71897304|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pliability.||||0.78
71897305|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: surface area.||||0.76
71897306|NCT01753518|143317132|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: overall opinion.||||0.97
71897307|NCT02075255|143317145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|33.3|||<|0.001|TWO_SIDED|95.0|16.7|50.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate is used.|||50.00|16.70|<0.001
71897308|NCT02075255|143317145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|37.5|||<|0.001|TWO_SIDED|95.0|20.8|50.0|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||50.00|20.80|<0.001
71897309|NCT02075255|143317146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.09|||<|0.001|TWO_SIDED|95.0|2.22|7.57|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.57|2.22|<0.001
71897310|NCT02075255|143317146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.12|||<|0.001|TWO_SIDED|95.0|2.22|7.63|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.||||7.63|2.22|<0.001
71897311|NCT02075255|143317147|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
71897312|NCT02075255|143317147|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|50.0|||<|0.001|TWO_SIDED|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.|||66.70|25.00|<0.001
71897313|NCT02075255|143317148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.79|7.22|||Cochran-Mantel-Haenszel|Controlling for region.||||7.22|1.79|<0.001
71897314|NCT02075255|143317148|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.57|5.86|||Cochran-Mantel-Haenszel|Controlling for region.||||5.86|1.57|<0.001
71897315|NCT02075255|143317149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23|||<|0.001|TWO_SIDED|95.0|1.92|14.21|||Cochran-Mantel-Haenszel|Controlling for region.||||14.21|1.92|<0.001
71897316|NCT02075255|143317149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19||||0.002|TWO_SIDED|95.0|1.58|11.12|||Cochran-Mantel-Haenszel|Controlling for region.||||11.12|1.58|0.002
71897317|NCT02075255|143317150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.012|TWO_SIDED|95.0|0.21|0.83|||Cochran-Mantel-Haenszel|Controlling for region.||||0.83|0.21|0.012
71897318|NCT02075255|143317150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.053|TWO_SIDED|95.0|0.27|1.01|||Cochran-Mantel-Haenszel|Controlling for region.||||1.01|0.27|0.053
71897319|NCT02075255|143317151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.6|6.23|||Cochran-Mantel-Haenszel|Controlling for region.||||6.23|1.60|<0.001
71897320|NCT02075255|143317151|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.002|TWO_SIDED|95.0|1.41|5.31|||Cochran-Mantel-Haenszel|Controlling for region.||||5.31|1.41|0.002
71897321|NCT02075255|143317152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.001|TWO_SIDED|95.0|0.16|0.65|||Cochran-Mantel-Haenszel|Controlling for region.||||0.65|0.16|0.001
71897322|NCT02075255|143317152|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.001|TWO_SIDED|95.0|0.14|0.56|||Cochran-Mantel-Haenszel|Controlling for region.||||0.56|0.14|<0.001
71897323|NCT02075255|143317153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.22|0.66|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.66|0.22|<0.001
71897324|NCT02075255|143317153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.001|TWO_SIDED|95.0|0.17|0.57|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.||||0.57|0.17|<0.001
71897325|NCT02075255|143317154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.291|TWO_SIDED|95.0|0.14|1.64|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||1.64|0.14|0.291
71897326|NCT02075255|143317154|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.12||||0.042|TWO_SIDED|95.0|0.01|0.63|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.||||0.63|0.01|0.042
71897327|NCT02075255|143317155|SUPERIORITY_OR_OTHER||Rate ratio|0.45||||0.003|TWO_SIDED|95.0|0.27|0.76|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.76|0.27|0.003
71897328|NCT02075255|143317155|SUPERIORITY_OR_OTHER||Rate ratio|0.3|||<|0.001|TWO_SIDED|95.0|0.17|0.53|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.||||0.53|0.17|<0.001
71897329|NCT02075255|143317156|SUPERIORITY_OR_OTHER||Rate ratio|0.44||||0.187|TWO_SIDED|95.0|0.13|1.49|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||1.49|0.13|0.187
71897330|NCT02075255|143317156|SUPERIORITY_OR_OTHER||Rate ratio|0.07||||0.018|TWO_SIDED|95.0|0.01|0.63|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.||||0.63|0.01|0.018
71897331|NCT02075255|143317158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.153|TWO_SIDED|95.0|-0.04|0.251|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.251|-0.040|0.153
71897332|NCT02075255|143317158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.112||||0.129|TWO_SIDED|95.0|-0.033|0.258|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.||||0.258|-0.033|0.129
71677836|NCT01023256|142874134|SUPERIORITY_OR_OTHER|||||||0.243||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included||||||0.243
71677837|NCT01023256|142874134|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P values \< 0.05 were considered significant.|Fisher Exact|Patients with missing values were not included||||||<0.0001
71897333|NCT02075255|143317159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.947|TWO_SIDED|95.0|-0.35|0.32|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.32|-0.35|0.947
71897334|NCT02075255|143317159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.291|TWO_SIDED|95.0|-0.51|0.16|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.16|-0.51|0.291
71897335|NCT02075255|143317160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.18|0.18|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.18|-0.18|0.998
71882263|NCT02831673|143283290|OTHER||Mean Difference (Net)|0.0008||||0.879|TWO_SIDED|95.0|-0.0097|0.0113|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||0.0113|-0.0097|0.879
71882264|NCT02831673|143283291|OTHER||Mean Difference (Net)|1.1||||0.137|TWO_SIDED|95.0|-0.3|2.4|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.4|-0.3|0.137
71882265|NCT02831673|143283291|OTHER||Mean Difference (Net)|0.6||||0.458|TWO_SIDED|95.0|-0.9|2.0|||MMRM||Week24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.0|-0.9|0.458
71882266|NCT02831673|143283291|OTHER||Mean Difference (Net)|1.5||||0.031|TWO_SIDED|95.0|0.1|2.8|||MMRM||Week48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment\*visit and Baseline EQ-5D thermometer\*visit with visit as the repeated factor|||2.8|0.1|0.031
71882267|NCT02831673|143283292|OTHER||Mean Difference (Net)|1.7||||0.027|TWO_SIDED|95.0|0.2|3.2|||MMRM||Week 96. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.2|0.2|0.027
71882268|NCT02831673|143283293|OTHER||Mean Difference (Net)|2.3||||0.001|TWO_SIDED|95.0|0.9|3.6|||MMRM||Week 144. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment\*visit and Baseline EQ-5D utility\*visit as factors and covariate, with visit as the repeated factor.|||3.6|0.9|0.001
71882269|NCT03615183|143283301|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.36|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.72%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
71882270|NCT03615183|143283301|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-1.63|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 99.86%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
71882271|NCT03615183|143283301|SUPERIORITY|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a LDA model containing fixed effects for study and time, and a random effect for participants.|Posterior Mean Difference|-0.92|||||||||||||PP of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8527 and placebo ≤ -1.0 copies/mL was 9.42%.|It was hypothesized that the true mean difference in the plasma HIV-1 RNA reduction from baseline between MK- 8527 and placebo is at least 1.0 log10 copies/mL.||||
71882272|NCT01977781|143283318|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Only the statistical analysis results for burning sensation at 10 weeks are reported below as they where the only tolerability results found to be significantly different between the two arms. All other tolerability measures were found to be the same between the two groups.||||0.0019
71882273|NCT01040351|143283358|NON_INFERIORITY_OR_EQUIVALENCE|. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)|Odds Ratio (OR)|3.02||||0.023|TWO_SIDED|95.0|1.13|8.0|||Chi-squared|||||8.0|1.13|0.023
71882274|NCT02605187|143283384|SUPERIORITY|||||||0.882||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.882
71882275|NCT02605187|143283384|SUPERIORITY|||||||0.565||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.||||0.565
71882276|NCT02605187|143283384|SUPERIORITY|||||||0.022||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.022
71882277|NCT02605187|143283384|SUPERIORITY|||||||0.14||||||Final parameter estimates would be considered significant at P \< 0.05.|ANOVA|||Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.||||0.140
71882278|NCT02605187|143283385|SUPERIORITY|||||||0.311||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 0-24 hours after delivery.||||0.311
71882279|NCT02605187|143283385|SUPERIORITY|||||||0.008||||||Final parameter estimates would be considered significant at P \< 0.05.|Fisher Exact|||Comparison of opioid use 24-48 hours after delivery.||||0.008
71882280|NCT02605187|143283386|SUPERIORITY|||||||0.092|||||||Fisher Exact|||Comparison of presence of pruritus 0-24 hours after delivery.||||0.092
71677838|NCT01023256|142874134|SUPERIORITY_OR_OTHER|||||||0.135||||||P values \<0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included.||||||0.135
71677839|NCT03155178|142874138|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|-0.53|0.07|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.07|-0.53|0.13
71677840|NCT03155178|142874138|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.78|TWO_SIDED|95.0|-0.23|0.3|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.30|-0.23|0.78
71677841|NCT03155178|142874138|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.77|TWO_SIDED|95.0|-0.38|0.29|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.29|-0.38|0.77
71677842|NCT03155178|142874138|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.15||0.37|TWO_SIDED|95.0|-0.45|0.17|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 48-hours post-treatment."||0.17|-0.45|0.37
71677843|NCT03155178|142874138|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.58|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 72-hours post-treatment."||0.58|-0.20|0.33
71677844|NCT03155178|142874138|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.16||0.65|TWO_SIDED|95.0|-0.25|0.39|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 recovery between arms at 96-hours post-treatment."||0.39|-0.25|0.65
71677845|NCT03155178|142874139|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.22||0.38|TWO_SIDED|95.0|-0.63|0.24|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.24|-0.63|0.38
71677846|NCT03155178|142874139|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.68|TWO_SIDED|95.0|-0.3|0.45|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||0.45|-0.30|0.68
71677847|NCT03155178|142874139|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.97|TWO_SIDED|95.0|-0.47|0.45|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.45|-0.47|0.97
71677848|NCT03155178|142874139|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.23||0.4|TWO_SIDED|95.0|-0.27|0.65|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."||0.65|-0.27|0.40
71677849|NCT03155178|142874139|SUPERIORITY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.25||0.03|TWO_SIDED|95.0|0.05|1.03||Using a Hochberg Step-up procedure the critical p value is 0.17|Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."||1.03|0.05|0.03
71814400|NCT03502616|143130742|SUPERIORITY||LS mean difference|-1.68|STANDARD_ERROR_OF_MEAN|0.221|<|0.0001|TWO_SIDED|95.0|-2.11|-1.24|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.24|-2.11|<0.0001
71814401|NCT03502616|143130742|SUPERIORITY||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.88|-1.0|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.00|-1.88|<0.0001
71677850|NCT03155178|142874139|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.23||0.07|TWO_SIDED|95.0|-0.03|0.87|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm\^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm\^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."||0.87|-0.03|0.07
71677851|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.|Least-Squares Mean Double Delta Value|-0.99|||||ONE_SIDED|95.0||0.635||||||"Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).~Power Calculation:~Enrollment of 72 subjects would provide at least 84% power to conclude a negative effect, given that up to 16 subjects may withdraw early prior to beginning to replace subjects (at least 56 subjects evaluable), and assuming a standard deviation of ΔΔQTcF of 7 msec and an underlying effect of 5 msec."||0.635||
71897336|NCT02075255|143317160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.177|TWO_SIDED|95.0|-0.3|0.05|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.05|-0.30|0.177
71897337|NCT02075255|143317161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.973|TWO_SIDED|95.0|-0.17|0.17|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.17|-0.17|0.973
71677852|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.59|||||ONE_SIDED|95.0||2.2||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.200||
71677853|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.17|||||ONE_SIDED|95.0||1.795||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.795||
71677854|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.42|||||ONE_SIDED|95.0||3.044||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.044||
71677855|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.792||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.792||
71677856|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.45|||||ONE_SIDED|95.0||2.074||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.074||
71814402|NCT03502616|143130742|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.235||0.088|TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.06|-0.86|0.0880
71897338|NCT02075255|143317161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.48|TWO_SIDED|95.0|-0.23|0.11|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.||||0.11|-0.23|0.480
71677857|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.83|||||ONE_SIDED|95.0||0.79||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||0.790||
71897339|NCT02075255|143317162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.397|TWO_SIDED|95.0|-1.44|0.57|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||0.57|-1.44|0.397
71897340|NCT02075255|143317162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.||||-0.41|-2.42|0.006
71897341|NCT02075255|143317163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.25||||0.143|TWO_SIDED|95.0|-6.58|45.07|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||45.07|-6.58|0.143
71897342|NCT02075255|143317163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.01||||0.023|TWO_SIDED|95.0|4.26|55.76|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.||||55.76|4.26|0.023
71897343|NCT02075255|143317164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19||||0.237|TWO_SIDED|95.0|-10.08|40.46|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||40.46|-10.08|0.237
71845961|NCT02909959|143206904|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|3.03||0.331|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.331
71845962|NCT02909959|143206905|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|2.99||0.98|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.98
71845963|NCT02909959|143206906|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-0.774|STANDARD_ERROR_OF_MEAN|2.99||0.797|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.797
71845964|NCT02909959|143206907|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|3.01||0.442|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.442
71845965|NCT02909959|143206908|EQUIVALENCE|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96\*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|2.72|STANDARD_ERROR_OF_MEAN|3.05||0.373|TWO_SIDED|||||The test was considered statistically significant if the p-value \< 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.||||0.373
71845966|NCT03739866|143206963|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71845967|NCT03739866|143206963|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71845968|NCT03739866|143206963|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71845969|NCT03739866|143206963|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71845970|NCT03739866|143206963|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71845971|NCT00853580|143206977|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
71845972|NCT00853580|143206978|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
71845973|NCT00853580|143206979|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
71845974|NCT00853580|143206980|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71845975|NCT00853580|143206981|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
71845976|NCT00853580|143206982|SUPERIORITY|||||||0.99|||||||ANCOVA|||||||0.99
71845977|NCT00853580|143206983|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||0.90
71845978|NCT00853580|143206984|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
71845979|NCT00853580|143206985|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||0.49
71845980|NCT00853580|143206986|SUPERIORITY|||||||0.86|||||||ANCOVA|||||||0.86
71845981|NCT00853580|143206987|SUPERIORITY|||||||0.09|||||||ANCOVA|||||||0.09
71845982|NCT00853580|143206988|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
71845983|NCT00853580|143206989|SUPERIORITY|||||||0.18|||||||ANCOVA|||||||0.18
71845984|NCT00853580|143206990|SUPERIORITY|||||||0.88|||||||ANCOVA|||||||0.88
71845985|NCT00853580|143206991|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||0.25
71845986|NCT00853580|143206992|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
71845987|NCT00853580|143206993|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||0.50
71845988|NCT00853580|143206994|SUPERIORITY|||||||0.33|||||||ANCOVA|||||||0.33
71845989|NCT00853580|143206995|SUPERIORITY|||||||0.3|||||||ANCOVA|||||||0.30
71845990|NCT00853580|143206996|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
71882281|NCT02605187|143283386|SUPERIORITY|||||||0.269|||||||Fisher Exact|||Comparison of presence of pruritus 24-48 hours after delivery.||||0.269
71882282|NCT02605187|143283387|SUPERIORITY|||||||0.006|||||||ANOVA|||Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equal||||0.006
71677858|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.03|||||ONE_SIDED|95.0||1.65||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.650||
71677859|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.53|||||ONE_SIDED|95.0||1.131||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.131||
71677860|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||ONE_SIDED|95.0||2.815||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||2.815||
71677861|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.36|||||ONE_SIDED|95.0||3.997||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.997||
71677862|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.18|||||ONE_SIDED|95.0||3.812||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.812||
71677863|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.59|||||ONE_SIDED|95.0||4.228||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.228||
71677864|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|3.04|||||ONE_SIDED|95.0||4.674||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||4.674||
71677865|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.63|||||ONE_SIDED|95.0||3.259||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.259||
71677866|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.07|||||ONE_SIDED|95.0||1.566||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||1.566||
71677867|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.82|||||ONE_SIDED|95.0||3.459||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.459||
71677868|NCT03613649|142874145|NON_INFERIORITY|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.72|||||ONE_SIDED|95.0||3.415||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).||3.415||
71677869|NCT03613649|142874150|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.19|||||ONE_SIDED|98.75|8.257|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 1 h after dose.|||8.257|
71677870|NCT03613649|142874150|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.79|||||ONE_SIDED|98.75|8.86|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 2 h after dose.|||8.860|
71845991|NCT01728324|143206997|SUPERIORITY_OR_OTHER||Adjusted response rate|81.1|||<|0.0001|TWO_SIDED|95.0|76.34|85.87|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.|The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).|The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||85.87|76.34|<0.0001
71814403|NCT03502616|143130742|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.241||0.0921|TWO_SIDED|95.0|-0.88|0.07|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.88|0.0921
71814404|NCT03502616|143130742|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.243||0.0597|TWO_SIDED|95.0|-0.94|0.02|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.02|-0.94|0.0597
71814405|NCT03502616|143130742|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.0492|TWO_SIDED|95.0|-0.99|0.0|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.00|-0.99|0.0492
71814406|NCT03502616|143130743|SUPERIORITY||Difference in percentage|8.31|STANDARD_ERROR_OF_MEAN|3.29||0.0116|TWO_SIDED|95.0|1.86|14.77|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.77|1.86|0.0116
71814407|NCT03502616|143130743|SUPERIORITY||Difference in percentage|22.74|STANDARD_ERROR_OF_MEAN|4.46|<|0.0001|TWO_SIDED|95.0|13.99|31.49|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.49|13.99|<0.0001
71814408|NCT03502616|143130743|SUPERIORITY||Difference in percentage|28.87|STANDARD_ERROR_OF_MEAN|4.99|<|0.0001|TWO_SIDED|95.0|19.09|38.66|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||38.66|19.09|<0.0001
71814409|NCT03502616|143130743|SUPERIORITY||Difference in percentage|31.93|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|22.28|41.58|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||41.58|22.28|<0.0001
71814410|NCT03502616|143130743|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|5.34|<|0.0001|TWO_SIDED|95.0|14.82|35.75|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||35.75|14.82|<0.0001
71814411|NCT03502616|143130743|SUPERIORITY||Difference in percentage|10.71|STANDARD_ERROR_OF_MEAN|5.88||0.0683|TWO_SIDED|95.0|-0.8|22.23|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.23|-0.80|0.0683
71814412|NCT03502616|143130743|SUPERIORITY||Difference in percentage|10.05|STANDARD_ERROR_OF_MEAN|5.94||0.0906|TWO_SIDED|95.0|-1.59|21.7|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||21.70|-1.59|0.0906
71814413|NCT03502616|143130743|SUPERIORITY||Difference in percentage|13.03|STANDARD_ERROR_OF_MEAN|5.94||0.0282|TWO_SIDED|95.0|1.39|24.66|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||24.66|1.39|0.0282
71814414|NCT03502616|143130743|SUPERIORITY||Difference in percentage|10.77|STANDARD_ERROR_OF_MEAN|5.98||0.0719|TWO_SIDED|95.0|-0.96|22.49|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||22.49|-0.96|0.0719
71814415|NCT03502616|143130744|SUPERIORITY||Difference in percentage|32.79|STANDARD_ERROR_OF_MEAN|4.75|<|0.0001|TWO_SIDED|95.0|23.48|42.11|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||42.11|23.48|<0.0001
71814416|NCT03502616|143130744|SUPERIORITY||Difference in percentage|40.53|STANDARD_ERROR_OF_MEAN|5.19|<|0.0001|TWO_SIDED|95.0|30.37|50.7|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||50.70|30.37|<0.0001
71814417|NCT03502616|143130744|SUPERIORITY||Difference in percentage|45.22|STANDARD_ERROR_OF_MEAN|5.2|<|0.0001|TWO_SIDED|95.0|35.03|55.41|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.41|35.03|<0.0001
71814418|NCT03502616|143130744|SUPERIORITY||Difference in percentage|45.23|STANDARD_ERROR_OF_MEAN|5.23|<|0.0001|TWO_SIDED|95.0|34.97|55.49|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||55.49|34.97|<0.0001
71814419|NCT03502616|143130744|SUPERIORITY||Difference in percentage|42.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|31.73|52.88|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||52.88|31.73|<0.0001
71814420|NCT03502616|143130744|SUPERIORITY||Difference in percentage|4.96|STANDARD_ERROR_OF_MEAN|5.85||0.3967|TWO_SIDED|95.0|-6.51|16.42|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.42|-6.51|0.3967
71814421|NCT03502616|143130744|SUPERIORITY||Difference in percentage|4.34|STANDARD_ERROR_OF_MEAN|5.67||0.4442|TWO_SIDED|95.0|-6.78|15.46|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.46|-6.78|0.4442
71814422|NCT03502616|143130744|SUPERIORITY||Difference in percentage|6.38|STANDARD_ERROR_OF_MEAN|5.92||0.281|TWO_SIDED|95.0|-5.22|17.97|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.97|-5.22|0.2810
71882283|NCT02605187|143283387|SUPERIORITY|||||||0.296|||||||ANOVA|||Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equal||||0.296
71677871|NCT03613649|142874150|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.62|||||ONE_SIDED|98.75|8.683|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 3 h after dose.|||8.683|
71814423|NCT03502616|143130744|SUPERIORITY||Difference in percentage|5.54|STANDARD_ERROR_OF_MEAN|5.95||0.3514|TWO_SIDED|95.0|-6.12|17.2|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||17.20|-6.12|0.3514
71814424|NCT03502616|143130745|SUPERIORITY||Difference in percentage|8.84|STANDARD_ERROR_OF_MEAN|2.74||0.0013|TWO_SIDED|95.0|3.46|14.21|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|3.46|0.0013
71897344|NCT02075255|143317164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.52||||0.014|TWO_SIDED|95.0|6.32|56.71|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.||||56.71|6.32|0.014
71897345|NCT02075255|143317165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.742|TWO_SIDED|95.0|-0.08|0.11|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.11|-0.08|0.742
71897346|NCT02075255|143317165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.693|TWO_SIDED|95.0|-0.11|0.07|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.||||0.07|-0.11|0.693
71897347|NCT02075255|143317166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.139|TWO_SIDED|95.0|-0.55|0.08|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||0.08|-0.55|0.139
71897348|NCT02075255|143317166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001|TWO_SIDED|95.0|-0.86|-0.23|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.||||-0.23|-0.86|0.001
71897349|NCT02075255|143317167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.658|TWO_SIDED|95.0|0.592|2.295|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||2.295|0.592|0.658
71897350|NCT02075255|143317167|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.661||||0.155|TWO_SIDED|95.0|0.826|3.34|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.||||3.340|0.826|0.155
71897351|NCT02075255|143317168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.151|TWO_SIDED|95.0|-0.08|0.53|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.53|-0.08|0.151
71814425|NCT03502616|143130745|SUPERIORITY||Difference in percentage|16.25|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|9.13|23.36|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||23.36|9.13|<0.0001
71882284|NCT02605187|143283388|SUPERIORITY|||||||0.759|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.||||0.759
71882285|NCT02605187|143283388|SUPERIORITY|||||||0.761|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.||||0.761
71882286|NCT02605187|143283389|SUPERIORITY|||||||0.281|||||||Chi-squared|||||||0.281
71882287|NCT02605187|143283390|SUPERIORITY|||||||0.786|||||||ANOVA|||Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equal||||0.786
71882288|NCT02605187|143283390|SUPERIORITY|||||||0.985|||||||ANOVA|||Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equal||||0.985
71882289|NCT02605187|143283391|SUPERIORITY|||||||0.057|||||||Chi-squared|||Comparison of participants who need nausea treatment from 0-24 hours after delivery.||||0.057
71882290|NCT02605187|143283391|SUPERIORITY|||||||0.246|||||||Fisher Exact|||Comparison of participants who need nausea treatment from 24-48 hours after delivery.||||0.246
71882291|NCT02605187|143283392|SUPERIORITY|||||||0.226|||||||ANOVA|||Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equal||||0.226
71882292|NCT02605187|143283393|SUPERIORITY|||||||0.036|||||||ANOVA|||||||0.036
71882293|NCT02605187|143283394|SUPERIORITY|||||||0.019|||||||ANOVA|||Comparison of satisfaction with pain medication 24 hours after delivery.||||0.019
71882294|NCT02605187|143283394|SUPERIORITY|||||||0.873|||||||ANOVA|||Comparison of satisfaction with pain medication 48 hours after delivery.||||0.873
71882295|NCT05433571|143283395|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (Low DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.917|STANDARD_ERROR_OF_MEAN|0.0194|||TWO_SIDED|95.0|0.878|0.955|||Bootstrapping Methods|bias adjusted confidence intervals||||0.955|0.878|
71882296|NCT05433571|143283395|SUPERIORITY|Superiority was tested for Senofilcon A (C3) Multifocal Toric lens with UV/HEV filter (High DC) and concluded if the lower limit of a 95% confidence interval was above 0.80|Mean Population Estimate|0.887|STANDARD_ERROR_OF_MEAN|0.0219|||TWO_SIDED|95.0|0.845|0.93|||Bootstrapping Methods|bias adjusted confidence intervals||||0.930|0.845|
71882297|NCT00847912|143283460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Log Rank|||||||0.93
71882298|NCT00847912|143283461|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.82|1.24|||Regression, Cox|||||1.24|0.82|0.93
71882299|NCT03070470|143283462|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|1.2|||||TWO_SIDED|90.0|-9.5|12.0||The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.|Mixed Models Analysis|||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||12.0|-9.5|
71677872|NCT03613649|142874150|NON_INFERIORITY|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.63|||||ONE_SIDED|98.75|8.698|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 4 h after dose.|||8.698|
71677873|NCT01500187|142874196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.636|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baseline||||0.636
71677874|NCT01500187|142874196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three months||||0.001
71677875|NCT01500187|142874196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.423|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six months||||0.423
71677876|NCT01551264|142874197|OTHER|P-value by chi-square comparing the Kaplan-Meier recurrence-free survival probability at 1.2 years post treatment with robust estimate of standard error due to the a priori assumption that data from bilateral limbs are correlated.||||||0.03|||||||Chi-squared|||||||0.03
71677877|NCT02572076|142874252|OTHER|Pilot study- no sample size was calculated|number of subjects with adequate cleansi|100.0|||||TWO_SIDED|95.0|66.0|100.0||||||patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.||100|66|
71677878|NCT00784550|142874285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71677879|NCT00784550|142874286|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71677880|NCT00784550|142874287|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
71677881|NCT00784550|142874288|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71677882|NCT00784550|142874289|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71677883|NCT00784550|142874290|SUPERIORITY_OR_OTHER|||||||0.069||95.0||||Mastery domain|ANCOVA|||||||0.069
71677884|NCT00784550|142874290|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||Fatigue domain|ANCOVA|||||||0.470
71677885|NCT00784550|142874290|SUPERIORITY_OR_OTHER|||||||0.394||95.0||||Emotional function domain|ANCOVA|||||||0.394
71677886|NCT00784550|142874290|SUPERIORITY_OR_OTHER|||||||0.879||95.0|||||ANCOVA|Dyspnea domain||||||0.879
71677887|NCT00688701|142874291|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.123|<|0.0001|TWO_SIDED|95.0|-0.785|-0.3||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.300|-0.785|<0.0001
71677888|NCT00688701|142874291|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-0.903|-0.423||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%), BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.423|-0.903|<0.0001
71882300|NCT03070470|143283462|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.6|||||TWO_SIDED|90.0|-11.4|6.1|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||6.1|-11.4|
71882301|NCT03070470|143283462|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.9|||||TWO_SIDED|90.0|-14.6|8.8|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% confidence interval (CI) to be \<10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model||8.8|-14.6|
71677889|NCT03681990|142874312|OTHER|Mixed Model ANOVA with subject as a random effect.||||||0.34||||||F test|ANOVA|||||||0.34
71677890|NCT00601172|142874332|SUPERIORITY_OR_OTHER||difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
71677891|NCT00601172|142874333|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.4771|TWO_SIDED|95.0|-1.8|3.8||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||3.8|-1.8|0.4771
71677892|NCT00601172|142874334|SUPERIORITY_OR_OTHER||Difference in percentage of participants|1.0||||0.7273|TWO_SIDED|95.0|-4.6|6.6|||Pooled Z test|p-value based on normal approximation to the binomial using a pooled Z test.|The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg||6.6|-4.6|0.7273
71677893|NCT00601172|142874335|SUPERIORITY_OR_OTHER||Treatment difference (%)|6.0||||0.0317|TWO_SIDED|95.0|0.5|11.5||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test|||Placebo vs Casopitant 90 mg||11.5|0.5|0.0317
71677894|NCT00601172|142874336|SUPERIORITY_OR_OTHER|||||||0.056|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-120 hours)||||0.0560
71677895|NCT00601172|142874336|SUPERIORITY_OR_OTHER|||||||0.0443|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-24 hours)||||0.0443
71677896|NCT00601172|142874336|SUPERIORITY_OR_OTHER|||||||0.1709|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (24-120 hours)||||0.1709
71677897|NCT00601172|142874337|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||2.3|-5.9|0.3986
71677898|NCT00601172|142874337|SUPERIORITY_OR_OTHER||Treatment difference (%)|-0.9||||0.3545|TWO_SIDED|95.0|-2.7|1.0|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.0|-2.7|0.3545
71677899|NCT00601172|142874337|SUPERIORITY_OR_OTHER||Treatment difference (%)|-1.8||||0.3986|TWO_SIDED|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||2.3|-5.9|0.3986
71677900|NCT00601172|142874338|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)||3.5|-5.4|0.6795
71677901|NCT00601172|142874338|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.4507|TWO_SIDED|95.0|-3.1|1.4|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)||1.4|-3.1|0.4507
71677902|NCT00601172|142874338|SUPERIORITY_OR_OTHER||Treament Difference (%)|-0.9||||0.6795|TWO_SIDED|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)||3.5|-5.4|0.6795
71814426|NCT03502616|143130745|SUPERIORITY||Difference in percentage|20.31|STANDARD_ERROR_OF_MEAN|4.03|<|0.0001|TWO_SIDED|95.0|12.41|28.2|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||28.20|12.41|<0.0001
71677903|NCT00601172|142874339|SUPERIORITY_OR_OTHER||Difference in percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||8.0|-3.8|0.4846
71677904|NCT00601172|142874339|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.8||||0.6101|TWO_SIDED|95.0|-2.3|3.9|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||3.9|-2.3|0.6101
71677905|NCT00601172|142874339|SUPERIORITY_OR_OTHER||Percentage of participants|2.1||||0.4846|TWO_SIDED|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||8.0|-3.8|0.4846
71677906|NCT00601172|142874340|SUPERIORITY_OR_OTHER||Difference in percentage of participants|3.8||||0.1356|TWO_SIDED|95.0|-1.2|8.9|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||8.9|-1.2|0.1356
71677907|NCT00601172|142874340|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||15.4|0.9|0.0280
71677908|NCT00601172|142874340|SUPERIORITY_OR_OTHER||Difference in percentage of participants|8.1||||0.028|TWO_SIDED|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||15.4|0.9|0.0280
71677909|NCT00601172|142874341|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||5.5|-7.3|0.7799
71677910|NCT00601172|142874341|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.5||||0.7883|TWO_SIDED|95.0|-3.2|4.2|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||4.2|-3.2|0.7883
71677911|NCT00601172|142874341|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.7799|TWO_SIDED|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||5.5|-7.3|0.7799
71677912|NCT00601172|142874342|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)||0.0|-15|0.0507
71814427|NCT03502616|143130745|SUPERIORITY||Difference in percentage|22.77|STANDARD_ERROR_OF_MEAN|4.24|<|0.0001|TWO_SIDED|95.0|14.46|31.08|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||31.08|14.46|<0.0001
71814428|NCT03502616|143130745|SUPERIORITY||Difference in percentage|25.28|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|16.47|34.1|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||34.10|16.47|<0.0001
71677913|NCT00601172|142874342|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-4.7||||0.08|TWO_SIDED|95.0|-9.9|0.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)||0.5|-9.9|0.0800
71677914|NCT00601172|142874342|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-7.3||||0.0507|TWO_SIDED|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)||0.0|-15|0.0507
71677915|NCT00601172|142874343|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-2.6|||||TWO_SIDED|97.5|-9.9|4.7|||||The parameter estimated was difference in percentage of participants with response.|Nausea Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||4.7|-9.9|
71677916|NCT00601172|142874343|SUPERIORITY_OR_OTHER||Difference in percentage of participants|0.7||||||97.5|-5.2|6.6|||||The parameter estimated was difference in percentage of participants with response.|Vomiting Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)||6.6|-5.2|
71677917|NCT00601172|142874344|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-120 hours) in Cycle 1||||0.1572
71677918|NCT00601172|142874344|SUPERIORITY_OR_OTHER|||||||0.2908|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-24 hours) in Cycle 1||||0.2908
71677919|NCT00601172|142874344|SUPERIORITY_OR_OTHER|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (24-120 hours) in Cycle 1||||0.1572
71897352|NCT02075255|143317168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.004|TWO_SIDED|95.0|0.14|0.76|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.||||0.76|0.14|0.004
71677920|NCT02461524|142874363|OTHER||Percentage|2.9|||<|0.001|ONE_SIDED|97.5||8.7|||Exact binomial test|||"The primary safety endpoint was tested against a predetermined safety Performance Goal (PG) using the following statistical hypotheses:~H0: p ≥ 20% vs. H1: p \< 20% where p is the proportion of subjects experiencing a Major Adverse Event (MAE) within 30 days of the index procedure in the target population of subjects treated with the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system and 20% is the safety PG."||8.7||<0.001
71814429|NCT03502616|143130745|SUPERIORITY||Difference in percentage|9.41|STANDARD_ERROR_OF_MEAN|5.62||0.0941|TWO_SIDED|95.0|-1.61|20.43|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||20.43|-1.61|0.0941
71814430|NCT03502616|143130745|SUPERIORITY||Difference in percentage|2.52|STANDARD_ERROR_OF_MEAN|5.96||0.6727|TWO_SIDED|95.0|-9.17|14.21|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||14.21|-9.17|0.6727
71897353|NCT02075255|143317169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.538||||0.22|TWO_SIDED|95.0|0.773|3.06|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.060|0.773|0.220
71897354|NCT02075255|143317169|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.783||||0.108|TWO_SIDED|95.0|0.882|3.605|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.||||3.605|0.882|0.108
71814431|NCT03502616|143130745|SUPERIORITY||Difference in percentage|7.29|STANDARD_ERROR_OF_MEAN|5.96||0.2213|TWO_SIDED|95.0|-4.39|18.98|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||18.98|-4.39|0.2213
71814432|NCT03502616|143130745|SUPERIORITY||Difference in percentage|4.7|STANDARD_ERROR_OF_MEAN|5.76||0.4137|TWO_SIDED|95.0|-6.58|15.98|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||15.98|-6.58|0.4137
71814433|NCT03502616|143130746|SUPERIORITY||Difference in percentage|0.75|STANDARD_ERROR_OF_MEAN|1.27||0.5518|TWO_SIDED|95.0|-1.73|3.24|||Cochran-Mantel-Haenszel|||Week 2: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||3.24|-1.73|0.5518
71814434|NCT03502616|143130746|SUPERIORITY||Difference in percentage|3.72|STANDARD_ERROR_OF_MEAN|1.92||0.0524|TWO_SIDED|95.0|-0.04|7.47|||Cochran-Mantel-Haenszel|||Week 4: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||7.47|-0.04|0.0524
71814435|NCT03502616|143130746|SUPERIORITY||Difference in percentage|5.25|STANDARD_ERROR_OF_MEAN|2.29||0.0216|TWO_SIDED|95.0|0.77|9.73|||Cochran-Mantel-Haenszel|||Week 8: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.73|0.77|0.0216
71814436|NCT03502616|143130746|SUPERIORITY||Difference in percentage|10.48|STANDARD_ERROR_OF_MEAN|2.9||0.0003|TWO_SIDED|95.0|4.8|16.17|||Cochran-Mantel-Haenszel|||Week 12: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||16.17|4.80|0.0003
71814437|NCT03502616|143130746|SUPERIORITY||Difference in percentage|6.69|STANDARD_ERROR_OF_MEAN|2.37||0.0047|TWO_SIDED|95.0|2.05|11.33|||Cochran-Mantel-Haenszel|||Week 16: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||11.33|2.05|0.0047
71814438|NCT03502616|143130746|SUPERIORITY||Difference in percentage|1.07|STANDARD_ERROR_OF_MEAN|3.98||0.7883|TWO_SIDED|95.0|-6.74|8.88|||Cochran-Mantel-Haenszel|||Week 24: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||8.88|-6.74|0.7883
71814439|NCT03502616|143130746|SUPERIORITY||Difference in percentage|4.85|STANDARD_ERROR_OF_MEAN|4.4||0.2708|TWO_SIDED|95.0|-3.78|13.48|||Cochran-Mantel-Haenszel|||Week 32: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||13.48|-3.78|0.2708
71814440|NCT03502616|143130746|SUPERIORITY||Difference in percentage|0.44|STANDARD_ERROR_OF_MEAN|4.55||0.9226|TWO_SIDED|95.0|-8.48|9.36|||Cochran-Mantel-Haenszel|||Week 40: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||9.36|-8.48|0.9226
71814441|NCT03502616|143130746|SUPERIORITY||Difference in percentage|1.84|STANDARD_ERROR_OF_MEAN|4.23||0.663|TWO_SIDED|95.0|-6.44|10.13|||Cochran-Mantel-Haenszel|||Week 48: Analysis performed using Normal approximation adjusting for the stratification factor derived from clinical database via CMH approach.||10.13|-6.44|0.6630
71814442|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.319||0.0099|TWO_SIDED|95.0|-1.47|-0.2|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.20|-1.47|0.0099
71814443|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.332||0.0275|TWO_SIDED|95.0|-1.4|-0.08|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.08|-1.40|0.0275
71814444|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.35||0.042|TWO_SIDED|95.0|-1.41|-0.03|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-0.03|-1.41|0.0420
71814445|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.349||0.1309|TWO_SIDED|95.0|-1.22|0.16|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.16|-1.22|0.1309
71814446|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.305||0.5566|TWO_SIDED|95.0|-0.78|0.42|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.42|-0.78|0.5566
71814447|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.248||0.4497|TWO_SIDED|95.0|-0.68|0.3|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.30|-0.68|0.4497
71814448|NCT03502616|143130747|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9272|TWO_SIDED|95.0|-0.43|0.47|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.47|-0.43|0.9272
71814449|NCT03502616|143130747|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.273||0.2539|TWO_SIDED|95.0|-0.85|0.23|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.23|-0.85|0.2539
71814450|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.479||0.4379|TWO_SIDED|95.0|-0.58|1.33|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.33|-0.58|0.4379
71814451|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.532||0.534|TWO_SIDED|95.0|-0.73|1.39|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.39|-0.73|0.5340
71814452|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.582||0.9148|TWO_SIDED|95.0|-1.1|1.22|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.22|-1.10|0.9148
71814453|NCT03502616|143130748|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.548||0.5409|TWO_SIDED|95.0|-1.43|0.76|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.76|-1.43|0.5409
71814454|NCT03502616|143130748|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.607||0.3555|TWO_SIDED|95.0|-1.78|0.65|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.65|-1.78|0.3555
71814455|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.436||0.2485|TWO_SIDED|95.0|-0.36|1.38|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.38|-0.36|0.2485
71814456|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.435||0.0866|TWO_SIDED|95.0|-0.11|1.63|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.63|-0.11|0.0866
71814457|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.356||0.4101|TWO_SIDED|95.0|-0.42|1.01|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||1.01|-0.42|0.4101
71814458|NCT03502616|143130748|SUPERIORITY||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.217||0.0237|TWO_SIDED|95.0|0.07|0.94|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.94|0.07|0.0237
71845992|NCT01728324|143206997|SUPERIORITY_OR_OTHER||Adjusted response rate|75.89||||0.002|TWO_SIDED|95.0|70.63|81.14|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.||The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.||81.14|70.63|0.0020
71845993|NCT01728324|143206998|SUPERIORITY_OR_OTHER||SVR12 Rates difference|6.4||||0.0532|TWO_SIDED|95.0|-1.4|14.2|||Koch's method|Adjusted for PegIFN eligibility using Koch's method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||14.2|-1.4|0.0532
71845994|NCT01728324|143206999|SUPERIORITY_OR_OTHER||SVR4 Rates difference|3.6||||0.1671|TWO_SIDED|95.0|-3.7|10.9|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||10.9|-3.7|0.1671
71677921|NCT02461524|142874364|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Percentage|100.0||||0.001|ONE_SIDED|95.0|95.8||||Based on exact binomial distribution|||"The primary effectiveness endpoint was tested against a predetermined effectiveness PG using following statistical hypotheses:~H0: q ≤ 80% vs. H1: q \> 80% where q is the proportion of subjects who have a successful aneurysm treatment in the target population of subjects treated with the Endurant Evo AAA Stent graft system and 80% is the effectiveness PG."|||95.8|0.001
71677922|NCT00765895|142874378|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||Mantel Haenszel|Stratified by clinic||||||0.86
71677923|NCT04481191|142874387|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.0|0.9||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||0.9|-4.0|< 0.001
71677924|NCT04481191|142874387|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-4.3|1.5||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use Group % - Staggered-use Group %||1.5|-4.3|< 0.001
71677925|NCT04481191|142874387|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in percentages (Concomitant-use Group - Staggered-use Group) being \> -10 percentage points (one-sided p-value \< 0.025).|Mean Difference (Final Values)|0.5|||<|0.001|TWO_SIDED|95.0|-1.6|3.0||One-sided p-value|Unstratified Miettinen & Nurminen method|||Difference indicates Concomitant-use % - Staggered-use %||3.0|-1.6|< 0.001
71677926|NCT02002533|142874467|SUPERIORITY||||||>|0.9999|||||||exact binomial test|The percentage is greater than or equal to 40%.||||||>0.9999
71677927|NCT02002533|142874468|SUPERIORITY|||||||0.735|||||||exact binomial test|||||||0.7350
71677928|NCT02002533|142874469|SUPERIORITY||Mean Difference (Final Values)|0.8075|STANDARD_ERROR_OF_MEAN|0.0845|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71677929|NCT02002533|142874470|SUPERIORITY||Mean Difference (Final Values)|-1.64|STANDARD_ERROR_OF_MEAN|1.21||0.1808|TWO_SIDED||||||ANCOVA||The estimated value is BBT minus HEAL.|||||0.1808
71677930|NCT02002533|142874471|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.73||0.14|TWO_SIDED||||||ANCOVA||Estimated value is BBT minus HEAL.|||||0.14
71677931|NCT02002533|142874472|SUPERIORITY||Mean Difference (Final Values)|0.404|STANDARD_ERROR_OF_MEAN|0.137||0.005|TWO_SIDED||||||ANCOVA|For baseline of 0.7.||||||0.005
71677932|NCT02002533|142874472|SUPERIORITY||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.045||0.092|TWO_SIDED|||||At baseline 1.3.|ANCOVA|||||||0.092
71677933|NCT02002533|142874472|SUPERIORITY||Mean Difference (Final Values)|-0.032|STANDARD_ERROR_OF_MEAN|0.053||0.556|TWO_SIDED|||||At baseline of 1.5.|ANCOVA|||||||0.556
71677934|NCT02002533|142874472|SUPERIORITY||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|||||Grouped by baseline interaction.|ANCOVA||The estimated value is grouped by baseline interaction parameter.|||||0.007
71677935|NCT02002533|142874473|SUPERIORITY|||||||0|||||||ANCOVA|||||||0.000
71677936|NCT02002533|142874474|SUPERIORITY|||||||0.295|||||||ANCOVA|||||||0.295
71677937|NCT02002533|142874475|SUPERIORITY|||||||0.573|||||||ANCOVA|||||||0.573
71845995|NCT01728324|143207000|SUPERIORITY_OR_OTHER||SVR24 Rates difference|-6.9||||0.0447|TWO_SIDED|95.0|-14.8|1.1|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.||1.1|-14.8|0.0447
71677938|NCT02002533|142874476|SUPERIORITY||Mean Difference (Final Values)|-6.502|STANDARD_ERROR_OF_MEAN|2.558||0.015|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.015
71677939|NCT02002533|142874476|SUPERIORITY||Mean Difference (Final Values)|-1.723|STANDARD_ERROR_OF_MEAN|1.007||0.094|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.094
71845996|NCT01335867|143207002|SUPERIORITY|||||||0.14|||||||Chi-squared|||||||.14
71845997|NCT01335867|143207004|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||.24
71845998|NCT01335867|143207005|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||.20
71845999|NCT01335867|143207006|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||.64
71846000|NCT03057600|143207007|SUPERIORITY|||||||0.2252|||||||exact one-sample binomial tests|||||||0.2252
71846001|NCT03057600|143207007|SUPERIORITY|||||||0.9437|||||||exact one-sample binomial tests|||||||0.9437
71846002|NCT03057600|143207007|SUPERIORITY|||||||0.5797|||||||exact one-sample binomial tests|||||||0.5797
71846003|NCT03057600|143207007|SUPERIORITY|||||||0.0243|||||||exact one-sample binomial tests|||||||0.0243
71846004|NCT01968967|143207012|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.2|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-58.3|-54.0|||MMRM|||Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-54.0|-58.3|<0.001
71897355|NCT02075255|143317173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-162.2|||<|0.001|TWO_SIDED|95.0|-220.1|-104.3|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit|Percent change|||-104.3|-220.1|<0.001
71677940|NCT02002533|142874476|SUPERIORITY||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.326||0.114|TWO_SIDED||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.|||||0.114
71677941|NCT02002533|142874476|SUPERIORITY||Mean Difference (Final Values)|0.911|STANDARD_ERROR_OF_MEAN|0.4||0.027|TWO_SIDED||||||ANCOVA||This is an arm by baseline interaction parameter.|||||0.027
71897356|NCT02075255|143317173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.4|||<|0.001|TWO_SIDED|95.0|-217.9|-100.9|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.|Percent change|||-100.9|-217.9|<0.001
71677942|NCT00722566|142874481|NON_INFERIORITY_OR_EQUIVALENCE|Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.|ORR_SQ - 0.6 ORR_IV|16.8||||0.00201|TWO_SIDED|95.0|6.1|27.1|||Farrrington and Manning|CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).||In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC - 0.60 ORRIV \<0 vs. H1: ORRSC - 0.60 ORRIV ≥0 (non-inferiority).||27.1|6.1|0.00201
71677943|NCT04984278|142874483|SUPERIORITY||Combined least mean square difference|-0.29|STANDARD_ERROR_OF_MEAN|0.092|=|0.0048|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|=0.0048
71677944|NCT01895270|142874501|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||.42
71677945|NCT01098500|142874585|SUPERIORITY_OR_OTHER||Prevalence percentage|2.2|||||TWO_SIDED|95.0|0.9|3.5|||||Prevalence percentage is the number of patients with an ALT \>=3 times ULN divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||3.5|0.9|
71677946|NCT01098500|142874586|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|6.2|||||TWO_SIDED|95.0|3.3|9.0|||||Incidence rate (IR) is the number of patients with an ALT \>=3 times ULN after initiation of TKI divided by person time contributed by all patients with normal ALT (\<1 times ULN) at baseline. IR expressed per 100 person years.|||9.0|3.3|
71677947|NCT01098500|142874587|SUPERIORITY_OR_OTHER||Prevalence percentage|0.4|||||TWO_SIDED|95.0|0.1|1.4|||||Prevalence percentage is the number of patients with Hy's Law divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).|||1.4|0.1|
71846005|NCT01968967|143207013|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.0|STANDARD_ERROR_OF_MEAN|0.76|<|0.001|TWO_SIDED|95.0|-36.5|-33.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.5|-36.5|<0.001
71846006|NCT01968967|143207013|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|95.0|-33.3|-29.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-29.8|-33.3|
71846007|NCT01968967|143207013|SUPERIORITY_OR_OTHER||LS Mean Difference|-24.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-26.6|-22.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.8|-26.6|
71846008|NCT01968967|143207014|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.8|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.9|-48.8|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.8|-52.9|<0.001
71677948|NCT01098500|142874588|SUPERIORITY_OR_OTHER||Incidence Rate (IR)|0.4|||||TWO_SIDED|95.0|0.0|2.0|||||Incidence rate (IR) is the number of patients with Hy's Law after initiation of TKI divided by person time contributed by all patients with normal ALT, AST, ALP, and BIL (\< 1 times ULN) at baseline. IR is expressed per 100 person years.|||2.0|0.0|
71677949|NCT03628339|142874607|OTHER||% Ratio of Geometric Least square Mean|101.4|||||TWO_SIDED|90.0|89.35|115.06||||||||115.06|89.35|
71846009|NCT01968967|143207014|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.1|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|95.0|-48.5|-43.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.8|-48.5|
71846010|NCT01968967|143207014|SUPERIORITY_OR_OTHER||LS Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|1.28|||TWO_SIDED|95.0|-38.6|-33.6||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.6|-38.6|
71846011|NCT01968967|143207015|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.1|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-52.1|-48.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-52.1|<0.001
71846012|NCT01968967|143207015|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.5|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|95.0|-47.9|-43.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.1|-47.9|
71677950|NCT03628339|142874608|OTHER||% Ratio of Geometric Least square Mean|101.16|||||TWO_SIDED|90.0|89.24|114.66||||||||114.66|89.24|
71677951|NCT03628339|142874609|OTHER||% Ratio of Geometric Least square Mean|103.62|||||TWO_SIDED|90.0|86.91|123.56||||||||123.56|86.91|
71677952|NCT04507256|142874662|OTHER|Bioavailability|Ratio of geometric mean AUCinf|68.69|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895.|Bioavailability of AZD8895 at the end of study (Day 361)||||
71677953|NCT04507256|142874662|OTHER|Bioavailability|Ratio of geometric mean AUCinf|65.02|||||||||||||The bioavailability of AZD7442 Dose 1 administered by IM was, calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD1061.|Bioavailability of AZD1061 at the end of study (Day 361)||||
71677954|NCT03330262|142874687|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71677955|NCT03330262|142874688|OTHER|Ho: mean change = 0||||||0.006|||||||Mixed Models Analysis|||||||0.006
71677956|NCT03330262|142874688|OTHER|Ho: mean change = 0||||||0.869|||||||Mixed Models Analysis|||||||0.869
71677957|NCT03330262|142874689|SUPERIORITY|||||||0.448|||||||Mixed Models Analysis|||||||0.448
71846013|NCT01968967|143207015|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-38.5|-33.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-33.3|-38.5|
71846014|NCT01968967|143207016|SUPERIORITY_OR_OTHER||LS Mean Difference|-57.7|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-60.2|-55.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-55.2|-60.2|<0.001
71846015|NCT01968967|143207016|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.1|STANDARD_ERROR_OF_MEAN|1.55|||TWO_SIDED|95.0|-56.1|-50.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-50.0|-56.1|
71846016|NCT01968967|143207016|SUPERIORITY_OR_OTHER||LS Mean Difference|-42.8|STANDARD_ERROR_OF_MEAN|1.7|||TWO_SIDED|95.0|-46.2|-39.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-39.5|-46.2|
71846017|NCT01968967|143207017|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.8|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|-55.9|-47.7|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-47.7|-55.9|<0.001
71846018|NCT01968967|143207017|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-49.1|-38.8||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-38.8|-49.1|
71846019|NCT01968967|143207017|SUPERIORITY_OR_OTHER||LS Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-40.2|-29.0||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-29.0|-40.2|
71846020|NCT01968967|143207018|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-34.4|-22.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-22.5|-34.4|<0.001
71846021|NCT01968967|143207018|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-40.6|-21.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-21.5|-40.6|
71846022|NCT01968967|143207018|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.3|STANDARD_ERROR_OF_MEAN|5.89|||TWO_SIDED|95.0|-36.8|-13.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.7|-36.8|
71846023|NCT01968967|143207019|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|4.5|7.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||7.0|4.5|<0.001
71846024|NCT01968967|143207019|SUPERIORITY_OR_OTHER||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|4.2|6.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.8|4.2|
71846025|NCT01968967|143207019|SUPERIORITY_OR_OTHER||LS Mean Difference|5.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|3.7|6.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||6.7|3.7|
71846026|NCT01968967|143207020|SUPERIORITY_OR_OTHER||LS Mean Difference|-50.7|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|95.0|-53.3|-48.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-48.0|-53.3|
71677958|NCT03330262|142874690|OTHER|This test evaluated whether the change in ABC was significant for the BALCAP condition##. Ho: mean = 0||||||0.273|||||||Mixed Models Analysis|||||||0.273
71677959|NCT03330262|142874690|OTHER|This test evaluated if the change in ABC score was significant for the control group.||||||0.796|||||||Mixed Models Analysis|||||||0.796
71677960|NCT03330262|142874691|OTHER|Ho: Mean change in score = 0||||||0.189|||||||Mixed Models Analysis|||||||0.189
71677961|NCT03330262|142874691|OTHER|Ho: mean change = 0||||||0.713|||||||Mixed Models Analysis|||||||0.713
71897357|NCT03503773|143317179|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.2682|TWO_SIDED|95.0|-4.8|1.7|||ANCOVA||There was no formal hypothesis testing conducted in the study. 95% CIs are intended to be descriptive in nature only|The null hypothesis to be tested is that there is no difference in the change in 24 hour mean SBP between treatment and sham control. The Type I error rate for rejecting the null hypothesis will be set at an alpha level of 0.05.||1.7|-4.8|0.2682
71897358|NCT03503773|143317180|SUPERIORITY|||||||0.6964|||||||ANCOVA|||Difference between treatment arms||||0.6964
71897359|NCT03503773|143317181|SUPERIORITY|||||||0.0775|||||||ANCOVA|||Between group difference||||0.0775
71897360|NCT03503773|143317183|SUPERIORITY|||||||0.4734|||||||ANCOVA|||Between group difference||||0.4734
71897361|NCT03503773|143317185|SUPERIORITY|||||||0.0341|||||||ANCOVA|||||||0.0341
71897362|NCT03503773|143317187|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.573|TWO_SIDED|95.0|-0.132|0.073|||Fisher Exact|||||0.073|-0.132|0.573
71897363|NCT01208181|143317231|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.29||||0.004|TWO_SIDED|95.0|-0.49|-0.09|||Tukey-Ciminera-Heysetrend test|||||-0.09|-0.49|0.004
71677962|NCT01647516|142874692|SUPERIORITY||Odds Ratio (OR)|3.262||||0.0482|TWO_SIDED|95.0|0.969|10.984|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||10.984|0.969|0.0482
71897364|NCT01208181|143317231|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-0.27||||0.034|TWO_SIDED|95.0|-0.48|-0.06|||Tukey-Ciminera-Heysetrend test|||||-0.06|-0.48|0.034
71897365|NCT01208181|143317232|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-7.99|||<|0.001|TWO_SIDED|95.0|-11.85|-4.13|||Tukey-Ciminera-Heyse trend test|||||-4.13|-11.85|<0.001
71897366|NCT01208181|143317232|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-10.7|||<|0.001|TWO_SIDED|95.0|-14.74|-6.66|||Tukey-Ciminera-Heyse trend test|||||-6.66|-14.74|<0.001
71897367|NCT01208181|143317233|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|0.02||||0.73|TWO_SIDED|95.0|-0.1|0.14|||Tukey-Ciminera-Heysetrend test|||||0.14|-0.10|0.730
71897368|NCT01208181|143317234|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares mean|-2.71||||0.019|TWO_SIDED|95.0|-4.98|-0.45|||Tukey-Ciminera-Heyse trend test|||||-0.45|-4.98|0.019
71897369|NCT01208181|143317235|SUPERIORITY_OR_OTHER_LEGACY||Difference in the least squares mean|1.61||||0.327|TWO_SIDED|80.0|-0.49|3.71|||covariance model|||||3.71|-0.49|0.327
71897370|NCT03694522|143317275|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0727|TWO_SIDED|95.0|0.44|1.04|||Stratified log-rank test|Adjusted for randomization stratification factors of geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||1.04|0.44|0.0727
71897371|NCT03694522|143317276|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0268|TWO_SIDED|95.0|0.35|0.95|||Stratified log-rank test|Adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.95|0.35|0.0268
71897372|NCT03694522|143317277|SUPERIORITY||Difference|13.1||||0.106|TWO_SIDED|95.0|-2.8|29.0|||Cochran-Mantel-Haenszel|P-value was calculated based on stratum-adjusted Cochran-Mantel-Haenszel (CMH) proportions||||29.0|-2.8|0.1060
71897373|NCT03694522|143317279|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.94|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model, adjusted for randomization stratification factors, including geographic region and administration of mFOLFOX6 single dose prior to randomization.|||0.94|0.38|
71897374|NCT01748760|143317280|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Chi-squared|||||||.87
71897375|NCT01164501|143317281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.62|-0.39||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.39|-0.62|<0.0001
71897376|NCT01164501|143317282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.72|-0.32||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.32|-0.72|<0.0001
71897377|NCT01164501|143317282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.49||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.49|-0.88|<0.0001
71897378|NCT01164501|143317283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.28|-0.56|<0.0001
71897379|NCT01751646|143317296|OTHER|||||||0.1166||||||P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo|Wilcoxon (Mann-Whitney)|||||||0.1166
71897380|NCT01751646|143317298|OTHER|||||||0.8383|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.8383
71897381|NCT01751646|143317301|OTHER|||||||0.1378|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1378
71897382|NCT01751646|143317303|OTHER|||||||0.4686|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4686
71897383|NCT01751646|143317305|OTHER|||||||0.7601|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.7601
71897384|NCT01751646|143317307|OTHER|||||||0.3978|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.3978
71897385|NCT01751646|143317309|OTHER|||||||0.1187|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.1187
71897386|NCT01751646|143317312|OTHER|||||||0.5098|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.5098
71897387|NCT01751646|143317313|OTHER|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2550
71897388|NCT01751646|143317314|OTHER|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.6499
71897389|NCT01751646|143317315|OTHER|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.2348
71897390|NCT01751646|143317318|OTHER|||||||0.2648|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.2648
71897391|NCT01751646|143317321|OTHER|||||||0.3728|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3728
71897392|NCT01751646|143317324|OTHER|||||||0.7825|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7825
71897393|NCT01751646|143317327|OTHER|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1950
71897394|NCT01751646|143317330|OTHER|||||||0.7127|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.7127
71897395|NCT01751646|143317333|OTHER|||||||0.4676|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4676
71897396|NCT01751646|143317336|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0210
71897397|NCT01751646|143317339|OTHER|||||||0.0144|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0144
71897398|NCT01751646|143317342|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||< 0.0001
71897399|NCT01751646|143317345|OTHER|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.0814
71897400|NCT01751646|143317348|OTHER|||||||0.4808|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4808
71897401|NCT01751646|143317351|OTHER|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.3870
71897402|NCT01751646|143317354|OTHER|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)||||0.4290
71897403|NCT01751646|143317355|OTHER|||||||0.9186|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.9186
71897404|NCT01751646|143317356|OTHER|||||||0.4016|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.4016
71897405|NCT01751646|143317357|OTHER|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.5810
71897406|NCT01751646|143317358|OTHER|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)||||0.1570
71897407|NCT01751646|143317364|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to week 48||||<0.0001
71897408|NCT01751646|143317364|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to Week 48||||<0.0001
71897409|NCT01751646|143317367|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
71897410|NCT01751646|143317367|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline||||< 0.0001
71897411|NCT02613572|143317372|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71897412|NCT02613572|143317373|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
71897413|NCT02613572|143317374|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71897414|NCT02613572|143317375|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.30
71897415|NCT02613572|143317376|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||||||0.14
71897416|NCT02613572|143317377|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|||||||0.69
71897417|NCT01748695|143317394|SUPERIORITY_OR_OTHER|||||||0.834||||||Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.|Regression, Linear|||||||0.834
71897418|NCT01707147|143317408|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_DEVIATION|1.5|<|0.0001|TWO_SIDED|95.0|-0.83|-0.71|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-0.71|-0.83|<0.0001
71897419|NCT01707147|143317411|OTHER||Mean Difference (Final Values)|-18.05|STANDARD_DEVIATION|61.84|<|0.0001|TWO_SIDED|95.0|-20.98|-15.12|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.|||-15.12|-20.98|<0.0001
71897420|NCT01040832|143317418|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.793|TWO_SIDED|95.0|0.7|1.6|||Stratified log rank|||||1.6|0.7|0.793
71897421|NCT01040832|143317419|SUPERIORITY_OR_OTHER||||||>|0.999||95.0|||||Cochran-Mantel-Haenszel|||||||>0.999
71897422|NCT01040832|143317420|SUPERIORITY_OR_OTHER|||||||0.557||95.0|||||Cochran-Mantel-Haenszel|||||||0.557
71897423|NCT01592851|143317427|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.03|-0.63||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.63|-1.03|<0.0001
71897424|NCT01592851|143317428|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26||||0.0006|TWO_SIDED|95.0|-0.41|-0.12||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.12|-0.41|0.0006
71897425|NCT01592851|143317429|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.63|-0.28||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.28|-0.63|<0.0001
71897426|NCT01592851|143317430|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|19.42|||<|0.0001|TWO_SIDED|95.0|13.7|25.15||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||25.15|13.70|<0.0001
71897427|NCT01592851|143317431|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.84||||0.0021|TWO_SIDED|95.0|2.54|11.13||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||11.13|2.54|0.0021
71897428|NCT01592851|143317432|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|3.87||||0.007|TWO_SIDED|95.0|1.08|6.65||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||6.65|1.08|0.0070
71897429|NCT00909090|143317463|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71897430|NCT00909090|143317464|SUPERIORITY|||||||0.21|||||||Regression, Linear|||Analysis compared mean differences between placebo and intervention at the 12-month time point.||||0.21
71897431|NCT00909090|143317465|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||Analysis compared mean change from baseline to 12-month time points.||||0.01
71897432|NCT00909090|143317466|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||analysis conducted on mean change over one year, between groups||||0.02
71897433|NCT00858702|143317470|SUPERIORITY_OR_OTHER|||||||0.0158||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0158
71897434|NCT00858702|143317471|SUPERIORITY_OR_OTHER|||||||0.0566||95.0||||No consideration for multiplicity|Fisher Exact|||||||0.0566
71897435|NCT00858702|143317472|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No consideration for multiplicity|Fisher Exact|||||||<0.001
71897436|NCT00062738|143317474|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.7|||<|0.05|TWO_SIDED|95.0|0.8|15.9|||Fisher Exact|||For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.||15.9|0.8|<.05
71897437|NCT01214434|143317480|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||||||>0.05
71897438|NCT01214434|143317482|SUPERIORITY_OR_OTHER||||||=|0.03||95.0|||||t-test, 2 sided|||||||=0.03
71897439|NCT01214434|143317483|SUPERIORITY_OR_OTHER||||||=|0.6||95.0|||||t-test, 2 sided|||||||=0.6
71897440|NCT01214434|143317484|SUPERIORITY_OR_OTHER||||||=|0.24||95.0|||||t-test, 2 sided|||||||=.24
71897441|NCT01214434|143317485|SUPERIORITY_OR_OTHER||||||=|0.8||95.0|||||t-test, 2 sided|||||||=0.8
71897442|NCT03494725|143317525|SUPERIORITY|||||||0.757||||||Outcome was subjected to transformation to meet model assumptions. The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Linear mixed model||The sample size was computed for a repeated measurement ANOVA with two groups and seven repeated measurements (power=0.85, α=0.05, f=0.1). The calculation resulted in a group size of 56 participants each, which was rounded up to 60 participants per treatment group to account for attrition.||||0.757
71897443|NCT00514449|143317566|OTHER||number of voxels in a cluster|2037.0||||0.004|TWO_SIDED|||||p value is adjusted for multiple comparisons|ANCOVA||Time by treatment group interaction term|||||0.004
71897444|NCT00149825|143317578|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Chi-squared|This is a one-tailed test||We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression||||.13
71897445|NCT00149825|143317579|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.||||.05
71897446|NCT00942708|143317581|OTHER|Single group evaluation of change in PVR between 12 weeks and baseline (T-test for one group, 2-sided, p\<0.05 considered significant)||||||0.09|||||||t-test, 1 sided|||||||0.09
71897447|NCT02760407|143317668|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|97.5|0.183|0.352|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q4w treatment group at Week 12 was expected to be at least 50% resulting in an expected difference in ACR20 response rates of 25 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.352|0.183|<0.0001
71897448|NCT02760407|143317668|SUPERIORITY||Risk Difference (RD)|0.258|||<|0.0001|TWO_SIDED|97.5|0.171|0.341|||Chi-squared|2x2 chi-square test||The OKZ ACR20 response rate for the 64 mg q2w treatment group at Week 12 was expected to be at least 55%, resulting in an expected difference in ACR20 response rate of 30 percentage points between the respective OKZ treatment group and placebo. Sample size yield 100% disjunctive power for testing the primary hypothesis||0.341|0.171|<0.0001
71897449|NCT02760407|143317669|SUPERIORITY||Risk Difference (RD)|0.224|||<|0.0001|TWO_SIDED|95.0|0.148|0.298|||Chi-squared|2x2 chi-square test||The ACR20 response rate for adalimumab was expected to be at least 52.5% at Week 12.||0.298|0.148|<0.0001
71897450|NCT02760407|143317669|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.045|||||TWO_SIDED|97.5|-0.022|0.112||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.112|-0.022|
71846027|NCT01968967|143207020|SUPERIORITY_OR_OTHER||LS Mean Difference|-40.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-43.5|-37.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-37.8|-43.5|
71846028|NCT01968967|143207021|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
71846029|NCT01968967|143207021|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
71846030|NCT01968967|143207021|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
71846031|NCT01968967|143207022|SUPERIORITY_OR_OTHER||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|2.4|4.3||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.3|2.4|
71846032|NCT01968967|143207022|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|2.5|4.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.5|2.5|
71846033|NCT01968967|143207022|SUPERIORITY_OR_OTHER||LS Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|2.7|4.9||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||4.9|2.7|
71846034|NCT01968967|143207023|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.9|1.4||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||1.4|-0.9|
71846035|NCT01968967|143207023|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-0.1|2.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.3|-0.1|
71846036|NCT01968967|143207023|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|0.3|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||2.7|0.3|
71846037|NCT01968967|143207024|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.6|STANDARD_ERROR_OF_MEAN|1.73|||TWO_SIDED|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-13.2|-20.0|
71846038|NCT01968967|143207024|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-12.6|-20.7|
71846039|NCT01968967|143207024|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.8|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.0|-16.5|
71846040|NCT01968967|143207025|SUPERIORITY_OR_OTHER||LS Mean Difference|-60.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-63.1|-57.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.6|-63.1|
71897451|NCT02760407|143317669|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined non-inferiority margin of -12%.|Risk Difference (RD)|0.034|||||TWO_SIDED|97.5|-0.035|0.102||||||A noninferiority margin of 12% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.102|-0.035|
71814459|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.107||0.0043|TWO_SIDED|95.0|0.1|0.52|||Mixed Models Analysis|||Week 2: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|0.10|0.0043
71814460|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.121||0.0072|TWO_SIDED|95.0|0.09|0.56|||Mixed Models Analysis|||Week 4: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.56|0.09|0.0072
71814461|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.146||0.1101|TWO_SIDED|95.0|-0.05|0.52|||Mixed Models Analysis|||Week 8: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.52|-0.05|0.1101
71814462|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.13||0.0147|TWO_SIDED|95.0|0.06|0.58|||Mixed Models Analysis|||Week 12: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.58|0.06|0.0147
71814463|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.162||0.2032|TWO_SIDED|95.0|-0.11|0.53|||Mixed Models Analysis|||Week 16: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.53|-0.11|0.2032
71814464|NCT03502616|143130749|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.168||0.9345|TWO_SIDED|95.0|-0.34|0.32|||Mixed Models Analysis|||Week 24: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.32|-0.34|0.9345
71814465|NCT03502616|143130749|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.187||0.5968|TWO_SIDED|95.0|-0.47|0.27|||Mixed Models Analysis|||Week 32: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.27|-0.47|0.5968
71814466|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.166||0.7047|TWO_SIDED|95.0|-0.26|0.39|||Mixed Models Analysis|||Week 40: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.39|-0.26|0.7047
71814467|NCT03502616|143130749|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.157||0.807|TWO_SIDED|95.0|-0.27|0.35|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.35|-0.27|0.8070
71814468|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.055||0.003|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 16, Mobility: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.06|-0.28|0.0030
71814469|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.055||0.897|TWO_SIDED|95.0|-0.11|0.1|||ANCOVA|||Week 16, Self-Care: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.10|-0.11|0.8970
71814470|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.058||0.1437|TWO_SIDED|95.0|-0.2|0.03|||ANCOVA|||Week 16, Usual Activities: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.03|-0.20|0.1437
71897452|NCT02760407|143317670|SUPERIORITY||Risk Difference (RD)|0.332|||<|0.0001|TWO_SIDED|97.5|0.257|0.397|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 22% in the 64 mg q4w OKZ group, resulting in an expected difference of 12 percentage points between respective OKZ group and placebo.||0.397|0.257|<0.0001
71897453|NCT02760407|143317670|SUPERIORITY||Risk Difference (RD)|0.325|||<|0.0001|TWO_SIDED|97.5|0.25|0.391|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity (based on DAS28 \[CRP\] \<3.2) response rate at Week 12 is estimated to be 10% in the placebo group and 30% in the 64 mg q2w OKZ group, resulting in an expected difference of 20 percentage points between respective OKZ group and placebo.||0.391|0.250|<0.0001
71897454|NCT02760407|143317671|SUPERIORITY||Risk Difference (RD)|0.256|||<|0.0001|TWO_SIDED|95.0|0.191|0.313|||Chi-squared|2x2 chi-square test||The DAS28 low disease activity response rate for adalimumab was expected to be at least 27% at Week 12.||0.313|0.191|<0.0001
71814471|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|-0.27|-0.09|||ANCOVA|||Week 16, Pain/Discomfort: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-0.09|-0.27|<0.0001
71814472|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.061||0.8445|TWO_SIDED|95.0|-0.13|0.11|||ANCOVA|||Week 16, Anxiety/Depression: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||0.11|-0.13|0.8445
71814473|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.064||0.3473|TWO_SIDED|95.0|-0.19|0.07|||Mixed Models Analysis|||Week 48, Mobility: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.07|-0.19|0.3473
71677963|NCT01647516|142874692|SUPERIORITY||Odds Ratio (OR)|2.5||||0.1422|TWO_SIDED|95.0|0.722|8.661|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||8.661|0.722|0.1422
71677964|NCT01647516|142874693|SUPERIORITY||Odds Ratio (OR)|2.158||||0.0207|TWO_SIDED|95.0|1.093|4.263|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||4.263|1.093|0.0207
71677965|NCT01647516|142874693|SUPERIORITY||Odds Ratio (OR)|1.947||||0.0648|TWO_SIDED|95.0|0.961|3.946|||Cochran-Mantel-Haenszel|Stratified by prior anti-tumor necrosing factor (anti-TNF) therapy experience, (yes or no).||||3.946|0.961|0.0648
71677966|NCT01647516|142874694|SUPERIORITY|||||||0.0042|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.0042
71677967|NCT01647516|142874694|SUPERIORITY|||||||0.1415|||||||ANCOVA|The analysis of covariance model, adjusting for baseline Mayo score and prior anti-TNF (yes or no).||||||0.1415
71677968|NCT01647516|142874695|SUPERIORITY||Odds Ratio (OR)|3.861||||0.0023|TWO_SIDED|95.0|1.572|9.484|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||9.484|1.572|0.0023
71677969|NCT01647516|142874695|SUPERIORITY||Odds Ratio (OR)|2.647||||0.0348|TWO_SIDED|95.0|1.058|6.621|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||6.621|1.058|0.0348
71677970|NCT01647516|142874696|SUPERIORITY||Odds Ratio (OR)|4.332||||0.0108|TWO_SIDED|95.0|1.323|14.186|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||14.186|1.323|0.0108
71846041|NCT01968967|143207026|SUPERIORITY_OR_OTHER||LS Mean Difference|-62.8|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-68.3|-57.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction and geographical region. An unstructured variance covariance matrix was used.||-57.3|-68.3|
71846042|NCT01968967|143207027|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.0|STANDARD_ERROR_OF_MEAN|1.27|||TWO_SIDED|95.0|-63.5|-58.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-58.5|-63.5|
71897455|NCT02760407|143317671|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.076|||||TWO_SIDED|97.5|0.004|0.147||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.147|0.004|
71677971|NCT01647516|142874696|SUPERIORITY||Odds Ratio (OR)|5.443||||0.0021|TWO_SIDED|95.0|1.706|17.365|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||17.365|1.706|0.0021
71677972|NCT01647516|142874697|SUPERIORITY|Stratified by prior anti-TNF therapy experience, (yes or no).|Odds Ratio (OR)|4.03||||0.0002|TWO_SIDED|95.0|1.871|8.678|||Cochran-Mantel-Haenszel|||||8.678|1.871|0.0002
71677973|NCT01647516|142874697|SUPERIORITY||Odds Ratio (OR)|2.154||||0.0571|TWO_SIDED|95.0|0.974|4.763|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||4.763|0.974|0.0571
71677974|NCT01647516|142874698|SUPERIORITY||Odds Ratio (OR)|3.557||||0.0046|TWO_SIDED|95.0|1.444|8.762|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.762|1.444|0.0046
71677975|NCT01647516|142874698|SUPERIORITY||Odds Ratio (OR)|3.428||||0.0064|TWO_SIDED|95.0|1.384|8.494|||Cochran-Mantel-Haenszel|Stratified by prior anti-TNF therapy experience, (yes or no).||||8.494|1.384|0.0064
71677976|NCT03886519|142874724|SUPERIORITY||Odds Ratio (OR)|0.73||||0.07|TWO_SIDED|95.0|0.52|1.03||The a priori threshold for statistical significance is \<0.05.|Regression, Logistic|Adjusted for correlation between 2 eyes of a participant and baseline trichiasis severity.||||1.03|0.52|0.07
71846043|NCT01968967|143207028|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.7|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-66.6|-60.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-60.9|-66.6|
71677977|NCT04964544|142874738|OTHER||Percentage|90.7|||||TWO_SIDED|95.0|88.9|92.3|||||Proportion of participants|Proportion of participants with overall correct initial TASS assessment, with mitigations, worst case imputation (Self-Selection Population)||92.3|88.9|
71677978|NCT04964544|142874739|OTHER||Percentage|98.1|||||TWO_SIDED|95.0|97.1|98.8|||||Proportion of participants|Proportion of participants with overall correct final TASS assessment, with mitigations, worst case imputation (Per Protocol Population)||98.8|97.1|
71677979|NCT04964544|142874740|OTHER||Mean percent change from paseline|-35.48|||||TWO_SIDED|95.0|-36.63|-34.33||||||||-34.33|-36.63|
71897456|NCT02760407|143317671|NON_INFERIORITY|Non-Inferiority for each OKZ dosing regimen versus Adalimumab is achieved if the lower limit of the 97.5% confidence interval is greater than the protocol defined noninferiority margin of -7.5%.|Risk Difference (RD)|0.069|||||TWO_SIDED|97.5|-0.003|0.141||||||A noninferiority margin of 7.5% was used for the comparison between OKZ and adalimumab with respect to this endpoint.||0.141|-0.003|
71897457|NCT02760407|143317672|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.29|-0.09|||ANCOVA|||||-0.09|-0.29|<0.0001
71677980|NCT01154088|142874762|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|5.42|||||TWO_SIDED|95.0|-1.41|12.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||12.25|-1.41|
71688676|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|90.0|0.11|0.18|||t-test, 2 sided|||FEV1 Day 1 (0.25 hrs post-dose)||0.18|0.11|<0.0001
71897458|NCT02760407|143317672|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|97.5|-0.33|-0.12|||ANCOVA|||||-0.12|-0.33|<0.0001
71897459|NCT02760407|143317672|OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|95.0|-0.28|-0.1||||||||-0.10|-0.28|
71897460|NCT02760407|143317673|SUPERIORITY||Risk Difference (RD)|0.275|||<|0.0001|TWO_SIDED|97.5|0.192|0.349|||Chi-squared|2x2 chi-square test||||0.349|0.192|<0.0001
71897461|NCT02760407|143317673|SUPERIORITY||Risk Difference (RD)|0.278|||<|0.0001|TWO_SIDED|97.5|0.195|0.353|||Chi-squared|2x2 chi-square test||||0.353|0.195|<0.0001
71897462|NCT02760407|143317673|OTHER||Risk Difference (RD)|0.237|||||TWO_SIDED|95.0|0.165|0.303||||||||0.303|0.165|
71897463|NCT02760407|143317674|SUPERIORITY||Risk Difference (RD)|0.08||||0.0003|TWO_SIDED|97.5|0.031|0.123|||Chi-squared|2x2 chi-square test||||0.123|0.031|0.0003
71897464|NCT02760407|143317674|SUPERIORITY||Risk Difference (RD)|0.069||||0.001|TWO_SIDED|97.5|0.02|0.111|||Chi-squared|2x2 chi-square test||||0.111|0.020|0.001
71897465|NCT02760407|143317674|OTHER||Risk Difference (RD)|0.089|||||TWO_SIDED|95.0|0.046|0.127||||||||0.127|0.046|
71897466|NCT03245814|143317687|SUPERIORITY||Odds Ratio (OR)|0.22|||<|0.001|TWO_SIDED|95.0|0.12|0.42|||Ordinal cumulative probability model|Covariates included baseline score \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.42|0.12|<.001
71897467|NCT03245814|143317688|SUPERIORITY||Odds Ratio (OR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.40|0.11|<.001
71897468|NCT03245814|143317689|SUPERIORITY||Odds Ratio (OR)|0.45||||0.02|TWO_SIDED|95.0|0.23|0.86|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.86|0.23|.02
71897469|NCT03245814|143317690|SUPERIORITY||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.13|0.5|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.50|0.13|<.001
71897470|NCT03245814|143317691|SUPERIORITY||Odds Ratio (OR)|0.34||||0.001|TWO_SIDED|95.0|0.18|0.64|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.64|0.18|.001
71897471|NCT03245814|143317692|SUPERIORITY||Odds Ratio (OR)|2.83||||0.003|TWO_SIDED|95.0|1.47|5.45|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||5.45|1.47|.003
71897472|NCT03245814|143317693|SUPERIORITY||Odds Ratio (OR)|0.24|||<|0.001|TWO_SIDED|95.0|0.12|0.48|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.48|0.12|<.001
71897473|NCT03245814|143317694|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|2.0|7.38|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.38|2.00|<.001
71897474|NCT03245814|143317695|SUPERIORITY||Odds Ratio (OR)|4.49|||<|0.001|TWO_SIDED|95.0|2.28|8.83|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||8.83|2.28|<.001
71897475|NCT03245814|143317696|SUPERIORITY||Odds Ratio (OR)|3.73|||<|0.001|TWO_SIDED|95.0|1.88|7.4|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||7.40|1.88|<.001
71897476|NCT03245814|143317697|SUPERIORITY||Odds Ratio (OR)|2.33||||0.02|TWO_SIDED|95.0|1.22|4.47|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||4.47|1.22|.02
71897477|NCT03245814|143317698|SUPERIORITY||Odds Ratio (OR)|0.39||||0.009|TWO_SIDED|95.0|0.2|0.75|||Ordinal cumulative probability model|Covariates included baseline scores \& demographic/clinical characteristics. Multiple imputation was used to account for uncertainty (missingness).||||0.75|0.20|.009
71897478|NCT03245814|143317699|SUPERIORITY||Slope|0.42|STANDARD_ERROR_OF_MEAN|0.14||0.002|TWO_SIDED||||||Mixed Models Analysis|Mixed effects regression models to account for repeated measures (multiple assessments per day) within individuals.||||||0.002
71897479|NCT02522377|143317707|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|3.28||0.72|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.72
71897480|NCT02522377|143317708|SUPERIORITY|Superiority test based upon group differences pooled across infusions in mixed effect model|Mean Difference (Final Values)|1.98|STANDARD_ERROR_OF_MEAN|6.4||0.77|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=7.836.|Midazolam - Ketamine Infusions|||||0.77
71897481|NCT02522377|143317709|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.4|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.40
71897482|NCT02522377|143317710|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.78|STANDARD_ERROR_OF_MEAN|0.54||0.009|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.3634.|Midazolam - Ketamine Infusions|||||0.009
71897483|NCT02522377|143317711|SUPERIORITY|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|3.72|STANDARD_ERROR_OF_MEAN|3.71||0.34|TWO_SIDED||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions|||||0.34
71897484|NCT02522377|143317712|SUPERIORITY||Odds Ratio (OR)|0.36||||0.58|TWO_SIDED|95.0|0.01|7.2|||Fisher Exact||Odds Ratio of Midazolam (numerator) to Ketamine Infusions (denominator)|||7.20|0.01|0.58
71897485|NCT01158950|143317713|SUPERIORITY|||||||0.032||||||The threshold for statistical significance was set to p \< 0.05.|Fisher transformation|||The comparison group represents the difference in ICR and the baseline impulsiveness scale.||||0.032
71897486|NCT01158950|143317714|SUPERIORITY||||||<|0.05||||||The threshold is set to p \< 0.05, corrected for multiple comparisons.|Fisher transformation|Statistical tests are computed across multiple subregions (voxels) within each area. Thus, the correlation coefficient above is a summary score.||||||< 0.05
71897487|NCT02428140|143317749|SUPERIORITY||Risk Ratio (RR)|3.29||||0.003|TWO_SIDED|95.0|1.45|7.42|||t-test, 2 sided|||||7.42|1.45|0.003
71897488|NCT02428140|143317750|SUPERIORITY||Risk Difference (RD)|10.7||||0.005|TWO_SIDED|95.0|3.4|17.9|||t-test, 2 sided|||||17.9|3.4|.005
71897489|NCT02428140|143317751|SUPERIORITY||Risk Difference (RD)|2.7||||0.28|TWO_SIDED|95.0|-1.0|6.3|||t-test, 2 sided|||||6.3|-1.0|0.28
71897490|NCT02428140|143317753|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
71897491|NCT02428140|143317754|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-3.2|3.2||||||||3.2|-3.2|
71897492|NCT01422304|143317783|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.38|1.29|||Cochran-Mantel-Haenszel||Relative risk is Sugammadex versus Usual Care|Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance \< or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin \[LMWH\], including unfractionated heparin \[UFH\], or not including either LMWH or UFH)||1.29|0.38|
71897493|NCT01422304|143317784|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR) (%)|5.5|||||TWO_SIDED|95.0|3.7|7.3|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||7.3|3.7|
71897494|NCT01422304|143317784|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9||||||95.0|-0.9|2.8|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline aPTT value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.8|-0.9|
71897495|NCT01422304|143317785|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|3.0|||||TWO_SIDED|95.0|1.3|4.7|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||4.7|1.3|
71897496|NCT01422304|143317785|SUPERIORITY_OR_OTHER_LEGACY||GMR (%)|0.9|||||TWO_SIDED|95.0|-1.0|2.9|||Constrained Longitudinal Data Analysis|Model included those in APaT population with any baseline or post baseline PT(INR) value in 10 or 60 minute window (Sugammadex, Usual Care N=567, 548)|Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = \[GMR - 1\]\*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance \< or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.||2.9|-1.0|
71897497|NCT01422304|143317786|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.6|||||TWO_SIDED|95.0|-3.0|1.8|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.8|-3.0|
71897498|NCT01422304|143317787|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.4|||||TWO_SIDED|95.0|-3.4|0.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||0.5|-3.4|
71897499|NCT01422304|143317788|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-0.9|||||TWO_SIDED|95.0|-3.1|1.2|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.2|-3.1|
71897500|NCT01422304|143317789|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|0.3|||||TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||1.5|-0.7|
71897501|NCT01422304|143317791|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-45.0|30.5|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.||30.5|-45.0|
71897502|NCT01422304|143317792|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-2.7|||||TWO_SIDED|95.0|-7.4|2.0|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site|Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site||2.0|-7.4|
71814474|NCT03502616|143130750|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.059||0.9834|TWO_SIDED|95.0|-0.12|0.12|||Mixed Models Analysis|||Week 48, Self-Care: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.12|-0.12|0.9834
71814475|NCT03502616|143130750|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.066||0.7364|TWO_SIDED|95.0|-0.11|0.15|||Mixed Models Analysis|||Week 48, Usual Activities: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.15|-0.11|0.7364
71814476|NCT03502616|143130750|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8075|TWO_SIDED|95.0|-0.13|0.1|||Mixed Models Analysis|||Week 48, Pain/Discomfort: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.10|-0.13|0.8075
71814477|NCT03502616|143130750|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.067||0.5461|TWO_SIDED|95.0|-0.09|0.17|||Mixed Models Analysis|||Week 48, Anxiety/Depression: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||0.17|-0.09|0.5461
71814478|NCT03502616|143130751|SUPERIORITY||LS mean difference|10.11|STANDARD_ERROR_OF_MEAN|2.331|<|0.0001|TWO_SIDED|95.0|5.52|14.7|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||14.70|5.52|<0.0001
71814479|NCT03502616|143130751|SUPERIORITY||LS mean difference|2.63|STANDARD_ERROR_OF_MEAN|2.337||0.2608|TWO_SIDED|95.0|-1.97|7.24|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||7.24|-1.97|0.2608
71814480|NCT03502616|143130752|SUPERIORITY||LS mean difference|-4.53|STANDARD_ERROR_OF_MEAN|3.35||0.1784|TWO_SIDED|95.0|-11.15|2.09|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||2.09|-11.15|0.1784
71814481|NCT03502616|143130752|SUPERIORITY||LS mean difference|-2.31|STANDARD_ERROR_OF_MEAN|2.54||0.3651|TWO_SIDED|95.0|-7.34|2.72|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.72|-7.34|0.3651
71814482|NCT03502616|143130753|SUPERIORITY||LS mean difference|-12.89|STANDARD_ERROR_OF_MEAN|2.884|<|0.0001|TWO_SIDED|95.0|-18.59|-7.19|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.19|-18.59|<0.0001
71814483|NCT03502616|143130753|SUPERIORITY||LS mean difference|-2.36|STANDARD_ERROR_OF_MEAN|3.318||0.4788|TWO_SIDED|95.0|-8.92|4.21|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||4.21|-8.92|0.4788
71814484|NCT03502616|143130754|SUPERIORITY||LS mean difference|-13.85|STANDARD_ERROR_OF_MEAN|3.202|<|0.0001|TWO_SIDED|95.0|-20.18|-7.52|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-7.52|-20.18|<0.0001
71846044|NCT01968967|143207029|SUPERIORITY_OR_OTHER||LS Mean Difference|-66.4|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-69.3|-63.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-63.6|-69.3|
71846045|NCT01968967|143207030|SUPERIORITY_OR_OTHER||LS Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|95.0|-47.7|-43.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-43.9|-47.7|
71846046|NCT01968967|143207031|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-11.8|-9.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-9.3|-11.8|
71814485|NCT03502616|143130754|SUPERIORITY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|3.613||0.2244|TWO_SIDED|95.0|-11.56|2.74|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||2.74|-11.56|0.2244
71897503|NCT01422304|143317793|SUPERIORITY_OR_OTHER_LEGACY||GMR|1.1|||||TWO_SIDED|95.0|0.98|1.24|||Generalized Linear Model||GMR is Sugammadex versus Usual Care|Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.||1.24|0.98|
71897504|NCT01422304|143317794|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-0.4|3.1|||Generalized Linear Model||Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.||3.1|-0.4|
71897505|NCT01422304|143317795|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (%)|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||Miettinen and Nurminen||Risk difference (%) = Sugammadex incidence - Usual Care incidence|||3.1|-6.3|
71897506|NCT04799782|143317796|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
71897507|NCT04799782|143317797|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
71897508|NCT02606877|143317798|OTHER||T1/R1 Ratio (%)|88.58|STANDARD_DEVIATION|45.1|||TWO_SIDED|90.0|65.4|119.97|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||119.97|65.40|
71897509|NCT02606877|143317799|OTHER||T1/R1 Ratio (%)|80.63|STANDARD_DEVIATION|74.6|||TWO_SIDED|90.0|51.27|126.79|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||126.79|51.27|
71897510|NCT02606877|143317800|OTHER||T2/R2 Ratio (%)|97.17|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|87.84|107.48|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||107.48|87.84|
71897511|NCT02606877|143317801|OTHER||T2/R2 Ratio (%)|99.49|STANDARD_DEVIATION|17.4|||TWO_SIDED|90.0|87.94|112.56|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||112.56|87.94|
71814486|NCT03502616|143130755|SUPERIORITY||LS mean difference|-13.4|STANDARD_ERROR_OF_MEAN|2.488|<|0.0001|TWO_SIDED|95.0|-18.3|-8.5|||ANCOVA|||Week 16: Analysis performed using ANCOVA model which included fixed effects of treatment group, stratification factor derived from clinical database, and baseline value.||-8.50|-18.30|<0.0001
71814487|NCT03502616|143130755|SUPERIORITY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|2.905||0.0095|TWO_SIDED|95.0|-13.32|-1.88|||Mixed Models Analysis|||Week 48: Analysis performed using MMRM which included fixed effect of treatment group, visit, and treatment-group by visit interaction, stratification factor derived from clinical database, stratification-factor by visit interaction, baseline value, and baseline-value by visit interaction.||-1.88|-13.32|0.0095
71814488|NCT03315936|143130760|OTHER||geometric mean (gMean) ratio (T/R) %|110.31|||||TWO_SIDED|90.0|100.73|120.79|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually 12 subjects were analyzed||120.79|100.73|
71897512|NCT02606877|143317802|OTHER||T1/R1 Ratio (%)|89.49|STANDARD_DEVIATION|44.3|||TWO_SIDED|90.0|66.33|120.73|||ANOVA|The analysis of variance (ANOVA) model on a logarithmic scale including effects: 'subject' and 'treatment'.|To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).|||120.73|66.33|
71897513|NCT02989727|143317814|SUPERIORITY||ANOVA estimate|1.88|STANDARD_ERROR_OF_MEAN|3.51||0.59|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.59
71897514|NCT02989727|143317815|SUPERIORITY||ANOVA estimate|0.5|STANDARD_ERROR_OF_MEAN|2.56||0.84|TWO_SIDED||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.||||.84
71897515|NCT02989727|143317816|SUPERIORITY||Cox Proportional Hazard|1.2|STANDARD_ERROR_OF_MEAN|0.1||0.08|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.08
71897516|NCT02989727|143317816|SUPERIORITY||Cox Proportional Hazard|1.08|STANDARD_ERROR_OF_MEAN|0.12||0.53|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."||||.53
71897517|NCT02989727|143317824|SUPERIORITY||Cox Proportional Hazard|1.27|STANDARD_ERROR_OF_MEAN|0.11||0.02|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.02
71897518|NCT02989727|143317824|SUPERIORITY||Cox Proportional Hazard|1.05|STANDARD_ERROR_OF_MEAN|0.13||0.73|TWO_SIDED||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."||||.73
71897519|NCT00515463|143317837|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||Risk difference \> 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.|||0.7|-0.7|
71897520|NCT00515463|143317838|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7||||||||0.7|-0.7|
71677981|NCT01154088|142874762|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|-0.41|||||TWO_SIDED|95.0|-4.11|3.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||3.25|-4.11|
71677982|NCT01154088|142874762|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|6.83|||||TWO_SIDED|95.0|3.28|10.78||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||10.78|3.28|
71677983|NCT01154088|142874762|NON_INFERIORITY|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|7.02|||||TWO_SIDED|95.0|2.63|11.58||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.||11.58|2.63|
71677984|NCT01154088|142874763|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.||1.17|0.92|
71677985|NCT01154088|142874763|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.15|||||TWO_SIDED|95.0|0.96|1.37||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.||1.37|0.96|
71677986|NCT01154088|142874763|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.91|||||TWO_SIDED|95.0|0.8|1.04||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.||1.04|0.8|
71814489|NCT03315936|143130761|OTHER||gMean ratio (T/R) %|110.83|||||TWO_SIDED|90.0|101.2|121.38|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 12.3.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||121.38|101.20|
71846047|NCT01968967|143207032|SUPERIORITY_OR_OTHER||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|2.1|3.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||3.3|2.1|
71897521|NCT00945750|143317962|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.01||||||90.0|0.94|1.09||||||||1.09|0.94|
71846048|NCT01968967|143207033|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-1.6|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.5|-1.6|
71846049|NCT01968967|143207033|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.5|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.3|-1.5|
71846050|NCT01968967|143207033|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-1.2|-1.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-1.0|-1.2|
71846051|NCT01968967|143207034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
71846052|NCT01968967|143207034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.3|-0.3|
71846053|NCT01968967|143207034|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.||-0.2|-0.3|
71846054|NCT01968967|143207035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.0|||||TWO_SIDED|95.0|19.21|38.02||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||38.02|19.21|
71846055|NCT01968967|143207035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.9|||||TWO_SIDED|95.0|9.84|16.86||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||16.86|9.84|
71846056|NCT01968967|143207035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.3|||||TWO_SIDED|95.0|4.99|8.06||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||8.06|4.99|
71846057|NCT01968967|143207036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|86.5|||||TWO_SIDED|95.0|61.74|121.25||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||121.25|61.74|
71846058|NCT01968967|143207036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|35.9|||||TWO_SIDED|95.0|26.83|47.96||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||47.96|26.83|
71846059|NCT01968967|143207036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.5|||||TWO_SIDED|95.0|18.9|34.47||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.||34.47|18.90|
71846060|NCT03335488|143207043|SUPERIORITY||Odds Ratio (OR)|1.1||||1|TWO_SIDED|95.0|0.0|28.1|||Fisher Exact|||||28.1|0.0|1.0000
71846061|NCT03335488|143207045|SUPERIORITY|||||||0.8464|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 1||||0.8464
71846062|NCT03335488|143207045|SUPERIORITY|||||||0.104|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 2||||0.1040
71846063|NCT03335488|143207045|SUPERIORITY|||||||0.0979|||||||Wilcoxon rank sum test|||Initial Treatment Period Week 3||||0.0979
71846064|NCT03335488|143207045|SUPERIORITY|||||||0.9808|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 0 Hr||||0.9808
71846065|NCT03335488|143207045|SUPERIORITY|||||||0.8329|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 4 Hr||||0.8329
71846066|NCT03335488|143207045|SUPERIORITY|||||||0.2544|||||||Wilcoxon rank sum test|||End of Initial Treatment Period Week 4 - 8 Hr||||0.2544
71846067|NCT03335488|143207046|SUPERIORITY|||||||0.8579||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.8579
71846068|NCT03335488|143207047|SUPERIORITY|||||||0.7155||||||P-value is from a t-test comparing log-transformed RAVICTI vs NaPBA values.|t-test|||||||0.7155
71846069|NCT01953692|143207055|SUPERIORITY||||||>|0.9999||||||one-sided p value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||>0.9999
71846070|NCT01953692|143207056|SUPERIORITY||||||>|0.9999||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||>0.9999
71846071|NCT01953692|143207057|SUPERIORITY|||||||0.0306||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p \> 0.10||||0.0306
71846072|NCT01953692|143207058|SUPERIORITY|||||||0.7696||||||one-sided p-value|exact binomial distribution|||Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p \> 0.25||||0.7696
71897522|NCT00945750|143317963|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.14||||||||1.14|0.93|
71897523|NCT00945750|143317964|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.11||||||90.0|1.04|1.2||||||||1.20|1.04|
71897524|NCT00945750|143317965|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||||90.0|1.02|1.24||||||||1.24|1.02|
71897525|NCT02531035|143317966|SUPERIORITY||Percentage difference|13.4|||<|0.001|TWO_SIDED|95.0|8.97|17.81||P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(\<25 kg/m\^2,\>=25 kg/m\^2),Week -2 A1C(\<=9.0%, \>9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).|Cochran-Mantel-Haenszel|||||17.81|8.97|< 0.001
71897526|NCT02531035|143317967|SUPERIORITY||Least Squares Mean Difference|-0.46|||<|0.001|TWO_SIDED|95.0|-0.54|-0.38|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.||-0.38|-0.54|< 0.001
71677987|NCT01154088|142874763|NON_INFERIORITY|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (\<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.88|||||TWO_SIDED|95.0|0.78|0.99||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.||0.99|0.78|
71677988|NCT00750139|142874776|SUPERIORITY_OR_OTHER|||||||0.01||||||The first primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025.|Cochran-Mantel-Haenszel|||"The first primary efficacy hypotheses tests are:~H01: p1 ≤ p01 vs. H1: p1 \> p01 where p01 and p1 denote the proportions of complete cure in the placebo 2wks and NAFT-500 groups, respectively."||||0.010
71677989|NCT00750139|142874776|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025|Cochran-Mantel-Haenszel|||"The second primary efficacy hypotheses tests are:~H02: p2 ≤ P02 vs. H2: P2 \> p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively"||||0.001
71677990|NCT02537431|142874778|OTHER||Mean|-54.18|||<|0.0001|TWO_SIDED|95.0|-68.64|-39.72||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-39.72|-68.64|< 0.0001
71677991|NCT02537431|142874779|OTHER||||||<|0.0001||||||The p-value is for testing the proportion of participants achieving the mean serum phosphorus levels above the LLN (2.5 mg/dL \[0.81 mmol/L\]) against 0% from the binomial test.|binomial test|||||||<0.0001
71677992|NCT02537431|142874780|OTHER||Mean|-32.21|||<|0.0001|TWO_SIDED|95.0|-40.25|-24.17||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-24.17|-40.25|<0.0001
71677993|NCT02537431|142874781|OTHER||Mean|-26.0||||0.0002|TWO_SIDED|95.0|-36.08|-15.91||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-15.91|-36.08|0.0002
71677994|NCT02537431|142874782|OTHER||Mean|-52.24||||0.0199|TWO_SIDED|95.0|-94.08|-10.41||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test|||||-10.41|-94.08|0.0199
71677995|NCT02537431|142874794|OTHER||Least Squares Mean (GEE)|107.75|||||TWO_SIDED|95.0|76.46|139.03|||||From the generalized estimation equation (GEE) model which includes change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 1||139.03|76.46|
71677996|NCT02537431|142874794|OTHER||LS Mean|48.41|||||TWO_SIDED|95.0|33.91|62.91|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 2||62.91|33.91|
71846073|NCT06193590|143207122|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||0.21
71677997|NCT02537431|142874794|OTHER||LS Mean|13.58|||||TWO_SIDED|95.0|6.85|20.31|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 4||20.31|6.85|
71677998|NCT02537431|142874794|OTHER||LS Mean|-1.34|||||TWO_SIDED|95.0|-8.43|5.75|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 20||5.75|-8.43|
71677999|NCT02537431|142874794|OTHER||LS Mean|31.75|||||TWO_SIDED|95.0|21.49|42.0|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 21||42.00|21.49|
71678000|NCT02537431|142874794|OTHER||LS Mean|11.5|||||TWO_SIDED|95.0|3.54|19.46|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 22||19.46|3.54|
71678001|NCT02537431|142874794|OTHER||LS Mean|-3.04|||||TWO_SIDED|95.0|-12.62|6.55|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 24||6.55|-12.62|
71678002|NCT02537431|142874794|OTHER||LS Mean|-1.72||||0.6821|TWO_SIDED|95.0|-9.93|6.5|||GEE model||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 48||6.50|-9.93|0.6821
71678003|NCT02537431|142874794|OTHER||LS mean|-5.73|||||TWO_SIDED|95.0|-12.38|0.92|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 60||0.92|-12.38|
71678004|NCT02537431|142874794|OTHER||LS mean|3.36|||||TWO_SIDED|95.0|-4.45|11.18|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 70||11.18|-4.45|
71678005|NCT02537431|142874794|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.22|0.13|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 72||0.13|-11.22|
71678006|NCT02537431|142874794|OTHER||LS mean|-5.55|||||TWO_SIDED|95.0|-11.35|0.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 84||0.26|-11.35|
71846074|NCT06193590|143207123|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.1
71846075|NCT06193590|143207125|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71846076|NCT03102034|143207129|OTHER||% vaccine recipients with solicited AEs|76.0|||||TWO_SIDED|90.0|56.0|90.0|||||Confidence intervals were Exact Clopper-Pearson.|||90|56|
71846077|NCT03102034|143207129|OTHER||% placebo recipients with solicited AEs|18.0|||||TWO_SIDED|90.0|3.0|47.0|||||Confidence intervals were Exact Clopper-Pearson.|||47|3|
71846078|NCT03102034|143207130|OTHER||% vaccinees with unsolicited AEs|24.0|||||TWO_SIDED|90.0|10.0|44.0|||||Confidence intervals were Exact Clopper-Pearson.|||44|10|
71846079|NCT03102034|143207130|OTHER||% placebo with unsolicited AEs|9.0|||||TWO_SIDED|90.0|0.0|36.0|||||Confidence intervals were Exact Clopper-Pearson.|||36|0|
71846080|NCT03102034|143207135|SUPERIORITY||||||<|0.001||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact|||||||<0.001
71846081|NCT03102034|143207136|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank|||||||<0.001
71846082|NCT01701401|143207199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71846083|NCT01701401|143207199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71846084|NCT01701401|143207199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71846085|NCT01701401|143207199|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test|||||||<0.001
71846086|NCT00989196|143207296|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the comparison of the PK profile of Human-cl rhFVIII with Kogenate, the 90% confidence intervals for the ratio or log-ratio of Human-cl rhFVIII over Kogenate for selected, dose independent or dose adjusted, PK parameters will be presented. In addition a formal statistical procedure will test whether the ratio of mean AUCs is within a 80 to 125% range to show bioequivalence.|Ratio|0.98|||||TWO_SIDED|90.0|0.874|1.107||||||||1.107|0.874|
71846087|NCT01000805|143207305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This p-value is for the main effect of treatment.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
71846088|NCT01000805|143207306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04|||<|0.001|TWO_SIDED|95.0|-5.83|-2.24|||Mixed Models Analysis|||||-2.24|-5.83|<0.001
71846089|NCT01000805|143207307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.112|TWO_SIDED|95.0|-1.03|0.11||This is the p-value for the Disrupt Work/School Work score.|Mixed Models Analysis|||||0.11|-1.03|0.112
71846090|NCT01000805|143207307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.005|TWO_SIDED|95.0|-1.24|-0.22||This the p-value for the Disrupt Social Life/Leisure score.|Mixed Models Analysis|||||-0.22|-1.24|0.005
71846091|NCT01000805|143207307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04|TWO_SIDED|95.0|-1.04|-0.02||This is the p-value for the Disrupt Family Life/Home score.|Mixed Models Analysis|||||-0.02|-1.04|0.040
71846092|NCT01000805|143207307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.019|TWO_SIDED|95.0|-3.2|-0.29||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.29|-3.20|0.019
71846093|NCT01000805|143207308|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.001
71846094|NCT01000805|143207309|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||This is the third gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Cochran-Mantel-Haenszel|||||||0.0082
71846095|NCT01000805|143207310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||<|0.001|TWO_SIDED|95.0|-5.2|-2.11||This is the fourth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-2.11|-5.20|<0.001
71846096|NCT01000805|143207311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19||||0.001|TWO_SIDED|95.0|-3.5|-0.89||This is the fifth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p\>0.05).|Mixed Models Analysis|||||-0.89|-3.50|0.001
71897527|NCT02531035|143317968|SUPERIORITY||Least squares mean difference|-2.98|||<|0.001|TWO_SIDED|95.0|-3.31|-2.66|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m\^2, \>=25 kg/m\^2), randomization stratum of Week -2 A1C (\<=9%, \>9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.||-2.66|-3.31|< 0.001
71897528|NCT02531035|143317969|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.002|TWO_SIDED|95.0|-5.7|-1.3|||MMRM|||Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.||-1.3|-5.7|= 0.002
71846097|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|||<|0.001|TWO_SIDED|95.0|-0.97|-0.32||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.32|-0.97|<0.001
71846098|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.34||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.34|-0.90|<0.001
71846099|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|||<|0.001|TWO_SIDED|95.0|-0.9|-0.33||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-0.90|<0.001
71846100|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|||<|0.001|TWO_SIDED|95.0|-1.06|-0.42||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.42|-1.06|<0.001
71846101|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.03|-0.33||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.33|-1.03|<0.001
71846102|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.09|-0.37||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.37|-1.09|<0.001
71846103|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.009|TWO_SIDED|95.0|-0.79|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.11|-0.79|0.009
71846104|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002|TWO_SIDED|95.0|-0.91|-0.21||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.21|-0.91|0.002
71846105|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.06|-0.35||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.35|-1.06|<0.001
71846106|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.042|TWO_SIDED|95.0|-0.76|-0.01||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.01|-0.76|0.042
71846107|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.03|-0.31||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.31|-1.03|<0.001
71846108|NCT01000805|143207312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||<|0.001|TWO_SIDED|95.0|-0.88|-0.25||This is the p-value for the main effect of treatment for the BPI Mean Pain Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.25|-0.88|<0.001
71846109|NCT01000805|143207313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|||<|0.001|TWO_SIDED|95.0|-0.71|-0.26||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.26|-0.71|<0.001
71846110|NCT01000805|143207314|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for suicidal ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.293
71846111|NCT01000805|143207315|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.033
71846112|NCT01000805|143207316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.92|||<|0.001|TWO_SIDED|95.0|1.34|4.51||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.51|1.34|<0.001
71846113|NCT01000805|143207316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4||||0.001|TWO_SIDED|95.0|0.97|3.83||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.83|0.97|0.001
71846114|NCT01000805|143207317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.083|TWO_SIDED|95.0|-0.25|4.04||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||4.04|-0.25|0.083
71897529|NCT02531035|143317970|SUPERIORITY||Least squares mean difference|-12.32|||<|0.001|TWO_SIDED|95.0|-18.17|-6.48|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (\<25 kg/m2, \>=25 kg/m2), randomization stratum of Week -2 A1C (\<=9.0%, \>9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.||-6.48|-18.17|< 0.001
71897530|NCT03567291|143318017|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.78|TWO_SIDED|95.0|-3.4|2.6|||ANCOVA|||||2.6|-3.4|0.78
71897531|NCT01103349|143318018|SUPERIORITY||Adjusted mean treatment differences|3.87|STANDARD_DEVIATION|1.494||0.005|TWO_SIDED|95.0|0.931|6.809||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||6.809|0.931|0.0050
71897532|NCT01103349|143318018|SUPERIORITY||Adjusted mean treatment differences|2.369|STANDARD_DEVIATION|1.567||0.0657||95.0|-0.713|5.452||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd) ≤ Mean FEV1 % predicted trough change from baseline (placebo)||5.452|-0.713|0.0657
71897533|NCT01103349|143318018|SUPERIORITY||Adjusted mean treatment differences|1.501|STANDARD_DEVIATION|1.602||0.1748|TWO_SIDED|95.0|-1.652|4.653||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||H0: Mean FEV1 % predicted trough change from baseline (BI671800 ED 400 mg bid) ≤ Mean FEV1 % predicted trough change from baseline (Montelukast 10 mg qd)||4.653|-1.652|0.1748
71897534|NCT01103349|143318019|SUPERIORITY||Adjusted mean treatment differences|-0.28|STANDARD_DEVIATION|0.118||0.0092|TWO_SIDED|95.0|-0.512|-0.048||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.048|-0.512|0.0092
71897535|NCT01103349|143318019|SUPERIORITY||Adjusted mean treatment differences|-0.18|STANDARD_DEVIATION|0.124||0.0732|TWO_SIDED|95.0|-0.423|0.063||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.063|-0.423|0.0732
71897536|NCT01103349|143318019|SUPERIORITY||Adjusted mean treatment differences|-0.1|STANDARD_DEVIATION|0.126||0.2139|TWO_SIDED|95.0|-0.347|0.147||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.147|-0.347|0.2139
71897537|NCT00090285|143318020|SUPERIORITY_OR_OTHER||Risk Difference (RD)|90.6||||||95.0|70.1|98.2|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.|||98.2|70.1|
71897538|NCT00090285|143318028|SUPERIORITY_OR_OTHER||Risk Difference (RD)|77.5||||||95.0|39.6|93.3||||||||93.3|39.6|
71897539|NCT00090285|143318029|SUPERIORITY_OR_OTHER||Risk Difference (RD)|85.5||||||95.0|77.0|91.3|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||91.3|77.0|
71897540|NCT00090285|143318030|SUPERIORITY_OR_OTHER||Risk Difference (RD)|51.0||||||95.0|40.3|59.9|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.|||59.9|40.3|
71897541|NCT02639182|143318049|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||||0.983||||||The stratification factors were the ECOG PS at baseline and the number of prior systemic renal cell carcinoma (RCC) regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||||0.983
71897542|NCT02639182|143318050|SUPERIORITY|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.|Hazard Ratio (HR)|1.423||||0.11|TWO_SIDED|95.0|0.924|2.192||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|||||2.192|0.924|0.110
71897543|NCT02639182|143318051|SUPERIORITY||Odds Ratio (OR)|0.4||||0.062|TWO_SIDED|95.0|0.1|1.1||A Cochran-Mantel-Haenszel (CMH) analysis of the ORR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported.||||1.1|0.1|0.062
71897544|NCT02639182|143318052|SUPERIORITY||Hazard Ratio (HR)|0.376||||0.439||95.0|0.031|4.482||The stratification factors were the ECOG PS at baseline and the number of prior systemic RCC regimens, without any other covariate(s). The model contained terms for treatment group and stratum.|Log Rank|The difference between treatment groups was tested using a stratified log rank test at a one-sided 0.1 significance level.||||4.482|0.031|0.439
71897545|NCT02639182|143318053|SUPERIORITY|||||||0.746||||||Test conducted at a 2-sided significance level of 0.05. The stratification factors were the ECOG PS at baseline and number of prior systemic RCC regimens.|Log Rank|||||||0.746
71897546|NCT02639182|143318054|SUPERIORITY|A CMH analysis of the DCR, stratified for baseline ECOG-PS and number of prior systemic therapies for RCC, was conducted at a two-sided significance level of 0.05.|Odds Ratio (OR)|0.5||||0.152|TWO_SIDED|95.0|0.2|1.3||The stratified Mantel-Haenszel estimate of the odds ratio for experiencing objective response, with the axitinib arm as the reference level, was reported as a measure of relative treatment effect, along with its two-sided 95% CI.|Cochran-Mantel-Haenszel|||||1.3|0.2|0.152
71897547|NCT03069690|143318071|SUPERIORITY||Mean Difference (Net)|-0.3996|STANDARD_ERROR_OF_MEAN|2.665||0.8|TWO_SIDED|95.0|-5.649|4.85||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.850|-5.649|.80
71897548|NCT03069690|143318071|SUPERIORITY||Mean Difference (Net)|-3.387|STANDARD_ERROR_OF_MEAN|2.755||0.8|TWO_SIDED|95.0|-8.813|2.039||The value was not adjusted for multiple comparisons.|ANCOVA|||||2.039|-8.813|.80
71897549|NCT03069690|143318071|SUPERIORITY||Mean Difference (Net)|-1.1729|STANDARD_ERROR_OF_MEAN|2.72||0.8|TWO_SIDED|95.0|-6.53|4.184||The value was not adjusted for multiple comparisons.|ANCOVA|||||4.184|-6.530|.80
71814490|NCT03315936|143130762|OTHER||gMean ratio (T/R) %|110.46|||||TWO_SIDED|90.0|89.74|135.96|||||To get, gMean ratio (T/R) and confidence interval, least square estimates of log-transformed PK endpoint for T and R were back transformed to original scale. Intra-individual geometric coefficient of variation (%) = 28.6.|The analysis of variance (ANOVA) model on the logarithmic scale including 'sequence', 'period', and 'treatment' as fixed effects and 'subject within sequence' as random effect. No hypothesis was tested and no acceptance range was specified. This was an intra-individual assessment and actually only 12 subjects were analyzed.||135.96|89.74|
71814491|NCT00770432|143130775|SUPERIORITY_OR_OTHER|||||||0.0595||95.0|||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).||||||0.0595
71814492|NCT00818363|143130776|SUPERIORITY||LS Mean Difference|-0.64||||0.303|TWO_SIDED|95.0|-1.74|0.47|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||0.47|-1.74|0.303
71846115|NCT01000805|143207317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.513|TWO_SIDED|95.0|-0.95|1.9||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||1.90|-0.95|0.513
71846116|NCT01000805|143207317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.124|TWO_SIDED|95.0|-0.42|3.47||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||3.47|-0.42|0.124
71846117|NCT01000805|143207317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.638|TWO_SIDED|95.0|-0.98|1.6||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||1.60|-0.98|0.638
71846118|NCT01000805|143207318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|||<|0.001|TWO_SIDED|95.0|-1.37|-0.54||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||-0.54|-1.37|<0.001
71846119|NCT01000805|143207318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|||<|0.001|TWO_SIDED|95.0|-1.24|-0.51||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA|||||-0.51|-1.24|<0.001
71846120|NCT02823028|143207325|SUPERIORITY||Odds Ratio (OR)|0.931||||0.779|TWO_SIDED||||||Chi-squared|||||||.779
71846121|NCT02409680|143207326|SUPERIORITY||Risk Ratio (RR)|0.89||||0.012|TWO_SIDED|95.0|0.81|0.98||A-priori threshold for statistical significance at 0.05 was specified.|Cochran-Mantel-Haenszel|||The null hypothesis is there is no treatment effect on preterm delivery.||0.98|0.81|0.012
71846122|NCT02409680|143207327|SUPERIORITY||Risk Ratio (RR)|1.08||||0.299|TWO_SIDED|95.0|0.94|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.94|0.299
71846123|NCT02409680|143207328|SUPERIORITY||Risk Ratio (RR)|0.95||||0.171|TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|0.171
71814493|NCT00818363|143130777|SUPERIORITY||LS Mean Difference|-10.25||||0.303|TWO_SIDED|95.0|-30.04|9.55|||ANCOVA|Includes treatment group and trial site as factors and age as a covariate.||||9.55|-30.04|0.303
71814494|NCT00988221|143130805|SUPERIORITY_OR_OTHER||Adjusted mean - Placebo|-22.3||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
71814495|NCT00988221|143130805|SUPERIORITY_OR_OTHER||Adjusted mean - Tocilizumab|-32.4||||||||||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||||
71846124|NCT02409680|143207329|SUPERIORITY||Risk Ratio (RR)|0.86||||0.048|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.048
71846125|NCT02409680|143207330|SUPERIORITY||Risk Ratio (RR)|0.87||||0.125|TWO_SIDED|95.0|0.73|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.73|0.125
71846126|NCT02409680|143207331|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.6|1.79|||Cochran-Mantel-Haenszel|||||1.79|0.60|0.900
71846127|NCT02409680|143207332|SUPERIORITY||Risk Ratio (RR)|1.25||||0.274|TWO_SIDED|95.0|0.84|1.86|||Cochran-Mantel-Haenszel|||||1.86|0.84|0.274
71846128|NCT02409680|143207333|SUPERIORITY||Risk Ratio (RR)|0.75||||0.512|TWO_SIDED|95.0|0.32|1.78|||Cochran-Mantel-Haenszel|||||1.78|0.32|0.512
71846129|NCT02409680|143207334|SUPERIORITY||Risk Ratio (RR)|0.77||||0.331|TWO_SIDED|95.0|0.45|1.31|||Cochran-Mantel-Haenszel|||||1.31|0.45|0.331
71846130|NCT02409680|143207336|SUPERIORITY||Risk Ratio (RR)|0.38||||0.015|TWO_SIDED|95.0|0.17|0.85|||Cochran-Mantel-Haenszel|||||0.85|0.17|0.015
71846131|NCT02409680|143207337|SUPERIORITY||Risk Ratio (RR)|0.75||||0.039|TWO_SIDED|95.0|0.61|0.93|||Cochran-Mantel-Haenszel|||||0.93|0.61|0.039
71846132|NCT02409680|143207338|SUPERIORITY||Risk Ratio (RR)|0.93||||0.073|TWO_SIDED|95.0|0.87|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.87|0.073
71846133|NCT02409680|143207339|SUPERIORITY||Risk Ratio (RR)|0.87||||0.084|TWO_SIDED|95.0|0.57|1.33|||Cochran-Mantel-Haenszel|||||1.33|0.57|0.084
71846134|NCT02409680|143207340|SUPERIORITY||Risk Ratio (RR)|0.86||||0.039|TWO_SIDED|95.0|0.73|1.0|||Cochran-Mantel-Haenszel|||||1.00|0.73|0.039
71846135|NCT02409680|143207341|SUPERIORITY||Risk Ratio (RR)|0.88||||0.261|TWO_SIDED|95.0|0.7|1.1|||Cochran-Mantel-Haenszel|||||1.10|0.70|0.261
71846136|NCT02409680|143207342|SUPERIORITY||Risk Ratio (RR)|0.85||||0.141|TWO_SIDED|95.0|0.68|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.68|0.141
71846137|NCT02409680|143207343|SUPERIORITY||Risk Ratio (RR)|1.4||||0.157|TWO_SIDED|95.0|0.88|2.23|||Cochran-Mantel-Haenszel|||||2.23|0.88|0.157
71814496|NCT00988221|143130805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.2||||0.0076|TWO_SIDED|95.0|-17.6|-2.7||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA|||||-2.7|-17.6|0.0076
71814497|NCT00988221|143130806|SUPERIORITY_OR_OTHER||Weighted difference|18.0||||1|TWO_SIDED|95.0|5.0|32.0||1.000 is used here as the test was considered as not significant due to the break in the hierarchical testing chain.|Cochran-Mantel-Haenszel|The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||The analysis used the Cochran-Mantel-Haenszel test adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||32|5|1.000
71814498|NCT00633919|143130825|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.85
71814499|NCT00633919|143130826|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|95.0|||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.52
71814500|NCT00633919|143130827|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
71814501|NCT00633919|143130828|SUPERIORITY_OR_OTHER|||||||0.0486||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||0.0486
71814502|NCT00633919|143130829|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.||||>0.05
71814503|NCT01498822|143130852|NON_INFERIORITY_OR_EQUIVALENCE|The primary analysis of this study aimed to demonstrate that LEV was noninferior to OXC with respect to the treatment failure rate in the Per Protocol Set. The noninferiority margin was 15 %.|Absolut difference|-10.7|||||TWO_SIDED|95.0|-20.2|-1.2|||Wald methodology||"Absolute difference in treatment failure rates of LEV versus OXC is defined as Treatment Failure Rate LEV minus Treatment Failure Rate OXC."|||-1.2|-20.2|
71814504|NCT04203537|143130856|SUPERIORITY|||||||0.0004|||||||ANOVA|||||||0.0004
71814505|NCT04203537|143130857|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71814506|NCT04203537|143130857|SUPERIORITY|||||||0.0026|||||||ANOVA|||||||0.0026
71814507|NCT03131960|143130878|SUPERIORITY|||||||0.0014|||||||ANCOVA|||||||0.0014
71897550|NCT04498910|143318079|SUPERIORITY||Difference in Estimated change|-1.1|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-3.6|1.2|||Bayesian Mixed Model Analysis|||||1.2|-3.6|
71897551|NCT04498910|143318080|SUPERIORITY||Difference in Estimated change|-1.5|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-4.2|1.0|||Bayesian Mixed Model Analysis|||||1.0|-4.2|
71814508|NCT03131960|143130879|SUPERIORITY|||||||0.0077|||||||ANCOVA|||ANCOVA||||0.0077
71814509|NCT03131960|143130880|SUPERIORITY|||||||0.0098|||||||Regression, Logistic|||||||0.0098
71814510|NCT03131960|143130881|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71814511|NCT01674621|143130883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0066||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0066
71814512|NCT01674621|143130883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0005
71814513|NCT01674621|143130883|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||<0.0001
71814514|NCT01674621|143130883|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.93|||||TWO_SIDED|95.0|-5.555|-2.305|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-2.305|-5.555|
71814515|NCT01674621|143130883|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.47|||||TWO_SIDED|95.0|-5.104|-1.837|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.837|-5.104|
71814516|NCT01674621|143130883|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.856|||||TWO_SIDED|95.0|-4.519|-1.193|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-1.193|-4.519|
71814517|NCT01674621|143130884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0547
71814518|NCT01674621|143130884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0056
71814519|NCT01674621|143130884|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.0018
71814520|NCT01674621|143130884|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.768|||||TWO_SIDED|95.0|-2.864|-0.672|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-0.672|-2.864|
71814521|NCT01674621|143130884|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.42|||||TWO_SIDED|95.0|-2.522|-0.318|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.318|-2.522|
71814522|NCT01674621|143130884|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.247|||||TWO_SIDED|95.0|-2.368|-0.126|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).|||-0.126|-2.368|
71897552|NCT02345434|143318122|SUPERIORITY||Mean Difference (Final Values)|3.53|||||TWO_SIDED|95.0|-6.35|13.4||||||||13.4|-6.35|
71897553|NCT02345434|143318123|SUPERIORITY||Mean Difference (Final Values)|-0.79|||||TWO_SIDED|95.0|-3.68|2.1||||||||2.1|-3.68|
71678007|NCT02537431|142874794|OTHER||LS mean|9.63|||||TWO_SIDED|95.0|1.33|17.94|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 94||17.94|1.33|
71897554|NCT02926573|143318131|SUPERIORITY||Median Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.27|0.94||||||||0.94|-0.27|
71897555|NCT02926573|143318132|SUPERIORITY||Percent Difference|9.2|||||TWO_SIDED|95.0|-3.0|21.0||||||||21|-3.0|
71897556|NCT02926573|143318134|SUPERIORITY||Percent Difference|-2.0|||||TWO_SIDED|95.0|-15.0|11.0|||||"The estimation parameter is based on those participants who answered they were very satisfied with overall pain control."|||11|-15|
71897557|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.4|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||18.3|-3.4|
71897558|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|-2.9|20.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||20.3|-2.9|
71897559|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|7.2|||||TWO_SIDED|95.0|-4.6|18.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.9|-4.6|
71897560|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|-6.6|16.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||16.8|-6.6|
71897561|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-3.6|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||18.3|-3.6|
71897562|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-5.6|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||21.6|-5.6|
71897563|NCT02926573|143318135|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|-3.5|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||23.8|-3.5|
71897564|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-0.9|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||22.3|-0.9|
71897565|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|9.1|||||TWO_SIDED|95.0|-3.4|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||21.6|-3.4|
71897566|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|6.3|||||TWO_SIDED|95.0|-6.1|18.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||18.6|-6.1|
71897567|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-7.3|17.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|||17.8|-7.3|
71897568|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|11.2|||||TWO_SIDED|95.0|-1.4|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||23.8|-1.4|
71897569|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|14.9|||||TWO_SIDED|95.0|-0.1|29.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||29.9|-0.1|
71897570|NCT02926573|143318136|SUPERIORITY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|-2.8|26.0|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||26.0|-2.8|
71897571|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|-1.4|||||TWO_SIDED|95.0|-14.7|11.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.|||11.9|-14.7|
71897572|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-8.6|19.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.|||19.2|-8.6|
71897573|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|10.9|||||TWO_SIDED|95.0|-2.4|24.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.|||24.2|-2.4|
71897574|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-6.6|20.7|||||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.|20.7|-6.6|
71897575|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|-6.4|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.|||22.3|-6.4|
71897576|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|15.7|||||TWO_SIDED|95.0|-0.4|31.7|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.|||31.7|-0.4|
71897577|NCT02926573|143318137|SUPERIORITY||Mean Difference (Final Values)|16.7|||||TWO_SIDED|95.0|0.0|33.4|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.|||33.4|0.0|
71897578|NCT02544984|143318147|SUPERIORITY|||||||0.473|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||The numbers of unscheduled clinic visits due to respiratory symptoms are compared.||||0.473
71897579|NCT02544984|143318147|SUPERIORITY|||||||0.505|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared||||0.505
71897580|NCT02544984|143318147|SUPERIORITY|||||||0.047|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of emergency room visits are compared||||0.047
71897581|NCT02544984|143318147|SUPERIORITY|||||||0.675|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of hospital admissions are compared||||0.675
71897582|NCT02544984|143318148|SUPERIORITY|||||||0.435|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||||||0.435
71897583|NCT02487745|143318153|SUPERIORITY||Odds Ratio (OR)|2.29||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
71897584|NCT02487745|143318154|SUPERIORITY||Odds Ratio (OR)|3.88||||0.05|TWO_SIDED|95.0|||||Regression, Logistic|||||||.05
71897585|NCT04083144|143318174|SUPERIORITY||η2|0.01||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
71897586|NCT04083144|143318175|SUPERIORITY||η2|0.16||||0.76|TWO_SIDED||||||Mixed Models Analysis|||||||0.76
71897587|NCT04083144|143318176|SUPERIORITY||η2|0.02||||0.98|TWO_SIDED||||||Mixed Models Analysis|||||||0.98
71897588|NCT04083144|143318177|SUPERIORITY||η2|0.07||||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71897589|NCT04083144|143318178|SUPERIORITY||η2|0.17||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
71897590|NCT01765712|143318184|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.55|TWO_SIDED|95.0|-1.99|1.03|||t-test, 2 sided|||||1.03|-1.99|0.55
71897591|NCT01004107|143318189|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71897592|NCT01004107|143318190|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71897593|NCT01004107|143318191|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71897594|NCT01004107|143318192|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71897595|NCT01004107|143318195|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71814523|NCT01674621|143130885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9493||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9493
71897596|NCT01004107|143318196|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71897597|NCT00394914|143318206|SUPERIORITY_OR_OTHER|||||||0.973|||||||Cochran-Mantel-Haenszel|||||||0.973
71897598|NCT00394914|143318207|SUPERIORITY_OR_OTHER|||||||0.425|||||||Cochran-Mantel-Haenszel|||||||0.425
71897599|NCT00872898|143318237|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.2||||0.1197|TWO_SIDED|95.0|-4.9|0.6|||mixed-model for repeated measures|||||0.6|-4.9|0.1197
71897600|NCT00872898|143318238|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9781|TWO_SIDED|95.0|-7.2|7.0|||mixed-model for repeated measures|||||7.0|-7.2|0.9781
71897601|NCT00872898|143318239|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4||||0.1459|TWO_SIDED|95.0|-3.2|0.5|||mixed-model for repeated measures|||||0.5|-3.2|0.1459
71678008|NCT02537431|142874794|OTHER||LS mean|-6.09|||||TWO_SIDED|95.0|-10.8|-1.38||||||Week 96||-1.38|-10.80|
71897602|NCT00872898|143318240|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.8||||0.1344|TWO_SIDED|95.0|-1.9|0.3|||mixed-model for repeated measures|||||0.3|-1.9|0.1344
71897603|NCT00872898|143318241|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.7|TWO_SIDED|95.0|-1.5|1.0|||mixed-model for repeated measures|||||1.0|-1.5|0.7000
71897604|NCT00872898|143318242|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.1||||0.9069|TWO_SIDED|95.0|-1.3|1.1|||mixed-model for repeated measures|||||1.1|-1.3|0.9069
71897605|NCT00872898|143318243|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.3||||0.4679|TWO_SIDED|95.0|-1.2|0.6|||mixed-model for repeated measures|||||0.6|-1.2|0.4679
71897606|NCT00872898|143318244|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9598|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9598
71897607|NCT00872898|143318245|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.9898|TWO_SIDED|95.0|-1.3|1.3|||mixed-model for repeated measures|||||1.3|-1.3|0.9898
71897608|NCT00872898|143318246|SUPERIORITY_OR_OTHER||Least squares mean difference|0.5||||0.4228|TWO_SIDED|95.0|-0.7|1.6|||mixed-model for repeated measures|||||1.6|-0.7|0.4228
71897609|NCT00872898|143318247|SUPERIORITY_OR_OTHER||Least squares mean difference|1.4||||0.0201|TWO_SIDED|95.0|0.2|2.5|||mixed-model for repeated measures|||||2.5|0.2|0.0201
71897610|NCT00872898|143318248|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.9|||mixed-model for repeated measures|||||0.9|-1.3|0.6889
71897611|NCT00872898|143318249|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2||||0.7481|TWO_SIDED|95.0|-0.9|1.2|||mixed-model for repeated measures|||||1.2|-0.9|0.7481
71897612|NCT00872898|143318250|SUPERIORITY_OR_OTHER||Least squares mean difference|0.0||||0.95|TWO_SIDED|95.0|-1.2|1.1|||mixed-model for repeated measures|||||1.1|-1.2|0.9500
71897613|NCT00044044|143318253|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71897614|NCT00044044|143318254|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71897615|NCT00044044|143318255|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71897616|NCT00044044|143318256|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71897617|NCT02179398|143318268|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
71897618|NCT02179398|143318269|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0|||||Chi-squared|||||||1
71897619|NCT02179398|143318270|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|95.0|||||Chi-squared|||Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription rate||||0.810
71897620|NCT02519231|143318326|SUPERIORITY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|5.0||0.11|TWO_SIDED|95.0||||The threshold for statistical significance was p =0.05|t-test, 2 sided|For days with bleeding/spotting outcomes, we used independent t-tests to compare the unadjusted mean difference between groups.|Treatment Difference = Naproxen - Placebo|We originally planned to enroll 60 subjects based on other similar studies that evaluated treatment for bleeding among women using contraception; as reported by Cohen et al., a sample size of 42 provided 80% power to detect a difference of 7 bleeding/spotting days in 30 days by two-sample t-test, allowing for an expected 20% drop-out.|We designed the study to include another site, in addition to the UW site enrolled participants. After 6 months of failed active recruitment at the other site, we discontinued that site from the study. Resources did not permit us to contract with an alternative recruitment site, and thus the protocol was revised to enroll 32 participants at the Seattle site only.|||.11
71897621|NCT02519231|143318327|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71897622|NCT03320512|143318366|SUPERIORITY||Average Treatment Effect|0.15||||0.04965|TWO_SIDED|95.0|0.0|0.29|||TMLE estimation of ATE and Wald test|Targeted Maximum Likelihood Estimation (TMLE) Average Treatment Effect (ATE)||Month 3 The analysis includes the intent-to-treat population||0.29|0.00|0.04965
71897623|NCT03320512|143318366|SUPERIORITY||Average Treatment Effect|-0.04||||0.62|TWO_SIDED|95.0|-0.21|0.13|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.13|-0.21|0.62
71897624|NCT03320512|143318367|SUPERIORITY||Average Treatment Effect|0.12||||0.11|TWO_SIDED|95.0|-0.03|0.26|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population||0.26|-0.03|0.11
71897625|NCT03320512|143318367|SUPERIORITY||Average Treatment Effect|0.06||||0.38|TWO_SIDED|95.0|-0.08|0.21|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population||0.21|-0.08|0.38
71897626|NCT03320512|143318368|SUPERIORITY||Average Treatment Effect|0.04||||0.68|TWO_SIDED|95.0|-0.09|0.16||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.16|-0.09|0.68
71846138|NCT05200416|143207373|SUPERIORITY||Mean Difference (Final Values)|11.42|||<|0.001|TWO_SIDED|95.0|7.83|15.01|||Mixed Models Analysis|||||15.01|7.83|<0.001
71846139|NCT05200416|143207374|SUPERIORITY||Mean Difference (Final Values)|-4.16||||0.001|TWO_SIDED|95.0|-6.69|-1.63|||Mixed Models Analysis|||||-1.63|-6.69|0.001
71846140|NCT05986617|143207375|SUPERIORITY|||||||0.06429||||||2-tail t-test with non-equivalent variances|t-test, 2 sided|||Power calculation: 2 factor (group, time) ANOVA design with a group\*time interaction term to estimate the proposed sample size. Using a Cohen's effect size estimate for 2 groups with 5 time-points, a sample size of 40 per group will provide \>90% to detect a moderate effect size (0.25) for group, for time and for the group\*time interaction.||||.06429
71846141|NCT03789656|143207378|OTHER|||||||0.6285|||||||Wilcoxon Signed Rank test|||The primary efficacy endpoint was completed with the Efficacy Analysis Set (EAS), which included all treated subjects in Group 1. The median (Interquartile range) for change from baseline in IGF-1xULN to Week 13/EoT and p-value from the Wilcoxon signed rank test were presented. Baseline was defined as the mean of all IGF-1xULN values prior to first dose. Last on treatment assessment was used for EoT if subject discontinued before Week 13.||||0.6285
71846142|NCT03789656|143207379|OTHER|||||||0.3877|||||||exact binomial test assuming the null pr|Null proportion = 0.5||||||0.3877
71846143|NCT06214052|143207409|OTHER||Emax|-2.69|STANDARD_ERROR_OF_MEAN|5.0||||||||||||||||
71846144|NCT06214052|143207409|OTHER||EC50|1.88|STANDARD_ERROR_OF_MEAN|26.0||||||||||||||||
71846145|NCT02434328|143207414|NON_INFERIORITY|The noninferiority margin was 4 letters.|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|<|0.0001|TWO_SIDED|95.0|-2.4|1.0||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.0|-2.4|<0.0001
71846146|NCT02434328|143207415|NON_INFERIORITY|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|-2.8|0.5||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||0.5|-2.8|0.0003
71846147|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||0.0|-2.0|
71846148|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.2|0.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||0.2|-2.2|
71846149|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.71|||TWO_SIDED|95.0|-2.4|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.4|-2.4|
71846150|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-2.3|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||0.6|-2.3|
71897627|NCT03320512|143318368|SUPERIORITY||Average Treatment Effect|0.11||||0.53|TWO_SIDED|95.0|-0.03|0.25||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.25|-0.03|0.53
71897628|NCT03320512|143318369|SUPERIORITY||Average Treatment Effect|0.06||||0.53|TWO_SIDED|95.0|-0.02|0.15||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.15|-0.02|0.53
71897629|NCT03320512|143318369|SUPERIORITY||Average Treatment Effect|0.0||||0.96|TWO_SIDED|95.0|-0.12|0.12||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.12|-0.12|0.96
71897630|NCT03320512|143318370|SUPERIORITY||Average Treatment Effect|0.08||||0.93|TWO_SIDED|95.0|-0.84|1.0||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.00|-0.84|0.93
71897631|NCT03320512|143318370|SUPERIORITY||Average Treatment Effect|-1.12||||0.6|TWO_SIDED|95.0|-4.16|1.91||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.91|-4.16|0.60
71897632|NCT03320512|143318371|SUPERIORITY||Average Treatment Effect|0.73||||0.6|TWO_SIDED|95.0|-1.03|2.48||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||2.48|-1.03|0.60
71897633|NCT03320512|143318371|SUPERIORITY||Average Treatment Effect|-0.91||||0.6|TWO_SIDED|95.0|-2.86|1.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||1.04|-2.86|0.60
71897634|NCT03320512|143318372|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.2|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.20|0.60
71897635|NCT03320512|143318372|SUPERIORITY||Average Treatment Effect|-0.06||||0.6|TWO_SIDED|95.0|-0.21|0.09||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Gonorrhea The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.09|-0.21|0.60
71897636|NCT03320512|143318372|SUPERIORITY||Average Treatment Effect|-0.13||||0.53|TWO_SIDED|95.0|-0.3|0.03||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.03|-0.30|0.53
71897637|NCT03320512|143318372|SUPERIORITY||Average Treatment Effect|-0.08||||0.6|TWO_SIDED|95.0|-0.24|0.08||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Chlamydia The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.08|-0.24|0.60
71897638|NCT03320512|143318372|SUPERIORITY||Average Treatment Effect|-0.11||||0.53|TWO_SIDED|95.0|-0.25|0.04||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 3 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.04|-0.25|0.53
71897639|NCT03320512|143318372|SUPERIORITY||Average Treatment Effect|-0.07||||0.6|TWO_SIDED|95.0|-0.2|0.07||P-values adjusted using the Benjamini Hochberg procedure.|TMLE estimation of ATE and Wald test|||Month 6 Syphillis The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.07|-0.20|0.60
71897640|NCT03320512|143318373|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.07|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.29|-0.07|
71897641|NCT03320512|143318373|SUPERIORITY||Average Treatment Effect|0.19|||||TWO_SIDED|95.0|0.03|0.34|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.34|0.03|
71897642|NCT03320512|143318373|SUPERIORITY||Average Treatment Effect|-0.06|||||TWO_SIDED|95.0|-0.27|0.15|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.15|-0.27|
71897643|NCT03320512|143318373|SUPERIORITY||Average Treatment Effect|-0.02|||||TWO_SIDED|95.0|-0.21|0.16|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.16|-0.21|
71897644|NCT03320512|143318374|SUPERIORITY||Average Treatment Effect|0.11|||||TWO_SIDED|95.0|-0.05|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.05|
71897645|NCT03320512|143318374|SUPERIORITY||Average Treatment Effect|0.13|||||TWO_SIDED|95.0|-0.04|0.29|||||TMLE estimation of ATE and Wald Confidence Interval|Month 3 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.29|-0.04|
71897646|NCT03320512|143318374|SUPERIORITY||Average Treatment Effect|0.09|||||TWO_SIDED|95.0|-0.08|0.26|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3 vs. Control.||0.26|-0.08|
71897647|NCT03320512|143318374|SUPERIORITY||Average Treatment Effect|0.03|||||TWO_SIDED|95.0|-0.13|0.19|||||TMLE estimation of ATE and Wald Confidence Interval|Month 6 The analysis includes the intent-to-treat population and compares P3+ vs. Control.||0.19|-0.13|
71897648|NCT03320512|143318375|SUPERIORITY||Average Treatment Effect|0.09||||0.11|TWO_SIDED|95.0|-0.02|0.19|||TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.19|-0.02|0.11
71814524|NCT01674621|143130885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9806||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.9806
71814525|NCT01674621|143130885|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5191||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.||||||0.5191
71814526|NCT01674621|143130885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.168|1.04|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.040|-2.168|
71814527|NCT01674621|143130885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.483|||||TWO_SIDED|95.0|-2.115|1.15|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||1.150|-2.115|
71846151|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|95.0|-3.0|0.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||0.0|-3.0|
71846152|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|95.0|-2.5|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||0.6|-2.5|
71846153|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.7|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||0.5|-2.7|
71846154|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-2.5|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||0.7|-2.5|
71846155|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|95.0|-2.9|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||0.4|-2.9|
71846156|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-2.9|0.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||0.5|-2.9|
71846157|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-3.2|0.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||0.1|-3.2|
71846158|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|95.0|-2.4|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||1.0|-2.4|
71846159|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||1.1|-2.5|
71846160|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.92|||TWO_SIDED|95.0|-2.5|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||1.1|-2.5|
71897649|NCT03320512|143318375|SUPERIORITY||Average Treatment Effect|-0.01||||0.82|TWO_SIDED|95.0|-0.14|0.11|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||0.11|-0.14|0.82
71897650|NCT03320512|143318376|SUPERIORITY||Average Treatment Effect|8.95||||0.05|TWO_SIDED|95.0|0.07|17.83||The a priori threshold for statistical significance is 0.025.|TMLE estimation of ATE and Wald test|||Month 3 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||17.83|0.07|0.05
71897651|NCT03320512|143318376|SUPERIORITY||Average Treatment Effect|-3.69||||0.45|TWO_SIDED|95.0|-13.33|5.95|||TMLE estimation of ATE and Wald test|||Month 6 The analysis includes the intent-to-treat population and compares P3 and P3+ vs. Control.||5.95|-13.33|0.45
71897652|NCT03320512|143318377|SUPERIORITY||Incremental cost effectiveness ratio|25.79|||||TWO_SIDED|95.0|-194.05|236.81|||||The confidence interval was created using percentile bootstrap.|Participants were included if they were at an active site with cost data and had a 3-month binary TFV measure.||236.81|-194.05|
71814528|NCT01674621|143130885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-1.106|2.139|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||2.139|-1.106|
71814529|NCT01674621|143130886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2549||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2549
71814530|NCT01674621|143130886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9115||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9115
71814531|NCT01674621|143130886|SUPERIORITY_OR_OTHER_LEGACY|||||||0.239||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.2390
71814532|NCT01674621|143130886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.146|||||TWO_SIDED|95.0|-40.501|-3.79|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-3.790|-40.501|
71814533|NCT01674621|143130886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.086|||||TWO_SIDED|95.0|-30.543|6.372|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||6.372|-30.543|
71814534|NCT01674621|143130886|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.828|||||TWO_SIDED|95.0|-41.614|-4.041|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).|||-4.041|-41.614|
71814535|NCT01674621|143130887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1632
71814536|NCT01674621|143130887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.9834
71814537|NCT01674621|143130887|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2179||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.||||||0.2179
71814538|NCT01674621|143130887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.541|||||TWO_SIDED|95.0|-48.557|-6.525|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-6.525|-48.557|
71814539|NCT01674621|143130887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.702|||||TWO_SIDED|95.0|-39.835|2.43|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||2.430|-39.835|
71814540|NCT01674621|143130887|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.914|||||TWO_SIDED|95.0|-48.424|-5.405|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-5.405|-48.424|
71814541|NCT01674621|143130888|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||1.0000
71814542|NCT01674621|143130888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.1200
71814543|NCT01674621|143130888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9998||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.||||||0.9998
71814544|NCT01674621|143130888|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.906|||||TWO_SIDED|95.0|-96.926|-50.886|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-50.886|-96.926|
71814545|NCT01674621|143130888|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-62.872|||||TWO_SIDED|95.0|-86.019|-39.725|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-39.725|-86.019|
71814546|NCT01674621|143130888|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-73.367|||||TWO_SIDED|95.0|-96.927|-49.807|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.807|-96.927|
71814547|NCT01674621|143130889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8569||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.8569
71814548|NCT01674621|143130889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6091||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6091
71814549|NCT01674621|143130889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9999||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.||||||0.9999
71814550|NCT01674621|143130889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-110.398|||||TWO_SIDED|95.0|-156.966|-63.831|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-63.831|-156.966|
71814551|NCT01674621|143130889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-96.115|||||TWO_SIDED|95.0|-142.94|-49.29|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-49.290|-142.940|
71814552|NCT01674621|143130889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-104.418|||||TWO_SIDED|95.0|-152.079|-56.758|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-56.758|-152.079|
71814553|NCT01674621|143130890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3483||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.3483
71814554|NCT01674621|143130890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6839||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.6839
71814555|NCT01674621|143130890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1067||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.||||||0.1067
71814556|NCT01674621|143130890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-43.721|||||TWO_SIDED|95.0|-75.748|-11.694|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-11.694|-75.748|
71814557|NCT01674621|143130890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.461|||||TWO_SIDED|95.0|-71.665|-7.257|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-7.257|-71.665|
71678009|NCT02537431|142874794|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-9.22|9.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 108||9.26|-9.22|
71678010|NCT02537431|142874794|OTHER||LS mean|1.45|||||TWO_SIDED|95.0|-6.77|9.68|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 120||9.68|-6.77|
71678011|NCT02537431|142874794|OTHER||LS mean|-1.69|||||TWO_SIDED|95.0|-5.6|2.21|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 132||2.21|-5.60|
71678012|NCT02537431|142874795|OTHER||LS Mean|0.1|||||TWO_SIDED|95.0|-0.15|0.35|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 12||0.35|-0.15|
71678013|NCT02537431|142874795|OTHER||LS Mean|-0.04|||||TWO_SIDED|95.0|-0.19|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 24||0.11|-0.19|
71814558|NCT01674621|143130890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.334|||||TWO_SIDED|95.0|-82.113|-16.555|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).|||-16.555|-82.113|
71814559|NCT01859793|143130897|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.||||<0.05
71814560|NCT01859793|143130898|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
71678014|NCT02537431|142874795|OTHER||LS Mean|-0.01|||||TWO_SIDED|95.0|-0.12|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 36||0.11|-0.12|
71678015|NCT02537431|142874795|OTHER||LS Mean|-0.04||||0.6021|TWO_SIDED|95.0|-0.19|0.11|||GEE model||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 48||0.11|-0.19|0.6021
71678016|NCT02537431|142874795|OTHER||LS mean|0.0|||||TWO_SIDED|95.0|-0.19|0.19|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 72||0.19|-0.19|
71678017|NCT02537431|142874795|OTHER||LS mean|-0.13|||||TWO_SIDED|95.0|-0.29|0.03|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 96||0.03|-0.29|
71678018|NCT02537431|142874795|OTHER||LS mean|-0.07|||||TWO_SIDED|95.0|-0.41|0.26|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|EOS II||0.26|-0.41|
71678019|NCT02537431|142874796|OTHER||LS Mean|1.76|||||TWO_SIDED|95.0|1.49|2.03|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 2||2.03|1.49|
71678020|NCT02537431|142874796|OTHER||LS Mean|0.78|||||TWO_SIDED|95.0|0.59|0.97|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 4||0.97|0.59|
71678021|NCT02537431|142874796|OTHER||LS Mean|0.58|||||TWO_SIDED|95.0|0.34|0.82|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 12||0.82|0.34|
71678022|NCT02537431|142874796|OTHER||LS Mean|0.87|||||TWO_SIDED|95.0|0.74|0.99|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 22||0.99|0.74|
71678023|NCT02537431|142874796|OTHER||LS Mean|0.44|||||TWO_SIDED|95.0|0.24|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 24||0.64|0.24|
71678024|NCT02537431|142874796|OTHER||LS Mean|0.2||||0.043|TWO_SIDED|95.0|0.01|0.38|||GEE model||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 48||0.38|0.01|0.0430
71678025|NCT02537431|142874796|OTHER||LS mean|0.3|||||TWO_SIDED|95.0|-0.04|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 60||0.64|-0.04|
71678026|NCT02537431|142874796|OTHER||LS mean|0.28|||||TWO_SIDED|95.0|0.03|0.52|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 72||0.52|0.03|
71678027|NCT02537431|142874796|OTHER||LS mean|0.39|||||TWO_SIDED|95.0|0.13|0.66|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 84||0.66|0.13|
71678028|NCT02537431|142874796|OTHER||LS mean|0.29|||||TWO_SIDED|95.0|0.1|0.48|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 96||0.48|0.10|
71678029|NCT02537431|142874796|OTHER||LS mean|0.21|||||TWO_SIDED|95.0|0.08|0.34|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|EOSII||0.34|0.08|
71678030|NCT02537431|142874797|OTHER||LS Mean|0.07|||||TWO_SIDED|95.0|0.06|0.08|||||From the GEE model, which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 2||0.08|0.06|
71846161|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-2.7|1.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||1.0|-2.7|
71846162|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.95|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||1.2|-2.5|
71846163|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|95.0|-2.5|1.2||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||1.2|-2.5|
71846164|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.8|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||1.1|-2.8|
71846165|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||1.4|-2.5|
71846166|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.1|1.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||1.8|-2.1|
71846167|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-2.9|1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||1.1|-2.9|
71846168|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.6|1.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||1.3|-2.6|
71846169|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-2.4|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||1.6|-2.4|
71846170|NCT02434328|143207420|OTHER|Treatment difference|Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|95.0|-2.5|1.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||1.6|-2.5|
71678031|NCT02537431|142874797|OTHER||LS Mean|0.03|||||TWO_SIDED|95.0|0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 4||0.06|0.01|
71678032|NCT02537431|142874797|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.01|0.04|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 12||0.04|-0.01|
71678033|NCT02537431|142874797|OTHER||LS Mean|0.04|||||TWO_SIDED|95.0|0.02|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 22||0.05|0.02|
71678034|NCT02537431|142874797|OTHER||LS Mean|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||Week 24||0.04|-0.02|
71678035|NCT02537431|142874797|OTHER||LS Mean|0.0||||0.8377|TWO_SIDED|95.0|-0.05|0.04|||GEE model||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 48||0.04|-0.05|0.8377
71678036|NCT02537431|142874797|OTHER||LS mean|0.03|||||TWO_SIDED|95.0|0.0|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 60||0.06|-0.00|
71678037|NCT02537431|142874797|OTHER||LS mean|-0.02|||||TWO_SIDED|95.0|-0.09|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 72||0.05|-0.09|
71678038|NCT02537431|142874797|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 84||0.06|-0.01|
71678039|NCT02537431|142874797|OTHER||LS mean|0.02|||||TWO_SIDED|95.0|-0.01|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 96||0.05|-0.01|
71678040|NCT02537431|142874797|OTHER||LS mean|0.01|||||TWO_SIDED|95.0|-0.01|0.03|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|EOSII||0.03|-0.01|
71846171|NCT02434328|143207421|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-2.4|0.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||0.3|-2.4|
71846172|NCT02434328|143207421|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-2.4|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||0.7|-2.4|
71846173|NCT02434328|143207422|OTHER|Treatment difference|Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.5|0.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48||0.4|-2.5|
71846174|NCT02434328|143207422|OTHER|Treatment difference|Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.4|0.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.||Week 12 to Week 96|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|0.8|-2.4|
71846175|NCT02434328|143207423|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|95.0|-2.5|1.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||1.4|-2.5|
71846176|NCT02434328|143207424|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-5.1|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||2.9|-5.1|
71846177|NCT02434328|143207424|OTHER||Difference in proportions|-4.3|||||TWO_SIDED|95.0|-9.5|1.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.0|-9.5|
71846178|NCT02434328|143207424|OTHER||Difference in proportions|-5.0|||||TWO_SIDED|95.0|-10.5|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||0.3|-10.5|
71846179|NCT02434328|143207424|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-8.4|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||3.7|-8.4|
71846180|NCT02434328|143207424|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-8.8|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.8|-8.8|
71846181|NCT02434328|143207424|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.2|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||6.7|-5.2|
71846182|NCT02434328|143207424|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.9|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-9.9|
71846183|NCT02434328|143207424|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.5|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.7|-10.5|
71846184|NCT02434328|143207424|OTHER||Difference in proportions|-4.9|||||TWO_SIDED|95.0|-11.6|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.3|-11.6|
71897653|NCT00638846|143318378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.739|||||TWO_SIDED|97.4|1.136|1.739|||Generalized Linear Model||Odds ratio was senofilcon A toric / balafilcon A toric|Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation||1.739|1.136|
71678041|NCT02537431|142874798|OTHER||LS Mean|99.18|||||TWO_SIDED|95.0|76.83|121.53|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||121.53|76.83|
71897654|NCT00638846|143318379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.138|||||TWO_SIDED|97.4|0.624|1.138|||Generalized Linear Model||Odds ratio was senofilcon A toric/balafilcon A toric|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.||1.138|0.624|
71897655|NCT00638846|143318380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1307|STANDARD_ERROR_OF_MEAN|0.2856|||TWO_SIDED|97.5|-1.1307|-0.568|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon At toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.||-0.5680|-1.1307|
71897656|NCT00638846|143318381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A is superior to balafilcon A.||0.3680|0.07001|
71897657|NCT00638846|143318382|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is -0.4.|Mean Difference (Final Values)|-0.0688|STANDARD_ERROR_OF_MEAN|0.1648|||TWO_SIDED|97.5|-0.0688|-0.0197|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.||-0.0197|-0.0688|
71897658|NCT00638846|143318383|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.368|STANDARD_ERROR_OF_MEAN|0.1331|||TWO_SIDED|97.4|0.07001|0.368|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.||0.3680|0.07001|
71678042|NCT02537431|142874798|OTHER||LS Mean|104.33|||||TWO_SIDED|95.0|82.47|126.19|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||126.19|82.47|
71814561|NCT01859793|143130899|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey's test were applied if significant differences were detected||||<0.05
71814562|NCT01148862|143130906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.2||||0.006|||||||ANCOVA|||||||0.006
71814563|NCT01148862|143130907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.015||95.0|||||ANCOVA|||||||0.015
71814564|NCT00895622|143130923|OTHER||Kappa statistic|0.79|||<|0.0001|TWO_SIDED|95.0|0.71|0.87|||Z test|||"The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):~\< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.~The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement."||0.87|0.71|<0.0001
71846185|NCT02434328|143207424|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-11.5|1.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||1.9|-11.5|
71846186|NCT02434328|143207424|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.3|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||1.8|-11.3|
71846187|NCT02434328|143207424|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.1|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||5.8|-7.1|
71846188|NCT02434328|143207424|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-7.0|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.5|-7.0|
71846189|NCT02434328|143207424|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.7|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.4|-7.7|
71897659|NCT02746679|143318384|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
71897660|NCT02746679|143318385|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71814565|NCT02237508|143130940|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|138.87|||<|0.001|TWO_SIDED|90.0|129.09|149.39|||Mixed Models Analysis|||||149.39|129.09|<0.001
71897661|NCT02746679|143318386|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71897662|NCT02746679|143318387|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||||||0.024
71897663|NCT02746679|143318388|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
71897664|NCT02746679|143318389|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
71897665|NCT02746679|143318390|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.003
71897666|NCT02746679|143318391|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.024
71897667|NCT02746679|143318392|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.004
71897668|NCT02746679|143318393|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
71897669|NCT02746679|143318394|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||<0.001
71897670|NCT02746679|143318395|SUPERIORITY_OR_OTHER|||||||0.277|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.277
71897671|NCT02746679|143318396|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.||||||0.001
71897672|NCT00866294|143318407|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.8|-1.1||The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.|ANCOVA|The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).|Mean difference = paroxetine CR minus placebo|||-1.1|-3.8|<0.001
71897673|NCT03990766|143318447|SUPERIORITY||Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-35.6|42.3||||||||42.3|-35.6|
71897674|NCT03990766|143318448|SUPERIORITY||Median Difference (Net)|1.0|||||TWO_SIDED|95.0|-3.0|5.0||||||||5|-3|
71897675|NCT03990766|143318449|SUPERIORITY||Median Difference (Net)|-10.0|||||TWO_SIDED|95.0|-15.0|-4.0||||||The within-subject change in QOD-NS scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort.||-4|-15|
71897676|NCT03990766|143318450|SUPERIORITY||Median Difference (Net)|7.0|||||TWO_SIDED|95.0|-2.0|17.0||||||The within-subject change in ODOR scores from baseline and 6 weeks was calculated for each individual patient. Then the median of all the patients' change in score for each cohort was calculated. Because these were within-subject changes in scores, the median difference values for each cohort do not necessarily correspond with simply subtracting the median change in score in the theophylline cohort from the median change in score in the placebo cohort. We confirmed the reported results.||17|-2|
71897677|NCT03825042|143318451|SUPERIORITY||Mean Difference (Final Values)|-21.01||||0|TWO_SIDED|95.0|-26.8|-15.2|||ANCOVA|||||-15.20|-26.80|0.0000
71897678|NCT03825042|143318452|SUPERIORITY||Mean Difference (Final Values)|-6.08||||0|TWO_SIDED|95.0|-8.45|-3.61|||ANCOVA|||||-3.61|-8.45|0.0000
71897679|NCT03825042|143318453|SUPERIORITY||Mean Difference (Final Values)|-14.56||||0|TWO_SIDED|95.0|-20.02|-9.11|||ANCOVA|||||-9.11|-20.02|0.0000
71897680|NCT02316470|143318454|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71897681|NCT02316470|143318454|SUPERIORITY_OR_OTHER|||||||0.0261|||||||Cochran-Mantel-Haenszel|||||||0.0261
71897682|NCT02316470|143318454|SUPERIORITY_OR_OTHER|||||||0.0364|||||||Cochran-Mantel-Haenszel|||||||0.0364
71897683|NCT02316470|143318454|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71897684|NCT02316470|143318454|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71897685|NCT02316470|143318454|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71897686|NCT02316470|143318454|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71897687|NCT02316470|143318455|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
71897688|NCT02316470|143318456|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
71897689|NCT02316470|143318457|SUPERIORITY_OR_OTHER||||||<|0.0001||||||the p-value was \<0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.||||<0.0001
71897690|NCT02385123|143318524|OTHER||||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897691|NCT02385123|143318525|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897692|NCT02385123|143318526|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71678043|NCT02537431|142874798|OTHER||LS Mean|52.49|||<|0.0001|TWO_SIDED|95.0|29.84|75.13|||GEE model||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||75.13|29.84|< 0.0001
71678044|NCT02537431|142874798|OTHER||LS mean|37.29|||||TWO_SIDED|95.0|13.19|61.38|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||61.38|13.19|
71678045|NCT02537431|142874798|OTHER||LS mean|29.29|||||TWO_SIDED|95.0|3.18|55.4|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||55.40|3.18|
71678046|NCT02537431|142874798|OTHER||LS mean|2.14|||||TWO_SIDED|95.0|-17.67|21.94|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||21.94|-17.67|
71814566|NCT02237508|143130940|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|136.18|||<|0.001|TWO_SIDED|90.0|126.13|147.04|||Mixed Models Analysis|||||147.04|126.13|<0.001
71814567|NCT02237508|143130941|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|119.73||||0.001|TWO_SIDED|90.0|109.4|131.03|||Mixed Models Analysis|||||131.03|109.40|0.001
71814568|NCT02237508|143130941|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|129.62|||<|0.001|TWO_SIDED|90.0|117.33|143.2|||Mixed Models Analysis|||||143.20|117.33|<0.001
71814569|NCT02237508|143130942|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|218.13|||<|0.001|TWO_SIDED|90.0|194.02|245.24|||Mixed Models Analysis|||||245.24|194.02|<0.001
71678047|NCT02537431|142874799|OTHER||LS Mean|133.08|||||TWO_SIDED|95.0|106.26|159.89|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12||159.89|106.26|
71678048|NCT02537431|142874799|OTHER||LS Mean|137.8|||||TWO_SIDED|95.0|106.95|168.65|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24||168.65|106.95|
71678049|NCT02537431|142874799|OTHER||LS Mean|76.86|||<|0.0001|TWO_SIDED|95.0|49.2|104.53|||GEE model||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48||104.53|49.20|< 0.0001
71678050|NCT02537431|142874799|OTHER||LS mean|50.46|||||TWO_SIDED|95.0|23.69|77.23|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72||77.23|23.69|
71678051|NCT02537431|142874799|OTHER||LS mean|41.36|||||TWO_SIDED|95.0|18.69|64.03|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96||64.03|18.69|
71678052|NCT02537431|142874799|OTHER||LS mean|26.2|||||TWO_SIDED|95.0|6.76|45.64|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII||45.64|6.76|
71678053|NCT02537431|142874800|OTHER||LS Mean|464.84|||||TWO_SIDED|95.0|343.92|585.77|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||585.77|343.92|
71678054|NCT02537431|142874800|OTHER||LS Mean|404.13|||||TWO_SIDED|95.0|294.47|513.78|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||513.78|294.47|
71678055|NCT02537431|142874800|OTHER||LS Mean|175.13|||<|0.0001|TWO_SIDED|95.0|88.85|261.41|||GEE model||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||261.41|88.85|< 0.0001
71678056|NCT02537431|142874800|OTHER||LS mean|143.11|||||TWO_SIDED|95.0|-38.2|324.41|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||324.41|-38.20|
71678057|NCT02537431|142874800|OTHER||LS mean|76.8|||||TWO_SIDED|95.0|-35.62|189.22|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||189.22|-35.62|
71814570|NCT02237508|143130942|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|200.66|||<|0.001|TWO_SIDED|90.0|174.3|231.01|||Mixed Models Analysis|||||231.01|174.30|<0.001
71814571|NCT02237508|143130943|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|126.17|||<|0.001|TWO_SIDED|90.0|115.93|137.32|||Mixed Models Analysis|||||137.32|115.93|<0.001
71814572|NCT02237508|143130943|EQUIVALENCE|"Z7200 was considered bioequivalent to the reference if the following criteria were satisfied:~* the 90%CI for the geometric mean AUC0-t ratio was within the interval 80.00% to 125.00% for both budesonide and formoterol, with and without charcoal blockade and~* the 90%CI for the geometric mean ratio for Cmax was within the wider bioequivalence acceptance limits of (69.84%, 143.19%) for budesonide and (71.92%, 139.04%) for formoterol, respectively with and without charcoal blockade."|Adjusted geometric means ratio|117.08||||0.004|TWO_SIDED|90.0|107.05|128.05|||Mixed Models Analysis|||||128.05|107.05|0.004
71814573|NCT01905046|143130992|SUPERIORITY||Odds Ratio (OR)|0.97||||0.951|TWO_SIDED|95.0|0.36|2.62|||Chi-squared|||||2.62|0.36|0.951
71814574|NCT03489057|143131005|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
71814575|NCT03489057|143131019|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||||||0.48
71814576|NCT02277743|143131045|SUPERIORITY||difference in percentages|27.7|||<|0.0001|TWO_SIDED|95.0|20.18|35.17||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||35.17|20.18|< 0.0001
71814577|NCT02277743|143131045|SUPERIORITY||difference in percentages|27.0|||<|0.0001|TWO_SIDED|95.0|19.47|34.44||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.44|19.47|< 0.0001
71814578|NCT02277743|143131046|SUPERIORITY||difference in percentages|36.6|||<|0.0001|TWO_SIDED|95.0|28.58|44.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||44.63|28.58|< 0.0001
71814579|NCT02277743|143131046|SUPERIORITY||difference in percentages|37.7|||<|0.0001|TWO_SIDED|95.0|29.7|45.77||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||45.77|29.70|< 0.0001
71814580|NCT02277743|143131047|SUPERIORITY||difference in percentages|28.6|||<|0.0001|TWO_SIDED|95.0|20.64|36.52||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.52|20.64|< 0.0001
71814581|NCT02277743|143131047|SUPERIORITY||difference in percentages|28.0|||<|0.0001|TWO_SIDED|95.0|19.94|36.13||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.13|19.94|< 0.0001
71814582|NCT02277743|143131048|SUPERIORITY||difference in percentages|29.6|||<|0.0001|TWO_SIDED|95.0|21.36|37.88||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||37.88|21.36|< 0.0001
71814583|NCT02277743|143131048|SUPERIORITY||difference in percentages|34.5|||<|0.0001|TWO_SIDED|95.0|26.08|42.84||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||42.84|26.08|< 0.0001
71814584|NCT02277743|143131049|SUPERIORITY||Least square (LS) mean difference|-24.9|||<|0.0001|TWO_SIDED|95.0|-32.26|-17.52||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-17.52|-32.26|< 0.0001
71814585|NCT02277743|143131049|SUPERIORITY||LS mean difference|-22.8|||<|0.0001|TWO_SIDED|95.0|-30.33|-15.33||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-15.33|-30.33|< 0.0001
71814586|NCT02277743|143131050|SUPERIORITY||difference in percentages|9.8||||0.0012|TWO_SIDED|95.0|3.95|15.71||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||15.71|3.95|0.0012
71897693|NCT02385123|143318527|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people|||
71897694|NCT02385123|143318528|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897695|NCT02385123|143318529|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897696|NCT02385123|143318530|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897697|NCT02385123|143318531|OTHER|||||||||||||||||A single group analysis was used to determine this outcome measure.|A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897698|NCT02385123|143318532|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897699|NCT02385123|143318533|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71814587|NCT02277743|143131050|SUPERIORITY||difference in percentages|17.3|||<|0.0001|TWO_SIDED|95.0|10.57|23.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||23.93|10.57|< 0.0001
71814588|NCT02277743|143131051|SUPERIORITY||difference in percentages|6.1||||0.0097|TWO_SIDED|95.0|1.49|10.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.68|1.49|0.0097
71814589|NCT02277743|143131051|SUPERIORITY||difference in percentages|6.2||||0.0094|TWO_SIDED|95.0|1.45|10.86||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||10.86|1.45|0.0094
71814590|NCT02277743|143131052|SUPERIORITY||LS mean difference|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.236|-1.26||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.260|-2.236|< 0.0001
71814591|NCT02277743|143131052|SUPERIORITY||LS mean difference|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.189|-1.186||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.186|-2.189|< 0.0001
71814592|NCT02277743|143131053|SUPERIORITY||LS mean difference|-34.6|||<|0.0001|TWO_SIDED|95.0|-42.35|-26.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.88|-42.35|< 0.0001
71814593|NCT02277743|143131053|SUPERIORITY||LS mean difference|-34.4|||<|0.0001|TWO_SIDED|95.0|-42.17|-26.56||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-26.56|-42.17|< 0.0001
71814594|NCT02277743|143131054|SUPERIORITY||difference in percentages|44.2|||<|0.0001|TWO_SIDED|95.0|35.91|52.48||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||52.48|35.91|< 0.0001
71814595|NCT02277743|143131054|SUPERIORITY||difference in percentages|36.4|||<|0.0001|TWO_SIDED|95.0|27.9|44.96||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||44.96|27.90|< 0.0001
71814596|NCT02277743|143131055|SUPERIORITY||difference in percentages|28.1|||<|0.0001|TWO_SIDED|95.0|20.96|35.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||35.29|20.96|< 0.0001
71814597|NCT02277743|143131055|SUPERIORITY||difference in percentages|25.6|||<|0.0001|TWO_SIDED|95.0|18.51|32.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||32.68|18.51|< 0.0001
71814598|NCT02277743|143131056|SUPERIORITY||LS mean difference|-17.92|||<|0.0001|TWO_SIDED|95.0|-22.487|-13.353||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-13.353|-22.487|< 0.0001
71814599|NCT02277743|143131056|SUPERIORITY||LS mean difference|-18.89|||<|0.0001|TWO_SIDED|95.0|-23.125|-14.65||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-14.650|-23.125|< 0.0001
71814600|NCT02277743|143131057|SUPERIORITY||LS mean difference|-28.7|||<|0.0001|TWO_SIDED|95.0|-35.79|-21.54||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-21.54|-35.79|< 0.0001
71814601|NCT02277743|143131057|SUPERIORITY||LS mean difference|-28.0|||<|0.0001|TWO_SIDED|95.0|-35.09|-20.87||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-20.87|-35.09|< 0.0001
71814602|NCT02277743|143131058|SUPERIORITY||LS mean difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.16|-2.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.80|-5.16|< 0.0001
71814603|NCT02277743|143131058|SUPERIORITY||LS mean difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.87|-2.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-2.49|-4.87|< 0.0001
71814604|NCT02277743|143131059|SUPERIORITY||LS mean difference|-6.5|||<|0.0001|TWO_SIDED|95.0|-8.02|-5.01||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.01|-8.02|< 0.0001
71814605|NCT02277743|143131059|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.44|-4.32||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-4.32|-7.44|< 0.0001
71814606|NCT02277743|143131060|SUPERIORITY||LS mean difference|-2.2||||0.0006|TWO_SIDED|95.0|-3.44|-0.95||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-0.95|-3.44|0.0006
71814607|NCT02277743|143131060|SUPERIORITY||LS mean difference|-2.2||||0.0003|TWO_SIDED|95.0|-3.46|-1.03||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-1.03|-3.46|0.0003
71814608|NCT02277743|143131061|SUPERIORITY||LS mean difference|-27.0|||<|0.0001|TWO_SIDED|95.0|-35.04|-18.91||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.91|-35.04|< 0.0001
71814609|NCT02277743|143131061|SUPERIORITY||LS mean difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-33.06|-18.12||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-18.12|-33.06|< 0.0001
71814610|NCT02277743|143131062|SUPERIORITY||LS mean difference|-16.5|||<|0.0001|TWO_SIDED|95.0|-21.08|-11.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-11.90|-21.08|< 0.0001
71814611|NCT02277743|143131062|SUPERIORITY||LS mean difference|-15.1|||<|0.0001|TWO_SIDED|95.0|-19.62|-10.5||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).||-10.50|-19.62|< 0.0001
71814612|NCT01622010|143131072|EQUIVALENCE|P value 0.05 used||||||0.487|||||||Chi-squared|||||||0.487
71814613|NCT01622010|143131074|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|a non-inferiority margin calculation was not performed for this study prior to its start.||||||0.628|||||||Fisher Exact|||Null hypothesis: Standard care is better than standard care with video enhancement.||||0.628
71814614|NCT01622010|143131075|EQUIVALENCE|P Value 0.05 used||||||0.647|||||||Chi-squared|||||||0.647
71846190|NCT02434328|143207424|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-8.3|
71846191|NCT02434328|143207424|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.9|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-7.9|
71846192|NCT02434328|143207424|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-9.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.1|-9.9|
71846193|NCT02434328|143207424|OTHER||Difference in proportions|-4.1|||||TWO_SIDED|95.0|-10.2|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.3|-10.2|
71846194|NCT02434328|143207424|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.0|-8.8|
71846195|NCT02434328|143207424|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.0|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.5|-9.0|
71846196|NCT02434328|143207424|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-9.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.8|-9.9|
71897700|NCT02385123|143318534|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897701|NCT02385123|143318535|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897702|NCT02385123|143318536|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897703|NCT02385123|143318537|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897704|NCT02385123|143318539|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897705|NCT02385123|143318540|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897706|NCT02385123|143318541|OTHER|Single group analysis.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897707|NCT02385123|143318542|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897708|NCT02385123|143318543|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897709|NCT02385123|143318544|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71897710|NCT02385123|143318545|OTHER|A single group analysis was used to determine this outcome measure.|||||||||||||||||A single group analysis was used to determine this outcome measure. These are basic science, hypothesis-generating studies with limited numbers of participants and no control group. The outcomes have no comparisons built into them - the outcomes are stating what the cell counts are, what the antibody titers are, what percentage of people seroconverted, etc. As such, we cannot report any p-values etc. for comparisons (e.g. with unvaccinated people).|||
71846197|NCT02434328|143207424|OTHER||Difference in proportions|-5.8|||||TWO_SIDED|95.0|-11.8|0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||0.3|-11.8|
71846198|NCT02434328|143207424|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||4.5|-7.9|
71846199|NCT02434328|143207424|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.8|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.8|
71846200|NCT02434328|143207425|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-7.6|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.8|-7.6|
71846201|NCT02434328|143207425|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-13.0|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||0.1|-13.0|
71846202|NCT02434328|143207425|OTHER||Difference in proportions|-3.8|||||TWO_SIDED|95.0|-10.1|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.4|-10.1|
71846203|NCT02434328|143207425|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-7.3|6.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.3|-7.3|
71846204|NCT02434328|143207425|OTHER||Difference in proportions|-4.6|||||TWO_SIDED|95.0|-11.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||2.2|-11.2|
71846205|NCT02434328|143207425|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.0|-10.7|
71846206|NCT02434328|143207425|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-9.6|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||4.0|-9.6|
71846207|NCT02434328|143207425|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-9.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.5|-9.4|
71846208|NCT02434328|143207425|OTHER||Difference in proportions|-5.4|||||TWO_SIDED|95.0|-12.1|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.1|-12.1|
71846209|NCT02434328|143207425|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.9|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.5|-9.9|
71846210|NCT02434328|143207425|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-10.3|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||4.2|-10.3|
71846211|NCT02434328|143207425|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.7|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||4.7|-8.7|
71678058|NCT02537431|142874800|OTHER||LS mean|-41.32|||||TWO_SIDED|95.0|-204.28|121.64|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||121.64|-204.28|
71846212|NCT02434328|143207425|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.0|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.7|-8.0|
71846213|NCT02434328|143207425|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.3|-9.8|
71846214|NCT02434328|143207425|OTHER|Hypothesis testing not pre-specified.|Difference in proportions|-2.8|||||TWO_SIDED|95.0|-9.6|4.2|||Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-9.6|
71846215|NCT02434328|143207425|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.8|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-8.8|
71846216|NCT02434328|143207425|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.4|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||5.0|-8.4|
71846217|NCT02434328|143207425|OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.4|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||2.9|-10.4|
71846218|NCT02434328|143207425|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-6.5|7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||7.2|-6.5|
71846219|NCT02434328|143207425|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.5|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.1|-7.5|
71846220|NCT02434328|143207425|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.1|-10.4|
71846221|NCT02434328|143207425|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-9.6|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-9.6|
71846222|NCT02434328|143207425|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-5.0|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.3|-5.0|
71846223|NCT02434328|143207425|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.0|6.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||6.8|-7.0|
71846224|NCT02434328|143207426|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-10.4|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.6|-10.4|
71846225|NCT02434328|143207426|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-10.2|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-10.2|
71846226|NCT02434328|143207426|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-10.7|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.3|-10.7|
71846227|NCT02434328|143207426|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-8.4|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||5.7|-8.4|
71846228|NCT02434328|143207426|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-12.3|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||1.5|-12.3|
71897711|NCT01327339|143318603|SUPERIORITY_OR_OTHER||percentage of participants|5.9|||||TWO_SIDED|95.0|4.3|7.8|||||The estimated value represents the percentage of participants with an adverse event.|||7.8|4.3|
71897712|NCT01847547|143318609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||||95.0|0.64|1.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.70|0.64|
71897713|NCT01847547|143318610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.69|1.36|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.36|0.69|
71846229|NCT02434328|143207426|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.7|-9.9|
71897714|NCT01847547|143318611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||||95.0|0.62|2.45|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.45|0.62|
71897715|NCT01847547|143318612|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||||95.0|0.15|0.59|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.59|0.15|
71897716|NCT01847547|143318613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||||95.0|0.15|0.67|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||0.67|0.15|
71897717|NCT01847547|143318614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||||95.0|0.09|0.84|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.84|0.09|
71897718|NCT01847547|143318615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.78|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.78|
71897719|NCT01847547|143318617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.48|1.14|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.14|0.48|
71897720|NCT01847547|143318618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||||95.0|0.47|2.2|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.20|0.47|
71897721|NCT01847547|143318619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||||95.0|0.21|1.98|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.98|0.21|
71897722|NCT01847547|143318620|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||||95.0|0.5|1.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.08|0.50|
71897723|NCT01847547|143318621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||||95.0|0.21|0.76|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||0.76|0.21|
71846230|NCT02434328|143207426|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-12.8|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||0.7|-12.8|
71846231|NCT02434328|143207426|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-8.2|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.8|-8.2|
71846232|NCT02434328|143207426|OTHER||Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.2|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-9.2|
71846233|NCT02434328|143207426|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-8.2|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-8.2|
71897724|NCT01847547|143318622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.58|1.55|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||1.55|0.58|
71678059|NCT02537431|142874801|OTHER||LS Mean|89.68|||||TWO_SIDED|95.0|63.58|115.78|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12||115.78|63.58|
71678060|NCT02537431|142874801|OTHER||LS Mean|70.17|||||TWO_SIDED|95.0|49.9|90.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24||90.44|49.90|
71678061|NCT02537431|142874801|OTHER||LS Mean|35.86|||<|0.0001|TWO_SIDED|95.0|21.37|50.36|||GEE model||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48||50.36|21.37|< 0.0001
71678062|NCT02537431|142874801|OTHER||LS mean|34.0|||||TWO_SIDED|95.0|6.53|61.47|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72||61.47|6.53|
71814615|NCT03976466|143131099|SUPERIORITY||Risk Ratio (RR)|0.049|||<|0.05|TWO_SIDED|95.0|0.015|0.168|||Chi-squared, Corrected||For the Relative risk the control Study group was the numerator and control group denominator. In the 2X2 contingency table the rows correspond to groups and columns for the presence or abscence of periprosthetic infection.|"H0.- There is no significant difference in the incidence of periprosthetic infection in patients with non-modifiable risk factors and prophylactic application of antibiotic loaded calcium sulfate compared with patients without prophylactic treatment with calcium sulfate.~The presence of periprosthetic infection in both groups was evaluated by chi2 and Lambda tests for dichotomous nominal and qualitative variables with longitudinal direction and relative risk factor test."||0.168|0.015|<0.05
71814616|NCT03976466|143131100|SUPERIORITY||||||<|0.01||||||The statistical test of t was performed for the variable length of hospital stay, finding a significant difference with a p value \< 0.01|t-test, 2 sided|||Lenght of stay was the variable that compares both groups and was a continous variable (t-test).||||<0.01
71814617|NCT00733499|143131101|OTHER|||||||0.9478|||||||t-test, 2 sided|||||||0.9478
71814618|NCT00733499|143131102|OTHER|||||||0.549|||||||t-test, 2 sided|||||||0.5490
71814619|NCT00733499|143131103|OTHER|||||||0.5312|||||||t-test, 2 sided|||||||0.5312
71814620|NCT00733499|143131104|OTHER|||||||0.3549|||||||t-test, 2 sided|||||||0.3549
71678063|NCT02537431|142874801|OTHER||LS mean|25.86|||||TWO_SIDED|95.0|9.27|42.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96||42.44|9.27|
71678064|NCT02537431|142874801|OTHER||LS mean|17.88|||||TWO_SIDED|95.0|-0.32|36.07|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII||36.07|-0.32|
71678065|NCT02537431|142874802|OTHER||LS Mean|10.93|||||TWO_SIDED|95.0|3.98|17.89|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||17.89|3.98|
71678066|NCT02537431|142874802|OTHER||LS Mean|5.82|||||TWO_SIDED|95.0|-0.02|11.66|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||11.66|-0.02|
71678067|NCT02537431|142874802|OTHER||LS Mean|4.5||||0.2592|TWO_SIDED|95.0|-3.32|12.32|||GEE model||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||12.32|-3.32|0.2592
71678068|NCT02537431|142874802|OTHER||LS mean|3.13|||||TWO_SIDED|95.0|-1.64|7.9|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||7.90|-1.64|
71678069|NCT02537431|142874802|OTHER||LS mean|1.14|||||TWO_SIDED|95.0|-2.84|5.11|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||5.11|-2.84|
71678070|NCT02537431|142874802|OTHER||LS mean|-5.8|||||TWO_SIDED|95.0|-12.46|0.85|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||0.85|-12.46|
71678071|NCT02537431|142874803|OTHER||LS Mean|52.54|||||TWO_SIDED|95.0|21.18|83.9|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12||83.90|21.18|
71678072|NCT02537431|142874803|OTHER||LS Mean|31.37|||||TWO_SIDED|95.0|8.23|54.51|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24||54.51|8.23|
71814621|NCT00733499|143131105|OTHER|||||||0.0513|||||||t-test, 2 sided|||||||0.0513
71814622|NCT00733499|143131106|OTHER|||||||0.0629|||||||t-test, 2 sided|||||||0.0629
71814623|NCT00733499|143131107|OTHER|||||||0.0327|||||||t-test, 2 sided|||||||0.0327
71814624|NCT00733499|143131108|OTHER|||||||0.0883|||||||t-test, 2 sided|||||||0.0883
71814625|NCT00733499|143131109|OTHER|||||||0.6801|||||||Wilcoxon (Mann-Whitney)|||||||0.6801
71814626|NCT00733499|143131110|OTHER|||||||0.4779|||||||t-test, 2 sided|||||||0.4779
71814627|NCT00733499|143131111|OTHER|||||||0.8007|||||||t-test, 2 sided|||||||0.8007
71814628|NCT00733499|143131112|OTHER|||||||0.3317|||||||t-test, 2 sided|||||||0.3317
71814629|NCT00733499|143131113|OTHER|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
71814630|NCT00733499|143131114|OTHER|||||||0.2116|||||||t-test, 2 sided|||||||0.2116
71814631|NCT00733499|143131115|OTHER|||||||0.4776|||||||t-test, 2 sided|||||||0.4776
71814632|NCT00733499|143131117|OTHER|||||||0.2935|||||||t-test, 2 sided|||||||0.2935
71897725|NCT01847547|143318623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|0.32|5.72|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||5.72|0.32|
71897726|NCT01847547|143318624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||||95.0|0.83|3.08|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.08|0.83|
71897727|NCT01847547|143318625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||||95.0|0.57|3.7|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||3.70|0.57|
71897728|NCT01847547|143318626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.67|1.35|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.||1.35|0.67|
71814633|NCT00733499|143131118|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
71814634|NCT00733499|143131119|OTHER|||||||0.6896|||||||t-test, 2 sided|||||||0.6896
71846234|NCT02434328|143207426|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-8.5|
71846235|NCT02434328|143207426|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-7.4|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.2|-7.4|
71846236|NCT02434328|143207426|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.8|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.0|-9.8|
71846237|NCT02434328|143207426|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-8.6|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.8|-8.6|
71846238|NCT02434328|143207426|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-7.8|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||6.1|-7.8|
71846239|NCT02434328|143207426|OTHER||Difference in proportions|2.3|||||TWO_SIDED|95.0|-4.5|9.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||9.2|-4.5|
71846240|NCT02434328|143207426|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-8.6|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||4.9|-8.6|
71846241|NCT02434328|143207426|OTHER||Difference in proportions|1.1|||||TWO_SIDED|95.0|-5.8|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||7.5|-5.8|
71846242|NCT02434328|143207426|OTHER||Difference in proportions|2.0|||||TWO_SIDED|95.0|-5.1|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||8.4|-5.1|
71846243|NCT02434328|143207426|OTHER||Difference in proportions|4.2|||||TWO_SIDED|95.0|-2.8|10.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||10.9|-2.8|
71846244|NCT02434328|143207426|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-9.3|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-9.3|
71897729|NCT01847547|143318627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||||95.0|0.79|2.01|||Regression, Cox||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.||2.01|0.79|
71897730|NCT00700752|143318628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1636|STANDARD_ERROR_OF_MEAN|0.1887|||TWO_SIDED|95.0|0.789|1.1636|||Mixed Models Analysis||The mean difference is calculated as senofilcon A minus balafilcon A.|Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.||1.1636|0.7890|
71897731|NCT00510692|143318638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06||||0.005|TWO_SIDED|95.0|-1.78|-0.35|||ANCOVA|||||-0.35|-1.78|0.005
71814635|NCT00733499|143131120|OTHER|||||||0.1076|||||||t-test, 2 sided|||||||0.1076
71814636|NCT00733499|143131121|OTHER|||||||0.9042|||||||t-test, 2 sided|||||||0.9042
71814637|NCT00733499|143131122|OTHER|||||||0.9637|||||||t-test, 2 sided|||||||0.9637
71814638|NCT00733499|143131123|OTHER|||||||0.0485|||||||t-test, 2 sided|||||||0.0485
71814639|NCT00733499|143131124|OTHER|||||||0.9813|||||||t-test, 2 sided|||||||0.9813
71814640|NCT01552954|143131128|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||for albuminuria changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||Differences with two-tailed P\<0.05 were considered statistically significant.||||0.006
71814641|NCT01552954|143131128|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks|Mixed Models Analysis|||||||0.99
71897732|NCT01845077|143318643|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|95.3|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|95.3|
71897733|NCT01845077|143318643|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|101.5|||||TWO_SIDED|90.0|98.4|104.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment.||104.7|98.4|
71897734|NCT01845077|143318643|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|100.9|||||TWO_SIDED|90.0|98.2|103.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.7|98.2|
71897735|NCT01845077|143318644|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|94.9|||||TWO_SIDED|90.0|86.8|103.6|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.6|86.8|
71897736|NCT01845077|143318644|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|90.2|103.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.8|90.2|
71897737|NCT01845077|143318644|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|108.6||||||90.0|99.5|118.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||118.5|99.5|
71897738|NCT01845077|143318645|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.7|||||TWO_SIDED|90.0|97.1|110.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||110.8|97.1|
71897739|NCT01845077|143318645|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|105.3|||||TWO_SIDED|90.0|99.9|111.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||111.0|99.9|
71897740|NCT01845077|143318645|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|90.2|104.1|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||104.1|90.2|
71897741|NCT01845077|143318646|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||TWO_SIDED|90.0|86.8|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.8|
71897742|NCT01845077|143318646|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.7|||||TWO_SIDED|90.0|96.1|103.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.5|96.1|
71897743|NCT01845077|143318646|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|95.9|||||TWO_SIDED|90.0|86.7|106.0|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||106.0|86.7|
71897744|NCT01845077|143318647|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||TWO_SIDED|90.0|86.6|108.2|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||108.2|86.6|
71897745|NCT01845077|143318647|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.4|||||TWO_SIDED|90.0|95.6|103.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||103.4|95.6|
71897746|NCT01845077|143318647|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||TWO_SIDED|90.0|90.1|109.5|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.5|90.1|
71897747|NCT01845077|143318648|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.5|||||TWO_SIDED|90.0|84.8|109.8|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||109.8|84.8|
71678073|NCT02537431|142874803|OTHER||l|24.35||||0.1672|TWO_SIDED|95.0|-10.2|58.9|||GEE model||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48||58.90|-10.20|0.1672
71678074|NCT02537431|142874803|OTHER||LS mean|15.13|||||TWO_SIDED|95.0|-11.19|41.46|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72||41.46|-11.19|
71678075|NCT02537431|142874803|OTHER||LS mean|6.92|||||TWO_SIDED|95.0|-13.44|27.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96||27.28|-13.44|
71678076|NCT02537431|142874803|OTHER||LS mean|-27.3|||||TWO_SIDED|95.0|-52.33|-2.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII||-2.28|-52.33|
71678077|NCT01662791|142874807|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||Comparison between the groups for \>12 ppm.||||1.0
71678078|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.235|||||||Chi-squared|||Comparison between groups for mobility sub-scale.||||0.235
71814642|NCT01552954|143131128|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group|Mixed Models Analysis|||||||0.001
71814643|NCT01552954|143131129|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED|||||for hemoglobin changes from week 0 at week 16 (week 0 - week 16)|t-test, 2 sided|||||||0.187
71678079|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.206|||||||Chi-squared|||Comparison between groups for activities of daily living sub-scale.||||0.206
71678080|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.641|||||||Chi-squared|||Comparison between groups for emotional well-being sub-scale.||||0.641
71678081|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.446|||||||Chi-squared|||Comparison between groups for stigma sub-scale.||||0.446
71678082|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.466|||||||Chi-squared|||Comparison between groups for social support sub-scale.||||0.466
71678083|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.205|||||||Chi-squared|||Comparison between groups for cognition sub-scale.||||0.205
71678084|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.153|||||||Chi-squared|||Comparison between groups for communication sub-scale.||||0.153
71678085|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.73|||||||Chi-squared|||Comparison between groups for bodily discomfort sub-scale.||||0.730
71678086|NCT01662791|142874808|SUPERIORITY_OR_OTHER|||||||0.334|||||||Chi-squared|||Comparison between groups for summary index sub-scale.||||0.334
71678087|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.167|||||||McNemar|||Comparison in case group between baseline and 3 months for mobility sub-scale.||||0.167
71678088|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.159|||||||McNemar|||Comparison in case group between baseline and 3 months for activities of daily living sub-scale.||||0.159
71678089|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.041|||||||McNemar|||Comparison in case group between baseline and 3 months for emotional well-being sub-scale.||||0.041
71678090|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.19|||||||McNemar|||Comparison in case group between baseline and 3 months for stigma sub-scale.||||0.190
71678091|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|||Comparison in case group between baseline and 3 months for social support sub-scale.||||1.0
71678092|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.16|||||||McNemar|||Comparison in case group between baseline and 3 months for cognition sub-scale.||||0.160
71678093|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.276|||||||McNemar|||Comparison in case group between baseline and 3 months for communication sub-scale.||||0.276
71678094|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for bodily discomfort sub-scale.||||0.351
71678095|NCT01662791|142874809|SUPERIORITY_OR_OTHER|||||||0.186|||||||McNemar|||Comparison in case group between baseline and 3 months for summary index sub-scale.||||0.186
71678096|NCT01662791|142874810|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||Comparison between groups for constipation sub-scale.||||0.303
71678097|NCT01662791|142874810|SUPERIORITY_OR_OTHER|||||||0.518|||||||Chi-squared|||Comparison between groups for dyspepsia sub-scale.||||0.518
71678098|NCT01662791|142874810|SUPERIORITY_OR_OTHER|||||||0.8|||||||Chi-squared|||Comparison between groups for abdominal discomfort sub-scale.||||0.800
71678099|NCT01662791|142874810|SUPERIORITY_OR_OTHER|||||||0.736|||||||Chi-squared|||Comparison between groups for diarrhea sub-scale.||||0.736
71678100|NCT01662791|142874810|SUPERIORITY_OR_OTHER|||||||0.57|||||||Chi-squared|||Comparison between groups for GERD sub-scale.||||0.570
71678101|NCT01662791|142874810|SUPERIORITY_OR_OTHER|||||||0.394|||||||Chi-squared|||Comparison between groups for nausea and vomiting sub-scale.||||0.394
71678102|NCT01662791|142874811|SUPERIORITY_OR_OTHER|||||||0.056|||||||McNemar|||Comparison in case group between baseline and 3 months for constipation sub-scale.||||0.056
71678103|NCT01662791|142874811|SUPERIORITY_OR_OTHER|||||||0.38|||||||McNemar|||Comparison in case group between baseline and 3 months for dyspepsia sub-scale.||||0.380
71678104|NCT01662791|142874811|SUPERIORITY_OR_OTHER|||||||0.244|||||||McNemar|||Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale.||||0.244
71678105|NCT01662791|142874811|SUPERIORITY_OR_OTHER|||||||0.279|||||||McNemar|||Comparison in case group between baseline and 3 months for diarrhea sub-scale.||||0.279
71678106|NCT01662791|142874811|SUPERIORITY_OR_OTHER|||||||0.554|||||||McNemar|||Comparison in case group between baseline and 3 months for GERD sub-scale.||||0.554
71678107|NCT01662791|142874811|SUPERIORITY_OR_OTHER|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale.||||0.351
71678108|NCT01662791|142874812|SUPERIORITY_OR_OTHER|||||||0.872|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for depression||||0.872
71678109|NCT01662791|142874812|SUPERIORITY_OR_OTHER|||||||0.835|TWO_SIDED||||||t-test, 1 sided|||Comparison between the two groups at baseline for anxiety.||||0.835
71814644|NCT01552954|143131130|SUPERIORITY_OR_OTHER|||||||0.001||||||for changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.001
71678110|NCT01640379|142874821|SUPERIORITY||Odds Ratio (OR)|0.4||||0.07|TWO_SIDED|95.0|0.15|1.09||Judged by type one error limit alpha = 0.05.|t-test, 2 sided||The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.|A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.||1.09|0.15|0.070
71678111|NCT01640379|142874821|SUPERIORITY||Odds Ratio (OR)|0.59||||0.043|TWO_SIDED|95.0|0.39|0.98||Judged by type one error limit alpha = 0.05.|generalized estimating equations||The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.|"We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.~The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm."||0.98|0.39|0.043
71678112|NCT01640379|142874822|SUPERIORITY||Odds Ratio (OR)|92.2|||<|0.001|TWO_SIDED|95.0|37.0|230.1|||Chi-squared|Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.|Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.|H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.||230.1|37.0|<0.001
71678113|NCT01640379|142874822|SUPERIORITY||Odds Ratio (OR)|0.6||||0.084|TWO_SIDED|95.0|0.36|1.05|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for intervention arm relative to control.|H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.||1.05|0.36|0.084
71678114|NCT01640379|142874822|SUPERIORITY||Odds Ratio (OR)|0.9||||0.867|TWO_SIDED|95.0|0.36|2.34|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.|H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.||2.34|0.36|0.867
71814645|NCT01552954|143131131|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||for sBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||>0.05
71814646|NCT01552954|143131131|SUPERIORITY_OR_OTHER|||||||0.585|TWO_SIDED|||||for dBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||||||0.585
71814647|NCT04843930|143131134|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.54|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 261.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.54
71846245|NCT02434328|143207426|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-6.1|7.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||7.7|-6.1|
71678115|NCT01640379|142874822|SUPERIORITY||Odds Ratio (OR)|0.6||||0.153|TWO_SIDED|95.0|0.33|1.19|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.|H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.||1.19|0.33|0.153
71678116|NCT01640379|142874822|SUPERIORITY||Odds Ratio (OR)|1.0||||0.351|TWO_SIDED|95.0|0.86|1.06|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for women in the TECH-N arm relative to women in the control arm.|H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.||1.06|0.86|0.351
71678117|NCT03395184|142874823|OTHER||Percentage risk difference|14.3||||0.0119|TWO_SIDED|90.0|4.0|24.5|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum (min) risk weight method (Mehrotra-Railkar 2000)|||24.5|4.0|0.0119
71678118|NCT03395184|142874823|OTHER||Percentage risk difference|21.4||||0.0012|TWO_SIDED|90.0|10.0|32.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||32.9|10.0|0.0012
71678119|NCT03395184|142874837|OTHER||Percentage risk difference|13.3||||0.039|TWO_SIDED|90.0|1.0|25.7|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.7|1.0|0.0390
71678120|NCT03395184|142874837|OTHER||Percentage risk difference|29.7||||0.0001|TWO_SIDED|90.0|17.2|42.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||42.2|17.2|0.0001
71678121|NCT03395184|142874838|OTHER||LS mean difference|-3.0||||0.0007|TWO_SIDED|90.0|-4.55|-1.48|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-1.48|-4.55|0.0007
71678122|NCT03395184|142874838|OTHER||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|90.0|-6.62|-3.26|||ANCOVA|The ANCOVA model included treatment and baseline disease activity/extent as factors, and baseline SES-CD score as a covariate.||||-3.26|-6.62|<.0001
71678123|NCT03395184|142874839|OTHER||Percentage risk difference|13.9||||0.0279|TWO_SIDED|90.0|2.1|25.6|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using using minimum risk weight method (Mehrotra-Railkar, 2000).|||25.6|2.1|0.0279
71678124|NCT03395184|142874839|OTHER||Percentage risk difference|31.5|||<|0.0001|TWO_SIDED|90.0|19.1|43.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||43.9|19.1|<.0001
71678125|NCT03395184|142874840|OTHER||Percentage risk difference|2.5||||0.2922|TWO_SIDED|90.0|-4.3|9.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||9.3|-4.3|0.2922
71897748|NCT01845077|143318648|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.2|||||TWO_SIDED|90.0|98.9|107.7|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||107.7|98.9|
71678126|NCT03395184|142874840|OTHER||Percentage risk difference|7.4||||0.0449|TWO_SIDED|90.0|-0.4|15.2|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||15.2|-0.4|0.0449
71897749|NCT01845077|143318648|NON_INFERIORITY_OR_EQUIVALENCE|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|107.7|||||TWO_SIDED|90.0|92.5|125.4|||ANOVA|ANOVA on the logarithmic scale, adjusted for subjects within sequences as random effect and sequence, period and treatment as fixed effects.||||125.4|92.5|
71897750|NCT04036136|143318711|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.36||||0.724|TWO_SIDED|95.0|-2.41|1.68|||ANCOVA|||Model covariates are Baseline SHAPS, age, and sex.||1.68|-2.41|0.724
71678127|NCT03395184|142874841|OTHER||Percentage risk difference|5.8||||0.0998|TWO_SIDED|90.0|-1.6|13.3|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||13.3|-1.6|0.0998
71897751|NCT04036136|143318712|EQUIVALENCE|The equivalence margin is 0.|Mean Difference (Final Values)|-0.043||||0.292|TWO_SIDED|95.0|-0.124|0.038|||Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.038|-0.124|0.292
71897752|NCT04036136|143318713|EQUIVALENCE|The equivalence margin is 0.|Median Difference (Final Values)|-0.148||||0.084|TWO_SIDED|95.0|-0.316|0.02||The equivalence margin is 0.|Regression, Linear|||Model covariates are Baseline fMRI, age, and sex.||0.020|-0.316|0.084
71897753|NCT02961764|143318722|SUPERIORITY||Odds Ratio (OR)|0.289|||<|0.001|TWO_SIDED|95.0|0.156|0.532|||Fisher Exact|||||0.532|0.156|<0.001
71897754|NCT02961764|143318723|SUPERIORITY|||||||0.005|||||||t-test, 1 sided|||||||0.005
71897755|NCT02961764|143318724|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|||||||0.050
71897756|NCT02961764|143318726|SUPERIORITY|||||||0.002|||||||t-test, 1 sided|||||||0.002
71897757|NCT00916721|143318788|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Multiple significance testing:we adjusted p-value by controlling the expected proportion of falsely rejected hypotheses:false discovery rate,Benjamini||||||0.05
71897758|NCT01797029|143318791|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71897759|NCT02101411|143318864|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.19|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||The differences among the three PRU groups (\<85, 85-208,\>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.||||0.002
71897760|NCT02101411|143318864|OTHER|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Hazard Ratio (HR)|1.02|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value \< 5, then Fisher's exact test was used.|Chi-squared|||The differences among the three PRU groups (\<85, 85-208,\>208) and ADEs were compared using the Chi-squared test.||||0.002
71897761|NCT03242759|143318872|OTHER|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.505
71897762|NCT03242759|143318872|OTHER|||||||0.181|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.181
71897763|NCT03242759|143318873|OTHER|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.571
71897764|NCT03242759|143318873|OTHER|||||||0.232|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.232
71897765|NCT03242759|143318874|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
71678128|NCT03395184|142874841|OTHER||Percentage risk difference|11.8||||0.0111|TWO_SIDED|90.0|2.8|20.9|||Min risk weight method(Mehrotra-Railkar)||90% CI was calculated using minimum risk weight method (Mehrotra-Railkar, 2000).|||20.9|2.8|0.0111
71678129|NCT02833844|142874890|SUPERIORITY||treatment difference|-56.92|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-61.55|-52.28||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-52.28|-61.55|< 0.0001
71678130|NCT02833844|142874891|SUPERIORITY||treatment difference|-75.2|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-82.1|-68.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-68.4|-82.1|< 0.0001
71678131|NCT02833844|142874892|SUPERIORITY||treatment difference|65.4|||<|0.0001|TWO_SIDED|95.0|57.8|71.1||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||71.1|57.8|< 0.0001
71897766|NCT03242759|143318874|OTHER|||||||0.375|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.375
71897767|NCT03242759|143318875|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.027
71897768|NCT03242759|143318875|OTHER|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.938
71897769|NCT03242759|143318876|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.001
71814648|NCT04843930|143131135|SUPERIORITY||Mean Difference (Final Values)|2.83||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 239.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis."||||0.04
71897770|NCT03242759|143318876|OTHER|||||||0.048|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.048
71897771|NCT03242759|143318877|OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.018
71897772|NCT03242759|143318877|OTHER|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.125
71897773|NCT03242759|143318878|OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.073
71897774|NCT03242759|143318878|OTHER|||||||0.755|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.755
71897775|NCT03242759|143318879|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
71897776|NCT03242759|143318879|OTHER|||||||0.281|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.281
71897777|NCT03242759|143318880|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
71897778|NCT03242759|143318880|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.008
71897779|NCT03242759|143318881|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
71897780|NCT03242759|143318881|OTHER|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.031
71897781|NCT03242759|143318883|OTHER||||||<|0.001|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||< 0.001
71897782|NCT03242759|143318883|OTHER|||||||0.939|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.939
71897783|NCT03242759|143318884|OTHER|||||||0.169|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.169
71897784|NCT03242759|143318884|OTHER|||||||0.545|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.545
71897785|NCT03242759|143318885|OTHER|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||Intra-group difference comparing to baseline was analyzed.||||0.333
71897786|NCT03242759|143318885|OTHER|||||||0.786|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.786
71897787|NCT03242759|143318886|OTHER|||||||0.245|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.245
71897788|NCT03242759|143318886|OTHER|||||||0.454|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.454
71897789|NCT03242759|143318887|OTHER|||||||0.543|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.543
71897790|NCT03242759|143318887|OTHER|||||||0.733|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.733
71897791|NCT03242759|143318888|OTHER|||||||0.046|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.046
71897792|NCT03242759|143318888|OTHER|||||||0.898|||||||Paired t-test|||Intra-group difference comparing to baseline was analyzed.||||0.898
71897793|NCT00336492|143318925|SUPERIORITY_OR_OTHER|||||||0.146|||||||Chi-squared|||||||0.146
71897794|NCT00227877|143318926|SUPERIORITY||Adjusted Relative Risk Ratio|1.39|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|1.08|1.8|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.80|1.08|< 0.05
71897795|NCT00227877|143318927|SUPERIORITY||Adjusted Relative Risk Ratio|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.32|TWO_SIDED|95.0|0.34|1.42|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.42|0.34|.32
71897796|NCT00227877|143318928|SUPERIORITY||Adjusted Relative Risk Ratio|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.05|TWO_SIDED|95.0|0.99|3.27|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|||Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|3.27|.99|0.05
71897797|NCT00227877|143318929|SUPERIORITY||Adjusted Relative Risk Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.16||0.23|TWO_SIDED|95.0|0.53|1.16|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.|||1.16|.53|0.23
71897798|NCT00227877|143318930|SUPERIORITY||Adjusted Relative Risk Ratio|1.52|STANDARD_ERROR_OF_MEAN|0.34||0.07|TWO_SIDED|95.0|0.97|2.36|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.36|.97|.07
71846246|NCT02434328|143207426|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.0|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||10.4|-3.0|
71846247|NCT02434328|143207426|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-3.9|10.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||10.0|-3.9|
71846248|NCT02434328|143207427|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.6|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.4|-1.6|
71846249|NCT02434328|143207427|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-2.3|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.1|-2.3|
71846250|NCT02434328|143207427|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.|Week 12||2.2|-1.9|
71846251|NCT02434328|143207427|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.1|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||2.3|-2.1|
71846252|NCT02434328|143207427|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||3.3|-2.0|
71846253|NCT02434328|143207427|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.2|-3.0|
71846254|NCT02434328|143207427|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.0|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.3|-3.0|
71846255|NCT02434328|143207427|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-3.2|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.5|-3.2|
71846256|NCT02434328|143207427|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-2.3|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||3.3|-2.3|
71846257|NCT02434328|143207427|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-1.7|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.6|-1.7|
71846258|NCT02434328|143207427|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-2.7|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||3.4|-2.7|
71846259|NCT02434328|143207427|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.9|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-3.9|
71846260|NCT02434328|143207427|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.3|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||2.3|-4.3|
71846261|NCT02434328|143207427|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.8|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.9|-2.8|
71846262|NCT02434328|143207427|OTHER||Difference in proportions|0.6|||||TWO_SIDED|95.0|-2.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.2|-2.5|
71678132|NCT02833844|142874893|SUPERIORITY||treatment difference|71.9|||<|0.0001|TWO_SIDED|95.0|65.7|76.7||Based on Cochran-Mantel-Haenszel test stratified by statin use stratification factor. For testing, nonachievement was imputed for participants with a missing value.|Cochran-Mantel-Haenszel|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as a reference.|Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.||76.7|65.7|< 0.0001
71678133|NCT02833844|142874894|SUPERIORITY||treatment difference|-50.94|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-54.88|-46.99||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-46.99|-54.88|< 0.0001
71678134|NCT02833844|142874895|SUPERIORITY||treatment difference|-47.73|STANDARD_ERROR_OF_MEAN|1.72|<|0.0001|TWO_SIDED|95.0|-51.11|-44.35||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-44.35|-51.11|< 0.0001
71678135|NCT02833844|142874896|SUPERIORITY||treatment difference|-38.12|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|-41.3|-34.94||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-34.94|-41.30|< 0.0001
71814649|NCT04843930|143131136|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.79|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 229.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.79
71846263|NCT02434328|143207427|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.5|-2.7|
71846264|NCT02434328|143207427|OTHER||Difference in proportions|-0.9|||||TWO_SIDED|95.0|-4.2|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.6|-4.2|
71678136|NCT02833844|142874897|SUPERIORITY||treatment difference|-26.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-34.17|-19.4||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-19.40|-34.17|< 0.0001
71846265|NCT02434328|143207427|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-2.5|
71846266|NCT02434328|143207427|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-2.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.4|-2.5|
71897799|NCT00227877|143318931|SUPERIORITY||Adjusted Relative Risk Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.41||0.93|TWO_SIDED|95.0|0.42|2.21|||Regression, Logistic||Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||2.21|.42|.93
71897800|NCT00227877|143318932|SUPERIORITY||Adjusted Relative Risk Ratio|0.85|STANDARD_ERROR_OF_MEAN|0.5||0.78|TWO_SIDED|95.0|0.27|2.7|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.|||2.70|.27|.78
71897801|NCT00227877|143318933|SUPERIORITY||Adjusted Relative Risk Ratio|0.74|STANDARD_ERROR_OF_MEAN|0.15||0.13|TWO_SIDED|95.0|0.51|1.09|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.|||1.09|.51|.13
71678137|NCT02833844|142874898|SUPERIORITY||treatment difference|-22.46|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-31.03|-13.88||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-13.88|-31.03|< 0.0001
71678138|NCT02833844|142874899|SUPERIORITY||treatment difference|8.36|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|4.83|11.89||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||11.89|4.83|< 0.0001
71678139|NCT02833844|142874900|SUPERIORITY||treatment difference|-22.15|STANDARD_ERROR_OF_MEAN|4.01|<|0.0001|TWO_SIDED|95.0|-30.04|-14.26||Multiplicity adjustment was based on the combination of sequential testing, the fallback procedure, and the Hochberg procedure.|repeated measures linear effects model|Per protocol, the adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment difference uses placebo as the reference.|||-14.26|-30.04|< 0.0001
71678140|NCT01899742|142874901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|||<|0.001|TWO_SIDED|95.0|0.045|0.131|||Mixed Models Analysis|||||0.131|0.045|<0.001
71846267|NCT02434328|143207427|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.4|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.6|-2.4|
71846268|NCT02434328|143207427|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.1|-3.1|
71846269|NCT02434328|143207427|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-3.5|
71846270|NCT02434328|143207427|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.3|-3.8|
71846271|NCT02434328|143207427|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.8|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.3|-3.8|
71846272|NCT02434328|143207428|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-2.6|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-2.6|
71846273|NCT02434328|143207428|OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-2.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.1|-2.2|
71846274|NCT02434328|143207428|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-2.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-2.8|
71846275|NCT02434328|143207428|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-4.4|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||1.7|-4.4|
71846276|NCT02434328|143207428|OTHER||Difference in proportions|1.4|||||TWO_SIDED|95.0|-1.7|4.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.9|-1.7|
71846277|NCT02434328|143207428|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.9|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||2.8|-3.9|
71846278|NCT02434328|143207428|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.2|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||3.8|-3.2|
71897802|NCT00227877|143318934|SUPERIORITY||Adjusted Relative Risk Ratio|0.66|STANDARD_ERROR_OF_MEAN|0.11||0.66|TWO_SIDED|95.0|0.48|0.91|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||.91|.48|.66
71897803|NCT00227877|143318935|SUPERIORITY||Adjusted Relative Risk Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.13||0.35|TWO_SIDED|95.0|0.64|1.17||Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.|||1.17|.64|.35
71814650|NCT04843930|143131137|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.45|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 269.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.45
71814651|NCT04843930|143131138|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.02|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 236.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.02
71814652|NCT04843930|143131139|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.96|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 257.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.96
71814653|NCT04843930|143131140|SUPERIORITY||Mean Difference (Final Values)|2.78||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 262.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
71814654|NCT04843930|143131141|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.6|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 3, 227.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.60
71814655|NCT04843930|143131142|SUPERIORITY||Mean Difference (Final Values)|3.77||||0.06|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 89.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.06
71814656|NCT04843930|143131143|SUPERIORITY||Mean Difference (Final Values)|4.37||||0.04|TWO_SIDED|||||Threshold for statistical significance: p \< 0.05. Exploratory efficacy analysis - p-value not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom for the group x timepoint interaction: 1, 73.|Linear mixed effects interaction reported for group (intervention vs. waitlist control) and timepoint (all measures baseline to week 6).|"Linear Mixed Effects Model: main effects of arm group (intervention vs. waitlist control) and timepoint (all measures from baseline to week 6), arm group x timepoint interaction.~Modified intent-to-treat analysis with all participants who were randomized and completed at least the baseline study visit included in the analysis.~Participants in the intervention hypothesized to improve relative to waitlist control."||||0.04
71897804|NCT00227877|143318936|SUPERIORITY||Adjusted Relative Risk Ratio|0.63|STANDARD_ERROR_OF_MEAN|0.1|<|0.01|TWO_SIDED|95.0|0.46|0.87|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.87|.46|<.01
71897805|NCT00227877|143318937|SUPERIORITY||Adjusted Relative Risk Ratio|0.73|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.54|0.98|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.|||.98|.54|< 0.05
71814657|NCT00335257|143131144|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE|Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2||1.3|0.5|
71814658|NCT01987817|143131197|SUPERIORITY||Risk Difference (RD)|60.0|||<|0.0001|TWO_SIDED|95.0|35.0|79.0|||Fisher Exact|||||79|35|<0.0001
71814659|NCT01987817|143131198|SUPERIORITY||Treatment difference|0.912|||<|0.0001|TWO_SIDED|95.0|0.5184|1.3065||The p-value is based on the F-test for treatment effect adjusted for MTD from baseline (log10 mg). The p-value and confidence intervals are based on the normality assumption.|ANCOVA|Least squares means and 95% CIs based on ANCOVA model of change from baseline in MTD at Exit DBPCFC (terms for treatment \& MTD at baseline (log10 mg).||MTD for the baseline and Exit DBPCFC are transformed back to log10 scale before calculations. A value of 0.3 mg is substituted for subjects who could not tolerate the lowest DBPCFC dose before log10 transformation.||1.3065|0.5184|<0.0001
71814660|NCT01576718|143131246|SUPERIORITY_OR_OTHER|||||||0.0604||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.0604
71814661|NCT01576718|143131246|SUPERIORITY_OR_OTHER||LSM difference|0.072||||0.0637|TWO_SIDED|95.0|-0.004|0.149||Significance at the 0.05 level.|mixed model for repeated measures||Fp 400 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.149|-0.004|0.0637
71814662|NCT01576718|143131246|SUPERIORITY_OR_OTHER||LSM difference|0.056||||0.1585|TWO_SIDED|95.0|-0.022|0.133||Significance at the 0.05 level|mixed model for repeated measures||Fp 200 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.133|-0.022|0.1585
71814663|NCT01576718|143131246|SUPERIORITY_OR_OTHER||LSM difference|0.048||||0.2221|TWO_SIDED|95.0|-0.029|0.124||Significance at the 0.05 level|mixed model for repeated measures||Fp 100 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.124|-0.029|0.2221
71814664|NCT01576718|143131246|SUPERIORITY_OR_OTHER||LSM difference|0.006|||=|0.8694|TWO_SIDED|95.0|-0.07|0.083||Significance at the 0.05 level|mixed model for repeated measures||Fp 50 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||0.083|-0.070|=0.8694
71814665|NCT01576718|143131247|SUPERIORITY_OR_OTHER|||||||0.1512||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.1512
71814666|NCT01576718|143131247|SUPERIORITY_OR_OTHER||LSM difference|7.36||||0.2361|TWO_SIDED|95.0|-4.83|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.83|0.2361
71814667|NCT01576718|143131247|SUPERIORITY_OR_OTHER||LSM difference|7.78||||0.2169|TWO_SIDED|95.0|-4.59|20.15|||Regression, Linear|Significance at the 0.05 level||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.15|-4.59|0.2169
71814668|NCT01576718|143131247|SUPERIORITY_OR_OTHER||LSM difference|7.09||||0.2523|TWO_SIDED|95.0|-5.07|19.26||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.26|-5.07|0.2523
71814669|NCT01576718|143131247|SUPERIORITY_OR_OTHER||LSM difference|8.23||||0.1858|TWO_SIDED|95.0|-3.98|20.45||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||20.45|-3.98|0.1858
71846279|NCT02434328|143207428|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-3.8|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||3.5|-3.8|
71897806|NCT02522481|143318944|SUPERIORITY|||||||0.0896|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0896
71846280|NCT02434328|143207428|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-3.0|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||4.2|-3.0|
71897807|NCT02522481|143318944|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
71897808|NCT02026908|143318979|OTHER|Paired T- test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated with threshold of significance \<0.05.|t-test, 2 sided||A p-value was calculated. Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.0001
71678141|NCT01899742|142874902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.004|TWO_SIDED|95.0|0.024|0.122|||Mixed Models Analysis|||||0.122|0.024|0.004
71678142|NCT02195310|142874960|SUPERIORITY|||||||0.7007|||||||Fisher Exact Test (2-sided)|||||||0.7007
71678143|NCT01869699|142874979|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.002|TWO_SIDED|95.0|-0.76|-0.18|||ANCOVA|||We estimated that 20 patients per group would provide 80% power for detecting a difference in means of 0.6 degrees Celsius, with a pooled SD of 0.67 degrees, using a two group t test and a two sided alpha level of 0.05. A previous RCT of IV acetaminophen in healthy male volunteers with induced fever found a core temperature difference of 0.60 degrees with a common SD of 0.67 degrees Celsius.||-0.18|-0.76|0.002
71678144|NCT01869699|142874980|SUPERIORITY||Mean Difference (Final Values)|-6.0||||0.03|TWO_SIDED|95.0|-10.0|-1.0|||ANCOVA|||||-1|-10|0.03
71678145|NCT01869699|142874981|SUPERIORITY||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-25.0|-8.0|||ANCOVA|||||-8|-25|<0.001
71678146|NCT01869699|142874982|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.42|TWO_SIDED|95.0|-4.0|12.0|||ANCOVA|||||12|-4|0.42
71814670|NCT01576718|143131248|SUPERIORITY_OR_OTHER|||||||0.2879||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.||||0.2879
71678147|NCT01869699|142874983|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.002|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||||-0.3|-1|0.002
71846281|NCT02434328|143207428|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.1|-2.4|
71846282|NCT02434328|143207428|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-1.1|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||6.5|-1.1|
71678148|NCT01869699|142874984|SUPERIORITY||Mean Difference (Final Values)|-24.0||||0.001|TWO_SIDED|95.0|-38.0|-10.0|||ANCOVA|||||-10|-38|0.001
71678149|NCT01869699|142874985|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.02|TWO_SIDED|95.0|-15.0|-1.0|||ANCOVA|||||-1|-15|0.02
71678150|NCT02447497|142875008|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.51|4.1|||Paired t-test|||48 hours post treatment time point. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||4.10|0.51|<0.0001
71846283|NCT02434328|143207428|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-4.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.3|-4.0|
71846284|NCT02434328|143207428|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.8|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.7|-2.8|
71846285|NCT02434328|143207428|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.8|5.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||5.5|-2.8|
71846286|NCT02434328|143207428|OTHER||Difference of proportions|1.0|||||TWO_SIDED|95.0|-2.6|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||4.7|-2.6|
71846287|NCT02434328|143207428|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||4.3|-4.0|
71846288|NCT02434328|143207428|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.2|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||3.6|-4.2|
71846289|NCT02434328|143207428|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.0|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||3.7|-4.0|
71846290|NCT02434328|143207428|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.7|-3.5|
71846291|NCT02434328|143207428|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.4|-4.5|
71897809|NCT02026908|143318980|OTHER|Paired t test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
71897810|NCT02026908|143318981|OTHER|Paired T test|p value|0.05||||0.0001|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated with threshold of significance \<0.05.|||||0.0001
71678151|NCT02447497|142875008|SUPERIORITY||Mean Difference (Final Values)|2.37|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|0.6|5.75|||Paired t-test|||48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.75|0.60|0.0001
71678152|NCT02447497|142875008|SUPERIORITY||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.23||0.0001|TWO_SIDED|95.0|0.17|3.75|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||3.75|0.17|0.0001
71897811|NCT02026908|143318982|OTHER|Paired T Test|p value|0.05||||0.0001|TWO_SIDED|||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided|||||||0.0001
71897812|NCT02026908|143318983|OTHER|Paired T test|p value|0.05||||0.008|TWO_SIDED|0.0||||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|t-test, 2 sided||P value was calculated and a value of \<0.05 was considered significant. A p-value was calculated. Comments: Pretreatment (baseline) values for each parameter are compared to post-treatment values in a paired fashion.|||||0.008
71897813|NCT01240811|143318990|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||ANOVA|||||||0.80
71897814|NCT01240811|143318990|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||ANOVA|||||||0.97
71897815|NCT01240811|143318991|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||Difference in paired change in Nugent score from baseline to 2 months||||0.08
71678153|NCT02447497|142875008|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.33||0.0001|TWO_SIDED|95.0|0.13|5.04|||Paired t-test|||72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.||5.04|0.13|0.0001
71678154|NCT02017912|142875012|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.5567||0.7208|TWO_SIDED|95.0|-1.321|0.92|||Mixed Models Analysis|||||0.920|-1.321|0.7208
71678155|NCT02017912|142875013|SUPERIORITY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.881||0.641|TWO_SIDED|95.0|-2.187|1.36|||Mixed Models Analysis|||||1.360|-2.187|0.6410
71897816|NCT01240811|143318992|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Change in quantity of H2O2 producing Lactobacilli species by qPCR||||0.46
71678156|NCT01322035|142875014|EQUIVALENCE|95% confidence limits from standard deviation of the mean were used as the equivalence.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|95% confidence limits from standard deviation||||||<0.05
71897817|NCT01240811|143318992|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Change in quantity of Garnerella vaginalis species by qPCR||||0.62
71897818|NCT01543490|143318993|SUPERIORITY|Statistical hypotheses testing for the primary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05.|Risk Difference (RD)|8.5|STANDARD_ERROR_OF_MEAN|4.03||0.0354|TWO_SIDED|95.0|0.2|16.6||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% confidence interval (CI) was calculated.|||16.6|0.2|0.0354
71897819|NCT01543490|143318994|SUPERIORITY|Statistical hypotheses testing for the secondary efficacy endpoint was 2-sided and performed using a significance (alpha) level of 0.05, and missing data imputed using the LOCF approach.|Risk Difference (RD)|7.1|STANDARD_ERROR_OF_MEAN|4.07||0.1036|TWO_SIDED|95.0|-1.3|15.0||The p-value was from a 2-sided Fisher's exact test.|Fisher Exact|The point estimate of treatment effect (ISV-305 compared with Vehicle) was reported using Fisher's exact test.|The risk difference was obtained by taking the difference in proportions (ISV-305 minus Vehicle). A 2-sided exact unconditional 95% CI was calculated.|||15.0|-1.3|0.1036
71897820|NCT03918642|143319015|SUPERIORITY||Mean Difference (Net)|-1.59|||<|0.001|TWO_SIDED|95.0|-2.35|-0.83|||Mixed Models Analysis|||||-0.83|-2.35|<0.001
71678157|NCT00732758|142875018|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||ANCOVA|adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.||||||0.003
71897821|NCT03918642|143319016|SUPERIORITY||Mean Difference (Net)|-1.01||||0.01|TWO_SIDED|95.0|-1.78|-0.24|||Mixed Models Analysis|||||-0.24|-1.78|0.01
71678158|NCT00732758|142875019|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|unadjusted p-values||||||0.51
71678159|NCT00732758|142875020|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71678160|NCT00732758|142875021|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
71897822|NCT03918642|143319017|SUPERIORITY||Mean Difference (Net)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||||0.45|0.12|<0.001
71897823|NCT03918642|143319018|SUPERIORITY||Mean Difference (Net)|-1.42||||0.14|TWO_SIDED|95.0|-3.3|0.46|||Mixed Models Analysis|||||0.46|-3.30|0.14
71846292|NCT02434328|143207428|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-3.6|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-3.6|
71846293|NCT02434328|143207428|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-4.5|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-4.5|
71846294|NCT02434328|143207428|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.7|2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||2.6|-5.7|
71846295|NCT02434328|143207428|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-4.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||3.2|-4.9|
71846296|NCT02434328|143207429|OTHER||Difference in proportions|-0.2|||||TWO_SIDED|95.0|-3.5|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||3.5|-3.5|
71846297|NCT02434328|143207429|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.4|-4.4|
71846298|NCT02434328|143207429|OTHER||Difference in proportions|-1.0|||||TWO_SIDED|95.0|-5.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.1|-5.0|
71846299|NCT02434328|143207429|OTHER||Difference in proportions|1.9|||||TWO_SIDED|95.0|-1.9|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.2|-1.9|
71846300|NCT02434328|143207429|OTHER||Difference in proportions|3.7|||||TWO_SIDED|95.0|-0.4|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||7.8|-0.4|
71846301|NCT02434328|143207429|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-1.3|7.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Number of subjects with \>=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24||7.8|-1.3|
71846302|NCT02434328|143207429|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.7|7.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||7.3|-1.7|
71846303|NCT02434328|143207429|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.2|5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||5.9|-3.2|
71846304|NCT02434328|143207429|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-0.7|8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||8.3|-0.7|
71846305|NCT02434328|143207429|OTHER||Difference in proportions|1.0|||||TWO_SIDED|95.0|-3.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||5.6|-3.8|
71846306|NCT02434328|143207429|OTHER||Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.4|7.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||7.0|-1.4|
71897824|NCT03918642|143319019|SUPERIORITY||Mean Difference (Net)|0.21||||0.85|TWO_SIDED|95.0|-1.99|2.42|||Mixed Models Analysis|||||2.42|-1.99|0.85
71897825|NCT03918642|143319020|SUPERIORITY||Mean Difference (Net)|-3.06||||0.03|TWO_SIDED|95.0|-5.88|-0.25|||Mixed Models Analysis|||||-0.25|-5.88|0.03
71897826|NCT03918642|143319021|SUPERIORITY||Mean Difference (Net)|-2.39||||0.02|TWO_SIDED|95.0|-4.33|-0.45|||Mixed Models Analysis|||||-0.45|-4.33|0.02
71897827|NCT03918642|143319022|SUPERIORITY||Mean Difference (Net)|-2.49||||0.006|TWO_SIDED|95.0|-4.3|-0.68|||Mixed Models Analysis|||||-0.68|-4.30|0.006
71897828|NCT03918642|143319023|SUPERIORITY||Mean Difference (Net)|-1.95||||0.11|TWO_SIDED|95.0|-4.34|0.45|||Mixed Models Analysis|||||0.45|-4.34|0.11
71897829|NCT03918642|143319024|SUPERIORITY||Mean Difference (Net)|-4.39||||0.03|TWO_SIDED|95.0|-8.44|-0.34|||Mixed Models Analysis|||||-0.34|-8.44|0.03
71678161|NCT01508130|142875034|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.6451|TWO_SIDED|95.0|0.78|1.49|||Wald residual chi-square test||Due to the non-interventional study design, the Cox model included a propensity score as a covariate (incorporated important demographics and baseline characteristics) to account for the potential imbalance between treatment groups.|||1.49|0.78|0.6451
71678162|NCT01508130|142875034|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.02||||0.8826|TWO_SIDED|95.0|0.78|1.34|||Wald residual chi-square test||Without Propensity Score as a Covariate.|||1.34|0.78|0.8826
71678163|NCT01508130|142875035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7695|TWO_SIDED|95.0|0.58|1.49|||Multiple Logistic Regression||A multiple logistic regression model including a propensity score as a covariate (incorporated important demographics and baseline characteristics) was used for the treatment comparison.|||1.49|0.58|0.7695
71678164|NCT01508130|142875035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.2594|TWO_SIDED|95.0|0.84|1.92|||Multiple Logistic Regression||Without Propensity Score as a Covariate|||1.92|0.84|0.2594
71678165|NCT01508130|142875042|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.03||||0.9156|TWO_SIDED|95.0|0.64|1.64|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.64|0.64|0.9156
71678166|NCT01508130|142875043|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.5649|TWO_SIDED|95.0|0.57|1.36|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.|||1.36|0.57|0.5649
71678167|NCT01252563|142875064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71897830|NCT03918642|143319025|SUPERIORITY||Mean Difference (Net)|-3.76||||0.07|TWO_SIDED|95.0|-7.83|0.32|||Mixed Models Analysis|||||0.32|-7.83|0.07
71897831|NCT03918642|143319026|SUPERIORITY||Mean Difference (Net)|1.23||||0.005|TWO_SIDED|95.0|0.36|2.1|||Mixed Models Analysis|||||2.10|0.36|0.005
71897832|NCT03918642|143319027|SUPERIORITY||Mean Difference (Net)|0.95||||0.17|TWO_SIDED|95.0|-0.4|2.29|||Mixed Models Analysis|||||2.29|-0.40|0.17
71678168|NCT01252563|142875064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71678169|NCT01252563|142875064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71678170|NCT01252563|142875064|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.||||<0.001
71678171|NCT01252563|142875065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71678172|NCT01252563|142875065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71678173|NCT01252563|142875065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71678174|NCT01252563|142875065|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.||||<0.001
71678175|NCT01252563|142875068|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Complication. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events."||||<0.001
71678176|NCT01252563|142875069|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events."||||<0.001
71678177|NCT01252563|142875070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Chi-squared|||"The risk factor tested was angina pectoris as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events."||||0.036
71897833|NCT03918642|143319028|SUPERIORITY||Mean Difference (Net)|-1.85||||0.11|TWO_SIDED|95.0|-4.14|0.44|||Mixed Models Analysis|||||0.44|-4.14|0.11
71897834|NCT03918642|143319029|SUPERIORITY||Mean Difference (Net)|-2.57||||0.11|TWO_SIDED|95.0|-5.73|0.6|||Mixed Models Analysis|||||0.60|-5.73|0.11
71897835|NCT03918642|143319030|SUPERIORITY||Mean Difference (Net)|-0.78||||0.33|TWO_SIDED|95.0|-2.33|0.78|||Mixed Models Analysis|||||0.78|-2.33|0.33
71897836|NCT03918642|143319031|SUPERIORITY||Mean Difference (Net)|-0.3||||0.69|TWO_SIDED|95.0|-1.74|1.14|||Mixed Models Analysis|||||1.14|-1.74|0.69
71897837|NCT03918642|143319032|SUPERIORITY||Mean Difference (Net)|1.46|||<|0.001|TWO_SIDED|95.0|0.77|2.15|||Mixed Models Analysis|||||2.15|0.77|<0.001
71897838|NCT03918642|143319033|SUPERIORITY||Mean Difference (Net)|1.24|||<|0.001|TWO_SIDED|95.0|0.62|1.86|||Mixed Models Analysis|||||1.86|0.62|<0.001
71897839|NCT03918642|143319034|SUPERIORITY||Odds Ratio (OR)|21.54|||<|0.001|TWO_SIDED|95.0|4.66|99.56|||Mixed Models Analysis|||||99.56|4.66|<0.001
71897840|NCT03918642|143319035|SUPERIORITY||Odds Ratio (OR)|7.24||||0.006|TWO_SIDED|95.0|1.74|30.06|||Mixed Models Analysis|||||30.06|1.74|0.006
71897841|NCT03918642|143319036|SUPERIORITY||Odds Ratio (OR)|11.77||||0.002|TWO_SIDED|95.0|2.38|58.25|||Mixed Models Analysis|||||58.25|2.38|0.002
71897842|NCT03918642|143319037|SUPERIORITY||Odds Ratio (OR)|6.58||||0.05|TWO_SIDED|95.0|0.99|43.67|||Mixed Models Analysis|||||43.67|0.99|0.05
71897843|NCT03918642|143319038|SUPERIORITY||Odds Ratio (OR)|13.93||||0.06|TWO_SIDED|95.0|0.86|225.44|||Mixed Models Analysis|||||225.44|0.86|0.06
71897844|NCT03918642|143319039|SUPERIORITY||Odds Ratio (OR)|5.61||||0.22|TWO_SIDED|95.0|0.35|89.3|||Mixed Models Analysis|||||89.30|0.35|0.22
71678178|NCT01252563|142875071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Chi-squared|||"The risk factor tested was dyslipidaemia as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events."||||0.020
71678179|NCT01252563|142875072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Chi-squared|||"The risk factor tested was antihypertensive as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events."||||0.049
71678180|NCT01252563|142875073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||Chi-squared|||"The risk factor tested was ARB as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events."||||0.043
71678181|NCT01252563|142875074|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was diabetes mellitus as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy."||||<0.001
71678182|NCT01252563|142875075|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was chronic kidney disease as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy."||||<0.001
71678183|NCT01252563|142875076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Chi-squared|||"The risk factor tested was myocardial infarction as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy."||||0.039
71678184|NCT01252563|142875077|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was metabolic syndrome as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy."||||<0.001
71678185|NCT01252563|142875078|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The risk factor tested was ambulatory SBP at baseline. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines."||||<0.001
71678186|NCT01252563|142875080|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71814671|NCT01576718|143131248|SUPERIORITY_OR_OTHER||LSM difference|7.56||||0.2166|TWO_SIDED|95.0|-4.45|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||19.56|-4.45|0.2166
71814672|NCT01576718|143131248|SUPERIORITY_OR_OTHER||LSM difference|4.03||||0.5167|TWO_SIDED|95.0|-8.17|16.23||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||16.23|-8.17|0.5167
71897845|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||<0.0001
71897846|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
71897847|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
71678187|NCT01252563|142875080|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71678188|NCT01252563|142875080|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71814673|NCT01576718|143131248|SUPERIORITY_OR_OTHER||LSM difference|2.99||||0.6258|TWO_SIDED|95.0|-9.06|15.05||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||15.05|-9.06|0.6258
71814674|NCT01576718|143131248|SUPERIORITY_OR_OTHER||LSM difference|0.39||||0.9487|TWO_SIDED|95.0|-11.6|12.39||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.||12.39|-11.60|0.9487
71814675|NCT01576718|143131249|SUPERIORITY_OR_OTHER|||||||0.0341||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0341
71814676|NCT01576718|143131249|SUPERIORITY_OR_OTHER|||||||0.034||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0340
71814677|NCT01576718|143131249|SUPERIORITY_OR_OTHER|||||||0.0058||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0058
71897848|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
71897849|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
71897850|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.0001
71897851|NCT00500149|143319040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
71897852|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose||||< 0.0001
71897853|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose||||<0.0001
71897854|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose||||<0.0001
71897855|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose||||<0.0001
71897856|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose||||<0.0001
71897857|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose||||<0.001
71897858|NCT00500149|143319041|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose||||<0.0001
71897859|NCT00521339|143319069|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71897860|NCT00521339|143319070|SUPERIORITY_OR_OTHER_LEGACY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
71897861|NCT00521339|143319071|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71897862|NCT00521339|143319072|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71897863|NCT00521339|143319073|SUPERIORITY_OR_OTHER_LEGACY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
71897864|NCT00521339|143319074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||||||0.242
71897865|NCT00521339|143319075|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329|||||||Wilcoxon (Mann-Whitney)|||||||0.329
71897866|NCT00521339|143319076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.130
71897867|NCT00521339|143319078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.008
71897868|NCT00521339|143319079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
71897869|NCT00521339|143319080|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71897870|NCT00521339|143319082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71897871|NCT00521339|143319083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
71897872|NCT00521339|143319084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71897873|NCT00521339|143319085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71897874|NCT00521339|143319086|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71897875|NCT00521339|143319087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||||||0.031
71897876|NCT00521339|143319088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
71897877|NCT00521339|143319089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539|||||||Wilcoxon (Mann-Whitney)|||||||0.539
71897878|NCT00521339|143319090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
71897879|NCT00521339|143319091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||Wilcoxon (Mann-Whitney)|||||||0.339
71897880|NCT00521339|143319092|SUPERIORITY_OR_OTHER_LEGACY|||||||0.898|||||||Wilcoxon (Mann-Whitney)|||||||0.898
71897881|NCT00521339|143319093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
71814678|NCT01576718|143131249|SUPERIORITY_OR_OTHER|||||||0.0018||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.0018
71897882|NCT00089843|143319104|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|3.2|||<|0.0001|TWO_SIDED|95.0|1.8|4.6||This p value was for the effect of Actonel (risedronate) on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||4.6|1.8|<0.0001
71678189|NCT01252563|142875080|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.||||<0.001
71814679|NCT01576718|143131249|SUPERIORITY_OR_OTHER|||||||0.1006||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo||||0.1006
71814680|NCT01576718|143131250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.88116|TWO_SIDED|95.0|-11.12|12.91||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||12.91|-11.12|0.88116
71814681|NCT01576718|143131250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.98||||0.05977|TWO_SIDED|95.0|-22.64|0.68||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||0.68|-22.64|0.05977
71814682|NCT01576718|143131250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74||||0.90426|TWO_SIDED|95.0|-13.02|11.54||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||11.54|-13.02|0.90426
71814683|NCT01576718|143131250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.38||||0.4731|TWO_SIDED|95.0|-16.57|7.82||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).||7.82|-16.57|0.47310
71814684|NCT01576718|143131257|SUPERIORITY_OR_OTHER||LSM difference|0.019|||=|0.6161|TWO_SIDED|95.0|-0.057|0.096||0.05 level of significance.|mixed model for repeated measures|||||0.096|-0.057|=0.6161
71814685|NCT01576718|143131257|SUPERIORITY_OR_OTHER||LSM difference|0.004||||0.9245|TWO_SIDED|95.0|-0.973|0.08||0.05 level of significance.|mixed model for repeated measures|||||0.080|-0.973|0.9245
71814686|NCT01576718|143131257|SUPERIORITY_OR_OTHER||LSM difference|-0.008||||0.8434|TWO_SIDED|95.0|-0.083|0.068||0.05 level of significance.|mixed model for repeated measures|||||0.068|-0.083|0.8434
71814687|NCT01576718|143131257|SUPERIORITY_OR_OTHER||LSM difference|-0.047||||0.2241|TWO_SIDED|95.0|-0.122|0.029||0.05 level of significance.|mixed model for repeated measures|||||0.029|-0.122|0.2241
71814688|NCT01576718|143131257|SUPERIORITY_OR_OTHER||LSM difference|-0.053||||0.1822|TWO_SIDED|95.0|-0.13|0.025||0.05 level of significance.|mixed model for repeated measures|||||0.025|-0.130|0.1822
71814689|NCT01576718|143131258|SUPERIORITY_OR_OTHER||LSM difference|-5.56||||0.3568|TWO_SIDED|95.0|-17.42|6.29||0.05 level of significance.|Regression, Linear|||||6.29|-17.42|0.3568
71814690|NCT01576718|143131258|SUPERIORITY_OR_OTHER||LSM difference|-5.68||||0.3531|TWO_SIDED|95.0|-17.67|6.32||0.05 level of significance.|Regression, Linear|||||6.32|-17.67|0.3531
71814691|NCT01576718|143131258|SUPERIORITY_OR_OTHER||LSM difference|-6.58||||0.2724|TWO_SIDED|95.0|-18.35|5.19||0.05 level of significance.|Regression, Linear|||||5.19|-18.35|0.2724
71814692|NCT01576718|143131258|SUPERIORITY_OR_OTHER||LSM difference|-5.11|||=|0.3964|TWO_SIDED|95.0|-16.95|6.72||0.05 level of significance.|Regression, Linear|||||6.72|-16.95|=0.3964
71814693|NCT01576718|143131258|SUPERIORITY_OR_OTHER||LSM difference|-13.45||||0.0296|TWO_SIDED|95.0|-25.57|-1.33||0.05 level of significance.|Regression, Linear|||||-1.33|-25.57|0.0296
71814694|NCT01576718|143131259|SUPERIORITY_OR_OTHER||LSM difference|-0.69||||0.9101|TWO_SIDED|95.0|-12.59|11.22||0.05 level of significance.|Regression, Linear|||||11.22|-12.59|0.9101
71814695|NCT01576718|143131259|SUPERIORITY_OR_OTHER||LSM difference|-4.51||||0.4634|TWO_SIDED|95.0|-16.6|7.57||0.05 level of significance.|Regression, Linear|||||7.57|-16.6|0.4634
71897883|NCT00089843|143319104|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-0.6||||0.41|TWO_SIDED|95.0|-2.0|0.8||This p value was for the effect of testosterone on bone mineral density of the spine.|Factorial analysis|||Factorial analysis||0.8|-2.0|0.41
71678190|NCT01252563|142875081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71814696|NCT01576718|143131259|SUPERIORITY_OR_OTHER||LSM difference|-5.88||||0.3333|TWO_SIDED|95.0|-17.8|6.05||0.05 level of significance.|Regression, Linear|||||6.05|-17.8|0.3333
71678191|NCT01252563|142875081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71814697|NCT01576718|143131259|SUPERIORITY_OR_OTHER||LSM difference|-8.19||||0.1763|TWO_SIDED|95.0|-20.06|3.69||0.05 level of significance.|Regression, Linear|||||3.69|-20.06|0.1763
71814698|NCT01576718|143131259|SUPERIORITY_OR_OTHER||Slope|-9.05||||0.1469|TWO_SIDED|95.0|-21.3|3.19||0.05 level of significance.|Regression, Linear|||||3.19|-21.3|0.1469
71814699|NCT01742364|143131260|SUPERIORITY_OR_OTHER|||||||0.475|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.475
71814700|NCT01742364|143131260|SUPERIORITY_OR_OTHER|||||||0.187|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).||||0.187
71814701|NCT01742364|143131262|SUPERIORITY_OR_OTHER|||||||0.205|||||||Wilcoxon (Mann-Whitney)|||||||0.205
71814702|NCT01742364|143131263|SUPERIORITY_OR_OTHER|||||||0.325|||||||Wilcoxon (Mann-Whitney)|||||||0.325
71814703|NCT01742364|143131264|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71814704|NCT01742364|143131264|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.130
71846307|NCT02434328|143207429|OTHER||Difference in proportions|-0.7|||||TWO_SIDED|95.0|-5.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||3.7|-5.1|
71846308|NCT02434328|143207429|OTHER||Difference in proportions|2.1|||||TWO_SIDED|95.0|-2.5|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||6.7|-2.5|
71846309|NCT02434328|143207429|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||6.4|-2.8|
71846310|NCT02434328|143207429|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-3.6|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||5.8|-3.6|
71846311|NCT02434328|143207429|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.0|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||5.4|-4.0|
71846312|NCT02434328|143207429|OTHER||Difference in proportions|1.8|||||TWO_SIDED|95.0|-2.8|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.4|-2.8|
71846313|NCT02434328|143207429|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.3|5.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||5.7|-4.3|
71846314|NCT02434328|143207429|OTHER||Difference in proportions|0.7|||||TWO_SIDED|95.0|-4.4|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.8|-4.4|
71846315|NCT02434328|143207429|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-6.0|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||3.6|-6.0|
71846316|NCT02434328|143207429|OTHER||Difference in proportions|-0.4|||||TWO_SIDED|95.0|-5.2|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.5|-5.2|
71846317|NCT02434328|143207429|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.7|3.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.6|-5.7|
71846318|NCT02434328|143207429|OTHER||Difference in proportions|-1.5|||||TWO_SIDED|95.0|-6.5|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.4|-6.5|
71678192|NCT01252563|142875081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71897884|NCT00089843|143319105|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-41.0||||0.002|TWO_SIDED|95.0||||This p value was for the effect of Actonel (risedronate).|Factorial analysis|||Factorial analysis||||0.002
71897885|NCT00089843|143319105|SUPERIORITY_OR_OTHER_LEGACY||Percent change between 0 and 12 months|-11.0||||0.39||95.0||||This p value was for the effect of testosterone.|Factorial analysis|||Factorial analysis||||0.39
71678193|NCT01252563|142875081|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.||||<0.001
71678194|NCT03403751|142875092|SUPERIORITY|||||||0.649|||||||Chi-squared|||||||0.649
71678195|NCT03403751|142875095|SUPERIORITY|||||||0.871|||||||Chi-squared|||||||0.871
71678196|NCT03403751|142875096|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
71846319|NCT02434328|143207429|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-5.1|4.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.8|-5.1|
71846320|NCT02434328|143207430|OTHER||Difference in proportions|-4.0|||||TWO_SIDED|95.0|-9.2|1.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.6|-9.2|
71897886|NCT04003155|143319124|SUPERIORITY||LSMean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.69|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Least squares Mean (LSM), Standard error (SE), Confidence interval (CI), Mixed model repeated measures (MMRM), Change from Baseline (CFB), Dependent variable (dv), Treatment (tr), Week (wk), Baseline (bl), Weight (wt)||-1.05|-2.69|<0.001
71897887|NCT04003155|143319124|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.42|<|0.001||95.0|-2.89|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.25|-2.89|<0.001
71897888|NCT04003155|143319124|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
71897889|NCT04003155|143319124|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
71897890|NCT04003155|143319125|SUPERIORITY||LSMean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.44|<|0.001||95.0|-3.25|-1.52||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.52|-3.25|<0.001
71897891|NCT04003155|143319125|SUPERIORITY||LSMean Difference|-2.55|STANDARD_ERROR_OF_MEAN|0.43|<|0.001||95.0|-3.4|-1.7||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-1.70|-3.40|<0.001
71897892|NCT04003155|143319125|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
71897893|NCT04003155|143319125|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
71897894|NCT04003155|143319126|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.012||95.0|-0.27|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.03|-0.27|0.012
71897895|NCT04003155|143319126|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.002||95.0|-0.3|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.07|-0.30|0.002
71897896|NCT04003155|143319126|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
71897897|NCT04003155|143319126|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
71897898|NCT04003155|143319127|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002||95.0|-0.39|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.09|-0.39|0.002
71897899|NCT04003155|143319127|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.007||95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||-0.06|-0.35|0.007
71897900|NCT04003155|143319127|SUPERIORITY|||||||0.012|||||||Hochberg|||||||0.012
71897901|NCT04003155|143319127|SUPERIORITY|||||||0.007|||||||Hochberg|||||||0.007
71897902|NCT04003155|143319128|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.8||0.489||95.0|-2.0|1.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||1.0|-2.0|0.489
71897903|NCT04003155|143319128|SUPERIORITY||LSMean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.155||95.0|-2.5|0.4||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||||0.4|-2.5|0.155
71678197|NCT03403751|142875097|SUPERIORITY|||||||0.448|||||||Wilcoxon (Mann-Whitney)|||||||0.448
71678198|NCT03403751|142875098|SUPERIORITY|||||||0.579|||||||Wilcoxon (Mann-Whitney)|||||||0.579
71678199|NCT03403751|142875099|SUPERIORITY|||||||0.227|||||||Wilcoxon (Mann-Whitney)|||||||0.227
71678200|NCT03403751|142875102|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71678201|NCT03403751|142875103|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71678202|NCT03403751|142875104|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71678203|NCT03403751|142875105|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71678204|NCT01820572|142875108|SUPERIORITY|difference between belatacept and CNI|Difference in proportions|0.9|||||TWO_SIDED|95.0|-8.6|10.4||||||||10.4|-8.6|
71678205|NCT01820572|142875109|SUPERIORITY|difference between belatacept and CNI|Difference in Proportions|-0.4|||||TWO_SIDED|95.0|-9.9|9.0||||||||9.0|-9.9|
71678206|NCT00387010|142875141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.3223|TWO_SIDED|95.0|-4.64|1.54|||t-test, 2 sided|||||1.54|-4.64|0.3223
71814705|NCT01742364|143131265|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71814706|NCT01742364|143131265|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||||||0.003
71814707|NCT00682643|143131266|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.395
71814708|NCT00682643|143131267|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square|||||||0.342
71814709|NCT02424591|143131307|SUPERIORITY_OR_OTHER|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
71814710|NCT02424591|143131308|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71814711|NCT02424591|143131309|SUPERIORITY_OR_OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71814712|NCT01991821|143131312|SUPERIORITY|||||||0.093||||||The complete response of the primary efficacy analysis occurred in 95 patients (56.2%; 95% confidence interval \[CI\] 48.4 - 63.8%) in the APD421 group and 83 patients (46.6%; 95% CI 39.1- 54.2%) in the placebo group|Chi-squared, Corrected|Pearson square test with Yates's continuity correction and with the two- sided significance level of 5%||The primary efficacy analysis was a complete response which is defined as protection from PONV1, which was absence of any episode of emesis, significant nausea or use of rescue medication with the first 24 hours post-operatively.||||0.093
71814713|NCT01991821|143131313|SUPERIORITY|||||||0.059||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.059
71814714|NCT01991821|143131314|SUPERIORITY|||||||0.053||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.053
71814715|NCT01991821|143131315|SUPERIORITY|||||||0.26||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.26
71814716|NCT01991821|143131316|SUPERIORITY|||||||0.06||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.06
71814717|NCT01991821|143131317|SUPERIORITY|||||||0.079||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected|||||||0.079
71897904|NCT04003155|143319129|SUPERIORITY||LSMean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.53|-1.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-1.09|-2.53|<0.001
71814718|NCT01991821|143131318|SUPERIORITY|||||||0.096|||||||Chi-squared, Corrected|||||||0.096
71814719|NCT04581200|143131319|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.61|TWO_SIDED|95.0|-1.63|2.8|||t-test, 2 sided|||||2.80|-1.63|0.61
71814720|NCT04581200|143131320|OTHER|This is an exploratory pilot trial|Mean Difference (Final Values)|0.21||||0.89|TWO_SIDED|95.0|-2.66|3.08|||t-test, 2 sided|||||3.08|-2.66|0.89
71678207|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|7.44||0.97|TWO_SIDED|95.0|-14.3|14.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||14.9|-14.3|0.97
71678208|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|6.15||0.58|TWO_SIDED|95.0|-8.6|15.5|||ANCOVA|||||15.5|-8.6|0.58
71678209|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|6.13||0.33|TWO_SIDED|95.0|-6.1|18.0|||ANCOVA|||||18.0|-6.1|0.33
71678210|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|17.6|STANDARD_ERROR_OF_MEAN|6.2||0.005|TWO_SIDED|95.0|5.4|29.8|||ANCOVA|||||29.8|5.4|0.005
71678211|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|18.2|STANDARD_ERROR_OF_MEAN|6.1||0.003|TWO_SIDED|95.0|6.2|30.2|||ANCOVA|||||30.2|6.2|0.003
71678212|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|21.7|STANDARD_ERROR_OF_MEAN|7.37||0.003|TWO_SIDED|95.0|7.2|36.1|||ANCOVA|||||36.1|7.2|0.003
71678213|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|26.3|STANDARD_ERROR_OF_MEAN|7.32|<|0.001|TWO_SIDED|95.0|11.9|40.7|||ANCOVA|||||40.7|11.9|<0.001
71678214|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.0|STANDARD_ERROR_OF_MEAN|8.46||0.2|TWO_SIDED|95.0|-5.6|27.6|||ANCOVA|||||27.6|-5.6|0.20
71678215|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|20.5|STANDARD_ERROR_OF_MEAN|8.43||0.015|TWO_SIDED|95.0|4.0|37.1|||ANCOVA|||||37.1|4.0|0.015
71678216|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.4|STANDARD_ERROR_OF_MEAN|8.43||0.008|TWO_SIDED|95.0|5.9|39.0|||ANCOVA|||||39.0|5.9|0.008
71678217|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.0|STANDARD_ERROR_OF_MEAN|7.32||0.003|TWO_SIDED|95.0|7.6|36.3|||ANCOVA|||||36.3|7.6|0.003
71678218|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|22.2|STANDARD_ERROR_OF_MEAN|8.46||0.009|TWO_SIDED|95.0|5.6|38.8|||ANCOVA|||||38.8|5.6|0.009
71678219|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|25.4|STANDARD_ERROR_OF_MEAN|7.35|<|0.001|TWO_SIDED|95.0|11.0|39.8|||ANCOVA|||||39.8|11.0|<0.001
71678220|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|27.9|STANDARD_ERROR_OF_MEAN|7.34|<|0.001|TWO_SIDED|95.0|13.5|42.3|||ANCOVA|||||42.3|13.5|<0.001
71678221|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|39.6|STANDARD_ERROR_OF_MEAN|7.39|<|0.001|TWO_SIDED|95.0|25.1|54.1|||ANCOVA|||||54.1|25.1|<0.001
71814721|NCT04581200|143131321|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.81|TWO_SIDED|95.0|-2.58|3.3|||t-test, 2 sided|||||3.30|-2.58|0.81
71814722|NCT04581200|143131322|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.75|TWO_SIDED|95.0|-2.98|2.14|||t-test, 2 sided|||||2.14|-2.98|0.75
71814723|NCT04581200|143131323|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.45|TWO_SIDED|95.0|-0.57|0.74|||t-test, 2 sided|||||0.74|-0.57|0.45
71814724|NCT04581200|143131324|SUPERIORITY||Mean Difference (Final Values)|0.002||||0.98|TWO_SIDED|95.0|-0.13|0.13|||t-test, 2 sided|||||0.13|-0.13|0.98
71814725|NCT04581200|143131325|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
71814726|NCT04581200|143131326|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
71814727|NCT01625923|143131341|OTHER|T-test comparing GCSI-DD scores before/after intervention||||||0.06|||||||t-test, 2 sided|||||||.06
71814728|NCT04750655|143131356|OTHER|||||||1|||||||Kruskal-Wallis|||Used the Kruskal-Wallis (nonparametric one-way ANOVA), comparing all 3 arms. Note that for each individual, a single number (normalized read) is obtained.||||1
71814729|NCT01216163|143131361|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|17.68|||<|0.001|TWO_SIDED|95.0|13.08|22.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference(Ibuprofen sodium - placebo) and 95 percent(%) confidence interval(CI):based on LS means from Analysis of Variance(ANOVA).Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:Ibuprofen sodium(IBU Na) versus(vs) Placebo(PBO), IBU Na vs Acetaminophen(APAP), APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||22.27|13.08|<0.001
71814730|NCT01216163|143131361|SUPERIORITY_OR_OTHER||LS mean difference|4.96||||0.01|TWO_SIDED|95.0|1.21|8.72||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium - Acetaminophen) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||8.72|1.21|0.010
71814731|NCT01216163|143131361|SUPERIORITY_OR_OTHER||LS mean difference|12.71|||<|0.001|TWO_SIDED|95.0|8.12|17.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Acetaminophen - Placebo) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||17.30|8.12|<0.001
71814732|NCT01216163|143131362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.84|||<|0.001|TWO_SIDED|95.0|5.13|27.36||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||27.36|5.13|<0.001
71678222|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean DIfference|40.2|STANDARD_ERROR_OF_MEAN|7.31|<|0.001|TWO_SIDED|95.0|25.8|54.5|||ANCOVA|||||54.5|25.8|<0.001
71678223|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|43.6|STANDARD_ERROR_OF_MEAN|8.42|<|0.001|TWO_SIDED|95.0|27.1|60.1|||ANCOVA|||||60.1|27.1|<0.001
71678224|NCT01340027|142875298|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|48.3|STANDARD_ERROR_OF_MEAN|8.35|<|0.001|TWO_SIDED|95.0|31.9|64.7|||ANCOVA|||||64.7|31.9|<0.001
71678225|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.366||0.062|TWO_SIDED|95.0|-1.4|0.03|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.03|-1.40|0.062
71678226|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.302||0.91|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA|||||0.56|-0.63|0.91
71678227|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.302||0.2|TWO_SIDED|95.0|-0.98|0.2|||ANCOVA|||||0.20|-0.98|0.20
71814733|NCT01216163|143131362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.468|TWO_SIDED|95.0|0.81|1.6||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||1.60|0.81|0.468
71814734|NCT01216163|143131362|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.43|||<|0.001|TWO_SIDED|95.0|4.5|24.17||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.||24.17|4.50|<0.001
71678228|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.305||0.96|TWO_SIDED|95.0|-0.62|0.58|||ANCOVA|||||0.58|-0.62|0.96
71897905|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-1.25|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-1.97|-0.53||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.53|-1.97|<0.001
71678229|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.007|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||||-0.22|-1.39|0.007
71678230|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.363||0.016|TWO_SIDED|95.0|-1.59|-0.16|||ANCOVA|||||-0.16|-1.59|0.016
71678231|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.36||0.007|TWO_SIDED|95.0|-1.68|-0.27|||ANCOVA|||||-0.27|-1.68|0.007
71897906|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.75|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.19|-2.75|<0.001
71897907|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-2.6|-1.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-1.05|-2.60|<0.001
71897908|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.79|-1.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.19|-2.79|<0.001
71897909|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.9|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-1.31|-2.90|<0.001
71897910|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.07|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.87|-1.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.27|-2.87|<0.001
71897911|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.98|-1.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-1.39|-2.98|<0.001
71897912|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.92|-1.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.30|-2.92|<0.001
71678232|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.417||0.91|TWO_SIDED|95.0|-0.87|0.77|||ANCOVA|||||0.77|-0.87|0.91
71678233|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.415||0.76|TWO_SIDED|95.0|-0.94|0.69|||ANCOVA|||||0.69|-0.94|0.76
71897913|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-3.19|-1.59||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-1.59|-3.19|<0.001
71897914|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.95|-1.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.25|-2.95|<0.001
71678234|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.416||0.99|TWO_SIDED|95.0|-0.82|0.81|||ANCOVA|||||0.81|-0.82|0.99
71678235|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.361||0.77|TWO_SIDED|95.0|-0.82|0.6|||ANCOVA|||||0.60|-0.82|0.77
71678236|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.79|STANDARD_ERROR_OF_MEAN|0.417||0.058|TWO_SIDED|95.0|-1.61|0.03|||ANCOVA|||||0.03|-1.61|0.058
71678237|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.362||0.69|TWO_SIDED|95.0|-0.85|0.57|||ANCOVA|||||0.57|-0.85|0.69
71678238|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.362||0.17|TWO_SIDED|95.0|-1.21|0.21|||ANCOVA|||||0.21|-1.21|0.17
71678239|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.364||0.73|TWO_SIDED|95.0|-0.84|0.59|||ANCOVA|||||0.59|-0.84|0.73
71678240|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|0.361||0.012|TWO_SIDED|95.0|-1.62|-0.2|||ANCOVA|||||-0.20|-1.62|0.012
71897915|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.27|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.11|-1.42||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-1.42|-3.11|<0.001
71897916|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.25|-1.54||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.54|-3.25|<0.001
71897917|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.39|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.23|-1.55||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-1.55|-3.23|<0.001
71814735|NCT01216163|143131363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|14.06|||<|0.001|TWO_SIDED|95.0|6.02|32.8||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||32.80|6.02|<0.001
71814736|NCT01216163|143131363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.323|TWO_SIDED|95.0|0.84|1.68||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.68|0.84|0.323
71814737|NCT01216163|143131363|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|11.81|||<|0.001|TWO_SIDED|95.0|5.06|27.59||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||27.59|5.06|<0.001
71814738|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.53|||<|0.001|TWO_SIDED|95.0|0.24|0.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.83|0.24|<0.001
71814739|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.101|TWO_SIDED|95.0|-0.04|0.44||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.44|-0.04|0.101
71814740|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.029|TWO_SIDED|95.0|0.03|0.62||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.62|0.03|0.029
71814741|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.44|||<|0.001|TWO_SIDED|95.0|1.01|1.87||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.87|1.01|<0.001
71814742|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.24||||0.178|TWO_SIDED|95.0|-0.11|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.11|0.178
71814743|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.2|||<|0.001|TWO_SIDED|95.0|0.77|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.63|0.77|<0.001
71814744|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|2.07|||<|0.001|TWO_SIDED|95.0|1.64|2.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.49|1.64|<0.001
71814745|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.44||||0.014|TWO_SIDED|95.0|0.09|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.78|0.09|0.014
71814746|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.63|||<|0.001|TWO_SIDED|95.0|1.21|2.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.06|1.21|<0.001
71814747|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|2.25|||<|0.001|TWO_SIDED|95.0|1.79|2.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.70|1.79|<0.001
71814748|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.055|TWO_SIDED|95.0|-0.01|0.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.74|-0.01|0.055
71897918|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-2.93|-1.22||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.22|-2.93|<0.001
71678241|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.414||0.018|TWO_SIDED|95.0|-1.8|-0.17|||ANCOVA|||||-0.17|-1.80|0.018
71678242|NCT01340027|142875299|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.412||0.009|TWO_SIDED|95.0|-1.89|-0.28|||ANCOVA|||||-0.28|-1.89|0.009
71678243|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.46||0.51|TWO_SIDED|95.0|-1.0|0.82||Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.82|-1.00|0.51
71678244|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.355||0.21|TWO_SIDED|95.0|-0.57|0.83|||Stratified Rank ANCOVA|||||0.83|-0.57|0.21
71678245|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.361||0.89|TWO_SIDED|95.0|-0.68|0.74|||Stratified Rank ANCOVA|||||0.74|-0.68|0.89
71814749|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.88|||<|0.001|TWO_SIDED|95.0|1.43|2.34||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.34|1.43|<0.001
71814750|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|2.31|||<|0.001|TWO_SIDED|95.0|1.8|2.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.83|1.80|<0.001
71814751|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.51||||0.019|TWO_SIDED|95.0|0.08|0.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.93|0.08|0.019
71897919|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.0|-1.31||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-1.31|-3.00|<0.001
71897920|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.21|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.05|-1.37||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.37|-3.05|<0.001
71678246|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.365||0.001|TWO_SIDED|95.0|-1.06|0.38||P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.|Stratified Rank ANCOVA|||||0.38|-1.06|0.001
71814752|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||<|0.001|TWO_SIDED|95.0|1.29|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.29|<0.001
71814753|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.66|1.53|<0.001
71814754|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.59||||0.013|TWO_SIDED|95.0|0.13|1.05||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.05|0.13|0.013
71814755|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.51|||<|0.001|TWO_SIDED|95.0|0.95|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.95|<0.001
71897921|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.16|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.98|-1.33||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-1.33|-2.98|<0.001
71678247|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.397||0.058|TWO_SIDED|95.0|-1.04|0.52|||Stratified Rank ANCOVA|||||0.52|-1.04|0.058
71897922|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.34|-1.62||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.62|-3.34|<0.001
71897923|NCT04003155|143319129|SUPERIORITY||LSMean Difference|-2.45|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.3|-1.6||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-1.60|-3.30|<0.001
71897924|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
71897925|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.006|TWO_SIDED|95.0|-0.17|-0.03||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-0.03|-0.17|0.006
71897926|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.003|TWO_SIDED|95.0|-0.24|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.05|-0.24|0.003
71897927|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.25|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-0.06|-0.25|0.002
71897928|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.27|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.05|-0.27|0.004
71897929|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.003|TWO_SIDED|95.0|-0.28|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-0.06|-0.28|0.003
71897930|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.05|-0.29|0.006
71897931|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.004|TWO_SIDED|95.0|-0.29|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-0.06|-0.29|0.004
71897932|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.33|-0.07||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.07|-0.33|0.003
71897933|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.38|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-0.13|-0.38|<0.001
71678248|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.395||0.15|TWO_SIDED|95.0|-0.17|1.38|||Stratified Rank ANCOVA|||||1.38|-0.17|0.15
71678249|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.417||0.41|TWO_SIDED|95.0|-0.91|0.73|||Stratified Rank ANCOVA|||||0.73|-0.91|0.41
71897934|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.11|-0.37|<0.001
71897935|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.39|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-0.13|-0.39|<0.001
71897936|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.15||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.15|-0.41|<0.001
71897937|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.37|-0.11||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-0.11|-0.37|<0.001
71897938|NCT04003155|143319130|SUPERIORITY||MMRM|-0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.41|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.12|-0.41|<0.001
71897939|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.004|TWO_SIDED|95.0|-0.35|-0.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-0.06|-0.35|0.004
71897940|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.13||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.13|-0.43|<0.001
71897941|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.37|-0.08||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-0.08|-0.37|0.002
71897942|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.43|-0.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.12|-0.43|<0.001
71897943|NCT04003155|143319130|SUPERIORITY||LSMean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-0.09|-0.40|0.002
71897944|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-15.52|STANDARD_ERROR_OF_MEAN|3.29|<|0.001|TWO_SIDED|95.0|-21.99|-9.06||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-9.06|-21.99|<0.001
71897945|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-12.22|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-18.69|-5.74||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 1||-5.74|-18.69|<0.001
71897946|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-17.3|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-24.32|-10.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-10.27|-24.32|<0.001
71897947|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|3.57|<|0.001|TWO_SIDED|95.0|-25.3|-11.29||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 2||-11.29|-25.30|<0.001
71897948|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-18.13|STANDARD_ERROR_OF_MEAN|3.63|<|0.001|TWO_SIDED|95.0|-25.25|-11.0||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-11.00|-25.25|<0.001
71678250|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.554||0.44|TWO_SIDED|95.0|-0.88|1.3|||Stratified Rank ANCOVA|||||1.30|-0.88|0.44
71678251|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.505||0.85|TWO_SIDED|95.0|-0.95|1.04|||Stratified Rank ANCOVA|||||1.04|-0.95|0.85
71678252|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.533||0.83|TWO_SIDED|95.0|-1.36|0.74|||Stratified Rank ANCOVA|||||0.74|-1.36|0.83
71678253|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.444||0.56|TWO_SIDED|95.0|-0.8|0.95|||Stratified Rank ANCOVA|||||0.95|-0.80|0.56
71678254|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.534||0.48|TWO_SIDED|95.0|-1.07|1.03|||Stratified Rank ANCOVA|||||1.03|-1.07|0.48
71678255|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.443||0.13|TWO_SIDED|95.0|-0.67|1.07|||Stratified Rank ANCOVA|||||1.07|-0.67|0.13
71897949|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-21.19|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-28.29|-14.09||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 3||-14.09|-28.29|<0.001
71897950|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-16.75|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-24.24|-9.26||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-9.26|-24.24|<0.001
71897951|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-21.05|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-28.5|-13.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 4||-13.61|-28.50|<0.001
71897952|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-17.57|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-25.02|-10.12||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-10.12|-25.02|<0.001
71897953|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-21.78|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-29.18|-14.39||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 5||-14.39|-29.18|<0.001
71897954|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-18.39|STANDARD_ERROR_OF_MEAN|3.89|<|0.001|TWO_SIDED|95.0|-26.03|-10.75||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-10.75|-26.03|<0.001
71678256|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.448||0.62|TWO_SIDED|2.0|-0.78|0.99|||Stratified Rank ANCOVA|||||0.99|-0.78|0.62
71678257|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.454||0.34|TWO_SIDED|95.0|-1.16|0.63|||Stratified Rank ANCOVA|||||0.63|-1.16|0.34
71678258|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.472||0.24|TWO_SIDED|95.0|-1.12|0.74|||Stratified Rank ANCOVA|||||0.74|-1.12|0.24
71678259|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|0.475||0.88|TWO_SIDED|95.0|-0.26|1.61|||Stratified Rank ANCOVA|||||1.61|-0.26|0.88
71678260|NCT01340027|142875300|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.494||0.83|TWO_SIDED|95.0|-0.99|0.95|||Stratified Rank ANCOVA|||||0.95|-0.99|0.83
71897955|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-23.83|STANDARD_ERROR_OF_MEAN|3.85|<|0.001|TWO_SIDED|95.0|-31.39|-16.27||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 6||-16.27|-31.39|<0.001
71897956|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-18.29|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-26.33|-10.25||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-10.25|-26.33|<0.001
71678261|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.42|TWO_SIDED|95.0|0.69|2.39|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.39|0.69|0.42
71678262|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.48|TWO_SIDED|95.0|0.72|2.0|||Regression, Logistic|||||2.00|0.72|0.48
71678263|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.69|TWO_SIDED|95.0|0.67|1.83|||Regression, Logistic|||||1.83|0.67|0.69
71678264|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.95|TWO_SIDED|95.0|0.61|1.69|||Regression, Logistic|||||1.69|0.61|0.95
71678265|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.015|TWO_SIDED|95.0|1.14|3.21|||Regression, Logistic|||||3.21|1.14|0.015
71678266|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.023|TWO_SIDED|95.0|1.11|3.84|||Regression, Logistic|||||3.84|1.11|0.023
71678267|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.54||||0.16|TWO_SIDED|95.0|0.84|2.84|||Regression, Logistic|||||2.84|0.84|0.16
71678268|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.45|1.76|||Regression, Logistic|||||1.76|0.45|0.73
71814756|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.97|||<|0.001|TWO_SIDED|95.0|1.39|2.56||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.56|1.39|<0.001
71814757|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.63||||0.01|TWO_SIDED|95.0|0.15|1.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.10|0.15|0.010
71814758|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.35|||<|0.001|TWO_SIDED|95.0|0.77|1.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.93|0.77|<0.001
71814759|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.54|||<|0.001|TWO_SIDED|95.0|0.95|2.14||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.14|0.95|<0.001
71814760|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.088|TWO_SIDED|95.0|-0.06|0.91||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.91|-0.06|0.088
71814761|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.52|1.71||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.71|0.52|<0.001
71814762|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||<|0.001|TWO_SIDED|95.0|0.85|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.07|0.85|<0.001
71814763|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.47||||0.061|TWO_SIDED|95.0|-0.02|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|-0.02|0.061
71814764|NCT01216163|143131364|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.002|TWO_SIDED|95.0|0.38|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|0.38|0.002
71814765|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.31|||<|0.001|TWO_SIDED|95.0|0.13|0.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.49|0.13|<0.001
71846321|NCT02434328|143207430|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-8.1|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||3.7|-8.1|
71846322|NCT02434328|143207430|OTHER||Difference in proportions|-2.5|||||TWO_SIDED|95.0|-8.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.5|-8.4|
71678269|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88||||0.7|TWO_SIDED|95.0|0.45|1.72|||Regression, Logistic|||||1.72|0.45|0.70
71678270|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.26|TWO_SIDED|95.0|0.74|2.99|||Regression, Logistic|||||2.99|0.74|0.26
71678271|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.63|2.04|||Regression, Logistic|||||2.04|0.63|0.69
71678272|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.29|TWO_SIDED|95.0|0.73|2.89|||Regression, Logistic|||||2.89|0.73|0.29
71678273|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.31|TWO_SIDED|95.0|0.75|2.45|||Regression, Logistic|||||2.45|0.75|0.31
71678274|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.25|||Regression, Logistic|||||2.25|0.70|0.45
71814766|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.06||||0.387|TWO_SIDED|95.0|-0.08|0.21||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.21|-0.08|0.387
71814767|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.007|TWO_SIDED|95.0|0.07|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.42|0.07|0.007
71814768|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.89|||<|0.001|TWO_SIDED|95.0|0.64|1.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.15|0.64|<0.001
71814769|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.019|TWO_SIDED|95.0|0.04|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.46|0.04|0.019
71814770|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.64|||<|0.001|TWO_SIDED|95.0|0.38|0.9||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.90|0.38|<0.001
71814771|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.3|||<|0.001|TWO_SIDED|95.0|1.01|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.59|1.01|<0.001
71814772|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.33||||0.006|TWO_SIDED|95.0|0.09|0.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.57|0.09|0.006
71814773|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.97|||<|0.001|TWO_SIDED|95.0|0.68|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.26|0.68|<0.001
71814774|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.12|1.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.74|1.12|<0.001
71814775|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.32||||0.014|TWO_SIDED|95.0|0.07|0.58||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.58|0.07|0.014
71846323|NCT02434328|143207430|OTHER||Difference in proportions|0.3|||||TWO_SIDED|95.0|-5.4|6.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||6.7|-5.4|
71846324|NCT02434328|143207430|OTHER||Difference in proportions|-2.2|||||TWO_SIDED|95.0|-8.2|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||4.0|-8.2|
71897957|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-21.41|STANDARD_ERROR_OF_MEAN|4.04|<|0.001|TWO_SIDED|95.0|-29.35|-13.48||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 7||-13.48|-29.35|<0.001
71678275|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.64|TWO_SIDED|95.0|0.64|2.07|||Regression, Logistic|||||2.07|0.64|0.64
71678276|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.16||||0.013|TWO_SIDED|95.0|1.18|3.94|||Regression, Logistic|||||3.94|1.18|0.013
71678277|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.017|TWO_SIDED|95.0|1.16|4.66|||Regression, Logistic|||||4.66|1.16|0.017
71678278|NCT01340027|142875303|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.74||||0.11|TWO_SIDED|95.0|0.88|3.45|||Regression, Logistic|||||3.45|0.88|0.11
71678279|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.64||||0.52|TWO_SIDED|95.0|0.16|2.56|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.56|0.16|0.52
71678280|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.67||||0.48|TWO_SIDED|95.0|0.23|1.99|||Regression, Logistic|||||1.99|0.23|0.48
71678281|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95||||0.93|TWO_SIDED|95.0|0.32|2.81|||Regression, Logistic|||||2.81|0.32|0.93
71678282|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.12||||0.013|TWO_SIDED|95.0|1.47|25.6|||Regression, Logistic|||||25.60|1.47|0.013
71678283|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.49||||0.031|TWO_SIDED|95.0|1.17|25.77|||Regression, Logistic|||||25.77|1.17|0.031
71678284|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.84||||0.059|TWO_SIDED|95.0|0.95|15.58|||Regression, Logistic|||||15.58|0.95|0.059
71846325|NCT02434328|143207430|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.0|3.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||3.3|-9.0|
71846326|NCT02434328|143207430|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-9.3|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.5|-9.3|
71897958|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-20.16|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.14|-12.19||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-12.19|-28.14|<0.001
71678285|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.91||||0.36|TWO_SIDED|95.0|0.48|7.58|||Regression, Logistic|||||7.58|0.48|0.36
71678286|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.34||||0.26|TWO_SIDED|95.0|0.05|2.17|||Regression, Logistic|||||2.17|0.05|0.26
71678287|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.43||||0.33|TWO_SIDED|95.0|0.08|2.31|||Regression, Logistic|||||2.31|0.08|0.33
71678288|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.94|TWO_SIDED|95.0|0.17|6.68|||Regression, Logistic|||||6.68|0.17|0.94
71678289|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.29|TWO_SIDED|95.0|0.09|2.02|||Regression, Logistic|||||2.02|0.09|0.29
71678290|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28||||0.15|TWO_SIDED|95.0|0.05|1.6|||Regression, Logistic|||||1.60|0.05|0.15
71678291|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.29||||0.11|TWO_SIDED|95.0|0.06|1.34|||Regression, Logistic|||||1.34|0.06|0.11
71678292|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.26|TWO_SIDED|95.0|0.09|1.89|||Regression, Logistic|||||1.89|0.09|0.26
71678293|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.67||||0.28|TWO_SIDED|95.0|0.44|16.17|||Regression, Logistic|||||16.17|0.44|0.28
71678294|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.39||||0.36|TWO_SIDED|95.0|0.37|15.46|||Regression, Logistic|||||15.46|0.37|0.36
71678295|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.68||||0.56|TWO_SIDED|95.0|0.29|9.72|||Regression, Logistic|||||9.72|0.29|0.56
71897959|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-21.17|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-29.04|-13.3||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 8||-13.30|-29.04|<0.001
71678296|NCT01340027|142875305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.83||||0.84|TWO_SIDED|95.0|0.15|4.76|||Regression, Logistic|||||4.76|0.15|0.84
71678297|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61||||0.48|TWO_SIDED|95.0|0.16|2.38|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.38|0.16|0.48
71678298|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.58|TWO_SIDED|95.0|0.25|2.17|||Regression, Logistic|||||2.17|0.25|0.58
71678299|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.93|TWO_SIDED|95.0|0.34|3.28|||Regression, Logistic|||||3.28|0.34|0.93
71678300|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|12.16||||0.023|TWO_SIDED|95.0|1.4|105.3|||Regression, Logistic|||||105.30|1.40|0.023
71678301|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.48||||0.042|TWO_SIDED|95.0|1.08|83.24|||Regression, Logistic|||||83.24|1.08|0.042
71678302|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.03||||0.047|TWO_SIDED|95.0|1.03|79.19|||Regression, Logistic|||||79.19|1.03|0.047
71678303|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.23|TWO_SIDED|95.0|0.52|14.9|||Regression, Logistic|||||14.90|0.52|0.23
71678304|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.058|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.058
71678305|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.18||||0.15|TWO_SIDED|95.0|0.02|1.87|||Regression, Logistic|||||1.87|0.02|0.15
71678306|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.99|||Regression, Logistic|||||5.99|0.04|0.55
71678307|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.16||||0.11|TWO_SIDED|95.0|0.02|1.48|||Regression, Logistic|||||1.48|0.02|0.11
71678308|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1||||0.054|TWO_SIDED|95.0|0.01|1.05|||Regression, Logistic|||||1.05|0.01|0.054
71678309|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.12||||0.059|TWO_SIDED|95.0|0.01|1.08|||Regression, Logistic|||||1.08|0.01|0.059
71678310|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.17||||0.12|TWO_SIDED|95.0|0.02|1.58|||Regression, Logistic|||||1.58|0.02|0.12
71678311|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.64|TWO_SIDED|95.0|0.11|35.46|||Regression, Logistic|||||35.46|0.11|0.64
71678312|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.76|TWO_SIDED|95.0|0.09|27.42|||Regression, Logistic|||||27.42|0.09|0.76
71678313|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.49||||0.79|TWO_SIDED|95.0|0.08|26.47|||Regression, Logistic|||||26.47|0.08|0.79
71678314|NCT01340027|142875306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.46||||0.55|TWO_SIDED|95.0|0.04|5.77|||Regression, Logistic|||||5.77|0.04|0.55
71678315|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.495||0.25|TWO_SIDED|95.0|-1.24|0.71||All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.||0.71|-1.24|0.25
71678316|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.383||0.35|TWO_SIDED|95.0|-0.7|0.81|||Stratified Rank ANCOVA|||||0.81|-0.70|0.35
71678317|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.371||1|TWO_SIDED|95.0|-0.74|0.72|||Stratified Rank ANCOVA|||||0.72|-0.74|1.0
71678318|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.377||0.003|TWO_SIDED|95.0|-1.08|0.41|||Stratified Rank ANCOVA|||||0.41|-1.08|0.003
71678319|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.413||0.12|TWO_SIDED|95.0|-1.04|0.59|||Stratified Rank ANCOVA|||||0.59|-1.04|0.12
71678320|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.405||0.24|TWO_SIDED|95.0|-0.21|1.38|||Stratified Rank ANCOVA|||||1.38|-0.21|0.24
71678321|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.435||0.54|TWO_SIDED|95.0|-0.94|0.78|||Stratified Rank ANCOVA|||||0.78|-0.94|0.54
71678322|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.95|TWO_SIDED|95.0|-1.1|1.22|||Stratified Rank ANCOVA|||||1.22|-1.10|0.95
71678323|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.552||0.74|TWO_SIDED|95.0|-1.11|1.07|||Stratified Rank ANCOVA|||||1.07|-1.11|0.74
71678324|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.57||0.89|TWO_SIDED|95.0|-1.43|0.82|||Stratified Rank ANCOVA|||||0.82|-1.43|0.89
71678325|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.487||0.82|TWO_SIDED|95.0|-0.96|0.96|||Stratified Rank ANCOVA|||||0.96|-0.96|0.82
71678326|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.593||0.58|TWO_SIDED|95.0|-1.44|0.9|||Stratified Rank ANCOVA|||||0.90|-1.44|0.58
71678327|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.5||0.46|TWO_SIDED|95.0|-0.93|1.04|||Stratified Rank ANCOVA|||||1.04|-0.93|0.46
71678328|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.49||0.95|TWO_SIDED|95.0|-0.97|0.96|||Stratified Rank ANCOVA|||||0.96|-0.97|0.95
71678329|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.499||0.18|TWO_SIDED|95.0|-1.32|0.65|||Stratified Rank ANCOVA|||||0.65|-1.32|0.18
71678330|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.517||0.21|TWO_SIDED|95.0|-1.24|0.8|||Stratified Rank ANCOVA|||||0.80|-1.24|0.21
71678331|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.516||0.72|TWO_SIDED|95.0|-0.43|1.6|||Stratified Rank ANCOVA|||||1.60|-0.43|0.72
71678332|NCT01340027|142875307|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.541||0.92|TWO_SIDED|95.0|-1.15|0.98|||Stratified Rank ANCOVA|||||0.98|-1.15|0.92
71678333|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.26|STANDARD_ERROR_OF_MEAN|0.412||0.002|TWO_SIDED|95.0|-2.06|-0.45|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||-0.45|-2.06|0.002
71678334|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.34||0.16|TWO_SIDED|95.0|-1.15|0.19|||ANCOVA|||||0.19|-1.15|0.16
71678335|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-1.91|-0.57|||ANCOVA|||||-0.57|-1.91|<0.001
71678336|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.343||0.001|TWO_SIDED|95.0|-1.8|-0.46|||ANCOVA|||||-0.46|-1.80|0.001
71678337|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.338|<|0.001|TWO_SIDED|95.0|-2.03|-0.7|||ANCOVA|||||-0.70|-2.03|<0.001
71897960|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-16.67|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-24.73|-8.61||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-8.61|-24.73|<0.001
71897961|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-18.89|STANDARD_ERROR_OF_MEAN|4.05|<|0.001|TWO_SIDED|95.0|-26.84|-10.94||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 9||-10.94|-26.84|<0.001
71897962|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-17.88|STANDARD_ERROR_OF_MEAN|4.01|<|0.001|TWO_SIDED|95.0|-25.77|-9.99||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-9.99|-25.77|<0.001
71897963|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-19.5|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-27.28|-11.72||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 10||-11.72|-27.28|<0.001
71897964|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-20.32|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-28.3|-12.35||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-12.35|-28.30|<0.001
71897965|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-22.14|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-30.0|-14.28||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 11||-14.28|-30.00|<0.001
71678338|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.409||0.017|TWO_SIDED|95.0|-1.78|-0.18|||ANCOVA|||||-0.18|-1.78|0.017
71897966|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-20.08|STANDARD_ERROR_OF_MEAN|4.13|<|0.001|TWO_SIDED|95.0|-28.19|-11.96||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-11.96|-28.19|<0.001
71897967|NCT04003155|143319131|SUPERIORITY||LSMean Difference|-24.18|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-32.16|-16.2||LSM, SE, CI, \& p-values come from MMRM analysis of covariance model with CFB as dv \& trt group, wk \& smoking status as factors, with bl measurement \& bl wt as covariates, as well as an interaction of trt by wk \& interaction of bl measurement by wk.|MMRM|||Week 12||-16.20|-32.16|<0.001
71897968|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.245|||<|0.001|TWO_SIDED|95.0|1.823|5.999||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.999|1.823|<0.001
71897969|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.964|||<|0.001|TWO_SIDED|95.0|1.658|5.497||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 1||5.497|1.658|<0.001
71897970|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.187||||0.001|TWO_SIDED|95.0|1.363|3.549||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||3.549|1.363|0.001
71678339|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.405||0.004|TWO_SIDED|95.0|-1.98|-0.39|||ANCOVA|||||-0.39|-1.98|0.004
71678340|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.469||0.53|TWO_SIDED|95.0|-0.63|1.22|||ANCOVA|||||1.22|-0.63|0.53
71897971|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.847|||<|0.001|TWO_SIDED|95.0|1.786|4.601||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||4.601|1.786|<0.001
71897972|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.096||||0.002|TWO_SIDED|95.0|1.326|3.345||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||3.345|1.326|0.002
71897973|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.333|||<|0.001|TWO_SIDED|95.0|2.121|5.302||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||5.302|2.121|<0.001
71897974|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.061||||0.001|TWO_SIDED|95.0|1.323|3.233||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||3.233|1.323|0.001
71897975|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.025|||<|0.001|TWO_SIDED|95.0|1.947|4.746||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.746|1.947|<0.001
71897976|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.363|3.357||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||3.357|1.363|<0.001
71897977|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.223|||<|0.001|TWO_SIDED|95.0|2.067|5.08||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||5.080|2.067|<0.001
71846327|NCT02434328|143207430|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.6|2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||2.8|-9.6|
71846328|NCT02434328|143207430|OTHER||Difference in proportions|-3.7|||||TWO_SIDED|95.0|-9.6|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||2.2|-9.6|
71846329|NCT02434328|143207430|OTHER||Difference in proportions|-1.7|||||TWO_SIDED|95.0|-7.6|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||4.2|-7.6|
71846330|NCT02434328|143207430|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.5|5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.0|-7.5|
71846331|NCT02434328|143207430|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-5.4|6.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||6.1|-5.4|
71846332|NCT02434328|143207430|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.7|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||4.5|-7.7|
71846333|NCT02434328|143207430|OTHER||Difference in proportions|-1.9|||||TWO_SIDED|95.0|-7.7|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||4.0|-7.7|
71846334|NCT02434328|143207430|OTHER||Difference in proportions|-4.7|||||TWO_SIDED|95.0|-10.8|1.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.4|-10.8|
71846335|NCT02434328|143207430|OTHER||Difference in proportions|-2.8|||||TWO_SIDED|95.0|-8.9|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||3.2|-8.9|
71897978|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.049||||0.002|TWO_SIDED|95.0|1.317|3.21||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||3.210|1.317|0.002
71897979|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.097|||<|0.001|TWO_SIDED|95.0|1.994|4.858||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||4.858|1.994|<0.001
71678341|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.468||0.85|TWO_SIDED|95.0|-0.83|1.01|||ANCOVA|||||1.01|-0.83|0.85
71897980|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|1.984||||0.002|TWO_SIDED|95.0|1.28|3.097||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||3.097|1.280|0.002
71897981|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.062|||<|0.001|TWO_SIDED|95.0|1.977|4.788||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||4.788|1.977|<0.001
71897982|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.748|||<|0.001|TWO_SIDED|95.0|1.774|4.294||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||4.294|1.774|<0.001
71897983|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.379|||<|0.001|TWO_SIDED|95.0|1.536|3.712||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||3.712|1.536|<0.001
71897984|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.051||||0.001|TWO_SIDED|95.0|1.329|3.186||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||3.186|1.329|0.001
71846336|NCT02434328|143207430|OTHER||Difference in proportions|-3.1|||||TWO_SIDED|95.0|-9.5|2.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||2.9|-9.5|
71846337|NCT02434328|143207430|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-7.9|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.5|-7.9|
71846338|NCT02434328|143207430|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.1|-8.1|
71846339|NCT02434328|143207430|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-5.6|6.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||6.6|-5.6|
71846340|NCT02434328|143207430|OTHER||Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.3|3.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||3.8|-8.3|
71897985|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.701|||<|0.001|TWO_SIDED|95.0|1.75|4.204||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||4.204|1.750|<0.001
71897986|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.725|||<|0.001|TWO_SIDED|95.0|1.742|4.306||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||4.306|1.742|<0.001
71897987|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.921|||<|0.001|TWO_SIDED|95.0|2.505|6.214||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.214|2.505|<0.001
71897988|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.104|||<|0.001|TWO_SIDED|95.0|1.363|3.27||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.270|1.363|<0.001
71897989|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|2.953|||<|0.001|TWO_SIDED|95.0|1.912|4.602||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.602|1.912|<0.001
71897990|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|1.894||||0.005|TWO_SIDED|95.0|1.22|2.961||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||2.961|1.220|0.005
71897991|NCT04003155|143319132|SUPERIORITY||Odds Ratio (OR)|3.156|||<|0.001|TWO_SIDED|95.0|2.035|4.944||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||4.944|2.035|<0.001
71897992|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|3.158||||0.322|TWO_SIDED|95.0|0.398|64.304||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||64.304|0.398|0.322
71897993|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|3.925||||0.225|TWO_SIDED|95.0|0.569|77.353||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 2||77.353|0.569|0.225
71897994|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|6.334||||0.089|TWO_SIDED|95.0|1.064|120.422||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||120.422|1.064|0.089
71897995|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|5.026||||0.143|TWO_SIDED|95.0|0.797|96.916||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 3||96.916|0.797|0.143
71897996|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|1.257||||0.711|TWO_SIDED|95.0|0.37|4.468||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||4.468|0.370|0.711
71897997|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|1.57||||0.441|TWO_SIDED|95.0|0.508|5.328||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 4||5.328|0.508|0.441
71897998|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|5.351||||0.032|TWO_SIDED|95.0|1.383|35.172||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||35.172|1.383|0.032
71897999|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|3.059||||0.175|TWO_SIDED|95.0|0.693|21.086||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 5||21.086|0.693|0.175
71898000|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|4.225||||0.071|TWO_SIDED|95.0|1.039|28.29||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||28.290|1.039|0.071
71898001|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|5.22||||0.035|TWO_SIDED|95.0|1.348|34.323||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 6||34.323|1.348|0.035
71898002|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|7.064||||0.011|TWO_SIDED|95.0|1.912|45.64||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||45.640|1.912|0.011
71678342|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.468||0.84|TWO_SIDED|95.0|-1.01|0.83|||ANCOVA|||||0.83|-1.01|0.84
71846341|NCT02434328|143207430|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-7.4|4.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||4.5|-7.4|
71846342|NCT02434328|143207430|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-6.5|5.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||5.8|-6.5|
71846343|NCT02434328|143207430|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-8.1|4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.1|-8.1|
71846344|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-17.7|STANDARD_ERROR_OF_MEAN|7.57|||TWO_SIDED|95.0|-32.6|-2.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||-2.9|-32.6|
71846345|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-29.5|STANDARD_ERROR_OF_MEAN|8.18|||TWO_SIDED|95.0|-45.6|-13.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||-13.4|-45.6|
71846346|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-30.3|STANDARD_ERROR_OF_MEAN|8.45|||TWO_SIDED|95.0|-46.9|-13.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||-13.7|-46.9|
71846347|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|9.51|||TWO_SIDED|95.0|-58.9|-21.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||-21.6|-58.9|
71846348|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|9.12|||TWO_SIDED|95.0|-20.9|15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||15.0|-20.9|
71846349|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-47.8|STANDARD_ERROR_OF_MEAN|9.42|||TWO_SIDED|95.0|-66.3|-29.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||-29.3|-66.3|
71846350|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||-5.4|-42.0|
71846351|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-33.7|STANDARD_ERROR_OF_MEAN|9.54|||TWO_SIDED|95.0|-52.4|-15.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||-15.0|-52.4|
71846352|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-30.4|STANDARD_ERROR_OF_MEAN|8.94|||TWO_SIDED|95.0|-48.0|-12.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||-12.9|-48.0|
71846353|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-44.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|95.0|-63.5|-25.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||-25.9|-63.5|
71678343|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.406||0.05|TWO_SIDED|95.0|0.0|1.59|||ANCOVA|||||1.59|-0.00|0.050
71846354|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-19.2|STANDARD_ERROR_OF_MEAN|9.24|||TWO_SIDED|95.0|-37.3|-1.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||-1.1|-37.3|
71846355|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-49.9|STANDARD_ERROR_OF_MEAN|9.68|||TWO_SIDED|95.0|-68.9|-30.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||-30.9|-68.9|
71846356|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-28.1|STANDARD_ERROR_OF_MEAN|9.01|||TWO_SIDED|95.0|-45.8|-10.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||-10.4|-45.8|
71846357|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-43.1|STANDARD_ERROR_OF_MEAN|9.86|||TWO_SIDED|95.0|-62.4|-23.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||-23.7|-62.4|
71846358|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-31.1|STANDARD_ERROR_OF_MEAN|9.34|||TWO_SIDED|95.0|-49.5|-12.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||-12.8|-49.5|
71846359|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-45.8|STANDARD_ERROR_OF_MEAN|9.7|||TWO_SIDED|95.0|-64.9|-26.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||-26.8|-64.9|
71846360|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-23.7|STANDARD_ERROR_OF_MEAN|9.31|||TWO_SIDED|95.0|-42.0|-5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||-5.4|-42.0|
71898003|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|6.949||||0.012|TWO_SIDED|95.0|1.881|44.892||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 7||44.892|1.881|0.012
71898004|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|5.344||||0.032|TWO_SIDED|95.0|1.381|35.134||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||35.134|1.381|0.032
71898005|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|7.514||||0.008|TWO_SIDED|95.0|2.055|48.354||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 8||48.354|2.055|0.008
71898006|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|3.238||||0.026|TWO_SIDED|95.0|1.222|10.148||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.148|1.222|0.026
71898007|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|3.438||||0.019|TWO_SIDED|95.0|1.311|10.714||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 9||10.714|1.311|0.019
71898008|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|2.626||||0.037|TWO_SIDED|95.0|1.101|6.951||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||6.951|1.101|0.037
71898009|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|2.758||||0.027|TWO_SIDED|95.0|1.167|7.263||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 10||7.263|1.167|0.027
71898010|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|1.69||||0.21|TWO_SIDED|95.0|0.753|3.968||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||3.968|0.753|0.210
71678344|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.469||0.33|TWO_SIDED|95.0|-1.38|0.46|||ANCOVA|||||0.46|-1.38|0.33
71898011|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|2.01||||0.087|TWO_SIDED|95.0|0.923|4.634||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 11||4.634|0.923|0.087
71898012|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|2.1||||0.148|TWO_SIDED|95.0|0.795|6.157||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||6.157|0.795|0.148
71898013|NCT04003155|143319133|SUPERIORITY||Odds Ratio (OR)|3.262||||0.015|TWO_SIDED|95.0|1.329|9.194||Based on logistic regression with treatment group and smoking status (current vs former/never) as factors and mean frequency of vasomotor symptoms at baseline as a covariate.|Regression, Logistic|||Week 12||9.194|1.329|0.015
71898014|NCT02778867|143319183|OTHER|||||||0.58||||||α \< 0.05|Fisher Exact|Two-sided||||||0.58
71898015|NCT02778867|143319184|OTHER|||||||0.06||||||α \< 0.05|Fisher Exact|Two sided||||||0.06
71898016|NCT02778867|143319187|OTHER|||||||0.9||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.90
71898017|NCT02778867|143319188|OTHER|||||||0.22||||||α \< 0.05|t-test, 2 sided|Two sample t-test||||||0.22
71678345|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.407||0.44|TWO_SIDED|95.0|-0.48|1.12|||ANCOVA|||||1.12|-0.48|0.44
71678346|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.408||0.28|TWO_SIDED|95.0|-1.24|0.36|||ANCOVA|||||0.36|-1.24|0.28
71898018|NCT02778867|143319189|OTHER|||||||0.71||||||α \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.71
71898019|NCT00719576|143319196|SUPERIORITY|The Wilks lambda test statistic and associated single P value from the MANOVA model were used to test the statistical significance of the difference in the co-primary endpoint between MACI and microfracture.||||||0.001|||||||MANOVA|||The changes from Baseline to Week 104 in KOOS Pain and Function (SRA) scores (co-primary efficacy parameter) were analyzed with a multivariate analysis of variance (MANOVA) model, with the last observation carried forward (LOCF) method for handling missing data. Terms included in the model are treatment and center as class variables and baseline KOOS pain and Function (SRA) as continuous covariates.||||0.001
71898020|NCT00719576|143319197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Differences between groups were tested using analysis of variance|ANOVA|ANOVA with terms for treatment and center||||||.717
71898021|NCT00719576|143319198|SUPERIORITY|||||||0.92|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Row Mean Score Chi-Square||Differences between groups were tested by the Cochran-Mantel-Haenszel row mean score chi-squared test for defect fill.||||.920
71678347|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.41||0.42|TWO_SIDED|95.0|-1.14|0.47|||ANCOVA|||||0.47|-1.14|0.42
71846361|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-47.3|STANDARD_ERROR_OF_MEAN|9.69|||TWO_SIDED|95.0|-66.4|-28.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||-28.3|-66.4|
71846362|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-28.0|STANDARD_ERROR_OF_MEAN|9.43|||TWO_SIDED|95.0|-46.5|-9.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||-9.5|-46.5|
71846363|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-40.9|STANDARD_ERROR_OF_MEAN|9.94|||TWO_SIDED|95.0|-60.4|-21.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||-21.4|-60.4|
71846364|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|9.48|||TWO_SIDED|95.0|-49.6|-12.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||-12.4|-49.6|
71846365|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-61.9|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||-23.3|-61.9|
71846366|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-29.1|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-47.9|-10.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||-10.3|-47.9|
71846367|NCT02434328|143207431|OTHER|Treatment difference|Least Squares Mean Difference|-42.6|STANDARD_ERROR_OF_MEAN|9.87|||TWO_SIDED|95.0|-62.0|-23.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||-23.3|-62.0|
71846368|NCT02434328|143207432|OTHER|Treatment difference|Least Squares Mean Difference|-36.1|STANDARD_ERROR_OF_MEAN|9.13|||TWO_SIDED|95.0|-54.0|-18.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-18.1|-54.0|
71846369|NCT02434328|143207433|OTHER|Treatment difference|Least Squares Mean Difference|-36.3|STANDARD_ERROR_OF_MEAN|9.56|||TWO_SIDED|95.0|-55.1|-17.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|||-17.6|-55.1|
71846370|NCT02434328|143207434|OTHER|Treatment difference|Least Squares Mean Difference|-30.8|STANDARD_ERROR_OF_MEAN|8.53|||TWO_SIDED|95.0|-47.6|-14.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48||-14.1|-47.6|
71846371|NCT02434328|143207434|OTHER|Treatment difference|Least Squares Mean Difference|-33.5|STANDARD_ERROR_OF_MEAN|8.84|||TWO_SIDED|95.0|-50.8|-16.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96||-16.1|-50.8|
71846372|NCT02434328|143207435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|0.0|0.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||0.7|0.0|
71846373|NCT02434328|143207435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.1|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||0.6|-0.1|
71846374|NCT02434328|143207435|OTHER|Treatment difference|Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|0.0|0.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline lesion size categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||0.6|0.0|
71846375|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.8|||TWO_SIDED|95.0|-11.6|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4||7.3|-11.6|
71846376|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-13.6|6.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8||6.0|-13.6|
71846377|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|95.0|-14.3|5.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12||5.3|-14.3|
71678348|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.406||0.16|TWO_SIDED|95.0|-1.37|0.23|||ANCOVA|||||0.23|-1.37|0.16
71678349|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.467||0.7|TWO_SIDED|95.0|-1.1|0.73|||ANCOVA|||||0.73|-1.10|0.70
71898022|NCT00719576|143319199|SUPERIORITY|||||||0.016||||||KOOS Response Rate: a participant is regarded as a responder for KOOS if a 10-point improvement in both KOOS Pain and Function (SRA) scores was achieved with respect to Baseline. Otherwise, the patient is regarded as a nonresponder.|Cochran-Mantel-Haenszel|p-value was calculated for response categories 'Responded' and 'Not responded' using a Cochran-Mantel-Haenszel χ2 Test stratified by Center||Differences between groups were tested by the Cochran-Mantel-Haenszel chi-squared test stratified by center for responders.||||0.016
71898023|NCT00719576|143319201|SUPERIORITY||||||<|0.001||||||KOOS activities of daily living p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
71898024|NCT00719576|143319201|SUPERIORITY|||||||0.029||||||KOOS knee-related quality of life p-value 0.029|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||0.029
71898025|NCT00719576|143319201|SUPERIORITY||||||<|0.001||||||KOOS other symptoms p-value \<0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.||||<0.001
71898026|NCT00305006|143319210|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.0|<|0.01|TWO_SIDED|95.0||||ANOVA|ANOVA|||ANOVA||||<0.01
71898027|NCT00631488|143319212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.9||||0.002|TWO_SIDED|95.0|5.2|22.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval (CI) for the between group difference.||22.7|5.2|0.002
71898028|NCT00631488|143319212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||<|0.001|TWO_SIDED|95.0|-26.5|-9.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-9.2|-26.5|<0.001
71898029|NCT00631488|143319213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||18.2|0.0|0.050
71898030|NCT00631488|143319213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||<|0.001|TWO_SIDED|95.0|-28.0|-10.1|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-10.1|-28.0|<0.001
71898031|NCT00631488|143319214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||45.8|-0.6|0.056
71898032|NCT00631488|143319214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.6|||<|0.001|TWO_SIDED|95.0|-67.3|-21.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.||-21.8|-67.3|<0.001
71898033|NCT00631488|143319215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.001|TWO_SIDED|95.0|1.7|6.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||6.7|1.7|0.001
71678350|NCT01340027|142875308|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.464||0.4|TWO_SIDED|95.0|-1.3|0.52|||ANCOVA|||||0.52|-1.30|0.40
71898034|NCT00631488|143319215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||<|0.001|TWO_SIDED|95.0|10.7|15.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||15.7|10.7|<0.001
71898035|NCT00631488|143319216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.5|-3.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference||-3.8|-9.5|<0.001
71898036|NCT00631488|143319216|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.3|||<|0.001|TWO_SIDED|95.0|-14.1|-8.5|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.||-8.5|-14.1|<0.001
71898037|NCT00103194|143319217|SUPERIORITY_OR_OTHER||PSA response rate|0.0|||||TWO_SIDED|90.0|0.0|8.2||||||||8.2|0|
71898038|NCT00103194|143319218|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.||||||0.006
71898039|NCT03864237|143319233|SUPERIORITY||beta coefficient for condition|0.53|STANDARD_ERROR_OF_MEAN|0.93||0.568|TWO_SIDED|95.0|-1.31|2.37|||Regression, Linear|Regression controls for baseline value of outcome and sex to determine pre-post change in the outcome as a function of condition.||||2.37|-1.31|0.568
71898040|NCT03864237|143319234|SUPERIORITY||beta coefficient for condition|1.22|STANDARD_ERROR_OF_MEAN|0.69||0.077|TWO_SIDED|95.0|-0.13|2.59|||Regression, Linear|||||2.59|-0.13|0.077
71898041|NCT03864237|143319235|SUPERIORITY||beta coefficient for condition|-1.21|STANDARD_ERROR_OF_MEAN|1.17||0.3|TWO_SIDED|95.0|-3.52|1.11|||Regression, Linear|||||1.11|-3.52|0.30
71898042|NCT03864237|143319236|SUPERIORITY||beta coefficient for condition|0.84|STANDARD_ERROR_OF_MEAN|1.09||0.44|TWO_SIDED|95.0|-1.31|3.0|||Regression, Linear|||||3.0|-1.31|0.44
71898043|NCT03864237|143319237|SUPERIORITY||Beta coefficient for condition|-0.25|STANDARD_ERROR_OF_MEAN|1.29||0.845|TWO_SIDED|95.0|-2.81|2.3|||Regression, Linear|||||2.30|-2.81|0.845
71898044|NCT03864237|143319238|SUPERIORITY||Beta coefficient for condition|0.3|STANDARD_ERROR_OF_MEAN|1.01||0.77|TWO_SIDED|95.0|-1.72|2.31|||Regression, Linear|||||2.31|-1.72|0.77
71898045|NCT03864237|143319239|SUPERIORITY||Beta coefficient for condition|1.77|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-1.0|4.54|||Regression, Linear|||||4.54|-1.0|0.21
71898046|NCT02546856|143319240|NON_INFERIORITY|For the hypothesis that the relative dose of BBs would reach 52% by the end of the study and using an equivalence margin of 7%, we would need 157 patients per group for an alpha level of significance of 0.05 and a statistical power of 80% (beta of 0.80).|Mean Difference (Final Values)|14.8|||<|0.001|TWO_SIDED|95.0|7.5|22.1|||t-test, 2 sided|||||22.1|7.5|<0.001
71898047|NCT02546856|143319241|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|1.4||||0.52|TWO_SIDED|95.0|-3.33|6.32|||Chi-squared|||||6.32|-3.33|0.52
71898048|NCT02546856|143319242|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.1||||0.31|TWO_SIDED|95.0|-1.9|6.1|||Chi-squared|||||6.1|-1.9|0.31
71898049|NCT02546856|143319243|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.63||||0.85|TWO_SIDED|95.0|-7.1|5.85|||Chi-squared|||||5.85|-7.1|0.85
71898050|NCT02546856|143319244|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|2.12||||0.44|TWO_SIDED|95.0|-3.3|7.54|||Chi-squared|||||7.54|-3.3|0.44
71898051|NCT02546856|143319246|NON_INFERIORITY|equivalence margin of 5%|Difference in percentages|0.7||||0.56|TWO_SIDED|95.0|-1.6|3.04|||Chi-squared|||||3.04|-1.6|0.56
71898052|NCT02546856|143319250|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.07||||0.96|TWO_SIDED|95.0|-2.69|2.83|||t-test, 2 sided|||||2.83|-2.69|0.96
71898053|NCT02546856|143319251|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|16.47||||0.97|TWO_SIDED|95.0|-781.0|748.0|||t-test, 2 sided|||||748|-781|0.97
71898054|NCT02546856|143319252|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|7.28||||0.44|TWO_SIDED|95.0|-11.27|25.83|||t-test, 2 sided|||||25.83|-11.27|0.44
71898055|NCT02546856|143319254|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|-0.91||||0.75|TWO_SIDED|95.0|-6.63|4.81|||t-test, 2 sided|||||4.81|-6.63|0.75
71898056|NCT02546856|143319255|NON_INFERIORITY|Equivalence margin of 5%|Mean Difference (Final Values)|0.04||||0.2|TWO_SIDED|95.0|-0.2|0.28|||t-test, 2 sided|||||0.28|-0.2|0.20
71898057|NCT02546856|143319256|EQUIVALENCE|equivalence margin of 5%|Difference in percentages|-5.5||||0.01|TWO_SIDED|95.0|-9.7|-1.4|||Chi-squared|||||-1.4|-9.7|0.01
71898058|NCT02546856|143319257|NON_INFERIORITY|Equivalence margin of 5%|Difference in percentages|-0.68||||0.71|TWO_SIDED|95.0|-4.2|2.87|||Chi-squared|Equivalence margin of 7%||||2.87|-4.2|0.71
71898059|NCT02546856|143319258|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|16.5|||<|0.001|TWO_SIDED|95.0|8.7|24.3|||t-test, 2 sided|||||24.3|8.7|<0.001
71898060|NCT02546856|143319259|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.9||||0.93|TWO_SIDED|95.0|-15.1|17.1|||t-test, 2 sided|||||17.1|-15.1|0.93
71678351|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.079||0.062|TWO_SIDED|95.0|-0.3|0.01|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.01|-0.30|0.062
71678352|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.065||0.15|TWO_SIDED|95.0|-0.22|0.03|||ANCOVA|||||0.03|-0.22|0.15
71846378|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-13.7|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16||6.4|-13.7|
71846379|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|5.11|||TWO_SIDED|95.0|-5.5|14.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20||14.6|-5.5|
71846380|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|5.35|||TWO_SIDED|95.0|-16.3|4.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24||4.7|-16.3|
71846381|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|95.0|-13.1|7.0||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28||7.0|-13.1|
71846382|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|5.37|||TWO_SIDED|95.0|-12.6|8.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32||8.5|-12.6|
71846383|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-15.2|5.1||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36||5.1|-15.2|
71846384|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-17.0|3.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40||3.8|-17.0|
71846385|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.4|7.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44||7.9|-13.4|
71846386|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|3.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48||3.7|-17.6|
71846387|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|5.19|||TWO_SIDED|95.0|-12.9|7.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52||7.5|-12.9|
71898061|NCT02546856|143319260|NON_INFERIORITY|Equivalence margin of 7%|Mean Difference (Final Values)|0.5||||0.86|TWO_SIDED|95.0|-7.1|8.2|||t-test, 2 sided|||||8.2|-7.1|0.86
71898062|NCT01097616|143319264|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.6|||<|1e-05|TWO_SIDED|95.0|12.0|27.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.1|12.0|<0.00001
71898063|NCT01097616|143319265|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|19.7|||<|1e-05|TWO_SIDED|95.0|11.9|27.6||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||27.6|11.9|<0.00001
71898064|NCT01097616|143319266|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.3|||<|1e-05|TWO_SIDED|95.0|-33.5|-19.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-19.2|-33.5|<0.00001
71898065|NCT01097616|143319267|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-22.9|||<|1e-05|TWO_SIDED|95.0|-30.3|-15.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-15.4|-30.3|<0.00001
71898066|NCT01097616|143319268|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.4||||0.00298|TWO_SIDED|95.0|-12.3|-2.5||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-2.5|-12.3|0.00298
71898067|NCT01097616|143319269|SUPERIORITY_OR_OTHER||[Difference in Least Squares Means|-8.4||||0.00019|TWO_SIDED|95.0|-12.8|-4.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.0|-12.8|0.00019
71898068|NCT01097616|143319270|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-11.2||||2e-05|TWO_SIDED|95.0|-16.3|-6.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-6.1|-16.3|0.00002
71898069|NCT01097616|143319271|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.4||||0.00037|TWO_SIDED|95.0|-14.6|-4.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.||-4.3|-14.6|0.00037
71898070|NCT01097616|143319272|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|13.6||||7e-05|TWO_SIDED|95.0|6.9|20.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||20.3|6.9|0.00007
71678353|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.065||0.007|TWO_SIDED|95.0|-0.3|-0.05|||ANCOVA|||||-0.05|-0.30|0.007
71678354|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.066||0.017|TWO_SIDED|95.0|-0.29|-0.03|||ANCOVA|||||-0.03|-0.29|0.017
71678355|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||ANCOVA|||||-0.10|-0.35|<0.001
71678356|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.078|<|0.001|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|||||-0.11|-0.41|<0.001
71846388|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|5.31|||TWO_SIDED|95.0|-15.4|5.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56||5.4|-15.4|
71846389|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|5.15|||TWO_SIDED|95.0|-14.3|5.9||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60||5.9|-14.3|
71846390|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.2|6.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64||6.4|-14.2|
71846391|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|5.17|||TWO_SIDED|95.0|-10.7|9.6||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68||9.6|-10.7|
71846392|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|5.24|||TWO_SIDED|95.0|-14.8|5.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72||5.7|-14.8|
71846393|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|5.23|||TWO_SIDED|95.0|-13.1|7.4||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76||7.4|-13.1|
71846394|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|5.33|||TWO_SIDED|95.0|-14.1|6.8||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80||6.8|-14.1|
71846395|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-13.5|7.3||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84||7.3|-13.5|
71846396|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|-14.6|6.5||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88||6.5|-14.6|
71846397|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|95.0|-12.6|8.0|||ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92||8.0|-12.6|
71846398|NCT02434328|143207436|OTHER|Treatment difference|Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|5.42|||TWO_SIDED|95.0|-13.6|7.7||Hypothesis testing not pre-specified.|ANOVA|Analyzed using ANOVA model with baseline CSFT-neurosensory retina categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96||7.7|-13.6|
71846399|NCT02434328|143207437|OTHER||Difference in proportions|-6.6|||||TWO_SIDED|95.0|-13.2|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||-0.3|-13.2|
71846400|NCT02434328|143207437|OTHER||Difference in proportions|-8.5|||||TWO_SIDED|95.0|-13.8|-3.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-3.0|-13.8|
71846401|NCT02434328|143207437|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.2|-1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-1.7|-12.2|
71846402|NCT02434328|143207437|OTHER||Difference in proportions|-14.2|||||TWO_SIDED|95.0|-20.8|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-8.3|-20.8|
71846403|NCT02434328|143207437|OTHER||Difference in proportions|3.1|||||TWO_SIDED|95.0|-2.9|9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||9.6|-2.9|
71846404|NCT02434328|143207437|OTHER||Difference in proportions|-19.2|||||TWO_SIDED|95.0|-25.5|-13.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.0|-25.5|
71678357|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.077||0.07|TWO_SIDED|95.0|-0.29|0.01|||ANCOVA|||||0.01|-0.29|0.070
71898071|NCT01097616|143319272|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|21.4|||<|1e-05|TWO_SIDED|95.0|15.5|27.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||27.4|15.5|<0.00001
71898072|NCT01097616|143319273|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|16.3||||0.00016|TWO_SIDED|95.0|7.9|24.8|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||24.8|7.9|0.00016
71898073|NCT01097616|143319274|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|10.7||||0.01711|TWO_SIDED|95.0|1.9|19.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||19.5|1.9|0.01711
71898074|NCT01097616|143319275|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-32.5|||<|1e-05|TWO_SIDED|95.0|-39.3|-25.7|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-25.7|-39.3|<0.00001
71898075|NCT01097616|143319275|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-38.4|||<|1e-05|TWO_SIDED|95.0|-44.5|-32.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-32.3|-44.5|<0.00001
71898076|NCT01097616|143319276|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-26.4|||<|1e-05|TWO_SIDED|95.0|-34.3|-18.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-18.4|-34.3|<0.00001
71898077|NCT01097616|143319277|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.6||||9e-05|TWO_SIDED|95.0|-24.8|-8.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-8.3|-24.8|0.00009
71898078|NCT01097616|143319278|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.6||||0.01564|TWO_SIDED|95.0|-10.2|-1.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-1.1|-10.2|0.01564
71898079|NCT01097616|143319278|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.7||||0.00609|TWO_SIDED|95.0|-9.7|-1.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-1.6|-9.7|0.00609
71898080|NCT01097616|143319279|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.4||||0.05191|TWO_SIDED|95.0|-10.9|0.0|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||0.0|-10.9|0.05191
71898081|NCT01097616|143319280|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-5.2||||0.03771|TWO_SIDED|95.0|-10.2|-0.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-0.3|-10.2|0.03771
71678358|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.09||0.15|TWO_SIDED|95.0|-0.05|0.31|||ANCOVA|||||0.31|-0.05|0.15
71678359|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.089||0.57|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|||||0.23|-0.12|0.57
71678360|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.089||0.89|TWO_SIDED|95.0|-0.16|0.19|||ANCOVA|||||0.19|-0.16|0.89
71678361|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.077||0.086|TWO_SIDED|95.0|-0.02|0.29|||ANCOVA|||||0.29|-0.02|0.086
71678362|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.88|TWO_SIDED|95.0|-0.19|0.16|||ANCOVA|||||0.16|-0.19|0.88
71678363|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.078||0.61|TWO_SIDED|95.0|-0.11|0.19|||ANCOVA|||||0.19|-0.11|0.61
71678364|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.078||0.58|TWO_SIDED|95.0|-0.2|0.11|||ANCOVA|||||0.11|-0.20|0.58
71678365|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.76|TWO_SIDED|95.0|-0.18|0.13|||ANCOVA|||||0.13|-0.18|0.76
71678366|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_DEVIATION|0.077||0.23|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||||0.06|-0.25|0.23
71678367|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.089||0.15|TWO_SIDED|95.0|-0.3|0.05|||ANCOVA|||||0.05|-0.30|0.15
71678368|NCT01340027|142875309|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.088||0.94|TWO_SIDED|95.0|-0.18|0.17|||ANCOVA|||||0.17|-0.18|0.94
71678369|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.33||0.29|TWO_SIDED|95.0|-0.99|0.3|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.30|-0.99|0.29
71678370|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.239||0.15|TWO_SIDED|95.0|-0.12|0.82|||ANCOVA|||||0.82|-0.12|0.15
71678371|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.248||0.99|TWO_SIDED|95.0|-0.48|0.49|||ANCOVA|||||0.49|-0.48|0.99
71678372|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.239||0.76|TWO_SIDED|95.0|-0.54|0.4|||ANCOVA|||||0.40|-0.54|0.76
71678373|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.238||0.3|TWO_SIDED|95.0|-0.71|0.22|||ANCOVA|||||0.22|-0.71|0.30
71678374|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.262||0.43|TWO_SIDED|95.0|-0.72|0.31|||ANCOVA|||||0.31|-0.72|0.43
71678375|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.296||0.4|TWO_SIDED|95.0|-0.83|0.33|||ANCOVA|||||0.33|-0.83|0.40
71678376|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.343||0.24|TWO_SIDED|95.0|-1.08|0.27|||ANCOVA|||||0.27|-1.08|0.24
71678377|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.34||0.36|TWO_SIDED|95.0|-0.98|0.36|||ANCOVA|||||0.36|-0.98|0.36
71678378|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.348||0.02|TWO_SIDED|95.0|-1.49|-0.13|||ANCOVA|||||-0.13|-1.49|0.020
71678379|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.293||0.011|TWO_SIDED|95.0|-1.33|-0.18|||ANCOVA|||||-0.18|-1.33|0.011
71678380|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.377||0.004|TWO_SIDED|95.0|-1.84|-0.36|||ANCOVA|||||-0.36|-1.84|0.004
71678381|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.301||0.18|TWO_SIDED|95.0|-1.0|0.19|||ANCOVA|||||0.19|-1.00|0.18
71678382|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.308||0.015|TWO_SIDED|95.0|-1.35|-0.14|||ANCOVA|||||-0.14|-1.35|0.015
71678383|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.301||0.006|TWO_SIDED|95.0|-1.41|-0.23|||ANCOVA|||||-0.23|-1.41|0.006
71678384|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-1.59|-0.41|||ANCOVA|||||-0.41|-1.59|<0.001
71678385|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.32||0.003|TWO_SIDED|95.0|-1.59|-0.33|||ANCOVA|||||-0.33|-1.59|0.003
71846405|NCT02434328|143207437|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.6|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||-0.4|-11.6|
71846406|NCT02434328|143207437|OTHER||Difference in proportions|-9.8|||||TWO_SIDED|95.0|-16.5|-3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-3.5|-16.5|
71846407|NCT02434328|143207437|OTHER||Difference in proportions|-8.0|||||TWO_SIDED|95.0|-13.6|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-2.5|-13.6|
71846408|NCT02434328|143207437|OTHER||Difference in proportions|-15.4|||||TWO_SIDED|95.0|-21.5|-9.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.4|-21.5|
71846409|NCT02434328|143207437|OTHER||Difference in proportions|2.5|||||TWO_SIDED|95.0|-3.2|8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.4|-3.2|
71846410|NCT02434328|143207437|OTHER||Difference in proportions|-15.9|||||TWO_SIDED|95.0|-22.4|-10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-10.4|-22.4|
71846411|NCT02434328|143207437|OTHER||Difference in proportions|-2.7|||||TWO_SIDED|95.0|-8.5|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.1|-8.5|
71846412|NCT02434328|143207437|OTHER||Difference in proportions|-9.0|||||TWO_SIDED|95.0|-15.7|-2.9|||Regression, Logistic|Hypothesis testing not pre-specified.|Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.9|-15.7|
71846413|NCT02434328|143207437|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-9.8|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||2.2|-9.8|
71846414|NCT02434328|143207437|OTHER||Difference in proportions|-15.1|||||TWO_SIDED|95.0|-21.3|-8.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.4|-21.3|
71846415|NCT02434328|143207437|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-6.1|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.2|-6.1|
71846416|NCT02434328|143207437|OTHER||Difference in proportions|-16.6|||||TWO_SIDED|95.0|-22.6|-10.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-10.5|-22.6|
71846417|NCT02434328|143207437|OTHER||Difference in proportions|-1.1|||||TWO_SIDED|95.0|-7.0|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.1|-7.0|
71846418|NCT02434328|143207437|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-17.4|-5.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-5.0|-17.4|
71678386|NCT01340027|142875310|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.348||0.004|TWO_SIDED|95.0|-1.68|-0.31|||ANCOVA|||||-0.31|-1.68|0.004
71846419|NCT02434328|143207437|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-11.3|0.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||0.7|-11.3|
71846420|NCT02434328|143207437|OTHER||Difference in proportions|-12.0|||||TWO_SIDED|95.0|-18.9|-5.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-5.9|-18.9|
71688677|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.15|0.25|||t-test, 2 sided|||FEV1 Day 1 (1 hrs post-dose)||0.25|0.15|<0.0001
71846421|NCT02434328|143207437|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-11.4|0.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.0|-11.4|
71846422|NCT02434328|143207437|OTHER||Difference in proportions|-14.5|||||TWO_SIDED|95.0|-20.3|-8.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-8.3|-20.3|
71846423|NCT02434328|143207438|OTHER||Difference in proportions|1.5|||||TWO_SIDED|95.0|-2.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||5.4|-2.5|
71846424|NCT02434328|143207438|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.1|1.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||1.7|-6.1|
71846425|NCT02434328|143207438|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-5.3|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||2.2|-5.3|
71846426|NCT02434328|143207438|OTHER||Difference in proportions|0.1|||||TWO_SIDED|95.0|-4.5|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||4.4|-4.5|
71846427|NCT02434328|143207438|OTHER||Difference in proportions|8.2|||||TWO_SIDED|95.0|3.9|12.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||12.8|3.9|
71846428|NCT02434328|143207438|OTHER||Difference in proportions|-3.2|||||TWO_SIDED|95.0|-7.9|1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||1.2|-7.9|
71846429|NCT02434328|143207438|OTHER||Difference in proportions|2.8|||||TWO_SIDED|95.0|-1.0|6.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||6.4|-1.0|
71846430|NCT02434328|143207438|OTHER||Difference in proportions|-0.5|||||TWO_SIDED|95.0|-5.5|4.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||4.0|-5.5|
71846431|NCT02434328|143207438|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-5.6|1.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||1.8|-5.6|
71846432|NCT02434328|143207438|OTHER||Difference in proportions|-1.3|||||TWO_SIDED|95.0|-6.0|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||3.1|-6.0|
71846433|NCT02434328|143207438|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.5|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||8.0|-0.5|
71846434|NCT02434328|143207438|OTHER||Difference in proportions|-2.0|||||TWO_SIDED|95.0|-6.2|2.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||2.2|-6.2|
71846435|NCT02434328|143207438|OTHER||Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.5|5.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||5.1|-2.5|
71814776|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.11|||<|0.001|TWO_SIDED|95.0|0.8|1.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.42|0.80|<0.001
71814777|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.43|||<|0.001|TWO_SIDED|95.0|1.09|1.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.78|1.09|<0.001
71814778|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.31||||0.03|TWO_SIDED|95.0|0.03|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|0.03|0.030
71814779|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||<|0.001|TWO_SIDED|95.0|0.78|1.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.46|0.78|<0.001
71814780|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.29|||<|0.001|TWO_SIDED|95.0|0.91|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.91|<0.001
71814781|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.42||||0.007|TWO_SIDED|95.0|0.12|0.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.73|0.12|0.007
71814782|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.87|||<|0.001|TWO_SIDED|95.0|0.49|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.24|0.49|<0.001
71814783|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|1.27|||<|0.001|TWO_SIDED|95.0|0.89|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.89|<0.001
71814784|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.004|TWO_SIDED|95.0|0.15|0.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.76|0.15|0.004
71814785|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.44|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.19|0.44|<0.001
71814786|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.92|||<|0.001|TWO_SIDED|95.0|0.54|1.31||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.31|0.54|<0.001
71814787|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.084|TWO_SIDED|95.0|-0.04|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.59|-0.04|0.084
71814788|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.65||||0.001|TWO_SIDED|95.0|0.27|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|0.27|0.001
71814789|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.93|||<|0.001|TWO_SIDED|95.0|0.54|1.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.32|0.54|<0.001
71814790|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.38||||0.02|TWO_SIDED|95.0|0.06|0.69||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.69|0.06|0.020
71678387|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.177||0.15|TWO_SIDED|95.0|-0.6|0.09|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.09|-0.60|0.15
71678388|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.146||0.78|TWO_SIDED|95.0|-0.33|0.25|||ANCOVA|||||0.25|-0.33|0.78
71678389|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.146||0.58|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.58
71678390|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.147||0.6|TWO_SIDED|95.0|-0.37|0.21|||ANCOVA|||||0.21|-0.37|0.60
71678391|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.145||0.017|TWO_SIDED|95.0|-0.63|-0.06|||ANCOVA|||||-0.06|-0.63|0.017
71678392|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.176||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.10|-0.60|0.16
71678393|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.175||0.13|TWO_SIDED|95.0|-0.61|0.08|||ANCOVA|||||0.08|-0.61|0.13
71814791|NCT01216163|143131365|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.005|TWO_SIDED|95.0|0.17|0.94||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.94|0.17|0.005
71898082|NCT01097616|143319283|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-9.6||||0.00041|TWO_SIDED|95.0|-14.9|-4.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.3|-14.9|0.00041
71678394|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.201||0.81|TWO_SIDED|95.0|-0.35|0.44|||ANCOVA|||||0.44|-0.35|0.81
71678395|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.199||0.67|TWO_SIDED|95.0|-0.48|0.31|||ANCOVA|||||0.31|-0.48|0.67
71678396|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.77|TWO_SIDED|95.0|-0.33|0.45|||ANCOVA|||||0.45|-0.33|0.77
71678397|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.81||0.81|TWO_SIDED|95.0|-0.3|0.38|||ANCOVA|||||0.38|-0.30|0.81
71678398|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.201||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
71678399|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.174||0.99|TWO_SIDED|95.0|-0.34|0.34|||ANCOVA|||||0.34|-0.34|0.99
71678400|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.82|TWO_SIDED|95.0|-0.38|0.3|||ANCOVA|||||0.30|-0.38|0.82
71678401|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.175||0.84|TWO_SIDED|95.0|-0.38|0.31|||ANCOVA|||||0.31|-0.38|0.84
71678402|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.173||0.08|TWO_SIDED|95.0|-0.64|0.04|||ANCOVA|||||0.04|-0.64|0.080
71678403|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED|95.0|-0.6|0.18|||ANCOVA|||||0.18|-0.60|0.30
71678404|NCT01340027|142875311|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.199||0.26|TWO_SIDED|95.0|-0.62|0.17|||ANCOVA|||||0.17|-0.62|0.26
71678405|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.38|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.2|-0.5|0.38
71678406|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.85|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.85
71678407|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.024|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.024
71678408|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.005|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.005
71678409|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.003|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.003
71678410|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.004
71678411|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.15|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.15
71898083|NCT01097616|143319283|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||2e-05|TWO_SIDED|95.0|-15.0|-5.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.||-5.5|-15.0|0.00002
71678412|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.99|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||||0.4|-0.4|0.99
71846436|NCT02434328|143207438|OTHER||Difference in proportions|-1.2|||||TWO_SIDED|95.0|-5.9|3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||3.1|-5.9|
71846437|NCT02434328|143207438|OTHER||Difference in proportions|-0.6|||||TWO_SIDED|95.0|-4.4|3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||3.4|-4.4|
71846438|NCT02434328|143207438|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-6.2|2.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||2.1|-6.2|
71846439|NCT02434328|143207438|OTHER||Difference in proportions|2.6|||||TWO_SIDED|95.0|-1.2|6.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||6.5|-1.2|
71846440|NCT02434328|143207438|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.2|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||4.3|-4.2|
71846441|NCT02434328|143207438|OTHER||Difference in proportions|0.4|||||TWO_SIDED|95.0|-3.5|4.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||4.2|-3.5|
71846442|NCT02434328|143207438|OTHER||Difference in proportions|-0.3|||||TWO_SIDED|95.0|-4.8|4.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||4.3|-4.8|
71846443|NCT02434328|143207438|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-3.3|5.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||5.2|-3.3|
71846444|NCT02434328|143207438|OTHER||Difference in proportions|-0.1|||||TWO_SIDED|95.0|-4.5|3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||3.9|-4.5|
71846445|NCT02434328|143207438|OTHER||Difference in proportions|3.8|||||TWO_SIDED|95.0|-0.1|8.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||8.0|-0.1|
71846446|NCT02434328|143207438|OTHER||Difference in proportions|0.2|||||TWO_SIDED|95.0|-4.3|4.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||4.6|-4.3|
71846447|NCT02434328|143207439|OTHER||Difference in proportions|-3.5|||||TWO_SIDED|95.0|-8.9|1.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||1.5|-8.9|
71678413|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.67|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.67
71898084|NCT01097616|143319284|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3||||0.0004|TWO_SIDED|95.0|-16.0|-4.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-4.6|-16.0|0.00040
71898085|NCT01097616|143319285|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-8.1||||0.00606|TWO_SIDED|95.0|-13.8|-2.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.||-2.3|-13.8|0.00606
71898086|NCT01996319|143319286|SUPERIORITY_OR_OTHER||null hypoth|0.2021|||<|0.0001|TWO_SIDED|95.0|0.1583|0.246|||ANCOVA|||||0.2460|0.1583|<0.0001
71898087|NCT01996319|143319287|SUPERIORITY_OR_OTHER||Null hypoth|36.7126||||0.0399|TWO_SIDED|95.0|1.7241|71.7011|||ANCOVA|||||71.7011|1.7241|0.0399
71898088|NCT00117338|143319294|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.775||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.775
71898089|NCT00117338|143319295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.931||95.0|-0.41|0.45|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.45|-0.41|0.931
71898090|NCT00117338|143319296|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.975||95.0|0.61|1.61|||Regression, Logistic|Model terms: treatment and baseline FEV1 as covariate||||1.61|0.61|0.975
71898091|NCT00117338|143319297|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.612||95.0|-0.05|0.09|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.09|-0.05|0.612
71898092|NCT00117338|143319298|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.774||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.08|-0.06|0.774
71898093|NCT00117338|143319299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.173||95.0|-0.02|0.11|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate||||0.11|-0.02|0.173
71678414|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.44|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||||0.2|-0.5|0.44
71678415|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.88|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||||0.4|-0.3|0.88
71898094|NCT00117338|143319300|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||ANCOVA|ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate||||||0.580
71898095|NCT03626415|143319304|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|94.4|||||TWO_SIDED|90.0|62.96|141.55|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||141.55|62.96|
71898096|NCT03626415|143319304|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adusted Geometric Means|105.53|||||TWO_SIDED|90.0|70.38|158.24|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||158.24|70.38|
71898097|NCT03626415|143319305|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|133.33|||||TWO_SIDED|90.0|86.17|206.28|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||206.28|86.17|
71898098|NCT03626415|143319305|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|153.99|||||TWO_SIDED|90.0|99.52|238.25|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||238.25|99.52|
71898099|NCT03626415|143319306|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|75.94|||||TWO_SIDED|90.0|57.39|100.47|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||100.47|57.39|
71898100|NCT03626415|143319306|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|84.14|||||TWO_SIDED|90.0|63.59|111.33|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||111.33|63.59|
71898101|NCT03626415|143319307|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|95.74|||||TWO_SIDED|90.0|72.71|126.08|||ANOVA|||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||126.08|72.71|
71898102|NCT03626415|143319307|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|114.82|||||TWO_SIDED|90.0|87.19|151.2|||ANOVA|||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)||151.20|87.19|
71898103|NCT01703819|143319312|SUPERIORITY_OR_OTHER|||||||0.7726||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.7726
71898104|NCT01703819|143319313|SUPERIORITY_OR_OTHER|||||||0.5702||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.||||0.5702
71898105|NCT00859898|143319325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1056|<|0.0001|TWO_SIDED|95.0|-0.74|-0.32||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.32|-0.74|<0.0001
71898106|NCT00859898|143319325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1072|<|0.0001|TWO_SIDED|95.0|-0.75|-0.33||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||||-0.33|-0.75|<0.0001
71898107|NCT00859898|143319325|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change in HbA1c from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 0.35%.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054|||TWO_SIDED|95.0|-0.22|0.2|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||0.20|-0.22|
71898108|NCT00859898|143319325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1054||0.9144|TWO_SIDED|95.0|-0.22|0.2||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||0.20|-0.22|0.9144
71898109|NCT00859898|143319326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|3.558|<|0.0001|TWO_SIDED|95.0|-20.9|-7.0||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-7.0|-20.9|<0.0001
71898110|NCT00859898|143319326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-32.6|-18.5||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-18.5|-32.6|<0.0001
71898111|NCT00859898|143319326|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change FPG from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 15 mg/dL.|Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566|||TWO_SIDED|95.0|-18.6|-4.6|||ANCOVA|treatment group as an effect and the baseline value as a covariate||||-4.6|-18.6|
71898112|NCT00859898|143319326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|3.566||0.0012|TWO_SIDED|95.0|-18.6|-4.6||two-sided significance level at α=0.05.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR||-4.6|-18.6|0.0012
71898113|NCT00859898|143319327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|4.598||0.0012|TWO_SIDED|95.0|5.9|23.9||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||23.9|5.9|0.0012
71898114|NCT00859898|143319327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|4.73||0.0165|TWO_SIDED|95.0|2.1|20.6||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).||20.6|2.1|0.0165
71898115|NCT00859898|143319328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1807||0.0133|TWO_SIDED|95.0|-0.81|-0.09||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|: treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.09|-0.81|0.0133
71678416|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.53|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||||0.3|-0.5|0.53
71678417|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||1|TWO_SIDED|95.0|-0.3|0.3|||ANCOVA|||||0.3|-0.3|1.0
71678418|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.084|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0.0|-0.6|0.084
71678419|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||||-0.0|-0.7|0.030
71678420|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.02|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.020
71678421|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.017|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||||-0.1|-0.8|0.017
71678422|NCT01340027|142875312|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.26|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||||0.2|-0.6|0.26
71678423|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.04|TWO_SIDED|95.0|1.04|4.95|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||4.95|1.04|0.040
71678424|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.1||||0.73|TWO_SIDED|95.0|0.63|1.92|||Regression, Logistic|||||1.92|0.63|0.73
71678425|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.82||||0.05|TWO_SIDED|95.0|1.0|3.3|||Regression, Logistic|||||3.30|1.00|0.050
71921815|NCT04269629|143364757|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.5||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.50
71678426|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45||||0.21|TWO_SIDED|95.0|0.81|2.59|||Regression, Logistic|||||2.59|0.81|0.21
71678427|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.02||||0.021|TWO_SIDED|95.0|1.11|3.66|||Regression, Logistic|||||3.66|1.11|0.021
71678428|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.19|TWO_SIDED|95.0|0.79|3.4|||Regression, Logistic|||||3.40|0.79|0.19
71678429|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.57|2.19|||Regression, Logistic|||||2.19|0.57|0.74
71678430|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.57|TWO_SIDED|95.0|0.58|2.71|||Regression, Logistic|||||2.71|0.58|0.57
71678431|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.19|TWO_SIDED|95.0|0.77|3.64|||Regression, Logistic|||||3.64|0.77|0.19
71678432|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.69|TWO_SIDED|95.0|0.41|1.79|||Regression, Logistic|||||1.79|0.41|0.69
71678433|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.9|TWO_SIDED|95.0|0.55|1.99|||Regression, Logistic|||||1.99|0.55|0.90
71678434|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.048|TWO_SIDED|95.0|1.01|5.55|||Regression, Logistic|||||5.55|1.01|0.048
71678435|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.67|TWO_SIDED|95.0|0.6|2.22|||Regression, Logistic|||||2.22|0.60|0.67
71678436|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.07|TWO_SIDED|95.0|0.95|3.78|||Regression, Logistic|||||3.78|0.95|0.070
71678437|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.23|TWO_SIDED|95.0|0.77|2.98|||Regression, Logistic|||||2.98|0.77|0.23
71678438|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.11||||0.034|TWO_SIDED|95.0|1.06|4.19|||Regression, Logistic|||||4.19|1.06|0.034
71678439|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.2|TWO_SIDED|95.0|0.76|3.84|||Regression, Logistic|||||3.84|0.76|0.20
71678440|NCT01340027|142875313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.68|TWO_SIDED|95.0|0.55|2.49|||Regression, Logistic|||||2.49|0.55|0.68
71678441|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.64|2.12|||Regression, Logistic|||||2.12|0.64|0.62
71678442|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.25|TWO_SIDED|95.0|0.82|2.17|||Regression, Logistic|||||2.17|0.82|0.25
71678443|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.11|TWO_SIDED|95.0|0.91|2.41|||Regression, Logistic|||||2.41|0.91|0.11
71678444|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.81||||0.02|TWO_SIDED|95.0|1.1|2.97|||Regression, Logistic|||||2.97|1.10|0.020
71678445|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.012|TWO_SIDED|95.0|1.15|3.05|||Regression, Logistic|||||3.05|1.15|0.012
71678446|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|||||3.10|0.95|0.072
71678447|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.77|2.44|||Regression, Logistic|||||2.44|0.77|0.29
71678448|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.94|TWO_SIDED|95.0|0.49|1.93|||Regression, Logistic|||||1.93|0.49|0.94
71678449|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.8|TWO_SIDED|95.0|0.46|1.81|||Regression, Logistic|||||1.81|0.46|0.80
71678450|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.67|TWO_SIDED|95.0|0.59|2.28|||Regression, Logistic|||||2.28|0.59|0.67
71678451|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.55|1.8|||Regression, Logistic|||||1.80|0.55|1.0
71678452|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.66|TWO_SIDED|95.0|0.59|2.31|||Regression, Logistic|||||2.31|0.59|0.66
71678453|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.35|TWO_SIDED|95.0|0.73|2.4|||Regression, Logistic|||||2.40|0.73|0.35
71898116|NCT00859898|143319328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.1817||0.0036|TWO_SIDED|95.0|-0.89|-0.18||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.18|-0.89|0.0036
71898117|NCT00859898|143319329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3401|<|0.0001|TWO_SIDED|95.0|-2.64|-1.3||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-1.30|-2.64|<0.0001
71898118|NCT00859898|143319329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3362|<|0.0001|TWO_SIDED|95.0|-2.03|-0.71||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate||Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.||-0.71|-2.03|<0.0001
71898119|NCT02145156|143319337|SUPERIORITY_OR_OTHER|||||||0.36|||||||Fisher Exact|||||||.36
71898120|NCT02145156|143319337|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||||||.18
71898121|NCT02145156|143319337|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher Exact|||||||.22
71898122|NCT02145156|143319337|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
71898123|NCT02145156|143319338|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||||||0.35
71898124|NCT02145156|143319338|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71898125|NCT02145156|143319338|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
71898126|NCT02145156|143319338|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
71898127|NCT02145156|143319339|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
71898128|NCT02145156|143319339|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
71898129|NCT02145156|143319339|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
71678454|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.19|TWO_SIDED|95.0|0.82|2.67|||Regression, Logistic|||||2.67|0.82|0.19
71898130|NCT02145156|143319339|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
71898131|NCT02145156|143319340|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
71898132|NCT02145156|143319340|SUPERIORITY_OR_OTHER|||||||0.52|||||||Fisher Exact|||||||.52
71898133|NCT02145156|143319340|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher Exact|||||||.71
71898134|NCT02145156|143319340|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
71898135|NCT02145156|143319341|SUPERIORITY_OR_OTHER|||||||0.16|||||||Fisher Exact|||||||0.16
71898136|NCT02145156|143319341|SUPERIORITY_OR_OTHER|||||||0.15|||||||Fisher Exact|||||||.15
71898137|NCT02145156|143319341|SUPERIORITY_OR_OTHER|||||||0.98|||||||Fisher Exact|||||||.98
71898138|NCT02145156|143319341|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||.34
71898139|NCT02145156|143319342|SUPERIORITY_OR_OTHER|||||||0.37|||||||Fisher Exact|||||||0.37
71898140|NCT02145156|143319342|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||.23
71898141|NCT02145156|143319342|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||.25
71898142|NCT02145156|143319342|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||||||.70
71898143|NCT02145156|143319343|SUPERIORITY_OR_OTHER|||||||0.87|||||||Chi-squared|||||||0.87
71898144|NCT02145156|143319343|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
71898145|NCT02145156|143319343|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||||||0.81
71898146|NCT02145156|143319343|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
71898147|NCT02145156|143319344|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||||||0.70
71898148|NCT02145156|143319344|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
71898149|NCT02145156|143319344|SUPERIORITY_OR_OTHER|||||||0.59|||||||Chi-squared|||||||0.59
71898150|NCT02145156|143319344|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared|||||||0.74
71898151|NCT02145156|143319345|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
71898152|NCT02145156|143319345|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
71898153|NCT02145156|143319345|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
71898154|NCT02145156|143319345|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
71898155|NCT02145156|143319346|SUPERIORITY_OR_OTHER|||||||0.39|||||||Chi-squared|||||||0.39
71898156|NCT02145156|143319346|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
71898157|NCT02145156|143319346|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
71898158|NCT02145156|143319346|SUPERIORITY_OR_OTHER|||||||0.14|||||||Chi-squared|||||||0.14
71898159|NCT02145156|143319347|SUPERIORITY_OR_OTHER|||||||0.09|||||||Chi-squared|||||||0.09
71898160|NCT02145156|143319347|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
71898161|NCT02145156|143319347|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
71898162|NCT02145156|143319347|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71898163|NCT02145156|143319348|SUPERIORITY_OR_OTHER|||||||0.38|||||||Chi-squared|||||||0.38
71898164|NCT02145156|143319348|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||||||0.17
71898165|NCT02145156|143319348|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.60
71898166|NCT02145156|143319348|SUPERIORITY_OR_OTHER|||||||0.35|||||||Chi-squared|||||||0.35
71921816|NCT04269629|143364758|OTHER|||||||0.72||||||The level of significance was set at 0.05.|Fisher Exact|||||||0.72
71898167|NCT05232097|143319399|OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the median of differences of the rumination score before and after therapy equals 0.||||0.005
71898168|NCT05232097|143319400|OTHER|||||||0.11|||||||Chi-squared|||The null hypothesis is that the same number of patients has intragastric pressure peaks indicating rumination before and after therapy.||||0.11
71898169|NCT05232097|143319401|OTHER|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: The differences of means of 15D before and after therapy equals 0.||||0.060
71898170|NCT05232097|143319402|OTHER|||||||0.865|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The median of differences of WHODAS 2.0 before and after therapy equals 0.||||0.865
71898171|NCT05232097|143319403|OTHER|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis : the differences of median BDI before and after behavioral therapy equals 0.||||0.149
71898172|NCT05232097|143319404|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median of BAI before and after behavioral therapy equals 0.||||1.000
71898173|NCT05232097|143319405|OTHER|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: The differences of median weight before and after therapy equals 0.||||0.102
71898174|NCT02853331|143319431|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.00012|TWO_SIDED|95.0|0.56|0.84|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.84|0.56|0.00012
71898175|NCT02853331|143319432|SUPERIORITY||Hazard Ratio (HR)|0.53||||5e-05|TWO_SIDED|95.0|0.38|0.74|||Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||0.74|0.38|0.00005
71898176|NCT02853331|143319433|SUPERIORITY||Difference in percentages|23.6|||<|0.0001|TWO_SIDED|95.0|17.2|29.9|||Miettinen & Nurminen method|H0: difference in %=0 versus H1: difference in % \>0|Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||29.9|17.2|<0.0001
71898177|NCT02853331|143319434|SUPERIORITY||Difference in percentages|11.0|||||TWO_SIDED|95.0|4.8|17.0|||||Difference in percentages based on Miettinen \& Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).|||17.0|4.8|
71678455|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.054|TWO_SIDED|95.0|0.99|3.28|||Regression, Logistic|||||3.28|0.99|0.054
71898178|NCT03290300|143319470|OTHER||||||<|0.0001||||||The pre-specified threshold for statistical significance was p\<0.05.|ANOVA|Repeated measures ANOVA with multiple comparisons to baseline||||||<0.0001
71898179|NCT01520922|143319473|SUPERIORITY_OR_OTHER||Percentage of participants|95.0|||||TWO_SIDED|95.0|84.53|99.44|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m\^2.|||99.44|84.53|
71678456|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87||||0.038|TWO_SIDED|95.0|1.04|3.38|||Regression, Logistic|||||3.38|1.04|0.038
71678457|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.12|TWO_SIDED|95.0|0.87|3.39|||Regression, Logistic|||||3.39|0.87|0.12
71898180|NCT01520922|143319473|SUPERIORITY_OR_OTHER||Percentage of participants|74.0|||||TWO_SIDED|95.0|59.67|84.74|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m\^2.|||84.74|59.67|
71898181|NCT03461289|143319540|SUPERIORITY||Difference of Proportion|0.71|||<|0.0001|TWO_SIDED|95.0|0.48|0.87|||Fisher Exact||||Data for the current study were compared to historical control data (Finkel et al 2014 - PubMed 25080519) where 6 out of 23 (26.1%) babies were alive and did not need mechanical ventilation at 14 months of age.|0.87|0.48|<0.0001
71898182|NCT02222129|143319551|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.||||0.39
71898183|NCT03504774|143319588|OTHER||Mean Difference (Net)|0.6||||0.3|TWO_SIDED||||||Mixed Models Analysis|||analysis of the change from baseline in CD28 expression||||0.30
71898184|NCT03504774|143319589|OTHER||Mean Difference (Net)|0.9||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.82
71898185|NCT03504774|143319589|OTHER||Mean Difference (Net)|1.2||||0.053|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis on the change from baseline to week 58||||0.053
71898186|NCT03504774|143319589|OTHER||Mean Difference (Net)|0.3||||0.062|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.062
71898187|NCT03504774|143319589|OTHER||Mean Difference (Net)|0.2||||0.3|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 52||||0.30
71898188|NCT03504774|143319589|OTHER||Mean Difference (Net)|1.0||||0.54|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from baseline to week 58||||0.54
71898189|NCT03504774|143319589|OTHER||Mean Difference (Net)|1.2||||0.82|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change from week 52 to week 58||||0.82
71898190|NCT03504774|143319590|OTHER||Mean Difference (Net)|4.8||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.25
71898191|NCT03504774|143319590|OTHER||Mean Difference (Net)|10.8||||0.24|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.24
71898192|NCT03504774|143319590|OTHER||Mean Difference (Net)|6.0||||0.61|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.61
71898193|NCT03504774|143319590|OTHER||Mean Difference (Net)|8.5||||0.034|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 52||||0.034
71898194|NCT03504774|143319590|OTHER||Mean Difference (Net)|0.8||||0.45|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from baseline to week 58||||0.45
71678458|NCT01340027|142875314|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.36|TWO_SIDED|95.0|0.7|2.67|||Regression, Logistic|||||2.67|0.70|0.36
71846448|NCT02434328|143207439|OTHER||Difference in proportions|-2.6|||||TWO_SIDED|95.0|-7.6|2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||2.5|-7.6|
71846449|NCT02434328|143207439|OTHER||Difference in proportions|-1.6|||||TWO_SIDED|95.0|-6.9|3.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||3.7|-6.9|
71846450|NCT02434328|143207439|OTHER||Difference in proportions|-7.8|||||TWO_SIDED|95.0|-13.0|-2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-2.7|-13.0|
71846451|NCT02434328|143207439|OTHER||Difference in proportions|1.3|||||TWO_SIDED|95.0|-3.6|6.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||6.2|-3.6|
71846452|NCT02434328|143207439|OTHER||Difference in proportions|-7.9|||||TWO_SIDED|95.0|-12.6|-3.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-3.1|-12.6|
71846453|NCT02434328|143207439|OTHER||Difference in proportions|-2.1|||||TWO_SIDED|95.0|-6.8|2.7||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.7|-6.8|
71846454|NCT02434328|143207439|OTHER||Difference in proportions|-5.3|||||TWO_SIDED|95.0|-10.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-0.3|-10.5|
71846455|NCT02434328|143207439|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.3|-0.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-0.4|-10.3|
71846456|NCT02434328|143207439|OTHER||Difference in proportions|-6.0|||||TWO_SIDED|95.0|-11.2|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-0.5|-11.2|
71846457|NCT02434328|143207439|OTHER||Difference in proportions|0.5|||||TWO_SIDED|95.0|-4.8|5.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||5.6|-4.8|
71846458|NCT02434328|143207439|OTHER||Difference in proportions|-9.1|||||TWO_SIDED|95.0|-13.8|-3.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-3.9|-13.8|
71846459|NCT02434328|143207439|OTHER||Difference in proportions|-1.8|||||TWO_SIDED|95.0|-7.1|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.5|-7.1|
71846460|NCT02434328|143207439|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.1|0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||0.1|-11.1|
71898195|NCT03504774|143319590|OTHER||Mean Difference (Net)|7.7||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in INFG from week 52 to week 58||||0.12
71898196|NCT03504774|143319590|OTHER||Mean Difference (Net)|1.0||||0.83|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.83
71898197|NCT03504774|143319590|OTHER||Mean Difference (Net)|2.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.67
71898198|NCT03504774|143319590|OTHER||Mean Difference (Net)|1.0||||0.8|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.80
71898199|NCT03504774|143319590|OTHER||Mean Difference (Net)|1.7||||0.46|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 52||||0.46
71898200|NCT03504774|143319590|OTHER||Mean Difference (Net)|3.2||||0.48|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from baseline to week 58||||0.48
71898201|NCT03504774|143319590|OTHER||Mean Difference (Net)|3.2||||0.25|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL4 from week 52 to week 58||||0.25
71898202|NCT03504774|143319590|OTHER||Mean Difference (Net)|2.6||||0.14|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.14
71898203|NCT03504774|143319590|OTHER||Mean Difference (Net)|0.6||||0.73|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.73
71898204|NCT03504774|143319590|OTHER||Mean Difference (Net)|2.0||||0.16|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.16
71898205|NCT03504774|143319590|OTHER||Mean Difference (Net)|1.8||||0.47|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 52||||0.47
71898206|NCT03504774|143319590|OTHER||Mean Difference (Net)|1.1||||0.84|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from baseline to week 58||||0.84
71898207|NCT03504774|143319590|OTHER||Mean Difference (Net)|0.7||||0.55|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in IL10 from week 52 to week 58||||0.55
71814792|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.84|||<|0.001|TWO_SIDED|95.0|0.4|1.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.28|0.40|<0.001
71898208|NCT03504774|143319591|OTHER||Mean Difference (Net)|2269.0||||0.23|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.23
71898209|NCT03504774|143319591|OTHER||Mean Difference (Net)|1311.0||||0.12|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.12
71898210|NCT03504774|143319591|OTHER||Mean Difference (Net)|958.0||||0.79|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.79
71898211|NCT03504774|143319591|OTHER||Mean Difference (Net)|347.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 52||||0.29
71898212|NCT03504774|143319591|OTHER||Mean Difference (Net)|4364.0||||0.29|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from baseline to week 58||||0.29
71814793|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.27||||0.148|TWO_SIDED|95.0|-0.1|0.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.63|-0.10|0.148
71898213|NCT03504774|143319591|OTHER||Mean Difference (Net)|4017.0||||0.42|TWO_SIDED||||||Mixed Models Analysis|||within-group analysis of change in GPR15 from week 52 to week 58||||0.42
71898214|NCT00591227|143319609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||95.0|||||t-test, 1 sided|||||||0.58
71898215|NCT05057988|143319646|OTHER|paired T test|Mean Difference (Net)|1.04|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|0.53|1.55|||t-test, 2 sided|||||1.55|0.53|<.001
71898216|NCT05057988|143319647|OTHER|Paired T test|Mean Difference (Net)|0.98|STANDARD_DEVIATION|8.17||0.208|TWO_SIDED|95.0|-1.42|3.37|||t-test, 2 sided|||||3.37|-1.42|.208
71898217|NCT05057988|143319648|OTHER|Paired T test|Mean Difference (Net)|0.86|STANDARD_DEVIATION|1.2|<|0.001|TWO_SIDED|95.0|0.52|1.2|||t-test, 2 sided|||||1.20|0.52|<.001
71898218|NCT05057988|143319649|OTHER|Paired t test|Mean Difference (Net)|0.81|STANDARD_DEVIATION|5.65||0.328|TWO_SIDED|95.0|-0.84|2.47|||t-test, 1 sided|||||2.47|-.84|.328
71898219|NCT05057988|143319650|OTHER|Paired T test|Mean Difference (Final Values)|2.71|STANDARD_DEVIATION|4.95|<|0.001|TWO_SIDED|95.0|1.26|4.16|||t-test, 1 sided|||||4.16|1.26|<.001
71898220|NCT05057988|143319651|OTHER|Paired T test|Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|6.38||0.486|TWO_SIDED|95.0|-1.22|2.53|||t-test, 1 sided|||||2.53|-1.22|.486
71898221|NCT05057988|143319652|OTHER|Paired T test|Mean Difference (Final Values)|-0.24|STANDARD_DEVIATION|7.57||0.832|TWO_SIDED|95.0|-2.46|1.99|||t-test, 2 sided|||||1.99|-2.46|.832
71898222|NCT05057988|143319653|OTHER|Paired T test|Mean Difference (Net)|-0.43|STANDARD_DEVIATION|3.06||0.34|TWO_SIDED|95.0|-1.33|0.47|||t-test, 2 sided|||||0.47|-1.33|.340
71898223|NCT05057988|143319655|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.31||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|paired sample t test||paired sample t test||0.89|-0.34|0.370
71898224|NCT05057988|143319655|OTHER|Paired T test|Mean Difference (Net)|0.28|STANDARD_DEVIATION|2.09||0.37|TWO_SIDED|95.0|-0.34|0.89|||t-test, 2 sided|||||.89|-.34|.370
71898225|NCT00532883|143319760|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||This is a global test comparing all four treatment arms.|Mixed Models Analysis|||F-test from a longitudinal mixed model (controlling for baseline measurement)testing the hypothesis of no difference in mean percent dense cells between the four treatment groups at Visit 6. The study was originally powered to detect a difference of 20%, but it was stopped early.||||0.93
71898226|NCT02202031|143319761|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.6222|TWO_SIDED|95.0|-0.73|1.21|||ANCOVA|change from baseline, adjusted for baseline value||||1.21|-0.73|0.6222
71898227|NCT02202031|143319762|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.7695|TWO_SIDED|95.0|-0.64|0.47|||ANCOVA|change from baseline, adjusted for baseline value||||0.47|-0.64|0.7695
71898228|NCT02202031|143319763|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.6456|TWO_SIDED|95.0|-0.24|0.39|||ANCOVA|change from baseline value, adjusted for baseline value||||0.39|-0.24|0.6456
71898229|NCT02202031|143319764|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.919|TWO_SIDED|95.0|-0.66|0.6|||ANCOVA|change from baseline, adjusted for baseline value||||0.60|-0.66|0.9190
71898230|NCT02202031|143319765|SUPERIORITY||Mean Difference (Final Values)|1.16||||0.5358|TWO_SIDED|95.0|-2.51|4.84|||ANCOVA|change from baseline, adjusted for baseline value.||||4.84|-2.51|0.5358
71898231|NCT02202031|143319766|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.4663|TWO_SIDED|95.0|-2.9|6.34|||ANCOVA|change from baseline, adjusted for baseline value||||6.34|-2.90|0.4663
71846461|NCT02434328|143207439|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-10.9|-0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||-0.5|-10.9|
71846462|NCT02434328|143207439|OTHER||Difference in proportions|-5.1|||||TWO_SIDED|95.0|-10.9|0.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||0.6|-10.9|
71846463|NCT02434328|143207439|OTHER||Difference in proportions|-5.2|||||TWO_SIDED|95.0|-11.0|-0.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||-0.1|-11.0|
71846464|NCT02434328|143207439|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-12.5|-1.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-1.2|-12.5|
71846465|NCT02434328|143207439|OTHER||Difference in proportions|-5.5|||||TWO_SIDED|95.0|-10.7|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||-0.3|-10.7|
71846466|NCT02434328|143207439|OTHER||Difference in proportions|-6.5|||||TWO_SIDED|95.0|-12.4|-0.9||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-0.9|-12.4|
71846467|NCT02434328|143207439|OTHER||Difference in proportions|-1.4|||||TWO_SIDED|95.0|-7.0|4.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||4.4|-7.0|
71846468|NCT02434328|143207439|OTHER||Difference in proportions|-4.8|||||TWO_SIDED|95.0|-10.5|1.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||1.3|-10.5|
71846469|NCT02434328|143207439|OTHER||Difference in proportions|-5.6|||||TWO_SIDED|95.0|-11.4|0.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||0.5|-11.4|
71846470|NCT02434328|143207439|OTHER||Difference in proportions|-5.9|||||TWO_SIDED|95.0|-11.5|-0.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-0.3|-11.5|
71846471|NCT02434328|143207440|OTHER||Difference in proportions|-6.9|||||TWO_SIDED|95.0|-14.2|0.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4||0.2|-14.2|
71846472|NCT02434328|143207440|OTHER||Difference in proportions|-9.2|||||TWO_SIDED|95.0|-15.5|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8||-2.5|-15.5|
71846473|NCT02434328|143207440|OTHER||Difference in proportions|-8.7|||||TWO_SIDED|95.0|-15.0|-2.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12||-2.6|-15.0|
71846474|NCT02434328|143207440|OTHER||Difference in proportions|-15.7|||||TWO_SIDED|95.0|-22.9|-9.0||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16||-9.0|-22.9|
71898232|NCT02202031|143319767|SUPERIORITY||Mean Difference (Final Values)|2.17||||0.3134|TWO_SIDED|95.0|-2.05|6.38|||ANCOVA|change from baseline, adjusted for baseline value||||6.38|-2.05|0.3134
71898233|NCT02202031|143319768|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.5146|TWO_SIDED|95.0|-7.05|3.53|||ANCOVA|change from baseline, adjusted for baseline value||||3.53|-7.05|0.5146
71898234|NCT02202031|143319769|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.3611|TWO_SIDED|95.0|-0.44|0.16|||ANCOVA|change from baseline, adjusted for baseline value||||0.16|-0.44|0.3611
71898235|NCT02202031|143319770|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6722|TWO_SIDED|95.0|-2.43|1.57|||ANCOVA|change from baseline, adjusted for baseline value||||1.57|-2.43|0.6722
71898236|NCT02202031|143319771|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0786|TWO_SIDED|95.0|-1.4|0.07|||ANCOVA|change from baseline, adjusted for baseline value||||0.07|-1.4|0.0786
71898237|NCT02202031|143319772|SUPERIORITY||Mean Difference (Final Values)|-1.04||||0.2284|TWO_SIDED|95.0|-2.87|0.79|||ANCOVA|change from baseline, adjusted for baseline value||||0.79|-2.87|0.2284
71898238|NCT02202031|143319773|SUPERIORITY||Mean Difference (Final Values)|-1.71||||0.0335|TWO_SIDED|95.0|-3.28|-0.13|||ANCOVA|change from baseline, adjusted for baseline value||||-0.13|-3.28|0.0335
71898239|NCT02202031|143319774|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.8408|TWO_SIDED|95.0|-0.66|0.81|||ANCOVA|change from baseline, adjusted for baseline value||||0.81|-0.66|0.8408
71898240|NCT02202031|143319775|SUPERIORITY|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|Mean Difference (Final Values)|0.14||||0.5578|TWO_SIDED|95.0|-0.32|0.6|||ANCOVA|||||0.60|-0.32|0.5578
71898241|NCT02202031|143319776|SUPERIORITY|||||||0.5578|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.5578
71898242|NCT02202031|143319777|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.7301|TWO_SIDED|95.0|-0.79|0.31|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||0.31|-0.79|0.7301
71898243|NCT02202031|143319778|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.6646|TWO_SIDED|95.0|-0.89|0.04|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic||||0.04|-0.89|0.6646
71898244|NCT02202031|143319779|SUPERIORITY|||||||0.4993|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||||0.4993
71898245|NCT02202031|143319780|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.7506|TWO_SIDED|95.0|-3.05|4.23|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||4.23|-3.05|0.7506
71898246|NCT02202031|143319781|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.6268|TWO_SIDED|95.0|-6.98|3.87|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.||||3.87|-6.98|0.6268
71814794|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.57||||0.011|TWO_SIDED|95.0|0.13|1.02||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.02|0.13|0.011
71814795|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||<|0.001|TWO_SIDED|95.0|1.68|2.99||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.99|1.68|<0.001
71898247|NCT00076219|143319782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.12||0.47|TWO_SIDED|95.0|0.86|1.4|||Regression, Logistic|||||1.40|0.86|0.47
71898248|NCT01276847|143319816|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.016
71898249|NCT01276847|143319816|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.007
71898250|NCT01276847|143319816|SUPERIORITY_OR_OTHER|||||||0.00015||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.00015
71898251|NCT01276847|143319816|SUPERIORITY_OR_OTHER|||||||0.000184||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000184
71898252|NCT01276847|143319817|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.397
71898253|NCT01276847|143319817|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.010
71898254|NCT01276847|143319817|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.002
71898255|NCT01276847|143319817|SUPERIORITY_OR_OTHER|||||||0.000215||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.000215
71898256|NCT01276847|143319818|SUPERIORITY_OR_OTHER|||||||0.787||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1||||0.787
71898257|NCT01276847|143319818|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2||||0.577
71898258|NCT01276847|143319818|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4||||0.053
71898259|NCT01276847|143319818|SUPERIORITY_OR_OTHER|||||||0.098||95.0||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16||||0.098
71898260|NCT01899144|143319819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|22.6|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|13.0|32.2|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||32.20|13.00|<0.0001
71898261|NCT01899144|143319819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.2|STANDARD_ERROR_OF_MEAN|4.87|<|0.0001|TWO_SIDED|95.0|11.6|30.81|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||30.81|11.6|<0.0001
71898262|NCT01899144|143319819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.7|STANDARD_ERROR_OF_MEAN|4.85|<|0.0001|TWO_SIDED|95.0|14.13|33.23|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||33.23|14.13|<0.0001
71898263|NCT01899144|143319819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|4.85||0.0107|TWO_SIDED|95.0|2.93|22.05|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||22.05|2.93|0.0107
71898264|NCT01899144|143319819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.88||0.7772|TWO_SIDED|95.0|-11.0|8.23||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||8.23|-11.00|0.7772
71898265|NCT01899144|143319819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|STANDARD_ERROR_OF_MEAN|4.87||0.0226|TWO_SIDED|95.0|-20.8|-1.59||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||-1.59|-20.80|0.0226
71898266|NCT01899144|143319820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
71898267|NCT01899144|143319820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.21|0.59|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.59|0.21|<0.0001
71898268|NCT01899144|143319820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.64|0.26|<0.0001
71898269|NCT01899144|143319820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1||0.0062|TWO_SIDED|95.0|0.08|0.45|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~* Albuterol MDPI 180 mcg to placebo~* Albuterol MDPI 90 mcg to placebo~* ProAir HFA 180 mcg to placebo~* ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."||0.45|0.08|0.0062
71678459|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4||||0.32|TWO_SIDED|95.0|0.06|2.43|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.43|0.06|0.32
71678460|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|95.0|0.21|2.61|||Regression, Logistic|||||2.61|0.21|0.65
71898270|NCT01899144|143319820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6342|TWO_SIDED|95.0|-0.23|0.14||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.14|-0.23|0.6342
71678461|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.39|TWO_SIDED|95.0|0.13|2.19|||Regression, Logistic|||||2.19|0.13|0.39
71678462|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.41||||0.22|TWO_SIDED|95.0|0.1|1.67|||Regression, Logistic|||||1.67|0.10|0.22
71678463|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.22||||0.082|TWO_SIDED|95.0|0.04|1.22|||Regression, Logistic|||||1.22|0.04|0.082
71678464|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.36||||0.36|TWO_SIDED|95.0|0.04|3.2|||Regression, Logistic|||||3.20|0.04|0.36
71678465|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.51|TWO_SIDED|95.0|0.42|5.71|||Regression, Logistic|||||5.71|0.42|0.51
71898271|NCT01899144|143319820|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.0488|TWO_SIDED|95.0|-0.38|0.0||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis||0.00|-0.38|0.0488
71898272|NCT00751881|143319824|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|36.3||||0.0001|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between teriflunomide 14 mg and placebo~* H2: No difference between teriflunomide 7 mg and placebo~The study was sized to have 94% power to detect a 25% relative risk reduction in ARR with teriflunomide compared to placebo at a 2-sided 0.05 significance level."||||0.0001
71898273|NCT00751881|143319824|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|22.3||||0.0183|TWO_SIDED|95.0||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 7 mg compared to placebo|||||0.0183
71898274|NCT00751881|143319825|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|31.5||||0.0442|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* S1: No difference between teriflunomide 14 mg and placebo~* S2: No difference between teriflunomide 7 mg and placebo~The study was also sized to have 75% power to detect a 37% hazard ratio reduction in time to disability progression with teriflunomide compared to placebo."||||0.0442
71898275|NCT00751881|143319825|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|4.5||||0.762|TWO_SIDED|95.0||||"Step down approach:~* S1 tested only if both comparisons on the primary outcome measure were statistically significant~* S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.7620
71898276|NCT03415464|143319858|OTHER|||||||0.134|||||||Chi-squared|||||||0.134
71898277|NCT02273323|143319867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.43|TWO_SIDED|0.23|-0.37|0.83|||Mixed Models Analysis|||Estimated effect of tea vs placebo||0.83|-0.37|0.43
71898278|NCT02273323|143319868|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.2|TWO_SIDED|95.0|-0.4|1.82|||Mixed Models Analysis|Subject=random factor; treatment, on/off medication, period = fixed effects||Estimated effect of tea vs. placebo||1.82|-0.40|0.20
71898279|NCT02273323|143319869|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35|||||TWO_SIDED|95.0|-5.26|2.55|||Mixed Models Analysis|||||2.55|-5.26|
71898280|NCT02273323|143319870|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.16|1.37|||Mixed Models Analysis|||||1.37|-2.16|
71678466|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.19|5.36|||Regression, Logistic|||||5.36|0.19|0.99
71678467|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.96|TWO_SIDED|95.0|0.24|4.59|||Regression, Logistic|||||4.59|0.24|0.96
71678468|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.62||||0.57|TWO_SIDED|95.0|0.12|3.3|||Regression, Logistic|||||3.30|0.12|0.57
71898281|NCT02273323|143319871|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|||||TWO_SIDED|95.0|-4.65|0.87|||Mixed Models Analysis|||||0.87|-4.65|
71898282|NCT02273323|143319872|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||||TWO_SIDED|95.0|-0.73|4.09|||Mixed Models Analysis|||||4.09|-0.73|
71898283|NCT03117049|143319876|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|96.37|0.43|0.71|||Stratified log-rank test|||||0.71|0.43|<0.0001
71898284|NCT03117049|143319877|SUPERIORITY||Stratified hazard ratio|0.85|||||TWO_SIDED|95.0|0.63|1.14||||||||1.14|0.63|
71898285|NCT03117049|143319878|SUPERIORITY||Odds Ratio (OR)|1.55|||||TWO_SIDED|95.0|1.11|2.17||||||||2.17|1.11|
71898286|NCT03117049|143319879|SUPERIORITY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.46|1.31||||||||1.31|0.46|
71898287|NCT00839098|143319882|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
71898288|NCT00839098|143319883|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71898289|NCT00839098|143319884|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71898290|NCT00839098|143319885|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71678469|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.93|TWO_SIDED|95.0|0.28|3.95|||Regression, Logistic|||||3.95|0.28|0.93
71678470|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.42||||0.37|TWO_SIDED|95.0|0.06|2.79|||Regression, Logistic|||||2.79|0.06|0.37
71898291|NCT00839098|143319886|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71898292|NCT00839098|143319887|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||P values below 0.05 were considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||||||>0.05
71898293|NCT00839098|143319888|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71898294|NCT00121810|143319889|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.7||||0.012||95.0|4.2|33.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.||33.2|4.2|0.012
71678471|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.74|TWO_SIDED|95.0|0.2|3.13|||Regression, Logistic|||||3.13|0.20|0.74
71898295|NCT00121810|143319890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.543||95.0|-9.6|18.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||||18.2|-9.6|0.543
71898296|NCT00121810|143319891|SUPERIORITY_OR_OTHER||Median Difference (Net)|-10.8||||0.003||95.0|-17.9|-3.7||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||-3.7|-17.9|0.003
71898297|NCT00121810|143319891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.0||||0.108||95.0|-35.4|3.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||3.5|-35.4|0.108
71678472|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.57||||0.46|TWO_SIDED|95.0|0.12|2.59|||Regression, Logistic|||||2.59|0.12|0.46
71898298|NCT00121810|143319891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.4||||0.039||95.0|-47.7|-1.2||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||-1.2|-47.7|0.039
71898299|NCT00121810|143319892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7|||<|0.001||95.0|4.1|13.3||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||13.3|4.1|<0.001
71898300|NCT00121810|143319892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.9||||0.029||95.0|0.7|13.1||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||13.1|0.7|0.029
71898301|NCT00121810|143319892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||0.015||95.0|1.7|15.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||15.9|1.7|0.015
71898302|NCT00121810|143319893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5|||<|0.001||95.0|4.2|12.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months||12.9|4.2|<0.001
71898303|NCT00121810|143319893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8||||0.059||95.0|-0.2|11.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months||11.9|-0.2|0.059
71898304|NCT00121810|143319893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5||||0.036||95.0|0.5|14.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months||14.5|0.5|0.036
71898305|NCT02260193|143319906|SUPERIORITY||Least Squares Mean Differences|0.29|||||TWO_SIDED|95.0|-0.25|0.82||||||||0.82|-0.25|
71898306|NCT02260193|143319906|SUPERIORITY||Least Squares Mean Differences|0.36|||||TWO_SIDED|95.0|-0.19|0.9||||||||0.90|-0.19|
71898307|NCT02260193|143319906|SUPERIORITY||Least Squares Mean Differences|0.07|||||TWO_SIDED|95.0|-0.48|0.61||||||||0.61|-0.48|
71678473|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.44||||0.28|TWO_SIDED|95.0|0.1|1.96|||Regression, Logistic|||||1.96|0.10|0.28
71678474|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.23||||0.11|TWO_SIDED|95.0|0.04|1.4|||Regression, Logistic|||||1.40|0.04|0.11
71678475|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.4|TWO_SIDED|95.0|0.04|3.66|||Regression, Logistic|||||3.66|0.04|0.40
71898308|NCT02260193|143319907|SUPERIORITY||Least Squares Mean Differences|0.04|||||TWO_SIDED|95.0|-0.54|0.61||||||||0.61|-0.54|
71898309|NCT02260193|143319907|SUPERIORITY||Least Squares Mean Differences|0.1|||||TWO_SIDED|95.0|-0.49|0.7||||||||0.70|-0.49|
71898310|NCT02260193|143319907|SUPERIORITY||Least squares mean difference|0.07|||||TWO_SIDED|95.0|-0.53|0.66||||||||0.66|-0.53|
71898311|NCT02260193|143319908|SUPERIORITY||Least squares mean difference|-0.34|||||TWO_SIDED|95.0|-0.71|0.04||||||||0.04|-0.71|
71898312|NCT02260193|143319908|SUPERIORITY||Least squares mean difference|-0.11|||||TWO_SIDED|95.0|-0.5|0.29||||||||0.29|-0.50|
71678476|NCT01340027|142875315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.5|TWO_SIDED|95.0|0.39|6.85|||Regression, Logistic|||||6.85|0.39|0.50
71898313|NCT02260193|143319908|SUPERIORITY||Least squares mean difference|0.23|||||TWO_SIDED|95.0|-0.16|0.62||||||||0.62|-0.16|
71898314|NCT02389946|143319930|NON_INFERIORITY|Non-inferiority of the 12-month TLF rate for the Orsiro stent vs. the Xience stent was assessed as the primary endpoint. The null hypothesis H0 was that the Orsiro stent would have a primary endpoint (12-month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis HA was that the Orsiro stent would have a 12-month TLF rate less than the Xience group rate plus the non-inferiority margin of 3.85%.|Posterior Probability of non-inferioriry|100.0|||||TWO_SIDED|||||||||Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.||||
71898315|NCT02389946|143319931|OTHER|||||||0.415|||||||Fisher Exact|||||||0.415
71898316|NCT01377467|143319940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.059|STANDARD_ERROR_OF_MEAN|0.967|<|0.001|TWO_SIDED|95.0|3.137|6.98|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.||6.980|3.137|<0.001
71898317|NCT01377467|143319941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.895|STANDARD_ERROR_OF_MEAN|0.887||0.035|TWO_SIDED|95.0|0.132|3.659|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.659|0.132|0.035
71898318|NCT01377467|143319942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.059|STANDARD_ERROR_OF_MEAN|1.201||0.38|TWO_SIDED|95.0|-1.329|3.447|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.447|-1.329|0.380
71898319|NCT01377467|143319943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.567|STANDARD_ERROR_OF_MEAN|0.806|<|0.001|TWO_SIDED|95.0|2.975|6.178|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||6.178|2.975|<0.001
71678477|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.47||0.21|TWO_SIDED|95.0|-8.0|1.7|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||1.7|-8.0|0.21
71678478|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|2.03||0.54|TWO_SIDED|95.0|-5.2|2.7|||ANCOVA|||||2.7|-5.2|0.54
71678479|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|2.03||0.016|TWO_SIDED|95.0|-8.9|-0.9|||ANCOVA|||||-0.9|-8.9|0.016
71678480|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.2|STANDARD_ERROR_OF_MEAN|2.05||0.011|TWO_SIDED|95.0|-9.3|-1.2|||ANCOVA|||||-1.2|-9.3|0.011
71678481|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-10.7|-2.8|||ANCOVA|||||-2.8|-10.7|<0.001
71678482|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|2.43||0.005|TWO_SIDED|95.0|-11.6|-2.0|||ANCOVA|||||-2.0|-11.6|0.005
71678483|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|2.44||0.056|TWO_SIDED|95.0|-9.4|0.1|||ANCOVA|||||0.1|-9.4|0.056
71678484|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.81||0.56|TWO_SIDED|95.0|-7.1|3.9|||ANCOVA|||||3.9|-7.1|0.56
71678485|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.8||0.48|TWO_SIDED|95.0|-7.5|3.5|||ANCOVA|||||3.5|-7.5|0.48
71678486|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|0.13||0.13|TWO_SIDED|95.0|-9.8|1.2|||ANCOVA|||||1.2|-9.8|0.13
71678487|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.42||0.61|TWO_SIDED|95.0|-6.0|3.5|||ANCOVA|||||3.5|-6.0|0.61
71678488|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|2.81||0.12|TWO_SIDED|95.0|-9.9|1.2|||ANCOVA|||||1.2|-9.9|0.12
71678489|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.44||0.31|TWO_SIDED|95.0|-7.3|2.3|||ANCOVA|||||2.3|-7.3|0.31
71678490|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|2.44||0.012|TWO_SIDED|95.0|-10.9|-1.3|||ANCOVA|||||-1.3|-10.9|0.012
71678491|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|2.46||0.008|TWO_SIDED|95.0|-11.3|-1.7|||ANCOVA|||||-1.7|-11.3|0.008
71898320|NCT01377467|143319944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.756|STANDARD_ERROR_OF_MEAN|0.662||0.009|TWO_SIDED|95.0|0.44|3.072|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||3.072|0.440|0.009
71678492|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.44||0.001|TWO_SIDED|95.0|-12.8|-3.2|||ANCOVA|||||-3.2|-12.8|0.001
71678493|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.78||0.004|TWO_SIDED|95.0|-13.5|-2.6|||ANCOVA|||||-2.6|-13.5|0.004
71678494|NCT01340027|142875316|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|2.79||0.035|TWO_SIDED|95.0|-11.4|-0.4|||ANCOVA|||||-0.4|-11.4|0.035
71678495|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.4|TWO_SIDED|95.0|0.63|3.2|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||3.20|0.63|0.40
71898321|NCT01377467|143319945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.035|STANDARD_ERROR_OF_MEAN|1.085||0.064|TWO_SIDED|95.0|-0.122|4.193|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|||4.193|-0.122|0.064
71898322|NCT01377467|143319946|SUPERIORITY_OR_OTHER||between-subjects effect|10.466|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p=0.007. Time\*treatment interaction: p=0.002. The a priori threshold for statistical significance is \<0.05.|||||<0.001
71898323|NCT01377467|143319947|SUPERIORITY_OR_OTHER||between-subjects effect|275622.016|||<|0.001|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.012. The a priori threshold for statistical significance is \<0.05.|||||<0.001
71898324|NCT01377467|143319948|SUPERIORITY_OR_OTHER||between-subjects effect|0.717||||0.014|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p\<0.001. The a priori threshold for statistical significance is \<0.05.|||||0.014
71898325|NCT01377467|143319949|SUPERIORITY_OR_OTHER||between-subjects effect|0.707||||0.068|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.068
71898326|NCT01377467|143319950|SUPERIORITY_OR_OTHER||between-subjects effect|99952.126||||0.114|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.047. The a priori threshold for statistical significance is \<0.05.|||||0.114
71678496|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.89|TWO_SIDED|95.0|0.55|1.97|||Regression, Logistic|||||1.97|0.55|0.89
71846475|NCT02434328|143207440|OTHER||Difference in proportions|7.7|||||TWO_SIDED|95.0|0.9|14.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20||14.8|0.9|
71846476|NCT02434328|143207440|OTHER||Difference in proportions|-20.0|||||TWO_SIDED|95.0|-27.3|-13.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24||-13.1|-27.3|
71846477|NCT02434328|143207440|OTHER||Difference in proportions|-3.9|||||TWO_SIDED|95.0|-10.4|2.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28||2.4|-10.4|
71846478|NCT02434328|143207440|OTHER||Difference in proportions|-9.7|||||TWO_SIDED|95.0|-16.7|-2.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32||-2.5|-16.7|
71846479|NCT02434328|143207440|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-15.8|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36||-3.4|-15.8|
71846480|NCT02434328|143207440|OTHER||Difference in proportions|-16.5|||||TWO_SIDED|95.0|-23.4|-9.6||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40||-9.6|-23.4|
71846481|NCT02434328|143207440|OTHER||Difference in proportions|3.4|||||TWO_SIDED|95.0|-3.3|10.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44||10.4|-3.3|
71846482|NCT02434328|143207440|OTHER||Difference in proportions|-18.1|||||TWO_SIDED|95.0|-24.9|-11.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48||-11.8|-24.9|
71846483|NCT02434328|143207440|OTHER||Difference in proportions|-3.0|||||TWO_SIDED|95.0|-9.2|3.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52||3.2|-9.2|
71678497|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.57|TWO_SIDED|95.0|0.63|2.33|||Regression, Logistic|||||2.33|0.63|0.57
71846484|NCT02434328|143207440|OTHER||Difference in proportions|-9.4|||||TWO_SIDED|95.0|-16.3|-2.8||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56||-2.8|-16.3|
71846485|NCT02434328|143207440|OTHER||Difference in proportions|-5.7|||||TWO_SIDED|95.0|-12.5|1.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60||1.1|-12.5|
71898327|NCT01377467|143319951|SUPERIORITY_OR_OTHER||between-subjects effect|84.83||||0.578|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.593. The a priori threshold for statistical significance is \<0.05.|||||0.578
71898328|NCT01377467|143319952|SUPERIORITY_OR_OTHER||between-subjects effect|248.686||||0.607|TWO_SIDED||||||repeated measures GLM||Within-subjects effect: p\<0.001. Time\*treatment interaction: p=0.296. The a priori threshold for statistical significance is \<0.05.|||||0.607
71898329|NCT01377467|143319953|SUPERIORITY_OR_OTHER||z value|-2.342||||0.019|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.019
71898330|NCT01377467|143319954|SUPERIORITY_OR_OTHER||z value|-2.049||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
71898331|NCT01377467|143319955|SUPERIORITY_OR_OTHER||z value|-0.937||||0.371|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.371
71898332|NCT01377467|143319956|SUPERIORITY_OR_OTHER||z value|-2.752||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
71898333|NCT01377467|143319957|SUPERIORITY_OR_OTHER||z value|-2.166||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
71898334|NCT01377467|143319958|SUPERIORITY_OR_OTHER||z value|-1.288||||0.212|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.212
71898335|NCT01377467|143319959|SUPERIORITY_OR_OTHER||z value|-1.64||||0.108|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.108
71898336|NCT01377467|143319960|SUPERIORITY_OR_OTHER||z value|-1.991||||0.048|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.048
71898337|NCT01354691|143319961|SUPERIORITY||||||<|0.67|||||||ANCOVA|||||||<0.67
71898338|NCT01354691|143319962|SUPERIORITY||||||<|0.21|||||||ANCOVA|||||||<0.21
71898339|NCT01354691|143319963|SUPERIORITY||||||<|0.78|||||||ANCOVA|||||||<0.78
71898340|NCT01354691|143319964|SUPERIORITY||||||=|0.83|||||||ANCOVA|||||||=0.83
71898341|NCT01354691|143319965|SUPERIORITY||||||=|0.77|||||||ANCOVA|||||||=.77
71898342|NCT00633139|143319966|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4013|TWO_SIDED||||||ANCOVA|||||||0.4013
71898343|NCT00633139|143319967|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|TWO_SIDED|95.0|||||ANCOVA|||||||0.2750
71898344|NCT00633139|143319968|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1363|TWO_SIDED|95.0|||||ANCOVA|||||||0.1363
71898345|NCT04430582|143319969|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
71898346|NCT04430582|143319970|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71898347|NCT04430582|143319971|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71898348|NCT04430582|143319972|OTHER|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.51
71898349|NCT04430582|143319973|OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||||||0.70
71898350|NCT04430582|143319974|OTHER|||||||0.95|||||||Kruskal-Wallis|||||||0.95
71898351|NCT04430582|143319975|OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71898352|NCT04430582|143319976|OTHER|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
71898353|NCT04430582|143319977|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71898354|NCT04430582|143319978|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71898355|NCT04430582|143319979|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71898356|NCT04430582|143319980|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71898357|NCT04430582|143319981|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
71898358|NCT04430582|143319982|OTHER|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||||||0.045
71898359|NCT04430582|143319983|OTHER|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71898360|NCT00410280|143319985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.0947|TWO_SIDED|95.0|-14.04|1.15|||ANOVA|||Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.||1.15|-14.04|0.0947
71898361|NCT00410280|143319986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24||||0.2673|TWO_SIDED|95.0|-11.84|3.35|||ANOVA|||Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.35|-11.84|0.2673
71898362|NCT00410280|143319987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8||||0.0391|TWO_SIDED|95.0|-46.35|-1.24|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.24|-46.35|0.0391
71898363|NCT00410280|143319987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.17||||0.1326|TWO_SIDED|95.0|-39.72|5.39|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.39|-39.72|0.1326
71898364|NCT00410280|143319988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76||||0.0423|TWO_SIDED|95.0|-19.16|-0.35|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-0.35|-19.16|0.0423
71898365|NCT00410280|143319988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.06||||0.3902|TWO_SIDED|95.0|-13.46|5.35|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||5.35|-13.46|0.3902
71898366|NCT00410280|143319989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05||||0.0302|TWO_SIDED|95.0|-36.21|-1.9|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||-1.90|-36.21|0.0302
71898367|NCT00410280|143319989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.19||||0.1289|TWO_SIDED|95.0|-30.34|3.97|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.||3.97|-30.34|0.1289
71898368|NCT00410280|143319990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8469|TWO_SIDED|95.0|-0.79|0.96|||Mixed Models Analysis|||Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.96|-0.79|0.8469
71898369|NCT00410280|143319990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9995|TWO_SIDED|95.0|-0.86|0.86|||Mixed Models Analysis|||Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.86|-0.86|0.9995
71898370|NCT00410280|143319990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.528|TWO_SIDED|95.0|-1.14|0.59|||Mixed Models Analysis|||Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.||0.59|-1.14|0.5280
71814796|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.49||||0.071|TWO_SIDED|95.0|-0.04|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.03|-0.04|0.071
71846486|NCT02434328|143207440|OTHER||Difference in proportions|-15.5|||||TWO_SIDED|95.0|-21.9|-8.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64||-8.5|-21.9|
71846487|NCT02434328|143207440|OTHER||Difference in proportions|0.9|||||TWO_SIDED|95.0|-5.9|7.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68||7.5|-5.9|
71814797|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|1.84|||<|0.001|TWO_SIDED|95.0|1.19|2.5||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.50|1.19|<0.001
71814798|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|3.37|||<|0.001|TWO_SIDED|95.0|2.67|4.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.06|2.67|<0.001
71814799|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.77||||0.008|TWO_SIDED|95.0|0.2|1.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.33|0.20|0.008
71814800|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||<|0.001|TWO_SIDED|95.0|1.91|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.91|<0.001
71814801|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||<|0.001|TWO_SIDED|95.0|2.92|4.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.43|2.92|<0.001
71814802|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.69||||0.028|TWO_SIDED|95.0|0.07|1.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.30|0.07|0.028
71814803|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.74|2.24|<0.001
71814804|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|3.75|||<|0.001|TWO_SIDED|95.0|2.9|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.59|2.90|<0.001
71846488|NCT02434328|143207440|OTHER||Difference in proportions|-14.9|||||TWO_SIDED|95.0|-21.4|-8.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72||-8.1|-21.4|
71678498|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.36||||0.36|TWO_SIDED|95.0|0.7|2.66|||Regression, Logistic|||||2.66|0.70|0.36
71814805|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.82||||0.02|TWO_SIDED|95.0|0.13|1.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.51|0.13|0.020
71814806|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.93|||<|0.001|TWO_SIDED|95.0|2.09|3.77||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.77|2.09|<0.001
71814807|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|3.38|||<|0.001|TWO_SIDED|95.0|2.46|4.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.30|2.46|<0.001
71678499|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.66||||0.15|TWO_SIDED|95.0|0.83|3.32|||Regression, Logistic|||||3.32|0.83|0.15
71678500|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.31|TWO_SIDED|95.0|0.67|3.59|||Regression, Logistic|||||3.59|0.67|0.31
71678501|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.81|TWO_SIDED|95.0|0.42|1.95|||Regression, Logistic|||||1.95|0.42|0.81
71678502|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75||||0.19|TWO_SIDED|95.0|0.75|4.08|||Regression, Logistic|||||4.08|0.75|0.19
71678503|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.59|TWO_SIDED|95.0|0.56|2.77|||Regression, Logistic|||||2.77|0.56|0.59
71678504|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.97||||0.13|TWO_SIDED|95.0|0.83|4.71|||Regression, Logistic|||||4.71|0.83|0.13
71678505|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.2|TWO_SIDED|95.0|0.78|3.16|||Regression, Logistic|||||3.16|0.78|0.20
71678506|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.07|TWO_SIDED|95.0|0.94|5.34|||Regression, Logistic|||||5.34|0.94|0.070
71898371|NCT01522651|143320006|OTHER|Pairwise Comparative analysis|Percentage Difference|-19.8|STANDARD_ERROR_OF_MEAN|25.7||0.493|TWO_SIDED|95.0|-57.5|51.5||An equal-slopes analysis of covariance (ANCOVA) model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||51.5|-57.5|0.493
71678507|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.64||||0.17|TWO_SIDED|95.0|0.81|3.33|||Regression, Logistic|||||3.33|0.81|0.17
71678508|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.084|TWO_SIDED|95.0|0.92|3.92|||Regression, Logistic|||||3.92|0.92|0.084
71678509|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.14||||0.043|TWO_SIDED|95.0|1.02|4.48|||Regression, Logistic|||||4.48|1.02|0.043
71678510|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61||||0.013|TWO_SIDED|95.0|1.22|5.58|||Regression, Logistic|||||5.58|1.22|0.013
71898372|NCT01522651|143320006|OTHER|Pairwise Comparative analysis|Percentage Difference|8.8|STANDARD_ERROR_OF_MEAN|32.9||0.78|TWO_SIDED|95.0|-40.2|98.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||98.2|-40.2|0.780
71678511|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.43||||0.053|TWO_SIDED|95.0|0.99|5.97|||Regression, Logistic|||||5.97|0.99|0.053
71678512|NCT01340027|142875317|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.39|TWO_SIDED|95.0|0.63|3.26|||Regression, Logistic|||||3.26|0.63|0.39
71678513|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|2.55||0.26|TWO_SIDED|95.0|-2.1|7.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||7.9|-2.1|0.26
71678514|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.1||0.38|TWO_SIDED|95.0|-2.3|6.0|||ANCOVA|||||6.0|-2.3|0.38
71678515|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differrence|4.8|STANDARD_ERROR_OF_MEAN|2.1||0.022|TWO_SIDED|95.0|0.7|8.9|||ANCOVA|||||8.9|0.7|0.022
71678516|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.5|STANDARD_ERROR_OF_MEAN|2.12||0.01|TWO_SIDED|95.0|1.3|9.7|||ANCOVA|||||9.7|1.3|0.010
71678517|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.4|STANDARD_ERROR_OF_MEAN|2.09||0.002|TWO_SIDED|95.0|2.3|10.5|||ANCOVA|||||10.5|2.3|0.002
71678518|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|2.52||0.008|TWO_SIDED|95.0|1.7|11.6|||ANCOVA|||||11.6|1.7|0.008
71678519|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.52||0.037|TWO_SIDED|95.0|0.3|10.2|||ANCOVA|||||10.2|0.3|0.037
71678520|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.9||0.5|TWO_SIDED|95.0|-7.7|3.7|||ANCOVA|||||3.7|-7.7|0.50
71678521|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.89||0.65|TWO_SIDED|95.0|-4.4|7.0|||ANCOVA|||||7.0|-4.4|0.65
71678522|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|2.88||0.25|TWO_SIDED|95.0|-2.4|8.9|||ANCOVA|||||8.9|-2.4|0.25
71678523|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|2.51||0.76|TWO_SIDED|95.0|-5.7|4.1|||ANCOVA|||||4.1|-5.7|0.76
71898373|NCT01522651|143320006|OTHER|Pairwise Comparative analysis|Percentage Difference|-57.0|STANDARD_ERROR_OF_MEAN|13.4||0.008|TWO_SIDED|95.0|-76.8|-20.1||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||-20.1|-76.8|0.008
71678524|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|2.91||0.47|TWO_SIDED|95.0|-3.6|7.8|||ANCOVA|||||7.8|-3.6|0.47
71678525|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|2.52||0.67|TWO_SIDED|95.0|-3.9|6.0|||ANCOVA|||||6.0|-3.9|0.67
71678526|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED|95.0|-0.9|9.0|||ANCOVA|||||9.0|-0.9|0.11
71678527|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.54||0.062|TWO_SIDED|95.0|-0.2|9.7|||ANCOVA|||||9.7|-0.2|0.062
71678528|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|2.52||0.025|TWO_SIDED|95.0|0.7|10.6|||ANCOVA|||||10.6|0.7|0.025
71898374|NCT01522651|143320006|OTHER|Pairwise Comparative analysis|Percentage Difference|-42.6|STANDARD_ERROR_OF_MEAN|17.5||0.072|TWO_SIDED|95.0|-68.7|5.2||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||5.2|-68.7|0.072
71898375|NCT01522651|143320006|OTHER|Pairwise Comparative analysis||||||0.315||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.315
71898376|NCT01522651|143320006|OTHER|Pairwise Comparative analysis||||||0.049||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.049
71898377|NCT01522651|143320006|OTHER|Pairwise Comparative analysis||||||0.275||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.275
71898378|NCT01522651|143320006|OTHER|Pairwise Comparative analysis||||||0.002||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.002
71898379|NCT01522651|143320006|OTHER|Pairwise Comparative analysis||||||0.028||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.028
71898380|NCT01522651|143320006|OTHER|Pairwise Comparative analysis||||||0.334||||||An equal-slopes ANCOVA model was fitted to log-transformed AFB over 12 weeks, with baseline AFB as the covariate. AFB values \< 1% (\> 99%) were set to 1% (99%) before transformation.|ANCOVA|||||||0.334
71898381|NCT02658656|143320009|SUPERIORITY||Risk Ratio (RR)|0.91||||0.798|TWO_SIDED|95.0|0.45|1.85|||Chi-squared|||||1.85|.45|0.798
71898382|NCT02658656|143320010|SUPERIORITY||Risk Ratio (RR)|0.97||||0.935|TWO_SIDED|95.0|0.44|2.15|||Chi-squared|||||2.15|0.44|0.935
71898383|NCT02658656|143320011|SUPERIORITY||Risk Ratio (RR)|0.93||||0.829|TWO_SIDED|95.0|0.49|1.79|||Chi-squared|||||1.79|0.49|0.829
71898384|NCT02658656|143320012|SUPERIORITY||Risk Ratio (RR)|1.09||||0.809|TWO_SIDED|95.0|0.56|2.11|||Chi-squared|||||2.11|0.56|0.809
71898385|NCT02658656|143320013|SUPERIORITY||Risk Ratio (RR)|1.15||||0.717|TWO_SIDED|95.0|0.54|2.47|||Chi-squared|||||2.47|0.54|0.717
71898386|NCT02658656|143320014|SUPERIORITY||Risk Ratio (RR)|1.11||||0.738|TWO_SIDED|95.0|0.61|2.02|||Chi-squared|||||2.02|0.61|0.738
71898387|NCT01850563|143320064|OTHER||Hazard Ratio (HR)|0.87||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
71898388|NCT01850563|143320066|OTHER||Hazard Ratio (HR)|0.82||||0.76|TWO_SIDED||||||Kaplan-Meier|||||||0.76
71898389|NCT00408421|143320098|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).||||<0.001
71898390|NCT00408421|143320099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.001||95.0|-0.84|-0.21||Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|ANCOVA|||An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.||-0.21|-0.84|0.001
71898391|NCT00408421|143320100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.003||95.0|-2.33|-0.48||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.48|-2.33|0.003
71898392|NCT00408421|143320101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.004||95.0|-1.09|-0.22||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.22|-1.09|0.004
71898393|NCT00408421|143320102|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.18||||0.001||95.0|-8.33|-2.03||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.03|-8.33|0.001
71898394|NCT00408421|143320103|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.42||||0.004||95.0|-10.72|-2.11||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-2.11|-10.72|0.004
71898395|NCT00408421|143320104|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.83||||0.005||95.0|-1.4|-0.25||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.25|-1.40|0.005
71898396|NCT00408421|143320105|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||||||<0.001
71898397|NCT00408421|143320106|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.039||95.0|-1.69|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.69|0.039
71898398|NCT00408421|143320107|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.001||95.0|-0.56|-0.14||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.14|-0.56|0.001
71898399|NCT00408421|143320108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.06|||<|0.001||95.0|-1.66|-0.46||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.46|-1.66|<0.001
71898400|NCT00408421|143320109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.004||95.0|-1.28|-0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.24|-1.28|0.004
71898401|NCT00408421|143320110|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|||<|0.001||95.0|-1.52|-0.42||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.42|-1.52|<0.001
71898402|NCT00408421|143320111|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.003||95.0|-1.5|-0.32||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.32|-1.50|0.003
71898403|NCT00408421|143320112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.019||95.0|-1.3|-0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.12|-1.30|0.019
71678529|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|2.88||0.041|TWO_SIDED|95.0|0.2|11.5|||ANCOVA|||||11.5|0.2|0.041
71898404|NCT00408421|143320113|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.164||95.0|-0.97|0.17||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.17|-0.97|0.164
71898405|NCT00408421|143320114|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.049||95.0|-1.25|0.0||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.00|-1.25|0.049
71898406|NCT00408421|143320115|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51||||0.093||95.0|-1.1|0.08||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.08|-1.10|0.093
71898407|NCT00408421|143320116|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.287||95.0|-0.82|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-0.82|0.287
71898408|NCT00408421|143320117|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.033||95.0|-1.23|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.05|-1.23|0.033
71898409|NCT00408421|143320118|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.78||||0.015||95.0|-1.4|-0.15||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.15|-1.40|0.015
71898410|NCT00408421|143320119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.029||95.0|-1.06|-0.06||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||-0.06|-1.06|0.029
71814808|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|1.01||||0.009|TWO_SIDED|95.0|0.26|1.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.76|0.26|0.009
71898411|NCT00408421|143320120|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.033
71898412|NCT00408421|143320121|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.||||0.075
71898413|NCT00408421|143320122|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83||||0.088||95.0|-0.28|3.94||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.94|-0.28|0.088
71898414|NCT00408421|143320123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.87||||0.08||95.0|-0.22|3.96||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.96|-0.22|0.080
71898415|NCT00408421|143320124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||<|0.001||95.0|0.03|0.1||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.10|0.03|<0.001
71898416|NCT00408421|143320125|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.641||95.0|-1.19|0.74||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.74|-1.19|0.641
71898417|NCT00408421|143320126|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.193||95.0|-1.17|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.24|-1.17|0.193
71898418|NCT00408421|143320127|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.003
71898419|NCT00408421|143320128|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||||0.026
71898420|NCT00408421|143320129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.459||95.0|-1.32|2.92||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||2.92|-1.32|0.459
71898421|NCT00408421|143320130|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.09||||0.326||95.0|-1.1|3.28||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||3.28|-1.10|0.326
71898422|NCT00408421|143320131|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.16||||0.069||95.0|-0.25|6.56||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||6.56|-0.25|0.069
71898423|NCT00408421|143320132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.107||95.0|-1.2|0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.||0.12|-1.20|0.107
71898424|NCT02772965|143320133|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.08|TWO_SIDED|95.0|0.45|1.05|||Log Rank|||||1.05|0.45|0.08
71898425|NCT02772965|143320134|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.32|TWO_SIDED||||||Mixed Models Analysis|||||||0.32
71898426|NCT02772965|143320135|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.8||0.69|TWO_SIDED||||||Mixed Models Analysis|||||||0.69
71898427|NCT02772965|143320136|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.6||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
71898428|NCT02772965|143320137|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.9||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
71898429|NCT02772965|143320138|SUPERIORITY||Risk Ratio (RR)|0.71||||0.08|TWO_SIDED|95.0|0.49|1.04|||Chi-squared|||||1.04|0.49|0.08
71898430|NCT03478878|143320150|SUPERIORITY||Mean Difference (Final Values)|1.83||||0.705|TWO_SIDED|95.0|-9.43|13.11||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 2 for Cohort 1)."||13.11|-9.43|0.705
71898431|NCT03478878|143320150|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.577|TWO_SIDED|95.0|-27.43|31.02||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the treatment completion visit (Month 1 for Cohort 2)."||31.02|-27.43|0.577
71898432|NCT03478878|143320151|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.646|TWO_SIDED|95.0|-7.6|11.35||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 3 for Cohort 1)."||11.35|-7.60|0.646
71898433|NCT03478878|143320151|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.405|TWO_SIDED|95.0|-19.3|23.9||Result of statistical analyses were considered significant if the p-value from the two-sided test was \<0.05. No adjustments for multiplicity were made.|Student's paired t-test||The estimate was the difference in mean change in RIT between baseline and the treatment completion visit.|"Analysis: Student's paired t-test on study eyes alone at a two-sided Type I error rate of 5%.~Null hypothesis: the mean RIT at Baseline = the mean RIT at the post-treatment follow-up visit (Month 2 for Cohort 2)."||23.90|-19.30|0.405
71898434|NCT02238028|143320174|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Paired t-test,2 sided|||Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.||||<0.05
71898435|NCT02238028|143320175|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Paired t-test,2 sided|||||||<0.05
71898436|NCT02606045|143320208|SUPERIORITY||Mean Difference (Final Values)|46.0||||0.039|TWO_SIDED|95.0|2.0|90.0|||Mixed Models Analysis|||||90|2|0.039
71846489|NCT02434328|143207440|OTHER||Difference in proportions|-0.8|||||TWO_SIDED|95.0|-7.5|5.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76||5.4|-7.5|
71846490|NCT02434328|143207440|OTHER||Difference in proportions|-10.4|||||TWO_SIDED|95.0|-17.2|-3.4||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80||-3.4|-17.2|
71846491|NCT02434328|143207440|OTHER||Difference in proportions|-4.5|||||TWO_SIDED|95.0|-11.4|2.3||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84||2.3|-11.4|
71846492|NCT02434328|143207440|OTHER||Difference in proportions|-11.0|||||TWO_SIDED|95.0|-18.2|-4.1||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88||-4.1|-18.2|
71846493|NCT02434328|143207440|OTHER||Difference in proportions|-2.9|||||TWO_SIDED|95.0|-9.4|3.5||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92||3.5|-9.4|
71846494|NCT02434328|143207440|OTHER||Difference in proportions|-14.1|||||TWO_SIDED|95.0|-21.3|-7.2||Hypothesis testing not pre-specified.|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96||-7.2|-21.3|
71846495|NCT02294461|143207447|SUPERIORITY_OR_OTHER_LEGACY||Unstratified Cox Proportional Hazards|0.38|||<|0.0001|TWO_SIDED|95.0|0.27|0.52|||Hazard Ratio|||P-value is based on an unstratified log-rank test. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.52|0.27|<0.0001
71846496|NCT02294461|143207448|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.51|0.95||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had died at the analysis date were censored at date last known alive. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.95|0.51|0.0208
71846497|NCT02294461|143207449|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001||95.0|0.2|0.46||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had an rPFS event were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.||0.46|0.20|<0.0001
71898437|NCT02606045|143320209|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.998|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|||||0.7|-0.7|0.998
71898438|NCT02606045|143320210|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.168|TWO_SIDED|95.0|-1.0|5.8|||Mixed Models Analysis|||||5.8|-1.0|0.168
71898439|NCT02606045|143320211|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.055|TWO_SIDED|95.0|-4.9|0.1|||Mixed Models Analysis|||||0.1|-4.9|0.055
71898440|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.681|TWO_SIDED|95.0|-4.8|3.2|||Mixed Models Analysis|||||3.2|-4.8|0.681
71898441|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.633|TWO_SIDED|95.0|-12.4|7.6|||Mixed Models Analysis|||Role limitations of physical health||7.6|-12.4|0.633
71898442|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.362|TWO_SIDED|95.0|-5.7|15.3|||Mixed Models Analysis|||Role limitations of emotional health||15.3|-5.7|0.362
71898443|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.375|TWO_SIDED|95.0|-7.4|2.8|||Mixed Models Analysis|||Energy/fatigue||2.8|-7.4|0.375
71898444|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.068|TWO_SIDED|95.0|-0.3|7.4|||Mixed Models Analysis|||Emotional well-being||7.4|-0.3|0.068
71898445|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.189|TWO_SIDED|95.0|-2.3|11.3|||Mixed Models Analysis|||Social functioning||11.3|-2.3|0.189
71898446|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.489|TWO_SIDED|95.0|-9.2|4.5|||Mixed Models Analysis|||Pain||4.5|-9.2|0.489
71898447|NCT02606045|143320212|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.3|||Mixed Models Analysis|||General Health||4.3|-3.2|0.786
71898448|NCT02606045|143320213|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.098|TWO_SIDED|95.0|-2.3|0.2|||Mixed Models Analysis|||Physically Unhealthy Days||0.2|-2.3|0.098
71898449|NCT02606045|143320213|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.557|TWO_SIDED|95.0|-1.6|3.0|||Mixed Models Analysis|||Mentally Unhealthy Days||3.0|-1.6|0.557
71898450|NCT02606045|143320214|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.266|TWO_SIDED|95.0|0.8|2.7|||Mixed Models Analysis|||Cycle Severity Rating||2.7|0.8|0.266
71898451|NCT00907881|143320215|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Regression, Linear|Pearson correlation coefficient||||||0.0002
71678530|NCT01340027|142875318|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.88||0.12|TWO_SIDED|95.0|-1.2|10.1|||ANCOVA|||||10.1|-1.2|0.12
71678531|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.92|TWO_SIDED|95.0|0.52|2.08|||Regression, Logistic|||"All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."||2.08|0.52|0.92
71898452|NCT01671085|143320223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.49|||<|0.001|TWO_SIDED|90.0|-71.27|-29.7||P-value is for Day 43.|Mixed Effects Model Analysis|||||-29.70|-71.27|<0.001
71898453|NCT01671085|143320223|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.11|||<|0.001|TWO_SIDED|90.0|-65.91|-24.31||P-value is for Day 57.|Mixed Effects Models Analysis|||||-24.31|-65.91|<0.001
71898454|NCT00637273|143320224|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.131|<|0.0001|TWO_SIDED|95.0|0.37|0.89||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.89|0.37|<.0001
71898455|NCT00637273|143320224|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.131||0.0165|TWO_SIDED|95.0|0.06|0.57||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide \>90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.||0.57|0.06|0.0165
71898456|NCT00637273|143320225|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
71898457|NCT00637273|143320225|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of \<7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0015
71898458|NCT00637273|143320226|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||<.0001
71898459|NCT00637273|143320226|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0120
71898460|NCT00637273|143320227|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.1700
71898461|NCT00637273|143320227|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of \<=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||||0.0091
71898462|NCT00637273|143320228|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.416||0.0002|TWO_SIDED|95.0|0.72|2.35||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.35|0.72|0.0002
71898463|NCT00637273|143320228|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.415|<|0.0001|TWO_SIDED|95.0|4.28|5.91||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.91|4.28|<.0001
71678532|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.58|1.77|||Regression, Logistic|||||1.77|0.58|0.98
71678533|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.45|TWO_SIDED|95.0|0.7|2.23|||Regression, Logistic|||||2.23|0.70|0.45
71898464|NCT00637273|143320229|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|15.5|STANDARD_ERROR_OF_MEAN|4.95||0.0038|TWO_SIDED|95.0|5.7|25.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||25.2|5.7|0.0038
71898465|NCT00637273|143320229|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|4.98||0.3729|TWO_SIDED|95.0|-5.3|14.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||14.2|-5.3|0.3729
71898466|NCT00637273|143320230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|1.26||0.0055|TWO_SIDED|95.0|1.3|6.3||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||6.3|1.3|0.0055
71898467|NCT00637273|143320230|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.25||0.1117|TWO_SIDED|95.0|-0.5|4.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||4.5|-0.5|0.1117
71898468|NCT00637273|143320231|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-0.4|2.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||2.5|-0.4|0.1685
71898469|NCT00637273|143320231|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.75||0.1685|TWO_SIDED|95.0|-2.6|0.4||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.4|-2.6|0.1685
71678534|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.24|TWO_SIDED|95.0|0.79|2.53|||Regression, Logistic|||||2.53|0.79|0.24
71898470|NCT00637273|143320232|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|3.31||0.2686|TWO_SIDED|95.0|-2.8|10.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||10.2|-2.8|0.2686
71898471|NCT00637273|143320232|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.8|STANDARD_ERROR_OF_MEAN|3.3||0.0814|TWO_SIDED|95.0|0.3|13.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||13.2|0.3|0.0814
71898472|NCT00637273|143320233|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9546|TWO_SIDED|95.0|-1.6|1.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.5|-1.6|0.9546
71898473|NCT00637273|143320233|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.2|STANDARD_ERROR_OF_MEAN|0.79|<|0.0001|TWO_SIDED|95.0|2.6|5.7||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||5.7|2.6|<.0001
71898474|NCT00637273|143320234|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.04||0.9718|TWO_SIDED|95.0|0.93|1.08||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||1.08|0.93|0.9718
71678535|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.21||||0.012|TWO_SIDED|95.0|1.19|4.09|||Regression, Logistic|||||4.09|1.19|0.012
71678536|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.43||||0.32|TWO_SIDED|95.0|0.7|2.9|||Regression, Logistic|||||2.90|0.70|0.32
71846498|NCT02294461|143207450|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56||||0.2501|TWO_SIDED|95.0|0.21|1.52||P-value was based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not have an SRE were censored at the date of the last assessment indicating no evidence of SRE. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||1.52|0.21|0.2501
71846499|NCT02294461|143207451|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28||||0.002||95.0|0.12|0.66||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not start cytotoxic chemotherapy were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.||0.66|0.12|0.0020
71846500|NCT02294461|143207452|SUPERIORITY_OR_OTHER_LEGACY||Difference of response rate|55.8|||<|0.0001|TWO_SIDED|95.0|47.4|64.2||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel %|||||64.2|47.4|<0.0001
71846501|NCT02294461|143207453|SUPERIORITY_OR_OTHER_LEGACY||Difference in objective response rate|26.0|||<|0.0001|TWO_SIDED|95.0|14.7|37.4||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel|||When deriving the response category, it was based on the target, non-target and new lesions without confirming CR, PR, and Progressive disease (PD). Participants with no post baseline assessment were included in the category of Nonevaluable (NE). The best overall soft tissue objective response was defined as PR or CR based on the investigator assessments of target, non-target and new lesions while on the study treatment.||37.4|14.7|<0.0001
71846502|NCT00378898|143207492|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
71846503|NCT00089609|143207541|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||.02
71846504|NCT03559205|143207552|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.96|TWO_SIDED|95.0|-0.74|0.7|||t-test, 2 sided|||2 Week Analysis||0.70|-0.74|0.96
71846505|NCT03559205|143207553|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.9|TWO_SIDED|95.0|-2.31|2.04|||t-test, 2 sided|||Baseline||2.04|-2.31|0.90
71846506|NCT03559205|143207553|SUPERIORITY||Mean Difference (Final Values)|2.01||||0.21|TWO_SIDED|95.0|-1.17|5.19|||t-test, 2 sided|||2 Week Analysis||5.19|-1.17|0.21
71846507|NCT03559205|143207553|SUPERIORITY||Mean Difference (Final Values)|0.94||||0.63|TWO_SIDED|95.0|-2.95|4.83|||t-test, 2 sided|||3-Month||4.83|-2.95|0.63
71846508|NCT03559205|143207554|SUPERIORITY||Mean Difference (Final Values)|2.63||||0.15|TWO_SIDED|95.0|-1.0|6.26|||t-test, 2 sided|||Baseline||6.26|-1.00|0.15
71846509|NCT03559205|143207554|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3|TWO_SIDED|95.0|-2.02|6.45|||t-test, 2 sided|||Week 2 analysis||6.45|-2.02|0.30
71846510|NCT03559205|143207554|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.85|TWO_SIDED|95.0|-4.89|5.9|||t-test, 2 sided|||3-Month||5.90|-4.89|0.85
71846511|NCT03559205|143207555|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.72|TWO_SIDED|95.0|-0.51|0.74|||t-test, 2 sided|||Care and respect||0.74|-0.51|0.72
71678537|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.27|TWO_SIDED|95.0|0.72|3.14|||Regression, Logistic|||||3.14|0.72|0.27
71846512|NCT03559205|143207555|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.46|TWO_SIDED|95.0|-0.38|0.83|||t-test, 2 sided|||Understanding \& engagement||0.83|-0.38|0.46
71846513|NCT03559205|143207556|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.3|TWO_SIDED|95.0|-0.13|0.42|||t-test, 2 sided|||2-weeks||0.42|-0.13|0.30
71846514|NCT03559205|143207556|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.38|TWO_SIDED|95.0|-0.2|0.52|||t-test, 2 sided|||3-months||0.52|-0.20|0.38
71846515|NCT03559205|143207557|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.61|TWO_SIDED|95.0|-1.48|0.88|||t-test, 2 sided|||||0.88|-1.48|0.61
71678538|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5||||0.064|TWO_SIDED|95.0|0.24|1.04|||Regression, Logistic|||||1.04|0.24|0.064
71678539|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.57|TWO_SIDED|95.0|0.59|2.61|||Regression, Logistic|||||2.61|0.59|0.57
71678540|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.55|TWO_SIDED|95.0|0.59|2.68|||Regression, Logistic|||||2.68|0.59|0.55
71846516|NCT04237792|143207562|OTHER||Odds Ratio (OR)|0.1|||<|0.001|TWO_SIDED|95.0|0.03|0.29|||Cochran-Mantel-Haenszel|||||0.29|0.03|<0.001
71846517|NCT04237792|143207563|OTHER||Odds Ratio (OR)|0.18||||0.022|TWO_SIDED|95.0|0.04|0.82|||Mantel Haenszel|||||0.82|0.04|0.022
71846518|NCT04237792|143207563|OTHER||Odds Ratio (OR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.26|||Mantel Haenszel|||||0.26|0.01|<0.001
71846519|NCT04237792|143207564|OTHER||Odds Ratio (OR)|0.11||||0.006|TWO_SIDED|95.0|0.02|0.59|||Mantel Haenszel|||||0.59|0.02|0.006
71846520|NCT04237792|143207564|OTHER||Odds Ratio (OR)|1.68||||0.597|TWO_SIDED|95.0|0.25|11.27|||Mantel Haenszel|||||11.27|0.25|0.597
71846521|NCT04237792|143207564|OTHER||Odds Ratio (OR)|0.54||||0.374|TWO_SIDED|95.0|0.14|2.07|||Mantel Haenszel|||||2.07|0.14|0.374
71846522|NCT04237792|143207564|OTHER||Odds Ratio (OR)|0.1||||0.001|TWO_SIDED|95.0|0.02|0.44|||Mantel Haenszel|||||0.44|0.02|0.001
71846523|NCT04237792|143207564|OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.81|||Mantel Haenszel|||||0.81|0.13|0.015
71846524|NCT04237792|143207564|OTHER||Odds Ratio (OR)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.87|||Mantel Haenszel|||||0.87|0.10|0.024
71846525|NCT04237792|143207565|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71846526|NCT04237792|143207565|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71846527|NCT04237792|143207565|OTHER|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
71846528|NCT04237792|143207565|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
71846529|NCT04237792|143207565|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71846530|NCT04237792|143207565|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71846531|NCT04237792|143207565|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71846532|NCT04237792|143207565|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71846533|NCT04237792|143207565|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71846534|NCT04237792|143207566|OTHER|||||||0.016|||||||Log Rank|||||||0.016
71846535|NCT04237792|143207566|OTHER|||||||0.005|||||||Log Rank|||||||0.005
71846536|NCT04237792|143207566|OTHER|||||||0.368|||||||Log Rank|||||||0.368
71846537|NCT04237792|143207566|OTHER|||||||0.358|||||||Log Rank|||||||0.358
71846538|NCT04237792|143207566|OTHER|||||||0|||||||Log Rank|||||||0.000
71846539|NCT04237792|143207566|OTHER|||||||0.001|||||||Log Rank|||||||0.001
71846540|NCT04237792|143207566|OTHER|||||||0.02|||||||Log Rank|||||||0.020
71846541|NCT04237792|143207566|OTHER|||||||0|||||||Log Rank|||||||0.000
71846542|NCT04237792|143207566|OTHER|||||||0.005|||||||Log Rank|||||||0.005
71846543|NCT04237792|143207567|OTHER|||||||0.884|||||||Log Rank|||||||0.884
71846544|NCT04237792|143207567|OTHER|||||||0.662|||||||Log Rank|||||||0.662
71846545|NCT04237792|143207567|OTHER|||||||0.236|||||||Log Rank|||||||0.236
71846546|NCT04237792|143207567|OTHER|||||||0.733|||||||Log Rank|||||||0.733
71846547|NCT04237792|143207567|OTHER|||||||0.128|||||||Log Rank|||||||0.128
71846548|NCT04237792|143207567|OTHER|||||||0.165|||||||Log Rank|||||||0.165
71846549|NCT04237792|143207567|OTHER|||||||0.752|||||||Log Rank|||||||0.752
71846550|NCT04237792|143207567|OTHER|||||||0.139|||||||Log Rank|||||||0.139
71846551|NCT04237792|143207567|OTHER|||||||0.051|||||||Log Rank|||||||0.051
71846552|NCT04237792|143207569|OTHER|||||||0.124|||||||ANOVA|||||||0.124
71846553|NCT04237792|143207569|OTHER|||||||0.186|||||||ANOVA|||||||0.186
71846554|NCT04237792|143207569|OTHER|||||||0.47|||||||ANOVA|||||||0.470
71846555|NCT04237792|143207569|OTHER|||||||0.845|||||||ANOVA|||||||0.845
71846556|NCT04237792|143207569|OTHER|||||||0.621|||||||ANOVA|||||||0.621
71846557|NCT04237792|143207569|OTHER|||||||0.747|||||||ANOVA|||||||0.747
71846558|NCT04237792|143207569|OTHER|||||||0.218|||||||ANOVA|||||||0.218
71846559|NCT04237792|143207569|OTHER|||||||0.181|||||||ANOVA|||||||0.181
71846560|NCT04237792|143207569|OTHER|||||||0.984|||||||ANOVA|||||||0.984
71846561|NCT04237792|143207570|OTHER|||||||0.048|||||||ANOVA|||||||0.048
71846562|NCT04237792|143207570|OTHER|||||||0.106|||||||ANOVA|||||||0.106
71846563|NCT04237792|143207570|OTHER|||||||0.196|||||||ANOVA|||||||0.196
71846564|NCT04237792|143207570|OTHER|||||||0.94|||||||ANOVA|||||||0.940
71846565|NCT04237792|143207570|OTHER|||||||0.824|||||||ANOVA|||||||0.824
71846566|NCT04237792|143207570|OTHER|||||||0.678|||||||ANOVA|||||||0.678
71846567|NCT04237792|143207570|OTHER|||||||0.129|||||||ANOVA|||||||0.129
71846568|NCT04237792|143207570|OTHER|||||||0.16|||||||ANOVA|||||||0.160
71846569|NCT04237792|143207570|OTHER|||||||0.872|||||||ANOVA|||||||0.872
71846570|NCT00087022|143207628|SUPERIORITY|||||||0.737|||||||Log Rank|||||||0.737
71846571|NCT00087022|143207629|SUPERIORITY|||||||1.012|||||||Log Rank|||||||1.012
71846572|NCT00087022|143207632|SUPERIORITY|||||||0.022|||||||Log Rank|||||||0.022
71846573|NCT02233998|143207651|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0162|<|0.001|TWO_SIDED|95.0|-0.266|-0.202||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.202|-0.266|<0.001
71846574|NCT02233998|143207651|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.197|STANDARD_ERROR_OF_MEAN|0.0161|<|0.001|TWO_SIDED|95.0|-0.228|-0.165||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.165|-0.228|<0.001
71846575|NCT02233998|143207652|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.469|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.526|-0.413||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.413|-0.526|<0.001
71846576|NCT02233998|143207652|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.379|STANDARD_ERROR_OF_MEAN|0.0286|<|0.001|TWO_SIDED|95.0|-0.435|-0.322||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.322|-0.435|<0.001
71846577|NCT02233998|143207653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.006|<|0.001|TWO_SIDED|95.0|-0.042|-0.019||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.019|-0.042|<0.001
71846578|NCT02233998|143207653|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.026|STANDARD_ERROR_OF_MEAN|0.0059|<|0.001|TWO_SIDED|95.0|-0.038|-0.014||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.014|-0.038|<0.001
71846579|NCT02233998|143207654|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.24|||<|0.001|TWO_SIDED|95.0|20.75|25.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||25.85|20.75|<0.001
71678541|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.11||||0.75|TWO_SIDED|95.0|0.58|2.13|||Regression, Logistic|||||2.13|0.58|0.75
71846580|NCT02233998|143207654|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.444|||<|0.001|TWO_SIDED|95.0|17.09|22.22||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||22.22|17.09|<0.001
71846581|NCT02233998|143207655|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
71846582|NCT02233998|143207655|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
71846583|NCT02233998|143207656|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|2.05|||<|0.001|TWO_SIDED|95.0|1.3|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|1.30|<0.001
71846584|NCT02233998|143207656|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.19|||<|0.001|TWO_SIDED|95.0|0.93|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.06|0.93|<0.001
71846585|NCT02233998|143207657|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|1.316||||0.016|TWO_SIDED|95.0|0.0|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||2.78|0.00|0.016
71846586|NCT02233998|143207657|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|0.926||||0.197|TWO_SIDED|95.0|-0.16|1.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||1.85|-0.16|0.197
71846587|NCT02233998|143207658|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|23.214|||<|0.001|TWO_SIDED|95.0|18.21|28.77||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||28.77|18.21|<0.001
71846588|NCT02233998|143207658|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|18.59|||<|0.001|TWO_SIDED|95.0|13.69|23.81||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||23.81|13.69|<0.001
71846589|NCT02233998|143207659|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|19.048|||<|0.001|TWO_SIDED|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||21.73|15.94|<0.001
71846590|NCT02233998|143207659|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate of difference|15.939|||<|0.001|TWO_SIDED|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.||18.67|12.50|<0.001
71846591|NCT01957163|143207660|SUPERIORITY_OR_OTHER||Least squared mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.093|0.154|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.154|0.093|< 0.001
71846592|NCT01957163|143207660|SUPERIORITY_OR_OTHER||Least squared mean difference|0.128|||<|0.001|TWO_SIDED|95.0|0.098|0.159|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.159|0.098|<0.001
71846593|NCT01957163|143207661|SUPERIORITY_OR_OTHER||Least squared mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.118|0.187|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.187|0.118|<0.001
71678542|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.15||||0.72|TWO_SIDED|95.0|0.53|2.49|||Regression, Logistic|||||2.49|0.53|0.72
71678543|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.74|TWO_SIDED|95.0|0.58|2.15|||Regression, Logistic|||||2.15|0.58|0.74
71678544|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.39||||0.34|TWO_SIDED|95.0|0.71|2.71|||Regression, Logistic|||||2.71|0.71|0.34
71846594|NCT01957163|143207661|SUPERIORITY_OR_OTHER||Least squared mean difference|0.14|||<|0.001|TWO_SIDED|95.0|0.106|0.175|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) - based repeated measure approach (MMRM)||||0.175|0.106|<0.001
71678545|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.19|TWO_SIDED|95.0|0.8|3.07|||Regression, Logistic|||||3.07|0.80|0.19
71678546|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.45||||0.012|TWO_SIDED|95.0|1.22|4.94|||Regression, Logistic|||||4.94|1.22|0.012
71814809|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.46|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.30|1.46|<0.001
71814810|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|3.24|||<|0.001|TWO_SIDED|95.0|2.3|4.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.19|2.30|<0.001
71814811|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|1.08||||0.006|TWO_SIDED|95.0|0.31|1.85||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.85|0.31|0.006
71846595|NCT03697603|143207669|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0312|TWO_SIDED|95.0|-2.7|-0.1|||MMRM|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||-0.1|-2.7|0.0312
71846596|NCT03697603|143207669|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0089|TWO_SIDED|95.0|-3.0|-0.4|||MMRM|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||-0.4|-3.0|0.0089
71846597|NCT03697603|143207670|OTHER||Diff|5.5||||0.1964|TWO_SIDED|95.0|-2.8|13.8|||Chi-squared|||Statistical analysis to compare brexpiprazole 2 mg/day and placebo was performed at Week 6.||13.8|-2.8|0.1964
71846598|NCT03697603|143207670|OTHER||Diff|5.5||||0.1969|TWO_SIDED|95.0|-2.8|13.7|||Chi-squared|||Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 6.||13.7|-2.8|0.1969
71846599|NCT02686658|143207671|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare the treatment groups.|Least Squares Mean Difference|0.11||||0.0072|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0072
71846600|NCT02686658|143207671|OTHER|Model for repeated measures (MRM) and square root transformation was used to compare treatment groups.|Least Squares Mean Difference|0.124||||0.0051|TWO_SIDED|95.0|||||Model for repeated measures (MRM)|||Difference in least squares means between groups calculated as (Sham) minus (Zimura).||||0.0051
71846601|NCT02686658|143207672|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|1.39||||0.3464|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.3464
71846602|NCT02686658|143207672|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-0.28||||0.883|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8830
71846603|NCT02686658|143207673|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|0.38||||0.8405|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.8405
71846604|NCT02686658|143207673|OTHER|Model for repeated measures (MRM) was used to compare the treatment groups.|Least Squares Mean Difference|-1.44||||0.5017|TWO_SIDED||||||Model for repeated measures (MRM)|||Difference in least squares mean between groups calculated as (Zimura) minus (Sham).||||0.5017
71846605|NCT02222493|143207708|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|95.0|-9.92|5.11||||||Score statistic method||5.11|-9.92|
71846606|NCT02222493|143207708|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence test|Proportion Difference|-2.39|||||TWO_SIDED|90.0|-8.75|4.02||||||Score statistic method||4.02|-8.75|
71846607|NCT03924869|143207750|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2932|TWO_SIDED|95.0|0.69|1.24||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|||"Hazard ratio and 95% confidence intervals (CIs) were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||1.24|0.69|0.29320
71846608|NCT03924869|143207751|OTHER||Hazard Ratio (HR)|1.33||||0.93971|TWO_SIDED|95.0|0.93|1.9||1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.|Log Rank|Per protocol, since the EFS null hypothesis was not rejected, the OS hypothesis was not formally tested and the p-value should be considered nominal.||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.90|0.93|0.93971
71846609|NCT03924869|143207752|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.74|1.42||Per protocol, there was no hypothesis pre-specified for TDDM to be formally tested.||||"Hazard ratio and 95% CIs were based on Cox regression model with Efron's method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery (medically inoperable versus refused surgery)."||1.42|0.74|
71678547|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.59||||0.25|TWO_SIDED|95.0|0.72|3.47|||Regression, Logistic|||||3.47|0.72|0.25
71678548|NCT01340027|142875319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.67||||0.21|TWO_SIDED|95.0|0.74|3.75|||Regression, Logistic|||||3.75|0.74|0.21
71846610|NCT03924869|143207755|OTHER||Mean Difference (Final Values)|-1.21||||0.5187|TWO_SIDED|95.0|-4.9|2.48|||cLDA model|||"Stats:~LS Mean change and 95% CIs were based on a constrained longitudinal data analysis (cLDA) model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery)."||2.48|-4.90|0.5187
71846611|NCT03924869|143207756|OTHER||Mean Difference (Final Values)|-4.34||||0.0906|TWO_SIDED|95.0|-9.38|0.69|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||0.69|-9.38|0.0906
71846612|NCT03924869|143207757|OTHER||Mean Difference (Final Values)|1.24||||0.5482|TWO_SIDED|95.0|-2.83|5.31|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||5.31|-2.83|0.5482
71846613|NCT03924869|143207758|OTHER||Mean Difference (Final Values)|-0.99||||0.7253|TWO_SIDED|95.0|-6.5|4.53|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||4.53|-6.50|0.7253
71846614|NCT03924869|143207759|OTHER||Mean Difference (Final Values)|-0.21||||0.9055|TWO_SIDED|95.0|-3.7|3.28|||cLDA model|||LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).||3.28|-3.70|0.9055
71846615|NCT02542943|143207760|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.13||||0.435|TWO_SIDED|95.0|-0.4|0.134||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.134|-0.400|0.4350
71846616|NCT02542943|143207760|SUPERIORITY_OR_OTHER||LS mean difference|0.07||||0.7605|TWO_SIDED|95.0|-0.192|0.34||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett's multiplicity adjustment is applied.|||0.340|-0.192|0.7605
71846617|NCT02542943|143207761|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.0873|TWO_SIDED|95.0|-0.445|0.031||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.031|-0.445|0.0873
71846618|NCT02542943|143207762|SUPERIORITY_OR_OTHER||LS mean difference|-0.07||||0.4921|TWO_SIDED|95.0|-0.27|0.13||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.130|-0.270|0.4921
71846619|NCT02542943|143207762|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.8728|TWO_SIDED|95.0|-0.183|0.216||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.216|-0.183|0.8728
71846620|NCT02542943|143207762|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.4003|TWO_SIDED|95.0|-0.287|0.115||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.115|-0.287|0.4003
71846621|NCT02542943|143207763|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8106|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8106
71846622|NCT02542943|143207763|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1656|TWO_SIDED|95.0|-5.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.1656
71846623|NCT02542943|143207763|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1419|TWO_SIDED|95.0|0.0|5.0|||Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.1419
71898475|NCT00637273|143320234|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.035||0.0062|TWO_SIDED|95.0|0.82|0.96||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (\<9.0% or \>=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.||0.96|0.82|0.0062
71898476|NCT02795767|143320323|OTHER||ABR Ratio|0.01|||||TWO_SIDED|95.0|0.006|0.023|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.023|0.006|
71898477|NCT02795767|143320324|OTHER||ABR Ratio|0.1|||||TWO_SIDED|95.0|0.051|0.21|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.|||0.210|0.051|
71898478|NCT02553915|143320353|OTHER|Comparisons were made for each biomarker within each arm pre and post 12 weeks of treatment.|||||<|0.1|||||||Kruskal-Wallis|||To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma IL-6 levels or in mitogen-stimulated PBMC TNF-α expression and secretion, when compared with placebo. \[Time Frame: 12 weeks\]. Comparisons were made within each arm pre and post 12 weeks of treatment.||||<0.10
71678549|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.376||0.63|TWO_SIDED|95.0|-0.56|0.92|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."||0.92|-0.56|0.63
71678550|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.31||0.56|TWO_SIDED|95.0|-0.43|0.79|||ANCOVA|||||0.79|-0.43|0.56
71678551|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.14|TWO_SIDED|95.0|-0.15|1.06|||ANCOVA|||||1.06|-0.15|0.14
71678552|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.313||0.027|TWO_SIDED|95.0|0.08|1.3|||ANCOVA|||||1.30|0.08|0.027
71814812|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.16|||<|0.001|TWO_SIDED|95.0|1.22|3.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.10|1.22|<0.001
71814813|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||<|0.001|TWO_SIDED|95.0|1.51|3.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.43|1.51|<0.001
71814814|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.7||||0.08|TWO_SIDED|95.0|-0.09|1.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.49|-0.09|0.080
71814815|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|1.77|||<|0.001|TWO_SIDED|95.0|0.81|2.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.73|0.81|<0.001
71814816|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|2.39|||<|0.001|TWO_SIDED|95.0|1.41|3.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.37|1.41|<0.001
71814817|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|0.85||||0.037|TWO_SIDED|95.0|0.05|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.65|0.05|0.037
71814818|NCT01216163|143131366|SUPERIORITY_OR_OTHER||LS mean difference|1.54||||0.002|TWO_SIDED|95.0|0.57|2.52||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.52|0.57|0.002
71898479|NCT02553915|143320354|SUPERIORITY||||||<|0.1|||||||ANOVA|||"To evaluate:~1. whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and~2. whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression mediate changes observed in ratings of depression.~\[Time Frame: 12 weeks\]"||||<0.1
71898480|NCT02553915|143320355|OTHER||||||<|0.01|||||||Kruskal-Wallis|||Change in IDS-C30 scores were compared pre and post 12 weeks of treatment with each intervention, within each arm.||||<0.01
71678553|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.308||0.13|TWO_SIDED|95.0|-0.14|1.07|||ANCOVA|||||1.07|-0.14|0.13
71678554|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.371||0.049|TWO_SIDED|95.0|0.0|1.46|||ANCOVA|||||1.46|0.00|0.049
71678555|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.368||0.011|TWO_SIDED|95.0|0.22|1.66|||ANCOVA|||||1.66|0.22|0.011
71814819|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|2.38|||<|0.001|TWO_SIDED|95.0|1.88|2.88||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.88|1.88|<0.001
71898481|NCT02553915|143320356|OTHER|Exploratory.|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in mitogen-stimulated PBMC IL-6. \[Time Frame: 12 weeks\] Comparisons were made between pre and post treatment levels in each of the 4 treatment arms.||||<0.1
71898482|NCT02553915|143320357|OTHER|Exploratory|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes. \[Time Frame: 12 weeks\] (We evaluated gene expression of IL-6 and TNF-α.)||||<0.1
71678556|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.428||0.7|TWO_SIDED|95.0|-0.67|1.01|||ANCOVA|||||1.01|-0.67|0.70
71898483|NCT03078608|143320392|SUPERIORITY||F statistic|0.0||||1|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||1.00
71898484|NCT03078608|143320393|SUPERIORITY||F statistic|2.58||||0.11|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.11
71898485|NCT03078608|143320394|SUPERIORITY||F statistic|0.07||||0.79|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.79
71898486|NCT03078608|143320395|SUPERIORITY||F statistic|1.17||||0.29|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.29
71898487|NCT03078608|143320396|SUPERIORITY||F statistic|0.18||||0.67|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.67
71898488|NCT03078608|143320397|SUPERIORITY||F statistic|1.41||||0.24|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.24
71898489|NCT03078608|143320398|SUPERIORITY||F statistic|1.36||||0.25|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.25
71898490|NCT03078608|143320399|SUPERIORITY||F statistic|0.53||||0.47|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.47
71898491|NCT03078608|143320400|SUPERIORITY||F statistic|1.54||||0.23|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.23
71898492|NCT03078608|143320401|SUPERIORITY||F statistic|0.8||||0.39|TWO_SIDED||||||ANOVA|Repeated measures ANOVA||||||0.39
71898493|NCT00784784|143320455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.23||||0.25|TWO_SIDED|95.0|0.01|4.8|||Fisher Exact|||That in a year with mismatch between influenza vaccine antigen and infecting H3N2 strain, seasonal (10-13 weeks) antiviral prophylaxis in adults will provide better protection from symptomatic influenza infection than trivalent inactivated split virus influenza vaccine.||4.8|0.01|0.25
71898494|NCT01905397|143320456|SUPERIORITY||Difference in proportions|0.05||||0.27|ONE_SIDED||||||t-test, 1 sided|||||||0.27
71898495|NCT00844428|143320459|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|80.0|||||TWO_SIDED|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS."||94|56|
71898496|NCT00844428|143320460|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
71898497|NCT00844428|143320461|SUPERIORITY_OR_OTHER||Percent of complete TMA response|25.0|||||TWO_SIDED|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||49|9|
71898498|NCT00844428|143320462|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
71898499|NCT00844428|143320463|SUPERIORITY_OR_OTHER||LS mean change from baseline|6.75||||0.5423|TWO_SIDED|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||29.23|-15.73|0.5423
71898500|NCT00844428|143320464|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71898501|NCT00844428|143320465|SUPERIORITY_OR_OTHER||Percent of TMA event-free responders|95.0|||||TWO_SIDED|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||100|75|
71898502|NCT00844428|143320466|SUPERIORITY_OR_OTHER||Percent of hematologic normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||99|68|
71898503|NCT00844428|143320467|SUPERIORITY_OR_OTHER||Percent of complete TMA response|55.0|||||TWO_SIDED|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||77|32|
71898504|NCT00844428|143320468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||||<0.0001
71898505|NCT00844428|143320469|SUPERIORITY_OR_OTHER||LS mean change from baseline|-3.68||||0.7307|TWO_SIDED|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years with aHUS.||17.79|-25.15|0.7307
71898506|NCT00844428|143320470|SUPERIORITY_OR_OTHER||Percent of platelet count normalization|90.0|||||TWO_SIDED|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients \<18 years||99|68|
71898507|NCT02099799|143320472|SUPERIORITY||Mean Difference (Final Values)|-12.0||||0.189|TWO_SIDED||||||Mixed Models Analysis|||||||0.189
71898508|NCT02099799|143320473|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.572|TWO_SIDED||||||Mixed Models Analysis|||||||0.572
71898509|NCT02099799|143320474|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.799|TWO_SIDED||||||Mixed Models Analysis|||||||0.799
71898510|NCT02099799|143320475|SUPERIORITY||Mean Difference (Final Values)|1312.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71898511|NCT02099799|143320476|SUPERIORITY|||||||0.2265|||||||t-test, 2 sided|||||||0.2265
71898512|NCT02099799|143320477|SUPERIORITY|||||||0.8897|||||||t-test, 2 sided|||||||0.8897
71898513|NCT00772967|143320479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.611||||0.089||90.0|-1.36|0.14||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.14|-1.36|0.089
71898514|NCT00772967|143320479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.804||||0.043||90.0|-1.57|-0.04||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.04|-1.57|0.043
71898515|NCT00772967|143320480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.518||||0.048||90.0|-1.03|-0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.01|-1.03|0.048
71898516|NCT00772967|143320480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.001||90.0|-1.54|-0.53||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.53|-1.54|0.001
71898517|NCT00772967|143320481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.658||||0.052||90.0|-1.32|0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||0.01|-1.32|0.052
71898518|NCT00772967|143320481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15||||0.003||90.0|-1.81|-0.49||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.49|-1.81|0.003
71898519|NCT00772967|143320482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.875||||0.019||90.0|-1.56|-0.19||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.19|-1.56|0.019
71898520|NCT00772967|143320482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.007||90.0|-1.77|-0.37||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk||||-0.37|-1.77|0.007
71898521|NCT01041573|143320485|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641|||||||Fisher Exact|||||||0.641
71898522|NCT01041573|143320485|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71898523|NCT04172831|143320492|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.1|-0.7|0.010
71898524|NCT04172831|143320493|SUPERIORITY||Odds Ratio (OR)|1.44||||0.058|TWO_SIDED|95.0|0.99|2.1|||Regression, Logistic|||||2.10|0.99|0.058
71898525|NCT04172831|143320494|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.6||0.007|TWO_SIDED|95.0|-7.5|-1.2|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.2|-7.5|0.007
71898526|NCT04172831|143320495|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.69||0.009|TWO_SIDED|95.0|-7.7|-1.1|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.1|-7.7|0.009
71898527|NCT04172831|143320496|SUPERIORITY||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-4.5|-1.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-1.3|-4.5|<0.001
71898528|NCT04172831|143320497|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.76||0.018|TWO_SIDED|95.0|-3.3|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-3.3|0.018
71898529|NCT04172831|143320498|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Model Repeated Measures||Treatment Difference = TNX-102 - Placebo|||-0.3|-0.9|<0.001
71898530|NCT00492401|143320503|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Expression levels of miR-29b in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.02
71898531|NCT00492401|143320503|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Expression levels of DNMT3a in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests||||.06
71898532|NCT01000064|143320560|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.053
71898533|NCT01000064|143320561|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.052
71898534|NCT01000064|143320562|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71898535|NCT01000064|143320563|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71898536|NCT01000064|143320564|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71898537|NCT01000064|143320565|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.040
71898538|NCT01000064|143320566|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71898539|NCT00798967|143320577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Cochran-Mantel-Haenszel (CMH) test adjusted for the randomization stratification variable (\<= 6 or \> 6 L/week of PN at baseline)|Cochran-Mantel-Haenszel|||||||0.002
71898540|NCT00798967|143320578|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|||Last Dosing Visit||||< 0.001
71898541|NCT03141307|143320580|EQUIVALENCE|95% margin|||||<|0.001||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.001
71898542|NCT03141307|143320581|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
71898543|NCT03141307|143320582|EQUIVALENCE|95% margin|||||=|0.502||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.502
71898544|NCT03141307|143320583|EQUIVALENCE|95% margin|||||=|0.071||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||=.071
71898545|NCT03141307|143320584|EQUIVALENCE|95% margin|||||=|0.124||||||a prior threshold for statistical significance set for p \< .05.|t-test, 2 sided|||||||=.124
71898546|NCT03141307|143320585|EQUIVALENCE|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p \< .05|t-test, 2 sided|||||||<.05
71898547|NCT02160977|143320599|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71898548|NCT02160977|143320600|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71898549|NCT02160977|143320601|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71898550|NCT01614769|143320646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41|||||TWO_SIDED|90.0|-22.98|51.8||||||||51.80|-22.98|
71898551|NCT01614769|143320646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.33|||||TWO_SIDED|90.0|-2.08|72.74||||||||72.74|-2.08|
71898552|NCT01614769|143320647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.21|0.0||||||||0.00|-0.21|
71898553|NCT01614769|143320647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.24|-0.03||||||||-0.03|-0.24|
71898554|NCT01614769|143320648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03|||||TWO_SIDED|90.0|-11.12|1.05||||||||1.05|-11.12|
71898555|NCT01614769|143320648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||||TWO_SIDED|90.0|-13.3|-1.24||||||||-1.24|-13.30|
71898556|NCT04760314|143320654|SUPERIORITY||Risk Difference (RD)|22.6|||<|0.001|TWO_SIDED|95.0|11.6|33.6|||Cochran-Mantel-Haenszel|||||33.6|11.6|<0.001
71898557|NCT04760314|143320654|SUPERIORITY||Risk Difference (RD)|27.3|||<|0.001|TWO_SIDED|95.0|17.5|37.0|||Cochran-Mantel-Haenszel|||||37.0|17.5|<0.001
71898558|NCT04760314|143320655|SUPERIORITY||Risk Difference (RD)|33.2|||<|0.001|TWO_SIDED|95.0|20.6|45.8|||Cochran-Mantel-Haenszel|||||45.8|20.6|<0.001
71898559|NCT04760314|143320655|SUPERIORITY||Risk Difference (RD)|37.6|||<|0.001|TWO_SIDED|95.0|26.2|49.0|||Cochran-Mantel-Haenszel|||||49.0|26.2|<0.001
71898560|NCT04760314|143320656|SUPERIORITY||LS Mean Difference|-34.5|||<|0.001|TWO_SIDED|95.0|-44.1|-24.9|||ANCOVA|||||-24.9|-44.1|<0.001
71814820|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.007|TWO_SIDED|95.0|0.15|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||0.97|0.15|0.007
71814821|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|1.82|||<|0.001|TWO_SIDED|95.0|1.32|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.32|1.32|<0.001
71814822|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|3.67|||<|0.001|TWO_SIDED|95.0|2.85|4.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.49|2.85|<0.001
71814823|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|0.98||||0.004|TWO_SIDED|95.0|0.31|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.66|0.31|0.004
71814824|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|2.69|||<|0.001|TWO_SIDED|95.0|1.87|3.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.51|1.87|<0.001
71814825|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|6.8|||<|0.001|TWO_SIDED|95.0|4.96|8.64||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||8.64|4.96|<0.001
71814826|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|2.09||||0.007|TWO_SIDED|95.0|0.59|3.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.59|0.59|0.007
71814827|NCT01216163|143131367|SUPERIORITY_OR_OTHER||LS mean difference|4.71|||<|0.001|TWO_SIDED|95.0|2.87|6.54||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.54|2.87|<0.001
71814828|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|3.81|||<|0.001|TWO_SIDED|95.0|3.05|4.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.57|3.05|<0.001
71814829|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|0.76||||0.016|TWO_SIDED|95.0|0.14|1.38||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||1.38|0.14|0.016
71898561|NCT04760314|143320656|SUPERIORITY||LS Mean Difference|-38.99|||<|0.001|TWO_SIDED|95.0|-47.7|-30.3|||ANCOVA|||||-30.3|-47.7|<0.001
71898562|NCT04760314|143320657|SUPERIORITY||Risk Difference (RD)|18.4||||0.003|TWO_SIDED|95.0|6.8|29.9|||Cochran-Mantel-Haenszel|||||29.9|6.8|0.003
71898563|NCT04760314|143320657|SUPERIORITY||Risk Difference (RD)|24.2|||<|0.001|TWO_SIDED|95.0|13.9|34.5|||Cochran-Mantel-Haenszel|||||34.5|13.9|<0.001
71814830|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|3.04|||<|0.001|TWO_SIDED|95.0|2.29|3.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||3.80|2.29|<0.001
71814831|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|5.9|||<|0.001|TWO_SIDED|95.0|4.66|7.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.15|4.66|<0.001
71898564|NCT04760314|143320658|SUPERIORITY||Risk Difference (RD)|1.2||||0.404|TWO_SIDED|95.0|-1.2|3.6|||Cochran-Mantel-Haenszel|||||3.6|-1.2|0.404
71898565|NCT04760314|143320659|SUPERIORITY||Risk Difference (RD)|1.8||||0.294|TWO_SIDED|95.0|-1.6|5.1|||Cochran-Mantel-Haenszel|||||5.1|-1.6|0.294
71898566|NCT04760314|143320659|SUPERIORITY||Risk Difference (RD)|3.7||||0.138|TWO_SIDED|95.0|-0.5|7.8|||Cochran-Mantel-Haenszel|||||7.8|-0.5|0.138
71898567|NCT04760314|143320660|SUPERIORITY||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.8|16.5|||Cochran-Mantel-Haenszel|||||16.5|1.8|0.013
71678557|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.423||0.084|TWO_SIDED|95.0|-0.1|1.56|||ANCOVA|||||1.56|-0.10|0.084
71678558|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.66|STANDARD_ERROR_OF_MEAN|0.425||0.12|TWO_SIDED|95.0|-0.18|1.49|||ANCOVA|||||1.49|-0.18|0.12
71678559|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.369||0.36|TWO_SIDED|95.0|-0.39|1.06|||ANCOVA|||||1.06|-0.39|0.36
71678560|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.428||0.23|TWO_SIDED|95.0|-0.32|1.36|||ANCOVA|||||1.36|-0.32|0.23
71814832|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|1.35||||0.01|TWO_SIDED|95.0|0.33|2.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.37|0.33|0.010
71814833|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|4.56|||<|0.001|TWO_SIDED|95.0|3.31|5.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.80|3.31|<0.001
71814834|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|10.88|||<|0.001|TWO_SIDED|95.0|8.05|13.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||13.70|8.05|<0.001
71814835|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|2.87||||0.015|TWO_SIDED|95.0|0.57|5.18||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||5.18|0.57|0.015
71814836|NCT01216163|143131368|SUPERIORITY_OR_OTHER||LS mean difference|8.0|||<|0.001|TWO_SIDED|95.0|5.18|10.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||10.83|5.18|<0.001
71814837|NCT01216163|143131369|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||<|0.001|TWO_SIDED|95.0|4.96|7.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||7.43|4.96|<0.001
71846624|NCT02542943|143207764|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5631|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.5631
71678561|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.371||0.16|TWO_SIDED|95.0|-0.21|1.25|||ANCOVA|||||1.25|-0.21|0.16
71678562|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.371||0.032|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.032
71678563|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.373||0.006|TWO_SIDED|95.0|0.3|1.76|||ANCOVA|||||1.76|0.30|0.006
71678564|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.369||0.031|TWO_SIDED|95.0|0.07|1.52|||ANCOVA|||||1.52|0.07|0.031
71898568|NCT04760314|143320660|SUPERIORITY||Risk Difference (RD)|16.2||||0.001|TWO_SIDED|95.0|8.1|24.3|||Cochran-Mantel-Haenszel|||||24.3|8.1|0.001
71898569|NCT04760314|143320661|SUPERIORITY||Risk Difference (RD)|20.6||||0.001|TWO_SIDED|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|||||32.4|8.7|0.001
71898570|NCT04760314|143320661|SUPERIORITY||Risk Difference (RD)|29.2|||<|0.001|TWO_SIDED|95.0|17.9|40.4|||Cochran-Mantel-Haenszel|||||40.4|17.9|<0.001
71898571|NCT01290484|143320662|SUPERIORITY_OR_OTHER||Mean percentage volume change|-3.47||||||||||||||||||
71898572|NCT00960440|143320663|SUPERIORITY_OR_OTHER||Percentage Difference|23.69|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|12.45|34.92||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||34.92|12.45|<0.0001
71898573|NCT00960440|143320663|SUPERIORITY_OR_OTHER||Percentage Difference|17.23|STANDARD_ERROR_OF_MEAN|5.7||0.0024|TWO_SIDED|95.0|6.06|28.41||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||28.41|6.06|0.0024
71898574|NCT00960440|143320664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.38|-0.17||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.17|-0.38|<0.0001
71678565|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.423||0.012|TWO_SIDED|95.0|0.24|1.9|||ANCOVA|||||1.90|0.24|0.012
71678566|NCT01340027|142875327|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.421||0.002|TWO_SIDED|95.0|0.45|2.1|||ANCOVA|||||2.10|0.45|0.002
71846625|NCT02542943|143207764|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.8423|TWO_SIDED|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|0.000|0.8423
71846626|NCT02542943|143207764|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.439|TWO_SIDED|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|0.000|0.4390
71898575|NCT00960440|143320664|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.36|-0.15||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.||-0.15|-0.36|<0.0001
71898576|NCT00960440|143320665|SUPERIORITY_OR_OTHER||Percentage Difference|9.53|STANDARD_ERROR_OF_MEAN|3.05||0.0017|TWO_SIDED|95.0|3.54|15.51||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||15.51|3.54|0.0017
71898577|NCT00960440|143320665|SUPERIORITY_OR_OTHER||Percentage Difference|5.05|STANDARD_ERROR_OF_MEAN|2.57||0.0496|TWO_SIDED|95.0|0.0|10.1||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||10.10|0.00|0.0496
71898578|NCT02345161|143320719|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.171|STANDARD_ERROR_OF_MEAN|0.0118|<|0.001|TWO_SIDED|95.0|0.148|0.194|||Mixed Model Repeated Measures|||||0.194|0.148|<0.001
71898579|NCT02345161|143320720|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|0.179|STANDARD_ERROR_OF_MEAN|0.0242|<|0.001|TWO_SIDED|95.0|0.131|0.226|||Mixed Model Repeated Measures|||||0.226|0.131|<0.001
71898580|NCT02345161|143320721|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-3.5|-1.0|||Mixed Model Repeated Measures|||||-1.0|-3.5|<0.001
71898581|NCT02345161|143320722|SUPERIORITY_OR_OTHER||Adjusted LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|1.44||0.065|TWO_SIDED|95.0|-5.5|0.2|||Mixed Model Repeated Measures|||||0.2|-5.5|0.065
71898582|NCT02345161|143320723|SUPERIORITY_OR_OTHER||LS Mean difference|0.57|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|0.3|0.84|||Mixed effect repeated measures model|||||0.84|0.30|<0.001
71898583|NCT02345161|143320724|SUPERIORITY_OR_OTHER||LS Mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.317||0.279|TWO_SIDED|95.0|-0.28|0.97|||Mixed effect repeated measures model|||||0.97|-0.28|0.279
71898584|NCT02345161|143320725|SUPERIORITY_OR_OTHER||LS Mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.817|TWO_SIDED|95.0|-0.9|1.1|||ANCOVA|||||1.1|-0.9|0.817
71898585|NCT02345161|143320726|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.767|TWO_SIDED|95.0|-2.1|1.6|||ANCOVA|||||1.6|-2.1|0.767
71898586|NCT02345161|143320727|SUPERIORITY_OR_OTHER||Rate ratio|0.65||||0.002|TWO_SIDED|95.0|0.49|0.86|||Generalized linear modeL|Generalized linear model assuming a negative binomial distribution||||0.86|0.49|0.002
71898587|NCT02345161|143320728|SUPERIORITY_OR_OTHER||Rate ratio|0.56||||0.006|TWO_SIDED|95.0|0.37|0.85|||Generalized Linear model|Generalized linear model assuming a negative binomial distribution||||0.85|0.37|0.006
71678567|NCT04687072|142875333|SUPERIORITY||Difference in percentage|-3.5||||0.5081|TWO_SIDED|95.0|-14.7|7.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% confidence interval (CI) (Klingenberg approach) were presented.|||7.0|-14.7|0.5081
71678568|NCT04687072|142875334|SUPERIORITY||Location shift|0.0||||0.4925|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.4925
71898588|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.25|-0.66|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||-0.66|-1.25|<0.001
71898589|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.183|<|0.001|TWO_SIDED|95.0|-1.59|-0.87|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.87|-1.59|<0.001
71898590|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.201|<|0.001|TWO_SIDED|95.0|-1.57|-0.78|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.78|-1.57|<0.001
71898591|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-1.33|STANDARD_ERROR_OF_MEAN|0.213|<|0.001|TWO_SIDED|95.0|-1.75|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.91|-1.75|<0.001
71898592|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.223|<|0.001|TWO_SIDED|95.0|-1.85|-0.97|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.97|-1.85|<0.001
71898593|NCT02345161|143320729|SUPERIORITY_OR_OTHER||Mixed Model Repeated Measures|-1.35|STANDARD_ERROR_OF_MEAN|0.224|<|0.001|TWO_SIDED|95.0|-1.79|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 21-24|||-0.91|-1.79|<0.001
71898594|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.67|-0.36|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 1-4|||-0.36|-0.67|<0.001
71678569|NCT04687072|142875335|SUPERIORITY||Difference in percentage|-0.5||||0.9314|TWO_SIDED|95.0|-11.7|10.0||The p-value was calculated using the Cochran-Mantel-Haenszel test used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentages and 95% CI (Klingenberg approach) were presented.|||10.0|-11.7|0.9314
71678570|NCT04687072|142875336|SUPERIORITY||Difference in percentage|-1.7||||0.7379|TWO_SIDED|95.0|-12.4|8.2||The Cochran-Mantel-Haenszel test p-value was used in the hierarchical testing procedure.|Cochran-Mantel-Haenszel||The adjusted difference in percentage and 95% CI (Klingenberg approach) are presented.|||8.2|-12.4|0.7379
71678571|NCT04687072|142875337|OTHER||Difference in percentage|4.2|||||TWO_SIDED|95.0|-9.3|16.8|||||||The 95% Agresti-Min CIs are presented.|16.8|-9.3|
71678572|NCT04687072|142875338|SUPERIORITY||Location shift|0.0||||0.726|TWO_SIDED|95.0|0.0|0.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||0.000|0.000|0.7260
71814838|NCT01216163|143131369|SUPERIORITY_OR_OTHER||LS mean difference|1.33||||0.01|TWO_SIDED|95.0|0.32|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||2.33|0.32|0.010
71898595|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.098|<|0.001|TWO_SIDED|95.0|-0.88|-0.5|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 5-8|||-0.50|-0.88|<0.001
71814839|NCT01216163|143131369|SUPERIORITY_OR_OTHER||LS mean difference|4.87|||<|0.001|TWO_SIDED|95.0|3.63|6.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||6.10|3.63|<0.001
71814840|NCT01216163|143131369|SUPERIORITY_OR_OTHER||LS mean difference|9.58|||<|0.001|TWO_SIDED|95.0|7.54|11.61||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||11.61|7.54|<0.001
71814841|NCT01216163|143131369|SUPERIORITY_OR_OTHER||LS mean difference|2.33||||0.006|TWO_SIDED|95.0|0.67|4.0||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||4.00|0.67|0.006
71814842|NCT01216163|143131369|SUPERIORITY_OR_OTHER||LS mean difference|7.24|||<|0.001|TWO_SIDED|95.0|5.21|9.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.||9.28|5.21|<0.001
71814843|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|21.42|||<|0.001|TWO_SIDED|95.0|12.99|29.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.||29.84|12.99|<0.001
71846627|NCT02542943|143207765|SUPERIORITY_OR_OTHER||LS mean difference|-0.15||||0.517|TWO_SIDED|95.0|-0.611|0.308||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.308|-0.611|0.5170
71898596|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.108|<|0.001|TWO_SIDED|95.0|-0.9|-0.48|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 9-12|||-0.48|-0.90|<0.001
71898597|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.115|<|0.001|TWO_SIDED|95.0|-0.97|-0.52|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 13-16|||-0.52|-0.97|<0.001
71898598|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.03|-0.56|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 17-20|||-0.56|-1.03|<0.001
71898599|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-1.01|-0.54|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 21-24|||-0.54|-1.01|<0.001
71898600|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.044|<|0.001|TWO_SIDED|95.0|-0.26|-0.09|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 1-4|||-0.09|-0.26|<0.001
71678573|NCT04687072|142875339|OTHER||Difference in percentage|2.5|||||TWO_SIDED|95.0|-9.6|13.0|||||The 95% Agresti-Min CIs are presented.|||13.0|-9.6|
71678574|NCT04687072|142875342|SUPERIORITY||Location shift|0.0||||0.2929|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.2929
71678575|NCT04687072|142875343|SUPERIORITY||Location shift|0.0||||0.1475|TWO_SIDED|95.0|0.0|1.0||The p-value was calculated using the stratified Mann-Whitney test.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|||1.000|0.000|0.1475
71678576|NCT04687072|142875344|SUPERIORITY||Location shift|0.0||||0.7677|TWO_SIDED|95.0|-2.0|2.0||The p-value was calculated using the stratified Mann-Whitney test used in the hierarchical testing procedure.|Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator of the treatment difference and 95% CI are presented.|WHO Classified Bleeding Event Grade ≥1||2.000|-2.000|0.7677
71678577|NCT04687072|142875345|OTHER||Difference in percentage|-1.2|||||TWO_SIDED|95.0|-11.8|7.3|||||The 95% Agresti-Min CIs are presented.|IWG Complete Response||7.3|-11.8|
71898601|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.053|<|0.001|TWO_SIDED|95.0|-0.31|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 5-8|||-0.10|-0.31|<0.001
71678578|NCT04687072|142875345|OTHER||Difference in percentage|8.5|||||TWO_SIDED|95.0|-4.6|20.2|||||The 95% Agresti-Min CIs are presented.|IWG Response||20.2|-4.6|
71814844|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|1.58||||0.799|TWO_SIDED|95.0|-10.54|13.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||13.70|-10.54|0.799
71678579|NCT04687072|142875345|OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-9.7|13.3|||||The 95% Agresti-Min CIs are presented.|Initial Response||13.3|-9.7|
71678580|NCT04687072|142875347|OTHER||Difference in percentage|-4.0|||||TWO_SIDED|95.0|-15.6|5.7|||||The 95% Agresti-Min CIs are presented.|||5.7|-15.6|
71678581|NCT00915876|142875357|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71814845|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|20.09||||0.001|TWO_SIDED|95.0|11.45|28.72||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||28.72|11.45|0.001
71814846|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|53.22|||<|0.001|TWO_SIDED|95.0|42.92|63.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||63.53|42.92|<0.001
71814847|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|-2.98||||0.695|TWO_SIDED|95.0|-17.67|11.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||11.70|-17.67|0.695
71814848|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|57.06|||<|0.001|TWO_SIDED|95.0|46.53|67.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||67.60|46.53|<0.001
71814849|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|70.58|||<|0.001|TWO_SIDED|95.0|60.28|80.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.88|60.28|<0.001
71814850|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|7.99||||0.261|TWO_SIDED|95.0|-5.85|21.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||21.84|-5.85|0.261
71814851|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|62.88|||<|0.001|TWO_SIDED|95.0|51.78|73.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||73.99|51.78|<0.001
71814852|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|66.24|||<|0.001|TWO_SIDED|95.0|53.77|78.71||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.71|53.77|<0.001
71814853|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|4.38||||0.522|TWO_SIDED|95.0|-8.89|17.64||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.64|-8.89|0.522
71814854|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|61.93|||<|0.001|TWO_SIDED|95.0|49.06|74.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.80|49.06|<0.001
71814855|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|66.35|||<|0.001|TWO_SIDED|95.0|53.61|79.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.09|53.61|<0.001
71814856|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|5.46||||0.415|TWO_SIDED|95.0|-7.53|18.44||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.44|-7.53|0.415
71814857|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|60.92|||<|0.001|TWO_SIDED|95.0|47.65|74.19||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.19|47.65|<0.001
71814858|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|65.32|||<|0.001|TWO_SIDED|95.0|52.18|78.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||78.46|52.18|<0.001
71814859|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|4.21||||0.519|TWO_SIDED|95.0|-8.39|16.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.81|-8.39|0.519
71814860|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814861|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71814862|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814863|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814864|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71814865|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814866|NCT01216163|143131370|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814867|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|26.4|||<|0.001|TWO_SIDED|95.0|15.87|36.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.93|15.87|<0.001
71814868|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|3.53||||0.602|TWO_SIDED|95.0|-9.85|16.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.91|-9.85|0.602
71814869|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|22.72||||0.001|TWO_SIDED|95.0|12.39|33.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||33.05|12.39|0.001
71814870|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|60.37|||<|0.001|TWO_SIDED|95.0|48.61|72.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||72.12|48.61|<0.001
71846628|NCT02542943|143207765|SUPERIORITY_OR_OTHER||LS mean difference|0.17||||0.4538|TWO_SIDED|95.0|-0.284|0.633||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.633|-0.284|0.4538
71678582|NCT02496091|142875366|OTHER||95% confidence interval (using the exact|92.7|||||TWO_SIDED|95.0|88.8|95.5||||||Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.||95.5|88.8|
71898602|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.058||0.004|TWO_SIDED|95.0|-0.28|-0.05|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 9-12|||-0.05|-0.28|0.004
71846629|NCT02542943|143207765|SUPERIORITY_OR_OTHER||LS mean difference|-0.33||||0.1663|TWO_SIDED|95.0|-0.788|0.136||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.136|-0.788|0.1663
71846630|NCT02542943|143207766|SUPERIORITY_OR_OTHER||LS mean difference|-0.1||||0.7137|TWO_SIDED|95.0|-0.661|0.453||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.453|-0.661|0.7137
71846631|NCT02542943|143207766|SUPERIORITY_OR_OTHER||LS mean difference|0.1||||0.7353|TWO_SIDED|95.0|-0.46|0.651||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.651|-0.460|0.7353
71846632|NCT02542943|143207766|SUPERIORITY_OR_OTHER||LS mean difference|-0.2||||0.4843|TWO_SIDED|95.0|-0.76|0.361||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.361|-0.760|0.4843
71846633|NCT01767688|143207892|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.79|1.11|||Geometric least-squares mean ratio (GMR)|||||1.11|0.79|
71846634|NCT01767688|143207893|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.94|||||TWO_SIDED|95.0|0.81|1.1|||Geometric least-squares mean ratio (GMR)|||||1.10|0.81|
71846635|NCT01767688|143207894|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|0.81|||||TWO_SIDED|95.0|0.51|1.28|||Geometric least-squares mean ratio (GMR)|||||1.28|0.51|
71846636|NCT01767688|143207895|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio (GMR)|1.03|||||TWO_SIDED|95.0|0.93|1.15|||Geometric least-squares mean ratio (GMR)|||||1.15|0.93|
71846637|NCT01256359|143207965|SUPERIORITY||Hazard Ratio (HR)|0.753||||0.13|TWO_SIDED|90.0|0.498|1.138||p value \< 0.1 one-sided considered to be significant.|Regression, Cox||HR is Adjusted for M status, performance status|||1.138|0.498|0.130
71846638|NCT01256359|143207965|SUPERIORITY||Hazard Ratio (HR)|0.723||||0.113|TWO_SIDED|90.0|0.465|1.123|||Regression, Cox||This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status|This is a sensitivity analysis of the primary outcome. This includes all 83 patients but the analysis additionally adjusted for LDH, target lesion sum and time interval between randomisation and baseline CT scan as well as mstatus, performance status||1.123|0.465|0.113
71678583|NCT02272842|142875372|SUPERIORITY|The study had 80% power to detect a standardized effect size of 0.22 and had 90% power to detect an effect size of 0.28. In these calculations, we assumed a loss to follow-up of 10%. Details on the samples size calculations are also presented in the previously published protocol paper.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.35|>|0.16|TWO_SIDED|95.0|-0.54|0.87||The main analysis was the change in cognitive scores from baseline until the end of the intervention.|t-test, 2 sided||This is the P-value for the effect on the cognitive scores.|||.87|-.54|>.16
71846639|NCT01256359|143207965|SUPERIORITY|||||||0.3016||||||This analysis assesses if allowing for interval censoring is consistent with the primary outcome results.|Generalised log-rank|Generalised log-rank taking into account interval censoring, analysed using SAS package version 9.2. Method by Zhao and Sun, 2004||This is a sensitivity analysis, including all 83 randomised patients. Patients are assessed periodically for the response (progression), the time when the event occurred is not directly observed but is known to take place within some time interval. Progression is known only to have occurred at some time between visits, the exact time is not known. We carried out interval censored analysis to demonstrate if allowing for interval censoring gives a different interpretation of the primary outcome.||||0.3016
71846640|NCT01256359|143207965|SUPERIORITY||Hazard Ratio (HR)|1.348||||0.305|TWO_SIDED|90.0|0.602|3.016|||Regression, Cox||Adjusted for centre|Sensitivity analysis adjusting for centre. All 83 randomised patients were included in analysis. Centres were the three biggest recruiters and all other 13 centres are combined.||3.016|0.602|0.305
71846641|NCT01256359|143207966|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.187|TWO_SIDED|90.0|-3.4|31.4|||Log Rank||This is the estimated difference in PFS rate i.e. % difference between arms|||31.4|-3.4|0.187
71846642|NCT01256359|143207967|SUPERIORITY||Hazard Ratio (HR)|1.373||||0.169|TWO_SIDED|90.0|0.797|2.369|||Regression, Cox|p value \< 0.1 one-sided considered to be significant.||||2.369|0.797|0.169
71846643|NCT01256359|143207968|SUPERIORITY|||||||0.059|||||||Chi-squared|||Objective response rate calculated as number of patients with CR or PR over all patients randomised.||||0.059
71846644|NCT01256359|143207969|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.318|TWO_SIDED|90.0|0.71|1.84|||Regression, Cox|||Analysis adjusted for with Mstatus and Performance Score||1.84|0.71|0.318
71846645|NCT01256359|143208007|SUPERIORITY||Hazard Ratio (HR)|1.022||||0.468|TWO_SIDED|90.0|0.649|1.612|||Regression, Cox||Analysis Adjusted for M status, performance status|This is a sensitivity analysis of the primary outcome.||1.612|0.649|0.468
71846646|NCT01256359|143208008|SUPERIORITY||Hazard Ratio (HR)|0.721||||0.106|TWO_SIDED|90.0|0.468|1.109|||Regression, Cox||Analysis was adjusted for mstatus, performance status|This is the per-protocol analysis of the primary outcome.||1.109|0.468|0.106
71898603|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.061|<|0.001|TWO_SIDED|95.0|-0.34|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 13-16|||-0.10|-0.34|<0.001
71898604|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.064|<|0.001|TWO_SIDED|95.0|-0.36|-0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 17-20|||-0.11|-0.36|<0.001
71898605|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.35|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 21-24|||-0.10|-0.35|<0.001
71846647|NCT01256359|143208009|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.824|TWO_SIDED|95.0|0.25|1.53||p-value is for the interaction term|Regression, Cox||HRs (95% CI) between treatment groups are given for Wild type and NRAS mutated separately. The above HR is for WT.|Model with interaction term between NRAS status and treatment group and stratification variables||1.53|0.25|0.824
71846648|NCT01256359|143208010|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.072|TWO_SIDED|95.0|0.16|1.6||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.60|0.16|0.072
71846649|NCT01256359|143208010|SUPERIORITY||Hazard Ratio (HR)|1.97|||||TWO_SIDED|95.0|0.73|5.33|||||HR for NRAS mutated patients|||5.33|0.73|
71846650|NCT01256359|143208012|SUPERIORITY|Adjusted for with Mstatus and Performance Score|Hazard Ratio (HR)|1.12||||0.348|TWO_SIDED|90.0|0.68|1.87|||Regression, Cox|||||1.87|0.68|0.348
71846651|NCT01256359|143208013|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.797|TWO_SIDED|90.0|0.24|1.58||p-value is for interaction term.|Regression, Cox|Model includes interaction term between NRAS status and treatment group and stratification variables|"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.58|0.24|0.797
71846652|NCT01256359|143208013|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.35|1.45|||||HR for NRAS mutated patients|||1.45|0.350|
71846653|NCT01256359|143208014|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.12|TWO_SIDED|95.0|0.18|1.97||Model includes interaction term between NRAS status and treatment group and stratification variables. p-value is for interaction term.|Regression, Cox||"HRs for treatment effect (AZD6244 vs Placebo ) are estimated for NRAS WT and NRAS mutated patients separately.~Hazard ratios (95%CI) given above are for NRAS WT patients."|||1.97|0.18|0.120
71846654|NCT01256359|143208014|SUPERIORITY||Hazard Ratio (HR)|1.99|||||TWO_SIDED|95.0|0.73|5.38|||||HR for NRAS mutated patients|||5.38|0.73|
71846655|NCT02000752|143208016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||<|0.001|ONE_SIDED|95.0|7.59||||t-test, 1 sided||||||7.59|<0.001
71846656|NCT02000752|143208017|SUPERIORITY_OR_OTHER||difference in percentage|0.0||||1|TWO_SIDED|95.0|||||t-test, 2 sided|||||||1
71846657|NCT02000752|143208018|SUPERIORITY_OR_OTHER||difference in percentages|2.13||||0.16|ONE_SIDED|95.0|1.01||||t-test, 1 sided||||||1.01|0.16
71846658|NCT02000752|143208019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||0.2|ONE_SIDED|95.0|0.84||||t-test, 2 sided||||||0.84|0.2
71846659|NCT04658784|143208025|SUPERIORITY||Odds Ratio (OR)|0.51||||0.32|TWO_SIDED|95.0|0.13|1.92||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||1.92|0.13|0.32
71846660|NCT04658784|143208026|SUPERIORITY||Odds Ratio (OR)|0.48||||1|TWO_SIDED|95.0|0.04|5.65||OR, 95% CI, and p-values for outcomes adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery). P-value for VAS at 6-weeks was not adjusted for multiple comparisons.|Regression, Logistic|||OR calculated from logistic regression model, evaluating mean change in baseline VAS to 6-weeks.||5.65|0.04|1.0
71846661|NCT04658784|143208029|SUPERIORITY||Mean Difference (Net)|2.6||||1|TWO_SIDED|95.0|-3.5|8.7||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6- weeks.||8.7|-3.5|1.0
71846662|NCT04658784|143208029|SUPERIORITY||Mean Difference (Net)|-1.2|||||TWO_SIDED|95.0|-5.6|3.2||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6-months.||3.2|-5.6|
71846663|NCT04658784|143208030|SUPERIORITY||Mean Difference (Net)|0.2||||1|TWO_SIDED|95.0|-6.6|6.9||Adjust for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-weeks.||6.9|-6.6|1.0
71846664|NCT04658784|143208030|SUPERIORITY|Differences in mean change and 95% CI generated from general linear models. Change in baseline to 6-months.|Mean Difference (Net)|2.8||||1|TWO_SIDED|95.0|-3.1|8.6||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||||8.6|-3.1|1
71846665|NCT04658784|143208031|SUPERIORITY||Mean Difference (Net)|-1.6||||1|TWO_SIDED|95.0|-4.4|1.3||Adjusted for baseline value and type of surgery (vaginal or vaginal + minimally invasive surgery).|Regression, Linear|||Differences in mean change and 95% CI generated from general linear models. Change from baseline to 6 months.||1.3|-4.4|1.0
71846666|NCT02095145|143208039|OTHER|||||||0.19|||||||Wilcoxon rank-sum test|||||||0.190
71846667|NCT02095145|143208039|OTHER|||||||0.211|||||||t-test, 2 sided|||||||0.211
71846668|NCT02095145|143208042|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.948
71846669|NCT02095145|143208042|OTHER|||||||0.711|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.711
71846670|NCT02095145|143208042|OTHER|||||||0.038|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.038
71846671|NCT02095145|143208042|OTHER|||||||0.445|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.445
71846672|NCT02095145|143208043|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value||||0.743
71846673|NCT02095145|143208043|OTHER|||||||0.305|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value||||0.305
71846674|NCT02095145|143208043|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value||||0.111
71846675|NCT02095145|143208043|OTHER|||||||0.395|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value||||0.395
71846676|NCT02095145|143208044|OTHER|||||||0.743|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 13||||0.743
71846677|NCT02095145|143208044|OTHER|||||||0.527|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 26||||0.527
71846678|NCT02095145|143208044|OTHER|||||||0.879|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 39||||0.879
71846679|NCT02095145|143208044|OTHER|||||||0.81|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 52||||0.810
71846680|NCT02095145|143208045|OTHER|||||||0.556|||||||Wilcoxon rank-sum test|||Comparison of both arms at baseline||||0.556
71814871|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|2.25||||0.761|TWO_SIDED|95.0|-12.1|16.59||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||16.59|-12.10|0.761
71814872|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|58.32|||<|0.001|TWO_SIDED|95.0|46.59|70.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||70.05|46.59|<0.001
71814873|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|67.52|||<|0.001|TWO_SIDED|95.0|54.91|80.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||80.12|54.91|<0.001
71814874|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.42||||0.41|TWO_SIDED|95.0|-7.34|18.18||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||18.18|-7.34|0.410
71814875|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|62.13|||<|0.001|TWO_SIDED|95.0|48.96|75.29||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||75.29|48.96|<0.001
71814876|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|68.64|||<|0.001|TWO_SIDED|95.0|56.11|81.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||81.16|56.11|<0.001
71814877|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814878|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|63.34|||<|0.001|TWO_SIDED|95.0|50.32|76.35||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||76.35|50.32|<0.001
71814879|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71814880|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814881|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814882|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71814883|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814884|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814885|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71814886|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814887|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814888|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71846681|NCT02095145|143208045|OTHER|||||||0.647|||||||Wilcoxon rank-sum test|||comparison of both arms at Week 26||||0.647
71846682|NCT02095145|143208045|OTHER|||||||0.948|||||||Wilcoxon rank-sum test|||comparison of both arms at end of study, week 52||||0.948
71846683|NCT02095145|143208046|OTHER|||||||0.58|||||||Wilcoxon rank-sum test|||||||0.580
71846684|NCT02095145|143208047|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Benign core p-value||||0.344
71678584|NCT02272842|142875382|SUPERIORITY|the means were compared using Students t-test|Mean Difference (Final Values)|-0.5|||>|0.3|TWO_SIDED|95.0|-1.97|0.94||"Mean difference -0.5 points in the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition.~95 % Confidence Interval of the mean difference: (-1.97, 0.94)"|t-test, 2 sided|||Comparing mean differences between the two study arms||0.94|-1.97|>.3
71678585|NCT03518619|142875393|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.05||||||This is a calculated p-value.|t-test, 2 sided|||||||<.05
71678586|NCT03518619|142875394|OTHER|This is a single group design. Paired-samples t-tests were conducted.|||||<|0.01||||||This is a calculated p-value.|t-test, 2 sided|||||||<.01
71678587|NCT00519428|142875399|SUPERIORITY|Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|4.0||0.05|TWO_SIDED|||||"Each individual test will require the calculated p to be \< .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05."|Cochran-Mantel-Haenszel|||Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.||||.05
71678588|NCT00519428|142875401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|8.0||0.0916|TWO_SIDED|95.0||||escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns|ANCOVA|adjusting for baseline score and country||To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country||||.0916
71814889|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814890|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814891|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|66.44|||<|0.001|TWO_SIDED|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||79.51|53.38|<0.001
71846685|NCT02095145|143208047|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Adjacent core p-value||||0.371
71846686|NCT02095145|143208047|OTHER|||||||0.766|||||||Wilcoxon rank-sum test|||Tumor core p-value||||0.766
71846687|NCT02095145|143208048|OTHER|||||||0.304|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Nuc)||||0.304
71846688|NCT02095145|143208048|OTHER|||||||0.23|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Nuc)||||0.230
71846689|NCT02095145|143208048|OTHER|||||||0.298|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Nuc)||||0.298
71846690|NCT02095145|143208048|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cyt)||||0.247
71846691|NCT02095145|143208048|OTHER|||||||0.093|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cyt)||||0.093
71846692|NCT02095145|143208048|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cyt)||||0.066
71846693|NCT02095145|143208048|OTHER|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cell)||||0.247
71846694|NCT02095145|143208048|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cell)||||0.128
71846695|NCT02095145|143208048|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cell)||||0.128
71846696|NCT02095145|143208049|OTHER|||||||0.297|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.297
71846697|NCT02095145|143208049|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.233
71846698|NCT02095145|143208049|OTHER|||||||0.371|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.371
71846699|NCT02095145|143208049|OTHER|||||||0.198|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.198
71846700|NCT02095145|143208049|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.233
71846701|NCT02095145|143208049|OTHER|||||||0.074|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.074
71846702|NCT02095145|143208049|OTHER|||||||0.234|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.234
71846703|NCT02095145|143208049|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.233
71846704|NCT02095145|143208049|OTHER|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.233
71846705|NCT02095145|143208050|OTHER|||||||0.167|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.167
71846706|NCT02095145|143208050|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.391
71846707|NCT02095145|143208050|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.713
71846708|NCT02095145|143208050|OTHER|||||||0.452|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.452
71846709|NCT02095145|143208050|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.391
71846710|NCT02095145|143208050|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.713
71846711|NCT02095145|143208050|OTHER|||||||0.344|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.344
71678589|NCT03626363|142875411|SUPERIORITY|We sought to have up to 20 participants complete each group so that we could have a statistical power of 0.89 to detect about a 4 burst per minute difference with an alpha of 0.05. We would have had sympathetic nerve data on up to 18 more of the 21 participants that we were not allowed to post-test in the spring of 2020 due to COVID-19 restrictions.|Mean Difference (Net)|-2.0||||0.51|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in the mean number of bursts per minute of muscle sympathetic nerve activity (MSNA) from pre to post.||||0.51
71688678|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.13|0.24|||t-test, 2 sided|||FEV1 Day 1 (2 hrs post-dose)||0.24|0.13|<0.0001
71814892|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|5.31||||0.412|TWO_SIDED|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.83|-7.22|0.412
71814893|NCT01216163|143131371|SUPERIORITY_OR_OTHER||Difference in proportion|61.14|||<|0.001|TWO_SIDED|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||74.68|47.60|<0.001
71814894|NCT01216163|143131372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.22|0.08|<0.001
71814895|NCT01216163|143131372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.303|TWO_SIDED|95.0|0.45|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||1.28|0.45|0.303
71814896|NCT01216163|143131372|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.1|0.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.||0.28|0.10|<0.001
71814897|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-40.1|||<|0.001|TWO_SIDED|95.0|-55.39|-24.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.80|-55.39|<0.001
71814898|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-0.12||||0.958|TWO_SIDED|95.0|-4.52|4.28||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||4.28|-4.52|0.958
71814899|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-40.19|||<|0.001|TWO_SIDED|95.0|-55.51|-24.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-24.87|-55.51|<0.001
71814900|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-63.4|||<|0.001|TWO_SIDED|95.0|-77.81|-48.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-48.99|-77.81|<0.001
71814901|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-7.17||||0.108|TWO_SIDED|95.0|-15.91|1.57||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.57|-15.91|0.108
71814902|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-56.39|||<|0.001|TWO_SIDED|95.0|-71.68|-41.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-41.09|-71.68|<0.001
71814903|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-71.01|||<|0.001|TWO_SIDED|95.0|-84.09|-57.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-57.93|-84.09|<0.001
71846712|NCT02095145|143208050|OTHER|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.391
71846713|NCT02095145|143208050|OTHER|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.713
71846714|NCT02095145|143208051|OTHER|||||||0.865|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.865
71846715|NCT02095145|143208051|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||1.000
71846716|NCT02095145|143208051|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.066
71814904|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-9.82||||0.083|TWO_SIDED|95.0|-20.18|1.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.16|-20.18|0.083
71814905|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-61.14|||<|0.001|TWO_SIDED|95.0|-75.4|-46.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-46.87|-75.40|<0.001
71814906|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-66.37|||<|0.001|TWO_SIDED|95.0|-80.08|-52.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-52.66|-80.08|<0.001
71814907|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-11.03||||0.079|TWO_SIDED|95.0|-23.37|1.21||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.21|-23.37|0.079
71814908|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-55.53|||<|0.001|TWO_SIDED|95.0|-70.12|-40.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-40.85|-70.12|<0.001
71814909|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-57.33|||<|0.001|TWO_SIDED|95.0|-71.9|-42.77||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-42.77|-71.90|<0.001
71814910|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-7.73||||0.263|TWO_SIDED|95.0|-21.08|5.63||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||5.63|-21.08|0.263
71814911|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-49.93|||<|0.001|TWO_SIDED|95.0|-64.74|-35.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-35.12|-64.74|<0.001
71814912|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-52.75|||<|0.001|TWO_SIDED|95.0|-67.62|-37.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-37.88|-67.62|<0.001
71814913|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-5.51||||0.439|TWO_SIDED|95.0|-19.27|8.25||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.25|-19.27|0.439
71814914|NCT01216163|143131373|SUPERIORITY_OR_OTHER||Difference in proportion|-47.72|||<|0.001|TWO_SIDED|95.0|-62.62|-32.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||-32.83|-62.62|<0.001
71814915|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|-1.21||||0.294|TWO_SIDED|95.0|-3.59|1.17||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||1.17|-3.59|0.294
71846717|NCT02095145|143208052|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Benign p-value||||1.000
71846718|NCT02095145|143208052|OTHER|||||||0.903|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Adjacent p-value||||0.903
71846719|NCT02095145|143208052|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Tumor p-value||||1.000
71898606|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.049|<|0.001|TWO_SIDED|95.0|-0.37|-0.18|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 1-4|||-0.18|-0.37|<0.001
71846720|NCT02095145|143208052|OTHER|||||||0.269|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Benign p-value||||0.269
71846721|NCT02095145|143208052|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Adjacent p-value||||0.066
71846722|NCT02095145|143208052|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Tumor p-value||||1.000
71846723|NCT02095145|143208052|OTHER|||||||0.425|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Benign p-value||||0.425
71846724|NCT02095145|143208052|OTHER|||||||0.27|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Adjacent p-value||||0.270
71898607|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.46|-0.23|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 5-8|||-0.23|-0.46|<0.001
71678590|NCT03626363|142875412|SUPERIORITY|To detect a 0.5 meter per second change in carotid-to-femoral pulse wave velocity with at least 80% power with an alpha of 0.05 we should have had at least 12 participants complete measurements in each group (MBSR and SME). We fell a little short of that in the MBSR group and met the 12 participants in the SME group. The number of participants we were able to study from pre to post was limited by COVID-19 restrictions.|Mean Difference (Net)|-0.2||||0.25|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in carotid-to-femoral pulse wave velocity in meters per second from pre to post. We had 21 participants in the spring of 2020 that were were not allowed to bring into the laboratory for post testing during COVID-19 restrictions which led to our limited sample size.||||0.25
71678591|NCT03053063|142875434|SUPERIORITY||Percentage Difference|1.9||||0.5572|TWO_SIDED|95.0|-4.4|8.2||Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-4.4|0.5572
71678592|NCT03053063|142875434|SUPERIORITY||Percentage Difference|0.3||||0.9272|TWO_SIDED|95.0|-6.0|6.5||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||6.5|-6.0|0.9272
71678593|NCT03053063|142875437|SUPERIORITY||Percentage Difference|3.8||||0.285|TWO_SIDED|95.0|-3.1|10.6||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||10.6|-3.1|0.2850
71678594|NCT03053063|142875437|SUPERIORITY||Percentage Difference|1.5||||0.6731|TWO_SIDED|95.0|-5.3|8.2||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||8.2|-5.3|0.6731
71678595|NCT03053063|142875439|SUPERIORITY||Percentage Difference|-1.7||||0.365|TWO_SIDED|95.0|-5.5|2.0||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||2.0|-5.5|0.3650
71814916|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|1.21||||0.458|TWO_SIDED|95.0|-1.16|3.58||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||3.58|-1.16|0.458
71814917|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|6.81||||0.073|TWO_SIDED|95.0|1.57|12.06||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||12.06|1.57|0.073
71814918|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|1.96||||0.583|TWO_SIDED|95.0|-4.94|8.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||8.85|-4.94|0.583
71814919|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|4.81||||0.137|TWO_SIDED|95.0|0.14|9.49||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||9.49|0.14|0.137
71814920|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|23.86|||<|0.001|TWO_SIDED|95.0|14.81|32.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||32.91|14.81|<0.001
71814921|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|8.45||||0.165|TWO_SIDED|95.0|-3.43|20.33||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.33|-3.43|0.165
71814922|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|15.46||||0.006|TWO_SIDED|95.0|7.66|23.26||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.26|7.66|0.006
71814923|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|29.41|||<|0.001|TWO_SIDED|95.0|19.78|39.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.05|19.78|<0.001
71846725|NCT02095145|143208052|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Tumor p-value||||1.000
71846726|NCT02095145|143208053|OTHER|||||||0.625|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value||||0.625
71846727|NCT02095145|143208053|OTHER|||||||0.128|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value||||0.128
71846728|NCT02095145|143208053|OTHER|||||||0.045|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value||||0.045
71846729|NCT02095145|143208053|OTHER|||||||0.105|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value||||0.105
71846730|NCT02095145|143208053|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value||||0.066
71846731|NCT02095145|143208053|OTHER|||||||0.005|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value||||0.005
71898608|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.47|-0.21|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 9-12|||-0.21|-0.47|<0.001
71898609|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.068|<|0.001|TWO_SIDED|95.0|-0.51|-0.25|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 13-16|||-0.25|-0.51|<0.001
71898610|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.53|-0.26|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 17-20|||-0.26|-0.53|<0.001
71846732|NCT02095145|143208053|OTHER|||||||0.129|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value||||0.129
71846733|NCT02095145|143208053|OTHER|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value||||0.066
71846734|NCT02095145|143208053|OTHER|||||||0.013|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value||||0.013
71846735|NCT02095145|143208054|OTHER|||||||0.143|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value||||0.143
71846736|NCT02095145|143208054|OTHER|||||||0.037|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value||||0.037
71846737|NCT02095145|143208054|OTHER|||||||0.111|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value||||0.111
71846738|NCT02095145|143208055|OTHER|||||||0.068|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||0.068
71846739|NCT02095145|143208055|OTHER|||||||0.004|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.004
71846740|NCT02095145|143208055|OTHER|||||||0.002|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.002
71846741|NCT02095145|143208055|OTHER||||||<|0.001|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||<0.001
71898611|NCT02345161|143320729|SUPERIORITY_OR_OTHER||LS Mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.072|<|0.001|TWO_SIDED|95.0|-0.5|-0.22|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 21-24|||-0.22|-0.50|<0.001
71898612|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.311||0.094|TWO_SIDED|95.0|-1.13|0.09|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4|||0.09|-1.13|0.094
71898613|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.07|STANDARD_ERROR_OF_MEAN|0.371||0.004|TWO_SIDED|95.0|-1.8|-0.34|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8|||-0.34|-1.80|0.004
71846742|NCT02095145|143208056|OTHER|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13||||1.000
71846743|NCT02095145|143208056|OTHER|||||||0.18|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26||||0.180
71846744|NCT02095145|143208056|OTHER|||||||0.62|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39||||0.620
71846745|NCT02095145|143208056|OTHER|||||||0.536|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52||||0.536
71846746|NCT02095145|143208058|OTHER|||||||0.231|||||||Wilcoxon rank-sum test|||Change in Tumor Volume from baseline to end of study per arm||||0.231
71846747|NCT00670488|143208076|OTHER||AUC0-48hr GMR|3.26||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71846748|NCT00670488|143208076|OTHER||AUC 0-48hr GMR|3.18||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71846749|NCT00670488|143208077|OTHER||Cmax GMR|2.59||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71846750|NCT00670488|143208077|OTHER||Cmax GMR|2.67||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71846751|NCT00670488|143208078|OTHER||C48hr GMR|4.33||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71846752|NCT00670488|143208078|OTHER||C48hr GMR|3.58||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."||||
71846753|NCT00670488|143208081|OTHER||AUC0-168hr GMR|1.91||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
71846754|NCT00670488|143208081|OTHER||AUC 0-168hr GMR|1.54||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.||||
71846755|NCT00670488|143208082|OTHER||Cmax GMR|1.95||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
71898614|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.419||0.022|TWO_SIDED|95.0|-1.79|-0.14|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12|||-0.14|-1.79|0.022
71898615|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.445||0.024|TWO_SIDED|95.0|-1.88|-0.13|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16|||-0.13|-1.88|0.024
71898616|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20|||-0.17|-2.06|0.021
71814924|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|4.61||||0.497|TWO_SIDED|95.0|-8.78|17.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||17.99|-8.78|0.497
71846756|NCT00670488|143208082|OTHER||Cmax GMR|1.33||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.||||
71678596|NCT03053063|142875439|SUPERIORITY||Percentage Difference|-0.4||||0.8557|TWO_SIDED|95.0|-4.3|3.6||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (\<11.27 vs ≥11.27).|Mantel Haenszel|||||3.6|-4.3|0.8557
71846757|NCT00670488|143208083|OTHER||C48hr GMR|1.61||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
71846758|NCT00670488|143208083|OTHER||C48hr GMR|1.86||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
71846759|NCT00670488|143208083|OTHER||C48hr GMR|1.49||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.||||
71846760|NCT00670488|143208086|OTHER||GMR|0.133|||||TWO_SIDED|95.0|0.051|0.347||||||"pAkt Geometric Mean Ratio (GMR)~= Day 15 Geometric Mean (GM) ÷ Baseline GM"||0.347|0.051|
71846761|NCT01034306|143208106|SUPERIORITY|||||||0.0352||||||normal approximation to the binomial test|t-test, 2 sided|||||||0.0352
71846762|NCT01034306|143208107|SUPERIORITY|||||||0.2472|||||||t-test, 2 sided|||||||.2472
71846763|NCT01034306|143208108|SUPERIORITY|||||||0.1972|||||||t-test, 2 sided|||||||0.1972
71846764|NCT01619059|143208122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.087|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||Tested at alpha=0.05|Mixed Models Analysis|||||-0.18|-0.52|<0.0001
71846765|NCT01619059|143208123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|4.576||0.2014|TWO_SIDED|95.0|-14.9|3.1||Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure|Mixed Models Analysis|||||3.1|-14.9|0.2014
71846766|NCT01619059|143208124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.713|||TWO_SIDED|95.0|-11.0|3.6||||||||3.6|-11.0|
71846767|NCT01619059|143208125|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|4.504|||TWO_SIDED|95.0|3.4|21.0||||||||21.0|3.4|
71846768|NCT03418545|143208126|SUPERIORITY||Percentage difference|67.5|||<|0.0001|TWO_SIDED|95.0|52.9|82.0||The p-value and 95% CI are computed by pooling 5 imputed datasets using PROC MIANALYZE in SAS with normal approximation. The p-value and 95% CI for each imputed data set is based on the Fisher's exact test and the Wald test, respectively.|Fisher Exact|||||82.0|52.9|<0.0001
71678597|NCT01953874|142875464|OTHER|The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang.||||||0.916|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects.||||0.916
71898617|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.481||0.022|TWO_SIDED|95.0|-2.05|-0.16|||Mixed Model Repeated Measures||EXACT-RS Score, Week 21-24|||-0.16|-2.05|0.022
71846769|NCT03418545|143208127|SUPERIORITY||Percentage difference|73.5|||||TWO_SIDED|95.0|60.2|86.8|||||The 95% CI is based on the Wald test.|||86.8|60.2|
71846770|NCT03418545|143208129|SUPERIORITY||||||<|0.0001||||||A 2-sided paired t-test at the 5% level was performed to demonstrate that the mean overall satisfaction score at Month 3 was statistically greater than that at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
71846771|NCT01989793|143208153|EQUIVALENCE|Equivalence margin=0||||||0.97|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 8||||0.97
71846772|NCT01989793|143208154|EQUIVALENCE|Equivalence margin=0||||||0.48|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 16||||0.48
71846773|NCT01989793|143208155|EQUIVALENCE|Equivalence margin = 0||||||0.59|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 24||||0.59
71846774|NCT01989793|143208156|EQUIVALENCE|Equivalence margin=0||||||0.212|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 8||||0.212
71846775|NCT01989793|143208157|EQUIVALENCE|Equivalence margin=0||||||0.271|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 16||||0.271
71846776|NCT01989793|143208158|EQUIVALENCE|Equivalence margin=0||||||0.203|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 24||||0.203
71846777|NCT01989793|143208159|EQUIVALENCE|Equivalence margin = 0||||||0.82|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.82
71846778|NCT01989793|143208160|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
71846779|NCT01989793|143208161|EQUIVALENCE|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms||||0.73
71846780|NCT01836445|143208240|SUPERIORITY||Prevalence Ratio|0.9||||0.2|TWO_SIDED|95.0|0.76|1.06|||Regression, Logistic|||||1.06|0.76|0.20
71846781|NCT01836445|143208241|SUPERIORITY||Prevalence Ratio|0.95||||0.6|TWO_SIDED|95.0|0.8|1.14|||Regression, Logistic|||||1.14|0.80|0.60
71846782|NCT01836445|143208242|SUPERIORITY||Prevalence Ratio|0.83||||0.04|TWO_SIDED|95.0|0.7|0.99|||Regression, Logistic|||||0.99|0.70|0.04
71846783|NCT01836445|143208244|SUPERIORITY||Risk Ratio (RR)|0.6||||0.01|TWO_SIDED|95.0|0.38|0.95|||Z-test|||||0.95|0.38|0.01
71846784|NCT01836445|143208245|OTHER|Generalized Linear Mixed Model statistical test used||||||0.15|||||||Regression, Linear|||||||0.150
71846785|NCT01836445|143208246|OTHER|Generalized Linear Mixed Model statistical test used||||||0.374|||||||Regression, Linear|||||||0.374
71898618|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.492||0.008|TWO_SIDED|95.0|-2.29|-0.35|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 25-28|||-0.35|-2.29|0.008
71898619|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.43|STANDARD_ERROR_OF_MEAN|0.494||0.004|TWO_SIDED|95.0|-2.4|-0.46|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 29-32|||-0.46|-2.40|0.004
71678598|NCT03339726|142875484|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.22||0.3|TWO_SIDED|95.0|-0.205|0.662||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.662|-0.205|0.300
71846786|NCT01836445|143208247|OTHER|Generalized Linear Mixed Model statistical test used||||||0.919|||||||Regression, Linear|||Analysis for Motivation items||||0.919
71846787|NCT01836445|143208247|OTHER|Generalized Linear Mixed Model statistical test used||||||0.493|||||||Regression, Linear|||Analysis for Social Norms items||||0.493
71846788|NCT01836445|143208247|OTHER|Generalized Linear Mixed Model statistical test used||||||0.002|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.002
71846789|NCT01836445|143208248|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.067
71846790|NCT01836445|143208248|OTHER|Generalized Linear Mixed Model statistical test used||||||0.135|||||||Regression, Linear|||Analysis for Condom Use items||||0.135
71846791|NCT01836445|143208248|OTHER|Generalized Linear Mixed Model statistical test used||||||0.025|||||||Regression, Linear|||Analysis for HIV Testing items||||0.025
71846792|NCT01836445|143208249|OTHER|Generalized Linear Mixed Model statistical test used||||||0.138|||||||Regression, Logistic|||||||0.138
71846793|NCT01836445|143208250|OTHER|Generalized Linear Mixed Model statistical test used||||||0.173|||||||Regression, Linear|||||||0.173
71846794|NCT01836445|143208251|OTHER|Generalized Linear Mixed Model statistical test used||||||0.567|||||||Regression, Linear|||||||0.567
71846795|NCT01836445|143208252|OTHER|Generalized Linear Mixed Model statistical test used||||||0.861|||||||Regression, Linear|||Analysis for motivation items||||0.861
71846796|NCT01836445|143208252|OTHER|Generalized Linear Mixed Model statistical test used||||||0.628|||||||Regression, Linear|||Analysis for social norms items||||0.628
71846797|NCT01836445|143208252|OTHER|Generalized Linear Mixed Model statistical test used||||||0.151|||||||Regression, Linear|||Analysis for behavioral skills items||||0.151
71846798|NCT01836445|143208253|OTHER|Generalized Linear Mixed Model statistical test used||||||0.001|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.001
71846799|NCT01836445|143208253|OTHER|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Condom Use items||||0.067
71846800|NCT01836445|143208253|OTHER|Generalized Linear Mixed Model statistical test used||||||0.637|||||||Regression, Linear|||Analysis for HIV Testing items||||0.637
71846801|NCT01836445|143208254|OTHER|Generalized Linear Mixed Model statistical test used||||||0.862|||||||Regression, Linear|||||||0.862
71846802|NCT01836445|143208255|OTHER|Generalized Linear Mixed Model statistical test used||||||0.762|||||||Regression, Linear|||||||0.762
71846803|NCT01836445|143208256|SUPERIORITY|||||||0.043|||||||Regression, Linear|||Analysis for Motivation items||||0.043
71846804|NCT01836445|143208256|SUPERIORITY|||||||0.617|||||||Regression, Linear|||Analysis for Social Norm items||||0.617
71846805|NCT01836445|143208256|SUPERIORITY|||||||0.57|||||||Regression, Linear|||Analysis for Behavioral Skills items||||0.570
71846806|NCT01836445|143208257|SUPERIORITY|||||||0.036|||||||Regression, Linear|||Analysis for Relationship Maintenance items||||0.036
71846807|NCT01836445|143208257|SUPERIORITY|||||||0.837|||||||Regression, Linear|||Analysis for Condom Use items||||0.837
71846808|NCT01836445|143208257|SUPERIORITY|||||||0.953|||||||Regression, Linear|||Analysis for HIV Testing items||||0.953
71846809|NCT01836445|143208258|SUPERIORITY|||||||0.719|||||||Regression, Linear|||||||0.719
71846810|NCT03365622|143208290|SUPERIORITY||Mean Difference (Final Values)|6.306|STANDARD_ERROR_OF_MEAN|7.379||0.3938|TWO_SIDED|95.0|-8.242|20.854|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the total opioid dose administered intraoperatively and postoperatively, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||20.854|-8.242|0.3938
71846811|NCT03365622|143208291|SUPERIORITY||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.283||0.7051|TWO_SIDED|95.0|-0.451|0.666|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.666|-0.451|0.7051
71882302|NCT03070470|143283463|OTHER|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|30.7|||||TWO_SIDED|90.0|22.6|38.9|||Mixed Models Analysis|The degrees of freedom for the model estimates were determined by the Kenward-Rogers method as prespecified in the SAP.||Upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model.||38.9|22.6|
71882303|NCT01732796|143283465|SUPERIORITY_OR_OTHER||Adjusted response rate|81.4|||<|0.0001|TWO_SIDED|95.0|76.6|86.2|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||86.2|76.6|<0.0001
71814925|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|25.13|||<|0.001|TWO_SIDED|95.0|15.81|34.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||34.46|15.81|<0.001
71678599|NCT03339726|142875484|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.222||0.569|TWO_SIDED|95.0|-0.311|0.564||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.564|-0.311|0.569
71678600|NCT03339726|142875484|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.22||0.645|TWO_SIDED|95.0|-0.537|0.333||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.333|-0.537|0.645
71678601|NCT03339726|142875485|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.346|TWO_SIDED|95.0|-0.267|0.759||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.759|-0.267|0.346
71678602|NCT03339726|142875485|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.263||0.938|TWO_SIDED|95.0|-0.498|0.539||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.498|0.938
71678603|NCT03339726|142875485|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.261||0.389|TWO_SIDED|95.0|-0.741|0.289||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.289|-0.741|0.389
71898620|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.519||0.004|TWO_SIDED|95.0|-2.52|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 33-36|||-0.48|-2.52|0.004
71678604|NCT03339726|142875486|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.23||0.607|TWO_SIDED|95.0|-0.33|0.57|||ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.33|0.607
71678605|NCT03339726|142875486|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.232||0.085|TWO_SIDED|95.0|-0.06|0.86||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.86|-0.06|0.085
71678606|NCT03339726|142875486|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.22|TWO_SIDED|95.0|-0.17|0.74||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.17|0.220
71814926|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|31.78|||<|0.001|TWO_SIDED|95.0|20.03|43.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||43.53|20.03|<0.001
71814927|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|6.7||||0.349|TWO_SIDED|95.0|-7.38|20.79||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||20.79|-7.38|0.349
71814928|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|25.34|||<|0.001|TWO_SIDED|95.0|13.73|36.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||36.94|13.73|<0.001
71814929|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|37.64|||<|0.001|TWO_SIDED|95.0|25.47|49.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.81|25.47|<0.001
71814930|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|8.85||||0.233|TWO_SIDED|95.0|-5.72|23.42||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||23.42|-5.72|0.233
71814931|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|28.96|||<|0.001|TWO_SIDED|95.0|17.17|40.75||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||40.75|17.17|<0.001
71814932|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|38.73|||<|0.001|TWO_SIDED|95.0|25.87|51.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.60|25.87|<0.001
71898621|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.507||0.016|TWO_SIDED|95.0|-2.22|-0.23|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 37-40|||-0.23|-2.22|0.016
71678607|NCT03339726|142875487|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.271||0.633|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.633
71814933|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
71814934|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|29.19|||<|0.001|TWO_SIDED|95.0|16.71|41.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||41.66|16.71|<0.001
71814935|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|36.55|||<|0.001|TWO_SIDED|95.0|23.22|49.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||49.88|23.22|<0.001
71814936|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|9.83||||0.189|TWO_SIDED|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||24.45|-4.80|0.189
71846812|NCT03365622|143208292|SUPERIORITY||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.317||0.3852|TWO_SIDED|95.0|-0.349|0.901|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op average surgical pain, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.901|-0.349|0.3852
71814937|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
71814938|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|37.72|||<|0.001|TWO_SIDED|95.0|24.36|51.07||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||51.07|24.36|<0.001
71814939|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|10.97||||0.144|TWO_SIDED|95.0|-3.67|25.61||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||25.61|-3.67|0.144
71814940|NCT01216163|143131374|SUPERIORITY_OR_OTHER||Difference in proportion|26.97|||<|0.001|TWO_SIDED|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.||39.94|14.00|<0.001
71814941|NCT01216163|143131375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.87|||<|0.001|TWO_SIDED|95.0|0.78|0.96||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.96|0.78|<0.001
71814942|NCT01216163|143131375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.02|TWO_SIDED|95.0|0.05|0.45||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic.||0.45|0.05|0.020
71814943|NCT01216163|143131375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|||<|0.001|TWO_SIDED|95.0|0.63|0.91||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.||0.91|0.63|<0.001
71814944|NCT02413463|143131418|SUPERIORITY|Chi-square test||||||0.18||||||This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group|Chi-squared|||An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted||||0.18
71814945|NCT02413463|143131419|SUPERIORITY|||||||0.22||||||This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)|t-test, 2 sided|||||||0.22
71898622|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.49|STANDARD_ERROR_OF_MEAN|0.513||0.04|TWO_SIDED|95.0|-2.5|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 41-44|||-0.48|-2.50|0.04
71678608|NCT03339726|142875487|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.273||0.952|TWO_SIDED|95.0|-0.52|0.56||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.52|0.952
71814946|NCT02413463|143131420|SUPERIORITY|||||||0.02||||||This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)|t-test, 2 sided|||||||0.02
71814947|NCT02413463|143131421|SUPERIORITY|||||||0.03||||||This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||0.03
71814948|NCT02413463|143131422|SUPERIORITY||||||<|0.01||||||This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group|t-test, 2 sided|||||||<0.01
71814949|NCT00125593|143131427|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.0021|TWO_SIDED|95.0|0.74|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.74|0.0021
71814950|NCT00125593|143131428|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.0012|TWO_SIDED|95.0|0.77|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.77|0.0012
71814951|NCT00125593|143131429|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.001|TWO_SIDED|95.0|0.75|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.75|0.001
71814952|NCT00125593|143131430|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.37|TWO_SIDED|95.0|0.76|1.11|||Log Rank|||All analyses by intention to treat||1.11|0.76|0.37
71814953|NCT00125593|143131431|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.6|0.94|||Log Rank|||All analyses by intention to treat||0.94|0.60|0.01
71814954|NCT00125593|143131432|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.0036|TWO_SIDED|95.0|0.68|0.93|||Log Rank|||All analyses by intention to treat||0.93|0.68|0.0036
71814955|NCT00125593|143131433|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.41|TWO_SIDED|95.0|0.89|1.05|||Log Rank|||All analyses by intention to treat||1.05|0.89|0.41
71814956|NCT01597505|143131434|NON_INFERIORITY|Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.|Difference in percentage of participants|-4.6|||||TWO_SIDED|95.0|-11.0|1.9|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in percentage of participants||1.9|-11.0|
71814957|NCT01597505|143131435|SUPERIORITY|||||||0.832||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified log-rank test p-value||||0.832
71678609|NCT03339726|142875487|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.272||0.678|TWO_SIDED|95.0|-0.65|0.42||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.65|0.678
71814958|NCT01597505|143131436|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-0.8|||||TWO_SIDED|95.0|-8.8|7.1|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||7.1|-8.8|
71814959|NCT01597505|143131440|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-7.2|8.3|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||8.3|-7.2|
71814960|NCT01597505|143131441|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-3.5|||||TWO_SIDED|95.0|-10.0|3.0|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants||3.0|-10.0|
71814961|NCT01597505|143131442|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.431||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.431
71814962|NCT01597505|143131443|SUPERIORITY|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.011||||||Log-rank test of equality of survival times, stratified by age group (\< 75, \>= 75 years) and number of CDAD episodes (0, \>= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value||||0.011
71814963|NCT01597505|143131444|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|2.2|||||TWO_SIDED|95.0|-10.7|14.8|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||14.8|-10.7|
71814964|NCT01597505|143131445|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|-2.4|||||TWO_SIDED|95.0|-7.8|3.0|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||3.0|-7.8|
71814965|NCT01597505|143131446|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|14.6|||||TWO_SIDED|95.0|-2.7|30.7|||||Treatment group percentages were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants||30.7|-2.7|
71898623|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.53|STANDARD_ERROR_OF_MEAN|0.525||0.007|TWO_SIDED|95.0|-2.56|-0.5|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 45-49|||-0.50|-2.56|0.007
71678610|NCT03339726|142875488|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.25||0.126|TWO_SIDED|95.0|-0.11|0.88||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.88|-0.11|0.126
71678611|NCT03339726|142875488|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.253||0.27|TWO_SIDED|95.0|-0.22|0.78||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-0.22|0.270
71814966|NCT01597505|143131447|SUPERIORITY|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \> 0%.|Difference in percentage of participants|4.3|||||TWO_SIDED|95.0|-4.2|12.7|||||Treatment group proportions were stratified by age group (\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants||12.7|-4.2|
71814967|NCT05454410|143131464|SUPERIORITY||Mean Difference (Net)|-5.2|||||TWO_SIDED|90.0|-9.6|-0.7|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||-0.7|-9.6|
71814968|NCT05454410|143131464|SUPERIORITY||Mean Difference (Net)|-2.5|||||TWO_SIDED|90.0|-7.0|2.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||2.1|-7.0|
71814969|NCT05454410|143131464|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|90.0|-4.0|5.1|||ANCOVA||Placebo adjusted means (MIJ821-Placebo). 90% CIs are nominal and not adjusted for multiplicity.|||5.1|-4.0|
71814970|NCT05454410|143131470|SUPERIORITY|||||||0.0242||||||P-value for the selected model best representing the underlying DR (the lowest p-value out of the 6 candidate models), adjusted for multiple comparisons.|Multiple contrast test|||MCP-Mod was used to check if there was a DR relationship between the change from baseline to 24 hours in MADRS total score and the doses received. The Least squares means under the primary estimand were used to test the null hypothesis of a flat DR relationship at a one-sided significance level of 5% against the alternative hypothesis of a non-flat DR curve. Six candidate DR curves were used to derive the optimal model contrasts for the multiple contrast tests. A monotone DR was assumed.||||0.0242
71814971|NCT05807919|143131533|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71814972|NCT05807919|143131534|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
71814973|NCT05807919|143131535|SUPERIORITY|||||||0.18|||||||Fisher Exact|||||||0.18
71814974|NCT05807919|143131536|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71814975|NCT05807919|143131537|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
71814976|NCT05807919|143131538|SUPERIORITY|||||||0.48|||||||Fisher Exact|||||||0.48
71814977|NCT01557322|143131539|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Chi-squared|||Morning Stiffness \> 1 Hour: p-value was calculated using chi-square test.||||0.010
71846813|NCT03365622|143208293|SUPERIORITY||Mean Difference (Final Values)|0.534|STANDARD_ERROR_OF_MEAN|2.816||0.8498|TWO_SIDED|95.0|-5.02|6.088|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||6.088|-5.02|0.8498
71846814|NCT03365622|143208294|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|3.007||0.5839|TWO_SIDED|95.0|-7.579|4.28|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op inspiratory capacity percentage, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||4.28|-7.579|0.5839
71846815|NCT03365622|143208295|SUPERIORITY||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.344||0.2479|TWO_SIDED|95.0|-0.28|1.078|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 1-2 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.078|-0.280|0.2479
71846816|NCT03365622|143208296|SUPERIORITY||Mean Difference (Final Values)|0.484|STANDARD_ERROR_OF_MEAN|0.335||0.1502|TWO_SIDED|95.0|-0.177|1.145|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op dynamic pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.145|-0.177|0.1502
71814978|NCT01557322|143131539|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Arthritis or Deformity of 3 or More Joint Areas: p-value was calculated using chi-square test.||||<0.001
71814979|NCT01557322|143131539|SUPERIORITY_OR_OTHER|||||||0.363|TWO_SIDED||||||Chi-squared|||Arthritis/Deformity of Hand/Joint: p-value was calculated using chi-square test.||||0.363
71814980|NCT01557322|143131539|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Symmetry: p-value was calculated using chi-square test.||||<0.001
71814981|NCT01557322|143131539|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Nodules: p-value was calculated using chi-square test.||||<0.001
71814982|NCT01557322|143131539|SUPERIORITY_OR_OTHER|||||||0.605|TWO_SIDED||||||Chi-squared|||Rheumatoid Factor Positive: p-value was calculated using chi-square test.||||0.605
71898624|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.524||0.007|TWO_SIDED|95.0|-2.45|-0.39|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 49-52|||-0.39|-2.45|0.007
71898625|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.169||0.051|TWO_SIDED|95.0|-0.66|0.0|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 1-4|||0.00|-0.66|0.051
71814983|NCT01557322|143131539|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Chi-squared|||Erosions on Hand or Feet X-Ray: p-value was calculated using chi-square test.||||0.038
71814984|NCT01557322|143131540|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Sicca Syndrome: p-value was calculated using chi-square test.||||<0.001
71814985|NCT01557322|143131540|SUPERIORITY_OR_OTHER|||||||0.024|TWO_SIDED||||||Chi-squared|||Serosal Involvement: p-value was calculated using chi-square test.||||0.024
71814986|NCT01557322|143131540|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Chi-squared|||Eye Involvement: p-value was calculated using chi-square test.||||0.257
71814987|NCT01557322|143131540|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||Chi-squared|||Systemic Vasculitis: p-value was calculated using chi-square test.||||0.026
71814988|NCT01557322|143131540|SUPERIORITY_OR_OTHER|||||||0.725|TWO_SIDED||||||Chi-squared|||Nailfold Vasculitis: p-value was calculated using chi-square test.||||0.725
71814989|NCT01557322|143131540|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared|||Pulmonary Fibrosis: p-value was calculated using chi-square test.||||0.220
71814990|NCT01557322|143131540|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||Chi-squared|||Other: p-value was calculated using chi-square test.||||0.620
71814991|NCT01557322|143131541|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Knee Replacement: p-value was calculated using chi-square test.||||<0.001
71814992|NCT01557322|143131541|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Hip Replacement: p-value was calculated using chi-square test.||||<0.001
71814993|NCT01557322|143131541|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Shoulder Replacement: p-value was calculated using chi-square test.||||<0.001
71898626|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.207||0.003|TWO_SIDED|95.0|-1.02|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 5-8|||-0.20|-1.02|0.003
71814994|NCT01557322|143131541|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Total Elbow Replacement: p-value was calculated using chi-square test.||||<0.001
71814995|NCT01557322|143131541|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test.||||0.001
71814996|NCT01557322|143131541|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Neck Surgery: p-value was calculated using chi-square test.||||<0.001
71814997|NCT01557322|143131542|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||P-value was calculated using chi-square test.||||<0.001
71898627|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.234||0.01|TWO_SIDED|95.0|-1.07|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 9-12|||-0.15|-1.07|0.010
71814998|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Chi-squared|||High Blood Pressure: p-value was calculated using chi-square test.||||0.381
71814999|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Chi-squared|||Angina: p-value was calculated using chi-square test.||||0.006
71815000|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED||||||Chi-squared|||Heart Attack: p-value was calculated using chi-square test.||||0.215
71815001|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.117|TWO_SIDED||||||Chi-squared|||Stroke: p-value was calculated using chi-square test.||||0.117
71815002|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Epilepsy: p-value was calculated using chi-square test.||||1.000
71898628|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.247||0.013|TWO_SIDED|95.0|-1.1|-0.13|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 13-16|||-0.13|-1.10|0.013
71815003|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.542|TWO_SIDED||||||Chi-squared|||Asthma: p-value was calculated using chi-square test.||||0.542
71815004|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.027|TWO_SIDED||||||Chi-squared|||Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test.||||0.027
71815005|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED||||||Chi-squared|||Peptic Ulcer: p-value was calculated using chi-square test.||||0.566
71815006|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||Liver Disease: p-value was calculated using chi-square test.||||0.003
71815007|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.526|TWO_SIDED||||||Chi-squared|||Renal Disease: p-value was calculated using chi-square test.||||0.526
71815008|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED||||||Chi-squared|||Tuberculosis: p-value was calculated using chi-square test.||||0.802
71815009|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Demyelination: p-value was calculated using chi-square test.||||1.000
71815010|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||Chi-squared|||Diabetes: p-value was calculated using chi-square test.||||0.385
71815011|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Chi-squared|||Hyperthyroidism: p-value was calculated using chi-square test.||||0.048
71815012|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED||||||Chi-squared|||Depression: p-value was calculated using chi-square test.||||0.308
71815013|NCT01557322|143131543|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|||Cancer: p-value was calculated using chi-square test.||||0.033
71815014|NCT01557322|143131544|SUPERIORITY_OR_OTHER|||||||0.188|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||0.188
71815015|NCT01557322|143131545|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Systolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.016
71898629|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.265||0.012|TWO_SIDED|95.0|-1.19|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 17-20|||-0.15|-1.19|0.012
71898630|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.268||0.018|TWO_SIDED|95.0|-1.16|-0.11|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 21-24|||-0.11|-1.16|0.018
71678612|NCT03339726|142875488|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.251||0.676|TWO_SIDED|95.0|-0.6|0.39||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.39|-0.60|0.676
71815016|NCT01557322|143131545|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||t-test, 2 sided|||Diastolic Blood Pressure: p-value was calculated using 2-sided t-test.||||0.369
71678613|NCT03339726|142875489|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.264||0.421|TWO_SIDED|95.0|-0.31|0.73||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.31|0.421
71815017|NCT01557322|143131546|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
71815018|NCT01557322|143131546|SUPERIORITY_OR_OTHER|||||||0.3746|TWO_SIDED||||||Regression, Linear|||Change at Month 60: p-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.3746
71815019|NCT01557322|143131547|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
71815020|NCT01557322|143131548|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
71815021|NCT01557322|143131549|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.154
71815022|NCT01557322|143131550|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.108
71815023|NCT01557322|143131551|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||0.199
71846817|NCT03365622|143208297|SUPERIORITY||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.313||0.2797|TWO_SIDED|95.0|-0.278|0.955|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and the 20-24 hours post-op surgical pain score, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.955|-0.278|0.2797
71815024|NCT01557322|143131552|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
71898631|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.275||0.006|TWO_SIDED|95.0|-1.3|-0.21|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 25-28|||-0.21|-1.30|0.006
71815025|NCT01557322|143131553|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.||||<0.001
71815026|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
71815027|NCT01557322|143131555|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||Current DMARDs, Azathioprine: p-value was calculated using chi-square test.||||0.313
71815028|NCT01557322|143131555|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||1.000
71815029|NCT01557322|143131555|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED||||||Chi-squared|||Current DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||0.066
71815030|NCT01557322|143131555|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Chi-squared|||Current DMARDs, Leflunomide: p-value was calculated using chi-square test.||||0.099
71815031|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test.||||<0.001
71815032|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Methotrexate: p-value was calculated using chi-square test.||||<0.001
71815033|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Azathioprine: p-value was calculated using chi-square test.||||<0.001
71815034|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.||||<0.001
71815035|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test.||||<0.001
71815036|NCT01557322|143131555|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Previous DMARDs, Leflunomide: p-value was calculated using chi-square test.||||<0.001
71815037|NCT01557322|143131556|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.||||<0.001
71815038|NCT01557322|143131557|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Baseline PCS: p-value was calculated using 2-sided t-test.||||<0.001
71815039|NCT01557322|143131557|SUPERIORITY_OR_OTHER|||||||0.886|TWO_SIDED||||||t-test, 2 sided|||Baseline MCS: p-value was calculated using 2-sided t-test.||||0.886
71815040|NCT01557322|143131557|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||t-test, 2 sided|||Baseline Vitality Score: p-value was calculated using 2-sided t-test.||||0.680
71815041|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.0233|TWO_SIDED||||||Chi-squared|||Month 6: p-value was calculated using chi-square test.||||0.0233
71815042|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.5103|TWO_SIDED||||||Chi-squared|||Month 12: p-value was calculated using chi-square test.||||0.5103
71815043|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||Chi-squared|||Month 18: p-value was calculated using chi-square test.||||0.9990
71815044|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.6495|TWO_SIDED||||||Chi-squared|||Month 24: p-value was calculated using chi-square test.||||0.6495
71815045|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Month 30: p-value was calculated using chi-square test.||||0.3829
71815046|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.1085|TWO_SIDED||||||Chi-squared|||Month 36: p-value was calculated using chi-square test.||||0.1085
71846818|NCT03365622|143208298|SUPERIORITY||Mean Difference (Final Values)|-0.333|STANDARD_ERROR_OF_MEAN|0.739||0.6527|TWO_SIDED|95.0|-1.792|1.125|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to first narcotic use, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.125|-1.792|0.6527
71846819|NCT03365622|143208299|SUPERIORITY||Odds Ratio (OR)|0.465||||0.0499|TWO_SIDED|95.0|0.217|1.0|||Regression, Logistic|Adjusted for age, sex, BMI, type of surgery and TAP block.||A logistic regression model was used to examine the association between treatment assignment and incidence of nausea, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||1.000|0.217|0.0499
71846820|NCT03365622|143208300|SUPERIORITY||Mean Difference (Final Values)|24.492|STANDARD_ERROR_OF_MEAN|18.165||0.179|TWO_SIDED|95.0|-11.321|60.304|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to discharge from PACU, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||60.304|-11.321|0.179
71846821|NCT03365622|143208301|SUPERIORITY||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.253||0.2811|TWO_SIDED|95.0|-0.226|0.773|||Regression, Linear|Adjusted for age, sex, BMI, type of surgery and TAP block.|"The estimate reflects the adjusted difference in mean outcome between arms/groups, with the placebo IV + oral acetaminophen serving as the reference group."|A multiple linear regression model was used to examine the association between treatment assignment and time to hospital discharge, adjusting for patient age, gender, body mass index (BMI), type of surgery (laparoscopic donor nephrectomy or laparoscopic nephrectomy for renal cancer), and whether the patient received a TAP block during surgery.||0.773|-0.226|0.2811
71846822|NCT04278833|143208302|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
71846823|NCT04278833|143208302|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||<0.001
71846824|NCT04278833|143208302|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||<0.001
71846825|NCT04278833|143208303|OTHER|||||||0.28||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at week 2||||0.280
71846826|NCT04278833|143208303|OTHER|||||||0.07||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 3||||0.070
71846827|NCT04278833|143208303|OTHER|||||||0.851||||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||Analysis of change at month 6||||0.851
71846828|NCT04278833|143208304|OTHER||||||<|0.001||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||<0.001
71846829|NCT04278833|143208304|OTHER|||||||0.021||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.021
71846830|NCT04278833|143208304|OTHER|||||||0.044||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.044
71898632|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.276||0.002|TWO_SIDED|95.0|-1.4|-0.31|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 29-32|||-0.31|-1.40|0.002
71898633|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.288||0.001|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 33-36|||-0.38|-1.51|0.001
71898634|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.287||0.008|TWO_SIDED|95.0|-1.32|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 37-40|||-0.20|-1.32|0.008
71846831|NCT04278833|143208305|OTHER|||||||0.226||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.226
71846832|NCT04278833|143208305|OTHER|||||||0.071||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3||||0.071
71846833|NCT04278833|143208305|OTHER|||||||0.382||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6||||0.382
71846834|NCT04278833|143208306|OTHER|||||||0.152||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at week 2||||0.152
71846835|NCT04278833|143208306|OTHER|||||||0.261||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 3.||||0.261
71846836|NCT04278833|143208306|OTHER|||||||0.437||||||The a priori threshold for statistical significance was \<0.05.|paired t-tests|||Analysis of change at month 6.||||0.437
71846837|NCT04278833|143208307|OTHER|||||||0.128||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.128
71846838|NCT04278833|143208307|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
71846839|NCT04278833|143208308|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||0.040
71846840|NCT04278833|143208308|OTHER||||||>|0.999||||||The a priori threshold for statistical significance was \<0.05.|Fisher Exact|||||||>0.999
71846841|NCT02609048|143208329|SUPERIORITY||Difference in LSM|-60.99|STANDARD_ERROR_OF_MEAN|5.814|<|0.0001|TWO_SIDED|95.0|-72.85|-49.13||Difference in mean,p-value, and CIs estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-49.13|-72.85|<0.0001
71898635|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.294||0.006|TWO_SIDED|95.0|-1.4|-0.24|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 41-44|||-0.24|-1.40|0.006
71678614|NCT03339726|142875489|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.266||0.97|TWO_SIDED|95.0|-0.54|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.54|0.970
71678615|NCT03339726|142875489|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.265||0.401|TWO_SIDED|95.0|-0.74|0.3||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.30|-0.74|0.401
71678616|NCT03339726|142875490|SUPERIORITY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.272||0.257|TWO_SIDED|95.0|-0.23|0.85||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.85|-0.23|0.257
71678617|NCT03339726|142875490|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.275||0.877|TWO_SIDED|95.0|-0.5|0.58||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.58|-0.50|0.877
71678618|NCT03339726|142875490|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.273||0.329|TWO_SIDED|95.0|-0.8|0.27||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.80|0.329
71678619|NCT03339726|142875491|SUPERIORITY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.298||0.469|TWO_SIDED|95.0|-0.37|0.8||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.80|-0.37|0.469
71678620|NCT03339726|142875491|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.301||0.924|TWO_SIDED|95.0|-0.57|0.62||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.62|-0.57|0.924
71815047|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.0472|TWO_SIDED||||||Chi-squared|||Month 48: p-value was calculated using chi-square test.||||0.0472
71815048|NCT01557322|143131567|SUPERIORITY_OR_OTHER|||||||0.4804|TWO_SIDED||||||Chi-squared|||Month 60: p-value was calculated using chi-square test.||||0.4804
71846842|NCT02609048|143208329|SUPERIORITY||Difference in Least Squares Mean (LSM)|-51.37|STANDARD_ERROR_OF_MEAN|5.849|<|0.0001|TWO_SIDED|95.0|-63.3|-39.44||Difference in mean,p-value, and confidence intervals (CIs) estimated by comparing Seladelpar level with placebo by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-39.44|-63.30|<0.0001
71846843|NCT02609048|143208329|SUPERIORITY||Difference in Least Squares Mean (LSM)|-9.62|STANDARD_ERROR_OF_MEAN|5.963||0.1167|TWO_SIDED|95.0|-21.79|2.54||Difference in mean,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor,baseline AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||2.54|-21.79|0.1167
71678621|NCT03339726|142875491|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.299||0.532|TWO_SIDED|95.0|-0.78|0.4||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.78|0.532
71678622|NCT03339726|142875492|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.309||0.579|TWO_SIDED|95.0|-0.78|0.44||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.44|-0.78|0.579
71678623|NCT03339726|142875492|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.312||0.394|TWO_SIDED|95.0|-0.88|0.35||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.35|-0.88|0.394
71678624|NCT03339726|142875492|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.31||0.76|TWO_SIDED|95.0|-0.71|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-0.71|0.760
71678625|NCT03339726|142875493|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.218||0.616|TWO_SIDED|95.0|-0.32|0.539||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.539|-0.320|0.616
71815049|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 6: p-value was calculated using chi-square test.||||0.0895
71815050|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0774|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 12: p-value was calculated using chi-square test.||||0.0774
71815051|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test.||||0.0024
71815052|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test.||||0.5552
71898636|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.299||0.004|TWO_SIDED|95.0|-1.44|-0.27|||Breathlessness score, Week 41-44||Breathlessness EXACT-RS score, Week 45-48|||-0.27|-1.44|0.004
71815053|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test.||||0.0793
71815054|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test.||||0.0075
71678626|NCT03339726|142875493|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.734|TWO_SIDED|95.0|-0.359|0.508||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.508|-0.359|0.734
71815055|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0895|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test.||||0.0895
71815056|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test.||||0.0024
71815057|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.6301|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test.||||0.6301
71846844|NCT02609048|143208330|SUPERIORITY||||||<|0.0001||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||<0.0001
71846845|NCT02609048|143208330|SUPERIORITY|||||||0.0036||||||The p-values were calculated from Fisher's exact test comparing each Seladelpar group with Placebo separately.|Fisher Exact|||||||0.0036
71846846|NCT02609048|143208330|SUPERIORITY|||||||0.1045||||||The p-values were calculated from Fisher's exact test comparing Seladelpar 200mg versus 50 mg.|Fisher Exact|||||||0.1045
71846847|NCT02609048|143208331|SUPERIORITY||Difference in LSM|234.71|STANDARD_ERROR_OF_MEAN|104.647||0.0322|TWO_SIDED|95.0|21.28|448.14||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||448.14|21.28|0.0322
71846848|NCT02609048|143208331|SUPERIORITY||Difference in LSM|132.82|STANDARD_ERROR_OF_MEAN|96.015||0.1764|TWO_SIDED|95.0|-63.0|328.65||Difference between means, p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate,and percent change from baseline in AST as response variable.|ANCOVA|||||328.65|-63.00|0.1764
71846849|NCT02609048|143208331|SUPERIORITY||Difference in LSM|101.88|STANDARD_ERROR_OF_MEAN|103.504||0.3326|TWO_SIDED|95.0|-109.21|312.98||Difference between means, p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline AST assessment as covariate, and percent change from baseline in AST as response variable.|ANCOVA|||||312.98|-109.21|0.3326
71846850|NCT02609048|143208332|SUPERIORITY||Difference in LSM|185.78|STANDARD_ERROR_OF_MEAN|104.379||0.0849|TWO_SIDED|95.0|-27.1|398.66||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline ALT assessment as covariate,and percent change from baseline in ALT as response variable.|ANCOVA|||||398.66|-27.10|0.0849
71846851|NCT02609048|143208332|SUPERIORITY||Difference in LSM|116.5|STANDARD_ERROR_OF_MEAN|97.437||0.2409|TWO_SIDED|95.0|-82.22|315.23||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||315.23|-82.22|0.2409
71815058|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0793|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test.||||0.0793
71815059|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||Chi-squared|||Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test.||||0.0075
71815060|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.7253|TWO_SIDED||||||Chi-squared|||Myeloma, Month 12: p-value was calculated using chi-square test.||||0.7253
71815061|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.7336|TWO_SIDED||||||Chi-squared|||Myeloma, Month 30: p-value was calculated using chi-square test.||||0.7336
71815062|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.0044|TWO_SIDED||||||Chi-squared|||Leukaemia, Month 12: p-value was calculated using chi-square test.||||0.0044
71815063|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.4175|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test.||||0.4175
71815064|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.3886|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test.||||0.3886
71815065|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.5102|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test.||||0.5102
71815066|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.9855|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test.||||0.9855
71846852|NCT02609048|143208332|SUPERIORITY||Difference in LSM|69.28|STANDARD_ERROR_OF_MEAN|105.295||0.5154|TWO_SIDED|95.0|-145.47|284.03||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline ALT assessment as covariate, and percent change from baseline in ALT as response variable.|ANCOVA|||||284.03|-145.47|0.5154
71846853|NCT02609048|143208333|SUPERIORITY||Difference in LSM|-45.34|STANDARD_ERROR_OF_MEAN|12.112||0.0007|TWO_SIDED|95.0|-70.04|-20.64||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-20.64|-70.04|0.0007
71846854|NCT02609048|143208333|SUPERIORITY||Difference in LSM|-40.78|STANDARD_ERROR_OF_MEAN|11.033||0.0008|TWO_SIDED|95.0|-63.28|-18.28||Difference between means, p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||-18.28|-63.28|0.0008
71846855|NCT02609048|143208333|SUPERIORITY||Difference in LSM|-4.56|STANDARD_ERROR_OF_MEAN|12.401||0.7155|TWO_SIDED|95.0|-29.85|20.73||Difference between means, p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline GGT assessment as covariate,and percent change from baseline in GGT as response variable.|ANCOVA|||||20.73|-29.85|0.7155
71846856|NCT02609048|143208334|SUPERIORITY||Difference in LSM|-34.27|STANDARD_ERROR_OF_MEAN|11.342||0.005|TWO_SIDED|95.0|-57.4|-11.14||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-11.14|-57.40|0.0050
71898637|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.294||0.003|TWO_SIDED|95.0|-1.45|-0.3|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 49-52EXA|||-0.30|-1.45|0.003
71898638|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.091||0.84|TWO_SIDED|95.0|-0.2|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 1-4|||0.16|-0.20|0.840
71898639|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.106||0.167|TWO_SIDED|95.0|-0.36|-0.06|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 5-8|||-0.06|-0.36|0.167
71898640|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.117||0.359|TWO_SIDED|95.0|-0.34|0.12|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 9-12|||0.12|-0.34|0.359
71898641|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.124||0.36|TWO_SIDED|95.0|-0.36|0.13|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 13-16|||0.13|-0.36|0.360
71898642|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.49|TWO_SIDED|95.0|-0.36|0.17|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 17-20|||0.17|-0.36|0.490
71898643|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.138||0.388|TWO_SIDED|95.0|-0.39|0.15|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 21-24|||0.15|-0.39|0.388
71898644|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.137||0.218|TWO_SIDED|95.0|-0.44|0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 25-28|||0.10|-0.44|0.218
71898645|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.138|TWO_SIDED|95.0|-0.47|0.07|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 29-32|||0.07|-0.47|0.138
71898646|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.239|TWO_SIDED|95.0|-0.44|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 33-36|||0.11|-0.44|0.239
71898647|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.138||0.417|TWO_SIDED|95.0|-0.38|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 37-40|||0.16|-0.38|0.417
71898648|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.144||0.078|TWO_SIDED|95.0|-0.54|0.03|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 41-44|||0.03|-0.54|0.078
71898649|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.14||0.058|TWO_SIDED|95.0|-0.54|0.01|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 45-48|||0.01|-0.54|0.058
71898650|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.141||0.231|TWO_SIDED|95.0|-0.45|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 49-52|||0.11|-0.45|0.231
71898651|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.097||0.068|TWO_SIDED|95.0|-0.37|0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 1-4|||0.01|-0.37|0.068
71898652|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.118||0.006|TWO_SIDED|95.0|-0.56|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 5-8|||-0.09|-0.56|0.006
71898653|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.131||0.042|TWO_SIDED|95.0|-0.53|-0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 9-12|||-0.01|-0.53|0.042
71898654|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.136||0.027|TWO_SIDED|95.0|-0.57|-0.03|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 13-16|||-0.03|-0.57|0.027
71898655|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.146||0.01|TWO_SIDED|95.0|-0.67|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 17-20|||-0.09|-0.67|0.010
71898656|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.144||0.01|TWO_SIDED|95.0|-0.66|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 21-24|||-0.09|-0.66|0.010
71898657|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|-0.7|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 25-28|||-0.12|-0.70|
71898658|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.152||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 29-32|||-0.09|-0.68|0.011
71898659|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.157||0.011|TWO_SIDED|95.0|-0.71|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 33-36|||-0.09|-0.71|0.011
71898660|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.151||0.014|TWO_SIDED|95.0|-0.67|-0.07|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 37-40|||-0.07|-0.67|0.014
71898661|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.153||0.007|TWO_SIDED|95.0|-0.72|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 41-44|||-0.12|-0.72|0.007
71898662|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.006|TWO_SIDED|95.0|-0.76|-0.13|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 45-48|||-0.13|-0.76|0.006
71898663|NCT02345161|143320730|SUPERIORITY_OR_OTHER||LS Mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.163||0.013|TWO_SIDED|95.0|-0.73|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 49-52|||-0.09|-0.73|0.013
71898664|NCT02345161|143320739|SUPERIORITY_OR_OTHER||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|0.81||0.023|TWO_SIDED|95.0|0.3|3.4|||Mixed Model Repeated Measures||For QTcF|||3.4|0.3|0.023
71815067|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.4955|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test.||||0.4955
71898665|NCT02345161|143320739|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.78||0.471|TWO_SIDED|95.0|-2.1|1.0|||Mixed Model Repeated Measures||For PR interval|||1.0|-2.1|0.471
71898666|NCT02345161|143320740|SUPERIORITY_OR_OTHER||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.83||0.564|TWO_SIDED|95.0|-4.7|2.5|||Mixed Model Repeated Measures||For QTcF|||2.5|-4.7|0.564
71898667|NCT02345161|143320740|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.57||0.908|TWO_SIDED|95.0|-2.9|3.3|||Mixed Model Repeated Measures||For PR interval|||3.3|-2.9|0.908
71898668|NCT02345161|143320743|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.849|TWO_SIDED|95.0|-1.0|1.2|||Mixed Model Repeated Measures||Week 24, SBP|||1.2|-1.0|0.849
71898669|NCT02345161|143320743|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.613|TWO_SIDED|95.0|-0.6|0.9|||Mixed Model Repeated Measures||Week 24, DBP|||0.9|-0.6|0.613
71898670|NCT02345161|143320744|SUPERIORITY_OR_OTHER||: LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.19||0.183|TWO_SIDED|95.0|-3.9|0.8|||Mixed Model Repeated Measures||Week 52, SBP|||0.8|-3.9|0.183
71898671|NCT02345161|143320744|SUPERIORITY_OR_OTHER||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.75||0.253|TWO_SIDED|95.0|-2.3|0.6|||Mixed Model Repeated Measures||Week 52, DBP|||0.6|-2.3|0.253
71898672|NCT02345161|143320746|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.526|TWO_SIDED|95.0|-0.6|1.2|||Mixed Model Repeated Measures|||||1.2|-0.6|0.526
71898673|NCT02345161|143320747|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.96||0.007|TWO_SIDED|95.0|0.7|4.5|||Mixed Model Repeated Measures|||||4.5|0.7|0.007
71898674|NCT01505491|143320773|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|113.22|STANDARD_ERROR_OF_MEAN|1.086||0.1163|TWO_SIDED|90.0|98.752|129.812|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||129.812|98.752|0.1163
71898675|NCT01505491|143320773|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|132.24|STANDARD_ERROR_OF_MEAN|1.094||0.7345|TWO_SIDED|90.0|113.984|153.412|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||153.412|113.984|0.7345
71815068|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.5404|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test.||||0.5404
71815069|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.3581|TWO_SIDED||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test.||||0.3581
71815070|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.4932|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 6: p-value was calculated using chi-square test.||||0.4932
71898676|NCT01505491|143320773|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.51|STANDARD_ERROR_OF_MEAN|1.09||0.1833|TWO_SIDED|90.0|74.974|99.83|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||99.830|74.974|0.1833
71898677|NCT01505491|143320774|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|109.42|STANDARD_ERROR_OF_MEAN|1.073||0.0303|TWO_SIDED|90.0|97.384|122.935|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.935|97.384|0.0303
71898678|NCT01505491|143320774|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|128.88|STANDARD_ERROR_OF_MEAN|1.08||0.6547|TWO_SIDED|90.0|113.492|146.365|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||146.365|113.492|0.6547
71898679|NCT01505491|143320774|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.24|STANDARD_ERROR_OF_MEAN|1.077||0.1572|TWO_SIDED|90.0|76.238|97.564|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||97.564|76.238|0.1572
71815071|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.4818|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 12: p-value was calculated using chi-square test.||||0.4818
71898680|NCT01505491|143320775|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|110.3|STANDARD_ERROR_OF_MEAN|1.063||0.0212|TWO_SIDED|90.0|99.687|122.035|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||122.035|99.687|0.0212
71898681|NCT01505491|143320775|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|117.53|STANDARD_ERROR_OF_MEAN|1.066||0.17|TWO_SIDED|90.0|105.638|130.757|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||130.757|105.638|0.1700
71815072|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.3224|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 18: p-value was calculated using chi-square test.||||0.3224
71815073|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.5003|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 24: p-value was calculated using chi-square test.||||0.5003
71815074|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.1134|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 30: p-value was calculated using chi-square test.||||0.1134
71815075|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.3488|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 36: p-value was calculated using chi-square test.||||0.3488
71815076|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.187|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 48: p-value was calculated using chi-square test.||||0.1870
71815077|NCT01557322|143131568|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Chi-squared|||Solid Tumor, Month 60: p-value was calculated using chi-square test.||||0.4270
71815078|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.5817|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 6: p-value was calculated using chi-square test.||||0.5817
71815079|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.2595|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 12: p-value was calculated using chi-square test.||||0.2595
71898682|NCT01505491|143320775|EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|96.53|STANDARD_ERROR_OF_MEAN|1.064||0.0016|TWO_SIDED|90.0|87.064|107.017|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.||107.017|87.064|0.0016
71815080|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.5642|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 18: p-value was calculated using chi-square test.||||0.5642
71898683|NCT02759146|143320778|SUPERIORITY||Difference between least squared means|0.09||||0.72|TWO_SIDED|95.0|-0.36|0.52||Adjusted for baseline and balancing factors used in the randomization|Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||.52|-.36|.72
71898684|NCT02759146|143320778|SUPERIORITY||Difference between least squared means|-0.15||||0.58|TWO_SIDED|95.0|-0.72|0.41|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||.41|-.72|.58
71815081|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 24: p-value was calculated using chi-square test.||||0.0034
71846857|NCT02609048|143208334|SUPERIORITY||Difference in LSM|-24.84|STANDARD_ERROR_OF_MEAN|10.116||0.0199|TWO_SIDED|95.0|-45.47|-4.21||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||-4.21|-45.47|0.0199
71846858|NCT02609048|143208334|SUPERIORITY||Difference in LSM|-9.43|STANDARD_ERROR_OF_MEAN|11.442||0.4161|TWO_SIDED|95.0|-32.77|13.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor, baseline 5NT assessment as covariate,and percent change from baseline in 5NT as response variable.|ANCOVA|||||13.90|-32.77|0.4161
71846859|NCT02609048|143208335|SUPERIORITY||Difference in LSM|6.2|STANDARD_ERROR_OF_MEAN|8.626||0.478|TWO_SIDED|95.0|-11.4|23.79||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||23.79|-11.40|0.4780
71846860|NCT02609048|143208335|SUPERIORITY||Difference in LSM|-12.0|STANDARD_ERROR_OF_MEAN|8.043||0.1459|TWO_SIDED|95.0|-28.4|4.41||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||4.41|-28.40|0.1459
71846861|NCT02609048|143208335|SUPERIORITY||Difference in LSM|18.19|STANDARD_ERROR_OF_MEAN|8.521||0.0407|TWO_SIDED|95.0|0.82|35.57||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg by ANCOVA model.Treatment group as factor, baseline assessment as covariate, and percent change from baseline in total bilirubin as response variable.|ANCOVA|||||35.57|0.82|0.0407
71846862|NCT02609048|143208336|SUPERIORITY||Difference in LSM|31.47|STANDARD_ERROR_OF_MEAN|13.831||0.03|TWO_SIDED|95.0|3.26|59.67||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||59.67|3.26|0.0300
71846863|NCT02609048|143208336|SUPERIORITY||Difference in LSM|-8.84|STANDARD_ERROR_OF_MEAN|12.883||0.4979|TWO_SIDED|95.0|-35.11|17.44||Difference between means,p-value,and CIs are estimated by each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||17.44|-35.11|0.4979
71846864|NCT02609048|143208336|SUPERIORITY||Difference in LSM|40.3|STANDARD_ERROR_OF_MEAN|13.591||0.0058|TWO_SIDED|95.0|12.58|68.02||Difference between means,p-value,and CIs are estimated for Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline assessment as covariate,and percent change from baseline in conjugated bilirubin as response variable.|ANCOVA|||||68.02|12.58|0.0058
71846865|NCT02609048|143208337|SUPERIORITY||Difference in LSM|-2.97|STANDARD_ERROR_OF_MEAN|8.362||0.7244|TWO_SIDED|95.0|-20.03|14.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||14.08|-20.03|0.7244
71846866|NCT02609048|143208337|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|7.819||0.08|TWO_SIDED|95.0|-30.1|1.8||Difference between means,p-value, and CIs are estimated by comparing Seladelpar level with placebo using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||1.80|-30.10|0.0800
71846867|NCT02609048|143208337|SUPERIORITY||Difference in LSM|11.18|STANDARD_ERROR_OF_MEAN|8.29||0.1874|TWO_SIDED|95.0|-5.73|28.08||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as a factor,baseline assessment as covariate, and percent change from baseline as the response variable.|ANCOVA|||||28.08|-5.73|0.1874
71898685|NCT02759146|143320778|SUPERIORITY||Difference between least squared means|-0.24||||0.42|TWO_SIDED|95.0|-0.81|0.34|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||.34|-.81|.42
71815082|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.7137|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 36: p-value was calculated using chi-square test.||||0.7137
71898686|NCT02759146|143320779|SUPERIORITY||Difference between least squared means|-0.01||||0.96|TWO_SIDED|95.0|-0.44|0.42|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.42|-0.44|0.96
71815083|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.963|TWO_SIDED||||||Chi-squared|||Death Due to AE, Month 60: p-value was calculated using chi-square test.||||0.9630
71815084|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.7353|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test.||||0.7353
71815085|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.3829|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test.||||0.3829
71678627|NCT03339726|142875493|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.218||0.874|TWO_SIDED|95.0|-0.465|0.395||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.395|-0.465|0.874
71678628|NCT03339726|142875494|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.23||0.75|TWO_SIDED|95.0|-0.53|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.53|0.750
71815086|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.4532|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test.||||0.4532
71815087|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.4238|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test.||||0.4238
71815088|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.1218|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test.||||0.1218
71815089|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.4124|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test.||||0.4124
71815090|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.6356|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test.||||0.6356
71815091|NCT01557322|143131569|SUPERIORITY_OR_OTHER|||||||0.5491|TWO_SIDED||||||Chi-squared|||Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test.||||0.5491
71815092|NCT01557322|143131570|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
71815093|NCT01557322|143131571|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline HAQ-DI score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||<0.0001
71846868|NCT02609048|143208338|SUPERIORITY||Difference in LSM|-45.96|STANDARD_ERROR_OF_MEAN|6.638|<|0.0001|TWO_SIDED|95.0|-59.5|-32.42||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-32.42|-59.50|<0.0001
71846869|NCT02609048|143208338|SUPERIORITY||Difference in LSM|-34.66|STANDARD_ERROR_OF_MEAN|6.46|<|0.0001|TWO_SIDED|95.0|-47.83|-21.48||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||-21.48|-47.83|<0.0001
71678629|NCT03339726|142875494|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.232||0.39|TWO_SIDED|95.0|-0.26|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.26|0.390
71678630|NCT03339726|142875494|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.23||0.236|TWO_SIDED|95.0|-0.18|0.73||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.73|-0.18|0.236
71815094|NCT01557322|143131572|SUPERIORITY_OR_OTHER|||||||0.2558|TWO_SIDED||||||Regression, Linear|||PCS: p-value was calculated using multivariate linear regression with baseline PCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.2558
71815095|NCT01557322|143131572|SUPERIORITY_OR_OTHER|||||||0.4908|TWO_SIDED||||||Regression, Linear|||MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.4908
71815096|NCT01557322|143131572|SUPERIORITY_OR_OTHER|||||||0.8379|TWO_SIDED||||||Regression, Linear|||Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.||||0.8379
71815097|NCT02247336|143131574|SUPERIORITY||Odds Ratio (OR)|0.7||||0.16|TWO_SIDED|95.0|0.4|1.2||A priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|Using alpha=0.05, 80% power, and a risk-appropriate screening referral rate for the delayed arm ranging from 60% to 70%, n = 250 participants with a completed a family health history assessment per arm with 40 providers was needed to detect differences between arms in appropriate referral ranging from 12% to 13.2%. Sample size calculations accounted for provider clustering using an intra-class correlation coefficient of 0.02 to adjust variance for a Z-test of the difference of two proportions.||1.2|0.4|0.16
71815098|NCT02247336|143131575|SUPERIORITY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.04|1.2||The a priori threshold was 0.05.|Regression, Logistic|generalized estimating equation|Generalized estimating equation models were used with a logit link function and an exchangeable correlation structure to account for clustering of participants within provider. Fay and Graubard small sample bias correction was applied.|||1.2|.04|0.23
71815099|NCT00947661|143131588|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was \<1.5, and upper limit of 95% CI was \<1 at most (at least 7 of 12) time point.|||||<|0.01|TWO_SIDED||||||ANCOVA|||||||<0.01
71815100|NCT02552238|143131590|SUPERIORITY|||||||0.0067|||||||McNemar|||Sensitivity: superiority test comparing CE-DSE and UE-DSE based on the difference||||0.0067
71815101|NCT02552238|143131590|SUPERIORITY||||||<|0.0001|||||||McNemar|||Specificity: superiority test comparing CE-DSE and UE-DSE based on the difference||||<0.0001
71815102|NCT02036645|143131607|SUPERIORITY_OR_OTHER||Slope|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.04|0.82|
71815103|NCT02036645|143131607|SUPERIORITY_OR_OTHER||Slope|1.01|||||TWO_SIDED|95.0|0.71|1.3|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.30|0.71|
71815104|NCT02036645|143131608|SUPERIORITY_OR_OTHER||Slope|0.9|||||TWO_SIDED|95.0|0.81|0.98|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||0.98|0.81|
71815105|NCT02036645|143131608|SUPERIORITY_OR_OTHER||Slope|0.96|||||TWO_SIDED|95.0|0.65|1.27|||Regression, Linear||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated|||1.27|0.65|
71815106|NCT01986101|143131614|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.007|TWO_SIDED|95.0|-4.9|-1.0||Hochberg-adjusted|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-1.0|-4.9|0.007
71815107|NCT01986101|143131614|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|1.03||0.057|TWO_SIDED|95.0|-4.0|0.1||Hochberg-adjusted.|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.1|-4.0|0.057
71815108|NCT01986101|143131615|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.127||0.002|TWO_SIDED|95.0|-0.65|-0.15|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.15|-0.65|0.002
71815109|NCT01986101|143131615|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13||0.019|TWO_SIDED|95.0|-0.56|-0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group.|||-0.05|-0.56|0.019
71815110|NCT01986101|143131616|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|0.89||0.037|TWO_SIDED|95.0|-3.6|-0.1|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.1|-3.6|0.037
71815111|NCT01986101|143131616|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.92||0.223|TWO_SIDED|95.0|-2.9|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.9|0.223
71815112|NCT01986101|143131617|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.262||0.076|TWO_SIDED|95.0|-0.98|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-0.98|0.076
71815113|NCT01986101|143131617|SUPERIORITY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.269||0.075|TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.05|-1.01|0.075
71815114|NCT01986101|143131618|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.016|TWO_SIDED|95.0|-3.1|-0.3|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||-0.3|-3.1|0.016
71815115|NCT01986101|143131618|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.71||0.294|TWO_SIDED|95.0|-2.1|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.|||0.7|-2.1|0.294
71815116|NCT02404389|143131623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.515|TWO_SIDED|90.0|-0.12|0.12|||Posterior mean|||||0.12|-0.12|0.515
71815117|NCT02404389|143131623|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p value is provided|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.07||0.517|TWO_SIDED|90.0|-0.12|0.13|||posterior mean|||||0.13|-0.12|0.517
71815118|NCT03324880|143131629|SUPERIORITY||Difference in Least Squares (LS) Mean|-0.53|STANDARD_ERROR_OF_MEAN|0.189|=|0.003|TWO_SIDED|95.0|-0.9|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom subscale score.|-0.15|-0.90|=0.003
71815119|NCT03324880|143131630|SUPERIORITY||Difference in LS Mean|10.5|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|5.1|15.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACIT-Fatigue total score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACIT-Fatigue total score.|15.9|5.1|<0.001
71815120|NCT03324880|143131631|SUPERIORITY||Difference in LS Mean|4.242|STANDARD_ERROR_OF_MEAN|1.9219|=|0.015|TWO_SIDED|95.0|0.413|8.072||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 PCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 PCS score.|8.072|0.413|=0.015
71815121|NCT03324880|143131632|SUPERIORITY||Difference in LS Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.112|=|0.002|TWO_SIDED|95.0|-0.55|-0.1||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact subscale score.|-0.10|-0.55|=0.002
71815122|NCT03324880|143131633|SUPERIORITY||Difference in LS Mean|-0.28|STANDARD_ERROR_OF_MEAN|0.125|=|0.013|TWO_SIDED|95.0|-0.53|-0.04||1-sided p-value was reported.|MMRM|||Impact on Sleep|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.04|-0.53|=0.013
71678631|NCT03339726|142875495|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.267||0.707|TWO_SIDED|95.0|-0.63|0.43||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.63|0.707
71815123|NCT03324880|143131633|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.128|=|0.003|TWO_SIDED|95.0|-0.61|-0.11||1-sided p-value was reported.|MMRM|||Ability to Exercise|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.11|-0.61|=0.003
71815124|NCT03324880|143131633|SUPERIORITY||Difference in LS Mean|-0.36|STANDARD_ERROR_OF_MEAN|0.123|=|0.002|TWO_SIDED|95.0|-0.61|-0.12||1-sided p-value was reported.|MMRM|||Ability to Complete Work|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.12|-0.61|=0.002
71815125|NCT03324880|143131633|SUPERIORITY||Difference in LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.121|=|0.002|TWO_SIDED|95.0|-0.61|-0.13||1-sided p-value was reported.|MMRM|||Impact Family Relationships|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD impact item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD impact item score.|-0.13|-0.61|=0.002
71815126|NCT03324880|143131634|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.203|=|0.004|TWO_SIDED|95.0|-0.96|-0.15||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD anxiety item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD anxiety item score.|-0.15|-0.96|=0.004
71815127|NCT03324880|143131635|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.2|=|0.004|TWO_SIDED|95.0|-0.93|-0.14||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD sadness or depression item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD sadness or depression item score.|-0.14|-0.93|=0.004
71815128|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.56|STANDARD_ERROR_OF_MEAN|0.218|=|0.006|TWO_SIDED|95.0|-0.99|-0.12||1-sided p-value was reported.|MMRM|||Muscle Cramps|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.99|=0.006
71815129|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.54|STANDARD_ERROR_OF_MEAN|0.213|=|0.007|TWO_SIDED|95.0|-0.96|-0.12||1-sided p-value was reported.|MMRM|||Tingling|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.12|-0.96|=0.007
71815130|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.48|STANDARD_ERROR_OF_MEAN|0.231|=|0.02|TWO_SIDED|95.0|-0.94|-0.02||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.02|-0.94|=0.020
71815131|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.219|=|0.003|TWO_SIDED|95.0|-1.05|-0.18||1-sided p-value was reported.|MMRM|||Muscle Spasms|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.18|-1.05|=0.003
71815132|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.38|STANDARD_ERROR_OF_MEAN|0.229|=|0.05|TWO_SIDED|95.0|-0.83|0.07||1-sided p-value was reported.|MMRM|||Feelings of Heaviness|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|0.07|-0.83|=0.050
71815133|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.55|STANDARD_ERROR_OF_MEAN|0.227|=|0.008|TWO_SIDED|95.0|-1.01|-0.1||1-sided p-value was reported.|MMRM|||Physical Fatigue|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.10|-1.01|=0.008
71815134|NCT03324880|143131636|SUPERIORITY||Difference in LS Mean|-0.51|STANDARD_ERROR_OF_MEAN|0.186|=|0.004|TWO_SIDED|95.0|-0.87|-0.14||1-sided p-value was reported.|MMRM|||Brain Fog|MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD symptom item score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD symptom item score.|-0.14|-0.87|=0.004
71815135|NCT03324880|143131638|SUPERIORITY||Difference in LS Mean|-0.9|STANDARD_ERROR_OF_MEAN|0.235|<|0.001|TWO_SIDED|95.0|-1.37|-0.43||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in HypoPT-SD most bothersome symptom score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect, with adjustment for baseline HypoPT-SD most bothersome symptom score.|-0.43|-1.37|<0.001
71898687|NCT02759146|143320779|SUPERIORITY||Difference between least squared means|-0.2||||0.48|TWO_SIDED|95.0|-0.75|0.35|||Mixed Models Analysis||Difference between reflexology and control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.35|-0.75|0.48
71898688|NCT02759146|143320779|SUPERIORITY||Difference between least squared means|-0.19||||0.52|TWO_SIDED|95.0|-0.75|0.38|||Mixed Models Analysis||Difference between meditative practice and control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||0.38|-0.75|0.52
71815136|NCT03324880|143131639|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog Perceived Cognitive Impairments Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog Perceived Cognitive Impairments Subscale score.|4.3|0.0|=0.024
71815137|NCT03324880|143131640|SUPERIORITY||Difference in LS Mean|2.1|STANDARD_ERROR_OF_MEAN|1.07|=|0.024|TWO_SIDED|95.0|0.0|4.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in FACT-Cog QoL Subscale score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline FACT-Cog QoL Subscale score.|4.3|0.0|=0.024
71815138|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|7.21|STANDARD_ERROR_OF_MEAN|2.1376|=|0.001|TWO_SIDED|95.0|2.951|11.469||1-sided p-value was reported.|MMRM|||Standard-Bodily Pain|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|11.469|2.951|=0.001
71815139|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|5.545|STANDARD_ERROR_OF_MEAN|2.0542|=|0.004|TWO_SIDED|95.0|1.452|9.638||1-sided p-value was reported.|MMRM|||Standard-General Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.638|1.452|=0.004
71898689|NCT02759146|143320780|SUPERIORITY||Difference between least squared means|0.67||||0.68|TWO_SIDED|95.0|-2.52|3.86|||Mixed Models Analysis||Comparing reflexology to meditative practices for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||3.86|-2.52|.68
71898690|NCT02759146|143320780|SUPERIORITY||Difference between least squared means|-2.53||||0.23|TWO_SIDED|95.0|-6.64|1.58|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||1.58|-6.64|.23
71678632|NCT03339726|142875495|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.269||0.839|TWO_SIDED|95.0|-0.59|0.48||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.48|-0.59|0.839
71815140|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|7.857|STANDARD_ERROR_OF_MEAN|2.2913|<|0.001|TWO_SIDED|95.0|3.292|12.423||1-sided p-value was reported.|MMRM|||Standard-Mental Health|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.423|3.292|<0.001
71815141|NCT03324880|143131641|SUPERIORITY||MMRM|4.554|STANDARD_ERROR_OF_MEAN|2.1123|=|0.017|TWO_SIDED|95.0|0.345|8.763||1-sided p-value was reported.|MMRM|||Standard-Physical Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.763|0.345|=0.017
71815142|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|8.42|STANDARD_ERROR_OF_MEAN|2.3186|<|0.001|TWO_SIDED|95.0|3.8|13.04||1-sided p-value was reported.|MMRM|||Standard-Role-Emotional|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|13.040|3.800|<0.001
71815143|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|4.23|STANDARD_ERROR_OF_MEAN|2.2489|=|0.032|TWO_SIDED|95.0|-0.251|8.711||1-sided p-value was reported.|MMRM|||Standard-Role-Physical|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|8.711|-0.251|=0.032
71898691|NCT02759146|143320780|SUPERIORITY||Difference between least squared means|-3.2||||0.14|TWO_SIDED|95.0|-7.41|1.01|||Mixed Models Analysis||Comparing meditative practice to control for weeks 1-4|Aim 1: Comparing meditative practice vs control for weeks 1-4||1.01|-7.41|0.14
71678633|NCT03339726|142875495|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.267||0.864|TWO_SIDED|95.0|-0.48|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.48|0.864
71815144|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|3.809|STANDARD_ERROR_OF_MEAN|2.6658|=|0.079|TWO_SIDED|95.0|-1.502|9.121||1-sided p-value was reported.|MMRM|||Standard-Social Functioning|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|9.121|-1.502|=0.079
71815145|NCT03324880|143131641|SUPERIORITY||Difference in LS Mean|7.942|STANDARD_ERROR_OF_MEAN|2.353|=|0.001|TWO_SIDED|95.0|3.253|12.63||1-sided p-value was reported.|MMRM|||Standard-Vitality|MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 domain score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 domain score.|12.630|3.253|=0.001
71815146|NCT03324880|143131642|SUPERIORITY||Difference in LS Mean|8.3|STANDARD_ERROR_OF_MEAN|2.2642|<|0.001|TWO_SIDED|95.0|3.788|12.811||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in SF-36 MCS score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline SF-36 MCS score.|12.811|3.788|<0.001
71898692|NCT02759146|143320781|SUPERIORITY||Difference between least squared means|0.01||||0.98|TWO_SIDED|95.0|-0.38|0.39|||Mixed Models Analysis||Difference between reflexology and meditative practice for weeks 1-4|Aim 1: Comparing reflexology vs meditative practice for weeks 1-4||0.39|-0.38|0.98
71898693|NCT02759146|143320781|SUPERIORITY||Difference between least squared means|-0.24||||0.34|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis||Comparing reflexology to control for weeks 1-4|Aim 1: Comparing reflexology vs control for weeks 1-4||0.25|-0.74|0.34
71815147|NCT03324880|143131643|SUPERIORITY||Difference in LS Mean|3.13|STANDARD_ERROR_OF_MEAN|9.578|=|0.627|TWO_SIDED|95.0|-16.33|22.6||1-sided p-value was reported.|MMRM|||Percent Work Time Missed Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|22.60|-16.33|=0.627
71815148|NCT03324880|143131643|SUPERIORITY||Difference in LS Mean|-14.6|STANDARD_ERROR_OF_MEAN|7.52|=|0.031|TWO_SIDED|95.0|-29.9|0.7||1-sided p-value was reported.|MMRM|||Percent Impairment While Working Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|0.7|-29.9|=0.031
71815149|NCT03324880|143131643|SUPERIORITY||Difference in LS Mean|-14.9|STANDARD_ERROR_OF_MEAN|6.146|=|0.011|TWO_SIDED|95.0|-27.42|-2.39||1-sided p-value was reported.|MMRM|||Percent Overall Work Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-2.39|-27.42|=0.011
71815150|NCT03324880|143131643|SUPERIORITY||Difference in LS Mean|-13.0|STANDARD_ERROR_OF_MEAN|5.78|=|0.014|TWO_SIDED|95.0|-24.5|-1.5||1-sided p-value was reported.|MMRM|||Percent Activity Impairment Due to Problem|MMRM analysis over all post-baseline visits, with the change from baseline in WPAI score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline WPAI score.|-1.5|-24.5|=0.014
71815151|NCT03324880|143131644|SUPERIORITY||Difference in LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.22|=|0.01|TWO_SIDED|95.0|-1.0|-0.1||1-sided p-value|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in PGI-S score as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline PGI-S score.|-0.1|-1.0|=0.010
71815152|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|0.01|||=|0.516|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|From an Analysis of Covariance (ANCOVA) with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Detection||0.05|-0.03|=0.516
71815153|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|0.02|||=|0.275|TWO_SIDED|95.0|-0.02|0.06|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Identification||0.06|-0.02|=0.275
71815154|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|0.01|||=|0.777|TWO_SIDED|95.0|-0.05|0.07|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Card Learning||0.07|-0.05|=0.777
71815155|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|0.01|||=|0.831|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||One Back (ONB)||0.05|-0.04|=0.831
71815156|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|9.93|||=|0.075|TWO_SIDED|95.0|-1.0|20.85|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||Groton Maze Learning (GML)||20.85|-1.00|=0.075
71815157|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|-0.57|||=|0.545|TWO_SIDED|95.0|-2.41|1.27|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List (ISL)||1.27|-2.41|=0.545
71815158|NCT03324880|143131646|SUPERIORITY||Difference in LS Mean|0.55|||=|0.283|TWO_SIDED|95.0|-0.45|1.56|||ANCOVA|From an ANCOVA with treatment group (rhPTH(l-84), placebo) as the predictor and Baseline score as a covariate.||International Shopping List Test Delayed Recall (ISRL)||1.56|-0.45|=0.283
71815159|NCT03324880|143131647|SUPERIORITY||Difference in LS Mean|0.01|||=|0.582|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Detection (DET)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.582
71846870|NCT02609048|143208338|SUPERIORITY||Difference in LSM|-11.3|STANDARD_ERROR_OF_MEAN|6.508||0.0924|TWO_SIDED|95.0|-24.58|1.97||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline bone-specific AP assessment as covariate,and percent change from baseline as response variable.|ANCOVA|||||1.97|-24.58|0.0924
71846871|NCT02609048|143208339|SUPERIORITY||Difference in LSM|-14.15|STANDARD_ERROR_OF_MEAN|12.807||0.2777|TWO_SIDED|95.0|-40.27|11.97||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||11.97|-40.27|0.2777
71815160|NCT03324880|143131647|SUPERIORITY||Difference in LS Mean|0.01|||=|0.492|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||Identification (IDN)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.492
71815161|NCT03324880|143131647|SUPERIORITY||Difference in LS Mean|0.01|||=|0.506|TWO_SIDED|95.0|-0.03|0.06||1-sided p-value was reported.|MMRM|||One Card Learning (OCL)|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.06|-0.03|=0.506
71815162|NCT03324880|143131647|SUPERIORITY||Difference in LS Mean|0.01|||=|0.438|TWO_SIDED|95.0|-0.02|0.04||1-sided p-value was reported.|MMRM|||One Back Test|From MMRM with visit, treatment group, and visit treatment group as fixed effects, Baseline score as a covariate, and participant as a random effect. By-participant scores, which are summarized in this table, are derived as the average of the planned at-home assessment values that passed the Completion criteria over 14 days preceding the visit.|0.04|-0.02|=0.438
71898694|NCT02759146|143320781|SUPERIORITY||Difference between least squared means|-0.25||||0.34|TWO_SIDED|95.0|-0.76|0.26|||Mixed Models Analysis||Comparing meditative practices vs control for weeks 1-4|Aim 1: Comparing meditative practices vs control for weeks 1-4||0.26|-0.76|0.34
71846872|NCT02609048|143208339|SUPERIORITY||Difference in LSM|-37.31|STANDARD_ERROR_OF_MEAN|11.946||0.0039|TWO_SIDED|95.0|-61.67|-12.95||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||-12.95|-61.67|0.0039
71846873|NCT02609048|143208339|SUPERIORITY||Difference in LSM|23.16|STANDARD_ERROR_OF_MEAN|12.498||0.0734|TWO_SIDED|95.0|-2.33|48.65||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TG assessment as a covariate, and percent change from baseline in TG as response variable.|ANCOVA|||||48.65|-2.33|0.0734
71846874|NCT02609048|143208340|SUPERIORITY||Difference in LSM|-16.12|STANDARD_ERROR_OF_MEAN|4.433||0.001|TWO_SIDED|95.0|-25.16|-7.07||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||-7.07|-25.16|0.0010
71846875|NCT02609048|143208340|SUPERIORITY||Difference in LSM|-8.13|STANDARD_ERROR_OF_MEAN|3.992||0.0504|TWO_SIDED|95.0|-16.27|0.02||Difference between means,p-value,and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.02|-16.27|0.0504
71846876|NCT02609048|143208340|SUPERIORITY||Difference in LSM|-7.99|STANDARD_ERROR_OF_MEAN|4.317||0.0738|TWO_SIDED|95.0|-16.8|0.81||Difference between means,p-value,and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline TC assessment as covariate,and percent change from baseline in TC as the response variable.|ANCOVA|||||0.81|-16.80|0.0738
71846877|NCT02609048|143208341|SUPERIORITY||Difference in LSM|-17.39|STANDARD_ERROR_OF_MEAN|5.848||0.0057|TWO_SIDED|95.0|-29.32|-5.46||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-5.46|-29.32|0.0057
71678634|NCT03339726|142875496|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.255||0.794|TWO_SIDED|95.0|-0.44|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.44|0.794
71678635|NCT03339726|142875496|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.257||0.628|TWO_SIDED|95.0|-0.38|0.63||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.63|-0.38|0.628
71815163|NCT03324880|143131648|SUPERIORITY||Difference in LS Mean|2.09|STANDARD_ERROR_OF_MEAN|0.871|=|0.991|TWO_SIDED|95.0|0.36|3.83||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in 24-hour urine calcium excretion as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline 24-Hour urine calcium excretion.|3.83|0.36|=0.991
71815164|NCT03324880|143131649|SUPERIORITY||Difference in LS Mean|-0.175|STANDARD_ERROR_OF_MEAN|0.0395|<|0.001|TWO_SIDED|95.0|-0.254|-0.097||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in serum phosphate as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline serum phosphate.|-0.097|-0.254|<0.001
71846878|NCT02609048|143208341|SUPERIORITY||Difference in LSM|-0.89|STANDARD_ERROR_OF_MEAN|5.378||0.8703|TWO_SIDED|95.0|-11.85|10.08||Difference between means,p-value,and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||10.08|-11.85|0.8703
71846879|NCT02609048|143208341|SUPERIORITY||Difference in LSM|-16.51|STANDARD_ERROR_OF_MEAN|5.781||0.0076|TWO_SIDED|95.0|-28.3|-4.71||Difference between means,p-value,and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline HDL-C assessment as covariate,and percent change from baseline in HDL-C as response variable.|ANCOVA|||||-4.71|-28.30|0.0076
71846880|NCT02609048|143208342|SUPERIORITY||Difference in LSM|-14.85|STANDARD_ERROR_OF_MEAN|5.981||0.0186|TWO_SIDED|95.0|-27.05|-2.66||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||-2.66|-27.05|0.0186
71846881|NCT02609048|143208342|SUPERIORITY||Difference in LSM|-10.06|STANDARD_ERROR_OF_MEAN|5.448||0.0745|TWO_SIDED|95.0|-21.17|1.06||Difference between means,p-value, and CIs estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||1.06|-21.17|0.0745
71846882|NCT02609048|143208342|SUPERIORITY||Difference in LSM|-4.8|STANDARD_ERROR_OF_MEAN|5.785||0.4131|TWO_SIDED|95.0|-16.6|7.0||Difference between means,p-value, and CIs estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline LDL-C assessment as covariate,and percent change from baseline in LDL-C as response variable.|ANCOVA|||||7.00|-16.60|0.4131
71846883|NCT02609048|143208343|SUPERIORITY|||||||0.4667||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.4667
71846884|NCT02609048|143208343|SUPERIORITY|||||||0.4667||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.4667
71846885|NCT02609048|143208344|SUPERIORITY|||||||0.0824||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0824
71846886|NCT02609048|143208344|SUPERIORITY|||||||0.0537||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0537
71846887|NCT02609048|143208344|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
71846888|NCT02609048|143208345|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
71678636|NCT03339726|142875496|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.255||0.82|TWO_SIDED|95.0|-0.45|0.56||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.56|-0.45|0.820
71846889|NCT02609048|143208345|SUPERIORITY|||||||0.0198||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0198
71846890|NCT02609048|143208345|SUPERIORITY|||||||0.5165||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||0.5165
71846891|NCT02609048|143208346|SUPERIORITY|||||||0.0101||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0101
71846892|NCT02609048|143208346|SUPERIORITY|||||||0.0055||||||Fisher's exact test between each Seladelpar level compared with placebo was used to obtain the p-value.|Fisher Exact|||||||0.0055
71846893|NCT02609048|143208346|SUPERIORITY|||||||1||||||Fisher's exact test between Seladelpar 200 mg versus 50 mg was used to obtain the p-value.|Fisher Exact|||||||1.0000
71846894|NCT02609048|143208348|SUPERIORITY||Difference in LSM|-1.1|STANDARD_ERROR_OF_MEAN|1.82||0.5379|TWO_SIDED|95.0|-4.8|2.6||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.6|-4.8|0.5379
71846895|NCT02609048|143208348|SUPERIORITY||Difference in LSM|0.2|STANDARD_ERROR_OF_MEAN|1.7||0.8949|TWO_SIDED|95.0|-3.3|3.7||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||3.7|-3.3|0.8949
71846896|NCT02609048|143208348|SUPERIORITY||Difference in LSM|-1.4|STANDARD_ERROR_OF_MEAN|1.75||0.4431|TWO_SIDED|95.0|-4.9|2.2||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor, baseline score as covariate, and change from baseline score as the response variable.|ANCOVA|||||2.2|-4.9|0.4431
71846897|NCT02609048|143208349|SUPERIORITY||Difference in LSM|-7.4|STANDARD_ERROR_OF_MEAN|10.07||0.4674|TWO_SIDED|95.0|-28.0|13.2||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||13.2|-28.0|0.4674
71678637|NCT03339726|142875497|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.266||0.33|TWO_SIDED|95.0|-0.27|0.79||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.79|-0.27|0.330
71678638|NCT03339726|142875497|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.631|TWO_SIDED|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.66|-0.40|0.631
71678639|NCT03339726|142875497|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.266||0.625|TWO_SIDED|95.0|-0.66|0.4||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.40|-0.66|0.625
71678640|NCT03339726|142875498|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.275||0.24|TWO_SIDED|95.0|-0.22|0.87||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.87|-0.22|0.240
71678641|NCT03339726|142875498|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.278||0.865|TWO_SIDED|95.0|-0.5|0.6||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.60|-0.50|0.865
71678642|NCT03339726|142875498|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.275||0.316|TWO_SIDED|95.0|-0.82|0.27||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.27|-0.82|0.316
71898695|NCT02759146|143320782|SUPERIORITY||Difference between least squared means|0.25||||0.57|TWO_SIDED|95.0|-0.63|1.14|||Mixed Models Analysis||After the initial 4 weeks of reflexology, comparing continued reflexology to added meditative practice|Aim 2: After 4 weeks of reflexology, comparing continuing reflexology vs adding meditative practice||1.14|-.63|0.57
71678643|NCT03339726|142875499|SUPERIORITY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.284||0.529|TWO_SIDED|95.0|-0.38|0.74||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.74|-0.38|0.529
71678644|NCT03339726|142875499|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.287||0.997|TWO_SIDED|95.0|-0.56|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.56|0.997
71678645|NCT03339726|142875499|SUPERIORITY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.285||0.532|TWO_SIDED|95.0|-0.74|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.74|0.532
71678646|NCT03339726|142875500|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.309||0.468|TWO_SIDED|95.0|-0.83|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.83|0.468
71898696|NCT02759146|143320782|SUPERIORITY||Least Square (LS) Mean|0.49||||0.39|TWO_SIDED|95.0|-0.64|1.63|||Mixed Models Analysis||After the initial 4 weeks of meditative practices, comparing continuing meditative practice to adding reflexology|Aim 3: After 4 weeks of meditative practice, comparing continuing with meditative practice vs. adding reflexology for weeks 5-12||1.63|-0.64|0.39
71898697|NCT02759146|143320783|SUPERIORITY||Least Square (LS) Mean|1.94||||0.67|TWO_SIDED|95.0|-10.93|7.04|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||7.04|-10.93|0.67
71678647|NCT03339726|142875500|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.312||0.218|TWO_SIDED|95.0|-1.0|0.23||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.23|-1.00|0.218
71678648|NCT03339726|142875500|SUPERIORITY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.309||0.604|TWO_SIDED|95.0|-0.77|0.45||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.45|-0.77|0.604
71678649|NCT01246349|142875511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.616|STANDARD_ERROR_OF_MEAN|7.373||0.24|TWO_SIDED|95.0|-5.871|23.103|||Regression, Linear|||Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[WEL\] change between the treatment and control groups from baseline to a 6 month follow-up).||23.103|-5.871|0.24
71678650|NCT01246349|142875512|SUPERIORITY_OR_OTHER|||||||0.56|||||||Regression, Linear|||Results published comprise baseline and follow-up BMI z-score means and standard deviations for both the MI and control groups (reported above), as well as the attributable effect of intervention (i.e., the difference in BMI change between the treatment and control groups from baseline to a 6-month follow-up)||||0.56
71815165|NCT03324880|143131650|SUPERIORITY||Difference in LS Mean|4.08|STANDARD_ERROR_OF_MEAN|4.654|=|0.81|TWO_SIDED|95.0|-5.06|13.22||1-sided p-value was reported.|MMRM||||From a mixed-effects model for repeated measures (MMRM) analysis over all post-baseline visits, with the change from baseline in active vitamin D supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline active vitamin D supplement dose.|13.22|-5.06|=0.810
71815166|NCT03324880|143131651|SUPERIORITY||Difference in LS Mean|-331.3|STANDARD_ERROR_OF_MEAN|132.56|=|0.007|TWO_SIDED|95.0|-594.6|-67.9||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in elemental calcium supplement dose as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline elemental calcium supplement dose.|-67.9|-594.6|=0.007
71815167|NCT03324880|143131654|SUPERIORITY||Difference in LS Mean|22.33|STANDARD_ERROR_OF_MEAN|3.271|<|0.001|TWO_SIDED|95.0|15.83|28.84||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|28.84|15.83|<0.001
71815168|NCT03324880|143131655|SUPERIORITY||Difference in LS Mean|785.5|STANDARD_ERROR_OF_MEAN|113.65|<|0.001|TWO_SIDED|95.0|559.6|1011.3||1-sided p-value was reported.|MMRM||||MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|1011.3|559.6|<0.001
71815169|NCT03324880|143131656|SUPERIORITY||Difference in LS Mean|56.43|STANDARD_ERROR_OF_MEAN|6.091|<|0.001|TWO_SIDED|95.0|44.33|68.53||1-sided p-value was reported.|MMRM|||Osteocalcin|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|68.53|44.33|<0.001
71815170|NCT03324880|143131656|SUPERIORITY||Difference in LS Mean|226.57|STANDARD_ERROR_OF_MEAN|33.425|<|0.001|TWO_SIDED|95.0|160.17|292.98||1-sided p-value was reported.|MMRM|||Procollagen 1 N-Terminal Propeptide|MMRM analysis over all post-baseline visits, with the change from baseline in bone turnover biomarkers as the outcome, treatment group, visit, and their interaction as fixed effect factors and participants as a random effect with adjustment for baseline bone turnover biomarkers.|292.98|160.17|<0.001
71846898|NCT02609048|143208349|SUPERIORITY||Difference in LSM|-9.0|STANDARD_ERROR_OF_MEAN|8.99||0.3236|TWO_SIDED|95.0|-27.4|9.4||Difference between means,p-value, and CIs are estimated by comparing each Seladelpar level with placebo using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||9.4|-27.4|0.3236
71846899|NCT02609048|143208349|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|9.92||0.8723|TWO_SIDED|95.0|-18.7|21.9||Difference between means,p-value, and CIs are estimated by comparing Seladelpar 200 mg versus 50 mg using ANCOVA model. Treatment group as factor, baseline score as a covariate, and change from baseline score as the response variable.|ANCOVA|||||21.9|-18.7|0.8723
71846900|NCT02609048|143208350|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|1.25||0.0115|TWO_SIDED|95.0|0.8|6.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||6.0|0.8|0.0115
71846901|NCT02609048|143208350|SUPERIORITY||Difference in LSM|1.8|STANDARD_ERROR_OF_MEAN|1.1||0.1256|TWO_SIDED|95.0|-0.5|4.0||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.0|-0.5|0.1256
71846902|NCT02609048|143208350|SUPERIORITY||Difference in LSM|1.7|STANDARD_ERROR_OF_MEAN|1.22||0.1842|TWO_SIDED|95.0|-0.9|4.2||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Cognitive Domain Score||4.2|-0.9|0.1842
71846903|NCT02609048|143208350|SUPERIORITY||Difference in LSM|3.7|STANDARD_ERROR_OF_MEAN|1.7||0.042|TWO_SIDED|95.0|0.1|7.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||7.2|0.1|0.0420
71846904|NCT02609048|143208350|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|1.54||0.6384|TWO_SIDED|95.0|-2.4|3.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||3.9|-2.4|0.6384
71846905|NCT02609048|143208350|SUPERIORITY||Difference in LSM|2.9|STANDARD_ERROR_OF_MEAN|1.73||0.1035|TWO_SIDED|95.0|-0.6|6.5||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Social Domain Score||6.5|-0.6|0.1035
71846906|NCT02609048|143208350|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.96||0.6967|TWO_SIDED|95.0|-1.6|2.4||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.4|-1.6|0.6967
71846907|NCT02609048|143208350|SUPERIORITY||Difference in LSM|0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6164|TWO_SIDED|95.0|-1.3|2.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Emotional Function Domain Score||2.2|-1.3|0.6164
71815171|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group Ratios (Serotype Ia)|0.96|||||TWO_SIDED|98.4|0.71|1.3||||||||1.3|0.71|
71898698|NCT02759146|143320783|SUPERIORITY||Least Square (LS) Mean|-1.85||||0.66|TWO_SIDED|95.0|-6.59|10.29|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practices, comparing continued meditative practice vs adding reflexology for weeks 5-12||10.29|-6.59|0.66
71898699|NCT02759146|143320784|SUPERIORITY||Difference between least squared means|-0.19||||0.62|TWO_SIDED|95.0|-0.95|0.57|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12||0.57|-0.95|0.62
71898700|NCT02759146|143320784|SUPERIORITY||Least Square (LS) Mean|-0.04||||0.95|TWO_SIDED|95.0|-1.15|1.22|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs adding reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continuing meditative practice vs adding reflexology for weeks 5-12||1.22|-1.15|0.95
71898701|NCT02759146|143320785|SUPERIORITY||Difference between least squared means|-0.14||||0.77|TWO_SIDED|95.0|-1.04|0.77|||Mixed Models Analysis||After 4 weeks of reflexology, comparing continued reflexology vs added meditative practice for weeks 5-12|Aim 2: After 4 weeks of reflexology, comparing continued reflexology vs adding meditative practice for weeks 5-12||0.77|-1.04|0.77
71898702|NCT02759146|143320785|SUPERIORITY||Least Square (LS) Mean|0.22||||0.67|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12|Aim 3: After 4 weeks of meditative practice, comparing continued meditative practice vs added reflexology for weeks 5-12||0.80|-1.23|0.67
71898703|NCT02759146|143320786|SUPERIORITY||Least Square (LS) Mean|0.09||||0.42|TWO_SIDED|95.0|-0.88|0.37|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.37|-0.88|0.42
71898704|NCT02759146|143320786|SUPERIORITY||Least Square (LS) Mean|-0.34||||0.29|TWO_SIDED|95.0|-0.98|0.29|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practices vs control for weeks 5-12||0.29|-0.98|0.29
71898705|NCT02759146|143320787|SUPERIORITY||Least Square (LS) Mean|-0.42||||0.15|TWO_SIDED|95.0|-1.0|0.15|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.15|-1.00|0.15
71898706|NCT02759146|143320787|SUPERIORITY||Least Square (LS) Mean|-0.2||||0.5|TWO_SIDED|95.0|-0.8|0.39|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.39|-0.80|0.50
71815172|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.81|||||TWO_SIDED|98.4|0.6|1.09||||||||1.09|0.6|
71815173|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ia)|0.84|||||TWO_SIDED|98.4|0.63|1.14||||||||1.14|0.63|
71815174|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|0.8|||||TWO_SIDED|98.4|0.49|1.29||||||||1.29|0.49|
71815175|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.05|||||TWO_SIDED|98.4|0.65|1.69||||||||1.69|0.65|
71815176|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype Ib)|1.32|||||TWO_SIDED|98.4|0.85|2.06||||||||2.06|0.85|
71815177|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.17|||||TWO_SIDED|98.4|0.66|2.07||||||||2.07|0.66|
71815178|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|1.06|||||TWO_SIDED|98.4|0.63|1.78||||||||1.78|0.63|
71815179|NCT01412801|143131675|SUPERIORITY_OR_OTHER||Vaccine Group ratios (Serotype III)|0.91|||||TWO_SIDED|98.4|0.52|1.58||||||||1.58|0.52|
71815180|NCT03300570|143131676|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71815181|NCT00116272|143131679|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77|||||TWO_SIDED|95.0|1.04|7.35|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||7.35|1.04|
71815182|NCT00116272|143131680|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37|||||TWO_SIDED|95.0|1.02|5.52|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height|||5.52|1.02|
71815183|NCT00116272|143131681|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.01|||||Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.|||2.01|0.70|
71815184|NCT00116272|143131683|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.2|1.12|||||Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.|||1.12|0.20|
71815185|NCT00116272|143131684|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.86|2.98|||||Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia|||2.98|0.86|
71815186|NCT00116272|143131685|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.2|||||TWO_SIDED|95.0|-0.65|0.26|||||Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.|||0.26|-0.65|
71815187|NCT00116272|143131686|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|21.79|||||TWO_SIDED|95.0|-83.32|126.91|||||Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.|||126.91|-83.32|
71815188|NCT00116272|143131687|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.|||0.63|-0.44|
71815189|NCT00116272|143131688|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|-0.09|||||TWO_SIDED|95.0|-0.43|0.26|||||Computed using linear regression, adjusted for maternal age (categorical).|||0.26|-0.43|
71815190|NCT00116272|143131689|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.22|1.05|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.05|0.22|
71898707|NCT02759146|143320788|SUPERIORITY||Least Square (LS) Mean|-0.27||||0.33|TWO_SIDED|95.0|-0.83|0.28|||Mixed Models Analysis||Comparing reflexology vs control for week 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||0.28|-0.83|0.33
71678651|NCT01246349|142875513|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||Results published comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the attributable effect of intervention (i.e., the difference in waist circumference change between the treatment and control groups from baseline to a 6-month follow-up).||||0.09
71846908|NCT02609048|143208350|SUPERIORITY||Difference in LSM|-0.1|STANDARD_ERROR_OF_MEAN|0.93||0.9548|TWO_SIDED|95.0|-2.0|1.9|||ANCOVA|||Emotional Function Domain Score||1.9|-2.0|0.9548
71846909|NCT02609048|143208350|SUPERIORITY||Difference in LSM|-0.2|STANDARD_ERROR_OF_MEAN|1.04||0.8286|TWO_SIDED|95.0|-2.4|1.9||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.9|-2.4|0.8286
71846910|NCT02609048|143208350|SUPERIORITY||Difference in LSM|4.2|STANDARD_ERROR_OF_MEAN|1.74||0.0226|TWO_SIDED|95.0|0.6|7.8||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||7.8|0.6|0.0226
71846911|NCT02609048|143208350|SUPERIORITY||Difference in LSM|-2.6|STANDARD_ERROR_OF_MEAN|1.92||0.1861|TWO_SIDED|95.0|-6.6|1.4||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||1.4|-6.6|0.1861
71846912|NCT02609048|143208350|SUPERIORITY||Difference in LSM|1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4159|TWO_SIDED|95.0|-2.4|5.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Fatigue Domain Score||5.7|-2.4|0.4159
71846913|NCT02609048|143208350|SUPERIORITY||Difference in LSM|0.7|STANDARD_ERROR_OF_MEAN|0.93||0.4848|TWO_SIDED|95.0|-1.3|2.6||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||2.6|-1.3|0.4848
71846914|NCT02609048|143208350|SUPERIORITY||Difference in LSM|-0.9|STANDARD_ERROR_OF_MEAN|1.05||0.4048|TWO_SIDED|95.0|-3.1|1.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Itch Domain Score||1.3|-3.1|0.4048
71846915|NCT02609048|143208350|SUPERIORITY||Difference in LSM|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0141|TWO_SIDED|95.0|0.6|4.7||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.7|0.6|0.0141
71846916|NCT02609048|143208350|SUPERIORITY||Difference in LSM|2.4|STANDARD_ERROR_OF_MEAN|0.9||0.0138|TWO_SIDED|95.0|0.5|4.2||Difference between means,p-value,and CIs are estimated comparing each Seladelpar level with placebo using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||4.2|0.5|0.0138
71846917|NCT02609048|143208350|SUPERIORITY||Difference in LSM|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7911|TWO_SIDED|95.0|-1.8|2.3||Difference between means,p-value,and CIs are estimated comparing Seladelpar 200 mg versus 50 mg using ANCOVA model.Treatment group as factor,baseline PBC 40 QoL domain score as covariate, change from baseline in domain score as response variable.|ANCOVA|||Symptoms Domain Score||2.3|-1.8|0.7911
71846918|NCT02485925|143208351|OTHER||Proportion of participants|80.7|||||TWO_SIDED|95.0|73.9|86.4|||||||95% confidence interval is based on Clopper-Pearson confidence interval|86.4|73.9|
71846919|NCT02485925|143208352|OTHER||Proportion of participants|99.5|||||TWO_SIDED|95.0|97.2|100.0|||||||95% confidence interval is based on Clopper-Pearson confidence interval|100.0|97.2|
71846920|NCT04181788|143208361|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|231.2|||||TWO_SIDED|90.0|190.09|281.21||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||281.21|190.09|
71846921|NCT04181788|143208362|OTHER|Ratio of experimental vs control|Ratio of experimental vs control|111.48|||||TWO_SIDED|90.0|86.31|143.99||||||Phase 2 600 mg SC Q6W (experimental) vs. Phase 2 300 mg SC Q4W (control)||143.99|86.31|
71846922|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.1491|STANDARD_ERROR_OF_MEAN|0.51||0.7695||95.0|-0.856|1.15||Alpha for significance=0.05 for all tests.|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician treatment arm."||1.15|-.856|.7695
71846923|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.5077||0.0878||95.0|-1.88|0.13||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm."||.13|-1.88|.0878
71898708|NCT02759146|143320788|SUPERIORITY||Least Square (LS) Mean|-0.36||||0.22|TWO_SIDED|95.0|-0.93|0.21|||Mixed Models Analysis|||Aim 4: Comparing meditative practice vs control for weeks 5-12||0.21|-0.93|0.22
71688679|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.27|||t-test, 2 sided|||FEV1 Day 8 (-0.75 hrs post-dose)||0.27|0.16|<0.0001
71898709|NCT02759146|143320789|SUPERIORITY||Least Square (LS) Mean|0.92||||0.17|TWO_SIDED|95.0|-8.62|1.52|||Mixed Models Analysis||Comparing reflexology vs control for weeks 5-12|Aim 4: Comparing reflexology vs control for weeks 5-12||1.52|-8.62|0.17
71898710|NCT02759146|143320789|SUPERIORITY||Least Square (LS) Mean|-4.48||||0.09|TWO_SIDED|95.0|-9.66|0.7|||Mixed Models Analysis||Comparing meditative practice vs control for weeks 5-12|Aim 4: Comparing meditative practice vs control for weeks 5-12||0.70|-9.66|0.09
71898711|NCT03408873|143320800|OTHER||Mean Difference (Final Values)|-31.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898712|NCT03408873|143320800|OTHER||Mean Difference (Final Values)|-11.7||||0.12|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.12
71898713|NCT03408873|143320801|OTHER||Mean Difference (Final Values)|-19.6||||0.0599|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.0599
71898714|NCT03408873|143320801|OTHER||Mean Difference (Final Values)|-3.2||||0.63|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 28 participants with baseline data only 11 had Week 24 data. Statistical Analysis was conducted for 11 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.63
71898715|NCT03408873|143320803|OTHER||Mean Difference (Final Values)|-10.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898716|NCT03408873|143320804|OTHER||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 19 had Week 24 data. Statistical Analysis was conducted for 19 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898717|NCT03408873|143320804|OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||<0.001
71898718|NCT03408873|143320805|OTHER||Mean Difference (Final Values)|-16.6|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898719|NCT03408873|143320805|OTHER|We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24) to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.|Mean Difference (Final Values)|-8.1||||0.003|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.003
71898720|NCT03408873|143320806|OTHER|We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data.|Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71898721|NCT03408873|143320806|OTHER||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
71898722|NCT03408873|143320807|OTHER||Mean Difference (Final Values)|0.8||||0.0566|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two sets of time-points: 1) difference between screen and week 24, and 2) between baseline and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant) between these time-points to determine whether the population medians differed.||||0.0566
71678652|NCT01246349|142875515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|1.265||0.88|TWO_SIDED|95.0|-2.301|2.668|||Regression, Linear|||"Based on previous research , baseline CDSS means were expected between 5 - 6.5 with a SD of 3 - 4. It was hypothesized that an attributable effect of 1.5 would be detected.~Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy \[CDSS\] change between the treatment and control groups from baseline to a 6 month follow-up)."||2.668|-2.301|0.88
71678653|NCT04934189|142875519|OTHER||Mean Difference (Final Values)|0.295|STANDARD_DEVIATION|1.184||0.08|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.08
71678654|NCT04934189|142875520|OTHER||Mean Difference (Net)|0.417|STANDARD_DEVIATION|0.89||0.005|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up mean) was statistically different from the baseline mean.||||.005
71678655|NCT04934189|142875522|OTHER||Mean Difference (Net)|-0.103|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||0.40
71678656|NCT04934189|142875523|OTHER||Mean Difference (Net)|-0.01|STANDARD_DEVIATION|2.08||0.49|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month follow-up) mean was statistically different from the baseline mean.||||.49
71678657|NCT04934189|142875525|OTHER||Mean Difference (Net)|0.195|STANDARD_DEVIATION|1.41||0.21|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.21
71846924|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.2414|STANDARD_ERROR_OF_MEAN|0.5077||0.635||95.0|-0.76|1.25||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/physician treatment arm."||1.25|-.76|.635
71846925|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.06574|STANDARD_ERROR_OF_MEAN|0.5077||0.897||95.0|-1.0709|0.9394||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the older adult treatment arm."||.9394|-1.0709|.897
71846926|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.01126|STANDARD_ERROR_OF_MEAN|0.5077||0.9823||95.0|-1.0164|0.9939||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the physician/older adult treatment arm."||.9939|-1.0164|.9823
71678658|NCT04934189|142875526|OTHER||Mean Difference (Net)|0.019|STANDARD_DEVIATION|1.43||0.47|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.47
71678659|NCT04934189|142875528|OTHER||Mean Difference (Net)|0.175|STANDARD_DEVIATION|1.02||0.16|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.16
71678660|NCT04934189|142875529|OTHER||Mean Difference (Net)|0.0481|STANDARD_DEVIATION|0.926||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.38
71678661|NCT04934189|142875531|OTHER||Mean Difference (Net)|0.179|STANDARD_DEVIATION|2.73||0.35|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.35
71846927|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.4928|STANDARD_ERROR_OF_MEAN|0.5077||0.3337||95.0|-1.4979|0.5124||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm."||.5124|-1.4979|.3337
71846928|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.2002|STANDARD_ERROR_OF_MEAN|0.5077||0.694||95.0|-0.8049|1.2054||ALPHA=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult/physician treatment arm."||1.2054|-.8049|.694
71846929|NCT04837937|143208398|SUPERIORITY||Actual Intercept value|54.9056|STANDARD_ERROR_OF_MEAN|0.5077|<|0.0001||95.0|53.9003|55.9109||this is the Intercept value for the GLMM evaluating all combinations of treatment and time- in other words, this is the mean well-being t-score across all combinations of tx and time. Estimates in these analyses are deviations from this intercept.|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the intercept (all tx=0).||55.9109|53.9003|<.0001
71846930|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.05579|STANDARD_ERROR_OF_MEAN|0.03516||0.1152||95.0|-0.1254|0.01383||alpha=0.05|Mixed Models Analysis|||Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This test evaluates the effect of time (measured as weeks since baseline).||.01383|-.1254|.1152
71846931|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.03261|STANDARD_ERROR_OF_MEAN|0.03516||0.3555||95.0|-0.1022|0.03699|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician treatment arm\*time."||.03699|-.1022|.3555
71846932|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.06825|STANDARD_ERROR_OF_MEAN|0.03516||0.0546||95.0|-0.00136|0.1379||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister treatment arm\*time."||.1379|-.00136|.0546
71846933|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.02597|STANDARD_ERROR_OF_MEAN|0.03516||0.4616||95.0|-0.04364|0.09557||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Physician treatment arm\*time."||.09557|-.04364|.4616
71846934|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.0498|STANDARD_ERROR_OF_MEAN|0.03516||0.1592||95.0|-0.0198|0.1194||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Older Adult treatment arm\*time."||.1194|-.0198|.1592
71846935|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.02435|STANDARD_ERROR_OF_MEAN|0.03516||0.4899||95.0|-0.09396|0.04526|||Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Physician/Older Adult treatment arm\*time."||.04526|-.09396|.4899
71846936|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|0.000697|STANDARD_ERROR_OF_MEAN|0.03516||0.9842||95.0|-0.06891|0.0703||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the sister/older adult treatment arm\*time."||.0703|-.06891|.9842
71846937|NCT04837937|143208398|SUPERIORITY||Mean Difference (Final Values)|-0.01255|STANDARD_ERROR_OF_MEAN|0.03516||0.7217||95.0|-0.08216|0.05705||alpha=0.05|Mixed Models Analysis|||"Generalized Linear Mixed Model (all models evaluated in SAS 9.4) testing all levels and combinations of treatments and time as fixed effects, controlling for repeated assessments within-subjects, for effect on the outcome of change in Neuro-QoL positive affect and well being score. This result is for the Sister/Older Adult/Physician treatment arm\*time."||.05705|-.08216|.7217
71846938|NCT04837937|143208399|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_DEVIATION|6.55||0.21||95.0|-1.9|0.42||Threshold for statistical significance was alpha=0.05.|2-sided paired t-Test|||Univariate ANOVA- analytic variable is change in PROMIS Anxiety score from baseline to T3. Test is a paired T-Test.||.42|-1.90|.21
71846939|NCT04837937|143208400|SUPERIORITY||Mean Difference (Final Values)|-3.24|STANDARD_DEVIATION|11.54||0.0021||95.0|-5.28|-1.2||Threshold for significance was 0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in Zarit Caregiver Burden Score, Baseline to 1-month post-intervention. Test was a 2-sided dependent samples t-test.||-1.20|-5.28|.0021
71846940|NCT04837937|143208401|SUPERIORITY||Mean Difference (Final Values)|-1.19|STANDARD_DEVIATION|8.1||0.1||95.0|-2.62|0.25||Alpha for statistical significance was 0.05|2-Sided Paired T Test|||Univariate ANOVA- analytic variable is change in PROMIS Fatigue score from baseline to T3. Test is a paired T-Test.||.25|-2.62|.10
71846941|NCT04837937|143208402|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|7.83||0.9754||95.0|-1.36|1.41|||2-sided paired (dependent sample) t-test|||Univariate ANOVA on change in PROMIS short form General Self Efficacy T-Score, baseline to one month post-intervention. Test is a 2-sided paired (dependent sample) t-test.||1.41|-1.36|.9754
71846942|NCT04837937|143208404|SUPERIORITY||Mean Difference (Final Values)|0.1296|STANDARD_DEVIATION|4.91||0.77||95.0|-0.74|1.0||Threshold for significance is 0.05|2-sided Paired T-Test|||Univariate ANOVA on change in T-Score between baseline and 1 month post-intervention. Test is a 2-sided paired t-test.||1.00|-.74|.77
71846943|NCT04837937|143208405|SUPERIORITY||Mean Difference (Final Values)|0.7618|STANDARD_DEVIATION|6.16||0.1694||95.0|-0.33|1.85||alpha threshold for significance was 0.05.|two-sided paired T-Test|||Univariate ANOVA on change in T-score between baseline and one month post-intervention. Test is a two-sided paired t-test.||1.85|-.33|.1694
71846944|NCT04837937|143208410|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|16.44||0.76||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Avoiding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.76
71846945|NCT04837937|143208410|SUPERIORITY||Mean Difference (Final Values)|2.25|STANDARD_DEVIATION|16.33||0.13||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Compromising Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.13
71846946|NCT04837937|143208410|SUPERIORITY||Mean Difference (Final Values)|-6.85|STANDARD_DEVIATION|18.76|<|0.0001||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Forcing Score (out of 100) between Baseline and 1 Month Post-Intervention.||||<.0001
71846947|NCT04837937|143208410|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|15.62||0.86||||||Alpha for Significance=0.05|ANOVA|||Univariate ANOVA on change in Problem Solving Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.86
71846948|NCT04837937|143208410|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|12.3||0.32||||||Alpha for significance=0.05|ANOVA|||Univariate ANOVA on change in Yielding Score (out of 100) between Baseline and 1 Month Post-Intervention.||||.32
71898723|NCT03408873|143320808|OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared for the primary and secondary outcomes across two time-points: difference between screen and week 24. A non-parametric Wilcoxon signed-rank test compared these repeated measurements (matched on participant with complete data) between these time-points to determine whether the population medians differed.||||<0.001
71898724|NCT03408873|143320809|OTHER||Mean Difference (Final Values)|17.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898725|NCT03408873|143320810|OTHER||Mean Difference (Final Values)|16.9|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between baseline \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with baseline data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. The mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898726|NCT03408873|143320811|OTHER||Mean Difference (Final Values)|14.7|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 29 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898727|NCT03408873|143320812|OTHER||Mean Difference (Final Values)|19.2|||<|0.001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||<0.001
71898728|NCT03408873|143320813|OTHER||Mean Difference (Final Values)|-0.5||||0.73|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.73
71898729|NCT03408873|143320814|OTHER||Mean Difference (Final Values)|-10.7||||0.02|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||We compared the repeated measure outcome across 2 time-points (difference between screen \& week 24 to determine whether the population medians differed matched on participant with complete data. Of the 30 participants with screen data, only 21 had Week 24 data. Statistical Analysis was conducted for 21 participants with data at the 2 timepoints. Thus, the mean difference reported is not consistent with the mean values reported because only those with complete data were included in the analysis.||||0.02
71898730|NCT01600131|143320815|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|1.72||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.693
71898731|NCT01600131|143320816|SUPERIORITY||Slope|-2.17|STANDARD_ERROR_OF_MEAN|2.07||0.693|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group x time interaction|||||0.693
71898732|NCT01600131|143320817|SUPERIORITY||Slope|-2.08|STANDARD_ERROR_OF_MEAN|1.08||0.055|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.055
71898733|NCT01600131|143320818|SUPERIORITY||Slope|-1.08|STANDARD_ERROR_OF_MEAN|1.15||0.346|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.346
71898734|NCT01600131|143320820|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|1.79||0.688|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.688
71898735|NCT01600131|143320821|SUPERIORITY||Slope|-1.52|STANDARD_ERROR_OF_MEAN|1.87||0.418|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.418
71898736|NCT01600131|143320822|SUPERIORITY||Slope|-1.94|STANDARD_ERROR_OF_MEAN|1.45||0.18|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.180
71898737|NCT01600131|143320823|SUPERIORITY||Slope|-0.63|STANDARD_ERROR_OF_MEAN|0.65||0.332|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.332
71898738|NCT01600131|143320824|SUPERIORITY||Slope|-0.56|STANDARD_ERROR_OF_MEAN|0.56||0.318|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.318
71898739|NCT01600131|143320825|SUPERIORITY||Slope|2.33|STANDARD_ERROR_OF_MEAN|1.31||0.077|TWO_SIDED|||||a priori \<.05|Mixed Models Analysis||group X time interaction|||||0.077
71898740|NCT01600131|143320826|SUPERIORITY||Slope|1.5|STANDARD_ERROR_OF_MEAN|1.46||0.305|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.305
71898741|NCT01600131|143320829|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.94||0.514|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.514
71898742|NCT01600131|143320830|SUPERIORITY||Slope|-1.61|STANDARD_ERROR_OF_MEAN|0.94||0.09|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.090
71898743|NCT01600131|143320831|SUPERIORITY||Slope|6.71|STANDARD_ERROR_OF_MEAN|2.57||0.009|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.009
71898744|NCT01600131|143320832|SUPERIORITY||Slope|4.29|STANDARD_ERROR_OF_MEAN|3.53||0.225|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.225
71898745|NCT01600131|143320833|SUPERIORITY||Slope|3.75|STANDARD_ERROR_OF_MEAN|4.89||0.443|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.443
71898746|NCT01600131|143320834|SUPERIORITY||Slope|7.39|STANDARD_ERROR_OF_MEAN|5.23||0.158|TWO_SIDED||||||Mixed Models Analysis||group x time interaction|||||0.158
71898747|NCT01600131|143320835|SUPERIORITY||Slope|7.28|STANDARD_ERROR_OF_MEAN|3.64||0.046|TWO_SIDED|||||a priori \<.05 threshold|Mixed Models Analysis||group X time interaction|||||0.046
71898748|NCT01600131|143320836|SUPERIORITY||Slope|5.54|STANDARD_ERROR_OF_MEAN|3.83||0.149|TWO_SIDED||||||Mixed Models Analysis||group X time interaction|||||0.149
71898749|NCT01600131|143320837|SUPERIORITY||Slope|4.16|STANDARD_ERROR_OF_MEAN|1.95||0.034|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.034
71898750|NCT01600131|143320838|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|1.52||0.846|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.846
71898751|NCT01600131|143320839|SUPERIORITY||Slope|1.67|STANDARD_ERROR_OF_MEAN|2.17||0.0442|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||.0442
71898752|NCT01600131|143320840|SUPERIORITY||Slope|1.98|STANDARD_ERROR_OF_MEAN|1.88||0.293|TWO_SIDED|||||a priori \<0.05|Mixed Models Analysis||group X time interaction|||||0.293
71898753|NCT02214186|143320884|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
71898754|NCT02214186|143320885|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
71898755|NCT02214186|143320886|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures||||||<0.05
71898756|NCT02214186|143320887|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
71898757|NCT02214186|143320888|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|ANOVA for repeated measures.||||||>0.05
71898758|NCT02214186|143320889|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test||||||<0.05
71898759|NCT02214186|143320890|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71898760|NCT02214186|143320891|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|ANOVA for repeated measures.||||||<0.05
71898761|NCT02214186|143320892|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71898762|NCT04392011|143320926|OTHER||AUC ratio (geometric mean)|1.39|||||TWO_SIDED|90.0|1.23|1.57||||||||1.57|1.23|
71898763|NCT04392011|143320927|OTHER||AUC ratio (geometric mean)|0.99|||||TWO_SIDED|90.0|0.83|1.19||||||||1.19|0.83|
71898764|NCT04392011|143320929|OTHER||Cmax ratio (midazolam)|1.5|||||TWO_SIDED|90.0|1.32|1.7||||||||1.70|1.32|
71898765|NCT04392011|143320929|OTHER||Cmax ratio (dextromethorphan)|0.96|||||TWO_SIDED|90.0|0.78|1.19||||||||1.19|0.78|
71898766|NCT04392011|143320931|OTHER||half-life ratio (dextromethorphan)|1.0|||||TWO_SIDED|90.0|0.92|1.08||||||||1.08|0.92|
71898767|NCT04392011|143320931|OTHER||half-life ratio (midazolam)|1.07|||||TWO_SIDED|90.0|0.98|1.17||||||||1.17|0.98|
71898768|NCT02086565|143320994|SUPERIORITY||Group differences in expected 12 month c|-0.21|||||TWO_SIDED|95.0|-0.56|0.15||||||||0.15|-0.56|
71898769|NCT02086565|143320995|SUPERIORITY||Group differences in expected 12 month c|0.19|||||TWO_SIDED|95.0|-0.27|0.68|||||Estimation parameter: Other. Group differences in expected 12 month change from baseline|||0.68|-0.27|
71898770|NCT02086565|143320996|SUPERIORITY||Group differences in expected 12 month c|-0.6|||||TWO_SIDED|95.0|-2.21|0.97||||||||0.97|-2.21|
71898771|NCT02086565|143320997|SUPERIORITY||Group differences in expected 12 month c|-0.53|||||TWO_SIDED|95.0|-1.08|-0.24||||||||-0.24|-1.08|
71898772|NCT02086565|143320998|SUPERIORITY||Group differences in expected 12 month c|-0.09|||||TWO_SIDED|95.0|-0.24|0.06||||||||0.06|-0.24|
71898773|NCT02116972|143320999|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.0821|TWO_SIDED|95.0|-1.22|0.07|||Logitudinal mixed effects model|||The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.||0.07|-1.22|0.0821
71898774|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.54|0.92||||||Public insurance||0.92|0.54|
71898775|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|1.5|2.46||||||Diabetes support service available||2.46|1.50|
71898776|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.38|2.49||||||Baseline HbA1c \> 7.80 (reference:HbA1c≤7.80 median)||2.49|1.38|
71898777|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.15|2.07||||||Baseline HbA1c missing (reference:HbA1c≤7.80 median)||2.07|1.15|
71898778|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.13|1.88||||||Diabetes duration \> 11 years||1.88|1.13|
71898779|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.97|1.0||||||Age (per year increase)||1.00|0.97|
71898780|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|10.5|||||TWO_SIDED|95.0|3.3|33.41||||||Baseline insulin therapy: combination||33.41|3.30|
71898781|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|5.71|||||TWO_SIDED|95.0|1.77|18.37||||||Baseline insulin therapy: prandial only||18.37|1.77|
71898782|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|4.16|||||TWO_SIDED|95.0|3.02|5.73||||||Baseline insulin therapy: pre-mixed only||5.73|3.02|
71898783|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. IPC ranges from 1-5 with higher scores indicating more discrimination.|Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.39|0.65||||||Discrimination domain of the IPC||0.65|0.39|
71678662|NCT04934189|142875532|OTHER||Mean Difference (Net)|-0.335|STANDARD_DEVIATION|2.05||0.17|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean.||||.17
71678663|NCT04934189|142875536|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|2.18||||0.02|ONE_SIDED|||||A priori threshold for statistical significance was \<.05|t-test, 1 sided|||||||.02
71678664|NCT04934189|142875536|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|1.29||||0.1|ONE_SIDED|||||A priori threshold for statistical significant was p \<.05|t-test, 1 sided|||||||.10
71678665|NCT04934189|142875536|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|0.17||||0.43|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.43
71678666|NCT04934189|142875536|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|-0.68||||0.25|ONE_SIDED|||||A priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.25
71678667|NCT04934189|142875536|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.36||||0.36|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.36
71898784|NCT01400971|143321012|OTHER|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Diabetes Distress Scale total score \> 2||0.95|0.57|
71898785|NCT00325442|143321016|SUPERIORITY_OR_OTHER||Hodges-Lehmann|11.0||||0.072|TWO_SIDED|95.0|0.0|22.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||22|0|0.072
71898786|NCT00325442|143321017|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.062|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Change in Borg dyspnea score from Baseline to Week 16||0.0|-1.0|0.062
71898787|NCT00325442|143321018|SUPERIORITY_OR_OTHER|||||||0.491||95.0|||||Fisher Exact|||||||0.491
71898788|NCT00325442|143321019|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.011|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||Change in dyspnea-fatigue index from Baseline to Week 16||1.0|0.0|0.011
71898789|NCT00325442|143321021|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|13.0||||0.015|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|||Change in 6MWD from Baseline to Week 12||23.0|3.0|0.015
71678668|NCT04934189|142875536|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month followup) mean for pride was statistically different from the baseline mean.|t-test|-0.09||||0.47|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.47
71678669|NCT04934189|142875537|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for gender nonaffirmation was statistically different from the baseline mean.|t-test|3.76|||<|0.001|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided||||"A series of one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean was statistically different from the baseline mean for each of the five gender minority stress subscales measured. See below for T-scores and associated p-values for each statistical test.~Nonaffirmation (t = 3.76; p = .001) Internalized Transphobia (t = 2.01; p = .02) Negative Expectations (t = 2.06; p =.02) Community Connection (t = -0.82; p =.21) Pride (t = .01; p = .50 )"|||<.001
71678670|NCT04934189|142875537|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for internalized transphobia was statistically different from the baseline mean.|t-test|2.01||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance is p \< .05|t-test, 1 sided|||||||.02
71678671|NCT04934189|142875537|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for identity nondisclosure was statistically different from the baseline mean.|t-test|1.61||||0.06|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.06
71678672|NCT04934189|142875537|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for negative expectations was statistically different from the baseline mean.|t-test|2.06||||0.02|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.02
71678673|NCT04934189|142875537|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for community connection was statistically different from the baseline mean.|t-test|-0.818||||0.21|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.21
71678674|NCT04934189|142875537|OTHER|A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month followup) mean for pride was statistically different from the baseline mean.|t-test|0.009||||0.5|ONE_SIDED|||||The a priori threshold for statistical significance was p \< .05|t-test, 1 sided|||||||.50
71678675|NCT04934189|142875540|OTHER||Chi-squared|5.59||||0.04|TWO_SIDED|||||A priori threshold for statistical significance was p \<.05|Chi-squared|||For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting freedom from sexual victimization over a 6 month time period||||.04
71678676|NCT04934189|142875540|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting any exposure to nonpenetrative sexual assault over a 6 month time period|Chi-squared|0.21||||0.55|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.55
71678677|NCT04934189|142875540|OTHER|For this categorical data, chi-square tests of independence were performed to compare post-treatment (i.e., 3 month followup) vs 6 month followup numbers of participants reporting exposure to rape over a 6 month time period|Chi-squared|0.11||||0.59|TWO_SIDED|||||A priori threshold for statistical significance was p \< .05|Chi-squared|||||||.59
71846949|NCT04837937|143208411|SUPERIORITY||Mean Difference (Final Values)|3.09|STANDARD_DEVIATION|13.18||0.0012||95.0|||||ANOVA|||Univariate ANOVA on change in total Negotiation Knowledge score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0012
71846950|NCT04837937|143208411|SUPERIORITY||Mean Difference (Final Values)|4.933|STANDARD_DEVIATION|17.33||0.0018||||||alpha=0.05|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Interests score, Baseline 1-month. Threshold for significance was alpha=0.05.||||.0018
71846951|NCT04837937|143208411|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|19.69||0.91||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Power score, Baseline 1-month.||||.91
71846952|NCT04837937|143208411|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_DEVIATION|22.35||0.11||||||Threshold for significance was alpha=0.05.|ANOVA|||Univariate ANOVA on change in Negotiation Knowledge Rights score, Baseline 1-month.||||.11
71846953|NCT04837937|143208413|SUPERIORITY||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|5.73|<|0.0001||95.0|-3.09|-1.07||Threshold for significance is alpha=0.05.|2-sided dependent sample t-test|||Univariate ANOVA on change in negative affect score, baseline-1 month post-intervention. Test is a 2 sided dependent sample t-test.||-1.07|-3.09|<.0001
71846954|NCT04837937|143208413|SUPERIORITY||Mean Difference (Final Values)|0.344|STANDARD_DEVIATION|4.86||0.4305||95.0|-0.52|1.21|||2-sided dependent sample t-test|||Univariate ANOVA of change in positive affect score between baseline-1 month post-intervention. Test is a 2-sided dependent sample t-test.||1.21|-.52|.4305
71846955|NCT01823224|143208420|SUPERIORITY_OR_OTHER|||||||0.875|TWO_SIDED||||||Repeated analysis of variance|||||||0.875
71846956|NCT01823224|143208421|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Manova|||||||> 0.05
71846957|NCT02148705|143208427|SUPERIORITY||Odds Ratio (OR)|288.281|||<|0.0001|TWO_SIDED|95.0|35.549|13984.356|||Fisher Exact|||||13984.356|35.549|<0.0001
71846958|NCT02148705|143208428|SUPERIORITY||Odds Ratio (OR)|0.011|||<|0.0001|TWO_SIDED|95.0|0.003|0.044|||Chi-squared|||||0.044|0.003|<0.0001
71846959|NCT02148705|143208429|SUPERIORITY||Test Statistics|23.1429|||<|0.0001|TWO_SIDED||||||Generalized Wilcoxon-Gehan Test|Analysis is adjusted for Overall TW Depths, TBSA Group, Center Group, and Number of TWs||||||<0.0001
71846960|NCT02148705|143208430|SUPERIORITY||estimate|6505.8|STANDARD_ERROR_OF_MEAN|269.88|<|0.0001|TWO_SIDED|95.0|5974.41|7037.19|||Wilcoxon (Mann-Whitney)|Wilcoxon tests pooled using Rubin´s rule||||7037.19|5974.41|<0.0001
71846961|NCT01583166|143208432|OTHER|||||||0.837|||||||Fisher Exact|||||||0.837
71846962|NCT02310581|143208440|OTHER||LS Mean Difference|104.973|STANDARD_ERROR_OF_MEAN|39.2433||0.012|TWO_SIDED|95.0|25.13|184.81|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||184.81|25.13|0.012
71846963|NCT02310581|143208440|OTHER||LS Mean Difference|86.316|STANDARD_ERROR_OF_MEAN|37.5385||0.028|TWO_SIDED|95.0|9.94|162.69|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||162.69|9.94|0.028
71846964|NCT02310581|143208440|OTHER||LS Mean Difference|64.485|STANDARD_ERROR_OF_MEAN|39.2459||0.11|TWO_SIDED|95.0|-15.36|144.33|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||144.33|-15.36|0.110
71846965|NCT02310581|143208443|OTHER||LS Mean Difference|14.398|STANDARD_ERROR_OF_MEAN|4.739||0.005|TWO_SIDED|95.0|4.76|24.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||24.04|4.76|0.005
71846966|NCT02310581|143208443|OTHER||LS Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|4.5331||0.085|TWO_SIDED|95.0|-1.17|17.28|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||17.28|-1.17|0.085
71846967|NCT02310581|143208443|OTHER||LS Mean Difference|10.063|STANDARD_ERROR_OF_MEAN|4.7393||0.041|TWO_SIDED|95.0|0.42|19.7|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||19.70|0.42|0.041
71846968|NCT02310581|143208444|OTHER||LS Mean Difference|26.665|STANDARD_ERROR_OF_MEAN|8.1991||3|TWO_SIDED|95.0|9.98|43.35|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||43.35|9.98|0003
71846969|NCT02310581|143208444|OTHER||LS Mean Difference|21.605|STANDARD_ERROR_OF_MEAN|7.8429||0.009|TWO_SIDED|95.0|5.65|37.56|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||37.56|5.65|0.009
71678678|NCT04934189|142875542|OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|1.68||0.38|TWO_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 3-month) mean was statistically different from the baseline mean.||||.38
71846970|NCT02310581|143208444|OTHER||LS Mean Difference|22.143|STANDARD_ERROR_OF_MEAN|8.1997||0.011|TWO_SIDED|95.0|5.46|38.83|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||38.83|5.46|0.011
71846971|NCT02310581|143208445|OTHER||LS Mean Difference|63.881|STANDARD_ERROR_OF_MEAN|18.3971||0.001|TWO_SIDED|95.0|26.45|101.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||101.31|26.45|0.001
71846972|NCT02310581|143208445|OTHER||LS Mean Difference|50.284|STANDARD_ERROR_OF_MEAN|17.5979||0.007|TWO_SIDED|95.0|14.48|86.09|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||86.09|14.48|0.007
71846973|NCT02310581|143208445|OTHER||LS Mean Difference|56.879|STANDARD_ERROR_OF_MEAN|18.3984||0.004|TWO_SIDED|95.0|19.45|94.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.||||94.31|19.45|0.004
71846974|NCT00887224|143208457|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.|Log Rank|||||||<0.001
71846975|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9627|TWO_SIDED|95.0|-0.09|0.08||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.08|-0.09|0.9627
71846976|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.1046|TWO_SIDED|95.0|-0.02|0.21||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.21|-0.02|0.1046
71815191|NCT00116272|143131690|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.31|1.68|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||1.68|0.31|
71815192|NCT00116272|143131691|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.4|1.57|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, \& disease severity imputation indicator|||1.57|0.40|
71815193|NCT00116272|143131692|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.2|||||TWO_SIDED|95.0|-7.59|7.99|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake \& 32 weeks, disease severity imputation indicators|||7.99|-7.59|
71846977|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.0228|TWO_SIDED|95.0|0.02|0.25||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.25|0.02|0.0228
71846978|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.0064|TWO_SIDED|95.0|0.05|0.29||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||0.29|0.05|0.0064
71846979|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.001|TWO_SIDED|95.0|0.11|0.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||0.39|0.11|<0.001
71846980|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.12|0.43||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||0.43|0.12|<0.001
71846981|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.19|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||0.47|0.19|<0.001
71846982|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||<|0.001|TWO_SIDED|95.0|0.17|0.49||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||0.49|0.17|<0.001
71846983|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|||<|0.001|TWO_SIDED|95.0|0.25|0.62||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||0.62|0.25|<0.001
71846984|NCT00887224|143208459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||0.61|0.28|<0.001
71846985|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8853|TWO_SIDED|95.0|-0.41|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.47|-0.41|0.8853
71846986|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0081|TWO_SIDED|95.0|0.23|1.52||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||1.52|0.23|0.0081
71846987|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88||||0.0038|TWO_SIDED|95.0|0.28|1.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||1.47|0.28|0.0038
71898790|NCT00325442|143321022|SUPERIORITY_OR_OTHER||Hodges-Lehmann|9.0||||0.051|TWO_SIDED|95.0|0.0|18.0|||ANCOVA|||Change in 6MWD from Baseline to Week 8||18.0|0.0|0.051
71898791|NCT00325442|143321023|SUPERIORITY_OR_OTHER||Hodges-Lehmann ( H-L)|4.0||||0.238|TWO_SIDED|95.0|-2.4|12.0|||ANCOVA|||Change in 6MWD from Baseline to Week 4||12.0|-2.4|0.238
71815194|NCT00116272|143131693|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|1.53|||||TWO_SIDED|95.0|-5.76|8.81|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).|||8.81|-5.76|
71815195|NCT00116272|143131694|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|0.27|||||TWO_SIDED|95.0|-6.12|6.65|||||Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.|||6.65|-6.12|
71815196|NCT00116272|143131695|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.37|1.62|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.|||1.62|0.37|
71815197|NCT00116272|143131696|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.43|3.14|||||Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.|||3.14|0.43|
71815198|NCT00116272|143131697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.29|2.65|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.|||2.65|0.29|
71678679|NCT04934189|142875543|OTHER||Mean Difference (Net)|-0.265|STANDARD_DEVIATION|2.21||0.25|ONE_SIDED||||||t-test, 1 sided|||A one-tailed paired samples T-test was conducted to determine whether the post-treatment (i.e., 6-month) mean was statistically different from the baseline mean.||||.25
71678680|NCT03962790|142875544|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the credible interval (CrI) of the mean difference between Test and Control was greater than -5.|Posterior Mean Difference|0.09|STANDARD_DEVIATION|2.281|||TWO_SIDED|95.0|-4.37|4.65|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||4.65|-4.37|
71678681|NCT03962790|142875545|NON_INFERIORITY|Non-inferiority is established if the lower limit of the 95% credible interval is above -5 points in CLUE Scale.|Posterior Mean Difference|-1.02|STANDARD_DEVIATION|1.565|||TWO_SIDED|95.0|-4.07|2.06|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||2.06|-4.07|
71678682|NCT03962790|142875546|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.001|STANDARD_DEVIATION|0.0054|||TWO_SIDED|95.0|-0.012|0.01|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.010|-0.012|
71678683|NCT03962790|142875546|NON_INFERIORITY|Non-inferiority was declared if the upper bound of the CrI of the mean difference between Test and Control was less than 0.05.|Posterior Mean Difference|-0.002|STANDARD_DEVIATION|0.0057|||TWO_SIDED|95.0|-0.014|0.009|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.009|-0.014|
71678684|NCT03962790|142875547|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the CrI of the mean difference between Test and Control was greater than -1.|Posterior Mean Difference|0.02|STANDARD_DEVIATION|0.168|||TWO_SIDED|95.0|-0.32|0.34|||||Posterior mean difference was calculated as Test - Control|Bayesian repeated measurement random-effects model was used to compare between Test and Control lenses.||0.34|-0.32|
71815199|NCT00116272|143131698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.47|4.02|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||4.02|0.47|
71815200|NCT00116272|143131700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.65|1.69|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.|||1.69|0.65|
71815201|NCT02296190|143131710|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||Statistical analysis was performed with the Fisher's exact test to compare the conversion rate between the MSP-2017 groups and the placebo group.||||<0.05
71678685|NCT01286168|142875550|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.02
71678686|NCT01286168|142875551|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.03
71678687|NCT01286168|142875552|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|||Antisepsis and Control sides were compared.||||0.003
71678688|NCT01286168|142875553|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.13
71678689|NCT01286168|142875554|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||McNemar|||Antisepsis and Control sides were compared.||||0.45
71678690|NCT01286168|142875555|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.02
71678691|NCT01286168|142875555|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.02
71678692|NCT01286168|142875556|SUPERIORITY_OR_OTHER|||||||0.004|||||||Likelihood-ratio test|||Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.||||0.004
71678693|NCT01286168|142875557|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.||||0.003
71678694|NCT01286168|142875557|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.||||0.003
71678695|NCT04594941|142875566|OTHER||Least Sqaure (LS) Mean Difference|-0.149|STANDARD_ERROR_OF_MEAN|0.754||0.8452|TWO_SIDED|90.0|-1.431|1.133|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.133|-1.431|0.8452
71678696|NCT04594941|142875566|OTHER||LS Mean Difference|-0.015|STANDARD_ERROR_OF_MEAN|1.109||0.989|TWO_SIDED|90.0|-1.899|1.868|||Mixed-effects model for repeated measure|||"SPE VS HPLC: Reader 1~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.868|-1.899|0.9890
71815202|NCT03682705|143131717|SUPERIORITY||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|90.0|-2.03|-0.85|||t-test, 2 sided|||Mixed-Effect Model Repeated Measure (MMRM) analysis was conducted, testing the superiority of the combination of upadacitinib 15 mg and elsubrutinib 60 mg compared to placebo at Week 12. Data collected after a participant discontinued study drug was considered as missing. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline DAS28 (CRP) measurement.||-0.85|-2.03|<0.001
71815203|NCT01960530|143131847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|60.12|||||TWO_SIDED|90.0|54.69|66.1||||||Evaluation of Cmax||66.10|54.69|
71815204|NCT01960530|143131847|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|106.83|||||TWO_SIDED|90.0|96.92|117.76||||||||117.76|96.92|
71815205|NCT01960530|143131852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|86.99|||||TWO_SIDED|90.0|79.23|95.52||||||||95.52|79.23|
71815206|NCT01960530|143131852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|89.96|||||TWO_SIDED|90.0|81.72|99.04||||||||99.04|81.72|
71846988|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|||<|0.001|TWO_SIDED|95.0|0.76|2.03||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||2.03|0.76|<0.001
71846989|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||<|0.001|TWO_SIDED|95.0|0.86|2.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||2.39|0.86|<0.001
71846990|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.68|||<|0.001|TWO_SIDED|95.0|0.83|2.54||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||2.54|0.83|<0.001
71846991|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|||<|0.001|TWO_SIDED|95.0|1.23|2.86||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||2.86|1.23|<0.001
71846992|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.95|||<|0.001|TWO_SIDED|95.0|1.06|2.84||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||2.84|1.06|<0.001
71846993|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|||<|0.001|TWO_SIDED|95.0|1.31|3.3||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||3.30|1.31|<0.001
71846994|NCT00887224|143208460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|||<|0.001|TWO_SIDED|95.0|1.39|3.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||3.32|1.39|<0.001
71846995|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9142|TWO_SIDED|95.0|-0.24|0.27||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1||0.27|-0.24|0.9142
71846996|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.0069|TWO_SIDED|95.0|0.15|0.91||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2||0.91|0.15|0.0069
71846997|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0023|TWO_SIDED|95.0|0.21|0.95||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3||0.95|0.21|0.0023
71898792|NCT00325442|143321024|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|24.0||||0.121|TWO_SIDED|95.0|0.0|45.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||45|0|0.121
71815207|NCT01301274|143131853|NON_INFERIORITY_OR_EQUIVALENCE|beta error 20%, alfa error 5%, diminished 2 mEq/L between groups||||||0.04||95.0|||||t-test, 2 sided|||||||0.04
71815208|NCT01301274|143131854|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||without adjust|Chi-squared|||||||0.081
71815209|NCT01301274|143131855|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||||||0.396
71815210|NCT01301274|143131856|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||t-test, 2 sided|||||||0.129
71815211|NCT02439749|143131884|SUPERIORITY||||||<|0.001||||||p\<0.05 required for significance|ANCOVA|||||||<0.001
71815212|NCT02439749|143131888|SUPERIORITY|||||||0.026||||||p\<0.05 required for significance.|ANCOVA|||||||0.026
71815213|NCT02439749|143131889|SUPERIORITY|||||||0.052||||||p\<0.05 required for significance.|ANCOVA|||||||0.052
71815214|NCT02439749|143131890|SUPERIORITY|||||||0.07||||||p\<0.05 required for significance.|ANCOVA|||||||0.070
71815215|NCT02439749|143131891|SUPERIORITY|||||||0.009||||||p=\<0.05 required for significance.|ANCOVA|||||||0.009
71815216|NCT04512066|143131904|OTHER||treatment effect|0.6||||0.849|TWO_SIDED|90.0|-4.58|5.78|||Mixed Models Analysis|||||5.78|-4.58|0.849
71815217|NCT04512066|143131904|OTHER||treatment effect|-2.83||||0.362|TWO_SIDED|90.0|-7.96|2.29|||Mixed Models Analysis|||||2.29|-7.96|0.362
71815218|NCT04512066|143131904|OTHER||treatment effect|-10.45||||0.001|TWO_SIDED|90.0|-15.46|-5.43|||Mixed Models Analysis|||||-5.43|-15.46|0.001
71898793|NCT00325442|143321025|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|15.0||||0.069|TWO_SIDED|95.0|-7.0|41.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||41|-7|0.069
71846998|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|||<|0.001|TWO_SIDED|95.0|0.49|1.28||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4||1.28|0.49|<0.001
71846999|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.88|||<|0.001|TWO_SIDED|95.0|0.43|1.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6||1.32|0.43|<0.001
71847000|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|||<|0.001|TWO_SIDED|95.0|0.58|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10||1.58|0.58|<0.001
71847001|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|||<|0.001|TWO_SIDED|95.0|0.66|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||1.58|0.66|<0.001
71847002|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||<|0.001|TWO_SIDED|95.0|0.76|1.83||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18||1.83|0.76|<0.001
71847003|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.001|TWO_SIDED|95.0|0.7|1.76||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22||1.76|0.70|<0.001
71847004|NCT00887224|143208461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|||<|0.001|TWO_SIDED|95.0|0.75|1.79||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||1.79|0.75|<0.001
71847005|NCT00887224|143208462|SUPERIORITY_OR_OTHER||Adjusted odds ratio|2.85|||<|0.0001|TWO_SIDED|95.0|1.93|4.2||Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.|Regression, Logistic|||Wald 95% CI for adjusted odds ratio.||4.20|1.93|<0.0001
71847006|NCT00887224|143208463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.14|||<|0.001|TWO_SIDED|95.0|-3.03|-1.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14||-1.24|-3.03|<0.001
71847007|NCT00887224|143208463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|||<|0.001|TWO_SIDED|95.0|-3.29|-1.34||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26||-1.34|-3.29|<0.001
71847008|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02||||0.6772|TWO_SIDED|95.0|-3.82|5.87||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Absenteeism||5.87|-3.82|0.6772
71847009|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.9059|TWO_SIDED|95.0|-5.91|5.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Absenteeism||5.24|-5.91|0.9059
71847010|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.91||||0.0414|TWO_SIDED|95.0|0.27|13.55||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Presenteeism||13.55|0.27|0.0414
71847011|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.24||||0.0129|TWO_SIDED|95.0|1.77|14.71||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Presenteeism||14.71|1.77|0.0129
71847012|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.48||||0.0402|TWO_SIDED|95.0|0.34|14.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Work Productivity Loss||14.61|0.34|0.0402
71898794|NCT00325442|143321026|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|4.0||||0.889|TWO_SIDED|95.0|-15.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-15|0.889
71898795|NCT00325442|143321027|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|0.0||||0.966|TWO_SIDED|95.0|-23.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-23|0.966
71898796|NCT00325442|143321029|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.853|TWO_SIDED|95.0|-16.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-16|0.853
71898797|NCT00325442|143321030|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|7.0||||0.327|TWO_SIDED|95.0|-7.0|21.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||21|-7|0.327
71898798|NCT00325442|143321031|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|29.5||||0.085|TWO_SIDED|95.0|1.0|73.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||73|1|0.085
71815219|NCT00445679|143131919|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-3.13|||||TWO_SIDED|95.0|-12.62|6.37||||||||6.37|-12.62|
71815220|NCT00445679|143131919|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|0.88|||||TWO_SIDED|95.0|-8.5|10.25||||||||10.25|-8.50|
71815221|NCT00445679|143131919|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-2.17|||||TWO_SIDED|95.0|-11.68|7.33||||||||7.33|-11.68|
71815222|NCT00445679|143131920|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.714
71815223|NCT00445679|143131920|SUPERIORITY_OR_OTHER|||||||0.653||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.653
71815224|NCT00445679|143131920|SUPERIORITY_OR_OTHER|||||||0.881||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.881
71815225|NCT00445679|143131921|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.450
71815226|NCT00445679|143131921|SUPERIORITY_OR_OTHER|||||||0.452||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.452
71815227|NCT00445679|143131921|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Cochran-Mantel-Haenszel|||Final on-therapy population||||0.850
71815228|NCT01353222|143131932|SUPERIORITY||Hazard Ratio (HR)|1.141||||0.6188|TWO_SIDED|95.0|0.679|1.918|||From a stratified log-rank test, stratif||Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.|||1.918|0.679|0.6188
71815229|NCT01806584|143131960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED|||||p-value based on log rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.138
71815230|NCT01806584|143131961|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.312
71815231|NCT01806584|143131962|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED|||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency||||0.093
71815232|NCT01806584|143131963|SUPERIORITY_OR_OTHER_LEGACY||Mean treatment difference|0.23|||||TWO_SIDED|95.0|-0.942|1.402||||||||1.402|-0.942|
71815233|NCT02991482|143131986|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
71815234|NCT00871403|143132000|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.2647|TWO_SIDED|95.0|0.43|1.28|||Log Rank||The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||1.28|0.43|0.2647
71815235|NCT00871403|143132003|SUPERIORITY_OR_OTHER||percent difference in response|-12.0||||0.2113|TWO_SIDED|95.0|-30.6|7.2|||Binomial asymptotic||The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m\^2 to Cisplatin 75 mg/m\^2 plus pemetrexed 500 mg/m\^2.|||7.2|-30.6|0.2113
71815236|NCT02150837|143132040|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.||||||<0.0001
71815237|NCT00659984|143132144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.2||||0.363|TWO_SIDED|95.0|-3.4|13.9|||Cochran Armitage Trend Test|||||13.9|-3.4|0.363
71815238|NCT01737684|143132152|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.27|||||TWO_SIDED|90.0|0.96|1.67|||ANCOVA|||||1.67|0.96|
71815239|NCT01737684|143132155|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.35|||||TWO_SIDED|90.0|0.88|2.06|||ANCOVA|||||2.06|0.88|
71815240|NCT01691521|143132158|SUPERIORITY_OR_OTHER||Rate Ratio|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.72||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.|||0.72|0.40|<0.001
71815241|NCT01691521|143132158|SUPERIORITY_OR_OTHER||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.35|0.64||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 100 mg SC arm divided by the number of exacerbations per year in the placebo arm.|||0.64|0.35|<0.001
71815242|NCT01480596|143132163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|1.592||0.256|TWO_SIDED|95.0|-5.08|1.4|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||1.40|-5.08|0.256
71815243|NCT01480596|143132164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.082||95.0|0.87|19.02|||exact methods|||||19.02|0.87|0.082
71815244|NCT01480596|143132165|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.827||95.0|0.05|4.35|||exact methods|||||4.35|0.05|0.827
71815245|NCT01480596|143132166|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.184|TWO_SIDED|95.0|0.62|10.1|||Cochran-Mantel-Haenszel|||||10.10|0.62|0.184
71815246|NCT01480596|143132168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|1.228||0.175|TWO_SIDED|95.0|-4.2|0.8|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||0.80|-4.20|0.175
71815247|NCT01480596|143132168|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.31|STANDARD_ERROR_OF_MEAN|1.267||0.31|TWO_SIDED|95.0|-3.89|1.28|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.28|-3.89|0.310
71815248|NCT01480596|143132168|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|1.272||0.081|TWO_SIDED|95.0|-4.88|0.3|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||0.30|-4.88|0.081
71815249|NCT01480596|143132169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|1.486||0.972|TWO_SIDED|95.0|-2.97|3.07|||Mixed Models Analysis||Standard error of mean is for adjusted difference.|||3.07|-2.97|0.972
71815250|NCT01480596|143132170|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||1|TWO_SIDED|95.0|0.26|5.48|||exact methods|||||5.48|0.26|1.000
71815251|NCT01480596|143132171|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.53|TWO_SIDED|95.0|0.03|2.89|||exact methods|||||2.89|0.03|0.530
71815252|NCT01480596|143132172|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.7||||0.175|TWO_SIDED|95.0|0.64|11.46|||Cochran-Mantel-Haenszel|||||11.46|0.64|0.175
71815253|NCT01480596|143132174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.245||0.423|TWO_SIDED|95.0|-3.56|1.53|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||1.53|-3.56|0.423
71815254|NCT01480596|143132174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|1.361||0.986|TWO_SIDED|95.0|-2.76|2.8|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||2.80|-2.76|0.986
71815255|NCT01480596|143132174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.43||0.848|TWO_SIDED|95.0|-3.21|2.65|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||2.65|-3.21|0.848
71815256|NCT01480596|143132180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.707||0.483|TWO_SIDED|95.0|-1.94|0.93|||Mixed Models Analysis||Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.|||0.93|-1.94|0.483
71898799|NCT00325442|143321032|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|5.0||||0.615|TWO_SIDED|95.0|-12.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||24|-12|0.615
71898800|NCT00325442|143321033|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|17.0||||0.23|TWO_SIDED|95.0|-6.0|40.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||40|-6|0.230
71898801|NCT00325442|143321034|SUPERIORITY_OR_OTHER||Hodges-Lehmann (H-L)|10.0||||0.209|TWO_SIDED|95.0|-6.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16||28|-6|0.209
71898802|NCT01729598|143321037|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71898803|NCT01729598|143321038|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.19
71815257|NCT01480596|143132180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.844||0.711|TWO_SIDED|95.0|-2.03|1.4|||Mixed Models Analysis||Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.|||1.40|-2.03|0.711
71815258|NCT01480596|143132181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.757||0.028|TWO_SIDED|95.0|-3.3|-0.2|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.|||-0.20|-3.30|0.028
71898804|NCT01729598|143321039|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71898805|NCT01729598|143321040|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||||||0.31
71898806|NCT00455858|143321059|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.356|||<|0.0001||95.0|-1.368|-1.344|||t-test|||||-1.344|-1.368|<.0001
71815259|NCT01480596|143132181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.887||0.756|TWO_SIDED|95.0|-2.1|1.55|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.|||1.55|-2.10|0.756
71898807|NCT00455858|143321060|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-1.338|||<|0.0001||95.0|-1.35|-1.327|||t-test|||||-1.327|-1.350|<.0001
71898808|NCT00455858|143321061|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-69.553|||<|0.0001||95.0|-70.047|-69.06|||Paired t-test|||Estimated mean decrease in FPG at week 12||-69.060|-70.047|<.0001
71898809|NCT00455858|143321061|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-72.159|||<|0.0001||95.0|-72.647|-71.671|||Paired t-test|||Estimated mean decrease in FPG at week 20||-71.671|-72.647|<.0001
71898810|NCT01052012|143321153|SUPERIORITY||LS Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.597||0.1473|TWO_SIDED|95.0|-2.11|0.33|||ANCOVA|With pooled site and treatment group as factors and incision length as a covariate.||||0.33|-2.11|0.1473
71898811|NCT01052012|143321153|SUPERIORITY||LS Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.547||0.0601|TWO_SIDED|95.0|-2.16|0.05|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.05|-2.16|0.0601
71898812|NCT01052012|143321153|SUPERIORITY||LS Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.233||0.1483|TWO_SIDED|95.0|-0.8|0.12|||ANCOVA|with pooled site and treatment group as factors and incision length as a covariate.||||0.12|-0.80|0.1483
71898813|NCT01052012|143321154|SUPERIORITY||Median Difference (Hodge-Lehmann)|-1.0||||0.9901|TWO_SIDED|95.0|-54.5|52.0|||Wilcoxon (Mann-Whitney)|||||52.0|-54.5|0.9901
71815260|NCT01480596|143132181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.909||0.775|TWO_SIDED|95.0|-2.12|1.59|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.|||1.59|-2.12|0.775
71815261|NCT04503096|143132183|OTHER|To monitor safety, paired t-tests were conducted to test for pre- to post-treatment differences in global cognition (i.e., MoCA z-scores).||||||0.725|||||||t-test, 2 sided|||||||0.725
71815262|NCT04503096|143132187|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using HAM-D raw scores.||||||0.605|||||||t-test, 2 sided|||||||.605
71898814|NCT01052012|143321154|SUPERIORITY||Median Difference (Hodge-Lehmann)|-5.0||||0.201|TWO_SIDED|95.0|-14.0|3.4|||Wilcoxon Rank-Sum|||||3.4|-14.0|0.2010
71898815|NCT01052012|143321154|SUPERIORITY||Median Difference (Hodge-Lehmann)|-3.0||||0.5897|TWO_SIDED|95.0|-15.0|8.0|||Wilcoxon Rank-Sum|||||8.0|-15.0|0.5897
71898816|NCT02873715|143321162|SUPERIORITY||Mean Difference (Final Values)|-6.21|||<|0.05|TWO_SIDED|95.0|-10.14|-2.29|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.29|-10.14|<0.05
71898817|NCT02873715|143321163|SUPERIORITY||Mean Difference (Final Values)|-3.97||||0.001|TWO_SIDED|95.0|-5.68|-2.26|||ANCOVA||Results are pooled across 10 multiple imputations and reported as mean (standard error)|||-2.26|-5.68|0.001
71898818|NCT02873715|143321165|SUPERIORITY||Mean Difference (Final Values)|-0.5384||||0.65|TWO_SIDED||||||ANOVA|time x group analysis.||repeated measures analysis of variance for parent delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.65
71898819|NCT02873715|143321165|SUPERIORITY||Mean Difference (Net)|-0.3913||||0.87|TWO_SIDED|||||time x group analysis|ANOVA|||repeated measures analysis of variance for child delay discounting changes from 0 to 24-month. This includes only parents with complete data for both time points and does not exclude based on johnson-bickel rules. Reporting time x group analysis.||||0.87
71898820|NCT01651260|143321199|SUPERIORITY_OR_OTHER||upper probability of failure|0.05||||||||||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.|||||
71922604|NCT03370133|143365469|SUPERIORITY||Odds Ratio (OR)|123.02|||<|0.001|TWO_SIDED|95.0|29.394|514.862||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||514.862|29.394|<0.001
71922605|NCT03370133|143365469|SUPERIORITY||Odds Ratio (OR)|18.202|||<|0.001|TWO_SIDED|95.0|10.998|30.123||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||30.123|10.998|<0.001
71678697|NCT04594941|142875566|OTHER||LS Mean Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.854||0.3852|TWO_SIDED|90.0|-2.204|0.698|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||0.698|-2.204|0.3852
71678698|NCT04594941|142875566|OTHER||LS Mean Difference|-0.091|STANDARD_ERROR_OF_MEAN|0.968||0.926|TWO_SIDED|90.0|-1.735|1.554|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.554|-1.735|0.9260
71678699|NCT04594941|142875567|OTHER||LS Mean Difference|-0.219|STANDARD_ERROR_OF_MEAN|1.109||0.8452|TWO_SIDED|90.0|-2.104|1.667|||Mixed-effects model for repeated measure|||"Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.667|-2.104|0.8452
71678700|NCT04594941|142875567|OTHER||Least Square Mean (LSM) Difference|-0.023|STANDARD_ERROR_OF_MEAN|1.63||0.989|TWO_SIDED|90.0|-2.793|2.747|||Mixed-effects model for repeated measure|||"Reader 1: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.747|-2.793|0.9890
71678701|NCT04594941|142875567|OTHER||LS Mean Difference|-1.107|STANDARD_ERROR_OF_MEAN|1.256||0.3852|TWO_SIDED|90.0|-3.241|1.027|||Mixed-effects model for repeated measure|||"Reader 2: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||1.027|-3.241|0.3852
71678702|NCT04594941|142875567|OTHER||LS Mean Difference|-0.133|STANDARD_ERROR_OF_MEAN|1.424||0.926|TWO_SIDED|90.0|-2.552|2.285|||Mixed-effects model for repeated measure|||"Reader 3: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect."||2.285|-2.552|0.9260
71898821|NCT02986958|143321250|OTHER|We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.08||0.046|TWO_SIDED||||||t-test, 2 sided|||||||0.046
71898822|NCT01605396|143321268|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.565|TWO_SIDED|80.0|0.81|1.72|||Regression, Cox|||Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||1.72|0.81|0.565
71898823|NCT01605396|143321270|OTHER||Difference of Percentages|-10.0||||0.267|TWO_SIDED|95.0|-27.8|8.0|||Miettinen and Nurminen's Method|||Miettinen and Nurminen's method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.||8.0|-27.8|0.267
71898824|NCT01605396|143321271|OTHER||Hazard Ratio (HR)|1.38||||0.562|TWO_SIDED|95.0|0.46|4.13|||Regression, Cox|||HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).||4.13|0.46|0.562
71898825|NCT03151148|143321278|SUPERIORITY||Risk Ratio (RR)|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.06|0.29|0.075
71898826|NCT03151148|143321279|SUPERIORITY||Risk Difference (RD)|-0.28||||0.044|TWO_SIDED|95.0|-0.51|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.51|0.044
71898827|NCT03151148|143321280|SUPERIORITY||Risk Ratio (RR)|0.63||||0.121|TWO_SIDED|95.0|0.36|1.13|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator|||1.13|0.36|0.121
71678703|NCT04594941|142875568|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||<0.0001
71678704|NCT04594941|142875568|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
71678705|NCT04594941|142875568|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
71678706|NCT04594941|142875568|OTHER|||||||0.0072|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0072
71678707|NCT04594941|142875568|OTHER|||||||0.0051|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0051
71678708|NCT04594941|142875568|OTHER|||||||0.0023|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0023
71678709|NCT04594941|142875568|OTHER|||||||0.0002|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0002
71678710|NCT04594941|142875568|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
71678711|NCT04594941|142875568|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
71678712|NCT04594941|142875569|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0089
71678713|NCT04594941|142875569|OTHER|||||||0.0207|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0207
71678714|NCT04594941|142875569|OTHER|||||||0.0089|||||||Wilcoxon Signed Rank Test|||Reader 3||||0.0089
71678715|NCT04594941|142875569|OTHER|||||||0.732|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.732
71898828|NCT03151148|143321281|SUPERIORITY||Risk Difference (RD)|-0.25||||0.053|TWO_SIDED|95.0|-0.46|-0.04|||Chi-squared||95% exact unconditional confidence interval is based on the Santner and Snell method|||-0.04|-0.46|0.053
71815263|NCT04503096|143132188|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in depression using GDS raw scores.||||||0.897|||||||t-test, 2 sided|||||||.897
71815264|NCT04503096|143132189|OTHER|Paired t-tests were conducted to test for pre- to post-treatment changes in cognition using Fluid Cognition Composite Scores.|||||<|0.001|||||||t-test, 2 sided|||||||< .001
71815265|NCT03541044|143132245|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 - 1.25 range.|Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.91|1.0|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)|||1.00|0.91|
71815266|NCT03541044|143132246|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for AUC(0-inf) fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||1.00|0.89|
71815267|NCT03541044|143132247|EQUIVALENCE|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the 0.80 - 1.25 range.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.82|0.98|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)|||0.98|0.82|
71815268|NCT04146896|143132283|SUPERIORITY|||||||0.704|||||||t-test, 2 sided|||||||0.704
71815269|NCT04146896|143132284|SUPERIORITY|||||||0.684|||||||t-test, 2 sided|||||||.684
71815270|NCT04146896|143132285|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||||||0.743
71815271|NCT04146896|143132286|SUPERIORITY|||||||0.483|||||||t-test, 2 sided|||||||.483
71815272|NCT04146896|143132287|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||.199
71815273|NCT04146896|143132288|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||||||.273
71815274|NCT04146896|143132289|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||.668
71815275|NCT02118337|143132294|SUPERIORITY||Rate difference|-23.8||||0.5494|TWO_SIDED|95.0|-72.8|31.1|||Fisher Exact|||||31.1|-72.8|0.5494
71815276|NCT02118337|143132294|SUPERIORITY||Rate difference|-7.1||||0.513|TWO_SIDED|95.0|-33.6|20.0|||Fisher Exact|||||20.0|-33.6|0.5130
71815277|NCT00717314|143132330|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
71815278|NCT00717314|143132333|SUPERIORITY_OR_OTHER|||||||0.374|||||||ANOVA|||Between group comparison at Baseline||||0.374
71815279|NCT00717314|143132333|SUPERIORITY_OR_OTHER|||||||0.685||||||Analysis of covariance (ANCOVA) model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.685
71815280|NCT00717314|143132333|SUPERIORITY_OR_OTHER|||||||0.722||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.722
71815281|NCT00717314|143132333|SUPERIORITY_OR_OTHER|||||||0.432||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.432
71815282|NCT00717314|143132334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-5.342|5.561||||||||5.561|-5.342|
71815283|NCT00717314|143132335|SUPERIORITY_OR_OTHER|||||||0.616||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 16||||0.616
71815284|NCT00717314|143132335|SUPERIORITY_OR_OTHER|||||||0.334||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 28||||0.334
71815285|NCT00717314|143132335|SUPERIORITY_OR_OTHER|||||||0.267||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.|ANCOVA|||Change from Baseline at Week 40||||0.267
71815286|NCT00717314|143132335|SUPERIORITY_OR_OTHER|||||||0.764|||||||ANCOVA|ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment\*study center as factors.||Change from Baseline at Week 52||||0.764
71815287|NCT00717314|143132336|SUPERIORITY_OR_OTHER|||||||1|||||||ANCOVA|||||||1.000
71815288|NCT01874145|143132357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.501|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.338|0.743||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group.|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.743|0.338|0.0006
71815289|NCT01874145|143132359|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5|STANDARD_ERROR_OF_MEAN|0.101||0.0006|TWO_SIDED|95.0|0.337|0.742||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.||0.742|0.337|0.0006
71815290|NCT01874145|143132360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.058|STANDARD_ERROR_OF_MEAN|1.206||0.0897|TWO_SIDED|95.0|-4.438|0.322||The overall significance level for this study was 5% using 2-tailed test.|ANCOVA|In addition to treatment group, month (categorical), treatment-by-month interaction and score at baseline were used as covariates.|GA 40 mg/mL TIW treatment group vs. GA 20 mg/mL QD treatment group.|"To control for type 1 errors, secondary variables were analyzed only if analysis of the primary variable was statistically significant. Gate-keeping procedures offered further control with this hierarchy:~1. the rate of ISRs~2. change from baseline to month 4 (change - M4) in MSIS-20 physical wellbeing~3. change - M4 in MSIS-20 psychological wellbeing~4. change - M4 in TSQM-9 convenience~5. change - M4 in TSQM-9 overall satisfaction"||0.322|-4.438|0.0897
71815291|NCT00402337|143132376|SUPERIORITY_OR_OTHER|||||||0.0337||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0337
71815292|NCT00402337|143132376|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||0.0010
71898829|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|2.76||||0.261|TWO_SIDED|95.0|0.469|16.226|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.226|0.469|0.261
71898830|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|0.41||||0.319|TWO_SIDED|95.0|0.069|2.393|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.393|0.069|0.319
71898831|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|1.02||||0.978|TWO_SIDED|95.0|0.174|6.027|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.027|0.174|0.978
71898832|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|3.44||||0.177|TWO_SIDED|95.0|0.57|20.749|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.749|0.570|0.177
71898833|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|1.7||||0.558|TWO_SIDED|95.0|0.288|9.973|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.973|0.288|0.558
71898834|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|1.04||||0.977|TWO_SIDED|95.0|0.082|13.151|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.151|0.082|0.977
71678716|NCT04594941|142875569|OTHER|||||||0.0083|||||||Wilcoxon Signed Rank Test|||Reader 2||||0.0083
71815293|NCT00402337|143132376|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
71678717|NCT04594941|142875569|OTHER|||||||0.0412|||||||Wilcoxon (Mann-Whitney)|||Reader 3||||0.0412
71678718|NCT04594941|142875569|OTHER|||||||0.0001|||||||Wilcoxon Signed Rank Test|||Reader 1||||0.0001
71678719|NCT04594941|142875569|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 2||||<0.0001
71678720|NCT04594941|142875569|OTHER||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Reader 3||||<0.0001
71678721|NCT04594941|142875571|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|1.0000|
71815294|NCT00402337|143132376|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.||||<0.0001
71815295|NCT02821819|143132415|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|8.1||0.8|ONE_SIDED|||||a priori threshold for statistical significance: \<0.05|t-test, 1 sided|||The sample size was calculated assuming a non-inferiority margin of 5 eggs and a standard deviation (SD) of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|"Since the number of collected eggs constitutes the main outcome of the study, the sample size was calculated assuming a non-inferiority margin of 5 eggs with an standard deviation of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).~Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant."|||0.8
71815296|NCT02821819|143132415|NON_INFERIORITY|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|Mean Difference (Final Values)|82.0||||0.8|TWO_SIDED|||||a priori threshold for statistical significance: \<0.05|Chi-squared|||The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.||||0.8
71815297|NCT02821819|143132416|NON_INFERIORITY|Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of \<.05 was considered significant.|Median Difference (Final Values)|71.1|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71815298|NCT00085202|143132426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8001||95.0|||||Log Rank|||||||0.8001
71815299|NCT00085202|143132426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||95.0|||||Log Rank|||||||0.5195
71815300|NCT00085202|143132426|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7696||95.0|||||Log Rank|||||||0.7696
71815301|NCT00085202|143132427|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0206||95.0|||||Log Rank|||||||0.0206
71815302|NCT00085202|143132429|SUPERIORITY|||||||0.6231|||||||t-test, 2 sided|||Change over time||||0.6231
71847013|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.48||||0.0187|TWO_SIDED|95.0|1.43|15.53||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Work Productivity Loss||15.53|1.43|0.0187
71815303|NCT00085202|143132429|SUPERIORITY|||||||0.572|||||||t-test, 2 sided|||Baseline||||0.5720
71815304|NCT00658138|143132440|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|Mean Difference (Final Values)|0.05||||0.05|||||||Wilcoxon (Mann-Whitney)|||Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.||||0.05
71815305|NCT00658138|143132440|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation done - pilot study|percentage of Alpha values||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis is adhesives are not different in clinical performance at one year||||>0.05
71815306|NCT03238300|143132441|SUPERIORITY||partial eta squared|0.02|||>|0.05|TWO_SIDED|95.0|0.0|0.22||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo)|Mixed Models Analysis|Random intercepts were used||"With 31 participants, the study has 99% power to detect such effects on glutamate levels (calculated based on d =1.13 \[reported in Schmaal et al., 2012\], α = 0.05, two-tailed).~We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline metabolite levels and brain tissue composition \[GM:BM = GM/(GM+WM)\], cannabis use (days), and alcohol use disorder status (Yes/No) were included as covariates."||0.22|0.00|>0.05
71815307|NCT03238300|143132442|SUPERIORITY||||||>|0.05||||||P-value \>0.05 for main effect of medication (N-acetylcysteine vs. placebo) for all ROIs.|Mixed Models Analysis|Random intercepts were used for all models.||Contrast of interest was alcohol beverages vs. non-alcohol beverages. We used linear mixed effects models with random intercepts with medication, visit, and sequence. Baseline reactivity levels for each ROI, cannabis use (days), and an alcohol use covariate (quantity, frequency, AUD status, or AUD severity - depending on which best fit the model) were included as covariates. ROIs included were (left and right hemisphere): amygdala, caudate, insula, putamen, and nucleus accumbens.||||>0.05
71815308|NCT02081950|143132443|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|93.65|||||TWO_SIDED|90.0|87.56|100.16||||||||100.16|87.56|
71815309|NCT02081950|143132444|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|100.46|||||TWO_SIDED|90.0|95.74|105.42||||||||105.42|95.74|
71815310|NCT02081950|143132445|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|101.16|||||TWO_SIDED|90.0|96.32|106.24||||||||106.24|96.32|
71898835|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|33.86||||0.007|TWO_SIDED|95.0|2.672|429.219|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||429.219|2.672|0.007
71847014|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.57|||<|0.001|TWO_SIDED|95.0|3.33|11.8||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Activity Impairment||11.80|3.33|<0.001
71847015|NCT00887224|143208464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.62|||<|0.001|TWO_SIDED|95.0|3.14|12.1||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Activity Impairment||12.10|3.14|<0.001
71847016|NCT03883828|143208465|SUPERIORITY||Multivariable Linear Regression|-0.45||||0.004|TWO_SIDED|95.0|-0.75|-0.15||Two-sided p-values equal to or less than 0.05 were considered statistically significant|Fisher Exact|||||-0.15|-0.75|0.004
71847017|NCT03883828|143208466|SUPERIORITY|||||||0.2||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Symptoms Domain||||||0.20
71847018|NCT03883828|143208466|SUPERIORITY|||||||0.05||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Emotions Domain||||||0.05
71847019|NCT03883828|143208466|SUPERIORITY|||||||0.73||||||A 2-sided P ≤ .05 was considered statistically significant|Wilcoxon (Mann-Whitney)|Functioning Domain||||||0.73
71847020|NCT01429454|143208467|SUPERIORITY||Cox Proportional Hazard|0.36||||0.51|TWO_SIDED||||||Chi-squared|||||||.51
71847021|NCT01429454|143208468|SUPERIORITY||||||>|0.1|||||||Mixed Models Analysis|||||||>0.10
71847022|NCT04938453|143208473|OTHER||Ratio of GLSMs (%)|98.47|STANDARD_ERROR_OF_MEAN|13.9|||TWO_SIDED|90.0|90.87|106.69|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.69|90.87|
71847023|NCT04938453|143208474|OTHER||Ratio of GLSMs (%)|100.29|STANDARD_ERROR_OF_MEAN|29.2|||TWO_SIDED|90.0|85.05|118.24|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||118.24|85.05|
71847024|NCT04938453|143208475|OTHER||Ratio of GLSMs (%)|98.92|STANDARD_ERROR_OF_MEAN|13.8|||TWO_SIDED|90.0|91.35|107.12|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of nintedanib 4 X 25 mg)/(GLSM of nintedanib 1 X 100 mg).~Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of this primary endpoint was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||107.12|91.35|
71847025|NCT03345979|143208500|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71847026|NCT03345979|143208500|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71847027|NCT05553366|143208553|SUPERIORITY|||||||0.0002|||||||ANCOVA|||||||0.0002
71847028|NCT05553366|143208554|SUPERIORITY|||||||0.0016|||||||ANCOVA|||||||0.0016
71847029|NCT05553366|143208555|SUPERIORITY|||||||0.0016|||||||Log Rank|||||||0.0016
71847030|NCT05553366|143208556|SUPERIORITY|||||||0.1315|||||||Log Rank|||||||0.1315
71847031|NCT05553366|143208557|SUPERIORITY|||||||0.0343|||||||Cochran-Mantel-Haenszel|||||||0.0343
71847032|NCT05553366|143208558|SUPERIORITY|||||||0.0014|||||||Pearson's chi-squared test|||||||0.0014
71847033|NCT05553366|143208559|SUPERIORITY|||||||0.0032|||||||ANCOVA|||||||0.0032
71847034|NCT05553366|143208560|SUPERIORITY|||||||0.8592|||||||Log Rank|||||||0.8592
71847035|NCT05553366|143208561|SUPERIORITY|||||||0.9143|||||||Cochran-Mantel-Haenszel|||||||0.9143
71847036|NCT05553366|143208562|SUPERIORITY|||||||0.0205|||||||Wilcoxon rank-sum|||||||0.0205
71847037|NCT00659373|143208649|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.71
71847038|NCT02356198|143208658|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71847039|NCT02356198|143208659|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
71847040|NCT02356198|143208660|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
71847041|NCT02356198|143208661|SUPERIORITY|||||||0.454|||||||Chi-squared|||||||0.454
71847042|NCT02356198|143208662|SUPERIORITY|||||||0.212|||||||Fisher Exact|||||||0.212
71898836|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|11.97||||0.055|TWO_SIDED|95.0|0.945|151.752|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||151.752|0.945|0.055
71898837|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|0.93||||0.957|TWO_SIDED|95.0|0.062|13.875|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.875|0.062|0.957
71898838|NCT03151148|143321286|SUPERIORITY||Geometric mean ratio (GMR)|1.78||||0.654|TWO_SIDED|95.0|0.141|22.607|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||22.607|0.141|0.654
71898839|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|2.722||||0.432|TWO_SIDED|95.0|0.2227|33.2594|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||33.2594|0.2227|0.432
71815311|NCT02081950|143132446|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|94.88|||||TWO_SIDED|90.0|88.49|101.73||||||||101.73|88.49|
71815312|NCT02081950|143132447|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|97.13|||||TWO_SIDED|90.0|89.93|104.91||||||||104.91|89.93|
71815313|NCT02081950|143132448|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|108.84|||||TWO_SIDED|90.0|95.61|123.91||||||||123.91|95.61|
71815314|NCT02081950|143132459|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|Geometric least square mean ratio|102.45|||||TWO_SIDED|90.0|96.31|109.0||||||||109.0|96.31|
71815315|NCT02081950|143132460|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|95.84|||||TWO_SIDED|90.0|79.11|116.11||||||||116.11|79.11|
71815316|NCT02081950|143132462|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|99.54|||||TWO_SIDED|90.0|95.69|103.54||||||||103.54|95.69|
71815317|NCT02081950|143132466|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject.|geometric least square mean ratio|98.36|||||TWO_SIDED|90.0|95.31|101.51||||||||101.51|95.31|
71678722|NCT04594941|142875571|OTHER||Kappa Statistics|0.6957|||||TWO_SIDED|95.0|0.1696|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.1696|
71815318|NCT02081950|143132467|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|111.3|||||TWO_SIDED|90.0|99.73|124.2||||||||124.2|99.73|
71815319|NCT02081950|143132470|OTHER|Results were obtained using a mixed-effects ANOVA with fixed effect of study period and a random effect for subject|geometric least square mean ratio|98.7|||||TWO_SIDED|90.0|93.16|104.57||||||||104.57|93.16|
71815320|NCT02081950|143132471|OTHER||geometric least square mean ratio|103.43|||||TWO_SIDED|90.0|94.5|113.2||||||||113.2|94.5|
71815321|NCT02081950|143132472|OTHER||geometric least square mean ratio|92.92|||||TWO_SIDED|90.0|80.58|107.16||||||||107.16|80.58|
71815322|NCT00110890|143132495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.72|13.36|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||13.36|5.72|<0.001
71815323|NCT00110890|143132496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.38|14.19|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||14.19|5.38|<0.001
71815324|NCT00110890|143132497|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.11|||<|0.001||95.0|2.0|4.84|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||4.84|2.00|<0.001
71678723|NCT04594941|142875571|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
71815325|NCT00110890|143132498|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.93|||<|0.001||95.0|4.65|10.34|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||10.34|4.65|<0.001
71847043|NCT03162614|143208663|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).||72|27|<.001
71847044|NCT03162614|143208663|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|76.0|||<|0.001|TWO_SIDED|95.0|49.0|89.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).||89|49|<.001
71847045|NCT03162614|143208663|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|64.0|||<|0.001|TWO_SIDED|95.0|37.0|79.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).||79|37|<.001
71847046|NCT03162614|143208663|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|TWO_SIDED|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).||72|27|<.001
71847047|NCT03162614|143208663|OTHER|Vaccine efficacy rate was calculated as 100\*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|29.0||||0.009|TWO_SIDED|95.0|6.0|46.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).||46|6|0.009
71847048|NCT00380250|143208678|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117|||||||van Elteren nonparametric test|Adjusted for center||||||0.117
71847049|NCT00380250|143208679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||van Elteren nonparametric test|Adjusted for center||||||0.006
71847050|NCT00380250|143208680|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||van Elteren nonparametric test|Adjusted for center||||||0.050
71847051|NCT00380250|143208681|SUPERIORITY_OR_OTHER_LEGACY|||||||0.159|||||||van Elteren nonparametric test|Adjusted for center||||||0.159
71847052|NCT00380250|143208682|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.378
71847053|NCT00380250|143208683|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588|||||||ANCOVA|Adjusted for clinical site||||||0.588
71847054|NCT00380250|143208684|SUPERIORITY_OR_OTHER_LEGACY|||||||0.029||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||90% statistical power to detect 70.6% improvement in response with lubiprostone||||0.029
71847055|NCT00380250|143208685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.028
71847056|NCT00380250|143208686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.069
71847057|NCT00380250|143208687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.098
71847058|NCT00380250|143208688|SUPERIORITY_OR_OTHER_LEGACY|||||||0.286|||||||van Elteren nonparametric test|Adjusted for center||||||0.286
71847059|NCT00380250|143208689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.337|||||||van Elteren nonparametric test|Adjusted for center||||||0.337
71678724|NCT04594941|142875571|OTHER||Kappa Statistics|0.4615|||||TWO_SIDED|95.0|-0.0699|0.993|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||0.9930|-0.0699|
71847060|NCT00380250|143208690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.334|||||||van Elteren nonparametric test|Adjusted for center||||||0.334
71847061|NCT00380250|143208691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||van Elteren nonparametric test|Adjusted for center||||||0.242
71847062|NCT00380250|143208692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||van Elteren nonparametric test|Adjusted for center||||||0.030
71847063|NCT00380250|143208693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||van Elteren nonparametric test|Adjusted for center||||||0.130
71847064|NCT00380250|143208694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||van Elteren nonparametric test|Adjusted for center||||||0.049
71847065|NCT00380250|143208695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.348|||||||van Elteren nonparametric test|Adjusted for center||||||0.348
71847066|NCT00380250|143208696|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||van Elteren nonparametric test|Adjusted for center||||||0.064
71847067|NCT00380250|143208697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111|||||||van Elteren nonparametric test|||||||0.111
71847068|NCT00380250|143208698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||||||0.144
71815326|NCT00110890|143132499|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.002||95.0|1.26|2.81|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg\^2/dL\^2|||2.81|1.26|0.002
71815327|NCT01975220|143132500|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.98|STANDARD_DEVIATION|5.4|<|0.0001|TWO_SIDED|90.0|97.275|102.751|||ANOVA||Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets'.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).|||102.751|97.275|<0.0001
71815328|NCT01975220|143132500|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|97.09|STANDARD_DEVIATION|6.7|<|0.0001|TWO_SIDED|90.0|93.857|100.436|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.436|93.857|<0.0001
71815329|NCT01975220|143132500|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|100.7|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.28|103.18|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.18|98.28|<0.0001
71815330|NCT01975220|143132501|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|94.65|STANDARD_DEVIATION|28.1||0.0256|TWO_SIDED|90.0|82.29|108.88|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||108.88|82.29|0.0256
71815331|NCT01975220|143132501|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.69|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.25|103.26|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.26|96.25|<0.0001
71815332|NCT01975220|143132501|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|99.76|STANDARD_DEVIATION|24.2||0.002|TWO_SIDED|90.0|88.65|112.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||112.27|88.65|0.0020
71815333|NCT01975220|143132502|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.1|STANDARD_DEVIATION|5.1|<|0.0001|TWO_SIDED|90.0|97.555|102.719|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||102.719|97.555|<0.0001
71815334|NCT01975220|143132502|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.01|STANDARD_DEVIATION|7.0|<|0.0001|TWO_SIDED|90.0|93.622|100.531|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||100.531|93.622|<0.0001
71847069|NCT00380250|143208699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||Cochran-Mantel-Haenszel|Adjusted by pooled center||||||0.168
71815335|NCT01975220|143132502|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|100.78|STANDARD_DEVIATION|4.9|<|0.0001|TWO_SIDED|90.0|98.36|103.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.27|98.36|<0.0001
71815336|NCT01975220|143132503|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|109.07|STANDARD_DEVIATION|17.4||0.0072|TWO_SIDED|90.0|99.892|119.1|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||119.100|99.892|0.0072
71815337|NCT01975220|143132503|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|92.42|STANDARD_DEVIATION|12.5||0.0004|TWO_SIDED|90.0|86.781|98.428|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||98.428|86.781|0.0004
71847070|NCT00380250|143208700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615|||||||van Elteren nonparametic test|Adjusted for center||||||0.615
71847071|NCT00380250|143208701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108|||||||van Elteren nonparametric test|||||||0.108
71847072|NCT00380250|143208702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||van Elteren nonparametric test|||||||0.483
71678725|NCT04594941|142875571|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|1.0000|
71815338|NCT01975220|143132503|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing|Adjusted geometric mean ratio (%)|105.37|STANDARD_DEVIATION|17.7||0.0014|TWO_SIDED|90.0|96.6|114.942|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||114.942|96.600|0.0014
71847073|NCT00380250|143208703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491|||||||van Elteren nonparametric test|||||||0.491
71847074|NCT00380250|143208704|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
71847075|NCT00380250|143208705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
71815339|NCT01975220|143132504|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|96.65|STANDARD_DEVIATION|29.8||0.0198|TWO_SIDED|90.0|83.337|112.079|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||112.079|83.337|0.0198
71815340|NCT01975220|143132504|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|110.17|STANDARD_DEVIATION|12.0||0.0007|TWO_SIDED|90.0|103.809|116.926|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||116.926|103.809|0.0007
71815341|NCT01975220|143132504|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|97.68|STANDARD_DEVIATION|23.8||0.0037|TWO_SIDED|90.0|86.942|109.734|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||109.734|86.942|0.0037
71815342|NCT01975220|143132505|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|95.4|STANDARD_DEVIATION|29.4||0.0254|TWO_SIDED|90.0|82.42|110.44|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).|||110.44|82.42|0.0254
71815343|NCT01975220|143132505|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|99.63|STANDARD_DEVIATION|7.1|<|0.0001|TWO_SIDED|90.0|96.21|103.17|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||103.17|96.21|<0.0001
71815344|NCT01975220|143132505|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing.|Adjusted geometric mean ratio (%)|101.06|STANDARD_DEVIATION|24.4||0.0029|TWO_SIDED|90.0|89.7|113.86|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."|||113.86|89.70|0.0029
71815345|NCT04064242|143132537|OTHER|A Bayesian model for repeated measurements including data collected at Weeks 4, 8, 12 and 16 was applied to compare FVC between CMK389 and placebo groups.|Posterior estimate treatment difference|-1.49|STANDARD_DEVIATION|1.62||0.1804|TWO_SIDED|80.0|-3.56|0.6|||Bayesian analysis|Posterior probability that treatment is better than placebo.|80% credible intervals are reported on the treatment difference|||0.60|-3.56|0.1804
71815346|NCT04064242|143132543|SUPERIORITY||Median Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.045||0.783|TWO_SIDED|80.0|-0.09|0.02|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.02|-0.09|0.783
71847076|NCT00380250|143208706|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center||||||<0.001
71815347|NCT04064242|143132544|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.664||0.608|TWO_SIDED|80.0|-1.05|0.68|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||0.68|-1.05|0.608
71815348|NCT04064242|143132545|SUPERIORITY||Median Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|13.126||0.479|TWO_SIDED|80.0|-16.35|17.76|||Mixed effects Model for Repeated Measure||Treatment difference (CMK389-placebo)|||17.76|-16.35|0.479
71815349|NCT03857230|143132568|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline AUC0-192 were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|93.31||||0.05|TWO_SIDED|90.0|87.25|99.79|||ANOVA|||Statistical comparison of the obtained results comprised the calculation of parametric bilateral 90 % CIs for the ratios of the corresponding mean values of the pharmacokinetic parameters of the study and comparator drug. The equivalence of the pharmacokinetics of the drug products will be proven if the limits of the evaluated CIs for the ratios of the mean values are in the range of 80.00-125.00%.||99.79|87.25|0.05
71815350|NCT03857230|143132569|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed baseline Cmax were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|87.93||||0.05|TWO_SIDED|90.0|82.85|93.33|||ANOVA|||||93.33|82.85|0.05
71815351|NCT03021668|143132573|EQUIVALENCE|Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups||||||0.003|||||||Chi-squared|||||||0.003
71847077|NCT01321073|143208762|SUPERIORITY||||||<|0.0001|||||||1-sample exact test for Poisson rate|||The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.||||<0.0001
71922606|NCT03370133|143365470|SUPERIORITY||Odds Ratio (OR)|16.258|||<|0.001|TWO_SIDED|95.0|7.356|35.931||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||35.931|7.356|<0.001
71922607|NCT03370133|143365471|SUPERIORITY||Odds Ratio (OR)|22.279|||<|0.001|TWO_SIDED|95.0|9.795|50.674||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||50.674|9.795|<0.001
71815352|NCT03021668|143132574|EQUIVALENCE|Students' T-test was used to evaluate any difference in length of stay between the two groups.||||||0.23|||||||t-test, 2 sided|||||||0.23
71815353|NCT00909428|143132577|SUPERIORITY||Z-Score|2.803||||0.005|TWO_SIDED||||||Wilcoxon signed rank test|||The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.||||.005
71815354|NCT03535337|143132581|SUPERIORITY||Slope|2.44|STANDARD_ERROR_OF_MEAN|1.1||0.03|TWO_SIDED|95.0|0.28|4.59|||Mixed Models Analysis|||||4.59|0.28|0.03
71847078|NCT01638000|143208765|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was \> -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.|least squares mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.124||0.15|TWO_SIDED|95.0|-0.42|0.06||If p\<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.||0.06|-0.42|0.15
71847079|NCT01638000|143208766|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.25||If P \<0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.|Regression, Logistic|Included treatment group, sex, age group (\< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.||Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.||2.25|1.04|0.030
71847080|NCT01638000|143208767|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.117||0.71|TWO_SIDED|95.0|-0.19|0.27||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.27|-0.19|0.71
71847081|NCT01638000|143208767|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.119||0.053|TWO_SIDED|95.0|-0.47|0.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.47|0.053
71847082|NCT01638000|143208767|SUPERIORITY_OR_OTHER_LEGACY||least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.125||0.12|TWO_SIDED|95.0|-0.44|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.44|0.12
71847083|NCT01638000|143208768|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.9||||0.33|TWO_SIDED|95.0|0.73|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron.||1.11|0.73|0.33
71847084|NCT01638000|143208768|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.84||||0.21|TWO_SIDED|95.0|0.64|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron.||1.10|0.64|0.21
71847085|NCT01638000|143208768|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.83|TWO_SIDED|95.0|0.71|1.32||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron.||1.32|0.71|0.83
71847086|NCT01638000|143208768|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.57|TWO_SIDED|95.0|0.68|1.24||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.24|0.68|0.57
71898840|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|0.147||||0.133|TWO_SIDED|95.0|0.0121|1.8018|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.8018|0.0121|0.133
71922608|NCT03370133|143365472|SUPERIORITY||Odds Ratio (OR)|23.049|||<|0.001|TWO_SIDED|95.0|10.201|52.077||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||52.077|10.201|<0.001
71922609|NCT03370133|143365473|SUPERIORITY||Odds Ratio (OR)|37.696|||<|0.001|TWO_SIDED|95.0|16.92|83.987||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables. Logit method was used where CMH test not possible due to very low response.||83.987|16.920|<0.001
71922610|NCT03370133|143365474|SUPERIORITY||Odds Ratio (OR)|8.047|||<|0.001|TWO_SIDED|95.0|5.107|12.679||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||12.679|5.107|<0.001
71847087|NCT01638000|143208769|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.089||0.36|TWO_SIDED|95.0|-0.25|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.25|0.36
71847088|NCT01638000|143208769|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.13||0.12|TWO_SIDED|95.0|-0.48|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.48|0.12
71847089|NCT01638000|143208769|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.163||0.47|TWO_SIDED|95.0|-0.57|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.07|-0.57|0.47
71847090|NCT01638000|143208770|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.92||||0.44|TWO_SIDED|95.0|0.74|1.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.14|0.74|0.44
71847091|NCT01638000|143208770|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.79||||0.11|TWO_SIDED|95.0|0.6|1.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 8 Rate Ratio vs. Mirabegron||1.06|0.60|0.11
71847092|NCT01638000|143208770|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.78|TWO_SIDED|95.0|0.76|1.45||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron||1.45|0.76|0.78
71847093|NCT01638000|143208770|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|0.97||||0.85|TWO_SIDED|95.0|0.71|1.33||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Final Visit Rate Ratio vs. Mirabegron||1.33|0.71|0.85
71922315|NCT00453349|143365043|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-7.9||||||95.0|-24.9|15.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||15.9|-24.9|
71847094|NCT01638000|143208771|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.081||0.66|TWO_SIDED|95.0|-0.18|0.14||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.14|-0.18|0.66
71847095|NCT01638000|143208771|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.17|TWO_SIDED|95.0|-0.31|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.03|-0.31|0.17
71847096|NCT01638000|143208771|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.066||0.66|TWO_SIDED|95.0|-0.24|0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.02|-0.24|0.66
71847097|NCT01638000|143208772|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.19|-0.44|0.43
71847098|NCT01638000|143208772|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.157||0.027|TWO_SIDED|95.0|-0.66|-0.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||-0.04|-0.66|0.027
71922316|NCT00453349|143365044|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|3.7||||||95.0|-30.5|11.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||11.9|-30.5|
71847099|NCT01638000|143208772|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.164||0.053|TWO_SIDED|95.0|-0.64|0.0|||ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.00|-0.64|0.053
71847100|NCT01638000|143208772|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.163||0.16|TWO_SIDED|95.0|-0.55|0.09||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.09|-0.55|0.16
71847101|NCT01638000|143208773|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.99|TWO_SIDED|95.0|-0.05|0.05||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.05|-0.05|0.99
71847102|NCT01638000|143208773|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.027||0.47|TWO_SIDED|95.0|-0.07|0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.03|-0.07|0.47
71847103|NCT01638000|143208773|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.032||0.99|TWO_SIDED|95.0|-0.06|0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.06|-0.06|0.99
71847104|NCT01638000|143208773|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.031||0.74|TWO_SIDED|95.0|-0.05|0.07||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.07|-0.05|0.74
71847105|NCT01638000|143208774|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.20|0.89|0.67
71847106|NCT01638000|143208774|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.17||||0.073|TWO_SIDED|95.0|0.99|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.39|0.99|0.073
71847107|NCT01638000|143208774|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.12||||0.25|TWO_SIDED|95.0|0.92|1.37||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.37|0.92|0.25
71847108|NCT01638000|143208774|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.08||||0.4|TWO_SIDED|95.0|0.9|1.31||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.31|0.90|0.40
71847109|NCT01638000|143208775|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.115||0.84|TWO_SIDED|95.0|-0.25|0.2||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.20|-0.25|0.84
71847110|NCT01638000|143208775|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.099||0.63|TWO_SIDED|95.0|-0.24|0.15||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.15|-0.24|0.63
71847111|NCT01638000|143208775|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.111||0.59|TWO_SIDED|95.0|-0.28|0.16||if p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.16|-0.28|0.59
71922317|NCT01519648|143365079|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.872|STANDARD_ERROR_OF_MEAN|0.237||0.007|TWO_SIDED|95.0|1.178|2.977|||Chi-squared|||||2.977|1.178|0.007
71847112|NCT01638000|143208776|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.05||||0.068|TWO_SIDED|95.0|1.0|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron||1.11|1.00|0.068
71847113|NCT01638000|143208776|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.04||||0.21|TWO_SIDED|95.0|0.98|1.11||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron||1.11|0.98|0.21
71847114|NCT01638000|143208776|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.02||||0.52|TWO_SIDED|95.0|0.95|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron||1.10|0.95|0.52
71847115|NCT01638000|143208776|SUPERIORITY_OR_OTHER_LEGACY||Rate ratio|1.03||||0.44|TWO_SIDED|95.0|0.96|1.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron||1.10|0.96|0.44
71847116|NCT01638000|143208777|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.047||0.058|TWO_SIDED|95.0|0.0|0.18||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.18|-0.00|0.058
71847117|NCT01638000|143208777|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.044||0.5|TWO_SIDED|95.0|-0.06|0.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.12|-0.06|0.50
71847118|NCT01638000|143208777|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.046||0.81|TWO_SIDED|95.0|-0.08|0.1||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.||0.10|-0.08|0.81
71847119|NCT01638000|143208778|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.67|TWO_SIDED|95.0|0.85|1.28||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds ratio vs. Mirabegron||1.28|0.85|0.67
71678726|NCT04594941|142875571|OTHER||Kappa Statistics|1.0|||||TWO_SIDED|95.0|1.0|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|1.0000|
71898841|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|0.371||||0.437|TWO_SIDED|95.0|0.0304|4.5392|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.5392|0.0304|0.437
71898842|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|1.247||||0.863|TWO_SIDED|95.0|0.1002|15.5231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.5231|0.1002|0.863
71898843|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|0.615||||0.702|TWO_SIDED|95.0|0.0503|7.5106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.5106|0.0503|0.702
71898844|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|0.465||||0.675|TWO_SIDED|95.0|0.0128|16.8576|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||16.8576|0.0128|0.675
71898845|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|32.638||||0.057|TWO_SIDED|95.0|0.8994|1184.4298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1184.4298|0.8994|0.057
71898846|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|11.539||||0.181|TWO_SIDED|95.0|0.318|418.7586|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||418.7586|0.3180|0.181
71898847|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|0.895||||0.953|TWO_SIDED|95.0|0.0219|36.5559|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.5559|0.0219|0.953
71898848|NCT03151148|143321288|SUPERIORITY||Geometric mean ratio (GMR)|1.719||||0.767|TWO_SIDED|95.0|0.0474|62.3828|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||62.3828|0.0474|0.767
71922318|NCT04524663|143365080|SUPERIORITY||Median Difference (Net)|0.59||||0.89|TWO_SIDED|95.0|-8.14|9.32|||Regression, Linear|||||9.32|-8.14|0.89
71922319|NCT04524663|143365081|SUPERIORITY||Median Difference (Net)|18.9||||0.02|TWO_SIDED|95.0|2.98|34.83|||Regression, Linear|||||34.83|2.98|0.02
71678727|NCT04594941|142875571|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 1||1.0000|0.6567|
71922320|NCT04524663|143365082|SUPERIORITY||Hazard Ratio (HR)|1.69||||0.24|TWO_SIDED|95.0|0.7|4.1|||Cox proportional hazards model|||||4.10|0.70|0.24
71678728|NCT04594941|142875571|OTHER||Kappa Statistics|0.8828|||||TWO_SIDED|95.0|0.6614|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 2||1.0000|0.6614|
71898849|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|1.395||||0.488|TWO_SIDED|95.0|0.5429|3.5835|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.5835|0.5429|0.488
71898850|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|2.823||||0.03|TWO_SIDED|95.0|1.1038|7.221|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.2210|1.1038|0.030
71898851|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|2.077||||0.127|TWO_SIDED|95.0|0.8122|5.3135|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.3135|0.8122|0.127
71898852|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|0.789||||0.623|TWO_SIDED|95.0|0.3065|2.0331|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.0331|0.3065|0.623
71898853|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|0.627||||0.328|TWO_SIDED|95.0|0.245|1.6028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6028|0.2450|0.328
71898854|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|2.231||||0.242|TWO_SIDED|95.0|0.5799|8.5866|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.5866|0.5799|0.242
71898855|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|1.977||||0.321|TWO_SIDED|95.0|0.5137|7.6055|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.6055|0.5137|0.321
71898856|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|1.86||||0.366|TWO_SIDED|95.0|0.4833|7.1564|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.1564|0.4833|0.366
71922321|NCT04524663|143365083|SUPERIORITY|||||||0.49|||||||Fisher Exact|||||||0.49
71922322|NCT04524663|143365084|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.24|TWO_SIDED|95.0|0.32|1.33|||Cox proportional hazards model|||||1.33|0.32|0.24
71922323|NCT00337935|143365087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0062|TWO_SIDED|95.0|0.2|0.9||a priori theshold for statistical significance was p=0.05|ANCOVA|Baseline Hemoglobin was used as a covariate.||||0.9|0.2|.0062
71922324|NCT00337935|143365088|SUPERIORITY_OR_OTHER||||||<|0.001||||||A priori threshold for statistical significance p=0.05|Chi-squared|||||||<0.001
71922325|NCT00337935|143365089|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A priori threshold for statistical significance p=0.05|Log Rank|||||||<0.0001
71922326|NCT02361307|143365108|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71898857|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|3.713||||0.068|TWO_SIDED|95.0|0.908|15.1856|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.1856|0.9080|0.068
71847120|NCT01638000|143208778|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.026|TWO_SIDED|95.0|1.03|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds ratio vs. Mirabegron||1.53|1.03|0.026
71898858|NCT03151148|143321290|SUPERIORITY||Geometric mean ratio (GMR)|2.858||||0.13|TWO_SIDED|95.0|0.7328|11.1434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||11.1434|0.7328|0.130
71898859|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|3.16||||0.233|TWO_SIDED|95.0|0.476|20.952|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||20.952|0.476|0.233
71898860|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.08||||0.008|TWO_SIDED|95.0|0.012|0.514|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.514|0.012|0.008
71898861|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.298|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.298|0.007|0.001
71678729|NCT04594941|142875571|OTHER||Kappa Statistics|0.8811|||||TWO_SIDED|95.0|0.6567|1.0|||||Kappa statistics was assessed using Cohen's kappa statistics.|Reader 3||1.0000|0.6567|
71678730|NCT03535194|142875578|SUPERIORITY||Risk Difference (RD)|73.5|||<|0.001|TWO_SIDED|95.0|68.2|78.7|||Cochran-Mantel-Haenszel|||||78.7|68.2|<0.001
71847121|NCT01638000|143208778|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.11|TWO_SIDED|95.0|0.97|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds ratio vs. Mirabegron||1.44|0.97|0.11
71847122|NCT01638000|143208778|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.093|TWO_SIDED|95.0|0.97|1.43||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final Visit Odds ratio vs. Mirabegron||1.43|0.97|0.093
71847123|NCT01638000|143208779|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.06||||0.74|TWO_SIDED|95.0|0.76|1.48||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.48|0.76|0.74
71847124|NCT01638000|143208779|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.74|TWO_SIDED|95.0|0.71|1.63||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.63|0.71|0.74
71847125|NCT01638000|143208779|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.29|TWO_SIDED|95.0|0.81|2.0||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||2.00|0.81|0.29
71847126|NCT01638000|143208779|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.29|TWO_SIDED|95.0|0.82|1.9||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.90|0.82|0.29
71847127|NCT01638000|143208780|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.2|TWO_SIDED|95.0|0.9|1.67||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron||1.67|0.90|0.20
71847128|NCT01638000|143208780|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91||||0.57|TWO_SIDED|95.0|0.65|1.26||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron||1.26|0.65|0.57
71847129|NCT01638000|143208780|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.92|TWO_SIDED|95.0|0.69|1.39||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.39|0.69|0.92
71847130|NCT01638000|143208780|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.73|1.42||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.42|0.73|0.90
71847131|NCT01638000|143208801|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.69|STANDARD_ERROR_OF_MEAN|0.817||0.039|TWO_SIDED|95.0|-3.29|-0.08||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.08|-3.29|0.039
71847132|NCT01638000|143208801|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.849||0.034|TWO_SIDED|95.0|-3.46|-0.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.13|-3.46|0.034
71847133|NCT01638000|143208801|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.917||0.022|TWO_SIDED|95.0|-3.9|-0.3||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.30|-3.90|0.022
71847134|NCT01638000|143208801|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.924||0.043|TWO_SIDED|95.0|-3.68|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-3.68|0.043
71847135|NCT01638000|143208802|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.14|STANDARD_ERROR_OF_MEAN|0.77||0.14|TWO_SIDED|95.0|-0.37|2.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||2.65|-0.37|0.14
71847136|NCT01638000|143208802|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.805||0.055|TWO_SIDED|95.0|-0.03|3.13||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.13|-0.03|0.055
71922611|NCT03370133|143365475|SUPERIORITY||Odds Ratio (OR)|3.795|||<|0.001|TWO_SIDED|95.0|2.442|5.899||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||5.899|2.442|<0.001
71922612|NCT03370133|143365476|SUPERIORITY||Odds Ratio (OR)|4.379|||<|0.001|TWO_SIDED|95.0|2.85|6.73||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||6.730|2.850|<0.001
71922613|NCT03370133|143365477|SUPERIORITY||Odds Ratio (OR)|2.412|||<|0.001|TWO_SIDED|95.0|1.573|3.699||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||3.699|1.573|<0.001
71678731|NCT03535194|142875579|SUPERIORITY||Risk Difference (RD)|68.0|||<|0.001|TWO_SIDED|95.0|62.7|73.3|||Cochran-Mantel-Haenszel|||||73.3|62.7|<0.001
71847137|NCT01638000|143208802|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.55|STANDARD_ERROR_OF_MEAN|0.866||0.074|TWO_SIDED|95.0|-0.15|3.25||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.25|-0.15|0.074
71847138|NCT01638000|143208802|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.41|STANDARD_ERROR_OF_MEAN|0.873||0.11|TWO_SIDED|95.0|-0.3|3.12||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||3.12|-0.30|0.11
71847139|NCT01638000|143208803|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.07|TWO_SIDED|95.0|-0.19|0.01||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.01|-0.19|0.070
71847140|NCT01638000|143208803|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.054||0.003|TWO_SIDED|95.0|-0.27|-0.06||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.06|-0.27|0.003
71847141|NCT01638000|143208803|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.06||0.015|TWO_SIDED|95.0|-0.26|-0.03||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.03|-0.26|0.015
71847142|NCT01638000|143208803|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.059||0.021|TWO_SIDED|95.0|-0.25|-0.02||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||-0.02|-0.25|0.021
71847143|NCT01638000|143208804|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.141||0.002|TWO_SIDED|95.0|0.15|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.15|0.002
71847144|NCT01638000|143208804|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.141||0.003|TWO_SIDED|95.0|0.14|0.7||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.70|0.14|0.003
71847145|NCT01638000|143208805|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean diffrence|0.16|STANDARD_ERROR_OF_MEAN|0.07||0.027|TWO_SIDED|95.0|0.02|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.02|0.027
71847146|NCT01638000|143208805|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.071||0.034|TWO_SIDED|95.0|0.01|0.29||If p\<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.||0.29|0.01|0.034
71847147|NCT01638000|143208806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.01|TWO_SIDED|95.0|1.08|1.81||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.81|1.08|0.010
71898862|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.651|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.651|0.013|0.017
71898863|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.04||||0.001|TWO_SIDED|95.0|0.007|0.292|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.292|0.007|0.001
71678732|NCT03535194|142875580|SUPERIORITY||Risk Difference (RD)|81.6|||<|0.001|TWO_SIDED|95.0|76.1|87.0|||Cochran-Mantel-Haenszel|||||87.0|76.1|<0.001
71847148|NCT01638000|143208806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.011|TWO_SIDED|95.0|1.07|1.75||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.75|1.07|0.011
71847149|NCT01638000|143208807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.28||||0.037|TWO_SIDED|95.0|1.02|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.62|1.02|0.037
71847150|NCT01638000|143208807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.26||||0.045|TWO_SIDED|95.0|1.01|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.57|1.01|0.045
71847151|NCT01638000|143208808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.009|TWO_SIDED|95.0|1.11|2.06||Iif p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥1 point improvement) Odds Rato vs. Mirabegron||2.06|1.11|0.009
71847152|NCT01638000|143208808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.065|TWO_SIDED|95.0|0.99|1.65||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥2 point improvement) Odds Rato vs. Mirabegron||1.65|0.99|0.065
71847153|NCT01638000|143208808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.051|TWO_SIDED|95.0|1.0|1.55||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥3 point improvement) Odds Rato vs. Mirabegron||1.55|1.00|0.051
71847154|NCT01638000|143208808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.14|TWO_SIDED|95.0|0.95|1.47||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥4 point improvement) Odds Rato vs. Mirabegron||1.47|0.95|0.14
71847155|NCT01638000|143208808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.89|TWO_SIDED|95.0|0.75|1.4||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥5 point improvement) Odds Rato vs. Mirabegron||1.40|0.75|0.89
71847156|NCT01638000|143208808|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Week 12 (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
71847157|NCT01638000|143208809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.016|TWO_SIDED|95.0|1.07|1.93||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥1 point improvement) Odds Rato vs. Mirabegron||1.93|1.07|0.016
71847158|NCT01638000|143208809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.27||||0.063|TWO_SIDED|95.0|0.99|1.62||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥2 point improvement) Odds Rato vs. Mirabegron||1.62|0.99|0.063
71898864|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.358|TWO_SIDED|95.0|0.366|15.967|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.967|0.366|0.358
71678733|NCT03535194|142875581|SUPERIORITY||Risk Difference (RD)|51.7|||<|0.001|TWO_SIDED|95.0|47.6|55.8|||Cochran-Mantel-Haenszel|||||55.8|47.6|<0.001
71847159|NCT01638000|143208809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.054|TWO_SIDED|95.0|1.0|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥3 point improvement) Odds Rato vs. Mirabegron||1.53|1.00|0.054
71847160|NCT01638000|143208809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.15|TWO_SIDED|95.0|0.95|1.46||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥4 point improvement) Odds Rato vs. Mirabegron||1.46|0.95|0.15
71847161|NCT01638000|143208809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.75|TWO_SIDED|95.0|0.77|1.44||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥5 point improvement) Odds Rato vs. Mirabegron||1.44|0.77|0.75
71847162|NCT01638000|143208809|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.66|TWO_SIDED|95.0|0.64|2.04||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Final visit (6 point improvement) Odds Rato vs. Mirabegron||2.04|0.64|0.66
71847163|NCT01638000|143208810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.082|TWO_SIDED|95.0|0.97|1.57||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.57|0.97|0.082
71847164|NCT01638000|143208810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.18||||0.15|TWO_SIDED|95.0|0.94|1.49||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.49|0.94|0.15
71898865|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.1||||0.019|TWO_SIDED|95.0|0.016|0.683|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.683|0.016|0.019
71898866|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.11||||0.023|TWO_SIDED|95.0|0.017|0.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.739|0.017|0.023
71898867|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.09||||0.017|TWO_SIDED|95.0|0.013|0.647|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.647|0.013|0.017
71922614|NCT00684073|143365490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.42||||0.13||95.0||||p-value adjusted for treatment only|ANCOVA||Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.|||||0.130
71898868|NCT03151148|143321291|SUPERIORITY||Geometric mean ratio (GMR)|0.37||||0.299|TWO_SIDED|95.0|0.056|2.436|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.436|0.056|0.299
71898869|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|1.49||||0.538|TWO_SIDED|95.0|0.415|5.38|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|5.380|0.415|0.538
71898870|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.88||||0.849|TWO_SIDED|95.0|0.245|3.18|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.180|0.245|0.849
71847165|NCT01638000|143208811|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.058|TWO_SIDED|95.0|0.99|1.53||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron||1.53|0.99|0.058
71898871|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.4||||0.155|TWO_SIDED|95.0|0.11|1.424|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.424|0.110|0.155
71898872|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.45||||0.242|TWO_SIDED|95.0|0.117|1.722|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.722|0.117|0.242
71898873|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.47||||0.258|TWO_SIDED|95.0|0.129|1.735|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.735|0.129|0.258
71898874|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|1.26||||0.726|TWO_SIDED|95.0|0.349|4.52|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.520|0.349|0.726
71678734|NCT03535194|142875582|SUPERIORITY||Risk Difference (RD)|23.2|||<|0.001|TWO_SIDED|95.0|19.3|27.1|||Cochran-Mantel-Haenszel|||||27.1|19.3|<0.001
71847166|NCT01638000|143208811|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.069|TWO_SIDED|95.0|0.99|1.5||If p\<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI|Regression, Logistic|Treatment group, gender, age group (\<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron||1.50|0.99|0.069
71678735|NCT03535194|142875583|SUPERIORITY||Risk Difference (RD)|53.5|||<|0.001|TWO_SIDED|95.0|47.7|59.3|||Cochran-Mantel-Haenszel|||||59.3|47.7|<0.001
71678736|NCT03535194|142875584|SUPERIORITY||LSMean Difference|-4.94|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|-7.01|-2.88|||Mixed Models Analysis|||||-2.88|-7.01|<0.001
71678737|NCT03535194|142875585|SUPERIORITY||LSMean Difference|-15.15|STANDARD_ERROR_OF_MEAN|0.692|<|0.001|TWO_SIDED|95.0|-16.51|-13.8|||Mixed Models Analysis|||||-13.80|-16.51|<0.001
71847167|NCT04218864|143208826|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Linear Mixed regression models (LMM) have been used to identify any difference between the intervention and the control groups over time with regards to the continuous outcomes. Group (intervention vs. control), a 5-category time (baseline, 6 week, 3 month, 6 month, 12 month) and group-by-time interaction are covariates in the model. A random subject intercept is used to account for clustering within subject.||||>0.05
71847168|NCT04218864|143208827|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
71847169|NCT04218864|143208828|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for the primary outcome.||||>0.05
71847170|NCT04218864|143208829|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical analysis strategy is identical to that for primary outcome.||||>0.05
71847171|NCT04218864|143208830|SUPERIORITY||||||>|0.05||||||Threshold for statistical significance = 0.05|Regression, Linear|Results presented are unadjusted for any covariates.||Statistical Analysis strategy is identical to that for primary outcome measure.||||>0.05
71847172|NCT00145470|143208873|SUPERIORITY|||||||0.0257||||||P-value based on the difference in the least squares (LS) means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0257
71847173|NCT00145470|143208876|SUPERIORITY|||||||0.021||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 42||||0.0210
71847174|NCT00145470|143208877|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0073
71847175|NCT00145470|143208878|SUPERIORITY|||||||0.3928|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3928
71847176|NCT00145470|143208878|SUPERIORITY|||||||0.7923|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.7923
71898875|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.32||||0.08|TWO_SIDED|95.0|0.088|1.145|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.145|0.088|0.080
71678738|NCT03535194|142875586|SUPERIORITY||LSMean Difference|-9.59|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-12.63|-6.55|||Mixed Models Analysis|||||-6.55|-12.63|<0.001
71678739|NCT03535194|142875587|SUPERIORITY||LSMean Difference|3.46|STANDARD_ERROR_OF_MEAN|0.642|<|0.001|TWO_SIDED|95.0|2.2|4.72|||ANCOVA|||||4.72|2.20|<0.001
71847177|NCT00145470|143208878|SUPERIORITY|||||||0.0701|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.0701
71847178|NCT00145470|143208878|SUPERIORITY|||||||0.1634|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.1634
71847179|NCT00145470|143208878|SUPERIORITY|||||||0.037|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0370
71847180|NCT00145470|143208878|SUPERIORITY|||||||0.0488|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0488
71847181|NCT00145470|143208878|SUPERIORITY|||||||0.0152|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0152
71847182|NCT00145470|143208879|SUPERIORITY|||||||0.3709|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 3||||0.3709
71847183|NCT00145470|143208879|SUPERIORITY|||||||0.8837|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 7||||0.8837
71847184|NCT00145470|143208879|SUPERIORITY|||||||0.1153|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 14||||0.1153
71847185|NCT00145470|143208879|SUPERIORITY|||||||0.0158|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 21||||0.0158
71847186|NCT00145470|143208879|SUPERIORITY|||||||0.0143|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 42||||0.0143
71847187|NCT00145470|143208879|SUPERIORITY|||||||0.0196|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 63||||0.0196
71847188|NCT00145470|143208879|SUPERIORITY|||||||0.0148|||||||Chi-squared|Based on Pearson's chi-squared test.||Day 84||||0.0148
71678740|NCT03535194|142875588|SUPERIORITY||LSMean Difference|3.96|STANDARD_ERROR_OF_MEAN|0.711|<|0.001|TWO_SIDED|95.0|2.56|5.35|||ANCOVA|||||5.35|2.56|<0.001
71847189|NCT00145470|143208880|SUPERIORITY|||||||0.0046||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0046
71847190|NCT00145470|143208881|SUPERIORITY|||||||0.0006||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0006
71847191|NCT00145470|143208882|SUPERIORITY|||||||0.3497||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3497
71847192|NCT00145470|143208883|SUPERIORITY|||||||0.7753||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.7753
71847193|NCT00145470|143208884|SUPERIORITY|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.0073
71847194|NCT00145470|143208885|SUPERIORITY|||||||0.0102||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.0102
71847195|NCT00145470|143208886|SUPERIORITY|||||||0.3684||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.3684
71847196|NCT00145470|143208887|SUPERIORITY|||||||0.937||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9370
71847197|NCT00145470|143208888|SUPERIORITY|||||||0.2492||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.2492
71847198|NCT00145470|143208889|SUPERIORITY|||||||0.4683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4683
71847199|NCT00145470|143208890|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.5683
71847200|NCT00145470|143208891|SUPERIORITY|||||||0.9693||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.9693
71847201|NCT00145470|143208892|SUPERIORITY|||||||0.6136||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.6136
71678741|NCT03535194|142875589|SUPERIORITY||Risk Difference (RD)|65.0|||<|0.001|TWO_SIDED|95.0|59.3|70.8|||Cochran-Mantel-Haenszel|||||70.8|59.3|<0.001
71678742|NCT03535194|142875591|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.255||0.826|TWO_SIDED|95.0|-4.96|3.96|||ANCOVA|||||3.96|-4.96|0.826
71847202|NCT00145470|143208893|SUPERIORITY|||||||0.1586||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.1586
71678743|NCT03535194|142875593|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|3.3|||<|0.0001|TWO_SIDED|95.0|-1.4|7.9|||Cochran-Mantel-Haenszel|||||7.9|-1.4|<0.0001
71678744|NCT03535194|142875594|NON_INFERIORITY|10% non-inferiority margin was used.|Risk Difference (RD)|1.6|||<|0.0001|TWO_SIDED|95.0|-3.4|6.6|||Cochran-Mantel-Haenszel|||||6.6|-3.4|<0.0001
71678745|NCT02091375|142875615|SUPERIORITY||Median Difference (Final Values)|-22.79||||0.0123|TWO_SIDED|95.0|-41.06|-5.43|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach.|||-5.43|-41.06|0.0123
71847203|NCT00145470|143208894|SUPERIORITY|||||||0.055||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 21||||0.0550
71847204|NCT00145470|143208894|SUPERIORITY|||||||0.7469||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 21||||0.7469
71847205|NCT00145470|143208894|SUPERIORITY|||||||0.3253||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 21||||0.3253
71847206|NCT00145470|143208894|SUPERIORITY|||||||0.3885||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 21||||0.3885
71847207|NCT00145470|143208894|SUPERIORITY|||||||0.5975||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 21||||0.5975
71847208|NCT00145470|143208894|SUPERIORITY|||||||0.069||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 21||||0.0690
71898876|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.81||||0.748|TWO_SIDED|95.0|0.225|2.917|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.917|0.225|0.748
71898877|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|1.23||||0.76|TWO_SIDED|95.0|0.327|4.617|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.617|0.327|0.760
71898878|NCT03151148|143321292|SUPERIORITY||Geometric mean ratio (GMR)|0.79||||0.713|TWO_SIDED|95.0|0.219|2.832|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.832|0.219|0.713
71898879|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|12.08|||<|0.001|TWO_SIDED|95.0|3.524|41.435|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||41.435|3.524|<0.001
71898880|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|2.58||||0.131|TWO_SIDED|95.0|0.753|8.853|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.853|0.753|0.131
71847209|NCT00145470|143208894|SUPERIORITY|||||||0.797||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 21||||0.7970
71847210|NCT00145470|143208894|SUPERIORITY|||||||0.8339||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 21||||0.8339
71847211|NCT00145470|143208894|SUPERIORITY|||||||0.2101||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 21||||0.2101
71847212|NCT00145470|143208895|SUPERIORITY|||||||0.6914||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 84||||0.6914
71898881|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|2.2||||0.21|TWO_SIDED|95.0|0.64|7.527|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.527|0.640|0.210
71847213|NCT00145470|143208895|SUPERIORITY|||||||0.8805||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 84||||0.8805
71847214|NCT00145470|143208895|SUPERIORITY|||||||0.4878||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 84||||0.4878
71847215|NCT00145470|143208895|SUPERIORITY|||||||0.8051||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 84||||0.8051
71847216|NCT00145470|143208895|SUPERIORITY|||||||0.1925||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 84||||0.1925
71898882|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.031|TWO_SIDED|95.0|1.138|13.29|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||13.290|1.138|0.031
71898883|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|1.64||||0.429|TWO_SIDED|95.0|0.479|5.63|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.630|0.479|0.429
71678746|NCT02091375|142875616|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0784|TWO_SIDED|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|Stratified by age group (2-5 years, 6-12 years, and 13-18 years).||||4.30|0.93|0.0784
71678747|NCT03875482|142875661|SUPERIORITY||Mean Difference|59.0|||<|0.001|TWO_SIDED|95.0|48.4|69.6|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||69.6|48.4|<0.001
71898884|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|9.26||||0.01|TWO_SIDED|95.0|1.712|50.043|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||50.043|1.712|0.010
71898885|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|3.45||||0.15|TWO_SIDED|95.0|0.637|18.627|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||18.627|0.637|0.150
71898886|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|5.47||||0.048|TWO_SIDED|95.0|1.012|29.578|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||29.578|1.012|0.048
71847217|NCT00145470|143208895|SUPERIORITY|||||||0.0514||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 84||||0.0514
71847218|NCT00145470|143208895|SUPERIORITY|||||||0.9898||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 84||||0.9898
71847219|NCT00145470|143208895|SUPERIORITY|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 84||||0.5683
71847220|NCT00145470|143208895|SUPERIORITY|||||||0.8907||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 84||||0.8907
71847221|NCT00145470|143208896|SUPERIORITY|||||||0.0613|||||||Log Rank|||||||0.0613
71847222|NCT00145470|143208897|SUPERIORITY|||||||0.7493||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21||||0.7493
71847223|NCT00145470|143208898|SUPERIORITY|||||||0.4884||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84||||0.4884
71847224|NCT00145470|143208899|SUPERIORITY|||||||0.128||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 21||||0.1280
71847225|NCT00145470|143208899|SUPERIORITY|||||||0.0215||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 21||||0.0215
71847226|NCT00145470|143208900|SUPERIORITY|||||||0.1331||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 84||||0.1331
71847227|NCT00145470|143208900|SUPERIORITY|||||||0.2024||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 84||||0.2024
71847228|NCT06922643|143208947|OTHER||Odds Ratio (OR)|6.73||||0.008|TWO_SIDED|95.0|1.63|27.8|||Regression, Logistic|||||27.8|1.63|0.008
71847229|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Erythema||0.141|-0.216|
71847230|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Swelling||0.141|-0.216|
71847231|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|ALT Increased||0.119|-0.135|
71847232|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.135|0.119|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Hemoglobin Decreased||0.119|-0.135|
71847233|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.205|0.121|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Leukocytosis||0.121|-0.205|
71847234|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.127|0.111|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|PTT Prolonged||0.111|-0.127|
71898887|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|3.98||||0.13|TWO_SIDED|95.0|0.665|23.821|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||23.821|0.665|0.130
71898888|NCT03151148|143321293|SUPERIORITY||Geometric mean ratio (GMR)|13.74||||0.002|TWO_SIDED|95.0|2.542|74.304|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||74.304|2.542|0.002
71815355|NCT03535337|143132582|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.76||0.82|TWO_SIDED|95.0|-1.32|1.66|||Mixed Models Analysis|||||1.66|-1.32|0.82
71815356|NCT03469284|143132588|OTHER|||||||0.0034|||||||ANOVA|||||||0.0034
71815357|NCT03469284|143132589|OTHER|||||||0.0008|||||||ANOVA|||||||0.0008
71815358|NCT03469284|143132591|OTHER|||||||0.9182|||||||Fisher Exact|||||||0.9182
71815359|NCT03469284|143132592|OTHER|||||||0.1046|||||||Fisher Exact|||||||0.1046
71815360|NCT01453348|143132633|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV)|Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.6|1.32||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The Analysis of variance (ANCOVA) model included vaccine group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||1.32|0.6|
71815361|NCT01453348|143132633|NON_INFERIORITY_OR_EQUIVALENCE|(GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg)|Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.59|2.37||The testing was done by assessing the confidence interval of the ratio|ANCOVA|The ANCOVA model included vaccines group and center as factors, age as covariate and was adjusted for baseline.||The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.||2.37|0.59|
71815362|NCT03592277|143132649|SUPERIORITY|||||||0.344|||||||Chi-squared|||||||0.344
71815363|NCT03592277|143132650|SUPERIORITY|||||||0.526|||||||Chi-squared|||||||0.526
71815364|NCT03592277|143132651|SUPERIORITY|||||||0.123|||||||Chi-squared|||||||0.123
71815365|NCT03592277|143132652|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.660
71815366|NCT03592277|143132653|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||||||0.745
71815367|NCT03592277|143132654|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
71815368|NCT01462162|143132664|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.006
71815369|NCT01462162|143132664|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.000
71815370|NCT01462162|143132664|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
71815371|NCT01462162|143132665|SUPERIORITY_OR_OTHER|||||||0.023|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score||||0.023
71815372|NCT01462162|143132665|SUPERIORITY_OR_OTHER|||||||0.007|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score||||0.007
71815373|NCT01462162|143132665|SUPERIORITY_OR_OTHER|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score||||0.000
71815374|NCT01462162|143132666|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 12||||<0.001
71815375|NCT01462162|143132666|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 24||||<0.001
71815376|NCT01462162|143132667|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815377|NCT01462162|143132667|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815378|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in DAS-28 at Week 12||||0.003
71815379|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.006|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in DAS-28 at Week 24||||0.006
71815380|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.791|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in serum hemoglobin Week 12||||0.791
71815381|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.847|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in serum hemoglobin Week 24||||0.847
71815382|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.182|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in swollen joint count Week 12||||0.182
71815383|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.022|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in swollen joint count Week 24||||0.022
71815384|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.163|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in morning stiffness Week 12||||0.163
71815385|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.115|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in morning stiffness Week 24||||0.115
71815386|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.037|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in degree of pain Week 12||||0.037
71847235|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.056|||||TWO_SIDED|95.0|0.022|0.134|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Thrombocytopenia||0.134|0.022|
71847236|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.051|||||TWO_SIDED|95.0|0.018|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fever||0.118|0.018|
71847237|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|-0.036|||||TWO_SIDED|95.0|-0.203|0.089|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Headache||0.089|-0.203|
71847238|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.166|||||TWO_SIDED|95.0|0.016|0.275|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Rash||0.275|0.016|
71898889|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|3.68||||0.001|TWO_SIDED|95.0|1.689|8.028|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.028|1.689|0.001
71922615|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Group Mean Ratio|1.13|||||TWO_SIDED|96.67|1.02|1.25||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.25|1.02|
71847239|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|0.03|0.126|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Arthralgia||0.126|0.030|
71847240|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.023|||||TWO_SIDED|95.0|-0.155|0.118|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Fatigue||0.118|-0.155|
71847241|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.041|||||TWO_SIDED|95.0|-0.105|0.105|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Myalgia||0.105|-0.105|
71922616|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.01|||||TWO_SIDED|96.67|0.91|1.12||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.12|0.91|
71847242|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.019|||||TWO_SIDED|95.0|-0.16|0.114|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Nausea||0.114|-0.160|
71847243|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Photophobia||0.141|-0.216|
71847244|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.024|||||TWO_SIDED|95.0|-0.142|0.088|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Retro-orbital Pain||0.088|-0.142|
71847245|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Decrease in Activity||0.141|-0.216|
71847246|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.216|0.141|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Loss of Appetite||0.141|-0.216|
71922617|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratio|0.89|||||TWO_SIDED|96.67|0.8|0.99||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||0.99|0.80|
71922618|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.19|||||TWO_SIDED|96.67|0.74|1.93||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.93|0.74|
71922619|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.85|||||TWO_SIDED|96.67|0.52|1.38||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.38|0.52|
71922620|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.71|||||TWO_SIDED|96.67|0.44|1.15||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.15|0.44|
71922621|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.14|||||TWO_SIDED|96.67|1.01|1.3||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.30|1.01|
71898890|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.027|TWO_SIDED|95.0|1.109|5.267|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.267|1.109|0.027
71898891|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.153|TWO_SIDED|95.0|0.81|3.847|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.847|0.810|0.153
71898892|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|1.76||||0.16|TWO_SIDED|95.0|0.799|3.884|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.884|0.799|0.160
71898893|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|1.32||||0.489|TWO_SIDED|95.0|0.603|2.868|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.868|0.603|0.489
71898894|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|3.1||||0.044|TWO_SIDED|95.0|1.032|9.295|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.295|1.032|0.044
71898895|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|0.87||||0.805|TWO_SIDED|95.0|0.29|2.614|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.614|0.290|0.805
71898896|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|3.62||||0.022|TWO_SIDED|95.0|1.205|10.859|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||10.859|1.205|0.022
71898897|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|4.83||||0.01|TWO_SIDED|95.0|1.458|15.978|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||15.978|1.458|0.010
71898898|NCT03151148|143321294|SUPERIORITY||Geometric mean ratio (GMR)|2.19||||0.169|TWO_SIDED|95.0|0.716|6.692|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs Non-Lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.692|0.716|0.169
71898899|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.176||||0.035|TWO_SIDED|95.0|0.0351|0.8807|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.8807|0.0351|0.035
71898900|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.214||||0.06|TWO_SIDED|95.0|0.0427|1.0702|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0702|0.0427|0.060
71922622|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.05|||||TWO_SIDED|96.67|0.93|1.19||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.19|0.93|
71678748|NCT03875482|142875662|SUPERIORITY||Mean Difference|68.5|||<|0.001|TWO_SIDED|95.0|57.2|79.7|||Chi-squared|||The variable was analyzed using the Chi-square test. Both null hypotheses corresponding to the co-primary endpoints must be rejected simultaneously under a two-sided significance level of 0.05.||79.7|57.2|<0.001
71678749|NCT03875482|142875663|SUPERIORITY||Mean Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints had been rejected.||46.2|26.2|<0.001
71815387|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.044|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in degree of pain Week 24||||0.044
71815388|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in sleepiness at Week 12||||0.003
71815389|NCT01462162|143132668|SUPERIORITY_OR_OTHER|||||||0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in sleepiness at Week 24||||0.001
71815390|NCT01462162|143132668|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in depression Week 12||||<0.001
71815391|NCT01462162|143132668|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in depression at Week 24||||<0.001
71815392|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.678|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.678
71815393|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.348|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.348
71815394|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.679|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.679
71815395|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.556|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.556
71815396|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.692|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 12)||||0.692
71815397|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.771|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 24)||||0.771
71815398|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.878|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 12)||||0.878
71815399|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.139|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 24)||||0.139
71815400|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.249|||||||Regression, Linear|||change in haemoglobin levels versus change in depression score (Week 12)||||0.249
71815401|NCT01462162|143132669|SUPERIORITY_OR_OTHER|||||||0.61|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.610
71815402|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.257|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 12)||||0.257
71815403|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.487|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 24)||||0.487
71815404|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.644|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)||||0.644
71815405|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.498|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)||||0.498
71898901|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.182||||0.038|TWO_SIDED|95.0|0.0363|0.91|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.9100|0.0363|0.038
71898902|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.329||||0.179|TWO_SIDED|95.0|0.065|1.6691|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.6691|0.0650|0.179
71898903|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.136||||0.015|TWO_SIDED|95.0|0.0271|0.6805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.6805|0.0271|0.015
71898904|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.302||||0.309|TWO_SIDED|95.0|0.0299|3.0493|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.0493|0.0299|0.309
71898905|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.372||||0.401|TWO_SIDED|95.0|0.0369|3.7569|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.7569|0.0369|0.401
71898906|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.591||||0.655|TWO_SIDED|95.0|0.0586|5.9658|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.9658|0.0586|0.655
71922623|NCT00620815|143365491|NON_INFERIORITY_OR_EQUIVALENCE|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.92|||||TWO_SIDED|96.67|0.81|1.04||P-values were not calculated for the equivalence tests due to lack of appropriate statistical software|ANOVA|||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)\*100% CI on one GMA ratio is completely within the equivalence range \[0.5, 2.0\].||1.04|0.81|
71815406|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.65|||||||Regression, Linear|||change in hemoglobin levels versus change in degree of pain (Week 12)||||0.650
71815407|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.75|||||||Regression, Cox|||change in hemoglobin levels versus change in degree of pain (Week 24)||||0.750
71815408|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.936|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 12)||||0.936
71815409|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.075|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 24)||||0.075
71815410|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.098|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 12)||||0.098
71815411|NCT01462162|143132670|SUPERIORITY_OR_OTHER|||||||0.09|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)||||0.090
71815412|NCT01462162|143132671|SUPERIORITY_OR_OTHER|||||||0.077|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 12)||||0.077
71815413|NCT01462162|143132671|SUPERIORITY_OR_OTHER|||||||0.961|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 24)||||0.961
71815414|NCT01462162|143132672|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815415|NCT01462162|143132672|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815416|NCT01462162|143132673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815417|NCT01462162|143132673|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815418|NCT01462162|143132674|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815419|NCT01462162|143132674|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815420|NCT01462162|143132675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815421|NCT01462162|143132675|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815422|NCT01462162|143132676|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815423|NCT01462162|143132676|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815424|NCT01462162|143132677|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815425|NCT01462162|143132677|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815426|NCT01462162|143132678|SUPERIORITY_OR_OTHER|||||||0.172|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.172
71815427|NCT01462162|143132678|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Regression, Logistic|||Baseline for Week 24 versus Week 24||||<0.05
71815428|NCT01462162|143132679|SUPERIORITY_OR_OTHER|||||||0.162|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||0.162
71815429|NCT01462162|143132679|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 24||||<0.001
71815430|NCT01462162|143132680|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815431|NCT01462162|143132680|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
71815432|NCT01462162|143132681|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815433|NCT01462162|143132681|SUPERIORITY_OR_OTHER||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.005
71815434|NCT01462162|143132682|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12||||<0.001
71815435|NCT01462162|143132682|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24||||<0.001
71815436|NCT03485911|143132686|SUPERIORITY||negative binomial regression model|30.0||||0.024|TWO_SIDED|95.0|4.6|48.7|||negative binomial regression model|||||48.7|4.6|0.024
71815437|NCT03485911|143132686|SUPERIORITY||negative binomial regression model|44.2|||<|0.001|TWO_SIDED|95.0|23.0|59.5|||negative binomial regression model|||||59.5|23.0|<0.001
71815438|NCT03485911|143132688|SUPERIORITY||Mean Difference (Final Values)|-2.77||||0.453|TWO_SIDED|95.0|-10.08|4.53|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||4.53|-10.08|0.453
71815439|NCT03485911|143132688|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.188|TWO_SIDED|95.0|-12.23|2.43|||mixed-model repeated measures analysis|||Numerical difference in change from baseline of AE-QoL total score between treatment groups.||2.43|-12.23|0.188
71815440|NCT03485911|143132689|SUPERIORITY||Difference in Least Square Means|-0.062||||0.025|TWO_SIDED|95.0|-0.117|-0.008|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.008|-0.117|0.025
71815441|NCT03485911|143132689|SUPERIORITY||Difference in Least Square Means|-0.078||||0.006|TWO_SIDED|95.0|-0.133|-0.023|||ANCOVA|||Numerical differences from the placebo treatment in the LSM proportion of the 169 days of treatment with angioedema symptoms. In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the second secondary endpoint of number and proportion of days with angioedema symptoms through 24 weeks for statistical significance would not be completed. P-values that are reported are nominal.||-0.023|-0.133|0.006
71815442|NCT03485911|143132690|SUPERIORITY||negative binomial regression model|30.4||||0.026|TWO_SIDED|95.0|4.3|49.3|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||49.3|4.3|0.026
71815443|NCT03485911|143132690|SUPERIORITY||negative binomial regression model|46.5|||<|0.001|TWO_SIDED|95.0|25.6|61.5|||negative binomial regression model|||In the event that the first secondary endpoint did not meet statistical significance in the hierarchical testing scheme, testing of the third secondary endpoint of rate of expert-confirmed HAE attacks during dosing in the effective treatment period for statistical significance would not be completed. P-values reported are nominal.||61.5|25.6|<0.001
71815444|NCT00861601|143132702|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0104
71815445|NCT00861601|143132702|SUPERIORITY_OR_OTHER|||||||0.0057||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0057
71815446|NCT00861601|143132702|SUPERIORITY_OR_OTHER|||||||0.0808||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0808
71815447|NCT00861601|143132703|SUPERIORITY_OR_OTHER|||||||0.0116||95.0||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0116
71815448|NCT00861601|143132703|SUPERIORITY_OR_OTHER|||||||0.0066||95.0||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0066
71815449|NCT00861601|143132703|SUPERIORITY_OR_OTHER|||||||0.0846||95.0||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.||||||0.0846
71815450|NCT00909480|143132722|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: 0.4%.|Mean Difference (Net)|0.3003||||||95.0|0.1427|0.458|||ANCOVA|Full analysis set, Model adjusted for: HbA1c at baseline, previous oral anti-diabetic treatment and country.||||0.4580|0.1427|
71815451|NCT05436912|143132771|OTHER||Geometric Mean Ratio|168.9||||0.3601|TWO_SIDED|90.0|61.3|465.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||465.3|61.3|0.3601
71815452|NCT05436912|143132771|OTHER||Geometric Mean Ratio|92.2||||0.9146|TWO_SIDED|90.0|23.0|368.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||368.9|23.0|0.9146
71815453|NCT05436912|143132771|OTHER||Geometric Mean Ratio|119.6||||0.7478|TWO_SIDED|90.0|43.4|329.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||329.3|43.4|0.7478
71815454|NCT05436912|143132773|OTHER||Geometric Mean Ratio|126.1||||0.4279|TWO_SIDED|90.0|74.8|212.8|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.8|74.8|0.4279
71815455|NCT05436912|143132773|OTHER||Geometric Mean Ratio|92.4||||0.8341|TWO_SIDED|90.0|46.4|183.9|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.9|46.4|0.8341
71847247|NCT02678455|143208957|SUPERIORITY||Risk Difference (RD)|0.083|||||TWO_SIDED|95.0|-0.165|0.218|||||Adjusted proportion difference (TV005 minus Placebo) with inverse variance weighting and Newcombe Score confidence intervals.|Vomiting||0.218|-0.165|
71847248|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|76.0|88.0||||||All study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|76|
71847249|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|99.0|||||TWO_SIDED|95.0|96.0|100.0||||||All study participants seropositive to DENV-2 post TV005 Vaccination. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|96|
71847250|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm|percentage seropositive|96.0|||||TWO_SIDED|95.0|92.0|98.0||||||All study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|92|
71847251|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|87.0|||||TWO_SIDED|95.0|81.0|92.0||||||All study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|81|
71847252|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71678750|NCT03875482|142875664|SUPERIORITY||Mean Difference|37.1|||<|0.001|TWO_SIDED|95.0|27.1|47.2|||Chi-squared|||The ranked secondary efficacy endpoints at Week 16 were to be tested between the risankizumab and placebo treatment groups among the ITT Population in a hierarchical order only if the null hypotheses for both primary endpoints and for the first secondary endpoint had been rejected.||47.2|27.1|<0.001
71847253|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847254|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847255|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847256|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
71847257|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71847258|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847259|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71847260|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
71847261|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71847262|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71847263|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
71847264|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||Young Children study participants seropositive to DENV-1 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
71847265|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Young Children study participants seropositive to DENV-2 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71847266|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Young Children study participants seropositive to DENV-3 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847267|NCT02678455|143208958|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|82.0|98.0||||||Young Children study participants seropositive to DENV-4 post TV005 Vaccination There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|82|
71847268|NCT02678455|143208960|SUPERIORITY||||||<|0.001||||||Comparison between experienced vs dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-1 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||<0.001
71847269|NCT02678455|143208960|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-2 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
71847270|NCT02678455|143208960|SUPERIORITY|||||||0.07||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. Logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-3 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||0.070
71847271|NCT02678455|143208960|SUPERIORITY|||||||1||||||Comparison between experienced vs. dengue naive volunteers post TV005 vaccination. logistic model to adjust for age cohort provides unstable estimates due to quasi separation of data.|Fisher Exact|||DENV-4 percent seropositive post TV005 vaccination: difference between experienced at baseline and naive at baseline||||1.00
71847272|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
71847273|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adult cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
71847274|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71847275|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71847276|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71847277|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
71847278|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
71847279|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adult cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
71847280|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-2 at stud day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
71847281|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adult cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847282|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 180. There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71847283|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71847284|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847285|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71847286|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adult cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71847287|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adult cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
71847288|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|91.0|||||TWO_SIDED|95.0|78.0|97.0||||||Adult cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847289|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71847290|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adult cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71847291|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adult cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71847292|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71847293|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|20.0|||||TWO_SIDED|95.0|10.0|36.0||||||Adult cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||36|10|
71847294|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adult cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
71847295|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|80.0|||||TWO_SIDED|95.0|64.0|90.0||||||Adult cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|64|
71847296|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adult cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
71847297|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adult cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
71847298|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adult cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
71847299|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|63.0|||||TWO_SIDED|95.0|46.0|77.0||||||Adult cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||77|46|
71898907|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|0.43||||0.488|TWO_SIDED|95.0|0.0395|4.6836|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||4.6836|0.0395|0.488
71898908|NCT03151148|143321295|SUPERIORITY||Geometric mean ratio (GMR)|1.485||||0.737|TWO_SIDED|95.0|0.1471|14.9869|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||14.9869|0.1471|0.737
71898909|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.248||||0.011|TWO_SIDED|95.0|0.0844|0.7281|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||0.7281|0.0844|0.011
71847300|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|26.0|||||TWO_SIDED|95.0|14.0|42.0||||||Adolescent cohort: percent seropositive to DENV-1 a study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||42|14|
71815456|NCT05436912|143132773|OTHER||Geometric Mean Ratio|169.1||||0.1159|TWO_SIDED|90.0|97.1|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.1|0.1159
71898910|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.656||||0.44|TWO_SIDED|95.0|0.2245|1.9178|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.9178|0.2245|0.440
71815457|NCT05436912|143132774|OTHER||Geometric Mean Ratio|126.0||||0.4289|TWO_SIDED|90.0|74.8|212.4|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||212.4|74.8|0.4289
71815458|NCT05436912|143132774|OTHER||Geometric Mean Ratio|92.3||||0.8322|TWO_SIDED|90.0|46.5|183.3|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||183.3|46.5|0.8322
71815459|NCT05436912|143132774|OTHER||Geometric Mean Ratio|169.6||||0.1131|TWO_SIDED|90.0|97.6|294.6|||t-test, 2 sided||Geometric mean ratio for natural log transformed parameter (expressed as a percent) and 90% confidence interval for geometric mean ratio of natural log transformed parameter (expressed as a percent), natural log transformed back to the linear scale.|||294.6|97.6|0.1131
71815460|NCT03885011|143132784|SUPERIORITY||Odds Ratio (OR)|1.103||||0.8445|TWO_SIDED|95.0|0.413|2.949|||Regression, Logistic|||This analysis relates to Day 8 up to when pilocarpine HCl 0.2% either in CSF-1-FDC or as pilocarpine alone was administered for one week.||2.949|0.413|0.8445
71815461|NCT03885011|143132784|SUPERIORITY||Odds Ratio (OR)|1.646||||0.266|TWO_SIDED|95.0|0.684|3.958|||Regression, Logistic|||||3.958|0.684|0.2660
71815462|NCT03885011|143132785|SUPERIORITY||Odds Ratio (OR)|3.664||||0.0015|TWO_SIDED|95.0|1.646|8.154|||Regression, Logistic|||||8.154|1.646|0.0015
71815463|NCT03885011|143132785|SUPERIORITY||Odds Ratio (OR)|4.745||||0.0002|TWO_SIDED|95.0|2.088|10.786|||Regression, Logistic|||||10.786|2.088|0.0002
71815464|NCT03885011|143132786|SUPERIORITY|||||||0.1145|||||||Chi-squared|||||||0.1145
71815465|NCT03885011|143132786|SUPERIORITY|||||||0.0616|||||||Chi-squared|||||||0.0616
71815466|NCT03885011|143132787|SUPERIORITY|||||||0.0074|||||||Chi-squared|||||||0.0074
71815467|NCT03885011|143132787|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
71815468|NCT05266963|143132788|SUPERIORITY|Statistical analysis will be performed using a paired samples Wilcoxon test to compare differences between the two groups.||||||0.43|||||||Wilcoxon (Mann-Whitney)|Wilcoxon matched-pairs||||||0.43
71815469|NCT05266963|143132789|SUPERIORITY|Statistical analysis will be performed using a standard two-tailed t test to compare differences between the two groups.||||||0.52|||||||t-test, 2 sided|||||||0.52
71815470|NCT01725386|143132796|SUPERIORITY_OR_OTHER|||||||0.895|||||||Log Rank (Mantel-Cox)|||||||0.895
71815471|NCT00152009|143132800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0006
71815472|NCT00152009|143132800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.0005
71815473|NCT00152009|143132800|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
71815474|NCT00152009|143132801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.025
71815475|NCT00152009|143132801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||0.035
71815476|NCT00152009|143132801|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
71815477|NCT00152009|143132802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
71815478|NCT00152009|143132802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
71815479|NCT00152009|143132802|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||||||<0.0001
71815480|NCT00152009|143132803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71815481|NCT00152009|143132803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Cochran-Mantel-Haenszel|||||||0.0016
71815482|NCT00152009|143132803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
71815483|NCT00152009|143132804|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71847301|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
71847302|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71847303|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71847304|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
71847305|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
71847306|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|46.0|||||TWO_SIDED|95.0|30.0|62.0||||||Adolescent cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||62|30|
71847307|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|34.0|||||TWO_SIDED|95.0|21.0|51.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||51|21|
71847308|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|100.0|||||TWO_SIDED|95.0|90.0|100.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|90|
71898911|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.479||||0.178|TWO_SIDED|95.0|0.164|1.4007|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4007|0.1640|0.178
71898912|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.478||||0.18|TWO_SIDED|95.0|0.1624|1.4091|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.4091|0.1624|0.180
71898913|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.357||||0.06|TWO_SIDED|95.0|0.1222|1.0441|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within TMT at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.0441|0.1222|0.060
71898914|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.498||||0.373|TWO_SIDED|95.0|0.1068|2.3188|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 0~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2.3188|0.1068|0.373
71815484|NCT00152009|143132804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013||95.0|||||Cochran-Mantel-Haenszel|||||||0.0013
71815485|NCT00152009|143132804|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71815486|NCT00152009|143132805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1438||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1438
71815487|NCT00152009|143132805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1426||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.1426
71815488|NCT00152009|143132805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0191||95.0|||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category||||0.0191
71815489|NCT00393523|143132857|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||95.2|92.1|97.1||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.1|92.1|<0.001
71847309|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847310|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847311|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|85.0|||||TWO_SIDED|95.0|71.0|94.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71847312|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|74.0|||||TWO_SIDED|95.0|58.0|86.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||86|58|
71847313|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|52.0|81.0||||||Adolescent cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||81|52|
71847314|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|37.0|||||TWO_SIDED|95.0|23.0|54.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|23|
71847315|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71847316|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|94.0|||||TWO_SIDED|95.0|81.0|98.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||98|81|
71847317|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|85.0|99.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||99|85|
71847318|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|74.0|95.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||95|74|
71847319|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
71847320|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|57.0|||||TWO_SIDED|95.0|41.0|72.0||||||Adolescent cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||72|41|
71847321|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|0.0|||||TWO_SIDED|95.0|0.0|10.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||10|0|
71847322|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|67.0|92.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|67|
71847323|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|77.0|||||TWO_SIDED|95.0|61.0|88.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|61|
71847324|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|71.0|||||TWO_SIDED|95.0|55.0|84.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|55|
71678751|NCT03875482|142875665|SUPERIORITY||LS Mean Difference|-36.14|STANDARD_ERROR_OF_MEAN|4.956|<|0.001|TWO_SIDED|95.0|-45.936|-26.346|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 4~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-26.346|-45.936|<0.001
71678752|NCT03875482|142875665|SUPERIORITY||LS Mean Difference|-59.97|STANDARD_ERROR_OF_MEAN|5.326|<|0.001|TWO_SIDED|95.0|-70.501|-49.439|||Mixed-effect Model Repeat Measurements||Risankizumab - placebo|"Risankizumab vs placebo at Week 16~Mixed-effect Model Repeat Measurements (MMRM): The repeated measures analysis was conducted using a mixed model including the baseline value and observed measurements at all post-baseline visits. The mixed model included the categorical fixed effects of treatment, visit and treatment-by-visit interaction as covariates."||-49.439|-70.501|<0.001
71678753|NCT00979875|142875666|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.08|||<|0.0001|TWO_SIDED|90.0|1.7|2.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||2.55|1.70|<0.0001
71678754|NCT00979875|142875666|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|5.26|||<|0.0001|TWO_SIDED|90.0|3.88|7.12||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||7.12|3.88|<0.0001
71678755|NCT00979875|142875666|SUPERIORITY_OR_OTHER||Geometric Least Squares Means Ratio|4.14|||<|0.0001|TWO_SIDED|90.0|3.05|5.6||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||5.60|3.05|<0.0001
71678756|NCT00979875|142875667|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-38.93|||<|0.0001|TWO_SIDED|90.0|-53.31|-24.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-24.55|-53.31|<0.0001
71678757|NCT00979875|142875667|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-26.43||||0.0032|TWO_SIDED|90.0|-40.81|-12.05||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-12.05|-40.81|0.0032
71678758|NCT00979875|142875667|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-42.14|||<|0.0001|TWO_SIDED|90.0|-56.53|-27.76||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||-27.76|-56.53|<0.0001
71678759|NCT02738879|142875672|NON_INFERIORITY|Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.|Between Group Difference in the LSM|-0.46|||||TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM||-0.34|-0.58|
71678760|NCT02738879|142875672|SUPERIORITY|Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.|Between Group Difference in the LSM|-0.46|||<|0.001|TWO_SIDED|95.0|-0.58|-0.34|||LDA|||A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-0.34|-0.58|< 0.001
71678761|NCT02738879|142875673|SUPERIORITY||Event Rate Ratio|0.73|||=|0.039|TWO_SIDED|95.0|0.54|0.98|||Negative Binomial Model|||Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.98|0.54|= 0.039
71815490|NCT00393523|143132857|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|95.0|||<|0.001||97.6|91.6|97.3||Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024). Since only one group met the criteria, that group was retested at α=.012.|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||97.3|91.6|<0.001
71847325|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|66.0|||||TWO_SIDED|95.0|49.0|79.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||79|49|
71847326|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|60.0|||||TWO_SIDED|95.0|44.0|74.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||74|44|
71678762|NCT02738879|142875674|OTHER|95% CI|Between Group Difference in Percentages|-0.3|||||TWO_SIDED|95.0|-2.3|1.7|||Miettinen & Nurminen|||||1.7|-2.3|
71847327|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|43.0|||||TWO_SIDED|95.0|28.0|59.0||||||Adolescent cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||59|28|
71898915|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.281||||0.106|TWO_SIDED|95.0|0.0604|1.3106|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.3106|0.0604|0.106
71815491|NCT00393523|143132857|SUPERIORITY_OR_OTHER||Seroprotection rate (SPR)|91.6||||0.19||95.2|88.0|94.4||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be \> 90% (P-Value \< .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg's step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.||94.4|88.0|0.19
71815492|NCT00393523|143132858|SUPERIORITY_OR_OTHER||Seroprotection Rate (SPR)|97.3||||||95.0|95.0|98.8|||||"Exact binomial confidence interval~Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL"|The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.||98.8|95.0|
71815493|NCT00116844|143132923|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
71815494|NCT00116844|143132924|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||<0.001
71815495|NCT00116844|143132925|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Prescott's method|||||||<0.001
71815496|NCT00116844|143132926|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.800
71815497|NCT00116844|143132927|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Nonparametric tests-Wilcoxon Rank Sum|||||||0.229
71847328|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||Children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
71847329|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
71815498|NCT00116844|143132928|SUPERIORITY_OR_OTHER|||||||0.0331||95.0|||||Prescott's method|||||||0.0331
71815499|NCT01933880|143132929|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Signed Rank Sum Test|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||0.0387
71815500|NCT01933880|143132930|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 1 for the OROS-MPH group||||<0.0001
71815501|NCT01933880|143132931|SUPERIORITY_OR_OTHER|||||||0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 2 for the OROS-MPH group||||0.0001
71815502|NCT01933880|143132932|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 3 for the OROS-MPH group||||<0.0001
71815503|NCT01933880|143132933|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 7 for the OROS-MPH group||||<0.0001
71815504|NCT01933880|143132934|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group||||<0.0001
71815505|NCT02395133|143132958|SUPERIORITY||Percent Change Difference|-14.83|||=|0.0001|TWO_SIDED|95.0|-22.34|-7.33|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-7.33|-22.34|= 0.0001
71815506|NCT02395133|143132958|SUPERIORITY||Percent Change Difference|-17.83|||<|0.0001|TWO_SIDED|95.0|-25.33|-10.34|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-10.34|-25.33|< 0.0001
71815507|NCT02395133|143132958|SUPERIORITY||Percent Change Difference|-21.61|||<|0.0001|TWO_SIDED|95.0|-28.36|-14.87|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.||-14.87|-28.36|<0.0001
71847330|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|61.0|||||TWO_SIDED|95.0|45.0|75.0||||||Children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||75|45|
71678763|NCT02738879|142875675|SUPERIORITY||Between Group Difference in Percentages|-4.1|||=|0.25|TWO_SIDED|95.0|-11.2|2.9|||Miettinen and Nurminen|||||2.9|-11.2|= 0.250
71815508|NCT02395133|143132959|SUPERIORITY||Percentage difference|24.5|||=|0.004|TWO_SIDED|95.0|9.7|39.29||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||39.29|9.70|= 0.0040
71678764|NCT02738879|142875676|SUPERIORITY||Between Group Difference in the LSM|-8.0|||=|0.016|TWO_SIDED|95.0|-14.6|-1.5|||LDA model|||The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.5|-14.6|= 0.016
71815509|NCT02395133|143132959|SUPERIORITY||Percentage difference|28.0|||=|0.0004|TWO_SIDED|95.0|13.32|42.58||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||42.58|13.32|= 0.0004
71815510|NCT02395133|143132959|SUPERIORITY||Percentage difference|41.2|||<|0.0001|TWO_SIDED|95.0|28.93|53.52||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||53.52|28.93|<0.0001
71815511|NCT02395133|143132960|SUPERIORITY||Percentage difference|21.4|||=|0.013|TWO_SIDED|95.0|4.86|38.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||38.00|4.86|= 0.0130
71815512|NCT02395133|143132960|SUPERIORITY||Percentage difference|33.5|||=|0.0003|TWO_SIDED|95.0|17.38|49.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||49.72|17.38|= 0.0003
71815513|NCT02395133|143132960|SUPERIORITY||Percentage difference|42.1|||<|0.0001|TWO_SIDED|95.0|28.36|55.76||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||55.76|28.36|<0.0001
71815514|NCT02395133|143132961|SUPERIORITY||Percentage difference|18.5|||=|0.0209|TWO_SIDED|95.0|4.14|32.91||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||32.91|4.14|= 0.0209
71815515|NCT02395133|143132961|SUPERIORITY||Percentage difference|29.7|||=|0.0007|TWO_SIDED|95.0|14.89|44.42||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||44.42|14.89|= 0.0007
71678765|NCT02738879|142875677|SUPERIORITY||Event Rate Ratio|0.81|||=|0.041|TWO_SIDED|95.0|0.67|0.99|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||0.99|0.67|= 0.041
71815516|NCT02395133|143132961|SUPERIORITY||Percentage difference|39.7|||<|0.0001|TWO_SIDED|95.0|27.42|51.95||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||51.95|27.42|<0.0001
71815517|NCT02395133|143132962|SUPERIORITY||Percentage difference|-14.4||||0.1048|TWO_SIDED|95.0|-29.21|0.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||0.32|-29.21|0.1048
71815518|NCT02395133|143132962|SUPERIORITY||Percentage difference|-20.6|||=|0.0107|TWO_SIDED|95.0|-35.32|-5.89||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-5.89|-35.32|= 0.0107
71815519|NCT02395133|143132962|SUPERIORITY||Percentage difference|-36.1|||<|0.0001|TWO_SIDED|95.0|-48.4|-23.74||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.||-23.74|-48.40|<0.0001
71815520|NCT03621202|143132997|OTHER||||||||||||||||||The EBBMS sensitivity was 100%.|||
71815521|NCT03621202|143132998|OTHER||||||||||||||||||The EBBMS specificity was 75%.|||
71815522|NCT03445065|143133018|SUPERIORITY||Mean Difference (Net)|-0.1||||0.341|TWO_SIDED|95.0|-0.4|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm, centre, and type of diabetes as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.1|-0.4|0.341
71847331|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
71847332|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
71847333|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||Children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
71847334|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|54.0||||||Children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||54|22|
71847335|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|33.0|||||TWO_SIDED|95.0|20.0|50.0||||||Children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||50|20|
71847336|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847337|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||Children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
71847338|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847339|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
71847340|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
71847341|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|58.0|||||TWO_SIDED|95.0|42.0|73.0||||||Children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||73|42|
71847342|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|36.0|||||TWO_SIDED|95.0|22.0|52.0||||||Children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||52|22|
71847343|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847344|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|92.0|||||TWO_SIDED|95.0|78.0|97.0||||||Children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||97|78|
71847345|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
71847346|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
71847347|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
71847348|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||Children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
71847349|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
71678766|NCT02738879|142875678|SUPERIORITY||Event Rate Ratio|0.83|||=|0.473|TWO_SIDED|95.0|0.51|1.37|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.37|0.51|= 0.473
71847350|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||Children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
71847351|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|56.0|||||TWO_SIDED|95.0|40.0|70.0||||||Children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||70|40|
71847352|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|44.0|||||TWO_SIDED|95.0|30.0|60.0||||||children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||60|30|
71847353|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71847354|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||Children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
71847355|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|19.0|||||TWO_SIDED|95.0|10.0|35.0||||||children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||35|10|
71847356|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-1 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
71847357|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|78.0|||||TWO_SIDED|95.0|62.0|88.0||||||Young children cohort: percent seropositive to DENV-1 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||88|62|
71847358|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|42.0|||||TWO_SIDED|95.0|27.0|58.0||||||young children cohort: percent seropositive to DENV-1 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||58|27|
71847359|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|53.0|||||TWO_SIDED|95.0|37.0|68.0||||||young children cohort: percent seropositive to DENV-1 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||68|37|
71847360|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71847361|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-1 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71847362|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||Young children cohort: percent seropositive to DENV-1 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71847363|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|11.0|||||TWO_SIDED|95.0|4.0|25.0||||||Young children cohort: percent seropositive to DENV-2 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||25|4|
71847364|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|97.0|||||TWO_SIDED|95.0|86.0|100.0||||||Young children cohort: percent seropositive to DENV-2 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||100|86|
71847365|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||young children cohort: percent seropositive to DENV-2 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71847366|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|81.0|||||TWO_SIDED|95.0|65.0|90.0||||||Young children cohort: percent seropositive to DENV-2 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||90|65|
71847367|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|83.0|||||TWO_SIDED|95.0|68.0|92.0||||||young children cohort: percent seropositive to DENV-2 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||92|68|
71847368|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|Slope|72.0|||||TWO_SIDED|95.0|56.0|84.0||||||young children cohort: percent seropositive to DENV-2 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||84|56|
71847369|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|69.0|||||TWO_SIDED|95.0|53.0|82.0||||||Young children cohort: percent seropositive to DENV-2 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||82|53|
71847370|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|8.0|||||TWO_SIDED|95.0|3.0|22.0||||||Young children cohort: percent seropositive to DENV-3 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||22|3|
71847371|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|86.0|||||TWO_SIDED|95.0|71.0|94.0||||||Young children cohort: percent seropositive to DENV-3 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||94|71|
71847372|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|67.0|||||TWO_SIDED|95.0|50.0|80.0||||||young children cohort: percent seropositive to DENV-3 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||80|50|
71847373|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|50.0|||||TWO_SIDED|95.0|34.0|66.0||||||young children cohort: percent seropositive to DENV-3 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||66|34|
71847374|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
71847375|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|31.0|||||TWO_SIDED|95.0|18.0|47.0||||||young children cohort: percent seropositive to DENV-3 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||47|18|
71847376|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|25.0|||||TWO_SIDED|95.0|14.0|41.0||||||young children cohort: percent seropositive to DENV-3 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||41|14|
71898916|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|1.168||||0.843|TWO_SIDED|95.0|0.2507|5.4434|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.4434|0.2507|0.843
71898917|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|1.559||||0.587|TWO_SIDED|95.0|0.3122|7.7818|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||7.7818|0.3122|0.587
71898918|NCT03151148|143321296|SUPERIORITY||Geometric mean ratio (GMR)|0.707||||0.661|TWO_SIDED|95.0|0.1495|3.3426|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Change from baseline is based on the difference in log10 post-baseline and log10 baseline values. Lesional represents the numerator and Non-Lesional the denominator.|"Lesional vs. Non-lesional within Placebo at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.3426|0.1495|0.661
71847377|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|3.0|||||TWO_SIDED|95.0|0.0|14.0||||||young children cohort: percent seropositive to DENV-4 at study day 0 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||14|0|
71815523|NCT03445065|143133019|SUPERIORITY||Mean Difference (Net)|-1.6||||0.03892|TWO_SIDED|95.0|-3.1|-0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The ANCOVA model included arm and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.1|-3.1|0.03892
71815524|NCT03445065|143133023|SUPERIORITY||Mean Difference (Net)|5.4||||0.056|TWO_SIDED|95.0|-0.1|10.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||10.9|-0.1|0.056
71815525|NCT03445065|143133023|SUPERIORITY||Mean Difference (Net)|4.7||||0.01255|TWO_SIDED|95.0|1.0|8.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||8.4|1.0|0.01255
71815526|NCT03445065|143133024|SUPERIORITY||Mean Difference (Net)|-5.5||||0.015|TWO_SIDED|95.0|-9.9|-1.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>250mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-1.1|-9.9|0.015
71815527|NCT03445065|143133024|SUPERIORITY||Mean Difference (Net)|-1.0||||0.50266|TWO_SIDED|95.0|-4.0|2.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||2.0|-4.0|0.50266
71815528|NCT03445065|143133025|SUPERIORITY||Mean Difference (Net)|-5.1||||0.08|TWO_SIDED|95.0|-10.9|0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia \>180mg/dL Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.6|-10.9|0.080
71815529|NCT03445065|143133025|SUPERIORITY||Mean Difference (Net)|-3.3||||0.10637|TWO_SIDED|95.0|-7.3|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-7.3|0.10637
71815530|NCT03445065|143133026|SUPERIORITY||Mean Difference (Net)|-0.2||||0.671|TWO_SIDED|95.0|-1.2|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-1.2|0.671
71847378|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|89.0|||||TWO_SIDED|95.0|75.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 28 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|75|
71815531|NCT03445065|143133026|SUPERIORITY||Mean Difference (Net)|-1.8||||0.12935|TWO_SIDED|95.0|-4.1|0.5||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.5|-4.1|0.12935
71815532|NCT03445065|143133027|SUPERIORITY||Mean Difference (Net)|-0.1||||0.693|TWO_SIDED|95.0|-0.6|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.4|-0.6|0.693
71815533|NCT03445065|143133028|SUPERIORITY||Mean Difference (Net)|-0.9||||0.753|TWO_SIDED|95.0|-6.7|4.9||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.9|-6.7|0.753
71815534|NCT03445065|143133028|SUPERIORITY||Mean Difference (Net)|-0.4||||0.84307|TWO_SIDED|95.0|-4.6|3.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effect, and % time in euglycemic range (Day0-30) as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.8|-4.6|0.84307
71815535|NCT03445065|143133029|SUPERIORITY||Mean Difference (Net)|-0.9||||0.653|TWO_SIDED|95.0|-4.8|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-4.8|0.653
71847379|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|72.0|||||TWO_SIDED|95.0|56.0|96.0||||||young children cohort: percent seropositive to DENV-4 at study day 56 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||96|56|
71847380|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|47.0|||||TWO_SIDED|95.0|32.0|63.0||||||young children cohort: percent seropositive to DENV-4 at study day 180 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||63|32|
71847381|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 360 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71815536|NCT03445065|143133029|SUPERIORITY||Mean Difference (Net)|2.3||||0.07261|TWO_SIDED|95.0|-0.2|4.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>250mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||4.8|-0.2|0.07261
71815537|NCT03445065|143133030|SUPERIORITY||Mean Difference (Net)|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.4|-4.9|0.685
71815538|NCT03445065|143133030|SUPERIORITY||Mean Difference (Net)|3.1||||0.19785|TWO_SIDED|95.0|-1.6|7.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hyperglycemia (\>180mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||7.8|-1.6|0.19785
71898919|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|1197.16|||<|0.001|TWO_SIDED|95.0|525.563|2726.953|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||2726.953|525.563|<0.001
71815539|NCT03445065|143133031|SUPERIORITY||Mean Difference (Net)|-0.4||||0.549|TWO_SIDED|95.0|-1.5|0.8||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.8|-1.5|0.549
71815540|NCT03445065|143133031|SUPERIORITY||Mean Difference (Net)|-3.3||||0.0318|TWO_SIDED|95.0|-6.3|-0.3||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<70mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.3|-6.3|0.03180
71815541|NCT03445065|143133032|SUPERIORITY||Mean Difference (Net)|0.1||||0.859|TWO_SIDED|95.0|-0.6|0.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.7|-0.6|0.859
71815542|NCT03445065|143133032|SUPERIORITY||Mean Difference (Net)|-2.6||||0.01124|TWO_SIDED|95.0|-4.5|-0.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||-0.6|-4.5|0.01124
71815543|NCT03445065|143133033|SUPERIORITY||Mean Difference (Net)|-0.802|STANDARD_ERROR_OF_MEAN|0.391||0.045|TWO_SIDED|95.0|-1.1585|-0.018||The significance level was set to p\<0.05 (two-sided).|Mixed Models Analysis|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled (D150-180) group minus the Enabled (D90-120) group.|||-0.018|-1.1585|0.045
71815544|NCT03445065|143133034|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.54||0.763|TWO_SIDED|95.0|-2.741|3.682||The significance level was set to p\<0.05 (two-sided).|Mixed Model for Repeated Measures|The model included time and centre as fixed classification effects and % time in hypoglycemia (\<54mg/dL) Day0-30 as baseline covariate.|The mean difference was calculated as the Switch to Enabled (D150-180) group minus the Control (D90-120) group.|||3.682|-2.741|0.763
71815545|NCT03445065|143133035|SUPERIORITY||Mean Difference (Net)|1.3||||0.14|TWO_SIDED|95.0|-0.4|3.0||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.0|-0.4|0.140
71815546|NCT03445065|143133035|SUPERIORITY||Mean Difference (Net)|-0.5||||0.6411|TWO_SIDED|95.0|-2.6|1.6||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.6|-2.6|0.64110
71815547|NCT03445065|143133036|SUPERIORITY||Mean Difference (Net)|1.0||||0.339|TWO_SIDED|95.0|-1.1|3.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|Model included arm, centre, and diabetes type as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||3.1|-1.1|0.339
71815548|NCT03445065|143133036|SUPERIORITY||Mean Difference (Net)|-0.7||||0.57677|TWO_SIDED|95.0|-3.0|1.7||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and glucose variability Day0-30 as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||1.7|-3.0|0.57677
71815549|NCT03445065|143133037|SUPERIORITY||Mean Difference (Net)|-0.1||||0.558|TWO_SIDED|95.0|-0.3|0.2||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm, centre, and diabetes type as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.2|-0.3|0.558
71815550|NCT03445065|143133037|SUPERIORITY||Mean Difference (Net)|-0.1||||0.408|TWO_SIDED|95.0|-0.3|0.1||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference was calculated as the Enabled group minus the Control group.|||0.1|-0.3|0.408
71815551|NCT03445065|143133038|SUPERIORITY||Mean Difference (Net)|0.1||||0.616|TWO_SIDED|95.0|-0.2|0.4||The significance level was set to p\<0.05 (two-sided).|ANCOVA|The model included arm and centre as fixed classification effects, and HbA1c (%) at inclusion as baseline covariate.|The mean difference in HbA1c (%) at Day 180 was calculated as the Enabled group minus the Control group.|||0.4|-0.2|0.616
71815552|NCT03315130|143133059|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.7|=|0.0941|TWO_SIDED|80.0|-4.5|-0.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.1|-4.5|=0.0941
71678767|NCT02738879|142875679|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.624|TWO_SIDED|95.0|-6.2|3.7|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.7|-6.2|= 0.624
71678768|NCT02738879|142875680|SUPERIORITY||Between Group Difference in Percentages|18.8|||<|0.001|TWO_SIDED|95.0|11.6|25.7|||Miettinen and Nurminen|||||25.7|11.6|< 0.001
71678769|NCT02738879|142875681|SUPERIORITY||Between Group Difference in the LSM|-6.5|||=|0.02|TWO_SIDED|95.0|-11.9|-1.0|||LDA|||Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.||-1.0|-11.9|= 0.020
71815553|NCT03315130|143133059|SUPERIORITY||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.7|=|0.0538|TWO_SIDED|80.0|-5.1|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-5.1|=0.0538
71815554|NCT03315130|143133060|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.3|=|0.047|TWO_SIDED|80.0|-3.9|-0.5||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.5|-3.9|=0.0470
71815555|NCT03315130|143133060|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.3|=|0.0392|TWO_SIDED|80.0|-4.0|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-4.0|=0.0392
71815556|NCT03315130|143133061|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.4|=|0.017|TWO_SIDED|80.0|-8.4|-2.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-2.1|-8.4|=0.0170
71815557|NCT03315130|143133061|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|2.4|=|0.0624|TWO_SIDED|80.0|-6.9|-0.6||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-0.6|-6.9|=0.0624
71815558|NCT03315130|143133062|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.2|=|0.1866|TWO_SIDED|80.0|-4.9|0.9||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||0.9|-4.9|=0.1866
71847382|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|28.0|||||TWO_SIDED|95.0|16.0|44.0||||||young children cohort: percent seropositive to DENV-4 at study day 720 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||44|16|
71815559|NCT03315130|143133062|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|2.2|=|0.0391|TWO_SIDED|80.0|-7.0|-1.1||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-1.1|-7.0|=0.0391
71815560|NCT03315130|143133066|SUPERIORITY||LS Mean Difference|-82.597|STANDARD_ERROR_OF_MEAN|3.563|<|0.0001|TWO_SIDED|80.0|-87.249|-77.946||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-77.946|-87.249|<0.0001
71815561|NCT03315130|143133066|SUPERIORITY||LS Mean Difference|-95.689|STANDARD_ERROR_OF_MEAN|3.91|<|0.0001|TWO_SIDED|80.0|-100.794|-90.585||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||-90.585|-100.794|<0.0001
71815562|NCT03315130|143133067|SUPERIORITY||LS Mean Difference|60.123|STANDARD_ERROR_OF_MEAN|9.394|<|0.0001|TWO_SIDED|80.0|47.839|72.408||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||72.408|47.839|<0.0001
71847383|NCT02678455|143208961|OTHER|Estimate of the percentage in each sub-group in the TV005 vaccine arm.|percentage seropositive|22.0|||||TWO_SIDED|95.0|12.0|38.0||||||young children cohort: percent seropositive to DENV-4 at study day 1080 There is no comparison between arms. Only the percentage seropositive in the TV005 vaccine arm is being estimated with confidence interval.||38|12|
71678770|NCT02738879|142875682|OTHER|95% CI|Between Group Difference in Percentages|-2.1|||||TWO_SIDED|95.0|-9.1|5.0|||Miettinen & Nurminen|||||5.0|-9.1|
71815563|NCT03315130|143133067|SUPERIORITY||LS Mean Difference|57.076|STANDARD_ERROR_OF_MEAN|9.269|<|0.0001|TWO_SIDED|80.0|44.955|69.197||1-sided p-value is presented for each active treatment arm compared to the Placebo treatment arm.|ANCOVA||LS mean difference and associated confidence interval are presented for each active treatment arm compared to the Placebo treatment arm.|||69.197|44.955|<0.0001
71815564|NCT02707692|143133072|SUPERIORITY||Mean Difference (Final Values)|-988.0||||0.32|TWO_SIDED|95.0|-2996.3|1020.3|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||1020.3|-2996.3|0.32
71847384|NCT04323800|143208962|SUPERIORITY||Risk Difference (RD)|0.01||||0.42|ONE_SIDED|95.0||||One-sided p-value|Restricted Mean Survival Test statistic|||||||0.42
71847385|NCT04323800|143208963|SUPERIORITY||Risk Difference (RD)|-5.0||||0.67|TWO_SIDED|95.0|-31.0|19.0|||Chi-squared|||||19|-31|0.67
71847386|NCT04323800|143208964|SUPERIORITY||Risk Difference (RD)|-47.0||||0.06|TWO_SIDED|95.0|-100.0|2.0|||Chi-squared|||||2|-100|0.06
71847387|NCT02660086|143209050|SUPERIORITY||Mean Difference (Net)|0.2||||0.7|TWO_SIDED|95.0|-0.6|1.0|||Mixed Models Analysis|||||1.0|-0.6|0.70
71847388|NCT02660086|143209051|SUPERIORITY||Mean Difference (Net)|0.6||||0.2|TWO_SIDED|95.0|-0.3|1.4|||Mixed Models Analysis|||||1.4|-0.3|0.20
71847389|NCT02660086|143209052|SUPERIORITY||Mean Difference (Net)|-1.3||||0.24|TWO_SIDED|95.0|-3.6|0.9|||Mixed Models Analysis|||Change in systolic BP at 12 months||0.9|-3.6|0.24
71847390|NCT02660086|143209052|SUPERIORITY||Mean Difference (Net)|1.5||||0.19|TWO_SIDED|95.0|-0.7|3.7|||Mixed Models Analysis|||Change in systolic BP at 24 months||3.7|-0.7|0.19
71847391|NCT02660086|143209052|SUPERIORITY||Mean Difference (Net)|-1.6||||0.07|TWO_SIDED|95.0|-3.2|0.1|||Mixed Models Analysis|||Change in diastolic BP at 12 months||0.1|-3.2|0.07
71847392|NCT02660086|143209052|SUPERIORITY||Mean Difference (Net)|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.6|||Mixed Models Analysis|||Change in diastolic BP at 24 months||1.6|-1.5|0.94
71847393|NCT02660086|143209053|SUPERIORITY||Mean Difference (Net)|-1.3||||0.54|TWO_SIDED|95.0|-5.6|2.9|||Mixed Models Analysis|||Change in total cholesterol at 12 months||2.9|-5.6|0.54
71847394|NCT02660086|143209053|SUPERIORITY||Mean Difference (Net)|1.6||||0.53|TWO_SIDED|95.0|-3.5|6.7|||Mixed Models Analysis|||Change in total cholesterol at 24 months||6.7|-3.5|0.53
71847395|NCT02660086|143209054|SUPERIORITY||Mean Difference (Net)|-1.2||||0.51|TWO_SIDED|95.0|-4.8|2.4|||Mixed Models Analysis|||Change in LDL at 12 months||2.4|-4.8|0.51
71847396|NCT02660086|143209054|SUPERIORITY||Mean Difference (Net)|1.2||||0.6|TWO_SIDED|95.0|-3.4|5.7|||Mixed Models Analysis|||Change in LDL at 24 months||5.7|-3.4|0.60
71847397|NCT02660086|143209055|SUPERIORITY||Mean Difference (Net)|-2.9||||0.48|TWO_SIDED|95.0|-10.8|5.1|||Mixed Models Analysis|||Change in triglycerides at 12 months||5.1|-10.8|0.48
71847398|NCT02660086|143209055|SUPERIORITY||Mean Difference (Net)|4.0||||0.29|TWO_SIDED|95.0|-3.4|11.5|||Mixed Models Analysis|||Change in triglycerides at 24 months||11.5|-3.4|0.29
71847399|NCT02660086|143209056|SUPERIORITY||Mean Difference (Net)|-0.2||||0.8|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Change in HDL at 12 months||1.5|-1.9|0.80
71847400|NCT02660086|143209056|SUPERIORITY||Mean Difference (Net)|-0.3||||0.72|TWO_SIDED|95.0|-1.9|1.3|||Mixed Models Analysis|||Change in HDL at 24 months||1.3|-1.9|0.72
71847401|NCT02660086|143209057|SUPERIORITY||Mean Difference (Net)|0.0||||0.62|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 12 months||0.1|-0.1|0.62
71847402|NCT02660086|143209057|SUPERIORITY||Mean Difference (Net)|0.0||||0.4|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Change in hemoglobin A1C at 24 months||0.1|0.0|0.40
71847403|NCT02660086|143209058|SUPERIORITY||Mean Difference (Net)|7.3|||<|0.001|TWO_SIDED|95.0|5.4|9.3|||Mixed Models Analysis|||Change in green labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||9.3|5.4|<0.001
71847404|NCT02660086|143209058|SUPERIORITY||Mean Difference (Net)|4.8|||<|0.001|TWO_SIDED|95.0|2.9|6.8|||Mixed Models Analysis|||Change in green-labeled purhases during 12 month follow-up (months 13-24) compared to 12 month baseline||6.8|2.9|<0.001
71847405|NCT02660086|143209059|SUPERIORITY||Mean Difference (Net)|-3.9|||<|0.001|TWO_SIDED|95.0|-5.0|-2.7|||Mixed Models Analysis|||Change in red labeled purchases during 12 month intervention (months 1-12) compared to baseline 12 months||-2.7|-5.0|<0.001
71847406|NCT02660086|143209059|SUPERIORITY||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.3|-2.0|||Mixed Models Analysis|||Change in red labeled purchases during 12-month follow up (months 13-24) compared to baseline 12 months||-2.0|-4.3|<0.001
71847407|NCT02660086|143209060|SUPERIORITY||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|4.2|7.0|||Mixed Models Analysis|||Change in healthy purchasing score during 12 month intervention (months 1-12) compared to baseline 12 months||7.0|4.2|<0.001
71847408|NCT02660086|143209060|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.001|TWO_SIDED|95.0|2.6|5.3|||Mixed Models Analysis|||Change in Healthy Purchasing Score during 12 month follow up (months 13-24) compared to baseline 12 months||5.3|2.6|<0.001
71847409|NCT02660086|143209061|SUPERIORITY||Mean Difference (Net)|1.8|||||TWO_SIDED|95.0|-0.6|4.1||||||Change in HEI scores at 12 months.||4.1|-0.6|
71847410|NCT02660086|143209061|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-0.7|3.8||||||Change in HEI scores at 24 months||3.8|-0.7|
71847411|NCT01653509|143209062|SUPERIORITY_OR_OTHER||Least square mean difference|-911.48||||0.3061|TWO_SIDED|95.0|-2712.65|889.69|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||889.69|-2712.65|0.3061
71847412|NCT01653509|143209062|SUPERIORITY_OR_OTHER||LS Mean Difference|-150.99||||0.4035|TWO_SIDED|95.0|-517.97|215.99|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between treatments for MEV.||215.99|-517.97|0.4035
71847413|NCT01653509|143209063|SUPERIORITY_OR_OTHER||LS Mean Difference|2.48||||0.0486|TWO_SIDED|95.0|0.02|4.93|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).||4.93|0.02|0.0486
71847414|NCT01653509|143209063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.38||||0.0799|TWO_SIDED|95.0|-0.05|0.82|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||0.82|-0.05|0.0799
71847415|NCT01653509|143209064|SUPERIORITY_OR_OTHER||LS mean difference|2.14||||0.179|TWO_SIDED|95.0|-1.06|5.35|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.||5.35|-1.06|0.1790
71815565|NCT02707692|143133072|SUPERIORITY||Mean Difference (Final Values)|-405.0||||0.31|TWO_SIDED|95.0|-1199.7|389.7|||Paired t-test, 2 sided|||Primary hypothesis: Participants will have a higher absolute difference in levels of CD4+ T cell-associated HIV RNA transcription seven days after receiving either Pneumococcal or Influenza vaccinations, when compared to seven days after receiving placebo.||389.7|-1199.7|0.31
71815566|NCT00186498|143133076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Test of within subjects contrast: CVLT Long Delay Free Recall Time 1 (baseline) vs Time 2 (30 days): Placebo (F 4.093) p= 0.071; Memantine (F 35.042) p=0.006|Regression, Linear|||||||0.006
71815567|NCT02202434|143133087|NON_INFERIORITY|10.5% non-inferiority margin|Difference in Percentages|3.1||||0.0027|ONE_SIDED|97.5||8.32|||Farrington-Manning|||||8.32||0.0027
71815568|NCT02202434|143133088|NON_INFERIORITY|9.5% Non-Inferiority margin|Difference in Percentages|-10.1|||<|0.0001|ONE_SIDED|97.5||-4.41|||Farrington-Manning|||||-4.41||<0.0001
71815569|NCT02202434|143133088|SUPERIORITY||Difference in Percentages|-10.2||||0.0006|TWO_SIDED|95.0|-16.3|-4.0|||Chi-squared|||"Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population."||-4.0|-16.3|0.0006
71847416|NCT01653509|143209064|SUPERIORITY_OR_OTHER||LS mean difference|0.37||||0.2446|TWO_SIDED|95.0|-0.27|1.0|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.||1.00|-0.27|0.2446
71847417|NCT01303796|143209070|SUPERIORITY||Hazard Ratio (HR)|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Kaplan-Meier|||The phase III part planned to randomize 485 patients, about 243 per arm (actual 241 patients per arm), over an estimated period of 24 months. Final analysis would occur at approximately 424 deaths, which was expected to be observed about 43 months after the accrual of the first patient. A stratified log rank analysis would have 90% power to detect a 27.5% reduction in the risk of death, i.e., a hazard ratio of 0.725, between Arm A and Arm C.||1.226|0.837|<0.0249
71847418|NCT01303796|143209070|SUPERIORITY||Cox Proportional Hazard|1.08|||<|0.0249|TWO_SIDED|95.0|0.86|1.35||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Presence of antecedent MDS or MPD (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: No (i.e., de novo) vs Presence of antecedent MDS or MPD"||1.35|0.86|<0.0249
71847419|NCT01303796|143209070|SUPERIORITY|Effects of treatments compared in AML patients with baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L|Cox Proportional Hazard|1.57|||<|0.0249|TWO_SIDED|95.0|1.12|2.19||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline peripheral WBC count ≥ 10 x 109/L (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline WBC count ≥ 10 x 109/L vs WBC count ≤ 10 x 109/L"||2.19|1.12|<0.0249
71847420|NCT01303796|143209070|SUPERIORITY||Cox Proportional Hazard|1.01|||<|0.0249|TWO_SIDED|95.0|0.77|1.32||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Baseline bone marrow blast percentage ≥ 50% (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Baseline bone marrow blast percentage ≥ 50% vs Blast percentage ≤ 50%"||1.32|0.77|<0.0249
71815570|NCT02202434|143133089|SUPERIORITY||Difference in Percentages|-6.1|||<|0.0001|TWO_SIDED|95.0|-9.6|-2.6|||Chi-squared|||||-2.6|-9.6|<0.0001
71815571|NCT02714868|143133156|OTHER|||||||0.05|||||||t-test, 2 sided|||For goal attainment, we calculated independent t-tests to compare GAS t-scores across groups at outcome. Lowest score is 0, highest score is 100. 100 is highest goal attainment.||||.05
71815572|NCT00981474|143133162|SUPERIORITY||Risk Ratio (RR)|0.96||||0.752|TWO_SIDED|95.0|0.82|1.121|||Chi-squared|||||1.121|.82|.752
71847421|NCT01303796|143209070|SUPERIORITY||Cox Proportional Hazard|1.27|||<|0.0249|TWO_SIDED|95.0|0.94|1.73|||Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (pre-specified): Unfavorable cytogenetics risk by SWOG (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: Unfavorable cytogenetics vs other"||1.73|0.94|<0.0249
71898920|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|779.24|||<|0.001|TWO_SIDED|95.0|342.093|1774.996|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1774.996|342.093|<0.001
71815573|NCT00981474|143133163|SUPERIORITY||Risk Ratio (RR)|0.55||||0.053|TWO_SIDED|95.0|0.32|0.93|||Chi-squared|||||.93|.32|.053
71815574|NCT00981474|143133164|SUPERIORITY||Risk Ratio (RR)|0.454||||0.149|TWO_SIDED|95.0|0.18|1.17|||Chi-squared|||||1.17|.18|.149
71815575|NCT00981474|143133165|SUPERIORITY||Hazard Ratio (HR)|0.581||||0.144|TWO_SIDED|95.0|0.3|1.13|||Chi-squared|||||1.13|.30|.144
71815576|NCT00981474|143133166|SUPERIORITY||Risk Ratio (RR)|0.724||||0.439|TWO_SIDED|95.0|0.37|1.41|||Chi-squared|||||1.41|.37|.439
71815577|NCT00981474|143133167|SUPERIORITY||Risk Ratio (RR)|0.872||||0.311|TWO_SIDED|95.0|0.69|1.11|||Chi-squared|||||1.11|.69|.311
71815578|NCT00981474|143133168|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.005|1.18|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.18|.005|.103
71815579|NCT00981474|143133169|SUPERIORITY||Risk Ratio (RR)|1.102||||0.608|TWO_SIDED|95.0|0.81|1.5|||Chi-squared|||||1.5|.81|.608
71815580|NCT00981474|143133170|SUPERIORITY||Risk Ratio (RR)|0.564||||0.541|TWO_SIDED|95.0|0.16|1.97|||Fisher Exact|Fisher exact test used due to the small number of events.||||1.97|.16|.541
71815581|NCT00981474|143133171|SUPERIORITY||Risk Ratio (RR)|0.247||||0.103|TWO_SIDED|95.0|0.05|1.18|||Fisher Exact|Fisher exact test used due to small number of events.||||1.18|.05|.103
71815582|NCT00981474|143133172|SUPERIORITY||Risk Ratio (RR)|0.409||||0.129|TWO_SIDED|95.0|0.15|1.14|||Chi-squared|||||1.14|.15|.129
71678771|NCT02738879|142875683|SUPERIORITY||Event Rate Ratio|0.76|||=|0.394|TWO_SIDED|95.0|0.4|1.44|||Negative Binomial Model|||The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).||1.44|0.40|= 0.394
71678772|NCT02738879|142875684|SUPERIORITY||Between Group Difference in Percentages|-1.2|||=|0.74|TWO_SIDED|95.0|-8.2|5.8|||Miettinen and Nurminen|||The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.||5.8|-8.2|= 0.740
71815583|NCT00939731|143133173|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.61|||||TWO_SIDED|90.0|84.84|101.09||||||Natural log transformed AUClast of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.09|84.84|
71815584|NCT00939731|143133176|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|92.43|||||TWO_SIDED|90.0|84.86|100.68||||||Natural log transformed AUC (0-∞) of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||100.68|84.86|
71815585|NCT00939731|143133177|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|98.91|||||TWO_SIDED|90.0|90.18|108.48||||||Natural log transformed Cmax of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CI for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||108.48|90.18|
71815586|NCT01213043|143133183|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin was: \[0.80, 1.25\]|Geometric Least Square Means Ratio|0.85|||<|0.0001|TWO_SIDED|90.0|0.83|0.88|||ANOVA|||Dose proportionality was analysed using an ANOVA model for the natural log-transformed AUC0-7days with treatment, period, and sequence as fixed effects and subject within sequence as a random effect. The treatment dose of 60 mg/kg was the reference treatment and 120 mg/kg was the test treatment. PK parameters in individual subjects for each treatment dose were dose normalized to 60mg/kg based on the actual dose administered at Week 8 or Week 18 (i.e., (AUC0-7days/Actual Dose in mg/kg)\*60mg/kg).||0.88|0.83|<0.0001
71678773|NCT02738879|142875685|SUPERIORITY||Between Group Difference in Percentages|-0.7|||=|0.712|TWO_SIDED|95.0|-4.7|3.2|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.||3.2|-4.7|= 0.712
71815587|NCT01175148|143133217|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED||||||Fisher Exact|||The study used a minimax Simon two-stage design to test the null hypothesis Ho: P \> 0.35 versus the alternative H1: \< 0.15, where P is the probability of grade 2 to 4 acute GVHD at day + 100.||||<0.05
71815588|NCT01010477|143133218|SUPERIORITY_OR_OTHER|||||||0.632||||||threshold for statistical significance: p\< 0.05|Fisher Exact|||Fisher Exact test (2-sided)||||0.632
71815589|NCT02948959|143133228|SUPERIORITY|To control the type-I error rate for the analysis of outcome measure, a hierarchical testing procedure was applied at a 2-sided 5% significant level. Testing was then performed sequentially in the order endpoints were reported. Hierarchical testing sequence continued only if the previous endpoint was statistically significant.|Risk Ratio (RR)|0.353|||<|0.0001|TWO_SIDED|95.0|0.222|0.562||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.562|0.222|<0.0001
71678774|NCT02738879|142875686|SUPERIORITY||Between Group Difference in Percentages|5.3|||=|0.03|TWO_SIDED|95.0|0.5|10.1|||Miettinen and Nurminen|||||10.1|0.5|= 0.030
71678775|NCT01730534|142875706|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.172||95.0|0.84|1.03|||Regression, Cox|||||1.03|0.84|0.172
71815590|NCT02948959|143133229|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|Risk Ratio (RR)|0.407|||<|0.0001|TWO_SIDED|95.0|0.274|0.605||Threshold for statistical significance at 5% significant level.|Negative binomial model||Risk ratio, also called relative risk compares the risk (rate) of an event among one group with the risk (rate) among another group.|Risk ratio and p-value was derived using negative binomial model with total number of events onset from randomization up to Week 52 visit or last contact date (whichever comes earlier) as response variable, with treatment group, age, baseline weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level and number of severe exacerbation events within 1 year prior to study as covariates and log-transformed standardized observation duration as an offset variable.||0.605|0.274|<0.0001
71847422|NCT01303796|143209070|SUPERIORITY||Cox Proportional Hazard|1.222|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Region (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: EU vs US"||||<0.0249
71847423|NCT01303796|143209070|SUPERIORITY||Cox Proportional Hazard|1.071|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Age (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: ≥ 75 years old vs ≤ 75 years old"||||<0.0249
71847424|NCT01303796|143209070|SUPERIORITY||Cox Proportional Hazard|0.956|||<|0.0249|TWO_SIDED|||||one-sided|Log Rank||Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.|"Subgroup analyses (post-hoc): Gender (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Male vs Female"||||<0.0249
71847425|NCT01303796|143209070|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): ECOG status (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment (Arm A) Levels: Status 2 vs \< 2"||||<0.0249
71847426|NCT01303796|143209070|SUPERIORITY||||||<|0.0249||||||one-sided|Log Rank|Predictive factor adjusted; when interaction term was not significant at 10% confidence level, the interaction term was removed from the model.||"Subgroup analyses (post-hoc): HCT-CI score (covariate)~Treatment covariate: alternating sapacitabine/decitabine treatment Levels: HCT-CI score 0-2 vs HCT-CI score \>2"||||<0.0249
71847427|NCT01303796|143209071|SUPERIORITY||Cox Proportional Hazard|1.34||||0.1468|TWO_SIDED|95.0|0.645|2.782|||Fisher Exact|||||2.782|0.645|0.1468
71847428|NCT01303796|143209076|SUPERIORITY|||||||0.0416|||||||Wilcoxon (Mann-Whitney)|||||||0.0416
71847429|NCT01303796|143209077|SUPERIORITY|||||||0.1568|||||||Wilcoxon (Mann-Whitney)|||||||0.1568
71847430|NCT01303796|143209078|SUPERIORITY||Cox Proportional Hazard|1.013|||<|0.0249|TWO_SIDED|95.0|0.837|1.226||one-sided|Log Rank|||||1.226|0.837|<0.0249
71847431|NCT01711294|143209084|SUPERIORITY|Sample sizes were calculated using two-sample t-test for the primary endpoint and z-test for the secondary endpoint with power of 80% and two-sided alpha of 0.05. Hochberg step up procedure was used to adjust for multiple comparison. A p-value \< 0.05 was considered statistically significant.||||||0.84||||||Hochberg step up procedure was used to adjust for multiple comparison.|Wilcoxon (Mann-Whitney)|Wilcoxon was used instead of t-test because the data was not normally distributed.||Study hypothesizes that aspiration % in the 19G Flex and 19G arms would be superior by at least 10% to 22G arm, and aspiration success rate of 19G Flex would be at least 16% greater than 22G and 19G arms. Sample size calculation was performed based on the above hypotheses reached by a consensus of all collaborators and adjusted a priori.||||0.84
71847432|NCT02605174|143209100|SUPERIORITY||Odds Ratio (OR)|1.5||||0.003|TWO_SIDED|95.0|1.1|1.9|||Regression, Logistic|||||1.9|1.1|0.003
71847433|NCT02605174|143209100|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
71847434|NCT02605174|143209100|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
71847435|NCT02605174|143209101|SUPERIORITY||Odds Ratio (OR)|1.4||||0.009|TWO_SIDED|95.0|1.1|1.8|||Regression, Logistic|||||1.8|1.1|0.009
71847436|NCT02605174|143209101|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0|||Regression, Logistic|||||2.0|1.2|<0.001
71847437|NCT02605174|143209101|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.4|2.4|||Regression, Logistic|||||2.4|1.4|<0.001
71847438|NCT02605174|143209102|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.2|||Regression, Logistic|||||2.2|1.3|<0.001
71847439|NCT02605174|143209102|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.7|2.9|||Regression, Logistic|||||2.9|1.7|<0.001
71847440|NCT02605174|143209102|SUPERIORITY||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.8|3.1|||Regression, Logistic|||||3.1|1.8|<0.001
71847441|NCT02605174|143209104|SUPERIORITY||Odds Ratio (OR)|0.7||||0.002|TWO_SIDED|95.0|0.5|0.9|||Regression, Logistic|||||0.9|0.5|0.002
71847442|NCT02605174|143209104|SUPERIORITY||Odds Ratio (OR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.7|||Regression, Logistic|||||0.7|0.4|<0.001
71847443|NCT02605174|143209104|SUPERIORITY||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.3|0.4|||Regression, Logistic|||||0.4|0.3|<0.001
71847444|NCT02605174|143209105|SUPERIORITY||Odds Ratio (OR)|1.0||||0.917|TWO_SIDED|95.0|0.7|1.5|||Regression, Logistic|||||1.5|0.7|0.917
71847445|NCT02605174|143209105|SUPERIORITY||Odds Ratio (OR)|0.7||||0.129|TWO_SIDED|95.0|0.5|1.1|||Regression, Logistic|||||1.1|0.5|0.129
71847446|NCT02605174|143209105|SUPERIORITY||Odds Ratio (OR)|0.8||||0.456|TWO_SIDED|95.0|0.6|1.3|||Regression, Logistic|||||1.3|0.6|0.456
71847447|NCT02605174|143209107|SUPERIORITY||Odds Ratio (OR)|0.9||||0.522|TWO_SIDED|95.0|0.7|1.2|||Regression, Logistic|||||1.2|0.7|0.522
71847448|NCT02605174|143209107|SUPERIORITY||Odds Ratio (OR)|1.1||||0.622|TWO_SIDED|95.0|0.8|1.4|||Regression, Logistic|||||1.4|0.8|0.622
71847449|NCT02605174|143209107|SUPERIORITY||Odds Ratio (OR)|1.0||||0.992|TWO_SIDED|95.0|0.8|1.3|||Regression, Logistic|||||1.3|0.8|0.992
71847450|NCT02605174|143209108|SUPERIORITY||Odds Ratio (OR)|1.4||||0.008|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.008
71847451|NCT02605174|143209108|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0|||Regression, Logistic|||||2.0|1.3|<0.001
71847452|NCT02605174|143209108|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
71847453|NCT02605174|143209109|SUPERIORITY||Odds Ratio (OR)|1.4||||0.007|TWO_SIDED|95.0|1.1|1.7|||Regression, Logistic|||||1.7|1.1|0.007
71847454|NCT02605174|143209109|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.3|2.1|||Regression, Logistic|||||2.1|1.3|<0.001
71847455|NCT02605174|143209109|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.4|2.3|||Regression, Logistic|||||2.3|1.4|<0.001
71847456|NCT03737110|143209112|SUPERIORITY||Hazard Ratio (HR)|0.04|||<|0.0001|TWO_SIDED|95.0|0.01|0.18||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at Run-In Baseline.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.18|0.01|<0.0001
71847457|NCT03737110|143209113|SUPERIORITY||Odds Ratio (OR)|12.727||||0.0002|TWO_SIDED|95.0|2.438|66.428||95% confidence interval (CI) and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||66.428|2.438|0.0002
71847458|NCT03737110|143209113|SUPERIORITY||Difference in percentages|61.0|||||TWO_SIDED|95.0|36.7|85.2|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||85.2|36.7|
71847459|NCT03737110|143209114|SUPERIORITY||Least squares (LS) mean difference|51.2|||<|0.0001|TWO_SIDED|95.0|34.5|68.0||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||68.0|34.5|< 0.0001
71678776|NCT01730534|142875707|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.005||95.0|0.73|0.95|||Regression, Cox|||||0.95|0.73|0.005
71847460|NCT03737110|143209115|SUPERIORITY||Odds Ratio (OR)|10.0||||0.0006|TWO_SIDED|95.0|2.136|46.826||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||46.826|2.136|0.0006
71847461|NCT03737110|143209115|SUPERIORITY||Difference in percentages|56.0|||||TWO_SIDED|95.0|30.6|81.3|||||Differences between percentages are reported in percentage points. The 95% confidence intervals for the differences in percentages were based on a normal approximation.|||81.3|30.6|
71847462|NCT03737110|143209116|SUPERIORITY||Odds Ratio (OR)|8.37||||0.0022|TWO_SIDED|95.0|1.317|53.188||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||53.188|1.317|0.0022
71847463|NCT03737110|143209117|SUPERIORITY||Odds Ratio (OR)|10.906|||<|0.0001|TWO_SIDED|95.0|3.051|38.981||95% CI and p-value were analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at run-in baseline.|Cochran-Mantel-Haenszel|||||38.981|3.051|< 0.0001
71847464|NCT03737110|143209118|SUPERIORITY||LS mean difference|51.9|||<|0.0001|TWO_SIDED|95.0|33.8|70.1||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||70.1|33.8|< 0.0001
71847465|NCT03737110|143209119|SUPERIORITY||LS mean difference|40.5|||<|0.0001|TWO_SIDED|95.0|25.3|55.8||Two-sided p-value calculated using analysis of covariance with treatment, randomization strata and run-in baseline NRS weekly average category (NRS ≤ 2 versus NRS \>2) as covariates.|ANCOVA||Least squares mean difference (rilonacept - placebo)|||55.8|25.3|< 0.0001
71847466|NCT03737110|143209120|SUPERIORITY||Odds Ratio (OR)|30.522||||0.0002|TWO_SIDED|95.0|4.262|218.552||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel (CMH) test adjusted by oral corticosteroid use at RI baseline.|Cochran-Mantel-Haenszel|||||218.552|4.262|0.0002
71847467|NCT03737110|143209121|SUPERIORITY||Odds Ratio (OR)|14.432|||<|0.0001|TWO_SIDED|95.0|3.439|60.574||95% CI and p-value are analyzed using a Cochran-Mantel-Haenszel test adjusted by oral corticosteroid use and diagnosis of recurrent idiopathic pericarditis at RI baseline.|Cochran-Mantel-Haenszel|||||60.574|3.439|< 0.0001
71847468|NCT03737110|143209122|SUPERIORITY||Difference|75.7|||<|0.0001|TWO_SIDED|95.0|56.8|94.6|||normal approximation|||||94.6|56.8|< 0.0001
71847469|NCT03737110|143209123|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.32||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.32|0.05|< 0.0001
71847470|NCT03737110|143209124|SUPERIORITY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22||Two-sided p-value is from the log-rank test stratified by oral corticosteroid use at run-in baseline.|Log Rank||Calculated based on a Cox proportional hazards model with treatment as covariate and stratified by oral corticosteroid use at run-in baseline.|||0.22|0.02|< 0.0001
71847471|NCT03737110|143209125|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.7447|TWO_SIDED|95.0|0.12|4.46||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||4.46|0.12|0.7447
71847472|NCT03737110|143209126|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.2066|TWO_SIDED|95.0|0.07|1.87||Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||Calculated based on a Cox proportional-hazards model with treatment as covariate and without stratification by randomization strata.|||1.87|0.07|0.2066
71847473|NCT03737110|143209127|SUPERIORITY||Hazard Ratio (HR)|0.0||||0.0059|TWO_SIDED|95.0|0.0||Not estimable due to low number of participants with an event.|Two-sided p-value is from the log-rank test without stratification by randomization strata.|Log Rank||||||0.00|0.0059
71847474|NCT03737110|143209139|SUPERIORITY||Odds Ratio (OR)|0.015|||<|0.0001|TWO_SIDED|95.0|0.002|0.108||Two-sided p value calculated using a Cochran-Mantel-Haenszel test adjudicated by randomization strata.|Cochran-Mantel-Haenszel|||Participants who used ORT, corticosteroids or bailout rilonacept during the RW Period||0.108|0.002|< 0.0001
71847475|NCT03392194|143209201|OTHER|The purpose of this small pilot randomized control trial (RCT) was to assess feasibility and acceptability of conducting community based sleep hygiene and yoga interventions, to be scaled and tested in a future, larger RCT.|Mean Difference (Net)|-2.02||||0.932|TWO_SIDED|95.0|-46.35|50.39|||t-test, 2 sided|Due to main findings, analysis to explore potential mediators of effect were not pursued, despite original plan to explore explanatory variables.||Null hypothesis: There is no difference in change in sleep duration between the two intervention arms.||50.39|-46.35|0.932
71847476|NCT03068312|143209210|OTHER||Least squares mean difference|-0.66|||||TWO_SIDED|95.0|-1.1|-0.21||||||||-0.21|-1.10|
71847477|NCT02551224|143209211|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75|||<|0.0001|TWO_SIDED|95.0|0.51|0.99|||Wilcoxon (Mann-Whitney)|||||0.99|0.51|<0.0001
71847478|NCT02551224|143209212|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.21|0.61|||Wilcoxon (Mann-Whitney)|||||0.61|0.21|<0.0001
71847479|NCT00273052|143209213|SUPERIORITY_OR_OTHER||Median Difference (Net)|-8.026||||0.0141||95.0|-15.35|-0.67|||ANCOVA||Median difference = Coreg CR - Toprol XL|||-0.67|-15.35|0.0141
71847480|NCT00273052|143209214|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.6068||95.0|-2.4|3.9|||ANCOVA||Mean difference = Coreg CR - Toprol XL|||3.9|-2.4|0.6068
71678777|NCT01730534|142875708|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.001||95.0|0.67|0.87|||Regression, Cox|||||0.87|0.67|<0.001
71678778|NCT01730534|142875709|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.198||95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|0.198
71898921|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|673.56|||<|0.001|TWO_SIDED|95.0|295.697|1534.265|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1534.265|295.697|<0.001
71898922|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|60.12|||<|0.001|TWO_SIDED|95.0|24.92|145.027|||Mixed Models Analysis|||"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|145.027|24.920|<0.001
71815591|NCT02948959|143133230|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.32||||0.0036|TWO_SIDED|95.0|1.76|8.88||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by-visit interaction as covariates.||8.88|1.76|0.0036
71847481|NCT01009645|143209229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.||||<0.05
71847482|NCT01009645|143209229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.||||<0.05
71847483|NCT01009645|143209229|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|ONE_SIDED|95.0||||The a priori threshold for statistical significance was p \<0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.||||<0.05
71847484|NCT01009645|143209230|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||ANOVA|used Scheffe's post-hoc analysis||||||<0.05
71847485|NCT00487240|143209234|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority limit of 0.4% using the upper limit of a two-sided test at a significance level of 0.05 with 90% power assuming a 1.1 Standard Deviations (SD)|Mean Difference (Net)|-0.1||||0.332||95.0|-0.29|0.1|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.||0.10|-0.29|0.332
71847486|NCT00487240|143209235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.718||95.0|-0.22|0.15||P-value for 8 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference=Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.22|0.718
71847487|NCT00487240|143209235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.187||95.0|-0.34|0.07||P-value for 16 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.07|-0.34|0.187
71678779|NCT03369067|142875711|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.010
71847488|NCT00487240|143209235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.704||95.0|-0.25|0.17||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.17|-0.25|0.704
71847489|NCT00487240|143209235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.599||95.0|-0.27|0.15||P-value for 32 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|||0.15|-0.27|0.599
71847490|NCT00487240|143209236|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c ≤7.0%.|Fisher Exact|||||||1.000
71847491|NCT00487240|143209236|SUPERIORITY_OR_OTHER|||||||1||95.0||||P-value for With HbA1c \<7.0%|Fisher Exact|||||||1.000
71847492|NCT00487240|143209236|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value for With HbA1c ≤6.5%|Fisher Exact|||||||0.722
71847493|NCT00487240|143209236|SUPERIORITY_OR_OTHER|||||||0.699||95.0||||P-value for With HbA1c \<6.5%|Fisher Exact|||||||0.699
71678780|NCT03369067|142875711|OTHER|||||||0.089||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.089
71678781|NCT03369067|142875711|OTHER|||||||0.024||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.024
71847494|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-value for Daily Mean 7-Point SMBG.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.259
71847495|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||P-value for Daily Mean Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.468
71847496|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.395||95.0||||P-value for Daily Mean Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.395
71847497|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value for Daily Mean Morning and Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.414
71847498|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Actual Morning Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.275
71847499|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.611||95.0||||P-value for Actual Morning Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.611
71847500|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.763||95.0||||P-value for Actual Midday Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.763
71847501|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||P-value for Actual Midday Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.977
71847502|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.586||95.0||||P-value for Actual Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.586
71847503|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Actual Evening Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.093
71847504|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.516||95.0||||P-value for Actual 0300 Hours|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.516
71847505|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value for Actual Morning SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.576
71847506|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||P-value for Midday SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.876
71847507|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.261||95.0||||P-value for Evening SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.261
71847508|NCT00487240|143209237|SUPERIORITY_OR_OTHER|||||||0.567||95.0||||P-value for Daily Mean SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.567
71847509|NCT00487240|143209238|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 0.8 mmol/L was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.36||||||95.0|-0.03|0.75|||||Least Squares Mean difference = Insulin Lispro Protamine Suspension - Detemir|If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis \[primary outcome measure\] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.||0.75|-0.03|
71847510|NCT00487240|143209238|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for M-Value|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.132
71898923|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|3.79||||0.002|TWO_SIDED|95.0|1.636|8.767|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.767|1.636|0.002
71847511|NCT00487240|143209238|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||P-value for MODD|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country||||||0.179
71847512|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.737||95.0||||P-value for Endpoint Hypoglycemic Episodes|Fisher Exact|||||||0.737
71847513|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||P-value for Overall Hypoglycemic Episodes|Fisher Exact|||||||0.724
71847514|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.157
71847515|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.287||95.0||||P-value for Overall Nocturnal Episodes|Fisher Exact|||||||0.287
71847516|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.664
71847517|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes|Fisher Exact|||||||0.730
71847518|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Endpoint Severe Hypoglycemic Episodes|Fisher Exact|||||||0.053
71847519|NCT00487240|143209239|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||P-value for Overall Severe Hypoglycemic Episodes|Fisher Exact|||||||0.081
71847520|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Endpoint Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.280
71847521|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||P-value for Overall Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.193
71898924|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|757.38|||<|0.001|TWO_SIDED|95.0|331.143|1732.242|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1732.242|331.143|<0.001
71898925|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|199.71|||<|0.001|TWO_SIDED|95.0|87.636|455.127|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||455.127|87.636|<0.001
71898926|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|508.45|||<|0.001|TWO_SIDED|95.0|223.113|1158.715|||Mixed Models Analysis|||"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."|All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|1158.715|223.113|<0.001
71898927|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|107.86|||<|0.001|TWO_SIDED|95.0|45.568|255.313|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||255.313|45.568|<0.001
71898928|NCT03151148|143321297|SUPERIORITY||Geometric mean ratio (GMR)|16.09|||<|0.001|TWO_SIDED|95.0|7.058|36.657|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||36.657|7.058|<0.001
71898929|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|142.89|||<|0.001|TWO_SIDED|95.0|58.484|349.119|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||349.119|58.484|<0.001
71898930|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|35.19|||<|0.001|TWO_SIDED|95.0|14.402|85.972|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||85.972|14.402|<0.001
71847522|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.042||95.0||||P-value for Endpoint Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.042
71847523|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Overall Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.001
71847524|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.579||95.0||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.579
71847525|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.531||95.0||||P-value for Overall Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.531
71847526|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||P-value for Endpoint Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.017
71847527|NCT00487240|143209240|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Overall Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.||||||0.038
71847528|NCT00487240|143209242|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 1.5 kg was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.97||||0.003||95.0|0.34|1.6||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.||1.60|0.34|0.003
71847529|NCT00487240|143209243|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.023
71847530|NCT00487240|143209243|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.004
71847531|NCT00487240|143209243|SUPERIORITY_OR_OTHER|||||||0.282||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.282
71847532|NCT00487240|143209244|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.82
71847533|NCT00487240|143209244|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.19
71847534|NCT00487240|143209244|SUPERIORITY_OR_OTHER|||||||0.416||95.0||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country||||||0.416
71847535|NCT00768755|143209302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.831||||0.3037|TWO_SIDED|95.0|0.508|1.36|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and gender (male or female). Hazard ratio (HR): the stratified Cox model was fitted, using the same stratification variables as above.||1.360|0.508|0.3037
71847536|NCT00768755|143209302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.947||||0.3565|TWO_SIDED|95.0|0.58|1.546|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.546|0.580|0.3565
71847537|NCT00768755|143209303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.046||||0.5785|TWO_SIDED|95.0|0.648|1.69|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||1.690|0.648|0.5785
71847538|NCT00768755|143209303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.449||||0.9392|TWO_SIDED|95.0|0.919|2.285|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.||2.285|0.919|0.9392
71847539|NCT00768755|143209304|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.753||||0.0143|TWO_SIDED|95.0|1.047|2.935|||Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.935|1.047|0.0143
71847540|NCT00768755|143209304|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.512||||0.0665|TWO_SIDED|95.0|0.87|2.626|||Cochran-Mantel-Haenszel|||P-value was calculated using CMH test stratified by ECOG performance status (0 or 1) and gender (male or female).||2.626|0.870|0.0665
71847541|NCT04660799|143209385|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of Ctrough SC versus Ctrough IV.|Ratio Ctrough SC/Ctrough IV|1.52|||||TWO_SIDED|90.0|1.28|1.79||||||Geometric mean ratio of Ctrough SC/Ctrough IV and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.79|1.28|
71847542|NCT04660799|143209386|NON_INFERIORITY|The lower limit of the two-sided 90% confidence interval (CI) should be above 0.80 in order to show non-inferiority of AUCsc versus AUCiv.|Geometric mean ratio of AUCsc/AUCiv|1.25|||||TWO_SIDED|90.0|1.1|1.42||||||Geometric mean ratio of AUCsc/AUCiv and 90% confidence interval were estimated based on an ANCOVA model adjusted for tumor load at baseline.||1.42|1.10|
71847543|NCT04660799|143209391|SUPERIORITY||Difference in CRR|18.27|||||TWO_SIDED|95.0|-8.92|45.45||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||45.45|-8.92|
71847544|NCT04660799|143209392|SUPERIORITY||Difference in ORR Investigator|17.63|||||TWO_SIDED|95.0|-6.86|42.11||||||Investigator; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||42.11|-6.86|
71847545|NCT04660799|143209392|SUPERIORITY||Difference in ORR IRC|14.1|||||TWO_SIDED|95.0|-12.68|40.88||||||IRC; Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||40.88|-12.68|
71847546|NCT04660799|143209393|SUPERIORITY||Difference in CRR|7.05|||||TWO_SIDED|95.0|-22.49|36.59||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||36.59|-22.49|
71847547|NCT04660799|143209394|SUPERIORITY||Difference in CRR|18.59|||||TWO_SIDED|95.0|-9.55|46.73||||||Stratified by IPI score: IPI 0-2 = low to low-intermediate risk versus IPI 3-5 = high-intermediate to high risk||46.73|-9.55|
71898931|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|41.64|||<|0.001|TWO_SIDED|95.0|17.043|101.739|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||101.739|17.043|<0.001
71898932|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|3.61||||0.008|TWO_SIDED|95.0|1.395|9.33|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||9.330|1.395|0.008
71898933|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|1.39||||0.474|TWO_SIDED|95.0|0.561|3.458|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||3.458|0.561|0.474
71898934|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|266.87|||<|0.001|TWO_SIDED|95.0|108.86|654.231|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||654.231|108.860|<0.001
71898935|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|51.07|||<|0.001|TWO_SIDED|95.0|20.907|124.768|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||124.768|20.907|<0.001
71898936|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|74.96|||<|0.001|TWO_SIDED|95.0|30.686|183.125|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||183.125|30.686|<0.001
71898937|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|26.06|||<|0.001|TWO_SIDED|95.0|10.262|66.169|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||66.169|10.262|<0.001
71898938|NCT03151148|143321298|SUPERIORITY||Geometric mean ratio (GMR)|3.41||||0.007|TWO_SIDED|95.0|1.397|8.338|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||8.338|1.397|0.007
71678782|NCT03369067|142875712|OTHER|||||||0.095||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.095
71678783|NCT03369067|142875712|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.104
71678784|NCT03369067|142875712|OTHER|||||||0.042||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.042
71678785|NCT03369067|142875713|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
71678786|NCT03369067|142875713|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678787|NCT03369067|142875713|OTHER|||||||0.065||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.065
71678788|NCT03369067|142875714|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678789|NCT03369067|142875714|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678790|NCT03369067|142875714|OTHER|||||||0.063||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.063
71678791|NCT03369067|142875715|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71847548|NCT00556478|143209431|SUPERIORITY_OR_OTHER||Ratio (over 3 months/Baseline)|3.05|||<|0.0001|TWO_SIDED|95.0|2.29|4.06|||ANCOVA|||||4.06|2.29|<0.0001
71847549|NCT00556478|143209432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||<|0.0001|TWO_SIDED|95.0|3.61|6.34|||ANCOVA|||Analysis of IPE domain ejaculatory control||6.34|3.61|<0.0001
71847550|NCT00556478|143209432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.84|||ANCOVA|||IPE domain sexual satisfaction||5.84|3.30|<0.0001
71847551|NCT00556478|143209432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.0001|TWO_SIDED|95.0|1.86|3.2|||ANCOVA|||IPE domain distress||3.20|1.86|<0.0001
71847552|NCT05270460|143209445|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0||||Adjustment for multiple comparisons were made using Dunnett's test at the overall alpha = 0.05 significance level|ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
71847553|NCT05270460|143209446|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|Fixed effects for treatment group (PCS12852 0.1 mg, PCS12852 0.5 mg, and Placebo) and type (IG or DG) and the baseline value as a continuous covariate||||||<0.05
71847554|NCT05270460|143209447|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71847555|NCT05270460|143209448|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71847556|NCT05270460|143209449|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71847557|NCT05270460|143209450|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71847558|NCT05270460|143209451|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71847559|NCT05270460|143209452|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||||||<0.05
71847560|NCT05270460|143209453|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71847561|NCT05270460|143209454|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71847562|NCT02397707|143209474|OTHER||Geometric Least-Square Mean (GLSM)Ratio%|411.62|||||TWO_SIDED|90.0|214.72|789.08||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.||789.08|214.72|
71847563|NCT02397707|143209474|OTHER||GLSM Ratio (%)|644.15|||||TWO_SIDED|90.0|364.67|1137.82||||||An ANOVA appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1137.82|364.67|
71898939|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|51.1|||<|0.001|TWO_SIDED|95.0|21.692|120.379|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||120.379|21.692|<0.001
71678792|NCT03369067|142875715|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678793|NCT03369067|142875715|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71847564|NCT02397707|143209475|OTHER||GLSM Ratio (%)|399.24|||||TWO_SIDED|90.0|210.89|755.81||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||755.81|210.89|
71847565|NCT02397707|143209475|OTHER||GLSM Ratio (%)|599.63|||||TWO_SIDED|90.0|342.36|1050.22||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.||1050.22|342.36|
71847566|NCT02397707|143209476|OTHER||GLSM Ratio (%)|338.41|||||TWO_SIDED|90.0|168.96|677.79||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||677.79|168.96|
71847567|NCT02397707|143209476|OTHER||GLSM Ratio (%)|713.92|||||TWO_SIDED|90.0|384.07|1327.06||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.||1327.06|384.07|
71898940|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|12.87|||<|0.001|TWO_SIDED|95.0|5.463|30.317|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||30.317|5.463|<0.001
71898941|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|11.46|||<|0.001|TWO_SIDED|95.0|4.863|26.986|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||26.986|4.863|<0.001
71898942|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|2.42||||0.058|TWO_SIDED|95.0|0.971|6.024|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||6.024|0.971|0.058
71678794|NCT03369067|142875716|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71847568|NCT02157948|143209477|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 - denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||One-sided p-value based on the prespecified non-inferiority margin of -1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
71847569|NCT02157948|143209477|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence.|Difference from CP2|-0.07|||<|0.001|TWO_SIDED|95.0|-0.72|0.57||Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 - denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).||0.57|-0.72|< 0.001
71847570|NCT04821271|143209491|OTHER|Treatment comparison||||||0.91|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.91
71847571|NCT04821271|143209492|OTHER|Treatment comparison||||||0.47|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.47
71847572|NCT04821271|143209493|OTHER|Treatment comparison||||||0.14|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.14
71898943|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|0.75||||0.526|TWO_SIDED|95.0|0.315|1.805|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||1.805|0.315|0.526
71678795|NCT03369067|142875716|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678796|NCT03369067|142875716|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678797|NCT03369067|142875717|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678798|NCT03369067|142875717|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678799|NCT03369067|142875717|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678800|NCT03369067|142875718|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678801|NCT03369067|142875718|OTHER|||||||0.062||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.062
71678802|NCT03369067|142875718|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678803|NCT03369067|142875719|OTHER|||||||0.015||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.015
71678804|NCT03369067|142875719|OTHER|||||||0.199||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.199
71678805|NCT03369067|142875719|OTHER|||||||0.025||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.025
71678806|NCT03369067|142875720|OTHER|||||||0.059||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.059
71847573|NCT04821271|143209494|OTHER|Treatment comparison||||||0.12|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.12
71847574|NCT04821271|143209495|OTHER|Treatment comparison||||||0.69|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.69
71847575|NCT04821271|143209496|OTHER|Treatment comparison||||||0.73|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.73
71847576|NCT04821271|143209497|OTHER|Treatment comparison||||||0.28|||||||T-test of estimated marginal means|||The null hypothesis was that there would not be treatment differences in mean MADRS total score. Linear mixed model regression using fixed effects of time, treatment, and a time-by-treatment allowed treatment effect estimates to vary by time. The model also included period specific baseline scores, average per person baseline scores (to avoid cross level bias), and period (first or second). All continuous covariates were mean centered. Alpha level of 0.05, and hypothesis was two-sided.||||0.28
71847577|NCT00822900|143209550|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95||||0.35|TWO_SIDED|95.0|0.85|1.06|||Regression, Generalized linear|Adjusting for injury severity, sex, and age. the binomial distribution with the log link is used to estimate treatment effect as relative risk.|A risk ratio (equivalent to the relative risk) of less than 1.00 indicating fewer favorable outcomes in the progesterone group than in the placebo group.|Test of null hypothesis (equal proportions of subjects with favorable outcome in progesterone and placebo arms) versus alternative hypothesis (unequal proportions of subjects with favorable outcome in progesterone and placebo arms). Standard multiple imputation methods are used to account for missing data. The primary outcome measure is based on the stratified dichotomy approach.||1.06|0.85|0.35
71847578|NCT00822900|143209551|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|0.86|1.63|||||A hazard ratio of more than 1.00 indicating higher hazard of death from the progesterone group than in the placebo group.|The Cox proportional hazards model is used to compare these curves after adjustment for age, sex and injury severity.||1.63|0.86|
71847579|NCT00822900|143209553|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.03|||||TWO_SIDED|95.0|1.96|4.66|||||A risk ratio (equivalent to the relative risk) of more than 1.00 indicating more events in the progesterone group than in the placebo group.|||4.66|1.96|
71847580|NCT02095678|143209562|OTHER|Significance (alpha) set to 0.05||||||0.211|||||||t-test, 2 sided|||||||0.211
71847581|NCT02095678|143209565|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71847582|NCT02095678|143209566|OTHER|Significance (alpha) set to 0.05|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71847583|NCT01934452|143209614|SUPERIORITY||Hodges Lehmann estimator|2.8|||<|0.001|TWO_SIDED|95.0|2.2|3.8|||Wilcoxon (Mann-Whitney)|||||3.8|2.2|<0.001
71847584|NCT01934452|143209615|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71847585|NCT01934452|143209616|SUPERIORITY|||||||1|||||||Fisher Exact|||Extended or partial nephrectomy||||1.000
71847586|NCT01934452|143209616|SUPERIORITY|||||||0.809|||||||Chi-squared|||Nephrectomy with or without adrenalectomy||||0.809
71847587|NCT01934452|143209616|SUPERIORITY|||||||0.019|||||||Chi-squared|||Nephrectomy with or without curettage||||0.019
71847588|NCT01934452|143209616|SUPERIORITY|||||||0.734|||||||Fisher Exact|||Open or laparoscopic nephrectomy||||0.734
71847589|NCT01934452|143209617|SUPERIORITY||Hodges Lehmann estimator|-3.7||||0.23|TWO_SIDED|95.0|-13.2|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-13.2|0.230
71847590|NCT01934452|143209618|SUPERIORITY|||||||0.695|||||||Fisher Exact|||Sarcomatoid contingent||||0.695
71847591|NCT01934452|143209619|SUPERIORITY|||||||0.316|||||||Chi-squared|||M class||||0.316
71847592|NCT01934452|143209620|SUPERIORITY||Hodges Lehmann estimator|-2.0||||0.778|TWO_SIDED|95.0|-22.0|18.0|||Wilcoxon (Mann-Whitney)|||||18.0|-22.0|0.778
71847593|NCT01934452|143209621|SUPERIORITY|||||||0.812|||||||Fisher Exact|||||||0.812
71847594|NCT01934452|143209622|SUPERIORITY||Odds Ratio (OR)|2.47||||0.077|TWO_SIDED|95.0|0.9|6.77|||Chi-squared|||Presence of necrosis||6.77|0.90|0.077
71847595|NCT01934452|143209622|SUPERIORITY||Odds Ratio (OR)|1.25||||0.673|TWO_SIDED|95.0|0.44|3.52|||Chi-squared|||Vascular embolism||3.52|0.44|0.673
71847596|NCT01934452|143209622|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.27|3.97|||Fisher Exact|||Sarcomatoid component||3.97|0.27|1.000
71847597|NCT01934452|143209623|SUPERIORITY||Hodges Lehmann estimator|-0.2||||0.865|TWO_SIDED|95.0|-1.5|1.6|||Wilcoxon (Mann-Whitney)|||||1.6|-1.5|0.865
71847598|NCT01934452|143209624|SUPERIORITY|||||||0.011|||||||Chi-squared|||Lung||||0.011
71847599|NCT01934452|143209624|SUPERIORITY|||||||0.132|||||||Chi-squared|||Bones||||0.132
71847600|NCT01934452|143209624|SUPERIORITY|||||||0.473|||||||Chi-squared|||Liver||||0.473
71847601|NCT01934452|143209624|SUPERIORITY|||||||0.101|||||||Fisher Exact|||Adrenal glands||||0.101
71847602|NCT01934452|143209624|SUPERIORITY|||||||0.445|||||||Fisher Exact|||Pancreas||||0.445
71847603|NCT01934452|143209624|SUPERIORITY|||||||0.04|||||||Chi-squared|||Lymph nodes||||0.040
71847604|NCT01934452|143209625|SUPERIORITY|||||||1|||||||Fisher Exact|||Supradiaphragmatic||||1.000
71847605|NCT01934452|143209625|SUPERIORITY|||||||0.295|||||||Fisher Exact|||Infradiaphragmatic||||0.295
71847606|NCT01934452|143209626|SUPERIORITY|||||||0.042|||||||Fisher Exact|||||||0.042
71847607|NCT01934452|143209627|SUPERIORITY|||||||0.027|||||||Chi-squared|||||||0.027
71847608|NCT01934452|143209628|SUPERIORITY||Hodges Lehmann estimator|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|-1.0|||Wilcoxon (Mann-Whitney)|||||-1.0|-1.0|<0.001
71847609|NCT01934452|143209629|SUPERIORITY|||||||0.009|||||||Fisher Exact|||||||0.009
71847610|NCT00849485|143209693|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|98.0||||||90.0|94.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|94.5|
71847611|NCT00849485|143209694|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|99.9||||||90.0|97.6|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||102|97.6|
71847612|NCT00849485|143209695|NON_INFERIORITY_OR_EQUIVALENCE|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|98.1|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104|98.1|
71847613|NCT00186446|143209696|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|t(19)= -8.93||||||<.001
71847614|NCT01604824|143209725|SUPERIORITY||LS Mean Difference|-53.72|STANDARD_ERROR_OF_MEAN|11.486|=|0.0009|TWO_SIDED|95.0|-79.31|-28.12||Threshold for significance ≤ 0.05|ANCOVA|||||-28.12|-79.31|= 0.0009
71847615|NCT01604824|143209725|SUPERIORITY||LS Mean Difference|-43.28|STANDARD_ERROR_OF_MEAN|10.965|=|0.0056|TWO_SIDED|95.0|-69.21|17.35||Threshold for significance ≤ 0.05|ANCOVA|||||17.35|-69.21|= 0.0056
71847616|NCT01604824|143209726|SUPERIORITY||LS Mean Difference|-49.55|STANDARD_ERROR_OF_MEAN|12.05|=|0.0021|TWO_SIDED|95.0|-76.39|-22.7||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||-22.7|-76.39|= 0.0021
71847617|NCT01604824|143209726|SUPERIORITY||LS Mean Difference|-44.64|STANDARD_ERROR_OF_MEAN|10.876|=|0.0045|TWO_SIDED|95.0|-70.36|18.92||Threshold for significance ≤ 0.05|ANCOVA|||LS means (SE), mean difference, 95% CI, and p-values were derived from ANCOVA with treatment group as factor and baseline as covariate.||18.92|-70.36|= 0.0045
71847618|NCT01604824|143209727|SUPERIORITY||LS Mean Difference|-49.37|STANDARD_ERROR_OF_MEAN|11.487|=|0.0016|TWO_SIDED|95.0|-74.96|-23.77||Threshold for significance ≤ 0.05|ANCOVA|||||-23.77|-74.96|= 0.0016
71847619|NCT01604824|143209727|SUPERIORITY||LS Mean Difference|-40.36|STANDARD_ERROR_OF_MEAN|10.471|=|0.0063|TWO_SIDED|95.0|-65.12|15.6||Threshold for significance ≤ 0.05|ANCOVA|||||15.60|-65.12|= 0.0063
71847620|NCT01604824|143209728|SUPERIORITY||LS Mean Difference|-30.75|STANDARD_ERROR_OF_MEAN|7.224|=|0.0017|TWO_SIDED|95.0|-46.85|-14.66||Threshold for significance ≤ 0.05|ANCOVA|||||-14.66|-46.85|= 0.0017
71898944|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|55.53|||<|0.001|TWO_SIDED|95.0|23.49|131.279|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 0 (post-treatment)~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||131.279|23.490|<0.001
71898945|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|11.78|||<|0.001|TWO_SIDED|95.0|5.0|27.755|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 4~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.755|5.000|<0.001
71898946|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|23.17|||<|0.001|TWO_SIDED|95.0|9.833|54.579|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 7~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||54.579|9.833|<0.001
71898947|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|11.05|||<|0.001|TWO_SIDED|95.0|4.516|27.052|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 8~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||27.052|4.516|<0.001
71898948|NCT03151148|143321299|SUPERIORITY||Geometric mean ratio (GMR)|2.43||||0.042|TWO_SIDED|95.0|1.031|5.724|||Mixed Models Analysis||All reported statistics are back-transformed into the original units of measurement. Baseline is defined as the pre-dose value at treatment initiation/Day 0. TMT represents the numerator and Placebo the denominator.|"TMT vs Placebo on Non-lesional Skin at Day 11~A random effects linear model with the log10 transformed numeric response variable was used, adjusting for treatment group, baseline value, site, lesional swab status, and study day, in addition to all pairwise interactions between day, group and lesional swab status and a 3-way interaction. Random effects of subject and time point nested within subject were also included in the model."||5.724|1.031|0.042
71898949|NCT00494871|143321300|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.0|Hazard Ratio (HR)|1.11||||0.025|TWO_SIDED|95.0|0.87|1.42|||Regression, Cox|||||1.42|0.87|0.025
71898950|NCT00494871|143321301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||||TWO_SIDED|95.0|0.24|1.0||||||||1.00|0.24|
71898951|NCT00494871|143321302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.34|1.22||||||||1.22|0.34|
71898952|NCT00494871|143321303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.41|1.34||||||||1.34|0.41|
71898953|NCT00494871|143321304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.22|0.98||||||||0.98|0.22|
71898954|NCT00494871|143321305|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.06|15.85||||||||15.85|0.06|
71898955|NCT00494871|143321306|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.93|||||TWO_SIDED|95.0|0.3|28.16||||||||28.16|0.30|
71678807|NCT03369067|142875720|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.064
71898956|NCT00494871|143321307|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.97|||||TWO_SIDED|95.0|0.6|14.7||||||||14.70|0.60|
71898957|NCT00494871|143321308|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.16|1.4||||||||1.40|0.16|
71898958|NCT00494871|143321309|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.43|4.31||||||||4.31|0.43|
71898959|NCT00494871|143321310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.5|1.43||||||||1.43|0.50|
71898960|NCT00494871|143321311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.92|1.56||||||||1.56|0.92|
71898961|NCT02433210|143321324|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobilin Optiflux vs Revaclear.||||<0.001
71898962|NCT02433210|143321324|SUPERIORITY||||||<|0.001||||||The p value is not adjusted for multiple comparisons and a p\<0.05 is considered significant.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
71847621|NCT01604824|143209728|SUPERIORITY||LS Mean Difference|-22.23|STANDARD_ERROR_OF_MEAN|6.294|=|0.0096|TWO_SIDED|95.0|-37.11|-7.34||Threshold for significance ≤ 0.05|ANCOVA|||||-7.34|-37.11|= 0.0096
71847622|NCT01604824|143209729|SUPERIORITY||LS Mean Difference|-49.72|STANDARD_ERROR_OF_MEAN|9.867|=|0.0005|TWO_SIDED|95.0|-71.71|-27.74||Threshold for significance ≤ 0.05|ANCOVA|||||-27.74|-71.71|= 0.0005
71847623|NCT01604824|143209729|SUPERIORITY||LS Mean Difference|-49.33|STANDARD_ERROR_OF_MEAN|11.545|=|0.0037|TWO_SIDED|95.0|-76.63|-22.03||Threshold for significance ≤ 0.05|ANCOVA|||||-22.03|-76.63|= 0.0037
71847624|NCT02502461|143209730|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.04|TWO_SIDED|95.0|0.1|1.7||Bonferroni correction|t-test, 2 sided|||||1.7|0.1|0.04
71847625|NCT03775213|143209732|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.91|2.58||||||||2.58|.91|
71847626|NCT03775213|143209733|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.49|1.88||||||Active Monitoring||1.88|.49|
71847627|NCT03775213|143209733|SUPERIORITY||Risk Ratio (RR)|1.06|||||TWO_SIDED|95.0|0.79|1.41||||||Lumpectomy||1.41|.79|
71847628|NCT03775213|143209733|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||Lumpectomy with Radiation||1.30|.62|
71847629|NCT03775213|143209733|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.48|1.47||||||Mastectomy||1.47|.48|
71847630|NCT03775213|143209734|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.59|1.98||||||||1.98|.59|
71847631|NCT03775213|143209735|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.65|1.45||||||||1.45|.65|
71847632|NCT03775213|143209736|SUPERIORITY||Slope|0.09|||||TWO_SIDED|95.0|-0.2|0.38||||||||.38|-.20|
71898963|NCT02433210|143321324|SUPERIORITY||||||=|0.178||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 clearance beta 2 microglobulin Revaclear vs ELISIO..||||=0.178
71847633|NCT04076059|143209753|SUPERIORITY||Cox Proportional Hazard|0.13|||<|0.0001|TWO_SIDED|95.0|0.076|0.222|||Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|||0.222|0.076|<0.0001
71847634|NCT04076059|143209754|SUPERIORITY||Cox Proportional Hazard|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.556|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.556|0.196|<0.0001
71847635|NCT04076059|143209755|SUPERIORITY||Cox Proportional Hazard|0.789||||0.7279|TWO_SIDED|95.0|0.208|2.998|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||2.998|0.208|0.7279
71847636|NCT04076059|143209756|SUPERIORITY||Cox Proportional Hazard|0.172|||<|0.0001|TWO_SIDED|95.0|0.107|0.276|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||0.276|0.107|<0.0001
71847637|NCT04076059|143209757|SUPERIORITY|||||||0.0036|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||0.0036
71847638|NCT04076059|143209758|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||||<0.0001
71847639|NCT04076059|143209759|SUPERIORITY||Cox Proportional Hazard|0.797||||0.5899|TWO_SIDED|95.0|0.35|1.819|||Log Rank|Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.||||1.819|0.350|0.5899
71847640|NCT04076059|143209760|SUPERIORITY||Difference in Percentage|53.5|||<|0.0001|TWO_SIDED|95.0|40.1|66.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||66.9|40.1|<0.0001
71847641|NCT04076059|143209761|SUPERIORITY||Difference in Percentage|-5.2||||0.8312|TWO_SIDED|95.0|-25.4|14.9|||Cochran-Mantel-Haenszel|Stratified by volume of disease and previous docetaxel use during screening period. Parameter estimate: Difference in percentage||||14.9|-25.4|0.8312
71847642|NCT05640167|143209765|OTHER|||||||0.015|||||||t-test, 2 sided|Degrees of freedom 17||||||0.015
71847643|NCT05640167|143209766|OTHER|||||||0.114||||||Positive p = 0.114 Health-directed p = 0.028 Skill and Technique p = 0.013 Constructive attitudes p = 0.003 Self-monitoring \& insight p = 0.001 Health service navigation p = 0.077 Social Integration p = 0.126 Emotional well-being p = 0.093|t-test, 2 sided|||||||0.114
71847644|NCT05640167|143209767|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
71847645|NCT05640167|143209768|OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71847646|NCT05640167|143209769|OTHER|||||||0.309|||||||t-test, 2 sided|||||||0.309
71847647|NCT05640167|143209770|OTHER|||||||0.827|||||||t-test, 2 sided|||||||0.827
71847648|NCT02831816|143209771|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Median Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.221|0.18||||||Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.180|-0.221|
71847649|NCT02831816|143209771|SUPERIORITY||Median Difference (Final Values)|2.45|||||TWO_SIDED|95.0|2.15|2.76||||||Groin 10 minutes Average Treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.76|2.15|
71847650|NCT02831816|143209772|NON_INFERIORITY|Investigational product cannot be more than 0.05 log10 cfu/cm2 less than the active control.|Mean Difference (Final Values)|-0.0435|||||TWO_SIDED|95.0|-0.2085|0.1215||||||Abdomen 10 minutes average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||0.1215|-0.2085|
71847651|NCT02831816|143209772|SUPERIORITY||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|1.7|2.25||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.25|1.70|
71847652|NCT06943638|143209785|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71678808|NCT03369067|142875720|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
71898964|NCT02433210|143321324|SUPERIORITY||||||=|0.016||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs Revaclear.||||=0.016
71898965|NCT02433210|143321324|SUPERIORITY||||||=|0.033||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Optiflux vs ELISIO.||||=0.033
71898966|NCT02433210|143321324|SUPERIORITY||||||=|0.935|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Clearance of myoglobin Revaclear vs ELISIO.||||=0.935
71678809|NCT03369067|142875721|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.034
71898967|NCT02433210|143321324|SUPERIORITY||||||=|0.463|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs Revaclaer.||||=0.463
71898968|NCT02433210|143321324|SUPERIORITY||||||=|0.392|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.392
71847653|NCT03964974|143209808|SUPERIORITY|2-sided hypothesis tests were utilized to compare ISI score over time in the two treatment conditions.|Median Difference (Final Values)|-4.307|STANDARD_ERROR_OF_MEAN|1.612||0.0041|TWO_SIDED|95.0|-7.51|-1.104||This is the calculated p-value. The threshold for statistical significance was 0.05.|Mixed Models Analysis|||Persons in the CBTI-CB condition were hypothesized as realizing greater reduction in insomnia severity as measured by the Insomnia Severity Index (ISI) over time compared to the Sleep Hygiene Education (SHE) condition. 80% power was estimated to detect a medium or larger effect size (d\>0.52) on sleep- and functioning-related outcomes, even with a more conservative alpha set at 0.017 (i.e., 0.05/3 for the 3 outcomes).|Parameter is estimated difference in final means, CBTi-CB - Control. Minus sign denotes greater decrease for CBTi-CB. Effect size for Time X Condition = 0.81|-1.104|-7.510|0.0041
71847654|NCT01214200|143209809|OTHER|For the analysis of differences between pre and post treatment a student's t-test was used and was checked with the Wilcoxon signed rank test. A p\<0.05 was considered statistically significant.||||||0.01|||||||Wilcoxon Signed Ranks Test|||||||0.01
71898969|NCT02433210|143321324|SUPERIORITY||||||=|0.597|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance urea nitrogen Revaclear vs ELISIO.||||=0.597
71898970|NCT02433210|143321324|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs Revaclear.||||=0.162
71898971|NCT02433210|143321324|SUPERIORITY|||||||0.186|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Optiflux vs ELISIO.||||0.186
71898972|NCT02433210|143321324|SUPERIORITY|No Significant difference.||||||0.624|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs Revaclear.||||0.624
71678810|NCT03369067|142875721|OTHER|||||||0.074||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.074
71678811|NCT03369067|142875721|OTHER|||||||0.034||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.034
71898973|NCT02433210|143321324|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea nitrogen clearance Optiflux vs ELISIO.||||0.732
71898974|NCT02433210|143321324|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Urea Nitrogen clearance Revaclear vs Optiflux.||||0.427
71898975|NCT02433210|143321324|SUPERIORITY|||||||0.379|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs Revaclear..||||0.379
71898976|NCT02433210|143321324|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Optiflux vs ELISIO.||||0.318
71898977|NCT02433210|143321324|SUPERIORITY||||||=|0.914|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Creatinine clearance Revaclear vs ELISIO.||||=0.914
71898978|NCT02433210|143321324|SUPERIORITY||||||=|0.623|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs Revaclear.||||=0.623
71678812|NCT03369067|142875722|OTHER|||||||0.023||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.023
71815592|NCT02948959|143133231|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|5.21||||0.0009|TWO_SIDED|95.0|2.14|8.27||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in pre-bronchodilator % predicted FEV1 value up to Week 12 as the response variable, and treatment, baseline weight group, region, ethnicity, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline % predicted FEV1 value and baseline-by visit interaction as covariates.||8.27|2.14|0.0009
71678813|NCT03369067|142875722|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678814|NCT03369067|142875722|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
71678815|NCT03369067|142875723|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678816|NCT03369067|142875723|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71815593|NCT02948959|143133232|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.26||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.26|-0.66|<0.0001
71815594|NCT02948959|143133233|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-0.33||||0.0001|TWO_SIDED|95.0|-0.5|-0.16||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in ACQ-7-IA up to Week 52 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline FeNO level, baseline ICS dose level, visit, treatment by-visit interaction, baseline ACQ-7-IA and baseline-by-visit interaction as covariates.||-0.16|-0.50|0.0001
71815595|NCT02948959|143133234|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-20.59|||<|0.0001|TWO_SIDED|95.0|-24.6|-16.59||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-16.59|-24.60|<0.0001
71815596|NCT02948959|143133235|SUPERIORITY|Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|LS mean difference|-17.84|||<|0.0001|TWO_SIDED|95.0|-21.05|-14.63||Threshold for statistical significance at 5% significant level.|Mixed-effect model with repeated measure|||P-value and LS mean difference were derived from MMRM model with change from baseline in FeNO up to Week 12 as the response variable, and treatment, age, weight group, region, baseline eosinophil level, baseline ICS dose level, visit, treatment by-visit interaction, baseline FeNO value and baseline-by-visit interaction as covariates.||-14.63|-21.05|<0.0001
71815597|NCT03097861|143133304|OTHER|Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|||||=|0.002|||||||ANCOVA|||||||=0.0020
71815598|NCT03097861|143133304|OTHER||||||<|0.0001|||||||ANCOVA|||Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect||||<0.0001
71815599|NCT04091360|143133372|OTHER||GeoMean Ratio|1.221|||<|0.0001|TWO_SIDED|95.0|1.163|1.281|||ANCOVA|||||1.281|1.163|<0.0001
71815600|NCT04091360|143133372|OTHER||GeoMean Ratio|1.203|||<|0.0001|TWO_SIDED|95.0|1.146|1.263|||ANCOVA|||||1.263|1.146|<0.0001
71815601|NCT04091360|143133372|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.085|1.195|||ANCOVA|||||1.195|1.085|<0.0001
71815602|NCT04091360|143133373|OTHER||GeoMean Ratio|1.253|||<|0.0001|TWO_SIDED|95.0|1.151|1.363|||ANCOVA|||||1.363|1.151|<0.0001
71815603|NCT04091360|143133373|OTHER||GeoMean Ratio|1.146||||0.0022|TWO_SIDED|95.0|1.054|1.246|||ANCOVA|||||1.246|1.054|0.0022
71815604|NCT04091360|143133373|OTHER||GeoMean Ratio|1.102||||0.0295|TWO_SIDED|95.0|1.01|1.202|||ANCOVA|||||1.202|1.010|0.0295
71815605|NCT04091360|143133373|OTHER||GeoMean Ratio|1.129||||0.0098|TWO_SIDED|95.0|1.032|1.235|||ANCOVA|||||1.235|1.032|0.0098
71815606|NCT04091360|143133373|OTHER||GeoMean Ratio|1.028||||0.54|TWO_SIDED|95.0|0.939|1.125|||ANCOVA|||||1.125|0.939|0.54
71815607|NCT04091360|143133374|OTHER||GeoMean Ratio|1.228|||<|0.0001|TWO_SIDED|95.0|1.142|1.319|||ANCOVA|||||1.319|1.142|<0.0001
71815608|NCT04091360|143133374|OTHER||GeoMean Ratio|1.155||||0.0002|TWO_SIDED|95.0|1.075|1.24|||ANCOVA|||||1.240|1.075|0.0002
71815609|NCT04091360|143133374|OTHER||GeoMean Ratio|1.1||||0.0129|TWO_SIDED|95.0|1.022|1.184|||ANCOVA|||||1.184|1.022|0.0129
71815610|NCT04091360|143133374|OTHER||GeoMean Ratio|1.112||||0.0079|TWO_SIDED|95.0|1.03|1.201|||ANCOVA|||||1.201|1.030|0.0079
71815611|NCT04091360|143133374|OTHER||GeoMean Ratio|1.033||||0.39|TWO_SIDED|95.0|0.957|1.116|||ANCOVA|||||1.116|0.957|0.39
71678817|NCT03369067|142875723|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678818|NCT03369067|142875724|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678819|NCT03369067|142875724|OTHER|||||||0.081||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.081
71678820|NCT03369067|142875724|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678821|NCT03369067|142875725|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678822|NCT03369067|142875725|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678823|NCT03369067|142875725|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678824|NCT03369067|142875726|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678825|NCT03369067|142875726|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678826|NCT03369067|142875726|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678827|NCT03369067|142875727|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71847655|NCT01719172|143209817|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper-Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.||||<0.0001
71847656|NCT01719172|143209818|SUPERIORITY_OR_OTHER|||||||0.0214||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was \> 50%.|t-test, 1 sided|||The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper-Pearson) 95% confidence interval for the true percentage was calculated.||||0.0214
71678828|NCT03369067|142875727|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678829|NCT03369067|142875727|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678830|NCT03369067|142875728|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678831|NCT03369067|142875728|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678832|NCT03369067|142875728|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678833|NCT03369067|142875729|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678834|NCT03369067|142875729|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678835|NCT03369067|142875729|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678836|NCT03369067|142875730|OTHER|||||||0.124||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.124
71678837|NCT03369067|142875730|OTHER|||||||0.187||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.187
71678838|NCT03369067|142875730|OTHER|||||||0.04||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.040
71898979|NCT02433210|143321324|SUPERIORITY||||||=|0.403|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and equal variance was used. If data failed either non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Optiflux vs ELISIO.||||=0.403
71898980|NCT02433210|143321324|SUPERIORITY||||||=|0.85|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 1 Phosphate clearance Revaclear vs ELISIO.||||=0.850
71898981|NCT02433210|143321324|SUPERIORITY||||||=|0.815|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of creatinine Revaclear vs ELISIO.||||=0.815
71815612|NCT04091360|143133375|OTHER||GeoMean Ratio|1.137|||<|0.0001|TWO_SIDED|95.0|1.073|1.204|||ANCOVA|||||1.204|1.073|<0.0001
71815613|NCT04091360|143133375|OTHER||GeoMean Ratio|1.091||||0.0041|TWO_SIDED|95.0|1.03|1.155|||ANCOVA|||||1.155|1.030|0.0041
71815614|NCT04091360|143133375|OTHER||GeoMean Ratio|1.019||||0.53|TWO_SIDED|95.0|0.96|1.081|||ANCOVA|||||1.081|0.960|0.53
71815615|NCT04091360|143133383|OTHER||GeoMean Ratio|1.21|||<|0.0001|TWO_SIDED|95.0|1.153|1.27|||ANCOVA|||||1.270|1.153|<0.0001
71815616|NCT04091360|143133383|OTHER||GeoMean Ratio|1.193|||<|0.0001|TWO_SIDED|95.0|1.136|1.252|||ANCOVA|||||1.252|1.136|<0.0001
71815617|NCT04091360|143133383|OTHER||GeoMean Ratio|1.124|||<|0.0001|TWO_SIDED|95.0|1.071|1.179|||ANCOVA|||||1.179|1.071|<0.0001
71815618|NCT04091360|143133384|OTHER||GeoMean Ratio|1.139|||<|0.0001|TWO_SIDED|95.0|1.087|1.194|||ANCOVA|||||1.194|1.087|<0.0001
71815619|NCT04091360|143133384|OTHER||GeoMean Ratio|1.142|||<|0.0001|TWO_SIDED|95.0|1.089|1.197|||ANCOVA|||||1.197|1.089|<0.0001
71815620|NCT04091360|143133384|OTHER||GeoMean Ratio|1.08||||0.0018|TWO_SIDED|95.0|1.031|1.132|||ANCOVA|||||1.132|1.031|0.0018
71815621|NCT04091360|143133385|OTHER||GeoMean Ratio|1.08||||0.0066|TWO_SIDED|95.0|1.022|1.14|||ANCOVA|||||1.140|1.022|0.0066
71815622|NCT04091360|143133385|OTHER||GeoMean Ratio|1.074||||0.0115|TWO_SIDED|95.0|1.017|1.134|||ANCOVA|||||1.134|1.017|0.0115
71815623|NCT04091360|143133385|OTHER||GeoMean Ratio|1.037||||0.18|TWO_SIDED|95.0|0.982|1.096|||ANCOVA|||||1.096|0.982|0.18
71815624|NCT04091360|143133386|OTHER||GeoMean Ratio|1.162|||<|0.0001|TWO_SIDED|95.0|1.122|1.203|||ANCOVA|||||1.203|1.122|<0.0001
71815625|NCT04091360|143133386|OTHER||GeoMean Ratio|1.15|||<|0.0001|TWO_SIDED|95.0|1.111|1.19|||ANCOVA|||||1.190|1.111|<0.0001
71815626|NCT04091360|143133386|OTHER||GeoMean Ratio|1.112|||<|0.0001|TWO_SIDED|95.0|1.074|1.152|||ANCOVA|||||1.152|1.074|<0.0001
71815627|NCT04091360|143133387|OTHER||GeoMean Ratio|1.157|||<|0.0001|TWO_SIDED|95.0|1.119|1.196|||ANCOVA|||||1.196|1.119|<0.0001
71815628|NCT04091360|143133387|OTHER||GeoMean Ratio|1.147|||<|0.0001|TWO_SIDED|95.0|1.11|1.186|||ANCOVA|||||1.186|1.110|<0.0001
71815629|NCT04091360|143133387|OTHER||GeoMean Ratio|1.105|||<|0.0001|TWO_SIDED|95.0|1.068|1.142|||ANCOVA|||||1.142|1.068|<0.0001
71815630|NCT04091360|143133388|OTHER||GeoMean Ratio|1.098|||<|0.0001|TWO_SIDED|95.0|1.059|1.137|||ANCOVA|||||1.137|1.059|<0.0001
71815631|NCT04091360|143133388|OTHER||GeoMean Ratio|1.111|||<|0.0001|TWO_SIDED|95.0|1.072|1.15|||ANCOVA|||||1.150|1.072|<0.0001
71815632|NCT04091360|143133388|OTHER||GeoMean Ratio|1.07||||0.0003|TWO_SIDED|5.0|1.033|1.109|||ANCOVA|||||1.109|1.033|0.0003
71815633|NCT04091360|143133389|OTHER||Median Difference (Final Values)|8.5||||0.47|TWO_SIDED||||||Hodges-Lehmann|||||||0.47
71815634|NCT04091360|143133389|OTHER||Mean Difference (Final Values)|18.0||||0.0059|TWO_SIDED||||||Hodges-Lehmann|||||||0.0059
71815635|NCT00098254|143133420|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||Kaplan-Meier|||||||0.0027
71815636|NCT00098254|143133422|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Kaplan-Meier|||||||0.33
71815637|NCT00098254|143133423|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||Kaplan-Meier|||||||0.042
71815638|NCT00098254|143133424|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Kaplan-Meier|||||||0.028
71815639|NCT01515189|143133445|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.7|0.99||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||0.99|0.70|0.0400
71815640|NCT01515189|143133446|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.1548|TWO_SIDED|95.0|0.76|1.04||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model|||1.04|0.76|0.1548
71815641|NCT01515189|143133452|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.49|1.04|||||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases.|||1.04|0.49|
71815642|NCT01395823|143133474|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
71815643|NCT05076149|143133475|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI)|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.5|0.9|||Mixed Models Repeated Measures|||||0.9|-0.5|< 0.0001
71815644|NCT05076149|143133476|SUPERIORITY||LS Mean difference|-2.8|||=|0.0034|TWO_SIDED|95.0|-4.7|-0.9|||Mixed Models Repeated Measures|||||-0.9|-4.7|=0.0034
71815645|NCT05076149|143133477|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.16|||Generalized Estimated Equation Model|||||3.16|1.55|< 0.0001
71815646|NCT05076149|143133478|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
71815647|NCT02087501|143133479|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6|||||The CI is calculated based on Clopper-Pearson method|||11.6|0|
71815648|NCT02087501|143133479|OTHER||Sample proportion|0.0|||||TWO_SIDED|95.0|0.0|11.6||||||||11.6|0|
71815649|NCT02087501|143133480|OTHER||Sample proportion|100.0|||||TWO_SIDED|95.0|88.4|100.0|||||CI is calculated based on Clopper-Pearson method|||100|88.4|
71815650|NCT02087501|143133481|OTHER||Sample proportion|80.0|||||TWO_SIDED|95.0|61.0|92.0||||||||92|61|
71815651|NCT00094328|143133484|OTHER|One sample t-test|Mean Difference (Final Values)|-1.62||||0.278|TWO_SIDED|95.0|-4.72|1.48|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (cm/year) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.48|-4.72|0.278
71847657|NCT01719172|143209819|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0|||||ONE_SIDED|95.0||1.0||||||Time to achieve hemostasis was analyzed using the Kaplan-Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer-Crowley confidence interval for the median was computed based on the sign test.||1.0||
71678839|NCT03369067|142875731|OTHER|||||||0.108||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.108
71815652|NCT00094328|143133485|OTHER|One sample t-test|Median Difference (Final Values)|-0.07||||0.882|TWO_SIDED|95.0|-1.15|1.0|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (SD units) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.||1.00|-1.15|0.882
71847658|NCT00770874|143209820|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.125|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.125
71847659|NCT00770874|143209821|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.48|0.8|||Log Rank|||||0.80|0.48|<0.001
71847660|NCT03960645|143209851|OTHER||GLSM ratio (%)|41.24|||||TWO_SIDED|90.0|36.71|46.32||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio (%).||46.32|36.71|
71847661|NCT03960645|143209851|OTHER||GLSM ratio (%)|44.65|||||TWO_SIDED|90.0|40.04|49.79||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.79|40.04|
71847662|NCT03960645|143209851|OTHER||GLSM ratio (%)|40.57|||||TWO_SIDED|90.0|36.77|44.76||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||44.76|36.77|
71847663|NCT03960645|143209851|OTHER||GLSM ratio (%)|44.4|||||TWO_SIDED|90.0|39.95|49.34||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||49.34|39.95|
71847664|NCT03960645|143209852|OTHER||GLSM ratio (%)|67.38|||||TWO_SIDED|90.0|63.45|71.56||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||71.56|63.45|
71847665|NCT03960645|143209852|OTHER||GLSM ratio (%)|64.26|||||TWO_SIDED|90.0|60.95|67.75||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||67.75|60.95|
71847666|NCT03960645|143209852|OTHER||GLSM ratio (%)|69.19|||||TWO_SIDED|90.0|65.88|72.66||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||72.66|65.88|
71898982|NCT02433210|143321324|SUPERIORITY||||||=|0.367|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of Phosphate Optiflux vs Revaclear.||||=0.367
71898983|NCT02433210|143321324|SUPERIORITY||||||=|0.821|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of phosphate Optiflux vs Elisio.||||=0.821
71898984|NCT02433210|143321324|SUPERIORITY||||||=|0.364|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance phosphate Revaclear vs ELISIO.||||=0.364
71898985|NCT02433210|143321324|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
71678840|NCT03369067|142875731|OTHER|||||||0.053||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.053
71678841|NCT03369067|142875731|OTHER|||||||0.01||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.010
71678842|NCT03369067|142875732|OTHER|||||||0.08||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.080
71815653|NCT01807650|143133559|SUPERIORITY_OR_OTHER||||||=|0.0232||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments."||||=0.0232
71847667|NCT03960645|143209852|OTHER||GLSM ratio (%)|65.09|||||TWO_SIDED|90.0|61.79|68.57||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.57|61.79|
71847668|NCT03960645|143209852|OTHER||GLSM ratio (%)|77.62|||||TWO_SIDED|90.0|65.4|92.14||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||92.14|65.40|
71847669|NCT03960645|143209852|OTHER||GLSM ratio (%)|62.5|||||TWO_SIDED|90.0|50.76|76.96||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||76.96|50.76|
71847670|NCT03960645|143209852|OTHER||GLSM ratio (%)|69.67|||||TWO_SIDED|90.0|58.57|82.88||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.88|58.57|
71847671|NCT03960645|143209852|OTHER||GLSM ratio (%)|56.52|||||TWO_SIDED|90.0|46.32|68.96||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.96|46.32|
71847672|NCT03960645|143209854|OTHER||GLSM ratio (%)|51.91|||||TWO_SIDED|90.0|46.48|57.97||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||57.97|46.48|
71847673|NCT03960645|143209854|OTHER||GLSM ratio (%)|57.67|||||TWO_SIDED|90.0|52.48|63.36||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||63.36|52.48|
71815654|NCT01807650|143133563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_DEVIATION|17.8|=|0.0005|TWO_SIDED|95.0|2.7|9.4||Day 7|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|2.7|=0.0005
71815655|NCT01807650|143133563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|16.9|=|0.0002|TWO_SIDED|95.0|3.0|9.4||Day 10|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.4|3.0|=0.0002
71847674|NCT03960645|143209854|OTHER||GLSM ratio (%)|48.18|||||TWO_SIDED|90.0|43.03|53.94||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||53.94|43.03|
71847675|NCT03960645|143209854|OTHER||GLSM ratio (%)|54.42|||||TWO_SIDED|90.0|48.39|61.21||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||61.21|48.39|
71847676|NCT03960645|143209854|OTHER||GLSM ratio (%)|75.61|||||TWO_SIDED|90.0|66.7|85.7||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.70|66.70|
71847677|NCT03960645|143209854|OTHER||GLSM ratio (%)|77.81|||||TWO_SIDED|90.0|68.76|88.05||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||88.05|68.76|
71847678|NCT03960645|143209854|OTHER||GLSM ratio (%)|77.45|||||TWO_SIDED|90.0|70.33|85.29||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.29|70.33|
71847679|NCT03960645|143209854|OTHER||GLSM ratio (%)|77.08|||||TWO_SIDED|90.0|69.78|85.15||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||85.15|69.78|
71847680|NCT03960645|143209854|OTHER||GLSM ratio (%)|69.9|||||TWO_SIDED|90.0|56.16|87.0||||||TAF: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||87.00|56.16|
71847681|NCT03960645|143209854|OTHER||GLSM ratio (%)|66.55|||||TWO_SIDED|90.0|53.79|82.34||||||TAF: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||82.34|53.79|
71898986|NCT02433210|143321324|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of beta 2 microglobulin Optiflux vs ELISIO.||||<0.001
71898987|NCT02433210|143321324|SUPERIORITY||||||=|0.254|||||||t-test, 2 sided|||Session 2 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.254
71898988|NCT02433210|143321324|SUPERIORITY||||||=|0.079|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs Revaclear.||||=0.079
71898989|NCT02433210|143321324|SUPERIORITY||||||=|0.086|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance of myoglobin Optiflux vs ELISIO.||||=0.086
71898990|NCT02433210|143321324|SUPERIORITY||||||=|0.888|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 2 Clearance myoglobin Revaclear vs ELISIO.||||=0.888
71815656|NCT01807650|143133563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|19.3|=|0.0028|TWO_SIDED|95.0|2.0|9.3||Day 14|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.0|=0.0028
71847682|NCT03960645|143209854|OTHER||GLSM ratio (%)|57.14|||||TWO_SIDED|90.0|46.04|70.91||||||TAF: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.91|46.04|
71847683|NCT03960645|143209854|OTHER||GLSM ratio (%)|55.27|||||TWO_SIDED|90.0|44.65|68.42||||||TAF: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||68.42|44.65|
71847684|NCT03960645|143209855|OTHER||GLSM ratio (%)|26.17|||||TWO_SIDED|90.0|21.45|31.93||||||BIC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||31.93|21.45|
71847685|NCT03960645|143209855|OTHER||GLSM ratio (%)|26.99|||||TWO_SIDED|90.0|22.23|32.78||||||BIC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.78|22.23|
71815657|NCT01807650|143133563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|STANDARD_DEVIATION|18.0|=|0.0009|TWO_SIDED|95.0|2.5|9.3||Day 18|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||9.3|2.5|=0.0009
71847686|NCT03960645|143209855|OTHER||GLSM ratio (%)|29.03|||||TWO_SIDED|90.0|25.74|32.74||||||BIC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||32.74|25.74|
71847687|NCT03960645|143209855|OTHER||GLSM ratio (%)|29.97|||||TWO_SIDED|90.0|26.47|33.93||||||BIC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||33.93|26.47|
71847688|NCT03960645|143209855|OTHER||GLSM ratio (%)|64.22|||||TWO_SIDED|90.0|54.63|75.49||||||FTC: Second Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||75.49|54.63|
71847689|NCT03960645|143209855|OTHER||GLSM ratio (%)|42.89|||||TWO_SIDED|90.0|36.55|50.34||||||FTC: Second Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||50.34|36.55|
71847690|NCT03960645|143209855|OTHER||GLSM ratio (%)|64.71|||||TWO_SIDED|90.0|59.3|70.61||||||FTC: Third Trimester (Test) vs. Week 12 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||70.61|59.30|
71847691|NCT03960645|143209855|OTHER||GLSM ratio (%)|46.92|||||TWO_SIDED|90.0|39.57|55.64||||||FTC: Third Trimester (Test) vs. Week 6 Post-partum (Reference). A 90% CI was constructed for the GLSM ratio (%).||55.64|39.57|
71847692|NCT02746107|143209881|NON_INFERIORITY_OR_EQUIVALENCE|details provided in the protocol. Noninferiority margin=+/-5%|Risk Difference (RD)|0.5||||0.83|TWO_SIDED|95.0|-4.0|5.4|||Chi-squared|||||5.4|-4|0.83
71847693|NCT02746107|143209882|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.4||||0.187|TWO_SIDED|95.0|-1.3|8.1|||Chi-squared||(risk on 5y) - (risk on 1y)|details provided in protocol;||8.1|-1.3|0.187
71847694|NCT02746107|143209883|SUPERIORITY_OR_OTHER||Risk Difference (RD)|15.4|||<|0.001|TWO_SIDED|95.0|10.8|20.0|||Chi-squared||patient - (physicians themselves)|||20|10.8|<0.001
71815658|NCT01807650|143133563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|15.8|=|0.0003|TWO_SIDED|95.0|2.6|8.6||Day 21|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||8.6|2.6|=0.0003
71815659|NCT01807650|143133563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|15.1|=|0.0145|TWO_SIDED|95.0|0.7|6.4||Day 28|t-test, 2 sided||Mean difference in degree of epithelialization \[%\] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)|||6.4|0.7|=0.0145
71815660|NCT00045435|143133574|OTHER||Percent|47.0|||||ONE_SIDED|95.0||69.0|||||The criterion for stopping was not met.|The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was \<35%.||69||
71815661|NCT00045435|143133575|OTHER||percent|6.0|||||ONE_SIDED|80.0|1.0||||||The stopping criterion was not met.|The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%|||1|
71815662|NCT02969525|143133595|OTHER||Correlation statistic|4.6|||=|0.031|||||||Cochran-Mantel-Haenszel|||"Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.~The 160 loading dose arm was not considered in the dose-response because this is a mixed dose and the test is examining linear dose response."||||=0.031
71815663|NCT02969525|143133595|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.2|||=|0.032|TWO_SIDED|95.0|1.13|15.23||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||15.23|1.13|=0.032
71815664|NCT02969525|143133595|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|8.1|||=|0.001|TWO_SIDED|95.0|2.28|28.74||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||28.74|2.28|=0.001
71815665|NCT02969525|143133595|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|9.7|||<|0.001|TWO_SIDED|95.0|2.73|34.26||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||34.26|2.73|<0.001
71847695|NCT02746107|143209883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.28|||<|0.001|TWO_SIDED|95.0|2.25|4.78|||Regression, Logistic|adjustment for age, gender, CHA2D2s-VASC score, nr of diagrams, nr of years, presence of someone close with stroke, graduation year, speciality||||4.78|2.25|<0.001
71815666|NCT02969525|143133595|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|3.7|||=|0.051|TWO_SIDED|95.0|1.0|13.68||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Factor Necrosis (TNF) inhibitor exposure.||13.68|1.00|=0.051
71815667|NCT02969525|143133596|OTHER||Odds Ratio (OR)|4.6|||=|0.002|TWO_SIDED|95.0|1.73|12.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||12.39|1.73|=0.002
71815668|NCT02969525|143133596|OTHER||Odds Ratio (OR)|11.0|||<|0.001|TWO_SIDED|95.0|3.91|30.95||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||30.95|3.91|<0.001
71847696|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.3||||0.034|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|CHA2D2S-VASC risk score 1 was reference|positive value means higher proportion of prescription, CHA2D2S-VASC risk score 1 was reference|CHA2D2S-VASC risk score 1 was the reference||17|1.2|0.034
71847697|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.033|TWO_SIDED|95.0|1.2|17.0|||Chi-squared|||||17|1.2|0.033
71847698|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Risk Difference (RD)|12.4||||0.003|TWO_SIDED|95.0|4.7|20.1|||Chi-squared|||||20.1|4.7|0.003
71898991|NCT02433210|143321324|SUPERIORITY||||||=|0.663||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs Revaclear.||||=0.663
71898992|NCT02433210|143321324|SUPERIORITY||||||=|0.391|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Optiflux vs ELISIO.||||=0.391
71898993|NCT02433210|143321324|SUPERIORITY||||||=|0.214|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of urea nitrogen Revaclear vs ELISIO.||||=0.214
71898994|NCT02433210|143321324|SUPERIORITY||||||=|0.918|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs Revaclear.||||=0.918
71898995|NCT02433210|143321324|SUPERIORITY||||||=|0.394|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Optiflux vs ELISIO.||||=0.394
71898996|NCT02433210|143321324|SUPERIORITY||||||=|0.211|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of creatinine Revaclear vs ELISIO.||||=0.211
71815669|NCT02969525|143133596|OTHER||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.31|16.84||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||16.84|2.31|<0.001
71898997|NCT02433210|143321324|SUPERIORITY||||||=|0.222|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of phosphate Optiflux vs ELISIO.||||=0.222
71898998|NCT02433210|143321324|SUPERIORITY||||||=|0.162|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of phosphate Revaclear vs ELISIO.||||=0.162
71847699|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Risk Difference (RD)|11.1||||0.009|TWO_SIDED|95.0|3.2|18.8|||Chi-squared|||||18.8|3.2|0.009
71847700|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.024|TWO_SIDED|95.0|1.08|3.07|||Regression, Logistic|CHA2D2S-VASC risk score 1 was the reference, adjusted for nr diagrams, nr years, age, gender, smb close with stroke, speciality, professional degree||CHA2D2S-VASC risk score 1 was the reference||3.07|1.08|0.024
71847701|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77||||0.03|TWO_SIDED|95.0|1.06|2.98|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator: CHADS-VASC 1|||2.98|1.06|0.03
71847702|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.002|TWO_SIDED|95.0|1.37|4.09|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator = CHADS-VASC 1|||4.09|1.37|0.002
71847703|NCT02746107|143209884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.004|TWO_SIDED|95.0|1.14|2.56|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator=CHADS-VASC 1|||2.56|1.14|0.004
71847704|NCT00403494|143209899|SUPERIORITY|PWT was transformed to the log ratio at Week 24:Baseline for statistical analysis.|Mean Difference (Final Values)|-0.021|STANDARD_DEVIATION|0.379||0.727|TWO_SIDED|95.0|-0.138|0.097|||t-test, 2 sided||Mean difference represents the difference of the means of the natural log-transformed ratios between the 2 treatment groups.|||0.097|-0.138|0.727
71847705|NCT01450007|143209903|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
71847706|NCT01450007|143209904|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA|||||||0.001
71847707|NCT01450007|143209905|SUPERIORITY_OR_OTHER|||||||0.76|||||||ANOVA|||||||0.76
71847708|NCT01450007|143209906|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 24 hours.||||0.61
71847709|NCT01450007|143209906|SUPERIORITY_OR_OTHER|||||||0.13|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 48 hours.||||0.13
71847710|NCT01450007|143209906|SUPERIORITY_OR_OTHER|||||||0.25|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 1 week.||||0.25
71847711|NCT01335061|143209907|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||||||<0.0001
71847712|NCT01332266|143209924|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.54|1.46||||||||1.46|0.54|
71847713|NCT01332266|143209926|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.61|1.73||||||||1.73|0.61|
71847714|NCT01332266|143209927|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.53|1.37||||||||1.37|0.53|
71847715|NCT03302091|143209929|OTHER||Adjusted gMean ratio (T/R)%|198.5|STANDARD_DEVIATION|96.5|||TWO_SIDED|90.0|101.83|386.94|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||386.94|101.83|
71847716|NCT03302091|143209930|OTHER||Adjusted gMean ratio (T/R)%|198.42|STANDARD_DEVIATION|77.5|||TWO_SIDED|90.0|116.56|337.78|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||337.78|116.56|
71847717|NCT03302091|143209931|OTHER||Adjusted gMean ratio (T/R)%|226.29|STANDARD_DEVIATION|47.5|||TWO_SIDED|90.0|156.35|327.53|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||327.53|156.35|
71847718|NCT03302091|143209932|OTHER||Adjusted gMean ratio (T/R)%|140.4|STANDARD_DEVIATION|32.8|||TWO_SIDED|90.0|108.06|182.43|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||182.43|108.06|
71847719|NCT03302091|143209933|OTHER||Adjusted gMean ratio (T/R)%|165.63|STANDARD_DEVIATION|56.6|||TWO_SIDED|90.0|107.51|255.17|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||255.17|107.51|
71847720|NCT03302091|143209934|OTHER||Adjusted gMean ratio (T/R)%|128.44|STANDARD_DEVIATION|31.7|||TWO_SIDED|90.0|99.64|165.57|||ANOVA||Standard deviation is actually intra individual geometric coefficient of variation (%).|"The statistical model used for the analyses of the primary endpoints was an ANOVA (analysis of variance) model on the logarithmic scale including the effect degree of renal impairment as a fixed effect as well as subject pair as a random effect."||165.57|99.64|
71847721|NCT01536704|143209935|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.88|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.88|
71847722|NCT01536704|143209935|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.05|||Wilcoxon Signed Rank test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.05|0.98|
71847723|NCT01536704|143209936|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.94|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.94|0.85|
71847724|NCT01536704|143209936|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.02|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.02|0.93|
71847725|NCT01536704|143209937|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.92||||||90.0|0.88|0.95|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||0.95|0.88|
71847726|NCT01536704|143209937|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.98|1.06|||Wilcoxon Signed Rank Test||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.||1.06|0.98|
71847727|NCT01536704|143209938|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0006||||0.1491||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.1491
71847728|NCT01536704|143209938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0005||||0.679||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.6790
71847729|NCT01536704|143209939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0641||||0.5619||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5619
71847730|NCT01536704|143209939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0538||||0.4523||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.4523
71847731|NCT01536704|143209940|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0025||||0.5113||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5113
71847732|NCT01536704|143209940|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.0042||||0.537||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.||||0.5370
71847733|NCT00047385|143209941|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.004|TWO_SIDED|95.0|0.733|0.932||P-value is adjusted for multiple comparisons.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||"Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.~Power: 90% for a 20% reduction in lung cancer mortality."||0.932|0.733|0.004
71847734|NCT00047385|143209942|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.02|TWO_SIDED|95.0|0.864|0.988||No adjustment for multiple comparisons. Only one analysis performed.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.||0.988|0.864|0.02
71847735|NCT00047385|143209943|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.03|1.23|||||Denominator: LDCT Group Numerator: CXR Group|||1.23|1.03|
71847736|NCT01852045|143209965|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.276||0.9949|TWO_SIDED|95.0|-0.549|0.545|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.545|-0.549|0.9949
71678843|NCT03369067|142875732|OTHER|||||||0.038||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.038
71847737|NCT01852045|143209965|SUPERIORITY||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.321||0.9123|TWO_SIDED|95.0|-0.673|0.602|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||0.602|-0.673|0.9123
71847738|NCT01852045|143209967|SUPERIORITY||Least Squares Mean Difference|12.97|STANDARD_ERROR_OF_MEAN|19.694||0.5117|TWO_SIDED|95.0|-26.12|52.064|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||52.064|-26.120|0.5117
71847739|NCT01852045|143209967|SUPERIORITY||Least Squares Mean Difference|65.57|STANDARD_ERROR_OF_MEAN|23.101||0.0055|TWO_SIDED|95.0|19.711|111.421|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||111.421|19.711|0.0055
71847740|NCT01852045|143209969|SUPERIORITY||Least Squares Mean Difference|-13.49|STANDARD_ERROR_OF_MEAN|19.673||0.4948|TWO_SIDED|95.0|-52.605|25.626|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||25.626|-52.605|0.4948
71847741|NCT01852045|143209969|SUPERIORITY||Least Squares Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|22.382||0.9471|TWO_SIDED|95.0|-43.012|45.991|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||45.991|-43.012|0.9471
71847742|NCT01852045|143209970|SUPERIORITY||Relative Risk|0.7||||0.2027|TWO_SIDED|95.0|0.45|1.14||P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (\<12 years or \>=12 years), baseline daytime urinary incontinence episodes (\<=6 or \>6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.14|0.45|0.2027
71678844|NCT03369067|142875732|OTHER|||||||0.016||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.016
71678845|NCT03369067|142875733|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.111
71678846|NCT03369067|142875733|OTHER|||||||0.13||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.130
71898999|NCT02433210|143321324|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Optiflux vs Revaclear.||||<0.001
71899000|NCT02433210|143321324|SUPERIORITY||||||=|0.025||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of beta 2 microglobulin Optiflux vs ELISIO.||||=0.025
71899001|NCT02433210|143321324|SUPERIORITY||||||=|0.903|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of beta 2 microglobulin Revaclear vs ELISIO.||||=0.903
71899002|NCT02433210|143321324|SUPERIORITY||||||=|0.003||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearances of myoglobin Optiflux vs Revaclear.||||=0.003
71899003|NCT02433210|143321324|SUPERIORITY||||||<|0.001||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Optiflux vs ELISIO.||||<0.001
71899004|NCT02433210|143321324|SUPERIORITY||||||=|0.472|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Session 3 Clearance of myoglobin Revaclear vs ELISIO.||||=0.472
71899005|NCT02433210|143321325|SUPERIORITY||||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
71899006|NCT02433210|143321325|SUPERIORITY|No significant difference|||||=|0.216||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.216
71899007|NCT02433210|143321325|SUPERIORITY|No significant difference|||||=|0.952||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.952
71899008|NCT02433210|143321325|SUPERIORITY|No Significant difference|||||=|0.714||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
71899009|NCT02433210|143321325|SUPERIORITY||||||=|0.156||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.156
71899010|NCT02433210|143321325|SUPERIORITY||||||=|0.427||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.427
71899011|NCT02433210|143321325|SUPERIORITY||||||=|0.487||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.487
71899012|NCT02433210|143321325|SUPERIORITY|Failed normality test|||||=|0.111||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|The difference in the median values between the two groups is not \> enough to exclude that the difference is due to random sampling variability||No significant difference||||=0.111
71899013|NCT02433210|143321325|SUPERIORITY|Failed normality test|||||=|0.198||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.198
71899014|NCT02433210|143321325|SUPERIORITY||||||=|0.007||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||Showed a significant difference||||=0.007
71678847|NCT03369067|142875733|OTHER|||||||0.017||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.017
71678848|NCT03369067|142875734|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678849|NCT03369067|142875734|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678850|NCT03369067|142875734|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71815670|NCT02969525|143133596|OTHER||Odds Ratio (OR)|4.2|||=|0.004|TWO_SIDED|95.0|1.59|11.35||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.35|1.59|=0.004
71899015|NCT02433210|143321325|SUPERIORITY||||||=|0.202||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.202
71678851|NCT03369067|142875735|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678852|NCT03369067|142875735|OTHER|||||||0.044||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.044
71678853|NCT03369067|142875735|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678854|NCT03369067|142875736|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678855|NCT03369067|142875736|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678856|NCT03369067|142875736|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678857|NCT03369067|142875737|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678858|NCT03369067|142875737|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678859|NCT03369067|142875737|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678860|NCT03369067|142875738|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71847743|NCT01852045|143209970|SUPERIORITY||Relative Risk|0.8||||0.1564|TWO_SIDED|95.0|0.4|1.21||P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (\< 12 years or \>= 12 years), baseline daytime urinary incontinence episodes (\<= 6 or \> 6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6||1.21|0.40|0.1564
71847744|NCT01852045|143209971|SUPERIORITY||Least Squares Mean Difference|-4.49|STANDARD_ERROR_OF_MEAN|7.488||0.5524|TWO_SIDED|95.0|-19.648|10.669|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||10.669|-19.648|0.5524
71847745|NCT01852045|143209971|SUPERIORITY||Least Squares Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|10.181||0.8313|TWO_SIDED|95.0|-18.427|22.795|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||22.795|-18.427|0.8313
71847746|NCT01852045|143209972|SUPERIORITY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|5.253||0.1737|TWO_SIDED|95.0|-17.653|3.238|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||3.238|-17.653|0.1737
71847747|NCT01852045|143209972|SUPERIORITY||Least Squares Mean Difference|-14.43|STANDARD_ERROR_OF_MEAN|5.85||0.0157|TWO_SIDED|95.0|-26.061|-2.793|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.|||-2.793|-26.061|0.0157
71847748|NCT03052517|143210096|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|1.0|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.00|0.74|
71847749|NCT03052517|143210096|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.72|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.72|
71847750|NCT03052517|143210096|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.09|0.87|
71847751|NCT03052517|143210097|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.76|1.02|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.02|0.76|
71847752|NCT03052517|143210097|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.73|0.99|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.99|0.73|
71847753|NCT03052517|143210097|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.08|0.86|
71847754|NCT03052517|143210098|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.51|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.51|
71847755|NCT03052517|143210098|OTHER||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.39|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.39|
71847756|NCT03052517|143210098|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.14|0.54|
71847757|NCT03052517|143210099|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.54|1.22|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||1.22|0.54|
71847758|NCT03052517|143210099|OTHER||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.41|0.97|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||0.97|0.41|
71847759|NCT03052517|143210099|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.55|1.11|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.11|0.55|
71847760|NCT03052517|143210100|OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.47|2.23|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.23|0.47|
71847761|NCT03052517|143210100|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.59|2.64|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.64|0.59|
71847762|NCT03052517|143210100|OTHER||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.7|2.1|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||2.10|0.70|
71847763|NCT03052517|143210101|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.56|2.56|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 150mg / Placebo||2.56|0.56|
71847764|NCT03052517|143210101|OTHER||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.67|2.95|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / Placebo||2.95|0.67|
71847765|NCT03052517|143210101|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.7|1.96|||Regression, Cox|The Cox regression model = treatment group+ severity of asthma + region as fixed class effects, stratified by randomization stratum|A hazard ratio \< 1 favors the treatment group in the numerator of the ratio.|Hazard Ratio = QAW039 450mg / QAW039 150mg||1.96|0.70|
71847766|NCT03052517|143210102|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.626|1.047|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.047|0.626|
71847767|NCT03052517|143210102|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.622|1.038|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.038|0.622|
71847768|NCT03052517|143210102|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.821|1.2|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.200|0.821|
71847769|NCT03052517|143210103|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.667|1.125|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 150mg /Placebo||1.125|0.667|
71847770|NCT03052517|143210103|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.643|1.082|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /Placebo||1.082|0.643|
71847771|NCT03052517|143210103|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.794|1.167|||Regression, Logistic|Logistic regression model: logit (proportion) = randomization stratum, treatment, severity of asthma, region as fixed effects||Statistical Analysis for Number of patients with at least one AE. Hazard Ratio = QAW039 450mg /QAW039 150mg||1.167|0.794|
71847772|NCT01640288|143210108|OTHER|t-test|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.0349|<|0.0001|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||<0.0001
71847773|NCT01640288|143210109|OTHER|t-test|Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71847774|NCT04803734|143210111|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed Cmax.|Ratio of geometric least square mean|0.862||||0.0328|TWO_SIDED|90.0|0.807|0.922|||ANOVA|||||0.922|0.807|0.0328
71847775|NCT04803734|143210112|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-t).|Ratio of geometric least square mean|0.941|||<|0.0001|TWO_SIDED|90.0|0.909|0.976|||ANOVA|||||0.976|0.909|<0.0001
71847776|NCT04803734|143210113|EQUIVALENCE|To establish bioequivalence of albuterol under fasting conditions, the 90% confidence interval for the ratio of the geometric means between the products should fall within the FDA defined acceptance range of 80.00%-125.00% interval for ln-transformed AUC(0-inf).|Ratio of geometric least square mean|0.942|||<|0.0001|TWO_SIDED|90.0|0.91|0.975|||ANOVA|||||0.975|0.910|<0.0001
71847777|NCT03883724|143210124|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in NPi pre- vs post-intervention comparing between group analysis||||0.3
71899016|NCT02433210|143321325|SUPERIORITY||||||=|0.54||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||No significant difference||||=0.540
71899017|NCT02433210|143321326|SUPERIORITY||||||=|0.204|||||||Wilcoxon (Mann-Whitney)|||||||=0.204
71815671|NCT02969525|143133597|OTHER||Odds Ratio (OR)|2.4|||=|0.279|TWO_SIDED|95.0|0.5|11.31||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||11.31|0.50|=0.279
71899018|NCT02433210|143321326|SUPERIORITY||||||=|0.234|||||||Wilcoxon (Mann-Whitney)|||||||=0.234
71899019|NCT02433210|143321326|SUPERIORITY||||||=|0.015||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the \<0.050 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either then the non-parametric Mann-Whitney Rank Sum Test was used.||||||=0.015
71899020|NCT02433210|143321326|SUPERIORITY||||||=|0.413||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.413
71815672|NCT02969525|143133597|OTHER||Odds Ratio (OR)|4.1|||=|0.065|TWO_SIDED|95.0|0.92|17.88||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||17.88|0.92|=0.065
71815673|NCT02969525|143133597|OTHER||Odds Ratio (OR)|7.5|||=|0.006|TWO_SIDED|95.0|1.77|31.28||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||31.28|1.77|=0.006
71815674|NCT02969525|143133597|OTHER||Odds Ratio (OR)|2.9|||=|0.172|TWO_SIDED|95.0|0.63|13.39||No sequential testing procedure was used for the secondary efficacy variables. The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to Placebo: Odds Ratio, confidence interval, and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure.||13.39|0.63|=0.172
71815675|NCT02172625|143133623|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|26.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
71815676|NCT02172625|143133624|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|15.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
71815677|NCT02172625|143133628|SUPERIORITY_OR_OTHER||week-to-week coefficient of variation %|24.0|||||TWO_SIDED||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.|||||
71815678|NCT00524030|143133629|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||Null hypothesis (H0): Exit rate greater than or equal to (≥)74%||||<0.001
71815679|NCT00524030|143133629|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exite rate ≥68%||||<0.001
71815680|NCT00524030|143133630|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥74%||||<0.001
71815681|NCT00524030|143133630|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood's formula for variance with continuity correction||H0: Exit rate ≥68%||||0.001
71815682|NCT00462670|143133688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.58|-0.6|||t-test, 2 sided|||||-0.60|-1.58|<0.0001
71815683|NCT00462670|143133689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001|TWO_SIDED|95.0|-2.54|-0.92|||t-test, 2 sided|||||-0.92|-2.54|<0.0001
71815684|NCT02110732|143133690|OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71815685|NCT02110732|143133691|SUPERIORITY||||||<|0.05|||||||Chi-squared||||Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level \<0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS.|||< 0.05
71815686|NCT02110732|143133692|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
71815687|NCT01350141|143133708|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-21.81|STANDARD_ERROR_OF_MEAN|8.385||0.0137|TWO_SIDED|95.0|-38.85|-4.77|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-4.77|-38.85|0.0137
71815688|NCT01350141|143133708|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.42|STANDARD_ERROR_OF_MEAN|8.463|<|0.0001|TWO_SIDED|95.0|-63.62|-29.22|||ANCOVA|||Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.||-29.22|-63.62|<0.0001
71815689|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.825||||0.19|TWO_SIDED|95.0|0.36|169.74|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||169.74|0.36|0.1900
71815690|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.518||||0.0057|TWO_SIDED|95.0|3.48|1512.1|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1512.10|3.48|0.0057
71847778|NCT03883724|143210125|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome|||||<|0.01||||||Change in nocturia frequency pre- vs post-intervention comparing between groups BBTI vs IC|ANCOVA|between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||Change in nocturia frequency pre- vs post-intervention comparing between group analysis||||<.01
71847779|NCT03883724|143210126|OTHER|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||||0.3|||||||ANCOVA|ANCOVA between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||between-group analysis was completed comparing of Pre- to Post-Intervention change adjusting for baseline value of the outcome||||0.3
71815691|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.75||||0.0013|TWO_SIDED|95.0|3.49|175.63|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||175.63|3.49|0.0013
71815692|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|47.326||||0.0006|TWO_SIDED|95.0|5.26|426.01|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||426.01|5.26|0.0006
71847780|NCT00195819|143210127|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.1||||0.06||95.0|-0.5|40.7|||Chi-squared|||||40.7|-0.5|0.060
71847781|NCT00195819|143210170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.42||0.387||95.0|||||ANCOVA|||||||0.387
71847782|NCT02037568|143210230|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||.96
71847783|NCT02037568|143210231|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71847784|NCT02037568|143210232|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71847785|NCT02037568|143210233|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71847786|NCT02037568|143210234|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.070
71847787|NCT02037568|143210235|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
71815693|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.635||||0.6611|TWO_SIDED|95.0|0.18|14.73|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||14.73|0.18|0.6611
71815694|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.486||||0.0104|TWO_SIDED|95.0|1.84|98.61|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.61|1.84|0.0104
71847788|NCT02037568|143210236|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71847789|NCT02037568|143210237|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
71847790|NCT02037568|143210238|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71847791|NCT02833948|143210259|SUPERIORITY|||||||0.01|||||||Fisher Exact|The Fisher's exact probability test was used to compare the percentages of patients with the primary end point between the treatment groups.||||||0.01
71847792|NCT02833948|143210263|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
71815695|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0282|TWO_SIDED|95.0|1.22|33.89|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||33.89|1.22|0.0282
71815696|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.257||||0.0042|TWO_SIDED|95.0|2.36|98.42|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||98.42|2.36|0.0042
71847793|NCT00257894|143210269|SUPERIORITY_OR_OTHER|||||||0.57||||||Effect size close to zero (eta squared of .01)|ANOVA|Interaction effect term from group by time ANOVA||||||.57
71847794|NCT00257894|143210270|SUPERIORITY_OR_OTHER|||||||0.6||||||Effect size about zero (eta squared = .01)|ANOVA|Interaction term from a group by time ANOVA||||||.60
71847795|NCT00257894|143210271|SUPERIORITY_OR_OTHER|||||||0.79||||||Effect size (eta squared) = 0|ANOVA|Interaction term of a group by time ANOVA||||||.79
71847796|NCT00257894|143210272|SUPERIORITY_OR_OTHER|||||||0.21||||||For test of drug by time interaction effect|ANOVA|Medium effect size, eta squared = .061||Analysis of variance, group by time (Day 0 vs. Day 10).||||.21
71847797|NCT02852824|143210275|OTHER||Slope|0.9058|STANDARD_ERROR_OF_MEAN|0.0523|||TWO_SIDED|95.0|0.7973|1.0142||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used a statistical method.||1.0142|0.7973|
71847798|NCT02852824|143210276|OTHER||Slope|0.9528|STANDARD_ERROR_OF_MEAN|0.0454|||TWO_SIDED|95.0|0.8581|1.0475||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0475|0.8581|
71847799|NCT02852824|143210277|OTHER||Slope|0.9439|STANDARD_ERROR_OF_MEAN|0.0358|||TWO_SIDED|95.0|0.8697|1.0182||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0182|0.8697|
71815697|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.967||||0.5164|TWO_SIDED|95.0|0.11|79.24|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||79.24|0.11|0.5164
71815698|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.36||||0.0445|TWO_SIDED|95.0|1.08|422.94|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||422.94|1.08|0.0445
71815699|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.157||||0.0223|TWO_SIDED|95.0|1.35|49.37|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||49.37|1.35|0.0223
71815700|NCT01350141|143133709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.587||||0.007|TWO_SIDED|95.0|2.04|90.4|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||90.40|2.04|0.0070
71815701|NCT01350141|143133710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.647||||0.2928|TWO_SIDED|95.0|0.22|142.04|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||142.04|0.22|0.2928
71847800|NCT02852824|143210278|OTHER||Slope|0.9708|STANDARD_ERROR_OF_MEAN|0.0351|||TWO_SIDED|95.0|0.8975|1.044||||||Dose proportionality was explored using a regression model. A 95% confidence interval (CI) for the slope was computed. Power model is used as statistical method.||1.0440|0.8975|
71847801|NCT03787628|143210284|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.703||||0.41|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of cue-induced craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on the measure of cue-induced craving (degrees of freedom = 1, 67).|||||0.41
71847802|NCT03787628|143210285|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.0||||0.99|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of spontaneous craving.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on spontaneous craving (degrees of freedom = 1, 550).|||||0.99
71847803|NCT03787628|143210286|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.04||||0.84|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of state anxiety.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on state anxiety (degrees of freedom = 1, 550)|||||0.84
71847804|NCT03787628|143210287|OTHER|Generalized linear mixed model (GLMM) testing the main effect of group and time, and the group X time interaction.|F-test|0.27||||0.6|TWO_SIDED|||||P-value reflects the test of the interaction between group and time on the measure of negative affect.|Mixed Models Analysis||Estimated value reflects the f test of the interaction between group and time on negative affect (degrees of freedom = 1, 550).|||||0.60
71847805|NCT00768716|143210311|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71847806|NCT00768716|143210312|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71847807|NCT00768716|143210313|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71847808|NCT00768716|143210315|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71847809|NCT00768716|143210316|OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71847810|NCT00768716|143210317|OTHER|||||||0.003|||||||ANOVA|||||||0.003
71847811|NCT03769090|143210318|SUPERIORITY||Hazard Ratio (HR)|0.733|||<|0.001|TWO_SIDED|95.0|0.611|0.879|||Regression, Cox|||H0 = null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDA MDI treatment.||0.879|0.611|<0.001
71847812|NCT03769090|143210318|SUPERIORITY||Hazard Ratio (HR)|0.835||||0.041|TWO_SIDED|95.0|0.702|0.992|||Regression, Cox|||H0 = Null hypothesis. Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, age group, region and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favours BDI MDI treatment.||0.992|0.702|0.041
71847813|NCT03769090|143210319|SUPERIORITY||Rate Ratio|0.76||||0.008|TWO_SIDED|95.0|0.62|0.93|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.93|0.62|0.008
71847814|NCT03769090|143210319|SUPERIORITY||Rate Ratio|0.8||||0.028|TWO_SIDED|95.0|0.66|0.98|||Negative binomial model|||Estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||0.98|0.66|0.028
71899021|NCT02433210|143321326|SUPERIORITY||||||=|0.314||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.314
71815702|NCT01350141|143133710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|591.174||||0.0014|TWO_SIDED|95.0|11.68|29922.99|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||29922.99|11.68|0.0014
71815703|NCT01350141|143133710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.468||||0.2339|TWO_SIDED|95.0|0.45|26.88|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||26.88|0.45|0.2339
71815704|NCT01350141|143133710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|23.442||||0.0025|TWO_SIDED|95.0|3.03|181.11|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||181.11|3.03|0.0025
71815705|NCT01350141|143133710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.502||||0.1786|TWO_SIDED|95.0|0.38|192.32|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||192.32|0.38|0.1786
71815706|NCT01350141|143133710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|51.185||||0.0121|TWO_SIDED|95.0|2.37|1107.57|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.||1107.57|2.37|0.0121
71815707|NCT01588990|143133722|SUPERIORITY_OR_OTHER|||||||0.101|||||||Cox Proportional Hazards Model|||||||0.101
71815708|NCT01588990|143133734|SUPERIORITY_OR_OTHER|||||||0.052|||||||Cox Proportional Hazards Model|||||||0.052
71815709|NCT01588990|143133735|SUPERIORITY_OR_OTHER|||||||0.797|||||||Cox Proportional Hazards Model|||||||0.797
71847815|NCT03769090|143210320|SUPERIORITY|||||||0.002|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.002
71847816|NCT03769090|143210320|SUPERIORITY|||||||0.06|||||||Wilcoxon rank sum|||P-values are calculated via a Wilcoxon rank sum test. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||||0.06
71847817|NCT03769090|143210321|SUPERIORITY||Odds Ratio (OR)|1.221||||0.033|TWO_SIDED|95.0|1.016|1.467|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.467|1.016|0.033
71847818|NCT03769090|143210321|SUPERIORITY||Odds Ratio (OR)|1.132||||0.175|TWO_SIDED|95.0|0.946|1.353|||Regression, Logistic|||Logistic regression model with baseline ACQ-5 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.353|0.946|0.175
71847819|NCT03769090|143210322|SUPERIORITY||Odds Ratio (OR)|1.228||||0.028|TWO_SIDED|95.0|1.022|1.475|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.475|1.022|0.028
71847820|NCT03769090|143210322|SUPERIORITY||Odds Ratio (OR)|1.111||||0.26|TWO_SIDED|95.0|0.925|1.335|||Regression, Logistic|||Logistic regression model with baseline AQLQ-12 as a continuous covariate and age group, region and number of severe exacerbations in the 12 months prior to randomization as categorical covariates. A sequential testing strategy is used for secondary endpoints. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected.||1.335|0.925|0.26
71847821|NCT00799409|143210323|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.6|||<|0.0001|TWO_SIDED|95.0|-35.0|-22.3||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.3|-35.0|<0.0001
71847822|NCT00799409|143210324|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.3|||<|0.0001|TWO_SIDED|95.0|-34.4|-22.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA|||-22.2|-34.4|<0.0001
71847823|NCT00799409|143210325|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9|||<|0.0001|TWO_SIDED|95.0|4.3|7.4||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||7.4|4.3|<0.0001
71899022|NCT02433210|143321326|SUPERIORITY||||||=|0.769||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.769
71899023|NCT02433210|143321327|SUPERIORITY||||||=|0.376|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.376
71899024|NCT02433210|143321327|SUPERIORITY|||||||1||||||The p value was not adjusted for multiple comparisons and the difference was considered significant at the p\<0.05 level.|Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||1.000
71899025|NCT02433210|143321327|SUPERIORITY|||||||0.713|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||0.713
71678861|NCT03369067|142875738|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71815710|NCT01588990|143133736|SUPERIORITY_OR_OTHER|||||||0.188|||||||Cox Proportional Hazards Model|||||||0.188
71815711|NCT01588990|143133737|SUPERIORITY_OR_OTHER|||||||0.016|||||||Cox Proportional Hazards Model|||||||0.016
71815712|NCT02367716|143133752|OTHER|The mean change in QRS duration between Baseline and 6 months|Mean Difference (Final Values)|-13.9|STANDARD_DEVIATION|29.6|||TWO_SIDED|||||||||||||
71815713|NCT01187329|143133760|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.11|TWO_SIDED|97.5|-2.87|0.48|||t-test, 2 sided|||||0.48|-2.87|0.11
71815714|NCT01187329|143133761|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.007|TWO_SIDED|97.5|-0.3|-0.01|||t-test, 2 sided|paired t-test||||-0.01|-0.3|0.007
71815715|NCT01187329|143133762|SUPERIORITY||Median Difference (Final Values)|-0.6||||0.57|TWO_SIDED|95.0|-2.6|1.5|||t-test, 2 sided|||||1.5|-2.6|0.57
71815716|NCT01187329|143133763|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.45|TWO_SIDED|95.0|-0.2|0.1|||t-test, 2 sided|||||0.1|-0.2|0.45
71847824|NCT00799409|143210326|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|3.8|6.5||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||6.5|3.8|<0.0001
71815717|NCT00868699|143133767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
71815718|NCT00868699|143133767|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
71815719|NCT00868699|143133768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
71815720|NCT00868699|143133768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
71815721|NCT00868699|143133769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.003|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||0.003
71815722|NCT00868699|143133769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.|||||<0.001
71815723|NCT03635489|143133831|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53|||Regression, Cox|||||0.53|0.17|<.0001
71815724|NCT03635489|143133831|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.58|||Regression, Cox|||||0.58|0.20|<.0001
71815725|NCT03635489|143133832|SUPERIORITY|Unstratified analysis|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.3|1.21||||||||1.21|0.30|
71815726|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.0||||0.4788|TWO_SIDED|95.0|-284.8|134.9|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 1||134.9|-284.8|0.4788
71815727|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|124.1||||0.2309|TWO_SIDED|95.0|-80.6|328.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 1||328.9|-80.6|0.2309
71815728|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-185.1||||0.0758|TWO_SIDED|95.0|-389.8|19.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 1||19.7|-389.8|0.0758
71815729|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Median Difference (Net)|130.4||||0.2084|TWO_SIDED|95.0|-74.4|335.1|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 1||335.1|-74.4|0.2084
71815730|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|132.6||||0.1684|TWO_SIDED|95.0|-57.4|322.6|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 1||322.6|-57.4|0.1684
71899026|NCT02433210|143321327|SUPERIORITY||||||=|0.424|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.424
71899027|NCT02433210|143321327|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.230
71815731|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-90.4||||0.5122|TWO_SIDED|95.0|-364.7|184.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 2||184.0|-364.7|0.5122
71815732|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-75.5||||0.5417|TWO_SIDED|95.0|-321.7|170.7|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 2||170.7|-321.7|0.5417
71815733|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.4||||0.6511|TWO_SIDED|95.0|-294.2|185.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 2||185.3|-294.2|0.6511
71815734|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|64.7||||0.6117|TWO_SIDED|95.0|-189.1|318.5|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 2||318.5|-189.1|0.6117
71815735|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-99.7||||0.3882|TWO_SIDED|95.0|-329.3|129.9|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 2||129.9|-329.3|0.3882
71815736|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-125.5||||0.4781|TWO_SIDED|95.0|-477.5|226.5|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH effect||226.5|-477.5|0.4781
71815737|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-277.9||||0.0834|TWO_SIDED|95.0|-593.7|37.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH effect||37.9|-593.7|0.0834
71815738|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|121.7||||0.4313|TWO_SIDED|95.0|-185.8|429.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH effect||429.3|-185.8|0.4313
71815739|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-73.5||||0.6528|TWO_SIDED|95.0|-399.1|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH effect||252.0|-399.1|0.6528
71815740|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-248.5||||0.0966|TWO_SIDED|95.0|-542.9|46.0|||Mixed Models Analysis|||Placebo versus Asacol for ACTH effect||46.0|-542.9|0.0966
71815741|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.2||||0.7704|TWO_SIDED|95.0|-187.6|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH morning||252.0|-187.6|0.7704
71815742|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|165.3||||0.0988|TWO_SIDED|95.0|-32.0|362.5|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH morning||362.5|-32.0|0.0988
71815743|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-153.4||||0.1153|TWO_SIDED|95.0|-345.5|38.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH morning||38.7|-345.5|0.1153
71847825|NCT00799409|143210327|SUPERIORITY_OR_OTHER||LS Mean Difference|11.0|||<|0.0001|TWO_SIDED|95.0|8.7|13.3||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA|||13.3|8.7|<0.0001
71847826|NCT00799409|143210328|SUPERIORITY_OR_OTHER||LS Means Difference|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.59||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.59|-3.72|<0.0001
71815744|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.7||||0.9636|TWO_SIDED|95.0|-198.7|208.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH morning||208.0|-198.7|0.9636
71847827|NCT00799409|143210329|SUPERIORITY_OR_OTHER||LS Means Difference|-16.03|||<|0.0001|TWO_SIDED|95.0|-19.99|-12.06||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-12.06|-19.99|<0.0001
71847828|NCT00799409|143210330|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.45|||<|0.0001|TWO_SIDED|95.0|-27.43|-17.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-17.47|-27.43|<0.0001
71815745|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|119.8||||0.1972|TWO_SIDED|95.0|-64.1|303.8|||Mixed Models Analysis|||Placebo versus Asacol for ACTH morning||303.8|-64.1|0.1972
71815746|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-207.6||||0.0495|TWO_SIDED|95.0|-414.6|-0.5|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 1||-0.5|-414.6|0.0495
71815747|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.5||||0.9333|TWO_SIDED|95.0|-210.4|193.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 1||193.4|-210.4|0.9333
71815748|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-317.7||||0.0025|TWO_SIDED|95.0|-519.6|-115.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 1||-115.8|-519.6|0.0025
71815749|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.9823|TWO_SIDED|95.0|-204.1|199.6|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 1||199.6|-204.1|0.9823
71815750|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.3||||0.946|TWO_SIDED|95.0|-265.0|283.7|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 2||283.7|-265.0|0.9460
71847829|NCT00799409|143210331|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.93||||0.18|TWO_SIDED|95.0|-1.69|-0.16||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.16|-1.69|0.1800
71847830|NCT00799409|143210332|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32||||0.0057|TWO_SIDED|95.0|-2.25|-0.4||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.40|-2.25|0.0057
71847831|NCT00799409|143210333|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.1091|TWO_SIDED|95.0|-14.05|1.44||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||1.44|-14.05|0.1091
71847832|NCT00799409|143210334|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.2653|TWO_SIDED|95.0|-0.7|0.2||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.20|-0.70|0.2653
71847833|NCT00799409|143210335|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.49||||0.0038|TWO_SIDED|95.0|-10.81|-2.17||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.17|-10.81|0.0038
71815751|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.2||||0.8445|TWO_SIDED|95.0|-222.0|270.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 2||270.4|-222.0|0.8445
71815752|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.3||||0.7069|TWO_SIDED|95.0|-194.5|285.0|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 2||285.0|-194.5|0.7069
71815753|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|164.4||||0.1998|TWO_SIDED|95.0|-89.4|418.2|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 2||418.2|-89.4|0.1998
71815754|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|123.0||||0.4871|TWO_SIDED|95.0|-229.0|474.9|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH effect||474.9|-229.0|0.4871
71815755|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.4||||0.8527|TWO_SIDED|95.0|-345.2|286.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH effect||286.4|-345.2|0.8527
71815756|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|370.2||||0.0192|TWO_SIDED|95.0|62.6|677.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH effect||677.8|62.6|0.0192
71815757|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|174.9||||0.2865|TWO_SIDED|95.0|-150.6|500.5|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH effect||500.5|-150.6|0.2865
71815758|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-87.6||||0.4279|TWO_SIDED|95.0|-307.5|132.2|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH morning||132.2|-307.5|0.4279
71815759|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|45.4||||0.6464|TWO_SIDED|95.0|-151.8|242.7|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH morning||242.7|-151.8|0.6464
71815760|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-273.3||||0.0061|TWO_SIDED|95.0|-465.4|-81.2|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH morning||-81.2|-465.4|0.0061
71815761|NCT01036022|143133903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-115.2||||0.2614|TWO_SIDED|95.0|-318.5|88.1|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH morning||88.1|-318.5|0.2614
71815762|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.7559|TWO_SIDED|95.0|-2.0|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 1 SCCAI score||1.5|-2.0|0.7559
71815763|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.1238|TWO_SIDED|95.0|-0.4|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 1 SCCAI score||3.2|-0.4|0.1238
71815764|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6302|TWO_SIDED|95.0|-1.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 1 SCCAI score||2.2|-1.3|0.6302
71815765|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.2777|TWO_SIDED|95.0|-0.8|2.8|||Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 1 SCCAI score||2.8|-0.8|0.2777
71815766|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8069|TWO_SIDED|95.0|-1.4|1.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 1 SCCAI score||1.8|-1.4|0.8069
71815767|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7699|TWO_SIDED|95.0|-1.6|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 2 SCCAI score||2.2|-1.6|0.7699
71815768|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3869|TWO_SIDED|95.0|-1.1|2.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 2 SCCAI score||2.8|-1.1|0.3869
71815769|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.6695|TWO_SIDED|95.0|-2.4|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 2 SCCAI score||1.5|-2.4|0.6695
71815770|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.5152|TWO_SIDED|95.0|-1.4|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 2 SCCAI score||2.7|-1.4|0.5152
71815771|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.4507|TWO_SIDED|95.0|-2.4|1.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 2 SCCAI score||1.1|-2.4|0.4507
71815772|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8707|TWO_SIDED|95.0|-1.9|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 3 SCCAI score||2.3|-1.9|0.8707
71815773|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.2915|TWO_SIDED|95.0|-0.9|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 3 SCCAI score||3.1|-0.9|0.2915
71847834|NCT00799409|143210336|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.75||||0.0001|TWO_SIDED|95.0|-6.96|-2.53||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-2.53|-6.96|0.0001
71815774|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.7251|TWO_SIDED|95.0|-2.4|1.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 3 SCCAI score||1.7|-2.4|0.7251
71815775|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4556|TWO_SIDED|95.0|-1.3|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 3 SCCAI score||2.9|-1.3|0.4556
71815776|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.662|TWO_SIDED|95.0|-2.3|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 3 SCCAI score||1.4|-2.3|0.6620
71815777|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2844|TWO_SIDED|95.0|-1.1|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 4 SCCAI score||3.5|-1.1|0.2844
71815778|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2799|TWO_SIDED|95.0|-1.0|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 4 SCCAI score||3.5|-1.0|0.2799
71815779|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.7655|TWO_SIDED|95.0|-1.9|2.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 4 SCCAI score||2.6|-1.9|0.7655
71847835|NCT00799409|143210337|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76||||0.0092|TWO_SIDED|95.0|-10.04|-1.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-1.47|-10.04|0.0092
71899028|NCT02433210|143321327|SUPERIORITY||||||=|0.678|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.678
71815780|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3332|TWO_SIDED|95.0|-1.2|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 4 SCCAI score||3.5|-1.2|0.3332
71815781|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.6985|TWO_SIDED|95.0|-1.6|2.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 4 SCCAI score||2.4|-1.6|0.6985
71815782|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.3256|TWO_SIDED|95.0|-1.3|3.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 5 SCCAI score||3.7|-1.3|0.3256
71815783|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.65|TWO_SIDED|95.0|-1.9|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 5 SCCAI score||3.0|-1.9|0.6500
71678862|NCT03369067|142875738|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678863|NCT03369067|142875739|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678864|NCT03369067|142875739|OTHER|||||||0.141||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.141
71815784|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.8758|TWO_SIDED|95.0|-2.3|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 5 SCCAI score||2.7|-2.3|0.8758
71815785|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.7298|TWO_SIDED|95.0|-2.1|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 5 SCCAI score||3.0|-2.1|0.7298
71815786|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.5963|TWO_SIDED|95.0|-2.8|1.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 5 SCCAI score||1.6|-2.8|0.5963
71815787|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6498|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 6 SCCAI score||3.1|-2.0|0.6498
71815788|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.7061|TWO_SIDED|95.0|-2.0|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 6 SCCAI score||3.0|-2.0|0.7061
71899029|NCT02433210|143321327|SUPERIORITY||||||=|0.643|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.643
71815789|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.8549|TWO_SIDED|95.0|-2.7|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 6 SCCAI score||2.3|-2.7|0.8549
71815790|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6533|TWO_SIDED|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 6 SCCAI score||3.1|-2.0|0.6533
71815791|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.4378|TWO_SIDED|95.0|-3.1|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 6 SCCAI score||1.4|-3.1|0.4378
71815792|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.5917|TWO_SIDED|95.0|-2.2|1.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 1 SCCAI score||1.3|-2.2|0.5917
71815793|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.1764|TWO_SIDED|95.0|-0.5|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 1 SCCAI score||2.9|-0.5|0.1764
71815794|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7914|TWO_SIDED|95.0|-1.5|2.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 1 SCCAI score||2.0|-1.5|0.7914
71899030|NCT02433210|143321327|SUPERIORITY||||||=|0.43|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.430
71678865|NCT03369067|142875739|OTHER|||||||0.149||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.149
71678866|NCT03369067|142875740|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678867|NCT03369067|142875740|OTHER|||||||0.094||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||0.094
71678868|NCT03369067|142875740|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678869|NCT03369067|142875741|OTHER||||||<|0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||<0.001
71678870|NCT03369067|142875741|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678871|NCT03369067|142875741|OTHER|||||||0.033||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.033
71678872|NCT03369067|142875742|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
71899031|NCT02433210|143321327|SUPERIORITY||||||=|0.295|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.295
71899032|NCT02433210|143321327|SUPERIORITY||||||=|0.723|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.723
71899033|NCT02433210|143321327|SUPERIORITY||||||=|0.749|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.749
71899034|NCT02433210|143321327|SUPERIORITY||||||=|0.967|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.967
71899035|NCT02433210|143321328|SUPERIORITY||||||=|0.67|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.670
71899036|NCT02433210|143321328|SUPERIORITY||||||=|0.993|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.993
71899037|NCT02433210|143321328|SUPERIORITY||||||=|0.65|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.650
71899038|NCT02433210|143321328|SUPERIORITY||||||=|0.299|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.299
71899039|NCT02433210|143321328|SUPERIORITY||||||=|0.659|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.659
71899040|NCT02433210|143321328|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
71899041|NCT02433210|143321328|SUPERIORITY||||||=|0.853|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.853
71899042|NCT02433210|143321328|SUPERIORITY||||||=|0.494|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.494
71899043|NCT02433210|143321328|SUPERIORITY||||||=|0.631|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.631
71899044|NCT02433210|143321328|SUPERIORITY||||||=|0.37|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.370
71899045|NCT02433210|143321328|SUPERIORITY||||||=|0.95|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.950
71899046|NCT02433210|143321328|SUPERIORITY||||||=|0.377|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.377
71899047|NCT02433210|143321329|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
71899048|NCT02433210|143321329|SUPERIORITY||||||=|0.578|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.578
71899049|NCT02433210|143321329|SUPERIORITY||||||=|0.225|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.225
71899050|NCT02433210|143321329|SUPERIORITY||||||=|0.125|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.125
71899051|NCT02433210|143321329|SUPERIORITY||||||=|0.466|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.466
71899052|NCT02433210|143321329|SUPERIORITY||||||=|0.534|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.534
71899053|NCT02433210|143321329|SUPERIORITY||||||=|0.584|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.584
71899054|NCT02433210|143321329|SUPERIORITY||||||=|0.981|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.981
71899055|NCT02433210|143321329|SUPERIORITY||||||=|0.568|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.568
71899056|NCT02433210|143321329|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.240
71899057|NCT02433210|143321329|SUPERIORITY||||||=|0.724|||||||Wilcoxon (Mann-Whitney)|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.724
71899058|NCT02433210|143321329|SUPERIORITY||||||=|0.445|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.445
71899059|NCT02433210|143321330|SUPERIORITY||||||=|0.114|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.114
71815795|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.3578|TWO_SIDED|95.0|-0.9|2.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 1 SCCAI score||2.5|-0.9|0.3578
71815796|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.3247|TWO_SIDED|95.0|-1.0|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 2 SCCAI score||2.9|-1.0|0.3247
71815797|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1153|TWO_SIDED|95.0|-0.4|3.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 2 SCCAI score||3.4|-0.4|0.1153
71815798|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7995|TWO_SIDED|95.0|-1.7|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 2 SCCAI score||2.2|-1.7|0.7995
71815799|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.1786|TWO_SIDED|95.0|-0.6|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 2 SCCAI score||3.3|-0.6|0.1786
71815800|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.5824|TWO_SIDED|95.0|-1.5|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 3 SCCAI score||2.7|-1.5|0.5824
71815801|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1392|TWO_SIDED|95.0|-0.5|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 3 SCCAI score||3.5|-0.5|0.1392
71815802|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9665|TWO_SIDED|95.0|-2.0|2.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 3 SCCAI score||2.1|-2.0|0.9665
71815803|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.2455|TWO_SIDED|95.0|-0.9|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 3 SCCAI score||3.3|-0.9|0.2455
71815804|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4644|TWO_SIDED|95.0|-1.4|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 4 SCCAI score||3.1|-1.4|0.4644
71815805|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.4567|TWO_SIDED|95.0|-1.4|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 4 SCCAI score||3.0|-1.4|0.4567
71847836|NCT00799409|143210338|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.9195|TWO_SIDED|95.0|-0.37|0.33||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.33|-0.37|0.9195
71847837|NCT00799409|143210339|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.55||||0.0002|TWO_SIDED|95.0|-59.7|-19.39||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-19.39|-59.70|0.0002
71847838|NCT00799409|143210340|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.0002|TWO_SIDED|95.0|-0.13|-0.04||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.04|-0.13|0.0002
71847839|NCT00799409|143210341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.4625|TWO_SIDED|95.0|-0.07|0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.03|-0.07|0.4625
71847840|NCT00799409|143210342|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02||||0.6262|TWO_SIDED|95.0|-0.09|0.05||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.05|-0.09|0.6262
71847841|NCT00799409|143210343|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.998|TWO_SIDED|95.0|-0.08|0.08||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.08|-0.08|0.9980
71847842|NCT00799409|143210344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.0151|TWO_SIDED|95.0|-0.19|-0.02||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.02|-0.19|0.0151
71815806|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9594|TWO_SIDED|95.0|-2.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 4 SCCAI score||2.2|-2.3|0.9594
71815807|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5122|TWO_SIDED|95.0|-1.5|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 4 SCCAI score||3.0|-1.5|0.5122
71847843|NCT00799409|143210345|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09||||0.0043|TWO_SIDED|95.0|-0.15|-0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||-0.03|-0.15|0.0043
71847844|NCT00799409|143210346|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.0371|TWO_SIDED|95.0|-0.08|0.0||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.00|-0.08|0.0371
71847845|NCT00799409|143210347|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.0965|TWO_SIDED|95.0|-0.06|0.01||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA|||0.01|-0.06|0.0965
71847846|NCT02713594|143210352|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.86|||<|0.0001|TWO_SIDED|95.0|-11.28|-4.5|||Abstinence Risk Difference|||||-4.5|-11.28|<.0001
71847847|NCT02713594|143210353|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|Chi-square test value = 196.1, with 5 degrees of freedom.||||||<.0001
71815808|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.1493|TWO_SIDED|95.0|-0.7|4.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 5 SCCAI score||4.3|-0.7|0.1493
71815809|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.3478|TWO_SIDED|95.0|-1.3|3.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 5 SCCAI score||3.6|-1.3|0.3478
71815810|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.5238|TWO_SIDED|95.0|-1.7|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 5 SCCAI score||3.2|-1.7|0.5238
71815811|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.4091|TWO_SIDED|95.0|-1.4|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 5 SCCAI score||3.5|-1.4|0.4091
71815812|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.2604|TWO_SIDED|95.0|-1.1|4.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 6 SCCAI score||4.0|-1.1|0.2604
71815813|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.2809|TWO_SIDED|95.0|-1.1|3.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 6 SCCAI score||3.8|-1.1|0.2809
71815814|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.6038|TWO_SIDED|95.0|-1.8|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 6 SCCAI score||3.1|-1.8|0.6038
71815815|NCT01036022|143133905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.2511|TWO_SIDED|95.0|-1.1|3.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 6 SCCAI score||3.9|-1.1|0.2511
71815816|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.75|||||TWO_SIDED|95.0|0.24|2.39||||||Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels||2.39|0.24|
71815817|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.21|1.92||||||Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels||1.92|0.21|
71815818|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.8|||||TWO_SIDED|95.0|0.26|2.48||||||Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels||2.48|0.26|
71815819|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.27|2.68||||||Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels||2.68|0.27|
71815820|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.23|1.81||||||Placebo versus Asacol for Week 1 fecal calprotectin levels||1.81|0.23|
71815821|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.85|||||TWO_SIDED|95.0|0.26|2.73||||||Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels||2.73|0.26|
71815822|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.55|||||TWO_SIDED|95.0|0.18|1.68||||||Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels||1.68|0.18|
71815823|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.67|||||TWO_SIDED|95.0|0.21|2.18||||||Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels||2.18|0.21|
71815824|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.19|2.03||||||Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels||2.03|0.19|
71815825|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.22|1.9||||||Placebo versus Asacol for Week 2 fecal calprotectin levels||1.90|0.22|
71815826|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|1.07|||||TWO_SIDED|95.0|0.28|4.09||||||Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels||4.09|0.28|
71815827|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.74|||||TWO_SIDED|95.0|0.23|2.43||||||Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels||2.43|0.23|
71815828|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.62|||||TWO_SIDED|95.0|0.18|2.08||||||Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels||2.08|0.18|
71815829|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.6|||||TWO_SIDED|95.0|0.17|2.08||||||Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels||2.08|0.17|
71815830|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.15|1.32||||||Placebo versus Asacol for Week 3 fecal calprotectin levels||1.32|0.15|
71815831|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|95.0|0.33|5.04||||||Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels||5.04|0.33|
71815832|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.64|||||TWO_SIDED|95.0|0.2|2.02||||||Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels||2.02|0.20|
71815833|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.29|3.23||||||Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels||3.23|0.29|
71815834|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|1.36|||||TWO_SIDED|95.0|0.39|4.72||||||Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels||4.72|0.39|
71815835|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.28|2.42||||||Placebo versus Asacol for Week 4 fecal calprotectin levels||2.42|0.28|
71815836|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.61|||||TWO_SIDED|95.0|0.14|2.66||||||Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels||2.66|0.14|
71815837|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.35|4.38||||||Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels||4.38|0.35|
71815838|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.2|2.47||||||Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels||2.47|0.20|
71815839|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.46||||||Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels||1.46|0.11|
71815840|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.47|||||TWO_SIDED|95.0|0.15|1.48||||||Placebo versus Asacol for Week 5 fecal calprotectin levels||1.48|0.15|
71815841|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.66|||||TWO_SIDED|95.0|0.13|3.39||||||Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels||3.39|0.13|
71815842|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.11|1.84||||||Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels||1.84|0.11|
71815843|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.09|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels||1.48|0.09|
71815844|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.19|2.99||||||Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels||2.99|0.19|
71815845|NCT01036022|143133908|SUPERIORITY_OR_OTHER||Ratio|0.72|||||TWO_SIDED|95.0|0.21|2.49||||||Placebo versus Asacol for Week 6 fecal calprotectin levels||2.49|0.21|
71847848|NCT03928743|143210402|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.71|4.87|||Regression, Logistic|||||4.87|1.71|<0.001
71847849|NCT03928743|143210403|SUPERIORITY||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|1.59|4.93|||Regression, Logistic|||||4.93|1.59|<0.001
71847850|NCT03928743|143210404|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Regression, Logistic|||||4.28|1.65|<0.001
71847851|NCT03928743|143210405|SUPERIORITY||LS Mean difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.48|-0.59|||Regression, Logistic|||||-0.59|-1.48|<0.001
71847852|NCT03928743|143210406|SUPERIORITY||Odds Ratio (OR)|4.26|||<|0.001|TWO_SIDED|95.0|1.93|9.39|||Regression, Logistic|||||9.39|1.93|<0.001
71847853|NCT03928743|143210407|SUPERIORITY||Odds Ratio (OR)|6.47|||<|0.001|TWO_SIDED|95.0|2.67|15.65|||Regression, Logistic|||||15.65|2.67|<0.001
71847854|NCT03928743|143210408|SUPERIORITY||Odds Ratio (OR)|4.65|||<|0.001|TWO_SIDED|4.65|2.51|7.57|||Regression, Logistic|||||7.57|2.51|<0.001
71815846|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.42|3.38||||||Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels||3.38|0.42|
71815847|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.35|||||TWO_SIDED|95.0|0.5|3.65||||||Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels||3.65|0.50|
71815848|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.25|||||TWO_SIDED|95.0|0.45|3.47||||||Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels||3.47|0.45|
71815849|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.26|||||TWO_SIDED|95.0|0.44|3.59||||||Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels||3.59|0.44|
71815850|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.28|||||TWO_SIDED|95.0|0.5|3.28||||||Placebo versus Asacol for Week 1 fecal lactoferrin levels||3.28|0.50|
71815851|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.76|||||TWO_SIDED|95.0|0.26|2.19||||||Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels||2.19|0.26|
71815852|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.59|||||TWO_SIDED|95.0|0.22|1.63||||||Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels||1.63|0.22|
71815853|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.35|||||TWO_SIDED|95.0|0.12|1.0||||||Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels||1.00|0.12|
71815854|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.93|||||TWO_SIDED|95.0|0.31|2.77||||||Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels||2.77|0.31|
71815855|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.26|1.87||||||Placebo versus Asacol for Week 2 fecal lactoferrin levels||1.87|0.26|
71815856|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.53|||||TWO_SIDED|95.0|0.15|1.84||||||Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels||1.84|0.15|
71815857|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.96|||||TWO_SIDED|95.0|0.32|2.87||||||Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels||2.87|0.32|
71815858|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.52|||||TWO_SIDED|95.0|0.17|1.56||||||Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels||1.56|0.17|
71847855|NCT03928743|143210409|SUPERIORITY||LS Mean difference|-1.05|||<|0.001|TWO_SIDED|95.0|-1.48|-0.63|||Regression, Logistic|||||-0.63|-1.48|<0.001
71847856|NCT03928743|143210410|SUPERIORITY||LS Mean difference|-1.48|||<|0.001|TWO_SIDED|95.0|-2.0|-0.96|||Regression, Logistic|||||-0.96|-2.00|<0.001
71815859|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.42|||||TWO_SIDED|95.0|0.45|4.46||||||Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels||4.46|0.45|
71815860|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.37|||||TWO_SIDED|95.0|0.14|1.01||||||Placebo versus Asacol for Week 3 fecal lactoferrin levels||1.01|0.14|
71815861|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.1|1.15||||||Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels||1.15|0.10|
71815862|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.68|||||TWO_SIDED|95.0|0.23|2.03||||||Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels||2.03|0.23|
71815863|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.19|1.68||||||Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels||1.68|0.19|
71815864|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.19|||||TWO_SIDED|95.0|0.38|3.7||||||Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels||3.70|0.38|
71815865|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.71|||||TWO_SIDED|95.0|0.26|1.89||||||Placebo versus Asacol for Week 4 fecal lactoferrin levels||1.89|0.26|
71815866|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.05|||||TWO_SIDED|95.0|0.27|4.07||||||Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels||4.07|0.27|
71847857|NCT03928743|143210411|SUPERIORITY||LS Mean difference|-1.52|||<|0.001|TWO_SIDED|95.0|-2.36|-0.68|||Regression, Logistic|||||-0.68|-2.36|<0.001
71847858|NCT03928743|143210412|SUPERIORITY||LS Mean difference|3.38|||<|0.001|TWO_SIDED|95.0|1.67|5.09|||Regression, Logistic|||||5.09|1.67|<0.001
71847859|NCT03928743|143210413|SUPERIORITY||LS Mean difference|-0.28||||0.006|TWO_SIDED|95.0|-0.47|-0.08|||Regression, Logistic|||||-0.08|-0.47|0.006
71847860|NCT03928743|143210414|SUPERIORITY||LS Mean difference|-1.08||||0.003|TWO_SIDED|95.0|-1.79|-0.38|||Regression, Logistic|||||-0.38|-1.79|0.003
71847861|NCT03928743|143210415|SUPERIORITY||Odds Ratio (OR)|2.47||||0.006|TWO_SIDED|95.0|1.3|4.68|||Regression, Logistic|||||4.68|1.30|0.006
71899060|NCT02433210|143321330|SUPERIORITY||||||=|0.292|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.292
71899061|NCT02433210|143321330|SUPERIORITY||||||=|0.714|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.714
71847862|NCT02224755|143210429|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|9.4|||<|0.001|ONE_SIDED|95.0|-2.1||||Farrington-Manning risk difference||||||-2.1|<0.001
71815867|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.48|||||TWO_SIDED|95.0|0.46|4.73||||||Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels||4.73|0.46|
71815868|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.33|||||TWO_SIDED|95.0|0.11|1.02||||||Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels||1.02|0.11|
71815869|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.16|||||TWO_SIDED|95.0|0.36|3.73||||||Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels||3.73|0.36|
71815870|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.29|2.33||||||Placebo versus Asacol for Week 5 fecal lactoferrin levels||2.33|0.29|
71815871|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.44|||||TWO_SIDED|95.0|0.31|6.59||||||Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels||6.59|0.31|
71847863|NCT02224755|143210430|NON_INFERIORITY|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|19.2|||<|0.001|ONE_SIDED|95.0|9.8||||Farrington-Manning risk difference||||||9.8|<0.001
71847864|NCT02224755|143210431|SUPERIORITY||Risk Ratio (RR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Fisher Exact|||Based on data in the Sponsor's device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher's exact test.||.38|.11|<0.001
71815872|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|2.21|||||TWO_SIDED|95.0|0.54|9.04||||||Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels||9.04|0.54|
71815873|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.41|||||TWO_SIDED|95.0|0.11|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels||1.48|0.11|
71815874|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|1.64|||||TWO_SIDED|95.0|0.46|5.91||||||Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels||5.91|0.46|
71815875|NCT01036022|143133909|SUPERIORITY_OR_OTHER||Ratio|0.84|||||TWO_SIDED|95.0|0.27|2.62||||||Placebo versus Asacol for Week 6 fecal lactoferrin levels||2.62|0.27|
71815876|NCT00576732|143133914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-12.19|-3.52||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|"A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.~A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required."||-3.52|-12.19|<0.001
71815877|NCT00576732|143133914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|2.17||0.164|TWO_SIDED|95.0|-7.36|1.27||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||1.27|-7.36|0.164
71815878|NCT00576732|143133915|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.004
71815879|NCT00576732|143133915|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.817
71815880|NCT00576732|143133916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.02|-0.33||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|||-0.33|-1.02|<0.001
71815881|NCT00576732|143133916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.17||0.769|TWO_SIDED|95.0|-0.39|0.29||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.|||0.29|-0.39|0.769
71815882|NCT00576732|143133917|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||<0.001
71815883|NCT00576732|143133917|SUPERIORITY_OR_OTHER|||||||0.985||95.0||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.||||||0.985
71815884|NCT05096208|143133924|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.858|1.169|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in least-square (LS) means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.169|0.858|
71815885|NCT05096208|143133924|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.9|1.215|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.215|0.900|
71847865|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRP ≥ 1.0 μg/mL||||<0.001
71899062|NCT02433210|143321330|SUPERIORITY||||||=|0.176|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.176
71899063|NCT02433210|143321330|SUPERIORITY||||||=|0.19|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.190
71899064|NCT02433210|143321330|SUPERIORITY|||||||-0.009|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||-0.009
71899065|NCT02433210|143321330|SUPERIORITY||||||=|0.911|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.911
71899066|NCT02433210|143321330|SUPERIORITY||||||=|0.388|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.388
71899067|NCT02433210|143321330|SUPERIORITY||||||=|0.337|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.337
71899068|NCT02433210|143321330|SUPERIORITY||||||=|0.575|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.575
71899069|NCT02433210|143321330|SUPERIORITY||||||=|0.88|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.880
71899070|NCT02433210|143321330|SUPERIORITY||||||=|0.731|||||||t-test, 2 sided|Shapiro-Wilk test for Normality and an equal variance was used. If data failed either, non-parametric Mann-Whitney Rank sum test was used.||||||=0.731
71899071|NCT03046472|143321331|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71899072|NCT03046472|143321332|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71899073|NCT03046472|143321333|OTHER|||||||0.01|||||||t-test, 2 sided|||||||0.01
71899074|NCT01958671|143321340|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||<|0.001|TWO_SIDED|95.0|-1.22|-0.76|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.76|-1.22|<0.001
71899075|NCT01958671|143321340|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.39|-0.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.93|-1.39|<0.001
71899076|NCT01958671|143321341|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-13.1|8.1|||||Based on Miettinen \& Nurminen method.|||8.1|-13.1|
71899077|NCT01958671|143321341|SUPERIORITY_OR_OTHER||Difference in percentage|-4.2|||||TWO_SIDED|95.0|-14.8|6.6|||||Based on Miettinen \& Nurminen method.|||6.6|-14.8|
71899078|NCT01958671|143321342|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-7.7|3.3|||||Based on Miettinen \& Nurminen method.|||3.3|-7.7|
71899079|NCT01958671|143321342|SUPERIORITY_OR_OTHER||Difference in percentage|-2.6|||||TWO_SIDED|95.0|-8.2|2.7|||||Based on Miettinen \& Nurminen method.|||2.7|-8.2|
71899080|NCT01958671|143321343|SUPERIORITY_OR_OTHER||Difference in least squares means|-34.53|||<|0.001|TWO_SIDED|95.0|-42.76|-26.29|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-26.29|-42.76|<0.001
71899081|NCT01958671|143321343|SUPERIORITY_OR_OTHER||Difference in least squares means|-44.01|||<|0.001|TWO_SIDED|95.0|-52.28|-35.74|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-35.74|-52.28|<0.001
71815886|NCT05096208|143133924|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.886|1.232|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV A||1.232|0.886|
71815887|NCT05096208|143133924|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.07|||||TWO_SIDED|95.0|0.905|1.261|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.261|0.905|
71815888|NCT05096208|143133924|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.953|1.336|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.336|0.953|
71847866|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-HBsAg ≥10 mIU/mL||||<0.001
71847867|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Diphtheria ≥0.1 IU/mL||||<0.001
71847868|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Tetanus ≥0.1 IU/mL||||<0.001
71847869|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PT seroresponse||||<0.001
71847870|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FHA seroresponse||||<0.001
71847871|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FIM seroresponse||||<0.001
71847872|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRN seroresponse||||<0.001
71899082|NCT01958671|143321344|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.76|||<|0.001|TWO_SIDED|95.0|-2.57|-0.95|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.95|-2.57|<0.001
71899083|NCT01958671|143321344|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.16|||<|0.001|TWO_SIDED|95.0|-2.98|-1.34|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-1.34|-2.98|<0.001
71899084|NCT01958671|143321345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.59|||<|0.001|TWO_SIDED|95.0|1.85|6.95|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline eGFR.||||6.95|1.85|<0.001
71847873|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV1 ≥1:8 dilution||||<0.001
71847874|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV2 ≥1:8 dilution||||<0.001
71847875|NCT01480258|143210535|OTHER|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV3 ≥1:8 dilution||||<0.001
71847876|NCT01480258|143210536|NON_INFERIORITY|If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06||Stratification by country.|Miettinen & Nurminen|||||51.06|41.05|<0.001
71847877|NCT01480258|143210537|SUPERIORITY|If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|41.05|51.06|||Miettinen & Nurminen|Stratification by country.||||51.06|41.05|<0.001
71847878|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.27|||<|0.001|TWO_SIDED|95.0|-5.13|2.52|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-inferiority for PRP||2.52|-5.13|<0.001
71899085|NCT01958671|143321345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.77|||<|0.001|TWO_SIDED|95.0|3.46|13.24|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline||||13.24|3.46|<0.001
71899086|NCT01958671|143321347|SUPERIORITY_OR_OTHER||Difference in least squares means|-69.03|||<|0.001|TWO_SIDED|95.0|-83.24|-54.83|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-54.83|-83.24|<0.001
71899087|NCT01958671|143321347|SUPERIORITY_OR_OTHER||Difference in least squares means|-67.33|||<|0.001|TWO_SIDED|95.0|-81.73|-52.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-52.93|-81.73|<0.001
71899088|NCT01958671|143321349|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.31||||0.015|TWO_SIDED|95.0|-5.98|-0.65||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.65|-5.98|0.015
71899089|NCT01958671|143321349|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.71||||0.213|TWO_SIDED|95.0|-4.4|0.98|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||0.98|-4.40|0.213
71899090|NCT01958671|143321351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-1.8||||0.039|TWO_SIDED|95.0|-3.51|-0.09||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||-0.09|-3.51|0.039
71899091|NCT01958671|143321351|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.37||||0.669|TWO_SIDED|95.0|-2.09|1.35||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.||||1.35|-2.09|0.669
71678873|NCT03369067|142875742|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678874|NCT03369067|142875742|OTHER|||||||0.111||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.111
71678875|NCT03369067|142875743|OTHER|||||||0.118||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.118
71678876|NCT03369067|142875743|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678877|NCT03369067|142875743|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71899092|NCT02948777|143321352|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71899093|NCT02948777|143321353|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71899094|NCT02948777|143321354|OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71899095|NCT02948777|143321355|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71678878|NCT03369067|142875744|OTHER|||||||0.116||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.116
71678879|NCT03369067|142875744|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71899096|NCT02948777|143321356|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71899097|NCT02948777|143321357|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71899098|NCT02948777|143321358|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71899099|NCT02948777|143321359|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71899100|NCT02948777|143321360|OTHER|||||||0.31|||||||Kruskal-Wallis|||||||0.31
71899101|NCT02948777|143321361|OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71899102|NCT02948777|143321362|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71899103|NCT02948777|143321363|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71899104|NCT02948777|143321364|OTHER|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||||||0.027
71899105|NCT02948777|143321365|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
71899106|NCT02948777|143321366|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
71899107|NCT02948777|143321367|OTHER|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||||||0.81
71899108|NCT02948777|143321368|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71899109|NCT02948777|143321369|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71899110|NCT02948777|143321370|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71899111|NCT02948777|143321371|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71899112|NCT02948777|143321372|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71899113|NCT02948777|143321373|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71899114|NCT02948777|143321375|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
71899115|NCT02948777|143321376|OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71899116|NCT02311478|143321377|OTHER|Given that this is a observational cohort design we do not use either non-inferiority or equivalence analysis. Using ANOVA we test for differences in the number of days per month of bleeding between the 90 days pre-insertion, the 90 days following insertion, and 91-180 days following insertion.|Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|0.28|<|0.05|TWO_SIDED|95.0|1.2|2.3||The p-value is not adjusted for multiple comparisons.|ANOVA|df=2||The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.||2.3|1.2|<0.05
71899117|NCT02311478|143321377|EQUIVALENCE|α of 0.05 or lower.|Mean Difference (Final Values)|0.93|||<|0.05|TWO_SIDED|95.0|0.36|1.5|||t-test, 2 sided|||The estimation parameter compares the 90 days following to the 90 days prior.||1.5|0.36|<0.05
71899118|NCT03242928|143321380|SUPERIORITY||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.037|=|0.021|TWO_SIDED|95.0|-0.161|-0.013|||ANCOVA|||||-0.013|-0.161|= 0.021
71899119|NCT03242928|143321381|SUPERIORITY||Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.077|=|0.025|TWO_SIDED|95.0|-0.331|-0.023|||ANOVA|||||-0.023|-0.331|= 0.025
71899120|NCT03242928|143321382|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.038|=|0.072|TWO_SIDED|95.0|-0.146|0.006|||ANCOVA|||||0.006|-0.146|= 0.072
71815889|NCT05096208|143133924|EQUIVALENCE|Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously.|Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.884|1.262|||||GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model.|RSV B||1.262|0.884|
71815890|NCT01279343|143133944|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.03|TWO_SIDED|95.0|-5.9|-0.3|||t-test, 2 sided|||||-0.3|-5.9|0.03
71847879|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|ifference in percentages|-0.59|||<|0.001|TWO_SIDED|95.0|-2.66|1.35|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for HBsAg||1.35|-2.66|<0.001
71847880|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.21|||<|0.001|TWO_SIDED|95.0|-2.54|-0.22|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Diptheria||-0.22|-2.54|<0.001
71847881|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.95|0.5|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for Tetanus||0.50|-0.95|<0.001
71847882|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.54|||<|0.001|TWO_SIDED|95.0|-1.75|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PT||0.49|-1.75|<0.001
71847883|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.73|||<|0.001|TWO_SIDED|95.0|-3.47|-0.26|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for FHA||-0.26|-3.47|<0.001
71847884|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.42|||<|0.001|TWO_SIDED|95.0|-3.42|0.39|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for PRN||0.39|-3.42|<0.001
71847885|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.51|||<|0.001|TWO_SIDED|95.0|-1.59|0.34|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV1||0.34|-1.59|<0.001
71847886|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|TWO_SIDED|95.0|-0.96|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV2||0.49|-0.96|<0.001
71678880|NCT03369067|142875744|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678881|NCT03369067|142875745|OTHER|||||||0.005||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.005
71678882|NCT03369067|142875745|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71815891|NCT01279343|143133945|SUPERIORITY||Risk Ratio (RR)|0.99||||0.96|TWO_SIDED|95.0|0.8|1.23|||Chi-squared|||Comparison of vaginal delivery between groups.||1.23|.80|0.96
71815892|NCT01279343|143133945|SUPERIORITY||Risk Ratio (RR)|1.03||||0.9|TWO_SIDED|95.0|0.57|1.9|||Chi-squared|||Cesarean deliveries were compared between the groups.||1.90|0.57|0.90
71815893|NCT03245255|143133955|OTHER|Correlation analysis|Pearson Correlation Coefficient|-0.8|STANDARD_DEVIATION|0.1|||TWO_SIDED|||||||||||||
71815894|NCT04765735|143133957|SUPERIORITY||||||<|0.001||||||"It is hypothesized that the proportion of subjects with a reduction in overstimulation sensation during CL compared to OL period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test|||||||<0.001
71899121|NCT00390780|143321384|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025|one-sided test|||"Analyses for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
71678883|NCT03369067|142875745|OTHER|||||||0.193||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.193
71678884|NCT03369067|142875746|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678885|NCT03369067|142875746|OTHER|||||||0.106||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.106
71815895|NCT01022073|143133967|SUPERIORITY_OR_OTHER|||||||0.808|||||||t-test, 2 sided|This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.||||||0.808
71815896|NCT00971750|143133972|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||Chi-squared|||||||0.763
71815897|NCT00971750|143133974|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71815898|NCT01657266|143133975|SUPERIORITY_OR_OTHER|||||||1|||||||Pearson´s Chi-square test|||||||1.00
71815899|NCT00069784|143133999|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.022||||0.6273|TWO_SIDED|95.0|0.937|1.114||For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.||1.114|0.937|0.6273
71815900|NCT00069784|143134000|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.038||||0.2692|TWO_SIDED|95.0|0.972|1.109||The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|See above additional details provided for the analysis of the first coprimary outcome.||1.109|0.972|0.2692
71899122|NCT00390780|143321385|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|one-sided noninferiority test|||"Analysis for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|||-0.15|>0.025
71678886|NCT03369067|142875746|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678887|NCT03369067|142875747|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71815901|NCT00069784|143134001|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.983|||||TWO_SIDED|95.0|0.899|1.076|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.076|0.899|
71815902|NCT00069784|143134002|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97|||||TWO_SIDED|95.0|0.9|1.047|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.|||1.047|0.900|
71815903|NCT00069784|143134003|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.58|0.91|||||Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).|||0.91|0.58|
71815904|NCT01077362|143134066|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815905|NCT01077362|143134066|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815906|NCT01077362|143134066|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815907|NCT01077362|143134067|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
71815908|NCT01077362|143134067|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815909|NCT01077362|143134067|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815910|NCT01077362|143134068|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815911|NCT01077362|143134068|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815912|NCT01077362|143134068|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815913|NCT01077362|143134069|SUPERIORITY_OR_OTHER|||||||0.018|||||||re-randomization test|||||||0.018
71678888|NCT03369067|142875747|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678889|NCT03369067|142875747|OTHER|||||||0.157||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.157
71678890|NCT03369067|142875748|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678891|NCT03369067|142875748|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678892|NCT03369067|142875748|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678893|NCT03369067|142875749|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678894|NCT03369067|142875749|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678895|NCT03369067|142875749|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678896|NCT03369067|142875750|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678897|NCT03369067|142875750|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678898|NCT03369067|142875750|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678899|NCT03369067|142875751|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678900|NCT03369067|142875751|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678901|NCT03369067|142875751|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678902|NCT03369067|142875752|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71815914|NCT01077362|143134069|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815915|NCT01077362|143134069|SUPERIORITY_OR_OTHER|||||||0.002|||||||re-randomization test|||||||0.002
71815916|NCT01077362|143134070|SUPERIORITY_OR_OTHER|||||||0.017|||||||re-randomization test|||||||0.017
71815917|NCT01077362|143134070|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815918|NCT01077362|143134070|SUPERIORITY_OR_OTHER||||||<|0.001|||||||re-randomization test|||||||<0.001
71815919|NCT01077362|143134071|SUPERIORITY_OR_OTHER|||||||0.171|||||||re-randomization|||||||0.171
71815920|NCT01077362|143134071|SUPERIORITY_OR_OTHER|||||||0.06|||||||re-randomization test|||||||0.060
71815921|NCT01077362|143134071|SUPERIORITY_OR_OTHER|||||||0.094|||||||re-randomization|||||||0.094
71815922|NCT01641926|143134077|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|1.6|||||TWO_SIDED|95.0|-8.4|11.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (hepatitis B Virus \[HBV\] genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||11.6|-8.4|
71815923|NCT01641926|143134078|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-3.0|||||TWO_SIDED|95.0|-20.2|14.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||14.3|-20.2|
71815924|NCT01641926|143134079|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.6|||||TWO_SIDED|95.0|-7.2|12.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||12.3|-7.2|
71815925|NCT01641926|143134080|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|2.1|||||TWO_SIDED|95.0|-9.5|13.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||13.6|-9.5|
71815926|NCT01641926|143134080|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|10.1|||||TWO_SIDED|95.0|-7.2|27.1||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||27.1|-7.2|
71815927|NCT01641926|143134081|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.9|||||TWO_SIDED|95.0|-7.4|9.2||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.||9.2|-7.4|
71815928|NCT02294630|143134085|OTHER|||||||0.399|||||||t-test, 2 sided|||||||0.399
71815929|NCT02567825|143134108|SUPERIORITY||Risk Ratio (RR)|0.97||||0.66|TWO_SIDED|95.0|0.84|1.12|||Generalized linear model|The p-value is adjusted for site, age at enrollment, and exposure or nonexposure to other children.|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2-year follow-up period.||1.12|0.84|0.66
71847887|NCT01480258|143210538|NON_INFERIORITY|The estimate of the difference between PR5I \& INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.16|||<|0.001|TWO_SIDED|95.0|-1.2|0.82|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen \& Nurminen method stratified by country.||Non-Inferiority for IPV3||0.82|-1.20|<0.001
71847888|NCT01480258|143210539|NON_INFERIORITY|The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.|Geometric Mean Titre (GMT) ratio|0.8||||0.011|TWO_SIDED|95.0|0.54|1.2|||ANCOVA|||||1.20|0.54|0.011
71847889|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.7|1.4||||||ISR or systemic AE||1.4|-0.7|
71847890|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8||||||95.0|-0.3|2.0||||||ISR or V-related systemic AE||2.0|-0.3|
71847891|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-0.7|6.0||||||At least 1 ISR||6.0|-0.7|
71847892|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.5|||||TWO_SIDED|95.0|-0.9|5.9||||||At least 1 solicited ISR||5.9|-0.9|
71847893|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.1|1.4||||||At least 1 systemic AE||1.4|-1.1|
71847894|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 vaccine-related systemic AE||2.2|-0.5|
71847895|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-0.5|2.2||||||At least 1 solicited systemic AE||2.2|-0.5|
71847896|NCT01480258|143210540|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.9||||||95.0|-0.4|2.3||||||At least 1 vaccine-related solicited systemic AE||2.3|-0.4|
71847897|NCT01480258|143210541|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|8.2|||||TWO_SIDED|95.0|3.0|13.3||||||Injection-site erythema||13.3|3.0|
71847898|NCT01480258|143210541|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.4|||||TWO_SIDED|95.0|-1.5|8.3||||||Injection-site pain||8.3|-1.5|
71899123|NCT00390780|143321386|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.0974|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.0974
71678903|NCT03369067|142875752|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with age group as a fixed factor. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678904|NCT03369067|142875752|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using Wilcoxon signed-rank test with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|Wilcoxon (Mann-Whitney)|||||||>0.2
71678905|NCT03369067|142875753|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678906|NCT03369067|142875753|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678907|NCT03369067|142875753|OTHER|||||||0.073||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.073
71678908|NCT03369067|142875754|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678909|NCT03369067|142875754|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678910|NCT03369067|142875754|OTHER|||||||0.064||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.064
71678911|NCT03369067|142875755|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71815930|NCT02567825|143134109|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.67|1.01|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at low risk of AOM recurrences at enrollment..||1.01|0.67|
71815931|NCT02567825|143134109|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|Null hypothesis: There is no difference between the two groups in the rate of occurrence of AOM per child-year during the 2 year follow-up among children considered at high risk of AOM recurrences at enrollment.||1.33|0.86|
71815932|NCT02567825|143134109|OTHER|||||||0.08|||||||Generalized linear models|||Null hypothesis: There is no interaction between comparison group (Surgical Management, Non-Surgical Management) and risk group (children considered at low risk of AOM recurrences at enrollment, children considered at high risk of AOM recurrences at enrollment).||||0.08
71678912|NCT03369067|142875755|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678913|NCT03369067|142875755|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678914|NCT03369067|142875756|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678915|NCT03369067|142875756|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678916|NCT03369067|142875756|OTHER|||||||0.104||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.104
71678917|NCT03369067|142875757|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678918|NCT03369067|142875757|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678919|NCT03369067|142875757|OTHER|||||||0.198||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||0.198
71678920|NCT03369067|142875758|OTHER|||||||0.105||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.105
71678921|NCT03369067|142875758|OTHER|||||||0.001||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||0.001
71815933|NCT02567825|143134110|SUPERIORITY|||||||0.48|||||||Chi-squared|||"Null hypothesis: There is no difference between the two groups in the proportion of children completing the study with 0, 1 or 2, 3 or 4, greater than or equal to 5 episodes of AOM.~."||||0.48
71815934|NCT02567825|143134111|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.58|0.92|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children experiencing treatment failure.||0.92|0.58|
71815935|NCT02567825|143134112|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.52|0.9|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the time to the first episode of AOM.||0.90|0.52|
71899124|NCT00390780|143321386|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|Compare proportion of clinical success|0.15||||0.1115|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.1115
71899125|NCT00390780|143321387|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.8787|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.8787
71899126|NCT00390780|143321387|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.7969|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|||-0.15|0.7969
71899127|NCT00390780|143321388|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.882|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.8820
71899128|NCT00390780|143321388|NON_INFERIORITY_OR_EQUIVALENCE|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.9033|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|||-0.15|0.9033
71899129|NCT00390780|143321389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion mycologic cure|0.15||||0.5816|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.5816
71899130|NCT00390780|143321389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population|difference in proportion mycologic cure|0.15||||0.4439|ONE_SIDED|95.0|-0.15|||Significance level was \<0.025.|Chi-squared||||||-0.15|0.4439
71899131|NCT00390780|143321390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for ITT population.|difference in proportion relapsed|0.15||||0.833|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.8330
71899132|NCT00390780|143321390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority statistical analysis for PP population.|difference in proportion relapsed|0.15||||0.9738|ONE_SIDED|95.0|-0.15|||Significance level is \<0.025.|Chi-squared||||||-0.15|0.9738
71899133|NCT00390780|143321395|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups||||0.1860
71899134|NCT00390780|143321395|SUPERIORITY_OR_OTHER|||||||0.9564||95.0|||||Wilcoxon (Mann-Whitney)|||Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups||||0.9564
71678922|NCT03369067|142875758|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678923|NCT03369067|142875759|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71899135|NCT00109733|143321397|SUPERIORITY_OR_OTHER|||||||0.177|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.177
71678924|NCT03369067|142875759|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with age group as a fixed factor. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71678925|NCT03369067|142875759|OTHER||||||>|0.2||||||Primary statistical analysis between treatment groups was performed using univariate ANOVA with the treatment mode and age group as fixed factors. P value \<0.05 was considered significant.|ANOVA|||||||>0.2
71899136|NCT00109733|143321397|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
71899137|NCT00109733|143321398|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.004
71899138|NCT00109733|143321398|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
71815936|NCT02567825|143134113|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes categorized as probably severe.||1.09|0.76|
71815937|NCT02567825|143134114|SUPERIORITY||Risk Ratio (RR)|0.34|||||TWO_SIDED|95.0|0.26|0.44||||||Null hypothesis: There is no difference between the two groups in the proportion of episodes presenting with tympanic membrane bulging rather than otorrhea|The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|0.44|0.26|
71815938|NCT02567825|143134115|SUPERIORITY||Difference of least-squares means|5.21|||||TWO_SIDED|95.0|2.6|7.82|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience tube otorrhea. The analysis uses a weighted regression model with weights equal to the length of follow-up.||7.82|2.60|
71815939|NCT02567825|143134116|SUPERIORITY||Difference of least-squares means|-6.32|||||TWO_SIDED|95.0|-7.55|-5.1|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children experience AOM symptoms with an intact TM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-5.10|-7.55|
71815940|NCT02567825|143134117|SUPERIORITY||Difference of least-squares means|-4.5|||||TWO_SIDED|95.0|-6.82|-2.18|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean days per year children receive systemic antimicrobials for AOM. The analysis uses a weighted regression model with weights equal to the length of follow-up.||-2.18|-6.82|
71815941|NCT02567825|143134118|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||The Surgical Management group represents the numerator for the hazard ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom PDD was reported.||1.03|0.44|
71815942|NCT02567825|143134119|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.51|1.22|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom diaper dermatitis was reported.||1.22|0.51|
71815943|NCT02567825|143134120|SUPERIORITY||Risk Ratio (RR)|2.57|||||TWO_SIDED|95.0|1.91|3.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups regarding the proportion of children for whom tube otorrhea was reported.||3.48|1.91|
71815944|NCT02567825|143134121|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children with no pathogens at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.24|0.74|
71847899|NCT01480258|143210541|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|7.5||||||95.0|2.1|12.9||||||Injection-site swelling||12.9|2.1|
71815945|NCT02567825|143134121|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.83|1.72|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive only for at least 1 penicillin-susceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.72|0.83|
71815946|NCT02567825|143134121|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.94|1.29|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of children positive for at least 1 penicillin nonsusceptible pathogen at enrollment having a penicillin-nonsusceptible nasopharyngeal or throat isolate at some follow-up visit.||1.29|0.94|
71815947|NCT02567825|143134122|SUPERIORITY||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.84|1.55|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of episodes of AOM at which a nonsusceptible pathogen is recovered.||1.55|0.84|
71815948|NCT02567825|143134123|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.84|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of routine non-illness visits at which a nonsusceptible pathogen is recovered.||1.41|0.84|
71678926|NCT00459706|142875776|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95 percent (%) two-sided confidence interval (CI) of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.11|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.71|1.5|||ANOVA|ANOVA=analysis of variance||Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (\>) -1.||1.50|0.71|<0.001
71815949|NCT02567825|143134124|SUPERIORITY|The analysis was ITT. The participants are randomized children with at least one episode of AOM late during the respiratory season at which a nasopharyngeal or throat culture is obtained.|Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.69|1.95|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator.|||1.95|0.69|
71847900|NCT01480258|143210542|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|-1.1|||||TWO_SIDED|95.0|-2.5|0.3||||||Injection-site bruising||0.3|-2.5|
71847901|NCT01480258|143210542|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.5|1.6||||||Injection-site haemorrhage||1.6|-1.5|
71847902|NCT01480258|143210542|OTHER||Risk Difference (RD)|2.6|||||TWO_SIDED|95.0|-1.2|6.4||||||Injection-site induration||6.4|-1.2|
71847903|NCT01480258|143210542|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||TWO_SIDED|95.0|-0.8|1.5||||||Injection-site nodule||1.5|-0.8|
71847904|NCT01480258|143210542|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|1.1||||||95.0|-0.4|2.7||||||Injection-site warmth||2.7|-0.4|
71847905|NCT01480258|143210543|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.3|5.7||||||Crying||5.7|-1.3|
71847906|NCT01480258|143210543|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.6|||||TWO_SIDED|95.0|-1.6|8.8||||||Decreased appetite||8.8|-1.6|
71847907|NCT01480258|143210543|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-1.0|5.4||||||Irritability||5.4|-1.0|
71847908|NCT01480258|143210543|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|6.4|||||TWO_SIDED|95.0|1.5|11.3||||||Pyrexia||11.3|1.5|
71847909|NCT01480258|143210543|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|5.8|||||TWO_SIDED|95.0|1.7|9.8||||||Somnolence||9.8|1.7|
71847910|NCT01480258|143210543|OTHER|The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.9||||||Vomiting||6.9|-3.2|
71847911|NCT01482091|143210544|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
71678927|NCT00459706|142875777|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority test was performed using the 95% two-sided CI of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI \> -1."|Mean Difference (Net)|1.25|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|0.85|1.64|||ANOVA|||"Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI - PFS ≤ -1 H1: AI - PFS \> -1"||1.64|0.85|<0.001
71678928|NCT00459706|142875778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.058|TWO_SIDED|95.0|0.98|3.05|||GEE Model+Logit Link+Binomial Distributn|GEE=Generalized estimating equation Distribn=distribution||||3.05|0.98|0.058
71678929|NCT00459706|142875779|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96||||0.019|TWO_SIDED|95.0|1.12|3.43|||GEE Model+Logit Link+Binomial Distributn|||||3.43|1.12|0.019
71678930|NCT00459706|142875780|SUPERIORITY_OR_OTHER||Regression coefficient|0.11||||0.16|TWO_SIDED|95.0|-0.04|0.27|||Regression, Linear|||All categories||0.27|-0.04|0.160
71815950|NCT02567825|143134125|SUPERIORITY||Difference of least-squares means|0.25|||||TWO_SIDED|95.0|-0.06|0.56|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean parental satisfaction score||0.56|-0.06|
71678931|NCT00459706|142875781|SUPERIORITY_OR_OTHER||Regression coefficients|-0.75||||0.001|TWO_SIDED|95.0|-1.2|-0.29|||Regression, Linear|||Female versus male (reference).||-0.29|-1.20|0.001
71815951|NCT02567825|143134126|SUPERIORITY||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.98|1.18|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating at least one health care encounter since the previous study visit.||1.18|0.98|
71815952|NCT02567825|143134127|SUPERIORITY|Reports for which the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.88|1.41|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating a parent missed work due to child's illness.||1.41|0.88|
71815953|NCT02567825|143134128|SUPERIORITY|Reports indicating the parent did not answer the question were excluded from the analysis.|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.89|1.48|||||The Surgical Management group represents the numerator for the risk ratio and the Non-Surgical Management group represents the denominator. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the proportion of parent reports indicating the need for special childcare arrangements due to child's illness.||1.48|0.89|
71815954|NCT02567825|143134129|SUPERIORITY||Difference of least-square means|-0.05|||||TWO_SIDED|95.0|-0.13|0.02|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey score||0.02|-0.13|
71815955|NCT02567825|143134129|SUPERIORITY||Difference of least-square means|0.06|||||TWO_SIDED|95.0|-0.13|0.24|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean OM-6 survey--children's overall QOL score.||0.24|-0.13|
71815956|NCT02567825|143134130|SUPERIORITY||Difference of least-square means|-0.04|||||TWO_SIDED|95.0|-1.55|1.47|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire score.||1.47|-1.55|
71847912|NCT01482091|143210546|SUPERIORITY_OR_OTHER||||||=|0.05|||||||Fisher Exact|||||||=0.05
71847913|NCT01482091|143210547|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71847914|NCT01482091|143210550|SUPERIORITY_OR_OTHER||||||=|0.68|||||||t-test, 2 sided|||||||=0.68
71847915|NCT01482091|143210551|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71847916|NCT01482091|143210552|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71847917|NCT01482091|143210556|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71847918|NCT03316170|143210559|SUPERIORITY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.44||0.06|TWO_SIDED|95.0|-1.75|0.3|||t-test, 2 sided|||||0.30|-1.75|.06
71847919|NCT03775915|143210575|OTHER||||||>|0.05||||||p-value calculated for interaction between group and day|Linear Mixed Model|Linear mixed effects model adjusted for baseline, F(2,46) = 1.061, p \>0.05||||||>0.05
71847920|NCT03775915|143210576|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71847921|NCT00910962|143210609|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.411|TWO_SIDED|95.0|0.46|1.38|||Cox' proportional hazards model|||||1.38|0.46|0.4110
71847922|NCT00910962|143210609|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.9318|TWO_SIDED|95.0|0.6|1.74|||Cox' proportional hazards model|||||1.74|0.60|0.9318
71847923|NCT00910962|143210609|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6805|TWO_SIDED|95.0|0.56|1.46|||Cox' proportional hazards model|||||1.46|0.56|0.6805
71847924|NCT00910962|143210610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.299|TWO_SIDED|95.0|0.39|1.34|||Cox' proportional hazards model|||||1.34|0.39|0.2990
71847925|NCT00910962|143210610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.8235|TWO_SIDED|95.0|0.6|1.9|||Cox' proportional hazards model|||||1.90|0.60|0.8235
71847926|NCT00910962|143210610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.659|TWO_SIDED|95.0|0.52|1.51|||Cox' proportional hazards model|||||1.51|0.52|0.6590
71847927|NCT00910962|143210616|SUPERIORITY||test to reference ratio|0.8||||0.151|TWO_SIDED|95.0|0.59|1.09|||Repeated measures ANCOVA|||||1.09|0.59|0.151
71847928|NCT00910962|143210616|SUPERIORITY||test to reference ratio|0.95||||0.744|TWO_SIDED|95.0|0.7|1.29|||Repeated measures ANCOVA|||||1.29|0.70|0.744
71678932|NCT00459706|142875782|SUPERIORITY_OR_OTHER||Regression coefficient|-0.18||||0.676|TWO_SIDED|95.0|-0.62|0.26|||Regression, Linear|||Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).||0.26|-0.62|0.676
71678933|NCT00459706|142875782|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.676|TWO_SIDED|95.0|-0.59|0.6|||Regression, Linear|||Participants at University Level versus participants with only Reading/Writing Capacity (reference).||0.60|-0.59|0.676
71847929|NCT00910962|143210616|SUPERIORITY||test to treatment ratio|0.87||||0.317|TWO_SIDED|95.0|0.66|1.14|||Repeated measures ANCOVA|||||1.14|0.66|0.317
71847930|NCT00910962|143210617|SUPERIORITY||test to reference ratio|1.03||||0.83|TWO_SIDED|95.0|0.8|1.32|||ANCOVA|||||1.32|0.80|0.83
71847931|NCT00910962|143210617|SUPERIORITY||test to reference ratio|1.08||||0.56|TWO_SIDED|95.0|0.84|1.39|||ANCOVA|||||1.39|0.84|0.56
71847932|NCT00910962|143210617|SUPERIORITY||test to reference ratio|1.05||||0.65|TWO_SIDED|95.0|0.84|1.32|||ANCOVA|||||1.32|0.84|0.65
71847933|NCT00910962|143210618|SUPERIORITY||Test to reference ratio|0.77||||0.04|TWO_SIDED|95.0|0.6|0.99|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.99|0.60|0.040
71847934|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.66||||0.001|TWO_SIDED|95.0|0.52|0.85|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.85|0.52|0.001
71847935|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.71||||0.003|TWO_SIDED|95.0|0.57|0.89|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.89|0.57|0.003
71847936|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.78|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 48 hours||0.78|0.40|<0.001
71847937|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.33|0.65|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 48 hours||0.65|0.33|<0.001
71847938|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.51|||<|0.001|TWO_SIDED|95.0|0.38|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 48 hours||0.69|0.38|<0.001
71847939|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.68||||0.059|TWO_SIDED|95.0|0.45|1.01|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.01|0.45|0.059
71847940|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||0.90|0.40|0.013
71847941|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.64||||0.015|TWO_SIDED|95.0|0.45|0.92|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||0.92|0.45|0.015
71847942|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.7||||0.073|TWO_SIDED|95.0|0.48|1.03|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||1.03|0.48|0.073
71847943|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.7||||0.075|TWO_SIDED|95.0|0.48|1.04|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.04|0.48|0.075
71847944|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.7||||0.044|TWO_SIDED|95.0|0.5|0.99|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||0.99|0.50|0.044
71847945|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.78||||0.157|TWO_SIDED|95.0|0.55|1.1|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 4||1.10|0.55|0.157
71847946|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.9||||0.548|TWO_SIDED|95.0|0.63|1.28|||ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 4||1.28|0.63|0.548
71847947|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.83||||0.253|TWO_SIDED|95.0|0.61|1.14|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 4||1.14|0.61|0.253
71847948|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.8||||0.204|TWO_SIDED|95.0|0.58|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 8||1.13|0.58|0.204
71847949|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.99||||0.965|TWO_SIDED|95.0|0.71|1.39|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 8||1.39|0.71|0.965
71847950|NCT00910962|143210618|SUPERIORITY||test to reference ratio|0.89||||0.457|TWO_SIDED|95.0|0.66|1.2|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 8||1.20|0.66|0.457
71847951|NCT00910962|143210618|SUPERIORITY||test to reference ratio|1.58||||0.008|TWO_SIDED|95.0|1.13|2.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 14||2.22|1.13|0.008
71847952|NCT00910962|143210618|SUPERIORITY||test to reference ratio|1.69||||0.002|TWO_SIDED|95.0|1.21|2.38|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 14||2.38|1.21|0.002
71847953|NCT00910962|143210618|SUPERIORITY||test to reference ratio|1.64||||0.001|TWO_SIDED|95.0|1.21|2.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 14||2.21|1.21|0.001
71678934|NCT00459706|142875783|SUPERIORITY_OR_OTHER||Regression coefficient|-0.28||||0.02|TWO_SIDED|95.0|-0.52|-0.05|||Regression, Linear|||All categories||-0.05|-0.52|0.020
71847954|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.43|0.69|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours||0.69|0.43|<0.001
71847955|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.64|||<|0.001|TWO_SIDED|95.0|0.5|0.82|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours||0.82|0.50|<0.001
71847956|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.48|0.73|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours||0.73|0.48|<0.001
71847957|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.76||||0.031|TWO_SIDED|95.0|0.59|0.98|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2||0.98|0.59|0.031
71847958|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.88||||0.315|TWO_SIDED|95.0|0.68|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2||1.13|0.68|0.315
71847959|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.82||||0.075|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2||1.02|0.65|0.075
71847960|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.81||||0.068|TWO_SIDED|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||1.02|0.65|0.068
71678935|NCT00459706|142875784|SUPERIORITY_OR_OTHER||Regression coefficient|-0.35||||0.008|TWO_SIDED|95.0|-0.61|-0.09|||Regression, Linear|||All categories||-0.09|-0.61|0.008
71678936|NCT00459706|142875785|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.03|TWO_SIDED|95.0|0.02|0.32|||Regression, Linear|||All categories||0.32|0.02|0.030
71815957|NCT02567825|143134130|SUPERIORITY||Difference of least-square means|0.03|||||TWO_SIDED|95.0|-0.14|0.2|||||The Surgical Management group represents the first number in the subtraction and the Non-Surgical Management group represents the second. The estimates are adjusted for site, age at enrollment, and exposure or nonexposure to other children.|Null hypothesis: There is no difference between the two groups in the mean caregiver impact questionnaire--caregiver's overall QOL score.||0.20|-0.14|
71815958|NCT03107377|143134177|SUPERIORITY||Risk Difference (RD)|-4.81||||0.0256|TWO_SIDED|95.0|-9.02|-0.61|||Chi-squared|||||-0.61|-9.02|0.0256
71815959|NCT03107377|143134178|SUPERIORITY||Risk Difference (RD)|-2.53||||0.0316|TWO_SIDED|95.0|-4.84|-0.23|||Chi-squared|||||-0.23|-4.84|0.0316
71815960|NCT03107377|143134182|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
71815961|NCT03107377|143134182|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||1.0000
71815962|NCT03107377|143134182|SUPERIORITY|||||||0.6278|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||.6278
71815963|NCT03107377|143134182|SUPERIORITY|||||||0.6404|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=40% adherence||||.6404
71815964|NCT03107377|143134182|SUPERIORITY|||||||0.5008|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||.5008
71815965|NCT03107377|143134182|SUPERIORITY|||||||0.1818|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||.1818
71815966|NCT03107377|143134182|SUPERIORITY|||||||0.0012|||||||Chi-squared|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||0.0012
71815967|NCT03107377|143134183|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =0% adherence||||1.0000
71847961|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.97||||0.824|TWO_SIDED|95.0|0.78|1.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.22|0.78|0.824
71847962|NCT00910962|143210619|SUPERIORITY||test to reference ratio|0.89||||0.246|TWO_SIDED|95.0|0.73|1.09|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||1.09|0.73|0.246
71847963|NCT00910962|143210620|SUPERIORITY||test to reference ratio|1.04||||0.66|TWO_SIDED|95.0|0.89|1.21|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours||1.21|0.89|0.66
71847964|NCT00910962|143210620|SUPERIORITY||test to reference ratio|1.07||||0.39|TWO_SIDED|95.0|0.92|1.25|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours||1.25|0.92|0.39
71847965|NCT00910962|143210620|SUPERIORITY||test to reference ratio|1.05||||0.47|TWO_SIDED|95.0|0.92|1.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours||1.21|0.92|0.47
71847966|NCT00910962|143210621|SUPERIORITY||test to reference ratio|0.99||||0.92|TWO_SIDED|95.0|0.78|1.25|||Repeated measures ANCOVA|||||1.25|0.78|0.92
71847967|NCT00910962|143210621|SUPERIORITY||test to reference ratio|1.08||||0.52|TWO_SIDED|95.0|0.85|1.36|||Repeated measures ANCOVA|||||1.36|0.85|0.52
71847968|NCT00910962|143210621|SUPERIORITY||test to reference ratio|1.03||||0.76|TWO_SIDED|95.0|0.84|1.27|||Repeated measures ANCOVA|||||1.27|0.84|0.76
71847969|NCT00910962|143210622|SUPERIORITY||test to reference ratio|0.93||||0.57|TWO_SIDED|95.0|0.72|1.2|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For discharge/early withdrawal||1.20|0.72|0.57
71815968|NCT03107377|143134183|SUPERIORITY|||||||0.4375|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>0% adherence||||0.4375
71815969|NCT03107377|143134183|SUPERIORITY|||||||0.4444|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=20% adherence||||0.4444
71899139|NCT00109733|143321399|SUPERIORITY_OR_OTHER|||||||0.653|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.653
71815970|NCT03107377|143134183|SUPERIORITY|||||||0.1836|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=60% adherence||||0.1836
71815971|NCT03107377|143134183|SUPERIORITY|||||||0.5006|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with \>=80% adherence||||0.5006
71815972|NCT03107377|143134183|SUPERIORITY|||||||1|||||||Fisher Exact|||A comparison of infection rates between the treatment arms amongst subjects with =100% adherence||||1.000
71815973|NCT01121172|143134223|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Non parametric test||||||0.001
71815974|NCT01121172|143134224|SUPERIORITY_OR_OTHER|||||||0.232|||||||Chi-squared|Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution||||||0.232
71815975|NCT02100722|143134237|NON_INFERIORITY|Noninferiority of FFR-guided PCI to CABG was prespecified as an upper boundary of less than 1.65 for the 95% confidence interval of the hazard ratio.|Hazard Ratio (HR)|1.5||||0.35|TWO_SIDED|95.0|1.1|2.2|||Regression, Cox|||A sample of 712 patients per group (1424 for the entire trial) would be required in order to achieve 90% power to claim noninferiority||2.2|1.1|0.35
71815976|NCT02100722|143134240|OTHER||Hazard Ratio (HR)|1.7|||||TWO_SIDED|95.0|0.7|4.3||||||||4.3|0.7|
71847970|NCT00910962|143210622|SUPERIORITY||test to reference ratio|0.92||||0.52|TWO_SIDED|95.0|0.72|1.18|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For discharge/early withdrawal||1.18|0.72|0.52
71847971|NCT00910962|143210622|SUPERIORITY||test to reference ratio|0.92||||0.5|TWO_SIDED|95.0|0.74|1.16|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For discharge/early withdrawal||1.16|0.74|0.50
71678937|NCT00459706|142875786|SUPERIORITY_OR_OTHER||Regression coefficient|-0.6||||0.006|TWO_SIDED|95.0|-1.03|-0.18|||Regression, Linear|||Self-injection Experience versus No Self-injection Experience (reference).||-0.18|-1.03|0.006
71815977|NCT02100722|143134241|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.5|||||Hazard ratio for overall number of participants experiencing MI.|||2.5|0.9|
71815978|NCT02100722|143134242|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.4||||||||2.4|0.3|
71815979|NCT02100722|143134243|OTHER||Hazard Ratio (HR)|1.5|||||TWO_SIDED|95.0|0.9|2.3|||||Hazard ratio for overall number of participants experiencing repeat revascularization.|||2.3|0.9|
71815980|NCT02100722|143134244|OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
71815981|NCT02100722|143134245|OTHER||||||<|0.04|||||||Fisher Exact|||||||<0.04
71815982|NCT02100722|143134246|OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71815983|NCT02100722|143134249|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71847972|NCT00910962|143210622|SUPERIORITY||test to reference ratio|0.73||||0.03|TWO_SIDED|95.0|0.55|0.96|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.96|0.55|0.03
71847973|NCT00910962|143210622|SUPERIORITY||test to reference ratio|0.81||||0.14|TWO_SIDED|95.0|0.61|1.07|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||1.07|0.61|0.14
71847974|NCT00910962|143210622|SUPERIORITY||test to reference ratio|0.76||||0.04|TWO_SIDED|95.0|0.6|0.98|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.98|0.60|0.04
71678938|NCT00459706|142875787|SUPERIORITY_OR_OTHER||Regression coefficient|0.06||||0.278|TWO_SIDED|95.0|-0.05|0.18|||Regression, Linear|||All categories||0.18|-0.05|0.278
71678939|NCT00459706|142875788|SUPERIORITY_OR_OTHER||Regression coefficient|0.03||||0.749|TWO_SIDED|95.0|-0.15|0.21|||Regression, Linear|||All categories||0.21|-0.15|0.749
71678940|NCT00459706|142875789|SUPERIORITY_OR_OTHER||Regression coefficient|-0.08||||0.105|TWO_SIDED|95.0|-0.18|0.02|||Regression, Linear|||All categories||0.02|-0.18|0.105
71815984|NCT02541383|143134336|SUPERIORITY||Odds Ratio (OR)|1.6||||0.001|TWO_SIDED|95.0|1.21|2.12|||Cochran-Mantel-Haenszel|||||2.12|1.21|0.0010
71815985|NCT02541383|143134337|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Log Rank|||||0.68|0.42|<0.0001
71815986|NCT02541383|143134338|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.52|0.72|||Log Rank|||||0.72|0.52|<0.0001
71815987|NCT02583763|143134339|SUPERIORITY||||||>|0.05||||||Significance value stated as p\<0.05|t-test, 2 sided|||Paired sample T test were used to analyse normally distributed data.||||>0.05
71815988|NCT02583763|143134340|SUPERIORITY||||||>|0.05||||||Significance value was stated as p\<0.05|t-test, 2 sided|||||||>0.05
71815989|NCT02583763|143134341|SUPERIORITY|||||||0.003||||||Significance value was set to p\<0.05|t-test, 2 sided|||||||0.003
71815990|NCT03500640|143134347|SUPERIORITY|||||||0.196||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.196
71815991|NCT03500640|143134348|SUPERIORITY|||||||0.8||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.800
71815992|NCT03500640|143134349|SUPERIORITY|||||||0.677|||||||t-test, 2 sided|||||||0.677
71815993|NCT03500640|143134350|SUPERIORITY|||||||0.349||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.349
71815994|NCT03500640|143134351|SUPERIORITY|||||||0.891|||||||t-test, 2 sided|||||||0.891
71678941|NCT00459706|142875790|SUPERIORITY_OR_OTHER||Regression coefficient|0.01||||0.819|TWO_SIDED|95.0|-0.1|0.12|||Regression, Linear|||All categories||0.12|-0.10|0.819
71678942|NCT00459706|142875791|SUPERIORITY_OR_OTHER||Regression coefficient|-0.39||||0.012|TWO_SIDED|95.0|-0.69|-0.09|||Regression, Linear|||All categories, by 1-unit increments.||-0.09|-0.69|0.012
71815995|NCT03500640|143134352|SUPERIORITY|||||||0.14||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.140
71815996|NCT03500640|143134353|SUPERIORITY|||||||0.732|||||||t-test, 2 sided|||||||0.732
71815997|NCT03500640|143134354|SUPERIORITY|||||||0.637||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.637
71815998|NCT03500640|143134355|SUPERIORITY|||||||0.521||||||The a priori threshold for statistical significance was p = 0.05|t-test, 2 sided|||||||0.521
71815999|NCT03500640|143134356|SUPERIORITY|||||||0.083||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.083
71816000|NCT03500640|143134357|SUPERIORITY|||||||0.778||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.778
71816001|NCT03500640|143134358|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.982
71816002|NCT03500640|143134359|SUPERIORITY|||||||0.081||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.081
71816003|NCT03500640|143134360|SUPERIORITY|||||||0.712||||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.712
71816004|NCT03500640|143134361|SUPERIORITY|||||||0.371||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.371
71816005|NCT03500640|143134362|SUPERIORITY|||||||0.801||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.801
71816006|NCT03500640|143134363|SUPERIORITY|||||||0.069||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.069
71816007|NCT03500640|143134364|SUPERIORITY|||||||0.193||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.193
71816008|NCT03500640|143134365|SUPERIORITY|||||||0.197||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.197
71816009|NCT03500640|143134366|SUPERIORITY|||||||0.594||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.594
71816010|NCT03500640|143134367|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||||||0.328
71816011|NCT03500640|143134368|SUPERIORITY|||||||0.398||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.398
71847975|NCT00910962|143210623|SUPERIORITY||Mean Difference (Final Values)|-1.92||||0.254|TWO_SIDED|95.0|-5.25|1.41|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Day 3-5 (visit 1)||1.41|-5.25|0.254
71816012|NCT03500640|143134369|SUPERIORITY|||||||0.288||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.288
71847976|NCT00910962|143210623|SUPERIORITY||Mean Difference (Final Values)|-2.84||||0.106|TWO_SIDED|95.0|-6.29|0.62|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Day 3-5 (visit 1)||0.62|-6.29|0.106
71678943|NCT00459706|142875792|SUPERIORITY_OR_OTHER||Regression coefficient|-0.1||||0.541|TWO_SIDED|95.0|-0.52|0.32|||Regression, Linear|||2 DMARDs versus 1 DMARD (reference).||0.32|-0.52|0.541
71678944|NCT00459706|142875792|SUPERIORITY_OR_OTHER||Regression coefficient|-0.14||||0.541|TWO_SIDED|95.0|-0.97|0.68|||Regression, Linear|||3 DMARDs versus 1 DMARD (reference).||0.68|-0.97|0.541
71847977|NCT00910962|143210623|SUPERIORITY||Mean Difference (Final Values)|-2.38||||0.126|TWO_SIDED|95.0|-5.44|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Day 3-5 (visit 1)||0.69|-5.44|0.126
71847978|NCT00910962|143210623|SUPERIORITY||Mean Difference (Final Values)|-1.91||||0.184|TWO_SIDED|95.0|-4.74|0.92|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12||0.92|-4.74|0.184
71847979|NCT00910962|143210623|SUPERIORITY||Mean Difference (Final Values)|-2.47||||0.093|TWO_SIDED|95.0|-5.37|0.43|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12||0.43|-5.37|0.093
71847980|NCT00910962|143210623|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.096|TWO_SIDED|95.0|-4.78|0.4|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12||0.40|-4.78|0.096
71847981|NCT00910962|143210624|SUPERIORITY||Mean Difference (Final Values)|4.22||||0.124|TWO_SIDED|95.0|-1.18|9.62|||Repeated measures ANCOVA|||||9.62|-1.18|0.124
71847982|NCT00910962|143210624|SUPERIORITY||Mean Difference (Final Values)|6.05||||0.029|TWO_SIDED|95.0|0.63|11.47|||Repeated measures ANCOVA|||||11.47|0.63|0.029
71847983|NCT00910962|143210624|SUPERIORITY||Mean Difference (Final Values)|5.14||||0.039|TWO_SIDED|95.0|0.28|10.0|||Repeated measures ANCOVA|||||10.00|0.28|0.039
71847984|NCT00910962|143210625|SUPERIORITY||Mean Difference (Final Values)|-21.53||||0.025|TWO_SIDED|95.0|-40.27|-2.79|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVEDV||-2.79|-40.27|0.025
71899140|NCT00109733|143321399|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.002
71899141|NCT00109733|143321400|SUPERIORITY_OR_OTHER|||||||0.755|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.755
71847985|NCT00910962|143210625|SUPERIORITY||Mean Difference (Final Values)|-18.65||||0.053|TWO_SIDED|95.0|-37.58|0.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVEDV||0.29|-37.58|0.053
71847986|NCT00910962|143210625|SUPERIORITY||Mean Difference (Final Values)|-20.09||||0.021|TWO_SIDED|95.0|-37.01|-3.18|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVEDV||-3.18|-37.01|0.021
71847987|NCT00910962|143210625|SUPERIORITY||Mean Difference (Final Values)|-15.82||||0.024|TWO_SIDED|95.0|-29.51|-2.14|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVESV||-2.14|-29.51|0.024
71678945|NCT00459706|142875792|SUPERIORITY_OR_OTHER||Regression coefficient|1.72||||0.541|TWO_SIDED|95.0|-0.82|4.25|||Regression, Linear|||At least 4 DMARDs versus 1 DMARD (reference).||4.25|-0.82|0.541
71816013|NCT03500640|143134370|SUPERIORITY|||||||0.592||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.592
71847988|NCT00910962|143210625|SUPERIORITY||Mean Difference (Final Values)|-17.22||||0.016|TWO_SIDED|95.0|-31.14|-3.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVESV||-3.29|-31.14|0.016
71847989|NCT00910962|143210625|SUPERIORITY||Mean Difference (Final Values)|-16.52||||0.01|TWO_SIDED|95.0|-28.91|-4.13|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVESV||-4.13|-28.91|0.010
71847990|NCT00910962|143210626|SUPERIORITY||Mean Difference (Final Values)|-22.21||||0.109|TWO_SIDED|95.0|-49.51|5.09|||Repeated measures ANCOVA|||||5.09|-49.51|0.109
71847991|NCT00910962|143210626|SUPERIORITY||Mean Difference (Final Values)|-7.13||||0.614|TWO_SIDED|95.0|-35.22|20.96|||Repeated measures ANCOVA|||||20.96|-35.22|0.614
71816014|NCT03500640|143134371|SUPERIORITY|||||||0.805||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.805
71816015|NCT03500640|143134372|SUPERIORITY|||||||0.421||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||The p value provided here is for the physical component summary score (PCS) only||||0.421
71847992|NCT00910962|143210626|SUPERIORITY||Mean Difference (Final Values)|-14.67||||0.243|TWO_SIDED|95.0|-39.52|10.18|||Repeated measures ANCOVA|||||10.18|-39.52|0.243
71847993|NCT00910962|143210627|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.023|TWO_SIDED|95.0|-0.44|-0.03|||Repeated measures ANCOVA|||||-0.03|-0.44|0.023
71847994|NCT00910962|143210627|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.021|TWO_SIDED|95.0|-0.45|-0.04|||Repeated measures ANCOVA|||||-0.04|-0.45|0.021
71847995|NCT00910962|143210627|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.011|TWO_SIDED|95.0|-0.42|-0.06|||Repeated measures ANCOVA|||||-0.06|-0.42|0.011
71847996|NCT00910962|143210628|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.137|TWO_SIDED|95.0|-0.26|0.04|||Repeated measures ANCOVA|||||0.04|-0.26|0.137
71847997|NCT00910962|143210628|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.036|TWO_SIDED|95.0|-0.32|-0.01|||Repeated measures ANCOVA|||||-0.01|-0.32|0.036
71847998|NCT00910962|143210628|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.047|TWO_SIDED|95.0|-0.28|0.0|||Repeated measures ANCOVA|||||-0.00|-0.28|0.047
71847999|NCT02336958|143210656|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
71678946|NCT00459706|142875793|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.465|TWO_SIDED|95.0|-0.55|0.25|||Regression, Linear|||Prior Injection Experience versus No Prior Injection Experience (reference)||0.25|-0.55|0.465
71899142|NCT00109733|143321400|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||<0.001
71899143|NCT00109733|143321401|SUPERIORITY_OR_OTHER|||||||0.041|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.041
71899144|NCT00109733|143321401|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."||||0.044
71899145|NCT01397071|143321403|OTHER||Mean Difference (Final Values)|2.2||||0.052|TWO_SIDED|95.0|||||t-test, 2 sided|||Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestion||||0.052
71899146|NCT01397071|143321404|OTHER||% of baseline|0.58||||0.03|TWO_SIDED|||||Significance is defined as p\<0.05.|t-test, 2 sided|||Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.||||0.03
71899147|NCT02433288|143321405|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
71899148|NCT02433288|143321406|SUPERIORITY_OR_OTHER|||||||0.0017|||||||Chi-squared|||||||0.0017
71899149|NCT02433288|143321407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|STANDARD_ERROR_OF_MEAN|3.39|<|0.0001|TWO_SIDED|95.0|-26.91|-13.57|||t-test, 2 sided|||||-13.57|-26.91|<0.0001
71899150|NCT02433288|143321408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|1.6||0.3939|TWO_SIDED|95.0|-4.56|1.8|||t-test, 2 sided|||||1.80|-4.56|0.3939
71678947|NCT00459706|142875794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.29||0.154|TWO_SIDED|95.0|-0.97|0.15|||ANOVA|||||0.15|-0.97|0.154
71678948|NCT00459706|142875795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.17||0.212|TWO_SIDED|95.0|-0.12|0.56|||ANOVA|||||0.56|-0.12|0.212
71678949|NCT00459706|142875796|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.19||0.965|TWO_SIDED|95.0|-0.39|0.37|||ANOVA|||||0.37|-0.39|0.965
71899151|NCT02433288|143321409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|1.99||0.7514|TWO_SIDED|95.0|-3.27|4.53|||ANCOVA|linear model including terms for randomized group and baseline LDL-C||||4.53|-3.27|0.7514
71899152|NCT00367640|143321410|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0006
71816016|NCT03500640|143134373|SUPERIORITY|The p value provided here is for the physical component summary score (PCS) only||||||0.16|||||||t-test, 2 sided|||||||0.160
71678950|NCT00459706|142875797|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.19||0.519|TWO_SIDED|95.0|-0.25|0.5|||ANOVA|||||0.50|-0.25|0.519
71816017|NCT03500640|143134374|SUPERIORITY|||||||0.196||||||The a priori threshold for significance is 0.05|t-test, 2 sided|||||||0.196
71816018|NCT03500640|143134375|SUPERIORITY|||||||0.532||||||The a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.532
71816019|NCT05458024|143134385|SUPERIORITY||Beta coefficient|-0.14||||0.83|TWO_SIDED||||||Mixed Models Analysis|||||||0.83
71816020|NCT05458024|143134386|SUPERIORITY||Beta coefficient|-1.41||||0.21|TWO_SIDED|||||Analyses were adjusted for sex, baseline pain, and baseline vitamin D levels.|Mixed Models Analysis|||||||0.21
71816021|NCT01483937|143134434|SUPERIORITY_OR_OTHER|||||||0.533||95.0|||||ANOVA|||||||.533
71816022|NCT01508013|143134443|SUPERIORITY_OR_OTHER|||||||0.633|||||||Mixed Models Analysis|||||||.633
71816023|NCT01508013|143134444|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
71816024|NCT01508013|143134445|SUPERIORITY_OR_OTHER|||||||0.018|||||||Mixed Models Analysis|||||||.018
71816025|NCT04534114|143134461|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.94||||0.944|TWO_SIDED|95.0|0.19|4.68|||Log Rank|||||4.68|0.19|0.944
71816026|NCT04534114|143134461|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.95||||0.953|TWO_SIDED|95.0|0.19|4.72|||Log Rank|||||4.72|0.19|0.953
71816027|NCT04534114|143134461|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.63||||0.605|TWO_SIDED|95.0|0.1|3.75|||Log Rank|||||3.75|0.10|0.605
71816028|NCT04534114|143134462|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.45||||0.612|TWO_SIDED|95.0|0.34|6.08|||Log Rank|||||6.08|0.34|0.612
71816029|NCT04534114|143134462|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|1.27||||0.757|TWO_SIDED|95.0|0.28|5.66|||Log Rank|||||5.66|0.28|0.757
71816030|NCT04534114|143134462|OTHER|Fesomersen groups were compared to the placebo group using two-sided log-rank tests. Due to the exploratory nature of these analyses, no multiplicity adjustment was done. Cause-specific hazard ratio and corresponding 2-sided 95% confidence intervals, comparing the hazards for the event-of-interest in each of the Fesomersen groups with the placebo group were estimated based on three separate cause-specific Cox proportional hazards models as exploratory analysis.|Cause specific Hazard ratio|0.91||||0.909|TWO_SIDED|95.0|0.18|4.52|||Log Rank|||||4.52|0.18|0.909
71816031|NCT03287414|143134469|SUPERIORITY||Least Squares Mean Difference|0.063|STANDARD_ERROR_OF_MEAN|0.1379||0.3248|TWO_SIDED|80.0|-0.115|0.241||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.241|-0.115|0.3248
71816032|NCT03287414|143134470|OTHER|||||||0.868|||||||Log Rank|||||||0.868
71816033|NCT03287414|143134472|OTHER||Hazard Ratio (HR)|2.6||||0.921|TWO_SIDED|80.0|1.1|6.3|||Log Rank|||PFS1||6.3|1.1|0.921
71816034|NCT03287414|143134472|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||PFS2||5.6|0.9|0.863
71816035|NCT03287414|143134473|OTHER||Hazard Ratio (HR)|2.2||||0.863|TWO_SIDED|80.0|0.9|5.6|||Log Rank|||FVC||5.6|0.9|0.863
71816036|NCT03287414|143134473|OTHER||Hazard Ratio (HR)|0.9||||0.457|TWO_SIDED|80.0|0.4|2.0|||Log Rank|||DLCO||2.0|0.4|0.457
71816037|NCT03287414|143134473|OTHER||Hazard Ratio (HR)|0.3||||0.019|TWO_SIDED|80.0|0.1|0.6|||Log Rank|||6MWD||0.6|0.1|0.019
71848000|NCT02336958|143210657|SUPERIORITY_OR_OTHER|||||||0.459|TWO_SIDED||||||t-test, 2 sided|||||||0.459
71816038|NCT03287414|143134474|OTHER||Hazard Ratio (HR)|1.1||||0.611|TWO_SIDED|80.0|0.6|2.0|||Log Rank|||Composite Endpoint 1||2.0|0.6|0.611
71899153|NCT00367640|143321410|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.0001
71899154|NCT00367640|143321410|SUPERIORITY_OR_OTHER|||||||0.4606|TWO_SIDED|||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.||||0.4606
71899155|NCT00406315|143321413|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.53|||||ONE_SIDED|95.0|||||||A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16.||||
71899156|NCT00406315|143321413|SUPERIORITY_OR_OTHER_LEGACY||One-sided upper confidence limit|-0.33|||||ONE_SIDED|95.0|||||||A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.||||
71816039|NCT03287414|143134474|OTHER||Hazard Ratio (HR)|1.1||||0.549|TWO_SIDED|80.0|0.6|1.9|||Log Rank|||Composite Endpoint 2||1.9|0.6|0.549
71816040|NCT03287414|143134475|SUPERIORITY||Least Squares of the Mean|-0.92|STANDARD_ERROR_OF_MEAN|1.3109||0.7576|TWO_SIDED|80.0|-2.615|0.774||1-sided p-values were obtained using MMRM Model.|MMRM|||||0.774|-2.615|0.7576
71816041|NCT03287414|143134476|SUPERIORITY||Least Squares of the Mean|32.222|STANDARD_ERROR_OF_MEAN|61.8632||0.3018|TWO_SIDED|80.0|-47.572|112.015||1-sided p-values were obtained using MMRM Model.|MMRM|||||112.015|-47.572|0.3018
71816042|NCT03287414|143134477|SUPERIORITY||Least Squares of the Mean|29.166|STANDARD_ERROR_OF_MEAN|60.0143||0.314|TWO_SIDED|80.0|-48.22|106.553||1-sided p-values were obtained using MMRM Model.|MMRM|||||106.553|-48.220|0.3140
71816043|NCT03287414|143134478|SUPERIORITY||Least Squares of the mean|1.77|STANDARD_ERROR_OF_MEAN|1.5422||0.1269|TWO_SIDED|80.0|-0.219|3.759||1-sided p-values were obtained using MMRM Model.|MMRM|||||3.759|-0.219|0.1269
71816044|NCT01316770|143134503|SUPERIORITY|The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.||||||0.236||||||No corrections were made for multiple comparisons because there was only one primary hypothesis.|one-sided Paired t-test|||The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction \[that was specified in the statistical analysis plan (SAP) for the mixed model\] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.||||0.236
71816045|NCT01316770|143134504|SUPERIORITY|||||||0.662|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.662
71816046|NCT01316770|143134505|SUPERIORITY|||||||0.607|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.607
71816047|NCT01316770|143134506|SUPERIORITY|||||||0.586|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.||||0.586
71816048|NCT01316770|143134520|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.500
71816049|NCT01316770|143134520|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
71816050|NCT01316770|143134520|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.500
71848001|NCT04679675|143210658|SUPERIORITY||Risk Ratio (RR)|1.3||||0.05|TWO_SIDED|95.0|1.23|1.36|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Direct-Mail versus Education analysis.||1.36|1.23|0.05
71848002|NCT04679675|143210658|SUPERIORITY||Risk Ratio (RR)|1.07||||0.05|TWO_SIDED|95.0|1.02|1.12|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Adherent (population):Opt-In versus Education analysis.||1.12|1.02|.05
71848003|NCT04679675|143210658|SUPERIORITY||Risk Ratio (RR)|1.9||||0.05|TWO_SIDED|95.0|1.68|2.16|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Overdue (population):Direct-Mail versus Education analysis.||2.16|1.68|.05
71848004|NCT04679675|143210658|SUPERIORITY||Risk Ratio (RR)|1.14||||0.05|TWO_SIDED|95.0|1.03|1.25|||Poisson Regression with GEE|||Primary analysis stratified by screening history. These results are for Screening-Unknown (population):Opt-In versus Education analysis.||1.25|1.03|.05
71848005|NCT02234141|143210666|OTHER|Nonparametric pairwise comparison|||||=|0.214||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving {1, 2, or greater than or equal to \[≥\] 3}).||||= 0.214
71848006|NCT02234141|143210666|OTHER|Nonparametric pairwise comparison|||||=|0.27||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.270
71848007|NCT02234141|143210666|OTHER|Nonparametric pairwise comparison|||||=|0.604||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test)|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable \[yes/no\] and the number of background PAH therapies they were receiving \[1, 2, or ≥ 3\]).||||= 0.604
71848008|NCT00621842|143210688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|||<|0.01|TWO_SIDED|95.0|-18.0|-12.9|||t-test, 2 sided|df=53||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-18.0|<.01
71848009|NCT00621842|143210690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.2|||<|0.01|TWO_SIDED|95.0|-17.5|-12.9|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||-12.9|-17.5|<.01
71848010|NCT00621842|143210691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.49|TWO_SIDED|95.0|-1.82|0.88|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.||.88|-1.82|.49
71848011|NCT00621842|143210692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|||<|0.01|TWO_SIDED|95.0|-2.43|-1.68|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-1.68|-2.43|<.01
71848012|NCT00621842|143210693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8|TWO_SIDED|95.0|-0.36|0.28|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.28|-.36|.80
71848013|NCT00621842|143210694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.36||95.0|-0.97|2.62|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||2.62|-.97|.36
71848014|NCT00621842|143210696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.08|TWO_SIDED|95.0|-1.67|0.09|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||.09|-1.67|.08
71848015|NCT00621842|143210697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.04||95.0|-1.03|-0.04|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.||-.04|-1.03|.04
71848016|NCT04604652|143210704|OTHER||||||=|0.077|||||||t-test, 1 sided|||A t-test was performed to test for the percent change from baseline to Week 12. This analysis was based on observed data without imputation. Testing was one sided using a 5% alpha level. No multiplicity adjustment was used, and the p-values reported for the endpoints were descriptive in nature.||||=0.077
71848017|NCT03692871|143210713|OTHER||Difference in Percentage|7.9|||=|0.003|TWO_SIDED|95.0|2.8|12.8|||Miettinen & Nurminen method|||Injection-site erythema||12.8|2.8|= 0.003
71848018|NCT03692871|143210713|OTHER||Difference in Percentage|-0.3|||=|0.882|TWO_SIDED|95.0|-5.0|4.0|||Miettinen & Nurminen method|||Injection-site induration||4.0|-5.0|= 0.882
71848019|NCT03692871|143210713|OTHER||Difference in Percentage|6.4|||=|0.014|TWO_SIDED|95.0|1.3|11.3|||Miettinen & Nurminen method|||Injection-site pain||11.3|1.3|= 0.014
71848020|NCT03692871|143210713|OTHER||Difference in Percentage|4.6|||=|0.051|TWO_SIDED|95.0|0.0|8.9|||Miettinen & Nurminen method|||Injection-site swelling||8.9|0.0|= 0.051
71848021|NCT03692871|143210714|OTHER||Difference in Percentage|5.5|||=|0.033|TWO_SIDED|95.0|0.4|10.5|||Miettinen & Nurminen method|||Decreased appetite||10.5|0.4|= 0.033
71816051|NCT01316770|143134520|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
71816052|NCT01316770|143134522|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
71848022|NCT03692871|143210714|OTHER||Difference in Percentage|5.6|||=|0.016|TWO_SIDED|95.0|1.0|10.5|||Miettinen & Nurminen method|||Irritability||10.5|1.0|= 0.016
71848023|NCT03692871|143210714|OTHER||Difference in Percentage|0.4|||=|0.878|TWO_SIDED|95.0|-4.7|5.6|||Miettinen & Nurminen method|||Somnolence||5.6|-4.7|= 0.878
71848024|NCT03692871|143210714|OTHER||Difference in Percentage|-0.8|||=|0.503|TWO_SIDED|95.0|-3.8|1.5|||Miettinen & Nurminen method|||Urticaria||1.5|-3.8|= 0.503
71848025|NCT03692871|143210715|OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-0.8|0.4||||||Percentage of participants with a vaccine-related SAE||0.4|-0.8|
71848026|NCT03182244|143210735|SUPERIORITY||Hazard Ratio (HR)|0.612||||0.00152|TWO_SIDED|95.0|0.451|0.832|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per interactive response technology (IRT).|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.832|0.451|0.00152
71899157|NCT00406315|143321414|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-8.48|2.41||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.41|-8.48|
71816053|NCT01316770|143134522|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
71848027|NCT03182244|143210736|SUPERIORITY||Hazard Ratio (HR)|0.589||||5e-05|TWO_SIDED|95.0|0.438|0.792|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||0.792|0.438|0.00005
71848028|NCT03182244|143210737|SUPERIORITY||Treatment difference|8.9||||0.04256|TWO_SIDED|95.0|0.3|17.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||17.5|0.3|0.04256
71848029|NCT03182244|143210738|SUPERIORITY||Hazard Ratio (HR)|1.163||||0.8871|TWO_SIDED|95.0|0.131|10.338|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||10.338|0.131|0.88710
71848030|NCT03182244|143210739|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.55969|TWO_SIDED|95.0|0.209|2.414|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||2.414|0.209|0.55969
71848031|NCT03182244|143210740|SUPERIORITY||Hazard Ratio (HR)|1.583||||0.66261|TWO_SIDED|95.0|0.192|13.048|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||13.048|0.192|0.66261
71848032|NCT03182244|143210741|SUPERIORITY||Hazard Ratio (HR)|0.756||||0.55731|TWO_SIDED|95.0|0.286|1.999|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.999|0.286|0.55731
71848033|NCT03182244|143210742|SUPERIORITY||Treatment difference|17.7||||0.00049|TWO_SIDED|95.0|7.9|27.5|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||27.5|7.9|0.00049
71848034|NCT03182244|143210744|SUPERIORITY||Hazard Ratio (HR)|0.857||||0.56944|TWO_SIDED|95.0|0.494|1.487|||Log Rank|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|Based on Cox proportional hazard model. Assuming proportional hazards, an HR \< 1 indicates a reduction in hazard rate where the numerator is the Gilteritinib arm and the denominator is the Salvage chemotherapy arm.|||1.487|0.494|0.56944
71848035|NCT03182244|143210745|SUPERIORITY||Treatment difference|31.2|||<|1e-05|TWO_SIDED|95.0|20.2|42.3|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||42.3|20.2|<0.00001
71848036|NCT03182244|143210751|SUPERIORITY||Treatment difference|14.7||||0.00055|TWO_SIDED|95.0|6.5|22.8|||Cochran-Mantel-Haenszel|Stratification factors: first-line AML therapy \& preselected salvage chemotherapy/IRT response. Treatment difference based on stratification factors.||||22.8|6.5|0.00055
71848037|NCT03182244|143210752|SUPERIORITY||Least square mean difference|0.6||||0.14841||||||Analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. LS Mean difference was estimated using chemotherapy as control.|ANCOVA|||||||0.14841
71678951|NCT00459706|142875798|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.33|2.57|||GEE model+logit link+multinomial distrib|||Day 84||2.57|1.33|<0.001
71678952|NCT00459706|142875799|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.007|TWO_SIDED|95.0|1.14|2.29|||GEE model+logit link+multinomial distrib|||||2.29|1.14|0.007
71678953|NCT00459706|142875800|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.002|TWO_SIDED|95.0|1.26|2.92|||GEE model+logit link+multinomial distrib|||||2.92|1.26|0.002
71816054|NCT01316770|143134523|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
71816055|NCT01316770|143134523|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
71848038|NCT02060487|143210773|NON_INFERIORITY|Non-inferiority of sildenafil 20 mg TID versus sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% confidence interval (CI) for hazard ratio (HR) was less than 2.|Hazard Ratio (HR)|0.68|||||TWO_SIDED|99.7|0.31|1.49|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.49|0.31|
71848039|NCT02060487|143210773|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 5 mg TID was to be concluded if the upper limit of the 99.7% CI for HR was less than 2.|Hazard Ratio (HR)|0.51|||||TWO_SIDED|99.7|0.22|1.21|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.22|
71848040|NCT02060487|143210773|NON_INFERIORITY|Non-inferiority of sildenafil 80 mg TID vs. sildenafil 20 mg TID was to be concluded if the upper limit of the 99.7% CI for HR is less than 2.|Hazard Ratio (HR)|0.74|||||TWO_SIDED|99.7|0.3|1.84|||||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.84|0.30|
71848041|NCT02060487|143210774|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.035|TWO_SIDED|99.7|0.33|1.21|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.21|0.33|0.035
71678954|NCT00459706|142875801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.65|3.46|||GEE model+logit link+multinomial distrib|||||3.46|1.65|<0.001
71678955|NCT00459706|142875802|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001|TWO_SIDED|95.0|1.5|2.83|||GEE model+logit link+multinomial distrib|||||2.83|1.50|<0.001
71678956|NCT00459706|142875803|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.44|2.78|||GEE model+logit link+multinomial distrib|||||2.78|1.44|<0.001
71848042|NCT02060487|143210774|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|99.7|0.22|0.89|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||0.89|0.22|<0.001
71848043|NCT02060487|143210774|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.195|TWO_SIDED|99.7|0.34|1.52|||Wald test||Hazard ratio estimated from the Proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH.|||1.52|0.34|0.195
71848044|NCT02060487|143210775|SUPERIORITY||Least-squares means difference|15.0||||0.0627|TWO_SIDED|95.0|-0.8|30.81|||MMRM|||||30.81|-0.80|0.0627
71848045|NCT02060487|143210775|SUPERIORITY||Least-squares means difference|18.9||||0.0201|TWO_SIDED|95.0|2.99|34.86|||MMRM|||||34.86|2.99|0.0201
71848046|NCT02060487|143210775|SUPERIORITY||Least-squares means difference|3.9||||0.6254|TWO_SIDED|95.0|-11.85|19.68|||MMRM|||||19.68|-11.85|0.6254
71899158|NCT00406315|143321415|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.2|||||TWO_SIDED|95.0|-1.82|1.44||||||HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||1.44|-1.82|
71899159|NCT00406315|143321415|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.5|||||TWO_SIDED|95.0|-7.07|2.09||||||LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.09|-7.07|
71848047|NCT02060487|143210776|SUPERIORITY||Least-squares means difference|21.3||||0.0286|TWO_SIDED|95.0|2.25|40.45|||MMRM|||||40.45|2.25|0.0286
71678957|NCT00459706|142875804|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.184|TWO_SIDED|95.0|0.9|1.72|||GEE model+logit link+multinomial distrib|||||1.72|0.90|0.184
71678958|NCT00459706|142875805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.106|TWO_SIDED|95.0|0.94|1.85|||GEE model+logit link+multinomial distrib|||||1.85|0.94|0.106
71678959|NCT00459706|142875806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.112|TWO_SIDED|95.0|0.93|1.96|||GEE model+logit link+multinomial distrib|||||1.96|0.93|0.112
71678960|NCT00459706|142875807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.21|2.24|||GEE model+logit link+multinomial distrib|||||2.24|1.21|0.002
71678961|NCT00459706|142875808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57|||<|0.001|TWO_SIDED|95.0|0.41|0.78|||GEE model+logit link+multinomial distrib|||||0.78|0.41|<0.001
71678962|NCT00459706|142875809|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.022|TWO_SIDED|95.0|0.47|0.94|||GEE model+logit link+multinomial distrib|||||0.94|0.47|0.022
71678963|NCT00459706|142875810|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.009|TWO_SIDED|95.0|0.46|0.89|||GEE model+logit link+multinomial distrib|||||0.89|0.46|0.009
71678964|NCT00459706|142875811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.007|TWO_SIDED|95.0|0.45|0.88|||GEE model+logit link+multinomial distrib|||||0.88|0.45|0.007
71848048|NCT02060487|143210776|SUPERIORITY||Least-squares means difference|20.5||||0.0364|TWO_SIDED|95.0|1.3|39.65|||MMRM|||||39.65|1.30|0.0364
71848049|NCT02060487|143210776|SUPERIORITY||Least-squares means difference|-0.9||||0.9283|TWO_SIDED|95.0|-19.94|18.19|||MMRM|||||18.19|-19.94|0.9283
71899160|NCT00406315|143321415|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.6|||||TWO_SIDED|95.0|-16.44|13.15||||||Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||13.15|-16.44|
71899161|NCT00406315|143321416|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.1|||||TWO_SIDED|95.0|-0.02|0.14||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.14|-0.02|
71899162|NCT00406315|143321417|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.0|||||TWO_SIDED|95.0|-0.09|6.15||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.15|-0.09|
71899163|NCT00406315|143321418|SUPERIORITY_OR_OTHER_LEGACY||Mean|134.8|||||TWO_SIDED|95.0|-20.43|289.98||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||289.98|-20.43|
71899164|NCT00406315|143321419|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.9|||||TWO_SIDED|95.0|-5.93|0.11||||||Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-5.93|
71899165|NCT00406315|143321419|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.0|||||TWO_SIDED|95.0|-6.2|0.1||||||Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.10|-6.20|
71899166|NCT00406315|143321420|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.05|||||TWO_SIDED|95.0|-0.32|0.42||||||Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.42|-0.32|
71899167|NCT00406315|143321420|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.11|-0.05|
71899168|NCT00406315|143321420|SUPERIORITY_OR_OTHER_LEGACY||Mean|0.01|||||TWO_SIDED|95.0|-0.06|0.07||||||Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||0.07|-0.06|
71899169|NCT00406315|143321421|SUPERIORITY_OR_OTHER_LEGACY||Mean|-10.22|||||TWO_SIDED|95.0|-12.7|-7.75||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-7.75|-12.70|
71678965|NCT00459706|142875812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.014|TWO_SIDED|95.0|0.47|0.92|||GEE model+logit link+multinomial distrib|||||0.92|0.47|0.014
71899170|NCT00406315|143321421|SUPERIORITY_OR_OTHER_LEGACY||Mean|-6.61|||||TWO_SIDED|95.0|-8.59|-4.63||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-4.63|-8.59|
71678966|NCT00459706|142875813|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.53|2.88|||GEE model+logit link+multinomial distrib|||||2.88|1.53|<0.001
71678967|NCT00459706|142875814|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.57|2.91|||GEE model+logit link+multinomial distrib|||||2.91|1.57|<0.001
71678968|NCT00459706|142875815|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|2.23|4.25|||GEE model+logit link+multinomial distrib|||||4.25|2.23|<0.001
71899171|NCT00406315|143321421|SUPERIORITY_OR_OTHER_LEGACY||Mean|-3.3|||||TWO_SIDED|95.0|-4.07|-2.53||||||Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.53|-4.07|
71899172|NCT00406315|143321421|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.43|||||TWO_SIDED|95.0|-3.03|-1.83||||||Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.03|
71899173|NCT00406315|143321421|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.67|||||TWO_SIDED|95.0|-2.36|-0.99||||||Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.36|
71899174|NCT00406315|143321421|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.92|||||TWO_SIDED|95.0|-1.48|-0.35||||||Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.35|-1.48|
71899175|NCT00406315|143321422|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.76|||||TWO_SIDED|95.0|-0.9|-0.61||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.61|-0.90|
71899176|NCT00406315|143321422|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.47|||||TWO_SIDED|95.0|-0.58|-0.36||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.36|-0.58|
71899177|NCT00406315|143321423|SUPERIORITY_OR_OTHER_LEGACY||Mean|2.7|||||TWO_SIDED|95.0|2.52|2.88||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||2.88|2.52|
71899178|NCT00406315|143321423|SUPERIORITY_OR_OTHER_LEGACY||Mean|3.2|||||TWO_SIDED|95.0|3.02|3.34||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||3.34|3.02|
71899179|NCT00406315|143321424|SUPERIORITY_OR_OTHER_LEGACY||Mean|-2.55|||||TWO_SIDED|95.0|-3.27|-1.83||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-1.83|-3.27|
71899180|NCT00406315|143321424|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.58|||||TWO_SIDED|95.0|-2.16|-0.99||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.99|-2.16|
71899181|NCT00406315|143321425|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.61|||||TWO_SIDED|95.0|-5.95|-3.26||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-3.26|-5.95|
71899182|NCT00406315|143321425|SUPERIORITY_OR_OTHER_LEGACY||Mean|-4.21|||||TWO_SIDED|95.0|-5.57|-2.85||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-2.85|-5.57|
71899183|NCT00406315|143321425|SUPERIORITY_OR_OTHER_LEGACY||Mean|-1.02|||||TWO_SIDED|95.0|-1.31|-0.73||||||Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.73|-1.31|
71899184|NCT00406315|143321425|SUPERIORITY_OR_OTHER_LEGACY||Mean|-0.88|||||TWO_SIDED|95.0|-1.13|-0.63||||||Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||-0.63|-1.13|
71899185|NCT00406315|143321426|SUPERIORITY_OR_OTHER_LEGACY||Mean|7.88|||||TWO_SIDED|95.0|6.07|9.69||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.69|6.07|
71899186|NCT00406315|143321426|SUPERIORITY_OR_OTHER_LEGACY||Mean|5.27|||||TWO_SIDED|95.0|3.89|6.65||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||6.65|3.89|
71899187|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
71899188|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|10.49|||||TWO_SIDED|95.0|5.95|15.02||||||Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||15.02|5.95|
71899189|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
71899190|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|18.49|||||TWO_SIDED|95.0|11.94|25.04||||||Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||25.04|11.94|
71899191|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
71848050|NCT03055988|143210810|SUPERIORITY||Adjusted mean difference|-0.537|STANDARD_ERROR_OF_MEAN|1.12||0.6331|TWO_SIDED|95.0|-2.779|1.705|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|Mixed model repeated measures (MMRM) model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation. H0: Mean change from baseline in LVEDVI for (Tiotropium + Olodaterol) = Mean change from baseline in LVEDVI for (Fluticasone propionate + Salmeterol)||1.705|-2.779|0.6331
71848051|NCT03055988|143210811|SUPERIORITY||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.036||0.9817|TWO_SIDED|95.0|-0.072|0.074|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.074|-0.072|0.9817
71848052|NCT03055988|143210812|SUPERIORITY||Adjusted mean difference|1.28|STANDARD_ERROR_OF_MEAN|1.995||0.5238|TWO_SIDED|95.0|-2.719|5.279|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.279|-2.719|0.5238
71848053|NCT03055988|143210813|SUPERIORITY||Adjusted mean difference|2.069|STANDARD_ERROR_OF_MEAN|1.853||0.2687|TWO_SIDED|95.0|-1.64|5.779|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||5.779|-1.640|0.2687
71848054|NCT03055988|143210814|SUPERIORITY||Adjusted mean difference|0.409|STANDARD_ERROR_OF_MEAN|1.335||0.7604|TWO_SIDED|95.0|-2.264|3.082|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||3.082|-2.264|0.7604
71848055|NCT03055988|143210815|SUPERIORITY||Adjusted mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.509||0.833|TWO_SIDED|95.0|-3.341|2.702|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||2.702|-3.341|0.8330
71848056|NCT03055988|143210816|SUPERIORITY||Adjusted mean difference|-7.957|STANDARD_ERROR_OF_MEAN|2.452||0.0019|TWO_SIDED|95.0|-12.865|-3.05|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||-3.050|-12.865|0.0019
71848057|NCT03055988|143210817|SUPERIORITY||Adjusted mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.121|0.24|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.240|0.121|<0.0001
71899192|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|6.45|||||TWO_SIDED|95.0|2.98|9.93||||||Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||9.93|2.98|
71899193|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
71899194|NCT00406315|143321427|SUPERIORITY_OR_OTHER_LEGACY||Mean|15.32|||||TWO_SIDED|95.0|9.97|20.68||||||Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.||20.68|9.97|
71899195|NCT01525849|143321429|NON_INFERIORITY_OR_EQUIVALENCE|Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.|||||<|0.001|||||||t-test, 1 sided|||Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.||||<0.001
71899196|NCT01525849|143321430|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.||||<0.0001
71899197|NCT01525849|143321431|SUPERIORITY_OR_OTHER|||||||0.628|||||||t-test, 2 sided|||||||0.628
71678969|NCT00459706|142875816|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||<|0.001|TWO_SIDED|95.0|1.35|2.62|||GEE model+logit link+multinomial distrib|||||2.62|1.35|<0.001
71848058|NCT03055988|143210818|SUPERIORITY||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|0.171|0.4|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 - F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.||0.400|0.171|<0.0001
71848059|NCT01736475|143210822|SUPERIORITY_OR_OTHER_LEGACY||Ratio of means|0.1|||<|0.0001|TWO_SIDED|95.0|0.06|0.19|||Regression, Negative binomial|||Ratio Annualized Bleeding Rate (ABR) Prophylaxis/On-demand: Prophylaxis treatment w ill be considered to be successful if the upper limit of the 95% CI for the ratio between treatment regimen does not exceed 0.5 (corresponding to a 50% reduction of the mean ABR compared to the on-demand treatment). H01: μ1 ≥0.5\*μ2 Ha1: μ1\<0.5\*μ2 w here μ1 and μ2 are the mean ABRs in on prophylaxis and on-demand, respectively||0.19|0.06|<0.0001
71848060|NCT01190124|143210896|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline||||<0.001
71848061|NCT01190124|143210899|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline||||<0.001
71848062|NCT01190124|143210912|SUPERIORITY_OR_OTHER|||||||0.007|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24||||0.007
71848063|NCT01190124|143210913|SUPERIORITY_OR_OTHER|||||||0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48||||0.001
71848064|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.101|||||||ANOVA|||Baseline (AM)||||0.101
71848065|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.168|||||||ANOVA|||Change at Week 1 (AM)||||0.168
71899198|NCT01525849|143321433|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71899199|NCT00339183|143321434|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-2.91||||0.0036|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.0036
71678970|NCT00459706|142875817|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.25|||<|0.001|TWO_SIDED|95.0|0.18|0.34|||GEE model+logit link+multinomial distrib|||||0.34|0.18|<0.001
71678971|NCT00459706|142875818|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.19|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.19|<0.001
71848066|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||ANOVA|||Change at Week 2 (AM)||||0.930
71848067|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.487|||||||ANOVA|||Change at Week 3 (AM)||||0.487
71848068|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.914|||||||ANOVA|||Change at Week 4 (AM)||||0.914
71848069|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|||||||ANOVA|||Change at Final Week (AM)||||0.977
71848070|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.109|||||||ANOVA|||Baseline (PM)||||0.109
71848071|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.291|||||||ANOVA|||Change at Week 1 (PM)||||0.291
71678972|NCT00459706|142875819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27|||<|0.001|TWO_SIDED|95.0|0.2|0.36|||GEE model+logit link+multinomial distrib|||||0.36|0.20|<0.001
71848072|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|||||||ANOVA|||Change at Week 2 (PM)||||0.984
71848073|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Change at Week 3 (PM)||||0.373
71848074|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.623|||||||ANOVA|||Change at Week 4 (PM)||||0.623
71848075|NCT00070707|143210932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978|||||||ANOVA|||Change at Final Week (PM)||||0.978
71848076|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||Baseline (AM)||||0.023
71848077|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 1 (AM)||||0.693
71848078|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.483|||||||ANOVA|||Change at Week 2 (AM)||||0.483
71848079|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088|||||||ANOVA|||Change at Week 3 (AM)||||0.088
71848080|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||ANOVA|||Change at Week 4 (AM)||||0.210
71848081|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||ANOVA|||Change at Final Week (AM)||||0.178
71848082|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055|||||||ANOVA|||Baseline (PM)||||0.055
71848083|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Week 1 (PM)||||0.915
71848084|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.471|||||||ANOVA|||Change at Week 2 (PM)||||0.471
71848085|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||ANOVA|||Change at Week 3 (PM)||||0.110
71848086|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|||||||ANOVA|||Change at Week 4 (PM)||||0.305
71816056|NCT01316770|143134523|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
71816057|NCT01316770|143134523|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
71816058|NCT01316770|143134526|OTHER|||||||0.25|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||0.250
71816059|NCT01316770|143134526|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||1.000
71816060|NCT01316770|143134526|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||1.000
71816061|NCT01316770|143134526|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
71816062|NCT01316770|143134527|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."||||1.000
71816063|NCT01316770|143134527|OTHER|||||||0.625|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."||||0.625
71816064|NCT01316770|143134527|OTHER|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."||||0.5000
71816065|NCT01316770|143134527|OTHER|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."||||1.000
71816066|NCT02294474|143134557|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 \& Humalog\>-0.3%.|Least Square (LS) Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.215|0.067|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.067|-0.215|
71816067|NCT05200936|143134566|SUPERIORITY|||||||0.7145||||||p-value is 1-sided|Mixed Models Analysis|||||||0.7145
71816068|NCT05200936|143134567|SUPERIORITY|||||||0.9613|||||||ANCOVA|||||||0.9613
71848087|NCT00070707|143210933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|||||||ANOVA|||Change at Final Week (PM)||||0.461
71848088|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANOVA|||Baseline (AM)||||0.068
71848089|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Change at Week 1 (AM)||||0.116
71848090|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.749|||||||ANOVA|||Change at Week 2 (AM)||||0.749
71899200|NCT00339183|143321434|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.46||||0.1448|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.||||0.1448
71899201|NCT00339183|143321435|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-1.57||||0.1154|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.||||0.1154
71899202|NCT00339183|143321435|SUPERIORITY_OR_OTHER_LEGACY||Normal score|-0.6||||0.5503|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score \<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.||||0.5503
71678973|NCT00459706|142875820|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.196|TWO_SIDED|95.0|0.61|1.11|||GEE model+logit link+multinomial distrib|||||1.11|0.61|0.196
71678974|NCT00459706|142875821|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.001|TWO_SIDED|95.0|1.25|2.42|||GEE model+logit link+multinomial distrib|||||2.42|1.25|0.001
71678975|NCT00459706|142875822|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.21|0.42|||GEE model+logit link+multinomial distrib|||||0.42|0.21|<0.001
71678976|NCT00459706|142875823|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.29|0.56|||GEE model+logit link+multinomial distrib|||||0.56|0.29|<0.001
71678977|NCT00459706|142875824|SUPERIORITY_OR_OTHER|||||||0.896|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.896
71678978|NCT00459706|142875824|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.166
71678979|NCT00459706|142875825|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
71678980|NCT00459706|142875825|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
71816069|NCT01672853|143134579|SUPERIORITY||Difference in LS Mean|-0.4|||||TWO_SIDED|95.0|-2.3|1.6||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||1.6|-2.3|
71678981|NCT00459706|142875826|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.069
71678982|NCT00459706|142875826|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.015
71678983|NCT00459706|142875827|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
71678984|NCT00459706|142875827|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
71678985|NCT00459706|142875828|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
71678986|NCT00459706|142875828|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
71678987|NCT00459706|142875829|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.652
71678988|NCT00459706|142875829|SUPERIORITY_OR_OTHER|||||||0.459||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.459
71678989|NCT00459706|142875830|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.023
71678990|NCT00459706|142875830|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
71678991|NCT00459706|142875831|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.038
71678992|NCT00459706|142875831|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
71678993|NCT00459706|142875832|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.018
71678994|NCT00459706|142875832|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.019
71678995|NCT00459706|142875833|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.049
71678996|NCT00459706|142875833|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.736
71678997|NCT00459706|142875834|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.033
71678998|NCT00459706|142875834|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.730
71678999|NCT00459706|142875835|SUPERIORITY_OR_OTHER|||||||0.838||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.838
71899203|NCT00339183|143321436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.33|||<|0.0001|TWO_SIDED|95.0|3.21|8.6|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||8.60|3.21|<0.0001
71848091|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.289|||||||ANOVA|||Change at Week 3 (AM)||||0.289
71848092|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.982|||||||ANOVA|||Change at Week 4 (AM)||||0.982
71848093|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.941|||||||ANOVA|||Change at Final Week (AM)||||0.941
71848094|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|||||||ANOVA|||Baseline (PM)||||0.128
71848095|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|||||||ANOVA|||Change at Week 1 (PM)||||0.484
71848096|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||ANOVA|||Change at Week 2 (PM)||||0.673
71848097|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 3 (PM)||||0.250
71848098|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45|||||||ANOVA|||Change at Week 4 (PM)||||0.450
71848099|NCT00070707|143210934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.774|||||||ANOVA|||Change at Final Week (PM)||||0.774
71848100|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANOVA|||Baseline (AM)||||0.078
71848101|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492|||||||ANOVA|||Change at Week 1 (AM)||||0.492
71848102|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||ANOVA|||Change at Week 2 (AM)||||0.945
71848103|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|||||||ANOVA|||Change at Week 3 (AM)||||0.359
71848104|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.802|||||||ANOVA|||Change at Week 4 (AM)||||0.802
71848105|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|||||||ANOVA|||Change at Final Week (AM)||||0.716
71848106|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.158|||||||ANOVA|||Baseline (PM)||||0.158
71848107|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.281|||||||ANOVA|||Change at Week 1 (PM)||||0.281
71848108|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.901|||||||ANOVA|||Change at Week 2 (PM)||||0.901
71848109|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.433|||||||ANOVA|||Change at Week 3 (PM)||||0.433
71848110|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|||||||ANOVA|||Change at Week 4 (PM)||||0.730
71848111|NCT00070707|143210935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.819|||||||ANOVA|||Change at Final Week (PM)||||0.819
71848112|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629|||||||ANOVA|||Baseline (AM)||||0.629
71848113|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038|||||||ANOVA|||Change at Week 1 (AM)||||0.038
71848114|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.182|||||||ANOVA|||Change at Week 2 (AM)||||0.182
71848115|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 3 (AM)||||0.149
71848116|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||ANOVA|||Change at Week 4 (AM)||||0.035
71848117|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||ANOVA|||Change at Final Week (AM)||||0.056
71848118|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.711|||||||ANOVA|||Baseline (PM)||||0.711
71848119|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098|||||||ANOVA|||Change at Week 1 (PM)||||0.098
71848120|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.356|||||||ANOVA|||Change at Week 2 (PM)||||0.356
71848121|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|||||||ANOVA|||Change at Week 3 (PM)||||0.529
71848122|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617|||||||ANOVA|||Change at Week 4 (PM)||||0.617
71848123|NCT00070707|143210936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||ANOVA|||Change at Final Week (PM)||||0.422
71848124|NCT00070707|143210937|SUPERIORITY_OR_OTHER_LEGACY|Baseline||||||0.532|||||||Cochran-Mantel-Haenszel|||||||0.532
71848125|NCT00070707|143210937|SUPERIORITY_OR_OTHER_LEGACY|Day 15||||||0.739|||||||Cochran-Mantel-Haenszel|||||||0.739
71848126|NCT00070707|143210937|SUPERIORITY_OR_OTHER_LEGACY|Day 29||||||0.227|||||||Cochran-Mantel-Haenszel|||||||0.227
71848127|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||ANOVA|||Baseline (AM)||||0.104
71848128|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 1 (AM)||||0.022
71848129|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANOVA|||Change at Week 2 (AM)||||0.012
71848130|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
71848131|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033|||||||ANOVA|||Change at Week 4 (AM)||||0.033
71848132|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||ANOVA|||Change at Final Week (AM)||||0.047
71848133|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269|||||||ANOVA|||Baseline (PM)||||0.269
71848134|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.308|||||||ANOVA|||Change at Week 1 (PM)||||0.308
71848135|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Change at Week 2 (PM)||||0.050
71848136|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 3 (PM)||||0.014
71848137|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|||||||ANOVA|||Change at Week 4 (PM)||||0.100
71848138|NCT00070707|143210938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|||||||ANOVA|||Change at Final Week (PM)||||0.139
71848139|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Baseline (AM)||||0.136
71848140|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.126|||||||ANOVA|||Change at Week 1 (AM)||||0.126
71848141|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.107|||||||ANOVA|||Change at Week 2 (AM)||||0.107
71848142|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||ANOVA|||Change at Week 3 (AM)||||0.006
71848143|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||Change at Week 4 (AM)||||0.030
71679000|NCT00459706|142875835|SUPERIORITY_OR_OTHER|||||||0.483||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.483
71679001|NCT00459706|142875836|SUPERIORITY_OR_OTHER|||||||0.466||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.466
71679002|NCT00459706|142875836|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.035
71816070|NCT01672853|143134579|SUPERIORITY||Difference in LS Mean|1.0|||||TWO_SIDED|95.0|-1.0|3.0||||||A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.||3.0|-1.0|
71816071|NCT05473000|143134619|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
71816072|NCT00840996|143134634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|97.5|-1.23|-0.4||Test for superiority adjusted for 2 primary comparisons (2 outcomes)|Mixed Models Analysis|Llinear mixed-effects accounts for correlation exhibited by the repeated pain measurements on a given patient (spatial power correlation structure).||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||-0.40|-1.23|<0.001
71816073|NCT00840996|143134635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group|the ratio of the geometric means|0.8||||0.011|TWO_SIDED|95.0|0.65|1.21||Noninferiority hypotheses were evaluated against a one-sided significance criterion of 0.025 \[adjusting for testing in both directions: lidocaine vs. control and vs. control vs. lidocaine \]|Regression, Linear|Log-linear regression model was used; 0.1 mg added before taking the logarithm to accommodate the 2 patients who received 0 mg opioids.||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .||1.21|0.65|0.011
71679003|NCT00459706|142875837|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.784
71679004|NCT00459706|142875837|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.006
71679005|NCT00459706|142875838|SUPERIORITY_OR_OTHER|||||||0.843||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.843
71679006|NCT00459706|142875838|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.461
71679007|NCT00459706|142875839|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.150
71679008|NCT00459706|142875839|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.002
71679009|NCT00459706|142875840|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
71816074|NCT00840996|143134636|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.049|TWO_SIDED|95.0|0.84|1.0|||Regression, Logistic|||||1.00|0.84|0.049
71816075|NCT00840996|143134637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.31|TWO_SIDED|95.0|0.77|1.09|||Regression, Logistic|||Nausea - POD 2||1.09|0.77|0.31
71816076|NCT00840996|143134637|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.14|||Regression, Logistic|||Vomiting - POD 2||1.14|0.94|0.44
71816077|NCT00840996|143134638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.15|TWO_SIDED|95.0|-2.4|0.4|||Regression, Linear|||||0.4|-2.4|0.15
71816078|NCT00840996|143134639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.002|TWO_SIDED|95.0|2.3|10.0|||Regression, Linear|||||10|2.3|0.002
71816079|NCT00840996|143134640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.04|TWO_SIDED|95.0|0.3|8.9|||Regression, Logistic|||||8.9|0.3|0.04
71816080|NCT04867785|143134651|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.188|TWO_SIDED|95.0|-0.94|0.18|||Mixed Models Analysis|||||0.18|-0.94|0.188
71816081|NCT04867785|143134651|SUPERIORITY||LSMean Difference|-1.34|||<|0.001|TWO_SIDED|95.0|-1.84|-0.85|||Mixed Models Analysis|||||-0.85|-1.84|<0.001
71816082|NCT04867785|143134651|SUPERIORITY||LSMean Difference|-1.25|||<|0.001|TWO_SIDED|95.0|-1.85|-0.65|||Mixed Models Analysis|||||-0.65|-1.85|<0.001
71816083|NCT04867785|143134651|SUPERIORITY||LSMean Difference|-1.94|||<|0.001|TWO_SIDED|95.0|-2.44|-1.43|||Mixed Models Analysis|||||-1.43|-2.44|<0.001
71816084|NCT04867785|143134651|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.42|-1.24|||Mixed Models Analysis|||||-1.24|-2.42|<0.001
71816085|NCT04867785|143134651|SUPERIORITY||LSMean Difference|-1.96|||<|0.001|TWO_SIDED|95.0|-2.43|-1.5|||Mixed Models Analysis|||||-1.50|-2.43|<0.001
71816086|NCT04867785|143134652|SUPERIORITY||LSMean Difference|0.98|||<|0.001|TWO_SIDED|95.0|0.52|1.43|||Mixed Models Analysis|||||1.43|0.52|<0.001
71816087|NCT04867785|143134652|SUPERIORITY||LSMean Difference|0.01||||0.935|TWO_SIDED|95.0|-0.34|0.37|||Mixed Models Analysis|||||0.37|-0.34|0.935
71816088|NCT04867785|143134652|SUPERIORITY||LSMean Difference|0.11||||0.668|TWO_SIDED|95.0|-0.39|0.6|||Mixed Models Analysis|||||0.60|-0.39|0.668
71816089|NCT04867785|143134652|SUPERIORITY||LSMean Difference|-0.58||||0.002|TWO_SIDED|95.0|-0.95|-0.21|||Mixed Models Analysis|||||-0.21|-0.95|0.002
71816090|NCT04867785|143134652|SUPERIORITY||LSMean Difference|-0.47||||0.056|TWO_SIDED|95.0|-0.95|0.01|||Mixed Models Analysis|||||0.01|-0.95|0.056
71816091|NCT04867785|143134652|SUPERIORITY||LSMean Difference|-0.61|||<|0.001|TWO_SIDED|95.0|-0.93|-0.29|||Mixed Models Analysis|||||-0.29|-0.93|<0.001
71816092|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-0.24||||0.448|TWO_SIDED|95.0|-0.85|0.38|||Mixed Models Analysis|||||0.38|-0.85|0.448
71816093|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-0.99||||0.001|TWO_SIDED|95.0|-1.6|-0.38|||Mixed Models Analysis|||||-0.38|-1.60|0.001
71899204|NCT00339183|143321436|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.76|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.|||1.76|0.56|1.0000
71899205|NCT02142894|143321440|EQUIVALENCE|The results are analyzed in a 2x2 contingency table with 95%CI.|2 x 2 contingency table|87.9|||||TWO_SIDED|95.0|72.7|95.2||||||||95.2|72.7|
71899206|NCT01455428|143321446|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.188||0.0002|TWO_SIDED|95.0|-1.08|-0.34||Primary analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.34|-1.08|0.0002
71899207|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.149||0.001|TWO_SIDED|95.0|-0.79|-0.2||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.20|-0.79|0.0010
71816094|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.8|-0.59|||Mixed Models Analysis|||||-0.59|-1.80|<0.001
71899208|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.94|-0.35||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.35|-0.94|<0.0001
71899209|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.151||0.0001|TWO_SIDED|95.0|-0.88|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.88|0.0001
71899210|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.152||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
71899211|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0009|TWO_SIDED|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.21|-0.81|0.0009
71899212|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.153||0.0001|TWO_SIDED|95.0|-0.89|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.29|-0.89|0.0001
71899213|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.01|-0.41||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.41|-1.01|<0.0001
71899214|NCT01455428|143321447|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.40|-1.00|<0.0001
71899215|NCT01455428|143321449|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.2||0.0079|TWO_SIDED|95.0|-0.93|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.14|-0.93|0.0079
71816095|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-1.83|||<|0.001|TWO_SIDED|95.0|-2.41|-1.24|||Mixed Models Analysis|||||-1.24|-2.41|<0.001
71899216|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.172||0.0024|TWO_SIDED|95.0|-0.86|-0.19||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.19|-0.86|0.0024
71899217|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.173||0.0002|TWO_SIDED|95.0|-0.99|-0.31||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.31|-0.99|0.0002
71899218|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.173||0.0012|TWO_SIDED|95.0|-0.91|-0.22||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.22|-0.91|0.0012
71816096|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-1.63|||<|0.001|TWO_SIDED|95.0|-2.27|-0.99|||Mixed Models Analysis|||||-0.99|-2.27|<0.001
71899219|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0101|TWO_SIDED|95.0|-0.79|-0.11||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.11|-0.79|0.0101
71899220|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.0258|TWO_SIDED|95.0|-0.73|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.73|0.0258
71899221|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.175||0.026|TWO_SIDED|95.0|-0.74|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.05|-0.74|0.0260
71899222|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.175||0.0062|TWO_SIDED|95.0|-0.83|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.14|-0.83|0.0062
71899223|NCT01455428|143321450|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.176||0.0081|TWO_SIDED|95.0|-0.81|-0.12||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.||-0.12|-0.81|0.0081
71899224|NCT01455428|143321451|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||Analysis was two-sided and performed at the 0.05 significance level|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.||||0.0007
71899225|NCT01455428|143321454|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|1.932|<|0.0001|TWO_SIDED|95.0|-11.99|-4.37||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-4.37|-11.99|<0.0001
71899226|NCT01455428|143321455|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.107||0.0007|TWO_SIDED|95.0|-0.58|-0.16||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-0.16|-0.58|0.0007
71679010|NCT00459706|142875840|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
71816097|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-1.85|||<|0.001|TWO_SIDED|95.0|-2.39|-1.31|||Mixed Models Analysis|||||-1.31|-2.39|<0.001
71899227|NCT01455428|143321457|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|2.464||0.0039|TWO_SIDED|95.0|-12.08|-2.35||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||-2.35|-12.08|0.0039
71899228|NCT01455428|143321458|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.73|STANDARD_ERROR_OF_MEAN|2.783||0.5351|TWO_SIDED|95.0|-3.76|7.22||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||7.22|-3.76|0.5351
71899229|NCT01455428|143321459|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|2.579||0.8892|TWO_SIDED|95.0|-5.45|4.73||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||4.73|-5.45|0.8892
71816098|NCT04867785|143134653|SUPERIORITY||LSMean Difference|0.82|||<|0.001|TWO_SIDED|95.0|0.35|1.29|||Mixed Models Analysis|||||1.29|0.35|<0.001
71899230|NCT01455428|143321460|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.147||0.0035|TWO_SIDED|95.0|0.14|0.72||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.72|0.14|0.0035
71899231|NCT01455428|143321461|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.8||||0.0972|TWO_SIDED|95.0|0.9|3.6||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.||3.60|0.90|0.0972
71679011|NCT00459706|142875841|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
71679012|NCT00459706|142875841|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
71816099|NCT04867785|143134653|SUPERIORITY||LSMean Difference|0.06||||0.796|TWO_SIDED|95.0|-0.41|0.53|||Mixed Models Analysis|||||0.53|-0.41|0.796
71816100|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-0.14||||0.548|TWO_SIDED|95.0|-0.61|0.32|||Mixed Models Analysis|||||0.32|-0.61|0.548
71679013|NCT00459706|142875842|SUPERIORITY_OR_OTHER|||||||0.934||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group||||0.934
71679014|NCT00459706|142875842|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||0.656
71679015|NCT00459706|142875843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group||||<0.001
71848144|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|||Change at Final Week (AM)||||0.037
71848145|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||ANOVA|||Baseline (PM)||||0.146
71848146|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|||||||ANOVA|||Change at Week 1 (PM)||||0.426
71848147|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.259|||||||ANOVA|||Change at Week 2 (PM)||||0.259
71848148|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||ANOVA|||Change at Week 3 (PM)||||0.026
71848149|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||ANOVA|||Change at Week 4 (PM)||||0.022
71848150|NCT00070707|143210939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANOVA|||Change at Final Week (PM)||||0.043
71848151|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||ANOVA|||Baseline (AM)||||0.181
71848152|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
71848153|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
71848154|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANOVA|||Change at Week 3 (AM)||||0.002
71848155|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||ANOVA|||Change at Week 4 (AM)||||0.027
71848156|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.069|||||||ANOVA|||Change at Final Week (AM)||||0.069
71848157|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||ANOVA|||Baseline (PM)||||0.373
71848158|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||ANOVA|||Change at Week 1 (PM)||||0.148
71848159|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||ANOVA|||Change at Week 2 (PM)||||0.009
71679016|NCT00459706|142875843|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group||||<0.001
71679017|NCT02105246|142875867|EQUIVALENCE|This analysis compared the proportion of eligible patients who participated in cardiac rehab after referral to home-based vs. referral to center-based programs.|Risk Ratio (RR)|0.98||||0.8|TWO_SIDED||||||Chi-squared|||Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programs||||0.80
71679018|NCT02105246|142875868|NON_INFERIORITY|This analysis compared Baseline to 3-month change in 6-minute walk test distance among subjects who participated in home-based cardiac rehab vs. subjects who participated in center-based cardiac rehab|Median Difference (Final Values)|196.0|||<|0.001|TWO_SIDED|||||This comparison was unadjusted.|Wilcoxon (Mann-Whitney)|||Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||<0.001
71848160|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||ANOVA|||Change at Week 3 (PM)||||0.016
71848161|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|||||||ANOVA|||Change at Week 4 (PM)||||0.113
71848162|NCT00070707|143210940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173|||||||ANOVA|||Change at Final Week (PM)||||0.173
71848163|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.089|||||||ANOVA|||Baseline (AM)||||0.089
71848164|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)||||0.014
71848165|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)||||0.004
71848166|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)||||0.001
71848167|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|||||||ANOVA|||Change at Week 4 (AM)||||0.041
71848168|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||ANOVA|||Change at Final Week (AM)||||0.036
71848169|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|||||||ANOVA|||Baseline (PM)||||0.170
71848170|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237|||||||ANOVA|||Change at Week 1 (PM)||||0.237
71848171|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||ANOVA|||Change at Week 2 (PM)||||0.019
71848172|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||ANOVA|||Change at Week 3 (PM)||||0.018
71848173|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.149|||||||ANOVA|||Change at Week 4 (PM)||||0.149
71848174|NCT00070707|143210941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||ANOVA|||Change at Final Week (PM)||||0.231
71848175|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.745|||||||ANOVA|||Baseline (AM)||||0.745
71848176|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||ANOVA|||Change at Week 1 (AM)||||0.250
71848177|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (AM)||||||0.202|||||||ANOVA|||||||0.202
71848178|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (AM)||||||0.104|||||||ANOVA|||||||0.104
71848179|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (AM)||||||0.348|||||||ANOVA|||||||0.348
71848180|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (AM)||||||0.355|||||||ANOVA|||||||0.355
71848181|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Baseline (PM)||||||0.851|||||||ANOVA|||||||0.851
71848182|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 1 (PM)||||||0.993|||||||ANOVA|||||||0.993
71848183|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 2 (PM)||||||0.476|||||||ANOVA|||||||0.476
71848184|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 3 (PM)||||||0.149|||||||ANOVA|||||||0.149
71848185|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Week 4 (PM)||||||0.616|||||||ANOVA|||||||0.616
71848186|NCT00070707|143210942|SUPERIORITY_OR_OTHER_LEGACY|Change at Final Week (PM)||||||0.527|||||||ANOVA|||||||0.527
71848187|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|||||||ANOVA|||Baseline (AM)||||0.116
71816101|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-0.77|||<|0.001|TWO_SIDED|95.0|-1.19|-0.36|||Mixed Models Analysis|||||-0.36|-1.19|<0.001
71816102|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-0.57||||0.025|TWO_SIDED|95.0|-1.08|-0.07|||Mixed Models Analysis|||||-0.07|-1.08|0.025
71899232|NCT01455428|143321462|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|3.161||0.5702|TWO_SIDED|95.0|-4.44|8.03||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||8.03|-4.44|0.5702
71816103|NCT04867785|143134653|SUPERIORITY||LSMean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.16|-0.44|||Mixed Models Analysis|||||-0.44|-1.16|<0.001
71816104|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.14||||0.121|TWO_SIDED|95.0|-0.04|0.32|||Regression, Logistic|||||0.32|-0.04|0.121
71816105|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.36||||0.002|TWO_SIDED|95.0|0.13|0.59|||Regression, Logistic|||||0.59|0.13|0.002
71816106|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.48|||<|0.001|TWO_SIDED|95.0|0.28|0.68|||Regression, Logistic|||||0.68|0.28|<0.001
71816107|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.001|TWO_SIDED|95.0|0.53|0.87|||Regression, Logistic|||||0.87|0.53|<0.001
71816108|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.6|||<|0.001|TWO_SIDED|95.0|0.39|0.82|||Regression, Logistic|||||0.82|0.39|<0.001
71816109|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.68|||<|0.001|TWO_SIDED|95.0|0.51|0.85|||Regression, Logistic|||||0.85|0.51|<0.001
71816110|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|-0.21||||0.03|TWO_SIDED|95.0|-0.39|-0.02|||Regression, Logistic|||||-0.02|-0.39|0.030
71816111|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.01||||0.938|TWO_SIDED|95.0|-0.22|0.24|||Regression, Logistic|||||0.24|-0.22|0.938
71816112|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.13||||0.209|TWO_SIDED|95.0|-0.07|0.33|||Regression, Logistic|||||0.33|-0.07|0.209
71816113|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.35|||<|0.001|TWO_SIDED|95.0|0.18|0.53|||Regression, Logistic|||||0.53|0.18|<0.001
71816114|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.26||||0.024|TWO_SIDED|95.0|0.03|0.48|||Regression, Logistic|||||0.48|0.03|0.024
71816115|NCT04867785|143134654|SUPERIORITY||Risk Difference (RD)|0.33|||<|0.001|TWO_SIDED|95.0|0.16|0.51|||Regression, Logistic|||||0.51|0.16|<0.001
71816116|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.14||||0.169|TWO_SIDED|95.0|-0.06|0.35|||Regression, Logistic|||||0.35|-0.06|0.169
71816117|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.39||||0.001|TWO_SIDED|95.0|0.15|0.63|||Regression, Logistic|||||0.63|0.15|0.001
71816118|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.37||||0.002|TWO_SIDED|95.0|0.14|0.6|||Regression, Logistic|||||0.60|0.14|0.002
71816119|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.59|||<|0.001|TWO_SIDED|95.0|0.39|0.79|||Regression, Logistic|||||0.79|0.39|<0.001
71816120|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.56|||<|0.001|TWO_SIDED|95.0|0.34|0.78|||Regression, Logistic|||||0.78|0.34|<0.001
71816121|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.57|||<|0.001|TWO_SIDED|95.0|0.38|0.76|||Regression, Logistic|||||0.76|0.38|<0.001
71816122|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|-0.23||||0.029|TWO_SIDED|95.0|-0.44|-0.02|||Regression, Logistic|||||-0.02|-0.44|0.029
71816123|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.02||||0.898|TWO_SIDED|95.0|-0.22|0.25|||Regression, Logistic|||||0.25|-0.22|0.898
71816124|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.0||||0.968|TWO_SIDED|95.0|-0.24|0.23|||Regression, Logistic|||||0.23|-0.24|0.968
71816125|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.22||||0.033|TWO_SIDED|95.0|0.02|0.42|||Regression, Logistic|||||0.42|0.02|0.033
71816126|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.19||||0.099|TWO_SIDED|95.0|-0.04|0.41|||Regression, Logistic|||||0.41|-0.04|0.099
71816127|NCT04867785|143134655|SUPERIORITY||Risk Difference (RD)|0.2||||0.044|TWO_SIDED|95.0|0.01|0.39|||Regression, Logistic|||||0.39|0.01|0.044
71816128|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-2.12||||0.823|TWO_SIDED|95.0|-20.73|16.48|||Mixed Models Analysis|||||16.48|-20.73|0.823
71816129|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-19.6||||0.165|TWO_SIDED|95.0|-47.29|8.1|||Mixed Models Analysis|||||8.10|-47.29|0.165
71816130|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-33.3||||0.001|TWO_SIDED|95.0|-53.56|-13.04|||Mixed Models Analysis|||||-13.04|-53.56|0.001
71816131|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-55.5|||<|0.001|TWO_SIDED|95.0|-69.77|-41.22|||Mixed Models Analysis|||||-41.22|-69.77|<0.001
71816132|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-29.22||||0.015|TWO_SIDED|95.0|-52.84|-5.59|||Mixed Models Analysis|||||-5.59|-52.84|0.015
71816133|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-54.61|||<|0.001|TWO_SIDED|95.0|-69.63|-39.59|||Mixed Models Analysis|||||-39.59|-69.63|<0.001
71816134|NCT04867785|143134656|SUPERIORITY||LSMean Difference|33.54|||<|0.001|TWO_SIDED|95.0|18.26|48.82|||Mixed Models Analysis|||||48.82|18.26|<0.001
71816135|NCT04867785|143134656|SUPERIORITY||LSMean Difference|16.07||||0.231|TWO_SIDED|95.0|-10.25|42.39|||Mixed Models Analysis|||||42.39|-10.25|0.231
71816136|NCT04867785|143134656|SUPERIORITY||LSMean Difference|2.37||||0.804|TWO_SIDED|95.0|-16.28|21.01|||Mixed Models Analysis|||||21.01|-16.28|0.804
71816137|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-19.83|||<|0.001|TWO_SIDED|95.0|-31.01|-8.65|||Mixed Models Analysis|||||-8.65|-31.01|<0.001
71816138|NCT04867785|143134656|SUPERIORITY||LSMean Difference|6.45||||0.586|TWO_SIDED|95.0|-16.75|29.65|||Mixed Models Analysis|||||29.65|-16.75|0.586
71816139|NCT04867785|143134656|SUPERIORITY||LSMean Difference|-18.94||||0.002|TWO_SIDED|95.0|-30.93|-6.96|||Mixed Models Analysis|||||-6.96|-30.93|0.002
71816140|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-0.25||||0.984|TWO_SIDED|95.0|-24.57|24.07|||Mixed Models Analysis|||||24.07|-24.57|0.984
71816141|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-4.2||||0.804|TWO_SIDED|95.0|-37.44|29.03|||Mixed Models Analysis|||||29.03|-37.44|0.804
71816142|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-21.47||||0.167|TWO_SIDED|95.0|-51.91|8.98|||Mixed Models Analysis|||||8.98|-51.91|0.167
71816143|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-51.84|||<|0.001|TWO_SIDED|95.0|-76.09|-27.59|||Mixed Models Analysis|||||-27.59|-76.09|<0.001
71679019|NCT02105246|142875869|NON_INFERIORITY|This analysis compared 6-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab.|Median Difference (Final Values)|159.0||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.||||0.03
71679020|NCT04257032|142875896|OTHER||Ratio of geometric means (T/R) %|105.37|||||TWO_SIDED|90.0|97.94|113.35|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 9.9|Relative bioavailability||113.35|97.94|
71679021|NCT04257032|142875897|OTHER||Ratio of geometric means (T/R) %|114.5|||||TWO_SIDED|90.0|104.22|125.81|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 14.0|Relative bioavailability||125.81|104.22|
71679022|NCT04257032|142875898|OTHER||Ratio of geometric means (T/R) %|108.18|||||TWO_SIDED|90.0|100.26|116.73|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.3|Relative bioavailability||116.73|100.26|
71679023|NCT04257032|142875899|OTHER||Ratio of geometric means (T/R) %|108.89|||||TWO_SIDED|90.0|99.84|118.76|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 12.9|Relative bioavailability||118.76|99.84|
71816144|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-23.94||||0.168|TWO_SIDED|95.0|-57.94|10.06|||Mixed Models Analysis|||||10.06|-57.94|0.168
71816145|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-50.58|||<|0.001|TWO_SIDED|95.0|-74.94|-26.22|||Mixed Models Analysis|||||-26.22|-74.94|<0.001
71816146|NCT04867785|143134657|SUPERIORITY||LSMean Difference|10.02||||0.362|TWO_SIDED|95.0|-11.55|31.6|||Mixed Models Analysis|||||31.60|-11.55|0.362
71816147|NCT04867785|143134657|SUPERIORITY||LSMean Difference|6.07||||0.696|TWO_SIDED|95.0|-24.34|36.48|||Mixed Models Analysis|||||36.48|-24.34|0.696
71816148|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-11.19||||0.436|TWO_SIDED|95.0|-39.38|16.99|||Mixed Models Analysis|||||16.99|-39.38|0.436
71899233|NCT01455428|143321463|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.87|STANDARD_ERROR_OF_MEAN|2.194||0.6929|TWO_SIDED|95.0|-3.46|5.2||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||5.20|-3.46|0.6929
71816149|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-41.57|||<|0.001|TWO_SIDED|95.0|-62.89|-20.25|||Mixed Models Analysis|||||-20.25|-62.89|<0.001
71816150|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-13.67||||0.418|TWO_SIDED|95.0|-46.75|19.42|||Mixed Models Analysis|||||19.42|-46.75|0.418
71816151|NCT04867785|143134657|SUPERIORITY||LSMean Difference|-40.31|||<|0.001|TWO_SIDED|95.0|-60.77|-19.85|||Mixed Models Analysis|||||-19.85|-60.77|<0.001
71816152|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-0.49||||0.54|TWO_SIDED|95.0|-2.07|1.08|||Mixed Models Analysis|||||1.08|-2.07|0.540
71816153|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-4.41|||<|0.001|TWO_SIDED|95.0|-6.69|-2.13|||Mixed Models Analysis|||||-2.13|-6.69|<0.001
71816154|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-6.78|||<|0.001|TWO_SIDED|95.0|-9.47|-4.09|||Mixed Models Analysis|||||-4.09|-9.47|<0.001
71816155|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-10.13|||<|0.001|TWO_SIDED|95.0|-12.24|-8.03|||Mixed Models Analysis|||||-8.03|-12.24|<0.001
71816156|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-12.06|||<|0.001|TWO_SIDED|95.0|-15.06|-9.06|||Mixed Models Analysis|||||-9.06|-15.06|<0.001
71899234|NCT01455428|143321464|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.84|STANDARD_ERROR_OF_MEAN|1.92||0.1403|TWO_SIDED|95.0|-6.63|0.94||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.||0.94|-6.63|0.1403
71899235|NCT01455428|143321465|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-0.86|-0.39||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.39|-0.86|<0.0001
71816157|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-10.99|||<|0.001|TWO_SIDED|95.0|-13.24|-8.73|||Mixed Models Analysis|||||-8.73|-13.24|<0.001
71816158|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-1.19||||0.135|TWO_SIDED|95.0|-2.75|0.37|||Mixed Models Analysis|||||0.37|-2.75|0.135
71816159|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-5.11|||<|0.001|TWO_SIDED|95.0|-7.36|-2.86|||Mixed Models Analysis|||||-2.86|-7.36|<0.001
71816160|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-7.48|||<|0.001|TWO_SIDED|95.0|-10.19|-4.77|||Mixed Models Analysis|||||-4.77|-10.19|<0.001
71679024|NCT04257032|142875900|OTHER||Ratio of geometric means (T/R) %|104.52|||||TWO_SIDED|90.0|97.34|112.23|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 10.6|Relative bioavailability||112.23|97.34|
71816161|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-10.83|||<|0.001|TWO_SIDED|95.0|-12.89|-8.77|||Mixed Models Analysis|||||-8.77|-12.89|<0.001
71816162|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-12.76|||<|0.001|TWO_SIDED|95.0|-15.74|-9.77|||Mixed Models Analysis|||||-9.77|-15.74|<0.001
71816163|NCT04867785|143134658|SUPERIORITY||LSMean Difference|-11.69|||<|0.001|TWO_SIDED|95.0|-13.9|-9.47|||Mixed Models Analysis|||||-9.47|-13.90|<0.001
71816164|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-0.03||||0.979|TWO_SIDED|95.0|-2.18|2.12|||Mixed Models Analysis|||||2.12|-2.18|0.979
71816165|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-4.0||||0.018|TWO_SIDED|95.0|-7.32|-0.68|||Mixed Models Analysis|||||-0.68|-7.32|0.018
71816166|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-7.09|||<|0.001|TWO_SIDED|95.0|-10.46|-3.71|||Mixed Models Analysis|||||-3.71|-10.46|<0.001
71816167|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-16.74|-9.66|||Mixed Models Analysis|||||-9.66|-16.74|<0.001
71816168|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-12.84|||<|0.001|TWO_SIDED|95.0|-16.5|-9.18|||Mixed Models Analysis|||||-9.18|-16.50|<0.001
71679025|NCT04257032|142875901|OTHER||Ratio of geometric means (T/R) %|108.42|||||TWO_SIDED|90.0|100.37|117.12|||ANOVA|ANOVA model on the logarithmic scale, considering the effects 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random.|Intra-individual coefficient of variation (gCV %) = 11.5|Relative bioavailability||117.12|100.37|
71679026|NCT02091986|142875910|SUPERIORITY_OR_OTHER|||||||0.006|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.006
71679027|NCT02091986|142875910|SUPERIORITY_OR_OTHER|||||||0.063|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.063
71848188|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Week 1 (AM)||||0.994
71848189|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||ANOVA|||Change at Week 2 (AM)||||0.961
71848190|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183|||||||ANOVA|||Change at Week 3 (AM)||||0.183
71848191|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||ANOVA|||Change at Week 4 (AM)||||0.440
71848192|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.838|||||||ANOVA|||Change at Final Week (AM)||||0.838
71848193|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096|||||||ANOVA|||Baseline (PM)||||0.096
71848194|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|||||||ANOVA|||Change at Week 1 (PM)||||0.362
71848195|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Change at Week 2 (PM)||||0.693
71848196|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.603|||||||ANOVA|||Change at Week 3 (PM)||||0.603
71848197|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.579|||||||ANOVA|||Change at Week 4 (PM)||||0.579
71848198|NCT00070707|143210943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|||||||ANOVA|||Change at Final Week (PM)||||0.413
71848199|NCT00070707|143210944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
71848200|NCT00070707|143210944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744|||||||ANOVA|||Change at Day 15||||0.744
71899236|NCT01455428|143321466|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.113|<|0.0001|TWO_SIDED|95.0|-0.72|-0.27||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.||-0.27|-0.72|<0.0001
71899237|NCT01455428|143321468|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.315||0.506|TWO_SIDED|95.0|-0.83|0.41||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.41|-0.83|0.5060
71679028|NCT02091986|142875910|SUPERIORITY_OR_OTHER|||||||0.373|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.373
71679029|NCT02091986|142875911|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.001
71679030|NCT02091986|142875911|SUPERIORITY_OR_OTHER|||||||0.195|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.195
71848201|NCT00070707|143210944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.675|||||||ANOVA|||Change at Day 29||||0.675
71848202|NCT00070707|143210945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.693|||||||ANOVA|||Baseline||||0.693
71848203|NCT00070707|143210945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.818|||||||ANOVA|||Change at Day 15||||0.818
71848204|NCT00070707|143210945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.915|||||||ANOVA|||Change at Day 29||||0.915
71848205|NCT00070707|143210946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.823|||||||ANOVA|||Baseline||||0.823
71848206|NCT00070707|143210946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|||||||ANOVA|||Change at Day 15||||0.202
71848207|NCT00070707|143210946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.199|||||||ANOVA|||Change at Day 29||||0.199
71848208|NCT00070707|143210947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375|||||||ANOVA|||Baseline||||0.375
71848209|NCT00070707|143210947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||ANOVA|||Change at Week 1||||0.710
71848210|NCT00070707|143210947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.597|||||||ANOVA|||Change at Week 2||||0.597
71848211|NCT00070707|143210947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242|||||||ANOVA|||Change at Week 3||||0.242
71848212|NCT00070707|143210947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.696|||||||ANOVA|||Change at Week 4||||0.696
71848213|NCT00070707|143210947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|||||||ANOVA|||Change at Final Week||||0.670
71848214|NCT00070707|143210948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.865|||||||ANOVA|||Baseline||||0.865
71848215|NCT00070707|143210948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|||||||ANOVA|||Change at Week 1||||0.025
71848216|NCT00070707|143210948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|||||||ANOVA|||Change at Week 2||||0.288
71848217|NCT00070707|143210948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79|||||||ANOVA|||Change at Week 3||||0.790
71848218|NCT00070707|143210948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.211|||||||ANOVA|||Change at Week 4||||0.211
71848219|NCT00070707|143210948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.136|||||||ANOVA|||Change at Final Week||||0.136
71848220|NCT00070707|143210949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.667|||||||ANOVA|||Baseline||||0.667
71848221|NCT00070707|143210949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.656|||||||ANOVA|||Change at Week 1||||0.656
71848222|NCT00070707|143210949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.458|||||||ANOVA|||Change at Week 2||||0.458
71848223|NCT00070707|143210949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANOVA|||Change at Week 3||||0.220
71848224|NCT00070707|143210949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|||||||ANOVA|||Change at Week 4||||0.775
71848225|NCT00070707|143210949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.994|||||||ANOVA|||Change at Final Week||||0.994
71848226|NCT00070707|143210950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.363|||||||ANOVA|||Baseline||||0.363
71848227|NCT00070707|143210950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262|||||||ANOVA|||Change at Week 1||||0.262
71848228|NCT00070707|143210950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.386|||||||ANOVA|||Change at Week 2||||0.386
71848229|NCT00070707|143210950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|||||||ANOVA|||Change at Week 3||||0.167
71679031|NCT02091986|142875911|SUPERIORITY_OR_OTHER|||||||0.032|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.032
71679032|NCT02091986|142875912|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||<0.001
71679033|NCT02091986|142875912|SUPERIORITY_OR_OTHER|||||||0.005|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.005
71679034|NCT02091986|142875912|SUPERIORITY_OR_OTHER|||||||0.326|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.326
71679035|NCT02091986|142875913|SUPERIORITY_OR_OTHER|||||||0.276|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.276
71679036|NCT02091986|142875913|SUPERIORITY_OR_OTHER|||||||0.759|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.759
71816169|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-13.91|||<|0.001|TWO_SIDED|95.0|-17.1|-10.71|||Mixed Models Analysis|||||-10.71|-17.10|<0.001
71899238|NCT01455428|143321469|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.285||0.7247|TWO_SIDED|95.0|-0.66|0.46||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.||0.46|-0.66|0.7247
71899239|NCT03303339|143321470|OTHER||Maximum Tolerated Dose|60.0|||||TWO_SIDED|||||||||||||
71899240|NCT00477451|143321483|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.200
71679037|NCT02091986|142875913|SUPERIORITY_OR_OTHER|||||||0.165|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.165
71679038|NCT02091986|142875914|SUPERIORITY_OR_OTHER|||||||0.724|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.724
71816170|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-1.34||||0.213|TWO_SIDED|95.0|-3.45|0.77|||Mixed Models Analysis|||||0.77|-3.45|0.213
71816171|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-5.31||||0.002|TWO_SIDED|95.0|-8.66|-1.97|||Mixed Models Analysis|||||-1.97|-8.66|0.002
71816172|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-8.4|||<|0.001|TWO_SIDED|95.0|-11.76|-5.04|||Mixed Models Analysis|||||-5.04|-11.76|<0.001
71816173|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-14.51|||<|0.001|TWO_SIDED|95.0|-18.0|-11.01|||Mixed Models Analysis|||||-11.01|-18.00|<0.001
71816174|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-14.15|||<|0.001|TWO_SIDED|95.0|-17.77|-10.54|||Mixed Models Analysis|||||-10.54|-17.77|<0.001
71816175|NCT04867785|143134659|SUPERIORITY||LSMean Difference|-15.22|||<|0.001|TWO_SIDED|95.0|-18.36|-12.07|||Mixed Models Analysis|||||-12.07|-18.36|<0.001
71816176|NCT03926065|143134668|SUPERIORITY|||||||0.126|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1260
71816177|NCT03926065|143134668|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
71816178|NCT03926065|143134668|SUPERIORITY|||||||0.0992|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.0992
71816179|NCT03926065|143134669|SUPERIORITY|||||||0.5502|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.5502
71816180|NCT03926065|143134669|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0072
71816181|NCT03926065|143134670|SUPERIORITY|||||||0.103|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.1030
71816182|NCT03926065|143134670|SUPERIORITY|||||||0.0178|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||0.0178
71816183|NCT03926065|143134670|SUPERIORITY|||||||0.241|||||||Mixed Models Analysis|||Interaction between Portion Size and Palatability||||0.2410
71679039|NCT02091986|142875914|SUPERIORITY_OR_OTHER|||||||0.909|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.909
71679040|NCT02091986|142875914|SUPERIORITY_OR_OTHER|||||||0.811|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.811
71679041|NCT02091986|142875915|SUPERIORITY_OR_OTHER|||||||0.134|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.134
71679042|NCT02091986|142875915|SUPERIORITY_OR_OTHER|||||||0.985|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.985
71679043|NCT02091986|142875915|SUPERIORITY_OR_OTHER|||||||0.128|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.128
71679044|NCT02091986|142875916|SUPERIORITY_OR_OTHER|||||||0.684|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.684
71816184|NCT03926065|143134671|SUPERIORITY|||||||0.0012|||||||Mixed Models Analysis|||Standard Palatability (Standard Portion Size and Larger Portion Size) compared to Enhanced Palatability (Standard Portion Size and Larger Portion Size)||||0.0012
71816185|NCT03926065|143134671|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Standard Portion Size (Standard Palatability and Enhanced Palatability) compared to Larger Portion Size (Standard Palatability and Enhanced Palatability)||||<0.0001
71679045|NCT02091986|142875916|SUPERIORITY_OR_OTHER|||||||0.621|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.621
71848230|NCT00070707|143210950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.505|||||||ANOVA|||Change at Week 4||||0.505
71848231|NCT00070707|143210950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.725|||||||ANOVA|||Change at Final Week||||0.725
71848232|NCT00070707|143210951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.954|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 15||||0.954
71848233|NCT00070707|143210951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 29||||0.295
71848234|NCT00070707|143210952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 15||||0.268
71848235|NCT00070707|143210952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 29||||0.154
71848236|NCT00308308|143210963|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52-week data, resulting in \> 90% power for a non-inferiority test of the difference in 12-month change of HbA1c scores between treatment groups with non-inferiority margin of 0.4%, standard deviation of 1.2 and 1-sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|95.0|0.08|0.4|||ANCOVA|||||0.40|0.08|
71848237|NCT00308308|143210964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|-2.7|-1.0|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate||-1.0|-2.7|<0.0001
71848238|NCT00308308|143210965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.9|STANDARD_ERROR_OF_MEAN|7.41||0.0052|TWO_SIDED|95.0|-35.4|-6.3|||ANCOVA|||||-6.3|-35.4|0.0052
71899241|NCT00477451|143321484|SUPERIORITY|||||||0.368|||||||Wilcoxon (Mann-Whitney)|||||||0.368
71899242|NCT00477451|143321485|SUPERIORITY|||||||0.207|||||||t-test, 2 sided|||||||0.207
71899243|NCT00257192|143321492|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.8|STANDARD_ERROR_OF_MEAN|1.26||0.153|TWO_SIDED|95.0|-4.28|0.67||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).||Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (\<) 0.0124) or for futility (2-sided p-value greater than (\>) 0.4772; The final analysis is to employ a 2-sided p-value \<0.0462.||0.67|-4.28|0.1530
71899244|NCT00257192|143321493|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.21|STANDARD_ERROR_OF_MEAN|0.14||0.1289|TWO_SIDED|95.0|-0.48|0.06||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Difference from placebo||0.06|-0.48|0.1289
71899245|NCT00257192|143321494|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-2.57|STANDARD_ERROR_OF_MEAN|2.0||0.1987||95.0|-6.5|1.36||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Total score: difference from placebo||1.36|-6.50|0.1987
71899246|NCT00257192|143321495|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-1.33|STANDARD_ERROR_OF_MEAN|0.65||0.0412|TWO_SIDED|95.0|-2.61|-0.05||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Positive score: difference from placebo||-0.05|-2.61|0.0412
71848239|NCT00308308|143210966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.941||||0.8311|TWO_SIDED|95.0|0.536|1.652|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model||1.652|0.536|0.8311
71848240|NCT00308308|143210967|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0124|TWO_SIDED|95.0|0.278|0.856|||Regression, Logistic||Model: Treatment + Site|||0.856|0.278|0.0124
71848241|NCT00308308|143210968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.825||||0.2786|TWO_SIDED|95.0|0.582|1.169|||Regression, Logistic||Model: Treatment + Site|||1.169|0.582|0.2786
71848242|NCT00308308|143210969|SUPERIORITY_OR_OTHER|||||||0.1193|||||||Generalized Estimation Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.1193
71848243|NCT00308308|143210970|SUPERIORITY_OR_OTHER|||||||0.2131|||||||Generalized Estimating Equation|"* Based on Poisson distribution~* Model: Treatment + Time Period"||||||0.2131
71899247|NCT00257192|143321495|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.43|STANDARD_ERROR_OF_MEAN|0.58||0.4661|TWO_SIDED|95.0|-1.57|0.72||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Negative score: difference from placebo||0.72|-1.57|0.4661
71679046|NCT02091986|142875916|SUPERIORITY_OR_OTHER|||||||0.929|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.929
71679047|NCT02091986|142875917|SUPERIORITY_OR_OTHER|||||||0.664|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.664
71848244|NCT01802333|143210971|OTHER|||||||0.84|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.84
71848245|NCT01802333|143210971|OTHER|||||||0.42|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.||||0.42
71679048|NCT02091986|142875917|SUPERIORITY_OR_OTHER|||||||0.747|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.747
71679049|NCT02091986|142875917|SUPERIORITY_OR_OTHER|||||||0.913|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.913
71679050|NCT02091986|142875918|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.015
71679051|NCT02091986|142875918|SUPERIORITY_OR_OTHER|||||||0.342|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.342
71679052|NCT02091986|142875918|SUPERIORITY_OR_OTHER|||||||0.138|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.||||||0.138
71679053|NCT02091986|142875922|SUPERIORITY_OR_OTHER|||||||0.098|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.098
71679054|NCT02091986|142875922|SUPERIORITY_OR_OTHER|||||||0.367|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.367
71679055|NCT02091986|142875922|SUPERIORITY_OR_OTHER|||||||0.449|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group||||||0.449
71679056|NCT00794040|142875940|SUPERIORITY||Odds Ratio (OR)|11.7||||0.006|TWO_SIDED|95.0|2.0|68.16||priori threshold p\<0.05|Multilevel growth curve model|||||68.16|2.00|0.006
71679057|NCT00794040|142875941|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.085|TWO_SIDED|95.0|-1.32|0.09||priori threshold \<0.05|Multilevel growth curve model|||||0.09|-1.32|0.085
71679058|NCT00794040|142875942|SUPERIORITY||Mean Difference (Final Values)|4.72||||0.124|TWO_SIDED|95.0|-1.3|10.74||priori threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||10.74|-1.30|0.124
71679059|NCT00794040|142875943|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.993|TWO_SIDED|95.0|-4.76|4.8||priori threshold p\<0.05|Multilevel growth curve model|||||4.80|-4.76|0.993
71848246|NCT01802333|143210972|OTHER||||||<|0.0001|||||||Exact binomial test, 1-sided|||||||<0.0001
71679060|NCT00794040|142875944|SUPERIORITY||Mean Difference (Final Values)|1.02||||0.598|TWO_SIDED|95.0|-4.23|2.19||priori threshold p\<0.05|Multilevel growth curve model|||||2.19|-4.23|0.598
71679061|NCT02396420|142875945|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71848247|NCT01802333|143210974|OTHER|||||||0.52|||||||Regression, Cox|Adjusted for: Age (\< 40 vs. \>= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).||||0.52
71679062|NCT02396420|142875946|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679063|NCT02396420|142875947|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679064|NCT02396420|142875948|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
71679065|NCT02396420|142875949|OTHER|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|||
71679066|NCT02396420|142875950|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679067|NCT02396420|142875951|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679068|NCT02396420|142875952|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679069|NCT02396420|142875953|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679070|NCT02396420|142875954|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679071|NCT02396420|142875955|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679072|NCT02396420|142875956|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679073|NCT02396420|142875957|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679074|NCT02396420|142875958|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679075|NCT02396420|142875959|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679076|NCT02396420|142875960|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679077|NCT02396420|142875961|OTHER||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.|||
71679078|NCT01273623|142875962|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71848248|NCT01947491|143210982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71899248|NCT00257192|143321496|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|-0.19|STANDARD_ERROR_OF_MEAN|0.14||0.182|TWO_SIDED|95.0|-0.47|0.09||Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.|ANOVA|||Difference from placebo||0.09|-0.47|0.1820
71899249|NCT00257192|143321504|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean|1.34|STANDARD_ERROR_OF_MEAN|1.19||0.2613|TWO_SIDED|95.0|-1.01|3.69||SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.|ANCOVA|Observed cases at Week 6.||Neurocognitive Index score at Week 6: difference from placebo||3.69|-1.01|0.2613
71899250|NCT00570739|143321511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0123|TWO_SIDED|95.0|-0.27|-0.03||P-Value is for the LS mean difference between treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||-0.03|-0.27|0.0123
71899251|NCT00570739|143321511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0201|TWO_SIDED|95.0|-0.33|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-0.03|-0.33|0.0201
71899252|NCT00570739|143321511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0239|TWO_SIDED|95.0|-0.36|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.03|-0.36|0.0239
71899253|NCT00570739|143321511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0046|TWO_SIDED|95.0|-0.42|-0.08||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||-0.08|-0.42|0.0046
71899254|NCT00570739|143321512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.1112|TWO_SIDED|95.0|-11.3|1.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 Weeks||1.2|-11.3|0.1112
71899255|NCT00570739|143321512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.2167|TWO_SIDED|95.0|-8.6|2.0|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||2.0|-8.6|0.2167
71899256|NCT00570739|143321512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.7269|TWO_SIDED|95.0|-7.0|4.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||4.9|-7.0|0.7269
71899257|NCT00570739|143321512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.4063|TWO_SIDED|95.0|-8.4|3.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.4|-8.4|0.4063
71899258|NCT00570739|143321512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.4909|TWO_SIDED|95.0|-8.0|3.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||3.9|-8.0|0.4909
71899259|NCT00570739|143321513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.303||||0.7606|TWO_SIDED|95.0|-2.259|1.653||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks||1.653|-2.259|0.7606
71899260|NCT00570739|143321513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.015||||0.1782|TWO_SIDED|95.0|-2.477|0.447||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||0.447|-2.477|0.1782
71899261|NCT00570739|143321513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.504||||0.0332|TWO_SIDED|95.0|-2.887|-0.121||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks||-0.121|-2.887|0.0332
71899262|NCT00570739|143321513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176||||0.861|TWO_SIDED|95.0|-1.805|2.158||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||2.158|-1.805|0.8610
71899263|NCT00570739|143321513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.8196|TWO_SIDED|95.0|-1.599|2.019||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||2.019|-1.599|0.8196
71899264|NCT00570739|143321514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153||||0.1078|TWO_SIDED|95.0|-0.34|0.034||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||0.034|-0.340|0.1078
71899265|NCT00570739|143321514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141||||0.1146|TWO_SIDED|95.0|-0.317|0.035||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)||0.035|-0.317|0.1146
71899266|NCT00570739|143321515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9933|TWO_SIDED|95.0|-9.3|9.4||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks||9.4|-9.3|0.9933
71899267|NCT00570739|143321515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.8203|TWO_SIDED|95.0|-10.5|8.3||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks LOCF||8.3|-10.5|0.8203
71899268|NCT00570739|143321516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.195|TWO_SIDED|95.0|-17.5|3.6||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks||3.6|-17.5|0.1950
71899269|NCT00570739|143321516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.7||||0.1583|TWO_SIDED|95.0|-18.3|3.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||3.0|-18.3|0.1583
71679079|NCT04064411|142875965|NON_INFERIORITY|"Noninferiority margin = 2.0% for abaloparatide-sMTS compared with abaloparatide-SC.~Non-inferiority was to be concluded if the lower bound of the 2-sided 95% confidence interval (CI) for the estimated treatment difference (abaloparatide-sMTS minus abaloparatide-SC) in the percent change from baseline in lumbar spine BMD at 12 months was above -2.0% using a Mixed Model for Repeated Measures (MMRM) analysis."|Least Squares Means (LSM) Difference|-3.721|||||TWO_SIDED|95.0|-5.0089|-2.4331|||||LSM Difference = abaloparatide-sMTS minus abaloparatide-SC|||-2.4331|-5.0089|
71816186|NCT03239873|143134675|NON_INFERIORITY|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|TWO_SIDED|95.0|-2.7|2.8|||Miettinen and Nurminen|||||2.8|-2.7|<0.001
71816187|NCT03239873|143134675|OTHER|Acceptability|Antibody Response Rate|98.4|||<|0.001|TWO_SIDED|95.0|95.9|99.6|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being \>76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).||99.6|95.9|<0.001
71816188|NCT03239873|143134676|NON_INFERIORITY|The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio \[VARIVAX® PE34 process/VARIVAX® 2016 commercial product\] being \>0.67.|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||Miettinen and Nurminen|||||1.1|0.9|<0.001
71816189|NCT03239873|143134677|OTHER||Difference in Percentage|2.0||||0.436|TWO_SIDED|95.0|-3.1|7.1|||Miettinen & Nurminen|||Up to 42 days after Vaccination 1||7.1|-3.1|0.436
71816190|NCT03239873|143134677|OTHER||Difference in Percentage|2.9||||0.204|TWO_SIDED|95.0|-1.6|7.5|||Miettinen & Nurminen|||Up to 42 days after Vaccination 2||7.5|-1.6|0.204
71816191|NCT03239873|143134678|OTHER||Difference in Percentage|-1.3||||0.102|TWO_SIDED|95.0|-3.5|0.4|||Miettinen & Nurminen|||Measles-like rash||0.4|-3.5|0.102
71816192|NCT03239873|143134678|OTHER||Difference in Percentage|0.3||||0.317|TWO_SIDED|95.0|-0.9|1.9|||Miettinen & Nurminen|||Rubella-like rash||1.9|-0.9|0.317
71816193|NCT03239873|143134678|OTHER||Difference in Percentage|1.3||||0.241||95.0|-1.0|4.0|||Miettinen & Nurminen|||Varicella-like rash||4.0|-1.0|0.241
71816194|NCT03239873|143134678|OTHER||Difference in Percentage|-0.3||||0.318|TWO_SIDED|95.0|-1.9|0.9|||Miettinen & Nurminen|||Zoster-like rash||0.9|-1.9|0.318
71848249|NCT03137784|143210991|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.089|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
71848250|NCT03137784|143210991|OTHER||Linear Mixed Model (LMM)|0.09|||<|0.001|TWO_SIDED|95.0|0.047|0.132|||Linear Mixed Model|||||0.132|0.047|<0.001
71848251|NCT03137784|143210992|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.165|||<|0.001|TWO_SIDED|95.0|0.127|0.203|||Linear Mixed Model|||||0.203|0.127|<0.001
71848252|NCT03137784|143210992|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.168|||<|0.001|TWO_SIDED|95.0|0.129|0.206|||Linear Mixed Model|||||0.206|0.129|<0.001
71848253|NCT03137784|143210993|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.176|||<|0.001|TWO_SIDED|95.0|0.141|0.212|||Linear Mixed Model|||||0.212|0.141|<0.001
71848254|NCT03137784|143210993|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.179|||<|0.001|TWO_SIDED|95.0|0.144|0.215|||Linear Mixed Model|||||0.215|0.144|<0.001
71848255|NCT03137784|143210994|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.139|||<|0.001|TWO_SIDED|95.0|0.106|0.173|||Linear Mixed Model|||||0.173|0.106|<0.001
71848256|NCT03137784|143210994|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.146|||<|0.001|TWO_SIDED|95.0|0.112|0.179|||Linear Mixed Model|||||0.179|0.112|<0.001
71848257|NCT03137784|143210995|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.164|||<|0.001|TWO_SIDED|95.0|0.127|0.201|||Linear Mixed Model|||||0.201|0.127|<0.001
71848258|NCT03137784|143210995|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.174|||<|0.001|TWO_SIDED|95.0|0.137|0.211|||Linear Mixed Model|||||0.211|0.137|<0.001
71848259|NCT03137784|143210996|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.036||||0.079|TWO_SIDED|95.0|-0.004|0.077|||Linear Mixed Model|||||0.077|-0.004|0.079
71848260|NCT03137784|143210996|OTHER|Treatment difference|Linear Mixed Model (LMM)|0.058||||0.006|TWO_SIDED|95.0|0.017|0.099|||Linear Mixed Model|||||0.099|0.017|0.006
71848261|NCT03137784|143210998|OTHER|Treatment difference|Linear Mixed Model (LMM)|25.51|||<|0.001|TWO_SIDED|95.0|19.22|31.79|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||31.79|19.22|<0.001
71848262|NCT03137784|143210998|OTHER|Treatment difference|Linear Mixed Model (LMM)|24.29|||<|0.001|TWO_SIDED|95.0|17.99|30.59|||Linear Mixed Model|||||30.59|17.99|<0.001
71899270|NCT00570739|143321517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.3663|TWO_SIDED|95.0|-16.1|6.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.0|-16.1|0.3663
71848263|NCT03137784|143210999|OTHER|Treatment difference|Linear Mixed Model (LMM)|30.95|||<|0.001|TWO_SIDED|95.0|25.07|36.82|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||36.82|25.07|<0.001
71848264|NCT03137784|143210999|OTHER|Treatment difference|Linear Mixed Model (LMM)|29.37|||<|0.001|TWO_SIDED|95.0|23.47|35.26|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|||35.26|23.47|<0.001
71848265|NCT03137784|143211000|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Linear Mixed Model|||||0.00|-0.31|0.053
71848266|NCT03137784|143211000|OTHER|Treatment difference|Linear Mixed Model (LMM)|-0.11||||0.163|TWO_SIDED|95.0|-0.27|0.05|||Linear Mixed Model|||||0.05|-0.27|0.163
71848267|NCT02736188|143211002|SUPERIORITY||LS Mean Difference|0.8||||0.4287|TWO_SIDED|95.0|-1.17|2.77||Baseline is fit into the model as a covariate.|generalized estimating equation (GEE)|||Week 8||2.77|-1.17|0.4287
71848268|NCT02736188|143211002|SUPERIORITY||LS Mean Difference|0.36||||0.7031|TWO_SIDED|95.0|-1.49|2.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.21|-1.49|0.7031
71816195|NCT03239873|143134679|OTHER||Difference in Percentage|1.1||||0.17|TWO_SIDED|95.0|-0.7|3.4|||Miettinen & Nurminen|||Measles-like rash||3.4|-0.7|0.170
71816196|NCT03239873|143134679|OTHER||Difference in Percentage|-0.3||||0.576|TWO_SIDED|95.0|-2.2|1.4|||Miettinen & Nurminen|||Varicella-like rash||1.4|-2.2|0.576
71816197|NCT03239873|143134679|OTHER||Difference in Percentage|0.4||||0.312|TWO_SIDED|95.0|-1.0|2.0|||Miettinen & Nurminen|||Zoster-like rash||2.0|-1.0|0.312
71816198|NCT03239873|143134680|OTHER||Difference of Percentage|-1.0||||0.696|TWO_SIDED|95.0|-5.9|4.0|||Miettinen & Nurminen|||Injection site erythema||4.0|-5.9|0.696
71816199|NCT03239873|143134680|OTHER||Difference in Percentage|0.7||||0.796|TWO_SIDED|95.0|-4.7|6.2|||Miettinen & Nurminen|||Injection site pain||6.2|-4.7|0.796
71816200|NCT03239873|143134680|OTHER||Difference in Percentage|-2.7||||0.111||95.0|-6.2|0.7|||Miettinen & Nurminen|||Injection site swelling||0.7|-6.2|0.111
71816201|NCT03239873|143134681|OTHER||Difference in Percentage|-0.3||||0.931|TWO_SIDED|95.0|-6.9|6.4|||Miettinen & Nurminen|||Injection site erythema||6.4|-6.9|0.931
71816202|NCT03239873|143134681|OTHER||Difference in Percentage|-1.6||||0.523|TWO_SIDED|95.0|-6.6|3.4|||Miettinen & Nurminen|||Injection site pain||3.4|-6.6|0.523
71816203|NCT03239873|143134681|OTHER||Difference in Percentage|2.0||||0.415|TWO_SIDED|95.0|-2.9|6.9|||Miettinen & Nurminen|||Injection site swelling||6.9|-2.9|0.415
71816204|NCT03239873|143134682|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-3.4|6.7|||||Miettinen \& Nurminen|||6.7|-3.4|
71816205|NCT03239873|143134683|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Miettinen \& Nurminen|||2.6|-2.5|
71899271|NCT00570739|143321517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.2524|TWO_SIDED|95.0|-17.9|4.7||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.7|-17.9|0.2524
71899272|NCT00570739|143321518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.051||||0.8158|TWO_SIDED|95.0|-7.828|9.929||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||9.929|-7.828|0.8158
71899273|NCT00570739|143321518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.565||||0.7433|TWO_SIDED|95.0|-10.966|7.836||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.836|-10.966|0.7433
71899274|NCT00570739|143321519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215||||0.5161|TWO_SIDED|95.0|-0.437|0.867||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||0.867|-0.437|0.5161
71816206|NCT03239873|143134684|OTHER||Difference in Percentage|1.9|||||TWO_SIDED|95.0|-6.1|9.8|||||Miettinen \& Nurminen|||9.8|-6.1|
71816207|NCT03239873|143134685|OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-4.7|9.2|||||Miettinen \& Nurminen|||9.2|-4.7|
71816208|NCT03239873|143134690|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
71816209|NCT03239873|143134691|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Miettinen \& Nurminen|||1.3|-1.3|
71816210|NCT03239873|143134694|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-4.6|10.3|||||Miettinen and Nurminen|||10.3|-4.6|
71816211|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Univariate analysis.||||||0.0000
71816212|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.1038|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Multivariate analysis (6 main effects only).||||||0.1038
71816213|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.0588|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Univariate analysis.||||||0.0588
71816214|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.4802|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Multivariate analysis (6 main effects only).||||||0.4802
71816215|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.0147|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.0147
71816216|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.1181|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).||||||0.1181
71816217|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Univariate analysis.||||||0.0000
71816218|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Multivariate analysis (6 main effects only).||||||0.0006
71816219|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Univariate analysis.||||||0.0004
71848269|NCT02736188|143211002|SUPERIORITY||LS Mean Difference|-0.91||||0.4253|TWO_SIDED|95.0|-3.14|1.32||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.32|-3.14|0.4253
71848270|NCT02736188|143211002|SUPERIORITY||LS Mean Difference|-0.06||||0.9747|TWO_SIDED|95.0|-3.49|3.38||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.38|-3.49|0.9747
71848271|NCT02736188|143211003|SUPERIORITY||LS Mean Difference|-0.27||||0.4721|TWO_SIDED|95.0|-1.01|0.47||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.47|-1.01|0.4721
71848272|NCT02736188|143211003|SUPERIORITY||LS Mean Difference|-0.19||||0.6611|TWO_SIDED|95.0|-1.02|0.64||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.64|-1.02|0.6611
71848273|NCT02736188|143211003|SUPERIORITY||LS Mean Difference|-0.44||||0.276|TWO_SIDED|95.0|-1.22|0.35|||GEE model|Baseline is fit into the model as a covariate.||Week 24||0.35|-1.22|0.2760
71848274|NCT02736188|143211003|SUPERIORITY||LS Mean Difference|-0.28||||0.6977|TWO_SIDED|95.0|-1.69|1.13||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.13|-1.69|0.6977
71848275|NCT02736188|143211004|SUPERIORITY||Difference in LS Means|0.7||||0.0648|TWO_SIDED|95.0|-0.04|1.45||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.45|-0.04|0.0648
71848276|NCT02736188|143211004|SUPERIORITY||difference in LS means|0.74||||0.0692|TWO_SIDED|95.0|-0.06|1.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.55|-0.06|0.0692
71848277|NCT02736188|143211004|SUPERIORITY||difference in LS means|0.44||||0.4317|TWO_SIDED|95.0|-0.65|1.52||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.52|-0.65|0.4317
71848278|NCT02736188|143211004|SUPERIORITY||difference in LS means|-0.34||||0.6416|TWO_SIDED|95.0|-1.78|1.1||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.10|-1.78|0.6416
71848279|NCT02736188|143211005|SUPERIORITY||difference in LS means|0.78||||0.6546|TWO_SIDED|95.0|-2.65|4.22||Baseline is fit into the model as a covariate.|GEE model|||Week 8||4.22|-2.65|0.6546
71848280|NCT02736188|143211005|SUPERIORITY||difference in LS means|-0.64||||0.7054|TWO_SIDED|95.0|-3.97|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.69|-3.97|0.7054
71848281|NCT02736188|143211005|SUPERIORITY||difference in LS means|-0.5||||0.8441|TWO_SIDED|95.0|-5.45|4.45||Baseline is fit into the model as a covariate.|GEE model|||Week 24||4.45|-5.45|0.8441
71848282|NCT02736188|143211005|SUPERIORITY||difference in LS means|4.15||||0.0864|TWO_SIDED|95.0|-0.59|8.9||Baseline is fit into the model as a covariate.|GEE model|||Week 48||8.90|-0.59|0.0864
71848283|NCT02736188|143211006|SUPERIORITY||difference in LS means|0.06||||0.8603|TWO_SIDED|95.0|-0.65|0.78||Baseline is fit into the model as a covariate.|GEE model|||Week 8||0.78|-0.65|0.8603
71899275|NCT00570739|143321519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8319|TWO_SIDED|95.0|-0.581|0.722||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||0.722|-0.581|0.8319
71899276|NCT00570739|143321520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.19|||<|0.0001|TWO_SIDED|95.0|-22.61|-13.76|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-13.76|-22.61|<0.0001
71816220|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.3371|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Multivariate analysis (6 main effects only).||||||0.3371
71816221|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Univariate analysis.||||||0.0000
71816222|NCT01250119|143134707|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Multivariate analysis (6 main effects only).||||||0.0001
71816223|NCT02670538|143134716|SUPERIORITY||Least Squares (LS) Mean Difference|-2.5||||0.0417|TWO_SIDED|95.0|-4.6|-0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.4|-4.6|0.0417
71816224|NCT02670538|143134716|SUPERIORITY||LS Mean Difference|-1.8||||0.1051|TWO_SIDED|95.0|-3.9|0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.4|-3.9|0.1051
71816225|NCT02670538|143134717|SUPERIORITY||LS Mean Difference|-0.3||||0.0417|TWO_SIDED|95.0|-0.6|-0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||-0.1|-0.6|0.0417
71816226|NCT02670538|143134717|SUPERIORITY||LS Mean Difference|-0.2||||0.137|TWO_SIDED|95.0|-0.4|0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test|||||0.1|-0.4|0.1370
71816227|NCT02887989|143134721|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||.6570
71816228|NCT02887989|143134722|SUPERIORITY|||||||0.6339|||||||t-test, 2 sided|||||||.6339
71816229|NCT00708526|143134727|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|A Bonferroni correction was used.||We compared times for discharge criteria after general anesthesia with and without the QED.||||>0.05
71816230|NCT00708526|143134728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||t-test, 2 sided|||The effect of the use of hypercapnia and increased ventilation on the time to recovery events was compared using multivariate analysis of variance with the Hotelling's two sample T2.-test and the two-tailed unpaired t-test; individual comparisons were by Bonferroni adjusted two tailed unpaired t-tests. The data was tested for normality before identifying statistical significance.||||0.039
71816231|NCT02674490|143134760|SUPERIORITY|||||||0.54||||||Threshold for significance is two-sided alpha of 0.05.|Regression, Linear|The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age.||Sample Size Determination If sample size in each group is 20, we will have 89% power to detect a difference in means of 23 (the difference between A-tDCS mean change in accuracy of 33 and a sham mean change in accuracy of 10) assuming that the SD of change for both groups is 22.2 using a two group t-test with a two-sided alpha of 0.05.||||0.54
71816232|NCT01872910|143134828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.0|||||TWO_SIDED|95.0|-2.1|20.0|||||95% CrI is reported here, not the CI.|||20.0|-2.1|
71816233|NCT01872910|143134828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-34.6|||||TWO_SIDED|95.0|-45.7|-23.2|||||95% CrI is reported here, not the CI.|||-23.2|-45.7|
71816234|NCT01872910|143134828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.6|||||TWO_SIDED|95.0|32.7|54.9|||||95% CrI is reported here, not the CI.|||54.9|32.7|
71816235|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.9|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||0.2|-2.9|
71816236|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|2.9|6.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||6.0|2.9|
71816237|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-7.4|-4.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||-4.3|-7.4|
71816238|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-5.2|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||0.2|-5.2|
71816239|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|4.4|9.8|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||9.8|4.4|
71816240|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|||||TWO_SIDED|95.0|-12.2|-6.9|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||-6.9|-12.2|
71816241|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||||TWO_SIDED|95.0|-7.9|-0.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-0.1|-7.9|
71816242|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|||||TWO_SIDED|95.0|5.3|13.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||13.0|5.3|
71816243|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-16.9|-9.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||-9.3|-16.9|
71816244|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|||||TWO_SIDED|95.0|-13.2|0.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||0.5|-13.2|
71816245|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|||||TWO_SIDED|95.0|6.6|19.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||19.2|6.6|
71816246|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.7|||||TWO_SIDED|95.0|-25.9|-13.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||-13.5|-25.9|
71816247|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.3|||||TWO_SIDED|95.0|-30.8|-2.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-2.0|-30.8|
71848284|NCT02736188|143211006|SUPERIORITY||difference in LS means|-0.18||||0.6154|TWO_SIDED|95.0|-0.86|0.51||Baseline is fit into the model as a covariate.|GEE model|||Week 16||0.51|-0.86|0.6154
71848285|NCT02736188|143211006|SUPERIORITY||difference in LS means|0.47||||0.1999|TWO_SIDED|95.0|-0.25|1.2||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.20|-0.25|0.1999
71848286|NCT02736188|143211006|SUPERIORITY||difference in LS means|-0.03||||0.9568|TWO_SIDED|95.0|-1.25|1.18||Baseline is fit into the model as a covariate.|GEE model|||Week 48||1.18|-1.25|0.9568
71848287|NCT02736188|143211007|SUPERIORITY||difference in LS means|0.45||||0.5447|TWO_SIDED|95.0|-1.0|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.90|-1.00|0.5447
71899277|NCT00570739|143321520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.08|||<|0.0001|TWO_SIDED|95.0|-22.09|-12.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-12.08|-22.09|<0.0001
71899278|NCT00570739|143321520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.33|||<|0.0001|TWO_SIDED|95.0|-20.96|-11.69|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-11.69|-20.96|<0.0001
71816248|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.0|37.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||37.2|9.0|
71816249|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-39.4|||||TWO_SIDED|95.0|-53.2|-25.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||-25.3|-53.2|
71899279|NCT00570739|143321521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.0001|TWO_SIDED|95.0|-15.99|-8.81|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.81|-15.99|<0.0001
71899280|NCT00570739|143321521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.28|||<|0.0001|TWO_SIDED|95.0|-13.23|-5.34|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.34|-13.23|<0.0001
71899281|NCT00570739|143321521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||<|0.0001|TWO_SIDED|95.0|-11.98|-4.67|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Week LOCF||-4.67|-11.98|<0.0001
71816250|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.5|1.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.|||1.6|-1.5|
71816251|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-2.9|2.4|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.|||2.4|-2.9|
71816252|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-4.7|3.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.|||3.1|-4.7|
71816253|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-8.3|4.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.|||4.1|-8.3|
71816254|NCT01872910|143134829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|||||TWO_SIDED|95.0|-21.4|7.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.|||7.6|-21.4|
71816255|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3|||||TWO_SIDED|95.0|-4.2|14.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||14.5|-4.2|
71816256|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.0|||||TWO_SIDED|95.0|-41.5|-22.4|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||-22.4|-41.5|
71816257|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|27.8|46.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||46.5|27.8|
71848288|NCT02736188|143211007|SUPERIORITY||difference in LS means|-0.56||||0.5051|TWO_SIDED|95.0|-2.22|1.09||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.09|-2.22|0.5051
71848289|NCT02736188|143211007|SUPERIORITY||difference in LS means|0.27||||0.7478|TWO_SIDED|95.0|-1.36|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 24||1.90|-1.36|0.7478
71848290|NCT02736188|143211007|SUPERIORITY||difference in LS means|-0.41||||0.7429|TWO_SIDED|95.0|-2.86|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 48||2.04|-2.86|0.7429
71848291|NCT02736188|143211008|SUPERIORITY||difference in LS means|2.0||||0.6434|TWO_SIDED|95.0|-6.48|10.49||Baseline is fit into the model as a covariate.|GEE model|||Week 8||10.49|-6.48|0.6434
71848292|NCT02736188|143211008|SUPERIORITY||difference in LS means|-1.99||||0.7118|TWO_SIDED|95.0|-12.53|8.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16||8.55|-12.53|0.7118
71848293|NCT02736188|143211008|SUPERIORITY||difference in LS means|4.15||||0.4399|TWO_SIDED|95.0|-6.39|14.69||Baseline is fit into the model as a covariate.|GEE model|||Week 24||14.69|-6.39|0.4399
71899282|NCT00570739|143321522|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.63||||0.2026|TWO_SIDED|95.0|-1.43|6.7|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||6.70|-1.43|0.2026
71899283|NCT00570739|143321522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.4506|TWO_SIDED|95.0|-2.12|4.75|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||4.75|-2.12|0.4506
71848294|NCT02736188|143211008|SUPERIORITY||difference in LS means|7.98||||0.443|TWO_SIDED|95.0|-12.41|28.37||Baseline is fit into the model as a covariate.|GEE model|||Week 48||28.37|-12.41|0.4430
71848295|NCT02736188|143211009|SUPERIORITY||difference in LS means|0.28||||0.6428|TWO_SIDED|95.0|-0.9|1.46||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.46|-0.90|0.6428
71848296|NCT02736188|143211009|SUPERIORITY||difference in LS means|-0.25||||0.7334|TWO_SIDED|95.0|-1.72|1.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.21|-1.72|0.7334
71848297|NCT02736188|143211009|SUPERIORITY||difference in LS means|0.58||||0.4409|TWO_SIDED|95.0|-0.89|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.04|-0.89|0.4409
71848298|NCT02736188|143211009|SUPERIORITY||difference in LS means|0.99||||0.4687|TWO_SIDED|95.0|-1.69|3.68||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.68|-1.69|0.4687
71848299|NCT02736188|143211010|SUPERIORITY||difference in LS means|1.14||||0.1502|TWO_SIDED|95.0|-0.41|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 8||2.69|-0.41|0.1502
71848300|NCT02736188|143211010|SUPERIORITY||difference in LS means|-0.2||||0.8188|TWO_SIDED|-1.89|-1.89|1.49||Baseline is fit into the model as a covariate.|GEE model|||Week 16||1.49|-1.89|0.8188
71848301|NCT02736188|143211010|SUPERIORITY||difference in LS means|0.8||||0.5122|TWO_SIDED|95.0|-1.58|3.17||Baseline is fit into the model as a covariate.|GEE model|||Week 24||3.17|-1.58|0.5122
71848302|NCT02736188|143211010|SUPERIORITY||difference in LS means|0.72||||0.7022|TWO_SIDED|95.0|-2.96|4.4||Baseline is fit into the model as a covariate.|GEE model|||Week 48||4.40|-2.96|0.7022
71848303|NCT02736188|143211011|SUPERIORITY||difference in LS means|0.19||||0.7906|TWO_SIDED|95.0|-1.22|1.6||Baseline is fit into the model as a covariate.|GEE model|||Week 8||1.60|-1.22|0.7906
71848304|NCT02736188|143211011|SUPERIORITY||difference in LS means|0.66||||0.3531|TWO_SIDED|95.0|-0.74|2.07||Baseline is fit into the model as a covariate.|GEE model|||Week 16||2.07|-0.74|0.3531
71848305|NCT02736188|143211011|SUPERIORITY||difference in LS means|0.15||||0.8846|TWO_SIDED|95.0|-1.92|2.23||Baseline is fit into the model as a covariate.|GEE model|||Week 24||2.23|-1.92|0.8846
71848306|NCT02736188|143211011|SUPERIORITY||difference in LS means|2.08||||0.0168|TWO_SIDED|95.0|0.38|3.79||Baseline is fit into the model as a covariate.|GEE model|||Week 48||3.79|0.38|0.0168
71848307|NCT00240994|143211012|SUPERIORITY_OR_OTHER||Proportion with graft loss or death|0.057|||||TWO_SIDED|95.0|0.007|0.192|||95% Confidence Interval|95% CI using an exact binomial method||The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.||0.192|0.007|
71848308|NCT00854594|143211024|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: pre-intervention efficacies will be equal in the two study arms.||||0.26
71848309|NCT00854594|143211025|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: post-intervention efficacies will be equal in the two study arms.||||0.74
71899284|NCT00570739|143321522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81||||0.2609|TWO_SIDED|95.0|-1.35|4.97|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||4.97|-1.35|0.2609
71899285|NCT00570739|143321523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.81|||<|0.0001|TWO_SIDED|95.0|-11.53|-6.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-6.08|-11.53|<0.0001
71848310|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.72|||||TWO_SIDED|95.0|-0.33|1.77||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.77|-0.33|
71848311|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.46|||||TWO_SIDED|95.0|-0.5|1.43||||||Period AC: Difference varenicline versus placebo.||1.43|-0.50|
71848312|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.92|||||TWO_SIDED|95.0|-0.27|2.11||||||Period AD: Difference varenicline versus placebo.||2.11|-0.27|
71848313|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.52|1.53||||||Period AE: Difference varenicline versus placebo.||1.53|-0.52|
71848314|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.35|0.5|||||Mixed Models Analysis|Period BC: Difference varenicline versus placebo.||0.50|-1.35|
71848315|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-1.18|1.24||||||Period BD: Difference varenicline versus placebo.||1.24|-1.18|
71848316|NCT00749944|143211033|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.37|||||TWO_SIDED|95.0|-1.37|0.63|||||Mixed Models Analysis|Period BE: Difference varenicline versus placebo.||0.63|-1.37|
71848317|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|-0.15|1.39||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.39|-0.15|
71848318|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-0.24|1.07||||||Period AC: Difference varenicline versus placebo.||1.07|-0.24|
71848319|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.26|1.22||||||Period AD: Difference varenicline versus placebo.||1.22|-0.26|
71848320|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.18|1.06||||||Period AE: Difference varenicline versus placebo.||1.06|-0.18|
71848321|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.58|0.78||||||Period BC: Difference varenicline versus placebo.||0.78|-0.58|
71848322|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.48|0.92||||||Period BD: Difference varenicline versus placebo.||0.92|-0.48|
71848323|NCT00749944|143211034|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.26|0.72||||||Period BE: Difference varenicline versus placebo.||0.72|-0.26|
71816258|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3|||||TWO_SIDED|95.0|-2.9|17.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||17.6|-2.9|
71816259|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.1|||||TWO_SIDED|95.0|-45.6|-24.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||-24.6|-45.6|
71816260|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.5|||||TWO_SIDED|95.0|32.1|52.7|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||52.7|32.1|
71816261|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|||||TWO_SIDED|95.0|-1.0|23.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||23.0|-1.0|
71816262|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.7|||||TWO_SIDED|95.0|-45.1|-20.3|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||-20.3|-45.1|
71816263|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|43.5|||||TWO_SIDED|95.0|31.3|55.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||55.5|31.3|
71816264|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.4|||||TWO_SIDED|95.0|-1.6|26.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||26.2|-1.6|
71816265|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.2|||||TWO_SIDED|95.0|-44.0|-16.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||-16.0|-44.0|
71816266|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|42.6|||||TWO_SIDED|95.0|28.6|56.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||56.5|28.6|
71816267|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-9.7|12.9|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.|||12.9|-9.7|
71816268|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-9.8|16.8|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.|||16.8|-9.8|
71816269|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.5|||||TWO_SIDED|95.0|-9.9|19.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h.|||19.0|-9.9|
71816270|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-9.2|21.1|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.|||21.1|-9.2|
71816271|NCT01872910|143134830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-8.4|24.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.|||24.2|-8.4|
71816272|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.6|1.9|||||95% CrI is reported here, not the CI. Estimation is SPID 0 to 4 h.|||1.9|-0.6|
71816273|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|||||TWO_SIDED|95.0|-4.1|-1.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||-1.7|-4.1|
71816274|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.3|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||4.8|2.3|
71816275|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.9|3.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||3.2|-0.9|
71816276|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8|||||TWO_SIDED|95.0|-6.8|-2.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||-2.7|-6.8|
71816277|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|3.8|8.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||8.0|3.8|
71816278|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-1.0|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||4.8|-1.0|
71816279|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||||TWO_SIDED|95.0|-9.0|-3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||-3.3|-9.0|
71816280|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||||TWO_SIDED|95.0|5.1|10.9|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||10.9|5.1|
71816281|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-1.3|8.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||8.1|-1.3|
71816282|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2|||||TWO_SIDED|95.0|-12.9|-3.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||-3.5|-12.9|
71816283|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|7.0|16.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||16.5|7.0|
71816284|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-2.6|18.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||18.3|-2.6|
71816285|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|||||TWO_SIDED|95.0|-24.7|-3.6|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||-3.6|-24.7|
71816286|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|11.5|32.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||32.2|11.5|
71816287|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.6|1.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.|||1.0|-1.6|
71816288|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.2|2.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.|||2.1|-2.2|
71816289|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-2.9|3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.|||3.3|-2.9|
71816290|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-3.9|5.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.|||5.7|-3.9|
71848324|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.62|||||TWO_SIDED|95.0|0.0|1.24||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.24|-0.00|
71848325|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.73|||||TWO_SIDED|95.0|0.18|1.29||||||Period AC: Difference varenicline versus placebo.||1.29|0.18|
71848326|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.66|||||TWO_SIDED|95.0|0.02|1.3||||||Period AD: Difference varenicline versus placebo.||1.30|0.02|
71848327|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.43|||||TWO_SIDED|95.0|-0.19|1.05||||||Period AE: Difference varenicline versus placebo.||1.05|-0.19|
71848328|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.48|||||TWO_SIDED|95.0|-0.09|1.05||||||Period BC: Difference varenicline versus placebo.||1.05|-0.09|
71848329|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.39|||||TWO_SIDED|95.0|-0.28|1.06||||||Period BD: Difference varenicline versus placebo.||1.06|-0.28|
71848330|NCT00749944|143211035|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.47|0.65||||||Period BE: Difference varenicline versus placebo.||0.65|-0.47|
71848331|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|-0.02|1.72|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.72|-0.02|
71848332|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.85|||||TWO_SIDED|95.0|0.16|1.54|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.54|0.16|
71848333|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.24|||||TWO_SIDED|95.0|0.39|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||2.08|0.39|
71848334|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.83|||||TWO_SIDED|95.0|0.14|1.52|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.52|0.14|
71816291|NCT01872910|143134831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-6.8|15.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.|||15.0|-6.8|
71816292|NCT01872910|143134832|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.85|||||TWO_SIDED|95.0|0.99|3.46|||||Hazard ratio (HR) of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.46|0.99|
71848335|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.06|1.09|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.09|-0.06|
71848336|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.88|||||TWO_SIDED|95.0|0.05|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||1.70|0.05|
71848337|NCT00749944|143211036|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.38|||||TWO_SIDED|95.0|-0.12|0.88|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.88|-0.12|
71848338|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.82|||||TWO_SIDED|95.0|-3.07|1.43|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.43|-3.07|
71848339|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-2.47|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||2.08|-2.47|
71848340|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-2.15|||||TWO_SIDED|95.0|-5.19|0.89|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.89|-5.19|
71848341|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.98|||||TWO_SIDED|95.0|-3.67|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||1.70|-3.67|
71848342|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.95|||||TWO_SIDED|95.0|-0.36|4.26|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||4.26|-0.36|
71848343|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-3.32|3.3|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||3.30|-3.32|
71848344|NCT00749944|143211037|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.09|||||TWO_SIDED|95.0|-1.8|3.97|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||3.97|-1.80|
71816293|NCT01872910|143134832|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.34|||||TWO_SIDED|95.0|0.16|0.72|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.72|0.16|
71816294|NCT01872910|143134832|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|5.48|||||TWO_SIDED|95.0|2.69|11.16|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||11.16|2.69|
71679080|NCT01970475|142875976|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).|Risk Ratio (RR)|1.039|||||TWO_SIDED|90.0|0.954|1.133|||||Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.|The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.||1.133|0.954|
71816295|NCT01872910|143134832|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.57|2.59|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||2.59|0.57|
71816296|NCT01872910|143134833|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.78|||||TWO_SIDED|95.0|0.41|1.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||1.47|0.41|
71816297|NCT01872910|143134833|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|2.15|||||TWO_SIDED|95.0|1.19|3.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||3.88|1.19|
71816298|NCT01872910|143134833|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.36|||||TWO_SIDED|95.0|0.19|0.67|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.67|0.19|
71848345|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.52|||||TWO_SIDED|95.0|-0.29|1.32|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.32|-0.29|
71848346|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.54|||||TWO_SIDED|95.0|-0.17|1.25|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||1.25|-0.17|
71848347|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.18|||||TWO_SIDED|95.0|-0.55|0.92|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.92|-0.55|
71848348|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.26|||||TWO_SIDED|95.0|-0.46|0.99|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.99|-0.46|
71848349|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.59|||||TWO_SIDED|95.0|-0.19|1.37|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||1.37|-0.19|
71816299|NCT01872910|143134834|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.33|||||TWO_SIDED|95.0|0.12|0.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.88|0.12|
71848350|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.76|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.76|-0.91|
71848351|NCT00749944|143211038|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.65|0.85|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.85|-0.65|
71848352|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.23|||||TWO_SIDED|95.0|-0.2|0.65|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.65|-0.20|
71848353|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.17|0.58|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.||0.58|-0.17|
71816300|NCT01872910|143134834|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|4.16|||||TWO_SIDED|95.0|2.04|8.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||8.47|2.04|
71816301|NCT01872910|143134834|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.08|||||TWO_SIDED|95.0|0.03|0.21|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.|||0.21|0.03|
71816302|NCT03469349|143134847|SUPERIORITY||Least square mean difference|29.19|STANDARD_ERROR_OF_MEAN|10.083||0.0041|TWO_SIDED|95.0|9.35|49.02|||MMRM|||Least squares means, p-values were obtained using a mixed model for repeated measures (MMRM) analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||49.02|9.35|0.0041
71816303|NCT03469349|143134848|SUPERIORITY||Least square mean difference|15.86|STANDARD_ERROR_OF_MEAN|7.814||0.0431|TWO_SIDED|95.0|0.49|31.24|||MMRM|||Week 2: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||31.24|0.49|0.0431
71899286|NCT00570739|143321523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.0001|TWO_SIDED|95.0|-10.23|-3.66|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-3.66|-10.23|<0.0001
71899287|NCT00570739|143321523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.09||||0.0001|TWO_SIDED|95.0|-9.14|-3.05|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-3.05|-9.14|0.0001
71816304|NCT03469349|143134848|SUPERIORITY||Least square mean difference|35.51|STANDARD_ERROR_OF_MEAN|12.48||0.0047|TWO_SIDED|95.0|10.96|60.05|||MMRM|||Week 24: Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||60.05|10.96|0.0047
71899288|NCT00570739|143321524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05||||0.0171|TWO_SIDED|95.0|-0.33|13.99||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 8 weeks||13.99|-0.33|0.0171
71899289|NCT00570739|143321524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.71|||<|0.0001|TWO_SIDED|95.0|9.66|25.54||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks||25.54|9.66|<0.0001
71899290|NCT00570739|143321524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|||<|0.0001|TWO_SIDED|95.0|11.18|25.74||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks LOCF||25.74|11.18|<0.0001
71899291|NCT00570739|143321525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.81||||0.0496|TWO_SIDED|95.0|0.0|5.62|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks||5.62|0.0|0.0496
71899292|NCT00570739|143321525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.0117|TWO_SIDED|95.0|0.82|6.47|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||6.47|0.82|0.0117
71899293|NCT00570739|143321525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43||||0.0009|TWO_SIDED|95.0|1.83|7.03|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.03|1.83|0.0009
71899294|NCT00570739|143321526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.56|||<|0.0001|TWO_SIDED|95.0|-14.74|-8.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||-8.38|-14.74|<0.0001
71899295|NCT00570739|143321526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.53||||0.0001|TWO_SIDED|95.0|-13.14|-5.92|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||-5.92|-13.14|0.0001
71899296|NCT00570739|143321526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.59|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||-4.59|-11.35|<0.0001
71899297|NCT00570739|143321527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.57||||0.0003|TWO_SIDED|95.0|5.76|19.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks||19.38|5.76|0.0003
71899298|NCT00570739|143321527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.52||||0.0003|TWO_SIDED|95.0|6.64|22.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks||22.40|6.64|0.0003
71899299|NCT00570739|143321527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.08|||<|0.0001|TWO_SIDED|95.0|7.95|22.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||22.20|7.95|<0.0001
71679081|NCT02100670|142876011|SUPERIORITY_OR_OTHER||Difference of LS mean|-9.23||||0.4144|TWO_SIDED|95.0|-31.45|12.98||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||12.98|-31.45|0.4144
71679082|NCT02100670|142876012|SUPERIORITY_OR_OTHER||LS mean difference|1.58||||0.8761|TWO_SIDED|95.0|-18.34|21.5||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||21.50|-18.34|0.8761
71848354|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.21|||||TWO_SIDED|95.0|-0.23|0.65|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.||0.65|-0.23|
71848355|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.37|0.41|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.||0.41|-0.37|
71848356|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-0.41|0.59|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.||0.59|-0.41|
71848357|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.44|0.63|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.||0.63|-0.44|
71848358|NCT00749944|143211039|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.12|||||TWO_SIDED|95.0|-0.58|0.34|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.||0.34|-0.58|
71848359|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.22|||||TWO_SIDED|95.0|-0.66|1.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.10|-0.66|
71848360|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.44|||||TWO_SIDED|95.0|-0.46|1.35|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.35|-0.46|
71848361|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.22|||||TWO_SIDED|95.0|-1.16|0.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.71|-1.16|
71848362|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.68|0.73|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.73|-0.68|
71848363|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.58|||||TWO_SIDED|95.0|-0.79|1.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.96|-0.79|
71848364|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.69|0.82|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.82|-1.69|
71848365|NCT00749944|143211040|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.09|||||TWO_SIDED|95.0|-0.86|0.68|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.68|-0.86|
71848366|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.27|||||TWO_SIDED|95.0|-0.55|1.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.08|-0.55|
71848367|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.53|||||TWO_SIDED|95.0|-0.39|1.46|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.46|-0.39|
71848368|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.09|||||TWO_SIDED|95.0|-1.08|1.25|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||1.25|-1.08|
71848369|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.14|||||TWO_SIDED|95.0|-0.62|0.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.90|-0.62|
71848370|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-0.94|1.95|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||1.95|-0.94|
71848371|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-1.57|1.51|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.51|-1.57|
71848372|NCT00749944|143211041|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.91|0.75|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.75|-0.91|
71848373|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.35|||||TWO_SIDED|95.0|-1.76|1.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.06|-1.76|
71848374|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.11|||||TWO_SIDED|95.0|-0.96|1.17|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.17|-0.96|
71899300|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.84||||0.0363|TWO_SIDED|95.0|0.44|13.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||13.24|0.44|0.0363
71899301|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39||||0.0347|TWO_SIDED|95.0|0.46|12.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles||12.31|0.46|0.0347
71899302|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.0028|TWO_SIDED|95.0|0.8|3.81||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.81|0.80|0.0028
71899303|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.001|TWO_SIDED|95.0|0.96|3.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles||3.73|0.96|0.0010
71899304|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0006|TWO_SIDED|95.0|3.1|11.21||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||11.21|3.10|0.0006
71899305|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.13||||0.0003|TWO_SIDED|95.0|3.35|10.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles||10.91|3.35|0.0003
71899306|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.88||||0.175|TWO_SIDED|95.0|-7.04|1.29||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||1.29|-7.04|0.1750
71899307|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23||||0.1007|TWO_SIDED|95.0|-7.1|0.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||0.63|-7.10|0.1007
71899308|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-199.3|||<|0.0001|TWO_SIDED|95.0|-272.9|-125.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-125.8|-272.9|<0.0001
71899309|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-186.1||||0.0001|TWO_SIDED|95.0|-255.9|-116.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-116.3|-255.9|0.0001
71899310|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7||||0.0466|TWO_SIDED|95.0|-23.3|-0.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||-0.2|-23.3|0.0466
71899311|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.7||||0.057|TWO_SIDED|95.0|-21.8|0.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles||0.3|-21.8|0.0570
71899312|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.7||||0.0004|TWO_SIDED|95.0|-120.3|-35.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-35.0|-120.3|0.0004
71899313|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-69.3||||0.0007|TWO_SIDED|95.0|-109.2|-29.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||-29.3|-109.2|0.0007
71899314|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.9||||0.0124|TWO_SIDED|95.0|-195.8|-23.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-23.9|-195.8|0.0124
71899315|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-106.8||||0.0098|TWO_SIDED|95.0|-187.6|-26.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||-26.0|-187.6|0.0098
71899316|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.102|TWO_SIDED|95.0|-35.6|3.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.2|-35.6|0.1020
71899317|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4||||0.0997|TWO_SIDED|95.0|-33.8|3.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||3.0|-33.8|0.0997
71816305|NCT03469349|143134849|SUPERIORITY|||||||0.0227|||||||MMRM|||Week 2: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0227
71816306|NCT03469349|143134849|SUPERIORITY|||||||0.0007|||||||MMRM|||Week 12: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0007
71816307|NCT03469349|143134849|SUPERIORITY|||||||0.0023|||||||MMRM|||Week 24: p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0023
71816308|NCT03469349|143134850|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9592||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 12||||0.9592
71816309|NCT03469349|143134850|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.5823||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||Week 24||||0.5823
71816310|NCT03469349|143134851|NON_INFERIORITY|As the sample size was too small, clinically significant difference in actovegin and placebo could not be defined, the non-inferiority margin was defined as priori based on clinical reasoning.||||||0.9424||||||p-values were obtained using logistic regression adjusting for treatment.|Regression, Logistic|||||||0.9424
71816311|NCT03469349|143134852|SUPERIORITY|||||||0.3758|||||||MMRM|||Physical Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.3758
71816312|NCT03469349|143134852|SUPERIORITY|||||||0.1412|||||||MMRM|||Physical Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1412
71816313|NCT03469349|143134852|SUPERIORITY|||||||0.1009|||||||MMRM|||Mental Health Score: Week 12; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.1009
71848375|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.49|||||TWO_SIDED|95.0|-1.94|4.91|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||4.91|-1.94|
71816314|NCT03469349|143134852|SUPERIORITY|||||||0.0015|||||||MMRM|||Mental Health Score: Week 24; Least squares means, p-values were obtained using a MMRM analysis of covariance with treatment, center, sex, age group, smoking status, diabetic status, visit and treatment-by-visit interaction as fixed effects and baseline value as covariate.||||0.0015
71816315|NCT01678820|143134853|SUPERIORITY_OR_OTHER||Difference in least squares means|0.19||||0.267|TWO_SIDED|95.0|-0.14|0.52|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment||||0.52|-0.14|0.267
71816316|NCT01678820|143134854|SUPERIORITY_OR_OTHER||Difference in percents|-0.4|||||TWO_SIDED|95.0|-10.2|9.3|||||Based on Miettinen \& Nurminen method|||9.3|-10.2|
71816317|NCT01678820|143134854|SUPERIORITY_OR_OTHER||Difference in percents|-4.3|||||TWO_SIDED|95.0|-14.7|5.8|||||Based on Miettinen \& Nurminen method|||5.8|-14.7|
71848376|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.5|||||TWO_SIDED|95.0|-1.18|2.18|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.18|-1.18|
71816318|NCT01678820|143134856|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.95|-0.28|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-0.28|-0.95|<0.001
71816319|NCT01678820|143134857|SUPERIORITY_OR_OTHER||Difference in least squares means|1.7||||0.856|TWO_SIDED|95.0|-17.1|20.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||20.6|-17.1|0.856
71816320|NCT01678820|143134857|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.2||||0.002|TWO_SIDED|95.0|-47.9|-10.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-10.6|-47.9|0.002
71816321|NCT01678820|143134858|SUPERIORITY_OR_OTHER||Difference in least squares means|-25.6|||<|0.001|TWO_SIDED|95.0|-35.6|-15.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-15.6|-35.6|<0.001
71816322|NCT01678820|143134858|SUPERIORITY_OR_OTHER||Difference in least squares means|5.3||||0.286|TWO_SIDED|95.0|-4.5|15.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||15.2|-4.5|0.286
71816323|NCT01678820|143134859|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.1|||<|0.001|TWO_SIDED|95.0|-24.2|-12.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.0|-24.2|<0.001
71816324|NCT01678820|143134859|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0||||0.99|TWO_SIDED|95.0|-6.0|6.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||6.0|-6.0|0.990
71816325|NCT01678820|143134860|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.2|||<|0.001|TWO_SIDED|95.0|-28.3|-12.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-12.2|-28.3|<0.001
71848377|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.61|||||TWO_SIDED|95.0|-0.85|2.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||2.07|-0.85|
71848378|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|2.1|||||TWO_SIDED|95.0|-2.6|6.79|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||6.79|-2.60|
71816326|NCT01678820|143134860|SUPERIORITY_OR_OTHER||Difference in least squares means|2.9||||0.469|TWO_SIDED|95.0|-5.0|10.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||10.7|-5.0|0.469
71848379|NCT00749944|143211042|SUPERIORITY_OR_OTHER||Difference (change from baseline)|1.13|||||TWO_SIDED|95.0|-0.7|2.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||2.96|-0.70|
71848380|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.26|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.27|-0.26|
71848381|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.25|0.29|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.29|-0.25|
71848382|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.1|||||TWO_SIDED|95.0|-0.37|0.58|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.58|-0.37|
71848383|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.17|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.34|-0.17|
71848384|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.04|||||TWO_SIDED|95.0|-0.4|0.48|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.48|-0.40|
71848385|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.17|||||TWO_SIDED|95.0|-0.44|0.78|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.78|-0.44|
71848386|NCT00749944|143211043|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.13|||||TWO_SIDED|95.0|-0.14|0.4|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.40|-0.14|
71848387|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.41|||||TWO_SIDED|95.0|-1.09|1.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||1.90|-1.09|
71848388|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-1.54|1.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||1.71|-1.54|
71848389|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|-2.47|2.6|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||2.60|-2.47|
71848390|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.29|||||TWO_SIDED|95.0|-1.57|2.15|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||2.15|-1.57|
71848391|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.94|||||TWO_SIDED|95.0|-2.23|0.36|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.36|-2.23|
71848392|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.74|||||TWO_SIDED|95.0|-2.81|1.33|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||1.33|-2.81|
71899318|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.7||||0.0069|TWO_SIDED|95.0|-161.6|-25.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-25.9|-161.6|0.0069
71899319|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-91.4||||0.0052|TWO_SIDED|95.0|-155.2|-27.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||-27.5|-155.2|0.0052
71816327|NCT01678820|143134861|SUPERIORITY_OR_OTHER||Difference in least squares means|-24.4|||<|0.001|TWO_SIDED|95.0|-32.6|-16.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-16.3|-32.6|<0.001
71816328|NCT01678820|143134861|SUPERIORITY_OR_OTHER||Difference in least squares means|0.3||||0.937|TWO_SIDED|95.0|-7.7|8.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||8.3|-7.7|0.937
71816329|NCT01678820|143134862|SUPERIORITY_OR_OTHER||Difference in estimated means|-15.5||||0.068|TWO_SIDED|95.0|-32.2|1.2|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||1.2|-32.2|0.068
71816330|NCT01678820|143134862|SUPERIORITY_OR_OTHER||Difference in estimated means|-10.3||||0.365|TWO_SIDED|95.0|-33.6|13.0|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.||||13.0|-33.6|0.365
71899320|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94||||0.0524|TWO_SIDED|95.0|-0.01|1.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.90|-0.01|0.0524
71899321|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.0301|TWO_SIDED|95.0|0.1|1.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.91|0.10|0.0301
71899322|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.0416|TWO_SIDED|95.0|0.02|0.89||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.89|0.02|0.0416
71899323|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46||||0.0333|TWO_SIDED|95.0|0.04|0.88||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||0.88|0.04|0.0333
71899324|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69||||0.0693|TWO_SIDED|95.0|-0.05|1.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.44|-0.05|0.0693
71899325|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.0187|TWO_SIDED|95.0|0.14|1.56||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.56|0.14|0.0187
71899326|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.5765|TWO_SIDED|95.0|-1.34|0.75||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.75|-1.34|0.5765
71899327|NCT00570739|143321528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.4762|TWO_SIDED|95.0|-1.35|0.63||P-Value is for the LS Mean Difference between treatment group|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.63|-1.35|0.4762
71899328|NCT00570739|143321529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21||||0.0652|TWO_SIDED|95.0|-0.14|4.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.57|-0.14|0.0652
71899329|NCT00570739|143321529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74||||0.0137|TWO_SIDED|95.0|0.57|4.92||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||4.92|0.57|0.0137
71848393|NCT00749944|143211046|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.43|||||TWO_SIDED|95.0|-1.78|0.92|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.92|-1.78|
71848394|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.08|||||TWO_SIDED|95.0|-0.04|0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.19|-0.04|
71848395|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.11|
71848396|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.02|||||TWO_SIDED|95.0|-0.06|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.09|-0.06|
71848397|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.02|-0.11|
71848398|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.14|||||TWO_SIDED|95.0|-0.27|-0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.01|-0.27|
71848399|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.21|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.01|-0.21|
71848400|NCT00749944|143211047|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.1|||||TWO_SIDED|95.0|-0.17|-0.03|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||-0.03|-0.17|
71848401|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.03|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.12|-0.03|
71848402|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.0|||||TWO_SIDED|95.0|-0.08|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.09|-0.08|
71899330|NCT00570739|143321529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.4726|TWO_SIDED|95.0|-0.2|0.09||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotien Particles||0.09|-0.20|0.4726
71899331|NCT00570739|143321529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.5715|TWO_SIDED|95.0|-0.17|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.10|-0.17|0.5715
71899332|NCT00570739|143321529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.0083|TWO_SIDED|95.0|0.02|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.02|0.0083
71899333|NCT00570739|143321529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0022|TWO_SIDED|95.0|0.03|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.15|0.03|0.0022
71899334|NCT00570739|143321530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.0||||0.0036|TWO_SIDED|95.0|8.6|43.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||43.5|8.6|0.0036
71899335|NCT00570739|143321530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.2||||0.001|TWO_SIDED|95.0|11.2|43.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||43.3|11.2|0.0010
71899336|NCT00570739|143321531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.8||||0.0008|TWO_SIDED|95.0|12.5|47.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||47.0|12.5|0.0008
71899337|NCT00570739|143321531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.7||||0.0002|TWO_SIDED|95.0|14.9|46.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||46.6|14.9|0.0002
71899338|NCT00570739|143321532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0033|TWO_SIDED|95.0|0.9|4.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.3|0.9|0.0033
71899339|NCT00570739|143321532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.0008|TWO_SIDED|95.0|1.2|4.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.4|1.2|0.0008
71899340|NCT00570739|143321533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0035|TWO_SIDED|95.0|-0.44|-0.09||P-Value is for the LS mean difference between the treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-0.09|-0.44|0.0035
71899341|NCT00570739|143321534|SUPERIORITY_OR_OTHER|||||||0.5848||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 4 Weeks||||0.5848
71899342|NCT00570739|143321534|SUPERIORITY_OR_OTHER|||||||0.8147||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 weeks||||0.8147
71899343|NCT00570739|143321534|SUPERIORITY_OR_OTHER|||||||0.4957||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.4957
71899344|NCT00570739|143321534|SUPERIORITY_OR_OTHER|||||||0.0467||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0467
71848403|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.03|||||TWO_SIDED|95.0|-0.04|0.11|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.11|-0.04|
71899345|NCT00570739|143321534|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 16 Weeks LOCF||||0.0589
71848404|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.08|0.05|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.05|-0.08|
71899346|NCT00570739|143321534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.0049|TWO_SIDED|95.0|1.38|6.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||6.10|1.38|0.0049
71899347|NCT00570739|143321534|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.44||||0.0092|TWO_SIDED|95.0|1.25|4.76|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.76|1.25|0.0092
71899348|NCT00570739|143321535|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Startified by country||Baseline to 4 Weeks||||0.0008
71848405|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.22|0.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.06|-0.22|
71899349|NCT00570739|143321535|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0280
71899350|NCT00570739|143321535|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks||||0.0414
71899351|NCT00570739|143321535|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0840
71899352|NCT00570739|143321535|SUPERIORITY_OR_OTHER|||||||0.0589||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0589
71899353|NCT00570739|143321535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0095|TWO_SIDED|95.0|1.21|3.96|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||3.96|1.21|0.0095
71848406|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.03|||||TWO_SIDED|95.0|-0.14|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.09|-0.14|
71848407|NCT00749944|143211048|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.11|
71848408|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.06|||||TWO_SIDED|95.0|-0.2|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.09|-0.20|
71848409|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.15|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.12|-0.15|
71848410|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.15|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.04|-0.15|
71848411|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.08|||||TWO_SIDED|95.0|-0.2|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.20|
71848412|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.17|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.27|-0.17|
71848413|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.21|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.21|
71848414|NCT00749944|143211049|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.05|||||TWO_SIDED|95.0|-0.17|0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.07|-0.17|
71848415|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.3|||||TWO_SIDED|95.0|-0.58|-0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||-0.02|-0.58|
71848416|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.44|||||TWO_SIDED|95.0|-0.69|-0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||-0.19|-0.69|
71848417|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.14|||||TWO_SIDED|95.0|-0.47|0.2|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.20|-0.47|
71848418|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.35|||||TWO_SIDED|95.0|-0.61|-0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||-0.09|-0.61|
71848419|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.45|||||TWO_SIDED|95.0|-0.83|-0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||-0.07|-0.83|
71848420|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.08|||||TWO_SIDED|95.0|-0.5|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.34|-0.50|
71848421|NCT00749944|143211050|SUPERIORITY_OR_OTHER||Difference (change from baseline|-0.27|||||TWO_SIDED|95.0|-0.57|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.02|-0.57|
71848422|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.08|-0.12|
71848423|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.08|-0.12|
71848424|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.05|||||TWO_SIDED|95.0|-0.04|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.14|-0.04|
71848425|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.07|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.04|-0.07|
71679083|NCT02100670|142876012|SUPERIORITY_OR_OTHER||LS mean difference|2.61||||0.8164|TWO_SIDED|95.0|-19.46|24.67||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||24.67|-19.46|0.8164
71848426|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.01|||||TWO_SIDED|95.0|-0.15|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.13|-0.15|
71848427|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.06|||||TWO_SIDED|95.0|0.01|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|0.01|
71848428|NCT00749944|143211051|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||0.04|-0.08|
71848429|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|0.12|||||TWO_SIDED|95.0|-0.05|0.28|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.||0.28|-0.05|
71848430|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.02|||||TWO_SIDED|95.0|-0.19|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.||0.14|-0.19|
71848431|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.29|0.22|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.||0.22|-0.29|
71848432|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.04|||||TWO_SIDED|95.0|-0.2|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.||0.13|-0.20|
71848433|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.19|||||TWO_SIDED|95.0|-0.4|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.||0.01|-0.40|
71848434|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.16|||||TWO_SIDED|95.0|-0.42|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.||0.10|-0.42|
71848435|NCT00749944|143211052|SUPERIORITY_OR_OTHER||Difference (change from baseline)|-0.07|||||TWO_SIDED|95.0|-0.22|8.0|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.||008|-0.22|
71848436|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.6|3.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.3|0.6|
71848437|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
71848438|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.1|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.1|0.4|
71848439|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
71848440|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
71848441|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
71848442|NCT00749944|143211053|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.4|0.3|
71848443|NCT00749944|143211054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.6|10.4|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||10.4|0.6|
71848444|NCT00749944|143211054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.7|11.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||11.8|0.7|
71848445|NCT00749944|143211054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
71848446|NCT00749944|143211054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.4|7.8|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||7.8|0.4|
71679084|NCT02100670|142876012|SUPERIORITY_OR_OTHER||LS mean difference|1.03||||0.9279|TWO_SIDED|95.0|-21.27|23.33||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||23.33|-21.27|0.9279
71679085|NCT02100670|142876012|SUPERIORITY_OR_OTHER||LS mean difference|-10.81||||0.3442|TWO_SIDED|95.0|-33.26|11.64||P-value from multiple comparisons using t-test in Proc Mixed.|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.|||11.64|-33.26|0.3442
71679086|NCT02100670|142876017|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.1||||0.5404|TWO_SIDED|95.0|0.81|1.48||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.48|0.81|0.5404
71679087|NCT02100670|142876017|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.9||||0.4639|TWO_SIDED|95.0|0.67|1.2||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.20|0.67|0.4639
71679088|NCT02100670|142876017|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.09||||0.5118|TWO_SIDED|95.0|0.84|1.43||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.84|0.5118
71848447|NCT00749944|143211054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2|||||TWO_SIDED|95.0|0.5|9.2|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||9.2|0.5|
71679089|NCT02100670|142876018|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|0.93||||0.6918|TWO_SIDED|95.0|0.67|1.31||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.31|0.67|0.6918
71679090|NCT02100670|142876018|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.23||||0.2389|TWO_SIDED|95.0|0.87|1.73||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.73|0.87|0.2389
71848448|NCT00749944|143211054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.4|3.2|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.2|0.4|
71848449|NCT00749944|143211055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.9|0.5|
71848450|NCT00749944|143211055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|0.7|5.3|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.7|
71679091|NCT02100670|142876018|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.0||||0.9817|TWO_SIDED|95.0|0.74|1.37||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||1.37|0.74|0.9817
71848451|NCT00749944|143211055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|0.7|4.4|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.4|0.7|
71848452|NCT00749944|143211055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|5.0|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.0|0.5|
71848453|NCT00749944|143211055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||||TWO_SIDED|95.0|0.8|6.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||6.8|0.8|
71679092|NCT02100670|142876019|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.06||||0.7003|TWO_SIDED|95.0|0.79|1.43||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.43|0.79|0.7003
71679093|NCT02100670|142876019|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.01||||0.9565|TWO_SIDED|95.0|0.75|1.35||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.35|0.75|0.9565
71899354|NCT00570739|143321535|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.0088|TWO_SIDED|95.0|1.2|3.6|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.60|1.20|0.0088
71899355|NCT00570739|143321536|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||<0.0001
71899356|NCT00570739|143321536|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||<0.0001
71899357|NCT00570739|143321536|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||<0.0001
71899358|NCT00570739|143321536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.59|||<|0.0001|TWO_SIDED|95.0|2.78|11.23|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||11.23|2.78|<0.0001
71899359|NCT00570739|143321536|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.53|9.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.10|2.53|<0.0001
71899360|NCT00570739|143321537|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks||||0.0004
71899361|NCT00570739|143321537|SUPERIORITY_OR_OTHER|||||||0.0326||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks||||0.0326
71899362|NCT00570739|143321537|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF||||0.0157
71899363|NCT00570739|143321537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.087|TWO_SIDED|95.0|0.88|7.07|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||7.07|0.88|0.0870
71899364|NCT00570739|143321537|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86||||0.00439|TWO_SIDED|95.0|1.03|7.94|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF||7.94|1.03|0.00439
71899365|NCT00570739|143321538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7959|TWO_SIDED|95.0|-1.32|1.72||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.72|-1.32|0.7959
71899366|NCT00570739|143321538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.8371|TWO_SIDED|95.0|-1.28|1.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.57|-1.28|0.8371
71899367|NCT00570739|143321539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0033||||0.4584|TWO_SIDED|95.0|-0.0122|0.0055||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0055|-0.0122|0.4584
71899368|NCT00570739|143321539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0035||||0.4039|TWO_SIDED|95.0|-0.0118|0.0048||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0048|-0.0118|0.4039
71899369|NCT00570739|143321540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.59|||<|0.0001|TWO_SIDED|95.0|-21.07|-10.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate.||||-10.11|-21.07|<0.0001
71899370|NCT00570739|143321541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.46||||0.2289|TWO_SIDED|95.0|-27.53|6.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||6.62|-27.53|0.2289
71899371|NCT00570739|143321541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.1997|TWO_SIDED|95.0|-29.22|6.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||6.14|-29.22|0.1997
71899372|NCT00570739|143321542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.81||||0.0144|TWO_SIDED|95.0|2.57|23.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.05|2.57|0.0144
71899373|NCT00570739|143321542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12||||0.0037|TWO_SIDED|95.0|4.63|23.61||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides||23.61|4.63|0.0037
71899374|NCT00570739|143321542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.79||||0.006|TWO_SIDED|95.0|6.59|39.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.00|6.59|0.0060
71899375|NCT00570739|143321542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.72||||0.0013|TWO_SIDED|95.0|9.71|39.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides||39.73|9.71|0.0013
71899376|NCT00570739|143321542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35||||0.0005|TWO_SIDED|95.0|3.71|13.0|||ANCOVA|||Calculated High Density Lipoprotein-Cholesterol||13.00|3.71|0.0005
71899377|NCT00570739|143321542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.69||||0.0001|TWO_SIDED|95.0|4.27|13.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated High Density Lipoprotein-Cholesterol||13.11|4.27|0.0001
71679094|NCT02100670|142876019|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.07||||0.6216|TWO_SIDED|95.0|0.82|1.4||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.|||1.40|0.82|0.6216
71679095|NCT02100670|142876023|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|2.43||||0.0408|TWO_SIDED|95.0|1.04|5.7||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||5.70|1.04|0.0408
71899378|NCT00570739|143321543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.8804|TWO_SIDED|95.0|0.63|2.34||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.34|0.63|0.8804
71899379|NCT00570739|143321543|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5525|TWO_SIDED|95.0|0.73|2.6||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||2.60|0.73|0.5525
71679096|NCT02100670|142876023|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.31||||0.4507|TWO_SIDED|95.0|0.65|2.65||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.65|0.65|0.4507
71679097|NCT02100670|142876023|SUPERIORITY_OR_OTHER||Cox proportional hazard ratio|1.38||||0.315|TWO_SIDED|95.0|0.73|2.61||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.|||2.61|0.73|0.3150
71848454|NCT00749944|143211055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.8|5.3|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.3|0.8|
71848455|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||||TWO_SIDED|95.0|0.5|4.9|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||4.9|0.5|
71848456|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|2.0|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.0|0.4|
71848457|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
71848458|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.4|
71899380|NCT00570739|143321543|SUPERIORITY_OR_OTHER|||||||0.5648||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.5648
71679098|NCT00908791|142876045|SUPERIORITY_OR_OTHER|||||||0.003|||||||McNemar|exact McNemar test for paired binary data.||||||0.003
71848459|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.3|1.6|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.6|0.3|
71679099|NCT00908791|142876046|SUPERIORITY_OR_OTHER|||||||0.41|||||||McNemar|||||||0.41
71679100|NCT00908791|142876047|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|95.0|||||bowker's test of symmetry|||||||0.48
71848460|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.8|0.4|
71899381|NCT00570739|143321543|SUPERIORITY_OR_OTHER|||||||0.317||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.3170
71899382|NCT00570739|143321544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.9008|TWO_SIDED|95.0|0.66|4.06||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||4.06|0.66|0.9008
71899383|NCT00570739|143321544|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.9035|TWO_SIDED|95.0|0.6|3.37||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.37|0.60|0.9035
71899384|NCT00570739|143321544|SUPERIORITY_OR_OTHER|||||||0.2874||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2874
71899385|NCT00570739|143321544|SUPERIORITY_OR_OTHER|||||||0.4344||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4344
71679101|NCT00908791|142876048|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|95.0|||||Sign test|||The Sign-Rank test for paired data.||||0.029
71848461|NCT00749944|143211056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.7|0.4|
71848462|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.3|2.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.3|
71848463|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.4|1.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||1.9|0.4|
71848464|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.2|0.4|
71848465|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.5|2.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.6|0.5|
71848466|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.3|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.3|0.5|
71848467|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.6|2.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.7|0.6|
71848468|NCT00749944|143211057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.5|2.8|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||2.8|0.5|
71848469|NCT00749944|143211059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
71848470|NCT00749944|143211059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.6|0.0|
71848471|NCT00749944|143211059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.6|0.3|
71848472|NCT00749944|143211059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
71848473|NCT00749944|143211059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||5.7|0.0|
71848474|NCT00749944|143211059|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||3.7|0.3|
71848475|NCT00749944|143211060|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.2|23.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.||23.6|0.2|
71848476|NCT00923078|143211076|OTHER||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|1.02|<|0.05|TWO_SIDED|95.0|0.17|4.23|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||4.23|0.17|<0.05
71848477|NCT00923078|143211076|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_ERROR_OF_MEAN|1.02||0.48|TWO_SIDED|95.0|-2.75|1.31|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.31|-2.75|0.48
71848478|NCT00923078|143211076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|1.02|<|0.01|TWO_SIDED|95.0|-4.95|-0.9|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.90|-4.95|<0.01
71679102|NCT00908791|142876049|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||||||0.62
71679103|NCT00908791|142876050|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
71816331|NCT01678820|143134863|SUPERIORITY_OR_OTHER||Difference in least squares means|0.5||||0.857|TWO_SIDED|95.0|-4.8|5.8|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.8|-4.8|0.857
71816332|NCT01678820|143134863|SUPERIORITY_OR_OTHER||Difference in least squares means|0.4||||0.879|TWO_SIDED|95.0|-4.8|5.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.6|-4.8|0.879
71816333|NCT01678820|143134864|SUPERIORITY_OR_OTHER||Difference in least squares means|-30.4||||0.004|TWO_SIDED|95.0|-51.0|-9.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||-9.7|-51.0|0.004
71816334|NCT01678820|143134864|SUPERIORITY_OR_OTHER||Difference in least squares means|-15.3||||0.141|TWO_SIDED|95.0|-35.8|5.1|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.||||5.1|-35.8|0.141
71816335|NCT01678820|143134865|SUPERIORITY_OR_OTHER||Difference in percents|0.3|||||TWO_SIDED|95.0|-12.2|12.9|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple impuattions.|||12.9|-12.2|
71848479|NCT00923078|143211077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.295|<|0.05|TWO_SIDED|95.0|0.08|1.25|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.25|0.08|<0.05
71848480|NCT00923078|143211077|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.295||0.09|TWO_SIDED|95.0|-0.08|1.09|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.09|-0.08|0.09
71816336|NCT01678820|143134865|SUPERIORITY_OR_OTHER||Difference in percents|12.3|||||TWO_SIDED|95.0|0.7|24.0|||||Based on Miettinen \& Nurminen method. Missing data were imputed by multiple imputations.|||24.0|0.7|
71848481|NCT00923078|143211077|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.295||0.59|TWO_SIDED|95.0|-0.75|0.43|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.43|-0.75|0.59
71848482|NCT00923078|143211078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.03|STANDARD_ERROR_OF_MEAN|0.75|<|0.01|TWO_SIDED|95.0|-3.53|-0.52||Post-test scores following Auditory Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.52|-3.53|<0.01
71899386|NCT00570739|143321545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.62|||<|0.0001|TWO_SIDED|95.0|-24.61|-14.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-14.63|-24.61|<0.0001
71899387|NCT00570739|143321545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47|||<|0.0001|TWO_SIDED|95.0|-23.24|-11.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-11.69|-23.24|<0.0001
71816337|NCT03349268|143134878|SUPERIORITY|||||||0.23|||||||Poisson regression|||||||0.23
71816338|NCT00985543|143134879|NON_INFERIORITY_OR_EQUIVALENCE|Results are considered statistically significant at p\<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.|||||<|0.05|TWO_SIDED|90.0|||||maximum likelihood regression|||Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0-12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.||||<0.05
71816339|NCT00692406|143134915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0023|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71816340|NCT00692406|143134916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1167|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71816341|NCT00692406|143134917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0253|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71816342|NCT00692406|143134918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1432|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71816343|NCT00692406|143134919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0489|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71899388|NCT00570739|143321546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||<|0.0001|TWO_SIDED|95.0|-16.26|-8.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-8.69|-16.26|<0.0001
71899389|NCT00570739|143321546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.28|||<|0.0001|TWO_SIDED|95.0|-15.15|-5.41||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-5.41|-15.15|<0.0001
71899390|NCT00570739|143321546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.06||||0.0002|TWO_SIDED|95.0|-13.69|-4.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-4.42|-13.69|0.0002
71899391|NCT00570739|143321547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.96||||0.0357|TWO_SIDED|95.0|0.27|7.66||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||7.66|0.27|0.0357
71679104|NCT00908791|142876051|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|95.0|||||Other|||||||>0.05
71899392|NCT00570739|143321547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.6878|TWO_SIDED|95.0|-5.01|3.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||3.31|-5.01|0.6878
71899393|NCT00570739|143321547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.7972|TWO_SIDED|95.0|-4.37|3.36||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||3.36|-4.37|0.7972
71899394|NCT00570739|143321548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.91|||<|0.0001|TWO_SIDED|95.0|-12.02|-5.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.80|-12.02|<0.0001
71899395|NCT00570739|143321548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-12.25|-4.26||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-4.26|-12.25|<0.0001
71899396|NCT00570739|143321548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.23||||0.0002|TWO_SIDED|95.0|-11.03|-3.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.44|-11.03|0.0002
71899397|NCT00570739|143321549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.0257|TWO_SIDED|95.0|0.43|6.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||6.57|0.43|0.0257
71899398|NCT00570739|143321549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.2238|TWO_SIDED|95.0|-1.32|5.58||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||5.58|-1.32|0.2238
71899399|NCT00570739|143321549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.2763|TWO_SIDED|95.0|-1.44|4.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||4.99|-1.44|0.2763
71899400|NCT00570739|143321550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.83|||<|0.0001|TWO_SIDED|95.0|-13.68|-5.98||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||-5.98|-13.68|<0.0001
71899401|NCT00570739|143321550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.67||||0.0004|TWO_SIDED|95.0|-13.4|-3.94||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||-3.94|-13.40|0.0004
71899402|NCT00570739|143321550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.09||||0.0004|TWO_SIDED|95.0|-12.5|-3.68||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-3.68|-12.50|0.0004
71899403|NCT00570739|143321551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8||||0.0007|TWO_SIDED|95.0|5.87|21.74||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||21.74|5.87|0.0007
71899404|NCT00570739|143321551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.58||||0.0901|TWO_SIDED|95.0|-1.83|24.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||24.99|-1.83|0.0901
71899405|NCT00570739|143321551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.45||||0.0918|TWO_SIDED|95.0|-1.71|22.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a||Baseline to 16 Weeks LOCF||22.62|-1.71|0.0918
71899406|NCT00570739|143321552|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|15.78||||0.0005|TWO_SIDED|95.0|6.27|25.83||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 8 Weeks||25.83|6.27|0.0005
71899407|NCT00570739|143321552|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.07||||0.0011|TWO_SIDED|95.0|6.33|26.02||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||26.02|6.33|0.0011
71899408|NCT00570739|143321552|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.33||||0.0009|TWO_SIDED|95.0|5.11|23.84||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||23.84|5.11|0.0009
71899409|NCT00570739|143321553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.29||||0.6523|TWO_SIDED|95.0|-17.5|10.32||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks||10.32|-17.50|0.6523
71848483|NCT00923078|143211078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.45|STANDARD_ERROR_OF_MEAN|0.75||0.01|TWO_SIDED|95.0|-3.95|-0.94||Post-test scores following Visual Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.94|-3.95|0.01
71848484|NCT00923078|143211078|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.75||0.58|TWO_SIDED|95.0|-1.93|1.08||Post-test scores following Auditory Cognitive Training as compared to Visual Cognitive Training, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.08|-1.93|0.58
71848485|NCT00923078|143211079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.55||0.06|TWO_SIDED|95.0|-6.02|0.18|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.18|-6.02|0.06
71848486|NCT00923078|143211079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.24|STANDARD_ERROR_OF_MEAN|1.55|<|0.05|TWO_SIDED|95.0|-6.34|-0.14|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||-0.14|-6.34|< 0.05
71848487|NCT00923078|143211079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.55||0.84|TWO_SIDED|95.0|-3.42|2.78|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.78|-3.42|0.84
71848488|NCT00923078|143211080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62|STANDARD_ERROR_OF_MEAN|1.04||0.55|TWO_SIDED|95.0|-1.45|2.69|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.69|-1.45|0.55
71848489|NCT00923078|143211080|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|1.03||0.98|TWO_SIDED|95.0|-2.02|2.07|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.07|-2.02|0.98
71848490|NCT00923078|143211080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.04||0.57|TWO_SIDED|95.0|-2.66|1.47|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.47|-2.66|0.57
71899410|NCT00570739|143321553|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.38||||0.3934|TWO_SIDED|95.0|-17.51|8.77||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF||8.77|-17.51|0.3934
71899411|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.9838|TWO_SIDED|95.0|-8.66|8.84||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||8.84|-8.66|0.9838
71899412|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.7157|TWO_SIDED|95.0|-6.73|9.79||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles||9.79|-6.73|0.7157
71899413|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|||<|0.0001|TWO_SIDED|95.0|1.25|3.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.63|1.25|<0.0001
71899414|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39|||<|0.0001|TWO_SIDED|95.0|1.27|3.51||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles||3.51|1.27|<0.0001
71899415|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.04||||0.0577|TWO_SIDED|95.0|-0.17|10.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.24|-0.17|0.0577
71899416|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24||||0.039|TWO_SIDED|95.0|0.27|10.22||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles||10.22|0.27|0.0390
71679105|NCT03192995|142876053|SUPERIORITY|||||||0.91|||||||Fisher Exact|||||||0.91
71679106|NCT03192995|142876054|SUPERIORITY|||||||0.53|||||||Fisher Exact|||||||0.53
71679107|NCT03192995|142876055|SUPERIORITY|||||||0.32|||||||Fisher Exact|||||||.32
71899417|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.49||||0.0044|TWO_SIDED|95.0|-12.61|-2.37||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-2.37|-12.61|0.0044
71899418|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.24||||0.0118|TWO_SIDED|95.0|-11.09|-1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles||-1.40|-11.09|0.0118
71899419|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-110.6||||0.0293|TWO_SIDED|95.0|-209.9|-11.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-11.3|-209.9|0.0293
71899420|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-112.7||||0.0202|TWO_SIDED|95.0|-207.6|-17.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles||-17.8|-207.6|0.0202
71899421|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.9629|TWO_SIDED|95.0|-15.2|14.5|||ANCOVA|||Intermediate Density Lipoprotein (LDL) Particles||14.5|-15.2|0.9629
71679108|NCT03192995|142876056|SUPERIORITY|||||||0.541|||||||Fisher Exact|||||||.541
71679109|NCT03192995|142876057|SUPERIORITY||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.24|3.82||||||||3.82|0.24|
71679110|NCT02579343|142876069|SUPERIORITY|||||||0.05||||||P-value above was calculated. Does not reference threshold for clinical significance.|Repeated Measures Analysis of Variance|||||||.05
71679111|NCT02579343|142876070|SUPERIORITY|||||||0.05|||||||Repeated Measures Analysis of Variance|||||||.05
71679112|NCT05027048|142876106|SUPERIORITY||Mean Difference (Net)|211.0|||<|0.05|TWO_SIDED|95.0|-33.0|410.0||a priori threshold for statistical significance p\<0.05|inverse Gaussian distribution and log li|Inverse Gaussian distribution and log link fit to estimate the effect size and 95% CIs|Inverse gaussian regression with a log link was used to calculate the mean reduction in blood loss in the calcium group relative to placebo group.|||410|-33|<0.05
71679113|NCT05027048|142876107|SUPERIORITY||Risk Ratio (RR)|0.71|||||TWO_SIDED|95.0|0.48|1.03|||Regression (poisson with robust SE)|||||1.03|0.48|
71679114|NCT05027048|142876108|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.46|1.23|||Poisson regression with robust SE|||||1.23|0.46|
71679115|NCT05027048|142876109|SUPERIORITY||Risk Ratio (RR)|0.56|||||TWO_SIDED|95.0|0.2|1.56||||||||1.56|0.2|
71679116|NCT05027048|142876110|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.6|0.2|||Regression, Linear|Data were log transformed to approximate a normal distribution prior to linear regression.||||0.2|-3.6|
71679117|NCT05027048|142876112|SUPERIORITY|||||||0.415|||||||Wilcoxon (Mann-Whitney)|||||||0.415
71679118|NCT05027048|142876113|SUPERIORITY|||||||0.566|||||||Wilcoxon (Mann-Whitney)|||||||0.566
71899422|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.7485|TWO_SIDED|95.0|-16.5|11.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein (LDL) Particles||11.9|-16.5|0.7485
71899423|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.6||||0.1007|TWO_SIDED|95.0|-139.7|12.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||12.5|-139.7|0.1007
71899424|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.8||||0.0768|TWO_SIDED|95.0|-134.6|6.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles||6.9|-134.6|0.0768
71899425|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.7||||0.4143|TWO_SIDED|95.0|-162.7|67.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||67.3|-162.7|0.4143
71899426|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.9||||0.402|TWO_SIDED|95.0|-157.1|63.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles||63.3|-157.1|0.4020
71899427|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6||||0.6378|TWO_SIDED|95.0|-29.1|17.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||17.9|-29.1|0.6378
71899428|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.5528|TWO_SIDED|95.0|-29.1|15.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles||15.6|-29.1|0.5528
71899429|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.0||||0.373|TWO_SIDED|95.0|-134.8|50.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||50.8|-134.8|0.3730
71899430|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.0||||0.3764|TWO_SIDED|95.0|-129.0|49.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles||49.0|-129.0|0.3764
71899431|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9807|TWO_SIDED|95.0|-1.2|1.17||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.17|-1.20|0.9807
71899432|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8615|TWO_SIDED|95.0|-1.23|1.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles||1.03|-1.23|0.8615
71899433|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.0364|TWO_SIDED|95.0|0.04|1.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.14|0.04|0.0364
71899434|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.034|TWO_SIDED|95.0|0.04|1.08||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles||1.08|0.04|0.0340
71899435|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.6587|TWO_SIDED|95.0|-0.68|1.07||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.07|-0.68|0.6587
71899436|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.6554|TWO_SIDED|95.0|-0.63|1.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles||1.00|-0.63|0.6554
71899437|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.1957|TWO_SIDED|95.0|-2.06|0.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.42|-2.06|0.1957
71899438|NCT00570739|143321554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.1622|TWO_SIDED|95.0|-2.03|0.34||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles||0.34|-2.03|0.1622
71899439|NCT00570739|143321555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|||<|0.0001|TWO_SIDED|95.0|3.51|8.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||8.48|3.51|<0.0001
71848491|NCT00923078|143211081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|1.27||0.63|TWO_SIDED|95.0|-3.14|1.93|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.93|-3.14|0.63
71899440|NCT00570739|143321555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.31|||<|0.0001|TWO_SIDED|95.0|3.0|7.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles||7.63|3.00|<0.0001
71679119|NCT05027048|142876115|SUPERIORITY|||||||0.348|||||||ANOVA|||Repeated measures ANOVA used to analyze differences between groups.||||0.348
71679120|NCT05027048|142876116|SUPERIORITY|||||||0.011|||||||ANOVA|Repeated measures ANOVA.||Repeated measures ANOVA used to assess for difference between groups in the % change from baseline heart rate.||||0.011
71679121|NCT05027048|142876118|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71679122|NCT05027048|142876119|OTHER||||||||||||||||||"Note: a two-compartment pharmacokinetic model was generated in NONMEM using 6 venous blood ionized calcium measurements per participant at random times. The change in ionized calcium was defined as a measured value minus the measured baseline for the patient.~Once the two-compartment pharmacokinetic model was generated, NONMEM was used to generate a predicted ionized calcium concentration at 10 minutes (Tmax) for each participant to generate mean and 95% confidence interval."|||
71848492|NCT00923078|143211081|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|1.27||0.47|TWO_SIDED|95.0|-3.45|1.61|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.61|-3.45|0.47
71848493|NCT00923078|143211081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|1.27||0.8|TWO_SIDED|95.0|-2.85|2.22|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||2.22|-2.85|0.80
71848494|NCT00923078|143211082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.98||0.26|TWO_SIDED|95.0|-3.06|0.85|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.85|-3.06|0.26
71848495|NCT00923078|143211082|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.47|STANDARD_ERROR_OF_MEAN|0.97||0.13|TWO_SIDED|95.0|-3.41|0.46|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||0.46|-3.41|0.13
71848496|NCT00923078|143211082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.98||0.71|TWO_SIDED|95.0|-2.32|1.58|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)||1.58|-2.32|0.71
71848497|NCT03547154|143211095|SUPERIORITY_OR_OTHER|||||||0.322||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||0.322
71848498|NCT03547154|143211096|SUPERIORITY_OR_OTHER||||||>|0.999||||||Analysis of Major Response|Fisher Exact|Missing data considered failures||||||>0.999
71848499|NCT03547154|143211097|SUPERIORITY_OR_OTHER|||||||0.588||||||Analysis of Complete Response|Fisher Exact|Missing data considered failures||||||0.588
71848500|NCT03547154|143211098|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.859|||||TWO_SIDED|95.0|0.429|1.721|||||Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox's proportional hazards model.|||1.721|0.429|
71848501|NCT01543204|143211127|SUPERIORITY_OR_OTHER||Difference|10.0||||0.4505|TWO_SIDED|95.0|-15.97|35.97|||Wald asymptotic test|||||35.97|-15.97|0.4505
71848502|NCT02449902|143211159|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71848503|NCT02449902|143211160|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||||||0.0002
71848504|NCT02449902|143211161|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||ANCOVA|||||||0.0017
71848505|NCT02449902|143211162|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANCOVA|||||||0.0002
71848506|NCT02449902|143211163|SUPERIORITY_OR_OTHER|||||||0.9951|TWO_SIDED||||||ANOVA|||||||0.9951
71848507|NCT02449902|143211164|SUPERIORITY_OR_OTHER|||||||0.1429|TWO_SIDED||||||Fisher Exact|||||||0.1429
71848508|NCT02449902|143211165|SUPERIORITY_OR_OTHER|||||||0.1945|TWO_SIDED||||||ANCOVA|||||||0.1945
71848509|NCT02449902|143211166|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
71848510|NCT02449902|143211167|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||ANCOVA|||||||0.1820
71848511|NCT02449902|143211168|SUPERIORITY_OR_OTHER|||||||0.0401|TWO_SIDED||||||ANCOVA|||||||0.0401
71848512|NCT02362789|143211169|SUPERIORITY||Mean Difference (Net)|-18.3||||0.0055|TWO_SIDED|95.0|-31.01|-5.59|||ANCOVA|||||-5.59|-31.01|0.0055
71848513|NCT02684136|143211172|SUPERIORITY||||||<|0.05|||||||ANCOVA|baseline used as covariate||||||<0.05
71848514|NCT02684136|143211173|SUPERIORITY||||||<|0.05||||||baseline used as covariate|ANCOVA|||||||<0.05
71679123|NCT05027048|142876121|SUPERIORITY||Mean Difference (Net)|356.0|||<|0.05|TWO_SIDED|95.0|159.0|515.0|||Inverse Gaussian regression, log link||Reduction in blood loss was calculated by inverse Gaussian regression with a log link as detailed in the description of statistical methods for the primary outcome.|||515|159|<0.05
71679124|NCT01871402|142876133|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
71848515|NCT00068107|143211179|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||eGFR measured pre-study was compared to eGFR during the study||||0.01
71848516|NCT00068107|143211179|SUPERIORITY_OR_OTHER||Average Delay in time to ESRD|166.0|||||TWO_SIDED|95.0|8.4|323.8|||||The average delay in end stage renal disease (ESRD) calculated from the eGFR values and represents the estimated difference in time to ESRD between Relagal administered every 2 weeks and Relagal administered weekly. Units = months|||323.8|8.4|
71848517|NCT01316913|143211194|SUPERIORITY_OR_OTHER||Least squares mean difference|0.022||||0.377|TWO_SIDED|95.0|-0.027|0.072|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.|||0.072|-0.027|0.377
71848518|NCT01316913|143211194|SUPERIORITY_OR_OTHER||Least squares mean difference|0.06||||0.018|TWO_SIDED|95.0|0.01|0.109||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.109|0.010|0.018
71848519|NCT01316913|143211194|SUPERIORITY_OR_OTHER||Least squares mean difference|0.037||||0.142|TWO_SIDED|95.0|-0.012|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.|||0.087|-0.012|0.142
71848520|NCT01316913|143211194|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.003|TWO_SIDED|95.0|0.025|0.123|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.|||0.123|0.025|0.003
71848521|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-63.09|60.57|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||60.57|-63.09|
71848522|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|-27.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-91.24|36.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||36.97|-91.24|
71848523|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|43.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|-32.19|119.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||119.62|-32.19|
71848524|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|61.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-6.38|129.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||129.35|-6.38|
71848525|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|125.87|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|60.51|191.23|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||191.23|60.51|
71848526|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|156.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|84.99|227.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||227.45|84.99|
71848527|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|51.42|STANDARD_ERROR_OF_MEAN|33.12|||TWO_SIDED|90.0|-3.57|106.41|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||106.41|-3.57|
71848528|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|142.74|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|82.76|202.72|||||Test (PF-05251749 200 mg PM) Reference (Placebo)|||202.72|82.76|
71848529|NCT02691702|143211224|OTHER|MMRM|Mean Difference (Final Values)|174.9|STANDARD_ERROR_OF_MEAN|36.01|||TWO_SIDED|90.0|115.11|234.69|||||Test (PF-05251749 500 mg PM) Reference (Placebo)|||234.69|115.11|
71848530|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|-71.26|STANDARD_ERROR_OF_MEAN|37.24|||TWO_SIDED|90.0|-133.09|-9.43|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)|||-9.43|-133.09|
71848531|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|-12.13|STANDARD_ERROR_OF_MEAN|38.61|||TWO_SIDED|90.0|-76.24|51.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)|||51.97|-76.24|
71848532|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|88.72|STANDARD_ERROR_OF_MEAN|45.72|||TWO_SIDED|90.0|12.81|164.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)|||164.62|12.81|
71848533|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|46.48|STANDARD_ERROR_OF_MEAN|40.88|||TWO_SIDED|90.0|-21.38|114.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||114.35|-21.38|
71848534|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|87.3|STANDARD_ERROR_OF_MEAN|39.37|||TWO_SIDED|90.0|21.94|152.66|||||Test (PF-05251749 400 mg AM) Reference (Placebo)|||152.66|21.94|
71848535|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|126.22|STANDARD_ERROR_OF_MEAN|42.91|||TWO_SIDED|90.0|54.99|197.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)|||197.45|54.99|
71848536|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|92.36|STANDARD_ERROR_OF_MEAN|35.48|||TWO_SIDED|90.0|33.51|151.21|||||Test (PF-05251749 50 mg PM) Reference (Placebo)|||151.21|33.51|
71848537|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|107.29|STANDARD_ERROR_OF_MEAN|36.13|||TWO_SIDED|90.0|47.31|167.27|||||Test (PF-05251749 200 mg AM) Reference (Placebo)|||167.27|47.31|
71848538|NCT02691702|143211225|OTHER|MMRM|Mean Difference (Final Values)|140.61|STANDARD_ERROR_OF_MEAN|37.79|||TWO_SIDED|90.0|77.91|203.3|||||Test (PF-05251749 500 mg AM) Reference (Placebo)|||203.30|77.91|
71848539|NCT01860079|143211241|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared, Corrected|||Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.||||<0.05
71848540|NCT00786188|143211242|SUPERIORITY_OR_OTHER|||||||0.0177||||||Week 4 frequency|Repeated measures analysis|||||||0.0177
71848541|NCT00786188|143211242|SUPERIORITY_OR_OTHER|||||||0.0541||||||Week 8 frequency|Reapeated measures analysis|||||||0.0541
71848542|NCT00786188|143211243|SUPERIORITY_OR_OTHER|||||||0.0644||||||Week 4 severity|Reapeated measures analysis|||||||0.0644
71848543|NCT00786188|143211243|SUPERIORITY_OR_OTHER|||||||0.0364||||||Week 8 severity|Reapeated measures analysis|||||||0.0364
71899441|NCT00570739|143321555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1742|TWO_SIDED|95.0|-0.3|0.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles||0.05|-0.30|0.1742
71848544|NCT02970318|143211293|OTHER||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.2|0.49||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.49|0.20|<0.0001
71848545|NCT02970318|143211294|OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.38||Stratified by randomization stratification factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.38|0.20|<0.0001
71848546|NCT02970318|143211295|OTHER||Risk Difference (RD)|5.8||||0.2248|TWO_SIDED|95.0|-3.3|14.9|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||14.9|-3.3|0.2248
71848547|NCT02970318|143211296|OTHER||Risk Difference (RD)|-1.3||||0.734|TWO_SIDED|95.0|-9.6|7.0|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|Risk difference (% Arm A - Arm B) based on Cochran-Mantel-Haenszel test with adjustment for randomization stratification factors as recorded in IXRS.|||7.0|-9.6|0.7340
71848548|NCT02970318|143211297|OTHER||Hazard Ratio (HR)|0.69||||0.0783|TWO_SIDED|95.0|0.46|1.04|||Log Rank|Log-Rank Analysis stratified by factors recorded in IXRS data: presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Cox proportional hazard analysis stratified (Arm A vs. Arm B) by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).|Analysis stratified by factors recorded in IXRS data including presence of deletion 17 p (yes / no), ECOG (0-1/2), # of prior therapies (1-3/4+).||1.04|0.46|0.0783
71848549|NCT02970318|143211298|OTHER||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.19|0.59||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.59|0.19|<0.0001
71848550|NCT02970318|143211299|OTHER||Hazard Ratio (HR)|0.23|||<|0.0001|TWO_SIDED|95.0|0.16|0.33||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.33|0.16|<0.0001
71848551|NCT02970318|143211300|OTHER||Hazard Ratio (HR)|0.29|||<|0.0001|TWO_SIDED|95.0|0.21|0.4||Log Rank Test stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|Log Rank||Cox Proportional Hazard Model (Arm A vs. Arm B) stratified by factors as recorded in IXRS, i.e., presence of del17p (Yes/No), ECOG (0-1/2), # of prior therapies (1-3/4+).|||0.40|0.21|<0.0001
71848552|NCT00824408|143211301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.045||||0.003|TWO_SIDED|95.0|1.271|3.292|||Log Rank|||Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||3.292|1.271|0.0030
71848553|NCT00824408|143211301|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.141||||0.2804|TWO_SIDED|95.0|0.735|1.771|||Log Rank|||Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).||1.771|0.735|0.2804
71848554|NCT00824408|143211302|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Fisher Exact|||||||>0.9999
71848555|NCT00824408|143211302|SUPERIORITY_OR_OTHER|||||||0.2596|||||||Fisher Exact|||||||0.2596
71848556|NCT00824408|143211303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.073||||0.8406|TWO_SIDED|95.0|0.538|2.14|||Log Rank|||||2.140|0.538|0.8406
71848557|NCT00824408|143211303|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.081||||0.396|TWO_SIDED|95.0|0.599|1.949|||Log Rank|||||1.949|0.599|0.3960
71848558|NCT03292692|143211314|SUPERIORITY||Slope|0.372|||<|0.001|TWO_SIDED|95.0|0.279|0.465|||Regression, Linear|Multi-level regression|Slope of intervention group compared to slope of the control group|||0.465|0.279|<0.001
71848559|NCT03292692|143211315|SUPERIORITY||Slope|0.17|||<|0.001|TWO_SIDED|95.0|0.105|0.235|||Regression, Linear|Multilevel linear modeling|Slope of the intervention group compared to slope of the control group|||0.235|0.105|<0.001
71848560|NCT03292692|143211316|SUPERIORITY||Mean Difference (Final Values)|-2.149|||<|0.001|TWO_SIDED|95.0|-2.974|-1.324|||Regression, Linear|Multilevel linear regression|Multilevel linear modeling, with time modeled as change from pre-post.|||-1.324|-2.974|<0.001
71848561|NCT03292692|143211317|SUPERIORITY||Mean Difference (Final Values)|-1.144||||0.002|TWO_SIDED|95.0|-1.871|-0.417|||Regression, Linear||Multilevel linear modeling, with time modeled as change from pre to post.|||-0.417|-1.871|0.002
71848562|NCT01075152|143211351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.73||||0.03|TWO_SIDED|95.0|1.06|2.82||A Lan-DeMets spending function analog of the O'Brien-Fleming boundaries was proposed to control the type-I error resulting from multiple interim analyses.|Regression, Cox||Hazard Ratio describes the risk of earlier HIV therapy in comparison to deferred HIV therapy initiation as the reference group.|"We compared the randomization arms for the primary endpoint of survival using time-to-event methods of Cox proportional hazards models by the intention-to-treat principle, based on two-sided type-I error with alpha=0.05.~The trial was statistically powered to detect a 25% relative survival benefit (15% absolute benefit) with 90% power and overall two-sided alpha=0.05 with an intended sample size of 500 participants. The trial was halted early by the Data and Safety Monitoring Board."||2.82|1.06|0.03
71899442|NCT00570739|143321555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.187|TWO_SIDED|95.0|-0.28|0.06|||ANCOVA|||Low Density Lipoprotein Particles||0.06|-0.28|0.1870
71899443|NCT00570739|143321555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.0063|TWO_SIDED|95.0|0.03|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.03|0.0063
71679125|NCT01871402|142876134|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
71679126|NCT01871402|142876135|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71899444|NCT00570739|143321555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.002|TWO_SIDED|95.0|0.04|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles||0.16|0.04|0.0020
71899445|NCT00570739|143321556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4||||0.0022|TWO_SIDED|95.0|8.9|39.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.9|8.9|0.0022
71899446|NCT00570739|143321556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.3||||0.0013|TWO_SIDED|95.0|9.6|39.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides||39.1|9.6|0.0013
71899447|NCT00570739|143321556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.3||||0.0006|TWO_SIDED|95.0|11.5|41.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||41.0|11.5|0.0006
71899448|NCT00570739|143321556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.5||||0.0003|TWO_SIDED|95.0|12.5|40.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides||40.6|12.5|0.0003
71899449|NCT00570739|143321556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1257|TWO_SIDED|95.0|-0.4|3.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.5|-0.4|0.1257
71679127|NCT01871402|142876136|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance (\<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).||||<0.001
71899450|NCT00570739|143321556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1054|TWO_SIDED|95.0|-0.3|3.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol||3.3|-0.3|0.1054
71899451|NCT00570739|143321557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2971|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||0.03|-0.11|0.2971
71899452|NCT00570739|143321557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2567|TWO_SIDED|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.03|-0.11|0.2567
71899453|NCT00570739|143321557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.1081|TWO_SIDED|95.0|-0.13|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.01|-0.13|0.1081
71899454|NCT00570739|143321557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.079|TWO_SIDED|95.0|-0.17|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.01|-0.17|0.0790
71899455|NCT00570739|143321557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.0206|TWO_SIDED|95.0|-0.18|-0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||-0.01|-0.18|0.0206
71679128|NCT02357706|142876219|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs"|Mean Difference (Final Values)|1.24||||0.537|TWO_SIDED||||||t-test, 1 sided|||"Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test"||||0.537
71899456|NCT00570739|143321558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3||||0.0009|TWO_SIDED|95.0|-6.8|-1.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||-1.8|-6.8|0.0009
71899457|NCT00570739|143321558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.1184|TWO_SIDED|95.0|-4.5|0.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||0.5|-4.5|0.1184
71899458|NCT00570739|143321558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.0615|TWO_SIDED|95.0|-5.8|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks||0.1|-5.8|0.0615
71816344|NCT00692406|143134920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0096|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71848563|NCT01075152|143211352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.32
71816345|NCT00692406|143134921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0372|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71816346|NCT00692406|143134922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.||||<0.001
71816347|NCT02307513|143134940|SUPERIORITY||Difference in LS Mean|-92.6|||<|0.0001|TWO_SIDED|95.0|-130.59|-54.6|||ANCOVA|ANCOVA model with AUC W0-12 as the response variables; treatment arm, sex, region as factors and the number of oral ulcers at baseline as a covariate.|Treatment difference = Apremilast - Placebo|The AUC W0-12 for oral ulcer counts was compared between the placebo treatment group and the apremilast 30 BID treatment group using a 2-tailed parametric analysis of covariance (ANCOVA) test at the 0.05 significance level.||-54.60|-130.59|<0.0001
71816348|NCT02307513|143134941|SUPERIORITY||Difference in LS Mean|-24.8|||<|0.0001|TWO_SIDED|95.0|-32.8|-16.8|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-16.8|-32.8|<0.0001
71816349|NCT02307513|143134942|SUPERIORITY||Difference in LS Mean|-11.94|||<|0.0001|TWO_SIDED|95.0|-16.2|-7.67|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-7.67|-16.20|<0.0001
71816350|NCT02307513|143134943|SUPERIORITY||Difference in LS Means|-0.5||||0.0335|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.0|-1.0|0.0335
71848564|NCT01075152|143211353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).||||0.06
71848565|NCT01075152|143211354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.98
71848566|NCT01075152|143211355|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.66||||0.04|TWO_SIDED|95.0|1.03|2.68|||Regression, Cox|||We compared the randomization arms for survival using time-to-event methods of Cox proportional hazards models.||2.68|1.03|0.04
71848567|NCT01075152|143211356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.26
71848568|NCT01075152|143211357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher's exact tests.||||0.23
71848569|NCT01075152|143211358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||repeated measure analysis|||The overall change from baseline in Karnofsky performance status scores was compared between groups via a repeated measure analysis, unstructured covariance matrix, adjusted for baseline value.||||0.34
71816351|NCT02307513|143134944|SUPERIORITY||Difference in LS Means|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.6|-1.4|<0.0001
71816352|NCT02307513|143134945|SUPERIORITY||Difference in LS Means|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-0.5|-1.3|<0.0001
71816353|NCT02307513|143134946|SUPERIORITY||Adjusted difference in percentages|25.1|||<|0.0001|TWO_SIDED|95.0|15.5|34.6|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||34.6|15.5|<0.0001
71816354|NCT02307513|143134947|SUPERIORITY||Hazard Ratio (HR)|2.4|||<|0.0001|TWO_SIDED|95.0|1.692|3.405|||Stratified Log-Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors.|||3.405|1.692|<0.0001
71848570|NCT01075152|143211359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44|||||||Regression, Linear|a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance||To describe early fungicidal activity, a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance of log10 colony forming units (CFU) of Cryptococcus, per mL of CSF per day, for all participants with \>2 cultures obtained.||||0.44
71848571|NCT01075152|143211360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||This is the interaction p-value for CSF white cell count at randomization (implying there is a statistical difference in the outcome by arm based on this parameter).|Regression, Cox|||Pre-specified subgroups formed by baseline characteristics were compared for 26 week survival with models including an interaction term between treatment arm and subgroup.||||0.02
71848572|NCT02334215|143211361|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||.32
71816355|NCT02307513|143134948|SUPERIORITY||Adjusted difference in percentages|30.6|||<|0.0001|TWO_SIDED|95.0|18.1|43.1|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||43.1|18.1|<0.0001
71816356|NCT02307513|143134949|SUPERIORITY||Difference in LS Mean|-3.0||||0.0003|TWO_SIDED|95.0|-4.5|-1.4|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.||||-1.4|-4.5|0.0003
71816357|NCT02307513|143134950|SUPERIORITY||Adjusted difference in percentages|28.4||||0.11|TWO_SIDED|95.0|-3.6|60.4|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex.|Adjusted difference was the weighted average of the treatment differences across the 2 strata of sex with the CMH weights.|||60.4|-3.6|0.1100
71848573|NCT02334215|143211361|SUPERIORITY|||||||0.32|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.32
71848574|NCT02334215|143211362|SUPERIORITY|||||||0.001|||||||Generalized Linear Mixed Model Analysis|||Contrast of Interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual Conditions||||.001
71848575|NCT02334215|143211362|SUPERIORITY|||||||0.84|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||.84
71848576|NCT02334215|143211363|SUPERIORITY|||||||0.11|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone Conditions combined vs. Enhanced Treatment as Usual||||0.11
71848577|NCT02334215|143211363|SUPERIORITY|||||||0.55|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.55
71848578|NCT02334215|143211364|SUPERIORITY|||||||0.55|||||||Regression, Logistic|||||||0.55
71848579|NCT02334215|143211364|SUPERIORITY|||||||0.57|||||||Regression, Logistic|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.57
71848580|NCT02334215|143211365|SUPERIORITY|||||||0.997|||||||Generalized Linear Mixed Model|||Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||.997
71848581|NCT02334215|143211365|SUPERIORITY|||||||0.26|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.26
71848582|NCT02334215|143211366|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone compared to Enhanced Treatment as Usual||||||0.663|||||||Generalized Linear Mixed Model|||||||.663
71848583|NCT02334215|143211366|SUPERIORITY|||||||0.33|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs Methadone||||0.33
71848584|NCT02334215|143211367|SUPERIORITY|||||||0.007|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone arms compared to Enhanced Treatment as Usual||||0.007
71848585|NCT02334215|143211367|SUPERIORITY|||||||0.76|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.76
71848586|NCT02334215|143211368|SUPERIORITY|||||||0.6|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Enhanced Treatment as Usual||||0.60
71848587|NCT02334215|143211368|SUPERIORITY|||||||1|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||1.0
71848588|NCT02334215|143211369|SUPERIORITY|||||||0.09|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.09
71848589|NCT02334215|143211369|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
71848590|NCT02334215|143211370|SUPERIORITY|||||||0.013|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||.013
71848591|NCT02334215|143211370|SUPERIORITY|||||||0.71|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.71
71848592|NCT02334215|143211371|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.32|||||||Generalized Linear Mixed Model Analysis|||||||.32
71848593|NCT02334215|143211371|SUPERIORITY|||||||0.85|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.85
71848594|NCT02334215|143211372|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.1|||||||Generalized Linear Mixed Model Analysis|||||||.10
71848595|NCT02334215|143211372|SUPERIORITY|||||||0.74|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.74
71848596|NCT02334215|143211373|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.42|||||||Generalized Linear Mixed Model Analysis|||||||.42
71848597|NCT02334215|143211373|SUPERIORITY|||||||0.42|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.42
71816358|NCT02307513|143134951|SUPERIORITY||Adjusted difference in percentages|17.5||||0.0204|TWO_SIDED|95.0|4.2|30.7|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test, adjusting for sex and region.|Adjusted difference was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.|||30.7|4.2|0.0204
71679129|NCT02357706|142876219|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|1.24||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
71848598|NCT02334215|143211374|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.28|||||||Generalized Linear Mixed Model Analysis|||||||.28
71848599|NCT02334215|143211374|SUPERIORITY|||||||0.44|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.44
71848600|NCT02334215|143211375|SUPERIORITY|||||||0.61|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation and Methadone combined vs. Enhanced Treatment as Usual||||.61
71848601|NCT02334215|143211375|SUPERIORITY|||||||0.72|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||0.72
71848602|NCT02334215|143211376|SUPERIORITY|Contrast of interest: Methadone plus Patient Navigation and Methadone vs. Enhanced Treatment as Usual||||||0.71|||||||Generalized Linear Mixed Model Analysis|||||||.71
71848603|NCT02334215|143211376|SUPERIORITY|||||||0.86|||||||Generalized Linear Mixed Model Analysis|||Contrast of interest: Methadone plus Patient Navigation vs. Methadone||||.86
71848604|NCT01523392|143211405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.6|STANDARD_ERROR_OF_MEAN|14.68|<|0.001|TWO_SIDED|95.0|-213.9|-153.3||Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence|Mixed Models Analysis||Ticagrelor minus clopidogrel|||-153.3|-213.9|<0.001
71848605|NCT01523392|143211406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-103.8|STANDARD_ERROR_OF_MEAN|18.79|<|0.001|TWO_SIDED|95.0|-142.5|-65.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 0.5 hours after loading dose||-65.0|-142.5|<0.001
71848606|NCT01523392|143211406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-165.3|STANDARD_ERROR_OF_MEAN|15.45|<|0.001|TWO_SIDED|95.0|-197.4|-133.3|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours after loading dose||-133.3|-197.4|<0.001
71848607|NCT01523392|143211407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-135.0|STANDARD_ERROR_OF_MEAN|12.35|<|0.001|TWO_SIDED|95.0|-160.4|-109.5|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 2 hours on Day 7 after multiple doses||-109.5|-160.4|<0.001
71848608|NCT01523392|143211407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.1|STANDARD_ERROR_OF_MEAN|12.55|<|0.001|TWO_SIDED|95.0|-143.9|-92.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours on Day 7 after multiple doses||-92.2|-143.9|<0.001
71848609|NCT01523392|143211407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-133.4|STANDARD_ERROR_OF_MEAN|12.77|<|0.001|TWO_SIDED|95.0|-159.7|-107.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at end of dosing interval on Day 8||-107.1|-159.7|<0.001
71848610|NCT01377844|143211413|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||||-0.53|-1.06|< 0.0001
71848611|NCT01377844|143211414|SUPERIORITY||Difference of LS Means|-5.53|||<|0.0001|TWO_SIDED|95.0|-8.02|-3.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline systolic BP, baseline HbA1c category, site, age category, gender and race||||-3.04|-8.02|< 0.0001
71848612|NCT01377844|143211414|SUPERIORITY||Difference of LS Means|-2.67||||0.0015|TWO_SIDED|95.0|-4.3|-1.04||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline diastolic BP, baseline HbA1c category, site, age category, gender and race||||-1.04|-4.30|0.0015
71848613|NCT01377844|143211415|SUPERIORITY||Difference of LS Means|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.52|-0.93||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline weight, baseline HbA1c category, site, age category, gender and race||||-0.93|-2.52|< 0.0001
71848614|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.42|-0.21||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 2||-0.21|-0.42|< 0.0001
71848615|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.59|||<|0.0001|TWO_SIDED|95.0|-0.78|-0.41||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 6||-0.41|-0.78|< 0.0001
71899459|NCT00570739|143321558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3||||0.3617|TWO_SIDED|95.0|-7.2|2.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||2.6|-7.2|0.3617
71899460|NCT00570739|143321558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6||||0.2372|TWO_SIDED|95.0|-7.0|1.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.7|-7.0|0.2372
71899461|NCT00570739|143321559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.921||||0.2982|TWO_SIDED|95.0|-0.821|2.663||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks||2.663|-0.821|0.2982
71899462|NCT00570739|143321559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.695||||0.2361|TWO_SIDED|95.0|-0.458|1.848||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks||1.848|-0.458|0.2361
71899463|NCT00570739|143321559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.218||||0.0413|TWO_SIDED|95.0|-2.388|-0.049|||ANCOVA|||Baseline to 12 Weeks||-0.049|-2.388|0.0413
71899464|NCT00570739|143321559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.434||||0.7858|TWO_SIDED|95.0|-3.583|2.715|||ANCOVA|||Baseline to 16 Weeks||2.715|-3.583|0.7858
71899465|NCT00570739|143321559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493||||0.7314|TWO_SIDED|95.0|-3.321|2.335|||ANCOVA|||Baseline to 16 Weeks LOCF||2.335|-3.321|0.7314
71899466|NCT00570739|143321560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.089||||0.553|TWO_SIDED|95.0|-0.385|0.207||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.207|-0.385|0.5530
71899467|NCT00570739|143321560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.105||||0.4554|TWO_SIDED|95.0|-0.383|0.172||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.172|-0.383|0.4554
71899468|NCT00570739|143321561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.8583|TWO_SIDED|95.0|-10.7|8.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||8.9|-10.7|0.8583
71899469|NCT00570739|143321561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.7975|TWO_SIDED|95.0|-10.5|8.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||8.1|-10.5|0.7975
71899470|NCT00570739|143321562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.0||||0.233||95.0|-18.5|4.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||4.5|-18.5|0.2330
71899471|NCT00570739|143321562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.1412|TWO_SIDED|95.0|-19.2|2.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||2.8|-19.2|0.1412
71899472|NCT00570739|143321563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.8192|TWO_SIDED|95.0|-13.7|10.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.8|-13.7|0.8192
71899473|NCT00570739|143321563|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.7513|TWO_SIDED|95.0|-13.5|9.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||9.7|-13.5|0.7513
71899474|NCT00570739|143321564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.91||||0.4301|TWO_SIDED|95.0|-24.156|10.336||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||10.336|-24.156|0.4301
71848616|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.96|-0.48||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 12||-0.48|-0.96|< 0.0001
71848617|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.71|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.44||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 18||-0.44|-0.97|< 0.0001
71848618|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.53||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 24||-0.53|-1.06|< 0.0001
71848619|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.66||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 36||-0.66|-1.21|< 0.0001
71848620|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.99|||<|0.0001|TWO_SIDED|95.0|-1.28|-0.7||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 48||-0.70|-1.28|< 0.0001
71899475|NCT00570739|143321564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.5369|TWO_SIDED|95.0|-21.661|11.321||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||11.321|-21.661|0.5369
71816359|NCT02307513|143134952|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0112|TWO_SIDED|95.0|0.408|0.915|||Stratified Log Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors|||0.915|0.408|0.0112
71816360|NCT02307513|143134953|SUPERIORITY||Difference in LS Means|-0.4||||0.0683|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|ANCOVA model with treatment group, sex and region as factors and the baseline ulcers number as a covariate.||||0.0|-0.9|0.0683
71816361|NCT02307513|143134954|SUPERIORITY||Difference in LS Mean|-0.1||||0.5944|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||0.3|-0.4|0.5944
71816362|NCT02307513|143134955|SUPERIORITY||Difference in LS Mean|-5.5||||0.6182|TWO_SIDED|95.0|-27.6|16.7|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.||||16.7|-27.6|0.6182
71816363|NCT05952297|143134958|SUPERIORITY|||||||0.88|||||||mixed model|linear mixed model, time x condition effect||||||.88
71816364|NCT00744263|143134961|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.56||||0.0006|TWO_SIDED|95.2|21.82|62.49|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||62.49|21.82|0.0006
71848621|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.68||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 60||-0.68|-1.27|< 0.0001
71848622|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.64||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 72||-0.64|-1.22|< 0.0001
71816365|NCT00744263|143134962|SUPERIORITY_OR_OTHER||Vaccine Efficacy|45.0||||0.0067|TWO_SIDED|95.2|14.21|65.31|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||65.31|14.21|0.0067
71816366|NCT00744263|143134963|SUPERIORITY_OR_OTHER||Vaccine Efficacy|75.0||||0.0005|TWO_SIDED|95.0|41.43|90.78|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.||90.78|41.43|0.0005
71816367|NCT00744263|143134966|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.979
71816368|NCT00744263|143134967|SUPERIORITY_OR_OTHER|||||||0.455|TWO_SIDED||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.||||0.455
71816369|NCT05652036|143134985|OTHER|||||||0.21||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in NPS score pre- and post-procedure||||0.21
71848623|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.69||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 84||-0.69|-1.27|< 0.0001
71848624|NCT01377844|143211416|SUPERIORITY||Difference of LS Means|-1.02|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.73||The p-value is from a 2-sided t-test for the difference in means of change from baseline. Statistical significant is set at 0.05 level.|ANCOVA|Based on analysis of covariance, including treatment group, baseline HbA1c, site, age category, gender and race||Change from baseline in HbA1c (%) at Week 96||-0.73|-1.31|< 0.0001
71848625|NCT01377844|143211417|SUPERIORITY||Difference of LS Means|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.79|-1.7||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 2, between EGT0001442 and Placebo group.||-1.70|-2.79|< 0.0001
71848626|NCT01377844|143211417|SUPERIORITY||Difference of LS Means|-2.45|||<|0.0001|TWO_SIDED|95.0|-3.09|-1.81||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 6, between EGT0001442 and Placebo group.||-1.81|-3.09|< 0.0001
71816370|NCT05652036|143134986|OTHER|||||||0.07||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder symptom bother before and after treatment||||.07
71816371|NCT05652036|143134986|OTHER|||||||0.16||||||Threshold for statistical significance used P-value \<0.05|t-test, 2 sided|||Difference in overactive bladder HRQL mean before and after treatment||||0.16
71816372|NCT05652036|143134987|OTHER|||||||0.21|||||||Chi-squared|||Participant rated procedural satisfaction assessed 30-days post-procedure.||||0.21
71816373|NCT05652036|143134988|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as very much improved after treatment||||||0.79|||||||Chi-squared|||||||0.79
71816374|NCT05652036|143134988|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as much improved after treatment||||||0.27|||||||Chi-squared|||||||0.27
71816375|NCT05652036|143134988|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as minimally improved after treatment||||||0.14|||||||Chi-squared|||||||0.14
71816376|NCT05652036|143134988|OTHER|Clinical Global Impression of Improvement scale sores reported by participants as no difference after treatment||||||1|||||||Chi-squared|||||||1.0
71816377|NCT05652036|143134989|OTHER|Rates of urinary retention observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
71816378|NCT05652036|143134989|OTHER|Rates of urinary tract infection observed in participants after BTX-A treatment.||||||0.24|||||||Chi-squared|||||||0.24
71816379|NCT05652036|143134989|OTHER|Rates of bleeding requiring evaluation observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
71816380|NCT05652036|143134989|OTHER|Rates of hematuria observed in participants after BTX-A treatment.||||||0.46|||||||Chi-squared|||||||0.46
71816381|NCT05652036|143134989|OTHER|Rates of bladder pain observed in participants after BTX-A treatment.||||||1|||||||Chi-squared|||||||1.0
71816382|NCT05652036|143134989|OTHER|Rates of ER department evaluations observed in participants after BTX-A treatment.||||||0.5|||||||Chi-squared|||||||0.5
71816383|NCT05408468|143134996|SUPERIORITY||Mean Difference (Net)|-5.595|STANDARD_ERROR_OF_MEAN|1.731||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.731 One week 1.894|||||0.387
71816384|NCT05408468|143134996|SUPERIORITY||Mean Difference (Net)|-3.782|STANDARD_ERROR_OF_MEAN|2.048||0.387|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.048 One week 2.122|||||0.387
71848627|NCT01377844|143211417|SUPERIORITY||Difference of LS Means|-2.42|||<|0.0001|TWO_SIDED|95.0|-3.06|-1.77||The p-value is from a two-sided t-test for the difference in means of change from baseline|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 12, between EGT0001442 and Placebo group.||-1.77|-3.06|< 0.0001
71848628|NCT01377844|143211417|SUPERIORITY||Difference of LS Means|-2.71|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.11||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 18, between EGT0001442 and Placebo group.||-2.11|-3.30|< 0.0001
71816385|NCT05408468|143134997|SUPERIORITY||Mean Difference (Net)|-4.5|STANDARD_ERROR_OF_MEAN|1.693||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 1.693 One week 1.840|||||0.062
71816386|NCT05408468|143134997|SUPERIORITY||Mean Difference (Net)|-0.764|STANDARD_ERROR_OF_MEAN|2.003||0.062|TWO_SIDED||||||Mixed Models Analysis||Baseline 2.003 One week 2.069|||||0.062
71816387|NCT05408468|143134999|SUPERIORITY||Median Difference (Final Values)|2.58|STANDARD_ERROR_OF_MEAN|2.84||0.369|TWO_SIDED||||||t-test, 2 sided|||||||0.369
71816388|NCT05408468|143135000|SUPERIORITY||Median Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|3.79||0.498|TWO_SIDED||||||t-test, 2 sided|||||||0.498
71816389|NCT00405639|143135012|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71816390|NCT00405639|143135013|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71816391|NCT00405639|143135014|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
71816392|NCT00405639|143135015|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71816393|NCT01087996|143135038|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71899476|NCT00570739|143321565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.151||||0.7447|TWO_SIDED|95.0|-1.068|0.765||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.765|-1.068|0.7447
71899477|NCT00570739|143321565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.9476|TWO_SIDED|95.0|-0.853|0.911||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.911|-0.853|0.9476
71816394|NCT01087996|143135039|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||ANOVA|||||||0.75
71816395|NCT01087996|143135040|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71816396|NCT01087996|143135041|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71816397|NCT01087996|143135042|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71816398|NCT01087996|143135043|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71816399|NCT01087996|143135044|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Repeated measures ANOVA|||||||0.87
71816400|NCT01087996|143135045|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Repeated measures ANOVA|||||||0.84
71816401|NCT01087996|143135046|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Chi-squared|||||||0.55
71816402|NCT02066896|143135056|OTHER|ANOVA repeated measures||||||0.05|||||||ANOVA|ANOVA repeated measures||||||0.05
71816403|NCT05067933|143135073|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.953|||||||Wilcoxon rank sum tests|||||||0.953
71816404|NCT05067933|143135074|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.5|||||||Wilcoxon rank sum tests|||||||0.500
71816405|NCT05067933|143135075|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.912|||||||Wilcoxon rank sum tests|||||||0.912
71816406|NCT05067933|143135076|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.678|||||||Wilcoxon rank sum tests|||||||0.678
71816407|NCT05067933|143135077|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.257|||||||Wilcoxon rank sum tests|||||||0.257
71816408|NCT05067933|143135078|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.748|||||||Wilcoxon rank sum tests|||||||0.748
71816409|NCT05067933|143135079|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.946|||||||Wilcoxon rank sum tests|||||||0.946
71816410|NCT05067933|143135082|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.356|||||||Wilcoxon rank sum tests|||||||0.356
71816411|NCT05067933|143135083|OTHER|Comparison between immunogenicity assay results between treatment groups on Day 57.||||||0.267|||||||Wilcoxon rank sum tests|||||||0.267
71816412|NCT01065350|143135101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.001|TWO_SIDED|95.0|2.07|26.15||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.||26.15|2.07|<0.001
71679130|NCT02357706|142876220|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.205|TWO_SIDED||||||t-test, 1 sided|||||||0.205
71679131|NCT02357706|142876220|NON_INFERIORITY|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.134|TWO_SIDED||||||t-test, 1 sided|||||||0.134
71679132|NCT01895608|142876276|OTHER|non-parametric statistic: Mann-Whitney U test for independent samples||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.562
71679133|NCT01895608|142876276|OTHER|||||||0.414|||||||Wilcoxon (Mann-Whitney)|non-parametric statistical analysis: Mann Whitney U Test for independent samples||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.414
71679134|NCT01895608|142876277|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.181
71679135|NCT01895608|142876277|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||1.000
71679136|NCT01895608|142876278|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||1.000
71679137|NCT01895608|142876278|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.662|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.662
71679138|NCT01895608|142876279|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.05
71816413|NCT01065350|143135101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.24|||<|0.01|TWO_SIDED|95.0|1.21|8.75||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.||8.75|1.21|<0.01
71816414|NCT01065350|143135101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.39|TWO_SIDED|95.0|0.52|4.55||A p value of \< 0.005 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups||4.55|0.52|0.39
71899478|NCT00570739|143321566|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||<0.0001
71679139|NCT01895608|142876279|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.171|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.171
71816415|NCT01065350|143135102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.64|||<|0.01|TWO_SIDED|95.0|1.54|14.92||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.||14.92|1.54|<0.01
71816416|NCT01065350|143135102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.05|TWO_SIDED|95.0|0.91|6.29||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.||6.29|0.91|0.05
71816417|NCT01065350|143135102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74||||0.11|TWO_SIDED|95.0|0.68|13.19||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.||13.19|0.68|0.11
71899479|NCT00570739|143321566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.23||||0.0018|TWO_SIDED|95.0|2.06|13.58||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||13.58|2.06|0.0018
71899480|NCT00570739|143321566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.46||||0.0019|TWO_SIDED|95.0|1.89|10.54||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||10.54|1.89|0.0019
71899481|NCT00570739|143321566|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0005
71899482|NCT00570739|143321566|SUPERIORITY_OR_OTHER|||||||0.0007||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0007
71816418|NCT01065350|143135103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.12|||<|0.001|TWO_SIDED|95.0|1.98|31.64||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||31.64|1.98|<0.001
71816419|NCT01065350|143135103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.02|TWO_SIDED|95.0|1.07|7.65||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.||7.65|1.07|0.02
71816420|NCT01065350|143135103|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.33|TWO_SIDED|95.0|0.51|5.97||A p value of \< 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.||5.97|0.51|0.33
71816421|NCT01065350|143135104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.19|TWO_SIDED|95.0|-0.1|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.||0.5|-0.1|0.19
71816422|NCT01065350|143135104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.6|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.||0.5|-0.3|0.6
71848629|NCT01377844|143211417|SUPERIORITY||Difference of LS Means|-2.63|||<|0.0001|TWO_SIDED|95.0|-3.24|-2.02||The p-value is from a two-sided t-test for the difference in means of change from baseline.|ANCOVA|Based on analysis of covariance, including treatment group, baseline FPG, baseline HbA1c category, site, age category, gender and race||Difference of mean-adjusted change from baseline in FPG (mmol/L) at Week 24, between EGT0001442 and Placebo group.||-2.02|-3.24|< 0.0001
71848630|NCT02236611|143211424|NON_INFERIORITY_OR_EQUIVALENCE|Alternate hypothesis: the difference between the trt means (umeclidinium minus glycopyrronium) would be \> -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.|Mean Difference (Final Values)|0.024||||0.1|TWO_SIDED|95.0|-0.005|0.054|||Mixed Models Analysis|||||0.054|-0.005|0.100
71848631|NCT01686152|143211461|EQUIVALENCE|The test product was determined to be bioequivalent to the reference product if the 90% confidence interval was within -0.20 to 0.20.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|90.0|-0.0663|0.0913||||||||0.0913|-0.0663|
71848632|NCT00704340|143211470|SUPERIORITY_OR_OTHER|||||||0.613|||||||t-test, 2 sided|||The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.||||.613
71816423|NCT01065350|143135105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.26|TWO_SIDED|95.0|-0.1|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.||0.3|-0.1|0.26
71816424|NCT01065350|143135105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||0.3|-0.2|0.71
71816425|NCT01065350|143135106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.61|TWO_SIDED|95.0|-2.9|1.7|||t-test, 2 sided|||Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.||1.7|-2.9|0.61
71816426|NCT01065350|143135106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.22|TWO_SIDED|95.0|-4.8|1.1|||t-test, 2 sided|||Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.||1.1|-4.8|0.22
71816427|NCT01065350|143135107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.7|||<|0.001|TWO_SIDED|95.0|7.5|20.0|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||20.0|7.5|<0.001
71816428|NCT01065350|143135107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8||||0.017|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.017
71816429|NCT01065350|143135108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||<|0.01|TWO_SIDED|95.0|2.7|11.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.||11.5|2.7|<0.01
71848633|NCT00704340|143211471|SUPERIORITY_OR_OTHER|||||||0.681|||||||t-test, 2 sided|||||||.681
71848634|NCT00704340|143211472|SUPERIORITY_OR_OTHER|||||||0.619|||||||t-test, 2 sided|||||||.619
71848635|NCT01393600|143211507|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.3||0.588|TWO_SIDED|95.0|-3.3|1.9|||ANOVA|||||1.9|-3.3|0.5880
71848636|NCT01393600|143211507|OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.4184|TWO_SIDED|95.0|-3.8|1.6|||ANOVA|||||1.6|-3.8|0.4184
71816430|NCT01065350|143135108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.042|TWO_SIDED|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.||9.5|0.2|0.042
71848637|NCT01393600|143211509|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.0||0.6761|TWO_SIDED|95.0|-2.4|1.6|||ANOVA|||||1.6|-2.4|0.6761
71816431|NCT01065350|143135109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|||<|0.001|TWO_SIDED|95.0|4.8|13.9|||t-test, 2 sided|||Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.||13.9|4.8|<0.001
71816432|NCT01065350|143135109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3||||0.013|TWO_SIDED|95.0|1.4|11.3|||t-test, 2 sided|||Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.||11.3|1.4|0.013
71816433|NCT01065350|143135110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.6|||<|0.01|TWO_SIDED|95.0|28.1|199.1|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.||199.1|28.1|<0.01
71679140|NCT01895608|142876280|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.313|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.313
71679141|NCT01895608|142876280|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.852|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.852
71679142|NCT01895608|142876281|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.263|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.||||0.263
71679143|NCT01895608|142876281|OTHER|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.||||0.181
71679144|NCT01044290|142876292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|||<|0.61|TWO_SIDED|95.0|-1.1|0.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||.7|-1.1|<0.61
71679145|NCT01044290|142876292|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|||<|0.02|TWO_SIDED|95.0|0.2|2.0|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.0|.2|<.02
71679146|NCT01044290|142876293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|||=|0.9|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||1.1|-1.2|=.9
71848638|NCT01393600|143211509|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0015|TWO_SIDED|95.0|-6.6|-1.8|||ANOVA|||||-1.8|-6.6|0.0015
71848639|NCT00508183|143211516|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
71679147|NCT01044290|142876293|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02|||<|0.97|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks.||1.1|-1.2|<.97
71679148|NCT01044290|142876294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||<|0.91|TWO_SIDED|95.0|-1.4|1.5|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||1.5|-1.4|<.91
71816434|NCT01065350|143135110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.8||||0.12|TWO_SIDED|95.0|-21.7|195.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.||195.3|-21.7|0.12
71816435|NCT01065350|143135111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.6||||0.017|TWO_SIDED|95.0|33.8|331.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.||331.3|33.8|0.017
71816436|NCT01065350|143135111|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.7||||0.17|TWO_SIDED|95.0|-58.1|315.5|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.||315.5|-58.1|0.17
71848640|NCT00508183|143211517|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71848641|NCT00508183|143211518|OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71848642|NCT00508183|143211520|OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71679149|NCT01044290|142876294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||=|0.42|TWO_SIDED|95.0|-2.1|0.9|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks||0.9|-2.1|=.42
71679150|NCT01044290|142876295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|||=|0.58|TWO_SIDED|95.0|-1.5|2.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.8|-1.5|=.58
71679151|NCT01044290|142876295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04|||<|0.97|TWO_SIDED|95.0|-2.1|2.2|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.||2.2|-2.1|<.97
71816437|NCT01065350|143135112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.029|TWO_SIDED|95.0|0.5|8.4|||t-test, 2 sided|||Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.||8.4|0.5|0.029
71848643|NCT01762982|143211559|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0654||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0654
71848644|NCT01762982|143211562|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0078||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0078
71848645|NCT01762982|143211563|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0547||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.||||0.0547
71679152|NCT01044290|142876296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.6|2.4|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||2.4|-.6|.25
71679153|NCT01044290|142876296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED|95.0|0.05|3.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks||3.1|.05|<.05
71679154|NCT01044290|142876297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.57|TWO_SIDED|95.0|-1.0|1.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||1.8|-1.0|<.57
71679155|NCT01044290|142876297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|||=|0.055|TWO_SIDED|95.0|-0.03|2.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.||2.7|-0.03|=0.055
71816438|NCT01065350|143135112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.051|TWO_SIDED|95.0|0.0|9.7|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.||9.7|-0.0|0.051
71679156|NCT01646021|142876342|OTHER||Hazard Ratio (HR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.35|0.6|||Log Rank|||||0.60|0.35|< 0.0001
71679157|NCT01646021|142876344|SUPERIORITY||Hazard Ratio (HR)|0.74|||=|0.0621|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|= 0.0621
71848646|NCT01029704|143211576|SUPERIORITY||Difference of LS Means|-16.923||||0.0989|TWO_SIDED|95.0|-37.076|3.23||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.230|-37.076|0.0989
71848647|NCT01029704|143211576|SUPERIORITY||Difference of LS Means|-17.834||||0.0964|TWO_SIDED|95.0|-38.909|3.242||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||3.242|-38.909|0.0964
71848648|NCT01029704|143211576|SUPERIORITY||Difference of LS Means|-19.991||||0.0465|TWO_SIDED|95.0|-39.67|-0.312||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.312|-39.670|0.0465
71679158|NCT01663779|142876392|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.01|TWO_SIDED|95.0|3.0|7.0|||Chi-squared|||||7|3|<0.01
71679159|NCT01967706|142876402|OTHER||Geometric LS Mean Ratio|88.47|||||TWO_SIDED|95.0|68.64|114.03|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||114.03|68.64|
71816439|NCT01065350|143135113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.027|TWO_SIDED|95.0|0.3|4.7|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.||4.7|0.3|0.027
71816440|NCT01065350|143135113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.052|TWO_SIDED|95.0|0.0|5.2|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.||5.2|-0.0|0.052
71816441|NCT01065350|143135114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.44|TWO_SIDED|95.0|-1.4|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.||0.6|-1.4|0.44
71848649|NCT01029704|143211576|SUPERIORITY||Difference of LS Means|-32.01||||0.0015|TWO_SIDED|95.0|-51.487|-12.533||P-values are from two-sided test at 5% level|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-12.533|-51.487|0.0015
71848650|NCT01029704|143211578|SUPERIORITY||Difference of LS Means|-1.434||||0.0025|TWO_SIDED|95.0|-2.349|-0.52||P-values are from a two-sided test.|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.520|-2.349|0.0025
71848651|NCT01029704|143211578|SUPERIORITY||Difference of LS Means|-1.037||||0.0269|TWO_SIDED|95.0|-1.952|-0.122||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.122|-1.952|0.0269
71848652|NCT01029704|143211578|SUPERIORITY||Difference of LS Means|-2.054|||<|0.0001|TWO_SIDED|95.0|-2.938|-1.17||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-1.170|-2.938|< 0.0001
71848653|NCT01029704|143211578|SUPERIORITY||Difference of LS Means|-1.172||||0.009|TWO_SIDED|95.0|-2.044|-0.301||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.301|-2.044|0.0090
71848654|NCT01029704|143211579|SUPERIORITY||Difference of LS Means|-0.353||||0.0281|TWO_SIDED|95.0|-0.668|-0.039||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.039|-0.668|0.0281
71848655|NCT01029704|143211579|SUPERIORITY||Difference of LS Means|-0.155||||0.3215|TWO_SIDED|95.0|-0.464|0.154||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.154|-0.464|0.3215
71848656|NCT01029704|143211579|SUPERIORITY||Difference of LS Means|-0.004||||0.9776|TWO_SIDED|95.0|-0.304|0.295||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||0.295|-0.304|0.9776
71848657|NCT01029704|143211579|SUPERIORITY||Difference of LS Means|-0.344||||0.0242|TWO_SIDED|95.0|-0.642|-0.046||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||-0.046|-0.642|0.0242
71848658|NCT01029704|143211581|SUPERIORITY||Difference of LS Means|17.688||||0.1613|TWO_SIDED|95.0|-7.21|42.587||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||42.587|-7.210|0.1613
71899483|NCT00570739|143321567|SUPERIORITY_OR_OTHER|||||||0.0104||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.0104
71899484|NCT00570739|143321567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.2224|TWO_SIDED|95.0|0.53|9.39||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||9.39|0.53|0.2224
71899485|NCT00570739|143321567|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.199|TWO_SIDED|95.0|0.53|9.33||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||9.33|0.53|0.1990
71899486|NCT00570739|143321567|SUPERIORITY_OR_OTHER|||||||0.2778||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2778
71899487|NCT00570739|143321567|SUPERIORITY_OR_OTHER|||||||0.2785||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.2785
71899488|NCT00570739|143321568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.5353|TWO_SIDED|95.0|-2.84|1.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||1.48|-2.84|0.5353
71899489|NCT00570739|143321568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.5475|TWO_SIDED|95.0|-2.64|1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||1.40|-2.64|0.5475
71899490|NCT00570739|143321569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0116||||0.0678|TWO_SIDED|95.0|-0.0241|0.0009||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||0.0009|-0.0241|0.0678
71816442|NCT01065350|143135114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.37|TWO_SIDED|95.0|-1.6|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.||0.6|-1.6|0.37
71679160|NCT01967706|142876403|OTHER||Geometric LS Mean Ratio|98.13|||||TWO_SIDED|95.0|80.61|119.46|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||119.46|80.61|
71899491|NCT00570739|143321569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0112||||0.0585|TWO_SIDED|95.0|-0.0228|0.0004||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||0.0004|-0.0228|0.0585
71816443|NCT05879198|143135127|SUPERIORITY|||||||0.473|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.473
71816444|NCT05879198|143135128|SUPERIORITY|||||||0.469|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.469
71899492|NCT00570739|143321570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.7051|TWO_SIDED|95.0|-18.64|12.64||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks||12.64|-18.64|0.7051
71899493|NCT00570739|143321570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.5267|TWO_SIDED|95.0|-19.72|10.13||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||10.13|-19.72|0.5267
71899494|NCT00570739|143321571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.5882|TWO_SIDED|95.0|0.4|1.83||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.83|0.40|0.5882
71899495|NCT00570739|143321571|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.7098|TWO_SIDED|95.0|0.44|1.96||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.96|0.44|0.7098
71899496|NCT00570739|143321571|SUPERIORITY_OR_OTHER|||||||0.6835||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.6835
71899497|NCT00570739|143321571|SUPERIORITY_OR_OTHER|||||||0.8461||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.8461
71899498|NCT00570739|143321572|SUPERIORITY_OR_OTHER|||||||0.2079||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||0.2079
71899499|NCT00570739|143321572|SUPERIORITY_OR_OTHER|||||||0.4053||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4053
71816445|NCT05879198|143135129|SUPERIORITY|||||||0.155|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.155
71679161|NCT02347891|142876427|SUPERIORITY||Risk Ratio (RR)|0.5||||0.6|TWO_SIDED|95.0|0.08|2.65|||ANOVA|||Definition of Improvement (DOI) at week 40||2.65|0.08|0.60
71679162|NCT02347891|142876427|SUPERIORITY||Risk Ratio (RR)|0.6||||0.61|TWO_SIDED|95.0|0.16|1.82|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 40||1.82|0.16|0.61
71679163|NCT02347891|142876427|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 40||1.47|0|0.23
71816446|NCT05879198|143135130|SUPERIORITY|||||||0.346|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in total scale scores.||||.346
71816447|NCT05879198|143135132|SUPERIORITY|||||||0.075|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-positive scale scores.||||.075
71848659|NCT01029704|143211581|SUPERIORITY||Difference of LS Means|17.091||||0.2079|TWO_SIDED|95.0|-9.696|43.877||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||43.877|-9.696|0.2079
71848660|NCT01029704|143211581|SUPERIORITY||Difference of LS Means|24.379||||0.041|TWO_SIDED|95.0|1.028|47.731||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||47.731|1.028|0.0410
71848661|NCT01029704|143211581|SUPERIORITY||Difference of LS Means|20.749||||0.0862|TWO_SIDED|95.0|-3.019|44.518||P-values are from a two-sided test|ANCOVA|Analysis is based on ANCOVA with change from baseline as dependent variable and treatment as fixed effect and baseline and center as covariate.||||44.518|-3.019|0.0862
71848662|NCT00089791|143211583|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.32|||<|0.0001||95.0|0.26|0.41||Logistic regression was used to generate the p-value|Mantel Haenszel|||||0.41|0.26|<0.0001
71848663|NCT00089791|143211584|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.0106||95.0|0.67|0.95|||Regression, Cox|||||0.95|0.67|0.0106
71848664|NCT00089791|143211585|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.0362||95.0|0.37|0.97|||Regression, Cox|||||0.97|0.37|0.0362
71848665|NCT00721734|143211592|SUPERIORITY_OR_OTHER||Slope|-0.607||||0.4114|TWO_SIDED|95.0|-2.129|0.914|||Regression, Linear|||"In order to estimate a possible effect of renal function, the relationship between the clearance of carfilzomib and creatinine clearance (CrCl) was explored using a mixed-effects model that included CrCl.~The slope of the regression of CL as a function of CrCL at Cycle 1, Day 1 was evaluated using a linear regression model that included CrCL as continuous variables (excluding the hemodialysis group)."||0.914|-2.129|0.4114
71848666|NCT03989232|143211618|SUPERIORITY||Treatment difference|-0.23||||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||ANCOVA|||On-treatment without rescue medication observation period: Imputation of missing data was handled by multiple imputation (MI) assuming that missing data were missed at random (MAR). The imputation was performed separately within each treatment group defined by randomised treatment.||-0.11|-0.36|0.0003
71848667|NCT03989232|143211618|SUPERIORITY||Treatment difference|-0.18||||0.0098|TWO_SIDED|95.0|-0.31|-0.04|||ANCOVA|||In-trial observation period: Imputation of missing data was handled by MI assuming that missing data were missed at random. The imputation was performed by imputing missing week 40 data separately within groups defined by randomised treatment and treatment status at week 40.||-0.04|-0.31|0.0098
71848668|NCT03652610|143211639|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratio for serogroup A is \> 0.5|GMT ratio|0.88|||||TWO_SIDED|95.0|0.64|1.2|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) to that of currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted human serum bactericidal assay (hSBA) Geometric Mean Titers (GMTs) directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.20|0.64|
71848669|NCT03652610|143211640|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.84|1.68|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup C at Day 29||1.68|0.84|
71848670|NCT03652610|143211640|OTHER||GMT ratio|1.23|||||TWO_SIDED|95.0|0.96|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup W at Day 29||1.58|0.96|
71816448|NCT05879198|143135132|SUPERIORITY|||||||0.32|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in AEQ-negative scale scores.||||.320
71816449|NCT05879198|143135132|SUPERIORITY|||||||0.049|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-positive scale scores.||||.049
71899500|NCT00570739|143321572|SUPERIORITY_OR_OTHER|||||||0.5752||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.5752
71899501|NCT00570739|143321572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7994|TWO_SIDED|95.0|0.25|2.29||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||2.29|0.25|0.7994
71899502|NCT00570739|143321572|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.996|TWO_SIDED|95.0|0.32|3.03||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||3.03|0.32|0.9960
71899503|NCT00570739|143321572|SUPERIORITY_OR_OTHER|||||||0.7783||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.7783
71679164|NCT02347891|142876428|SUPERIORITY|||||||0.92|||||||ANOVA|||Mean Total Improvement Score (TIS) during Randomized Phase at Week 40||||0.92
71848671|NCT03652610|143211640|OTHER||GMT ratio|1.19|||||TWO_SIDED|95.0|0.9|1.58|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To compare the immunogenicity of the investigational MenACWY liquid vaccine with approximately 30% Men A FS (GSK3536820A ACWY\_Liq Group) and the currently licensed MenACWY vaccine (ACWY Group), as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup Y at Day 29||1.58|0.90|
71848672|NCT03652610|143211642|OTHER||Difference in percentage of subjects|-3.87|||||TWO_SIDED|95.0|-9.3|1.52|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||1.52|-9.30|
71848673|NCT03652610|143211642|OTHER||Difference in percentage of subjects|1.87|||||TWO_SIDED|95.0|-4.7|8.43|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||8.43|-4.70|
71848674|NCT03652610|143211642|OTHER||Difference in percentage of subjects|4.54|||||TWO_SIDED|95.0|-1.97|11.01|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||11.01|-1.97|
71848675|NCT03652610|143211642|OTHER||Difference in percentage of subjects|5.25|||||TWO_SIDED|95.0|-1.11|11.57|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||11.57|-1.11|
71848676|NCT03652610|143211643|OTHER||Difference in percentage of subjects|-2.47|||||TWO_SIDED|95.0|-6.47|1.49|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 1||1.49|-6.47|
71848677|NCT03652610|143211643|OTHER||Difference in percentage of subjects|-0.58|||||TWO_SIDED|95.0|-6.99|5.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 1||5.83|-6.99|
71848678|NCT03652610|143211643|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.33|0.47|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 1||0.47|-12.33|
71848679|NCT03652610|143211643|OTHER||Difference in percentage of subjects|-2.78|||||TWO_SIDED|95.0|-8.3|2.76|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 1||2.76|-8.30|
71848680|NCT03652610|143211643|OTHER||Difference in percentage of subjects|-3.69|||||TWO_SIDED|95.0|-8.65|1.21|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A at Day 29||1.21|-8.65|
71848681|NCT03652610|143211643|OTHER||Difference in percentage of subjects|-0.4|||||TWO_SIDED|95.0|-6.12|5.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C at Day 29||5.33|-6.12|
71848682|NCT03652610|143211643|OTHER||Difference in percentage of subjects|0.26|||||TWO_SIDED|95.0|-5.49|6.02|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W at Day 29||6.02|-5.49|
71848683|NCT03652610|143211643|OTHER||Difference in percentage of subjects|1.15|||||TWO_SIDED|95.0|-4.33|6.62|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y at Day 29||6.62|-4.33|
71848684|NCT03652610|143211644|OTHER||Difference in percentage of subjects|-2.91|||||TWO_SIDED|95.0|-7.24|1.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||1.37|-7.24|
71848685|NCT03652610|143211644|OTHER||Difference in percentage of subjects|-1.09|||||TWO_SIDED|95.0|-7.34|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||5.16|-7.34|
71848686|NCT03652610|143211644|OTHER||Difference in percentage of subjects|-5.95|||||TWO_SIDED|95.0|-12.35|0.5|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||0.50|-12.35|
71848687|NCT03652610|143211644|OTHER||Difference in percentage of subjects|-2.55|||||TWO_SIDED|95.0|-8.15|3.06|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||3.06|-8.15|
71848688|NCT03652610|143211644|OTHER||Difference in percentage of subjects|-3.92|||||TWO_SIDED|95.0|-8.87|0.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||0.96|-8.87|
71848689|NCT03652610|143211644|OTHER||Difference in percentage of subjects|0.07|||||TWO_SIDED|95.0|-5.52|5.65|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.65|-5.52|
71848690|NCT03652610|143211644|OTHER||Difference in percentage of subjects|-0.17|||||TWO_SIDED|95.0|-5.92|5.57|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||5.57|-5.92|
71848691|NCT03652610|143211644|OTHER||Difference in percentage of subjects|0.5|||||TWO_SIDED|95.0|-4.89|5.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.90|-4.89|
71848692|NCT01323790|143211657|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.188||||0.202|TWO_SIDED|95.0|0.911|1.548|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.548|0.911|0.202
71848693|NCT01323790|143211657|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.348||||0.021|TWO_SIDED|95.0|1.045|1.739|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.739|1.045|0.021
71679165|NCT02347891|142876429|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Definition of Improvement (DOI) at Week 64||1.47|0|0.23
71816450|NCT05879198|143135132|SUPERIORITY|||||||0.089|||||||t-test, 1 sided|||Paired samples, one-sided t-test comparing changes in MEEQ-negative scale scores.||||.089
71816451|NCT01693692|143135133|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.25||0.1683|ONE_SIDED|95.0||0.2|||ANCOVA|||||0.2||0.1683
71816452|NCT01693692|143135133|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.25||0.0277|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0277
71816453|NCT01693692|143135134|SUPERIORITY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|2.48||0.2637|ONE_SIDED|95.0||2.5|||ANCOVA|||||2.5||0.2637
71816454|NCT01693692|143135134|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|2.47||0.0097|ONE_SIDED|95.0||-1.7|||ANCOVA|||||-1.7||0.0097
71816455|NCT01693692|143135135|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16||0.0639|ONE_SIDED|95.0||0.0|||ANCOVA|||||0.0||0.0639
71816456|NCT01693692|143135135|SUPERIORITY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.007|ONE_SIDED|95.0||-0.1|||ANCOVA|||||-0.1||0.0070
71848694|NCT01323790|143211658|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.35||||0.074|TWO_SIDED|95.0|0.967|1.884||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||1.884|0.967|0.074
71679166|NCT02347891|142876429|SUPERIORITY||Risk Ratio (RR)|0.75||||0.99|TWO_SIDED|95.0|0.19|2.51|||ANOVA|||Percent patients reaching Total improvement score of ≥40 at Week 64||2.51|0.19|0.99
71679167|NCT02347891|142876429|SUPERIORITY||Risk Ratio (RR)|0.0||||0.23|TWO_SIDED|95.0|0.0|1.47|||ANOVA|||Percent of patient with major improvement TIS ≥60 at Week 64||1.47|0|0.23
71679168|NCT02347891|142876430|SUPERIORITY|||||||0.62|||||||ANOVA|||Mean Total Improvement Score (TIS) after Open Label Phase at 64 Week||||0.62
71679169|NCT05845567|142876431|SUPERIORITY||ratio of the Geometric LSmeans|139.43|||||TWO_SIDED|90.0|129.73|149.86||||||||149.86|129.73|
71679170|NCT05845567|142876432|SUPERIORITY||ratio of the Geometric LSmeans|117.97|||||TWO_SIDED|90.0|112.24|124.0||||||||124.00|112.24|
71816457|NCT00663117|143135136|SUPERIORITY_OR_OTHER|||||||0.009||||||The percentage of subjects achieving a 70-point drop in CDAI score in naltrexone treated subjects was the percentage acheiving the same drop in the placebo controls|Fisher Exact|||The proportion of those achieving a response with a 70-point decline in CDAI score was compared between naltrexone and placebo treated subjects using the Fisher's exact test. Analysis was performed with the intent-to-treat criteria. Clinical significance was accepted if the difference met 95% confidence (p\<0.05).||||0.009
71816458|NCT00663117|143135138|SUPERIORITY_OR_OTHER|||||||0.008|ONE_SIDED|95.0|||||Fisher Exact|||Percentage of patients having a 5-point decline in the endoscopic inflammation score||||0.008
71816459|NCT00663117|143135139|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 1 sided|||||||0.048
71816460|NCT03549234|143135140|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB (paravertebral block) using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||We hypothesized that 1) analgesia would be noninferior in the recovery room as measured on a Numeric Rating Scale with ESPB (erector spinae plane block), and 2) opioid consumption would be noninferior in the operating and recovery rooms with ESPB. We simulated pain scores from a discrete distribution with median (interquartile range) 2 (0-3). The sample size of 50 per group provided 81% power to detect noninferiority in pain.||||0.0011
71816461|NCT03549234|143135141|NON_INFERIORITY|"We tested the noninferiority of ESPB compared to PVB using the 95% confidence interval (CI) associated with the Wilcoxon-Mann-Whitney Exact test. If the lower limit of the 95% CI for median average recovery room pain scores was greater than -1.25 (based on PVB minus ESPB), we concluded noninferiority. The noninferiority of ESPBs with regard to opioid consumption was similarly tested with a predefined noninferiority margin of 2 mg intravenous morphine equivalents."||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||||||0.0043
71816462|NCT01265030|143135146|SUPERIORITY||Mean Difference (Net)|0.75||||0.63|TWO_SIDED|95.0|-2.54|4.04|||t-test, 2 sided|||||4.04|-2.54|0.63
71816463|NCT01265030|143135146|SUPERIORITY||Mean Difference (Net)|-1.95||||0.31|TWO_SIDED|95.0|-6.08|2.19|||t-test, 2 sided|||||2.19|-6.08|0.31
71816464|NCT01265030|143135147|SUPERIORITY||Mean Difference (Net)|0.063||||0.68|TWO_SIDED|95.0|-0.286|0.411|||t-test, 2 sided|||The mean difference in pain score at week 1 and before surgery||0.411|-.286|0.68
71848695|NCT01323790|143211658|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.489||||0.014|TWO_SIDED|95.0|1.078|2.058||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.058|1.078|0.014
71679171|NCT05845567|142876433|SUPERIORITY||ratio of the Geometric LSmeans|117.88|||||TWO_SIDED|90.0|112.13|123.92||||||||123.92|112.13|
71816465|NCT01590771|143135159|SUPERIORITY_OR_OTHER||Robust regression|-0.61|||<|0.001|TWO_SIDED|95.0|-0.77|-0.44||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.|ANCOVA||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.|||-0.44|-0.77|<0.001
71816466|NCT01590771|143135160|SUPERIORITY_OR_OTHER||Difference in least squares mean|-32.9|||<|0.001|TWO_SIDED|95.0|-45.4|-20.4||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.|ANCOVA|||||-20.4|-45.4|<0.001
71816467|NCT01590771|143135161|SUPERIORITY_OR_OTHER||Estimate difference|-16.8|||<|0.001|TWO_SIDED|95.0|-23.3|-10.2||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.|Robust regression|||||-10.2|-23.3|<0.001
71816468|NCT01590771|143135162|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.2||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.20|-0.63|<0.001
71816469|NCT01590771|143135163|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.07|-0.53||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA|||||-0.53|-1.07|<0.001
71679172|NCT03409107|142876449|SUPERIORITY||LS Mean Difference|1.4|||<|0.0001|TWO_SIDED|95.0|1.23|1.56|||ANCOVA|One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Treatment group comparisons were based on a ANCOVA model with terms for treatment, Baseline hemoglobin, and region.|||1.56|1.23|<0.0001
71679173|NCT03409107|142876450|SUPERIORITY||Difference in Response rate|0.56|||<|0.0001|TWO_SIDED|95.0|0.49|0.63||One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \<=0 versus alternative: difference \> 0|Cochran-Mantel-Haenszel||Treatment group comparisons were based on a Cochran-Mantel-Haenszel test adjusted for treatment group and region.|||0.63|0.49|<0.0001
71816470|NCT01590771|143135164|SUPERIORITY_OR_OTHER||Estimate difference|-27.2|||<|0.001|TWO_SIDED|95.0|-41.2|-13.2||Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.|Robust regression|||||-13.2|-41.2|<0.001
71679174|NCT03409107|142876451|SUPERIORITY||LS Mean Difference|5.36||||0.0005|TWO_SIDED|95.0|2.17|8.56||One-sided p-value based on test of null hypothesis:(Daprodustat-Placebo) \<= 0 vs alternative: difference \> 0.|ANCOVA||Treatment group comparisons were based on ANCOVA model with terms for treatment, Baseline score, and region.|||8.56|2.17|0.0005
71679175|NCT03409107|142876452|SUPERIORITY||Difference in Response rate|0.45|||<|0.0001|TWO_SIDED|95.0|0.37|0.52||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|Cochran-Mantel-Haenszel||Treatment group comparisons are based on a Cochran-Mantel-Haenszel test adjusted for treatment group, and region|||0.52|0.37|<0.0001
71679176|NCT03409107|142876453|SUPERIORITY||Difference in treatment effect|38.8|||||TWO_SIDED|95.0|25.0|54.55|||Hodges-Lehmann Estimate|Hodges-Lehmann Estimate of treatment difference has been reported.||||54.55|25.00|
71679177|NCT03409107|142876454|SUPERIORITY||Difference in treatment effect|0.768|||<|0.0001|TWO_SIDED|95.0|0.729|0.806||One-sided superiority p-value from the van Elteren test|van Elteren test||Mann-Whitney estimate of the treatment difference stratified by region has been presented.|||0.806|0.729|<0.0001
71679178|NCT03409107|142876455|SUPERIORITY||LS Mean difference|1.36|||<|0.0001|TWO_SIDED|95.0|1.16|1.55||One-sided superiority p-value from the MMRM model|MMRM||Treatment group comparisons were based on MMRM fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline Hb and Baseline Hb by time and treatment by time interactions.|||1.55|1.16|<0.0001
71679179|NCT03409107|142876456|SUPERIORITY||Hazard Ratio (HR)|0.07||||0.0002|TWO_SIDED|95.0|0.02|0.3||One-sided p-value was based on Wald test of null hypothesis: (Daprodustat/Placebo) \>=1 versus alternative: ratio\<1.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group and region.|||0.30|0.02|0.0002
71816471|NCT01590771|143135165|SUPERIORITY_OR_OTHER||Difference in least squares mean|-37.7|||<|0.001|TWO_SIDED|95.0|-56.9|-18.4||The ANCOVA model controlled for treatment and baseline 2-hr PMG value.|ANCOVA|||||-18.4|-56.9|<0.001
71816472|NCT01590771|143135166|SUPERIORITY_OR_OTHER||Estimate Difference|-16.5|||<|0.001|TWO_SIDED|95.0|-25.3|-7.8||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.8|-25.3|<0.001
71848696|NCT01323790|143211660|SUPERIORITY_OR_OTHER||LS mean difference|0.39||||0.01|TWO_SIDED|95.0|0.09|0.69|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.69|0.09|0.010
71679180|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|5.91|||<|0.0001|TWO_SIDED|95.0|2.83|9.0||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Tired/Low Energy/Weak domain.|||9.00|2.83|<0.0001
71679181|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|2.93||||0.0152|TWO_SIDED|95.0|0.28|5.57||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Chest Pain/Shortness of Breath Domain.|||5.57|0.28|0.0152
71679182|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|3.79||||0.0045|TWO_SIDED|95.0|0.95|6.63||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Cognitive Domain.|||6.63|0.95|0.0045
71816473|NCT01590771|143135167|SUPERIORITY_OR_OTHER||Estimate Difference|-17.0|||<|0.001|TWO_SIDED|95.0|-26.9|-7.1||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression|||||-7.1|-26.9|<0.001
71816474|NCT02019563|143135174|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.49|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.49|.08|.15
71816475|NCT02019563|143135175|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.38|TWO_SIDED|95.0|0.19|1.89|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.||1.89|.19|.38
71816476|NCT02019563|143135176|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.51
71848697|NCT01323790|143211660|SUPERIORITY_OR_OTHER||Ls mean difference|0.68|||<|0.001|TWO_SIDED|95.0|0.37|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.37|<0.001
71899504|NCT00570739|143321572|SUPERIORITY_OR_OTHER|||||||0.9774||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.9774
71899505|NCT00570739|143321573|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks||||<0.0001
71679183|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|2.61||||0.1267|TWO_SIDED|95.0|-1.87|7.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Sleeping|||7.09|-1.87|0.1267
71679184|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|4.64||||0.0203|TWO_SIDED|95.0|0.2|9.09||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Difficulty Standing for Long Periods of Time|||9.09|0.20|0.0203
71679185|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|2.68||||0.0266|TWO_SIDED|95.0|-0.04|5.39||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Severity of Shortness of Breath While Sitting or Resting|||5.39|-0.04|0.0266
71679186|NCT03409107|142876457|SUPERIORITY||Mean Difference (Net)|2.01||||0.0907|TWO_SIDED|95.0|-0.94|4.96||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||Analysis was performed by MMRM with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Time with Shortness of Breath While not Doing an Activity|||4.96|-0.94|0.0907
71679187|NCT03409107|142876458|SUPERIORITY||Mean Difference (Net)|-0.13||||0.0391|TWO_SIDED|95.0|-0.28|0.02||One-sided p-value was based on test of null hypothesis: (Daprodustat-rhEPO) \>=0 versus alternative: difference \<0|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.02|-0.28|0.0391
71679188|NCT03409107|142876459|SUPERIORITY||Mean Difference (Net)|2.57||||0.0858|TWO_SIDED|95.0|-1.12|6.26||One sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||6.26|-1.12|0.0858
71679189|NCT03409107|142876460|SUPERIORITY||Mean Difference (Net)|0.17||||0.0357|TWO_SIDED|95.0|-0.02|0.36||One sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel full of life?.|||0.36|-0.02|0.0357
71816477|NCT02019563|143135177|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.||||.64
71816478|NCT02019563|143135178|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The p-value represents the survival rate from the Kaplan-Meier survival analysis from 6 to 36 months.|Log Rank|||||||.11
71816479|NCT04022889|143135189|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|7.7|||TWO_SIDED|95.0|-3.5|6.2|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||6.2|-3.5|
71816480|NCT04022889|143135189|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|8.9|||TWO_SIDED|95.0|-6.4|4.8|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||4.8|-6.4|
71816481|NCT04022889|143135189|OTHER|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|10.2|||TWO_SIDED|95.0|-5.0|8.7|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||8.7|-5.0|
71816482|NCT04022889|143135189|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|-2.5|2.6|||||The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).|||2.6|-2.5|
71848698|NCT01323790|143211661|SUPERIORITY_OR_OTHER||LS mean difference|-0.19||||0.005|TWO_SIDED|95.0|-0.32|-0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.06|-0.32|0.005
71816483|NCT04022889|143135190|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|28.9|STANDARD_DEVIATION|16.5|||TWO_SIDED|95.0|18.5|39.4|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||39.4|18.5|
71848699|NCT01323790|143211661|SUPERIORITY_OR_OTHER||LS mean difference|-0.32|||<|0.001|TWO_SIDED|95.0|-0.45|-0.18|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.18|-0.45|<0.001
71899506|NCT00570739|143321573|SUPERIORITY_OR_OTHER|||||||0.4058||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks||||0.4058
71899507|NCT00570739|143321573|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks||||0.0254
71899508|NCT00570739|143321573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1499|TWO_SIDED|95.0|0.74|3.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||3.55|0.74|0.1499
71679190|NCT03409107|142876460|SUPERIORITY||Mean Difference (Net)|0.17||||0.0328|TWO_SIDED|95.0|-0.01|0.35||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you have a lot of energy?.|||0.35|-0.01|0.0328
71816484|NCT04022889|143135190|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|25.5|STANDARD_DEVIATION|25.3|||TWO_SIDED|95.0|9.5|41.6|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||41.6|9.5|
71816485|NCT04022889|143135190|EQUIVALENCE|Variant 1-BEST = Test Variant 1 Endpoint - Test BEST Endpoint|Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|21.3|||TWO_SIDED|95.0|-12.7|15.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||15.8|-12.7|
71816486|NCT04022889|143135190|NON_INFERIORITY|The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 × Control) was greater than or equal to zero.|Mean Difference (Final Values)|29.8|STANDARD_DEVIATION|18.5|||TWO_SIDED|95.0|21.8|37.8|||||The mean treatment difference is defined as Test survival - (0.58 × Control survival).|||37.8|21.8|
71816487|NCT00856934|143135236|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71816488|NCT00856934|143135237|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71848700|NCT01323790|143211662|SUPERIORITY_OR_OTHER||LS mean difference|0.28||||0.001|TWO_SIDED|95.0|0.12|0.45|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.45|0.12|0.001
71848701|NCT01323790|143211662|SUPERIORITY_OR_OTHER||LS mean difference|0.45|||<|0.001|TWO_SIDED|95.0|0.29|0.62|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.62|0.29|<0.001
71816489|NCT03285295|143135250|SUPERIORITY||Clinical Specificity (%)|99.96|||||TWO_SIDED|95.0|99.92|99.99|||Binomial Distribution|Specificity sample size is a minimum of 15,000 donors.||||99.99|99.92|
71816490|NCT03285295|143135251|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.15|100.0|||Sensitivity|||||100.00|99.15|
71816491|NCT03285295|143135252|SUPERIORITY||Clinical Specificity (%)|99.99|||||TWO_SIDED|95.0|99.95|100.0|||Binomial Distribution|||||100.00|99.95|
71816492|NCT03285295|143135253|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.48|100.0|||Sensitivity|||||100.00|99.48|
71816493|NCT03285295|143135254|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.86|99.95|||Binomial Distribution|||||99.95|99.86|
71816494|NCT03285295|143135255|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
71816495|NCT03285295|143135256|SUPERIORITY||Clinical Specificity (%)|99.92|||||TWO_SIDED|95.0|99.87|99.96|||Binomial Exact|||||99.96|99.87|
71816496|NCT03285295|143135257|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.72|100.0|||Sensitivity|||||100.00|99.72|
71816497|NCT03285295|143135258|SUPERIORITY||Clinical Specificity (%)|99.9|||||TWO_SIDED|95.0|99.84|99.94|||Binomial Exact|||||99.94|99.84|
71816498|NCT03285295|143135259|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|99.09|100.0|||Sensitivity|||||100.00|99.09|
71816499|NCT03285295|143135260|SUPERIORITY||Clinical Specificity (%)|99.98|||||TWO_SIDED|95.0|99.94|100.0|||Binomial Exact|||||100.00|99.94|
71816500|NCT03285295|143135261|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|98.85|100.0|||Sensitivity|||||100.00|98.85|
71816501|NCT03285295|143135266|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|95.98|100.0|||Sensitivity|||Sensitivity||100.00|95.98|
71816502|NCT03285295|143135268|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|92.75|100.0|||Sensitivity|||Sensitivity||100.00|92.75|
71816503|NCT03285295|143135269|OTHER|95% Confidence Interval provided.|Point Estimate|100.0|||||TWO_SIDED|95.0|94.87|100.0|||Sensitivity|||Sensitivity||100.00|94.87|
71848702|NCT01323790|143211663|SUPERIORITY_OR_OTHER||LS mean difference|6.72||||0.002|TWO_SIDED|95.0|2.37|11.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||11.06|2.37|0.002
71848703|NCT01323790|143211663|SUPERIORITY_OR_OTHER||LS mean difference|10.43|||<|0.001|TWO_SIDED|95.0|6.03|14.84|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||14.84|6.03|<0.001
71899509|NCT00570739|143321573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.042|TWO_SIDED|95.0|0.97|4.45||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||4.45|0.97|0.0420
71679191|NCT03409107|142876460|SUPERIORITY||Mean Difference (Net)|0.18||||0.0252|TWO_SIDED|95.0|0.0|0.37||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel worn out?.|||0.37|0.00|0.0252
71679192|NCT03409107|142876460|SUPERIORITY||Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.1|0.42||One-sided p-value based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus alternative: difference \>0.|MMRM||MMRM fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions for Did you feel tired?.|||0.42|0.10|0.0010
71679193|NCT03409107|142876467|SUPERIORITY||Mean Difference (Net)|0.03||||0.1098|TWO_SIDED|95.0|-0.02|0.07||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 versus. alternative: difference \>0.|MMRM||Based on MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.07|-0.02|0.1098
71679194|NCT03409107|142876468|SUPERIORITY||Mean Difference (Net)|4.5||||0.012|TWO_SIDED|95.0|0.6|8.4||One-sided p-value was based on test of null hypothesis: (Daprodustat-Placebo) \<=0 vs. alternative: difference \>0.|MMRM||MMRM model fitted from Baseline up to Week 28 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.|||8.40|0.60|0.0120
71679195|NCT03409107|142876469|SUPERIORITY||Mean Difference (Net)|0.4||||0.6106|TWO_SIDED|95.0|-2.42|3.22||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline SBP and Baseline SBP by time and treatment by time interactions.|||3.22|-2.42|0.6106
71679196|NCT03409107|142876469|SUPERIORITY||Mean Difference (Net)|1.8||||0.9819|TWO_SIDED|95.0|0.12|3.49||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \< 0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline DBP and Baseline DBP by time and treatment by time interactions.|||3.49|0.12|0.9819
71679197|NCT03409107|142876469|SUPERIORITY||Mean Difference (Net)|1.31||||0.9215|TWO_SIDED|95.0|-0.51|3.13||"One-sided p-value was based on test of null hypothesis: (Daprodustat - Placebo) \>= 0 versus alternative:~difference \<0"|MMRM||MMRM model fitted from Baseline up to Week 28, with factors for treatment, time, region, Baseline MAP and Baseline MAP by time and treatment by time interactions.|||3.13|-0.51|0.9215
71679198|NCT03409107|142876470|SUPERIORITY||Difference in Response rate|0.06||||0.068|TWO_SIDED|95.0|-0.02|0.13||One-sided p-value based on test of null hypothesis: (Daprodustat - Placebo) \<= 0 versus alternative: difference \> 0.|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test was performed for treatment group comparison.|||0.13|-0.02|0.0680
71679199|NCT05010512|142876471|NON_INFERIORITY|Noninferiority in distance VA was declared if the least squares means difference upper confidence limit was less than 0.05.|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with terms for lens, period and sequence as fixed effects, subject as a random effect. Difference = DT1 minus Infuse|||0.01||
71816504|NCT03285295|143135270|OTHER|95% Confidence Interval provided.|Point Estimate|98.65|||||TWO_SIDED|95.0|95.2|99.84|||Sensitivity|||Sensitivity||99.84|95.20|
71816505|NCT01015807|143135276|OTHER|||||||0.48|||||||ANOVA|||We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed \[alpha\] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)||||0.48
71848704|NCT01323790|143211664|SUPERIORITY_OR_OTHER||LS mean difference|0.52||||0.028|TWO_SIDED|95.0|0.06|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.98|0.06|0.028
71899510|NCT00570739|143321573|SUPERIORITY_OR_OTHER|||||||0.224||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2240
71899511|NCT00570739|143321573|SUPERIORITY_OR_OTHER|||||||0.0593||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.0593
71816506|NCT00930943|143135311|SUPERIORITY||||||<|0.001||||||repeated-measure ANOVA tested time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||The a priori sample-size estimation for a power of 80% with alpha = 0.05 was based on the primary-outcome measure, the rapid visual information processing (RVP) sensitivity (A') score. Using a repeated-measure ANOVA for the food effect (fed versus fasting) and assuming an effect size of f =0.26 generated a required sample size of 32 participants. However, only 30 subjects completed both testing visits, generating a power of 78.2%.|(F\[1,28\] = 22.71; η2 = 0.45)|||<0.001
71816507|NCT00930943|143135311|SUPERIORITY|||||||0.01||||||repeated-measure ANOVA tested food x time-post-dose effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA||||F\[1,28\]=6.88; η2=0.20|||0.01
71816508|NCT00930943|143135311|SUPERIORITY||||||>|0.05||||||repeated-measure ANOVA testing food effect for Rapid Visual Information Processing (RVP): sensitivity (A')|ANOVA|||||||>0.05
71848705|NCT01323790|143211664|SUPERIORITY_OR_OTHER||LS mean difference|1.04|||<|0.001|TWO_SIDED|95.0|0.58|1.51|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.51|0.58|<0.001
71848706|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.08|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.080
71816509|NCT00930943|143135312|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Rapid Visual Information Processing (RVP): response latency|ANOVA||||(F\[1,28\] = 14.05; η2 = 0.33)|||<0.001
71816510|NCT00930943|143135312|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time post dose effect for Rapid Visual Information Processing (RVP): response latency"|ANOVA|||||||>0.05
71816511|NCT00930943|143135313|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SRM percentage of correct hits"|ANOVA|||||||>0.05
71816512|NCT00930943|143135314|SUPERIORITY||||||<|0.001||||||Repeated-measure ANOVA testing time-post-dose effect for Spatial Recognition Memory (SRM) response latency|ANOVA||||(F\[1,28\] = 31.26; η2 = 0.53)|||<0.001
71848707|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.011|TWO_SIDED|95.0|-0.32|-0.04||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.04|-0.32|0.011
71816513|NCT00930943|143135314|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food and food x time-post-dose effect for SRM response latency"|ANOVA|||||||>0.05
71816514|NCT00930943|143135315|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM total errors"|ANOVA|||||||>0.05
71848708|NCT01323790|143211666|SUPERIORITY_OR_OTHER||Slope|0.05||||0.552|TWO_SIDED|95.0|-0.11|0.2||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.20|-0.11|0.552
71848709|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.236|TWO_SIDED|95.0|-0.06|0.25||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.25|-0.06|0.236
71816515|NCT00930943|143135316|SUPERIORITY||||||>|0.05||||||"repeated-measure ANOVA testing food, time-post-dose, and food x time-post-dose effect for SWM strategy score"|ANOVA|||||||>0.05
71816516|NCT00612534|143135321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.26|STANDARD_ERROR_OF_MEAN|7.83||0.194||95.0|-5.32|25.83|||ANCOVA|||||25.83|-5.32|0.194
71816517|NCT00612534|143135321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|STANDARD_ERROR_OF_MEAN|7.77||0.268|TWO_SIDED|95.0|-6.78|24.11|||ANCOVA|||||24.11|-6.78|0.268
71848710|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.095|TWO_SIDED|95.0|-0.24|0.02||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.24|0.095
71816518|NCT00612534|143135321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.05|STANDARD_ERROR_OF_MEAN|8.3||0.018|TWO_SIDED|95.0|3.54|36.56|||ANCOVA|||||36.56|3.54|0.018
71816519|NCT01008475|143135331|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.78|1.64||||||||1.64|0.78|
71816520|NCT01008475|143135331|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.77|1.61||||||||1.61|0.77|
71816521|NCT01008475|143135332|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.54|1.28||||||||1.28|0.54|
71848711|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.1||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.37|<0.001
71848712|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|-0.27||||0.002|TWO_SIDED|95.0|-0.44|-0.1||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.10|-0.44|0.002
71848713|NCT01323790|143211666|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|||<|0.001|TWO_SIDED|95.0|-0.56|-0.21||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.21|-0.56|<0.001
71848714|NCT01323790|143211667|SUPERIORITY_OR_OTHER||LS mean difference|-0.31||||0.011|TWO_SIDED|95.0|-0.54|-0.07|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.54|0.011
71848715|NCT01323790|143211667|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|||<|0.001|TWO_SIDED|95.0|-0.73|-0.25|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.25|-0.73|<0.001
71848716|NCT01263496|143211678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|||||TWO_SIDED|95.0|-0.618|-0.184||||||||-0.184|-0.618|
71848717|NCT01263496|143211678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.548|||||TWO_SIDED|95.0|-0.739|-0.358||||||||-0.358|-0.739|
71848718|NCT01263496|143211678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-0.779|-0.401||||||||-0.401|-0.779|
71848719|NCT01263496|143211678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.708|||||TWO_SIDED|95.0|-0.894|-0.522||||||||-0.522|-0.894|
71848720|NCT01263496|143211679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-0.538|-0.093||||||||-0.093|-0.538|
71848721|NCT01263496|143211679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.493|||||TWO_SIDED|95.0|-0.684|-0.302||||||||-0.302|-0.684|
71848722|NCT01263496|143211679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|||||TWO_SIDED|95.0|-0.706|-0.314||||||||-0.314|-0.706|
71848723|NCT01263496|143211679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.647|||||TWO_SIDED|95.0|-0.834|-0.461||||||||-0.461|-0.834|
71848724|NCT01263496|143211680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|||||TWO_SIDED|95.0|-0.479|-0.047||||||||-0.047|-0.479|
71848725|NCT01263496|143211680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|||||TWO_SIDED|95.0|-0.598|-0.192||||||||-0.192|-0.598|
71848726|NCT01263496|143211680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.405|||||TWO_SIDED|95.0|-0.616|-0.195||||||||-0.195|-0.616|
71848727|NCT01263496|143211680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.583|||||TWO_SIDED|95.0|-0.78|-0.386||||||||-0.386|-0.780|
71848728|NCT01263496|143211681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172|||||TWO_SIDED|95.0|-0.41|0.065||||||||0.065|-0.410|
71848729|NCT01263496|143211681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|||||TWO_SIDED|95.0|-0.55|-0.088||||||||-0.088|-0.550|
71848730|NCT01263496|143211681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|||||TWO_SIDED|95.0|-0.601|-0.139||||||||-0.139|-0.601|
71848731|NCT01263496|143211681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|||||TWO_SIDED|95.0|-0.752|-0.314||||||||-0.314|-0.752|
71848732|NCT01263496|143211682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.079|||||TWO_SIDED|95.0|-0.323|0.166||||||||0.166|-0.323|
71848733|NCT01263496|143211682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.241|||||TWO_SIDED|95.0|-0.471|-0.011||||||||-0.011|-0.471|
71848734|NCT01263496|143211682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.357|||||TWO_SIDED|95.0|-0.59|-0.124||||||||-0.124|-0.590|
71848735|NCT01263496|143211682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.467|||||TWO_SIDED|95.0|-0.692|-0.242||||||||-0.242|-0.692|
71848736|NCT01263496|143211683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|||||TWO_SIDED|95.0|-0.321|0.162||||||||0.162|-0.321|
71848737|NCT01263496|143211683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.294|||||TWO_SIDED|95.0|-0.542|-0.046||||||||-0.046|-0.542|
71848738|NCT01263496|143211683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.341|||||TWO_SIDED|95.0|-0.579|-0.103||||||||-0.103|-0.579|
71848739|NCT01263496|143211683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.487|||||TWO_SIDED|95.0|-0.722|-0.252||||||||-0.252|-0.722|
71848740|NCT01263496|143211684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.279|0.182||||||||0.182|-0.279|
71848741|NCT01263496|143211684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.234|||||TWO_SIDED|95.0|-0.491|0.023||||||||0.023|-0.491|
71848742|NCT01263496|143211684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.375|||||TWO_SIDED|95.0|-0.605|-0.145||||||||-0.145|-0.605|
71848743|NCT01263496|143211684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.488|||||TWO_SIDED|95.0|-0.724|-0.252||||||||-0.252|-0.724|
71848744|NCT01263496|143211685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.27|0.169||||||||0.169|-0.270|
71848745|NCT01263496|143211685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|||||TWO_SIDED|95.0|-0.453|0.067||||||||0.067|-0.453|
71848746|NCT01263496|143211685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.374|||||TWO_SIDED|95.0|-0.596|-0.152||||||||-0.152|-0.596|
71848747|NCT01263496|143211685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.723|-0.256||||||||-0.256|-0.723|
71848748|NCT01263496|143211686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|||||TWO_SIDED|95.0|-0.16|0.289||||||||0.289|-0.160|
71848749|NCT01263496|143211686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.236|||||TWO_SIDED|95.0|-0.477|0.005||||||||0.005|-0.477|
71848750|NCT01263496|143211686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-0.608|-0.113||||||||-0.113|-0.608|
71848751|NCT01263496|143211686|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.435|||||TWO_SIDED|95.0|-0.679|-0.191||||||||-0.191|-0.679|
71848752|NCT01263496|143211687|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|||||TWO_SIDED|95.0|-0.262|0.196||||||||0.196|-0.262|
71848753|NCT01263496|143211687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.262|||||TWO_SIDED|95.0|-0.516|-0.008||||||||-0.008|-0.516|
71848754|NCT01263496|143211687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.358|||||TWO_SIDED|95.0|-0.614|-0.103||||||||-0.103|-0.614|
71848755|NCT01263496|143211687|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.432|||||TWO_SIDED|95.0|-0.69|-0.174||||||||-0.174|-0.690|
71848756|NCT01263496|143211688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.118|||||TWO_SIDED|95.0|-0.346|0.11||||||||0.110|-0.346|
71848757|NCT01263496|143211688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277|||||TWO_SIDED|95.0|-0.539|-0.015||||||||-0.015|-0.539|
71848758|NCT01263496|143211688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373|||||TWO_SIDED|95.0|-0.637|-0.109||||||||-0.109|-0.637|
71848759|NCT01263496|143211688|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.477|||||TWO_SIDED|95.0|-0.741|-0.213||||||||-0.213|-0.741|
71848760|NCT01263496|143211689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|||||TWO_SIDED|95.0|-0.416|0.055||||||||0.055|-0.416|
71848761|NCT01263496|143211689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.245|||||TWO_SIDED|95.0|-0.492|0.003||||||||0.003|-0.492|
71848762|NCT01263496|143211689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.408|||||TWO_SIDED|95.0|-0.654|-0.161||||||||-0.161|-0.654|
71848763|NCT01263496|143211689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.638|||||TWO_SIDED|95.0|-0.874|-0.402||||||||-0.402|-0.874|
71848764|NCT01263496|143211690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.51|||||TWO_SIDED|95.0|-17.56|0.54||||||||0.54|-17.56|
71848765|NCT01263496|143211690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|||||TWO_SIDED|95.0|-19.23|-4.18||||||||-4.18|-19.23|
71848766|NCT01263496|143211690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||||TWO_SIDED|95.0|-20.68|-6.15||||||||-6.15|-20.68|
71848767|NCT01263496|143211690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.38|||||TWO_SIDED|95.0|-26.93|-11.83||||||||-11.83|-26.93|
71848768|NCT01263496|143211691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-12.67|3.8||||||||3.80|-12.67|
71679200|NCT02122770|142876541|SUPERIORITY||Geometric LS Mean Ratio|98.75|||||TWO_SIDED|90.0|82.6|118.05||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric least square (LS) means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.05|82.60|
71816522|NCT01008475|143135332|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||||TWO_SIDED|95.0|0.52|1.25||||||||1.25|0.52|
71816523|NCT01008475|143135333|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
71848769|NCT01263496|143211691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.39|||||TWO_SIDED|95.0|-17.48|-1.3||||||||-1.30|-17.48|
71816524|NCT01008475|143135333|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||||1.65|0.75|
71816525|NCT01008475|143135335|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95|||||TWO_SIDED|95.0|0.67|1.34||||||||1.34|0.67|
71816526|NCT01008475|143135335|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.74|1.48||||||||1.48|0.74|
71816527|NCT03556358|143135336|EQUIVALENCE|"Two one-sided hypothesis tests were performed for pCR in order to show that TX05 is equivalent to Herceptin:~* TEST 1: H0a: θ1 / θ2 \> 1.325 vs. H1a: θ1 / θ2 \< 1.325~* TEST 2: H0b: θ1 / θ2 \< 0.755 vs. H1b: θ1 / θ2 \> 0.755~Where θ1 is the proportion of pCR for subjects randomized to TX05 group, θ2 is the proportion of pCR for subjects randomized to Herceptin. Equivalence was concluded if the 95% CI of the risk ratio is completely contained within the pre-defined interval \[0.755, 1.325\]."|Risk Ratio (RR)|1.0783|||||TWO_SIDED|95.0|0.9185|1.2659||||||||1.2659|0.9185|
71816528|NCT04195880|143135342|SUPERIORITY||||||<|0.05|TWO_SIDED|5.0|||||negative-binomial regression coefficient|||We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.||||<.05
71816529|NCT01351025|143135353|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 IL-6||||0.94
71848770|NCT01263496|143211691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.56|||||TWO_SIDED|95.0|-18.58|-2.54||||||||-2.54|-18.58|
71848771|NCT01263496|143211691|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||||TWO_SIDED|95.0|-21.44|-3.31||||||||-3.31|-21.44|
71848772|NCT01263496|143211692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.9|||||TWO_SIDED|95.0|-15.66|1.86||||||||1.86|-15.66|
71848773|NCT01263496|143211692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.73|||||TWO_SIDED|95.0|-18.97|-2.49||||||||-2.49|-18.97|
71816530|NCT01351025|143135354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sun test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD4+ T-cell activation percent (% CD38+/DR+ of CD4)||||0.495
71848774|NCT01263496|143211692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.21|||||TWO_SIDED|95.0|-17.2|-1.23||||||||-1.23|-17.20|
71848775|NCT01263496|143211692|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.49|||||TWO_SIDED|95.0|-24.27|-6.72||||||||-6.72|-24.27|
71848776|NCT01263496|143211693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.27|||||TWO_SIDED|95.0|-11.22|6.67||||||||6.67|-11.22|
71848777|NCT01263496|143211693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.36|||||TWO_SIDED|95.0|-12.16|5.44||||||||5.44|-12.16|
71848778|NCT01263496|143211693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||||TWO_SIDED|95.0|-13.3|2.44||||||||2.44|-13.30|
71848779|NCT01263496|143211693|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.9|||||TWO_SIDED|95.0|-20.74|-3.06||||||||-3.06|-20.74|
71848780|NCT01263496|143211694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-11.97|7.08||||||||7.08|-11.97|
71848781|NCT01263496|143211694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.25|||||TWO_SIDED|95.0|-15.84|3.35||||||||3.35|-15.84|
71848782|NCT01263496|143211694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|||||TWO_SIDED|95.0|-15.28|1.41||||||||1.41|-15.28|
71848783|NCT01263496|143211694|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.73|||||TWO_SIDED|95.0|-22.67|-2.78||||||||-2.78|-22.67|
71848784|NCT01263496|143211695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.19|2.31||||||||2.31|-13.19|
71848785|NCT01263496|143211695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.77|||||TWO_SIDED|95.0|-13.53|5.99||||||||5.99|-13.53|
71848786|NCT01263496|143211695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-14.36|2.67||||||||2.67|-14.36|
71848787|NCT01263496|143211695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.22|||||TWO_SIDED|95.0|-20.72|-1.73||||||||-1.73|-20.72|
71848788|NCT01263496|143211696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|||||TWO_SIDED|95.0|-10.42|5.9||||||||5.90|-10.42|
71848789|NCT01263496|143211696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||||TWO_SIDED|95.0|-15.64|3.84||||||||3.84|-15.64|
71848790|NCT01263496|143211696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.47|||||TWO_SIDED|95.0|-16.52|-0.42||||||||-0.42|-16.52|
71848791|NCT01263496|143211696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.47|||||TWO_SIDED|95.0|-22.18|-2.76||||||||-2.76|-22.18|
71848792|NCT01263496|143211697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-7.1|7.77||||||||7.77|-7.10|
71848793|NCT01263496|143211697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|||||TWO_SIDED|95.0|-10.16|8.21||||||||8.21|-10.16|
71848794|NCT01263496|143211697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-9.71|5.95||||||||5.95|-9.71|
71848795|NCT01263496|143211697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.38|||||TWO_SIDED|95.0|-18.59|-0.18||||||||-0.18|-18.59|
71848796|NCT01263496|143211698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|||||TWO_SIDED|95.0|-10.2|6.75||||||||6.75|-10.20|
71848797|NCT01263496|143211698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.1|5.7||||||||5.70|-13.10|
71848798|NCT01263496|143211698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.97|||||TWO_SIDED|95.0|-12.94|5.0||||||||5.00|-12.94|
71848799|NCT01263496|143211698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.74|||||TWO_SIDED|95.0|-19.4|-0.08||||||||-0.08|-19.40|
71848800|NCT01263496|143211699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.43|||||TWO_SIDED|95.0|-11.0|6.15||||||||6.15|-11.00|
71848801|NCT01263496|143211699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|||||TWO_SIDED|95.0|-16.53|1.94||||||||1.94|-16.53|
71848802|NCT01263496|143211699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.3|||||TWO_SIDED|95.0|-17.93|-0.67||||||||-0.67|-17.93|
71848803|NCT01263496|143211699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.88|||||TWO_SIDED|95.0|-21.83|-1.93||||||||-1.93|-21.83|
71848804|NCT01263496|143211700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-9.68|7.27||||||||7.27|-9.68|
71816531|NCT01351025|143135355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.704|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in log10 D-dimer||||0.704
71816532|NCT01351025|143135356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.508|TWO_SIDED|||||Two-sided p-values of \< 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes (\[week 44 - week 24\] - \[week 20 - baseline\]) in CD8+ T-cell activation percent (% CD38+/DR+ of CD8+)||||0.508
71816533|NCT01373450|143135373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.87||||0.024|TWO_SIDED|90.0|0.77|0.98|||t-test, 1 sided|||||0.98|0.77|0.024
71848805|NCT01263496|143211700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.05|||||TWO_SIDED|95.0|-16.34|2.24||||||||2.24|-16.34|
71848806|NCT01263496|143211700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.86|||||TWO_SIDED|95.0|-17.47|-0.26||||||||-0.26|-17.47|
71848807|NCT01263496|143211700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.51|||||TWO_SIDED|95.0|-23.12|-3.89||||||||-3.89|-23.12|
71848808|NCT01263496|143211701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||||TWO_SIDED|95.0|-10.09|6.8||||||||6.80|-10.09|
71816534|NCT01373450|143135374|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.004|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.004
71816535|NCT01373450|143135375|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.014|||<|0.001|TWO_SIDED|90.0|0.008|0.019|||t-test, 1 sided|||||0.019|0.008|<0.001
71816536|NCT01373450|143135376|SUPERIORITY_OR_OTHER||Intraclass Correlation Coefficient|0.92|||||TWO_SIDED|90.0|0.72|0.98||||||||0.98|0.72|
71848809|NCT01263496|143211701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||||TWO_SIDED|95.0|-15.66|2.25||||||||2.25|-15.66|
71848810|NCT01263496|143211701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||||TWO_SIDED|95.0|-16.64|0.07||||||||0.07|-16.64|
71848811|NCT01263496|143211701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.82|||||TWO_SIDED|95.0|-27.39|-10.24||||||||-10.24|-27.39|
71848812|NCT01263496|143211702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.219|0.254||||||||0.254|-0.219|
71848813|NCT01263496|143211702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|0.002|0.451||||||||0.451|0.002|
71848814|NCT01263496|143211702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|0.008|0.453||||||||0.453|0.008|
71848815|NCT01263496|143211702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.282|||||TWO_SIDED|95.0|0.041|0.524||||||||0.524|0.041|
71848816|NCT01263496|143211703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|-0.173|0.353||||||||0.353|-0.173|
71816537|NCT01373450|143135377|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77||||0.003|TWO_SIDED|90.0|0.66|0.9|||t-test, 1 sided|||||0.90|0.66|0.003
71848817|NCT01263496|143211703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.228|||||TWO_SIDED|95.0|-0.01|0.467||||||||0.467|-0.010|
71848818|NCT01263496|143211703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|||||TWO_SIDED|95.0|0.095|0.584||||||||0.584|0.095|
71848819|NCT01263496|143211703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.468|||||TWO_SIDED|95.0|0.184|0.752||||||||0.752|0.184|
71816538|NCT01373450|143135377|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.58|||<|0.001|TWO_SIDED|90.0|0.45|0.74|||t-test, 1 sided|||||0.74|0.45|<0.001
71816539|NCT01373450|143135377|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99||||0.473|TWO_SIDED|90.0|0.85|1.16|||t-test, 1 sided|||||1.16|0.85|0.473
71816540|NCT01373450|143135377|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.75||||0.049|TWO_SIDED|90.0|0.56|1.0|||t-test, 1 sided|||||1.00|0.56|0.049
71816541|NCT01373450|143135378|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.021|||<|0.001|TWO_SIDED|90.0|0.015|0.026|||t-test, 1 sided|||||0.026|0.015|<0.001
71848820|NCT01263496|143211704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.317|||||TWO_SIDED|95.0|0.064|0.57||||||||0.570|0.064|
71848821|NCT01263496|143211704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.511|||||TWO_SIDED|95.0|0.236|0.786||||||||0.786|0.236|
71848822|NCT01263496|143211704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.437|||||TWO_SIDED|95.0|0.19|0.685||||||||0.685|0.190|
71848823|NCT01263496|143211704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.718|||||TWO_SIDED|95.0|0.413|1.022||||||||1.022|0.413|
71848824|NCT01263496|143211705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|||||TWO_SIDED|95.0|-0.029|0.481||||||||0.481|-0.029|
71816542|NCT01373450|143135378|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.03|||<|0.001|TWO_SIDED|90.0|0.021|0.038|||t-test, 1 sided|||||0.038|0.021|<0.001
71816543|NCT01373450|143135378|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.007||||0.0163|TWO_SIDED|90.0|0.002|0.012|||t-test, 1 sided|||||0.012|0.002|0.0163
71816544|NCT01373450|143135378|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.016||||0.0056|TWO_SIDED|90.0|0.006|0.026|||t-test, 1 sided|||||0.026|0.006|0.0056
71816545|NCT00510458|143135384|OTHER|It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).|mean linear wear rate at 5 yrs|0.008|||||TWO_SIDED|90.0|-0.0107|0.0267||||||||.0267|-0.0107|
71816546|NCT00510458|143135385|OTHER|To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71816547|NCT00510458|143135386|OTHER|To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71816548|NCT00510458|143135387|OTHER|To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71816549|NCT00510458|143135388|OTHER|To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71816550|NCT00510458|143135388|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.||||||0.0394|||||||t-test, 2 sided|||||||0.0394
71848825|NCT01263496|143211705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.358|||||TWO_SIDED|95.0|0.104|0.612||||||||0.612|0.104|
71816551|NCT00510458|143135388|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.||||||0.4974|||||||t-test, 2 sided|||||||0.4974
71816552|NCT00510458|143135388|OTHER|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.||||||0.677|||||||t-test, 2 sided|||||||0.6770
71816553|NCT00510458|143135389|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71816554|NCT00510458|143135389|OTHER|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.||||||0.0006|||||||t-test, 2 sided|||||||0.0006
71848826|NCT01263496|143211705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|0.076|0.54||||||||0.540|0.076|
71848827|NCT01263496|143211705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|0.098|0.565||||||||0.565|0.098|
71848828|NCT01263496|143211706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.13|0.41||||||||0.410|-0.130|
71848829|NCT01263496|143211706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|||||TWO_SIDED|95.0|-0.026|0.516||||||||0.516|-0.026|
71848830|NCT01263496|143211706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.294|||||TWO_SIDED|95.0|0.035|0.552||||||||0.552|0.035|
71848831|NCT01263496|143211706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|||||TWO_SIDED|95.0|0.032|0.626||||||||0.626|0.032|
71848832|NCT01263496|143211707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|||||TWO_SIDED|95.0|-0.252|0.349||||||||0.349|-0.252|
71848833|NCT01263496|143211707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|0.138|0.703||||||||0.703|0.138|
71899512|NCT00570739|143321574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.4794|TWO_SIDED|95.0|0.31|1.4||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||1.40|0.31|0.4794
71899513|NCT00570739|143321574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.6667|TWO_SIDED|95.0|0.37|1.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF||1.55|0.37|0.6667
71899514|NCT00570739|143321574|SUPERIORITY_OR_OTHER|||||||0.2768||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.2768
71899515|NCT00570739|143321574|SUPERIORITY_OR_OTHER|||||||0.4395||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.4395
71899516|NCT00570739|143321575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43||||0.1375|TWO_SIDED|95.0|0.89|6.64||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks||6.64|0.89|0.1375
71899517|NCT00570739|143321575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.1996|TWO_SIDED|95.0|0.85|5.82|||Cochran-Mantel-Haenszel|P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.||Baseline to 16 Weeks LOCF||5.82|0.85|0.1996
71899518|NCT00570739|143321575|SUPERIORITY_OR_OTHER|||||||0.0829||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks||||0.0829
71899519|NCT00570739|143321575|SUPERIORITY_OR_OTHER|||||||0.1037||95.0|||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF||||0.1037
71899520|NCT00803244|143321613|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.49||||0.2344||95.0|-1.3|0.32|||ANCOVA|||||0.32|-1.30|0.2344
71899521|NCT00803244|143321614|SUPERIORITY_OR_OTHER||LS Mean difference vs. Placebo|-0.09||||0.0401|TWO_SIDED|95.0|-0.18|0.0|||ANCOVA||Relative LS Means difference (%) = -19.7|||0.00|-0.18|0.0401
71899522|NCT02144220|143321634|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
71899523|NCT00053846|143321658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.483|STANDARD_ERROR_OF_MEAN|0.275||0.08|TWO_SIDED|95.0|-1.02|0.0576|||ANCOVA||Multiple Imputation (MI) used for estimates. MICE software in R was used to generate 100 imputed datasets. ANCOVA was run on each, and results were pooled.|H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.||0.0576|-1.020|0.080
71679201|NCT02122770|142876542|SUPERIORITY||Geometric LS Mean Ratio|110.21|||||TWO_SIDED|90.0|102.34|118.69||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||118.69|102.34|
71679202|NCT02122770|142876543|SUPERIORITY||Geometric LS Mean Ratio|110.66|||||TWO_SIDED|90.0|102.53|119.43||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||119.43|102.53|
71679203|NCT02122770|142876544|SUPERIORITY||Geometric LS Mean Ratio|113.05|||||TWO_SIDED|90.0|85.35|149.74||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||149.74|85.35|
71816555|NCT03573908|143135400|SUPERIORITY||Least squares (LS) mean difference|-0.715|||<|0.0001|TWO_SIDED|95.0|-0.998|-0.433|||MMRM||Least squares (LS) mean difference (linaclotide - placebo)|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.433|-0.998|< 0.0001
71816556|NCT03573908|143135401|SUPERIORITY||Hodges-Lehman Estimated Median Threshold|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.88|-0.35|||Wilcoxon Rank Sum Test|P-value comparing change from baseline distributions by treatment using the Wilcoxon rank sum test 2-sided.|95% confidence interval (CI) for Hodges-Lehmann estimated median threshold was generated by Moses confidence limits method.|The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.35|-0.88|< 0.0001
71816557|NCT03573908|143135402|SUPERIORITY||Difference in Responder Rate|17.1|||||TWO_SIDED|95.0|9.9|24.4|||||95% confidence intervals for difference in responder rate are obtained using the normal approximation to the binomial distribution.|||24.4|9.9|
71816558|NCT03573908|143135402|SUPERIORITY||Odds Ratio (OR)|2.2|||<|0.0001|TWO_SIDED|95.0|1.55|3.12||Odds ratio, 95% CI for the Odds Ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for geographic region.|Cochran-Mantel-Haenszel|||The overall family-wise Type I error rate for the primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||3.12|1.55|< 0.0001
71816559|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.867|||<|0.0001|TWO_SIDED|95.0|-1.219|-0.515||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 12. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.515|-1.219|< 0.0001
71816560|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.719|||<|0.0001|TWO_SIDED|95.0|-1.062|-0.376||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 10. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.376|-1.062|< 0.0001
71848834|NCT01263496|143211707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.46|||||TWO_SIDED|95.0|0.178|0.742||||||||0.742|0.178|
71848835|NCT01263496|143211707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.384|||||TWO_SIDED|95.0|0.085|0.683||||||||0.683|0.085|
71848836|NCT01263496|143211708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.257|0.326||||||||0.326|-0.257|
71848837|NCT01263496|143211708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|||||TWO_SIDED|95.0|-0.043|0.542||||||||0.542|-0.043|
71848838|NCT01263496|143211708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|||||TWO_SIDED|95.0|-0.196|0.417||||||||0.417|-0.196|
71848839|NCT01263496|143211708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|||||TWO_SIDED|95.0|0.01|0.656||||||||0.656|0.010|
71848840|NCT01263496|143211709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.268|||||TWO_SIDED|95.0|-0.769|0.233||||||||0.233|-0.769|
71848841|NCT01263496|143211709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.349|||||TWO_SIDED|95.0|-0.156|0.855||||||||0.855|-0.156|
71848842|NCT01263496|143211709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.297|0.577||||||||0.577|-0.297|
71848843|NCT01263496|143211709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.308|||||TWO_SIDED|95.0|-0.075|0.69||||||||0.690|-0.075|
71899524|NCT03008590|143321659|SUPERIORITY|||||||0.9||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.90
71679204|NCT02122770|142876544|SUPERIORITY||Geometric LS Mean Ratio|159.55|||||TWO_SIDED|90.0|89.97|282.96||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||282.96|89.97|
71679205|NCT02122770|142876544|SUPERIORITY||Geometric LS Mean Ratio|77.26|||||TWO_SIDED|90.0|55.19|108.17||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||108.17|55.19|
71848844|NCT01263496|143211710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|-0.367|0.928||||||||0.928|-0.367|
71848845|NCT01263496|143211710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.579|||||TWO_SIDED|95.0|-0.035|1.194||||||||1.194|-0.035|
71848846|NCT01263496|143211710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.647|||||TWO_SIDED|95.0|0.054|1.241||||||||1.241|0.054|
71848847|NCT01263496|143211710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|||||TWO_SIDED|95.0|-0.28|0.785||||||||0.785|-0.280|
71848848|NCT01263496|143211711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.246|0.646||||||||0.646|-1.246|
71848849|NCT01263496|143211711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.643|||||TWO_SIDED|95.0|-0.305|1.591||||||||1.591|-0.305|
71848850|NCT01263496|143211711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.599|0.888||||||||0.888|-0.599|
71848851|NCT01263496|143211711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||||TWO_SIDED|95.0|-0.673|1.173||||||||1.173|-0.673|
71848852|NCT01263496|143211712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||||TWO_SIDED|95.0|-4.462|2.562||||||||2.562|-4.462|
71848853|NCT01263496|143211712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|||||TWO_SIDED|95.0|-2.712|2.779||||||||2.779|-2.712|
71899525|NCT03008590|143321660|SUPERIORITY|||||||0.22||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.22
71848854|NCT01263496|143211712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.273|2.073||||||||2.073|-3.273|
71848855|NCT01263496|143211712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.874|2.074||||||||2.074|-2.874|
71848856|NCT01263496|143211713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||||TWO_SIDED|95.0|-0.14|0.458||||||||0.458|-0.140|
71848857|NCT01263496|143211713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-0.001|0.52||||||||0.520|-0.001|
71848858|NCT01263496|143211713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|||||TWO_SIDED|95.0|-0.126|0.398||||||||0.398|-0.126|
71848859|NCT01263496|143211713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.298|||||TWO_SIDED|95.0|0.042|0.553||||||||0.553|0.042|
71848860|NCT01263496|143211714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92|||||TWO_SIDED|95.0|-11.82|7.99||||||||7.99|-11.82|
71848861|NCT01263496|143211714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||||TWO_SIDED|95.0|-12.45|6.4||||||||6.40|-12.45|
71848862|NCT01263496|143211714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||||TWO_SIDED|95.0|-18.77|1.96||||||||1.96|-18.77|
71848863|NCT01263496|143211714|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||||TWO_SIDED|95.0|-18.35|0.44||||||||0.44|-18.35|
71848864|NCT01263496|143211715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.66|||||TWO_SIDED|95.0|-3.88|19.19||||||||19.19|-3.88|
71848865|NCT01263496|143211715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-11.41|9.24||||||||9.24|-11.41|
71848866|NCT01263496|143211715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-12.91|10.75||||||||10.75|-12.91|
71848867|NCT01263496|143211715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-11.32|9.99||||||||9.99|-11.32|
71848868|NCT01263496|143211716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-7.09|16.49||||||||16.49|-7.09|
71848869|NCT01263496|143211716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|||||TWO_SIDED|95.0|-8.63|11.89||||||||11.89|-8.63|
71848870|NCT01263496|143211716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|||||TWO_SIDED|95.0|-13.36|7.98||||||||7.98|-13.36|
71848871|NCT01263496|143211716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.58|2.17||||||||2.17|-20.58|
71848872|NCT01263496|143211717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-11.44|9.84||||||||9.84|-11.44|
71848873|NCT01263496|143211717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|||||TWO_SIDED|95.0|-11.74|7.66||||||||7.66|-11.74|
71848874|NCT01263496|143211717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-15.62|4.75||||||||4.75|-15.62|
71848875|NCT01263496|143211717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.28|||||TWO_SIDED|95.0|-23.83|-2.74||||||||-2.74|-23.83|
71848876|NCT01263496|143211718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||||TWO_SIDED|95.0|-28.15|14.1||||||||14.10|-28.15|
71848877|NCT01263496|143211718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.45|||||TWO_SIDED|95.0|-23.93|13.02||||||||13.02|-23.93|
71848878|NCT01263496|143211718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|||||TWO_SIDED|95.0|-35.46|-0.13||||||||-0.13|-35.46|
71848879|NCT01263496|143211718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.58|||||TWO_SIDED|95.0|-47.75|-13.41||||||||-13.41|-47.75|
71848880|NCT01263496|143211719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|||||TWO_SIDED|95.0|-5.18|42.09||||||||42.09|-5.18|
71848881|NCT01263496|143211719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.86|||||TWO_SIDED|95.0|-13.56|33.28||||||||33.28|-13.56|
71848882|NCT01263496|143211719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.44|||||TWO_SIDED|95.0|-30.25|15.37||||||||15.37|-30.25|
71848883|NCT01263496|143211719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-34.75|9.15||||||||9.15|-34.75|
71848884|NCT01263496|143211720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.84|||||TWO_SIDED|95.0|-13.9|25.58||||||||25.58|-13.90|
71679206|NCT02122770|142876545|SUPERIORITY||Geometric LS Mean Ratio|121.57|||||TWO_SIDED|90.0|110.92|133.24||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||133.24|110.92|
71679207|NCT02122770|142876545|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
71816561|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.665||||0.0002|TWO_SIDED|95.0|-1.007|-0.322||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 8. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.322|-1.007|0.0002
71816562|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.831|||<|0.0001|TWO_SIDED|95.0|-1.151|-0.511||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 6. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.511|-1.151|< 0.0001
71816563|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.982|-0.383||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 4. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.383|-0.982|< 0.0001
71816564|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.628|||<|0.0001|TWO_SIDED|95.0|-0.888|-0.368||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 2. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.368|-0.888|< 0.0001
71816565|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.435|||<|0.0001|TWO_SIDED|95.0|-0.641|-0.228||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 1. The overall family-wise Type I error rate for primary and secondary outcome measures were controlled at the α=0.05 level by employing a fixed-sequence testing procedure. Outcome measures were tested using 10 hypotheses, each comparing linaclotide versus placebo, in the sequence of presentation of statistical analyses in this record. If the hypothesis comparing the 2 groups was statistically significant (α=0.05), then the next hypothesis was to be tested; otherwise, testing would stop.||-0.228|-0.641|< 0.0001
71816566|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.683|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.398||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 3. Not part of the fixed-sequence testing procedure.||-0.398|-0.969|< 0.0001
71816567|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.768|||<|0.0001|TWO_SIDED|95.0|-1.076|-0.46||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 5. Not part of the fixed-sequence testing procedure.||-0.460|-1.076|< 0.0001
71816568|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.758|||<|0.0001|TWO_SIDED|95.0|-1.086|-0.431||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 7. Not part of the fixed-sequence testing procedure.||-0.431|-1.086|< 0.0001
71816569|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.043|-0.363||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 9. Not part of the fixed-sequence testing procedure.||-0.363|-1.043|< 0.0001
71816570|NCT03573908|143135403|SUPERIORITY||LS mean difference|-0.844|||<|0.0001|TWO_SIDED|95.0|-1.189|-0.498||LS mean difference and p-value were obtained based on an MMRM with treatment, analysis week, geographic region, and treatment-by-week interactions as fixed effects, and baseline score as a covariate.|MMRM|||Week 11. Not part of the fixed-sequence testing procedure.||-0.498|-1.189|< 0.0001
71816571|NCT04006925|143135404|OTHER||Median Difference (Net)|-23.5||||0.03|TWO_SIDED|95.0|-41.0|-2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||-2.0|-41.0|0.03
71816572|NCT04006925|143135404|OTHER||Median Difference (Net)|-9.0||||0.11|TWO_SIDED|95.0|-21.5|0.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-21.5|0.11
71848885|NCT01263496|143211720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.35|||||TWO_SIDED|95.0|-18.2|24.9||||||||24.90|-18.20|
71816573|NCT04006925|143135404|SUPERIORITY||Median Difference (Net)|-14.5||||0.27|TWO_SIDED|95.0|-32.0|11.3||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||11.3|-32.0|0.27
71816574|NCT04006925|143135405|OTHER||Median Difference (Net)|-1.0||||0.02|TWO_SIDED|95.0|-3.0|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||0.0|-3.0|0.02
71816575|NCT04006925|143135405|OTHER||Median Difference (Net)|0.0||||0.83|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||1.0|-1.0|0.83
71816576|NCT04006925|143135405|SUPERIORITY||Median Difference (Net)|-1.0||||0.09|TWO_SIDED|95.0|-3.5|0.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||0.0|-3.5|0.09
71816577|NCT04006925|143135406|SUPERIORITY|||||||0.08||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.08
71816578|NCT04006925|143135407|SUPERIORITY|||||||0.18||||||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||||0.18
71816579|NCT04006925|143135408|OTHER||Median Difference (Net)|-1.0||||0.26|TWO_SIDED|95.0|-7.0|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-7.0|0.26
71816580|NCT04006925|143135408|OTHER||Median Difference (Final Values)|-0.5||||0.43|TWO_SIDED|95.0|-3.5|2.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Wilcoxon Signed Rank test|||Within group analysis of change from baseline.||2.0|-3.5|0.43
71679208|NCT02122770|142876545|SUPERIORITY||Geometric LS Mean Ratio|101.36|||||TWO_SIDED|90.0|90.72|113.23||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||113.23|90.72|
71848886|NCT01263496|143211720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-26.03|18.74||||||||18.74|-26.03|
71816581|NCT04006925|143135408|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.65|TWO_SIDED|95.0|-4.0|3.0||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Mann Whitney U test|||Between group analysis of change from baseline.||3.0|-4.0|0.65
71816582|NCT04006925|143135409|OTHER||Mean Difference (Net)|-6.2||||0.23|TWO_SIDED|95.0|-15.2|1.7||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||1.7|-15.2|0.23
71816583|NCT04006925|143135409|OTHER||Mean Difference (Net)|0.2||||0.95|TWO_SIDED|95.0|-4.6|4.5||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Unpaired T-test|||Within group analysis of change from baseline.||4.5|-4.6|0.95
71816584|NCT04006925|143135409|SUPERIORITY||Mean Difference (Net)|-6.4||||0.22|TWO_SIDED|95.0|-16.2|3.1||All statistical tests were conducted using a 2-sided alpha level of 0.05.|Paired T-test|||Between group analysis of change from baseline.||3.1|-16.2|0.22
71816585|NCT01755143|143135411|SUPERIORITY_OR_OTHER||Percentage|100.0|||<|0.0001|ONE_SIDED|97.5|97.7|||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI \<90%.|||97.7|<0.0001
71816586|NCT01755143|143135412|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.0|||||TWO_SIDED|||||A priori threshold for statistical significance was 0.025. Because there were no failures in either group, a p-value could not be calculated.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||||
71816587|NCT01755143|143135413|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|-0.7|||<|0.0001|TWO_SIDED|95.0|-5.4|4.1||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.||4.1|-5.4|<0.0001
71816588|NCT01755143|143135414|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|1.6|||<|0.0001|ONE_SIDED|95.0|-3.2|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-3.2|<0.0001
71816589|NCT01755143|143135415|SUPERIORITY_OR_OTHER||Percentage|0.0|||<|0.0001|ONE_SIDED|95.0||1.9|||exact test of binomial proportions|A priori threshold for statistical significance was 0.05.||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans \>= 10%.||1.9||<0.0001
71816590|NCT01755143|143135416|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 10%.|Risk Difference (RD)|0.2||||0.0004|ONE_SIDED|95.0|-4.8||||Farrington-Manning test|A priori threshold for statistical significance was 0.05.||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|||-4.8|0.0004
71816591|NCT04466215|143135417|SUPERIORITY||Slope|-0.063|STANDARD_ERROR_OF_MEAN|0.04||0.065|TWO_SIDED|||||One-tail test of directional hypothesis.|Mixed Models Analysis|||Mixed effect model with directional hypothesis that drug reduces strength of craving (VAS). Principle predictor was drug plasma concentration. Arms were combined for this analysis.||||.065
71848887|NCT01263496|143211720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.37|||||TWO_SIDED|95.0|-47.08|0.34||||||||0.34|-47.08|
71848888|NCT01263496|143211721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-18.77|24.71||||||||24.71|-18.77|
71848889|NCT01263496|143211721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-21.21|23.94||||||||23.94|-21.21|
71848890|NCT01263496|143211721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||||TWO_SIDED|95.0|-32.69|10.3||||||||10.30|-32.69|
71848891|NCT01263496|143211721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.9|||||TWO_SIDED|95.0|-56.85|-12.96||||||||-12.96|-56.85|
71848892|NCT01263496|143211722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.955|||||TWO_SIDED|95.0|0.375|1.535||||||||1.535|0.375|
71848893|NCT01263496|143211722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.752|1.965||||||||1.965|0.752|
71848894|NCT01263496|143211722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.35|||||TWO_SIDED|95.0|0.724|1.975||||||||1.975|0.724|
71848895|NCT01263496|143211722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.38|||||TWO_SIDED|95.0|0.804|1.955||||||||1.955|0.804|
71848896|NCT01263496|143211723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.034|||||TWO_SIDED|95.0|0.344|1.723||||||||1.723|0.344|
71848897|NCT01263496|143211723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.448|||||TWO_SIDED|95.0|0.78|2.115||||||||2.115|0.780|
71848898|NCT01263496|143211723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.243|||||TWO_SIDED|95.0|0.616|1.87||||||||1.870|0.616|
71848899|NCT01263496|143211723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.481|||||TWO_SIDED|95.0|0.827|2.136||||||||2.136|0.827|
71848900|NCT01263496|143211724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|-4.088|4.188||||||||4.188|-4.088|
71848901|NCT01263496|143211724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.585|||||TWO_SIDED|95.0|-3.476|6.647||||||||6.647|-3.476|
71848902|NCT01263496|143211724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.517|||||TWO_SIDED|95.0|-8.151|9.184||||||||9.184|-8.151|
71899526|NCT03008590|143321661|SUPERIORITY|||||||0.02||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.02
71899527|NCT03008590|143321662|SUPERIORITY|||||||0.3||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.3
71899528|NCT03008590|143321663|SUPERIORITY|||||||0.04||||||Although significance was pre-specified at P\<0.05, it is suspected that this result is spurious due to multiple comparisons|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.04
71899529|NCT03008590|143321664|SUPERIORITY|||||||0.78||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.78
71679209|NCT02122770|142876546|SUPERIORITY||Geometric LS Mean Ratio|122.95|||||TWO_SIDED|90.0|112.13|134.82||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||134.82|112.13|
71848903|NCT01263496|143211724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.277|||||TWO_SIDED|95.0|-2.191|4.744||||||||4.744|-2.191|
71848904|NCT01263496|143211725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.841|||||TWO_SIDED|95.0|0.239|1.443||||||||1.443|0.239|
71848905|NCT01263496|143211725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.304|||||TWO_SIDED|95.0|0.679|1.93||||||||1.930|0.679|
71848906|NCT01263496|143211725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.992|||||TWO_SIDED|95.0|0.4|1.585||||||||1.585|0.400|
71848907|NCT01263496|143211725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.263|||||TWO_SIDED|95.0|0.674|1.853||||||||1.853|0.674|
71848908|NCT01263496|143211726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.891|||||TWO_SIDED|95.0|9.597|22.184||||||||22.184|9.597|
71848909|NCT01263496|143211726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.026|||||TWO_SIDED|95.0|12.466|23.585||||||||23.585|12.466|
71848910|NCT01263496|143211726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.838|||||TWO_SIDED|95.0|14.379|25.297||||||||25.297|14.379|
71848911|NCT01263496|143211726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.368|||||TWO_SIDED|95.0|8.677|22.06||||||||22.060|8.677|
71848912|NCT01263496|143211727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.323|||||TWO_SIDED|95.0|6.567|22.079||||||||22.079|6.567|
71848913|NCT01263496|143211727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.714|||||TWO_SIDED|95.0|14.563|26.864||||||||26.864|14.563|
71848914|NCT01263496|143211727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.063|||||TWO_SIDED|95.0|13.125|25.002||||||||25.002|13.125|
71848915|NCT01263496|143211727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.233|||||TWO_SIDED|95.0|6.618|23.847||||||||23.847|6.618|
71848916|NCT01263496|143211728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.047|||||TWO_SIDED|95.0|1.169|14.924||||||||14.924|1.169|
71848917|NCT01263496|143211728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.95|||||TWO_SIDED|95.0|7.767|20.133||||||||20.133|7.767|
71848918|NCT01263496|143211728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.221|||||TWO_SIDED|95.0|9.191|21.251||||||||21.251|9.191|
71848919|NCT01263496|143211728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.366|||||TWO_SIDED|95.0|5.847|20.885||||||||20.885|5.847|
71848920|NCT01263496|143211729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.719|||||TWO_SIDED|95.0|1.657|13.782||||||||13.782|1.657|
71848921|NCT01263496|143211729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.978|||||TWO_SIDED|95.0|7.556|18.399||||||||18.399|7.556|
71848922|NCT01263496|143211729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.076|||||TWO_SIDED|95.0|9.808|20.345||||||||20.345|9.808|
71848923|NCT01263496|143211729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.087|||||TWO_SIDED|95.0|6.561|19.614||||||||19.614|6.561|
71848924|NCT01263496|143211730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.76|||||TWO_SIDED|95.0|-7.03|20.55||||||||20.55|-7.03|
71848925|NCT01263496|143211730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.85|||||TWO_SIDED|95.0|-1.49|25.19||||||||25.19|-1.49|
71848926|NCT01263496|143211730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.72|||||TWO_SIDED|95.0|-5.12|24.56||||||||24.56|-5.12|
71848927|NCT01263496|143211730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|95.0|-13.26|14.9||||||||14.90|-13.26|
71899530|NCT03008590|143321665|SUPERIORITY|||||||0.92||||||Significance pre-specified at P\<0.05|Mixed Models Analysis|||Data from the primary or secondary outcome measures were the dependent variables. The patient was the random effect. Dependent fixed effects variables included treatment at the time of data collection (naltrexone or placebo), group (naltrexone first or placebo first), and week (4, 8, 12, and 16).||||0.92
71679210|NCT02122770|142876546|SUPERIORITY||Geometric LS Mean Ratio|130.16|||||TWO_SIDED|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference||158.35|106.99|
71848928|NCT01263496|143211731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-11.11|22.91||||||||22.91|-11.11|
71848929|NCT01263496|143211731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57|||||TWO_SIDED|95.0|-7.21|28.35||||||||28.35|-7.21|
71848930|NCT01263496|143211731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.45|||||TWO_SIDED|95.0|-10.08|26.98||||||||26.98|-10.08|
71848931|NCT01263496|143211731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.82|||||TWO_SIDED|95.0|-10.67|24.3||||||||24.30|-10.67|
71899531|NCT00872833|143321672|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
71899532|NCT00872833|143321673|SUPERIORITY_OR_OTHER|||||||0.028|||||||Chi-squared|||||||0.028
71899533|NCT01417780|143321694|OTHER|||||||0.016|||||||ANOVA|||||||0.016
71899534|NCT01417780|143321695|OTHER|||||||0.019|||||||Chi-squared|||The null hypothesis was that the frequency of Day 14 SOFA score less than or equal to 1 was not different among treatment groups.||||0.019
71899535|NCT01417780|143321696|OTHER|||||||0.11||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.11
71816592|NCT01555164|143135422|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.11||||0.306|TWO_SIDED|95.0|-0.31|0.1||P-value from a mixed-effect model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.4% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||0.10|-0.31|0.306
71816593|NCT00926003|143135425|SUPERIORITY|||||||0.02|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.02
71679211|NCT02122770|142876546|SUPERIORITY||Geometric LS Mean Ratio|100.89|||||TWO_SIDED|90.0|91.14|111.68||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.||111.68|91.14|
71816594|NCT00926003|143135426|SUPERIORITY|||||||0.18|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline||||0.18
71816595|NCT01709305|143135444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.19|||||TWO_SIDED|98.34|0.02|0.36||||||Pairwise Comparison||0.36|0.02|
71816596|NCT01709305|143135444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.03|||||TWO_SIDED|98.34|-0.15|0.21||||||Pairwise Comparison||0.21|-0.15|
71816597|NCT01709305|143135444|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|-0.05|||||TWO_SIDED|98.34|-0.23|0.14||||||Pairwise Comparison||0.14|-0.23|
71816598|NCT01709305|143135446|SUPERIORITY_OR_OTHER||Estimate|-8.4|||<|0.001|TWO_SIDED|95.0|-11.1|-6.1|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-6.1|-11.1|<0.001
71816599|NCT01709305|143135446|SUPERIORITY_OR_OTHER||Estimate|-2.9||||0.072|TWO_SIDED|95.0|-6.1|0.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.3|-6.1|0.072
71848932|NCT01263496|143211732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||||TWO_SIDED|95.0|-14.95|21.13||||||||21.13|-14.95|
71848933|NCT01263496|143211732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-15.61|20.57||||||||20.57|-15.61|
71848934|NCT01263496|143211732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-21.0|19.68||||||||19.68|-21.00|
71848935|NCT01263496|143211732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|||||TWO_SIDED|95.0|-17.47|20.05||||||||20.05|-17.47|
71848936|NCT01263496|143211733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||||TWO_SIDED|95.0|-11.7|19.86||||||||19.86|-11.70|
71848937|NCT01263496|143211733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94|||||TWO_SIDED|95.0|-11.14|21.03||||||||21.03|-11.14|
71848938|NCT01263496|143211733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65|||||TWO_SIDED|95.0|-14.42|21.73||||||||21.73|-14.42|
71848939|NCT01263496|143211733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||||TWO_SIDED|95.0|-17.24|15.89||||||||15.89|-17.24|
71848940|NCT00046475|143211734|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
71899536|NCT01417780|143321697|OTHER|||||||0.18||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.18
71899537|NCT01417780|143321698|OTHER|||||||0.19||||||Wilcoxon p value represents comparison of active dose groups versus placebo group.|Wilcoxon (Mann-Whitney)|||||||0.19
71899538|NCT01345786|143321699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|137.5||||||90.0|131.0|144.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||144.4|131|
71899539|NCT01345786|143321699|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|111.8||||||90.0|107.5|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|107.5|
71899540|NCT01345786|143321700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|107.3||||||90.0|99.0|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||116.4|99|
71899541|NCT01345786|143321700|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.6||||||90.0|99.2|108.2|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||108.2|99.2|
71679212|NCT00535847|142876582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.703|||||TWO_SIDED|95.0|4.259|37.884||||||Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.||37.884|4.259|
71679213|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-7.3|-0.1||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-7.3|
71679214|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-10.9|-0.1||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.1|-10.9|
71679215|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-7.9||||||95.0|-12.4|-4.0||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-4.0|-12.4|
71679216|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.7|3.5||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.5|-2.7|
71679217|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.6||||||95.0|-4.7|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-4.7|
71679218|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.4|3.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.4|-2.4|
71679219|NCT00373958|142876597|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-3.6||||||95.0|-8.5|1.2||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-8.5|
71679220|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.8||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||0.80|0.57|
71679221|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.74||||||95.0|0.61|0.89||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.61|
71679222|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.62|0.85||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||0.85|0.62|
71816600|NCT01709305|143135446|SUPERIORITY_OR_OTHER||Estimate|-5.3|||<|0.001|TWO_SIDED|95.0|-8.3|-2.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||-2.5|-8.3|<0.001
71816601|NCT01709305|143135447|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
71816602|NCT01709305|143135447|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
71816603|NCT01709305|143135447|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
71816604|NCT01709305|143135448|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.998|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.998
71816605|NCT01709305|143135448|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.319|TWO_SIDED|95.0|-1.0|0.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.5|-1.0|0.319
71816606|NCT01709305|143135448|SUPERIORITY_OR_OTHER||Estimate|0.0||||0.999|TWO_SIDED|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.9|-0.9|0.999
71816607|NCT01709305|143135449|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.651
71816608|NCT01709305|143135449|SUPERIORITY_OR_OTHER||Estimate|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.8|-1.3|0.660
71816609|NCT01709305|143135449|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.48|TWO_SIDED|95.0|-0.8|1.6|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.6|-0.8|0.480
71816610|NCT01709305|143135450|SUPERIORITY_OR_OTHER||Estimate|0.4||||0.158|TWO_SIDED|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.3|-0.3|0.158
71816611|NCT01709305|143135450|SUPERIORITY_OR_OTHER||Estimate|0.0|||>|0.999|TWO_SIDED|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||0.7|-0.7|>0.999
71816612|NCT01709305|143135450|SUPERIORITY_OR_OTHER||Estimate|0.2||||0.318|TWO_SIDED|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride||1.0|-0.5|0.318
71816613|NCT02708433|143135485|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|49.0||0.74|TWO_SIDED|95.0|-0.49|0.57|||Wilcoxon (Mann-Whitney)|||||0.57|-0.49|0.74
71816614|NCT02708433|143135486|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|48.0||0.5|TWO_SIDED|95.0|-0.89|0.52|||Wilcoxon (Mann-Whitney)|||||0.52|-0.89|0.5
71816615|NCT00552786|143135601|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two-sided|ANOVA|Assessing the bioequivalence on temporary threshold shift at3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
71816616|NCT00552786|143135602|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|Assessing the bioequivalence on temporary threshold shift at 3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.||||||<0.05
71816617|NCT02254408|143135667|SUPERIORITY||Treatment Difference|-0.33||||0.04|TWO_SIDED|95.0|-0.64|-0.02|||ANCOVA|||||-0.02|-0.64|0.040
71816618|NCT02254408|143135668|SUPERIORITY||Odds Ratio (OR)|0.5||||0.11|TWO_SIDED|95.0|0.22|1.18|||Cochran-Mantel-Haenszel|||||1.18|0.22|0.11
71816619|NCT02254408|143135668|SUPERIORITY|||||||0.15|||||||Fisher Exact|||||||0.15
71816620|NCT02254408|143135669|SUPERIORITY||Odds Ratio (OR)|1.01||||0.98|TWO_SIDED|95.0|0.28|3.63|||Cochran-Mantel-Haenszel|||||3.63|0.28|0.98
71816621|NCT02254408|143135669|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71899542|NCT01345786|143321701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|110.0||||||90.0|106.4|113.7|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUClast||113.7|106.4|
71899543|NCT01345786|143321701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.3||||||90.0|100.9|105.7|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC last||105.7|100.9|
71816622|NCT02914184|143135670|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|1.07|||||TWO_SIDED|95.0|0.79|1.44|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.44|0.79|
71816623|NCT02914184|143135670|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.88|||||TWO_SIDED|95.0|0.65|1.19|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_A and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.19|0.65|
71816624|NCT02914184|143135670|OTHER|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the \[0.5; 2\] clinical limit interval.|GMC Ratio at At Month 2-4|0.82|||||TWO_SIDED|95.0|0.61|1.11|||ANOVA|||GMC Ratio of Anti-RV IgA antibody for Liq\_B and Liq\_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.||1.11|0.61|
71816625|NCT02914184|143135671|NON_INFERIORITY|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in SCR for antibodies to rota virus at month 2-4 between the Liq\_Pool group and Lyo Control group should be ≥ -10%.|SCR difference at Month 2-4|-2.49|||||TWO_SIDED|95.0|-7.15|2.63||||||Non-inferiority of Liq\_Pool group compared to Lyo Control group in terms of difference in % of subjects with anti-RV IgA titer ≥ specified cut off with its 2-sided 95% CI in initially seronegative subjects||2.63|-7.15|
71816626|NCT02914184|143135673|NON_INFERIORITY|LL of the two-sided 95% CI for the ratio of anti-RV IgA antibody GMCs between the Liq\_Pool Group and Control group should be ≥ 0.67.|GMC Ratio at At Month 2-4|1.04|||||TWO_SIDED|95.0|0.82|1.33|||ANOVA|||Non-inferiority of Liq\_Pool Group as compared to Lyo Control group in terms of the GMC ratio calculated using ANOVA model with vaccine groups and country as fixed effects||1.33|0.82|
71816627|NCT00798174|143135680|SUPERIORITY|The null hypothesis was that the azygos coil does not reduce the DFT. (A reduced DFT is superiority).||||||0.103||||||Threshold for significance is 0.05.|t-test, 2 sided|Paired t-test||"The null hypothesis is that there is no difference between the DFT using the azygos coil vs. the standard configuration.~Paired t-test (two-tailed), used due to construction of study with DFT determined in both configurations in each patient, yields p=0.103"||||0.103
71816628|NCT03980184|143135695|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
71816629|NCT03980184|143135696|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<.001
71816630|NCT03980184|143135697|SUPERIORITY|||||||0.703|||||||Fisher Exact|||||||0.703
71816631|NCT03980184|143135699|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71816632|NCT03980184|143135700|SUPERIORITY|||||||0.647|||||||Fisher Exact|||||||0.647
71816633|NCT03980184|143135701|SUPERIORITY|||||||0.887|||||||Fisher Exact|||||||0.887
71816634|NCT01118455|143135707|SUPERIORITY_OR_OTHER|||||||0.507|||||||Cochran-Mantel-Haenszel|||||||0.507
71816635|NCT01118455|143135707|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Cochran-Mantel-Haenszel|||||||0.220
71816636|NCT01118455|143135707|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Cochran-Mantel-Haenszel|||||||0.168
71816637|NCT01118455|143135707|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Cochran-Mantel-Haenszel|||||||0.620
71816638|NCT01118455|143135708|SUPERIORITY_OR_OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||||||0.727
71816639|NCT01118455|143135708|SUPERIORITY_OR_OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
71816640|NCT01118455|143135708|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
71899544|NCT01345786|143321701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|108.1||||||90.0|104.7|111.6|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUC infinity||111.6|104.7|
71816641|NCT01118455|143135708|SUPERIORITY_OR_OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
71816642|NCT01118455|143135709|SUPERIORITY_OR_OTHER|||||||0.448||95.0|||||t-test, 2 sided|||||||0.448
71816643|NCT01118455|143135709|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||t-test, 2 sided|||||||0.025
71816644|NCT01118455|143135709|SUPERIORITY_OR_OTHER|||||||0.799|||||||t-test, 2 sided|||||||0.799
71816645|NCT01118455|143135709|SUPERIORITY_OR_OTHER|||||||0.142|||||||t-test, 2 sided|||||||0.142
71816646|NCT01118455|143135710|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||t-test, 2 sided|||||||0.714
71816647|NCT01118455|143135710|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
71816648|NCT01118455|143135710|SUPERIORITY_OR_OTHER|||||||0.467|||||||t-test, 2 sided|||||||0.467
71899545|NCT01345786|143321701|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.1||||||90.0|100.5|105.8|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC infinity||105.8|100.5|
71899546|NCT01345786|143321702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.5||||||90.0|96.7|106.4|||||Commercial Batch Test / Phase 3 Batch Reference.|||106.4|96.7|
71899547|NCT01345786|143321702|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.3||||||90.0|98.1|104.7|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."|||104.7|98.1|
71899548|NCT01929044|143321709|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to the non-inferiority margin of 1|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|Restricted maximum likelihood (REML) -repeated measures approach||0.04|-0.88|<0.0001
71679223|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
71816649|NCT01118455|143135710|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|||||||0.654
71899549|NCT01929044|143321709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.23||0.0743|TWO_SIDED|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.04|-0.88|0.0743
71899550|NCT01929044|143321710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.2||0.121|TWO_SIDED|95.0|-0.7|0.08|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.08|-0.70|0.1210
71899551|NCT01929044|143321711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0658|TWO_SIDED|95.0|-0.82|0.03|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||0.03|-0.82|0.0658
71679224|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.81||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||0.81|0.57|
71679225|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|1.18||||||95.0|0.98|1.41||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||1.41|0.98|
71899552|NCT01929044|143321712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.2||0.022|TWO_SIDED|95.0|-0.85|-0.07|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.07|-0.85|0.0220
71899553|NCT01929044|143321713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0149|TWO_SIDED|95.0|-0.81|-0.09|||Mixed Models Analysis|Kenward-Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|||-0.09|-0.81|0.0149
71899554|NCT01929044|143321714|SUPERIORITY_OR_OTHER|||||||0.0113|||||||van Elteren test|The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.||||||0.0113
71899555|NCT01929044|143321715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0992|TWO_SIDED|95.0|0.37|1.09|||Regression, Logistic|A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.|Exact 95% confidence interval obtained by Clopper and Pearson approach.|||1.09|0.37|0.0992
71816650|NCT01118455|143135711|SUPERIORITY_OR_OTHER|||||||0.691|||||||ANOVA|||||||0.691
71816651|NCT01118455|143135711|SUPERIORITY_OR_OTHER|||||||0.494|||||||ANOVA|||||||0.494
71816652|NCT01118455|143135711|SUPERIORITY_OR_OTHER|||||||0.343|||||||ANOVA|||||||0.343
71816653|NCT01118455|143135711|SUPERIORITY_OR_OTHER|||||||0.295|||||||ANOVA|||||||0.295
71816654|NCT03810313|143135744|NON_INFERIORITY|Non-inferiority was considered to be established if the lower limit of the corresponding 95% CI for the estimated between group difference (brolucizumab vs. aflibercept) on change from baseline in BCVA at Week 24 is \> -4 letters.|Least Square Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.2||0.173|TWO_SIDED|95.0|-5.2|-0.5|||ANOVA|||||-0.5|-5.2|0.173
71816655|NCT03029780|143135760|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|-12.3|12.3||||||||12.3|-12.3|
71816656|NCT03029780|143135760|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.39|||Cochran-Mantel-Haenszel|||||3.39|0.30|
71816657|NCT03029780|143135761|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||||0.00|0.00|
71848941|NCT00046475|143211735|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.011
71848942|NCT00046475|143211736|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
71848943|NCT00046475|143211736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||0.002
71848944|NCT00046475|143211736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.004
71816658|NCT03029780|143135762|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|5.8|||||TWO_SIDED|95.0|-13.3|24.8||||||||24.8|-13.3|
71816659|NCT03029780|143135762|SUPERIORITY||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.58|2.78|||Cochran-Mantel-Haenszel|||||2.78|0.58|
71816660|NCT03029780|143135763|SUPERIORITY||DIFFERENCE IN INCIDENCE RATES|7.7|||||TWO_SIDED|95.0|-10.1|25.5||||||||25.5|-10.1|
71816661|NCT03029780|143135763|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.62|3.24|||Cochran-Mantel-Haenszel|||||3.24|0.62|
71848945|NCT00046475|143211736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 5 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 5||||0.026
71848946|NCT00046475|143211736|SUPERIORITY_OR_OTHER_LEGACY|||||||0.226|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 6 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 6||||0.226
71848947|NCT00046475|143211737|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment composite symptom score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||0.002
71848948|NCT00046475|143211738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 1||||<0.001
71899556|NCT04436510|143321716|SUPERIORITY||Disease Rate Ratio|0.98|STANDARD_DEVIATION|0.118|||TWO_SIDED|95.0|0.769|1.237||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. verdiperstat slowed progression) was 0.57467. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by verdiperstat relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.237|0.769|
71899557|NCT04436510|143321718|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|2.054||0.8875|TWO_SIDED|95.0|-3.74|4.32|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||4.32|-3.74|0.8875
71899558|NCT04436510|143321719|SUPERIORITY||Mean Difference (Net)|3.57|STANDARD_ERROR_OF_MEAN|3.848||0.3538|TWO_SIDED|95.0|-3.99|11.13|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Verdiperstat 24-week change from baseline relative to placebo 24-week change from baseline.|||11.13|-3.99|0.3538
71899559|NCT04436510|143321720|SUPERIORITY|||||||0.318|||||||Log Rank|||||||0.318
71899560|NCT01663740|143321803|SUPERIORITY_OR_OTHER||Mean Difference|-40.166|STANDARD_ERROR_OF_MEAN|14.1387||0.0075|TWO_SIDED|95.0|-68.869|-11.463|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to EOT|||-11.463|-68.869|0.0075
71899561|NCT01663740|143321804|SUPERIORITY_OR_OTHER||Mean Difference|1.758|STANDARD_ERROR_OF_MEAN|2.646||0.5109|TWO_SIDED|95.0|-3.619|7.135|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to EOT|||7.135|-3.619|0.5109
71899562|NCT01663740|143321804|SUPERIORITY_OR_OTHER||Mean Difference|-1.051|STANDARD_ERROR_OF_MEAN|3.2058||0.7449|TWO_SIDED|95.0|-7.566|5.464|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to end of FU|||5.464|-7.566|0.7449
71899563|NCT01663740|143321805|SUPERIORITY_OR_OTHER||Mean Difference|2.869|STANDARD_ERROR_OF_MEAN|3.2934||0.394|TWO_SIDED|95.0|-4.001|9.739|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from EOT to end of FU|||9.739|-4.001|0.3940
71899564|NCT01663740|143321806|SUPERIORITY_OR_OTHER||Mean Difference|0.155|STANDARD_ERROR_OF_MEAN|0.3687||0.6773|TWO_SIDED|95.0|-0.594|0.903|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Basline to EOT|||0.903|-0.594|0.6773
71679226|NCT00373958|142876598|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.54|0.78||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.78|0.54|
71679227|NCT00373958|142876599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|0.1||||||95.0|-2.9|3.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||3.1|-2.9|
71679228|NCT00373958|142876599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.6||||||95.0|-8.3|7.0||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||7.0|-8.3|
71679229|NCT00373958|142876599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.4||||||95.0|-4.3|3.5||||||For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||3.5|-4.3|
71679230|NCT00373958|142876599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|1.7||||||95.0|-2.1|5.6||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.||5.6|-2.1|
71679231|NCT00373958|142876599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-0.9||||||95.0|-5.2|3.4||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.||3.4|-5.2|
71816662|NCT01460160|143135768|SUPERIORITY||Estimate of Difference|16.86||||0.032|TWO_SIDED|90.0|3.9|29.8||Superiority test versus AIEOP-BFM 2000|Chi-squared||Treatment difference (CA180372 - AIEOP-BFM 2000)|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control||29.8|3.9|0.032
71816663|NCT01460160|143135768|NON_INFERIORITY|non-inferiority margin = 5%. One-sided type I error rate of 0.05|Estimate of difference|6.91||||0.271|TWO_SIDED|90.0|-3.3|17.2||Superiority test versus EsPhALL|Chi-squared||Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%|Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control||17.2|-3.3|0.271
71679232|NCT00373958|142876599|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was \> -10%.|Difference|-2.1||||||95.0|-6.4|2.0||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.||2.0|-6.4|
71679233|NCT00373958|142876600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.||1.7|-1.6|
71679234|NCT00373958|142876600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.6||||||95.0|-7.1|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.||3.8|-7.1|
71679235|NCT00373958|142876600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|-0.8||||||95.0|-4.5|2.9||||||For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||2.9|-4.5|
71679236|NCT00373958|142876600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|3.6||||||95.0|-4.7|11.9||||||For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.||11.9|-4.7|
71679237|NCT00373958|142876600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -5%.|Difference|1.2||||||95.0|-4.4|6.9||||||For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.||6.9|-4.4|
71816664|NCT01460160|143135768|SUPERIORITY|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control|Estimate of difference|-10.75||||0.157|TWO_SIDED|90.0|-22.7|1.2|||Chi-squared||Treatment difference (CA180372 - COG AALL0031)|||1.2|-22.7|0.157
71848949|NCT00046475|143211738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2||||<0.001
71848950|NCT00046475|143211738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3||||<0.001
71848951|NCT00046475|143211738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4||||0.001
71848952|NCT00046475|143211739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with post-treatment global daily activity score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||||||<0.001
71816665|NCT01616771|143135774|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
71816666|NCT01616771|143135775|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||To verify the difference in C\&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges-Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C\&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C\&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.||||<0.05
71816667|NCT02387216|143135786|SUPERIORITY||Hazard Ratio (HR)|1.382||||0.2302|TWO_SIDED|95.0|0.813|2.35|||Log Rank|||||2.350|0.813|0.2302
71816668|NCT02387216|143135787|SUPERIORITY||Hazard Ratio (HR)|1.195||||0.5436|TWO_SIDED|95.0|0.673|2.122|||Log Rank|||||2.122|0.673|0.5436
71816669|NCT02387216|143135788|SUPERIORITY||Odds Ratio (OR)|4.3||||0.0455|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.0455
71816670|NCT02387216|143135789|SUPERIORITY|||||||0.2726|||||||Log Rank|||||||0.2726
71816671|NCT01381874|143135807|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.437|TWO_SIDED|95.0|0.816|1.603|||stratified log-rank test|||||1.603|0.816|0.437
71816672|NCT01381874|143135807|SUPERIORITY||Hazard Ratio (HR)|0.958||||0.794|TWO_SIDED|95.0|0.695|1.32|||stratified log-rank test|||||1.320|0.695|0.794
71816673|NCT01381874|143135808|SUPERIORITY||Hazard Ratio (HR)|1.074||||0.807|TWO_SIDED|95.0|0.608|1.896|||stratified log-rank test|||||1.896|0.608|0.807
71816674|NCT01381874|143135808|SUPERIORITY||Hazard Ratio (HR)|1.183||||0.542|TWO_SIDED|95.0|0.688|2.036|||stratified log-rank test|||||2.036|0.688|0.542
71679238|NCT00373958|142876600|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|4.8||||||95.0|-3.4|13.0||||||For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.||13.0|-3.4|
71816675|NCT01381874|143135809|SUPERIORITY||Risk Ratio (RR)|0.909||||1|TWO_SIDED|95.0|0.213|3.878|||Fisher Exact|||||3.878|0.213|1.000
71816676|NCT01381874|143135809|SUPERIORITY||Risk Ratio (RR)|1.909||||0.366|TWO_SIDED|95.0|0.605|6.026|||Fisher Exact|||||6.026|0.605|0.366
71816677|NCT01381874|143135810|SUPERIORITY||Risk Ratio (RR)|0.757||||0.603|TWO_SIDED|95.0|0.264|2.175|||Chi-squared|||||2.175|0.264|0.603
71816678|NCT01381874|143135810|SUPERIORITY||Risk Ratio (RR)|1.79||||0.137|TWO_SIDED|95.0|0.816|3.926|||Chi-squared|||||3.926|0.816|0.137
71816679|NCT02247804|143135814|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295|TWO_SIDED|95.0|-1.17|0.36|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.36|-1.17|0.2950
71816680|NCT02247804|143135814|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Change from Baseline Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.43|-1.09|0.3904
71816681|NCT02247804|143135814|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464|TWO_SIDED|95.0|-1.4|-0.01|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||-0.01|-1.40|0.0464
71848953|NCT00046475|143211742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing systolic blood pressure||||0.002
71848954|NCT00046475|143211742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline standing diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing diastolic blood pressure||||0.010
71848955|NCT00046475|143211743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine systolic blood pressure||||<0.001
71848956|NCT00046475|143211743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||The P-value is based on an ANOVA model with change from baseline supine diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine diastolic blood pressure||||0.002
71679239|NCT00373958|142876601|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.75|1.17||||||For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.75|
71679240|NCT00373958|142876602|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96|||||TWO_SIDED|95.0|0.85|1.08||||||For Measles the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.85|
71679241|NCT00373958|142876602|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.14||||||For Mumps the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.87|
71679242|NCT00373958|142876602|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01|||||TWO_SIDED|95.0|0.92|1.1||||||For Varicella the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.92|
71679243|NCT00373958|142876603|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78|||||TWO_SIDED|95.0|0.62|1.0||||||For Rubella the GMC ratio (13vPnC/7vPnC) was calculated||1.00|0.62|
71679244|NCT01552915|142876608|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-2.1|STANDARD_ERROR_OF_MEAN|1.15||0.0717|TWO_SIDED|95.0|-4.3|0.2|||mixed effects model for repeated measure|||||0.2|-4.3|0.0717
71679245|NCT01552915|142876608|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-12.2|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-15.1|-9.4|||mixed effects model for repeated measure|||||-9.4|-15.1|<0.0001
71679246|NCT01552915|142876608|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-10.1|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|-13.0|-7.3|||mixed effects model for repeated measure|||||-7.3|-13.0|<0.0001
71679247|NCT01552915|142876609|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6165|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.6165
71679248|NCT01552915|142876609|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71679249|NCT01552915|142876609|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.0001
71816682|NCT02247804|143135814|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383|TWO_SIDED|95.0|-0.9|0.47|||MMRM|||Change from Baseline Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Week 12).||0.47|-0.90|0.5383
71816683|NCT02247804|143135815|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
71816684|NCT02247804|143135815|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
71816685|NCT02247804|143135816|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057||95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
71679250|NCT03421145|142876615|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71679251|NCT03421145|142876616|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71679252|NCT03421145|142876617|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71679253|NCT03421145|142876618|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71679254|NCT03421145|142876619|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71679255|NCT02951533|142876626|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71679256|NCT05870956|142876680|OTHER||Mean Difference (Net)|932.88||||0.516|TWO_SIDED|95.0|-1880.17|3745.94|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||3745.94|-1880.17|0.516
71679257|NCT05870956|142876680|OTHER||Mean Difference (Net)|4902.02||||0.02|TWO_SIDED|95.0|767.6|9036.43|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||9036.43|767.60|0.020
71679258|NCT05870956|142876680|OTHER||Mean Difference (Net)|2727.38||||0.026|TWO_SIDED|95.0|323.48|5131.27|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5131.27|323.48|0.026
71679259|NCT05870956|142876680|OTHER||Mean Difference (Net)|5462.41||||0|TWO_SIDED|95.0|2520.93|8403.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8403.90|2520.93|0.000
71679260|NCT05870956|142876681|OTHER||Mean Difference (Net)|-303.94||||0.439|TWO_SIDED|95.0|-1074.77|466.9|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||466.90|-1074.77|0.439
71679261|NCT05870956|142876681|OTHER||Mean Difference (Net)|2772.06||||0.021|TWO_SIDED|95.0|422.1|5122.02|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5122.02|422.10|0.021
71679262|NCT05870956|142876681|OTHER||Mean Difference (Net)|456.79||||0.328|TWO_SIDED|95.0|-458.64|1372.21|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||1372.21|-458.64|0.328
71679263|NCT05870956|142876681|OTHER||Mean Difference (Net)|620.87||||0.382|TWO_SIDED|95.0|-771.77|2013.51|||ANOVA||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||2013.51|-771.77|0.382
71679264|NCT05870956|142876682|OTHER||Mean Difference (Net)|2.4||||0.463|TWO_SIDED|95.0|-4.0|8.9|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.9|-4.0|0.463
71679265|NCT05870956|142876682|OTHER||Mean Difference (Net)|9.6||||0.008|TWO_SIDED|95.0|2.5|16.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||16.8|2.5|0.008
71679266|NCT05870956|142876682|OTHER||Mean Difference (Net)|9.1||||0.005|TWO_SIDED|95.0|2.8|15.3|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||15.3|2.8|0.005
71679267|NCT05870956|142876682|OTHER||Mean Difference (Net)|6.4||||0.019|TWO_SIDED|95.0|1.1|11.7|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||11.7|1.1|0.019
71679268|NCT05870956|142876683|OTHER||Mean Difference (Net)|0.6||||0.801|TWO_SIDED|95.0|-4.3|5.5|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.5|-4.3|0.801
71816686|NCT02247804|143135816|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031||95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
71679269|NCT05870956|142876683|OTHER||Mean Difference (Net)|8.7||||0.005|TWO_SIDED|95.0|2.7|14.8|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||14.8|2.7|0.005
71679270|NCT05870956|142876683|OTHER||Mean Difference (Net)|3.4||||0.17|TWO_SIDED|95.0|-1.4|8.2|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||8.2|-1.4|0.170
71679271|NCT05870956|142876683|OTHER||Mean Difference (Net)|1.4||||0.489|TWO_SIDED|95.0|-2.6|5.4|||Chi-squared||"The net difference was calculated as:~Comparator - Reference~where High nintedanib adherence group was used as reference."|||5.4|-2.6|0.489
71679272|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.38|STANDARD_ERROR_OF_MEAN|5.449|||TWO_SIDED|95.0|-5.75|24.51|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||24.51|-5.75|
71679273|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Median Difference (Net)|7.55|STANDARD_ERROR_OF_MEAN|5.849|||TWO_SIDED|95.0|-8.68|23.79|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||23.79|-8.68|
71679274|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.92|STANDARD_ERROR_OF_MEAN|3.645|||TWO_SIDED|95.0|-12.04|8.2|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||8.20|-12.04|
71679275|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.21|STANDARD_ERROR_OF_MEAN|6.361|||TWO_SIDED|95.0|-3.45|31.87|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||31.87|-3.45|
71679276|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|3.79|||TWO_SIDED|95.0|-10.12|10.92|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||10.92|-10.12|
71899565|NCT01663740|143321806|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3343||0.7046|TWO_SIDED|95.0|-0.806|0.551|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Baseline to end of FU|||0.551|-0.806|0.7046
71679277|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|25.04|STANDARD_ERROR_OF_MEAN|4.281|||TWO_SIDED|95.0|13.16|36.93|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||36.93|13.16|
71679278|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|10.62||||95.0|-29.94|29.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||29.03|-29.94|
71679279|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31|STANDARD_ERROR_OF_MEAN|7.194|||TWO_SIDED|95.0|-11.67|28.28|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||28.28|-11.67|
71679280|NCT00742508|142876693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.142|||TWO_SIDED|95.0|-0.63|0.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.15|-0.63|
71679281|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|4.833|||TWO_SIDED|95.0|-11.2|15.63|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||15.63|-11.20|
71679282|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|6.265|||TWO_SIDED|95.0|-17.95|16.84|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||16.84|-17.95|
71679283|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.93|STANDARD_ERROR_OF_MEAN|3.885|||TWO_SIDED|95.0|-15.71|5.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||5.86|-15.71|
71679284|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|6.07|||TWO_SIDED|95.0|-7.11|26.59|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||26.59|-7.11|
71679285|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.45|STANDARD_ERROR_OF_MEAN|4.08|||TWO_SIDED|95.0|-14.78|7.88|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||7.88|-14.78|
71816687|NCT02247804|143135817|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547||95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
71816688|NCT02247804|143135817|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107||95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
71816689|NCT02247804|143135818|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.32||0.086||95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
71816690|NCT02247804|143135818|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
71679286|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.06|STANDARD_ERROR_OF_MEAN|1.694|||TWO_SIDED|95.0|13.36|22.76|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||22.76|13.36|
71679287|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.46|STANDARD_ERROR_OF_MEAN|8.902|||TWO_SIDED|95.0|-32.17|17.26|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||17.26|-32.17|
71816691|NCT02247804|143135819|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.39||0.295||95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.36|-1.17|0.2950
71816692|NCT02247804|143135819|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.39||0.3904|TWO_SIDED|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.43|-1.09|0.3904
71816693|NCT02247804|143135820|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.0464||95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.01|-1.40|0.0464
71816694|NCT02247804|143135820|NON_INFERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.35||0.5383||95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared non-inferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.47|-0.90|0.5383
71816695|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.34||0.0033|TWO_SIDED|95.0|-1.68|-0.34|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.34|-1.68|0.0033
71816696|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0187|TWO_SIDED|95.0|-1.47|-0.13|||MMRM|||Change from Baseline Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.13|-1.47|0.0187
71816697|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.31||0.0057|TWO_SIDED|95.0|-1.45|-0.25|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.25|-1.45|0.0057
71816698|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.0031|TWO_SIDED|95.0|-1.5|-0.31|||MMRM|||Change from Baseline Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.31|-1.50|0.0031
71848957|NCT00046475|143211744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 general health score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of general health||||0.569
71816699|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.32||0.0547|TWO_SIDED|95.0|-1.26|0.01|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.01|-1.26|0.0547
71848958|NCT00046475|143211744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.578|TWO_SIDED|||||The P-value is based on an ANOVA model with SF-36 physical functioning score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of physical functioning||||0.578
71899566|NCT01663740|143321807|SUPERIORITY_OR_OTHER||Mean Difference|-0.128|STANDARD_ERROR_OF_MEAN|0.3684||0.7323|TWO_SIDED|95.0|-0.888|0.633|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from EOT to end of FU|||0.633|-0.888|0.7323
71816700|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0107|TWO_SIDED|95.0|-1.46|-0.19|||MMRM|||Change from Baseline Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.19|-1.46|0.0107
71816701|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.32||0.086|TWO_SIDED|95.0|-1.16|0.08|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||0.08|-1.16|0.0860
71816702|NCT02247804|143135821|SUPERIORITY|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Change from Baseline Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared superior to timolol 0.5% if the upper limit of the 95% CI was \< 0 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).||-0.04|-1.27|0.0362
71816703|NCT02917265|143135832|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71816704|NCT00114634|143135891|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71816705|NCT00007475|143135943|SUPERIORITY_OR_OTHER||Proportion with reduced proteinuria|0.6363|STANDARD_ERROR_OF_MEAN|0.0698|<|0.0001|TWO_SIDED|95.0|0.3079|0.8907||Exact binomial test of proportion of participants exhibiting reduction in proteinuria (see definition below), under null hypothesis that the overall proportion is zero.|Exact binomial test|Tested under null hypothesis that the overall proportion is zero.|Proportion event definition: exhibiting reduction in proteinuria post-cyclophosphamide (complete- \[urine protein {UP} \<0.3\] or or partial-remission \[between 0.3 \& 2.0, inclusive\], limited response \[UP between 2.0 \& 3.5\] yet no relapse \[UP 3.5+\]).|No groups compared, yet null hypothesis: pooled proportion = 0, tested using counts pooled across baseline FPF assay-availability groups (7 across 3 arms) excluding 4 non-completers (yielding 7/11 with event below). Given the modest group-specific sample sizes and tendency for zero outcomes to be observed in a group, we employ exact binomial 95% confidence intervals using the method of Clopper and Pearson (1934; calculated along with corresponding tests using Michael Fay's exactci package in R).||0.8907|0.3079|<0.0001
71816706|NCT00936221|143135958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3873|TWO_SIDED|80.0|0.67|1.28||1-sided p-value|Regression, Cox|Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.||If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.||1.28|0.67|0.3873
71816707|NCT03820323|143135962|SUPERIORITY||Risk Ratio (RR)|0.99||||0.55|TWO_SIDED|95.0|0.94|1.03|||Modified Poisson regression|||||1.03|0.94|0.55
71816708|NCT03820323|143135963|SUPERIORITY||Risk Ratio (RR)|0.86||||0.28|TWO_SIDED|95.0|0.66|1.13|||Modified Poission regression|||||1.13|0.66|0.28
71816709|NCT00879996|143135987|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9134||||0.77|TWO_SIDED|95.0|0.4156|2.007|||Log Rank|||Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.||2.007|0.4156|0.77
71816710|NCT00879996|143135988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||<|0.043||95.0|||||ANOVA|||Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.||||<0.043
71816711|NCT00879996|143135989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.0|<|0.665|TWO_SIDED|95.0|||||ANOVA|||null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.||||<0.665
71816712|NCT00879996|143135990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|STANDARD_DEVIATION|0.0|<|0.039|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.||||<0.039
71816713|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|40.95|STANDARD_ERROR_OF_MEAN|19.38||0.035|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression||The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.|The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope \& intercept model. The analysis included the fixed, categorical effects of treatment, ATA status \& gender, fixed continuous effects of time \& baseline FVC (mL), age and height as well as the treatment-by time \& baseline-by-time interactions. Random effects was included for patient response for both time \& intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix||79.01|2.88|0.0350
71816714|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|43.13||||0.0378|TWO_SIDED|95.0|2.44|83.83|||random coefficient regression|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC \[mL\]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status \& gender, fixed continuous effects of time \& bl. FVC (mL), age, height, trt -by time \& bl.-by-time interactions. Random effects included for patient response for both time \& intercept.~Within-patient errors were modelled by an Unstructured variance-covariance matrix."||83.83|2.44|0.0378
71848959|NCT00046475|143211748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with mild or moderate disease severity||||0.370
71899567|NCT01663740|143321808|SUPERIORITY_OR_OTHER||Mean Difference|51.267|STANDARD_ERROR_OF_MEAN|36.6869||0.1756|TWO_SIDED|95.0|-24.626|127.159|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from EOT to end of FU|||127.159|-24.626|0.1756
71899568|NCT01663740|143321809|SUPERIORITY_OR_OTHER||Mean Difference|-10.195|STANDARD_ERROR_OF_MEAN|19.5745||0.6058|TWO_SIDED|95.0|-49.934|29.543|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,\& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to end of FU|||29.543|-49.934|0.6058
71899569|NCT01663740|143321810|SUPERIORITY_OR_OTHER||Mean Difference|-21.828|STANDARD_ERROR_OF_MEAN|9.1214||0.0222|TWO_SIDED|95.0|-40.346|-3.311|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to EOT|||-3.311|-40.346|0.0222
71899570|NCT01663740|143321810|SUPERIORITY_OR_OTHER||Mean Difference|-9.802|STANDARD_ERROR_OF_MEAN|8.3702||0.2495|TWO_SIDED|95.0|-26.795|7.19|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to end of FU|||7.190|-26.795|0.2495
71899571|NCT01663740|143321811|SUPERIORITY_OR_OTHER||Mean Difference|-11.683|STANDARD_ERROR_OF_MEAN|12.2576||0.3505|TWO_SIDED|95.0|-37.039|13.674|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from EOT to end of FU|||13.674|-37.039|0.3505
71899572|NCT01663740|143321812|SUPERIORITY_OR_OTHER||Mean Difference|-5.741|STANDARD_ERROR_OF_MEAN|6.7578||0.4021|TWO_SIDED|95.0|-19.524|8.042|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to EOT|||8.042|-19.524|0.4021
71848960|NCT00046475|143211749|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|TWO_SIDED|||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with marked or severe disease severity||||0.007
71848961|NCT02203032|143211759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
71816715|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|30.0||||0.1046|TWO_SIDED|95.0|-6.22|66.22|||random coefficient regression|||In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.||66.22|-6.22|0.1046
71816716|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|32.93||||0.074|TWO_SIDED|95.0|-3.19|69.06|||random coefficient regression|||In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA||69.06|-3.19|0.0740
71816717|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|33.86||||0.0644|TWO_SIDED|95.0|-2.03|69.75|||random coefficient regression|||In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.||69.75|-2.03|0.0644
71816718|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|40.95||||0.0351|TWO_SIDED|95.0|2.88|79.01|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.||79.01|2.88|0.0351
71848962|NCT02203032|143211760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
71848963|NCT02203032|143211761|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Row mean score test|||||||< 0.001
71848964|NCT02203032|143211762|SUPERIORITY_OR_OTHER||||||=|0.001|||||||Cochran-Mantel-Haenszel|||||||= 0.001
71848965|NCT01915914|143211763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|13.4993|||<|0.0001|TWO_SIDED|95.0|4.1113|44.325|||Log Rank|||||44.3250|4.1113|<0.0001
71848966|NCT01915914|143211764|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.9524|||<|0.0001|TWO_SIDED|95.0|2.4258|10.1105|||Log Rank|||||10.1105|2.4258|<0.0001
71848967|NCT01915914|143211765|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||||||<0.0001
71848968|NCT01915914|143211766|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71848969|NCT01915914|143211768|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71848970|NCT01915914|143211769|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71848971|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.701||95.0||||Week 20, CA|Wilcoxon (Mann-Whitney)|||||||0.7010
71848972|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||Week 20, ET/L|Wilcoxon (Mann-Whitney)|||||||0.0042
71848973|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.081||95.0||||Week 20, AP|Wilcoxon (Mann-Whitney)|||||||0.0810
71848974|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.2799||95.0||||Week 32, CA|Wilcoxon (Mann-Whitney)|||||||0.2799
71848975|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.1375||95.0||||Week 32, ET/L|Wilcoxon (Mann-Whitney)|||||||0.1375
71848976|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||Week 32, AP|Wilcoxon (Mann-Whitney)|||||||0.1100
71816719|NCT02597933|143135994|OTHER||Mean Difference (Final Values)|40.98||||0.0349|TWO_SIDED|95.0|2.92|79.04|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept||79.04|2.92|0.0349
71816720|NCT02597933|143135995|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.37||0.5785|TWO_SIDED|95.0|-0.94|0.53|||MMRM|||The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||0.53|-0.94|0.5785
71816721|NCT02597933|143135996|OTHER||Mean Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|1.24||0.1711|TWO_SIDED|95.0|-0.73|4.12|||MMRM|The MMRM model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||4.12|-0.73|0.1711
71816722|NCT02597933|143135997|OTHER||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.54||0.0331|TWO_SIDED|1.15|0.09|2.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||"Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC \[% pred\], \& including treatment-by-time and baseline-by-time interactions. Random effect was included for patient specific intercept \& time.~Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-Components variance-covariance matrix."||2.21|0.09|0.0331
71816723|NCT02597933|143135998|OTHER||Mean Difference (Final Values)|46.41|STANDARD_ERROR_OF_MEAN|19.51||0.0177|TWO_SIDED|95.0|8.09|84.73|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||84.73|8.09|0.0177
71816724|NCT02597933|143135999|OTHER||Mean Difference (Final Values)|-6.28|STANDARD_ERROR_OF_MEAN|8.39||0.4547|TWO_SIDED|95.0|-22.77|10.21|||MMRM|The model assumed that data were missing at random \& that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||10.21|-22.77|0.4547
71816725|NCT02597933|143136000|OTHER||Hazard Ratio (HR)|1.16||||0.7535|TWO_SIDED|95.0|0.47|2.84|||Regression, Cox|Based on Cox's regression model (Wald test), stratified by ATA status.||||2.84|0.47|0.7535
71816726|NCT02597933|143136001|OTHER||Odds Ratio (OR)|1.03||||0.9115|TWO_SIDED|95.0|0.57|1.88|||Cochran-Mantel-Haenszel|||The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.|Missing values were imputed using worst case, i.e. considered having disease progression.|1.88|0.57|0.9115
71816727|NCT02597933|143136002|OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.76||0.5668|TWO_SIDED|95.0|-1.94|1.06|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.06|-1.94|0.5668
71848977|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.0394||95.0||||Week 20, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.0394
71848978|NCT01915914|143211774|SUPERIORITY_OR_OTHER|||||||0.2237||95.0||||Week 32, Total VAS Score|Wilcoxon (Mann-Whitney)|||||||0.2237
71848979|NCT02432274|143211793|OTHER||||||=|0.20359|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.20359
71848980|NCT02432274|143211793|OTHER||||||=|0.50068|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)||||=0.50068
71848981|NCT02432274|143211793|OTHER||||||=|0.05512|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 19 (PFS-4, Yes) vs. C3D1: FGF 19 (PFS-4, No)||||=0.05512
71848982|NCT02432274|143211793|OTHER||||||=|0.50382|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 19 (PFS-4, Yes) vs. C4D1: FGF 19 (PFS-4, No)||||=0.50382
71848983|NCT02432274|143211793|OTHER||||||=|0.0476|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.04760
71848984|NCT02432274|143211793|OTHER||||||=|0.2142|||||||Wilcoxon Rank-Sum Test|||C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)||||=0.21420
71848985|NCT02432274|143211793|OTHER||||||=|0.42542|||||||Wilcoxon Rank-Sum Test|||C3D1: FGF 21 (PFS-4, Yes) vs. C3D1: FGF 21 (PFS-4, No)||||=0.42542
71848986|NCT02432274|143211793|OTHER||||||=|0.73573|||||||Wilcoxon Rank-Sum Test|||C4D1: FGF 21 (PFS-4, Yes) vs. C4D1: FGF 21 (PFS-4, No)||||=0.73573
71848987|NCT02432274|143211793|OTHER||||||=|0.35754|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.35754
71848988|NCT02432274|143211793|OTHER||||||=|0.59903|||||||Wilcoxon Rank-Sum Test|||C2D1: VEGF (PFS-4, Yes) vs. C2D1: VEGF (PFS-4, No)||||=0.59903
71848989|NCT02432274|143211793|OTHER||||||=|1|||||||Wilcoxon Rank-Sum Test|||C3D1: VEGF (PFS-4, Yes) vs. C3D1: VEGF (PFS-4, No)||||=1.00000
71848990|NCT00286325|143211818|SUPERIORITY_OR_OTHER||||||=|0.0156||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon comparing week zero antibody value in units to week 24 antibody value in units||||=0.0156
71899573|NCT01663740|143321812|SUPERIORITY_OR_OTHER||Mean Difference|-1.854|STANDARD_ERROR_OF_MEAN|5.1817||0.7229|TWO_SIDED|95.0|-12.423|8.714|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to end of FU|||8.714|-12.423|0.7229
71899574|NCT01663740|143321813|SUPERIORITY_OR_OTHER||Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|7.7598||0.708|TWO_SIDED|95.0|-19.192|13.291|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from EOT to end of FU|||13.291|-19.192|0.7080
71899575|NCT01663740|143321814|SUPERIORITY_OR_OTHER||Mean Difference|-1.861|STANDARD_ERROR_OF_MEAN|1.6512||0.2673|TWO_SIDED|95.0|-5.213|1.491|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to EOT|||1.491|-5.213|0.2673
71899576|NCT01663740|143321814|SUPERIORITY_OR_OTHER||Mean Difference|-1.114|STANDARD_ERROR_OF_MEAN|1.6147||0.4949|TWO_SIDED|95.0|-4.392|2.164|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to end of FU|||2.164|-4.392|0.4949
71899577|NCT01663740|143321815|SUPERIORITY_OR_OTHER||Mean Difference|0.047|STANDARD_ERROR_OF_MEAN|1.51||0.9753|TWO_SIDED|95.0|-3.063|3.157|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from EOT to end of FU|||3.157|-3.063|0.9753
71899578|NCT01663740|143321816|SUPERIORITY_OR_OTHER||Mean Difference|0.076|STANDARD_ERROR_OF_MEAN|0.6347||0.9053|TWO_SIDED|95.0|-1.214|1.366|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to EOT|||1.366|-1.214|0.9053
71899579|NCT01663740|143321816|SUPERIORITY_OR_OTHER||Mean Difference|-1.215|STANDARD_ERROR_OF_MEAN|0.4477||0.0104|TWO_SIDED|95.0|-2.125|-0.305|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to end of FU|||-0.305|-2.125|0.0104
71899580|NCT01663740|143321817|SUPERIORITY_OR_OTHER||Mean Difference|-1.065|STANDARD_ERROR_OF_MEAN|0.4057||0.0143|TWO_SIDED|95.0|-1.899|-0.231|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,\& pre-transplant dialysis duration as explanatory variables.|Change in LH level from EOT to end of FU|||-0.231|-1.899|0.0143
71899581|NCT01663740|143321818|SUPERIORITY_OR_OTHER||Mean Difference|2.541|STANDARD_ERROR_OF_MEAN|1.7274||0.1505|TWO_SIDED|95.0|-0.969|6.052|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to EOT|||6.052|-0.969|0.1505
71899582|NCT01663740|143321818|SUPERIORITY_OR_OTHER||Mean Difference|-0.983|STANDARD_ERROR_OF_MEAN|0.6739||0.1539|TWO_SIDED|95.0|-2.352|0.387|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to end of FU|||0.387|-2.352|0.1539
71899583|NCT01663740|143321819|SUPERIORITY_OR_OTHER||Mean Difference|-1.474|STANDARD_ERROR_OF_MEAN|0.8084||0.0798|TWO_SIDED|95.0|-3.136|0.188|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from EOT to end of FU|||0.188|-3.136|0.0798
71848991|NCT00286325|143211819|SUPERIORITY_OR_OTHER||||||=|0.0078|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of B cell number at week 0 to b cell number in participants at week 24||||=0.0078
71848992|NCT01213940|143211848|EQUIVALENCE|95% confidence limit from standard deviation of mean|||||<|0.05|||||||ANOVA|||one -way ANOVA was used for the analysis||||<0.05
71848993|NCT02725372|143211849|SUPERIORITY||Mean Difference (Final Values)|1.99||||0.87|TWO_SIDED|95.0|-22.47|26.45|||Mixed Models Analysis|||||26.45|-22.47|0.87
71848994|NCT02725372|143211850|SUPERIORITY|||||||0.55|||||||Log Rank|||||||0.55
71848995|NCT02725372|143211852|SUPERIORITY||Mean Difference (Final Values)|-89.1||||0.01|TWO_SIDED|95.0|-156.0|-22.1|||ANCOVA|||||-22.1|-156.0|0.01
71848996|NCT02725372|143211853|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.47|TWO_SIDED|95.0|-0.89|0.41|||ANCOVA|||||0.41|-0.89|0.47
71848997|NCT02725372|143211854|SUPERIORITY||Odds Ratio (OR)|1.05||||0.26|TWO_SIDED|95.0|0.48|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.48|0.26
71848998|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71848999|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849000|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849001|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
71849002|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849003|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71816728|NCT02597933|143136003|OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.5914|TWO_SIDED|95.0|-0.16|0.09|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.09|-0.16|0.5914
71816729|NCT02597933|143136004|OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.034||0.3447|TWO_SIDED|95.0|-0.035|0.099|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||0.099|-0.035|0.3447
71816730|NCT02597933|143136005|OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.58||0.2727|TWO_SIDED|95.0|-0.51|1.79|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.||1.79|-0.51|0.2727
71816731|NCT01097915|143136016|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||||||<0.01
71816732|NCT01097915|143136017|SUPERIORITY_OR_OTHER||||||<|0.004|||||||ANOVA|||||||<0.004
71816733|NCT01097915|143136018|SUPERIORITY_OR_OTHER||||||<|0.048|||||||ANCOVA|the three factors of the Stunkard and Messick Questionnaire were considered as covariates.||||||<0.048
71816734|NCT01097915|143136019|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
71816735|NCT01097915|143136020|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||ANOVA|||||||< 0.00001
71899584|NCT01663740|143321820|SUPERIORITY_OR_OTHER||Mean Difference|-0.104|STANDARD_ERROR_OF_MEAN|23.466||0.9965|TWO_SIDED|95.0|-47.792|47.585|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to EOT|||47.585|-47.792|0.9965
71679288|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|5.297|||TWO_SIDED|95.0|-13.61|15.8|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||15.80|-13.61|
71679289|NCT00742508|142876713|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.54|0.3|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.30|-0.54|
71816736|NCT01097915|143136021|SUPERIORITY_OR_OTHER||||||<|1e-05|||||||Chi-squared|||||||< 0.00001
71816737|NCT01107743|143136027|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.812|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.812
71849004|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849005|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71816738|NCT01107743|143136028|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
71816739|NCT01107743|143136029|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
71816740|NCT01107743|143136030|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.112
71816741|NCT01107743|143136031|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.093|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.093
71816742|NCT01107743|143136032|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
71816743|NCT01107743|143136033|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.839|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.839
71816744|NCT01107743|143136034|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
71816745|NCT01107743|143136035|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=1.000
71849006|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|-2.2|||||TWO_SIDED|95.0|-15.7|10.9||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-15.7|
71849007|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71679290|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.99|STANDARD_ERROR_OF_MEAN|3.187|||TWO_SIDED|95.0|-12.84|4.86|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the 24 h assessment.|||4.86|-12.84|
71679291|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.27|STANDARD_ERROR_OF_MEAN|2.962|||TWO_SIDED|95.0|-13.5|2.95|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Morning assessment.|||2.95|-13.50|
71679292|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.98|STANDARD_ERROR_OF_MEAN|3.209|||TWO_SIDED|95.0|-10.89|6.94|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Afternoon assessment.|||6.94|-10.89|
71679293|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.14|STANDARD_ERROR_OF_MEAN|3.665|||TWO_SIDED|95.0|-14.32|6.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Night assessment.|||6.03|-14.32|
71679294|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.99|STANDARD_ERROR_OF_MEAN|3.047|||TWO_SIDED|95.0|-11.45|5.47|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Waking assessment.|||5.47|-11.45|
71679295|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.11|STANDARD_ERROR_OF_MEAN|4.686|||TWO_SIDED|95.0|-16.12|9.89|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the Sleeping assessment.|||9.89|-16.12|
71679296|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.0|STANDARD_ERROR_OF_MEAN|3.749|||TWO_SIDED|95.0|-20.41|0.41|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax assessment.|||0.41|-20.41|
71679297|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.42|STANDARD_ERROR_OF_MEAN|5.249|||TWO_SIDED|95.0|-16.0|13.15|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmin assessment.|||13.15|-16.00|
71679298|NCT00742508|142876714|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.71|0.03|||||The mean treatment difference is calculated as SK\&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.|||0.03|-0.71|
71679299|NCT04017832|142876718|SUPERIORITY||Mean Difference (Net)|-0.2||||0.0078|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.1|-0.3|0.0078
71899585|NCT01663740|143321820|SUPERIORITY_OR_OTHER||Mean Difference|15.272|STANDARD_ERROR_OF_MEAN|20.6031||0.4636|TWO_SIDED|95.0|-26.599|57.142|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to end of FU|||57.142|-26.599|0.4636
71899586|NCT01663740|143321821|SUPERIORITY_OR_OTHER||Mean Difference|8.74|STANDARD_ERROR_OF_MEAN|17.0805||0.6134|TWO_SIDED|95.0|-26.438|43.917|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from EOT to end of FU|||43.917|-26.438|0.6134
71679300|NCT04017832|142876718|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.6||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.6|-0.8|<0.0001
71679301|NCT04017832|142876718|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||Unadjusted two-sided p-value|Mixed model for repeated measurements|||||-0.8|-1.1|< 0.0001
71679302|NCT05129293|142876762|SUPERIORITY|||||||0.229|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.229
71679303|NCT05129293|142876763|SUPERIORITY|||||||0.04|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.040
71679304|NCT05129293|142876764|SUPERIORITY|||||||0.266|||||||ANCOVA|Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance||||||0.266
71679305|NCT00860249|142876765|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
71679306|NCT00860249|142876766|SUPERIORITY_OR_OTHER||||||<|0.017||95.0||||We intended to use a Bonferroni calculation to adjust for multiple comparisons among study arms.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.||||<0.017
71679307|NCT00174967|142876767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679308|NCT00174967|142876767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679309|NCT00174967|142876767|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679310|NCT00174967|142876768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679311|NCT00174967|142876768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679312|NCT00174967|142876768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71816746|NCT01107743|143136036|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.644|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.644
71816747|NCT01107743|143136037|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.155|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.155
71816748|NCT01107743|143136038|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.305|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."||||=0.305
71816749|NCT01107743|143136039|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.234|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.234
71816750|NCT01107743|143136040|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.439|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.439
71816751|NCT01107743|143136041|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.761|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders."||||=0.761
71816752|NCT01107743|143136042|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
71899587|NCT01663740|143321822|SUPERIORITY_OR_OTHER||Mean Difference|8.142|STANDARD_ERROR_OF_MEAN|11.9301||0.5002|TWO_SIDED|95.0|-16.223|32.506|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to EOT|||32.506|-16.223|0.5002
71899588|NCT01663740|143321822|SUPERIORITY_OR_OTHER||Mean Difference|40.682|STANDARD_ERROR_OF_MEAN|17.6084||0.0279|TWO_SIDED|95.0|4.72|76.643|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to end of FU|||76.643|4.720|0.0279
71679313|NCT00174967|142876769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679314|NCT00174967|142876769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71816753|NCT01107743|143136043|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.31|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.310
71816754|NCT01107743|143136044|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.251|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.251
71816755|NCT01107743|143136045|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.756|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.756
71816756|NCT01107743|143136046|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.706|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.706
71816757|NCT01107743|143136047|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.192|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.192
71816758|NCT01107743|143136048|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.005|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders."||||=0.005
71816759|NCT01107743|143136049|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=1.000
71816760|NCT01107743|143136050|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.596|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.596
71816761|NCT01107743|143136051|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.252
71816762|NCT01107743|143136052|SUPERIORITY_OR_OTHER_LEGACY||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=1.000
71816763|NCT01107743|143136053|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.518|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."||||=0.518
71816764|NCT01107743|143136054|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.645|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between \<65 years and \>=65 years in the participants of responders."||||=0.645
71899589|NCT01663740|143321823|SUPERIORITY_OR_OTHER||Mean Difference|25.881|STANDARD_ERROR_OF_MEAN|22.1348||0.2548|TWO_SIDED|95.0|-20.024|71.786|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables|Change in inhibin B level from EOT to end of FU|||71.786|-20.024|0.2548
71899590|NCT01663740|143321824|SUPERIORITY_OR_OTHER||Difference in Percentage|14.3|||||TWO_SIDED|95.0|-19.3|45.3|||||Change in abnormal to abnormal sperm density from Baseline to EOT|||45.3|-19.3|
71899591|NCT01663740|143321824|SUPERIORITY_OR_OTHER||Difference in Percentage|5.0|||||TWO_SIDED|95.0|-34.3|43.3|||||Change in abnormal to abnormal sperm density from Baseline to end of FU|||43.3|-34.3|
71899592|NCT01663740|143321824|SUPERIORITY_OR_OTHER||Difference in Percentage|17.9|||||TWO_SIDED|95.0|-15.3|48.8|||||Change in normal to abnormal sperm density from Baseline to EOT|||48.8|-15.3|
71899593|NCT01663740|143321825|SUPERIORITY_OR_OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-34.5|42.5|||||Change in abnormal to abnormal sperm density from EOT to end of FU|||42.5|-34.5|
71899594|NCT01663740|143321826|SUPERIORITY_OR_OTHER||Difference in Percentage|1.3|||||TWO_SIDED|95.0|-31.3|33.7|||||Improvement from Baseline to EOT|||33.7|-31.3|
71899595|NCT01663740|143321826|SUPERIORITY_OR_OTHER||Difference in Percentage|6.7|||||TWO_SIDED|95.0|-31.1|44.4|||||Improvement from Baseline to end of FU|||44.4|-31.1|
71899596|NCT01663740|143321827|SUPERIORITY_OR_OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-50.0|29.3|||||Improvement from EOT to end of FU|||29.3|-50.0|
71899597|NCT01663740|143321828|SUPERIORITY_OR_OTHER||Difference in Percentage|-31.0|||||TWO_SIDED|95.0|-59.7|2.7|||||Improvement from Baseline to EOT|||2.7|-59.7|
71899598|NCT01663740|143321828|SUPERIORITY_OR_OTHER||Difference in Percentage|10.0|||||TWO_SIDED|95.0|-29.7|47.7|||||Improvement from Baseline to end of FU|||47.7|-29.7|
71899599|NCT01663740|143321829|SUPERIORITY_OR_OTHER||Difference in Percentage|-9.9|||||TWO_SIDED|95.0|-47.2|27.9|||||Improvement from EOT to end of FU|||27.9|-47.2|
71899600|NCT02574312|143321864|NON_INFERIORITY|Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.||||||0.028|||||||t-test, 1 sided|||||||0.028
71899601|NCT02078713|143321923|SUPERIORITY||Odds Ratio (OR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.22|0.65|0.46
71899602|NCT02078713|143321923|SUPERIORITY||Odds Ratio (OR)|0.79||||0.16|TWO_SIDED|95.0|0.57|1.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.10|0.57|0.16
71899603|NCT02078713|143321924|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.05|1.03|0.03
71899604|NCT02078713|143321925|SUPERIORITY||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.11|2.33||P-value calculated in imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||2.33|1.11|0.01
71899605|NCT02078713|143321926|SUPERIORITY||Odds Ratio (OR)|1.11||||0.62|TWO_SIDED|95.0|0.74|1.67||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.67|0.74|0.62
71899606|NCT02078713|143321927|SUPERIORITY||Relative risk ratio|1.1||||0.85|TWO_SIDED|95.0|0.4|3.04||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had been less involved to right amount (ref)||3.04|0.40|0.85
71899607|NCT02078713|143321927|SUPERIORITY||Relative risk ratio|1.6||||0.24|TWO_SIDED|95.0|0.73|3.5||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)||3.50|0.73|0.24
71899608|NCT02078713|143321928|SUPERIORITY||Relative risk ratio|1.0||||0.997|TWO_SIDED|95.0|0.45|2.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).||2.25|0.45|0.997
71899609|NCT02078713|143321928|SUPERIORITY||Relative risk ratio|0.69||||0.16|TWO_SIDED|95.0|0.41|1.16||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).||1.16|0.41|0.16
71899610|NCT02078713|143321929|SUPERIORITY|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|Odds Ratio (OR)|1.3||||0.13|TWO_SIDED|95.0|0.93|1.82||P-value calculated in multiply imputed dataset.|Regression, Logistic||The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.82|0.93|0.13
71899611|NCT02078713|143321930|SUPERIORITY||Relative risk ratio|1.13||||0.5|TWO_SIDED|95.0|0.79|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patient decision to both (ref)||1.61|0.79|0.50
71899612|NCT02078713|143321930|SUPERIORITY||Relative risk ratio|2.14||||0.09|TWO_SIDED|95.0|0.89|5.15||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of provider decision to both (ref)||5.15|0.89|0.09
71679315|NCT00174967|142876769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71899613|NCT02078713|143321931|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.71|0.94|0.12
71899614|NCT02078713|143321932|SUPERIORITY||Odds Ratio (OR)|1.18||||0.41|TWO_SIDED|95.0|0.8|1.74||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of overall score||1.74|0.80|0.41
71899615|NCT02078713|143321932|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0496|TWO_SIDED|95.0|1.0|1.8|||Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of informed decision subscale||1.80|1.00|0.0496
71899616|NCT02078713|143321932|SUPERIORITY||Odds Ratio (OR)|1.45||||0.03|TWO_SIDED|95.0|1.03|2.05||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of uncertainty subscale of DCS||2.05|1.03|0.03
71679316|NCT00174967|142876770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71899617|NCT02078713|143321932|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5|TWO_SIDED|95.0|0.8|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of effective decision subscale||1.59|0.80|0.5
71899618|NCT02078713|143321932|SUPERIORITY||Odds Ratio (OR)|1.17||||0.31|TWO_SIDED|95.0|0.86|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of values clarity subscale||1.59|0.86|0.31
71899619|NCT02078713|143321932|SUPERIORITY||Odds Ratio (OR)|1.06||||0.73|TWO_SIDED|95.0|0.76|1.49||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of support subscale||1.49|0.76|0.73
71679317|NCT00174967|142876770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71816765|NCT01107743|143136055|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.13|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders."||||=0.130
71816766|NCT01107743|143136056|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.185|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."||||=0.185
71816767|NCT01107743|143136057|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.714|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."||||=0.714
71816768|NCT01107743|143136058|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.835|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."||||=0.835
71816769|NCT01107743|143136059|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.252|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."||||=0.252
71816770|NCT00308737|143136060|NON_INFERIORITY_OR_EQUIVALENCE|Comparison of TI + Usual Care to Usual Care only|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.014|0.06|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate||0.060|0.014|
71816771|NCT00308737|143136061|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the FEV1 change from Baseline for the TI group is no greater than 50 mL/year above the change in the usual care treatment group. Assuming SD of 100 mL/y, 80% power, and 5% (1-tailed) significance level, it was determined that 50 subjects were required for each of the diabetes treatment groups. Final sample size was selected for the incidence of a \>= 15% decrease in FEV1 end point.|Mean Difference (Final Values)|0.037|||||TWO_SIDED|95.0|0.016|0.057|||ANCOVA|||ANCOVA model with treatment site, diabetes type, and baseline FEV1||0.057|0.016|
71816772|NCT00308737|143136062|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.034|||||TWO_SIDED|95.0|0.008|0.061|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FVC as a covariate||0.061|0.008|
71816773|NCT00308737|143136063|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|||||TWO_SIDED|95.0|-0.042|0.031|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.031|-0.042|
71816774|NCT00308737|143136064|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|||||TWO_SIDED|95.0|-0.037|0.574|||Mixed Models Analysis|Repeated measures||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate||0.574|-0.037|
71816775|NCT00308737|143136065|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6475|||||TWO_SIDED|95.0|0.3432|1.2219|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.2219|0.3432|
71816776|NCT00308737|143136066|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7504|||||TWO_SIDED|95.0|0.251|2.2431|||Regression, Logistic|||Logistic regression excluding non-diabetics||2.2431|0.2510|
71816777|NCT00308737|143136067|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8953|||||TWO_SIDED|95.0|0.6703|1.1958|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.1958|0.6703|
71816778|NCT00308737|143136068|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.8509|||||TWO_SIDED|95.0|0.6722|1.077|||Regression, Logistic|||Logistic regression excluding non-diabetics||1.0770|0.6722|
71816779|NCT00308737|143136070|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|||Two sample t-test||||0.112
71816780|NCT00308737|143136071|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis tested was that the difference in incidence of a decrease of ≥ 15% in FEV1 between the treatment groups not be greater than 5% for TI when compared with the usual care treatment group. Assuming an incidence rate of 15% for FEV1 and a noninferiority criterion of a 5% difference in incidence between the treatment groups, approximately 625 subjects per group were required for 80% power and an alpha of 5% (1 tailed).|Odds Ratio (OR)|-2.4767|||||TWO_SIDED|95.0|-4.5578|-0.3956|||Regression, Logistic|||Logistic regression excluding non-diabetics||-0.3956|-4.5578|
71899620|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.27||||0.12|TWO_SIDED|95.0|0.94|1.72||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pills are more effective than condoms||1.72|0.94|0.12
71899621|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.0001|TWO_SIDED|95.0|1.94|3.62||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are more effective than pills||3.62|1.94|<0.0001
71899622|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - depo is more effective than condoms||2.44|1.29|0.0004
71899623|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0002|TWO_SIDED|95.0|1.36|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are an option for nulliparous young women||2.71|1.36|0.0002
71816781|NCT02224482|143136072|SUPERIORITY|||||||0.9634|||||||Mixed Models Analysis|||||||.9634
71816782|NCT02224482|143136073|SUPERIORITY|||||||0.5214|||||||Mixed Models Analysis|||||||.5214
71679318|NCT00174967|142876770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher's exact test. Adjustment for multiple comparisons was made using Hochberg's procedure.|Fisher Exact|||||||<0.001
71679319|NCT00174967|142876771|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816783|NCT02224482|143136074|SUPERIORITY|||||||0.4875|||||||Mixed Models Analysis|||||||.4875
71816784|NCT02224482|143136075|SUPERIORITY|||||||0.7938|||||||Mixed Models Analysis|||||||.7938
71816785|NCT02224482|143136076|SUPERIORITY|||||||0.6765|||||||Mixed Models Analysis|||||||.6765
71816786|NCT02224482|143136077|SUPERIORITY|||||||0.7061|||||||Mixed Models Analysis|||||||.7061
71816787|NCT02224482|143136078|SUPERIORITY|||||||0.7593|||||||Mixed Models Analysis|||||||.7593
71816788|NCT01225822|143136080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
71849008|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71899624|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.86||||0.001|TWO_SIDED|95.0|1.28|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Methods causing periods to stop are safe.||2.71|1.28|0.001
71899625|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.15||||0.36|TWO_SIDED|95.0|0.85|1.57||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - LARC can be removed early||1.57|0.85|0.36
71899626|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|2.76|||<|0.0001|TWO_SIDED|95.0|1.72|4.41||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - Copper IUD can act as EC||4.41|1.72|<0.0001
71899627|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|0.77||||0.49|TWO_SIDED|95.0|0.36|1.63||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - After sex, there is something you can do to prevent pregnancy||1.63|0.36|0.49
71679320|NCT00174967|142876771|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816789|NCT01225822|143136080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
71816790|NCT01225822|143136080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
71816791|NCT01225822|143136080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
71849009|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849010|NCT00824850|143211879|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849011|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|9.0|||||TWO_SIDED|95.0|-5.6|25.5||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||25.5|-5.6|
71849012|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849013|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
71849014|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|5.7|||||TWO_SIDED|95.0|-4.2|19.2||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||19.2|-4.2|
71849015|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
71849016|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849017|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849018|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.9|14.9||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||14.9|-6.9|
71849019|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|6.9|||||TWO_SIDED|95.0|-7.4|23.4||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||23.4|-7.4|
71849020|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849021|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71679321|NCT00174967|142876771|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816792|NCT01225822|143136080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
71816793|NCT01225822|143136080|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
71816794|NCT01225822|143136081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.577|0.244|<0.0001
71816795|NCT01225822|143136081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..||0.778|0.344|0.0015
71816796|NCT01225822|143136081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.||1.473|0.599|0.7856
71816797|NCT01225822|143136081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.727|0.302|0.0007
71816798|NCT01225822|143136081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||0.98|0.427|0.0401
71679322|NCT00174967|142876772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816799|NCT01225822|143136081|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.||1.817|0.859|0.2446
71816800|NCT01225822|143136082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.334||||0.0373||95.0|0.199|0.938|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.938|0.199|0.0373
71816801|NCT01225822|143136082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.837||||0.6659||95.0|0.374|1.875|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.875|0.374|0.6659
71679323|NCT00174967|142876772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816802|NCT01225822|143136082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.1882||95.0|0.183|1.397|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.397|0.183|0.1882
71816803|NCT01225822|143136082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.5566||95.0|0.39|1.66|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.66|0.39|0.5566
71816804|NCT01225822|143136082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.674||||0.3253||95.0|0.307|1.48|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.48|0.307|0.3253
71849022|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71816805|NCT01225822|143136082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0114||95.0|0.097|0.744|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.744|0.097|0.0114
71816806|NCT01225822|143136083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.332||||0.036||95.0|0.118|0.931|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||0.931|0.118|0.036
71816807|NCT01225822|143136083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.687||||0.3884||95.0|0.293|1.611|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.||1.611|0.293|0.3884
71816808|NCT01225822|143136083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.616||||0.3674||95.0|0.215|1.766|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.||1.766|0.215|0.3674
71816809|NCT01225822|143136083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.809||||0.5663||95.0|0.393|1.668|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.668|0.393|0.5663
71816810|NCT01225822|143136083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.1678||95.0|0.242|1.28|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||1.28|0.242|0.1678
71816811|NCT01225822|143136083|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.269||||0.0113||95.0|0.097|0.743|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.||0.743|0.097|0.0113
71816812|NCT01225822|143136084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.818||||0.0077||95.0|2.077|120.474|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||120.474|2.077|0.0077
71899628|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|0.73||||0.31|TWO_SIDED|95.0|0.39|1.34||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - EC can prevent pregnancy after sex||1.34|0.39|0.31
71899629|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.33||||0.08|TWO_SIDED|95.0|0.96|1.84||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pill does not affect fertility||1.84|0.96|0.08
71679324|NCT00174967|142876772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816813|NCT01225822|143136084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.907||||0.0062||95.0|2.229|128.238|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint||128.238|2.229|0.0062
71816814|NCT01225822|143136084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.7192||95.0|0.567|2.276|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as for primary endpoint||2.276|0.567|0.7192
71816815|NCT01225822|143136084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.121||||0.0472||95.0|0.015|0.974|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||0.974|0.015|0.0472
71816816|NCT01225822|143136084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.049||||0.1043||95.0|0.862|4.868|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.868|0.862|0.1043
71816817|NCT01225822|143136084|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.917||||0.1448||95.0|0.799|4.597|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint||4.597|0.799|0.1448
71816818|NCT01225822|143136086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.871||||0.0063|TWO_SIDED|95.0|2.221|128.142|||Regression, Logistic|||||128.142|2.221|0.0063
71849023|NCT00824850|143211880|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849024|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
71849025|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849026|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849027|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849028|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849029|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
71816819|NCT01225822|143136086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.338||||0.0025|TWO_SIDED|95.0|2.983|167.268|||Regression, Logistic|||||167.268|2.983|0.0025
71816820|NCT01225822|143136086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.919||||0.7973|TWO_SIDED|95.0|0.483|1.75|||Regression, Logistic|||||1.750|0.483|0.7973
71816821|NCT01225822|143136086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.068||||0.0097|TWO_SIDED|95.0|0.009|0.522|||Regression, Logistic|||||0.522|0.009|0.0097
71816822|NCT01225822|143136086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.522||||0.2375|TWO_SIDED|95.0|0.758|3.058|||Regression, Logistic|||||3.058|0.758|0.2375
71816823|NCT01225822|143136086|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7104|TWO_SIDED|95.0|0.55|2.403|||Regression, Logistic|||||2.403|0.550|0.7104
71816824|NCT04078035|143136091|SUPERIORITY||Slope|-0.00015|STANDARD_ERROR_OF_MEAN|0.00088||0.86|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.86
71816825|NCT04078035|143136092|SUPERIORITY||Slope|0.00022|STANDARD_ERROR_OF_MEAN|0.00067||0.74|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results present the condition (stress/control) by time interactions.||||0.74
71849030|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849031|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-6.7|15.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.3|-6.7|
71849032|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71816826|NCT04078035|143136093|SUPERIORITY||Slope|-0.0012|STANDARD_ERROR_OF_MEAN|0.0019||0.52|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.52
71899630|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.65||||0.002|TWO_SIDED|95.0|1.2|2.26||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.||Comparison of correct knowledge - patch does not affect fertility|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|2.26|1.2|0.002
71899631|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.23|2.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - ring does not affect fertility||2.35|1.23|0.002
71899632|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|0.94||||0.77|TWO_SIDED|95.0|0.62|1.43||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Depo does affect fertility||1.43|0.62|0.77
71679325|NCT00174967|142876773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71899633|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.61||||0.002|TWO_SIDED|95.0|1.19|2.17||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Hormonal IUD does not affect fertility||2.17|1.19|0.002
71899634|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.56||||0.004|TWO_SIDED|95.0|1.15|2.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Non-hormonal IUD does not affect fertility||2.1|1.15|0.004
71816827|NCT04078035|143136094|SUPERIORITY|Results present the condition (stress/control) by time\^2 interactions.|Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||||||<.001
71899635|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|1.54||||0.005|TWO_SIDED|95.0|1.14|2.07||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Implant does not affect fertility||2.07|1.14|0.005
71899636|NCT02078713|143321933|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.75|3.49||P-value calculated in multiply imputed dataset.|Regression, Logistic||OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer.|Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)||3.49|1.75|<0.0001
71899637|NCT02078713|143321934|SUPERIORITY||Odds Ratio (OR)|1.19||||0.25|TWO_SIDED|95.0|0.88|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at baseline||1.61|0.88|0.25
71899638|NCT02078713|143321934|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5|TWO_SIDED|95.0|0.66|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at 4 months post-enrollment||1.22|0.66|0.5
71899639|NCT02078713|143321934|SUPERIORITY||Odds Ratio (OR)|0.83||||0.23|TWO_SIDED|95.0|0.6|1.13||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.||1.13|0.60|0.23
71899640|NCT02078713|143321935|SUPERIORITY||Odds Ratio (OR)|0.91||||0.55|TWO_SIDED|95.0|0.66|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.25|0.66|0.55
71816828|NCT04078035|143136095|SUPERIORITY||Slope|0.0021|STANDARD_ERROR_OF_MEAN|0.00027|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 66.4, p \< .001.||Results-interaction between time2 and condition||||<.001
71899641|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|1.22||||0.13|TWO_SIDED|95.0|0.92|1.6||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.||1.6|0.92|0.13
71899642|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.99||||0.92|TWO_SIDED|95.0|0.75|1.3||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.||1.3|0.75|0.92
71899643|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.85||||0.17|TWO_SIDED|95.0|0.67|1.07||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating of implant||1.07|0.67|0.17
71899644|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.71||||0.009|TWO_SIDED|95.0|0.54|0.92||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.||0.92|0.54|0.009
71899645|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.86||||0.26|TWO_SIDED|95.0|0.65|1.12||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.||1.12|0.65|0.26
71816829|NCT04078035|143136096|SUPERIORITY||Slope|0.0013|STANDARD_ERROR_OF_MEAN|0.0002|<|0.001|TWO_SIDED||||||Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 77.2, p \< .001.||Results-interaction between time\^2 and condition||||<.001
71816830|NCT04078035|143136097|SUPERIORITY||Slope|0.0037|STANDARD_ERROR_OF_MEAN|0.0013||0.005|TWO_SIDED||||||Mixed Models Analysis|||Results below present the condition (stress/control) by time interactions.||||0.005
71816831|NCT04078035|143136098|SUPERIORITY||Slope|-0.0071|STANDARD_ERROR_OF_MEAN|0.074||0.92|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.92
71816832|NCT04078035|143136099|SUPERIORITY||Slope|-0.85|STANDARD_ERROR_OF_MEAN|0.41||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
71816833|NCT04078035|143136100|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.0033||0.002|TWO_SIDED|||||Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.|Mixed Models Analysis|Likelihood ratio test showed better fit if quadratic for time included χ2 (2) = 15.64, p \< .001.||Results-interaction between time\^2 and condition||||0.002
71816834|NCT04078035|143136101|SUPERIORITY||Slope|0.014|STANDARD_ERROR_OF_MEAN|0.0053||0.008|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results \_condition (stress/control) by time interactions.||||0.008
71849033|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.9|||||TWO_SIDED|95.0|-15.0|17.6||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.6|-15.0|
71816835|NCT04078035|143136102|SUPERIORITY||Slope|-0.0003|STANDARD_ERROR_OF_MEAN|0.0014||0.83|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.83
71816836|NCT04078035|143136103|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0033||0.03|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.03
71816837|NCT04078035|143136104|SUPERIORITY||Slope|0.00075|STANDARD_ERROR_OF_MEAN|0.00012||0.51|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.51
71816838|NCT04078035|143136105|SUPERIORITY||Slope|-0.0053|STANDARD_ERROR_OF_MEAN|0.0026||0.04|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.04
71816839|NCT04078035|143136106|SUPERIORITY||Slope|0.0018|STANDARD_ERROR_OF_MEAN|0.0027||0.49|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.49
71849034|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849035|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849036|NCT00824850|143211881|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
71849037|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
71849038|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
71849039|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849040|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
71849041|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849042|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|-2.8|||||TWO_SIDED|95.0|-16.8|10.1||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-16.8|
71679326|NCT00174967|142876773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816840|NCT04078035|143136107|SUPERIORITY||Slope|0.013|STANDARD_ERROR_OF_MEAN|0.0044||0.002|TWO_SIDED||||||Mixed Models Analysis|Subject, day (nested within subject), and time as random effects and condition (stress/control) as fixed effects.||Results below present the condition (stress/control) by time interactions.||||0.002
71849043|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
71849044|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|2.9|||||TWO_SIDED|95.0|-7.1|15.0||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.0|-7.1|
71849045|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
71816841|NCT01407354|143136155|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Chi-squared, Corrected|||||||0.05
71899646|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.85||||0.23|TWO_SIDED|95.0|0.64|1.11||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.||1.11|0.64|0.23
71899647|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.92||||0.55|TWO_SIDED|95.0|0.69|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.||1.22|0.69|0.55
71816842|NCT01407354|143136155|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|threshold p value for statistical significance=0.05||||||0.024
71816843|NCT03757234|143136198|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-2.6|||||TWO_SIDED|95.0|-12.4|6.9|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||6.9|-12.4|
71816844|NCT03757234|143136198|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-9.9|||||TWO_SIDED|95.0|-34.8|5.3|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||5.3|-34.8|
71816845|NCT03757234|143136198|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.0|||||TWO_SIDED|95.0|-30.6|8.2|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||8.2|-30.6|
71816846|NCT03757234|143136198|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment Difference|0.9|||||TWO_SIDED|95.0|-22.4|11.8|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||11.8|-22.4|
71816847|NCT03757234|143136199|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-5.4|||||TWO_SIDED|95.0|-23.6|12.7|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||12.7|-23.6|
71679327|NCT00174967|142876773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816848|NCT03757234|143136199|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-47.7|||||TWO_SIDED|95.0|-71.3|-6.0|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-6.0|-71.3|
71816849|NCT03757234|143136199|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-10.7|||||TWO_SIDED|95.0|-40.8|15.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||15.1|-40.8|
71816850|NCT03757234|143136199|NON_INFERIORITY|Non-inferiority margin for comparison of the doses was set at 10%.|Treatment difference|-36.5|||||TWO_SIDED|95.0|-62.6|-1.1|||||Point estimate and exact 95% confidence intervals for difference from levofloxacin (omadacycline minus levofloxacin) in clinical success rate was estimated.|||-1.1|-62.6|
71816851|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.05|TWO_SIDED|95.0|0.8|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for used (injected/snorted/smoked) heroin in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|0.80|0.05
71816852|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.01|TWO_SIDED|95.0|1.12|2.76|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for having Used (injected/snorted/smoked) powder cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.76|1.12|0.01
71816853|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.05|TWO_SIDED|95.0|1.0|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected and/or snorted) crack cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||2.44|1.00|0.05
71816854|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.03|TWO_SIDED|95.0|0.35|0.98|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected/snorted/smoked) methamphetamine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.98|0.35|0.03
71816855|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||<|0.01|TWO_SIDED|95.0|1.11|3.59|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for poly-substance use in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.59|1.11|<0.01
71899648|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.97||||0.84|TWO_SIDED|95.0|0.76|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.||1.25|0.76|0.84
71679328|NCT00174967|142876774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679329|NCT00174967|142876774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679330|NCT00174967|142876774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679331|NCT00174967|142876775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816856|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.87|||<|0.01|TWO_SIDED|95.0|3.84|12.28|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for Heavy drinking (\>14 and \>21 drinks/week for women and men respectively) in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||12.28|3.84|<0.01
71816857|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||<|0.01|TWO_SIDED|95.0|2.02|6.5|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Drank until blacked out in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||6.50|2.02|<0.01
71816858|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.04|TWO_SIDED|95.0|0.33|0.93|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Injected daily, past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||0.93|0.33|0.04
71899649|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.81||||0.07|TWO_SIDED|95.0|0.64|1.02||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.||1.02|0.64|0.07
71899650|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.59||||0.002|TWO_SIDED|95.0|0.42|0.82||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.||0.82|0.42|0.002
71679332|NCT00174967|142876775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71816859|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16|||<|0.01|TWO_SIDED|95.0|1.37|3.4|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Median number of injected partners \>= 5 in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.||3.40|1.37|<0.01
71679333|NCT00174967|142876775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679334|NCT00174967|142876776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679335|NCT00174967|142876776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679336|NCT00174967|142876776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg's procedure.|t-test, 2 sided|||||||<0.001
71679337|NCT02031640|142876777|SUPERIORITY||Least Square Mean (LSM) Difference|0.034||||0.272|TWO_SIDED|95.0|-0.027|0.095|||ANCOVA|||||0.095|-0.027|0.272
71679338|NCT02031640|142876777|SUPERIORITY||LSM Difference|0.045||||0.1415|TWO_SIDED|95.0|-0.015|0.106|||ANCOVA|||||0.106|-0.015|0.1415
71679339|NCT02031640|142876777|SUPERIORITY||LSM Difference|-0.015||||0.6356|TWO_SIDED|95.0|-0.075|0.046|||ANCOVA|||||0.046|-0.075|0.6356
71679340|NCT02031640|142876777|SUPERIORITY||LSM Difference|0.04||||0.1932|TWO_SIDED|95.0|-0.02|0.1|||ANCOVA|||||0.1|-0.02|0.1932
71679341|NCT02031640|142876778|OTHER|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction.|LSM Difference|10.616||||0.0036|TWO_SIDED|95.0|3.489|17.744|||Mixed Model for repeated measures|||||17.744|3.489|0.0036
71679342|NCT02031640|142876778|SUPERIORITY||LSM Difference|8.419||||0.0204|TWO_SIDED|95.0|1.309|15.53|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||15.53|1.309|0.0204
71679343|NCT02031640|142876778|SUPERIORITY||LSM Difference|6.004||||0.0984|TWO_SIDED|95.0|-1.121|13.129|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||13.129|-1.121|0.0984
71679344|NCT02031640|142876778|SUPERIORITY||LSM Difference|12.512||||0.0006|TWO_SIDED|95.0|5.435|19.589|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction||19.589|5.435|0.0006
71679345|NCT02031640|142876779|SUPERIORITY||LSM Difference|9.147||||0.0139|TWO_SIDED|95.0|1.866|16.429|||Mixed Model for repeated measures|||||16.429|1.866|0.0139
71816860|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.19|TWO_SIDED|95.0|0.81|1.97|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days||1.97|0.81|0.19
71816861|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.01|TWO_SIDED|95.0|1.01|2.55|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Injected with someone else's used needle/syringe in the past 30 days|Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 days||2.55|1.01|<0.01
71899651|NCT02078713|143321936|SUPERIORITY||Odds Ratio (OR)|0.58||||0.005|TWO_SIDED|95.0|0.4|0.85||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.||0.85|0.4|0.005
71679346|NCT02031640|142876779|SUPERIORITY||LSM Difference|9.17||||0.0133|TWO_SIDED|95.0|1.914|16.425|||Mixed Model for repeated measures|||||16.425|1.914|0.0133
71679347|NCT02031640|142876779|SUPERIORITY||LSM Difference|4.088||||0.2704|TWO_SIDED|95.0|-3.191|11.367|||Mixed Model for repeated measures|||||11.367|-3.191|0.2704
71679348|NCT02031640|142876779|SUPERIORITY||LSM Difference|10.301||||0.0053|TWO_SIDED|95.0|3.073|17.53|||Mixed Model for repeated measures|||||17.53|3.073|0.0053
71679349|NCT02031640|142876780|SUPERIORITY||LSM Difference|-0.703|||<|0.0001|TWO_SIDED|95.0|-1.044|-0.363|||Mixed Model for repeated measures|||||-0.363|-1.044|<0.0001
71679350|NCT02031640|142876780|SUPERIORITY||LSM Difference|-0.691|||<|0.0001|TWO_SIDED|95.0|-1.029|-0.352|||Mixed Model for repeated measures|||||-0.352|-1.029|<0.0001
71679351|NCT02031640|142876780|SUPERIORITY||LSM Difference|-0.651||||0.0002|TWO_SIDED|95.0|-0.994|-0.309|||Mixed Model for repeated measures|||||-0.309|-0.994|0.0002
71679352|NCT02031640|142876780|SUPERIORITY||LSM difference|-0.801|||<|0.0001|TWO_SIDED|95.0|-1.138|-0.464|||Mixed Model for repeated measures|||||-0.464|-1.138|<0.0001
71679353|NCT02031640|142876781|SUPERIORITY||Mean Difference (Final Values)|-0.149||||0.0119|TWO_SIDED|95.0|-0.265|-0.033|||Mixed Models Analysis|||||-0.033|-0.265|0.0119
71679354|NCT02031640|142876781|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.0854|TWO_SIDED|95.0|-0.217|0.014|||Mixed Models Analysis|||||0.014|-0.217|0.0854
71679355|NCT02031640|142876781|SUPERIORITY||Mean Difference (Final Values)|-0.189||||0.0016|TWO_SIDED|95.0|-0.306|-0.072|||Mixed Models Analysis|||||-0.072|-0.306|0.0016
71679356|NCT02031640|142876781|SUPERIORITY||Mean Difference (Final Values)|-0.216||||0.0003|TWO_SIDED|95.0|-0.332|-0.101|||Mixed Models Analysis|||||-0.101|-0.332|0.0003
71679357|NCT05356533|142876784|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71679358|NCT05356533|142876784|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||ANOVA|||||||>.05
71816862|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.07|||<|0.01|TWO_SIDED|95.0|1.79|5.27|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days||5.27|1.79|<0.01
71679359|NCT05356533|142876785|SUPERIORITY||Risk Ratio (RR)|1.08|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71679360|NCT05356533|142876786|SUPERIORITY||Risk Ratio (RR)|0.81|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71679361|NCT05356533|142876787|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71679362|NCT05356533|142876788|SUPERIORITY||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71679363|NCT05356533|142876789|SUPERIORITY||Risk Ratio (RR)|1.11|||>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>.05
71816863|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.01|TWO_SIDED|95.0|1.34|3.32|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Shared cooker/spook to prepare drugs in the past 30 days|Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviors||3.32|1.34|<0.01
71679364|NCT03085238|142876795|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.1309|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||0.1309
71816864|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87|||<|0.01|TWO_SIDED|95.0|1.19|2.95|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having used Backloaded Syringe in the past 30 days|Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviors||2.95|1.19|<0.01
71816865|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.13|TWO_SIDED|95.0|0.83|2.1|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|"Adjusted odds for travel in prior 3 months as a risk factor for having done Someone's rinse in the past 30 days"|Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 days||2.10|0.83|0.13
71816866|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.01|TWO_SIDED|95.0|1.4|3.49|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for Median number of sexual partners \>=2 in the past 30 days|Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||3.49|1.40|<0.01
71816867|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.86|TWO_SIDED|95.0|0.45|1.85|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Traded sex for money or drugs in the past 30 days|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 days||1.85|0.45|0.86
71816868|NCT00244374|143136221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.59|2.02|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for condom use \>90% (if sexually active)|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 days||2.02|0.59|0.73
71816869|NCT01486758|143136229|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
71816870|NCT01486758|143136233|SUPERIORITY_OR_OTHER|||||||0.048|||||||Log Rank|||||||0.048
71816871|NCT02608489|143136259|SUPERIORITY_OR_OTHER|||||||0.221|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.221
71816872|NCT02608489|143136259|SUPERIORITY_OR_OTHER|||||||0.015|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.015
71816873|NCT02608489|143136260|SUPERIORITY_OR_OTHER|||||||0.256|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.256
71816874|NCT02608489|143136260|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.||||0.025
71816875|NCT02608489|143136261|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.080
71816876|NCT02608489|143136261|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.||||0.021
71816877|NCT02608489|143136262|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||<0.001
71816878|NCT02608489|143136262|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||<0.001
71816879|NCT02608489|143136262|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||<0.001
71816880|NCT02608489|143136263|SUPERIORITY_OR_OTHER|||||||0.045|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.045
71899652|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.55||||0.27|TWO_SIDED|95.0|0.71|3.42||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of hormonal IUD||3.42|0.71|0.27
71899653|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.65||||0.18|TWO_SIDED|95.0|0.8|3.4||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of non-hormonal IUD||3.40|0.80|0.18
71899654|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.29||||0.5|TWO_SIDED|95.0|0.62|2.69||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of implant||2.69|0.62|0.5
71899655|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.7||||0.32|TWO_SIDED|95.0|0.59|4.89||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of the patch||4.89|0.59|0.32
71899656|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.38||||0.37|TWO_SIDED|95.0|0.68|2.81||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of ring||2.81|0.68|0.37
71679365|NCT03085238|142876796|NON_INFERIORITY|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.0181|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence \<= 90% - Non-inferiority margin (25%)||||.0181
71679366|NCT05896527|142876805|SUPERIORITY||Odds Ratio (OR)|0.46||||0.4839|TWO_SIDED|95.0|0.07|2.37|||Fisher Exact||DC-806 200 mg BID compared to Placebo|||2.37|0.07|0.4839
71816881|NCT02608489|143136264|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.001
71899657|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of male sterilization (vasectomy)||3.73|0.60|0.39
71899658|NCT02078713|143321937|SUPERIORITY||Odds Ratio (OR)|1.49||||0.39|TWO_SIDED|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of female sterilization||3.73|0.6|0.39
71899659|NCT02078713|143321938|SUPERIORITY||Odds Ratio (OR)|1.27||||0.18|TWO_SIDED|95.0|0.9|1.81||P-value calculated from multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|"The odds ratio represents the odds of the intervention group rating their appointment as much better, in the numerator, over the odds of the control group giving this rating in the denominator."|Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.||1.81|0.90|0.18
71899660|NCT02078713|143321939|SUPERIORITY||Mean Difference (Final Values)|11.81|||<|0.001|TWO_SIDED|95.0|8.54|18.66||P-value calculated in multiple imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||18.66|8.54|<0.001
71679367|NCT05896527|142876805|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4111|TWO_SIDED|95.0|0.51|6.49|||Fisher Exact||DC-806 400 mg BID compared to Placebo|||6.49|0.51|0.4111
71679368|NCT05896527|142876805|SUPERIORITY||Odds Ratio (OR)|1.3||||0.7744|TWO_SIDED|95.0|0.36|4.99|||Fisher Exact||DC-806 600 mg QD compared to Placebo|||4.99|0.36|0.7744
71679369|NCT05896527|142876805|SUPERIORITY||Odds Ratio (OR)|3.59||||0.0164|TWO_SIDED|95.0|1.15|12.37|||Fisher Exact||DC-806 800 mg BID compared to Placebo|||12.37|1.15|0.0164
71816882|NCT02608489|143136264|SUPERIORITY_OR_OTHER|||||||0.002|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4||||0.002
71899661|NCT02078713|143321940|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.63|TWO_SIDED|95.0|-3.19|5.29||P-value calculated in multiply imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.|||5.29|-3.19|0.63
71816883|NCT02608489|143136264|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12||||0.034
71816884|NCT02608489|143136265|SUPERIORITY_OR_OTHER|||||||0.151|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.||||0.151
71679370|NCT01279070|142876807|SUPERIORITY_OR_OTHER||Effect size|0.43|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML.An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 16 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
71816885|NCT01411501|143136267|SUPERIORITY_OR_OTHER|||||||0.352|TWO_SIDED||||||ANCOVA|||||||0.352
71816886|NCT01411501|143136268|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANCOVA|||||||0.968
71679371|NCT01279070|142876808|SUPERIORITY_OR_OTHER||Effect Size|0.42|||<|0.05|TWO_SIDED|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood(REML).An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 40 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.||0.7|0.1|<0.05
71816887|NCT01411501|143136269|SUPERIORITY_OR_OTHER|||||||0.841|TWO_SIDED||||||Kruskal-Wallis|||||||0.841
71816888|NCT01411501|143136270|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
71816889|NCT01411501|143136271|SUPERIORITY_OR_OTHER|||||||0.198|TWO_SIDED||||||ANCOVA|||||||0.198
71816890|NCT01411501|143136272|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Kruskal-Wallis|||||||0.035
71816891|NCT01703702|143136279|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.002|TWO_SIDED|95.0|1.22|2.38|||Chi-squared|||||2.38|1.22|0.002
71816892|NCT01703702|143136280|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35||||0.568|TWO_SIDED|95.0|-1.54|0.84|||ANCOVA|Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.||||0.84|-1.54|0.568
71816893|NCT01703702|143136281|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|43.9|||<|0.001|TWO_SIDED|95.0|20.0|96.12|||Chi-squared|||||96.12|20|<0.001
71816894|NCT01703702|143136282|SUPERIORITY_OR_OTHER||LS Mean Difference|20.69|||<|0.001|TWO_SIDED|95.0|18.95|22.43|||ANCOVA|Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)||Comparison of change in diagnostic confidence at follow-up (3 months)||22.43|18.95|<0.001
71816895|NCT01703702|143136283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.144|TWO_SIDED|95.0|0.92|1.78|||Chi-squared|||||1.78|0.92|0.144
71816896|NCT01703702|143136284|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.925|TWO_SIDED|95.0|-3.2|3.53|||ANCOVA|Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).||||3.53|-3.20|0.925
71816897|NCT01703702|143136285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.7|1.54|||Chi-squared|||Major Diagnostic Tests||1.54|0.70|0.857
71849046|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|1.2|||||TWO_SIDED|95.0|-14.8|18.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||18.2|-14.8|
71849047|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71816898|NCT01703702|143136285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.36|2.81|||Chi-squared|||Alzheimer's/Cognitive Medication||2.81|1.36|<0.001
71899662|NCT02078713|143321941|SUPERIORITY||Observed coefficient|-3.97|STANDARD_ERROR_OF_MEAN|3.34||0.24|TWO_SIDED|95.0|-10.62|2.68|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error.|Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and site||2.68|-10.62|0.24
71816899|NCT01703702|143136285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.063|TWO_SIDED|95.0|0.97|2.64|||Chi-squared|||Neuropsychological Tests||2.64|0.97|0.063
71816900|NCT01703702|143136285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.741|TWO_SIDED|95.0|0.69|1.7|||Chi-squared|||Physician Follow-up for Re-evaluation||1.70|0.69|0.741
71816901|NCT01703702|143136285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.046|TWO_SIDED|95.0|1.01|2.08|||Chi-squared|||Specialist Referral||2.08|1.01|0.046
71816902|NCT01200030|143136298|OTHER|The effect size of the intervention was adopted from a mate-analysis . The showed an average effect size of 0.59 in improving the motor control of limbs in people with stroke. A sample size for each group was set at 11 . Presuming that there would be a drop-out rate of 10% during the course of study, an extra 1 subject was recruited in each group. the sample size was 36. The statistical significance was set at 5% (alpha \< 0.05) with power equal to 80%|||||<|0.001||||||Post-hoc pairwise comparisons have been conducted. Please refer to subsequent data analyses.|Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.||||<0.001
71816903|NCT01200030|143136298|OTHER|||||||1||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.||||1.00
71816904|NCT01200030|143136298|OTHER|||||||0.002||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.002
71816905|NCT01200030|143136298|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."||||0.003
71816906|NCT01200030|143136299|OTHER|||||||0.055|||||||Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.||||0.055
71849048|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-6.8|15.8||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||15.8|-6.8|
71816907|NCT00136812|143136300|OTHER|We used all available observations in a GEE analysis and did not impute missing data or drop observations.|Odds Ratio (OR)|3.15||||0.018|TWO_SIDED|95.0|1.22|8.14||P-value of \<0.05 is considered statistically significant.|generalized estimating equation model|||To test the primary hypothesis, we ran a generalized estimating equation model with logit link function (PROC GENMOD in SAS version 9.2), to examine abstinence versus smoking status at the 3- through 18-month follow-ups by condition.||8.14|1.22|0.018
71816908|NCT04542226|143136305|OTHER||||||<|1e-07||||||the a priori threshold for statistical significance p\<0.05|Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test for repeated measures was used to compare with baseline.||||||<0.0000001
71816909|NCT03560258|143136328|SUPERIORITY|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.137
71816910|NCT03560258|143136328|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.014
71816911|NCT03560258|143136328|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 or CD8 T cell response from week 0 to week 26.||||0.100
71816912|NCT03560258|143136330|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
71816913|NCT03560258|143136330|SUPERIORITY|||||||0.222|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||0.222
71816914|NCT03560258|143136330|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD4 T cell response at week 26 from baseline.||||1.00
71816915|NCT03560258|143136331|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.678
71816916|NCT03560258|143136331|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.037
71816917|NCT03560258|143136331|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in additional number of CEs with a CD8 T cell response from week 0 to week 26.||||0.100
71816918|NCT03560258|143136332|SUPERIORITY|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.303
71816919|NCT03560258|143136332|SUPERIORITY|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.457
71816920|NCT03560258|143136332|SUPERIORITY|||||||0.678|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: Full-length Gag DNA and Arm C: Placebo in change in the magnitude of CD4 T cell responses from week 0 to week 26.||||0.678
71816921|NCT03560258|143136333|SUPERIORITY|||||||0.755|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: p24CE/full-length Gag DNA and Arm B: Full-length Gag DNA in change in the magnitude of CD8 T cell responses from week 0 to week 26.||||0.755
71816922|NCT03560258|143136333|SUPERIORITY|||||||0.867|||||||Wilcoxon (Mann-Whitney)|||||||0.867
71816923|NCT03560258|143136333|SUPERIORITY|||||||0.521|||||||Wilcoxon (Mann-Whitney)|||||||0.521
71816924|NCT02091739|143136351|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.031|=|0.004|TWO_SIDED|95.0|-0.15|0.03|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units versus (v) Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.03|-0.15|= 0.004
71899663|NCT02078713|143321941|SUPERIORITY||Observed coefficient|-1.52|STANDARD_ERROR_OF_MEAN|1.91||0.36|TWO_SIDED|95.0|-4.76|1.72|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error|Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.||1.72|-4.76|0.36
71899664|NCT02078713|143321941|SUPERIORITY||Slope|-1.64|STANDARD_ERROR_OF_MEAN|1.34||0.28|TWO_SIDED|95.0|-4.61|1.34|||Regression, Linear||Tool group compared to control group (ref). Bootstrapping used for standard error.|Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.||1.34|-4.61|0.28
71899665|NCT02078713|143321942|SUPERIORITY||Odds Ratio (OR)|1.06||||0.78|TWO_SIDED|95.0|0.69|1.65||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|||1.65|0.69|0.78
71899666|NCT02078713|143321943|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.35|0.66|0.75
71816925|NCT02091739|143136351|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.03|=|0.542|TWO_SIDED|95.0|-0.08|0.04|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.04|-0.08|= 0.542
71899667|NCT02078713|143321943|SUPERIORITY||Odds Ratio (OR)|1.07||||0.71|TWO_SIDED|95.0|0.75|1.53||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.53|0.75|0.71
71899668|NCT02078713|143321944|SUPERIORITY||Odds Ratio (OR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.34||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||1.34|0.66|0.75
71816926|NCT02091739|143136352|SUPERIORITY||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|0.183|=|0.002|TWO_SIDED|95.0|0.22|0.94|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.94|0.22|= 0.002
71849049|NCT00824850|143211882|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||7.6|-13.9|
71849050|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|29.47|||||TWO_SIDED|95.0|17.61|49.33|||||Confidence intervals (CI) for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||49.33|17.61|
71849051|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.34|||||TWO_SIDED|95.0|8.49|15.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.13|8.49|
71849052|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.58|||||TWO_SIDED|95.0|4.06|7.67|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.67|4.06|
71899669|NCT02078713|143321944|SUPERIORITY||Odds Ratio (OR)|1.17||||0.37|TWO_SIDED|95.0|0.83|1.64||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||1.64|0.83|0.37
71899670|NCT02078713|143321945|SUPERIORITY||Odds Ratio (OR)|1.27||||0.63|TWO_SIDED|95.0|0.48|3.37||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment||3.37|0.48|0.63
71899671|NCT02078713|143321945|SUPERIORITY||Odds Ratio (OR)|1.83||||0.11|TWO_SIDED|95.0|0.88|3.8||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment||3.80|0.88|0.11
71899672|NCT00696657|143321954|SUPERIORITY||Estimated treatment differences|-1.19|||<|0.0001|TWO_SIDED|95.0|-1.58|-0.8|||ANOVA|Confidence interval (CIs) for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Placebo. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.80|-1.58|<0.0001
71899673|NCT00696657|143321954|SUPERIORITY||Estimated treatment differences|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.57|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.57|-1.33|<0.0001
71899674|NCT00696657|143321954|SUPERIORITY||Estimated treatment differences|-0.97|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.59|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.8 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.59|-1.35|<0.0001
71899675|NCT00696657|143321954|SUPERIORITY||Estimated treatment differences|-0.61||||0.0002|TWO_SIDED|95.0|-0.98|-0.23|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.4 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.23|-0.98|0.0002
71849053|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|71.09|||||TWO_SIDED|95.0|40.74|124.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||124.08|40.74|
71849054|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.91|||||TWO_SIDED|95.0|4.92|12.73|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.73|4.92|
71849055|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.56|||||TWO_SIDED|95.0|2.87|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|2.87|
71849056|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.85|||||TWO_SIDED|95.0|4.51|10.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.42|4.51|
71849057|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.98|17.64|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||17.64|6.98|
71849058|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.68|||||TWO_SIDED|95.0|1.37|2.07|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.07|1.37|
71899676|NCT00696657|143321954|SUPERIORITY||Estimated treatment differences|-0.41||||0.0324|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.02|-0.79|0.0324
71849059|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.1|||||TWO_SIDED|95.0|1.52|2.9|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.90|1.52|
71849060|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.7|||||TWO_SIDED|95.0|4.77|12.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.42|4.77|
71849061|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.2|||||TWO_SIDED|95.0|4.95|10.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.48|4.95|
71849062|NCT00824850|143211883|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.02|||||TWO_SIDED|95.0|2.23|4.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.10|2.23|
71849063|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|19.68|||||TWO_SIDED|95.0|9.99|38.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||38.77|9.99|
71849064|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.7|||||TWO_SIDED|95.0|3.9|8.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||8.33|3.90|
71899677|NCT00696657|143321954|SUPERIORITY||Estimated treatment differences|-0.09||||0.9772|TWO_SIDED|95.0|-0.46|0.28|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||"The comparison sequence should be read as Semaglutide 0.1 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.28|-0.46|0.9772
71849065|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.78|||||TWO_SIDED|95.0|2.16|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.16|
71849066|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.46|||||TWO_SIDED|95.0|13.17|41.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.79|13.17|
71899678|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.35|||||TWO_SIDED|95.0|-0.64|-0.06|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.06|-0.64|
71899679|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.11|||||TWO_SIDED|95.0|-0.39|0.18|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.18|-0.39|
71679372|NCT01279070|142876809|SUPERIORITY_OR_OTHER||Effect Size|0.33|||<|0.05|TWO_SIDED|95.0|0.06|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.06|<0.05
71899680|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.13|||||TWO_SIDED|95.0|-0.42|0.16|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.16|-0.42|
71899681|NCT00696657|143321954|OTHER||Estimated treatment differences|0.24|||||TWO_SIDED|95.0|-0.05|0.52|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.52|-0.05|
71899682|NCT00696657|143321954|OTHER||Estimated treatment differences|0.44|||||TWO_SIDED|95.0|0.15|0.73|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.73|0.15|
71899683|NCT00696657|143321954|OTHER||Estimated treatment differences|0.75|||||TWO_SIDED|95.0|0.48|1.03|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.8 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||1.03|0.48|
71899684|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.84|||||TWO_SIDED|95.0|-1.12|-0.56|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.8 mg - Placebo . The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.56|-1.12|
71816927|NCT02091739|143136352|SUPERIORITY||LS mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.181|=|0.055|TWO_SIDED|95.0|-0.01|0.71|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~1. IncobotulinumtoxinA 100 units v Placebo~2. IncobotulinumtoxinA 75 units v Placebo"||0.71|-0.01|= 0.055
71816928|NCT00192023|143136355|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to Week 8 Endpoint. Change = Endpoint minus baseline. Model: Change to Week 8=score at Week 8+treatment+site+treatment-by-site interaction. If treatment-by-site interaction isn't significant it will be removed from model.|ANCOVA|||Using an estimate of the common standard deviation of 13 points, the planned sample size will give about 80% power to detect a difference between the groups of 8 points on the SNAP-IV. The sample size was determined using a two-sided test with p=0.05, and assumes that up to 10% of patients will discontinue the study without providing post-baseline efficacy data in Study Period III.||||<0.001
71816929|NCT00192023|143136356|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
71849067|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|13.68|||||TWO_SIDED|95.0|8.94|20.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||20.92|8.94|
71849068|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.98|||||TWO_SIDED|95.0|6.21|12.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||12.97|6.21|
71679373|NCT01279070|142876810|SUPERIORITY_OR_OTHER||Effect Size|0.35|||<|0.05|TWO_SIDED|95.0|0.09|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.6|0.09|<0.05
71816930|NCT00192023|143136357|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.001
71816931|NCT00192023|143136358|SUPERIORITY_OR_OTHER|||||||0.836||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.836
71816932|NCT00192023|143136359|SUPERIORITY_OR_OTHER|||||||0.87||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.870
71816933|NCT00192023|143136360|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
71816934|NCT00192023|143136360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
71816935|NCT00192023|143136360|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.022
71816936|NCT00192023|143136360|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||<0.001
71816937|NCT00192023|143136361|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.071
71816938|NCT00192023|143136362|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.002
71849069|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|9.0|||||TWO_SIDED|95.0|5.91|13.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.72|5.91|
71849070|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.58|||||TWO_SIDED|95.0|5.36|10.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.72|5.36|
71849071|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.56|||||TWO_SIDED|95.0|1.3|1.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.86|1.30|
71849072|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.93|||||TWO_SIDED|95.0|1.43|2.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.60|1.43|
71849073|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.46|||||TWO_SIDED|95.0|3.09|6.45|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.45|3.09|
71816939|NCT00192023|143136362|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.113
71816940|NCT00192023|143136362|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.051
71849074|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.32|||||TWO_SIDED|95.0|3.65|7.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.75|3.65|
71849075|NCT00824850|143211884|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.27|||||TWO_SIDED|95.0|2.49|4.28|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.28|2.49|
71899685|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.51|||||TWO_SIDED|95.0|-0.8|-0.22|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 1.6 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.22|-0.80|
71816941|NCT00192023|143136362|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA|||||||0.061
71679374|NCT01279070|142876811|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
71679375|NCT01279070|142876812|SUPERIORITY_OR_OTHER||Effect Size|0.3|||<|0.05|TWO_SIDED|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups, standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR) assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.||0.7|0.01|<0.05
71679376|NCT05139303|142876818|OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71679377|NCT02045862|142876823|SUPERIORITY||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.69|-0.21||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.69|<0.001
71679378|NCT02045862|142876823|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.37|0.11||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.11|-0.37|0.002
71679379|NCT02045862|142876824|SUPERIORITY||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.77|-0.2||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.20|-0.77|<0.001
71679380|NCT02045862|142876824|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.15||0.004|TWO_SIDED|95.0|-0.71|-0.13||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.13|-0.71|0.004
71679381|NCT02045862|142876825|SUPERIORITY||Least Squares Mean Difference|15.84|STANDARD_ERROR_OF_MEAN|3.49|<|0.001|TWO_SIDED|95.0|8.99|22.69|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||22.69|8.99|<0.001
71679382|NCT02045862|142876825|SUPERIORITY||Least Squares Mean Difference|12.77|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|5.98|19.57|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||19.57|5.98|<0.001
71679383|NCT02045862|142876826|SUPERIORITY||Least Squares Mean Difference|-7.55|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-10.05|-5.05|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-5.05|-10.05|<0.001
71899686|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.27|||||TWO_SIDED|95.0|-0.56|0.02|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg (with titration) - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.02|-0.56|
71899687|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.29|||||TWO_SIDED|95.0|-0.58|0.01|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.8 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.01|-0.58|
71816942|NCT01003184|143136371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.6|||<|0.0001|TWO_SIDED|95.0|3.17|13.73|||Regression, Logistic|Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.||"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.~Sample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference."||13.73|3.17|<.0001
71816943|NCT01003184|143136372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.06|||<|0.0001|TWO_SIDED|95.0|3.64|13.7|||Regression, Logistic|Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.||||13.70|3.64|<.0001
71816944|NCT01003184|143136373|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.104||0.0001|TWO_SIDED|95.0|-0.62|-0.2|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-0.20|-0.62|0.0001
71816945|NCT01003184|143136374|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|0.488|<|0.0001|TWO_SIDED|95.0|-4.63|-2.71|||Mixed Models Analysis|||Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-2.71|-4.63|<.0001
71816946|NCT01003184|143136375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.0497|TWO_SIDED|95.0|1.0|3.18|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.18|1.00|0.0497
71816947|NCT01003184|143136376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.0074|TWO_SIDED|95.0|1.24|3.96|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||3.96|1.24|0.0074
71816948|NCT01003184|143136377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.89||||0.0002|TWO_SIDED|95.0|2.1|11.35|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.||11.35|2.10|0.0002
71849076|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|15.86|||||TWO_SIDED|95.0|9.16|27.46|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.46|9.16|
71849077|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|5.01|||||TWO_SIDED|95.0|3.5|7.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.16|3.50|
71849078|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.86|||||TWO_SIDED|95.0|2.93|5.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.09|2.93|
71849079|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.57|||||TWO_SIDED|95.0|11.11|27.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||27.79|11.11|
71849080|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.22|||||TWO_SIDED|95.0|2.86|6.23|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.23|2.86|
71899688|NCT00696657|143321954|OTHER||Estimated treatment differences|0.08|||||TWO_SIDED|95.0|-0.22|0.37|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.4 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.37|-0.22|
71899689|NCT00696657|143321954|OTHER||Estimated treatment differences|0.28|||||TWO_SIDED|95.0|-0.02|0.57|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.2 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.57|-0.02|
71899690|NCT00696657|143321954|OTHER||Estimated treatment differences|0.59|||||TWO_SIDED|95.0|0.31|0.88|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Semaglutide 0.1 mg - Liraglutide 1.2 mg. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||0.88|0.31|
71899691|NCT00696657|143321954|OTHER||Estimated treatment differences|-0.68|||||TWO_SIDED|95.0|-0.97|-0.4|||ANOVA|CIs for treatment differences versus liraglutide are not corrected for multiple testing.||"The comparison sequence should be read as Liraglutide 1.2 mg - Placebo. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate."||-0.40|-0.97|
71899692|NCT04688346|143322006|NON_INFERIORITY|t-test|Mean Difference (Final Values)|1.0||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71899693|NCT00059215|143322008|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||Fisher Exact|||||||0.933
71899694|NCT00059215|143322008|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Log Rank|||||||0.590
71899695|NCT00059215|143322009|SUPERIORITY_OR_OTHER|||||||0.945||95.0|||||Fisher Exact|||||||0.945
71899696|NCT00059215|143322009|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Log Rank|||||||0.260
71899697|NCT00059215|143322010|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71899698|NCT00059215|143322010|SUPERIORITY_OR_OTHER|||||||0.544||95.0|||||Log Rank|||||||0.544
71679384|NCT02045862|142876826|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-7.09|-2.12|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-2.12|-7.09|<0.001
71679385|NCT02045862|142876827|SUPERIORITY||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.28|0.82|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.82|0.28|<0.001
71849081|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.54|||||TWO_SIDED|95.0|1.78|3.62|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.62|1.78|
71899699|NCT00059215|143322011|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Fisher Exact|||||||0.370
71899700|NCT04985799|143322015|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|14.8||||0.04|TWO_SIDED|95.0|1.1|28.5|||Chi-squared|||||28.5|1.1|0.04
71899701|NCT04985799|143322016|NON_INFERIORITY|For the sample size, a total of 143 participants, or 72 participants per group was needed, based on a 90% effectiveness for both slings 14% non-inferiority margin, 80% power, alpha of 0.05 and a 20% dropout rate.|Risk Difference (RD)|7.4||||0.29|TWO_SIDED|95.0|-6.2|21.1|||Chi-squared|||||21.1|-6.2|0.29
71899702|NCT04985799|143322018|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71679386|NCT02045862|142876827|SUPERIORITY||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.32|0.86|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.86|0.32|<0.001
71849082|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.21|||||TWO_SIDED|95.0|2.86|6.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.19|2.86|
71899703|NCT04494633|143322019|SUPERIORITY|||||||0.482314|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t-test with 61 degrees of freedom.||||||0.482314
71899704|NCT04494633|143322020|SUPERIORITY|||||||0.876964|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, t test with 61 degrees of freedom.||||||.876964
71899705|NCT04494633|143322021|SUPERIORITY|||||||0.66602|||||||t-test, 2 sided|The change for each group was analyzed using a 2-tailed, unpaired, independent means, with 61 degrees of freedom.||||||.66602
71849083|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.23|||||TWO_SIDED|95.0|2.79|6.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||6.42|2.79|
71899706|NCT04494633|143322022|SUPERIORITY|||||||0.726421|||||||t-test, 2 sided|Two-tailed unpaired t test comparing change for control (Pre to 2 weeks later) to case (Pre- to 2 weeks post) with 61 degrees of freedom.||||||.726421
71899707|NCT04494633|143322023|SUPERIORITY|||||||0.908468|||||||t-test, 2 sided|The statistical test used was a 2 tailed, unpaired t test with 61 degrees of freedom.||||||0.908468
71899708|NCT04494633|143322024|SUPERIORITY|||||||0.468104|||||||t-test, 2 sided|The groups were compared using a two tailed unpaired t test with 61 degrees of freedom.||||||.468104
71899709|NCT01254604|143322028|NON_INFERIORITY_OR_EQUIVALENCE|The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.|Difference in Least Squares Means|-1.7|||||TWO_SIDED|95.0|-2.6|-0.7|||ANCOVA|Analysis model includes terms for treatment, baseline IOP and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Difference is tafluprost - timolol|The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost - timolol) was ≤1.5 mmHg.||-0.7|-2.6|
71899710|NCT01254604|143322029|SUPERIORITY_OR_OTHER||Difference in percentage|19.5|||||TWO_SIDED|95.0|5.7|33.4|||Stratified Miettinen and Nurminen method|Participants were stratified by baseline IOP (\<26 mmHg or ≥26 mmHg at 0800 hours) and ocular diagnosis (open-angle glaucoma or ocular hypertension)|Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) - percentage (timolol)|||33.4|5.7|
71899711|NCT01254604|143322030|SUPERIORITY_OR_OTHER||Difference in percentage|-3.9|||||TWO_SIDED|95.0|-17.3|9.4|||Miettinen and Nurminen||Between-group difference in percentage of participants with an AE = percentage (tafluprost) - percentage (timolol)|||9.4|-17.3|
71899712|NCT01254604|143322031|SUPERIORITY_OR_OTHER||Difference in percentage|1.1|||||TWO_SIDED|95.0|-3.5|5.7|||Miettinen and Nurminen||Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) - percentage (timolol)|||5.7|-3.5|
71899713|NCT03074162|143322032|EQUIVALENCE|The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|45.54|STANDARD_ERROR_OF_MEAN|35.99|||TWO_SIDED|90.0|40.11|51.7|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||51.70|40.11|
71899714|NCT03074162|143322032|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|85.56|STANDARD_ERROR_OF_MEAN|42.05|||TWO_SIDED|90.0|74.11|98.77|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||98.77|74.11|
71816949|NCT01003184|143136378|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.257||0.6993|TWO_SIDED|95.0|-0.41|0.61|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.61|-0.41|0.6993
71899715|NCT03074162|143322033|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|49.6|STANDARD_ERROR_OF_MEAN|38.13|||TWO_SIDED|90.0|43.39|56.71|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/R) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.|||56.71|43.39|
71899716|NCT03074162|143322033|EQUIVALENCE|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|83.57|STANDARD_ERROR_OF_MEAN|72.45|||TWO_SIDED|90.0|66.33|105.31|||ANOVA|Only the data for the comparison under investigation were included in the statistical analysis.|gMean Ratio=(B/A) \*100. Standard Error of the mean is actually intra-individual geometric coefficient of variation|||105.31|66.33|
71899717|NCT01993329|143322037|SUPERIORITY||Geometric means ratio|1.108||||0.616|TWO_SIDED|95.0|0.734|1.673|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.673|0.734|0.616
71899718|NCT01993329|143322037|SUPERIORITY||Geometric means ratio|1.016||||0.939|TWO_SIDED|95.0|0.673|1.534|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.534|0.673|0.939
71899719|NCT01993329|143322037|SUPERIORITY||Geometric means ratio|0.917||||0.671|TWO_SIDED|95.0|0.607|1.384|||ANOVA||Analysis was based on an ANOVA model with log (base 2) PC20 methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||1.384|0.607|0.671
71899720|NCT01993329|143322038|SUPERIORITY||Mean Difference (Final Values)|-0.111||||0.066|TWO_SIDED|95.0|-0.23|0.008|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect.|||0.008|-0.230|0.066
71899721|NCT01993329|143322038|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.843|TWO_SIDED|95.0|-0.131|0.107|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.107|-0.131|0.843
71899722|NCT01993329|143322038|SUPERIORITY||Mean Difference (Final Values)|-0.099||||0.098|TWO_SIDED|95.0|-0.218|0.02|||ANOVA||Analysis is based on an ANOVA model with minimum highest FEV1 after methacholine challenge at each period as dependent variable, treatment and period as fixed effects and participant as random effect|||0.020|-0.218|0.098
71899723|NCT03041116|143322039|SUPERIORITY||Difference in LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.8|=|0.9115|TWO_SIDED|95.0|-1.69|1.51||p-value was derived from test of contrast between treatment effects using LSM estimate, adjusted for baseline score and age group from Type III analysis. The test of contrast at Week 24 was considered the primary comparison.|Mixed Models Analysis|||||1.51|-1.69|=0.9115
71899724|NCT03041116|143322041|SUPERIORITY||Difference in LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.1421|TWO_SIDED|95.0|-0.7|4.78||p-value was derived from the test of contrast between treatment effects using the LSM estimate, adjusted for baseline score and age group from the Type III analysis. The test of contrast at week 24 was considered the primary comparison.|Mixed Models Analysis|||||4.78|-0.7|=0.1421
71899725|NCT00931892|143322071|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.670
71899726|NCT00931892|143322072|OTHER|||||||0.409|||||||t-test, 2 sided|||||||0.409
71899727|NCT00931892|143322073|OTHER|||||||0.387|||||||t-test, 2 sided|||||||0.387
71899728|NCT00931892|143322073|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
71899729|NCT00931892|143322074|SUPERIORITY|||||||0.01|||||||ANOVA|||P Value for IgA anti-tTG||||0.010
71899730|NCT00931892|143322074|SUPERIORITY|||||||0.036|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.036
71899731|NCT00931892|143322074|SUPERIORITY|||||||0.013|||||||ANOVA|||P Value for IgA anti-tTG||||0.013
71899732|NCT00931892|143322074|SUPERIORITY|||||||0.006|||||||ANOVA|||P Value for IgA/IgG anti-DGP||||0.006
71899733|NCT00931892|143322076|OTHER|||||||0.05|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) score for Day 3 of Gluten Challenge||||0.05
71899734|NCT00931892|143322076|OTHER|||||||0.02|||||||t-test, 2 sided|||P Value for Celiac Symptom Index (CSI) Score from baseline to Day 14||||0.020
71899735|NCT00931892|143322076|SUPERIORITY|||||||0.06|||||||ANOVA|||P Value for Celiac Symptom Index (CSI)score between high gluten group and low gluten group across study||||0.060
71899736|NCT00931892|143322078|OTHER|||||||0.01|||||||t-test, 2 sided|||P Value for the Gastrointestinal Symptom Rating Scale (GSRS) on Day 3 of the Gluten Challenge||||0.01
71899737|NCT00931892|143322078|OTHER|||||||0.012|||||||t-test, 2 sided|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) from baseline to Day 14 of Gluten Challenge||||0.012
71899738|NCT00931892|143322078|SUPERIORITY|||||||0.09|||||||ANOVA|||P Value for Gastrointestinal Symptom Rating Scale (GSRS) between high gluten group and low gluten group across study||||0.090
71899739|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.047||||||"P- value for social function"|Wilcoxon signed-rank test|||||||0.047
71899740|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.688||||||"P- value of  symptom/problem list "|Wilcoxon signed-rank test|||||||0.688
71899741|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.772||||||"P- value of  effects of kidney disease "|Wilcoxon signed-rank test|||||||0.772
71899742|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.301||||||"P-value of  burden of kidney disease "|Wilcoxon signed-rank test|||||||0.301
71899743|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.25||||||"P-value of  work status "|Wilcoxon signed-rank test|||||||0.250
71899744|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.895||||||"P-value of  cognitive function "|Wilcoxon signed-rank test|||||||0.895
71899745|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.281||||||"P-value of  quality of social interaction "|Wilcoxon signed-rank test|||||||0.281
71899746|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  sleep "|Wilcoxon signed-rank test|||||||1.00
71899747|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  social support "|Wilcoxon signed-rank test|||||||1.00
71899748|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.943||||||"P-value of  dialysis staff encouragement "|Wilcoxon signed-rank test|||||||0.943
71899749|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||1||||||"P-value of  overall health "|Wilcoxon signed-rank test|||||||1.00
71899750|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.09||||||"P-value of  patient satisfaction "|Wilcoxon signed-rank test|||||||0.090
71899751|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.391||||||"P-value of  physical functioning "|Wilcoxon signed-rank test|||||||0.391
71899752|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.438||||||"P-value of  role-physical "|Wilcoxon signed-rank test|||||||0.438
71899753|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.424||||||"P-value of  pain "|Wilcoxon signed-rank test|||||||0.424
71899754|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.169||||||"P-value of  general health "|Wilcoxon signed-rank test|||||||0.169
71899755|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.858||||||"P-value of  emotional well-being "|Wilcoxon signed-rank test|||||||0.858
71899756|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.156||||||"P-value of  role-emotional "|Wilcoxon signed-rank test|||||||0.156
71899757|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.084||||||"P-value of  energy/fatigue "|Wilcoxon signed-rank test|||||||0.084
71899758|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.583||||||"P-value of  SF-12 physical composite "|Wilcoxon signed-rank test|||||||0.583
71899759|NCT01876732|143322080|SUPERIORITY_OR_OTHER|||||||0.358||||||"p-value of  SF-12 mental composite "|Wilcoxon signed-rank test|||||||0.358
71899760|NCT02531373|143322085|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-13.5|3.1||||||||3.1|-13.5|
71899761|NCT02531373|143322085|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-16.3|1.2||||||||1.2|-16.3|
71899762|NCT02531373|143322085|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-3.9|||||TWO_SIDED|95.0|-13.3|3.2||||||||3.2|-13.3|
71899763|NCT02531373|143322085|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-1.9|||||TWO_SIDED|95.0|-10.2|5.1||||||||5.1|-10.2|
71899764|NCT02531373|143322086|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
71899765|NCT02531373|143322086|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.2||||||||7.2|-6.9|
71899766|NCT02531373|143322086|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|7.1||||||||7.1|-6.9|
71899767|NCT02531373|143322086|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-6.9|6.9||||||||6.9|-6.9|
71899768|NCT02531373|143322087|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|20.3||||0.029|TWO_SIDED|95.0|2.1|37.3|||Miettinen and Nurminen method|||||37.3|2.1|0.029
71899769|NCT02531373|143322087|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|22.3||||0.016|TWO_SIDED|95.0|4.3|39.1|||Miettinen and Nurminen method|||||39.1|4.3|0.016
71899770|NCT02531373|143322087|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|1.1||||0.908|TWO_SIDED|95.0|-17.7|19.9|||Miettinen and Nurminen method|||||19.9|-17.7|0.908
71899771|NCT02531373|143322087|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|23.1||||0.011|TWO_SIDED|95.0|5.4|39.6|||Miettinen and Nurminen method|||||39.6|5.4|0.011
71899772|NCT02531373|143322088|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-0.5||||0.943|TWO_SIDED|95.0|-14.0|12.9|||Miettinen and Nurminen method|||||12.9|-14.0|0.943
71899773|NCT02531373|143322088|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|-2.5||||0.711|TWO_SIDED|95.0|-16.4|11.2|||Miettinen and Nurminen method|||||11.2|-16.4|0.711
71899774|NCT02531373|143322088|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|3.7||||0.529|TWO_SIDED|95.0|-8.7|16.4|||Miettinen and Nurminen method|||||16.4|-8.7|0.529
71899775|NCT02531373|143322088|EQUIVALENCE|Miettinen and Nurminen method|Risk Difference (RD)|5.8||||0.298|TWO_SIDED|95.0|-5.8|18.2|||Miettinen and Nurminen method|||||18.2|-5.8|0.298
71899776|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.61|1.1||||||Serotype 1||1.10|0.61|
71899777|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.77|||||TWO_SIDED|95.0|1.33|2.35||||||Serotype 3||2.35|1.33|
71899778|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.91|1.81||||||Serotype 4||1.81|0.91|
71899779|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.59|1.51||||||Serotype 5||1.51|0.59|
71899780|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.5||||||95.0|0.29|0.86||||||Serotype 6A||0.86|0.29|
71899781|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.58|2.1||||||Serotype 6B||2.10|0.58|
71899782|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.55|1.03||||||Serotype 7F||1.03|0.55|
71899783|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.74|1.75||||||Serotype 9V||1.75|0.74|
71899784|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.58|1.27||||||Serotype 14||1.27|0.58|
71899785|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.63||||||95.0|0.43|0.92||||||Serotype 18C||0.92|0.43|
71899786|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.64|1.26||||||Serotype 19A||1.26|0.64|
71899787|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.62|1.11||||||Serotype 19F||1.11|0.62|
71899788|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|81.47|||||TWO_SIDED|95.0|60.51|109.68||||||Serotype 22F (non-Prevnar serotype)||109.68|60.51|
71899789|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.56|1.47||||||Serotype 23F||1.47|0.56|
71899790|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|22.23|||||TWO_SIDED|95.0|11.77|41.97||||||Serotype 33F (non-Prevnar serotype)||41.97|11.77|
71899791|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.68|1.23||||||Serotype 1||1.23|0.68|
71899792|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|2.11|||||TWO_SIDED|95.0|1.6|2.8||||||Serotype 3||2.80|1.60|
71899793|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.15|||||TWO_SIDED|95.0|0.82|1.62||||||Serotype 4||1.62|0.82|
71899794|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.53|1.31||||||Serotype 5||1.31|0.53|
71899795|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.54|||||TWO_SIDED|95.0|0.31|0.92||||||Serotype 6A||0.92|0.31|
71899796|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.42|1.5||||||Serotype 6B||1.50|0.42|
71899797|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.71|1.31||||||Serotype 7F||1.31|0.71|
71899798|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.64|1.49||||||Serotype 9V||1.49|0.64|
71899799|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.63|1.37||||||Serotype 14||1.37|0.63|
71899800|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.55|1.16||||||Serotype 18C||1.16|0.55|
71899801|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.63|1.22||||||Serotype 19A||1.22|0.63|
71899802|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.81|1.44||||||Serotype 19F||1.44|0.81|
71899803|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|89.87|||||TWO_SIDED|95.0|67.02|120.51||||||Serotype 22F (non-Prevnar serotype)||120.51|67.02|
71899804|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.61|1.57||||||Serotype 23F||1.57|0.61|
71899805|NCT02531373|143322089|EQUIVALENCE|2-sample t-test|Risk Ratio (RR)|18.38|||||TWO_SIDED|95.0|9.82|34.41||||||Serotype 33F (non-Prevnar serotype)||34.41|9.82|
71679387|NCT02045862|142876829|SUPERIORITY||Rate Ratio|0.67|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.54|0.84|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.84|0.54|<0.001
71899806|NCT02795988|143322111|SUPERIORITY||Cox proportional hazard regression model|0.603||||0.078|TWO_SIDED|80.0|0.38|0.957||1-sided p-value was calculated from Log-rank test stratified by factor tumor stage which used for randomization at screening.|Log Rank|||||0.957|0.380|0.078
71899807|NCT04705597|143322134|SUPERIORITY||Odds Ratio (OR)|1.366||||0.3312|TWO_SIDED|95.0|0.728|2.562|||Regression, Logistic|||||2.562|0.728|0.3312
71899808|NCT04705597|143322136|SUPERIORITY||Odds Ratio (OR)|0.574||||0.4561|TWO_SIDED|95.0|0.133|2.475|||Regression, Logistic|||Day 14||2.475|0.133|0.4561
71899809|NCT04705597|143322136|SUPERIORITY||Odds Ratio (OR)|0.521||||0.1559|TWO_SIDED|95.0|0.212|1.282|||Regression, Logistic|||Day 28||1.282|0.212|0.1559
71899810|NCT04705597|143322136|SUPERIORITY||Odds Ratio (OR)|0.498||||0.1293|TWO_SIDED|95.0|0.203|1.226|||Regression, Logistic|||Day 57||1.226|0.203|0.1293
71899811|NCT04705597|143322137|SUPERIORITY|||||||0.2687|||||||Log Rank|||Statistical analysis was only performed for Day 28. This is timeframe used for the primary endpoint||||0.2687
71899812|NCT04705597|143322138|SUPERIORITY|||||||0.3977|||||||Log Rank|||||||0.3977
71899813|NCT04705597|143322139|SUPERIORITY|||||||0.2229|||||||Log Rank|||||||0.2229
71899814|NCT04705597|143322140|SUPERIORITY||Odds Ratio (OR)|1.388||||0.2941|TWO_SIDED|95.0|0.752|2.561|||Regression, Logistic|||||2.561|0.752|0.2941
71899815|NCT04705597|143322141|SUPERIORITY|||||||0.3325|||||||Log Rank|||||||0.3325
71899816|NCT04705597|143322142|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.0254|TWO_SIDED|95.0|0.08|1.2||Change at Day 14|ANCOVA|||||1.2|0.08|0.0254
71899817|NCT04705597|143322142|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.1109|TWO_SIDED|95.0|-0.12|1.18|||ANCOVA|||Change at Day 28||1.18|-0.12|0.1109
71899818|NCT04705597|143322142|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.864|TWO_SIDED|95.0|-0.1|0.12|||ANCOVA|||Change at Day 57||0.12|-0.10|0.8640
71899819|NCT04705597|143322143|SUPERIORITY||Odds Ratio (OR)|2.046||||0.0919|TWO_SIDED|95.0|0.89|4.706|||Regression, Logistic|||||4.706|0.89|0.0919
71899820|NCT04705597|143322144|SUPERIORITY||Mean Difference (Final Values)|3.83||||0.749|TWO_SIDED|95.0|-0.42|8.08|||ANCOVA|||||8.08|-0.42|0.749
71899821|NCT04705597|143322145|SUPERIORITY||Mean Difference (Final Values)|3.69||||0.1769|TWO_SIDED|95.0|-1.75|9.13|||ANCOVA|||||9.13|-1.75|0.1769
71899822|NCT04705597|143322146|SUPERIORITY||Odds Ratio (OR)|0.54||||0.2621|TWO_SIDED|95.0|0.184|1.586|||Regression, Logistic|||||1.586|0.184|0.2621
71899823|NCT04705597|143322147|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.2265|TWO_SIDED|95.0|-1.76|7.37|||ANCOVA|||||7.37|-1.76|0.2265
71899824|NCT04705597|143322148|SUPERIORITY||Odds Ratio (OR)|1.223||||0.5497|TWO_SIDED|95.0|0.633|2.364|||Regression, Logistic|||||2.364|0.633|0.5497
71899825|NCT04705597|143322149|SUPERIORITY||Mean Difference (Final Values)|4.89||||0.1172|TWO_SIDED|95.0|-1.27|11.05|||ANCOVA|||||11.05|-1.27|0.1172
71899826|NCT04705597|143322150|SUPERIORITY||Odds Ratio (OR)|0.914||||0.853|TWO_SIDED|95.0|0.353|2.368|||Regression, Logistic|||||2.368|0.353|0.853
71899827|NCT04705597|143322151|SUPERIORITY||Mean Difference (Final Values)|3.16||||0.1991|TWO_SIDED|95.0|-1.86|8.18|||ANCOVA|||||8.18|-1.86|0.1991
71899828|NCT04705597|143322152|SUPERIORITY||Odds Ratio (OR)|4.103||||0.0166|TWO_SIDED|95.0|1.293|13.027|||Regression, Logistic|||||13.027|1.293|0.0166
71899829|NCT04705597|143322153|SUPERIORITY||Mean Difference (Final Values)|4.56||||0.1297|TWO_SIDED|95.0|-1.51|10.64|||ANCOVA|||||10.64|-1.51|0.1297
71899830|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.1916|TWO_SIDED|95.0|-0.35|0.07|||ANCOVA|||Baseline||0.07|-0.35|0.1916
71899831|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.1097|TWO_SIDED|95.0|-0.44|0.05|||ANCOVA|||Treatment Day 2||0.05|-0.44|0.1097
71899832|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0276|TWO_SIDED|95.0|-0.63|-0.04|||ANCOVA|||Treatment Day 3||-0.04|-0.63|0.0276
71899833|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0463|TWO_SIDED|95.0|-0.71|-0.01|||ANCOVA|||Treatment Day 4||-0.01|-0.71|0.0463
71899834|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.0969|TWO_SIDED|95.0|-0.71|0.06|||ANCOVA|||Treatment Day 5||0.06|-0.71|0.0969
71899835|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.4367|TWO_SIDED|95.0|-0.57|0.25|||ANCOVA|||Treatment Day 6||0.25|-0.57|0.4367
71899836|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6685|TWO_SIDED|95.0|-0.54|0.35|||ANCOVA|||Treatment Day 7||0.35|-0.54|0.6685
71899837|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.2287|TWO_SIDED|95.0|-0.73|0.18|||ANCOVA|||Treatment Day 8||0.18|-0.73|0.2287
71679388|NCT02045862|142876829|SUPERIORITY||Rate Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.12||0.029|TWO_SIDED|95.0|0.61|0.97|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.||0.97|0.61|0.029
71849084|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.63|||||TWO_SIDED|95.0|1.3|2.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.05|1.30|
71816950|NCT01003184|143136379|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.72|STANDARD_ERROR_OF_MEAN|1.853||0.0116|TWO_SIDED|95.0|-8.37|-1.07|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||-1.07|-8.37|0.0116
71816951|NCT01003184|143136380|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|1.179||0.7034|TWO_SIDED|95.0|-2.77|1.88|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.||1.88|-2.77|0.7034
71816952|NCT01003184|143136381|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.09||0.1061|TWO_SIDED|95.0|-0.32|0.03|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.03|-0.32|0.1061
71816953|NCT01003184|143136382|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.4638|TWO_SIDED|95.0|-0.05|0.02|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.02|-0.05|0.4638
71816954|NCT01003184|143136383|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.107||0.4967|TWO_SIDED|95.0|-0.14|0.28|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.||0.28|-0.14|0.4967
71816955|NCT01003184|143136384|SUPERIORITY_OR_OTHER||Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.322||0.3247|TWO_SIDED|95.0|0.19|1.72|||Poisson regression|||The number of episodes by patient were compared between treatment groups using a poisson model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.||1.72|0.19|0.3247
71816956|NCT03662997|143136385|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular arm, Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
71816957|NCT03662997|143136385|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.56||||||Five-layer vs Hydrocellular arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.56
71849085|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.67|||||TWO_SIDED|95.0|1.3|2.14|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.14|1.30|
71816958|NCT03662997|143136385|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer arm; Weeks 1 \& 3|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.010
71816959|NCT03662997|143136385|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.25||||||Five-layer vs Hydropolymer arm; Weeks 2 \& 4|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.25
71816960|NCT03662997|143136386|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.046||||||Five-layer vs Hydrocellular; End of Weeks 1 and 3.|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||0.046
71849086|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.6|||||TWO_SIDED|95.0|2.39|5.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.42|2.39|
71816961|NCT03662997|143136386|SUPERIORITY|In this superiority study the primary efficacy analysis included constructing a two sided 5% significance level, using Fisher's non-parametric permutation test for ordered categorical variables and dichotomous variables for the differences. Numbers, percentages improved, not changed, worsened were analyzed with Mantel-Haenszel Exact Chi square over the course of 4 weeks in a 2x2 weeks treatment period inferiority will be established.||||||0.01||||||Five-layer vs Hydropolymer; End of Weeks 1 \& 3|Chi-squared, Corrected||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups|||0.010
71816962|NCT03662997|143136394|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during first the week of treatment.|||||<|0.05||||||Five-layer vs Hydrocellular arm, first week of treatment|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
71816963|NCT03662997|143136394|SUPERIORITY|This secondary outcome measure was not planned for at the initiation of the study. Compliance rates were calculated by combining the number incidences that dressings were worn for the full 7 days and when the dressings do not have strike-through during the first week of treatment.|||||<|0.05||||||Five-layer vs Hydropolymer, first week of treatment.|Chi-squared||||All data presented on the performance of the dressings reflect the FAS populations for the study comparison groups.|||<0.05
71816964|NCT02563522|143136397|OTHER||Mean Difference (Final Values)|18.7||||0.3455|TWO_SIDED|95.0|-12.37|45.81|||Fisher Exact|No imputation was performed for subjects with missing response data||The statistical hypotheses were H0: Pt = Pc versus Ha: Pt ≠ Pc, where Pt and Pc are the proportions of subjects with a confirmed target would closure by the 4-month follow-up for Active (Engensis) and Control (Placebo) groups, respectively. The hypothesis testing was a two-sided alpha of 0.05||45.81|-12.37|0.3455
71816965|NCT02912468|143136423|SUPERIORITY||LS mean difference|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.07|-0.71|||ANCOVA|||Data were analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.71|-1.07|<0.0001
71816966|NCT02912468|143136424|SUPERIORITY||LS mean difference|-2.06|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.69|||ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-1.69|-2.43|<0.0001
71816967|NCT02912468|143136425|SUPERIORITY|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 24 SNOT-22.|LS mean difference|-7.44|||<|0.0001|TWO_SIDED|95.0|-8.35|-6.53||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-6.53|-8.35|<.0001
71816968|NCT02912468|143136426|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.61|||<|0.0001|TWO_SIDED|95.0|-3.04|-2.17||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-2.17|-3.04|<.0001
71816969|NCT02912468|143136427|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.56|||<|0.0001|TWO_SIDED|95.0|8.79|12.34||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||12.34|8.79|<.0001
71816970|NCT02912468|143136428|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.31|-0.93||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-0.93|-1.31|<.0001
71816971|NCT02912468|143136429|SUPERIORITY|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.12|||<|0.0001|TWO_SIDED|95.0|-25.17|-17.06||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.||-17.06|-25.17|<.0001
71816972|NCT00406419|143136491|SUPERIORITY||Weighted difference|18.5|||<|0.0001|TWO_SIDED|95.0|11.0|25.9|||Cochran-Mantel-Haenszel|||||25.9|11|< 0.0001
71816973|NCT00406419|143136491|SUPERIORITY||Weighted difference|21.4|||<|0.0001|TWO_SIDED|95.0|14.1|28.8|||Cochran-Mantel-Haenszel|||||28.8|14.1|< 0.0001
71816974|NCT00406419|143136492|SUPERIORITY||Weighted difference|30.8|||<|0.0001|TWO_SIDED|95.0|23.7|37.9|||Cochran-Mantel-Haenszel|||||37.9|23.7|< 0.0001
71899838|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.1061|TWO_SIDED|95.0|-0.96|0.09|||ANCOVA|||Treatment Day 9||0.09|-0.96|0.1061
71899839|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.0415|TWO_SIDED|95.0|-1.06|-0.02|||ANCOVA|||Treatment Day 10||-0.02|-1.06|0.0415
71679389|NCT02045862|142876830|SUPERIORITY||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-4.76|-1.49||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.49|-4.76|<0.001
71679390|NCT02045862|142876830|SUPERIORITY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.84|<|0.001|TWO_SIDED|95.0|-2.57|0.72||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.72|-2.57|<0.001
71679391|NCT02045862|142876831|SUPERIORITY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.26|2.01|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate||2.01|1.26|<0.001
71679392|NCT02045862|142876831|SUPERIORITY||Odds Ratio (OR)|1.38||||0.009|TWO_SIDED|95.0|1.08|1.75|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.||1.75|1.08|0.009
71679393|NCT02045862|142876832|SUPERIORITY||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.05|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||2.05|1.26|<0.001
71679394|NCT02045862|142876832|SUPERIORITY||Odds Ratio (OR)|1.45||||0.002|TWO_SIDED|95.0|1.14|1.85|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.||1.85|1.14|0.002
71679395|NCT02045862|142876833|SUPERIORITY||Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.65|-0.21||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.21|-0.65|<0.001
71899840|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.44||||0.1236|TWO_SIDED|95.0|-1.0|0.12|||ANCOVA|||Treatment Day 11||0.12|-1.00|0.1236
71688680|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.16|0.28|||t-test, 2 sided|||FEV1 Day 8 (-0.25 hrs post-dose)||0.28|0.16|<0.0001
71849087|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.41|||||TWO_SIDED|95.0|2.42|4.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||4.82|2.42|
71849088|NCT00824850|143211885|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.9|||||TWO_SIDED|95.0|1.6|2.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.26|1.60|
71849089|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.36|||||TWO_SIDED|95.0|4.5|15.56|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.56|4.50|
71849090|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.37|||||TWO_SIDED|95.0|1.78|3.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.16|1.78|
71899841|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0097|TWO_SIDED|95.0|-1.23|-0.18|||ANCOVA|||Treatment Day 12||-0.18|-1.23|0.0097
71899842|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.57||||0.0157|TWO_SIDED|95.0|-1.02|-0.11|||ANCOVA|||Treatment Day 13||-0.11|-1.02|0.0157
71899843|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.84||||0.001|TWO_SIDED|95.0|-1.32|-0.36|||ANCOVA|||Treatment Day 14||-0.36|-1.32|0.0010
71899844|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.644|TWO_SIDED|95.0|-0.4|0.25|||ANCOVA|||Time of Discharge Visit||0.25|-0.40|0.6440
71849091|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.02|||||TWO_SIDED|95.0|1.63|2.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.49|1.63|
71899845|NCT04705597|143322154|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9869|TWO_SIDED|95.0|-0.6|0.59|||ANCOVA|||Follow up Day 28||0.59|-0.60|0.9869
71899846|NCT04705597|143322155|SUPERIORITY||Mean Difference (Final Values)|1.69||||0.2399|TWO_SIDED|95.0|-1.14|4.52|||ANCOVA|||||4.52|-1.14|0.2399
71899847|NCT04705597|143322156|SUPERIORITY||Odds Ratio (OR)|0.869||||0.8081|TWO_SIDED|95.0|0.28|2.695|||Regression, Logistic|||||2.695|0.28|0.8081
71899848|NCT04705597|143322157|SUPERIORITY||Odds Ratio (OR)|1.436||||0.3193|TWO_SIDED|95.0|0.704|2.929|||Regression, Logistic|||||2.929|0.704|0.3193
71899849|NCT03691623|143322158|SUPERIORITY||LS Mean Difference|-588.08|||<|0.001|TWO_SIDED|95.0|-719.8|-456.35|||ANCOVA|||||-456.35|-719.8|< 0.001
71899850|NCT03691623|143322158|SUPERIORITY||LS Mean Difference|-564.63|||<|0.001|TWO_SIDED|95.0|-689.23|-440.02|||ANCOVA|||||-440.02|-689.23|< 0.001
71899851|NCT03691623|143322158|SUPERIORITY||LS Mean Difference|-716.08|||<|0.001|TWO_SIDED|95.0|-879.92|-552.24|||ANCOVA|||||-552.24|-879.92|< 0.001
71899852|NCT03691623|143322158|SUPERIORITY||LS Mean Difference|-736.23|||<|0.001|TWO_SIDED|95.0|-916.36|-556.11|||ANCOVA|||||-556.11|-916.36|< 0.001
71899853|NCT03691623|143322159|SUPERIORITY||LS Mean Difference|-355.91|||<|0.001|TWO_SIDED|95.0|-506.12|-205.69|||ANCOVA|||||-205.69|-506.12|< 0.001
71899854|NCT03691623|143322159|SUPERIORITY||LS Mean Difference|-326.64|||<|0.001|TWO_SIDED|95.0|-469.68|-183.6|||ANCOVA|||||-183.6|-469.68|< 0.001
71899855|NCT03691623|143322159|SUPERIORITY||LS Mean Difference|-313.98|||=|0.001|TWO_SIDED|95.0|-494.27|-133.69|||ANCOVA|||||-133.69|-494.27|= 0.001
71899856|NCT03691623|143322159|SUPERIORITY||LS Mean Difference|-312.73|||=|0.003|TWO_SIDED|95.0|-508.05|-117.4|||ANCOVA|||||-117.4|-508.05|= 0.003
71899857|NCT03691623|143322160|SUPERIORITY||LS Mean Difference|-3.7|||<|0.001|TWO_SIDED|95.0|-5.3|-2.0|||ANCOVA|||||-2|-5.3|< 0.001
71899858|NCT03691623|143322160|SUPERIORITY||LS Mean Difference|-3.9|||<|0.001|TWO_SIDED|95.0|-5.5|-2.4|||ANCOVA|||||-2.4|-5.5|< 0.001
71899859|NCT03691623|143322160|SUPERIORITY||LS Mean Difference|-3.0|||=|0.002|TWO_SIDED|95.0|-4.9|-1.2|||ANCOVA|||||-1.2|-4.9|= 0.002
71899860|NCT03691623|143322160|SUPERIORITY||LS Mean Difference|-2.9|||=|0.006|TWO_SIDED|95.0|-4.9|-0.9|||ANCOVA|||||-0.9|-4.9|= 0.006
71849092|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|6.61|||||TWO_SIDED|95.0|4.31|10.15|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||10.15|4.31|
71899861|NCT03691623|143322162|SUPERIORITY||LS Mean Difference|-0.82|||=|0.199|TWO_SIDED|95.0|-2.09|0.44|||ANCOVA|||||0.44|-2.09|= 0.199
71899862|NCT03691623|143322162|SUPERIORITY||LS Mean Difference|0.22|||=|0.714|TWO_SIDED|95.0|-0.98|1.43|||ANCOVA|||||1.43|-0.98|= 0.714
71899863|NCT03691623|143322162|SUPERIORITY||LS Mean Difference|-0.19|||=|0.844|TWO_SIDED|95.0|-2.15|1.77|||ANCOVA|||||1.77|-2.15|= 0.844
71899864|NCT03691623|143322162|SUPERIORITY||LS Mean Difference|-1.34|||=|0.21|TWO_SIDED|95.0|-3.46|0.79|||ANCOVA|||||0.79|-3.46|= 0.21
71899865|NCT03691623|143322163|SUPERIORITY||LS Mean Difference|-1.01|||=|0.145|TWO_SIDED|95.0|-2.37|0.36|||ANCOVA|||||0.36|-2.37|= 0.145
71899866|NCT03691623|143322163|SUPERIORITY||LS Mean Difference|-0.65|||=|0.352|TWO_SIDED|95.0|-2.03|0.73|||ANCOVA|||||0.73|-2.03|= 0.352
71899867|NCT03691623|143322163|SUPERIORITY||LS Mean Difference|-2.85|||=|0.002|TWO_SIDED|95.0|-4.55|-1.15|||ANCOVA|||||-1.15|-4.55|= 0.002
71899868|NCT03691623|143322163|SUPERIORITY||LS Mean Difference|-3.4|||<|0.001|TWO_SIDED|95.0|-5.19|-1.61|||ANCOVA|||||-1.61|-5.19|< 0.001
71899869|NCT03691623|143322164|SUPERIORITY||LS Mean Difference|-24.081|||<|0.001|TWO_SIDED|95.0|-36.554|-11.607|||ANCOVA|||||-11.607|-36.554|< 0.001
71899870|NCT03691623|143322164|SUPERIORITY||LS Mean Difference|-25.954|||<|0.001|TWO_SIDED|95.0|-37.695|-14.213|||ANCOVA|||||-14.213|-37.695|< 0.001
71899871|NCT03691623|143322164|SUPERIORITY||LS Mean Difference|-18.13|||<|0.001|TWO_SIDED|95.0|-27.176|-9.083|||ANCOVA|||||-9.083|-27.176|< 0.001
71899872|NCT03691623|143322164|SUPERIORITY||LS Mean Difference|-19.329|||<|0.001|TWO_SIDED|95.0|-29.106|-9.552|||ANCOVA|||||-9.552|-29.106|< 0.001
71899873|NCT03691623|143322165|SUPERIORITY||LS Mean Difference|-2.1292|||<|0.001|TWO_SIDED|95.0|-2.8491|-1.4093|||ANCOVA|||||-1.4093|-2.8491|< 0.001
71899874|NCT03691623|143322165|SUPERIORITY||LS Mean Difference|-2.1129|||<|0.001|TWO_SIDED|95.0|-2.7938|-1.4319|||ANCOVA|||||-1.4319|-2.7938|< 0.001
71899875|NCT03691623|143322165|SUPERIORITY||LS Mean Difference|-3.2191|||<|0.001|TWO_SIDED|95.0|-4.1915|-2.2467|||ANCOVA|||||-2.2467|-4.1915|< 0.001
71899876|NCT03691623|143322165|SUPERIORITY||LS Mean Difference|-2.7831|||<|0.001|TWO_SIDED|95.0|-3.8522|-1.714|||ANCOVA|||||-1.714|-3.8522|< 0.001
71899877|NCT03691623|143322166|SUPERIORITY||LS Mean Difference|-2.01|||<|0.001|TWO_SIDED|95.0|-2.67|-1.35|||ANCOVA|||||-1.35|-2.67|< 0.001
71899878|NCT03691623|143322166|SUPERIORITY||LS Mean Difference|-1.78|||<|0.001|TWO_SIDED|95.0|-2.4|-1.16|||ANCOVA|||||-1.16|-2.4|< 0.001
71899879|NCT03691623|143322166|SUPERIORITY||LS Mean Difference|-1.98|||=|0.009|TWO_SIDED|95.0|-3.43|-0.54|||ANCOVA|||||-0.54|-3.43|= 0.009
71899880|NCT03691623|143322166|SUPERIORITY||LS Mean Difference|-2.41|||=|0.004|TWO_SIDED|95.0|-4.0|-0.82|||ANCOVA|||||-0.82|-4|= 0.004
71899881|NCT03691623|143322167|SUPERIORITY||LS Mean Difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.04|-1.17|||ANCOVA|||||-1.17|-3.04|< 0.001
71899882|NCT03691623|143322167|SUPERIORITY||LS Mean Difference|-2.0|||<|0.001|TWO_SIDED|95.0|-2.89|-1.11|||ANCOVA|||||-1.11|-2.89|< 0.001
71899883|NCT03691623|143322167|SUPERIORITY||LS Mean Difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.06|-0.89|||ANCOVA|||||-0.89|-3.06|< 0.001
71899884|NCT03691623|143322167|SUPERIORITY||LS Mean Difference|-2.46|||<|0.001|TWO_SIDED|95.0|-3.64|-1.29|||ANCOVA|||||-1.29|-3.64|< 0.001
71816975|NCT00406419|143136492|SUPERIORITY||Weighted difference|34.5|||<|0.0001|TWO_SIDED|95.0|27.4|41.5|||Cochran-Mantel-Haenszel|||||41.5|27.4|< 0.0001
71816976|NCT01535274|143136530|SUPERIORITY||||||<|0.001|||||||ANOVA|||P-values represent comparison of successive set points within anesthetic type (i.e.: Set Point 1 compared to Set Point 2, Set Point 2 compared to Set Point 3, etc.). This P-value was determined for each of set points 1, 2, 3, 4, and 5.||||<0.001
71816977|NCT00882921|143136598|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.873||||0.1309|TWO_SIDED|95.0|0.731|11.296|||Negative Binomial Model|||The groups compared are Ab+ vs Ab-||11.296|0.731|0.1309
71816978|NCT00882921|143136598|SUPERIORITY_OR_OTHER_LEGACY||Relative Risk|2.082||||0.2718|TWO_SIDED|95.0|0.563|7.706|||Negative Binomial Model|||The groups compared are Ab+ (age adjusted) vs Ab- (age adjusted)||7.706|0.563|0.2718
71816979|NCT02120664|143136605|SUPERIORITY_OR_OTHER||R squared|0.907|||||TWO_SIDED||||||Regression, Linear|||||||
71816980|NCT02120664|143136606|SUPERIORITY_OR_OTHER||Coefficient of Variation|2.53|||||TWO_SIDED|||||||||||||
71816981|NCT02120664|143136606|SUPERIORITY_OR_OTHER||Coefficient of Variation|6.69|||||TWO_SIDED|||||||||||||
71816982|NCT04524598|143136620|SUPERIORITY||t|-1.911||||0.06|TWO_SIDED||||||Mixed Models Analysis|||A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction. Group and Week were entered as fixed factors. Spark version, and assessment completion days since baseline were included as fixed factors to control for effects of app version and differences in time between completion of successive weekly assessments.||||0.06
71849093|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|4.92|||||TWO_SIDED|95.0|3.34|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||7.26|3.34|
71816983|NCT04524598|143136620|SUPERIORITY||t|-2.546||||0.01|TWO_SIDED||||||Mixed Models Analysis|||We used a Per Protocol approach that included participants who completed the PHQ at baseline and each week. A linear mixed-effects model (LMM) analysis was implemented on an averaged imputed dataset to evaluate main effects of Group (Spark, Control) and Week (0-5), and the Group x Week interaction.||||0.01
71816984|NCT04524598|143136623|SUPERIORITY||F|1.46||||0.23|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on GAD-7 scores to compare the change in anxiety symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.23
71816985|NCT04524598|143136623|SUPERIORITY||F|2.59||||0.11|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS - General Health Score to compare the change in general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.11
71816986|NCT04524598|143136624|SUPERIORITY||F|0.94||||0.33|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Time x Group) on the MFQ to compare the change in parent report of depressive symptoms from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is presented.||||0.33
71816987|NCT04524598|143136624|SUPERIORITY||F|0.02||||0.9|TWO_SIDED||||||ANOVA|||We conducted a repeated measures ANOVA (Group x Time) on the PROMIS Parent Proxy - General Health Score to compare the change in parent reported general health from Baseline to Post treatment for Phase II participants who had a baseline PHQ-8 score \>= 10. The interaction term is reported.||||0.90
71816988|NCT00550550|143136680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|||=|0.001|TWO_SIDED|95.0|-2.6|-0.66|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.66|-2.60|=0.001
71816989|NCT00550550|143136681|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.005|TWO_SIDED|95.0|-1.95|-0.45|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.45|-1.95|=0.005
71816990|NCT00550550|143136682|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||=|0.066|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||0.03|-0.88|=0.066
71816991|NCT00550550|143136683|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|||=|0.042|TWO_SIDED|95.0|-0.6|-0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.||||-0.03|-0.60|=0.042
71816992|NCT00697190|143136692|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|97.5|-0.29|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.04|-0.29|
71816993|NCT00697190|143136693|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|97.5|-0.1|0.06|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.06|-0.10|
71816994|NCT00697190|143136694|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.23|0.1|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.||0.10|-0.23|
71816995|NCT00697190|143136695|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.25|0.04|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.04|-0.25|
71816996|NCT00697190|143136696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.16|0.07|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.07|-0.16|
71816997|NCT00697190|143136697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.25|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.||0.14|-0.25|
71816998|NCT00697190|143136698|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|0.04|0.32|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.32|0.04|
71816999|NCT00697190|143136699|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|97.5|-0.26|0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.08|-0.26|
71817000|NCT00697190|143136700|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Median Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.08||||97.5|0.02|0.33|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.||0.33|0.02|
71817001|NCT00697190|143136701|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|97.5|-0.27|0.26|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||0.26|-0.27|
71817002|NCT00697190|143136702|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.34|-0.08|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.08|-0.34|
71817003|NCT00697190|143136703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|97.5|-0.54|-0.15|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.||-0.15|-0.54|
71817004|NCT00697190|143136704|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.12|0.14|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.14|-0.12|
71817005|NCT00697190|143136705|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|97.5|-0.23|0.05|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.05|-0.23|
71817006|NCT00697190|143136706|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|97.5|-0.2|0.02|||Mixed Models Analysis||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.||0.02|-0.20|
71817007|NCT02714205|143136720|SUPERIORITY||Model generated Least Square Mean|-0.54||||0.34|TWO_SIDED|95.0|-1.66|0.58|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.58|-1.66|0.34
71817008|NCT02714205|143136721|SUPERIORITY||Model generated Least Square Mean|0.51||||0.88|TWO_SIDED|95.0|-6.15|7.18|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|||7.18|-6.15|0.88
71817009|NCT02714205|143136722|SUPERIORITY||Model generated Least Square Mean|-0.2||||0.57|TWO_SIDED|95.0|-0.88|0.48|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.48|-0.88|0.57
71817010|NCT02714205|143136723|SUPERIORITY||Model generated Least Square Mean Differ|-0.09||||0.81|TWO_SIDED|95.0|-0.8|0.63|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.63|-0.8|0.81
71817011|NCT02714205|143136724|SUPERIORITY||Model generated Least Square Mean Differ|0.43||||0.3|TWO_SIDED|95.0|-0.38|1.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||1.23|-0.38|0.3
71817012|NCT02714205|143136725|SUPERIORITY||Model generated Least Square Mean Differ|0.4||||0.68|TWO_SIDED|95.0|-1.52|2.32|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||2.32|-1.52|0.68
71817013|NCT02714205|143136726|SUPERIORITY||Model generated Least Square Mean Differ|-0.83||||0.12|TWO_SIDED|95.0|-1.89|0.23|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.23|-1.89|0.12
71849094|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.73|||||TWO_SIDED|95.0|2.08|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.57|2.08|
71849095|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.82|||||TWO_SIDED|95.0|2.08|3.83|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.83|2.08|
71899885|NCT03691623|143322168|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
71679396|NCT02045862|142876833|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.009|TWO_SIDED|95.0|-0.36|0.09||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate||0.09|-0.36|0.009
71899886|NCT03691623|143322168|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
71899887|NCT03691623|143322168|SUPERIORITY||||||=|0.001|||||||Log Rank|||||||= 0.001
71899888|NCT03691623|143322168|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
71899889|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0126|TWO_SIDED|95.0|0.833|0.978|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.833|0.0126
71899890|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.966||||0.0042|TWO_SIDED|95.0|0.944|0.989|||Regression, Logistic|||The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.944|0.0042
71899891|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732|||<|0.0001|TWO_SIDED|95.0|0.656|0.816|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.816|0.656|<0.0001
71899892|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.686|||<|0.0001|TWO_SIDED|95.0|1.347|2.109|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.109|1.347|<0.0001
71899893|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103||||0.4759|TWO_SIDED|95.0|0.843|1.442|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.442|0.843|0.4759
71899894|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.656||||0.018|TWO_SIDED|95.0|0.462|0.93|||Regression, Logistic|||The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.930|0.462|0.0180
71899895|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.742||||0.0262|TWO_SIDED|95.0|0.57|0.965|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.965|0.570|0.0262
71899896|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.717||||0.0069|TWO_SIDED|95.0|0.563|0.913|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.563|0.0069
71899897|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.062|||<|0.0001|TWO_SIDED|95.0|1.056|1.067|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.067|1.056|<0.0001
71899898|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.107||||0.0062|TWO_SIDED|95.0|1.029|1.191|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.191|1.029|0.0062
71899899|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.739||||0.0295|TWO_SIDED|95.0|0.563|0.97|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.563|0.0295
71899900|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.166|||<|0.0001|TWO_SIDED|95.0|0.083|0.329|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.329|0.083|<0.0001
71817014|NCT02714205|143136727|SUPERIORITY||Model generated Least Square Mean Differ|-1.41||||0.25|TWO_SIDED|95.0|-3.81|0.99|||Mixed Models Analysis|Mixed Models adjusted for baseline value, age, race, and Hispanic ethnicity. Repeated measures mixed models, with unstructured co-variance matrix|Model generated LS Mean Differences|||0.99|-3.81|0.25
71817015|NCT00381641|143136729|SUPERIORITY|"Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.~Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative."|||||<|0.1||||||"For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.~For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed."|Simon, two-stage design|||Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.||||<0.10
71817016|NCT01598298|143136734|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-0.82||||0.0002|TWO_SIDED|95.0|-1.24|-0.4||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.||-0.40|-1.24|0.0002
71817017|NCT01598298|143136735|OTHER|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.57|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.||-0.55|-1.57|<0.0001
71849096|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|3.79|||||TWO_SIDED|95.0|2.8|5.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||5.13|2.80|
71849097|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.32|||||TWO_SIDED|95.0|1.11|1.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.57|1.11|
71849098|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.3|||||TWO_SIDED|95.0|1.05|1.61|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1.61|1.05|
71849099|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.04|||||TWO_SIDED|95.0|1.51|2.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.75|1.51|
71849100|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|2.87|||||TWO_SIDED|95.0|2.19|3.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||3.77|2.19|
71817018|NCT01598298|143136736|OTHER|Two-sided test at the alpha=0.05 level|Coefficient fro treatment term|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.35|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.||-0.55|-1.35|<0.0001
71817019|NCT00708721|143136770|OTHER||Maximum Tolerated Dose|1.0|||||TWO_SIDED||||||||Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.|||||
71817020|NCT04105972|143136777|SUPERIORITY||Least Squares (LS) Mean Difference|15.9|||<|0.0001|TWO_SIDED|95.0|11.7|20.1|||Mixed-effects Model for Repeated Measure|||||20.1|11.7|< 0.0001
71817021|NCT04105972|143136778|SUPERIORITY||LS Mean Difference|10.2|||<|0.0001|TWO_SIDED|95.0|8.2|12.1|||Mixed-effects Model for Repeated Measure|||||12.1|8.2|<0.0001
71817022|NCT04105972|143136779|SUPERIORITY||LS Mean Difference|-42.8|||||TWO_SIDED|95.0|-46.2|-39.3||||||||-39.3|-46.2|
71817023|NCT02341287|143136781|SUPERIORITY||Mean Difference (Net)|14.01|STANDARD_DEVIATION|19.4||0.023|TWO_SIDED|95.0|2.29|25.74||Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by actigraph.|t-test, 2 sided|||||25.74|2.29|.023
71817024|NCT02341287|143136782|SUPERIORITY|Paired t-test of control average sleep latency vs. heated glove average sleep latency as measured by sleep log.|Mean Difference (Net)|13.51|STANDARD_DEVIATION|16.91|<|0.014|TWO_SIDED|95.0|3.29|23.73|||t-test, 2 sided|||||23.73|3.29|<0.014
71817025|NCT02687412|143136783|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
71817026|NCT02687412|143136784|SUPERIORITY||Mean Difference (Final Values)|-4041.0|STANDARD_ERROR_OF_MEAN|1831.042||0.029|TWO_SIDED|95.0|-7672.301|-411.065|||t-test, 2 sided|||||-411.065|-7672.301|0.029
71817027|NCT02687412|143136785|SUPERIORITY||Mean Difference (Final Values)|20.3739|STANDARD_ERROR_OF_MEAN|6.4198||0.002|TWO_SIDED|95.0|7.6414|33.1065|||t-test, 2 sided|||||33.1065|7.6414|0.002
71817028|NCT02687412|143136786|SUPERIORITY|||||||0.014|||||||Chi-squared|||||||0.014
71817029|NCT02687412|143136787|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
71817030|NCT02687412|143136788|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71817031|NCT02687412|143136789|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71817032|NCT02687412|143136790|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71849101|NCT00824850|143211886|SUPERIORITY_OR_OTHER||geometric mean fold rise|1.95|||||TWO_SIDED|95.0|1.59|2.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||2.39|1.59|
71817033|NCT02687412|143136791|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71817034|NCT02687412|143136792|SUPERIORITY||Mean Difference (Final Values)|-0.10046|STANDARD_ERROR_OF_MEAN|0.1915||0.601|TWO_SIDED|95.0|-0.4819|0.2817|||t-test, 2 sided|||||0.2817|-0.4819|0.601
71817035|NCT02687412|143136793|SUPERIORITY||Mean Difference (Final Values)|164.746|STANDARD_ERROR_OF_MEAN|317.79||0.605|TWO_SIDED|95.0|-465.0|794.0|||t-test, 2 sided|||||794|-465|0.605
71817036|NCT01966796|143136807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||The incidence of MDR pathogens (6.7%, 25.5%, 36.9% and 44.6% in PSI II, III, IV, and V, respectively, p=0.002) and mortality rate (0, 5.9%, 12.3%, and 23.8%, respectively, p\<0.001) increased with increasing PSI||||0.002
71817037|NCT00474929|143136808|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose (MTD) Level|1.0|||||TWO_SIDED||||||||Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).||||
71817038|NCT01161472|143136815|SUPERIORITY_OR_OTHER||Least square (LS) Mean Difference|-0.0285|STANDARD_ERROR_OF_MEAN|0.018||0.1198|TWO_SIDED|95.0|-0.0647|0.0077|||ANCOVA|||Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0077|-0.0647|0.1198
71817039|NCT01161472|143136815|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0203|STANDARD_ERROR_OF_MEAN|0.0173||0.2459|TWO_SIDED|95.0|-0.0551|0.0145|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0145|-0.0551|0.2459
71817040|NCT01161472|143136817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0037|STANDARD_ERROR_OF_MEAN|0.0115||0.7502|TWO_SIDED|95.0|-0.0268|0.0194|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0194|-0.0268|0.7502
71817041|NCT01161472|143136817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0085|STANDARD_ERROR_OF_MEAN|0.0119||0.4785|TWO_SIDED|95.0|-0.0325|0.0154|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0154|-0.0325|0.4785
71817042|NCT01161472|143136819|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0035|STANDARD_ERROR_OF_MEAN|0.0265||0.8944|TWO_SIDED|95.0|-0.0569|0.0498|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0498|-0.0569|0.8944
71817043|NCT01161472|143136819|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0209|STANDARD_ERROR_OF_MEAN|0.0263||0.4308|TWO_SIDED|95.0|-0.032|0.0738|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||0.0738|-0.0320|0.4308
71817044|NCT01161472|143136821|SUPERIORITY_OR_OTHER||LS Mean Difference|3.6629|STANDARD_ERROR_OF_MEAN|12.4945||0.7707|TWO_SIDED|95.0|-21.4729|28.7987|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||28.7987|-21.4729|0.7707
71817045|NCT01161472|143136821|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.921|STANDARD_ERROR_OF_MEAN|12.4482||0.1162|TWO_SIDED|95.0|-44.9634|5.1215|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||5.1215|-44.9634|0.1162
71817046|NCT01161472|143136823|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0068|STANDARD_ERROR_OF_MEAN|4.8707||0.9989|TWO_SIDED|95.0|-9.8297|9.8433|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||9.8433|-9.8297|0.9989
71817047|NCT01161472|143136823|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6251|STANDARD_ERROR_OF_MEAN|5.0346||0.7485|TWO_SIDED|95.0|-11.7926|8.5425|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||8.5425|-11.7926|0.7485
71817048|NCT01161472|143136825|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2684|STANDARD_ERROR_OF_MEAN|0.8243||0.7458|TWO_SIDED|95.0|-1.3788|1.9157|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.9157|-1.3788|0.7458
71817049|NCT01161472|143136825|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0661|STANDARD_ERROR_OF_MEAN|0.8277||0.9366|TWO_SIDED|95.0|-1.7202|1.588|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.||1.5880|-1.7202|0.9366
71679397|NCT02045862|142876834|SUPERIORITY||Rate Ratio|0.62|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|0.48|0.79|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable||0.79|0.48|<0.001
71817050|NCT02002884|143136870|SUPERIORITY||LS Mean difference|-0.22|||=|0.017|TWO_SIDED|95.0|-0.4|-0.04|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, Gross Motor Function Classification System-Extended and Revised (GMFCS-E\&R) level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||-0.04|-0.4|= 0.017
71817051|NCT02002884|143136870|SUPERIORITY||LS-Mean difference|-0.07|||=|0.546|TWO_SIDED|95.0|-0.29|0.15|||MMRM|||LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, GMFCS-E\&R level at screening included as covariates. For MMRM visit\*treatment is interaction term repeated factor.||0.15|-0.29|= 0.546
71817052|NCT02002884|143136871|SUPERIORITY||LS-Mean difference|0.09|||=|0.34|TWO_SIDED|95.0|-0.1|0.28|||ANCOVA|||LS-Means are from analysis of covariance (ANCOVA) with treatment group, pooled site and pretreatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.28|-0.1|= 0.34
71817053|NCT02002884|143136871|SUPERIORITY||LS-Mean difference|-0.12|||=|0.297|TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||LS-Means are from ANCOVA with treatment group, pooled site and pre-treatment status included as fixed factors and maximum AS score of the two possible primary target patterns flexed elbow or flexed wrist baseline, GMFCS-E\&R level at screening included as covariates.||0.11|-0.36|= 0.297
71817054|NCT02966002|143136885|OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
71817055|NCT02966002|143136886|OTHER|||||||0.67|||||||t-test, 2 sided|||||||0.67
71817056|NCT02966002|143136887|OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71817057|NCT02966002|143136888|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71817058|NCT03377790|143136906|SUPERIORITY||||||<|0.0001||||||Differences between treatments arms are compared using a chi-square test.|Chi-squared|||||||<0.0001
71817059|NCT03377790|143136907|SUPERIORITY|||||||0.0067|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0067
71817060|NCT03377790|143136908|SUPERIORITY|||||||0.0152|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0152
71817061|NCT03377790|143136909|SUPERIORITY|||||||0.0302|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0302
71817062|NCT03377790|143136910|SUPERIORITY|||||||0.5921|||||||ANCOVA|Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.||||||0.5921
71817063|NCT03377790|143136911|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
71817064|NCT03377790|143136912|SUPERIORITY||||||<|0.0001|||||||ANCOVA|Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.||||||<0.0001
71817065|NCT03377790|143136913|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
71817066|NCT03377790|143136914|SUPERIORITY||||||<|0.0001|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||<0.0001
71817067|NCT03377790|143136915|SUPERIORITY|||||||0.052|||||||Chi-squared|Differences between treatments arms are compared using a chi-square test.||||||0.0520
71817068|NCT02632786|143136916|SUPERIORITY||Risk Ratio (RR)|0.82||||0.319|TWO_SIDED|95.0|0.55|1.21|||Cochran-Mantel-Haenszel|||||1.21|0.55|0.3190
71817069|NCT02632786|143136917|SUPERIORITY||Mean Difference (Net)|-0.78||||0.5563|TWO_SIDED|95.0|-3.37|1.81|||Mixed Models Analysis|||||1.81|-3.37|0.5563
71817070|NCT02632786|143136918|SUPERIORITY||Mean Difference (Net)|5.0||||0.8992|TWO_SIDED|95.0|-11.5|23.0|||ANCOVA|||||23.00|-11.50|0.8992
71817071|NCT02632786|143136919|SUPERIORITY||Risk Ratio (RR)|1.54||||0.3529|TWO_SIDED|95.0|0.6|3.94|||Cochran-Mantel-Haenszel|||||3.94|0.60|0.3529
71817072|NCT02632786|143136920|SUPERIORITY||Mean Difference (Net)|-0.6||||0.757|TWO_SIDED|95.0|-4.2|3.0|||Mixed Models Analysis|||||3.0|-4.2|0.7570
71817073|NCT02632786|143136921|SUPERIORITY||Slope|-71.97||||0.0729|TWO_SIDED|95.0|-150.72|6.79|||Mixed Models Analysis|||||6.79|-150.72|0.0729
71817074|NCT02632786|143136922|SUPERIORITY|||||||0.4142|||||||Cochran-Mantel-Haenszel|||||||0.4142
71817075|NCT02265224|143136923|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|89.81||||0.0136|TWO_SIDED|94.12|82.82|97.4||p value for treatment effect|ANOVA|||||97.40|82.82|0.0136
71817076|NCT02265224|143136924|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|90.79||||0.0047|TWO_SIDED|94.12|85.25|96.69|||ANOVA|p value for treatment effect||||96.69|85.25|0.0047
71817077|NCT02265224|143136925|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.|Geometric means ratio|91.86||||0.0095|TWO_SIDED|94.12|86.45|97.61||p value for treatment effect|ANOVA|||||97.61|86.45|0.0095
71679398|NCT02045862|142876834|SUPERIORITY||Rate Ratio|0.75|STANDARD_ERROR_OF_MEAN|0.13||0.023|TWO_SIDED|95.0|0.58|0.96|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable||0.96|0.58|0.023
71679399|NCT02045862|142876835|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.51|-1.46||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.46|-4.51|<0.001
71679400|NCT02045862|142876835|SUPERIORITY||Stratified Rank ANCOVA|-0.93|STANDARD_ERROR_OF_MEAN|0.78||0.006|TWO_SIDED|95.0|-2.47|0.61||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.61|-2.47|0.006
71817078|NCT02265224|143136926|EQUIVALENCE|The statistical analysis took into account treatment, period, sequence and subject (sequence) as sources of variation. Acceptance criterion for bioequivalence was that the 94.12% confidence interval for the ratio between test and reference of the geometric means of the parameters under consideration fell within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies and to the Pocock α spending function.||||||0.505|||||||Friedman test|||||||0.5050
71817079|NCT01454830|143136947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.44||0.2|TWO_SIDED||||||t-test, 2 sided||unit of measurement, hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.20
71817080|NCT01454830|143136948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.48||0.9|TWO_SIDED||||||t-test, 2 sided||unit of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.90
71817081|NCT01454830|143136949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.53||0.89|TWO_SIDED||||||t-test, 2 sided||units of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial||||0.89
71817082|NCT01454830|143136950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|4.09||0.78|TWO_SIDED||||||t-test, 2 sided||units of measurement: % TST; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).||||0.78
71817083|NCT00569803|143136984|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.86|||||TWO_SIDED|90.0|0.68|1.08|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.08|0.68|
71817084|NCT00569803|143136984|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
71817085|NCT00569803|143136984|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.78|||||TWO_SIDED|90.0|0.62|0.99|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||0.99|0.62|
71817086|NCT00569803|143136984|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.89|||||TWO_SIDED|90.0|0.71|1.13|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.13|0.71|
71817087|NCT00569803|143136984|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.11|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.11|0.69|
71817088|NCT00569803|143136984|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
71817089|NCT00569803|143136985|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.87|||||TWO_SIDED|90.0|0.69|1.1|||||Ratio of Geometric Means: 50mg SC over 125mg IV|||1.10|0.69|
71817090|NCT00569803|143136985|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.61|||||TWO_SIDED|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV|||0.77|0.48|
71817091|NCT00569803|143136985|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.79|||||TWO_SIDED|90.0|0.62|1.0|||||Ratio of Geometric Means: 125mg SC over 125mg IV|||1.00|0.62|
71817092|NCT00569803|143136985|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.71|1.14|||||Ratio of Geometric Means: 150mg SC over 125mg IV|||1.14|0.71|
71817093|NCT00569803|143136985|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.88|||||TWO_SIDED|90.0|0.69|1.12|||||Ratio of Geometric Means: 200mg SC over 125mg IV|||1.12|0.69|
71817094|NCT00569803|143136985|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.73|||||TWO_SIDED|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV|||0.92|0.57|
71817095|NCT00569803|143136991|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
71817096|NCT00569803|143136991|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|0.9|||||TWO_SIDED|90.0|0.75|1.07|||||AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites|||1.07|0.75|
71817097|NCT02006420|143137000|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin thickness of the forearm.||||0.005
71679401|NCT02045862|142876837|SUPERIORITY||Odds Ratio (OR)|1.44||||0.002|TWO_SIDED|95.0|1.14|1.8|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.8|1.14|0.002
71679402|NCT02045862|142876837|SUPERIORITY||Odds Ratio (OR)|1.37||||0.007|TWO_SIDED|95.0|1.09|1.73|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.73|1.09|0.007
71679403|NCT02045862|142876838|SUPERIORITY||Least Squares Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.16|-0.41|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.41|-1.16|<0.001
71679404|NCT02045862|142876838|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.037|TWO_SIDED|95.0|-0.77|-0.02|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.||-0.02|-0.77|0.037
71679405|NCT02045862|142876840|SUPERIORITY||Least Squares Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.37|-1.10|<0.001
71679406|NCT02045862|142876840|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.036|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.03|-0.76|0.036
71679407|NCT02045862|142876841|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.059|TWO_SIDED|95.0|-0.19|0.0|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.00|-0.19|0.059
71817098|NCT02006420|143137000|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin stiffness of the thigh||||0.71
71817099|NCT02006420|143137001|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p-value for the forearm||||0.002
71817100|NCT02006420|143137001|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p-value for the thigh||||0.007
71679408|NCT02045862|142876841|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.068|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-0.19|0.068
71688681|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.23|0.33|||t-test, 2 sided|||FEV1 Day 8 (0.25 hrs post-dose)||0.33|0.23|<0.0001
71817101|NCT02006420|143137002|SUPERIORITY|||||||0.002|||||||Pearson correlation|||This is the p value for the forearm.||||0.002
71817102|NCT02006420|143137002|SUPERIORITY|||||||0.007|||||||Pearson correlation|||This is the p value for the thigh||||0.007
71817103|NCT02006420|143137004|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the forearm||||<.0001
71817104|NCT02006420|143137004|SUPERIORITY||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the thigh||||<0.0001
71849102|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|201.8|||||TWO_SIDED|95.0|55.11|739.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||739.05|55.11|
71849103|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.7|||||TWO_SIDED|95.0|5.2|26.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||26.10|5.20|
71817105|NCT02006420|143137006|SUPERIORITY|||||||0.01|||||||Pearson correlation|||This is the p-value for the forearm||||0.01
71817106|NCT02006420|143137006|SUPERIORITY|||||||0.1|||||||Pearson correlation|||This is the p-value for the thigh||||0.10
71817107|NCT00791921|143137021|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||For ACR20 responder rate at Week 12, comparison between the CDP870 200 mg group and the placebo group was performed.||||<0.05
71817108|NCT00791921|143137022|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Regression, Logistic|||||||<0.05
71817109|NCT01965158|143137024|SUPERIORITY_OR_OTHER||Difference|13.0|STANDARD_ERROR_OF_MEAN|4.19||0.002|TWO_SIDED|95.0|4.8|21.3||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.||||21.3|4.8|0.0020
71817110|NCT01965158|143137025|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.271|<|0.0001|TWO_SIDED|95.0|0.77|1.83|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.83|0.77|<0.0001
71817111|NCT01965158|143137026|SUPERIORITY_OR_OTHER||LS Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|1.6|2.63|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||2.63|1.60|<0.0001
71817112|NCT01965158|143137027|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.54|1.48|||ANCOVA|ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.48|0.54|<0.0001
71817113|NCT01965158|143137028|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.198||0.0003|TWO_SIDED|95.0|0.34|1.12|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.||||1.12|0.34|0.0003
71817114|NCT00474175|143137029|SUPERIORITY_OR_OTHER||Treatment difference|16.46|||<|0.001|TWO_SIDED|95.0|7.2|25.7||Alternative hypotheses tested in the study was that benzocaine 20% was significantly (p less than or equal to \[=\<\] 0.05) more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and its associated confidence interval (C.I.) was calculated based on CMH weighted percentages and the corresponding standard error.||25.7|7.2|<0.001
71817115|NCT00474175|143137029|SUPERIORITY_OR_OTHER||Treatment difference|9.8||||0.038|TWO_SIDED|95.0|0.3|19.3||Alternative hypotheses tested in the study was that benzocaine 10% was significantly (p=\<0.05) more effective than placebo provided that benzocaine 20% was more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||19.3|0.3|0.038
71817116|NCT00474175|143137029|SUPERIORITY_OR_OTHER||Treatment difference|6.72||||0.047|TWO_SIDED|95.0|0.2|13.3|||Cochran-Mantel-Haenszel|Dose response was considered established if the percentage of responders between the 20% and 10% was greater than or equal to 5%.||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.||13.3|0.2|0.047
71817117|NCT00474175|143137030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.55|2.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. Hazard Ratio (HR) of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.64|1.55|<0.001
71817118|NCT00474175|143137030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.63|||<|0.001|TWO_SIDED|95.0|1.26|2.12||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.12|1.26|<0.001
71817119|NCT00474175|143137030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.24||||0.03|TWO_SIDED|95.0|1.02|1.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.51|1.02|0.030
71817120|NCT00474175|143137031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.04|||<|0.001|TWO_SIDED|95.0|1.57|2.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.66|1.57|<0.001
71817121|NCT00474175|143137031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73|||<|0.001|TWO_SIDED|95.0|1.34|2.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.||2.25|1.34|<0.001
71817122|NCT00474175|143137031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.1|TWO_SIDED|95.0|0.97|1.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.||1.43|0.97|0.100
71817123|NCT00474175|143137033|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.035|TWO_SIDED|95.0|0.03|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using Analysis of Variance (ANOVA) which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|0.03|0.035
71817124|NCT00474175|143137033|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.173|TWO_SIDED|95.0|-0.14|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.14|0.173
71817125|NCT00474175|143137033|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.358|TWO_SIDED|95.0|-0.2|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.20|0.358
71817126|NCT00474175|143137033|SUPERIORITY_OR_OTHER||Treatment difference|0.75||||0.135|TWO_SIDED|95.0|-0.23|1.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.72|-0.23|0.135
71817127|NCT00474175|143137033|SUPERIORITY_OR_OTHER||Treatment difference|0.48||||0.332|TWO_SIDED|95.0|-0.49|1.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.46|-0.49|0.332
71817128|NCT00474175|143137033|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.517|TWO_SIDED|95.0|-0.53|1.06||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.06|-0.53|0.517
71817129|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.35|0.50|<0.001
71817130|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.55||||0.011|TWO_SIDED|95.0|0.13|0.97||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.97|0.13|0.011
71817131|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.031|TWO_SIDED|95.0|0.03|0.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.72|0.03|0.031
71849104|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|156.4|||||TWO_SIDED|95.0|48.72|501.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||501.86|48.72|
71849105|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.4|||||TWO_SIDED|95.0|13.71|102.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||102.31|13.71|
71849106|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|93.9|||||TWO_SIDED|95.0|30.99|284.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||284.31|30.99|
71849107|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|48.7|||||TWO_SIDED|95.0|23.27|101.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||101.97|23.27|
71817132|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.78|||<|0.001|TWO_SIDED|95.0|0.33|1.23||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.23|0.33|<0.001
71817133|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.49||||0.031|TWO_SIDED|95.0|0.04|0.94||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.94|0.04|0.031
71817134|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.29||||0.119|TWO_SIDED|95.0|-0.07|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.07|0.119
71817135|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.77||||0.002|TWO_SIDED|95.0|0.28|1.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.25|0.28|0.002
71817136|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.061|TWO_SIDED|95.0|-0.02|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.95|-0.02|0.061
71817137|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.3||||0.131|TWO_SIDED|95.0|-0.09|0.7||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.70|-0.09|0.131
71817138|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.52||||0.044|TWO_SIDED|95.0|0.01|1.03||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.03|0.01|0.044
71849108|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|32.1|||||TWO_SIDED|95.0|11.99|85.81|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||85.81|11.99|
71849109|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.1|||||TWO_SIDED|95.0|50.42|120.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.94|50.42|
71849110|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|10.3|||||TWO_SIDED|95.0|6.8|15.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||15.72|6.80|
71849111|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.7|||||TWO_SIDED|95.0|32.75|116.34|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||116.34|32.75|
71849112|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|536.5|||||TWO_SIDED|95.0|212.04|1357.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1357.19|212.04|
71849113|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.9|||||TWO_SIDED|95.0|33.28|410.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||410.33|33.28|
71849114|NCT00824850|143211887|SUPERIORITY_OR_OTHER||geometric mean fold rise|24.6|||||TWO_SIDED|95.0|11.3|53.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||53.42|11.30|
71817139|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.43||||0.099|TWO_SIDED|95.0|-0.08|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.08|0.099
71817140|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.647|TWO_SIDED|95.0|-0.32|0.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.51|-0.32|0.647
71817141|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.6||||0.023|TWO_SIDED|95.0|0.08|1.11||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.11|0.08|0.023
71817142|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.47||||0.072|TWO_SIDED|95.0|-0.04|0.98||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.98|-0.04|0.072
71817143|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.13||||0.551|TWO_SIDED|95.0|-0.29|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.29|0.551
71817144|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.54||||0.047|TWO_SIDED|95.0|0.01|1.08||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.08|0.01|0.047
71817145|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.316|TWO_SIDED|95.0|-0.26|0.81||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.81|-0.26|0.316
71817146|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.27||||0.224|TWO_SIDED|95.0|-0.17|0.71||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.71|-0.17|0.224
71817147|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.46||||0.099|TWO_SIDED|95.0|-0.09|1.01||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||1.01|-0.09|0.099
71817148|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.37||||0.186|TWO_SIDED|95.0|-0.18|0.92||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.92|-0.18|0.186
71899901|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.049||||0.0048|TWO_SIDED|95.0|1.015|1.084|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.084|1.015|0.0048
71817149|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.684|TWO_SIDED|95.0|-0.35|0.54||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.54|-0.35|0.684
71899902|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.797||||0.0019|TWO_SIDED|95.0|2.136|28.458|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||28.458|2.136|0.0019
71817150|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.452|TWO_SIDED|95.0|-0.34|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.34|0.452
71817151|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.479|TWO_SIDED|95.0|-0.35|0.75||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.75|-0.35|0.479
71817152|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.01||||0.955|TWO_SIDED|95.0|-0.44|0.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.46|-0.44|0.955
71817153|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.465|TWO_SIDED|95.0|-0.36|0.79||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.79|-0.36|0.465
71817154|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.992|TWO_SIDED|95.0|-0.57|0.58||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.58|-0.57|0.992
71817155|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.21||||0.376|TWO_SIDED|95.0|-0.26|0.68||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.68|-0.26|0.376
71817156|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.36||||0.229|TWO_SIDED|95.0|-0.22|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.93|-0.22|0.229
71849115|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|168.8|||||TWO_SIDED|95.0|20.22|1409.76|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1409.76|20.22|
71849116|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|40.3|||||TWO_SIDED|95.0|10.97|148.44|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||148.44|10.97|
71817157|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.581|TWO_SIDED|95.0|-0.41|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.41|0.581
71817158|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.19||||0.422|TWO_SIDED|95.0|-0.28|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.66|-0.28|0.422
71817159|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.33||||0.271|TWO_SIDED|95.0|-0.26|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.26|0.271
71817160|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.612|TWO_SIDED|95.0|-0.43|0.73||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.73|-0.43|0.612
71849117|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.9|||||TWO_SIDED|95.0|18.83|203.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.72|18.83|
71899903|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
71817161|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.18||||0.465|TWO_SIDED|95.0|-0.3|0.65||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.65|-0.30|0.465
71817162|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.32||||0.29|TWO_SIDED|95.0|-0.27|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.91|-0.27|0.290
71849118|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|26.7|||||TWO_SIDED|95.0|9.67|73.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.84|9.67|
71817163|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.412|TWO_SIDED|95.0|-0.34|0.83||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.83|-0.34|0.412
71817164|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.07||||0.769|TWO_SIDED|95.0|-0.41|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.55|-0.41|0.769
71817165|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.15||||0.61|TWO_SIDED|95.0|-0.43|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.74|-0.43|0.610
71817166|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.2||||0.511|TWO_SIDED|95.0|-0.39|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.78|-0.39|0.511
71817167|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.859|TWO_SIDED|95.0|-0.52|0.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.43|-0.52|0.859
71817168|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.26||||0.386|TWO_SIDED|95.0|-0.33|0.84||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.84|-0.33|0.386
71817169|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.563|TWO_SIDED|95.0|-0.41|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.76|-0.41|0.563
71817170|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.56|-0.39|0.721
71899904|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
71817171|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.1||||0.725|TWO_SIDED|95.0|-0.48|0.69||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.69|-0.48|0.725
71817172|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.06||||0.839|TWO_SIDED|95.0|-0.52|0.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.64|-0.52|0.839
71817173|NCT00474175|143137035|SUPERIORITY_OR_OTHER||Treatment difference|0.04||||0.855|TWO_SIDED|95.0|-0.43|0.52||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.||0.52|-0.43|0.855
71817174|NCT00474175|143137036|SUPERIORITY_OR_OTHER||Treatment difference|0.17||||0.035|TWO_SIDED|95.0|0.01|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|0.01|0.035
71817175|NCT00474175|143137036|SUPERIORITY_OR_OTHER||Treatment difference|0.16||||0.039|TWO_SIDED|95.0|0.0|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.33|-0.00|0.039
71817176|NCT00474175|143137036|SUPERIORITY_OR_OTHER||Treatment difference|-0.01||||0.944|TWO_SIDED|95.0|-0.15|0.13||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic.||0.13|-0.15|0.944
71817177|NCT01622543|143137039|SUPERIORITY||Hazard Ratio (HR)|1.59||||0.046|TWO_SIDED|95.0|1.0|2.53|||Log Rank|||||2.53|1.00|0.046
71817178|NCT01622543|143137040|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71817179|NCT01622543|143137041|SUPERIORITY||Odds Ratio (OR)|2.09||||0.06|TWO_SIDED|95.0|0.96|4.55|||Cochran-Mantel-Haenszel|||||4.55|0.96|0.06
71817180|NCT01622543|143137042|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.36|TWO_SIDED|95.0|0.78|1.98|||Log Rank|||||1.98|0.78|0.36
71817181|NCT01027364|143137092|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.17|||<|0.001|TWO_SIDED|95.0|0.11|0.24||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have \> 95% power at the 2-sided 0.05 level of significance, based upon this hypothesis test.||0.24|0.11|<0.001
71817182|NCT01027364|143137092|SUPERIORITY_OR_OTHER_LEGACY||Bleeding Rate Ratio|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.2||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations.||0.20|0.08|<0.001
71817183|NCT01121484|143137117|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||Null hypothesis: no difference between treatment groups||||0.004
71817184|NCT01121484|143137118|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.|Cochran-Mantel-Haenszel|||||||<0.001
71817185|NCT01121484|143137119|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
71817186|NCT01121484|143137120|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.002
71817187|NCT01121484|143137121|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||0.158
71817188|NCT01121484|143137122|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||||||<0.001
71817189|NCT01396395|143137162|SUPERIORITY_OR_OTHER||Ratio|0.503|||<|0.0001|TWO_SIDED|95.0|0.435|0.581|||poisson regression: Non-calibration mode|||||0.581|0.435|<0.0001
71817190|NCT01396395|143137162|SUPERIORITY_OR_OTHER||Ratio|0.503|||=|0.0086|TWO_SIDED|95.0|0.301|0.84|||Poisson regression: Calibration model|||||0.840|0.301|=0.0086
71817191|NCT00856661|143137208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.229|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if alive, or 6, if otherwise = death||All patients who were treated and had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included.||2.64|0.79|0.2290
71817192|NCT00856661|143137209|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.9401|TWO_SIDED|95.0|0.59|1.62|||Regression, Logistic|||||1.62|0.59|0.9401
71817193|NCT00856661|143137210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.5076|TWO_SIDED|95.0|0.68|2.18|||Regression, Logistic|||All patients treated, who had at least one valid post-baseline assessment of the mRS and with a baseline NIHSS score of 8 to 24. If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if the patient was known to be alive, or 6, if otherwise = dead.||2.18|0.68|0.5076
71817194|NCT00856661|143137211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.6146|TWO_SIDED|95.0|0.72|1.75|||Regression, Logistic|||all patients treated, who had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included||1.75|0.72|0.6146
71817195|NCT02090634|143137215|SUPERIORITY|||||||0.95||||||Cliff's d = 0.01; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to ARV medications.||||0.95
71899905|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
71899906|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
71899907|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
71817196|NCT02090634|143137215|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Cliff's d = -0.13; calculated to estimate the effect size for between-group comparisons with non-parametric data||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall adherence to PSY medications.||||0.43
71817197|NCT02090634|143137216|SUPERIORITY|||||||0.02||||||Cliff's d = 0.37; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for ARV medications.||||0.02
71817198|NCT02090634|143137216|SUPERIORITY|||||||0.42||||||Cliff's d = 0.14; calculated to estimate the effect size for between-group comparisons with non-parametric data|Wilcoxon (Mann-Whitney)|||We conducted Wilcoxon rank sum (Mann-Whitney) tests in order to examine group (i.e., iTAB vs. CTRL) differences on overall dose timing windows for PSY medications.||||0.42
71817199|NCT01518946|143137225|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|521.0||||0.0131|TWO_SIDED|95.0|124.2|917.7|||ANOVA|||||917.7|124.2|0.0131
71817200|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.8|3.9||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||3.9|-3.8|
71817201|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.1|3.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.7|-7.1|
71817202|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.1||||||95.0|-13.4|5.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||5.1|-13.4|
71817203|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.3||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.3|-3.2|
71817204|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.1||||||95.0|-4.5|7.1||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated||7.1|-4.5|
71817205|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
71817206|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||3.2|-3.2|
71817207|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.5||||||95.0|-7.9|4.8||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||4.8|-7.9|
71899908|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
71899909|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.047|||<|0.0001|TWO_SIDED|95.0|1.029|1.065|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.065|1.029|<0.0001
71899910|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.896||||0.0074|TWO_SIDED|95.0|0.827|0.971|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.971|0.827|0.0074
71899911|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.971||||0.0088|TWO_SIDED|95.0|0.95|0.993|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.950|0.0088
71899912|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.719|||<|0.0001|TWO_SIDED|95.0|0.643|0.803|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.803|0.643|<0.0001
71817208|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||3.2|-3.2|
71817209|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.1||||||95.0|-10.0|3.4||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated||3.4|-10.0|
71817210|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-0.5|7.6||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated||7.6|-0.5|
71817211|NCT00384059|143137226|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.0||||||95.0|-4.1|6.5||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||6.5|-4.1|
71817212|NCT00384059|143137227|SUPERIORITY_OR_OTHER||Difference|-5.3||||||95.0|-19.7|8.8||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.8|-19.7|
71817213|NCT00384059|143137227|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-8.0|8.1||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated||8.1|-8.0|
71899913|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.683|||<|0.0001|TWO_SIDED|95.0|1.346|2.106|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.106|1.346|<0.0001
71817214|NCT00384059|143137228|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.5|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated||3.8|-3.5|
71899914|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.4479|TWO_SIDED|95.0|0.848|1.453|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.453|0.848|0.4479
71817215|NCT00384059|143137228|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.3|2.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated||2.8|-5.3|
71817216|NCT00384059|143137229|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.68|1.16||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.68|
71899915|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.0123|TWO_SIDED|95.0|0.451|0.908|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.451|0.0123
71899916|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.0147|TWO_SIDED|95.0|0.553|0.937|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.937|0.553|0.0147
71899917|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.718||||0.0071|TWO_SIDED|95.0|0.564|0.914|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.914|0.564|0.0071
71899918|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.058|||<|0.0001|TWO_SIDED|95.0|1.052|1.064|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.064|1.052|<0.0001
71899919|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.014||||0.0019|TWO_SIDED|95.0|1.005|1.023|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.023|1.005|0.0019
71899920|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.701||||0.0083|TWO_SIDED|95.0|0.539|0.913|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.913|0.539|0.0083
71899921|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.174|||<|0.0001|TWO_SIDED|95.0|0.09|0.338|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.338|0.090|<0.0001
71899922|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.057||||0.0008|TWO_SIDED|95.0|1.023|1.091|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.091|1.023|0.0008
71899923|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.638||||0.0255|TWO_SIDED|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.946|0.431|0.0255
71849119|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|226.9|||||TWO_SIDED|95.0|79.81|645.29|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||645.29|79.81|
71849120|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|116.8|||||TWO_SIDED|95.0|54.54|250.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||250.13|54.54|
71899924|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.755||||0.0059|TWO_SIDED|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.922|0.618|0.0059
71899925|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.521||||0.0005|TWO_SIDED|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.236|1.501|0.0005
71899926|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.602||||0.0011|TWO_SIDED|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.627|1.463|0.0011
71817217|NCT00384059|143137230|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.54|1.08||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.54|
71817218|NCT00384059|143137231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.82|1.16||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.82|
71817219|NCT00384059|143137231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.83|1.17||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.83|
71817220|NCT00384059|143137231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.8|1.26||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.26|0.80|
71817221|NCT00384059|143137231|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.23||||||For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated||1.23|0.81|
71817222|NCT00384059|143137232|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.83|1.53||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.53|0.83|
71679409|NCT02045862|142876842|SUPERIORITY||Rate Ratio|0.9|STANDARD_ERROR_OF_MEAN|0.06||0.067|TWO_SIDED|95.0|0.81|1.01|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable||1.01|0.81|0.067
71679410|NCT02045862|142876842|SUPERIORITY||Rate Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.06||0.131||95.0|0.82|1.03|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.||1.03|0.82|0.131
71849121|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|481.0|||||TWO_SIDED|95.0|207.01|1117.69|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1117.69|207.01|
71849122|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|66.5|||||TWO_SIDED|95.0|41.8|105.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||105.75|41.80|
71817223|NCT00384059|143137237|SUPERIORITY_OR_OTHER||Ration|0.85||||||95.0|0.48|1.49||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated||1.49|0.48|
71817224|NCT03661996|143137300|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.063|STANDARD_ERROR_OF_MEAN|1.0216|||TWO_SIDED|95.0|1.019|1.108|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.108|1.019|
71817225|NCT03661996|143137300|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.959|STANDARD_ERROR_OF_MEAN|1.0221|||TWO_SIDED|95.0|0.919|1.001|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.001|0.919|
71817226|NCT03661996|143137300|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|1.013|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.97|1.057|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||1.057|0.970|
71817227|NCT03661996|143137300|NON_INFERIORITY|The treatment regimen is Clinically Acceptable if it is no more than 30% worse than the Breg Cooling Control Group and the lower bound of the 95% CI for Ratio of Geometric LS Means is greater than 0.7.|Ratio of Geometric LS Means|0.931|STANDARD_ERROR_OF_MEAN|1.0219|||TWO_SIDED|95.0|0.892|0.972|||||Parameter dispersion is the Standard Error of the Ratio of Geometric LS Means|Geometric LS means, ratio of geometric LS means, with Breg Cooling as control, and 95% CIs were obtained from an ANCOVA model on the natural log-transformed composite outcome with cooling and injection procedure as the main effect. Baseline K-L grade, baseline BMI category, sex, and reverse-scored and normalized index knee procedure pain were included as covariates. Estimates and CIs on the log scale were exponentiated to obtain ratios of geometric means on the original scale.||0.972|0.892|
71817228|NCT03661996|143137301|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|17.15|STANDARD_ERROR_OF_MEAN|1.396|<|0.0001|TWO_SIDED|95.0|14.4|19.9|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||19.90|14.40|<0.0001
71817229|NCT03661996|143137301|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Mean Difference (Final Values)|20.41|STANDARD_ERROR_OF_MEAN|3.692|<|0.0001|TWO_SIDED|95.0|12.79|28.03|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||28.03|12.79|<0.0001
71817230|NCT03661996|143137301|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.05|STANDARD_ERROR_OF_MEAN|0.819|<|0.0001|TWO_SIDED|95.0|18.44|21.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||21.66|18.44|<0.0001
71817231|NCT03661996|143137301|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|18.4|STANDARD_ERROR_OF_MEAN|1.011|<|0.0001|TWO_SIDED|95.0|16.41|20.38|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||20.38|16.41|<0.0001
71817232|NCT03661996|143137302|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.45|STANDARD_ERROR_OF_MEAN|1.478|<|0.0001|TWO_SIDED|95.0|19.54|25.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.37|19.54|<0.0001
71817233|NCT03661996|143137302|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.9|STANDARD_ERROR_OF_MEAN|4.613|<|0.0001|TWO_SIDED|95.0|14.38|33.42|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||33.42|14.38|<0.0001
71817234|NCT03661996|143137302|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.62|STANDARD_ERROR_OF_MEAN|0.865|<|0.0001|TWO_SIDED|95.0|23.92|27.32|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.32|23.92|<0.0001
71849123|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.6|||||TWO_SIDED|95.0|5.36|13.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||13.94|5.36|
71899927|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.727||||0.0034|TWO_SIDED|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.491|1.198|0.0034
71817235|NCT03661996|143137302|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.053|<|0.0001|TWO_SIDED|95.0|20.03|24.17|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||24.17|20.03|<0.0001
71817236|NCT03661996|143137303|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.1|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|17.6|24.5|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||24.5|17.6|<0.0001
71817237|NCT03661996|143137303|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.3|STANDARD_ERROR_OF_MEAN|6.06||0.0003|TWO_SIDED|95.0|12.7|37.8|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||37.8|12.7|0.0003
71849124|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|78.2|||||TWO_SIDED|95.0|41.38|147.8|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||147.80|41.38|
71899928|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.545||||0.0014|TWO_SIDED|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.792|0.376|0.0014
71899929|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.0042|TWO_SIDED|95.0|0.822|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.822|0.0042
71899930|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.824||||0.0363|TWO_SIDED|95.0|0.687|0.988|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.687|0.0363
71899931|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.842||||0.0033|TWO_SIDED|95.0|0.751|0.944|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.944|0.751|0.0033
71899932|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.477||||0.0006|TWO_SIDED|95.0|1.183|1.844|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.844|1.183|0.0006
71899933|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128||||0.381|TWO_SIDED|95.0|0.862|1.477|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.477|0.862|0.3810
71899934|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.812||||0.0279|TWO_SIDED|95.0|0.674|0.978|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.978|0.674|0.0279
71899935|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|45.894|||<|0.0001|TWO_SIDED|95.0|27.972|75.299|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||75.299|27.972|<0.0001
71899936|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.176|||<|0.0001|TWO_SIDED|95.0|20.129|51.434|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||51.434|20.129|<0.0001
71899937|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.928|||<|0.0001|TWO_SIDED|95.0|4.291|11.188|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.188|4.291|<0.0001
71899938|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.733||||0.0204|TWO_SIDED|95.0|0.564|0.953|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.564|0.0204
71817238|NCT03661996|143137303|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.85|STANDARD_ERROR_OF_MEAN|1.035|<|0.0001|TWO_SIDED|95.0|23.82|27.88|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||27.88|23.82|<0.0001
71817239|NCT03661996|143137303|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|23.34|STANDARD_ERROR_OF_MEAN|1.238|<|0.0001|TWO_SIDED|95.0|20.91|25.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms for pooled site group, baseline K-L grade category, baseline BMI category (\<30 kg/m2, ≥30 kg/m2), sex, study visit, and baseline KOOS subscale score as covariates. Study visit was included in the model as a categorical variable.||25.78|20.91|<0.0001
71817240|NCT03661996|143137304|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|20.86|STANDARD_ERROR_OF_MEAN|1.481|<|0.0001|TWO_SIDED|95.0|17.94|23.78|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.78|17.94|<0.0001
71817241|NCT03661996|143137304|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.66|STANDARD_ERROR_OF_MEAN|4.568|<|0.0001|TWO_SIDED|95.0|16.24|35.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||35.09|16.24|<0.0001
71817242|NCT03661996|143137304|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.57|STANDARD_ERROR_OF_MEAN|0.861|<|0.0001|TWO_SIDED|95.0|23.88|27.26|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.26|23.88|<0.0001
71817243|NCT03661996|143137304|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.69|STANDARD_ERROR_OF_MEAN|0.853|<|0.0001|TWO_SIDED|95.0|24.02|27.37|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.37|24.02|<0.0001
71817244|NCT03661996|143137305|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|25.17|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|95.0|20.74|29.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.60|20.74|<0.0001
71679411|NCT02045862|142876843|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.35||0.055|TWO_SIDED|95.0|-1.34|0.01|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.01|-1.34|0.055
71817245|NCT03661996|143137305|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|33.11|STANDARD_ERROR_OF_MEAN|5.795|<|0.0001|TWO_SIDED|95.0|21.15|45.07|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||45.07|21.15|<0.0001
71817246|NCT03661996|143137305|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|27.8|STANDARD_ERROR_OF_MEAN|1.233|<|0.0001|TWO_SIDED|95.0|25.38|30.23|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||30.23|25.38|<0.0001
71817247|NCT03661996|143137305|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|24.8|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|21.66|27.94|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||27.94|21.66|<0.0001
71817248|NCT03661996|143137306|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|22.1|STANDARD_ERROR_OF_MEAN|1.898|<|0.0001|TWO_SIDED|95.0|18.37|25.84|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||25.84|18.37|<0.0001
71817249|NCT03661996|143137306|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|16.75|STANDARD_ERROR_OF_MEAN|6.255|<|0.0001|TWO_SIDED|95.0|3.84|29.66|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||29.66|3.84|<0.0001
71817250|NCT03661996|143137306|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|21.52|STANDARD_ERROR_OF_MEAN|1.062|<|0.0001|TWO_SIDED|95.0|19.43|23.6|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||23.60|19.43|<0.0001
71817251|NCT03661996|143137306|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|19.4|STANDARD_ERROR_OF_MEAN|1.365|<|0.0001|TWO_SIDED|95.0|16.72|22.09|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The KOOS subscale scores are derived and normalized. Higher scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline subscale score as covariates.||22.09|16.72|<0.0001
71817252|NCT03661996|143137307|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.48|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-3.86|-3.1|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.10|-3.86|<0.0001
71817253|NCT03661996|143137307|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.52|STANDARD_ERROR_OF_MEAN|0.416|<|0.0001|TWO_SIDED|95.0|-4.38|-2.67|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-2.67|-4.38|<0.0001
71849125|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|438.1|||||TWO_SIDED|95.0|169.52|1132.43|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1132.43|169.52|
71849126|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|80.0|||||TWO_SIDED|95.0|23.28|274.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||274.82|23.28|
71849127|NCT00824850|143211888|SUPERIORITY_OR_OTHER||geometric mean fold rise|61.5|||||TWO_SIDED|95.0|28.73|131.76|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.76|28.73|
71849128|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|281.7|||||TWO_SIDED|95.0|76.65|1035.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1035.49|76.65|
71817254|NCT03661996|143137307|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-4.02|STANDARD_ERROR_OF_MEAN|0.118|<|0.0001|TWO_SIDED|95.0|-4.25|-3.79|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.79|-4.25|<0.0001
71817255|NCT03661996|143137307|SUPERIORITY|A within-group analysis of change at Week 8 from baseline.|Least Squares Mean Change From Baseline|-3.72|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-3.96|-3.48|||Mixed Models Analysis|LS means, 95% CIs, and P values were obtained from a mixed model for repeated measures (MMRM)||Results are summarized by subject type and the injected knee. The NPRS was collected during the last study visit. Lower scores indicate improvement. Model terms included pooled site group, baseline K-L grade category, baseline BMI category, sex, study visit, and baseline pain score as covariates.||-3.48|-3.96|<0.0001
71817256|NCT03029247|143137321|SUPERIORITY||LS Mean Difference|-0.17||||0.9694|TWO_SIDED|95.0|-8.8|8.47||p-value for the difference between treatment groups were presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% confidence interval (CI) has been presented.|||8.47|-8.80|0.9694
71817257|NCT03029247|143137322|SUPERIORITY||LS Mean Difference|-1.32||||0.7745|TWO_SIDED|95.0|-10.46|7.83||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of SBP and its corresponding 95% CI has been presented.|||7.83|-10.46|0.7745
71817258|NCT03029247|143137322|SUPERIORITY||LS Mean Difference|-1.95||||0.291|TWO_SIDED|95.0|-5.62|1.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||1.71|-5.62|0.2910
71817259|NCT03029247|143137322|SUPERIORITY||LS Mean Difference|-2.4||||0.4611|TWO_SIDED|95.0|-8.88|4.07||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||4.07|-8.88|0.4611
71817260|NCT03029247|143137323|SUPERIORITY||LS Mean Difference|-2.95||||0.1648|TWO_SIDED|95.0|-7.14|1.24||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||1.24|-7.14|0.1648
71817261|NCT03029247|143137324|SUPERIORITY||LS Mean Difference|-13.42||||0.9142|TWO_SIDED|95.0|-261.75|234.92||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||234.92|-261.75|0.9142
71849129|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|7.6|||||TWO_SIDED|95.0|3.47|16.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||16.75|3.47|
71849130|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|151.4|||||TWO_SIDED|95.0|42.01|545.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||545.84|42.01|
71849131|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|23.7|||||TWO_SIDED|95.0|8.67|64.54|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||64.54|8.67|
71849132|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|102.1|||||TWO_SIDED|95.0|32.0|325.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||325.40|32.00|
71849133|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|31.1|||||TWO_SIDED|95.0|12.71|76.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||76.13|12.71|
71849134|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|18.7|||||TWO_SIDED|95.0|6.82|51.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||51.39|6.82|
71849135|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|64.4|||||TWO_SIDED|95.0|37.33|111.18|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||111.18|37.33|
71817262|NCT03029247|143137324|SUPERIORITY||LS Mean Difference|-71.7||||0.2266|TWO_SIDED|95.0|-189.21|45.8||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||45.80|-189.21|0.2266
71817263|NCT03029247|143137324|SUPERIORITY||LS Mean Difference|-54.24||||0.5246|TWO_SIDED|95.0|-223.99|115.51||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||115.51|-223.99|0.5246
71817264|NCT03029247|143137325|SUPERIORITY||LS Mean Difference|-74.4||||0.1563|TWO_SIDED|95.0|-178.15|29.34||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||29.34|-178.15|0.1563
71817265|NCT03029247|143137326|SUPERIORITY||LS Mean Difference|-2.06||||0.3247|TWO_SIDED|95.0|-6.23|2.1||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of DBP and its corresponding 95% CI has been presented.|||2.10|-6.23|0.3247
71817266|NCT03029247|143137326|SUPERIORITY||LS Mean Difference|-2.51||||0.4235|TWO_SIDED|95.0|-8.76|3.74||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) of MAP and its corresponding 95% CI has been presented.|||3.74|-8.76|0.4235
71817267|NCT03029247|143137327|SUPERIORITY||LS Mean Difference|-0.13||||0.9353|TWO_SIDED|95.0|-3.41|3.14||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) and its corresponding 95% CI has been presented.|||3.14|-3.41|0.9353
71817268|NCT03029247|143137328|SUPERIORITY||LS Mean Difference|-144.97||||0.2573|TWO_SIDED|95.0|-399.71|109.76||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of SBP and its corresponding 95% CI has been presented.|||109.76|-399.71|0.2573
71817269|NCT03029247|143137328|SUPERIORITY||LS Mean Difference|-117.49||||0.045|TWO_SIDED|95.0|-232.26|-2.72||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of DBP and its corresponding 95% CI has been presented.|||-2.72|-232.26|0.0450
71817270|NCT03029247|143137328|SUPERIORITY||LS Mean Difference|-131.94||||0.1341|TWO_SIDED|95.0|-306.24|42.36||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of MAP and its corresponding 95% CI has been presented.|||42.36|-306.24|0.1341
71849136|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|11.1|||||TWO_SIDED|95.0|6.64|18.52|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||18.52|6.64|
71849137|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|41.2|||||TWO_SIDED|95.0|23.09|73.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||73.48|23.09|
71849138|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|479.6|||||TWO_SIDED|95.0|171.63|1339.96|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1339.96|171.63|
71849139|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|76.4|||||TWO_SIDED|95.0|21.63|270.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||270.02|21.63|
71817271|NCT03029247|143137329|SUPERIORITY||LS Mean Difference|-97.67||||0.1119|TWO_SIDED|95.0|-219.05|23.71||p-value for the difference between treatment groups was presented from ANCOVA model for the superiority assessment.|ANCOVA||LS Mean treatment difference (daprodustat minus recombinant human erythropoietin) for AUEC of HR and its corresponding 95% CI has been presented.|||23.71|-219.05|0.1119
71817272|NCT00584701|143137426|SUPERIORITY_OR_OTHER||Dfiference in exon expression|1.5|||<|0.001||||||"Expression difference \>\|1.5\| with p-value adjusted for multiple comparisons."|ANCOVA|Between-group gene expression profiles compared between high versus low responders, controlling for age, gender and batch.||||||<.001
71817273|NCT01928225|143137469|SUPERIORITY||Risk Ratio (RR)|1.18||||0.29|TWO_SIDED|95.0|0.87|1.6||\<0.05 was considered statistically significant.|Chi-squared|||||1.6|.87|.29
71817274|NCT01928225|143137470|SUPERIORITY||Risk Ratio (RR)|1.26||||0.22|TWO_SIDED|95.0|0.85|1.95|||Chi-squared|||||1.95|.85|.22
71817275|NCT04250337|143137471|SUPERIORITY||Risk Difference (RD)|18.3||||0.011|TWO_SIDED|95.0|5.1|31.5|||Cochran-Mantel-Haenszel|||||31.5|5.1|0.011
71817276|NCT04250337|143137472|SUPERIORITY||Risk Difference (RD)|26.4|||<|0.001|TWO_SIDED|95.0|12.1|40.8|||Cochran-Mantel-Haenszel|||||40.8|12.1|<.001
71817277|NCT04250337|143137473|SUPERIORITY||Risk Difference (RD)|18.9||||0.008|TWO_SIDED|95.0|6.1|31.7|||Cochran-Mantel-Haenszel|||||31.7|6.1|0.008
71817278|NCT04250337|143137474|SUPERIORITY||LS Mean Difference (Final Values)|-15.21|STANDARD_ERROR_OF_MEAN|6.373||0.017263|TWO_SIDED|95.0|-27.7|-2.7|||ANCOVA|||||-2.7|-27.7|0.017263
71817279|NCT04250337|143137475|SUPERIORITY||Risk Difference (RD)|19.2||||0.017|TWO_SIDED|95.0|4.3|34.1|||Cochran-Mantel-Haenszel|||||34.1|4.3|0.017
71817280|NCT04250337|143137476|SUPERIORITY||Risk Difference (RD)|21.6||||0.007|TWO_SIDED|95.0|7.1|36.1|||Cochran-Mantel-Haenszel|||||36.1|7.1|0.007
71817281|NCT04250337|143137477|SUPERIORITY||LS Mean Difference (Final Values)|-23.64|STANDARD_ERROR_OF_MEAN|5.074||3e-06|TWO_SIDED|95.0|-33.6|-13.7|||ANCOVA|||||-13.7|-33.6|0.000003
71817282|NCT04250337|143137478|SUPERIORITY||LS Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|2.428|<|0.001|TWO_SIDED|95.0|-17.07|-7.49|||Mixed Models Analysis|||||-7.49|-17.07|<0.001
71849140|NCT00824850|143211889|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.7|||||TWO_SIDED|95.0|7.61|41.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||41.08|7.61|
71817283|NCT04250337|143137479|SUPERIORITY||Risk Difference (RD)|3.5||||0.454|TWO_SIDED|95.0|-4.9|11.8|||Cochran-Mantel-Haenszel|||||11.8|-4.9|0.454
71817284|NCT04250337|143137480|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-20.14|STANDARD_ERROR_OF_MEAN|12.81||0.117607|TWO_SIDED|95.0|-45.4|5.1|||ANCOVA|||||5.1|-45.4|0.117607
71817285|NCT04250337|143137481|SUPERIORITY||Markov Chain Monte Carlo (MCMC)|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.025293|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||-0.0|-0.6|0.025293
71817286|NCT04250337|143137482|SUPERIORITY||Risk Difference (RD)|14.2||||0.022|TWO_SIDED|95.0|3.8|24.7|||Cochran-Mantel-Haenszel|||||24.7|3.8|0.022
71817287|NCT04250337|143137483|SUPERIORITY||Risk Difference (RD)|1.2||||0.764|TWO_SIDED|95.0|-7.3|9.7|||Cochran-Mantel-Haenszel|||||9.7|-7.3|0.764
71817288|NCT04250337|143137484|SUPERIORITY||Risk Difference (RD)|1.9||||0.498|TWO_SIDED|95.0|-2.9|6.7|||Cochran-Mantel-Haenszel|||||6.7|-2.9|0.498
71817289|NCT04250337|143137485|SUPERIORITY||Risk Difference (RD)|15.6||||0.014|TWO_SIDED|95.0|5.3|25.9|||Cochran-Mantel-Haenszel|||||25.9|5.3|0.014
71817290|NCT04250337|143137486|SUPERIORITY||Risk Difference (RD)|1.1||||0.818|TWO_SIDED|95.0|-8.0|10.2|||Cochran-Mantel-Haenszel|||||10.2|-8.0|0.818
71817291|NCT04250337|143137487|SUPERIORITY||Risk Difference (RD)|2.0||||0.499|TWO_SIDED|95.0|-3.1|7.1|||Cochran-Mantel-Haenszel|||||7.1|-3.1|0.499
71817292|NCT04250337|143137488|SUPERIORITY||LS Mean Difference (Final Values)|7.29|STANDARD_ERROR_OF_MEAN|5.104||0.155|TWO_SIDED|95.0|-2.78|17.36|||Mixed Models Analysis|||||17.36|-2.78|0.155
71817293|NCT04250337|143137490|SUPERIORITY||LS Mean Difference (Final Values)|-17.69|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-26.37|-9.01|||ANCOVA|||||-9.01|-26.37|<0.001
71817294|NCT04250337|143137491|SUPERIORITY||LS Mean Difference (Final Values)|-3.33|STANDARD_ERROR_OF_MEAN|1.014||0.001031|TWO_SIDED|95.0|-5.3|-1.3|||ANCOVA|||||-1.3|-5.3|0.001031
71817295|NCT04250337|143137492|SUPERIORITY||Risk Difference (RD)|17.2||||0.036|TWO_SIDED|95.0|0.1|34.3|||Cochran-Mantel-Haenszel|||||34.3|0.1|0.036
71817296|NCT04250337|143137493|SUPERIORITY||LS Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.025|<|0.001|TWO_SIDED|95.0|0.06|0.16|||ANCOVA|||Health State Index UK||0.16|0.06|<0.001
71817297|NCT04250337|143137493|SUPERIORITY||LS Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.018|<|0.001|TWO_SIDED|95.0|0.04|0.11|||ANCOVA|||Health State Index US||0.11|0.04|<0.001
71817298|NCT04250337|143137494|SUPERIORITY||LS Mean Difference (Final Values)|3.62|STANDARD_ERROR_OF_MEAN|2.386||0.131|TWO_SIDED|95.0|-1.08|8.32|||ANCOVA|||||8.32|-1.08|0.131
71817299|NCT04250337|143137495|SUPERIORITY||LS Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|1.145|<|0.001|TWO_SIDED|95.0|-6.26|-1.74|||Mixed Models Analysis|||||-1.74|-6.26|<0.001
71817300|NCT04250337|143137496|SUPERIORITY||LS Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.407||0.571|TWO_SIDED|95.0|-3.58|1.98|||ANCOVA|||||1.98|-3.58|0.571
71817301|NCT04250337|143137497|SUPERIORITY||LS Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|1.127||0.882|TWO_SIDED|95.0|-2.4|2.06|||ANCOVA|||||2.06|-2.40|0.882
71817302|NCT04250337|143137498|SUPERIORITY||LS Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.48||0.171|TWO_SIDED|95.0|-1.56|8.48|||ANCOVA|||||8.48|-1.56|0.171
71817303|NCT04250337|143137499|SUPERIORITY||LS Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.697||0.109|TWO_SIDED|95.0|-1.03|9.89|||ANCOVA|||||9.89|-1.03|0.109
71817304|NCT04250337|143137500|SUPERIORITY||LS Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.116||0.922|TWO_SIDED|95.0|-0.22|0.24|||ANCOVA|||||0.24|-0.22|0.922
71817305|NCT04250337|143137501|SUPERIORITY||LS Mean Difference (Final Values)|-4.62|STANDARD_ERROR_OF_MEAN|1.271||0.001|TWO_SIDED|95.0|-7.22|-2.03|||Mixed Models Analysis|||||-2.03|-7.22|0.001
71817306|NCT00365378|143137509|SUPERIORITY_OR_OTHER||Vaccine Efficacy|94.3||||||95.0|87.8|97.7|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.7|87.8|
71817307|NCT00365378|143137510|SUPERIORITY_OR_OTHER||Vaccine Efficacy|100.0||||||95.0|84.0|100.0|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||100.0|84.0|
71817308|NCT02006121|143137558|SUPERIORITY|||||||0.0047|||||||Mixed Models Analysis|||||||0.0047
71817309|NCT02006121|143137559|SUPERIORITY|||||||0.0022|||||||Mixed Models Analysis|||||||0.0022
71817310|NCT02006121|143137560|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71817311|NCT02006121|143137561|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
71817312|NCT02006121|143137562|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71817313|NCT02223065|143137589|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.975||||0.495|TWO_SIDED|90.0|0.915|1.038|||ANOVA|||||1.038|0.915|0.4950
71817314|NCT02223065|143137590|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.993||||0.865|TWO_SIDED|90.0|0.932|1.06|||ANOVA|||||1.060|0.932|0.8650
71817315|NCT02223065|143137591|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.022||||0.2344|TWO_SIDED|90.0|0.991|1.054|||ANOVA|||||1.054|0.991|0.2344
71817316|NCT02223065|143137592|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.016||||0.2458|TWO_SIDED|90.0|0.993|1.038|||ANOVA|||||1.038|0.993|0.2458
71817317|NCT02223065|143137593|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.024||||0.1947|TWO_SIDED|90.0|0.993|1.056|||ANOVA|||||1.056|0.993|0.1947
71817318|NCT02223065|143137594|NON_INFERIORITY_OR_EQUIVALENCE|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.013||||0.3191|TWO_SIDED|90.0|0.992|1.034|||ANOVA|||||1.034|0.992|0.3191
71817319|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.4|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.4
71817320|NCT01614847|143137597|EQUIVALENCE|two-tailed, alpha = 0.05||||||0.109|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.109
71817321|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.779|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.779
71817322|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.262|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.262
71817323|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.150
71849141|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|170.2|||||TWO_SIDED|95.0|22.24|1301.79|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||1301.79|22.24|
71849142|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|17.8|||||TWO_SIDED|95.0|5.27|59.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||59.91|5.27|
71849143|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|67.8|||||TWO_SIDED|95.0|18.45|249.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||249.02|18.45|
71849144|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|22.2|||||TWO_SIDED|95.0|7.94|61.88|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||61.88|7.94|
71817324|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.726|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.726
71817325|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.055|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.055
71817326|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
71817327|NCT01614847|143137597|EQUIVALENCE|Alpha = 0.05||||||0.844|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.844
71817328|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.945||||||df=7|Wilcoxon (Mann-Whitney)|||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.945
71817329|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383||||||Alpha = 0.05|Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.383
71817330|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.383|||||||Wilcoxon (Mann-Whitney)|df=7||Mean change in osmolarity from baseline. H0: No change (e.g. mean change = 0) H1: Significant change (mean change ≠ 0)||||0.383
71817331|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.672|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.672
71817332|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.107|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)||||0.107
71817333|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.64|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.64
71817334|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.04|||||||Wilcoxon (Mann-Whitney)|df=14||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.040
71899939|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.087|0.331|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.331|0.087|<0.0001
71899940|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.806||||0.001|TWO_SIDED|95.0|1.514|5.201|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.201|1.514|0.0010
71899941|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.0459|TWO_SIDED|95.0|0.443|0.993|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.993|0.443|0.0459
71679412|NCT02045862|142876843|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.35||0.048|TWO_SIDED|95.0|-1.39|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-1.39|0.048
71899942|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.758||||0.0087|TWO_SIDED|95.0|0.616|0.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.932|0.616|0.0087
71899943|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.054||||0.0064|TWO_SIDED|95.0|1.224|3.447|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.447|1.224|0.0064
71899944|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.931||||0.0271|TWO_SIDED|95.0|1.077|3.461|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.461|1.077|0.0271
71899945|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.738||||0.0039|TWO_SIDED|95.0|1.194|2.528|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|1.194|0.0039
71899946|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.565||||0.0035|TWO_SIDED|95.0|0.386|0.829|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.829|0.386|0.0035
71899947|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.533||||0.0071|TWO_SIDED|95.0|1.593|19.219|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||19.219|1.593|0.0071
71899948|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.964||||0.3042|TWO_SIDED|95.0|0.542|7.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||7.114|0.542|0.3042
71899949|NCT01070550|143322211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.726||||0.41|TWO_SIDED|95.0|0.471|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.471|0.4100
71899950|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379|||<|0.0001|TWO_SIDED|95.0|1.236|1.538|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.538|1.236|<0.0001
71817335|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.2|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.20
71817336|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df-=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.150
71817337|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.73|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.730
71849145|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|205.5|||||TWO_SIDED|95.0|70.04|602.78|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||602.78|70.04|
71849146|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|90.5|||||TWO_SIDED|95.0|40.28|203.27|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||203.27|40.28|
71849147|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|91.7|||||TWO_SIDED|95.0|36.25|232.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||232.13|36.25|
71849148|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|75.6|||||TWO_SIDED|95.0|47.32|120.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||120.91|47.32|
71849149|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|8.7|||||TWO_SIDED|95.0|5.21|14.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||14.40|5.21|
71849150|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|60.0|||||TWO_SIDED|95.0|31.06|115.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||115.92|31.06|
71849151|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|269.8|||||TWO_SIDED|95.0|105.09|692.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||692.60|105.09|
71849152|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|37.7|||||TWO_SIDED|95.0|10.85|131.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||131.09|10.85|
71849153|NCT00824850|143211890|SUPERIORITY_OR_OTHER||geometric mean fold rise|44.8|||||TWO_SIDED|95.0|21.31|94.01|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.||94.01|21.31|
71849154|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.97|||||TWO_SIDED|95.0|1.31|2.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.95|1.31|
71899951|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.033||||0.0251|TWO_SIDED|95.0|1.004|1.063|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|1.004|0.0251
71899952|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.585|||<|0.0001|TWO_SIDED|95.0|1.358|1.849|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.849|1.358|<0.0001
71899953|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.501||||0.0317|TWO_SIDED|95.0|1.036|2.174|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.174|1.036|0.0317
71899954|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.493||||0.0129|TWO_SIDED|95.0|1.089|2.048|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.048|1.089|0.0129
71899955|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.616||||0.0128|TWO_SIDED|95.0|1.107|2.357|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.357|1.107|0.0128
71817338|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
71817339|NCT01614847|143137597|EQUIVALENCE|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B||||0.89
71817340|NCT00249496|143137598|SUPERIORITY||Odds Ratio (OR)|3.73||||0.004|TWO_SIDED|95.0|1.6|8.69|||General Estimating Equation (GEE)|||||8.69|1.60|.004
71817341|NCT00249496|143137600|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.57|TWO_SIDED|95.0|0.26|2.43|||General Estimating Equation (GEE)|||||2.43|0.26|=0.57
71849155|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.95|||||TWO_SIDED|95.0|1.78|4.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.90|1.78|
71849156|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.85|||||TWO_SIDED|95.0|1.25|2.75|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.75|1.25|
71849157|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.24|||||TWO_SIDED|95.0|1.11|4.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.53|1.11|
71849158|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.63|||||TWO_SIDED|95.0|0.38|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.05|0.38|
71849159|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.5|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.50|
71849160|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.83|||||TWO_SIDED|95.0|0.48|1.43|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.43|0.48|
71849161|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.7|||||TWO_SIDED|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.00|0.96|
71849162|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.25|||||TWO_SIDED|95.0|0.79|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.96|0.79|
71849163|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.54|1.52|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.52|0.54|
71849164|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.81|||||TWO_SIDED|95.0|0.98|3.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.34|0.98|
71817342|NCT00249496|143137602|SUPERIORITY||Odds Ratio (OR)|0.0||||0.046|TWO_SIDED|95.0|0.0|0.0|||General Estimating Equation (GEE)||The Odds Ratio and Confidence Intervals could not be calculated because one of the groups was at 0.|||0|0|0.046
71817343|NCT02693834|143137603|OTHER|Paired t test||||||0.293|||||||t-test, 2 sided|||In order to test the difference in gait endurance,between the two AFO conditions at baseline, a paired t-test was analyzed||||.293
71817344|NCT02693834|143137604|OTHER|Repeated measures ANOVA||||||0.077||||||The above value was the interaction between the type of AFO and practice time.|repeated measures ANOVA|||A repeated measures ANOVA was calculated to find the differences in gait endurance between the type of AFO and practice time.||||0.077
71817345|NCT02693834|143137604|OTHER|Repeated measures ANOVA||||||0.046||||||main effect of the type of AFO: F(1, 19) = 4.58, ηp2= .194|repeated measures ANOVA|||The main effect of type of AFO||||.046
71817346|NCT02693834|143137604|OTHER|Repeated measures ANOVA|||||<|0.001||||||main effect of practice: F(1, 19) = 43.94, ηp2 = .698|repeated measures ANOVA|||Main effect of practice||||<.001
71817347|NCT02693834|143137605|OTHER|paired t test||||||0.688|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for self selected velocity||||.688
71817348|NCT02693834|143137605|OTHER|repeated measures MANOVA||||||0.397||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at the self selected velocity F(1, 19)= 0.75, ηp2 = .038|repeated measures MANOVA|||The significance of differences in gait symmetry at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.397
71817349|NCT02693834|143137605|OTHER|A repeated measures MANOVA||||||0.95||||||Main effect of AFO on gait symmetry at SSV: F(1, 19) = 0.004, ηp2 =.00|Repeated measures MANOVA|||Main effect of AFO on gait symmetry was analyzed at self selected velocity||||.950
71817350|NCT02693834|143137605|OTHER|Repeated measures MANOVA||||||0.111||||||The main effect of practice on gait symmetry at self selected velocity F(1, 19) = 2.79, ηp2 = .128|repeated measures MANOVA|||Main effect of practice on gait symmetry at Self selected velocity||||.111
71817351|NCT02693834|143137605|OTHER|||||||0.26|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for fast paced velocity||||.260
71817352|NCT02693834|143137605|OTHER|repeated measures MANOVA||||||0.113||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at fast paced velocity FPV F(1, 19) = 2.76,, ηp2 = .127|repeated measures MANOVA|||The significance of differences in gait symmetry at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA||||.113
71817353|NCT02693834|143137605|OTHER|Repeated measures MANOVA||||||0.918||||||The main effect of AFO on gait symmetry at fast paced velocity: F(1, 19) = 0.01, ηp2 = 0.001|repeated measures MANOVA|||The main effect of AFO on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.918
71817354|NCT02693834|143137605|OTHER|Repeated measures MANOVA||||||0.077||||||The main effect of practice on gait symmetry at fast paced velocity: F(1, 19) = 3.50, ηp2 = .155|repeated measures MANOVA|||The main effect of practice on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA||||.077
71899956|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.046||||0.7809|TWO_SIDED|95.0|0.763|1.432|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\^9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.432|0.763|0.7809
71899957|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969|||<|0.0001|TWO_SIDED|95.0|0.962|0.976|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.976|0.962|<0.0001
71899958|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.298||||0.0189|TWO_SIDED|95.0|1.273|14.512|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.512|1.273|0.0189
71899959|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
71899960|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
71899961|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
71899962|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
71899963|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.677||||0.0007|TWO_SIDED|95.0|1.243|2.263|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.263|1.243|0.0007
71817355|NCT02693834|143137606|OTHER|A repeated measures MANOVA||||||0.209||||||The above p value is for the interaction effects between the type of AFO and practice time at self selected velocity: F(1, 19) = 1.69, ηp2 = .082|Repeated measures MANOVA|||The significance of differences in gait velocity at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.209
71817356|NCT02693834|143137606|OTHER|Repeated measures MANOVA||||||0.32||||||Main effect of AFO on gait velocity at self selected velocity: F(1, 19) = 1.05, ηp2 = .05|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed at self selected velocity||||.32
71817357|NCT02693834|143137606|OTHER|Repeated measures MANOVA||||||0.001||||||Main effect of practice on gait velocity at self selected velocity:F(1, 19) = 14.38, ηp2 = .431|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed at self selected velocity||||.001
71817358|NCT02693834|143137606|OTHER|repeated measures MANOVA||||||0.28||||||The above p value is for the interaction effects between the type of AFO and practice time at fast paced velocity: F( 1, 19) = 1.24, ηp2 = .61|repeated measures MANOVA|||The significance of differences in gait velocity at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.||||.280
71817359|NCT02693834|143137606|OTHER|repeated measures MANOVA||||||0.072||||||Main effect of AFO on gait velocity was analyzed at self selected velocity:FPV F(1, 19) = 3.63, ηp2 =.16|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed for self selected velocity||||.072
71817360|NCT02693834|143137606|OTHER|Repeated measures MANOVA|||||<|0.001||||||Main effect of Practice on gait velocity for fast paced velocity: F(1, 19) = 23.73, ηp2 = .555|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed for fast paced velocity||||<.001
71817361|NCT00152971|143137614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|5.8||||0.0234||95.0|0.8|10.8||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.8|0.8|0.0234
71817362|NCT00152971|143137614|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|8.4||||0.0009||95.0|3.4|13.3||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.3|3.4|0.0009
71817363|NCT00152971|143137615|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.2||||0.2139||95.0|-0.7|3.0|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.0|-0.7|0.2139
71849165|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.72|||||TWO_SIDED|95.0|1.05|2.83|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.83|1.05|
71849166|NCT00824850|143211891|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.67|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.67|
71817364|NCT00152971|143137615|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.8||||0.3628||95.0|-0.9|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.9|0.3628
71849167|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|2.18|||||TWO_SIDED|95.0|1.26|3.79|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.79|1.26|
71849168|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|3.13|||||TWO_SIDED|95.0|1.84|5.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||5.32|1.84|
71817365|NCT00152971|143137616|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.9||||0.2309||95.0|-0.6|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.5|-0.6|0.2309
71817366|NCT00152971|143137616|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|1.5||||0.0602||95.0|-0.1|3.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||3.2|-0.1|0.0602
71817367|NCT00152971|143137617|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|5.9||||0.0194||95.0|1.0|10.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||10.9|1.0|0.0194
71817368|NCT00152971|143137617|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|8.9||||0.0004||95.0|4.0|13.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||13.9|4.0|0.0004
71817369|NCT00152971|143137618|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.5774
71817370|NCT00152971|143137618|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71817371|NCT00152971|143137619|SUPERIORITY_OR_OTHER|||||||0.7724||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.7724
71817372|NCT00152971|143137619|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0308
71817373|NCT00152971|143137620|SUPERIORITY_OR_OTHER|||||||0.4968||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.4968
71817374|NCT00152971|143137620|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71817375|NCT00152971|143137622|SUPERIORITY_OR_OTHER|||||||0.1416||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1416
71817376|NCT00152971|143137622|SUPERIORITY_OR_OTHER|||||||0.0942||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0942
71817377|NCT03959592|143137659|OTHER|||||||0.14|||||||Generalized Estimating Equations|||||||0.14
71817378|NCT03959592|143137660|OTHER|||||||0.423|||||||Generalized Estimating Equations|||||||0.423
71817379|NCT03959592|143137663|OTHER|||||||0.985|||||||Generalized Estimating Equations|||||||0.985
71817380|NCT03959592|143137664|OTHER|||||||0.545|||||||Generalized Estimating Equations|||||||0.545
71817381|NCT02301156|143137709|SUPERIORITY|||||||0.0463|||||||Cochran-Mantel-Haenszel|P-value was estimated by Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata prior lines of therapy.||||||0.0463
71817382|NCT02301156|143137710|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|P-value was estimated by CMH test stratified by the randomization strata prior lines of therapy.||||||0.0159
71817383|NCT02301156|143137711|SUPERIORITY||Rate Difference|35.64|||<|0.0001|TWO_SIDED|95.0|21.39|49.88|||Cochran-Mantel-Haenszel|P-value was estimated using CMH test stratified by the randomization strata prior lines of therapy.|95% Confidence Interval (CI) was estimated using Clopper-Pearson method based on the binomial distribution.|||49.88|21.39|<0.0001
71817384|NCT02301156|143137712|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.0961|TWO_SIDED|95.0|0.295|1.113|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.113|0.295|0.0961
71817385|NCT02301156|143137713|SUPERIORITY||Hazard Ratio (HR)|0.569||||0.1486|TWO_SIDED|95.0|0.263|1.234|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||1.234|0.263|0.1486
71817386|NCT02301156|143137714|SUPERIORITY||Hazard Ratio (HR)|2.163||||0.0004|TWO_SIDED|95.0|1.399|3.344|||Log Rank|P-value was estimated by stratified log rank test and the stratification was based on the randomization strata prior lines of therapy.|Stratified Hazard Ratio and 95% CI were estimated using Cox proportion hazard model and the stratification was based on the randomization strata prior lines of therapy.|||3.344|1.399|0.0004
71817387|NCT02306122|143137718|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.034|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
71817388|NCT02306122|143137718|SUPERIORITY||Risk Difference (RD)|-0.015|STANDARD_ERROR_OF_MEAN|0.041|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
71817389|NCT02306122|143137718|SUPERIORITY||Risk Difference (RD)|0.012|STANDARD_ERROR_OF_MEAN|0.029|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is control arm|||||<0.01
71817390|NCT02306122|143137719|SUPERIORITY||Mean Difference (Final Values)|-0.128|STANDARD_ERROR_OF_MEAN|2.523|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
71817391|NCT02306122|143137719|SUPERIORITY||Mean Difference (Final Values)|-1.582|STANDARD_ERROR_OF_MEAN|2.997|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
71817392|NCT02306122|143137719|SUPERIORITY||Mean Difference (Final Values)|0.308|STANDARD_ERROR_OF_MEAN|2.38|<|0.01|TWO_SIDED||||||Regression, Linear||Comparator is the control arm|||||<0.01
71817393|NCT02306122|143137720|SUPERIORITY||Risk Difference (RD)|-0.043|STANDARD_ERROR_OF_MEAN|0.068|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
71817394|NCT02306122|143137720|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.063|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the information arm|||||<0.01
71817395|NCT02306122|143137721|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.071|<|0.01|TWO_SIDED||||||Regression, Logistic||Comparator is the choice arm|||||<0.01
71817396|NCT01103960|143137754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1881|STANDARD_ERROR_OF_MEAN|0.803||0.007||95.0|0.6082|3.7681||This was the first step in the closed testing procedure of multiple endpoints. The p-value was \<0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.|ANCOVA|||A5 minus T80/A5||3.7681|0.6082|0.007
71817397|NCT01103960|143137755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9195|STANDARD_ERROR_OF_MEAN|0.9015||0.034||95.0|0.1443|3.6947||This was the second step in the closed testing procedure of multiple endpoints. The p-value was again \<0.05 so this test was also considered confirmatory.|ANCOVA|||A5 minus T80/A5||3.6947|0.1443|0.034
71817398|NCT01103960|143137756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4879|STANDARD_ERROR_OF_MEAN|1.1217|<|0.001||95.0|2.2807|6.695|||ANCOVA|||A5 minus T80/A5||6.6950|2.2807|<0.001
71817399|NCT02875834|143137765|OTHER||Mean Difference (Final Values)|0.904|||<|0.001|TWO_SIDED|95.0|0.876|0.933|||Mixed Models Analysis|||Results derived from a mixed effects model of log-transformed S-K levels. Fixed effects are: treatment group; visit; treatment-by-visit interaction; baseline S-K values (OLP and RTP); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses. Patient is a random effect. p-values given are for differences of LSMEANS. The back-transformation is to the original scale of the S-K measurement.||0.933|0.876|<0.001
71817400|NCT02875834|143137765|OTHER||Mean Difference (Final Values)|0.823|||<|0.001|TWO_SIDED|95.0|0.797|0.85|||Mixed Models Analysis|||||0.850|0.797|<0.001
71817401|NCT02875834|143137770|OTHER||Odds Ratio (OR)|6.3436|||<|0.001|TWO_SIDED|95.0|2.6866|14.9782|||Regression, Logistic|||Treatment group comparisons were made using a logistic regression model containing the following covariates: treatment group; both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase); baseline eGFR (during 48-hour open-label initial phase); age category (\<55, 55-64, \>=65 years); country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||14.9782|2.6866|<0.001
71849169|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.68|||||TWO_SIDED|95.0|1.13|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.51|1.13|
71849170|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.96|||||TWO_SIDED|95.0|0.95|4.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||4.07|0.95|
71849171|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|0.9|||||TWO_SIDED|95.0|0.51|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.56|0.51|
71849172|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.58|||||TWO_SIDED|95.0|0.93|2.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.66|0.93|
71849173|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.62|||||TWO_SIDED|95.0|0.97|2.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.73|0.97|
71849174|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.41|||||TWO_SIDED|95.0|0.83|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.39|0.83|
71817402|NCT02875834|143137770|OTHER||Odds Ratio (OR)|18.1876|||<|0.001|TWO_SIDED|95.0|7.1591|46.2054|||Regression, Logistic|||||46.2054|7.1591|<0.001
71817403|NCT02875834|143137772|OTHER||Mean Difference (Final Values)|7.266|||<|0.001|TWO_SIDED|95.0|4.318|10.214|||Regression, Linear|||Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.||10.214|4.318|<0.001
71817404|NCT02875834|143137772|OTHER||Mean Difference (Final Values)|12.079|||<|0.001|TWO_SIDED|95.0|9.118|15.04|||Regression, Linear|||||15.040|9.118|<0.001
71817405|NCT02875834|143137775|OTHER||Hazard Ratio (HR)|0.443|||<|0.001|TWO_SIDED|95.0|0.2954|0.6631|||Regression, Cox|||Results derived from a Cox Proportional Hazards model with the following covariates: treatment group, both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase), baseline eGFR, age category (\<55, 55-64, \>=65 years), country, baseline RAAS inhibitor, chronic kidney, disease heart failure, and diabetes mellitus statuses.||0.6631|0.2954|<0.001
71817406|NCT02875834|143137775|OTHER||Hazard Ratio (HR)|0.158|||<|0.001|TWO_SIDED|95.0|0.0992|0.2508|||Regression, Cox|||||0.2508|0.0992|<0.001
71817407|NCT01302938|143137785|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-3.9|0.6||||||Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.||0.6|-3.9|
71817408|NCT01302938|143137786|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|29.4|STANDARD_ERROR_OF_MEAN|35.4|||TWO_SIDED|95.0|-47.8|106.6||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||106.6|-47.8|
71817409|NCT01302938|143137786|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|28.0|STANDARD_ERROR_OF_MEAN|38.9|||TWO_SIDED|95.0|-55.4|111.4||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||111.4|-55.4|
71817410|NCT01302938|143137786|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|43.0|STANDARD_ERROR_OF_MEAN|31.4|||TWO_SIDED|95.0|-24.2|110.3||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||110.3|-24.2|
71817411|NCT01302938|143137787|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.67|1.67||||||Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).||1.67|-0.67|
71817412|NCT01302938|143137787|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.58|||||TWO_SIDED|95.0|-1.0|1.83||||||Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.83|-1.00|
71817413|NCT01302938|143137787|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-3.0|1.0||||||Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||1.00|-3.00|
71817414|NCT01302938|143137788|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.3|1.8||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.8|-1.3|
71817415|NCT01302938|143137788|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.2|0.9||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.9|-2.2|
71817416|NCT01302938|143137791|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-0.8|1.9||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||1.9|-0.8|
71849175|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.44|||||TWO_SIDED|95.0|0.89|2.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.34|0.89|
71849176|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.06|||||TWO_SIDED|95.0|0.68|1.64|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.64|0.68|
71849177|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.88|||||TWO_SIDED|95.0|1.05|3.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||3.35|1.05|
71849178|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.48|||||TWO_SIDED|95.0|0.9|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.90|
71899964|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.384||||0.0002|TWO_SIDED|95.0|1.166|1.641|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.641|1.166|0.0002
71849179|NCT00824850|143211892|SUPERIORITY_OR_OTHER||ratio of geometric mean concentrations|1.11|||||TWO_SIDED|95.0|0.75|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.66|0.75|
71817417|NCT01302938|143137791|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|95.0|-3.7|0.8||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.8|-3.7|
71817418|NCT01302938|143137791|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-6.3|0.4||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||0.4|-6.3|
71817419|NCT01302938|143137794|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.0|STANDARD_ERROR_OF_MEAN|10.8|||TWO_SIDED|95.0|-33.2|13.2||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||13.2|-33.2|
71817420|NCT01302938|143137795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.7|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-6.9|30.3||||||Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||30.3|-6.9|
71817421|NCT01302938|143137795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.0|STANDARD_ERROR_OF_MEAN|11.4|||TWO_SIDED|95.0|-16.7|32.7||||||Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||32.7|-16.7|
71817422|NCT01302938|143137795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.3|STANDARD_ERROR_OF_MEAN|10.9|||TWO_SIDED|95.0|-13.3|33.8||||||Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||33.8|-13.3|
71817423|NCT01302938|143137795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.0|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-11.0|29.0||||||Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.||29.0|-11.0|
71817424|NCT01302938|143137796|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-20.0|20.0||||||Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.||20.00|-20.00|
71817425|NCT01233609|143137815|SUPERIORITY||Mean Difference (Net)|-150.43|STANDARD_ERROR_OF_MEAN|71.37||0.035|TWO_SIDED||||||Mixed Models Analysis|degrees of freedom = 830|Right eye and Left Eye within each of the 2 treatment groups (Placebo and Valproic Acid) were combined to estimate the difference|||||0.035
71817426|NCT01233609|143137816|SUPERIORITY|||||||0.581|||||||Mixed Models Analysis|||||||0.581
71817427|NCT01233609|143137817|SUPERIORITY|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
71817428|NCT01233609|143137818|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
71849180|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.5|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.17|0.50|
71849181|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.7|1.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.73|0.70|
71849182|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.61|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.15|0.61|
71849183|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.56|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.25|0.56|
71849184|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.51|1.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.40|0.51|
71849185|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.32|1.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.12|0.32|
71849186|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.85|0.38|
71849187|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.75|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.22|0.75|
71849188|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.82|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.61|0.82|
71849189|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.36|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.13|0.36|
71849190|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.55|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.39|0.55|
71849191|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.73|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.70|0.73|
71849192|NCT00824850|143211893|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.5|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.63|0.50|
71849193|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.35|1.27|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.27|0.35|
71849194|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.77|2.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.05|0.77|
71849195|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.54|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.44|0.54|
71849196|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||0.95|0.38|
71849197|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.64|1.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.91|0.64|
71849198|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.7|||||TWO_SIDED|95.0|0.28|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.62|0.28|
71817429|NCT00405353|143137865|OTHER||||||<|0.05|||||||Mixed Models Analysis|Linear regressions were used to determine slopes of brain volume changes. Statistical software package SAS was used to perform the analysis.||Percent change in brain volume against time scatter plot with a Loess regression curve was produced and a first-degree spline model was developed. This model fitted line pieces for pre-treatment and early treatment periods (month -6 to month 3) and treatment response period (months 3-12), and these pieces were joined together to achieve continuity. Slopes of these lines were estimated and compared. A random intercept was set in the model to allow the difference among subjects.||||<0.05
71817430|NCT00649389|143137866|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817431|NCT00649389|143137866|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71849199|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.68|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.81|0.68|
71849200|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.0|||||TWO_SIDED|95.0|0.53|1.77|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.77|0.53|
71849201|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.1|||||TWO_SIDED|95.0|0.69|1.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.81|0.69|
71849202|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.8|||||TWO_SIDED|95.0|0.32|1.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.85|0.32|
71849203|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.4|||||TWO_SIDED|95.0|0.8|2.36|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.36|0.80|
71849204|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|1.3|||||TWO_SIDED|95.0|0.65|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||2.44|0.65|
71849205|NCT00824850|143211894|SUPERIORITY_OR_OTHER||ratio of geometric mean titers|0.9|||||TWO_SIDED|95.0|0.46|1.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures \[(7vPnC/13vPnC) - (MnCC/13vPnC)\].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).||1.57|0.46|
71849206|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.9|-10.2|
71849207|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849208|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849209|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849210|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849211|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849212|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849213|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849214|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849215|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|3.1|||||TWO_SIDED|95.0|-9.3|17.0||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.0|-9.3|
71849216|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849217|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849218|NCT00824850|143211897|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849219|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|-2.6|||||TWO_SIDED|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||8.0|-13.9|
71899965|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.0002|TWO_SIDED|95.0|1.421|3.074|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.074|1.421|0.0002
71899966|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.288||||0.0006|TWO_SIDED|95.0|0.141|0.588|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.588|0.141|0.0006
71899967|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247||||0.0013|TWO_SIDED|95.0|0.106|0.579|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.579|0.106|0.0013
71899968|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.959||||0.0062|TWO_SIDED|95.0|0.931|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.931|0.0062
71899969|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.708||||0.002|TWO_SIDED|95.0|0.568|0.881|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.881|0.568|0.0020
71899970|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.434|||<|0.0001|TWO_SIDED|95.0|1.288|1.596|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.596|1.288|<0.0001
71899971|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.26|1.726|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.726|1.260|<0.0001
71899972|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.963|||<|0.0001|TWO_SIDED|95.0|0.956|0.97|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.956|<0.0001
71899973|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.195|||<|0.0001|TWO_SIDED|95.0|1.12|1.275|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.275|1.120|<0.0001
71899974|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.567||||0.0316|TWO_SIDED|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.359|1.040|0.0316
71899975|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.495||||0.0024|TWO_SIDED|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||11.879|1.701|0.0024
71899976|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112||||0.0247|TWO_SIDED|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.219|1.014|0.0247
71817432|NCT00649389|143137866|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71849220|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-10.2|
71849221|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849222|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.5|
71849223|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849224|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.1|10.5||||||7vPnC serotype 19F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.5|-10.1|
71849225|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|3.0|||||TWO_SIDED|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||16.6|-9.1|
71817433|NCT00649389|143137867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
71817434|NCT00649389|143137867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
71817435|NCT00649389|143137867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.||||<0.0001
71817436|NCT00649389|143137868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71849226|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-10.0|10.1||||||Additional serotype 1: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.1|-10.0|
71849227|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.4|10.3||||||Additional serotype 3: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.3|-9.4|
71849228|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|3.3|||||TWO_SIDED|95.0|-8.6|17.2||||||Additional serotype 5: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||17.2|-8.6|
71849229|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849230|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.7|10.6||||||Additional serotype 7F: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.6|-9.7|
71817437|NCT00649389|143137868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817438|NCT00649389|143137868|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||0.0001
71817439|NCT00649389|143137868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71849231|NCT00824850|143211898|SUPERIORITY_OR_OTHER||difference in proportions|0.0|||||TWO_SIDED|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, \[(7vPnC/13vPnC) - (MnCC/13vPnC)\], expressed as a percentage, along with exact 2-sided confidence interval.||10.0|-9.5|
71849232|NCT03976323|143211907|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.8721|TWO_SIDED|95.0|0.92|1.36||One-sided p-value based on log-rank test stratified by Eastern Cooperative Oncology Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.36|0.92|0.8721
71849233|NCT03976323|143211908|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6649|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|Log Rank||Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.|||1.25|0.87|0.6649
71817440|NCT00649389|143137868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817441|NCT00649389|143137868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817442|NCT00649389|143137869|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817443|NCT00649389|143137869|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817444|NCT00649389|143137869|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.||||<0.0001
71817445|NCT01976364|143137878|OTHER||Least Squares (LS) Mean difference|0.0255|||||TWO_SIDED|95.0|-0.0513|0.1022||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1022|-0.0513|
71817446|NCT01976364|143137879|OTHER||LS mean difference|0.091|||||TWO_SIDED|95.0|-0.131|0.313||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.313|-0.131|
71817447|NCT01976364|143137913|OTHER||LS Mean Difference|0.0486|||||TWO_SIDED|95.0|-0.0192|0.1163||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1163|-0.0192|
71817448|NCT01976364|143137913|OTHER||LS Mean Difference|0.0325|||||TWO_SIDED|95.0|-0.0372|0.1021||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1021|-0.0372|
71817449|NCT01976364|143137913|OTHER||LS Mean Difference|-0.0058|||||TWO_SIDED|95.0|-0.0941|0.0825||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0825|-0.0941|
71817450|NCT01976364|143137913|OTHER||LS Mean Difference|0.0096|||||TWO_SIDED|95.0|-0.0734|0.0927||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0927|-0.0734|
71817451|NCT01976364|143137914|OTHER||LS Mean Difference|0.032|||||TWO_SIDED|95.0|-0.163|0.227||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.227|-0.163|
71817452|NCT01976364|143137914|OTHER||LS Mean Difference|-0.024|||||TWO_SIDED|95.0|-0.266|0.219||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.219|-0.266|
71817453|NCT01976364|143137914|OTHER||LS Mean Difference|0.213|||||TWO_SIDED|95.0|-0.045|0.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.470|-0.045|
71817454|NCT01976364|143137914|OTHER||LS Mean Difference|-0.061|||||TWO_SIDED|95.0|-0.309|0.188||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.188|-0.309|
71817455|NCT01976364|143137915|OTHER||Difference in percentage of participants|-0.14|||||TWO_SIDED|95.0|-9.76|9.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||9.48|-9.76|
71817456|NCT01976364|143137915|OTHER||Difference in percentage of participants|-4.57|||||TWO_SIDED|95.0|-12.91|3.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||3.77|-12.91|
71817457|NCT01976364|143137915|OTHER||Difference in percentage of participants|-5.69|||||TWO_SIDED|95.0|-14.26|2.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||2.87|-14.26|
71817458|NCT01976364|143137915|OTHER||Difference in percentage of participants|-2.36|||||TWO_SIDED|95.0|-11.59|6.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||6.87|-11.59|
71817459|NCT01976364|143137915|OTHER||Difference in percentage of participants|-10.15|||||TWO_SIDED|95.0|-18.16|-2.14||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||-2.14|-18.16|
71817460|NCT01976364|143137916|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.1|
71817461|NCT01976364|143137916|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.1|
71849234|NCT03976323|143211911|SUPERIORITY||Difference in Least Squares (LS) Means|-1.9||||0.2533|TWO_SIDED|95.0|-5.16|1.36||Two-sided p-value based on t test.|t-test, 2 sided||Based on constrained longitudinal data analysis model (cLDA) model with PRO scores as response variable with covariates for treatment by time interaction, stratification factors, response at randomization and baseline PD-L1 expression as covariates.|||1.36|-5.16|0.2533
71817462|NCT01976364|143137916|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|0.0|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|0.0|
71849235|NCT03976323|143211912|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8125|TWO_SIDED|95.0|0.76|1.24||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.24|0.76|0.8125
71817463|NCT01976364|143137916|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|0.1|
71849236|NCT03976323|143211913|SUPERIORITY||Difference in LS Means|-0.16||||0.9364|TWO_SIDED|95.0|-4.02|3.71||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||3.71|-4.02|0.9364
71849237|NCT03976323|143211914|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.3782|TWO_SIDED|95.0|0.66|1.17||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.17|0.66|0.3782
71849238|NCT03976323|143211915|SUPERIORITY||Difference in LS Means|-0.35||||0.8285|TWO_SIDED|95.0|-3.54|2.83||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.83|-3.54|0.8285
71849239|NCT03976323|143211916|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6272|TWO_SIDED|95.0|0.78|1.51||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.51|0.78|0.6272
71817464|NCT01976364|143137916|OTHER||LS mean difference|0.3|||||TWO_SIDED|95.0|-0.1|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.1|
71817465|NCT01976364|143137917|OTHER||LS mean difference|-19.43|||||TWO_SIDED|95.0|-58.06|19.21||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||19.21|-58.06|
71817466|NCT01976364|143137917|OTHER||LS mean difference|-30.11|||||TWO_SIDED|95.0|-83.58|23.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||23.37|-83.58|
71817467|NCT01976364|143137917|OTHER||LS mean difference|-24.33|||||TWO_SIDED|95.0|-83.35|34.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||34.69|-83.35|
71849240|NCT03976323|143211917|SUPERIORITY||Difference in LS Means|-1.51||||0.4422|TWO_SIDED|95.0|-5.38|2.35||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.35|-5.38|0.4422
71849241|NCT03976323|143211918|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9156|TWO_SIDED|95.0|0.74|1.31||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.31|0.74|0.9156
71849242|NCT03976323|143211919|SUPERIORITY||Difference in LS Means|-0.01||||0.9962|TWO_SIDED|95.0|-2.94|2.93||Two-sided p-value based on t test.|t-test, 2 sided||Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.|||2.93|-2.94|0.9962
71849243|NCT03976323|143211920|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.5517|TWO_SIDED|95.0|0.83|1.4||Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.|||1.40|0.83|0.5517
71899977|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.844||||0.0258|TWO_SIDED|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.077|0.0258
71817468|NCT01976364|143137917|OTHER||LS mean difference|-11.64|||||TWO_SIDED|95.0|-60.87|37.58||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||37.58|-60.87|
71849244|NCT00535626|143211929|OTHER|"To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis).~Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients."|Revision or Pending Revision Rate|2.43|||||TWO_SIDED|90.0|1.07|5.46|||||The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.|||5.46|1.07|
71849245|NCT00535626|143211930|OTHER|To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
71849246|NCT00535626|143211931|OTHER|To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
71849247|NCT00535626|143211931|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.||||||0.0139|||||||t-test, 2 sided|Paired t-test||||||0.0139
71817469|NCT01976364|143137917|OTHER||LS mean difference|7.02|||||TWO_SIDED|95.0|-49.73|63.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||63.77|-49.73|
71817470|NCT01976364|143137919|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
71817471|NCT01976364|143137919|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
71817472|NCT01976364|143137919|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
71817473|NCT01976364|143137919|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
71849248|NCT00535626|143211931|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.||||||0.0254|||||||t-test, 2 sided|Paired t-test||||||0.0254
71849249|NCT00535626|143211931|OTHER|To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.||||||0.1506|||||||t-test, 2 sided|Paired t-test||||||0.1506
71849250|NCT00535626|143211931|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.||||||0.0936|||||||t-test, 2 sided|Paired t-test||||||0.0936
71849251|NCT00535626|143211931|OTHER|To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.||||||0.0909|||||||t-test, 2 sided|Paired t-test||||||0.0909
71849252|NCT00535626|143211931|OTHER|To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.||||||0.048|||||||t-test, 2 sided|Paired t-test||||||0.048
71849253|NCT00535626|143211934|OTHER|To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.||||||0.0011|||||||t-test, 2 sided|Paired t-test||||||0.0011
71849254|NCT00535626|143211934|OTHER|To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.|||||<|0.0001||||||This p-value applies to pre-op to 1, 2 and 3 year intervals.|t-test, 2 sided|Paired t-test||||||<0.0001
71849255|NCT00535626|143211934|OTHER|To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.||||||0.0002|||||||t-test, 2 sided|Paired t-test||||||0.0002
71849256|NCT00535626|143211934|OTHER|To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.||||||0.0009|||||||t-test, 2 sided|Paired t-test||||||0.0009
71849257|NCT01277302|143211939|SUPERIORITY_OR_OTHER||Estimated interaction effect|0.071|STANDARD_ERROR_OF_MEAN|0.107||0.5091||||||This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p \< 0.05 (2-sided) was required for significance.|Longitudinal mixed model|The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, \>35 to ≤50, or \>50 letters).||The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.||||0.5091
71849258|NCT00731692|143211951|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.544|TWO_SIDED|95.0|0.8|1.12|||Regression, Cox|||||1.12|0.80|0.544
71849259|NCT00108355|143211984|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Log Rank|||Initial estimation: median time to recurrence of ascites of 38 days in the study group and 20 days in the control group in a fixed duration of 6 months (5% type-I error (2 sided) and an 80% power). However, due to low accrual and based on randomized trials using vasoconstrictors in the prevention of PCD and a study that showed that midodrine leads to a significant improvement in effective arterial blood volume, each of which had sample sizes of 24-25 patients,we decided on a sample size of 30.||||<0.05
71899978|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.0009|TWO_SIDED|95.0|1.232|2.235|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.235|1.232|0.0009
71899979|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.255||||0.0045|TWO_SIDED|95.0|1.073|1.467|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.467|1.073|0.0045
71899980|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.086||||0.0001|TWO_SIDED|95.0|1.434|3.034|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.034|1.434|0.0001
71849260|NCT01928732|143211996|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|1.0|1.65|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Response Odds Ratio (OR). Response is defined as greater than or equal to 10 point improvement in severity.||1.65|1.00|
71849261|NCT01928732|143211996|SUPERIORITY||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|1.12|1.74|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Loss of Diagnosis Odds Ratio (OR). Loss of Diagnosis is defined as Response, plus no longer meeting DSM-5 symptom criteria and severity less than 25.||1.74|1.12|
71899981|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.318||||0.001|TWO_SIDED|95.0|0.16|0.63|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.630|0.160|0.0010
71817474|NCT01976364|143137919|OTHER||Difference in percentage of participants|6.25|||||TWO_SIDED|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||72.08|-59.58|
71849262|NCT01928732|143211996|SUPERIORITY||Odds Ratio (OR)|1.62|||||TWO_SIDED|95.0|1.24|2.0|||||Odds ratios were calculated with CPT as the reference group and reflect the overall main effect of treatment across all outcome assessments (post-treatment, 3-months, and 6-months)|Overall Treatment Effect Remission Odds Ratio (OR). Remission is defined as loss of diagnosis plus severity less than 12.||2.00|1.24|
71849263|NCT01185340|143212004|SUPERIORITY_OR_OTHER|||||||0.751|||||||Mixed Models Analysis|||||||0.751
71849264|NCT00087516|143212023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-0.96|-0.62|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.62|-0.96|<0.001
71849265|NCT00087516|143212023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.94|STANDARD_ERROR_OF_MEAN|0.09|<|0.001||95.0|-1.11|-0.77|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C||||-0.77|-1.11|<0.001
71849266|NCT00087516|143212024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.1|STANDARD_ERROR_OF_MEAN|3.6|<|0.001||95.0|-24.1|-10.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-10.1|-24.1|<0.001
71849267|NCT00087516|143212024|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.5|<|0.001||95.0|-28.2|-14.4|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG||||-14.4|-28.2|<0.001
71849268|NCT00087516|143212025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.7|STANDARD_ERROR_OF_MEAN|6.5|<|0.001||95.0|-59.4|-34.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-34.1|-59.4|<0.001
71849269|NCT00087516|143212025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.001||95.0|-66.7|-41.6|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG||||-41.6|-66.7|<0.001
71849270|NCT02065895|143212029|OTHER|ANOVA was used to first tests the hypothesis that there is a difference among the three groups.|Mean Difference (Final Values)|66.8||||0.0011|TWO_SIDED|95.0|33.4|80.3||The p value was adjusted for multiple comparisons using Sidak's correction. A priori the pimary outcome was defined as blood glucose AUC from 8 am - 12pm; however we used blood glucose AUC from 8am - 2pm to capture the entire meal response.|ANOVA|||Differences among the 3 groups were assessed by repeated measures ANOVA using Sidak's correction for multiple comparisons. All subjects were analyzed as a single group, no comparison group.||80.3|33.4|0.0011
71849271|NCT02065895|143212030|OTHER|||||||0.0059|||||||ANOVA|||||||0.0059
71849272|NCT01093690|143212032|SUPERIORITY_OR_OTHER|||||||0.41||||||No adjustment.|Chi-squared|1-sided test||the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)||||0.41
71849273|NCT00569166|143212036|SUPERIORITY_OR_OTHER|||||||0.3679||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.3679
71849274|NCT00569166|143212036|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.||||0.4715
71817475|NCT01976364|143137920|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
71849275|NCT00486954|143212083|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2088|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||||1.11|0.64|0.2088
71899982|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.275||||0.0021|TWO_SIDED|95.0|0.121|0.626|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.626|0.121|0.0021
71817476|NCT01976364|143137920|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.9|
71817477|NCT01976364|143137920|OTHER||LS mean difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.1|
71849276|NCT00321971|143212142|SUPERIORITY||Mean Difference (Final Values)|0.421|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|0.208|0.657|||Mixed Models Analysis|Intention-to-treat model|The CES-D data were log-transformed for analysis|Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.||0.657|0.208|<.05
71849277|NCT01918033|143212157|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.09||||0.661|TWO_SIDED|95.0|-0.49|0.31|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.31|-0.49|0.661
71849278|NCT01918033|143212157|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.707|TWO_SIDED|95.0|-0.48|0.32|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2|||0.32|-0.48|0.707
71849279|NCT01918033|143212160|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.48||||0.01|TWO_SIDED|95.0|-0.84|-0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.11|-0.84|0.010
71817478|NCT01976364|143137920|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.6|
71817479|NCT01976364|143137920|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-0.6|
71817480|NCT01976364|143137922|OTHER||Difference in percentage of participants|11.67|||||TWO_SIDED|95.0|-15.65|38.98||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||38.98|-15.65|
71849280|NCT01918033|143212160|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.46||||0.013|TWO_SIDED|95.0|-0.82|-0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3|||-0.10|-0.82|0.013
71849281|NCT01918033|143212160|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.569|TWO_SIDED|95.0|-0.29|0.53|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.53|-0.29|0.569
71849282|NCT01918033|143212160|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.09||||0.685|TWO_SIDED|95.0|-0.33|0.5|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1|||0.50|-0.33|0.685
71899983|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.962||||0.0064|TWO_SIDED|95.0|0.935|0.989|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.989|0.935|0.0064
71899984|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.391|||<|0.0001|TWO_SIDED|95.0|1.245|1.553|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.553|1.245|<0.0001
71899985|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.295||||0.0029|TWO_SIDED|95.0|1.092|1.535|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.535|1.092|0.0029
71899986|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.109|||<|0.0001|TWO_SIDED|95.0|0.05|0.236|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.236|0.050|<0.0001
71899987|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0014|TWO_SIDED|95.0|0.159|0.645|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.645|0.159|0.0014
71899988|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.248||||0.539|TWO_SIDED|95.0|0.616|2.528|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.528|0.616|0.5390
71899989|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.604||||0.0223|TWO_SIDED|95.0|1.069|2.405|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.405|1.069|0.0223
71817481|NCT01976364|143137922|OTHER||Difference in percentage of participants|30.42|||||TWO_SIDED|95.0|0.64|60.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||60.20|0.64|
71817482|NCT01976364|143137922|OTHER||Difference in percentage of participants|29.58|||||TWO_SIDED|95.0|-3.46|62.62||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||62.62|-3.46|
71817483|NCT01976364|143137922|OTHER||Difference in percentage of participants|24.17|||||TWO_SIDED|95.0|-5.14|53.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||53.47|-5.14|
71817484|NCT01976364|143137922|OTHER||Difference in percentage of participants|17.08|||||TWO_SIDED|95.0|-15.96|50.12||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||50.12|-15.96|
71817485|NCT01976364|143137923|OTHER||Difference in percentage of participants|4.99|||||TWO_SIDED|95.0|-9.61|19.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||19.60|-9.61|
71817486|NCT01976364|143137923|OTHER||Difference in percentage of participants|3.88|||||TWO_SIDED|95.0|-10.74|18.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.50|-10.74|
71899990|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.444||||0.0056|TWO_SIDED|95.0|1.547|12.766|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.766|1.547|0.0056
71899991|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.403||||0.0267|TWO_SIDED|95.0|1.04|1.892|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.892|1.040|0.0267
71899992|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.226||||0.0018|TWO_SIDED|95.0|0.089|0.575|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.575|0.089|0.0018
71899993|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.529||||0.0083|TWO_SIDED|95.0|1.116|2.097|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.097|1.116|0.0083
71849283|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.547|TWO_SIDED|95.0|-0.15|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.08|-0.15|0.547
71679413|NCT02045862|142876844|SUPERIORITY||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED|95.0|-0.69|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.69|0.002
71679414|NCT02045862|142876844|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.14||0.039|TWO_SIDED|95.0|-0.55|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.01|-0.55|0.039
71679415|NCT02045862|142876845|SUPERIORITY||Rate Ratio|0.58|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|0.45|0.76|||Negative Binomial Regression|||Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.76|0.45|<0.001
71679416|NCT02045862|142876845|SUPERIORITY||Rate Ratio|0.76|STANDARD_ERROR_OF_MEAN|0.14||0.044|TWO_SIDED|95.0|0.58|0.99|||Negative Binomial Regression|||Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.||0.99|0.58|0.044
71679417|NCT02045862|142876846|SUPERIORITY||Least Squares Mean Difference|-2.98|STANDARD_ERROR_OF_MEAN|0.92||0.001|TWO_SIDED|95.0|-4.78|-1.18|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-1.18|-4.78|0.001
71679418|NCT02045862|142876846|SUPERIORITY||Least Squares Mean Difference|-1.68|STANDARD_ERROR_OF_MEAN|0.93||0.072|TWO_SIDED|95.0|-3.52|0.15|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||0.15|-3.52|0.072
71679419|NCT02045862|142876848|SUPERIORITY||Least Squares Mean Difference|4.76|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|2.56|6.96|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.96|2.56|<0.001
71679420|NCT02045862|142876848|SUPERIORITY||Least Squares Mean Difference|2.86|STANDARD_ERROR_OF_MEAN|1.11||0.01|TWO_SIDED|95.0|0.68|5.04|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.04|0.68|0.010
71679421|NCT02045862|142876849|SUPERIORITY||Least Squares Mean Difference|5.6|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|2.99|8.2|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||8.20|2.99|<0.001
71679422|NCT02045862|142876849|SUPERIORITY||Least Squares Mean Difference|3.01|STANDARD_ERROR_OF_MEAN|1.32||0.022|TWO_SIDED|95.0|0.43|5.6|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.60|0.43|0.022
71679423|NCT02045862|142876850|SUPERIORITY||Least Squares Mean Difference|5.01|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|2.65|7.38|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.38|2.65|<0.001
71849284|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.067|TWO_SIDED|95.0|-0.22|0.01|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2|||0.01|-0.22|0.067
71679424|NCT02045862|142876850|SUPERIORITY||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|1.43|6.13|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||6.13|1.43|0.002
71679425|NCT02045862|142876851|SUPERIORITY||Least Squares Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|1.36|<|0.001|TWO_SIDED|95.0|2.47|7.83|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||7.83|2.47|<0.001
71679426|NCT02045862|142876851|SUPERIORITY||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|1.35||0.016|TWO_SIDED|95.0|0.62|5.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||5.93|0.62|0.016
71679427|NCT02045862|142876852|SUPERIORITY||Least Squares Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|0.98||0.006|TWO_SIDED|95.0|0.77|4.59|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||4.59|0.77|0.006
71679428|NCT02045862|142876852|SUPERIORITY||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.97||0.287|TWO_SIDED|95.0|-0.87|2.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||2.93|-0.87|0.287
71679429|NCT02045862|142876854|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.16|-0.47|<0.001
71679430|NCT02045862|142876854|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.36|-0.05|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.||-0.05|-0.36|0.011
71679431|NCT02045862|142876866|SUPERIORITY||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.26|2.15|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||2.15|1.26|<0.001
71679432|NCT02045862|142876866|SUPERIORITY||Odds Ratio (OR)|1.27||||0.08|TWO_SIDED|95.0|0.97|1.67|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.||1.67|0.97|0.080
71679433|NCT02045862|142876867|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.001|TWO_SIDED|95.0|1.49|2.78|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.78|1.49|<0.001
71817487|NCT01976364|143137923|OTHER||Difference in percentage of participants|2.82|||||TWO_SIDED|95.0|-11.8|17.45||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.45|-11.80|
71817488|NCT01976364|143137923|OTHER||Difference in percentage of participants|3.97|||||TWO_SIDED|95.0|-10.58|18.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||18.52|-10.58|
71817489|NCT01976364|143137923|OTHER||Difference in percentage of participants|2.87|||||TWO_SIDED|95.0|-11.63|17.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.||17.37|-11.63|
71817490|NCT01976364|143137924|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-1.5|
71817491|NCT01976364|143137924|OTHER||LS mean difference|-0.4|||||TWO_SIDED|95.0|-1.6|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-1.6|
71817492|NCT01976364|143137924|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-1.0|
71849285|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.895|TWO_SIDED|95.0|-0.15|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.13|-0.15|0.895
71849286|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.627|TWO_SIDED|95.0|-0.1|0.17|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2|||0.17|-0.10|0.627
71849287|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.535|TWO_SIDED|95.0|-0.09|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.09|0.535
71849288|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.04||||0.557|TWO_SIDED|95.0|-0.1|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2|||0.18|-0.10|0.557
71849289|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.11||||0.119|TWO_SIDED|95.0|-0.25|0.03|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.03|-0.25|0.119
71849290|NCT01918033|143212161|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.403|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2|||0.08|-0.20|0.403
71849291|NCT01918033|143212162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.376|TWO_SIDED|95.0|-0.2|0.07|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.07|-0.20|0.376
71849292|NCT01918033|143212162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.714|TWO_SIDED|95.0|-0.16|0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2|||0.11|-0.16|0.714
71849293|NCT01918033|143212162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.725|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.725
71849294|NCT01918033|143212162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.708|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2|||0.13|-0.19|0.708
71849295|NCT01918033|143212162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.03||||0.68|TWO_SIDED|95.0|-0.1|0.16|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.16|-0.10|0.680
71849296|NCT01918033|143212162|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.06||||0.373|TWO_SIDED|95.0|-0.07|0.19|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2|||0.19|-0.07|0.373
71849297|NCT01918033|143212163|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.849|TWO_SIDED|95.0|-0.14|0.12|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.12|-0.14|0.849
71849298|NCT01918033|143212163|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.26|TWO_SIDED|95.0|-0.2|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2|||0.06|-0.20|0.260
71899994|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.285||||0.0028|TWO_SIDED|95.0|1.09|1.515|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.515|1.090|0.0028
71849299|NCT01918033|143212164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.826||||0.34|TWO_SIDED|95.0|0.558|1.223|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.223|0.558|0.340
71899995|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.061||||0.0002|TWO_SIDED|95.0|1.401|3.032|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.032|1.401|0.0002
71899996|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.327||||0.0019|TWO_SIDED|95.0|0.162|0.662|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.662|0.162|0.0019
71817493|NCT01976364|143137924|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.9|-0.9|
71817494|NCT01976364|143137924|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.1|-0.7|
71817495|NCT01976364|143137925|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.3|
71817496|NCT01976364|143137925|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.6|-0.6|
71817497|NCT01976364|143137925|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.4|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.5|-0.4|
71817498|NCT01976364|143137925|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-0.3|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-0.3|
71817499|NCT01976364|143137925|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.3|-0.5|
71817500|NCT01976364|143137926|OTHER||LS mean difference|0.26|||||TWO_SIDED|95.0|-2.51|3.02||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.02|-2.51|
71817501|NCT01976364|143137926|OTHER||LS mean difference|0.77|||||TWO_SIDED|95.0|-2.64|4.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.18|-2.64|
71817502|NCT01976364|143137926|OTHER||LS mean difference|0.47|||||TWO_SIDED|95.0|-2.26|3.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.20|-2.26|
71817503|NCT01976364|143137926|OTHER||LS mean difference|2.18|||||TWO_SIDED|95.0|-1.46|5.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.81|-1.46|
71817504|NCT01976364|143137926|OTHER||LS mean difference|-0.12|||||TWO_SIDED|95.0|-3.25|3.01||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.01|-3.25|
71817505|NCT01976364|143137927|OTHER||LS mean difference|-2.03|||||TWO_SIDED|95.0|-5.58|1.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.52|-5.58|
71817506|NCT01976364|143137927|OTHER||LS mean difference|-0.43|||||TWO_SIDED|95.0|-4.69|3.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.84|-4.69|
71849300|NCT01918033|143212164|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.755||||0.159|TWO_SIDED|95.0|0.51|1.116|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio \>1 is in favor of the first group of the pairwise comparison.|||1.116|0.510|0.159
71849301|NCT01918033|143212165|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.705|TWO_SIDED|95.0|-0.09|0.14|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.14|-0.09|0.705
71849302|NCT01918033|143212165|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.02||||0.782|TWO_SIDED|95.0|-0.13|0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2|||0.10|-0.13|0.782
71817507|NCT01976364|143137927|OTHER||LS mean difference|1.29|||||TWO_SIDED|95.0|-3.48|6.06||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.06|-3.48|
71817508|NCT01976364|143137927|OTHER||LS mean difference|0.64|||||TWO_SIDED|95.0|-4.03|5.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.32|-4.03|
71817509|NCT01976364|143137927|OTHER||LS mean difference|-0.13|||||TWO_SIDED|95.0|-4.64|4.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||4.38|-4.64|
71817510|NCT01976364|143137928|OTHER||LS mean difference|-1.11|||||TWO_SIDED|95.0|-4.96|2.74||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.74|-4.96|
71817511|NCT01976364|143137928|OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-5.11|2.65||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.65|-5.11|
71817512|NCT01976364|143137928|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-3.78|5.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.69|-3.78|
71817513|NCT01976364|143137928|OTHER||LS mean difference|2.01|||||TWO_SIDED|95.0|-2.92|6.93||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||6.93|-2.92|
71817514|NCT01976364|143137928|OTHER||LS mean difference|0.66|||||TWO_SIDED|95.0|-4.03|5.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||5.35|-4.03|
71817515|NCT01976364|143137929|OTHER||LS mean difference|-0.1535|||||TWO_SIDED|95.0|-2.1444|1.8374||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.8374|-2.1444|
71817516|NCT01976364|143137929|OTHER||LS mean difference|-0.566|||||TWO_SIDED|95.0|-1.9054|0.7735||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7735|-1.9054|
71817517|NCT01976364|143137929|OTHER||LS mean difference|-0.7991|||||TWO_SIDED|95.0|-3.0053|1.4071||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.4071|-3.0053|
71817518|NCT01976364|143137929|OTHER||LS mean difference|0.0626|||||TWO_SIDED|95.0|-1.5767|1.7018||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7018|-1.5767|
71817519|NCT01976364|143137929|OTHER||LS mean difference|0.3672|||||TWO_SIDED|95.0|-1.8107|2.545||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5450|-1.8107|
71817520|NCT01976364|143137930|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-0.85|1.51||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.51|-0.85|
71817521|NCT01976364|143137930|OTHER||LS mean difference|0.33|||||TWO_SIDED|95.0|-1.04|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-1.04|
71817522|NCT01976364|143137930|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.09|0.55||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.55|-2.09|
71817523|NCT01976364|143137930|OTHER||LS mean difference|-0.77|||||TWO_SIDED|95.0|-2.44|0.91||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.91|-2.44|
71817524|NCT01976364|143137930|OTHER||LS mean difference|0.52|||||TWO_SIDED|95.0|-0.96|2.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.00|-0.96|
71817525|NCT01976364|143137931|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.22|1.29||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.29|-2.22|
71817526|NCT01976364|143137931|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.65|0.92||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.92|-2.65|
71899997|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.0086|TWO_SIDED|95.0|0.137|0.749|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.749|0.137|0.0086
71899998|NCT01070550|143322227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.247|||<|0.0001|TWO_SIDED|95.0|0.138|0.441|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.441|0.138|<0.0001
71899999|NCT04964063|143322282|OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.47|-1.19|||ANOVA||Q1: How intense are the sensation|||-1.19|-1.47|<.0001
71900000|NCT04964063|143322282|OTHER||Mean Difference (Final Values)|-1.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.77|-1.45|||ANOVA||Q2: How bothered are you by any sensation|||-1.45|-1.77|<.0001
71900001|NCT04964063|143322282|OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.33|-1.0|||ANOVA||Q3: How well can you tolerate sensations|||-1.00|-1.33|<.0001
71900002|NCT04964063|143322283|OTHER||Median Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.98|-1.7|||ANOVA||Q1: How intense are the sensation|||-1.70|-1.98|<.0001
71900003|NCT04964063|143322283|OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.33|-2.02|||ANOVA||Q2: How bothered are you by any sensation|||-2.02|-2.33|<.0001
71900004|NCT04964063|143322283|OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-1.61|-1.29|||ANOVA||Q3: How well can you tolerate sensations|||-1.29|-1.61|<.0001
71900005|NCT04964063|143322284|OTHER||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.43|-2.15|||ANOVA||Q1: How intense are the sensation|||-2.15|-2.43|<.0001
71900006|NCT04964063|143322284|OTHER||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.79|-2.47|||ANOVA||Q2: How bothered are you by any sensation|||-2.47|-2.79|<.0001
71900007|NCT04964063|143322284|OTHER||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.02|-1.7|||ANOVA||Q3: How well can you tolerate sensations|||-1.70|-2.02|<.0001
71900008|NCT04964063|143322285|OTHER||Mean Difference (Final Values)|-2.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.68|-2.4|||ANOVA||Q1: How intense are the sensation|||-2.40|-2.68|<.0001
71900009|NCT04964063|143322285|OTHER||Mean Difference (Final Values)|-2.89|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.05|-2.73|||ANOVA||Q2: How bothered are you by any sensation|||-2.73|-3.05|<.0001
71900010|NCT04964063|143322285|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.2|-1.87|||ANOVA||Q3: How well can you tolerate sensations|||-1.87|-2.20|<.0001
71900011|NCT04964063|143322286|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-2.84|-2.55|||ANOVA||Q1: How intense are the sensation|||-2.55|-2.84|<.0001
71900012|NCT04964063|143322286|OTHER||Mean Difference (Final Values)|-2.99|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.15|-2.83|||ANOVA||Q2: How bothered are you by any sensation|||-2.83|-3.15|<.0001
71900013|NCT04964063|143322286|OTHER||Mean Difference (Final Values)|-2.18|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.35|-2.02|||ANOVA||Q3: How well can you tolerate sensations|||-2.02|-2.35|<.0001
71900014|NCT04964063|143322287|OTHER||Median Difference (Final Values)|-2.94|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-3.08|-2.79|||ANOVA||Q1: How intense are the sensation|||-2.79|-3.08|<.0001
71900015|NCT04964063|143322287|OTHER||Median Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-3.4|-3.08|||ANOVA||Q2: How bothered are you by any sensation|||-3.08|-3.40|<.0001
71900016|NCT04964063|143322287|OTHER||Mean Difference (Final Values)|-2.37|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-2.53|-2.21|||ANOVA||Q3: How well can you tolerate sensations|||-2.21|-2.53|<.0001
71900017|NCT04964063|143322289|OTHER||Mean Difference (Final Values)|-17.93|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-20.81|-15.05|||ANOVA|||||-15.05|-20.81|<.0001
71900018|NCT04964063|143322290|OTHER||Mean Difference (Final Values)|-31.2|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-34.04|-28.36|||ANOVA|||||-28.36|-34.04|<.0001
71900019|NCT04964063|143322291|OTHER||Mean Difference (Final Values)|-39.45|STANDARD_ERROR_OF_MEAN|1.9|<|0.0001|TWO_SIDED|95.0|-42.3|-36.59|||ANOVA|||||-36.59|-42.30|<.0001
71900020|NCT04964063|143322292|OTHER||Mean Difference (Final Values)|-44.37|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-47.24|-41.49|||ANOVA|||||-41.49|-47.24|<.0001
71900021|NCT04964063|143322293|OTHER||Mean Difference (Final Values)|-48.04|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-50.96|-45.12|||ANOVA|||||-45.12|-50.96|<.0001
71900022|NCT04964063|143322294|OTHER||Mean Difference (Final Values)|-52.47|STANDARD_ERROR_OF_MEAN|1.91|<|0.0001|TWO_SIDED|95.0|-55.33|-49.62|||ANOVA|||||-49.62|-55.33|<.0001
71900023|NCT04964063|143322296|OTHER||Mean Difference (Final Values)|-2.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.88|-2.02|||ANOVA|||||-2.02|-2.88|<.0001
71900024|NCT04964063|143322297|OTHER||Mean Difference (Final Values)|-4.27|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-4.69|-3.85|||ANOVA|||||-3.85|-4.69|<.0001
71900025|NCT04964063|143322298|OTHER||Mean Difference (Final Values)|-5.71|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-6.13|-5.28|||ANOVA|||||-5.28|-6.13|<.0001
71900026|NCT04964063|143322299|OTHER||Mean Difference (Final Values)|-6.45|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-6.88|-6.02|||ANOVA|||||-6.02|-6.88|<.0001
71900027|NCT04964063|143322300|OTHER||Median Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-7.45|-6.58|||ANOVA|||||-6.58|-7.45|<.0001
71900028|NCT04964063|143322301|OTHER||Mean Difference (Final Values)|-7.44|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-7.87|-7.01|||ANOVA|||||-7.01|-7.87|<.0001
71900029|NCT04964063|143322303|OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-7.46|-5.2|||ANOVA|||||-5.20|-7.46|<.0001
71900030|NCT04964063|143322304|OTHER||Mean Difference (Final Values)|-11.53|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-12.64|-10.41|||ANOVA|||||-10.41|-12.64|<.0001
71817527|NCT01976364|143137931|OTHER||LS mean difference|-0.66|||||TWO_SIDED|95.0|-2.68|1.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.36|-2.68|
71817528|NCT01976364|143137931|OTHER||LS mean difference|0.76|||||TWO_SIDED|95.0|-1.31|2.83||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.83|-1.31|
71900031|NCT04964063|143322305|OTHER||Mean Difference (Final Values)|-14.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-15.66|-13.42|||ANOVA|||||-13.42|-15.66|<.0001
71900032|NCT04964063|143322306|OTHER||Median Difference (Final Values)|-16.54|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-17.67|-15.41|||ANOVA|||||-15.41|-17.67|<.0001
71817529|NCT01976364|143137931|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.01|1.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.84|-2.01|
71900033|NCT04964063|143322307|OTHER||Mean Difference (Final Values)|-17.73|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-18.87|-16.58|||ANOVA|||||-16.58|-18.87|<.0001
71900034|NCT04964063|143322308|OTHER||Mean Difference (Final Values)|-18.84|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-19.96|-17.72|||ANOVA|||||-17.72|-19.96|<.0001
71900035|NCT04964063|143322310|OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.52|-1.56|||ANOVA|||||-1.56|-2.52|<.0001
71900036|NCT04964063|143322311|OTHER||Mean Difference (Final Values)|-3.69|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-4.17|-3.22|||ANOVA|||||-3.22|-4.17|<.0001
71900037|NCT04964063|143322312|OTHER||Mean Difference (Final Values)|-4.67|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.15|-4.2|||ANOVA|||||-4.20|-5.15|<.0001
71817530|NCT01976364|143137932|OTHER||LS mean difference|0.22|||||TWO_SIDED|95.0|-1.09|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.09|
71817531|NCT01976364|143137932|OTHER||LS mean difference|0.17|||||TWO_SIDED|95.0|-1.39|1.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.73|-1.39|
71817532|NCT01976364|143137932|OTHER||LS mean difference|-0.53|||||TWO_SIDED|95.0|-2.15|1.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.08|-2.15|
71817533|NCT01976364|143137932|OTHER||LS mean difference|0.32|||||TWO_SIDED|95.0|-1.49|2.13||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.13|-1.49|
71849303|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.1||||0.175|TWO_SIDED|95.0|-0.24|0.04|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.04|-0.24|0.175
71849304|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.12||||0.098|TWO_SIDED|95.0|-0.26|0.02|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2|||0.02|-0.26|0.098
71849305|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.12||||0.13|TWO_SIDED|95.0|-0.04|0.27|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.27|-0.04|0.130
71849306|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.375|TWO_SIDED|95.0|-0.08|0.22|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2|||0.22|-0.08|0.375
71849307|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.08||||0.285|TWO_SIDED|95.0|-0.07|0.24|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.24|-0.07|0.285
71849308|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.05||||0.49|TWO_SIDED|95.0|-0.1|0.21|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2|||0.21|-0.10|0.490
71849309|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.345|TWO_SIDED|95.0|-0.23|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.08|-0.23|0.345
71849310|NCT01918033|143212166|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.699|TWO_SIDED|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2|||0.13|-0.19|0.699
71849311|NCT01918033|143212167|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.06||||0.414|TWO_SIDED|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.08|-0.20|0.414
71849312|NCT01918033|143212167|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.281|TWO_SIDED|95.0|-0.22|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2|||0.06|-0.22|0.281
71849313|NCT01702259|143212171|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71849314|NCT01702259|143212172|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71849315|NCT01702259|143212173|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71817534|NCT01976364|143137932|OTHER||LS mean difference|-0.01|||||TWO_SIDED|95.0|-1.89|1.86||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.86|-1.89|
71849316|NCT01702259|143212174|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71849317|NCT03136861|143212182|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0264|TWO_SIDED|95.0|1.08|3.33|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||Average Spinal Pain Score \<4 at Week 8||3.33|1.08|0.0264
71849318|NCT03136861|143212182|SUPERIORITY||Odds Ratio (OR)|1.72||||0.072|TWO_SIDED|95.0|0.95|3.1|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Total Spinal Pain Score \<4 at Week 8||3.10|0.95|0.0720
71849319|NCT03136861|143212182|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0043|TWO_SIDED|95.0|1.31|4.31|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Nocturnal Spinal Pain Score||4.31|1.31|0.0043
71817535|NCT01976364|143137933|OTHER||LS mean difference|0.48|||||TWO_SIDED|95.0|-1.08|2.05||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.05|-1.08|
71817536|NCT01976364|143137933|OTHER||LS mean difference|1.25|||||TWO_SIDED|95.0|-0.49|2.99||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.99|-0.49|
71817537|NCT01976364|143137933|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.91|2.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.31|-0.91|
71849320|NCT03136861|143212183|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0466|TWO_SIDED|95.0|1.01|3.04|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||BASDAI Score \<4 at Week 8||3.04|1.01|0.0466
71849321|NCT01584648|143212184|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.59|0.91|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||0.91|0.59|
71849322|NCT01584648|143212185|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.64|1.02|||||Hazard ratios (HRs) were estimated using a Pike estimator.|||1.02|0.64|
71817538|NCT01976364|143137933|OTHER||LS mean difference|0.2|||||TWO_SIDED|95.0|-1.57|1.96||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.96|-1.57|
71817539|NCT01976364|143137933|OTHER||LS mean difference|1.73|||||TWO_SIDED|95.0|-0.06|3.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.52|-0.06|
71849323|NCT01328756|143212209|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.||||< 0.001
71849324|NCT01137682|143212212|SUPERIORITY||Odds Ratio (OR)|16.63||||0.0006|TWO_SIDED|95.0|3.32||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||3.32|0.0006
71849325|NCT01137682|143212212|SUPERIORITY||Odds Ratio (OR)|23.03|||<|0.0001|TWO_SIDED|95.0|4.72||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||||4.72|<0.0001
71849326|NCT04492475|143212248|SUPERIORITY||Cox Proportional Hazard|0.99||||0.88|TWO_SIDED|95.0|0.87|1.13|||Log Rank|||||1.13|0.87|0.880
71849327|NCT04492475|143212265|SUPERIORITY||Risk Difference (RD)|7.2|||||TWO_SIDED|95.0|0.9|13.4||||||||13.4|0.9|
71849328|NCT04492475|143212265|SUPERIORITY||Risk Difference (RD)|23.6|||||TWO_SIDED|95.0|0.0|43.9||||||||43.9|0.0|
71849329|NCT04492475|143212266|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||||6.0|-3.2|
71849330|NCT04492475|143212266|SUPERIORITY||Risk Difference (RD)|35.8|||||TWO_SIDED|95.0|12.3|54.2||||||||54.2|12.3|
71849331|NCT04492475|143212290|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
71849332|NCT04492475|143212290|SUPERIORITY||Cox Proportional Hazard|0.37|||||TWO_SIDED|95.0|0.21|0.66||||||||0.66|0.21|
71849333|NCT04492475|143212291|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
71849334|NCT04492475|143212291|SUPERIORITY||Cox Proportional Hazard|0.44|||||TWO_SIDED|95.0|0.24|0.82||||||||0.82|0.24|
71849335|NCT04492475|143212292|SUPERIORITY||Cox Proportional Hazard|1.08|||||TWO_SIDED|95.0|0.93|1.26||||||||1.26|0.93|
71817540|NCT01976364|143137934|OTHER||LS mean difference|0.71|||||TWO_SIDED|95.0|-1.01|2.42||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.42|-1.01|
71817541|NCT01976364|143137934|OTHER||LS mean difference|0.34|||||TWO_SIDED|95.0|-1.49|2.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.18|-1.49|
71817542|NCT01976364|143137934|OTHER||LS mean difference|-1.81|||||TWO_SIDED|95.0|-3.7|0.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.09|-3.70|
71849336|NCT04492475|143212292|SUPERIORITY||Cox Proportional Hazard|0.39|||||TWO_SIDED|95.0|0.21|0.72||||||||0.72|0.21|
71849337|NCT04492475|143212293|SUPERIORITY||Cox Proportional Hazard|1.04|||||TWO_SIDED|95.0|0.9|1.19||||||||1.19|0.90|
71849338|NCT04492475|143212294|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.59|1.45||||||This analysis is for Asian participants.||1.45|0.59|
71849339|NCT04492475|143212294|SUPERIORITY||Cox Proportional Hazard|0.92|||||TWO_SIDED|95.0|0.66|1.27||||||This analysis is for Black and African American participants.||1.27|0.66|
71849340|NCT04492475|143212294|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||This analysis is for White participants.||1.21|0.86|
71849341|NCT04492475|143212294|SUPERIORITY||Cox Proportional Hazard|0.84|||||TWO_SIDED|95.0|0.59|1.19||||||This analysis is for Race of Other participants||1.19|0.59|
71849342|NCT04492475|143212295|SUPERIORITY||Cox Proportional Hazard|1.02|||||TWO_SIDED|95.0|0.86|1.19||||||This analysis is for Not Hispanic or Latino participants.||1.19|0.86|
71849343|NCT04492475|143212295|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.65|1.05||||||This analysis is for Hispanic or Latino participants.||1.05|0.65|
71849344|NCT04492475|143212296|SUPERIORITY||Cox Proportional Hazard|0.93|||||TWO_SIDED|95.0|0.78|1.1||||||This analysis is for Male participants.||1.10|0.78|
71849345|NCT04492475|143212296|SUPERIORITY||Cox Proportional Hazard|1.05|||||TWO_SIDED|95.0|0.86|1.29||||||This analysis is for Female participants.||1.29|0.86|
71679434|NCT02045862|142876867|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.37|2.57|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.57|1.37|<0.001
71679435|NCT02045862|142876868|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.001|TWO_SIDED|95.0|1.36|2.43|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||2.43|1.36|<0.001
71679436|NCT02045862|142876868|SUPERIORITY||Odds Ratio (OR)|1.44||||0.014|TWO_SIDED|95.0|1.08|1.92|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.||1.92|1.08|0.014
71679437|NCT02045862|142876869|SUPERIORITY||Odds Ratio (OR)|1.8|||<|0.001|TWO_SIDED|95.0|1.34|2.41|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.41|1.34|<0.001
71679438|NCT02045862|142876869|SUPERIORITY||Odds Ratio (OR)|1.44||||0.019|TWO_SIDED|95.0|1.06|1.95|||Regression, Logistic|||Odds ratio wa from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.95|1.06|0.019
71679439|NCT02045862|142876870|SUPERIORITY||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.26|2.19|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||2.19|1.26|<0.001
71679440|NCT02045862|142876870|SUPERIORITY||Odds Ratio (OR)|1.23||||0.133|TWO_SIDED|95.0|0.94|1.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.||1.62|0.94|0.133
71679441|NCT02045862|142876871|SUPERIORITY||Odds Ratio (OR)|1.55||||0.002|TWO_SIDED|95.0|1.18|2.03|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||2.03|1.18|0.002
71679442|NCT02045862|142876871|SUPERIORITY||Odds Ratio (OR)|1.48||||0.006|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.||1.95|1.12|0.006
71817543|NCT01976364|143137934|OTHER||LS mean difference|-1.76|||||TWO_SIDED|95.0|-3.99|0.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.48|-3.99|
71817544|NCT01976364|143137934|OTHER||LS mean difference|-0.3|||||TWO_SIDED|95.0|-2.3|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.69|-2.30|
71849346|NCT01235936|143212301|OTHER|The primary endpoint was compared using the Wilcoxon signed-rank test, with an alpha level of 0.05.||||||0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0020
71849347|NCT01235936|143212302|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0156|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0156
71849348|NCT01235936|143212303|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.||||||0.0098|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||0.0098
71849349|NCT01235936|143212304|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0195|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0195
71679443|NCT02045862|142876872|SUPERIORITY||Odds Ratio (OR)|1.68|||<|0.001|TWO_SIDED|95.0|1.24|2.29|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.29|1.24|<0.001
71679444|NCT02045862|142876872|SUPERIORITY||Odds Ratio (OR)|1.29||||0.109|TWO_SIDED|95.0|0.94|1.77|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||1.77|0.94|0.109
71679445|NCT02045862|142876873|SUPERIORITY||Odds Ratio (OR)|1.69|||<|0.001|TWO_SIDED|95.0|1.26|2.25|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.25|1.26|<0.001
71817545|NCT01976364|143137935|OTHER||LS mean difference|-0.68|||||TWO_SIDED|95.0|-2.05|0.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.69|-2.05|
71849350|NCT01235936|143212305|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.8262|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.8262
71849351|NCT01235936|143212311|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.002|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0020
71849352|NCT01235936|143212312|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.2383|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.2383
71849353|NCT01235936|143212313|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
71900038|NCT04964063|143322313|OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-5.72|-4.76|||ANOVA|||||-4.76|-5.72|<.0001
71849354|NCT01235936|143212314|OTHER|The test was based on Wilcoxon signed rank test, with an alpha level of 0.05.|||||=|0.0039|||||||Wilcoxon signed rank test|||Analysis of change from baseline on Day 29||||=0.0039
71849355|NCT03212638|143212367|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|1.04|||||TWO_SIDED|95.0|0.946|1.15||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.15|0.946|
71849356|NCT03212638|143212367|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|1.04|||||TWO_SIDED|95.0|0.944|1.14||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.14|0.944|
71849357|NCT03212638|143212367|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.675|||||TWO_SIDED|95.0|0.617|0.74||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||0.740|0.617|
71849358|NCT03212638|143212368|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.996|||||TWO_SIDED|95.0|0.963|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.963|
71849359|NCT03212638|143212368|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.998|||||TWO_SIDED|95.0|0.995|1.03||||||Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).||1.03|0.995|
71849360|NCT03212638|143212368|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.973|||||TWO_SIDED|95.0|0.936|1.01||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.01|0.936|
71849361|NCT03212638|143212369|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.996|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.996|
71849362|NCT03212638|143212369|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||TWO_SIDED|95.0|0.966|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).||1.03|0.966|
71849363|NCT03212638|143212369|EQUIVALENCE|0.80, 1.25 as the bioequivalence boundaries|ratio|0.978|||||TWO_SIDED|95.0|0.941|1.02||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.||1.02|0.941|
71849364|NCT01528605|143212397|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
71849365|NCT01528605|143212398|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference||||<0.05
71849366|NCT01528605|143212399|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||"The null hypothesis is no group difference"||||>0.05
71849367|NCT02326220|143212414|SUPERIORITY||H-L estimate of median difference|0.75|||<|0.0001|TWO_SIDED|95.0|0.667|0.833||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|"Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI.~p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS."||0.833|0.667|< 0.0001
71849368|NCT02326220|143212415|SUPERIORITY||Least Square (LS) Mean Difference|-55.3|STANDARD_ERROR_OF_MEAN|3.9|<|0.0001|TWO_SIDED|95.0|-63.0|-47.5||Threshold for significance at 0.05 level.|MMRM|MMRM: Mixed-effect model with repeated measures|Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-47.5|-63.0|< 0.0001
71849369|NCT02326220|143212416|SUPERIORITY||H-L estimate of median difference|0.5|||<|0.0001|TWO_SIDED|95.0|0.5|1.0||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.000|0.500|<.0001
71849370|NCT02326220|143212417|SUPERIORITY||LS Mean Difference|-44.0|||<|0.0001|TWO_SIDED|95.0|-51.3|-36.6||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-36.6|-51.3|< 0.0001
71849371|NCT02326220|143212418|SUPERIORITY||LS Mean Difference|-50.0|||<|0.0001|TWO_SIDED|95.0|-57.3|-42.7||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.7|-57.3|< 0.0001
71849372|NCT02326220|143212419|SUPERIORITY||LS Mean Difference|-39.4|||<|0.0001|TWO_SIDED|95.0|-45.6|-33.2||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-33.2|-45.6|< 0.0001
71849373|NCT02326220|143212420|SUPERIORITY||LS Mean Difference|4.2||||0.3012|TWO_SIDED|95.0|-3.9|12.3||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.3|-3.9|0.3012
71849374|NCT02699099|143212437|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
71900039|NCT04964063|143322314|OTHER||Mean Difference (Final Values)|-5.63|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-6.12|-5.14|||ANOVA|||||-5.14|-6.12|<.0001
71900040|NCT04964063|143322315|OTHER||Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-6.72|-5.77|||ANOVA|||||-5.77|-6.72|<.0001
71900041|NCT04964063|143322317|OTHER||Mean Difference (Final Values)|-5.25|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-6.06|-4.44|||ANOVA|||||-4.44|-6.06|<.0001
71817546|NCT01976364|143137935|OTHER||LS mean difference|-1.13|||||TWO_SIDED|95.0|-2.57|0.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.31|-2.57|
71817547|NCT01976364|143137935|OTHER||LS mean difference|-0.81|||||TWO_SIDED|95.0|-2.17|0.56||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.56|-2.17|
71817548|NCT01976364|143137935|OTHER||LS mean difference|0.01|||||TWO_SIDED|95.0|-1.54|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-1.54|
71817549|NCT01976364|143137935|OTHER||LS mean difference|0.04|||||TWO_SIDED|95.0|-1.46|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-1.46|
71817550|NCT01976364|143137936|OTHER||LS mean difference|-0.36|||||TWO_SIDED|95.0|-2.06|1.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.35|-2.06|
71849375|NCT02699099|143212442|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rate of the anti-measles antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|2.05|||||TWO_SIDED|95.0|-1.29|5.89|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||5.89|-1.29|
71900042|NCT04964063|143322318|OTHER||Mean Difference (Final Values)|-8.52|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-9.32|-7.72|||ANOVA|||||-7.72|-9.32|<.0001
71900043|NCT04964063|143322319|OTHER||Mean Difference (Final Values)|-10.55|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-11.35|-9.75|||ANOVA|||||-9.75|-11.35|<.0001
71900044|NCT04964063|143322320|OTHER||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-12.41|-10.79|||ANOVA|||||-10.79|-12.41|<.0001
71900045|NCT04964063|143322321|OTHER||Mean Difference (Final Values)|-12.63|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-13.45|-11.81|||ANOVA|||||-11.81|-13.45|<.0001
71817551|NCT01976364|143137936|OTHER||LS mean difference|-0.86|||||TWO_SIDED|95.0|-2.51|0.79||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.79|-2.51|
71817552|NCT01976364|143137936|OTHER||LS mean difference|-1.71|||||TWO_SIDED|95.0|-3.66|0.23||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.23|-3.66|
71817553|NCT01976364|143137936|OTHER||LS mean difference|-0.47|||||TWO_SIDED|95.0|-2.25|1.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.32|-2.25|
71817554|NCT01976364|143137936|OTHER||LS mean difference|0.95|||||TWO_SIDED|95.0|-0.82|2.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.73|-0.82|
71817555|NCT01976364|143137937|OTHER||LS mean difference|0.78|||||TWO_SIDED|95.0|-1.27|2.82||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.82|-1.27|
71900046|NCT04964063|143322322|OTHER||Mean Difference (Final Values)|-13.88|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-14.69|-13.08|||ANOVA|||||-13.08|-14.69|<.0001
71900047|NCT04964063|143322324|OTHER||Mean Difference (Final Values)|-1.88|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.43|-1.33|||ANOVA|||||-1.33|-2.43|<.0001
71900048|NCT04964063|143322325|OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-3.74|-2.65|||ANOVA|||||-2.65|-3.74|<.0001
71900049|NCT04964063|143322326|OTHER||Mean Difference (Final Values)|-3.98|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-4.53|-3.44|||ANOVA|||||-3.44|-4.53|<.0001
71900050|NCT04964063|143322327|OTHER||Mean Difference (Final Values)|-4.55|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-5.1|-4.0|||ANOVA|||||-4.00|-5.10|<.0001
71900051|NCT04964063|143322328|OTHER||Median Difference (Final Values)|-5.04|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-5.6|-4.48|||ANOVA|||||-4.48|-5.60|<.0001
71900052|NCT04964063|143322329|OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-6.62|-5.53|||ANOVA|||||-5.53|-6.62|<.0001
71900053|NCT04964063|143322331|OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.04||0.1091|TWO_SIDED|95.0|-0.12|0.01|||ANOVA|||||0.01|-0.12|0.1091
71900054|NCT04964063|143322332|OTHER||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.19|-0.06|||ANOVA|||||-0.06|-0.19|<.0001
71900055|NCT04964063|143322333|OTHER||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.23|-0.1|||ANOVA|||||-0.10|-0.23|<.0001
71849376|NCT02699099|143212445|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rates of the anti-rubella antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.5|||||TWO_SIDED|95.0|-1.29|2.78|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||"Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049."||2.78|-1.29|
71849377|NCT02699099|143212448|NON_INFERIORITY|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seropositivity rates of the anti-yellow fever antibody , being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.55|||||TWO_SIDED|95.0|-2.3|3.65|||Miettinen and Nurminen method|Miettinen and Nurminen method was used to construct 95%CI for difference between groups||Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.||3.65|-2.30|
71849378|NCT02699099|143212474|NON_INFERIORITY|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.07|||ANOVA|||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.||1.07|0.81|
71849379|NCT03659136|143212493|OTHER||Hazard Ratio (HR)|1.19||||0.6534|TWO_SIDED|95.0|0.55|2.59|||Log-rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior (CDK) 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||2.59|0.55|0.6534
71849380|NCT03659136|143212494|OTHER||Hazard Ratio (HR)|0.5||||0.1797|TWO_SIDED|95.0|0.18|1.4|||Log rank test|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+Everolimus+Exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.40|0.18|0.1797
71849381|NCT03659136|143212495|OTHER||Odds Ratio (OR)|1.31||||0.4932|TWO_SIDED|95.0|0.6|2.86|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||2.86|0.60|0.4932
71849382|NCT03659136|143212497|OTHER||Odds Ratio (OR)|1.2||||0.7759|TWO_SIDED|95.0|0.34|4.43|||Regression, Logistic|Logistic regression model adjusted for presence of baseline bone-only metastases, prior CDK 4/6 inhibitor treatment and menopause status.|Comparison vs. Placebo+everolimus+exemestane. An odds ratio \>1 indicates a benefit to the xentuzumab arm.|||4.43|0.34|0.7759
71849383|NCT03659136|143212498|OTHER||Cox Proportional Hazard|0.97||||0.9279|TWO_SIDED|95.0|0.54|1.76|||Log Rank|Two-sided log-rank test stratified for presence of baseline bone-only metastases, prior CDK4/6 inhibitor treatment and menopause status.|Comparison versus Placebo+everolimus+exemestane.|Cox proportional hazards model stratified for presence of baseline bone-only metastases, prior cyclin-dependent kinase (CDK) 4/6 inhibitor treatment and menopause status.||1.76|0.54|0.9279
71849384|NCT00413283|143212501|SUPERIORITY_OR_OTHER|||||||0.972|||||||Satterthwaite t-test|||||||0.972
71849385|NCT00413283|143212501|SUPERIORITY_OR_OTHER|||||||0.725|||||||Satterthwaite t-test|||||||0.725
71849386|NCT00413283|143212501|SUPERIORITY_OR_OTHER|||||||0.312|||||||Satterthwaite t-test|||||||0.312
71849387|NCT00413283|143212502|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71849388|NCT00413283|143212502|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71849389|NCT00413283|143212502|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71679446|NCT02045862|142876873|SUPERIORITY||Odds Ratio (OR)|1.62|||<|0.001|TWO_SIDED|95.0|1.22|2.16|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.||2.16|1.22|<0.001
71817556|NCT01976364|143137937|OTHER||LS mean difference|-0.38|||||TWO_SIDED|95.0|-2.46|1.71||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.71|-2.46|
71817557|NCT01976364|143137937|OTHER||LS mean difference|-0.57|||||TWO_SIDED|95.0|-2.72|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.57|-2.72|
71679447|NCT02045862|142876874|SUPERIORITY||Odds Ratio (OR)|1.99|||<|0.001|TWO_SIDED|95.0|1.5|2.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.62|1.50|<0.001
71817558|NCT01976364|143137937|OTHER||LS mean difference|0.28|||||TWO_SIDED|95.0|-1.81|2.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.36|-1.81|
71817559|NCT01976364|143137937|OTHER||LS mean difference|0.53|||||TWO_SIDED|95.0|-1.58|2.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.63|-1.58|
71817560|NCT01976364|143137938|OTHER||LS mean difference|-1.67|||||TWO_SIDED|95.0|-3.67|0.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.32|-3.67|
71817561|NCT01976364|143137938|OTHER||LS mean difference|-0.61|||||TWO_SIDED|95.0|-2.86|1.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.63|-2.86|
71817562|NCT01976364|143137938|OTHER||LS mean difference|-0.09|||||TWO_SIDED|95.0|-2.27|2.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.09|-2.27|
71817563|NCT01976364|143137938|OTHER||LS mean difference|0.73|||||TWO_SIDED|95.0|-1.49|2.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.95|-1.49|
71849390|NCT00413283|143212503|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71817564|NCT01976364|143137938|OTHER||LS mean difference|-0.79|||||TWO_SIDED|95.0|-3.1|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.53|-3.10|
71817565|NCT01976364|143137939|OTHER||LS mean difference|0.93|||||TWO_SIDED|95.0|-0.95|2.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.81|-0.95|
71817566|NCT01976364|143137939|OTHER||LS mean difference|0.11|||||TWO_SIDED|95.0|-1.72|1.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.95|-1.72|
71817567|NCT01976364|143137939|OTHER||LS mean difference|-0.25|||||TWO_SIDED|95.0|-2.4|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.90|-2.40|
71679448|NCT02045862|142876874|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.35|2.36|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.||2.36|1.35|<0.001
71817568|NCT01976364|143137939|OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-0.93|3.07||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||3.07|-0.93|
71817569|NCT01976364|143137939|OTHER||LS mean difference|0.38|||||TWO_SIDED|95.0|-1.62|2.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.38|-1.62|
71817570|NCT01976364|143137940|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.5|-0.9|
71849391|NCT00413283|143212503|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71849392|NCT00413283|143212503|SUPERIORITY_OR_OTHER|||||||0.342|||||||Fisher Exact|||||||0.342
71849393|NCT00413283|143212504|SUPERIORITY_OR_OTHER|||||||0.454|||||||Satterthwaite t-test|||||||0.454
71849394|NCT00413283|143212504|SUPERIORITY_OR_OTHER|||||||0.101|||||||Satterthwaite t-test|||||||0.101
71849395|NCT00413283|143212504|SUPERIORITY_OR_OTHER|||||||0.199|||||||Satterthwaite t-test|||||||0.199
71817571|NCT01976364|143137940|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-1.1|2.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.2|-1.1|
71817572|NCT01976364|143137940|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-2.4|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.0|-2.4|
71817573|NCT01976364|143137940|OTHER||LS mean difference|1.1|||||TWO_SIDED|95.0|-0.8|2.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.9|-0.8|
71817574|NCT01976364|143137940|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-1.1|2.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.6|-1.1|
71817575|NCT01976364|143137941|OTHER||LS mean difference|0.4|||||TWO_SIDED|95.0|-0.4|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-0.4|
71817576|NCT01976364|143137941|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.7|-1.0|
71849396|NCT00413283|143212505|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
71849397|NCT00413283|143212505|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71849398|NCT00413283|143212505|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||||||0.662
71849399|NCT00246129|143212507|SUPERIORITY|||||||0.467|||||||Log Rank|||||||0.467
71849400|NCT00246129|143212508|SUPERIORITY|||||||0.138|||||||Log Rank|||||||0.138
71849401|NCT02005172|143212527|EQUIVALENCE|The primary analysis used the TOST procedure for equivalence. A difference of less than 10% between devices on the proportion of diagnostic days during the monitoring period was considered to be equivalent. We hypothesized that the percentage of diagnostic days for the ELR and the KM would be 20% and 15%, respectively.||||||||||||||||For the primary endpoint, equivalence testing using the two one-sided test procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence.|"Descriptive statistics (means, standard deviation (SD), percentages) were used to summarize the demographic and clinical characteristics of the patients. The total number of tracings and the percentage of tracings with arrhythmias for each device were also calculated.~For the primary endpoint, equivalence testing using the two one-sided test (TOST) procedure was used to compare the proportion of (unpaired) days in which a diagnostic recording was made with each device during the monitoring period. Patients were asked to use both devices for the same duration. For the purpose of this study, a difference of less than 10% between devices on the rate of detection of arrhythmias was taken to indicate equivalence. The primary hypothesis was that the KM"|||
71849402|NCT01853384|143212531|SUPERIORITY_OR_OTHER|||||||0.5348||||||Analysis adjusted for sites, with significance being at P \< 0.05|Cochran-Mantel-Haenszel|||||||.5348
71849403|NCT01853384|143212532|SUPERIORITY_OR_OTHER|||||||0.9456|||||||Regression, Cox|||||||.9456
71849404|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.6194||||||Treatment Week 01|Cochran-Mantel-Haenszel|||||||.6194
71849405|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.793||||||Treatment Week 02|Cochran-Mantel-Haenszel|||||||.7930
71900056|NCT04964063|143322334|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.24|-0.11|||ANOVA|||||-0.11|-0.24|<.0001
71900057|NCT04964063|143322335|OTHER||Median Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.26|-0.13|||ANOVA|||||-0.13|-0.26|<.0001
71849406|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.3362||||||Treatment Week 03|Cochran-Mantel-Haenszel|||||||0.3362
71849407|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.5263||||||Treatment Week 04|Cochran-Mantel-Haenszel|||||||0.5263
71849408|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.1997||||||Treatment Week 05|Cochran-Mantel-Haenszel|||||||0.1997
71900058|NCT04964063|143322336|OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.31|-0.18|||ANOVA|||||-0.18|-0.31|<.0001
71849409|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.1617||||||Treatment Week 06|Cochran-Mantel-Haenszel|||||||0.1617
71849410|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.2611||||||Treatment Week 07|Cochran-Mantel-Haenszel|||||||0.2611
71849411|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.7232||||||Treatment Week 08|Cochran-Mantel-Haenszel|||||||0.7232
71849412|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.4405||||||Treatment Week 09|Cochran-Mantel-Haenszel|||||||0.4405
71849413|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.3516||||||Treatment Week 10|Cochran-Mantel-Haenszel|||||||0.3516
71849414|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.2821||||||Treatment Week 11|Cochran-Mantel-Haenszel|||||||0.2821
71849415|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.3722||||||Treatment Week 12|Cochran-Mantel-Haenszel|||||||0.3722
71849416|NCT01853384|143212534|SUPERIORITY_OR_OTHER|||||||0.5348||||||Week 12 - Primary Endpoint|Cochran-Mantel-Haenszel|||||||0.5348
71849417|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.5909||||||Week 01|ANCOVA|||||||0.5909
71849418|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.8234||||||Week 02|ANCOVA|||||||0.8234
71849419|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.1556||||||Week 03|ANCOVA|||||||0.1556
71849420|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.3487||||||Week 04|ANCOVA|||||||0.3487
71849421|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.1064||||||Week 05|ANCOVA|||||||0.1064
71849422|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.2888||||||Week 06|ANCOVA|||||||0.2888
71849423|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.6095||||||Week 07|ANCOVA|||||||0.6095
71900059|NCT04964063|143322338|OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.95|-1.45|||ANOVA|||||-1.45|-1.95|<.0001
71900060|NCT04964063|143322339|OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-2.94|-2.44|||ANOVA|||||-2.44|-2.94|<.0001
71900061|NCT04964063|143322340|OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.35|-2.84|||ANOVA|||||-2.84|-3.35|<.0001
71679449|NCT02045862|142876875|SUPERIORITY||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.46|2.54|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.54|1.46|<0.001
71817577|NCT01976364|143137941|OTHER||LS mean difference|-0.7|||||TWO_SIDED|95.0|-1.6|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-1.6|
71817578|NCT01976364|143137941|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
71817579|NCT01976364|143137941|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.8|-0.9|
71849424|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.1566||||||Week 08|ANCOVA|||||||0.1566
71849425|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.4216||||||Week 09|ANCOVA|||||||0.4216
71817580|NCT01976364|143137942|OTHER||LS mean difference|0.5|||||TWO_SIDED|95.0|-0.6|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-0.6|
71817581|NCT01976364|143137942|OTHER||LS mean difference|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.7|-0.3|
71849426|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.8166||||||Week10|ANCOVA|||||||0.8166
71849427|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.9114||||||Week 11|ANCOVA|||||||0.9114
71849428|NCT01853384|143212536|SUPERIORITY_OR_OTHER|||||||0.9733||||||Week 12|ANCOVA|||||||0.9733
71849429|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.7439||||||Week 01|ANCOVA|||||||0.7439
71849430|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.6992||||||Week 02|ANCOVA|||||||0.6992
71849431|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.0867||||||Week 03|ANCOVA|||||||0.0867
71849432|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.5739||||||Week 04|ANCOVA|||||||0.5739
71849433|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.6497||||||Week 05|ANCOVA|||||||0.6497
71849434|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.1427||||||Week 06|ANCOVA|||||||0.1427
71849435|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.0682||||||Week 07|ANCOVA|||||||0.0682
71849436|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.0161||||||Week 08|ANCOVA|||||||0.0161
71849437|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.0973||||||Week 09|ANCOVA|||||||0.0973
71849438|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.4661||||||Week 10|ANCOVA|||||||0.4661
71849439|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.601||||||Week 11|ANCOVA|||||||0.6010
71849440|NCT01853384|143212537|SUPERIORITY_OR_OTHER|||||||0.3369||||||Week 12|ANCOVA|||||||0.3369
71849441|NCT01205126|143212538|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.6||0.855|TWO_SIDED|95.0|-1.3|1.1||P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|ANCOVA|||||1.1|-1.3|0.855
71849442|NCT01205126|143212539|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.615|TWO_SIDED|95.0|-1.0|0.6|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.6|-1.0|0.615
71849443|NCT01205126|143212540|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.621|TWO_SIDED|95.0|-1.1|0.7|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||0.7|-1.1|0.621
71849444|NCT01205126|143212541|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.832|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.||||||0.832
71849445|NCT01205126|143212542|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.304|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29||||||0.304
71849446|NCT01205126|143212543|SUPERIORITY_OR_OTHER|||||||0.276|||||||rank sum test, 2 sided|||||||0.276
71849447|NCT03331978|143212544|SUPERIORITY||Mean Difference (Net)|6.89|STANDARD_ERROR_OF_MEAN|3.91||0.08|TWO_SIDED|95.0|-0.82|14.61|||Regression, Linear|Model is adjusted for participant sex, which was found to be significantly associated with adherence in a similar repeated measures model.|Values entered are for regression coefficient for intervention indicator (versus control) and represents the adjusted difference across all follow-up time points.|Tested with repeated measures linear regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and continuous adherence measured at baseline. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||14.61|-0.82|.08
71900062|NCT04964063|143322341|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-3.69|-3.19|||ANOVA|||||-3.19|-3.69|<.0001
71900063|NCT04964063|143322342|OTHER||Median Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.06|-3.55|||ANOVA|||||-3.55|-4.06|<.0001
71900064|NCT04964063|143322343|OTHER||Mean Difference (Final Values)|-4.26|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-4.51|-4.0|||ANOVA|||||-4.00|-4.51|<.0001
71817582|NCT01976364|143137942|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-1.0|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.2|-1.0|
71817583|NCT01976364|143137942|OTHER||LS mean difference|1.2|||||TWO_SIDED|95.0|0.0|2.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.3|0.0|
71817584|NCT01976364|143137942|OTHER||LS mean difference|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.9|-0.3|
71849448|NCT03331978|143212545|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0257|TWO_SIDED|95.0|1.09|3.6||Per above, p-value is from repeated measures logistic regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where all 6 past-month post-intervention measurements of adherence were stacked together such that each participant could contribute up to 6 records. Standard errors were adjusted for clustering on participant, and weights for presence of data were used. Fixed effects were an intervention indicator and baseline dichotomous adherence. Model included all participants with adherence data (a) at baseline and (b) at least one follow-up month.||3.60|1.09|.0257
71849449|NCT03331978|143212546|SUPERIORITY||Odds Ratio (OR)|1.82||||0.26|TWO_SIDED|95.0|0.64|5.18||As mentioned above, p-value comes from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention measurements were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for presence of viral suppression data were used. Fixed effects were an intervention indicator and baseline viral suppression. Model included all viral suppression data (a) at baseline and (b) close to either of the two follow-up surveys.||5.18|0.64|.26
71849450|NCT03331978|143212547|SUPERIORITY||Odds Ratio (OR)|0.57||||0.05|TWO_SIDED|95.0|0.32|1.0||As mentioned above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant.|Regression, Logistic||Odds ratio is for intervention indicator (versus controls).|Tested with repeated measures logistic regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||1.00|0.32|.05
71849451|NCT03331978|143212548|SUPERIORITY||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.091||0.0199|TWO_SIDED|95.0|-0.395|-0.034||As described above, p-value is from repeated measures regression with standard errors adjusted for clustering on participant|Regression, Linear||Estimation parameter is the regression coefficient for intervention indicator (vs. control) and represents the adjusted difference across both follow-up time points.|Tested with repeated measures linear regression where both post-intervention responses were stacked together such that each participant could contribute up to 2 records. Standard errors were adjusted for clustering on participant, and weights for follow-up response were used. Fixed effects were an intervention indicator and baseline stigma. Model included all participants with responses (a) at baseline and (b) at least one of the two follow-up surveys.||-0.034|-0.395|.0199
71849452|NCT00805792|143212557|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
71849453|NCT00805792|143212558|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
71849454|NCT00805792|143212559|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).||||<.001
71900065|NCT01035606|143322345|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<.01
71900066|NCT01035606|143322346|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71900067|NCT03350750|143322347|SUPERIORITY||ANCOVA Model Effect (Open vs. Closed)|0.22||||0.071|TWO_SIDED|95.0|-0.02|0.46|||ANCOVA||This is the coefficient for an indicator variable comparing the Open versus Closed shunt group, in a linear regression model with Month 4 gait velocity as the outcome and Baseline gait velocity included as a predictor along with treatment.|||0.46|-0.02|0.071
71900068|NCT03350750|143322348|SUPERIORITY|||||||0.337|||||||ANCOVA|||||||0.337
71900069|NCT03350750|143322349|SUPERIORITY|||||||0.007|||||||ANCOVA|||||||0.007
71817585|NCT01976364|143137943|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71817586|NCT01976364|143137943|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71900070|NCT03350750|143322350|SUPERIORITY|||||||0.201|||||||ANCOVA|||||||0.201
71900071|NCT03350750|143322351|SUPERIORITY|||||||0.172|||||||ANCOVA|||||||0.172
71900072|NCT03350750|143322352|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.780
71900073|NCT03350750|143322353|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71900074|NCT03350750|143322354|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.240
71817587|NCT01976364|143137943|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71817588|NCT01976364|143137943|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71817589|NCT01976364|143137943|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
71817590|NCT01976364|143137944|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|0.0|
71817591|NCT01976364|143137944|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
71817592|NCT01976364|143137944|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
71817593|NCT01976364|143137944|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
71849455|NCT01836523|143212561|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.2|||||TWO_SIDED|95.0|-0.32|-0.07||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.07|-0.32|
71817594|NCT01976364|143137944|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
71817595|NCT01976364|143137945|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
71817596|NCT01976364|143137945|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71849456|NCT01836523|143212561|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.15|||||TWO_SIDED|95.0|-0.27|-0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-0.03|-0.27|
71849457|NCT01836523|143212561|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper bound of 95% confidence interval was \<0.3.|Treatment difference|-0.09|||||TWO_SIDED|95.0|-0.21|0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||0.03|-0.21|
71849458|NCT01836523|143212562|SUPERIORITY_OR_OTHER||Treatment difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-5.65|-4.16|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-4.16|-5.65|<0.0001
71900075|NCT03350750|143322355|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
71900076|NCT03350750|143322356|SUPERIORITY|||||||0.019|||||||t-test, 2 sided|||||||0.019
71900077|NCT03350750|143322357|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.040
71900078|NCT03350750|143322358|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
71817597|NCT01976364|143137945|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|0.0|
71817598|NCT01976364|143137945|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
71817599|NCT01976364|143137945|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71849459|NCT01836523|143212562|SUPERIORITY_OR_OTHER||Treatment difference|-3.55|||<|0.0001|TWO_SIDED|95.0|-4.29|-2.81|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-2.81|-4.29|<0.0001
71849460|NCT01836523|143212562|SUPERIORITY_OR_OTHER||Treatment difference|-2.19|||<|0.0001|TWO_SIDED|95.0|-2.91|-1.47|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.||-1.47|-2.91|<0.0001
71849461|NCT01836523|143212563|SUPERIORITY_OR_OTHER||Treatment ratio|0.92|||<|0.0001|TWO_SIDED|95.0|0.88|0.96|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.96|0.88|<0.0001
71849462|NCT01836523|143212563|SUPERIORITY_OR_OTHER||Treatment ratio|0.95||||0.0148|TWO_SIDED|95.0|0.91|0.99|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||0.99|0.91|0.0148
71849463|NCT01836523|143212563|SUPERIORITY_OR_OTHER||Treatment ratio|1.0||||0.9615|TWO_SIDED|95.0|0.96|1.04|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c \< 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and \>27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis||1.04|0.96|0.9615
71849464|NCT01836523|143212564|SUPERIORITY_OR_OTHER||Rate ratio|1.31||||0.0081|TWO_SIDED|95.0|1.07|1.59|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.59|1.07|0.0081
71849465|NCT01836523|143212564|SUPERIORITY_OR_OTHER||Rate ratio|1.27||||0.0219|TWO_SIDED|95.0|1.03|1.55|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.55|1.03|0.0219
71849466|NCT01836523|143212564|SUPERIORITY_OR_OTHER||Rate ratio|1.17||||0.1079|TWO_SIDED|95.0|0.97|1.43|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).||1.43|0.97|0.1079
71849467|NCT00813709|143212568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.555||||0.002|TWO_SIDED|95.0|0.378|0.816|||Log Rank|||||0.816|0.378|0.002
71849468|NCT00813709|143212568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.573||||0.006|TWO_SIDED|95.0|0.391|0.839|||Log Rank|||||0.839|0.391|0.006
71849469|NCT00813709|143212568|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993||||0.941|TWO_SIDED|95.0|0.654|1.51|||Log Rank|||||1.510|0.654|0.941
71849470|NCT00813709|143212569|SUPERIORITY_OR_OTHER|||||||0.205||95.0|||||Log Rank|||||||0.205
71849471|NCT00813709|143212569|SUPERIORITY_OR_OTHER|||||||0.263||95.0|||||Log Rank|||||||0.263
71849472|NCT00813709|143212569|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||Log Rank|||||||0.629
71849473|NCT02753075|143212592|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|0.09||||0.829|TWO_SIDED|95.0|-0.289|0.461||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.461|-0.289|0.8290
71900079|NCT03350750|143322359|SUPERIORITY|||||||0.235|||||||Fisher Exact|Fisher's exact test with a mid-p-value correction||||||0.235
71900080|NCT01849250|143322362|SUPERIORITY|||||||0.5|||||||ANCOVA|||||||.50
71849474|NCT02753075|143212592|SUPERIORITY_OR_OTHER||LS mean difference|-0.01||||0.9993|TWO_SIDED|95.0|-0.372|0.362||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett's multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.362|-0.372|0.9993
71849475|NCT02753075|143212593|SUPERIORITY_OR_OTHER||LS mean difference|0.09||||0.5892|TWO_SIDED|95.0|-0.242|0.424|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.424|-0.242|0.5892
71900081|NCT01849250|143322365|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||.19
71900082|NCT01849250|143322366|SUPERIORITY|||||||0.52|||||||ANOVA|||||||.52
71900083|NCT01849250|143322367|SUPERIORITY|||||||0.12|||||||ANCOVA|||||||.12
71900084|NCT00064662|143322417|SUPERIORITY_OR_OTHER||Other|0.0||||0.01||95.0|||||Log Rank|||Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.||||0.01
71900085|NCT00064662|143322418|SUPERIORITY_OR_OTHER||Chi-square|16.2|||<|0.001||95.0|||||Log Rank|||Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.||||<0.001
71900086|NCT00064662|143322418|SUPERIORITY_OR_OTHER||Other|0.0|||<|0.0001||95.0|||||Kalpan Meier (Wald statistic)|||Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.||||<0.0001
71900087|NCT02650284|143322438|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.46||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.46
71900088|NCT02650284|143322438|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.23||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 6-week timepoint.||||0.23
71900089|NCT02650284|143322438|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.1||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 3-month timepoint.||||0.10
71817600|NCT01976364|143137946|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
71817601|NCT01976364|143137946|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71817602|NCT01976364|143137946|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.1|
71817603|NCT01976364|143137946|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71817604|NCT01976364|143137946|OTHER||LS mean difference|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-0.1|
71817605|NCT01976364|143137947|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
71817606|NCT01976364|143137947|OTHER||LS mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
71849476|NCT02753075|143212594|SUPERIORITY_OR_OTHER||LS mean difference|0.14||||0.2825|TWO_SIDED|95.0|-0.116|0.396|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.396|-0.116|0.2825
71849477|NCT02753075|143212594|SUPERIORITY_OR_OTHER||LS mean difference|0.03||||0.8448|TWO_SIDED|95.0|-0.229|0.28|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.280|-0.229|0.8448
71900090|NCT02650284|143322438|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 12-month timepoint.||||0.98
71679450|NCT02045862|142876875|SUPERIORITY||Odds Ratio (OR)|1.59||||0.001|TWO_SIDED|95.0|1.2|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.||2.09|1.20|0.001
71849478|NCT02753075|143212594|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.3784|TWO_SIDED|95.0|-0.141|0.371|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.371|-0.141|0.3784
71817607|NCT01976364|143137947|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.1|-0.2|
71817608|NCT01976364|143137947|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.3|
71817609|NCT01976364|143137947|OTHER||LS mean difference|-0.1|||||TWO_SIDED|95.0|-0.2|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.0|-0.2|
71817610|NCT01976364|143137948|OTHER||LS mean difference|-2.9|||||TWO_SIDED|95.0|-6.2|0.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.4|-6.2|
71849479|NCT02753075|143212595|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.1688|TWO_SIDED|95.0|-10.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-10.00|0.1688
71900091|NCT02650284|143322438|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.5||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at 24-month timepoint.||||0.50
71817611|NCT01976364|143137948|OTHER||LS mean difference|-1.5|||||TWO_SIDED|95.0|-5.8|2.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||2.7|-5.8|
71817612|NCT01976364|143137948|OTHER||LS mean difference|-6.3|||||TWO_SIDED|95.0|-10.2|-2.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||-2.4|-10.2|
71900092|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.59||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D Index preoperatively between both groups.||||0.59
71900093|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 3-months between both groups.||||0.90
71900094|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 12-months between both groups.||||0.57
71900095|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.49||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D index at 24-months between both groups.||||0.49
71900096|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means||||||0.65||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS preoperatively between both groups.||||0.65
71900097|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.3||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 3-months between both groups.||||0.30
71900098|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 12-months between both groups.||||0.06
71900099|NCT02650284|143322439|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.44||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare EQ-5D VAS at 24-months between both groups.||||0.44
71900100|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.97||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest preoperatively between both groups.||||0.97
71900101|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.45||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 3-months between both groups.||||0.45
71900102|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.64||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 12-months between both groups.||||0.64
71900103|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.19||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Rest at 24-months between both groups.||||0.19
71817613|NCT01976364|143137948|OTHER||LS mean difference|-2.8|||||TWO_SIDED|95.0|-7.3|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||1.6|-7.3|
71817614|NCT01976364|143137948|OTHER||LS mean difference|-4.9|||||TWO_SIDED|95.0|-9.9|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.||0.2|-9.9|
71817615|NCT02318719|143137962|SUPERIORITY||Difference of least square mean|-0.41||||0.017|TWO_SIDED|95.0|-0.74|-0.07||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 15 mg/day at Week 14||-0.07|-0.74|0.0170
71900104|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation preoperatively between both groups.||||0.57
71900105|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.98||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 3-months between both groups.||||0.98
71900106|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.58||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 12-months between both groups.||||0.58
71849480|NCT02753075|143212595|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.438|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.4380
71849481|NCT02753075|143212595|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.5693|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.5693
71849482|NCT02753075|143212596|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7789|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7789
71849483|NCT02753075|143212596|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.7214|TWO_SIDED|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||0.000|-5.000|0.7214
71849484|NCT02753075|143212596|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.896|TWO_SIDED|95.0|-5.0|5.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.|||5.000|-5.000|0.8960
71849485|NCT02753075|143212597|SUPERIORITY_OR_OTHER||LS mean difference|0.45||||0.0978|TWO_SIDED|95.0|-0.084|0.987|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.987|-0.084|0.0978
71849486|NCT02753075|143212597|SUPERIORITY_OR_OTHER||LS mean difference|0.2||||0.4607|TWO_SIDED|95.0|-0.333|0.732|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.732|-0.333|0.4607
71849487|NCT02753075|143212597|SUPERIORITY_OR_OTHER||LS mean difference|0.25||||0.3542|TWO_SIDED|95.0|-0.283|0.787|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.787|-0.283|0.3542
71849488|NCT02753075|143212598|SUPERIORITY_OR_OTHER||LS mean difference|0.02||||0.9474|TWO_SIDED|95.0|-0.665|0.711|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.711|-0.665|0.9474
71849489|NCT02753075|143212598|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.7987|TWO_SIDED|95.0|-0.76|0.586|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.586|-0.760|0.7987
71849490|NCT02753075|143212598|SUPERIORITY_OR_OTHER||LS mean difference|0.11||||0.7525|TWO_SIDED|95.0|-0.578|0.798|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.798|-0.578|0.7525
71849491|NCT04471805|143212599|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
71849492|NCT04471805|143212600|SUPERIORITY||||||<|0.05||||||Post hoc analyses (paired t-tests and Bonferroni correction) and effect size (Cohen's d) were calculated to clarify significant main effects and interactions.|ANOVA|Normality and sphericity evaluated with Shapiro-Wilk test and Mauchly's test. Greenhouse-Geisser corrections used when sphericity was violated.||||||<0.05
71849493|NCT01163214|143212606|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
71849494|NCT01163214|143212606|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.58
71849495|NCT01163214|143212607|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||t-test, 2 sided|||||||0.76
71849496|NCT01163214|143212607|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.59
71849497|NCT01163214|143212608|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for intraoperative narcotic use.||||<0.001
71817616|NCT02318719|143137962|SUPERIORITY||Difference of least square means|-0.47||||0.0058|TWO_SIDED|95.0|-0.81|-0.14||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 20 mg/day at Week 14||-0.14|-0.81|0.0058
71817617|NCT02318719|143137962|SUPERIORITY||Difference of least square means|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.44||DS-5565 20 mg and 30 mg vs placebo were tested at level of 0.025. If both were significant, 15 mg was tested at 0.05. If neither were significant, 15 mg was no longer tested. If either 20 mg or 30 mg was significant, 15 mg was tested at 0.025.|Mixed Models Analysis|||Placebo vs DS-5565 30 mg/day at Week 14||-0.44|-1.10|<0.0001
71817618|NCT00423293|143137985|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|95.0||||One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).|Chi-squared|||The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 \[NCT00003596\] had a 77% rate of \>= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)||||0.50
71817619|NCT00423293|143137987|SUPERIORITY|||||||0.5|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.5
71817620|NCT00423293|143137987|SUPERIORITY|||||||0.18|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.18
71849498|NCT01163214|143212608|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on day of surgery as needed.||||<0.001
71817621|NCT00423293|143137987|SUPERIORITY|||||||0.032|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.032
71817622|NCT00423293|143137987|SUPERIORITY|||||||0.1|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.10
71817623|NCT00423293|143137987|SUPERIORITY|||||||0.12|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.12
71817624|NCT00423293|143137987|SUPERIORITY|||||||0.23|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.||||0.23
71817625|NCT01863043|143138070|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||||||0.27
71817626|NCT01863043|143138071|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
71817627|NCT01863043|143138072|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
71817628|NCT01863043|143138073|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
71817629|NCT01863043|143138074|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71817630|NCT01863043|143138075|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71817631|NCT01863043|143138076|SUPERIORITY|||||||0.59|||||||Accelerated failure time regression mode|||||||0.59
71817632|NCT01863043|143138077|SUPERIORITY|||||||0.64|||||||Accelerated failure time regression mode|||||||0.64
71817633|NCT01863043|143138078|SUPERIORITY|||||||0.95|||||||Accelerated failure time regression mode|||||||0.95
71817634|NCT01863043|143138079|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71817635|NCT01863043|143138080|SUPERIORITY|||||||0.23|||||||Accelerated failure time regression mode|||||||0.23
71817636|NCT01863043|143138081|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
71817637|NCT01863043|143138082|SUPERIORITY|||||||0.01|||||||Accelerated failure time regression mode|||||||0.01
71817638|NCT01863043|143138083|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71817639|NCT01863043|143138084|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71817640|NCT01863043|143138086|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71817641|NCT01863043|143138087|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71817642|NCT01863043|143138088|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71817643|NCT01863043|143138089|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||||||0.43
71817644|NCT01863043|143138090|SUPERIORITY|||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
71817645|NCT01863043|143138091|SUPERIORITY|||||||0.97|||||||Accelerated failure time regression mode|||||||0.97
71817646|NCT01863043|143138092|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
71817647|NCT01863043|143138093|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71817648|NCT01863043|143138094|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71817649|NCT01863043|143138095|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71817650|NCT01863043|143138096|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71817651|NCT01863043|143138097|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
71900107|NCT02650284|143322440|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.16||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare VAS Pain at Mobilisation at 24-months between both groups.||||0.16
71900108|NCT02650284|143322441|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.62||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score preoperatively between both groups.||||0.62
71900109|NCT02650284|143322441|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.06||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 3-months between both groups.||||0.06
71900110|NCT02650284|143322441|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.93||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare New Knee Society Function Score at 24-months between both groups.||||0.93
71900111|NCT02650284|143322442|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.57||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||Comparison between groups at pre-operation timepoint.||||0.57
71817652|NCT01863043|143138098|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||||||0.59
71817653|NCT01863043|143138099|SUPERIORITY|||||||0.888|||||||Mixed Models Analysis|||||||0.888
71900112|NCT02650284|143322442|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.17||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 3-months between both groups.||||0.17
71817654|NCT01863043|143138100|SUPERIORITY|||||||0.694|||||||Regression, Linear|||||||0.694
71817655|NCT01863043|143138101|SUPERIORITY|||||||0.248|||||||general linear mixed model|||||||0.248
71817656|NCT01863043|143138102|SUPERIORITY|||||||0.694|||||||general linear mixed model|||||||0.694
71817657|NCT01863043|143138103|SUPERIORITY|||||||0.195|||||||Regression, Linear|||||||0.195
71817658|NCT03154359|143138126|OTHER|||||||0.197|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.197
71817659|NCT03154359|143138126|OTHER|||||||0.562|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.562
71817660|NCT03154359|143138127|OTHER|||||||0.558|||||||t-test, 2 sided|||||||0.558
71817661|NCT03154359|143138128|OTHER|||||||0.147|||||||t-test, 2 sided|||||||0.147
71817662|NCT03154359|143138129|OTHER|||||||0.495|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.495
71817663|NCT03154359|143138129|OTHER|||||||0.955|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.955
71817664|NCT03154359|143138130|OTHER|||||||0.991|||||||t-test, 2 sided|||||||0.991
71817665|NCT03154359|143138131|OTHER|||||||0.759|||||||t-test, 2 sided|||||||0.759
71817666|NCT03154359|143138132|OTHER|||||||0.456|||||||t-test, 2 sided|||Comparing 6-week responders and 6-week non-responders||||0.456
71817667|NCT03154359|143138132|OTHER|||||||0.822|||||||t-test, 2 sided|||Comparing 18-week responders and 18-week non-responders||||0.822
71817668|NCT03154359|143138133|OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
71817669|NCT03154359|143138134|OTHER|||||||0.539|||||||t-test, 2 sided|||||||0.539
71817670|NCT03154359|143138135|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.130
71817671|NCT03154359|143138136|OTHER|||||||0.652|||||||t-test, 2 sided|||||||0.652
71817672|NCT00872430|143138142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71817673|NCT00872430|143138143|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.||||<0.001
71817674|NCT02951351|143138144|NON_INFERIORITY|By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin.||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
71817675|NCT02951351|143138145|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71817676|NCT02951351|143138146|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||||||0.86
71817677|NCT02951351|143138147|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71817678|NCT02951351|143138148|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71817679|NCT02951351|143138149|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71817680|NCT02951351|143138150|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||||||0.18
71817681|NCT02951351|143138151|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
71817682|NCT01580098|143138177|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.025
71817683|NCT01580098|143138178|SUPERIORITY_OR_OTHER|||||||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Blood pressure: diastolic||||0.182
71817684|NCT00345384|143138203|SUPERIORITY_OR_OTHER||Precentage Difference|41.0||||0.03|TWO_SIDED|95.0|||||t-test, 2 sided||The percentage in opioid use by the dexmedetomidine group in comparison to the placebo for the period of time on study drug is calculated as follows: numerator = 29, denominator = 49.|||||0.03
71817685|NCT00345384|143138203|SUPERIORITY_OR_OTHER||Percentage difference|35.0||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided||A measure of opioid use, weighted for total time on study drug. This is examined by a comparison of the dexmedetomidine group to the placebo group: numerator = 35, denominator = 54.|||||0.04
71817686|NCT00345384|143138204|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||The p-value reported in this table corresponds with the 6 to 16 hour time frame.||||0.02
71817687|NCT00058019|143138218|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Fisher Exact|||||||0.022
71817688|NCT00058019|143138219|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.00
71817689|NCT00058019|143138221|SUPERIORITY_OR_OTHER|||||||0.695|TWO_SIDED|95.0|||||Log Rank|||||||0.695
71817690|NCT00058019|143138222|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED|95.0|||||Log Rank|||||||0.55
71817691|NCT03292146|143138243|SUPERIORITY|||||||0.009|||||||Mixed Models Analysis|||||||0.009
71817692|NCT03292146|143138244|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71817693|NCT03292146|143138245|SUPERIORITY|||||||0.06|||||||Matched pairs|||||||0.06
71817694|NCT03292146|143138245|SUPERIORITY|||||||0.01|||||||Matched pairs|||||||0.01
71817695|NCT00545363|143138248|SUPERIORITY_OR_OTHER||||||=|0.8989|||||||ANOVA|||Statistical analysis was done to compare the participant satisfaction between the Biofeedback and No-feedback arms.||||=0.8989
71817696|NCT00545363|143138249|SUPERIORITY_OR_OTHER||||||=|0.453|||||||ANOVA|||Statistical analysis was done to compare the participant perception between the Biofeedback and No-feedback arms.||||=0.453
71817697|NCT00545363|143138250|SUPERIORITY_OR_OTHER||||||=|0.4917|||||||ANOVA|||Statistical analysis was done to compare the effect of adherence (Yes/No) on percent change from baseline in CTX between the Biofeedback and No-feedback arms.||||=0.4917
71849499|NCT01163214|143212608|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 1 as needed.||||0.17
71849500|NCT01163214|143212608|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 2 as needed.||||0.51
71817698|NCT00366301|143138251|SUPERIORITY_OR_OTHER||Percent Change in Log CRP|20.0|STANDARD_ERROR_OF_MEAN|10.0|<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Adjusted models included terms for baseline HbA1c and weight and change in weight at each time point.||As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. The means at each time point were estimated from a repeated-measures model incorporating all 3 time points. The interventions were assessed by fitting terms corresponding to study drug and treatment arm assignment.||||<0.05
71817699|NCT02354963|143138257|SUPERIORITY|||||||0.302|||||||Wilcoxon (Mann-Whitney)|||||||0.302
71817700|NCT02354963|143138258|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
71817701|NCT02354963|143138259|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71817702|NCT02354963|143138260|SUPERIORITY|||||||0.427|||||||Wilcoxon (Mann-Whitney)|||||||0.427
71817703|NCT02354963|143138261|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
71817704|NCT02354963|143138262|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
71817705|NCT02354963|143138263|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
71817706|NCT02354963|143138264|SUPERIORITY|||||||0.236|||||||Chi-squared|||||||0.236
71817707|NCT02354963|143138265|SUPERIORITY||Risk Ratio (RR)|0.71||||0.684|TWO_SIDED|95.0|0.13|3.68|||Chi-squared|||||3.68|0.13|0.684
71817708|NCT02354963|143138266|SUPERIORITY||Risk Ratio (RR)|0.36||||0.512|TWO_SIDED|95.0|0.04|3.05|||Chi-squared|||||3.05|0.04|0.512
71817709|NCT03125941|143138267|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.49|2.05|||Chi-squared|||||2.05|0.49|1
71817710|NCT03125941|143138268|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
71817711|NCT03125941|143138269|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
71817712|NCT03125941|143138272|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
71817713|NCT03125941|143138273|SUPERIORITY|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
71817714|NCT03125941|143138275|SUPERIORITY||||||>|0.193||||||a priori threshold, bonferroni corrected 0.0125|Wilcoxon (Mann-Whitney)|||||||>0.193
71817715|NCT03125941|143138276|SUPERIORITY||||||>|0.2|||||||Wilcoxon (Mann-Whitney)|||||||>0.2
71817716|NCT03125941|143138277|SUPERIORITY||||||>|0.136|||||||Chi-squared|||||||>0.136
71817717|NCT03125941|143138278|SUPERIORITY||||||>|0.003||||||A priori threshold for statistical significans was 0.00125 due to multiple comparisons|Chi-squared|||||||>0.003
71817718|NCT03125941|143138279|SUPERIORITY||Odds Ratio (OR)|3.53||||0.03|TWO_SIDED|95.0|1.07|11.6|||Chi-squared|||||11.6|1.07|0.030
71817719|NCT01370005|143138339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.72|-0.52||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.52|-0.72|<0.0001
71849501|NCT01163214|143212609|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 morning.||||<0.001
71849502|NCT01163214|143212609|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 afternoon.||||<0.001
71679451|NCT02045862|142876876|SUPERIORITY||Odds Ratio (OR)|1.7|||<|0.001|TWO_SIDED|95.0|1.28|2.26|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||2.26|1.28|<0.001
71679452|NCT02045862|142876876|SUPERIORITY||Odds Ratio (OR)|1.4||||0.019|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.||1.86|1.06|0.019
71679453|NCT02045862|142876877|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.46|1.40|<0.001
71679454|NCT02045862|142876877|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.19|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.||2.09|1.19|0.001
71679455|NCT02045862|142876878|SUPERIORITY||Odds Ratio (OR)|1.76|||<|0.001|TWO_SIDED|95.0|1.33|2.34|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||2.34|1.33|<0.001
71679456|NCT02045862|142876878|SUPERIORITY||Odds Ratio (OR)|1.43||||0.012|TWO_SIDED|95.0|1.08|1.89|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.||1.89|1.08|0.012
71679457|NCT02729038|142876890|OTHER||Ratio of geometric LS means|1.507|||||TWO_SIDED|90.0|0.902|2.519|||||AUC (0-inf) for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.519|0.902|
71679458|NCT02729038|142876890|OTHER||Ratio of geometric LS means|1.924|||||TWO_SIDED|90.0|1.151|3.215|||||AUC (0-inf) for participants with normal renal function Vs participants with Severe/ESRD not on hemodialysis|||3.215|1.151|
71679459|NCT02729038|142876891|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.421|3.969|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||3.969|1.421|
71679460|NCT02729038|142876891|OTHER||Ratio of geometric LS means|4.075|||||TWO_SIDED|90.0|2.438|6.81|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||6.810|2.438|
71900113|NCT02650284|143322442|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.8||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 12-months between both groups.||||0.80
71900114|NCT02650284|143322442|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.9||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare FJS at 24-months between both groups.||||0.90
71679461|NCT02729038|142876892|OTHER||Ratio of geometric LS means|1.179|||||TWO_SIDED|90.0|0.467|2.977|||||Cmax for participants with normal renal function Vs participants with moderate renal function has been presented.|||2.977|0.467|
71849503|NCT01163214|143212609|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 morning.||||0.002
71679462|NCT02729038|142876892|OTHER||Ratio of geometric LS means|1.575|||||TWO_SIDED|90.0|0.624|3.975|||||Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis|||3.975|0.624|
71679463|NCT02729038|142876893|OTHER||Ratio of geometric LS means|2.25|||||TWO_SIDED|90.0|0.891|5.681|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)|||5.681|0.891|
71679464|NCT02729038|142876893|OTHER||Ratio of geometric LS means|5.966|||||TWO_SIDED|90.0|2.363|15.062|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)|||15.062|2.363|
71679465|NCT02729038|142876915|OTHER||Ratio of geometric LS means|1.501|||||TWO_SIDED|90.0|0.894|2.52|||||Normal Vs Moderate|||2.520|0.894|
71679466|NCT02729038|142876915|OTHER||Ratio of geometric LS means|1.912|||||TWO_SIDED|90.0|1.139|3.212|||||Normal Vs Severe/ESRD not on hemodialysis|||3.212|1.139|
71679467|NCT02729038|142876916|OTHER||Ratio of geometric LS means|2.375|||||TWO_SIDED|90.0|1.414|3.989|||||Normal Vs ESRD on hemodialysis (before hemodialysis)|||3.989|1.414|
71679468|NCT02729038|142876916|OTHER||Ratio of geometric LS means|4.068|||||TWO_SIDED|90.0|2.422|6.831|||||Normal Vs ESRD on hemodialysis (after hemodialysis)|||6.831|2.422|
71849504|NCT01163214|143212609|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 afternoon.||||0.97
71849505|NCT01163214|143212610|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||Comparison between the arms for length of stay in the hospital.||||0.02
71849506|NCT01163214|143212611|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral nerve.||||0.49
71849507|NCT01163214|143212611|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for common peroneal nerve.||||0.01
71849508|NCT01163214|143212611|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for tibial nerve.||||0.62
71849509|NCT01163214|143212611|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for femoral, peroneal, or tibial nerves.||||0.009
71849510|NCT01102426|143212612|SUPERIORITY||Hazard Ratio (HR)|0.65|||=|0.0054|TWO_SIDED|95.0|0.447|0.885||Cox regression: HR p=0.0062|Log Rank|||||0.885|0.447|=0.0054
71849511|NCT01102426|143212613|SUPERIORITY|||||||0.0618|||||||Normal approximation|||||||0.0618
71900115|NCT02650284|143322444|EQUIVALENCE|Equivalence defined as less than or equal to 1 standard deviation between the two means.||||||0.81||||||The number of recruited patients did not reach the required sample size. Power score assessments no longer hold, thus there is low confidence in the findings.|t-test, 2 sided|||To compare length of hospital stay (number of nights) between both groups.||||0.81
71900116|NCT00554294|143322450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|||<|0.05||95.0|0.48|0.98|||Regression, Logistic|The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).||adjusted for overweight at baseline, age at baseline,sex and clustering by school||0.98|0.48|<0.05
71900117|NCT00337467|143322524|SUPERIORITY_OR_OTHER||Percentage of Participants|21.3|||||TWO_SIDED|95.0|11.9|33.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||33.7|11.9|
71900118|NCT00337467|143322525|SUPERIORITY_OR_OTHER||Percentage of Participants|34.4|||||TWO_SIDED|95.0|22.7|47.7|||exact binomial methods|Given the small sample size, the 95% confidence interval is made with exact binomial methods.||||47.7|22.7|
71900119|NCT00337467|143322530|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|61.0|STANDARD_ERROR_OF_MEAN|24.3|||TWO_SIDED|95.0|12.3|109.8|||normal approximation for 95% CI|||||109.8|12.3|
71900120|NCT00337467|143322531|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|30.0|||TWO_SIDED|95.0|-7.1|113.7|||normal approximation for 95% CI|||||113.7|-7.1|
71900121|NCT00337467|143322532|SUPERIORITY_OR_OTHER||Mean Change (Final Values)|63.0|STANDARD_ERROR_OF_MEAN|32.9|||TWO_SIDED|95.0|-4.0|129.1|||normal approximation for 95% CI|||||129.1|-4.0|
71900122|NCT00337467|143322534|SUPERIORITY_OR_OTHER||Mean Change|9.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|2.5|14.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 48||14.6|2.5|
71900123|NCT00337467|143322534|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-3.9|8.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 48||8.8|-3.9|
71900124|NCT00337467|143322534|SUPERIORITY_OR_OTHER||Mean Change|12.0|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|4.0|20.8|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48||20.8|4.0|
71900125|NCT00337467|143322534|SUPERIORITY_OR_OTHER||Mean Change|20.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|8.0|31.7|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 48||31.7|8.0|
71900126|NCT00337467|143322534|SUPERIORITY_OR_OTHER||Mean Change|17.0|STANDARD_ERROR_OF_MEAN|8.6|||TWO_SIDED|95.0|-0.4|34.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 48||34.4|-0.4|
71900127|NCT00337467|143322535|SUPERIORITY_OR_OTHER||Mean Change|14.0|STANDARD_ERROR_OF_MEAN|3.2||||95.0|6.9|20.1|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Total Cholesterol at Week 96||20.1|6.9|
71900128|NCT00337467|143322535|SUPERIORITY_OR_OTHER||Mean Change|2.0|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-6.0|10.2|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting HDL Cholesterol at Week 96||10.2|-6.0|
71900129|NCT00337467|143322535|SUPERIORITY_OR_OTHER||Mean Change|19.0|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|10.3|28.4|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96||28.4|10.3|
71900130|NCT00337467|143322535|SUPERIORITY_OR_OTHER||Mean Change|29.0|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|15.3|42.0|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting LDL Cholesterol at Week 96||42.0|15.3|
71900131|NCT00337467|143322535|SUPERIORITY_OR_OTHER||Mean Change|16.0|STANDARD_ERROR_OF_MEAN|12.5|||TWO_SIDED|95.0|-9.5|41.6|||normal approximation for 95% CI|||Percent Change from Baseline in Fasting Triglycerides at Week 96||41.6|-9.5|
71900132|NCT04083222|143322538|SUPERIORITY||||||<|0.001||||||P-value was analyzed using Analysis of Variance (ANOVA) with treatment and screening angiotensin-converting enzyme inhibitor/ angiotensin receptor blockers (ACEi/ARB) dose status stratification factor.|ANOVA|||||||< 0.001
71900133|NCT04083222|143322539|SUPERIORITY|||||||0.399||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.399
71849512|NCT01102426|143212614|SUPERIORITY||Hazard Ratio (HR)|0.512|||<|0.0001|TWO_SIDED|95.0|0.382|0.686||Cox regression HR: p\<0.0001|Log Rank|||||0.686|0.382|< 0.0001
71849513|NCT01102426|143212615|SUPERIORITY|||||||0.0002|||||||Normal approximation|||||||0.0002
71849514|NCT01102426|143212616|SUPERIORITY||Hazard Ratio (HR)|0.797|||=|0.1261|TWO_SIDED|95.0|0.596|1.067||Cox regression HR: p=0.1273|Log Rank|||Pre-specified||1.067|0.596|=0.1261
71849515|NCT01102426|143212617|SUPERIORITY|||||||0.3625|||||||Normal approximation|||||||0.3625
71849516|NCT01102426|143212618|SUPERIORITY|||||||0.1037|||||||Normal approximation|||||||0.1037
71849517|NCT01102426|143212619|SUPERIORITY||Hazard Ratio (HR)|0.384|||=|0.1015|TWO_SIDED|95.0|0.113|1.303||Cox regression HR: 0.1247|Log Rank|||||1.303|0.113|=0.1015
71849518|NCT01102426|143212621|SUPERIORITY||Hazard Ratio (HR)|0.043|||=|0.0001|TWO_SIDED|95.0|0.004|0.479||Cox regression HR: 0.0105|Log Rank|||Pre-specified||0.479|0.004|=0.0001
71849519|NCT01102426|143212624|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71900134|NCT04083222|143322539|SUPERIORITY|||||||0.338||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||0.338
71900135|NCT04083222|143322539|SUPERIORITY|||||||0.207||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||0.207
71900136|NCT04083222|143322539|SUPERIORITY|||||||0.927||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||0.927
71900137|NCT04083222|143322539|SUPERIORITY|||||||0.146||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||0.146
71900138|NCT04083222|143322539|SUPERIORITY|||||||0.055||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||0.055
71900139|NCT04083222|143322539|SUPERIORITY|||||||0.095||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||0.095
71900140|NCT04083222|143322539|SUPERIORITY|||||||0.046||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||0.046
71900141|NCT04083222|143322539|SUPERIORITY|||||||0.246||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||0.246
71900142|NCT04083222|143322539|SUPERIORITY|||||||0.17||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||0.170
71849520|NCT01102426|143212625|SUPERIORITY|||||||0.0085|||||||Fisher Exact|||||||0.0085
71849521|NCT01102426|143212627|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71849522|NCT01102426|143212628|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
71849523|NCT01393964|143212638|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.096||||0.704|TWO_SIDED|90.0|86.983|124.576|||ANOVA|||The reference arm is NRF participants.||124.576|86.983|0.704
71849524|NCT01393964|143212638|SUPERIORITY_OR_OTHER||ratio of adjusted means|100.454||||0.965|TWO_SIDED|90.0|84.453|119.488|||ANOVA|||The reference arm is NRF participants.||119.488|84.453|0.965
71849525|NCT01393964|143212639|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|126.596||||0.164|TWO_SIDED|90.0|95.52|167.783|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||167.783|95.52|0.164
71849526|NCT01393964|143212639|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|116.123||||0.355|TWO_SIDED|90.0|88.458|152.439|||ANOVA|||AUC(0-T). The reference arm is NRF participants.||152.439|88.458|0.355
71849527|NCT01393964|143212639|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|129.858||||0.228|TWO_SIDED|90.0|90.366|186.609|||ANOVA|||AUC (INF). The reference arm is NRF participants.||186.609|90.366|0.228
71900143|NCT04083222|143322539|SUPERIORITY|||||||0.527||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||0.527
71900144|NCT04083222|143322539|SUPERIORITY|||||||0.167||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||0.167
71900145|NCT04083222|143322539|SUPERIORITY|||||||0.266||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.266
71900146|NCT04083222|143322539|SUPERIORITY|||||||0.078||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.078
71900147|NCT04083222|143322540|SUPERIORITY|||||||0.661||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.661
71900148|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
71900149|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
71900150|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
71900151|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
71849528|NCT01393964|143212639|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|110.4||||0.642|TWO_SIDED|90.0|76.825|158.647|||ANOVA|||AUC(INF). The reference arm is NRF participants.||158.647|76.825|0.642
71849529|NCT04405180|143212649|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|4.0||0.9017|TWO_SIDED|||||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data|ANCOVA|||||||0.9017
71900152|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
71900153|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
71900154|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
71900155|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 57||||<0.001
71900156|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
71900157|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
71900158|NCT04083222|143322540|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
71900159|NCT04083222|143322540|SUPERIORITY|||||||0.106||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.106
71900160|NCT04083222|143322540|SUPERIORITY|||||||0.318||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.318
71900161|NCT04083222|143322541|SUPERIORITY|||||||0.609||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 3||||0.609
71900162|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 8||||<0.001
71900163|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 15||||<0.001
71900164|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 22||||<0.001
71900165|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 29||||<0.001
71900166|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 36||||<0.001
71900167|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 43||||<0.001
71900168|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 50||||<0.001
71900169|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 64||||<0.001
71900170|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 78||||<0.001
71900171|NCT04083222|143322541|SUPERIORITY||||||<|0.001||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 92||||<0.001
71900172|NCT04083222|143322541|SUPERIORITY|||||||0.112||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 120||||0.112
71900173|NCT04083222|143322541|SUPERIORITY|||||||0.371||||||P-value was analyzed using ANOVA with treatment and screening ACE/ARB dose status stratification factor.|ANOVA|||Day 141||||0.371
71900174|NCT03103750|143322543|SUPERIORITY|||||||0.016|||||||Mixed Models Analysis|||The primary hypothesis of calcitriol-related differences in amphetamine-induced dopamine release was determined by significance of the main effect of medication (calcitriol vs. placebo) on %change in BPND (i.e., post-Amp relative to pre-Amp scans) at a threshold of p\<0.05.||||0.016
71900175|NCT03103750|143322545|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71900176|NCT01128972|143322546|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|7.09|16.24||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||16.24|7.09|<0.0001
71900177|NCT01128972|143322546|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|26.6|||<|0.0001|TWO_SIDED|95.0|22.02|31.18||No adjustments made for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||31.18|22.02|<0.0001
71900178|NCT01128972|143322546|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.17|||<|0.0001|TWO_SIDED|95.0|32.59|41.74||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||41.74|32.59|<0.0001
71900179|NCT01128972|143322547|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.11||||0.0083|TWO_SIDED|95.0|1.07|7.15||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||7.15|1.07|0.0083
71900180|NCT01128972|143322547|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|11.25|||<|0.0001|TWO_SIDED|95.0|8.22|14.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.29|8.22|<0.0001
71900181|NCT01128972|143322547|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.56|||<|0.0001|TWO_SIDED|95.0|8.53|14.6||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||14.60|8.53|<0.0001
71900182|NCT01128972|143322548|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.88||||0.7041|TWO_SIDED|95.0|-5.46|3.69||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||3.69|-5.46|0.7041
71900183|NCT01128972|143322548|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.78|||<|0.0001|TWO_SIDED|95.0|6.21|15.36||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||15.36|6.21|<0.0001
71900184|NCT01128972|143322548|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|25.72|||<|0.0001|TWO_SIDED|95.0|21.14|30.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||30.29|21.14|<0.0001
71900185|NCT01128972|143322548|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|36.29|||<|0.0001|TWO_SIDED|95.0|31.71|40.86||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||40.86|31.71|<0.0001
71900186|NCT01128972|143322549|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.39||||0.0049|TWO_SIDED|95.0|-7.43|-1.35||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||-1.35|-7.43|0.0049
71817720|NCT01370005|143138339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.75|-0.55||Hierarchical testing, no adjustment of p-values|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.55|-0.75|<0.0001
71849530|NCT04405180|143212650|SUPERIORITY||Mean Difference (Net)|0.0342|STANDARD_ERROR_OF_MEAN|0.0417||0.4215|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.4215
71849531|NCT04405180|143212651|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|53.0||0.9024|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||.9024
71849532|NCT04405180|143212652|SUPERIORITY||Mean Difference (Net)|-59.0|STANDARD_ERROR_OF_MEAN|42.0||0.1646|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.1646
71849533|NCT04405180|143212653|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.2||0.9814|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.9814
71817721|NCT01370005|143138340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.69|<|0.0001|TWO_SIDED|95.0|-4.78|-2.09||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.09|-4.78|<0.0001
71817722|NCT01370005|143138340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.16|STANDARD_ERROR_OF_MEAN|0.68|<|0.0001|TWO_SIDED|95.0|-5.5|-2.83||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-2.83|-5.50|<0.0001
71817723|NCT01370005|143138341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.4||0.0008|TWO_SIDED|95.0|-2.15|-0.56||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.56|-2.15|0.0008
71817724|NCT01370005|143138341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.51|-0.93||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.||-0.93|-2.51|<0.0001
71849534|NCT04405180|143212654|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6217|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6217
71849535|NCT04405180|143212655|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.7981|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.7981
71849536|NCT04405180|143212656|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.6677|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.6677
71849537|NCT04405180|143212657|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|1.1||0.3745|TWO_SIDED||||||Mixed Models Analysis|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.3745
71849538|NCT04405180|143212658|SUPERIORITY||Mean Difference (Net)|243.0|STANDARD_ERROR_OF_MEAN|400.0||0.5496|TWO_SIDED||||||ANCOVA|||Adjusted for baseline value of outcome as a covariate using general linear (mixed) models and with multiple imputation for missing data||||0.5496
71900187|NCT01128972|143322549|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.28||||0.8571|TWO_SIDED|95.0|-3.31|2.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||2.76|-3.31|0.8571
71817725|NCT01370005|143138342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.0001|TWO_SIDED|95.0|3.51|11.18|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.18|3.51|<0.0001
71817726|NCT01370005|143138342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.7|11.75|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||11.75|3.70|<0.0001
71817727|NCT01370005|143138343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.76|STANDARD_ERROR_OF_MEAN|2.63|<|0.0001|TWO_SIDED|95.0|-28.91|-18.6|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo.|||-18.60|-28.91|<0.0001
71817728|NCT01370005|143138343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-35.32|-25.08|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo.|||-25.08|-35.32|<0.0001
71817729|NCT01370005|143138344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.49|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.85|-1.13|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.13|-1.85|<0.0001
71817730|NCT01370005|143138344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.33|-1.62|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.|||-1.62|-2.33|<0.0001
71817731|NCT01370005|143138345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|0.73|<|0.0001|TWO_SIDED|95.0|-5.37|-2.52|||ANCOVA|Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP|Difference calculated as empa 10mg minus placebo.|||-2.52|-5.37|<0.0001
71849539|NCT03879538|143212659|SUPERIORITY||Mean Difference (Net)|-0.57||||0.19|TWO_SIDED|95.0|-1.42|0.28||a priori threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of pain score assessed at one-week and one-month follow-up after end of treatment for Nitrous Oxide group equals that assessed at same time points for the Control group.||0.28|-1.42|0.19
71849540|NCT03879538|143212660|SUPERIORITY||Mean Difference (Net)|0.13||||0.36|TWO_SIDED|95.0|-0.16|0.43||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of physical health Z-score between two study groups: mean of physical health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.43|-0.16|0.36
71817732|NCT01370005|143138345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.78|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|-6.2|-3.36|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP|Difference calculated as empa 25mg minus placebo.|||-3.36|-6.20|<0.0001
71817733|NCT01370005|143138346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56|STANDARD_ERROR_OF_MEAN|0.44||0.0004|TWO_SIDED|95.0|-2.42|-0.69|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 10mg minus placebo.|||-0.69|-2.42|0.0004
71817734|NCT01370005|143138346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.84|-1.12|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 25mg minus placebo.|||-1.12|-2.84|<0.0001
71817735|NCT01370005|143138347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.81||0.0021|TWO_SIDED|95.0|-4.09|-0.91|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 10mg minus placebo.|||-0.91|-4.09|0.0021
71849541|NCT03879538|143212660|SUPERIORITY||Mean Difference (Net)|0.087||||0.66|TWO_SIDED|95.0|-0.31|0.48||a priori threshold for statistical significance is p\<0.05.|Mixed Models Analysis||Mean difference is Nitrous oxide minus control.|Null hypothesis for testing difference in means of mental health Z-score between two study groups: mean of mental health Z-score assessed at one-week and one-month follow-ups for Nitrous Oxide group was equal to that assessed at the same follow-up time points for Control group.||0.48|-0.31|0.66
71900188|NCT01128972|143322549|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.87|||<|0.0001|TWO_SIDED|95.0|3.83|9.9||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||9.90|3.83|<0.0001
71817736|NCT01370005|143138347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.81||0.0003|TWO_SIDED|95.0|-4.48|-1.32|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 25mg minus placebo.|||-1.32|-4.48|0.0003
71849542|NCT03879538|143212661|SUPERIORITY||Mean Difference (Net)|-0.7||||0.23|TWO_SIDED|95.0|-1.85|0.46||a priori threshold for statistical significance is p = 0.05.|Mixed Models Analysis||Mean difference is Nitrous Oxide minus Control.|Null hypothesis: Mean of PGIC scale assessed at one-week and one-month follow-up time points for Nitrous Oxide patients is equal to that assessed at the same time points for Control patients.||0.46|-1.85|0.23
71849543|NCT03265132|143212683|SUPERIORITY||Risk Difference (RD)|1.0||||0.0022|TWO_SIDED|95.0|0.42|1.0|||Fisher Exact|||||1.00|0.42|0.0022
71849544|NCT00687297|143212735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||1||95.0|||||Fisher Exact|||Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.||||1.00
71688682|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|90.0|0.26|0.37|||t-test, 2 sided|||FEV1 Day 8 (1 hrs post-dose)||0.37|0.26|<0.0001
71817737|NCT01370005|143138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.5||0.0566|TWO_SIDED|95.0|-1.93|0.03|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 10mg minus placebo.|||0.03|-1.93|0.0566
71817738|NCT01370005|143138348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.5||0.0208|TWO_SIDED|95.0|-2.12|-0.18|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 25mg minus placebo.|||-0.18|-2.12|0.0208
71817739|NCT01370005|143138349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.99|<|0.0001|TWO_SIDED|95.0|-5.86|-1.98|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 10mg minus placebo.|||-1.98|-5.86|<0.0001
71817740|NCT01370005|143138349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.73|-2.87|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 25mg minus placebo.|||-2.87|-6.73|<0.0001
71817741|NCT01370005|143138350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.55||0.0005|TWO_SIDED|95.0|-3.01|-0.84|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 10mg minus placebo.|||-0.84|-3.01|0.0005
71817742|NCT01370005|143138350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.55||0.0006|TWO_SIDED|95.0|-2.97|-0.82|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 25mg minus placebo.|||-0.82|-2.97|0.0006
71817743|NCT01370005|143138351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0021|TWO_SIDED|95.0|1.39|4.45|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||4.45|1.39|0.0021
71817744|NCT01370005|143138351|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0088|TWO_SIDED|95.0|1.22|3.96|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c||||3.96|1.22|0.0088
71817745|NCT01871558|143138368|SUPERIORITY_OR_OTHER|||||||0.139|||||||Chi-squared|||||||0.139
71817746|NCT02736968|143138378|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.12|0.12||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of resolution of diarrhea by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.12|-0.12|>0.999
71817747|NCT02736968|143138379|SUPERIORITY||Difference in Proportions|0.0|||>|0.999|TWO_SIDED|95.0|-0.34|0.34||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Fisher Exact||Adjusted Wald Intervals|The null hypothesis is that the probability of parasitological response by Day 5 for participants receiving auranofin is equal to that for those receiving placebo.||0.34|-0.34|>0.999
71817748|NCT02736968|143138384|SUPERIORITY|||||||0.142||||||No adjustment for multiple comparisons was made. The a priori threshold for statistical significance is 0.05.|Log Rank|||The null hypothesis is that there is no difference in time to resolution of diarrhea between treatment arms, with a two-sided alternative.||||0.142
71817749|NCT01861457|143138402|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71817750|NCT01861457|143138403|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71817751|NCT02041923|143138406|EQUIVALENCE|A t-test was conducted to evaluate equivalency.|Mean Difference (Net)|46.3|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71817752|NCT02049710|143138412|OTHER||Mean Difference (Final Values)|5.06|||||TWO_SIDED|95.0|3.0|15.0||||||Summation scores are reported across 3 items measured on a 5-point scale from 1(not at all sure)to5(very sure), which loaded together on a principal components analysis of the baseline data.The summation score thus represents a theoretical range from 3 to 15.The 3 items were as follows:Indicate How Sure You are that You Would be Able to Perform Each of the Following:a)Get the money needed to buy condoms b)Walk into a store\&buy condoms c)Find a place to get condoms for free(Cronbach alpha-0.72)||15|3|
71817753|NCT00874432|143138419|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||p-value for CBPWV between CKD and Control groups||||0.685
71817754|NCT00874432|143138419|SUPERIORITY|||||||0.739|||||||t-test, 2 sided|||p-value for CRPWV between CKD and Control groups||||0.739
71817755|NCT00874432|143138419|SUPERIORITY|||||||0.471|||||||t-test, 2 sided|||p-value for CFPWV between CKD and Control groups||||0.471
71817756|NCT00874432|143138420|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||This p-value compares the baseline CBPWV measures for the CKD vs Controls group||||0.685
71849545|NCT00687297|143212736|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49||||0.02|TWO_SIDED|95.0|1.07|2.07||p-value from Wald test|Regression, Cox|The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)||There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.||2.07|1.07|0.02
71849546|NCT00244751|143212745|SUPERIORITY_OR_OTHER|||||||0.3608|||||||reduced regression model|||||||0.3608
71817757|NCT00874432|143138420|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.869
71817758|NCT00874432|143138420|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||This p-value compares the baseline CRPWV measures for the CKD vs Controls group||||0.709
71817759|NCT00874432|143138420|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||This p-value compares the 12 month CBPWV measures for the CKD vs Controls group||||0.340
71817760|NCT00874432|143138420|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||This p-value compares the baseline CFPWV measures for the CKD vs Controls group||||0.730
71817761|NCT00874432|143138420|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||This p-value compares the 12 month CFPWV measures for the CKD vs Controls group||||0.204
71817762|NCT00874432|143138420|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of ACE-I CKD and Control groups||||0.963
71817763|NCT00874432|143138420|SUPERIORITY|||||||0.991|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of ACE-I CKD and Control groups||||0.991
71817764|NCT00874432|143138420|SUPERIORITY|||||||0.176|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of ACE-I CKD and Control groups||||0.176
71817765|NCT00874432|143138420|SUPERIORITY|||||||0.402|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I CKD||||0.402
71817766|NCT00874432|143138420|SUPERIORITY|||||||0.586|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I CKD||||0.586
71817767|NCT00874432|143138420|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I CKD||||0.455
71817768|NCT00874432|143138420|SUPERIORITY|||||||0.418|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the ACE-I Control Group||||0.418
71817769|NCT00874432|143138420|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the ACE-I Control Group||||0.091
71817770|NCT00874432|143138420|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the ACE-I Control Group||||0.034
71817771|NCT00874432|143138420|SUPERIORITY|||||||0.921|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure of the CKD and Control groups||||0.921
71817772|NCT00874432|143138420|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure of the CKD and Control groups||||0.887
71817773|NCT00874432|143138420|SUPERIORITY|||||||0.759|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure of the CKD and Control groups||||0.759
71817774|NCT00874432|143138420|SUPERIORITY|||||||0.851|||||||t-test, 2 sided|||This compares the baseline and 12 month CBPWV measure of the Control groups||||0.851
71817775|NCT00874432|143138420|SUPERIORITY|||||||0.733|||||||t-test, 2 sided|||This compares the baseline and 12 month CRPWV measure of the Control groups||||0.733
71817776|NCT00874432|143138420|SUPERIORITY|||||||0.902|||||||t-test, 2 sided|||This compares the baseline and 12 month CFPWV measure of the Control groups||||0.902
71817777|NCT00874432|143138420|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the CKD ACE-I and CKD Control groups.||||0.414
71817778|NCT00874432|143138420|SUPERIORITY|||||||0.942|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the CKD ACE-I and CKD Control groups.||||0.942
71817779|NCT00874432|143138420|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the CKD ACE-I and CKD Control groups.||||0.990
71817780|NCT00874432|143138420|SUPERIORITY|||||||0.273|||||||t-test, 2 sided|||This compares the 12 month CBPWV measure between the ACE-I Control and CKD Control groups.||||0.273
71849547|NCT00244751|143212745|SUPERIORITY_OR_OTHER|||||||0.3575|||||||reduced regression model|||||||0.3575
71849548|NCT00244751|143212746|SUPERIORITY_OR_OTHER|||||||0.9157|||||||reduced regression model|||||||0.9157
71849549|NCT00244751|143212746|SUPERIORITY_OR_OTHER|||||||0.9501|||||||reduced regression model|||||||0.9501
71817781|NCT00874432|143138420|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||This compares the 12 month CRPWV measure between the ACE-I Control and CKD Control groups.||||0.516
71817782|NCT00874432|143138420|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||This compares the 12 month CFPWV measure between the ACE-I Control and CKD Control groups.||||0.102
71817783|NCT01158378|143138456|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%||||||0.0049|||||||one-sided z-test|||||||0.0049
71817784|NCT01158378|143138457|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
71817785|NCT01158378|143138457|SUPERIORITY_OR_OTHER|||||||0.0297|||||||one-sided z-test|||Superiority Test||||0.0297
71817786|NCT01158378|143138458|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test|||||||<0.0001
71817787|NCT01158378|143138458|SUPERIORITY_OR_OTHER|||||||0.0561|||||||one-sided z-test|||Superiority Test||||0.0561
71849550|NCT00244751|143212747|SUPERIORITY_OR_OTHER|||||||0.6483|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (fibrosis)||||0.6483
71849551|NCT00244751|143212747|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (necrosis)||||0.1776
71817788|NCT03017235|143138460|NON_INFERIORITY|The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.|Difference in percentage|6.3||||0.0067|TWO_SIDED|95.0|1.8|10.9||The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)|Lower limit of 95% CI \> 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.|10.9|1.8|0.0067
71817789|NCT03017235|143138461|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|4.6||||0.0099|TWO_SIDED|95.0|1.1|8.0||The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)||8.0|1.1|0.0099
71849552|NCT02206607|143212773|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.27|||||TWO_SIDED|90.0|28.09|34.8||||||||34.80|28.09|
71849553|NCT02206607|143212773|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|25.56|||||TWO_SIDED|90.0|23.11|28.27||||||||28.27|23.11|
71849554|NCT02206607|143212773|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|32.04|||||TWO_SIDED|90.0|28.93|35.49||||||||35.49|28.93|
71849555|NCT02206607|143212774|SUPERIORITY_OR_OTHER||Least Square Mean|15.72|STANDARD_ERROR_OF_MEAN|3.357||1|TWO_SIDED|80.0|11.39|20.06||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.06|11.39|1.0000
71817790|NCT03017235|143138462|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|1.9||||0.1781|TWO_SIDED|95.0|-0.9|4.7||The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)||4.7|-0.9|0.1781
71817791|NCT03017235|143138463|NON_INFERIORITY|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.|Difference in percentage|3.5||||0.0391|TWO_SIDED|95.0|0.2|6.7||The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)||6.7|0.2|0.0391
71817792|NCT00437125|143138520|SUPERIORITY_OR_OTHER||Percentage|8.6|||||ONE_SIDED|95.0||13.3||||||||13.3||
71817793|NCT00437125|143138521|SUPERIORITY_OR_OTHER|||||||0.5553||95.0||||p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.||||0.5553
71900189|NCT01128972|143322549|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.17|||<|0.0001|TWO_SIDED|95.0|4.14|10.21||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.21|4.14|<0.0001
71817794|NCT00437125|143138522|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for psychic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.||||<0.0001
71817795|NCT00437125|143138522|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for neurological subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.||||<0.0001
71817796|NCT00437125|143138522|SUPERIORITY_OR_OTHER|||||||0.0014||95.0||||p-value is for autonomic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.||||0.0014
71817797|NCT00437125|143138522|SUPERIORITY_OR_OTHER|||||||0.5586||95.0||||p-value is for other subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.||||0.5586
71817798|NCT00437125|143138522|SUPERIORITY_OR_OTHER|||||||0.0848||95.0||||p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.||||0.0848
71817799|NCT00437125|143138522|SUPERIORITY_OR_OTHER|||||||0.0263||95.0||||p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.||||0.0263
71817800|NCT00437125|143138523|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 4 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.||||<0.0001
71817801|NCT00437125|143138523|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 8 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.||||<0.0001
71817802|NCT00437125|143138523|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for 12 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.||||<0.0001
71817803|NCT00437125|143138524|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.||||<0.0001
71817804|NCT00437125|143138525|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.||||<0.0001
71679469|NCT02822573|142876933|SUPERIORITY|Mixed effects repeated measures analysis of covariance (RMANCOVA) models with covariates of treatment, time, time by treatment interaction, baseline outcome level, age stratification and an unstructured covariance matrix. The primary objective was assessed using a linear contrast of group effect at 24 weeks.||||||0.32|||||||ANCOVA|||With a sample size of 266, there was 90% power to detect a treatment difference of 2 words for HVLT-R total recall score (SD=4.26, effect size=0.47) with a two-sided 5% level of significance. This calculation assumed an ANCOVA model analysis with 25% dropout and 2% missing data at end of treatment. A single interim analysis for futility occurred after 138 participants, with stopping rule of two-sided p-value \< 0.0154. This design required 3.5% more than fixed design, increasing total to 276.||||0.32
71817805|NCT00437125|143138527|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for BDI score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores||||<0.0001
71817806|NCT00437125|143138528|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.||||0.0027
71817807|NCT00437125|143138528|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.||||0.0002
71817808|NCT00437125|143138528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.||||<0.0001
71817809|NCT00437125|143138528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.||||<0.0001
71817810|NCT00437125|143138528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.||||<0.0001
71817811|NCT00437125|143138528|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.||||<0.0001
71817812|NCT00437125|143138529|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.||||<0.0001
71679470|NCT02275780|142876940|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|3.913|||||TWO_SIDED|95.0|-1.59|9.415|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.415|-1.590|
71817813|NCT02248961|143138538|OTHER|It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.|Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|1.0|=|0.39|ONE_SIDED|95.0||1.47|||Mixed Models Analysis|||"The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).~Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases."||1.47||=0.390
71817814|NCT02248961|143138539|OTHER||||||=|0.018|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.018
71817815|NCT02248961|143138540|OTHER||||||=|0.579|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.579
71817816|NCT02248961|143138541|OTHER||||||=|0.466|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.466
71817817|NCT02248961|143138542|OTHER||||||=|0.118|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.118
71817818|NCT02248961|143138543|OTHER||||||=|0.662|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.||||||=0.662
71817819|NCT02248961|143138544|OTHER||||||=|0.143|||||||Mantel Haenszel|||||||=0.143
71817820|NCT01288781|143138545|SUPERIORITY_OR_OTHER|||||||0.98||||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
71817821|NCT01288781|143138546|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.63
71817822|NCT01288781|143138547|SUPERIORITY_OR_OTHER|||||||0.2||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.20
71817823|NCT01288781|143138548|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||<0.01
71849556|NCT02206607|143212774|SUPERIORITY_OR_OTHER||Least Square Mean|16.31|STANDARD_ERROR_OF_MEAN|3.399||1|TWO_SIDED|80.0|11.93|20.7||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.||||20.70|11.93|1.000
71849557|NCT02206607|143212774|SUPERIORITY_OR_OTHER||Least Square Mean|20.38|STANDARD_ERROR_OF_MEAN|3.291||1|TWO_SIDED|80.0|16.13|24.62||1-sided p-value|Mixed Models Analysis|||||24.62|16.13|1.0000
71849558|NCT02206607|143212775|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|25.21|||||TWO_SIDED|90.0|23.28|27.31||||||||27.31|23.28|
71849559|NCT02206607|143212775|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|26.38|||||TWO_SIDED|90.0|24.36|28.57||||||||28.57|24.36|
71849560|NCT02206607|143212775|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|36.94|||||TWO_SIDED|90.0|34.09|40.02||||||||40.02|34.09|
71849561|NCT02206607|143212781|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR1/IR|31.06|||||TWO_SIDED|90.0|28.28|34.1||||||||34.10|28.28|
71849562|NCT02206607|143212781|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR2/IR|24.96|||||TWO_SIDED|90.0|22.73|27.4||||||||27.40|22.73|
71849563|NCT02206607|143212781|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio MR3/IR|31.69|||||TWO_SIDED|90.0|28.86|34.81||||||||34.81|28.86|
71849564|NCT01262456|143212786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||<|0.0001|TWO_SIDED|95.0|-0.61|-0.22||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.22|-0.61|<0.0001
71817824|NCT01288781|143138548|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Step down Holm Bonferroni correction was applied|t-test, 2 sided|||Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point.||||<0.01
71817825|NCT01288781|143138549|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
71817826|NCT01288781|143138550|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
71849565|NCT01262456|143212786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0003|TWO_SIDED|95.0|-0.57|-0.17||A priori threshold for significance was p\<=0.05|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.17|-0.57|0.0003
71849566|NCT01262456|143212787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.0004|TWO_SIDED|95.0|1.38|3.03||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||3.03|1.38|0.0004
71849567|NCT01262456|143212787|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.0009|TWO_SIDED|95.0|1.32|2.96||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (\<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.||2.96|1.32|0.0009
71817827|NCT01288781|143138551|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P \< 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) \* 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) \* 6 (time: sea level, 3 \& 12; high altitude, 3, 12, 24 \& 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug \* time interaction.||||0.98
71817828|NCT03518658|143138552|SUPERIORITY||Mean Difference (Final Values)|34.7|||<|0.001|TWO_SIDED|95.0|32.4|37.0||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||37.0|32.4|<0.001
71817829|NCT03518658|143138552|SUPERIORITY||Mean Difference (Final Values)|38.3|||<|0.001|TWO_SIDED|95.0|34.8|41.9||The threshold for statistical significance was 0.025.|Generalized estimating equation model|||||41.9|34.8|<0.001
71817830|NCT02444988|143138581|SUPERIORITY||Odds Ratio (OR)|0.87|||<|0.05|TWO_SIDED|95.0|0.77|0.99|||Regression, Logistic|||||0.99|0.77|<0.05
71817831|NCT02444988|143138582|SUPERIORITY||Odds Ratio (OR)|0.84|||<|0.05|TWO_SIDED|95.0|0.73|0.97|||Regression, Logistic|||||0.97|0.73|<0.05
71817832|NCT02105636|143138596|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.0101|TWO_SIDED|95.0|0.53|0.92||Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.|Log Rank||Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.|Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)||0.92|0.53|0.0101
71817833|NCT02105636|143138597|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.1|||||Number of responders (CR +PR) over number of participants|||1.10|0.68|
71817834|NCT02105636|143138598|SUPERIORITY||Difference in ORR|7.6|||||TWO_SIDED|95.0|1.5|13.6|||||Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.|||13.6|1.5|
71817835|NCT02105636|143138598|SUPERIORITY||CMH Estimate of Common Odds Ratio|2.49|||||TWO_SIDED|95.0|1.07|5.82|||||Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.|||5.82|1.07|
71817836|NCT02105636|143138599|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.54|0.85|||||Stratified Cox proportional hazards model. Hazard ratio of nivolumab to investigator's choice therapy.|||0.85|0.54|
71817837|NCT00871351|143138600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-5.8|||Hochberg's method|||||-5.8|-15.4|<0.0001
71817838|NCT00871351|143138600|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-26.5|||<|0.0001|TWO_SIDED|95.0|-31.8|-21.2|||Hochberg's method|||||-21.2|-31.8|<0.0001
71817839|NCT00871351|143138601|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Hochberg's method|||||||0.0003
71817840|NCT00871351|143138601|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Hochberg's method|||||||<0.0001
71817841|NCT02791490|143138607|SUPERIORITY||Difference in Least Squares Means|-0.41|||<|0.001|TWO_SIDED|95.0|-0.59|-0.23|||Longitudinal Data Analysis|||||-0.23|-0.59|<0.001
71817842|NCT02791490|143138608|OTHER|95% CI|Difference in % vs Placebo|-1.7|||||TWO_SIDED|95.0|-10.8|7.4|||Miettinen and Nurminen method|||||7.4|-10.8|
71817843|NCT02791490|143138610|SUPERIORITY||Relative Risk|1.7||||0.002|TWO_SIDED|95.0|1.2|2.5|||Miettinen and Nurminen method|||||2.5|1.2|0.002
71817844|NCT02791490|143138611|SUPERIORITY||Difference in Least Squares Means|-12.4||||0.002|TWO_SIDED|95.0|-20.2|-4.6|||Longitudinal Data Analysis|||||-4.6|-20.2|0.002
71817845|NCT01984424|143138614|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.29|<|0.0001|TWO_SIDED|95.0|-42.31|-33.28|||Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.28|-42.31|<0.0001
71817846|NCT01984424|143138615|SUPERIORITY||LS Mean Treatment Difference|-36.07|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|95.0|-41.07|-31.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-31.08|-41.07|<0.0001
71817847|NCT01984424|143138616|SUPERIORITY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001|TWO_SIDED|95.0|-84.7|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-67.0|-84.7|<0.0001
71817848|NCT01984424|143138617|SUPERIORITY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001|TWO_SIDED|95.0|-81.3|-62.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-62.2|-81.3|<0.0001
71817849|NCT01984424|143138618|SUPERIORITY||Treatment Difference|28.5|||<|0.0001|TWO_SIDED|95.0|19.1|36.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.7|19.1|<0.0001
71817850|NCT01984424|143138619|SUPERIORITY||Treatment Difference|27.4|||<|0.0001|TWO_SIDED|95.0|17.7|36.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).||||36.1|17.7|<0.0001
71817851|NCT01984424|143138620|SUPERIORITY||LS Mean Treatment Difference|-26.61|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-29.95|-23.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-23.27|-29.95|<0.0001
71849568|NCT01262456|143212788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0029|TWO_SIDED|95.0|-0.57|-0.12||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.12|-0.57|0.0029
71849569|NCT01262456|143212788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0128|TWO_SIDED|95.0|-0.52|-0.06||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."||-0.06|-0.52|0.0128
71849570|NCT01262456|143212789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0233|TWO_SIDED|95.0|1.08|3.02||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||3.02|1.08|0.0233
71849571|NCT01262456|143212789|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0386|TWO_SIDED|95.0|1.03|2.87||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||2.87|1.03|0.0386
71849572|NCT01262456|143212790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42.76||||0.0026|TWO_SIDED|95.0|15.02|70.51||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||70.51|15.02|0.0026
71849573|NCT01262456|143212790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.95||||0.0064|TWO_SIDED|95.0|11.03|66.88||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||66.88|11.03|0.0064
71849574|NCT01262456|143212791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-86.17||||0.0034|TWO_SIDED|95.0|-143.69|-28.64||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-28.64|-143.69|0.0034
71849575|NCT01262456|143212791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-77.8||||0.0086|TWO_SIDED|95.0|-135.7|-19.89||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||-19.89|-135.70|0.0086
71849576|NCT01262456|143212792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.31||||0.4126|TWO_SIDED|95.0|-153.94|63.32||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||63.32|-153.94|0.4126
71849577|NCT01262456|143212792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.79||||0.7353|TWO_SIDED|95.0|-127.99|90.41||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).||90.41|-127.99|0.7353
71849578|NCT02516202|143212802|SUPERIORITY|||||||0.25||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.25
71849579|NCT02516202|143212802|SUPERIORITY|||||||0.31||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.31
71849580|NCT02516202|143212803|SUPERIORITY|||||||0.99||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.99
71849581|NCT02516202|143212803|SUPERIORITY|||||||0.05||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.05
71817852|NCT01984424|143138621|SUPERIORITY||LS Mean Treatment Difference|-25.08|STANDARD_ERROR_OF_MEAN|1.82|<|0.0001|TWO_SIDED|95.0|-28.67|-21.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-21.48|-28.67|<0.0001
71817853|NCT01984424|143138622|SUPERIORITY||LS Mean Treatment Difference|-33.06|STANDARD_ERROR_OF_MEAN|2.06|<|0.0001|TWO_SIDED|95.0|-37.12|-28.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-28.99|-37.12|<0.0001
71817854|NCT01984424|143138623|SUPERIORITY||LS Mean Treatment Difference|-31.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.0001|TWO_SIDED|95.0|-35.44|-16.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-16.76|-35.44|<0.0001
71817855|NCT01984424|143138624|SUPERIORITY||LS Mean Treatment Difference|-33.86|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-38.15|-29.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.58|-38.15|<0.0001
71817856|NCT01984424|143138625|SUPERIORITY||LS Mean Treatment Difference|-31.75|STANDARD_ERROR_OF_MEAN|2.33|<|0.0001|TWO_SIDED|95.0|-36.35|-27.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.16|-36.35|<0.0001
71817857|NCT01984424|143138626|SUPERIORITY||LS Mean Treatment Difference|-29.91|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-34.06|-25.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-25.77|-34.06|<0.0001
71817858|NCT01984424|143138627|SUPERIORITY||LS Mean Treatment Difference|-27.2|STANDARD_ERROR_OF_MEAN|2.22|<|0.0001|TWO_SIDED|95.0|-31.58|-22.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-22.82|-31.58|<0.0001
71817859|NCT01984424|143138628|SUPERIORITY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.0001|TWO_SIDED|95.0|-38.59|-29.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-29.67|-38.59|<0.0001
71817860|NCT01984424|143138629|SUPERIORITY||LS Mean Treatment Difference|-31.98|STANDARD_ERROR_OF_MEAN|2.36|<|0.0001|TWO_SIDED|95.0|-36.64|-27.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-27.32|-36.64|<0.0001
71817861|NCT01984424|143138630|SUPERIORITY||LS Mean Treatment Difference|-21.08|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-27.65|-14.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.51|-27.65|<0.0001
71849582|NCT02516202|143212804|SUPERIORITY|||||||0.64||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.64
71817862|NCT01984424|143138631|SUPERIORITY||LS Mean Treatment Difference|-21.24|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|TWO_SIDED|95.0|-28.42|-14.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||-14.05|-28.42|<0.0001
71817863|NCT01984424|143138632|SUPERIORITY||LS Mean Treatment Difference|-4.44|STANDARD_ERROR_OF_MEAN|4.72||0.37|TWO_SIDED|95.0|-13.74|4.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||4.87|-13.74|0.37
71817864|NCT01984424|143138633|SUPERIORITY||LS Mean Treatment Difference|-1.82|STANDARD_ERROR_OF_MEAN|6.0||0.37|TWO_SIDED|95.0|-13.64|10.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.01|-13.64|0.37
71679471|NCT02275780|142876941|NON_INFERIORITY|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|7.082|||||TWO_SIDED|95.0|0.508|13.656|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||13.656|0.508|
71679472|NCT02275780|142876942|OTHER||Mean treatment difference|7.1|||||TWO_SIDED|95.0|-20.8|35.0|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||35.0|-20.8|
71679473|NCT02275780|142876943|OTHER||Mean treatment difference|17.4|||||TWO_SIDED|95.0|-14.5|49.3|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||49.3|-14.5|
71679474|NCT02275780|142876944|OTHER||Treatment Difference (mg/dL)|-14.61|||<|0.0001|TWO_SIDED|95.0|-18.15|-11.06|||ANCOVA|Terms for Baseline lipid level and treatment group||||-11.06|-18.15|<0.0001
71679475|NCT02275780|142876945|OTHER||Treatment Difference (mg/dL)|-19.34|||<|0.0001|TWO_SIDED|95.0|-23.33|-15.35|||ANCOVA|Terms for Baseline lipid level and treatment group||||-15.35|-23.33|<0.0001
71849583|NCT02516202|143212804|SUPERIORITY|||||||0.17||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||||||0.17
71849584|NCT02516202|143212806|SUPERIORITY|||||||0.02||||||p-value calculation includes 195 participants with known responses at week 12.|Chi-squared|||||||0.02
71849585|NCT02516202|143212807|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71849586|NCT02516202|143212807|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
71849587|NCT02516202|143212808|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71679476|NCT02275780|142876954|OTHER||Treatment Difference|4.169|||||TWO_SIDED|95.0|-1.404|9.743|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||9.743|-1.404|
71900190|NCT01128972|143322550|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.94|||||TWO_SIDED|95.0|10.36|19.51||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.||19.51|10.36|
71679477|NCT02275780|142876955|OTHER||Treatment Difference|7.606|||||TWO_SIDED|95.0|0.98|14.232|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.|||14.232|0.980|
71679478|NCT03960866|142876956|SUPERIORITY||Mean Difference (Net)|0.12||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
71679479|NCT00308087|142876968|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||"Exact Conditional Test is stratified on the number~\> of prior therapies (1 or 2, 3 or more prior therapies)."|2-sided Exact Conditional Test|||||||0.6182
71679480|NCT00308087|142876971|SUPERIORITY_OR_OTHER|||||||0.5501||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.5501
71679481|NCT00308087|142876972|SUPERIORITY_OR_OTHER|||||||0.8217||95.0|||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.||||0.8217
71849588|NCT02516202|143212808|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71849589|NCT00337610|143212809|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02|STANDARD_DEVIATION|1.19|<|0.001||95.0|-1.36|-0.67|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic agent (AHA) \[medication\] (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.67|-1.36|<0.001
71849590|NCT00337610|143212810|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-25.5|STANDARD_DEVIATION|42.2|<|0.001||95.0|-37.7|-13.3|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-13.3|-37.7|<0.001
71849591|NCT00337610|143212811|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-54.1|STANDARD_DEVIATION|63.8|<|0.001||95.0|-74.7|-33.6|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-33.6|-74.7|<0.001
71849592|NCT00337610|143212812|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.01|STANDARD_DEVIATION|1.34|<|0.001||95.0|-1.4|-0.62|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)||||-0.62|-1.40|<0.001
71849593|NCT04012970|143212813|SUPERIORITY||||||<|0.05|||||||ANOVA|2-way, repeated measures||||||<0.05
71849594|NCT04012970|143212813|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
71849595|NCT04012970|143212814|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
71849596|NCT04012970|143212814|SUPERIORITY||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.01
71849597|NCT04012970|143212815|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
71849598|NCT04012970|143212815|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
71849599|NCT04012970|143212816|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
71849600|NCT04012970|143212816|SUPERIORITY||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).||||<0.05
71849601|NCT04012970|143212817|SUPERIORITY||||||<|0.01|||||||ANOVA|2-way, repeated measures||||||<0.01
71849602|NCT04012970|143212818|SUPERIORITY||||||<|0.001|||||||ANOVA|2-way, repeated measures||||||<0.001
71849603|NCT03205488|143212819|SUPERIORITY|||||||0.3626|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 150 group to the Placebo group.||||||0.3626
71900191|NCT01128972|143322551|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.14|||<|0.0001|TWO_SIDED|95.0|4.11|10.18||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||10.18|4.11|<0.0001
71900192|NCT02429427|143322554|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.751|TWO_SIDED|95.0|0.8|1.17|||Log Rank|Analysis stratified by oestrogen receptor status and country.|Analysis stratified by oestrogen receptor status and country.|||1.17|0.80|0.751
71900193|NCT02429427|143322555|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.781|TWO_SIDED|95.0|0.76|1.22|||Log Rank|Analysis is stratified for oestrogen receptor status and country.|Analysis is stratified for oestrogen receptor status and country.|||1.22|0.76|0.781
71900194|NCT00747617|143322558|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Mixed Models Analysis|||||||<0.05
71817865|NCT01984424|143138634|SUPERIORITY||LS Mean Treatment Difference|6.18|STANDARD_ERROR_OF_MEAN|2.05||0.0083|TWO_SIDED|95.0|2.15|10.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||10.22|2.15|0.0083
71817866|NCT01984424|143138635|SUPERIORITY||LS Mean Treatment Difference|4.5|STANDARD_ERROR_OF_MEAN|2.27||0.0083|TWO_SIDED|95.0|0.02|8.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||8.98|0.02|0.0083
71817867|NCT01984424|143138636|SUPERIORITY||LS Mean Treatment Difference|-4.65|STANDARD_ERROR_OF_MEAN|3.85||0.37|TWO_SIDED|95.0|-12.25|2.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||2.94|-12.25|0.37
71817868|NCT01984424|143138637|SUPERIORITY||LS Mean Treatment Difference|-1.23|STANDARD_ERROR_OF_MEAN|4.67||0.37|TWO_SIDED|95.0|-10.45|7.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||||7.98|-10.45|0.37
71817869|NCT00077636|143138640|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.46|0.76|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.76|0.46|<.0001
71900195|NCT02279524|143322568|SUPERIORITY||Difference in least square means|-3.09||||0.0655|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0655
71900196|NCT02279524|143322568|SUPERIORITY||Difference in least square means|-3.32||||0.045|TWO_SIDED|1.6|||||Mixed Models Analysis||||Post-Hoc Responder Analysis - was also carried out. See Post-Hoc analysis|||0.0450
71900197|NCT02279524|143322569|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0514|TWO_SIDED|95.0|0.99|22.66|||Regression, Logistic|The method used was a Baseline Adjusted Logistic Regression||||22.66|0.99|0.0514
71900198|NCT02279524|143322569|SUPERIORITY||Odds Ratio (OR)|1.79||||0.4955|TWO_SIDED|95.0|0.33|9.61|||Regression, Logistic|||||9.61|0.33|0.4955
71900199|NCT02279524|143322570|SUPERIORITY||Odds Ratio (OR)|1.88||||0.211|TWO_SIDED|95.0|0.7|5.04|||Regression, Logistic|||||5.04|0.70|0.2110
71900200|NCT02279524|143322570|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8425|TWO_SIDED|95.0|0.4|3.05|||Regression, Logistic|||||3.05|0.40|0.8425
71900201|NCT02279524|143322571|SUPERIORITY||Difference in least square means|-29.1|STANDARD_ERROR_OF_MEAN|6.4|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.0001
71817870|NCT00077636|143138641|NON_INFERIORITY_OR_EQUIVALENCE|In the analysis based on the standard population, end of treatment virological response was equivalent in the two treatment arms (94% in the 16-week arm and 92% in the 24-week arm).|Odds Ratio (OR)|1.32||||0.1941|TWO_SIDED|95.0|0.86|2.03|||Cochran-Mantel-Haenszel|stratified by country.||||2.03|0.86|0.1941
71900202|NCT02279524|143322571|SUPERIORITY||Difference in least square means|-23.8|STANDARD_ERROR_OF_MEAN|6.3||0.0002|TWO_SIDED||||||Mixed Models Analysis|||||||0.0002
71900203|NCT02279524|143322572|SUPERIORITY||Difference in least square means|-0.447||||0.0008|TWO_SIDED|95.0|-0.7063|-0.1877|||Mixed Models Analysis|||||-0.1877|-0.7063|0.0008
71817871|NCT00077636|143138642|NON_INFERIORITY_OR_EQUIVALENCE|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.65||||0.0003|TWO_SIDED|95.0|0.52|0.82|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.||||0.82|0.52|0.0003
71817872|NCT01993017|143138664|SUPERIORITY|||||||0.98||||||A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value \<.05.|ANOVA|||We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.||||0.98
71900204|NCT02279524|143322572|SUPERIORITY||Difference in least square means|-0.362||||0.0061|TWO_SIDED|95.0|-0.6196|-0.1043|||Mixed Models Analysis|||||-0.1043|-0.6196|0.0061
71900205|NCT02279524|143322573|SUPERIORITY||Difference in least square means|-17.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71817873|NCT00917267|143138668|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is \<0; noninferiority concluded if upper limit is \<0.4%.|Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||Mixed Models Analysis|||MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.||-0.14|-0.49|<.001
71817874|NCT00917267|143138669|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.||||0.003
71817875|NCT00917267|143138670|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target \<=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.||||<.001
71817876|NCT00917267|143138671|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.67|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-22.5|-10.83|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||-10.83|-22.50|<.001
71900206|NCT02279524|143322573|SUPERIORITY||Difference in least square means|-13.9|STANDARD_ERROR_OF_MEAN|4.2||0.0011|TWO_SIDED||||||Mixed Models Analysis|||||||0.0011
71900207|NCT02279524|143322574|SUPERIORITY||Odds Ratio (OR)|2.77||||0.0279|TWO_SIDED|95.0|1.11|6.88|||Mixed Models Analysis|||||6.88|1.11|0.0279
71900208|NCT02279524|143322574|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0878|TWO_SIDED|95.0|0.89|5.46|||Regression, Logistic|||||5.46|0.89|0.0878
71900209|NCT02279524|143322575|SUPERIORITY||Odds Ratio (OR)|0.14||||0.1008|TWO_SIDED|95.0|0.01|1.46|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||1.46|0.01|0.1008
71900210|NCT02279524|143322575|SUPERIORITY||Odds Ratio (OR)|0.63||||0.5693|TWO_SIDED|95.0|0.13|3.05|||Regression, Logistic||This analysis is limited by low number of events, and the duration of the study.|||3.05|0.13|0.5693
71817877|NCT00917267|143138672|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|0.39|1.25|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.25|0.39|<.001
71900211|NCT00137436|143322588|SUPERIORITY_OR_OTHER|||||||0.942||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.942
71900212|NCT00137436|143322588|SUPERIORITY_OR_OTHER|||||||0.323||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.323
71900213|NCT00137436|143322588|SUPERIORITY_OR_OTHER|||||||0.865||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.865
71900214|NCT00137436|143322588|SUPERIORITY_OR_OTHER|||||||0.873||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.873
71817878|NCT00917267|143138673|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|2.56||0.609|TWO_SIDED|95.0|-6.33|3.71|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||3.71|-6.33|0.609
71817879|NCT00917267|143138674|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.52||0.476|TWO_SIDED|95.0|-0.65|1.38|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.38|-0.65|0.476
71900215|NCT00137436|143322589|SUPERIORITY_OR_OTHER|||||||0.736||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.736
71900216|NCT00137436|143322589|SUPERIORITY_OR_OTHER|||||||0.962||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.962
71900217|NCT00137436|143322589|SUPERIORITY_OR_OTHER|||||||0.185||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.185
71900218|NCT00137436|143322589|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||1.000
71900219|NCT00137436|143322590|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.386
71900220|NCT00137436|143322590|SUPERIORITY_OR_OTHER|||||||0.904||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.904
71900221|NCT00137436|143322590|SUPERIORITY_OR_OTHER|||||||0.812||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.812
71900222|NCT00137436|143322590|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.490
71900223|NCT00137436|143322591|SUPERIORITY_OR_OTHER|||||||0.839||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.839
71900224|NCT00137436|143322591|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.219
71900225|NCT00137436|143322591|SUPERIORITY_OR_OTHER|||||||0.788||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.788
71900226|NCT00137436|143322591|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.164
71900227|NCT00137436|143322592|SUPERIORITY_OR_OTHER|||||||0.656||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.656
71900228|NCT00137436|143322592|SUPERIORITY_OR_OTHER|||||||0.628||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.628
71900229|NCT00137436|143322592|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.420
71679482|NCT05007041|142876988|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-0.96||||0.0037|TWO_SIDED|95.0|-8.94|7.1|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||The null hypothesis is simultaneous vaccination with RZV and allV4 is inferior (i.e., RZV and allV4 will have a higher proportion) to RZV and HD-IIV4 with regard to the proportion of adults with at least one severe (Grade 3) solicited local or systemic reactogenicity event on days 1-8 after RZV dose||7.10|-8.94|0.0037
71679483|NCT05007041|142876989|OTHER|Difference in proportions|Difference in proportions|-7.77|||||TWO_SIDED|95.0|-20.22|4.69||||||||4.69|-20.22|
71679484|NCT05007041|142876990|OTHER|Difference in proportions|Difference in proportions|2.59|||||TWO_SIDED|95.0|-7.29|12.47||||||||12.47|-7.29|
71679485|NCT05007041|142876991|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|1.74||||0.0031|TWO_SIDED|95.0|-4.04|7.77||The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Difference in proportions|||Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After SHINGRIX® Dose 1 in Each Study Group||7.77|-4.04|0.0031
71679486|NCT05007041|142876992|OTHER|Difference in proportions|Difference in proportions|-6.25|||||TWO_SIDED|95.0|-13.1|0.6|||Difference in proportions|||||0.60|-13.10|
71679487|NCT05007041|142876993|OTHER|Difference in proportions|Difference in proportions|5.89|||||TWO_SIDED|95.0|-1.32|13.11|||Difference in proportions|||||13.11|-1.32|
71679488|NCT05007041|142876994|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.|Difference in proportions|-4.17|||<|0.0001|TWO_SIDED|95.0|-10.9|2.47|||Difference in proportions|The upper bound of a site-stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.||||2.47|-10.90|<0.0001
71817880|NCT00917267|143138675|SUPERIORITY_OR_OTHER||Geometic Least Squares Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.807|TWO_SIDED|95.0|0.93|1.06|||Mixed Models Analysis|||TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.||1.06|0.93|0.807
71679489|NCT05007041|142876995|OTHER|Difference in proportions|Difference in proportions|-5.68|||||TWO_SIDED|95.0|-17.64|6.28|||Difference in proportions|||||6.28|-17.64|
71817881|NCT02960763|143138678|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.01||||||Equivalence of group|ANOVA|||||||0.010
71849604|NCT03205488|143212819|SUPERIORITY|||||||0.3895|||||||Fisher Exact|One-sided Fisher's Exact tested the proportion of participants who met tolerability between the Nilotinib 300 group to the Placebo group.||||||0.3895
71679490|NCT05007041|142876996|OTHER|Difference in proportions|Difference in proportions|-3.3|||||TWO_SIDED|95.0|-10.5|3.89|||Difference in proportions|||||3.89|-10.50|
71679491|NCT05007041|142876997|OTHER|Difference in proportions|Difference in proportions|-0.73|||||TWO_SIDED|95.0|-2.16|0.7|||Difference in proportions|||||0.70|-2.16|
71679492|NCT05007041|142876998|OTHER|The proportion and 95% exact binomial confidence interval between vaccine groups.|Difference in proportions|-2.88|||||TWO_SIDED|95.0|-6.36|0.6|||Difference in proportions|||||0.60|-6.36|
71679493|NCT00715728|142877026|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.||||||0.91||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|"Two 1-tailed tests were conducted to assess equivalence. See  Type of Statistical Test."||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||0.91
71679494|NCT00715728|142877026|EQUIVALENCE|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.001||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.||||<0.001
71817882|NCT02960763|143138678|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.004||||||augment with aripiprazole vs switch to bupropion|ANOVA|||||||0.004
71849605|NCT03205488|143212820|EQUIVALENCE|H0 : p1 = p2, where p represents the proportion of SAEs for each group. HA : p1 ≠ p2||||||1|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 150 group and the Placebo group.||||||1.00
71900230|NCT00137436|143322592|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
71817883|NCT02960763|143138678|SUPERIORITY|Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||||0.017||||||augment with bupropion vs switch to bupropion|ANOVA|||||||0.017
71817884|NCT02960763|143138678|SUPERIORITY|||||||0.65|||||||ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.650
71817885|NCT02960763|143138678|SUPERIORITY|||||||0.003||||||augmentation versus switch|ANOVA|||Repeated measure of 2\*2\*3 ANOVA with age (60 - 70, \> 70), time (baseline, end of Active phase of Step 1) by treatment group (3 levels). Tests were conducted with a Hochberg Step-down procedure. If the comparison with the lowest p-value \< 0.05/3 it is significant. If the second lowest p-value is also \< 0.05/2 then it also will be significant and if the third p-value is \< 0.05 then it also will be significant.||||0.003
71817886|NCT02960763|143138678|SUPERIORITY|For those who proceed to Step 2, analogous repeated measures 2\*2\*2 ANOVA will be used with a significance level of .05 for the time\*treatment group comparison.||||||0.385|||||||ANOVA|||||||0.385
71817887|NCT02960763|143138679|SUPERIORITY|||||||0.038||||||Group effect|generalized linear model with logistic l|||||||0.038
71817888|NCT02960763|143138679|SUPERIORITY|||||||0.021||||||augmentation with aripiprazole vs switch to bupropion|generalized linear model with logistic l|||||||0.021
71817889|NCT02960763|143138679|SUPERIORITY|||||||0.027||||||augmentation with bupropion vs switch to bupropion|generalized linear model with logistic l|||||||0.027
71817890|NCT02960763|143138679|SUPERIORITY|||||||0.934||||||Augmentation with aripiprazole v augmentation with bupropion|generalized linear model with logistic l|||||||0.934
71817891|NCT02960763|143138679|SUPERIORITY|||||||0.011||||||augmentation versus switch|generalized linear model with logistic l|||||||0.011
71817892|NCT02960763|143138679|SUPERIORITY|||||||0.5|||||||generalized linear model with logistic l|||||||0.500
71817893|NCT02960763|143138680|SUPERIORITY|||||||0.164||||||Cox models time to event comparing treatment arms.|Regression, Cox|||||||0.164
71817894|NCT02960763|143138680|SUPERIORITY|||||||0.103|||||||Regression, Cox|||||||0.103
71817895|NCT02960763|143138680|SUPERIORITY|||||||0.127|||||||Regression, Cox|||||||0.127
71817896|NCT02960763|143138680|SUPERIORITY|||||||0.524||||||Cox models to examine time to event comparing treatment arms.|Regression, Cox|||||||0.524
71817897|NCT00312858|143138694|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|0.7|||<|0.001||95.0|-1.4|3.8||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2.||3.8|-1.4|<0.001
71817898|NCT00312858|143138695|NON_INFERIORITY_OR_EQUIVALENCE|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound \>-10.0).|Risk Difference (RD)|-5.1||||0.013||95.0|-9.3|-1.4||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 - Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 - Arm 2 for participants with initial serostatus \<1.25 gpELISA units/mL||-1.4|-9.3|0.013
71817899|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 4||1.3|0.9|<0.001
71817900|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.8|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 6B||1.2|0.8|<0.001
71817901|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 9V||1.0|0.8|<0.001
71900231|NCT00137436|143322593|SUPERIORITY_OR_OTHER|||||||0.903||95.0|||||Wilcoxon rank-sum test|||C1D14 : C1D1||||0.903
71900232|NCT00137436|143322593|SUPERIORITY_OR_OTHER|||||||0.434||95.0|||||Wilcoxon rank-sum test|||C2.D1 : C1D1||||0.434
71900233|NCT00137436|143322593|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||Wilcoxon rank-sum test|||C2.D14 : C1D1||||0.687
71900234|NCT00137436|143322593|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Wilcoxon rank-sum test|||C3.D14 : C1D1||||0.296
71849606|NCT03205488|143212820|EQUIVALENCE|H0 : λ1 = λ2, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ2|Risk Ratio (RR)|0.4977||||0.5689|TWO_SIDED|95.0|0.0451|5.489|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 150 group and the placebo were also compared using a Poisson regression model||||5.489|0.0451|0.5689
71849607|NCT03205488|143212820|EQUIVALENCE|H0 : p1 = p3, where p represents the proportion of SAEs for each group. HA : p1 ≠ p3||||||0.61|||||||Fisher Exact|Fisher's Exact test compared a proportion of participants who experienced any serious adverse event in the Nilotinib 300 group and the Placebo group.||||||0.61
71849608|NCT03205488|143212820|EQUIVALENCE|H0 : λ1 = λ3, where λ represents the rate of SAEs for each group. HA : λ1 ≠ λ3|Risk Ratio (RR)|0.5206||||0.594|TWO_SIDED|95.0|0.0472|5.7409|||Regression, Poisson|Rates of serious adverse event between the Nilotinib 300 group and the placebo were also compared using a Poisson regression model||||5.7409|0.0472|0.5940
71849609|NCT03205488|143212821|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 150 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|1.05||||0.0001|ONE_SIDED|90.0|-0.78||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.78|0.0001
71849610|NCT03205488|143212821|NON_INFERIORITY|The hypotheses of interest (H0: δ ≤ -9.8 (7 x 1.4) vs. HA: δ \> -9.8) where δ represents the change from baseline to 6 months using the MDS-UPDRS Part III ON in the Nilotinib 300 mg treatment group. The hypotheses of interest were evaluated based on an assessment of parameter estimates from a non-linear mixed effects model, adjusted for a participant's Levodopa Equivalent Daily Dose (LEDD) at each time point.|Slope|0.93||||0.0001|ONE_SIDED|90.0|-0.89||||Mixed Models Analysis|||The key secondary objective is to conduct a futility analysis within each treatment group which examines the observed change in the MDS-UPDRS Part III ON within the two dose groups compared to previously reported changes from the Pagan et al (2016) study (NCT02281474).|||-0.89|0.0001
71849611|NCT03205488|143212821|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 1 month for the three treatment groups.||||||0.031|||||||Mixed Models Analysis|||Additional secondary objective #1 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 1 month.|In order to assess which group may be driving these findings, pairwise comparisons were also utilized (Nilotinib 150 vs PBO at 1 Month, Nilotinib 300 vs PBO at 1 month, Nilotinib 300 vs Nilotinib 150 at 1 month).|||0.031
71849612|NCT03205488|143212821|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. For this analysis, a separate LMM was constructed, modeling the change from final visit on study drug to the 30 and 60 day follow up visits, while adjusting for the MDS-UPDRS Part III ON scores at the final visit on study drug as well as the Levodopa Equivalent Daily Dose (LEDD) at each visit.||||||0.47|||||||Mixed Models Analysis|||Additional secondary objective #2 is to establish the degree of symptomatic effect of Nilotinib as measured by the change in the MDS\_UPDRS Part III ON score between the final visit on study drug and 30 days off study drug.||||0.47
71849613|NCT03205488|143212821|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using the same LMM as in the key secondary analysis, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.077|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III ON score between baseline and 6 months.|Pairwise comparisons were also examined for trends (Active 150 vs PBO at 6 Months, Active 300 vs PBO at 6 months).|||0.077
71849614|NCT03205488|143212821|EQUIVALENCE|H0 : β1 = β 2 = β 3, where β represents the slope for each group. HA : at least one β i ≠ β j. Using a similar LMM as in the key secondary analysis, except simplified to only include baseline, month 3 and month 6, a two degree of freedom test was used to test for any differences in the slopes from baseline to 6 months for the three treatment groups.||||||0.17|||||||Mixed Models Analysis|||Additional secondary objective #3 is to assess the impact of Nilotinib on the progression of PD disability as measured by the change in the MDS\_UPDRS Part III OFF score between baseline and 6 months.||||0.17
71849615|NCT04867382|143212822|SUPERIORITY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.27||0.63|TWO_SIDED||||||t-test, 2 sided|||||||.63
71849616|NCT04867382|143212823|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.27|TWO_SIDED||||||t-test, 2 sided|||||||0.27
71849617|NCT04867382|143212824|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.22||0.37|TWO_SIDED||||||t-test, 2 sided|||||||.37
71849618|NCT04867382|143212825|SUPERIORITY||Odds Ratio (OR)|1.75||||0.12|TWO_SIDED|95.0|0.86|3.57|||Regression, Logistic|||||3.57|0.86|.12
71849619|NCT01326455|143212826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED|95.0|||||Chi-squared|||Lancaster et. al. (2004) quoted the number 30 as a general sample size for a pilot study. Each arm of this study had 25 people (due to time constraints), giving a total of 75 people. The data were analyzed using t-tests for equality of means, a two-way analysis of variance (ANOVA), and chi-square. Significance was set at p \< 0.05.||||0.25
71817902|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 14||1.2|0.9|<0.001
71817903|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 18C||1.3|0.9|<0.001
71817904|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 19F||1.2|0.9|<0.001
71900235|NCT00738543|143322599|NON_INFERIORITY_OR_EQUIVALENCE|A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.||||<0.05
71900236|NCT00738543|143322601|NON_INFERIORITY_OR_EQUIVALENCE|The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.|||||<|0.05||95.0||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.||||<0.05
71900237|NCT05070429|143322655|SUPERIORITY||Maximum likelihood (MLE)|-0.035||||0.92|TWO_SIDED|95.0|-0.727|0.657||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|generalized linear model (GLM)|generalized linear model (GLM) with an identity link|Confidence intervals and p-values were obtained using a bias-corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare average daily hours of hearing aid use at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the primary outcome.||0.657|-0.727|0.92
71900238|NCT05070429|143322656|SUPERIORITY||Maximum likelihood (MLE)|-0.011||||0.87|TWO_SIDED|95.0|-0.147|0.125|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare treatment satisfaction at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.125|-0.147|0.87
71900239|NCT05070429|143322657|SUPERIORITY||Maximum likelihood (MLE)|0.059||||0.66|TWO_SIDED|95.0|-0.201|0.32|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare primary COSI goal achievement at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||0.320|-0.201|0.66
71849620|NCT01326455|143212827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Chi-squared|||||||0.47
71849621|NCT01326455|143212828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
71849622|NCT01326455|143212828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||||||<0.001
71849623|NCT01326455|143212828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.144|||||||ANOVA|||||||0.144
71849624|NCT01326455|143212829|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372|||||||ANOVA|||||||0.372
71849625|NCT01326455|143212830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.468|||||||Chi-squared|||||||0.468
71849626|NCT02008916|143212839|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0093|TWO_SIDED|95.0|1.24|4.69|||Regression, Logistic|||||4.69|1.24|0.0093
71849627|NCT02008916|143212839|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0037|TWO_SIDED|95.0|1.38|5.21|||Regression, Logistic|||||5.21|1.38|0.0037
71849628|NCT02008916|143212840|SUPERIORITY||Odds Ratio (OR)|2.59||||0.01|TWO_SIDED|95.0|1.26|5.35|||Regression, Logistic|||||5.35|1.26|0.0100
71849629|NCT02008916|143212840|SUPERIORITY||Odds Ratio (OR)|2.81||||0.0051|TWO_SIDED|95.0|1.36|5.78|||Regression, Logistic|||||5.78|1.36|0.0051
71849630|NCT02008916|143212841|SUPERIORITY||Relative treatment effect|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.68|0.38|<0.0001
71849631|NCT02008916|143212841|SUPERIORITY||Relative treatment effect|0.44|||<|0.0001|TWO_SIDED|95.0|0.33|0.6|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.|||0.60|0.33|<0.0001
71849632|NCT02008916|143212842|SUPERIORITY||Odds Ratio (OR)|4.46||||0.0002|TWO_SIDED|95.0|2.01|9.92|||Regression, Logistic|||||9.92|2.01|0.0002
71679495|NCT00715728|142877027|NON_INFERIORITY|The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C.|Mean Difference (Final Values)|-0.12||||0.018|TWO_SIDED|95.0|-0.37|0.14||P-value was adjusted for preoperative oral temperature and ASA physical status.|t-test, 1 sided||Non-inferiority will be established, at the 0.025 significance level, if the lower limit of a 95% confidence interval for the difference is above -0.5 °C.|Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.||0.14|-0.37|0.018
71849633|NCT02008916|143212842|SUPERIORITY||Odds Ratio (OR)|4.21||||0.0004|TWO_SIDED|95.0|1.89|9.38|||Regression, Logistic|||||9.38|1.89|0.0004
71849634|NCT02008916|143212843|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.39||0.0347|TWO_SIDED|95.0|-1.6|-0.06|||Mixed Models Analysis|||||-0.06|-1.60|0.0347
71849635|NCT02008916|143212843|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|0.39||0.0018|TWO_SIDED|95.0|-2.0|-0.46|||Mixed Models Analysis|||||-0.46|-2.00|0.0018
71849636|NCT02008916|143212847|SUPERIORITY||Odds Ratio (OR)|7.71||||0.0593|TWO_SIDED|95.0|0.92|64.42|||Regression, Logistic|||||64.42|0.92|0.0593
71849637|NCT02008916|143212847|SUPERIORITY||Odds Ratio (OR)|19.39||||0.0046|TWO_SIDED|95.0|2.49|150.79|||Regression, Logistic|||||150.79|2.49|0.0046
71849638|NCT01513447|143212889|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Fisher Exact|||||||0.67
71849639|NCT01513447|143212890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.0||||0.29|TWO_SIDED|95.0|-230.0|171.0|||Wilcoxon (Mann-Whitney)|||||171|-230|0.29
71849640|NCT01276509|143212891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.05|STANDARD_ERROR_OF_MEAN|0.121||0.3393|TWO_SIDED|90.0|-0.149|0.249|||Mixed Models Analysis|||Difference from placebo at Week 8||0.249|-0.149|0.3393
71900240|NCT05070429|143322658|SUPERIORITY||Maximum likelihood (MLE)|-1.96||||0.38|TWO_SIDED|95.0|-6.349|2.435|||generalized linear model (GLM)||To account for the non-normal distribution of the outcome, confidence intervals and p-values were obtained using a bias corrected and accelerated bootstrap resampling procedure with 10,000 replicates.|Used a weighted regression model with an identity link to compare hearing-specific quality of life at one-year post-randomization between participants assigned to the telehealth HHC or conventional HHC. Inverse probability of treatment weights will be calculated and included in the model for the secondary outcome.||2.435|-6.349|0.38
71679496|NCT01258075|142877028|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.21||0.5494|TWO_SIDED|95.0|-0.54|0.29|||ANCOVA|Based on a mixed effect ANCOVA model with treatment and previous type 2 diabetes treatment stratum as fixed effects and baseline as a covariate.||||0.29|-0.54|0.5494
71849641|NCT01276509|143212891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.117||0.1433|TWO_SIDED|90.0|-0.068|0.316|||Mixed Models Analysis|||Difference from placebo at Week 8||0.316|-0.068|0.1433
71849642|NCT01276509|143212891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.15|STANDARD_ERROR_OF_MEAN|0.113||0.0922|TWO_SIDED|90.0|-0.036|0.335|||Mixed Models Analysis|||Difference from placebo at Week 8||0.335|-0.036|0.0922
71849643|NCT01276509|143212891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.034|STANDARD_ERROR_OF_MEAN|0.117||0.3864|TWO_SIDED|90.0|-0.158|0.225|||Mixed Models Analysis|||Difference from placebo at Week 12||0.225|-0.158|0.3864
71849644|NCT01276509|143212891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.061|STANDARD_ERROR_OF_MEAN|0.117||0.3005|TWO_SIDED|90.0|-0.131|0.253|||Mixed Models Analysis|||Difference from placebo at Week 12||0.253|-0.131|0.3005
71849645|NCT01276509|143212891|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.011|STANDARD_ERROR_OF_MEAN|0.114||0.5385|TWO_SIDED|90.0|-0.198|0.176|||Mixed Models Analysis|||Difference from placebo at Week 12||0.176|-0.198|0.5385
71849646|NCT01276509|143212894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.124|STANDARD_ERROR_OF_MEAN|0.107||0.1234|TWO_SIDED|90.0|-0.052|0.299|||Mixed Models Analysis|||Difference from placebo at week 8||0.299|-0.052|0.1234
71849647|NCT01276509|143212894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.071|STANDARD_ERROR_OF_MEAN|0.099||0.2378|TWO_SIDED|90.0|-0.092|0.234|||Mixed Models Analysis|||Difference from placebo at week 8||0.234|-0.092|0.2378
71849648|NCT01276509|143212894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.102|STANDARD_ERROR_OF_MEAN|0.1||0.1529|TWO_SIDED|90.0|-0.062|0.266|||Mixed Models Analysis|||Difference from placebo at week 8||0.266|-0.062|0.1529
71849649|NCT01276509|143212894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.038|STANDARD_ERROR_OF_MEAN|0.112||0.3661|TWO_SIDED|90.0|-0.146|0.222|||Mixed Models Analysis|||Difference from placebo at week 12||0.222|-0.146|0.3661
71849650|NCT01276509|143212894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.055|STANDARD_ERROR_OF_MEAN|0.116||0.3169|TWO_SIDED|90.0|-0.136|0.246|||Mixed Models Analysis|||Difference from placebo at week 12||0.246|-0.136|0.3169
71849651|NCT01276509|143212894|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.066|STANDARD_ERROR_OF_MEAN|0.111||0.2755|TWO_SIDED|90.0|-0.116|0.248|||Mixed Models Analysis|||Difference from placebo at week 12||0.248|-0.116|0.2755
71849652|NCT03854734|143212908|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|1.0|1.25|||Regression, Logistic|||Analysis for vaccine intention of Tdap||1.25|1.00|
71849653|NCT03854734|143212908|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|1.0|1.29|||Regression, Logistic|||Analysis for vaccine intention of MCV||1.29|1.00|
71849654|NCT03854734|143212908|SUPERIORITY|Generalized estimating equations (GEE) model using the framework of a log-binomial logistic regression model.|Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.96|1.14|||Regression, Logistic|||Analysis for vaccine intention of HPV||1.14|0.96|
71849655|NCT00666705|143212961|SUPERIORITY_OR_OTHER||Ratio (percent)|85.76||||||90.0|79.89|92.07|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).||92.07|79.89|
71849656|NCT00666705|143212962|SUPERIORITY_OR_OTHER||Ratio (percent)|79.48||||||90.0|67.19|94.02|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).||94.02|67.19|
71849657|NCT00666705|143212963|SUPERIORITY_OR_OTHER||Ratio (percent)|63.25||||||90.0|44.27|90.39|||Mixed Models Analysis|Natural log transformed AUCτ was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.||90.39|44.27|
71849658|NCT00666705|143212964|SUPERIORITY_OR_OTHER||Ratio (percent)|90.33||||||90.0|85.28|95.68|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.||95.68|85.28|
71849659|NCT00666705|143212965|SUPERIORITY_OR_OTHER||Ratio (percent)|66.77||||||90.0|41.22|108.15|||Mixed Models Analysis|Natural log transformed Cmax was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.||108.15|41.22|
71849660|NCT00666705|143212966|SUPERIORITY_OR_OTHER||ratio (percent)|72.42||||||90.0|57.82|90.71|||Mixed Models Analysis|Natural log transformed C12 was analyzed using a mixed effect model with treatment as a fixed effect and subject as a random effect.|Ratio (percent) (Test/Reference) of Adjusted Geometric Means|||90.71|57.82|
71849661|NCT01109979|143212967|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.04
71849662|NCT01228734|143212968|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.629|||<|0.001|TWO_SIDED|95.0|0.498|0.794|||Log Rank|||||0.794|0.498|<0.001
71849663|NCT02580799|143212974|SUPERIORITY_OR_OTHER||||||=|0.137|TWO_SIDED||||||Chi-squared|||Site A: Site B variability assessment||||=0.137
71849664|NCT02580799|143212974|SUPERIORITY_OR_OTHER||||||=|0.454|TWO_SIDED||||||Chi-squared|||Site A: Site C variability assessment||||=0.454
71849665|NCT02580799|143212974|SUPERIORITY_OR_OTHER||||||=|0.211|TWO_SIDED||||||Chi-squared|||Site A: Site D variability assessment||||=0.211
71849666|NCT02580799|143212974|SUPERIORITY_OR_OTHER||||||=|0.294|TWO_SIDED||||||Chi-squared|||Site A: Site E variability assessment||||=0.294
71849667|NCT02580799|143212976|SUPERIORITY_OR_OTHER||||||=|0.054|TWO_SIDED||||||Chi-squared|||Site B: Site C variability assessment||||=0.054
71849668|NCT02580799|143212976|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Chi-squared|||Site B: Site D variability assessment||||=1.000
71849669|NCT02580799|143212976|SUPERIORITY_OR_OTHER||||||=|0.968|TWO_SIDED||||||Chi-squared|||Site B: Site E variability assessment||||=0.968
71900241|NCT00943319|143322661|OTHER||Median Survival time|161.0|||||TWO_SIDED|95.0|121.0|305.0|||Product limit survival estimate|||||305|121|
71900242|NCT00943319|143322662|OTHER||Median Disease Free Survival Time|172.0|||||TWO_SIDED|95.0|85.0|436.0||||||Estimated median survival time||436|85|
71900243|NCT02043301|143322663|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|120.96|||||TWO_SIDED|90.0|101.99|143.45|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||143.45|101.99|
71900244|NCT02043301|143322663|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|94.93|||||TWO_SIDED|90.0|80.2|112.38|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||112.38|80.20|
71900245|NCT02043301|143322664|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|127.65|||||TWO_SIDED|90.0|107.19|152.02|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||152.02|107.19|
71900246|NCT02043301|143322664|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|86.16|||||TWO_SIDED|90.0|72.49|102.4|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||102.40|72.49|
71900247|NCT02043301|143322665|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|129.98|||||TWO_SIDED|90.0|106.76|158.27|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Thigh (Test) versus Abdomen (Reference)||158.27|106.76|
71900248|NCT02043301|143322665|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|100.27|||||TWO_SIDED|90.0|82.54|121.82|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed body weight as a covariate.||Upper Arm (Test) versus Abdomen (Reference)||121.82|82.54|
71849670|NCT02580799|143212989|SUPERIORITY_OR_OTHER||||||=|0.246|TWO_SIDED||||||Chi-squared|||Site C: Site D variability assessment||||=0.246
71849671|NCT02580799|143212989|SUPERIORITY_OR_OTHER||||||=|0.032|TWO_SIDED||||||Chi-squared|||Site C: Site E variability assessment||||=0.032
71849672|NCT02580799|143212989|SUPERIORITY_OR_OTHER||||||=|0.007|TWO_SIDED||||||Chi-squared|||Site D: Site E variability assessment||||=0.007
71849673|NCT02580799|143212991|SUPERIORITY_OR_OTHER||||||=|0.988|TWO_SIDED||||||Chi-squared|||Abroad: Site A variability assessment||||=0.988
71849674|NCT02580799|143212991|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Chi-squared|||Abroad: Site B variability assessment||||=0.008
71849675|NCT02580799|143212991|SUPERIORITY_OR_OTHER||||||=|0.031|TWO_SIDED||||||Chi-squared|||Abroad: Site C variability assessment||||=0.031
71849676|NCT02580799|143212991|SUPERIORITY_OR_OTHER||||||=|0.554|TWO_SIDED||||||Chi-squared|||Abroad: Site D variability assessment||||=0.554
71849677|NCT02580799|143212991|SUPERIORITY_OR_OTHER||||||=|0.709|TWO_SIDED||||||Chi-squared|||Abroad: Site E variability assessment||||=0.709
71849678|NCT03456856|143212995|SUPERIORITY||least square mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.7||0.013|TWO_SIDED|95.0|-8.0|-1.0|||repeated measures linear model|||The estimated mean treatment difference (95% CI) takes into account a presumed -5 bpm change from baseline heart rate in the absence of ivabradine (as seen in the placebo group in the SHIFT study, (NCT02441218, PMID 20801500).||-1.0|-8.0|0.013
71849679|NCT02137785|143213032|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.||||0.0001
71849680|NCT02137785|143213033|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
71849681|NCT02137785|143213034|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction||||||<0.0001
71849682|NCT02137785|143213035|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||||||0.0001
71849683|NCT02841449|143213122|OTHER|||||||0.886|||||||t-test, 2 sided|paired sample||||||0.886
71849684|NCT02841449|143213122|OTHER|||||||0.43||||||The above is the trial\*time interaction. trial, p = 0.627; time, p \< 0.001|ANOVA|repeated measures||||||0.430
71849685|NCT02841449|143213123|OTHER|||||||0.369|||||||t-test, 2 sided|paired samples||||||0.369
71849686|NCT02841449|143213123|OTHER|||||||0.859||||||The above is the trial\*time interaction. trial p = 0.200; time p \< 0.001|ANOVA|repeated measures||||||0.859
71849687|NCT02841449|143213124|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||<0.001
71849688|NCT02841449|143213124|OTHER|||||||0.261||||||The above is the trial\*time interaction. trial p = 0.002; time p = 0.282|ANOVA|repeated measures||||||0.261
71849689|NCT02841449|143213125|OTHER|||||||0.736|||||||t-test, 2 sided|paired samples||||||0.736
71849690|NCT02841449|143213126|OTHER|||||||0.542|||||||t-test, 2 sided|paired samples||||||0.542
71849691|NCT02841449|143213127|OTHER|||||||0.4|||||||t-test, 2 sided|paired samples||||||0.400
71849692|NCT02841449|143213128|OTHER|||||||0.646|||||||ANOVA|repeated measures||Visual analogue scale for thirst||||0.646
71849693|NCT02841449|143213128|OTHER|||||||0.403|||||||ANOVA|repeated measures||visual analogue scale for desire for savoury||||0.403
71849694|NCT02841449|143213128|OTHER|||||||0.022|||||||ANOVA|repeated measures||visual analogue scale for desire for salt||||0.022
71849695|NCT02841449|143213128|OTHER|||||||0.849|||||||ANOVA|repeated measures||visual analogue scale for hunger||||0.849
71849696|NCT02841449|143213128|OTHER|||||||0.062|||||||ANOVA|repeated measures||visual analogue scale for fullness||||0.062
71849697|NCT02841449|143213128|OTHER|||||||0.549|||||||ANOVA|repeated measures||visual analogue scale for how much participants felt they could eat||||0.549
71849698|NCT02841449|143213128|OTHER|||||||0.402|||||||ANOVA|repeated measures||visual analogue scale for sweet desire||||0.402
71849699|NCT02841449|143213128|OTHER|||||||0.138|||||||ANOVA|repeated measures||visual analogue scale for fatty food desire||||0.138
71849700|NCT02841449|143213129|OTHER|||||||0.055||||||Above is trial\*time effect. trial p = 0.135; time p = 0.011|ANOVA|repeated measures||||||0.055
71849701|NCT02841449|143213130|OTHER|||||||0.226|||||||t-test, 2 sided|paired sample||||||0.226
71849702|NCT02841449|143213131|OTHER||||||<|0.001|||||||t-test, 2 sided|paired samples||||||< 0.001
71849703|NCT00346398|143213163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.28|TWO_SIDED|95.0|0.5|10.5||Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||10.5|0.5|0.28
71900249|NCT02043301|143322670|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.35|||||TWO_SIDED|90.0|84.659|111.943|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||111.943|84.659|
71900250|NCT02043301|143322670|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|103.96|||||TWO_SIDED|90.0|90.405|119.557|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||119.557|90.405|
71900251|NCT02043301|143322671|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
71900252|NCT02043301|143322671|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
71900253|NCT02043301|143322672|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||TWO_SIDED|90.0|86.558|108.926|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||108.926|86.558|
71900254|NCT02043301|143322672|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||TWO_SIDED|90.0|83.359|104.912|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||104.912|83.359|
71900255|NCT02043301|143322674|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.51|||||TWO_SIDED|90.0|97.555|107.717|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.717|97.555|
71900256|NCT02043301|143322674|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.02|||||TWO_SIDED|90.0|97.131|107.151|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||107.151|97.131|
71900257|NCT02043301|143322675|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
71849704|NCT00346398|143213164|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.85|TWO_SIDED|95.0|0.2|6.1||Odds Ratios are calculated using unadjusted exact logistic regression with mid p-value to adjust for the discreteness of the distribution|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.||6.1|0.2|0.85
71849705|NCT00346398|143213165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.8||||0.28|TWO_SIDED|95.0|0.6|5.6||P-value is calculated using a log-rank test|Regression, Logistic||Hazard ratio and 95% confidence intervals are calculated using an unadjusted Cox regression|||5.6|0.6|0.28
71849706|NCT03979040|143213166|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5||||P value = .025 (one-sided) and sign test below|Sign test|||||||.025
71849707|NCT03979040|143213167|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
71849708|NCT03979040|143213168|NON_INFERIORITY|A non-inferiority margin of -.5 was set for outcome analysis with a one-sided alpha of .025.|Mean Difference (Net)|-0.5||||0.025|ONE_SIDED|97.5|||||Sign test|||||||.025
71849709|NCT02607956|143213169|NON_INFERIORITY|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-3.5|||||TWO_SIDED|95.002|-7.9|1.0|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.0|-7.9|
71849710|NCT02607956|143213169|SUPERIORITY|||||||0.12|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.12
71849711|NCT02607956|143213170|OTHER||Difference in Percentages|-2.3|||||TWO_SIDED|95.0|-7.9|3.2|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.2|-7.9|
71849712|NCT02607956|143213170|OTHER|||||||0.41|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.41
71849713|NCT02607956|143213171|OTHER||Difference in Percentages|-1.9|||||TWO_SIDED|95.0|-7.8|3.9|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.9|-7.8|
71849714|NCT02607956|143213171|OTHER|||||||0.52|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.52
71849715|NCT02607956|143213172|OTHER||Difference in Percentages|-3.9|||||TWO_SIDED|95.0|-9.4|1.5|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||1.5|-9.4|
71849716|NCT02607956|143213172|OTHER|||||||0.16|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.16
71849717|NCT02607956|143213173|OTHER||Difference in Percentages|-2.5|||||TWO_SIDED|95.0|-8.8|3.8|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||3.8|-8.8|
71900258|NCT02043301|143322675|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
71900259|NCT02043301|143322676|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||TWO_SIDED|90.0|60.883|102.735|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||102.735|60.883|
71900260|NCT02043301|143322676|SUPERIORITY_OR_OTHER|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||TWO_SIDED|90.0|70.269|118.248|||ANCOVA|ANCOVA model with treatment group as a fixed effect and log-transformed baseline LDL-C as a covariate.||||118.248|70.269|
71900261|NCT00883558|143322697|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.|LS Mean Difference|3.06||||0.3217|ONE_SIDED|95.0||14.11|||Mixed Models Analysis|Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.||A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.||14.11||0.3217
71900262|NCT02436577|143322700|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|93.16|||||TWO_SIDED|90.0|85.8|101.15|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.15|85.80|
71900263|NCT02436577|143322700|SUPERIORITY_OR_OTHER||Geometric mean ratio|93.67|||||TWO_SIDED|90.0|87.88|99.84|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.84|87.88|
71900264|NCT02436577|143322700|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.79|||||TWO_SIDED|90.0|88.27|106.14|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||106.14|88.27|
71900265|NCT02436577|143322700|SUPERIORITY_OR_OTHER||Geometric mean ratio|92.32|||||TWO_SIDED|90.0|85.04|100.23|||ANOVA|||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||100.23|85.04|
71900266|NCT02436577|143322701|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.76|||||TWO_SIDED|90.0|94.46|101.18|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.18|94.46|
71900267|NCT02436577|143322701|SUPERIORITY_OR_OTHER||Geometric Mean ratio|96.38|||||TWO_SIDED|90.0|93.24|99.63|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.63|93.24|
71900268|NCT02436577|143322701|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.43|||||TWO_SIDED|90.0|94.75|102.25|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.25|94.75|
71900269|NCT02436577|143322701|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.59|98.85|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||98.85|91.59|
71900270|NCT02436577|143322702|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|97.75|||||TWO_SIDED|90.0|94.4|101.21|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||101.21|94.40|
71817905|NCT00312858|143138696|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is \>0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|TWO_SIDED|95.0|1.0|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 23F||1.3|1.0|<0.001
71900271|NCT02436577|143322702|SUPERIORITY_OR_OTHER||Geometric mean ratio|96.5|||||TWO_SIDED|90.0|93.31|99.8|||ANOVA|||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.||99.80|93.31|
71900272|NCT02436577|143322702|SUPERIORITY_OR_OTHER||Geometric mean ratio|98.46|||||TWO_SIDED|90.0|94.85|102.2|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||102.20|94.85|
71900273|NCT02436577|143322702|SUPERIORITY_OR_OTHER||Geometric mean ratio|95.47|||||TWO_SIDED|90.0|91.99|99.08|||ANOVA|||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.||99.08|91.99|
71900274|NCT03703375|143322716|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0541|TWO_SIDED|95.0|0.41|1.09|||Stratified Cox|Stratified Cox proportional hazards model||||1.09|0.41|0.0541
71900275|NCT03703375|143322717|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0166|TWO_SIDED|95.0|0.32|0.96|||Efron|Stratified Cox proportional hazards model||||0.96|0.32|0.0166
71900276|NCT03703375|143322718|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2139|TWO_SIDED|95.0|0.51|1.33|||Stratified Cox|Stratified Cox proportional hazards model||||1.33|0.51|0.2139
71900277|NCT00903032|143322753|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided||||||0.003|TWO_SIDED||||||Chi-squared|||Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.||||0.003
71900278|NCT00623467|143322772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03|STANDARD_DEVIATION|0.86|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900279|NCT00623467|143322772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71849718|NCT02607956|143213173|OTHER|||||||0.44|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.44
71849719|NCT02607956|143213174|OTHER||Difference in Percentages|-1.1|||||TWO_SIDED|95.0|-7.4|5.3|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).|||5.3|-7.4|
71849720|NCT02607956|143213174|OTHER|||||||0.74|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. \> 100,000 copies/mL) and region stratum (US vs. Ex-US).||||||0.74
71849721|NCT02607956|143213175|OTHER||Difference in LSM|0.08||||0.081|TWO_SIDED|95.0|-0.01|0.17|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.17|-0.01|0.081
71849722|NCT02607956|143213176|OTHER||Difference in LSM|0.06||||0.18|TWO_SIDED|95.0|-0.03|0.15|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.15|-0.03|0.18
71900280|NCT00623467|143322772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|STANDARD_DEVIATION|0.54|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900281|NCT00623467|143322773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.8|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900282|NCT00623467|143322773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.94|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900283|NCT00623467|143322773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08|STANDARD_DEVIATION|0.74|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71849723|NCT02607956|143213177|OTHER||Difference in LSM|0.09||||0.054|TWO_SIDED|95.0|0.0|0.18|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||0.18|0.00|0.054
71849724|NCT02607956|143213178|OTHER||Difference in LSM|-23.0||||0.096|TWO_SIDED|95.0|-49.0|4.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||4|-49|0.096
71849725|NCT02607956|143213179|OTHER||Difference in LSM|-47.0||||0.008|TWO_SIDED|95.0|-81.0|-12.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.|||-12|-81|0.008
71849726|NCT02607956|143213180|OTHER||Difference in LSM|-14.0||||0.48|TWO_SIDED|95.0|-52.0|25.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.|||25|-52|0.48
71849727|NCT00696241|143213226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.75|||<|0.001||95.0|-13.17|-8.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-8.34|-13.17|<0.001
71849728|NCT00696241|143213226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.08|||<|0.001|TWO_SIDED|95.0|-14.48|-9.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.67|-14.48|<0.001
71849729|NCT00696241|143213226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|||<|0.001|TWO_SIDED|95.0|-15.62|-10.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-10.81|-15.62|<0.001
71900284|NCT00623467|143322774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_DEVIATION|0.82|<|0.0001||||||for contrast enhancement|paired t-test|||||||<0.0001
71900285|NCT00623467|143322774|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.12|STANDARD_DEVIATION|0.74|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900286|NCT00623467|143322774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.57|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900287|NCT00623467|143322775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.94|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900288|NCT00623467|143322775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|0.71|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900289|NCT00623467|143322775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.53|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900290|NCT00623467|143322776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|5.31|||||||||||for BR1|||||
71900291|NCT00623467|143322776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_DEVIATION|8.77|||||||||||for BR2|||||
71900292|NCT00623467|143322776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|4.2|||||||||||for BR3|||||
71900293|NCT00623467|143322776|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.32|STANDARD_DEVIATION|3.53|||TWO_SIDED|95.0|-0.07|0.704|||95% confidence interval for paired means||confidence interval provided for average reader, lower limit is compared to noninferiority margin|||0.704|-0.070|
71849730|NCT00696241|143213226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.687|TWO_SIDED|95.0|-1.55|2.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||2.35|-1.55|0.687
71849731|NCT00696241|143213226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.352|TWO_SIDED|95.0|-2.87|1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||1.02|-2.87|0.352
71849732|NCT00696241|143213226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06||||0.038|TWO_SIDED|95.0|-4.0|-0.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.12|-4.00|0.038
71849733|NCT00696241|143213227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.23|||<|0.001|TWO_SIDED|95.0|-15.45|-9.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.00|-15.45|<0.001
71849734|NCT00696241|143213227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.42|||<|0.001|TWO_SIDED|95.0|-15.64|-9.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-9.20|-15.64|<0.001
71849735|NCT00696241|143213227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.53|||<|0.001|TWO_SIDED|95.0|-18.74|-12.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-12.31|-18.74|<0.001
71849736|NCT00696241|143213227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59||||0.662|TWO_SIDED|95.0|-2.05|3.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.22|-2.05|0.662
71849737|NCT00696241|143213227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.768|TWO_SIDED|95.0|-2.24|3.03||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||3.03|-2.24|0.768
71900294|NCT00623467|143322777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|0.68|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
71900295|NCT00623467|143322777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.65|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900296|NCT00623467|143322778|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|1.6||||95.0|0.03|0.381|||||lower limit of the confidence interval is compared to the noninferiority margin|||0.381|0.030|
71900297|NCT00623467|143322779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|1.47|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900298|NCT00623467|143322779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.75|STANDARD_DEVIATION|1.34|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900299|NCT00623467|143322779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_DEVIATION|1.03|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71849738|NCT00696241|143213227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.043|TWO_SIDED|95.0|-5.34|-0.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA|||||-0.09|-5.34|0.043
71849739|NCT00696241|143213228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.78|||<|0.001|TWO_SIDED|95.0|-8.34|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.34|<0.001
71849740|NCT00696241|143213228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68|||<|0.001|TWO_SIDED|95.0|-9.24|-6.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.13|-9.24|<0.001
71900300|NCT00623467|143322780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.49|STANDARD_DEVIATION|1.38|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900301|NCT00623467|143322780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_DEVIATION|1.6|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900302|NCT00623467|143322780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_DEVIATION|1.25|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900303|NCT00623467|143322781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.39|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900304|NCT00623467|143322781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|1.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900305|NCT00623467|143322781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|STANDARD_DEVIATION|1.02|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900306|NCT00623467|143322782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|1.32|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900307|NCT00623467|143322782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900308|NCT00623467|143322782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.99|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900309|NCT00623467|143322783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|0.48|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900310|NCT00623467|143322783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||<0.0001
71900311|NCT00623467|143322783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900312|NCT00623467|143322784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.35|STANDARD_DEVIATION|0.4|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900313|NCT00623467|143322784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27|STANDARD_DEVIATION|0.38|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900314|NCT00623467|143322784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_DEVIATION|0.34|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900315|NCT00623467|143322785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.21|STANDARD_DEVIATION|0.37|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900316|NCT00623467|143322785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_DEVIATION|0.45|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900317|NCT00623467|143322785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.3|<|0.0001||||||for internal morphology|paired t test|||||||<0.0001
71900318|NCT00623467|143322786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.32|STANDARD_DEVIATION|0.34|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71900319|NCT00623467|143322786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_DEVIATION|0.3|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71900320|NCT00623467|143322786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900321|NCT00623467|143322788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|1.0|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
71900322|NCT00623467|143322788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.9|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900323|NCT00623467|143322789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|STANDARD_DEVIATION|0.63|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
71900324|NCT00623467|143322789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_DEVIATION|0.64|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71900325|NCT00623467|143322790|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.4||||0.0002|||||||McNemar|||||||0.0002
71900326|NCT00623467|143322791|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.0001|||||||McNemar|||||||0.0001
71900327|NCT00623467|143322792|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0285|||||||McNemar|||||||0.0285
71900328|NCT00623467|143322793|SUPERIORITY_OR_OTHER||Risk Difference (RD)|8.5||||0.0004|||||||McNemar|||||||0.0004
71900329|NCT00623467|143322794|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-12.5||||0.0588|||||||McNemar|||||||0.0588
71900330|NCT00623467|143322795|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.0093|||||||McNemar|||||||0.0093
71900331|NCT00623467|143322796|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.6||||0.0003|||||||McNemar|||||||0.0003
71900332|NCT00623467|143322797|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||1|||||||McNemar|||||||1.0000
71900333|NCT00623467|143322798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.8||||0.0016|||||||McNemar|||||||0.0016
71900334|NCT00623467|143322799|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.9||||0.0253|||||||McNemar|||||||0.0253
71900335|NCT00623467|143322800|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.5||||0.0253|||||||McNemar|||||||0.0253
71900336|NCT00623467|143322801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.7|<|0.0001|||||||paired t-test|||||||< 0.0001
71900337|NCT00623467|143322802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84|STANDARD_DEVIATION|0.81|<|0.0001|||||||paired t-test|||||||< 0.0001
71900338|NCT01809262|143322815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.02||0.0005||95.0|0.031|0.109|||ANCOVA|||||0.109|0.031|0.0005
71900339|NCT01809262|143322815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.06|0.138|||ANCOVA|||||0.138|0.060|<0.0001
71900340|NCT01809262|143322815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.074|0.152|||ANCOVA|||||0.152|0.074|<0.0001
71900341|NCT01809262|143322815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.08|0.158|||ANCOVA|||||0.158|0.080|<0.0001
71900342|NCT01809262|143322816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.077|0.139|||ANCOVA|||||0.139|0.077|<0.0001
71900343|NCT01809262|143322816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.124|0.186|||ANCOVA|||||0.186|0.124|<0.0001
71900344|NCT01809262|143322816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.13|0.192|||ANCOVA|||||0.192|0.130|<0.0001
71900345|NCT01809262|143322816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.161|0.223|||ANCOVA|||||0.223|0.161|<0.0001
71900346|NCT01809262|143322817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.068|0.131|||ANCOVA|||||0.131|0.068|<0.0001
71900347|NCT01809262|143322817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.107|0.171|||ANCOVA|||||0.171|0.107|<0.0001
71900348|NCT01809262|143322817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.122|0.185|||ANCOVA|||||0.185|0.122|<0.0001
71900349|NCT01809262|143322817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.152|0.215|||ANCOVA|||||0.215|0.152|<0.0001
71900350|NCT01809262|143322818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.056|0.117|||ANCOVA|||||0.117|0.056|<0.0001
71900351|NCT01809262|143322818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.087|0.148|||ANCOVA|||||0.148|0.087|<0.0001
71900352|NCT01809262|143322818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.107|0.168|||ANCOVA|||||0.168|0.107|<0.0001
71900353|NCT01809262|143322818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001||95.0|0.132|0.193|||ANCOVA|||||0.193|0.132|<0.0001
71900354|NCT01809262|143322819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.041|0.108|||ANCOVA|||||0.108|0.041|<0.0001
71817906|NCT01108510|143138729|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was \> -12%.|Difference in percentages|-2.2|||||TWO_SIDED|95.2|-7.4|3.0|||||Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.||3.0|-7.4|
71849741|NCT00696241|143213228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||<|0.001|TWO_SIDED|95.0|-9.47|-6.36||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.36|-9.47|<0.001
71849742|NCT00696241|143213228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.679|TWO_SIDED|95.0|-0.99|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-0.99|0.679
71849743|NCT00696241|143213228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.319|TWO_SIDED|95.0|-1.89|0.62||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.62|-1.89|0.319
71849744|NCT00696241|143213228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.172|TWO_SIDED|95.0|-2.13|0.38||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.38|-2.13|0.172
71849745|NCT00696241|143213229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.02|||<|0.001|TWO_SIDED|95.0|-8.83|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.22|-8.83|<0.001
71849746|NCT00696241|143213229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.07|||<|0.001|TWO_SIDED|95.0|-8.87|-5.27||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.27|-8.87|<0.001
71849747|NCT00696241|143213229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.62|||<|0.001|TWO_SIDED|95.0|-10.42|-6.82||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.82|-10.42|<0.001
71849748|NCT00696241|143213229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.908|TWO_SIDED|95.0|-1.39|1.56||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.56|-1.39|0.908
71849749|NCT00696241|143213229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.956|TWO_SIDED|95.0|-1.43|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.52|-1.43|0.956
71679497|NCT01500213|142877040|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.043|TWO_SIDED|95.0|1.0|2.1||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.1|1.0|0.043
71849750|NCT00696241|143213229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.044|TWO_SIDED|95.0|-2.98|-0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.04|-2.98|0.044
71849751|NCT00696241|143213230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.03|||<|0.001|TWO_SIDED|95.0|-13.59|-8.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.48|-13.59|<0.001
71849752|NCT00696241|143213230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|||<|0.001|TWO_SIDED|95.0|-14.75|-9.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.65|-14.75|<0.001
71849753|NCT00696241|143213230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.41|||<|0.001|TWO_SIDED|95.0|-15.97|-10.86||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-10.86|-15.97|<0.001
71849754|NCT00696241|143213230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.879|TWO_SIDED|95.0|-1.9|2.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.22|-1.90|0.879
71900355|NCT01809262|143322819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.096|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.062|0.13|||ANCOVA|||||0.130|0.062|<0.0001
71849755|NCT00696241|143213230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.334|TWO_SIDED|95.0|-3.07|1.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.04|-3.07|0.334
71849756|NCT00696241|143213230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.034|TWO_SIDED|95.0|-4.28|-0.16||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.16|-4.28|0.034
71849757|NCT00696241|143213231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|||<|0.001|TWO_SIDED|95.0|-8.79|-5.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.45|-8.79|<0.001
71849758|NCT00696241|143213231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.84|||<|0.001|TWO_SIDED|95.0|-9.51|-6.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.18|-9.51|<0.001
71849759|NCT00696241|143213231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.28|||<|0.001|TWO_SIDED|95.0|-9.94|-6.61||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.61|-9.94|<0.001
71849760|NCT00696241|143213231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.877|TWO_SIDED|95.0|-1.24|1.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.45|-1.24|0.877
71817907|NCT01108510|143138730|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-1.4|||||TWO_SIDED|95.0|-7.6|4.7|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.7|-7.6|
71849761|NCT00696241|143213231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.369|TWO_SIDED|95.0|-1.96|0.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.73|-1.96|0.369
71679498|NCT01500213|142877041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.233|TWO_SIDED|95.0|0.8|2.0||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|0.8|0.233
71817908|NCT01108510|143138731|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-2.1|||||TWO_SIDED|95.0|-8.7|4.5|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||4.5|-8.7|
71817909|NCT01108510|143138732|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.0|||||TWO_SIDED|95.0|-22.2|6.3|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.|||6.3|-22.2|
71849762|NCT00696241|143213231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.126|TWO_SIDED|95.0|-2.39|0.3||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.30|-2.39|0.126
71849763|NCT00696241|143213232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.13|||<|0.001|TWO_SIDED|95.0|-12.79|-7.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-7.48|-12.79|<0.001
71849764|NCT00696241|143213232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.43|||<|0.001|TWO_SIDED|95.0|-14.07|-8.78||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.78|-14.07|<0.001
71849765|NCT00696241|143213232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.38|||<|0.001|TWO_SIDED|95.0|-15.03|-9.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.73|-15.03|<0.001
71849766|NCT00696241|143213232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.346|TWO_SIDED|95.0|-1.12|3.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||3.18|-1.12|0.346
71849767|NCT00696241|143213232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.811|TWO_SIDED|95.0|-2.4|1.88||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.88|-2.40|0.811
71849768|NCT00696241|143213232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.267|TWO_SIDED|95.0|-3.35|0.93||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.93|-3.35|0.267
71849769|NCT00696241|143213233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03|||<|0.001|TWO_SIDED|95.0|-7.84|-4.21||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.21|-7.84|<0.001
71849770|NCT00696241|143213233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.94|||<|0.001|TWO_SIDED|95.0|-8.75|-5.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.13|-8.75|<0.001
71849771|NCT00696241|143213233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.65|-5.03||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.03|-8.65|<0.001
71900356|NCT01809262|143322819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.089|0.156|||ANCOVA|||||0.156|0.089|<0.0001
71900357|NCT01809262|143322819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.107|0.174|||ANCOVA|||||0.174|0.107|<0.0001
71900358|NCT01809262|143322820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.084|0.158|||ANCOVA|||||0.158|0.084|<0.0001
71900359|NCT01809262|143322820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.129|0.203|||ANCOVA|||||0.203|0.129|<0.0001
71900360|NCT01809262|143322820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.139|0.214|||ANCOVA|||||0.214|0.139|<0.0001
71900361|NCT01809262|143322820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||ANCOVA|||||0.250|0.176|<0.0001
71849772|NCT00696241|143213233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64||||0.394|TWO_SIDED|95.0|-0.83|2.1||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.10|-0.83|0.394
71900362|NCT01809262|143322821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.306|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.21|0.402|||ANCOVA|||||0.402|0.210|<0.0001
71900363|NCT01809262|143322821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.258|0.452|||ANCOVA|||||0.452|0.258|<0.0001
71900364|NCT01809262|143322821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.253|0.447|||ANCOVA|||||0.447|0.253|<0.0001
71900365|NCT01809262|143322821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.455|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001||95.0|0.359|0.551|||ANCOVA|||||0.551|0.359|<0.0001
71900366|NCT02064439|143322829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.0001|TWO_SIDED|95.0|0.2|0.59||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.59|0.20|0.0001
71900367|NCT02064439|143322829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|98.0|0.14|0.47||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.47|0.14|<0.0001
71900368|NCT02064439|143322829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.4328|TWO_SIDED|95.0|0.65|2.75||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.75|0.65|0.4328
71900369|NCT02064439|143322830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.01||||0.3235|TWO_SIDED|95.0|0.5|8.04||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||8.04|0.50|0.3235
71900370|NCT02064439|143322830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.5005|TWO_SIDED|95.0|0.39|6.84||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||6.84|0.39|0.5005
71900371|NCT02064439|143322830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.7337|TWO_SIDED|95.0|0.37|4.03||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||4.03|0.37|0.7337
71900372|NCT02064439|143322831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.2|0.57||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.57|0.20|<0.0001
71900373|NCT02064439|143322831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.19|0.54||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||0.54|0.19|<0.0001
71900374|NCT02064439|143322831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.8172|TWO_SIDED|95.0|0.57|2.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.||2.06|0.57|0.8172
71900375|NCT02064439|143322832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.3318|TWO_SIDED|95.0|0.69|3.02||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.02|0.69|0.3318
71900376|NCT02064439|143322832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9726|TWO_SIDED|95.0|0.44|2.2||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||2.20|0.44|0.9726
71900377|NCT02064439|143322832|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.3137|TWO_SIDED|95.0|0.7|3.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||||3.06|0.70|0.3137
71900378|NCT02262039|143322871|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71900379|NCT02262039|143322872|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
71900380|NCT02262039|143322873|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
71900381|NCT02262039|143322874|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
71900382|NCT02262039|143322875|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71900383|NCT02262039|143322876|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||||||0.82
71900384|NCT02262039|143322877|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||||||0.45
71900385|NCT04174638|143322878|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05. The p value was the value of the total score of the Fluid Control in Hemodialysis Patients Scale.|t-test, 2 sided|||||||<0.001
71900386|NCT04174638|143322879|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||||||<0.001
71900387|NCT04174638|143322880|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the knowledge sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
71900388|NCT04174638|143322880|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the motivation sub-dimension score of Modified Morisky Scale between intervention and control group from baseline to week 12.||||<0.001
71900389|NCT04174638|143322884|SUPERIORITY|||||||0.297||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the physical functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.297
71900390|NCT04174638|143322884|SUPERIORITY|||||||0.742||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the mental functions sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.742
71900391|NCT04174638|143322884|SUPERIORITY|||||||0.719||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the burden of kidney disease sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.719
71900392|NCT04174638|143322884|SUPERIORITY|||||||0.063||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||It was calculated for detect of difference in mean the symptoms/problems sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||0.063
71900393|NCT04174638|143322884|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05.|t-test, 2 sided|||It was calculated for detect of difference in mean the effects of kidney disease on daily life sub-dimension score of Kidney Disease Quality of Life Instrument 36 Scale between intervention and control group from baseline to week 12.||||<0.001
71900394|NCT00321984|143322889|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71900395|NCT00321984|143322889|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71900396|NCT00321984|143322889|SUPERIORITY_OR_OTHER|||||||0.72941||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.72941
71849773|NCT00696241|143213233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.712|TWO_SIDED|95.0|-1.74|1.19||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.19|-1.74|0.712
71849774|NCT00696241|143213233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.818|TWO_SIDED|95.0|-1.63|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-1.63|0.818
71849775|NCT00696241|143213234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.35|||<|0.001|TWO_SIDED|95.0|-14.05|-8.64||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.64|-14.05|<0.001
71849776|NCT00696241|143213234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|||<|0.001|TWO_SIDED|95.0|-15.38|-9.98||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.98|-15.38|<0.001
71849777|NCT00696241|143213234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.81|||<|0.001|TWO_SIDED|95.0|-16.51|-11.11||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-11.11|-16.51|<0.001
71849778|NCT00696241|143213234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.75|TWO_SIDED|95.0|-1.83|2.54||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||2.54|-1.83|0.750
71849779|NCT00696241|143213234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.378|TWO_SIDED|95.0|-3.16|1.2||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.20|-3.16|0.378
71849780|NCT00696241|143213234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.059|TWO_SIDED|95.0|-4.28|0.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.08|-4.28|0.059
71849781|NCT00696241|143213235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.25|||<|0.001|TWO_SIDED|95.0|-9.02|-5.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.48|-9.02|<0.001
71849782|NCT00696241|143213235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.16|||<|0.001|TWO_SIDED|95.0|-9.92|-6.4||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.40|-9.92|<0.001
71849783|NCT00696241|143213235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.41|||<|0.001|TWO_SIDED|95.0|-10.17|-6.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-6.65|-10.17|<0.001
71849784|NCT00696241|143213235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.845|TWO_SIDED|95.0|-1.29|1.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.57|-1.29|0.845
71849785|NCT00696241|143213235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.29|TWO_SIDED|95.0|-2.19|0.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.65|-2.19|0.290
71849786|NCT00696241|143213235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.161|TWO_SIDED|95.0|-2.44|0.41||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.41|-2.44|0.161
71900397|NCT00321984|143322891|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71900398|NCT00321984|143322891|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71900399|NCT00321984|143322891|SUPERIORITY_OR_OTHER|||||||0.3146||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.31460
71900400|NCT02985450|143322912|OTHER||Mean Difference (Final Values)|513.5|STANDARD_DEVIATION|73.6||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||Anti-HBs levels difference: high risk obesity group - low risk obesity group NAFLD patients|||||0.02
71849787|NCT00696241|143213236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.94|||<|0.001|TWO_SIDED|95.0|-13.88|-8.0||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.00|-13.88|<0.001
71849788|NCT00696241|143213236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.18|||<|0.001|TWO_SIDED|95.0|-14.11|-8.24||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-8.24|-14.11|<0.001
71849789|NCT00696241|143213236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.21|||<|0.001|TWO_SIDED|95.0|-15.15|-9.28||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-9.28|-15.15|<0.001
71849790|NCT00696241|143213236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.385|TWO_SIDED|95.0|-3.43|1.33||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.33|-3.43|0.385
71849791|NCT00696241|143213236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.285|TWO_SIDED|95.0|-3.66|1.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.08|-3.66|0.285
71849792|NCT00696241|143213236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33||||0.054|TWO_SIDED|95.0|-4.7|0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.04|-4.70|0.054
71900401|NCT00431847|143322922|SUPERIORITY_OR_OTHER||Slope|-0.0323|STANDARD_ERROR_OF_MEAN|0.00619|<|0.0001|TWO_SIDED|95.0|-0.0448|-0.02013|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02013|-0.0448|<0.0001
71900402|NCT00431847|143322922|SUPERIORITY_OR_OTHER||Chi Squared|2.65||||0.4492|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4492
71900403|NCT00431847|143322922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.108|STANDARD_ERROR_OF_MEAN|0.2308||0.64|TWO_SIDED|95.0|-0.5621|0.3461|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.|Estimated intercept group difference|A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3461|-0.5621|0.640
71900404|NCT00431847|143322922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3299|STANDARD_ERROR_OF_MEAN|0.3372||0.3286|TWO_SIDED|95.0|-0.3334|0.9932|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9932|-0.3334|0.3286
71900405|NCT00431847|143322922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8591|STANDARD_ERROR_OF_MEAN|0.4716||0.0694|TWO_SIDED|95.0|-0.06841|1.7866|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.7866|-0.06841|0.0694
71900406|NCT00431847|143322923|SUPERIORITY_OR_OTHER||Slope|-0.02332|STANDARD_ERROR_OF_MEAN|0.003777|<|0.0001|TWO_SIDED|95.0|-0.03076|-0.01589|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01589|-0.03076|<0.0001
71900407|NCT00431847|143322923|SUPERIORITY_OR_OTHER||Chi-Squared|2.49||||0.4772|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4772
71900408|NCT00431847|143322923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07724|STANDARD_ERROR_OF_MEAN|0.1503||0.6077|TWO_SIDED|95.0|-0.2184|0.3729|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3729|-0.2184|0.6077
71900409|NCT00431847|143322923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2004|STANDARD_ERROR_OF_MEAN|0.2194||0.3616|TWO_SIDED|95.0|-0.2311|0.6319|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.6319|-0.2311|0.3616
71900410|NCT00431847|143322923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3082|STANDARD_ERROR_OF_MEAN|0.3066||0.3155|TWO_SIDED|95.0|-0.2948|0.9112|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.9112|-0.2948|0.3155
71900411|NCT00431847|143322924|SUPERIORITY_OR_OTHER||Slope|-0.02746|STANDARD_ERROR_OF_MEAN|0.004202|<|0.0001|TWO_SIDED|95.0|-0.03573|-0.01919|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01919|-0.03573|<0.0001
71900412|NCT00431847|143322924|SUPERIORITY_OR_OTHER||Chi-Squared|3.4||||0.3345|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3345
71900413|NCT00431847|143322924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0386|STANDARD_ERROR_OF_MEAN|0.1718||0.8223|TWO_SIDED|95.0|-0.2993|0.3765|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3765|-0.2993|0.8223
71900414|NCT00431847|143322924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2919|STANDARD_ERROR_OF_MEAN|0.2506||0.2448|TWO_SIDED|95.0|-0.2009|0.7848|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.7848|-0.2009|0.2448
71900415|NCT00431847|143322924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4482|STANDARD_ERROR_OF_MEAN|0.3502||0.2014|TWO_SIDED|95.0|-0.2405|1.1369|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1369|-0.2405|0.2014
71849793|NCT00696241|143213237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|||<|0.001|TWO_SIDED|95.0|-8.93|-4.75||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.75|-8.93|<0.001
71849794|NCT00696241|143213237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.001|TWO_SIDED|95.0|-8.89|-4.72||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.72|-8.89|<0.001
71849795|NCT00696241|143213237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-9.64|-5.47||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-5.47|-9.64|<0.001
71849796|NCT00696241|143213237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.642|TWO_SIDED|95.0|-2.09|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.29|-2.09|0.642
71849797|NCT00696241|143213237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.672|TWO_SIDED|95.0|-2.05|1.32||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||1.32|-2.05|0.672
71849798|NCT00696241|143213237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.196|TWO_SIDED|95.0|-2.8|0.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||0.57|-2.80|0.196
71849799|NCT00696241|143213238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48|||<|0.001|TWO_SIDED|95.0|2.71|7.39||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.39|2.71|<0.001
71849800|NCT00696241|143213238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.97|||<|0.001|TWO_SIDED|95.0|3.01|8.2||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.20|3.01|<0.001
71849801|NCT00696241|143213238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.53|||<|0.001|TWO_SIDED|95.0|3.95|10.79||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||10.79|3.95|<0.001
71900416|NCT00431847|143322925|SUPERIORITY_OR_OTHER||Slope|-0.0403|STANDARD_ERROR_OF_MEAN|0.007196|<|0.0001|TWO_SIDED|95.0|-0.5446|-0.02613|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.02613|-0.5446|<0.0001
71900417|NCT00431847|143322925|SUPERIORITY_OR_OTHER||Chi-Squared|3.19||||0.3631|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3631
71900418|NCT00431847|143322925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1004|STANDARD_ERROR_OF_MEAN|0.2746||0.7148|TWO_SIDED|95.0|-0.6404|0.4396|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.4396|-0.6404|0.7148
71817910|NCT01108510|143138733|SUPERIORITY_OR_OTHER||Difference in least squares mean (LSM)|-5.0||||0.67|TWO_SIDED|95.0|-28.0|18.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||18|-28|0.67
71817911|NCT01108510|143138734|SUPERIORITY_OR_OTHER||Difference in LSM|-10.0||||0.51|TWO_SIDED|95.0|-38.0|19.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||19|-38|0.51
71817912|NCT01108510|143138735|SUPERIORITY_OR_OTHER||Difference in LSM|-22.0||||0.18|TWO_SIDED|95.0|-54.0|10.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||10|-54|0.18
71817913|NCT01108510|143138736|SUPERIORITY_OR_OTHER||Difference in LSM|6.0||||0.84|TWO_SIDED|95.0|-55.0|67.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.|||67|-55|0.84
71817914|NCT01003639|143138788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.05|TWO_SIDED|95.0|0.0|1.43|||ANCOVA|||||1.43|0|0.05
71817915|NCT04362137|143138794|SUPERIORITY||Odds Ratio (OR)|0.91||||0.769|TWO_SIDED|95.0|0.48|1.73|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||1.73|0.48|0.769
71849802|NCT00696241|143213238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.173|TWO_SIDED|95.0|0.57|1.11||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.11|0.57|0.173
71849803|NCT00696241|143213238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.449|TWO_SIDED|95.0|0.63|1.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.23|0.63|0.449
71849804|NCT00696241|143213238|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.402|TWO_SIDED|95.0|0.83|1.62||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.62|0.83|0.402
71849805|NCT00696241|143213239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.86|||<|0.001|TWO_SIDED|95.0|1.82|4.48||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.48|1.82|<0.001
71817916|NCT04362137|143138796|SUPERIORITY||Odds Ratio (OR)|0.89||||0.647|TWO_SIDED|95.0|0.55|1.46|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.46|0.55|0.647
71817917|NCT04362137|143138796|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.52|1.92|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.92|0.52|0.997
71817918|NCT04362137|143138797|SUPERIORITY||Odds Ratio (OR)|0.98||||0.946|TWO_SIDED|95.0|0.51|1.87|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.87|0.51|0.946
71817919|NCT04362137|143138797|SUPERIORITY||Odds Ratio (OR)|0.79||||0.573|TWO_SIDED|95.0|0.35|1.79|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||1.79|0.35|0.573
71817920|NCT04362137|143138798|SUPERIORITY||Odds Ratio (OR)|0.75||||0.532|TWO_SIDED|95.0|0.31|1.83|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||1.83|0.31|0.532
71817921|NCT04362137|143138798|SUPERIORITY||Odds Ratio (OR)|1.18||||0.764|TWO_SIDED|95.0|0.4|3.49|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||3.49|0.40|0.764
71817922|NCT04362137|143138799|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.33|TWO_SIDED|95.0|0.9|1.37|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.37|0.90|0.330
71817923|NCT04362137|143138800|SUPERIORITY||Least squares (LS) mean|-0.03|STANDARD_ERROR_OF_MEAN|0.144||0.831|TWO_SIDED|95.0|-0.31|0.25|||ANCOVA|||Day 15||0.25|-0.31|0.831
71817924|NCT04362137|143138800|SUPERIORITY||LS Mean|0.08|STANDARD_ERROR_OF_MEAN|0.155||0.624|TWO_SIDED|95.0|-0.23|0.38|||ANCOVA|||Day 29||0.38|-0.23|0.624
71900419|NCT00431847|143322925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3568|STANDARD_ERROR_OF_MEAN|0.4009||0.3741|TWO_SIDED|95.0|-0.4318|1.1453|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.1453|-0.4318|0.3741
71900420|NCT00431847|143322925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2969|STANDARD_ERROR_OF_MEAN|0.5609||0.0213|TWO_SIDED|95.0|0.1938|2.4|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.4000|0.1938|0.0213
71900421|NCT00431847|143322926|SUPERIORITY_OR_OTHER||Slope|-0.02776|STANDARD_ERROR_OF_MEAN|0.004706|<|0.0001|TWO_SIDED|95.0|-0.03702|-0.0185|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.01850|-0.03702|<0.0001
71900422|NCT00431847|143322926|SUPERIORITY_OR_OTHER||Chi-Squared|3.88||||0.2752|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.2752
71900423|NCT00431847|143322926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3079|STANDARD_ERROR_OF_MEAN|0.1918||0.1094|TWO_SIDED|95.0|-0.6851|0.06941|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.06941|-0.6851|0.1094
71900424|NCT00431847|143322926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0428|STANDARD_ERROR_OF_MEAN|0.28||0.8786|TWO_SIDED|95.0|-0.5079|0.5935|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5935|-0.5079|0.8786
71900425|NCT00431847|143322926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6759|STANDARD_ERROR_OF_MEAN|0.391||0.0847|TWO_SIDED|95.0|-0.09297|1.4448|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.4448|-0.09297|0.0847
71900426|NCT00431847|143322927|SUPERIORITY_OR_OTHER||Slope|-0.03645|STANDARD_ERROR_OF_MEAN|0.005913|<|0.0001|TWO_SIDED|95.0|-0.04808|-0.02481|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.02481|-0.04808|<0.0001
71900427|NCT00431847|143322927|SUPERIORITY_OR_OTHER||Chi-Squared|3.16||||0.3677|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3677
71900428|NCT00431847|143322927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05816|STANDARD_ERROR_OF_MEAN|0.221||0.7926|TWO_SIDED|95.0|-0.4929|0.3766|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.3766|-0.4929|0.7926
71900429|NCT00431847|143322927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1708|STANDARD_ERROR_OF_MEAN|0.3212||0.5953|TWO_SIDED|95.0|-0.461|0.8026|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.8026|-0.4610|0.5953
71900430|NCT00431847|143322927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6873|STANDARD_ERROR_OF_MEAN|0.4482||0.1261|TWO_SIDED|95.0|-0.1943|1.5689|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5689|-0.1943|0.1261
71900431|NCT00431847|143322928|SUPERIORITY_OR_OTHER||Slope|-0.4831|STANDARD_ERROR_OF_MEAN|0.1243||0.0002|TWO_SIDED|95.0|-0.7286|-0.2377|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.2377|-0.7286|0.0002
71817925|NCT04362137|143138801|SUPERIORITY||Odds Ratio (OR)|0.94||||0.944|TWO_SIDED|95.0|0.2|5.57|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 15||5.57|0.20|0.944
71817926|NCT04362137|143138801|SUPERIORITY||Odds Ratio (OR)|1.21||||0.775|TWO_SIDED|95.0|0.35|5.11|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|Day 29||5.11|0.35|0.775
71817927|NCT04362137|143138802|SUPERIORITY||Odds Ratio (OR)|0.99||||0.987|TWO_SIDED|95.0|0.45|2.21|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \< 1 favors the ruxolitinib 5 mg arm|||2.21|0.45|0.987
71849806|NCT00696241|143213239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39|||<|0.001|TWO_SIDED|95.0|2.15|5.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.35|2.15|<0.001
71849807|NCT00696241|143213239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.41|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||6.02|2.41|<0.001
71849808|NCT00696241|143213239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.52|1.13||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.52|0.177
71849809|NCT00696241|143213239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.61|1.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.35|0.61|0.628
71849810|NCT00696241|143213239|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.928|TWO_SIDED|95.0|0.68|1.52||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.52|0.68|0.928
71849811|NCT00696241|143213240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.53|||<|0.001|TWO_SIDED|95.0|2.66|7.72||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||7.72|2.66|<0.001
71849812|NCT00696241|143213240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.04|||<|0.001|TWO_SIDED|95.0|2.96|8.58||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||8.58|2.96|<0.001
71849813|NCT00696241|143213240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.75|||<|0.001|TWO_SIDED|95.0|3.96|11.48||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||11.48|3.96|<0.001
71849814|NCT00696241|143213240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.217|TWO_SIDED|95.0|0.58|1.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.13|0.58|0.217
71849815|NCT00696241|143213240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.537|TWO_SIDED|95.0|0.64|1.26||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.26|0.64|0.537
71849816|NCT00696241|143213240|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.276|TWO_SIDED|95.0|0.86|1.68||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||1.68|0.86|0.276
71849817|NCT01742832|143213241|OTHER|Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.||||||0.342||||||P-value for linear regression assessing outcome measure (MADRS score) and treatment group.|Regression, Linear|||||||0.342
71849818|NCT03060525|143213271|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|1.51||0.026|TWO_SIDED|95.0|-6.32|-0.41|||Mixed Models Analysis|||Difference in weight change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.41|-6.32|0.026
71849819|NCT03060525|143213272|SUPERIORITY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.59||0.03|TWO_SIDED|95.0|-2.42|-0.12|||Mixed Models Analysis|||Difference in Body Mass Index (BMI) change from Baseline to 6months, between Immediate Intervention participants (group and videophone combined) vs. Delayed Intervention participants (group and videophone combined). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||-0.12|-2.42|0.03
71817928|NCT04362137|143138803|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.738|TWO_SIDED|95.0|0.84|1.28|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.28|0.84|0.738
71817929|NCT04362137|143138804|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.869|TWO_SIDED|95.0|0.84|1.23|||Proportional hazards model||Between group comparison using competing risk framework. A hazard ratio \> 1 favors the ruxolitinib 5 mg arm|||1.23|0.84|0.869
71817930|NCT04362137|143138807|SUPERIORITY||Odds Ratio (OR)|0.61||||0.325|TWO_SIDED|95.0|0.23|1.63|||Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 15||1.63|0.23|0.325
71817931|NCT04362137|143138807|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.25|5.4||P-value was not estimable because \>97% patients fall into one category (responders) in both groups, and very few patients fall into the other one (non-responders), which made the logistic regression model fail to converge even with Firth's correction|Regression, Logistic||Comparison is ruxolitinib 5 mg/placebo. An odds ratio \> 1 favors the ruxolitinib 5 mg arm|Day 29||5.40|0.25|
71817932|NCT01234649|143138829|SUPERIORITY||||||<|0.04|||||||ANOVA|||Factorial repeated measures design||||<0.04
71817933|NCT01234649|143138830|SUPERIORITY||||||<|0.005|||||||ANOVA|||Factorial repeated measures ANOVA||||<.005
71817934|NCT01234649|143138831|SUPERIORITY||||||<|0.011|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.011
71817935|NCT01234649|143138832|SUPERIORITY||||||>|0.05|||||||ANOVA|||Nested repeated measures design||||>0.05
71817936|NCT01234649|143138833|SUPERIORITY||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.03
71817937|NCT01234649|143138834|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817938|NCT01234649|143138835|SUPERIORITY||||||<|0.048|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.048
71817939|NCT01234649|143138836|SUPERIORITY||||||<|0.04|||||||ANOVA|||||||<0.04
71817940|NCT01234649|143138837|SUPERIORITY||||||<|0.047|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.047
71900432|NCT00431847|143322928|SUPERIORITY_OR_OTHER||Chi-Squared|3.2||||0.3617|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.3617
71679499|NCT01500213|142877042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.084|TWO_SIDED|95.0|1.0|1.9||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.9|1.0|0.084
71817941|NCT01234649|143138838|SUPERIORITY||||||<|0.023|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.023
71817942|NCT01234649|143138839|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817943|NCT01234649|143138840|SUPERIORITY|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA||||0.042
71817944|NCT01234649|143138841|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817945|NCT01234649|143138842|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817946|NCT01234649|143138843|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817947|NCT01234649|143138844|SUPERIORITY||||||<|0.046|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.046
71817948|NCT01234649|143138845|SUPERIORITY||||||<|0.049|||||||ANOVA|||Factorial repeated measures ANOVA||||<0.049
71817949|NCT01234649|143138846|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817950|NCT01234649|143138847|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817951|NCT01234649|143138848|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817952|NCT01234649|143138849|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817953|NCT01234649|143138850|SUPERIORITY||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA||||>0.05
71817954|NCT00318149|143138855|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS25 Group) was smaller than (\<) 2.0.|Geometric mean ratio|0.9|||||TWO_SIDED|98.75|0.7|1.16||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.16|0.7|
71817955|NCT00318149|143138855|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS50 Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.05|||||TWO_SIDED|98.75|0.71|1.56||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.56|0.71|
71817956|NCT00318149|143138855|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01B Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.04|||||TWO_SIDED|98.75|0.79|1.38||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.38|0.79|
71817957|NCT00318149|143138855|NON_INFERIORITY|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01E Group) was smaller than (\<) 2.0.|Geometric mean ratio|1.07|||||TWO_SIDED|98.75|0.79|1.44||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.||1.44|0.79|
71817958|NCT01304082|143138868|SUPERIORITY_OR_OTHER|||||||0.7535||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||0.7535
71817959|NCT01304082|143138869|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
71679500|NCT03197870|142877046|SUPERIORITY|The primary hypotheses was tested in the modified intent-to-treat population using a Fisher's Exact Test with a 2-sided 5% significance level. razuprotafib 15 mg twice daily was tested first. If this was found to be statistically significant, then razuprotafib 15 mg once daily will be tested for statistical significance, at the same significance level.||||||0.495||||||Missing data was imputed using last observation carried forward; baseline values were not carried forward.|Fisher Exact|||The primary hypotheses tested was that razuprotafib 15 mg twice daily and razuprotafib 15 mg once daily will be superior to placebo in the improvement of diabetic retinopathy as measured by the Early Treatment Diabetic Retinopathy Study severity scale change from baseline at 48 weeks.||||0.495
71817960|NCT01304082|143138870|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
71817961|NCT01304082|143138871|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"||||<0.0001
71817962|NCT02262260|143138874|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in BCVA at month 12 from the baseline visit were determined for both treatment groups, and a comparison was made between the two groups using the Independent Samples t-test."||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71817963|NCT02262260|143138875|NON_INFERIORITY|"In order to demonstrate that the wait and extend regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in Central Retinal Thickness determined with Optical Coherence Tomography for both eyes were calculated for both groups and were compared using the Mann Whitney u test."||||||0.082|||||||Wilcoxon (Mann-Whitney)|||||||0.082
71817964|NCT02262260|143138878|NON_INFERIORITY|Comparison was made between the two groups using the Independent Samples t-test.||||||0.095|||||||Chi-squared|||||||0.095
71817965|NCT02262260|143138879|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test.||||||0.072|||||||Chi-squared|||||||0.072
71900433|NCT00431847|143322928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1574|STANDARD_ERROR_OF_MEAN|2.7573||0.2532|TWO_SIDED|95.0|-2.2715|8.5863|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||8.5863|-2.2715|0.2532
71900434|NCT00431847|143322928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2227|STANDARD_ERROR_OF_MEAN|3.9633||0.758|TWO_SIDED|95.0|-6.5833|9.0286|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||9.0286|-6.5833|0.7580
71900435|NCT00431847|143322928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.1649|STANDARD_ERROR_OF_MEAN|5.3759||0.1837|TWO_SIDED|95.0|-17.7484|3.4187|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.4187|-17.7484|0.1837
71900436|NCT00431847|143322929|SUPERIORITY_OR_OTHER||Slope|0.4741|STANDARD_ERROR_OF_MEAN|0.03909|<|0.0001|TWO_SIDED|95.0|0.3971|0.5511|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.5511|0.3971|<0.0001
71688683|NCT02634983|142892845|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|90.0|0.26|0.38|||t-test, 2 sided|||FEV1 Day 8 (2 hrs post-dose)||0.38|0.26|<0.0001
71817966|NCT02262260|143138880|NON_INFERIORITY|comparison was made between the two groups using the Independent Samples t-test||||||0.466|||||||Chi-squared|||||||0.466
71817967|NCT01794117|143138889|SUPERIORITY|||||||0.033|||||||Wilcoxon Signed Rank Test|||||||0.033
71817968|NCT02322814|143138890|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.247||95.0|0.43|1.24|||Log Rank|||||1.24|0.43|0.2470
71817969|NCT02322814|143138892|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5912||95.0|0.65|2.13|||Log Rank|||||2.13|0.65|0.5912
71817970|NCT02459093|143138918|SUPERIORITY||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.37|0.99|||Chi-squared|||||0.99|0.37|0.04
71817971|NCT02459093|143138919|SUPERIORITY||Risk Ratio (RR)|0.6||||0.05|TWO_SIDED|95.0|0.36|1.01|||Chi-squared|||||1.01|0.36|0.05
71817972|NCT01744860|143138969|SUPERIORITY_OR_OTHER||Kappa coefficient|0.8611|||||TWO_SIDED|95.0|0.8125|0.9097||||||"Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory in-house methods and Cobas 4800 Mutation Test."||0.9097|0.8125|
71817973|NCT01567865|143139003|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|1.84|||||TWO_SIDED|95.0|-5.97|9.66||||||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||9.66|-5.97|
71849820|NCT03060525|143213273|SUPERIORITY||Median Difference (Net)|247.5||||0.63|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change in amount of physical activity = 6-month MET-minutes/week - baseline MET-minutes/week (change from pre to post intervention), using the International Physical Activity Questionnaire. IPAQ score is a continuous measure and reports median MET-minutes per week (a combination of walking met-minutes/week + moderate activity MET-minutes/week + vigorous activity MET-minutes/week). \[analysis of 2 arms, immediate intervention vs. delayed intervention\]||||0.63
71849821|NCT00090519|143213274|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.969|TWO_SIDED|95.0|-0.714|0.686|||ANOVA|||||0.686|-0.714|0.969
71849822|NCT00090519|143213275|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.015|TWO_SIDED|95.0|0.21|1.97||P-value is for change from baseline.|ANCOVA|||||1.97|0.21|0.015
71849823|NCT00090519|143213276|SUPERIORITY_OR_OTHER|||||||0.577||95.0||||P-value is for first occurrence of focal/grid photocoagulation yes versus no.|Chi-squared|||||||0.577
71849824|NCT00090519|143213277|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.041|TWO_SIDED|95.0|0.02|0.87||P-value is for change from baseline.|ANCOVA|||||0.87|0.02|0.041
71849825|NCT00090519|143213278|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression.|Chi-squared|||||||0.475
71849826|NCT00090519|143213279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.211|TWO_SIDED|95.0|-0.87|3.92||P-value is for change from baseline.|ANCOVA|||||3.92|-0.87|0.211
71849827|NCT00090519|143213280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.22||||0.365|TWO_SIDED|95.0|-73.68|200.12||P-value is for change from baseline.|t-test, 2 sided|||||200.12|-73.68|0.365
71849828|NCT00090519|143213281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.52||||0.009|TWO_SIDED|95.0|0.38|2.66||P-value is for change from baseline.|ANCOVA|||||2.66|0.38|0.009
71849829|NCT00090519|143213283|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.081|TWO_SIDED|95.0|0.2|1.12||P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no.|Chi-squared|||||1.12|0.20|0.081
71849830|NCT01974102|143213284|SUPERIORITY||||||<|0.015|||||||t-test, 2 sided|||||||<0.015
71849831|NCT01974102|143213285|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
71849832|NCT01294644|143213336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.52|4.43|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||4.43|1.52|<0.001
71900437|NCT00431847|143322929|SUPERIORITY_OR_OTHER||Chi-Squared|1.83||||0.6075|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6075
71900438|NCT00431847|143322929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9534|STANDARD_ERROR_OF_MEAN|1.2763||0.4558|TWO_SIDED|95.0|-3.4675|1.5607|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.5607|-3.4675|0.4558
71900439|NCT00431847|143322929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3505|STANDARD_ERROR_OF_MEAN|1.977||0.0914|TWO_SIDED|95.0|-7.2442|0.5432|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||0.5432|-7.2442|0.0914
71900440|NCT00431847|143322929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.37|STANDARD_ERROR_OF_MEAN|3.0921||0.007|TWO_SIDED|95.0|-14.4589|-2.281|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-2.2810|-14.4589|0.007
71900441|NCT00431847|143322930|SUPERIORITY_OR_OTHER||Slope|-0.2169|STANDARD_ERROR_OF_MEAN|0.04148|<|0.0001|TWO_SIDED|95.0|-0.2987|-0.1352|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1352|-0.2987|<0.0001
71900442|NCT00431847|143322930|SUPERIORITY_OR_OTHER||Chi-Squared|6.37||||0.095|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0950
71900443|NCT00431847|143322930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7246|STANDARD_ERROR_OF_MEAN|1.3351||0.5878|TWO_SIDED|95.0|-1.9056|3.3547|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3547|-1.9056|0.5878
71688684|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|90.0|0.15|0.33|||t-test, 2 sided|||FVC Day 1 (0.25 hrs post-dose)||0.33|0.15|<0.0001
71817974|NCT01567865|143139003|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-2.48|||<|0.05|TWO_SIDED|95.0|-9.92|4.98|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||4.98|-9.92|<0.05
71817975|NCT01567865|143139003|EQUIVALENCE|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-4.33|||<|0.05|TWO_SIDED|95.0|-11.94|3.31|||t-test, 2 sided|||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."||3.31|-11.94|<0.05
71817976|NCT01567865|143139003|NON_INFERIORITY|The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.|Mean Difference (Net)|-4.03|||<|0.05|TWO_SIDED|95.0|-9.74|3.1|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%."||3.1|-9.74|<0.05
71817977|NCT00309608|143139034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.95|-0.39||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 10 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.39|-0.95|<0.0001
71817978|NCT00309608|143139034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.01|-0.44||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.44|-1.01|<0.0001
71817979|NCT00309608|143139034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0055||95.0|-0.68|-0.12||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"||-0.12|-0.68|0.0055
71849833|NCT01294644|143213336|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.13|||<|0.001|TWO_SIDED|95.0|1.83|5.36|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||5.36|1.83|<0.001
71688685|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 1 (1 hrs post-dose)||0.45|0.25|<0.0001
71849834|NCT01294644|143213337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.02|TWO_SIDED|95.0|1.48|92.67|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||92.67|1.48|0.020
71849835|NCT01294644|143213337|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.53||||0.021|TWO_SIDED|95.0|1.46|91.24|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios \>1 indicate a positive treatment effect.|||91.24|1.46|0.021
71849836|NCT01294644|143213338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.37|||<|0.001|TWO_SIDED|95.0|3.06|9.44|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model.|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||9.44|3.06|<0.001
71688686|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|90.0|0.2|0.42|||t-test, 2 sided|||FVC Day 1 (2 hrs post-dose)||0.42|0.20|<0.0001
71817980|NCT00309608|143139034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.99|-0.46|||Pairwise comparison based on ANCOVA|||"Placebo vs. Linagliptin 10 mg~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)."||-0.46|-0.99|<0.0001
71817981|NCT00309608|143139034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-1.02|-0.48|||Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.48|-1.02|<0.0001
71817982|NCT00309608|143139034|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.14||0.0049||95.0|-0.66|-0.12|||Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using last observation carried forward (LOCF)."||-0.12|-0.66|0.0049
71817983|NCT00309608|143139035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|18.575||||0.0054|TWO_SIDED|95.0|2.367|145.781|||Regression, Logistic|||Linagliptin 10 mg vs. Placebo||145.781|2.367|0.0054
71817984|NCT00309608|143139035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.715||||0.0214|TWO_SIDED|95.0|1.439|95.351|||Regression, Logistic|||Linagliptin 5 mg vs. Placebo||95.351|1.439|0.0214
71817985|NCT00309608|143139035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.776||||0.0167|TWO_SIDED|95.0|1.586|102.895|||Regression, Logistic|||Linagliptin 1 mg vs. Placebo||102.895|1.586|0.0167
71817986|NCT00309608|143139035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|31.36||||0.001|TWO_SIDED|95.0|4.063|242.028|||Regression, Logistic|||Glimepiride vs. Placebo||242.028|4.063|0.0010
71817987|NCT00309608|143139036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.5|STANDARD_ERROR_OF_MEAN|6.07|<|0.0001||95.0|-41.4|-17.5|||Pairwise comparison based on ANCOVA|||Linagliptin 10mg vs. Placebo||-17.5|-41.4|<0.0001
71817988|NCT00309608|143139036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-34.92|STANDARD_ERROR_OF_MEAN|6.16|<|0.0001||95.0|-47.0|-22.8|||Pairwise comparison based on ANCOVA|||Linagliptin 5mg vs. Placebo||-22.8|-47.0|<0.0001
71817989|NCT00309608|143139036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.95|STANDARD_ERROR_OF_MEAN|6.13||0.0022||95.0|-31.0|-6.87|||Pairwise comparison based on ANCOVA|||Linagliptin 1 mg vs. Placebo||-6.87|-31.0|0.0022
71849837|NCT01294644|143213338|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.62|||<|0.001|TWO_SIDED|95.0|2.65|8.04|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios \>1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."||8.04|2.65|<0.001
71849838|NCT01294644|143213339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|||<|0.001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline CR-SMFRS values as covariate.||||-0.19|-0.51|<0.001
71849839|NCT01294644|143213339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||<|0.001|TWO_SIDED|95.0|-0.56|-0.24|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit\*treatment interaction, and the baseline CR-SMFRS values as covariate.||||-0.24|-0.56|<0.001
71849840|NCT01294644|143213340|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|||<|0.001|TWO_SIDED|95.0|0.97|1.75|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.75|0.97|<0.001
71849841|NCT01294644|143213340|SUPERIORITY_OR_OTHER||LS Mean Difference|1.26|||<|0.001|TWO_SIDED|95.0|0.87|1.65|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.||||1.65|0.87|<0.001
71849842|NCT01294644|143213341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.09|TWO_SIDED|95.0|-1.72|0.13|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||0.13|-1.72|0.090
71849843|NCT01294644|143213341|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.97||||0.04|TWO_SIDED|95.0|-1.89|-0.05|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit\*treatment interaction, and the Baseline values as covariate.||||-0.05|-1.89|0.040
71849844|NCT01294644|143213342|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Pearson's chi-square test|||||||0.009
71849845|NCT01294644|143213342|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Pearson's chi-square test|||||||0.001
71849846|NCT02548585|143213354|SUPERIORITY||||||<|0.0001|||||||ANCOVA|p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.||||||< 0.0001
71849847|NCT02548585|143213355|SUPERIORITY|||||||0.0008|||||||ANCOVA|p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.||||||0.0008
71849848|NCT01782209|143213385|OTHER||Incidence|17.3|||||TWO_SIDED|95.0|13.4|21.8|||||95% Clopper-Pearson Confidence Interval|||21.8|13.4|
71849849|NCT02033174|143213394|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.05
71849850|NCT03242863|143213395|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71849851|NCT03242863|143213396|SUPERIORITY|||||||0.0015|||||||Mixed Models Analysis|||||||0.0015
71849852|NCT03242863|143213397|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71817990|NCT02906683|143139043|SUPERIORITY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|6.8||0.329|TWO_SIDED|95.0|-20.1|6.7|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.7|-20.1|0.329
71817991|NCT02906683|143139043|SUPERIORITY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.84||0.285|TWO_SIDED|95.0|-20.9|6.2|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||6.2|-20.9|0.285
71849853|NCT03242863|143213398|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71849854|NCT01079949|143213406|SUPERIORITY_OR_OTHER|||||||0.5739||95.0|||||Wilcoxon two sample test|||||||0.5739
71849855|NCT01079949|143213411|SUPERIORITY_OR_OTHER|||||||0.1734||95.0|||||Wilcoxon two sample test|||||||0.1734
71849856|NCT01079949|143213412|SUPERIORITY_OR_OTHER|||||||0.0642||95.0|||||Wilcoxon two sample test|||||||0.0642
71849857|NCT01079949|143213416|SUPERIORITY_OR_OTHER|||||||0.408||95.0|||||Wilcoxon two sample test|||||||0.4080
71849858|NCT01079949|143213419|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Wilcoxon two sample test|||||||0.0648
71849859|NCT01079949|143213420|SUPERIORITY_OR_OTHER|||||||0.6799||95.0|||||ANOVA|||||||0.6799
71849860|NCT01079949|143213421|SUPERIORITY_OR_OTHER|||||||0.0634||95.0|||||Wilcoxon two sample test|||||||0.0634
71849861|NCT01079949|143213423|SUPERIORITY_OR_OTHER|||||||0.0166||95.0|||||Wilcoxon two sample test|||||||0.0166
71849862|NCT01079949|143213424|SUPERIORITY_OR_OTHER|||||||0.8812||95.0|||||ANOVA|||||||0.8812
71900444|NCT00431847|143322930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2466|STANDARD_ERROR_OF_MEAN|2.0697||0.9053|TWO_SIDED|95.0|-4.3231|3.8299|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.8299|-4.3231|0.9053
71849863|NCT02144285|143213428|SUPERIORITY_OR_OTHER||Absolute Bioavailability|0.45|||||TWO_SIDED|90.0|0.34|0.6||||||||0.60|0.34|
71849864|NCT04919499|143213443|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0252|STANDARD_ERROR_OF_MEAN|0.0376|||TWO_SIDED|95.0|-0.1048|0.0545|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0545|-0.1048|
71849865|NCT04919499|143213444|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|-0.0101|STANDARD_ERROR_OF_MEAN|0.0236|||TWO_SIDED|95.0|-0.0625|0.0422|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0422|-0.0625|
71849866|NCT04919499|143213445|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.0016|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.0504|0.0536|||||Calculated as \[high-dose BI 765128\] - \[Sham\]|||0.0536|-0.0504|
71849867|NCT04919499|143213446|OTHER|A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.|Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-4.7|5.0|||||"Calculated as \[high-dose BI 765128\] - \[Sham\]~Results were rounded to one decimal place."|||5.0|-4.7|
71849868|NCT03786471|143213454|SUPERIORITY||marginal difference of LS means|0.3||||0.33|TWO_SIDED|97.5|-0.18|0.78||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.78|-0.18|0.33
71849869|NCT03786471|143213454|SUPERIORITY||marginal difference of LS means|-0.62||||0.33|TWO_SIDED|97.5|-1.61|0.37||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.37|-1.61|0.33
71849870|NCT03786471|143213454|SUPERIORITY||marginal difference of LS means|-0.33||||0.46|TWO_SIDED|97.5|-1.32|0.67||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.67|-1.32|0.46
71849871|NCT03786471|143213461|SUPERIORITY||marginal difference of LS means|0.25||||0.54|TWO_SIDED|97.5|-0.16|0.66||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.66|-0.16|0.54
71849872|NCT03786471|143213461|SUPERIORITY||marginal difference of LS means|-0.1||||0.79|TWO_SIDED|97.5|-0.94|0.74||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.74|-0.94|0.79
71849873|NCT03786471|143213461|SUPERIORITY||marginal difference of LS means|0.14||||0.79|TWO_SIDED|97.5|-0.7|0.99||Alpha = 0.025; Hochberg correction for three pairwise comparisons|Mixed Models Analysis|||||0.99|-0.70|0.79
71849874|NCT03786471|143213468|SUPERIORITY||marginal difference of LS means|0.52||||0.48|TWO_SIDED|95.0|-0.09|1.13||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.13|-.09|0.48
71849875|NCT03786471|143213468|SUPERIORITY||marginal difference of LS means|-0.81||||0.62|TWO_SIDED|95.0|-2.07|0.45||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||0.45|-2.07|0.62
71849876|NCT03786471|143213468|SUPERIORITY||marginal difference of LS means|-1.33||||0.23|TWO_SIDED|95.0|-2.58|-0.07||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||-0.07|-2.58|0.23
71817992|NCT02906683|143139045|SUPERIORITY||Mean Difference (Final Values)|-11.3|STANDARD_ERROR_OF_MEAN|6.48||0.082|TWO_SIDED|95.0|-24.1|1.5|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||1.5|-24.1|0.082
71817993|NCT02906683|143139045|SUPERIORITY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.34||0.057|TWO_SIDED|95.0|-24.7|0.4|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||0.4|-24.7|0.057
71817994|NCT02906683|143139047|SUPERIORITY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|7.38||0.019|TWO_SIDED|95.0|-32.2|-3.0|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-3.0|-32.2|0.019
71849877|NCT03786471|143213475|SUPERIORITY||marginal difference of LS means|0.28||||0.23|TWO_SIDED|95.0|0.01|0.54||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||.54|.01|0.23
71900445|NCT00431847|143322930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3457|STANDARD_ERROR_OF_MEAN|3.2285||0.4682|TWO_SIDED|95.0|-8.7034|4.012|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.0120|-8.7034|0.4682
71817995|NCT02906683|143139047|SUPERIORITY||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|7.36||0.023|TWO_SIDED|95.0|-31.5|-2.3|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 4||-2.3|-31.5|0.023
71817996|NCT02906683|143139049|SUPERIORITY||Mean Difference (Final Values)|-11.4|STANDARD_ERROR_OF_MEAN|7.36||0.125|TWO_SIDED|95.0|-25.9|3.2|||t-test, 2 sided|||TAS-303 3 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||3.2|-25.9|0.125
71817997|NCT02906683|143139049|SUPERIORITY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|7.8||0.221|TWO_SIDED|95.0|-25.1|5.9|||t-test, 2 sided|||TAS-303 6 mg group vs. Placebo group for the mean percentage changes in IEF per 24 hours from baseline to Week 8||5.9|-25.1|0.221
71817998|NCT00999661|143139092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.8|STANDARD_DEVIATION|25.12|<|0.0001||95.0|36.6|43.1||One-sample t-test for change from baseline|t-test, 2 sided|||||43.1|36.6|<0.0001
71817999|NCT00999661|143139093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.6|STANDARD_DEVIATION|19.79|<|0.0001||95.0|34.0|39.2|||t-test, 2 sided|||||39.2|34.0|<0.0001
71818000|NCT00999661|143139094|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|STANDARD_DEVIATION|5.233|<|0.0001||95.0|-8.65|-7.29|||t-test, 2 sided|||||-7.29|-8.65|<0.0001
71818001|NCT01421589|143139167|SUPERIORITY_OR_OTHER|||||||0.02|||||||Regression, Linear|||Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.||||0.02
71818002|NCT01421589|143139168|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71818003|NCT01421589|143139169|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71849878|NCT03786471|143213475|SUPERIORITY||marginal difference of LS means|0.01||||0.98|TWO_SIDED|95.0|-0.53|0.55||Alpha = 0.05; Hochberg correction for three pairwise comparisons \*three secondary outcomes|Mixed Models Analysis|||||.55|-.53|.98
71849879|NCT03786471|143213475|SUPERIORITY||marginal difference of LS means|-0.27||||0.65|TWO_SIDED|95.0|-0.81|0.27||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.27|-0.81|0.65
71849880|NCT03786471|143213480|SUPERIORITY||marginal difference of LS means|-0.16||||0.62|TWO_SIDED|95.0|-0.37|0.06||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||0.06|-0.37|0.62
71849881|NCT03786471|143213480|SUPERIORITY||marginal difference of LS means|0.7||||0.01|TWO_SIDED|95.0|0.26|1.14||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.14|0.26|0.01
71849882|NCT03786471|143213480|SUPERIORITY||marginal difference of LS means|0.85||||0.001|TWO_SIDED|95.0|0.42|1.29||Alpha = 0.05; Hochberg correction for three pairwise comparisons \* three secondary outcomes|Mixed Models Analysis|||||1.29|0.42|0.001
71849883|NCT03346200|143213503|NON_INFERIORITY|The non-inferiority margin was based on the proportion of responders and was set to 17%. That is, we defined non-inferiority to mean that the proportion of responders in the non-referent study arms is not less than one third of the responders in the 20 mg group (50% minus 33% = 17%)|Median Difference (Final Values)|52.5|||<|0.01|TWO_SIDED|97.5|41.9|100.0|||one-sided Wald tests|P-values were corrected for multiple comparisons using the Holm-Bonferroni method. Non-inferiority p-values were declared if less than a=0.025||||100|41.9|<0.01
71849884|NCT01416285|143213544|SUPERIORITY|||||||0.004|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||All-cause death||||0.004
71849885|NCT01416285|143213544|SUPERIORITY|||||||0.003|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||Heart failure-related re-hospitalizations||||0.003
71849886|NCT01416285|143213544|SUPERIORITY||||||<|0.001|||||||Kaplan-Meier and COX regression|Univariate and multi-variable||a composite outcome of both death and heart failure-related re-hospitalizations||||<0.001
71849887|NCT02935673|143213554|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.32|||||TWO_SIDED|95.0|-0.89|0.24|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.24|-0.89|
71849888|NCT02935673|143213554|SUPERIORITY||AUC(1-7) difference vs (pooled) placebo|-0.36|||||TWO_SIDED|95.0|-1.33|0.62|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.|0.62|-1.33|
71849889|NCT02410278|143213687|SUPERIORITY||Odds Ratio (OR)|3.931||||0.0617|TWO_SIDED|95.0|0.938|20.832|||weighted logistic regression model|||Odds ratio is the odds of an event in the Montelukast treatment group divided by the odds of an event in the placebo treatment group. P-value is from the likelihood ratio test that the odds ratio is 1. CI = profile likelihood confidence interval.||20.832|0.938|0.0617
71818004|NCT01421589|143139170|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71818005|NCT01421589|143139171|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71818006|NCT01421589|143139172|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71818007|NCT01421589|143139173|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71818008|NCT02694640|143139193|SUPERIORITY|The study was powered to detect significant between-group differences in mean min/week MVPA at follow-up.|effect size|0.11|||<|0.05|TWO_SIDED|||||No adjustment for multiple comparisons was made|Regression, Linear||Effect size refers to between-group difference at follow-up.|A series of longitudinal mixed effects models with subject-specific intercepts were used to examine between-group differences in mean min/week of self reported moderate-to-vigorous physical activity (MVPA).||||<.05
71818009|NCT02694640|143139194|SUPERIORITY||effect size|0.09|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
71849890|NCT02410278|143213688|SUPERIORITY||adjusted mean difference|0.084||||0.3753|TWO_SIDED|95.0|-0.104|0.273|||ANCOVA|||Results are obtained from an ANCOVA model for comparing average change of the GSRS score in the two treatment groups, adjusted for age, weight and baseline GSRS score. Weights, defined as the proportions of days with GSRS score recorded during the Day 1 - Day 10 period are applied to adjust for missing data.||0.273|-0.104|0.3753
71849891|NCT02410278|143213689|SUPERIORITY||adjusted mean difference|0.081||||0.0376|TWO_SIDED|95.0|0.005|0.158|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Week 10.||0.158|0.005|0.0376
71849892|NCT02410278|143213690|SUPERIORITY||Hazard Ratio (HR)|1.094||||0.7952|TWO_SIDED|95.0|0.554|2.164|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||2.164|0.554|0.7952
71900446|NCT00431847|143322931|SUPERIORITY_OR_OTHER||Slope|0.04639|STANDARD_ERROR_OF_MEAN|0.03562||0.1938|TWO_SIDED|95.0|-0.02369|0.1165|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1165|-0.02369|0.1938
71900447|NCT00431847|143322931|SUPERIORITY_OR_OTHER||Chi-Squared|2.43||||0.4884|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4884
71818010|NCT05462652|143139207|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|-3.68|-1.59|||Mixed Models Analysis|||||-1.59|-3.68|<0.001
71818011|NCT05462652|143139208|SUPERIORITY||Difference in proportion z-test|20.1|||<|0.001|TWO_SIDED|95.0|9.1|31.0|||Chi-squared|||"Missing values imputed with multiple imputation.~P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test."||31.0|9.1|<0.001
71818012|NCT05462652|143139209|SUPERIORITY||Difference in proportions z-test|15.4||||0.003|TWO_SIDED|95.0|5.3|25.6|||Chi-squared|||P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||25.6|5.3|0.003
71818013|NCT05462652|143139210|SUPERIORITY||Difference in proportion z-test|24.7|||<|0.001|TWO_SIDED|95.0|13.0|36.4|||Chi-squared|||Missing values imputed with multiple imputation. P-values are obtained from a Pearson Chi-Squared test; differences and 95% CIs are obtained from a difference in proportions Z- test.||36.4|13.0|<0.001
71818014|NCT00759772|143139212|SUPERIORITY||||||<|0.01||||||Calculated p-value.|t-test, 2 sided|||||||< 0.01
71818015|NCT04548531|143139270|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.001|TWO_SIDED|95.0|0.41|0.94|||t-test, 2 sided|||||0.94|0.41|<.001
71818016|NCT04548531|143139271|SUPERIORITY||Risk Difference (RD)|21.0||||0.003|TWO_SIDED|95.0|7.0|35.0|||Chi-squared|||||35|7|0.003
71818017|NCT04548531|143139272|SUPERIORITY||Risk Difference (RD)|3.0||||0.75|TWO_SIDED|95.0|-10.0|16.0|||Chi-squared|||We tested for a clear preference for screening, if a patient chose a colonoscopy or a stool-based test vs. the other response options.||16|-10|.75
71818018|NCT04548531|143139273|SUPERIORITY||Risk Difference (RD)|11.0||||0.14|TWO_SIDED|95.0|-3.0|26.0|||Chi-squared|||We categorized for likelihood to follow through with screening. We reported on results from patients who indicated 'Very Likely' on their response option vs. the other options (likely, unsure, unlikely, very unlikely)||26|-3|0.14
71818019|NCT04548531|143139274|SUPERIORITY||Risk Difference (RD)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|18.0|||Chi-squared|||Assessed how many patients completed any colorectal cancer screening test within 6-months after randomization.||18|6|<.001
71818020|NCT00737061|143139279|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.9|100.0||||||1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||100|97.9|
71900448|NCT00431847|143322931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6174|STANDARD_ERROR_OF_MEAN|1.3991||0.6593|TWO_SIDED|95.0|-2.1348|3.3696|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.3696|-2.1348|0.6593
71900449|NCT00431847|143322931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4575|STANDARD_ERROR_OF_MEAN|2.0263||0.0889|TWO_SIDED|95.0|-0.528|7.4431|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.4431|-0.5280|0.0889
71900450|NCT00431847|143322931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4499|STANDARD_ERROR_OF_MEAN|2.8061||0.8727|TWO_SIDED|95.0|-5.9692|5.0694|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||5.0694|-5.9692|0.8727
71900451|NCT00431847|143322932|SUPERIORITY_OR_OTHER||Slope|-0.523|STANDARD_ERROR_OF_MEAN|0.08855|<|0.0001|TWO_SIDED|95.0|-0.6973|-0.3486|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.3486|-0.6973|<.0001
71818021|NCT00737061|143139279|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.9||||||95.0|97.6|99.5||||||2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).||99.5|97.6|
71900452|NCT00431847|143322932|SUPERIORITY_OR_OTHER||Chi-Squared|4.89||||0.18|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.1800
71818022|NCT00737061|143139289|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|97.2|100.0||||No statistical hypothesis testing was performed.||"1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||100|97.2|
71818023|NCT00737061|143139289|SUPERIORITY_OR_OTHER||Pregnancy Prevention Rate|98.4||||||95.0|96.9|99.1||||No statistical hypothesis testing was performed.||"2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."||99.1|96.9|
71818024|NCT01844115|143139307|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.0048|TWO_SIDED|95.0|-3.72|-0.68|||MMRM|||||-0.68|-3.72|0.0048
71818025|NCT01844115|143139308|SUPERIORITY||Least Squares Mean Difference|-1.89||||0.0236|TWO_SIDED|95.0|-3.52|-0.26|||MMRM|||||-0.26|-3.52|0.0236
71818026|NCT01613027|143139321|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 6||||<0.001
71818027|NCT01613027|143139321|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||Difference in change at Month 12||||<0.001
71818028|NCT01751113|143139404|SUPERIORITY_OR_OTHER||AUC ratio|1.158|||<|0.001|TWO_SIDED|95.0|1.1|1.219|||Mixed Models Analysis|||||1.219|1.100|<0.001
71818029|NCT01751113|143139404|SUPERIORITY_OR_OTHER||AUC ratio|1.288|||<|0.001|TWO_SIDED|95.0|1.224|1.355|||Mixed Models Analysis|||||1.355|1.224|<0.001
71818030|NCT01751113|143139405|SUPERIORITY_OR_OTHER||AUC ratio|0.856|||<|0.001|TWO_SIDED|95.0|0.812|0.902|||Mixed Models Analysis|||||0.902|0.812|<0.001
71818031|NCT01751113|143139405|SUPERIORITY_OR_OTHER||AUC ratio|0.774|||<|0.001|TWO_SIDED|95.0|0.735|0.816|||Mixed Models Analysis|||||0.816|0.735|<0.001
71818032|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.181|||<|0.001|TWO_SIDED|95.0|1.104|1.263|||Mixed Models Analysis||Statistical data for 30 minutes|||1.263|1.104|<0.001
71818033|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.303|||<|0.001|TWO_SIDED|95.0|1.219|1.393|||Mixed Models Analysis||Statistical data for 30 minutes|||1.393|1.219|<0.001
71818034|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.175|||<|0.001|TWO_SIDED|95.0|1.099|1.257|||Mixed Models Analysis||Statistical data for 75 minutes|||1.257|1.099|<0.001
71818035|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.34|||<|0.001|TWO_SIDED|95.0|1.253|1.432|||Mixed Models Analysis||Statistical data for 75 minutes|||1.432|1.253|<0.001
71818036|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.151|||<|0.001|TWO_SIDED|95.0|1.076|1.231|||Mixed Models Analysis||Statistical data for 120 minutes|||1.231|1.076|<0.001
71818037|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.301|||<|0.001|TWO_SIDED|95.0|1.217|1.391|||Mixed Models Analysis||Statistical data for 120 minutes|||1.391|1.217|<0.001
71818038|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.141|||<|0.001|TWO_SIDED|95.0|1.067|1.22|||Mixed Models Analysis||Statistical data for 240 minutes|||1.220|1.067|<0.001
71818039|NCT01751113|143139406|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.239|||<|0.001|TWO_SIDED|95.0|1.159|1.325|||Mixed Models Analysis||Statistical data for 240 minutes|||1.325|1.159|<0.001
71818040|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.846|||<|0.001|TWO_SIDED|95.0|0.792|0.905|||Mixed Models Analysis||Statistical data for 30 minutes|||0.905|0.792|<0.001
71818041|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.767|||<|0.001|TWO_SIDED|95.0|0.717|0.819|||Mixed Models Analysis||Statistical data for 30 minutes|||0.819|0.717|<0.001
71818042|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.795|0.909|||Mixed Models Analysis||Statistical data for 75 minutes|||0.909|0.795|<0.001
71818043|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.746|||<|0.001|TWO_SIDED|95.0|0.698|0.798|||Mixed Models Analysis||Statistical data for 75 minutes|||0.798|0.698|<0.001
71849893|NCT02410278|143213691|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.8328|TWO_SIDED|95.0|0.563|1.589|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.||1.589|0.563|0.8328
71849894|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.115||||0.1743|TWO_SIDED|95.0|-0.052|0.283|||Repeated measures model|||Change from Day 1 to Week 1: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.283|-0.052|0.1743
71849895|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.079||||0.2677|TWO_SIDED|95.0|-0.063|0.221|||Repeated measures model|||Change from Day 1 to Week 2: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.221|-0.063|0.2677
71849896|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.085||||0.1788|TWO_SIDED|95.0|-0.04|0.211|||Repeated measures model|||Change from Day 1 to Week 3: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.211|-0.040|0.1788
71849897|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.1||||0.0866|TWO_SIDED|95.0|-0.015|0.216|||Repeated measures model|||Change from Day 1 to Week 4: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.216|-0.015|0.0866
71849898|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.1||||0.0509|TWO_SIDED|95.0|0.0|0.201|||Repeated measures model|||Change from Day 1 to Week 5: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.201|-0.000|0.0509
71818044|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.868|||<|0.001|TWO_SIDED|95.0|0.812|0.928|||Mixed Models Analysis||Statistical data for 120 minutes|||0.928|0.812|<0.001
71818045|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.769|||<|0.001|TWO_SIDED|95.0|0.719|0.822|||Mixed Models Analysis||Statistical data for 120 minutes|||0.822|0.719|<0.001
71818046|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.877|||<|0.001|TWO_SIDED|95.0|0.82|0.938|||Mixed Models Analysis||Statistical data for 240 minutes|||0.938|0.820|<0.001
71818047|NCT01751113|143139407|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.809|||<|0.001|TWO_SIDED|95.0|0.757|0.865|||Mixed Models Analysis||Statistical data for 240 minutes|||0.865|0.757|<0.001
71818048|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.157|||<|0.001|TWO_SIDED|95.0|0.116|0.198|||Mixed Models Analysis||Statistical data for FEV1|||0.198|0.116|<0.001
71818049|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.118|||<|0.001|TWO_SIDED|95.0|0.077|0.159|||Mixed Models Analysis||Statistical data for FEV1|||0.159|0.077|<0.001
71818050|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.082||||0.002|TWO_SIDED|95.0|0.031|0.133|||Mixed Models Analysis||Statistical data for FVC|||0.133|0.031|0.002
71818051|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.135|||<|0.001|TWO_SIDED|95.0|0.084|0.186|||Mixed Models Analysis||Statistical data for FVC|||0.186|0.084|<0.001
71818052|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of IC|0.054||||0.035|TWO_SIDED|95.0|0.004|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|0.004|0.035
71818053|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of IC|0.064||||0.011|TWO_SIDED|95.0|0.015|0.114|||Mixed Models Analysis||Statistical data for IC|||0.114|0.015|0.011
71818054|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.107||||0.009|TWO_SIDED|95.0|-0.187|-0.028|||Mixed Models Analysis||Statistical data for RV|||-0.028|-0.187|0.009
71818055|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.102||||0.012|TWO_SIDED|95.0|-0.18|-0.023|||Mixed Models Analysis||Statistical data for RV|||-0.023|-0.180|0.012
71818056|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.013||||0.632|TWO_SIDED|95.0|-0.066|0.04|||Mixed Models Analysis||Statistical data for TLC|||0.040|-0.066|0.632
71849899|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.088||||0.0649|TWO_SIDED|95.0|-0.006|0.182|||Repeated measures model|||Change from Day 1 to Week 6: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.182|-0.006|0.0649
71849900|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.088||||0.0479|TWO_SIDED|95.0|0.001|0.176|||Repeated measures model|||Change from Day 1 to Week 7: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.176|0.001|0.0479
71818057|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.014||||0.596|TWO_SIDED|95.0|-0.067|0.038|||Mixed Models Analysis||Statistical data for TLC|||0.038|-0.067|0.596
71818058|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.065||||0.028|TWO_SIDED|95.0|-0.123|-0.007|||Mixed Models Analysis||Statistical data for TGV|||-0.007|-0.123|0.028
71818059|NCT01751113|143139408|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.075||||0.01|TWO_SIDED|95.0|-0.133|-0.018|||Mixed Models Analysis||Statistical data for TGV|||-0.018|-0.133|0.010
71818060|NCT01751113|143139409|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.032|||<|0.001|TWO_SIDED|95.0|0.023|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.023|<0.001
71818061|NCT01751113|143139409|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.017|||<|0.001|TWO_SIDED|95.0|0.008|0.026|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.026|0.008|<0.001
71818062|NCT01751113|143139410|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.835|||<|0.001|TWO_SIDED|95.0|0.77|0.905|||Mixed Models Analysis|||||0.905|0.770|<0.001
71818063|NCT01751113|143139410|SUPERIORITY_OR_OTHER||specific airway conductance ratio|0.803|||<|0.001|TWO_SIDED|95.0|0.741|0.869|||Mixed Models Analysis|||||0.869|0.741|<0.001
71818064|NCT01751113|143139411|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.108|1.301|||Mixed Models Analysis|||||1.301|1.108|<0.001
71818065|NCT01751113|143139411|SUPERIORITY_OR_OTHER||specific airway conductance ratio|1.249|||<|0.001|TWO_SIDED|95.0|1.153|1.352|||Mixed Models Analysis|||||1.352|1.153|<0.001
71818066|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.161|||<|0.001|TWO_SIDED|95.0|0.086|0.236|||Mixed Models Analysis||Statistical data for FEV1|||0.236|0.086|<0.001
71818067|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of FEV1|0.103||||0.008|TWO_SIDED|95.0|0.028|0.178|||Mixed Models Analysis||Statistical data for FEV1|||0.178|0.028|0.008
71818068|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.104||||0.051|TWO_SIDED|95.0|0.0|0.209|||Mixed Models Analysis||Statistical data for FVC|||0.209|0.000|0.051
71818069|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of FVC|0.148||||0.006|TWO_SIDED|95.0|0.043|0.253|||Mixed Models Analysis||Statistical data for FVC|||0.253|0.043|0.006
71818070|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.12|0.104|||Mixed Models Analysis||Statistical data for IC|||0.104|-0.120|0.890
71818071|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of IC|-0.008||||0.89|TWO_SIDED|95.0|-0.118|0.103|||Mixed Models Analysis||Statistical data for IC|||0.103|-0.118|0.890
71818072|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.229|||<|0.001|TWO_SIDED|95.0|-0.355|-0.103|||Mixed Models Analysis||Statistical data for RV|||-0.103|-0.355|<0.001
71818073|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of RV|-0.189||||0.003|TWO_SIDED|95.0|-0.314|-0.064|||Mixed Models Analysis||Statistical data for RV|||-0.064|-0.314|0.003
71818074|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.101||||0.055|TWO_SIDED|95.0|-0.204|0.002|||Mixed Models Analysis||Statistical data for TLC|||0.002|-0.204|0.055
71818075|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of TLC|-0.105||||0.044|TWO_SIDED|95.0|-0.206|-0.003|||Mixed Models Analysis||Statistical data for TLC|||-0.003|-0.206|0.044
71818076|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.092||||0.085|TWO_SIDED|95.0|-0.197|0.013|||Mixed Models Analysis||Statistical data for TGV|||0.013|-0.197|0.085
71818077|NCT01751113|143139412|SUPERIORITY_OR_OTHER||Mean difference of TGV|-0.091||||0.083|TWO_SIDED|95.0|-0.195|0.012|||Mixed Models Analysis||Statistical data for TGV|||0.012|-0.195|0.083
71818078|NCT01751113|143139413|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.027|||<|0.001|TWO_SIDED|95.0|0.014|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.041|0.014|<0.001
71818079|NCT01751113|143139413|SUPERIORITY_OR_OTHER||FEV1/FVC ratio|0.008||||0.223|TWO_SIDED|95.0|-0.005|0.021|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio|||0.021|-0.005|0.223
71818080|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.23|2.69||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||2.69|-1.23|
71818081|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-1.32|2.29||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||2.29|-1.32|
71849901|NCT02410278|143213692|SUPERIORITY||adjusted mean difference|0.082||||0.054|TWO_SIDED|95.0|-0.001|0.166|||Repeated measures model|||Change from Day 1 to Week 8: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.||0.166|-0.001|0.0540
71849902|NCT02410278|143213693|SUPERIORITY||adjusted mean difference|0.129||||0.2469|TWO_SIDED|95.0|-0.092|0.349|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight (kg) and baseline GSRS score, and has unstructured variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Day 3.||0.349|-0.092|0.2469
71818082|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.76|2.08||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.08|-1.76|
71818083|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.09|2.35||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.35|-1.09|
71818084|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.88|2.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.25|-1.88|
71818085|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.47|2.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||2.37|-1.47|
71818086|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.99|1.92||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||1.92|-1.99|
71818087|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|2.39|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|0.35|4.43||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||4.43|0.35|
71818088|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.57|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||2.12|-1.57|
71818089|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-1.15|3.37||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||3.37|-1.15|
71900453|NCT00431847|143322932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.302|STANDARD_ERROR_OF_MEAN|2.8198||0.4151|TWO_SIDED|95.0|-3.253|7.857|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.8570|-3.2530|0.4151
71900454|NCT00431847|143322932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3376|STANDARD_ERROR_OF_MEAN|4.314||0.3157|TWO_SIDED|95.0|-4.1592|12.8344|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.8344|-4.1592|0.3157
71900455|NCT00431847|143322932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.825|STANDARD_ERROR_OF_MEAN|6.9715||0.0911|TWO_SIDED|95.0|-1.904|25.5541|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||25.5541|-1.9040|0.0911
71900456|NCT00431847|143322933|SUPERIORITY_OR_OTHER||Slope|-0.2888|STANDARD_ERROR_OF_MEAN|0.09078||0.0016|TWO_SIDED|95.0|-0.4675|-0.11|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1100|-0.4675|0.0016
71900457|NCT00431847|143322933|SUPERIORITY_OR_OTHER||Chi-Squared|6.33||||0.0966|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.0966
71900458|NCT00431847|143322933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9879|STANDARD_ERROR_OF_MEAN|2.4264||0.2195|TWO_SIDED|95.0|-1.7938|7.7697|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.7697|-1.7938|0.2195
71900459|NCT00431847|143322933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4636|STANDARD_ERROR_OF_MEAN|3.7381||0.5105|TWO_SIDED|95.0|-9.8289|4.9018|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.9018|-9.8289|0.5105
71818090|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-1.52|2.14||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.14|-1.52|
71818091|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|4.81|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|2.84|6.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 5 min||6.78|2.84|
71818092|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|0.12|3.73||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 10 min||3.73|0.12|
71818093|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.71|2.12||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 20 min||2.12|-1.71|
71818094|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.29|2.15||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 30 min||2.15|-1.29|
71818095|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-1.6|2.53||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1 hour||2.53|-1.60|
71818096|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.11|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-3.03|0.81||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 1.5 hours||0.81|-3.03|
71818097|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-3.13|0.78||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 2 hours||0.78|-3.13|
71818098|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|-3.36|0.71||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 3 hours||0.71|-3.36|
71818099|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-2.69|1.0||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 4 hours||1.00|-2.69|
71849903|NCT02410278|143213694|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0000
71849904|NCT02410278|143213695|SUPERIORITY|||||||1|||||||Fisher's Exact|||||||1.0000
71849905|NCT02410278|143213696|SUPERIORITY|||||||0.2604|||||||Chi-squared|||||||0.2604
71849906|NCT02584257|143213703|SUPERIORITY||Least Square Means Differences|3.171|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|2.732|3.61||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||3.610|2.732|<0.0001
71818100|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.94|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-4.19|0.32||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 8 hours||0.32|-4.19|
71818101|NCT03657264|143139426|NON_INFERIORITY|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|-1.62|2.04||p-value is not shown, as this is a non-inferiority study.|ANCOVA|Each timepoint was tested through a separate model.||For the timepoint 24 hours||2.04|-1.62|
71818102|NCT03657264|143139427|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|1.23|||TWO_SIDED|90.0|2.58|6.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1 hour||6.66|2.58|
71818103|NCT03657264|143139427|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|9.4|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|7.14|11.66||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 1.5 hours||11.66|7.14|
71818104|NCT03657264|143139427|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.55|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|7.92|13.17||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 2 hours||13.17|7.92|
71818105|NCT03657264|143139427|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.33|STANDARD_ERROR_OF_MEAN|1.22|||TWO_SIDED|90.0|7.7|12.95||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 3 hours||12.95|7.70|
71818106|NCT03657264|143139427|SUPERIORITY|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.65|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|8.05|13.25||p-value is not shown, as this is a non-inferiority study.|ANCOVA|As multiple timepoints were examined separately, the overall type I error rate needed to be adjusted.||For the timepoint 4 hours||13.25|8.05|
71818107|NCT03745794|143139512|OTHER|||||||0.17|||||||Chi-squared|||||||0.17
71818108|NCT02340520|143139537|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71818109|NCT02340520|143139538|OTHER||||||>|0.1|||||||ANOVA|||||||>0.1
71818110|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.27||||0.087|TWO_SIDED|95.0|-0.58|0.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.||||0.04|-0.58|0.087
71818111|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.84|||<|0.001|TWO_SIDED|95.0|-1.15|-0.52||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.52|-1.15|<0.001
71818112|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.014|TWO_SIDED|95.0|-0.69|-0.08||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.08|-0.69|0.014
71849907|NCT02584257|143213703|SUPERIORITY||Least Square Means Differences|3.824|STANDARD_ERROR_OF_MEAN|0.238|<|0.0001|TWO_SIDED|95.0|3.384|4.263||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.263|3.384|<0.0001
71818113|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.68|||<|0.001|TWO_SIDED|95.0|-0.99|-0.37||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.99|<0.001
71818114|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.93||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.93|-1.55|<0.001
71849908|NCT02584257|143213703|SUPERIORITY||Least Square Means Differences|3.32|STANDARD_ERROR_OF_MEAN|0.241|<|0.0001|TWO_SIDED|95.0|2.876|3.764||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL.||||3.764|2.876|<0.0001
71818115|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.97|||<|0.001|TWO_SIDED|95.0|-1.28|-0.66||Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.66|-1.28|<0.001
71818116|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.08|||<|0.001|TWO_SIDED|95.0|-1.39|-0.78||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.78|-1.39|<0.001
71900460|NCT00431847|143322933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3871|STANDARD_ERROR_OF_MEAN|6.1087||0.0903|TWO_SIDED|95.0|-22.4174|1.6433|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||1.6433|-22.4174|0.0903
71900461|NCT00431847|143322934|SUPERIORITY_OR_OTHER||Slope|-0.04113|STANDARD_ERROR_OF_MEAN|-0.04113||0.6602|TWO_SIDED|95.0|-0.2252|0.1429|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.1429|-0.2252|0.6602
71900462|NCT00431847|143322934|SUPERIORITY_OR_OTHER||Chi-Squared|1.53||||0.6764|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6764
71900463|NCT00431847|143322934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4902|STANDARD_ERROR_OF_MEAN|2.6357||0.3458|TWO_SIDED|95.0|-2.7036|7.684|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||7.6840|-2.7036|0.3458
71900464|NCT00431847|143322934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.2518|STANDARD_ERROR_OF_MEAN|4.0583||0.1969|TWO_SIDED|95.0|-13.2466|2.743|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.7430|-13.2466|0.1969
71900465|NCT00431847|143322934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.9796|STANDARD_ERROR_OF_MEAN|6.5287||0.048|TWO_SIDED|95.0|-25.8429|-0.1162|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||-0.1162|-25.8429|0.0480
71900466|NCT00431847|143322935|SUPERIORITY_OR_OTHER||Slope|-0.2349|STANDARD_ERROR_OF_MEAN|0.1003||0.0199|TWO_SIDED|95.0|-0.4323|-0.03745|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.03745|-0.4323|0.0199
71900467|NCT00431847|143322935|SUPERIORITY_OR_OTHER||Chi-Squared|2.6||||0.4577|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4577
71900468|NCT00431847|143322935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9502|STANDARD_ERROR_OF_MEAN|2.8797||0.7417|TWO_SIDED|95.0|-6.624|4.7236|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.7236|-6.6240|0.7417
71900469|NCT00431847|143322935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.258|STANDARD_ERROR_OF_MEAN|4.4523||0.7778|TWO_SIDED|95.0|-7.5129|10.0289|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||10.0289|-7.5129|0.7778
71900470|NCT00431847|143322935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.5232|STANDARD_ERROR_OF_MEAN|7.2532||0.2411|TWO_SIDED|95.0|-5.7608|22.8073|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||22.8073|-5.7608|0.2411
71900471|NCT00431847|143322936|SUPERIORITY_OR_OTHER||Slope|0.1629|STANDARD_ERROR_OF_MEAN|0.08284||0.0504|TWO_SIDED|95.0|-0.00029|0.3261|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||0.3261|-0.00029|0.0504
71900472|NCT00431847|143322936|SUPERIORITY_OR_OTHER||Chi-Squared|1.45||||0.6942|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.6942
71900473|NCT00431847|143322936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5241|STANDARD_ERROR_OF_MEAN|2.4216||0.5297|TWO_SIDED|95.0|-3.2469|6.2951|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||6.2951|-3.2469|0.5297
71900474|NCT00431847|143322936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7679|STANDARD_ERROR_OF_MEAN|3.7464||0.3155|TWO_SIDED|95.0|-11.1478|3.612|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||3.6120|-11.1478|0.3155
71900475|NCT00431847|143322936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.7558|STANDARD_ERROR_OF_MEAN|6.092||0.1105|TWO_SIDED|95.0|-21.7515|2.2399|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||2.2399|-21.7515|0.1105
71900476|NCT00431847|143322937|SUPERIORITY_OR_OTHER||Slope|-0.2979|STANDARD_ERROR_OF_MEAN|0.07538||0.001|TWO_SIDED|95.0|-0.4465|-0.1493|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.||-0.1493|-0.4465|0.001
71900477|NCT00431847|143322937|SUPERIORITY_OR_OTHER||Chi-Squared|2.72||||0.4361|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.4361
71900478|NCT00431847|143322937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9001|STANDARD_ERROR_OF_MEAN|2.6015||0.7297|TWO_SIDED|95.0|-6.0247|4.2246|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||4.2246|-6.0247|0.7297
71818117|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.7|||<|0.001|TWO_SIDED|95.0|-1.01|-0.39||Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.39|-1.01|<0.001
71818118|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.011|TWO_SIDED|95.0|-0.71|-0.09||Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.71|0.011
71818119|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.36||||0.008|TWO_SIDED|95.0|-0.62|-0.09||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.09|-0.62|0.008
71818120|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.87|||<|0.001|TWO_SIDED|95.0|-1.13|-0.6||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.60|-1.13|<0.001
71818121|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.36||||0.007|TWO_SIDED|95.0|-0.63|-0.1||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.10|-0.63|0.007
71900479|NCT00431847|143322937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.2896|STANDARD_ERROR_OF_MEAN|4.0186||0.2868|TWO_SIDED|95.0|-3.625|12.2043|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||12.2043|-3.6250|0.2868
71900480|NCT00431847|143322937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.0118|STANDARD_ERROR_OF_MEAN|6.2663||0.1516|TWO_SIDED|95.0|-3.327|21.3505|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||21.3505|-3.3270|0.1516
71818122|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.35|-0.88|<0.001
71900481|NCT00431847|143322938|SUPERIORITY_OR_OTHER||Slope|-0.9776|STANDARD_ERROR_OF_MEAN|0.1426|<|0.0001|TWO_SIDED|95.0|-1.2584|-0.6967|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T||-0.6967|-1.2584|<0.0001
71818123|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.25|||<|0.001|TWO_SIDED|95.0|-1.52|-0.99||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.99|-1.52|<0.001
71818124|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.9|||<|0.001|TWO_SIDED|95.0|-1.16|-0.63||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.63|-1.16|<0.001
71818125|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.0|||<|0.001|TWO_SIDED|95.0|-1.26|-0.74||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.74|-1.26|<0.001
71818126|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.64|||<|0.001|TWO_SIDED|95.0|-0.9|-0.37||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.37|-0.90|<0.001
71818127|NCT01076088|143139584|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.12||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.||||-0.12|-0.65|0.004
71818128|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-18.52||||0.017|TWO_SIDED|95.0|-33.75|-3.29||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-3.29|-33.75|0.017
71818129|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-61.34|||<|0.001|TWO_SIDED|95.0|-76.61|-46.07||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-46.07|-76.61|<0.001
71818130|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-31.38|||<|0.001|TWO_SIDED|95.0|-46.49|-16.28||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-16.28|-46.49|<0.001
71818131|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-48.94|||<|0.001|TWO_SIDED|95.0|-64.21|-33.67||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-33.67|-64.21|<0.001
71818132|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-87.57|||<|0.001|TWO_SIDED|95.0|-102.87|-72.27||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-72.27|-102.87|<0.001
71818133|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-69.05|||<|0.001|TWO_SIDED|95.0|-84.41|-53.7||Pairwise comparison, metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-53.70|-84.41|<0.001
71818134|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-75.17|||<|0.001|TWO_SIDED|95.0|-90.47|-59.87||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-59.87|-90.47|<0.001
71818135|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-43.79|||<|0.001|TWO_SIDED|95.0|-58.99|-28.58||Pairwise comparison, metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-28.58|-58.99|<0.001
71818136|NCT01076088|143139585|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-26.23|||<|0.001|TWO_SIDED|95.0|-41.62|-10.84||Pairwise comparison, sitagliptin 100 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.||||-10.84|-41.62|<0.001
71818137|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.11||||0.069|TWO_SIDED|95.0|-16.86|0.64||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||0.64|-16.86|0.069
71900482|NCT00431847|143322938|SUPERIORITY_OR_OTHER||Chi-Squared|0.78||||0.8548|TWO_SIDED||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.||||0.8548
71900483|NCT00431847|143322938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3635|STANDARD_ERROR_OF_MEAN|3.8899||0.3882|TWO_SIDED|95.0|-4.3026|11.0296|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.0296|-4.3026|0.3882
71900484|NCT00431847|143322938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5029|STANDARD_ERROR_OF_MEAN|5.9044||0.9322|TWO_SIDED|95.0|-12.1376|11.1317|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||11.1317|-12.1376|0.9322
71900485|NCT00431847|143322938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.1166|STANDARD_ERROR_OF_MEAN|9.2462||0.0233|TWO_SIDED|95.0|2.8992|39.3341|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.||39.3341|2.8992|0.0233
71900486|NCT01469013|143322939|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71900487|NCT01469013|143322941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED||||||Cochran-Armitage trend test|||||||0.009
71900488|NCT03161678|143322976|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.|||||<|0.001|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||<0.001
71900489|NCT03161678|143322976|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.24|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.24
71900490|NCT03161678|143322977|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.75|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 G143E mutation. The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.75
71849909|NCT02584257|143213703|SUPERIORITY||Least Square Means Differences|3.872|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|3.43|4.315||Fixed effects of dose, week, and sequence and the random effect of the patient was carried out to ensure that the overall treatment effect was significant at p\<0.05.|Brief Mixed Models Analysis|For this model, the dependent variable was log2(PC20FEV1) values where PC20FEV1 was measured in mg/mL||||4.315|3.430|<0.0001
71679501|NCT01542034|142877067|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.702|||<|0.001|TWO_SIDED|95.0|2.808|4.88|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||4.880|2.808|<0.001
71679502|NCT01542034|142877068|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.||The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.||||<0.001
71679503|NCT01542034|142877069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|8.541|||<|0.001|TWO_SIDED|95.0|3.62|20.148|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||20.148|3.620|<0.001
71679504|NCT01542034|142877070|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was \> 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.||||<0.001
71900491|NCT03161678|143322977|OTHER|The effect of CES1 genotype on agonist-stimulated change in platelet aggregation was calculated using variance component method that simultaneously adjusted for age, sex, body mass index (BMI), and relatedness among study participants. Relatedness among participants were accounted for by including a polygenic component as a random effect. Please see the Study Protocol and Statistical Analysis Plan document for additional information.||||||0.011|||||||Regression, Linear|All analyses were adjusted for age, sex, body mass index (BMI), and relatedness among study participants.||Change in platelet aggregation was assessed between the wild-type group and the carriers of the CES1 functional mutation (rs7498748). The null hypothesis is that, following drug intervention, there is no difference in the change in platelet aggregation between genotype groups.||||0.011
71900492|NCT00739297|143322978|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.01|0.08|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.08|-0.01|
71900493|NCT00739297|143322978|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.1||||||95.0|0.04|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.04|
71900494|NCT00739297|143322978|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|0.02|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|0.02|
71900495|NCT00739297|143322978|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
71900496|NCT00739297|143322978|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.04|0.13|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.13|0.04|
71900497|NCT00739297|143322979|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.19||||||95.0|0.04|0.34|||||Repeated measures model with terms for treatment (Albuterol/Placebo), dose, treatment-by-dose interaction and baseline FEV1|||0.34|0.04|
71900498|NCT00739297|143322980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.01|0.12|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.12|-0.01|
71900499|NCT00739297|143322980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|0.0|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.00|
71900500|NCT00739297|143322980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.11|-0.01|
71900501|NCT00739297|143322980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.06||||||95.0|-0.03|0.14|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.14|-0.03|
71900502|NCT00739297|143322980|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
71900503|NCT00739297|143322981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.04||||||95.0|-0.03|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.03|
71900504|NCT00739297|143322981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.09||||||95.0|0.01|0.17|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.17|0.01|
71900505|NCT00739297|143322981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.10|-0.01|
71900506|NCT00739297|143322981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.07||||||95.0|-0.02|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|-0.02|
71900507|NCT00739297|143322981|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.|||0.15|0.01|
71900508|NCT01757704|143322984|SUPERIORITY_OR_OTHER||Median Difference (Net)|56.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71900509|NCT02749721|143322993|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71900510|NCT02749721|143322994|OTHER|||||||0.012|||||||Paired t-test|||||||0.012
71900511|NCT02749721|143322995|OTHER||Pearson's R|0.125||||0.61|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (amplitude) baseline scores||||0.610
71900512|NCT02749721|143322995|OTHER||Pearson's R|-0.294||||0.288|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (amplitude) baseline scores||||0.288
71679505|NCT02612610|142877071|OTHER||LS Mean Difference|-0.25||||0.0971|TWO_SIDED|95.0|-0.54|0.05|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.05|-0.54|0.0971
71849910|NCT02584257|143213703|EQUIVALENCE|A blinded interim analysis was performed after 60 patients completed all treatment visits which determined that 80 subjects would be sufficient to complete the study with 90% power.|Frel|1.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|0.93|1.48|||||Frel is the relative bioavailability of the test versus reference product. The CI was a bias corrected and accelerated CI based on a bootstrapping procedure. The FDA acceptable CI was between 0.67 and 1.50.|An Emax model was developed and the 90% confidence interval of Frel was a bias corrected accelerated confidence interval based on a bootstrapping procedure. The bootstrapping procedure used for this analysis was residual resampling. The Per-Protocol population was the primary population for bioequivalence analysis. Patients in the PP population must have completed at least 2 treatment periods with valid PC20FEV1 measurements and had no major protocol deviations within those intervals.||1.48|0.93|
71849911|NCT03693989|143213719|OTHER|||||||0.065|||||||t-test, 2 sided|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.065
71849912|NCT03693989|143213720|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.223|||||||t-test, 2 sided|||||||0.223
71849913|NCT03693989|143213721|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.621|||||||Chi-squared, Corrected|||||||0.621
71849914|NCT03693989|143213722|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.246|||||||Fisher Exact|||||||0.246
71849915|NCT03693989|143213723|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||||||0.497
71849916|NCT03693989|143213724|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.047|||||||t-test, 2 sided|||||||0.047
71849917|NCT03693989|143213725|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.3|||||||Chi-squared, Corrected|||||||0.300
71849918|NCT03693989|143213726|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.045|||||||t-test, 2 sided|||||||0.045
71849919|NCT03693989|143213727|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.346|||||||Fisher Exact|||burning eyes comparison||||0.346
71849920|NCT03693989|143213727|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.489|||||||Fisher Exact|||Itching eyes comparison||||0.489
71849921|NCT03693989|143213727|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||foreign body sensation eyes comparison||||0.497
71849922|NCT03693989|143213727|OTHER|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||1|||||||Fisher Exact|||blurred vision comparison||||1.000
71849923|NCT00113529|143213728|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|37.1||||||95.0|21.5|55.1|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.|||55.1|21.5|
71849924|NCT00113529|143213734|SUPERIORITY_OR_OTHER||probability|82.4||||||95.0|64.9|91.7||||||||91.7|64.9|
71849925|NCT00113529|143213743|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.075
71849926|NCT00113529|143213743|SUPERIORITY_OR_OTHER|||||||0.749||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.749
71849927|NCT00113529|143213743|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.834
71900513|NCT02749721|143322995|OTHER||Pearson's R|-0.405||||0.134|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (amplitude) baseline scores||||0.134
71900514|NCT02749721|143322995|OTHER||Pearson's R|-0.397||||0.083|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (amplitude) baseline scores||||0.083
71849928|NCT00113529|143213743|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
71849929|NCT00113529|143213743|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.332
71849930|NCT00113529|143213744|SUPERIORITY_OR_OTHER|||||||0.473||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.473
71849931|NCT00113529|143213744|SUPERIORITY_OR_OTHER|||||||0.286||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.286
71849932|NCT00113529|143213744|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.277
71849933|NCT00113529|143213744|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.956
71849934|NCT00113529|143213744|SUPERIORITY_OR_OTHER|||||||0.278||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.278
71849935|NCT00113529|143213745|SUPERIORITY_OR_OTHER|||||||0.275||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.275
71849936|NCT00113529|143213745|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.227
71849937|NCT00113529|143213745|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.029
71849938|NCT00113529|143213745|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||1.000
71849939|NCT00113529|143213745|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||1.000
71900515|NCT02749721|143322995|OTHER||Pearson's R|-0.476||||0.034|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (amplitude) baseline scores||||0.034
71849940|NCT00113529|143213746|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.435
71849941|NCT00113529|143213746|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.722
71849942|NCT00113529|143213746|SUPERIORITY_OR_OTHER|||||||0.645||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.645
71849943|NCT00113529|143213746|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.140
71849944|NCT00113529|143213746|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.046
71849945|NCT00113529|143213747|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
71849946|NCT00113529|143213747|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
71849947|NCT00113529|143213747|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
71849948|NCT00113529|143213747|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
71849949|NCT00113529|143213747|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
71849950|NCT00113529|143213747|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
71849951|NCT00113529|143213748|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
71849952|NCT00113529|143213748|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
71849953|NCT00113529|143213748|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
71900516|NCT02749721|143322995|OTHER||Pearson's R|-0.509||||0.031|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 baseline scores||||0.031
71900517|NCT02749721|143322995|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (amplitude) baseline scores||||0.500
71900518|NCT02749721|143322995|OTHER||Pearson's R|0.376||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b baseline scores||||0.185
71818138|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-25.88|||<|0.001|TWO_SIDED|95.0|-34.72|-17.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-17.04|-34.72|<0.001
71900519|NCT02749721|143322995|OTHER||Pearson's R|-0.108||||0.659|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 baseline scores||||0.659
71818139|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.72||||0.198|TWO_SIDED|95.0|-14.44|3.0||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||3.00|-14.44|0.198
71818140|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-17.53|||<|0.001|TWO_SIDED|95.0|-26.33|-8.72||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-8.72|-26.33|<0.001
71818141|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-35.81|||<|0.001|TWO_SIDED|95.0|-44.56|-27.06||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-27.06|-44.56|<0.001
71818142|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.7|||<|0.001|TWO_SIDED|95.0|-36.4|-19.0||Pairwise comparison, metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-19.00|-36.40|<0.001
71818143|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-27.45|||<|0.001|TWO_SIDED|95.0|-36.18|-18.73||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-18.73|-36.18|<0.001
71818144|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-21.73|||<|0.001|TWO_SIDED|95.0|-30.42|-13.04||Pairwise comparison, metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-13.04|-30.42|<0.001
71818145|NCT01076088|143139586|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.93||||0.027|TWO_SIDED|95.0|-18.72|-1.14||Pairwise comparison, sitagliptin 100 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.||||-1.14|-18.72|0.027
71818146|NCT04921969|143139601|SUPERIORITY||Odds Ratio (OR)|4.74||||0.0001|TWO_SIDED|95.0|1.951|13.315||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.315|1.951|0.0001
71818147|NCT04921969|143139601|SUPERIORITY||Odds Ratio (OR)|10.72|||<|0.0001|TWO_SIDED|95.0|4.429|30.042||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||30.042|4.429|<0.0001
71818148|NCT04921969|143139602|SUPERIORITY||Odds Ratio (OR)|1.41||||0.4198|TWO_SIDED|95.0|0.61|3.268||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.268|0.610|0.4198
71818149|NCT04921969|143139602|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1685|TWO_SIDED|95.0|0.779|4.174||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.174|0.779|0.1685
71818150|NCT01242176|143139613|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.67|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.1|105.37|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV).|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.37|98.10|
71849954|NCT00113529|143213748|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
71849955|NCT00113529|143213748|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
71849956|NCT00113529|143213748|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
71849957|NCT00113529|143213749|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
71849958|NCT00113529|143213749|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
71849959|NCT00113529|143213749|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
71849960|NCT00113529|143213749|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
71849961|NCT00113529|143213749|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
71849962|NCT00113529|143213749|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
71849963|NCT00113529|143213750|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
71849964|NCT00113529|143213750|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
71849965|NCT00113529|143213750|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
71849966|NCT00113529|143213750|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
71849967|NCT00113529|143213750|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
71849968|NCT00113529|143213750|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
71849969|NCT00113529|143213751|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
71849970|NCT00113529|143213751|SUPERIORITY_OR_OTHER|||||||0.854||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.854
71849971|NCT00113529|143213751|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.230
71849972|NCT00113529|143213751|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.067
71849973|NCT00113529|143213751|SUPERIORITY_OR_OTHER|||||||0.164||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.164
71849974|NCT00113529|143213751|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
71849975|NCT00113529|143213752|SUPERIORITY_OR_OTHER|||||||0.734||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.734
71849976|NCT00113529|143213752|SUPERIORITY_OR_OTHER|||||||0.462||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.462
71849977|NCT00113529|143213752|SUPERIORITY_OR_OTHER|||||||0.423||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||0.423
71849978|NCT00113529|143213752|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.510
71849979|NCT00113529|143213752|SUPERIORITY_OR_OTHER|||||||0.608||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.608
71849980|NCT00113529|143213752|SUPERIORITY_OR_OTHER|||||||0.121||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.121
71849981|NCT00113529|143213753|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.910
71849982|NCT00113529|143213753|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.020
71849983|NCT00113529|143213753|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
71849984|NCT00113529|143213753|SUPERIORITY_OR_OTHER|||||||0.509||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.509
71849985|NCT00113529|143213753|SUPERIORITY_OR_OTHER|||||||0.883||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.883
71849986|NCT00113529|143213753|SUPERIORITY_OR_OTHER|||||||0.582||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.582
71849987|NCT00113529|143213754|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1||||0.428
71849988|NCT00113529|143213754|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28||||0.075
71849989|NCT00113529|143213754|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1||||1.000
71849990|NCT00113529|143213754|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28||||0.019
71849991|NCT00113529|143213754|SUPERIORITY_OR_OTHER|||||||0.124||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1||||0.124
71849992|NCT00113529|143213754|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28||||0.055
71849993|NCT02791308|143213767|EQUIVALENCE|Proportion of Subjects with Treatment Success at Visit 4/Day 15|Other|0.407|||||TWO_SIDED|90.0|-15.57|3.53||||||Percentage of Subjects with Treatment Success at Visit 4/Day 15||3.53|-15.57|
71849994|NCT00795639|143213773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0||||0.0104|TWO_SIDED|95.0|3.0|26.0||Significance test performed using non-parametric analysis of covariance controlling for Baseline 6MWD and PAH etiology and PAH not secondary to a connective tissue disease (other).|ANCOVA||Missing value at Week 12 assigned as zero if the subject had a predefined clinical worsening event, otherwise, missing value at Week 12 imputed with the last non-missing 6MWD based on LOCF.|||26|3|0.0104
71849995|NCT00795639|143213774|SUPERIORITY_OR_OTHER|||||||0.2908|TWO_SIDED|||||Significance tests of WHO Functional Class performed using the Cochran-Mantel-Haenszel (CMH) test, stratified by Baseline 6MWD (less than 310 meters and greater than or equal to 310 meters) and PAH Etiology (Connective Tissue Disease and others).|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores, and the p-value corresponding to ANCOVA (row mean scores) statistics were used.||Week 12||||0.2908
71849996|NCT00674765|143213786|SUPERIORITY_OR_OTHER|||||||0.388|||||||t-test, 2 sided|t=.87||||||.388
71900520|NCT02749721|143322995|OTHER||Pearson's R|0.125||||0.611|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a baseline scores||||0.611
71900521|NCT02749721|143322995|OTHER||Pearson's R|-0.111||||0.671|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.671
71900522|NCT02749721|143322995|OTHER||Pearson's R|-0.026||||0.931|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.931
71900523|NCT02749721|143322995|OTHER||Pearson's R|0.516||||0.155|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MADRS (baseline to endpoint percent change)||||0.155
71818151|NCT01242176|143139614|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|99.46|STANDARD_DEVIATION|18.7|||TWO_SIDED|90.0|90.18|109.68|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||109.68|90.18|
71818152|NCT01242176|143139615|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.8|STANDARD_DEVIATION|6.7|||TWO_SIDED|90.0|98.26|105.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2||105.48|98.26|
71818153|NCT03390036|143139616|SUPERIORITY|||||||0.8106|||||||ANOVA|||||||0.8106
71818154|NCT03390036|143139617|SUPERIORITY|||||||0.3007|||||||ANOVA|||||||0.3007
71818155|NCT03390036|143139618|SUPERIORITY|||||||0.6354|||||||ANOVA|||||||0.6354
71818156|NCT03390036|143139619|SUPERIORITY|||||||0.5754|||||||ANOVA|||||||0.5754
71818157|NCT03390036|143139620|SUPERIORITY|||||||0.4759|||||||ANOVA|||||||0.4759
71849997|NCT04421456|143213787|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.75|STANDARD_ERROR_OF_MEAN|2.33||0.4528|TWO_SIDED|95.0|-6.35|2.84|||Mixed-effects repeated measures model|||||2.84|-6.35|0.4528
71849998|NCT04421456|143213787|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect. For the PANSS-T score, baseline PANSS-P, baseline PANSS-N, and baseline PANSS-G are included in the model as fixed effects for the associated baseline instead of baseline PANSS-T.|Least square mean difference|-1.96|STANDARD_ERROR_OF_MEAN|2.44||0.4226|TWO_SIDED|95.0|-6.76|2.85|||Mixed-effects repeated measures model|||||2.85|-6.76|0.4226
71849999|NCT04421456|143213788|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.83||0.4479|TWO_SIDED|95.0|-2.25|1.0|||Mixed-effects repeated measures model|||||1.00|-2.25|0.4479
71900524|NCT02749721|143322995|OTHER||Pearson's R|0.268||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MADRS (baseline to endpoint percent change)||||0.297
71900525|NCT02749721|143322995|OTHER||Pearson's R|0.184||||0.494|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MADRS (baseline to endpoint percent change)||||0.494
71900526|NCT02749721|143322995|OTHER||Pearson's R|-0.065||||0.811|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.811
71818158|NCT03390036|143139621|SUPERIORITY|||||||0.5596|||||||ANOVA|||||||0.5596
71818159|NCT03390036|143139622|SUPERIORITY|||||||0.4551|||||||ANOVA|||||||0.4551
71900527|NCT02749721|143322995|OTHER||Pearson's R|-0.048||||0.877|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.877
71900528|NCT02749721|143322995|OTHER||Pearson's R|-0.246||||0.557|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and DSST (baseline to endpoint percent change)||||0.557
71900529|NCT02749721|143322995|OTHER||Pearson's R|0.182||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and DSST (baseline to endpoint percent change)||||0.500
71900530|NCT02749721|143322995|OTHER||Pearson's R|0.288||||0.297|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and DSST (baseline to endpoint percent change)||||0.297
71900531|NCT02749721|143322995|OTHER|Differences in BNA scores between MDD and healthy subjects were analyzed for baseline visits using an ANCOVA model with group as a factor, and age as a covariate.|F statistic|0.318||||0.575|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.575
71900532|NCT02749721|143322995|OTHER||F statistic|0.378||||0.541|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.541
71900533|NCT02749721|143322995|OTHER||F|0.012||||0.912|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.912
71900534|NCT02749721|143322995|OTHER||F statistic|1.586||||0.214|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.214
71900535|NCT02749721|143322995|OTHER||F statistic|0.453||||0.504|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.504
71818160|NCT03390036|143139623|SUPERIORITY|||||||0.7931|||||||ANOVA|||||||0.7931
71818161|NCT00358215|143139624|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.871|TWO_SIDED|95.0|0.9|1.13||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none)|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.13|0.90|0.871
71818162|NCT00358215|143139625|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.512|TWO_SIDED|95.0|0.92|1.19||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.19|0.92|0.512
71818163|NCT00358215|143139626|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.922|TWO_SIDED|95.0|0.89|1.14||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.|||1.14|0.89|0.922
71818164|NCT00358215|143139627|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.79||0.005|TWO_SIDED|95.0|0.65|3.75|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||3.75|0.65|0.005
71818165|NCT00358215|143139628|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.29|STANDARD_ERROR_OF_MEAN|0.9||0.011|TWO_SIDED|95.0|0.53|4.05|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.||||4.05|0.53|0.011
71818166|NCT01169259|143139671|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.06|||Regression, Cox|||||1.06|0.88|
71818167|NCT01169259|143139671|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.93|1.13|||Regression, Cox|||||1.13|0.93|
71850000|NCT04421456|143213788|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.87||0.1616|TWO_SIDED|95.0|-2.92|0.49|||Mixed-effects repeated measures model|||||0.49|-2.92|0.1616
71850001|NCT04421456|143213789|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.76||0.6787|TWO_SIDED|95.0|-1.8|1.18|||Mixed-effects repeated measures model|||||1.18|-1.80|0.6787
71850002|NCT04421456|143213789|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.78||0.3351|TWO_SIDED|95.0|-0.79|2.3|||Mixed-effects repeated measures model|||||2.30|-0.79|0.3351
71850003|NCT04421456|143213790|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.45||0.4504|TWO_SIDED|95.0|-3.96|1.76|||Mixed-effects repeated measures model|||||1.76|-3.96|0.4504
71850004|NCT04421456|143213790|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm and visit by treatment arm interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.52||0.4195|TWO_SIDED|95.0|-4.22|1.76|||Mixed-effects repeated measures model|||||1.76|-4.22|0.4195
71818168|NCT01169259|143139672|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.85|1.12|||Regression, Cox|||||1.12|0.85|
71818169|NCT01169259|143139672|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.8|1.06|||Regression, Cox|||||1.06|0.80|
71818170|NCT01169259|143139673|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.02|||Regression, Cox|||||1.02|0.67|
71818171|NCT01169259|143139673|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||Regression, Cox|||||1.20|0.79|
71818172|NCT01169259|143139674|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.79|1.31|||Regression, Cox|||||1.31|0.79|
71818173|NCT01169259|143139674|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.7|1.16|||Regression, Cox|||||1.16|0.70|
71818174|NCT01169259|143139675|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.72|1.07|||Regression, Cox|||||1.07|0.72|
71818175|NCT01169259|143139675|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.94|1.39|||Regression, Cox|||||1.39|0.94|
71818176|NCT01169259|143139676|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.73|1.62|||Regression, Cox|||||1.62|0.73|
71818177|NCT01169259|143139676|SUPERIORITY||Hazard Ratio (HR)|1.23|||||TWO_SIDED|95.0|0.83|1.83|||Regression, Cox|||||1.83|0.83|
71818178|NCT01169259|143139677|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.86|1.08|||Regression, Cox|||||1.08|0.86|
71818179|NCT01169259|143139677|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.82|1.04|||Regression, Cox|||||1.04|0.82|
71818180|NCT01169259|143139678|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|||||1.19|0.78|
71818181|NCT01169259|143139678|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.59|0.9|||Regression, Cox|||||0.90|0.59|
71818182|NCT01169259|143139679|SUPERIORITY||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.76|1.2|||Regression, Cox|||||1.20|0.76|
71818183|NCT01169259|143139679|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.83|1.31|||Regression, Cox|||||1.31|0.83|
71818184|NCT01169259|143139680|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.88|1.4|||Regression, Cox|||||1.40|0.88|
71818185|NCT01169259|143139680|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|||||1.21|0.76|
71818186|NCT01169259|143139681|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.87|1.12|||Regression, Cox|||||1.12|0.87|
71818187|NCT01169259|143139681|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.9|1.15|||Regression, Cox|||||1.15|0.90|
71818188|NCT01169259|143139682|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.83|1.06|||Regression, Cox|||||1.06|0.83|
71818189|NCT01169259|143139682|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|1.0|1.28|||Regression, Cox|||||1.28|1.00|
71818190|NCT01169259|143139683|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.09|||Regression, Cox|||||1.09|0.79|
71818191|NCT01169259|143139683|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.76|1.05|||Regression, Cox|||||1.05|0.76|
71818192|NCT01169259|143139684|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.59|0.96|||Regression, Cox|||||0.96|0.59|
71818193|NCT01169259|143139684|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.73|1.19|||Regression, Cox|||||1.19|0.73|
71850005|NCT04421456|143213791|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.885|TWO_SIDED|95.0|-0.35|0.3|||Mixed-effects repeated measures model|||||0.30|-0.35|0.8850
71818194|NCT01169259|143139685|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.84|1.11|||Regression, Cox|||||1.11|0.84|
71818195|NCT01169259|143139685|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.84|1.12|||Regression, Cox|||||1.12|0.84|
71818196|NCT01169259|143139686|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|||||1.19|0.79|
71818197|NCT01169259|143139686|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.63|0.95|||Regression, Cox|||||0.95|0.63|
71818198|NCT01169259|143139687|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.55|1.01|||Regression, Cox|||||1.01|0.55|
71818199|NCT01169259|143139687|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.73|1.33|||Regression, Cox|||||1.33|0.73|
71818200|NCT01169259|143139688|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.83|1.12|||Regression, Cox|||||1.12|0.83|
71818201|NCT01169259|143139688|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.71|0.97|||Regression, Cox|||||0.97|0.71|
71818202|NCT01169259|143139689|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.83|1.39|||Regression, Cox|||||1.39|0.83|
71818203|NCT01169259|143139689|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.74|1.24|||Regression, Cox|||||1.24|0.74|
71818204|NCT01169259|143139690|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.42|1.38|||Regression, Cox|||||1.38|0.42|
71818205|NCT01169259|143139690|SUPERIORITY||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|0.72|2.39|||Regression, Cox|||||2.39|0.72|
71818206|NCT01169259|143139691|SUPERIORITY||Hazard Ratio (HR)|1.6|||||TWO_SIDED|95.0|0.84|3.06|||Regression, Cox|||||3.06|0.84|
71818207|NCT01169259|143139691|SUPERIORITY||Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.26|0.97|||Regression, Cox|||||0.97|0.26|
71818208|NCT01169259|143139692|SUPERIORITY||Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.83|1.95|||Regression, Cox|||||1.95|0.83|
71818209|NCT01169259|143139692|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.49|1.16|||Regression, Cox|||||1.16|0.49|
71818210|NCT01169259|143139693|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.46|1.54|||Regression, Cox|||||1.54|0.46|
71818211|NCT01169259|143139693|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.6|2.01|||Regression, Cox|||||2.01|0.60|
71818212|NCT01169259|143139694|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||Regression, Cox|||||1.20|0.71|
71818213|NCT01169259|143139694|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.55|0.93|||Regression, Cox|||||0.93|0.55|
71818214|NCT01169259|143139695|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.92|1.27||||||||1.27|0.92|
71818215|NCT01169259|143139695|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.83|1.15||||||||1.15|0.83|
71818216|NCT01169259|143139696|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.82|1.26||||||||1.26|0.82|
71818217|NCT01169259|143139696|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.84|1.29||||||||1.29|0.84|
71818218|NCT01017120|143139703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA|||||||<0.001
71818219|NCT01017120|143139703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA|||||||<0.001
71818220|NCT01017120|143139703|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA|||||||<0.001
71818221|NCT01017120|143139704|SUPERIORITY_OR_OTHER||Percentage of participants|32.2|||<|0.001|TWO_SIDED|95.0|27.4|36.9|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||36.9|27.4|<0.001
71818222|NCT01017120|143139704|SUPERIORITY_OR_OTHER||Percentage of participants|18.2|||||TWO_SIDED|95.0|14.2|22.1|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.|||22.1|14.2|
71818223|NCT01017120|143139705|SUPERIORITY_OR_OTHER||Percentage of participants|27.6|||<|0.001|TWO_SIDED|95.0|23.1|32.2|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.|||32.2|23.1|<0.001
71818224|NCT01017120|143139705|SUPERIORITY_OR_OTHER||Percentage of participants|13.3|||||TWO_SIDED|95.0|9.8|16.7|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.|||16.7|9.8|
71818225|NCT01087723|143139730|SUPERIORITY_OR_OTHER||Relative risk|0.6||||0.0014|TWO_SIDED|95.0|0.43|0.82|||Chi-squared|||||0.82|0.43|0.0014
71818226|NCT00252590|143139739|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
71818227|NCT00806624|143139759|SUPERIORITY_OR_OTHER||difference in percentages|-3.5|||||TWO_SIDED|95.0|-16.2|9.4||||||||9.4|-16.2|
71818228|NCT00806624|143139759|SUPERIORITY_OR_OTHER||difference in percentages|-9.1|||||TWO_SIDED|95.0|-22.4|4.5||||||||4.5|-22.4|
71818229|NCT00806624|143139759|SUPERIORITY_OR_OTHER||difference in percentage|-5.6|||||TWO_SIDED|95.0|-19.3|8.2||||||||8.2|-19.3|
71818230|NCT01702428|143139793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|-0.54|||||TWO_SIDED|95.0|-1.69|0.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||0.58|-1.69|
71818231|NCT01702428|143139793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.79|||||TWO_SIDED|95.0|-0.35|1.98|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.98|-0.35|
71850006|NCT04421456|143213791|SUPERIORITY|The repeated measures model includes stratification factors (sex and region), associated baseline, visit, randomised treatment arm, visit by treatment arm interaction and visit by associated baseline interaction as fixed effects and visit repeated within each participant as a repeated effect.|Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.7808|TWO_SIDED|95.0|-0.36|0.27|||Mixed-effects repeated measures model|||||0.27|-0.36|0.7808
71850007|NCT04421456|143213792|SUPERIORITY||Odds Ratio (OR)|1.412||||0.6707|TWO_SIDED|95.0|0.288|6.924|||Regression, Logistic|||||6.924|0.288|0.6707
71818232|NCT01702428|143139793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to measles virus.|Difference in seroresponse rate|0.25|||||TWO_SIDED|95.0|-0.98|1.5|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.||1.50|-0.98|
71818233|NCT01702428|143139794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
71818234|NCT01702428|143139794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.05|0.90|
71850008|NCT04421456|143213792|SUPERIORITY||Odds Ratio (OR)|0.576||||0.4883|TWO_SIDED|95.0|0.121|2.744|||Regression, Logistic|||||2.744|0.121|0.4883
71850009|NCT01694199|143213808|SUPERIORITY_OR_OTHER|||||||0.3529|||||||ANCOVA|||||||0.3529
71850010|NCT01694199|143213809|SUPERIORITY_OR_OTHER|||||||0.2766|||||||ANCOVA|||||||0.2766
71850011|NCT01694199|143213810|SUPERIORITY_OR_OTHER|||||||0.1467|||||||ANOVA|||P=0.1467||||0.1467
71850012|NCT01694199|143213811|SUPERIORITY_OR_OTHER|||||||0.5009|||||||ANOVA|||P = 0.5009||||0.5009
71850013|NCT01694199|143213812|SUPERIORITY_OR_OTHER|||||||0.9038|||||||ANOVA|||||||0.9038
71850014|NCT03031782|143213834|SUPERIORITY||Cox Proportional Hazard|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.63|||Log Rank|Hazard ratios and associated 95% confidence intervals are based on a Cox proportional hazards model with treatment and analysis factors||Survival analysis of time to flare - TP2 (FAS2)||0.63|0.13|<0.001
71850015|NCT01930188|143213845|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-1.06|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.91|||Mixed Models Analysis|Post-baseline responses analysed with mixed model for repeated measurements-treatment \& country (fixed) \& baseline (covariate) all nested within visit||||-0.91|-1.21|<0.0001
71850016|NCT01930188|143213845|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.62|||Mixed Models Analysis|Analysis done with mixed model for repeated measurements (treatment \& country as fixed factors \& baseline value as covariate) all nested within visit||||-0.62|-1.21|<0.0001
71850017|NCT00886834|143213860|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
71850018|NCT03122860|143213862|SUPERIORITY||Median Difference (Final Values)|-0.46||||0.179|TWO_SIDED|95.0|-1.13|0.21|||ANCOVA|||||0.21|-1.13|0.179
71850019|NCT03122860|143213862|SUPERIORITY||Median Difference (Final Values)|-0.7||||0.031|TWO_SIDED|95.0|-1.34|-0.06|||ANCOVA|||||-0.06|-1.34|0.031
71850020|NCT03122860|143213862|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.675|TWO_SIDED|95.0|-0.81|0.52|||ANCOVA|||||0.52|-0.81|0.675
71850021|NCT03122860|143213862|SUPERIORITY||Mean Difference (Final Values)|-0.82||||0.022|TWO_SIDED|95.0|-1.51|-0.12|||ANCOVA|||||-0.12|-1.51|0.022
71850022|NCT03122860|143213862|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.78|TWO_SIDED|95.0|-0.79|0.59|||ANCOVA|||||0.59|-0.79|0.780
71850023|NCT03122860|143213863|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.612|TWO_SIDED|95.0|-8.32|4.91|||ANCOVA|||||4.91|-8.32|0.612
71850024|NCT03122860|143213863|SUPERIORITY||Mean Difference (Final Values)|-4.01||||0.223|TWO_SIDED|95.0|-10.47|2.46|||ANCOVA|||||2.46|-10.47|0.223
71850025|NCT03122860|143213863|SUPERIORITY||Mean Difference (Final Values)|1.84||||0.59|TWO_SIDED|95.0|-4.89|8.57|||ANCOVA|||||8.57|-4.89|0.590
71850026|NCT03122860|143213863|SUPERIORITY||Mean Difference (Final Values)|-7.36||||0.031|TWO_SIDED|95.0|-14.03|-0.69|||ANCOVA|||||-0.69|-14.03|0.031
71850027|NCT03122860|143213863|SUPERIORITY||Mean Difference (Final Values)|-2.89||||0.403|TWO_SIDED|95.0|-9.7|3.92|||ANCOVA|||||3.92|-9.70|0.403
71850028|NCT03122860|143213864|SUPERIORITY||Mean Difference (Final Values)|-2.58||||0.432|TWO_SIDED|95.0|-9.04|3.88|||ANCOVA|||||3.88|-9.04|0.432
71850029|NCT03122860|143213864|SUPERIORITY||Mean Difference (Final Values)|-4.34||||0.18|TWO_SIDED|95.0|-10.69|2.02|||ANCOVA|||||2.02|-10.69|0.180
71850030|NCT03122860|143213864|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.718|TWO_SIDED|95.0|-5.33|7.72|||ANCOVA|||||7.72|-5.33|0.718
71850031|NCT03122860|143213864|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.017|TWO_SIDED|95.0|-14.54|-1.45|||ANCOVA|||||-1.45|-14.54|0.017
71850032|NCT03122860|143213864|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.682|TWO_SIDED|95.0|-8.06|5.29|||ANCOVA|||||5.29|-8.06|0.682
71850033|NCT03122860|143213865|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.822|TWO_SIDED|95.0|-0.16|0.21|||ANCOVA|||||0.21|-0.16|0.822
71850034|NCT03122860|143213865|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.162|TWO_SIDED|95.0|-0.27|0.04|||ANCOVA|||||0.04|-0.27|0.162
71850035|NCT03122860|143213865|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.267|TWO_SIDED|95.0|-0.34|0.09|||ANCOVA|||||0.09|-0.34|0.267
71850036|NCT03122860|143213865|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.685|TWO_SIDED|95.0|-0.18|0.12|||ANCOVA|||||0.12|-0.18|0.685
71850037|NCT03122860|143213865|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.342|TWO_SIDED|95.0|-0.09|0.24|||ANCOVA|||||0.24|-0.09|0.342
71850038|NCT03122860|143213866|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5|TWO_SIDED|95.0|-8.36|4.1|||ANCOVA|||||4.10|-8.36|0.500
71850039|NCT03122860|143213866|SUPERIORITY||Mean Difference (Final Values)|-5.54||||0.082|TWO_SIDED|95.0|-11.8|0.72|||ANCOVA|||||0.72|-11.80|0.082
71850040|NCT03122860|143213866|SUPERIORITY||Mean Difference (Final Values)|-1.94||||0.552|TWO_SIDED|95.0|-8.36|4.48|||ANCOVA|||||4.48|-8.36|0.552
71850041|NCT03122860|143213866|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.033|TWO_SIDED|95.0|-13.16|-0.56|||ANCOVA|||||-0.56|-13.16|0.033
71850042|NCT03122860|143213866|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.887|TWO_SIDED|95.0|-5.79|6.68|||ANCOVA|||||6.68|-5.79|0.887
71850043|NCT03122860|143213867|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.473|TWO_SIDED|95.0|-7.99|3.72|||ANCOVA|||||3.72|-7.99|0.473
71850044|NCT03122860|143213867|SUPERIORITY||Mean Difference (Final Values)|-6.31||||0.04|TWO_SIDED|95.0|-12.33|-0.29|||ANCOVA|||||-0.29|-12.33|0.040
71850045|NCT03122860|143213867|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.577|TWO_SIDED|95.0|-4.35|7.79|||ANCOVA|||||7.79|-4.35|0.577
71850046|NCT03122860|143213867|SUPERIORITY||Mean Difference (Final Values)|-8.95||||0.003|TWO_SIDED|95.0|-14.9|-3.01|||ANCOVA|||||-3.01|-14.90|0.003
71850047|NCT03122860|143213867|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.947|TWO_SIDED|95.0|-6.37|5.96|||ANCOVA|||||5.96|-6.37|0.947
71850048|NCT03122860|143213868|SUPERIORITY||Mean Difference (Final Values)|-3.05||||0.299|TWO_SIDED|95.0|-8.83|2.73|||ANCOVA|||||2.73|-8.83|0.299
71850049|NCT03122860|143213868|SUPERIORITY||Mean Difference (Final Values)|-7.18||||0.021|TWO_SIDED|95.0|-13.24|-1.12|||ANCOVA|||||-1.12|-13.24|0.021
71850050|NCT03122860|143213868|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.675|TWO_SIDED|95.0|-4.75|7.33|||ANCOVA|||||7.33|-4.75|0.675
71850051|NCT03122860|143213868|SUPERIORITY||Mean Difference (Final Values)|-8.63||||0.006|TWO_SIDED|95.0|-14.7|-2.55|||ANCOVA|||||-2.55|-14.70|0.006
71850052|NCT03122860|143213868|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.925|TWO_SIDED|95.0|-5.99|6.59|||ANCOVA|||||6.59|-5.99|0.925
71900536|NCT02749721|143322995|OTHER||F statistic|0.37||||0.546|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.546
71900537|NCT02749721|143322995|OTHER||F statistic|0.017||||0.895|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.895
71900538|NCT02749721|143322995|OTHER||F statistic|0.179||||0.673|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.673
71900539|NCT02749721|143322995|OTHER||F statistic|1.241||||0.27|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.27
71818235|NCT01702428|143139794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
71818236|NCT01702428|143139794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.06|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to measles virus at Day 42.||1.06|0.91|
71818237|NCT01702428|143139794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.03|||||TWO_SIDED|95.0|0.95|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to measles virus at Day 42.||1.11|0.95|
71818238|NCT01702428|143139794|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.94|1.09|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to measles virus at Day 42.||1.09|0.94|
71818239|NCT01702428|143139795|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.02|||||TWO_SIDED|95.0|-1.05|1.09|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.09|-1.05|
71818240|NCT01702428|143139795|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.63|||||TWO_SIDED|95.0|-0.5|1.81|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.81|-0.50|
71818241|NCT01702428|143139795|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.61|||||TWO_SIDED|95.0|-0.53|1.79|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.||1.79|-0.53|
71818242|NCT01702428|143139796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|1.0|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||1.00|0.87|
71900540|NCT02749721|143322995|OTHER||F statistic|0.042||||0.837|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a amplitudes at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.837
71900541|NCT02749721|143322996|OTHER||Pearson's R|0.359||||0.143|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline scores||||0.143
71900542|NCT02749721|143322996|OTHER||Pearson's R|-0.197||||0.5|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.500
71818243|NCT01702428|143139796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.97|1.11|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.11|0.97|
71818244|NCT01702428|143139796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.07|||||TWO_SIDED|95.0|1.0|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.15|1.00|
71818245|NCT01702428|143139796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.04|1.19|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to mumps virus at Day 42.||1.19|1.04|
71818246|NCT01702428|143139796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.9|1.03|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to mumps virus at Day 42.||1.03|0.90|
71818247|NCT01702428|143139796|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to mumps.|Adjusted GMC ratio|0.9|||||TWO_SIDED|95.0|0.84|0.96|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to mumps virus at Day 42.||0.96|0.84|
71818248|NCT01702428|143139797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|0.14|||||TWO_SIDED|95.0|-1.3|1.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||1.58|-1.3|
71818249|NCT01702428|143139797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.49|||||TWO_SIDED|95.0|-1.86|0.86|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L1 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.86|-1.86|
71850053|NCT03122860|143213869|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.062|TWO_SIDED|95.0|-1.18|0.03|||ANCOVA|||||0.03|-1.18|0.062
71850054|NCT03122860|143213869|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.001|TWO_SIDED|95.0|-1.54|-0.37|||ANCOVA|||||-0.37|-1.54|0.001
71850055|NCT03122860|143213869|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.693|TWO_SIDED|95.0|-0.75|0.5|||ANCOVA|||||0.50|-0.75|0.693
71850056|NCT03122860|143213869|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.012|TWO_SIDED|95.0|-1.39|-0.17|||ANCOVA|||||-0.17|-1.39|0.012
71850057|NCT03122860|143213869|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.697|TWO_SIDED|95.0|-0.49|0.74|||ANCOVA|||||0.74|-0.49|0.697
71818250|NCT01702428|143139797|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the \[-5%;5%\] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.62|||||TWO_SIDED|95.0|-2.02|0.74|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV\_MMR\_L2 Group minus INV\_MMR\_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.||0.74|-2.02|
71818251|NCT01702428|143139798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||"Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.~."||1.15|1.01|
71850058|NCT03122860|143213870|SUPERIORITY||Mean Difference (Final Values)|-3.32||||0.254|TWO_SIDED|95.0|-9.04|2.4|||ANCOVA|||||2.40|-9.04|0.254
71850059|NCT03122860|143213870|SUPERIORITY||Mean Difference (Final Values)|-6.86||||0.031|TWO_SIDED|95.0|-13.1|-0.63|||ANCOVA|||||-0.63|-13.10|0.031
71850060|NCT03122860|143213870|SUPERIORITY||Mean Difference (Final Values)|-1.46||||0.616|TWO_SIDED|95.0|-7.2|4.28|||ANCOVA|||||4.28|-7.20|0.616
71850061|NCT03122860|143213870|SUPERIORITY||Mean Difference (Final Values)|-7.62||||0.01|TWO_SIDED|95.0|-13.41|-1.82|||ANCOVA|||||-1.82|-13.41|0.010
71850062|NCT03122860|143213870|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.961|TWO_SIDED|95.0|-5.74|5.46|||ANCOVA|||||5.46|-5.74|0.961
71818252|NCT01702428|143139798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.94|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L1 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||1.07|0.94|
71818253|NCT01702428|143139798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
71818254|NCT01702428|143139798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L2 Group divided by INV\_MMR\_L3 Group) for antibodies to rubella virus at Day 42.||0.99|0.87|
71818255|NCT01702428|143139798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||TWO_SIDED|95.0|0.93|1.07|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L1 Group) for antibodies to rubella virus at Day 42.||1.07|0.93|
71818256|NCT01702428|143139798|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the \[0.67;1.5\] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||TWO_SIDED|95.0|1.01|1.15|||ANOVA|95% CI for GMC of each INV\_MMR lots pair was computed using ANOVA (3 INV\_MMR lot groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR\_L3 Group divided by INV\_MMR\_L2 Group) for antibodies to rubella virus at Day 42.||1.15|1.01|
71818257|NCT01702428|143139799|NON_INFERIORITY|The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to measles virus.|Difference in seroresponse rate|0.18|||||TWO_SIDED|95.0|-0.68|1.25|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-measles antibody concentration at Day 42.||1.25|-0.68|
71818258|NCT01702428|143139800|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.93|1.05|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to measles virus at Day 42.||1.05|0.93|
71818259|NCT01702428|143139801|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to mumps virus.|Difference in seroresponse rate|0.81|||||TWO_SIDED|95.0|-0.1|1.96|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.||1.96|-0.1|
71818260|NCT01702428|143139802|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to mumps virus.|Adjusted GMC ratio|1.05|||||TWO_SIDED|95.0|0.99|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to mumps virus at Day 42.||1.11|0.99|
71850063|NCT01138657|143213871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.36|0.7|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.70|0.36|<0.001
71850064|NCT01138657|143213871|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.4|0.76|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.76|0.40|< 0.001
71818261|NCT01702428|143139803|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (INV\_MMR Group minus COM\_MMR Group) should be ≥-5% for antibodies to rubella virus.|Difference in seroresponse rate|-1.15|||||TWO_SIDED|95.0|-2.0|-0.15|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.||-0.15|-2.00|
71818262|NCT01702428|143139804|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.87|||||TWO_SIDED|95.0|0.83|0.92|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to rubella virus at Day 42.||0.92|0.83|
71818263|NCT01702428|143139805|NON_INFERIORITY|The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV\_MMR Group minus pooled COM\_MMR Group) should be ≥-10% for antibodies to VZV.|Difference in seroresponse rate|1.3|||||TWO_SIDED|95.0|-1.31|4.29|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|In US sub-cohort: Difference in percentage (INV\_MMR Group minus COM\_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.||4.29|-1.31|
71900543|NCT02749721|143322996|OTHER||Pearson's R|0.277||||0.337|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (latency) baseline scores||||0.337
71900544|NCT02749721|143322996|OTHER||Pearson's R|0.052||||0.832|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (latency) baseline scores||||0.832
71900545|NCT02749721|143322996|OTHER||Pearson's R|0.103||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (latency) baseline scores||||0.68
71900546|NCT02749721|143322996|OTHER||Pearson's R|-0.074||||0.777|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P200 (Latency) baseline to endpoint percentage change||||0.777
71900547|NCT02749721|143322996|OTHER||Pearson's R|0.061||||0.834|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3a (Latency) baseline to endpoint percentage change||||0.834
71900548|NCT02749721|143322996|OTHER||Pearson's R|-0.006||||0.988|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and AOB P3b (Latency) baseline to endpoint percentage change||||0.988
71900549|NCT02749721|143322996|OTHER||Pearson's R|0.073||||0.788|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P200 (Latency) baseline to endpoint percentage change||||0.788
71900550|NCT02749721|143322996|OTHER||Pearson's R|0.375||||0.168|TWO_SIDED||||||Pearson's correlation|||Correlation between DSST and VGNG P3a (Latency) baseline to endpoint percentage change||||0.168
71900551|NCT02749721|143322996|OTHER||Pearson's R|-0.392||||0.108|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline scores||||0.108
71900552|NCT02749721|143322996|OTHER||Pearson's R|0.415||||0.124|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline scores||||0.124
71900553|NCT02749721|143322996|OTHER||Pearson's R|0.362||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline scores||||0.185
71900554|NCT02749721|143322996|OTHER||Pearson's R|-0.023||||0.923|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline scores||||0.923
71900555|NCT02749721|143322996|OTHER||Pearson's R|0.071||||0.77|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline scores||||0.77
71900556|NCT02749721|143322996|OTHER||Pearson's R|0.097||||0.712|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P200 (Latency) baseline to endpoint percent change||||0.712
71900557|NCT02749721|143322996|OTHER||Pearson's R|-0.058||||0.845|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3a (Latency) baseline to endpoint percent change||||0.845
71900558|NCT02749721|143322996|OTHER||Pearson's R|0.194||||0.616|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and AOB P3b (Latency) baseline to endpoint percent change||||0.616
71900559|NCT02749721|143322996|OTHER||Pearson's R|0.255||||0.323|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P200 (Latency) baseline to endpoint percent change||||0.323
71900560|NCT02749721|143322996|OTHER||Pearson's R|-0.193||||0.473|TWO_SIDED||||||Pearson's correlation|||Correlation between MADRS and VGNG P3a (Latency) baseline to endpoint percent change||||0.473
71900561|NCT02749721|143322996|OTHER||F statistic|4.909||||0.031|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.031
71900562|NCT02749721|143322996|OTHER||F statistic|1.189||||0.281|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.281
71900563|NCT02749721|143322996|OTHER||F statistic|0.001||||0.966|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.966
71900564|NCT02749721|143322996|OTHER||F statistic|4.121||||0.048|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.048
71900565|NCT02749721|143322996|OTHER||F statistic|8.573||||0.005|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.005
71900566|NCT02749721|143322996|OTHER||F statistic|2.823||||0.101|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' AOB P3b latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.101
71900567|NCT02749721|143322996|OTHER||F statistic|0.806||||0.373|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.373
71900568|NCT02749721|143322996|OTHER||F statistic|1.822||||0.183|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P200 latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.183
71900569|NCT02749721|143322996|OTHER||F statistic|0.516||||0.475|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at baseline.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.475
71900570|NCT02749721|143322996|OTHER||F statistic|0.214||||0.645|TWO_SIDED||||||ANCOVA|||"A comparison between vortioxetine arm patients' and healthy controls' VGNG P3a latencies at Endpoint.~The healthy control group subjects have been previously documented in NCT02418208 (Clinical trials of the Rockies, Inc. Denver, Colorado, US and Clinical Research Center of Nevada Las Vegas, Nevada, US ) and in NCT02875496 (The Villages Health, The Villages, Florida, US)."||||0.645
71900571|NCT02749721|143322997|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71900572|NCT02749721|143322998|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71900573|NCT02749721|143322999|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71900574|NCT02749721|143323000|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71900575|NCT02749721|143323001|OTHER||Pearson's R|-0.044||||0.859|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline scores||||0.859
71900576|NCT02749721|143323001|OTHER||Pearson's R|-0.211||||0.451|TWO_SIDED||||||Pearson's correlation|||AOB P3a (amplitude)||||0.451
71900577|NCT02749721|143323001|OTHER||Pearson's R|0.015||||0.957|TWO_SIDED||||||Pearson's correlation|||AOB P3b (amplitude)||||0.957
71900578|NCT02749721|143323001|OTHER||Pearson's R|-0.322||||0.166|TWO_SIDED||||||Pearson's correlation|||VGNG P200 (amplitude)||||0.166
71900579|NCT02749721|143323001|OTHER||Pearson's R|-0.374||||0.105|TWO_SIDED||||||Pearson's correlation|||VGNG P3a (amplitude)||||0.105
71900580|NCT02749721|143323001|OTHER||Pearson's R|-0.137||||0.601|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-28 baseline to endpoint percent change||||0.601
71900581|NCT02749721|143323001|OTHER||Pearson's R|-0.234||||0.421|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.421
71900582|NCT02749721|143323001|OTHER||Pearson's R|0.378||||0.316|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-28 baseline to endpoint percent change||||0.316
71900583|NCT02749721|143323001|OTHER||Pearson's R|0.185||||0.478|TWO_SIDED||||||Pearson's correlation|||||||0.478
71900584|NCT02749721|143323001|OTHER||Pearson's R|0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-28 baseline to endpoint percent change||||0.969
71900585|NCT02749721|143323001|OTHER||Pearson's R|-0.018||||0.943|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline scores||||0.943
71900586|NCT02749721|143323001|OTHER||Pearson's R|-0.074||||0.795|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline scores||||0.795
71900587|NCT02749721|143323001|OTHER||Pearson's R|-0.011||||0.969|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline scores||||0.969
71900588|NCT02749721|143323001|OTHER||Pearson's R|-0.197||||0.406|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline scores||||0.406
71900589|NCT02749721|143323001|OTHER||Pearson's R|-0.309||||0.185|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline scores||||0.185
71900590|NCT02749721|143323001|OTHER||Pearson's R|-0.195||||0.454|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.454
71900591|NCT02749721|143323001|OTHER||Pearson's R|-0.162||||0.579|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.579
71900592|NCT02749721|143323001|OTHER||Pearson's R|0.232||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and HDRS-17 baseline to endpoint percent change||||0.549
71900593|NCT02749721|143323001|OTHER||Pearson's R|0.169||||0.518|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and HDRS-17 baseline to endpoint percent change||||0.518
71900594|NCT02749721|143323001|OTHER||Pearson's R|0.027||||0.922|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and HDRS-17 baseline to endpoint percent change||||0.922
71900595|NCT02749721|143323001|OTHER||Pearson's R|-0.064||||0.796|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline scores||||0.796
71900596|NCT02749721|143323001|OTHER||Pearson's R|-0.506||||0.054|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline scores||||0.054
71900597|NCT02749721|143323001|OTHER||Pearson's R|0.002||||0.995|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and QIDS-SR baseline scores||||0.995
71900598|NCT02749721|143323001|OTHER||Pearson's R|0.102||||0.668|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline scores||||0.668
71900599|NCT02749721|143323001|OTHER||Pearson's R|0.037||||0.875|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline scores||||0.875
71900600|NCT02749721|143323001|OTHER||Pearson's R|-0.049||||0.852|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.852
71679506|NCT02612610|142877071|OTHER||LS Mean Difference|-0.25||||0.0928|TWO_SIDED|95.0|-0.54|0.04|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||0.04|-0.54|0.0928
71900601|NCT02749721|143323001|OTHER||Pearson's R|-0.34||||0.234|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.234
71900602|NCT02749721|143323001|OTHER||Pearson's R|0.655||||0.056|TWO_SIDED||||||Pearson's correlation|||||||0.056
71900603|NCT02749721|143323001|OTHER||Pearson's R|0.297||||0.248|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and QIDS-SR baseline to endpoint percent change||||0.248
71900604|NCT02749721|143323001|OTHER||Pearson's R|0.179||||0.507|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and QIDS-SR baseline to endpoint percent change||||0.507
71900605|NCT02749721|143323001|OTHER||Pearson's R|0.049||||0.841|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline scores||||0.841
71900606|NCT02749721|143323001|OTHER||Pearson's R|-0.185||||0.508|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline scores||||0.508
71900607|NCT02749721|143323001|OTHER||Pearson's R|-0.03||||0.916|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline scores||||0.916
71900608|NCT02749721|143323001|OTHER||Pearson's R|-0.345||||0.147|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline scores||||0.147
71900609|NCT02749721|143323001|OTHER||Pearson's R|-0.284||||0.225|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline scores||||0.225
71900610|NCT02749721|143323001|OTHER||Pearson's R|-0.044||||0.868|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and PDQ baseline to endpoint percent change||||0.868
71850065|NCT01138657|143213872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.29||||0.011|TWO_SIDED|95.0|-0.51|-0.07|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.07|-0.51|0.011
71850066|NCT01138657|143213872|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.25||||0.019|TWO_SIDED|95.0|-0.46|-0.04|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.04|-0.46|0.019
71850067|NCT01138657|143213873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.43|-0.11|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.11|-0.43|<0.001
71850068|NCT01138657|143213873|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.43|-0.12|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.12|-0.43|<0.001
71900611|NCT02749721|143323001|OTHER||Pearson's R|-0.18||||0.537|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and PDQ baseline to endpoint percent change||||0.537
71900612|NCT02749721|143323001|OTHER||Pearson's R|0.476||||0.195|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and PDQ baseline to endpoint percent change||||0.195
71900613|NCT02749721|143323001|OTHER||Pearson's R|0.594||||0.015|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and PDQ baseline to endpoint percent change||||0.015
71900614|NCT02749721|143323001|OTHER||Pearson's R|-0.009||||0.972|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and PDQ baseline to endpoint percent change||||0.972
71900615|NCT02749721|143323001|OTHER||Pearson's R|0.067||||0.785|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline scores||||0.785
71900616|NCT02749721|143323001|OTHER||Pearson's R|-0.129||||0.646|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline scores||||0.646
71900617|NCT02749721|143323001|OTHER||Pearson's R|0.364||||0.182|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline scores||||0.182
71900618|NCT02749721|143323001|OTHER||Pearson's R|-0.414||||0.069|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline scores||||0.069
71900619|NCT02749721|143323001|OTHER||Pearson's R|-0.416||||0.068|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline scores||||0.068
71900620|NCT02749721|143323001|OTHER||Pearson's R|-0.023||||0.929|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.929
71900621|NCT02749721|143323001|OTHER||Pearson's R|-0.074||||0.802|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.802
71850069|NCT01138657|143213874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.07||||0.003|TWO_SIDED|95.0|-0.11|-0.02|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.11|0.003
71850070|NCT01138657|143213874|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.06||||0.008|TWO_SIDED|95.0|-0.1|-0.02|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.02|-0.10|0.008
71850071|NCT01138657|143213875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.231|TWO_SIDED|95.0|0.39|1.26|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.26|0.39|0.231
71850072|NCT01138657|143213875|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68||||0.191|TWO_SIDED|95.0|0.38|1.21|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.21|0.38|0.191
71850073|NCT01138657|143213876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-11.4||||0.02|TWO_SIDED|95.0|-20.9|-1.8|||ANOVA|ANOVA with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-1.8|-20.9|0.020
71850074|NCT01138657|143213876|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-5.1||||0.428|TWO_SIDED|95.0|-17.7|7.5|||Chi-squared, Corrected|ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.5|-17.7|0.428
71850075|NCT01138657|143213877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.2||||0.01|TWO_SIDED|95.0|1.02|7.38|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||7.38|1.02|0.010
71850076|NCT01138657|143213877|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|3.67||||0.019|TWO_SIDED|95.0|0.62|6.71|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.71|0.62|0.019
71850077|NCT01138657|143213878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.86||||0.346|TWO_SIDED|95.0|-2.03|5.75|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.75|-2.03|0.346
71850078|NCT01138657|143213878|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.31||||0.496|TWO_SIDED|95.0|-2.47|5.09|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.09|-2.47|0.496
71850079|NCT01138657|143213879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|5.12||||0.036|TWO_SIDED|95.0|0.34|9.9|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||9.90|0.34|0.036
71850080|NCT01138657|143213879|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|4.14||||0.077|TWO_SIDED|95.0|-0.45|8.72|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||8.72|-0.45|0.077
71850081|NCT01138657|143213880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|10.02|||<|0.001|TWO_SIDED|95.0|4.86|15.19|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||15.19|4.86|<0.001
71850082|NCT01138657|143213880|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|8.83|||<|0.001|TWO_SIDED|95.0|3.88|13.79|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%||13.79|3.88|<0.001
71850083|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|4.1|||||TWO_SIDED|95.0|-0.9|9.2||||||Tx 1 - SBP (Unadjusted)||9.2|-0.9|
71850084|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.4|5.3||||||Tx 1 - DBP (Unadjusted)||5.3|-0.4|
71850085|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.2|5.6||||||Wk 3 - SBP (Unadjusted)||5.6|-6.2|
71850086|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-4.0|3.5||||||Wk 3 - DBP (Unadjusted)||3.5|-4.0|
71850087|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-1.9|8.9||||||Wk 6 - SBP (Unadjusted)||8.9|-1.9|
71850088|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-2.1|5.0||||||Wk 6 - DBP (Unadjusted)||5.0|-2.1|
71850089|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|4.7|||||TWO_SIDED|95.0|-0.4|9.8||||||Tx 1 - SBP (Adjusted)||9.8|-0.4|
71850090|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|0.6|6.5||||||Tx 1 - DBP (Adjusted)||6.5|0.6|
71850091|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-5.0|6.9||||||Wk 3 - SBP (Adjusted)||6.9|-5.0|
71850092|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.8|4.9||||||Wk 3 - DBP (Adjusted)||4.9|-2.8|
71850093|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-0.4|10.0||||||Wk 6 - SBP (Adjusted)||10.0|-0.4|
71850094|NCT01020435|143213898|OTHER||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|-1.2|5.8||||||Wk 6 - DBP (Adjusted)||5.8|-1.2|
71679507|NCT02612610|142877071|OTHER||LS Mean Difference|-0.46||||0.0027|TWO_SIDED|95.0|-0.76|-0.16|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.||-0.16|-0.76|0.0027
71850095|NCT02978183|143213910|SUPERIORITY|||||||0.0882||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0882
71850096|NCT02978183|143213910|SUPERIORITY|||||||0.8032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 5 Minutes Post-CAC||||0.8032
71850097|NCT02978183|143213910|SUPERIORITY|||||||0.9003||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 7 Minutes Post-CAC||||0.9003
71850098|NCT02978183|143213910|SUPERIORITY|||||||0.9523||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9523
71850099|NCT02978183|143213910|SUPERIORITY|||||||0.9071||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9071
71850100|NCT02978183|143213910|SUPERIORITY|||||||0.7509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7509
71850101|NCT02978183|143213910|SUPERIORITY|||||||0.2824||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.2824
71850102|NCT02978183|143213910|SUPERIORITY|||||||0.4017||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.4017
71850103|NCT02978183|143213910|SUPERIORITY|||||||0.4497||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.4497
71850104|NCT02978183|143213910|SUPERIORITY|||||||0.165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.1650
71900622|NCT02749721|143323001|OTHER||Pearson's R|0.518||||0.153|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.153
71900623|NCT02749721|143323001|OTHER||Pearson's R|0.268||||0.298|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.298
71900624|NCT02749721|143323001|OTHER||Pearson's R|-0.001||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and MGH-CPFQ baseline to endpoint percent change||||0.996
71850105|NCT02978183|143213910|SUPERIORITY|||||||0.3494||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 5 Minutes Post-CAC||||0.3494
71850106|NCT02978183|143213910|SUPERIORITY|||||||0.4781||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 7 Minutes Post-CAC||||0.4781
71850107|NCT02978183|143213910|SUPERIORITY|||||||0.9847||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.9847
71850108|NCT02978183|143213910|SUPERIORITY|||||||0.9731||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.9731
71850109|NCT02978183|143213910|SUPERIORITY|||||||0.6984||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6984
71850110|NCT02978183|143213910|SUPERIORITY|||||||0.6265||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.6265
71850111|NCT02978183|143213910|SUPERIORITY|||||||0.7848||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7848
71850112|NCT02978183|143213910|SUPERIORITY|||||||0.5789||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.5789
71850113|NCT02978183|143213911|SUPERIORITY|||||||0.8165||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8165
71850114|NCT02978183|143213911|SUPERIORITY|||||||0.659||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.6590
71850115|NCT02978183|143213911|SUPERIORITY|||||||0.7455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7455
71850116|NCT02978183|143213911|SUPERIORITY|||||||0.9212||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9212
71850117|NCT02978183|143213911|SUPERIORITY|||||||0.9509||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.9509
71850118|NCT02978183|143213911|SUPERIORITY|||||||0.7897||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7897
71850119|NCT02978183|143213911|SUPERIORITY|||||||0.3183||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.3183
71850120|NCT02978183|143213911|SUPERIORITY|||||||0.7604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.7604
71850121|NCT02978183|143213911|SUPERIORITY|||||||0.7343||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7343
71850122|NCT02978183|143213911|SUPERIORITY|||||||0.153||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.1530
71850123|NCT02978183|143213911|SUPERIORITY|||||||0.3307||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.3307
71850124|NCT02978183|143213911|SUPERIORITY|||||||0.3399||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3399
71850125|NCT02978183|143213911|SUPERIORITY|||||||0.5137||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5137
71850126|NCT02978183|143213911|SUPERIORITY|||||||0.9962||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9962
71850127|NCT02978183|143213912|SUPERIORITY|||||||0.3259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3259
71850128|NCT02978183|143213912|SUPERIORITY|||||||0.9785||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9785
71850129|NCT02978183|143213912|SUPERIORITY|||||||0.5112||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5112
71850130|NCT02978183|143213912|SUPERIORITY|||||||0.7771||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7771
71850131|NCT02978183|143213912|SUPERIORITY|||||||0.6232||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.6232
71850132|NCT02978183|143213912|SUPERIORITY|||||||0.8895||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.8895
71850133|NCT02978183|143213912|SUPERIORITY|||||||0.8974||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8974
71850134|NCT02978183|143213912|SUPERIORITY|||||||0.9604||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.9604
71900625|NCT02749721|143323001|OTHER||Pearson's R|0.242||||0.531|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline scores||||0.531
71900626|NCT02749721|143323001|OTHER||Pearson's R|-0.598||||0.21|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline scores||||0.210
71900627|NCT02749721|143323001|OTHER||Pearson's R|0.054||||0.899|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline scores||||0.899
71900628|NCT02749721|143323001|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||||||0.087
71900629|NCT02749721|143323001|OTHER||Pearson's R|0.568||||0.087|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline scores||||0.087
71900630|NCT02749721|143323001|OTHER||Pearson's R|0.231||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (amplitude) and WLQ baseline to endpoint percent change||||0.550
71900631|NCT02749721|143323001|OTHER||Pearson's R|0.158||||0.766|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (amplitude) and WLQ baseline to endpoint percent change||||0.766
71818264|NCT01702428|143139806|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.67 for antibodies to VZV.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.95|1.08|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to VZV virus at Day 42.||1.08|0.95|
71818265|NCT01702428|143139808|NON_INFERIORITY|The LL of the 2-sided 95% CI on GMC ratio (INV\_MMR Group over COM\_MMR Group) was ≥0.5 for antibodies to HAV virus.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.86|1.11|||ANOVA|95% CI for GMC ratio (INV\_MMR over COM\_ MMR) was computed using ANOVA (vaccine groups \& country as fixed effects) on log-transformed concentrations.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for antibodies to HAV virus at Day 42.||1.11|0.86|
71818266|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 1 antibody at Day 42.||1.05|0.85|
71818267|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.91|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 3 antibody at Day 42.||1.08|0.91|
71900632|NCT02749721|143323001|OTHER||Pearson's R|-0.406||||0.498|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (amplitude) and WLQ baseline to endpoint percent change||||0.498
71900633|NCT02749721|143323001|OTHER||Pearson's R|0.221||||0.599|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (amplitude) and WLQ baseline to endpoint percent change||||0.599
71900634|NCT02749721|143323001|OTHER||Pearson's R|0.679||||0.064|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (amplitude) and WLQ baseline to endpoint percent change||||0.064
71900635|NCT02749721|143323002|OTHER||Pearson's R|-0.038||||0.881|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline scores||||0.881
71900636|NCT02749721|143323002|OTHER||Pearson's R|0.299||||0.279|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline scores||||0.279
71900637|NCT02749721|143323002|OTHER||Pearson's R|0.538||||0.039|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline scores||||0.039
71900638|NCT02749721|143323002|OTHER||Pearson's R|-0.018||||0.94|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline scores||||0.940
71900639|NCT02749721|143323002|OTHER||Pearson's R|0.107||||0.65|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline scores||||0.65
71900640|NCT02749721|143323002|OTHER||Pearson's R|0.247||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.340
71900641|NCT02749721|143323002|OTHER||Pearson's R|0.067||||0.819|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.819
71900642|NCT02749721|143323002|OTHER||Pearson's R|0.321||||0.4|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-28 baseline to endpoint percentage change||||0.400
71900643|NCT02749721|143323002|OTHER||Pearson's R|0.279||||0.278|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-28 baseline to endpoint percentage change||||0.278
71900644|NCT02749721|143323002|OTHER||Pearson's R|-0.136||||0.614|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-28 baseline to endpoint percentage change||||0.614
71900645|NCT02749721|143323002|OTHER||Pearson's R|0.0||||0.999|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline scores||||0.999
71900646|NCT02749721|143323002|OTHER||Pearson's R|0.193||||0.491|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline scores||||0.491
71818268|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.88||||||95.0|0.79|0.98|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 4 antibody at Day 42.||0.98|0.79|
71850135|NCT02978183|143213912|SUPERIORITY|||||||0.5301||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 minutes Post-CAC||||0.5301
71850136|NCT02978183|143213912|SUPERIORITY|||||||0.0386||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0386
71850137|NCT02978183|143213912|SUPERIORITY|||||||0.1034||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.1034
71850138|NCT02978183|143213912|SUPERIORITY|||||||0.0985||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0985
71850139|NCT02978183|143213912|SUPERIORITY|||||||0.2342||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2342
71850140|NCT02978183|143213912|SUPERIORITY|||||||0.3016||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3016
71850141|NCT02978183|143213913|SUPERIORITY|||||||0.4927||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4927
71850142|NCT02978183|143213913|SUPERIORITY|||||||0.8686||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8686
71850143|NCT02978183|143213913|SUPERIORITY|||||||0.5772||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.5772
71850144|NCT02978183|143213913|SUPERIORITY|||||||0.97||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.9700
71850145|NCT02978183|143213913|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.7516
71850146|NCT02978183|143213913|SUPERIORITY|||||||0.9532||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9532
71850147|NCT02978183|143213913|SUPERIORITY|||||||0.7522||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.7522
71850148|NCT02978183|143213913|SUPERIORITY|||||||0.6804||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6804
71850149|NCT02978183|143213913|SUPERIORITY|||||||0.6267||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.6267
71850150|NCT02978183|143213913|SUPERIORITY|||||||0.0976||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.0976
71850151|NCT02978183|143213913|SUPERIORITY|||||||0.4687|||||||ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4687
71850152|NCT02978183|143213913|SUPERIORITY|||||||0.0421||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.0421
71850153|NCT02978183|143213913|SUPERIORITY|||||||0.6085||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.6085
71850154|NCT02978183|143213913|SUPERIORITY|||||||0.9634||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.9634
71850155|NCT02978183|143213914|SUPERIORITY|||||||0.3322||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.3322
71850156|NCT02978183|143213914|SUPERIORITY|||||||0.8026||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Pre-CAC||||0.8026
71850157|NCT02978183|143213914|SUPERIORITY|||||||0.9981||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Pre-CAC||||0.9981
71850158|NCT02978183|143213914|SUPERIORITY|||||||0.5645||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5645
71850159|NCT02978183|143213914|SUPERIORITY|||||||0.5455||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5455
71850160|NCT02978183|143213914|SUPERIORITY|||||||0.698||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6980
71850161|NCT02978183|143213914|SUPERIORITY|||||||0.6115||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6115
71850162|NCT02978183|143213914|SUPERIORITY|||||||0.4528||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.4528
71850163|NCT02978183|143213914|SUPERIORITY|||||||0.7551||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7551
71850164|NCT02978183|143213914|SUPERIORITY|||||||0.5318||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.5318
71900647|NCT02749721|143323002|OTHER||Pearson's R|0.567||||0.028|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline scores||||0.028
71900648|NCT02749721|143323002|OTHER||Pearson's R|-0.03||||0.9|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and HDRS-17 baseline scores||||0.900
71900649|NCT02749721|143323002|OTHER||Pearson's R|0.141||||0.55|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline scores||||0.55
71900650|NCT02749721|143323002|OTHER||Pearson's R|0.231||||0.373|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.373
71900651|NCT02749721|143323002|OTHER||Pearson's R|0.019||||0.949|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.949
71900652|NCT02749721|143323002|OTHER||Pearson's R|0.122||||0.754|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and HDRS-17 baseline to endpoint percent change||||0.754
71900653|NCT02749721|143323002|OTHER||Pearson's R|0.176||||0.499|TWO_SIDED||||||0.176|||Correlation between VGNG P200 (latency) and HDRS-17 baseline to endpoint percent change||||0.499
71900654|NCT02749721|143323002|OTHER||Pearson's R|-0.162||||0.549|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and HDRS-17 baseline to endpoint percent change||||0.549
71900655|NCT02749721|143323002|OTHER||Pearson's R|-0.126||||0.617|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline scores||||0.617
71900656|NCT02749721|143323002|OTHER||Pearson's R|0.1||||0.722|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline scores||||0.722
71679508|NCT02612610|142877072|OTHER||LS Mean Difference|-0.19||||0.1914|TWO_SIDED|95.0|-0.47|0.09|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.09|-0.47|0.1914
71900657|NCT02749721|143323002|OTHER||Pearson's R|0.249||||0.371|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline scores||||0.371
71900658|NCT02749721|143323002|OTHER||Pearson's R|-0.072||||0.764|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline scores||||0.764
71900659|NCT02749721|143323002|OTHER||Pearson's R|-0.225||||0.34|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline scores||||0.34
71900660|NCT02749721|143323002|OTHER||Pearson's R|0.148||||0.57|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.570
71900661|NCT02749721|143323002|OTHER||Pearson's R|0.228||||0.434|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.434
71900662|NCT02749721|143323002|OTHER||Pearson's R|0.22||||0.569|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and QIDS-SR baseline to endpoint percent change||||0.569
71900663|NCT02749721|143323002|OTHER||Pearson's R|0.645||||0.005|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and QIDS-SR baseline to endpoint percent change||||0.005
71900664|NCT02749721|143323002|OTHER||Pearson's R|0.105||||0.698|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and QIDS-SR baseline to endpoint percent change||||0.698
71900665|NCT02749721|143323002|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline scores||||0.774
71900666|NCT02749721|143323002|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline score||||0.024
71900667|NCT02749721|143323002|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline scores||||0.603
71900668|NCT02749721|143323002|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline scores||||0.326
71900669|NCT02749721|143323002|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline scores||||0.68
71900670|NCT02749721|143323002|OTHER||Pearson's R|-0.073||||0.774|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and PDQ baseline to endpoint percent change||||0.774
71900671|NCT02749721|143323002|OTHER||Pearson's R|0.577||||0.024|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and PDQ baseline to endpoint percent change||||0.024
71900672|NCT02749721|143323002|OTHER||Pearson's R|0.146||||0.603|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and PDQ baseline to endpoint percent change||||0.603
71900673|NCT02749721|143323002|OTHER||Pearson's R|-0.232||||0.326|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and PDQ baseline to endpoint percent change||||0.326
71900674|NCT02749721|143323002|OTHER||Pearson's R|0.098||||0.68|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and PDQ baseline to endpoint percent change||||0.68
71900675|NCT02749721|143323002|OTHER||Pearson's R|-0.1||||0.692|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline scores||||0.692
71900676|NCT02749721|143323002|OTHER||Pearson's R|0.498||||0.059|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline scores||||0.059
71900677|NCT02749721|143323002|OTHER||Pearson's R|-0.332||||0.227|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline scores||||0.227
71900678|NCT02749721|143323002|OTHER||Pearson's R|-0.125||||0.6|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline scores||||0.600
71900679|NCT02749721|143323002|OTHER||Pearson's R|-0.096||||0.69|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline scores||||0.69
71900680|NCT02749721|143323002|OTHER||Pearson's R|0.259||||0.315|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.315
71900681|NCT02749721|143323002|OTHER||Pearson's R|0.002||||0.996|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.996
71900682|NCT02749721|143323002|OTHER||Pearson's R|0.234||||0.544|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and MGH-CPFQ baseline to endpoint percent change||||0.544
71850165|NCT02978183|143213914|SUPERIORITY|||||||0.9748||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.9748
71850166|NCT02978183|143213914|SUPERIORITY|||||||0.7706||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7706
71850167|NCT02978183|143213914|SUPERIORITY|||||||0.3414||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.3414
71850168|NCT02978183|143213914|SUPERIORITY|||||||0.4361||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.4361
71850169|NCT02978183|143213915|SUPERIORITY|||||||0.0603||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0603
71850170|NCT02978183|143213915|SUPERIORITY|||||||0.4857||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.4857
71850171|NCT02978183|143213915|SUPERIORITY|||||||0.9815||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.9815
71850172|NCT02978183|143213915|SUPERIORITY|||||||0.6213||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.6213
71850173|NCT02978183|143213915|SUPERIORITY|||||||0.1831||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.1831
71850174|NCT02978183|143213915|SUPERIORITY|||||||0.6489||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6489
71850175|NCT02978183|143213915|SUPERIORITY|||||||0.2622||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2622
71850176|NCT02978183|143213915|SUPERIORITY|||||||0.2397||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.2397
71850177|NCT02978183|143213915|SUPERIORITY|||||||0.3202||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.3202
71850178|NCT02978183|143213915|SUPERIORITY|||||||0.2663||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.2663
71850179|NCT02978183|143213915|SUPERIORITY|||||||0.5672||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5672
71850180|NCT02978183|143213915|SUPERIORITY|||||||0.5055||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5055
71850181|NCT02978183|143213915|SUPERIORITY|||||||0.8143||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8143
71850182|NCT02978183|143213915|SUPERIORITY|||||||0.6901||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6901
71850183|NCT02978183|143213916|SUPERIORITY|||||||0.4032||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.4032
71850184|NCT02978183|143213916|SUPERIORITY|||||||0.2946||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.2946
71850185|NCT02978183|143213916|SUPERIORITY|||||||0.2863||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2863
71850186|NCT02978183|143213916|SUPERIORITY|||||||0.0891||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.0891
71850187|NCT02978183|143213916|SUPERIORITY|||||||0.5347||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5347
71850188|NCT02978183|143213916|SUPERIORITY|||||||0.3733||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.3733
71850189|NCT02978183|143213916|SUPERIORITY|||||||0.2506||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.2506
71850190|NCT02978183|143213916|SUPERIORITY|||||||0.8667||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8667
71900683|NCT02749721|143323002|OTHER||Pearson's R|0.455||||0.066|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and MGH-CPFQ baseline to endpoint percent change||||0.066
71900684|NCT02749721|143323002|OTHER||Pearson's R|-0.28||||0.293|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and MGH-CPFQ baseline to endpoint percent change||||0.293
71900685|NCT02749721|143323002|OTHER||Pearson's R|0.783||||0.013|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline scores||||0.013
71900686|NCT02749721|143323002|OTHER||Pearson's R|0.135||||0.799|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline scores||||0.799
71900687|NCT02749721|143323002|OTHER||Pearson's R|0.506||||0.201|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline scores||||0.201
71900688|NCT02749721|143323002|OTHER||Pearson's R|-0.197||||0.586|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline scores||||0.586
71900689|NCT02749721|143323002|OTHER||Pearson's R|-0.024||||0.95|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline scores||||0.95
71900690|NCT02749721|143323002|OTHER||Pearson's R|0.039||||0.92|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P200 (latency) and WLQ baseline to endpoint percent change||||0.920
71900691|NCT02749721|143323002|OTHER||Pearson's R|0.113||||0.831|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3a (latency) and WLQ baseline to endpoint percent change||||0.831
71900692|NCT02749721|143323002|OTHER||Pearson's R|0.655||||0.23|TWO_SIDED||||||Pearson's correlation|||Correlation between AOB P3b (latency) and WLQ baseline to endpoint percent change||||0.230
71679509|NCT02612610|142877072|OTHER||LS Mean Difference|-0.05||||0.7099|TWO_SIDED|95.0|-0.33|0.23|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.23|-0.33|0.7099
71900693|NCT02749721|143323002|OTHER||Pearson's R|-0.602||||0.115|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P200 (latency) and WLQ baseline to endpoint percent change||||0.115
71900694|NCT02749721|143323002|OTHER||Pearson's R|-0.313||||0.45|TWO_SIDED||||||Pearson's correlation|||Correlation between VGNG P3a (latency) and WLQ baseline to endpoint percent change||||0.450
71900695|NCT02137772|143323003|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.5|||<|0.0001|TWO_SIDED|95.0|-32.5|-14.6||A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.6|-32.5|<0.0001
71900696|NCT02137772|143323004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
71900697|NCT02137772|143323005|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.3|||<|0.0001|TWO_SIDED|95.0|-39.9|-22.6||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.6|-39.9|<0.0001
71850191|NCT02978183|143213916|SUPERIORITY|||||||0.764||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7640
71850192|NCT02978183|143213916|SUPERIORITY|||||||0.8008||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8008
71850193|NCT02978183|143213916|SUPERIORITY|||||||0.4729||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.4729
71850194|NCT02978183|143213916|SUPERIORITY|||||||0.4742||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.4742
71850195|NCT02978183|143213916|SUPERIORITY|||||||0.2922||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.2922
71850196|NCT02978183|143213916|SUPERIORITY|||||||0.3657||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.3657
71850197|NCT02978183|143213917|SUPERIORITY|||||||0.66||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.6600
71850198|NCT02978183|143213917|SUPERIORITY|||||||0.6877||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.6877
71850199|NCT02978183|143213917|SUPERIORITY|||||||0.334||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.3340
71850200|NCT02978183|143213917|SUPERIORITY|||||||0.7874||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7874
71850201|NCT02978183|143213917|SUPERIORITY|||||||0.3812||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.3812
71850202|NCT02978183|143213917|SUPERIORITY|||||||0.6987|||||||ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.6987
71850203|NCT02978183|143213917|SUPERIORITY|||||||0.6832||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.6832
71850204|NCT02978183|143213917|SUPERIORITY|||||||0.8521||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.8521
71850205|NCT02978183|143213917|SUPERIORITY|||||||0.7516||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7516
71850206|NCT02978183|143213917|SUPERIORITY|||||||0.6252||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6252
71850207|NCT02978183|143213917|SUPERIORITY|||||||0.8321||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.8321
71850208|NCT02978183|143213917|SUPERIORITY|||||||0.8173||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.8173
71850209|NCT02978183|143213917|SUPERIORITY|||||||0.5445||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.5445
71850210|NCT02978183|143213917|SUPERIORITY|||||||0.681||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6810
71850211|NCT02978183|143213918|SUPERIORITY|||||||0.0111||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.0111
71850212|NCT02978183|143213918|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.3391
71850213|NCT02978183|143213918|SUPERIORITY|||||||0.239||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.2390
71850214|NCT02978183|143213918|SUPERIORITY|||||||0.3068||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.3068
71850215|NCT02978183|143213918|SUPERIORITY|||||||0.4914||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.4914
71850216|NCT02978183|143213918|SUPERIORITY|||||||0.5185||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.5185
71850217|NCT02978183|143213918|SUPERIORITY|||||||0.5262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.5262
71850218|NCT02978183|143213918|SUPERIORITY|||||||0.6098||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.6098
71850219|NCT02978183|143213918|SUPERIORITY|||||||0.8849||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.8849
71850220|NCT02978183|143213918|SUPERIORITY|||||||0.6941||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.6941
71850221|NCT02978183|143213918|SUPERIORITY|||||||0.5728||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.5728
71850222|NCT02978183|143213918|SUPERIORITY|||||||0.5931||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.5931
71850223|NCT02978183|143213918|SUPERIORITY|||||||0.7513||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.7513
71850224|NCT02978183|143213918|SUPERIORITY|||||||0.7297||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.7297
71850225|NCT02978183|143213919|SUPERIORITY|||||||0.1259||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.1259
71850226|NCT02978183|143213919|SUPERIORITY|||||||0.9234||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 Minutes Post-CAC||||0.9234
71850227|NCT02978183|143213919|SUPERIORITY|||||||0.8816||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.8816
71850228|NCT02978183|143213919|SUPERIORITY|||||||0.5703||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.5703
71850229|NCT02978183|143213919|SUPERIORITY|||||||0.5428||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.5428
71850230|NCT02978183|143213919|SUPERIORITY|||||||0.7454||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.7454
71850231|NCT02978183|143213919|SUPERIORITY|||||||0.8195||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.8195
71850232|NCT02978183|143213919|SUPERIORITY|||||||0.0909||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.0909
71850233|NCT02978183|143213919|SUPERIORITY|||||||0.4881||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.4881
71850234|NCT02978183|143213919|SUPERIORITY|||||||0.3391||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.3391
71850235|NCT02978183|143213919|SUPERIORITY|||||||0.6065||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.6065
71850236|NCT02978183|143213919|SUPERIORITY|||||||0.3393||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.3393
71850237|NCT02978183|143213919|SUPERIORITY|||||||0.8364||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8364
71850238|NCT02978183|143213919|SUPERIORITY|||||||0.8858||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.8858
71850239|NCT02978183|143213920|SUPERIORITY|||||||0.8818||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: Pre-CAC||||0.8818
71850240|NCT02978183|143213920|SUPERIORITY|||||||0.8679||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 10 minutes Post-CAC||||0.8679
71850241|NCT02978183|143213920|SUPERIORITY|||||||0.7856||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 15 Minutes Post-CAC||||0.7856
71850242|NCT02978183|143213920|SUPERIORITY|||||||0.7507||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 20 Minutes Post-CAC||||0.7507
71850243|NCT02978183|143213920|SUPERIORITY|||||||0.8189||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 25 Minutes Post-CAC||||0.8189
71850244|NCT02978183|143213920|SUPERIORITY|||||||0.9206||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: 30 Minutes Post-CAC||||0.9206
71850245|NCT02978183|143213920|SUPERIORITY|||||||0.9591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 7: All Post-CAC Time Points||||0.9591
71850246|NCT02978183|143213920|SUPERIORITY|||||||0.5302||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: Pre-CAC||||0.5302
71850247|NCT02978183|143213920|SUPERIORITY|||||||0.7591||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 10 Minutes Post-CAC||||0.7591
71850248|NCT02978183|143213920|SUPERIORITY|||||||0.8978||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 15 Minutes Post-CAC||||0.8978
71850249|NCT02978183|143213920|SUPERIORITY|||||||0.7179||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 20 Minutes Post-CAC||||0.7179
71850250|NCT02978183|143213920|SUPERIORITY|||||||0.7262||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 25 Minutes Post-CAC||||0.7262
71850251|NCT02978183|143213920|SUPERIORITY|||||||0.8275||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: 30 Minutes Post-CAC||||0.8275
71850252|NCT02978183|143213920|SUPERIORITY|||||||0.618||||||Adjustments for multiplicity were not employed|ANCOVA|||Day 8: All Post-CAC Time Points||||0.6180
71850253|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity were not employed|Fisher Exact|||Day 7: 10 minutes post-CAC||||>0.9999
71850254|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 15 minutes post-CAC||||>0.9999
71850255|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 20 minutes post-CAC||||>0.9999
71818269|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.83|1.01|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 5 antibody at Day 42.||1.01|0.83|
71818270|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|1.01|||||TWO_SIDED|95.0|0.92|1.11|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6A antibody at Day 42.||1.11|0.92|
71818271|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.98|||||TWO_SIDED|95.0|0.89|1.09|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 6B antibody at Day 42.||1.09|0.89|
71818272|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||TWO_SIDED|95.0|0.86|1.03|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 7F antibody at Day 42.||1.03|0.86|
71818273|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||TWO_SIDED|95.0|0.9|1.08|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 9V antibody at Day 42.||1.08|0.90|
71818274|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.81|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 14 antibody at Day 42.||1.02|0.81|
71818275|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||TWO_SIDED|95.0|0.84|1.02|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 18C antibody at Day 42.||1.02|0.84|
71818276|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.97|||||TWO_SIDED|95.0|0.87|1.07|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19A antibody at Day 42.||1.07|0.87|
71818277|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.96|||||TWO_SIDED|95.0|0.87|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 19F antibody at Day 42.||1.06|0.87|
71818278|NCT01702428|143139809|NON_INFERIORITY|The LL of the 2-sided 95% CI for GMC ratio (INV\_MMR Group over COM\_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.95|||||TWO_SIDED|95.0|0.85|1.06|||ANCOVA|95% CI for GMC ratio (INV\_MMR Group over the COM\_MMR Group) was computed using an ANCOVA model: Adjustment for baseline concentration-pooled variance.||In US sub-cohort: Adjusted GMC ratio (INV\_MMR Group divided by COM\_MMR Group) for anti-PnPS 23F antibody at Day 42.||1.06|0.85|
71850256|NCT02978183|143213921|SUPERIORITY|||||||0.7312||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 25 minutes post-CAC||||0.7312
71818279|NCT01586338|143139865|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance = 0.05.|Paired t-test|||||||<0.0001
71818280|NCT01586338|143139865|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Sign Rank Test|||||||<0.0001
71818281|NCT01544491|143139928|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|5.25||0.9712|TWO_SIDED|80.0|-6.6|6.8|||Log Rank|||at 12 months||6.8|-6.6|0.9712
71818282|NCT01544491|143139928|NON_INFERIORITY|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|5.84||0.9634|TWO_SIDED|80.0|-7.3|7.7|||Log Rank|||36 months||7.7|-7.3|0.9634
71818283|NCT01544491|143139929|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|5.26||0.3455|TWO_SIDED|80.0|-1.8|11.8|||t-test, 2 sided|||at 12 months||11.8|-1.8|0.3455
71850257|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 7: 30 minutes post-CAC||||>0.9999
71850258|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 10 minutes post-CAC||||>0.9999
71850259|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 15 minutes post-CAC||||>0.9999
71679510|NCT02612610|142877072|OTHER||LS Mean Difference|-0.52||||0.0003|TWO_SIDED|95.0|-0.8|-0.24|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.24|-0.80|0.0003
71850260|NCT02978183|143213921|SUPERIORITY||||||>|0.9999||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 20 minutes post-CAC||||>0.9999
71900698|NCT02137772|143323006|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.4||||0.4056|TWO_SIDED|95.0|-4.0|3.2||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||3.2|-4.0|0.4056
71900699|NCT02137772|143323007|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-1.0||||0.2258|TWO_SIDED|95.0|-3.5|1.5||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||1.5|-3.5|0.2258
71900700|NCT02137772|143323008|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-31.0|||<|0.0001|TWO_SIDED|95.0|-39.6|-22.4||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-22.4|-39.6|<0.0001
71900701|NCT02137772|143323009|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-23.3|||<|0.0001|TWO_SIDED|95.0|-32.3|-14.3||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||-14.3|-32.3|<0.0001
71900702|NCT02137772|143323010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)||||||<0.0001
71818284|NCT01544491|143139929|NON_INFERIORITY|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood's formula.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.95||0.8642|TWO_SIDED|80.0|-5.5|7.2|||t-test, 2 sided|||36 months||7.2|-5.5|0.8642
71818285|NCT00680056|143139974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|56.0|STANDARD_DEVIATION|60.0||0.038||95.0|||||t-test, 2 sided||Mean difference= Formoterol plus Tiotropium minus Formoterol plus Placebo(Tiotropium)|It was calculated a total sample size of a 2x2 cross-over design as 24 for a two-sided t-test achieves 85% power to infer that the mean difference is not zero, the actual mean difference is 20, the standard deviation of the differences is 15, and the significance level is 0.05||||0.038
71818286|NCT00680056|143139975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.88|STANDARD_DEVIATION|2.39||0.054||95.0|||||t-test, 2 sided||Mean difference=Arm 2 minus Arm 1|||||0.054
71850261|NCT02978183|143213921|SUPERIORITY|||||||0.4297||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 25 minutes post-CAC||||0.4297
71900703|NCT00418262|143323019|SUPERIORITY||Mean Difference (Net)|0.05|||||TWO_SIDED|95.0|-0.21|0.3|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.30|-0.21|
71900704|NCT00418262|143323019|SUPERIORITY||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.42|0.6|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.60|-0.42|
71818287|NCT02733042|143139976|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.|||
71818288|NCT02733042|143139976|OTHER|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².|||
71818289|NCT00337662|143140003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Between-group p-values for each baseline to post-baseline visit were the same, p\<0.001.|Mixed Effects Model Repeated Measures|||||||<0.001
71818290|NCT00337662|143140004|SUPERIORITY_OR_OTHER|||||||0.266||95.0||||Change from Week 2 to Week 3 p-value|Mixed-Effects Model Repeated-Measures|||||||0.266
71818291|NCT00337662|143140004|SUPERIORITY_OR_OTHER|||||||0.884||95.0||||Change from Week 2 to Week 4 p-value|Mixed-Effects Model Repeated-Measures|||||||0.884
71850262|NCT02978183|143213921|SUPERIORITY|||||||0.4791||||||Adjustments for multiplicity will not be employed|Fisher Exact|||Day 8: 30 minutes post-CAC||||0.4791
71850263|NCT02102724|143213933|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen's d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.|The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.|||< 0.05
71850264|NCT02429115|143213945|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71850265|NCT02429115|143213946|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71850266|NCT02429115|143213947|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71850267|NCT01450397|143213951|SUPERIORITY_OR_OTHER||||||<|0.0013|||||||t-test, 2 sided|||||||<0.0013
71900705|NCT00418262|143323020|SUPERIORITY||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.11|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.11|
71900706|NCT00418262|143323020|SUPERIORITY||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.23|0.77|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.77|-0.23|
71900707|NCT00418262|143323021|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
71900708|NCT00418262|143323021|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.36|-0.17|
71900709|NCT00418262|143323022|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
71900710|NCT00418262|143323022|SUPERIORITY||Mean Difference (Net)|0.13|||||TWO_SIDED|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.40|-0.16|
71900711|NCT00418262|143323023|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
71900712|NCT00418262|143323023|SUPERIORITY||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.18|-0.36|
71900713|NCT00418262|143323024|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
71900714|NCT00418262|143323024|SUPERIORITY||Mean Difference (Net)|0.04|||||TWO_SIDED|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.20|
71818292|NCT00337662|143140004|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Change from Week 2 to Week 6 p-value|Mixed-Effects Model Repeated-Measures|||||||0.151
71850268|NCT00912964|143213952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.005|TWO_SIDED|95.0|-0.74|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.06|-0.74|0.005
71850269|NCT00912964|143213952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|95.0|-0.76|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.76|0.001
71679511|NCT02612610|142877073|OTHER||LS Mean Difference|-0.4||||0.0099|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.10|-0.71|0.0099
71679512|NCT02612610|142877073|OTHER||LS Mean Difference|-0.28||||0.0695|TWO_SIDED|95.0|-0.58|0.02|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.02|-0.58|0.0695
71679513|NCT02612610|142877073|OTHER||LS Mean Difference|-0.62||||0.0001|TWO_SIDED|95.0|-0.93|-0.31|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.31|-0.93|0.0001
71818293|NCT00337662|143140004|SUPERIORITY_OR_OTHER|||||||0.216||95.0||||Change from Week 2 to Week 8 p-value|Mixed-Effects Model Repeated-Measures|||||||0.216
71818294|NCT00337662|143140004|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Change from Week 2 to Week 12 p-value|Mixed-Effects Model Repeated-Measures|||||||0.020
71850270|NCT00912964|143213953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.15|TWO_SIDED|95.0|-1.6|10.8||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||10.8|-1.6|0.15
71850271|NCT00912964|143213953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.4|||<|0.001|TWO_SIDED|95.0|6.3|18.6||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||18.6|6.3|<0.001
71679514|NCT02612610|142877074|OTHER||LS Mean Difference|-0.24||||0.0991|TWO_SIDED|95.0|-0.52|0.04|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.04|-0.52|0.0991
71818295|NCT00337662|143140005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71818296|NCT00337662|143140006|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||Fisher Exact|||||||0.604
71818297|NCT00337662|143140007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71818298|NCT00337662|143140008|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||Fisher Exact|||||||0.745
71818299|NCT00337662|143140009|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||||||0.474
71818300|NCT00337662|143140010|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.034
71818301|NCT00337662|143140010|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.125
71818302|NCT00337662|143140011|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||All comparisons between EO-RIS and NEO-RIS and between NEO-RIS and NEO-OLZ had p-values greater than 0.05.|Fisher Exact|||||||>0.05
71679515|NCT02612610|142877074|OTHER||LS Mean Difference|-0.25||||0.0811|TWO_SIDED|95.0|-0.53|0.03|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.03|-0.53|0.0811
71818303|NCT00337662|143140012|SUPERIORITY_OR_OTHER|||||||0.355||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.355
71818304|NCT00337662|143140012|SUPERIORITY_OR_OTHER|||||||0.244||95.0|||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.||||||0.244
71818305|NCT00337662|143140013|SUPERIORITY_OR_OTHER|||||||0.998||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.998
71818306|NCT00337662|143140013|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.505
71818307|NCT00337662|143140014|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.266
71818308|NCT00337662|143140014|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.||||||0.015
71818309|NCT00337662|143140015|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.140
71818310|NCT00337662|143140015|SUPERIORITY_OR_OTHER|||||||0.181||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.181
71818311|NCT00337662|143140016|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.254
71818312|NCT00337662|143140016|SUPERIORITY_OR_OTHER|||||||0.299||95.0|||||ANOVA|P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.||||||0.299
71818313|NCT00337662|143140017|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.291
71818314|NCT00337662|143140017|SUPERIORITY_OR_OTHER|||||||0.259||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.259
71818315|NCT00337662|143140018|SUPERIORITY_OR_OTHER|||||||0.209||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.209
71818316|NCT00337662|143140018|SUPERIORITY_OR_OTHER|||||||0.411||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.411
71818317|NCT00337662|143140019|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.544
71818318|NCT00337662|143140019|SUPERIORITY_OR_OTHER|||||||0.386||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.386
71818319|NCT00337662|143140020|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.026
71818320|NCT00337662|143140020|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA|||||||0.143
71818321|NCT03691948|143140025|SUPERIORITY|||||||0.531|||||||ANOVA|||||||.531
71818322|NCT03691948|143140026|SUPERIORITY|||||||0.076|||||||ANOVA|||||||0.076
71818323|NCT00180713|143140070|SUPERIORITY|||||||0.028|||||||ANOVA|||||||0.028
71818324|NCT00180713|143140071|SUPERIORITY|||||||0.86|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.86
71818325|NCT00180713|143140072|SUPERIORITY|||||||0.4|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.||||0.4
71818326|NCT00180713|143140073|SUPERIORITY|||||||0.041|||||||ANOVA|||||||0.041
71818327|NCT00180713|143140074|SUPERIORITY|||||||0.26|||||||ANOVA|||||||0.26
71818328|NCT00610701|143140078|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71818329|NCT01152294|143140079|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.6|STANDARD_DEVIATION|2.4||0.01|TWO_SIDED|95.0|1.02|7.96|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.||7.96|1.02|0.01
71818330|NCT04424290|143140175|OTHER||Adjusted mean difference|-0.0234|STANDARD_ERROR_OF_MEAN|0.0157|||TWO_SIDED|95.0|-0.0558|0.0089|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0089|-0.0558|
71818331|NCT04424290|143140176|OTHER||Adjusted mean difference|0.0215|STANDARD_ERROR_OF_MEAN|0.0429|||TWO_SIDED|95.0|-0.067|0.11|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1100|-0.0670|
71818332|NCT04424290|143140177|OTHER||Adjusted mean difference|-0.0109|STANDARD_ERROR_OF_MEAN|0.0145|||TWO_SIDED|95.0|-0.0412|0.0195|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.0195|-0.0412|
71818333|NCT04424290|143140178|OTHER||Adjusted mean difference|-0.0228|STANDARD_ERROR_OF_MEAN|0.0603|||TWO_SIDED|95.0|-0.1477|0.1021|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||0.1021|-0.1477|
71818334|NCT04424290|143140179|OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-8.1|5.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.5|-8.1|
71818335|NCT04424290|143140180|OTHER||Adjusted mean difference|4.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.3|16.2|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.2|-7.3|
71818336|NCT04424290|143140181|OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.6|3.0|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.0|-9.6|
71818337|NCT04424290|143140182|OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.3|6.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||6.1|-7.3|
71818338|NCT04424290|143140183|OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-8.7|3.1|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||3.1|-8.7|
71818339|NCT04424290|143140184|OTHER||Adjusted mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-4.9|5.4|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||5.4|-4.9|
71818340|NCT04424290|143140185|OTHER||Adjusted mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-2.7|7.9|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||7.9|-2.7|
71818341|NCT04424290|143140186|OTHER||Adjusted mean difference|7.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-1.2|16.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||16.5|-1.2|
71850272|NCT00912964|143213954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47||||0.007|TWO_SIDED|95.0|-0.82|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.13|-0.82|0.007
71818342|NCT04424290|143140187|OTHER||Adjusted mean difference|13.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-2.3|29.8|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||29.8|-2.3|
71818343|NCT04424290|143140188|OTHER||Adjusted mean difference|6.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-0.9|14.5|||||Difference calculated as \[BI\]-\[Sham\].|The Mixed model with repeated measurements (MMRM) model included the fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.||14.5|-0.9|
71818344|NCT04249336|143140199|SUPERIORITY||Mean Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
71818345|NCT04249336|143140199|SUPERIORITY||Mean Difference (Net)|33.0|||<|0.05|TWO_SIDED|95.0||||Threshold P\<0.05|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
71818346|NCT04249336|143140199|SUPERIORITY||Mean Difference (Net)|23.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
71818347|NCT04249336|143140200|SUPERIORITY||Mean Difference (Net)|32.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
71850273|NCT00912964|143213954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.42||||0.015|TWO_SIDED|95.0|-0.76|-0.08||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.08|-0.76|0.015
71818348|NCT04249336|143140200|SUPERIORITY||Mean Difference (Net)|39.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
71818349|NCT04249336|143140200|SUPERIORITY||Mean Difference (Net)|30.0|||<|0.05|TWO_SIDED|||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
71818350|NCT04249336|143140201|SUPERIORITY||Median Difference (Net)|36.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANCOVA||Treatment difference in percent = BioMin F- Colgate Total|It was calculated that 140 participants randomized in a 1:1:1:1 fashion between the four arms would have at least 80 % power to detect a difference of 0.20 mean scores between four treatments from baseline to week 4. Sample size was determined using PAS V.11, two independent sample t-test with 95% confidence interval.||||<0.05
71818351|NCT04249336|143140201|SUPERIORITY||Mean Difference (Net)|28.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Colgate Sensitive Pro relief - Colgate Total|||||<0.05
71818352|NCT04249336|143140201|SUPERIORITY||Mean Difference (Net)|25.0|||<|0.05|TWO_SIDED|95.0||||Threshold for statistical significance was p \<0.05.|ANOVA||Treatment difference in percent = Sensodyne Rapid Action - Colgate Total|||||<0.05
71818353|NCT01987596|143140210|SUPERIORITY|||||||1|||||||McNemar|||||||1.00
71818354|NCT01987596|143140211|SUPERIORITY||||||<|0.0001|||||||ANOVA|||two-period crossover design analysis||||<0.0001
71818355|NCT01987596|143140212|SUPERIORITY||||||<|0.0001|||||||ANOVA|||2 treatment, 2 periiod cross-over analysis||||<0.0001
71818356|NCT00574990|143140230|SUPERIORITY_OR_OTHER||chi square|12.99|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|||||Differences between roles and communication event content were assessed by Chi squared|Chi-squared|||Descriptive counts and chi squared were done on the observation data.||||0.01
71818357|NCT01355419|143140234|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.||||<0.05
71818358|NCT01355419|143140235|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|Regression, Linear|||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.||||<0.05
71818359|NCT00179010|143140237|SUPERIORITY_OR_OTHER|||||||0.854|||||||ANOVA|||||||0.854
71818360|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97|STANDARD_ERROR_OF_MEAN|5.596|||TWO_SIDED|95.0|-12.68|10.75|||||Comparison of SBP Day 1.|||10.75|-12.68|
71818361|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1|STANDARD_ERROR_OF_MEAN|4.215|||TWO_SIDED|95.0|-12.92|4.72|||||Comparison of SBP Day 7.|||4.72|-12.92|
71818362|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.21|STANDARD_ERROR_OF_MEAN|5.727|||TWO_SIDED|95.0|-5.78|18.19|||||Comparison of SBP Day 1.|||18.19|-5.78|
71818363|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.76|STANDARD_ERROR_OF_MEAN|4.314|||TWO_SIDED|95.0|-13.79|4.27|||||Comparison of SBP Day 7.|||4.27|-13.79|
71818364|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.138|||TWO_SIDED|95.0|-3.89|5.06|||||Comparison of DBP Day 1.|||5.06|-3.89|
71818365|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.64|STANDARD_ERROR_OF_MEAN|2.382|||TWO_SIDED|95.0|-11.62|-1.65|||||Comparison of DBP Day 7.|||-1.65|-11.62|
71818366|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.248|||TWO_SIDED|95.0|-3.73|5.68|||||Comparison of DBP Day 1.|||5.68|-3.73|
71818367|NCT00453479|143140275|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.81|STANDARD_ERROR_OF_MEAN|2.504|||TWO_SIDED|95.0|-16.05|-5.57|||||Comparison of DBP Day 7.|||-5.57|-16.05|
71818368|NCT00453479|143140276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.26|STANDARD_ERROR_OF_MEAN|3.745|||TWO_SIDED|95.0|-5.58|10.1|||||Comparison at Day 1.|||10.10|-5.58|
71818369|NCT00453479|143140276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.62|STANDARD_ERROR_OF_MEAN|3.785|||TWO_SIDED|95.0|-5.3|10.54|||||Comparison at Day 7.|||10.54|-5.30|
71818370|NCT00453479|143140276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|3.979|||TWO_SIDED|95.0|-8.17|8.48|||||Comparison at Day 1.|||8.48|-8.17|
71818371|NCT00453479|143140276|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.44|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|-13.86|2.97|||||Comparison at Day 7.|||2.97|-13.86|
71818372|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.78|STANDARD_ERROR_OF_MEAN|4.611|||TWO_SIDED|95.0|-12.43|6.87|||||Comparison of SBP Day 1.|||6.87|-12.43|
71818373|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|3.913|||TWO_SIDED|95.0|-10.07|6.31|||||Comparison of SBP Day 7.|||6.31|-10.07|
71818374|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.01|STANDARD_ERROR_OF_MEAN|4.718|||TWO_SIDED|95.0|-6.87|12.88|||||Comparison of SBP Day 1.|||12.88|-6.87|
71818375|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|4.005|||TWO_SIDED|95.0|-11.88|4.89|||||Comparison of SBP Day 7.|||4.89|-11.88|
71818376|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.822|||TWO_SIDED|95.0|-4.09|3.54|||||Comparison of DBP Day 1.|||3.54|-4.09|
71818377|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.89|STANDARD_ERROR_OF_MEAN|2.116|||TWO_SIDED|95.0|-8.32|0.54|||||Comparison of DBP Day 7.|||0.54|-8.32|
71818378|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|1.916|||TWO_SIDED|95.0|-5.76|2.26|||||Comparison of DBP Day 1.|||2.26|-5.76|
71818379|NCT00453479|143140277|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.39|STANDARD_ERROR_OF_MEAN|2.224|||TWO_SIDED|95.0|-14.04|-4.73|||||Comparison of DBP Day 7.|||-4.73|-14.04|
71850274|NCT00912964|143213955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.34||||0.039|TWO_SIDED|95.0|-0.68|-0.01||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.01|-0.68|0.039
71818380|NCT00453479|143140278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.52|5.79|||||Comparison at Day 1.|||5.79|-5.52|
71818381|NCT00453479|143140278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|2.813|||TWO_SIDED|95.0|-3.5|8.28|||||Comparison at Day 7.|||8.28|-3.50|
71818382|NCT00453479|143140278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67|STANDARD_ERROR_OF_MEAN|2.869|||TWO_SIDED|95.0|-8.67|3.34|||||Comparison at Day 1.|||3.34|-8.67|
71818383|NCT00453479|143140278|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.84|STANDARD_ERROR_OF_MEAN|2.989|||TWO_SIDED|95.0|-10.1|2.41|||||Comparison at Day 7.|||2.41|-10.10|
71818384|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.42|STANDARD_ERROR_OF_MEAN|8.157|||TWO_SIDED|95.0|-12.66|21.49|||||Comparison of QTcB Day 1.|||21.49|-12.66|
71818385|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.02|STANDARD_ERROR_OF_MEAN|6.76|||TWO_SIDED|95.0|-5.13|23.17|||||Comparison of QTcB Day 7.|||23.17|-5.13|
71818386|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.57|STANDARD_ERROR_OF_MEAN|8.51|||TWO_SIDED|95.0|-7.24|28.38|||||Comparison of QTcB Day 1.|||28.38|-7.24|
71818387|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.5|STANDARD_ERROR_OF_MEAN|7.052|||TWO_SIDED|95.0|1.74|31.26|||||Comparison of QTcB Day 7.|||31.26|1.74|
71818388|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|STANDARD_ERROR_OF_MEAN|8.908|||TWO_SIDED|95.0|-16.51|20.78|||||Comparison of QTcF Day 1.|||20.78|-16.51|
71818389|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.29|STANDARD_ERROR_OF_MEAN|5.298|||TWO_SIDED|95.0|1.2|23.38|||||Comparison of QTcF Day 7.|||23.38|1.20|
71818390|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|17.66|STANDARD_ERROR_OF_MEAN|9.171|||TWO_SIDED|95.0|-1.53|36.85|||||Comparison of QTcF Day 1.|||36.85|-1.53|
71818391|NCT00453479|143140280|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.32|STANDARD_ERROR_OF_MEAN|5.454|||TWO_SIDED|95.0|10.9|33.73|||||Comparison of QTcF Day 7.|||33.73|10.90|
71818392|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.55|STANDARD_ERROR_OF_MEAN|5.262|||TWO_SIDED|95.0|-1.46|20.57|||||Comparison of QTcB Day 1.|||20.57|-1.46|
71818393|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|5.902|||TWO_SIDED|95.0|-3.97|20.74|||||Comparison of QTcB Day 7.|||20.74|-3.97|
71818394|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.47|STANDARD_ERROR_OF_MEAN|5.49|||TWO_SIDED|95.0|-0.02|22.96|||||Comparison of QTcB Day 1.|||22.96|-0.02|
71818395|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.28|STANDARD_ERROR_OF_MEAN|6.157|||TWO_SIDED|95.0|2.39|28.17|||||Comparison of QTcB Day 7.|||28.17|2.39|
71850275|NCT00912964|143213955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.85|-0.17||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.17|-0.85|<0.001
71850276|NCT00912964|143213956|SUPERIORITY_OR_OTHER_LEGACY||LS Difference|-0.18||||0.3|TWO_SIDED|95.0|-0.53|0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.16|-0.53|0.30
71818396|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.32|STANDARD_ERROR_OF_MEAN|4.622|||TWO_SIDED|95.0|-1.35|18.0|||||Comparison of QTcF Day 1.|||18.00|-1.35|
71818397|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.239|||TWO_SIDED|95.0|-2.21|19.72|||||Comparison of QTcF Day 7.|||19.72|-2.21|
71818398|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.83|STANDARD_ERROR_OF_MEAN|4.759|||TWO_SIDED|95.0|6.87|26.79|||||Comparison of QTcF Day 1.|||26.79|6.87|
71818399|NCT00453479|143140281|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.46|STANDARD_ERROR_OF_MEAN|5.394|||TWO_SIDED|95.0|9.17|31.75|||||Comparison of QTcF Day 7.|||31.75|9.17|
71818400|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.0921|||TWO_SIDED|95.0|-0.035|0.328|||||Comparison of FEV1, Day 1, 1 hour|||0.328|-0.035|
71818401|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.171|STANDARD_ERROR_OF_MEAN|0.0944|||TWO_SIDED|95.0|-0.015|0.357|||||Comparison of FEV1, Day 1, 2 hour|||0.357|-0.015|
71850277|NCT00912964|143213956|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.37||||0.035|TWO_SIDED|95.0|-0.71|-0.03||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.03|-0.71|0.035
71679516|NCT02612610|142877074|OTHER||LS Mean Difference|-0.47||||0.0014|TWO_SIDED|95.0|-0.76|-0.19|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.19|-0.76|0.0014
71679517|NCT02612610|142877075|OTHER||LS Mean Difference|-0.21||||0.1468|TWO_SIDED|95.0|-0.5|0.07|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. ."||0.07|-0.50|0.1468
71679518|NCT02612610|142877075|OTHER||LS Mean Difference|-0.08||||0.5874|TWO_SIDED|95.0|-0.36|0.2|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.20|-0.36|0.5874
71679519|NCT02612610|142877075|OTHER||LS Mean Difference|-0.49||||0.0008|TWO_SIDED|95.0|-0.78|-0.21|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.21|-0.78|0.0008
71679520|NCT02612610|142877076|OTHER||Mixed Effect Repeated Measures model|-0.39||||0.0177|TWO_SIDED|95.0|-0.7|-0.07|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.07|-0.70|0.0177
71679521|NCT02612610|142877076|OTHER||LS Mean Difference|-0.32||||0.0498|TWO_SIDED|95.0|-0.63|0.0|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.00|-0.63|0.0498
71679522|NCT02612610|142877076|OTHER||LS Mean Difference|-0.59||||0.0004|TWO_SIDED|95.0|-0.92|-0.27|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||-0.27|-0.92|0.0004
71679523|NCT02612610|142877078|OTHER||LS Mean Difference|-6.4||||0.1318|TWO_SIDED|95.0|-14.8|1.9|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-14.8|0.1318
71679524|NCT02612610|142877078|OTHER||LS Mean Difference|-2.9||||0.4917|TWO_SIDED|95.0|-11.3|5.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.4|-11.3|0.4917
71900715|NCT00418262|143323025|SUPERIORITY||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.24|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.24|
71818402|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|95.0|-0.107|0.228|||||Comparison of FEV1, Day 1, 4 hour|||0.228|-0.107|
71818403|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1195|||TWO_SIDED|95.0|-0.085|0.386|||||Comparison of FEV1, Day 1, 9 hour|||0.386|-0.085|
71818404|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.124|STANDARD_ERROR_OF_MEAN|0.1107|||TWO_SIDED|95.0|-0.094|0.343|||||Comparison of FEV1, Day 1, 12 hour|||0.343|-0.094|
71818405|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.163|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.077|0.404|||||Comparison of FEV1, Day 1, 24 hour|||0.404|-0.077|
71818406|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.236|STANDARD_ERROR_OF_MEAN|0.1057|||TWO_SIDED|95.0|0.027|0.444|||||Comparison of FEV1, Day 7, Baseline|||0.444|0.027|
71818407|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.229|STANDARD_ERROR_OF_MEAN|0.1292|||TWO_SIDED|95.0|-0.026|0.483|||||Comparison of FEV1, Day 7, 1 hour|||0.483|-0.026|
71818408|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.095|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.163|0.353|||||Comparison of FEV1, Day 7, 2 hour|||0.353|-0.163|
71818409|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.173|STANDARD_ERROR_OF_MEAN|0.1243|||TWO_SIDED|95.0|-0.072|0.418|||||Comparison of FEV1, Day 7, 4 hour|||0.418|-0.072|
71818410|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.205|STANDARD_ERROR_OF_MEAN|0.1499|||TWO_SIDED|95.0|-0.09|0.501|||||Comparison of FEV1, Day 7, 9 hour|||0.501|-0.090|
71818411|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.143|||TWO_SIDED|95.0|-0.062|0.502|||||Comparison of FEV1, Day 7, 12 hour|||0.502|-0.062|
71818412|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|95.0|-0.093|0.506|||||Comparison of FEV1, Day 7, 24 hour|||0.506|-0.093|
71818413|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.206|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|0.015|0.397|||||Comparison of FEV1, Day 1, 1 hour|||0.397|0.015|
71818414|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.329|STANDARD_ERROR_OF_MEAN|0.0994|||TWO_SIDED|95.0|0.133|0.525|||||Comparison of FEV1, Day 1, 2 hour|||0.525|0.133|
71818415|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.0895|||TWO_SIDED|95.0|0.09|0.443|||||Comparison of FEV1, Day 1, 4 hour|||0.443|0.090|
71818416|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.1258|||TWO_SIDED|95.0|0.072|0.568|||||Comparison of FEV1, Day 1, 9 hour|||0.568|0.072|
71818417|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.172|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|95.0|-0.058|0.402|||||Comparison of FEV1, Day 1, 12 hour|||0.402|-0.058|
71818418|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.154|STANDARD_ERROR_OF_MEAN|0.1285|||TWO_SIDED|95.0|-0.099|0.407|||||Comparison of FEV1, Day 1, 24 hour|||0.407|-0.099|
71818419|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.256|STANDARD_ERROR_OF_MEAN|0.1113|||TWO_SIDED|95.0|0.036|0.475|||||Comparison of FEV1, Day 7, Baseline|||0.475|0.036|
71818420|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.296|STANDARD_ERROR_OF_MEAN|0.1361|||TWO_SIDED|95.0|0.027|0.564|||||Comparison of FEV1, Day 7, 1 hour|||0.564|0.027|
71818421|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.202|STANDARD_ERROR_OF_MEAN|0.1378|||TWO_SIDED|95.0|-0.069|0.474|||||Comparison of FEV1, Day 7, 2 hour|||0.474|-0.069|
71818422|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.207|STANDARD_ERROR_OF_MEAN|0.1309|||TWO_SIDED|95.0|-0.051|0.465|||||Comparison of FEV1, Day 7, 4 hour|||0.465|-0.051|
71850278|NCT00912964|143213957|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.07||||0.083|TWO_SIDED|95.0|-0.15|0.01||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.01|-0.15|0.083
71818423|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.1579|||TWO_SIDED|95.0|-0.032|0.591|||||Comparison of FEV1, Day 7, 9 hour|||0.591|-0.032|
71818424|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.1506|||TWO_SIDED|95.0|-0.104|0.49|||||Comparison of FEV1, Day 7, 12 hour|||0.490|-0.104|
71818425|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.1601|||TWO_SIDED|95.0|-0.136|0.495|||||Comparison of FEV1, Day 7, 24 hour|||0.495|-0.136|
71818426|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.137|STANDARD_ERROR_OF_MEAN|0.2029|||TWO_SIDED|95.0|-0.263|0.537|||||Comparison of FVC, Day 1, 1 hour|||0.537|-0.263|
71818427|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.1965|||TWO_SIDED|95.0|-0.257|0.518|||||Comparison of FVC, Day 1, 2 hour|||0.518|-0.257|
71818428|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.038|STANDARD_ERROR_OF_MEAN|0.1908|||TWO_SIDED|95.0|-0.414|0.338|||||Comparison of FVC, Day 1, 4 hour|||0.338|-0.414|
71818429|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2013|||TWO_SIDED|95.0|-0.337|0.457|||||Comparison of FVC, Day 1, 9 hour|||0.457|-0.337|
71818430|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.2322|||TWO_SIDED|95.0|-0.343|0.572|||||Comparison of FVC, Day 1, 12 hour|||0.572|-0.343|
71818431|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.115|STANDARD_ERROR_OF_MEAN|0.1988|||TWO_SIDED|95.0|-0.277|0.507|||||Comparison of FVC, Day 1, 24 hour|||0.507|-0.277|
71818432|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.362|STANDARD_ERROR_OF_MEAN|0.2801|||TWO_SIDED|95.0|-0.19|0.914|||||Comparison of FVC, Day 7, Baseline|||0.914|-0.190|
71818433|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.269|STANDARD_ERROR_OF_MEAN|0.2696|||TWO_SIDED|95.0|-0.263|0.8|||||Comparison of FVC, Day 7, 1 hour|||0.800|-0.263|
71818434|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.2648|||TWO_SIDED|95.0|-0.501|0.543|||||Comparison of FVC, Day 7, 2 hour|||0.543|-0.501|
71818435|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.177|STANDARD_ERROR_OF_MEAN|0.2606|||TWO_SIDED|95.0|-0.337|0.691|||||Comparison of FVC, Day 7, 4 hour|||0.691|-0.337|
71818436|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.266|STANDARD_ERROR_OF_MEAN|0.2684|||TWO_SIDED|95.0|-0.263|0.795|||||Comparison of FVC, Day 7, 9 hour|||0.795|-0.263|
71818437|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.367|STANDARD_ERROR_OF_MEAN|0.2923|||TWO_SIDED|95.0|-0.209|0.943|||||Comparison of FVC, Day 7, 12 hour|||0.943|-0.209|
71818438|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.242|STANDARD_ERROR_OF_MEAN|0.2665|||TWO_SIDED|95.0|-0.283|0.768|||||Comparison of FVC, Day 7, 24 hour|||0.768|-0.283|
71818439|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.2106|||TWO_SIDED|95.0|-0.263|0.567|||||Comparison of FVC, Day 1, 1 hour|||0.567|-0.263|
71818440|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.321|STANDARD_ERROR_OF_MEAN|0.2039|||TWO_SIDED|95.0|-0.081|0.723|||||Comparison of FVC, Day 1, 2 hour|||0.723|-0.081|
71818441|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.311|STANDARD_ERROR_OF_MEAN|0.1981|||TWO_SIDED|95.0|-0.079|0.701|||||Comparison of FVC, Day 1, 4 hour|||0.701|-0.079|
71818442|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|95.0|-0.064|0.76|||||Comparison of FVC, Day 1, 9 hour|||0.760|-0.064|
71679525|NCT02612610|142877078|OTHER||LS Mean Difference|-9.8||||0.0228|TWO_SIDED|95.0|-18.2|-1.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.4|-18.2|0.0228
71679526|NCT02612610|142877079|OTHER||LS Mean Difference|-2.6||||0.554|TWO_SIDED|95.0|-11.5|6.2|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||6.2|-11.5|0.5540
71818443|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.245|STANDARD_ERROR_OF_MEAN|0.241|||TWO_SIDED|95.0|-0.23|0.72|||||Comparison of FVC, Day 1, 12 hour|||0.720|-0.230|
71679527|NCT02612610|142877079|OTHER||LS Mean Difference|-3.2||||0.4702|TWO_SIDED|95.0|-12.0|5.6|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||5.6|-12.0|0.4702
71818444|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.162|STANDARD_ERROR_OF_MEAN|0.2063|||TWO_SIDED|95.0|-0.245|0.569|||||Comparison of FVC, Day 1, 24 hour|||0.569|-0.245|
71818445|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.535|STANDARD_ERROR_OF_MEAN|0.2907|||TWO_SIDED|95.0|-0.038|1.108|||||Comparison of FVC, Day 7, Baseline|||1.108|-0.038|
71818446|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.623|STANDARD_ERROR_OF_MEAN|0.2798|||TWO_SIDED|95.0|0.072|1.175|||||Comparison of FVC, Day 7, 1 hour|||1.175|0.072|
71818447|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.459|STANDARD_ERROR_OF_MEAN|0.2748|||TWO_SIDED|95.0|-0.083|1.0|||||Comparison of FVC, Day 7, 2 hour|||1.000|-0.083|
71900716|NCT00418262|143323025|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.49|0.49|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.49|-0.49|
71818448|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.464|STANDARD_ERROR_OF_MEAN|0.2705|||TWO_SIDED|95.0|-0.069|0.997|||||Comparison of FVC, Day 7, 4 hour|||0.997|-0.069|
71818449|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.445|STANDARD_ERROR_OF_MEAN|0.2786|||TWO_SIDED|95.0|-0.104|0.994|||||Comparison of FVC, Day 7, 9 hour|||0.994|-0.104|
71818450|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.284|STANDARD_ERROR_OF_MEAN|0.3034|||TWO_SIDED|95.0|-0.314|0.882|||||Comparison of FVC, Day 7, 12 hour|||0.882|-0.314|
71818451|NCT00453479|143140282|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.384|STANDARD_ERROR_OF_MEAN|0.2766|||TWO_SIDED|95.0|-0.162|0.929|||||Comparison of FVC, Day 7, 24 hour|||0.929|-0.162|
71818452|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.233|STANDARD_ERROR_OF_MEAN|3.3333|||TWO_SIDED|95.0|-4.743|9.21|||||Comparison of maximum heart rate Day 1.|||9.210|-4.743|
71818453|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.73|STANDARD_ERROR_OF_MEAN|8.0907|||TWO_SIDED|95.0|-11.2|22.664|||||Comparison of maximum heart rate Day 7.|||22.664|-11.200|
71818454|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.272|STANDARD_ERROR_OF_MEAN|3.239|||TWO_SIDED|95.0|-8.051|5.507|||||Comparison of maximum heart rate Day 1.|||5.507|-8.051|
71818455|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.988|STANDARD_ERROR_OF_MEAN|7.8616|||TWO_SIDED|95.0|-15.47|17.443|||||Comparison of maximum heart rate Day 7.|||17.443|-15.470|
71818456|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.734|STANDARD_ERROR_OF_MEAN|3.441|||TWO_SIDED|95.0|-4.468|9.936|||||Comparison of mean heart rate Day 1.|||9.936|-4.468|
71818457|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.783|STANDARD_ERROR_OF_MEAN|2.9409|||TWO_SIDED|95.0|-1.372|10.938|||||Comparison of mean heart rate Day 7.|||10.938|-1.372|
71818458|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.074|STANDARD_ERROR_OF_MEAN|3.3103|||TWO_SIDED|95.0|-8.003|5.854|||||Comparison of mean heart rate Day 1.|||5.854|-8.003|
71818459|NCT00453479|143140287|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.569|STANDARD_ERROR_OF_MEAN|2.8291|||TWO_SIDED|95.0|-4.353|7.49|||||Comparison of mean heart rate Day 7.|||7.490|-4.353|
71818460|NCT00453479|143140291|SUPERIORITY_OR_OTHER||Ratio|1.139|STANDARD_ERROR_OF_MEAN|0.1939|||TWO_SIDED|90.0|0.811|1.601|||||SE logs is presented as standard error of mean. Comparison of GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.601|0.811|
71818461|NCT00453479|143140291|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.2057|||TWO_SIDED|90.0|0.739|1.52|||||SE logs is presented as standard error of mean. Comparison of GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.520|0.739|
71818462|NCT00453479|143140292|SUPERIORITY_OR_OTHER||Ratio|1.408|STANDARD_ERROR_OF_MEAN|0.234|||TWO_SIDED|90.0|0.934|2.122|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||2.122|0.934|
71818463|NCT00453479|143140292|SUPERIORITY_OR_OTHER||Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.2482|||TWO_SIDED|90.0|0.77|1.838|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.838|0.770|
71818464|NCT00453479|143140292|SUPERIORITY_OR_OTHER||Ratio|0.979|STANDARD_ERROR_OF_MEAN|0.2269|||TWO_SIDED|90.0|0.658|1.457|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||1.457|0.658|
71818465|NCT00453479|143140292|SUPERIORITY_OR_OTHER||Ratio|1.028|STANDARD_ERROR_OF_MEAN|0.2407|||TWO_SIDED|90.0|0.674|1.568|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||1.568|0.674|
71818466|NCT00453479|143140294|SUPERIORITY_OR_OTHER||Ratio|2.556|STANDARD_ERROR_OF_MEAN|0.131|||TWO_SIDED|90.0|2.033|3.213|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.|||3.213|2.033|
71679528|NCT02612610|142877079|OTHER||LS Mean Difference|-10.7||||0.0197|TWO_SIDED|95.0|-19.8|-1.7|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-1.7|-19.8|0.0197
71679529|NCT02612610|142877080|OTHER||LS Mean Difference|-4.4||||0.302|TWO_SIDED|95.0|-12.9|4.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.0|-12.9|0.3020
71818467|NCT00453479|143140294|SUPERIORITY_OR_OTHER||Ratio|1.644|STANDARD_ERROR_OF_MEAN|0.138|||TWO_SIDED|90.0|1.29|2.095|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.|||2.095|1.290|
71818468|NCT01763788|143140298|SUPERIORITY||Stratified Hazard Ratio|0.656||||0.0161|TWO_SIDED|95.0|0.465|0.926|||Stratified Log Rank|||||0.926|0.465|0.0161
71818469|NCT02354859|143140315|SUPERIORITY||Difference in Proportions|5.9||||0.811|TWO_SIDED|95.0|-11.2|22.4|||Cochran-Mantel-Haenszel||The estimate is adjusted for baseline FEV1 % predicted strata (\<50% of predicted, between 50% and 70% of predicted, and \>70% of predicted).|||22.4|-11.2|0.811
71818470|NCT02354859|143140316|SUPERIORITY||Difference in Proportions-SAE inicidence|3.1||||0.807|TWO_SIDED|95.0|-10.6|16.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||16.6|-10.6|0.807
71818471|NCT02354859|143140317|SUPERIORITY||Rate Ratio|0.81||||0.002|TWO_SIDED|95.0|0.71|0.93|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks of all participants (not per participant) in the trial was as follows: in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||0.93|0.71|0.002
71818472|NCT02354859|143140317|SUPERIORITY||Rate Ratio|0.89||||0.783|TWO_SIDED|95.0|0.39|2.03|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the IV Gallium group was 486.86 and in the Placebo group was 473.57.||2.03|0.39|0.783
71818473|NCT02354859|143140318|SUPERIORITY||Mean Difference (Final Values)|2.05||||0.479|TWO_SIDED|95.0|-3.66|7.77|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline FEV1 (liters), treatment, visit and a visit-by-visit interaction.|||7.77|-3.66|0.479
71818474|NCT02354859|143140319|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.054|TWO_SIDED|95.0|-1.49|0.01|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 28 and Day 56. Mixed-effects repeated measures model includes terms for the baseline Pa density (log10 (CFU)), treatment, visit and a visit-by-visit interaction.|||0.01|-1.49|0.054
71818475|NCT02354859|143140320|SUPERIORITY||Mean Difference (Final Values)|4.23||||0.053|TWO_SIDED|95.0|-0.06|8.53|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline CFRSD-CRISS score, treatment, visit and a visit-by-visit interaction.|||8.53|-0.06|0.053
71818476|NCT04711460|143140321|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.003|STANDARD_DEVIATION|5.59||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||||0.003
71818477|NCT04711460|143140321|SUPERIORITY|The threshold for statistical significance was set at p=0.05. No power analysis was conducted.|Mean Difference (Final Values)|0.009|STANDARD_DEVIATION|5.59||0.009|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.009
71818478|NCT04711460|143140321|SUPERIORITY|The Tukey Kramer Post Hoc Test q value = 0.05 threshold|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.609|<|0.05|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Tukey Kramer Post-Hoc|Threshold of statistically significance was set at p=0.05.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||<0.05
71818479|NCT04711460|143140321|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.13||0.003|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.003
71818480|NCT04711460|143140321|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.07||0.454|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.454
71818481|NCT04711460|143140322|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|7.194||0.002|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|||||0.002
71818482|NCT04711460|143140322|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.09||0.054|ONE_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.054
71818483|NCT04711460|143140322|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.93||0.019|TWO_SIDED|0.05||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|t-test, 2 sided|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.019
71818484|NCT04711460|143140322|SUPERIORITY|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|6.04||0.101|ONE_SIDED|95.0||||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.|ANOVA|Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||Threshold of statistically significance was set at p=0.05. No power calculation was conducted.||||0.101
71818485|NCT02771210|143140325|SUPERIORITY||Odds Ratio (OR)|1.63||||0.136|TWO_SIDED|95.0|0.87|3.08|||Regression, Logistic|||||3.08|0.87|0.136
71850279|NCT00912964|143213957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|||<|0.001|TWO_SIDED|95.0|-0.22|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.06|-0.22|<0.001
71818486|NCT04397523|143140342|OTHER|||||||0.05||||||p=0.00000|ANOVA|df 2||||||0.05
71850280|NCT00912964|143213958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.36||||0.004|TWO_SIDED|95.0|-0.67|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.05|-0.67|0.004
71850281|NCT00912964|143213958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39||||0.002|TWO_SIDED|95.0|-0.69|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.||-0.08|-0.69|0.002
71850282|NCT00912964|143213959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33||||0.13|TWO_SIDED|95.0|-0.76|0.1||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||0.10|-0.76|0.13
71850283|NCT00912964|143213959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.59||||0.007|TWO_SIDED|95.0|-1.01|-0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.||-0.16|-1.01|0.007
71850284|NCT02978716|143213991|SUPERIORITY||Mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.58||0.7048|TWO_SIDED|95.0|-0.8|1.5||A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level.|Analysis of covariance (ANCOVA)|||Duration of SN in Cycle 1 in Group 3 vs Group 1.||1.5|-0.8|0.7048
71900717|NCT00418262|143323026|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.28|0.26|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.26|-0.28|
71818487|NCT04397523|143140347|OTHER|||||||0.05||||||Chi- square = 24.98174, p = 0.00000|Chi-squared|df = 2||Overall survival between the three WHO score groups 3, 4 and 5||||0.05
71818488|NCT04397523|143140347|OTHER|||||||0.05||||||p=0.000|Chi-squared|df = 2||Correlation of mortality versus WHO disease progression score of patients||||0.05
71818489|NCT04397523|143140347|OTHER|||||||0.05||||||p = 0.000|Chi-squared|df = 1||Correlation of mortality versus stay in the intensive care unit (ICU)||||0.05
71818490|NCT01275196|143140348|NON_INFERIORITY_OR_EQUIVALENCE|This trial was powered to detect an odds ratio of at least 2.333 which corresponds, for example, to increases of 18% (from 22% to 40%) and increases of 20% (from 30% to 50%).||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
71818491|NCT02572817|143140374|SUPERIORITY||Odds Ratio (OR)|1.22||||0.54|TWO_SIDED|95.0|0.65|2.29|||Regression, Logistic|||||2.29|0.65|0.54
71818492|NCT02572817|143140375|SUPERIORITY||Odds Ratio (OR)|0.86||||0.66|TWO_SIDED|95.0|0.45|1.66|||Regression, Logistic|||||1.66|0.45|0.66
71679530|NCT02612610|142877080|OTHER||LS Mean Difference|-6.4||||0.1365|TWO_SIDED|95.0|-14.8|2.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.0|-14.8|0.1365
71679531|NCT02612610|142877080|OTHER||LS Mean Difference|-11.2||||0.0108|TWO_SIDED|95.0|-19.7|-2.6|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-2.6|-19.7|0.0108
71679532|NCT02612610|142877081|OTHER||LS Mean Difference|-4.0||||0.3509|TWO_SIDED|95.0|-12.3|4.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||4.4|-12.3|0.3509
71900718|NCT00418262|143323026|SUPERIORITY||Mean Difference (Net)|-0.01|||||TWO_SIDED|95.0|-0.56|0.52|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.52|-0.56|
71679533|NCT02612610|142877081|OTHER||LS Mean Difference|-8.2||||0.0519|TWO_SIDED|95.0|-16.6|0.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-16.6|0.0519
71818493|NCT02572817|143140376|SUPERIORITY||Odds Ratio (OR)|0.95||||0.87|TWO_SIDED|95.0|0.5|1.8|||Regression, Logistic|||||1.8|0.5|0.87
71818494|NCT02572817|143140377|SUPERIORITY||Odds Ratio (OR)|1.26||||0.49|TWO_SIDED|95.0|0.65|2.41|||Regression, Logistic|||||2.41|0.65|0.49
71818495|NCT02572817|143140378|SUPERIORITY||Odds Ratio (OR)|1.07||||0.83|TWO_SIDED|95.0|0.55|2.08|||Regression, Logistic|||||2.08|0.55|0.83
71818496|NCT02572817|143140379|SUPERIORITY||Odds Ratio (OR)|1.29||||0.47|TWO_SIDED|95.0|0.65|2.56|||Regression, Logistic|||||2.56|0.65|0.47
71818497|NCT02572817|143140380|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71818498|NCT02572817|143140381|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.64|TWO_SIDED|95.0|0.21|2.64|||Log Rank|||||2.64|0.21|0.64
71818499|NCT02572817|143140382|SUPERIORITY|||||||0.69|||||||Fisher Exact|||||||0.69
71818500|NCT02572817|143140383|SUPERIORITY||Odds Ratio (OR)|1.33||||0.43|TWO_SIDED|95.0|0.65|2.71|||Regression, Logistic|||Composite mortality and hospitalization, Day 7||2.71|0.65|0.43
71818501|NCT02572817|143140383|SUPERIORITY||Odds Ratio (OR)|1.11||||0.79|TWO_SIDED|95.0|0.5|2.48|||Regression, Logistic|||Composite mortality and hospitalization, Day 14||2.48|0.5|0.79
71818502|NCT02572817|143140383|SUPERIORITY||Odds Ratio (OR)|1.65||||0.29|TWO_SIDED|95.0|0.66|4.12|||Regression, Logistic|||Composite mortality and hospitalization, Day 28||4.12|0.66|0.29
71818503|NCT02572817|143140384|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.2|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||0|-2|0.2
71818504|NCT02572817|143140384|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.66|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3||1|-1|0.66
71818505|NCT02572817|143140385|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 3||||0.18
71818506|NCT02572817|143140385|SUPERIORITY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 7||||0.61
71818507|NCT02572817|143140386|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.68|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-2|0.68
71818508|NCT02572817|143140387|SUPERIORITY||Odds Ratio (OR)|1.42||||0.98|TWO_SIDED|95.0|0.23|11.01|||Regression, Logistic|||||11.01|0.23|0.98
71818509|NCT02572817|143140388|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.5||||0.37|TWO_SIDED|95.0|-6.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-6|0.37
71818510|NCT02572817|143140389|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
71818511|NCT02572817|143140390|SUPERIORITY||Hodges-Lehman estimate of location shift|-3.0||||0.22|TWO_SIDED|95.0|-14.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-14|0.22
71818512|NCT02572817|143140391|SUPERIORITY||Odds Ratio (OR)|0.74||||1|TWO_SIDED|95.0|0.08|9.29|||Regression, Logistic|||||9.29|0.08|1
71818513|NCT02572817|143140393|SUPERIORITY||Odds Ratio (OR)|0.33||||0.24|TWO_SIDED|95.0|0.05|1.79|||Regression, Logistic|||||1.79|0.05|0.24
71818514|NCT02572817|143140395|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71818515|NCT02572817|143140396|SUPERIORITY||Hodges-Lehman estimate of location shift|0.0||||0.06|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 3||0|-1|0.06
71818516|NCT02572817|143140396|SUPERIORITY||Hodges-Lehman estimate of location shift|-1.0||||0.13|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 7||0|-1|0.13
71818517|NCT02572817|143140397|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 3||||0.36
71818518|NCT02572817|143140397|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 7||||0.15
71818519|NCT02572817|143140398|SUPERIORITY||Odds Ratio (OR)|1.73||||0.12|TWO_SIDED|95.0|0.87|3.44|||Regression, Logistic|||||3.44|0.87|0.12
71818520|NCT02572817|143140399|SUPERIORITY||Odds Ratio (OR)|0.47||||0.23|TWO_SIDED|95.0|0.13|1.43|||Regression, Logistic|||||1.43|0.13|0.23
71900719|NCT00418262|143323027|SUPERIORITY||Mean Difference (Net)|-0.06|||||TWO_SIDED|95.0|-0.32|0.2|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.20|-0.32|
71900720|NCT00418262|143323027|SUPERIORITY||Median Difference (Net)|-0.12|||||TWO_SIDED|95.0|-0.64|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.39|-0.64|
71900721|NCT00418262|143323028|SUPERIORITY||Mean Difference (Net)|-0.05|||||TWO_SIDED|95.0|-0.28|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.24|-0.28|
71900722|NCT00418262|143323028|SUPERIORITY||Mean Difference (Net)|-0.09|||||TWO_SIDED|95.0|-0.57|0.47|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.47|-0.57|
71900723|NCT00418262|143323029|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
71900724|NCT00418262|143323029|SUPERIORITY||Mean Difference (Net)|0.07|||||TWO_SIDED|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.32|-0.21|
71900725|NCT00418262|143323030|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.36|0.13|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.13|-0.36|
71900726|NCT00418262|143323030|SUPERIORITY||Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.72|0.27|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.27|-0.72|
71900727|NCT00418262|143323031|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
71818521|NCT02441946|143140410|SUPERIORITY||Ratio of Geometric Means|0.19|||<|0.001|TWO_SIDED|90.0|0.13|0.28|||t-test, 1 sided|||||0.28|0.13|<0.001
71818522|NCT02441946|143140410|SUPERIORITY||Ratio of Geometric Means|0.25|||<|0.001|TWO_SIDED|90.0|0.17|0.38|||t-test, 1 sided|||||0.38|0.17|<0.001
71818523|NCT02761629|143140420|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.7||||0.0536|TWO_SIDED|95.0|-0.01|26.6|||Fisher Exact||Exact 95% confidence interval was from the binomial distribution for response rate.|||26.6|-0.01|0.0536
71818524|NCT02761629|143140423|SUPERIORITY_OR_OTHER|||||||0.0175|||||||Fisher Exact|||||||0.0175
71818525|NCT02001974|143140435|OTHER|||||||0.0341|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0341
71818526|NCT02001974|143140435|OTHER|||||||0.0636|||||||ANOVA|||DF1681Y Cmax at Day -3||||0.0636
71818527|NCT02001974|143140435|OTHER|||||||0.0487|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.0487
71818528|NCT02001974|143140435|OTHER|||||||0.3498|||||||ANOVA|||DF1681Y Cmax at Day 1||||0.3498
71818529|NCT02001974|143140435|OTHER|||||||0.0096|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.0096
71818530|NCT02001974|143140435|OTHER|||||||0.1374|||||||ANOVA|||DF1681Y Cmax at Day 8||||0.1374
71818531|NCT02001974|143140435|OTHER|||||||0.0065|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.0065
71818532|NCT02001974|143140435|OTHER|||||||0.147|||||||ANOVA|||DF1681Y Cmax at Day 21||||0.1470
71818533|NCT02001974|143140436|OTHER|||||||0.0015|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0015
71818534|NCT02001974|143140436|OTHER|||||||0.0176|||||||ANOVA|||DF2243 Cmax at Day -3||||0.0176
71818535|NCT02001974|143140436|OTHER|||||||0.0048|||||||ANOVA|||DF2243 Cmax at Day 1||||0.0048
71818536|NCT02001974|143140436|OTHER|||||||0.2083|||||||ANOVA|||DF2243 Cmax at Day 1||||0.2083
71818537|NCT02001974|143140436|OTHER|||||||0.0111|||||||ANOVA|||DF2243 Cmax at Day 8||||0.0111
71818538|NCT02001974|143140436|OTHER|||||||0.1441|||||||ANOVA|||DF2243 Cmax at Day 8||||0.1441
71818539|NCT02001974|143140436|OTHER|||||||0.0283|||||||ANOVA|||DF2243 Cmax at Day 21||||0.0283
71818540|NCT02001974|143140436|OTHER|||||||0.1331|||||||ANOVA|||DF2243 Cmax at Day 21||||0.1331
71818541|NCT02001974|143140437|OTHER|||||||0.0097|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0097
71818542|NCT02001974|143140437|OTHER|||||||0.0354|||||||ANOVA|||DF2188Y, Cmax, Day -3||||0.0354
71818543|NCT02001974|143140437|OTHER|||||||0.02|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.0200
71818544|NCT02001974|143140437|OTHER|||||||0.2134|||||||ANOVA|||DF2188Y, Cmax, Day 1||||0.2134
71818545|NCT02001974|143140437|OTHER|||||||0.0235|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0235
71818546|NCT02001974|143140437|OTHER|||||||0.0964|||||||ANOVA|||DF2188Y, Cmax, Day 8||||0.0964
71818547|NCT02001974|143140437|OTHER|||||||0.0314|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0314
71818548|NCT02001974|143140437|OTHER|||||||0.0773|||||||ANOVA|||DF2188Y, Cmax, Day 21||||0.0773
71818549|NCT02001974|143140438|OTHER|||||||0.1016|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.1016
71818550|NCT02001974|143140438|OTHER|||||||0.2001|||||||ANOVA|||Cmax, ibuprofen, Day -3||||0.2001
71818551|NCT02001974|143140438|OTHER|||||||0.0802|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.0802
71818552|NCT02001974|143140438|OTHER|||||||0.4728|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.4728
71818553|NCT02001974|143140438|OTHER|||||||0.0355|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0355
71818554|NCT02001974|143140438|OTHER|||||||0.1709|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1709
71818555|NCT02001974|143140438|OTHER|||||||0.0685|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.0685
71818556|NCT02001974|143140438|OTHER|||||||0.3189|||||||ANOVA|||Cmax, ibuprofen, Day 21||||0.3189
71818557|NCT02001974|143140439|OTHER|||||||0.2375|||||||ANOVA|||Paclitaxel, Cmax, Day 1||||0.2375
71818558|NCT02001974|143140439|OTHER|||||||0.3608|||||||ANOVA|||Cmax, ibuprofen, Day 1||||0.3608
71818559|NCT02001974|143140439|OTHER|||||||0.0442|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.0442
71818560|NCT02001974|143140439|OTHER|||||||0.1067|||||||ANOVA|||Cmax, ibuprofen, Day 8||||0.1067
71818561|NCT02001974|143140445|OTHER|||||||0.0134|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0134
71818562|NCT02001974|143140445|OTHER|||||||0.0799|||||||ANOVA|||DF1681Y, AUC0-8, Day -3||||0.0799
71818563|NCT02001974|143140445|OTHER|||||||0.0241|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.0241
71818564|NCT02001974|143140445|OTHER|||||||0.01384|||||||ANOVA|||DF1681Y, AUC0-8, Day 1||||0.01384
71818565|NCT02001974|143140445|OTHER|||||||0.0091|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.0091
71818566|NCT02001974|143140445|OTHER|||||||0.5687|||||||ANOVA|||DF1681Y, AUC0-8, Day 8||||0.5687
71818567|NCT02001974|143140445|OTHER|||||||0.0058|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.0058
71818568|NCT02001974|143140445|OTHER|||||||0.3667|||||||ANOVA|||DF1681Y, AUC0-8, Day 21||||0.3667
71818569|NCT02001974|143140446|OTHER|||||||0.0029|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0029
71818570|NCT02001974|143140446|OTHER|||||||0.0349|||||||ANOVA|||DF2243Y - AUC0-8 - Day -3||||0.0349
71818571|NCT02001974|143140446|OTHER|||||||0.0119|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.0119
71818572|NCT02001974|143140446|OTHER|||||||0.21|||||||ANOVA|||DF2243Y - AUC0-8 - Day 1||||0.2100
71818573|NCT02001974|143140446|OTHER|||||||0.0165|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.0165
71818574|NCT02001974|143140446|OTHER|||||||0.1496|||||||ANOVA|||DF2243Y - AUC0-8 - Day 8||||0.1496
71818575|NCT02001974|143140446|OTHER|||||||0.0321|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.0321
71818576|NCT02001974|143140446|OTHER|||||||0.1404|||||||ANOVA|||DF2243Y - AUC0-8 - Day 21||||0.1404
71818577|NCT02001974|143140447|OTHER|||||||0.0081|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0081
71818578|NCT02001974|143140447|OTHER|||||||0.064|||||||ANOVA|||AUC0-8 for DF2188Y, Day -3||||0.0640
71818579|NCT02001974|143140447|OTHER|||||||0.0397|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.0397
71818580|NCT02001974|143140447|OTHER|||||||0.1898|||||||ANOVA|||AUC0-8 for DF2188Y, Day 1||||0.1898
71818581|NCT02001974|143140447|OTHER|||||||0.025|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.0250
71818582|NCT02001974|143140447|OTHER|||||||0.1605|||||||ANOVA|||AUC0-8 for DF2188Y, Day 8||||0.1605
71818583|NCT02001974|143140447|OTHER|||||||0.0786|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.0786
71818584|NCT02001974|143140447|OTHER|||||||0.2652|||||||ANOVA|||AUC0-8 for DF2188Y, Day 21||||0.2652
71818585|NCT02001974|143140448|OTHER|||||||0.1335|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.1335
71818586|NCT02001974|143140448|OTHER|||||||0.2658|||||||ANOVA|||Ibuprofen, AUC0-8, Day -3||||0.2658
71818587|NCT02001974|143140448|OTHER|||||||0.1063|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1063
71818588|NCT02001974|143140448|OTHER|||||||0.4959|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.4959
71818589|NCT02001974|143140448|OTHER|||||||0.0452|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0452
71818590|NCT02001974|143140448|OTHER|||||||0.2223|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.2223
71818591|NCT02001974|143140448|OTHER|||||||0.0737|||||||ANOVA|||Ibuprofen, AUC0-8, Day 21||||0.0737
71818592|NCT02001974|143140448|OTHER|||||||0.2804|||||||ANOVA|||Ibuprofen, AUC0-8, Day21||||0.2804
71818593|NCT02001974|143140449|OTHER|||||||0.1449|||||||ANOVA|||Paclitaxel, AUC0-8, Day 1||||0.1449
71818594|NCT02001974|143140449|OTHER|||||||0.1338|||||||ANOVA|||Ibuprofen, AUC0-8, Day 1||||0.1338
71818595|NCT02001974|143140449|OTHER|||||||0.0633|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.0633
71818596|NCT02001974|143140449|OTHER|||||||0.6939|||||||ANOVA|||Ibuprofen, AUC0-8, Day 8||||0.6939
71818597|NCT00119262|143140461|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|95.0|||||Fisher Exact|||||||0.12
71818598|NCT00119262|143140462|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Fisher Exact|||||||0.32
71818599|NCT04844918|143140466|SUPERIORITY||LS Mean Difference|-16.1|||<|0.001|TWO_SIDED|95.0|-18.7|-13.5|||Mixed Models Analysis|||||-13.5|-18.7|<0.001
71818600|NCT04844918|143140466|SUPERIORITY||LS Mean Difference|-21.1|||<|0.001|TWO_SIDED|95.0|-23.6|-18.5|||Mixed Models Analysis|||||-18.5|-23.6|<0.001
71818601|NCT04844918|143140467|SUPERIORITY||Odds Ratio (OR)|119.65|||<|0.001|TWO_SIDED|95.0|29.06|492.67|||Mixed Models Analysis|||||492.67|29.06|<0.001
71818602|NCT04844918|143140467|SUPERIORITY||Odds Ratio (OR)|153.57|||<|0.001|TWO_SIDED|95.0|36.03|654.53|||Mixed Models Analysis|||||654.53|36.03|<0.001
71818603|NCT04844918|143140468|SUPERIORITY||Odds Ratio (OR)|24.26|||<|0.001|TWO_SIDED|95.0|8.62|68.28|||Regression, Logistic|||||68.28|8.62|<0.001
71818604|NCT04844918|143140468|SUPERIORITY||Odds Ratio (OR)|38.27|||<|0.001|TWO_SIDED|95.0|13.21|110.89|||Regression, Logistic|||||110.89|13.21|<0.001
71818605|NCT04844918|143140469|SUPERIORITY||LS Mean Difference|-15.0|||<|0.001|TWO_SIDED|95.0|-18.91|-11.09|||Mixed Models Analysis|||||-11.09|-18.91|<0.001
71818606|NCT04844918|143140469|SUPERIORITY||LS Mean Difference|-12.8|||<|0.001|TWO_SIDED|95.0|-16.56|-9.05|||Mixed Models Analysis|||||-9.05|-16.56|<0.001
71818607|NCT04844918|143140470|SUPERIORITY||LS Mean Difference|-55.76|||<|0.001|TWO_SIDED|95.0|-69.74|-41.77|||Mixed Models Analysis|||||-41.77|-69.74|<0.001
71818608|NCT04844918|143140470|SUPERIORITY||LS Mean Difference|-64.82|||<|0.001|TWO_SIDED|95.0|-78.2|-51.43|||Mixed Models Analysis|||||-51.43|-78.20|<0.001
71818609|NCT04844918|143140471|SUPERIORITY||LS Mean Difference|-40.7|||<|0.001|TWO_SIDED|95.0|-50.0|-29.7|||Mixed Models Analysis|||||-29.7|-50.0|<0.001
71818610|NCT04844918|143140471|SUPERIORITY||LS Mean Difference|-44.5|||<|0.001|TWO_SIDED|95.0|-52.7|-34.9|||Mixed Models Analysis|||||-34.9|-52.7|<0.001
71818611|NCT04844918|143140472|SUPERIORITY||LS Mean Difference|-44.4|||<|0.001|TWO_SIDED|95.0|-53.0|-35.7|||ANCOVA|||||-35.7|-53.0|<0.001
71818612|NCT04844918|143140472|SUPERIORITY||LS Mean Difference|-50.4|||<|0.001|TWO_SIDED|95.0|-58.8|-41.9|||ANCOVA|||||-41.9|-58.8|<0.001
71818613|NCT04844918|143140473|SUPERIORITY||Odds Ratio (OR)|25.42|||<|0.001|TWO_SIDED|95.0|7.25|89.14|||Regression, Logistic|||||89.14|7.25|<0.001
71818614|NCT04844918|143140473|SUPERIORITY||Odds Ratio (OR)|70.66|||<|0.001|TWO_SIDED|95.0|12.73|392.24|||Regression, Logistic|||||392.24|12.73|<0.001
71818615|NCT04844918|143140474|SUPERIORITY||Odds Ratio (OR)|9.29|||<|0.001|TWO_SIDED|95.0|2.86|30.2|||Regression, Logistic|||||30.20|2.86|<0.001
71818616|NCT04844918|143140474|SUPERIORITY||Odds Ratio (OR)|15.67|||<|0.001|TWO_SIDED|95.0|4.78|51.37|||Regression, Logistic|||||51.37|4.78|<0.001
71818617|NCT04844918|143140475|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|9.35|80.88|||Regression, Logistic|||||80.88|9.35|<0.001
71818618|NCT04844918|143140475|SUPERIORITY||Odds Ratio (OR)|40.01|||<|0.001|TWO_SIDED|95.0|13.27|120.57|||Regression, Logistic|||||120.57|13.27|<0.001
71818619|NCT04844918|143140476|SUPERIORITY||Odds Ratio (OR)|185.92|||<|0.001|TWO_SIDED|95.0|46.39|745.16|||Regression, Logistic|||||745.16|46.39|<0.001
71818620|NCT04844918|143140476|SUPERIORITY||Odds Ratio (OR)|318.02|||<|0.001|TWO_SIDED|95.0|74.49|1357.79|||Regression, Logistic|||||1357.79|74.49|<0.001
71818621|NCT04844918|143140477|SUPERIORITY||Odds Ratio (OR)|100.21|||<|0.001|TWO_SIDED|95.0|18.64|538.74|||Regression, Logistic|||||538.74|18.64|<0.001
71818622|NCT04844918|143140477|SUPERIORITY||Odds Ratio (OR)|286.73|||<|0.001|TWO_SIDED|95.0|50.68|1622.06|||Regression, Logistic|||||1622.06|50.68|<0.001
71818623|NCT04844918|143140478|SUPERIORITY||LS Mean Difference|-14.5|||<|0.001|TWO_SIDED|95.0|-16.8|-12.2|||Mixed Models Analysis|||||-12.2|-16.8|<0.001
71818624|NCT04844918|143140478|SUPERIORITY||LS Mean Difference|-19.3|||<|0.001|TWO_SIDED|95.0|-21.6|-17.0|||Mixed Models Analysis|||||-17.0|-21.6|<0.001
71818625|NCT04844918|143140479|SUPERIORITY||LS Mean Difference|-5.2|||<|0.001|TWO_SIDED|95.0|-6.1|-4.4|||Mixed Models Analysis|||||-4.4|-6.1|<0.001
71818626|NCT04844918|143140479|SUPERIORITY||LS Mean Difference|-7.1|||<|0.001|TWO_SIDED|95.0|-8.0|-6.3|||Mixed Models Analysis|||||-6.3|-8.0|<0.001
71818627|NCT04844918|143140480|SUPERIORITY||LS Mean Difference|-36.1|||<|0.001|TWO_SIDED|95.0|-42.9|-29.3|||Mixed Models Analysis|||||-29.3|-42.9|<0.001
71818628|NCT04844918|143140480|SUPERIORITY||LS Mean Difference|-41.1|||<|0.001|TWO_SIDED|95.0|-47.8|-34.4|||Mixed Models Analysis|||||-34.4|-47.8|<0.001
71818629|NCT04844918|143140481|SUPERIORITY||LS Mean Difference|-27.2|||<|0.001|TWO_SIDED|95.0|-32.6|-21.9|||Mixed Models Analysis|||||-21.9|-32.6|<0.001
71818630|NCT04844918|143140481|SUPERIORITY||LS Mean Difference|-31.5|||<|0.001|TWO_SIDED|95.0|-36.7|-26.2|||Mixed Models Analysis|||||-26.2|-36.7|<0.001
71818631|NCT04844918|143140482|SUPERIORITY||LS Mean Difference|-0.1||||0.004|TWO_SIDED|95.0|-0.16|-0.03|||Mixed Models Analysis|||||-0.03|-0.16|0.004
71818632|NCT04844918|143140482|SUPERIORITY||LS Mean Difference|-0.09||||0.006|TWO_SIDED|95.0|-0.15|-0.03|||Mixed Models Analysis|||||-0.03|-0.15|0.006
71818633|NCT04844918|143140483|SUPERIORITY||Odds Ratio (OR)|28.52|||<|0.001|TWO_SIDED|95.0|4.31|188.55|||Regression, Logistic|||||188.55|4.31|<0.001
71818634|NCT04844918|143140483|SUPERIORITY||Odds Ratio (OR)|57.73|||<|0.001|TWO_SIDED|95.0|8.68|383.88|||Regression, Logistic|||||383.88|8.68|<0.001
71818635|NCT04844918|143140484|SUPERIORITY||LS Mean Difference|-11.4|||<|0.001|TWO_SIDED|95.0|-13.8|-9.0|||Mixed Models Analysis|||||-9.0|-13.8|<0.001
71818636|NCT04844918|143140484|SUPERIORITY||LS Mean Difference|-15.3|||<|0.001|TWO_SIDED|95.0|-17.7|-13.0|||Mixed Models Analysis|||||-13.0|-17.7|<0.001
71818637|NCT04844918|143140485|SUPERIORITY||LS Mean Difference|-0.65|||<|0.001|TWO_SIDED|95.0|-0.77|-0.53|||Mixed Models Analysis|||||-0.53|-0.77|<0.001
71818638|NCT04844918|143140485|SUPERIORITY||LS Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.77|-0.55|||Mixed Models Analysis|||||-0.55|-0.77|<0.001
71818639|NCT04844918|143140486|SUPERIORITY||LS Mean Difference|-3.91|||||TWO_SIDED|95.0|-5.74|-2.08||||||||-2.08|-5.74|
71818640|NCT04844918|143140486|SUPERIORITY||LS Mean Difference|-4.55|||||TWO_SIDED|95.0|-6.29|-2.81||||||||-2.81|-6.29|
71900728|NCT00418262|143323031|SUPERIORITY||Mean Difference (Net)|0.08|||||TWO_SIDED|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||0.35|-0.19|
71900729|NCT00418262|143323032|SUPERIORITY||Mean Difference (Net)|-7.4|||||TWO_SIDED|95.0|-7.76|-7.04|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-7.04|-7.76|
71900730|NCT00418262|143323032|SUPERIORITY||Mean Difference (Net)|-2.44|||||TWO_SIDED|95.0|-3.03|-1.9|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||-1.90|-3.03|
71900731|NCT00418262|143323033|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
71900732|NCT00418262|143323033|SUPERIORITY||Mean Difference (Net)|0.39|||||TWO_SIDED|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."||1.38|-0.69|
71900733|NCT05022004|143323034|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-0.28|0.91|||||The reported mean difference represents value for Left Eye at Week 2, 08:00am|||0.91|-0.28|
71900734|NCT05022004|143323034|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-0.39|0.76|||||The reported mean difference represents value for Right Eye at Week 2, 08:00am|||0.76|-0.39|
71900735|NCT05022004|143323034|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.59|0.5|||||The reported mean difference represents value for Left Eye at Week 6, 08:00am|||0.50|-0.59|
71818641|NCT04844918|143140487|SUPERIORITY||LS Mean Difference|-13.2|||<|0.001|TWO_SIDED|95.0|-17.0|-9.3|||Mixed Models Analysis|||||-9.3|-17.0|<0.001
71818642|NCT04844918|143140487|SUPERIORITY||LS Mean Difference|-13.9|||<|0.001|TWO_SIDED|95.0|-17.7|-10.1|||Mixed Models Analysis|||||-10.1|-17.7|<0.001
71818643|NCT04844918|143140488|SUPERIORITY||LS Mean Difference|-6.3|||<|0.001|TWO_SIDED|95.0|-9.3|-3.4|||Mixed Models Analysis|||||-3.4|-9.3|<0.001
71818644|NCT04844918|143140488|SUPERIORITY||LS Mean Difference|-6.8|||<|0.001|TWO_SIDED|95.0|-9.7|-3.9|||Mixed Models Analysis|||||-3.9|-9.7|<0.001
71818645|NCT04844918|143140489|SUPERIORITY||LS Mean Difference|1.3||||0.022|TWO_SIDED|95.0|0.2|2.3|||ANCOVA|||||2.3|0.2|0.022
71818646|NCT04844918|143140489|SUPERIORITY||LS Mean Difference|2.1|||<|0.001|TWO_SIDED|95.0|1.1|3.2|||ANCOVA|||||3.2|1.1|<0.001
71818647|NCT04844918|143140490|SUPERIORITY||LS Mean Difference|13.0|||<|0.001|TWO_SIDED|95.0|7.4|18.7|||ANCOVA|||||18.7|7.4|<0.001
71818648|NCT04844918|143140490|SUPERIORITY||LS Mean Difference|10.8|||<|0.001|TWO_SIDED|95.0|5.4|16.3|||ANCOVA|||||16.3|5.4|<0.001
71818649|NCT04844918|143140491|SUPERIORITY||LS Mean Difference|0.03||||0.099|TWO_SIDED|95.0|0.0|0.06|||ANCOVA|||||0.06|0.00|0.099
71818650|NCT04844918|143140491|SUPERIORITY||LS Mean Difference|0.02||||0.236|TWO_SIDED|95.0|-0.01|0.05|||ANCOVA|||||0.05|-0.01|0.236
71818651|NCT00924469|143140509|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.61||||0.0216||90.0|0.429|0.865||Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 12||0.865|0.429|0.0216
71818652|NCT00924469|143140510|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.43||||0.1423||90.0|0.956|2.145||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 24||2.145|0.956|0.1423
71818653|NCT00924469|143140510|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.82||||0.6639||90.0|0.386|1.746||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 24||1.746|0.386|0.6639
71818654|NCT00924469|143140511|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.32|||<|0.0001||90.0|0.239|0.418||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for androstenedione concentration at Week 12||0.418|0.239|<0.0001
71818655|NCT00924469|143140511|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.13||||0.5061||90.0|0.828|1.554||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for androstenedione concentration at Week 24||1.554|0.828|0.5061
71818656|NCT00924469|143140511|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.03|||<|0.0001||90.0|0.017|0.05||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 3 for DHEA concentration at Week 12||0.050|0.017|<0.0001
71818657|NCT00924469|143140511|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.79||||0.5767||90.0|0.398|1.581||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 4 for DHEA concentration at Week 24||1.581|0.398|0.5767
71818658|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.14|||<|0.0001||90.0|0.097|0.207||Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 1 for serum testosterone concentration at Week 12||0.207|0.097|<0.0001
71818659|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.4364||90.0|0.571|1.225||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 2 for serum testosterone concentration at Week 24||1.225|0.571|0.4364
71818660|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.75||||0.1515||90.0|0.54|1.044||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 3 for serum DHT concentration at Week 12||1.044|0.540|0.1515
71818661|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.84||||0.3965||90.0|0.589|1.188||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 4 for serum DHT concentration at Week 24||1.188|0.589|0.3965
71818662|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42||||0.0003||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 5 for serum Androsterone concentration at Week 12||0.615|0.290|0.0003
71900736|NCT05022004|143323034|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.64|0.4|||||The reported mean difference represents value for Right Eye at Week 6, 08:00am|||0.40|-0.64|
71818663|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2494||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 6 for serum androsterone concentration at Week 24||1.625|0.916|0.2494
71818664|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.04|||<|0.0001||90.0|0.023|0.073||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 7 for serum DHEA concentration at Week 12||0.073|0.023|<0.0001
71818665|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.24||||0.5144||90.0|0.717|2.137||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 8 for serum DHEA concentration at Week 24||2.137|0.717|0.5144
71900737|NCT05022004|143323035|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0015||||||P value reported for Left Eye at Week 2; 08:00 am|two-sample t-test|||||||0.0015
71818666|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.1|||<|0.0001||90.0|0.055|0.189||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12||0.189|0.055|<0.0001
71900738|NCT05022004|143323035|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed||||||0.0008|||||||two-sample t-test|P value reported for Right Eye at Week 2; 08:00am||||||0.0008
71900739|NCT05022004|143323035|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for left eye at week 6, 08:00 am||||||<.0001
71900740|NCT05022004|143323035|EQUIVALENCE|Type of Statistical Test - Therapeutic equivalence. Sample size was based on 90% power at an alpha=0.05 significance level when the true difference between the means is 0 and SD=3.5 and the 95% equivalence limits are -1.0 and 1.0; 20% dropout was assumed|||||<|0.0001|||||||two-sample t-test|P value reported for Right eye at Week 6; 08:00 am||||||<.0001
71900741|NCT04598165|143323058|SUPERIORITY||Risk Ratio (RR)|1.25||||0.314|TWO_SIDED|95.0|0.81|1.92||The primary intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||1.92|0.81|0.314
71900742|NCT04598165|143323059|SUPERIORITY||Risk Ratio (RR)|1.36||||0.217|TWO_SIDED|95.0|0.84|2.21||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and taking into account a 10% attrition. Multiple imputation with chain equations (MICE) was used to impute missing values for any outcome with greater than 10% missingness. Any variables associated with the outcome or outcome missingness were included in the imputation model.||2.21|0.84|0.217
71900743|NCT04598165|143323060|SUPERIORITY||Risk Ratio (RR)|1.04||||0.064|TWO_SIDED|95.0|1.0|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in early initiation of breast feeding assuming 80% uptake in controls.||1.08|1.00|0.064
71900744|NCT04598165|143323061|SUPERIORITY||Risk Ratio (RR)|0.99||||0.363|TWO_SIDED|95.0|0.98|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.05 in exclusive breast feeding assuming 80% uptake in controls.||1.01|0.98|0.363
71900745|NCT04598165|143323062|SUPERIORITY||Risk Ratio (RR)|1.01||||0.093|TWO_SIDED|95.0|1.0|1.02||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.02|1.00|0.093
71900746|NCT04598165|143323063|SUPERIORITY||Risk Ratio (RR)|1.03||||0.353|TWO_SIDED|95.0|0.97|1.09||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in application of substances to the cord or delaying first bath assuming 50% in controls.||1.09|0.97|0.353
71818667|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.55||||0.1329||90.0|0.286|1.06||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24||1.060|0.286|0.1329
71818668|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.01|||<|0.0001||90.0|0.008|0.028||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12||0.028|0.008|<0.0001
71818669|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.2||||0.7061||90.0|0.53|2.73|||ANCOVA|||Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24||2.730|0.530|0.7061
71818670|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.42|||<|0.0001||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12||0.615|0.290|<0.0001
71818671|NCT00924469|143140512|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.22||||0.2673||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24||1.625|0.916|0.2673
71818672|NCT00924469|143140513|SUPERIORITY_OR_OTHER||Relative risk|25.533|||<|0.0001||90.0|4.989|130.68|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for PSA response at Week 12||130.680|4.989|<0.0001
71818673|NCT00924469|143140513|SUPERIORITY_OR_OTHER||Relative risk|1.131||||0.2319||90.0|0.956|1.337|||Cochran-Mantel-Haenszel|||Statistical Analysis 2 for PSA response at Week 24||1.337|0.956|0.2319
71850285|NCT02978716|143213991|SUPERIORITY||Mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.71||0.3364|TWO_SIDED|95.0|-0.6|2.3||2-sided p-value was calculated using a ANCOVA with study baseline ANC value as covariate, stratification factors of lines of systemic therapy, liver involvement and treatment as fixed effects.|ANCOVA|||Duration of SN in Cycle 1 in Group 2 vs Group 1.||2.3|-0.6|0.3364
71818674|NCT00924469|143140514|SUPERIORITY_OR_OTHER||Relative risk|2.744||||0.3427||90.0|1.018|5.015|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for CR at Week 24||5.015|1.018|0.3427
71818675|NCT00924469|143140517|SUPERIORITY_OR_OTHER||Adjusted mean ratio|0.17|||<|0.0001||90.0|0.098|0.289||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 12||0.289|0.098|<0.0001
71850286|NCT02978716|143213992|SUPERIORITY||Adjusted rate ratio|0.776|STANDARD_ERROR_OF_MEAN|0.2762||0.7048|TWO_SIDED|95.0|0.386|1.559||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|Modified Poisson method|||Number of participants with SN in Group 3 vs Group 1.||1.559|0.386|0.7048
71850287|NCT02978716|143213992|SUPERIORITY||Adjusted rate ratio|0.961|STANDARD_ERROR_OF_MEAN|0.364||0.9154|TWO_SIDED|95.0|0.457|2.019||The p-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||Number of participants with SN in Group 2 vs Group 1.||2.019|0.457|0.9154
71850288|NCT02978716|143213995|SUPERIORITY||Adjusted hazard ratio (HR)|0.4|STANDARD_ERROR_OF_MEAN|0.125||0.0004|TWO_SIDED|95.0|0.22|0.74||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 3 vs Group 1.||0.74|0.22|0.0004
71850289|NCT02978716|143213995|SUPERIORITY||Adjusted HR|0.31|STANDARD_ERROR_OF_MEAN|0.111||0.0016|TWO_SIDED|95.0|0.15|0.63||P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|stratified log-rank test||Cox regression model.|Overall survival in Group 2 vs Group 1.||0.63|0.15|0.0016
71850290|NCT02978716|143214015|SUPERIORITY||Adjusted HR|0.493|STANDARD_ERROR_OF_MEAN|0.1957||0.7048|TWO_SIDED|95.0|0.226|1.073||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||RBC Transfusions in Group 3 vs Group 1.||1.073|0.226|0.7048
71818676|NCT01651936|143140524|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.52||||0.308|TWO_SIDED|95.0|-1.54|0.5|||Constrained Longitudinal Data Analysis|||||0.50|-1.54|0.308
71818677|NCT01651936|143140525|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|-0.26||||0.91|TWO_SIDED|95.0|-23.52|23.01|||Cochran-Mantel-Haenszel|||||23.01|-23.52|0.91
71818678|NCT01651936|143140527|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|8.46||||0.468|TWO_SIDED|95.0|-10.4|27.32|||Cochran-Mantel-Haenszel|||||27.32|-10.40|0.468
71818679|NCT01651936|143140529|SUPERIORITY_OR_OTHER_LEGACY||Difference in least squares means|-0.41||||0.038|TWO_SIDED|95.0|-0.79|-0.02|||Constrained Longitudinal Data Analysis|||||-0.02|-0.79|0.038
71818680|NCT00981825|143140534|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71818681|NCT02743793|143140535|OTHER|No test was performed.|Kaplan-Meier survival estimate|64.0|||||TWO_SIDED|95.0|21.3|87.9|||||Percent of participants that remained tolerant during study participation.|||87.9|21.3|
71818682|NCT01461993|143140544|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82||||||95.0|0.72|0.94||||||HPV-6||0.94|0.72|
71850291|NCT02978716|143214015|SUPERIORITY||Adjusted rate ratio|0.885|STANDARD_ERROR_OF_MEAN|0.3089||0.7272|TWO_SIDED|95.0|0.447|1.754||P-value was calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as the stratification factors and baseline hemoglobin as a covariate.|Modified Poisson Regression|||RBC Transfusions in Group 2 vs Group 1.||1.754|0.447|0.7272
71850292|NCT02978716|143214016|SUPERIORITY||Adjusted rate ratio|0.988|STANDARD_ERROR_OF_MEAN|0.6105||0.7048|TWO_SIDED|95.0|0.294|3.317||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||Platelet Transfusions in Group 3 vs Group 1.||3.317|0.294|0.7048
71850293|NCT02978716|143214016|SUPERIORITY||Adjusted rate ratio|0.527|STANDARD_ERROR_OF_MEAN|0.4077||0.4078|TWO_SIDED|95.0|0.116|2.399||P-value: calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as stratification factors and baseline platelet count as a covariate.|Modified Poisson Regression|||Platelet Transfusions in Group 2 vs Group 1.||2.399|0.116|0.4078
71850294|NCT02978716|143214017|SUPERIORITY||Adjusted rate ratio|0.645|STANDARD_ERROR_OF_MEAN|0.1902||0.7048|TWO_SIDED|95.0|0.362|1.15||A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.|modified Poisson regression|||G-CSF Administration in Group 3 vs Group 1.||1.150|0.362|0.7048
71850295|NCT02978716|143214017|SUPERIORITY||Adjusted rate ratio|0.936|STANDARD_ERROR_OF_MEAN|0.226||0.7835|TWO_SIDED|95.0|0.583|1.502||P-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.|Modified Poisson Regression|||G-CSF Administration in Group 2 vs Group 1.||1.502|0.583|0.7835
71850296|NCT02978716|143214020|SUPERIORITY||Adjusted rate ratio|0.991|STANDARD_ERROR_OF_MEAN|0.3718||0.7048|TWO_SIDED|95.0|0.475|2.067||The 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global family wise error rate across the multiple null hypotheses.|negative binomial regression|||All-cause Dose Reductions in Group 3 vs Group 1.||2.067|0.475|0.7048
71850297|NCT02978716|143214020|SUPERIORITY||Adjusted rate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.2744||0.5541|TWO_SIDED|95.0|0.426|1.58||P-value was calculated using negative binomial method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.|negative binomial regression|||All-cause Dose Reductions in Group 2 vs Group 1.||1.580|0.426|0.5541
71850298|NCT02470806|143214026|NON_INFERIORITY|Stepwise regression method - Primary efficacy analysis, difference between treatment groups in percentage change in wound area from baseline visit to end of 12-week treatment period for the PP population.||||||0.001|TWO_SIDED|95.0|||||Stepwise regression|||Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)||||0.001
71850299|NCT01094106|143214039|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||In a previous non-randomised study at our institution, the mean oxycodone consumption in the control group was 60.7 mg (SD, 22.2 mg) during the first 48 h after caesarean section. At α = 0.05, 31 patients would be needed in each group to achieve a power of 90% for detecting a 30% reduction in the need for rescue opioids, which we considered a clinically meaningful effect. We decided to enrol 70 patients. The final study population was 67 patients.||||0.10
71850300|NCT01094106|143214040|SUPERIORITY|||||||0.08||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 0-6 h||||0.08
71850301|NCT01094106|143214040|SUPERIORITY|||||||0.86||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 6-12 h||||0.86
71850302|NCT01094106|143214040|SUPERIORITY|||||||0.66||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 12-24 h||||0.66
71850303|NCT01094106|143214040|SUPERIORITY|||||||0.79||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 24-36 h||||0.79
71850304|NCT01094106|143214040|SUPERIORITY|||||||0.2||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores at rest, 36-48 h||||0.20
71850305|NCT01094106|143214040|SUPERIORITY|||||||0.36||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 0-6 h||||0.36
71850306|NCT01094106|143214040|SUPERIORITY|||||||0.43||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 6-12 h||||0.43
71850307|NCT01094106|143214040|SUPERIORITY|||||||0.68||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 12-24 h||||0.68
71850308|NCT01094106|143214040|SUPERIORITY|||||||0.37||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 24-36 h||||0.37
71850309|NCT01094106|143214040|SUPERIORITY|||||||0.06||||||No adjustments for multiple comparisons|Wilcoxon (Mann-Whitney)|||Highest recorded pain scores when moving, 36-48 h||||0.06
71850310|NCT01094106|143214041|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.30
71882304|NCT01732796|143283465|SUPERIORITY_OR_OTHER||Adjusted response rate|71.7||||0.3989|TWO_SIDED|95.0|66.1|77.4|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).||77.4|66.1|0.3989
71818683|NCT01461993|143140544|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82|||||TWO_SIDED|95.0|0.74|0.91||||||HPV-11||0.91|0.74|
71818684|NCT01461993|143140544|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.88||||||HPV-16||0.88|0.68|
71818685|NCT01461993|143140544|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81||||||HPV-18||0.81|0.62|
71818686|NCT01461993|143140545|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.85|1.0||||||PMB80 \[A22\]||1.00|0.85|
71818687|NCT01461993|143140545|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||TWO_SIDED|95.0|0.84|1.01||||||PMB2948 \[B24\]||1.01|0.84|
71818688|NCT01088529|143140571|SUPERIORITY_OR_OTHER||Relative risk|1.432||||0.2148|TWO_SIDED|90.0|0.859|2.386|||Chi-squared|||||2.386|0.859|0.2148
71818689|NCT01088529|143140572|SUPERIORITY_OR_OTHER||Relative risk|0.477||||0.1796|TWO_SIDED|90.0|0.205|1.109|||Fisher Exact|||||1.109|0.205|0.1796
71818690|NCT01088529|143140573|SUPERIORITY_OR_OTHER||Relative risk|6.523|||<|0.0001|TWO_SIDED|90.0|2.701|15.753|||Chi-squared|||||15.753|2.701|<0.0001
71818691|NCT02341144|143140591|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71818692|NCT02341144|143140592|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71818693|NCT02341144|143140593|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71818694|NCT02341144|143140594|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71818695|NCT02341144|143140595|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71818696|NCT03560245|143140602|EQUIVALENCE|"The change from baseline to Week 13 in the SIB total score was summarized descriptively and compared using Analysis of Covariance (ANCOVA) adjusted for baseline SIB total score.~If the normality assumption was not met, a non-parametric method or a rank-ANCOVA analysis (i.e., an ANCOVA analysis on rank-transformed data) was to be used."||||||0.373|||||||t-test, 2 sided|||||||0.3730
71818697|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-15.9|STANDARD_ERROR_OF_MEAN|7.76||0.362|TWO_SIDED|95.0|-31.2|-0.6|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||-0.6|-31.2|0.362
71818698|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|LS mean change|-10.7|STANDARD_ERROR_OF_MEAN|7.12||0.729|TWO_SIDED|95.0|-24.8|3.3|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||3.3|-24.8|0.729
71818699|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-16.5|STANDARD_ERROR_OF_MEAN|4.73||0.173|TWO_SIDED|95.0|-25.8|-7.1|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B)||-7.1|-25.8|0.173
71818700|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) (Full analysis set)|Least Square Mean Change|-14.9|STANDARD_ERROR_OF_MEAN|3.25||0.185|TWO_SIDED|95.0|-21.3|-8.5|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B)||-8.5|-21.3|0.185
71818701|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-31.6|STANDARD_ERROR_OF_MEAN|7.71||0.02|TWO_SIDED|95.0|-46.9|-16.3|||ANCOVA|||140 micrograms of Tropifexor (Part C) vs placebo||-16.3|-46.9|0.020
71818702|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean Change|-32.5|STANDARD_ERROR_OF_MEAN|9.1||0.03|TWO_SIDED|95.0|-50.6|-14.5|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-14.5|-50.6|0.030
71818703|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.4|STANDARD_ERROR_OF_MEAN|7.86||0.456|TWO_SIDED|95.0|-26.3|-0.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A + B + C)||-0.4|-26.3|0.456
71818704|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.5|STANDARD_ERROR_OF_MEAN|7.27||0.966|TWO_SIDED|95.0|-19.5|4.4|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A + B + C)||4.4|-19.5|0.966
71818705|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-13.3|STANDARD_ERROR_OF_MEAN|4.93||0.275|TWO_SIDED|95.0|-21.4|-5.2|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.2|-21.4|0.275
71818706|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline to Week 12 (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-11.8|STANDARD_ERROR_OF_MEAN|3.56||0.304|TWO_SIDED|95.0|-17.6|-5.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A + B + C)||-5.9|-17.6|0.304
71818707|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B) FAS|LS Mean change|-17.1|STANDARD_ERROR_OF_MEAN|4.45||0.057|TWO_SIDED|95.0|-24.5|-9.8|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A + B + C)||-9.8|-24.5|0.057
71818708|NCT02855164|143140639|SUPERIORITY|Repeated measures analysis: ALT (U/L) change from baseline up to EOT (Parts A + B + C) FAS|LS Mean change|-23.0|STANDARD_ERROR_OF_MEAN|4.49||0.003|TWO_SIDED|95.0|-30.5|-15.6|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A + B + C)||-15.6|-30.5|0.003
71818709|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-9.9|STANDARD_ERROR_OF_MEAN|6.56||0.722|TWO_SIDED|95.0|-22.9|3.0|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Part A)||3.0|-22.9|0.722
71818710|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Full analysis set)|LS Mean change|-2.2|STANDARD_ERROR_OF_MEAN|5.96||0.468|TWO_SIDED|95.0|-14.0|9.5|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Part A)||9.5|-14.0|0.468
71818711|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-8.8|STANDARD_ERROR_OF_MEAN|3.97||0.774|TWO_SIDED|95.0|-16.7|-1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B)||-1.0|-16.7|0.774
71818712|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.6|STANDARD_ERROR_OF_MEAN|2.76||0.136|TWO_SIDED|95.0|-6.0|4.9|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B)||4.9|-6.0|0.136
71850311|NCT01250717|143214074|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|0.12||||||||0.12|0|
71900747|NCT04598165|143323064|SUPERIORITY||Risk Ratio (RR)|1.14||||0.751|TWO_SIDED|95.0|0.5|2.61||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.53 in provision of Kangaroo Mother Care assuming 25% in controls.||2.61|0.50|0.751
71900748|NCT04598165|143323065|SUPERIORITY||Risk Ratio (RR)|1.0||||0.431|TWO_SIDED|95.0|1.0|1.01||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.04 in number of danger signs correctly named assuming median of 3 in controls.||1.01|1.00|0.431
71818713|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-16.0|STANDARD_ERROR_OF_MEAN|3.97||0.145|TWO_SIDED|95.0|-23.9|-8.2|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Part C)||-8.2|-23.9|0.145
71818714|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Part C) (Full analysis set)|LS Mean change|-15.3|STANDARD_ERROR_OF_MEAN|4.49||0.236|TWO_SIDED|95.0|-24.2|-6.4|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Part C)||-6.4|-24.2|0.236
71818715|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-7.1|STANDARD_ERROR_OF_MEAN|7.0||0.788|TWO_SIDED|95.0|-18.7|4.4|||ANCOVA|||10 micrograms of Tropifexor vs placebo (Parts A+B+ C)||4.4|-18.7|0.788
71900749|NCT04598165|143323066|SUPERIORITY||Risk Ratio (RR)|1.03||||0.321|TWO_SIDED|95.0|0.98|1.08||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson regression||SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 1.11 in appropriate care seeking assuming 1 clinic visit in the 6-weeks postpartum for controls.||1.08|0.98|0.321
71900750|NCT04598165|143323067|SUPERIORITY||Risk Ratio (RR)|1.01||||0.65|TWO_SIDED|95.0|0.98|1.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Poisson generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator.|We estimated a sample size of 5000 to detect a risk ratio of ≤0.53 assuming a neonatal mortality rate of 23 per 1000 in the control arm with 80% power and, 95% confidence and assuming 10% attrition. With this sample size, assuming alpha=0.0045 (Bonferroni adjusted for 11 tests), we also had 80% power to detect a risk ratio of 0.76 in elevated depression symptoms assuming 19% in controls.||1.04|0.98|0.650
71900751|NCT04598165|143323068|SUPERIORITY||Coefficient|0.09||||0.071|TWO_SIDED|95.0|-0.007|0.18||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.18|-0.007|0.071
71900752|NCT04598165|143323069|SUPERIORITY||Coefficient|0.02||||0.19|TWO_SIDED|95.0|-0.01|0.04||The intention to treat analysis was adjusted for differences in exposure to other SMS programs and phone ownership. We corrected for multiple comparisons using the Benjamini-Hochberg method. The threshold for statistical significance was p=0.05.|Linear generalized estimating equations||n (%) are values at 6-week visit, and RR compares change over time for enrollment, 2- and 6-week visits. SMS group is the numerator. Coefficient (95% CI) for linear GEE using enrollment, 2- and 6-week visits.|||0.04|-0.01|0.190
71900753|NCT01323673|143323070|SUPERIORITY_OR_OTHER|||||||0.151||95.0||||Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.|Cochran-Mantel-Haenszel|||||||0.151
71900754|NCT00426751|143323078|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.|Median Difference (Final Values)|2.1||||||90.0|-8.5|12.8||||||||12.8|-8.5|
71900755|NCT00426751|143323079|NON_INFERIORITY_OR_EQUIVALENCE|For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.|Mean Difference (Final Values)|6.8||||||95.0|-3.0|16.6|||||Analysis based on the ITT population confirmed the results observed in the PP population.|||16.6|-3.0|
71900756|NCT04657016|143323122|SUPERIORITY||Mean Difference (Net)|-24.5|||<|0.001|TWO_SIDED|95.0|-26.1|-22.8|||Mixed Models Analysis|||||-22.8|-26.1|<0.001
71900757|NCT04657016|143323123|SUPERIORITY||Odds Ratio (OR)|130.36|||<|0.001|TWO_SIDED|95.0|69.98|242.84|||Regression, Logistic|||||242.84|69.98|<0.001
71900758|NCT04657016|143323124|SUPERIORITY||Odds Ratio (OR)|101.6|||<|0.001|TWO_SIDED|95.0|39.17|263.55|||Regression, Logistic|||||263.55|39.17|<0.001
71900759|NCT04657016|143323125|SUPERIORITY||Odds Ratio (OR)|153.95|||<|0.001|TWO_SIDED|95.0|78.9|300.37|||Regression, Logistic|||||300.37|78.90|<0.001
71818716|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|0.4|STANDARD_ERROR_OF_MEAN|6.43||0.413|TWO_SIDED|95.0|-10.2|11.0|||ANCOVA|||30 micrograms of Tropifexor vs placebo (Parts A+B+ C)||11.0|-10.2|0.413
71900760|NCT04657016|143323126|SUPERIORITY||Odds Ratio (OR)|144.48|||<|0.001|TWO_SIDED|95.0|62.65|333.21|||Regression, Logistic|||||333.21|62.65|<0.001
71900761|NCT04657016|143323127|SUPERIORITY||Odds Ratio (OR)|118.06|||<|0.001|TWO_SIDED|95.0|40.08|347.74|||Regression, Logistic|||||347.74|40.08|<0.001
71900762|NCT04657016|143323128|SUPERIORITY||Mean Difference (Net)|-17.9|||<|0.001|TWO_SIDED|95.0|-19.5|-16.3|||Mixed Models Analysis|||||-16.3|-19.5|<0.001
71900763|NCT04657016|143323129|SUPERIORITY||Mean Difference (Net)|-25.0|||<|0.001|TWO_SIDED|95.0|-26.9|-23.2|||Mixed Models Analysis|||||-23.2|-26.9|<0.001
71900764|NCT04657016|143323130|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-9.6|-8.3|||Mixed Models Analysis|||||-8.3|-9.6|<0.001
71900765|NCT04657016|143323131|SUPERIORITY||Mean Difference (Net)|-10.2|||<|0.001|TWO_SIDED|95.0|-12.2|-8.1|||Mixed Models Analysis|||||-8.1|-12.2|<0.001
71900766|NCT04657016|143323132|SUPERIORITY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|95.0|-7.2|-4.3|||Mixed Models Analysis|||||-4.3|-7.2|<0.001
71900767|NCT04657016|143323133|SUPERIORITY||Mean Difference (Net)|-7.79|STANDARD_ERROR_OF_MEAN|1.348|<|0.001|TWO_SIDED|95.0|-10.4|-5.1|||Mixed Models Analysis|||||-5.10|-10.40|<0.001
71900768|NCT04657016|143323134|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|8.2|14.7|||Mixed Models Analysis|||||14.7|8.2|<0.001
71900769|NCT04657016|143323135|SUPERIORITY||Mean Difference (Net)|-11.5|STANDARD_ERROR_OF_MEAN|1.97|<|0.001|TWO_SIDED|95.0|-15.3|-7.53|||Mixed Models Analysis|||||-7.53|-15.30|<0.001
71900770|NCT04657016|143323136|SUPERIORITY||Mean Difference (Net)|-27.8|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-32.1|-23.2|||Mixed Models Analysis|||||-23.2|-32.1|<0.001
71900771|NCT04657016|143323137|SUPERIORITY||Mean Difference (Net)|-28.0|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-32.3|-23.4|||Mixed Models Analysis|||||-23.4|-32.3|<0.001
71900772|NCT04657016|143323138|SUPERIORITY||Mean Difference (Net)|-21.3|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-28.4|-13.6|||Mixed Models Analysis|||||-13.6|-28.4|<0.001
71900773|NCT04657016|143323139|SUPERIORITY||Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-13.5|-8.8|||Mixed Models Analysis|||||-8.8|-13.5|<0.001
71900774|NCT04657016|143323140|SUPERIORITY||Mean Difference (Net)|-0.47|||<|0.001|TWO_SIDED|95.0|-0.53|-0.42|||Mixed Models Analysis|||||-0.42|-0.53|<0.001
71900775|NCT04657016|143323141|SUPERIORITY||Mean Difference (Net)|-48.1|STANDARD_ERROR_OF_MEAN|3.04|<|0.001|TWO_SIDED|95.0|-53.7|-41.7|||Mixed Models Analysis|||||-41.7|-53.7|<0.001
71900776|NCT04657016|143323142|SUPERIORITY||Mean Difference (Net)|3.8|||<|0.001|TWO_SIDED|95.0|2.8|4.9|||ANCOVA|||||4.9|2.8|<0.001
71900777|NCT04657016|143323143|SUPERIORITY||Mean Difference (Net)|12.8|||<|0.001|TWO_SIDED|95.0|9.7|16.0|||ANCOVA|||||16.0|9.7|<0.001
71818717|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-6.2|STANDARD_ERROR_OF_MEAN|4.38||0.833|TWO_SIDED|95.0|-13.4|1.0|||ANCOVA|||60 micrograms of Tropifexor vs placebo (Parts A+B+ C)||1.0|-13.4|0.833
71818718|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|2.0|STANDARD_ERROR_OF_MEAN|3.19||0.068|TWO_SIDED|95.0|-3.2|7.3|||ANCOVA|||90 micrograms of Tropifexor vs placebo (Parts A+B+ C)||7.3|-3.2|0.068
71818719|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-0.1|STANDARD_ERROR_OF_MEAN|3.98||0.269|TWO_SIDED|95.0|-6.6|6.5|||ANCOVA|||140 micrograms of Tropifexor vs placebo (Parts A+B+ C)||6.5|-6.6|0.269
71818720|NCT02855164|143140640|SUPERIORITY|Repeated measures analysis: AST (U/L) change from baseline up to EOT (Parts A+B+C) Full analysis set (FAS)|LS Mean change|-3.8|STANDARD_ERROR_OF_MEAN|4.05||0.777|TWO_SIDED|95.0|-10.5|2.9|||ANCOVA|||200 micrograms of Tropifexor vs placebo (Parts A+B+ C)||2.9|-10.5|0.777
71818721|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-7.48|STANDARD_ERROR_OF_MEAN|6.174||0.853|TWO_SIDED|95.0|-19.66|4.7|||ANCOVA|||10 microgramsof Tropifexor - Change in percentage of fat in the liver Part A||4.70|-19.66|0.853
71818722|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-14.07|STANDARD_ERROR_OF_MEAN|5.661||0.232|TWO_SIDED|95.0|-25.24|-2.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Part A||-2.91|-25.24|0.232
71818723|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-15.04|STANDARD_ERROR_OF_MEAN|3.754||0.077|TWO_SIDED|95.0|-22.45|-7.64|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.64|-22.45|0.077
71818724|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline|LS Mean change|-12.34|STANDARD_ERROR_OF_MEAN|2.482||0.141|TWO_SIDED|95.0|-17.23|-7.44|||ANCOVA|||90 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B||-7.44|-17.23|0.141
71850312|NCT05066230|143214084|SUPERIORITY||Difference of weighted percentages|39.7|||<|0.0001|TWO_SIDED|95.02|31.3|48.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||48.1|31.3|<0.0001
71850313|NCT05066230|143214085|SUPERIORITY||Difference of weighted percentages|-18.7|||<|0.0001|TWO_SIDED|95.02|-26.2|-11.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-11.2|-26.2|<0.0001
71850314|NCT05066230|143214086|SUPERIORITY||Difference of weighted percentages|5.6||||0.0058|TWO_SIDED|95.02|1.6|9.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53), HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||9.5|1.6|0.0058
71850315|NCT05066230|143214087|SUPERIORITY||Difference of weighted percentages|-6.5||||0.0149|TWO_SIDED|95.02|-11.8|-1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by baseline DRSS level (≤level 47 vs. ≥level 53) and HbA1c level (≤8.5% vs. \>8.5%).|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||-1.3|-11.8|0.0149
71850316|NCT02164578|143214099|SUPERIORITY|||||||0.004|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||The hypothesis H0 is tested against the one-sided alternative hypothesis H1 H0: µ∆FBF,Riva, week 20 ≤ µ∆FBF, ASA, week 20 versus H1: µΔFBF, Riva, week 20 \> µΔFBF, ASA, week 20 by test procedures for continuous data.||||0.004
71850317|NCT02164578|143214100|OTHER|||||||0.07|||||||ANCOVA|||||||0.070
71850318|NCT02164578|143214101|OTHER|||||||0.045|||||||ANCOVA|ANCOVA for repeated measurements with baseline as covariate||||||0.045
71850319|NCT02164578|143214102|OTHER|||||||0.125|||||||ANCOVA|||||||0.125
71850320|NCT02164578|143214103|OTHER|||||||0.217|||||||Wilcoxon (Mann-Whitney)|||||||0.217
71850321|NCT02164578|143214104|OTHER|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
71850322|NCT02507297|143214109|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.367
71850323|NCT02507297|143214109|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.48
71850324|NCT02507297|143214110|SUPERIORITY|||||||0.136|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.136
71850325|NCT02507297|143214110|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.324
71850326|NCT02507297|143214111|SUPERIORITY|||||||0.916|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.916
71850327|NCT02507297|143214111|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.752
71850328|NCT02507297|143214112|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 8 weeks after baseline||||.568
71850329|NCT02507297|143214112|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Baseline to 12 weeks postpartum||||.568
71850330|NCT02507297|143214113|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||||||.486
71850331|NCT03740737|143214153|OTHER||Treatment difference|63.0|||<|0.001|TWO_SIDED|95.0|55.5|67.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|||67.1|55.5|<0.001
71850332|NCT03740737|143214154|OTHER||Treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|22.5|33.7|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Ongoing Pregnancy Rate in the Fresh Cycle||33.7|22.5|<0.001
71850333|NCT03740737|143214158|OTHER||Treatment difference|31.8|||<|0.001|TWO_SIDED|95.0|24.7|36.0|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate in the fresh cycle||36.0|24.7|<0.001
71850334|NCT03740737|143214158|OTHER||Treatment difference|68.2|||<|0.001|TWO_SIDED|95.0|61.2|72.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Clinical pregnancy rate cumulatively||72.1|61.2|<0.001
71900778|NCT03470922|143323151|SUPERIORITY||Cox Proportional Hazard|0.75||||0.0055|TWO_SIDED|95.0|0.62|0.92|||Log Rank|Log-rank test stratified by LAG-3 (≥ 1% vs \< 1%), BRAF (mutation positive vs mutation wild-type), AJCC M-stage (M0/M1any\[0\] vs M1any\[1\])||||0.92|0.62|0.0055
71900779|NCT02361762|143323184|OTHER|||||||0.36|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.36
71900780|NCT02361762|143323185|OTHER|||||||0.79|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.79
71900781|NCT02361762|143323186|OTHER|||||||0.009|||||||ANOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Congruent/Incongruent)||||||0.009
71900782|NCT02361762|143323187|OTHER|||||||0.79||||||ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|ANCOVA|Compared scores at post testing with baseline scores covaried.||||||.79
71900783|NCT02361762|143323188|OTHER|||||||0.61|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.61
71900784|NCT02361762|143323189|OTHER|||||||0.68|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)0.||||||0.68
71900785|NCT02361762|143323190|OTHER|||||||0.54|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.54
71900786|NCT02361762|143323191|OTHER|||||||0.08|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.08
71900787|NCT02361762|143323192|OTHER|||||||0.37|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.37
71900788|NCT02361762|143323194|OTHER|||||||0.62|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.62
71900789|NCT02361762|143323195|OTHER|||||||0.1|||||||ANCOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Go/Nogo)||||||0.10
71900790|NCT02361762|143323196|OTHER|||||||0.02|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)||||||0.02
71900791|NCT04467164|143323244|SUPERIORITY|||||||0.03|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the subgenual anterior cingulate cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.03
71679534|NCT02612610|142877081|OTHER||LS Mean Difference|-15.9||||0.0003|TWO_SIDED|95.0|-24.3|-7.5|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-7.5|-24.3|0.0003
71900792|NCT04467164|143323244|SUPERIORITY|||||||0.022|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the orbitofrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.022
71900793|NCT04467164|143323244|SUPERIORITY|||||||0.027|||||||ANCOVA|||The null hypothesis is that there were no differences in change of brain activity in the ventromedial prefrontal cortex (fMRI BOLD signal) between exhalatory-gated and inhalatory-gated tVNS. An ANCOVA model was used with average beta weights in response to stress task at baseline as a covariate. The test was performed with a significance level of 0.05 (two-sided).||||0.027
71900794|NCT04467164|143323245|SUPERIORITY|||||||0.03|||||||ANOVA|||Null hypothesis is that there was no difference in the change in BDI scale score between exhalatory-gated tVNS and inhalatory-gated tVNS. A repeated measures ANOVA controlled by baseline values was used to test this difference. A p\<0.05 was designated for statistical significance. A positive difference indicates an increase in depressive symptomatology, whereas a negative difference indicates a reduction in depressive symptoms.||||0.03
71900795|NCT04467164|143323246|SUPERIORITY|||||||0.01|||||||Regression, Linear|||The null hypothesis is that there were no differences in percent HFn changes post-pre stimulation between exhalatory-gated and inhalatory-gated tVNS. A General Linear Model (GLM) analysis adjusted by baseline values was used for evaluating differences in this measure between treatment groups. A p\<0.05 was designated for statistical significance. A positive percent change value indicates an increase in cardiovagal activity, whereas a negative change indicates a reduction in cardiovagal activity.||||0.01
71900796|NCT02369835|143323247|OTHER|||||||0.8872|||||||Chi-squared|||||||.8872
71900797|NCT01703286|143323268|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5403|TWO_SIDED|90.0|0.633|1.235|||ANOVA|||||1.235|0.633|0.5403
71900798|NCT01703286|143323268|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|0.884||||0.5402|TWO_SIDED|90.0|0.632|1.235|||ANOVA|||||1.235|0.632|0.5402
71900799|NCT01703286|143323268|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.0||||0.9989|TWO_SIDED|90.0|0.715|1.397|||ANOVA|||||1.397|0.715|0.9989
71900800|NCT01703286|143323269|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.208||||0.3885|TWO_SIDED|90.0|0.84|1.738|||ANOVA|||||1.738|0.840|0.3885
71900801|NCT01703286|143323269|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.251||||0.3105|TWO_SIDED|90.0|0.868|1.801|||ANOVA|||||1.801|0.868|0.3105
71900802|NCT01703286|143323269|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|1.035||||0.8749|TWO_SIDED|90.0|0.721|1.485|||ANOVA|||||1.485|0.721|0.8749
71900803|NCT01703286|143323270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.048||0.2982|TWO_SIDED|90.0|-0.13|0.03|||ANOVA|||||0.030|-0.130|0.2982
71900804|NCT01703286|143323270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.021|STANDARD_ERROR_OF_MEAN|0.048||0.6601|TWO_SIDED|90.0|-0.059|0.101|||ANOVA|||||0.101|-0.059|0.6601
71900805|NCT01703286|143323270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.072|STANDARD_ERROR_OF_MEAN|0.048||0.1412|TWO_SIDED|90.0|-0.009|0.152|||ANOVA|||||0.152|-0.009|0.1412
71818725|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12|LS Mean change|-31.25|STANDARD_ERROR_OF_MEAN|5.228|<|0.001|TWO_SIDED|95.0|-41.58|-20.92|||ANCOVA|||140 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-20.92|-41.58|<0.001
71818726|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-39.54|STANDARD_ERROR_OF_MEAN|4.968|<|0.001|TWO_SIDED|95.0|-49.37|-29.71|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Part C||-29.71|-49.37|<0.001
71818727|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-8.09|STANDARD_ERROR_OF_MEAN|6.65||0.872|TWO_SIDED|95.0|-19.06|2.88|||ANCOVA|||10 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||2.88|-19.06|0.872
71850335|NCT03740737|143214159|OTHER||Treatment difference|30.5|||<|0.001|TWO_SIDED|95.0|23.4|34.6|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate in the fresh cycle||34.6|23.4|<0.001
71850336|NCT03740737|143214159|OTHER||Treatment difference|65.1|||<|0.001|TWO_SIDED|95.0|57.5|69.1|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Vital pregnancy rate cumulatively||69.1|57.5|<0.001
71850337|NCT03740737|143214161|OTHER||Treatment difference|35.0|||<|0.001|TWO_SIDED|95.0|28.1|39.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate in the fresh cycle||39.2|28.1|<0.001
71850338|NCT03740737|143214161|OTHER||Treatment difference|72.4|||<|0.001|TWO_SIDED|95.0|65.3|76.2|||Fisher Exact||95% exact Agresti-Min confidence intervals.|Positive βhCG rate cumulatively||76.2|65.3|<0.001
71850339|NCT03740737|143214173|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71850340|NCT03740737|143214174|OTHER||||||<|0.001|||||||Wilcoxon rank sum test|||||||<0.001
71850341|NCT03740737|143214175|OTHER|||||||0.22|||||||Fisher Exact|||||||0.220
71850342|NCT03740737|143214176|OTHER|||||||0.588|||||||Fisher Exact|||||||0.588
71850343|NCT01286311|143214223|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.54|1.86|||Generalized Logistic Regression|||||1.86|0.54|0.99
71850344|NCT01286311|143214224|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.27|TWO_SIDED|95.0|0.84|1.85|||Generalized Logistic Regression|||||1.85|0.84|0.27
71850345|NCT01286311|143214225|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.038|TWO_SIDED|95.0|1.05|4.32|||Generalized Logistic Regression|||||4.32|1.05|0.038
71850346|NCT01286311|143214226|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.72||||0.13|TWO_SIDED|95.0|0.73|10.1|||Generalized Logistic Regression|||||10.1|0.73|0.13
71850347|NCT01286311|143214227|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.3|TWO_SIDED|95.0|0.5|9.5|||Generalized Logistic Regression|||||9.5|0.50|0.30
71850348|NCT03034863|143214228|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.03|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
71850349|NCT03034863|143214229|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.69
71850350|NCT03034863|143214230|SUPERIORITY|||||||0.49||||||All p-values are two-tailed|Fisher Exact|Compares veterans who reported 1+ attempts at any follow-up wave out of total number of veterans in each group (i.e., 0/19 for SAFER; 2/20 for I-SPI).||||||.49
71850351|NCT03034863|143214231|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
71850352|NCT03034863|143214232|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.87|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.87
71850353|NCT03034863|143214233|SUPERIORITY||Slope|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.03
71818728|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-14.14|STANDARD_ERROR_OF_MEAN|6.198||0.465|TWO_SIDED|95.0|-24.36|-3.91|||ANCOVA|||30 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-3.91|-24.36|0.465
71882305|NCT01732796|143283466|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|10.8||||0.004|TWO_SIDED|95.0|2.8|18.8|||z-test|based on two sample z-test with continuity correction for variance.||||18.8|2.8|0.0040
71882306|NCT01732796|143283467|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|6.0||||0.0575|TWO_SIDED|95.0|-1.5|13.5|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||13.5|-1.5|0.0575
71882307|NCT01732796|143283468|SUPERIORITY_OR_OTHER||Koch's method with continuity correction|9.9||||0.0089|TWO_SIDED|95.0|1.7|18.1|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response||18.1|1.7|0.0089
71882308|NCT01757678|143283471|OTHER||Difference in Probability|0.14|||||TWO_SIDED|95.0|0.09|0.19||||||||.19|.09|
71882309|NCT01757678|143283472|OTHER||Difference in Probability|0.09|||||TWO_SIDED|95.0|0.04|0.14||||||||.14|.04|
71882310|NCT03972969|143283477|SUPERIORITY||Incidence Rate Ratio|0.13|||<|0.05|TWO_SIDED|95.0|0.05|0.32|||negative binomial regression|||||0.32|0.05|<0.05
71818729|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-15.02|STANDARD_ERROR_OF_MEAN|4.078||0.228|TWO_SIDED|95.0|-21.75|-8.29|||ANCOVA|||60 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-8.29|-21.75|0.228
71882311|NCT03972969|143283477|SUPERIORITY||Incidence Rate Ratio|0.25|||<|0.05|TWO_SIDED|95.0|0.1|0.61|||negative binomial regression|||||0.61|0.10|<0.05
71882312|NCT03972969|143283477|SUPERIORITY||Incidence Rate Ratio|0.52|||<|0.05|TWO_SIDED|95.0|0.19|1.38|||negative binomial regression|||||1.38|0.19|<0.05
71882313|NCT03972969|143283478|SUPERIORITY||Incidence Rate Ratio|0.15|||<|0.05|TWO_SIDED|95.0|0.07|0.33|||negative binomial regression|||||0.33|0.07|<0.05
71818730|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-12.56|STANDARD_ERROR_OF_MEAN|2.717||0.37|TWO_SIDED|95.0|-17.04|-8.08|||ANCOVA|||90 micrograms - Change in percentage of fat in the liver Parts A+B+C||-8.08|-17.04|0.370
71818731|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-18.71|STANDARD_ERROR_OF_MEAN|3.517||0.029|TWO_SIDED|95.0|-24.51|-12.91|||ANCOVA|||140 micrograms - Change in percentage of fat in the liver Parts A+B+C||-12.91|-24.51|0.029
71818732|NCT02855164|143140641|SUPERIORITY|ANCOVA: Relative change in percentage of fat in the liver from baseline to Week 12 (Parts A+B+C)|LS Mean change|-34.38|STANDARD_ERROR_OF_MEAN|3.482|<|0.001|TWO_SIDED|95.0|-40.13|-28.64|||ANCOVA|||200 micrograms of Tropifexor - Change in percentage of fat in the liver Parts A+B+C||-28.64|-40.13|<0.001
71882314|NCT03972969|143283478|SUPERIORITY||Incidence Rate Ratio|0.26|||<|0.05|TWO_SIDED|95.0|0.11|0.58|||negative binomial regression|||||0.58|0.11|<0.05
71882315|NCT03972969|143283478|SUPERIORITY||Incidence Rate Ratio|0.58|||<|0.05|TWO_SIDED|95.0|0.25|1.38|||negative binomial regression|||||1.38|0.25|<0.05
71882316|NCT01074190|143283482|SUPERIORITY|||||||0.34|||||||Chi-squared|||||||.34
71900806|NCT01984346|143323272|SUPERIORITY||Mean Difference (Net)|16.7||||0.0472|TWO_SIDED|95.0|0.1|33.2||A prior threshold for statistical significance was 0.05|Chi-square test|||||33.2|0.1|0.0472
71900807|NCT01234402|143323286|OTHER||Hazard Ratio (HR)|0.691||||0.1315|TWO_SIDED|95.0|0.429|1.114|||Log Rank|||Kaplan-Meier methodology estimated median PFS||1.114|0.429|0.1315
71679535|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1387|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1387
71679536|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7238|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7238
71679537|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0144|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0144
71679538|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0922|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0922
71679539|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3812|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3812
71679540|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0088
71679541|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0653|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0653
71679542|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6443|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6443
71679543|NCT02612610|142877082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1511
71679544|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0045
71818733|NCT02855164|143140642|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.79|STANDARD_ERROR_OF_MEAN|0.608||0.01|TWO_SIDED|95.0|-2.99|0.59|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.59|-2.99|0.010
71818734|NCT02855164|143140642|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-0.78|STANDARD_ERROR_OF_MEAN|0.567||0.237|TWO_SIDED|95.0|-1.9|0.34|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.34|-1.90|0.237
71882317|NCT01074190|143283483|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.1
71882318|NCT01074190|143283484|SUPERIORITY|||||||0.1|||||||Chi-squared|||A sample size of 315 achieves 80% power to detect a difference among groups using a 2 degrees of freedom Chi-Square Test with a significance level (alpha) of 0.05.||||.1
71882319|NCT01500278|143283493|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|||=|0.467|TWO_SIDED|95.0|0.67|1.2||The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and age as a covariate.|Regression, Logistic|||||1.20|0.67|=0.467
71900808|NCT01234402|143323286|OTHER||Hazard Ratio (HR)|1.48||||0.0851|TWO_SIDED|95.0|0.938|2.335|||Log Rank|||Kaplan-Meier methodology estimated median PFS||2.335|0.938|0.0851
71900809|NCT01234402|143323287|OTHER||Hazard Ratio (HR)|1.833||||0.0283|TWO_SIDED|95.0|1.06|3.169|||Log Rank|||||3.169|1.060|0.0283
71818735|NCT02855164|143140642|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.05|STANDARD_ERROR_OF_MEAN|0.377||0.037|TWO_SIDED|95.0|-1.8|0.31|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.31|-1.80|0.037
71818736|NCT02855164|143140642|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts A + B) (Full analysis set)|LS Mean change|-1.15|STANDARD_ERROR_OF_MEAN|0.253||0.007|TWO_SIDED|95.0|-1.65|0.65|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.65|-1.65|0.007
71818737|NCT02855164|143140642|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.1|STANDARD_ERROR_OF_MEAN|0.988||0.053|TWO_SIDED|95.0|-7.05|-3.14|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-3.14|-7.05|0.053
71818738|NCT02855164|143140642|SUPERIORITY|Repeated measures analysis: Change in weight from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-5.89|STANDARD_ERROR_OF_MEAN|1.002||0.013|TWO_SIDED|95.0|-7.87|-3.91|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-3.91|-7.87|0.013
71818739|NCT02855164|143140643|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.64|STANDARD_ERROR_OF_MEAN|0.208||0.006|TWO_SIDED|95.0|-1.05|0.23|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.23|-1.05|0.006
71818740|NCT02855164|143140643|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.29|STANDARD_ERROR_OF_MEAN|0.194||0.177|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.09|-0.67|0.177
71818741|NCT02855164|143140643|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-0.35|STANDARD_ERROR_OF_MEAN|0.129||0.032|TWO_SIDED|95.0|-0.61|0.1|||Mixed Models Analysis|||60 micrograms of Tropifexor (Parts A + B) vs Placebo||0.10|-0.61|0.032
71818742|NCT02855164|143140643|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-0.42|STANDARD_ERROR_OF_MEAN|0.087||0.003|TWO_SIDED|95.0|-0.59|0.25|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.25|-0.59|0.003
71818743|NCT02855164|143140643|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Full analysis set)|LS Mean change|-1.88|STANDARD_ERROR_OF_MEAN|0.322||0.015|TWO_SIDED|95.0|-2.51|-1.24|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||-1.24|-2.51|0.015
71850354|NCT03034863|143214234|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.16|TWO_SIDED||||||Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
71850355|NCT03034863|143214235|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.35||0.81|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.81
71850356|NCT03034863|143214236|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.62||0.55|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.55
71850357|NCT03034863|143214237|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.64|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.64
71850358|NCT03034863|143214238|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.62|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.62
71850359|NCT03034863|143214239|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.16|TWO_SIDED|||||All p-values are two-tailed|Hierarchical Linear Modeling/MLM|Hypothesis tested using a dummy code representing group assignment (1=SAFER; 0=I-SPI) in the Level 2 equation for the slope term.|Slope represents relative unit change/month between both conditions. Positive slope terms represent relative increases in SAFER compared to I-SPI. Negative slope terms represent relative reductions in SAFER compared to I-SPI.|||||.16
71850360|NCT03403153|143214327|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<0.01
71818744|NCT02855164|143140643|SUPERIORITY|Repeated measures analysis: Change in BMI from baseline to EOT (Parts C) (Full analysis set)|LS Mean change|-2.11|STANDARD_ERROR_OF_MEAN|0.327||0.004|TWO_SIDED|95.0|-2.75|-1.46|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||-1.46|-2.75|0.004
71850361|NCT03403153|143214328|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71850362|NCT03403153|143214329|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71818745|NCT02855164|143140644|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.009||0.53|TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis|||10 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.03|0.530
71818746|NCT02855164|143140644|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.008||0.857|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||30 micrograms of Tropifexor (Part A) vs Placebo||0.01|-0.02|0.857
71850363|NCT03403153|143214330|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71850364|NCT03403153|143214331|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71679545|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0947|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0947
71850365|NCT03403153|143214332|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71679546|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0080
71900810|NCT01234402|143323287|OTHER||Hazard Ratio (HR)|1.468||||0.155|TWO_SIDED|95.0|0.862|2.501|||Log Rank|||||2.501|0.862|0.1550
71900811|NCT01234402|143323288|OTHER|||||||0.6691|||||||Fisher Exact|||||||0.6691
71900812|NCT01234402|143323288|OTHER|||||||0.1743|||||||Fisher Exact|||||||0.1743
71818747|NCT02855164|143140644|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.005||0.262|TWO_SIDED|95.0|-0.02|0.0|||Mixed Models Analysis|||60 micrograms of Tropifexor (Part A) vs Placebo||0.00|-0.02|0.262
71818748|NCT02855164|143140644|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Parts A+B) (Full analysis set)|LS Mean change|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.323|TWO_SIDED|95.0|0.0|0.01|||Mixed Models Analysis|||90 micrograms of Tropifexor (Parts A + B) vs Placebo||0.01|0.00|0.323
71818749|NCT02855164|143140644|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|0.01|STANDARD_ERROR_OF_MEAN|0.008||0.1|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||140 micrograms of Tropifexor (Part C) vs Placebo||0.01|-0.02|0.100
71818750|NCT02855164|143140644|SUPERIORITY|Repeated measures analysis: Change in WTH ratio from baseline to EOT (Part C) (Full analysis set)|LS Mean change|-0.01|STANDARD_ERROR_OF_MEAN|0.007||0.693|TWO_SIDED|95.0|-0.03|0.0|||Mixed Models Analysis|||200 micrograms of Tropifexor (Part C) vs Placebo||0.00|-0.03|0.693
71818751|NCT02855164|143140656|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.223|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.223|-0.214|1.0000
71850366|NCT03403153|143214333|OTHER||||||<|0.01|||||||t-test, 1 sided|||||||<.01
71850367|NCT03875729|143214386|SUPERIORITY||Mean Difference (Net)|0.1253|||<|0.001|TWO_SIDED|95.0|0.0852|0.1653||ITT: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = Teplizumab - Placebo|This study was designed to show a difference of at least a 40% in C-peptide response between teplizumab and placebo. In geometric means, this translates to a value of (1.4×0.28) = 0.392. Consequently, approximately 300 participants were planned for enrollment, assuming 2-sided α=0.05, 90% power, 2:1 randomization, and a 10% dropout rate.||0.1653|0.0852|<0.001
71850368|NCT03875729|143214386|SUPERIORITY||Mean Difference (Net)|0.1385|||<|0.001|TWO_SIDED|95.0|0.0994|0.1776||PP: The ANCOVA model included treatment, age group at randomization, and baseline C-peptide ln(AUC+1) as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||Least squares mean (LSmean) difference = teplizumab - placebo|||0.1776|0.0994|<0.001
71850369|NCT03875729|143214387|SUPERIORITY||Mean Difference (Final Values)|-0.131||||0.085|TWO_SIDED|95.0|-0.28|0.018||ITT: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.018|-0.280|0.085
71850370|NCT03875729|143214387|SUPERIORITY||Mean Difference (Final Values)|-0.167|||<|0.001|TWO_SIDED|95.0|-0.256|-0.078||PP: ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data at Week 78 were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||-0.078|-0.256|<0.001
71850371|NCT03875729|143214388|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.606|TWO_SIDED|95.0|-0.42|0.24||ITT: ANCOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA|||||0.24|-0.42|0.606
71850372|NCT03875729|143214388|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.454|TWO_SIDED|95.0|-0.46|0.2||PP: ANOVA model included treatment, age group at randomization, screening peak C-peptide category, baseline HbA1c as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||0.20|-0.46|0.454
71850373|NCT03875729|143214389|SUPERIORITY||Mean Difference (Final Values)|4.71||||0.151|TWO_SIDED|95.0|-1.72|11.15||ITT: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||11.15|-1.72|0.151
71900813|NCT00385268|143323299|SUPERIORITY||Odds Ratio (OR)|1.68||||0.44|TWO_SIDED|95.0|0.55|5.14|||GEE model of repeated measures|GEE on repeated binary indicators of BE positive / negative test||||5.14|0.55|0.44
71900814|NCT02389816|143323300|SUPERIORITY||Least square (LS) mean difference|-2.66|STANDARD_ERROR_OF_MEAN|0.999||0.008|TWO_SIDED|95.0|-4.63|-0.7|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-0.70|-4.63|0.0080
71900815|NCT02389816|143323300|SUPERIORITY||LS mean difference|-3.07|STANDARD_ERROR_OF_MEAN|1.003||0.0023|TWO_SIDED|95.0|-5.05|-1.1|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)||||-1.10|-5.05|0.0023
71900816|NCT02389816|143323301|SUPERIORITY||Odds Ratio (OR)|1.621||||0.0341|TWO_SIDED|95.0|1.037|2.533|||Regression, Logistic|||||2.533|1.037|0.0341
71900817|NCT02389816|143323301|SUPERIORITY||Odds Ratio (OR)|1.788||||0.011||95.0|1.143|2.799|||Regression, Logistic|||||2.799|1.143|0.0110
71900818|NCT02389816|143323302|SUPERIORITY||Odds Ratio (OR)|1.839||||0.0186|TWO_SIDED|95.0|1.107|3.054|||Regression, Logistic|||||3.054|1.107|0.0186
71900819|NCT02389816|143323302|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0418|TWO_SIDED|95.0|1.02|2.834|||Regression, Logistic|||||2.834|1.020|0.0418
71900820|NCT02389816|143323303|SUPERIORITY||LS mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.753||0.0165|TWO_SIDED|95.0|-3.29|-0.332|||ANCOVA|||||-0.332|-3.290|0.0165
71900821|NCT02389816|143323303|SUPERIORITY||LS mean difference|-1.79|STANDARD_ERROR_OF_MEAN|0.759||0.019|TWO_SIDED|95.0|-3.278|-0.295|||ANCOVA|||||-0.295|-3.278|0.0190
71818752|NCT02855164|143140656|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (total score)||0.251|-0.196|0.8074
71850374|NCT03875729|143214389|SUPERIORITY||Mean Difference (Final Values)|6.17||||0.045|TWO_SIDED|95.0|0.13|12.22||PP: The ANCOVA model included treatment, age group at randomization, and screening peak C-peptide category as independent variables. Missing data were multiply imputed using a pattern-mixture model under the missing not at random assumption.|ANCOVA||LSmean difference = teplizumab - placebo.|||12.22|0.13|0.045
71818753|NCT02855164|143140657|SUPERIORITY||Risk Difference (RD)|0.028||||0.807|TWO_SIDED|95.0|-0.191|0.246|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.246|-0.191|0.8070
71850375|NCT03875729|143214390|SUPERIORITY||Rate ratio|1.1||||0.634|TWO_SIDED|95.0|0.74|1.64||ITT: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment, age group at randomization, and screening peak C-peptide category as independent variables.|Negative binomial regression model||Rate ratio = teplizumab / placebo.|||1.64|0.74|0.634
71850376|NCT03875729|143214390|SUPERIORITY||Rate ratio|1.09||||0.69|TWO_SIDED|95.0|0.72|1.65||PP: Estimates and p-values were obtained from a negative binomial regression model using rate of hypoglycemic episodes as dependent variable and treatment age group at randomization, and screening peak C-peptide category as independent variables.|Rate ratio||Rate ratio = teplizumab / placebo.|||1.65|0.72|0.690
71850377|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and confidence intervals (CIs) were estimated from an analysis of covariance (ANCOVA) of natural log transformed values.|Ratio|1.89|||||TWO_SIDED|90.0|1.18|3.03|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as a multiplier in the Modified Diet in Renal Disease Study Group (MDRD) equation.|||3.03|1.18|
71818754|NCT02855164|143140657|SUPERIORITY||Risk Difference (RD)|0.052||||0.6233|TWO_SIDED|95.0|-0.173|0.273|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (FDA)||0.273|-0.173|0.6233
71818755|NCT02855164|143140658|SUPERIORITY||Risk Difference (RD)|0.004||||1|TWO_SIDED|95.0|-0.214|0.233|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.233|-0.214|1.0000
71818756|NCT02855164|143140658|SUPERIORITY||Risk Difference (RD)|0.029||||0.8074|TWO_SIDED|95.0|-0.196|0.251|||Mixed Models Analysis|||At least one point improvement in fibrosis (NASH CRN staging) without worsening of steatohepatitis (EMA)||0.251|-0.196|0.8074
71850378|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.27|||||TWO_SIDED|90.0|1.43|3.59|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.59|1.43|
71850379|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.63|||||TWO_SIDED|90.0|1.71|4.06|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.06|1.71|
71850380|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.39|||||TWO_SIDED|90.0|0.888|2.18|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.18|0.888|
71850381|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.94|||||TWO_SIDED|90.0|1.14|3.31|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.31|1.14|
71850382|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.44|||||TWO_SIDED|90.0|1.41|4.22|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.22|1.41|
71850383|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.86|||||TWO_SIDED|90.0|1.74|4.7|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.7|1.74|
71850384|NCT00999336|143214402|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.47|||||TWO_SIDED|90.0|0.944|2.3|||||Statistical comparison of AUC0-24 on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.3|0.944|
71818757|NCT02855164|143140659|SUPERIORITY||Risk Difference (RD)|0.034||||0.7028|TWO_SIDED|95.0|-0.184|0.252|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.252|-0.184|0.7028
71818758|NCT02855164|143140659|SUPERIORITY||Risk Difference (RD)|0.129||||0.1713|TWO_SIDED|95.0|-0.098|0.345|||Mixed Models Analysis|||Resolution of steatohepatitis (diagnostic category) without worsening of fibrosis (NASH CRN staging)||0.345|-0.098|0.1713
71818759|NCT02855164|143140660|SUPERIORITY||Risk Difference (RD)|0.057||||0.2033|TWO_SIDED|95.0|-0.168|0.278|||Mixed Models Analysis|||Resolution of steatohepatitis (FDA, EMA) without worsening of fibrosis (NASH CRN staging)||0.278|-0.168|0.2033
71818760|NCT00383240|143140661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818761|NCT00383240|143140661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818762|NCT00383240|143140661|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818763|NCT00383240|143140661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.491||95.0||||P-Value for Endpoint|ANCOVA|||||||0.491
71818764|NCT00383240|143140661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||P-Value for Endpoint|ANCOVA|||||||0.055
71818765|NCT00383240|143140661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0||||P-Value for Endpoint|ANCOVA|||||||0.008
71818766|NCT00383240|143140662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-Value for Endpoint|ANCOVA|||||||0.174
71818767|NCT00383240|143140662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71900822|NCT02389816|143323304|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0031|TWO_SIDED|95.0|-0.59|-0.121|||ANCOVA|||||-0.121|-0.590|0.0031
71900823|NCT02389816|143323304|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.12||0.0011|TWO_SIDED|95.0|-0.629|-0.158|||ANCOVA|||||-0.158|-0.629|0.0011
71900824|NCT02389816|143323305|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.123||0.0609|TWO_SIDED|95.0|-0.474|0.011|||ANCOVA|||||0.011|-0.474|0.0609
71900825|NCT02389816|143323305|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.124||0.0179|TWO_SIDED|95.0|-0.537|-0.051|||ANCOVA|||||-0.051|-0.537|0.0179
71900826|NCT02389816|143323306|SUPERIORITY||LS mean difference|-1.34|STANDARD_ERROR_OF_MEAN|0.621||0.0311|TWO_SIDED|95.0|-2.564|-0.122|||ANCOVA|||||-0.122|-2.564|0.0311
71900827|NCT02389816|143323306|SUPERIORITY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.628||0.0126|TWO_SIDED|95.0|-2.807|-0.339|||ANCOVA|||||-0.339|-2.807|0.0126
71900828|NCT02389816|143323307|SUPERIORITY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.893||0.3793|TWO_SIDED|95.0|-2.539|0.968|||ANCOVA|||||0.968|-2.539|0.3793
71900829|NCT02389816|143323307|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.891||0.9011|TWO_SIDED|95.0|-1.862|1.641|||ANCOVA|||||1.641|-1.862|0.9011
71900830|NCT02389816|143323308|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.329||0.0089|TWO_SIDED|95.0|-1.512|-0.218|||ANCOVA|||||-0.218|-1.512|0.0089
71900831|NCT02389816|143323308|SUPERIORITY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.332||0.0001|TWO_SIDED|95.0|-1.922|-0.619|||ANCOVA|||||-0.619|-1.922|0.0001
71900832|NCT02417233|143323309|OTHER||Odds Ratio (OR)|0.958||||0.848|TWO_SIDED|95.0|0.62|1.49|||Regression, Logistic|||||1.49|0.62|0.848
71818768|NCT00383240|143140662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818769|NCT00383240|143140662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818770|NCT00383240|143140662|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818771|NCT00383240|143140662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.521||95.0||||P-Value for Endpoint|ANCOVA|||||||0.521
71818772|NCT00383240|143140664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0||||P-Value for Endpoint|ANCOVA|||||||0.026
71818773|NCT00383240|143140664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818774|NCT00383240|143140664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818775|NCT00383240|143140664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818776|NCT00383240|143140664|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818777|NCT00383240|143140664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738||95.0||||P-Value for Endpoint|ANCOVA|||||||0.738
71818778|NCT00383240|143140665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0||||P-Value for endpoint|ANCOVA|||||||0.063
71818779|NCT00383240|143140665|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818780|NCT00383240|143140665|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818781|NCT00383240|143140665|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-Value for Endpoint|ANCOVA|||||||<.001
71818782|NCT00383240|143140665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-Value for Endpoint|ANCOVA|||||||0.003
71818783|NCT00383240|143140665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.601||95.0||||P-Value for Endpoint|ANCOVA|||||||0.601
71818784|NCT01644474|143140675|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.6|||<|0.0001|TWO_SIDED|95.0|-40.2|-23.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-23.0|-40.2|<0.0001
71818785|NCT01644474|143140676|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.5|||<|0.0001|TWO_SIDED|95.0|-35.7|-21.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-21.2|-35.7|<0.0001
71818786|NCT01644474|143140677|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.3|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.3|<0.0001
71818787|NCT01644474|143140678|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.5|||<|0.0001|TWO_SIDED|95.0|-33.5|-17.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17.4|-33.5|<0.0001
71818788|NCT01644474|143140679|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.7|||<|0.0001|TWO_SIDED|95.0|-24.7|-12.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-12.7|-24.7|<0.0001
71818789|NCT01644474|143140680|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.7|||<|0.0001|TWO_SIDED|95.0|-31.5|-19.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.8|-31.5|<0.0001
71818790|NCT01644474|143140681|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.8|||<|0.0001|TWO_SIDED|95.0|-32.4|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-32.4|<0.0001
71818791|NCT01644474|143140682|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.3|||<|0.0001|TWO_SIDED|95.0|-23.1|-13.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.5|-23.1|<0.0001
71818792|NCT01644474|143140683|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|34.8|||<|0.0001|TWO_SIDED|95.0|8.7|139.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||139.0|8.7|<0.0001
71818793|NCT01644474|143140684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|69.8||||0.0001|TWO_SIDED|95.0|8.8|556.0||Threshold for significance was ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||556.0|8.8|0.0001
71818794|NCT01644474|143140685|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4||||0.4013|TWO_SIDED|95.0|-14.8|5.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|-14.8|0.4013
71818795|NCT02023879|143140693|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-56.4|||<|0.0001|TWO_SIDED|95.0|-62.9|-49.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.||-49.9|-62.9|<0.0001
71818796|NCT02023879|143140694|SUPERIORITY_OR_OTHER||LS Mean Difference|-59.7|||<|0.0001|TWO_SIDED|95.0|-65.6|-53.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-53.8|-65.6|<0.0001
71818797|NCT02023879|143140695|SUPERIORITY_OR_OTHER||LS Mean Difference|-44.9|||<|0.0001|TWO_SIDED|95.0|-51.8|-38.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-38.1|-51.8|<0.0001
71818798|NCT02023879|143140696|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.4|||<|0.0001|TWO_SIDED|95.0|-54.8|-41.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.9|-54.8|<0.0001
71818799|NCT02023879|143140697|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-61.1|-49.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-49.8|-61.1|<0.0001
71818800|NCT02023879|143140698|SUPERIORITY_OR_OTHER||LS Mean Difference|-58.6|||<|0.0001|TWO_SIDED|95.0|-63.8|-53.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.4|-63.8|<0.0001
71818801|NCT02023879|143140699|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.4|||<|0.0001|TWO_SIDED|95.0|-52.4|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-40.4|-52.4|<0.0001
71818802|NCT02023879|143140700|SUPERIORITY_OR_OTHER||LS Mean Difference|-48.6|||<|0.0001|TWO_SIDED|95.0|-54.3|-42.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-42.8|-54.3|<0.0001
71818803|NCT02023879|143140701|SUPERIORITY_OR_OTHER||LS Mean Difference|-49.0|||<|0.0001|TWO_SIDED|95.0|-54.9|-43.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.2|-54.9|<0.0001
71818804|NCT02023879|143140702|SUPERIORITY_OR_OTHER||LS Mean Difference|-51.7|||<|0.0001|TWO_SIDED|95.0|-57.1|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.4|-57.1|<0.0001
71818805|NCT02023879|143140703|SUPERIORITY_OR_OTHER||LS Mean Difference|-35.3|||<|0.0001|TWO_SIDED|95.0|-39.8|-30.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.8|-39.8|<0.0001
71818806|NCT02023879|143140704|SUPERIORITY_OR_OTHER||LS Mean Difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-44.3|-32.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.1|-44.3|<0.0001
71818807|NCT02023879|143140705|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.9|||<|0.0001|TWO_SIDED|95.0|-43.9|-31.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-31.8|-43.9|<0.0001
71818808|NCT02023879|143140706|SUPERIORITY_OR_OTHER||LS Mean Difference|-26.3|||<|0.0001|TWO_SIDED|95.0|-30.9|-21.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.7|-30.9|<0.0001
71818809|NCT02023879|143140707|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|279.8|||<|0.0001|TWO_SIDED|95.0|29.1|2690.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||2690.1|29.1|<0.0001
71850385|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.88|||||TWO_SIDED|90.0|1.05|3.35|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||3.35|1.05|
71818810|NCT02023879|143140708|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|354.7|||<|0.0001|TWO_SIDED|95.0|36.2|3479.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||3479.5|36.2|<0.0001
71818811|NCT02023879|143140709|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|126.0|||<|0.0001|TWO_SIDED|95.0|20.0|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|20.0|<0.0001
71850386|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.32|||||TWO_SIDED|90.0|1.32|4.07|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.07|1.32|
71850387|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.52|||||TWO_SIDED|90.0|1.48|4.29|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||4.29|1.48|
71900833|NCT02417233|143323309|OTHER||Odds Ratio (OR)|1.492||||0.125|TWO_SIDED|95.0|0.9|2.49|||Regression, Logistic|||||2.49|0.90|0.125
71900834|NCT02417233|143323310|OTHER||Odds Ratio (OR)|0.866||||0.636|TWO_SIDED|96.0|0.48|1.57|||Regression, Logistic|||||1.57|0.48|0.636
71900835|NCT02417233|143323310|OTHER||Odds Ratio (OR)|1.401||||0.165|TWO_SIDED|95.0|0.87|2.26|||Regression, Logistic|||||2.26|0.87|0.165
71900836|NCT02417233|143323311|OTHER||Odds Ratio (OR)|1.48||||0.16|TWO_SIDED|95.0|0.86|2.55|||Regression, Logistic|||||2.55|0.86|0.16
71900837|NCT02417233|143323311|OTHER||Odds Ratio (OR)|1.82||||0.03|TWO_SIDED|95.0|1.06|3.14|||Regression, Logistic|||||3.14|1.06|0.03
71900838|NCT02417233|143323312|OTHER||Odds Ratio (OR)|0.27||||0.24|TWO_SIDED|95.0|0.03|2.45|||Regression, Logistic|||||2.45|0.03|0.24
71900839|NCT02417233|143323312|OTHER||Odds Ratio (OR)|2.68||||0.2|TWO_SIDED|95.0|0.59|12.16|||Regression, Logistic|||||12.16|0.59|0.20
71900840|NCT02417233|143323313|OTHER||Odds Ratio (OR)|1.943||||0.093|TWO_SIDED|95.0|0.9|4.21|||Regression, Logistic|||||4.21|0.90|0.093
71900841|NCT02417233|143323313|OTHER||Odds Ratio (OR)|1.764||||0.152|TWO_SIDED|95.0|0.81|3.83|||Regression, Logistic|||||3.83|0.81|0.152
71900842|NCT00374907|143323384|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|18.5||||0.035|TWO_SIDED|95.0|1.3|38.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||38.7|1.3|0.0350
71850388|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.34|||||TWO_SIDED|90.0|0.772|2.32|||||Statistical comparison of Cmax on Day 8 for participants grouped using 186 as multiplier in the MDRD equation.|||2.32|0.772|
71850389|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.96|||||TWO_SIDED|90.0|1.01|3.78|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||3.78|1.01|
71850390|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.38|||||TWO_SIDED|90.0|1.21|4.67|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.67|1.21|
71850391|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|2.69|||||TWO_SIDED|90.0|1.46|4.96|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||4.96|1.46|
71850392|NCT00999336|143214403|OTHER|Geometric least squares means, ratios, and CIs were estimated from an ANCOVA of natural log transformed values.|Ratio|1.37|||||TWO_SIDED|90.0|0.793|2.38|||||Statistical comparison of Cmax on Day 8 for participants grouped using 175 as multiplier in the MDRD equation.|||2.38|0.793|
71850393|NCT02159352|143214413|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.384|||||TWO_SIDED|90.0|0.348|0.423||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.423|0.348|
71850394|NCT02159352|143214413|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.337|||||TWO_SIDED|90.0|0.306|0.371||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.||0.371|0.306|
71850395|NCT02159352|143214414|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.703|||||TWO_SIDED|90.0|0.658|0.75||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.750|0.658|
71850396|NCT02159352|143214414|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.577|||||TWO_SIDED|90.0|0.535|0.622||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).||0.622|0.535|
71850397|NCT02159352|143214417|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.768|||||TWO_SIDED|90.0|0.697|0.846||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.846|0.697|
71850398|NCT02159352|143214417|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|0.673|||||TWO_SIDED|90.0|0.611|0.742||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.||0.742|0.611|
71818812|NCT02023879|143140710|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|141.5|||<|0.0001|TWO_SIDED|95.0|22.2|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to \>9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||9999|22.2|<0.0001
71900843|NCT00374907|143323385|SUPERIORITY_OR_OTHER||Adjusted Percent Difference|27.9||||0.0204|TWO_SIDED|95.0|4.2|57.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment|||57.1|4.2|0.0204
71900844|NCT00783705|143323419|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.39|TWO_SIDED|95.0|0.7|3.0|||Generalized estimating equation model|||Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.||3.0|0.7|0.39
71900845|NCT00783705|143323423|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.10
71900846|NCT00783705|143323424|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.03
71818813|NCT02023879|143140711|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.6||||0.0002|TWO_SIDED|95.0|-29.8|-9.4||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-9.4|-29.8|0.0002
71818814|NCT02023879|143140712|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.9||||0.0892|TWO_SIDED|95.0|-17.1|1.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||1.2|-17.1|0.0892
71818815|NCT02044458|143140721|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||t-test, 2 sided|||||||.70
71818816|NCT02044458|143140722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|||||||t-test, 2 sided|||||||.38
71818817|NCT02044458|143140723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|||||||Chi-squared|||||||.57
71818818|NCT03918239|143140780|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.986|1.181|||ANOVA|||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.181|0.986|
71818819|NCT03918239|143140781|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.079|||||TWO_SIDED|90.0|0.987|1.179||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.179|0.987|
71818820|NCT03918239|143140782|OTHER|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.157|||||TWO_SIDED|90.0|1.044|1.281||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and treatment group as a fixed effect variable.||1.281|1.044|
71818821|NCT00919893|143140837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated."||||<0.05
71818822|NCT00708305|143140850|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0||||0.9762||95.0|-0.21|0.2||No adjustment was made for multiple comparisons as the primary comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.||0.20|-0.21|0.9762
71900847|NCT00783705|143323425|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.58
71900848|NCT00783705|143323426|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.06
71900849|NCT00783705|143323427|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.63
71900850|NCT00783705|143323428|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.22
71900851|NCT00783705|143323429|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Total Glutathione level between arms.||||0.06
71900852|NCT00783705|143323430|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.||||0.35
71900853|NCT00783705|143323431|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CRP level between arms.||||0.80
71900854|NCT00783705|143323432|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.||||0.22
71900855|NCT00783705|143323433|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.||||0.74
71900856|NCT00783705|143323434|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.||||0.55
71900857|NCT00783705|143323435|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Nitrotyrosine level between arms.||||0.91
71818823|NCT00708305|143140851|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.49|||<|0.0001|TWO_SIDED|95.0|0.28|0.7||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
71818824|NCT00708305|143140851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001||95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
71850399|NCT02159352|143214418|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.406|||||TWO_SIDED|90.0|1.317|1.501||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.501|1.317|
71850400|NCT02159352|143214418|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|1.154|||||TWO_SIDED|90.0|1.07|1.244||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).||1.244|1.070|
71850401|NCT01214109|143214424|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|82.62||||||90.0|74.45|91.69|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||91.69|74.45|
71850402|NCT01214109|143214424|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|96.17||||||90.0|69.33|133.42|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||133.42|69.33|
71850403|NCT01214109|143214425|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.01||||||90.0|80.76|95.92|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||95.92|80.76|
71850404|NCT01214109|143214425|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|89.37||||||90.0|81.16|98.42|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||98.42|81.16|
71850405|NCT01214109|143214426|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|88.82||||||90.0|79.89|98.76|||ANOVA|||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||98.76|79.89|
71850406|NCT01214109|143214426|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|91.97||||||90.0|60.07|140.25|||ANOVA|||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||140.25|60.07|
71850407|NCT01214109|143214427|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|92.84||||||90.0|83.8|102.86|||ANOVA|||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment||102.86|83.8|
71850408|NCT01214109|143214427|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|95.05||||||90.0|84.88|106.43|||ANOVA|||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment||106.43|84.88|
71882320|NCT01500278|143283494|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09|||=|0.532|TWO_SIDED|95.0|0.82|1.45||The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (\<2 years or \>=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.|Regression, Logistic|||||1.45|0.82|=0.532
71882321|NCT02459795|143283502|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.0|||||TWO_SIDED|90.0|-7.0|12.92|||Yates correction|||||12.92|-7.00|
71882322|NCT01297270|143283532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
71900858|NCT00783705|143323436|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.||||0.46
71900859|NCT00783705|143323437|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.||||0.52
71900860|NCT03596177|143323478|SUPERIORITY||Mean Difference (Net)|-2.58||||0.011|TWO_SIDED|90.0|-4.15|-1.0|||ANCOVA|||||-1.00|-4.15|0.011
71900861|NCT03596177|143323479|SUPERIORITY||Mean Difference (Net)|-45.481||||0.002|TWO_SIDED|90.0|-67.777|-23.186|||ANCOVA|||Statistical Analysis for Day 32||-23.186|-67.777|0.002
71900862|NCT03596177|143323479|SUPERIORITY||Mean Difference (Net)|-41.323||||0.011|TWO_SIDED|90.0|-66.74|-15.907|||ANCOVA|||Statistical Analysis for Day 59||-15.907|-66.740|0.011
71900863|NCT03596177|143323480|SUPERIORITY||Mean Difference (Net)|-1551.194|||<|0.001|TWO_SIDED|90.0|-2190.515|-911.873|||ANCOVA|||Statistical Analysis for Day 32||-911.873|-2190.515|<0.001
71900864|NCT03596177|143323480|SUPERIORITY||Mean Difference (Net)|-1332.515||||0.015|TWO_SIDED|90.0|-2187.711|-477.318|||ANCOVA|||Statistical Analysis for Day 59||-477.318|-2187.711|0.015
71900865|NCT03596177|143323481|SUPERIORITY||Mean Difference (Net)|-3.173||||0.384|TWO_SIDED|90.0|-9.368|3.022|||ANCOVA|||||3.022|-9.368|0.384
71900866|NCT03596177|143323482|SUPERIORITY||Mean Difference (Net)|-10.039||||0.351|TWO_SIDED|90.0|-28.287|8.209|||ANCOVA|||||8.209|-28.287|0.351
71900867|NCT03596177|143323483|SUPERIORITY||Mean Difference (Net)|0.186||||0.968|TWO_SIDED|90.0|-7.858|8.229|||ANCOVA|||||8.229|-7.858|0.968
71900868|NCT03596177|143323484|SUPERIORITY||Mean Difference (Net)|0.867||||0.58|TWO_SIDED|90.0|-1.81|3.545|||ANCOVA|||||3.545|-1.810|0.580
71900869|NCT03596177|143323485|SUPERIORITY||Mean Difference (Net)|-3.645||||0.324|TWO_SIDED|90.0|-9.894|2.603|||ANCOVA|||||2.603|-9.894|0.324
71900870|NCT03596177|143323486|SUPERIORITY||Mean Difference (Net)|-5.672||||0.412|TWO_SIDED|90.0|-17.415|6.072|||ANCOVA|||||6.072|-17.415|0.412
71900871|NCT03596177|143323487|SUPERIORITY||Mean Difference (Net)|7.357||||0.177|TWO_SIDED|90.0|-1.742|16.456|||ANCOVA|||||16.456|-1.742|0.177
71900872|NCT03596177|143323488|SUPERIORITY||Mean Difference (Net)|15.186||||0.168|TWO_SIDED|90.0|-3.151|33.523|||ANCOVA|||||33.523|-3.151|0.168
71900873|NCT03596177|143323489|SUPERIORITY||Mean Difference (Net)|-2.54||||0.009|TWO_SIDED|90.0|-4.05|-1.03|||ANCOVA|||||-1.03|-4.05|0.009
71900874|NCT03596177|143323490|SUPERIORITY||Mean Difference (Net)|-5.122||||0.107|TWO_SIDED|90.0|-10.364|0.119|||ANCOVA|||||0.119|-10.364|0.107
71900875|NCT03596177|143323491|SUPERIORITY||Mean Difference (Net)|-1.848||||0.085|TWO_SIDED|90.0|-3.605|-0.091|||ANCOVA|||||-0.091|-3.605|0.085
71900876|NCT03596177|143323492|SUPERIORITY||Mean Difference (Net)|-3.159||||0.204|TWO_SIDED|90.0|-7.326|1.007|||ANCOVA|||||1.007|-7.326|0.204
71900877|NCT03596177|143323493|SUPERIORITY||Mean Difference (Net)|-0.019||||0.145|TWO_SIDED|90.0|-0.041|0.003|||ANCOVA|||||0.003|-0.041|0.145
71900878|NCT03596177|143323494|SUPERIORITY||Mean Difference (Net)|-26.001||||0.001|TWO_SIDED|90.0|-37.801|-14.201|||ANCOVA|||||-14.201|-37.801|0.001
71900879|NCT03596177|143323495|SUPERIORITY||Mean Difference (Net)|-12.332||||0.01|TWO_SIDED|90.0|-19.726|-4.938|||ANCOVA|||||-4.938|-19.726|0.010
71900880|NCT00968253|143323501|SUPERIORITY_OR_OTHER||Maximum tolerated dose|5.0|||||TWO_SIDED||||||||Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD|||||
71900881|NCT01301742|143323512|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.5|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|151.77|165.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|||165.53|151.77|
71900882|NCT01301742|143323513|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|115.0|STANDARD_DEVIATION|13.8|||TWO_SIDED|90.0|106.15|124.59|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||124.59|106.15|
71900883|NCT01301742|143323514|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.29|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|151.41|165.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.|Standard deviation is actually the intra-individual gCV|||165.49|151.41|
71900884|NCT04400318|143323518|SUPERIORITY||Odds Ratio (OR)|9.81|||<|0.001|TWO_SIDED|95.0|3.13|30.82|||Cochran-Mantel-Haenszel|||Odds Ratio, 95% confidence interval (CI) of the odds ratio and p-value between the dupilumab and placebo group based on the Cochran-Mantel-Haenszel (CMH) test adjusted by ICS dose level (medium/high) and region (Eastern Europe/ROW).||30.82|3.13|<0.001
71900885|NCT04400318|143323519|SUPERIORITY||Least square mean difference|21.76|STANDARD_ERROR_OF_MEAN|14.022||0.138|TWO_SIDED|95.0|-7.73|51.25|||MMRM|||The mixed model for repeated measures (MMRM) included study intervention, baseline value, region, ICS dose level, visits, study intervention by visit interaction, and baseline by visit interaction terms all as fixed effects. Region, ICS, study intervention and visits were considered as categorical parameters.||51.25|-7.73|0.138
71900886|NCT04400318|143323520|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-4.92|STANDARD_ERROR_OF_MEAN|0.798|<|0.001|TWO_SIDED|95.0|-6.5|-3.34|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of global lung UCSF mucus scoring, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction and baseline-by-visit interaction as covariates.||-3.34|-6.50|<0.001
71900887|NCT04400318|143323521|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure is reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only 2 secondary outcome measures (#4 and #5) were included in this procedure.|Least square mean difference|-53.45|STANDARD_ERROR_OF_MEAN|39.562||0.18|TWO_SIDED|95.0|-132.09|25.19|||MMRM|||MMRM model included study intervention (dupilumab, placebo), baseline value of trimmed distal \[s\]iRaw at TLC, region (Eastern Europe/ROW), ICS dose level (medium/high), visit (up to Week 24), study intervention-by-visit interaction, and baseline-by-visit interaction as covariates.||25.19|-132.09|0.180
71900888|NCT01096446|143323531|NON_INFERIORITY_OR_EQUIVALENCE|The Chi Square satistical calculation was used for analysis.||||||0.011|TWO_SIDED|95.0|||||Chi-squared|||Four infants(44%)in the control group developed hypertriglyceridemia (\>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (\>200 mg/dl) during the first week of life.||||0.011
71900889|NCT03395197|143323589|SUPERIORITY||Hazard Ratio (HR)|0.627|||<|0.0001|TWO_SIDED|95.0|0.506|0.777||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, if hazard ratio \< 1, it indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H01: HRrPFS ≥1 vs H11: HRrPFS \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the all-comers population for Part 2 Cohort 1.||0.777|0.506|<0.0001
71900890|NCT03395197|143323590|SUPERIORITY||Hazard Ratio (HR)|0.447|||<|0.0001|TWO_SIDED|95.0|0.328|0.61||1-sided|Log Rank||Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.|The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.||0.610|0.328|<0.0001
71900891|NCT01808118|143323630|OTHER||||||<|0.001||||||2-sided Pearson's chi-square test|Chi-squared|||||||<0.001
71850409|NCT01964547|143214464|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.|Estimated mean treatment difference|-1.47|STANDARD_ERROR_OF_MEAN|2.492|||ONE_SIDED|97.5|-6.41||||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).|||-6.41|
71850410|NCT01964547|143214465|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.|Estimated mean treatment difference|-0.29|STANDARD_ERROR_OF_MEAN|1.323|||ONE_SIDED|97.5||2.33|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||2.33||
71850411|NCT01964547|143214466|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.02||||0.0001|TWO_SIDED|95.0|1.96|8.22|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||8.22|1.96|0.0001
71850412|NCT01964547|143214467|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.79||||0.0142|TWO_SIDED|95.0|1.23|6.31|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.31|1.23|0.0142
71850413|NCT01964547|143214468|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.07||||0.0019|TWO_SIDED|95.0|1.51|6.21|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.||6.21|1.51|0.0019
71850414|NCT01964547|143214469|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.36|STANDARD_ERROR_OF_MEAN|1.88||0.212|TWO_SIDED|95.0|-6.09|1.37|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.||1.37|-6.09|0.212
71850415|NCT01964547|143214472|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.88|STANDARD_ERROR_OF_MEAN|8.25||0.556|TWO_SIDED|95.0|-11.51|21.27|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.||21.27|-11.51|0.556
71850416|NCT01964547|143214472|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann median difference|-1.0||||0.088|TWO_SIDED|95.0|-3.0|0.0|||Wilcoxon (Mann-Whitney)|||The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.||0|-3|0.088
71850417|NCT03246724|143214474|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. A 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||As a sensitivity analysis, an ANCOVA model will be fit to the data adjusting for factors that are out of balance following randomization. The mean difference between the adjusted means will be calculated.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Testable hypothesis: Patient satisfaction mean will be non-inferior when given oral triazolam in comparison to IV midazolam during all basic cataracts, retina, cornea, and glaucoma ocular procedures.~Null hypothesis: The null hypothesis is that the oral sedation group will have a primary endpoint mean equal to or less than that of the IV sedation group by the non-inferiority margin or more."||||<0.05
71850418|NCT03246724|143214475|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Surgeon satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean surgeon satisfaction score for oral triazolam will be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: Mean surgeon satisfaction score for oral triazolam will not be statistically significant in comparison to mean surgeon satisfaction score for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
71882323|NCT01297270|143283532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.4||||0.0007|TWO_SIDED|95.0|7.3|27.4|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||27.4|7.3|0.0007
71882324|NCT01297270|143283533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.7|||<|0.0001|TWO_SIDED|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||30.6|10.7|<0.0001
71882325|NCT01297270|143283533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.6||||0.0014|TWO_SIDED|95.0|6.5|26.7|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction|||26.7|6.5|0.0014
71900892|NCT01808118|143323649|OTHER||||||<|0.001|||||||Log Rank|||The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.||||<0.001
71850419|NCT03246724|143214476|NON_INFERIORITY|A non-inferiority margin of 0.5, will assure that, if non-inferiority is proven, the mean patient satisfaction with oral sedation will correspond to scores corresponding to satisfied or higher. We determined a 0.5 margin to be considered clinically similar enough to declare non-inferiority because it allows for expected patient satisfaction variability, and demonstrates ample justification for providers to offer oral sedation as a safe alternative.|||||<|0.05||||||Anesthesiologist/CRNA satisfaction score will be independently analyzed. Summary statistics including, means, standard deviations along with points estimates of the mean difference between the two groups and 90% Confidence Intervals.|ANCOVA|If lower bound of the 90% two-sided Confidence Interval of mean difference is higher than -0.5, the oral sedation will be deemed non-inferior to IV.||"Null hypothesis: Mean anesthesiologist/CRNA satisfaction score for oral triazolam will be statistically significant in comparison to mean anesthesiologist/CRNA satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:Mean anesthesiologist/CRNA satisfaction score for oral triazolam will not be statistically significant in comparison to mean satisfaction score for IV midazolam during cataracts, retina, cornea, and glaucoma procedures."||||<0.05
71850420|NCT03246724|143214477|OTHER|Additional anesthesia intervention will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis:The total additional anesthesia interventions for oral triazolam will be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures.~Alternate hypothesis:The total additional anesthesia interventions for oral triazolam will not be statistically significant in comparison to additional anesthesia interventions for IV midazolam during cataracts, retina, cornea, and glaucoma procedures"||||<0.05
71850421|NCT03246724|143214478|OTHER|Surgical complications will be using summary statistics including, counts and proportions along with point's estimates of the proportion difference between the two groups and 90% Confidence Intervals.|||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: The total surgical complications for oral triazolam will be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures.~Alternate hypothesis: The total surgical complications for oral triazolam will not be statistically significant in comparison to total surgical complications for IV midazolam during all cataracts, retina, cornea, and glaucoma ocular procedures."||||<0.05
71850422|NCT00960206|143214479|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.0832
71900893|NCT03650452|143323677|SUPERIORITY||Hodges-Lehmann Estimation|-30.48||||0.0007|TWO_SIDED|95.0|-46.99|-13.19||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed Analysis of Covariance (ANCOVA) adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-13.19|-46.99|0.0007
71900894|NCT03650452|143323678|SUPERIORITY||Hodges-Lehmann Estimate|-25.93||||0.0024|TWO_SIDED|95.0|-43.96|-10.69||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency and indication.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-10.69|-43.96|0.0024
71900895|NCT03650452|143323679|SUPERIORITY||Hodges-Lehmann Estimate|-50.0||||0.0001|TWO_SIDED|95.0|-75.03|-25.09||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||-25.09|-75.03|0.0001
71900896|NCT03650452|143323680|SUPERIORITY||Hodges-Lehmann Estimate|-16.22||||0.147|TWO_SIDED|95.0|-39.5|4.49||The p-value is 2-sided and it is for the difference of percent change from baseline between TAK-935 and Placebo were computed using Rank Transformed ANCOVA adjusting for baseline seizure frequency.|Ranked ANCOVA||The location shift (TAK-935 - Placebo) and Asymptotic 95% confidence interval between TAK-935 and Placebo (TAK-935 - Placebo) were based on Hodges-Lehmann Estimation from un-adjusted rank statistics.|||4.49|-39.50|0.1470
71900897|NCT03650452|143323683|SUPERIORITY||Least Square (LS) Mean|0.1|STANDARD_DEVIATION|0.21||0.6829|TWO_SIDED|95.0|-0.32|0.49||The p-value is 2-sided and it is for the difference (TAK-935 - Placebo) of change from baseline between TAK-935 and Placebo was computed using MMRM.|Mixed-Model Repeated Measure (MMRM)||The MMRM model included treatment and visit as factors along with treatment\*visit interaction and baseline score as a covariate; and visit as repeated measure.|||0.49|-0.32|0.6829
71900898|NCT02273050|143323688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.885|STANDARD_ERROR_OF_MEAN|0.0994|<|0.001|TWO_SIDED|95.0|-1.08|-0.689|||ANCOVA|||||-0.689|-1.080|<0.001
71900899|NCT02273050|143323688|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.1005||0.034|TWO_SIDED|95.0|-0.41|-0.016|||ANCOVA|||||-0.016|-0.410|0.034
71900900|NCT02273050|143323689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.5|||<|0.001|TWO_SIDED|95.0|29.0|46.0|||Fisher Exact|||||46.0|29.0|<0.001
71900901|NCT02273050|143323689|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.7||||0.011|TWO_SIDED|95.0|2.6|18.9|||Fisher Exact|||||18.9|2.6|0.011
71900902|NCT02273050|143323690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.39|STANDARD_ERROR_OF_MEAN|0.158|<|0.001|TWO_SIDED|95.0|-1.7|-1.08|||ANCOVA|||||-1.08|-1.70|<0.001
71900903|NCT02273050|143323690|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.159||0.046|TWO_SIDED|95.0|-0.63|0.0|||ANCOVA|||||0.00|-0.63|0.046
71900904|NCT02273050|143323691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-416.0|STANDARD_ERROR_OF_MEAN|51.54|<|0.001|TWO_SIDED|95.0|-517.3|-314.6|||ANCOVA|||||-314.6|-517.3|<0.001
71900905|NCT02273050|143323691|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-169.3|STANDARD_ERROR_OF_MEAN|52.05||0.001|TWO_SIDED|95.0|-271.7|-66.9|||ANCOVA|||||-66.9|-271.7|0.001
71900906|NCT02273050|143323692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.9|||<|0.001|TWO_SIDED|95.0|26.0|43.9|||Fisher Exact|||||43.9|26.0|<0.001
71900907|NCT02273050|143323692|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.6||||0.02|TWO_SIDED|95.0|2.3|20.9|||Fisher Exact|||||20.9|2.3|0.020
71679547|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
71679548|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1493
71679549|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0026
71679550|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0652|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0652
71679551|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3601|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3601
71679552|NCT02612610|142877083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0086|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0086
71679553|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3893|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3893
71679554|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2803|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2803
71818825|NCT00708305|143140851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001||95.0|0.28|0.7||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||0.70|0.28|<0.0001
71818826|NCT00708305|143140851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.44|||<|0.0001|TWO_SIDED|95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.65|1.23|<0.0001
71818827|NCT00708305|143140851|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.95|||<|0.0001|TWO_SIDED|95.0|0.74|1.16||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||1.16|0.74|<0.0001
71850423|NCT00960206|143214479|SUPERIORITY_OR_OTHER|||||||0.1657|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems||||0.1657
71900908|NCT02273050|143323693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-3.7|-2.25|||ANCOVA|||||-2.25|-3.70|<0.001
71900909|NCT02273050|143323693|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.374||0.002|TWO_SIDED|95.0|-1.88|-0.41|||ANCOVA|||||-0.41|-1.88|0.002
71850424|NCT00960206|143214480|SUPERIORITY_OR_OTHER|||||||0.3701|||||||Fisher Exact|||To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have \< 80 for all three arms||||0.3701
71850425|NCT00960206|143214482|SUPERIORITY_OR_OTHER|||||||0.6011|||||||Fisher Exact|||Compare the # of cases at 10 years satisfied with their total hip replacement for all three groups||||0.6011
71850426|NCT00960206|143214482|SUPERIORITY_OR_OTHER|||||||0.206|||||||Fisher Exact|||Compare the # of cases at 10 years for having pain in their hip for all three groups||||0.2060
71850427|NCT02255474|143214485|SUPERIORITY||Mean Difference (Final Values)|-1.01|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons, treatment group p-value|Mixed Models Analysis|||Both eyes used in analysis adjusting for correlation.||||<0.01
71900910|NCT02273050|143323694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-13.3|-4.5|||Fisher Exact|||||-4.5|-13.3|<0.001
71900911|NCT02273050|143323694|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||>|0.999|TWO_SIDED|95.0|-2.3|2.3|||Fisher Exact|||||2.3|-2.3|>0.999
71900912|NCT02297438|143323695|SUPERIORITY||Hazard Ratio (HR)|0.677||||0.0012|TWO_SIDED|95.0|0.529|0.867||1-sided p-value from the adjusted log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral vs. non-visceral) per Randomization.||0.867|0.529|0.0012
71900913|NCT02297438|143323696|SUPERIORITY||Hazard Ratio (HR)|0.861||||0.14778|TWO_SIDED|95.0|0.651|1.139||1-sided p-value from the log-rank test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.139|0.651|0.14778
71900914|NCT02297438|143323697|SUPERIORITY||Odds Ratio (OR)|1.301||||0.154|TWO_SIDED|95.0|0.805|2.1||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.100|0.805|0.154
71900915|NCT02297438|143323698|SUPERIORITY||Odds Ratio (OR)|1.255||||0.206|TWO_SIDED|95.0|0.762|2.066||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.066|0.762|0.206
71900916|NCT02297438|143323699|SUPERIORITY||Odds Ratio (OR)|1.315||||0.135|TWO_SIDED|95.0|0.825|2.095||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.095|0.825|0.135
71900917|NCT02297438|143323700|SUPERIORITY||Odds Ratio (OR)|1.392||||0.117|TWO_SIDED|95.0|0.825|2.346||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.346|0.825|0.117
71900918|NCT02297438|143323703|SUPERIORITY||Odds Ratio (OR)|0.945||||0.471|TWO_SIDED|95.0|0.533|1.673||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.673|0.533|0.471
71900919|NCT02297438|143323704|SUPERIORITY||Odds Ratio (OR)|0.878||||0.383|TWO_SIDED|95.0|0.474|1.621||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.621|0.474|0.383
71900920|NCT02297438|143323705|SUPERIORITY||Odds Ratio (OR)|1.227||||0.248|TWO_SIDED|95.0|0.725|2.082||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.082|0.725|0.248
71900921|NCT02297438|143323706|SUPERIORITY||Odds Ratio (OR)|1.349||||0.189|TWO_SIDED|95.0|0.731|2.509||1-sided p-value was from exact test.|Fisher Exact||An Odds Ratio \>1 means better response in favor of Palbociclib + Letrozole group.|Stratified by disease site (visceral versus non-visceral) per Randomization.||2.509|0.731|0.189
71900922|NCT02297438|143323707|SUPERIORITY||Hazard Ratio (HR)|0.947||||0.36502|TWO_SIDED|95.0|0.698|1.286||1-sided p-value was from exact test.|Log Rank||Assuming Cox proportional hazards, hazard ratio less than 1 indicates reduction in hazard rate in favor of Palbociclib + Letrozole.|Stratified by disease site (visceral versus non-visceral) per Randomization.||1.286|0.698|0.36502
71900923|NCT02297438|143323714|SUPERIORITY||Mean|0.031||||0.1914|TWO_SIDED|95.0|-0.02|0.08|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.08|-0.02|0.1914
71900924|NCT02297438|143323715|SUPERIORITY||Mean|3.358||||0.0078|TWO_SIDED|95.0|0.88|5.83|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||5.83|0.88|0.0078
71900925|NCT02297438|143323716|SUPERIORITY||Mean|0.476||||0.7862|TWO_SIDED|95.0|-2.97|3.92|||Mixed effects model||A positive change indicates improvement from baseline and a negative change indicates deterioration.|The analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||3.92|-2.97|0.7862
71900926|NCT02042404|143323719|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
71900927|NCT02042404|143323720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
71900928|NCT02042404|143323721|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||repeated measures ANOVA|||||||<0.0001
71900929|NCT02042404|143323722|SUPERIORITY_OR_OTHER|||||||0.0281|TWO_SIDED||||||repeated measures ANOVA|||||||0.0281
71900930|NCT00972244|143323745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.0987|<|0.0001|TWO_SIDED|95.0|-0.67|-0.28||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.28|-0.67|<0.0001
71900931|NCT00972244|143323745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.1009|<|0.0001|TWO_SIDED|95.0|-0.65|-0.26||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.26|-0.65|<0.0001
71900932|NCT00972244|143323745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.53|-0.92|<0.0001
71900933|NCT00972244|143323745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.1018|<|0.0001|TWO_SIDED|95.0|-0.99|-0.59||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)||-0.59|-0.99|<0.0001
71900934|NCT00972244|143323746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.08|STANDARD_ERROR_OF_MEAN|4.7589|<|0.0001|TWO_SIDED|95.0|-35.45|-16.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-16.70|-35.45|<0.0001
71900935|NCT00972244|143323746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.42|STANDARD_ERROR_OF_MEAN|4.71|<|0.0001|TWO_SIDED|95.0|-38.7|-20.14||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-20.14|-38.70|<0.0001
71900936|NCT00972244|143323746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.94|STANDARD_ERROR_OF_MEAN|4.7402|<|0.0001|TWO_SIDED|95.0|-42.28|-23.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-23.60|-42.28|<0.0001
71900937|NCT00972244|143323746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.37|STANDARD_ERROR_OF_MEAN|4.8358|<|0.0001|TWO_SIDED|95.0|-50.9|-31.85||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-31.85|-50.90|<0.0001
71900938|NCT00972244|143323747|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.2||||1|TWO_SIDED|95.0|-9.1|7.6||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||7.6|-9.1|1.0000
71900939|NCT00972244|143323747|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.3||||0.2057|TWO_SIDED|95.0|-2.3|18.8||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||18.8|-2.3|0.2057
71900940|NCT00972244|143323747|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.2||||0.6203|TWO_SIDED|95.0|-6.2|13.2||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||13.2|-6.2|0.6203
71818828|NCT00708305|143140852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.83||||0.0151|TWO_SIDED|95.0|0.12|1.72||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.72|0.12|0.0151
71818829|NCT00708305|143140852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.36|||<|0.0001|TWO_SIDED|95.0|0.69|2.36||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.36|0.69|<0.0001
71818830|NCT00708305|143140852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.01|||<|0.0001|TWO_SIDED|95.0|2.06|4.05||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments. Tests were 2-sided.||4.05|2.06|<0.0001
71818831|NCT00708305|143140852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.75|||<|0.0001|TWO_SIDED|95.0|0.41|1.27||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.27|0.41|<0.0001
71818832|NCT00708305|143140852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.1|||<|0.0001|TWO_SIDED|95.0|1.5|2.74||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||2.74|1.50|<0.0001
71818833|NCT00708305|143140852|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.01|||<|0.0001|TWO_SIDED|95.0|0.73|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.73|<0.0001
71818834|NCT00708305|143140853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.5545|TWO_SIDED|95.0|-0.22|0.47||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.47|-0.22|0.5545
71818835|NCT00708305|143140853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4||||0.0003|TWO_SIDED|95.0|0.15|0.71||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.71|0.15|0.0003
71850428|NCT02255474|143214486|SUPERIORITY||quadratic coefficient|0.02||||0.05|TWO_SIDED||||||Mixed Models Analysis|||Individual subject eye length profiles were fit using quadratic equations as a function of gaze angle. The analysis of quadratic coefficients included treatment group, study year (categorical variable), and their interaction adjusted for age, study site, and ethnicity.||||0.05
71850429|NCT02255474|143214487|SUPERIORITY||regression coefficient|-0.12||||0.05|TWO_SIDED||||||Regression, Linear|Models control for age, sex, axial length at baseline, race, treatment group, treatment group by race interaction.||This analysis looks at the three-year change in spherical equivalent refractive error for different eccentricities of peripheral defocus measured with contact lenses in place||||0.05
71850430|NCT02255474|143214488|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.05|TWO_SIDED|||||Adjusted for multiple comparisons|Mixed Models Analysis|||Both eyes used in the analysis controlling for the correlation.||||0.05
71850431|NCT02158806|143214540|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Cox Proportional Hazard|0.85|STANDARD_ERROR_OF_MEAN|0.146||0.246|TWO_SIDED|95.0|0.64|1.13|||Log Rank||Placebo group = reference group|Placebo group = reference group||1.13|0.64|0.246
71850432|NCT02158806|143214541|SUPERIORITY|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Risk Ratio (RR)|0.88||||0.073|TWO_SIDED|95.0|0.76|1.01|||Chi-squared|||||1.01|0.76|0.073
71850433|NCT02158806|143214542|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.25|TWO_SIDED|95.0|-1.9|0.5||Adjusted for baseline values.|ANCOVA|One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.|Placebo group = reference group.|||0.5|-1.9|0.25
71850434|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|1.1||||0.714|TWO_SIDED|95.0|-5.0|7.2|||Regression, Linear|Adjusted for baseline values||Change in Physical Functioning||7.2|-5.0|0.714
71850435|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|1.4||||0.768|TWO_SIDED|95.0|-8.0|10.8|||Regression, Linear|Adjusted for baseline values||Change in Role Physical||10.8|-8.0|0.768
71850436|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|2.3||||0.449|TWO_SIDED|95.0|-3.7|8.4|||Regression, Linear|Adjusted for baseline values||Change in Bodily Pain||8.4|-3.7|0.449
71850437|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|-0.3||||0.873|TWO_SIDED|95.0|-4.3|3.6|||Regression, Linear|Adjusted for baseline values||Change in General Health||3.6|-4.3|0.873
71850438|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|4.2||||0.057|TWO_SIDED|95.0|-0.1|8.5|||Regression, Linear|Adjusted for baseline values||Change in Vitality||8.5|-0.1|0.057
71850439|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|1.0||||0.756|TWO_SIDED|95.0|-5.1|7.0|||Regression, Linear|Adjusted for baseline values||Change in Social Functioning||7.0|-5.1|0.756
71850440|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|3.7||||0.4|TWO_SIDED|95.0|-4.9|12.3|||Regression, Linear|Adjusted for baseline values||Change in Role Emotional||12.3|-4.9|0.400
71850441|NCT02158806|143214543|SUPERIORITY||Mean Difference (Net)|-2.3||||0.236|TWO_SIDED|95.0|-6.2|1.5|||Regression, Linear|Adjusted for baseline values||Change in Mental Health||1.5|-6.2|0.236
71850442|NCT02158806|143214544|SUPERIORITY||Mean Difference (Net)|3.4||||0.156|TWO_SIDED|95.0|-1.3|8.0||Adjusted for baseline values|Regression, Linear|||||8.0|-1.3|0.156
71850443|NCT02158806|143214545|SUPERIORITY||Mean Difference (Net)|-1.5||||0.438|TWO_SIDED|95.0|-5.2|2.2|||Regression, Linear|Adjusted for baseline values||Change in social function||2.2|-5.2|0.438
71850444|NCT02158806|143214545|SUPERIORITY||Mean Difference (Net)|-1.3||||0.408|TWO_SIDED|95.0|-4.5|1.9|||Regression, Linear|Adjusted for baseline values||Change in domestic activities||1.9|-4.5|0.408
71850445|NCT02158806|143214545|SUPERIORITY||Mean Difference (Net)|-1.3||||0.568|TWO_SIDED|95.0|-5.6|3.1|||Regression, Linear|Adjusted for baseline values||Change in cosmesis||3.1|-5.6|0.568
71850446|NCT02158806|143214545|SUPERIORITY||Mean Difference (Net)|-3.0||||0.257|TWO_SIDED|95.0|-8.1|2.2|||Regression, Linear|Adjusted for baseline values||Change in emotional status||2.2|-8.1|0.257
71850447|NCT02158806|143214545|SUPERIORITY||Mean Difference (Net)|-1.9||||0.273|TWO_SIDED|95.0|-5.2|1.5|||Regression, Linear|Adjusted for baseline values||||1.5|-5.2|0.273
71850448|NCT02158806|143214546|SUPERIORITY||Risk Ratio (RR)|1.01||||0.917|TWO_SIDED|95.0|0.87|1.17|||Chi-squared|||||1.17|0.87|0.917
71850449|NCT02158806|143214547|SUPERIORITY||Incidence Rate Ratio|1.1||||0.71|TWO_SIDED|95.0|0.7|1.7|||IRR test statistic|Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.||||1.7|0.7|0.71
71850450|NCT01898299|143214548|SUPERIORITY||Cohen's d effectsize|0.48||||0.036|TWO_SIDED||||||ANCOVA|Control for Chlopromazine equivalents||||||0.036
71850451|NCT02340806|143214549|SUPERIORITY|||||||0.67|||||||Chi-squared, Corrected|||||||.67
71850452|NCT02340806|143214550|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
71850453|NCT02340806|143214551|SUPERIORITY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||||||.21
71900941|NCT00972244|143323747|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.7||||0.205|TWO_SIDED|95.0|-2.0|19.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0||19.5|-2.0|0.2050
71900942|NCT03480282|143323751|OTHER|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||This was a descriptive feasibility study.|This was an exploratory and descriptive study to learn if it was feasible to provide PCPs with their patients (aged 76-89) with information about their 10-year prognosis and engage in shared decision making around stopping screening. We measured among the 90 patients that the 45 PCPs saw whether their intentions to be screened declined after seeing their PCP.|This was a descriptive feasibility study.|||<0.001
71900943|NCT03480282|143323751|OTHER|This was a descriptive feasibility study.|Risk Difference (RD)|0.05|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This was a descriptive feasibility study.|Because the observations were matched by the patient, we used the Wilcoxon signed-rank test, a nonparametric paired test|||<0.001
71900944|NCT05761444|143323770|OTHER||Least Squares (LS) mean difference|-21.22|||<|0.0001|TWO_SIDED|95.0|-29.26|-13.19||The analysis of covariance (ANCOVA) model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-13.19|-29.26|<0.0001
71900945|NCT05761444|143323773|OTHER||LS mean difference|-15.96|||<|0.0001|TWO_SIDED|95.0|-23.56|-8.36||The ANCOVA model with treatment group (ezetimibe/atorvastatin, atorvastatin) and history of statin administration (yes, no) as fixed effects and baseline LDL-C as a covariate.|ANCOVA|||||-8.36|-23.56|<0.0001
71900946|NCT04716933|143323777|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.48|0.97||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||0.97|0.48|
71900947|NCT04716933|143323778|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.54|1.12||||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate||1.12|0.54|
71900948|NCT04716933|143323779|OTHER||Percent Difference|11.3|||||TWO_SIDED|95.0|-2.0|24.2||||||Comparision based on unstratified Miettinen \& Nurminen method||24.2|-2.0|
71900949|NCT05692154|143323887|SUPERIORITY||Least Square Mean Difference|-4.24|STANDARD_ERROR_OF_MEAN|2.015||0.038|TWO_SIDED|95.0|-8.24|-0.23|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.23|-8.24|0.038
71900950|NCT05692154|143323888|SUPERIORITY||Least Square Mean Difference|-4.75|STANDARD_ERROR_OF_MEAN|2.088||0.025|TWO_SIDED|95.0|-8.9|-0.6|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-0.60|-8.90|0.025
71900951|NCT05692154|143323889|SUPERIORITY||Least Square Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|3.247||0.048|TWO_SIDED|95.0|-12.95|-0.05|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance model, with treatment group as fixed effect and baseline TNSS (H0 at Visit 4) as covariate.|||-0.05|-12.95|0.048
71900952|NCT05692154|143323890|SUPERIORITY||Least Square Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.89||0.011|TWO_SIDED|95.0|-13.21|-1.73|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Visit 4) as covariate.|||-1.73|-13.21|0.011
71900953|NCT05692154|143323891|SUPERIORITY||Least Square Mean Difference|-18.45|STANDARD_ERROR_OF_MEAN|10.211||0.074|TWO_SIDED|95.0|-38.74|1.83|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TNSS (Day 1) as covariate.|||1.83|-38.74|0.074
71900954|NCT05692154|143323892|SUPERIORITY||Least Square Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|11.672||0.729|TWO_SIDED|95.0|-27.24|19.12|||ANCOVA||Least-squares means, standard errors and p-value are taken from an analysis of covariance, with treatment group as fixed categorical effect and baseline TOSS (H0 at Day 1) as covariate.|||19.12|-27.24|0.729
71850454|NCT02340806|143214552|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||.14
71850455|NCT02340806|143214553|SUPERIORITY|||||||0.66|||||||Kruskal-Wallis|||||||.66
71850456|NCT02340806|143214555|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||.92
71850457|NCT02340806|143214556|SUPERIORITY|||||||0.58|||||||Kruskal-Wallis|||||||.58
71850458|NCT02340806|143214557|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||.67
71850459|NCT02340806|143214558|SUPERIORITY|||||||0.99|||||||Chi-squared|||||||.99
71850460|NCT02340806|143214559|SUPERIORITY|||||||0.37|||||||Kruskal-Wallis|||||||.37
71850461|NCT04520256|143214588|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71850462|NCT04520256|143214589|SUPERIORITY||Estimated Change|-0.27||||0.693|TWO_SIDED|95.0|-0.54|0.01|||Mixed Models Analysis|||||0.01|-.54|0.693
71850463|NCT04520256|143214589|SUPERIORITY||Estimated Change|0.09||||0.9|TWO_SIDED|95.0|0.01|0.18|||Mixed Models Analysis|||||0.18|0.01|0.900
71850464|NCT04520256|143214589|SUPERIORITY||Estimated Change|-0.03||||0.96|TWO_SIDED|95.0|-0.06|0.01|||Mixed Models Analysis|||||0.01|-0.06|0.960
71850465|NCT04520256|143214589|SUPERIORITY||Estimated Change|0.44||||0.113|TWO_SIDED|95.0|0.01|0.88|||Mixed Models Analysis|||||0.88|0.01|0.113
71850466|NCT04520256|143214589|SUPERIORITY||Estimated Change|0.92||||0.187|TWO_SIDED|95.0|0.01|1.84|||Mixed Models Analysis|||||1.84|0.01|0.187
71850467|NCT04520256|143214590|SUPERIORITY|||||||0.999|||||||Mixed Models Analysis|||||||0.999
71850468|NCT04520256|143214591|SUPERIORITY||Estimated Proportion|0.12||||0.999|TWO_SIDED|95.0|0.0|0.56|||Mixed Models Analysis|||||.56|0|.999
71850469|NCT04520256|143214591|SUPERIORITY||Estimated Proportion|0.15||||0.999|TWO_SIDED|95.0|0.0|0.68|||Mixed Models Analysis|||||.68|0|.999
71850470|NCT04520256|143214591|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.52|||Mixed Models Analysis|||||.52|0|.999
71850471|NCT04520256|143214591|SUPERIORITY||Estimated Proportion|0.11||||0.999|TWO_SIDED|95.0|0.0|0.5|||Mixed Models Analysis|||||.50|0|.999
71850472|NCT04520256|143214591|SUPERIORITY||Estimated Proportion|0.1||||0.999|TWO_SIDED|95.0|0.0|0.47|||Mixed Models Analysis|||||.47|0|.999
71850473|NCT05492786|143214592|SUPERIORITY|||||||0.517||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts with information about their risk status (patients randomized to the High-risk Alert or High-risk Alert with Risk Factors arms) compared with those whose clinicians were shown the standard alert. Alternative hypothesis: patients in the High-risk Alert and High-risk Alert with Risk Factors arms will exhibit improved flu vaccination rates compared with those in the standard Alert arm.||||0.517
71850474|NCT05492786|143214592|SUPERIORITY|||||||0.226||||||The p-value reported is 2-tailed and based on heteroskedasticity-robust standard errors.|Regression, Linear|||Null hypothesis: there is no difference in flu shots for patients whose clinicians were shown alerts the factors that contributed to a patient's high risk (High-risk Alert with Risk Factors arm) compared with those whose clinicians were shown the alert with risk level only (High-risk Alert arm). Alternative hypothesis: patients in the High-risk Alert with Risk Factors arm will exhibit improved flu vaccination rates compared with those in the High-risk Alert arm.||||0.226
71850475|NCT04620733|143214609|SUPERIORITY||Risk Difference (RD)|41.7|||<|0.0001|TWO_SIDED|95.0|27.7|53.4||Two-sided p-value for pair-wise comparison was based on the CMH test adjusted for both randomization stratification variables (baseline ALP level: \< 350 U/L and ≥ 350 U/L; baseline Pruritus NRS: \< 4 and ≥ 4).|Cochran-Mantel-Haenszel|||||53.4|27.7|< 0.0001
71850476|NCT04620733|143214612|SUPERIORITY||Risk Difference (RD)|25.0|||<|0.0001|TWO_SIDED|95.0|18.3|33.2|||Cochran-Mantel-Haenszel||Two-sided p-value for pair-wise comparison is based on the Cochran Mantel Haenszel test adjusted for both stratification variables (baseline ALP level: \< 350 U/L and \>= 350 U/L; baseline pruritus NRS: \< 4 and \>= 4).|||33.2|18.3|< 0.0001
71850477|NCT04620733|143214613|SUPERIORITY||Least Squares (LS) Mean Difference|-1.5||||0.0047|TWO_SIDED|95.0|-2.5|-0.5|||MMRM|Mixed-Effect Model Repeated Measure (MMRM)||||-0.5|-2.5|0.0047
71850478|NCT02221934|143214614|SUPERIORITY||Risk Difference (RD)|0.176||||0.002|TWO_SIDED|95.0|0.07|0.283|||Regression, Logistic||Difference in Responders between groups presented.|||0.283|0.070|0.002
71850479|NCT00264576|143214627|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.04|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.04|0.70|
71850480|NCT00264576|143214627|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.46|0.7|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.70|0.46|
71850481|NCT00264576|143214627|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.95|1.36|||ANOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.36|0.95|
71900955|NCT01519245|143323896|SUPERIORITY_OR_OTHER|||||||0.0493||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of primary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0493
71900956|NCT01519245|143323898|SUPERIORITY_OR_OTHER|||||||0.1876||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.1876
71900957|NCT01519245|143323899|SUPERIORITY_OR_OTHER|||||||0.093||95.0|||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.||||0.0930
71850482|NCT00264576|143214627|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12|||ANOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
71818836|NCT00708305|143140853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.56|0.58|<0.0001
71818837|NCT00708305|143140853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.36|||<|0.0001|TWO_SIDED|95.0|0.15|0.68||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signal Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.68|0.15|<0.0001
71818838|NCT00708305|143140853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||1.35|0.58|<0.0001
71900958|NCT01954121|143323912|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.|adjusted difference in proportions|-22.9|||||TWO_SIDED|95.0|-33.1|-12.6||||||The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and \>2 seizures) as covariates.||-12.6|-33.1|
71900959|NCT00576693|143323949|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Log Rank|||The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.||||0.0252
71900960|NCT00804193|143323950|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).|Difference in Percentage of Participants|9.0|||||TWO_SIDED|90.0|-0.69|18.85|||Wald's method, Yates|CI calculated using Wald's method with Yates' continuity correction.|The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||18.85|-0.69|
71900961|NCT00804193|143323951|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|1.0||||0.001|TWO_SIDED|90.0|-7.08|9.24|||Wald's method with Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||9.24|-7.08|0.001
71900962|NCT00804193|143323952|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|4.0||||0.001|TWO_SIDED|90.0|-4.6|14.24|||Wald's method Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.|||14.24|-4.60|0.001
71900963|NCT01617434|143323966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|||<|0.0001||95.0|-1.39|-0.99|||Mixed Models Analysis|||The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.||-0.99|-1.39|<0.0001
71818839|NCT00708305|143140853|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.56|0.26|<0.0001
71818840|NCT00708305|143140854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.02||||0.6865|TWO_SIDED|95.0|-0.13|0.08||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.08|-0.13|0.6865
71818841|NCT00708305|143140854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.1756|TWO_SIDED|95.0|-0.02|0.12||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.12|-0.02|0.1756
71900964|NCT01617434|143323967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.0001||95.0|-1.7|-0.86|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-0.86|-1.70|<0.0001
71818842|NCT00708305|143140854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.38||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.38|0.16|<0.0001
71818843|NCT00708305|143140854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.11||||0.0023|TWO_SIDED|95.0|0.04|0.22||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.22|0.04|0.0023
71818844|NCT00708305|143140854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.34|||<|0.0001|TWO_SIDED|95.0|0.22|0.51||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.51|0.22|<0.0001
71818845|NCT00708305|143140854|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.18|||<|0.0001|TWO_SIDED|95.0|0.12|0.25||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.25|0.12|<0.0001
71818846|NCT00708305|143140855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.04||||0.0783|TWO_SIDED|95.0|-0.08|0.0||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.00|-0.08|0.0783
71818847|NCT00708305|143140855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0531|TWO_SIDED|95.0|0.0|0.07||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.00|0.0531
71818848|NCT00708305|143140855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.14||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.14|0.07|<0.0001
71818849|NCT00708305|143140855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.08||||0.0005|TWO_SIDED|95.0|0.03|0.15||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.15|0.03|0.0005
71818850|NCT00708305|143140855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.20|0.08|<0.0001
71818851|NCT00708305|143140855|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.07|||<|0.0001|TWO_SIDED|95.0|0.04|0.1||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.10|0.04|<0.0001
71818852|NCT00708305|143140856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.4309|TWO_SIDED|95.0|-0.03|0.01||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.01|-0.03|0.4309
71900965|NCT01617434|143323968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001||95.0|-2.01|-1.18|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-1.18|-2.01|<0.0001
71900966|NCT01617434|143323969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|||<|0.0001||95.0|-3.85|-2.37|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.||-2.37|-3.85|<0.0001
71900967|NCT01617434|143323970|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.91|||<|0.0001||95.0|5.45|14.59|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||14.59|5.45|<0.0001
71900968|NCT01617434|143323971|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.12|||<|0.0001||95.0|9.92|40.84|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.||40.84|9.92|<0.0001
71900969|NCT03283163|143323975|OTHER|||||||0.04|||||||t-test, 2 sided|||paired samples t-test to compare PTSD severity from baseline to endpoint (week 13).||||.040
71818853|NCT00708305|143140856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.0726|TWO_SIDED|95.0|0.0|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.00|0.0726
71818854|NCT00708305|143140856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04|||<|0.0001|TWO_SIDED|95.0|0.03|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.03|<0.0001
71818855|NCT00708305|143140856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0107|TWO_SIDED|95.0|0.01|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.06|0.01|0.0107
71818856|NCT00708305|143140856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.05|||<|0.0001|TWO_SIDED|95.0|0.03|0.07|||Wilcoxon Signed Rank Test|No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.07|0.03|<0.0001
71818857|NCT00708305|143140856|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.03||||0.0012|TWO_SIDED|95.0|0.01|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.||0.04|0.01|0.0012
71818858|NCT04827134|143140868|OTHER||Ratio of Geometric Least Square Means|0.88|||||TWO_SIDED|90.0|0.8344|0.9282|||||An analysis of variance (ANOVA) was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9282|0.8344|
71818859|NCT04827134|143140868|OTHER||Ratio of Geometric Least Square Means|0.8578|||||TWO_SIDED|90.0|0.8168|0.9007|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9007|0.8168|
71818860|NCT04827134|143140868|OTHER||Ratio of Geometric Least Square Means|0.8919|||||TWO_SIDED|90.0|0.8316|0.9566|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9566|0.8316|
71818861|NCT04827134|143140869|OTHER||Ratio of Geometric Least Square Means|0.8744|||||TWO_SIDED|90.0|0.8293|0.9219|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9219|0.8293|
71818862|NCT04827134|143140869|OTHER||Ratio of Geometric Least Square Means|0.8567|||||TWO_SIDED|90.0|0.8159|0.8995|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.8995|0.8159|
71818863|NCT04827134|143140869|OTHER||Ratio of Geometric Least Square Means|0.8798|||||TWO_SIDED|90.0|0.8202|0.9438|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.9438|0.8202|
71818864|NCT04827134|143140870|OTHER||Ratio of Geometric Least Square Means|0.7102|||||TWO_SIDED|90.0|0.6598|0.7643|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7643|0.6598|
71818865|NCT04827134|143140870|OTHER||Ratio of Geometric Least Square Means|0.4503|||||TWO_SIDED|90.0|0.3976|0.51|||||An analysis of variance was performed on parameter Cmax for Analyte ABC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.5100|0.3976|
71818866|NCT04827134|143140870|OTHER||Ratio of Geometric Least Square Means|0.6373|||||TWO_SIDED|90.0|0.5594|0.726|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed with Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted.|||0.7260|0.5594|
71818867|NCT04827134|143140871|OTHER||Ratio of Geometric Least Square Means|0.9148|||||TWO_SIDED|90.0|0.8834|0.9472|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9472|0.8834|
71818868|NCT04827134|143140871|OTHER||Ratio of Geometric Least Square Means|0.8847|||||TWO_SIDED|90.0|0.8303|0.9426|||||An analysis of variance was performed on parameter AUC(0-inf) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9426|0.8303|
71818869|NCT04827134|143140872|OTHER||Ratio of Geometric Least Square Means|0.9163|||||TWO_SIDED|90.0|0.8862|0.9475|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9475|0.8862|
71900970|NCT03283163|143323976|OTHER|||||||0.69|||||||t-test, 2 sided|||paired samples t-test to compare degree of pain-related interference from baseline to endpoint (week 13).||||.69
71818870|NCT04827134|143140872|OTHER||Ratio of Geometric Least Square Means|0.8806|||||TWO_SIDED|90.0|0.8251|0.9398|||||An analysis of variance was performed on parameter AUC(0-t) for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.9398|0.8251|
71818871|NCT04827134|143140873|OTHER||Ratio of Geometric Least Square Means|0.7284|||||TWO_SIDED|90.0|0.6576|0.8068|||||An analysis of variance was performed on parameter Cmax for Analyte DTG to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.8068|0.6576|
71900971|NCT03283163|143323977|OTHER|||||||0.098|||||||t-test, 2 sided|||paired samples t-test to compare severity of pain catastrophizing from baseline to endpoint (week 13).||||.098
71900972|NCT03283163|143323978|OTHER|||||||0.194|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of resting ALLO+PA levels from baseline to endpoint (week 13).||||.194
71850483|NCT00264576|143214627|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.5|0.75|||ANOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.75|0.50|
71850484|NCT00264576|143214627|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be \>0.5.|Ratio of GMT|1.31|||||TWO_SIDED|95.0|1.09|1.57|||ANOVA|||"The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.57|1.09|
71850485|NCT00264576|143214633|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.7|1.03|||ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.03|0.70|
71850486|NCT00264576|143214633|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.52|0.76|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.76|0.52|
71850487|NCT00264576|143214633|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.16|||||TWO_SIDED|95.0|0.98|1.38|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.38|0.98|
71850488|NCT00264576|143214633|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.92|||||TWO_SIDED|95.0|0.76|1.12||To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|ANCOVA|||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.12|0.76|
71850489|NCT00264576|143214633|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.57|0.83|||ANCOVA|||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||0.83|0.57|
71850490|NCT00264576|143214633|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate non-inferiority of cTIV to eTIV\_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be \>0.5.|Ratio of GMT|1.33|||||TWO_SIDED|95.0|1.13|1.58|||ANCOVA|||"The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV\_f(i)) - log(GMTcTIV(i)) \<0.301 ↔ GMTcTIV(i) / GMTeTIV\_f(i) \>0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV\_f(i)=GMT for strain i in eTIV\_f group."||1.58|1.13|
71882958|NCT00781456|143285026|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.5|STANDARD_ERROR_OF_MEAN|0.44||0.256|TWO_SIDED|95.0|-0.36|1.37||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment||1.37|-0.36|0.256
71900973|NCT03283163|143323979|OTHER|paired samples t-test||||||0.343|||||||t-test, 2 sided|||paired samples t-tests were conducted for comparison of peak ALLO+PA levels (30 minutes post MAXEX) from baseline to endpoint (week 13).||||.343
71900974|NCT04238663|143323987|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|1.06|||||TWO_SIDED|90.0|0.976|1.16|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator.|||1.16|0.976|
71900975|NCT04238663|143323987|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.983|||||TWO_SIDED|90.0|0.897|1.08||||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.||1.08|0.897|
71900976|NCT04238663|143323987|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (Cmax) falls completely within the range 0.80-1.25.~The PK parameter Cmax was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of Geometric Least Square Mean|0.926|||||TWO_SIDED|90.0|0.851|1.01|||||For Ratio of geometric least square mean (GLSM): EU is the numerator and US Avastin acts as the denominator|||1.01|0.851|
71900977|NCT04238663|143323988|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|1.07|||||TWO_SIDED|90.0|1.0|1.14|||||For the comparison, MB02 represents the numerator and EU Avastin represents the denominator|||1.14|1.00|
71900978|NCT04238663|143323988|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.998|||||TWO_SIDED|90.0|0.944|1.05|||||For the comparison, MB02 represents the numerator and US Avastin represents the denominator.|||1.05|0.944|
71900979|NCT04238663|143323988|EQUIVALENCE|"Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 0.80-1.25.~The PK parameter AUC\[0-∞\] was log-transformed (base e) prior to analysis and was analysed using an ANCOVA model. The model included treatment as a fixed effect and body weight as a covariate."|Ratio of GLSM|0.934|||||TWO_SIDED|90.0|0.884|0.988|||||EU Avastin corresponds to the numerator and US Avastin corresponds to the denominator|||0.988|0.884|
71900980|NCT03141086|143323995|SUPERIORITY||Mean Difference (Final Values)|1.711||||0.1272|TWO_SIDED|95.0|-1.34|4.762|||ANOVA|||||4.762|-1.340|0.1272
71900981|NCT03141086|143323996|SUPERIORITY||Mean Difference (Final Values)|2.866||||0.0607|TWO_SIDED|95.0|-0.821|6.553|||Mixed Models Analysis|||3.5 hours post dose||6.553|-0.821|0.0607
71818872|NCT04827134|143140873|OTHER||Ratio of Geometric Least Square Means|0.5191|||||TWO_SIDED|90.0|0.4535|0.5943|||||An analysis of variance was performed on parameter Cmax for Analyte 3TC to compare treatment arms Cohort 2: DOVATO (DTG/3TC) Fed with Cohort 2: DOVATO (DTG/3TC) Fasted.|||0.5943|0.4535|
71900982|NCT03141086|143323996|SUPERIORITY||Mean Difference (Net)|1.975||||0.0919|TWO_SIDED|95.0|-1.024|4.973|||Mixed Models Analysis|||5.5 hours post dose||4.973|-1.024|0.0919
71818873|NCT00988351|143140940|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.4|=|0.27|TWO_SIDED|95.0|-0.35|1.26||level of significance \<0.05, Power = 0.80|t-test, 2 sided|||||1.26|-.35|= 0.27
71900983|NCT03141086|143323996|SUPERIORITY||Mean Difference (Net)|1.576||||0.0811|TWO_SIDED|95.0|-0.697|3.848|||Mixed Models Analysis|||7.5 hours post dose||3.848|-0.697|0.0811
71900984|NCT03141086|143323996|SUPERIORITY||Mean Difference (Net)|0.879||||0.2026|TWO_SIDED|95.0|-1.268|3.026|||Mixed Models Analysis|||9.5 hours post dose||3.026|-1.268|0.2026
71900985|NCT01678807|143324023|SUPERIORITY_OR_OTHER||Percent Difference|13.8|||||TWO_SIDED|95.0|-3.4|30.3|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||30.3|-3.4|
71900986|NCT01678807|143324023|SUPERIORITY_OR_OTHER||Percent Difference|10.8|||||TWO_SIDED|95.0|-6.4|27.4|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||27.4|-6.4|
71900987|NCT01678807|143324024|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
71818874|NCT00988351|143140941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.65|TWO_SIDED|95.0|-1.3|2.1|||t-test, 2 sided|||Patients using PAP (average of \>=1/2 hour per night) at 6 weeks clinic visit||2.1|-1.3|= 0.65
71850491|NCT00092456|143214678|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
71850492|NCT00092456|143214678|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
71850493|NCT00092456|143214678|NON_INFERIORITY_OR_EQUIVALENCE|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||95.0||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P\<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANCOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.||||<0.001
71850494|NCT02834624|143214688|OTHER||||||<|0.05|||||||t-test, 1 sided|||Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.||||<.05
71850495|NCT02834624|143214690|OTHER|||||||0.63|||||||t-test, 1 sided|||||||0.63
71850496|NCT03072238|143214719|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0335|TWO_SIDED|95.0|0.61|0.98|||Log Rank|||||0.98|0.61|0.0335
71850497|NCT03072238|143214720|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0431|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||||0.99|0.71|0.0431
71818875|NCT00988351|143140942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.71|=|0.33|TWO_SIDED|95.0|-0.73|2.1||\< 0.05 criteria for statistical significance|t-test, 2 sided|||Patients using PAP (average \>=1/2 hour per nightly use) at 6 weeks clinic visit||2.1|-0.73|=0.33
71818876|NCT00988351|143140943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|||=|0.49|TWO_SIDED|95.0|-1.12|2.29|||t-test, 2 sided|||Patients using PAP (average \>= 1/2 hour of nightly use) at 6 weeks clinic visit||2.29|-1.12|=0.49
71818877|NCT00988351|143140944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.51|=|0.07|TWO_SIDED|95.0|-1.92|0.09||P \< 0.05 considered statistically significant|t-test, 2 sided|||participants using PAP (average \>=1/2 hour of use) at 6 weeks clinic visit||0.09|-1.92|=0.07
71818878|NCT00183456|143140971|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.28|||<|0.01|TWO_SIDED|95.0|0.13|0.63|||Generalized Estimating Equations|||||0.63|0.13|<0.01
71818879|NCT00183456|143140972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.68||||0.05|TWO_SIDED|95.0|1.22|5.89|||Generalized Estimating Equations|||||5.89|1.22|0.05
71818880|NCT00183456|143140973|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.36||||0.05|TWO_SIDED|95.0|0.16|0.84|||Generalized Estimating Equations|||||0.84|0.16|0.05
71850498|NCT03072238|143214721|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.5698|TWO_SIDED|95.0|0.76|1.17|||Log Rank|||||1.17|0.76|0.5698
71818881|NCT00183456|143140974|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82||||0.01|TWO_SIDED|95.0|1.41|5.64|||Generalized Estimating Equations|||||5.64|1.41|0.01
71818882|NCT00183456|143140975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.01|TWO_SIDED|95.0|0.09|0.68|||Generalized Estimating Equations|||||0.68|0.09|0.01
71818883|NCT00183456|143140976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.05|TWO_SIDED|95.0|0.25|0.87|||Generalized Estimating Equations|||||0.87|0.25|0.05
71818884|NCT00183456|143140977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41||||0.01|TWO_SIDED|95.0|0.21|0.77|||Generalized Estimating Equations|||||0.77|0.21|0.01
71900988|NCT01678807|143324024|SUPERIORITY_OR_OTHER||Percent Difference|6.2|||||TWO_SIDED|95.0|0.4|14.8|||||Estimate based on Miettinen \& Nurminen method stratified by asthma status.|||14.8|0.4|
71900989|NCT06018350|143324054|OTHER|||||||0.002|||||||McNemar|||||||0.002
71818885|NCT00183456|143140978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.05|TWO_SIDED|95.0|0.14|0.79|||Generalized Estimating Equations|||||0.79|0.14|0.05
71818886|NCT00183456|143140979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.01|TWO_SIDED|95.0|0.14|0.64|||Generalized Estimating Equations|||||0.64|0.14|0.01
71818887|NCT00183456|143140980|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.41||||0.01|TWO_SIDED|95.0|1.25|4.65|||Generalized Estimating Equations|||||4.65|1.25|0.01
71850499|NCT03072238|143214722|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.2515|TWO_SIDED|95.0|0.79|1.07|||Log Rank|||||1.07|0.79|0.2515
71850500|NCT03072238|143214723|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.601|TWO_SIDED|95.0|0.58|1.01|||Log Rank|||||1.01|0.58|0.6010
71850501|NCT03072238|143214724|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.1723|TWO_SIDED|95.0|0.72|1.06|||Log Rank|||||1.06|0.72|0.1723
71900990|NCT03625986|143324056|OTHER||Mean Difference (Final Values)|-186.68||||0.0039|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0039
71900991|NCT03625986|143324057|OTHER||Mean Difference (Final Values)|-0.06||||0.8103|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8103
71900992|NCT03625986|143324058|OTHER||Mean Difference (Final Values)|-3.14||||0.0105|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0105
71850502|NCT03072238|143214725|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.1566|TWO_SIDED|95.0|0.65|1.07|||Log Rank|||||1.07|0.65|0.1566
71850503|NCT03072238|143214726|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0419|TWO_SIDED|95.0|0.69|0.99|||Log Rank|||||0.99|0.69|0.0419
71850504|NCT03072238|143214727|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3198|TWO_SIDED|95.0|0.89|1.45|||Log Rank|||||1.45|0.89|0.3198
71850505|NCT03072238|143214728|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.0071|TWO_SIDED|95.0|1.06|1.47|||Log Rank|||||1.47|1.06|0.0071
71850506|NCT03072238|143214729|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0045|TWO_SIDED|95.0|0.59|0.91|||Log Rank|||||0.91|0.59|0.0045
71850507|NCT03072238|143214730|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.83|||Log Rank|||||0.83|0.61|< 0.0001
71850508|NCT03072238|143214731|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.1359|TWO_SIDED|95.0|0.57|1.08|||Log Rank|||||1.08|0.57|0.1359
71850509|NCT03072238|143214732|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1398|TWO_SIDED|95.0|0.68|1.06|||Log Rank|||||1.06|0.68|0.1398
71850510|NCT03072238|143214733|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.8239|TWO_SIDED|95.0|0.61|1.48|||Log Rank|||||1.48|0.61|0.8239
71850511|NCT03072238|143214734|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6018|TWO_SIDED|95.0|0.66|1.27|||Log Rank|||||1.27|0.66|0.6018
71850512|NCT03072238|143214735|SUPERIORITY||Difference in Overall Response Rate|20.93||||0.003|TWO_SIDED|95.0|6.2|35.65|||Cochran-Mantel-Haenszel|||||35.65|6.20|0.0030
71850513|NCT03072238|143214736|SUPERIORITY||Difference in Overall Response Rate|16.46||||0.0008|TWO_SIDED|95.0|6.66|26.27|||Cochran-Mantel-Haenszel|||||26.27|6.66|0.0008
71850514|NCT03072238|143214739|SUPERIORITY||Difference in Overall Response Rate|11.81||||0.0012|TWO_SIDED|95.0|4.34|19.29|||Cochran-Mantel-Haenszel|||||19.29|4.34|0.0012
71850515|NCT03072238|143214740|SUPERIORITY||Difference in Overall Response Rate|5.87||||0.0178|TWO_SIDED|95.0|0.83|10.9|||Cochran-Mantel-Haenszel|||||10.90|0.83|0.0178
71850516|NCT03072238|143214741|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0246|TWO_SIDED|95.0|0.45|0.95|||Log Rank|||||0.95|0.45|0.0246
71850517|NCT02489799|143214754|EQUIVALENCE|The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05).|Incidence Rate Ratio|1.06||||0.545|TWO_SIDED|95.0|0.87|1.3|||Poisson model using GEE|We fit a Poisson model using generalized estimating equations. No adjustments were made for degrees of freedom.|The incidence rate ratio compares intervention to control.|We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).||1.30|0.87|0.545
71850518|NCT01241448|143214764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29||||0.094|TWO_SIDED|90.0|-0.58|-0.01||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.01|-0.58|0.094
71850519|NCT01241448|143214764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.62|||<|0.001|TWO_SIDED|90.0|-0.9|-0.34||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.34|-0.90|<0.001
71850520|NCT01241448|143214764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.77|||<|0.01|TWO_SIDED|90.0|-1.05|-0.48||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).||-0.48|-1.05|<0.01
71850521|NCT01301183|143214795|OTHER|ANCOVA||||||0.109||||||Adjusted for baseline age, height, bone density and 12-month weight change|ANCOVA|||||||.109
71850522|NCT01301183|143214796|OTHER|||||||0.344||||||Adjusted for age, height, baseline trabecular number and change in weight over 12 months|ANCOVA|||||||0.344
71850523|NCT01072149|143214797|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.233|||<|0.001|TWO_SIDED|95.0|0.179|0.287|||Mixed Models Analysis|||||0.287|0.179|<0.001
71850524|NCT01072149|143214797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|||<|0.001|TWO_SIDED|95.0|0.165|0.275|||Mixed Models Analysis|||||0.275|0.165|<0.001
71850525|NCT01072149|143214797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|||<|0.001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|||||0.291|0.181|<0.001
71850526|NCT00080119|143214801|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.93|TWO_SIDED|95.0|0.67|1.44||Threshold p-value for significance = 0.0492|Log Rank||Hazard ratio for INH relative to Placebo|||1.44|0.67|0.93
71850527|NCT00080119|143214802|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.55|1.3||Threshold p-value for significance = 0.0493|Log Rank||Hazard ratio for INH relative to Placebo|||1.30|0.55|0.43
71850528|NCT01297595|143214851|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.58|||||TWO_SIDED|90.0|91.08|108.87||||||Natural log transformed AUC (0 - ∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||108.87|91.08|
71850529|NCT01297595|143214853|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.35|||||TWO_SIDED|90.0|90.51|109.07||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||109.07|90.51|
71900993|NCT03625986|143324059|OTHER||Mean Difference (Final Values)|2415.93||||0.0182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0182
71900994|NCT03625986|143324060|OTHER||Mean Difference (Final Values)|1.18||||0.8429|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8429
71850530|NCT01297595|143214854|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|96.84|||||TWO_SIDED|90.0|88.22|106.32||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.||106.32|88.22|
71850531|NCT03015220|143214920|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.5||||0.2963|TWO_SIDED|95.0|0.7|3.2||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.20|0.70|0.2963
71900995|NCT03625986|143324061|OTHER||Mean Difference (Final Values)|0.49||||0.4881|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.4881
71900996|NCT03625986|143324062|OTHER||Mean Difference (Final Values)|1.76||||0.0835|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0835
71900997|NCT03625986|143324063|OTHER||Mean Difference (Final Values)|-0.96||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
71900998|NCT03625986|143324064|OTHER||Odds Ratio (OR)|4.35||||0.0052|TWO_SIDED||||||Fisher Exact|||||||0.0052
71900999|NCT03625986|143324065|OTHER||Mean Difference (Final Values)|-1.95||||0.0797|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0797
71901000|NCT03625986|143324066|OTHER||Mean Difference (Final Values)|-1.44||||0.1084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1084
71901001|NCT03625986|143324067|OTHER||Mean Difference (Final Values)|3.81||||0.3469|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3469
71901002|NCT03625986|143324068|OTHER||Odds Ratio (OR)|3.3632||||0.0272|TWO_SIDED||||||Fisher Exact|||||||0.0272
71901003|NCT03625986|143324069|OTHER||Mean Difference (Final Values)|0.6||||0.589|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.589
71901004|NCT03625986|143324070|OTHER||Mean Difference (Final Values)|-0.3||||0.5448|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.5448
71901005|NCT03625986|143324071|OTHER||Mean Difference (Final Values)|15.3||||0.65|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.65
71901006|NCT03625986|143324072|OTHER||Mean Difference (Final Values)|-4.0||||0.1567|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.1567
71901007|NCT01109004|143324098|SUPERIORITY|||||||0.87||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.87
71901008|NCT01109004|143324098|SUPERIORITY|||||||0.37||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.37
71901009|NCT01109004|143324098|SUPERIORITY|||||||0.27||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.27
71901010|NCT01109004|143324099|SUPERIORITY|||||||0.92||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.92
71901011|NCT01109004|143324099|SUPERIORITY|||||||0.21||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.21
71901012|NCT01109004|143324099|SUPERIORITY|||||||0.22||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.22
71901013|NCT01109004|143324100|SUPERIORITY|||||||0.26||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.26
71901014|NCT01109004|143324100|SUPERIORITY|||||||0.53||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.53
71901015|NCT01109004|143324100|SUPERIORITY|||||||0.57||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.57
71901016|NCT01109004|143324101|SUPERIORITY|||||||0.63||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.||||0.63
71901017|NCT01109004|143324101|SUPERIORITY|||||||0.15||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.||||0.15
71901018|NCT01109004|143324101|SUPERIORITY|||||||0.33||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.||||0.33
71901019|NCT02410902|143324129|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-2.56||||0.038|TWO_SIDED|95.0|-4.98|-0.14|||ANCOVA|||||-0.14|-4.98|0.038
71901020|NCT02410902|143324130|OTHER|ANCOVA using MMRM analysis|Mean Difference (Final Values)|-1.07||||0.325|TWO_SIDED|95.0|-3.21|1.07|||ANCOVA|||||1.07|-3.21|0.325
71850532|NCT03015220|143214920|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.8||||0.5997|TWO_SIDED|95.0|0.35|1.83||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.83|0.35|0.5997
71850533|NCT03015220|143214920|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.55||||0.1871|TWO_SIDED|95.0|0.23|1.33||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.33|0.23|0.1871
71850534|NCT03015220|143214921|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.9||||0.1672|TWO_SIDED|95.0|0.76|4.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||4.72|0.76|0.1672
71850535|NCT03015220|143214921|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.6||||0.3391|TWO_SIDED|95.0|0.21|1.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.72|0.21|0.3391
71901021|NCT03059810|143324139|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|2.63|||TWO_SIDED|95.0|-4.6|5.9|||Linear mixed model (LMM)|A 95% Confidence Interval for the least squares mean difference between the follow up and baseline was used to test for non-inferiority.|Mean difference was calculated as Test (at 12-16 days follow up) - Habitual (at baseline)|It was a single arm study and the subjects' overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).||5.9|-4.6|
71901022|NCT00701727|143324140|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|||||||0.019
71901023|NCT00701727|143324141|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71901024|NCT00701727|143324142|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71901025|NCT00701727|143324143|SUPERIORITY_OR_OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.12
71901026|NCT00701727|143324144|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71901027|NCT00701727|143324145|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71901028|NCT00701727|143324146|SUPERIORITY_OR_OTHER|||||||0.95|||||||t-test, 2 sided|||||||0.95
71901029|NCT05113953|143324157|SUPERIORITY||Treatment Difference|-0.42||||0.1893|TWO_SIDED|95.0|-1.06|0.21||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.21|-1.06|0.1893
71901030|NCT05113953|143324157|SUPERIORITY||Treatment Difference|-0.06||||0.8502|TWO_SIDED|95.0|-0.69|0.57||P-value was analysed by MMRM method with change from baseline in binge eating days per week at scheduled visit as dependent variable and included fixed effect terms for treatment, trial center, visit week, interaction term of treatment by visit week.|MMRM|||||0.57|-0.69|0.8502
71901031|NCT05113953|143324158|SUPERIORITY||Treatment Difference|-0.54||||0.0313|TWO_SIDED|95.0|-1.02|-0.05||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||-0.05|-1.02|0.0313
71850536|NCT03015220|143214921|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.12||||0.011|TWO_SIDED|95.0|0.02|0.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.62|0.02|0.0110
71850537|NCT02291549|143214937|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.0074|TWO_SIDED|95.0|-0.39|-0.06||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.|ANCOVA|Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.39|0.0074
71850538|NCT02291549|143214938|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.0073|TWO_SIDED|95.0|-0.6|-0.09||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.|ANCOVA|ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.||The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.09|-0.60|0.0073
71850539|NCT02291549|143214939|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0004|TWO_SIDED|95.0|1.63|4.44||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted p-value is presented.||Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test||4.44|1.63|0.0004
71850540|NCT02291549|143214940|SUPERIORITY||Mean Difference (Final Values)|-7.96||||0.0007|TWO_SIDED|95.0|-12.1|-3.83||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.||-3.83|-12.10|0.0007
71850541|NCT02291549|143214941|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.0248|TWO_SIDED|95.0|-0.48|-0.07||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.07|-0.48|0.0248
71850542|NCT02291549|143214942|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.047|TWO_SIDED|95.0|-0.85|-0.06||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|The adjusted p-value is presentenced.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||-0.06|-0.85|0.0470
71850543|NCT02291549|143214943|SUPERIORITY|||||||0.913||||||P-value adjusted for multiplicity using the Holm's step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.||||0.9130
71850544|NCT01970527|143214955|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
71850545|NCT01970527|143214957|SUPERIORITY|||||||0.71|||||||Log Rank|||||||0.71
71850546|NCT01115309|143214959|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
71850547|NCT01115309|143214960|SUPERIORITY||||||<|0.0001||||||Paired t-tests were used to evaluate whether the change in outcomes from baseline to follow-up were statistically different from zero. A p value \<0.05 is considered statistically significant.|t-test, 2 sided|||||||<0.0001
71850548|NCT04447287|143214979|OTHER||Geometric LS Mean Ratio|89.72|||||TWO_SIDED|90.0|81.21|99.11||||||||99.11|81.21|
71850549|NCT04447287|143214980|OTHER||Geometric LS Mean Ratio|92.15|||||TWO_SIDED|90.0|80.22|105.86||||||||105.86|80.22|
71850550|NCT04447287|143214981|OTHER||Geometric LS Mean Ratio|109.09|||||TWO_SIDED|90.0|101.1|117.71||||||||117.71|101.10|
71850551|NCT04447287|143214982|OTHER||Geometric LS Mean Ratio|117.77|||||TWO_SIDED|90.0|106.41|130.34||||||||130.34|106.41|
71850552|NCT04447287|143214983|OTHER||Geometric LS Mean Ratio|79.39|||||TWO_SIDED|90.0|68.1|92.55||||||||92.55|68.10|
71850553|NCT04447287|143214984|OTHER||Geometric LS Mean Ratio|74.45|||||TWO_SIDED|90.0|59.28|93.5||||||||93.50|59.28|
71850554|NCT01307800|143215044|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.1|STANDARD_ERROR_OF_MEAN|2.4||0.994|TWO_SIDED|95.0|-0.5|8.8||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||8.8|-0.5|0.994
71850555|NCT01307800|143215044|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|2.5||0.973|TWO_SIDED|95.0|-1.9|7.9||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 1-sided alpha level of 0.025, with adjustment for multiplicity by applying the Step-down Dunnett procedure.|Mixed Models Analysis|||||7.9|-1.9|0.973
71850556|NCT01307800|143215044|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|2.2||0.896|TWO_SIDED|95.0|-1.6|7.2||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.2|-1.6|0.896
71850557|NCT01307800|143215045|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.5||0.955|TWO_SIDED|95.0|-0.7|9.3||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||9.3|-0.7|0.955
71850558|NCT01307800|143215045|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.4|STANDARD_ERROR_OF_MEAN|2.5||0.912|TWO_SIDED|95.0|-1.6|8.4||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||8.4|-1.6|0.912
71850559|NCT01307800|143215045|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.4||0.223|TWO_SIDED|95.0|-1.8|7.7||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||7.7|-1.8|0.223
71850560|NCT01307800|143215046|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.5||0.61|TWO_SIDED|95.0|-3.5|2.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.6|-3.5|0.610
71850561|NCT01307800|143215046|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.223|TWO_SIDED|95.0|-2.0|4.6||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.6|-2.0|0.223
71850562|NCT01307800|143215046|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|1.5||0.414|TWO_SIDED|95.0|-4.2|1.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.7|-4.2|0.414
71850563|NCT01307800|143215047|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|1.6||0.603|TWO_SIDED|95.0|-3.7|2.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-3.7|0.603
71850564|NCT01307800|143215047|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.7||0.192|TWO_SIDED|95.0|-1.9|4.8||The p-value was 1-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.8|-1.9|0.192
71850565|NCT01307800|143215047|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.619|TWO_SIDED|95.0|-3.9|2.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.3|-3.9|0.619
71850566|NCT01307800|143215048|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.5|STANDARD_ERROR_OF_MEAN|4.1||0.022|TWO_SIDED|95.0|1.4|17.6||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.6|1.4|0.022
71850567|NCT01307800|143215048|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|STANDARD_ERROR_OF_MEAN|4.6||0.061|TWO_SIDED|95.0|-0.4|17.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||17.8|-0.4|0.061
71850568|NCT01307800|143215048|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.2|STANDARD_ERROR_OF_MEAN|4.1||0.304|TWO_SIDED|95.0|-3.9|12.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||12.3|-3.9|0.304
71850569|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|0.8||0.036|TWO_SIDED|95.0|0.1|3.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.1|0.1|0.036
71850570|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.8||0.616|TWO_SIDED|95.0|-1.2|2.0||The comparison between 40 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-1.2|0.616
71850571|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.307|TWO_SIDED|95.0|-0.7|2.2||The comparison between 10 mg LY2140023, BID and placebo for change from baseline in PANSS positive subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.2|-0.7|0.307
71901032|NCT05113953|143324158|SUPERIORITY||Treatment Difference|0.19||||0.4471|TWO_SIDED|95.0|-0.3|0.67||P-value was analysed by MMRM method with change from baseline value as dependent variable and included treatment, trial center, visit week, treatment-by-week interaction as fixed effects and baseline-by-week interaction as covariates.|MMRM|||Change from baseline at Week 8||0.67|-0.30|0.4471
71850572|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.7||0.382|TWO_SIDED|95.0|-0.8|2.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.1|-0.8|0.382
71850573|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.107|TWO_SIDED|95.0|-0.3|2.8||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.8|-0.3|0.107
71850574|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.436|TWO_SIDED|95.0|-0.9|2.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS negative subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.0|-0.9|0.436
71850575|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3|STANDARD_ERROR_OF_MEAN|1.3||0.073|TWO_SIDED|95.0|-0.2|4.9||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.9|-0.2|0.073
71901033|NCT05137041|143324224|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71901034|NCT05137041|143324226|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.015|TWO_SIDED|95.0|-0.817|-0.137|||ANCOVA|The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).||||-0.137|-0.817|0.015
71850576|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.5|STANDARD_ERROR_OF_MEAN|1.4||0.28|TWO_SIDED|95.0|-1.2|4.2||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.2|-1.2|0.280
71850577|NCT01307800|143215049|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6|STANDARD_ERROR_OF_MEAN|1.3||0.209|TWO_SIDED|95.0|-0.9|4.0||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in PANSS general psychopathology subscores was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||4.0|-0.9|0.209
71850578|NCT01307800|143215050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.137||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.137
71850579|NCT01307800|143215050|SUPERIORITY_OR_OTHER_LEGACY|||||||0.824||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||0.824
71850580|NCT01307800|143215050|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||The p-value was 2-sided without adjustment for multiplicity.|Fisher Exact|||||||>0.999
71850581|NCT01307800|143215052|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.34|TWO_SIDED|95.0|-0.13|0.38||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.13|0.340
71850582|NCT01307800|143215052|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.14||0.659|TWO_SIDED|95.0|-0.33|0.21||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.21|-0.33|0.659
71850583|NCT01307800|143215052|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.413|TWO_SIDED|95.0|-0.14|0.35||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||0.35|-0.14|0.413
71850584|NCT01307800|143215053|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.5||0.91|TWO_SIDED|95.0|-3.1|2.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||2.7|-3.1|0.910
71850585|NCT01307800|143215053|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.8|STANDARD_ERROR_OF_MEAN|1.6||0.265|TWO_SIDED|95.0|-4.9|1.3||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.3|-4.9|0.265
71850586|NCT01307800|143215053|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.4||0.531|TWO_SIDED|95.0|-3.7|1.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||1.9|-3.7|0.531
71850587|NCT01307800|143215054|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|2.62||0.983|TWO_SIDED|95.0|-5.21|5.1||The comparison between 80 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||5.10|-5.21|0.983
71850588|NCT01307800|143215054|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|2.74||0.351|TWO_SIDED|95.0|-7.94|2.83||The comparison between 40 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||2.83|-7.94|0.351
71850589|NCT01307800|143215054|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.12|STANDARD_ERROR_OF_MEAN|2.54||0.403|TWO_SIDED|95.0|-2.86|7.11||The comparison between 10 mg LY2140023, BID and placebo for the change from baseline in EQ-5D Questionnaire (VAS) was 2-sided without adjustment for multiplicity.|ANCOVA|||||7.11|-2.86|0.403
71850590|NCT01307800|143215057|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-5.6|STANDARD_ERROR_OF_MEAN|2.4||0.021|TWO_SIDED|95.0|-10.4|-0.8||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||-0.8|-10.4|0.021
71850591|NCT01307800|143215057|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.8|STANDARD_ERROR_OF_MEAN|2.6||0.487|TWO_SIDED|95.0|-3.3|6.9||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||6.9|-3.3|0.487
71850592|NCT01307800|143215057|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.9|STANDARD_ERROR_OF_MEAN|2.4||0.693|TWO_SIDED|95.0|-5.6|3.7||The p-value was 2-sided without adjustment for multiplicity.|Mixed Models Analysis|||||3.7|-5.6|0.693
71850593|NCT01307800|143215058|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.661|TWO_SIDED|95.0|-0.1|0.06||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.10|0.661
71850594|NCT01307800|143215058|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.04||0.201|TWO_SIDED|95.0|-0.14|0.03||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.03|-0.14|0.201
71850595|NCT01307800|143215058|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.04||0.697|TWO_SIDED|95.0|-0.09|0.06||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.06|-0.09|0.697
71850596|NCT01307800|143215059|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.13||0.694|TWO_SIDED|95.0|-0.2|0.31||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.31|-0.20|0.694
71850597|NCT01307800|143215059|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.596|TWO_SIDED|95.0|-0.34|0.2||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.20|-0.34|0.596
71850598|NCT01307800|143215059|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.13||0.055|TWO_SIDED|95.0|0.0|0.49||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.49|0.00|0.055
71850599|NCT01307800|143215060|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.929|TWO_SIDED|95.0|-0.27|0.29||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.29|-0.27|0.929
71850600|NCT01307800|143215060|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.19|0.38||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.38|-0.19|0.519
71901035|NCT05137041|143324227|SUPERIORITY||Least Square Mean Difference|-15.9|STANDARD_ERROR_OF_MEAN|8.47||0.103|TWO_SIDED|95.0|-32.661|0.828||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.828|-32.661|0.103
71901036|NCT05137041|143324228|SUPERIORITY||Least Square Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|0.511|1.581||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||1.581|0.511|<0.001
71901037|NCT05137041|143324229|SUPERIORITY||Least Square Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.82||0.121|TWO_SIDED|95.0|-2.976|0.25||The p-value was adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|ANCOVA|||||0.250|-2.976|0.121
71850601|NCT01307800|143215060|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.14||0.323|TWO_SIDED|95.0|-0.13|0.4||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.40|-0.13|0.323
71850602|NCT01307800|143215061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0||||The comparison between 80 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.758
71850603|NCT01307800|143215061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.576||95.0||||The comparison between 40 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.576
71850604|NCT01307800|143215061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.425||95.0||||The comparison between 10 mg LY2140023, BID and placebo in the percentage of participants with a change from baseline in C-SSRS suicidal ideation was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Fisher Exact|||||||0.425
71901038|NCT05137041|143324230|SUPERIORITY|||||||0.564||||||The p-value is adjusted using a False Discovery Rate approach (Benjamini-Hochberg).|Log Rank|||||||0.564
71901039|NCT05137041|143324231|SUPERIORITY|||||||0.289|||||||Log Rank|||||||0.289
71901040|NCT05137041|143324232|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 1 Evening||||0.001
71850605|NCT01307800|143215064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.444||95.0||||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) model on rank-transformed change.||||||0.444
71850606|NCT01307800|143215064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||95.0||||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.799
71850607|NCT01307800|143215064|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||95.0||||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|ANOVA|ANOVA model on rank-transformed change.||||||0.073
71901041|NCT05137041|143324232|SUPERIORITY|||||||0.035|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Morning||||0.035
71901042|NCT05137041|143324232|SUPERIORITY|||||||0.004|||||||Satterthwaite t-test|||Change from Baseline at Day 2 Evening||||0.004
71901043|NCT05137041|143324232|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Morning||||0.007
71901044|NCT05137041|143324232|SUPERIORITY|||||||0.005|||||||Satterthwaite t-test|||Change from Baseline at Day 3 Evening||||0.005
71901045|NCT05137041|143324232|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Morning||||0.001
71901046|NCT05137041|143324232|SUPERIORITY|||||||0.007|||||||Satterthwaite t-test|||Change from Baseline at Day 4 Evening||||0.007
71901047|NCT05137041|143324232|SUPERIORITY|||||||0.096|||||||Satterthwaite t-test|||Change from Baseline at Day 5 Morning||||0.096
71901048|NCT05137041|143324232|SUPERIORITY|||||||0.015|||||||Satterthwaite t-test|||Change from Baseline at Day 5||||0.015
71901049|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 1 Evening||||<0.001
71901050|NCT05137041|143324233|SUPERIORITY|||||||0.001|||||||Satterthwaite t-test|||VRS: Day 2 Morning||||0.001
71901051|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 2 Evening||||<0.001
71901052|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Morning||||<0.001
71901053|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 3 Evening||||<0.001
71901054|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Morning||||<0.001
71901055|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 4 Evening||||<0.001
71901056|NCT05137041|143324233|SUPERIORITY|||||||0.024|||||||Satterthwaite t-test|||VRS: Day 5 Morning||||0.024
71901057|NCT05137041|143324233|SUPERIORITY||||||<|0.001|||||||Satterthwaite t-test|||VRS: Day 5||||<0.001
71901058|NCT05137041|143324234|SUPERIORITY||Least Square Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.415|0.903|||ANCOVA|||||0.903|0.415|<0.001
71901059|NCT02626819|143324235|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
71818888|NCT02731313|143140981|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis (H0): kappa coefficient = 0.90||||||0.7436|||||||Kappa-test p-value, 2 sided|||Rationale for the determination of the number of samples:The following hypotheses were considered: two-sided risk alpha = 5%, power (1 - beta) = 90%, a success rate (rate of positive HER-2 status) = 17%, null hypothesis (H0): kappa coefficient = 0.90. 359 samples would allow determining a first estimate of the 0.90 coefficient of correlation kappa. The total number of samples, which had to be included in this study was 395, considering a 10% rate of non-evaluable samples.||||0.7436
71818889|NCT04675242|143141001|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.4434|TWO_SIDED|95.0|-11.5|15.3|||Fisher Exact|||Difference in the proportion of study eyes with complete cure||15.3|-11.5|0.4434
71818890|NCT04675242|143141002|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.2105|TWO_SIDED|95.0|-9.5|2.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the change from baseline between treatment groups||2.1|-9.5|0.2105
71818891|NCT04675242|143141003|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.5936|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|adjusted for baseline eye dryness VAS score||Difference in the mean change from baseline||0.1|-0.2|0.5936
71818892|NCT03912220|143141005|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71818893|NCT03912220|143141006|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71818894|NCT05033080|143141007|NON_INFERIORITY|The non-inferiority margin represents a clinically acceptable loss of effectiveness that margin preserve at least 50% of the treatment effect of the active control (ELX/TEZ/IVA) compared to placebo, where the treatment effect is estimated by the lower bound of the 95% confidence interval (CI).|LS Mean difference|0.2|||<|0.0001|TWO_SIDED|95.0|-0.7|1.1|||Mixed Models Repeated Measures|||||1.1|-0.7|< 0.0001
71818895|NCT05033080|143141008|SUPERIORITY||LS Mean difference|-8.4|||<|0.0001|TWO_SIDED|95.0|-10.5|-6.3|||Mixed Models Repeated Measures|||||-6.3|-10.5|< 0.0001
71818896|NCT05033080|143141009|OTHER||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.55|3.15|||Generalized Estimated Equation Model|||||3.15|1.55|< 0.0001
71818897|NCT05033080|143141010|OTHER||Odds Ratio (OR)|2.87|||<|0.0001|TWO_SIDED|95.0|2.0|4.12|||Generalized Estimated Equation Model|||||4.12|2.00|< 0.0001
71818898|NCT03216902|143141012|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
71818899|NCT03216902|143141012|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
71850608|NCT01307800|143215065|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.46||0.761|TWO_SIDED|95.0|-0.76|1.04||The comparison between 80 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.04|-0.76|0.761
71850609|NCT01307800|143215065|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.47||0.761|TWO_SIDED|95.0|-0.78|1.06||The comparison between 40 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||1.06|-0.78|0.761
71850610|NCT01307800|143215065|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.44||0.489|TWO_SIDED|95.0|-1.17|0.56||The comparison between 10 mg LY2140023, BID and placebo was conducted at a 2-sided alpha level of 0.05 without adjustment for multiplicity.|Mixed Models Analysis|||||0.56|-1.17|0.489
71818900|NCT03216902|143141012|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
71818901|NCT03216902|143141012|SUPERIORITY|Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)|||||<|0.0001||||||P value is adjusted for multiple comparisons using Hochberg step-up procedure.|t-test, 2 sided|||This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.||||<0.0001
71818902|NCT01263106|143141021|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|1.12|||||TWO_SIDED|90.0|1.05|1.2|||Mixed Models Analysis|||||1.20|1.05|
71818903|NCT01263106|143141022|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|||||1.01|0.92|
71818904|NCT01263106|143141023|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8008|TWO_SIDED|90.0|-3.0|1.0|||Wilcoxon (Mann-Whitney)|||||1.00|-3.00|0.8008
71818905|NCT03662360|143141031|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations in scores (T3 - T1) regarding the two interest groups of patients (control and treated).||||<0.001
71818906|NCT03662360|143141032|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations scores in T3 and T1, concerning the distress of the professional caregivers in the two intereste groups of patients||||<0.01
71818907|NCT01850082|143141033|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.47|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.47
71818908|NCT01850082|143141034|SUPERIORITY|||||||0.821|||||||Chi-squared|||||||0.821
71818909|NCT01850082|143141035|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71818910|NCT01850082|143141036|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.517|TWO_SIDED|95.0|0.724|1.176|||Regression, Cox|||||1.176|0.724|0.517
71850611|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.77|||||TWO_SIDED|95.0|0.62|0.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||0.97|0.62|
71850612|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.17|||||TWO_SIDED|95.0|0.87|1.57|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.57|0.87|
71850613|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.73|1.07|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.07|0.73|
71850614|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.7|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.70|
71850615|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97|||||TWO_SIDED|95.0|0.79|1.18|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.18|0.79|
71850616|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.71|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.71|
71850617|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.8|1.36|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.36|0.80|
71850618|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|329.44|||||TWO_SIDED|95.0|242.98|446.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||446.67|242.98|
71850619|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|40.79|||||TWO_SIDED|95.0|30.27|54.97|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||54.97|30.27|
71850620|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|13.12|||||TWO_SIDED|95.0|9.92|17.34|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||17.34|9.92|
71850621|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|9.01|||||TWO_SIDED|95.0|6.46|12.56|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||12.56|6.46|
71850622|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|165.9|||||TWO_SIDED|95.0|122.95|223.85|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||223.85|122.95|
71850623|NCT00689351|143215069|SUPERIORITY_OR_OTHER||Ratio of geometric means|2.24|||||TWO_SIDED|95.0|1.83|2.75|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||2.75|1.83|
71850624|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.78|||||TWO_SIDED|95.0|0.6|1.02|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.60|
71901060|NCT02626819|143324236|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.||||||<0.05
71901061|NCT02626819|143324237|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data||||||<0.05
71901062|NCT02626819|143324238|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71901063|NCT02626819|143324239|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71850625|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.11|||||TWO_SIDED|95.0|0.83|1.48|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)||1.48|0.83|
71901064|NCT02626819|143324240|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71901065|NCT02626819|143324241|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71901066|NCT02626819|143324242|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71901067|NCT00502307|143324248|OTHER||Exact binomial distribution|24.6|||||TWO_SIDED|95.0|19.6|30.2||||||||30.2|19.6|
71901068|NCT00502307|143324248|OTHER||Exact binomial distribution|18.0|||||TWO_SIDED|95.0|13.6|23.1||||||||23.1|13.6|
71901069|NCT00502307|143324249|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71901070|NCT00502307|143324249|OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71850626|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.95|||||TWO_SIDED|95.0|0.76|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.76|
71850627|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.74|||||TWO_SIDED|95.0|0.57|0.95|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)||0.95|0.57|
71850628|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.92|||||TWO_SIDED|95.0|0.72|1.19|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)||1.19|0.72|
71850629|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.45|||||TWO_SIDED|95.0|1.11|1.88|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)||1.88|1.11|
71850630|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.78|1.4|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)||1.40|0.78|
71850631|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|234.33|||||TWO_SIDED|95.0|176.33|311.41|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)||311.41|176.33|
71850632|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|16.63|||||TWO_SIDED|95.0|12.19|22.69|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)||22.69|12.19|
71850633|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|6.84|||||TWO_SIDED|95.0|5.39|8.67|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)||8.67|5.39|
71850634|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.08|||||TWO_SIDED|95.0|3.07|5.43|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)||5.43|3.07|
71850635|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|110.92|||||TWO_SIDED|95.0|77.09|159.59|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)||159.59|77.09|
71850636|NCT00689351|143215070|SUPERIORITY_OR_OTHER||Ratio of geometric means|4.25|||||TWO_SIDED|95.0|3.39|5.33|||Student t distribution|Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.|CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)||5.33|3.39|
71850637|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.862|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.862
71850638|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.157|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.157
71850639|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.55|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.550
71850640|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.052|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.052
71850641|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.366|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.366
71850642|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.301|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.301
71850643|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.362
71850644|NCT00689351|143215071|SUPERIORITY_OR_OTHER|||||||0.718|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.718
71850645|NCT00689351|143215072|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||>0.99
71850646|NCT00689351|143215072|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.245
71850647|NCT00689351|143215072|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.447
71850648|NCT00689351|143215072|SUPERIORITY_OR_OTHER|||||||0.684|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.684
71850649|NCT00689351|143215072|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||>0.99
71850650|NCT00689351|143215072|SUPERIORITY_OR_OTHER|||||||0.578|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.578
71850651|NCT00689351|143215072|SUPERIORITY_OR_OTHER|||||||0.451|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.451
71850652|NCT00689351|143215072|SUPERIORITY_OR_OTHER|||||||0.712|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.712
71850653|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.681|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.681
71850654|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.482|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.482
71850655|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.683|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.683
71850656|NCT00689351|143215073|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||>0.99
71850657|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.533|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.533
71850658|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.692|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.692
71901071|NCT00502307|143324250|OTHER|||||||0.005|||||||Log Rank|||||||0.005
71901072|NCT00502307|143324250|OTHER|||||||0.129|||||||Log Rank|||||||0.129
71901073|NCT00502307|143324251|OTHER|||||||0.003|||||||Log Rank|||||||0.003
71901074|NCT00502307|143324251|OTHER|||||||0.089|||||||Log Rank|||||||0.089
71901075|NCT00051558|143324272|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
71901076|NCT00051558|143324273|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
71901077|NCT00051558|143324274|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||P-value for Month 3|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.058
71901078|NCT00051558|143324274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71850659|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.662|||||||Fisher Exact|||Comparison between treatments for mild redness.||||0.662
71850660|NCT00689351|143215073|SUPERIORITY_OR_OTHER|||||||0.331|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.331
71850661|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.409|||||||Fisher Exact|||Comparison between treatments for any tenderness.||||0.409
71850662|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.617|||||||Fisher Exact|||Comparison between treatments for significant tenderness.||||0.617
71850663|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.807|||||||Fisher Exact|||Comparison between treatments for any swelling.||||0.807
71850664|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||Comparison between treatments for mild swelling.||||0.527
71850665|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.144|||||||Fisher Exact|||Comparison between treatments for moderate swelling.||||0.144
71850666|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.495|||||||Fisher Exact|||Comparison between treatments for severe swelling.||||0.495
71850667|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.506|||||||Fisher Exact|||Comparison between treatments for any redness.||||0.506
71850668|NCT00689351|143215074|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild redness.||||>0.99
71850669|NCT00689351|143215074|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||Comparison between treatments for moderate redness.||||0.200
71850670|NCT00689351|143215075|SUPERIORITY_OR_OTHER|||||||0.633|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.||||0.633
71850671|NCT00689351|143215075|SUPERIORITY_OR_OTHER|||||||0.721|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.721
71850672|NCT00689351|143215075|SUPERIORITY_OR_OTHER|||||||0.009|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.009
71850673|NCT00689351|143215075|SUPERIORITY_OR_OTHER|||||||0.253|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.253
71850674|NCT00689351|143215075|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.143
71850675|NCT00689351|143215076|SUPERIORITY_OR_OTHER|||||||0.781|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.781
71818911|NCT02611830|143141070|SUPERIORITY||Risk Difference (RD)|32.3|||<|0.001|TWO_SIDED|95.0|19.7|45.0||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||45.0|19.7|<0.001
71818912|NCT02611830|143141071|SUPERIORITY||Risk Difference (RD)|35.7|||<|0.001|TWO_SIDED|95.0|22.1|49.3||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||49.3|22.1|<0.001
71818913|NCT02611830|143141072|SUPERIORITY||Risk Difference (RD)|36.1|||<|0.001|TWO_SIDED|95.0|21.2|50.9||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel|||||50.9|21.2|<0.001
71818914|NCT02611830|143141073|SUPERIORITY||Risk Difference (RD)|9.7||||0.076|TWO_SIDED|95.0|-6.6|25.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||25.7|-6.6|0.076
71818915|NCT02611830|143141074|SUPERIORITY||Risk Difference (RD)|20.6||||0.067|TWO_SIDED|95.0|-4.5|43.7||P-value was calculated by Fisher's Exact Test.|Fisher Exact|||||43.7|-4.5|0.067
71818916|NCT02058290|143141106|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||||||<0.0001
71818917|NCT02058290|143141107|SUPERIORITY_OR_OTHER|||||||0.2612|||||||ANOVA|||||||0.2612
71818918|NCT02058290|143141108|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Log Rank|||||||0.0019
71818919|NCT00405704|143141133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71818920|NCT00405704|143141134|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.55
71818921|NCT00405704|143141135|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.37
71818922|NCT00405704|143141136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.94
71818923|NCT00405704|143141137|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Log Rank|||||||0.04
71818924|NCT00405704|143141138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.065|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.065
71818925|NCT00405704|143141139|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71818926|NCT00405704|143141140|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71818927|NCT03012061|143141141|SUPERIORITY||Mean Difference (Net)|0.1758|STANDARD_ERROR_OF_MEAN|0.0426|<|0.001|TWO_SIDED|95.0|0.092|0.2595|||Mixed-model repeated measures (MMRM)||UMEC 31.25 mcg versus placebo|||0.2595|0.0920|<0.001
71818928|NCT03012061|143141141|SUPERIORITY||Mean Difference (Net)|0.1841|STANDARD_ERROR_OF_MEAN|0.0424|<|0.001|TWO_SIDED|95.0|0.1008|0.2675|||MMRM||UMEC 62.5 mcg versus placebo|||0.2675|0.1008|<0.001
71818929|NCT03012061|143141142|SUPERIORITY||Mean Difference (Net)|0.1895|STANDARD_ERROR_OF_MEAN|0.0455|<|0.001|TWO_SIDED|95.0|0.1|0.2789||Analysis of covariance (ANCOVA)|ANCOVA||UMEC 31.25 mcg vs Placebo|||0.2789|0.1000|<0.001
71818930|NCT03012061|143141142|SUPERIORITY||Mean Difference (Net)|0.1976|STANDARD_ERROR_OF_MEAN|0.0453|<|0.001|TWO_SIDED|95.0|0.1086|0.2866|||ANCOVA||UMEC 62.5 mcg vs Placebo|||0.2866|0.1086|<0.001
71818931|NCT03012061|143141145|SUPERIORITY||Median Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.0||0.083|TWO_SIDED|95.0|-0.2|3.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 4|||3.7|-0.2|0.083
71818932|NCT03012061|143141145|SUPERIORITY||Median Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.11||0.636|TWO_SIDED|95.0|-2.7|1.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 12|||1.7|-2.7|0.636
71818933|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|1.1||0.115|TWO_SIDED|95.0|-0.4|3.9|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 24|||3.9|-0.4|0.115
71818934|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.99||0.336|TWO_SIDED|95.0|-1.0|2.9|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 4|||2.9|-1.0|0.336
71818935|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.11||0.787|TWO_SIDED|95.0|-1.9|2.5|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 12|||2.5|-1.9|0.787
71818936|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|1.1||0.625|TWO_SIDED|95.0|-1.6|2.7|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 24|||2.7|-1.6|0.625
71818937|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.79||0.309|TWO_SIDED|95.0|-0.7|2.3|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 4|||2.3|-0.7|0.309
71818938|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.521|TWO_SIDED|95.0|-2.1|1.1|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 12|||1.1|-2.1|0.521
71818939|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.81||0.047|TWO_SIDED|95.0|0.0|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 24|||3.2|0.0|0.047
71818940|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.78||0.779|TWO_SIDED|95.0|-1.3|1.8|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 4|||1.8|-1.3|0.779
71850676|NCT00689351|143215076|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.060
71850677|NCT00689351|143215076|SUPERIORITY_OR_OTHER|||||||0.159|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.159
71850678|NCT00689351|143215076|SUPERIORITY_OR_OTHER|||||||0.839|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.839
71850679|NCT00689351|143215076|SUPERIORITY_OR_OTHER|||||||0.264|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.264
71850680|NCT00689351|143215077|SUPERIORITY_OR_OTHER|||||||0.563|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.563
71850681|NCT00689351|143215077|SUPERIORITY_OR_OTHER|||||||0.468|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||0.468
71850682|NCT00689351|143215077|SUPERIORITY_OR_OTHER|||||||0.535|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.535
71818941|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.82||0.204|TWO_SIDED|95.0|-0.6|2.6|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 12|||2.6|-0.6|0.204
71818942|NCT03012061|143141145|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.81||0.066|TWO_SIDED|95.0|-0.1|3.1|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 24|||3.1|-0.1|0.066
71818943|NCT03012061|143141146|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.97||0.195|TWO_SIDED|95.0|-0.7|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, Week 4|||3.2|-0.7|0.195
71818944|NCT03012061|143141146|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.84||0.457|TWO_SIDED|95.0|-1.0|2.3|||MMRM||UMEC 31.25 mcg versus Placebo, Week 12|||2.3|-1.0|0.457
71818945|NCT03012061|143141146|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.07||0.3|TWO_SIDED|95.0|-1.0|3.2|||MMRM||UMEC 31.25 mcg versus Placebo, Week 24|||3.2|-1.0|0.300
71818946|NCT03012061|143141146|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.14|TWO_SIDED|95.0|-0.5|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 4|||3.3|-0.5|0.140
71818947|NCT03012061|143141146|SUPERIORITY||Mean Difference (Net)|1.7|STANDARD_ERROR_OF_MEAN|0.84||0.045|TWO_SIDED|95.0|0.0|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 12|||3.3|0.0|0.045
71818948|NCT03012061|143141146|SUPERIORITY||Mean Difference (Net)|3.4|STANDARD_ERROR_OF_MEAN|1.07||0.002|TWO_SIDED|95.0|1.3|5.5|||MMRM||UMEC 62.5 mcg versus Placebo, Week 24|||5.5|1.3|0.002
71818949|NCT02696902|143141147|SUPERIORITY||Relative risk reduction|-23.7||||0.491|TWO_SIDED|80.0|-83.8|16.8|||Poisson regression with robust variance|||||16.8|-83.8|0.491
71818950|NCT05822921|143141165|OTHER|Independent t-test was used.||||||0.871|||||||t-test, 2 sided|||||||.871
71818951|NCT05822921|143141166|OTHER|Independent t-test was used.||||||0.896|||||||t-test, 2 sided|||||||0.896
71818952|NCT05822921|143141167|OTHER|Independent t-test was used.||||||0.351|||||||t-test, 2 sided|||||||0.351
71818953|NCT00544544|143141169|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<.001
71818954|NCT00544544|143141170|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71818955|NCT00544544|143141171|SUPERIORITY_OR_OTHER|||||||0.38|||||||Mixed Models Analysis|||||||0.38
71818956|NCT00544544|143141172|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71818957|NCT01857622|143141261|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.8|||||TWO_SIDED|95.0|-14.7|26.8|||Wilcoxon (Mann-Whitney)|no statistical test||||26.8|-14.7|
71818958|NCT01857622|143141261|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.7|||||TWO_SIDED|95.0|-15.4|25.2|||Wilcoxon (Mann-Whitney)|||||25.2|-15.4|
71818959|NCT00802737|143141306|SUPERIORITY_OR_OTHER||proportion of responders|0.24|||||TWO_SIDED|95.0|0.07|0.5|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.50|0.07|
71818960|NCT00802737|143141306|SUPERIORITY_OR_OTHER||proportion of responders|0.18|||||TWO_SIDED|95.0|0.02|0.52|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||0.52|0.02|
71818961|NCT00802737|143141306|SUPERIORITY_OR_OTHER||proportion of responders|1.0|||||TWO_SIDED|95.0|0.03|1.0|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.|||1.00|0.03|
71818962|NCT03677128|143141319|OTHER||Mean Difference (Final Values)|23.8|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71818963|NCT03677128|143141319|OTHER||Mean Difference (Final Values)|21.1|||<|0.001|TWO_SIDED||||||Kruskal-Wallis|||||||<0.001
71818964|NCT00445601|143141343|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.9|||Log Rank|||||0.90|0.48|0.01
71818965|NCT00445601|143141344|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.23|TWO_SIDED|95.0|0.18|1.49|||Log Rank|||||1.49|0.18|0.23
71850683|NCT00689351|143215077|SUPERIORITY_OR_OTHER|||||||0.019|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.019
71850684|NCT00689351|143215077|SUPERIORITY_OR_OTHER|||||||0.398|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.398
71850685|NCT00689351|143215077|SUPERIORITY_OR_OTHER|||||||0.125|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.125
71850686|NCT00689351|143215078|SUPERIORITY_OR_OTHER|||||||0.596|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.||||0.596
71850687|NCT00689351|143215078|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever \>39 degrees C but ≤40 degrees C.||||>0.99
71850688|NCT00689351|143215078|SUPERIORITY_OR_OTHER|||||||0.663|||||||Fisher Exact|||Comparison between treatments for decreased appetite.||||0.663
71850689|NCT00689351|143215078|SUPERIORITY_OR_OTHER|||||||0.439|||||||Fisher Exact|||Comparison between treatments for irritability.||||0.439
71850690|NCT00689351|143215078|SUPERIORITY_OR_OTHER|||||||0.613|||||||Fisher Exact|||Comparison between treatments for increased sleep.||||0.613
71850691|NCT00689351|143215078|SUPERIORITY_OR_OTHER|||||||0.138|||||||Fisher Exact|||Comparison between treatments for decreased sleep.||||0.138
71850692|NCT01082159|143215091|SUPERIORITY_OR_OTHER||change from baseline|3.59|STANDARD_DEVIATION|2.87|<|0.0001|TWO_SIDED|95.0|2.76|4.42|||t-test, 2 sided|||||4.42|2.76|<0.0001
71818966|NCT00214903|143141347|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE, region, and HRT user status.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||1.3|0.5|
71818967|NCT00214903|143141348|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.5|||||TWO_SIDED|95.0|0.3|0.8|||||Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.||0.8|0.3|
71818968|NCT01625910|143141351|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|-0.1|0.21||||||Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.||0.21|-0.10|
71818969|NCT01625910|143141352|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.74|0.4||||||unadjusted net difference between groups||0.40|-0.74|
71818970|NCT02959138|143141404|OTHER|The test-to-reference ratio (geometric least squares mean (GLSM) ratio) and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.68|||||TWO_SIDED|90.0|86.94|143.47||||||The Estimate statement was used to produce the point estimate and the corresponding 90% confidence interval of the difference in PK parameters of interest on a logarithmic scale.||143.47|86.94|
71818971|NCT02959138|143141404|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.04|||||TWO_SIDED|90.0|78.47|146.02||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||146.02|78.47|
71818972|NCT02959138|143141405|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.92|||||TWO_SIDED|90.0|86.92|144.12||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||144.12|86.92|
71818973|NCT02959138|143141405|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.69|||||TWO_SIDED|90.0|79.63|145.65||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||145.65|79.63|
71818974|NCT02959138|143141406|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|102.0|||||TWO_SIDED|90.0|81.42|127.79||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||127.79|81.42|
71818975|NCT02959138|143141406|OTHER|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|87.8|||||TWO_SIDED|90.0|68.14|113.13||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.||113.13|68.14|
71818976|NCT01946243|143141416|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0029
71818977|NCT01946243|143141417|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|4.2|||||ONE_SIDED|97.5|2.7||||||Units: Percent Accuracy||||2.7|
71818978|NCT01946243|143141418|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.06|||||TWO_SIDED|95.0|0.018|0.112||||||Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.||0.112|0.018|
71850693|NCT01082159|143215092|SUPERIORITY_OR_OTHER||Change from Baseline|12.17|STANDARD_DEVIATION|19.14|<|0.0001|TWO_SIDED|95.0|6.64|17.71|||t-test, 2 sided|||||17.71|6.64|<0.0001
71850694|NCT00882050|143215107|OTHER|||||||0.05|||||||Regression, Logistic|||logistic regression|Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.|||0.05
71882959|NCT00781456|143285026|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.14|STANDARD_ERROR_OF_MEAN|0.52||0.788|TWO_SIDED|95.0|-1.16|0.88||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.||0.88|-1.16|0.788
71818979|NCT01946243|143141419|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|2.3|||||ONE_SIDED|97.5|0.8||||||Units: Percent Accuracy||||0.8|
71818980|NCT01946243|143141420|SUPERIORITY_OR_OTHER||lower bound of two-sided 95% CI|0.07||||0.028|TWO_SIDED|95.0|0.007|0.125|||Monte Carlo test|||Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.||0.125|0.007|0.0280
71818981|NCT01946243|143141421|SUPERIORITY_OR_OTHER|||||||0.0025|TWO_SIDED||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.||||0.0025
71818982|NCT01189890|143141432|NON_INFERIORITY_OR_EQUIVALENCE|The predefined non-inferiority margin was 0.4%.|Difference in LS Means|0.19|||||TWO_SIDED|95.0|0.03|0.34|||ANCOVA|Controlled for treatment, estimated glomerular filtration rate (eGFR) stratum, age stratum, and baseline HbA1C.||||0.34|0.03|
71818983|NCT01189890|143141433|SUPERIORITY_OR_OTHER||Difference in Percent Incidence|-3.9||||0.009|TWO_SIDED|95.0|-7.5|-1.2|||Miettinen & Nurminen|Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.||||-1.2|-7.5|0.009
71818984|NCT01189890|143141436|SUPERIORITY_OR_OTHER||Difference in LS Means|6.7|||||TWO_SIDED|95.0|0.7|12.7|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline FPG.||||12.7|0.7|
71818985|NCT01189890|143141437|SUPERIORITY_OR_OTHER||Relative Risk|0.7|||||TWO_SIDED|95.0|0.6|0.9|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.9|0.6|
71818986|NCT01189890|143141438|SUPERIORITY_OR_OTHER||Relative Risk|0.4|||||TWO_SIDED|95.0|0.3|0.7|||Miettinen & Nurminen|Stratified by eGFR stratum and age stratum.||||0.7|0.3|
71818987|NCT01189890|143141439|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.7||||0.011|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline body weight.||||-0.2|-1.3|0.011
71818988|NCT01807221|143141442|OTHER||Mean Difference (Final Values)|-6.3||||0.8771|TWO_SIDED|90.0|-14.9|2.3|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||2.3|-14.9|0.8771
71818989|NCT01807221|143141442|OTHER||Mean Difference (Final Values)|-4.7||||0.7945|TWO_SIDED|90.0|-13.4|4.0|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||4|-13.4|0.7945
71818990|NCT01807221|143141442|OTHER||Mean Difference (Final Values)|0.1||||0.5|TWO_SIDED|90.0|-8.5|8.8|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||8.8|-8.5|0.5
71818991|NCT01807221|143141442|OTHER||Mean Difference (Final Values)|1.6||||0.4225|TWO_SIDED|90.0|-7.1|10.2|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||10.2|-7.1|0.4225
71818992|NCT01807221|143141442|OTHER||Mean Difference (Final Values)|-3.0||||0.6865|TWO_SIDED|90.0|-11.7|5.7|||Chi-squared|||Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.||5.7|-11.7|0.6865
71818993|NCT02609659|143141454|NON_INFERIORITY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 92% to achieve noninferiority.|percentage of participants|89.5|||||TWO_SIDED|95.0|83.7|95.4||||||||95.4|83.7|
71818994|NCT00900627|143141486|SUPERIORITY_OR_OTHER||Maximum Tolerated Dose|40.0|||||||||||||Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.|A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where \>25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.||||
71882960|NCT00781456|143285027|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.19||||0.182|TWO_SIDED|95.0|-0.47|0.09|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the 91-day treatment period.||0.09|-0.47|0.182
71882961|NCT00781456|143285027|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.04||||0.853|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the first month of treatment||0.19|-0.71|0.853
71882962|NCT00781456|143285027|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.26||||0.249|TWO_SIDED|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the second month of treatment||0.19|-0.71|0.249
71818995|NCT00900627|143141487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.679|TWO_SIDED|95.0|0.76|1.52||Statistical significance threshold at this analysis was 5%|Cox Proportional Hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||1.52|0.76|0.679
71901079|NCT00051558|143324274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71818996|NCT00900627|143141488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.026|TWO_SIDED|95.0|1.09|3.75||Statistical significance threshold at this analysis was 5%|Logistic Regression|Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||3.75|1.09|0.026
71818997|NCT00900627|143141489|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.607|TWO_SIDED|95.0|0.67|2.01||Statistical significance threshold at this analysis was 5%|Cox proportional hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio \<1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.||2.01|0.67|0.607
71818998|NCT01649596|143141503|SUPERIORITY_OR_OTHER||percent|10.0||||0.12|TWO_SIDED||||||Chi-squared|||||||0.12
71818999|NCT01649596|143141504|SUPERIORITY_OR_OTHER||percent|48.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|A t-test for percents was used to compare the number of participants (%) from each group reporting satisfaction (somewhat and highly satisfied).||||||<0.05
71819000|NCT00883103|143141505|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71819001|NCT00962585|143141506|SUPERIORITY_OR_OTHER|||||||0.573||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model (Analysis of covariance): Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.~The ANCOVA procedure was used to test the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp where μ1 and μp denote the mean frequency of MSVS (at Week 4 in case of primary efficacy endpoint), adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively."||||0.5730
71819002|NCT00962585|143141506|SUPERIORITY_OR_OTHER||LS means difference|1.13|||>|0.05|TWO_SIDED|95.0|-10.06|12.32|||Pair-wise comparisons|||||12.32|-10.06|>0.05
71819003|NCT00962585|143141506|SUPERIORITY_OR_OTHER||LS means difference|6.98|||>|0.05|TWO_SIDED|95.0|-3.87|17.84|||Pair-wise comparisons|||||17.84|-3.87|>0.05
71819004|NCT00962585|143141506|SUPERIORITY_OR_OTHER||LS means difference|0.94|||>|0.05|TWO_SIDED|95.0|-10.16|12.04|||Pair-wise comparisons|||||12.04|-10.16|>0.05
71819005|NCT00962585|143141507|SUPERIORITY_OR_OTHER|||||||0.7364||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|ANCOVA|"Model: Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7~1-week period = remaining days of the period since the last visit (i.e. period following first 7 days, as per CRF)"||||0.7364
71819006|NCT00962585|143141507|SUPERIORITY_OR_OTHER||LS means difference|-0.19|||>|0.05|TWO_SIDED|95.0|-12.38|12.01|||Pair-wise comparisons|||||12.01|-12.38|>0.05
71819007|NCT00962585|143141507|SUPERIORITY_OR_OTHER||LS means difference|4.77|||>|0.05|TWO_SIDED|95.0|-6.94|16.48|||Pair-wise comparisons|||||16.48|-6.94|>0.05
71819008|NCT00962585|143141507|SUPERIORITY_OR_OTHER||LS means difference|-1.63|||>|0.05|TWO_SIDED|95.0|-13.41|10.15|||Pair-wise comparisons|||||10.15|-13.41|>0.05
71819009|NCT00962585|143141508|SUPERIORITY_OR_OTHER|||||||0.1217||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1 and 2.|Repeated measures ANCOVA|"Mixed Model: MSVS = Baseline (MSVS) + Treatment + Site + Weeks + Treatment x Weeks~Difference Between Means: S-equol treatment group - Placebo"||\# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.||||0.1217
71901080|NCT00051558|143324274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901081|NCT00051558|143324274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901082|NCT00051558|143324274|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901083|NCT00051558|143324275|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||P-value for 3 Months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.120
71901084|NCT00051558|143324275|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71819010|NCT00962585|143141508|SUPERIORITY_OR_OTHER||LS means difference|-3.77|||>|0.05||95.0|-12.69|5.16|||Pair-wise comparisons|||Week 1, Treatment Effect||5.16|-12.69|>0.05
71819011|NCT00962585|143141508|SUPERIORITY_OR_OTHER||LS means difference|9.69|||<|0.05|TWO_SIDED|95.0|0.79|18.6|||Pair-wise comparisons|||Week 1, Treatment Effect||18.60|0.79|<0.05
71819012|NCT00962585|143141508|SUPERIORITY_OR_OTHER||LS means difference|1.31|||>|0.05|TWO_SIDED|95.0|-7.73|10.36|||Pair-wise comparisons|||Week 1, Treatment Effect||10.36|-7.73|>0.05
71819013|NCT00962585|143141508|SUPERIORITY_OR_OTHER||LS means difference|-6.7|||>|0.05|TWO_SIDED|95.0|-18.36|4.96|||Pair-wise comparisons|||Week 2, Treatment Effect||4.96|-18.36|>0.05
71819014|NCT00962585|143141508|SUPERIORITY_OR_OTHER||LS means difference|3.56|||>|0.05|TWO_SIDED|95.0|-8.01|15.14|||Pair-wise comparisons|||Week 2, Treatment Effect||15.14|-8.01|>0.05
71819015|NCT00962585|143141508|SUPERIORITY_OR_OTHER||LS means difference|0.91|||>|0.05|TWO_SIDED|95.0|-10.77|12.58|||Pair-wise comparisons|||Week 2, Treatment Effect||12.58|-10.77|>0.05
71901085|NCT00051558|143324275|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901086|NCT00051558|143324275|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901087|NCT00051558|143324276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.||||<0.001
71901088|NCT00051558|143324276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901089|NCT00051558|143324276|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901090|NCT00051558|143324277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36-month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||<0.001
71819016|NCT00962585|143141509|SUPERIORITY_OR_OTHER|||||||0.1609||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 1, 2 and 4.|Repeated measures ANCOVA|Mixed Model: Severity of VMS = Baseline (severity of VMS) + Treatment + Site + Weeks + Treatment x Weeks||Severity of VMS per week at each protocol visits = (Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7, where severity of vasomotor symptoms are scored as: 1 = mild, 2 = moderate and 3 = severe.||||0.1609
71819017|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|-6.34|||>|0.05|TWO_SIDED|95.0|-26.41|13.73|||Pair-wise comparisons|||Week 1, Treatment Effect||13.73|-26.41|>0.05
71819018|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|25.67|||<|0.05|TWO_SIDED|95.0|5.64|45.69|||Pair-wise comparisons|||Week 1, Treatment Effect||45.69|5.64|<0.05
71819019|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|2.09|||>|0.05|TWO_SIDED|95.0|-18.21|22.39|||Pair-wise comparisons|||Week 1, Treatment Effect||22.39|-18.21|>0.05
71819020|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|-16.14|||>|0.05|TWO_SIDED|95.0|-43.29|11.01|||Pair-wise comparisons|||Week 2, Treatment Effect||11.01|-43.29|>0.05
71819021|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|8.73|||>|0.05|TWO_SIDED|95.0|-18.19|35.65|||Pair-wise comparisons|||Week 2, Treatment Effect||35.65|-18.19|>0.05
71819022|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|-0.65|||>|0.05|TWO_SIDED|95.0|-27.8|26.5|||Pair-wise comparisons|||Week 2, Treatment Effect||26.50|-27.80|>0.05
71882963|NCT00781456|143285027|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.4||||0.119|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the third month of treatment||0.10|-0.90|0.119
71819023|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|-1.69|||>|0.05|TWO_SIDED|95.0|-28.68|25.3|||Pair-wise comparisons|||Week 4, Treatment Effect||25.30|-28.68|>0.05
71819024|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|16.15|||>|0.05|TWO_SIDED|95.0|-10.4|42.71|||Pair-wise comparisons|||Week 4, Treatment Effect||42.71|-10.40|>0.05
71819025|NCT00962585|143141509|SUPERIORITY_OR_OTHER||LS means difference|-1.29|||>|0.05|TWO_SIDED|95.0|-28.18|25.6|||Pair-wise comparisons|||Week 4, Treatment Effect||25.60|-28.18|>0.05
71819026|NCT00962585|143141510|SUPERIORITY_OR_OTHER|||||||0.2211||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal pH) = Baseline (Vaginal pH) + Treatment + Site + Weeks + Treatment x Weeks||||||0.2211
71819027|NCT00962585|143141510|SUPERIORITY_OR_OTHER||LS means difference|-0.21|||>|0.05|TWO_SIDED|95.0|-0.53|0.12|||Pair-wise comparisons|||Week 2, Treatment Effect||0.12|-0.53|>0.05
71819028|NCT00962585|143141510|SUPERIORITY_OR_OTHER||LS means difference|-0.23|||>|0.05|TWO_SIDED|95.0|-0.55|0.09|||Pair-wise comparisons|||Week 2, Treatment Effect||0.09|-0.55|>0.05
71819029|NCT00962585|143141510|SUPERIORITY_OR_OTHER||LS means difference|0.03|||>|0.05|TWO_SIDED|95.0|-0.28|0.35|||Pair-wise comparisons|||Week 2, Treatment Effect||0.35|-0.28|>0.05
71819030|NCT00962585|143141510|SUPERIORITY_OR_OTHER||LS means difference|-0.26|||>|0.05|TWO_SIDED|95.0|-0.54|0.02|||Pair-wise comparisons|||Week 4, Treatment Effect||0.02|-0.54|>0.05
71819031|NCT00962585|143141510|SUPERIORITY_OR_OTHER||LS means difference|-0.13|||>|0.05|TWO_SIDED|95.0|-0.4|0.14|||Pair-wise comparisons|||Week 4, Treatment Effect||0.14|-0.40|>0.05
71819032|NCT00962585|143141510|SUPERIORITY_OR_OTHER||LS means difference|-0.24|||>|0.05|TWO_SIDED|95.0|-0.51|0.03|||Pair-wise comparisons|||Week 4, Treatment Effect||0.03|-0.51|>0.05
71882964|NCT00781456|143285028|SUPERIORITY_OR_OTHER|||||||0.457|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the first month of treatment.||||0.457
71882965|NCT00781456|143285028|SUPERIORITY_OR_OTHER|||||||0.361|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the second month of treatment.||||0.361
71882966|NCT00781456|143285028|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the third month of treatment.||||0.018
71882967|NCT00781456|143285028|SUPERIORITY_OR_OTHER|||||||0.709|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.||||0.709
71882968|NCT00783094|143285053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.201|TWO_SIDED|95.0|-1.8|0.4|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.4|-1.8|0.201
71882969|NCT00783094|143285053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.062|TWO_SIDED|95.0|-2.2|0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-2.2|0.062
71882970|NCT00783094|143285054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.356|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-0.7|0.356
71882971|NCT00783094|143285054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.487|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.3|-0.6|0.487
71882972|NCT00783094|143285055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.228|TWO_SIDED|95.0|-1.3|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo|||0.3|-1.3|0.228
71901091|NCT00051558|143324277|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901092|NCT00051558|143324277|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
71901093|NCT00051558|143324277|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.||||0.011
71901094|NCT00051558|143324277|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
71819033|NCT00962585|143141511|SUPERIORITY_OR_OTHER|||||||0.6375||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal Maturation Index) = Baseline (Vaginal Maturation Index) + Treatment + Site + Weeks + Treatment x Weeks||Vaginal maturation index = 0.2 x (% parabasal cells) + 0.6 x(% intermediate cells) + 1.0 x (% superficial cells)||||0.6375
71819034|NCT00962585|143141511|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.57|6.42|||Pair-wise comparisons|||Week 2, Treatment Effect||6.42|-9.57|>0.05
71819035|NCT00962585|143141511|SUPERIORITY_OR_OTHER||LS means difference|-1.58|||>|0.05|TWO_SIDED|95.0|-9.63|6.46|||Pair-wise comparisons|||Week 2, Treatment Effect||6.46|-9.63|>0.05
71901095|NCT00051558|143324278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||<0.001
71901096|NCT00051558|143324278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901097|NCT00051558|143324278|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901098|NCT00051558|143324278|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.||||0.006
71901099|NCT00051558|143324278|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
71901100|NCT00051558|143324279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901101|NCT00051558|143324279|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.015
71901102|NCT00051558|143324279|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.002
71901103|NCT00051558|143324279|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901104|NCT00051558|143324280|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.011
71901105|NCT00051558|143324280|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||0.009
71901106|NCT00051558|143324280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901107|NCT00051558|143324280|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment\*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\*visit.||||<0.001
71901108|NCT00051558|143324281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901109|NCT00051558|143324281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901110|NCT00051558|143324281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901111|NCT00051558|143324281|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901112|NCT00051558|143324282|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901113|NCT00051558|143324282|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901114|NCT00051558|143324282|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.004
71901115|NCT00051558|143324282|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||0.013
71901116|NCT00051558|143324283|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901117|NCT00051558|143324283|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901118|NCT00051558|143324283|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901119|NCT00051558|143324283|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901120|NCT00051558|143324284|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901121|NCT00051558|143324284|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901122|NCT00051558|143324284|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901123|NCT00051558|143324284|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901124|NCT00051558|143324285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901125|NCT00051558|143324285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901126|NCT00051558|143324285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901127|NCT00051558|143324285|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value at Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.||||||<0.001
71901128|NCT00051558|143324286|SUPERIORITY_OR_OTHER|||||||0.212||95.0||||p-value for Any Fracture|Cochran-Mantel-Haenszel|||||||0.212
71901129|NCT00051558|143324286|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||p-value for Nonvertebral Fracture|Cochran-Mantel-Haenszel|||||||0.843
71819036|NCT00962585|143141511|SUPERIORITY_OR_OTHER||LS means difference|-1.59|||>|0.05|TWO_SIDED|95.0|-9.66|6.47|||Pair-wise comparisons|||Week 2, Treatment Effect||6.47|-9.66|>0.05
71819037|NCT00962585|143141511|SUPERIORITY_OR_OTHER||LS means difference|-0.31|||>|0.05|TWO_SIDED|95.0|-6.73|6.11|||Pair-wise comparisons|||Week 4, Treatment Effect||6.11|-6.73|>0.05
71819038|NCT00962585|143141511|SUPERIORITY_OR_OTHER||LS means difference|-6.14|||>|0.05|TWO_SIDED|95.0|-12.36|0.07|||Pair-wise comparisons|||Week 4, Treatment Effect||0.07|-12.36|>0.05
71819039|NCT00962585|143141511|SUPERIORITY_OR_OTHER||LS means difference|-2.88|||>|0.05|TWO_SIDED|95.0|-9.05|3.28|||Pair-wise comparisons|||Week 4, Treatment Effect||3.28|-9.05|>0.05
71819040|NCT00962585|143141512|SUPERIORITY_OR_OTHER|||||||0.0681||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Estradiol) = Baseline (Estradiol) + Treatment + Site + Weeks + Treatment x Weeks||||||0.0681
71850695|NCT00882050|143215107|SUPERIORITY|Demographic data analyzed with nominal data tested by chi-square, ordinal data by Mann-Whitney, and normal data by t-test. Further, a linear regression analysis to determine the effect of intervention dose on glucose level and typical confounders such as age, weight, and type of surgery was completed. Adverse and SAEs were analyzed by chi-square for occurrence.||||||0.05||||||Due to have 3 trial groups our p value was adjusted for multiple comparisons as a a priori threshold (if a single comparison) was 0.05.|Regression, Logistic|The regression (see above) is a secondary analysis. Groups had been stratified on diabetic (y/n) to balance this potential confounder||Primary t tests of glucose between the 3 groups at 90 minutes post. Secondary MANOVA to determine the effect over time. Change in mean glucose of 20 mg/dl between all groups detectable by 18 subjects per group assuming a SD of 20mg/dl., an 82% power with an alpha of 0.05. Because we tested interventions against the placebo arm, we increased our subjects to overcome loss of power. 23 per group will provide 80% power assuming a reduced alpha of 0.01 to accommodate the multiple testing issues.||||0.05
71850696|NCT02367794|143215108|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0006|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0006
71850697|NCT02367794|143215109|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1581|TWO_SIDED|95.0|0.73|1.05|||Log Rank|||||1.05|0.73|0.1581
71850698|NCT02367794|143215110|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.876||||0.4451|TWO_SIDED|95.0|0.623|1.231|||Log Rank|||Teff \>=-1.91 in ITT||1.231|0.623|0.4451
71850699|NCT02367794|143215110|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.941||||0.7343|TWO_SIDED|95.0|0.664|1.335|||Log Rank|||Teff \>=-1.91 in ITT||1.335|0.664|0.7343
71901130|NCT00051558|143324286|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value for Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.007
71819041|NCT00962585|143141512|SUPERIORITY_OR_OTHER||LS means difference|35.32|||>|0.05|TWO_SIDED|95.0|1.75|68.9|||Pair-wise comparisons|||Week 2, Treatment Effect||68.90|1.75|>0.05
71819042|NCT00962585|143141512|SUPERIORITY_OR_OTHER||LS means difference|3.61|||>|0.05|TWO_SIDED|95.0|-29.12|36.34|||Pair-wise comparisons|||Week 2, Treatment Effect||36.34|-29.12|>0.05
71819043|NCT00962585|143141512|SUPERIORITY_OR_OTHER||LS means difference|-4.58|||>|0.05|TWO_SIDED|95.0|-37.39|28.23|||Pair-wise comparisons|||Week 2, Treatment Effect||28.23|-37.39|>0.05
71819044|NCT00962585|143141512|SUPERIORITY_OR_OTHER||LS means difference|22.12|||>|0.05|TWO_SIDED|95.0|-23.56|67.8|||Pair-wise comparisons|||Week 4, Treatment Effect||67.80|-23.56|>0.05
71819045|NCT00962585|143141512|SUPERIORITY_OR_OTHER||LS means difference|7.8|||>|0.05|TWO_SIDED|95.0|-36.7|52.29|||Pair-wise comparisons|||Week 4, Treatment Effect||52.29|-36.70|>0.05
71819046|NCT00962585|143141512|SUPERIORITY_OR_OTHER||LS means difference|-22.74|||>|0.05|TWO_SIDED|95.0|-67.44|21.96|||Pair-wise comparisons|||Week 4, Treatment Effect||21.96|-67.44|>0.05
71819047|NCT00962585|143141516|SUPERIORITY_OR_OTHER|||||||0.0475||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0475
71850700|NCT02367794|143215110|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.942||||0.661|TWO_SIDED|95.0|0.72|1.232|||Log Rank|||Teff \<-1.91 Negative in ITT||1.232|0.720|0.6610
71850701|NCT02367794|143215110|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.253||||0.0893|TWO_SIDED|95.0|0.965|1.627|||Log Rank|||Teff \<-1.91 Negative in ITT||1.627|0.965|0.0893
71850702|NCT02367794|143215111|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61||||0.0006|TWO_SIDED|95.0|0.46|0.81|||Log Rank|||Teff\>=-1.91||0.81|0.46|0.0006
71850703|NCT02367794|143215111|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\>=-1.91||1.33|0.84|0.630
71850704|NCT02367794|143215111|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.88||||0.258|TWO_SIDED|95.0|0.7|1.1|||Log Rank|||Teff\<-1.91||1.10|0.70|0.258
71850705|NCT02367794|143215111|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.06||||0.63|TWO_SIDED|95.0|0.84|1.33|||Log Rank|||Teff\<-1.91||1.33|0.84|0.630
71850706|NCT02367794|143215112|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|||||0.72|0.40|<.0001
71901131|NCT00051558|143324286|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||p-value for Clinical Vertebral Fracture|Cochran-Mantel-Haenszel|||||||0.037
71901132|NCT00051558|143324286|SUPERIORITY_OR_OTHER|||||||0.256||95.0||||p-value for Nonvertebral Fragility Fracture|Cochran-Mantel-Haenszel|||||||0.256
71901133|NCT01441440|143324309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.031|TWO_SIDED|95.0|0.14|2.87||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.87|0.14|0.031
71901134|NCT01441440|143324309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.12||||0.106|TWO_SIDED|95.0|-0.24|2.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||2.48|-0.24|0.106
71819048|NCT00962585|143141516|SUPERIORITY_OR_OTHER|||||||0.0258||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0258
71819049|NCT00962585|143141516|SUPERIORITY_OR_OTHER|||||||0.0281||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.0281
71819050|NCT00962585|143141516|SUPERIORITY_OR_OTHER|||||||0.0645||95.0|||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.0645
71819051|NCT00962585|143141517|SUPERIORITY_OR_OTHER|||||||0.0097||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0097
71819052|NCT00962585|143141518|SUPERIORITY_OR_OTHER|||||||0.4352||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.4352
71819053|NCT00962585|143141518|SUPERIORITY_OR_OTHER|||||||0.26||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.2600
71819054|NCT00962585|143141518|SUPERIORITY_OR_OTHER|||||||0.7037||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4||||||0.7037
71819055|NCT00962585|143141518|SUPERIORITY_OR_OTHER|||||||0.7155|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.||||0.7155
71819056|NCT00962585|143141519|SUPERIORITY_OR_OTHER|||||||0.0381||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4||||||0.0381
71819057|NCT02254421|143141521|SUPERIORITY||Treatment difference|-0.02||||0.94|TWO_SIDED|95.0|-0.62|0.57||P-value was calculated from the ANCOVA model including baseline values and stratification factors.|ANCOVA|||||0.57|-0.62|0.94
71819058|NCT02254421|143141522|SUPERIORITY|||||||0.84||||||P-value was calculated from the negative binomial model with stratification factors as covariates.|Negative binomial|||||||0.84
71819059|NCT02254421|143141523|SUPERIORITY|||||||0.98||||||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.98
71819060|NCT02254421|143141524|SUPERIORITY|||||||0.19||||||P-value was calculated from the CMH test stratified by stratification factors.|Cochran-Mantel-Haenszel|||||||0.19
71819061|NCT00390455|143141583|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The null hypothesis then is that the hazard ratio of the two treatment arms is 1.0; the alternative hypothesis is that the hazard ratio of the control to the experimental regimen is 1.5 (0.67). The test of these hypotheses is one-sided (alpha = 0.025), and interim analyses will be used to stop for futility and superiority. Under these assumptions, there is at least 90% power to detect the stated difference in median PFS between the two treatment arms.|Hazard Ratio (HR)|1.04||||0.37|TWO_SIDED|95.0|0.82|1.33||Tests were stratified by prior tamoxifen therapy (yes/no) and bone disease only (yes/no).|Log Rank|||||1.33|0.82|0.37
71850707|NCT02367794|143215112|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61||||0.0018|TWO_SIDED|95.0|0.45|0.84|||Log Rank|||||0.84|0.45|0.0018
71819062|NCT04076020|143141597|SUPERIORITY|||||||0.99||||||Results presented from Wilcoxon-Mann-Whitney test with PDC as the dependent variable.|Wilcoxon (Mann-Whitney)|||Proportion of days covered (PDC) at 12 months. A sample size of 119 in each study arm enabled us to detect a minimum difference in PDC of 11.7% with 85% power (assuming a standard deviation=30%). Our power calculations assume use of 2-sided tests with 0.05 significance level.||||0.99
71819063|NCT04076020|143141597|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Proportion of days covered (PDC) analyzed as a binary variable with optimal adherence determined as ≥0.80) variables using logistic regression and adjustment for trial stratification factors. Our power calculations assume use of 2-sided tests with 0.05 significance level.||||<0.05
71819064|NCT04076020|143141598|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||Difference in self-reported adherence reported across baseline, 4-, 8-, and 12-month visits using generalized estimating equations and adjusted for trial stratification factors.||||<0.05
71819065|NCT02524054|143141606|SUPERIORITY|||||||0.35||||||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.||||0.35
71819066|NCT02524054|143141607|SUPERIORITY||||||<|0.001||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.|t-test, 2 sided|||||||<0.001
71850708|NCT02367794|143215113|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
71850709|NCT02367794|143215113|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.48|0.77|||Log Rank|||||0.77|0.48|<.0001
71901135|NCT01441440|143324310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.88||||0.008|TWO_SIDED|95.0|0.77|5.0||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||5.00|0.77|0.008
71901136|NCT01441440|143324310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64||||0.014|TWO_SIDED|95.0|0.54|4.74||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||4.74|0.54|0.014
71901137|NCT01441440|143324311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26||||0.025|TWO_SIDED|95.0|0.03|0.49||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.49|0.03|0.025
71819067|NCT03537261|143141611|SUPERIORITY||Mean Difference (Net)|5.8||||0.11|TWO_SIDED|95.0|-1.4|13.1|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||13.1|-1.4|0.11
71819068|NCT03537261|143141612|SUPERIORITY||Mean Difference (Net)|-2.2||||0.4|TWO_SIDED|95.0|-7.4|3.0|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||3.0|-7.4|0.40
71819069|NCT03537261|143141613|SUPERIORITY||Mean Difference (Net)|0.6||||0.72|TWO_SIDED|95.0|-2.9|4.2|||Regression, Linear|Repeated measures linear regression controlling for score at screening visit|(P-CPI training change) - (waitlist change)|||4.2|-2.9|0.72
71819070|NCT02500979|143141708|SUPERIORITY_OR_OTHER||Least squares mean difference|-21.5|STANDARD_ERROR_OF_MEAN|7.88||0.0118|TWO_SIDED|95.0|-37.8|-5.2|||Linear mixed-effects model|||||-5.2|-37.8|0.0118
71819071|NCT02500979|143141709|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-7.897||||0.0013|TWO_SIDED|95.0|-12.356|-3.438|||Linear mixed effects model|||||-3.438|-12.356|0.0013
71819072|NCT02500979|143141710|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-5.277||||0.0091|TWO_SIDED|95.0|-9.175|-1.378|||Linear mixed effects model|||||-1.378|-9.175|0.0091
71819073|NCT02500979|143141711|SUPERIORITY_OR_OTHER||LS mean difference (pramlintide-placebo)|-4.435||||0.0057|TWO_SIDED|95.0|-7.445|-1.424|||Linear mixed effects model|||||-1.424|-7.445|0.0057
71819074|NCT02500979|143141712|SUPERIORITY_OR_OTHER||Least squares mean difference|-28733.0|STANDARD_ERROR_OF_MEAN|4163.6|<|0.0001|TWO_SIDED|95.0|-37326.0|-20139.0|||Linear mixed-effects model|||||-20139|-37326|<0.0001
71819075|NCT02500979|143141713|SUPERIORITY_OR_OTHER||LS mean difference|-28.418||||0.0258|TWO_SIDED|95.0|-53.099|-3.737|||Linear mixed-effects model|||||-3.737|-53.099|0.0258
71819076|NCT02500979|143141715|SUPERIORITY_OR_OTHER||LS Mean Ratio (Pramlintide/Placebo)|1.31||||0.0456|TWO_SIDED|95.0|1.01|1.7|||Linear mixed-effects model|||||1.70|1.01|0.0456
71901138|NCT01441440|143324311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.032|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.032
71901139|NCT01441440|143324312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18||||0.004|TWO_SIDED|95.0|0.39|1.97||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||1.97|0.39|0.004
71901140|NCT01441440|143324312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06||||0.008|TWO_SIDED|95.0|0.28|1.85||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.85|0.28|0.008
71901141|NCT01441440|143324313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5||||0.004|TWO_SIDED|95.0|0.48|2.53||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||2.53|0.48|0.004
71901142|NCT01441440|143324313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.137|TWO_SIDED|95.0|-0.25|1.79||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||1.79|-0.25|0.137
71901143|NCT01441440|143324314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.073|TWO_SIDED|95.0|-0.02|0.45||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group|||0.45|-0.02|0.073
71901144|NCT01441440|143324314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.034|TWO_SIDED|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group|||0.48|0.02|0.034
71819077|NCT02500979|143141716|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|0.951||||0.1015|TWO_SIDED|95.0|0.896|1.011|||Linear mixed-effects model|||||1.011|0.896|0.1015
71819078|NCT02500979|143141718|SUPERIORITY_OR_OTHER||LS mean ratio (pramlintide/placebo)|1.085||||0.373|TWO_SIDED|95.0|0.901|1.307|||Linear mixed effects model|||||1.307|0.901|0.3730
71819079|NCT00672958|143141723|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.74||||0.407|TWO_SIDED|95.0|-2.48|1.01||Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.||Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.||1.01|-2.48|0.407
71819080|NCT00672958|143141724|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.901|TWO_SIDED|95.0|-0.97|1.1|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Comparison of change from Baseline at Week 1.||1.10|-0.97|0.901
71819081|NCT00672958|143141724|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26||||0.701|TWO_SIDED|95.0|-1.07|1.59|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 2||1.59|-1.07|0.701
71819082|NCT00672958|143141724|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68||||0.356|TWO_SIDED|95.0|-2.11|0.76|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 3||0.76|-2.11|0.356
71819083|NCT00672958|143141724|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33||||0.67|TWO_SIDED|95.0|-1.85|1.19|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 4||1.19|-1.85|0.670
71819084|NCT00672958|143141724|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87||||0.304|TWO_SIDED|95.0|-2.52|0.79|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 5||0.79|-2.52|0.304
71819085|NCT01380990|143141736|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
71819086|NCT01380990|143141736|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
71901145|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-5.4|3.7||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.7|-5.4|
71901146|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-5.5||||||95.0|-14.2|3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.3|-14.2|
71901147|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-3.7|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.8|-3.7|
71901148|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.9||||||95.0|-6.9|0.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.7|-6.9|
71901149|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-3.0|3.0||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-3.0|
71901150|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-2.5||||||95.0|-6.1|0.6||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.6|-6.1|
71901151|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-6.3||||||95.0|-12.1|-0.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||-0.7|-12.1|
71901152|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|3.4||||||95.0|-0.9|7.9||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||7.9|-0.9|
71901153|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-4.1|1.1||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-4.1|
71901154|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|1.7||||||95.0|-3.0|6.4||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.4|-3.0|
71901155|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-5.8|6.7||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||6.7|-5.8|
71901156|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.8||||||95.0|-3.2|1.2||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-3.2|
71901157|NCT00366548|143324321|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-1.3||||||95.0|-3.6|0.3||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||0.3|-3.6|
71901158|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||1.9|-2.1|
71901159|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.7|2.6||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.||2.6|-1.7|
71901160|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
71901161|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.9|-2.1|
71901162|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-1.2|2.3||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.3|-1.2|
71901163|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.4||||||95.0|-2.0|2.9||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||2.9|-2.0|
71901164|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.9||||||95.0|-3.4|1.1||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-3.4|
71901165|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.8||||||95.0|-0.8|3.0||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||3.0|-0.8|
71901166|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.6||||||95.0|-3.7|4.9||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||4.9|-3.7|
71901167|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.1|-2.4|
71901168|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|-0.4||||||95.0|-2.4|1.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.2|-2.4|
71901169|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
71901170|NCT00366548|143324322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups \> -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||1.6|-1.7|
71901171|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
71901172|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.9||||||95.0|0.72|1.14||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.72|
71901173|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.85|1.1||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.85|
71901174|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.79|1.15||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.79|
71901175|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.98||||||95.0|0.86|1.13||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.86|
71901176|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.72|0.97||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated||0.97|0.72|
71901177|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.71|0.98||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated||0.98|0.71|
71901178|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.94||||||95.0|0.81|1.1||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.81|
71819087|NCT01380990|143141736|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients alive at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
71819088|NCT01380990|143141736|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819089|NCT01380990|143141736|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819090|NCT01380990|143141736|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients alive at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of patients alive at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819091|NCT01380990|143141737|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
71819092|NCT01380990|143141737|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
71850710|NCT02367794|143215114|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.725||||0.0518|TWO_SIDED|95.0|0.524|1.004|||Log Rank|||||1.004|0.524|0.0518
71850711|NCT02367794|143215114|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.832||||0.2841|TWO_SIDED|95.0|0.594|1.165|||Log Rank|||||1.165|0.594|0.2841
71850712|NCT02367794|143215115|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.871||||0.2956|TWO_SIDED|95.0|0.671|1.129|||Log Rank|||||1.129|0.671|0.2956
71850713|NCT02367794|143215115|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.861||||0.2473|TWO_SIDED|95.0|0.668|1.109|||Log Rank|||||1.109|0.668|0.2473
71850714|NCT02367794|143215116|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.41||||0.0248|TWO_SIDED|95.0|1.04|1.91|||Cochran-Mantel-Haenszel|||||1.91|1.04|0.0248
71850715|NCT02367794|143215116|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|1.4||||0.0308|TWO_SIDED|95.0|1.03|1.9|||Cochran-Mantel-Haenszel|||||1.90|1.03|0.0308
71850716|NCT02367794|143215117|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.408|0.689|||Log Rank|||||0.689|0.408|<.0001
71850717|NCT02367794|143215117|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.64||||0.0007|TWO_SIDED|95.0|0.493|0.831|||Log Rank|||||0.831|0.493|0.0007
71850718|NCT02367794|143215118|SUPERIORITY||Difference in Event Free Rate|0.06||||0.9871|TWO_SIDED|95.0|-7.48|7.61|||Z-test|||Event Free Rate (%) at Year 1||7.61|-7.48|0.9871
71850719|NCT02367794|143215118|SUPERIORITY||Difference in Event Free Rate|5.93||||0.1133|TWO_SIDED|95.0|-1.41|13.26|||Z-test|||Event Free Rate (%) at Year 2||13.26|-1.41|0.1133
71901179|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.93||||||95.0|0.83|1.04||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.83|
71901180|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.83|1.13||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.83|
71901181|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.81|
71901182|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|1.05||||||95.0|0.93|1.18||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.93|
71850720|NCT02367794|143215118|SUPERIORITY||Difference in Event Free Rate|-3.97||||0.3072|TWO_SIDED|95.0|-11.6|3.65|||Z-test|||Event Free Rate (%) at Year 1||3.65|-11.60|0.3072
71850721|NCT02367794|143215118|SUPERIORITY||Difference in Event Free Rate|1.21||||0.743|TWO_SIDED|95.0|-6.01|8.42|||Z-test|||Event Free Rate (%) at Year 2||8.42|-6.01|0.7430
71850722|NCT02367794|143215119|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.797||||0.0461|TWO_SIDED|95.0|0.638|0.996|||Log Rank|||||0.996|0.638|0.0461
71850723|NCT02367794|143215119|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.04||||0.7295|TWO_SIDED|95.0|0.834|1.296|||Log Rank|||||1.296|0.834|0.7295
71850724|NCT02367794|143215120|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.828||||0.0942|TWO_SIDED|95.0|0.663|1.033|||Log Rank|||||1.033|0.663|0.0942
71850725|NCT02367794|143215120|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.968||||0.7709|TWO_SIDED|95.0|0.776|1.207|||Log Rank|||||1.207|0.776|0.7709
71850726|NCT02367794|143215122|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.93||||0.4007|TWO_SIDED|95.0|0.784|1.102|||Log Rank|||||1.102|0.784|0.4007
71850727|NCT00091572|143215148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.2663||95.0|0.8|1.06|||Log Rank||Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.|||1.06|0.80|0.2663
71850728|NCT00091572|143215149|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9999||95.0|0.86|1.17|||Log Rank||Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.|||1.17|0.86|0.9999
71850729|NCT00091572|143215150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.0718||95.0|0.97|2.12|||Cochran-Mantel-Haenszel||Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.|||2.12|0.97|0.0718
71901183|NCT00366548|143324325|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) \> 0.5 (2-fold criterion).|Difference|0.91||||||95.0|0.8|1.04||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated||1.04|0.80|
71901184|NCT03463941|143324336|OTHER||||||||||||||||||descriptive|||
71850730|NCT02591056|143215203|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|t=+7.45; df=26||||||<0.0001
71850731|NCT01159600|143215204|SUPERIORITY_OR_OTHER||Mean difference|-1.63|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.17|-1.08||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.08|-2.17|<0.0001
71850732|NCT01159600|143215204|SUPERIORITY_OR_OTHER||Mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.56|-1.46||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.46|-2.56|<0.0001
71850733|NCT01159600|143215204|SUPERIORITY_OR_OTHER||Mean difference|-1.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.25|-1.28||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.28|-2.25|<0.0001
71850734|NCT01159600|143215204|SUPERIORITY_OR_OTHER||Mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|97.5|-2.48|-1.5||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.||-1.50|-2.48|<0.0001
71901185|NCT03463941|143324337|OTHER||||||||||||||||||descriptive|||
71901186|NCT03463941|143324339|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71901187|NCT03463941|143324340|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71901188|NCT03463941|143324341|OTHER||||||||||||||||||descriptive|||
71901189|NCT03463941|143324342|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71901190|NCT01111539|143324364|SUPERIORITY||Treatment Difference|-1.0|||=|0.644|TWO_SIDED|95.0|-5.2|3.3|||ANCOVA|||The statistical analyses was performed by fitting an analysis of covariance (ANCOVA) model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model included baseline MADRS Total Score as a covariate and treatment as the main effect.||3.3|-5.2|=0.644
71819093|NCT01380990|143141737|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||||
71819094|NCT01380990|143141737|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819095|NCT01380990|143141737|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819096|NCT01380990|143141737|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with EvFS at 1-year post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 1-year post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819097|NCT01380990|143141742|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||=|0.002|||||||Mixed Models Analysis|||"Mixed-Effect Model Repeated Measure (MMRM) Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study subjects group."||||= 0.002
71819098|NCT01380990|143141742|OTHER|Model includes fixed effects for visit and Baseline, subject as random effect, with compound symmetry covariance structure. Observations with a value of 0 were imputed as 0.01. Model analyses log transformed data, so the adjusted mean refers to the geometric mean ratio between Month 12 and Baseline.|||||<|0.001|||||||Mixed Models Analysis|||"MMRM Analysis of Change from Baseline to Month 12 in Log-Transformed CD3+ T Cell count (OTL-101\*) for OTL-101\* on-study and CUP subjects group."||||< 0.001
71819099|NCT01380990|143141747|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||||
71819100|NCT01380990|143141747|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-22.41|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||48.25|-22.41|
71819101|NCT01380990|143141747|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-28.1|34.23||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study subjects.||34.23|-28.10|
71819102|NCT01380990|143141747|SUPERIORITY||Difference in percentages|0.0|||||TWO_SIDED|||||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||||
71819103|NCT01380990|143141747|SUPERIORITY||Difference in percentages|11.11|||||TWO_SIDED|95.0|-10.01|48.25||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||48.25|-10.01|
71819104|NCT01380990|143141747|SUPERIORITY||Difference in percentages|7.14|||||TWO_SIDED|95.0|-12.91|33.87||||||Percentage of patients with OS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with OS at 3-years post-treatment with OTL-101\* (on study and CUP). Results are reported as percentage difference in OS of historical control group from OTL-101\* on-study and CUP subjects.||33.87|-12.91|
71819105|NCT01380990|143141748|SUPERIORITY||||||=|0.645|||||||Log Rank|||||||=0.645
71819106|NCT01380990|143141748|SUPERIORITY||||||=|0.299|||||||Log Rank|||||||=0.299
71819107|NCT01380990|143141748|SUPERIORITY||||||=|0.2|||||||Log Rank|||||||= 0.2
71819108|NCT01380990|143141748|SUPERIORITY||||||=|0.028|||||||Log Rank|||||||= 0.028
71819109|NCT01380990|143141748|SUPERIORITY||||||=|0.259|||||||Log Rank|||||||= 0.259
71819110|NCT01380990|143141748|SUPERIORITY||||||=|0.044|||||||Log Rank|||||||= 0.044
71819111|NCT01380990|143141748|SUPERIORITY||Difference in percentages|10.0|||||TWO_SIDED|95.0|-32.05|61.97||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||61.97|-32.05|
71819112|NCT01380990|143141748|SUPERIORITY||Difference in percentages|30.0|||||TWO_SIDED|95.0|-10.72|65.87||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||65.87|-10.72|
71819113|NCT01380990|143141748|SUPERIORITY||Difference in percentages|23.33|||||TWO_SIDED|95.0|-15.24|54.59||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study subjects.||54.59|-15.24|
71850735|NCT01159600|143215205|SUPERIORITY_OR_OTHER||Mean difference|-7.65|STANDARD_ERROR_OF_MEAN|2.74||0.0055|TWO_SIDED|97.5|-13.81|-1.48||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-1.48|-13.81|0.0055
71850736|NCT01159600|143215205|SUPERIORITY_OR_OTHER||Mean difference|-12.37|STANDARD_ERROR_OF_MEAN|2.75|<|0.0001|TWO_SIDED|97.5|-18.55|-6.19||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.19|-18.55|<0.0001
71850737|NCT01159600|143215205|SUPERIORITY_OR_OTHER||Mean difference|-10.02|STANDARD_ERROR_OF_MEAN|2.53|<|0.0001|TWO_SIDED|97.5|-15.72|-4.32||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-4.32|-15.72|<0.0001
71850738|NCT01159600|143215205|SUPERIORITY_OR_OTHER||Mean difference|-13.06|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|97.5|-19.15|-6.98||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose||-6.98|-19.15|<0.0001
71850739|NCT01159600|143215206|SUPERIORITY_OR_OTHER||Mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.72|-0.42||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.42|-0.72|<0.0001
71850740|NCT01159600|143215206|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.48||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.48|-0.79|<0.0001
71850741|NCT01159600|143215206|SUPERIORITY_OR_OTHER||Mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.79|-0.49||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.49|-0.79|<0.0001
71882973|NCT00783094|143285055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.033|TWO_SIDED|95.0|-1.7|-0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.1|-1.7|0.033
71901191|NCT01111539|143324364|SUPERIORITY||Treatment Difference|-3.7|||=|0.08|TWO_SIDED|95.0|-7.8|0.4|||ANCOVA|||The statistical analyses will be performed by fitting an ANCOVA model to the change from baseline data (Week 8 Visit) for the MADRS Total Score at the Week 14 visit (LOCF). The model will include baseline MADRS Total Score as a covariate and treatment as the main effect.||0.4|-7.8|=0.080
71901192|NCT01111539|143324365|SUPERIORITY||Treatment Difference|-0.3|||=|0.366|TWO_SIDED|95.0|-0.8|0.3|||Cochran-Mantel-Haenszel|||||0.3|-0.8|=0.366
71901193|NCT01111539|143324365|SUPERIORITY||Treatment Difference|-0.4|||=|0.138|TWO_SIDED|95.0|-0.9|0.1|||Cochran-Mantel-Haenszel|||||0.1|-0.9|=0.138
71901194|NCT01111539|143324366|SUPERIORITY||Treatment Difference|0.0|||=|0.995|TWO_SIDED|95.0|-1.2|1.2|||ANCOVA|||||1.2|-1.2|=0.995
71901195|NCT01111539|143324366|SUPERIORITY||Treatment Difference|-0.9|||=|0.118|TWO_SIDED|95.0|-2.1|0.2|||ANCOVA|||||0.2|-2.1|=0.118
71819114|NCT01380990|143141748|SUPERIORITY||Difference in percentages|15.0|||||TWO_SIDED|95.0|-13.7|63.54||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (without MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||63.54|-13.70|
71819115|NCT01380990|143141748|SUPERIORITY||Difference in percentages|35.0|||||TWO_SIDED|95.0|2.29|68.45||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (with MRD) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||68.45|2.29|
71819116|NCT01380990|143141748|SUPERIORITY||Difference in percentages|28.33|||||TWO_SIDED|95.0|2.04|56.36||||||Percentage of patients with EvFS at 3-years post-treatment in the historical control groups (all historical controls) were compared to the percentage of study patients with EvFS at 3-years post-treatment with OTL-101\* (on-study and CUP). Results are reported as percentage difference in EvFS of historical control group from OTL-101\* on-study and CUP subjects.||56.36|2.04|
71819117|NCT04267614|143141756|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71819118|NCT04267614|143141757|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71819119|NCT04267614|143141758|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71819120|NCT04267614|143141759|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71819121|NCT00305864|143141782|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Log Rank|One-sided||A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.||||0.27
71819122|NCT03881059|143141794|SUPERIORITY||Slope Coefficient of Dose|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Regression, Logistic|||||0.17|0.05|<0.001
71819123|NCT02065570|143141838|SUPERIORITY||Adjusted risk difference|0.3||||0.939|TWO_SIDED|95.0|-8.1|8.8||Adjusted for previous infliximab use (or prior anti-tumor necrosis factor (TNF) use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.8|-8.1|0.939
71819124|NCT02065570|143141839|SUPERIORITY||Adjusted risk difference|3.2||||0.462|TWO_SIDED|95.0|-5.3|11.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.7|-5.3|0.462
71901196|NCT03628417|143324372|NON_INFERIORITY|Examined the objective response rate (ORR) that there was 20% difference between the 2 treatment arms at day 180. With a significance level of 0,05 and a power of 80% the study required 28 evaluable metastases.|Odds Ratio (OR)|0.4489629||||0.3|TWO_SIDED|95.0|-13.3|53.3|||Fisher Exact|||After reviewing existing data from electrochemotherapy with intratumoral bleomycin on small cutaneous metastases ≤3cm , we estimated the expected response rate for electrochemotherapy to 85%. We have no clinical results for the treatment of calcium electroporation, but on the basis of preclinical studies, we decided to accept a difference in response of 20%. All statistical analysis were done using IBM SPSS v24.||53.30|-13.30|0.30
71901197|NCT04102098|143324471|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.012|TWO_SIDED|95.0|0.56|0.93|||Log Rank|||Stratification factors include geographic region (Asia Pacific excluding Japan vs. rest of world) and High risk features/curative procedure (Ablation vs. Resection with 1 high risk feature vs. Resection with 2 or more high risk features).||0.93|0.56|0.0120
71901198|NCT04742907|143324483|SUPERIORITY||Cox Proportional Hazard|0.91||||0.767|TWO_SIDED|90.0|0.74|1.12||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: hazard ratio (HR) = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and confidence intervals (CIs) are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.12|0.74|0.767
71901199|NCT04742907|143324483|SUPERIORITY||Cox Proportional Hazard|1.17||||0.107|TWO_SIDED|90.0|0.95|1.44||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|||1.44|0.95|0.107
71901200|NCT04742907|143324484|SUPERIORITY||Cox Proportional Hazard|0.9||||0.78|TWO_SIDED|90.0|0.71|1.13||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.13|0.71|0.780
71901201|NCT04742907|143324484|SUPERIORITY||Cox Proportional Hazard|1.06||||0.33|TWO_SIDED|90.0|0.84|1.34||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to GI-2||1.34|0.84|0.330
71901202|NCT04742907|143324484|SUPERIORITY||Cox Proportional Hazard|0.9||||0.788|TWO_SIDED|90.0|0.73|1.11||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.11|0.73|0.788
71819125|NCT02065570|143141841|SUPERIORITY||Adjusted risk difference|4.6||||0.269|TWO_SIDED|95.0|-3.6|12.8||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||12.8|-3.6|0.269
71819126|NCT02065570|143141842|SUPERIORITY||Adjusted risk difference|1.8||||0.61|TWO_SIDED|95.0|-5.1|8.7||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.7|-5.1|0.610
71819127|NCT02065570|143141843|SUPERIORITY||Adjusted risk difference|11.2||||0.008|TWO_SIDED|95.0|2.9|19.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||19.6|2.9|0.008
71819128|NCT02065570|143141844|SUPERIORITY||Adjusted risk difference|6.0||||0.336|TWO_SIDED|95.0|-6.2|18.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||18.2|-6.2|0.336
71819129|NCT02065570|143141845|SUPERIORITY||Adjusted risk difference|1.5||||0.694|TWO_SIDED|95.0|-6.1|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-6.1|0.694
71819130|NCT02065570|143141846|SUPERIORITY||LS Mean of Difference|6.8||||0.946|TWO_SIDED|95.0|-192.3|205.9|||Cochran-Mantel-Haenszel|||||205.9|-192.3|0.946
71819131|NCT02065570|143141847|SUPERIORITY||Adjusted risk difference|4.0||||0.293|TWO_SIDED|95.0|-3.5|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-3.5|0.293
71819132|NCT02065570|143141848|SUPERIORITY||Adjusted risk difference|3.0||||0.304|TWO_SIDED|95.0|-2.7|8.6||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||8.6|-2.7|0.304
71819133|NCT02065570|143141849|SUPERIORITY||Adjusted risk difference|4.2||||0.092|TWO_SIDED|95.0|-0.7|9.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||9.1|-0.7|0.092
71819134|NCT02065570|143141850|SUPERIORITY||Adjusted risk difference|3.6||||0.278|TWO_SIDED|95.0|-2.9|10.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||10.2|-2.9|0.278
71819135|NCT02065570|143141851|SUPERIORITY||Adjusted risk difference|3.7||||0.353|TWO_SIDED|95.0|-4.1|11.5||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.5|-4.1|0.353
71819136|NCT02065570|143141852|SUPERIORITY||Adjusted risk difference|8.9||||0.015|TWO_SIDED|95.0|1.8|16.0||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||16.0|1.8|0.015
71819137|NCT02065570|143141853|SUPERIORITY||Adjusted risk difference|3.4||||0.394|TWO_SIDED|95.0|-4.4|11.1||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|||11.1|-4.4|0.394
71819138|NCT02065570|143141854|SUPERIORITY||Adjusted risk difference|3.6||||0.349|TWO_SIDED|95.0|-4.0|11.2||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||11.2|-4.0|0.349
71819139|NCT02065570|143141855|SUPERIORITY||Adjusted risk difference|7.6||||0.054|TWO_SIDED|95.0|-0.1|15.3||Adjusted for previous infliximab use (or prior anti-TNF use for participants randomized under original protocol), hs-CRP at Baseline (\<10 mg/L, \>=10 mg/L) and Crohn's disease severity at Baseline (CDAI ≤ 300, CDAI \> 300).|Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose)|||15.3|-0.1|0.054
71819140|NCT02293837|143141893|SUPERIORITY|||||||0.277||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52; Primary imputation method used for missing Week 52 mAUC.||||0.277
71819141|NCT02293837|143141894|SUPERIORITY|||||||0.499||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.499
71819142|NCT02293837|143141894|SUPERIORITY|||||||0.267||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.267
71819143|NCT02293837|143141894|SUPERIORITY|||||||0.226||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.226
71819144|NCT02293837|143141894|SUPERIORITY|||||||0.758||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.758
71819145|NCT02293837|143141894|SUPERIORITY|||||||0.341||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.341
71819146|NCT02293837|143141894|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
71850742|NCT01159600|143215206|SUPERIORITY_OR_OTHER||Mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.74|-0.44||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.||-0.44|-0.74|<0.0001
71850743|NCT01366976|143215217|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Mixed Models Analysis|||We hypothesized that acetaminophen would reduce peak isofuran concentrations by 22 pg/mL (40% reduction from peak concentrations). If the true difference in the acetaminophen and placebo group means is 22 pg/mL (SD=30 pg/mL), we would need to study 30 experimental subjects and 30 control subjects to be able to reject the null hypothesis that the population means of the acetaminophen and placebo groups are equal with probability (power) 0.8.||||0.05
71901203|NCT04742907|143324484|SUPERIORITY||Cox Proportional Hazard|1.22||||0.055|TWO_SIDED|90.0|0.99|1.51||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to first toleration of clear liquids||1.51|0.99|0.055
71819147|NCT02293837|143141894|SUPERIORITY|||||||0.689||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 24||||0.689
71850744|NCT01366976|143215219|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Mixed Models Analysis|||||||0.12
71819148|NCT02293837|143141894|SUPERIORITY|||||||0.4||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.400
71819149|NCT02293837|143141894|SUPERIORITY|||||||0.969||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.969
71819150|NCT02293837|143141895|SUPERIORITY|||||||0.679||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.679
71819151|NCT02293837|143141895|SUPERIORITY|||||||0.373||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.373
71850745|NCT01690000|143215221|SUPERIORITY_OR_OTHER||||||<|0.05||||||The p-value was calculated|t-test, 2 sided|||The p-value was calculated||||<0.05
71850746|NCT04540952|143215241|SUPERIORITY|Power analysis indicated that with a sample size of 34 per arm, would provide 81% power to detect an effect size of 0.7 (0.7\*SD of fluid deficit) with a two-sided, two sample t test (a=0.05).|Mean Difference (Final Values)|11.3||||0.93|TWO_SIDED|95.0|-260.7|283.4|||t-test, 2 sided|||||283.4|-260.7|0.93
71901204|NCT04742907|143324484|SUPERIORITY||Cox Proportional Hazard|1.07||||0.306|TWO_SIDED|90.0|0.86|1.32||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.32|0.86|0.306
71901205|NCT04742907|143324484|SUPERIORITY||Cox Proportional Hazard|1.09||||0.243|TWO_SIDED|90.0|0.88|1.35||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to absence of distension and presence of bowel sounds and flatus||1.35|0.88|0.243
71901206|NCT04742907|143324485|SUPERIORITY||Cox Proportional Hazard|1.0||||0.489|TWO_SIDED|90.0|0.81|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.24|0.81|0.489
71901207|NCT04742907|143324485|SUPERIORITY||Cox Proportional Hazard|1.15||||0.138|TWO_SIDED|90.0|0.93|1.42||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to ready for discharge||1.42|0.93|0.138
71901208|NCT04742907|143324485|SUPERIORITY||Cox Proportional Hazard|1.01||||0.473|TWO_SIDED|90.0|0.82|1.24||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.24|0.82|0.473
71819152|NCT02293837|143141895|SUPERIORITY|||||||0.395||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was 2-hour C-peptide mAUC and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.395
71819153|NCT02293837|143141896|SUPERIORITY|||||||0.176||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.176
71819154|NCT02293837|143141896|SUPERIORITY|||||||0.285||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.285
71819155|NCT02293837|143141896|SUPERIORITY|||||||0.435||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52||||0.435
71819156|NCT02293837|143141896|SUPERIORITY|||||||0.931||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104||||0.931
71819157|NCT02293837|143141896|SUPERIORITY|||||||0.28||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 52. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.280
71819158|NCT02293837|143141896|SUPERIORITY|||||||0.985||||||P-value comes from an analysis of covariance with outcome variable of change in mAUC from screening and covariates of treatment, screening mAUC, and age.|ANCOVA|||Week 104. Only participants \>=12 years old had the 4-hour MMTT performed.||||0.985
71819159|NCT02293837|143141897|SUPERIORITY|||||||0.762||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.762
71819160|NCT02293837|143141897|SUPERIORITY|||||||0.64||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.640
71819161|NCT02293837|143141897|SUPERIORITY|||||||0.145||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.145
71901209|NCT04742907|143324485|SUPERIORITY||Cox Proportional Hazard|1.24||||0.045|TWO_SIDED|90.0|1.01|1.53||P-value is from the Wald Chi-Square statistic testing hypotheses of each dose of TU-100 compared with placebo: H0: HR = 1 vs. Ha: HR \> 1|Chi-squared||Hazard ratio and CIs are derived from a Cox proportional hazard model that includes main effects for treatment and surgical approach.|For Time to discharge order written||1.53|1.01|0.045
71901210|NCT04742907|143324486|SUPERIORITY|||||||0.923||||||P-value is from two-sample t-test comparing TU-100 15 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.923
71901211|NCT04742907|143324486|SUPERIORITY|||||||0.039||||||P-value is from two-sample t-test comparing TU-100 7.5 g/day treatment group versus placebo.|t-test, 2 sided|||||||0.039
71901212|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|0.79||||0.434|TWO_SIDED|95.0|0.44|1.42||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.42|0.44|0.434
71901213|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|0.9||||0.71|TWO_SIDED|95.0|0.51|1.59||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.59|0.51|0.710
71901214|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|1.23||||0.41|TWO_SIDED|95.0|0.75|2.02||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Chi-squared||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.02|0.75|0.410
71850747|NCT00949234|143215267|OTHER||||||<|0.05|||||||Chi-squared|||There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.||||<0.05
71850748|NCT00988429|143215326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058||95.0|||||ANCOVA|||||||0.058
71850749|NCT00988429|143215326|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0|||||ANCOVA|||||||0.004
71850750|NCT00988429|143215327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.068|||||||ANCOVA|||||||0.068
71901215|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|1.7||||0.037|TWO_SIDED|95.0|1.03|2.81||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||2.81|1.03|0.037
71901216|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|0.84||||0.579|TWO_SIDED|95.0|0.46|1.55||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||1.55|0.46|0.579
71901217|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|0.63||||0.167|TWO_SIDED|95.0|0.33|1.21||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic|||For Day 3||1.21|0.33|0.167
71901218|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|0.63||||0.4|TWO_SIDED|95.0|0.21|1.86||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.86|0.21|0.400
71850751|NCT00988429|143215327|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71850752|NCT01074229|143215328|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|Using Dunns test with Bonferroni conrrection for individual comparisons.||||||.05
71850753|NCT01074229|143215328|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|28.0||||0.05|TWO_SIDED|95.0|9.0|37.0|||Dunns test|Bonferonni correction||||37|9|.05
71850754|NCT01074229|143215328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0||||0.05|TWO_SIDED|95.0|14.0|42.0|||Dunns Test|Bonferroni correction||||42|14|.05
71850755|NCT01074229|143215329|SUPERIORITY_OR_OTHER|||||||0.05|||||||Kruskal-Wallis|With Dunns test and Bonferonni correction.||||||.05
71850756|NCT01074229|143215329|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003|TWO_SIDED|95.0|3.0|15.0|||Dunns test|||||15|3|0.003
71850757|NCT01074229|143215329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.0||||0.14|TWO_SIDED|95.0|-1.0|12.0|||Dunns test|||||12|-1|0.14
71850758|NCT02291861|143215330|SUPERIORITY||LSM difference|-1.9||||0.001|TWO_SIDED|95.0|-3.09|-0.79||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~The primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group."||-0.79|-3.09|0.001
71850759|NCT02291861|143215330|SUPERIORITY||LSM difference|-1.8||||0.003|TWO_SIDED|95.0|-3.0|-0.63||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence."||-0.63|-3.00|0.003
71882974|NCT00783094|143285056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.249|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.1|-0.4|0.249
71882975|NCT00783094|143285056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.022|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||-0.0|-0.6|0.022
71882976|NCT00783094|143285057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.904|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.3|-0.4|0.904
71882977|NCT00783094|143285057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.8|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.||||0.3|-0.4|0.800
71882978|NCT00783094|143285058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.147|TWO_SIDED|95.0|-1.5|0.2|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.|||0.2|-1.5|0.147
71882979|NCT00783094|143285058|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.4||0.094|TWO_SIDED|95.0|-1.6|0.1|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.|||0.1|-1.6|0.094
71882980|NCT00783094|143285061|SUPERIORITY_OR_OTHER|||||||0.342||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank-sum test|||||||0.342
71882981|NCT00783094|143285061|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||P-Value for systolic blood pressure.|Wilcoxin rank sum test|||||||0.127
71882982|NCT00783094|143285061|SUPERIORITY_OR_OTHER|||||||0.705||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.705
71882983|NCT00783094|143285061|SUPERIORITY_OR_OTHER|||||||0.173||95.0||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test|||||||0.173
71882984|NCT00783094|143285062|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Wilcoxin rank-sum test|||||||0.606
71819162|NCT02293837|143141897|SUPERIORITY|||||||0.033||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.033
71819163|NCT02293837|143141897|SUPERIORITY|||||||0.591||||||P-value comes from an analysis of covariance with outcome variable of change in avg insulin use per kg from baseline and covariates of treatment, baseline avg insulin use per kg, and age.|ANCOVA|||Week 52||||0.591
71819164|NCT02293837|143141897|SUPERIORITY|||||||0.81||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.810
71819165|NCT02293837|143141897|SUPERIORITY|||||||0.178||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 24||||0.178
71819166|NCT02293837|143141897|SUPERIORITY|||||||0.43||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 52||||0.430
71819167|NCT02293837|143141897|SUPERIORITY|||||||0.149||||||P-value comes from an analysis of covariance with outcome variable of change in average insulin use per kg from baseline and covariates of treatment, baseline average insulin use per kg, and age.|ANCOVA|||Week 104||||0.149
71819168|NCT02293837|143141898|SUPERIORITY|||||||0.103||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.103
71819169|NCT02293837|143141898|SUPERIORITY|||||||0.452||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.452
71819170|NCT02293837|143141898|SUPERIORITY|||||||0.091||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was average insulin use per kg and covariates were treatment, study week, age, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept and study week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.091
71819171|NCT02293837|143141899|SUPERIORITY|||||||0.154||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.154
71819172|NCT02293837|143141899|SUPERIORITY|||||||0.193||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.193
71819173|NCT02293837|143141899|SUPERIORITY|||||||0.397||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.397
71819174|NCT02293837|143141899|SUPERIORITY|||||||0.125||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.125
71819175|NCT02293837|143141899|SUPERIORITY|||||||0.705||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.705
71819176|NCT02293837|143141899|SUPERIORITY|||||||0.378||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.378
71819177|NCT02293837|143141899|SUPERIORITY|||||||0.035||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 24||||0.035
71819178|NCT02293837|143141899|SUPERIORITY|||||||0.262||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 52||||0.262
71819179|NCT02293837|143141899|SUPERIORITY|||||||0.338||||||P-value comes from an analysis of covariance with outcome variable of change in HbA1c from baseline and covariates of treatment, baseline HbA1c, and age.|ANCOVA|||Week 104||||0.338
71819180|NCT02293837|143141900|SUPERIORITY|||||||0.493||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.493
71850760|NCT02291861|143215330|SUPERIORITY||LSM difference|-0.7||||0.217|TWO_SIDED|95.0|-1.84|0.42||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence."||0.42|-1.84|0.217
71882985|NCT00783094|143285062|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Wilcoxin rank-sum test|||||||0.149
71882986|NCT00783094|143285063|SUPERIORITY_OR_OTHER|||||||0.428||95.0|||||Wilcoxin rank-sum test|||||||0.428
71882987|NCT00783094|143285063|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||Wilcoxin rank-sum test|||||||0.426
71882988|NCT00783094|143285064|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxin rank-sum|||||||0.060
71882989|NCT00783094|143285064|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Wilcoxin rank-sum|||||||0.212
71901219|NCT04742907|143324488|SUPERIORITY||Odds Ratio (OR)|0.28||||0.083|TWO_SIDED|95.0|0.07|1.18|||Regression, Logistic||Responder status is analyzed using logistic regression with GIR response as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||1.18|0.07|0.083
71901220|NCT04742907|143324489|SUPERIORITY||Odds Ratio (OR)|1.33||||0.621|TWO_SIDED|95.0|0.43|4.14||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||4.14|0.43|0.621
71901221|NCT04742907|143324489|SUPERIORITY||Odds Ratio (OR)|1.03||||0.962|TWO_SIDED|95.0|0.31|3.46||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||POI-related Morbidity status is analyzed using logistic regression with POI-related morbidity as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|||3.46|0.31|0.962
71901222|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|1.16||||0.604|TWO_SIDED|95.0|0.66|2.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||2.05|0.66|0.604
71901223|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|1.12||||0.693|TWO_SIDED|95.0|0.63|1.99||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.99|0.63|0.693
71901224|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|1.8||||0.122|TWO_SIDED|95.0|0.85|3.78||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||3.78|0.85|0.122
71901225|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|0.78||||0.518|TWO_SIDED|95.0|0.36|1.67||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.67|0.36|0.518
71850761|NCT02291861|143215331|SUPERIORITY||Odds Ratio (OR)|2.11||||0.059|TWO_SIDED|95.0|0.96|4.645|||Cochran-Mantel-Haenszel|The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence."||4.645|0.960|0.059
71901226|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|1.45||||0.528|TWO_SIDED|95.0|0.46|4.53||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.53|0.46|0.528
71901227|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|1.27||||0.689|TWO_SIDED|95.0|0.4|4.07||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||4.07|0.40|0.689
71901228|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|0.68||||0.653|TWO_SIDED|95.0|0.12|3.7||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.70|0.12|0.653
71901229|NCT04742907|143324491|SUPERIORITY||Odds Ratio (OR)|1.85||||0.452|TWO_SIDED|95.0|0.37|9.25||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Nausea status is analyzed using logistic regression with Subject-reported (eDiary) - Nausea as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||9.25|0.37|0.452
71901230|NCT04742907|143324492|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.359|TWO_SIDED|95.0|-1.8|0.6|||Mixed Models Analysis|||For Day 1, least square (LS) mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.6|-1.8|0.359
71901231|NCT04742907|143324492|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.907|TWO_SIDED|95.0|-1.3|1.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.2|-1.3|0.907
71901232|NCT04742907|143324492|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.856|TWO_SIDED|95.0|-1.3|1.6|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.6|-1.3|0.856
71901233|NCT04742907|143324492|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.18|TWO_SIDED|95.0|-2.7|0.5|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.5|-2.7|0.180
71901234|NCT04742907|143324492|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.814|TWO_SIDED|95.0|-1.9|2.4|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.4|-1.9|0.814
71901235|NCT04742907|143324492|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.409|TWO_SIDED|95.0|-3.2|1.3|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Nausea as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||1.3|-3.2|0.409
71901236|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.8||||0.43|TWO_SIDED|95.0|0.46|1.4||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.40|0.46|0.430
71850762|NCT02291861|143215331|SUPERIORITY||Odds Ratio (OR)|2.71||||0.014|TWO_SIDED|95.0|1.211|6.052|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence."||6.052|1.211|0.014
71850763|NCT02291861|143215331|SUPERIORITY||Odds Ratio (OR)|1.15||||0.734|TWO_SIDED|95.0|0.509|2.61|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence."||2.610|0.509|0.734
71850764|NCT02291861|143215332|SUPERIORITY||LSM difference|-3.6||||0.207|TWO_SIDED|95.0|-9.18|2.0||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.00|-9.18|0.207
71901237|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|1.1||||0.739|TWO_SIDED|95.0|0.62|1.96||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 1||1.96|0.62|0.739
71901238|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.54||||0.13|TWO_SIDED|95.0|0.25|1.2||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.20|0.25|0.130
71901239|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.52||||0.099|TWO_SIDED|95.0|0.24|1.13||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 2||1.13|0.24|0.099
71901240|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.78||||0.686|TWO_SIDED|95.0|0.23|2.63||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.63|0.23|0.686
71819181|NCT02293837|143141900|SUPERIORITY|||||||0.659||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.659
71901241|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.75||||0.644|TWO_SIDED|95.0|0.22|2.56||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 3||2.56|0.22|0.644
71819182|NCT02293837|143141900|SUPERIORITY|||||||0.407||||||P-value is for group difference in time trends from a longitudinal mixed effects model. Response variable was HbA1c and covariates were treatment, study week, spline week (at week 4), age, treatment\*spline week, treatment\*study week, age\*study week.|Longitudinal mixed model|Random within-subject effects for intercept, study week, and spline week were included assuming an unstructured covariance matrix.||Screening to Week 104||||0.407
71819183|NCT02293837|143141901|SUPERIORITY|||||||0.634||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.634
71819184|NCT02293837|143141901|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
71850765|NCT02291861|143215332|SUPERIORITY||LSM difference|-3.1||||0.281|TWO_SIDED|95.0|-8.86|2.59||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||2.59|-8.86|0.281
71850766|NCT02291861|143215332|SUPERIORITY||LSM difference|1.3||||0.627|TWO_SIDED|95.0|-4.1|6.79||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo|||6.79|-4.10|0.627
71850767|NCT02291861|143215333|SUPERIORITY||Odds Ratio (OR)|1.51||||0.296|TWO_SIDED|95.0|0.694|3.285||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.285|0.694|0.296
71850768|NCT02291861|143215333|SUPERIORITY||Odds Ratio (OR)|1.82||||0.134|TWO_SIDED|95.0|0.826|3.994||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.994|0.826|0.134
71819185|NCT02293837|143141901|SUPERIORITY|||||||0.329||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.329
71819186|NCT02293837|143141901|SUPERIORITY|||||||1||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||1.000
71850769|NCT02291861|143215333|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.302|1.563||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||1.563|0.302|0.372
71850770|NCT02291861|143215334|SUPERIORITY||Odds Ratio (OR)|3.8||||0.007|TWO_SIDED|95.0|1.395|10.359||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.359|1.395|0.007
71850771|NCT02291861|143215334|SUPERIORITY||Odds Ratio (OR)|3.96||||0.005|TWO_SIDED|95.0|1.46|10.716||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||10.716|1.460|0.005
71819187|NCT02293837|143141901|SUPERIORITY|||||||0.847||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 52||||0.847
71850772|NCT02291861|143215334|SUPERIORITY||Odds Ratio (OR)|1.13||||0.829|TWO_SIDED|95.0|0.383|3.316||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|||3.316|0.383|0.829
71850773|NCT02291861|143215335|SUPERIORITY||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.44|-9.52||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-9.52|-33.44|<0.001
71850774|NCT02291861|143215335|SUPERIORITY||Mean Difference (Final Values)|-20.2||||0.001|TWO_SIDED|95.0|-32.57|-7.92||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||-7.92|-32.57|0.001
71850775|NCT02291861|143215335|SUPERIORITY||Mean Difference (Final Values)|-8.4||||0.16|TWO_SIDED|95.0|-20.15|3.34||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|||3.34|-20.15|0.160
71901242|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.54||||0.498|TWO_SIDED|95.0|0.09|3.18||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||3.18|0.09|0.498
71819188|NCT02293837|143141901|SUPERIORITY|||||||0.858||||||P-value is from comparing the number of participants with a hypoglycemic event between the two treatment groups using Fisher's exact test.|Fisher Exact|||Baseline to Week 104/End of Study||||0.858
71819189|NCT02293837|143141902|SUPERIORITY|||||||0.296||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.296
71819190|NCT02293837|143141902|SUPERIORITY|||||||0.145||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.145
71819191|NCT02293837|143141902|SUPERIORITY|||||||0.027||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.027
71819192|NCT02293837|143141903|SUPERIORITY|||||||0.547||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.547
71819193|NCT02293837|143141903|SUPERIORITY|||||||0.551||||||P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.|Fisher Exact|||Treatment start to Week 52||||0.551
71819194|NCT04779242|143141904|OTHER|Difference was observed difference in early clinical success rate between the omadacycline and moxifloxacin groups|Percentage difference|1.9|||||TWO_SIDED|95.0|-3.0|6.8|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification.|||6.8|-3.0|
71819195|NCT04779242|143141905|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups.|Percentage difference|-1.7|||||TWO_SIDED|95.0|-6.9|3.4|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||3.4|-6.9|
71819196|NCT04779242|143141906|OTHER|Difference was observed difference in overall clinical success rate at PTE between the omadacycline and moxifloxacin groups|Percentage difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.0|||||95% CI is constructed based on the Miettinen and Nurminen method without stratification|||2.0|-5.7|
71819197|NCT01757067|143141907|OTHER|The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||||||||||||||||The previously stated primary and secondary endpoints cannot be calculated as the study was halted prematurely due to lack of enrollment. Only the reported EF data was collected. This makes further statistical analyses impossible.|||
71819198|NCT02942004|143141923|SUPERIORITY||Least Square (LS) Mean Difference|-5.5|STANDARD_ERROR_OF_MEAN|1.664||0.0013|TWO_SIDED|95.0|-8.8|-2.2|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.20|-8.80|0.0013
71819199|NCT02942004|143141923|SUPERIORITY||LS mean difference|-3.68|STANDARD_ERROR_OF_MEAN|1.622||0.0252|TWO_SIDED|95.0|-6.9|-0.47|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.47|-6.90|0.0252
71819200|NCT02942004|143141924|SUPERIORITY||LS mean difference|-5.63|STANDARD_ERROR_OF_MEAN|1.936||0.0044|TWO_SIDED|95.0|-9.46|-1.79|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.79|-9.46|0.0044
71819201|NCT02942004|143141924|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|1.899||0.0481|TWO_SIDED|95.0|-7.56|-0.03|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-7.56|0.0481
71850776|NCT03845517|143215360|SUPERIORITY||Risk Difference (RD)|-7.5||||0.8076|TWO_SIDED|95.0|-24.5|9.5||One sided p-value.|Cochran-Mantel-Haenszel|||||9.5|-24.5|0.8076
71850777|NCT03845517|143215360|SUPERIORITY||Risk Difference (RD)|5.2||||0.2189|TWO_SIDED|95.0|-7.9|18.3||One sided p-value.|Cochran-Mantel-Haenszel|||||18.3|-7.9|0.2189
71850778|NCT03845517|143215360|SUPERIORITY||Risk Difference (RD)|1.7||||0.401|TWO_SIDED|95.0|-11.8|15.3||One sided p-value.|Cochran-Mantel-Haenszel|||||15.3|-11.8|0.4010
71850779|NCT03845517|143215361|SUPERIORITY||Risk Difference (RD)|-2.1||||0.595|TWO_SIDED|95.0|-19.1|14.9||One sided p-value.|Cochran-Mantel-Haenszel|||||14.9|-19.1|0.5950
71850780|NCT03845517|143215361|SUPERIORITY||Risk Difference (RD)|8.6||||0.1125|TWO_SIDED|95.0|-5.3|22.6||One sided p-value.|Cochran-Mantel-Haenszel|||||22.6|-5.3|0.1125
71850781|NCT03845517|143215361|SUPERIORITY||Risk Difference (RD)|9.6||||0.0891|TWO_SIDED|95.0|-4.4|23.6||One sided p-value.|Cochran-Mantel-Haenszel|||||23.6|-4.4|0.0891
71850782|NCT00257309|143215383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.21|TWO_SIDED|95.0|0.38|1.23||Unadjusted analysis|Chi-squared|||||1.23|0.38|0.21
71901243|NCT04742907|143324493|SUPERIORITY||Odds Ratio (OR)|0.71||||0.7|TWO_SIDED|95.0|0.12|4.05||p value is assessing the null hypothesis that the odds ratio is equal to 1.|Regression, Logistic||Subject-reported (eDiary) - Abdominal Bloating status is analyzed using logistic regression with Subject-reported (eDiary) - Abdominal Bloating as the dependent variable; treatment and surgical approach (open, laparoscopic) as covariates.|For Day 4||4.05|0.12|0.700
71901244|NCT04742907|143324494|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.9|0.8|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-0.9|0.919
71901245|NCT04742907|143324494|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.016|TWO_SIDED|95.0|-1.8|-0.2|||Mixed Models Analysis|||For Day 1, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||-0.2|-1.8|0.016
71901246|NCT04742907|143324494|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.064|TWO_SIDED|95.0|-0.1|2.0|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.0|-0.1|0.064
71901247|NCT04742907|143324494|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.683|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||For Day 2, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-1.3|0.683
71901248|NCT04742907|143324494|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.462|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 15 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||2.1|-1.0|0.462
71901249|NCT04742907|143324494|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.343|TWO_SIDED|95.0|-2.3|0.8|||Mixed Models Analysis|||For Day 3, LS mean difference between placebo and TU-100 7.5 g/day. Mixed Model Repeated Measures approach was used to assess the bothersomeness of Abdominal Bloating as the dependent variable and treatment group, surgical approach and treatment group by visit as covariates. An unstructured covariance structure is used to model the within-subject errors, shared across treatments.||0.8|-2.3|0.343
71901250|NCT00210158|143324511|SUPERIORITY||Mean Difference (Final Values)|9.7||||0.5|TWO_SIDED|95.0|-23.4|42.8|||t-test, 2 sided|||T-test for a difference of means, assuming independant samples and unequal variances||42.8|-23.4|0.5
71901251|NCT01005719|143324519|SUPERIORITY_OR_OTHER|||||||0.0242||95.0||||p-value for 10-15 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0242
71901252|NCT01005719|143324519|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value for 15-20 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0270
71901253|NCT01005719|143324519|SUPERIORITY_OR_OTHER|||||||0.0067||95.0||||p-value for 20-25 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values \<= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)|||||||0.0067
71901254|NCT01005719|143324520|SUPERIORITY_OR_OTHER|||||||0.0465||95.0||||p-value for 10-15 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0465
71901255|NCT01005719|143324520|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||p-value for 15-20 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||0.0012
71901256|NCT01005719|143324520|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for 20-25 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)|||||||<0.0001
71901257|NCT01005719|143324521|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
71901258|NCT01005719|143324521|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
71901259|NCT01005719|143324521|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
71901260|NCT01005719|143324521|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)|||||||<0.05
71901261|NCT05187013|143324612|SUPERIORITY||Mean Difference (Net)|-7.16|STANDARD_ERROR_OF_MEAN|2.72||0.006|TWO_SIDED|95.0|-12.59|-1.73|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final SBP, i.e., Final SBP - Baseline SBP \>= 0 Alternative Hypothesis: Final SBP - Baseline SBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -7.16 and 21.40, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 83.16%||-1.73|-12.59|0.006
71901262|NCT05187013|143324612|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|1.32||0.056|TWO_SIDED|95.0|-4.79|0.49|||t-test, 1 sided|||Null Hypothesis: No improvement between baseline and final DBP, i.e., Final DBP - Baseline DBP \>= 0 Alternative Hypothesis: Final DBP - Baseline DBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -2.15 and 10.49, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 51.48%||0.49|-4.79|0.056
71819202|NCT02942004|143141925|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.951||0.9591|TWO_SIDED|95.0|-1.83|1.93|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.93|-1.83|0.9591
71819203|NCT02942004|143141925|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.917||0.8677|TWO_SIDED|95.0|-1.66|1.97|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.97|-1.66|0.8677
71819204|NCT02942004|143141925|SUPERIORITY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|1.208||0.0827|TWO_SIDED|95.0|-4.51|0.28|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-4.51|0.0827
71850783|NCT03386344|143215389|SUPERIORITY||Difference in Least Squares (LS) Means|-0.45|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.649|-0.25|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.250|-0.649|<0.0001
71850784|NCT03386344|143215389|SUPERIORITY||Difference in LS Means|-0.43|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.634|-0.235|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline HbA1c as a covariate.||-0.235|-0.634|<0.0001
71901263|NCT05187013|143324612|EQUIVALENCE|The margin was considered to be 0.|Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|4.13||0.87|TWO_SIDED|95.0|-8.76|7.42|||ANCOVA|Adjusted for baseline SBP and follow-up time|The parameter was defined as the change in SBP for the general health education arm - the change in SBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in SBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||7.42|-8.76|0.87
71901264|NCT05187013|143324612|EQUIVALENCE|The margin was taken to be 0|Mean Difference (Net)|0.98|STANDARD_ERROR_OF_MEAN|2.04||0.63|TWO_SIDED|95.0|-3.02|4.98|||ANCOVA|Adjusted for baseline DBP and follow-up time|The parameter was defined as the change in DBP for the general health education arm - the change in DBP for the HTN specific education arm adjusted for follow-up time and baseline SBP|"Null hypothesis: No difference between the change in DBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level."||4.98|-3.02|0.63
71901265|NCT05187013|143324613|EQUIVALENCE|The margin is taken to be 0|Odds Ratio, log|0.89|STANDARD_ERROR_OF_MEAN|0.61||0.14|TWO_SIDED|95.0|-0.26|2.29|||Regression, Logistic|A mixed effect model with study arm as a fixed effect and subject-specific random effect.|For OR: the general education arm was taken as the baseline (denominator)|Null hypothesis: There is no difference in medicine adherence between the two groups||2.29|-0.26|0.14
71901266|NCT05187013|143324614|EQUIVALENCE|The margin was taken to be 0.|Odds Ratio, log|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.32|TWO_SIDED|95.0|-0.58|0.19|||Regression, Logistic|Binomial regression for appointment attended/appointment scheduled.|The baseline (denominator) was taken to be the general education arm.|Null hypothesis: No difference in appointment adherence between the study arms||0.19|-0.58|0.32
71901267|NCT03015610|143324625|SUPERIORITY|||||||0.8716|||||||Wilcoxon (Mann-Whitney)|||||||0.8716
71901268|NCT03015610|143324626|SUPERIORITY|||||||0.2471|||||||Wilcoxon (Mann-Whitney)|||||||0.2471
71901269|NCT03015610|143324627|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71901270|NCT03015610|143324628|SUPERIORITY|||||||0.2765|||||||Wilcoxon (Mann-Whitney)|||||||0.2765
71901271|NCT03015610|143324629|SUPERIORITY||Risk Ratio (RR)|2.32||||0.191|TWO_SIDED|95.0|0.66|8.2|||Negative binomial regression|||||8.20|0.66|0.191
71901272|NCT03015610|143324630|SUPERIORITY||Risk Ratio (RR)|0.53||||0.0435|TWO_SIDED|95.0|0.29|0.98|||Negative binomial regression|||||0.98|0.29|0.0435
71901273|NCT03015610|143324631|SUPERIORITY|||||||0.3808|||||||Wilcoxon (Mann-Whitney)|||||||0.3808
71901274|NCT01193348|143324677|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|63.6|||||TWO_SIDED|95.0|40.7|82.8||||||||82.8|40.7|
71901275|NCT01193348|143324678|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|81.8|||||TWO_SIDED|95.0|59.7|94.8||||||||94.8|59.7|
71901276|NCT01193348|143324679|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.0|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
71901277|NCT01193348|143324680|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
71901278|NCT01193348|143324681|SUPERIORITY_OR_OTHER||LS mean change from baseline|204.96|||<|0.0001|TWO_SIDED|95.0|164.44|245.49|||ANOVA|||||245.49|164.44|<0.0001
71901279|NCT01193348|143324682|SUPERIORITY_OR_OTHER||Percent of Complete TMA Response|68.2|||||TWO_SIDED|95.0|45.1|86.1||||||||86.1|45.1|
71901280|NCT01193348|143324683|SUPERIORITY_OR_OTHER||Percent of Complete Hematologic Response|90.9|||||TWO_SIDED|95.0|70.8|98.9||||||||98.9|70.8|
71819205|NCT02942004|143141925|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.172||0.7968|TWO_SIDED|95.0|-2.62|2.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.02|-2.62|0.7968
71819206|NCT02942004|143141925|SUPERIORITY||LS mean difference|-2.04|STANDARD_ERROR_OF_MEAN|1.336||0.1292|TWO_SIDED|95.0|-4.69|0.61|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.61|-4.69|0.1292
71819207|NCT02942004|143141925|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|1.299||0.7801|TWO_SIDED|95.0|-2.94|2.21|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.21|-2.94|0.7801
71819208|NCT02942004|143141925|SUPERIORITY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|1.436||0.384|TWO_SIDED|95.0|-4.1|1.59|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.59|-4.10|0.3840
71819209|NCT02942004|143141925|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.395||0.6097|TWO_SIDED|0.71|-2.05|3.48|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.48|-2.05|0.6097
71819210|NCT02942004|143141925|SUPERIORITY||LS mean difference|-4.28|STANDARD_ERROR_OF_MEAN|1.622||0.0094|TWO_SIDED|95.0|-7.5|-1.07|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.07|-7.50|0.0094
71819211|NCT02942004|143141925|SUPERIORITY||LS mean difference|-2.32|STANDARD_ERROR_OF_MEAN|1.577||0.144|TWO_SIDED|95.0|-5.45|0.8|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.80|-5.45|0.1440
71819212|NCT02942004|143141925|SUPERIORITY||LS mean difference|-5.12|STANDARD_ERROR_OF_MEAN|1.62||0.002|TWO_SIDED|95.0|-8.33|-1.91|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.91|-8.33|0.0020
71819213|NCT02942004|143141925|SUPERIORITY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|1.572||0.3906|TWO_SIDED|95.0|-4.47|1.76|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.76|-4.47|0.3906
71850785|NCT03386344|143215390|SUPERIORITY||Difference in LS Means|-0.24|STANDARD_ERROR_OF_MEAN|0.423||0.5707|TWO_SIDED|95.0|-1.07|0.59|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.590|-1.070|0.5707
71850786|NCT03386344|143215390|SUPERIORITY||Difference in LS Means|-0.15|STANDARD_ERROR_OF_MEAN|0.419||0.7247|TWO_SIDED|95.0|-0.969|0.674|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||0.674|-0.969|0.7247
71850787|NCT03386344|143215391|SUPERIORITY||Difference in LS Means|0.14|STANDARD_ERROR_OF_MEAN|0.308||0.6454|TWO_SIDED|95.0|-0.462|0.745|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.745|-0.462|0.6454
71850788|NCT03386344|143215391|SUPERIORITY||Difference in LS Means|0.19|STANDARD_ERROR_OF_MEAN|0.308||0.5289|TWO_SIDED|95.0|-0.41|0.798|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline lumbar spine as a covariate.||0.798|-0.410|0.5289
71819214|NCT02942004|143141925|SUPERIORITY||LS mean difference|-4.49|STANDARD_ERROR_OF_MEAN|1.735||0.011|TWO_SIDED|95.0|-7.93|-1.05|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.05|-7.93|0.0110
71850789|NCT03386344|143215392|SUPERIORITY||Difference in LS Means|0.75|STANDARD_ERROR_OF_MEAN|0.462||0.105|TWO_SIDED|95.0|-0.157|1.654|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.654|-0.157|0.1050
71850790|NCT03386344|143215392|SUPERIORITY||Difference in LS Means|0.32|STANDARD_ERROR_OF_MEAN|0.46||0.4804|TWO_SIDED|95.0|-0.577|1.226|||ANCOVA|||Percent change from baseline to Week 26 was analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline BMD as a covariate.||1.226|-0.577|0.4804
71901281|NCT01193348|143324684|SUPERIORITY_OR_OTHER||Percent of Platelet Count Normalization|95.5|||||TWO_SIDED|95.0|77.2|99.9||||||||99.9|77.2|
71901282|NCT01193348|143324685|SUPERIORITY_OR_OTHER||Percent of eGFR Improvement|86.4|||||TWO_SIDED|95.0|65.1|97.1||||||||97.1|65.1|
71901283|NCT01193348|143324686|SUPERIORITY_OR_OTHER||LS mean change from baseline|165.43|||<|0.0001|TWO_SIDED|95.0|98.43|232.43|||ANOVA|||||232.43|98.43|<0.0001
71901284|NCT03259334|143324699|SUPERIORITY|||||||0.617|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.617
71901285|NCT03259334|143324699|SUPERIORITY|||||||0.018|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.018
71901286|NCT03259334|143324700|SUPERIORITY|||||||0.253|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.253
71850791|NCT03386344|143215393|SUPERIORITY||Difference in LS Means|-1.91|STANDARD_ERROR_OF_MEAN|0.336|<|0.0001|TWO_SIDED|95.0|-2.568|-1.252|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.252|-2.568|<0.0001
71901287|NCT03259334|143324700|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.002
71901288|NCT03259334|143324701|SUPERIORITY|||||||0.764|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.764
71901289|NCT03259334|143324701|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.080
71901290|NCT03259334|143324702|SUPERIORITY|||||||0.44|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.440
71901291|NCT03259334|143324702|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.002
71901292|NCT03259334|143324703|SUPERIORITY|||||||0.286|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline||||||0.286
71901293|NCT03259334|143324703|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|P-value was based on Cochran-Mantel-Haenszel chi-square test stratified by actual status of prior anti-TNF treatment and glucocorticoid at baseline.||||||0.005
71901294|NCT01725152|143324757|SUPERIORITY|||||||0.4475|||||||Linear mixed-effect|||Null hypothesis of no treatment difference in CGI-I will be assessed using a linear mixed-effects model for repeated measures, accounting for treatment (ganaxolone versus placebo) and period at a significant level of 0.05. A sample size of 30 participants in each arm/group was planned in the study will have 90% power to detect a modest effect size of 0.6 at level 0.05 in CGI-I. With a possible dropout rate of 15%, the power for testing the effect size becomes 84%.||||0.4475
71901295|NCT00372190|143324763|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71901296|NCT03521154|143324783|SUPERIORITY||Hazard Ratio (HR)|0.16|||<|0.001|TWO_SIDED|95.0|0.1|0.24|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.24|0.10|<0.001
71901297|NCT03521154|143324784|SUPERIORITY||Hazard Ratio (HR)|0.17|||||TWO_SIDED|95.0|0.1|0.29|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in Ex19Del positive patients||0.29|0.10|
71901298|NCT03521154|143324784|SUPERIORITY||Hazard Ratio (HR)|0.32||||||95.0|0.19|0.56|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|PFS in L858R positive patients||0.56|0.19|
71901299|NCT03521154|143324785|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.15|0.34|||Cox proportional hazard model||A hazard ratio \< 1 favours osimertinib|Negative at screening||0.34|0.15|
71901300|NCT03521154|143324786|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.09|<0.001
71901301|NCT03521154|143324788|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.53|TWO_SIDED|95.0|0.42|1.56|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.56|0.42|0.530
71901302|NCT03521154|143324789|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.54|5.08|||Regression, Logistic||An odds ratio \> 1 favours osimertinib|||5.08|1.54|<0.001
71901303|NCT03521154|143324791|SUPERIORITY||Odds Ratio (OR)|2.06||||0.069|TWO_SIDED|95.0|0.94|4.47|||Regression, Logistic||An odds ratio \> 1 favours osimertinib.|||4.47|0.94|0.069
71901304|NCT03521154|143324794|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.11|0.38|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.38|0.11|<0.001
71901305|NCT03521154|143324795|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.14|0.32|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.32|0.14|<0.001
71901306|NCT03521154|143324796|SUPERIORITY||Hazard Ratio (HR)|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.21|0.08|<0.001
71901307|NCT03521154|143324797|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.022|TWO_SIDED|95.0|0.28|0.91|||Log Rank||A hazard ratio \< 1 favours osimertinib|||0.91|0.28|0.022
71901308|NCT03521154|143324798|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.088|TWO_SIDED|95.0|0.35|1.08|||Log Rank||A hazard ratio \< 1 favours osimertinib|||1.08|0.35|0.088
71819215|NCT02942004|143141925|SUPERIORITY||LS mean difference|-3.33|STANDARD_ERROR_OF_MEAN|1.69||0.0511|TWO_SIDED|95.0|-6.68|0.02|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-6.68|0.0511
71819216|NCT02942004|143141925|SUPERIORITY||LS mean difference|-5.02|STANDARD_ERROR_OF_MEAN|1.738||0.0046|TWO_SIDED|95.0|-8.47|-1.58|||MMRM|||Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-1.58|-8.47|0.0046
71901309|NCT00365716|143324813|SUPERIORITY_OR_OTHER||Vaccine Efficacy|89.5||||||95.0|70.7|97.3|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."|||97.3|70.7|
71901310|NCT06150573|143324814|SUPERIORITY||Adjusted Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.498||0.9141|TWO_SIDED|95.0|-1.04|0.93|||ANOVA|||||0.93|-1.04|0.9141
71901311|NCT06150573|143324815|SUPERIORITY||Adjusted Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.494||0.4583|TWO_SIDED|95.0|-0.61|1.34|||ANOVA|||||1.34|-0.61|0.4583
71901312|NCT06150573|143324816|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0042|TWO_SIDED|95.0|-0.3|-0.06|||ANOVA|||Week 12||-0.06|-0.30|0.0042
71901313|NCT06150573|143324816|SUPERIORITY||Adjusted Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.074|<|0.0001|TWO_SIDED|95.0|-0.46|-0.17|||ANOVA|||Week 24||-0.17|-0.46|<0.0001
71901314|NCT06150573|143324817|SUPERIORITY||Adjusted Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.016||0.2478|TWO_SIDED|95.0|-0.05|0.01|||ANOVA|||Mean Gingival MLSI, Week 12||0.01|-0.05|0.2478
71901315|NCT06150573|143324817|SUPERIORITY||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.0957|TWO_SIDED|95.0|-0.07|0.01|||ANOVA|||Mean Gingival MLSI, Week 24||0.01|-0.07|0.0957
71901316|NCT06150573|143324817|SUPERIORITY||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.122||0.0063|TWO_SIDED|95.0|-0.58|-0.1|||ANOVA|||Mean Interproximal MLSI, Week 12||-0.10|-0.58|0.0063
71901317|NCT06150573|143324817|SUPERIORITY||Adjusted Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.147|<|0.0001|TWO_SIDED|95.0|-0.89|-0.31|||ANOVA|||Mean Interproximal MLSI, Week 24||-0.31|-0.89|<0.0001
71901318|NCT06150573|143324817|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.1536|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|||Mean Body MLSI, Week 12||0.01|-0.03|0.1536
71901319|NCT06150573|143324817|SUPERIORITY||Adjusted Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.006||0.1166|TWO_SIDED|95.0|-0.02|0.0|||ANOVA|||Mean Body MLSI, Week 24||0.00|-0.02|0.1166
71901320|NCT06150573|143324818|SUPERIORITY||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-0.21|-0.07|||ANOVA|||Week 12||-0.07|-0.21|<0.0001
71901321|NCT06150573|143324818|SUPERIORITY||Adjusted Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|-0.25|-0.1|||ANOVA|||Week 24||-0.10|-0.25|<0.0001
71901322|NCT06150573|143324819|SUPERIORITY||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.033||0.04|TWO_SIDED|95.0|-0.13|0.0|||ANOVA|||Week 12||-0.00|-0.13|0.0400
71901323|NCT06150573|143324819|SUPERIORITY||Adjusted Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.037||0.001|TWO_SIDED|95.0|-0.2|-0.05|||ANOVA|||Week 24||-0.05|-0.20|0.0010
71901324|NCT00069095|143324820|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.05|||||TWO_SIDED|97.5|0.94|1.18||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.18|0.94|
71901325|NCT00069095|143324821|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.22|||||TWO_SIDED|97.5|1.05|1.42||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.42|1.05|
71901326|NCT00069095|143324822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|97.5|0.58|0.83|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.83|0.58|<0.0001
71901327|NCT00069095|143324823|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in the 'on-treatment analysis', thus leading to reduced power. No formal statistical testing was therefore applied.|Hazard Ratio (HR)|1.24|||||TWO_SIDED|97.5|1.07|1.44||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.44|1.07|
71901328|NCT00069095|143324824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|97.5|0.52|0.75|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.75|0.52|<0.0001
71901329|NCT00069095|143324825|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|97.5|0.92|1.15||||||Equivalence of treatment arm A ('XELOX') to treatment arm B ('FOLFOX-4') was tested via the following hypotheses - H0: HRA/B \>/= 1.23 versus H1: HRA/B \< 1.23. HRA/B denotes the hazard of disease progression or death under treatment A ('XELOX') divided by the hazard of disease progression or death under treatment B ('FOLFOX-4').||1.15|0.92|
71901330|NCT00069095|143324826|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0015|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0015
71901331|NCT00069095|143324827|NON_INFERIORITY_OR_EQUIVALENCE|This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis \[Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)\] were therefore applied to OS as well.|Hazard Ratio (HR)|0.97|||||TWO_SIDED|97.5|0.84|1.14||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.14|0.84|
71901332|NCT00069095|143324828|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1921|TWO_SIDED|97.5|0.72|1.09|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented together with the 97.5% confidence interval.||1.09|0.72|0.1921
71901333|NCT00069095|143324829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0023|TWO_SIDED|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.95|0.72|0.0023
71901334|NCT00069095|143324830|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.89|||||TWO_SIDED|97.5|0.72|1.09||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66, where OR denotes Odds ratio.||1.09|0.72|
71901335|NCT00069095|143324831|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.3091|TWO_SIDED|97.5|0.71|1.14|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%.||1.14|0.71|0.3091
71901336|NCT00069095|143324832|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.94|||||TWO_SIDED|97.5|0.76|1.16||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \</= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) \> 0.66||1.16|0.76|
71901337|NCT00069095|143324833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9887|TWO_SIDED|97.5|0.78|1.28|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) \</= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) \> 1.0. The test used a two-sided significance level of 2.5%||1.28|0.78|0.9887
71901338|NCT00069095|143324834|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|1.08|||||TWO_SIDED|97.5|0.97|1.2||||||General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.20|0.97|
71901339|NCT00069095|143324834|NON_INFERIORITY_OR_EQUIVALENCE|Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|97.5|0.98|1.23||||||On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.23|0.98|
71901340|NCT00069095|143324835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.003|TWO_SIDED|97.5|0.74|0.96|||Log Rank|||General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.96|0.74|0.0030
71819217|NCT02942004|143141925|SUPERIORITY||LS mean difference|-2.53|STANDARD_ERROR_OF_MEAN|1.694||0.1389|TWO_SIDED|95.0|-5.88|0.83|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.83|-5.88|0.1389
71819218|NCT02942004|143141925|SUPERIORITY||LS mean difference|-4.07|STANDARD_ERROR_OF_MEAN|1.837||0.0288|TWO_SIDED|95.0|-7.71|-0.43|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.43|-7.71|0.0288
71819219|NCT02942004|143141925|SUPERIORITY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.797||0.3799|TWO_SIDED|95.0|-5.15|1.98|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.98|-5.15|0.3799
71819220|NCT02942004|143141925|SUPERIORITY||LS mean difference|-2.92|STANDARD_ERROR_OF_MEAN|2.139||0.1747|TWO_SIDED|95.0|-7.16|1.32|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.32|-7.16|0.1747
71819221|NCT02942004|143141925|SUPERIORITY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|2.08||0.631|TWO_SIDED|95.0|-5.13|3.12|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.12|-5.13|0.6310
71819222|NCT02942004|143141925|SUPERIORITY||LS mean difference|-4.92|STANDARD_ERROR_OF_MEAN|2.045||0.0178|TWO_SIDED|95.0|-8.98|-0.87|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.87|-8.98|0.0178
71819223|NCT02942004|143141925|SUPERIORITY||LS mean difference|-3.51|STANDARD_ERROR_OF_MEAN|1.976||0.0786|TWO_SIDED|95.0|-7.43|0.41|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.41|-7.43|0.0786
71850792|NCT03386344|143215393|SUPERIORITY||Difference in LS Means|-1.7|STANDARD_ERROR_OF_MEAN|0.335|<|0.0001|TWO_SIDED|95.0|-2.36|-1.046|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline body weight as a covariate.||-1.046|-2.360|<0.0001
71850793|NCT03386344|143215394|SUPERIORITY||Difference in LS Means|-18.891|STANDARD_ERROR_OF_MEAN|4.5766|<|0.0001|TWO_SIDED|95.0|-27.8605|-9.9205|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-9.9205|-27.8605|<0.0001
71850794|NCT03386344|143215394|SUPERIORITY||Difference in LS Means|-21.333|STANDARD_ERROR_OF_MEAN|4.5902|<|0.0001|TWO_SIDED|95.0|-30.3294|-12.336|||ANCOVA|||The change from baseline to Week 26 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, baseline fasting plasma glucose as a covariate.||-12.3360|-30.3294|<0.0001
71850795|NCT03386344|143215395|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|1.48||0.5864|TWO_SIDED|95.0|-3.705|2.095|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||2.095|-3.705|0.5864
71850796|NCT03386344|143215395|SUPERIORITY||Difference in LS Means|-1.16|STANDARD_ERROR_OF_MEAN|1.478||0.4315|TWO_SIDED|95.0|-4.058|1.734|||ANCOVA|||The change from baseline to Week 12 was analyzed using an ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of sex (male, female), and country as fixed effects, and baseline SBP as a covariate.||1.734|-4.058|0.4315
71850797|NCT03386344|143215396|SUPERIORITY||Percentage Difference|10.5||||0.0172|TWO_SIDED|95.0|1.78|19.23|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||19.23|1.78|0.0172
71901341|NCT00069095|143324835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.0004|TWO_SIDED|97.5|0.7|0.92|||Log Rank|||On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||0.92|0.70|0.0004
71901342|NCT00069095|143324838|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was performed for duration of overall response.|Hazard Ratio (HR)|1.02|||||TWO_SIDED|97.5|0.86|1.22||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)||1.22|0.86|
71850798|NCT03386344|143215396|SUPERIORITY||Percentage Difference|12.0||||0.0076|TWO_SIDED|95.0|3.23|20.86|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups from randomization strata of HbA1c (≤8.5, \>8.5%) at screening and randomization strata of sex (male, female) using Cochran-Mantel-Haenszel weights.||20.86|3.23|0.0076
71850799|NCT03449979|143215401|SUPERIORITY|||||||0.0852|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 3.119||Interaction in the effect of tACS on left frontal alpha oscillation in the depressed group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.0852
71850800|NCT03449979|143215401|SUPERIORITY|||||||0.6676|||||||ANOVA|degrees of freedom = (1,39); F-statistic = 0.187||Interaction in the effect of tACS on left frontal alpha oscillation in the healthy group. Two-way interaction of within-participant factor of before/after tACS and between-participant factor of alpha-tACS/placebo.||||0.6676
71850801|NCT03449979|143215401|SUPERIORITY|||||||0.929||||||degrees of freedom = (1,41); F-statistic = 0.008|ANOVA|||Main effect of alpha-tACS on session (before and after) on left frontal alpha oscillations across both groups (healthy and patient).||||0.929
71850802|NCT03449979|143215401|SUPERIORITY|||||||0.195|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = -0.08789||Difference in alpha oscillations after versus before in the depressed cohort (one-tailed Student's t-test) with the hypothesis to decrease pathologically elevate left frontal alpha oscillations||||0.1950
71850803|NCT03449979|143215401|SUPERIORITY|||||||0.8603|||||||t-test, 1 sided|degrees of freedom = 20; t-statistic = 1.1117||Difference in alpha oscillations after versus before in the healthy cohort (one-tailed Student's t-test) run as a control analysis||||0.8603
71850804|NCT00700999|143215412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92|STANDARD_DEVIATION|0.9||0.001|TWO_SIDED|95.0|-1.38|-0.45|||t-test, 2 sided|||||-0.45|-1.38|.001
71850805|NCT00700999|143215412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_DEVIATION|1.78||0.869|TWO_SIDED|95.0|-0.84|0.99|||t-test, 2 sided|||||.99|-.84|.869
71850806|NCT02991118|143215434|SUPERIORITY||Difference in LS mean|-17.42|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-20.951|-13.896|||ANCOVA|||||-13.896|-20.951|<0.001
71850807|NCT02991118|143215435|SUPERIORITY||Difference in LS mean|-14.77|STANDARD_ERROR_OF_MEAN|2.418|<|0.001|TWO_SIDED|95.0|-19.504|-10.027|||ANCOVA|||||-10.027|-19.504|<0.001
71850808|NCT02991118|143215436|SUPERIORITY||Difference in LS mean|-13.03|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-16.27|-9.794|||ANCOVA|||||-9.794|-16.270|<0.001
71901343|NCT00069095|143324839|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0307|TWO_SIDED|97.5|0.66|1.01|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||1.01|0.66|0.0307
71901344|NCT00069095|143324840|NON_INFERIORITY_OR_EQUIVALENCE|No formal statistical testing was done.|Hazard Ratio (HR)|0.35|||||TWO_SIDED|97.5|0.09|1.39||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).||1.39|0.09|
71850809|NCT02991118|143215437|SUPERIORITY||Difference in LS mean|-11.2|STANDARD_ERROR_OF_MEAN|1.224|<|0.001|TWO_SIDED|95.0|-13.599|-8.801|||ANCOVA|||||-8.801|-13.599|<0.001
71850810|NCT02991118|143215438|SUPERIORITY||Difference in LS mean|-13.02|STANDARD_ERROR_OF_MEAN|1.587|<|0.001|TWO_SIDED|95.0|-16.13|-9.907|||ANCOVA|||||-9.907|-16.130|<0.001
71850811|NCT02991118|143215439|SUPERIORITY||Location shift|-8.733|||<|0.039|TWO_SIDED|95.0|-17.238|-0.434|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-0.434|-17.238|<0.039
71850812|NCT02991118|143215442|SUPERIORITY||Difference in LS mean|4.89|STANDARD_ERROR_OF_MEAN|3.258||0.134|TWO_SIDED|95.0|-1.504|11.292|||ANCOVA|||||11.292|-1.504|0.134
71850813|NCT02991118|143215443|SUPERIORITY||Difference in LS mean|-6.13|STANDARD_ERROR_OF_MEAN|1.139|<|0.001|TWO_SIDED|95.0|-8.369|-3.896|||ANCOVA|||||-3.896|-8.369|<0.001
71850814|NCT02991118|143215444|SUPERIORITY||Difference in LS mean|-12.27|STANDARD_ERROR_OF_MEAN|2.314|<|0.001|TWO_SIDED|95.0|-16.813|-7.722|||ANCOVA|||||-7.722|-16.813|<0.001
71850815|NCT02991118|143215445|SUPERIORITY||Difference in LS mean|-12.63|STANDARD_ERROR_OF_MEAN|2.01|<|0.001|TWO_SIDED|95.0|-16.58|-8.682|||ANCOVA|||||-8.682|-16.580|<0.001
71850816|NCT02991118|143215446|SUPERIORITY||Difference in LS mean|-9.92|STANDARD_ERROR_OF_MEAN|1.976|<|0.001|TWO_SIDED|95.0|-13.803|-6.037|||ANCOVA|||||-6.037|-13.803|<0.001
71850817|NCT02991118|143215447|SUPERIORITY||Difference in LS mean|-10.77|STANDARD_ERROR_OF_MEAN|1.489|<|0.001|TWO_SIDED|95.0|-13.698|-7.848|||ANCOVA|||||-7.848|-13.698|<0.001
71850818|NCT02991118|143215448|SUPERIORITY||Difference in LS mean|-8.36|STANDARD_ERROR_OF_MEAN|1.458|<|0.001|TWO_SIDED|95.0|-11.223|-5.493|||ANCOVA|||||-5.493|-11.223|<0.001
71850819|NCT02991118|143215449|SUPERIORITY||Difference in LS mean|-13.0|STANDARD_ERROR_OF_MEAN|2.451|<|0.001|TWO_SIDED|95.0|-17.829|-8.175|||ANCOVA|||||-8.175|-17.829|<0.001
71850820|NCT02991118|143215450|SUPERIORITY||Difference in LS mean|-9.58|STANDARD_ERROR_OF_MEAN|1.796|<|0.001|TWO_SIDED|95.0|-13.107|-6.047|||ANCOVA|||||-6.047|-13.107|<0.001
71850821|NCT02991118|143215451|SUPERIORITY||Location shift|-21.278|||<|0.001|TWO_SIDED|95.0|-32.25|-10.034|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-10.034|-32.250|<0.001
71850822|NCT02991118|143215452|SUPERIORITY||Location shift|-7.587||||0.102|TWO_SIDED|95.0|-16.978|1.653|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||1.653|-16.978|0.102
71850823|NCT02991118|143215453|SUPERIORITY||Difference in LS mean|-15.07|STANDARD_ERROR_OF_MEAN|2.641|<|0.001|TWO_SIDED|95.0|-20.26|-9.878|||ANCOVA|||||-9.878|-20.260|<0.001
71850824|NCT00595959|143215454|SUPERIORITY_OR_OTHER|||||||0.001||||||No adjustments|t-test, 1 sided|||Comparing to an expected value of 20% reduction from initial to post-laser||||0.001
71850825|NCT02077374|143215470|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.0||||0.0195|TWO_SIDED|95.0|-30.7|-2.5|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo||-2.5|-30.7|0.0195
71819224|NCT02942004|143141926|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0052|TWO_SIDED|95.0|1.7|17.4|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.4|1.7|0.0052
71819225|NCT02942004|143141926|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0493|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.9|1.0|0.0493
71819226|NCT02942004|143141926|SUPERIORITY||Odds Ratio (OR)|2.5||||0.0572|TWO_SIDED|95.0|1.0|6.5|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.5|1.0|0.0572
71819227|NCT02942004|143141926|SUPERIORITY||Odds Ratio (OR)|1.2||||0.6768|TWO_SIDED|95.0|0.5|3.0|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.0|0.5|0.6768
71819228|NCT02942004|143141926|SUPERIORITY||Odds Ratio (OR)|5.4||||0.0035|TWO_SIDED|95.0|1.7|16.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||16.8|1.7|0.0035
71819229|NCT02942004|143141926|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0347|TWO_SIDED|95.0|1.1|7.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.8|1.1|0.0347
71819230|NCT02942004|143141927|SUPERIORITY||Odds Ratio (OR)|6.0||||0.0011|TWO_SIDED|95.0|2.1|17.8|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||17.8|2.1|0.0011
71819231|NCT02942004|143141927|SUPERIORITY||Odds Ratio (OR)|2.6||||0.0828|TWO_SIDED|95.0|0.9|7.6|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||7.6|0.9|0.0828
71819232|NCT02942004|143141927|SUPERIORITY||Odds Ratio (OR)|1.2||||0.7749|TWO_SIDED|95.0|0.4|3.1|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||3.1|0.4|0.7749
71819233|NCT02942004|143141927|SUPERIORITY||Odds Ratio (OR)|0.6||||0.3401|TWO_SIDED|95.0|0.2|1.7|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||1.7|0.2|0.3401
71819234|NCT02942004|143141927|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1052|TWO_SIDED|95.0|0.8|6.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||6.0|0.8|0.1052
71819235|NCT02942004|143141927|SUPERIORITY||Odds Ratio (OR)|1.6||||0.3507|TWO_SIDED|95.0|0.6|4.2|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.||4.2|0.6|0.3507
71819236|NCT02942004|143141928|SUPERIORITY||LS mean difference|-12.07|STANDARD_ERROR_OF_MEAN|4.294||0.0058|TWO_SIDED|95.0|-20.58|-3.56|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-3.56|-20.58|0.0058
71850826|NCT02077374|143215472|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.8||||0.8724|TWO_SIDED|95.0|-14.5|11.2|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo||11.2|-14.5|0.8724
71901345|NCT00069095|143324841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.8207|TWO_SIDED|97.5|0.2|7.05|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone \[HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)\] was presented.||7.05|0.20|0.8207
71901346|NCT00830037|143324852|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.35||||0.79|TWO_SIDED|95.0|-2.9|2.3||a = 0.05|Mixed Models Analysis|Wald test||The analysis of the primary outcome was intention to treat, if the patient received at least one dose of the randomized drug (which was the case for each subject). A linear mixed model was used with GFR as the outcome variable. Fixed effects were indicator variables for time (treated as a continuous variable), treatment, and their interaction. Random effects were subject and time with unstructured covariance; statistical inference was made using the maximum likelihood estimator.||2.3|-2.9|0.79
71901347|NCT00830037|143324853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.035||||0.83|TWO_SIDED|95.0|-0.294|0.365||a = 0.05|Mixed Models Analysis|Wald test||The secondary analysis examined the mean change from baseline proteinuria (log protein to creatinine ratio) at 2 years. The between-groups difference in mean change from baseline is reported with a 95% confidence interval and the p-value from the Wald test.||0.365|-0.294|0.83
71901348|NCT00752609|143324854|SUPERIORITY_OR_OTHER||Mean change from baseline|-0.42|||||TWO_SIDED|95.0|-0.65|-0.19|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||-0.19|-0.65|
71901349|NCT00752609|143324854|SUPERIORITY_OR_OTHER||Mean change from baseline|0.49|||||TWO_SIDED|95.0|0.26|0.71|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.71|0.26|
71901350|NCT02439281|143324875|OTHER|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
71819237|NCT02942004|143141928|SUPERIORITY||LS mean difference|-5.89|STANDARD_ERROR_OF_MEAN|4.188||0.1622|TWO_SIDED|95.0|-14.19|2.41|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||2.41|-14.19|0.1622
71819238|NCT02942004|143141928|SUPERIORITY||LS mean difference|-9.09|STANDARD_ERROR_OF_MEAN|4.51||0.0462|TWO_SIDED|95.0|-18.02|-0.16|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-0.16|-18.02|0.0462
71819239|NCT02942004|143141928|SUPERIORITY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|4.41||0.6124|TWO_SIDED|95.0|-10.97|6.49|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||6.49|-10.97|0.6124
71819240|NCT02942004|143141928|SUPERIORITY||LS mean difference|-11.68|STANDARD_ERROR_OF_MEAN|4.556||0.0116|TWO_SIDED|95.0|-20.71|-2.66|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||-2.66|-20.71|0.0116
71901351|NCT02439281|143324876|OTHER|||||||0.8914|||||||Wilcoxon (Mann-Whitney)|||||||0.8914
71901352|NCT02439281|143324879|OTHER|||||||0.9531|||||||Wilcoxon (Mann-Whitney)|||||||0.9531
71901353|NCT02439281|143324880|OTHER|||||||0.778|||||||Wilcoxon (Mann-Whitney)|||||||0.7780
71901354|NCT02439281|143324881|OTHER|||||||0.5692|||||||Wilcoxon (Mann-Whitney)|||||||0.5692
71901355|NCT00358917|143324882|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (once daily \[QD\] minus twice daily \[BID\], based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|Diff. in Percentage of Subj. Responding|3.5||||0.413||95.0|-4.5|11.5|||normal approx. to binomial distribution|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||11.5|-4.5|0.413
71901356|NCT00358917|143324883|SUPERIORITY_OR_OTHER||Diff. in Percentage of Subj. Responding|3.8||||0.389||95.0|-4.3|11.9|||normal approx. to binomial distribution|||||11.9|-4.3|0.389
71901357|NCT00358917|143324884|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANOVA|||||||0.281
71901358|NCT00358917|143324886|SUPERIORITY_OR_OTHER|||||||0.222||95.0|||||Fisher Exact|||||||0.222
71901359|NCT01254396|143324914|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|41.35|||||TWO_SIDED|90.0|32.4|52.76||||||Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||52.76|32.40|
71901360|NCT01254396|143324916|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|93.42|||||TWO_SIDED|90.0|80.23|108.78||||||Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||108.78|80.23|
71901361|NCT01254396|143324917|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|87.66|||||TWO_SIDED|90.0|77.62|98.99||||||Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.||98.99|77.62|
71679555|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0427|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0427
71679556|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0209|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0209
71819241|NCT02942004|143141928|SUPERIORITY||LS mean difference|-8.26|STANDARD_ERROR_OF_MEAN|4.464||0.0667|TWO_SIDED|95.0|-17.1|0.58|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.||0.58|-17.10|0.0667
71819242|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191||0.9681|TWO_SIDED|95.0|-0.39|0.37|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.39|0.9681
71819243|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.185||0.6337|TWO_SIDED|95.0|-0.28|0.46|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.28|0.6337
71819244|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.238||0.469|TWO_SIDED|95.0|-0.64|0.3|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.64|0.4690
71819245|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.232||0.9905|TWO_SIDED|95.0|-0.46|0.46|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.46|0.9905
71901362|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% confidential interval (CI) on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|13.16|||||TWO_SIDED|95.0|8.99|19.28|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|Geometric mean ratio (GMR) of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||19.28|8.99|
71901363|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.88|||||TWO_SIDED|95.0|4.32|8.01|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||8.01|4.32|
71679557|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3401|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3401
71901364|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.98|||||TWO_SIDED|95.0|12.07|26.78|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||26.78|12.07|
71819246|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.24||0.3984|TWO_SIDED|95.0|-0.68|0.27|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.68|0.3984
71819247|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.234||0.7042|TWO_SIDED|95.0|-0.37|0.55|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.55|-0.37|0.7042
71819248|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.247||0.4941|TWO_SIDED|95.0|-0.66|0.32|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.66|0.4941
71819249|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.24||0.4572|TWO_SIDED|95.0|-0.3|0.65|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.65|-0.30|0.4572
71819250|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.236||0.9866|TWO_SIDED|95.0|-0.47|0.46|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.47|0.9866
71819251|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.229||0.749|TWO_SIDED|95.0|-0.53|0.38|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.53|0.7490
71819252|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.247||0.0235|TWO_SIDED|95.0|-1.06|-0.08|||MMRM|||Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-1.06|0.0235
71819253|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.239||0.9286|TWO_SIDED|95.0|-0.5|0.45|||MMRM|||Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.50|0.9286
71819254|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.251||0.0544|TWO_SIDED|95.0|-0.99|0.01|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.99|0.0544
71850827|NCT02077374|143215473|SUPERIORITY_OR_OTHER||Median Difference (Net)|-145.0||||0.1149|TWO_SIDED|95.0|-336.0|55.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo||55|-336|0.1149
71850828|NCT02077374|143215474|SUPERIORITY_OR_OTHER||Median Difference (Net)|-250.0||||0.1365|TWO_SIDED|95.0|-590.0|63.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo||63|-590|0.1365
71850829|NCT02077374|143215475|SUPERIORITY_OR_OTHER||Median Difference (Net)|-327.0||||0.0471|TWO_SIDED|95.0|-628.0|-7.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo||-7|-628|0.0471
71850830|NCT03032965|143215487|SUPERIORITY|||||||0.83|||||||Log Rank|Kaplan Meier log rank||||||.83
71850831|NCT03032965|143215488|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||.35
71850832|NCT03032965|143215490|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71850833|NCT00636168|143215496|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0013|TWO_SIDED|95.0|0.64|0.9|||Log Rank|stratified 2-sided log-rank test||The hazard ratio, and its 95 % confidence interval was estimated using a Cox proportional hazards model, stratified by stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as indicated at randomization, with treatment as the single covariate.. The analysis was performed after 528 RFS events per IRC were reported. Two-sided, 95% confidence intervals for median RFS were computed by the Brookmeyer and Crowley method using log-log transformation.||0.90|0.64|0.0013
71901365|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.42|||||TWO_SIDED|95.0|1.9|3.08|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||3.08|1.90|
71901366|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.35|||||TWO_SIDED|95.0|4.68|8.61|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||8.61|4.68|
71901367|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.64|||||TWO_SIDED|95.0|4.92|8.97|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||8.97|4.92|
71901368|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.42|||||TWO_SIDED|95.0|6.91|12.83|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||12.83|6.91|
71901369|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.89|||||TWO_SIDED|95.0|2.96|5.1|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||5.10|2.96|
71901370|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|62.13|||||TWO_SIDED|95.0|40.16|96.12|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||96.12|40.16|
71901371|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|16.37|||||TWO_SIDED|95.0|11.22|23.89|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||23.89|11.22|
71901372|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.25|||||TWO_SIDED|95.0|3.22|5.62|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||5.62|3.22|
71901373|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.73|||||TWO_SIDED|95.0|6.24|12.21|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||12.21|6.24|
71901374|NCT05372575|143324926|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.33|||||TWO_SIDED|95.0|6.15|11.29|||||GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||11.29|6.15|
71901375|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMR (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|Geometric Mean Ratio (GMR)|4.78|||||TWO_SIDED|95.0|2.32|9.86|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 1||9.86|2.32|
71901376|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.06|||||TWO_SIDED|95.0|4.72|17.39|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 3||17.39|4.72|
71901377|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.37|||||TWO_SIDED|95.0|6.25|33.05|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 4||33.05|6.25|
71901378|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.03|||||TWO_SIDED|95.0|8.84|36.8|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 5||36.80|8.84|
71850834|NCT00636168|143215499|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0024|TWO_SIDED|95.8|0.64|0.92|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.8% confidence interval are based on a stratified Cox proportional hazards model||0.92|0.64|0.0024
71850835|NCT00636168|143215502|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0013|TWO_SIDED|95.1|0.58|0.88|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with \>= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model||0.88|0.58|0.0013
71901379|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|33.88|||||TWO_SIDED|95.0|14.33|80.13|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6A||80.13|14.33|
71819255|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.244||0.2903|TWO_SIDED|95.0|-0.74|0.22|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.74|0.2903
71819256|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.244||0.0044|TWO_SIDED|95.0|-1.19|-0.23|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.19|0.0044
71819257|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.238||0.1339|TWO_SIDED|95.0|-0.83|0.11|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.83|0.1339
71819258|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.234||0.0149|TWO_SIDED|95.0|-1.04|-0.11|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-1.04|0.0149
71819259|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.228||0.3213|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3213
71819260|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.246||0.0703|TWO_SIDED|95.0|-0.94|0.04|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.94|0.0703
71819261|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.8152|TWO_SIDED|95.0|-0.53|0.42|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.53|0.8152
71819262|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.301||0.0805|TWO_SIDED|95.0|-1.13|0.07|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-1.13|0.0805
71819263|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.291||0.6964|TWO_SIDED|95.0|-0.69|0.46|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.69|0.6964
71679558|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0031
71679559|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0283
71679560|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6233|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6233
71679561|NCT02612610|142877084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
71679562|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4925|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4925
71679563|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9007|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9007
71679564|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
71819264|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.304||0.2998|TWO_SIDED|95.0|-0.92|0.29|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.92|0.2998
71819265|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.291||0.3448|TWO_SIDED|95.0|-0.85|0.3|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.85|0.3448
71819266|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.248||0.0089|TWO_SIDED|95.0|-1.15|-0.17|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.15|0.0089
71850836|NCT02707952|143215511|NON_INFERIORITY|The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of -10%, then arm A was considered non-inferior to arm B.|Rate Difference|-0.9|||||TWO_SIDED|95.0|-2.8|0.9|||||95% CI was calculated using the normal approximation to the binomial distribution.|||0.9|-2.8|
71901380|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|14.05|||||TWO_SIDED|95.0|6.07|32.52|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 6B||32.52|6.07|
71901381|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.99|||||TWO_SIDED|95.0|7.85|36.76|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 7F||36.76|7.85|
71901382|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|19.31|||||TWO_SIDED|95.0|9.13|40.84|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 9V||40.84|9.13|
71901383|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.46|||||TWO_SIDED|95.0|4.74|23.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 14||23.10|4.74|
71901384|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.13|||||TWO_SIDED|95.0|6.0|24.51|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 18C||24.51|6.00|
71901385|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.65|||||TWO_SIDED|95.0|10.94|51.1|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19A||51.10|10.94|
71901386|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.62|||||TWO_SIDED|95.0|8.65|35.93|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 19F||35.93|8.65|
71679565|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3440
71679566|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9876|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9876
71679567|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
71850837|NCT02006641|143215516|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.51||1|TWO_SIDED|95.0|-1.1|0.92||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.92|-1.10|1.000
71850838|NCT02006641|143215516|SUPERIORITY||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.52||0.2223|TWO_SIDED|95.0|-0.38|1.65||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.65|-0.38|0.2223
71882990|NCT04852848|143285086|EQUIVALENCE|In our original power calculation, we expected to randomly assign 200 individuals to the Connect2Test (n = 100) and control conditions (n = 100). Power calculations were conducted using G\*Power assuming a two-tailed test with alpha = .05, power = .80, and an estimated COVID-19 testing rate in the Connect2Test condition of 20%. With these assumptions, the minimum detectable effect size (odds ratio) is 2.46, which corresponds to a moderate Cohen's d (0.49).|Odds Ratio (OR)|1.18||||0.6298|TWO_SIDED|95.0|0.61|2.27|||Chi-squared||The control condition was the reference category (Connect2Test intervention = 1, Control = 0).|||2.27|0.61|.6298
71901387|NCT05372575|143324927|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|44.46|||||TWO_SIDED|95.0|19.11|103.43|||||GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)|GMR of 13vPnC Cohort/Non-13vPnC Cohort for Serotype: 23F||103.43|19.11|
71679568|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5968|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5968
71819267|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.244||0.0772|TWO_SIDED|95.0|-0.92|0.05|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.92|0.0772
71819268|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.191||0.6809|TWO_SIDED|95.0|-0.46|0.3|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.46|0.6809
71819269|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.185||0.7297|TWO_SIDED|95.0|-0.3|0.43|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.30|0.7297
71819270|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.226||0.0626|TWO_SIDED|95.0|-0.87|0.02|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.87|0.0626
71819271|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5196|TWO_SIDED|95.0|-0.58|0.29|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.58|0.5196
71819272|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.234||0.0772|TWO_SIDED|95.0|-0.88|0.05|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.88|0.0772
71819273|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.228||0.661|TWO_SIDED|95.0|-0.55|0.35|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.55|0.6610
71819274|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.239||0.4007|TWO_SIDED|95.0|-0.67|0.27|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.67|0.4007
71819275|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.232||0.2292|TWO_SIDED|95.0|-0.18|0.74|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.74|-0.18|0.2292
71819276|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.234||0.054|TWO_SIDED|95.0|-0.92|0.01|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.92|0.0540
71819277|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.227||0.959|TWO_SIDED|95.0|-0.44|0.46|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.44|0.9590
71819278|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.218||0.1048|TWO_SIDED|95.0|-0.79|0.08|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.79|0.1048
71850839|NCT02006641|143215517|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.65||1|TWO_SIDED|95.0|-1.11|1.46||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.46|-1.11|1.000
71850840|NCT02006641|143215517|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.66||1|TWO_SIDED|95.0|-1.27|1.33||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||1.33|-1.27|1.000
71819279|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8979|TWO_SIDED|95.0|-0.44|0.39|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.44|0.8979
71819280|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.219||0.0819|TWO_SIDED|95.0|-0.82|0.05|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.82|0.0819
71819281|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.213||0.1099|TWO_SIDED|95.0|-0.77|0.08|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.77|0.1099
71819282|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0373|TWO_SIDED|95.0|-0.88|-0.03|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.88|0.0373
71819283|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.209||0.0577|TWO_SIDED|95.0|-0.81|0.01|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.81|0.0577
71819284|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2023|TWO_SIDED|95.0|-0.69|0.15|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.69|0.2023
71819285|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.204||0.4444|TWO_SIDED|95.0|-0.56|0.25|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.56|0.4444
71819286|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.3645|TWO_SIDED|95.0|-0.64|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.64|0.3645
71819287|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.214||0.4035|TWO_SIDED|95.0|-0.6|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.60|0.4035
71819288|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.232||0.4877|TWO_SIDED|95.0|-0.62|0.3|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.62|0.4877
71819289|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.226||0.3134|TWO_SIDED|95.0|-0.68|0.22|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.68|0.3134
71819290|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.24||0.0922|TWO_SIDED|95.0|-0.89|0.07|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.89|0.0922
71819291|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.23||0.0761|TWO_SIDED|95.0|-0.87|0.04|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.87|0.0761
71819292|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3275|TWO_SIDED|95.0|-0.64|0.22|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.64|0.3275
71819293|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.213||0.3041|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3041
71819294|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.146||0.045|TWO_SIDED|95.0|-0.59|-0.01|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.59|0.0450
71819295|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.143||0.5351|TWO_SIDED|95.0|-0.19|0.37|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.19|0.5351
71819296|NCT02942004|143141929|SUPERIORITY||LS men difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0525|TWO_SIDED|95.0|-0.56|0.0|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.56|0.0525
71819297|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.139||0.7932|TWO_SIDED|95.0|-0.24|0.31|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.24|0.7932
71819298|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.128||0.13|TWO_SIDED|95.0|-0.45|0.06|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.45|0.1300
71882991|NCT00517595|143285091|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.02
71882992|NCT00517595|143285092|SUPERIORITY_OR_OTHER|||||||0.0041||95.0|||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).||||0.0041
71901388|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|Geometric Mean Ratio (GMR)|0.48|||||TWO_SIDED|95.0|0.16|1.42|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||1.42|0.16|
71901389|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|1.98|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||1.98|0.27|
71901390|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.21|2.19|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.19|0.21|
71901391|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.36|1.86|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||1.86|0.36|
71901392|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.25|1.89|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.89|0.25|
71819299|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.125||0.1631|TWO_SIDED|95.0|-0.07|0.42|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.07|0.1631
71901393|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.27|2.07|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||2.07|0.27|
71901394|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.42|||||TWO_SIDED|95.0|0.16|1.09|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||1.09|0.16|
71901395|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.35|1.81|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.81|0.35|
71819300|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.129||0.8215|TWO_SIDED|95.0|-0.23|0.29|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.23|0.8215
71901396|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.66|||||TWO_SIDED|95.0|0.2|2.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||2.24|0.20|
71901397|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.6|||||TWO_SIDED|95.0|0.22|1.65|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||1.65|0.22|
71901398|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.55|||||TWO_SIDED|95.0|0.61|3.93|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||3.93|0.61|
71901399|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.8|||||TWO_SIDED|95.0|0.65|4.99|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||4.99|0.65|
71819301|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.126||0.038|TWO_SIDED|95.0|0.01|0.51|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.51|0.01|0.0380
71819302|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.124||0.507|TWO_SIDED|95.0|-0.33|0.16|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.33|0.5070
71819303|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.12||0.1094|TWO_SIDED|95.0|-0.04|0.43|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.04|0.1094
71819304|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.099||0.3112|TWO_SIDED|95.0|-0.3|0.1|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.30|0.3112
71819305|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.096||0.1345|TWO_SIDED|95.0|-0.05|0.33|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.05|0.1345
71819306|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.091||0.5148|TWO_SIDED|95.0|-0.24|0.12|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.24|0.5148
71819307|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.088||0.3863|TWO_SIDED|95.0|-0.25|0.1|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.25|0.3863
71850841|NCT02006641|143215518|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.08||1|TWO_SIDED|95.0|-0.23|0.1||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.10|-0.23|1.000
71882993|NCT00876187|143285161|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.21||0.113|TWO_SIDED|95.0|-0.74|0.08|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on least squares (LS) mean. Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.08|-0.74|0.113
71819308|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.094||0.0209|TWO_SIDED|95.0|-0.41|-0.03|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.41|0.0209
71819309|NCT02942004|143141929|SUPERIORITY||LS men difference|-0.17|STANDARD_ERROR_OF_MEAN|0.092||0.0616|TWO_SIDED|95.0|-0.35|0.01|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.35|0.0616
71882994|NCT00876187|143285161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.19|-0.42|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.42|-1.19|<0.001
71882995|NCT00876187|143285161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.31|-0.54|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.54|-1.31|<0.001
71850842|NCT02006641|143215518|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.09||1|TWO_SIDED|95.0|-0.12|0.21||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.||0.21|-0.12|1.000
71850843|NCT01047709|143215538|SUPERIORITY_OR_OTHER||relative % difference|19.5|STANDARD_DEVIATION|23.0||0.011|TWO_SIDED|95.0|4.9|31.9|||GEE||SD of control night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
71850844|NCT01047709|143215538|SUPERIORITY_OR_OTHER||Relative % difference|19.5|STANDARD_DEVIATION|16.0||0.011||95.0|4.9|31.9|||GEE||SD of intervention night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.||31.9|4.9|0.011
71850845|NCT01697956|143215544|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of BDP nasal aerosol versus placebo was greater than 0.80.|ratio of BDP nasal aerosol to placebo|0.91|||||TWO_SIDED|95.0|0.81|1.03||||||The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups.||1.03|0.81|
71850846|NCT03293238|143215565|SUPERIORITY|||||||0.527|||||||ANOVA|||||||0.527
71819310|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.099||0.186|TWO_SIDED|95.0|-0.33|0.06|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.33|0.1860
71819311|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.095||0.773|TWO_SIDED|95.0|-0.22|0.16|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.22|0.7730
71819312|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1593|TWO_SIDED|95.0|-0.44|0.07|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.44|0.1593
71819313|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6371|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6371
71819314|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.124||0.5655|TWO_SIDED|95.0|-0.32|0.18|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.32|0.5655
71819315|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.121||0.3326|TWO_SIDED|95.0|-0.12|0.36|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.12|0.3326
71850847|NCT03293238|143215566|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
71850848|NCT01313663|143215610|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|90.0|0.32|2.65|||||HRs were estimated using the Pike estimator. The hazard ratio and p-value from the stratified log-rank test were adjusted for disease stage at Baseline only, due to sparse data.|||2.65|0.32|
71850849|NCT01020487|143215640|SUPERIORITY_OR_OTHER||Difference|27.8||||0.045|TWO_SIDED|95.0|7.5|52.8|||Fisher Exact|||Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.||52.8|7.5|0.045
71850850|NCT01020487|143215641|SUPERIORITY_OR_OTHER|||||||0.128|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.128
71850851|NCT01020487|143215642|SUPERIORITY_OR_OTHER||Differenbce|-72.4|||<|0.001|TWO_SIDED|95.0|-108.05|-36.75|||Mixed Models Analysis|||Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-36.75|-108.05|< 0.001
71679569|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8726|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.8726
71679570|NCT02612610|142877085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4092|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4092
71679571|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0781|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0781
71679572|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7098|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.7098
71679573|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0068|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0068
71679574|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1284|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1284
71679575|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.267|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2670
71679576|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0013
71679577|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4343|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4343
71679578|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5384|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5384
71679579|NCT02612610|142877086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0822|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0822
71819316|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.201||0.3577|TWO_SIDED|95.0|-0.59|0.22|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.59|0.3577
71819317|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.1646|TWO_SIDED|95.0|-0.66|0.11|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.66|0.1646
71679580|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
71679581|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0223|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0223
71679582|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
71679583|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0165
71679584|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6255|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.6255
71679585|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0085|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0085
71679586|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0722|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0722
71679587|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3577|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3577
71679588|NCT02612610|142877087|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0006
71679589|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3845|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3845
71679590|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1177|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1177
71679591|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0236|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0236
71850852|NCT01020487|143215642|SUPERIORITY_OR_OTHER||Difference|-62.55||||0.006|TWO_SIDED|95.0|-105.6|-19.49|||Mixed Models Analysis|||Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-19.49|-105.60|0.006
71901400|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.47|||||TWO_SIDED|95.0|0.17|1.31|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.31|0.17|
71679592|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0192|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0192
71679593|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3301|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3301
71679594|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0008
71679595|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0285|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0285
71679596|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3856|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3856
71679597|NCT02612610|142877088|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0001
71679598|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2441|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2441
71679599|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5055|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.5055
71679600|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.1602
71679601|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2721|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.2721
71679602|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9763|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9763
71679603|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.0993
71819318|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.118||0.0545|TWO_SIDED|95.0|-0.46|0.0|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.46|0.0545
71850853|NCT01020487|143215642|SUPERIORITY_OR_OTHER||Difference|-68.43||||0.032|TWO_SIDED|95.0|-130.39|-6.47|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-6.47|-130.39|0.032
71901401|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.31|1.38|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||1.38|0.31|
71901402|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.7|||||TWO_SIDED|95.0|0.4|1.24|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||1.24|0.40|
71901403|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.33|1.59|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||1.59|0.33|
71901404|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.8|||||TWO_SIDED|95.0|0.52|1.25|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||1.25|0.52|
71901405|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||1.52|0.57|
71901406|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.53|||||TWO_SIDED|95.0|0.95|2.47|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||2.47|0.95|
71901407|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.74|||||TWO_SIDED|95.0|0.41|1.34|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||1.34|0.41|
71901408|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.73|||||TWO_SIDED|95.0|0.34|1.57|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||1.57|0.34|
71901409|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.16|1.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||1.18|0.16|
71901410|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.59|||||TWO_SIDED|95.0|0.25|1.4|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||1.40|0.25|
71901411|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|0.79|||||TWO_SIDED|95.0|0.5|1.23|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||1.23|0.50|
71901412|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.14|||||TWO_SIDED|95.0|0.6|2.18|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.18|0.60|
71901413|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|1.08|||||TWO_SIDED|95.0|0.68|1.72|||||GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||1.72|0.68|
71901414|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.3|||||TWO_SIDED|95.0|2.44|43.49|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||43.49|2.44|
71679604|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4575|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.4575
71679605|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9706|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.9706
71679606|NCT02612610|142877089|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3258|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."||||0.3258
71679607|NCT02612610|142877090|OTHER||LS Mean Difference|0.0||||0.9858|TWO_SIDED|95.0|-0.53|0.54|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.54|-0.53|0.9858
71679608|NCT02612610|142877090|OTHER||LS Mean Difference|-0.01||||0.9813|TWO_SIDED|95.0|-0.53|0.52|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.52|-0.53|0.9813
71850854|NCT01020487|143215642|SUPERIORITY_OR_OTHER||Difference|-70.09||||0.043|TWO_SIDED|95.0|-137.82|-2.37|||Mixed Models Analysis|||Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-2.37|-137.82|0.043
71901415|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|6.17|||||TWO_SIDED|95.0|2.07|18.42|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||18.42|2.07|
71679609|NCT02612610|142877090|OTHER||LS Mean Difference|-0.11||||0.6746|TWO_SIDED|95.0|-0.65|0.42|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.42|-0.65|0.6746
71679610|NCT02612610|142877091|OTHER||LS Mean Difference|-0.32||||0.2583|TWO_SIDED|95.0|-0.88|0.24|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.24|-0.88|0.2583
71679611|NCT02612610|142877091|OTHER||LS Mean Difference|0.01||||0.9826|TWO_SIDED|95.0|-0.55|0.56|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.56|-0.55|0.9826
71679612|NCT02612610|142877091|OTHER||LS Mean Difference|-0.4||||0.1672|TWO_SIDED|95.0|-0.98|0.17|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.17|-0.98|0.1672
71850855|NCT01020487|143215642|SUPERIORITY_OR_OTHER||Difference|-88.52||||0.002|TWO_SIDED|95.0|-142.04|-35.01|||Mixed Models Analysis|||Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||-35.01|-142.04|0.002
71850856|NCT01020487|143215643|SUPERIORITY_OR_OTHER|||||||0.327|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.327
71850857|NCT01020487|143215644|SUPERIORITY_OR_OTHER|||||||0.194|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.||||||0.194
71850858|NCT01020487|143215645|SUPERIORITY_OR_OTHER||Difference|0.14||||0.469|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.53|-0.25|0.469
71850859|NCT01020487|143215645|SUPERIORITY_OR_OTHER||Difference|-0.01||||0.975|TWO_SIDED|95.0|-0.39|0.37|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.||0.37|-0.39|0.975
71850860|NCT01020487|143215645|SUPERIORITY_OR_OTHER||Difference|0.12||||0.567|TWO_SIDED|95.0|-0.32|0.56|||Mixed Models Analysis|||Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||0.56|-0.32|0.567
71819319|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.115||0.2903|TWO_SIDED|95.0|-0.35|0.11|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.35|0.2903
71819320|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.112||0.0395|TWO_SIDED|95.0|0.01|0.45|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|0.01|0.0395
71819321|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.108||0.469|TWO_SIDED|95.0|-0.14|0.29|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.14|0.4690
71850861|NCT01020487|143215645|SUPERIORITY_OR_OTHER||Difference|0.3||||0.462|TWO_SIDED|95.0|-0.53|1.12|||Mixed Models Analysis|||Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement||1.12|-0.53|0.462
71850862|NCT00307489|143215663|SUPERIORITY_OR_OTHER|||||||0.544||95.0||||P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||.544
71850863|NCT00307489|143215664|SUPERIORITY_OR_OTHER|||||||0.208||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.208
71850864|NCT00307489|143215665|SUPERIORITY_OR_OTHER|||||||0.712||95.0||||Controlling for baseline HBeAg and prior lamivudine use.|van Elteren|||||||0.712
71850865|NCT00307489|143215666|SUPERIORITY_OR_OTHER|||||||0.988||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.988
71850866|NCT00307489|143215667|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||Controlling for baseline HBeAg status and prior lamivudine use|Cochran-Mantel-Haenszel|||||||0.423
71850867|NCT00307489|143215668|SUPERIORITY_OR_OTHER|||||||0.109||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.109
71850868|NCT00307489|143215669|SUPERIORITY_OR_OTHER|||||||0.952||95.0|||||Cochran-Mantel-Haenszel|Controlling for baseline HBeAg and prior lamivudine use.||||||0.952
71850869|NCT00307489|143215670|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.655
71901416|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|18.7|||||TWO_SIDED|95.0|4.35|80.37|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||80.37|4.35|
71850870|NCT00307489|143215671|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
71850871|NCT00307489|143215672|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.401
71850872|NCT00307489|143215673|SUPERIORITY_OR_OTHER|||||||0.103||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.103
71850873|NCT00307489|143215674|SUPERIORITY_OR_OTHER|||||||0.999||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren|||||||0.999
71850874|NCT00307489|143215675|SUPERIORITY_OR_OTHER|||||||0.781||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.781
71850875|NCT00307489|143215676|SUPERIORITY_OR_OTHER|||||||0.936||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.936
71850876|NCT00307489|143215677|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.784
71850877|NCT00307489|143215678|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.703
71850878|NCT00307489|143215679|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
71850879|NCT00307489|143215680|SUPERIORITY_OR_OTHER|||||||0.254||95.0||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel|||||||0.254
71850880|NCT00307489|143215681|SUPERIORITY_OR_OTHER|||||||0.878||95.0|||||Cochran-Mantel-Haenszel|||||||0.878
71850881|NCT02964234|143215727|SUPERIORITY||Odds Ratio (OR)|10.59||||0.005|TWO_SIDED|95.0|2.01|56.31||We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.|Regression, Logistic|||We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).||56.31|2.01|.005
71850882|NCT02964234|143215728|SUPERIORITY||Slope|-0.19||||0.03|TWO_SIDED|95.0|-0.34|-0.04|||Regression, Linear|With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.||Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm\*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.||-0.04|-0.34|0.03
71819322|NCT02942004|143141929|SUPERIORITY||LS difference|0.07|STANDARD_ERROR_OF_MEAN|0.139||0.6066|TWO_SIDED|95.0|-0.2|0.35|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.20|0.6066
71819323|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.136||0.9737|TWO_SIDED|95.0|-0.26|0.27|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.26|0.9737
71819324|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.148||0.403|TWO_SIDED|95.0|-0.17|0.42|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.17|0.4030
71819325|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.145||0.6357|TWO_SIDED|95.0|-0.36|0.22|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.36|0.6357
71819326|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8605|TWO_SIDED|95.0|-0.29|0.24|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.29|0.8605
71819327|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.13||0.7534|TWO_SIDED|95.0|-0.3|0.22|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.30|0.7534
71819328|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.201||0.0021|TWO_SIDED|95.0|-1.03|-0.23|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-1.03|0.0021
71850883|NCT02964234|143215729|SUPERIORITY||Odds Ratio (OR)|6.15|||<|0.0001|TWO_SIDED|95.0|2.82|13.32||Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.|Ordinal regression|||We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).||13.32|2.82|<0.0001
71850884|NCT00234832|143215730|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.162||||0.015|TWO_SIDED|95.0|1.029|1.311||No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.|Log Rank||The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.|For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.||1.311|1.029|0.015
71850885|NCT00234832|143215730|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.948|TWO_SIDED|95.0|0.738|1.384|||Log Rank|||This analysis included only subjects with DM only in a comparison of sibutramine and placebo.||1.384|0.738|0.948
71901417|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.5|||||TWO_SIDED|95.0|1.14|5.52|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||5.52|1.14|
71850886|NCT00234832|143215730|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.149|TWO_SIDED|95.0|0.916|1.776|||Log Rank|||This analysis included only subjects with CV only in a comparison of sibutramine and placebo.||1.776|0.916|0.149
71679613|NCT02612610|142877092|OTHER||LS Mean Difference|0.14||||0.6102|TWO_SIDED|95.0|-0.4|0.68|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.68|-0.4|0.6102
71819329|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.196||0.0394|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0394
71850887|NCT00234832|143215730|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.182||||0.022|TWO_SIDED|95.0|1.024|1.365|||Log Rank|||This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.||1.365|1.024|0.022
71901418|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.24|||||TWO_SIDED|95.0|2.33|11.8|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||11.80|2.33|
71850888|NCT00234832|143215731|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.043||||0.543|TWO_SIDED|95.0|0.91|1.196|||Log Rank|||||1.196|0.910|0.543
71850889|NCT00234832|143215732|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.097||||0.051|TWO_SIDED|95.0|0.999|1.204|||Log Rank|||||1.204|0.999|0.051
71850890|NCT00234832|143215733|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.276||||0.022|TWO_SIDED|95.0|1.036|1.571|||Log Rank|||||1.571|1.036|0.022
71850891|NCT00234832|143215734|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.355||||0.025|TWO_SIDED|95.0|1.038|1.767|||Log Rank|||||1.767|1.038|0.025
71850892|NCT00234832|143215735|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.582||||0.343|TWO_SIDED|95.0|0.613|4.081|||Log Rank|||||4.081|0.613|0.343
71850893|NCT00234832|143215736|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.988||||0.899|TWO_SIDED|95.0|0.822|1.188|||Log Rank|||||1.188|0.822|0.899
71850894|NCT04454125|143215749|SUPERIORITY||Odds Ratio (OR)|0.61||||0.32|TWO_SIDED|95.0|0.23|1.61|||Generalized linear model, repeat measure|Generalized linear model (GLM) fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group arm, visit, interaction term (arm\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.61|0.23|0.32
71850895|NCT04454125|143215749|SUPERIORITY||Odds Ratio (OR)|0.31||||0.29|TWO_SIDED|95.0|0.03|2.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||2.76|0.03|0.29
71850896|NCT04454125|143215749|SUPERIORITY||Odds Ratio (OR)|0.51||||0.58|TWO_SIDED|95.0|0.05|5.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link||Outcome= severe asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 severe asthma exacerbation.|5.68|0.05|0.58
71850897|NCT04454125|143215749|SUPERIORITY||Odds Ratio (OR)|0.5||||0.02|TWO_SIDED|95.0|0.27|0.91|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.91|0.27|0.02
71850898|NCT04454125|143215749|SUPERIORITY||Odds Ratio (OR)|0.23||||0.03|TWO_SIDED|95.0|0.06|0.86|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||0.86|0.06|0.03
71850899|NCT04454125|143215749|SUPERIORITY||Odds Ratio (OR)|0.47||||0.3|TWO_SIDED|95.0|0.11|1.95|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit) and adjusting for visit 2 moderate asthma exacerbation.|Outcome= moderate asthma exacerbation at visit (yes, no), collected via questionnaire at visits 2-7(exit). Does not include randomization (visit 1).||1.95|0.11|0.30
71850900|NCT04454125|143215750|SUPERIORITY||Mean Difference (Net)|0.17||||0.8|TWO_SIDED|95.0|-1.17|1.51|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||1.51|-1.17|0.80
71850901|NCT04454125|143215750|SUPERIORITY||Mean Difference (Net)|2.02||||0.001|TWO_SIDED|95.0|0.88|3.15|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.15|0.88|0.001
71850902|NCT04454125|143215750|SUPERIORITY||Mean Difference (Net)|1.85||||0.04|TWO_SIDED|95.0|0.09|3.61|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Asthma Control Test Score. Obtained at all visits.||3.61|0.09|0.04
71679614|NCT02612610|142877092|OTHER||LS Mean Difference|0.08||||0.7782|TWO_SIDED|95.0|-0.46|0.61|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.61|-0.46|0.7782
71679615|NCT02612610|142877092|OTHER||LS Mean Difference|0.28||||0.3167|TWO_SIDED|95.0|-0.27|0.83|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."||0.83|-0.27|0.3167
71679616|NCT02612610|142877093|OTHER||LS Mean Difference|0.3||||0.1545|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.1545
71679617|NCT02612610|142877093|OTHER||LS Mean Difference|0.3||||0.2013|TWO_SIDED|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.7|-0.1|0.2013
71679618|NCT02612610|142877093|OTHER||LS Mean Difference|0.0||||0.9962|TWO_SIDED|95.0|-0.4|0.4|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.4|0.9962
71679619|NCT02612610|142877094|OTHER||LS Mean Difference|0.1||||0.7328|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7328
71679620|NCT02612610|142877094|OTHER||LS Mean Difference|0.1||||0.7635|TWO_SIDED|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.4|0.7635
71679621|NCT02612610|142877094|OTHER||LS Mean Difference|-0.4||||0.0951|TWO_SIDED|95.0|-0.9|0.1|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-0.9|0.0951
71679622|NCT02612610|142877095|OTHER||LS Mean Difference|-0.2||||0.5797|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5797
71819330|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.208||0.0039|TWO_SIDED|95.0|-1.03|-0.2|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.03|0.0039
71819331|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.1591|TWO_SIDED|95.0|-0.69|0.11|||MMRM|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.69|0.1591
71850903|NCT04454125|143215750|SUPERIORITY||Mean Difference (Net)|-0.31||||0.7|TWO_SIDED|95.0|-1.87|1.25|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||1.25|-1.87|0.70
71679623|NCT02612610|142877095|OTHER||LS Mean Difference|-0.3||||0.2499|TWO_SIDED|95.0|-0.9|0.2|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-0.9|0.2499
71901419|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|3.77|||||TWO_SIDED|95.0|1.47|9.65|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||9.65|1.47|
71679624|NCT02612610|142877095|OTHER||LS Mean Difference|-0.5||||0.0612|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0612
71819332|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.21||0.1402|TWO_SIDED|95.0|-0.73|0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.73|0.1402
71819333|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.205||0.0143|TWO_SIDED|95.0|-0.91|-0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.91|0.0143
71819334|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.204||0.2293|TWO_SIDED|95.0|-0.65|0.16|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.65|0.2293
71819335|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.2||0.0884|TWO_SIDED|95.0|-0.74|0.05|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.74|0.0884
71819336|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.207||0.0622|TWO_SIDED|95.0|-0.8|0.02|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.80|0.0622
71819337|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.202||0.0955|TWO_SIDED|95.0|-0.74|0.06|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.74|0.0955
71819338|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0173|TWO_SIDED|95.0|-0.92|-0.09|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.92|0.0173
71679625|NCT02612610|142877096|OTHER||LS Mean Difference|-0.2||||0.5358|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5358
71819339|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.206||0.1687|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1687
71819340|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.258||0.3861|TWO_SIDED|95.0|-0.74|0.29|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.74|0.3861
71819341|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.249||0.706|TWO_SIDED|95.0|-0.59|0.4|||MMRM|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.59|0.7060
71819342|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.0112|TWO_SIDED|95.0|-1.05|-0.14|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-1.05|0.0112
71819343|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.219||0.057|TWO_SIDED|95.0|-0.86|0.01|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.86|0.0570
71901420|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.94|||||TWO_SIDED|95.0|1.65|21.36|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||21.36|1.65|
71901421|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.44|||||TWO_SIDED|95.0|1.17|16.87|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||16.87|1.17|
71901422|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|90.8|||||TWO_SIDED|95.0|16.67|494.56|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||494.56|16.67|
71901423|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.83|||||TWO_SIDED|95.0|3.79|83.78|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||83.78|3.79|
71901424|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|8.11|||||TWO_SIDED|95.0|3.6|18.3|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||18.30|3.60|
71901425|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|15.29|||||TWO_SIDED|95.0|4.64|50.35|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||50.35|4.64|
71901426|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.19|||||TWO_SIDED|95.0|1.72|10.25|||||GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||10.25|1.72|
71901427|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|13.93|||||TWO_SIDED|95.0|9.14|21.23|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||21.23|9.14|
71901428|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|5.86|||||TWO_SIDED|95.0|4.17|8.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||8.24|4.17|
71679626|NCT02612610|142877096|OTHER||LS Mean Difference|-0.3||||0.3129|TWO_SIDED|95.0|-0.8|0.3|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.8|0.3129
71819344|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.208||0.0018|TWO_SIDED|95.0|-1.08|-0.26|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-1.08|0.0018
71901429|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|19.97|||||TWO_SIDED|95.0|12.8|31.15|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||31.15|12.80|
71901430|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|2.46|||||TWO_SIDED|95.0|1.87|3.24|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||3.24|1.87|
71819345|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.205||0.0443|TWO_SIDED|95.0|-0.83|-0.01|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.83|0.0443
71819346|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.104||0.1197|TWO_SIDED|95.0|-0.04|0.37|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.04|0.1197
71819347|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.101||0.7171|TWO_SIDED|95.0|-0.24|0.16|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.24|0.7171
71819348|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7151|TWO_SIDED|95.0|-0.32|0.22|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.32|0.7151
71819349|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.134||0.521|TWO_SIDED|95.0|-0.35|0.18|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.35|0.5210
71819350|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.142||0.7332|TWO_SIDED|95.0|-0.23|0.33|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.23|0.7332
71819351|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.139||0.4163|TWO_SIDED|95.0|-0.39|0.16|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.39|0.4163
71819352|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.132||0.8625|TWO_SIDED|95.0|-0.28|0.24|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.28|0.8625
71882996|NCT00876187|143285161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.2||0.688|TWO_SIDED|95.0|-0.31|0.47|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.47|-0.31|0.688
71882997|NCT00876187|143285161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.76|-0.03|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.76|0.035
71882998|NCT00876187|143285161|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.19||0.006|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.88|0.006
71882999|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.18||0.221|TWO_SIDED|95.0|-0.57|0.13|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.13|-0.57|0.221
71883000|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.24|-0.90|<0.001
71883001|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.027|TWO_SIDED|95.0|-0.7|-0.04|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.70|0.027
71883002|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.17||0.082|TWO_SIDED|95.0|-0.04|0.62|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.62|-0.04|0.082
71819353|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6196|TWO_SIDED|95.0|-0.32|0.19|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.32|0.6196
71819354|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.197||0.0373|TWO_SIDED|95.0|-0.8|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.80|0.0373
71819355|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.191||0.0644|TWO_SIDED|95.0|-0.74|0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.74|0.0644
71819356|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.191||0.1347|TWO_SIDED|95.0|-0.66|0.09|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.66|0.1347
71819357|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.185||0.1269|TWO_SIDED|95.0|-0.65|0.08|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.65|0.1269
71819358|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.192||0.165|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1650
71819359|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1291|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1291
71819360|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.189||0.0402|TWO_SIDED|95.0|-0.77|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.77|0.0402
71819361|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.185||0.0342|TWO_SIDED|95.0|-0.76|-0.03|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.76|0.0342
71819362|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.193||0.1269|TWO_SIDED|95.0|-0.68|0.09|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.68|0.1269
71819363|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.188||0.3945|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3945
71819364|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.185||0.5828|TWO_SIDED|95.0|-0.47|0.26|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.47|0.5828
71679627|NCT02612610|142877096|OTHER||LS Mean Difference|-0.5||||0.1046|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1046
71901431|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.12|||||TWO_SIDED|95.0|5.05|10.03|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||10.03|5.05|
71679628|NCT02612610|142877097|OTHER||LS Mean Difference|-0.2||||0.5796|TWO_SIDED|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.7|0.5796
71883003|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.703|TWO_SIDED|95.0|-0.37|0.25|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.25|-0.37|0.703
71883004|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.16||0.379|TWO_SIDED|95.0|-0.17|0.45|||ANCOVA|||Change at Week 2: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.45|-0.17|0.379
71883005|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|-0.87|-0.11|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.11|-0.87|0.012
71883006|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.39|-0.67|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.67|-1.39|<0.001
71883007|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.31|-0.58|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.58|-1.31|<0.001
71883008|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.862|TWO_SIDED|95.0|-0.33|0.39|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.39|-0.33|0.862
71883009|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.17||0.003|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.17|-0.85|0.003
71883010|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.014|TWO_SIDED|95.0|-0.76|-0.09|||ANCOVA|||Change at Week 4: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.09|-0.76|0.014
71883011|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.2||0.019|TWO_SIDED|95.0|-0.86|-0.08|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.08|-0.86|0.019
71883012|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.51|-1.25|<0.001
71883013|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.56|-1.29|<0.001
71883014|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.19||0.668|TWO_SIDED|95.0|-0.45|0.29|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.29|-0.45|0.668
71883015|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.005|TWO_SIDED|95.0|-0.84|-0.15|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.15|-0.84|0.005
71883016|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.18||0.002|TWO_SIDED|95.0|-0.88|-0.19|||ANCOVA|||Change at Week 8: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.19|-0.88|0.002
71883017|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.22||0.032|TWO_SIDED|95.0|-0.89|-0.04|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.04|-0.89|0.032
71901432|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|7.78|||||TWO_SIDED|95.0|5.54|10.92|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||10.92|5.54|
71901433|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|10.4|||||TWO_SIDED|95.0|7.4|14.61|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||14.61|7.40|
71679629|NCT02612610|142877097|OTHER||LS Mean Difference|-0.4||||0.143|TWO_SIDED|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.0|0.1430
71901434|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.07|||||TWO_SIDED|95.0|3.04|5.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||5.47|3.04|
71901435|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|60.32|||||TWO_SIDED|95.0|37.25|97.67|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||97.67|37.25|
71901436|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|17.35|||||TWO_SIDED|95.0|11.37|26.47|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||26.47|11.37|
71901437|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|4.11|||||TWO_SIDED|95.0|3.0|5.62|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||5.62|3.00|
71901438|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.68|||||TWO_SIDED|95.0|6.65|14.08|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||14.08|6.65|
71901439|NCT05372575|143324928|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student's t distribution.|GMR|9.7|||||TWO_SIDED|95.0|6.9|13.64|||||GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||13.64|6.90|
71901440|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.49|||||TWO_SIDED|95.0|0.06|3.91|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 1||3.91|0.06|
71901441|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.54|||||TWO_SIDED|95.0|0.1|2.92|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 3||2.92|0.10|
71901442|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.45|||||TWO_SIDED|95.0|0.1|2.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 4||2.07|0.10|
71901443|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.78|||||TWO_SIDED|95.0|0.27|11.75|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 5||11.75|0.27|
71901444|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.23|||||TWO_SIDED|95.0|0.03|1.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6A||1.65|0.03|
71901445|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.06|||||TWO_SIDED|95.0|0.01|0.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 6B||0.44|0.01|
71901446|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.21|||||TWO_SIDED|95.0|0.56|2.65|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 7F||2.65|0.56|
71901447|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.2|||||TWO_SIDED|95.0|0.03|1.26|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 9V||1.26|0.03|
71901448|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.36|||||TWO_SIDED|95.0|0.08|1.55|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 14||1.55|0.08|
71901449|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.82|||||TWO_SIDED|95.0|0.15|4.47|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 18C||4.47|0.15|
71850904|NCT04454125|143215750|SUPERIORITY||Mean Difference (Net)|3.96||||0.14|TWO_SIDED|95.0|-1.27|9.2|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Score. Obtained at all visits.||9.20|-1.27|0.14
71850905|NCT04454125|143215750|SUPERIORITY||Mean Difference (Net)|4.27||||0.13|TWO_SIDED|95.0|-1.19|9.73|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome=Childhood Asthma Control Test Scores.||9.73|-1.19|0.13
71901450|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.35|||||TWO_SIDED|95.0|0.19|9.44|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19A||9.44|0.19|
71901451|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.87|||||TWO_SIDED|95.0|0.67|22.42|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 19F||22.42|0.67|
71901452|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.27|||||TWO_SIDED|95.0|0.05|1.52|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in 13vPnC Cohort for Serotype: 23F||1.52|0.05|
71679630|NCT02612610|142877097|OTHER||LS Mean Difference|-0.7||||0.0221|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0221
71901453|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.76|||||TWO_SIDED|95.0|0.19|3.07|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 1||3.07|0.19|
71901454|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.02|||||TWO_SIDED|95.0|0.42|2.46|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 3||2.46|0.42|
71901455|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.44|||||TWO_SIDED|95.0|0.05|3.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 4||3.73|0.05|
71901456|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.15|2.73|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 5||2.73|0.15|
71901457|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.88|||||TWO_SIDED|95.0|0.11|6.99|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6A||6.99|0.11|
71850906|NCT04454125|143215751|SUPERIORITY||Mean Difference (Net)|0.25||||0.11|TWO_SIDED|95.0|-0.06|0.55|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.55|-0.06|0.11
71850907|NCT04454125|143215751|SUPERIORITY||Mean Difference (Net)|0.54||||0.002|TWO_SIDED|95.0|0.2|0.88|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.88|0.20|0.002
71901458|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.9|||||TWO_SIDED|95.0|0.29|12.51|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 6B||12.51|0.29|
71901459|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.45|||||TWO_SIDED|95.0|0.34|17.43|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 7F||17.43|0.34|
71901460|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.43|||||TWO_SIDED|95.0|0.27|7.7|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 9V||7.70|0.27|
71901461|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.3|||||TWO_SIDED|95.0|0.3|17.41|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 14||17.41|0.30|
71901462|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.65|||||TWO_SIDED|95.0|0.14|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 18C||2.97|0.14|
71679631|NCT02612610|142877098|OTHER||LS Mean Difference|-0.4||||0.1562|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1562
71901463|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.51|||||TWO_SIDED|95.0|0.28|8.21|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19A||8.21|0.28|
71901464|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.63|||||TWO_SIDED|95.0|0.13|2.97|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 19F||2.97|0.13|
71901465|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|1.23|||||TWO_SIDED|95.0|0.15|10.24|||||GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)|GMR of VT+ Subgroup/VT- or Sp- Subgroup in non-13vPnC Cohort for Serotype: 23F||10.24|0.15|
71901466|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.15|||||TWO_SIDED|95.0|0.41|23.91|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 1||23.91|0.41|
71901467|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|5.02|||||TWO_SIDED|95.0|1.45|17.39|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 3||17.39|1.45|
71901468|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.7|||||TWO_SIDED|95.0|1.32|141.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 4||141.81|1.32|
71901469|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.41|||||TWO_SIDED|95.0|6.16|380.54|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 5||380.54|6.16|
71679632|NCT02612610|142877098|OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.1|0.0710
71850908|NCT04454125|143215751|SUPERIORITY||Mean Difference (Net)|0.3||||0.2|TWO_SIDED|95.0|-0.16|0.75|||generalized linear model, repeat measure|GLM fitted with Normal/Gaussian distribution and identity link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Pediatric Asthma Quality of Life Questionnaire. Obtained at randomization and exit visits (visit 1 and visit 7).||0.75|-0.16|0.20
71850909|NCT04454125|143215752|SUPERIORITY||Odds Ratio (OR)|0.94||||0.87|TWO_SIDED|95.0|0.45|1.96|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||1.96|0.45|0.87
71850910|NCT04454125|143215752|SUPERIORITY||Odds Ratio (OR)|6.89||||0.004|TWO_SIDED|95.0|1.85|25.6|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||25.6|1.85|0.004
71850911|NCT04454125|143215752|SUPERIORITY||Odds Ratio (OR)|7.31||||0.01|TWO_SIDED|95.0|1.62|32.9|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported checking the AQI prior to going outside to be active||32.9|1.62|0.01
71850912|NCT04454125|143215753|SUPERIORITY||Odds Ratio (OR)|0.34||||0.15|TWO_SIDED|95.0|0.08|1.47|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||1.47|0.08|0.15
71850913|NCT04454125|143215753|SUPERIORITY||Odds Ratio (OR)|0.96||||0.94|TWO_SIDED|95.0|0.35|2.68|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||2.68|0.35|0.94
71850914|NCT04454125|143215753|SUPERIORITY||Odds Ratio (OR)|2.79||||0.26|TWO_SIDED|95.0|0.47|16.5|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Outcome: Reported outdoor activity behavioral change in response to the AQI, obtained at all visits.||16.5|0.47|0.26
71850915|NCT04454125|143215754|SUPERIORITY||Odds Ratio (OR)|0.42||||0.004|TWO_SIDED|95.0|0.24|0.76|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the control group (Routine Care) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits||0.76|0.24|0.004
71850916|NCT04454125|143215754|SUPERIORITY||Odds Ratio (OR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.05|0.31|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the intervention group (AQI Intervention) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.31|0.05|<0.0001
71850917|NCT04454125|143215754|SUPERIORITY||Odds Ratio (OR)|0.29||||0.03|TWO_SIDED|95.0|0.1|0.87|||generalized linear model, repeat measure|GLM fitted with binomial distribution and logit link|Estimate is for the interaction term (group\*visit) obtained from generalized linear model with repeat measures including group, visit, interaction term (group\*visit).|Obtained at all visits.||0.87|0.10|0.03
71850918|NCT01922102|143215861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.2|||<|0.001|TWO_SIDED|95.0|3.3|7.1||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.||7.1|3.3|<0.001
71883018|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.21|-0.41|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.41|-1.21|<0.001
71883019|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.28|-0.48|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.48|-1.28|<0.001
71883020|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.2||0.773|TWO_SIDED|95.0|-0.46|0.34|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||0.34|-0.46|0.773
71883021|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.78|-0.03|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.03|-0.78|0.035
71819365|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.182||0.6625|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6625
71819366|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.216||0.0041|TWO_SIDED|95.0|-1.07|-0.21|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.07|0.0041
71819367|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.21||0.2222|TWO_SIDED|95.0|-0.67|0.16|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.67|0.2222
71819368|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.218||0.0245|TWO_SIDED|95.0|-0.93|-0.07|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.93|0.0245
71819369|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.209||0.5119|TWO_SIDED|95.0|-0.55|0.28|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.55|0.5119
71819370|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.197||0.0299|TWO_SIDED|95.0|-0.82|-0.04|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.82|0.0299
71819371|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.195||0.2824|TWO_SIDED|95.0|-0.6|0.18|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.60|0.2824
71819372|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.129||0.1768|TWO_SIDED|95.0|-0.08|0.43|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.08|0.1768
71819373|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.126||0.6498|TWO_SIDED|95.0|-0.31|0.19|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.31|0.6498
71819374|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.7689|TWO_SIDED|95.0|-0.25|0.34|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.25|0.7689
71819375|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.146||0.2236|TWO_SIDED|95.0|-0.47|0.11|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.47|0.2236
71819376|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.35|0.23|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.35|0.6952
71883022|NCT00876187|143285164|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.85|-0.1|||ANCOVA|||Change at Week 12: Treatment difference and 95% CI was based on LS mean. ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.||-0.10|-0.85|0.014
71883023|NCT01560780|143285201|SUPERIORITY|||||||0.78|||||||Fisher Exact|||||||0.78
71901470|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.47|||||TWO_SIDED|95.0|0.48|229.1|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6A||229.10|0.48|
71901471|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|0.68|||||TWO_SIDED|95.0|0.02|19.83|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 6B||19.83|0.02|
71901472|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.53|||||TWO_SIDED|95.0|1.98|55.96|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 7F||55.96|1.98|
71901473|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|3.32|||||TWO_SIDED|95.0|0.19|56.82|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 9V||56.82|0.19|
71901474|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|2.0|||||TWO_SIDED|95.0|0.06|63.12|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 14||63.12|0.06|
71901475|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|16.31|||||TWO_SIDED|95.0|2.15|123.48|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 18C||123.48|2.15|
71901476|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|24.16|||||TWO_SIDED|95.0|1.59|367.81|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19A||367.81|1.59|
71901477|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|95.06|||||TWO_SIDED|95.0|13.08|691.01|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 19F||691.01|13.08|
71901478|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|10.49|||||TWO_SIDED|95.0|0.64|171.84|||||GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT+ Subgroups for Serotype: 23F||171.84|0.64|
71901479|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|4.86|||||TWO_SIDED|95.0|2.15|10.96|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 1||10.96|2.15|
71901480|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|9.57|||||TWO_SIDED|95.0|4.5|20.36|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 3||20.36|4.50|
71901481|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|13.4|||||TWO_SIDED|95.0|5.2|34.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 4||34.51|5.20|
71901482|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|17.15|||||TWO_SIDED|95.0|7.76|37.91|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 5||37.91|7.76|
71679633|NCT02612610|142877098|OTHER||LS Mean Difference|-0.7||||0.0274|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.2|0.0274
71679634|NCT02612610|142877099|OTHER||LS Mean Difference|-0.2||||0.4464|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4464
71819377|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.144||0.1184|TWO_SIDED|95.0|-0.51|0.06|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.51|0.1184
71819378|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.149||0.3031|TWO_SIDED|95.0|-0.14|0.45|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.14|0.3031
71819379|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.145||0.3091|TWO_SIDED|95.0|-0.44|0.14|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.44|0.3091
71819380|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.179||0.1525|TWO_SIDED|95.0|-0.61|0.1|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.61|0.1525
71819381|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.174||0.1214|TWO_SIDED|95.0|-0.62|0.07|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.62|0.1214
71819382|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3811|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3811
71850919|NCT01922102|143215861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|||<|0.001|TWO_SIDED|95.0|3.5|7.6||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|"The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:~H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT \> 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT \> 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively."||7.6|3.5|<0.001
71679635|NCT02612610|142877099|OTHER||LS Mean Difference|-0.3||||0.332|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.3320
71819383|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.18||0.3851|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3851
71819384|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.182||0.1373|TWO_SIDED|95.0|-0.63|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.63|0.1373
71850920|NCT01922102|143215862|NON_INFERIORITY_OR_EQUIVALENCE|"one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I \> -5.~Otherwise, H03 was not to be considered as rejected."|Mean Difference (Net)|0.4|||<|0.001|TWO_SIDED|95.0|-1.3|2.1||Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|||2.1|-1.3|<0.001
71819385|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.136|TWO_SIDED|95.0|-0.62|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.62|0.1360
71819386|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.176||0.1264|TWO_SIDED|95.0|-0.62|0.08|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.62|0.1264
71819387|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.172||0.0567|TWO_SIDED|95.0|-0.67|0.01|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.67|0.0567
71819388|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.176||0.7447|TWO_SIDED|95.0|-0.41|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.41|0.7447
71819389|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.172||0.7727|TWO_SIDED|95.0|-0.39|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.39|0.7727
71819390|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.183||0.659|TWO_SIDED|95.0|-0.28|0.44|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.28|0.6590
71819391|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.18||0.3951|TWO_SIDED|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.51|0.3951
71819392|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.23||0.4576|TWO_SIDED|95.0|-0.63|0.28|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.63|0.4576
71819393|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.223||0.7609|TWO_SIDED|95.0|-0.51|0.37|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.51|0.7609
71819394|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.234||0.622|TWO_SIDED|95.0|-0.58|0.35|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.58|0.6220
71819395|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.9081|TWO_SIDED|95.0|-0.42|0.47|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.42|0.9081
71850921|NCT01799993|143215877|SUPERIORITY||Odds Ratio (OR)|0.841||||0.4263|TWO_SIDED|95.0|0.554|1.277|||Cochran-Mantel-Haenszel|||||1.277|0.554|0.4263
71850922|NCT01799993|143215878|SUPERIORITY|||||||0.6421|||||||Chi-squared|||||||0.6421
71850923|NCT01799993|143215879|SUPERIORITY|||||||0.7984|||||||Chi-squared|||||||0.7984
71819396|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.191||0.1668|TWO_SIDED|95.0|-0.65|0.11|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.65|0.1668
71850924|NCT01799993|143215880|SUPERIORITY|||||||0.7144|||||||ANOVA|||||||0.7144
71850925|NCT01799993|143215881|SUPERIORITY|||||||0.4278|||||||ANOVA|||||||0.4278
71850926|NCT02823574|143215913|SUPERIORITY||Odds Ratio (OR)|0.68||||0.2897|TWO_SIDED|95.5|0.33|1.43|||Mantel Haenszel|||Treatment A over Treatment B||1.43|0.33|0.2897
71850927|NCT02823574|143215918|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PD-L1 and HPV status|||1.41|0.78|
71819397|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.189||0.0935|TWO_SIDED|95.0|-0.69|0.05|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.69|0.0935
71819398|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.4038|TWO_SIDED|95.0|-0.42|0.17|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.42|0.4038
71819399|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.145||0.7559|TWO_SIDED|95.0|-0.24|0.33|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.33|-0.24|0.7559
71819400|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.181||0.2006|TWO_SIDED|95.0|-0.59|0.13|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.59|0.2006
71819401|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.175||0.6334|TWO_SIDED|95.0|-0.26|0.43|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.26|0.6334
71819402|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.5431|TWO_SIDED|95.0|-0.6|0.32|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.60|0.5431
71819403|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.225||0.5278|TWO_SIDED|95.0|-0.3|0.59|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.59|-0.30|0.5278
71850928|NCT02823574|143215919|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.78|1.41|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.41|0.78|
71850929|NCT02823574|143215920|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.87|1.36|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.36|0.87|
71850930|NCT02823574|143215921|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.81|1.45|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.45|0.81|
71850931|NCT02823574|143215922|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.81|1.61|||||computed using a cox proportional hazard model stratified by randomization PDL-1 and HPV status|||1.61|0.81|
71850932|NCT02823574|143215947|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.32|1.29|||Mantel Haenszel|||Treatment A over Treatment B||1.29|0.32|
71850933|NCT01494467|143215950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71850934|NCT01494467|143215951|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-8.22|||<|0.001|TWO_SIDED|95.0|-10.18|-6.25|||ANCOVA|||||-6.25|-10.18|<0.001
71850935|NCT01494467|143215952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71850936|NCT02009332|143216001|OTHER||maximum deliverable dose (MDD)|400.0|||||TWO_SIDED||||||||Maximum deliverable dose (MDD) was not reached in the Phase 1 study as no DLTs were observed in any of the dose groups up to ABI-009 400 mg/week.|||||
71883024|NCT01560780|143285202|EQUIVALENCE|safety end-point with p-value of \<0.05|||||>|0.99|||||||Log Rank|||||||>0.99
71819404|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.232||0.4312|TWO_SIDED|95.0|-0.64|0.28|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.64|0.4312
71819405|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.225||0.3947|TWO_SIDED|95.0|-0.25|0.64|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.64|-0.25|0.3947
71850937|NCT04739306|143216004|EQUIVALENCE|Predefined equivalence margin: -3 letters to +3 letters|Estimated difference in LS means|0.58|||||TWO_SIDED|90.0|-0.52|1.67|||ANCOVA|Analysis conducted for study eye. Primary endpoint as the dependent variable, treatment as a factor, baseline BCVA and country as covariates.||||1.67|-0.52|
71850938|NCT01077284|143216009|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.001
71850939|NCT01077284|143216009|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.003
71850940|NCT01077284|143216010|SUPERIORITY_OR_OTHER|||||||0.13||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.130
71850941|NCT01077284|143216010|SUPERIORITY_OR_OTHER|||||||0.348||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.348
71850942|NCT01077284|143216011|SUPERIORITY_OR_OTHER|||||||0.403||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.403
71850943|NCT01077284|143216011|SUPERIORITY_OR_OTHER|||||||0.413||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)|||||||0.413
71850944|NCT01077284|143216012|SUPERIORITY_OR_OTHER|||||||0.5535||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.5535
71850945|NCT01077284|143216012|SUPERIORITY_OR_OTHER|||||||0.94||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.||||||0.9400
71819406|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.244||0.6081|TWO_SIDED|95.0|-0.61|0.36|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.61|0.6081
71850946|NCT01180400|143216013|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.91||0.944|TWO_SIDED|95.0|-1.86|1.73||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.73|-1.86|0.944
71850947|NCT01180400|143216014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.26||0.974|TWO_SIDED|95.0|0.61|1.66|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.66|0.61|0.974
71850948|NCT01180400|143216015|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.41||0.184|TWO_SIDED|95.0|0.84|2.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.53|0.84|0.184
71850949|NCT01180400|143216016|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.71||0.461|TWO_SIDED|95.0|0.55|3.78|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||3.78|0.55|0.461
71850950|NCT01180400|143216017|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87|STANDARD_ERROR_OF_MEAN|0.31||0.689|TWO_SIDED|95.0|0.43|1.75|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.75|0.43|0.689
71883025|NCT01560780|143285203|SUPERIORITY|||||||0.19|||||||Fisher Exact|||||||0.19
71883026|NCT01560780|143285204|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||||||0.85
71850951|NCT01180400|143216018|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.44||0.831|TWO_SIDED|95.0|0.35|2.32|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.32|0.35|0.831
71819407|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.238||0.8949|TWO_SIDED|95.0|-0.44|0.5|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.44|0.8949
71819408|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.236||0.112|TWO_SIDED|95.0|-0.84|0.09|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.09|-0.84|0.1120
71819409|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.228||0.1842|TWO_SIDED|95.0|-0.15|0.76|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.15|0.1842
71819410|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.26||0.2646|TWO_SIDED|95.0|-0.81|0.22|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.81|0.2646
71819411|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.253||0.8101|TWO_SIDED|95.0|-0.56|0.44|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.56|0.8101
71819412|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.248||0.0215|TWO_SIDED|95.0|-1.07|-0.09|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-1.07|0.0215
71819413|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.242||0.3226|TWO_SIDED|95.0|-0.72|0.24|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.72|0.3226
71819414|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.238||0.0339|TWO_SIDED|95.0|-0.98|-0.04|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.98|0.0339
71819415|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.232||0.9824|TWO_SIDED|95.0|-0.46|0.47|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.46|0.9824
71819416|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.254||0.095|TWO_SIDED|95.0|-0.93|0.08|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.93|0.0950
71850952|NCT01180400|143216019|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.525|TWO_SIDED|95.0|-0.96|1.89|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.89|-0.96|0.525
71883027|NCT01560780|143285205|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71883028|NCT01560780|143285207|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71883029|NCT02915523|143285219|OTHER||Hazard Ratio (HR)|0.899|||||TWO_SIDED|95.0|0.581|1.393|||||Stratified HR estimated from a stratified univeriate Cox proportional hazards model. Avelumab + placebo was the reference treatment group.|||1.393|0.581|
71850953|NCT01180400|143216020|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.964||95.0|-0.28|0.26|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.26|-0.28|0.964
71819417|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.249||0.4865|TWO_SIDED|95.0|-0.67|0.32|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.67|0.4865
71850954|NCT01180400|143216021|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.25||0.783|TWO_SIDED|95.0|0.54|1.58|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.58|0.54|0.783
71819418|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.292||0.9861|TWO_SIDED|95.0|-0.57|0.58|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|-0.57|0.9861
71850955|NCT01180400|143216022|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.832|TWO_SIDED|95.0|-0.89|1.11||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-0.89|0.832
71850956|NCT01180400|143216023|SUPERIORITY_OR_OTHER||LS mean|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.468|TWO_SIDED|95.0|-0.84|1.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.82|-0.84|0.468
71850957|NCT01180400|143216024|SUPERIORITY_OR_OTHER||LS mean|1.0|STANDARD_ERROR_OF_MEAN|0.77||0.187|TWO_SIDED|95.0|-0.49|2.52|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.52|-0.49|0.187
71850958|NCT01180400|143216025|SUPERIORITY_OR_OTHER||LS mean|1.3|STANDARD_ERROR_OF_MEAN|0.86||0.145|TWO_SIDED|95.0|-0.44|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||2.95|-0.44|0.145
71850959|NCT01180400|143216026|SUPERIORITY_OR_OTHER||LS mean|-0.04|STANDARD_ERROR_OF_MEAN|0.766||0.956|TWO_SIDED|95.0|-1.549|1.466||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.466|-1.549|0.956
71679636|NCT02612610|142877099|OTHER||LS Mean Difference|-0.5||||0.0792|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.0792
71679637|NCT02612610|142877100|OTHER||LS Mean Difference|-0.2||||0.4716|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4716
71679638|NCT02612610|142877100|OTHER||LS Mean Difference|-0.2||||0.4371|TWO_SIDED|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.8|0.4371
71679639|NCT02612610|142877100|OTHER||LS Mean Difference|-0.4||||0.1907|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1907
71679640|NCT02612610|142877101|OTHER||LS Mean Difference|-0.3||||0.2772|TWO_SIDED|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-0.9|0.2772
71679641|NCT02612610|142877101|OTHER||LS Mean Difference|-0.5||||0.1132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.1|0.1132
71679642|NCT02612610|142877101|OTHER||LS Mean Difference|-0.6||||0.0737|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0737
71679643|NCT02612610|142877102|OTHER||LS Mean Difference|-0.1||||0.6266|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6266
71679644|NCT02612610|142877102|OTHER||LS Mean Difference|-0.4||||0.1769|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.1769
71679645|NCT02612610|142877102|OTHER||LS Mean Difference|-0.7||||0.0313|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.3|0.0313
71679646|NCT02612610|142877103|OTHER||LS Mean Difference|-0.4||||0.2058|TWO_SIDED|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.0|0.2058
71819419|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.283||0.9266|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.54|-0.59|0.9266
71819420|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.285||0.036|TWO_SIDED|95.0|-1.17|-0.04|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-1.17|0.0360
71819421|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.273||0.0583|TWO_SIDED|95.0|-1.06|0.02|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-1.06|0.0583
71679647|NCT02612610|142877103|OTHER||LS Mean Difference|-0.6||||0.0665|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0665
71819422|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0404|TWO_SIDED|95.0|-1.03|-0.02|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-1.03|0.0404
71819423|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.249||0.1352|TWO_SIDED|95.0|-0.87|0.12|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.87|0.1352
71819424|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.121||0.0056|TWO_SIDED|95.0|0.1|0.58|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.10|0.0056
71819425|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1537|TWO_SIDED|95.0|-0.06|0.4|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.40|-0.06|0.1537
71819426|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.129||0.0142|TWO_SIDED|95.0|0.07|0.58|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.58|0.07|0.0142
71819427|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.31|STANDARD_ERROR_OF_MEAN|0.126||0.0159|TWO_SIDED|95.0|0.06|0.56|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.56|0.06|0.0159
71819428|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.132||0.2255|TWO_SIDED|95.0|-0.1|0.42|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.42|-0.10|0.2255
71819429|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.129||0.1069|TWO_SIDED|95.0|-0.05|0.46|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.05|0.1069
71819430|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.4932|TWO_SIDED|95.0|-0.19|0.39|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.19|0.4932
71901483|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|40.2|||||TWO_SIDED|95.0|15.16|106.65|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6A||106.65|15.16|
71901484|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|20.38|||||TWO_SIDED|95.0|8.39|49.51|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 6B||49.51|8.39|
71819431|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.14||0.2634|TWO_SIDED|95.0|-0.12|0.43|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.43|-0.12|0.2634
71819432|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.133||0.9284|TWO_SIDED|95.0|-0.25|0.28|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.25|0.9284
71819433|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9459|TWO_SIDED|95.0|-0.25|0.26|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.25|0.9459
71819434|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2908|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2908
71901485|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|21.22|||||TWO_SIDED|95.0|8.65|52.07|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 7F||52.07|8.65|
71679648|NCT02612610|142877103|OTHER||LS Mean Difference|-0.8||||0.0155|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0155
71819435|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.146||0.6834|TWO_SIDED|95.0|-0.23|0.35|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.23|0.6834
71819436|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.142||0.3579|TWO_SIDED|95.0|-0.41|0.15|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.41|0.3579
71819437|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.138||0.827|TWO_SIDED|95.0|-0.3|0.24|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.30|0.8270
71819438|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.5292|TWO_SIDED|95.0|-0.34|0.18|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.34|0.5292
71819439|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.127||0.879|TWO_SIDED|95.0|-0.23|0.27|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.23|0.8790
71819440|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.133||0.1347|TWO_SIDED|95.0|-0.46|0.06|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.46|0.1347
71901486|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|23.73|||||TWO_SIDED|95.0|10.39|54.19|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 9V||54.19|10.39|
71901487|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.84|||||TWO_SIDED|95.0|5.46|30.22|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 14||30.22|5.46|
71901488|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|12.88|||||TWO_SIDED|95.0|5.95|27.88|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 18C||27.88|5.95|
71901489|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|26.99|||||TWO_SIDED|95.0|11.46|63.58|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19A||63.58|11.46|
71901490|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|15.53|||||TWO_SIDED|95.0|7.02|34.38|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 19F||34.38|7.02|
71901491|NCT05372575|143324929|SUPERIORITY|The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student's t distribution.|GMR|48.73|||||TWO_SIDED|95.0|18.67|127.16|||||GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)|GMR of 13vPnC Cohort/non-13vPnC Cohort in VT- or Sp- Subgroups for Serotype: 23F||127.16|18.67|
71819441|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.129||0.2874|TWO_SIDED|95.0|-0.4|0.12|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.40|0.2874
71819442|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.0086|TWO_SIDED|95.0|-0.61|-0.09|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.61|0.0086
71819443|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.129||0.7864|TWO_SIDED|95.0|-0.29|0.22|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.29|0.7864
71819444|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.172||0.4383|TWO_SIDED|95.0|-0.48|0.21|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.48|0.4383
71819445|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.167||0.8767|TWO_SIDED|95.0|-0.36|0.31|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.36|0.8767
71819446|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.153||0.0341|TWO_SIDED|95.0|-0.63|-0.03|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.63|0.0341
71819447|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.147||0.5629|TWO_SIDED|95.0|-0.38|0.21|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.38|0.5629
71819448|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.129||0.0016|TWO_SIDED|95.0|-0.67|-0.16|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.16|-0.67|0.0016
71850960|NCT01180400|143216027|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.201|TWO_SIDED|95.0|-0.98|0.21||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.21|-0.98|0.201
71850961|NCT01180400|143216028|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.756|TWO_SIDED|95.0|-0.62|0.45|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.45|-0.62|0.756
71850962|NCT01180400|143216029|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.62|TWO_SIDED|95.0|-0.4|0.68|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.68|-0.40|0.620
71819449|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.126||0.0495|TWO_SIDED|95.0|-0.5|0.0|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.50|0.0495
71819450|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.155||0.7177|TWO_SIDED|95.0|-0.36|0.25|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.36|0.7177
71850963|NCT01180400|143216030|SUPERIORITY_OR_OTHER||LS mean|0.15|STANDARD_ERROR_OF_MEAN|1.592||0.924|TWO_SIDED|95.0|-2.981|3.286|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||3.286|-2.981|0.924
71850964|NCT01180400|143216031|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.345|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.10|-0.30|0.345
71850965|NCT01180400|143216032|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.942|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.19|-0.20|0.942
71850966|NCT01180400|143216033|SUPERIORITY_OR_OTHER||LS mean|-0.011|STANDARD_ERROR_OF_MEAN|0.0198||0.576|TWO_SIDED|95.0|-0.05|0.0279||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0279|-0.0500|0.576
71850967|NCT01180400|143216033|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|2.11||0.842|TWO_SIDED|95.0|-4.58|3.73||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||3.73|-4.58|0.842
71850968|NCT00248794|143216050|SUPERIORITY_OR_OTHER||||||<|0.97|||||||ANOVA|||||||<.97
71850969|NCT00248794|143216051|SUPERIORITY_OR_OTHER|||||||0.77|||||||ANOVA|||||||.77
71850970|NCT00237718|143216061|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71850971|NCT00237718|143216062|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71850972|NCT02432183|143216081|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||Kruskal-Wallis|post-hoc comparison with Dunn's multiple comparison test: p=0.0326 between arm 1 and 2; p=0.0147 between arm 1 and 3||||||0.0061
71850973|NCT01133678|143216103|OTHER|||||||0.19||||||A recommendation to stop the trial early was stipulated if the conditional power at the interim analysis (after 50 patients) was \<10% using a stochastic curtailment approach.. This would occur if the interim test statistic is t \< -0.287.|t-test, 2 sided|t-statistic = -1.330, exceeding threshold (\<-0.287, conditional power\<10%) for early termination.||||||0.190
71850974|NCT00424476|143216114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0006||95.0|1.3|2.59||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: \<2g vs ≥2g per 24hr; Race: African/indig-American vs Other)||||2.59|1.30|0.0006
71850975|NCT00424476|143216114|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.0129|TWO_SIDED|95.0|1.1|2.19||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).|Regression, Logistic|Adjusted for baseline stratification factors.||||2.19|1.10|0.0129
71850976|NCT00424476|143216115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.0024|TWO_SIDED|95.0|1.21|2.41|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.41|1.21|0.0024
71819451|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.151||0.9401|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9401
71819452|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.147||0.3201|TWO_SIDED|95.0|-0.44|0.15|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.44|0.3201
71819453|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.144||0.8286|TWO_SIDED|95.0|-0.25|0.32|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.25|0.8286
71819454|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.162||0.3022|TWO_SIDED|95.0|-0.49|0.15|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.49|0.3022
71819455|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.158||0.8022|TWO_SIDED|95.0|-0.35|0.27|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.35|0.8022
71819456|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.165||0.5665|TWO_SIDED|95.0|-0.42|0.23|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.42|0.5665
71819457|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.161||0.817|TWO_SIDED|95.0|-0.36|0.28|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.36|0.8170
71819458|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.155||0.0404|TWO_SIDED|95.0|-0.63|-0.01|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.63|0.0404
71819459|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3128|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3128
71819460|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.162||0.24|TWO_SIDED|95.0|-0.51|0.13|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.51|0.2400
71819461|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.157||0.484|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4840
71850977|NCT00424476|143216115|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0189|TWO_SIDED|95.0|1.07|2.14|||Regression, Logistic|Adjusted for baseline stratification factors.||||2.14|1.07|0.0189
71850978|NCT00424476|143216116|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.0003
71850979|NCT00424476|143216116|SUPERIORITY_OR_OTHER|||||||0.2712||95.0|||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.||||||0.2712
71819462|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.141||0.7768|TWO_SIDED|95.0|-0.32|0.24|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.32|0.7768
71819463|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.137||0.7713|TWO_SIDED|95.0|-0.31|0.23|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.31|0.7713
71819464|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.151||0.0716|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0716
71819465|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.148||0.4317|TWO_SIDED|95.0|-0.41|0.18|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.41|0.4317
71850980|NCT00424476|143216117|SUPERIORITY_OR_OTHER|||||||0.887|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8870
71850981|NCT00424476|143216117|SUPERIORITY_OR_OTHER|||||||0.8127|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.||||||0.8127
71850982|NCT00424476|143216118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0526|TWO_SIDED|95.0|0.99|3.08|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.08|0.99|0.0526
71901492|NCT01544595|143324933|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.42|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.42|0.22|<0.0001
71901493|NCT01544595|143324933|SUPERIORITY|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.2|||<|0.0001|TWO_SIDED|95.0|0.14|0.29|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~* H1: p1(t) - p0,1(t) = 0 versus HA1: p1(t)- p0,1(t) ≥ 0,~* H2: p2(t) - p0,2(t) = 0 versus HA2: p2(t) - p0,2(t) ≥ 0,"||0.29|0.14|<0.0001
71819466|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.162||0.2115|TWO_SIDED|95.0|-0.52|0.12|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.52|0.2115
71850983|NCT00424476|143216118|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0252|TWO_SIDED|95.0|1.08|3.31|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.||||3.31|1.08|0.0252
71850984|NCT01280656|143216134|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
71850985|NCT01280656|143216135|SUPERIORITY_OR_OTHER|||||||0.693|||||||Chi-squared|||||||0.693
71850986|NCT01280656|143216137|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Chi-squared|||||||0.573
71850987|NCT01280656|143216139|SUPERIORITY_OR_OTHER|||||||0.982|TWO_SIDED||||||Chi-squared|||Mean at the site||||0.982
71850988|NCT01280656|143216139|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Chi-squared|||Mean at home||||0.012
71850989|NCT01280656|143216140|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Responders vs Non-responders||||0.476
71850990|NCT01280656|143216140|SUPERIORITY_OR_OTHER|||||||0.32|||||||t-test, 2 sided|||Responders vs Non-Responders||||0.320
71850991|NCT01280656|143216141|SUPERIORITY_OR_OTHER|||||||0.792|TWO_SIDED||||||Chi-squared|||||||0.792
71850992|NCT01280656|143216142|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
71850993|NCT01280656|143216143|SUPERIORITY_OR_OTHER|||||||0.921|TWO_SIDED||||||Chi-squared|||||||0.921
71850994|NCT01280656|143216144|SUPERIORITY_OR_OTHER|||||||0.202|TWO_SIDED||||||Chi-squared|||||||0.202
71850995|NCT01280656|143216145|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||Chi-squared|||Total||||0.973
71883030|NCT00930761|143285240|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.22||||0.06||95.0|0.99|1.51|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.51|0.99|0.06
71883031|NCT00930761|143285241|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.13||95.0|0.73|5.66|||Chi-squared|||||5.66|0.73|0.13
71901494|NCT02492750|143324955|OTHER||Maximum Tolerated Dose (MTD) Level|3.0|||||TWO_SIDED||||||||MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.|||||
71679649|NCT02612610|142877104|OTHER||LS Mean Difference|-0.4||||0.2458|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2458
71679650|NCT02612610|142877104|OTHER||LS Mean Difference|-0.6||||0.0662|TWO_SIDED|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.2|0.0662
71679651|NCT02612610|142877104|OTHER||LS Mean Difference|-0.7||||0.0197|TWO_SIDED|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.1|-1.4|0.0197
71679652|NCT02612610|142877105|OTHER||LS Mean Difference|0.3||||0.1921|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.1921
71679653|NCT02612610|142877105|OTHER||LS Mean Difference|0.3||||0.2428|TWO_SIDED|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.2|0.2428
71679654|NCT02612610|142877105|OTHER||LS Mean Difference|-0.1||||0.7383|TWO_SIDED|95.0|-0.6|0.4|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.6|0.7383
71679655|NCT02612610|142877106|OTHER||LS Mean Difference|0.3||||0.4033|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4033
71679656|NCT02612610|142877106|OTHER||LS Mean Difference|0.2||||0.4599|TWO_SIDED|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.9|-0.4|0.4599
71679657|NCT02612610|142877106|OTHER||LS Mean Difference|-0.3||||0.2837|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.2837
71819467|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.158||0.2818|TWO_SIDED|95.0|-0.48|0.14|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.48|0.2818
71850996|NCT01574105|143216150|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes of 26 in heparin resistant group and 26 in heparin sensitive group achieve 90% power at the 0.025 level of significance to detect a non-inferiority using a one-sided two-sample t-test, assuming a noninferiority margin is 200 milliliters in the postoperative chest tube loss.|||||<|0.1||95.0|||||ANCOVA|||For the analysis of the patient characteristics Wilcoxon, Chi-square and Fischer's exact tests were used. An upper bound of a two-sided 95% confidence interval (CI) of the mean difference between resistant and sensitive groups for all values of chest tube losses was computed by analysis of covariance (ANCOVA), and compared with pre-specified noninferiority limits. Covariates in the ANCOVA model included patient characteristics differing between two groups with a p-value \<0.1.||||<0.1
71679658|NCT02612610|142877107|OTHER||LS Mean Difference|0.1||||0.8084|TWO_SIDED|95.0|-0.6|0.8|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.8|-0.6|0.8084
71679659|NCT02612610|142877107|OTHER||LS Mean Difference|-0.2||||0.6108|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6108
71679660|NCT02612610|142877107|OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4220
71679661|NCT02612610|142877108|OTHER||LS Mean Difference|-0.1||||0.8457|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.8457
71679662|NCT02612610|142877108|OTHER||LS Mean Difference|-0.3||||0.4044|TWO_SIDED|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-0.9|0.4044
71679663|NCT02612610|142877108|OTHER||LS Mean Difference|-0.3||||0.3031|TWO_SIDED|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.0|0.3031
71679664|NCT02612610|142877109|OTHER||LS Mean Difference|0.0||||0.9126|TWO_SIDED|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.7|0.9126
71679665|NCT02612610|142877109|OTHER||LS Mean Difference|-0.5||||0.1136|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.1136
71679666|NCT02612610|142877109|OTHER||LS Mean Difference|-0.7||||0.0352|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||-0.0|-1.4|0.0352
71679667|NCT02612610|142877110|OTHER||LS Mean Difference|-0.5||||0.1718|TWO_SIDED|95.0|-1.1|0.2|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.1|0.1718
71679668|NCT02612610|142877110|OTHER||LS Mean Difference|-0.6||||0.0651|TWO_SIDED|95.0|-1.3|0.0|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.3|0.0651
71679669|NCT02612610|142877110|OTHER||LS Mean Difference|-0.6||||0.0848|TWO_SIDED|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.2|0.0848
71819468|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.14||0.2018|TWO_SIDED|95.0|-0.46|0.1|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.46|0.2018
71850997|NCT00608959|143216152|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91|STANDARD_DEVIATION|1.563|<|0.001||95.0|-2.55|-1.26|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.26|-2.55|<0.001
71679670|NCT02612610|142877111|OTHER||LS Mean Difference|-0.1||||0.6715|TWO_SIDED|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.8|0.6715
71679671|NCT02612610|142877111|OTHER||LS Mean Difference|-0.3||||0.3514|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3514
71679672|NCT02612610|142877111|OTHER||LS Mean Difference|-0.4||||0.2809|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2809
71819469|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.137||0.6554|TWO_SIDED|95.0|-0.33|0.21|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.33|0.6554
71819470|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.168||0.4754|TWO_SIDED|95.0|-0.21|0.46|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.46|-0.21|0.4754
71901495|NCT04415489|143324990|SUPERIORITY|||||||0.57||||||The a priori threshold for statistical significance was p \< 0.05.|Fisher Exact|||||||0.57
71819471|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.163||0.7776|TWO_SIDED|95.0|-0.28|0.37|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.28|0.7776
71850998|NCT00608959|143216152|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.87|STANDARD_DEVIATION|1.656|<|0.001||95.0|-2.57|-1.17|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.||-1.17|-2.57|<0.001
71819472|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.213||0.7172|TWO_SIDED|95.0|-0.5|0.35|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.50|0.7172
71819473|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.203||0.4791|TWO_SIDED|95.0|-0.55|0.26|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.55|0.4791
71850999|NCT04351243|143216155|SUPERIORITY||Risk Difference (RD)|0.05||||0.1885|TWO_SIDED|95.0|-0.06|0.17||one-sided p value|Mantel Haenszel|||||0.17|-0.06|0.1885
71851000|NCT01248715|143216165|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||.460
71851001|NCT01248715|143216166|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
71851002|NCT01248715|143216167|SUPERIORITY|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||.732
71901496|NCT04415489|143324991|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was p \< 0.05.|t-test, 2 sided|||||||<0.01
71851003|NCT01248715|143216168|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
71851004|NCT01248715|143216169|SUPERIORITY|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
71851005|NCT01248715|143216170|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||.796
71851006|NCT01248715|143216171|SUPERIORITY|||||||0.9999|||||||Wilcoxon (Mann-Whitney)|||||||.9999
71851007|NCT01215253|143216207|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.117|TWO_SIDED|95.0|0.67|1.05|||Regression, Cox|||||1.05|0.67|0.117
71851008|NCT01215253|143216208|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.891|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox|||||1.26|0.76|0.891
71851009|NCT01215253|143216209|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.028|TWO_SIDED|95.0|0.51|0.96|||Anderson-Gill analysis|||||0.96|0.51|0.028
71851010|NCT01215253|143216210|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.398|TWO_SIDED|95.0|0.38|1.47|||Regression, Cox|||||1.47|0.38|0.398
71851011|NCT01215253|143216211|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.316|TWO_SIDED|95.0|0.91|1.34|||Regression, Cox|||||1.34|0.91|0.316
71851012|NCT01215253|143216212|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.577|TWO_SIDED|95.0|0.84|1.37|||Regression, Cox|||||1.37|0.84|0.577
71851013|NCT01215253|143216213|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.871|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.871
71851014|NCT01215253|143216214|SUPERIORITY|||||||0.508|||||||nonparametric Wilcoxon rank-sum test|||||||0.508
71851015|NCT01215253|143216215|SUPERIORITY|||||||0.948|||||||nonparametric Wilcoxon rank-sum test|||||||0.948
71851016|NCT01215253|143216216|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.038|TWO_SIDED|95.0|0.55|0.98|||Regression, Cox|||||0.98|0.55|0.038
71851017|NCT01215253|143216217|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.947|TWO_SIDED|95.0|0.73|1.41|||Regression, Cox|||||1.41|0.73|0.947
71851018|NCT01215253|143216218|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.414|TWO_SIDED|95.0|0.36|1.52|||Anderdon-Gill analysis|||||1.52|0.36|0.414
71851019|NCT03512041|143216219|SUPERIORITY|||||||0.172|||||||ANOVA|||||||0.172
71851020|NCT03512041|143216220|SUPERIORITY|||||||0.169|||||||ANOVA|||||||0.169
71851021|NCT03512041|143216221|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
71851022|NCT00828139|143216222|SUPERIORITY_OR_OTHER||3-month PFS|0.24|||||TWO_SIDED|90.0|0.14|0.37|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier. The 3-month PFS estimated value corresponds to the probability of PFS at month 3.||0.37|0.14|
71851023|NCT00828139|143216222|SUPERIORITY_OR_OTHER||3-month PFS|0.15|||||TWO_SIDED|90.0|0.07|0.27|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.27|0.07|
71851024|NCT00828139|143216222|SUPERIORITY_OR_OTHER||3-month PFS|0.27|||||TWO_SIDED|90.0|0.18|0.39|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.39|0.18|
71851025|NCT00828139|143216222|SUPERIORITY_OR_OTHER||3-month PFS|0.1|||||TWO_SIDED|90.0|0.04|0.2|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.||0.2|0.04|
71851026|NCT00828139|143216222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|90.0|0.91|1.92||||||Hazard Ratio was evaluated using a logrank test.||1.92|0.91|
71901497|NCT04415489|143324992|SUPERIORITY|||||||0.11||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.11
71901498|NCT04415489|143324993|SUPERIORITY|||||||0.16||||||The a priori threshold for statistical significance was \< 0.05.|t-test, 2 sided|||||||0.16
71901499|NCT04415489|143324994|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||< 0.01
71901500|NCT04415489|143324998|SUPERIORITY|||||||0.12||||||The a priori threshold for statistical significance was \< 0.05.|Fisher Exact|||||||0.12
71819474|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.164||0.3562|TWO_SIDED|95.0|-0.48|0.17|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.48|0.3562
71819475|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.162||0.8859|TWO_SIDED|95.0|-0.3|0.34|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.30|0.8859
71819476|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.192||0.5888|TWO_SIDED|95.0|-0.49|0.28|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.49|0.5888
71851027|NCT00828139|143216222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||||TWO_SIDED|90.0|1.08|2.1||||||Hazard Ratio was evaluated using log-rank test.||2.10|1.08|
71679673|NCT02612610|142877112|OTHER||LS Mean Difference|-0.2||||0.6022|TWO_SIDED|95.0|-0.9|0.5|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.5|-0.9|0.6022
71819477|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.187||0.3992|TWO_SIDED|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.53|0.3992
71819478|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.227||0.1212|TWO_SIDED|95.0|-0.8|0.1|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.80|0.1212
71819479|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.221||0.3185|TWO_SIDED|95.0|-0.66|0.22|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.66|0.3185
71819480|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.231||0.4809|TWO_SIDED|95.0|-0.62|0.29|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.62|0.4809
71819481|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.225||0.8953|TWO_SIDED|95.0|-0.42|0.48|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.48|-0.42|0.8953
71819482|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.223||0.5616|TWO_SIDED|95.0|-0.57|0.31|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.57|0.5616
71819483|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.216||0.8571|TWO_SIDED|95.0|-0.39|0.47|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.47|-0.39|0.8571
71851028|NCT00759681|143216228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.0538||0.05|TWO_SIDED|95.0|0.103|0.314|||Exact binomial confidence limit|Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.||Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.||0.314|0.103|0.05
71901501|NCT05319535|143325005|SUPERIORITY||Mean Difference (Final Values)|2.2||||0.26|TWO_SIDED|95.0|-1.8|6.1|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||6.1|-1.8|0.26
71901502|NCT05319535|143325006|SUPERIORITY||rate ratio|1.7||||0.11|TWO_SIDED|95.0|0.9|3.4|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||3.4|0.9|0.11
71901503|NCT05319535|143325007|SUPERIORITY||Mean Difference (Final Values)|37.6||||0.17|TWO_SIDED|95.0|-18.1|93.3|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||93.3|-18.1|0.17
71901504|NCT05319535|143325008|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1|TWO_SIDED|95.0|-0.1|1.4|||Regression, Linear|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||1.4|-0.1|0.10
71679674|NCT02612610|142877112|OTHER||LS Mean Difference|-0.3||||0.4456|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4456
71679675|NCT02612610|142877112|OTHER||LS Mean Difference|-0.3||||0.4629|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4629
71679676|NCT02612610|142877113|OTHER||LS Mean Difference|-0.3||||0.3749|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.3749
71679677|NCT02612610|142877113|OTHER||LS Mean Difference|-0.6||||0.0854|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0854
71679678|NCT02612610|142877113|OTHER||LS Mean Difference|-0.4||||0.2672|TWO_SIDED|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.3|-1.1|0.2672
71679679|NCT02612610|142877114|OTHER||LS Mean Difference|-0.1||||0.7255|TWO_SIDED|95.0|-0.8|0.6|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.6|-0.8|0.7255
71679680|NCT02612610|142877114|OTHER||LS Mean Difference|-0.6||||0.0918|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0918
71901505|NCT05319535|143325009|SUPERIORITY||rate ratio|1.3||||0.36|TWO_SIDED|95.0|0.7|2.3|||negative binomial regression|||Models included the arm indicator variable in addition to the stratification variables used in randomization (site complexity level (high complexity '1a', '1b' or '1c' vs. all others); prior implementation of Caregivers First (yes vs. no)).||2.3|0.7|0.36
71901506|NCT05319535|143325010|SUPERIORITY||Odds Ratio (OR)|3.3||||0.17|TWO_SIDED|95.0|0.6|18.5|||Regression, Logistic|||Model included the arm indicator variable.||18.5|0.6|0.17
71901507|NCT01064648|143325012|OTHER||Hazard Ratio (HR)|0.71||||0.06|TWO_SIDED|80.0|0.54|0.95||1-sided p-value|Log Rank|Stratified log rank test by performance status and histology type.||||0.95|0.54|0.06
71901508|NCT01064648|143325013|OTHER||Hazard Ratio (HR)|0.88||||0.28|TWO_SIDED|80.0|0.65|1.17||1-sided p-value|Log Rank|Stratified log-rank test by performance status and histology.||||1.17|0.65|0.28
71901509|NCT01064648|143325014|OTHER||Odds Ratio (OR)|1.85||||0.15|TWO_SIDED|95.0|0.59|5.83||1-sided p-value|Chi-squared|Stratified Chi-square by performance status and histology.||||5.83|0.59|0.15
71901510|NCT01064648|143325015|OTHER||Odds Ratio (OR)|0.45||||0.09|TWO_SIDED|95.0|0.14|1.49||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.49|0.14|0.09
71901511|NCT01064648|143325016|OTHER||Odds Ratio (OR)|4.3||||0.006|TWO_SIDED|95.0|1.4|13.3||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology.||||13.3|1.4|0.006
71901512|NCT01064648|143325017|OTHER||Odds Ratio (OR)|0.59||||0.19|TWO_SIDED|95.0|0.18|1.94||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology||||1.94|0.18|0.19
71901513|NCT01286272|143325030|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8457|TWO_SIDED|95.0|0.51|1.74|||Log Rank|||||1.74|0.51|0.8457
71901514|NCT02891798|143325035|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Total Score Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.003
71901515|NCT02891798|143325036|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Continuous Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.001
71901516|NCT02891798|143325037|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Comparison of SF-MPQ2 Intermittent Pain Subscore Difference From Baseline between the 4-drug nerve block group and the bupivacaine only group||||0.038
71679681|NCT02612610|142877114|OTHER||LS Mean Difference|-0.5||||0.1263|TWO_SIDED|95.0|-1.2|0.2|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.2|-1.2|0.1263
71819484|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.213||0.0037|TWO_SIDED|95.0|-1.05|-0.21|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.21|-1.05|0.0037
71819485|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.206||0.0386|TWO_SIDED|95.0|-0.84|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.84|0.0386
71819486|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.216||0.0044|TWO_SIDED|95.0|-1.05|-0.2|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-1.05|0.0044
71819487|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.208||0.8308|TWO_SIDED|95.0|-0.46|0.37|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.46|0.8308
71819488|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.215||0.0388|TWO_SIDED|95.0|-0.87|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.87|0.0388
71819489|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.209||0.1622|TWO_SIDED|95.0|-0.71|0.12|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.71|0.1622
71819490|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.204||0.0179|TWO_SIDED|95.0|-0.89|-0.09|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.09|-0.89|0.0179
71819491|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.198||0.4283|TWO_SIDED|95.0|-0.55|0.24|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.55|0.4283
71851029|NCT00759681|143216229|NON_INFERIORITY_OR_EQUIVALENCE|Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%.|Mean Difference (Final Values)|-0.135|STANDARD_ERROR_OF_MEAN|0.0671||0.05|ONE_SIDED|95.0||-0.003|||Exact binomial confidence limit|Safety: 95% confidence limits of the difference between groups, and ensuring that the upper limit of the difference was less than or equal to 15%.|The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.|The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.||-0.003||0.05
71679682|NCT02612610|142877115|OTHER||LS Mean Difference|-0.3||||0.4058|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4058
71819492|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.219||0.1899|TWO_SIDED|95.0|-0.72|0.15|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.72|0.1899
71851030|NCT00476151|143216230|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|95.0|||||ANCOVA|||||||0.083
71901517|NCT02891798|143325038|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at post-operative day 1 between the 4-drug nerve block group and the bupivacaine only group||||0.009
71819493|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.213||0.8022|TWO_SIDED|95.0|-0.48|0.37|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.48|0.8022
71819494|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.215||0.378|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3780
71819495|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.21||0.811|TWO_SIDED|95.0|-0.47|0.36|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.36|-0.47|0.8110
71819496|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.272||0.8908|TWO_SIDED|95.0|-0.58|0.5|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.50|-0.58|0.8908
71851031|NCT04332991|143216234|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.73|1.42|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group.|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.42|0.73|
71679683|NCT02612610|142877115|OTHER||LS Mean Difference|-0.6||||0.0828|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0828
71819497|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.263||0.3596|TWO_SIDED|95.0|-0.28|0.76|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.76|-0.28|0.3596
71819498|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.293||0.7617|TWO_SIDED|95.0|-0.67|0.49|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.49|-0.67|0.7617
71901518|NCT02891798|143325039|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the QoR-15 Total Score.||||||0.861|||||||t-test, 2 sided|||Comparison of QoR-15 Total Score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.861
71819499|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.281||0.5498|TWO_SIDED|95.0|-0.73|0.39|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.73|0.5498
71819500|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.235||0.2066|TWO_SIDED|95.0|-0.76|0.17|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.76|0.2066
71819501|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2321|TWO_SIDED|95.0|-0.73|0.18|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.73|0.2321
71901519|NCT02891798|143325040|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly lower score for the Standing Balance test.||||||0.512|||||||t-test, 2 sided|||Comparison of Standing Balance Test score at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group||||0.512
71901520|NCT02891798|143325041|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower rate for the Self-Selected Gait Speed test.||||||0.339|||||||t-test, 2 sided|||Comparison of Self-Selected Gait Speed rate at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.339
71819502|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.191||0.5582|TWO_SIDED|95.0|-0.49|0.27|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.49|0.5582
71679684|NCT02612610|142877115|OTHER||LS Mean Difference|-0.7||||0.0575|TWO_SIDED|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.0|-1.4|0.0575
71819503|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.186||0.2945|TWO_SIDED|95.0|-0.56|0.17|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.56|0.2945
71819504|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.208||0.2684|TWO_SIDED|95.0|-0.64|0.18|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.64|0.2684
71819505|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.202||0.9396|TWO_SIDED|95.0|-0.42|0.39|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.39|-0.42|0.9396
71851032|NCT04332991|143216235|SUPERIORITY||Odds Ratio (OR)|1.28|||||TWO_SIDED|95.0|0.9|1.81|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.81|0.90|
71851033|NCT04332991|143216236|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.84|
71851034|NCT04332991|143216237|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.38|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure is adjusted for : age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization.||1.38|0.69|
71901521|NCT02891798|143325042|NON_INFERIORITY|Testing the null hypothesis that Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone) does not adversely affect recovery by producing a significantly slower time for the Repeated Chair Stand test.||||||0.711|||||||t-test, 2 sided|||Comparison of Repeated Chair Stand time at 6 week post-procedure between the 4-drug nerve block group and the bupivacaine only group.||||0.711
71901522|NCT01953328|143325051|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-73.97|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-78.54|-69.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.41|-78.54|<0.001
71851035|NCT04332991|143216238|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.68|3.57|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.57|0.68|
71851036|NCT04332991|143216239|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.54|2.09|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.09|0.54|
71851037|NCT04332991|143216240|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.6|2.14|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.14|0.60|
71851038|NCT04332991|143216241|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.68|1.34|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.34|0.68|
71901523|NCT01953328|143325051|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.89|STANDARD_ERROR_OF_MEAN|2.18|<|0.001|TWO_SIDED|95.0|-77.22|-68.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.57|-77.22|<0.001
71819506|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.195||0.0283|TWO_SIDED|95.0|-0.82|-0.05|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.82|0.0283
71819507|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.189||0.1794|TWO_SIDED|95.0|-0.63|0.12|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.63|0.1794
71851039|NCT04332991|143216242|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.76|2.08|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||2.08|0.76|
71851040|NCT04332991|143216243|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.61|1.72|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.72|0.61|
71851041|NCT04332991|143216244|SUPERIORITY||Odds Ratio (OR)|1.26|||||TWO_SIDED|95.0|0.84|1.88|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.88|0.84|
71851042|NCT04332991|143216245|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.85|1.61|||||Odds ratios greater than 1.0 indicated more favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.61|0.85|
71851043|NCT04332991|143216246|SUPERIORITY||Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-1.0|1.8||||||||1.8|-1.0|
71901524|NCT01953328|143325051|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.41|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-81.21|-67.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-67.61|-81.21|<0.001
71819508|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.188||0.1091|TWO_SIDED|95.0|-0.68|0.07|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.68|0.1091
71851044|NCT04332991|143216247|SUPERIORITY||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.61|3.02|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.02|0.61|
71851045|NCT04332991|143216248|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
71851046|NCT04332991|143216249|SUPERIORITY||Odds Ratio (OR)|2.51|||||TWO_SIDED|95.0|0.78|8.12|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||8.12|0.78|
71851047|NCT04332991|143216250|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.45|1.05|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.05|0.45|
71851048|NCT04332991|143216251|SUPERIORITY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.24|2.7|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.70|0.24|
71851049|NCT04332991|143216252|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.59|1.59|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.59|0.59|
71851050|NCT04332991|143216253|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.3|1.58|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.58|0.30|
71851051|NCT04332991|143216254|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.48|3.18|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.18|0.48|
71851052|NCT04332991|143216255|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.24|3.96|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||3.96|0.24|
71851053|NCT04332991|143216256|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.73|1.53|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.53|0.73|
71851054|NCT04332991|143216257|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.92|1.89|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||1.89|0.92|
71851055|NCT04332991|143216258|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.21|2.94|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||2.94|0.21|
71851056|NCT04332991|143216259|SUPERIORITY||Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.06|15.74|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|||15.74|0.06|
71851057|NCT04332991|143216260|SUPERIORITY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.69|1.35|||||Odds ratios greater than 1.0 indicated less favorable outcomes for patients in the hydroxychloroquine group compared with the placebo group|Outcome measure was adjusted for: age, sex, baseline COVID Outcome Scale category, baseline Sequential Organ Failure Assessment score, and duration of acute respiratory infection symptoms prior to randomization||1.35|0.69|
71851058|NCT01129011|143216268|SUPERIORITY_OR_OTHER||proportions|11.9||||0.001|TWO_SIDED|95.0|7.9|17.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||17.1|7.9|0.001
71851059|NCT01129011|143216269|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71851060|NCT01129011|143216270|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||||||0.009
71851061|NCT01129011|143216271|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Cochran-Mantel-Haenszel|||||||0.007
71851062|NCT01129011|143216272|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71851063|NCT03745651|143216308|SUPERIORITY||Odds Ratio (OR)|8.84|||<|0.0001|TWO_SIDED|95.0|4.125|21.202||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||21.202|4.125|< 0.0001
71851064|NCT03745651|143216308|SUPERIORITY||Odds Ratio (OR)|15.8|||<|0.0001|TWO_SIDED|95.0|7.354|38.061||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||38.061|7.354|< 0.0001
71851065|NCT03745651|143216309|SUPERIORITY||Odds Ratio (OR)|6.84|||<|0.0001|TWO_SIDED|95.0|3.723|13.184||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||13.184|3.723|< 0.0001
71851066|NCT03745651|143216309|SUPERIORITY||Odds Ratio (OR)|10.67|||<|0.0001|TWO_SIDED|95.0|5.775|20.732||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||20.732|5.775|< 0.0001
71851067|NCT03745651|143216310|SUPERIORITY||Odds Ratio (OR)|4.17|||<|0.0001|TWO_SIDED|95.0|2.045|9.036||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||9.036|2.045|< 0.0001
71851068|NCT03745651|143216310|SUPERIORITY||Odds Ratio (OR)|5.8|||<|0.0001|TWO_SIDED|95.0|2.833|12.657||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||12.657|2.833|< 0.0001
71851069|NCT03745651|143216311|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8553|TWO_SIDED|95.0|0.598|2.094||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.094|0.598|0.8553
71851070|NCT03745651|143216311|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2359|TWO_SIDED|95.0|0.805|2.741||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||2.741|0.805|0.2359
71851071|NCT03745651|143216312|SUPERIORITY||Odds Ratio (OR)|1.62||||0.1784|TWO_SIDED|95.0|0.827|3.342||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||3.342|0.827|0.1784
71851072|NCT03745651|143216312|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0472|TWO_SIDED|95.0|1.007|4.0||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||||4.000|1.007|0.0472
71851073|NCT03745651|143216322|SUPERIORITY||Least Squares Mean Difference|-31.91|STANDARD_ERROR_OF_MEAN|4.92|<|0.0001|TWO_SIDED|95.0|-41.57|-22.25|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-22.25|-41.57|<0.0001
71851074|NCT03745651|143216322|SUPERIORITY||Least Squares Mean Difference|-35.13|STANDARD_ERROR_OF_MEAN|4.93|<|0.0001|TWO_SIDED|95.0|-44.81|-25.44|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 2||-25.44|-44.81|<0.0001
71819509|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.182||0.7921|TWO_SIDED|95.0|-0.41|0.31|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.41|0.7921
71819510|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.166||0.0055|TWO_SIDED|95.0|-0.8|-0.14|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.80|0.0055
71819511|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.161||0.03|TWO_SIDED|95.0|-0.67|-0.03|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.03|-0.67|0.0300
71819512|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.185||0.0118|TWO_SIDED|95.0|-0.84|-0.11|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.11|-0.84|0.0118
71819513|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.178||0.2266|TWO_SIDED|95.0|-0.57|0.14|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.57|0.2266
71819514|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.0025|TWO_SIDED|95.0|-0.92|-0.2|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.20|-0.92|0.0025
71819515|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.176||0.0555|TWO_SIDED|95.0|-0.69|0.01|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.69|0.0555
71819516|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.176||0.0013|TWO_SIDED|95.0|-0.93|-0.23|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.23|-0.93|0.0013
71819517|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.171||0.0775|TWO_SIDED|95.0|-0.64|0.03|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.64|0.0775
71819518|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.19||0.0006|TWO_SIDED|95.0|-1.05|-0.3|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.30|-1.05|0.0006
71819519|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0415|TWO_SIDED|95.0|-0.75|-0.01|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.75|0.0415
71851075|NCT03745651|143216322|SUPERIORITY||Least Squares Mean Difference|-44.56|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-53.19|-35.92|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-35.92|-53.19|<0.0001
71901525|NCT01953328|143325051|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.27|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-78.93|-69.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.60|-78.93|<0.001
71901526|NCT01953328|143325052|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-74.85|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-80.22|-69.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-69.47|-80.22|<0.001
71901527|NCT01953328|143325052|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.91|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|-74.6|-65.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.23|-74.60|<0.001
71901528|NCT01953328|143325052|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-78.85|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-83.55|-68.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-68.15|-83.55|<0.001
71901529|NCT01953328|143325052|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.87|STANDARD_ERROR_OF_MEAN|3.03|<|0.001|TWO_SIDED|95.0|-72.88|-60.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.87|-72.88|<0.001
71901530|NCT01953328|143325053|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-89.3|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-98.4|-80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.2|-98.4|<0.001
71901531|NCT01953328|143325053|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-86.3|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-95.1|-77.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-77.5|-95.1|<0.001
71901532|NCT01953328|143325053|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.7|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-75.3|-62.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.1|-75.3|<0.001
71901533|NCT01953328|143325053|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-72.0|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-79.5|-64.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.6|-79.5|<0.001
71901534|NCT01953328|143325054|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-90.8|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-100.9|-80.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-80.7|-100.9|<0.001
71901535|NCT01953328|143325054|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.5|-74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-74.8|-92.5|<0.001
71901536|NCT01953328|143325054|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-69.6|STANDARD_ERROR_OF_MEAN|3.5|<|0.001|TWO_SIDED|95.0|-76.5|-62.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.6|-76.5|<0.001
71901537|NCT01953328|143325054|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|4.2|<|0.001|TWO_SIDED|95.0|-73.8|-57.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-57.1|-73.8|<0.001
71819520|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.193||0.0581|TWO_SIDED|95.0|-0.75|0.01|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.75|0.0581
71819521|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.188||0.6826|TWO_SIDED|95.0|-0.45|0.3|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.45|0.6826
71819522|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.226||0.0912|TWO_SIDED|95.0|-0.83|0.06|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.83|0.0912
71819523|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3988|TWO_SIDED|95.0|-0.62|0.25|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.62|0.3988
71851076|NCT03745651|143216322|SUPERIORITY||Least Squares Mean Difference|-45.91|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001|TWO_SIDED|95.0|-54.55|-37.26|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 4||-37.26|-54.55|<0.0001
71851077|NCT03745651|143216322|SUPERIORITY||Least Squares Mean Difference|-44.53|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|-53.08|-35.98|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-35.98|-53.08|<0.0001
71901538|NCT01953328|143325055|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.67|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-73.06|-64.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-64.27|-73.06|<0.001
71819524|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.231||0.0504|TWO_SIDED|95.0|-0.91|0.0|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.91|0.0504
71819525|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.22||0.6019|TWO_SIDED|95.0|-0.55|0.32|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.55|0.6019
71851078|NCT03745651|143216322|SUPERIORITY||Least Squares Mean Difference|-46.0|STANDARD_ERROR_OF_MEAN|4.33|<|0.0001|TWO_SIDED|95.0|-54.51|-37.48|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Percent change from Baseline in EASI score at Week 8||-37.48|-54.51|<0.0001
71851079|NCT03745651|143216323|SUPERIORITY||Least Squares Mean Difference|-39.4|STANDARD_ERROR_OF_MEAN|3.59|<|0.0001|TWO_SIDED|95.0|-46.48|-32.38|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-32.38|-46.48|<0.0001
71851080|NCT03745651|143216323|SUPERIORITY||Least Squares Mean Difference|-43.5|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-50.51|-36.53|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent change from Baseline in SCORAD score at Week 8||-36.53|-50.51|<0.0001
71851081|NCT03745651|143216324|SUPERIORITY||Least Squares Mean Difference|-1.52|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.02|-1.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.01|-2.02|<0.0001
71851082|NCT03745651|143216324|SUPERIORITY||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.24|-1.24|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 2||-1.24|-2.24|<0.0001
71901539|NCT01953328|143325055|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.95|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-69.74|-62.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.16|-69.74|<0.001
71901540|NCT01953328|143325055|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.14|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-73.3|-62.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.99|-73.30|<0.001
71819526|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.222||0.007|TWO_SIDED|95.0|-1.05|-0.17|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.17|-1.05|0.0070
71851083|NCT03745651|143216324|SUPERIORITY||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.36|-1.23|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.23|-2.36|<0.0001
71851084|NCT03745651|143216324|SUPERIORITY||Least Squares Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.53|-1.4|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 4||-1.40|-2.53|<0.0001
71851085|NCT03745651|143216324|SUPERIORITY||Least Squares Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|0.31|<|0.0001|TWO_SIDED|95.0|-2.49|-1.29|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.29|-2.49|<0.0001
71851086|NCT03745651|143216324|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in Itch NRS score at Week 8||-1.10|-2.30|<0.0001
71851087|NCT03745651|143216326|SUPERIORITY||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.94|-0.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.97|-1.94|<0.0001
71851088|NCT03745651|143216326|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.72|-0.76|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in Skin Pain NRS score at Week 8||-0.76|-1.72|<0.0001
71819527|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.218||0.3785|TWO_SIDED|95.0|-0.62|0.24|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.62|0.3785
71851089|NCT03745651|143216329|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2903|TWO_SIDED|95.0|-1.71|0.51|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.51|-1.71|0.2903
71851090|NCT03745651|143216329|SUPERIORITY||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.57||0.0837|TWO_SIDED|95.0|-2.09|0.13|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 2||0.13|-2.09|0.0837
71901541|NCT01953328|143325055|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.28|STANDARD_ERROR_OF_MEAN|1.94|<|0.001|TWO_SIDED|95.0|-71.14|-63.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.42|-71.14|<0.001
71851091|NCT03745651|143216329|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6272|TWO_SIDED|95.0|-1.5|0.91|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.91|-1.50|0.6272
71851092|NCT03745651|143216329|SUPERIORITY||Least Squares Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.61||0.1609|TWO_SIDED|95.0|-2.07|0.34|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 4||0.34|-2.07|0.1609
71851093|NCT03745651|143216329|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.73||0.3362|TWO_SIDED|95.0|-2.13|0.73|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.73|-2.13|0.3362
71851094|NCT03745651|143216329|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.269|TWO_SIDED|95.0|-2.23|0.62|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form-Sleep Disturbance (8b) 24-hour recall score at Week 8||0.62|-2.23|0.2690
71851095|NCT03745651|143216330|SUPERIORITY||Least Squares Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.54||0.0482|TWO_SIDED|95.0|-2.13|-0.01|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.01|-2.13|0.0482
71851096|NCT03745651|143216330|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54||0.0271|TWO_SIDED|95.0|-2.26|-0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 2||-0.14|-2.26|0.0271
71679685|NCT02612610|142877116|OTHER||LS Mean Difference|-0.3||||0.4163|TWO_SIDED|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.4|-1.0|0.4163
71679686|NCT02612610|142877116|OTHER||LS Mean Difference|-0.6||||0.0882|TWO_SIDED|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.3|0.0882
71679687|NCT02612610|142877116|OTHER||LS Mean Difference|-0.6||||0.0961|TWO_SIDED|95.0|-1.4|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||0.1|-1.4|0.0961
71679688|NCT02612610|142877117|OTHER||LS Mean Difference|0.8||||0.163|TWO_SIDED|95.0|-0.3|1.9|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.9|-0.3|0.1630
71679689|NCT02612610|142877117|OTHER||LS Mean Difference|0.2||||0.7601|TWO_SIDED|95.0|-1.0|1.3|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||1.3|-1.0|0.7601
71679690|NCT02612610|142877117|OTHER||LS Mean Difference|2.1||||0.0004|TWO_SIDED|95.0|0.9|3.2|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.2|0.9|0.0004
71679691|NCT02612610|142877118|OTHER||LS Mean Difference|1.0||||0.0941|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0941
71819528|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.159||0.9609|TWO_SIDED|95.0|-0.32|0.31|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.32|0.9609
71819529|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.154||0.9183|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9183
71819530|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.149||0.071|TWO_SIDED|95.0|-0.57|0.02|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.57|0.0710
71819531|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.143||0.2607|TWO_SIDED|95.0|-0.45|0.12|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.45|0.2607
71679692|NCT02612610|142877118|OTHER||LS Mean Difference|0.9||||0.1321|TWO_SIDED|95.0|-0.3|2.2|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.2|-0.3|0.1321
71679693|NCT02612610|142877118|OTHER||LS Mean Difference|1.5||||0.0192|TWO_SIDED|95.0|0.2|2.7|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.7|0.2|0.0192
71679694|NCT02612610|142877119|OTHER||LS Mean Difference|1.2||||0.0626|TWO_SIDED|95.0|-0.1|2.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.4|-0.1|0.0626
71679695|NCT02612610|142877119|OTHER||LS Mean Difference|1.0||||0.0967|TWO_SIDED|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||2.3|-0.2|0.0967
71679696|NCT02612610|142877119|OTHER||LS Mean Difference|1.9||||0.0028|TWO_SIDED|95.0|0.7|3.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."||3.1|0.7|0.0028
71679697|NCT02612610|142877120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3182|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.3182
71679698|NCT02612610|142877120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5021|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.5021
71679699|NCT02612610|142877120|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0665|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0665
71679700|NCT02612610|142877121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0872|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0872
71679701|NCT02612610|142877121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0994|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0994
71819532|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.158||0.2466|TWO_SIDED|95.0|-0.5|0.13|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.50|0.2466
71901542|NCT01953328|143325056|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.93|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-73.96|-63.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.89|-73.96|<0.001
71679702|NCT02612610|142877121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0009
71679703|NCT02612610|142877122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0037
71679704|NCT02612610|142877122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0166
71679705|NCT02612610|142877122|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||<0.0001
71679706|NCT02612610|142877123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0396|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0396
71679707|NCT02612610|142877123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0751|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0751
71679708|NCT02612610|142877123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."||||0.0010
71679709|NCT02612610|142877124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test."||||0.8464
71679710|NCT02612610|142877124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7687|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7687
71679711|NCT02612610|142877124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4364|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.4364
71679712|NCT02612610|142877125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9966|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.9966
71819533|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.153||0.3461|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3461
71851097|NCT03745651|143216330|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.6||0.2091|TWO_SIDED|95.0|-1.94|0.42|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||0.42|-1.94|0.2091
71851098|NCT03745651|143216330|SUPERIORITY||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.6||0.0111|TWO_SIDED|95.0|-2.71|-0.35|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 4||-0.35|-2.71|0.0111
71851099|NCT03745651|143216330|SUPERIORITY||Least Squares Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.68||0.0802|TWO_SIDED|95.0|-2.51|0.14|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.14|-2.51|0.0802
71851100|NCT03745651|143216330|SUPERIORITY||Least Squares Mean Difference|-1.24|STANDARD_ERROR_OF_MEAN|0.67||0.0666|TWO_SIDED|95.0|-2.56|0.09|||Mixed-Model with Repeated Measures|The MMRM included the fixed effect of treatment, stratification factor, the visit, and treatment by visit interaction.||Change from Baseline in PROMIS Short Form - Sleep-Related Impairment (8a) 24-hour recall score at Week 8||0.09|-2.56|0.0666
71851101|NCT03745651|143216333|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.84|-2.97|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-2.97|-4.84|<0.0001
71851102|NCT03745651|143216333|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-5.47|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in %BSA at Week 8||-3.63|-5.47|<0.0001
71851103|NCT03745651|143216335|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.38|-4.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.86|-7.38|<0.0001
71901543|NCT01953328|143325056|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.58|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-67.96|-59.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.21|-67.96|<0.001
71679713|NCT02612610|142877125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6372|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6372
71679714|NCT02612610|142877125|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2155|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2155
71851104|NCT03745651|143216335|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|0.64|<|0.0001|TWO_SIDED|95.0|-7.17|-4.67|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in POEM score at Week 8||-4.67|-7.17|<0.0001
71851105|NCT03745651|143216337|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.48|<|0.0001|TWO_SIDED|95.0|-4.19|-2.32|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-2.32|-4.19|<0.0001
71851106|NCT03745651|143216337|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-3.67|-1.83|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total DLQI score at Week 8||-1.83|-3.67|<0.0001
71851107|NCT03745651|143216339|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.55||0.0099|TWO_SIDED|95.0|-7.24|-1.03|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||-1.03|-7.24|0.0099
71851108|NCT03745651|143216339|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.59||0.0542|TWO_SIDED|95.0|-6.3|0.06|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in total CDLQI score at Week 8||0.06|-6.30|0.0542
71851109|NCT03745651|143216343|SUPERIORITY||Odds Ratio (OR)|5.16|||<|0.0001|TWO_SIDED|95.0|2.987|9.049||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||9.049|2.987|<0.0001
71851110|NCT03745651|143216343|SUPERIORITY||Odds Ratio (OR)|7.47|||<|0.0001|TWO_SIDED|95.0|4.23|13.415||The unadjusted p-values between each treatment group and vehicle were calculated based on Exact Logistic Regression including treatment and stratification factors to test the treatment difference.|Exact Logistic Regression|||Percentage of participants with a score of either 1 or 2 on the PGIC at Week 8||13.415|4.230|<0.0001
71819534|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0919|TWO_SIDED|95.0|-0.6|0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.60|0.0919
71819535|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.157||0.7554|TWO_SIDED|95.0|-0.36|0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.36|0.7554
71819536|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.166||0.015|TWO_SIDED|95.0|-0.74|-0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.74|0.0150
71819537|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.16||0.0482|TWO_SIDED|95.0|-0.64|0.0|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.64|0.0482
71819538|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.163||0.0003|TWO_SIDED|95.0|-0.93|-0.28|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.28|-0.93|0.0003
71819539|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.156||0.1182|TWO_SIDED|95.0|-0.56|0.06|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.56|0.1182
71819540|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.159||0.0008|TWO_SIDED|95.0|-0.87|-0.24|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.24|-0.87|0.0008
71819541|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.154||0.1379|TWO_SIDED|95.0|-0.54|0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.54|0.1379
71819542|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.145||0.004|TWO_SIDED|95.0|-0.71|-0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-0.71|0.0040
71819543|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.14||0.31|TWO_SIDED|95.0|-0.42|0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.42|0.3100
71679715|NCT02612610|142877126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7559|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.7559
71819544|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.148||0.0003|TWO_SIDED|95.0|-0.85|-0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.26|-0.85|0.0003
71851111|NCT03745651|143216344|SUPERIORITY||Least Squares Mean Difference|4.4|STANDARD_ERROR_OF_MEAN|1.78||0.015|TWO_SIDED|95.0|0.85|7.86|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||7.86|0.85|0.0150
71819545|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.143||0.0223|TWO_SIDED|95.0|-0.61|-0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.61|0.0223
71901544|NCT01953328|143325056|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.82|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-74.79|-62.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.86|-74.79|<0.001
71901545|NCT01953328|143325056|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.89|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.78|-55.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.99|-65.78|<0.001
71901546|NCT01953328|143325057|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.44|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-68.49|-60.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.39|-68.49|<0.001
71679716|NCT02612610|142877126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5091|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.5091
71679717|NCT02612610|142877126|SUPERIORITY_OR_OTHER_LEGACY|||||||0.279|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2790
71851112|NCT03745651|143216344|SUPERIORITY||Least Squares Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|1.77||0.0044|TWO_SIDED|95.0|1.59|8.54|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Change from Baseline in EQ VAS score at Week 8||8.54|1.59|0.0044
71901547|NCT01953328|143325057|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-63.3|-55.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.17|-63.30|<0.001
71901548|NCT01953328|143325057|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-64.87|-55.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.25|-64.87|<0.001
71901549|NCT01953328|143325057|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.39|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-67.15|-59.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.62|-67.15|<0.001
71901550|NCT01953328|143325058|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-65.56|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-70.34|-60.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-60.79|-70.34|<0.001
71901551|NCT01953328|143325058|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-57.23|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-62.05|-52.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-52.40|-62.05|<0.001
71851113|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|3.81||0.142|TWO_SIDED|95.0|-13.12|1.89|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||1.89|-13.12|0.1420
71851114|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.82||0.0375|TWO_SIDED|95.0|-15.51|-0.47|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent work time missed due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-0.47|-15.51|0.0375
71851115|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.75||0.0012|TWO_SIDED|95.0|-14.48|-3.63|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-3.63|-14.48|0.0012
71851116|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.74||0.0095|TWO_SIDED|95.0|-12.58|-1.77|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent impairment while working due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-1.77|-12.58|0.0095
71851117|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-22.69|-7.73|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.73|-22.69|<0.0001
71851118|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-12.6|STANDARD_ERROR_OF_MEAN|3.79||0.001|TWO_SIDED|95.0|-20.1|-5.18|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent overall work impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-5.18|-20.10|0.0010
71851119|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-16.18|-7.95|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-7.95|-16.18|<0.0001
71901552|NCT01953328|143325058|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.37|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-65.91|-54.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-54.83|-65.91|<0.001
71679718|NCT02612610|142877127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3887|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.3887
71851120|NCT03745651|143216345|SUPERIORITY||Least Squares Mean Difference|-10.4|STANDARD_ERROR_OF_MEAN|2.08|<|0.0001|TWO_SIDED|95.0|-14.53|-6.37|||ANCOVA|P-value was analyzed using ANCOVA model with treatment, stratification factors and Baseline score as covariates if applicable.||Percent activity impairment due to AD: Change from Baseline in WPAI-SHP v2.0 at Week 8||-6.37|-14.53|<0.0001
71851121|NCT01383616|143216349|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups||||0.85
71851122|NCT01383616|143216350|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71851123|NCT01383616|143216351|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71851124|NCT01383616|143216352|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71851125|NCT01383616|143216353|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71851126|NCT01383616|143216354|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71851127|NCT01383616|143216355|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
71851128|NCT01383616|143216356|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71851129|NCT01383616|143216357|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71901553|NCT01953328|143325058|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-56.15|STANDARD_ERROR_OF_MEAN|2.4|<|0.001|TWO_SIDED|95.0|-60.92|-51.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-51.39|-60.92|<0.001
71819546|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.166||0.0276|TWO_SIDED|95.0|-0.7|-0.04|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.04|-0.70|0.0276
71851130|NCT01383616|143216358|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||||||0.24
71851131|NCT01124916|143216366|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8728.0|STANDARD_ERROR_OF_MEAN|853.129|<|0.001|TWO_SIDED|95.0|7028.846|10427.154|||t-test, 2 sided|||The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.||10427.154|7028.846|<.001
71851132|NCT01124916|143216367|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.2|STANDARD_ERROR_OF_MEAN|7.846||0.43|TWO_SIDED|95.0|-21.769|9.369|||t-test, 2 sided|||The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.||9.369|-21.769|.43
71851133|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||TWO_SIDED|95.0|0.81|0.99|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.99|0.81|
71851134|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.02|||||TWO_SIDED|95.0|0.93|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.93|
71851135|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.14|||||TWO_SIDED|95.0|1.03|1.27|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.27|1.03|
71851136|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.88|||||TWO_SIDED|95.0|0.78|0.98|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||0.98|0.78|
71851137|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.99|||||TWO_SIDED|95.0|0.88|1.1|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.1|0.88|
71851138|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.12|||||TWO_SIDED|95.0|1.0|1.26|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.26|1.0|
71819547|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.161||0.8516|TWO_SIDED|95.0|-0.35|0.29|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.35|0.8516
71819548|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.186||0.1669|TWO_SIDED|95.0|-0.63|0.11|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.63|0.1669
71819549|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4935|TWO_SIDED|95.0|-0.48|0.23|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.48|0.4935
71819550|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.197||0.0202|TWO_SIDED|95.0|-0.86|-0.07|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.07|-0.86|0.0202
71819551|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.188||0.2683|TWO_SIDED|95.0|-0.58|0.16|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.58|0.2683
71819552|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165||0.0531|TWO_SIDED|95.0|-0.65|0.0|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.00|-0.65|0.0531
71819553|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.16||0.5609|TWO_SIDED|95.0|-0.41|0.22|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.41|0.5609
71819554|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.123||0.6779|TWO_SIDED|95.0|-0.3|0.19|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.30|0.6779
71851139|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.04||||||95.0|0.88|1.23|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.23|0.88|
71851140|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.96||||||95.0|0.81|1.13|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).||1.13|0.81|
71883032|NCT00930761|143285242|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.26||||0.03||95.0|1.01|1.57|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.||1.57|1.01|0.03
71819555|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.119||0.4559|TWO_SIDED|95.0|-0.15|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.15|0.4559
71819556|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.133||0.2254|TWO_SIDED|95.0|-0.43|0.1|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.43|0.2254
71819557|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.129||0.6437|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6437
71819558|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.133||0.6678|TWO_SIDED|95.0|-0.32|0.21|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.32|0.6678
71819559|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.129||0.9321|TWO_SIDED|95.0|-0.27|0.24|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.27|0.9321
71819560|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.157||0.9778|TWO_SIDED|95.0|-0.31|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.31|0.9778
71819561|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.152||0.9307|TWO_SIDED|95.0|-0.29|0.31|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.29|0.9307
71819562|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.172||0.6791|TWO_SIDED|95.0|-0.41|0.27|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.27|-0.41|0.6791
71851141|NCT00657709|143216374|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.92|||||TWO_SIDED|95.0|0.78|1.08|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log-transformed titers and both the limits of 95% CIs.||"The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0)."||1.08|0.78|
71851142|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval \[-10%, 10%\].||1|-1|
71851143|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
71883033|NCT00930761|143285243|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.28||||0.09||95.0|0.95|1.71|||Chi-squared|||||1.71|0.95|0.09
71883034|NCT04677959|143285282|OTHER||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0||||||||The 95% credible intervals of the odds ratio from the posterior distributions were calculated and presented.||||
71883035|NCT01970995|143285301|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|13.49|||<|0.001|TWO_SIDED|95.0|10.96|16.6||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.60|10.96|<.001
71883036|NCT01970995|143285302|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|50.67|||<|0.001|TWO_SIDED|95.0|44.88|57.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||57.20|44.88|<.001
71883037|NCT01970995|143285303|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|10.97|||<|0.001|TWO_SIDED|95.0|9.26|12.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||12.99|9.26|<.001
71883038|NCT01970995|143285304|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|44.94|||<|0.001|TWO_SIDED|95.0|42.11|47.97||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||47.97|42.11|<.001
71883039|NCT01970995|143285305|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|23.25|||<|0.001|TWO_SIDED|95.0|17.38|31.11||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||31.11|17.38|<.001
71883040|NCT04442230|143285338|SUPERIORITY|||||||0.6602|||||||Fisher Exact|||The p-values from significance tests were obtained at a one-sided significance level of 0.025.||||0.6602
71883041|NCT01604265|143285341|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.25||||0.005|TWO_SIDED|95.0|-2.11|-0.39|||ANCOVA|||The change was compared between treatment groups using a one way analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows: Change in 0-10 Numerical Rating Scale Pain Score = Baseline Pain Score + Treatment||-0.39|-2.11|0.005
71883042|NCT01604265|143285342|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.39||||0.003|TWO_SIDED|95.0|-2.27|-0.5|||ANCOVA|||"The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in 0-10 Numerical Rating Scale sleep Score = Baseline Sleep Score + Treatment"||-0.50|-2.27|0.003
71883043|NCT01604265|143285343|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.896||||0.005|TWO_SIDED|95.0|1.51|10.055|||Regression, Logistic|||"The proportion of patients who considered their condition Very Much Improved or Much Improved was compared between treatment groups using a Fisher's Exact Test. Results were presented in terms of difference in percentages, and 95% CI based on the normal approximation to the binomial, and p-value."||10.055|1.510|0.005
71883044|NCT01604265|143285344|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-6.82||||0.039|TWO_SIDED|95.0|-13.28|-0.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-0.37|-13.28|0.039
71883045|NCT01604265|143285345|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-6.95||||0.009|TWO_SIDED|95.0|-12.12|-1.77|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||-1.77|-12.12|0.009
71819563|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.167||0.7769|TWO_SIDED|95.0|-0.28|0.38|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.38|-0.28|0.7769
71819564|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.163||0.7206|TWO_SIDED|95.0|-0.38|0.26|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.38|0.7206
71819565|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.156||0.3549|TWO_SIDED|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.45|0.3549
71819566|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.164||0.0231|TWO_SIDED|95.0|-0.7|-0.05|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.05|-0.70|0.0231
71819567|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.159||0.145|TWO_SIDED|95.0|-0.55|0.08|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.55|0.1450
71901554|NCT01953328|143325059|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.54|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-49.35|-41.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.73|-49.35|<0.001
71901555|NCT01953328|143325059|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.43|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-46.78|-40.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.08|-46.78|<0.001
71901556|NCT01953328|143325059|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.98|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-44.88|-37.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.08|-44.88|<0.001
71819568|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.162||0.0855|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0855
71851144|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
71883046|NCT01604265|143285346|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.54||||0.23|TWO_SIDED|95.0|-1.64|6.71|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||6.71|-1.64|0.230
71883047|NCT01604265|143285347|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-2.53||||0.064|TWO_SIDED|95.0|-5.22|0.15|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.15|-5.22|0.064
71901557|NCT01953328|143325059|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.14|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-46.48|-39.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.80|-46.48|<0.001
71901558|NCT01953328|143325060|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-49.83|-41.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.05|-49.83|<0.001
71901559|NCT01953328|143325060|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-41.34|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-44.84|-37.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.85|-44.84|<0.001
71901560|NCT01953328|143325060|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-40.96|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-45.35|-36.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-36.57|-45.35|<0.001
71679719|NCT02612610|142877127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2333|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.2333
71679720|NCT02612610|142877127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0534|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of Extremely likely responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.0534
71679721|NCT02612610|142877128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6115|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0.6115
71679722|NCT02612610|142877128|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71819569|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.157||0.3068|TWO_SIDED|95.0|-0.47|0.15|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.47|0.3068
71883048|NCT01604265|143285348|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.44||0.905|TWO_SIDED|95.0|-4.6|5.18|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||5.18|-4.60|0.905
71883049|NCT01604265|143285349|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|2.68||||0.257|TWO_SIDED|95.0|-2.01|7.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||7.37|-2.01|0.257
71883050|NCT01604265|143285350|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.5||||0.164|TWO_SIDED|95.0|-3.64|0.63|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.63|-3.64|0.164
71883051|NCT01604265|143285352|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.09||||0.88|TWO_SIDED|95.0|-1.06|1.23|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||1.23|-1.06|0.880
71883052|NCT01604265|143285353|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.249|TWO_SIDED|95.0|-1.75|0.46|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.46|-1.75|0.249
71883053|NCT01604265|143285354|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.06||||0.535|TWO_SIDED|95.0|-0.13|0.24|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.||0.24|-0.13|0.535
71883054|NCT02599961|143285357|SUPERIORITY||LS Mean|-82.73|STANDARD_ERROR_OF_MEAN|11.363|<|0.0001|TWO_SIDED|95.0|-105.0|-60.46||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|generalized estimating equation (GEE)|||Month 0-3||-60.46|-105.00|< 0.0001
71883055|NCT02599961|143285357|SUPERIORITY||LS mean|-54.91|STANDARD_ERROR_OF_MEAN|16.097||0.0006|TWO_SIDED|95.0|-86.46|-23.36||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 4-6||-23.36|-86.46|0.0006
71883056|NCT02599961|143285357|SUPERIORITY||LS Mean|-52.53|STANDARD_ERROR_OF_MEAN|16.882||0.0019|TWO_SIDED|95.0|-85.62|-19.45||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 7-9||-19.45|-85.62|0.0019
71883057|NCT02599961|143285357|SUPERIORITY||LS Mean|-82.65|STANDARD_ERROR_OF_MEAN|15.55|<|0.0001|TWO_SIDED|95.0|-113.13|-52.17||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 10-12||-52.17|-113.13|< 0.0001
71883058|NCT00385255|143285391|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|1.06|||||TWO_SIDED|95.0|-1.36|3.56||||||Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination.||3.56|-1.36|
71819570|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.164||0.0069|TWO_SIDED|95.0|-0.77|-0.13|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.13|-0.77|0.0069
71819571|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.159||0.2174|TWO_SIDED|95.0|-0.51|0.12|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.51|0.2174
71819572|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.174||0.102|TWO_SIDED|95.0|-0.63|0.06|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.63|0.1020
71851145|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain.|Vaccines Group Differences|0.0|||||TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-1|
71851146|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
71851147|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||TWO_SIDED|95.0|0.0|2.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval \[-10%, 10%\].||2|0|
71851148|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for NZ98/254 strain.|Percentage group difference|3.0|||||TWO_SIDED|95.0|-2.0|8.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval \[-10%, 10%\].||8|-2|
71851149|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for NZ 98/254 strain.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|4.0|||Miettinen and Nurminen|The lot-to-lot difference in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval \[-10%, 10%\].||4|-6|
71851150|NCT00657709|143216376|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (-10%, 10%). If the two sided (5% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for NZ98/254 strain.|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|The lot-to-lot differences in these percentages and associated 95% CIs were computed for each pair of rMenB+OMV lots.||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval \[-10%, 10%\].||1|-9|
71901561|NCT01953328|143325060|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|1.93|<|0.001|TWO_SIDED|95.0|-42.26|-34.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.62|-42.26|<0.001
71901562|NCT01953328|143325061|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-54.77|STANDARD_ERROR_OF_MEAN|2.32|<|0.001|TWO_SIDED|95.0|-59.37|-50.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-50.17|-59.37|<0.001
71901563|NCT01953328|143325061|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.66|STANDARD_ERROR_OF_MEAN|2.17|<|0.001|TWO_SIDED|95.0|-56.95|-48.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-48.36|-56.95|<0.001
71901564|NCT01953328|143325061|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.83|STANDARD_ERROR_OF_MEAN|1.96|<|0.001|TWO_SIDED|95.0|-54.72|-46.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.93|-54.72|<0.001
71901565|NCT01953328|143325061|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.69|STANDARD_ERROR_OF_MEAN|2.04|<|0.001|TWO_SIDED|95.0|-53.74|-45.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-45.64|-53.74|<0.001
71901566|NCT01953328|143325062|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-55.45|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-60.93|-49.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-49.98|-60.93|<0.001
71901567|NCT01953328|143325062|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.95|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-55.91|-46.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.00|-55.91|<0.001
71901568|NCT01953328|143325062|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.36|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-55.93|-46.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-46.80|-55.93|<0.001
71901569|NCT01953328|143325062|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-45.44|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-50.08|-40.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-40.81|-50.08|<0.001
71901570|NCT01953328|143325063|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-66.47|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-70.58|-62.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-62.36|-70.58|<0.001
71901571|NCT01953328|143325063|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.33|STANDARD_ERROR_OF_MEAN|2.35|<|0.001|TWO_SIDED|95.0|-69.01|-59.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.66|-69.01|<0.001
71901572|NCT01953328|143325063|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-64.05|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-68.9|-59.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-59.20|-68.90|<0.001
71901573|NCT01953328|143325063|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-67.26|STANDARD_ERROR_OF_MEAN|2.07|<|0.001|TWO_SIDED|95.0|-71.36|-63.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.15|-71.36|<0.001
71901574|NCT01953328|143325064|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-68.29|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-72.75|-63.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-63.84|-72.75|<0.001
71901575|NCT01953328|143325064|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-62.53|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-68.11|-56.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-56.94|-68.11|<0.001
71901576|NCT01953328|143325064|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-63.97|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-69.44|-58.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-58.50|-69.44|<0.001
71901577|NCT01953328|143325064|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-60.62|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-65.51|-55.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-55.72|-65.51|<0.001
71901578|NCT01953328|143325065|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.8|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.8|<0.001
71901579|NCT01953328|143325065|SUPERIORITY_OR_OTHER||Treatment Difference|96.0|||<|0.001|TWO_SIDED|95.0|84.1|98.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||98.9|84.1|<0.001
71901580|NCT01953328|143325065|SUPERIORITY_OR_OTHER||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|57.1|83.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||83.4|57.1|<0.001
71901581|NCT01953328|143325065|SUPERIORITY_OR_OTHER||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|67.5|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||90.0|67.5|<0.001
71901582|NCT01953328|143325066|SUPERIORITY_OR_OTHER||Treatment Difference|98.0|||<|0.001|TWO_SIDED|95.0|86.7|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||99.6|86.7|<0.001
71819573|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.9587|TWO_SIDED|95.0|-0.33|0.35|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.33|0.9587
71901583|NCT01953328|143325066|SUPERIORITY_OR_OTHER||Treatment Difference|91.8|||<|0.001|TWO_SIDED|95.0|78.2|96.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||96.0|78.2|<0.001
71901584|NCT01953328|143325066|SUPERIORITY_OR_OTHER||Treatment Difference|75.6|||<|0.001|TWO_SIDED|95.0|59.3|85.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||85.0|59.3|<0.001
71901585|NCT01953328|143325066|SUPERIORITY_OR_OTHER||Treatment Difference|78.0|||<|0.001|TWO_SIDED|95.0|62.6|86.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).||||86.9|62.6|<0.001
71901586|NCT01953328|143325067|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-51.2|STANDARD_ERROR_OF_MEAN|6.39|<|0.001|TWO_SIDED|95.0|-63.88|-38.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-38.52|-63.88|<0.001
71901587|NCT01953328|143325067|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.08|STANDARD_ERROR_OF_MEAN|4.94|<|0.001|TWO_SIDED|95.0|-58.89|-39.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.27|-58.89|<0.001
71901588|NCT01953328|143325067|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-49.55|STANDARD_ERROR_OF_MEAN|5.14|<|0.001|TWO_SIDED|95.0|-59.74|-39.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-39.35|-59.74|<0.001
71901589|NCT01953328|143325067|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-43.93|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-53.75|-34.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.12|-53.75|<0.001
71901590|NCT01953328|143325068|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-50.07|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|95.0|-65.25|-34.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-34.90|-65.25|<0.001
71901591|NCT01953328|143325068|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-48.77|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-60.49|-37.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-37.05|-60.49|<0.001
71901592|NCT01953328|143325068|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-52.68|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-64.06|-41.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-41.30|-64.06|<0.001
71901593|NCT01953328|143325068|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-39.97|STANDARD_ERROR_OF_MEAN|5.29|<|0.001|TWO_SIDED|95.0|-50.46|-29.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-29.48|-50.46|<0.001
71901594|NCT01953328|143325069|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.93|STANDARD_ERROR_OF_MEAN|6.72|<|0.001|TWO_SIDED|95.0|-41.27|-14.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.59|-41.27|<0.001
71901595|NCT01953328|143325069|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-21.94|STANDARD_ERROR_OF_MEAN|5.34|<|0.001|TWO_SIDED|95.0|-32.54|-11.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.35|-32.54|<0.001
71901596|NCT01953328|143325069|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.01|STANDARD_ERROR_OF_MEAN|4.83|<|0.001|TWO_SIDED|95.0|-29.59|-10.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-10.43|-29.59|<0.001
71901597|NCT01953328|143325069|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.72|STANDARD_ERROR_OF_MEAN|6.78||0.01|TWO_SIDED|95.0|-34.18|-7.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-7.26|-34.18|0.010
71901598|NCT01953328|143325070|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.57|STANDARD_ERROR_OF_MEAN|9.45|<|0.001|TWO_SIDED|95.0|-46.33|-8.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.81|-46.33|<0.001
71901599|NCT01953328|143325070|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-19.97|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-31.68|-8.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.25|-31.68|<0.001
71901600|NCT01953328|143325070|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-17.17|STANDARD_ERROR_OF_MEAN|5.53|<|0.001|TWO_SIDED|95.0|-28.15|-6.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-6.19|-28.15|<0.001
71901601|NCT01953328|143325070|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-16.92|STANDARD_ERROR_OF_MEAN|7.24||0.01|TWO_SIDED|95.0|-31.29|-2.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-2.56|-31.29|0.010
71901602|NCT01953328|143325071|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|12.33|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|7.39|17.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||17.27|7.39|<0.001
71901603|NCT01953328|143325071|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|14.61|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|9.93|19.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.30|9.93|<0.001
71901604|NCT01953328|143325071|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.36|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|10.12|20.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.60|10.12|<0.001
71901605|NCT01953328|143325071|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|9.15|STANDARD_ERROR_OF_MEAN|2.26||0.001|TWO_SIDED|95.0|4.67|13.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||13.62|4.67|0.001
71901606|NCT01953328|143325072|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|13.46|STANDARD_ERROR_OF_MEAN|3.06|<|0.001|TWO_SIDED|95.0|7.4|19.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||19.53|7.40|<0.001
71901607|NCT01953328|143325072|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|15.2|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|9.87|20.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||20.52|9.87|<0.001
71901608|NCT01953328|143325072|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|16.85|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|10.74|22.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||22.95|10.74|<0.001
71901609|NCT01953328|143325072|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|10.2|STANDARD_ERROR_OF_MEAN|2.7||0.001|TWO_SIDED|95.0|4.85|15.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||15.55|4.85|0.001
71901610|NCT01953328|143325073|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.85|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-39.37|-16.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-16.34|-39.37|<0.001
71901611|NCT01953328|143325073|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.65|STANDARD_ERROR_OF_MEAN|5.17|<|0.001|TWO_SIDED|95.0|-32.91|-12.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-12.39|-32.91|<0.001
71901612|NCT01953328|143325073|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.69||0.001|TWO_SIDED|95.0|-27.4|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-8.77|-27.40|0.001
71901613|NCT01953328|143325073|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|6.12|<|0.001|TWO_SIDED|95.0|-39.31|-15.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-15.01|-39.31|<0.001
71901614|NCT01953328|143325074|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-42.48|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-14.36|-42.48|<0.001
71901615|NCT01953328|143325074|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-20.81|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.29|-9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-9.33|-32.29|<0.001
71901616|NCT01953328|143325074|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-15.05|STANDARD_ERROR_OF_MEAN|5.37||0.001|TWO_SIDED|95.0|-25.72|-4.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-4.39|-25.72|0.001
71901617|NCT01953328|143325074|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-24.35|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-36.7|-11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|||-11.99|-36.70|<0.001
71901618|NCT04710862|143325078|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
71901619|NCT04710862|143325079|SUPERIORITY||||||<|0.0005|||||||Mixed Models Analysis|||||||<0.0005
71901620|NCT04710862|143325080|SUPERIORITY|||||||0.012|||||||Mixed Models Analysis|||||||0.012
71901621|NCT04710862|143325081|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71901622|NCT04710862|143325082|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71901623|NCT04710862|143325083|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71901624|NCT04710862|143325084|SUPERIORITY|||||||0.328|||||||Mixed Models Analysis|||||||0.328
71901625|NCT02364947|143325085|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.34|STANDARD_ERROR_OF_MEAN|0.87||0.0001|TWO_SIDED|95.0|-6.05|-2.62||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.62|-6.05|0.0001
71901626|NCT02364947|143325085|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.18|STANDARD_ERROR_OF_MEAN|0.95||0.0001|TWO_SIDED|95.0|-6.05|-2.32||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis|||||-2.32|-6.05|0.0001
71901627|NCT02364947|143325086|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|0.9|<|0.0001|TWO_SIDED|95.0|-5.69|-2.16|||Mixed Models Analysis|||||-2.16|-5.69|<0.0001
71901628|NCT02364947|143325086|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.54|STANDARD_ERROR_OF_MEAN|0.98|<|0.0001|TWO_SIDED|95.0|-6.46|-2.63|||Mixed Models Analysis|||||-2.63|-6.46|<0.0001
71901629|NCT02364947|143325087|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.47|STANDARD_ERROR_OF_MEAN|2.72|<|0.0001|TWO_SIDED|95.0|-17.81|-7.13|||Mixed Models Analysis|||Change in total alcohol consumption (TAC) from baseline at Week 12||-7.13|-17.81|<0.0001
71901630|NCT02364947|143325087|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|95.0|-18.72|-7.15|||Mixed Models Analysis|||||-7.15|-18.72|<0.0001
71901631|NCT02364947|143325088|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.15|STANDARD_ERROR_OF_MEAN|2.86||0.0001|TWO_SIDED|95.0|-16.77|-5.53|||Mixed Models Analysis|||||-5.53|-16.77|0.0001
71901632|NCT02364947|143325088|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.27|STANDARD_ERROR_OF_MEAN|3.11||0.0003|TWO_SIDED|95.0|-17.37|-5.17|||Mixed Models Analysis|||||-5.17|-17.37|0.0003
71901633|NCT02364947|143325089|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|22.0|||<|0.0001|TWO_SIDED|95.0|13.6|30.4|||Cochran-Mantel-Haenszel|||||30.4|13.6|<0.0001
71901634|NCT02364947|143325089|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|15.7||||0.0007|TWO_SIDED|95.0|6.5|25.0|||Cochran-Mantel-Haenszel|||||25.0|6.5|0.0007
71901635|NCT02364947|143325090|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|18.0||||0.0002|TWO_SIDED|95.0|8.8|27.2|||Cochran-Mantel-Haenszel|||||27.2|8.8|0.0002
71901636|NCT02364947|143325090|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|20.6||||0.0001|TWO_SIDED|95.0|10.4|30.8|||Cochran-Mantel-Haenszel|||||30.8|10.4|0.0001
71901637|NCT02364947|143325091|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|17.8|||<|0.0001|TWO_SIDED|95.0|10.5|25.1|||Cochran-Mantel-Haenszel|||||25.1|10.5|<0.0001
71901638|NCT02364947|143325091|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.3||||0.0002|TWO_SIDED|95.0|6.4|22.2|||Cochran-Mantel-Haenszel|||||22.2|6.4|0.0002
71901639|NCT02364947|143325092|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|11.0||||0.0079|TWO_SIDED|95.0|2.9|19.1|||Cochran-Mantel-Haenszel|||||19.1|2.9|0.0079
71901640|NCT02364947|143325092|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.8||||0.001|TWO_SIDED|95.0|5.8|23.9|||Cochran-Mantel-Haenszel|||||23.9|5.8|0.0010
71901641|NCT02364947|143325093|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|9.9||||0.0022|TWO_SIDED|95.0|3.5|16.3|||Cochran-Mantel-Haenszel|||||16.3|3.5|0.0022
71901642|NCT02364947|143325093|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|11.1||||0.0016|TWO_SIDED|95.0|3.8|18.3|||Cochran-Mantel-Haenszel|||||18.3|3.8|0.0016
71901643|NCT02364947|143325094|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|13.6||||0.0003|TWO_SIDED|95.0|6.2|20.9|||Cochran-Mantel-Haenszel|||||20.9|6.2|0.0003
71901644|NCT02364947|143325094|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|12.8||||0.0013|TWO_SIDED|95.0|4.6|21.0|||Cochran-Mantel-Haenszel|||||21.0|4.6|0.0013
71901645|NCT02364947|143325095|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|15.2||||0.0002|TWO_SIDED|95.0|7.1|23.3|||Cochran-Mantel-Haenszel|||||23.3|7.1|0.0002
71901646|NCT02364947|143325095|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|17.9||||0.0001|TWO_SIDED|95.0|8.9|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.9|0.0001
71901647|NCT02364947|143325096|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|8.0||||0.0724|TWO_SIDED|95.0|-0.7|16.7|||Cochran-Mantel-Haenszel|||||16.7|-0.7|0.0724
71901648|NCT02364947|143325096|SUPERIORITY_OR_OTHER_LEGACY|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|19.6||||0.0001|TWO_SIDED|95.0|9.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|9.9|0.0001
71901649|NCT02364947|143325097|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07||0.0002|TWO_SIDED|95.0|-0.4|-0.13|||Mixed Models Analysis|||||-0.13|-0.40|0.0002
71901650|NCT02364947|143325097|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0001|TWO_SIDED|95.0|-0.45|-0.15|||Mixed Models Analysis|||||-0.15|-0.45|0.0001
71901651|NCT02364947|143325098|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.48|-0.18|||Mixed Models Analysis|||||-0.18|-0.48|<0.0001
71901652|NCT02364947|143325098|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.51|-0.19|||Mixed Models Analysis|||||-0.19|-0.51|<0.0001
71901653|NCT02364947|143325099|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.69|-0.33|||Mixed Models Analysis|||||-0.33|-0.69|<0.0001
71901654|NCT02364947|143325099|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.67|-0.27|||Mixed Models Analysis|||||-0.27|-0.67|<0.0001
71901655|NCT02364947|143325100|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.7|-0.31|||Mixed Models Analysis|||||-0.31|-0.70|<0.0001
71901656|NCT02364947|143325100|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.77|-0.33|||Mixed Models Analysis|||||-0.33|-0.77|<0.0001
71901657|NCT02364947|143325101|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.192|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|-0.262|-0.121|||Mixed Models Analysis|||||-0.121|-0.262|<0.0001
71819574|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.203||0.169|TWO_SIDED|95.0|-0.69|0.12|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.69|0.1690
71819575|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.197||0.7919|TWO_SIDED|95.0|-0.34|0.44|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.44|-0.34|0.7919
71901658|NCT02364947|143325101|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.156|STANDARD_ERROR_OF_MEAN|0.039||0.0001|TWO_SIDED|95.0|-0.232|-0.08|||Mixed Models Analysis|||||-0.080|-0.232|0.0001
71901659|NCT02364947|143325102|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.168|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|-0.248|-0.088|||Mixed Models Analysis|||||-0.088|-0.248|<0.0001
71901660|NCT02364947|143325102|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.139|STANDARD_ERROR_OF_MEAN|0.044||0.0017|TWO_SIDED|95.0|-0.226|-0.052|||Mixed Models Analysis|||||-0.052|-0.226|0.0017
71901661|NCT02364947|143325103|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.031||0.0234|TWO_SIDED|95.0|-0.13|-0.009|||Mixed Models Analysis|||||-0.009|-0.130|0.0234
71901662|NCT02364947|143325103|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1374|TWO_SIDED|95.0|-0.115|0.016|||Mixed Models Analysis|||Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.||0.016|-0.115|0.1374
71901663|NCT02364947|143325104|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.066|STANDARD_ERROR_OF_MEAN|0.031||0.0348|TWO_SIDED|95.0|-0.127|-0.005|||Mixed Models Analysis|||||-0.005|-0.127|0.0348
71901664|NCT02364947|143325104|SUPERIORITY_OR_OTHER_LEGACY|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.034||0.1444|TWO_SIDED|95.0|-0.116|0.017|||Mixed Models Analysis|||||0.017|-0.116|0.1444
71901665|NCT00262080|143325107|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037||95.0||||no adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|non-parametric Wilcoxon Rank Sum test|||The primary efficacy analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.037
71901666|NCT00262080|143325108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Wilcoxon Rank Sum Test.|||The analysis compared the change from baseline in MSCS score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.044
71901667|NCT00262080|143325112|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||The Log-Rank test was used to compare the time distribution between the two treatment groups.||||0.055
71901668|NCT02808312|143325122|OTHER|Two-sided 90% Confidence Intervals (CIs) were calculated for the ratios of geometric least-squares means (GLSMs) of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7869|||||TWO_SIDED|90.0|1.2885|2.4781||||||An analysis of variance (ANOVA) model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||2.4781|1.2885|
71901669|NCT02808312|143325122|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4868|||||TWO_SIDED|90.0|1.6735|3.6954||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||3.6954|1.6735|
71679723|NCT02612610|142877128|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Never responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71901670|NCT02808312|143325122|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.324|||||TWO_SIDED|90.0|4.3675|9.1569||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUClast) for each cohort.||9.1569|4.3675|
71901671|NCT02808312|143325123|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7628|||||TWO_SIDED|90.0|1.275|2.4374||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||2.4374|1.2750|
71901672|NCT02808312|143325123|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.4559|||||TWO_SIDED|90.0|1.6531|3.6486||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||3.6486|1.6531|
71819576|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.205||0.0192|TWO_SIDED|95.0|-0.89|-0.08|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.08|-0.89|0.0192
71819577|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.196||0.3887|TWO_SIDED|95.0|-0.56|0.22|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.56|0.3887
71819578|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0719|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0719
71819579|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.185||0.1195|TWO_SIDED|95.0|-0.66|0.08|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.66|0.1195
71819580|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.079||0.9552|TWO_SIDED|95.0|-0.16|0.15|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.16|0.9552
71819581|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.076||0.0384|TWO_SIDED|95.0|-0.31|-0.01|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.01|-0.31|0.0384
71901673|NCT02808312|143325123|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|6.2497|||||TWO_SIDED|90.0|4.2965|9.091||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (AUCinf) for each cohort.||9.0910|4.2965|
71901674|NCT02808312|143325124|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.5703|||||TWO_SIDED|90.0|1.0723|2.2995||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.2995|1.0723|
71901675|NCT02808312|143325124|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.7343|||||TWO_SIDED|90.0|1.2193|2.4667||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||2.4667|1.2193|
71901676|NCT02808312|143325124|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PK parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|2.5369|||||TWO_SIDED|90.0|1.7562|3.6648||||||An ANOVA model with hepatic function group as a fixed effect was fitted to the natural logarithmic transformation of PK parameters (Cmax) for each cohort.||3.6648|1.7562|
71679724|NCT02612610|142877129|SUPERIORITY_OR_OTHER_LEGACY|||||||0||||||"A p-value of zero was calculated if all participants (100%) had No Taste Effect Noted or Not at All responses in both comparison groups."|Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||0
71679725|NCT02612610|142877129|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71679726|NCT02612610|142877129|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of No Taste Effect Noted or Not at All responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."||||<0.0001
71679727|NCT02783729|142877136|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.773|||=|0.0003|TWO_SIDED|95.0|0.672|0.889||Based on mixed effect model repeated measurement (MMRM) model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.889|0.672|= 0.0003
71679728|NCT02783729|142877136|SUPERIORITY||LSGM Ratio|0.723|||<|0.0001|TWO_SIDED|95.0|0.628|0.832||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||||0.832|0.628|< 0.0001
71679729|NCT02783729|142877137|SUPERIORITY||Least Squares Mean (LSM) Difference|7.07|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|5.61|8.54||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||8.54|5.61|< 0.0001
71679730|NCT02783729|142877137|SUPERIORITY||LSM Difference|8.03|STANDARD_ERROR_OF_MEAN|0.746|<|0.0001|TWO_SIDED|95.0|6.57|9.49||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||||9.49|6.57|< 0.0001
71679731|NCT02783729|142877138|SUPERIORITY||LSM Difference|-23.96|STANDARD_ERROR_OF_MEAN|3.068|<|0.0001|TWO_SIDED|95.0|-29.98|-17.95||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||||-17.95|-29.98|< 0.0001
71679732|NCT02783729|142877138|SUPERIORITY||LSM Difference|-25.35|STANDARD_ERROR_OF_MEAN|3.067|<|0.0001|TWO_SIDED|95.0|-31.36|-19.34|||MMRM|||||-19.34|-31.36|< 0.0001
71679733|NCT02783729|142877139|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-6.65|STANDARD_ERROR_OF_MEAN|2.298|=|0.0038|TWO_SIDED|95.0|-11.15|-2.15|||MMRM|||||-2.15|-11.15|= 0.0038
71679734|NCT02783729|142877139|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.309|=|0.0005|TWO_SIDED|95.0|-12.53|-3.47|||MMRM|||||-3.47|-12.53|= 0.0005
71679735|NCT02783729|142877140|SUPERIORITY||LSM Difference|-9.63|STANDARD_ERROR_OF_MEAN|4.029|=|0.0171|TWO_SIDED|95.0|-17.53|-1.72||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 5 mg||-1.72|-17.53|= 0.0171
71679736|NCT02783729|142877140|SUPERIORITY||LSM Difference|-10.74|STANDARD_ERROR_OF_MEAN|4.04|=|0.008|TWO_SIDED|95.0|-18.67|-2.81||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 10 mg||-2.81|-18.67|= 0.008
71679737|NCT02783729|142877141|SUPERIORITY||LSGM Ratio|0.874|||=|0.0218|TWO_SIDED|95.0|0.78|0.981||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||0.981|0.78|= 0.0218
71679738|NCT02783729|142877141|OTHER||LSGM Ratio|0.818|||=|0.0006|TWO_SIDED|95.0|0.729|0.917||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||0.917|0.729|= 0.0006
71679739|NCT02783729|142877141|SUPERIORITY||LSGM Ratio|0.634|||<|0.0001|TWO_SIDED|95.0|0.556|0.724||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||0.724|0.556|< 0.0001
71679740|NCT02783729|142877141|SUPERIORITY||LSGM Ratio|0.594|||<|0.0001|TWO_SIDED|95.0|0.521|0.677||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||0.677|0.521|< 0.0001
71679741|NCT02783729|142877141|SUPERIORITY||LSM Difference|-6.16|STANDARD_ERROR_OF_MEAN|2.544|=|0.0154|TWO_SIDED|95.0|-11.15|-1.17||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||-1.17|-11.15|= 0.0154
71679742|NCT02783729|142877141|SUPERIORITY||LSM Difference|-15.03|STANDARD_ERROR_OF_MEAN|2.542|<|0.0001|TWO_SIDED|95.0|-20.01|-10.05||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 10 mg||-10.05|-20.01|< 0.0001
71901677|NCT02808312|143325135|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8722|||||TWO_SIDED|90.0|0.6827|1.1144||||||||1.1144|0.6827|
71851151|NCT00657709|143216379|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.84|||||TWO_SIDED|95.0|0.76|0.94|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.94|0.76|
71851152|NCT00657709|143216379|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.77|||||TWO_SIDED|95.0|0.67|0.89|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least square means of the log10-transformed titers and their associated 95% CIs.||Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.89|0.67|
71851153|NCT00657709|143216379|NON_INFERIORITY_OR_EQUIVALENCE|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.8|||||TWO_SIDED|95.0|0.71|0.91|||ANOVA|GMCs and 95% CIs were constructed by exponentiating (base 10) the least squares means of the log10-transformed titers and their associated 95% CIS.||Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.||0.91|0.71|
71851154|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-1.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-1|
71851155|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-5.0|||||TWO_SIDED|95.0|-12.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-12|
71851156|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.||2|-2|
71851157|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-4.0|||||TWO_SIDED|95.0|-9.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.||1|-9|
71851158|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-5|
71851159|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|-5.0|||||TWO_SIDED|95.0|-11.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||-1|-11|
71901678|NCT02808312|143325135|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0731|||||TWO_SIDED|90.0|0.8295|1.3883||||||||1.3883|0.8295|
71901679|NCT02808312|143325135|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1475|||||TWO_SIDED|90.0|0.8783|1.4992||||||||1.4992|0.8783|
71901680|NCT02808312|143325136|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8188|||||TWO_SIDED|90.0|0.5837|1.1486||||||||1.1486|0.5837|
71901681|NCT02808312|143325136|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.1323|||||TWO_SIDED|90.0|0.8772|1.4615||||||||1.4615|0.8772|
71901682|NCT02808312|143325136|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3563|||||TWO_SIDED|90.0|1.0468|1.7574||||||||1.7574|1.0468|
71901683|NCT02808312|143325137|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0658|||||TWO_SIDED|90.0|0.8275|1.3726||||||||1.3726|0.8275|
71901684|NCT02808312|143325137|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.2942|||||TWO_SIDED|90.0|0.9663|1.7334||||||||1.7334|0.9663|
71901685|NCT02808312|143325137|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.8225|||||TWO_SIDED|90.0|0.5479|1.2347||||||||1.2347|0.5479|
71901686|NCT02808312|143325138|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between mild hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.0806|||||TWO_SIDED|90.0|0.791|1.4762||||||||1.4762|0.7910|
71901687|NCT02808312|143325138|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between moderate hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|1.3729|||||TWO_SIDED|90.0|0.9663|1.9506||||||||1.9506|0.9663|
71901688|NCT02808312|143325138|OTHER|Two-sided 90% CIs were calculated for the ratios of GLSMs of PD parameters between severe hepatic impairment group and the control (normal hepatic function) group.|GLSM ratio|0.903|||||TWO_SIDED|90.0|0.6142|1.3275||||||||1.3275|0.6142|
71901689|NCT02713230|143325139|SUPERIORITY||LSMD|-117.688|||<|0.0001|TWO_SIDED|95.0|-150.896|-84.48|||ANOVA|||||-84.480|-150.896|<0.0001
71901690|NCT02713230|143325140|SUPERIORITY||LSM treatment ratio|0.22|||<|0.0001|TWO_SIDED|95.0|0.131|0.371|||ANOVA|||||0.371|0.131|<0.0001
71901691|NCT02713230|143325141|SUPERIORITY||Treatment difference|0.116||||0.008|TWO_SIDED|95.0|0.032|0.2|||Cochran-Mantel-Haenszel|||||0.200|0.032|0.008
71901692|NCT02713230|143325142|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71901693|NCT03100942|143325143|SUPERIORITY||Difference in Response Rates|15.6||||0.1597|TWO_SIDED|95.0|-6.3|37.6||P-values were obtained from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||37.6|-6.3|0.1597
71901694|NCT03100942|143325143|SUPERIORITY||Difference in Response Rates|16.6||||0.1694|TWO_SIDED|95.0|-5.1|38.3||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||38.3|-5.1|0.1694
71901695|NCT03100942|143325143|SUPERIORITY||Difference in Response Rates|8.1||||0.3309|TWO_SIDED|95.0|-13.2|29.4||P-values were obtained from CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.|||29.4|-13.2|0.3309
71901696|NCT03100942|143325144|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|1.05||0.2066|TWO_SIDED|95.0|-0.7|3.4|||MMRM|||Least Squares (LS) Means, 95% confidence interval (CI), and P-values were obtained from Mixed Effects Model for Repeated Measures (MMRM) with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||3.4|-0.7|0.2066
71851160|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.||2|-4|
71851161|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-5.0|-1.0|||Miettinen and Nurminen|||Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%||-1|-5|
71851162|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.||1|-3|
71851163|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||Miettinen and Nurminen|||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.||7|-7|
71851164|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||TWO_SIDED|95.0|-4.0|0.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.||0|-4|
71851165|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|2.0|||||TWO_SIDED|95.0|-4.0|8.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.||8|-4|
71851166|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-2.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa\_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.||1|-2|
71851167|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-4.0|3.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.||3|-4|
71901697|NCT03100942|143325144|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.04||0.3998|TWO_SIDED|95.0|-2.9|1.2|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.2|-2.9|0.3998
71901698|NCT03100942|143325144|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.04||0.5113|TWO_SIDED|95.0|-1.4|2.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.7|-1.4|0.5113
71901699|NCT03100942|143325145|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.47||0.9446|TWO_SIDED|95.0|-0.9|1.0|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||1.0|-0.9|0.9446
71901700|NCT03100942|143325145|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.47||0.3977|TWO_SIDED|95.0|-1.3|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.3|0.3977
71901701|NCT03100942|143325145|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.47||0.4966|TWO_SIDED|95.0|-1.2|0.6|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.6|-1.2|0.4966
71901702|NCT03100942|143325146|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.1||0.9564|TWO_SIDED|95.0|-2.2|2.1|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.1|-2.2|0.9564
71901703|NCT03100942|143325146|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.07||0.2788|TWO_SIDED|95.0|-3.3|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-3.3|0.2788
71819582|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.2582|TWO_SIDED|95.0|-0.3|0.08|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.30|0.2582
71819583|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.094||0.1511|TWO_SIDED|95.0|-0.32|0.05|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.32|0.1511
71819584|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.126||0.4631|TWO_SIDED|95.0|-0.34|0.16|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.34|0.4631
71851168|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.||1|-3|
71851169|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||TWO_SIDED|95.0|-3.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.||4|-3|
71819585|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.123||0.4628|TWO_SIDED|95.0|-0.33|0.15|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.33|0.4628
71851170|NCT00657709|143216380|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-8.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.||2|-8|
71851171|NCT00657709|143216381|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||TWO_SIDED|95.0|-9.0|4.0|||Miettinen and Nurminen|||Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||4|-9|
71851172|NCT00657709|143216381|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-9.0|||||TWO_SIDED|95.0|-16.0|-3.0|||Miettinen and Nurminen|||Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||-3|-16|
71851173|NCT00657709|143216381|NON_INFERIORITY_OR_EQUIVALENCE|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-7.0|2.0|||Miettinen and Nurminen|||Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.||2|-7|
71851174|NCT05265247|143216385|EQUIVALENCE|The two formulations were considered to be bioequivalent if the point estimate for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9531|||||TWO_SIDED|90.0|0.851|1.0673||||||||1.0673|0.8510|
71679743|NCT02783729|142877141|SUPERIORITY||LSM Difference|-7.72|STANDARD_ERROR_OF_MEAN|2.876|=|0.0073|TWO_SIDED|95.0|-13.36|-2.08||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||-2.08|-13.36|= 0.0073
71679744|NCT02783729|142877141|SUPERIORITY||LSM Difference|-9.1|STANDARD_ERROR_OF_MEAN|2.883|=|0.0016|TWO_SIDED|95.0|-14.75|-3.45|||MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||-3.45|-14.75|= 0.0016
71679745|NCT02783729|142877141|SUPERIORITY||LSM Difference|10.25|STANDARD_ERROR_OF_MEAN|3.094|=|0.001|TWO_SIDED|95.0|4.18|16.32||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 5 mg||16.32|4.18|= 0.001
71679746|NCT02783729|142877141|SUPERIORITY||LSM Difference|23.1|STANDARD_ERROR_OF_MEAN|3.085|<|0.0001|TWO_SIDED|95.0|17.04|29.15||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 10 mg||29.15|17.04|< 0.0001
71851175|NCT05265247|143216386|EQUIVALENCE|The two formulations were considered to be bioequivalent if the 90% 2-sided confidence interval (CI) for the ratio lies completely within the range of 0.8-1.25.|Ratio of Geometric least squares mean|0.9538|||||TWO_SIDED|90.0|0.898|1.0132||||||||1.0132|0.8980|
71851176|NCT00134056|143216393|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.64|TWO_SIDED|95.0|0.9|1.19|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.19|0.90|0.64
71851177|NCT00134056|143216394|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.81|TWO_SIDED|95.0|0.89|1.16|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.||1.16|0.89|0.81
71851178|NCT00872339|143216412|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
71851179|NCT00872339|143216414|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<.001
71851180|NCT02312258|143216425|SUPERIORITY||Hazard Ratio (HR)|1.09|||=|0.473|TWO_SIDED|95.0|0.861|1.381|||Log Rank||||"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), International Staging System (ISS) stage before initial therapy (stage I or II vs stage III), age (\<75 versus \[vs\] \>=75 years) at randomization, and best response to initial therapy (complete response (CR) or very good partial response (VGPR) vs partial response (PR)).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 versus\[vs\] \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.381|0.861|=0.473
71851181|NCT02312258|143216427|SUPERIORITY||Hazard Ratio (HR)|0.655|||<|0.001|TWO_SIDED|95.0|0.537|0.799|||Log Rank||||"P-value comparing TTP between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.799|0.537|<0.001
71851182|NCT02312258|143216428|SUPERIORITY||Hazard Ratio (HR)|0.984|||=|0.893|TWO_SIDED|95.0|0.777|1.246|||Log Rank||||"P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.246|0.777|=0.893
71679747|NCT02783729|142877141|SUPERIORITY||LSM Difference|19.41|STANDARD_ERROR_OF_MEAN|3.457|<|0.0001|TWO_SIDED|95.0|12.63|26.2||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 5 mg||26.2|12.63|< 0.0001
71679748|NCT02783729|142877141|SUPERIORITY||LSM Difference|24.1|STANDARD_ERROR_OF_MEAN|3.456|<|0.0001|TWO_SIDED|95.0|17.32|30.88||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 10 mg||30.88|17.32|< 0.0001
71679749|NCT02783729|142877142|SUPERIORITY||LSGM Ratio|0.898|||=|0.0122|TWO_SIDED|95.0|0.825|0.977||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.977|0.825|= 0.0122
71901704|NCT03100942|143325146|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.06||0.8047|TWO_SIDED|95.0|-1.8|2.3|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||2.3|-1.8|0.8047
71901705|NCT03100942|143325147|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.46||0.6782|TWO_SIDED|95.0|-1.1|0.7|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.7|-1.1|0.6782
71901706|NCT03100942|143325147|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.45||0.9171|TWO_SIDED|95.0|-0.8|0.9|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.9|-0.8|0.9171
71901707|NCT03100942|143325147|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45||0.4641|TWO_SIDED|95.0|-1.2|0.5|||MMRM|||LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.||0.5|-1.2|0.4641
71901708|NCT04009096|143325148|OTHER|||||||0.14||||||Two tailed p value reported for Mann-Whitney test comparing controls with each vaccinees|Wilcoxon (Mann-Whitney)|||Comparison of pooled data from Groups 1, 2 and 3 volunteers who completed CHMI with pooled data of infectivity controls (unvaccinated) from CHMI study running in parallel (VAC069 study)||||0.14
71901709|NCT05151471|143325153|SUPERIORITY|||||||0.78|||||||Log Rank|||||||0.78
71901710|NCT05151471|143325154|SUPERIORITY|||||||0.704|||||||ANCOVA|||Week 72||||0.704
71901711|NCT05151471|143325154|SUPERIORITY|||||||0.131|||||||ANCOVA|||Week 96||||0.131
71901712|NCT05151471|143325155|SUPERIORITY|||||||0.954|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.954
71901713|NCT05151471|143325155|SUPERIORITY|||||||0.591|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.591
71901714|NCT05151471|143325156|SUPERIORITY|||||||0.513|||||||Mixed Model for Repeated Measures (MMRM)|||Week 72||||0.513
71901715|NCT05151471|143325156|SUPERIORITY|||||||0.344|||||||Mixed Model for Repeated Measures (MMRM)|||Week 84||||0.344
71901716|NCT05151471|143325156|SUPERIORITY|||||||0.142|||||||Mixed Model for Repeated Measures (MMRM)|||Week 96||||0.142
71901717|NCT04263142|143325160|OTHER||Ratio|0.998|||||TWO_SIDED|90.0|0.9263|1.0757|||||Analysis was performed using analysis of variance (ANOVA) with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0757|0.9263|
71901718|NCT04263142|143325161|OTHER||Ratio|1.002|||||TWO_SIDED|90.0|0.9321|1.0781|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablets/capsules.|||1.0781|0.9321|
71901719|NCT04263142|143325162|OTHER||Ratio|1.093|||||TWO_SIDED|90.0|0.9885|1.208|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablets/capsules.|||1.2080|0.9885|
71901720|NCT04263142|143325164|OTHER||Ratio|2.926|||||TWO_SIDED|90.0|2.3703|3.6107|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.6107|2.3703|
71901721|NCT04263142|143325164|OTHER||Ratio|2.594|||||TWO_SIDED|90.0|2.1003|3.2038|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-inf). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.2038|2.1003|
71901722|NCT04263142|143325165|OTHER||Ratio|3.146|||||TWO_SIDED|90.0|2.5925|3.8178|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||3.8178|2.5925|
71901723|NCT04263142|143325165|OTHER||Ratio|2.785|||||TWO_SIDED|90.0|2.2943|3.3807|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter AUC(0-t). Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.3807|2.2943|
71901724|NCT04263142|143325166|OTHER||Ratio|4.101|||||TWO_SIDED|90.0|3.2442|5.183|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (moderate fat)/(fasted)|||5.1830|3.2442|
71901725|NCT04263142|143325166|OTHER||Ratio|3.08|||||TWO_SIDED|90.0|2.4359|3.8935|||||Analysis was performed using ANOVA with treatment, period, and sequence as fixed effects and participant as a random effect on the natural log-transformed parameter Cmax. Ratio of GSK3640254 200 mg tablet (high fat)/(fasted)|||3.8935|2.4359|
71901726|NCT01623531|143325258|SUPERIORITY||Mann-Whitney U test|386.0|STANDARD_ERROR_OF_MEAN|47.5||0.908|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distributions of cumulative transfusion units did not differ significantly between patients receiving either RiaSTAP (median = 0, IQR = 0-1) or Placebo (median = 0, IQR = 0.1), U = 386, SE = 47.60, p = .908.|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the data were not normally distributed, and primary outcomes were zero inflated. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug.||||.908
71901727|NCT01623531|143325259|SUPERIORITY||Mean Difference (Net)|-0.498|STANDARD_ERROR_OF_MEAN|0.239||0.047|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.047
71901728|NCT01623531|143325260|SUPERIORITY||Mean Difference (Net)|-0.004|STANDARD_ERROR_OF_MEAN|0.0116||0.729|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.729
71819586|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9005|TWO_SIDED|95.0|-0.23|0.2|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.23|0.9005
71819587|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.107||0.1121|TWO_SIDED|95.0|-0.38|0.04|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.38|0.1121
71819588|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.4167|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4167
71819589|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.141||0.4071|TWO_SIDED|95.0|-0.4|0.16|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.40|0.4071
71819590|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1278|TWO_SIDED|95.0|-0.53|0.07|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.53|0.1278
71819591|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.145||0.0573|TWO_SIDED|95.0|-0.57|0.01|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.57|0.0573
71819592|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.156||0.4842|TWO_SIDED|95.0|-0.42|0.2|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.42|0.4842
71819593|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.152||0.0692|TWO_SIDED|95.0|-0.58|0.02|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.58|0.0692
71819594|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.157||0.4028|TWO_SIDED|95.0|-0.44|0.18|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.44|0.4028
71851183|NCT02312258|143216429|SUPERIORITY||Hazard Ratio (HR)|0.777|||=|0.018|TWO_SIDED|95.0|0.631|0.957|||Log Rank||||"P-value comparing TTNT between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.957|0.631|=0.018
71819595|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.154||0.0354|TWO_SIDED|95.0|-0.63|-0.02|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.02|-0.63|0.0354
71851184|NCT02312258|143216430|SUPERIORITY||Hazard Ratio (HR)|1.111|||=|0.462|TWO_SIDED|95.0|0.839|1.47|||Log Rank||||"P-value comparing Time to End of Next Line Therapy between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.470|0.839|=0.462
71851185|NCT02312258|143216431|SUPERIORITY||Hazard Ratio (HR)|1.293|||||TWO_SIDED|95.0|0.968|1.727|||||||Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.|1.727|0.968|
71851186|NCT02312258|143216434|SUPERIORITY||Hazard Ratio (HR)|0.582|||=|0.001|TWO_SIDED|95.0|0.425|0.796|||Log Rank|||PFS for Participants with Known MRD+ at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.796|0.425|=0.001
71901729|NCT01623531|143325261|SUPERIORITY||Mean Difference (Net)|-0.321|STANDARD_ERROR_OF_MEAN|3.699||0.93|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.||||.93
71901730|NCT01623531|143325262|SUPERIORITY||Mean Difference (Net)|-11.821|STANDARD_ERROR_OF_MEAN|8.471||0.169|TWO_SIDED||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|||||.169
71901731|NCT01623531|143325263|SUPERIORITY||Mann-Whitney U test|450.5|STANDARD_ERROR_OF_MEAN|54.163||0.035|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.035
71901732|NCT01623531|143325264|SUPERIORITY||Mann-Whitney U test|337.5|STANDARD_ERROR_OF_MEAN|51.591||0.794|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.794
71901733|NCT01623531|143325265|SUPERIORITY||Mann-Whitney U test|335.5|STANDARD_ERROR_OF_MEAN|52.957||0.828|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.828
71901734|NCT01623531|143325266|SUPERIORITY||Mann-Whitney U test|396.0|STANDARD_ERROR_OF_MEAN|60.944||0.941|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.941
71901735|NCT01623531|143325267|SUPERIORITY||Mann-Whitney U test|494.5|STANDARD_ERROR_OF_MEAN|60.783||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.09
71901736|NCT01623531|143325268|SUPERIORITY||Mann-Whitney U test|418.5|STANDARD_ERROR_OF_MEAN|60.93||0.658|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.658
71901737|NCT01623531|143325269|SUPERIORITY||Mann-Whitney U test|472.5|STANDARD_ERROR_OF_MEAN|60.727||0.182|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.182
71901738|NCT01623531|143325270|SUPERIORITY||Mann-Whitney U test|428.0|STANDARD_ERROR_OF_MEAN|60.919||0.549|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.549
71901739|NCT01623531|143325271|SUPERIORITY||Mann-Whitney U test|530.5|STANDARD_ERROR_OF_MEAN|60.816||0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The distribution of FIBTEM MCF (maximum clot firmness) was significantly different between RiaSTAP (median = 27 mm, IQR = 24, 30), and placebo (median = 23 mm, IQR = 22, 27) groups, U-test = 530.5, SE = 60.816, p = .022).|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the FIBTEM MCF data was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.022
71901740|NCT01623531|143325272|SUPERIORITY||Mann-Whitney U test|437.0|STANDARD_ERROR_OF_MEAN|60.93||0.455|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.455
71901741|NCT01623531|143325273|SUPERIORITY||Mann-Whitney U test|432.5|STANDARD_ERROR_OF_MEAN|60.819||0.5|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.||||.5
71901742|NCT01623531|143325274|SUPERIORITY|||||||1|||||||Fisher Exact|Significance (2-sided) using Fisher's Exact Test.||||||1.0
71901743|NCT04184622|143325289|SUPERIORITY||Least Square (LS) Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.6|-12.5|||Mixed Models Analysis|||||-12.5|-14.6|<0.001
71901744|NCT04184622|143325289|SUPERIORITY||LS Mean Difference (Net)|-18.9|||<|0.001|TWO_SIDED|95.0|-20.0|-17.8|||Mixed Models Analysis|||||-17.8|-20.0|<0.001
71901745|NCT04184622|143325289|SUPERIORITY||LS Mean Difference (Net)|-20.1|||<|0.001|TWO_SIDED|95.0|-21.2|-19.0|||Mixed Models Analysis|||||-19.0|-21.2|<0.001
71901746|NCT04184622|143325290|SUPERIORITY||Odds Ratio (OR)|23.99|||<|0.001|TWO_SIDED|95.0|17.43|33.02|||Regression, Logistic|||||33.02|17.43|<0.001
71901747|NCT04184622|143325290|SUPERIORITY||Odds Ratio (OR)|73.63|||<|0.001|TWO_SIDED|95.0|46.98|115.39|||Regression, Logistic|||||115.39|46.98|<0.001
71901748|NCT04184622|143325290|SUPERIORITY||Odds Ratio (OR)|75.48|||<|0.001|TWO_SIDED|95.0|47.86|119.03|||Regression, Logistic|||||119.03|47.86|<0.001
71901749|NCT04184622|143325291|SUPERIORITY||LS Mean Difference (Net)|-10.7|||<|0.001|TWO_SIDED|95.0|-11.2|-10.1|||Mixed Models Analysis|||||-10.1|-11.2|<0.001
71901750|NCT04184622|143325292|SUPERIORITY||Odds Ratio (OR)|19.03|||<|0.001|TWO_SIDED|95.0|14.15|25.6|||Regression, Logistic|||||25.60|14.15|<0.001
71901751|NCT04184622|143325292|SUPERIORITY||Odds Ratio (OR)|44.17|||<|0.001|TWO_SIDED|95.0|31.75|61.45|||Regression, Logistic|||||61.45|31.75|<.001
71901752|NCT04184622|143325292|SUPERIORITY||Odds Ratio (OR)|65.64|||<|0.001|TWO_SIDED|95.0|45.94|93.77|||Regression, Logistic|||||93.77|45.94|<.001
71901753|NCT04184622|143325293|SUPERIORITY||Odds Ratio (OR)|17.08|||<|0.001|TWO_SIDED|95.0|11.83|24.66|||Regression, Logistic|||||24.66|11.83|<0.001
71901754|NCT04184622|143325293|SUPERIORITY||Odds Ratio (OR)|51.84|||<|0.001|TWO_SIDED|95.0|35.42|75.88|||Regression, Logistic|||||75.88|35.42|<0.001
71901755|NCT04184622|143325293|SUPERIORITY||Odds Ratio (OR)|66.63|||<|0.001|TWO_SIDED|95.0|45.23|98.16|||Regression, Logistic|||||98.16|45.23|<0.001
71901756|NCT04184622|143325294|SUPERIORITY||Odds Ratio (OR)|36.93|||<|0.001|TWO_SIDED|95.0|18.37|74.22|||Regression, Logistic|||||74.22|18.37|<0.001
71901757|NCT04184622|143325294|SUPERIORITY||Odds Ratio (OR)|109.45|||<|0.001|TWO_SIDED|95.0|54.5|219.81|||Regression, Logistic|||||219.81|54.50|<0.001
71901758|NCT04184622|143325294|SUPERIORITY||Odds Ratio (OR)|150.59|||<|0.001|TWO_SIDED|95.0|74.85|302.97|||Regression, Logistic|||||302.97|74.85|<0.001
71901759|NCT04184622|143325295|SUPERIORITY||LS Mean Difference (Net)|-11.2|||<|0.001|TWO_SIDED|95.0|-12.3|-10.0|||Mixed Models Analysis|||||-10.0|-12.3|<0.001
71901760|NCT04184622|143325295|SUPERIORITY||LS Mean Difference (Net)|-16.0|||<|0.001|TWO_SIDED|95.0|-17.2|-14.9|||Mixed Models Analysis|||||-14.9|-17.2|<0.001
71901761|NCT04184622|143325295|SUPERIORITY||LS Mean Difference (Net)|-16.5|||<|0.001|TWO_SIDED|95.0|-17.7|-15.4|||Mixed Models Analysis|||||-15.4|-17.7|<0.001
71901762|NCT04184622|143325296|SUPERIORITY||LS Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.6|2.9|||ANCOVA|||||2.9|1.6|<0.001
71901763|NCT04184622|143325297|SUPERIORITY||Estimate Difference|-22.7|||<|0.001|TWO_SIDED|95.0|-25.6|-19.8|||Mixed Models Analysis|||||-19.8|-25.6|<0.001
71901764|NCT04184622|143325298|SUPERIORITY||Estimate Difference|-4.91|||<|0.001|TWO_SIDED|95.0|-6.4|-3.41|||Mixed Models Analysis|||||-3.41|-6.40|<0.001
71901765|NCT04184622|143325299|SUPERIORITY||Estimate Difference|7.65|||<|0.001|TWO_SIDED|95.0|5.85|9.49|||Mixed Models Analysis|||||9.49|5.85|<0.001
71901766|NCT04184622|143325300|SUPERIORITY||LS Mean Difference (Net)|-6.8|||<|0.001|TWO_SIDED|95.0|-7.9|-5.7|||Mixed Models Analysis|||||-5.7|-7.9|<0.001
71901767|NCT04184622|143325301|SUPERIORITY||Estimate Difference|-41.2|||<|0.001|TWO_SIDED|95.0|-44.9|-37.3|||Mixed Models Analysis|||||-37.3|-44.9|<0.001
71901768|NCT04184622|143325302|SUPERIORITY||LS Mean Difference (Net)|-13.2|||<|0.0001|TWO_SIDED|95.0|-15.3|-11.1|||Mixed Models Analysis|||||-11.1|-15.3|<.0001
71901769|NCT04184622|143325302|SUPERIORITY||LS Mean Difference (Net)|-17.7|||<|0.0001|TWO_SIDED|95.0|-19.8|-15.7|||Mixed Models Analysis|||||-15.7|-19.8|<.0001
71901770|NCT04184622|143325302|SUPERIORITY||LS Mean Difference (Net)|-20.7|||<|0.0001|TWO_SIDED|95.0|-22.8|-18.6|||Mixed Models Analysis|||||-18.6|-22.8|<.0001
71901771|NCT04184622|143325303|SUPERIORITY||Hazard Ratio (HR)|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.13|||Regression, Cox|||||0.13|0.03|<0.0001
71901772|NCT04184622|143325304|SUPERIORITY||Hazard Ratio (HR)|0.12|||<|0.0001|TWO_SIDED|95.0|0.07|0.21|||Regression, Cox|||||0.21|0.07|<0.0001
71901773|NCT04184622|143325305|SUPERIORITY||LS Mean Difference (Net)|-5.1|||<|0.001|TWO_SIDED|95.0|-5.5|-4.6|||Mixed Models Analysis|||||-4.6|-5.5|<0.001
71901774|NCT04184622|143325305|SUPERIORITY||LS Mean Difference (Net)|-7.2|||<|0.001|TWO_SIDED|95.0|-7.7|-6.8|||Mixed Models Analysis|||||-6.8|-7.7|<0.001
71901775|NCT04184622|143325305|SUPERIORITY||LS Mean Difference (Net)|-7.7|||<|0.001|TWO_SIDED|95.0|-8.2|-7.3|||Mixed Models Analysis|||||-7.3|-8.2|<0.001
71901776|NCT04184622|143325306|SUPERIORITY||LS Mean Difference (Net)|-0.33|||<|0.001|TWO_SIDED|95.0|-0.36|-0.3|||Mixed Models Analysis|||||-0.30|-0.36|<0.001
71819596|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.156||0.1228|TWO_SIDED|95.0|-0.55|0.07|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.55|0.1228
71819597|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.152||0.0099|TWO_SIDED|95.0|-0.7|-0.1|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.10|-0.70|0.0099
71819598|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.164||0.2174|TWO_SIDED|95.0|-0.53|0.12|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.12|-0.53|0.2174
71819599|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.161||0.082|TWO_SIDED|95.0|-0.6|0.04|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.04|-0.60|0.0820
71819600|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.194||0.2642|TWO_SIDED|95.0|-0.6|0.17|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.60|0.2642
71819601|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.189||0.0718|TWO_SIDED|95.0|-0.72|0.03|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.72|0.0718
71819602|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.212||0.3055|TWO_SIDED|95.0|-0.64|0.2|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.64|0.3055
71901777|NCT04184622|143325306|SUPERIORITY||LS Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.45|-0.38|||Mixed Models Analysis|||||-0.38|-0.45|<0.001
71901778|NCT04184622|143325306|SUPERIORITY||LS Mean Difference (Net)|-0.44|||<|0.001|TWO_SIDED|95.0|-0.48|-0.41|||Mixed Models Analysis|||||-0.41|-0.48|<0.001
71901779|NCT04184622|143325307|SUPERIORITY||LS Mean Difference (Net)|-8.59|||<|0.001|TWO_SIDED|95.0|-9.97|-7.2|||Mixed Models Analysis|||||-7.20|-9.97|<0.001
71901780|NCT04184622|143325307|SUPERIORITY||LS Mean Difference (Net)|-10.59|||<|0.001|TWO_SIDED|95.0|-11.98|-9.21|||Mixed Models Analysis|||||-9.21|-11.98|<0.001
71901781|NCT04184622|143325307|SUPERIORITY||LS Mean Difference (Net)|-11.42|||<|0.001|TWO_SIDED|95.0|-12.8|-10.3|||Mixed Models Analysis|||||-10.30|-12.80|<0.001
71901782|NCT04184622|143325308|SUPERIORITY||Estimate Difference|-6.06|||<|0.001|TWO_SIDED|95.0|-8.32|-3.75|||Mixed Models Analysis|||||-3.75|-8.32|<0.001
71901783|NCT04184622|143325309|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-26.1|-20.4|||Mixed Models Analysis|||||-20.4|-26.1|<0.001
71901784|NCT04184622|143325310|SUPERIORITY||Estimate Difference|-11.3|||<|0.001|TWO_SIDED|95.0|-16.1|-6.2|||Mixed Models Analysis|||||-6.2|-16.1|<0.001
71901785|NCT04184622|143325311|SUPERIORITY||LS Mean Difference (Net)|-4.2|||<|0.001|TWO_SIDED|95.0|-5.0|-3.5|||Mixed Models Analysis|||||-3.5|-5.0|<0.001
71901786|NCT04184622|143325312|SUPERIORITY||Odds Ratio (OR)|29.79|||<|0.0001|TWO_SIDED|95.0|17.73|50.05|||Regression, Logistic|||||50.05|17.73|<.0001
71901787|NCT04184622|143325312|SUPERIORITY||Odds Ratio (OR)|35.05|||<|0.0001|TWO_SIDED|95.0|20.63|59.53|||Regression, Logistic|||||59.53|20.63|<.0001
71901788|NCT04184622|143325312|SUPERIORITY||Odds Ratio (OR)|55.05|||<|0.0001|TWO_SIDED|95.0|29.61|102.34|||Regression, Logistic|||||102.34|29.61|<.0001
71901789|NCT04184622|143325313|SUPERIORITY||LS Mean Difference (Net)|7.7|||<|0.001|TWO_SIDED|95.0|5.6|9.8|||ANCOVA|||||9.8|5.6|<0.001
71901790|NCT04184622|143325313|SUPERIORITY||LS Mean Difference (Net)|10.7|||<|0.001|TWO_SIDED|95.0|8.6|12.8|||ANCOVA|||||12.8|8.6|<0.001
71901791|NCT04184622|143325313|SUPERIORITY||LS Mean Difference (Net)|11.7|||<|0.001|TWO_SIDED|95.0|9.6|13.8|||ANCOVA|||||13.8|9.6|<0.001
71819603|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.202||0.3533|TWO_SIDED|95.0|-0.59|0.21|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.21|-0.59|0.3533
71819604|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.193||0.4514|TWO_SIDED|95.0|-0.53|0.24|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.53|0.4514
71819605|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.191||0.4907|TWO_SIDED|95.0|-0.51|0.25|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.51|0.4907
71819606|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.151||0.6949|TWO_SIDED|95.0|-0.36|0.24|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.36|0.6949
71819607|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.147||0.467|TWO_SIDED|95.0|-0.4|0.18|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.40|0.4670
71819608|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.16||0.6556|TWO_SIDED|95.0|-0.39|0.25|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.25|-0.39|0.6556
71819609|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9272|TWO_SIDED|95.0|-0.32|0.29|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.29|-0.32|0.9272
71819610|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.164||0.1395|TWO_SIDED|95.0|-0.57|0.08|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.57|0.1395
71819611|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.159||0.2601|TWO_SIDED|95.0|-0.5|0.14|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.50|0.2601
71819612|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.158||0.5626|TWO_SIDED|95.0|-0.4|0.22|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.40|0.5626
71851187|NCT02312258|143216434|SUPERIORITY||Hazard Ratio (HR)|1.537|||=|0.398|TWO_SIDED|95.0|0.563|4.194|||Log Rank|||PFS for Participants with Known MRD- at Study Entry|"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|4.194|0.563|=0.398
71901792|NCT00769704|143325315|SUPERIORITY_OR_OTHER||Treatment Difference|14.1|||<|0.0001|TWO_SIDED|95.0|9.3|19.0|||Fisher Exact|||The null hypothesis was that there was no difference in the durable response rate between the talimogene laherparepvec and control arms. Study success was defined as the rejection of this hypothesis such that talimogene laherparepvec was found to be superior to GM-CSF using the 2-sided Fisher's exact test, with a p-value of ≤ 0.0488.||19.0|9.3|<0.0001
71851188|NCT02312258|143216434|SUPERIORITY||Hazard Ratio (HR)|10.173|||=|0.012|TWO_SIDED|95.0|1.194|86.649|||Log Rank|||OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|86.649|1.194|=0.012
71851189|NCT02312258|143216436|SUPERIORITY||Hazard Ratio (HR)|1.011|||=|0.963|TWO_SIDED|95.0|0.631|1.621|||Log Rank||||"P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.621|0.631|=0.963
71901793|NCT00769704|143325316|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0511|TWO_SIDED|95.0|0.62|1.0|||Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.|The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.||1.00|0.62|0.0511
71901794|NCT00769704|143325317|SUPERIORITY_OR_OTHER||Treatment Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.4|27.1||Descriptive|Fisher Exact|||||27.1|14.4|<0.0001
71901795|NCT00769704|143325318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.0868|TWO_SIDED|95.0|0.14|1.18||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average duration of response for talimogene laherparepvec relative to GM-CSF.|||1.18|0.14|0.0868
71901796|NCT00769704|143325319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.202|TWO_SIDED|95.0|0.3|1.3||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \> 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.|||1.30|0.30|0.2020
71901797|NCT00769704|143325320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.32|0.54||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.|||0.54|0.32|<0.0001
71901798|NCT00769704|143325321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.005|TWO_SIDED|95.0|0.13|0.73||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.|||0.73|0.13|0.0050
71901799|NCT01617681|143325327|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.96||0.0096|TWO_SIDED|95.0|-13.86|-2.01|||ANCOVA|||||-2.01|-13.86|0.0096
71901800|NCT01617681|143325327|OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|2.07||0.6531|TWO_SIDED|95.0|-5.07|3.2|||ANCOVA|||||3.20|-5.07|0.6531
71901801|NCT01617681|143325328|OTHER||Mean Difference (Net)|-7.9|STANDARD_ERROR_OF_MEAN|2.54||0.003|TWO_SIDED|95.0|-12.94|-2.78|||ANCOVA|||||-2.78|-12.94|0.0030
71901802|NCT01617681|143325328|OTHER||Mean Difference (Net)|-5.4|STANDARD_ERROR_OF_MEAN|1.8||0.0042|TWO_SIDED|95.0|-8.98|-1.77|||ANCOVA|||||-1.77|-8.98|0.0042
71901803|NCT01617681|143325329|OTHER||Odds Ratio (OR)|1.68||||0.411|TWO_SIDED|95.0|0.49|5.8|||ANCOVA|||||5.8|0.49|0.411
71901804|NCT01617681|143325329|OTHER||Odds Ratio (OR)|1.45||||0.5443|TWO_SIDED|95.0|0.44|4.79|||ANCOVA|||||4.79|0.44|0.5443
71901805|NCT01617681|143325330|OTHER||Odds Ratio (OR)|0.517||||0.2624|TWO_SIDED|95.0|0.16|1.64|||ANCOVA|||||1.64|0.16|0.2624
71901806|NCT01883440|143325345|SUPERIORITY_OR_OTHER||||||<|0.037|TWO_SIDED||||||Mixed Models Analysis|Linear mixed model||||||<0.037
71901807|NCT01883440|143325346|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED||||||Mixed Models Analysis|||In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.||||0.381
71901808|NCT03696758|143325347|OTHER|Descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
71901809|NCT03696758|143325348|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
71901810|NCT03696758|143325349|OTHER|descriptive statistics||||||0.004||||||p value is 0.004 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.004
71901811|NCT03696758|143325350|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.1
71901812|NCT03696758|143325351|OTHER|Descriptive statistics||||||0.09||||||p value is 0.09 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.09
71901813|NCT03696758|143325352|OTHER|Descriptive statistics||||||0.1||||||p value is 0.10 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.10
71901814|NCT03696758|143325353|OTHER|Descriptive statistics||||||0.82||||||p value is 0.82 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.82
71901815|NCT03696758|143325354|OTHER|Descriptive statistics||||||0.3||||||p value is 0.30 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.30
71901816|NCT03696758|143325355|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
71901817|NCT03696758|143325356|OTHER|Descriptive statistics||||||0.36||||||p value is 0.36 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.36
71901818|NCT03696758|143325357|OTHER|Descriptive statistics||||||0.65||||||P-Value is 0.65 for 'Pre-Metoprolol' vs 'post-Metoprolol' subgroup|Wilcoxon Signed Rank Test|||||||0.65
71901819|NCT03696758|143325358|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
71901820|NCT03696758|143325359|OTHER|Descriptive statistics||||||0.43||||||P-Value is 0.43 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.43
71901821|NCT03696758|143325360|OTHER|Descriptive statistics||||||0.66||||||P-Value is 0.66 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.66
71901822|NCT03696758|143325361|OTHER|Descriptive statistics||||||0.13||||||P-Value is 0.13 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.13
71901823|NCT03696758|143325362|OTHER|Descriptive statistics||||||0.57||||||P-Value is 0.57 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.57
71901824|NCT03696758|143325363|OTHER|Descriptive statistics||||||0.25||||||P-Value is 0.25 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.25
71901825|NCT03696758|143325364|OTHER|Descriptive statistics||||||0.07||||||P-Value is 0.07 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.07
71901826|NCT03696758|143325365|OTHER|Descriptive statistics||||||0.36||||||P-Value is 0.36 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.36
71901827|NCT03696758|143325366|OTHER|Descriptive statistics||||||0.91||||||P-Value is 0.91 for 'Pre-Sildenafil' vs 'Post-Sildenafil' subgroup|Wilcoxon Signed Rank Test|||||||0.91
71901828|NCT01856595|143325409|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-2.77|STANDARD_ERROR_OF_MEAN|8.532||0.7457|TWO_SIDED|90.0|-16.93|11.38||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||11.38|-16.93|0.7457
71901829|NCT01856595|143325409|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|8.334||0.0108|TWO_SIDED|90.0|-35.47|-7.81||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-7.81|-35.47|0.0108
71901830|NCT01856595|143325409|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-26.59|STANDARD_ERROR_OF_MEAN|8.309||0.0018|TWO_SIDED|90.0|-40.38|-12.8||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-12.80|-40.38|0.0018
71901831|NCT01856595|143325409|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-32.33|STANDARD_ERROR_OF_MEAN|8.038||0.0001|TWO_SIDED|90.0|-45.66|-18.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-18.99|-45.66|0.0001
71901832|NCT01856595|143325409|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-42.39|STANDARD_ERROR_OF_MEAN|8.34|<|0.0001|TWO_SIDED|90.0|-56.23|-28.55||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-28.55|-56.23|<0.0001
71901833|NCT01856595|143325410|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|10.47|STANDARD_ERROR_OF_MEAN|9.621||0.279|TWO_SIDED|90.0|-5.5|26.43||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||26.43|-5.50|0.2790
71901834|NCT01856595|143325410|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-19.33|STANDARD_ERROR_OF_MEAN|8.777||0.0299||90.0|-33.89|-4.76||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-4.76|-33.89|0.0299
71819613|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.153||0.4622|TWO_SIDED|95.0|-0.42|0.19|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.42|0.4622
71901835|NCT01856595|143325411|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-29.43|STANDARD_ERROR_OF_MEAN|7.609||0.0005|TWO_SIDED|90.0|-42.28|-16.57||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||-16.57|-42.28|0.0005
71901836|NCT01856595|143325411|SUPERIORITY_OR_OTHER||Least Square Mean Difference (Net)|-11.89|STANDARD_ERROR_OF_MEAN|7.321||0.1133|TWO_SIDED|90.0|-24.26|0.48||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.48|-24.26|0.1133
71819614|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.151||0.2858|TWO_SIDED|95.0|-0.46|0.14|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.46|0.2858
71819615|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.146||0.5369|TWO_SIDED|95.0|-0.38|0.2|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.38|0.5369
71819616|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.151|TWO_SIDED|95.0|-0.52|0.08|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.52|0.1510
71819617|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.146||0.5107|TWO_SIDED|95.0|-0.38|0.19|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.38|0.5107
71819618|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.151||0.3301|TWO_SIDED|95.0|-0.45|0.15|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.45|0.3301
71819619|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.147||0.5139|TWO_SIDED|95.0|-0.39|0.19|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.39|0.5139
71819620|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.144||0.4073|TWO_SIDED|95.0|-0.4|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.40|0.4073
71819621|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4649|TWO_SIDED|95.0|-0.38|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.38|0.4649
71819622|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.141||0.6926|TWO_SIDED|95.0|-0.34|0.22|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.34|0.6926
71819623|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.137||0.726|TWO_SIDED|95.0|-0.22|0.32|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.32|-0.22|0.7260
71819624|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.136||0.1486|TWO_SIDED|95.0|-0.47|0.07|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.47|0.1486
71819625|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.133||0.48|TWO_SIDED|95.0|-0.36|0.17|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.36|0.4800
71819626|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.177||0.7792|TWO_SIDED|95.0|-0.4|0.3|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.30|-0.40|0.7792
71819627|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.171||0.8644|TWO_SIDED|95.0|-0.31|0.37|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.31|0.8644
71819628|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.158||0.7994|TWO_SIDED|95.0|-0.27|0.35|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.35|-0.27|0.7994
71819629|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|0.152||0.0811|TWO_SIDED|95.0|-0.03|0.57|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.57|-0.03|0.0811
71819630|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.144||0.6978|TWO_SIDED|95.0|-0.34|0.23|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.23|-0.34|0.6978
71819631|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.141||0.9749|TWO_SIDED|95.0|-0.28|0.28|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.28|-0.28|0.9749
71819632|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.081||0.3158|TWO_SIDED|95.0|-0.08|0.24|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.24|-0.08|0.3158
71851190|NCT02312258|143216440|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.387|0.727|||Log Rank|||PFS Based on Frailty Status of Fit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|0.727|0.387|<0.001
71851191|NCT02312258|143216440|SUPERIORITY||Hazard Ratio (HR)|0.746|||=|0.098|TWO_SIDED|95.0|0.526|1.058|||Log Rank|||PFS Based on Frailty Status of Unfit|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.058|0.526|=0.098
71901837|NCT01856595|143325412|SUPERIORITY_OR_OTHER||Ratio|0.99|STANDARD_ERROR_OF_MEAN|1.066||0.853|TWO_SIDED|90.0|0.89|1.1||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.89|0.8530
71901838|NCT01856595|143325412|SUPERIORITY_OR_OTHER||Ratio|0.86|STANDARD_ERROR_OF_MEAN|1.065||0.0172|TWO_SIDED|90.0|0.77|0.95||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.95|0.77|0.0172
71901839|NCT01856595|143325412|SUPERIORITY_OR_OTHER||Ratio|0.85|STANDARD_ERROR_OF_MEAN|1.064||0.0106|TWO_SIDED|90.0|0.77|0.94||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.94|0.77|0.0106
71901840|NCT01856595|143325412|SUPERIORITY_OR_OTHER||Ratio|0.82|STANDARD_ERROR_OF_MEAN|1.062||0.0012|TWO_SIDED|90.0|0.74|0.9||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.90|0.74|0.0012
71901841|NCT01856595|143325412|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.065|<|0.0001|TWO_SIDED|90.0|0.69|0.85||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.85|0.69|<0.0001
71901842|NCT01856595|143325413|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.075||0.7804|TWO_SIDED|90.0|0.87|1.1||Two-sided p-values are from analysis of ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.10|0.87|0.7804
71901843|NCT01856595|143325413|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.068||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
71901844|NCT01856595|143325414|SUPERIORITY_OR_OTHER||Ratio|0.77|STANDARD_ERROR_OF_MEAN|1.083||0.0027|TWO_SIDED|90.0|0.68|0.88||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.88|0.68|0.0027
71901845|NCT01856595|143325414|SUPERIORITY_OR_OTHER||Ratio|0.88|STANDARD_ERROR_OF_MEAN|1.079||0.0908|TWO_SIDED|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.00|0.77|0.0908
71901846|NCT01856595|143325418|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.123||0.8723|TWO_SIDED|90.0|0.81|1.19||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.19|0.81|0.8723
71901847|NCT01856595|143325418|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.124||0.5158|TWO_SIDED|90.0|0.76|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.76|0.5158
71901848|NCT01856595|143325418|SUPERIORITY_OR_OTHER||Ratio|0.83|STANDARD_ERROR_OF_MEAN|1.126||0.1258|TWO_SIDED|90.0|0.68|1.01||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.01|0.68|0.1258
71901849|NCT01856595|143325418|SUPERIORITY_OR_OTHER||Ratio|0.89|STANDARD_ERROR_OF_MEAN|1.115||0.2883|TWO_SIDED|90.0|0.74|1.07||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.07|0.74|0.2883
71901850|NCT01856595|143325418|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.12||0.8437|TWO_SIDED|90.0|0.81|1.18||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.18|0.81|0.8437
71901851|NCT01856595|143325419|SUPERIORITY_OR_OTHER||Ratio|1.12|STANDARD_ERROR_OF_MEAN|1.154||0.4405|TWO_SIDED|90.0|0.88|1.42||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.42|0.88|0.4405
71901852|NCT01856595|143325419|SUPERIORITY_OR_OTHER||Ratio|1.09|STANDARD_ERROR_OF_MEAN|1.146||0.5178|TWO_SIDED|90.0|0.87|1.37||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.37|0.87|0.5178
71901853|NCT01856595|143325420|SUPERIORITY_OR_OTHER||Ratio|0.69|STANDARD_ERROR_OF_MEAN|1.181||0.034|TWO_SIDED|90.0|0.52|0.92||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||0.92|0.52|0.0340
71901854|NCT01856595|143325420|SUPERIORITY_OR_OTHER||Ratio|1.2|STANDARD_ERROR_OF_MEAN|1.173||0.2519|TWO_SIDED|90.0|0.92|1.58||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.58|0.92|0.2519
71901855|NCT01856595|143325421|SUPERIORITY_OR_OTHER||Ratio|1.06|STANDARD_ERROR_OF_MEAN|1.079||0.4579|TWO_SIDED|90.0|0.93|1.2||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.20|0.93|0.4579
71901856|NCT01856595|143325421|SUPERIORITY_OR_OTHER||Ratio|0.98|STANDARD_ERROR_OF_MEAN|1.079||0.8144|TWO_SIDED|90.0|0.87|1.11||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.11|0.87|0.8144
71901857|NCT01856595|143325421|SUPERIORITY_OR_OTHER||Ratio|0.93|STANDARD_ERROR_OF_MEAN|1.082||0.3425|TWO_SIDED|90.0|0.81|1.06||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.06|0.81|0.3425
71901858|NCT01856595|143325421|SUPERIORITY_OR_OTHER||Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.076||0.967|TWO_SIDED|90.0|0.88|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.13|0.88|0.9670
71901859|NCT01856595|143325421|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.079||0.319|TWO_SIDED|90.0|0.95|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.95|0.3190
71901860|NCT01856595|143325422|SUPERIORITY_OR_OTHER||Ratio|1.14|STANDARD_ERROR_OF_MEAN|1.095||0.1617|TWO_SIDED|90.0|0.98|1.32||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.32|0.98|0.1617
71901861|NCT01856595|143325422|SUPERIORITY_OR_OTHER||Ratio|1.08|STANDARD_ERROR_OF_MEAN|1.084||0.3703|TWO_SIDED|90.0|0.94|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.23|0.94|0.3703
71901862|NCT01856595|143325423|SUPERIORITY_OR_OTHER||Ratio|0.95|STANDARD_ERROR_OF_MEAN|1.119||0.6833|TWO_SIDED|90.0|0.79|1.15||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.15|0.79|0.6833
71901863|NCT01856595|143325423|SUPERIORITY_OR_OTHER||Ratio|1.18|STANDARD_ERROR_OF_MEAN|1.112||0.1318|TWO_SIDED|90.0|0.98|1.41||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.||1.41|0.98|0.1318
71901864|NCT00458406|143325467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||95.0|||||t-test, 2 sided|||"We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~Description of power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% confidence interval (CI) for the difference between the 2 means had a range of 1.282 standard deviation (SD)."||||0.512
71901865|NCT00458406|143325468|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
71901866|NCT00458406|143325469|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
71901867|NCT00458406|143325470|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Chi-squared|||"Chi-Square test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
71901868|NCT00458406|143325471|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.||||>0.05
71901869|NCT00458406|143325471|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||<0.05
71901870|NCT00458406|143325473|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
71901871|NCT00458406|143325474|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."||||>0.05
71901872|NCT03161938|143325476|SUPERIORITY||Odds Ratio (OR)|0.508||||0.248|TWO_SIDED|95.0|0.159|1.62|||Chi-squared, Corrected|||Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.||1.620|0.159|0.248
71901873|NCT03161938|143325477|SUPERIORITY|||||||0.519|||||||Wilcoxon (Mann-Whitney)|||||||0.519
71901874|NCT03161938|143325478|SUPERIORITY|||||||0.468|||||||Wilcoxon (Mann-Whitney)|||||||0.468
71901875|NCT03161938|143325479|SUPERIORITY|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||Maximal pain||||0.913
71901876|NCT03161938|143325479|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||Average pain||||0.722
71901877|NCT03161938|143325480|SUPERIORITY||Odds Ratio (OR)|1.19||||0.768|TWO_SIDED|95.0|0.374|3.793|||Chi-squared, Corrected|||||3.793|0.374|0.768
71901878|NCT03161938|143325481|SUPERIORITY|||||||0.133|||||||Regression, Linear|||||||0.133
71819633|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.079||0.1901|TWO_SIDED|95.0|-0.05|0.26|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.05|0.1901
71901879|NCT03161938|143325482|SUPERIORITY|||||||0.768||||||Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)|Chi-squared, Corrected|||Day 0||||0.768
71901880|NCT03161938|143325482|SUPERIORITY|||||||0.376|||||||Chi-squared, Corrected|||Day 1||||0.376
71901881|NCT03161938|143325482|SUPERIORITY|||||||0.59|||||||Chi-squared, Corrected|||Day 2||||0.590
71901882|NCT03161938|143325482|SUPERIORITY|||||||0.32|||||||Chi-squared, Corrected|||Day 3||||0.320
71901883|NCT03161938|143325482|SUPERIORITY|||||||0.666|||||||Chi-squared, Corrected|||day 4||||0.666
71901884|NCT03161938|143325483|SUPERIORITY||||||>|0.999|||||||Chi-squared, Corrected|||day 0||||>0.999
71901885|NCT03161938|143325483|SUPERIORITY|||||||0.154|||||||Chi-squared, Corrected|||day 1||||0.154
71901886|NCT03161938|143325483|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 2||||0.447
71901887|NCT03161938|143325483|SUPERIORITY|||||||0.678|||||||Chi-squared, Corrected|||day 3||||0.678
71901888|NCT03161938|143325483|SUPERIORITY|||||||0.604|||||||Chi-squared, Corrected|||day 4||||0.604
71901889|NCT03161938|143325484|SUPERIORITY|||||||0.075|||||||Chi-squared, Corrected|||day 0, sadness||||0.075
71901890|NCT03161938|143325484|SUPERIORITY|||||||0.447|||||||Chi-squared, Corrected|||day 0, restlessness||||0.447
71901891|NCT03161938|143325484|SUPERIORITY|||||||0.703|||||||Chi-squared, Corrected|||Day 0, fatigue||||0.703
71901892|NCT03161938|143325484|SUPERIORITY|||||||0.731|||||||Chi-squared, Corrected|||Day 1, sadness||||0.731
71901893|NCT03161938|143325484|SUPERIORITY|||||||0.052|||||||Chi-squared, Corrected|||Day 1, restlessness||||0.052
71901894|NCT03161938|143325484|SUPERIORITY|||||||0.807|||||||Chi-squared, Corrected|||Day 1, fatigue||||0.807
71901895|NCT03161938|143325484|SUPERIORITY|||||||0.371|||||||Chi-squared, Corrected|||Day 2, sadness||||0.371
71901896|NCT03161938|143325484|SUPERIORITY|||||||0.064|||||||Chi-squared, Corrected|||Day 2, restlessness||||0.064
71901897|NCT03161938|143325484|SUPERIORITY|||||||0.11|||||||Chi-squared, Corrected|||day 2, fatigue||||0.110
71901898|NCT03161938|143325484|SUPERIORITY|||||||0.531|||||||Chi-squared, Corrected|||Day 3, sadness||||0.531
71901899|NCT03161938|143325484|SUPERIORITY|||||||0.954|||||||Chi-squared, Corrected|||Day 3, restlessness||||0.954
71901900|NCT03161938|143325484|SUPERIORITY|||||||0.526|||||||Chi-squared, Corrected|||Day 3, fatigue||||0.526
71901901|NCT03161938|143325484|SUPERIORITY|||||||0.491|||||||Chi-squared, Corrected|||Day 4, sadness||||0.491
71901902|NCT03161938|143325484|SUPERIORITY|||||||0.042|||||||Chi-squared, Corrected|||Day 4, restlessness||||0.042
71901903|NCT03161938|143325484|SUPERIORITY|||||||0.097|||||||Chi-squared, Corrected|||Day 4, fatigue||||0.097
71901904|NCT03161938|143325485|SUPERIORITY|||||||0.613|||||||Chi-squared, Corrected|||||||0.613
71901905|NCT01071044|143325529|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||ANOVA|These data were initially analyzed with a one-way ANOVA.||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||.005
71901906|NCT01071044|143325530|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.008
71901907|NCT01071044|143325531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.183||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.183
71901908|NCT01071044|143325532|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.046
71901909|NCT01071044|143325533|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.219
71901910|NCT01071044|143325534|SUPERIORITY_OR_OTHER_LEGACY|||||||0.038||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.038
71901911|NCT01071044|143325535|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.||||0.022
71901912|NCT00069576|143325539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.14|TWO_SIDED|97.0|0.72|1.07|||Chi-squared|||For Total Composite End Point||1.07|0.72|0.14
71901913|NCT00069576|143325539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.75|TWO_SIDED|97.0|0.73|1.53|||Chi-squared|||Analysis for Hypoglycemia||1.53|0.73|0.75
71901914|NCT00069576|143325539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.74||||0.12|TWO_SIDED|97.0|0.49|1.12|||Chi-squared|||Analysis for hyperbilirubinemia||1.12|0.49|0.12
71901915|NCT00069576|143325539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.07|TWO_SIDED|97.0|0.57|1.05|||Chi-squared|||Analysis for elevated cord-blood C-peptide level||1.05|0.57|0.07
71901916|NCT00069576|143325539|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.33|TWO_SIDED|97.0|0.1|2.2|||Chi-squared|||Analysis for birth trauma||2.20|0.10|0.33
71901917|NCT00069576|143325540|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.68|1.28||||||||1.28|0.68|
71901918|NCT00069576|143325541|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.001|TWO_SIDED|97.0|0.32|0.76|||Chi-squared|||||0.76|0.32|<0.001
71901919|NCT00069576|143325542|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.001|TWO_SIDED|97.0|0.26|0.66|||Chi-squared|||||0.66|0.26|<0.001
71901920|NCT00069576|143325543|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.27|TWO_SIDED|97.0|0.53|1.23|||Chi-squared|||||1.23|0.53|0.27
71901921|NCT00069576|143325544|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71901922|NCT00069576|143325545|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.49|TWO_SIDED|97.0|0.7|1.99|||Chi-squared|||||1.99|0.70|0.49
71901923|NCT00069576|143325546|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71901924|NCT00069576|143325547|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.19|TWO_SIDED|97.0|0.51|1.18|||Chi-squared|||||1.18|0.51|0.19
71901925|NCT00069576|143325548|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77||||0.32|TWO_SIDED|97.0|0.44|1.36|||Chi-squared|||||1.36|0.44|0.32
71901926|NCT00069576|143325549|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.33|TWO_SIDED|97.0|0.26|1.67|||Chi-squared|||||1.67|0.26|0.33
71901927|NCT00069576|143325550|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|97.0|0.81|1.29|||Chi-squared|||||1.29|0.81|0.86
71901928|NCT00069576|143325551|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.02|TWO_SIDED|97.0|0.64|0.99|||Chi-squared|||||0.99|0.64|0.02
71901929|NCT00069576|143325552|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.02|TWO_SIDED|97.0|0.14|0.97|||Chi-squared|||||0.97|0.14|0.02
71901930|NCT00069576|143325553|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.46||||0.02|TWO_SIDED|97.0|0.22|0.97|||Chi-squared|||||0.97|0.22|0.02
71901931|NCT00069576|143325554|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.01|TWO_SIDED|97.0|0.42|0.96|||Chi-squared|||||0.96|0.42|0.01
71901932|NCT00069576|143325555|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71901933|NCT00069576|143325556|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71901934|NCT00069576|143325557|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.71|1.1||||||||1.10|0.71|
71901935|NCT00069576|143325558|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.65|1.69||||||||1.69|0.65|
71901936|NCT00069576|143325559|SUPERIORITY||Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.74|2.05||||||||2.05|0.74|
71901937|NCT00069576|143325560|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
71901938|NCT00069576|143325561|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71901939|NCT04525222|143325563|OTHER||Slope|0.42||||0.0088|TWO_SIDED|95.0|0.1|0.74|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||"Treatment satisfaction items are reported on a Likert-type scale, with response choices ranging from not at all to very much. We used a linear regression adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), and Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5) to test for differences between arms."||0.74|0.10|0.0088
71901940|NCT04525222|143325564|OTHER||Slope|2.92||||0.75|TWO_SIDED|95.0|-15.22|21.07|||Negative Binomial Regression|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||21.07|-15.22|0.75
71901941|NCT04525222|143325565|OTHER||Odds Ratio (OR)|1.33||||0.55|TWO_SIDED|95.0|0.5|3.48|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.48|0.5|0.55
71901942|NCT04525222|143325566|OTHER||Odds Ratio (OR)|1.63||||0.17|TWO_SIDED|95.0|0.8|3.32|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking \<20 Cigs/ \>=20 Cigs, Baseline Depression Severity PHQ-8\<5 / PHQ-8\>=5||||3.32|0.80|0.17
71901943|NCT04525222|143325567|OTHER||Odds Ratio (OR)|1.63||||0.25|TWO_SIDED|95.0|0.7|3.81|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.81|0.70|0.25
71901944|NCT04525222|143325568|OTHER||Odds Ratio (OR)|1.88||||0.07|TWO_SIDED|95.0|0.94|3.72||Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)|Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.72|0.94|0.07
71901945|NCT04525222|143325569|OTHER||Odds Ratio (OR)|2.42||||0.04|TWO_SIDED|95.0|1.0|5.85|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||5.85|1.00|0.04
71851192|NCT02312258|143216440|SUPERIORITY||Hazard Ratio (HR)|0.733|||=|0.147|TWO_SIDED|95.0|0.481|1.117|||Log Rank|||PFS Based on Frailty Status of Frail|"P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization.~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\<75 vs \>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.117|0.481|=0.147
71901946|NCT04525222|143325570|OTHER||Odds Ratio (OR)|1.47||||0.25|TWO_SIDED|95.0|0.75|2.89|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||2.89|0.75|0.25
71901947|NCT04525222|143325571|OTHER||Odds Ratio (OR)|1.78||||0.17|TWO_SIDED|95.0|0.77|4.12|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.12|0.77|0.17
71901948|NCT04525222|143325572|OTHER||Odds Ratio (OR)|1.91||||0.15|TWO_SIDED|95.0|0.77|4.73|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.73|0.77|0.15
71901949|NCT04525222|143325573|OTHER||Odds Ratio (OR)|1.25||||0.68|TWO_SIDED|95.0|0.41|3.86|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.86|0.41|0.68
71901950|NCT04525222|143325574|OTHER||Odds Ratio (OR)|1.63||||0.21|TWO_SIDED|95.0|0.75|3.46|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||3.46|0.75|0.21
71901951|NCT04525222|143325575|OTHER||Odds Ratio (OR)|1.63||||0.3|TWO_SIDED|95.0|0.63|4.19|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.19|0.63|0.30
71901952|NCT04525222|143325576|OTHER||Slope|-1.68||||0.0072|TWO_SIDED|95.0|-2.9|-0.46|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||-0.46|-2.90|.0072
71901953|NCT04525222|143325577|OTHER||Odds Ratio (OR)|1.829||||0.177|TWO_SIDED|95.0|0.77|4.344|||Regression, Logistic|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression Severity (PHQ-8\<5 / PHQ-8\>=5)||||4.344|0.770|0.1770
71901954|NCT04525222|143325578|OTHER||Slope|3.62||||0.0025|TWO_SIDED|95.0|1.28|5.95|||Regression, Linear|Adjusting for Treatment Arm, Sex Assigned at Birth, Baseline Level of Smoking (\<20 Cigs/ \>=20 Cigs), Baseline Depression, Baseline Activation Score||||5.95|1.28|0.0025
71901955|NCT00320385|143325584|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.008|TWO_SIDED|95.0|0.57|0.93|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||0.93|0.57|0.008
71901956|NCT00320385|143325585|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.106|TWO_SIDED|95.0|0.53|1.07|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.|||1.07|0.53|0.106
71901957|NCT00320385|143325586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.46|TWO_SIDED|95.0|0.6|3.9|||Fisher Exact||Responses were compared between treatment arms using stratified Fisher's exact tests.|||3.9|0.6|0.460
71901958|NCT00320385|143325587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.01|TWO_SIDED|95.0|1.2|4.5|||Fisher Exact||Clinical Benefit was compared between treatment arms using stratified Fisher's exact tests.|||4.5|1.2|0.010
71901959|NCT03382899|143325599|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7626|TWO_SIDED|95.0|0.5|2.5|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on interactive web response system (IWRS). 95% Confidence intervals (CIs) were estimated using the Clopper-Pearson method.|||2.5|0.5|0.7626
71901960|NCT03382899|143325600|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.263|TWO_SIDED|95.0|0.722|3.243|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.243|0.722|0.263
71901961|NCT03382899|143325601|SUPERIORITY||Hazard Ratio (HR)|0.975||||0.2|TWO_SIDED|95.0|0.571|1.663|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Kaplan-Meier method.|||1.663|0.571|0.20
71883059|NCT00385255|143285391|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+ Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|-1.67|||||TWO_SIDED|95.0|-2.96|-0.74||||||Difference in seroprotection rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-T antibody, one month post-Boostrix® vaccination.||-0.74|-2.96|
71901962|NCT03382899|143325602|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9418|TWO_SIDED|95.0|0.5|2.3|||Cochran-Mantel-Haenszel||Odds Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the Clopper-Pearson method.|||2.3|0.5|0.9418
71901963|NCT03382899|143325603|SUPERIORITY||Hazard Ratio (HR)|1.124||||0.8312|TWO_SIDED|95.0|0.384|3.289|||Log Rank||Hazard Ratio stratified by histology type, squamous versus non-squamous based on IWRS. 95% CIs were estimated using the methods of Brookmeyer and Crowley, and Greenwood, respectively.|||3.289|0.384|0.8312
71901964|NCT01355068|143325604|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.33|||||TWO_SIDED|90.0|97.85|104.94||||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||104.94|97.85|
71901965|NCT01355068|143325605|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|102.2|||||TWO_SIDED|90.0|97.18|107.47||||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.47|97.18|
71901966|NCT01355068|143325606|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Adjusted Means|101.43|||||TWO_SIDED|90.0|97.56|105.47||||||Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||105.47|97.56|
71901967|NCT00540449|143325614|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-0.4|||<|0.0001||95.0|-5.9|5.2||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.||5.2|-5.9|<0.0001
71901968|NCT00540449|143325615|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.3|||<|0.0001||95.0|-5.4|5.9|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||5.9|-5.4|<0.0001
71901969|NCT00540449|143325616|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-3.2||||0.0055||95.0|-9.4|3.1|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|||3.1|-9.4|0.0055
71901970|NCT00540449|143325617|NON_INFERIORITY_OR_EQUIVALENCE|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 - EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-1.7||||0.0013||95.0|-8.0|4.5|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.||||4.5|-8.0|0.0013
71901971|NCT00872170|143325623|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||This study had 80% power at level alpha=0.05 to detect a 60 m change in 6MWT among N=10 participants, assuming a 60 m standard deviation for 12-week change.||||0.97
71901972|NCT00872170|143325624|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
71901973|NCT00872170|143325625|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.005
71901974|NCT00872170|143325626|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
71901975|NCT00872170|143325627|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.05
71901976|NCT00872170|143325628|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.02
71901977|NCT00872170|143325629|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.04
71901978|NCT00872170|143325630|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.33
71901979|NCT00872170|143325631|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.18
71901980|NCT00872170|143325632|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.97
71901981|NCT00872170|143325633|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||||||0.96
71901982|NCT01721408|143325634|NON_INFERIORITY_OR_EQUIVALENCE|Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.|Difference in percentage|-6.7||||0.0008|TWO_SIDED|95.0|-12.0|-1.4|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||-1.4|-12.0|0.0008
71901983|NCT01721408|143325635|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
71901984|NCT01721408|143325636|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|TWO_SIDED|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.|||0.5|-15.2|0.0277
71901985|NCT01721408|143325638|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-6.0||||0.004|TWO_SIDED|95.0|-12.8|0.8|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.|||0.8|-12.8|0.0040
71901986|NCT02426658|143325639|SUPERIORITY|||||||0.7044|||||||Mixed Models Analysis|||||||0.7044
71901987|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.0||||0.9946|TWO_SIDED|95.0|0.83|1.2|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/ Placebo\].|Time to first vascular AE (SAF-M1)||1.20|0.83|0.9946
71901988|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.95||||0.7474|TWO_SIDED|95.0|0.72|1.27|||Regression, Cox|Cox regression of time to first vascular AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo. \[Treatment/Placebo\].|Time to first vascular AE (SAF-M2)||1.27|0.72|0.7474
71901989|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.03||||0.7943|TWO_SIDED|95.0|0.81|1.31|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment / Placebo\]|Time to first vascular AE (Trial NCT01131676, all empagliflozin (10 and 25 mg vs. Placebo))||1.31|0.81|0.7943
71679750|NCT02783729|142877142|SUPERIORITY||LSGM Ratio|0.83|||<|0.0001|TWO_SIDED|95.0|0.763|0.902||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 10 mg||0.902|0.763|< 0.0001
71901990|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.97||||0.8518|TWO_SIDED|95.0|0.69|1.36|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment / Placebo\].|Time to first vascular AE (Trial NCT03057951)||1.36|0.69|0.8518
71901991|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.93||||0.766|TWO_SIDED|95.0|0.56|1.53|||Regression, Cox|Cox regression for time to first vascular AE on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first vascular AE (Trial NCT03057977)||1.53|0.56|0.7660
71901992|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.15||||0.3612|TWO_SIDED|95.0|0.85|1.55|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M1)||1.55|0.85|0.3612
71901993|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.44||||0.161|TWO_SIDED|95.0|0.86|2.4|||Regression, Cox|Cox regression of time to first diabetic foot related AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first diabetic foot related AE (SAF-M2)||2.40|0.86|0.1610
71901994|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.02||||0.9128|TWO_SIDED|95.0|0.71|1.47|||Regression, Cox|Cox regression for time to first diabetic foot related AE on treatment. Cox regression model with a term for treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT01131676, all empagliflozin (10 and 25 mg) vs. Placebo)||1.47|0.71|0.9128
71901995|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.81||||0.5276|TWO_SIDED|95.0|0.43|1.54|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs. Placebo \[Treatment/Placebo\]|Time to first diabetic foot related AE (Trial NCT03057951)||1.54|0.43|0.5276
71901996|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|4.72||||0.0048|TWO_SIDED|95.0|1.6|13.87|||Regression, Cox|Cox regression for time to first diabetic foot related AE. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment / Placebo\]|Time to first diabetic foot related AE (Trial NCT03057977)||13.87|1.60|0.0048
71901997|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.89||||0.1526|TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox regression of time to first infections potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infections potentially related to LLA's (SAF-M1)||1.04|0.77|0.1526
71901998|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.96||||0.743|TWO_SIDED|95.0|0.76|1.21|||Regression, Cox|Cox regression of time to first infection potentially related to LLA's. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first infection potentially related to LLA's (SAF-M2)||1.21|0.76|0.7430
71901999|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.85||||0.1049|TWO_SIDED|95.0|0.69|1.04|||Regression, Cox|Cox regression for infections potentially related to LLA-on treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs. Placebo)||1.04|0.69|0.1049
71902000|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.89||||0.395|TWO_SIDED|95.0|0.67|1.17|||Regression, Cox|Cox regression for infections potentially related to LLA on treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057951)||1.17|0.67|0.3950
71902001|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.19||||0.4429|TWO_SIDED|95.0|0.76|1.87|||Regression, Cox|Cox regression for infections potentially related to LLA on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first infections potentially related to LLA (Trial NCT03057977)||1.87|0.76|0.4429
71902002|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.89||||0.3396|TWO_SIDED|95.0|0.7|1.13|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M1)||1.13|0.70|0.3396
71902003|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.7||||0.105|TWO_SIDED|95.0|0.46|1.08|||Regression, Cox|Cox regression of time to first wound infections. Cox regression with terms for study, baseline diabetes status and treatment|Comparison versus Placebo \[Treatment/Placebo\].|Time to first wound/infection (SAF-M2)||1.08|0.46|0.1050
71902004|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.0||||0.9919|TWO_SIDED|95.0|0.74|1.35|||Regression, Cox|Cox regression for time to first wound/infection on-treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.35|0.74|0.9919
71902005|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.79||||0.3634|TWO_SIDED|95.0|0.48|1.31|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057951)||1.31|0.48|0.3634
71902006|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.52||||0.1177|TWO_SIDED|95.0|0.23|1.18|||Regression, Cox|Cox regression for time to first wound/infection on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first wound/infection (Trial NCT03057977)||1.18|0.23|0.1177
71902007|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.0||||0.9992|TWO_SIDED|95.0|0.84|1.19|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M1)||1.19|0.84|0.9992
71902008|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.09||||0.6274|TWO_SIDED|95.0|0.78|1.52|||Regression, Cox|Cox regression of time to first nervous system disorder. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first nervous system disorder (SAF-M2)||1.52|0.78|0.6274
71902009|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|0.97||||0.7597|TWO_SIDED|95.0|0.79|1.19|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||1.19|0.79|0.7597
71902010|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.08||||0.7067|TWO_SIDED|95.0|0.74|1.57|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first nervous system disorder (Trial NCT03057951)||1.57|0.74|0.7067
71902011|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.12||||0.7404|TWO_SIDED|95.0|0.56|2.25|||Regression, Cox|Cox regression for time to first nervous system disorder on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|time to first nervous system disorder (Trial NCT03057977)||2.25|0.56|0.7404
71902012|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.21||||0.1765|TWO_SIDED|95.0|0.92|1.58|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M1)||1.58|0.92|0.1765
71902013|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.22||||0.1978|TWO_SIDED|95.0|0.9|1.66|||Regression, Cox|Cox regression of time to first volume depletion AE. Cox regression with terms for study, baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment/Placebo\].|Time to first volume depletion AE (SAF-M2)||1.66|0.90|0.1978
71902014|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.14||||0.6561|TWO_SIDED|95.0|0.64|2.05|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with a term for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT01131676, all Empagliflozin (10 mg and 25 mg) vs Placebo)||2.05|0.64|0.6561
71902015|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.29||||0.1699|TWO_SIDED|95.0|0.9|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057951)||1.87|0.90|0.1699
71679751|NCT02783729|142877142|SUPERIORITY||LSGM Ratio|0.882|||=|0.0176|TWO_SIDED|95.0|0.796|0.978||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.978|0.796|= 0.0176
71902016|NCT04937816|143325683|OTHER||Hazard Ratio (HR)|1.08||||0.7944|TWO_SIDED|95.0|0.62|1.87|||Regression, Cox|Cox regression for time to first volume depletion on-treatment. Cox regression model with terms for baseline diabetes status and treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Time to first volume depletion (Trial NCT03057977)||1.87|0.62|0.7944
71902017|NCT04937816|143325684|OTHER||Hazard Ratio (HR)|1.02||||0.9276|TWO_SIDED|95.0|0.73|1.42|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\].|||1.42|0.73|0.9276
71819634|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.073||0.7229|TWO_SIDED|95.0|-0.12|0.17|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.17|-0.12|0.7229
71851193|NCT02312258|143216440|SUPERIORITY||Hazard Ratio (HR)|0.897|||=|0.714|TWO_SIDED|95.0|0.502|1.602|||Log Rank|||OS Based on Frailty Status of Fit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.602|0.502|=0.714
71851194|NCT02312258|143216440|SUPERIORITY||Hazard Ratio (HR)|1.75|||=|0.124|TWO_SIDED|95.0|0.85|3.601|||Log Rank|||OS Based on Frailty Status of Unfit|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|3.601|0.850|=0.124
71851195|NCT02312258|143216440|SUPERIORITY||Hazard Ratio (HR)|0.854|||=|0.63|TWO_SIDED|95.0|0.448|1.627|||Log Rank|||OS Based on Frailty Status of Frail|"P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).~Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."|1.627|0.448|=0.630
71819635|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.071||0.2715|TWO_SIDED|95.0|-0.06|0.22|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.06|0.2715
71819636|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.5421|TWO_SIDED|95.0|-0.12|0.22|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.12|0.5421
71819637|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.083||0.7215|TWO_SIDED|95.0|-0.14|0.19|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.14|0.7215
71819638|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.098||0.2246|TWO_SIDED|95.0|-0.07|0.31|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.07|0.2246
71851196|NCT03905512|143216535|SUPERIORITY|Statistical significance was tested at a level of 0.05.||||||0.181|||||||Cochran-Mantel-Haenszel|||||||0.181
71851197|NCT00866619|143216545|SUPERIORITY|Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|55.8|||<|0.0001|TWO_SIDED|97.5|50.6|60.4|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[5-17M\] Group (HR1) divided by HR in control VeroRab Comparator \[5-17M\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||60.4|50.6|<0.0001
71902018|NCT04937816|143325684|OTHER||Hazard Ratio (HR)|0.85||||0.6205|TWO_SIDED|95.0|0.45|1.6|||Regression, Cox|Cox regression model with terms for study, baseline diabetes status and treatment.|Comparison versus placebo \[Treatment/Placebo\]|||1.60|0.45|0.6205
71819639|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.096||0.9671|TWO_SIDED|95.0|-0.19|0.19|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.19|0.9671
71902019|NCT04937816|143325684|OTHER||Hazard Ratio (HR)|1.09||||0.6768|TWO_SIDED|95.0|0.73|1.63|||Regression, Cox|Cox regression model with terms for treatment.|Comparison vs Placebo \[Treatment/Placebo\]|Empagliflozin (10 mg + 25 mg) versus Placebo.||1.63|0.73|0.6768
71902020|NCT04937816|143325684|OTHER||Hazard Ratio (HR)|0.73||||0.4294|TWO_SIDED|95.0|0.34|1.59|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||1.59|0.34|0.4294
71902021|NCT04937816|143325684|OTHER||Hazard Ratio (HR)|1.17||||0.7826|TWO_SIDED|95.0|0.39|3.47|||Regression, Cox|Cox regression model with terms for baseline diabetes status and treatment.|Comparison versus Placebo \[Treatment /Placebo\]|||3.47|0.39|0.7826
71902022|NCT05281523|143325693|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group.|Difference in Least Square Means|-0.6||||0.004|TWO_SIDED|95.0|-1.0|-0.2|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.2|-1.0|0.004
71902023|NCT05281523|143325694|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group.|Difference in Least Square Means|-0.25||||0.025|TWO_SIDED|95.0|-0.46|-0.03|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-0.03|-0.46|0.025
71902024|NCT05281523|143325695|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group.|Difference in Least Square Means|-0.18||||0.125|TWO_SIDED|95.0|-0.4|0.05|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||0.05|-0.40|0.125
71902025|NCT05281523|143325696|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, subgroup, visit by baseline, visit by treatment group, subgroup by treatment group and subgroup by visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.26||||0.007|TWO_SIDED|95.0|-0.45|-0.07|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 49 to Week 52 in participants with a diagnosis of CRSwNP||-0.07|-0.45|0.007
71902026|NCT05281523|143325697|OTHER|Analysis performed using an analysis of covariance model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region and previous surgery for nasal polyps. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level|Difference in Least Square Means|-3.2|||<|0.001|TWO_SIDED|95.0|-4.4|-2.0|||ANCOVA|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-4.4|<0.001
71902027|NCT05281523|143325698|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-9.9||||0.015|TWO_SIDED|95.0|-17.9|-2.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP||-2.0|-17.9|0.015
71902028|NCT05281523|143325699|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.24||||0.016|TWO_SIDED|95.0|-0.43|-0.04|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 21 to Week 24 in participants with a diagnosis of CRSwNP||-0.04|-0.43|0.016
71902029|NCT05281523|143325700|OTHER|Analysis performed using a repeated measures model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, visit, visit by baseline, and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.3||||0.066|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 26 in participants with a diagnosis of CRSwNP||0.0|-0.7|0.066
71902030|NCT05281523|143325701|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses.|Hazard Ratio (HR)|0.735||||0.128|TWO_SIDED|95.0|0.495|1.092|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.092|0.495|0.128
71902031|NCT05281523|143325702|OTHER|Cox Proportional Hazards Model with covariates of treatment, baseline total endoscopic nasal polyps score, baseline nasal obstruction score (VRS), log(e) baseline blood eosinophil count, region, study and previous surgery for nasal polyps. The covariate for study is removed for the individual-study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Hazard Ratio (HR)|0.713||||0.146|TWO_SIDED|95.0|0.453|1.124|||Cox Proportional Hazards Model|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||1.124|0.453|0.146
71902032|NCT05281523|143325703|OTHER|Logistic regression with covariates of treatment, number of courses of systemic CS in 12 months prior to screening for NP (0, 1,\>1), log(e) baseline blood eosinophil count, baseline total endoscopic NP score, baseline nasal obstruction score (VRS), region, study and previous surgery for NPs. The study covariate is removed for individual study analyses. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Odds Ratio (OR)|0.58||||0.006|TWO_SIDED|95.0|0.4|0.86|||Regression, Logistic|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis)||0.86|0.40|0.006
71902033|NCT05281523|143325704|OTHER|The pooled statistical analyses was performed using a Mixed Models Repeated Measures (MMRM) model with covariates of treatment group, baseline score, log(e) baseline blood eosinophil count, region, previous surgery for nasal polyps, study, visit and interaction terms for visit by baseline score and visit by treatment group. If the hierarchy is broken, subsequent endpoints were evaluated for nominal significance in a descriptive manner, using a 5% reference level.|Difference in Least Square Means|-0.75||||0.004|TWO_SIDED|95.0|-1.26|-0.25|||Mixed Models Analysis|||To assess the efficacy of depemokimab 100mg SC + SoC compared to placebo + SoC at Week 52 in participants with a diagnosis of CRSwNP (pooled analysis).||-0.25|-1.26|0.004
71902034|NCT05513391|143325705|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio was greater than (\>) 0.667 for each virus strain.|GMT Ratio|1.28|||||TWO_SIDED|95.0|0.948|1.73||||||Statistical analysis for A/H1N1||1.73|0.948|
71902035|NCT05513391|143325705|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|2.53|||||TWO_SIDED|95.0|1.93|3.3||||||Statistical analysis for A/H3N2||3.30|1.93|
71902036|NCT05513391|143325705|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|0.515|||||TWO_SIDED|95.0|0.397|0.668||||||Statistical analysis for B/Victoria||0.668|0.397|
71902037|NCT05513391|143325705|NON_INFERIORITY|Non inferiority for GMTs was demonstrated if the lower limit of the 2-sided 95% CI of the GMT ratio was \> 0.667 for each virus strain.|GMT Ratio|1.02|||||TWO_SIDED|95.0|0.799|1.3||||||Statistical analysis for B/Yamagata||1.30|0.799|
71902038|NCT05513391|143325706|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|7.1|||||TWO_SIDED|95.0|-1.55|15.7||||||Statistical analysis for A/H1N1||15.7|-1.55|
71902039|NCT05513391|143325706|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|15.4|||||TWO_SIDED|95.0|5.8|24.7||||||Statistical analysis for A/H3N2||24.7|5.80|
71902040|NCT05513391|143325706|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|-6.91|||||TWO_SIDED|95.0|-14.02|0.1||||||Statistical analysis for B/Victoria||0.10|-14.02|
71902041|NCT05513391|143325706|NON_INFERIORITY|Non-inferiority for SC was demonstrated if the lower limit of the 2-sided 95% CI was \> -10% for the 4 strains.|Difference in percentage of participants|5.81|||||TWO_SIDED|95.0|-1.99|13.6||||||Statistical analysis for B/Yamagata||13.6|-1.99|
71902042|NCT05299983|143325774|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
71902043|NCT05299983|143325775|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
71902044|NCT05299983|143325776|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||0.22
71902045|NCT05299983|143325777|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
71902046|NCT00074412|143325803|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
71902047|NCT00074412|143325803|SUPERIORITY_OR_OTHER_LEGACY||6 month Rate of Cum. HIV Infection (%)|2.4|||||TWO_SIDED|95.0|1.3|3.6|||Kaplan-Meier Method|||||3.6|1.3|
71679752|NCT02783729|142877142|SUPERIORITY||LSGM Ratio|0.811|||<|0.0001|TWO_SIDED|95.0|0.732|0.899||Based on MMRM model model with log transformation of sSOL and with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||0.899|0.732|< 0.0001
71902048|NCT00074412|143325803|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.973||||0.049||95.0||||P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.|Z-test|||Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. \& 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.||||0.049
71902049|NCT00074412|143325805|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|97.7|||||TWO_SIDED|95.0|96.6|98.8|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.8|96.6|
71902050|NCT00074412|143325805|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 6mon (%)|96.8|||||TWO_SIDED|95.0|95.5|98.0|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.||98.0|95.5|
71902051|NCT00074412|143325805|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.095||||0.274||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.||||0.274
71902052|NCT00074412|143325805|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|94.5|||||TWO_SIDED|95.0|92.9|96.2|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.||96.2|92.9|
71902053|NCT00074412|143325805|SUPERIORITY_OR_OTHER_LEGACY||Cum. Rate of HIV-free Survival 18mon (%)|93.3|||||TWO_SIDED|95.0|91.5|95.1|||Kaplan-Meier Method|||The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||95.1|91.5|
71902054|NCT00074412|143325805|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|0.988||||0.323||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.||||0.323
71902055|NCT00074412|143325806|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum HIV Infection (%)|2.2|||||TWO_SIDED|95.0|1.1|3.3|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||3.3|1.1|
71902056|NCT00074412|143325806|SUPERIORITY_OR_OTHER_LEGACY||18 mon. Rate of Cum. HIV Infection (%)|3.1|||||TWO_SIDED|95.0|1.9|4.4|||Kaplan-Meier Method|||The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.||4.4|1.9|
71902057|NCT00074412|143325806|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|1.081||||0.28||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.||||0.280
71902058|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.7|||||TWO_SIDED|95.0|2.0|7.4|||Kaplan-Meier Method|||||7.4|2.0|
71902059|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 18mon (%)|4.1|||||TWO_SIDED|95.0|2.7|5.6|||Kaplan-Meier Method|||||5.6|2.7|
71902060|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.247||||0.805||95.0||||P-value was not adjusted for interim analysis or multiple testing|Z-test|||The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.||||0.805
71902061|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.2|||||TWO_SIDED|95.0|0.4|2.0|||Kaplan-Meier Method|||||2.0|0.4|
71902062|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY||Cumulative Mortality Rate at 6mon (%)|1.1|||||TWO_SIDED|95.0|0.3|1.8|||Kaplan-Meier Method|||||1.8|0.3|
71902063|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY||Z statistic|-0.36||||0.719||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.||||0.719
71902064|NCT00074412|143325807|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||95.0|||||Log Rank|||We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.||||0.611
71902065|NCT00418834|143325808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-16.0|-11.7|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-11.7|-16.0|<0.001
71679753|NCT02783729|142877142|SUPERIORITY||LSM Difference|8.12|STANDARD_ERROR_OF_MEAN|4.484|=|0.0706|TWO_SIDED|95.0|-0.68|16.91||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||16.91|-0.68|= 0.0706
71851198|NCT00866619|143216546|SUPERIORITY|Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE \> 0.|Vaccine efficacy|31.315|||<|0.0001|TWO_SIDED|97.5|23.556|38.286|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus \[Hazard Ratio (HR) in GSK257049 \[6-12W\] Group (HR1) divided by HR in control Menjugate Comparator \[6-12W\] Group (HR2)\]; i. e. 1 - (HR1/HR2).||38.286|23.556|<0.0001
71851199|NCT00645411|143216612|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.85|||||TWO_SIDED|95.0|0.72|1.01|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay||1.01|0.72|
71851200|NCT00645411|143216612|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.59|||||TWO_SIDED|95.0|0.49|0.72|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||0.72|0.49|
71851201|NCT00645411|143216612|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.56|||||TWO_SIDED|95.0|0.46|0.68|||ANOVA|||Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.||0.68|0.46|
71851202|NCT00645411|143216612|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.92|||||TWO_SIDED|95.0|0.79|1.08|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||1.08|0.79|
71851203|NCT00645411|143216612|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was \>0.667.|Ratio of GMTs|0.65|||||TWO_SIDED|95.0|0.54|0.78|||ANOVA|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0.78|0.54|
71851204|NCT00645411|143216612|NON_INFERIORITY_OR_EQUIVALENCE|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was \>0.667.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.71|1.06|||ANOVA|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||1.06|0.71|
71851205|NCT00645411|143216613|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference in % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-4.0|1.0|||binomial or the method of Miettinen and|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.||1|-4|
71851206|NCT00645411|143216613|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV - eTIV)|-9.0|||||TWO_SIDED|95.0|-13.0|-4.0|||binomial or Miettinen & Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.||-4|-13|
71851207|NCT00645411|143216613|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-15.0|||||TWO_SIDED|95.0|-21.0|-9.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.||-9|-21|
71851208|NCT00645411|143216613|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%|Difference % (cTIV minus eTIV)|-1.0|||||TWO_SIDED|95.0|-3.0|2.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.||2|-3|
71851209|NCT00645411|143216613|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|-5.0|||||TWO_SIDED|95.0|-9.5|0.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.||0|-9.5|
71851210|NCT00645411|143216613|NON_INFERIORITY_OR_EQUIVALENCE|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was \>-10%.|Difference % (cTIV minus eTIV)|0.0|||||TWO_SIDED|95.0|-6.0|6.0|||binominal or Miettinen &Nurimen method|||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.||6|-6|
71851211|NCT05062343|143216628|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71851212|NCT05062343|143216629|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71851213|NCT05062343|143216630|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71851214|NCT05062343|143216631|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71851215|NCT05062343|143216632|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
71851216|NCT05062343|143216633|SUPERIORITY|||||||0.045|||||||Chi-squared|||||||0.045
71851217|NCT05062343|143216634|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71902066|NCT00418834|143325809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-7.4|-1.8|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.8|-7.4|<0.001
71902067|NCT00418834|143325810|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.32|||<|0.001||95.0|4.52|8.84|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||8.84|4.52|<0.001
71902068|NCT00418834|143325811|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.87|||<|0.001||95.0|1.4|2.5|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.50|1.40|<0.001
71902069|NCT00418834|143325812|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.48|||<|0.001||95.0|3.98|7.55|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg|||7.55|3.98|<0.001
71679754|NCT02783729|142877142|SUPERIORITY||LSM Difference|-5.81|STANDARD_ERROR_OF_MEAN|4.481|=|0.1949|TWO_SIDED|95.0|-14.61|2.98||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 10 mg||2.98|-14.61|= 0.1949
71851218|NCT05062343|143216635|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71851219|NCT02138838|143216639|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|8.1||||0.48|TWO_SIDED|95.0|-13.7|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||29.9|-13.7|0.48
71851220|NCT02138838|143216640|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-9.9||||0.42|TWO_SIDED|95.0|-33.3|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by baseline age group (6-\<12 years, 12-\<18 years)|SOC+Cinacalcet - SOC|A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm's method at 0.05 (2-sided) should the primary endpoint achieve a significant result.||13.4|-33.3|0.42
71851221|NCT02138838|143216641|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-10.4||||0.25|TWO_SIDED|95.0|-27.7|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC|||6.8|-27.7|0.25
71851222|NCT02138838|143216642|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|19.0||||0.23|TWO_SIDED|95.0|-12.5|50.5|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||50.5|-12.5|0.23
71851223|NCT02138838|143216643|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.34||||0.059|TWO_SIDED|95.0|-0.7|0.01|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.||||0.01|-0.70|0.059
71851224|NCT02138838|143216644|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.76||||0.039|TWO_SIDED|95.0|0.04|1.48|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC|||1.48|0.04|0.039
71851225|NCT00780741|143216645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.09|TWO_SIDED|95.0|-0.01|0.21|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||0.21|-0.01|0.09
71851226|NCT00780741|143216646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-139.0||||0.24|TWO_SIDED|95.0|-377.0|94.0|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||94|-377|0.24
71851227|NCT00780741|143216647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-4.0|-1.8|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.|||-1.8|-4.0|<0.0001
71902070|NCT00418834|143325813|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||<|0.001||95.0|1.32|2.31|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg|||2.31|1.32|<0.001
71902071|NCT00418834|143325814|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|0.3|3.5|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||3.5|0.3|<0.001
71902072|NCT00418834|143325815|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.5|4.8|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.8|1.5|<0.001
71819640|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.121||0.6527|TWO_SIDED|95.0|-0.29|0.19|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.19|-0.29|0.6527
71819641|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.118||0.1647|TWO_SIDED|95.0|-0.4|0.07|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.40|0.1647
71819642|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.7093|TWO_SIDED|95.0|-0.18|0.26|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.26|-0.18|0.7093
71819643|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.107||0.6333|TWO_SIDED|95.0|-0.26|0.16|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.26|0.6333
71819644|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.5238|TWO_SIDED|95.0|-0.31|0.16|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.31|0.5238
71819645|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.117||0.0782|TWO_SIDED|95.0|-0.44|0.02|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.02|-0.44|0.0782
71819646|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.138||0.2346|TWO_SIDED|95.0|-0.44|0.11|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.44|0.2346
71819647|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.134||0.0631|TWO_SIDED|95.0|-0.52|0.01|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.01|-0.52|0.0631
71819648|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.131||0.6274|TWO_SIDED|95.0|-0.32|0.2|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|-0.32|0.6274
71851228|NCT01867307|143216674|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-220.0|STANDARD_ERROR_OF_MEAN|55.5|<|0.0001|TWO_SIDED|95.0|-440.6|-202.7||P-value is from a paired t-test.|Paired t- test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-202.7|-440.6|<0.0001
71851229|NCT01867307|143216674|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-234.0|STANDARD_ERROR_OF_MEAN|25.8|<|0.0001|TWO_SIDED|95.0|-312.3|-201.5||P-value is from a paired t-test|Paired t-test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.||-201.5|-312.3|<0.0001
71851230|NCT00623714|143216686|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.34||||0.011|TWO_SIDED|90.0|0.16|0.7||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.70|0.16|0.011
71851231|NCT00623714|143216687|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.4||||0.002|TWO_SIDED|95.0|0.26|0.63||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.63|0.26|0.002
71851232|NCT00267774|143216703|OTHER||||||<|0.0001||||||A 2-sided value of P\<0.05 was considered to indicate statistical significance.|t-test, 2 sided|||||||<0.0001
71851233|NCT03444298|143216704|SUPERIORITY|||||||0.67||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.67
71851234|NCT03444298|143216705|SUPERIORITY|||||||0.43||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.43
71851235|NCT03444298|143216706|SUPERIORITY|||||||0.27||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.27
71851236|NCT03444298|143216707|SUPERIORITY|||||||0.92||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.92
71819649|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.128||0.3589|TWO_SIDED|95.0|-0.37|0.14|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.37|0.3589
71819650|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7604|TWO_SIDED|95.0|-0.43|0.31|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.31|-0.43|0.7604
71819651|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.185||0.1106|TWO_SIDED|95.0|-0.66|0.07|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.07|-0.66|0.1106
71819652|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.222||0.9776|TWO_SIDED|95.0|-0.43|0.45|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-0.43|0.9776
71819653|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.217||0.3239|TWO_SIDED|95.0|-0.65|0.22|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.22|-0.65|0.3239
71819654|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.238||0.6736|TWO_SIDED|95.0|-0.57|0.37|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.37|-0.57|0.6736
71819655|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6136|TWO_SIDED|95.0|-0.58|0.34|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.34|-0.58|0.6136
71851237|NCT03444298|143216708|SUPERIORITY|||||||0.99||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.99
71851238|NCT03444298|143216708|SUPERIORITY|||||||0.04||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.04
71851239|NCT03444298|143216709|SUPERIORITY|||||||0.98||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.98
71851240|NCT03444298|143216709|SUPERIORITY|||||||0.02||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.02
71851241|NCT03444298|143216710|SUPERIORITY|||||||0.84||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.84
71851242|NCT03444298|143216711|SUPERIORITY|||||||0.59||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.59
71851243|NCT03444298|143216712|SUPERIORITY|||||||0.83||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.83
71851244|NCT03444298|143216713|SUPERIORITY|||||||0.51||||||The a priori threshold for statistical significance is \<0.05.|Mixed Models Analysis|||||||0.51
71851245|NCT03444298|143216714|SUPERIORITY|||||||0.48||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||0.48
71851246|NCT03444298|143216715|SUPERIORITY||||||<|0.01||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.01
71851247|NCT03444298|143216716|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance is \<0.05.|t-test, 2 sided|||||||<0.0001
71851248|NCT01857362|143216742|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|Ratio of geomectric means|1.0|||||TWO_SIDED|90.0|0.988|1.045|||ANOVA|||||1.045|0.988|
71851249|NCT01857362|143216743|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|ratio of geometric means|0.989|||||TWO_SIDED|90.0|0.945|1.034|||ANOVA|||||1.034|0.945|
71851250|NCT00507429|143216773|SUPERIORITY_OR_OTHER|||||||0.223|||||||Log Rank|||||||0.223
71851251|NCT00674609|143216793|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.67||||0.014|TWO_SIDED|95.0|-1.21|-0.14|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||-0.14|-1.21|0.014
71851252|NCT00674609|143216793|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.32||||0.244|TWO_SIDED|95.0|-0.86|0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.||0.22|-0.86|0.244
71851253|NCT00674609|143216794|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.31||||0.346|TWO_SIDED|95.0|-0.97|0.34|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.34|-0.97|0.346
71851254|NCT00674609|143216794|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.02||||0.95|TWO_SIDED|95.0|-0.64|0.68|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||0.68|-0.64|0.95
71851255|NCT00674609|143216795|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.49||||0.11|TWO_SIDED|95.0|-0.11|1.09|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.09|-0.11|0.11
71851256|NCT00674609|143216795|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.46||||0.126|TWO_SIDED|95.0|-0.13|1.05|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.05|-0.13|0.126
71851257|NCT00674609|143216796|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.65||||0.045|TWO_SIDED|95.0|0.01|1.28|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.28|0.01|0.045
71851258|NCT00674609|143216796|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.62||||0.053|TWO_SIDED|95.0|-0.01|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|-0.01|0.053
71851259|NCT00674609|143216797|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.83||||0.016|TWO_SIDED|95.0|0.16|1.51|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.51|0.16|0.016
71851260|NCT00674609|143216797|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.66||||0.056|TWO_SIDED|95.0|-0.02|1.33|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.33|-0.02|0.056
71851261|NCT00674609|143216798|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.68||||0.021|TWO_SIDED|95.0|0.1|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.25|0.10|0.021
71851262|NCT00674609|143216798|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|0.64||||0.028|TWO_SIDED|95.0|0.07|1.22|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of \< 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.||1.22|0.07|0.028
71851263|NCT00674609|143216799|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|2.47||||0.443|TWO_SIDED|95.0|-3.87|8.81|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||8.81|-3.87|0.443
71851264|NCT00674609|143216799|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|0.84||||0.793|TWO_SIDED|95.0|-5.46|7.13|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.||7.13|-5.46|0.793
71902073|NCT00418834|143325816|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-14.2|-10.3|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.3|-14.2|<0.001
71902074|NCT00418834|143325817|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.3|<|0.001||95.0|-6.8|-1.7|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-1.7|-6.8|<0.001
71902075|NCT00418834|143325818|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0|-9.4|-6.5|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-6.5|-9.4|<0.001
71819656|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.195||0.1141|TWO_SIDED|95.0|-0.7|0.08|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.70|0.1141
71819657|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.194||0.2185|TWO_SIDED|95.0|-0.62|0.14|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.62|0.2185
71819658|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.054||0.6191|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6191
71819659|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.053||0.6169|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6169
71851265|NCT00674609|143216800|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.04||||0.619|TWO_SIDED|95.0|-5.23|3.15|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||3.15|-5.23|0.619
71851266|NCT00674609|143216800|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-4.07||||0.048|TWO_SIDED|95.0|-8.1|-0.05|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.||-0.05|-8.10|0.048
71851267|NCT00674609|143216801|SUPERIORITY_OR_OTHER_LEGACY||estimated mean treatment difference|-0.04||||0.688|TWO_SIDED|95.0|-0.25|0.16|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.16|-0.25|0.688
71851268|NCT00674609|143216801|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.01||||0.899|TWO_SIDED|95.0|-0.19|0.22|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.||0.22|-0.19|0.899
71851269|NCT03785756|143216802|EQUIVALENCE|The primary analysis was based on a two-sided test at the significance level of 0.05. The treatment difference is presented with a 95% confidence interval (CI).|Mean Difference (Final Values)|34.05|||<|0.0001|TWO_SIDED|95.0|26.72|41.38|||ANCOVA|Estimates from an ANCOVA model with SPID12 score as the dependent variable. Terms for treatment and baseline pain score were included as covariates.||The primary efficacy hypothesis was that SPID12 for placebo was equal to SPID12 for ibuprofen 2 × 300 mg PR tablets.||41.38|26.72|<0.0001
71851270|NCT03884478|143216839|OTHER||Mean Difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.82||0.0001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.0001
71851271|NCT03884478|143216839|OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.77||0.005|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Control Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.005
71851272|NCT03884478|143216839|OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.82||0.25|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol Only Arm.||||.25
71851273|NCT03884478|143216840|OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.84||0.025|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.025
71851274|NCT03884478|143216840|OTHER||Mean Difference (Final Values)|1.24|STANDARD_ERROR_OF_MEAN|0.79||0.11|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.11
71851275|NCT03884478|143216840|OTHER||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.84||0.66|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.66
71851276|NCT03884478|143216841|OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
71851277|NCT03884478|143216841|OTHER||Mean Difference (Final Values)|1.48|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
71851278|NCT03884478|143216841|OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.25||0.88|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.88
71851279|NCT03884478|143216842|OTHER||Mean Difference (Final Values)|0.55|STANDARD_ERROR_OF_MEAN|0.26||0.03|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||.03
71851280|NCT03884478|143216842|OTHER||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.24||0.059|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.059
71851281|NCT03884478|143216842|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.26||0.71|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.71
71902076|NCT00418834|143325819|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-3.8|-0.2|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.2|-3.8|<0.001
71902077|NCT00418834|143325820|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.2|||<|0.001||95.0|-9.0|-3.4|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||-3.4|-9.0|<0.001
71851282|NCT03884478|143216843|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
71902078|NCT00418834|143325821|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.1|||<|0.001||95.0|-5.2|1.0|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates~of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"|||1.0|-5.2|<0.001
71819660|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9911|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9911
71851283|NCT03884478|143216843|OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||<.001
71851284|NCT03884478|143216843|OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.19||0.87|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.87
71851285|NCT03884478|143216844|OTHER||Median Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.||||<.001
71851286|NCT03884478|143216844|OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.19||0.002|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.||||.002
71851287|NCT03884478|143216844|OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.2||0.43|TWO_SIDED||||||Mixed Models Analysis|||As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.||||.43
71851288|NCT02301299|143216900|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the early hospital arrival would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG.||The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly early arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
71902079|NCT00418834|143325822|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.1|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-11.0|-7.3|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-11.0|<0.001
71902080|NCT00418834|143325823|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-5.5|-0.9|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-0.9|-5.5|<0.001
71902081|NCT00418834|143325824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.8||0.401||95.0|-0.9|2.1|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||2.1|-0.9|0.401
71819661|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.336|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3360
71819662|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.054||0.9638|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9638
71902082|NCT00418834|143325825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.8|<|0.001||95.0|1.1|4.2|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||4.2|1.1|<0.001
71819663|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.053||0.161|TWO_SIDED|95.0|-0.03|0.18|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.18|-0.03|0.1610
71819664|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.054||0.5763|TWO_SIDED|95.0|-0.14|0.08|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.14|0.5763
71902083|NCT00418834|143325826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-10.7|-7.3|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.3|-10.7|<0.001
71902084|NCT00418834|143325827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.001||95.0|-6.8|-2.4|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.4|-6.8|<0.001
71902085|NCT00418834|143325828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-17.0|-12.2|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-12.2|-17.0|<0.001
71902086|NCT00418834|143325829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-10.1|-3.7|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.7|-10.1|<0.001
71902087|NCT00418834|143325830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.001||95.0|-11.6|-7.5|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-7.5|-11.6|<0.001
71902088|NCT00418834|143325831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.7|-2.9|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-2.9|-7.7|<0.001
71902089|NCT00418834|143325832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.9|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-15.3|-10.5|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)|||-10.5|-15.3|<0.001
71819665|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.053||0.0599|TWO_SIDED|95.0|0.0|0.2|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.20|0.00|0.0599
71902090|NCT00418834|143325833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.8|-3.6|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)|||-3.6|-9.8|<0.001
71902091|NCT00418834|143325834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.8||||0.534||95.0|-11.9|6.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||6.4|-11.9|0.534
71902092|NCT00418834|143325835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0||||0.09||95.0|-15.6|1.6|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."|||1.6|-15.6|0.090
71902093|NCT01520324|143325848|OTHER|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.||||||||||||||||The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with intraepithelial neoplasiae was presented|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.|||
71902094|NCT02163993|143325867|SUPERIORITY||Posterior Mean Difference|-0.57|STANDARD_DEVIATION|0.42|||TWO_SIDED|95.0|-1.4|0.24|||Bayesian Dose Response Model|||||0.24|-1.40|
71902095|NCT02163993|143325867|SUPERIORITY||Posterior Mean Difference|-0.25|STANDARD_DEVIATION|0.41|||TWO_SIDED|95.0|-1.06|0.56|||Bayesian Dose Response Model|||||0.56|-1.06|
71902096|NCT02163993|143325867|SUPERIORITY||Posterior Mean Difference|-1.14|STANDARD_DEVIATION|0.44|||TWO_SIDED|95.0|-2.02|-0.29|||Bayesian Dose Response Model|||||-0.29|-2.02|
71902097|NCT02163993|143325867|SUPERIORITY||Posterior Mean Difference|-0.62|STANDARD_DEVIATION|0.45|||TWO_SIDED|95.0|-1.5|0.27|||Bayesian Dose Response Model|||||0.27|-1.50|
71902098|NCT01345123|143325894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0019994|STANDARD_ERROR_OF_MEAN|0.0400918||0.9602|TWO_SIDED|95.0|-0.0765899|0.080588716|||ANCOVA|Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm||||.080588716|-.07658990|0.9602
71902099|NCT01345123|143325894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013717|STANDARD_ERROR_OF_MEAN|0.04018791||0.7329|TWO_SIDED|95.0|-0.0924947|0.06506063|||ANCOVA|||||0.06506063|-0.0924947|0.7329
71902100|NCT01345123|143325895|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.805||||0.0511||95.0|0.647|1.001|||Regression, Logistic|Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)||||1.001|0.647|0.0511
71902101|NCT01345123|143325898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31257||||0.0106|TWO_SIDED|95.0|0.06895|0.55618|||ANOVA|||||0.55618|0.06895|0.0106
71819666|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3916|TWO_SIDED|95.0|-0.15|0.06|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.15|0.3916
71819667|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9602|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.10|0.9602
71851289|NCT02301299|143216901|OTHER|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the EMS use would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|||The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.|||<.0001
71851290|NCT01345253|143216948|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99||||0.0001|TWO_SIDED|95.0|1.4|2.82|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).|||2.82|1.40|0.0001
71851291|NCT01345253|143216949|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.0||||0.0001|TWO_SIDED|95.0|1.41|2.83|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.83|1.41|0.0001
71851292|NCT01345253|143216950|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.76||||0.0116|TWO_SIDED|95.0|1.13|2.74|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|||2.74|1.13|0.0116
71851293|NCT01345253|143216951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0288|||||||Rank ANCOVA|||||||0.0288
71851294|NCT01345253|143216952|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0004|TWO_SIDED|95.0|0.34|0.73|||Regression, Cox|||||0.73|0.34|0.0004
71902102|NCT01345123|143325898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15982||||0.0106|TWO_SIDED|95.0|-0.06477|0.38441|||ANOVA|||||0.38441|-0.06477|0.0106
71902103|NCT01345123|143325901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009122|STANDARD_ERROR_OF_MEAN|0.0467091||0.8454|TWO_SIDED|95.0|-0.1008434|0.08259938|||ANCOVA|||||0.08259938|-0.1008434|0.8454
71851295|NCT01767376|143216967|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.19|||||TWO_SIDED|95.0|0.97|1.48|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination.||1.48|0.97|
71902104|NCT01345123|143325901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.0183548|STANDARD_ERROR_OF_MEAN|0.04690321||0.6956|TWO_SIDED|95.0|-0.1102961|0.07358642|||ANCOVA|||||0.07358642|-0.1102961|0.6956
71902105|NCT02658994|143325902|SUPERIORITY||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.33|0.07||||||||0.07|-0.33|
71902106|NCT02658994|143325903|SUPERIORITY||Median Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-1.39|1.19||||||||1.19|-1.39|
71902107|NCT02658994|143325904|SUPERIORITY||Mean Difference (Final Values)|-0.12|||||TWO_SIDED|95.0|-0.33|0.09||||||||0.09|-0.33|
71902108|NCT02658994|143325905|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.19|0.96||||||Child Bayley scaled receptive score||0.96|-0.19|
71902109|NCT02658994|143325905|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|95.0|-0.83|0.9||||||Child Bayley scaled fine motor score||0.90|-0.83|
71902110|NCT02658994|143325906|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.43|1.05||||||||1.05|0.43|
71902111|NCT02658994|143325907|SUPERIORITY||Risk Ratio (RR)|-0.09|||||TWO_SIDED|95.0|-0.32|0.15||||||Length-for-age z-scores||0.15|-0.32|
71902112|NCT02658994|143325907|SUPERIORITY||Risk Ratio (RR)|-0.12|||||TWO_SIDED|95.0|-0.33|0.1||||||Weight-for-age z-scores||0.10|-0.33|
71819668|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.055||0.9676|TWO_SIDED|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.11|-0.11|0.9676
71851296|NCT01767376|143216967|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.12|||||TWO_SIDED|95.0|0.85|1.47|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, one month after Nimenrix vaccination.||1.47|0.85|
71819669|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6397|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6397
71819670|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.34|TWO_SIDED|95.0|-0.05|0.16|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.05|0.3400
71819671|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.053||0.3472|TWO_SIDED|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.15|-0.05|0.3472
71819672|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.916|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9160
71819673|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.053||0.5948|TWO_SIDED|95.0|-0.13|0.08|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.13|0.5948
71819674|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.054||0.3755|TWO_SIDED|95.0|-0.06|0.16|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.16|-0.06|0.3755
71819675|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.053||0.9752|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9752
71819676|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.054||0.9188|TWO_SIDED|95.0|-0.11|0.1|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.10|-0.11|0.9188
71851297|NCT01767376|143216967|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.86|1.32|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, one month after Nimenrix vaccination.||1.32|0.86|
71851298|NCT01767376|143216967|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.27|||||TWO_SIDED|95.0|1.02|1.59|||ANCOVA|||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, one month after Nimenrix vaccination.||1.59|1.02|
71819677|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.053||0.6379|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.08|0.6379
71819678|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.061||0.4967|TWO_SIDED|95.0|-0.16|0.08|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.08|-0.16|0.4967
71819679|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.3492|TWO_SIDED|95.0|-0.17|0.06|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.06|-0.17|0.3492
71819680|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.062||0.7136|TWO_SIDED|95.0|-0.1|0.14|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.14|-0.10|0.7136
71819681|NCT02942004|143141929|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.059||0.8163|TWO_SIDED|95.0|-0.1|0.13|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-0.10|0.8163
71819682|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.055||0.2825|TWO_SIDED|95.0|-0.17|0.05|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.05|-0.17|0.2825
71819683|NCT02942004|143141929|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.054||0.1603|TWO_SIDED|95.0|-0.18|0.03|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.03|-0.18|0.1603
71819684|NCT02942004|143141930|SUPERIORITY||LS mean difference|-6.85|STANDARD_ERROR_OF_MEAN|2.414||0.0054|TWO_SIDED|95.0|-11.64|-2.07|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-2.07|-11.64|0.0054
71819685|NCT02942004|143141930|SUPERIORITY||LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|2.35||0.0763|TWO_SIDED|95.0|-8.86|0.45|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.45|-8.86|0.0763
71819686|NCT02942004|143141930|SUPERIORITY||LS mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.673||0.1101|TWO_SIDED|95.0|-9.6|0.99|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.99|-9.60|0.1101
71851299|NCT01767376|143216968|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-2.14|||||TWO_SIDED|95.0|-7.88|3.53||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.||3.53|-7.88|
71902113|NCT01763905|143325936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.06|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-43.73|-32.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.99|-43.73|<0.001
71819687|NCT02942004|143141930|SUPERIORITY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|2.618||0.6167|TWO_SIDED|95.0|-6.5|3.87|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.87|-6.50|0.6167
71819688|NCT02942004|143141930|SUPERIORITY||LS mean difference|-5.64|STANDARD_ERROR_OF_MEAN|2.777||0.0447|TWO_SIDED|95.0|-11.14|-0.14|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||-0.14|-11.14|0.0447
71819689|NCT02942004|143141930|SUPERIORITY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|2.726||0.1908|TWO_SIDED|95.0|-8.99|1.81|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.81|-8.99|0.1908
71819690|NCT02942004|143141931|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0131|TWO_SIDED|95.0|1.3|11.7|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.7|1.3|0.0131
71819691|NCT02942004|143141931|SUPERIORITY||Odds Ratio (OR)|4.0||||0.0095|TWO_SIDED|95.0|1.4|11.6|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||11.6|1.4|0.0095
71819692|NCT02942004|143141931|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0323|TWO_SIDED|95.0|1.1|7.5|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||7.5|1.1|0.0323
71819693|NCT02942004|143141931|SUPERIORITY||Odds Ratio (OR)|2.2||||0.0931|TWO_SIDED|95.0|0.9|5.3|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||5.3|0.9|0.0931
71819694|NCT02942004|143141931|SUPERIORITY||Odds Ratio (OR)|3.6||||0.0139|TWO_SIDED|95.0|1.3|10.0|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||10.0|1.3|0.0139
71819695|NCT02942004|143141931|SUPERIORITY||Odds Ratio (OR)|2.6||||0.046|TWO_SIDED|95.0|1.0|6.9|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.||6.9|1.0|0.0460
71819696|NCT02942004|143141932|SUPERIORITY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|1.454||0.4389|TWO_SIDED|95.0|-4.01|1.75|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.75|-4.01|0.4389
71819697|NCT02942004|143141932|SUPERIORITY||LS mean difference|-1.05|STANDARD_ERROR_OF_MEAN|1.427||0.4645|TWO_SIDED|95.0|-3.88|1.78|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.78|-3.88|0.4645
71902114|NCT01763905|143325936|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-42.16|-32.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-32.94|-42.16|<0.001
71819698|NCT02942004|143141932|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.356||0.0622|TWO_SIDED|95.0|-5.24|0.13|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.13|-5.24|0.0622
71679755|NCT02783729|142877142|SUPERIORITY||LSM Difference|14.45|STANDARD_ERROR_OF_MEAN|5.241|=|0.0059|TWO_SIDED|95.0|4.16|24.73||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||24.73|4.16|= 0.0059
71679756|NCT02783729|142877142|SUPERIORITY||LSM Difference|5.36|STANDARD_ERROR_OF_MEAN|5.241|=|0.3064|TWO_SIDED|95.0|-4.92|15.65||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||15.65|-4.92|= 0.3064
71679757|NCT02783729|142877142|SUPERIORITY||LSM Difference|-6.57|STANDARD_ERROR_OF_MEAN|5.325|=|0.2174|TWO_SIDED|95.0|-17.02|3.88||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 5 mg||3.88|-17.02|= 0.2174
71679758|NCT02783729|142877142|SUPERIORITY||LSM Difference|8.88|STANDARD_ERROR_OF_MEAN|5.313|=|0.0949|TWO_SIDED|95.0|-1.55|19.31||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 10 mg||19.31|-1.55|= 0.0949
71679759|NCT02783729|142877142|SUPERIORITY||LSM Difference|-6.82|STANDARD_ERROR_OF_MEAN|6.207|=|0.2718|TWO_SIDED|95.0|-19.01|5.36||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||5.36|-19.01|= 0.2718
71679760|NCT02783729|142877142|SUPERIORITY||LSM Difference|7.43|STANDARD_ERROR_OF_MEAN|6.206|=|0.2317|TWO_SIDED|95.0|-4.75|19.61||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||19.61|-4.75|= 0.2317
71679761|NCT02783729|142877143|SUPERIORITY||LSM Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.063|=|0.1963|TWO_SIDED|95.0|-3.46|0.71||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 5 mg||0.71|-3.46|= 0.1963
71679762|NCT02783729|142877143|SUPERIORITY|Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate|LSM Difference|1.7|STANDARD_ERROR_OF_MEAN|1.06|=|0.1093|TWO_SIDED|95.0|-0.38|3.78|||MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 10 mg||3.78|-0.38|= 0.1093
71902115|NCT01763905|143325937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.3|STANDARD_ERROR_OF_MEAN|5.9|<|0.001|TWO_SIDED|95.0|-77.9|-54.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-54.7|-77.9|<0.001
71679763|NCT02783729|142877143|SUPERIORITY||LSM Difference|-1.53|STANDARD_ERROR_OF_MEAN|1.247|=|0.2196|TWO_SIDED|95.0|-3.98|0.92||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||0.92|-3.98|= 0.2196
71679764|NCT02783729|142877143|SUPERIORITY||LSM Difference|1.05|STANDARD_ERROR_OF_MEAN|1.246|=|0.4013|TWO_SIDED|95.0|-1.4|3.49||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||3.49|-1.4|= 0.4013
71679765|NCT02783729|142877144|SUPERIORITY||LSGM Ratio|0.85|||=|0.0092|TWO_SIDED|95.0|0.752|0.961||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 5 mg||0.961|0.752|= 0.0092
71679766|NCT02783729|142877144|SUPERIORITY||LSGM Ratio|0.795|||=|0.0002|TWO_SIDED|95.0|0.704|0.899||Based on MMRM model with factors of age group, region, treatment, visit (Days1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 10 mg||0.899|0.704|= 0.0002
71679767|NCT02783729|142877144|SUPERIORITY||LSM Difference|-33.4|STANDARD_ERROR_OF_MEAN|2.711|<|0.0001|TWO_SIDED|95.0|-38.71|-28.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 5 mg||-28.09|-38.71|< 0.0001
71679768|NCT02783729|142877144|SUPERIORITY||LSM Difference|-42.27|STANDARD_ERROR_OF_MEAN|2.705|<|0.0001|TWO_SIDED|95.0|-47.57|-36.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 10 mg||-36.97|-47.57|< 0.0001
71679769|NCT02783729|142877144|SUPERIORITY||LSM Difference|-21.66|STANDARD_ERROR_OF_MEAN|2.221|<|0.0001|TWO_SIDED|95.0|-26.01|-17.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-17.3|-26.01|< 0.0001
71679770|NCT02783729|142877144|SUPERIORITY||LSM Difference|-28.33|STANDARD_ERROR_OF_MEAN|2.219|<|0.0001|TWO_SIDED|95.0|-32.68|-23.98||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-23.98|-32.68|< 0.0001
71679771|NCT02783729|142877144|SUPERIORITY||LSM Difference|44.05|STANDARD_ERROR_OF_MEAN|3.291|<|0.0001|TWO_SIDED|95.0|37.59|50.51||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||50.51|37.59|< 0.0001
71679772|NCT02783729|142877144|SUPERIORITY||LSM Difference|56.9|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|50.46|63.34||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||63.34|50.46|< 0.0001
71679773|NCT02783729|142877145|SUPERIORITY||LSM Difference|9.01|STANDARD_ERROR_OF_MEAN|0.666|<|0.0001|TWO_SIDED|95.0|7.7|10.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 5 mg||10.31|7.7|< 0.0001
71679774|NCT02783729|142877145|SUPERIORITY||LSM Difference|11.6|STANDARD_ERROR_OF_MEAN|0.664|<|0.0001|TWO_SIDED|95.0|10.3|12.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 10 mg||12.9|10.3|< 0.0001
71819699|NCT02942004|143141932|SUPERIORITY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|1.338||0.8495|TWO_SIDED|95.0|-2.4|2.91|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.91|-2.40|0.8495
71819700|NCT02942004|143141932|SUPERIORITY||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|1.59||0.7063|TWO_SIDED|95.0|-3.75|2.55|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.55|-3.75|0.7063
71819701|NCT02942004|143141932|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|1.552||0.9434|TWO_SIDED|95.0|-3.19|2.97|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.97|-3.19|0.9434
71851300|NCT01767376|143216968|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-0.44|||||TWO_SIDED|95.0|-2.48|1.26||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.||1.26|-2.48|
71851301|NCT01767376|143216969|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.66|0.89|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.||0.89|0.66|
71851302|NCT01767376|143216969|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.||0.65|0.50|
71851303|NCT01767376|143216969|NON_INFERIORITY|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.72|||||TWO_SIDED|95.0|0.59|0.88|||ANCOVA|||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.||0.88|0.59|
71851304|NCT04883541|143216993|SUPERIORITY|the t-test in independent groups|Mean Difference (Net)|0.02|STANDARD_DEVIATION|0.8|<|0.05|TWO_SIDED|0.05|||||t-test, 2 sided|||||||<0.05
71851305|NCT00841321|143217012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1|TWO_SIDED|95.0|-0.5|0.1||Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||PASAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.1|-0.5|.1
71851306|NCT00841321|143217012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.9|-0.1||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||Stroop Exit Z-score least square means difference adjusted for baseline.Positive values indicate a beneficial effect from treatment with Ginkgo.||-0.1|-0.9|0.007
71851307|NCT00841321|143217012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.5|TWO_SIDED|95.0|-0.2|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||COWAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.2|0.5
71851308|NCT00841321|143217012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.5||95.0|-0.3|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||CVLT-II Delayed Recall Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.||0.3|-0.3|0.5
71851309|NCT00841321|143217012|SUPERIORITY_OR_OTHER|||||||0.19|||||||MANCOVA|MANCOVA||MANCOVA for all four cognitive tests at exit adjusting for baseline. Individual ANOVAs were to follow if the multivariate test was significant.||||0.19
71851310|NCT00841321|143217013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.7||0.4|TWO_SIDED|95.0|-5.7|4.7|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Perceived Deficits Questionnaire||4.7|-5.7|0.4
71851311|NCT00841321|143217013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.0||0.7||95.0|-3.2|4.8|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Multiple Sclerosis Neuropsychological Questionnaire||4.8|-3.2|0.7
71851312|NCT00841321|143217013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.6||0.4||95.0|-1.3|0.8|||ANCOVA|||Community Integration Questionnaire||0.8|-1.3|0.4
71851313|NCT01358175|143217014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.2|6.42|||Regression, Logistic|||||6.42|2.20|<0.0001
71851314|NCT01358175|143217014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.89|||<|0.0001|TWO_SIDED|95.0|2.28|6.65|||Regression, Logistic|||||6.65|2.28|<0.0001
71851315|NCT02379078|143217022|SUPERIORITY|||||||0.0246|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.0246
71851316|NCT02379078|143217023|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71851317|NCT02379078|143217024|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
71851318|NCT02379078|143217025|SUPERIORITY|||||||0.468|||||||Mixed Models Analysis|||||||0.468
71851319|NCT02379078|143217026|SUPERIORITY|||||||0.6|||||||ANOVA|||||||0.60
71851320|NCT04908488|143217027|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least Squares Means Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||-0.01|||Mixed effects repeated measures model|Within subject correlation due to eye and the crossover design were accounted for in the model.|Lens difference (P1fA minus AMfA)|||-0.01||
71851321|NCT03014726|143217039|OTHER|Recurrence \< 0.5 as defined by an IPSS score of less than or equal to 11. The performance goal is met if the upper limit of the one-sided 95% confidence interval for recurrence is less than 50%.|||||<|0.001|||||||1-sample binomial z-test|||||||<0.001
71851322|NCT00901459|143217040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47|STANDARD_ERROR_OF_MEAN|0.44||0.014|TWO_SIDED|95.0|0.51|2.43||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=14|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (Frequency control)and the corresponding craving change in the 1Hz sfg condition (active).|A pairwise t-test was performed to contrast the active rTMS condition with the frequency control condition.||2.43|0.51|0.014
71851323|NCT00901459|143217040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.4||0.49|TWO_SIDED|95.0|-0.64|1.22|||t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 1Hz sfg condition (active)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the active rTMS condition with the location control condition.||1.22|-0.64|0.49
71851324|NCT00901459|143217040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.95|STANDARD_ERROR_OF_MEAN|0.44||0.09|TWO_SIDED|95.0|0.52|1.39||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (frequency control)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the location control rTMS condition with the frequency control condition.||1.39|0.52|0.09
71851325|NCT00848198|143217047|SUPERIORITY_OR_OTHER||Sensitivity|87.1|||||TWO_SIDED|95.0|83.2|90.9||||||||90.9|83.2|
71851326|NCT00848198|143217047|SUPERIORITY_OR_OTHER||Specificity|72.0|||||TWO_SIDED|95.0|66.9|77.1||||||||77.1|66.9|
71851327|NCT00848198|143217048|SUPERIORITY_OR_OTHER||Sensitivity|39.7|||||TWO_SIDED|95.0|34.2|45.3||||||||45.3|34.2|
71851328|NCT00848198|143217048|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
71851329|NCT00848198|143217049|SUPERIORITY_OR_OTHER||Sensitivity|71.9|||||TWO_SIDED|95.0|66.8|77.0||||||||77.0|66.8|
71851330|NCT00848198|143217049|SUPERIORITY_OR_OTHER||Specificity|82.7|||||TWO_SIDED|95.0|78.4|87.0||||||||87.0|78.4|
71851331|NCT00848198|143217050|SUPERIORITY_OR_OTHER||Sensitivity|27.2|||||TWO_SIDED|95.0|22.2|32.3||||||||32.3|22.2|
71851332|NCT00848198|143217050|SUPERIORITY_OR_OTHER||Specificity|98.7|||||TWO_SIDED|95.0|97.4|100.0||||||||100.0|97.4|
71851333|NCT00848198|143217051|SUPERIORITY_OR_OTHER||Sensitivity|51.3|||||TWO_SIDED|95.0|45.7|57.0||||||||57.0|45.7|
71851334|NCT00848198|143217051|SUPERIORITY_OR_OTHER||Specificity|94.7|||||TWO_SIDED|95.0|92.1|97.2||||||||97.2|92.1|
71851335|NCT00848198|143217052|SUPERIORITY_OR_OTHER||Sensitivity|61.2|||||TWO_SIDED|95.0|55.6|66.7||||||||66.7|55.6|
71851336|NCT00848198|143217052|SUPERIORITY_OR_OTHER||Specificity|78.7|||||TWO_SIDED|95.0|74.0|83.3||||||||83.3|74.0|
71851337|NCT00848198|143217053|SUPERIORITY_OR_OTHER||Sensitivity|58.5|||||TWO_SIDED|95.0|52.9|64.1||||||||64.1|52.9|
71851338|NCT00848198|143217053|SUPERIORITY_OR_OTHER||Specificity|73.3|||||TWO_SIDED|95.0|68.3|78.3||||||||78.3|68.3|
71851339|NCT04791917|143217091|SUPERIORITY|||||||0.26|||||||ANCOVA|F(1,41) = 1.32, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.26
71851340|NCT04791917|143217092|SUPERIORITY|||||||0.11|||||||ANCOVA|F(1,43) = 2.60, partial eta squared = .06||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for alcohol including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.11
71851341|NCT04791917|143217093|SUPERIORITY|||||||0.17|||||||ANCOVA|F(1,42) = 1.95, partial eta squared = .04||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol Pmax including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.17
71819702|NCT02942004|143141932|SUPERIORITY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|1.608||0.9701|TWO_SIDED|95.0|-3.25|3.13|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||3.13|-3.25|0.9701
71819703|NCT02942004|143141932|SUPERIORITY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|1.566||0.6307|TWO_SIDED|95.0|-3.86|2.35|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||2.35|-3.86|0.6307
71819704|NCT02942004|143141932|SUPERIORITY||LS mean difference|-2.02|STANDARD_ERROR_OF_MEAN|1.488||0.1767|TWO_SIDED|95.0|-4.97|0.93|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||0.93|-4.97|0.1767
71819705|NCT02942004|143141932|SUPERIORITY||LS mean difference|-1.46|STANDARD_ERROR_OF_MEAN|1.468||0.3236|TWO_SIDED|95.0|-4.37|1.45|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.||1.45|-4.37|0.3236
71819706|NCT01448044|143141948|SUPERIORITY_OR_OTHER||difference in percentages|38.85|||<|0.0001|TWO_SIDED|95.0|21.703|55.997||The pvalue was based on the CochranMantelHaenszel (CMH) test, stratified by IL28B host genotype, geography, and baseline cirrhosis status.|Cochran-Mantel-Haenszel|||||55.997|21.703|<0.0001
71679775|NCT02783729|142877146|SUPERIORITY||LSM Difference|-16.41|STANDARD_ERROR_OF_MEAN|2.457|<|0.0001|TWO_SIDED|95.0|-21.23|-11.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg||-11.6|-21.23|< 0.0001
71679776|NCT02783729|142877146|SUPERIORITY||LSM Difference|-17.76|STANDARD_ERROR_OF_MEAN|2.451|<|0.0001|TWO_SIDED|95.0|-22.57|-12.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg||-12.96|-22.57|< 0.0001
71819707|NCT00507026|143141957|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819708|NCT00507026|143141957|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71851342|NCT04791917|143217094|SUPERIORITY|||||||0.91|||||||ANCOVA|F(1,43)=.01, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on alcohol essential value including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.91
71851343|NCT04791917|143217095|SUPERIORITY|||||||0.14|||||||ANCOVA|F(1,41) = 2.24, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.14
71851344|NCT04791917|143217096|SUPERIORITY|||||||0.83|||||||ANCOVA|F(1,41) = .04, partial eta squared = .001||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on breakpoint of cannabis demand including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.83
71902116|NCT01763905|143325937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-80.5|-60.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-60.7|-80.5|<0.001
71819709|NCT00507026|143141958|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819710|NCT00507026|143141958|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819711|NCT00507026|143141959|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819712|NCT00507026|143141959|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819713|NCT00507026|143141960|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819714|NCT00507026|143141960|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819715|NCT00507026|143141961|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819716|NCT00507026|143141961|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71819717|NCT03688711|143141983|SUPERIORITY||||||<|0.0001|||||||Log Rank|||The recovery rates of dasiglucagon and placebo were evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests stratified by injection site.||||<0.0001
71819718|NCT03688711|143141984|SUPERIORITY|||||||0.0012|||||||Fisher Exact|||Assessed at 30 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0012
71819719|NCT03688711|143141984|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 20 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71679777|NCT02783729|142877146|SUPERIORITY||LSM Difference|34.16|STANDARD_ERROR_OF_MEAN|3.673|<|0.0001|TWO_SIDED|95.0|26.95|41.36||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg||41.36|26.95|< 0.0001
71679778|NCT02783729|142877146|SUPERIORITY||LSM Difference|38.85|STANDARD_ERROR_OF_MEAN|3.672|<|0.0001|TWO_SIDED|95.0|31.64|46.05||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg||46.05|31.64|< 0.0001
71679779|NCT02783729|142877147|SUPERIORITY||LSGM Ratio|0.815|||<|0.0001|TWO_SIDED|95.0|0.745|0.891||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||0.891|0.745|< 0.0001
71851345|NCT04791917|143217097|SUPERIORITY|||||||0.15|||||||ANCOVA|F(1,41) = 2.20, partial eta squared = .05||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.15
71851346|NCT04791917|143217098|SUPERIORITY|||||||0.24|||||||ANCOVA|F(1,41) = 1.41, partial eta squared = .03||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Omax for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.24
71851347|NCT04791917|143217099|SUPERIORITY|||||||0.97|||||||ANCOVA|F(1,41) = .001, partial eta squared = .00||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.97
71851348|NCT04791917|143217099|SUPERIORITY|||||||0.03|||||||ANCOVA|F(1,41) = 4.86, partial eta squared = .11||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Essential Value for cannabis including baseline urge to consume cannabis and CUDIT score as covariates. Here we report the results of the analysis of the Time X Group interaction.||||.03
71851349|NCT04791917|143217100|SUPERIORITY|||||||0.04|||||||ANCOVA|F(1,42) = 4.66, partial eta squared = .10||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the Sex X Time X Group interaction.||||.04
71851350|NCT04791917|143217100|SUPERIORITY||Slope|0.1||||0.26|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the DOMS group.||||.26
71902117|NCT01763905|143325938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.7|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-82.0|-57.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-57.5|-82.0|<0.001
71851351|NCT04791917|143217100|SUPERIORITY||Slope|-0.09||||0.22|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the DOMS group.||||.22
71851352|NCT04791917|143217100|SUPERIORITY||Slope|-0.1||||0.27|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for men in the sham DOMS group.||||.27
71851353|NCT04791917|143217100|SUPERIORITY||Slope|0.06||||0.49|TWO_SIDED||||||ANCOVA|||2 (Sex: men vs. women) X 2 (Time: Pre- vs. post-exercise) x 2 (Group: DOMS vs. sham DOMS) mixed general linear model on Intensity of alcohol demand including baseline urge to consume alcohol and AUDIT score as covariates. Here we report the results of the analysis of the effect of Time on Intensity for women in the sham DOMS group.||||.49
71851354|NCT02790788|143217101|SUPERIORITY||Mean Difference (Net)|3.3|STANDARD_ERROR_OF_MEAN|4.3||0.44|TWO_SIDED|95.0|-5.2|11.8|||t-test, 2 sided|||Independent Samples t-test||11.8|-5.2|0.44
71851355|NCT02790788|143217103|SUPERIORITY||Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|3.6||0.17|TWO_SIDED|95.0|-2.2|12.2|||t-test, 2 sided|||||12.2|-2.2|0.17
71851356|NCT02790788|143217104|SUPERIORITY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.0||0.043|TWO_SIDED|95.0|0.4|20.8|||t-test, 2 sided|||||20.8|0.4|0.043
71851357|NCT02790788|143217105|SUPERIORITY||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|3.7||0.59|TWO_SIDED|95.0|-9.3|5.3|||t-test, 2 sided|||||5.3|-9.3|0.59
71851358|NCT02790788|143217106|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|2.0||0.64|TWO_SIDED|95.0|-3.1|5.0|||t-test, 2 sided|||||5.0|-3.1|0.64
71902118|NCT01763905|143325938|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-79.2|-58.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-58.4|-79.2|<0.001
71902119|NCT01763905|143325939|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|30.9|53.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||53.4|30.9|<0.001
71679780|NCT02783729|142877147|SUPERIORITY||LSGM Ratio|0.753|||<|0.0001|TWO_SIDED|95.0|0.689|0.823||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||0.823|0.689|< 0.0001
71819720|NCT03688711|143141984|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Assessed at 15 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71819721|NCT03688711|143141984|SUPERIORITY|||||||0.0006|||||||Fisher Exact|||Assessed at 10 minutes. The recovery rates of dasiglucagon and placebo were compared at each time point using a Fisher's exact test. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||0.0006
71819722|NCT03688711|143141985|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 30 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71819723|NCT03688711|143141985|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 20 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71819724|NCT03688711|143141985|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 15 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71819725|NCT03688711|143141985|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||Change from baseline in plasma glucose at 10 minutes after investigational product injection was calculated using nominal sampling times and analyzed using an analysis of variance model with treatment, age group and injection site for each endpoint. Testing followed an a priori defined hierarchical inferential test order, proceeding until the first failure to reject the null hypothesis comparing dasiglucagon versus placebo.||||<0.0001
71819726|NCT03688711|143141986|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Evaluated using a Kaplan Meier (KM) approach, with treatment group as a stratification factor, analogous to that used for the primary endpoint analysis. Differences between the KM curves (dasiglucagon versus placebo) were evaluated inferentially using pairwise two-sided log-rank tests. Subjects whose time to first plasma glucose concentration ≥70 mg/dL (3.9 mmol/L) was not met within 45 minutes post-dosing were censored, at the time of the last valid plasma glucose measurement up to 45 minutes.||||<0.0001
71819727|NCT03688711|143141987|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.71|6.05|||ANCOVA|||The analysis was an analysis of covariance (ANCOVA) model with treatment group as factor and the baseline of the dependent variable plasma glucose as a covariate.||6.05|2.71|<0.0001
71851359|NCT02790788|143217107|SUPERIORITY||Mean Difference (Net)|-4.0|STANDARD_ERROR_OF_MEAN|3.0||0.2|TWO_SIDED|95.0|-10.1|2.1|||t-test, 2 sided|||||2.1|-10.1|0.20
71851360|NCT02790788|143217108|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|1.9||0.14|TWO_SIDED|95.0|-0.9|6.6|||t-test, 2 sided|||||6.6|-0.9|0.14
71851361|NCT02790788|143217109|SUPERIORITY||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|3.4||0.9|TWO_SIDED|95.0|-6.4|7.3|||t-test, 2 sided|||||7.3|-6.4|0.90
71902120|NCT01763905|143325939|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|42.0|||<|0.001|TWO_SIDED|95.0|30.3|51.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||51.8|30.3|<0.001
71679781|NCT02783729|142877147|SUPERIORITY||LSGM Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.671|0.837||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||0.837|0.671|< 0.0001
71851362|NCT02790788|143217110|SUPERIORITY||Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|2.2||0.33|TWO_SIDED|95.0|-2.2|6.4|||t-test, 2 sided|||||6.4|-2.2|0.33
71851363|NCT02790788|143217111|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|2.8||0.92|TWO_SIDED|95.0|-5.3|5.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA WITHIN 12 HOURS AFTER ROSC||5.8|-5.3|0.92
71851364|NCT02790788|143217111|SUPERIORITY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|1.3||0.54|TWO_SIDED|95.0|-3.4|1.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA WITHIN 12 HOURS AFTER ROSC||1.8|-3.4|0.54
71819728|NCT01950273|143141995|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) mean ratio|89.53|||||TWO_SIDED|90.0|75.42|106.29|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||106.29|75.42|
71819729|NCT01950273|143141996|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|94.6||||||90.0|85.04|105.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.23|85.04|
71819730|NCT01950273|143141997|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|89.94|||||TWO_SIDED|90.0|77.62|104.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||104.23|77.62|
71819731|NCT01950273|143141998|NON_INFERIORITY_OR_EQUIVALENCE|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|97.65|||||TWO_SIDED|90.0|90.45|105.42|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).|||105.42|90.45|
71819732|NCT01950273|143141999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|249.2|||||TWO_SIDED|90.0|-210.6|709.0|||||Mean difference calculated as BI 695500-Rituximab (MabThera®).|||709|-210.6|
71679782|NCT02783729|142877147|SUPERIORITY||LSGM Ratio|0.689|||<|0.0001|TWO_SIDED|95.0|0.618|0.769||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||0.769|0.618|< 0.0001
71819733|NCT01950273|143142001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|||||TWO_SIDED|95.0|-29.4|11.1|||||Difference in ORR calculated as ORR (BI695500) - ORR (MabThera®). The confidence interval represented is 95% difference in proportions.|||11.1|-29.4|
71819734|NCT01950273|143142002|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0|||||TWO_SIDED|95.0|-18.0|22.1|||||Difference in TEAE incidence calculated as BI695500 - TEAE incidence (MabThera®). The confidence interval represented is 95% difference in proportions.|||22.1|-18.0|
71851365|NCT02790788|143217111|SUPERIORITY||Mean Difference (Net)|4.6|STANDARD_ERROR_OF_MEAN|2.17||0.048|TWO_SIDED|95.0|0.04|9.15|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA AT 72 HOURS AFTER ROSC||9.15|0.04|0.048
71851366|NCT02790788|143217111|SUPERIORITY||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|1.4||0.18|TWO_SIDED|95.0|-1.0|4.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA AT 72 HOURS AFTER ROSC||4.7|-1.0|0.18
71851367|NCT02790788|143217112|SUPERIORITY||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|3.6||0.32|TWO_SIDED|95.0|-10.9|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF WITHIN 12 HOURS AFTER ROSC||3.7|-10.9|0.32
71851368|NCT02790788|143217112|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.1||0.76|TWO_SIDED|95.0|-7.2|5.3|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 12 HOURS AFTER ROSC||5.3|-7.2|0.76
71851369|NCT02790788|143217112|SUPERIORITY||Mean Difference (Net)|-4.9|STANDARD_ERROR_OF_MEAN|4.2||0.25|TWO_SIDED|95.0|-13.5|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF AT 72 HOURS AFTER ROSC||3.7|-13.5|0.25
71851370|NCT02790788|143217112|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|3.5||0.61|TWO_SIDED|95.0|-9.1|5.5|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 72 HOURS AFTER ROSC||5.5|-9.1|0.61
71851371|NCT02790788|143217113|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED|95.0|-0.25|0.11|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI WITHIN 12 HOURS OF ROSC.||0.11|-0.25|0.41
71851372|NCT02790788|143217113|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED|95.0|-0.26|0.1|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI WITHIN 12 HOURS AFTER ROSC.||0.10|-0.26|0.38
71851373|NCT02790788|143217113|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.46|TWO_SIDED|95.0|-0.29|0.14|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.14|-0.29|0.46
71851374|NCT02790788|143217113|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED|95.0|-0.33|0.12|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI AT 72 HOURS AFTER ROSC.||0.12|-0.33|0.34
71851375|NCT02790788|143217114|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.65||0.9|TWO_SIDED|95.0|-1.5|1.3|||t-test, 2 sided|||||1.3|-1.5|0.90
71851376|NCT02790788|143217115|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.37||0.59|TWO_SIDED|95.0|-0.54|0.94|||t-test, 2 sided|||||0.94|-0.54|0.59
71851377|NCT02790788|143217116|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.38||0.67|TWO_SIDED|95.0|-0.6|0.93|||t-test, 2 sided|||||0.93|-0.60|0.67
71851378|NCT02790788|143217117|SUPERIORITY||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.41||0.65|TWO_SIDED|95.0|-0.64|1.02|||t-test, 2 sided|||||1.02|-0.64|0.65
71851379|NCT02790788|143217118|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.41|TWO_SIDED|95.0|-1.2|2.8||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 0-6 HOURS AFTER ROSC.|t-test, 2 sided|||||2.8|-1.2|0.41
71851380|NCT02790788|143217118|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|95.0|-0.92|0.19|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.19|-0.92|0.20
71851381|NCT02790788|143217118|SUPERIORITY||Median Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.07|TWO_SIDED|95.0|-1.0|0.04|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.||0.04|-1.00|0.07
71851382|NCT02790788|143217118|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.29||0.36|TWO_SIDED|95.0|-0.85|0.31|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 18-24 HOURS AFTER ROSC.||0.31|-0.85|0.36
71851383|NCT02790788|143217118|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.25||0.54|TWO_SIDED|95.0|-0.66|0.35|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 24-30 HOURS AFTER ROSC.||0.35|-0.66|0.54
71851384|NCT02790788|143217118|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|95.0|-0.69|0.42|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 30-36 HOURS AFTER ROSC.||0.42|-0.69|0.62
71851385|NCT02790788|143217118|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|95.0|-0.71|0.41|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 36-42 HOURS AFTER ROSC.||0.41|-0.71|0.60
71851386|NCT02790788|143217118|SUPERIORITY||Median Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.69|0.36|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 42-48 HOURS AFTER ROSC.||0.36|-0.69|0.54
71851387|NCT02790788|143217119|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|0.87||0.42|TWO_SIDED|95.0|-2.5|1.1|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||1.1|-2.5|0.42
71851388|NCT02790788|143217119|SUPERIORITY||Median Difference (Net)|0.68|STANDARD_ERROR_OF_MEAN|0.79||0.4|TWO_SIDED|95.0|-0.94|2.3|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 96.0 MMHG||2.30|-0.94|0.40
71851389|NCT02790788|143217119|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.15||0.44|TWO_SIDED|95.0|-1.49|3.28|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG||3.28|-1.49|0.44
71851390|NCT02790788|143217119|SUPERIORITY||Median Difference (Net)|1.15|STANDARD_ERROR_OF_MEAN|1.23||0.36|TWO_SIDED|95.0|-1.4|3.7|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 97.0 MMHG||3.70|-1.40|0.36
71851391|NCT02790788|143217120|SUPERIORITY|||||||0.84|||||||Mann Whitney|||||||0.84
71902121|NCT01763905|143325940|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|48.0|||<|0.001|TWO_SIDED|95.0|35.0|57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||57.8|35.0|<0.001
71902122|NCT01763905|143325940|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|37.5|||<|0.001|TWO_SIDED|95.0|25.5|47.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.||||47.5|25.5|<0.001
71902123|NCT01763905|143325941|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.53|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-36.34|-26.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.73|-36.34|<0.001
71902124|NCT01763905|143325941|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.58|STANDARD_ERROR_OF_MEAN|2.05|<|0.001|TWO_SIDED|95.0|-38.63|-30.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.54|-38.63|<0.001
71902125|NCT01763905|143325942|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.09|STANDARD_ERROR_OF_MEAN|2.63|<|0.001|TWO_SIDED|95.0|-37.28|-26.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-26.90|-37.28|<0.001
71902126|NCT01763905|143325942|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.99|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-37.19|-28.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.79|-37.19|<0.001
71902127|NCT01763905|143325943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.2|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-36.92|-27.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.49|-36.92|<0.001
71902128|NCT01763905|143325943|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-39.59|-30.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-30.39|-39.59|<0.001
71902129|NCT01763905|143325944|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.86|STANDARD_ERROR_OF_MEAN|2.62|<|0.001|TWO_SIDED|95.0|-38.04|-27.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-27.68|-38.04|<0.001
71902130|NCT01763905|143325944|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.1|STANDARD_ERROR_OF_MEAN|2.5|<|0.001|TWO_SIDED|95.0|-38.04|-28.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.17|-38.04|<0.001
71902131|NCT01763905|143325945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.39|STANDARD_ERROR_OF_MEAN|2.39|<|0.001|TWO_SIDED|95.0|-32.11|-22.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-22.67|-32.11|<0.001
71902132|NCT01763905|143325945|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.94|STANDARD_ERROR_OF_MEAN|2.42|<|0.001|TWO_SIDED|95.0|-34.72|-25.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-25.17|-34.72|<0.001
71902133|NCT01763905|143325946|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.28|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-31.42|-21.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-21.15|-31.42|<0.001
71679783|NCT02783729|142877147|SUPERIORITY||LSM Difference|-12.41|STANDARD_ERROR_OF_MEAN|4.764|=|0.0093|TWO_SIDED|95.0|-21.76|-3.06||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 5 mg||-3.06|-21.76|= 0.0093
71679784|NCT02783729|142877147|SUPERIORITY||LSM Difference|-26.34|STANDARD_ERROR_OF_MEAN|4.762|<|0.0001|TWO_SIDED|95.0|-35.68|-16.99||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||-16.99|-35.68|< 0.0001
71902134|NCT01763905|143325946|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.66|STANDARD_ERROR_OF_MEAN|2.64|<|0.001|TWO_SIDED|95.0|-33.88|-23.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-23.43|-33.88|<0.001
71679785|NCT02783729|142877147|SUPERIORITY||LSM Difference|-11.49|STANDARD_ERROR_OF_MEAN|5.573|=|0.0396|TWO_SIDED|95.0|-22.42|-0.55||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||-0.55|-22.42|= 0.0396
71679786|NCT02783729|142877147|SUPERIORITY||LSM Difference|-20.57|STANDARD_ERROR_OF_MEAN|5.574|=|0.0002|TWO_SIDED|95.0|-31.51|-9.63||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||-9.63|-31.51|= 0.0002
71679787|NCT02783729|142877147|SUPERIORITY||LSM Difference|19.05|STANDARD_ERROR_OF_MEAN|5.619|=|0.0007|TWO_SIDED|95.0|8.03|30.08||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 5 mg||30.08|8.03|= 0.0007
71679788|NCT02783729|142877147|SUPERIORITY||LSM Difference|34.51|STANDARD_ERROR_OF_MEAN|5.609|<|0.0001|TWO_SIDED|95.0|23.5|45.52||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 10 mg||45.52|23.5|< 0.0001
71679789|NCT02783729|142877147|SUPERIORITY||LSM Difference|23.57|STANDARD_ERROR_OF_MEAN|6.565|=|0.0003|TWO_SIDED|95.0|10.68|36.45||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 5 mg||36.45|10.68|= 0.0003
71819735|NCT01254565|143142003|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-76.9|||<|0.0001|TWO_SIDED|95.0|-86.9|-50.0|||ANOVA|A rank analysis of variance (ANOVA) model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-50.0|-86.9|<0.0001
71819736|NCT01254565|143142003|SUPERIORITY|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-36.7||||0.0032|TWO_SIDED|95.0|-59.8|-13.6|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.||-13.6|-59.8|0.0032
71819737|NCT01254565|143142004|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71819738|NCT01254565|143142004|SUPERIORITY|||||||0.0968|||||||Fisher Exact|||||||0.0968
71819739|NCT01254565|143142005|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71819740|NCT01254565|143142005|SUPERIORITY|||||||0.073|||||||Fisher Exact|||||||0.0730
71851392|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.144||0.86|TWO_SIDED|95.0|-0.311|0.262|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 4 HOURS AFTER ROSC||0.262|-0.311|0.86
71851393|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.064|STANDARD_ERROR_OF_MEAN|0.111||0.56|TWO_SIDED|95.0|-0.287|0.158|||t-test, 2 sided|||RESULTS CORRESPOND TO TNF-α AT 4 HOURS AFTER ROSC||0.158|-0.287|0.56
71679790|NCT02783729|142877147|SUPERIORITY||LSM Difference|37.82|STANDARD_ERROR_OF_MEAN|6.565|<|0.0001|TWO_SIDED|95.0|24.94|50.71||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 10 mg||50.71|24.94|< 0.0001
71679791|NCT02783729|142877148|SUPERIORITY||LSM Difference|3.76|STANDARD_ERROR_OF_MEAN|1.122|=|0.0008|TWO_SIDED|95.0|1.56|5.97||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 5 mg||5.97|1.56|= 0.0008
71819741|NCT01254565|143142006|SUPERIORITY||LS Mean Difference|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.4|-8.4|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-8.4|-16.4|< 0.0001
71851394|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.034|STANDARD_ERROR_OF_MEAN|0.053||0.52|TWO_SIDED|95.0|-0.071|0.139|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 4 HOURS AFTER ROSC||0.139|-0.071|0.52
71819742|NCT01254565|143142006|SUPERIORITY||LS Mean Difference|-6.9||||0.0235|TWO_SIDED|95.0|-12.8|-1.0|||ANOVA|ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.0|-12.8|0.0235
71819743|NCT01254565|143142007|SUPERIORITY||LS Mean Difference|-4.2||||0.2255|TWO_SIDED|95.0|-18.6|5.7|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.7|-18.6|0.2255
71819744|NCT01254565|143142007|SUPERIORITY||LS mean Difference|-21.8||||0.1751|TWO_SIDED|95.0|-29.8|5.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||5.9|-29.8|0.1751
71819745|NCT01254565|143142008|SUPERIORITY||LS Mean Difference|-11.2||||0.0112|TWO_SIDED|95.0|-26.8|-4.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-4.9|-26.8|0.0112
71819746|NCT01254565|143142008|SUPERIORITY||LS Mean Difference|-27.7||||0.0554|TWO_SIDED|95.0|-39.3|-1.6|||ANOVA|A rank ANOVA model with treatment and screening PTH (\< 600 or ≥ 600 pg/mL) as factors.||||-1.6|-39.3|0.0554
71819747|NCT03354637|143142040|SUPERIORITY||Mean Difference (Final Values)|13.88|STANDARD_ERROR_OF_MEAN|4.707||0.038|TWO_SIDED|95.0|0.77|27.0||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||27.00|0.77|0.038
71851395|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.041|STANDARD_ERROR_OF_MEAN|0.107||0.7|TWO_SIDED|95.0|-0.254|0.172|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 4 HOURS AFTER ROSC||0.172|-0.254|0.70
71851396|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.007|STANDARD_ERROR_OF_MEAN|0.167||0.97|TWO_SIDED|95.0|-0.326|0.34|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 4 HOURS AFTER ROSC||0.340|-0.326|0.97
71679792|NCT02783729|142877148|SUPERIORITY||LSM Difference|6.84|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|4.64|9.04||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 10 mg||9.04|4.64|< 0.0001
71851397|NCT02790788|143217121|SUPERIORITY||Median Difference (Net)|0.067|STANDARD_ERROR_OF_MEAN|0.129||0.61|TWO_SIDED|95.0|-0.192|0.326|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 24 HOURS AFTER ROSC||0.326|-0.192|0.61
71851398|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.014|STANDARD_ERROR_OF_MEAN|0.126||0.91|TWO_SIDED|95.0|-0.238|0.267|||t-test, 2 sided|||RESULTS CORRESPOND TO TNFα AT 24 HOURS AFTER ROSC||0.267|-0.238|0.91
71851399|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.19|TWO_SIDED|95.0|-0.1|0.021|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 24 HOURS AFTER ROSC||0.021|-0.100|0.19
71851400|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.022|STANDARD_ERROR_OF_MEAN|0.111||0.85|TWO_SIDED|95.0|-0.244|0.201|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 24 HOURS AFTER ROSC||0.201|-0.244|0.85
71851401|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.162||0.37|TWO_SIDED|95.0|-0.179|0.473|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 24 HOURS AFTER ROSC||0.473|-0.179|0.37
71902135|NCT01763905|143325947|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.86|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-39.84|-29.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.88|-39.84|<0.001
71902136|NCT01763905|143325947|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.37|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-41.73|-31.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-31.01|-41.73|<0.001
71902137|NCT01763905|143325948|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-40.05|-29.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-29.00|-40.05|<0.001
71902138|NCT01763905|143325948|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.13|STANDARD_ERROR_OF_MEAN|2.91|<|0.001|TWO_SIDED|95.0|-39.87|-28.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-28.39|-39.87|<0.001
71851402|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.127||0.74|TWO_SIDED|95.0|-0.298|0.212|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 48 HOURS AFTER ROSC||0.212|-0.298|0.74
71851403|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.036|STANDARD_ERROR_OF_MEAN|0.14||0.8|TWO_SIDED|95.0|-0.246|0.318|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 48 HOURS AFTER ROSC||0.318|-0.246|0.80
71902139|NCT01763905|143325949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.9|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-31.27|-16.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.54|-31.27|<0.001
71851404|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.056|STANDARD_ERROR_OF_MEAN|0.043||0.2|TWO_SIDED|95.0|-0.03|0.142|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 48 HOURS AFTER ROSC||0.142|-0.030|0.20
71851405|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.111||0.83|TWO_SIDED|95.0|-0.246|0.198|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 48 HOURS AFTER ROSC||0.198|-0.246|0.83
71851406|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.027|STANDARD_ERROR_OF_MEAN|0.124||0.83|TWO_SIDED|95.0|-0.223|0.276|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 48 HOURS AFTER ROSC||0.276|-0.223|0.83
71851407|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.161||0.85|TWO_SIDED|95.0|-0.294|0.354|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 72 HOURS AFTER ROSC||0.354|-0.294|0.85
71902140|NCT01763905|143325949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.26|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-33.75|-16.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.77|-33.75|<0.001
71902141|NCT01763905|143325950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.29|STANDARD_ERROR_OF_MEAN|4.03|<|0.001|TWO_SIDED|95.0|-33.26|-17.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-17.33|-33.26|<0.001
71851408|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.048|STANDARD_ERROR_OF_MEAN|0.145||0.74|TWO_SIDED|95.0|-0.243|0.339|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 72 HOURS AFTER ROSC||0.339|-0.243|0.74
71851409|NCT02790788|143217121|SUPERIORITY||Median Difference (Net)|0.013|STANDARD_ERROR_OF_MEAN|0.039||0.75|TWO_SIDED|95.0|-0.066|0.091|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 72 HOURS AFTER ROSC||0.091|-0.066|0.75
71851410|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.096||0.64|TWO_SIDED|95.0|-0.238|0.149|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 72 HOURS AFTER ROSC||0.149|-0.238|0.64
71851411|NCT02790788|143217121|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.147||0.23|TWO_SIDED|95.0|-0.116|0.475|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 72 HOURS AFTER ROSC||0.475|-0.116|0.23
71851412|NCT02790788|143217122|SUPERIORITY||Percent Difference|4.9||||0.45|TWO_SIDED|95.0|-4.8|14.6|||Fisher Exact|||||14.6|-4.8|0.45
71679793|NCT02783729|142877148|SUPERIORITY||LSM Difference|4.61|STANDARD_ERROR_OF_MEAN|1.319|=|0.0005|TWO_SIDED|95.0|2.02|7.19||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 5 mg||7.19|2.02|= 0.0005
71679794|NCT02783729|142877148|SUPERIORITY||LSM Difference|7.18|STANDARD_ERROR_OF_MEAN|1.319|<|0.0001|TWO_SIDED|95.0|4.6|9.77||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 10 mg||9.77|4.6|< 0.0001
71679795|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|0.41|||=|0.9028|TWO_SIDED|95.0|-6.22|7.04||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 5 mg||7.04|-6.22|= 0.9028
71679796|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|2.49|||=|0.4699|TWO_SIDED|95.0|-4.2|9.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 10 mg||9.18|-4.2|= 0.4699
71819748|NCT03354637|143142040|SUPERIORITY||Mean Difference (Final Values)|9.32|STANDARD_ERROR_OF_MEAN|4.784||0.166|TWO_SIDED|95.0|-3.9|22.55||All statistical testing was two-sided and performed using a significance (alpha) level of 0.05.|Mixed Models Analysis|||Since this was the first multicenter study evaluating the effect of ATI-50002 Topical Solution in subjects with stable patchy alopecia areata, the sample size was based upon feasibility issues rather than a formal power calculation. Planned data from 120 subjects, utilizing LOCF for missing data, provides 80% power to detect a 24-point difference in percent change from baseline in SALT score between any two treatment groups. This power computation is based upon assumed standard deviation of 38%.||22.55|-3.90|0.166
71819749|NCT03354637|143142041|SUPERIORITY||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.511||0.302|TWO_SIDED|95.0|-5.97|19.17|||Mixed Models Analysis|||||19.17|-5.97|0.302
71819750|NCT03354637|143142041|SUPERIORITY||Mean Difference (Final Values)|3.23|STANDARD_ERROR_OF_MEAN|4.584||0.616|TWO_SIDED|95.0|-9.44|15.9|||Mixed Models Analysis|||||15.90|-9.44|0.616
71819751|NCT03354637|143142042|SUPERIORITY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|2.074||0.125|TWO_SIDED|95.0|-1.26|10.3|||Mixed Models Analysis|||||10.30|-1.26|0.125
71819752|NCT03354637|143142042|SUPERIORITY||Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|2.107||0.234|TWO_SIDED|95.0|-2.3|9.36|||Mixed Models Analysis|||||9.36|-2.30|0.234
71819753|NCT03354637|143142043|SUPERIORITY||Mean Difference (Final Values)|1.55|STANDARD_ERROR_OF_MEAN|2.131||0.607|TWO_SIDED|95.0|-4.39|7.49|||Mixed Models Analysis|||||7.49|-4.39|0.607
71819754|NCT03354637|143142043|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.165||0.981|TWO_SIDED|95.0|-6.06|5.92|||Mixed Models Analysis|||||5.92|-6.06|0.981
71851413|NCT02790788|143217123|SUPERIORITY||Mann-Whitney U|50903.5||||0.68|TWO_SIDED||||||Mann Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERGLYCEMIA||||0.68
71851414|NCT02790788|143217123|SUPERIORITY||Mann Whitney U|52188.5||||0.68|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERNATREMIA||||0.68
71679797|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|5.58|||=|0.0566|TWO_SIDED|95.0|-0.14|11.31|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by age group.||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg||11.31|-0.14|= 0.0566
71679798|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|7.57|||=|0.0122|TWO_SIDED|95.0|1.71|13.44||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg||13.44|1.71|= 0.0122
71679799|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|4.42|||=|0.2176|TWO_SIDED|95.0|-2.5|11.34||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 5 mg||11.34|-2.5|= 0.2176
71819755|NCT03354637|143142044|SUPERIORITY||Odds Ratio (OR)|1.4||||0.62|TWO_SIDED|95.0|0.4|4.6|||Mixed Models Analysis|||||4.6|0.4|0.620
71819756|NCT03354637|143142044|SUPERIORITY||Odds Ratio (OR)|1.7||||0.366|TWO_SIDED|95.0|0.5|5.8|||Mixed Models Analysis|||||5.8|0.5|0.366
71819757|NCT03354637|143142045|SUPERIORITY||Odds Ratio (OR)|0.1||||0.157|TWO_SIDED|95.0|0.0|2.3|||Mixed Models Analysis|||||2.3|0.0|0.157
71819758|NCT03354637|143142045|SUPERIORITY||Odds Ratio (OR)|0.4||||0.353|TWO_SIDED|95.0|0.1|2.8|||Mixed Models Analysis|||||2.8|0.1|0.353
71819759|NCT03354637|143142046|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
71819760|NCT03354637|143142046|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
71819761|NCT03354637|143142047|SUPERIORITY||Odds Ratio (OR)|0.7||||0.435|TWO_SIDED|95.0|0.3|1.8|||Mixed Models Analysis|||||1.8|0.3|0.435
71819762|NCT03354637|143142047|SUPERIORITY||Odds Ratio (OR)|0.6||||0.37|TWO_SIDED|95.0|0.2|1.7|||Mixed Models Analysis|||||1.7|0.2|0.370
71819763|NCT03354637|143142048|SUPERIORITY||Odds Ratio (OR)|1.7||||0.333|TWO_SIDED|95.0|0.6|5.4|||Mixed Models Analysis|||||5.4|0.6|0.333
71819764|NCT03354637|143142048|SUPERIORITY||Odds Ratio (OR)|1.7||||0.388|TWO_SIDED|95.0|0.5|5.2|||Mixed Models Analysis|||||5.2|0.5|0.388
71819765|NCT03354637|143142049|SUPERIORITY|||||||0.505|||||||Wilcoxon (Mann-Whitney)|||||||0.505
71819766|NCT03354637|143142049|SUPERIORITY|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||||||0.359
71819767|NCT03354637|143142050|SUPERIORITY|||||||0.602|||||||Wilcoxon (Mann-Whitney)|||||||0.602
71819768|NCT03354637|143142050|SUPERIORITY|||||||0.643|||||||Wilcoxon (Mann-Whitney)|||||||0.643
71819769|NCT03354637|143142051|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||||||0.992
71819770|NCT03354637|143142051|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
71819771|NCT03354637|143142053|SUPERIORITY|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||||||0.374
71819772|NCT03354637|143142053|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
71819773|NCT03354637|143142055|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||||||0.102
71819774|NCT03354637|143142055|SUPERIORITY|||||||0.859|||||||Wilcoxon (Mann-Whitney)|||||||0.859
71851415|NCT02790788|143217123|SUPERIORITY||Mann-Whitney U|1128.5||||0.37|TWO_SIDED||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF INFECTION||||0.37
71851416|NCT00760877|143217163|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.096||||0.1083|TWO_SIDED|95.0|0.766|5.738|||Cochran-Mantel-Haenszel|||||5.738|0.766|0.1083
71902142|NCT01763905|143325950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.88|STANDARD_ERROR_OF_MEAN|5.73|<|0.001|TWO_SIDED|95.0|-39.21|-16.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||-16.56|-39.21|<0.001
71819775|NCT03354637|143142056|SUPERIORITY|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
71819776|NCT03354637|143142056|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
71819777|NCT02564055|143142065|OTHER||Difference in percentages|22.6|||||TWO_SIDED|95.0|-2.4|45.5|||||Difference between GSK2894512 1 percent BID and Vehicle BID has been presented.|||45.5|-2.4|
71819778|NCT02564055|143142065|OTHER||Difference in percentages|7.4|||||TWO_SIDED|95.0|-18.3|32.0|||||Difference between GSK2894512 1 percent QD and Vehicle QD has been presented.|||32.0|-18.3|
71819779|NCT02564055|143142065|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-11.2|38.7|||||Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented.|||38.7|-11.2|
71819780|NCT02564055|143142065|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-29.3|21.6|||||Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented.|||21.6|-29.3|
71851417|NCT00946998|143217182|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
71851418|NCT00946998|143217183|SUPERIORITY|||||||0.28||||||Represents the response outcome.|Mixed Models Analysis|||||||0.28
71851419|NCT00946998|143217183|SUPERIORITY|||||||0.86||||||Represents remission outcome.|Mixed Models Analysis|||||||0.86
71851420|NCT00946998|143217184|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
71851421|NCT00946998|143217185|SUPERIORITY|||||||0.61|||||||Mixed Models Analysis|||||||0.61
71851422|NCT00946998|143217186|SUPERIORITY||||||>|0.99||||||For death|Chi-squared|||||||>.99
71819781|NCT02564055|143142073|OTHER||Difference in percentages|21.1|||||TWO_SIDED|95.0|-2.7|43.1|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||43.1|-2.7|
71819782|NCT02564055|143142073|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|3.3|47.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||47.5|3.3|
71819783|NCT02564055|143142073|OTHER||Difference in percentages|2.3|||||TWO_SIDED|95.0|-19.5|24.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 1 has been presented.|||24.5|-19.5|
71819784|NCT02564055|143142073|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-14.5|32.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||32.0|-14.5|
71819785|NCT02564055|143142073|OTHER||Difference in percentages|23.1|||||TWO_SIDED|95.0|-0.3|44.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||44.6|-0.3|
71819786|NCT02564055|143142073|OTHER||Difference in percentages|37.7|||||TWO_SIDED|95.0|14.7|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||57.6|14.7|
71819787|NCT02564055|143142073|OTHER||Difference in percentages|5.1|||||TWO_SIDED|95.0|-18.0|27.8|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||27.8|-18.0|
71819788|NCT02564055|143142073|OTHER||Difference in percentages|17.1|||||TWO_SIDED|95.0|-6.4|39.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.0|-6.4|
71819789|NCT02564055|143142073|OTHER||Difference in percentages|39.6|||||TWO_SIDED|95.0|16.0|60.0|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||60.0|16.0|
71819790|NCT02564055|143142073|OTHER||Difference in percentages|31.2|||||TWO_SIDED|95.0|7.8|52.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||52.1|7.8|
71819791|NCT02564055|143142073|OTHER||Difference in percentages|26.5|||||TWO_SIDED|95.0|2.3|48.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||48.4|2.3|
71819792|NCT02564055|143142073|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-5.3|40.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||40.5|-5.3|
71819793|NCT02564055|143142073|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-2.3|44.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||44.7|-2.3|
71819794|NCT02564055|143142073|OTHER||Difference in percentages|36.3|||||TWO_SIDED|95.0|12.1|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||57.6|12.1|
71819795|NCT02564055|143142073|OTHER||Difference in percentages|26.7|||||TWO_SIDED|95.0|1.7|49.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||49.0|1.7|
71819796|NCT02564055|143142073|OTHER||Difference in percentages|23.4|||||TWO_SIDED|95.0|-1.5|46.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||46.1|-1.5|
71851423|NCT00946998|143217186|SUPERIORITY|||||||0.77||||||For comparison of dialysis initiation between groups.|Chi-squared|||||||0.77
71851424|NCT00946998|143217186|SUPERIORITY||||||>|0.99||||||Hospitalization other than dialysis initiation|Chi-squared|||||||>0.99
71851425|NCT00946998|143217186|SUPERIORITY|||||||0.5||||||For comparison of acute suicidal intent.|Chi-squared|||||||0.5
71851426|NCT00946998|143217186|SUPERIORITY||||||>|0.99||||||For comparison of bleeding requiring blood transfusion or hospitalization.|Chi-squared|||||||>0.99
71851427|NCT00409006|143217192|SUPERIORITY_OR_OTHER|||||||0.0618||95.0|||||Log Rank|||||||0.0618
71851428|NCT00409006|143217193|SUPERIORITY_OR_OTHER|||||||0.369||95.0|||||Regression, Logistic|Used the Wald Chi-squared statistic from a logistic regression analysis.||||||0.369
71851429|NCT04694300|143217232|SUPERIORITY|Lower the maximum pain intensity score the more effective the analgesic|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71851430|NCT04694300|143217233|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71851431|NCT04694300|143217234|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71851432|NCT04694300|143217235|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71851433|NCT04694300|143217238|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71851434|NCT04694300|143217239|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71851435|NCT04694300|143217240|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|Higher percentage inhibition relates to greater selectivity for COX-2||||||0.59
71851436|NCT04694300|143217241|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71819797|NCT02564055|143142073|OTHER||Difference in percentages|19.0|||||TWO_SIDED|95.0|-6.0|42.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||42.3|-6.0|
71679800|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|6.47|||=|0.0773|TWO_SIDED|95.0|-0.55|13.49||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 10 mg||13.49|-0.55|= 0.0773
71851437|NCT01263223|143217255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||<|0.0001|TWO_SIDED|95.0|7.4|12.0||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||12.0|7.4|<0.0001
71851438|NCT01263223|143217255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.4|||<|0.0001|TWO_SIDED|95.0|17.9|30.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||30.9|17.9|<0.0001
71851439|NCT01263223|143217256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||8.8|3.9|<0.0001
71851440|NCT01263223|143217256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.0025|TWO_SIDED|95.0|2.6|11.6||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||11.6|2.6|0.0025
71851441|NCT01263223|143217256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.51|||<|0.0001|TWO_SIDED|95.0|3.81|7.21||P-value is for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||7.21|3.81|<0.0001
71851442|NCT01263223|143217256|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66||||0.002|TWO_SIDED|95.0|2.13|9.2||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||9.20|2.13|0.0020
71851443|NCT01263223|143217257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9||||0.0224|TWO_SIDED|95.0|0.418|5.38||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis|||||5.38|0.418|0.0224
71851444|NCT01263223|143217257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7||||0.2453|TWO_SIDED|95.0|-1.88|7.29||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis|||||7.29|-1.88|0.2453
71851445|NCT01263223|143217257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||<|0.0001|TWO_SIDED|95.0|3.37|6.82||P-value if for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis|||||6.82|3.37|<0.0001
71851446|NCT01263223|143217257|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.53||||0.0005|TWO_SIDED|95.0|2.95|10.1||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis|||||10.1|2.95|0.0005
71851447|NCT01263223|143217258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.8|||<|0.0001|TWO_SIDED|95.0|8.7|16.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||16.9|8.7|<0.0001
71851448|NCT01263223|143217258|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.0||||0.0001|TWO_SIDED|95.0|11.4|34.5||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.5|11.4|0.0001
71819798|NCT02564055|143142073|OTHER||Difference in percentages|-0.2|||||TWO_SIDED|95.0|-25.0|25.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||25.0|-25.0|
71819799|NCT02564055|143142073|OTHER||Difference in percentages|32.6|||||TWO_SIDED|95.0|6.9|55.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||55.0|6.9|
71819800|NCT02564055|143142073|OTHER||Difference in percentages|-9.7|||||TWO_SIDED|95.0|-34.6|16.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||16.1|-34.6|
71851449|NCT01263223|143217259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.212|TWO_SIDED|95.0|-1.6|7.2||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||7.2|-1.6|0.2120
71851450|NCT01263223|143217259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6||||0.064|TWO_SIDED|95.0|-0.4|15.5||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||15.5|-0.4|0.0640
71851451|NCT01263223|143217259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.0211|TWO_SIDED|95.0|0.5|6.7||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.7|0.5|0.0211
71851452|NCT01263223|143217259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.8719|TWO_SIDED|95.0|-5.7|6.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||6.8|-5.7|0.8719
71851453|NCT01263223|143217260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.7133|TWO_SIDED|95.0|-5.3|3.7||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||3.7|-5.3|0.7133
71851454|NCT01263223|143217260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.4638|TWO_SIDED|95.0|-17.2|7.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||7.9|-17.2|0.4638
71851455|NCT01263223|143217261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.6|||<|0.0001|TWO_SIDED|95.0|11.3|15.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis|||||15.9|11.3|<0.0001
71851456|NCT01263223|143217261|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.6|||<|0.0001|TWO_SIDED|95.0|21.1|34.2||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis|||||34.2|21.1|<0.0001
71851457|NCT01263223|143217262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.9609|TWO_SIDED|95.0|-4.9|4.7||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis|||||4.7|-4.9|0.9609
71851458|NCT01263223|143217262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.2731|TWO_SIDED|95.0|-3.9|13.6||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis|||||13.6|-3.9|0.2731
71851459|NCT01263223|143217262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3779|TWO_SIDED|95.0|-4.8|1.8||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis|||||1.8|-4.8|0.3779
71851460|NCT01263223|143217262|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0||||0.0828|TWO_SIDED|95.0|-12.8|0.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis|||||0.8|-12.8|0.0828
71851461|NCT04387773|143217263|SUPERIORITY||Mean Difference (Final Values)|2.3|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
71851462|NCT04387773|143217264|SUPERIORITY||Mean Difference (Final Values)|14.98|||>|0.05|TWO_SIDED||||||t-test, 2 sided|||We hypothesized that GOCOVRI would result in an increase of daily activity due to improvement in LID symptoms.||||>.05
71851463|NCT04387773|143217265|SUPERIORITY||Mean Difference (Final Values)|2393.2||||0.037|TWO_SIDED||||||t-test, 2 sided|||||||0.037
71851464|NCT04387773|143217266|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.012|TWO_SIDED||||||t-test, 2 sided|||||||0.012
71851465|NCT04387773|143217267|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71902143|NCT01763905|143325951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.59|STANDARD_ERROR_OF_MEAN|4.45||0.97|TWO_SIDED|95.0|-11.38|6.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.20|-11.38|0.97
71902144|NCT01763905|143325951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-6.42|STANDARD_ERROR_OF_MEAN|5.13||0.33|TWO_SIDED|95.0|-16.55|3.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||3.71|-16.55|0.33
71819801|NCT02564055|143142073|OTHER||Difference in percentages|22.3|||||TWO_SIDED|95.0|-3.1|45.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||45.3|-3.1|
71819802|NCT02564055|143142073|OTHER||Difference in percentages|6.3|||||TWO_SIDED|95.0|-19.5|31.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||31.5|-19.5|
71819803|NCT02564055|143142073|OTHER||Difference in percentages|17.7|||||TWO_SIDED|95.0|-8.4|41.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||41.9|-8.4|
71851466|NCT00896389|143217276|OTHER|Association between genotypes and phenotypes were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71851467|NCT00896389|143217277|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||<|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||||||<0.05
71679801|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|8.85|||=|0.0054|TWO_SIDED|95.0|2.68|15.02||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg||15.02|2.68|= 0.0054
71819804|NCT02564055|143142073|OTHER||Difference in percentages|7.8|||||TWO_SIDED|95.0|-17.8|33.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||33.1|-17.8|
71819805|NCT02564055|143142073|OTHER||Difference in percentages|9.8|||||TWO_SIDED|95.0|-15.5|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||33.9|-15.5|
71819806|NCT02564055|143142073|OTHER||Difference in percentages|5.8|||||TWO_SIDED|95.0|-19.7|30.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||30.5|-19.7|
71819807|NCT02564055|143142073|OTHER||Difference in percentages|17.2|||||TWO_SIDED|95.0|-9.0|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.0|
71819808|NCT02564055|143142073|OTHER||Difference in percentages|-0.6|||||TWO_SIDED|95.0|-26.0|25.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||25.0|-26.0|
71819809|NCT02564055|143142073|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
71819810|NCT02564055|143142073|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
71851468|NCT00896389|143217278|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
71851469|NCT00896389|143217279|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
71679802|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|10.89|||=|0.0008|TWO_SIDED|95.0|4.61|17.17||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg||17.17|4.61|= 0.0008
71819811|NCT02564055|143142073|OTHER||Difference in percentages|28.6|||||TWO_SIDED|95.0|-19.2|71.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||71.0|-19.2|
71819812|NCT02564055|143142073|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
71819813|NCT02564055|143142074|OTHER||Difference in percentages|5.3|||||TWO_SIDED|95.0|-18.3|28.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||28.4|-18.3|
71819814|NCT02564055|143142074|OTHER||Difference in percentages|5.9|||||TWO_SIDED|95.0|-17.1|28.4|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.|||28.4|-17.1|
71819815|NCT02564055|143142074|OTHER||Difference in percentages|-0.8|||||TWO_SIDED|95.0|-24.0|22.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.|||22.7|-24.0|
71851470|NCT00896389|143217280|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.||||>0.05
71851471|NCT00896389|143217281|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71851472|NCT00896389|143217282|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71851473|NCT00896389|143217283|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71851474|NCT00896389|143217284|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71819816|NCT02564055|143142074|OTHER||Difference in percentages|11.4|||||TWO_SIDED|95.0|-12.0|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.|||33.9|-12.0|
71819817|NCT02564055|143142074|OTHER||Difference in percentages|30.2|||||TWO_SIDED|95.0|6.8|51.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.|||51.0|6.8|
71819818|NCT02564055|143142074|OTHER||Difference in percentages|3.7|||||TWO_SIDED|95.0|-19.4|26.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.|||26.6|-19.4|
71819819|NCT02564055|143142074|OTHER||Difference in percentages|17.4|||||TWO_SIDED|95.0|-6.0|39.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.|||39.5|-6.0|
71819820|NCT02564055|143142074|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-7.1|39.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.|||39.4|-7.1|
71819821|NCT02564055|143142074|OTHER||Difference in percentages|41.9|||||TWO_SIDED|95.0|19.2|61.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.|||61.2|19.2|
71819822|NCT02564055|143142074|OTHER||Difference in percentages|8.9|||||TWO_SIDED|95.0|-14.9|32.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.|||32.0|-14.9|
71819823|NCT02564055|143142074|OTHER||Difference in percentages|16.3|||||TWO_SIDED|95.0|-7.3|38.3|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.|||38.3|-7.3|
71819824|NCT02564055|143142074|OTHER||Difference in percentages|13.4|||||TWO_SIDED|95.0|-11.3|36.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.|||36.5|-11.3|
71819825|NCT02564055|143142074|OTHER||Difference in percentages|30.8|||||TWO_SIDED|95.0|6.1|52.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.|||52.8|6.1|
71819826|NCT02564055|143142074|OTHER||Difference in percentages|21.9|||||TWO_SIDED|95.0|-3.0|44.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.|||44.9|-3.0|
71819827|NCT02564055|143142074|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-13.5|34.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.|||34.7|-13.5|
71851475|NCT00896389|143217285|OTHER|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age\^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05|||||||Chi-squared|Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.||||>0.05
71851476|NCT04239911|143217289|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|0.97||||0.974|TWO_SIDED|95.0|0.14|6.85|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of leaving their current job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||6.85|0.14|0.974
71851477|NCT04239911|143217289|EQUIVALENCE|A p\< 0.05 considered the threshold for statistical significance|Odds Ratio (OR)|0.8||||0.846|TWO_SIDED|95.0|0.08|7.72|||Regression, Logistic||The comparison group is enhanced usual care arm|"Outcome measures workers' intentions of searching for a new job. Responses included 7-point likert scale of very strongly disagree-very strongly agree. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare outcome between and within study arm. Mixed effects included a variable for time point (baseline/90 days), indicator for study arm, a study arm by time point interaction and subject random intercept."||7.72|0.08|0.846
71851478|NCT04239911|143217292|EQUIVALENCE|A p\<0.05 was considered the threshold for statistical significance.|Odds Ratio (OR)|0.18||||0.043|TWO_SIDED|95.0|0.03|0.94|||Regression, Logistic||The comparison group is enhanced usual care arm|"Preventable 911 calls if had been able to reach the doctor. Dichotomized into agree, strongly agree, and very strongly vs. all other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||0.94|0.03|0.043
71851479|NCT04239911|143217292|EQUIVALENCE|A p\<0.05 considered the threshold for statistical significance.|Odds Ratio (OR)|1.01||||0.99|TWO_SIDED|95.0|0.22|4.58|||Regression, Logistic|||"Preventable 911 calls if had been able to reach the nurse/supervisor. Dichotomized into agree, strongly agree, and very strongly vs. other responses. We used logistic mixed regression model to compare trajectory of all outcomes between and within study arms. Mixed effects included a fixed effects categorical variable for time point (baseline/90days), and indicator for study arm (enhanced usual care/intervention), a study arm by time point interaction and subject specific random intercept."||4.58|0.22|0.99
71851480|NCT01580306|143217293|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|113.57|STANDARD_DEVIATION|93.2|||TWO_SIDED|90.0|41.58|310.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||310.17|41.58|
71851481|NCT01580306|143217293|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|178.31|STANDARD_DEVIATION|78.9|||TWO_SIDED|90.0|85.23|373.03|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||373.03|85.23|
71851482|NCT01580306|143217293|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|169.21|STANDARD_DEVIATION|97.7|||TWO_SIDED|90.0|73.19|391.17|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||391.17|73.19|
71851483|NCT01580306|143217294|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|107.22|STANDARD_DEVIATION|107.7|||TWO_SIDED|90.0|35.16|327.01|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal||327.01|35.16|
71679803|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|6.9|||=|0.003|TWO_SIDED|95.0|2.66|11.14||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg||11.14|2.66|= 0.003
71819828|NCT02564055|143142074|OTHER||Difference in percentages|27.4|||||TWO_SIDED|95.0|2.5|49.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||49.9|2.5|
71819829|NCT02564055|143142074|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.0|40.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||40.7|-9.0|
71819830|NCT02564055|143142074|OTHER||Difference in percentages|29.5|||||TWO_SIDED|95.0|3.7|52.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||52.3|3.7|
71819831|NCT02564055|143142074|OTHER||Difference in percentages|5.7|||||TWO_SIDED|95.0|-20.1|30.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||30.9|-20.1|
71819832|NCT02564055|143142074|OTHER||Difference in percentages|9.3|||||TWO_SIDED|95.0|-16.2|33.8|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||33.8|-16.2|
71819833|NCT02564055|143142074|OTHER||Difference in percentages|12.6|||||TWO_SIDED|95.0|-13.4|37.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||37.3|-13.4|
71819834|NCT02564055|143142074|OTHER||Difference in percentages|27.0|||||TWO_SIDED|95.0|0.7|50.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||50.5|0.7|
71819835|NCT02564055|143142074|OTHER||Difference in percentages|0.4|||||TWO_SIDED|95.0|-25.6|25.6|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||25.6|-25.6|
71819836|NCT02564055|143142074|OTHER||Difference in percentages|2.6|||||TWO_SIDED|95.0|-22.6|27.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||27.6|-22.6|
71819837|NCT02564055|143142074|OTHER||Difference in percentages|6.9|||||TWO_SIDED|95.0|-18.7|31.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||31.7|-18.7|
71679804|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|7.5|||=|0.0016|TWO_SIDED|95.0|3.19|11.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg||11.81|3.19|= 0.0016
71679805|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|2.22|||=|0.3643|TWO_SIDED|95.0|-2.56|7.01||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 5 mg||7.01|-2.56|= 0.3643
71679806|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|2.82|||=|0.2553|TWO_SIDED|95.0|-2.02|7.66||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 10 mg||7.66|-2.02|= 0.2553
71819838|NCT02564055|143142074|OTHER||Difference in percentages|16.8|||||TWO_SIDED|95.0|-9.5|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||41.4|-9.5|
71819839|NCT02564055|143142074|OTHER||Difference in percentages|10.9|||||TWO_SIDED|95.0|-14.9|35.8|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.|||35.8|-14.9|
71819840|NCT02564055|143142074|OTHER||Difference in percentages|33.3|||||TWO_SIDED|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.|||90.6|-31.9|
71819841|NCT02564055|143142074|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.|||47.8|-62.4|
71819842|NCT02564055|143142074|OTHER||Difference in percentages|14.3|||||TWO_SIDED|95.0|-32.2|57.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.|||57.9|-32.2|
71819843|NCT02564055|143142074|OTHER||Difference in percentages|24.2|||||TWO_SIDED|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.|||80.9|-40.3|
71851484|NCT01580306|143217294|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|175.52|STANDARD_DEVIATION|70.4|||TWO_SIDED|90.0|89.55|344.06|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal||344.06|89.55|
71851485|NCT01580306|143217294|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|120.98|STANDARD_DEVIATION|115.0|||TWO_SIDED|90.0|47.257|309.736|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal||309.736|47.257|
71851486|NCT05072795|143217302|OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
71851487|NCT01107912|143217308|NON_INFERIORITY_OR_EQUIVALENCE|The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.|Estimate of the difference|6.0|||||TWO_SIDED|95.0|1.0|9.0||||||||9.00|1.00|
71679807|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|9.69|||=|0.0016|TWO_SIDED|95.0|3.98|15.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg||15.4|3.98|= 0.0016
71679808|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|7.29|||=|0.0128|TWO_SIDED|95.0|1.8|12.79||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg||12.79|1.8|= 0.0128
71679809|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|8.16|||=|0.0051|TWO_SIDED|95.0|2.51|13.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||13.81|2.51|= 0.0051
71819844|NCT02564055|143142081|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-45.8|32.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.|||32.5|-45.8|
71819845|NCT02564055|143142081|OTHER||Difference in percentages|15.4|||||TWO_SIDED|95.0|-25.7|52.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 1 has been presented.|||52.6|-25.7|
71819846|NCT02564055|143142081|OTHER||Difference in percentages|-7.7|||||TWO_SIDED|95.0|-46.0|32.6|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 1 has been presented.|||32.6|-46.0|
71819847|NCT02564055|143142081|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-32.2|48.8|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 1 has been presented.|||48.8|-32.2|
71819848|NCT02564055|143142081|OTHER||Difference in percentages|-24.2|||||TWO_SIDED|95.0|-60.8|14.8|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 2 has been presented.|||14.8|-60.8|
71819849|NCT02564055|143142081|OTHER||Difference in percentages|28.5|||||TWO_SIDED|95.0|-13.7|63.0|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 2 has been presented.|||63.0|-13.7|
71819850|NCT02564055|143142081|OTHER||Difference in percentages|-33.3|||||TWO_SIDED|95.0|-67.4|6.1|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 2 has been presented.|||6.1|-67.4|
71819851|NCT02564055|143142081|OTHER||Difference in percentages|-0.9|||||TWO_SIDED|95.0|-40.7|40.7|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 2 has been presented.|||40.7|-40.7|
71819852|NCT02564055|143142081|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
71819853|NCT02564055|143142081|OTHER||Difference in percentages|43.4|||||TWO_SIDED|95.0|2.7|74.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 4 has been presented.|||74.6|2.7|
71819854|NCT02564055|143142081|OTHER||Difference in percentages|-15.2|||||TWO_SIDED|95.0|-53.8|23.5|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 4 has been presented.|||23.5|-53.8|
71819855|NCT02564055|143142081|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 4 has been presented.|||51.2|-35.6|
71819856|NCT02564055|143142081|OTHER||Difference in percentages|18.3|||||TWO_SIDED|95.0|-25.1|57.1|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 8 has been presented.|||57.1|-25.1|
71819857|NCT02564055|143142081|OTHER||Difference in percentages|47.7|||||TWO_SIDED|95.0|4.8|78.7|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 8 has been presented.|||78.7|4.8|
71819858|NCT02564055|143142081|OTHER||Difference in percentages|-11.7|||||TWO_SIDED|95.0|-51.3|30.2|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 8 has been presented.|||30.2|-51.3|
71679810|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|5.76|||=|0.0389|TWO_SIDED|95.0|0.34|11.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7nights: Zolpidem ER, Lemborexant 10 mg||11.18|0.34|= 0.0389
71679811|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|34.26|||<|0.0001|TWO_SIDED|95.0|26.46|42.06||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 5 mg||42.06|26.46|< 0.0001
71819859|NCT02564055|143142081|OTHER||Difference in percentages|9.1|||||TWO_SIDED|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 8 has been presented.|||51.2|-35.6|
71819860|NCT02564055|143142081|OTHER||Difference in percentages|6.4|||||TWO_SIDED|95.0|-35.4|48.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.|||48.5|-35.4|
71819861|NCT02564055|143142081|OTHER||Difference in percentages|6.0|||||TWO_SIDED|95.0|-35.8|47.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.|||47.1|-35.8|
71819862|NCT02564055|143142081|OTHER||Difference in percentages|-13.6|||||TWO_SIDED|95.0|-54.0|31.2|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.|||31.2|-54.0|
71819863|NCT02564055|143142081|OTHER||Difference in percentages|-25.6|||||TWO_SIDED|95.0|-65.3|22.4|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.|||22.4|-65.3|
71819864|NCT02564055|143142081|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.|||42.7|-44.5|
71819865|NCT02564055|143142081|OTHER||Difference in percentages|5.6|||||TWO_SIDED|95.0|-37.8|47.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.|||47.3|-37.8|
71819866|NCT02564055|143142081|OTHER||Difference in percentages|-5.5|||||TWO_SIDED|95.0|-47.9|37.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.|||37.6|-47.9|
71819867|NCT02564055|143142081|OTHER||Difference in percentages|-4.4|||||TWO_SIDED|95.0|-48.3|41.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.|||41.5|-48.3|
71819868|NCT02564055|143142081|OTHER||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.|||42.7|-44.5|
71819869|NCT02564055|143142081|OTHER||Difference in percentages|8.3|||||TWO_SIDED|95.0|-35.0|49.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.|||49.2|-35.0|
71819870|NCT02564055|143142081|OTHER||Difference in percentages|-3.3|||||TWO_SIDED|95.0|-46.0|42.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.|||42.3|-46.0|
71819871|NCT03268590|143142134|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
71819872|NCT03268590|143142135|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
71819873|NCT03268590|143142136|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
71819874|NCT02971891|143142146|SUPERIORITY|||||||0.1789|||||||Cochran-Mantel-Haenszel|||||||0.1789
71819875|NCT03954158|143142193|SUPERIORITY||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.53||0.0071|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures (MMRM) included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.7|0.0071
71819876|NCT03954158|143142193|SUPERIORITY||Least squares mean of difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0029|TWO_SIDED|95.0|-3.3|-0.8|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.8|-3.3|0.0029
71819877|NCT03954158|143142193|SUPERIORITY||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.025|TWO_SIDED|95.0|-2.7|-0.2|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|0.0250
71819878|NCT03954158|143142193|SUPERIORITY||Least squares mean of difference|-2.1|STANDARD_ERROR_OF_MEAN|0.56||0.0014|TWO_SIDED|95.0|-3.3|-0.9|||Mixed Models Analysis|||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of visit, and the covariance structure UN was used.||-0.9|-3.3|0.0014
71819879|NCT03954158|143142194|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.4295|||TWO_SIDED|95.0|-2.0|0.9||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.9|-2.0|
71819880|NCT03954158|143142194|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4||||||Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.4|-2.1|
71819881|NCT03954158|143142195|OTHER||Least squares mean of difference|-1.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-3.1|-0.7||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.7|-3.1|
71819882|NCT03954158|143142195|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|95.0|-2.7|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.7|
71819883|NCT03954158|143142195|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.2|-0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-2.2|
71819884|NCT03954158|143142195|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-2.8|-0.5||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.5|-2.8|
71679812|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|47.57|||<|0.0001|TWO_SIDED|95.0|40.02|55.13||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 10 mg||55.13|40.02|< 0.0001
71679813|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|4.89|||=|0.2534|TWO_SIDED|95.0|-3.49|13.28||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg||13.28|-3.49|= 0.2534
71851488|NCT01989156|143217349|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.27|17.05||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS Mean Ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarkers of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||17.05|9.27|<0.001
71851489|NCT01989156|143217350|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|45.77|||<|0.001|TWO_SIDED|95.0|39.22|53.41||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||53.41|39.22|<0.001
71851490|NCT01989156|143217351|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|12.58|||<|0.001|TWO_SIDED|95.0|9.54|16.58||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."||16.58|9.54|<0.001
71851491|NCT01989156|143217352|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|26.41|||<|0.001|TWO_SIDED|95.0|17.31|40.26||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||40.26|17.31|<0.001
71902145|NCT01763905|143325952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|1.58|STANDARD_ERROR_OF_MEAN|4.92||0.97|TWO_SIDED|95.0|-8.14|11.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.31|-8.14|0.97
71902146|NCT01763905|143325952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-4.69|STANDARD_ERROR_OF_MEAN|6.25||0.33|TWO_SIDED|95.0|-17.04|7.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||7.67|-17.04|0.33
71902147|NCT01763905|143325953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.15|STANDARD_ERROR_OF_MEAN|2.23||0.068|TWO_SIDED|95.0|0.74|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.56|0.74|0.068
71902148|NCT01763905|143325953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.74|STANDARD_ERROR_OF_MEAN|2.28||0.13|TWO_SIDED|95.0|1.23|10.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||10.24|1.23|0.13
71902149|NCT01763905|143325954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.57|STANDARD_ERROR_OF_MEAN|2.56||0.068|TWO_SIDED|95.0|-1.49|8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.63|-1.49|0.068
71902150|NCT01763905|143325954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.83|STANDARD_ERROR_OF_MEAN|2.52||0.13|TWO_SIDED|95.0|-0.16|9.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||9.81|-0.16|0.13
71679814|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|18.25|||<|0.0001|TWO_SIDED|95.0|10.1|26.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO: Days 1/2: Zolpidem ER, Lemborexant 10 mg||26.4|10.1|< 0.0001
71902151|NCT01763905|143325955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.84|STANDARD_ERROR_OF_MEAN|4.35||0.97|TWO_SIDED|95.0|-10.43|6.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.75|-10.43|0.97
71902152|NCT01763905|143325955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.53|STANDARD_ERROR_OF_MEAN|4.85||0.33|TWO_SIDED|95.0|-13.12|6.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||6.06|-13.12|0.33
71902153|NCT01763905|143325956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.67|STANDARD_ERROR_OF_MEAN|4.7||0.97|TWO_SIDED|95.0|-9.96|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||8.61|-9.96|0.97
71902154|NCT01763905|143325956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|0.08|STANDARD_ERROR_OF_MEAN|5.72||0.33|TWO_SIDED|95.0|-11.24|11.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||||11.39|-11.24|0.33
71902155|NCT01763905|143325957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.9|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-42.26|-31.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-31.55|-42.26|<0.001
71902156|NCT01763905|143325957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.69|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-43.06|-34.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.||-34.22|-43.06|<0.001
71679815|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|22.2|||<|0.0001|TWO_SIDED|95.0|14.06|30.35||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 5 mg||30.35|14.06|< 0.0001
71679816|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|24.13|||<|0.0001|TWO_SIDED|95.0|16.16|32.1||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 10 mg||32.1|16.16|< 0.0001
71679817|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|9.59|||=|0.023|TWO_SIDED|95.0|1.36|17.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg||17.81|1.36|= 0.023
71902157|NCT04346628|143325958|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.24|TWO_SIDED|95.0|0.48|1.2||The final test was performed at the alpha = 0.04999 level of significance, adjusted for age group and sex.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|||1.20|0.48|0.24
71902158|NCT04346628|143325960|SUPERIORITY|||||||0.06||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in hospitalizations||||0.06
71902159|NCT04346628|143325960|SUPERIORITY|||||||0.56||||||A p-value of 0.05 would have been considered statistically significant.|Fisher Exact|||Difference in ED visits||||0.56
71679818|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|11.43|||=|0.0058|TWO_SIDED|95.0|3.38|19.48||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg||19.48|3.38|= 0.0058
71679819|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|7.3|||=|0.0222|TWO_SIDED|95.0|1.27|13.33||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 5||13.33|1.27|= 0.0222
71851492|NCT01989156|143217353|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|38.14|||<|0.001|TWO_SIDED|95.0|34.24|42.47||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."||42.47|34.24|<0.001
71679820|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|10.84|||=|0.0013|TWO_SIDED|95.0|4.57|17.11||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg||17.11|4.57|= 0.0013
71851493|NCT00850993|143217354|OTHER|Pairwise comparison for each Stannsoporfin treatment group versus placebo.|LS Mean Difference|-13.45|||=|0.04|TWO_SIDED|95.0|-26.27|-0.62|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Least-squares means are from an ANCOVA model for adjusted TSB with treatment and gestational age as fixed effects and baseline adjusted TSB as a covariate. TSB is calculated as \[(TSB - Phototherapy(PT) threshold)/ PT threshold \] X 100%.||-0.62|-26.27|=0.040
71851494|NCT00850993|143217354|OTHER||LS Mean Difference|-10.02|||=|0.117|TWO_SIDED|95.0|-22.61|2.58|||ANCOVA|||||2.58|-22.61|=0.117
71851495|NCT00850993|143217354|OTHER||LS Mean Difference|-14.93|||=|0.057|TWO_SIDED|95.0|-30.31|0.44|||ANCOVA|||||0.44|-30.31|=0.057
71851496|NCT00850993|143217355|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.81|||=|0.061|TWO_SIDED|95.0|-3.71|0.09|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.09|-3.71|=0.061
71851497|NCT00850993|143217355|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.34|||=|0.163|TWO_SIDED|95.0|-3.24|0.56|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||0.56|-3.24|=0.163
71851498|NCT00850993|143217355|OTHER|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-2.63|||=|0.028|TWO_SIDED|95.0|-4.97|-0.3|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.||-0.3|-4.97|=0.028
71851499|NCT01721109|143217406|EQUIVALENCE|A sample size of 14 participants was estimated to provide over 95% power to show pharmacokinetic equivalence between adult and adolescent participants. EVG population PK from historical adult data was used for comparison. The inter-subject standard deviation (natural log scale) of EVG AUCtau observed in the population PK data was 0.31 (historical data).|Geometric least squares mean ratio|1.3029|||||TWO_SIDED|90.0|1.0479|1.62||||||||1.6200|1.0479|
71851500|NCT01426217|143217455|OTHER|Efficacy|Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.63|0.98||||||||0.98|0.63|
71851501|NCT01426217|143217456|OTHER|Efficacy|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.62|1.35||||||||1.35|0.62|
71851502|NCT02991456|143217517|OTHER|||||||0.2734|||||||Chi-squared|||||||0.2734
71851503|NCT02991456|143217518|OTHER|||||||0.7091|||||||Chi-squared|||||||0.7091
71851504|NCT02991456|143217519|EQUIVALENCE|This was tested as patients who preferred rolapitant + ondansetron vs. patients who did not prefer rolapitant + ondansetron. Patients who reported no preference and preference to Ondansetron were combined.||||||0.0004|||||||Exact Binomial|||||||0.0004
71851505|NCT02991456|143217519|EQUIVALENCE|Three outcomes tested by sequence.||||||0.5207|||||||Fisher Exact|||||||0.5207
71851506|NCT02991456|143217520|EQUIVALENCE|Effectiveness during weeks 1-3 between sequences.||||||0.0406|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.0406
71851507|NCT02991456|143217521|EQUIVALENCE|Convenience during weeks 1-3 between sequences.||||||0.0541|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0541
71851508|NCT02991456|143217522|EQUIVALENCE|Overall satisfaction during weeks 1-3 between sequences.||||||0.0781|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.0781
71851509|NCT02991456|143217523|EQUIVALENCE|Effectiveness during weeks 4-6 between sequences.||||||0.4146|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.4146
71851510|NCT02991456|143217524|EQUIVALENCE|Convenience during weeks 4-6 between sequences.||||||0.2214|||||||t-test, 1 sided|T-test using the pooled method for equal variances.||||||0.2214
71851511|NCT02991456|143217525|EQUIVALENCE|Overall satisfaction during weeks 4-6 between sequences.||||||0.2028|||||||t-test, 1 sided|T-test using the Satterthwaite method for unequal variances.||||||0.2028
71851512|NCT02066389|143217555|SUPERIORITY|||||||0.153||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.153
71851513|NCT02066389|143217555|SUPERIORITY|||||||0.018||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.018
71851514|NCT02066389|143217555|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
71851515|NCT02066389|143217555|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
71851516|NCT02066389|143217555|SUPERIORITY|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.001
71819885|NCT03954158|143142195|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|95.0|-1.5|1.3||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.3|-1.5|
71819886|NCT03954158|143142195|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-1.2|1.0||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||1.0|-1.2|
71819887|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.9|-0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.1|-0.9|
71819888|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-0.9|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.9|
71819889|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|95.0|-0.8|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.1|-0.8|
71819890|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.8|0.0||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-0.8|
71819891|NCT03954158|143142196|OTHER||Difference of least square mean|0.1|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.4|0.6||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.4|
71819892|NCT03954158|143142196|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.3|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.7|-0.3|
71819893|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|95.0|-1.4|-0.4||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.4|-1.4|
71851517|NCT02066389|143217556|SUPERIORITY|||||||0.034||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.034
71851518|NCT02066389|143217556|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
71902160|NCT04346628|143325962|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.43|TWO_SIDED|95.0|0.54|1.29||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until initial resolution of symptoms||1.29|0.54|0.43
71819894|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
71819895|NCT03954158|143142196|OTHER||Least squares mean of difference|-0.7|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|95.0|-1.2|-0.2||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.2|-1.2|
71819896|NCT03954158|143142196|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.21|||TWO_SIDED|95.0|-1.4|-0.6||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||-0.6|-1.4|
71819897|NCT03954158|143142196|OTHER||Difference of least square mean|0.0|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-0.5|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.6|-0.5|
71819898|NCT03954158|143142196|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, visit, dosing regimen-by-visit interaction, and baseline value and the covariance structure UN was used.||0.5|-0.7|
71819899|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-1.0|-0.2||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.2|-1.0|
71819900|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.7|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.5|-0.7|
71819901|NCT03954158|143142197|OTHER||Difference of least squares mean|0.6|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.5|1.7||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.7|-0.5|
71819902|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
71819903|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.9|0.4||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-0.9|
71851519|NCT02066389|143217556|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.002
71851520|NCT02066389|143217556|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.010
71851521|NCT02066389|143217556|SUPERIORITY|||||||0.012||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.012
71851522|NCT02066389|143217557|SUPERIORITY|||||||0.023||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.023
71679821|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|0.21|||=|0.9495|TWO_SIDED|95.0|-6.17|6.58||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg||6.58|-6.17|= 0.9495
71819904|NCT03954158|143142197|OTHER||Difference of least square mean|0.2|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|-0.9|1.3||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.9|
71819905|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.1|-0.5||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.1|
71819906|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
71819907|NCT03954158|143142197|OTHER||Difference of least square mean|0.4|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.6|1.4||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.4|-0.6|
71819908|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.9|-0.3||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.9|
71819909|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.5|-0.1||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.5|
71819910|NCT03954158|143142197|OTHER||Difference of least square mean|-0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.1|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.0|-1.1|
71819911|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.1|-0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.4|-2.1|
71819912|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.1|0.4||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.4|-1.1|
71851523|NCT02066389|143217557|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
71851524|NCT02066389|143217557|SUPERIORITY|||||||0.145||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.145
71819913|NCT03954158|143142197|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-0.6|1.5||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.5|-0.6|
71819914|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.3|
71819915|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.2|-1.0|
71819916|NCT03954158|143142197|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.6|1.3||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.3|-0.6|
71819917|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.0|-0.3||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-2.0|
71819918|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.3|0.1||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.1|-1.3|
71819919|NCT03954158|143142197|OTHER||Difference of least square mean|0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.6|1.2||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.2|-0.6|
71819920|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.7|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-2.4|-0.9||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.4|
71819921|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.7|-1.5|
71819922|NCT03954158|143142197|OTHER||Difference of least square mean|0.5|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-0.7|1.6||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||1.6|-0.7|
71851525|NCT02066389|143217557|SUPERIORITY|||||||0.007||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.007
71851526|NCT02066389|143217557|SUPERIORITY|||||||0.014||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.014
71851527|NCT02066389|143217558|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.005
71851528|NCT02066389|143217558|SUPERIORITY||||||<|0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||<0.001
71679822|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|3.72|||=|0.2708|TWO_SIDED|95.0|-2.88|10.32||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO: First 7 nights: Zolpidem ER, Lemborexant 10 mg||10.32|-2.88|= 0.2708
71851529|NCT02066389|143217558|SUPERIORITY|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.010
71851530|NCT02066389|143217558|SUPERIORITY|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.002
71851531|NCT02066389|143217558|SUPERIORITY|||||||0.024||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact|||||||0.024
71851532|NCT02066389|143217559|SUPERIORITY|||||||0.015||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.015
71851533|NCT02066389|143217559|SUPERIORITY|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.008
71851534|NCT02066389|143217559|SUPERIORITY|||||||0.029||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.029
71851535|NCT02066389|143217559|SUPERIORITY|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.003
71851536|NCT02066389|143217559|SUPERIORITY|||||||0.343||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.343
71851537|NCT02066389|143217560|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
71851538|NCT02066389|143217560|SUPERIORITY|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.039
71851539|NCT02066389|143217560|SUPERIORITY|||||||0.046||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.046
71851540|NCT02066389|143217560|SUPERIORITY|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.005
71851541|NCT02066389|143217560|SUPERIORITY|||||||0.096||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.096
71851542|NCT02066389|143217561|SUPERIORITY|||||||0.269||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.269
71851543|NCT02066389|143217561|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
71851544|NCT02066389|143217561|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
71851545|NCT02066389|143217561|SUPERIORITY|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||0.160
71851546|NCT02066389|143217561|SUPERIORITY|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared|||||||1.000
71679823|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|7.91|||=|0.0322|TWO_SIDED|95.0|0.86|14.96||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg||14.96|0.86|= 0.0322
71851547|NCT02907489|143217562|SUPERIORITY|||||||0.083||||||0.083 for 24 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.083
71851548|NCT02907489|143217562|SUPERIORITY|||||||0.041||||||0.041 for 48 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.041
71851549|NCT02907489|143217562|SUPERIORITY|||||||0.063||||||0.063 for 72 hours, Significant at P ≤ 0.05|Chi-squared|||||||0.063
71851550|NCT02907489|143217563|SUPERIORITY|||||||0.982||||||0.982 for S1, Significant at P ≤ 0.05|Chi-squared|||||||0.982
71851551|NCT02907489|143217563|SUPERIORITY|||||||0.467||||||0.467 for S2, Significant at P ≤ 0.05|Chi-squared|||||||0.467
71851552|NCT02907489|143217563|SUPERIORITY|||||||0.01||||||0.01 for S3 Significant at P ≤ 0.05|Chi-squared|||||||0.01
71851553|NCT00762853|143217564|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71851554|NCT01755598|143217565|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, is to be above 0%.|Vaccine efficacy rate|49.7||||0.043|TWO_SIDED|90.0|12.1|71.2|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, as compared to placebo.||71.2|12.1|0.0430
71851555|NCT01755598|143217566|OTHER|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. If the primary objective is met, this secondary objective is to be analysed using the following success criterion: The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV infection, meeting the case definition 2, is to be above 0%.|Vaccine efficacy rate|61.67||||0.021|TWO_SIDED|90.0|24.084|80.647|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite Xpert MTB/Rif positive pulmonary TB disease not associated with HIV-infection, meeting the case definition 2, as compared to placebo.||80.647|24.084|0.0210
71851556|NCT02924051|143217585|EQUIVALENCE|With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.|Mean Difference (Final Values)|1.12||||0.26|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.26
71851557|NCT02924051|143217587|SUPERIORITY|||||||0.36|||||||t-test, 1 sided|||Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.||||0.36
71851558|NCT00828178|143217588|SUPERIORITY_OR_OTHER|||||||0.87|||||||t-test, 2 sided|||Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.||||0.87
71851559|NCT00828178|143217589|SUPERIORITY_OR_OTHER|||||||0.1801||||||This Statistical Analysis applies category SELENA-SLEDAI|t-test, 2 sided|||||||0.1801
71819923|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-2.3|-0.9||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.9|-2.3|
71819924|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.1|
71819925|NCT03954158|143142197|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 10, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.8|
71851560|NCT00738400|143217622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|||<|0.0001||95.0|-9.03|-4.49|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-4.49|-9.03|<0.0001
71851561|NCT00738400|143217623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.71|||<|0.0001||95.0|-30.66|-10.76|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-10.76|-30.66|<0.0001
71851562|NCT00738400|143217624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.16|||<|0.0001||95.0|-37.48|-14.83|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-14.83|-37.48|<0.0001
71851563|NCT00738400|143217625|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mantel Haenszel|||Mantel-Haenszel Test||||0.0004
71679824|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|7.69|||=|0.0363|TWO_SIDED|95.0|0.68|14.71||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg||14.71|0.68|= 0.0363
71679825|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|0.05|||=|0.9885|TWO_SIDED|95.0|-7.14|7.24||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg||7.24|-7.14|= 0.9885
71679826|NCT02783729|142877149|SUPERIORITY||Difference of Percentage|-0.16|||=|0.9651|TWO_SIDED|95.0|-7.31|6.99||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg||6.99|-7.31|= 0.9651
71819926|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.7|0.0||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-1.7|
71819927|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-2.3|-0.7||||||Change at Day 11, Intra-participant: MMRM included the fixed effect of day, and the covariance structure UN was used.||-0.7|-2.3|
71902161|NCT04346628|143325962|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45||A p-value of 0.05 would have been considered statistically significant.|Cox proportional hazards model||Hazard ratio adjusted for age and sex|Difference in days until sustained resolution of symptoms||1.45|0.52|0.59
71902162|NCT00850759|143325976|SUPERIORITY_OR_OTHER||Slope|0.04|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71902163|NCT00300469|143326003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71902164|NCT00300469|143326003|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%||||<0.001
71902165|NCT00300469|143326004|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.005
71819928|NCT03954158|143142197|OTHER||Difference of Least Squares Mean|0.2|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.7|1.1||||||Change at Day 11, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.1|-0.7|
71819929|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.0|-0.5||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-2.0|
71851564|NCT00738400|143217626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.57||||0.0003||95.0|-23.8|-7.34|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-7.34|-23.80|0.0003
71851565|NCT00738400|143217627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.33|||<|0.0001||95.0|-37.24|-17.43|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint||-17.43|-37.24|<0.0001
71851566|NCT02009865|143217630|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-14.2||||0.017|TWO_SIDED|95.0|-26.2|-2.8|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-26.2|0.017
71851567|NCT02009865|143217631|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.3||||0.0008|TWO_SIDED|95.0|-40.5|-11.5|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Main analysis with missing values imputed using probabilities of missing estimated from logistic regression||-11.5|-40.5|0.0008
71679827|NCT02783729|142877150|SUPERIORITY||LSM Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.319|=|0.0006|TWO_SIDED|95.0|-1.73|-0.47||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||-0.47|-1.73|= 0.0006
71819930|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||0.0|-2.0|
71819931|NCT03954158|143142197|OTHER||Difference of Least Squares Mean|0.1|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.9|1.2||||||Change at Day 12, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||1.2|-0.9|
71819932|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-1.8|-0.3||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.3|-1.8|
71819933|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.0|-0.1||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-2.0|
71819934|NCT03954158|143142197|OTHER||Difference of Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.3|0.9||||||Change at Day 13, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.9|-1.3|
71819935|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-1.9|-0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.5|-1.9|
71851568|NCT02009865|143217632|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-9.0||||0.018|TWO_SIDED|95.0|-14.8|-2.8||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||-2.8|-14.8|0.0180
71851569|NCT02009865|143217633|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.3||||0.7117|TWO_SIDED|95.0|-3.5|4.9||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||4.9|-3.5|0.7117
71851570|NCT02009865|143217634|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-10.3||||0.3034|TWO_SIDED|95.0|-23.9|3.5||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression||3.5|-23.9|0.3034
71851571|NCT03677986|143217653|SUPERIORITY||Odds Ratio (OR)|0.92||||0.914|TWO_SIDED|95.0|0.21|4.14|||GEE|||||4.14|.21|0.914
71851572|NCT00424502|143217656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.017|STANDARD_DEVIATION|1.34|<|0.0001|TWO_SIDED|95.0|1.39|2.64|||t-test, 2 sided|||Change from Baseline to Week 24||2.64|1.39|<0.0001
71851573|NCT00424502|143217657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_DEVIATION|0.259|<|0.0001|TWO_SIDED|95.0|0.151|0.401|||t-test, 2 sided|||Change from baseline to Week 24||0.401|0.151|<0.0001
71851574|NCT00424502|143217660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.4|STANDARD_DEVIATION|23.24||0.012|TWO_SIDED|95.0|3.52|25.28|||t-test, 2 sided|||Change from baseline to Week 24||25.28|3.52|0.012
71851575|NCT00424502|143217661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_DEVIATION|8.21||0.337|TWO_SIDED|95.0|-2.03|5.65|||t-test, 2 sided|||Change from baseline to Week 24||5.65|-2.03|0.337
71819936|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.8|-0.1||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.1|-1.8|
71819937|NCT03954158|143142197|OTHER||Difference of Least Squares Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.5|0.7||||||Change at Day 14, Inter-participant: Mixed effect Model for Repeated Measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value, and the covariance structure UN was used.||0.7|-1.5|
71819938|NCT03954158|143142197|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-2.2|-0.8||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of day, and the covariance structure UN was used.||-0.8|-2.2|
71819939|NCT03954158|143142197|OTHER||Least squares mean of difference|-0.8|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.5|0.0||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures included the fixed effect of visit, and the covariance structure UN was used.||0.0|-1.5|
71819940|NCT03954158|143142197|OTHER||Difference of least square mean|-0.3|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.4|0.8||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen, day, dosing regimen-by-day interaction, and baseline value and the covariance structure UN was used.||0.8|-1.4|
71819941|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|95.0|-1.0|0.2||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.2|-1.0|
71819942|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 2, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
71851576|NCT05356130|143217664|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||"We conducted the same two independent planned comparisons: Enhanced BLT Encouragement + Adherence Promotion compared to Minimal BLT Encouragement; Minimal BLT Encouragement and Enhanced BLT Encouragement + Adherence Promotion compared to TAU."||||0.014
71851577|NCT03141177|143217665|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.64|||Stratified Log-Rank|||||0.64|0.41|<0.0001
71851578|NCT03141177|143217666|SUPERIORITY|Treatment A over Treatment C|Hazard Ratio (HR)|0.6||||0.001|TWO_SIDED|98.89|0.4|0.89|||Stratified Log-Rank|||||0.89|0.40|0.0010
71679828|NCT02783729|142877150|SUPERIORITY||LSM Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.32|=|0.0007|TWO_SIDED|95.0|-1.71|-0.46||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||-0.46|-1.71|= 0.0007
71819943|NCT03954158|143142198|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.5|1.1||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.1|-0.5|
71819944|NCT03954158|143142198|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|95.0|-0.6|0.7||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.6|
71819945|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 3, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
71819946|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
71819947|NCT03954158|143142198|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|96.0|-1.1|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.1|
71819948|NCT03954158|143142198|OTHER||Least squares mean of difference|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8||||||Change at Day 4, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.8|-0.8|
71851579|NCT03141177|143217667|SUPERIORITY|Treatment A over Treatment C|Odds Ratio (OR)|3.52|||<|0.0001|TWO_SIDED|95.0|2.51|4.95|||Stratified Cochran-Mantel-Haenszel|||||4.95|2.51|<0.0001
71819949|NCT03954158|143142198|OTHER||Difference of least squares mean|0.0|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-0.9|0.8||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.9|
71819950|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.2|0.3||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.2|
71819951|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 5, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
71819952|NCT03954158|143142198|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|1.0||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.8|
71819953|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
71819954|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 6, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-0.9|
71819955|NCT03954158|143142198|OTHER||Difference of least squares mean|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
71819956|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.0|0.9||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.9|-1.0|
71819957|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.7||||||Change at Day 7, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.7|-1.0|
71819958|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.2|
71819959|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.3|0.5||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.3|
71819960|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.4|0.2||||||Change at Day 8, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.4|
71819961|NCT03954158|143142198|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.5|0.8||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-0.5|
71819962|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.6||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.6|-1.2|
71819963|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.4||||||Change at Day 9, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.4|-1.2|
71819964|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-1.2|0.1||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.1|-1.2|
71819965|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.3|0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-1.3|
71851580|NCT03141177|143217667|OTHER|Treatment A - Treatment C|Difference of Objective Response Rates|28.6|||||TWO_SIDED|95.0|21.7|35.6|||||Strata adjusted difference in objective response rate (Nivolumab+Cabozantinib - Sunitinib) based on DerSimonian and Laird.|||35.6|21.7|
71679829|NCT02783729|142877150|SUPERIORITY||LSM Difference|0.32|STANDARD_ERROR_OF_MEAN|0.301|=|0.2951|TWO_SIDED|95.0|-0.28|0.91||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||0.91|-0.28|= 0.2951
71679830|NCT02783729|142877150|SUPERIORITY||LSM Difference|0.33|STANDARD_ERROR_OF_MEAN|0.303|=|0.2744|TWO_SIDED|95.0|-0.26|0.92||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||0.92|-0.26|= 0.2744
71679831|NCT02783729|142877151|SUPERIORITY||LSM Difference|-1.26|STANDARD_ERROR_OF_MEAN|1.063|=|0.2348|TWO_SIDED|95.0|-3.35|0.82||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg||0.82|-3.35|= 0.2348
71679832|NCT02783729|142877151|SUPERIORITY||LSM Difference|-1.17|STANDARD_ERROR_OF_MEAN|1.067|=|0.2745|TWO_SIDED|95.0|-3.26|0.93||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg||0.93|-3.26|= 0.2745
71679833|NCT02783729|142877151|SUPERIORITY||LSM Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.005|=|0.711|TWO_SIDED|95.0|-2.35|1.6||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg||1.6|-2.35|= 0.711
71819966|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 10, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.6|-1.0|
71819967|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.1|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|95.0|-0.8|0.5||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-0.8|
71819968|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.6|0.3||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-1.6|
71819969|NCT03954158|143142198|OTHER||Difference of least squares mean|0.3|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.4|1.0||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.0|-0.4|
71819970|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 11, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
71819971|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|95.0|-1.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-1.9|
71819972|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 12, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
71851581|NCT02680314|143217675|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
71851582|NCT05361304|143217713|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.04|0.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under HLLC.||0.000|-0.040|
71851583|NCT05361304|143217713|NON_INFERIORITY||Least square Mean (LSM) Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.012|||TWO_SIDED|95.0|-0.03|0.02|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology for distance (4m) under LLHC.||0.020|-0.030|
71851584|NCT05361304|143217714|NON_INFERIORITY||Least square Mean (LSM) Difference|0.27|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.46|1.01|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|It was calculated using a 2 independent sample means t-test with a 2-sided type I error rate of 5% with at least 80% statistical power, that 100 subjects were required to test for non-inferiority of the Senofilcon A contact lenses made with a novel manufacturing technology compared to the Senofilcon A contact lenses made with the current manufacturing technology.||1.010|-0.460|
71851585|NCT05361304|143217715|NON_INFERIORITY||LSM Difference|4.0|STANDARD_ERROR_OF_MEAN|4.06|||TWO_SIDED|95.0|-4.1|12.0|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||12.0|-4.1|
71851586|NCT05361304|143217716|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the confidence interval of the mean difference between Senofilcon A contact lenses made with a novel manufacturing technology and Senofilcon A contact lenses made with the current manufacturing technology is greater than -5.|LSM Differences|-0.3|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.1|6.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|LSM difference was calculated as Senofilcon A contact lenses made with a novel manufacturing technology minus Senofilcon A contact lenses made with the current manufacturing technology|||6.5|-7.1|
71851587|NCT01877720|143217726|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||||||<0.001
71851588|NCT01877720|143217727|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Paired t-test|||||||0.001
71851589|NCT01877720|143217728|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED||||||Paired t-test|||||||0.74
71851590|NCT01877720|143217729|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
71851591|NCT01877720|143217730|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Paired t-test|||||||0.002
71902166|NCT00300469|143326004|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%||||0.010
71902167|NCT00300469|143326005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71679834|NCT02783729|142877151|SUPERIORITY||LSM Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.009|=|0.7854|TWO_SIDED|95.0|-2.26|1.71||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg||1.71|-2.26|= 0.7854
71679835|NCT02783729|142877152|SUPERIORITY||LSM Difference|30.77|STANDARD_ERROR_OF_MEAN|12.505|=|0.0141|TWO_SIDED|95.0|6.23|55.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 5 mg||55.31|6.23|= 0.0141
71679836|NCT02783729|142877152|SUPERIORITY||LSM Difference|39.67|STANDARD_ERROR_OF_MEAN|12.542|=|0.0016|TWO_SIDED|95.0|15.05|64.29||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 10 mg||64.29|15.05|= 0.0016
71851592|NCT01877720|143217731|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Paired t-test|||||||0.003
71851593|NCT01877720|143217732|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Paired t-test|||||||0.012
71851594|NCT01877720|143217733|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Paired t-test|||||||0.67
71851595|NCT01877720|143217734|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
71851596|NCT01877720|143217735|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon signed-rank test|||||||<0.001
71679837|NCT02783729|142877152|SUPERIORITY||LSM Difference|-19.22|STANDARD_ERROR_OF_MEAN|11.779|=|0.1031|TWO_SIDED|95.0|-42.34|3.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 5 mg||3.9|-42.34|= 0.1031
71851597|NCT02068352|143217749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|11.93||||0.069|TWO_SIDED|95.0|-0.08|23.95||P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||23.95|-0.08|0.0690
71819973|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-1.0|0.5||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.0|
71679838|NCT02783729|142877152|SUPERIORITY||LSM Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.813|=|0.3825|TWO_SIDED|95.0|-33.5|12.86||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 10 mg||12.86|-33.5|= 0.3825
71819974|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.5|0.4||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.5|
71819975|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.5|0.2||||||Change at Day 13, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.2|-1.5|
71819976|NCT03954158|143142198|OTHER||Least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.1|0.3||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.3|-1.1|
71819977|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-1.4|0.4||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.4|-1.4|
71819978|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.1|0.5||||||Change at Day 14, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.1|
71819979|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
71819980|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
71851598|NCT02068352|143217749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|18.23||||0.0165|TWO_SIDED|95.0|4.99|31.46||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||31.46|4.99|0.0165
71902168|NCT00300469|143326005|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide \>99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%||||<0.001
71679839|NCT02783729|142877152|SUPERIORITY||LSM Difference|28.81|STANDARD_ERROR_OF_MEAN|60.626|=|0.6348|TWO_SIDED|95.0|-90.18|147.8||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 5 mg||147.8|-90.18|= 0.6348
71819981|NCT03954158|143142198|OTHER||Least squares mean of difference|-0.4|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.2|0.5||||||Change at Day 15, Intra-participant: Mixed effect model for repeated measures includes the fixed effect of day and the covariance structure AR1 is used.||0.5|-1.2|
71819982|NCT03954158|143142198|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-1.0|0.6||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.0|
71819983|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-0.9|0.7||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.7|-0.9|
71819984|NCT03954158|143142199|OTHER||Least squares mean of difference|0.2|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-0.6|1.0||||||Change at Day 2, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-0.6|
71819985|NCT03954158|143142199|OTHER||Difference of least squares mean|0.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.8|1.2||||||Change at Day 2, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-0.8|
71819986|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.9|0.5||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-0.9|
71819987|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-1.5|1.0||||||Change at Day 3, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.0|-1.5|
71851599|NCT02068352|143217749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|12.3||||0.0617|TWO_SIDED|95.0|0.06|24.53||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||24.53|0.06|0.0617
71851600|NCT02068352|143217750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47||||0.0128|TWO_SIDED|95.0|-0.84|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, and interaction of treatment by visit as terms, Baseline score as a covariate.||||-0.10|-0.84|0.0128
71851601|NCT02068352|143217750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46||||0.0134|TWO_SIDED|95.0|-0.81|-0.1|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.10|-0.81|0.0134
71851602|NCT02068352|143217751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0048|TWO_SIDED|95.0|-0.85|-0.16|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.85|0.0048
71679840|NCT02783729|142877152|SUPERIORITY||LSM Difference|50.83|STANDARD_ERROR_OF_MEAN|60.702|=|0.4026|TWO_SIDED|95.0|-68.3|169.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 10 mg||169.97|-68.3|= 0.4026
71819988|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.6|0.5||||||Change at Day 3, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-1.6|
71819989|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-1.1|0.8||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.8|-1.1|
71819990|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.5|1.1||||||Change at Day 4, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.1|-1.5|
71819991|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.9|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|95.0|-2.4|0.6||||||Change at Day 4, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-2.4|
71819992|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.4|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|95.0|-2.2|-0.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.5|-2.2|
71851603|NCT02068352|143217751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0045|TWO_SIDED|95.0|-0.84|-0.16|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.16|-0.84|0.0045
71851604|NCT02068352|143217753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.26||||0.4173|TWO_SIDED|95.0|-8.99|21.52||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||21.52|-8.99|0.4173
71902169|NCT00578864|143326023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||95.0|||||Fisher Exact|||||||0.367
71902170|NCT00578864|143326026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.592||95.0|||||Fisher Exact|||||||0.592
71902171|NCT00436969|143326035|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.472||||0.696|TWO_SIDED|95.0|-8.888|5.943||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||5.943|-8.888|0.696
71819993|NCT03954158|143142199|OTHER||Least squares mean of difference|0.1|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-1.3|1.5||||||Change at Day 5, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||1.5|-1.3|
71902172|NCT00436969|143326036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-15.6|15.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||15.1|-15.6|
71902173|NCT00436969|143326037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-19.7|9.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.||9.1|-19.7|
71902174|NCT00436969|143326038|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.87||||0.827|TWO_SIDED|95.0|-8.698|6.957||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.957|-8.698|0.827
71851605|NCT02068352|143217753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.47||||0.4895|TWO_SIDED|95.0|-9.43|20.36||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||20.36|-9.43|0.4895
71851606|NCT02068352|143217753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.19||||0.2677|TWO_SIDED|95.0|-6.74|25.12||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.12|-6.74|0.2677
71851607|NCT02068352|143217753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.12||||0.2319|TWO_SIDED|95.0|-5.63|25.87||P-value was derived using CMH test stratified by age group (\< 18 or ≥ 18) and region.|Cochran-Mantel-Haenszel|||||25.87|-5.63|0.2319
71851608|NCT02068352|143217754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.11||||0.3213|TWO_SIDED|95.0|-3.33|1.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.11|-3.33|0.3213
71851609|NCT02068352|143217754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.09||||0.0594|TWO_SIDED|95.0|-4.27|0.08|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.08|-4.27|0.0594
71819994|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.2|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-1.7|1.2||||||Change at Day 5, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||1.2|-1.7|
71851610|NCT02068352|143217754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.03||||0.396|TWO_SIDED|95.0|-3.43|1.37|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||1.37|-3.43|0.396
71851611|NCT02068352|143217754|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.1135|TWO_SIDED|95.0|-4.26|0.46|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.46|-4.26|0.1135
71851612|NCT02068352|143217755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||0.1703|TWO_SIDED|95.0|-3.63|0.65|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.65|-3.63|0.1703
71851613|NCT02068352|143217755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56||||0.0176|TWO_SIDED|95.0|-4.67|-0.45|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.45|-4.67|0.0176
71851614|NCT02068352|143217755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.41||||0.2381|TWO_SIDED|95.0|-3.78|0.95|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||0.95|-3.78|0.2381
71851615|NCT02068352|143217755|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.36||||0.047|TWO_SIDED|95.0|-4.68|-0.03|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.03|-4.68|0.047
71851616|NCT02068352|143217756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.8196|TWO_SIDED|95.0|-13.5|10.7|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||10.7|-13.5|0.8196
71851617|NCT02068352|143217756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.83||||0.0503|TWO_SIDED|95.0|-23.69|0.02|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||0.02|-23.69|0.0503
71851618|NCT02068352|143217756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.68||||0.5902|TWO_SIDED|95.0|-17.22|9.85|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||9.85|-17.22|0.5902
71851619|NCT02068352|143217756|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.42||||0.0482|TWO_SIDED|95.0|-26.73|-0.11|||Mixed Models Analysis|MMRM with fixed effects of treatment, region, visit, age group, interaction of treatment by visit, Baseline score as a covariate.||||-0.11|-26.73|0.0482
71851620|NCT02068352|143217757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.8633|TWO_SIDED|95.0|-12.48|10.48|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.48|-12.48|0.8633
71851621|NCT02068352|143217757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.54||||0.0452|TWO_SIDED|95.0|-22.83|-0.25|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.25|-22.83|0.0452
71851622|NCT02068352|143217757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73||||0.6746|TWO_SIDED|95.0|-15.58|10.12|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||10.12|-15.58|0.6746
71851623|NCT02068352|143217757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.05||||0.0432|TWO_SIDED|95.0|-25.69|-0.4|||ANCOVA|ANCOVA model with treatment, region, age group as terms, and Baseline score as a covariate for change from Baseline.||||-0.4|-25.69|0.0432
71851624|NCT00267956|143217788|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The study is designed to maintain a Type I error of 0.05 or less for the primary analysis|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by subject's prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.||||<0.001
71851625|NCT00267956|143217789|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between Group II and Group I at a significant level of 0.05.||||0.004
71851626|NCT00267956|143217790|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||0.005
71819995|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
71819996|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-1.4|0.5||||||Change at Day 6, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.5|-1.4|
71819997|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.4|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-1.7|0.8||||||Change at Day 6, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.8|-1.7|
71819998|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-2.0|-0.2||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.0|
71819999|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-2.1|-0.1||||||Change at Day 7, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.1|
71902175|NCT00436969|143326039|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.875||||0.392|TWO_SIDED|95.0|-9.472|3.723||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.723|-9.472|0.392
71820000|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.6||||||Change at Day 7, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.6|-1.9|
71820001|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-2.0|0.0||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.0|
71820002|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-2.4|-0.2||||||Change at Day 8, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.2|-2.4|
71820003|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.6|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.9|0.7||||||Change at Day 8, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.7|-1.9|
71820004|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.3|-0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.3|
71820005|NCT03954158|143142199|OTHER||Least squares mean of difference|-0.9|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.9|0.1||||||Change at Day 9, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-1.9|
71820006|NCT03954158|143142199|OTHER||Difference of least squares mean|-1.1|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.4|0.2||||||Change at Day 9, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.2|-2.4|
71820007|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
71820008|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.7||||||Change at Day 10, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.5|
71820009|NCT03954158|143142199|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.6|-0.2||||||Change at Day 10, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.2|-2.6|
71820010|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
71820011|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.2|-0.1||||||Change at Day 11, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.2|
71820012|NCT03954158|143142199|OTHER||Difference of least squares mean|-0.8|STANDARD_ERROR_OF_MEAN|0.67|||TWO_SIDED|95.0|-2.2|0.5||||||Change at Day 11, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||0.5|-2.2|
71820013|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-2.9|0.0||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.0|-2.9|
71820014|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-2.4|-0.7||||||Change at Day 12, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.7|-2.4|
71820015|NCT03954158|143142199|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.9|-0.3||||||Change at Day 12, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.3|-2.9|
71820016|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.1|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-2.5|0.3||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.3|-2.5|
71902176|NCT00436969|143326040|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.932||||0.772|TWO_SIDED|95.0|-7.26|5.396||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.396|-7.260|0.772
71679841|NCT02783729|142877152|SUPERIORITY||LSM Difference|-203.36|STANDARD_ERROR_OF_MEAN|57.171|=|0.0004|TWO_SIDED|95.0|-315.56|-91.15||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 5 mg||-91.15|-315.56|= 0.0004
71820017|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.5|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-2.4|-0.6||||||Change at Day 13, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.4|
71820018|NCT03954158|143142199|OTHER||Difference of least squares mean|-1.7|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-3.0|-0.5||||||Change at Day 13, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.5|-3.0|
71820019|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.6|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-2.5|-0.6||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.6|-2.5|
71820020|NCT03954158|143142199|OTHER||Difference of least squares mean|-1.6|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.8|-0.4||||||Change at Day 14, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.4|-2.8|
71820021|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-2.5|0.1||||||Change at Day 14, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||0.1|-2.5|
71820022|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.4|-0.1||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.1|-2.4|
71820023|NCT03954158|143142199|OTHER||Least squares mean of difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.2|-0.3||||||Change at Day 15, Intra-participant: Mixed effect Model for Repeated Measures included the fixed effect of day and the covariance structure UN was used.||-0.3|-2.2|
71820024|NCT03954158|143142199|OTHER||Difference of least squares mean|-1.4|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-2.8|-0.1||||||Change at Day 15, Inter-participant: Mixed effect model for repeated measures included the fixed effects of dosing regimen day dosing regimen-by-day interaction and baseline value and the covariance structure UN was used.||-0.1|-2.8|
71820025|NCT02080520|143142213|SUPERIORITY|||||||0.31|||||||Mixed Models Analysis|||||||0.31
71679842|NCT02783729|142877152|SUPERIORITY||LSM Difference|-181.33|STANDARD_ERROR_OF_MEAN|57.255|=|0.0016|TWO_SIDED|95.0|-293.71|-68.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 10 mg||-68.96|-293.71|= 0.0016
71820026|NCT02080520|143142214|SUPERIORITY|||||||0.52|||||||Mixed Models Analysis|||||||0.52
71820027|NCT02080520|143142215|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
71820028|NCT00432679|143142236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|95.0|-1.01|-0.61||Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)|ANCOVA|||||-0.61|-1.01|<0.001
71820029|NCT00432679|143142237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-22.1|STANDARD_ERROR_OF_MEAN|5.06|<|0.001|TWO_SIDED|95.0|-32.1|-12.1|||Unpaired t-test|||||-12.1|-32.1|<0.001
71820030|NCT00432679|143142238|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.718|STANDARD_ERROR_OF_MEAN|0.8102||0.377|TWO_SIDED|95.0|-0.883|2.319|||Unpaired t-test|||||2.319|-0.883|0.377
71820031|NCT00432679|143142239|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.04|STANDARD_ERROR_OF_MEAN|2.094||0.33|TWO_SIDED|95.0|-6.18|2.09|||Unpaired t-test|||||2.09|-6.18|0.330
71820032|NCT00432679|143142240|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.473||0.983|TWO_SIDED|95.0|-0.945|0.925|||Unpaired t-test|||||0.925|-0.945|0.983
71820033|NCT00432679|143142241|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.22|STANDARD_ERROR_OF_MEAN|3.556||0.022|TWO_SIDED|95.0|1.191|15.248|||Unpaired t-test|||||15.248|1.191|0.022
71820034|NCT00432679|143142242|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|8.21|STANDARD_ERROR_OF_MEAN|0.86|<|0.001|TWO_SIDED|95.0|6.52|9.91|||Unpaired t-test|||||9.91|6.52|<0.001
71820035|NCT00432679|143142243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.355||0.069|TWO_SIDED|95.0|-0.05|1.35|||Unpaired t-test||Comparison of leptin.|||1.35|-0.05|0.069
71902177|NCT00436969|143326041|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.028||||0.707|TWO_SIDED|95.0|-4.338|6.393||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.393|-4.338|0.707
71851627|NCT00267956|143217791|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
71851628|NCT00267956|143217792|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.||||<0.001
71851629|NCT00267956|143217793|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.||||<0.001
71851630|NCT02246647|143217794|OTHER||Mean Difference (Final Values)|0.01||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
71851631|NCT03557307|143217809|OTHER||percentage|62.9|||||TWO_SIDED|95.0|58.86|66.76|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieved 100% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||66.76|58.86|
71851632|NCT03557307|143217810|OTHER||percentage|81.9|||||TWO_SIDED|95.0|78.62|84.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve 100% reduction or a daily OCS dose of \<=5mg, if reason for no further OCS reduction is Adrenal Insufficiency, that are sustained over at least 4 weeks without worsening of asthma|||84.94|78.62|
71851633|NCT03557307|143217811|OTHER||percentage|91.5|||||TWO_SIDED|95.0|88.94|93.58|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage of patients who achieve a daily OCS dose of ≤5 mg (regardless of reason for no further OCS reduction), that are sustained over at least 4 weeks without worsening of asthma|||93.58|88.94|
71851634|NCT03557307|143217812|OTHER||percentage|64.0|||||TWO_SIDED|95.0|60.06|67.9|||Clopper-Pearson Exact CI|One sample Confidence Interval (≥90% reduction)|Percentage of patients who achieve \>=90% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||67.90|60.06|
71851635|NCT03557307|143217812|OTHER||percentage|68.9|||||TWO_SIDED|95.0|65.02|72.59|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=75% reduction)|Percentage of patients who achieve \>=75% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||72.59|65.02|
71851636|NCT03557307|143217812|OTHER||percentage|81.8|||||TWO_SIDED|95.0|78.44|84.79|||Clopper-Pearson Exact CI|One sample Confidence Interval (\>=50% reduction)|Percentage of patients who achieve \>=50% reduction in daily OCS dose that are sustained over at least 4 weeks without worsening of asthma|||84.79|78.44|
71851637|NCT03557307|143217813|OTHER||percentage change from baseline|-76.92|||||TWO_SIDED|95.0|-79.9|-73.94|||Clopper-Pearson Exact CI|One sample Confidence Interval|Percentage change from baseline in daily OCS dose at the end of OCS reduction phase|||-73.94|-79.90|
71679843|NCT02783729|142877153|SUPERIORITY||LSM Difference|-0.03|STANDARD_ERROR_OF_MEAN|4.141|=|0.9936|TWO_SIDED|95.0|-8.16|8.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 5 mg||8.09|-8.16|= 0.9936
71851638|NCT01322347|143217818|SUPERIORITY_OR_OTHER||Difference in LS Means between SFP & PBO|3.6|STANDARD_ERROR_OF_MEAN|1.39||0.011|TWO_SIDED|95.0||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA|||||||0.011
71851639|NCT03184519|143217840|SUPERIORITY||Area Under Curve|0.79||||0.025|ONE_SIDED||||||t-test, 1 sided|||||||0.025
71851640|NCT03345407|143217855|OTHER||Posterior adjusted median difference|-0.022|||||TWO_SIDED|95.0|-0.143|0.103|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.103|-0.143|
71851641|NCT03345407|143217855|OTHER||Posterior adjusted median difference|-0.027|||||TWO_SIDED|95.0|-0.098|0.036|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.036|-0.098|
71851642|NCT03345407|143217855|OTHER||Posterior adjusted median difference|-0.038|||||TWO_SIDED|95.0|-0.102|0.028|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.028|-0.102|
71851643|NCT03345407|143217855|OTHER||Posterior adjusted median difference|0.005|||||TWO_SIDED|95.0|-0.064|0.071|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.071|-0.064|
71851644|NCT03345407|143217855|OTHER||Posterior adjusted median difference|-0.003|||||TWO_SIDED|95.0|-0.075|0.061|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.061|-0.075|
71851645|NCT03345407|143217855|OTHER||Posterior adjusted median difference|-0.004|||||TWO_SIDED|95.0|-0.051|0.042|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.|||0.042|-0.051|
71851646|NCT03345407|143217856|OTHER||Posterior median exacerbation rate ratio|0.92|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.|||1.40|0.60|
71851647|NCT03345407|143217856|OTHER||Posterior median exacerbation rate ratio|0.89|||||TWO_SIDED|95.0|0.57|1.35|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.|||1.35|0.57|
71851648|NCT03345407|143217856|OTHER||Posterior median exacerbation rate ratio|1.01|||||TWO_SIDED|95.0|0.65|1.5|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.|||1.50|0.65|
71851649|NCT03345407|143217856|OTHER||Posterior median exacerbation rate ratio|0.63|||||TWO_SIDED|95.0|0.37|1.02|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.|||1.02|0.37|
71679844|NCT02783729|142877153|SUPERIORITY||LSM Difference|-5.85|STANDARD_ERROR_OF_MEAN|4.154|=|0.1595|TWO_SIDED|95.0|-14.0|2.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 10 mg||2.3|-14|= 0.1595
71679845|NCT02783729|142877153|SUPERIORITY||LSM Difference|12.73|STANDARD_ERROR_OF_MEAN|3.894|=|0.0011|TWO_SIDED|95.0|5.09|20.38||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 5 mg||20.38|5.09|= 0.0011
71679846|NCT02783729|142877153|SUPERIORITY||LSM Difference|6.92|STANDARD_ERROR_OF_MEAN|3.913|=|0.0774|TWO_SIDED|95.0|-0.76|14.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 10 mg||14.6|-0.76|= 0.0774
71679847|NCT02783729|142877153|SUPERIORITY||LSM Difference|0.35|STANDARD_ERROR_OF_MEAN|0.393|=|0.3726|TWO_SIDED|95.0|-0.42|1.12||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 5 mg||1.12|-0.42|= 0.3726
71679848|NCT02783729|142877153|SUPERIORITY||LSM Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.394|=|0.2579|TWO_SIDED|95.0|-1.22|0.33||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 10 mg||0.33|-1.22|= 0.2579
71679849|NCT02783729|142877153|SUPERIORITY||LSM Difference|1.39|STANDARD_ERROR_OF_MEAN|0.37|=|0.0002|TWO_SIDED|95.0|0.66|2.11||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 5 mg||2.11|0.66|= 0.0002
71679850|NCT02783729|142877153|SUPERIORITY||LSM Difference|0.59|STANDARD_ERROR_OF_MEAN|0.372|=|0.112|TWO_SIDED|95.0|-0.14|1.32||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 10 mg||1.32|-0.14|= 0.112
71679851|NCT05127304|142877158|OTHER|||||||0.639|||||||Weighted clustered linear regression|||Ambulatory visits||||0.639
71679852|NCT05127304|142877158|OTHER|||||||0.535|||||||Weighted clustered linear regression|||Office visits||||0.535
71679853|NCT05127304|142877158|OTHER|||||||0.337|||||||Weighted clustered linear regression|||Outpatient visits||||0.337
71820036|NCT00432679|143142243|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-888.8|STANDARD_ERROR_OF_MEAN|803.96||0.271|TWO_SIDED|95.0|-2477.7|700.1|||Unpaired t-test||Comparison of hs-CRP|||700.1|-2477.7|0.271
71820037|NCT00432679|143142244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, decrease by 0.7%|||54.1|27.1|
71820038|NCT00432679|143142244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|-0.3|13.8|||||Comparison of HbA1c, fell below 6.5%|||13.8|-0.3|
71851650|NCT03345407|143217856|OTHER||Posterior median exacerbation rate ratio|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.|||1.52|0.85|
71679854|NCT05127304|142877158|OTHER|||||||0.058|||||||Weighted clustered linear regression|||Emergency room visits||||0.058
71679855|NCT05127304|142877158|OTHER|||||||0.192|||||||Weighted clustered linear regression|||Inpatient visits||||0.192
71679856|NCT05127304|142877158|OTHER|||||||0.176|||||||Weighted clustered linear regression|||Other medical visits||||0.176
71679857|NCT05127304|142877159|OTHER|||||||0.313|||||||Weighted clustered linear regression|||||||0.313
71679858|NCT05127304|142877160|OTHER|||||||0.021|||||||Weighted clustered linear regression|||||||0.021
71679859|NCT05127304|142877161|OTHER|||||||0.022|||||||Weighted clustered linear regression|||Ambulatory visits||||0.022
71679860|NCT05127304|142877161|OTHER|||||||0.124|||||||Weighted clustered linear regression|||Office visits||||0.124
71679861|NCT05127304|142877161|OTHER|||||||0.043|||||||Weighted clustered linear regression|||Outpatient visits||||0.043
71679862|NCT05127304|142877161|OTHER|||||||0.99|||||||Weighted clustered linear regression|||Emergency room visits||||0.990
71679863|NCT05127304|142877161|OTHER|||||||0.039|||||||Weighted clustered linear regression|||Inpatient visits||||0.039
71679864|NCT05127304|142877161|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Other medical visits||||<0.001
71679865|NCT05127304|142877162|OTHER|||||||0.163|||||||Weighted clustered linear regression|||||||0.163
71679866|NCT05127304|142877163|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
71679867|NCT05127304|142877164|OTHER|||||||0.017|||||||Weighted clustered linear regression|||Ambulatory visits||||0.017
71679868|NCT05127304|142877164|OTHER|||||||0.098|||||||Weighted clustered linear regression|||Office visits||||0.098
71679869|NCT05127304|142877164|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Outpatient visits||||0.036
71820039|NCT00432679|143142244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.6|||||TWO_SIDED|95.0|27.1|54.1|||||Comparison of HbA1c, satisfied either 1 or 2|||54.1|27.1|
71820040|NCT00432679|143142244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|9.5|36.6|||||Comparison of FPG, decrease of 30 milligrams per decilliter|||36.6|9.5|
71820041|NCT00432679|143142244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.9|||||TWO_SIDED|95.0|-5.1|18.9|||||Comparison of FPG, fell below 126 milligrams per deciliter|||18.9|-5.1|
71820042|NCT00432679|143142244|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|20.5|||||TWO_SIDED|95.0|5.6|35.3|||||Comparison of FPG, satisfied either 1 or 2|||35.3|5.6|
71820043|NCT00600743|143142249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|128.2|STANDARD_ERROR_OF_MEAN|41.4||0.007|TWO_SIDED|95.0||||t test following ANOVA for difference between drug and placebo - There were 3 doses, and the value reported is for the highest and only effective dose|t-test, 2 sided|The overall error term was used to compare differences between placebo and drug||Repeated measures ANOVA||||0.007
71851651|NCT03345407|143217857|OTHER||Posterior median hazard ratio|0.455|||||TWO_SIDED|95.0|0.054|1.103|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.103|0.054|
71851652|NCT03345407|143217857|OTHER||Posterior median hazard ratio|0.991|||||TWO_SIDED|95.0|0.58|1.5|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.500|0.580|
71851653|NCT03345407|143217857|OTHER||Posterior median hazard ratio|0.975|||||TWO_SIDED|95.0|0.581|1.467|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.467|0.581|
71851654|NCT03345407|143217857|OTHER||Posterior median hazard ratio|1.132|||||TWO_SIDED|95.0|0.682|1.709|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.709|0.682|
71851655|NCT03345407|143217857|OTHER||Posterior median hazard ratio|0.556|||||TWO_SIDED|95.0|0.268|0.902|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||0.902|0.268|
71851656|NCT03345407|143217857|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.8|1.539|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.|||1.539|0.800|
71851657|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.01|||||TWO_SIDED|95.0|0.21|2.3|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.30|0.21|
71851658|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.76|2.17|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.76|
71851659|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.99|||||TWO_SIDED|95.0|0.54|1.61|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.61|0.54|
71851660|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.5|1.49|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.50|
71851661|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.75|||||TWO_SIDED|95.0|0.38|1.25|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.25|0.38|
71851662|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.77|1.63|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.63|0.77|
71679870|NCT05127304|142877164|OTHER|||||||0.894|||||||Weighted clustered linear regression|||Emergency room visits||||0.894
71679871|NCT05127304|142877164|OTHER|||||||0.036|||||||Weighted clustered linear regression|||Inpatient visits||||0.036
71851663|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.21|||||TWO_SIDED|95.0|0.36|2.69|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.69|0.36|
71851664|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.82|2.33|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.33|0.82|
71851665|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.67|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.67|
71851666|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.74|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.74|0.63|
71851667|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.55|||||TWO_SIDED|95.0|0.28|0.88|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.88|0.28|
71851668|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.72|1.49|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.49|0.72|
71851669|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.0|||||TWO_SIDED|95.0|0.3|2.17|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.30|
71679872|NCT05127304|142877164|OTHER|||||||0.001|||||||Weighted clustered linear regression|||Other medical visits||||0.001
71679873|NCT05127304|142877165|OTHER|||||||0.162|||||||Weighted clustered linear regression|||||||0.162
71679874|NCT05127304|142877166|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
71679875|NCT05127304|142877167|OTHER|||||||0.065|||||||Weighted clustered linear regression|||Ambulatory visits||||0.065
71679876|NCT05127304|142877167|OTHER|||||||0.102|||||||Weighted clustered linear regression|||Office visits||||0.102
71679877|NCT05127304|142877167|OTHER|||||||0.1|||||||Weighted clustered linear regression|||Outpatient visits||||0.100
71851670|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.46|||||TWO_SIDED|95.0|0.84|2.27|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.84|
71851671|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.15|||||TWO_SIDED|95.0|0.65|1.78|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.78|0.65|
71851672|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.09|||||TWO_SIDED|95.0|0.62|1.67|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.67|0.62|
71851673|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.49|||||TWO_SIDED|95.0|0.26|0.77|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.77|0.26|
71851674|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.71|1.42|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.42|0.71|
71851675|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.32|2.38|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.38|0.32|
71902178|NCT00436969|143326042|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.82||||0.79|TWO_SIDED|95.0|-6.866|5.227||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||5.227|-6.866|0.790
71851676|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.7|2.0|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.70|
71851677|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.12|||||TWO_SIDED|95.0|0.63|1.71|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.71|0.63|
71851678|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.55|1.48|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.55|
71851679|NCT03345407|143217860|OTHER||Posterior median odds ratio|0.56|||||TWO_SIDED|95.0|0.31|0.87|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.87|0.31|
71851680|NCT03345407|143217860|OTHER||Posterior median odds ratio|1.08|||||TWO_SIDED|95.0|0.73|1.47|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.73|
71851681|NCT03345407|143217861|OTHER||Posterior median hazard ratio|1.053|||||TWO_SIDED|95.0|0.477|1.765|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.765|0.477|
71851682|NCT03345407|143217861|OTHER||Posterior median hazard ratio|1.2|||||TWO_SIDED|95.0|0.84|1.597|||||Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.597|0.840|
71851683|NCT03345407|143217861|OTHER||Posterior median hazard ratio|1.06|||||TWO_SIDED|95.0|0.734|1.432|||||Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.432|0.734|
71851684|NCT03345407|143217861|OTHER||Posterior median hazard ratio|1.03|||||TWO_SIDED|95.0|0.719|1.413|||||Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.413|0.719|
71851685|NCT03345407|143217861|OTHER||Posterior median hazard ratio|0.751|||||TWO_SIDED|95.0|0.487|1.057|||||Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.057|0.487|
71851686|NCT03345407|143217861|OTHER||Posterior median hazard ratio|1.149|||||TWO_SIDED|95.0|0.899|1.426|||||Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.|||1.426|0.899|
71851687|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.22|||||TWO_SIDED|95.0|0.35|2.7|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.70|0.35|
71851688|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.63|1.77|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.77|0.63|
71851689|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.41|||||TWO_SIDED|95.0|0.77|2.17|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.17|0.77|
71851690|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.28|||||TWO_SIDED|95.0|0.71|2.0|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.00|0.71|
71851691|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.11|||||TWO_SIDED|95.0|0.61|1.75|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.75|0.61|
71851692|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.7|||||TWO_SIDED|95.0|0.46|0.99|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||0.99|0.46|
71851693|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.64|||||TWO_SIDED|95.0|0.2|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.20|
71851694|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.84|2.46|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.46|0.84|
71851695|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.53|1.48|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.48|0.53|
71851696|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.36|||||TWO_SIDED|95.0|0.74|2.16|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.16|0.74|
71851697|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.76|||||TWO_SIDED|95.0|0.43|1.17|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.43|
71902179|NCT00436969|143326043|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.13||||0.685|TWO_SIDED|95.0|-4.341|6.001||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||6.001|-4.341|0.685
71902180|NCT00436969|143326044|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.317||||0.018|TWO_SIDED|95.0|1.249|13.386||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||13.386|1.249|0.018
71902181|NCT00436969|143326045|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.361||||0.369|TWO_SIDED|95.0|-2.801|7.522||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||7.522|-2.801|0.369
71902182|NCT00436969|143326046|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.79||||0.41|TWO_SIDED|95.0|-9.441|3.861||The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.||3.861|-9.441|0.410
71902183|NCT00436969|143326047|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.617||||0.379|TWO_SIDED|95.0|-3.226|8.46||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||8.460|-3.226|0.379
71902184|NCT00436969|143326048|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.208||||0.409|TWO_SIDED|95.0|-7.455|3.039||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.039|-7.455|0.409
71902185|NCT00436969|143326049|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.558||||0.232|TWO_SIDED|95.0|-4.119|1.003||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||1.003|-4.119|0.232
71902186|NCT00436969|143326050|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.228||||0.832|TWO_SIDED|95.0|-2.343|1.887||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||1.887|-2.343|0.832
71902187|NCT00436969|143326051|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.068||||0.957|TWO_SIDED|95.0|-2.396|2.532||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.532|-2.396|0.957
71902188|NCT00436969|143326052|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.22||||0.267|TWO_SIDED|95.0|-0.937|3.378||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||3.378|-0.937|0.267
71902189|NCT00436969|143326053|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.19||||0.333|TWO_SIDED|95.0|-1.225|3.604||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||3.604|-1.225|0.333
71820044|NCT00600743|143142250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.4|STANDARD_ERROR_OF_MEAN|22.8||0.033|TWO_SIDED|95.0||||t-test after ANOVA with repeated measures on placebo minus drug (within groups) between binge and normal instructions (between groups)|t-test, 2 sided|This was part of an overall ANOVA (SAS proc mixed) with all four groups (3 doses eat normally. 4 ng dose, binge eat) and the error term had 76 df.||Each group was compared separately in an overall ANOVA with all dose groups included. The results are presented for the groups which received 4 mg dose and instructions to eat normally (normal group) or to binge eat (binge group). The test is the interaction between drug and group i.e. drug effect difference (placebo minus drug) in fullness between the group instructed to binge and the group instructed to eat normally.||||.033
71820045|NCT00600743|143142251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4286|STANDARD_ERROR_OF_MEAN|13.134|<|0.014|TWO_SIDED|||||p-value is based on ANOVA with all groups and conditions and is a planned comparison|ANOVA||df = 53. 26 Used proc GLMMIX in SAS 9.4.|Tests the difference between drug and placebo for group = binge instructions||||<.014
71820046|NCT01177813|143142252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.9|-0.57||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.57|-0.90|<0.0001
71820047|NCT01177813|143142252|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-1.01|-0.69||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate||-0.69|-1.01|<0.0001
71820048|NCT01177813|143142253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|97.5|-2.48|-1.38||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.38|-2.48|<0.0001
71820049|NCT01177813|143142253|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.7|-1.6||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate||-1.60|-2.70|<0.0001
71851698|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.93|||||TWO_SIDED|95.0|0.63|1.27|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.27|0.63|
71851699|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.16|1.2|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.20|0.16|
71851700|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.53|||||TWO_SIDED|95.0|0.79|2.56|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.56|0.79|
71851701|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.83|||||TWO_SIDED|95.0|0.46|1.3|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.30|0.46|
71851702|NCT03345407|143217863|OTHER||Posterior median odds ratio|1.16|||||TWO_SIDED|95.0|0.62|1.86|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.86|0.62|
71851703|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.65|||||TWO_SIDED|95.0|0.36|1.02|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.02|0.36|
71851704|NCT03345407|143217863|OTHER||Posterior median odds ratio|0.85|||||TWO_SIDED|95.0|0.57|1.17|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.17|0.57|
71851705|NCT03345407|143217864|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-0.5|5.2|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.2|-0.5|
71851706|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.7|||||TWO_SIDED|95.0|-0.8|2.3|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-0.8|
71851707|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.8|2.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.8|
71851708|NCT03345407|143217864|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-2.0|1.2|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.2|-2.0|
71851709|NCT03345407|143217864|OTHER||Posterior adjacent median difference|1.6|||||TWO_SIDED|95.0|0.0|3.3|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.3|0.0|
71820050|NCT01177813|143142254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.1||0.0231|TWO_SIDED|97.5|-5.2|0.0||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for Systolic Blood Pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||0.0|-5.2|0.0231
71820051|NCT01177813|143142254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0028|TWO_SIDED|97.5|-6.0|-0.9||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for Systolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"||-0.9|-6.0|0.0028
71820052|NCT01177813|143142254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.3987|TWO_SIDED|97.5|-2.1|0.9||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.9|-2.1|0.3987
71820053|NCT01177813|143142254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0296|TWO_SIDED|97.5|-3.0|0.0||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"||0.0|-3.0|0.0296
71820054|NCT00581256|143142256|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||A Perfusion Defect (PD) increase of greater than 5% for a 2.5 SD threshold was considered significant.||||0.6
71820055|NCT00581256|143142256|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||A PD increase of greater than 10% for a 1.5 SD threshold was considered significant.||||0.46
71820056|NCT01196104|143142264|NON_INFERIORITY_OR_EQUIVALENCE|Study terminated early due to business reasons, results are not properly powered.|Mean Difference (Final Values)|-0.0473|STANDARD_ERROR_OF_MEAN|0.2158||0.8283|TWO_SIDED|95.0|-0.4901|0.3956|||ANCOVA|||ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate||0.3956|-0.4901|0.8283
71851710|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-1.1|
71851711|NCT03345407|143217864|OTHER||Posterior adjusted median difference|2.3|||||TWO_SIDED|95.0|-0.5|5.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.4|-0.5|
71851712|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.4|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.4|-0.9|
71851713|NCT03345407|143217864|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-1.9|1.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.4|-1.9|
71851714|NCT03345407|143217864|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.0|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-2.3|
71851715|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-1.2|2.2|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.2|-1.2|
71851716|NCT03345407|143217864|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.0|-1.4|
71851717|NCT03345407|143217864|OTHER||Posterior adjusted median difference|1.9|||||TWO_SIDED|95.0|-1.4|5.1|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||5.1|-1.4|
71851718|NCT03345407|143217864|OTHER||Posterior adjusted median difference|1.1|||||TWO_SIDED|95.0|-0.7|2.8|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.7|
71851719|NCT03345407|143217864|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-2.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.|||1.1|-2.3|
71902190|NCT00436969|143326054|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.771||||0.473|TWO_SIDED|95.0|-1.339|2.881||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.881|-1.339|0.473
71902191|NCT00436969|143326055|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.018||||0.988|TWO_SIDED|95.0|-2.314|2.278||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.||2.278|-2.314|0.988
71851720|NCT03345407|143217864|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-1.9|1.7|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-1.9|
71851721|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.8|||||TWO_SIDED|95.0|-0.9|2.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.8|-0.9|
71820057|NCT00267111|143142298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant.|t-test, 2 sided|||We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of \< 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.||||< 0.05
71820058|NCT00267111|143142299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of \< 0.05 was considered significant|t-test, 2 sided|||We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.||||<0.05
71820059|NCT02368002|143142347|SUPERIORITY|||||||0.25||||||2 df re-random\*time interaction tested if baseline to 6M or 18M PCM and ABT weight changes differed; primary hypothesis tests were 2 planned contrasts estimating baseline to 6M (H1a, expected neg) and 18M (H1b, expected pos) PCM vs. ABT weight change|Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, TRA timing, sex, weight loss rate.||H1 predicted that suboptimal responders re-randomized to PCM would lose more weight at 6m (H1a) while those re-randomized to ABT would lose more weight at 18m (H1b). A mixed linear model predicted weight change from fixed re-randomization, measurement time, the re-randomization by measurement time interaction and covariate parameters.|The primary hypothesis tests were two planned contrasts that estimated weight change from baseline to 6M and 18M relative to baseline in PCM relative to ABT. A mixed linear model predicted weight changes between baseline and post-baseline for suboptimal responders, and this model included two a priori simple effects tests resulting in two mean differences, confidence intervals, and p-values. H1a: -2.7 lbs; 95% CI: -5.8, 0.5; p=0.09. H1b: -1.0 lbs; 95% CI: -4.2, 2.2; p=0.53|||0.25
71820060|NCT02368002|143142348|SUPERIORITY||Mean Difference (Net)|-0.1||||0.96|TWO_SIDED|95.0|-2.4|2.3|||Mixed Models Analysis|The mixed model included a random participant intercept. Fixed covariates were baseline weight, sex, TRA result (PCM, ABT, responder, pre-TRA quit).||Hypothesis 2 predicted that among all participants, those randomized to Early TRA would lose more weight at 6 and 18 months than those randomized to Late TRA. A mixed linear model predicted weight change from fixed treatment response assessment timing and covariate parameters.||2.3|-2.4|0.96
71820061|NCT01183650|143142380|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.05|||||TWO_SIDED|90.0|0.84|1.32|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.32|0.84|
71820062|NCT01183650|143142380|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.8|||||TWO_SIDED|90.0|0.64|1.0|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.00|0.64|
71851722|NCT03345407|143217864|OTHER||Posterior adjusted median difference|0.4|||||TWO_SIDED|95.0|-0.8|1.7|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.7|-0.8|
71851723|NCT03345407|143217865|OTHER||Posterior median odds ratio|0.51|||||TWO_SIDED|95.0|0.03|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.41|0.03|
71820063|NCT01183650|143142380|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.31|||||TWO_SIDED|90.0|1.05|1.64|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.64|1.05|
71851724|NCT03345407|143217865|OTHER||Posterior median odds ratio|0.87|||||TWO_SIDED|95.0|0.42|1.47|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.47|0.42|
71851725|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.37|||||TWO_SIDED|95.0|0.69|2.24|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.24|0.69|
71851726|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.78|||||TWO_SIDED|95.0|0.95|2.91|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.91|0.95|
71851727|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.24|||||TWO_SIDED|95.0|0.61|2.08|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.08|0.61|
71851728|NCT03345407|143217865|OTHER||Posterior median odds ratio|0.95|||||TWO_SIDED|95.0|0.6|1.4|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.40|0.60|
71902192|NCT00436969|143326056|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.467||||0.671|TWO_SIDED|95.0|-1.692|2.627||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p \<0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.||2.627|-1.692|0.671
71902193|NCT04490265|143326069|SUPERIORITY||Cohen's d|0.33|||||TWO_SIDED|||||||||||||
71902194|NCT04490265|143326070|SUPERIORITY||Cohen's d|0.78|||||TWO_SIDED|||||||||||||
71902195|NCT04490265|143326075|SUPERIORITY||Cohen's d|0.14|||||TWO_SIDED|||||||||Belonging Subscale change from baseline to 12-weeks||||
71902196|NCT04490265|143326075|SUPERIORITY||Cohen's D|0.05|||||TWO_SIDED|||||||||Belonging subscale Baseline to 6-months||||
71902197|NCT04490265|143326075|SUPERIORITY||Cohen's D|0.6|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 12-weeks||||
71820064|NCT01183650|143142380|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.99|||||TWO_SIDED|90.0|0.79|1.24|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.24|0.79|
71820065|NCT01183650|143142381|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.98|||||TWO_SIDED|90.0|0.81|1.18|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means(Japanese/Caucasian)|||1.18|0.81|
71820066|NCT01183650|143142381|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.81|||||TWO_SIDED|90.0|0.67|0.97|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||0.97|0.67|
71820067|NCT01183650|143142381|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.33|||||TWO_SIDED|90.0|1.07|1.67|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.67|1.07|
71820068|NCT01183650|143142381|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.03|||||TWO_SIDED|90.0|0.83|1.29|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)|||1.29|0.83|
71851729|NCT03345407|143217865|OTHER||Posterior median odds ratio|0.54|||||TWO_SIDED|95.0|0.14|1.16|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.16|0.14|
71820069|NCT01183650|143142382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Japanese Participants||||||
71851730|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.74|1.98|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.98|0.74|
71820070|NCT01183650|143142382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||||95.0|||||Wilcoxon (Mann-Whitney)|Tadalafil Median Difference (Day 1 - Day 10) in Caucasian Participants||||||
71820071|NCT01183650|143142382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|19.83||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Japanese participants||||||
71902198|NCT04490265|143326075|SUPERIORITY||Cohen's D|0.43|||||TWO_SIDED|||||||||Change in Burdensome subscale Baseline to 6 months||||
71851731|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.29|||||TWO_SIDED|95.0|0.73|1.97|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.97|0.73|
71851732|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.47|||||TWO_SIDED|95.0|0.83|2.27|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.27|0.83|
71851733|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.04|||||TWO_SIDED|95.0|0.57|1.62|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.62|0.57|
71820072|NCT01183650|143142382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.02||||||95.0|||||Wilcoxon (Mann-Whitney)|Metabolite IC710 Median Difference (Day 1 - Day 10) in Caucasian participants||||||
71820073|NCT01284140|143142383|OTHER|||||||0.37|||||||Extra sum-of-squares F test|The null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was not rejected for the Usual Care group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Usual Care group.||||0.37
71820074|NCT01284140|143142383|OTHER|||||||0.0074|||||||Extra sum-of-squares F test|This result suggests that the best-fit values for amplitude and phase are different between Day 1 and Day 3 in the Sleep Promotion group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Sleep promotion group.||||0.0074
71820075|NCT01284140|143142384|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
71820076|NCT01284140|143142385|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.03|TWO_SIDED||||||t-test, 2 sided|||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. This resulted in 4 separate best-fit curves. The model parameter of amplitude was derived from the best-fit curves.||||0.03
71820077|NCT00579982|143142388|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Paired t-test|t-test, 2 sided|||||||<0.001
71820078|NCT03192215|143142416|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.64|1.55|||Log Rank|||||1.55|0.64|0.99
71820079|NCT03192215|143142417|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.59|1.44|||Log Rank|||||1.44|0.59|0.72
71820080|NCT03192215|143142418|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.67|TWO_SIDED|95.0|0.76|1.52|||Log Rank|||||1.52|0.76|0.67
71820081|NCT03192215|143142419|SUPERIORITY||Difference of annual rate.|-0.011||||0.02|TWO_SIDED|95.0|-0.018|-0.003|||Exact Binomial Test|||||-0.003|-0.018|.02
71820082|NCT03192215|143142420|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.29|3.52|||Log Rank|||||3.52|0.29|0.98
71820083|NCT03192215|143142421|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.35|TWO_SIDED|95.0|0.63|3.75|||Log Rank|||||3.75|0.63|0.35
71820084|NCT02593032|143142422|SUPERIORITY||Mean Difference (Net)|12.0|||<|0.05|TWO_SIDED|||||This is the calculated p-value, not a threshold.|t-test, 2 sided|||||||<0.05
71820085|NCT05199233|143142423|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
71902199|NCT04490265|143326076|SUPERIORITY||Cohen's D|0.07|||||TWO_SIDED|||||||||Baseline to 12-weeks||||
71902200|NCT04490265|143326076|SUPERIORITY||Cohen's D|0.13|||||TWO_SIDED|||||||||Baseline to 6-months||||
71902201|NCT04490265|143326077|SUPERIORITY||Cohen's d|0.6|||||TWO_SIDED|||||||||||||
71902202|NCT04490265|143326078|SUPERIORITY||Cohen's d|0.52|||||TWO_SIDED|||||||||||||
71902203|NCT04490265|143326079|SUPERIORITY||Cohen's d|0.21|||||TWO_SIDED|||||||||||||
71902204|NCT04490265|143326080|SUPERIORITY||Cohen's d|0.2|||||TWO_SIDED|||||||||||||
71902205|NCT04490265|143326081|SUPERIORITY||Cohen's d|0.66|||||TWO_SIDED|||||||||||||
71820086|NCT05199233|143142424|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|The mean change from baseline was compared to zero using a one-sample t-test.||||||<0.001
71820087|NCT02471404|143142441|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|0.0294|0.2986|||Mixed Models Analysis|||||0.2986|0.0294|
71820088|NCT02471404|143142441|NON_INFERIORITY|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|-0.21||||0.001|TWO_SIDED|95.0|-0.3443|-0.0825||(superiority)|Mixed Models Analysis|||||-0.0825|-0.3443|0.001
71820089|NCT02471404|143142442|SUPERIORITY||Risk Difference (RD)|-4.21|STANDARD_ERROR_OF_MEAN|1.14|<|0.001|TWO_SIDED|95.0|-6.45|-1.97|||Fisher Exact|||||-1.97|-6.45|<0.001
71820090|NCT02471404|143142442|SUPERIORITY||Risk Difference (RD)|-3.89|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|-6.21|-1.56|||Fisher Exact|||||-1.56|-6.21|<0.001
71820091|NCT02471404|143142443|SUPERIORITY||Mean Difference (Final Values)|-5.3|||<|0.001|TWO_SIDED|95.0|-5.93|-4.67|||Mixed Models Analysis|||||-4.67|-5.93|<0.001
71820092|NCT02471404|143142443|SUPERIORITY||Mean Difference (Final Values)|-4.91|||<|0.001|TWO_SIDED|95.0|-5.52|-4.29|||Mixed Models Analysis|||||-4.29|-5.52|<0.001
71820093|NCT02471404|143142444|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.374|TWO_SIDED|95.0|-0.43|0.16|||Mixed Models Analysis|||||0.16|-0.43|0.374
71820094|NCT02471404|143142444|SUPERIORITY||Mean Difference (Final Values)|-0.59|||<|0.001|TWO_SIDED|95.0|-0.88|-0.31|||Mixed Models Analysis|||||-0.31|-0.88|<0.001
71820095|NCT02471404|143142445|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.777|TWO_SIDED|95.0|0.67|1.35|||Regression, Cox|||||1.35|0.67|0.777
71851734|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.1|||||TWO_SIDED|95.0|0.75|1.5|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.50|0.75|
71851735|NCT03345407|143217865|OTHER||Posterior median odds ratio|0.63|||||TWO_SIDED|95.0|0.17|1.39|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.39|0.17|
71902206|NCT04490265|143326082|SUPERIORITY||cohen's d|0.38|||||TWO_SIDED|||||||||||||
71820096|NCT02471404|143142445|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.001|TWO_SIDED|95.0|0.23|0.57|||Regression, Cox|||||0.57|0.23|<0.001
71820097|NCT02144519|143142452|SUPERIORITY||Odds Ratio (OR)|1.88||||0.008|TWO_SIDED|95.0|1.18|3.0|||Mixed Models Analysis|||||3.00|1.18|0.008
71820098|NCT02144519|143142453|SUPERIORITY||Odds Ratio (OR)|3.8||||0.003|TWO_SIDED|95.0|1.45|9.95|||Regression, Logistic|||||9.95|1.45|0.003
71820099|NCT00614198|143142454|SUPERIORITY_OR_OTHER||||||<|0.01||||||A priori p threshold set for stage 1 (baseline - 8m; p\<0.01) or (baseline - 12 months, p\<0.05) in order to progress to stage 2 (8 or 12 months - 20 or 24 months).|Mixed Models Analysis|||1st stage analysis (baseline-8m or 12m) used a repeated measures model for all assessment measures. Model included baseline, age, time and time\*treatment interaction. Results informed 2nd stage (8 or 12 months - 20 or 24 months). 2nd stage analysis based on various statistical scenarios (baseline vs 12 months on intervention, 12 months of no intervention vs 12 on intervention, baseline vs 24 months on intervention). No ADOS assessments were used at 12 months because of risk of practice effects.||||<0.01
71820100|NCT00065468|143142456|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.78||||0.0252|TWO_SIDED|95.0|0.63|0.97|||Log Rank|Stratified by prior nephrectomy and region||||0.97|0.63|0.0252
71820101|NCT00065468|143142456|NON_INFERIORITY_OR_EQUIVALENCE|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.93||||0.4902|TWO_SIDED|95.0|0.75|1.15|||Log Rank|Stratified by prior nephrectomy and region||||1.15|0.75|0.4902
71820102|NCT00065468|143142457|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.74||||0.0042|TWO_SIDED|95.0|0.6|0.91|||Log Rank|Stratified by prior nephrectomy and region||||0.91|0.60|0.0042
71820103|NCT00065468|143142457|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76||||0.0107|TWO_SIDED|95.0|0.62|0.94|||Log Rank|Stratified by prior nephrectomy and region||||0.94|0.62|0.0107
71820104|NCT00065468|143142458|SUPERIORITY_OR_OTHER|||||||0.1361|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1361
71820105|NCT00065468|143142458|SUPERIORITY_OR_OTHER|||||||0.1062|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.1062
71820106|NCT00065468|143142459|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||<0.0001
71820107|NCT00065468|143142459|SUPERIORITY_OR_OTHER|||||||0.0011|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region||||||0.0011
71851736|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.27|||||TWO_SIDED|95.0|0.72|2.01|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.01|0.72|
71851737|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.13|||||TWO_SIDED|95.0|0.64|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.79|0.64|
71851738|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.35|||||TWO_SIDED|95.0|0.75|2.14|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||2.14|0.75|
71851739|NCT03345407|143217865|OTHER||Posterior median odds ratio|0.94|||||TWO_SIDED|95.0|0.53|1.45|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.45|0.53|
71820108|NCT00065468|143142461|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76|||Log Rank|Stratified by prior nephrectomy and region||||0.76|0.51|<0.0001
71679878|NCT05127304|142877167|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Emergency room visits||||0.189
71820109|NCT00065468|143142461|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73||||0.002|TWO_SIDED|95.0|0.6|0.89|||Log Rank|Stratified by prior nephrectomy and region||||0.89|0.60|0.0020
71820110|NCT01225835|143142464|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.003
71820111|NCT01225835|143142464|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \< 39 years||||0.015
71820112|NCT01225835|143142464|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||The significance level is 0.05.|t-test, 2 sided|||Age \>= 39 years||||0.027
71820113|NCT01225835|143142466|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05.|Fisher Exact|||||||1.00
71851740|NCT03345407|143217865|OTHER||Posterior median odds ratio|1.03|||||TWO_SIDED|95.0|0.71|1.43|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.|||1.43|0.71|
71851741|NCT03345407|143217866|OTHER||Posterior adjusted median difference|2.0|||||TWO_SIDED|95.0|-4.8|8.3|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||8.3|-4.8|
71851742|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.5|||||TWO_SIDED|95.0|-4.0|3.1|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.1|-4.0|
71851743|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-2.9|||||TWO_SIDED|95.0|-6.2|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.2|
71851744|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-3.2|||||TWO_SIDED|95.0|-6.7|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-6.7|
71851745|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.1|||||TWO_SIDED|95.0|-4.0|3.5|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.5|-4.0|
71851746|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-2.7|2.3|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-2.7|
71851747|NCT03345407|143217866|OTHER||Posterior adjusted median difference|4.1|||||TWO_SIDED|95.0|-2.5|11.0|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||11.0|-2.5|
71851748|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-1.2|||||TWO_SIDED|95.0|-4.8|2.5|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-4.8|
71851749|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-2.7|||||TWO_SIDED|95.0|-6.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.1|-6.3|
71902207|NCT04490265|143326083|SUPERIORITY||Cohens d|0.47|||||TWO_SIDED|||||||||Severity||||
71902208|NCT04490265|143326083|SUPERIORITY||Cohens d|0.46|||||TWO_SIDED|||||||||interference||||
71902209|NCT04490265|143326084|SUPERIORITY||Cohens d|0.64|||||TWO_SIDED|||||||||Severity Subscale||||
71902210|NCT04490265|143326084|SUPERIORITY||Cohen's d|0.38|||||TWO_SIDED|||||||||Interference subscale||||
71679879|NCT05127304|142877167|OTHER|||||||0.024|||||||Weighted clustered linear regression|||Inpatient visits||||0.024
71679880|NCT05127304|142877167|OTHER|||||||0.767|||||||Weighted clustered linear regression|||Other medical visits||||0.767
71851750|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-3.3|||||TWO_SIDED|95.0|-7.3|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||0.4|-7.3|
71851751|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.0|-4.6|
71851752|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.4|||||TWO_SIDED|95.0|-2.9|2.5|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.5|-2.9|
71851753|NCT03345407|143217866|OTHER||Posterior adjusted median difference|2.4|||||TWO_SIDED|95.0|-4.8|9.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||9.4|-4.8|
71851754|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.2|||||TWO_SIDED|95.0|-4.1|3.6|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.6|-4.1|
71851755|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-2.3|||||TWO_SIDED|95.0|-6.1|1.8|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||1.8|-6.1|
71851756|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-1.8|||||TWO_SIDED|95.0|-5.7|2.3|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||2.3|-5.7|
71851757|NCT03345407|143217866|OTHER||Posterior adjusted median difference|-0.3|||||TWO_SIDED|95.0|-4.5|3.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||3.8|-4.5|
71679881|NCT05127304|142877168|OTHER|||||||0.357|||||||Weighted clustered linear regression|||||||0.357
71851758|NCT03345407|143217866|OTHER||Posterior adjusted median difference|1.2|||||TWO_SIDED|95.0|-1.7|4.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.|||4.0|-1.7|
71851759|NCT00065611|143217881|SUPERIORITY_OR_OTHER|||||||0.9074||95.0|||||Chi-squared|||||||0.9074
71851760|NCT00065611|143217882|SUPERIORITY_OR_OTHER|||||||0.4566||95.0|||||ANOVA|||||||0.4566
71902211|NCT00962000|143326085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.02217|||TWO_SIDED|95.0|-0.064|0.024||There is no p values because the power calculation is based on the primary outcome variable|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.024|-0.064|
71851761|NCT00065611|143217883|SUPERIORITY_OR_OTHER|||||||0.3792||95.0|||||ANOVA|||||||0.3792
71820114|NCT01225835|143142467|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.004
71820115|NCT01225835|143142468|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||The significance level is 0.05.|t-test, 2 sided|||||||0.121
71820116|NCT01225835|143142469|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Level of significance is 0.05.|Wilcoxon (Mann-Whitney)|||||||<0.001
71820117|NCT01225835|143142470|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
71820118|NCT01225835|143142472|SUPERIORITY_OR_OTHER|||||||0.482||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.482
71851762|NCT01951105|143217914|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71820119|NCT01225835|143142473|SUPERIORITY_OR_OTHER|||||||0.871||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Chi-squared|||||||0.871
71851763|NCT00379210|143217916|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANOVA|||Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha level||||<0.01
71851764|NCT01601821|143217926|SUPERIORITY_OR_OTHER||percent difference|-2.0||||0.341|TWO_SIDED|90.0|-5.5|1.5|||Chi-squared|||Chi-square test was used to test superiority of arm CsA+Rapamune+CS versus arm CsA+MMF+CS.||1.5|-5.5|0.341
71851765|NCT01601821|143217927|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way analysis of variance (ANOVA) was used to test the difference.||||0.870
71851766|NCT01601821|143217927|SUPERIORITY_OR_OTHER|||||||0.381|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.381
71851767|NCT01601821|143217927|SUPERIORITY_OR_OTHER|||||||0.096|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.096
71851768|NCT01601821|143217928|SUPERIORITY_OR_OTHER|||||||0.979|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.979
71851769|NCT01601821|143217928|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.660
71851770|NCT01601821|143217928|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.518
71820120|NCT01225835|143142474|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||<0.001
71820121|NCT01225835|143142475|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.620
71820122|NCT01225835|143142476|SUPERIORITY_OR_OTHER|||||||0.478||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided|||||||0.478
71820123|NCT01225835|143142477|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||0.69
71820124|NCT01225835|143142478|SUPERIORITY_OR_OTHER|||||||0.295||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.295
71820125|NCT01225835|143142479|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)|||||||0.405
71820126|NCT01225835|143142480|SUPERIORITY_OR_OTHER|||||||1||95.0||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact|||||||1.000
71820127|NCT05515679|143142489|SUPERIORITY||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.48|<|0.01|TWO_SIDED|95.0|0.51|0.94|||t-test, 2 sided|||Using a paired sample t-test (two tailed), we wished to examine whether there was an increase in Constructive Engagement and Pleasure and a reduction in Passive Engagement, Distracted Engagement, and Non-Engagement, from baseline to treatment. With an anticipated PWD sample of 24, and using means and standard deviations from the PI's previous studies, we calculated a power of 90% to detect effects (alpha = .05; one-tailed test). (3) PWD and staff report high satisfaction wi||.94|.51|<0.01
71851771|NCT01601821|143217929|SUPERIORITY_OR_OTHER|||||||0.786|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.||||0.786
71851772|NCT01601821|143217929|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.||||0.738
71851773|NCT01601821|143217929|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED|||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.||||0.977
71902212|NCT00962000|143326086|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.01849|||TWO_SIDED|95.0|-0.051|0.023||There is no p value for eKt/V because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|The three centers and the two flow rates were treated as fixed effects and the subjects within centers modeled as a random effect.||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.023|-0.051|
71902213|NCT00962000|143326087|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03103||||95.0|-0.029|0.099||There is no p value for Kt/VID because the power calculation is based on the primary outcome variable (Kt/Vsp) alone.|ANOVA|||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.||0.099|-0.029|
71902214|NCT02702193|143326088|SUPERIORITY||Slope|-0.24|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|95.0|||||Generalized Estimating Equations (GEE)|GEE allowed the examination of trajectories from baseline through the 12 month follow-up.||To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén \& Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.||||<.05
71902215|NCT01201798|143326106|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.|Mean Difference (Net)|-0.22|||||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.||0.09|-0.53|
71902216|NCT04590937|143326163|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.22|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.89|101.67|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.67|94.89|
71902217|NCT04590937|143326164|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|123.08|STANDARD_ERROR_OF_MEAN|12.7|||TWO_SIDED|90.0|112.22|134.98|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||134.98|112.22|
71902218|NCT04590937|143326165|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|117.72|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|110.57|125.34|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||125.34|110.57|
71902219|NCT04590937|143326166|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|170.29|STANDARD_ERROR_OF_MEAN|25.6|||TWO_SIDED|90.0|143.73|201.76|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.76|143.73|
71902220|NCT04590937|143326167|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|91.42|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|90.0|88.04|94.93|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||94.93|88.04|
71902221|NCT04590937|143326168|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|139.03|STANDARD_ERROR_OF_MEAN|16.9|||TWO_SIDED|90.0|124.29|155.51|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||155.51|124.29|
71902222|NCT04590937|143326169|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|112.1|STANDARD_ERROR_OF_MEAN|15.4|||TWO_SIDED|90.0|101.26|124.11|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||124.11|101.26|
71902223|NCT04590937|143326170|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|161.29|STANDARD_ERROR_OF_MEAN|34.1|||TWO_SIDED|90.0|129.17|201.39|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||201.39|129.17|
71902224|NCT04590937|143326171|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|98.23|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|90.0|94.86|101.73|||||The geometric means ratio was calculated as Metformin + BI 730357 / Metformin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||101.73|94.86|
71902225|NCT04590937|143326172|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|118.67|STANDARD_ERROR_OF_MEAN|13.0|||TWO_SIDED|90.0|108.83|129.4|||||The geometric means ratio was calculated as Rosuvastatin + BI 730357 / Rosuvastatin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||129.40|108.83|
71902226|NCT04590937|143326173|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|114.07|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|107.93|120.56|||||The geometric means ratio was calculated as Furosemide + BI 730357 / Furosemide. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||120.56|107.93|
71902227|NCT04590937|143326174|OTHER|"ANOVA model including subject as random and treatment as fixed effect was used."|Geometric means ratio|173.77|STANDARD_ERROR_OF_MEAN|30.8|||TWO_SIDED|90.0|141.9|212.8|||||The geometric means ratio was calculated as Digoxin + BI 730357 / Digoxin. Standard error of the mean is actually the intra-individual geometric coefficient of variation (gCV).|||212.80|141.90|
71902228|NCT04743635|143326185|OTHER|"Performance goal.~Hypothesis:~Ho: D \< 1 Ha: D ≥ 1, where D = reduction in the CSS score from baseline to 3 months, and 1 is the performance goal. If the lower bound of the two-sided 95% confidence interval is greater than or equal to 1 then we will reject the null hypothesis and conclude the device performs effectively."|Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|0.9||0.0001|TWO_SIDED|95.0|1.28|1.71|||t-test, 2 sided|The 2-sided 95% confidence interval for the mean reduction in CSS was calculated along with the corresponding p-value (Student's t-test).||The endpoint tested the mean of the changes for each treated participant, not a 1-point change between mean score of the group at baseline versus 3 months. Success is achieved when the mean change across all treated participants is at least one point.||1.71|1.28|.0001
71820128|NCT05515679|143142490|SUPERIORITY||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|0.6||0.017|TWO_SIDED|95.0|-0.59|-0.07|||t-test, 2 sided|||||-0.07|-0.59|.017
71820129|NCT05515679|143142491|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_DEVIATION|0.41||0.008|TWO_SIDED|95.0|-0.43|-0.07|||t-test, 2 sided|||||-0.07|-0.43|.008
71820130|NCT05515679|143142492|SUPERIORITY||Median Difference (Final Values)|-0.15|STANDARD_DEVIATION|0.34||0.053|TWO_SIDED|95.0|-0.3|0.0|||t-test, 2 sided|||||-.00|-.30|0.053
71820131|NCT05515679|143142493|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|0.28|<|0.01|TWO_SIDED|95.0|0.54|0.79|||t-test, 2 sided|||||.79|.54|<.01
71820132|NCT05515679|143142494|SUPERIORITY||Mean Difference (Final Values)|4.11|STANDARD_DEVIATION|3.35|<|0.001|TWO_SIDED|95.0|2.62|5.6|||t-test, 2 sided|||||5.60|2.62|<.001
71820133|NCT05515679|143142495|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|1.1|<|0.001|TWO_SIDED|95.0|-1.55|-0.58|||t-test, 2 sided|||||-0.58|-1.55|<.001
71820134|NCT05515679|143142496|SUPERIORITY||Median Difference (Final Values)|6.02|STANDARD_DEVIATION|11.4||0.022|TWO_SIDED|95.0|0.97|11.1|||t-test, 2 sided|||||11.1|0.97|.022
71820135|NCT05515679|143142497|SUPERIORITY||Mean Difference (Final Values)|1.23|STANDARD_DEVIATION|9.5||0.551|TWO_SIDED|95.0|-2.9|5.44|||t-test, 2 sided|||||5.44|-2.90|.551
71820136|NCT05515679|143142498|SUPERIORITY||Mean Difference (Final Values)|27.43|STANDARD_DEVIATION|0.11|<|0.001|TWO_SIDED|95.0|17.7|37.2|||t-test, 2 sided|||||37.2|17.7|<.001
71820137|NCT01952301|143142518|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71851774|NCT01601821|143217930|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
71851775|NCT01601821|143217932|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.276
71851776|NCT01601821|143217933|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
71851777|NCT01601821|143217934|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.868
71851778|NCT01601821|143217935|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.999
71851779|NCT01601821|143217936|SUPERIORITY_OR_OTHER|||||||0.985|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.985
71851780|NCT01601821|143217937|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher's exact test was used to test the difference.||||0.172
71851781|NCT01601821|143217938|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED|||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.||||0.978
71851782|NCT00887471|143217939|SUPERIORITY_OR_OTHER|||||||0.59||||||A priori threshold for statistical significance was P\<.05.|Mixed Models Analysis|||The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.||||.590
71851783|NCT00887471|143217939|SUPERIORITY_OR_OTHER|||||||0.022||||||P value for the variances. The a priori threshold for statistical significance was P \< .05.|Mixed Models Analysis|||A mixed linear model was constructed as described above. Variance was estimated separately for each group.||||.022
71851784|NCT00887471|143217940|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.||||1.00
71851785|NCT00442559|143217941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.015|TWO_SIDED|95.0|-0.29|-0.03|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.03|-0.29|0.015
71820138|NCT00654940|143142607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.305||||80.0|-1.21|-0.41|||ANCOVA|||Treatment comparison of pregabalin - placebo: mixed effects analysis of covariance model fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect, and baseline was fitted as two covariates.||-0.41|-1.21|
71820139|NCT00654940|143142608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.493||||80.0|-3.82|2.78|||ANCOVA|||Neuropathic Pain Symptom Inventory treatment comparison: Pregabalin - Placebo. Total score was analyzed using a mixed effect analysis of covariance model based on the full analysis set (FAS), accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||2.78|-3.82|
71820140|NCT00654940|143142609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29000.0|STANDARD_ERROR_OF_MEAN|17000.0||||80.0|6100.0|51000.0|||ANCOVA|||Difference in least squares means Pregabalin-Placebo. Model of day (8 am to 8 pm) total activity score at end of treatment. Mixed effects analysis of covariance model was fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.||51000|6100|
71820141|NCT00619476|143142642|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.81||||0.013|TWO_SIDED|95.0|-1.4|-0.23||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.23|-1.40|0.013
71820142|NCT00619476|143142642|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-0.7||||0.029|TWO_SIDED|95.0|-1.33|-0.07||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.07|-1.33|0.029
71820143|NCT00619476|143142642|SUPERIORITY_OR_OTHER||Adjusted Mean difference versus placebo|-1.07||||0.002|TWO_SIDED|95.0|-1.68|-0.45||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||-0.45|-1.68|0.002
71820144|NCT01811563|143142673|EQUIVALENCE|Main effect for implant independent of time||||||0.661|||||||ANOVA|||||||0.661
71820145|NCT01811563|143142673|EQUIVALENCE|Main effect for time independent of implant|||||<|0.001|||||||ANOVA|||||||<0.001
71820146|NCT01811563|143142673|EQUIVALENCE|Interaction between implant and time||||||0.27|||||||ANOVA|||||||0.270
71820147|NCT01811563|143142674|EQUIVALENCE|Main effect for implant independent of time||||||0.856|||||||ANOVA|Main effect for implant, LQ-YBT Baseline to 52 weeks||||||0.856
71820148|NCT01811563|143142674|EQUIVALENCE|Time independent of implant, Baseline to 52 Weeks|||||<|0.001|||||||ANOVA|||||||<0.001
71820149|NCT01811563|143142674|EQUIVALENCE|Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker||||||0.822|||||||ANOVA|||||||0.822
71820150|NCT01811563|143142675|EQUIVALENCE|Main effect for implant, Baseline to 52 weeks||||||0.158|||||||ANOVA|||||||.158
71820151|NCT01811563|143142675|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
71820152|NCT01811563|143142675|EQUIVALENCE|Interaction of time by implant, Baseline to 52 weeks||||||0.365|||||||ANOVA|||||||0.365
71820153|NCT01811563|143142677|EQUIVALENCE|Main effect for implant, baseline to 52 weeks||||||0.416|||||||ANOVA|||||||.416
71820154|NCT01811563|143142677|EQUIVALENCE|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
71820155|NCT01811563|143142677|EQUIVALENCE|Implant by time interaction, baseline to 52 weeks||||||0.917|||||||ANOVA|||||||0.917
71820156|NCT01811563|143142679|EQUIVALENCE|Main effect by implant, Baseline to 52 weeks||||||0.83|||||||ANOVA|||||||0.830
71820157|NCT01811563|143142679|EQUIVALENCE|Main effect by time, baseline to 52 weeks|||||<|0.001|||||||ANOVA|||||||<0.001
71820158|NCT01811563|143142679|EQUIVALENCE|Interaction between implant and time, baseline to 52 weeks||||||0.728|||||||ANOVA|||||||0.728
71820159|NCT01811563|143142680|EQUIVALENCE|Between implants at 6 weeks||||||0.319|||||||t-test, 2 sided|||||||0.319
71820160|NCT01327547|143142684|SUPERIORITY_OR_OTHER||Difference in proportion|-0.002||||0.4598|TWO_SIDED|95.0|-0.0417|0.0376|||Cochran-Mantel-Haenszel||Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.||0.0376|-0.0417|0.4598
71820161|NCT01327547|143142685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0167|||||TWO_SIDED|95.0|-0.0653|0.0319|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.|||0.0319|-0.0653|
71820162|NCT01327547|143142685|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0177|||||TWO_SIDED|95.0|-0.0805|0.0452|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.|||0.0452|-0.0805|
71902229|NCT04743635|143326186|OTHER|Performance goal. The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6.|Percentage improved|95.6||||0.0001|TWO_SIDED|95.0|87.6|99.1|||t-test, 2 sided|||"The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted (e.g., if improved, worse and much worse, worse was counted). A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3)."||99.1|87.6|.0001
71902230|NCT04743635|143326189|OTHER|Performance goal. In order to meet the endpoint, the lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.|Percentage improved|72.1||||0.0264|TWO_SIDED|95.0|59.9|82.3|||t-test, 2 sided|||||82.3|59.9|.0264
71902231|NCT02592629|143326196|EQUIVALENCE|ANOVA|||||<|0.05|||||||ANOVA|||||||<0.05
71902232|NCT01204658|143326198|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
71902233|NCT01204658|143326198|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
71902234|NCT01204658|143326198|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.62|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.||2.57|-2.62|0.003
71820163|NCT01327547|143142690|SUPERIORITY_OR_OTHER||Difference in proportion|-0.015|||||TWO_SIDED|95.0|-0.1484|0.1185|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.||0.1185|-0.1484|
71820164|NCT01327547|143142690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0255|||||TWO_SIDED|95.0|-0.1784|0.1274|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.||0.1274|-0.1784|
71820165|NCT01327547|143142690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.083|||||TWO_SIDED|95.0|-0.2421|0.0761|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.||0.0761|-0.2421|
71820166|NCT01327547|143142691|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|-41.12||||0.1174|TWO_SIDED|95.0|-92.72|10.49|||ANCOVA||Difference in Least Square (LS) Mean|The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||10.49|-92.72|0.1174
71820167|NCT01327547|143142691|SUPERIORITY_OR_OTHER||Difference in LS Mean|-21.96||||0.593|TWO_SIDED|95.0|-103.05|59.12|||ANCOVA||Difference in LS Mean|The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||59.12|-103.05|0.5930
71851786|NCT00442559|143217941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16||||0.027|TWO_SIDED|95.0|-0.3|-0.02|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.02|-0.3|0.027
71851787|NCT00442559|143217942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.21||||0.006|TWO_SIDED|95.0|-0.36|-0.07|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.07|-0.36|0.006
71820168|NCT01327547|143142691|SUPERIORITY_OR_OTHER||Difference in LS Mean|-48.26||||0.0669|TWO_SIDED|95.0|-99.93|3.41|||ANCOVA|||The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||3.41|-99.93|0.0669
71820169|NCT01327547|143142691|SUPERIORITY_OR_OTHER||Difference in LS Mean|-65.28||||0.1799|TWO_SIDED|95.0|-161.07|30.5|||ANCOVA|||The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||30.50|-161.07|0.1799
71902235|NCT01204658|143326198|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.||2.57|-2.61|0.003
71902236|NCT01204658|143326199|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
71820170|NCT01327547|143142691|SUPERIORITY_OR_OTHER||Difference in LS Mean|-27.71||||0.3859|TWO_SIDED|95.0|-90.71|35.29|||ANCOVA|||The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||35.29|-90.71|0.3859
71820171|NCT01327547|143142691|SUPERIORITY_OR_OTHER||Difference in LS Mean|-31.86||||0.5571|TWO_SIDED|95.0|-138.93|75.21|||ANCOVA|||The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.||75.21|-138.93|0.5571
71820172|NCT01327547|143142692|SUPERIORITY_OR_OTHER||Difference in LS Mean|-56.06||||0.0153|TWO_SIDED|95.0|-101.2|-10.92|||ANCOVA||Difference in LS Mean|The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||-10.92|-101.20|0.0153
71820173|NCT01327547|143142692|SUPERIORITY_OR_OTHER||Difference in LS Mean|-44.93||||0.0947|TWO_SIDED|95.0|-97.72|7.87|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||7.87|-97.72|0.0947
71820174|NCT01327547|143142692|SUPERIORITY_OR_OTHER||Difference in LS Mean|-29.75||||0.3595|TWO_SIDED|95.0|-93.74|34.24|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||34.24|-93.74|0.3595
71820175|NCT01327547|143142693|SUPERIORITY_OR_OTHER||Difference in LS Mean|-2.53||||0.4476|TWO_SIDED|95.0|-9.11|4.05|||ANCOVA||Difference in LS Mean|The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||4.05|-9.11|0.4476
71820176|NCT01327547|143142693|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.67||||0.3012|TWO_SIDED|95.0|-0.61|1.96|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.96|-0.61|0.3012
71820177|NCT01327547|143142693|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.92||||0.4196|TWO_SIDED|95.0|-1.33|3.17|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||3.17|-1.33|0.4196
71820178|NCT01327547|143142694|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.3||||0.9904|TWO_SIDED|95.0|-48.66|49.26||Not specifed.|ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||49.26|-48.66|0.9904
71820179|NCT01327547|143142694|SUPERIORITY_OR_OTHER||Difference in LS Mean|10.87||||0.7697|TWO_SIDED|95.0|-62.44|84.18|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||84.18|-62.44|0.7697
71820180|NCT01327547|143142694|SUPERIORITY_OR_OTHER||Difference in LS Mean|-24.49||||0.5816|TWO_SIDED|95.0|-112.21|63.23|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||63.23|-112.21|0.5816
71820181|NCT01327547|143142695|SUPERIORITY_OR_OTHER||Difference in LS Mean|498.04||||0.3786|TWO_SIDED|95.0|-617.33|1613.41|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1613.41|-617.33|0.3786
71820182|NCT01327547|143142695|SUPERIORITY_OR_OTHER||Difference in LS Mean|348.7||||0.4388|TWO_SIDED|95.0|-539.61|1237.01|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1237.01|-539.61|0.4388
71902237|NCT01204658|143326199|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
71679882|NCT05127304|142877169|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory visits||||0.002
71851788|NCT00442559|143217942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12||||0.032|TWO_SIDED|95.0|-0.24|-0.01|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.||-0.01|-0.24|0.032
71851789|NCT02604199|143217952|SUPERIORITY||LS Mean Difference|-0.086|STANDARD_ERROR_OF_MEAN|0.048||0.081|TWO_SIDED|95.0|-0.183|0.011||Mixed effect model repeat measurement (MMRM) includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|MMRM|Within-subject covariance is unstructured.||||0.011|-0.183|0.0810
71851790|NCT02604199|143217952|SUPERIORITY||LS Mean Difference|-0.309|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.406|-0.212||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.212|-0.406|<.0001
71851791|NCT02604199|143217952|SUPERIORITY||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.322|-0.124||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||||-0.124|-0.322|<.0001
71851792|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.089|STANDARD_ERROR_OF_MEAN|0.046||0.0583|TWO_SIDED|95.0|-0.181|0.003||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.003|-0.181|0.0583
71851793|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.176|STANDARD_ERROR_OF_MEAN|0.045||0.003|TWO_SIDED|95.0|-0.267|-0.085||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||-0.085|-0.267|0.003
71851794|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.087|STANDARD_ERROR_OF_MEAN|0.047||0.067|TWO_SIDED|95.0|-0.181|0.006||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15||0.006|-0.181|0.0670
71902238|NCT01204658|143326199|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.63|2.66||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.||2.66|-2.63|0.003
71902239|NCT01204658|143326199|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value \< 5%.|Difference in percentage|0.0||||0.003|TWO_SIDED|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever \> 40.0°C and causal relationship to vaccination \> the boundary expressed as 5% + 0.5\*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.||2.64|-2.61|0.003
71902240|NCT05513053|143326226|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.98|||||TWO_SIDED|95.0|1.73|2.27||||||Statistical analysis for A/H1N1||2.27|1.73|
71902241|NCT05513053|143326226|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|3.27|||||TWO_SIDED|95.0|2.76|3.87||||||Statistical analysis for A/H3N2||3.87|2.76|
71902242|NCT05513053|143326226|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.57|||||TWO_SIDED|95.0|1.35|1.82||||||Statistical analysis for B/Victoria||1.82|1.35|
71679883|NCT05127304|142877169|OTHER|||||||0.42|||||||Weighted clustered linear regression|||Office visits||||0.420
71679884|NCT05127304|142877169|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Outpatient visits||||0.002
71851795|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0875|TWO_SIDED|95.0|-0.151|0.011||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||0.011|-0.151|0.0875
71851796|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.179|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.259|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.100|-0.259|<.0001
71851797|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0099|TWO_SIDED|95.0|-0.191|-0.027||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29||-0.027|-0.191|0.0099
71851798|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.143|STANDARD_ERROR_OF_MEAN|0.043||0.0017|TWO_SIDED|95.0|-0.229|-0.057||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.057|-0.229|0.0017
71851799|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.265|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|-0.349|-0.18||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.180|-0.349|<.0001
71851800|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.122|STANDARD_ERROR_OF_MEAN|0.043||0.0072|TWO_SIDED|95.0|-0.209|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43||-0.035|-0.209|0.0072
71851801|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.118|STANDARD_ERROR_OF_MEAN|0.039||0.0043|TWO_SIDED|95.0|-0.197|-0.039||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.039|-0.197|0.0043
71851802|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.298|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.376|-0.221||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.221|-0.376|< 0.0001
71851803|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.181|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|-0.261|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57||-0.100|-0.261|<.0001
71851804|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.048||0.0084|TWO_SIDED|95.0|-0.228|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.035|-0.228|0.0084
71851805|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.338|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.433|-0.243||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.243|-0.433|<.0001
71851806|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.206|STANDARD_ERROR_OF_MEAN|0.049||0.0001|TWO_SIDED|95.0|-0.304|-0.108||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71||-0.108|-0.304|0.0001
71902243|NCT05513053|143326226|NON_INFERIORITY|Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was \> 0.667 for each strain.|GMT Ratio|1.22|||||TWO_SIDED|95.0|1.09|1.37||||||Statistical analysis for B/Yamagata||1.37|1.09|
71902244|NCT05513053|143326227|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|1.92|||||TWO_SIDED|95.0|-2.78|6.62||||||Statistical analysis for A/H1N1||6.62|-2.78|
71902245|NCT05513053|143326227|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|-0.59|||||TWO_SIDED|95.0|-4.41|3.23||||||Statistical analysis for A/H3N2||3.23|-4.41|
71902246|NCT05513053|143326227|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|3.29|||||TWO_SIDED|95.0|-1.57|8.14||||||Statistical analysis for B/Victoria||8.14|-1.57|
71902247|NCT05513053|143326227|NON_INFERIORITY|Non-inferiority for seroconversion rates was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for the 4 strains.|Percent Difference|14.3|||||TWO_SIDED|95.0|9.17|19.3||||||Statistical analysis for B/Yamagata||19.3|9.17|
71902248|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with atorvastatin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.30
71902249|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with sulindac compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.60
71679885|NCT05127304|142877169|OTHER|||||||0.304|||||||Weighted clustered linear regression|||Emergency room visits||||0.304
71820183|NCT01327547|143142695|SUPERIORITY_OR_OTHER||Difference in LS Mean|-173.57||||0.8559|TWO_SIDED|95.0|-2060.81|1713.68|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1713.68|-2060.81|0.8559
71820184|NCT01327547|143142696|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.03||||0.8024|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.28|-0.22|0.8024
71820185|NCT01327547|143142696|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.266|TWO_SIDED|95.0|-0.12|0.43|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.43|-0.12|0.2660
71820186|NCT01327547|143142696|SUPERIORITY_OR_OTHER||Difference in LS mean|0.15||||0.2855|TWO_SIDED|95.0|-0.12|0.41|||ANCOVA||Difference in LS mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.41|-0.12|0.2855
71820187|NCT01327547|143142697|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.15||||0.7778|TWO_SIDED|95.0|-0.93|1.23|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.23|-0.93|0.7778
71820188|NCT01327547|143142697|SUPERIORITY_OR_OTHER||Difference in LS mean|0.0||||0.9991|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.10|-0.10|0.9991
71820189|NCT01327547|143142697|SUPERIORITY_OR_OTHER||Difference in LS mean|-0.02||||0.7275|TWO_SIDED|95.0|-0.16|0.11|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.11|-0.16|0.7275
71820190|NCT01327547|143142698|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.07||||0.5201|TWO_SIDED|95.0|-0.15|0.3|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.30|-0.15|0.5201
71820191|NCT01327547|143142698|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.08||||0.4657|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|||Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.13|-0.28|0.4657
71820192|NCT01327547|143142698|SUPERIORITY_OR_OTHER||Difference in LS Mean|-0.03||||0.8087|TWO_SIDED|95.0|-0.25|0.2|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.20|-0.25|0.8087
71851807|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.096|STANDARD_ERROR_OF_MEAN|0.05||0.0589|TWO_SIDED|95.0|-0.195|0.004||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||0.004|-0.195|0.0589
71851808|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.335|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|-0.433|-0.236||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.236|-0.433|<.0001
71679886|NCT05127304|142877169|OTHER|||||||0.326|||||||Weighted clustered linear regression|||Inpatient visits||||0.326
71820193|NCT01327547|143142699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.84||||0.1417|TWO_SIDED|95.0|-4.31|0.63|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.63|-4.31|0.1417
71820194|NCT01327547|143142699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.44||||0.2679|TWO_SIDED|95.0|-4.01|1.14|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||1.14|-4.01|0.2679
71820195|NCT01327547|143142699|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.48||||0.1366|TWO_SIDED|95.0|-3.45|0.49|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.||0.49|-3.45|0.1366
71820196|NCT02291289|143142712|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.872|TWO_SIDED|95.0|0.5|1.82|||Log Rank|||||1.82|0.50|= 0.872
71820197|NCT02291289|143142712|SUPERIORITY||Hazard Ratio (HR)|0.95|||=|0.666|TWO_SIDED|95.0|0.77|1.18|||Log Rank|||||1.18|0.77|= 0.666
71820198|NCT02291289|143142712|SUPERIORITY||Hazard Ratio (HR)|1.44|||=|0.128|TWO_SIDED|95.0|0.9|2.29|||Log Rank|||||2.29|0.90|= 0.128
71820199|NCT02291289|143142713|SUPERIORITY||Hazard Ratio (HR)|0.71|||=|0.276|TWO_SIDED|95.0|0.39|1.32|||Log Rank|||||1.32|0.39|= 0.276
71820200|NCT02291289|143142713|SUPERIORITY||Hazard Ratio (HR)|0.81|||=|0.076|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||||1.02|0.64|= 0.076
71679887|NCT05127304|142877169|OTHER|||||||0.007|||||||Weighted clustered linear regression|||Other medical visits||||0.007
71679888|NCT05127304|142877170|OTHER|||||||0.52|||||||Weighted clustered linear regression|||||||0.520
71820201|NCT02291289|143142713|SUPERIORITY||||||=|0.157|||||||Log Rank|||||||= 0.157
71820202|NCT02291289|143142713|SUPERIORITY||Hazard Ratio (HR)|1.25|||=|0.415|TWO_SIDED|95.0|0.73|2.14|||Log Rank|||||2.14|0.73|= 0.415
71820203|NCT02291289|143142715|SUPERIORITY||||||=|0.064|||||||Chi-squared|||||||= 0.064
71820204|NCT02291289|143142715|SUPERIORITY||||||=|0.658|||||||Chi-squared|||||||= 0.658
71820205|NCT02291289|143142715|SUPERIORITY|||||||0.093|||||||Chi-squared|||||||0.093
71820206|NCT02291289|143142716|SUPERIORITY||||||=|0.125|||||||Chi-squared|||||||= 0.125
71820207|NCT02291289|143142716|SUPERIORITY||||||=|0.739|||||||Chi-squared|||||||= 0.739
71851809|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.239|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.34|-0.137||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85||-0.137|-0.340|<.0001
71851810|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.132|STANDARD_ERROR_OF_MEAN|0.052||0.0138|TWO_SIDED|95.0|-0.236|-0.028||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.028|-0.236|0.0138
71851811|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.355|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.458|-0.252||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.252|-0.458|<.0001
71851812|NCT02604199|143217953|SUPERIORITY||LS Mean|-0.223|STANDARD_ERROR_OF_MEAN|0.053||0.0001|TWO_SIDED|95.0|-0.329|-0.117||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99||-0.117|-0.329|0.0001
71820208|NCT02291289|143142716|SUPERIORITY|||||||0.362|||||||Chi-squared|||||||0.362
71820209|NCT02291289|143142718|SUPERIORITY||||||=|0.421|||||||Log Rank|||||||= 0.421
71820210|NCT02291289|143142718|SUPERIORITY||||||=|0.495|||||||Log Rank|||||||= 0.495
71820211|NCT02291289|143142718|SUPERIORITY|||||||0.357|||||||Log Rank|||||||0.357
71820212|NCT02802020|143142731|SUPERIORITY|||||||0.999|||||||Fisher Exact|||"We hypothesized that pain reduction (as defined in Study endpoints above) would be achieved in a performance goal of at least 53% of patients receiving the study SEMS. Assuming an observed pain reduction rate of 75% and using an exact test with a one-sided alpha of 0.025, 43 patients were required to obtain power of at least 80%."||||0.999
71820213|NCT02802020|143142732|SUPERIORITY|we hypothesized that the proportion of patients reporting one or more related SAE(s) would be below a performance goal of 32%. Assuming an observed SAE rate of 15% and using an exact test with one-sided alpha of 0.025, 57 patients were required to obtain power of at least 80%.||||||0.513|||||||Fisher Exact|||||||0.513
71820214|NCT00506285|143142738|NON_INFERIORITY_OR_EQUIVALENCE|F(1,47)=26.7, p=.001||||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|F(1,47)=26.7, p=.001||||||.001
71851813|NCT05878522|143218016|OTHER||LS Mean difference|11.73|||||TWO_SIDED|90.0|8.89|14.58||||||3- hours post-dose||14.58|8.89|
71679889|NCT05127304|142877171|OTHER|||||||0.037|||||||Weighted clustered linear regression|||||||0.037
71679890|NCT05127304|142877172|OTHER|||||||0.06|||||||Weighted clustered linear regression|||Medical costs||||0.060
71679891|NCT05127304|142877172|OTHER|||||||0.177|||||||Weighted clustered linear regression|||Ambulatory costs||||0.177
71820215|NCT00506285|143142739|NON_INFERIORITY_OR_EQUIVALENCE|mixed models analysis||||||0.001|TWO_SIDED|95.0||||F(1,47)=24.8, p=.001|Mixed Models Analysis|||||||.001
71820216|NCT01089556|143142740|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.192||||0.37||95.0|||||Mixed Models Analysis|||||||0.370
71820217|NCT01089556|143142741|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.614|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71820218|NCT01089556|143142742|SUPERIORITY_OR_OTHER||LS Mean Differences (Final Values)|-0.003||||0.991||95.0|||||Mixed Models Analysis|||||||0.991
71820219|NCT01089556|143142743|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.431|||<|0.001|TWO_SIDED|95.0|1.233|1.662|||Cochran-Mantel-Haenszel|||||1.662|1.233|<0.001
71820220|NCT01089556|143142744|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.052||||0.565|TWO_SIDED|95.0|0.884|1.253|||Cochran-Mantel-Haenszel|||||1.253|0.884|0.565
71820221|NCT01089556|143142745|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.467|||<|0.001|TWO_SIDED|95.0|1.214|1.771|||Cochran-Mantel-Haenszel|||||1.771|1.214|<0.001
71679892|NCT05127304|142877172|OTHER|||||||0.834|||||||Weighted clustered linear regression|||Office visits costs||||0.834
71820222|NCT01089556|143142746|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.233||||0.068|TWO_SIDED|95.0|0.98|1.55|||Cochran-Mantel-Haenszel|||||1.550|0.980|0.068
71820223|NCT01089556|143142747|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.279|||<|0.001|TWO_SIDED|95.0|1.125|1.456|||Cochran-Mantel-Haenszel|||||1.456|1.125|<0.001
71820224|NCT01089556|143142748|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.985||||0.843|TWO_SIDED|95.0|0.842|1.151|||Cochran-Mantel-Haenszel|||||1.151|0.842|0.843
71820225|NCT01089556|143142749|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.341|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71820226|NCT01089556|143142750|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.073||||0.475||95.0|||||Mixed Models Analysis|||||||0.475
71820227|NCT01089556|143142751|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-4.758|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71820228|NCT01089556|143142752|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.933||||0.289||95.0|||||Mixed Models Analysis|||||||0.289
71820229|NCT01089556|143142753|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.02||||0.071||95.0|||||ANCOVA|||||||0.071
71820230|NCT01089556|143142754|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.193||||0.78||95.0|||||ANCOVA|||||||0.780
71820231|NCT01089556|143142755|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.558||||0.008||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.008
71820232|NCT01089556|143142755|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.423||||0.031||95.0||||p-value is for depression subscale score.|Mixed Models Analysis|||||||0.031
71820233|NCT01089556|143142756|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.615||||0.049||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis|||||||0.049
71679893|NCT05127304|142877172|OTHER|||||||0.121|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.121
71820234|NCT01089556|143142756|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.378||||0.198||95.0||||P-value is for depression subscale score.|Mixed Models Analysis|||||||0.198
71820235|NCT01089556|143142761|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.343|||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71820236|NCT01089556|143142762|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.095||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
71820237|NCT01089556|143142763|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-2.02||||0.064||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.064
71820238|NCT01089556|143142763|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|0.135||||0.843||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.843
71820239|NCT01089556|143142764|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-1.329||||0.354||95.0||||P-value is for systolic BP.|ANCOVA|||||||0.354
71820240|NCT01089556|143142764|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.003||||0.997||95.0||||P-value is for diastolic BP.|ANCOVA|||||||0.997
71820241|NCT01089556|143142765|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|3.317|||<|0.001||95.0|||||ANCOVA|||||||<0.001
71820242|NCT01089556|143142766|SUPERIORITY_OR_OTHER||LS Mean Difference (Final Values)|-0.942||||0.332||95.0|||||ANCOVA|||||||0.332
71820243|NCT01089556|143142767|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Fisher Exact|||||||0.618
71679894|NCT05127304|142877172|OTHER|||||||0.159|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.159
71820244|NCT01089556|143142768|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Fisher Exact|||||||0.571
71820245|NCT01089556|143142769|SUPERIORITY_OR_OTHER|||||||0.744||95.0|||||Fisher Exact|||||||0.744
71820246|NCT01089556|143142770|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.000
71820247|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|Mixed Model for Repeated Measures (MMRM)|||||||<0.0001
71679895|NCT05127304|142877172|OTHER|||||||0.289|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.289
71679896|NCT05127304|142877172|OTHER|||||||0.055|||||||Weighted clustered linear regression|||Other medical costs||||0.055
71679897|NCT05127304|142877172|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71820248|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
71820249|NCT03748979|143142821|SUPERIORITY|||||||0.0002||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||0.0002
71820250|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
71820251|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
71820252|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 1.|MMRM|||||||<0.0001
71820253|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
71820254|NCT03748979|143142821|SUPERIORITY||||||<|0.0001||||||P-value was obtained using MMRM analysis. The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group on Day 7.|MMRM|||||||<0.0001
71820255|NCT03230864|143142844|SUPERIORITY||Mean Difference (Final Values)|5.47||||0.0809|TWO_SIDED|95.0|-0.7|11.65|||Mixed Model Repeated Measures|||The mean changes from randomization in PANNS total score was analysed using a mixed model for repeated measures (MMRM) approach. The model will include the fixed, categorical effects of treatment, strata, visit, treatment-by-visit interaction, fixed covariates of baseline scores and baseline scores-by-visit interaction. An unstructured (co)variance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.||11.65|-0.70|0.0809
71851814|NCT05878522|143218016|OTHER||LS Mean difference|11.35|||||TWO_SIDED|90.0|8.5|14.2||||||4-hours post-dose||14.20|8.50|
71851815|NCT05878522|143218016|OTHER||LS Mean difference|8.35||||||90.0|5.51|11.2||||||5-hours post-dose||11.20|5.51|
71902250|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.92||95.0||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with oligofructose-enriched inulin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.||||0.92
71851816|NCT02252172|143218017|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.43|0.73|||Log Rank|||||0.73|0.43|<0.0001
71851817|NCT03163472|143218063|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71851818|NCT03163472|143218064|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71851819|NCT03163472|143218065|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
71851820|NCT03163472|143218066|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71851821|NCT03000829|143218121|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71851822|NCT03000829|143218122|SUPERIORITY|||||||0.86|||||||t-test, 2 sided|||||||0.86
71851823|NCT03000829|143218123|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71902251|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.59
71679898|NCT05127304|142877172|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71902252|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.12
71679899|NCT05127304|142877173|OTHER|||||||0.066|||||||Weighted clustered linear regression|||Medical costs||||0.066
71851824|NCT03000829|143218124|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71851825|NCT03000829|143218125|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|||||||0.63
71851826|NCT03000829|143218126|SUPERIORITY|||||||0.62|||||||t-test, 2 sided|||||||0.62
71851827|NCT03000829|143218127|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71851828|NCT03000829|143218128|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.40
71851829|NCT03000829|143218131|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
71851830|NCT04448561|143218152|OTHER||Geometric Least square (LS) mean ratio|100.64|||||TWO_SIDED|90.0|98.37|102.96|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||102.96|98.37|
71851831|NCT04448561|143218153|OTHER||Geometric LS mean ratio|94.28|||||TWO_SIDED|90.0|89.29|99.54|||||Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.|||99.54|89.29|
71851832|NCT04448561|143218155|OTHER||Geometric LS mean ratio|100.79|||||TWO_SIDED|90.0|83.35|121.88|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||121.88|83.35|
71851833|NCT04448561|143218156|OTHER||Geometric LS mean ratio|100.58|||||TWO_SIDED|90.0|81.35|124.36|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||124.36|81.35|
71851834|NCT04448561|143218158|OTHER||Geometric LS mean ratio|89.08|||||TWO_SIDED|90.0|79.58|99.71|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||99.71|79.58|
71851835|NCT04448561|143218159|OTHER||Geometric LS mean ratio|96.11|||||TWO_SIDED|90.0|83.03|111.25|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||111.25|83.03|
71851836|NCT04448561|143218161|OTHER||Geometric LS mean ratio|86.54|||||TWO_SIDED|90.0|76.01|98.52|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.|||98.52|76.01|
71851837|NCT04448561|143218162|OTHER||Geometric LS mean ratio|95.1|||||TWO_SIDED|90.0|82.52|109.6|||||Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.|||109.60|82.52|
71851838|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.0011|TWO_SIDED|||||p-values of \<0.05 are considered significant.|Wilcoxon Signed Rank Test|||Physical Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0011
71851839|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.1152|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Physical Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.1152
71851840|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.0552|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Role Limitations due to Emotional Problems: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0552
71851841|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.039|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Energy/Fatigue: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.039
71902253|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.54
71902254|NCT00335504|143326269|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.||||0.41
71902255|NCT00335504|143326270|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between atorvastatin and placebo.||||0.37
71902256|NCT00335504|143326270|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between sulindac and placebo.||||1.00
71902257|NCT00335504|143326270|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between oligofructose-enriched inulin and placebo.||||0.58
71902258|NCT00335504|143326271|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between atorvastatin calcium and placebo.||||0.26
71902259|NCT00335504|143326271|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between sulindac and placebo.||||0.88
71902260|NCT00335504|143326271|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between oligofructose-enriched inulin and placebo.||||0.38
71902261|NCT01405313|143326322|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|2.5||||0.022|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.022
71902262|NCT01405313|143326323|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority|Mean Difference (Final Values)|3.0||||0.016|TWO_SIDED|80.0|||||t-test, 1 sided|||||||0.016
71902263|NCT03456713|143326324|OTHER||Ratio of geometric least squares mean|1.47|||||TWO_SIDED|90.0|1.12|1.94||||||||1.94|1.12|
71902264|NCT03456713|143326325|OTHER||Ratio of geometric least squares mean|1.44|||||TWO_SIDED|90.0|1.15|1.81||||||||1.81|1.15|
71902265|NCT03456713|143326326|OTHER||Ratio of geometric least squares mean|1.66|||||TWO_SIDED|90.0|1.31|2.11||||||||2.11|1.31|
71902266|NCT03456713|143326327|SUPERIORITY||Ratio of Geometric Least Squares Means|0.73|||||TWO_SIDED|90.0|0.43|1.23||||||||1.23|0.43|
71902267|NCT03456713|143326328|OTHER||Ratio of geometric least squares mean|0.98|||||TWO_SIDED|90.0|0.58|1.67||||||||1.67|0.58|
71902268|NCT03456713|143326329|OTHER||Ratio of geometric least squares mean|0.7|||||TWO_SIDED|90.0|0.41|1.2||||||||1.20|0.41|
71902269|NCT01533935|143326377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.215|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.315|0.215|<0.0001
71902270|NCT01533935|143326377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.025||0.0015|TWO_SIDED|95.0|0.031|0.129|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.129|0.031|0.0015
71902271|NCT01533935|143326377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.025||0.0005|TWO_SIDED|95.0|0.039|0.137|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.137|0.039|0.0005
71679900|NCT05127304|142877173|OTHER|||||||0.193|||||||Weighted clustered linear regression|||Ambulatory costs||||0.193
71679901|NCT05127304|142877173|OTHER|||||||0.117|||||||Weighted clustered linear regression|||Office visits costs||||0.117
71679902|NCT05127304|142877173|OTHER|||||||0.25|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.250
71902272|NCT01533935|143326377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.224|0.324|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.324|0.224|<0.0001
71902273|NCT01533935|143326377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|0.039|0.138|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.138|0.039|0.0004
71902274|NCT01533935|143326377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.047|0.147|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.147|0.047|0.0001
71902275|NCT01533935|143326378|SUPERIORITY_OR_OTHER||Ratio|1.134|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|1.065|1.206|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD|||1.206|1.065|<0.0001
71902276|NCT01533935|143326378|SUPERIORITY_OR_OTHER||Ratio|1.111|STANDARD_ERROR_OF_MEAN|0.035||0.0009|TWO_SIDED|95.0|1.045|1.182|||Mixed Models Analysis||Ratio calculated Tiotropium + olodaterol 5/5 QD as divided by Olodaterol 5 mcg QD|||1.182|1.045|0.0009
71902277|NCT01533935|143326378|SUPERIORITY_OR_OTHER||Ratio|1.043|STANDARD_ERROR_OF_MEAN|0.033||0.1807|TWO_SIDED|95.0|0.981|1.109|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD|||1.109|0.981|0.1807
71902278|NCT01533935|143326378|SUPERIORITY_OR_OTHER||Ratio|1.121|STANDARD_ERROR_OF_MEAN|0.036||0.0003|TWO_SIDED|95.0|1.054|1.193|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD|||1.193|1.054|0.0003
71902279|NCT01533935|143326378|SUPERIORITY_OR_OTHER||Ratio|1.099|STANDARD_ERROR_OF_MEAN|0.035||0.0029|TWO_SIDED|95.0|1.033|1.17|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD|||1.170|1.033|0.0029
71902280|NCT01533935|143326378|SUPERIORITY_OR_OTHER||Ratio|1.032|STANDARD_ERROR_OF_MEAN|0.033||0.324|TWO_SIDED|95.0|0.97|1.098|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD|||1.098|0.970|0.3240
71902281|NCT01533935|143326379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.004|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||-0.002|-0.004|<0.0001
71902282|NCT01533935|143326379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.0033|TWO_SIDED|95.0|-0.003|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.003|0.0033
71902283|NCT01533935|143326379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.2306|TWO_SIDED|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.001|-0.002|0.2306
71820256|NCT01744496|143142860|SUPERIORITY_OR_OTHER||Least Square Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.55||0.172|TWO_SIDED|95.0|-1.87|0.34|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.34|-1.87|0.172
71820257|NCT01744496|143142862|SUPERIORITY_OR_OTHER||Least Square Mean|-8.01|STANDARD_ERROR_OF_MEAN|3.77||0.038|TWO_SIDED|95.0|-15.56|-0.46|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||-0.46|-15.56|0.038
71851842|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.0223|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Emotional Well Being: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0223
71851843|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.4664|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Social Functioning: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.4664
71851844|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.0001|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||Pain: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0001
71851845|NCT03694210|143218251|SUPERIORITY||Mean Difference (Net)|0.0||||0.0639|TWO_SIDED|||||p-values of \<0.05 are considered significant|Wilcoxon Signed Rank Test|||General Health: 21 Day Post Necrosectomy SF-36v1 Score is compared to Baseline score for improvement.||||0.0639
71820258|NCT01744496|143142863|SUPERIORITY_OR_OTHER||Least Square Mean|-1.02|STANDARD_ERROR_OF_MEAN|0.87||0.247|TWO_SIDED|95.0|-2.76|0.73|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.73|-2.76|0.247
71820259|NCT01744496|143142864|SUPERIORITY_OR_OTHER||Least Square Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.64||0.371|TWO_SIDED|95.0|-1.85|0.7|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||0.70|-1.85|0.371
71851846|NCT01375777|143218253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.23|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-54.52|-39.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-39.93|-54.52|<0.001
71851847|NCT01375777|143218253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.17|STANDARD_ERROR_OF_MEAN|3.66|<|0.001||95.0|-47.38|-32.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-32.95|-47.38|<0.001
71851848|NCT01375777|143218253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.27|STANDARD_ERROR_OF_MEAN|3.68|<|0.001|TWO_SIDED|95.0|-44.53|-30.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-30.02|-44.53|<0.001
71851849|NCT01375777|143218253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.53|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-59.67|-45.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-45.38|-59.67|<0.001
71902284|NCT01533935|143326379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.001|<|0.0001|TWO_SIDED|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||-0.002|-0.005|<0.0001
71902285|NCT01533935|143326379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.001||0.001|TWO_SIDED|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||-0.001|-0.004|0.0010
71902286|NCT01533935|143326379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.001||0.1206|TWO_SIDED|95.0|-0.002|0.0|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.000|-0.002|0.1206
71902287|NCT01533935|143326380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.329|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.294|0.364|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD|||0.364|0.294|<0.0001
71902288|NCT01533935|143326380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.099|0.169|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD|||0.169|0.099|<0.0001
71902289|NCT01533935|143326380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.1|0.17|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD|||0.170|0.100|<0.0001
71902290|NCT01533935|143326380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.305|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.269|0.34|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD|||0.340|0.269|<0.0001
71902291|NCT01533935|143326380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.075|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD|||0.145|0.075|<0.0001
71902292|NCT01533935|143326380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.076|0.146|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD|||0.146|0.076|<0.0001
71679903|NCT05127304|142877173|OTHER|||||||0.431|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.431
71902293|NCT00681538|143326381|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.84||||0.0002|TWO_SIDED|95.0|-1.29|-0.4|||ANCOVA|||||-0.40|-1.29|0.0002
71902294|NCT00681538|143326382|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.731||||0.0003|TWO_SIDED|95.0|1.589|4.694|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|30% responders||4.694|1.589|0.0003
71902295|NCT00681538|143326382|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.647||||0.0612|TWO_SIDED|95.0|0.977|2.777|||Regression, Logistic||Odds ratio\>1 indicates an improvement in favour of Sativex|50% Responders||2.777|0.977|0.0612
71902296|NCT00681538|143326383|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-2.53||||0.0046|TWO_SIDED|95.0|-4.27|-0.79|||ANCOVA||A negative difference indicates an improvement in spasm frequency in favour of Sativex.|||-0.79|-4.27|0.0046
71902297|NCT00681538|143326384|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.25|-0.51|||ANCOVA||A negative difference indicates an improvement in sleep disruption in favour of Sativex.|||-0.51|-1.25|<0.0001
71902298|NCT00681538|143326385|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-1.75||||0.0939|TWO_SIDED|95.0|-3.8|0.3|||ANCOVA||A negative difference indicates an improvement in spasticity in favour of Sativex.|||0.30|-3.80|0.0939
71902299|NCT00681538|143326386|SUPERIORITY_OR_OTHER_LEGACY||treatment difference|-2.85||||0.56|TWO_SIDED|95.0|-12.75|7.04|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For Arm||7.04|-12.75|0.56
71902300|NCT00681538|143326386|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.04||||0.98|TWO_SIDED|95.0|-2.56|2.64|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For leg||2.64|-2.56|0.98
71902301|NCT00681538|143326387|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-3.34||||0.0687|TWO_SIDED|95.0|-6.95|0.26|||ANCOVA||A negative treatment difference indicates an improvement in favour of Sativex.|||0.26|-6.95|0.0687
71902302|NCT00681538|143326388|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.703||||0.0234|TWO_SIDED|95.0|1.075|2.698|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||2.698|1.075|0.0234
71902303|NCT00681538|143326389|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4||||0.0053|TWO_SIDED|95.0|1.297|4.443|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||4.443|1.297|0.0053
71902304|NCT00681538|143326390|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.792||||0.0613|TWO_SIDED|95.0|0.973|3.301|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.301|0.973|0.0613
71902305|NCT00681538|143326391|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.958||||0.0045|TWO_SIDED|95.0|1.232|3.112|||Regression, Logistic||An odds ratio \> 1 indicates an improvement in favour of Sativex.|||3.112|1.232|0.0045
71902306|NCT00681538|143326392|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|0.02||||0.2836|TWO_SIDED|95.0|-0.02|0.07|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|For Health State Index||0.07|-0.02|0.2836
71902307|NCT00681538|143326392|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|1.24||||0.5644|TWO_SIDED|95.0|-3.01|5.5|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|Health Status VAS||5.50|-3.01|0.5644
71679904|NCT05127304|142877173|OTHER|||||||0.129|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.129
71902308|NCT00681538|143326393|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-0.06||||0.9369|TWO_SIDED|95.0|-1.62|1.49|||ANCOVA||A negative difference indicates an improvement in depression in favour of Sativex.|||1.49|-1.62|0.9369
71902309|NCT00630812|143326394|SUPERIORITY||Mean Difference (Net)|54.14||||0.059|TWO_SIDED|95.0|-1.97|110.26|||Mixed Models Analysis|||||110.26|-1.97|0.059
71902310|NCT00630812|143326394|SUPERIORITY||Odds Ratio (OR)|1.69||||0.041|TWO_SIDED|95.0|1.02|2.8||Response defined as change of \>=100mL at week 26|Regression, Logistic|45.7% response on Mannitol 400mg, 35.5% on Control||||2.80|1.02|0.041
71679905|NCT05127304|142877173|OTHER|||||||0.236|||||||Weighted clustered linear regression|||Other medical costs||||0.236
71679906|NCT05127304|142877173|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71679907|NCT05127304|142877173|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71851850|NCT01375777|143218253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-54.89|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-40.60|-54.89|<0.001
71902311|NCT00630812|143326395|SUPERIORITY||Mean Difference (Net)|43.49||||0.177|TWO_SIDED|95.0|-19.8|106.78|||Mixed Models Analysis|||||106.78|-19.8|0.177
71902312|NCT00630812|143326396|SUPERIORITY||Rate ratio|0.85||||0.52|TWO_SIDED|95.0|0.51|1.41|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.41|0.51|0.520
71902313|NCT00630812|143326397|SUPERIORITY||Rate ratio|0.75||||0.328|TWO_SIDED|95.0|0.42|1.33|||Poisson regression|Offset of the natural logarithm of follow-up time||||1.33|0.42|0.328
71902314|NCT00630812|143326398|SUPERIORITY||Rate ratio|0.89||||0.368|TWO_SIDED|95.0|0.69|1.15|||Poisson regression|||||1.15|0.69|0.368
71902315|NCT00630812|143326399|SUPERIORITY||Mean Difference (Net)|2.42||||0.024|TWO_SIDED|95.0|0.33|4.51|||ANCOVA|||||4.51|0.33|0.024
71851851|NCT01375777|143218253|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.57|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-50.71|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.42|-50.71|<0.001
71851852|NCT01375777|143218254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.9|STANDARD_ERROR_OF_MEAN|5.2|<|0.001|TWO_SIDED|95.0|-76.3|-55.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-55.6|-76.3|<0.001
71851853|NCT01375777|143218254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001||95.0|-73.2|-52.2||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-52.2|-73.2|<0.001
71851854|NCT01375777|143218254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.3|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-62.7|-41.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-41.9|-62.7|<0.001
71902316|NCT00630812|143326400|SUPERIORITY||Mean Difference (Net)|71.35||||0.022|TWO_SIDED|95.0|10.57|132.13|||Mixed Models Analysis|||||132.13|10.57|0.022
71902317|NCT00630812|143326401|SUPERIORITY||Mean Difference (Net)|34.34||||0.49|TWO_SIDED|95.0|-63.47|132.14|||Mixed Models Analysis|||||132.14|-63.47|0.49
71902318|NCT00630812|143326402|SUPERIORITY|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||||||0.042
71902319|NCT00316303|143326408|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
71902320|NCT00316303|143326409|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
71902321|NCT00316303|143326410|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wald Chi-squared|||||||<0.001
71902322|NCT00316303|143326411|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wald Chi-squared|||||||0.011
71902323|NCT00316303|143326412|SUPERIORITY_OR_OTHER|||||||0.6|||||||Chi-squared|||||||0.6
71902324|NCT01753076|143326422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.0||||0.12|TWO_SIDED|95.0|-67.9|7.9|||ANCOVA||A negative mean difference means that the direction of effect is in favor of placebo.|||7.9|-67.9|0.120
71902325|NCT01753076|143326423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.139|TWO_SIDED|95.0|-3.1|0.4|||Mixed Models Analysis|||||0.4|-3.1|0.139
71902326|NCT01753076|143326424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.173|TWO_SIDED|95.0|-0.3|0.05|||Random coefficients analysis|||||0.05|-0.30|0.173
71902327|NCT01753076|143326425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.127||||0.265|TWO_SIDED|95.0|-0.351|0.097|||Mixed Models Analysis|||||0.097|-0.351|0.265
71902328|NCT01753076|143326426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.125|TWO_SIDED|95.0|-18.7|2.3|||Mixed Models Analysis|||||2.3|-18.7|0.125
71902329|NCT01753076|143326427|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.393|TWO_SIDED|95.0|0.36|1.49|||Regression, Logistic|||||1.49|0.36|0.393
71902330|NCT01753076|143326428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.986|TWO_SIDED|95.0|0.34|2.89|||Regression, Cox||Week 48|||2.89|0.34|0.986
71902331|NCT01753076|143326428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.923|TWO_SIDED|95.0|0.53|2.01|||Chi-squared||Week 60|||2.01|0.53|0.923
71902332|NCT01753076|143326429|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.642|TWO_SIDED|95.0|0.81|1.42|||Regression, Cox|||||1.42|0.81|0.642
71902333|NCT01753076|143326430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|||||TWO_SIDED|95.0|-0.062|0.053||||||||0.053|-0.062|
71902334|NCT01753076|143326431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-2.8|5.5||||||||5.5|-2.8|
71902335|NCT01253044|143326472|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||MMRM|||||||.912
71902336|NCT01253044|143326473|SUPERIORITY_OR_OTHER|||||||0.273|TWO_SIDED||||||MMRM|||||||.273
71902337|NCT00905307|143326474|SUPERIORITY_OR_OTHER||Treatment difference|-4.7||||0.2846|TWO_SIDED|95.0|-10.2|0.82||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.82|-10.2|0.2846
71902338|NCT00905307|143326474|SUPERIORITY_OR_OTHER||Treatment difference|-1.44||||0.6066|TWO_SIDED|95.0|-6.96|4.07||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||4.07|-6.96|0.6066
71679908|NCT05127304|142877174|OTHER|||||||0.057|||||||Weighted clustered linear regression|||Medical costs||||0.057
71820260|NCT01744496|143142865|SUPERIORITY_OR_OTHER||Least Square Mean|-2.82|STANDARD_ERROR_OF_MEAN|2.97||0.346|TWO_SIDED|95.0|-8.76|3.13|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.||||3.13|-8.76|0.346
71820261|NCT01567163|143142868|SUPERIORITY_OR_OTHER||Ratio geometric least squares (LS) means|0.97|||||TWO_SIDED|90.0|0.84|1.1|||Mixed Models Analysis||The ratio of geometric LS means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of geometric LS means is AUC(0-∞) of Cycle 2/Cycle 1.|||1.10|0.84|
71851855|NCT01375777|143218254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-72.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-82.2|-62.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-62.4|-82.2|<0.001
71851856|NCT01375777|143218254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-63.9|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-73.9|-54.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-54.0|-73.9|<0.001
71851857|NCT01375777|143218254|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-70.7|-50.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-50.9|-70.7|<0.001
71851858|NCT01375777|143218255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.15|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.72|-38.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.58|-51.72|<0.001
71851859|NCT01375777|143218255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.79|STANDARD_ERROR_OF_MEAN|3.29|<|0.001||95.0|-43.29|-30.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.29|-43.29|<0.001
71851860|NCT01375777|143218255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.06|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-41.59|-28.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.52|-41.59|<0.001
71851861|NCT01375777|143218255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.11|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-53.33|-40.89||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-40.89|-53.33|<0.001
71902339|NCT00905307|143326474|SUPERIORITY_OR_OTHER||Treatment difference|-3.86||||0.3293|TWO_SIDED|95.0|-9.32|1.59||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.59|-9.32|0.3293
71902340|NCT00905307|143326474|SUPERIORITY_OR_OTHER||Treatment difference|4.62||||0.2263|TWO_SIDED|95.0|-2.89|12.12|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||12.12|-2.89|0.2263
71851862|NCT01375777|143218255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.89|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-48.11|-35.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-35.67|-48.11|<0.001
71902341|NCT00905307|143326474|SUPERIORITY_OR_OTHER||Treatment difference|-3.64||||0.3074|TWO_SIDED|95.0|-10.7|3.38|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||||3.38|-10.7|0.3074
71851863|NCT01375777|143218255|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.7|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-43.92|-31.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.47|-43.92|<0.001
71851864|NCT01375777|143218256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.19|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-50.45|-37.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-37.94|-50.45|<0.001
71851865|NCT01375777|143218256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.87|STANDARD_ERROR_OF_MEAN|3.13|<|0.001||95.0|-42.06|-29.69||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.69|-42.06|<0.001
71679909|NCT05127304|142877174|OTHER|||||||0.182|||||||Weighted clustered linear regression|||Ambulatory costs||||0.182
71679910|NCT05127304|142877174|OTHER|||||||0.083|||||||Weighted clustered linear regression|||Office visits costs||||0.083
71851866|NCT01375777|143218256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.33|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-38.55|-26.11||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.11|-38.55|<0.001
71851867|NCT01375777|143218256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.48|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-48.63|-36.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-36.32|-48.63|<0.001
71679911|NCT05127304|142877174|OTHER|||||||0.245|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.245
71679912|NCT05127304|142877174|OTHER|||||||0.386|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.386
71679913|NCT05127304|142877174|OTHER|||||||0.115|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.115
71679914|NCT05127304|142877174|OTHER|||||||0.237|||||||Weighted clustered linear regression|||Other medical costs||||0.237
71679915|NCT05127304|142877174|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71679916|NCT05127304|142877174|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71902342|NCT00905307|143326475|SUPERIORITY_OR_OTHER||Treatment difference|1.61||||0.1807|TWO_SIDED|95.0|-0.75|3.97|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||3.97|-0.75|0.1807
71902343|NCT00905307|143326475|SUPERIORITY_OR_OTHER||Treatment difference|-1.41||||0.1313|TWO_SIDED|95.0|-3.24|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-3.24|0.1313
71902344|NCT00905307|143326475|SUPERIORITY_OR_OTHER||Treatment difference|-0.13||||0.8879|TWO_SIDED|95.0|-1.96|1.69|||ANCOVA|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.69|-1.96|0.8879
71902345|NCT00905307|143326475|SUPERIORITY_OR_OTHER||Treatment difference|-1.24||||0.1764|TWO_SIDED|95.0|-3.05|0.56|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.56|-3.05|0.1764
71679917|NCT05127304|142877175|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Medical costs||||0.189
71679918|NCT05127304|142877175|OTHER|||||||0.314|||||||Weighted clustered linear regression|||Ambulatory costs||||0.314
71902346|NCT00905307|143326475|SUPERIORITY_OR_OTHER||Treatment difference|-1.79||||0.1111|TWO_SIDED|95.0|-4.0|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.42|-4.00|0.1111
71820262|NCT01567163|143142870|SUPERIORITY_OR_OTHER||Ratio of geometric least squares means|1.14|||||TWO_SIDED|90.0|0.84|1.55|||Mixed Models Analysis||The ratio of geometric least squares means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.|||1.55|0.84|
71902347|NCT00905307|143326476|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.2896|TWO_SIDED|95.0|-0.86|2.86|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.86|-0.86|0.2896
71820263|NCT01406717|143142905|OTHER||ANCOVA|0.0002|||||TWO_SIDED|95.0|-0.31377|0.31418||||||||0.31418|-0.31377|
71820264|NCT01406717|143142906|OTHER||ANCOVA|5.898|||||TWO_SIDED|95.0|-6.7565|18.5535||||||||18.5535|-6.7565|
71820265|NCT01406717|143142907|OTHER||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71679919|NCT05127304|142877175|OTHER|||||||0.203|||||||Weighted clustered linear regression|||Office visits costs||||0.203
71679920|NCT05127304|142877175|OTHER|||||||0.379|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.379
71679921|NCT05127304|142877175|OTHER|||||||0.815|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.815
71679922|NCT05127304|142877175|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.205
71679923|NCT05127304|142877175|OTHER|||||||0.556|||||||Weighted clustered linear regression|||Other medical costs||||0.556
71679924|NCT05127304|142877175|OTHER|||||||0.189|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||0.189
71679925|NCT05127304|142877176|OTHER|||||||0.483|||||||Weighted clustered linear regression|||Medical costs||||0.483
71679926|NCT05127304|142877176|OTHER|||||||0.002|||||||Weighted clustered linear regression|||Ambulatory costs||||0.002
71679927|NCT05127304|142877176|OTHER|||||||0.123|||||||Weighted clustered linear regression|||Office visits costs||||0.123
71679928|NCT05127304|142877176|OTHER|||||||0.003|||||||Weighted clustered linear regression|||Outpatient visits costs||||0.003
71679929|NCT05127304|142877176|OTHER|||||||0.17|||||||Weighted clustered linear regression|||Emergency room visits costs||||0.170
71820266|NCT01406717|143142909|OTHER|||||||0.6318|||||||ANCOVA|||||||0.6318
71820267|NCT01406717|143142910|OTHER|||||||0.4887|||||||ANOVA|||||||0.4887
71820268|NCT01406717|143142911|OTHER|||||||0.3813|||||||ANOVA|||||||0.3813
71820269|NCT01406717|143142912|OTHER|||||||0.99|||||||ANOVA|||||||0.9900
71820270|NCT01406717|143142913|OTHER|||||||0.0017|||||||ANOVA|||||||0.0017
71820271|NCT01406717|143142914|OTHER|||||||0.6098|||||||Mantel Haenszel|||||||0.6098
71820272|NCT01406717|143142915|OTHER|||||||0.7324|||||||ANOVA|||||||0.7324
71820273|NCT01406717|143142916|OTHER|||||||0.2984|||||||ANOVA|||||||0.2984
71820274|NCT03257995|143142917|OTHER||Mean Difference (Final Values)|0.1861|||<|0.001|TWO_SIDED|95.0|0.1293|0.2429|||ANOVA|||||0.2429|0.1293|<0.001
71820275|NCT03257995|143142917|OTHER||Mean Difference (Final Values)|0.1463|||<|0.001|TWO_SIDED|95.0|0.0898|0.2029|||ANOVA|||||0.2029|0.0898|<0.001
71820276|NCT03257995|143142917|OTHER||Mean Difference (Final Values)|-0.0398|||||TWO_SIDED|95.0|-0.0942|0.0147|||ANOVA|||||0.0147|-0.0942|
71902348|NCT00905307|143326476|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.3701|TWO_SIDED|95.0|-1.94|0.72|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.72|-1.94|0.3701
71820277|NCT03257995|143142923|OTHER||Median Difference (Final Values)|-0.02||||0.823|TWO_SIDED|95.0|-0.83|0.33|||Wilcoxon (Mann-Whitney)|||||0.33|-0.83|0.823
71902349|NCT00905307|143326476|SUPERIORITY_OR_OTHER||Treatment difference|-0.35||||0.6074|TWO_SIDED|95.0|-1.69|0.99|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.99|-1.69|0.6074
71902350|NCT00905307|143326476|SUPERIORITY_OR_OTHER||Treatment difference|-0.73||||0.2777|TWO_SIDED|95.0|-2.05|0.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.59|-2.05|0.2777
71902351|NCT00905307|143326476|SUPERIORITY_OR_OTHER||Treatment difference|-0.15||||0.8611|TWO_SIDED|95.0|-1.9|1.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.59|-1.90|0.8611
71902352|NCT00905307|143326477|SUPERIORITY_OR_OTHER||Treatment difference|-2.36||||0.3726|TWO_SIDED|95.0|-7.57|2.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||2.85|-7.57|0.3726
71679930|NCT05127304|142877176|OTHER|||||||0.582|||||||Weighted clustered linear regression|||Inpatient stay costs||||0.582
71820278|NCT03257995|143142923|OTHER||Median Difference (Final Values)|-0.02||||0.801|TWO_SIDED|95.0|-0.82|0.51|||Wilcoxon (Mann-Whitney)|||||0.51|-0.82|0.801
71902353|NCT00905307|143326477|SUPERIORITY_OR_OTHER||Treatment difference|3.8||||0.0664|TWO_SIDED|95.0|-0.26|7.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||7.85|-0.26|0.0664
71820279|NCT03257995|143142923|OTHER||Median Difference (Final Values)|0.0||||0.984|TWO_SIDED|95.0|-0.5|0.73|||Wilcoxon (Mann-Whitney)|||||0.73|-0.50|0.984
71820280|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2177|||<|0.001|TWO_SIDED|95.0|0.1482|0.2872|||ANOVA|||at 5 min||0.2872|0.1482|<0.001
71902354|NCT00905307|143326477|SUPERIORITY_OR_OTHER||Treatment difference|2.2||||0.2944|TWO_SIDED|95.0|-1.92|6.32|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||6.32|-1.92|0.2944
71902355|NCT00905307|143326477|SUPERIORITY_OR_OTHER||Treatment difference|3.86||||0.0596|TWO_SIDED|95.0|-0.16|7.89|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||7.89|-0.16|0.0596
71902356|NCT00905307|143326477|SUPERIORITY_OR_OTHER||Treatment difference|3.25||||0.1819|TWO_SIDED|95.0|-1.53|8.03|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||8.03|-1.53|0.1819
71679931|NCT05127304|142877176|OTHER|||||||0.887|||||||Weighted clustered linear regression|||Other medical costs||||0.887
71679932|NCT05127304|142877176|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Pharmacy costs||||<0.001
71679933|NCT05127304|142877176|OTHER||||||<|0.001|||||||Weighted clustered linear regression|||Total (medical + pharmacy) costs||||<0.001
71820281|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2724|||<|0.001|TWO_SIDED|95.0|0.203|0.3417|||ANOVA|||15min||0.3417|0.2030|<0.001
71820282|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.273|||<|0.001|TWO_SIDED|95.0|0.2036|0.3423|||ANOVA|||30 min||0.3423|0.2036|<0.001
71820283|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2609|||<|0.001|TWO_SIDED|95.0|0.1915|0.3302|||ANOVA|||1 hour||0.3302|0.1915|<0.001
71820284|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2494|||<|0.001|TWO_SIDED|95.0|0.18|0.3188|||ANOVA|||2 hour||0.3188|0.1800|<0.001
71820285|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2273|||<|0.001|TWO_SIDED|95.0|0.1578|0.2968|||ANOVA|||4 hour||0.2968|0.1578|<0.001
71820286|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2396|||<|0.001|TWO_SIDED|95.0|0.1697|0.3096|||ANOVA|||8 hour||0.3096|0.1697|<0.001
71820287|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2443|||<|0.001|TWO_SIDED|95.0|0.1742|0.3144|||ANOVA|||12 hour||0.3144|0.1742|<0.001
71851868|NCT01375777|143218256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.92|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-44.07|-31.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.76|-44.07|<0.001
71851869|NCT01375777|143218256|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.22|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-39.38|-27.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-27.07|-39.38|<0.001
71851870|NCT01375777|143218257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.49|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-43.43|-31.54||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-31.54|-43.43|<0.001
71851871|NCT01375777|143218257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.92|STANDARD_ERROR_OF_MEAN|2.98|<|0.001||95.0|-37.79|-26.04||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-26.04|-37.79|<0.001
71851872|NCT01375777|143218257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.86|STANDARD_ERROR_OF_MEAN|2.99|<|0.001|TWO_SIDED|95.0|-34.77|-22.95||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.95|-34.77|<0.001
71851873|NCT01375777|143218257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.58|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-42.29|-30.88||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-30.88|-42.29|<0.001
71851874|NCT01375777|143218257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.21|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-36.92|-25.51||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-25.51|-36.92|<0.001
71851875|NCT01375777|143218257|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.69|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-34.39|-22.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-22.98|-34.39|<0.001
71851876|NCT01375777|143218258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.16|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-56.75|-43.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-43.58|-56.75|<0.001
71851877|NCT01375777|143218258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|3.3|<|0.001||95.0|-46.84|-33.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.82|-46.84|<0.001
71851878|NCT01375777|143218258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.83|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-41.38|-28.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-28.28|-41.38|<0.001
71851879|NCT01375777|143218258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.47|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-52.12|-38.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-38.82|-52.12|<0.001
71851880|NCT01375777|143218258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.57|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-47.22|-33.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-33.92|-47.22|<0.001
71851881|NCT01375777|143218258|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.25|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|-42.9|-29.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|||-29.60|-42.90|<0.001
71851882|NCT02169089|143218266|SUPERIORITY||Median Difference (Final Values)|-7.78||||0.0293|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0293
71851883|NCT02169089|143218267|SUPERIORITY||Median Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -3.5 and 2.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||<0.0001
71851884|NCT02169089|143218268|SUPERIORITY||Median Difference (Final Values)|-40.7||||0.0189|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -10.3 and 17.1 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.0189
71851885|NCT02169089|143218269|SUPERIORITY||Median Difference (Final Values)|-7.5||||0.1276|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||The mean reported -5.95 and 2 represents the mean change between follow-up \& baseline visit. The statistical test (Mann-Whitney) reported Median difference of -2.6, which corresponds to the difference between the spironolactone and placebo group.|||||0.1276
71851886|NCT01838499|143218271|SUPERIORITY_OR_OTHER||Difference in proportions|0.051|||>|0.05|TWO_SIDED|80.0|-0.067|0.169|||Mixed Models Analysis||MEDI8968 - placebo|Analysis of proportion of Responders for Physician's Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.169|-0.067|>0.05
71902357|NCT00905307|143326478|SUPERIORITY_OR_OTHER||Treatment difference|0.38||||0.0685|TWO_SIDED|95.0|-0.03|0.79|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in CGI-S score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.79|-0.03|0.0685
71679934|NCT05127304|142877177|OTHER|||||||0.205|||||||Weighted clustered linear regression|||Any COPD exacerbation||||0.205
71679935|NCT05127304|142877177|OTHER|||||||0.454|||||||Weighted clustered linear regression|||Severe COPD exacerbation||||0.454
71679936|NCT05127304|142877178|OTHER|||||||0.06|||||||Rao-Scott test|||||||0.060
71820288|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.228|||<|0.001|TWO_SIDED|95.0|0.1563|0.2997|||ANOVA|||23 hour 15 min||0.2997|0.1563|<0.001
71820289|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.1954|||<|0.001|TWO_SIDED|95.0|0.1237|0.2671|||ANOVA|||23 hour 45 min||0.2671|0.1237|<0.001
71820290|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2195|||<|0.001|TWO_SIDED|95.0|0.1502|0.2889|||ANOVA|||5 min||0.2889|0.1502|<0.001
71820291|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2684|||<|0.001|TWO_SIDED|95.0|0.1988|0.338|||ANOVA|||15 min||0.3380|0.1988|<0.001
71820292|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2572|||<|0.001|TWO_SIDED|95.0|0.1879|0.3266|||ANOVA|||30 min||0.3266|0.1879|<0.001
71820293|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2348|||<|0.001|TWO_SIDED|95.0|0.1656|0.304|||ANOVA|||1 hour||0.3040|0.1656|<0.001
71820294|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2546|||<|0.001|TWO_SIDED|95.0|0.1852|0.3239|||ANOVA|||2 hour||0.3239|0.1852|<0.001
71820295|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2322|||<|0.001|TWO_SIDED|95.0|0.1627|0.3017|||ANOVA|||4 hour||0.3017|0.1627|<0.001
71820296|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2324|||<|0.001|TWO_SIDED|95.0|0.1627|0.302|||ANOVA|||8 hour||0.3020|0.1627|<0.001
71820297|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.2057|||<|0.001|TWO_SIDED|95.0|0.1359|0.2755|||ANOVA|||12 hour||0.2755|0.1359|<0.001
71851887|NCT01838499|143218272|SUPERIORITY_OR_OTHER||Difference in proportions|-0.065|||>|0.05|TWO_SIDED|80.0|-0.205|0.076|||Mixed Models Analysis|||Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.||0.076|-0.205|>0.05
71851888|NCT01838499|143218273|SUPERIORITY_OR_OTHER||Change from baseline (at week 12)|-0.03||||0.945|TWO_SIDED|80.0|-0.63|0.57|||ANCOVA||MEDI8968 - Placebo|Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate||0.57|-0.63|0.945
71679937|NCT01323010|142877302|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Chi-squared|||||||0.689
71820298|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.1625|||<|0.001|TWO_SIDED|95.0|0.0912|0.2337|||ANOVA|||23 hour 15 min||0.2337|0.0912|<0.001
71679938|NCT01323010|142877303|SUPERIORITY_OR_OTHER|||||||0.591|TWO_SIDED||||||t-test, 2 sided|||||||0.591
71679939|NCT01323010|142877304|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.||||||0.150
71679940|NCT01323010|142877305|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
71820299|NCT03257995|143142924|OTHER||Mean Difference (Final Values)|0.1793|||<|0.001|TWO_SIDED|95.0|0.108|0.2505|||ANOVA|||23 hour 45 min||0.2505|0.1080|<0.001
71820300|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<.001
71820301|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|8.5|||<|0.001|TWO_SIDED|95.0|6.4|10.6|||ANOVA|||at 15 min||10.6|6.4|<.001
71820302|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|8.6|||<|0.001|TWO_SIDED|95.0|6.5|10.7|||ANOVA|||at 30||10.7|6.5|<0.001
71820303|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|8.0|||<|0.001|TWO_SIDED|95.0|6.0|10.1|||ANOVA|||at 1 hour||10.1|6.0|<0.001
71820304|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 2 hours||9.7|5.5|<0.001
71820305|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.1|||ANOVA|||at 4 hours||9.1|5.0|<0.001
71820306|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 8 hours||9.4|5.2|<0.001
71820307|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.6|||<|0.001|TWO_SIDED|95.0|5.5|9.7|||ANOVA|||at 12 hours||9.7|5.5|<0.001
71820308|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.0|||<|0.001|TWO_SIDED|95.0|4.8|9.1|||ANOVA|||at 23 hours 15 min||9.1|4.8|<0.001
71820309|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|6.4|||<|0.001|TWO_SIDED|95.0|4.2|8.6|||ANOVA|||at 23 hours 45 min||8.6|4.2|<0.001
71820310|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.1|||<|0.001|TWO_SIDED|95.0|5.0|9.2|||ANOVA|||at 5 min||9.2|5.0|<0.001
71820311|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|8.3|||<|0.001|TWO_SIDED|95.0|6.2|10.4|||ANOVA|||at 15 min||10.4|6.2|<0.001
71820312|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|8.1|||<|0.001|TWO_SIDED|95.0|6.0|10.2|||ANOVA|||at 30 min||10.2|6.0|<0.001
71820313|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.4|||ANOVA|||at 1 hour||9.4|5.3|<0.001
71820314|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.8|||<|0.001|TWO_SIDED|95.0|5.7|9.9|||ANOVA|||at 2 hours||9.9|5.7|<0.001
71820315|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.3|||<|0.001|TWO_SIDED|95.0|5.2|9.4|||ANOVA|||at 4 hours||9.4|5.2|<0.001
71820316|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|95.0|5.3|9.5|||ANOVA|||at 8 hours||9.5|5.3|<0.001
71820317|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.2|8.4|||ANOVA|||at 12 hours||8.4|4.2|<0.001
71902358|NCT00905307|143326478|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0989|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.05|-0.60|0.0989
71902359|NCT00905307|143326478|SUPERIORITY_OR_OTHER||Treatment difference|-0.04||||0.8006|TWO_SIDED|95.0|-0.37|0.28|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||0.28|-0.37|0.8006
71679941|NCT01323010|142877306|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANOVA|||||||0.108
71679942|NCT01323010|142877308|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||ANOVA|||||||0.122
71902360|NCT00905307|143326478|SUPERIORITY_OR_OTHER||Treatment difference|-0.28||||0.0898|TWO_SIDED|95.0|-0.6|0.04|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.04|-0.60|0.0898
71902361|NCT00905307|143326478|SUPERIORITY_OR_OTHER||Treatment difference|-0.21||||0.2851|TWO_SIDED|95.0|-0.59|0.18|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||0.18|-0.59|0.2851
71679943|NCT01323010|142877310|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||ANOVA|Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.||||||0.164
71679944|NCT01323010|142877311|SUPERIORITY_OR_OTHER|||||||0.165|TWO_SIDED||||||ANOVA|||||||0.165
71820318|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|5.1|||<|0.001|TWO_SIDED|95.0|2.9|7.2|||ANOVA|||at 23 hours 15 min||7.2|2.9|<0.001
71820319|NCT03257995|143142925|OTHER||Mean Difference (Final Values)|5.9|||<|0.001|TWO_SIDED|95.0|3.7|8.0|||ANOVA|||at 23 hours 45 min||8.0|3.7|<0.001
71851889|NCT03614923|143218274|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints would be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|Least Squares (LS) Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.319||0.2364|TWO_SIDED|95.0|-1.01|0.25||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.25|-1.01|0.2364
71851890|NCT03614923|143218274|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.316||0.2024|TWO_SIDED|95.0|-1.03|0.22||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in NPS as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline NPS as covariate; and subject as random effect.||0.22|-1.03|0.2024
71851891|NCT03614923|143218275|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|4.383||0.133|TWO_SIDED|95.0|-15.34|2.06||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||2.06|-15.34|0.1330
71851892|NCT03614923|143218275|SUPERIORITY|Statistical significance for the co-primary efficacy endpoints was to be declared if both p-values for the tests of the individual hypotheses were \< 0.05.|LS Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|4.375||0.6464|TWO_SIDED|95.0|-10.7|6.67||Testing was conducted in a hierarchical manner such that the comparison of etokimab Q4W versus placebo was conducted first. If the results of this comparison were statistically significant, the etokimab Q8W treatment arm would be compared to placebo.|General linear MMRM|||A general linear mixed effects model with repeated measures (MMRM) was used including the change from Baseline in SNOT-22 as dependent variable; treatment group, stratification factor, time (Weeks 4, 8, 12, and 16), treatment by stratification factor, and treatment by time interaction as fixed effect factors; Baseline SNOT-22 as covariate; and subject as random effect.||6.67|-10.70|0.6464
71679945|NCT01323010|142877312|SUPERIORITY_OR_OTHER|||||||0.436|TWO_SIDED||||||ANOVA|||||||0.436
71679946|NCT01323010|142877313|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED||||||ANOVA|||||||0.046
71679947|NCT01323010|142877314|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED||||||ANOVA|||||||0.723
71679948|NCT01323010|142877315|SUPERIORITY_OR_OTHER|||||||0.235|TWO_SIDED||||||ANOVA|||||||0.235
71679949|NCT01323010|142877316|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||ANOVA|||||||0.284
71679950|NCT01323010|142877317|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANOVA|||||||0.905
71679951|NCT01323010|142877320|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.892
71679952|NCT01323010|142877321|SUPERIORITY_OR_OTHER|||||||0.195|TWO_SIDED||||||Chi-squared|||||||0.195
71679953|NCT01323010|142877322|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||Chi-squared, Corrected|||||||0.203
71820320|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1866|||<|0.001|TWO_SIDED|95.0|0.1121|0.2611|||ANOVA|||5 min||0.2611|0.1121|<0.001
71820321|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2249|||<|0.001|TWO_SIDED|95.0|0.1506|0.2992|||ANOVA|||15 min||0.2992|0.1506|<0.001
71820322|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2404|||<|0.001|TWO_SIDED|95.0|0.1661|0.3148|||ANOVA|||30 min||0.3148|0.1661|<0.001
71820323|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2074|||<|0.001|TWO_SIDED|95.0|0.133|0.2817|||ANOVA|||1 hour||0.2817|0.1330|<0.001
71820324|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1802|||<|0.001|TWO_SIDED|95.0|0.1059|0.2545|||ANOVA|||2 hours||0.2545|0.1059|<0.001
71820325|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1621|||<|0.001|TWO_SIDED|95.0|0.0876|0.2366|||ANOVA|||4 hours||0.2366|0.0876|<0.001
71851893|NCT01136733|143218280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||=|0.0005|TWO_SIDED|95.0|0.24|0.68|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.||0.68|0.24|=0.0005
71851894|NCT01136733|143218280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.0479|TWO_SIDED|95.0|0.38|0.98|||Log Rank|||||0.98|0.38|0.0479
71851895|NCT01136733|143218280|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.1209|TWO_SIDED|95.0|0.39|1.1|||Log Rank|||||1.10|0.39|0.1209
71851896|NCT01136733|143218281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.514|||=|0.0242|TWO_SIDED|95.0|0.299|0.884|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.||0.884|0.299|=0.0242
71851897|NCT01136733|143218281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.684|||=|0.1181|TWO_SIDED|95.0|0.411|1.138|||Log Rank|||||1.138|0.411|=0.1181
71851898|NCT01136733|143218281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751|||=|0.3157|TWO_SIDED|95.0|0.433|1.301|||Log Rank|||||1.301|0.433|=0.3157
71851899|NCT01136733|143218282|SUPERIORITY_OR_OTHER||Rate ratio|7.2|||<|0.0001|TWO_SIDED|95.0|2.3|22.5||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact||Rate ratio was based on the normal approximation.|||22.5|2.3|<0.0001
71902362|NCT00905307|143326479|SUPERIORITY_OR_OTHER|||||||0.4008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.4008
71902363|NCT00905307|143326479|SUPERIORITY_OR_OTHER|||||||0.1117|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||||0.1117
71679954|NCT01323010|142877323|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.03
71820326|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.199|||<|0.001|TWO_SIDED|95.0|0.1239|0.2742|||ANOVA|||8 hours||0.2742|0.1239|<0.001
71820327|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1747|||<|0.001|TWO_SIDED|95.0|0.0994|0.2501|||ANOVA|||12 hours||0.2501|0.0994|<0.001
71820328|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1856|||<|0.001|TWO_SIDED|95.0|0.1081|0.2631|||ANOVA|||23 hours 15 min||0.2631|0.1081|<0.001
71820329|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1484|||<|0.001|TWO_SIDED|95.0|0.0709|0.2259|||ANOVA|||23 hours 45 min||0.2259|0.0709|<0.001
71820330|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.213|||<|0.001|TWO_SIDED|95.0|0.1386|0.2873|||ANOVA|||5 min||0.2873|0.1386|<0.001
71820331|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2173|||<|0.001|TWO_SIDED|95.0|0.1426|0.292|||ANOVA|||15 min||0.2920|0.1426|<0.001
71820332|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2375|||<|0.001|TWO_SIDED|95.0|0.1632|0.3118|||ANOVA|||30 min||0.3118|0.1632|<0.001
71851900|NCT01136733|143218282|SUPERIORITY_OR_OTHER||Rate ratio|4.5||||0.0067|TWO_SIDED|95.0|1.4|14.7||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||14.7|1.4|0.0067
71851901|NCT01136733|143218282|SUPERIORITY_OR_OTHER||Rate ratio|1.6|||=|0.1007|TWO_SIDED|95.0|0.9|2.8||Analysis performed after database lock. P-value was based on the 2-sided Fisher's exact P-value.|Fisher Exact|||||2.8|0.9|=0.1007
71851902|NCT01114217|143218325|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71851903|NCT02105688|143218343|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||One-sided exact test|||A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value \<0.025 supports a conclusion that the true SVR12 is \>67%.||||<0.001
71851904|NCT02105688|143218344|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-8.3|10.0||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||10.0|-8.3|
71851905|NCT02105688|143218345|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-5.0|1.9||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.||1.9|-5.0|
71851906|NCT01075815|143218350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0235||||0.8762|TWO_SIDED|95.0|-0.1546|0.1568|||Wilcoxon two sample test|||||0.1568|-0.1546|0.8762
71851907|NCT01075815|143218351|SUPERIORITY_OR_OTHER|||||||0.3589||95.0|||||ANOVA|||||||0.3589
71851908|NCT01075815|143218352|SUPERIORITY_OR_OTHER|||||||0.0629||95.0|||||Wilcoxon two sample test|||||||0.0629
71851909|NCT01075815|143218353|SUPERIORITY_OR_OTHER|||||||0.4728||95.0|||||ANOVA|||||||0.4728
71851910|NCT01075815|143218354|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Fisher Exact|||||||0.0950
71851911|NCT01075815|143218356|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9625||||0.9179|TWO_SIDED|95.0|0.4655|1.99|||Chi-squared|||||1.9900|0.4655|0.9179
71851912|NCT01075815|143218357|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.875||||0.7271|TWO_SIDED|95.0|0.4133|1.8524|||Chi-squared|||||1.8524|0.4133|0.7271
71851913|NCT01075815|143218358|SUPERIORITY_OR_OTHER|||||||0.3267||95.0|||||Wilcoxon two sample test|||||||0.3267
71851914|NCT01075815|143218359|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||Wilcoxon two sample test|||||||0.4164
71851915|NCT01075815|143218360|SUPERIORITY_OR_OTHER|||||||0.5952||95.0|||||Wilcoxon two sample test|||||||0.5952
71851916|NCT01075815|143218362|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9444||||0.8852|TWO_SIDED|95.0|0.4347|2.0518|||Chi-squared|||||2.0518|0.4347|0.8852
71851917|NCT03005106|143218386|OTHER|Difference between treatment and control sites|Mean Difference (Final Values)|97.77|||<|0.0001|TWO_SIDED|||||Difference is (percent area of Autograft treatment site requiring autografting by Month 3) - (percent area of StrataGraft treatment site requiring autografting by Month 3).|one-sided Wilcoxin Signed RankTtest|||||||<0.0001
71851918|NCT03005106|143218387|OTHER||Percentage of participants|83.1|||||TWO_SIDED|95.0|74.4|91.8|||||95% confidence interval is derived using the normal approximation to the binomial distribution|||91.8|74.4|
71851919|NCT03005106|143218388|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|2.4|||<|0.0001|TWO_SIDED||||||1-sided, paired t-test|p-value from 1-sided, paired t-test on the mean difference(Autograft - StrataGraft)||||||<0.0001
71851920|NCT03005106|143218389|OTHER|Difference is Autograft - StrataGraft|Mean Difference (Final Values)|10.0|||<|0.0001|TWO_SIDED|||||Missing total score data were imputed using a multiple imputation analysis assuming a monotone missing data pattern. A linear regression model with ethnicity, race and age as predictive variables was used in the imputation.|1-sided, paired t-test|p-value from 1-sided, paired t-test on the difference (Autograft - StrataGraft)||||||<0.0001
71851921|NCT00321672|143218390|SUPERIORITY_OR_OTHER|||||||0.0967||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group \[1.57 (90% CI: 1.12-2.35)\] was \> than the pre-specified equivalence margin ratio of 80-125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.||||0.0967
71851922|NCT00321672|143218390|SUPERIORITY_OR_OTHER|||||||0.4884||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4884
71851923|NCT00321672|143218390|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.1031
71820333|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2013|||<|0.001|TWO_SIDED|95.0|0.1272|0.2754|||ANOVA|||1 hour||0.2754|0.1272|<0.001
71820334|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.2005|||<|0.001|TWO_SIDED|95.0|0.1262|0.2749|||ANOVA|||2 hours||0.2749|0.1262|<0.001
71820335|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1946|||<|0.001|TWO_SIDED|95.0|0.1201|0.2691|||ANOVA|||4 hours||0.2691|0.1201|<0.001
71820336|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1937|||<|0.001|TWO_SIDED|95.0|0.119|0.2684|||ANOVA|||8 hours||0.2684|0.1190|<0.001
71820337|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1619|||<|0.001|TWO_SIDED|95.0|0.087|0.2369|||ANOVA|||12 hour||0.2369|0.0870|<0.001
71820338|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1249|||<|0.001|TWO_SIDED|95.0|0.048|0.2018|||ANOVA|||23 hour 15 min||0.2018|0.0480|<0.001
71820339|NCT03257995|143142926|OTHER||Mean Difference (Final Values)|0.1546|||<|0.001|TWO_SIDED|95.0|0.0777|0.2315|||ANOVA|||23 hour 45 min||0.2315|0.0777|<0.001
71820340|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||5 min||7.0|3.1|<0.001
71820341|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|6.0|||<|0.001|TWO_SIDED|95.0|4.0|7.9|||ANOVA|||15 min||7.9|4|<0.001
71820342|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|6.6|||<|0.001|TWO_SIDED|95.0|4.6|8.5|||ANOVA|||30 min||8.5|4.6|<0.001
71820343|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||1 hour||7.4|3.5|<0.001
71820344|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.7|||<|0.001|TWO_SIDED|95.0|2.8|6.7|||ANOVA|||2 hour||6.7|2.8|<0.001
71820345|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.3|||<|0.001|TWO_SIDED|95.0|2.3|6.3|||ANOVA|||4 hour||6.3|2.3|<0.001
71820346|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7|3|<0.001
71820347|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.5|||<|0.001|TWO_SIDED|95.0|2.5|6.5|||ANOVA|||12 hour||6.5|2.5|<0.001
71820348|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.6|||<|0.001|TWO_SIDED|95.0|2.6|6.7|||ANOVA|||23 hour 15 min||6.7|2.6|<0.001
71820349|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.0|6.2|||ANOVA|||23 hour 45 min||6.2|2.0|<0.001
71820350|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||5 min||7.8|3.9|<0.001
71820351|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.8|||<|0.001|TWO_SIDED|95.0|3.9|7.8|||ANOVA|||15 min||7.8|3.9|<0.001
71820352|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|6.3|||<|0.001|TWO_SIDED|95.0|4.4|8.3|||ANOVA|||30 min||8.3|4.4|<0.001
71820353|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.5|||ANOVA|||1 hour||7.5|3.5|<0.001
71820354|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.5|||<|0.001|TWO_SIDED|95.0|3.5|7.4|||ANOVA|||2 hour||7.4|3.5|<0.001
71820355|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.1|7.0|||ANOVA|||4 hour||7.0|3.1|<0.001
71820356|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|5.0|||<|0.001|TWO_SIDED|95.0|3.0|7.0|||ANOVA|||8 hour||7.0|3.0|<0.001
71820357|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.2|||<|0.001|TWO_SIDED|95.0|2.2|6.2|||ANOVA|||12 hour||6.2|2.2|<0.001
71820358|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|3.0||||0.004|TWO_SIDED|95.0|1.0|5.0|||ANOVA|||23 hour 15 min||5.0|1.0|0.004
71820359|NCT03257995|143142927|OTHER||Mean Difference (Final Values)|4.1|||<|0.001|TWO_SIDED|95.0|2.1|6.1|||ANOVA|||23 hour 45 min||6.1|2.1|<0.001
71820360|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0249|||<|0.001|TWO_SIDED|95.0|0.0139|0.0359|||ANOVA|||5 min||0.0359|0.0139|<.001
71820361|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.033|||<|0.001|TWO_SIDED|95.0|0.022|0.044|||ANOVA|||15 min||0.0440|0.0220|<.001
71820362|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0306|||<|0.001|TWO_SIDED|95.0|0.0197|0.0416|||ANOVA|||30 min||0.0416|0.0197|<0.001
71820363|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0324|||<|0.001|TWO_SIDED|95.0|0.0214|0.0434|||ANOVA|||1 hour||0.0434|0.0214|<0.001
71820364|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
71820365|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0325|||<|0.001|TWO_SIDED|95.0|0.0215|0.0435|||ANOVA|||4 hour||0.0435|0.0215|<0.001
71820366|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0311|||<|0.001|TWO_SIDED|95.0|0.02|0.0422|||ANOVA|||8 hour||0.0422|0.0200|<0.001
71820367|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0359|||<|0.001|TWO_SIDED|95.0|0.0248|0.047|||ANOVA|||12 hour||0.0470|0.0248|<0.001
71820368|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0326|||<|0.001|TWO_SIDED|95.0|0.0211|0.044|||ANOVA|||23 hour 15 min||0.0440|0.0211|<0.001
71820369|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0301|||<|0.001|TWO_SIDED|95.0|0.0187|0.0415|||ANOVA|||23 hour 45 min||0.0415|0.0187|<0.001
71820370|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0222|||<|0.001|TWO_SIDED|95.0|0.0113|0.0332|||ANOVA|||5 min||0.0332|0.0113|<0.001
71820371|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0344|||<|0.001|TWO_SIDED|95.0|0.0234|0.0454|||ANOVA|||15 min||0.0454|0.0234|<0.001
71820372|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.029|||<|0.001|TWO_SIDED|95.0|0.018|0.0399|||ANOVA|||30 min||0.0399|0.0180|<0.001
71820373|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0169|0.0387|||ANOVA|||1 hour||0.0387|0.0169|<0.001
71820374|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0338|||<|0.001|TWO_SIDED|95.0|0.0228|0.0447|||ANOVA|||2 hour||0.0447|0.0228|<0.001
71820375|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0278|||<|0.001|TWO_SIDED|95.0|0.0168|0.0387|||ANOVA|||4 hour||0.0387|0.0168|<0.001
71820376|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0316|||<|0.001|TWO_SIDED|95.0|0.0206|0.0426|||ANOVA|||8 hour||0.0426|0.0206|<0.001
71851924|NCT00321672|143218391|SUPERIORITY_OR_OTHER|||||||0.0831||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."||||0.0831
71851925|NCT00321672|143218391|SUPERIORITY_OR_OTHER|||||||0.468||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.4680
71851926|NCT00321672|143218391|SUPERIORITY_OR_OTHER|||||||0.0896||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||||||0.0896
71851927|NCT00321672|143218392|SUPERIORITY_OR_OTHER|||||||0.0662||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours NPRS Score From Baseline During Weeks 2 to 12."||||0.0662
71851928|NCT00321672|143218392|SUPERIORITY_OR_OTHER|||||||0.5582||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.5582
71851929|NCT00321672|143218392|SUPERIORITY_OR_OTHER|||||||0.0553||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||||||0.0553
71851930|NCT01885559|143218412|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.58|TWO_SIDED|95.0|0.82|1.42|||Regression, Cox|Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site|ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)|||1.42|0.82|0.58
71851931|NCT01885559|143218413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.88|TWO_SIDED|95.0|-3.2|2.8|||shared parameter model|shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint||||2.8|-3.2|0.88
71851932|NCT01885559|143218414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.17|TWO_SIDED|95.0|-3.9|0.7||controlling for age, sex, race, and clinical site|Mixed Models Analysis||ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change|||0.7|-3.9|0.17
71851933|NCT01885559|143218415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.03||||0.85|TWO_SIDED|95.0|0.8|1.32|||Regression, Cox|adjusting for age, sex, race, and clinical site and recurrent events|Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo|||1.32|0.80|0.85
71851934|NCT01885559|143218416|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.57|TWO_SIDED|95.0|0.42|1.6|||Regression, Cox|adjusting for age, sex, race, and clinical site and accounting for recurrent events|Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo|||1.6|0.42|0.57
71851935|NCT01885559|143218417|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.032||||0.75|TWO_SIDED|95.0|-0.23|0.16|||shared parameter model|Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.||||0.16|-0.23|0.75
71820377|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0285|||<|0.001|TWO_SIDED|95.0|0.0175|0.0396|||ANOVA|||12 hour||0.0396|0.0175|<0.001
71851936|NCT01885559|143218418|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.66|TWO_SIDED|95.0|-0.26|0.16|||shared parameter model|Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.||||0.16|-0.26|0.66
71902364|NCT00905307|143326479|SUPERIORITY_OR_OTHER|||||||0.2739|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.2739
71851937|NCT01885559|143218419|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0||||0.64|TWO_SIDED|95.0|0.99|1.01|||Mixed Models Analysis|Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.|"Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.~ACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01)."|||1.01|0.99|0.64
71851938|NCT02680145|143218421|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
71851939|NCT02680145|143218422|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.001
71820378|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0281|||<|0.001|TWO_SIDED|95.0|0.0167|0.0394|||ANOVA|||23 hour 15 min||0.0394|0.0167|<0.001
71820379|NCT03257995|143142928|OTHER||Mean Difference (Final Values)|0.0266|||<|0.001|TWO_SIDED|95.0|0.0152|0.0379|||ANOVA|||23 hour 45 min||0.0379|0.0152|<0.001
71820380|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2025|||<|0.001|TWO_SIDED|95.0|0.1059|0.2952|||ANOVA|||5 min||0.2952|0.1059|<0.001
71820381|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2923|||<|0.001|TWO_SIDED|95.0|0.1979|0.3867|||ANOVA|||15 min||0.3867|0.1979|<0.001
71820382|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2657|||<|0.001|TWO_SIDED|95.0|0.1713|0.3601|||ANOVA|||30 min||0.3601|0.1713|<0.001
71820383|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2752|||<|0.001|TWO_SIDED|95.0|0.1808|0.3696|||ANOVA|||1 hour||0.3696|0.1808|<0.001
71820384|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2819|||<|0.001|TWO_SIDED|95.0|0.1875|0.3763|||ANOVA|||2 hours||0.3763|0.1875|<0.001
71820385|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.282|||<|0.001|TWO_SIDED|95.0|0.1874|0.3766|||ANOVA|||4 hours||0.3766|0.1874|<0.001
71820386|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2538|||<|0.001|TWO_SIDED|95.0|0.1585|0.3492|||ANOVA|||8 hours||0.3492|0.1585|<0.001
71820387|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2687|||<|0.001|TWO_SIDED|95.0|0.1732|0.3643|||ANOVA|||12 hours||0.3643|0.1732|<0.001
71820388|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2453|||<|0.001|TWO_SIDED|95.0|0.1473|0.3434|||ANOVA|||23 hours 15 min||0.3434|0.1473|<0.001
71820389|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.1862|||<|0.001|TWO_SIDED|95.0|0.0882|0.2842|||ANOVA|||23 hours 45 min||0.2842|0.0882|<0.001
71820390|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.1956|||<|0.001|TWO_SIDED|95.0|0.1012|0.2899|||ANOVA|||5 min||0.2899|0.1012|<0.001
71820391|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2927|||<|0.001|TWO_SIDED|95.0|0.1979|0.3875|||ANOVA|||15 min||0.3875|0.1979|<0.001
71820392|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2723|||<|0.001|TWO_SIDED|95.0|0.178|0.3667|||ANOVA|||30 min||0.3667|0.1780|<0.001
71820393|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2386|||<|0.001|TWO_SIDED|95.0|0.1445|0.3328|||ANOVA|||1 hour||0.3328|0.1445|<0.001
71820394|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2986|||<|0.001|TWO_SIDED|95.0|0.2042|0.393|||ANOVA|||2 hours||0.3930|0.2042|<0.001
71820395|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2661|||<|0.001|TWO_SIDED|95.0|0.1715|0.3607|||ANOVA|||4 hours||0.3607|0.1715|<0.001
71820396|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2558|||<|0.001|TWO_SIDED|95.0|0.1609|0.3506|||ANOVA|||8 hours||0.3506|0.1609|<0.001
71820397|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.1987|||<|0.001|TWO_SIDED|95.0|0.1036|0.2938|||ANOVA|||12 hours||0.2938|0.1036|<0.001
71820398|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.2044|||<|0.001|TWO_SIDED|95.0|0.1071|0.3017|||ANOVA|||23 hours 15 min||0.3017|0.1071|<0.001
71820399|NCT03257995|143142929|OTHER||Mean Difference (Final Values)|0.1997|||<|0.001|TWO_SIDED|95.0|0.1023|0.297|||ANOVA|||23 hours 45 min||0.2970|0.1023|<0.001
71820400|NCT03257995|143142930|OTHER||Mean Difference (Final Values)|0.2476|||<|0.001|TWO_SIDED|95.0|0.1857|0.3095|||ANOVA|||||0.3095|0.1857|<.001
71820401|NCT03257995|143142930|OTHER||Mean Difference (Final Values)|0.2448|||<|0.001|TWO_SIDED|95.0|0.183|0.3066|||ANOVA|||||0.3066|0.1830|<.001
71820402|NCT03257995|143142930|OTHER||Mean Difference (Net)|-0.0028|||||TWO_SIDED|95.0|-0.0647|0.059|||ANOVA|||||0.0590|-0.0647|
71820403|NCT03257995|143142931|OTHER||Mean Difference (Final Values)|-0.42||||0.009|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.009
71820404|NCT03257995|143142931|OTHER||Mean Difference (Final Values)|-0.42||||0.008|TWO_SIDED|95.0|-0.73|0.11|||ANOVA|||||0.11|-0.73|0.008
71820405|NCT03257995|143142932|OTHER||Mean Difference (Final Values)|33.0|||<|0.001|TWO_SIDED|95.0|25.6|40.3|||ANOVA|||||40.3|25.6|<0.001
71820406|NCT03257995|143142932|OTHER||Mean Difference (Final Values)|30.8|||<|0.001|TWO_SIDED|95.0|23.5|38.2|||ANOVA|||||38.2|23.5|<0.001
71820407|NCT01556763|143142951|SUPERIORITY_OR_OTHER||||||=|0.1||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.10
71820408|NCT01556763|143142952|SUPERIORITY_OR_OTHER||||||=|0.07||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.07
71820409|NCT01556763|143142953|SUPERIORITY_OR_OTHER||||||=|0.02||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.02
71820410|NCT01556763|143142954|SUPERIORITY_OR_OTHER||||||=|0.008||95.0|||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.||||=0.008
71820411|NCT02258464|143142955|OTHER||Hazard Ratio (Radium 223/Placebo)|0.745||||0.3339|TWO_SIDED|80.0|0.504|1.102||The SSE-FS was compared using a stratified log-rank test with a 2-sided alpha of 0.2|Log Rank|||The null hypothesis that both treatment groups have the same SSE-FS distribution will be tested against the alternative hypothesis that the distribution of SSE-FS time in radium-223 dichloride is different from the placebo group||1.102|0.504|0.3339
71820412|NCT02258464|143142956|OTHER||Hazard ratio (Radium 223/Placebo)|0.888||||0.7259|TWO_SIDED|80.0|0.576|1.37|||Log Rank|||||1.370|0.576|0.7259
71820413|NCT02258464|143142957|OTHER||Hazard ratio (Radium 223/Placebo)|0.932||||0.8785|TWO_SIDED|80.0|0.513|1.693|||Log Rank|||||1.693|0.513|0.8785
71820414|NCT02258464|143142958|OTHER||Hazard ratio (Radium 223/Placebo)|0.824||||0.524|TWO_SIDED|80.0|0.556|1.22|||Log Rank|||||1.220|0.556|0.5240
71820415|NCT02258464|143142959|OTHER||Difference (Radium 223 - Placebo) %|11.8||||0.345|TWO_SIDED|80.0|-2.7|26.3|||Cochran-Mantel-Haenszel|||||26.3|-2.7|0.345
71820416|NCT02258464|143142960|OTHER||Hazard ratio (Radium 223/Placebo)|0.968||||0.9128|TWO_SIDED|80.0|0.657|1.425|||Log Rank|||||1.425|0.657|0.9128
71820417|NCT02258464|143142961|OTHER||Hazard ratio (Radium 223/Placebo)|1.023||||0.9227|TWO_SIDED|80.0|0.753|1.391|||Log Rank|||||1.391|0.753|0.9227
71820418|NCT00932646|143142978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.139|0.205|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.205|0.139|<0.0001
71820419|NCT00932646|143142978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.14|0.208|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.208|0.140|<0.0001
71851940|NCT02680145|143218423|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Baseline score vs Follow-up score||||0.005
71851941|NCT01542502|143218429|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||ANOVA|||||||0.009
71851942|NCT01542502|143218430|SUPERIORITY_OR_OTHER|||||||0.87|||||||ANOVA|||||||0.87
71902365|NCT00905307|143326479|SUPERIORITY_OR_OTHER|||||||0.1045|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1045
71820420|NCT00932646|143142978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.124|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.124|<0.0001
71820421|NCT00932646|143142979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.114|0.176|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.176|0.114|<0.0001
71820422|NCT00932646|143142979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.116|0.179|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.179|0.116|<0.0001
71902366|NCT00905307|143326479|SUPERIORITY_OR_OTHER|||||||0.1149|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||||0.1149
71820423|NCT00932646|143142979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.016|<|0.0001||95.0|0.125|0.187|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.187|0.125|<0.0001
71820424|NCT00932646|143142980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.149|0.223|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.223|0.149|<0.0001
71820425|NCT00932646|143142980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.162|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.162|<0.0001
71820426|NCT00932646|143142980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.176|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.176|<0.0001
71820427|NCT00932646|143142981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.154|0.23|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.230|0.154|<0.0001
71820428|NCT00932646|143142981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.158|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.235|0.158|<0.0001
71820429|NCT00932646|143142981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.255|0.178|<0.0001
71820430|NCT00932646|143142982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.026||0.0003||95.0|0.045|0.148|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.148|0.045|0.0003
71902367|NCT00905307|143326480|SUPERIORITY_OR_OTHER||Relative Risk|0.89||||0.62|TWO_SIDED|95.0|0.57|1.4|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.40|0.57|0.6200
71902368|NCT00905307|143326480|SUPERIORITY_OR_OTHER||Relative Risk|1.19||||0.1501|TWO_SIDED|95.0|0.95|1.48|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.48|0.95|0.1501
71902369|NCT00905307|143326480|SUPERIORITY_OR_OTHER||Relative Risk|0.91||||0.5271|TWO_SIDED|95.0|0.66|1.25|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.25|0.66|0.5271
71902370|NCT00905307|143326480|SUPERIORITY_OR_OTHER||Relative Risk|1.02||||0.867|TWO_SIDED|95.0|0.78|1.34|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.34|0.78|0.8670
71902371|NCT00905307|143326480|SUPERIORITY_OR_OTHER||Relative Risk|1.15||||0.3892|TWO_SIDED|95.0|0.85|1.56|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.56|0.85|0.3892
71902372|NCT00905307|143326481|SUPERIORITY_OR_OTHER||Relative risk|1.06||||0.854|TWO_SIDED|95.0|0.59|1.88||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.88|0.59|0.8540
71820431|NCT00932646|143142982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.103|STANDARD_ERROR_OF_MEAN|0.026||0.0001||95.0|0.051|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.051|0.0001
71820432|NCT00932646|143142982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.026||0.0026||95.0|0.028|0.132|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.132|0.028|0.0026
71820433|NCT00932646|143142983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.195|0.306|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.306|0.195|<0.0001
71902373|NCT00905307|143326481|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.4492|TWO_SIDED|95.0|0.49|1.38||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test||1.38|0.49|0.4492
71902374|NCT00905307|143326481|SUPERIORITY_OR_OTHER||Relative Risk|0.67||||0.1854|TWO_SIDED|95.0|0.36|1.23||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.23|0.36|0.1854
71820434|NCT00932646|143142983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.19|0.302|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.302|0.190|<0.0001
71820435|NCT00932646|143142983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.179|0.291|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.291|0.179|<0.0001
71851943|NCT02168855|143218436|SUPERIORITY||Odds Ratio (OR)|1.39||||0.46|TWO_SIDED|95.0|0.58|3.29|||Regression, Logistic|This is a logistic regression model of the active versus placebo arm, while controlling for age and cigarettes smoked per day at enrollment.|The active arm is the numerator and the placebo arm is the denominator of the odds ratio|||3.29|0.58|0.46
71851944|NCT02168855|143218437|SUPERIORITY||Odds Ratio (OR)|1.9|||<|0.0001|TWO_SIDED|95.0|1.83|1.98|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in craving. Temptations are the numerator and background is the denominator.|||1.98|1.83|<0.0001
71851945|NCT02168855|143218438|SUPERIORITY||Odds Ratio (OR)|1.66|||<|0.0001|TWO_SIDED|95.0|1.51|1.83|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in negative affect T-score. Temptations are the numerator and background is the denominator.|||1.83|1.51|<0.0001
71851946|NCT02168855|143218439|SUPERIORITY||Odds Ratio (OR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.14|0.21|||Regression, Logistic|Includes random subject intercept effect|Odds ratio where temptations are the numerator and background is the denominator, that no smoking cues were seen.|||0.21|0.14|<0.0001
71851947|NCT02168855|143218440|SUPERIORITY||Odds Ratio (OR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.15|0.23|||Regression, Logistic||Odds ratio where temptations are the numerator and background is the denominator, that no other people were seen smoking nearby.|||0.23|0.15|<0.0001
71851948|NCT00635609|143218495|SUPERIORITY_OR_OTHER|||||||0.765||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.765
71851949|NCT00635609|143218496|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.290
71851950|NCT00635609|143218497|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Cochran-Mantel-Haenszel|Stratified on investigational site||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.||||0.033
71851951|NCT06091982|143218504|SUPERIORITY||Odds Ratio (OR)|10.6|||<|0.0001|TWO_SIDED|95.0|7.0|16.2|||Chi-squared|||Bivariable analysis of both groups||16.2|7.0|<0.0001
71902375|NCT00905307|143326481|SUPERIORITY_OR_OTHER||Relative Risk|0.61||||0.0946|TWO_SIDED|95.0|0.33|1.1||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.10|0.33|0.0946
71902376|NCT00905307|143326481|SUPERIORITY_OR_OTHER||Relative Risk|0.63||||0.2133||95.0|0.3|1.34||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.||1.34|0.30|0.2133
71902377|NCT03280550|143326524|SUPERIORITY||Difference in Least Squares Means|-1.14|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.59|-0.69||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.69|-1.59|<0.0001
71851952|NCT06091982|143218504|OTHER|Multiple logistic regression|Odds Ratio, log|3.4|||<|0.0001|TWO_SIDED|95.0|2.0|6.1|||Regression, Logistic|||Multivariable analysis||6.1|2.0|<0.0001
71851953|NCT06091982|143218505|SUPERIORITY||Odds Ratio (OR)|12.5|||<|0.0001|TWO_SIDED|95.0|9.1|17.1|||Chi-squared|||||17.1|9.1|<0.0001
71851954|NCT06091982|143218505|SUPERIORITY||Odds Ratio, log|4.4|||<|0.0001|TWO_SIDED|95.0|2.8|7.0|||Regression, Logistic|||||7.0|2.8|<0.0001
71851955|NCT06091982|143218506|SUPERIORITY||Odds Ratio (OR)|15.6|||<|0.0001|TWO_SIDED|95.0|11.3|21.6|||Chi-squared|||||21.6|11.3|<0.0001
71851956|NCT06091982|143218506|OTHER||Odds Ratio, log|5.2|||<|0.0001|TWO_SIDED|95.0|3.3|8.2|||Regression, Logistic|||||8.2|3.3|<0.0001
71851957|NCT03050372|143218532|EQUIVALENCE|Significance level alpha=0.05; CI=95%.||||||0.329|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ"||||0.329
71851958|NCT03050372|143218532|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.321|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.321
71851959|NCT03050372|143218532|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.687|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.687
71851960|NCT03050372|143218533|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.925|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ"||||0.925
71851961|NCT03050372|143218533|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.08|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.08
71851962|NCT03050372|143218533|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.221|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.221
71851963|NCT03050372|143218534|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.197|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ"||||0.197
71851964|NCT03050372|143218534|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.586|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.586
71851965|NCT03050372|143218534|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.298|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.298
71851966|NCT03050372|143218535|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.424|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ"||||0.424
71851967|NCT03050372|143218535|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.21|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.210
71851968|NCT03050372|143218535|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.19|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.190
71851969|NCT03050372|143218536|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.535|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ"||||0.535
71851970|NCT03050372|143218536|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.196|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.196
71851971|NCT03050372|143218536|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.092|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.092
71851972|NCT03050372|143218537|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||1|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ"||||1.00
71851973|NCT03050372|143218537|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.004|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.004
71851974|NCT03050372|143218537|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.042|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.042
71851975|NCT03050372|143218538|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.05|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ"||||0.05
71851976|NCT03050372|143218538|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.379|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.379
71851977|NCT03050372|143218538|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.284|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.284
71851978|NCT03050372|143218539|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.226|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ"||||0.226
71851979|NCT03050372|143218539|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.156|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.156
71851980|NCT03050372|143218539|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.117|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.117
71851981|NCT03050372|143218540|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.13|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ"||||0.130
71851982|NCT03050372|143218540|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.249|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero"||||0.249
71851983|NCT03050372|143218540|EQUIVALENCE|Significance level alpha=0.05; CI=95%||||||0.114|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero"||||0.114
71851984|NCT05030467|143218541|SUPERIORITY||Mean Difference (Final Values)|-0.04|||||TWO_SIDED|95.0|-0.39|0.31||||||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.31|-0.39|
71902378|NCT03280550|143326525|SUPERIORITY||Difference in Least Squares Means|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.84|-0.25||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.25|-0.84|0.0004
71851985|NCT05030467|143218542|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|1.0|1.03|||Regression, Logistic|||Outcomes were evaluated using generalized estimating equations with a log link and Poisson-distributed errors, adjusting for clinic-level clustering.||1.03|1.00|0.011
71851986|NCT05030467|143218545|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.383|TWO_SIDED|95.0|-0.38|0.15|||Regression, Linear|||We used generalized estimating equations (GEE) to adjust for the cluster design with an identify link function and normally-distributed errors||0.15|-0.38|0.383
71851987|NCT03320941|143218563|OTHER|Dose Finding|Mean Difference (Net)|-1.99|||||TWO_SIDED|95.0|-2.92|-0.21||||||||-0.21|-2.92|
71851988|NCT03320941|143218563|OTHER|Dose Finding|Mean Difference (Net)|-3.0|||||TWO_SIDED|95.0|-4.15|-1.7||||||||-1.70|-4.15|
71851989|NCT03320941|143218563|OTHER|Dose Finding|Mean Difference (Net)|-3.54|||||TWO_SIDED|95.0|-4.54|-2.26||||||||-2.26|-4.54|
71851990|NCT03320941|143218563|OTHER|Dose Finding|Mean Difference (Net)|-3.91|||||TWO_SIDED|95.0|-5.01|-2.77||||||||-2.77|-5.01|
71851991|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|2.299||||0.39|TWO_SIDED|95.0|0.344|15.35|||Regression, Logistic|||\>= 3% Percent decrease in body weight||15.350|0.344|0.390
71679955|NCT05174949|142877329|SUPERIORITY|We performed a linear regression analysis (generalized estimating equations) in which we compared both intervention groups to the sham group and added a time interaction term|Mean Difference (Final Values)|5.4|STANDARD_DEVIATION|3.58|<|0.0001|TWO_SIDED|95.0|2.4|8.4||Anode compared to sham: p = 0.0516 Cathode compared to sham: p \<.0001 . Anode change over time compared to sham p=0.0255 Cathode change over time compared to sham p\<.0001|Generalized Estimating Equations||Anode mean change = 4.13 std = 4.29 CLM = 0.5-7.7 Cathode mean change = 5.38 std = 3.58 CLM=2.4-8.4|We will report first anode compared to sham and then cathode compared to sham||8.4|2.4|<0.0001
71679956|NCT05174949|142877330|SUPERIORITY||Mean Difference (Final Values)|-24.2|STANDARD_DEVIATION|9.5||0.002|TWO_SIDED|95.0|-32.2|-16.2||anode compared to sham p= 0.0020 cathode compared to sham p = 0.0088 anode over time anode compared to sham p \<.0001 Cathode over time compared to sham p \<.0001|Regression, Cox||anode -24.2 (-32.2, -16.2) cathode -22.2 (-30.6, -13.8)|We compared anode to sham We compared cathode to sham We compared the change over time of anode to sham We compared the change over time of cathode to shal||-16.2|-32.2|0.0020
71679957|NCT05174949|142877331|SUPERIORITY||Mean Difference (Final Values)|0.077||||0.0001|TWO_SIDED|95.0|0.0|0.1||Compare anode to sham p= 0.0001 Compare cathode to sham p=0.1073 Compare anode change in time to sham p=0.0938 Compare cathode change in time to sham 0.0068|Regression, Linear|Using generalized estimating equations with group and time component|Anode = 0.077 (0.00, 0.10) Cathode = -.0.125 (-0.32 0.07 )|e compare anode to sham We compare cathode to sham||0.10|0.00|0.0001
71679958|NCT02880865|142877343|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||2.2|-2.1|
71679959|NCT02880865|142877344|NON_INFERIORITY|Non-inferiority was achieved if the lower limit of the two-sided 95% CI for the difference in percentages of participants with seropositivity between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10% for both measles and rubella results.|Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0||||||The primary hypotheses evaluated the non-inferiority of the concomitant administration of MMR and CD-JEV vaccines (Group 1) to MMR and CD-JEV vaccines given 2 months apart (Group 2) in children 9 months of age at 56 days in terms of percentage of participants achieving seropositivity to measles and rubella assuming a non-inferiority margin of 10%.||1.0|-0.3|
71679960|NCT02880865|142877345|NON_INFERIORITY|The percentage of participants with seropositivity for mumps at 56 days post-vaccination between Group 1 and Group 2 were compared using a non-inferiority test. Non-inferiority of Group 1 to Group 2 in terms of seropositivity for mumps was demonstrated if the lower limit of the two-sided 95% CI for the difference of seropositivity rates between the two groups (concurrent administration minus separate administration) at 56 days post-vaccination was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-2.0|2.1||||||||2.1|-2.0|
71820436|NCT00932646|143142984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.101|0.222|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.222|0.101|<0.0001
71679961|NCT02880865|142877346|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.2|||||Group 1/Group 2 ratio obtained using analysis of covariance (ANCOVA) with log10-transformed antibody concentration as dependent variable and treatment group as the explanatory variable adjusted for log10-transformed baseline antibody concentration.|||1.2|0.9|
71679962|NCT02880865|142877347|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Group 1/Group 2 ratio obtained using an ANCOVA method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody concentration.|||1.1|0.9|
71820437|NCT00932646|143142984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.096|0.218|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.218|0.096|<0.0001
71820438|NCT00932646|143142984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.162|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.284|0.162|<0.0001
71820439|NCT00932646|143142985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.155|0.258|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.258|0.155|<0.0001
71851992|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|15.78||||0.002|TWO_SIDED|95.0|2.844|87.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight||87.552|2.844|0.002
71851993|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|12.708||||0.002|TWO_SIDED|95.0|2.511|64.32|||Regression, Logistic|||\>= 3% Percent decrease in body weight||64.320|2.511|0.002
71851994|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|16.813|||<|0.001|TWO_SIDED|95.0|3.362|84.085|||Regression, Logistic|||\>= 3% Percent decrease in body weight||84.085|3.362|<0.001
71851995|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|1.697||||0.727|TWO_SIDED|95.0|0.087|33.006|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||33.006|0.087|0.727
71851996|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|28.26||||0.012|TWO_SIDED|95.0|2.066|386.473|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||386.473|2.066|0.012
71820440|NCT00932646|143142985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.202|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.15|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.255|0.150|<0.0001
71820441|NCT00932646|143142985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.176|0.281|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.281|0.176|<0.0001
71820442|NCT00932646|143142986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.233|0.365|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.365|0.233|<0.0001
71820443|NCT00932646|143142986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.236|0.369|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.369|0.236|<0.0001
71851997|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|10.333||||0.059|TWO_SIDED|95.0|0.914|116.82|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||116.820|0.914|0.059
71851998|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|9.456||||0.062|TWO_SIDED|95.0|0.891|100.292|||Regression, Logistic|||\>= 3% Percent decrease in body weight (Dysglycemic)||100.292|0.891|0.062
71851999|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|3.59||||0.336|TWO_SIDED|95.0|0.265|48.552|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||48.552|0.265|0.336
71820444|NCT00932646|143142986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.338|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.271|0.405|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.405|0.271|<0.0001
71820445|NCT00932646|143142987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.055||0.0163||95.0|0.024|0.239|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.239|0.024|0.0163
71820446|NCT00932646|143142987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.055||0.0118||95.0|0.031|0.247|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.247|0.031|0.0118
71820447|NCT00932646|143142987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.055||0.0076||95.0|0.04|0.256|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.256|0.040|0.0076
71820448|NCT00932646|143142988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.082|0.154|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.154|0.082|<0.0001
71679963|NCT02880865|142877348|OTHER||Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.2|||||Group 1 - Group 2|||2.2|-2.1|
71679964|NCT02880865|142877349|OTHER||Difference|1.6|||||TWO_SIDED|95.0|-1.8|4.9|||||Group 1 - Group 2|||4.9|-1.8|
71679965|NCT02880865|142877350|OTHER||Difference|0.3|||||TWO_SIDED|95.0|-0.3|1.0|||||Group 1 - Group 2|||1.0|-0.3|
71679966|NCT02880865|142877351|OTHER||Difference|4.1|||||TWO_SIDED|95.0|-3.1|11.3||||||||11.3|-3.1|
71852000|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio, log|9.112||||0.075|TWO_SIDED|95.0|0.799|103.872|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||103.872|0.799|0.075
71852001|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|29.312||||0.006|TWO_SIDED|95.0|2.665|322.412|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||322.412|2.665|0.006
71852002|NCT03320941|143218564|OTHER|Dose Finding|Odds Ratio (OR)|37.949||||0.003|TWO_SIDED|95.0|3.477|414.232|||Regression, Logistic|||\>= 3% Percent decrease in body weight (T2DM)||414.232|3.477|0.003
71852003|NCT03320941|143218565|OTHER|Dose Finding|Median Difference (Final Values)|-1.84|||||TWO_SIDED|95.0|-3.56|-0.19||||||Dysglycemic||-0.19|-3.56|
71852004|NCT03320941|143218565|OTHER|Dose Finding|Mean Difference (Final Values)|-2.98|||||TWO_SIDED|95.0|-4.56|-1.46||||||Dysglycemic||-1.46|-4.56|
71852005|NCT03320941|143218565|OTHER|Dose Finding|Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-4.71|-1.82||||||Dysglycemic||-1.82|-4.71|
71852006|NCT03320941|143218565|OTHER|Dose Finding|Mean Difference (Final Values)|-3.51|||||TWO_SIDED|95.0|-4.93|-1.74||||||Dysglycemic||-1.74|-4.93|
71852007|NCT03320941|143218565|OTHER|Dose Finding|Mean Difference (Final Values)|-1.96|||||TWO_SIDED|95.0|-3.12|-0.15||||||T2DM||-0.15|-3.12|
71852008|NCT03320941|143218565|OTHER|Dose Finding|Mean Difference (Final Values)|-2.88|||||TWO_SIDED|95.0|-4.37|-0.61||||||T2DM||-0.61|-4.37|
71852009|NCT03320941|143218565|OTHER|Dose Finding|Mean Difference (Final Values)|-3.64|||||TWO_SIDED|95.0|-5.2|-1.52||||||T2DM||-1.52|-5.20|
71679967|NCT02880865|142877352|OTHER||GMT Ratio|1.2|||||TWO_SIDED|95.0|1.0|1.4|||||Group 1 / Group 2 ratio obtained using an analysis of covariance (ANCOVA) method with log 10-transformed antibody concentration as dependent variable and treatment group as explanatory variable adjusted for log 10-transformed baseline antibody titer.|||1.4|1.0|
71679968|NCT03724877|142877359|OTHER||Adjusted hazard ratio (HR)|1.04|||||TWO_SIDED|95.0|0.79|1.38|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted forced expiratory volume1 (FEV1).|||1.38|0.79|
71679969|NCT03724877|142877360|OTHER||Adjusted HR|0.97|||||TWO_SIDED|95.0|0.87|1.09|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||1.09|0.87|
71679970|NCT03724877|142877361|OTHER||Adjusted HR|1.46|||||TWO_SIDED|95.0|1.03|2.07|||Regression, Cox||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|||2.07|1.03|
71679971|NCT03724877|142877362|OTHER||Adjusted rate ratio|0.93|||||TWO_SIDED|95.0|0.83|1.04|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Moderate/ sever exacerbation||1.04|0.83|
71820449|NCT00932646|143142988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.084|0.157|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.157|0.084|<0.0001
71820450|NCT00932646|143142988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.119|<0.0001
71820451|NCT00653263|143142990|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.||||<0.05
71679972|NCT03724877|142877362|OTHER||Adjusted rate ratio|0.94|||||TWO_SIDED|95.0|0.7|1.28|||Negative binomial regression model||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Severe exacerbation||1.28|0.70|
71679973|NCT03634033|142877368|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on adoption and sustainability using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|10.89|STANDARD_DEVIATION|18.17||0.22|TWO_SIDED|95.0|-7.27|29.05||A priori threshold for statistical significance was .05|t-test, 2 sided|16 degrees of freedom for the t-test comparing two independent groups, n=9 each.||Given 18 sites (9 in each arm) available in Michigan, in the comparison of site-level outcome of adoption and sustainability, the detectable effect size with power of 0.80 in two-sided tests at .05 level of significance was d=1.41.||29.05|-7.27|0.22
71679974|NCT03634033|142877369|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ADLs at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.23||0.73|TWO_SIDED|95.0|-0.16|0.73||A priori threshold for statistical significance was .05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering via a random effect of site.|IF minus IF+EF|Adjusted means at month 9 were calculated adjusting for baseline value of the outcome and nesting of participants within sites.||0.73|-0.16|0.73
71820452|NCT00653263|143142991|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
71820453|NCT00653263|143142992|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.||||<0.05
71852010|NCT03320941|143218565|OTHER|Dose Finding|Median Difference (Final Values)|-4.37|||||TWO_SIDED|95.0|-5.93|-2.79||||||T2DM||-2.79|-5.93|
71852011|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.011||0.278|TWO_SIDED|95.0|-3.104|0.9|||ANCOVA|||Overall Study||0.900|-3.104|0.278
71852012|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|1.013||0.216|TWO_SIDED|95.0|-3.265|0.747|||ANCOVA|||Overall Study||0.747|-3.265|0.216
71852013|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.902||0.158|TWO_SIDED|95.0|-3.069|0.504|||ANCOVA|||Overall Study||0.504|-3.069|0.158
71852014|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.89||0.053|TWO_SIDED|95.0|-3.401|0.022|||ANCOVA|||Overall Study||0.022|-3.401|0.053
71852015|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-2.36|STANDARD_ERROR_OF_MEAN|1.534||0.13|TWO_SIDED|95.0|-5.444|0.717|||ANCOVA|||Dysglycemic||0.717|-5.444|0.130
71852016|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-4.08|STANDARD_ERROR_OF_MEAN|1.534||0.011|TWO_SIDED|95.0|-7.156|-0.994|||ANCOVA|||Dysglycemic||-0.994|-7.156|0.011
71852017|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|1.325||0.215|TWO_SIDED|95.0|-4.322|0.996|||ANCOVA|||Dysglycemic||0.996|-4.322|0.215
71820454|NCT03844321|143143029|SUPERIORITY||Difference in Slopes|-0.02||||0.82|TWO_SIDED|95.0|-0.24|0.19||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|df = 1607|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.19|-0.24|.820
71679975|NCT03634033|142877370|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries IADLs using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.15|TWO_SIDED|95.0|-0.11|0.72||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|Post-intervention means were compared adjusting for baseline values and nesting of participants within sites.||0.72|-0.11|0.15
71679976|NCT03634033|142877371|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries pain at exit using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.16||0.61|TWO_SIDED|95.0|-0.23|0.39||Threshold for statistical significance was.05; no adjustments for multiple comparisons|Mixed Models Analysis|F-test was used built into mixed models that adjusted for clustering.|IF minus IF+EF|||0.39|-0.23|0.61
71820455|NCT03844321|143143029|SUPERIORITY||Difference in Slopes|-0.08||||0.11|TWO_SIDED|95.0|-0.18|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1147|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|We used a linear mixed effects model to examine the difference in effect of time on weekly WHO-5 scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks. This model accounts for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing assessment scores. The model includes a random slope and intercept, and fixed effects for intervention, time, and an intervention by time interaction.||0.02|-0.18|.110
71902379|NCT03280550|143326526|SUPERIORITY||Difference in Least Squares Means|-0.33|STANDARD_ERROR_OF_MEAN|0.14||0.0161|TWO_SIDED|95.0|-0.6|-0.06||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.06|-0.60|0.0161
71820456|NCT03844321|143143030|SUPERIORITY||Difference in Slopes|-0.03||||0.284|TWO_SIDED|95.0|-0.07|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df= 1726|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.07|.284
71820457|NCT03844321|143143030|SUPERIORITY||Difference in Slopes|0.01||||0.394|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1018|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PSS scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.394
71820458|NCT03844321|143143031|SUPERIORITY||Difference in Slopes|0.03||||0.431|TWO_SIDED|95.0|-0.04|0.09||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1591|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.09|-0.04|.431
71820459|NCT03844321|143143031|SUPERIORITY||Difference in Slopes|0.05|||<|0.001|TWO_SIDED|95.0|0.02|0.08||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1159|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Depression Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.08|0.02|<.001
71820460|NCT03844321|143143032|SUPERIORITY||Difference in Slopes|-0.01||||0.399|TWO_SIDED|95.0|-0.05|0.02||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1601|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.02|-0.05|.399
71820461|NCT03844321|143143032|SUPERIORITY||Difference in Slopes|0.02||||0.048|TWO_SIDED|95.0|0.0|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1171|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Emotional Distress-Anxiety Short Form scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|0.00|.048
71820462|NCT03844321|143143033|SUPERIORITY||Difference in Slopes|-0.02||||0.488|TWO_SIDED|95.0|-0.06|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1560|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.03|-0.06|.488
71902380|NCT03280550|143326527|SUPERIORITY||Difference in Least Squares Means|-0.56|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.84|-0.28||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.28|-0.84|0.0001
71902381|NCT03280550|143326528|SUPERIORITY||Difference in Least Squares Means|-1.01|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.43|-0.6||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.60|-1.43|<0.0001
71902382|NCT03280550|143326529|SUPERIORITY||Difference in Least Squares Means|-0.57|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.83|-0.31||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.31|-0.83|<0.0001
71902383|NCT03280550|143326530|SUPERIORITY||Difference in Least Squares Means|-16.12|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-21.86|-10.38||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-10.38|-21.86|<0.0001
71902384|NCT03280550|143326531|SUPERIORITY||Difference in Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.14||0.0023|TWO_SIDED|95.0|-0.7|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.16|-0.70|0.0023
71902385|NCT03280550|143326532|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||5.51|0.05|0.6716
71902386|NCT03280550|143326533|SUPERIORITY||Odds Ratio (OR)|0.0||||0.4815|TWO_SIDED|95.0|0.0|17.64||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||17.64|0.00|0.4815
71902387|NCT03280550|143326534|SUPERIORITY||Odds Ratio (OR)|3.71||||0.0492|TWO_SIDED|95.0|1.0|13.71|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||13.71|1.00|0.0492
71902388|NCT03280550|143326535|SUPERIORITY||Odds Ratio (OR)|0.61||||0.6716|TWO_SIDED|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||5.51|0.05|0.6716
71820463|NCT03844321|143143033|SUPERIORITY||Difference in Slopes|0.01||||0.446|TWO_SIDED|95.0|-0.01|0.03||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1179|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly PROMIS: Ability to Participate in Social Roles and Activities Short Form scores (reverse scored) in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 20 weeks.||0.03|-0.01|.446
71820464|NCT03844321|143143034|SUPERIORITY||Difference in Slopes|-0.04||||0.469|TWO_SIDED|95.0|-0.16|0.07||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1618|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used a linear mixed effects model to examine the difference in effect of time on weekly FFMQ scores in Mindfulness Light vs. Mindfulness-Based Cognitive Therapy conditions from baseline to 8 weeks.||0.07|-0.16|.469
71902389|NCT03280550|143326536|SUPERIORITY||Odds Ratio (OR)|6.25||||0.0209|TWO_SIDED|95.0|1.32|29.6||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||29.60|1.32|0.0209
71902390|NCT03280550|143326537|SUPERIORITY||Difference in Least Squares Means|-1.91|STANDARD_ERROR_OF_MEAN|0.48||0.0001|TWO_SIDED|95.0|-2.85|-0.96||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-0.96|-2.85|0.0001
71820465|NCT03844321|143143034|SUPERIORITY||Difference in Slopes|-0.06||||0.033|TWO_SIDED|95.0|-0.11|-0.01||A two-sided significance level of .05 was used.|Mixed Models Analysis|df = 1067|Slope estimate = difference in slopes between conditions (Mindfulness Light vs. Mindfulness-Based Cognitive Therapy) during time frame.|As with the primary outcome, we used linear mixed effects models to examine the effect of time on weekly FFMQ scores across both intervention conditions from baseline to 20 weeks.||-0.01|-0.11|.033
71902391|NCT03280550|143326538|SUPERIORITY||Difference in Least Squares Means|3.81|STANDARD_ERROR_OF_MEAN|1.23||0.0024|TWO_SIDED|95.0|1.38|6.24||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.24|1.38|0.0024
71902392|NCT02538666|143326588|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3693|TWO_SIDED|95.0|0.75|1.12|||Stratified Log Rank|Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS|based on stratified 3-arms Cox proportional hazard model|nivolumab + ipilimumab over placebo||1.12|0.75|0.3693
71902393|NCT02538666|143326589|SUPERIORITY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.68|0.97|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.97|0.68|
71902394|NCT02538666|143326589|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.53|1.66|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab over China Placebo||1.66|0.53|
71820466|NCT03844321|143143035|SUPERIORITY|||||||0.046||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.046
71820467|NCT03844321|143143035|SUPERIORITY|||||||0.275||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Age measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.275
71820468|NCT03844321|143143036|SUPERIORITY|||||||0.977||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.977
71820469|NCT03844321|143143036|SUPERIORITY|||||||0.341||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PSS measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.341
71820470|NCT03844321|143143037|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.885
71820471|NCT03844321|143143037|SUPERIORITY|||||||0.319||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDD measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.319
71820472|NCT03844321|143143038|SUPERIORITY|||||||0.838||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.838
71820473|NCT03844321|143143038|SUPERIORITY|||||||0.89||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: EDA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.890
71820474|NCT03844321|143143039|SUPERIORITY|||||||0.425||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.425
71852018|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|1.346||0.184|TWO_SIDED|95.0|-4.515|0.888|||ANCOVA|||Dysglycemic||0.888|-4.515|0.184
71852019|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|1.292||0.982|TWO_SIDED|95.0|-2.611|2.552|||ANCOVA|||T2DM||2.552|-2.611|0.982
71852020|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.304||0.544|TWO_SIDED|95.0|-1.809|3.401|||ANCOVA|||T2DM||3.401|-1.809|0.544
71820475|NCT03844321|143143039|SUPERIORITY|||||||0.733||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||PROMIS: APRA measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.733
71820476|NCT03844321|143143040|SUPERIORITY|||||||0.582||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.582
71820477|NCT03844321|143143040|SUPERIORITY|||||||0.666||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||FFMQ measured at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.666
71820478|NCT03844321|143143041|SUPERIORITY|||||||0.355||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.355
71820479|NCT03844321|143143041|SUPERIORITY|||||||0.361||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of psychiatric illness at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.361
71820480|NCT03844321|143143042|SUPERIORITY|||||||0.64||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.640
71820481|NCT03844321|143143042|SUPERIORITY|||||||0.396||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Presence of medical problems at the beginning of the intervention period was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.396
71820482|NCT03844321|143143043|SUPERIORITY|||||||0.004||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.004
71852021|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.188||0.552|TWO_SIDED|95.0|-3.084|1.663|||ANCOVA|||T2DM||1.663|-3.084|0.552
71852022|NCT03320941|143218566|OTHER|Dose Finding|Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|1.139||0.143|TWO_SIDED|95.0|-3.964|0.588|||ANCOVA|||T2DM||0.588|-3.964|0.143
71852023|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.206|STANDARD_ERROR_OF_MEAN|0.086||0.018|TWO_SIDED|95.0|-0.376|-0.035|||ANCOVA|||Overall Study||-0.035|-0.376|0.018
71852024|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.276|STANDARD_ERROR_OF_MEAN|0.0863||0.002|TWO_SIDED|95.0|-0.447|-0.105|||ANCOVA|||Overall Study||-0.105|-0.447|0.002
71852025|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.287|STANDARD_ERROR_OF_MEAN|0.076|<|0.001|TWO_SIDED|95.0|-0.437|-0.136|||ANCOVA|||Overall Study||-0.136|-0.437|<0.001
71852026|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.0747|<|0.001|TWO_SIDED|95.0|-0.486|-0.19|||ANCOVA|||Overall Study||-0.190|-0.486|<0.001
71852027|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.089|STANDARD_ERROR_OF_MEAN|0.0775||0.258|TWO_SIDED|95.0|-0.245|0.067|||ANCOVA|||Dysglycemic||0.067|-0.245|0.258
71852028|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.134|STANDARD_ERROR_OF_MEAN|0.0774||0.088|TWO_SIDED|95.0|-0.29|0.021|||ANCOVA|||Dysglycemic||0.021|-0.290|0.088
71852029|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.0673||0.035|TWO_SIDED|95.0|-0.282|-0.011|||ANCOVA|||Dysglycemic||-0.011|-0.282|0.035
71852030|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.0673||0.1|TWO_SIDED|95.0|-0.248|0.022|||ANCOVA|||Dysglycemic||0.022|-0.248|0.100
71852031|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.313|STANDARD_ERROR_OF_MEAN|0.1399||0.029|TWO_SIDED|95.0|-0.592|-0.033|||ANCOVA|||T2DM||-0.033|-0.592|0.029
71820483|NCT03844321|143143043|SUPERIORITY|||||||0.291||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Percentage of sessions completed was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.291
71820484|NCT03844321|143143044|SUPERIORITY|||||||0.603||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.603
71852032|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.399|STANDARD_ERROR_OF_MEAN|0.1411||0.006|TWO_SIDED|95.0|-0.681|-0.117|||ANCOVA|||T2DM||-0.117|-0.681|0.006
71852033|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.409|STANDARD_ERROR_OF_MEAN|0.1253||0.002|TWO_SIDED|95.0|-0.66|-0.159|||ANCOVA|||T2DM||-0.159|-0.660|0.002
71820485|NCT03844321|143143044|SUPERIORITY|||||||0.333||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Level of education was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.333
71820486|NCT03844321|143143045|SUPERIORITY|||||||0.224||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.224
71820487|NCT03844321|143143045|SUPERIORITY|||||||0.885||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Race was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.885
71820488|NCT03844321|143143046|SUPERIORITY|||||||0.49||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.490
71820489|NCT03844321|143143046|SUPERIORITY|||||||0.266||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Sex was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.266
71820490|NCT03844321|143143047|SUPERIORITY|||||||0.928||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 8.||||.928
71820491|NCT03844321|143143047|SUPERIORITY|||||||0.307||||||Reported p-value is for estimated weekly change in WHO-5 score by treatment by moderator interaction.|Mixed Models Analysis|||Ethnicity was analyzed as a moderator of the relationship between treatment and weekly WHO-5 scores. We added a main effect for the moderator, as well as treatment by time, moderator by time, and treatment by moderator by time interactions to the linear mixed model and used a likelihood ratio test to compare this interaction model to one without the three-way interaction. These analyses were completed over Baseline to Week 20.||||.307
71852034|NCT03320941|143218567|OTHER|Dose Finding|Mean Difference (Final Values)|-0.526|STANDARD_ERROR_OF_MEAN|0.1217|<|0.001|TWO_SIDED|95.0|-0.769|-0.282|||ANCOVA|||T2DM||-0.282|-0.769|<0.001
71852035|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.2094||0.408|TWO_SIDED|95.0|-0.589|0.241|||ANCOVA|||Overall Study||0.241|-0.589|0.408
71852036|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.505|STANDARD_ERROR_OF_MEAN|0.2115||0.018|TWO_SIDED|95.0|-0.924|-0.087|||ANCOVA|||Overall Study||-0.087|-0.924|0.018
71902395|NCT02538666|143326590|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.36|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global nivolumab||1.36|0.94|
71902396|NCT02538666|143326590|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.56|1.79|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China nivolumab||1.79|0.56|
71902397|NCT02538666|143326591|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.62|0.88|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over global placebo||0.88|0.62|
71902398|NCT02538666|143326591|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.55|0.79|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab over global placebo||0.79|0.55|
71902399|NCT02538666|143326591|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.94|1.35|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab+ ipilimumab over nivolumab||1.35|0.94|
71902400|NCT02538666|143326591|SUPERIORITY||Hazard Ratio (HR)|0.61|||||TWO_SIDED|95.0|0.33|1.12|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China placebo||1.12|0.33|
71902401|NCT02538666|143326591|SUPERIORITY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.24|0.85|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab over China placebo||0.85|0.24|
71902402|NCT02538666|143326591|SUPERIORITY||Hazard Ratio (HR)|1.34|||||TWO_SIDED|95.0|0.72|2.49|||||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China Nivolumab + Ipilimumab over China Nivolumab||2.49|0.72|
71902403|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.61|1.15|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.15|0.61|
71902404|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.55|1.04|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||1.04|0.55|
71902405|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.42|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||0.92|0.42|
71902406|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.44|0.93|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.93|0.44|
71902407|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.68|1.21|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||1.21|0.68|
71902408|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.66|1.18|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||1.18|0.66|
71902409|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.81|1.35|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.35|0.81|
71902410|NCT02538666|143326592|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.72|1.2|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||1.20|0.72|
71902411|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.58|1.09|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo||1.09|0.58|
71902412|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.5|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo||0.92|0.50|
71902413|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.73|||||TWO_SIDED|95.0|0.5|1.07|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo||1.07|0.50|
71902414|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.95|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo||0.95|0.46|
71902415|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.54|0.96|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo+Ipi over placebo||0.96|0.54|
71902416|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.49|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<10 mutations/mb: Nivo over placebo||0.89|0.49|
71902417|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.6|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo+Ipi over placebo||1.01|0.60|
71902418|NCT02538666|143326593|SUPERIORITY||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.53|0.89|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff \<13 mutations/mb: Nivo over placebo||0.89|0.53|
71902419|NCT02538666|143326594|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.76|1.09|||Stratified Log Rank||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|Global nivolumab + ipilimumab over Global placebo||1.09|0.76|
71902420|NCT02538666|143326594|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.52|1.67|||Stratified Log Rank||Hazard Ratios are based on unstratified 3-arms Cox proportional hazard model.|China nivolumab + ipilimumab over China placebo||1.67|0.52|
71902421|NCT00829166|143326596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.549|0.771|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than \[\>\] 1), and visceral/ non-visceral disease.||0.771|0.549|<0.0001
71902422|NCT00829166|143326598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.0006|TWO_SIDED|95.0|0.548|0.849|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.849|0.548|0.0006
71902423|NCT00829166|143326600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.749||||0.0003|TWO_SIDED|95.0|0.639|0.877|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.877|0.639|0.0003
71902424|NCT00829166|143326604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.658|||<|0.0001|TWO_SIDED|95.0|0.56|0.774|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.774|0.560|<0.0001
71902425|NCT00829166|143326605|SUPERIORITY_OR_OTHER||Difference in Objective Response Rates|12.7||||0.0002|TWO_SIDED|95.0|6.0|19.4|||Mantel-Haenszel chi-squared test||The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||19.4|6.0|0.0002
71902426|NCT00829166|143326607|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|14.0|||||TWO_SIDED|95.0|7.0|20.9|||||The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.|||20.9|7.0|
71902427|NCT00829166|143326609|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.703|||<|0.0001|TWO_SIDED|95.0|0.602|0.82|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.820|0.602|<0.0001
71902428|NCT00829166|143326611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0121|TWO_SIDED|95.0|0.667|0.951|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \>1), and visceral/ non-visceral disease.||0.951|0.667|0.0121
71902429|NCT03345836|143326612|SUPERIORITY||Adjusted Risk Difference|17.9|||<|0.0001|TWO_SIDED|95.0|10.0|25.8||P-value was calculated using Cochran-Mantel Haenszel (CMH) test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% confidence interval (CI) were calculated using CMH risk difference estimate.|||25.8|10.0|<0.0001
71902430|NCT03345836|143326613|SUPERIORITY||Adjusted Risk Difference|31.2|||<|0.0001|TWO_SIDED|95.0|25.5|37.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH risk difference estimate.|||37.0|25.5|<0.0001
71902431|NCT03345836|143326615|SUPERIORITY||Adjusted Treatment Difference|25.9|||<|0.0001|TWO_SIDED|95.0|18.7|33.1||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||33.1|18.7|<0.0001
71902432|NCT03345836|143326616|SUPERIORITY||Adjusted Treatment Difference|16.8|||<|0.0001|TWO_SIDED|95.0|12.0|21.6||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||21.6|12.0|<0.0001
71902433|NCT03345836|143326617|SUPERIORITY||Adjusted Treatment Difference|22.5||||0.0001|TWO_SIDED|95.0|11.1|34.0||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||34.0|11.1|0.0001
71902434|NCT03345836|143326618|SUPERIORITY||Adjusted Treatment Difference|7.5|||<|0.0001|TWO_SIDED|95.0|5.2|9.8||P-value was calculated using mixed effect model repeat measurement (MMRM) with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||9.8|5.2|< 0.0001
71902435|NCT03345836|143326619|SUPERIORITY||Adjusted Treatment Difference|24.3|||<|0.0001|TWO_SIDED|95.0|17.2|31.5||P-value was calculated using MMRM with Baseline, treatment, visit, treatment by visit interaction and stratification factors in the model.|MMRM||Point estimate and 95% CI was calculated using MMRM.|||31.5|17.2|< 0.0001
71902436|NCT03345836|143326620|SUPERIORITY||Adjusted Treatment Difference|20.7|||<|0.0001|TWO_SIDED|95.0|13.7|27.8||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||27.8|13.7|<0.0001
71902437|NCT03345836|143326621|SUPERIORITY||Adjusted Treatment Difference|22.8|||<|0.0001|TWO_SIDED|95.0|14.4|31.2||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||31.2|14.4|<0.0001
71902438|NCT03345836|143326622|SUPERIORITY||Adjusted Treatment Difference|12.1||||0.0013|TWO_SIDED|95.0|4.7|19.5||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||19.5|4.7|0.0013
71902439|NCT03345836|143326623|SUPERIORITY||Treatment Difference|-2.6||||0.2834|TWO_SIDED|95.0|-7.6|2.4||P-value was calculated using Chi-squared test.|Chi-squared||Point estimate and 95% CI was calculated using Chi-squared test.|||2.4|-7.6|0.2834
71902440|NCT03345836|143326624|SUPERIORITY||Adjusted Treatment Difference|11.5||||0.0833|TWO_SIDED|95.0|-1.5|24.4||P-value was calculated using CMH test adjusted for randomization stratification factors.|Cochran-Mantel-Haenszel||Point estimate and 95% CI was calculated using CMH.|||24.4|-1.5|0.0833
71902441|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|1.8|||||TWO_SIDED|90.0|-0.4|4.1||||||1 hour postdose||4.1|-0.4|
71902442|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|2.7|||||TWO_SIDED|90.0|0.4|4.9||||||1.5 hours postdose||4.9|0.4|
71902443|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.1|4.4||||||2 hours postdose||4.4|-0.1|
71902444|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-0.5|||||TWO_SIDED|90.0|-2.8|1.7||||||3 hours postdose||1.7|-2.8|
71852037|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.587|STANDARD_ERROR_OF_MEAN|0.1866||0.002|TWO_SIDED|95.0|-0.956|-0.217|||ANCOVA|||Overall Study||-0.217|-0.956|0.002
71852038|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|0.1831|<|0.001|TWO_SIDED|95.0|-1.188|-0.463|||ANCOVA|||Overall Study||-0.463|-1.188|<0.001
71852039|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.2054||0.293|TWO_SIDED|95.0|-0.194|0.631|||ANCOVA|||Dysglycemic||0.631|-0.194|0.293
71852040|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2068||0.665|TWO_SIDED|95.0|-0.325|0.506|||ANCOVA|||Dysglycemic||0.506|-0.325|0.665
71852041|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.1791||0.803|TWO_SIDED|95.0|-0.405|0.315|||ANCOVA|||Dysglycemic||0.315|-0.405|0.803
71852042|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.256|STANDARD_ERROR_OF_MEAN|0.1787||0.159|TWO_SIDED|95.0|-0.615|0.103|||ANCOVA|||Dysglycemic||0.103|-0.615|0.159
71852043|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-0.527|STANDARD_ERROR_OF_MEAN|0.3249||0.11|TWO_SIDED|95.0|-1.176|0.122|||ANCOVA|||T2DM||0.122|-1.176|0.110
71852044|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-1.032|STANDARD_ERROR_OF_MEAN|0.3296||0.003|TWO_SIDED|95.0|-1.691|-0.373|||ANCOVA|||T2DM||-0.373|-1.691|0.003
71852045|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-1.065|STANDARD_ERROR_OF_MEAN|0.2946|<|0.001|TWO_SIDED|95.0|-1.654|-0.476|||ANCOVA|||T2DM||-0.476|-1.654|<0.001
71852046|NCT03320941|143218568|OTHER|Dose Finding|Mean Difference (Final Values)|-1.298|STANDARD_ERROR_OF_MEAN|0.2855|<|0.001|TWO_SIDED|95.0|-1.869|-0.728|||ANCOVA|||T2DM||-0.728|-1.869|<0.001
71852047|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|2.707||0.865|TWO_SIDED|95.0|-4.898|5.822|||ANCOVA|||Overall Study||5.822|-4.898|0.865
71852048|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|2.765||0.931|TWO_SIDED|95.0|-5.235|5.716|||ANCOVA|||Overall Study||5.716|-5.235|0.931
71852049|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|2.433||0.682|TWO_SIDED|95.0|-5.817|3.82|||ANCOVA|||Overall Study||3.820|-5.817|0.682
71852050|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|2.387||0.508|TWO_SIDED|95.0|-6.312|3.142|||ANCOVA|||Overall Study||3.142|-6.312|0.508
71852051|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|4.206||0.757|TWO_SIDED|95.0|-7.138|9.749|||ANCOVA|||Dysglycemic||9.749|-7.138|0.757
71852052|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|4.267||0.999|TWO_SIDED|95.0|-8.571|8.563|||ANCOVA|||Dysglycemic||8.563|-8.571|0.999
71852053|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|3.668||0.342|TWO_SIDED|95.0|-3.848|10.88|||ANCOVA|||Dysglycemic||10.880|-3.848|0.342
71852054|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|3.673||0.43|TWO_SIDED|95.0|-4.454|10.292|||ANCOVA|||Dysglycemic||10.292|-4.454|0.430
71852055|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|3.461||0.909|TWO_SIDED|95.0|-7.312|6.52|||ANCOVA|||T2DM||6.520|-7.312|0.909
71852056|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|3.563||0.821|TWO_SIDED|95.0|-6.311|7.93|||ANCOVA|||T2DM||7.930|-6.311|0.821
71852057|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|-4.87|STANDARD_ERROR_OF_MEAN|3.19||0.132|TWO_SIDED|95.0|-11.24|1.508|||ANCOVA|||T2DM||1.508|-11.240|0.132
71852058|NCT03320941|143218569|OTHER|Dose Finding|Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|3.07||0.093|TWO_SIDED|95.0|-11.367|0.905|||ANCOVA|||T2DM||0.905|-11.367|0.093
71852059|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|2.013||0.769|TWO_SIDED|95.0|-4.579|3.393|||ANCOVA|||Overall Study||3.393|-4.579|0.769
71852060|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|2.043||0.839|TWO_SIDED|95.0|-4.462|3.63|||ANCOVA|||Overall Study||3.630|-4.462|0.839
71852061|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.807||0.496|TWO_SIDED|95.0|-4.811|2.345|||ANCOVA|||Overall Study||2.345|-4.811|0.496
71852062|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|1.774||0.237|TWO_SIDED|95.0|-5.622|1.402|||ANCOVA|||Overall Study||1.402|-5.622|0.237
71852063|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|3.2||0.758|TWO_SIDED|95.0|-5.435|7.415|||ANCOVA|||Dysglycemic||7.415|-5.435|0.758
71852064|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|3.23||0.978|TWO_SIDED|95.0|-6.574|6.397|||ANCOVA|||Dysglycemic||6.397|-6.574|0.978
71852065|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|2.79||0.512|TWO_SIDED|95.0|-3.758|7.444|||ANCOVA|||Dysglycemic||7.444|-3.758|0.512
71852066|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|2.792||0.985|TWO_SIDED|95.0|-5.552|5.657|||ANCOVA|||Dysglycemic||5.657|-5.552|0.985
71852067|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|2.599||0.428|TWO_SIDED|95.0|-7.268|3.121|||ANCOVA|||T2DM||3.121|-7.268|0.428
71852068|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|2.669||0.846|TWO_SIDED|95.0|-5.853|4.812|||ANCOVA|||T2DM||4.812|-5.853|0.846
71852069|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.388||0.095|TWO_SIDED|95.0|-8.825|0.721|||ANCOVA|||T2DM||0.721|-8.825|0.095
71820492|NCT01374802|143143066|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.29|STANDARD_DEVIATION|19.4|||TWO_SIDED|90.0|101.36|131.13|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||131.13|101.36|
71820493|NCT01374802|143143067|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|87.91|STANDARD_DEVIATION|38.3|||TWO_SIDED|90.0|68.609|112.63|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||112.630|68.609|
71820494|NCT01374802|143143068|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|128.41|STANDARD_DEVIATION|15.6|||TWO_SIDED|90.0|115.724|142.489|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir||142.489|115.724|
71820495|NCT02559609|143143079|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1||||.028
71820496|NCT02559609|143143080|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1)||||.027
71852070|NCT03320941|143218570|OTHER|Dose Finding|Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.31||0.089|TWO_SIDED|95.0|-8.61|0.623|||ANCOVA|||T2DM||0.623|-8.610|0.089
71852071|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-15.561|STANDARD_ERROR_OF_MEAN|21.4808||0.47|TWO_SIDED|95.0|-58.106|26.985|||ANCOVA|||Overall Study||26.985|-58.106|0.470
71852072|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-6.343|STANDARD_ERROR_OF_MEAN|21.6316||0.77|TWO_SIDED|95.0|-49.187|36.501|||ANCOVA|||Overall Study||36.501|-49.187|0.770
71852073|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|26.527|STANDARD_ERROR_OF_MEAN|19.1803||0.169|TWO_SIDED|95.0|-11.462|64.516|||ANCOVA|||Overall Study||64.516|-11.462|0.169
71820497|NCT02559609|143143081|SUPERIORITY|||||||0.66|||||||ANOVA|df = 1||Group A/B (contrast -1) was compared to Group C/D (contrast 1) to test Aim 2.||||.66
71820498|NCT02559609|143143082|SUPERIORITY|||||||0.89|||||||Regression, Cox|||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.89
71852074|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-12.094|STANDARD_ERROR_OF_MEAN|18.8076||0.521|TWO_SIDED|95.0|-49.345|25.157|||ANCOVA|||Overall Study||25.157|-49.345|0.521
71820499|NCT02559609|143143083|SUPERIORITY|||||||0.58|||||||ANOVA|df = 1||Group A/B (contrast -1) compared to Group C/D (contrast 1) to test Aim 2.||||.58
71820500|NCT02559609|143143084|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Group A/C (contrast -1) compared to Group B/D (contrast 1) to test Aim 1.||||.024
71820501|NCT00064025|143143085|SUPERIORITY_OR_OTHER|||||||0.701|||||||Fisher Exact|||||||0.701
71820502|NCT00064025|143143086|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
71852075|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-22.115|STANDARD_ERROR_OF_MEAN|38.7858||0.571|TWO_SIDED|95.0|-100.058|55.828|||ANCOVA|||Dysglycemic||55.828|-100.058|0.571
71820503|NCT00064025|143143087|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Paired t-test|||||||<.001
71820504|NCT03277378|143143088|NON_INFERIORITY|The hypothesis was tested at the 5% significance level.||||||0.0003|||||||Farrington- Manning non-inferioirty test|||"The hypothesis was formally addressed as:~H0: AB - TB ≤ -15% H1: AB - TB \> -15% where AB = permanent system qualification rate of Group 1 (AB) TB = permanent system qualification rate of Group 2 (TB)"||||0.0003
71820505|NCT03277378|143143089|OTHER|||||||0.25|||||||Chi-squared|||"The hypothesis was formally addressed as:~H0: P ≤ 60% H1: P \> 60% where P= percentage of physician prefer anatomic placement over targeted placement.~The analysis population included physicians who have performed both placement procedures. The hypothesis was tested at the 5% significance level."||||0.2500
71852076|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-22.948|STANDARD_ERROR_OF_MEAN|39.4994||0.564|TWO_SIDED|95.0|-102.325|56.429|||ANCOVA|||Dysglycemic||56.429|-102.325|0.564
71852077|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|31.322|STANDARD_ERROR_OF_MEAN|33.855||0.359|TWO_SIDED|95.0|-36.712|99.356|||ANCOVA|||Dysglycemic||99.356|-36.712|0.359
71852078|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-6.901|STANDARD_ERROR_OF_MEAN|34.4309||0.842|TWO_SIDED|95.0|-76.093|62.29|||ANCOVA|||Dysglycemic||62.290|-76.093|0.842
71852079|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-12.79|STANDARD_ERROR_OF_MEAN|24.3259||0.601|TWO_SIDED|95.0|-61.417|35.836|||ANCOVA|||T2DM||35.836|-61.417|0.601
71852080|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|9.302|STANDARD_ERROR_OF_MEAN|24.422||0.705|TWO_SIDED|95.0|-39.517|58.121|||ANCOVA|||T2DM||58.121|-39.517|0.705
71852081|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|20.94|STANDARD_ERROR_OF_MEAN|22.0444||0.346|TWO_SIDED|95.0|-23.126|65.007|||ANCOVA|||T2DM||65.007|-23.126|0.346
71852082|NCT03320941|143218571|OTHER|Dose Finding|Mean Difference (Final Values)|-13.863|STANDARD_ERROR_OF_MEAN|21.2205||0.516|TWO_SIDED|95.0|-56.283|28.556|||ANCOVA|||T2DM||28.556|-56.283|0.516
71852083|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|0.955|STANDARD_ERROR_OF_MEAN|3.605||0.792|TWO_SIDED|95.0|-6.185|8.095|||ANCOVA|||Overall Study||8.095|-6.185|0.792
71852084|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|-0.739|STANDARD_ERROR_OF_MEAN|3.7167||0.843|TWO_SIDED|95.0|-8.1|6.623|||ANCOVA|||Overall Study||6.623|-8.100|0.843
71852085|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|3.128|STANDARD_ERROR_OF_MEAN|3.2564||0.339|TWO_SIDED|95.0|-3.322|9.578|||ANCOVA|||Overall Study||9.578|-3.322|0.339
71852086|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|2.546|STANDARD_ERROR_OF_MEAN|3.1859||0.426|TWO_SIDED|95.0|-3.764|8.856|||ANCOVA|||Overall Study||8.856|-3.764|0.426
71820506|NCT01370603|143143126|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.|Difference in Least-squares means|-0.2|||||TWO_SIDED|97.5|-1.9|1.4|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.||1.4|-1.9|
71820507|NCT01370603|143143127|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.1|||||TWO_SIDED|97.5|-1.4|1.2|||ANCOVA|||||1.2|-1.4|
71820508|NCT01370603|143143128|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.3|||||TWO_SIDED|97.5|-1.8|1.2|||ANCOVA|||||1.2|-1.8|
71820509|NCT01370603|143143129|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-0.2|||||TWO_SIDED|97.5|-1.7|1.4|||ANCOVA|||||1.4|-1.7|
71820510|NCT01370603|143143130|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-0.5|||||TWO_SIDED|97.5|-1.9|1.0|||ANCOVA|||||1.0|-1.9|
71820511|NCT01370603|143143131|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|0.0|||||TWO_SIDED|97.5|-4.9|4.9|||constrained Longitudinal Data Analysis|||||4.9|-4.9|
71852087|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|0.504|STANDARD_ERROR_OF_MEAN|5.8734||0.932|TWO_SIDED|95.0|-11.299|12.307|||ANCOVA|||Dysglycemic||12.307|-11.299|0.932
71852088|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|-2.458|STANDARD_ERROR_OF_MEAN|6.3493||0.7|TWO_SIDED|95.0|-15.217|10.302|||ANCOVA|||Dysglycemic||10.302|-15.217|0.700
71852089|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|7.832|STANDARD_ERROR_OF_MEAN|5.0946||0.131|TWO_SIDED|95.0|-2.406|18.07|||ANCOVA|||Dysglycemic||18.070|-2.406|0.131
71852090|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|1.825|STANDARD_ERROR_OF_MEAN|5.197||0.727|TWO_SIDED|95.0|-8.619|12.269|||ANCOVA|||Dysglycemic||12.269|-8.619|0.727
71852091|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|0.828|STANDARD_ERROR_OF_MEAN|4.5876||0.857|TWO_SIDED|95.0|-8.342|9.999|||ANCOVA|||T2DM||9.999|-8.342|0.857
71852092|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|-0.696|STANDARD_ERROR_OF_MEAN|4.7173||0.883|TWO_SIDED|95.0|-10.126|8.734|||ANCOVA|||T2DM||8.734|-10.126|0.883
71852093|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|-0.975|STANDARD_ERROR_OF_MEAN|4.2883||0.821|TWO_SIDED|95.0|-9.547|7.597|||ANCOVA|||T2DM||7.597|-9.547|0.821
71852094|NCT03320941|143218572|OTHER|Dose Finding|Mean Difference (Final Values)|2.488|STANDARD_ERROR_OF_MEAN|4.1111||0.547|TWO_SIDED|95.0|-5.73|10.706|||ANCOVA|||T2DM||10.706|-5.730|0.547
71852095|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|4.954|STANDARD_ERROR_OF_MEAN|3.4006||0.148|TWO_SIDED|95.0|-1.781|11.689|||ANCOVA|||Overall Study||11.689|-1.781|0.148
71852096|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|0.993|STANDARD_ERROR_OF_MEAN|3.4645||0.775|TWO_SIDED|95.0|-5.869|7.855|||ANCOVA|||Overall Study||7.855|-5.869|0.775
71852097|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|-1.799|STANDARD_ERROR_OF_MEAN|3.0432||0.556|TWO_SIDED|95.0|-7.826|4.229|||ANCOVA|||Overall Study||4.229|-7.826|0.556
71852098|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|3.566|STANDARD_ERROR_OF_MEAN|3.0079||0.238|TWO_SIDED|95.0|-2.391|9.524|||ANCOVA|||Overall Study||9.524|-2.391|0.238
71852099|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|3.811|STANDARD_ERROR_OF_MEAN|5.4552||0.488|TWO_SIDED|95.0|-7.152|14.774|||ANCOVA|||Dysglycemic||14.774|-7.152|0.488
71852100|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|4.659|STANDARD_ERROR_OF_MEAN|5.4845||0.4|TWO_SIDED|95.0|-6.363|15.68|||ANCOVA|||Dysglycemic||15.680|-6.363|0.400
71852101|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|4.7651||0.826|TWO_SIDED|95.0|-8.525|10.626|||ANCOVA|||Dysglycemic||10.626|-8.525|0.826
71852102|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|4.182|STANDARD_ERROR_OF_MEAN|4.7627||0.384|TWO_SIDED|95.0|-5.389|13.753|||ANCOVA|||Dysglycemic||13.753|-5.389|0.384
71852103|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|5.563|STANDARD_ERROR_OF_MEAN|4.4636||0.217|TWO_SIDED|95.0|-3.36|14.486|||ANCOVA|||T2DM||14.486|-3.360|0.217
71852104|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|-2.019|STANDARD_ERROR_OF_MEAN|4.5491||0.659|TWO_SIDED|95.0|-11.112|7.074|||ANCOVA|||T2DM||7.074|-11.112|0.659
71852105|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|-4.316|STANDARD_ERROR_OF_MEAN|4.0556||0.291|TWO_SIDED|95.0|-12.423|3.791|||ANCOVA|||T2DM||3.791|-12.423|0.291
71852106|NCT03320941|143218573|OTHER|Dose Finding|Mean Difference (Final Values)|2.913|STANDARD_ERROR_OF_MEAN|4.0035||0.47|TWO_SIDED|95.0|-5.09|10.916|||ANCOVA|||T2DM||10.916|-5.090|0.470
71852107|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|1.308|STANDARD_ERROR_OF_MEAN|5.2049||0.802|TWO_SIDED|95.0|-9.001|11.617|||ANCOVA|||Overall Study||11.617|-9.001|0.802
71852108|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|-1.812|STANDARD_ERROR_OF_MEAN|5.4301||0.739|TWO_SIDED|95.0|-12.567|8.943|||ANCOVA|||Overall Study||8.943|-12.567|0.739
71852109|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|0.588|STANDARD_ERROR_OF_MEAN|4.7125||0.901|TWO_SIDED|95.0|-8.745|9.922|||ANCOVA|||Overall Study||9.922|-8.745|0.901
71852110|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|5.278|STANDARD_ERROR_OF_MEAN|4.6095||0.255|TWO_SIDED|95.0|-3.852|14.407|||ANCOVA|||Overall Study||14.407|-3.852|0.255
71852111|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|0.928|STANDARD_ERROR_OF_MEAN|8.5585||0.914|TWO_SIDED|95.0|-16.271|18.127|||ANCOVA|||Dysglycemic||18.127|-16.271|0.914
71852112|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|9.2308||0.959|TWO_SIDED|95.0|-19.03|18.07|||ANCOVA|||Dysglycemic||18.070|-19.030|0.959
71852113|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|6.572|STANDARD_ERROR_OF_MEAN|7.422||0.38|TWO_SIDED|95.0|-8.343|21.487|||ANCOVA|||Dysglycemic||21.487|-8.343|0.380
71852114|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|6.121|STANDARD_ERROR_OF_MEAN|7.5174||0.419|TWO_SIDED|95.0|-8.986|21.228|||ANCOVA|||Dysglycemic||21.228|-8.986|0.419
71679977|NCT03634033|142877372|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries depression (baseline to exit) using an evidence-based intervention (CAPABLE).|LS Means|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.04|TWO_SIDED|95.0|0.01|0.24|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||0.24|0.01|0.04
71820512|NCT00518713|143143132|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||Analysis of covariance (ANCOVA) with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0120
71902445|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-4.1|||||TWO_SIDED|90.0|-6.3|-1.8||||||4 hours postdose||-1.8|-6.3|
71902446|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-3.5|||||TWO_SIDED|90.0|-5.7|-1.2||||||6 hours postdose||-1.2|-5.7|
71902447|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-4.9|||||TWO_SIDED|90.0|-7.1|-2.6||||||12 hours postdose||-2.6|-7.1|
71902448|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-0.9|||||TWO_SIDED|90.0|-3.1|1.4||||||24 hours postdose||1.4|-3.1|
71902449|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||1 hour postdose||3.1|-1.4|
71902450|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|2.0|||||TWO_SIDED|90.0|-0.2|4.2||||||1.5 hours postdose||4.2|-0.2|
71902451|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|0.9|||||TWO_SIDED|90.0|-1.4|3.1||||||2 hours postdose||3.1|-1.4|
71902452|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-1.6|||||TWO_SIDED|90.0|-3.8|0.7||||||3 hours postdose||0.7|-3.8|
71902453|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-3.7|||||TWO_SIDED|90.0|-5.9|-1.5||||||4 hours postdose||-1.5|-5.9|
71902454|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-2.3|||||TWO_SIDED|90.0|-4.6|-0.1||||||6 hours postdose||-0.1|-4.6|
71902455|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-5.1|||||TWO_SIDED|90.0|-7.3|-2.8||||||12 hours postdose||-2.8|-7.3|
71902456|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|-0.2|||||TWO_SIDED|90.0|-2.4|2.1||||||24 hours postdose||2.1|-2.4|
71902457|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|10.8|||||TWO_SIDED|98.0|7.6|14.0||||||1 hour postdose||14.0|7.6|
71820513|NCT00518713|143143132|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0015
71820514|NCT00518713|143143132|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
71820515|NCT00518713|143143133|SUPERIORITY_OR_OTHER|||||||0.0027||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0027
71820516|NCT00518713|143143133|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
71902458|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|10.2|||||TWO_SIDED|98.0|7.0|13.4||||||1.5 hours postdose||13.4|7.0|
71902459|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|11.2|||||TWO_SIDED|98.0|8.0|14.4||||||2 hours postdose||14.4|8.0|
71902460|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|11.5|||||TWO_SIDED|98.0|8.3|14.7||||||3 hours postdose||14.7|8.3|
71902461|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|9.7|||||TWO_SIDED|98.0|6.5|12.8||||||4 hours postdose||12.8|6.5|
71902462|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|10.4|||||TWO_SIDED|98.0|7.2|13.5||||||6 hours postdose||13.5|7.2|
71902463|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|7.3|||||TWO_SIDED|98.0|4.1|10.4||||||12 hours postdose||10.4|4.1|
71902464|NCT03510663|143326635|SUPERIORITY||Least Squares Mean Difference|7.0|||||TWO_SIDED|98.0|3.8|10.2||||||24 hours postdose||10.2|3.8|
71902465|NCT01555463|143326642|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|center-adjusted||||||<.001
71902466|NCT01555463|143326643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|F-test for treatment effect of the ANCOVA model with treatment group and study center as the factors and baseline lesion count as the covariate.||||||<.001
71902467|NCT02026271|143326661|OTHER||||||||||||||||||"MTD was not determined in this study. Dose escalation decision rules were based on a standard 3+3 design modified to independently evaluate the two stratified subject groups that may exhibit different safety and tolerability profiles.~The study was planned to explore 4 veledimex (V) dose cohorts of 20, 40, 80 and 120 mg once daily, and two doses of Ad-RTS-hIL-12 (2x10\^11vp and 1x10\^12vp). Dose cohorts were treated at 10, 20, 30 and 40 mg of V. Only one dose of Ad-RTS-hIL-12 was explored (2x10\^11vp).~If ≥ 33% of subjects in the expansion cohort experience DLTs, additional subjects may be enrolled at the next lower dose, or at an intermediate dose, as recommended by the SRC.~Grp 1: After 20mg cohort, SRC approved 40mg, which was deemed the MAD due to DLTs. SRC approved 30mg cohort to determine MTD, but due to poor compliance, SRC opened a 20mg exp cohort and then an intermediate 10mg cohort. Based on V compliance and efficacy, 20mg was determined to be the optimal dose."|||
71902468|NCT01943864|143326672|SUPERIORITY_OR_OTHER||non PD rate at Week 12|10.0||||0.976|TWO_SIDED|95.0|1.2|31.7|||Exact Binomial Test|||||31.7|1.2|0.976
71902469|NCT01943864|143326673|SUPERIORITY_OR_OTHER||non PD rate at Week 12|15.0||||0.909|TWO_SIDED|95.0|3.2|37.9|||Exact Binomial Test|||||37.9|3.2|0.909
71902470|NCT01943864|143326688|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.1|||||Lower and upper limits and estimation value are in terms of weeks|||12.1|4.6|
71902471|NCT01943864|143326689|SUPERIORITY_OR_OTHER||Median PFS|10.6|||||TWO_SIDED|95.0|4.6|12.7|||||Lower and upper limits and estimation value are in terms of weeks|||12.7|4.6|
71902472|NCT01943864|143326690|SUPERIORITY_OR_OTHER||Overall Survival|20.0|||||TWO_SIDED|95.0|6.2|39.3||||||||39.3|6.2|
71902473|NCT01943864|143326691|SUPERIORITY_OR_OTHER||ORR|0.0|||||TWO_SIDED|95.0|0.0|16.8||||||||16.8|0|
71902474|NCT01943864|143326692|SUPERIORITY_OR_OTHER||ORR|5.0|||||TWO_SIDED|95.0|0.1|24.9||||||||24.9|0.1|
71820517|NCT00518713|143143133|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
71820518|NCT00518713|143143134|SUPERIORITY_OR_OTHER|||||||0.1041||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1041
71820519|NCT00518713|143143134|SUPERIORITY_OR_OTHER|||||||0.2207||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2207
71820520|NCT00518713|143143134|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0025
71820521|NCT00518713|143143135|SUPERIORITY_OR_OTHER|||||||0.1469||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1469
71820522|NCT00518713|143143135|SUPERIORITY_OR_OTHER|||||||0.0161||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0161
71820523|NCT00518713|143143135|SUPERIORITY_OR_OTHER|||||||0.0024||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0024
71820524|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.1324||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.1324
71852115|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|0.785|STANDARD_ERROR_OF_MEAN|6.6209||0.906|TWO_SIDED|95.0|-12.45|14.02|||ANCOVA|||T2DM||14.020|-12.450|0.906
71852116|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|-4.504|STANDARD_ERROR_OF_MEAN|6.8489||0.513|TWO_SIDED|95.0|-18.195|9.187|||ANCOVA|||T2DM||9.187|-18.195|0.513
71852117|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|-4.237|STANDARD_ERROR_OF_MEAN|6.23||0.499|TWO_SIDED|95.0|-16.691|8.216|||ANCOVA|||T2DM||8.216|-16.691|0.499
71852118|NCT03320941|143218574|OTHER|Dose Finding|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|5.9073||0.516|TWO_SIDED|95.0|-7.948|15.669|||ANCOVA|||T2DM||15.669|-7.948|0.516
71852119|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|44.82||||0.625|TWO_SIDED|95.0|-136.644|226.284|||ANCOVA|||Overall Study||226.284|-136.644|0.625
71852120|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|162.273||||0.079|TWO_SIDED|95.0|-19.326|343.871|||ANCOVA|||Overall Study||343.871|-19.326|0.079
71852121|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|69.062||||0.384|TWO_SIDED|95.0|-87.493|225.617|||ANCOVA|||Overall Study||225.617|-87.493|0.384
71852122|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|37.733||||0.627|TWO_SIDED|95.0|-115.58|191.045|||ANCOVA|||Overall Study||191.045|-115.580|0.627
71852123|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|22.879||||0.797|TWO_SIDED|95.0|-155.244|201.003|||ANCOVA|||Dysglycemic||201.003|-155.244|0.797
71852124|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|12.891||||0.882|TWO_SIDED|95.0|-160.215|185.996|||ANCOVA|||Dysglycemic||185.996|-160.215|0.882
71852125|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|-30.447||||0.675|TWO_SIDED|95.0|-175.796|114.902|||ANCOVA|||Dysglycemic||114.902|-175.796|0.675
71852126|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|-37.264||||0.607|TWO_SIDED|95.0|-182.099|107.571|||ANCOVA|||Dysglycemic||107.571|-182.099|0.607
71852127|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|84.822||||0.591|TWO_SIDED|95.0|-229.131|398.775|||ANCOVA|||T2DM||398.775|-229.131|0.591
71852128|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|287.328||||0.066|TWO_SIDED|95.0|-19.533|594.19|||ANCOVA|||T2DM||594.190|-19.533|0.066
71852129|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|156.017||||0.252|TWO_SIDED|95.0|-113.963|425.997|||ANCOVA|||T2DM||425.997|-113.963|0.252
71852130|NCT03320941|143218575|OTHER|Dose Finding|Mean Difference (Final Values)|103.135||||0.431|TWO_SIDED|95.0|-157.287|363.556|||ANCOVA|||T2DM||363.556|-157.287|0.431
71852131|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-65.1|STANDARD_ERROR_OF_MEAN|13.03|<|0.001|TWO_SIDED|95.0|-90.864|-39.251|||ANCOVA|||Overall Study||-39.251|-90.864|<0.001
71852132|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-67.7|STANDARD_ERROR_OF_MEAN|13.21|<|0.001|TWO_SIDED|95.0|-93.848|-41.542|||ANCOVA|||Overall Study||-41.542|-93.848|<0.001
71820525|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.0026||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0026
71820526|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0004
71820527|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.3383||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.3383
71820528|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.0159||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0159
71820529|NCT00518713|143143136|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
71820530|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0279
71820531|NCT00518713|143143136|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0010
71820532|NCT00518713|143143136|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
71820533|NCT00518713|143143143|SUPERIORITY_OR_OTHER|||||||0.721||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.7210
71820534|NCT00518713|143143143|SUPERIORITY_OR_OTHER|||||||0.2505||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.2505
71820535|NCT00518713|143143143|SUPERIORITY_OR_OTHER|||||||0.0924||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0924
71820536|NCT00518713|143143144|SUPERIORITY_OR_OTHER|||||||0.0414||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0414
71820537|NCT00518713|143143144|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||0.0044
71820538|NCT00518713|143143144|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.||||<0.0001
71820539|NCT02404493|143143161|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820540|NCT02404493|143143161|SUPERIORITY_OR_OTHER|||||||0.023||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.023
71820541|NCT02404493|143143161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|422.81|STANDARD_ERROR_OF_MEAN|122.905||0.003|TWO_SIDED|95.0|166.435|679.186||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||679.186|166.435|0.003
71820542|NCT02404493|143143162|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820543|NCT02404493|143143162|SUPERIORITY_OR_OTHER|||||||0.754||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.754
71820544|NCT02404493|143143162|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|52.3|STANDARD_ERROR_OF_MEAN|19.21||0.013|TWO_SIDED|95.0|12.23|92.373||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||92.373|12.230|0.013
71852133|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-70.8|STANDARD_ERROR_OF_MEAN|11.67|<|0.001|TWO_SIDED|95.0|-93.942|-47.735|||ANCOVA|||Overall Study||-47.735|-93.942|<0.001
71852134|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-74.4|STANDARD_ERROR_OF_MEAN|11.47|<|0.001|TWO_SIDED|95.0|-97.117|-51.704|||ANCOVA|||Overall Study||-51.704|-97.117|<0.001
71820545|NCT02404493|143143163|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820546|NCT02404493|143143163|SUPERIORITY_OR_OTHER|||||||0.271||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.271
71820547|NCT02404493|143143163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|167.95|STANDARD_ERROR_OF_MEAN|48.21||0.002|TWO_SIDED|95.0|67.046|268.854||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||268.854|67.046|0.002
71820548|NCT02404493|143143164|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
71820549|NCT02404493|143143164|SUPERIORITY_OR_OTHER|||||||0.26||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.260
71820550|NCT02404493|143143164|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|221.97|STANDARD_ERROR_OF_MEAN|100.674||0.04|TWO_SIDED|95.0|11.254|432.68||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||432.680|11.254|0.040
71820551|NCT02404493|143143165|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820552|NCT02404493|143143165|SUPERIORITY_OR_OTHER|||||||0.22||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.220
71820553|NCT02404493|143143165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|194.0|STANDARD_ERROR_OF_MEAN|68.461||0.011|TWO_SIDED|95.0|50.712|337.291||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||337.291|50.712|0.011
71820554|NCT02404493|143143166|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
71820555|NCT02404493|143143166|SUPERIORITY_OR_OTHER|||||||0.06||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.060
71820556|NCT02404493|143143166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.9|STANDARD_ERROR_OF_MEAN|79.567||0.107|TWO_SIDED|95.0|-32.266|302.063||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||302.063|-32.266|0.107
71852135|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-86.9|STANDARD_ERROR_OF_MEAN|24.35|<|0.001|TWO_SIDED|95.0|-135.78|-38.013|||ANCOVA|||Dysglycemic||-38.013|-135.780|<0.001
71852136|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-86.1|STANDARD_ERROR_OF_MEAN|24.01|<|0.001|TWO_SIDED|95.0|-134.266|-37.874|||ANCOVA|||Dysglycemic||-37.874|-134.266|<0.001
71852137|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-81.1|STANDARD_ERROR_OF_MEAN|21.04|<|0.001|TWO_SIDED|95.0|-123.369|-38.883|||ANCOVA|||Dysglycemic||-38.883|-123.369|<0.001
71852138|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-84.9|STANDARD_ERROR_OF_MEAN|21.03|<|0.001|TWO_SIDED|95.0|-127.104|-42.669|||ANCOVA|||Dysglycemic||-42.669|-127.104|<0.001
71852139|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-47.5|STANDARD_ERROR_OF_MEAN|13.52|<|0.001|TWO_SIDED|95.0|-74.493|-20.461|||ANCOVA|||T2DM||-20.461|-74.493|<0.001
71852140|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|13.93|<|0.001|TWO_SIDED|95.0|-80.914|-25.251|||ANCOVA|||T2DM||-25.251|-80.914|<0.001
71852141|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-61.8|STANDARD_ERROR_OF_MEAN|12.43|<|0.001|TWO_SIDED|95.0|-86.627|-36.937|||ANCOVA|||T2DM||-36.937|-86.627|<0.001
71852142|NCT03320941|143218576|OTHER|Dose Finding|Mean Difference (Final Values)|-65.0|STANDARD_ERROR_OF_MEAN|12.15|<|0.001|TWO_SIDED|95.0|-89.291|-40.713|||ANCOVA|||T2DM||-40.713|-89.291|<0.001
71852143|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-0.556|STANDARD_ERROR_OF_MEAN|1.845||0.764|TWO_SIDED|95.0|-4.21|3.098|||ANCOVA|||Overall Study||3.098|-4.210|0.764
71852144|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|1.289|STANDARD_ERROR_OF_MEAN|1.8741||0.493|TWO_SIDED|95.0|-2.423|5.001|||ANCOVA|||Overall Study||5.001|-2.423|0.493
71852145|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-2.621|STANDARD_ERROR_OF_MEAN|1.6596||0.117|TWO_SIDED|95.0|-5.908|0.666|||ANCOVA|||Overall Study||0.666|-5.908|0.117
71852146|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-1.818|STANDARD_ERROR_OF_MEAN|1.6349||0.269|TWO_SIDED|95.0|-5.056|1.421|||ANCOVA|||Overall Study||1.421|-5.056|0.269
71852147|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|1.671|STANDARD_ERROR_OF_MEAN|1.1677||0.159|TWO_SIDED|95.0|-0.676|4.017|||ANCOVA|||Dysglycemic||4.017|-0.676|0.159
71852148|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|5.641|STANDARD_ERROR_OF_MEAN|1.1678|<|0.001|TWO_SIDED|95.0|3.294|7.988|||ANCOVA|||Dysglycemic||7.988|3.294|<0.001
71852149|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|1.155|STANDARD_ERROR_OF_MEAN|1.0371||0.271|TWO_SIDED|95.0|-0.929|3.239|||ANCOVA|||Dysglycemic||3.239|-0.929|0.271
71852150|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|1.019||0.841|TWO_SIDED|95.0|-1.842|2.253|||ANCOVA|||Dysglycemic||2.253|-1.842|0.841
71852151|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-3.725|STANDARD_ERROR_OF_MEAN|2.518||0.144|TWO_SIDED|95.0|-8.758|1.309|||ANCOVA|||T2DM||1.309|-8.758|0.144
71679978|NCT03634033|142877373|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries fall rates at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.16|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|95.0|0.93|1.45|||Mixed Models Analysis|||||1.45|0.93|0.18
71852152|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-0.877|STANDARD_ERROR_OF_MEAN|2.5906||0.736|TWO_SIDED|95.0|-6.055|4.302|||ANCOVA|||T2DM||4.302|-6.055|0.736
71852153|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-3.431|STANDARD_ERROR_OF_MEAN|2.3113||0.143|TWO_SIDED|95.0|-8.051|1.19|||ANCOVA|||T2DM||1.190|-8.051|0.143
71852154|NCT03320941|143218577|OTHER|Dose Finding|Mean Difference (Final Values)|-1.991|STANDARD_ERROR_OF_MEAN|2.2659||0.383|TWO_SIDED|95.0|-6.521|2.538|||ANCOVA|||T2DM||2.538|-6.521|0.383
71852155|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|0.654|STANDARD_ERROR_OF_MEAN|1.1543||0.572|TWO_SIDED|95.0|-1.632|2.941|||ANCOVA|||Overall Study||2.941|-1.632|0.572
71852156|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|0.655|STANDARD_ERROR_OF_MEAN|1.1738||0.578|TWO_SIDED|95.0|-1.67|2.98|||ANCOVA|||Overall Study||2.980|-1.670|0.578
71852157|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|-1.048|STANDARD_ERROR_OF_MEAN|1.0479||0.319|TWO_SIDED|95.0|-3.124|1.028|||ANCOVA|||Overall Study||1.028|-3.124|0.319
71852158|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|-0.374|STANDARD_ERROR_OF_MEAN|1.0303||0.717|TWO_SIDED|95.0|-2.416|1.667|||ANCOVA|||Overall Study||1.667|-2.416|0.717
71902475|NCT04370028|143326697|SUPERIORITY||Mean Difference (Net)|4.57|||<|1e-05|TWO_SIDED|95.0|4.42|4.72|||t-test, 2 sided|Paired test was performed||||4.72|4.42|<0.00001
71902476|NCT04370028|143326698|SUPERIORITY||Odds Ratio (OR)|7.2|||<|1e-05|TWO_SIDED|95.0|6.01|8.67|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<26 was assessed||8.67|6.01|<0.00001
71852159|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.563||0.317|TWO_SIDED|95.0|-0.562|1.701|||ANCOVA|||Dysglycemic||1.701|-0.562|0.317
71852160|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|1.609|STANDARD_ERROR_OF_MEAN|0.5716||0.007|TWO_SIDED|95.0|0.46|2.758|||ANCOVA|||Dysglycemic||2.758|0.460|0.007
71852161|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|0.352|STANDARD_ERROR_OF_MEAN|0.5029||0.487|TWO_SIDED|95.0|-0.659|1.362|||ANCOVA|||Dysglycemic||1.362|-0.659|0.487
71852162|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.4917||0.833|TWO_SIDED|95.0|-0.884|1.092|||ANCOVA|||Dysglycemic||1.092|-0.884|0.833
71852163|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|0.605|STANDARD_ERROR_OF_MEAN|2.073||0.771|TWO_SIDED|95.0|-3.541|4.752|||ANCOVA|||T2DM||4.752|-3.541|0.771
71852164|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|2.1453||0.991|TWO_SIDED|95.0|-4.315|4.267|||ANCOVA|||T2DM||4.267|-4.315|0.991
71852165|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|-2.166|STANDARD_ERROR_OF_MEAN|1.9486||0.271|TWO_SIDED|95.0|-6.064|1.732|||ANCOVA|||T2DM||1.732|-6.064|0.271
71852166|NCT03320941|143218578|OTHER|Dose Finding|Mean Difference (Final Values)|-0.792|STANDARD_ERROR_OF_MEAN|1.8889||0.676|TWO_SIDED|95.0|-4.57|2.986|||ANCOVA|||T2DM||2.986|-4.570|0.676
71852167|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|4.7535||0.968|TWO_SIDED|95.0|-9.603|9.222|||ANCOVA|||Overall Study||9.222|-9.603|0.968
71852168|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-1.883|STANDARD_ERROR_OF_MEAN|4.7545||0.693|TWO_SIDED|95.0|-11.297|7.531|||ANCOVA|||Overall Study||7.531|-11.297|0.693
71852169|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-5.236|STANDARD_ERROR_OF_MEAN|4.2623||0.222|TWO_SIDED|95.0|-13.676|3.203|||ANCOVA|||Overall Study||3.203|-13.676|0.222
71852170|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-7.403|STANDARD_ERROR_OF_MEAN|4.1637||0.078|TWO_SIDED|95.0|-15.648|0.841|||ANCOVA|||Overall Study||0.841|-15.648|0.078
71852171|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-1.142|STANDARD_ERROR_OF_MEAN|6.0033||0.85|TWO_SIDED|95.0|-13.194|10.91|||ANCOVA|||Dysglycemic||10.910|-13.194|0.850
71852172|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-6.048|STANDARD_ERROR_OF_MEAN|5.7919||0.301|TWO_SIDED|95.0|-17.676|5.58|||ANCOVA|||Dysglycemic||5.580|-17.676|0.301
71852173|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-5.587|STANDARD_ERROR_OF_MEAN|5.2598||0.293|TWO_SIDED|95.0|-16.147|4.972|||ANCOVA|||Dysglycemic||4.972|-16.147|0.293
71852174|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-6.943|STANDARD_ERROR_OF_MEAN|5.2191||0.189|TWO_SIDED|95.0|-17.421|3.535|||ANCOVA|||Dysglycemic||3.535|-17.421|0.189
71852175|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|0.676|STANDARD_ERROR_OF_MEAN|7.2441||0.926|TWO_SIDED|95.0|-13.8|15.152|||ANCOVA|||T2DM||15.152|-13.800|0.926
71852176|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|1.202|STANDARD_ERROR_OF_MEAN|7.5086||0.873|TWO_SIDED|95.0|-13.802|16.207|||ANCOVA|||T2DM||16.207|-13.802|0.873
71902477|NCT04370028|143326699|SUPERIORITY||Odds Ratio (OR)|5.31|||<|1e-05|TWO_SIDED|95.0|4.28|6.64|||Fisher Exact||OR estimated (week 1 to week 12) the higher the better|Odds ratio of occuring MoCA score \<17 was assessed||6.64|4.28|<0.00001
71902478|NCT04370028|143326700|SUPERIORITY||Mean Difference (Net)|2.375|||<|0.07|TWO_SIDED|95.0|-0.21|4.96|||ANOVA|||Change of mean MoCA score||4.96|-0.21|<0.07
71902479|NCT04370028|143326700|SUPERIORITY||Mean Difference (Net)|4.74|||<|0.01|TWO_SIDED|95.0|4.17|5.31|||ANOVA|||Change of mean MoCA score||5.31|4.17|<0.01
71902480|NCT04370028|143326700|SUPERIORITY||Mean Difference (Net)|4.55|||<|0.01|TWO_SIDED|95.0|4.16|4.94|||ANOVA|||Change of mean MoCA score||4.94|4.16|<0.01
71902481|NCT04370028|143326700|SUPERIORITY||Mean Difference (Net)|4.49|||<|0.01|TWO_SIDED|95.0|3.7|5.27|||ANOVA|||Change of mean MoCA score||5.27|3.7|<0.01
71902482|NCT04370028|143326702|SUPERIORITY||Mean Difference (Net)|0.803|STANDARD_ERROR_OF_MEAN|0.246||0.0011|TWO_SIDED|95.0|0.321|1.28|||ANOVA|||||1.28|0.321|0.0011
71902483|NCT03302416|143326726|SUPERIORITY|Baseline scan VT vs. Post-hydrocortisone scan VT||||||0.005|||||||Linear mixed model|||||||0.005
71902484|NCT00833248|143326748|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.3||||0.8942|TWO_SIDED|95.0|-4.74|4.14|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||FAS. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.14|-4.74|0.8942
71902485|NCT00833248|143326749|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.268||||0.9123|TWO_SIDED|95.0|-5.05|4.52|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||PP analysis set. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||4.52|-5.05|0.9123
71902486|NCT01718509|143326757|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-2.04|-1.28|||Mixed Models Repeated Measures Analysis|||||-1.28|-2.04|<0.001
71902487|NCT01718509|143326758|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
71902488|NCT01718509|143326759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||||||<0.001
71902489|NCT01718509|143326760|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-5.41|||<|0.001|TWO_SIDED|95.0|-6.39|-4.44|||Mixed Models Repeated Measures Analysis|||||-4.44|-6.39|<0.001
71902490|NCT01718509|143326761|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-7.94|||<|0.001|TWO_SIDED|95.0|-9.51|-6.36|||Mixed Models Repeated Measures Analysis|||||-6.36|-9.51|<0.001
71902491|NCT01718509|143326762|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.196||||0.002|TWO_SIDED|95.0|-0.321|-0.07|||ANCOVA|||||-0.070|-0.321|0.002
71902492|NCT01718509|143326763|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.077||||0.234|TWO_SIDED|95.0|-0.205|0.05|||ANCOVA|||||0.050|-0.205|0.234
71902493|NCT01718509|143326764|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.03||||0.185|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA|||||0.08|-0.02|0.185
71902494|NCT01718509|143326765|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
71902495|NCT01718509|143326766|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.77|-1.69||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.69|-2.77|<0.001
71902496|NCT01718509|143326767|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.27||||0.011|TWO_SIDED|95.0|0.29|2.24||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.24|0.29|0.011
71820557|NCT02404493|143143167|SUPERIORITY_OR_OTHER|||||||0.692||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.692
71820558|NCT02404493|143143167|SUPERIORITY_OR_OTHER|||||||0.541||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.541
71820559|NCT02404493|143143167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.492|TWO_SIDED|95.0|-0.25|0.502||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.502|-0.250|0.492
71820560|NCT02404493|143143168|SUPERIORITY_OR_OTHER|||||||0.017||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.017
71820561|NCT02404493|143143168|SUPERIORITY_OR_OTHER|||||||0.223||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.223
71852177|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-5.779|STANDARD_ERROR_OF_MEAN|6.6977||0.391|TWO_SIDED|95.0|-19.164|7.605|||ANCOVA|||T2DM||7.605|-19.164|0.391
71852178|NCT03320941|143218579|OTHER|Dose Finding|Mean Difference (Final Values)|-7.591|STANDARD_ERROR_OF_MEAN|6.3822||0.239|TWO_SIDED|95.0|-20.345|5.163|||ANCOVA|||T2DM||5.163|-20.345|0.239
71852179|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-3.086|STANDARD_ERROR_OF_MEAN|2.8326||0.278|TWO_SIDED|95.0|-8.696|2.525|||ANCOVA|||Overall Study||2.525|-8.696|0.278
71902497|NCT01718509|143326767|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-4.44|-2.76||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-2.76|-4.44|<0.001
71902498|NCT01718509|143326767|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.21|||<|0.001|TWO_SIDED|95.0|-5.09|-3.33||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.33|-5.09|<0.001
71820562|NCT02404493|143143168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.231||0.518|TWO_SIDED|95.0|-0.635|0.331||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.331|-0.635|0.518
71820563|NCT02404493|143143169|SUPERIORITY_OR_OTHER|||||||0.005||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.005
71820564|NCT02404493|143143169|SUPERIORITY_OR_OTHER|||||||0.821||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.821
71820565|NCT02404493|143143169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.351||0.06|TWO_SIDED|95.0|-1.435|0.032||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.032|-1.435|0.060
71852180|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-0.977|STANDARD_ERROR_OF_MEAN|2.859||0.733|TWO_SIDED|95.0|-6.639|4.686|||ANCOVA|||Overall Study||4.686|-6.639|0.733
71852181|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-4.507|STANDARD_ERROR_OF_MEAN|2.5118||0.075|TWO_SIDED|95.0|-9.482|0.468|||ANCOVA|||Overall Study||0.468|-9.482|0.075
71852182|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-2.268|STANDARD_ERROR_OF_MEAN|2.4659||0.36|TWO_SIDED|95.0|-7.152|2.616|||ANCOVA|||Overall Study||2.616|-7.152|0.360
71852183|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-3.147|STANDARD_ERROR_OF_MEAN|4.1699||0.416|TWO_SIDED|95.0|-11.792|4.959|||ANCOVA|||Dysglycemic||4.959|-11.792|0.416
71852184|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-1.634|STANDARD_ERROR_OF_MEAN|4.1121||0.693|TWO_SIDED|95.0|-9.893|6.625|||ANCOVA|||Dysglycemic||6.625|-9.893|0.693
71852185|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-2.906|STANDARD_ERROR_OF_MEAN|3.6351||0.428|TWO_SIDED|95.0|-10.207|4.396|||ANCOVA|||Dysglycemic||4.396|-10.207|0.428
71852186|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|2.201|STANDARD_ERROR_OF_MEAN|3.6414||0.548|TWO_SIDED|95.0|-5.113|9.515|||ANCOVA|||Dysglycemic||9.515|-5.113|0.548
71852187|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-2.636|STANDARD_ERROR_OF_MEAN|3.8828||0.5|TWO_SIDED|95.0|-10.4|5.128|||ANCOVA|||T2DM||5.128|-10.400|0.500
71852188|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-0.826|STANDARD_ERROR_OF_MEAN|3.9906||0.837|TWO_SIDED|95.0|-8.805|7.154|||ANCOVA|||T2DM||7.154|-8.805|0.837
71902499|NCT01718509|143326768|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-9.28|||<|0.001|TWO_SIDED|95.0|-11.44|-7.12||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-7.12|-11.44|<0.001
71852189|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-5.594|STANDARD_ERROR_OF_MEAN|3.4818||0.113|TWO_SIDED|95.0|-12.556|1.368|||ANCOVA|||T2DM||1.368|-12.556|0.113
71852190|NCT03320941|143218580|OTHER|Dose Finding|Mean Difference (Final Values)|-5.66|STANDARD_ERROR_OF_MEAN|3.3512||0.096|TWO_SIDED|95.0|-12.361|1.041|||ANCOVA|||T2DM||1.041|-12.361|0.096
71852191|NCT01183013|143218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1571||95.0|-0.41|0.07||The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.|ANCOVA|||Treatment comparisons are for fixed dose combination versus monotherapy.||0.07|-0.41|0.1571
71679979|NCT03634033|142877373|SUPERIORITY||Odds Ratio (OR)|1.16||||0.18|TWO_SIDED|95.0|0.93|1.45||Threshold for statistical significance was .05; no adjustment for multiple comparisons.|Mixed Models Analysis||Odds ratio for IF versus IF+EF|Occurrence of falls was analyzed with adjustment for baseline and nesting of participants within sites.||1.45|0.93|.18
71852192|NCT01183013|143218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0016|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.14|-0.60|0.0016
71852193|NCT01183013|143218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0006|TWO_SIDED|95.0|-0.64|-0.18|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.18|-0.64|0.0006
71852194|NCT01183013|143218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.0003|TWO_SIDED|95.0|-0.67|-0.2|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.20|-0.67|0.0003
71852195|NCT01183013|143218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.91|-0.44|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.44|-0.91|<0.0001
71852196|NCT01183013|143218582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.66|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-0.66|-1.12|<0.0001
71852197|NCT01183013|143218583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.246||||0.4639||95.0|0.692|2.242|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.242|0.692|0.4639
71852198|NCT01183013|143218583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.746||||0.0546||95.0|0.989|3.083|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.083|0.989|0.0546
71852199|NCT01183013|143218583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.903||||0.0254||95.0|1.083|3.345|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.345|1.083|0.0254
71852200|NCT01183013|143218583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.804||||0.0009||95.0|1.524|5.159|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.159|1.524|0.0009
71852201|NCT01183013|143218583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.429|||<|0.0001||95.0|2.947|10.001|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.001|2.947|<0.0001
71852202|NCT01183013|143218583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.614|||<|0.0001||95.0|5.187|17.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||17.821|5.187|<0.0001
71852203|NCT01183013|143218584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.126||||0.7359||95.0|0.565|2.243|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.243|0.565|0.7359
71852204|NCT01183013|143218584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.905||||0.0363||95.0|1.042|3.484|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||3.484|1.042|0.0363
71679980|NCT03634033|142877374|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) on beneficiaries ED Visits at exit after an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.01||0.86|TWO_SIDED|95.0|0.79|1.22||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|Mixed Models Analysis|Adjustment for baseline and nesting of participants within sites.||||1.22|0.79|0.86
71852205|NCT01183013|143218584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.269||||0.4039||95.0|0.726|2.217|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.217|0.726|0.4039
71852206|NCT01183013|143218584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.22||||0.0345||95.0|1.06|4.649|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.649|1.060|0.0345
71852207|NCT01183013|143218584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.58|||<|0.0001||95.0|2.263|9.266|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||9.266|2.263|<0.0001
71852208|NCT01183013|143218584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.066|||<|0.0001||95.0|2.53|10.145|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||10.145|2.530|<0.0001
71852209|NCT01183013|143218585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.754||95.0|0.637|1.863|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.863|0.637|0.7540
71852210|NCT01183013|143218585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.707||||0.0506||95.0|0.999|2.918|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.918|0.999|0.0506
71820566|NCT02404493|143143170|SUPERIORITY_OR_OTHER|||||||0.007||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.007
71820567|NCT02404493|143143170|SUPERIORITY_OR_OTHER|||||||0.051||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.051
71820568|NCT02404493|143143170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.188||0.926|TWO_SIDED|95.0|-0.41|0.375||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.375|-0.410|0.926
71820569|NCT02404493|143143171|SUPERIORITY_OR_OTHER|||||||0.58||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.580
71820570|NCT02404493|143143171|SUPERIORITY_OR_OTHER|||||||0.363||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.363
71820571|NCT02404493|143143171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.539|TWO_SIDED|95.0|-0.531|0.286||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.286|-0.531|0.539
71820572|NCT02404493|143143172|SUPERIORITY_OR_OTHER|||||||0.055||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.055
71820573|NCT02404493|143143172|SUPERIORITY_OR_OTHER|||||||0.076||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.076
71820574|NCT02404493|143143172|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.682|TWO_SIDED|95.0|-0.672|0.449||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.449|-0.672|0.682
71820575|NCT02404493|143143173|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
71820576|NCT02404493|143143173|SUPERIORITY_OR_OTHER|||||||0.025||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.025
71820577|NCT02404493|143143173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.991|TWO_SIDED|95.0|-0.509|0.514||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.514|-0.509|0.991
71820578|NCT02404493|143143174|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820579|NCT02404493|143143174|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820580|NCT02404493|143143174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.334|TWO_SIDED|95.0|-0.214|0.6||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.600|-0.214|0.334
71820581|NCT02404493|143143175|SUPERIORITY_OR_OTHER|||||||0.169||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.169
71820582|NCT02404493|143143175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.317|TWO_SIDED|95.0|-0.778|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-0.778|0.317
71820583|NCT02404493|143143176|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820584|NCT02404493|143143176|SUPERIORITY_OR_OTHER|||||||0.182||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.182
71902500|NCT01718509|143326769|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.96||||0.298|TWO_SIDED|95.0|-2.77|0.85||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||0.85|-2.77|0.298
71679981|NCT03634033|142877375|SUPERIORITY|Examination of intensity of facilitation (IF vs IF+EF) needed on beneficiaries hospitalizations (baseline to exit) using an evidence-based intervention (CAPABLE).|Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.01||0.95|TWO_SIDED|95.0|0.72|1.42|||F-test|F-test was used (related to the t-test arithmetically), built into mixed models that adjusted for clustering.||||1.42|0.72|0.95
71679982|NCT03634033|142877376|SUPERIORITY|Examination of clinician attitude on facilitation (IF vs IF+EF) at exit when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|5.11|STANDARD_ERROR_OF_MEAN|2.55||0.05|TWO_SIDED|95.0|0.09|10.14|||Mixed Models Analysis|||Mixed modeling was used to account for nesting of clinicians within sites.||10.14|0.09|0.05
71679983|NCT03634033|142877377|OTHER|Examination of clinician self-efficacy on facilitation (IF vs IF+EF) (baseline to exit) when using an evidence-based intervention (CAPABLE).|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.36||0.54|TWO_SIDED|95.0|-0.51|0.97||Threshold for statistical significance was .05 with no adjustments for multiple testing.|Mixed Models Analysis|Nesting of clinicians within site was adjusted for as a random effect.||||0.97|-0.51|0.54
71679984|NCT03634033|142877380|SUPERIORITY|Pre-/post-intervention comparison.|Mean Difference (Net)|-2.69|STANDARD_ERROR_OF_MEAN|1.63|<|0.01|TWO_SIDED|95.0|-3.96|-1.42|||t-test, 2 sided||Pre minus post|Pain||-1.42|-3.96|<.01
71679985|NCT03634033|142877380|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.9||0.58|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||ADL||4.91|-2.80|.58
71679986|NCT03634033|142877380|SUPERIORITY||Mean Difference (Net)|1.05|STANDARD_ERROR_OF_MEAN|1.29||0.44|TWO_SIDED|95.0|-2.8|4.91||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided|||IADL||4.91|-2.80|.44
71679987|NCT03634033|142877380|SUPERIORITY||Mean Difference (Net)|1.46|STANDARD_ERROR_OF_MEAN|1.63||0.38|TWO_SIDED|95.0|-1.85|4.77||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Depression||4.77|-1.85|.38
71679988|NCT03634033|142877381|SUPERIORITY|Self-efficacy|Mean Difference (Net)|-0.81|STANDARD_DEVIATION|0.11|<|0.01|TWO_SIDED|95.0|-1.02|-0.6||Threshold for statistical significance was .05 with no adjustments for multiple comparisons.|t-test, 2 sided||Pre minus post|Self-efficacy change baseline (month-0) to exit (month-4).||-0.60|-1.02|<0.01
71679989|NCT03634033|142877382|OTHER|Score on scale.|Mean|8.09|STANDARD_DEVIATION|1.6|<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<.01
71679990|NCT03634033|142877382|OTHER||Mean|7.55|STANDARD_DEVIATION|2.06|<|0.01|TWO_SIDED||||||t-test, 2 sided|||Satisfaction with format||||<.01
71820585|NCT02404493|143143176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.027|TWO_SIDED|95.0|-0.931|-0.069||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.069|-0.931|0.027
71820586|NCT02404493|143143177|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71679991|NCT03634033|142877382|OTHER||Mean|8.35|STANDARD_DEVIATION|1.5|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for caregiver||||<.01
71679992|NCT03634033|142877382|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Satisfaction with newness of content for clinician||||<.01
71679993|NCT03634033|142877382|OTHER||Mean|7.85|STANDARD_DEVIATION|1.92|<|0.01|TWO_SIDED||||||Difference from zero|||Intent to use new information||||<.01
71679994|NCT06366087|142877383|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.7|||||TWO_SIDED|90.0|0.67|0.724|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCinf lies within 80.00 to 125.00%.|||0.724|0.670|
71679995|NCT06366087|142877384|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.67|||||TWO_SIDED|90.0|0.64|0.697|||Mixed Models Analysis||Bioequivalence will be considered met if the 90% CI of the ratio for AUCt lies within 80.00 to 125.00%.|||0.697|0.640|
71679996|NCT06366087|142877385|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.11|||||TWO_SIDED|90.0|0.088|0.136|||Mixed Models Analysis|||||0.136|0.088|
71679997|NCT06366087|142877386|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.15|||||TWO_SIDED|90.0|0.12|0.189|||Mixed Models Analysis|||||0.189|0.120|
71679998|NCT06366087|142877387|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.26|||||TWO_SIDED|90.0|0.217|0.309|||Mixed Models Analysis|||||0.309|0.217|
71820587|NCT02404493|143143177|SUPERIORITY_OR_OTHER|||||||0.08||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.080
71679999|NCT06366087|142877388|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.36|||||TWO_SIDED|90.0|0.318|0.416|||Mixed Models Analysis|||||0.416|0.318|
71680000|NCT06366087|142877389|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.44|||||TWO_SIDED|90.0|0.396|0.492|||Mixed Models Analysis|||||0.492|0.396|
71680001|NCT06366087|142877390|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.532|0.608|||Mixed Models Analysis|||||0.608|0.532|
71902501|NCT05209932|143326777|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
71902502|NCT05209932|143326778|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED||||||ANCOVA|||||||0.05
71902503|NCT05209932|143326779|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.07||0.07|TWO_SIDED||||||ANCOVA|||||||0.07
71902504|NCT05209932|143326780|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
71680002|NCT06366087|142877391|OTHER|Estimation only. Estimates are back-transformed and based on a random effects linear model with log10 numeric response variable, adjusting for study route received, dosing sequence, and period, with a random effect for subject nested within dosing sequence.|Ratio of geometric least-square means|0.57|||||TWO_SIDED|90.0|0.524|0.62|||Mixed Models Analysis|||||0.620|0.524|
71680003|NCT04338269|142877422|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7844|TWO_SIDED|95.0|0.83|1.28|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.28|0.83|0.7844
71902505|NCT05209932|143326781|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71902506|NCT05209932|143326782|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.1||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
71902507|NCT05209932|143326783|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.09||0.01|TWO_SIDED||||||ANCOVA|||||||0.01
71902508|NCT05209932|143326784|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.04|TWO_SIDED||||||ANCOVA|||||||0.04
71902509|NCT05209932|143326785|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED||||||ANCOVA|||||||0.02
71902510|NCT05209932|143326786|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.13||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71680004|NCT04338269|142877422|OTHER||Hazard Ratio (HR)|1.04||||0.7195|TWO_SIDED|95.0|0.84|1.29|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|Cox Proportional Hazards Model||1.29|0.84|0.7195
71680005|NCT04338269|142877423|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|0.94||||0.6902|TWO_SIDED|95.0|0.7|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.70|0.6902
71680006|NCT04338269|142877423|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|0.96||||0.7853||95.0|0.71|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.71|0.7853
71902511|NCT05209932|143326787|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.43|TWO_SIDED||||||ANCOVA|||||||0.43
71902512|NCT05209932|143326788|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.14||0.12|TWO_SIDED||||||ANCOVA|||||||0.12
71902513|NCT05209932|143326789|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||ANCOVA|||||||0.03
71902514|NCT05209932|143326790|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.13||0.63|TWO_SIDED||||||ANCOVA|||||||0.63
71902515|NCT05209932|143326791|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|0.8||0.29|TWO_SIDED||||||ANCOVA|||||||0.29
71902516|NCT05209932|143326792|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|1.12||0.33|TWO_SIDED||||||ANCOVA|||||||0.33
71902517|NCT05209932|143326793|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|-2.92|STANDARD_ERROR_OF_MEAN|1.03||0.005|TWO_SIDED||||||ANCOVA|||||||0.005
71902518|NCT05209932|143326794|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.42|TWO_SIDED||||||ANCOVA|||||||0.42
71902519|NCT05209932|143326795|EQUIVALENCE|Testing the equivalence of the means using two-tailed test.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.97|TWO_SIDED||||||ANCOVA|||||||0.97
71902520|NCT03848221|143326796|EQUIVALENCE|||||||0.3|||||||ANOVA|||||||0.30
71902521|NCT03848221|143326797|EQUIVALENCE|||||||0.0002|||||||ANOVA|||||||0.0002
71902522|NCT01219959|143326842|SUPERIORITY||Mean Difference (Final Values)|0.6|||<|0.001|TWO_SIDED|95.0|0.2|0.9|||ANOVA|||Month 3||0.9|0.2|<0.001
71902523|NCT01219959|143326842|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.8|||ANOVA|||Month 6||0.8|0.1|0.006
71902524|NCT01219959|143326843|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.312|TWO_SIDED|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3||14.7|-4.7|0.312
71902525|NCT01219959|143326843|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.342|TWO_SIDED|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6||14.4|-5.0|0.342
71680007|NCT04338269|142877424|OTHER|Stratified Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.8037|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.27|0.83|0.8037
71902526|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3||0.9|0.1|0.010
71902527|NCT01219959|143326845|SUPERIORITY||Median Difference (Final Values)|0.3||||0.073|TWO_SIDED|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6||0.7|0|0.073
71902528|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.181|TWO_SIDED|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3||0.5|-0.1|0.181
71902529|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.593|TWO_SIDED|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6||0.4|-0.2|0.593
71902530|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.198|TWO_SIDED|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3||0|-0.2|0.198
71902531|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.298|TWO_SIDED|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6||0|-0.1|0.298
71902532|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3||0.6|0.2|<0.001
71902533|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.003|TWO_SIDED|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6||0.5|0.1|0.003
71902534|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3||1.3|0.4|<0.001
71902535|NCT01219959|143326845|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.002|TWO_SIDED|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6||1.1|0.3|0.002
71902536|NCT01219959|143326846|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.485|TWO_SIDED|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3||4.1|-8.6|0.485
71902537|NCT01219959|143326846|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.556|TWO_SIDED|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6||4.4|-8.2|0.556
71902538|NCT01219959|143326846|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.101|TWO_SIDED|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3||12.2|-1.1|0.101
71902539|NCT01219959|143326846|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.134|TWO_SIDED|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6||11.5|-1.5|0.134
71902540|NCT01219959|143326846|SUPERIORITY||Mean Difference (Final Values)|11.4||||0.004|TWO_SIDED|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3||19.2|3.6|0.004
71680008|NCT04338269|142877424|OTHER|Cox Proportional Hazards Model|Hazard Ratio (HR)|1.03||||0.7894|TWO_SIDED|95.0|0.83|1.27|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression.|||1.27|0.83|0.7894
71902541|NCT01219959|143326846|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.03|TWO_SIDED|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6||15.9|0.8|0.030
71902542|NCT01219959|143326847|SUPERIORITY||Mean Difference (Final Values)|-56.5||||0.655|TWO_SIDED|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3||191.7|-304.6|0.655
71902543|NCT01219959|143326847|SUPERIORITY||Mean Difference (Final Values)|-29.2||||0.811|TWO_SIDED|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6||210.5|-268.9|0.811
71902544|NCT01219959|143326847|SUPERIORITY||Mean Difference (Final Values)|441.3||||0.419|TWO_SIDED|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3||1513.1|-630.4|0.419
71902545|NCT01219959|143326847|SUPERIORITY||Mean Difference (Final Values)|121.8||||0.82|TWO_SIDED|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6||1171.5|-927.9|0.820
71902546|NCT01219959|143326848|SUPERIORITY||Mean Difference (Final Values)|-4.2||||0.721|TWO_SIDED|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3||19|-27.5|0.721
71902547|NCT01219959|143326848|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.247|TWO_SIDED|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6||36.4|-9.4|0.247
71902548|NCT01219959|143326849|SUPERIORITY||Mean Difference (Final Values)|0.89||||0.624|TWO_SIDED|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6||1.43|0.55|0.624
71902549|NCT01219959|143326850|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.338|TWO_SIDED|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3||1.8|-0.6|0.338
71902550|NCT01219959|143326850|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.029|TWO_SIDED|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6||2.5|0.1|0.029
71902551|NCT01219959|143326850|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.817|TWO_SIDED|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3||1.5|-1.9|0.817
71902552|NCT01219959|143326850|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.091|TWO_SIDED|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6||2.9|-0.2|0.091
71680009|NCT04338269|142877425|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|-3.68||||0.4306|TWO_SIDED|95.0|-12.45|5.1|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||5.10|-12.45|0.4306
71680010|NCT04338269|142877426|OTHER|Difference in Overall Response Rates|Odds Ratio (OR)|1.0||||0.9893|TWO_SIDED|95.0|0.7|1.43|||Cochran-Mantel-Haenszel||Odds ratio 95% CI was constructed using the Wald method. If at least one stratum has \<10 events at the time of analysis, the stratification factor containing the level with the smallest number of patients will be removed from the stratified analysis|||1.43|0.70|0.9893
71680011|NCT04338269|142877427|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.7||||0.0816|TWO_SIDED|95.0|0.47|1.05|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.05|0.47|0.0816
71820588|NCT02404493|143143177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.31||0.699|TWO_SIDED|95.0|-0.824|0.574||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.574|-0.824|0.699
71820589|NCT02404493|143143178|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820590|NCT02404493|143143178|SUPERIORITY_OR_OTHER|||||||0.058||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.058
71820591|NCT02404493|143143178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.711|TWO_SIDED|95.0|-0.607|0.857||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.857|-0.607|0.711
71820592|NCT02404493|143143179|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.006
71820593|NCT02404493|143143179|SUPERIORITY_OR_OTHER|||||||0.012||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.012
71852211|NCT01183013|143218585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.966||||0.0005|TWO_SIDED|95.0|1.604|5.485|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.485|1.604|0.0005
71820594|NCT02404493|143143179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.194||0.932|TWO_SIDED|95.0|-0.391|0.424||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.424|-0.391|0.932
71820595|NCT02404493|143143180|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
71820596|NCT02404493|143143180|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71852212|NCT01183013|143218585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.696||||0.0002||95.0|1.594|4.559|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||4.559|1.594|0.0002
71820597|NCT02404493|143143180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.228||0.767|TWO_SIDED|95.0|-0.41|0.547||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.547|-0.410|0.767
71820598|NCT02404493|143143181|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71820599|NCT02404493|143143181|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
71852213|NCT01183013|143218585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.017|||<|0.0001||95.0|2.348|6.873|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||6.873|2.348|<0.0001
71852214|NCT01183013|143218585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.521|||<|0.0001||95.0|4.63|15.681|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||15.681|4.630|<0.0001
71852215|NCT01183013|143218587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68||||0.4275|TWO_SIDED|95.0|-12.77|5.42|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||5.42|-12.77|0.4275
71680012|NCT04338269|142877427|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|0.72||||0.1099||95.0|0.49|1.08|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.08|0.49|0.1099
71680013|NCT04338269|142877428|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.04||||0.8354|TWO_SIDED|95.0|0.7|1.54|||Log Rank|Stratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.54|0.70|0.8354
71680014|NCT04338269|142877428|OTHER|Difference between Duration of Response (DOR) rates|Hazard Ratio (HR)|1.05||||0.8159|TWO_SIDED|95.0|0.71|1.55|||Log Rank|Unstratified|Hazard ratios were estimated by Cox regression. If at least one stratum has \<10 events at the time of analysis, the stratification factor that contains the level with the smallest number of patients will be removed from the stratified analysis.|||1.55|0.71|0.8159
71680015|NCT02715700|142877468|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.9|1.01||||||||1.01|0.90|
71820600|NCT02404493|143143181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.242||0.571|TWO_SIDED|95.0|-0.65|0.37||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.370|-0.650|0.571
71820601|NCT04039503|143143279|SUPERIORITY||LS Mean Difference|-1.66|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
71820602|NCT04039503|143143279|SUPERIORITY||LS Mean Difference|-1.65|||<|0.001|TWO_SIDED|95.0|-1.88|-1.43|||Mixed Models Analysis|||||-1.43|-1.88|<0.001
71820603|NCT04039503|143143280|SUPERIORITY||LS Mean Difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.52|-1.07|||Mixed Models Analysis|||||-1.07|-1.52|<0.001
71820604|NCT04039503|143143281|SUPERIORITY||LS Mean Difference|-7.8|||<|0.001|TWO_SIDED|95.0|-9.4|-6.3|||Mixed Models Analysis|||||-6.3|-9.4|<0.001
71820605|NCT04039503|143143281|SUPERIORITY||LS Mean Difference|-9.9|||<|0.001|TWO_SIDED|95.0|-11.5|-8.3|||Mixed Models Analysis|||||-8.3|-11.5|<0.001
71902553|NCT01219959|143326851|SUPERIORITY||Mean Difference (Final Values)|-10.2||||0.127|TWO_SIDED|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3||2.9|-23.3|0.127
71902554|NCT01219959|143326851|SUPERIORITY||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6||-4.3|-16.4|<0.001
71902555|NCT01219959|143326851|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.012|TWO_SIDED|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3||-0.1|-0.4|0.012
71902556|NCT01219959|143326851|SUPERIORITY||Mean Difference (Final Values)|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6||-0.1|-0.3|<0.001
71902557|NCT01219959|143326852|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.019|TWO_SIDED|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3||5.8|0.5|0.019
71902558|NCT01219959|143326852|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.019|TWO_SIDED|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6||5.6|0.5|0.019
71902559|NCT01219959|143326853|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.884|TWO_SIDED|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3||3.4|-3.9|0.884
71902560|NCT01219959|143326853|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.716|TWO_SIDED|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6||4.3|-3|0.716
71902561|NCT01219959|143326854|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.961|TWO_SIDED|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3||1.1|-1.2|0.961
71902562|NCT01219959|143326854|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.581|TWO_SIDED|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6||1.5|-0.8|0.581
71902563|NCT01219959|143326855|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.871|TWO_SIDED|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6||3.1|-3.7|0.871
71902564|NCT01219959|143326856|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.608|TWO_SIDED|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3||25|-14.7|0.608
71902565|NCT01219959|143326856|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.731|TWO_SIDED|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6||8.1|-11.5|0.731
71902566|NCT01219959|143326856|SUPERIORITY||Mean Difference (Final Values)|185.3||||0.377|TWO_SIDED|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3||598.1|-227.5|0.377
71902567|NCT01219959|143326856|SUPERIORITY||Mean Difference (Final Values)|-18.3||||0.854|TWO_SIDED|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6||177.8|-214.4|0.854
71902568|NCT01219959|143326857|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.412|TWO_SIDED|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3||0.07|-0.03|0.412
71902569|NCT01219959|143326857|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.485|TWO_SIDED|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6||0.03|-0.07|0.485
71902570|NCT01219959|143326858|SUPERIORITY||Mean Difference (Final Values)|2.18||||0.525|TWO_SIDED|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3||8.93|-4.56|0.525
71902571|NCT01219959|143326858|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.995|TWO_SIDED|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6||6.83|-6.79|0.995
71902572|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.526|TWO_SIDED|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3||3.91|-7.64|0.526
71680016|NCT02715700|142877469|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
71820606|NCT04039503|143143281|SUPERIORITY||LS Mean Difference|-12.6|||<|0.001|TWO_SIDED|95.0|-14.2|-11.0|||Mixed Models Analysis|||||-11.0|-14.2|<0.001
71680017|NCT02715700|142877470|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||||1.03|0.93|
71680018|NCT02715700|142877472|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.9|1.06||||||||1.06|0.90|
71680019|NCT02715700|142877473|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.86|1.1||||||||1.10|0.86|
71820607|NCT04039503|143143282|SUPERIORITY||Odds Ratio (OR)|37.77|||<|0.001|TWO_SIDED|95.0|15.23|93.7|||Regression, Logistic|||||93.70|15.23|<0.001
71820608|NCT04039503|143143282|SUPERIORITY||Odds Ratio (OR)|100.07|||<|0.001|TWO_SIDED|95.0|30.02|333.62|||Regression, Logistic|||||333.62|30.02|<0.001
71820609|NCT04039503|143143282|SUPERIORITY||Odds Ratio (OR)|43.31|||<|0.001|TWO_SIDED|95.0|16.92|110.83|||Regression, Logistic|||||110.83|16.92|<0.001
71820610|NCT04039503|143143283|SUPERIORITY||LS Mean Difference|-22.5|||<|0.001|TWO_SIDED|95.0|-29.5|-15.4|||Mixed Models Analysis|||||-15.4|-29.5|<0.001
71820611|NCT04039503|143143283|SUPERIORITY||LS Mean Difference|-29.0|||<|0.001|TWO_SIDED|95.0|-36.0|-22.0|||Mixed Models Analysis|||||-22.0|-36.0|<0.001
71820612|NCT04039503|143143283|SUPERIORITY||LS Mean Difference|-28.8|||<|0.001|TWO_SIDED|95.0|-35.9|-21.6|||Mixed Models Analysis|||||-21.6|-35.9|<0.001
71820613|NCT04039503|143143285|SUPERIORITY||Odds Ratio (OR)|17.15|||<|0.001|TWO_SIDED|95.0|7.55|38.93|||Regression, Logistic|||||38.93|7.55|<0.001
71820614|NCT04039503|143143285|SUPERIORITY||Odds Ratio (OR)|27.24|||<|0.001|TWO_SIDED|95.0|11.87|62.55|||Regression, Logistic|||||62.55|11.87|<0.001
71820615|NCT04039503|143143285|SUPERIORITY||Odds Ratio (OR)|79.61|||<|0.001|TWO_SIDED|95.0|32.76|193.44|||Regression, Logistic|||||193.44|32.76|<0.001
71820616|NCT04039503|143143286|SUPERIORITY||Estimate Difference|-35.4|||||TWO_SIDED|95.0|-46.0|-22.8||||||||-22.8|-46.0|
71820617|NCT04039503|143143286|SUPERIORITY||Estimate Difference|-38.2|||||TWO_SIDED|95.0|-48.3|-26.1||||||||-26.1|-48.3|
71820618|NCT04039503|143143286|SUPERIORITY||Estimate Difference|-49.3|||||TWO_SIDED|95.0|-57.7|-39.4||||||||-39.4|-57.7|
71820619|NCT04039503|143143289|SUPERIORITY||Odds Ratio (OR)|12.22|||<|0.001|TWO_SIDED|95.0|3.93|38.0|||Regression, Logistic|||||38.00|3.93|<0.001
71820620|NCT04039503|143143289|SUPERIORITY||Odds Ratio (OR)|32.36|||<|0.001|TWO_SIDED|95.0|10.52|99.49|||Regression, Logistic|||||99.49|10.52|<0.001
71820621|NCT04039503|143143289|SUPERIORITY||Odds Ratio (OR)|56.26|||<|0.001|TWO_SIDED|95.0|18.27|173.26|||Regression, Logistic|||||173.26|18.27|<0.001
71820622|NCT04834362|143143297|OTHER|||||||0.677|||||||t-test, 2 sided|||||||0.677
71820623|NCT04834362|143143298|OTHER|||||||0.053|||||||t-test, 2 sided|||||||0.053
71820624|NCT04834362|143143299|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
71820625|NCT04834362|143143300|OTHER|||||||0.729|||||||Chi-squared|||||||0.729
71820626|NCT02555371|143143309|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.004|TWO_SIDED|95.0|0.45|0.86|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.86|0.45|0.004
71820627|NCT02555371|143143310|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.|||0.24|0.15|<0.001
71820628|NCT02555371|143143310|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.12|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.|||0.20|0.12|<0.001
71820629|NCT02555371|143143310|SUPERIORITY||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.|||0.24|0.15|<0.001
71820630|NCT02555371|143143310|SUPERIORITY||Ratio|0.16|||<|0.001|TWO_SIDED|95.0|0.13|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.|||0.20|0.13|<0.001
71820631|NCT02555371|143143311|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||0.88|0.49|0.005
71820632|NCT02555371|143143312|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.57|TWO_SIDED|95.0|0.5|3.51|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.|||3.51|0.50|0.570
71820633|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.99|1.43|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.||1.43|0.99|
71820634|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.01|||||TWO_SIDED|95.0|0.84|1.21|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.||1.21|0.84|
71820635|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||TWO_SIDED|95.0|0.93|1.51|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.||1.51|0.93|
71820636|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.83|||||TWO_SIDED|95.0|0.66|1.06|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.||1.06|0.66|
71820637|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.26|||||TWO_SIDED|95.0|0.97|1.64|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.||1.64|0.97|
71680020|NCT02715700|142877474|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||TWO_SIDED|90.0|0.91|1.04||||||||1.04|0.91|
71680021|NCT02715700|142877476|OTHER|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.9|1.03||||||||1.03|0.90|
71680022|NCT02715700|142877477|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||TWO_SIDED|90.0|0.87|1.05||||||||1.05|0.87|
71680023|NCT02715700|142877478|OTHER|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||TWO_SIDED|90.0|0.92|1.03||||||||1.03|0.92|
71680024|NCT04166591|142877480|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||binomial test|||||||<0.01
71852216|NCT01183013|143218587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.84||||0.6839|TWO_SIDED|95.0|-10.69|7.02|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||7.02|-10.69|0.6839
71852217|NCT01183013|143218587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.1466|TWO_SIDED|95.0|-15.29|2.28|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||2.28|-15.29|0.1466
71852218|NCT01183013|143218587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.38||||0.0002|TWO_SIDED|95.0|-26.35|-8.41|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-8.41|-26.35|0.0002
71852219|NCT01183013|143218587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.87|||<|0.0001|TWO_SIDED|95.0|-34.77|-16.98|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-16.98|-34.77|<0.0001
71852220|NCT01183013|143218587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||<|0.0001|TWO_SIDED|95.0|-42.57|-24.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-24.89|-42.57|<0.0001
71852221|NCT01183013|143218589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.61||||0.0057|TWO_SIDED|95.0|-62.42|-10.8|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-10.80|-62.42|0.0057
71852222|NCT01183013|143218589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.94||||0.7021||95.0|-30.39|20.51|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||20.51|-30.39|0.7021
71852223|NCT01183013|143218589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.8932|TWO_SIDED|95.0|-27.95|24.38|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||24.38|-27.95|0.8932
71852224|NCT01183013|143218589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.2706|TWO_SIDED|95.0|-43.6|12.3|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||12.30|-43.60|0.2706
71852225|NCT01183013|143218589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.33||||0.0126|TWO_SIDED|95.0|-64.78|-7.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-7.89|-64.78|0.0126
71852226|NCT01183013|143218589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.16||||0.0167|TWO_SIDED|95.0|-60.23|-6.08|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||-6.08|-60.23|0.0167
71680025|NCT04166591|142877480|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71680026|NCT04166591|142877480|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71852227|NCT01183013|143218591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.649||||0.3052||95.0|0.284|1.482|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.482|0.284|0.3052
71852228|NCT01183013|143218591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.456||||0.0844|TWO_SIDED|95.0|0.187|1.112|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.112|0.187|0.0844
71852229|NCT01183013|143218591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.443||||0.1561|TWO_SIDED|95.0|0.143|1.365|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||1.365|0.143|0.1561
71852230|NCT01183013|143218591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.368||||0.0146||95.0|0.165|0.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.821|0.165|0.0146
71852231|NCT01183013|143218591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.238||||0.0009||95.0|0.102|0.557|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.557|0.102|0.0009
71680027|NCT04166591|142877480|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71680028|NCT04166591|142877481|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71820638|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.82|||||TWO_SIDED|95.0|0.63|1.07|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.||1.07|0.63|
71820639|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.24|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.||1.24|0.89|
71852232|NCT01183013|143218591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.0002||95.0|0.05|0.397|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.||0.397|0.050|0.0002
71852233|NCT01014013|143218598|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy endpoint was based on the proportion of patients who had a favorable microbiological response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-0.8|STANDARD_DEVIATION|10.9||||95.0|-11.7|10.2||||||||10.2|-11.7|
71852234|NCT01014013|143218600|NON_INFERIORITY_OR_EQUIVALENCE|The secondary efficacy endpoint was based on the proportion of patients who had a favorable clinical response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-1.7|STANDARD_ERROR_OF_MEAN|4.9||||95.0|-6.6|3.2||||||||3.2|-6.6|
71852235|NCT02100189|143218612|SUPERIORITY_OR_OTHER||Sensitivity|13.3|STANDARD_ERROR_OF_MEAN|0.062|||TWO_SIDED|95.0|3.76|30.72|||Sensitivity||Exact Binomial confidence interval.|||30.72|3.76|
71852236|NCT02100189|143218613|SUPERIORITY_OR_OTHER||Specificity|94.7|STANDARD_ERROR_OF_MEAN|0.051|||TWO_SIDED|95.0|73.97|99.87|||Specificity||Exact binomial confidence interval|||99.87|73.97|
71852237|NCT02213458|143218622|SUPERIORITY||Slope|0.539||||0.04|TWO_SIDED|95.0|0.259|1.337|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||Linear mixed effects model||1.337|.259|0.04
71852238|NCT02213458|143218623|SUPERIORITY||Slope|-0.138||||0.05|TWO_SIDED|95.0|-0.295|-0.02|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-.020|-.295|.05
71852239|NCT02213458|143218624|SUPERIORITY||Slope|-1.902||||0.07|TWO_SIDED|95.0|-3.885|-0.08|||Mixed Models Analysis|Linear mixed model controlling for dementia severity (QDRS)||||-0.080|-3.885|0.07
71852240|NCT02213458|143218626|SUPERIORITY||Slope|-1.143||||0.03|TWO_SIDED|95.0|-2.154|-0.132|||Mixed Models Analysis|||||-0.132|-2.154|0.03
71852241|NCT02213458|143218627|SUPERIORITY||Slope|0.635||||0.11|TWO_SIDED|95.0|-0.135|1.405|||Mixed Models Analysis|Controlling for dementia severity (QDRS)||||1.405|-0.135|0.11
71852242|NCT04799587|143218650|SUPERIORITY|Sample size for the study was determined by assuming a baseline rate of 33% of IONV and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD. A two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100. Statistical analyses were two-sided, and a P\<0.05 was required to reject the null hypothesis.||||||0.94|||||||Chi-squared|||The incidence of nausea and vomiting and the number of episodes between the P6 acupressure and sham acupressure groups were compared using a chi-square statistic (nominal data) or the Wilcoxon test (continuous data).||||.94
71852243|NCT04799587|143218651|SUPERIORITY|||||||0.95|||||||Chi-squared|||The sample size for the study was determined by assuming a baseline rate of 33% of intraoperative nausea and vomiting and that there will be a relative decrease of 50% in the group that receives P6 acupressure during CD.20 Using a two-sided Fisher's Exact Test, with a significance level of 0.05, group sizes of 98 are needed to achieve 80% power to detect a difference between the group proportions of 0.18. Group sizes were rounded up to 100||||.95
71852244|NCT00515281|143218678|SUPERIORITY|||||||0.017|||||||Chi-squared|||||||0.017
71902573|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.779|TWO_SIDED|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6||6.68|-5.01|0.779
71852245|NCT00515281|143218679|SUPERIORITY|||||||0.288|||||||Chi-squared|||||||0.288
71852246|NCT00515281|143218680|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71852247|NCT00515281|143218681|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
71852248|NCT00515281|143218682|SUPERIORITY|||||||0.72|||||||Chi-squared|||||||0.72
71852249|NCT00515281|143218683|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71852250|NCT00515281|143218684|SUPERIORITY|||||||0.28|||||||Chi-squared|||||||0.28
71852251|NCT06312566|143218692|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 92.016% CI limits for Cmax,ss was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9726|||||TWO_SIDED|92.016|0.9257|1.022|||Linear mixed model analysis|||||1.022|0.9257|
71852252|NCT06312566|143218693|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(tau) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.9999|||||TWO_SIDED|92.016|0.9881|1.012||||||||1.012|0.9881|
71852253|NCT04736472|143218700|SUPERIORITY|||||||0.224|||||||Fisher Exact|||Severe TRAEs||||.224
71852254|NCT04736472|143218700|SUPERIORITY|||||||0.025|||||||Fisher Exact|||Severe TRAEs||||.025
71852255|NCT02971683|143218713|SUPERIORITY||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.9|3.5|||Regression, Logistic|||||3.5|0.9|0.083
71680029|NCT04166591|142877481|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.||||||0.12|||||||Binomial test|||||||0.12
71902574|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|-2.95||||0.246|TWO_SIDED|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3||2.04|-7.95|0.246
71680030|NCT04166591|142877481|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71902575|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.78|TWO_SIDED|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6||4.34|-5.78|0.780
71902576|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.885|TWO_SIDED|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3||6.04|-5.22|0.885
71902577|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|4.41||||0.128|TWO_SIDED|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6||10.10|-1.28|0.128
71902578|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|1.07||||0.701|TWO_SIDED|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3||6.54|-4.40|0.701
71902579|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|7.21||||0.01|TWO_SIDED|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6||12.73|1.70|0.010
71902580|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.934|TWO_SIDED|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3||5.03|-4.63|0.934
71902581|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|3.13||||0.209|TWO_SIDED|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6||8.01|-1.75|0.209
71902582|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.585|TWO_SIDED|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3||8.68|-4.90|0.585
71902583|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.641|TWO_SIDED|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6||8.47|-5.22|0.641
71902584|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.586|TWO_SIDED|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3||3.90|-6.89|0.586
71902585|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.906|TWO_SIDED|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6||5.14|-5.79|0.906
71902586|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.97|TWO_SIDED|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3||4.75|-4.93|0.970
71902587|NCT01219959|143326859|SUPERIORITY||Mean Difference (Final Values)|2.38||||0.34|TWO_SIDED|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6||7.28|-2.52|0.340
71902588|NCT01219959|143326860|SUPERIORITY||Mean Difference (Final Values)|24.6||||0.495|TWO_SIDED|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6||96|-46.9|0.495
71902589|NCT01219959|143326860|SUPERIORITY||Mean Difference (Final Values)|55.4||||0.081|TWO_SIDED|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6||117.8|-7|0.081
71902590|NCT01219959|143326861|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.626|TWO_SIDED|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6||31.9|-19.3|0.626
71680031|NCT04166591|142877481|OTHER|The primary statistical analysis involves asking whether children look at the target significantly more than chance levels. Binomial tests are used to see if the number of children who do so is significantly greater than would be expected by chance.|||||<|0.01|||||||Binomial test|||||||<0.01
71680032|NCT02730377|142877482|SUPERIORITY||||||<|0.0001|||||||Log Rank|||Test for no treatment difference is based on using a generalised log-rank test for interval censored failure time data.||||<.0001
71902591|NCT01219959|143326861|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.486|TWO_SIDED|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6||30.1|-14.5|0.486
71902592|NCT01219959|143326862|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.832|TWO_SIDED|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6||23.4|-18.9|0.832
71902593|NCT01219959|143326862|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.82|TWO_SIDED|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6||23.1|-18.3|0.820
71902594|NCT01219959|143326863|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.955|TWO_SIDED|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6||6.5|-6.9|0.955
71902595|NCT01728584|143326864|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|1.09||||0.026|TWO_SIDED|95.0|0.13|2.04|||ANCOVA|Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)|Difference is deep versus standard NMB|Primary hypothesis - deep NMB improves surgeon's overall satisfaction with the surgical conditions compared to standard NMB||2.04|0.13|0.026
71902596|NCT01728584|143326864|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.02|||<|0.001|TWO_SIDED|95.0|-3.99|-2.05|||ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is low versus standard pressure|||-2.05|-3.99|<0.001
71680033|NCT02111746|142877505|SUPERIORITY|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||||||0.934
71902597|NCT01728584|143326865|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|3.66|||||TWO_SIDED|95.0|2.3|5.02|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||5.02|2.30|
71680034|NCT02111746|142877506|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
71820640|NCT01755689|143143364|NON_INFERIORITY|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||ANCOVA|||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.||1.12|0.80|
71820641|NCT01755689|143143365|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|0.97|||||TWO_SIDED|95.0|0.81|1.15|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.||1.15|0.81|
71820642|NCT01755689|143143365|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.09|||||TWO_SIDED|95.0|0.92|1.29|||ANCOVA|||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.||1.29|0.92|
71820643|NCT01755689|143143365|NON_INFERIORITY|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.2|||||TWO_SIDED|95.0|1.01|1.43|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.||1.43|1.01|
71820644|NCT01755689|143143365|NON_INFERIORITY|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.19|||||TWO_SIDED|95.0|1.0|1.41|||ANCOVA|||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.||1.41|1.00|
71820645|NCT01755689|143143366|NON_INFERIORITY|For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-2.88|||||TWO_SIDED|95.0|-6.9|0.81||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.||0.81|-6.90|
71820646|NCT01755689|143143366|NON_INFERIORITY|For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-0.4|||||TWO_SIDED|95.0|-2.23|1.08||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.||1.08|-2.23|
71820647|NCT01755689|143143367|NON_INFERIORITY|For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.53|||||TWO_SIDED|95.0|1.25|1.87|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.||1.87|1.25|
71820648|NCT01755689|143143367|NON_INFERIORITY|For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.65|||||TWO_SIDED|95.0|1.42|1.93|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.||1.93|1.42|
71902598|NCT01728584|143326865|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.44|||||TWO_SIDED|95.0|-1.8|0.91|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||0.91|-1.80|
71902599|NCT01728584|143326865|SUPERIORITY_OR_OTHER||Difference in LS Means|1.96|||||TWO_SIDED|95.0|0.57|3.36|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.36|0.57|
71902600|NCT01728584|143326865|SUPERIORITY_OR_OTHER||Difference in LS Means|-4.1|||||TWO_SIDED|95.0|-5.42|-2.78|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-2.78|-5.42|
71902601|NCT01728584|143326865|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.7|||||TWO_SIDED|95.0|-3.01|-0.38|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||-0.38|-3.01|
71902602|NCT01728584|143326865|SUPERIORITY_OR_OTHER||Difference in LS Means|2.41|||||TWO_SIDED|95.0|1.08|3.74|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI||3.74|1.08|
71902603|NCT01728584|143326866|SUPERIORITY_OR_OTHER||Difference in LS Means|0.35||||0.148|TWO_SIDED|95.0|-0.13|0.84|||ANOVA|Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon|Difference is deep versus standard NMB|||0.84|-0.13|0.148
71902604|NCT01728584|143326866|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.17||||0.494|TWO_SIDED|95.0|-0.67|0.33||To control for multiple testing, this difference was formally tested only if comparison of surgeon's overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.|ANOVA|ANOVA model included factors depth of NMB, level of pressure, gender and surgeon|Difference is low versus standard pressure|Key secondary hypothesis - low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure||0.33|-0.67|0.494
71902605|NCT01728584|143326867|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.2|||||TWO_SIDED|95.0|-0.92|0.52|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.52|-0.92|
71902606|NCT01728584|143326867|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.65|||||TWO_SIDED|95.0|-1.27|-0.02|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||-0.02|-1.27|
71680035|NCT02111746|142877507|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71680036|NCT02111746|142877508|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
71852256|NCT04206501|143218727|SUPERIORITY|||||||0.064||||||The rate of change in HF medications (beta-blocker, diuretic, and Sacubitril/Valsartan) was compared betweenICM Guidedand usual care control group using chi-square analysis.|Chi-squared|||Due to the unexpected low enrollment during COVID pandemic, we aimed to primarily focus the limited analysis/description on the primary endpoint and exploratory analysis related to QOL||||0.064
71852257|NCT01292005|143218734|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.62
71852258|NCT01292005|143218734|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||1.0
71852259|NCT01292005|143218735|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.72
71852260|NCT01292005|143218735|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.50
71852261|NCT01292005|143218736|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.58
71852262|NCT01292005|143218736|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.80
71852263|NCT01292005|143218737|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p\<0.05 was considered statistically significant.||||0.90
71852264|NCT01292005|143218737|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p\<0.05 was considered statistically significant.||||0.56
71852265|NCT01292005|143218738|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.09
71852266|NCT01292005|143218739|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Wilcoxon (Mann-Whitney)|||p\<0.05 was considered statistically significant.||||0.22
71852267|NCT01292005|143218740|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Comparison between arms for length of hospitalization \> 4 days. P \< 0.05 was considered statistically significant.||||0.04
71852268|NCT01292005|143218740|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Comparison was for length of hospitalization \>10 days. P \< 0.05 was considered statistically significant.||||0.03
71852269|NCT01292005|143218741|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||P \< 0.05 was considered statistically significant.||||0.06
71852270|NCT01292005|143218742|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.03
71852271|NCT01292005|143218743|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||P \< 0.05 was considered statistically significant.||||0.04
71852272|NCT00936065|143218751|SUPERIORITY_OR_OTHER|||||||0.0672|TWO_SIDED||||||Fisher Exact|||Overall treatment difference||||0.0672
71852273|NCT00936065|143218752|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 2||||1.0000
71852274|NCT00936065|143218752|SUPERIORITY_OR_OTHER|||||||0.0229|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 4||||0.0229
71852275|NCT00936065|143218752|SUPERIORITY_OR_OTHER|||||||0.0256|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 8||||0.0256
71852276|NCT00936065|143218752|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 12||||0.0004
71902607|NCT01728584|143326867|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.15|||||TWO_SIDED|95.0|-0.84|0.53|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.53|-0.84|
71902608|NCT01728584|143326867|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.45|||||TWO_SIDED|95.0|-1.15|0.26|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon||0.26|-1.15|
71902609|NCT01728584|143326867|SUPERIORITY_OR_OTHER||Difference in LS Means|0.05|||||TWO_SIDED|95.0|-0.69|0.78|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||0.78|-0.69|
71902610|NCT01728584|143326867|SUPERIORITY_OR_OTHER||Difference in LS Means|0.49|||||TWO_SIDED|95.0|-0.17|1.16|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon||1.16|-0.17|
71902611|NCT01728584|143326868|SUPERIORITY_OR_OTHER||Difference in LS Means|0.91||||0.063|TWO_SIDED|95.0|-0.05|1.87||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.87|-0.05|0.063
71902612|NCT01728584|143326869|SUPERIORITY_OR_OTHER||Difference in LS Means|0.82||||0.004|TWO_SIDED|95.0|0.27|1.37||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.37|0.27|0.004
71902613|NCT01728584|143326870|SUPERIORITY_OR_OTHER||Difference in LS Means|1.12||||0.006|TWO_SIDED|95.0|0.32|1.92||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.92|0.32|0.006
71902614|NCT01728584|143326871|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.61||||0.073|TWO_SIDED|95.0|-1.27|0.06||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||0.06|-1.27|0.073
71902615|NCT01728584|143326872|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74||||0.009|TWO_SIDED|95.0|0.19|1.28||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB|||1.28|0.19|0.009
71852277|NCT00936065|143218752|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 18||||0.0105
71852278|NCT00936065|143218752|SUPERIORITY_OR_OTHER|||||||0.0366|TWO_SIDED||||||Fisher Exact|||Overall treatment difference Week 24||||0.0366
71852279|NCT00936065|143218753|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||1.0000
71852280|NCT00936065|143218753|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.3230
71852281|NCT00936065|143218753|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||1.0000
71820649|NCT01755689|143143367|NON_INFERIORITY|For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||ANCOVA|||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.||1.61|1.20|
71820650|NCT03699124|143143409|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|0.936|||||TWO_SIDED|95.0|0.816|1.073||||||||1.073|0.816|
71820651|NCT03699124|143143409|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.115|||||TWO_SIDED|95.0|0.967|1.287||||||||1.287|0.967|
71820652|NCT03699124|143143409|EQUIVALENCE|Equivalence between two lot groups is demonstrated if the confidence interval of the ratio of the GMTs lies within the interval \[½, 2\]. For the trial to be successful, all three lot group comparisons must be equivalent by this definition.|GMT Ratio|1.044|||||TWO_SIDED|95.0|0.915|1.191||||||||1.191|0.915|
71820653|NCT03405662|143143431|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
71820654|NCT03405662|143143432|SUPERIORITY|||||||0.29|||||||non-parametric Kolmogorov-Smirnov test|||||||0.29
71820655|NCT03405662|143143433|SUPERIORITY|||||||0.07|||||||non-parametric Kolmogorov-Smirnov test|||||||0.07
71820656|NCT03405662|143143434|SUPERIORITY|||||||0.23|||||||non-parametric Kolmogorov-Smirnov test|||||||0.23
71820657|NCT03405662|143143435|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
71820658|NCT03405662|143143436|SUPERIORITY|||||||0.13|||||||non-parametric Kolmogorov-Smirnov test|||||||0.13
71820659|NCT03405662|143143437|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
71820660|NCT03405662|143143438|SUPERIORITY|||||||0.68|||||||non-parametric Kolmogorov-Smirnov test|||||||0.68
71820661|NCT03405662|143143439|SUPERIORITY|||||||0.86|||||||non-parametric Kolmogorov-Smirnov test|||||||0.86
71820662|NCT03405662|143143440|SUPERIORITY|||||||0.32|||||||non-parametric Kolmogorov-Smirnov test|||||||0.32
71902616|NCT05906732|143326884|SUPERIORITY||LS Mean|-9.6||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0030
71820663|NCT01558674|143143490|SUPERIORITY_OR_OTHER||Difference in Least Squares (LS) Means|-98.5|||||TWO_SIDED|95.0|-138.0|-59.1|||Linear mixed effect model||8-mg MK-7145 LS Mean minus Furosemide LS Mean|||-59.1|-138.0|
71820664|NCT01558674|143143492|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (GMR)|1.1|||||TWO_SIDED|90.0|0.99|1.22|||Mixed Linear Effects Model||GMR = Geometric mean (GM) MK-7145 8 mg divided by GM Furosemide|||1.22|0.99|
71820665|NCT04147260|143143504|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.068|||TWO_SIDED|90.0|-0.03|0.2|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.20|-0.03|
71820666|NCT04147260|143143504|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|90.0|-0.07|0.16|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.16|-0.07|
71820667|NCT04147260|143143504|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.055||0.572|TWO_SIDED|90.0|-0.14|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.14|0.572
71820668|NCT04147260|143143504|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.075||0.315|TWO_SIDED|90.0|-0.07|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.07|0.315
71820669|NCT04147260|143143504|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.059||0.286|TWO_SIDED|90.0|-0.18|0.05||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.05|-0.18|0.286
71902617|NCT05906732|143326885|SUPERIORITY||LS Mean|-6.5||||0.0266|TWO_SIDED||||||Mixed Models Analysis|||||||0.0266
71902618|NCT05906732|143326886|SUPERIORITY||LS Mean|-7.8||||0.0067|TWO_SIDED||||||Mixed Models Analysis|||||||0.0067
71680037|NCT02111746|142877509|SUPERIORITY|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||||||0.449
71680038|NCT02111746|142877510|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71820670|NCT04147260|143143504|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.077||0.057|TWO_SIDED|90.0|0.0|0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.31|0.00|0.057
71820671|NCT04147260|143143505|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.153|||TWO_SIDED|90.0|-0.02|0.49|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.49|-0.02|
71820672|NCT04147260|143143505|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.124|||TWO_SIDED|90.0|-0.2|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.20|
71820673|NCT04147260|143143505|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.102|<|0.001|TWO_SIDED|90.0|-0.72|-0.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.31|-0.72|<0.001
71820674|NCT04147260|143143505|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|90.0|0.24|0.8||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.80|0.24|<0.001
71820675|NCT04147260|143143505|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.132||0.01|TWO_SIDED|90.0|-0.62|-0.09||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-0.09|-0.62|0.010
71820676|NCT04147260|143143505|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.59|STANDARD_ERROR_OF_MEAN|0.173||0.001|TWO_SIDED|90.0|0.24|0.93||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.93|0.24|0.001
71820677|NCT04147260|143143506|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.044|||TWO_SIDED|90.0|-0.05|0.1|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.10|-0.05|
71820678|NCT04147260|143143506|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.038||0.998|TWO_SIDED|90.0|-0.08|0.08||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.08|-0.08|0.998
71820679|NCT04147260|143143506|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.618|TWO_SIDED|90.0|-0.08|0.13||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.13|-0.08|0.618
71820680|NCT04147260|143143506|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|90.0|-0.1|0.23|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.23|-0.10|
71820681|NCT04147260|143143506|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.081||0.451|TWO_SIDED|90.0|-0.1|0.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.23|-0.10|0.451
71820682|NCT04147260|143143506|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11||1|TWO_SIDED|90.0|-0.22|0.22||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.22|-0.22|1.000
71852282|NCT00936065|143218753|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||1.0000
71852283|NCT00936065|143218754|SUPERIORITY_OR_OTHER|||||||0.3103|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.3103
71852284|NCT00936065|143218754|SUPERIORITY_OR_OTHER|||||||0.4763|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.4763
71852285|NCT00936065|143218754|SUPERIORITY_OR_OTHER|||||||0.1961|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1961
71852286|NCT00936065|143218754|SUPERIORITY_OR_OTHER|||||||0.0272|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0272
71680039|NCT02111746|142877511|SUPERIORITY|||||||0.774|||||||Wilcoxon (Mann-Whitney)|||||||0.774
71680040|NCT02111746|142877512|SUPERIORITY|||||||0.188|||||||Wilcoxon (Mann-Whitney)|||||||0.188
71680041|NCT02111746|142877513|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
71688687|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 8 (-0.75 hrs post-dose)||0.45|0.25|<0.001
71820683|NCT04147260|143143507|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.152|||TWO_SIDED|90.0|-0.15|0.36|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.36|-0.15|
71902619|NCT05906732|143326887|SUPERIORITY||LS Mean|-3.9||||0.1106|TWO_SIDED||||||Mixed Models Analysis|||||||0.1106
71902620|NCT05906732|143326888|SUPERIORITY||LS Mean|-4.2||||0.0908|TWO_SIDED||||||Mixed Models Analysis|||||||0.0908
71902621|NCT05906732|143326889|SUPERIORITY||LS Mean|-1.2||||0.4038|TWO_SIDED||||||Mixed Models Analysis|||||||0.4038
71902622|NCT05906732|143326890|SUPERIORITY||LS Mean|1.5||||0.6255|TWO_SIDED||||||Mixed Models Analysis|||||||0.6255
71902623|NCT05906732|143326891|SUPERIORITY||LS Mean|0.2||||0.514|TWO_SIDED||||||Mixed Models Analysis|||||||0.5140
71902624|NCT05906732|143326892|SUPERIORITY||LS Mean|0.8||||0.5675|TWO_SIDED||||||Mixed Models Analysis|||||||0.5675
71902625|NCT05906732|143326893|SUPERIORITY||LS Mean|3.4||||0.764|TWO_SIDED||||||Mixed Models Analysis|||||||0.7640
71820684|NCT04147260|143143507|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.131||0.446|TWO_SIDED|90.0|-0.16|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.16|0.446
71902626|NCT05906732|143326894|SUPERIORITY||LS Mean|-2.8||||0.2437|TWO_SIDED||||||Mixed Models Analysis|||||||.2437
71902627|NCT05906732|143326895|SUPERIORITY||LS Mean|-0.8||||0.4229|TWO_SIDED||||||Mixed Models Analysis|||||||0.4229
71902628|NCT05906732|143326896|SUPERIORITY||LS Mean|-0.1||||0.4887|TWO_SIDED||||||Mixed Models Analysis|||||||0.4887
71902629|NCT05906732|143326897|SUPERIORITY||LS Mean|-3.1||||0.2042|TWO_SIDED||||||Mixed Models Analysis|||||||0.2042
71902630|NCT05906732|143326898|SUPERIORITY||Mean Difference (Net)|-2.2||||0.2644|TWO_SIDED||||||Mixed Models Analysis|||||||0.2644
71902631|NCT05906732|143326916|SUPERIORITY||Mean Difference (Net)|4.28||||0.3169|TWO_SIDED||||||t-test, 2 sided|||||||0.3169
71902632|NCT05906732|143326917|SUPERIORITY||Mean Difference (Net)|6.78||||0.1066|TWO_SIDED||||||t-test, 2 sided|||||||0.1066
71902633|NCT05906732|143326918|SUPERIORITY||Mean Difference (Net)|-16.06||||0.0443|TWO_SIDED||||||t-test, 2 sided|||||||0.0443
71902634|NCT05906732|143326919|SUPERIORITY||Mean Difference (Net)|-9.06||||0.0815|TWO_SIDED||||||t-test, 2 sided|||||||0.0815
71902635|NCT05906732|143326920|SUPERIORITY||Mean Difference (Net)|-10.67||||0.0137|TWO_SIDED||||||t-test, 2 sided|||||||0.0137
71902636|NCT05906732|143326921|SUPERIORITY||Mean Difference (Net)|-4.0||||0.3539|TWO_SIDED||||||t-test, 2 sided|||||||0.3539
71902637|NCT05906732|143326922|SUPERIORITY||Mean Difference (Net)|9.78||||0.1377|TWO_SIDED||||||t-test, 2 sided|||||||0.1377
71902638|NCT05906732|143326923|SUPERIORITY||Mean Difference (Net)|-2.69||||0.6184|TWO_SIDED||||||t-test, 2 sided|||||||0.6184
71902639|NCT05906732|143326924|SUPERIORITY||Mean Difference (Net)|3.17||||0.6627|TWO_SIDED||||||t-test, 2 sided|||||||0.6627
71902640|NCT05906732|143326925|SUPERIORITY||Mean Difference (Net)|5.78||||0.5276|TWO_SIDED||||||t-test, 2 sided|||||||0.5276
71902641|NCT05906732|143326926|SUPERIORITY||Mean Difference (Net)|15.17||||0.0399|TWO_SIDED||||||t-test, 2 sided|||||||0.0399
71902642|NCT05906732|143326927|SUPERIORITY||Mean Difference (Net)|13.56||||0.0747|TWO_SIDED||||||t-test, 2 sided|||||||0.0747
71902643|NCT05906732|143326928|SUPERIORITY|||||||0.9584|||||||t-test, 2 sided|||||||0.9584
71902644|NCT05906732|143326929|SUPERIORITY||Mean Difference (Net)|5.72||||0.6531|TWO_SIDED||||||t-test, 2 sided|||||||0.6531
71902645|NCT05906732|143326930|SUPERIORITY||Mean Difference (Net)|15.61||||0.0482|TWO_SIDED||||||t-test, 2 sided|||||||0.0482
71902646|NCT05906732|143326931|SUPERIORITY||Mean Difference (Net)|17.22||||0.0667|TWO_SIDED||||||t-test, 2 sided|||||||0.0667
71902647|NCT05906732|143326932|SUPERIORITY||Mean Difference (Net)|-37.0||||0.0131|TWO_SIDED||||||t-test, 2 sided|||||||0.0131
71902648|NCT05906732|143326933|SUPERIORITY||Mean Difference (Net)|-32.36||||0.0141|TWO_SIDED||||||t-test, 2 sided|||||||0.0141
71902649|NCT05906732|143326934|SUPERIORITY||Mean Difference (Net)|-44.55||||0.0019|TWO_SIDED||||||t-test, 2 sided|||||||0.0019
71902650|NCT05906732|143326935|SUPERIORITY||Mean Difference (Net)|-31.69||||0.1108|TWO_SIDED||||||t-test, 2 sided|||||||0.1108
71902651|NCT05906732|143326936|SUPERIORITY||Mean Difference (Net)|37.81||||0.184|TWO_SIDED||||||t-test, 2 sided|||||||0.1840
71902652|NCT05906732|143326937|SUPERIORITY||Mean Difference (Net)|27.33||||0.2019|TWO_SIDED||||||t-test, 2 sided|||||||0.2019
71902653|NCT05906732|143326938|SUPERIORITY|||||||0.2808|||||||t-test, 2 sided|||||||0.2808
71902654|NCT05906732|143326939|SUPERIORITY||Mean Difference (Net)|110.39||||0.1644|TWO_SIDED||||||t-test, 2 sided|||||||0.1644
71680042|NCT03796442|142877541|NON_INFERIORITY|The study was designed to have 80% power to detect 1-year AVMPG of 12.6±4.3mmHg for the study prosthesis and 11.9±4.3mmHg for the control prosthesis, with a 1-sided type I error of 2.5% and a noninferiority margin of 3mmHg. The noninferiority margin was determined by the values of 15mmHg for AVMPG of clinically significant aortic stenosis and 12mmHg for AVMPG of the control prosthesis.||||||0.0004|||||||t-test, 1 sided|||The null hypothesis was that the AvalusTM was inferior to the CEPME based on the AVMPG at 1-year echocardiographic follow-up, with a non-inferiority margin of 3mmHg. The result for the primary endpoint was presented with 97.5% one-sided confidence interval for mean difference between groups. The non-inferiority test was performed using a t-test which compared mean difference between groups with the non-inferiority margin under the one-sided significance level of 0.025.||||0.0004
71680043|NCT05129475|142877590|OTHER||Ratio of Adjusted Geometric Means|120.9|||||TWO_SIDED|90.0|109.3|133.74|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||133.74|109.30|
71680044|NCT05129475|142877591|OTHER||Ratio of Adjusted Geometric Means|119.67|||||TWO_SIDED|90.0|108.75|131.68|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||131.68|108.75|
71680045|NCT05129475|142877592|OTHER||Ratio of Adjusted Geometric Means|161.01|||||TWO_SIDED|90.0|139.05|186.44|||||Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio and 90% CI are expressed as percentages.|||186.44|139.05|
71820685|NCT04147260|143143507|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.972|TWO_SIDED|90.0|-0.34|0.35||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.35|-0.34|0.972
71820686|NCT04147260|143143507|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.02|0.6|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.60|-0.02|
71820687|NCT04147260|143143507|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.15||0.091|TWO_SIDED|90.0|-0.04|0.56||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.56|-0.04|0.091
71820688|NCT04147260|143143507|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.203||0.88|TWO_SIDED|90.0|-0.38|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.38|0.880
71820689|NCT04147260|143143508|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.043|||TWO_SIDED|90.0|-0.15|-0.01|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||-0.01|-0.15|
71820690|NCT04147260|143143508|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.037||0.757|TWO_SIDED|90.0|-0.09|0.06||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.06|-0.09|0.757
71680046|NCT00135798|142877601|SUPERIORITY_OR_OTHER|||||||0.0477||95.0||||One-sided test|Fisher Exact|||ITT analysis of pTVR: 0/13 Standard care vs. 11/46 Combined LADR-treated groups||||0.0477
71680047|NCT00135798|142877601|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 5/24 Genotypes 1,4,6 vs 6/22 Genotypes 2,3||||0.6090
71852287|NCT00936065|143218754|SUPERIORITY_OR_OTHER|||||||0.5038|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.5038
71852288|NCT00936065|143218754|SUPERIORITY_OR_OTHER|||||||0.0374|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0374
71680048|NCT00135798|142877602|SUPERIORITY_OR_OTHER|||||||0.2014||95.0||||One-sided test|Fisher Exact|||ITT analysis of CVR: 1/16 Standard care vs. 12/63 Combined LADR-treated groups||||0.2014
71680049|NCT00135798|142877602|SUPERIORITY_OR_OTHER|||||||0.9513||95.0|||||Chi-squared|||ITT analysis of LADR-treated: 6/31 Genotypes 1,4,6 vs 6/32 Genotypes 2,3||||0.9513
71680050|NCT00135798|142877603|SUPERIORITY_OR_OTHER|||||||0.0274||95.0||||One-sided test|Fisher Exact|||PP analysis of pTVR: 0/13 Standard care vs. 11/44 Combined LADR-treated groups||||0.0274
71680051|NCT00135798|142877603|SUPERIORITY_OR_OTHER|||||||0.6011||95.0|||||Chi-squared|||PP analysis of LADR-treated: 5/23 G1,4,6 vs 6/21 G2,3||||0.6011
71680052|NCT00135798|142877604|SUPERIORITY_OR_OTHER|||||||0.0153||95.0||||One-sided test|Fisher Exact|||PP analysis of CVR: 0/20 Standard care vs. 13/59 Combined LADR-treated groups||||0.0153
71820691|NCT04147260|143143508|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.049||0.158|TWO_SIDED|90.0|-0.17|0.03||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.03|-0.17|0.158
71852289|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.6061|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.6061
71852290|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.2971|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.2971
71852291|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.1119|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.1119
71852292|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.1081|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1081
71852293|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.0063|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0063
71852294|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.0055|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0055
71680053|NCT00135798|142877604|SUPERIORITY_OR_OTHER|||||||0.8065||95.0|||||Chi-squared|||PP analysis of LADR-treated: 7/30 G1,4,6 vs 6/29 G2,3||||0.8065
71680054|NCT04186806|142877605|NON_INFERIORITY|Non-inferiority margin was 1.5 cm|Mean Difference (Final Values)|-0.3426|||||TWO_SIDED|95.0|-1.2601|0.5749||The conclusion of the non-inferiority test is based on the 95% confidence interval and not on a p value. A p value was not computed.|Mixed Models Analysis||Non-inferiority testing was carried out using 95% confidence intervals.|||0.5749|-1.2601|
71680055|NCT03687372|142877706|SUPERIORITY||Mean Difference (Final Values)|3.22||||0.0003|TWO_SIDED|95.0|1.67|6.22||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||6.22|1.67|0.0003
71680056|NCT03687372|142877707|SUPERIORITY|P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|1.3|3.52|||Mixed Models Analysis|||||3.52|1.30|0.0024
71680057|NCT03687372|142877708|SUPERIORITY||Odds Ratio (OR)|14.12|||<|0.0001|TWO_SIDED|95.0|7.5|20.8|||Wilcoxon (Mann-Whitney)|||||20.8|7.5|<0.0001
71680058|NCT03687372|142877709|SUPERIORITY||Odds Ratio (OR)|3.22||||0.0009|TWO_SIDED|95.0|1.55|6.65|||Wilcoxon (Mann-Whitney)|||||6.65|1.55|0.0009
71680059|NCT03687372|142877710|SUPERIORITY||Hazard Ratio (HR)|2.56|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71680060|NCT01152359|142877716|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.05|TWO_SIDED|95.0|-0.8|2.9|||Mixed Models Analysis|||||2.9|-0.8|<0.05
71680061|NCT01152359|142877717|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.66|TWO_SIDED|95.0|-4.9|3.1|||Mixed Models Analysis|||||3.1|-4.9|0.66
71820692|NCT04147260|143143508|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|90.0|-0.12|0.22|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.22|-0.12|
71820693|NCT04147260|143143508|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.083||0.33|TWO_SIDED|90.0|-0.09|0.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.25|-0.09|0.330
71820694|NCT04147260|143143508|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.113||0.754|TWO_SIDED|90.0|-0.26|0.19||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.19|-0.26|0.754
71820695|NCT04147260|143143509|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.128|||TWO_SIDED|90.0|0.09|0.52|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.52|0.09|
71820696|NCT04147260|143143509|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.151|TWO_SIDED|90.0|-0.06|0.38||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.38|-0.06|0.151
71820697|NCT04147260|143143509|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.145||0.319|TWO_SIDED|90.0|-0.15|0.44||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.44|-0.15|0.319
71820698|NCT04147260|143143509|EQUIVALENCE|Two-sided 90% CI with an acceptance range of -0.4 to 0.4|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.136|||TWO_SIDED|90.0|-0.04|0.42|||Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values||0.42|-0.04|
71820699|NCT04147260|143143509|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.112||0.246|TWO_SIDED|90.0|-0.09|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.09|0.246
71820700|NCT04147260|143143509|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.151||0.704|TWO_SIDED|90.0|-0.25|0.36||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||0.36|-0.25|0.704
71820701|NCT04147260|143143510|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.929||0.692|TWO_SIDED|90.0|-11.92|7.99||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.99|-11.92|0.692
71820702|NCT04147260|143143510|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|4.048||0.63|TWO_SIDED|90.0|-10.14|6.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||6.21|-10.14|0.630
71852295|NCT00936065|143218755|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0031
71680062|NCT01152359|142877718|SUPERIORITY||Mean Difference (Net)|-0.8||||0.65|TWO_SIDED|95.0|-4.1|2.6|||Mixed Models Analysis|||||2.6|-4.1|0.65
71680063|NCT01056198|142877825|SUPERIORITY_OR_OTHER||||||=|0.208||95.0|||||ANCOVA|||The BWAT-m scores were compared at each of the 4 treatment weeks and at the end of the follow-up using a mixed-effects ANCOVA for the intent-to-treat population. Treatment and treatment week, as well as their interaction, were defined as fixed effects with subject as a random effect. The BWAT-m score at baseline was used as a covariate.||||=0.208
71680064|NCT01056198|142877826|SUPERIORITY_OR_OTHER||||||=|0.2737||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2737
71680065|NCT01056198|142877827|SUPERIORITY_OR_OTHER||||||=|0.2741||95.0|||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.||||=0.2741
71680066|NCT01056198|142877828|SUPERIORITY_OR_OTHER||||||=|0.0164||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.0164
71680067|NCT01056198|142877829|SUPERIORITY_OR_OTHER||||||=|0.9392||95.0|||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05||||=0.9392
71680068|NCT04464720|142877878|OTHER|||||||0.05|||||||Wilcoxon Ranked Sum|||comparing pre and post intervention PM2.5||||0.050
71820703|NCT04147260|143143510|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.482||1|TWO_SIDED|90.0|-11.07|11.07||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.07|-11.07|1.000
71820704|NCT04147260|143143510|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|4.518||0.751|TWO_SIDED|90.0|-10.55|7.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.66|-10.55|0.751
71852296|NCT00936065|143218756|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0033
71852297|NCT00936065|143218757|SUPERIORITY_OR_OTHER|||||||0.0448|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0448
71852298|NCT00936065|143218758|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.0041
71852299|NCT00936065|143218759|SUPERIORITY_OR_OTHER|||||||0.3536|TWO_SIDED||||||Log Rank|||Overall treatment difference||||0.3536
71852300|NCT00936065|143218760|SUPERIORITY_OR_OTHER|||||||0.0203|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0203
71852301|NCT00936065|143218760|SUPERIORITY_OR_OTHER|||||||0.0102|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0102
71902655|NCT05906732|143326940|SUPERIORITY||Mean Difference (Net)|-44.29||||0.0282|TWO_SIDED||||||t-test, 2 sided|||||||0.0282
71902656|NCT05906732|143326941|SUPERIORITY||Mean Difference (Net)|-37.87||||0.0306|TWO_SIDED||||||t-test, 2 sided|||||||0.0306
71680069|NCT04464720|142877881|OTHER|||||||0.043|||||||Wilcoxon Ranked Sum|||comparing pre v post intervention NO2||||0.043
71680070|NCT04464720|142877884|OTHER|||||||0.056|||||||Wilcoxon Ranked Sum|||comparing FVC pre and post intervention||||0.056
71852302|NCT00936065|143218760|SUPERIORITY_OR_OTHER|||||||0.0056|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0056
71852303|NCT00936065|143218760|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0006
71680071|NCT04464720|142877885|OTHER|||||||0.058|||||||Wilcoxon Signed Rank|||Comparing FEV1 pre and post intervention||||0.058
71680072|NCT04464720|142877887|OTHER|||||||0.058|||||||Wilcoxon Ranked Sum|||comparing FeNO pre v post intervention||||0.058
71680073|NCT02156895|142877905|OTHER||Odds Ratio (OR)|1.1||||0.1244|TWO_SIDED|95.0|0.97|1.24|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.24|0.97|0.1244
71680074|NCT02156895|142877911|OTHER||Odds Ratio (OR)|1.11||||0.0109|TWO_SIDED|95.0|1.02|1.2|||Regression, Logistic|Multiple logistic regression including total duration of treatment with Inlyta as factor||||1.2|1.02|0.0109
71852304|NCT00936065|143218760|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0066
71680075|NCT05537792|142877922|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.579|||||||t-test, 1 sided|||||||0.579
71852305|NCT00936065|143218760|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0058
71852306|NCT00936065|143218761|SUPERIORITY_OR_OTHER|||||||0.0329|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.0329
71852307|NCT00936065|143218761|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0003
71852308|NCT00936065|143218761|SUPERIORITY_OR_OTHER|||||||0.0598|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0598
71852309|NCT00936065|143218761|SUPERIORITY_OR_OTHER|||||||0.0241|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0241
71852310|NCT00936065|143218761|SUPERIORITY_OR_OTHER|||||||0.0543|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0543
71852311|NCT00936065|143218761|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.1205
71852312|NCT00936065|143218762|SUPERIORITY_OR_OTHER|||||||0.1385|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1385
71852313|NCT00936065|143218762|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0019
71852314|NCT00936065|143218762|SUPERIORITY_OR_OTHER|||||||0.0442|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0442
71852315|NCT00936065|143218762|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0034
71852316|NCT00936065|143218762|SUPERIORITY_OR_OTHER|||||||0.0454|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0454
71852317|NCT00936065|143218762|SUPERIORITY_OR_OTHER|||||||0.0539|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0539
71852318|NCT00936065|143218763|SUPERIORITY_OR_OTHER|||||||0.1723|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1723
71902657|NCT05906732|143326942|SUPERIORITY||Mean Difference (Net)|-53.42||||0.0016|TWO_SIDED||||||t-test, 2 sided|||||||0.0016
71680076|NCT05537792|142877922|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.0008|||||||t-test, 1 sided|||||||0.0008
71680077|NCT05537792|142877922|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.5513|||||||t-test, 1 sided|||||||0.5513
71680078|NCT05537792|142877922|OTHER|Paired t-tests were used to compare the offline forward estimation error of each adapted forward estimator with the baseline during overground walking.||||||0.00034|||||||t-test, 1 sided|||||||0.00034
71680079|NCT03495154|142877930|OTHER|This was not a comparative endpoint.|Percentage and confidence interval|3.3|||||TWO_SIDED|95.0|1.0|8.5||||||Number of participants with hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair||8.5|1.0|
71680080|NCT03495154|142877931|OTHER|Statistical Analysis is based on number of participants with incidence of with ADEs at discharge. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|14.0|||||TWO_SIDED|||||||||||||
71820705|NCT04147260|143143510|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|1.68|STANDARD_ERROR_OF_MEAN|3.894||0.669|TWO_SIDED|90.0|-6.17|9.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.52|-6.17|0.669
71680081|NCT03495154|142877931|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 1 month. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|31.0|||||TWO_SIDED|||||||||||||
71820706|NCT04147260|143143510|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|5.123||0.546|TWO_SIDED|90.0|-13.44|7.21||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||7.21|-13.44|0.546
71820707|NCT04147260|143143511|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-12.45|STANDARD_ERROR_OF_MEAN|11.385||0.281|TWO_SIDED|90.0|-35.44|10.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.54|-35.44|0.281
71820708|NCT04147260|143143511|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-16.14|STANDARD_ERROR_OF_MEAN|9.35||0.092|TWO_SIDED|90.0|-35.02|2.74||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.74|-35.02|0.092
71820709|NCT04147260|143143511|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|12.662||0.772|TWO_SIDED|90.0|-21.88|29.27||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||29.27|-21.88|0.772
71820710|NCT04147260|143143511|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|13.255||0.539|TWO_SIDED|90.0|-34.93|18.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.50|-34.93|0.539
71820711|NCT04147260|143143511|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-4.71|STANDARD_ERROR_OF_MEAN|11.424||0.682|TWO_SIDED|90.0|-27.74|18.31||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||18.31|-27.74|0.682
71820712|NCT04147260|143143511|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|15.03||0.817|TWO_SIDED|90.0|-33.79|26.79||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||26.79|-33.79|0.817
71820713|NCT04147260|143143512|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|5.327||0.891|TWO_SIDED|90.0|-11.49|10.02||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||10.02|-11.49|0.891
71852319|NCT00936065|143218763|SUPERIORITY_OR_OTHER|||||||0.0292|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0292
71852320|NCT00936065|143218763|SUPERIORITY_OR_OTHER|||||||0.0908|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0908
71902658|NCT05906732|143326943|SUPERIORITY||Mean Difference (Net)|-44.25||||0.1378|TWO_SIDED||||||t-test, 2 sided|||||||0.1378
71680082|NCT03495154|142877931|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 3 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|34.0|||||TWO_SIDED|||||||||||||
71680083|NCT03495154|142877931|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 12 months. Adverse Device Effects (ADE) is inclusive of both procedure and/or device related AEs.|Number of Subjects with ADEs|40.0|||||TWO_SIDED|||||||||||||
71852321|NCT00936065|143218763|SUPERIORITY_OR_OTHER|||||||0.5678|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.5678
71852322|NCT00936065|143218763|SUPERIORITY_OR_OTHER|||||||0.482|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.4820
71852323|NCT00936065|143218763|SUPERIORITY_OR_OTHER|||||||0.0394|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0394
71852324|NCT00936065|143218764|SUPERIORITY_OR_OTHER|||||||0.1079|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1079
71852325|NCT00936065|143218764|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0004
71852326|NCT00936065|143218764|SUPERIORITY_OR_OTHER|||||||0.0146|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.0146
71902659|NCT03207022|143326951|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71820714|NCT04147260|143143512|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|4.375||0.417|TWO_SIDED|90.0|-12.42|5.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.25|-12.42|0.417
71820715|NCT04147260|143143512|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.85|STANDARD_ERROR_OF_MEAN|5.925||0.633|TWO_SIDED|90.0|-9.11|14.82||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.82|-9.11|0.633
71852327|NCT00936065|143218764|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0019
71820716|NCT04147260|143143512|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|6.79|STANDARD_ERROR_OF_MEAN|4.384||0.129|TWO_SIDED|90.0|-2.05|15.62||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||15.62|-2.05|0.129
71852328|NCT00936065|143218764|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0062
71852329|NCT00936065|143218764|SUPERIORITY_OR_OTHER|||||||0.0197|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0197
71852330|NCT00936065|143218765|SUPERIORITY_OR_OTHER|||||||0.1229|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 2||||0.1229
71852331|NCT00936065|143218765|SUPERIORITY_OR_OTHER|||||||0.0136|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 4||||0.0136
71852332|NCT00936065|143218765|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 8||||0.1578
71852333|NCT00936065|143218765|SUPERIORITY_OR_OTHER|||||||0.0565|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 12||||0.0565
71852334|NCT00936065|143218765|SUPERIORITY_OR_OTHER|||||||0.0685|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 18||||0.0685
71852335|NCT00936065|143218765|SUPERIORITY_OR_OTHER|||||||0.0493|TWO_SIDED||||||ANCOVA|||Overall treatment difference at Week 24||||0.0493
71852336|NCT00936065|143218766|SUPERIORITY_OR_OTHER|||||||0.3112|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3112
71852337|NCT00936065|143218766|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0196
71852338|NCT00936065|143218766|SUPERIORITY_OR_OTHER|||||||0.0109|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0109
71852339|NCT00936065|143218766|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0035
71852340|NCT00936065|143218766|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0603
71852341|NCT00936065|143218766|SUPERIORITY_OR_OTHER|||||||0.2184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2184
71852342|NCT00936065|143218767|SUPERIORITY_OR_OTHER|||||||0.1774|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1774
71852343|NCT00936065|143218767|SUPERIORITY_OR_OTHER|||||||0.1195|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1195
71852344|NCT00936065|143218767|SUPERIORITY_OR_OTHER|||||||0.0606|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0606
71852345|NCT00936065|143218767|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0030
71852346|NCT00936065|143218767|SUPERIORITY_OR_OTHER|||||||0.1567|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1567
71852347|NCT00936065|143218767|SUPERIORITY_OR_OTHER|||||||0.2094|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.2094
71852348|NCT00936065|143218768|SUPERIORITY_OR_OTHER|||||||0.0302|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0302
71852349|NCT00936065|143218768|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0980
71852350|NCT00936065|143218768|SUPERIORITY_OR_OTHER|||||||0.0711|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0711
71852351|NCT00936065|143218768|SUPERIORITY_OR_OTHER|||||||0.0077|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0077
71852352|NCT00936065|143218768|SUPERIORITY_OR_OTHER|||||||0.1553|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1553
71852353|NCT00936065|143218768|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
71852354|NCT00936065|143218769|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0060
71852355|NCT00936065|143218769|SUPERIORITY_OR_OTHER|||||||0.0058|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0058
71852356|NCT00936065|143218769|SUPERIORITY_OR_OTHER|||||||0.0127|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0127
71852357|NCT00936065|143218769|SUPERIORITY_OR_OTHER|||||||0.0068|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0068
71852358|NCT00936065|143218769|SUPERIORITY_OR_OTHER|||||||0.0096|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0096
71852359|NCT00936065|143218769|SUPERIORITY_OR_OTHER|||||||0.0132|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0132
71852360|NCT00936065|143218770|SUPERIORITY_OR_OTHER|||||||0.6904|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.6904
71852361|NCT00936065|143218770|SUPERIORITY_OR_OTHER|||||||0.7021|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.7021
71852362|NCT00936065|143218770|SUPERIORITY_OR_OTHER|||||||0.2199|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2199
71852363|NCT00936065|143218770|SUPERIORITY_OR_OTHER|||||||0.5071|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5071
71852364|NCT00936065|143218770|SUPERIORITY_OR_OTHER|||||||0.4765|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4765
71852365|NCT00936065|143218770|SUPERIORITY_OR_OTHER|||||||0.8662|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.8662
71852366|NCT00936065|143218771|SUPERIORITY_OR_OTHER|||||||0.1144|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.1144
71852367|NCT00936065|143218771|SUPERIORITY_OR_OTHER|||||||0.4509|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4509
71902660|NCT03207022|143326952|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71902661|NCT03207022|143326953|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71902662|NCT03656926|143326957|SUPERIORITY|Estimates are from a Linear Mixed Model on the response variable change from baseline in FEV1 with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region (North America vs all other countries together), age (\<55 versus \>=55 years), use of azithromycin at randomization, and time as random effect.|least square mean difference|-0.028||||0.6639|TWO_SIDED|95.0|-0.16|0.104||This is a 1-side p value.|Mixed Models Analysis|||V9 - week 48||0.104|-0.160|0.6639
71902663|NCT01798706|143326986|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.81|-0.464||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline HbA1c value as a covariate.||-0.464|-0.81|< 0.0001
71902664|NCT01798706|143326987|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.05|STANDARD_ERROR_OF_MEAN|0.464|<|0.0001|TWO_SIDED|95.0|-5.96|-4.132||Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.||-4.132|-5.96|< 0.0001
71902665|NCT01798706|143326988|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.219|<|0.0001|TWO_SIDED|95.0|-1.39|-0.527||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.||-0.527|-1.39|< 0.0001
71902666|NCT01798706|143326989|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.278|<|0.0001|TWO_SIDED|95.0|-1.862|-0.769||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline body weight value as a covariate.||-0.769|-1.862|< 0.0001
71902667|NCT01798706|143326990|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.262||0.2347|TWO_SIDED|95.0|-0.828|0.204||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to \<60, ≥60 ml/min/1.73 m\^2), and country as fixed effects and baseline FPG value as a covariate.||0.204|-0.828|0.2347
71902668|NCT03238235|143327003|SUPERIORITY||Log Difference of the least square means|0.04||||0.8282|TWO_SIDED|95.0|-0.3|0.38||ANCOVA model was performed considering the difference between log of total fibrosis and log baseline values as dependent variable; log baseline value was included as covariate, treatment and concomitant steroid use as independent class variables.|ANCOVA|||total fibrosis at visit 11||0.38|-0.30|0.8282
71902669|NCT03238235|143327003|SUPERIORITY|Mixed model was performed considering the difference between log Visit 11 and log baseline values as dependent variable; log baseline as covariate, treatment was included as independent class variable and treatment by sequence interaction. The sequence of biopsy site (R-L, L-R) was included as a fixed effect and subject as a random effect. If the treatment by sequence interaction was p\>0.10, then the model without the interaction term is presented.|Log Difference of Least Square Means|-0.11||||0.6465|TWO_SIDED|95.0|-0.59|0.37|||Mixed Models Analysis|||A Mixed Model was fitted to the data in order to evaluate the difference in total fibrosis between biopsy sites||0.37|-0.59|0.6465
71902670|NCT03238235|143327004|SUPERIORITY||Log Difference of Least Square Means|-0.05||||0.1991|TWO_SIDED|95.0|-0.12|0.03||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Vastus lateralis||0.03|-0.12|0.1991
71902671|NCT03238235|143327004|SUPERIORITY||difference of the least square means|-0.27||||0.7849|TWO_SIDED|95.0|-2.22|1.69||ANCOVA model was performed considering baseline fat fraction of vastus lateralis or fat fraction in the soleus value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Soleus||1.69|-2.22|0.7849
71902672|NCT03238235|143327005|SUPERIORITY||Difference of Least Square Means|-1.35||||0.0149|TWO_SIDED|95.0|-2.43|-0.28||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole thigh at visit 11||-0.28|-2.43|0.0149
71902673|NCT03238235|143327005|SUPERIORITY||Difference of Least Square Means|-1.96||||0.0022|TWO_SIDED|95.0|-3.18|-0.75||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at visit 11||-0.75|-3.18|0.0022
71902674|NCT03238235|143327005|SUPERIORITY||Difference of least square means|-0.58||||0.4869|TWO_SIDED|95.0|-2.24|1.08||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at visit 11||1.08|-2.24|0.4869
71852368|NCT00936065|143218771|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4350
71852369|NCT00936065|143218771|SUPERIORITY_OR_OTHER|||||||0.6085|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6085
71852370|NCT00936065|143218771|SUPERIORITY_OR_OTHER|||||||0.2582|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2582
71852371|NCT00936065|143218771|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.5490
71852372|NCT00936065|143218772|SUPERIORITY_OR_OTHER|||||||0.3287|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3287
71852373|NCT00936065|143218772|SUPERIORITY_OR_OTHER|||||||0.4149|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4149
71852374|NCT00936065|143218772|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.3837
71852375|NCT00936065|143218772|SUPERIORITY_OR_OTHER|||||||0.6777|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.6777
71852376|NCT00936065|143218772|SUPERIORITY_OR_OTHER|||||||0.4976|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.4976
71852377|NCT00936065|143218772|SUPERIORITY_OR_OTHER|||||||0.4189|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.4189
71852378|NCT00936065|143218773|SUPERIORITY_OR_OTHER|||||||0.476|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4760
71852379|NCT00936065|143218773|SUPERIORITY_OR_OTHER|||||||0.404|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.4040
71852380|NCT00936065|143218773|SUPERIORITY_OR_OTHER|||||||0.4753|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4753
71852381|NCT00936065|143218773|SUPERIORITY_OR_OTHER|||||||0.5084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.5084
71852382|NCT00936065|143218773|SUPERIORITY_OR_OTHER|||||||0.2293|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2293
71852383|NCT00936065|143218773|SUPERIORITY_OR_OTHER|||||||0.3822|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3822
71852384|NCT00936065|143218774|SUPERIORITY_OR_OTHER|||||||0.2691|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.2691
71852385|NCT00936065|143218774|SUPERIORITY_OR_OTHER|||||||0.0142|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0142
71852386|NCT00936065|143218774|SUPERIORITY_OR_OTHER|||||||0.0383|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0383
71852387|NCT00936065|143218774|SUPERIORITY_OR_OTHER|||||||0.0026|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0026
71852388|NCT00936065|143218774|SUPERIORITY_OR_OTHER|||||||0.0475|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0475
71852389|NCT00936065|143218774|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0205
71852390|NCT00936065|143218775|SUPERIORITY_OR_OTHER|||||||0.0512|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0512
71852391|NCT00936065|143218775|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0024
71852392|NCT00936065|143218775|SUPERIORITY_OR_OTHER|||||||0.0946|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0946
71852393|NCT00936065|143218775|SUPERIORITY_OR_OTHER|||||||0.0935|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0935
71852394|NCT00936065|143218775|SUPERIORITY_OR_OTHER|||||||0.2073|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2073
71852395|NCT00936065|143218775|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
71852396|NCT00936065|143218776|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0202
71852397|NCT00936065|143218776|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0090
71852398|NCT00936065|143218776|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0742
71852399|NCT00936065|143218776|SUPERIORITY_OR_OTHER|||||||0.0445|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0445
71852400|NCT00936065|143218776|SUPERIORITY_OR_OTHER|||||||0.2211|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.2211
71852401|NCT00936065|143218776|SUPERIORITY_OR_OTHER|||||||0.1982|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.1982
71852402|NCT00936065|143218777|SUPERIORITY_OR_OTHER|||||||0.0409|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0409
71852403|NCT00936065|143218777|SUPERIORITY_OR_OTHER|||||||0.145|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1450
71852404|NCT00936065|143218777|SUPERIORITY_OR_OTHER|||||||0.201|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.2010
71852405|NCT00936065|143218777|SUPERIORITY_OR_OTHER|||||||0.0424|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0424
71852406|NCT00936065|143218777|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0090
71852407|NCT00936065|143218777|SUPERIORITY_OR_OTHER|||||||0.0116|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0116
71852408|NCT00936065|143218778|SUPERIORITY_OR_OTHER|||||||0.3355|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3355
71852409|NCT00936065|143218778|SUPERIORITY_OR_OTHER|||||||0.0341|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0341
71852410|NCT00936065|143218778|SUPERIORITY_OR_OTHER|||||||0.0899|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0899
71852411|NCT00936065|143218778|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0062
71852412|NCT00936065|143218778|SUPERIORITY_OR_OTHER|||||||0.1241|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1241
71852413|NCT00936065|143218778|SUPERIORITY_OR_OTHER|||||||0.0393|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0393
71852414|NCT00936065|143218779|SUPERIORITY_OR_OTHER|||||||0.3402|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.3402
71680084|NCT03495154|142877931|OTHER|Statistical Analysis is based on number of participants with incidence of ADEs within 24 months. Adverse Device Effects (ADEs) are inclusive of both procedure and device related AEs.|Number of Subjects with ADEs|42.0|||||TWO_SIDED|||||||||||||
71820717|NCT04147260|143143512|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.29|STANDARD_ERROR_OF_MEAN|3.778||0.548|TWO_SIDED|90.0|-5.33|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-5.33|0.548
71680085|NCT03495154|142877932|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 1M|0.0|||||TWO_SIDED|95.0|0.0|2.9||||||||2.9|0|
71820718|NCT04147260|143143512|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|4.5|STANDARD_ERROR_OF_MEAN|4.97||0.37|TWO_SIDED|90.0|-5.51|14.52||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.52|-5.51|0.370
71852415|NCT00936065|143218779|SUPERIORITY_OR_OTHER|||||||0.1184|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1184
71852416|NCT00936065|143218779|SUPERIORITY_OR_OTHER|||||||0.0104|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0104
71852417|NCT00936065|143218779|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0010
71852418|NCT00936065|143218779|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.0250
71852419|NCT00936065|143218779|SUPERIORITY_OR_OTHER|||||||0.041|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.0410
71852420|NCT00936065|143218780|SUPERIORITY_OR_OTHER|||||||0.0894|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.0894
71852421|NCT00936065|143218780|SUPERIORITY_OR_OTHER|||||||0.0084|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.0084
71852422|NCT00936065|143218780|SUPERIORITY_OR_OTHER|||||||0.0727|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.0727
71852423|NCT00936065|143218780|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.0337
71852424|NCT00936065|143218780|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1380
71852425|NCT00936065|143218780|SUPERIORITY_OR_OTHER|||||||0.3415|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.3415
71852426|NCT00936065|143218781|SUPERIORITY_OR_OTHER|||||||0.4407|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 2||||0.4407
71852427|NCT00936065|143218781|SUPERIORITY_OR_OTHER|||||||0.1768|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 4||||0.1768
71852428|NCT00936065|143218781|SUPERIORITY_OR_OTHER|||||||0.4636|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 8||||0.4636
71852429|NCT00936065|143218781|SUPERIORITY_OR_OTHER|||||||0.334|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 12||||0.3340
71852430|NCT00936065|143218781|SUPERIORITY_OR_OTHER|||||||0.1785|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 18||||0.1785
71852431|NCT00936065|143218781|SUPERIORITY_OR_OTHER|||||||0.7428|TWO_SIDED||||||Kruskal-Wallis|||Overall treatment difference at Week 24||||0.7428
71820719|NCT04147260|143143513|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|10.379||0.375|TWO_SIDED|90.0|-30.26|11.66||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||11.66|-30.26|0.375
71820720|NCT04147260|143143513|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.49|STANDARD_ERROR_OF_MEAN|8.524||0.185|TWO_SIDED|90.0|-28.7|5.73||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.73|-28.70|0.185
71820721|NCT04147260|143143513|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|11.544||0.851|TWO_SIDED|90.0|-21.12|25.5||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||25.50|-21.12|0.851
71820722|NCT04147260|143143513|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-26.64|STANDARD_ERROR_OF_MEAN|9.405||0.007|TWO_SIDED|90.0|-45.59|-7.69||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-7.69|-45.59|0.007
71820723|NCT04147260|143143513|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-15.01|STANDARD_ERROR_OF_MEAN|8.106||0.071|TWO_SIDED|90.0|-31.34|1.33||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||1.33|-31.34|0.071
71820724|NCT04147260|143143513|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-11.63|STANDARD_ERROR_OF_MEAN|10.664||0.281|TWO_SIDED|90.0|-33.13|9.86||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.86|-33.13|0.281
71820725|NCT04147260|143143514|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|5.37||0.599|TWO_SIDED|90.0|-13.69|8.0||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.00|-13.69|0.599
71820726|NCT04147260|143143514|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|4.41||0.824|TWO_SIDED|90.0|-7.92|9.9||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||9.90|-7.92|0.824
71820727|NCT04147260|143143514|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-3.83|STANDARD_ERROR_OF_MEAN|5.973||0.525|TWO_SIDED|90.0|-15.9|8.23||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||8.23|-15.90|0.525
71820728|NCT04147260|143143514|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|6.867||0.25|TWO_SIDED|90.0|-21.84|5.84||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||5.84|-21.84|0.250
71820729|NCT04147260|143143514|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|5.19|STANDARD_ERROR_OF_MEAN|5.919||0.386|TWO_SIDED|90.0|-6.74|17.12||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||17.12|-6.74|0.386
71820730|NCT04147260|143143514|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-13.19|STANDARD_ERROR_OF_MEAN|7.787||0.097|TWO_SIDED|90.0|-28.88|2.51||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||2.51|-28.88|0.097
71820731|NCT04147260|143143515|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|0.99|STANDARD_ERROR_OF_MEAN|6.842||0.885|TWO_SIDED|90.0|-12.83|14.81||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||14.81|-12.83|0.885
71820732|NCT04147260|143143515|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|28.9|STANDARD_ERROR_OF_MEAN|5.619|<|0.001|TWO_SIDED|90.0|17.55|40.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||40.25|17.55|<0.001
71820733|NCT04147260|143143515|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-27.91|STANDARD_ERROR_OF_MEAN|7.61|<|0.001|TWO_SIDED|90.0|-43.28|-12.54||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-12.54|-43.28|<0.001
71820734|NCT04147260|143143515|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-20.13|STANDARD_ERROR_OF_MEAN|8.041||0.016|TWO_SIDED|90.0|-36.33|-3.92||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-3.92|-36.33|0.016
71852432|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.5377|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.5377
71852433|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.1419|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.1419
71902675|NCT03238235|143327005|SUPERIORITY||Difference of Least Square Means|-1.59||||0.0939|TWO_SIDED|95.0|-3.47|0.29||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||0.29|-3.47|0.0939
71902676|NCT03238235|143327005|SUPERIORITY||Difference of Least Square Means|-0.89||||0.1579|TWO_SIDED|95.0|-2.13|0.36||ANCOVA model was performed considering baseline Fat Fraction of lower limb muscles value as covariate and treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis girdle at visit 11||0.36|-2.13|0.1579
71680086|NCT03495154|142877932|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 3M|0.0|||||TWO_SIDED|95.0|0.0|3.0||||||||3.0|0|
71902677|NCT03238235|143327006|SUPERIORITY||Difference of Least Square Means|0.4||||0.777|TWO_SIDED|95.0|-2.45|3.26||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at visit 11||3.26|-2.45|0.7770
71902678|NCT03238235|143327006|SUPERIORITY||Difference of Least Square Means|-0.09||||0.8926|TWO_SIDED|95.0|-1.35|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Quadriceps at Visit 11||1.18|-1.35|0.8926
71902679|NCT03238235|143327006|SUPERIORITY||Difference of Least Square Means|0.35||||0.572|TWO_SIDED|95.0|-0.88|1.58||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Medial Thigh at Visit 11||1.58|-0.88|0.5720
71902680|NCT03238235|143327006|SUPERIORITY||Difference of Least Square Means|0.11||||0.8386|TWO_SIDED|95.0|-0.97|1.18||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Hamstrings at Visit 11||1.18|-0.97|0.8386
71902681|NCT03238235|143327006|SUPERIORITY||Difference of Least Square Means|-0.22||||0.8591|TWO_SIDED|95.0|-2.68|2.25||ANCOVA model was performed considering baseline CSA as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Triceps Surae at Visit 11||2.25|-2.68|0.8591
71680087|NCT03495154|142877932|OTHER|This was not a comparative endpoint.|% of Subjects with Recurrence within 24M|4.0|||||TWO_SIDED|95.0|1.2|9.6||||||||9.6|1.2|
71902682|NCT03238235|143327006|SUPERIORITY||Difference of Least Square Means|0.32||||0.7392|TWO_SIDED|95.0|-1.6|2.24|||ANCOVA|||Pelvis Girdle at Visit 11||2.24|-1.60|0.7392
71680088|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.75|1.17|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 3||1.17|0.75|<0.001
71902683|NCT03238235|143327007|SUPERIORITY||Difference of Least Square Means|1.37||||0.0375|TWO_SIDED|95.0|0.08|2.65||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Whole Thigh at Visit 11||2.65|0.08|0.0375
71902684|NCT03238235|143327007|SUPERIORITY||difference of least square means|0.63||||0.0528|TWO_SIDED|95.0|-0.01|1.27||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Quadriceps at Visit 11||1.27|-0.01|0.0528
71902685|NCT03238235|143327007|SUPERIORITY||Difference of Least Square Means|0.36||||0.2012|TWO_SIDED|95.0|-0.2|0.91||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Medial Thigh at Visit 11||0.91|-0.20|0.2012
71902686|NCT03238235|143327007|SUPERIORITY||Difference of Least Square Means|0.75||||0.4676|TWO_SIDED|95.0|-1.33|2.83||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Triceps Surae at Visit 11||2.83|-1.33|0.4676
71902687|NCT03238235|143327007|SUPERIORITY||Difference of Least Square Means|0.54||||0.1549|TWO_SIDED|95.0|-0.21|1.3||ANCOVA model was performed considering baseline Contractile Area value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Pelvis Girdle at Visit 11||1.30|-0.21|0.1549
71902688|NCT03238235|143327008|SUPERIORITY||Difference of Least Square Means|-619.2||||0.324|TWO_SIDED|95.0|-1872.37|633.98||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||CSA Type II at Visit 11||633.98|-1872.37|0.3240
71680089|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.88|1.33|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 7F||1.33|0.88|<0.001
71902689|NCT03238235|143327008|SUPERIORITY||Difference of Least Square Means|-572.54||||0.307|TWO_SIDED|95.0|-1690.73|545.64||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total CSA at Visit 11||545.64|-1690.73|0.3070
71902690|NCT03238235|143327009|SUPERIORITY||Log Difference of Least Square Means|-0.27||||0.1055|TWO_SIDED|95.0|-0.59|0.06||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Fibers with nuclear centralizations (%) at Visit 11||0.06|-0.59|0.1055
71820735|NCT04147260|143143515|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|18.5|STANDARD_ERROR_OF_MEAN|6.931||0.011|TWO_SIDED|90.0|4.53|32.46||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||32.46|4.53|0.011
71820736|NCT04147260|143143515|OTHER|Mixed model for repeated measures (MMRM) with unstructured (UN) covariance matrix on photosensitivity index (PI) values|Mean Difference (Final Values)|-38.62|STANDARD_ERROR_OF_MEAN|9.118|<|0.001|TWO_SIDED|90.0|-57.0|-20.25||P-value is for testing Least Squares Mean Difference=0|Linear mixed model|Treatment, time, and treatment-time interaction as fixed effects and subject as a random effect||||-20.25|-57.00|<0.001
71820737|NCT05126459|143143558|SUPERIORITY|||||||0.016||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events during sedation.||||0.016
71852434|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.5391|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.5391
71852435|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.2589|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.2589
71852436|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.0635|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0635
71852437|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.1172|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.1172
71852438|NCT00936065|143218782|SUPERIORITY_OR_OTHER|||||||0.1247|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.1247
71852439|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.9429|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Baseline||||0.9429
71852440|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.0927|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 2||||0.0927
71852441|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.0151|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 4||||0.0151
71852442|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.1124|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 8||||0.1124
71852443|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.0242|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 12||||0.0242
71852444|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.0237|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 18||||0.0237
71852445|NCT00936065|143218783|SUPERIORITY_OR_OTHER|||||||0.0176|TWO_SIDED||||||Fisher Exact|||Overall treatment difference at Week 24||||0.0176
71852446|NCT02389894|143218784|SUPERIORITY||Risk Difference (RD)|6.9||||0.22|TWO_SIDED|95.0|-4.2|17.9|||Chi-squared|The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||17.9|-4.2|0.22
71852447|NCT02389894|143218784|SUPERIORITY||Risk Difference (RD)|1.3||||0.84|TWO_SIDED|95.0|-11.2|13.8||The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|Chi-squared||The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.||13.8|-11.2|0.84
71852448|NCT02389894|143218785|SUPERIORITY||Risk Difference (RD)|9.7||||0.08|TWO_SIDED|95.0|-1.2|20.5|||Chi-squared||The absolute difference was computed as Embol-x minus control|||20.5|-1.2|0.08
71852449|NCT02389894|143218785|SUPERIORITY||Risk Difference (RD)|-2.8||||0.61|TWO_SIDED|95.0|-13.5|7.9|||Chi-squared||The absolute difference was computed as Cardiogard minus control|||7.9|-13.5|0.61
71852450|NCT00145496|143218805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7177||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in NSA Scale total score between asenapine and olanzapine at Day 182.||||0.7177
71852451|NCT00145496|143218806|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0565||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in QLS total score between asenapine and olanzapine at Day 182.||||0.0565
71852452|NCT00145496|143218807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in body weight between asenapine and olanzapine at Day 182.||||<0.0001
71852453|NCT01052714|143218808|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71852454|NCT01052714|143218809|SUPERIORITY|||||||0.718|||||||Mixed Models Analysis|||||||0.718
71852455|NCT01052714|143218810|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71820738|NCT05126459|143143559|SUPERIORITY|||||||0.211||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in Musculo skeletal related sedation related events at 8 hours after sedation.||||0.211
71852456|NCT01052714|143218811|SUPERIORITY|||||||0.676|||||||Mixed Models Analysis|||||||0.676
71852457|NCT01052714|143218812|SUPERIORITY|||||||0.141|||||||Mixed Models Analysis|||||||0.141
71852458|NCT01052714|143218813|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
71852459|NCT01052714|143218814|SUPERIORITY|||||||0.322|||||||Mixed Models Analysis|||||||0.322
71680090|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.12|||<|0.001|TWO_SIDED|95.0|0.93|1.36|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 8||1.36|0.93|<0.001
71680091|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.86|1.29|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 9N||1.29|0.86|<0.001
71820739|NCT05126459|143143560|SUPERIORITY|||||||0.374||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.374
71820740|NCT05126459|143143561|SUPERIORITY|||||||0.55|||||||ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens.||||0.55
71820741|NCT05126459|143143562|SUPERIORITY|||||||0.16||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens 8 hours after sedation.||||0.16
71820742|NCT05126459|143143563|SUPERIORITY|||||||0.012||||||The threshold for statistical significance was p=0.05.|ANOVA|||Null hypothesis: there is no significant difference in GI reaction between the 3 regimens at 24 hours after sedation.||||0.012
71820743|NCT02204293|143143564|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.||||||0.1811|||||||Fisher Exact|||||||0.1811
71820744|NCT02204293|143143579|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|19.9||||0.3175|TWO_SIDED|95.0|-15.0|51.3|||Fisher Exact|||||51.3|-15.0|0.3175
71820745|NCT02204293|143143580|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|31.7||||0.0922|TWO_SIDED|95.0|-2.9|61.8|||Fisher Exact|||||61.8|-2.9|0.0922
71820746|NCT02204293|143143581|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.0||||0.0858|TWO_SIDED|95.0|-1.5|61.1|||Fisher Exact|||||61.1|-1.5|0.0858
71852460|NCT01052714|143218815|SUPERIORITY|||||||0.652|||||||Mixed Models Analysis|||||||0.652
71852461|NCT01052714|143218816|SUPERIORITY|||||||0.663|||||||Mixed Models Analysis|||||||0.663
71852462|NCT01052714|143218817|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.9
71852463|NCT01052714|143218818|SUPERIORITY|||||||0.415|||||||Mixed Models Analysis|||||||0.415
71852464|NCT01052714|143218819|SUPERIORITY|||||||0.687|||||||Mixed Models Analysis|||||||0.687
71852465|NCT01052714|143218820|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.22
71852466|NCT01052714|143218821|SUPERIORITY|||||||0.059|||||||Mixed Models Analysis|||||||0.059
71852467|NCT01052714|143218822|SUPERIORITY|||||||0.79|||||||Mixed Models Analysis|||||||0.79
71852468|NCT01052714|143218823|SUPERIORITY|||||||0.146|||||||Mixed Models Analysis|||||||0.146
71852469|NCT01052714|143218824|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71852470|NCT01052714|143218825|SUPERIORITY|||||||0.763|||||||Mixed Models Analysis|||||||0.763
71852471|NCT02168153|143218826|SUPERIORITY||Mean Difference (Final Values)|-3.49||||0.76|TWO_SIDED|95.0|-25.75|18.77|||ANCOVA|adjusted for age||Between group differences||18.77|-25.75|0.76
71852472|NCT02168153|143218827|SUPERIORITY||Mean Difference (Final Values)|0.97||||0.92|TWO_SIDED|95.0|-18.04|19.98|||ANCOVA|adjusted for age||Between group differences||19.98|-18.04|0.92
71852473|NCT02168153|143218828|SUPERIORITY||Mean Difference (Final Values)|3.49||||0.7|TWO_SIDED|95.0|-14.4|21.39|||ANCOVA|adjusted for age||Between group differences||21.39|-14.4|0.70
71852474|NCT02168153|143218829|SUPERIORITY||Mean Difference (Final Values)|0.988||||0.15|TWO_SIDED|95.0|-0.373|2.349|||ANCOVA|adjusted for age||Between group differences||2.349|-0.373|0.15
71852475|NCT02168153|143218830|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.32|TWO_SIDED|95.0|-1.24|0.41|||ANCOVA|adjusted for age||Between group differences||0.41|-1.24|0.32
71852476|NCT01636778|143218856|SUPERIORITY_OR_OTHER||Percentage|88.0|||||TWO_SIDED|95.0|74.0|96.0||||||||96|74|
71852477|NCT01154699|143218917|SUPERIORITY_OR_OTHER|||||||0.8|||||||t-test, 2 sided|||The difference in the change in asthma control during the Usual care and the Bilevel PAP period were compared.||||0.8
71852478|NCT01154699|143218918|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||Change in PC20 between the two arms||||0.20
71852479|NCT01154699|143218919|SUPERIORITY_OR_OTHER|||||||0.78|||||||t-test, 2 sided|||||||0.78
71852480|NCT01154699|143218920|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||||||0.61
71852481|NCT01154699|143218921|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
71852482|NCT01154699|143218922|SUPERIORITY_OR_OTHER|||||||0.76|||||||t-test, 2 sided|||||||0.76
71852483|NCT03530345|143218928|SUPERIORITY||Mean Difference (Net)|-1.07|STANDARD_ERROR_OF_MEAN|0.404||0.0111|TWO_SIDED|95.0|-1.89|-0.26||2-sided p-value for testing superiority of neridronic acid 400 mg compared to placebo.|Mixed Models Analysis|The degrees of freedom of the denominator are estimated using the Kenward-Roger approximation.|The primary endpoint estimate was the least squares mean differences of change from baseline in pain NRS (electronic diary) at Week 12 between neridronate and Placebo.|Mixed-effects model for repeated measures (MMRM) defined with baseline pain intensity as covariate, the factors geographic region, week, treatment and treatment-by-week as fixed effects, and an unstructured covariance matrix to model the covariance structure of the repeated measurements.||-0.26|-1.89|0.0111
71852484|NCT01184755|143218944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.561256|STANDARD_ERROR_OF_MEAN|0.216403||0.01|TWO_SIDED|95.0|-0.987999|-0.134513||This is an intention-to-treat analysis|Mixed effects regression analysis|||This is the change in Systolic BP at 8 weeks||-.134513|-.987999|.01
71820747|NCT02204293|143143582|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|32.4||||0.075|TWO_SIDED|95.0|-0.7|60.5|||Fisher Exact|||||60.5|-0.7|0.075
71820748|NCT02204293|143143583|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||||43.4|-12.6|0.4018
71820749|NCT02204293|143143584|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|5.2||||1|TWO_SIDED|95.0|-18.8|29.2|||Fisher Exact|||||29.2|-18.8|1
71820750|NCT02204293|143143585|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|24.8||||0.1642|TWO_SIDED|95.0|-8.0|54.2|||Fisher Exact|||EULAR DAS28-ESR Response||54.2|-8.0|0.1642
71820751|NCT02204293|143143585|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|25.2||||0.1756|TWO_SIDED|95.0|-9.1|55.1|||Fisher Exact|||EULAR DAS28-CRP Response||55.1|-9.1|0.1756
71820752|NCT02204293|143143586|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|3.9||||1|TWO_SIDED|95.0|-27.7|35.0|||Fisher Exact|||DAS28 (ESR) LDA||35.0|-27.7|1
71852485|NCT01184755|143218944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.391195|STANDARD_ERROR_OF_MEAN|0.140034||0.006|TWO_SIDED|95.0|-0.667312|-0.115079|||mixed effects regression analysis|||This is the analysis of change in diastolic BP from Ambulatory BP monitoring.||-.115079|-.667312|.006
71852486|NCT00318591|143218945|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.|Hazard Ratio (HR)|1.502||||0.0383|TWO_SIDED|95.0|1.022|2.207||p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.|Kaplan-Meier|||The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.||2.207|1.022|0.0383
71852487|NCT00318591|143218947|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA analysis. Limit of significant difference \<0.05||||||0.767||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.7670
71852488|NCT00318591|143218948|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANOVA. Level of significant difference \<0.05||||||0.0074||95.0||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA|||||||0.0074
71852489|NCT01612221|143218954|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||.65
71852490|NCT01612221|143218955|SUPERIORITY|||||||0.76|||||||ANCOVA|||GCLM Biomarker analysis.||||0.76
71852491|NCT01612221|143218955|SUPERIORITY|||||||0.63|||||||ANCOVA|||SLC1A4 Biomarker analysis.||||0.63
71852492|NCT01612221|143218955|SUPERIORITY|||||||0.27|||||||ANCOVA|||SLC7A11 Biomarker analysis.||||0.27
71852493|NCT00644332|143218986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in angina frequency from Baseline to Week 4||||
71852494|NCT00644332|143218987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|STANDARD_ERROR_OF_MEAN|0.5||||||||||||Mean change in NTG use from Baseline to Week 4||||
71852495|NCT00644332|143218988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|0.8||||||||||||||||
71852496|NCT02706834|143218999|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.43|||||TWO_SIDED|90.0|0.38|0.487|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.||0.487|0.380|
71852497|NCT02706834|143219006|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.896|||||TWO_SIDED|90.0|0.833|0.964|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.||0.964|0.833|
71852498|NCT00627523|143219017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|0.82|1.59||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference in the mean change from Baseline after 24 months in height SDS between the Genotropin® and the untreated control groups. The alternative hypothesis was that there was a difference between the treatment groups.||1.59|0.82|<0.001
71852499|NCT00627523|143219018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-0.87|2.42||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||2.42|-0.87|0.348
71852500|NCT00627523|143219019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|0.55|1.23||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||1.23|0.55|<0.001
71680092|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.65|||<|0.001|TWO_SIDED|95.0|1.28|2.14|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 10A||2.14|1.28|<0.001
71680093|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.52|||<|0.001|TWO_SIDED|95.0|1.2|1.92|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 11A||1.92|1.20|<0.001
71852501|NCT00627523|143219020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|1.63|4.85||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.85|1.63|<0.001
71852502|NCT00627523|143219021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|7.19||0.738|TWO_SIDED|95.0|-12.27|17.12||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||17.12|-12.27|0.738
71852503|NCT00627523|143219022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.51|STANDARD_ERROR_OF_MEAN|4.27||0.301|TWO_SIDED|95.0|-13.27|4.26||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.||4.26|-13.27|0.301
71852504|NCT03451292|143219027|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.17|TWO_SIDED|95.0|0.58|1.1|||Cox Proportional- Hazards (PH) model|||Stratification factors included were the region (Europe or North America) and history of hospitalization for acute decompensation of liver cirrhosis (yes or no).||1.10|0.58|0.17
71852505|NCT03602053|143219063|NON_INFERIORITY|If the lower limit of the 95% CI of the ratio of GMCs between the ROTAVAC 5D® and ROTAVAC® groups was larger than 1/2 (i.e. \> 0.5), ROTAVAC 5D® would be considered non-inferior to ROTAVAC®.|GMC ratio|1.294|||||TWO_SIDED|95.0|0.862|1.924|||t-test, 2 sided|||||1.924|0.862|
71852506|NCT01882088|143219125|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-06|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.000002
71852507|NCT01882088|143219126|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||0.2
71852508|NCT01882088|143219127|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.002415|||||||Wilcoxon (Mann-Whitney)|||||||0.002415
71852509|NCT01882088|143219128|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.000438|||||||Wilcoxon (Mann-Whitney)|||||||0.000438
71820753|NCT02204293|143143586|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|26.5||||0.1642|TWO_SIDED|95.0|-6.6|56.0|||Fisher Exact|||DAS28 (CRP) LDA||56.0|-6.6|0.1642
71820754|NCT02204293|143143587|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|21.6||||0.2285|TWO_SIDED|95.0|-8.1|49.9|||Fisher Exact|||DAS28 (ESR) remission||49.9|-8.1|0.2285
71820755|NCT02204293|143143587|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|27.1||||0.1212|TWO_SIDED|95.0|-4.6|54.6|||Fisher Exact|||DAS28 (CRP) Remission||54.6|-4.6|0.1212
71820756|NCT02204293|143143587|SUPERIORITY|Fisher's exact test with a two-tailed level of significance of α = 0.05.|Difference in Response Rates|16.0||||0.4018|TWO_SIDED|95.0|-12.6|43.4|||Fisher Exact|||Extended Remission||43.4|-12.6|0.4018
71820757|NCT00598481|143143668|SUPERIORITY|||||||0.005|||||||One-sided Poisson-regression|||||||0.005
71820758|NCT00598481|143143669|SUPERIORITY||Geometric mean ratio|3.0||||0.003|TWO_SIDED|95.0|1.45|6.19||P value related to geometric mean ratio at 1 year post gene therapy compared to baseline|Mixed Model Repeated Measures|||||6.19|1.45|0.003
71820759|NCT00598481|143143669|SUPERIORITY||Geometric mean ratio|5.4|||<|0.001|TWO_SIDED|95.0|2.63|11.25||P value related to geometric mean ratio at 2 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||11.25|2.63|<0.001
71820760|NCT00598481|143143669|SUPERIORITY||Geometric mean ratio|6.5|||<|0.001|TWO_SIDED|95.0|3.08|13.64||P value related to geometric mean ratio at 3 years post gene therapy compared to baseline|Mixed Model Repeated Measures|||||13.64|3.08|<0.001
71820761|NCT01994720|143143672|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.067|TWO_SIDED|95.0|0.78|1.01||In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.|Regression, Cox|||Composite of stroke/MI/death||1.01|0.78|0.0670
71820762|NCT01994720|143143673|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.0462|TWO_SIDED|95.0|0.76|1.0||If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.|Regression, Cox|||Ischemic stroke||1.00|0.76|0.0462
71820763|NCT01994720|143143674|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.0928|TWO_SIDED|95.0|0.79|1.02|||Regression, Cox|||||1.02|0.79|0.0928
71820764|NCT01994720|143143675|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0771|TWO_SIDED|95.0|0.78|1.01|||Regression, Cox|||||1.01|0.78|0.0771
71820765|NCT01994720|143143676|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.3641|TWO_SIDED|95.0|0.83|1.67|||Regression, Cox|||||1.67|0.83|0.3641
71820766|NCT01994720|143143677|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.4828|TWO_SIDED|95.0|0.75|1.85|||Regression, Cox|||||1.85|0.75|0.4828
71820767|NCT01994720|143143678|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.5457|TWO_SIDED|95.0|0.67|2.14|||Regression, Cox|||||2.14|0.67|0.5457
71820768|NCT01994720|143143679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.1393|TWO_SIDED|95.0|0.85|1.02|||Regression, Logistic|||||1.02|0.85|0.1393
71820769|NCT01994720|143143680|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0342|TWO_SIDED|95.0|0.75|0.99|||Regression, Cox|||||0.99|0.75|0.0342
71820770|NCT01994720|143143681|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.8557|TWO_SIDED|95.0|0.55|2.06|||Regression, Cox|||||2.06|0.55|0.8557
71820771|NCT01994720|143143682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.2126|TWO_SIDED|95.0|0.77|1.06|||Regression, Cox|||||1.06|0.77|0.2126
71820772|NCT01994720|143143688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.4511|TWO_SIDED|95.0|0.52|1.34|||Regression, Cox|||PLATO Major bleeding||1.34|0.52|0.4511
71820773|NCT01994720|143143689|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26|||<|0.0001|TWO_SIDED|95.0|1.53|3.34|||Regression, Cox|||||3.34|1.53|<0.0001
71820774|NCT01991197|143143690|SUPERIORITY||U value|43.5||||0.648|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.648
71820775|NCT01991197|143143693|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71820776|NCT01991197|143143696|SUPERIORITY||U|29.5||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
71820777|NCT02216422|143143708|SUPERIORITY_OR_OTHER||Percentage of Participants|100.0|||||TWO_SIDED|95.0|90.4|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|||100.0|90.4|
71820778|NCT04285229|143143711|SUPERIORITY||Odds Ratio (OR)|7.64|||<|0.001|TWO_SIDED|95.0|2.68|21.76|||Regression, Logistic|||||21.76|2.68|<0.001
71820779|NCT04285229|143143712|SUPERIORITY||Odds Ratio (OR)|6.4|||<|0.001|TWO_SIDED|95.0|2.42|16.9|||Regression, Logistic|||||16.90|2.42|<0.001
71820780|NCT04285229|143143713|SUPERIORITY||Odds Ratio (OR)|2.58||||0.006|TWO_SIDED|95.0|1.31|5.09|||Regression, Logistic|||||5.09|1.31|0.006
71820781|NCT04285229|143143714|SUPERIORITY||LS Mean Difference|-1.14|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-1.38|-0.9|||Mixed Models Analysis|||||-0.90|-1.38|<0.001
71820782|NCT04285229|143143715|SUPERIORITY||LS Mean Difference|-1.49|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.04|-0.94|||Mixed Models Analysis|||||-0.94|-2.04|<0.001
71680094|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.97|||<|0.001|TWO_SIDED|95.0|1.43|2.72|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 12F||2.72|1.43|<0.001
71820783|NCT04285229|143143716|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.28||0.002|TWO_SIDED|95.0|-1.43|-0.32|||Mixed Models Analysis|||||-0.32|-1.43|0.002
71820784|NCT04285229|143143717|SUPERIORITY||LS Mean Difference|-7.72|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-10.85|-4.6|||ANCOVA|||||-4.60|-10.85|<0.001
71820785|NCT04285229|143143718|SUPERIORITY||LS Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.785||0.001|TWO_SIDED|95.0|1.07|4.17|||Mixed Models Analysis|||||4.17|1.07|0.001
71820786|NCT04285229|143143719|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.152||0.66|TWO_SIDED|95.0|-1.77|2.79|||Mixed Models Analysis|||||2.79|-1.77|0.660
71820787|NCT04285229|143143720|SUPERIORITY||LS Mean Difference|-12.75|STANDARD_ERROR_OF_MEAN|1.594|<|0.001|TWO_SIDED|95.0|-15.91|-9.59|||Mixed Models Analysis|||||-9.59|-15.91|<0.001
71820788|NCT04285229|143143721|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.106|<|0.001|TWO_SIDED|95.0|-0.57|-0.15|||Mixed Models Analysis|||||-0.15|-0.57|<0.001
71820789|NCT04285229|143143722|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.413||0.086|TWO_SIDED|95.0|-1.54|0.1|||Mixed Models Analysis|||||0.10|-1.54|0.086
71820790|NCT04285229|143143723|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.034|<|0.001|TWO_SIDED|95.0|-7.71|-3.62|||ANCOVA|||||-3.62|-7.71|<0.001
71820791|NCT02397460|143143728|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects on Emax following capsaicin challenge were modeled for dose dependence and were estimated on the basis of disease status for participants who were healthy or had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
71820792|NCT02397460|143143729|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment effects following capsaicin challenge were modeled for dose. dependence and were estimated on the basis of disease status for participants who had chronic cough and received gefapixant 50 mg, gefapixant 300 mg, or placebo.||||< 0.0001
71820793|NCT01168674|143143744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.57|STANDARD_DEVIATION|1.67||0.48|TWO_SIDED||||||Mixed Models Analysis||The report is of the mean MADRS difference between ziprasidone versus placebo after linear mixed regression, correcting for confounding effects of order of treatment as well as other identified potential confounders.|Linear mixed effects regression model||||0.48
71820794|NCT02584855|143143746|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.||||<0.001
71820795|NCT02584855|143143747|SUPERIORITY||Odds Ratio (OR)|-45.6|||||TWO_SIDED|95.0|-58.8|-32.3||||||Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .||-32.3|-58.8|
71820796|NCT02584855|143143750|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
71820797|NCT02584855|143143751|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
71820798|NCT02584855|143143752|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
71820799|NCT02584855|143143753|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
71820800|NCT02584855|143143754|SUPERIORITY||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.||||<0.001
71820801|NCT02138747|143143759|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.997||0.004|TWO_SIDED|95.0|-4.86|-0.93||p-value based on the ANOVA model|ANOVA|||Tolerability score was analyzed using the ANOVA model (Model #1), with sequence group, study period, period-by-sequence interaction, gender and treatment group as factors, and subject-within-sequence as a random term. p-value based on the ANOVA model. Difference used mirabegron as the reference (difference =tolterodine ER -mirabegron). A negative difference indicates better reported tolerability with mirabegron than with tolterodine ER.||-0.93|-4.86|0.004
71820802|NCT02138747|143143760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P value was obtained using Mainland-Gart test to compare the proportion of preference for each treatment group. The denominator excluded patients with No Preference.|Mainland-Gart|||Participants who selected Mirabegron or Tolterodine ER were included in the denominator and participants with No Preference were excluded. Comparison was between Mirabegron vs Tolterodine ER.||||0.77
71820803|NCT02138747|143143769|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.224||0.971|TWO_SIDED|95.0|-0.39|0.49||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.49|-0.39|0.971
71820804|NCT02138747|143143770|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.199||0.211|TWO_SIDED|95.0|-0.28|0.5||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER - mirabegron).||0.50|-0.28|0.211
71820805|NCT04793464|143143795|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.26|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.26
71902691|NCT03238235|143327009|SUPERIORITY||Difference of Least Square Means|-2.23||||0.8846|TWO_SIDED|95.0|-33.05|28.59||ANCOVA model was performed considering baseline biopsy histological parameters (Slide II) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||Total number of fibers at Visit 11 (slide II)||28.59|-33.05|0.8846
71902692|NCT03238235|143327009|SUPERIORITY||Difference of Least Square Means|4.72||||0.4054|TWO_SIDED|95.0|-6.62|16.06||ANCOVA model was performed considering baseline biopsy histological parameters (Slide III) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||Total number of fibers (Slide III)||16.06|-6.62|0.4054
71902693|NCT03238235|143327010|SUPERIORITY||Difference of Least Square Means|2.45||||0.634|TWO_SIDED|95.0|-7.87|12.77||ANCOVA model was performed considering baseline Biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables|ANCOVA|||||12.77|-7.87|0.6340
71820806|NCT04793464|143143796|SUPERIORITY||Mean Difference (Final Values)|0.87||||0.02|TWO_SIDED||||||ANCOVA|Ratio of Means||Number analyzed is the number of participants with valid baseline and follow-up data.||||.02
71902694|NCT03238235|143327011|SUPERIORITY||Log Difference of Least Square Means|-0.14||||0.4893|TWO_SIDED|95.0|-0.54|0.26|||ANCOVA|||||0.26|-0.54|0.4893
71820807|NCT04793464|143143797|SUPERIORITY||Odds Ratio (OR)|1.1||||0.68|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.68
71820808|NCT04793464|143143798|SUPERIORITY||Odds Ratio (OR)|1.19||||0.44|TWO_SIDED||||||ANCOVA|Logistic regression||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
71820809|NCT04793464|143143799|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.77|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.77
71820810|NCT04793464|143143800|SUPERIORITY||Mean Difference (Final Values)|0.017||||0.66|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.66
71820811|NCT04793464|143143801|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.44|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||.44
71820812|NCT04793464|143143802|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.017|TWO_SIDED||||||ANCOVA|||Number analyzed is the number of participants with valid baseline and follow-up data.||||0.017
71820813|NCT00050089|143143890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.165||||0.69|TWO_SIDED|95.0|0.856|1.585|||Log Rank||The comparison was Mega-ART (intensification) vs Standard-ART (standard).|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.585|0.856|0.69
71820814|NCT00050089|143143891|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.49|TWO_SIDED|95.0|0.674|1.275|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation)|Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed.||1.275|0.674|0.49
71820815|NCT00050089|143143892|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Log Rank|||Stratified Log-rank test was used to compare the four treatment||||0.87
71902695|NCT03238235|143327012|SUPERIORITY||Log Difference of Least Square Means|-0.34||||0.1498|TWO_SIDED|95.0|-0.81|0.13||This model was performed considering baseline biopsy histological parameters (Slide I) value as covariate, treatment and concomitant steroid use at baseline as independent class variables.|ANCOVA|||||0.13|-0.81|0.1498
71902696|NCT03238235|143327013|SUPERIORITY||Log Difference of Least Square Means|0.06||||0.0602|TWO_SIDED|95.0|0.0|0.13||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Standing and transfers (D1) at Visit 11||0.13|-0.00|0.0602
71902697|NCT03238235|143327013|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.5906|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Axial and proximal motor function (D2) at Visit 11||0.01|-0.01|0.5906
71820816|NCT00050089|143143893|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.92|TWO_SIDED|95.0|0.75|1.35|||Log Rank||The comparison was Standard-ART (standard) vs Mega-ART (intensification)|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison||1.35|0.75|0.92
71820817|NCT00050089|143143894|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.68|TWO_SIDED|95.0|0.8|1.46|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.||1.46|0.8|0.68
71820818|NCT01216293|143143902|SUPERIORITY_OR_OTHER_LEGACY||Difference|19.2|||||TWO_SIDED|95.0|7.0|30.2|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.2|7.0|
71820819|NCT01216293|143143902|SUPERIORITY_OR_OTHER_LEGACY||Difference|18.2|||||TWO_SIDED|95.0|6.7|30.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||30.4|6.7|
71820820|NCT01216293|143143903|SUPERIORITY_OR_OTHER_LEGACY||Difference|27.366|||||TWO_SIDED|95.0|12.749|42.957|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||42.957|12.749|
71820821|NCT01216293|143143903|SUPERIORITY_OR_OTHER_LEGACY||Difference|22.025|||||TWO_SIDED|95.0|8.357|35.714|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||35.714|8.357|
71902698|NCT03238235|143327013|SUPERIORITY||Log Difference of Least Square Means|0.0||||0.7799|TWO_SIDED|95.0|-0.01|0.01||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Distal motor function (D3) at Visit 11||0.01|-0.01|0.7799
71820822|NCT01216293|143143904|SUPERIORITY_OR_OTHER_LEGACY||Difference|20.1|||||TWO_SIDED|95.0|4.0|34.4|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||34.4|4.0|
71820823|NCT01216293|143143904|SUPERIORITY_OR_OTHER_LEGACY||Difference|11.6|||||TWO_SIDED|95.0|-2.7|28.3|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||28.3|-2.7|
71820824|NCT01216293|143143905|SUPERIORITY_OR_OTHER_LEGACY||Difference|6.83|||||TWO_SIDED|95.0|0.4|12.78|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.78|0.40|
71820825|NCT01216293|143143905|SUPERIORITY_OR_OTHER_LEGACY||Difference|7.23|||||TWO_SIDED|95.0|0.59|12.86|||||Difference estimated using Hodges-Lehmann estimation, and corresponding 95% CIs calculated using Moses method.|||12.86|0.59|
71820826|NCT01671748|143143923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.4||||0.565|TWO_SIDED|95.0|-33.4|18.6||ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients' baseline (week 5) wound area was used as the covariate.|ANCOVA|||The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.||18.6|-33.4|0.565
71820827|NCT01671748|143143924|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANCOVA|||ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).||||0.490
71820828|NCT01671748|143143925|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.08||||0.078|TWO_SIDED|95.0|-19.23|1.06|||ANCOVA|||ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).||1.06|-19.23|0.078
71820829|NCT01671748|143143926|SUPERIORITY_OR_OTHER|||||||0.346|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.||||0.346
71820830|NCT01671748|143143928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.618|TWO_SIDED|95.0|-4.7|2.9|||ANCOVA|Patients' baseline (week 5) wound area was used as the covariate.||||2.9|-4.7|0.618
71820831|NCT03615482|143143931|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-0.9||||0.617|TWO_SIDED|95.0|-4.5|2.7|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Erythema||2.7|-4.5|0.617
71820832|NCT03615482|143143931|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.6||||0.32|TWO_SIDED|95.0|-7.8|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Pain||2.6|-7.8|0.320
71820833|NCT03615482|143143931|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.1||||0.31|TWO_SIDED|95.0|-6.2|2.0|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Injection-Site Swelling||2.0|-6.2|0.310
71820834|NCT03615482|143143932|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.205|TWO_SIDED|95.0|-5.8|1.2|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Arthralgia||1.2|-5.8|0.205
71852510|NCT01882088|143219129|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
71820835|NCT03615482|143143932|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.9||||0.273|TWO_SIDED|95.0|-8.0|2.3|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Fatigue||2.3|-8.0|0.273
71820836|NCT03615482|143143932|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|-2.2||||0.372|TWO_SIDED|95.0|-6.9|2.6|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Headache||2.6|-6.9|0.372
71820837|NCT03615482|143143932|OTHER|Difference in Percent vs. Non-concomitant Group|Difference in Percent|2.4||||0.329|TWO_SIDED|95.0|-2.4|7.1|||Miettinen & Nurminen|Estimated differences, confidence intervals (CIs), and p-values were calculated based on Miettinen \& Nurminen method.||Myalgia||7.1|-2.4|0.329
71820838|NCT03615482|143143933|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.6|0.6||||||||0.6|-0.6|
71820839|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.66||||0.004|TWO_SIDED|95.0|0.54|0.82|||cLDA|GMT ratio, 95% CI and p-value were estimated from a constrained longitudinal data analysis (cLDA) model including all vaccinated participants.||Serotype 1||0.82|0.54|0.004
71820840|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.81|1.09|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 3||1.09|0.81|<0.001
71820841|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.69|1.01|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 4||1.01|0.69|<0.001
71820842|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.64|0.98|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 5||0.98|0.64|<0.001
71820843|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.84|||<|0.001|TWO_SIDED|95.0|0.71|1.0|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6A||1.00|0.71|<0.001
71820844|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.88|||<|0.001|TWO_SIDED|95.0|0.74|1.04|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 6B||1.04|0.74|<0.001
71820845|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.86|||<|0.001|TWO_SIDED|95.0|0.75|0.99|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 7F||0.99|0.75|<0.001
71820846|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.99|||<|0.001|TWO_SIDED|95.0|0.86|1.15|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 9V||1.15|0.86|<0.001
71820847|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 14||1.08|0.77|<0.001
71820848|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.79|||<|0.001|TWO_SIDED|95.0|0.68|0.92|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 18C||0.92|0.68|<0.001
71820849|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19A||0.95|0.73|<0.001
71820850|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 19F||1.17|0.89|<0.001
71820851|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.77|||<|0.001|TWO_SIDED|95.0|0.64|0.91|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 22F||0.91|0.64|<0.001
71820852|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.7|1.03|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 23F||1.03|0.70|<0.001
71820853|NCT03615482|143143934|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.72|0.96|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||Serotype 33F||0.96|0.72|<0.001
71820854|NCT03615482|143143935|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.25|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H1N1||1.25|0.94|<0.001
71902699|NCT03238235|143327013|SUPERIORITY||Log Difference of Least Square Means|0.01||||0.1116|TWO_SIDED|95.0|0.0|0.03||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Total Score at Visit 11||0.03|-0.00|0.1116
71820855|NCT03615482|143143935|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||H3N2||1.17|0.90|<0.001
71820856|NCT03615482|143143935|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.86|1.08|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Victoria||1.08|0.86|<0.001
71820857|NCT03615482|143143935|NON_INFERIORITY|Non-inferiority is based on the lower bound of the 95% confidence interval (CI) on the estimated GMT ratio (Concomitant Group/Nonconcomitant Group) being \>0.5 (one-sided p-value \< 0.025).|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.13|||cLDA|GMT ratio, 95% CI and p-value were estimated from a cLDA model.||B-Yamagata||1.13|0.90|<0.001
71820858|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.89||||||Serotype 1||0.89|0.67|
71820859|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.87|||||TWO_SIDED|95.0|0.76|0.99||||||Serotype 3||0.99|0.76|
71820860|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 4||0.91|0.68|
71902700|NCT03238235|143327014|SUPERIORITY||Log Difference of Least Square Means|-0.07||||0.4346|TWO_SIDED|95.0|-0.23|0.1||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Time to Walk/Run 10 meters at Visit 11||0.10|-0.23|0.4346
71902701|NCT03238235|143327015|SUPERIORITY||Log Difference of Least Square Means|-0.02||||0.8914|TWO_SIDED|95.0|-0.32|0.28|||Mixed Models Analysis|||Time to climb 4 standard steps (sec) at visit 11||0.28|-0.32|0.8914
71820861|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 5||1.02|0.77|
71902702|NCT03238235|143327016|SUPERIORITY||Difference of Least Square Means|0.62||||0.7629|TWO_SIDED|95.0|-3.51|4.75||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|Mixed Models Analysis|||Time to rise from floor at Visit 11||4.75|-3.51|0.7629
71902703|NCT03238235|143327017|SUPERIORITY||Log Difference of Least Square Means|-0.01||||0.8106|TWO_SIDED|95.0|-0.11|0.08||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate|Mixed Models Analysis|||Maximum distance walked after 6 minutes at Visit 11||0.08|-0.11|0.8106
71820862|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.61|0.87||||||Serotype 6A||0.87|0.61|
71820863|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.64|0.91||||||Serotype 6B||0.91|0.64|
71820864|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.01||||||Serotype 7F||1.01|0.76|
71820865|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03||||||Serotype 9V||1.03|0.79|
71902704|NCT03238235|143327018|SUPERIORITY|||||||0.1626||||||P-value is obtained from the two-sided Cochran-Mantel-Haenszel chi-squared test, stratified for concomitant steroid use at baseline|Cochran-Mantel-Haenszel|||\<10% worsening at visit 11||||0.1626
71902705|NCT03238235|143327021|SUPERIORITY||Difference of Least Square Means|3.57||||0.5099|TWO_SIDED|95.0|-7.27|14.41||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Knee Extension (N) at Visit 11||14.41|-7.27|0.5099
71902706|NCT03238235|143327021|SUPERIORITY||Difference of Least Square Means|1.16||||0.7355|TWO_SIDED|95.0|-5.73|8.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Knee Extension (N) at Visit 11||8.06|-5.73|0.7355
71902707|NCT03238235|143327021|SUPERIORITY||Difference of Least Square Means|3.92||||0.6037|TWO_SIDED|95.0|-11.22|19.06||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Left Elbow Flexion (N) at Visit 11||19.06|-11.22|0.6037
71902708|NCT03238235|143327021|SUPERIORITY||Difference of Least Square Means|4.1||||0.6178|TWO_SIDED|95.0|-12.35|20.55||Least squares mean is obtained from the mixed effects model for repeated measures with treatment, visit, visit by treatment interaction and concomitant steroid use at baseline as fixed effect; baseline value is included as a covariate.|ANCOVA|||Right Elbow Flexion (N) at Visit 11||20.55|-12.35|0.6178
71902709|NCT03238235|143327024|SUPERIORITY||log difference of Least Square Means|-0.03||||0.1165|TWO_SIDED|95.0|-0.06|0.01||ANCOVA model was performed considering baseline fat fraction of lower limb muscles value as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Medial Thigh at visit 11||0.01|-0.06|0.1165
71820866|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 14||0.99|0.73|
71820867|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.91||||||Serotype 18C||0.91|0.68|
71820868|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 19A||1.02|0.78|
71820869|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03||||||Serotype 19F||1.03|0.77|
71820870|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.76|||||TWO_SIDED|95.0|0.65|0.89||||||Serotype 22F||0.89|0.65|
71820871|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|0.98||||||Serotype 23F||0.98|0.70|
71820872|NCT03615482|143143936|OTHER|GMC ratio and 95% CI were estimated from cLDA model.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.75|0.99||||||Serotype 33F||0.99|0.75|
71820873|NCT01500226|143143954|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.2|2.0||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.2|<0.001
71820874|NCT01500226|143143955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.143|TWO_SIDED|95.0|0.9|1.6||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||1.6|0.9|0.143
71820875|NCT01500226|143143956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.3|2.0||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.||||2.0|1.3|<0.001
71820876|NCT01603940|143143959|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.616
71852511|NCT01882088|143219130|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71852512|NCT01882088|143219131|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71852513|NCT01882088|143219132|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71852514|NCT01882088|143219133|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71852515|NCT01882088|143219134|EQUIVALENCE|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-05|||||||Wilcoxon (Mann-Whitney)|||||||0.00002
71852516|NCT00125619|143219136|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.||||0.72
71852517|NCT00125619|143219136|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Robot (Lokomat) training.||||<.05
71852518|NCT00125619|143219136|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.||||>.05
71852519|NCT00125619|143219137|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of Robot vs. Manual training.||||>0.05
71852520|NCT00125619|143219137|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.||||>.05
71852521|NCT00125619|143219137|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.||||<.05
71852522|NCT00125619|143219138|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of robot vs. manual training.||||>.05
71852523|NCT00125619|143219138|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects for manual training.||||>.05
71852524|NCT00125619|143219138|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon signed ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||>.05
71852525|NCT00125619|143219139|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of effects of robot vs. manual training.||||>.05
71852526|NCT00125619|143219139|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison of pre- vs. post-treatment effects of manual training.||||>.05
71820877|NCT01603940|143143960|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.28
71852527|NCT00125619|143219139|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of robot training.||||<.05
71852528|NCT00125619|143219140|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
71852529|NCT00125619|143219140|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within groups comparison for pre- vs. post-training effects of manual training.||||>.05
71852530|NCT00125619|143219140|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within group comparison for pre- vs. post-training effects of robot training.||||>.05
71852531|NCT00125619|143219141|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
71852532|NCT00125619|143219141|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||>.05
71852533|NCT00125619|143219141|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
71820878|NCT01603940|143143961|SUPERIORITY_OR_OTHER|||||||0.618|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.618
71820879|NCT01474512|143144000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820880|NCT01474512|143144000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820881|NCT01474512|143144001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820882|NCT01474512|143144001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820883|NCT01474512|143144002|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
71820884|NCT01474512|143144002|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.||||||<0.001
71820885|NCT01474512|143144003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820886|NCT01474512|143144003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820887|NCT01474512|143144003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
71820888|NCT01474512|143144003|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.||||||<0.001
71820889|NCT01474512|143144004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
71820890|NCT01474512|143144004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.||||||<0.001
71820891|NCT01474512|143144005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820892|NCT01474512|143144005|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820893|NCT01474512|143144006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820894|NCT01474512|143144006|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820895|NCT01474512|143144007|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820896|NCT01474512|143144007|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820897|NCT01474512|143144008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71852534|NCT00125619|143219142|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.||||>.05
71852535|NCT00125619|143219142|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.||||<.05
71680095|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.6|||<|0.001|TWO_SIDED|95.0|1.28|2.0|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 17F||2.00|1.28|<0.001
71820898|NCT01474512|143144008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820899|NCT01474512|143144009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820900|NCT01474512|143144009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71852536|NCT00125619|143219142|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.||||<.05
71852537|NCT00168805|143219145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-1.3||||0.6648||95.0|-7.3|4.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.6|-7.3|0.6648
71852538|NCT00168805|143219145|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|2.8||||0.3553||95.0|-3.1|8.7||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.7|-3.1|0.3553
71852539|NCT00168805|143219146|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.0||||0.376||95.0|-3.1|1.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.2|-3.1|0.3760
71852540|NCT00168805|143219146|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.8151||95.0|-2.0|2.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.6|-2.0|0.8151
71852541|NCT00168805|143219147|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.8||||0.4715||95.0|-2.8|1.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||1.3|-2.8|0.4715
71852542|NCT00168805|143219147|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.1||||0.9325||95.0|-2.1|2.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||2.3|-2.1|0.9325
71852543|NCT00168805|143219148|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-1.4||||0.6463||95.0|-7.3|4.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||4.5|-7.3|0.6463
71852544|NCT00168805|143219148|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|2.7||||0.374||95.0|-3.2|8.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin||8.6|-3.2|0.3740
71820901|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for Absenteeism.||||||<0.001
71852545|NCT00168805|143219149|SUPERIORITY_OR_OTHER|||||||0.0385||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.0385
71852546|NCT00168805|143219149|SUPERIORITY_OR_OTHER|||||||0.1414||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.1414
71852547|NCT00168805|143219150|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71852548|NCT00168805|143219150|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71852549|NCT00168805|143219151|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71852550|NCT00168805|143219151|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71852551|NCT00168805|143219153|SUPERIORITY_OR_OTHER|||||||0.8209||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||0.8209
71852552|NCT00168805|143219153|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison versus Enoxaparin||||1.0000
71852553|NCT04879823|143219157|SUPERIORITY|||||||0.03|||||||t-test, 1 sided|||Null hypothesis: Average pain scores before medication will not be lower in the dexamethasone group compared with the placebo group.||||0.03
71852554|NCT04879823|143219158|SUPERIORITY|||||||0.07|||||||Fisher Exact|||Null hypothesis: There will be no difference in the proportion of patients visiting the emergency department or urgent care (at least 1 time) post-operatively between dexamethasone and placebo groups.||||0.07
71852555|NCT04879823|143219159|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: Average pain scores after medication will not be lower in the dexamethasone group compared with the placebo group.||||0.98
71852556|NCT03897075|143219173|SUPERIORITY|||||||0.00311|||||||Cochran-Mantel-Haenszel|||||||0.00311
71852557|NCT03897075|143219174|SUPERIORITY|||||||0.00079|||||||Cochran-Mantel-Haenszel|||||||0.00079
71852558|NCT03897075|143219175|SUPERIORITY|||||||0.09892|||||||Cochran-Mantel-Haenszel|||||||0.09892
71852559|NCT04468633|143219184|OTHER|||||||0.687|||||||t-test, 2 sided|||Baseline||||0.687
71852560|NCT04468633|143219184|OTHER|||||||0.384|||||||t-test, 2 sided|||Day 1||||0.384
71852561|NCT04468633|143219184|OTHER|||||||0.597|||||||t-test, 2 sided|||Week 1||||0.597
71820902|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for absenteeism.||||||0.003
71820903|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
71820904|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.||||||<0.001
71820905|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
71852562|NCT04468633|143219184|OTHER|||||||0.86|||||||t-test, 2 sided|||Week 4||||0.860
71820906|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.||||||<0.001
71820907|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
71820908|NCT01474512|143144010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.||||||<0.001
71820909|NCT01474512|143144011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
71820910|NCT01474512|143144011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA|||||||<0.001
71820911|NCT01474512|143144012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
71820912|NCT01474512|143144012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.||||||<0.001
71820913|NCT01474512|143144012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
71820914|NCT01474512|143144012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.||||||<0.001
71820915|NCT01474512|143144013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820916|NCT01474512|143144013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71820917|NCT01474512|143144014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820918|NCT01474512|143144014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820919|NCT01474512|143144014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820920|NCT01474512|143144014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71852563|NCT04468633|143219184|OTHER|||||||0.032|||||||t-test, 2 sided|||Week 6||||0.032
71852564|NCT04468633|143219184|OTHER|||||||0.026|||||||t-test, 2 sided|||Month 3||||0.026
71852565|NCT04468633|143219184|OTHER|||||||0.172|||||||t-test, 2 sided|||Month 6||||0.172
71852566|NCT04468633|143219184|OTHER|||||||0.01|||||||t-test, 2 sided|||Year 1||||0.010
71852567|NCT04468633|143219188|OTHER|||||||0.759|||||||Wilcoxon rank sum test|||||||0.759
71852568|NCT04468633|143219189|OTHER|||||||0.603|||||||Wilcoxon rank sum test|||||||0.603
71852569|NCT04468633|143219198|OTHER|||||||0.833|||||||Wilcoxon rank sum test|||||||0.833
71680096|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|0.93|1.45|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 19A||1.45|0.93|<0.001
71680097|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.44|||<|0.001|TWO_SIDED|95.0|1.18|1.77|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 20A||1.77|1.18|<0.001
71680098|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.39|||<|0.001|TWO_SIDED|95.0|1.1|1.76|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 22F||1.76|1.10|<0.001
71680099|NCT05633992|142877961|NON_INFERIORITY|For the 12 serotypes common to both V116 and PPSV23, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|0.87|||<|0.001|TWO_SIDED|95.0|0.68|1.12|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 33F||1.12|0.68|<0.001
71680100|NCT05633992|142877961|NON_INFERIORITY|For serotype 15B, a conclusion of non-inferiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>0.5 (one-sided p-value \<0.025).|Day 30 GMT Ratio|1.43|||<|0.001|TWO_SIDED|95.0|1.07|1.89|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15B||1.89|1.07|<0.001
71680101|NCT05633992|142877961|SUPERIORITY|For serotype 15C, a conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the OPA GMT ratio (V116/PPSV23) to be \>1.0 (one-sided p-value \<0.025).|Day 30 GMT Ratio|2.05|||<|0.001|TWO_SIDED|95.0|1.56|2.7|||Constrained Longitudinal Data Analysis|cLDA model with terms for vaccination group, time, interaction of time-by-vaccination, age stratum at baseline, and interaction of time-by-age stratum|Ratio is V116/PPSV23. GMT ratio and confidence interval estimated from the cLDA model. The cLDA model-based ratio includes estimated data for participants who had baseline data available but no day 30 measurement.|Serotype 15C||2.70|1.56|<0.001
71680102|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.6|||<|0.001|TWO_SIDED|95.0|17.8|36.9|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 6A||36.9|17.8|<0.001
71852570|NCT00472199|143219224|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.0||0.0077||95.0|-4.6|-0.7|||ANCOVA|||Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate||-0.7|-4.6|0.0077
71852571|NCT00472199|143219225|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0010
71852572|NCT00472199|143219226|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||Cochran-Mantel-Haenszel|||||||0.0044
71852573|NCT00472199|143219227|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Cochran-Mantel-Haenszel|||||||0.0011
71852574|NCT00472199|143219228|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.0489||95.0|-1.1|-0.9|||Wilcoxon (Mann-Whitney)|||||-0.9|-1.1|0.0489
71680103|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.0|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 15A||43.0|23.6|<0.001
71680104|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.8|46.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 16F||46.4|29.8|<0.001
71680105|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|29.5|||<|0.001|TWO_SIDED|95.0|17.4|40.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23A||40.6|17.4|<0.001
71852575|NCT00472199|143219229|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0315|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0315
71852576|NCT00472199|143219230|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0735|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0735
71852577|NCT00472199|143219231|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.841|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8410
71852578|NCT00472199|143219232|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.9241|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.9241
71852579|NCT00472199|143219233|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8093|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.8093
71852580|NCT00472199|143219234|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0583|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0.0|-0.0|0.0583
71852581|NCT00472199|143219235|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-5.0||||0.0916|TWO_SIDED|95.0|-5.5|-4.5|||Wilcoxon (Mann-Whitney)|||||-4.5|-5.5|0.0916
71852582|NCT00472199|143219236|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.5||||0.5905|TWO_SIDED|95.0|2.2|2.8|||Wilcoxon (Mann-Whitney)|||||2.8|2.2|0.5905
71852583|NCT00472199|143219237|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.0179|TWO_SIDED|95.0|1.6|2.4|||Wilcoxon (Mann-Whitney)|||||2.4|1.6|0.0179
71852584|NCT00472199|143219238|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.0||||0.545|TWO_SIDED|95.0|1.7|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|1.7|0.5450
71852585|NCT00472199|143219239|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.1456|TWO_SIDED|95.0|-0.3|0.3|||Wilcoxon (Mann-Whitney)|||||0.3|-0.3|0.1456
71852586|NCT00472199|143219240|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.2915|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.2915
71852587|NCT00472199|143219241|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.3131|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.3131
71852588|NCT00472199|143219242|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.5713|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.5713
71852589|NCT00472199|143219243|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.8432|TWO_SIDED|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)|||||0.4|-0.4|0.8432
71852590|NCT00472199|143219244|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.3||||0.0206|TWO_SIDED|95.0|5.9|6.6|||Wilcoxon (Mann-Whitney)|||||6.6|5.9|0.0206
71852591|NCT00472199|143219245|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.6||||0.5602|TWO_SIDED|95.0|0.4|0.8|||Wilcoxon (Mann-Whitney)|||||0.8|0.4|0.5602
71852592|NCT00472199|143219246|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.136|TWO_SIDED|95.0|0.8|1.1|||Wilcoxon (Mann-Whitney)|||||1.1|0.8|0.1360
71852593|NCT00472199|143219248|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Mantel Haenszel|||||||0.0022
71852594|NCT02446912|143219260|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-4.2||||0.412|TWO_SIDED|95.0|-14.2|5.8||Nominal p-value|Cochran-Mantel-Haenszel|||||5.8|-14.2|0.412
71852595|NCT02446912|143219260|SUPERIORITY||Mean Difference (Final Values)|-2.6|||||TWO_SIDED|95.0|-14.7|9.6||||||||9.6|-14.7|
71852596|NCT02446912|143219261|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.9||||0.455|TWO_SIDED|95.0|-6.3|14.1||Nominal p-value|Cochran-Mantel-Haenszel|||||14.1|-6.3|0.455
71852597|NCT02446912|143219261|SUPERIORITY||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-6.7|17.8||||||||17.8|-6.7|
71852598|NCT02446912|143219262|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|-3.4||||0.549|TWO_SIDED|95.0|-14.4|7.6||Nominal p-value|Cochran-Mantel-Haenszel|||||7.6|-14.4|0.549
71852599|NCT02446912|143219263|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|6.4||||0.261|TWO_SIDED|95.0|-4.8|17.7||Nominal p-value|Cochran-Mantel-Haenszel|||||17.7|-4.8|0.261
71852600|NCT02446912|143219264|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|8.9||||0.18|TWO_SIDED|95.0|-4.1|21.9||Nominal p-value|Cochran-Mantel-Haenszel|||||21.9|-4.1|0.180
71852601|NCT02446912|143219265|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.7||||0.013|TWO_SIDED|95.0|3.5|29.8||Nominal p-value|Cochran-Mantel-Haenszel|||||29.8|3.5|0.013
71902710|NCT03238235|143327025|SUPERIORITY||Log difference of Least Square Means|0.05||||0.1939|TWO_SIDED|95.0|-0.02|0.12||ANCOVA model was performed considering baseline CSA as covariate and treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Hamstrings at Visit 11||0.12|-0.02|0.1939
71820921|NCT01474512|143144014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value is for PPASI100|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820922|NCT01474512|143144014|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value if for PPASI100.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.||||||<0.001
71820923|NCT05454449|143144092|OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
71820924|NCT05454449|143144093|OTHER|||||||0.009|||||||t-test, 2 sided|||||||0.009
71820925|NCT05454449|143144094|OTHER|||||||0.082|||||||t-test, 2 sided|||||||0.082
71820926|NCT05454449|143144095|OTHER|||||||0.022|||||||t-test, 2 sided|||||||0.022
71820927|NCT05454449|143144096|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
71820928|NCT05454449|143144097|OTHER|||||||0.029|||||||t-test, 2 sided|||||||0.029
71820929|NCT05454449|143144098|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
71820930|NCT03249376|143144110|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.89|<|0.0001|TWO_SIDED|95.0|-6.34|-2.83|||Mixed Effects Model for Repeated Measure|||||-2.83|-6.34|<0.0001
71820931|NCT03249376|143144111|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.37|-0.51|||Mixed Effects Model for Repeated Measure|||||-0.51|-1.37|<0.0001
71820932|NCT03249376|143144112|SUPERIORITY||Least Squares Mean Difference|4.6||||0.005|TWO_SIDED|95.0|1.42|7.69|||ANCOVA|||||7.69|1.42|0.005
71820933|NCT01154036|143144120|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-12.7|||<|0.001|TWO_SIDED|95.0|-16.6|-8.7||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-8.7|-16.6|<0.001
71820934|NCT01154036|143144120|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimate|-9.1|||<|0.001|TWO_SIDED|95.0|-12.9|-5.4||The primary hypotheses were tested at 0.045, applying Hochberg's procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.4|-12.9|<0.001
71820935|NCT01154036|143144121|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.5|||<|0.001|TWO_SIDED|95.0|-15.9|-5.1||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.1|-15.9|<0.001
71820936|NCT01154036|143144121|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.5|||<|0.001|TWO_SIDED|95.0|-13.6|-5.5||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-5.5|-13.6|<0.001
71820937|NCT01154036|143144122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.62|3.89|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.89|1.62|<0.001
71820938|NCT01154036|143144122|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.77||||0.007|TWO_SIDED|95.0|1.17|2.67|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||2.67|1.17|0.007
71820939|NCT01154036|143144123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.71|||<|0.001|TWO_SIDED|95.0|1.55|4.73|||Logistic regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||4.73|1.55|<0.001
71820940|NCT01154036|143144123|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.38|||<|0.001|TWO_SIDED|95.0|1.56|3.63|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||3.63|1.56|<0.001
71820941|NCT01154036|143144124|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|9.46|||<|0.001|TWO_SIDED|95.0|4.56|19.62|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||19.62|4.56|<0.001
71820942|NCT01154036|143144124|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|2.23|6.82|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||6.82|2.23|<0.001
71820943|NCT01154036|143144125|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|27.77||||0.001|TWO_SIDED|95.0|3.64|211.83|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||211.83|3.64|0.001
71820944|NCT01154036|143144125|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|7.08|||<|0.001|TWO_SIDED|95.0|2.85|17.56|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)||||17.56|2.85|<0.001
71820945|NCT01154036|143144126|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.1|||<|0.001|TWO_SIDED|95.0|-9.7|-4.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.4|-9.7|<0.001
71820946|NCT01154036|143144126|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8|||<|0.001|TWO_SIDED|95.0|-8.3|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-8.3|<0.001
71820947|NCT01154036|143144127|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.8|||<|0.001|TWO_SIDED|95.0|-10.7|-3.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.0|-10.7|<0.001
71680106|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|38.3|||<|0.001|TWO_SIDED|95.0|29.3|46.7|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 23B||46.7|29.3|<0.001
71680107|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|27.1|||<|0.001|TWO_SIDED|95.0|18.3|35.6|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 24F||35.6|18.3|<0.001
71680108|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|57.3|||<|0.001|TWO_SIDED|95.0|49.3|64.4|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 31||64.4|49.3|<0.001
71820948|NCT01154036|143144127|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.4|||<|0.001|TWO_SIDED|95.0|-10.2|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-10.2|<0.001
71820949|NCT01154036|143144128|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|-2.1||||0.466|TWO_SIDED|95.0|-7.8|3.5|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||3.5|-7.8|0.466
71820950|NCT01154036|143144128|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares means|-4.9||||0.081|TWO_SIDED|95.0|-10.3|0.5|||Constrained Longitudinal Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||0.5|-10.3|0.081
71820951|NCT01154036|143144129|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-2.8||||0.466|TWO_SIDED|95.0|-10.2|4.7|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.7|-10.2|0.466
71820952|NCT01154036|143144129|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squarres Means|-7.1||||0.011|TWO_SIDED|95.0|-12.6|-1.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||-1.6|-12.6|0.011
71820953|NCT01154036|143144130|SUPERIORITY_OR_OTHER_LEGACY||Difference in M--estimates|1.7||||0.133|TWO_SIDED|95.0|-0.5|4.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||4.0|-0.5|0.133
71820954|NCT01154036|143144130|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.6||||0.61|TWO_SIDED|95.0|-2.7|1.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.6|-2.7|0.610
71820955|NCT01154036|143144131|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.52|TWO_SIDED|95.0|-4.2|2.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||2.1|-4.2|0.520
71820956|NCT01154036|143144131|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.7||||0.567|TWO_SIDED|95.0|-3.1|1.7|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.7|-3.1|0.567
71820957|NCT01154036|143144132|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.3||||0.003|TWO_SIDED|95.0|-8.8|-1.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.8|-8.8|0.003
71820958|NCT01154036|143144132|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.011|TWO_SIDED|95.0|-7.7|-1.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.0|-7.7|0.011
71820959|NCT01154036|143144133|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.3||||0.079|TWO_SIDED|95.0|-9.2|0.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.5|-9.2|0.079
71820960|NCT01154036|143144133|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.7|||<|0.001|TWO_SIDED|95.0|-11.4|-4.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.1|-11.4|<0.001
71820961|NCT01154036|143144134|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|1.6||||0.156|TWO_SIDED|95.0|-0.6|3.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.8|-0.6|0.156
71820962|NCT01154036|143144134|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-0.9||||0.425|TWO_SIDED|95.0|-2.9|1.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.2|-2.9|0.425
71820963|NCT01154036|143144135|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|0.5||||0.739|TWO_SIDED|95.0|-2.5|3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||3.6|-2.5|0.739
71820964|NCT01154036|143144135|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-1.0||||0.41|TWO_SIDED|95.0|-3.3|1.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||1.3|-3.3|0.410
71820965|NCT01154036|143144136|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.1|||<|0.001|TWO_SIDED|95.0|-13.6|-6.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.6|-13.6|<0.001
71820966|NCT01154036|143144136|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.6|||<|0.001|TWO_SIDED|95.0|-10.9|-4.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.3|-10.9|<0.001
71820967|NCT01154036|143144137|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.0|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.5|-14.0|<0.001
71820968|NCT01154036|143144137|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.8||||0.001|TWO_SIDED|95.0|-13.5|-6.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.2|-13.5|0.001
71820969|NCT01154036|143144138|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.1|||<|0.001|TWO_SIDED|95.0|-11.2|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-11.2|<0.001
71820970|NCT01154036|143144138|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-4.8||||0.001|TWO_SIDED|95.0|-7.8|-1.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-1.9|-7.8|0.001
71820971|NCT01154036|143144139|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.9|||<|0.001|TWO_SIDED|95.0|-11.0|-2.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.8|-11.0|<0.001
71820972|NCT01154036|143144139|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.4|||<|0.001|TWO_SIDED|95.0|-9.4|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.3|-9.4|<0.001
71820973|NCT01154036|143144140|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-13.7|||<|0.001|TWO_SIDED|95.0|-18.1|-9.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-9.3|-18.1|<0.001
71820974|NCT01154036|143144140|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-7.8|||<|0.001|TWO_SIDED|95.0|-11.9|-3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.6|-11.9|<0.001
71820975|NCT01154036|143144141|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.4|||<|0.001|TWO_SIDED|95.0|-15.8|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.9|-15.8|<0.001
71820976|NCT01154036|143144141|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.3|||<|0.001|TWO_SIDED|95.0|-12.5|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.5|<0.001
71820977|NCT01154036|143144142|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.3|||<|0.001|TWO_SIDED|95.0|-10.0|-2.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.5|-10.0|<0.001
71820978|NCT01154036|143144142|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-3.5||||0.052|TWO_SIDED|95.0|-7.1|0.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||0.0|-7.1|0.052
71820979|NCT01154036|143144143|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-5.8||||0.024|TWO_SIDED|95.0|-10.8|-0.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-0.8|-10.8|0.024
71902711|NCT03238235|143327026|SUPERIORITY||Log difference of Least Square Means|0.01||||0.9493|TWO_SIDED|95.0|-0.29|0.3||ANCOVA model was performed considering baseline biopsy histological parameters (slide III) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||CSA Type I||0.30|-0.29|0.9493
71902712|NCT03238235|143327027|SUPERIORITY||Log difference of Least Square Means|0.05||||0.6265|TWO_SIDED|95.0|-0.16|0.26||ANCOVA model was performed considering baseline biopsy histological parameters (slide I) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Total number of Fibers at Visit 11 (slide I)||0.26|-0.16|0.6265
71820980|NCT01154036|143144143|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.1||||0.002|TWO_SIDED|95.0|-9.9|-2.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.3|-9.9|0.002
71820981|NCT01154036|143144144|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-10.6|||<|0.001|TWO_SIDED|95.0|-14.9|-6.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-6.4|-14.9|<0.001
71902713|NCT03238235|143327027|SUPERIORITY||Log difference of Least Square Means|-0.44||||0.1562|TWO_SIDED|95.0|-1.05|0.17||ANCOVA model was performed considering baseline biopsy histological parameters (slide II) value as covariate, treatment and concomitant steroids use at baseline as independent class variables|ANCOVA|||Regenerative Fibers (%) at Visit 11||0.17|-1.05|0.1562
71820982|NCT01154036|143144144|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-6.2||||0.002|TWO_SIDED|95.0|-10.2|-2.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-2.2|-10.2|0.002
71902714|NCT05896761|143327031|OTHER||Ratio of geometric least square mean|0.926|||||TWO_SIDED|90.0|0.831|1.03||||||||1.03|0.831|
71902715|NCT05896761|143327031|OTHER||Ratio of geometric least square mean|0.929|||||TWO_SIDED|90.0|0.816|1.06||||||||1.06|0.816|
71852602|NCT02446912|143219266|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|17.0||||0.054|TWO_SIDED|95.0|-0.3|34.3||Nominal p-value|Cochran-Mantel-Haenszel|||||34.3|-0.3|0.054
71852603|NCT02446912|143219267|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|18.7||||0.034|TWO_SIDED|95.0|1.4|36.0||Nominal p-value|Cochran-Mantel-Haenszel|||||36.0|1.4|0.034
71852604|NCT02446912|143219268|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|0.6||||0.905|TWO_SIDED|95.0|-9.4|10.6||Nominal p-value|Cochran-Mantel-Haenszel|||||10.6|-9.4|0.905
71852605|NCT02446912|143219269|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|3.3||||0.515|TWO_SIDED|95.0|-6.7|13.4||Nominal p-value|Cochran-Mantel-Haenszel|||||13.4|-6.7|0.515
71852606|NCT02446912|143219270|SUPERIORITY|Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.|Rate Ratio|0.83||||0.258|TWO_SIDED|95.0|0.6|1.14||Nominal p-value|Negative binomial regression|||||1.14|0.60|0.258
71852607|NCT02446912|143219271|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|0.6|19.7|||Cochran-Mantel-Haenszel|||||19.7|0.6|
71852608|NCT02446912|143219272|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.4|||||TWO_SIDED|95.0|6.7|26.2|||Cochran-Mantel-Haenszel|||||26.2|6.7|
71852609|NCT00147745|143219288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.5499||95.0|-0.1|0.19|||ANCOVA|||||0.19|-0.10|0.5499
71852610|NCT00147745|143219288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5723||95.0|-0.23|0.13|||ANCOVA|||||0.13|-0.23|0.5723
71852611|NCT00147745|143219288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.091||0.3138||95.0|-0.09|0.28|||ANCOVA|||||0.28|-0.09|0.3138
71852612|NCT00147745|143219289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.065||0.2042||95.0|-0.05|0.22|||ANCOVA|||||0.22|-0.05|0.2042
71852613|NCT00147745|143219289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.083||0.6855||95.0|-0.2|0.14|||ANCOVA|||||0.14|-0.20|0.6855
71852614|NCT00147745|143219289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.085||0.1727||95.0|-0.05|0.29|||ANCOVA|||||0.29|-0.05|0.1727
71852615|NCT00147745|143219290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.4|STANDARD_ERROR_OF_MEAN|53.17||0.4104||95.0|-152.8|64.1|||ANCOVA|||||64.1|-152.8|0.4104
71852616|NCT00147745|143219290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.1|STANDARD_ERROR_OF_MEAN|69.98||0.8857||95.0|-132.6|152.9|||ANCOVA|||||152.9|-132.6|0.8857
71852617|NCT00147745|143219290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.5|STANDARD_ERROR_OF_MEAN|67.08||0.4226||95.0|-191.3|82.3|||ANCOVA|||||82.3|-191.3|0.4226
71852618|NCT00147745|143219291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.366||0.2286||95.0|-1.2|0.3|||ANCOVA|||||0.30|-1.20|0.2286
71852619|NCT00147745|143219291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.515||0.3184||95.0|-0.53|1.57|||ANCOVA|||||1.57|-0.53|0.3184
71852620|NCT00147745|143219291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0613||95.0|-1.99|0.05|||ANCOVA|||||0.05|-1.99|0.0613
71852621|NCT00147745|143219292|SUPERIORITY_OR_OTHER|||||||0.0362||95.0|||||t-test, 2 sided|||||||0.0362
71852622|NCT00422162|143219307|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||P-value for Change from Baseline. A priori alpha threshold was 0.05 with no adjustment for multiple testing.|ANCOVA|ANCOVA with stratification factors (country and pretreatment for MDD) and MADRS baseline as covariates and treatment regimen as the main factor.||||||0.88
71852623|NCT00422162|143219317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
71852624|NCT00422162|143219317|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.001
71852625|NCT00422162|143219317|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||<0.0001
71902716|NCT05896761|143327032|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.966|1.17||||||||1.17|0.966|
71902717|NCT05896761|143327032|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.07|1.29||||||||1.29|1.07|
71680109|NCT05633992|142877962|SUPERIORITY|A conclusion of superiority of V116 to PPSV23 requires the lower bound of the 2-sided 95% confidence interval of the difference (V116-PPSV23) between the percentage of participants to be \>0 percentage points (one-sided p-value \<0.025).|Difference in Percent|47.0|||<|0.001|TWO_SIDED|95.0|39.5|54.1|||Stratified Miettinen & Nurminen||Estimated difference and confidence interval are based on the Miettinen \& Nurminen method.|Serotype 35B||54.1|39.5|<0.001
71680110|NCT00401544|142877988|SUPERIORITY_OR_OTHER||Percentage of participants|71.0||||||95.0|63.0|80.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||80|63|
71680111|NCT00401544|142877988|SUPERIORITY_OR_OTHER||Percentage of participants|63.0||||||95.0|54.0|72.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||72|54|
71680112|NCT00401544|142877989|SUPERIORITY_OR_OTHER||Percentage of participants|73.0||||||95.0|64.0|81.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||81|64|
71680113|NCT00401544|142877989|SUPERIORITY_OR_OTHER||Percentage of participants|62.0||||||95.0|54.0|71.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||71|54|
71680114|NCT00401544|142877994|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
71820983|NCT01154036|143144145|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-9.3|||<|0.001|TWO_SIDED|95.0|-14.8|-3.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-3.9|-14.8|<0.001
71820984|NCT01154036|143144145|SUPERIORITY_OR_OTHER_LEGACY||Difference in M-estimates|-8.4|||<|0.001|TWO_SIDED|95.0|-12.6|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values||||-4.2|-12.6|<0.001
71820985|NCT01154036|143144146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-3.9||||0.613|TWO_SIDED|95.0|-18.9|11.1|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||11.1|-18.9|0.613
71852626|NCT00422162|143219317|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test||||||0.28
71902718|NCT05896761|143327033|OTHER||Ratio of geometric least square mean|1.35|||||TWO_SIDED|90.0|1.22|1.49||||||||1.49|1.22|
71680115|NCT00401544|142877994|SUPERIORITY_OR_OTHER||Percentage of participants|38.0||||||95.0|29.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|29|
71680116|NCT00401544|142877995|SUPERIORITY_OR_OTHER||Percentage of participants|35.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||44|27|
71680117|NCT00401544|142877995|SUPERIORITY_OR_OTHER||Percentage of participants|39.0||||||95.0|30.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||47|30|
71680118|NCT00401544|142877996|SUPERIORITY_OR_OTHER||Percentage of participants|26.0||||||95.0|15.0|38.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||38|15|
71680119|NCT00401544|142877996|SUPERIORITY_OR_OTHER||Percentage of participants|31.0||||||95.0|19.0|42.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||42|19|
71680120|NCT00401544|142877996|SUPERIORITY_OR_OTHER||Percentage of participants|28.0||||||95.0|17.0|40.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||40|17|
71680121|NCT00401544|142877996|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|14.0|36.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||36|14|
71680122|NCT00401544|142877997|SUPERIORITY_OR_OTHER||Percentage of participants|68.0||||||95.0|59.0|76.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||76|59|
71680123|NCT00401544|142877997|SUPERIORITY_OR_OTHER||Percentage of participants|59.0||||||95.0|50.0|68.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||68|50|
71680124|NCT00401544|142877998|SUPERIORITY_OR_OTHER||Percentage of participants|53.0||||||95.0|44.0|62.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||62|44|
71680125|NCT00401544|142877998|SUPERIORITY_OR_OTHER||Percentage of participants|74.0||||||95.0|66.0|82.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.|||82|66|
71680126|NCT01041976|142878031|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71680127|NCT01041976|142878032|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71680128|NCT00380081|142878033|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71680129|NCT00380081|142878034|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.001
71680130|NCT00380081|142878035|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71680131|NCT00380081|142878036|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71680132|NCT00380081|142878037|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71852627|NCT02342275|143219365|NON_INFERIORITY|Assuming that the atenolol on the propranolol response rate does not fall by greater than 15%, the noninferiority margin was selected to be -15%.|Odds Ratio (OR)|0.15|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis||Treatment Difference=Propranolol vs Atenolol|The sample size required to compare propranolol and atenolol at month 6 was calculated before enrollment. Assuming the ulceration rate in both groups to be 10%, a sample size of180 patients was required for each group to show the noninferiority ofatenolol treatment with a 2-sidedα level of .05 and approximately 90% power||||<0.05
71852628|NCT04908800|143219373|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.88|||||TWO_SIDED|90.0|1.74|2.04|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 10.7."|||2.04|1.74|
71680133|NCT00380081|142878038|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71820986|NCT01154036|143144146|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-1.5||||0.831|TWO_SIDED|95.0|-15.7|12.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||12.6|-15.7|0.831
71902719|NCT05896761|143327033|OTHER||Ratio of geometric least square mean|1.1|||||TWO_SIDED|90.0|0.975|1.24||||||||1.24|0.975|
71680134|NCT00380081|142878039|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.||||<0.001
71680135|NCT00380081|142878040|SUPERIORITY_OR_OTHER||||||<|0.004||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||<0.004
71820987|NCT01154036|143144147|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-13.1||||0.187|TWO_SIDED|95.0|-32.6|6.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||6.4|-32.6|0.187
71820988|NCT01154036|143144147|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares Means|-11.6||||0.153|TWO_SIDED|95.0|-27.7|4.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means||||4.4|-27.7|0.153
71820989|NCT03226457|143144171|OTHER|Details of the power calculation are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739|||||=|0.005||||||(calculated)|ANCOVA|||"Details on the statistical analysis are published in the Circulation, DOI: 10.1161/CIRCULATIONAHA.120.048739~Analyses were performed on the primary and secondary measures comparing empagliflozin versus placebo and assessed by 2-way analysis of covariance correcting for treatment order, baseline value, and any percentage change in furosemide dose at the visit. Data for continuous outcome measures were assessed for normality before analysis."||||= 0.005
71820990|NCT04102540|143144186|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following exposure 2 to the intervention.|Median Difference (Net)|57.39||||0.283|TWO_SIDED|95.0|-48.9|163.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 2.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 2 to the intervention.||163.7|-48.9|0.283
71820991|NCT04102540|143144186|OTHER|In this analysis, our null hypothesis was that the median CD4 count at baseline/exposure 1 was exactly equivalent to the median CD4 count following the exposure 3 to the intervention.|Median Difference (Net)|60.83||||0.1823|TWO_SIDED|95.0|-29.5|151.2||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile regression|Random intercepts for subjects were included in the model.|This is the difference in median CD4 count between baseline/exposure 1 and exposure 3.|Statistical analysis of CD4 count between baseline/exposure 1 and exposure 3 to the intervention.||151.2|-29.5|0.1823
71820992|NCT04102540|143144187|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 2 to the intervention.|Median Difference (Net)|-42.0||||0.7795|TWO_SIDED|95.0|-339.8|255.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression||This is the difference in median viral load between baseline/exposure 1 and exposure 2.|Statistical analysis of viral load between baseline/exposure 1 and exposure 2 to the intervention.||255.8|-339.8|0.7795
71820993|NCT04102540|143144187|OTHER|In this analysis, our null hypothesis was that the median viral load at baseline/exposure 1 was exactly equivalent to the median viral load following exposure 3 to the intervention.|Median Difference (Net)|-63.0||||0.5971|TWO_SIDED|95.0|-296.1|170.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|||Statistical analysis of viral load between baseline/exposure 1 and exposure 3 to the intervention.|This is the difference in median viral load between baseline/exposure 1 and exposure 3.|170.1|-296.1|0.5971
71820994|NCT04102540|143144188|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 2 to the intervention.|Median Difference (Net)|2.12|||<|0.0001|TWO_SIDED|95.0|1.2|3.0||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-Related knowledge scores between baseline/exposure 1 and exposure 2.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 2 to the intervention.||3.0|1.2|<.0001
71820995|NCT04102540|143144188|OTHER|In this analysis, our null hypothesis was that the median HIV-related knowledge score at baseline/exposure 1 was exactly equivalent to the median HIV-related knowledge score following exposure 3 to the intervention.|Median Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.2|2.8||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median HIV-related knowledge score between baseline/exposure 1 and exposure 3.|Statistical analysis of HIV-related knowledge scores between baseline/exposure 1 and exposure 3 to the intervention.||2.8|1.2|<.0001
71852629|NCT04908800|143219374|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.68|||||TWO_SIDED|90.0|1.57|1.79|||||"Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect.~Within-subject coefficient of variation was 9.01."|||1.79|1.57|
71852630|NCT04908800|143219375|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.15|||||TWO_SIDED|90.0|1.09|1.21|||||Data were analyzed using a mixed model which included actual treatment as fixed effect and participant as a random effect. Within-subject coefficient of variation was 7.18.|||1.21|1.09|
71820996|NCT04102540|143144190|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 2 to the intervention.|Median Difference (Net)|0.01||||0.9879|TWO_SIDED|95.0|-0.7|0.7||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 2.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 2 to the intervention.||0.7|-0.7|0.9879
71820997|NCT04102540|143144190|OTHER|In this analysis, our null hypothesis was that the median self-efficacy to manage HIV scale score at baseline/exposure 1 was exactly equivalent to the median self-efficacy to manage HIV scale score following exposure 3 to the intervention.|Median Difference (Net)|0.57||||0.155|TWO_SIDED|95.0|-0.2|1.4||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median self-efficacy to manage HIV scale scores between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||1.4|-0.2|0.1550
71852631|NCT04908800|143219380|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.971|||||TWO_SIDED|95.0|0.882|1.06|||||Between-subject geometric coefficient of variation was 26.1. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.882|
71852632|NCT04908800|143219380|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.01|||||TWO_SIDED|95.0|0.926|1.11|||||Geometric least squares mean was 600 (fasted) and 607 (fed). Within-subject coefficient of variation was 6.01. Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect.|Food Effect Assessment||1.11|0.926|
71852633|NCT04908800|143219380|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.06|||||TWO_SIDED|95.0|0.701|1.59|||||Geometric least squares mean was 600 (fasted male) and 634 (fasted female). Between subject coefficient of variation was 32.7. Data were analyzed using an ANOVA model which included actual treatment as a factor.|Sex Effect Assessment||1.59|0.701|
71902720|NCT05896761|143327034|OTHER||Ratio of geometric least square mean|1.26|||||TWO_SIDED|90.0|1.12|1.4||||||||1.40|1.12|
71902721|NCT05896761|143327034|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.09|1.28||||||||1.28|1.09|
71902722|NCT05896761|143327035|OTHER||Ratio of geometric least square mean|1.21|||||TWO_SIDED|90.0|1.13|1.3||||||||1.30|1.13|
71902723|NCT05896761|143327035|OTHER||Ratio of geometric least square mean|1.09|||||TWO_SIDED|90.0|1.0|1.2||||||||1.20|1.00|
71902724|NCT05896761|143327036|OTHER||Ratio of geometric least square mean|1.15|||||TWO_SIDED|90.0|1.07|1.23||||||||1.23|1.07|
71902725|NCT05896761|143327036|OTHER||Ratio of geometric least square mean|1.29|||||TWO_SIDED|90.0|1.2|1.38||||||||1.38|1.20|
71902726|NCT05896761|143327037|OTHER||Ratio of geometric least square mean|1.16|||||TWO_SIDED|90.0|1.08|1.25||||||||1.25|1.08|
71902727|NCT05896761|143327037|OTHER||Ratio of geometric least square mean|0.983|||||TWO_SIDED|90.0|0.89|1.09||||||||1.09|0.890|
71902728|NCT05896761|143327038|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.991|1.13||||||||1.13|0.991|
71902729|NCT05896761|143327038|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.974|1.12||||||||1.12|0.974|
71902730|NCT05896761|143327039|OTHER||Ratio of geometric least square mean|1.18|||||TWO_SIDED|90.0|1.11|1.25||||||||1.25|1.11|
71902731|NCT05896761|143327039|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|0.989|1.14||||||||1.14|0.989|
71902732|NCT05896761|143327040|OTHER||Ratio of geometric least square mean|1.08|||||TWO_SIDED|90.0|1.03|1.12||||||||1.12|1.03|
71902733|NCT05896761|143327040|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.997|1.08||||||||1.08|0.997|
71680136|NCT00380081|142878041|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Treatment effect|Cochran-Mantel-Haenszel|||||||0.012
71902734|NCT05896761|143327041|OTHER||Ratio of geometric least square mean|1.13|||||TWO_SIDED|90.0|1.08|1.19||||||||1.19|1.08|
71902735|NCT05896761|143327041|OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|0.97|1.11||||||||1.11|0.97|
71902736|NCT05896761|143327042|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.02|1.11||||||||1.11|1.02|
71902737|NCT05896761|143327042|OTHER||Ratio of geometric least square mean|1.06|||||TWO_SIDED|90.0|1.01|1.11||||||||1.11|1.01|
71902738|NCT03552549|143327072|OTHER||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.28|1.77|||||Hazard ratio presented as PEG-Intron/INTRON A; HR \<1 indicates treatment effect in favor of PEG-Intron.|||1.77|0.28|
71902739|NCT05515601|143327099|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|0.986|||||TWO_SIDED|90.0|0.929|1.05||||||||1.05|0.929|
71902740|NCT05515601|143327100|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability.|Ratio of Geometric least squares mean|1.01|||||TWO_SIDED|90.0|0.948|1.08||||||||1.08|0.948|
71902741|NCT05515601|143327101|OTHER|A linear fixed-effects model is used to estimate the relative bioavailability|Ratio of Geometric least squares mean|1.02|||||TWO_SIDED|90.0|0.96|1.09||||||||1.09|0.960|
71902742|NCT00777491|143327102|OTHER|There was no formal comparison of the two treatment arms.||||||||||||||||The confidence interval of the rate was calculated by Clopper-Pearson's exact binomial confidence intervals methods with one-sided type I error of 0.1. The study required 32 analyzable patients in each arm, which would warrant a 10% chance of observing a percentage of patients without distant metastasis by 3 years of less than 75% if the true rate was 86%. With the actual number of evaluable patients, the study instead warrants a 13-14% chance.|If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen.|||
71902743|NCT00777491|143327105|SUPERIORITY||Odds Ratio (OR)|0.493||||0.3|TWO_SIDED|95.0|0.129|1.881||Two-sided significance level of 0.05|Regression, Logistic|Univariate analysis|Reference arm = 5-FU and Cisplatin + BID Irradiation|||1.881|0.129|0.30
71820998|NCT04102540|143144191|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.17||||0.819|TWO_SIDED|95.0|0.3|4.52||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 2 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||4.52|0.30|0.8190
71820999|NCT04102540|143144191|OTHER|In this model, the null hypothesis was that the odds of being non-adherent at baseline/exposure 1 were exactly equal to the odds of being non-adherent at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|0.3||||0.1332|TWO_SIDED|95.0|0.07|1.43||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|In this model, the odds ratio estimate is for the odds of being non-adherent at exposure 3 relative to the odds of being non-adherent at baseline/exposure 1.|"For analysis, we dichotomized participants adherence as adherent or non-adherent."||1.43|0.07|0.1332
71821000|NCT04102540|143144192|OTHER|In this model, the null hypothesis was that the odds of good health at baseline/exposure 1 were exactly equal to the odds of good health at exposure 2 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.77||||0.316|TWO_SIDED|95.0|0.57|5.46||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 2 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||5.46|0.57|0.3160
71821001|NCT04102540|143144192|OTHER|In this model, the null hypothesis was that the odds of having good health at baseline/exposure 1 were exactly equal to the odds of having good health at exposure 3 giving an odds ratio of one for the null hypothesis.|Odds Ratio (OR)|1.12||||0.8609|TWO_SIDED|95.0|0.32|3.93||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Regression, Logistic|This model included random effects for subjects.|This is the estimated odds ratio of having good health at exposure 3 relative to baseline/exposure 1.|"For analysis, we dichotomized participants' responses into the following categories: good vs bad health, where good included participant responses: excellent, very good, good, and bad included the participant responses: more or less and bad."||3.93|0.32|0.8609
71821002|NCT04102540|143144193|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 2 to the intervention.|Median Difference (Net)|9.13||||0.0572|TWO_SIDED|95.0|-0.3|18.6||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 2.|Statistical analysis of current health status between baseline/exposure 1 and exposure 2 to the intervention.||18.6|-0.3|0.0572
71821003|NCT04102540|143144193|OTHER|In this analysis, our null hypothesis was that the median current health status at baseline/exposure 1 was exactly equivalent to the median current health status following exposure 3 to the intervention.|Median Difference (Net)|13.1||||0.0332|TWO_SIDED|95.0|1.1|25.1||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05.|Quantile Regression|Random intercepts for subjects were included in the model.|This is the difference in median current health status between baseline/exposure 1 and exposure 3.|Statistical analysis of self-efficacy to manage HIV scale score between baseline/exposure 1 and exposure 3 to the intervention.||25.1|1.1|0.0332
71821004|NCT01009047|143144206|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.83||0.935|TWO_SIDED|95.0|-3.46|3.76||Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.76|-3.46|0.935
71821005|NCT01009047|143144207|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|2.2||0.877|TWO_SIDED|95.0|-4.68|4.0||Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||4.00|-4.68|0.877
71821006|NCT01009047|143144208|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.54||0.341|TWO_SIDED|95.0|-0.55|1.59||Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.59|-0.55|0.341
71821007|NCT01009047|143144208|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.723|TWO_SIDED|95.0|-1.06|1.53||Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||1.53|-1.06|0.723
71821008|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.351||||||Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.351
71821009|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.691||||||Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.691
71821010|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.965||||||Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.965
71821011|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.766||||||Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.766
71902744|NCT00777491|143327106|SUPERIORITY||Odds Ratio (OR)|1.5||||0.75|TWO_SIDED|95.0|0.426|5.277||Two-sided significance level of 0.05|Regression, Logistic|Univariable analysis|Reference arm = 5-FU and Cisplatin + BID irradiation|||5.277|0.426|0.75
71902745|NCT04160468|143327110|SUPERIORITY||Risk Difference (RD)|-10.6||||0.392|TWO_SIDED|95.0|-33.6|12.4|||Fisher Exact|||||12.4|-33.6|0.392
71680137|NCT00380081|142878042|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71821012|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.984||||||Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.984
71821013|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.985||||||Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||||0.985
71821014|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.803||||||Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.803
71821015|NCT01009047|143144209|SUPERIORITY_OR_OTHER|||||||0.745||||||Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA|||||||0.745
71821016|NCT01009047|143144211|SUPERIORITY_OR_OTHER|||||||0.296||||||Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.|Cochran-Mantel-Haenszel|||||||0.296
71821017|NCT01009047|143144212|SUPERIORITY_OR_OTHER|||||||0.843||||||Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.843
71821018|NCT01009047|143144212|SUPERIORITY_OR_OTHER|||||||0.914||||||Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA|||||||0.914
71821019|NCT01009047|143144213|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.27||0.895|TWO_SIDED|95.0|-2.34|2.67||Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||2.67|-2.34|0.895
71821020|NCT01009047|143144213|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|1.66||0.705|TWO_SIDED|95.0|-2.64|3.89||Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA|||||3.89|-2.64|0.705
71821021|NCT01009047|143144214|SUPERIORITY_OR_OTHER|||||||0.119||||||Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.119
71821022|NCT01009047|143144214|SUPERIORITY_OR_OTHER|||||||0.444||||||Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel|||||||0.444
71821023|NCT03875911|143144215|EQUIVALENCE|ANOVA was used to analyze equivalence between arms||||||0.52|||||||ANOVA|||||||0.52
71821024|NCT03875911|143144216|EQUIVALENCE|Equivalence calculated using ANOVA||||||0.01|||||||ANOVA|||||||0.01
71821025|NCT03875911|143144217|EQUIVALENCE|Equivalence was assessed using ANOVA||||||0.25|||||||ANOVA|||||||0.25
71821026|NCT03875911|143144218|EQUIVALENCE|Equivalence determined by ANOVA||||||0.93|||||||ANOVA|||||||0.93
71902746|NCT01187901|143327112|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71821027|NCT03875911|143144219|EQUIVALENCE|Equivalence determined by ANOVA||||||0.83|||||||ANOVA|||||||0.83
71821028|NCT03875911|143144220|EQUIVALENCE|Equivalence was determined using ANOVA||||||0.54|||||||ANOVA|||||||0.54
71821029|NCT02571439|143144226|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71821030|NCT02571439|143144227|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71821031|NCT02571439|143144228|OTHER|||||||0.61|||||||Kruskal-Wallis|||||||0.61
71821032|NCT02571439|143144229|OTHER|||||||0.46|||||||Kruskal-Wallis|||||||0.46
71821033|NCT02571439|143144230|OTHER|||||||0.33|||||||Kruskal-Wallis|||||||0.33
71821034|NCT02571439|143144231|OTHER|||||||0.13|||||||Kruskal-Wallis|||||||0.13
71821035|NCT02571439|143144232|OTHER|||||||0.17|||||||Kruskal-Wallis|||||||0.17
71821036|NCT02571439|143144233|OTHER|||||||0.87|||||||Kruskal-Wallis|||||||0.87
71821037|NCT02571439|143144234|OTHER|||||||0.27|||||||Chi-squared|||||||0.27
71821038|NCT02571439|143144235|OTHER|||||||0.91|||||||Kruskal-Wallis|||||||0.91
71821039|NCT01058863|143144236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.88|1.42||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.42|0.88|<0.0001
71821040|NCT01058863|143144236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.7|1.24||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.24|0.70|<0.0001
71821041|NCT01058863|143144236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.08|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.81|1.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..||1.35|0.81|<0.0001
71902747|NCT01187901|143327113|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71902748|NCT01187901|143327114|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71902749|NCT01187901|143327115|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71852634|NCT04908800|143219381|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.977|||||TWO_SIDED|95.0|0.891|1.06|||||Between-subject geometric coefficient of variation was 25.4. Data were analyzed using a power model.|Dose Proportionality Assessment||1.06|0.891|
71852635|NCT04908800|143219381|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.0|||||TWO_SIDED|95.0|0.905|1.12|||||"Geometric least squares mean was 575 (fasted) and 578 (fed). Within-subject coefficient of variation was 7.05.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.12|0.905|
71852636|NCT04908800|143219381|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.04|||||TWO_SIDED|95.0|0.707|1.54|||||"Geometric least squares mean was 575 (fasted male) and 600 (fasted female). Between subject coefficient of variation was 31.1.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.54|0.707|
71852637|NCT04908800|143219382|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|0.989|||||TWO_SIDED|95.0|0.909|1.07|||||Between-subject geometric coefficient of variation was 23.0. Data were analyzed using a power model.|Dose Proportionality Assessment||1.07|0.909|
71852638|NCT04908800|143219382|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|0.948|||||TWO_SIDED|95.0|0.824|1.09|||||"Geometric least squares mean was 31.6 (fasted) and 30.0 (fed). Within-subject coefficient of variation was 9.44.~Data were analyzed using mixed model which included actual treatment as fixed effect and participant as a random effect."|Food Effect Assessment||1.09|0.824|
71852639|NCT04908800|143219382|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Ratio of geometric least squares mean|1.23|||||TWO_SIDED|95.0|0.928|1.62|||||"Geometric least squares mean was 31.6 (fasted male) and 38.8 (fasted female). Between subject coefficient of variation was 22.0.~Data were analyzed using an ANOVA model which included actual treatment as a factor."|Sex Effect Assessment||1.62|0.928|
71852640|NCT04908800|143219387|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.11|||||TWO_SIDED|95.0|0.966|1.26|||||Between-subject geometric coefficient of variation was 26.9. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.26|0.966|
71902750|NCT01187901|143327116|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71902751|NCT01187901|143327117|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71902752|NCT00088634|143327130|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
71902753|NCT00088634|143327131|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
71902754|NCT00088634|143327132|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
71821042|NCT01058863|143144236|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.88|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.61|1.15||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||1.15|0.61|<0.0001
71821043|NCT01058863|143144237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.47|STANDARD_ERROR_OF_MEAN|3.69|<|0.0001|TWO_SIDED|95.0|26.21|40.74||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.74|26.21|<0.0001
71852641|NCT04908800|143219389|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.12|||||TWO_SIDED|95.0|0.945|1.29|||||Between-subject geometric coefficient of variation was 32.1. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.29|0.945|
71902755|NCT00088634|143327133|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.||||<0.05
71902756|NCT00540436|143327134|SUPERIORITY_OR_OTHER||Mean change|33.49||||||95.0|15.231|51.744||||||||51.744|15.231|
71902757|NCT00540436|143327135|SUPERIORITY_OR_OTHER||Mean change|46.82||||||95.0|24.566|69.076||||||||69.076|24.566|
71821044|NCT01058863|143144237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.73|STANDARD_ERROR_OF_MEAN|3.686|<|0.001|TWO_SIDED|95.0|20.47|34.99||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||34.99|20.47|<0.001
71821045|NCT01058863|143144237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.1|STANDARD_ERROR_OF_MEAN|3.686|<|0.0001|TWO_SIDED|95.0|25.84|40.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||40.35|25.84|<0.0001
71821046|NCT01058863|143144237|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.61|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|18.36|32.85||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.||32.85|18.36|<0.0001
71821047|NCT04230980|143144256|SUPERIORITY||Mean Difference (Final Values)|-1.13||||0.01|TWO_SIDED|95.0|-2.02|-0.24|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean NRS-11 score at post-operative day 7 (compared between the two arms).||-0.24|-2.02|0.01
71821048|NCT04230980|143144257|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.19|TWO_SIDED|95.0|-0.13|0.03|||t-test, 2 sided||Direction of mean difference is Gabapentin arm minus placebo arm.|Mean number of opioid tablets taken at post-operative day 7 (compared between the two arms).||0.03|-0.13|0.19
71821049|NCT01767129|143144295|SUPERIORITY||Mean Difference (Final Values)|-83.4||||0.1907|TWO_SIDED|95.0|-215.02|48.23|||ANOVA|The standard analysis of variance (ANOVA) model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The least squares (LS) mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||48.23|-215.02|0.1907
71821050|NCT01767129|143144296|SUPERIORITY||Median Difference (Final Values)|-18.9||||0.388|TWO_SIDED|95.0|-65.28|27.42|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||27.42|-65.28|0.3880
71821051|NCT01767129|143144297|SUPERIORITY||Mean Difference (Final Values)|171.9||||0.7574|TWO_SIDED|95.0|-1022.79|1366.64|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||1366.64|-1022.79|0.7574
71821052|NCT01767129|143144298|SUPERIORITY||Mean Difference (Final Values)|48.8||||0.4203|TWO_SIDED|95.0|-80.63|178.3|||ANOVA|The standard ANOVA model for a 2-period crossover trial was used. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||178.30|-80.63|0.4203
71821053|NCT01767129|143144299|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.1067|TWO_SIDED|95.0|-2.41|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part I||0.27|-2.41|0.1067
71821054|NCT01767129|143144299|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.865|TWO_SIDED|95.0|-2.64|3.09|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part II||3.09|-2.64|0.8650
71821055|NCT01767129|143144299|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0745|TWO_SIDED|95.0|-4.94|0.27|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part IV||0.27|-4.94|0.0745
71821056|NCT01767129|143144300|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.0625|TWO_SIDED|95.0|-8.1|0.24|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 1||0.24|-8.10|0.0625
71821057|NCT01767129|143144300|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.2474|TWO_SIDED|95.0|-3.74|1.07|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Part 2||1.07|-3.74|0.2474
71680138|NCT00380081|142878043|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Treatment effect|ANCOVA|||||||<0.001
71902758|NCT03255291|143327144|SUPERIORITY|A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0288|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition||||0.0288
71902759|NCT03255291|143327144|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.3329|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.||||0.3329
71902760|NCT03255291|143327144|SUPERIORITY|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0215|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior||||0.0215
71902761|NCT03255291|143327145|SUPERIORITY|||||||0.0333||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||-This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons.||||0.0333
71902762|NCT03255291|143327146|SUPERIORITY|||||||0.4946||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.4946
71902763|NCT03255291|143327147|SUPERIORITY|||||||0.1397|||||||ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design \& only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.||||0.1397
71902764|NCT03255291|143327148|SUPERIORITY|||||||0.007||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.0070
71680139|NCT00380081|142878044|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||Treatment effect|ANCOVA|||||||0.790
71821058|NCT01767129|143144301|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9764|TWO_SIDED|95.0|-3.1|3.01|||ANOVA|Change from Day 1 values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||3.01|-3.10|0.9764
71821059|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.6359|TWO_SIDED|95.0|-9.94|6.36|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Mobility||6.36|-9.94|0.6359
71821060|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-8.5||||0.0167|TWO_SIDED|95.0|-15.2|-1.87|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Activities of Daily Living||-1.87|-15.20|0.0167
71821061|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-7.5||||0.0959|TWO_SIDED|95.0|-16.54|1.56|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Emotional Well Being||1.56|-16.54|0.0959
71821062|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.5108|TWO_SIDED|95.0|-16.72|8.83|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Stigma||8.83|-16.72|0.5108
71821063|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.0806|TWO_SIDED|95.0|-21.06|1.42|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Social support||1.42|-21.06|0.0806
71821064|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-4.3||||0.4205|TWO_SIDED|95.0|-15.66|7.03|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Cognitive impairment (Cognitions)||7.03|-15.66|0.4205
71821065|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-6.1||||0.1065|TWO_SIDED|95.0|-13.63|1.53|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Communication||1.53|-13.63|0.1065
71821066|NCT01767129|143144302|SUPERIORITY||Mean Difference (Final Values)|-5.2||||0.4456|TWO_SIDED|95.0|-19.51|9.19|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Bodily discomfort||9.19|-19.51|0.4456
71821067|NCT01767129|143144303|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0233|TWO_SIDED|95.0|-11.72|-1.07|||ANOVA|Change from Baseline values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||-1.07|-11.72|0.0233
71902765|NCT03255291|143327149|SUPERIORITY|||||||0.8793||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.||||0.8793
71902766|NCT03255291|143327150|SUPERIORITY|||||||0.4673||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.4673
71902767|NCT03255291|143327151|SUPERIORITY|||||||0.1916||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1916
71902768|NCT03255291|143327152|SUPERIORITY|||||||0.8661||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.8661
71821068|NCT01767129|143144304|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.193|TWO_SIDED|95.0|-1.39|0.31|||ANOVA|Change from Screening values were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|||0.31|-1.39|0.1930
71821069|NCT01767129|143144305|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0511|TWO_SIDED|95.0|-2.17|0.01|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Dyskinesia||0.01|-2.17|0.0511
71821070|NCT01767129|143144305|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7745|TWO_SIDED|95.0|-0.7|0.91|||ANOVA|Change were compared using ANOVA for a 2-period crossover trial. Factors in the model were participant, treatment, and period.|The LS mean difference was calculated as the AVP-923-45 LS mean minus the placebo LS mean.|Other symptoms||0.91|-0.70|0.7745
71821071|NCT03389893|143144306|SUPERIORITY||Geometric Mean Ratio|0.033|||<|0.001|TWO_SIDED|95.0|0.008|0.131|||ANCOVA||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator.|||0.131|0.008|<0.001
71821072|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.28||||0.019|TWO_SIDED|95.0|0.09|0.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||0.80|0.09|0.019
71821073|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||1.51|0.09|0.165
71821074|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.08|||<|0.001|TWO_SIDED|95.0|0.02|0.27|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||0.27|0.02|<0.001
71821075|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.07|||<|0.001|TWO_SIDED|95.0|0.02|0.25|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||0.25|0.02|<0.001
71821076|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.16||||0.004|TWO_SIDED|95.0|0.05|0.55|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||0.55|0.05|0.004
71821077|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.38||||0.216|TWO_SIDED|95.0|0.08|1.8|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||1.80|0.08|0.216
71821078|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.24||||0.071|TWO_SIDED|95.0|0.05|1.13|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||1.13|0.05|0.071
71821079|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.34||||0.022|TWO_SIDED|95.0|0.13|0.85|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.85|0.13|0.022
71821080|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.76|0.08|0.015
71821081|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.04|0.41|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||0.41|0.04|<0.001
71821082|NCT03389893|143144307|SUPERIORITY||Geometric Mean Ratio|0.16||||0.006|TWO_SIDED|95.0|0.04|0.58|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||0.58|0.04|0.006
71821083|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.8||||0.724|TWO_SIDED|95.0|0.23|2.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 3||2.82|0.23|0.724
71821084|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.27||||0.033|TWO_SIDED|95.0|0.08|0.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 7||0.89|0.08|0.033
71821085|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.36||||0.073|TWO_SIDED|95.0|0.12|1.1|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 14||1.10|0.12|0.073
71821086|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.73||||0.579|TWO_SIDED|95.0|0.23|2.29|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 21||2.29|0.23|0.579
71821087|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.17||||0.003|TWO_SIDED|95.0|0.05|0.53|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 28||0.53|0.05|0.003
71821088|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.52||||0.297|TWO_SIDED|95.0|0.15|1.81|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 42||1.81|0.15|0.297
71821089|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.48||||0.326|TWO_SIDED|95.0|0.11|2.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 77||2.12|0.11|0.326
71821090|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.52||||0.401|TWO_SIDED|95.0|0.11|2.42|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is numerator and Placebo+Open Label Extension and Follow-Up arm is denominator|Day 112||2.42|0.11|0.401
71821091|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.81||||0.705|TWO_SIDED|95.0|0.28|2.4|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||2.40|0.28|0.705
71821092|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.72||||0.538|TWO_SIDED|95.0|0.25|2.08|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.08|0.25|0.538
71821093|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.92||||0.892|TWO_SIDED|95.0|0.25|3.34|||Mixed Models Analysis||Day 77 is numerator and Day 42 is denominator|Day 77 / Day 42||3.34|0.25|0.892
71821094|NCT03389893|143144308|SUPERIORITY||Geometric Mean Ratio|0.74||||0.624|TWO_SIDED|95.0|0.21|2.56|||Mixed Models Analysis||Day 112 is numerator and Day 42 is denominator|Day 112 / Day 42||2.56|0.21|0.624
71821095|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-9.53||||0.019|TWO_SIDED|95.0|-17.44|-1.63|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference.)|Day 3, Lesional||-1.63|-17.44|0.019
71821096|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.837|TWO_SIDED|95.0|-11.47|9.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Lesional||9.32|-11.47|0.837
71821097|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.9|TWO_SIDED|95.0|-6.98|7.92|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Lesional||7.92|-6.98|0.900
71821098|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-5.97||||0.13|TWO_SIDED|95.0|-13.76|1.82|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Lesional||1.82|-13.76|0.130
71821099|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-7.1||||0.069|TWO_SIDED|95.0|-14.76|0.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Lesional||0.56|-14.76|0.069
71821100|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-7.99||||0.032|TWO_SIDED|95.0|-15.25|-0.73|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Lesional||-0.73|-15.25|0.032
71821101|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.803|TWO_SIDED|95.0|-9.37|7.28|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||7.28|-9.37|0.803
71821102|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.972|TWO_SIDED|95.0|-9.02|9.34|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Lesional||9.34|-9.02|0.972
71821103|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.933|TWO_SIDED|95.0|-6.66|6.12|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||6.12|-6.66|0.933
71821104|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-1.82||||0.563|TWO_SIDED|95.0|-8.1|4.45|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||4.45|-8.10|0.563
71902769|NCT03255291|143327153|SUPERIORITY|||||||0.0711||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0711
71852642|NCT04908800|143219390|EQUIVALENCE|Study was not powered and confidence intervals were assessed for containing unity (1) within them.|Slope|1.1|||||TWO_SIDED|95.0|0.971|1.23|||||Between-subject geometric of coefficient variation was 23.2. Data were analyzed using a power model.|"Dose Proportionality Assessment. KRP-A218 assessed across the following dose levels: 2 mg, 4 mg, 8 mg, and 11 mg.~Dose proportionality results for Part B are only for the Day 14 profile (not Day 1)."||1.23|0.971|
71852643|NCT02267746|143219399|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.93|||||TWO_SIDED|90.0|0.86|1.02|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.02|0.86|
71852644|NCT02267746|143219400|EQUIVALENCE|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller's method.|Mean Difference (Net)|0.96|||||TWO_SIDED|90.0|0.89|1.04|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval \[0.80, 1.25\] for the PP population.|||1.04|0.89|
71852645|NCT02267746|143219401|EQUIVALENCE|Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for PP population.|Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.15|0.004|||||Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval \[-0.20, +0.20\] for the PP population.|Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.||0.004|-0.150|
71852646|NCT02268526|143219434|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.891|||||TWO_SIDED|90.0|0.606|1.305||||||||1.305|0.606|
71852647|NCT02268526|143219434|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.941|||||TWO_SIDED|90.0|0.639|1.377||||||||1.377|0.639|
71852648|NCT00763919|143219448|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
71852649|NCT00763919|143219449|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.01
71852650|NCT00763919|143219450|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||<.001
71852651|NCT00763919|143219451|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<.001
71852652|NCT00763919|143219452|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
71852653|NCT00763919|143219453|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.042
71852654|NCT00763919|143219454|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.044
71852655|NCT00763919|143219455|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
71852656|NCT00763919|143219456|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.||||.001
71852657|NCT00763919|143219457|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
71852658|NCT00763919|143219458|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.001
71852659|NCT00763919|143219459|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.827
71852660|NCT00763919|143219460|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.||||.002
71852661|NCT00763919|143219461|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.246
71852662|NCT00763919|143219462|SUPERIORITY_OR_OTHER|||||||0.101||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.101
71852663|NCT00763919|143219463|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.003
71852664|NCT00763919|143219464|SUPERIORITY_OR_OTHER|||||||0.096||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.096
71821105|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-7.08||||0.075|TWO_SIDED|95.0|-14.88|0.73|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Lesional||0.73|-14.88|0.075
71821106|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-9.84||||0.01|TWO_SIDED|95.0|-17.19|-2.48|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Lesional||-2.48|-17.19|0.010
71821107|NCT03389893|143144309|SUPERIORITY||Median Difference (Final Values)|0.69||||0.805|TWO_SIDED|95.0|-4.86|6.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 3, Non-lesional||6.23|-4.86|0.805
71821108|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|2.36||||0.329|TWO_SIDED|95.0|-2.44|7.15|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7, Non-lesional||7.15|-2.44|0.329
71821109|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.97|TWO_SIDED|95.0|-5.39|5.6|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14, Non-lesional||5.60|-5.39|0.970
71821110|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-3.31||||0.18|TWO_SIDED|95.0|-8.18|1.56|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21, Non-lesional||1.56|-8.18|0.180
71821111|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.342|TWO_SIDED|95.0|-5.45|1.94|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28, Non-lesional||1.94|-5.45|0.342
71821112|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-2.17||||0.234|TWO_SIDED|95.0|-5.81|1.47|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42, Non-lesional||1.47|-5.81|0.234
71821113|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.316|TWO_SIDED|95.0|-6.27|2.07|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Non-lesional||2.07|-6.27|0.316
71821114|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-1.89||||0.276|TWO_SIDED|95.0|-5.37|1.59|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112, Non-lesional||1.59|-5.37|0.276
71821115|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-1.56||||0.237|TWO_SIDED|95.0|-4.19|1.06|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||1.06|-4.19|0.237
71821116|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-3.03||||0.01|TWO_SIDED|95.0|-5.3|-0.77|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||-0.77|-5.30|0.010
71821117|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-0.46||||0.77|TWO_SIDED|95.0|-3.57|2.65|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42, Non-lesional||2.65|-3.57|0.770
71821118|NCT03389893|143144309|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.117|TWO_SIDED|95.0|-4.84|0.56|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42, Non-lesional||0.56|-4.84|0.117
71821119|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|85.05||||0.085|TWO_SIDED|95.0|-12.02|182.12|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||182.12|-12.02|0.085
71821120|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-21.91||||0.733|TWO_SIDED|95.0|-149.13|105.32|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||105.32|-149.13|0.733
71821121|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-82.5||||0.129|TWO_SIDED|95.0|-189.6|24.61|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||24.61|-189.60|0.129
71821122|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-92.11||||0.057|TWO_SIDED|95.0|-187.11|2.89|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||2.89|-187.11|0.057
71821123|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-48.76||||0.242|TWO_SIDED|95.0|-131.52|34.0|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||34.00|-131.52|0.242
71821124|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-54.37||||0.262|TWO_SIDED|95.0|-150.24|41.49|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||41.49|-150.24|0.262
71821125|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-22.97||||0.546|TWO_SIDED|95.0|-99.79|53.86|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||53.86|-99.79|0.546
71680140|NCT00380081|142878045|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||Treatment effect|ANCOVA|||||||0.083
71680141|NCT00380081|142878046|SUPERIORITY_OR_OTHER|||||||0.072||95.0||||Treatment effect|ANCOVA|||||||0.072
71821126|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-21.8||||0.503|TWO_SIDED|95.0|-86.34|42.75|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||42.75|-86.34|0.503
71821127|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-64.0||||0.034|TWO_SIDED|95.0|-123.01|-4.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-4.98|-123.01|0.034
71821128|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-10.29||||0.789|TWO_SIDED|95.0|-86.63|66.04|||Mixed Models Analysis||Day 77 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 77 / Day 42||66.04|-86.63|0.789
71821129|NCT03389893|143144310|SUPERIORITY||Mean Difference (Final Values)|-83.9||||0.014|TWO_SIDED|95.0|-149.82|-17.98|||Mixed Models Analysis||Day 112 is minuend and Day 42 is subtrahend. (Minuend - subtrahend=difference).|Day 112 / Day 42||-17.98|-149.82|0.014
71821130|NCT03389893|143144311|SUPERIORITY||Slope|-0.07||||0.86|TWO_SIDED|95.0|-0.92|0.77|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 7||0.77|-0.92|0.860
71852665|NCT00763919|143219465|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.072
71852666|NCT00763919|143219466|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<.001
71852667|NCT00763919|143219467|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.078
71852668|NCT00763919|143219468|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||.002
71852669|NCT00763919|143219469|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.562
71852670|NCT00763919|143219470|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||.12
71852671|NCT03305458|143219477|SUPERIORITY||||||||||||||||||To determine if child and caregiver engagement is affected by overall SPARK use, a 2-level MLM (level-1 child, level-2 provider) will be used. Engagement scores will be calculated per child and caregiver participant. An aggregate engagement score will determine if there are differences across conditions (SPARK + TF CBT vs standard TF-CBT) while accounting for the nesting providers.|||
71852672|NCT03305458|143219478|SUPERIORITY||||||||||||||||||To determine if provider fidelity is affected by overall SPARK use, a 2-level MLM (level-1 child; level-2 provider) will be used. Fidelity will be measured by the TF-CBT TPOCS-S. Providers' overall use of the toolkit will be calculated per child participant and averaged across toolkit content. Fidelity scores will be calculated per child participant such that each provider will have three ratings. An aggregate fidelity score will determine if there are differences across conditions (SPARK + TF-CBT vs. standard TF-CBT) while accounting for the nesting of providers.|||
71852673|NCT03305458|143219479|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-to provider.|||
71852674|NCT03305458|143219480|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852675|NCT03305458|143219481|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852676|NCT03305458|143219482|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852677|NCT03305458|143219483|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852678|NCT03305458|143219484|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852679|NCT03305458|143219485|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
71852680|NCT03305458|143219486|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
71852681|NCT03305458|143219487|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
71852682|NCT03305458|143219488|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852683|NCT03305458|143219489|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852684|NCT03305458|143219490|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71821131|NCT03389893|143144311|SUPERIORITY||Slope|-0.22||||0.488|TWO_SIDED|95.0|-0.85|0.41|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 14||0.41|-0.85|0.488
71821132|NCT03389893|143144311|SUPERIORITY||Slope|-0.55||||0.144|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 21||0.20|-1.30|0.144
71902770|NCT03255291|143327154|SUPERIORITY|||||||0.0365||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.0365
71902771|NCT03255291|143327155|SUPERIORITY|||||||0.1511||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.||||0.1511
71902772|NCT04019093|143327156|SUPERIORITY|||||||0.99|||||||ANOVA|F(1,46) = .001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the beverage condition X group interaction.||||.99
71902773|NCT04019093|143327156|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,46)=12.55||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
71902774|NCT04019093|143327156|SUPERIORITY|||||||0.015|||||||ANOVA|F(1,46)=6.32||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) mixed general linear model on pressure threshold. Here we report the results of the analysis of the main effect of group.||||.015
71902775|NCT04019093|143327157|SUPERIORITY|||||||0.76|||||||ANOVA|F(2,82)=.20||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X group interaction.||||.76
71902776|NCT04019093|143327157|SUPERIORITY|||||||0.52|||||||ANCOVA|F(2,82)=.66||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the pressure level X beverage condition interaction.||||.52
71902777|NCT04019093|143327157|SUPERIORITY|||||||0.04|||||||ANOVA|F(1,41)=4.53, p=.04||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of beverage condition.||||.04
71902778|NCT04019093|143327157|SUPERIORITY|||||||0.017|||||||ANOVA|F(1,41)=6.24||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of group.||||.017
71902779|NCT04019093|143327157|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(2,82)=48.41||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain intensity. Here we report the results of the analysis of the main effect of pressure level.||||<.0001
71902780|NCT04019093|143327158|SUPERIORITY|||||||0.5|||||||ANOVA|F (2, 82) = 0.69||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level X group interaction.||||.50
71821133|NCT03389893|143144311|SUPERIORITY||Slope|-0.35||||0.279|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 28||0.30|-1.00|0.279
71821134|NCT03389893|143144311|SUPERIORITY||Slope|-0.29||||0.461|TWO_SIDED|95.0|-1.09|0.5|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 42||0.50|-1.09|0.461
71821135|NCT03389893|143144311|SUPERIORITY||Slope|-0.27||||0.345|TWO_SIDED|95.0|-0.84|0.3|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 77, Lesional||0.30|-0.84|0.345
71821136|NCT03389893|143144311|SUPERIORITY||Slope|-0.27||||0.275|TWO_SIDED|95.0|-0.77|0.23|||Mixed Models Analysis||Dupilumab+Open Label Extension and Follow-Up arm is minuend and Placebo+Open Label Extension and Follow-Up arm is subtrahend. (Minuend - subtrahend=difference).|Day 112||0.23|-0.77|0.275
71902781|NCT04019093|143327158|SUPERIORITY|||||||0.21|||||||ANOVA|F(2,82)=1.58||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X pressure level interaction.||||.21
71902782|NCT04019093|143327158|SUPERIORITY|||||||0.053|||||||ANOVA|F(2,82)=3.06||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the pressure level X group interaction.||||.053
71680142|NCT00380081|142878046|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Period effect|ANCOVA|||||||<0.001
71680143|NCT00380081|142878047|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||Treatment effect|ANCOVA|||||||0.017
71821137|NCT04212169|143144333|SUPERIORITY||Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|8.981||0.888|TWO_SIDED|90.0|-13.67|16.22|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||16.22|-13.67|0.888
71821138|NCT04212169|143144333|SUPERIORITY||Mean Difference (Final Values)|5.87|STANDARD_ERROR_OF_MEAN|9.756||0.549|TWO_SIDED|90.0|-10.36|22.1|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||22.10|-10.36|0.549
71821139|NCT04212169|143144333|SUPERIORITY||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|7.014||0.807|TWO_SIDED|90.0|-13.38|9.95|||Mixed Models Analysis||Differences less than 0 favours MEDI3506|||9.95|-13.38|0.807
71821140|NCT04212169|143144335|SUPERIORITY||Odds Ratio (OR)|1.53||||0.6396|TWO_SIDED|90.0|0.19|9.94|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||9.94|0.19|0.6396
71821141|NCT04212169|143144335|SUPERIORITY||Odds Ratio (OR)|0.76||||0.9999|TWO_SIDED|90.0|0.03|6.38|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||6.38|0.03|0.9999
71821142|NCT04212169|143144335|SUPERIORITY||Odds Ratio (OR)|2.89||||0.0935|TWO_SIDED|90.0|0.91|10.49|||Regression, Logistic||Odds ratio greater than 1 favours MEDI3506|||10.49|0.91|0.0935
71821143|NCT04212169|143144337|SUPERIORITY||Odds Ratio (OR)|3.06||||0.445|TWO_SIDED|90.0|0.08|119.65|||Fisher Exact||Odds ratio greater than one favour MEDI3506|||119.65|0.08|0.4450
71821144|NCT04212169|143144337|SUPERIORITY||Odds Ratio (OR)|0.0||||0.9999|TWO_SIDED|90.0|0.0|28.0|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||28.0|0.0|0.9999
71821145|NCT04212169|143144337|SUPERIORITY||Odds Ratio (OR)|5.5||||0.1132|TWO_SIDED|90.0|0.75|130.35|||Fisher Exact||Odds ratio greater than 1 favours MEDI3506|||130.35|0.75|0.1132
71852685|NCT03305458|143219491|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852686|NCT03305458|143219492|SUPERIORITY||||||||||||||||||response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider.|||
71821146|NCT03123263|143144364|OTHER|Repeated measures one sided ANOVA was used to analyze changes in ejection fraction over time.|||||<|0.0005|||||||ANOVA|F (2,98) =13.974||||||<0.0005
71821147|NCT00479037|143144399|SUPERIORITY_OR_OTHER||Mean Difference (Net)|360.3|||<|0.0001|TWO_SIDED|95.0|256.5|494.3||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||494.3|256.5|<0.0001
71852687|NCT03305458|143219493|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71821148|NCT00479037|143144400|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.9|||<|0.0001|TWO_SIDED|95.0|63.8|127.1||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||127.1|63.8|<0.0001
71821149|NCT00479037|143144401|SUPERIORITY_OR_OTHER||Mean Difference (Net)|138.5|||<|0.0001|TWO_SIDED|95.0|94.8|191.8||P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.||191.8|94.8|<0.0001
71821150|NCT03220737|143144436|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to co-primary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
71821151|NCT03220737|143144437|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
71821152|NCT03220737|143144438|NON_INFERIORITY|This analysis was based on the lower confidence limit and did not entail a comparative group. The requirement was for the lower limit of the 98.3% CI be at least 70%. Multiplicity adjustment due to coprimary endpoints allotted alpha=0.017 to this endpoint resulting in a 98.3% confidence interval.|Proportion|0.985|||||ONE_SIDED|98.3|0.7||||||||||0.7|
71852688|NCT03305458|143219494|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852689|NCT03305458|143219495|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852690|NCT03305458|143219496|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71852691|NCT03305458|143219497|SUPERIORITY||||||||||||||||||Response to the intervention will be evaluated with a piecewise longitudinal MLM that contains an additional level corresponding to time. Level-1 will correspond to time, level-2 to child, and level-3 to provider|||
71821153|NCT03220737|143144439|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|5.8|||||TWO_SIDED|96.7|2.4|7.1|||||Newcombe method of determining the difference between two independent binomial distributions|||7.1|2.4|
71821154|NCT03220737|143144440|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.3|||||TWO_SIDED|96.7|-0.3|6.2||||||||6.2|-0.3|
71821155|NCT03220737|143144441|NON_INFERIORITY|Non-inferiority was determined using the Newcombe method of determining the difference between two independent binomial distributions. Multiple comparison adjustment for co-primary endpoints allotted alpha=0.033 to this comparison. The lower limit of the 96.7% CI needed to be greater than -10 percentage points to prove non-inferiority.|Risk Difference (RD)|4.5|||||TWO_SIDED|96.7|-1.1|6.4||||||||6.4|-1.1|
71821156|NCT03220737|143144442|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71821157|NCT03220737|143144443|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71852692|NCT05431543|143219498|SUPERIORITY||Odds Ratio (OR)|83.988|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
71852693|NCT05431543|143219498|SUPERIORITY||Odds Ratio (OR)|102.093|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
71852694|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6409||||||Hochberg's adjustment was used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6409
71852695|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0140
71680144|NCT02231879|142878049|SUPERIORITY|This is a two-sided test, with the null hypothesis that the distribution of the difference scores is the same in both arms.||||||0.65||||||Not adjusted for multiple comparisons, since this is the only pre-specified primary analysis. P\<=0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||This was a pre-specified primary analysis plan, and the two arms are compared with a Wilcoxon-Mann-Whitney test on the primary outcome. This is non-standard (since both arms contain both treatment groups), however, it is a valid test by randomization since it is a permutation test. The statistic of TISS in Period 1 minus TISS in Period 2 was chosen so that even if there are carry-over effects this will give a valid test.||||0.65
71680145|NCT02231879|142878049|SUPERIORITY||||||<|0.0001||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute lymphocyte count greater than 1000 cells/microliter measured 3 hours after a dose for plerixafor as compared to G-CSF||||<0.0001
71680146|NCT02231879|142878049|NON_INFERIORITY|Pre-specified non-inferiority margin of 0.40 which was estimated to be about 50% of the effect size of G-CSF versus placebo.||||||0.023||||||Not adjusted for multiple comparisons, one-sided test, a priori significance set at 0.025|McNemar|||Maintenance of absolute neutrophil counts \>500 cells/microliter for G-CSF versus plerixafor measured as the proportion of successes (75% of measured) while on G-CSF minus the proportion on plerixafor||||0.023
71680147|NCT00985959|142878082|SUPERIORITY_OR_OTHER||Overall response rate (%)|69.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001|TWO_SIDED|95.0|58.9|79.2||Significance level 5% one-tailed. Threshold response rate 35%|Binominal test|||||79.2|58.9|<0.0001
71680148|NCT01777568|142878099|SUPERIORITY||Risk Ratio (RR)|0.99||||0.85|TWO_SIDED|95.0|0.85|1.14|||GEE model||Relative Risk: 80% (numerator) vs. 30% (denominator)|||1.14|0.85|0.85
71680149|NCT01777568|142878100|SUPERIORITY||Risk Ratio (RR)|0.8||||0.047|TWO_SIDED|95.0|0.66|1.01|||Chi-squared|||||1.01|0.66|0.047
71680150|NCT00844480|142878101|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
71680151|NCT02858180|142878104|OTHER||Proportion|86.7|||||TWO_SIDED|95.0|59.5|98.3||||||||98.3|59.5|
71680152|NCT00574249|142878126|SUPERIORITY_OR_OTHER|||||||0.086||||||Level of significance 5%; no adjustment for multiple comparisons necessary.|Cochran-Mantel-Haenszel|Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).||Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.||||0.086
71680153|NCT00574249|142878127|SUPERIORITY_OR_OTHER|||||||0.565||95.0|||||Fisher Exact|||||||0.565
71680154|NCT00574249|142878128|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||||||0.002
71821158|NCT03220737|143144444|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71902783|NCT04019093|143327158|SUPERIORITY|||||||0.98|||||||ANOVA|F(1,41)=.001||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the beverage condition X group interaction.||||.98
71902784|NCT04019093|143327158|SUPERIORITY|||||||0.71|||||||ANOVA|F(2,82)=.34||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of pressure level.||||.71
71680155|NCT00574249|142878129|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71821159|NCT03220737|143144448|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71821160|NCT03220737|143144449|SUPERIORITY|Fisher's exact test was used to compare Vaxchora vaccine to placebo on the percent of subjects who seroconverted. For Vaxchora vs placebo within each cohort at each Day on study timepoint, the p-value was the same (p\<0.0001).|||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71680156|NCT00574249|142878130|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|||||||0.004
71680157|NCT00574249|142878131|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
71680158|NCT00574249|142878132|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74||||0.204||95.0|-5.3|24.78|||ANOVA|One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.||||24.78|-5.30|0.204
71680159|NCT00574249|142878133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.55||||0.272||95.0|-48.92|13.82|||ANOVA|One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.||||13.82|-48.92|0.272
71680160|NCT00574249|142878134|SUPERIORITY_OR_OTHER|||||||0.413||95.0|||||Fisher Exact|||||||0.413
71680161|NCT00574249|142878135|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71680162|NCT00574249|142878136|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Fisher Exact|||||||0.028
71680163|NCT00574249|142878137|SUPERIORITY_OR_OTHER|||||||0.228||95.0|||||ANOVA|One-way ANOVA.||||||0.228
71680164|NCT00574249|142878138|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|One-way ANOVA.||||||< 0.001
71680165|NCT00574249|142878139|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|One-way ANOVA.||||||0.001
71680166|NCT00574249|142878140|SUPERIORITY_OR_OTHER|||||||0.764||95.0|||||ANOVA|One-way ANOVA.||||||0.764
71680167|NCT00574249|142878141|SUPERIORITY_OR_OTHER|||||||0.437||95.0|||||ANOVA|One-way ANOVA.||||||0.437
71680168|NCT00574249|142878142|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||ANOVA|One-way ANOVA.||||||0.740
71680169|NCT00574249|142878143|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANOVA|One-way ANOVA.||||||0.634
71680170|NCT00478699|142878158|SUPERIORITY||Hazard Ratio (HR)|0.946||||0.73|TWO_SIDED|95.0|0.689|1.298|||Log Rank|||Based on the relevant clinical evidence of the prognostic and predictive value of BRCA1, proposes the present study with which it is intended to demonstrate that adjuvant chemotherapy Individualized based on BRCA1 expression (Experimental arm), it is more effective than chemotherapy without individualize based (Control arm) in patients with completely resected stage II-IIIA NSCLC.||1.298|0.689|0.73
71680171|NCT00478699|142878159|SUPERIORITY||Median Difference (Final Values)|79.3||||0.753|TWO_SIDED|95.0|63.5|95.1|||Log Rank|||Control Arm v Experimental Arm||95.1|63.5|0.753
71680172|NCT00478699|142878159|SUPERIORITY|The initial hyphotesis were the disease free survival were longest under 65 vs upper 65.|Median Difference (Final Values)|38.7||||0.025|TWO_SIDED|95.0|28.0|38.7|||Log Rank|||Control Arm v Experimental Arm||38.7|28|0.025
71902785|NCT04019093|143327158|SUPERIORITY|||||||0.71|||||||ANOVA|F(1,41)=.14||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of group.||||.71
71902786|NCT04019093|143327158|SUPERIORITY||||||<|0.0001|||||||ANOVA|F(1,41)=55.02||2 (beverage condition: alcohol vs. placebo) X 2 (group: chronic pain vs. healthy control) x 2 (pressure level: 4 lbf vs. 5 lbf vs 6 lbf) mixed general linear model on pain relief. Here we report the results of the analysis of the main effect of beverage condition.||||<.0001
71852696|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4840
71852697|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4444||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4444
71852698|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8129||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8129
71852699|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.1105
71852700|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9582||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9582
71852701|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1893||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1893
71852702|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2924||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Hochberg's adjustment used for multiple comparisons adjustment||Week 5||||0.2924
71852703|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1897||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.1897
71852704|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6608||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.6608
71852705|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2148||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."||||0.2148
71852706|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.5290
71902787|NCT00471445|143327163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|STANDARD_ERROR_OF_MEAN|0.19||0.363|TWO_SIDED|95.0|-0.548|0.201|||ANCOVA|||Tested at the two-sided 0.05 significance level.||0.201|-0.548|0.363
71902788|NCT00962039|143327177|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.12|0.1||Analyses were conducted over 8 week follow-up.|Chi-squared|||||0.10|-0.12|0.92
71680173|NCT01005888|142878161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Observed number of attacks.|ANOVA|||||||<0.0001
71852707|NCT00141271|143219551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0811||||||Hochberg's adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.0811
71852708|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2287
71852709|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4734||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week1||||0.4734
71902789|NCT00962039|143327178|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.034|TWO_SIDED|95.0|-0.15|-0.01|||Chi-squared|||||-0.01|-0.15|0.034
71902790|NCT00962039|143327179|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.261|TWO_SIDED|95.0|-0.07|0.02|||t-test, 2 sided|||||0.02|-0.07|0.261
71902791|NCT00962039|143327180|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.09||||0.519|TWO_SIDED|95.0|-0.36|0.18|||t-test, 2 sided|||||0.18|-0.36|0.519
71680174|NCT01005888|142878161|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Normalized number of attacks.|ANOVA|||||||<0.0001
71680175|NCT01005888|142878162|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 1.|Fisher Exact|||||||>0.999
71680176|NCT01005888|142878162|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0||||Period 2.|Fisher Exact|||||||>0.999
71680177|NCT01005888|142878163|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
71680178|NCT01005888|142878164|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
71852710|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7401||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7401
71852711|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7904||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7904
71852712|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5274||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.5274
71852713|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1059||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.1059
71852714|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8871||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8871
71852715|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6939|||||||Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.6939
71852716|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1044||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.1044
71680179|NCT01005888|142878165|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71680180|NCT01005888|142878166|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71680181|NCT01005888|142878167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71852717|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3132||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.3132
71680182|NCT01005888|142878167|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71680183|NCT01005888|142878167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0||||Week 8 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0001
71680184|NCT01005888|142878167|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0028||95.0||||Week 12 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0028
71680185|NCT01005888|142878168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Visit 1 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71680186|NCT01005888|142878168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 4 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71680187|NCT01005888|142878168|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Week 8 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71680188|NCT01005888|142878168|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Week 12 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0002
71680189|NCT01043705|142878169|SUPERIORITY_OR_OTHER||One sided Fisher's exact test.|0.0044||||0.0023|ONE_SIDED|95.0||0.009|||Fisher Exact|||||0.009||0.0023
71680190|NCT01043705|142878169|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Text|0.002||||0.0052|ONE_SIDED|95.0||0.01|||Fisher Exact|||||0.01||0.0052
71680191|NCT01043705|142878169|SUPERIORITY_OR_OTHER||1-sided Fisher's Exact Test|0.006||||0.0176|ONE_SIDED|95.0||0.014|||Fisher Exact|||||0.014||0.0176
71680192|NCT01043705|142878169|SUPERIORITY_OR_OTHER||Fisher's Exact Test|0.7||||0.3764|TWO_SIDED|95.0|||||Fisher Exact|||||||0.3764
71680193|NCT01043705|142878170|SUPERIORITY_OR_OTHER||Rate compared to performance goal|4.4||||0.0005|TWO_SIDED|95.0|3.3|5.8|||1-sided Chi-square|||||5.8|3.3|0.0005
71680194|NCT01043705|142878170|SUPERIORITY_OR_OTHER||Rate compared to a performance goal|3.1||||0.0444|TWO_SIDED|95.0|1.7|5.1|||1-sided Chi-square test|||||5.1|1.7|0.0444
71852718|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6978||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6978
71852719|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3228
71852720|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6432
71852721|NCT00141271|143219552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5989||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.5989
71680195|NCT01043705|142878170|SUPERIORITY_OR_OTHER||rate compared to performance goal|5.4||||0.0006|TWO_SIDED|95.0|3.8|5.4|||1-sided Chi-squared test|||All types of mechanical complications combined.||5.4|3.8|0.0006
71680196|NCT01043705|142878170|SUPERIORITY_OR_OTHER||Descriptive|5.4||||0.0745|TWO_SIDED|95.0|3.7|7.5|||Chi-squared|||All mechanical complications, retrospective, non-TYRX cohort||7.5|3.7|0.0745
71680197|NCT04601103|142878189|OTHER|Generalized Fisher's Exact Test was used to detect an association between the 3 treatment groups and the incidence of sloughing||||||0.916|||||||Fisher Exact|||||||.916
71680198|NCT01623037|142878193|OTHER||sucess proportion|71.1|||||TWO_SIDED|95.0|55.7|83.6||||||||83.6|55.7|
71680199|NCT01203826|142878198|OTHER|||||||0.0005|||||||Wilcoxon signed-rank test|P-value based on Wilcoxon signed-rank test.||Change is relative to Baseline in Study ENB-006-09 (NCT00952484). The RGI-C score represents evaluations of skeletal X-rays at each post-treatment study timepoint in Study ENB-008-10 compared with pre-treatment X-rays from Study ENB-006-09, using an ordinal scale. Therefore, no Baseline data for RGI-C are available.||||0.0005
71852722|NCT00141271|143219553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8921||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.8921
71852723|NCT00141271|143219553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4350
71852724|NCT00141271|143219553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.562||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5620
71852725|NCT00141271|143219553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6959||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.6959
71852726|NCT00141271|143219553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7865||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7865
71852727|NCT00141271|143219553|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7564
71902792|NCT00962039|143327181|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.704|TWO_SIDED|95.0|-0.77|0.52|||t-test, 2 sided|||||0.52|-0.77|0.704
71852728|NCT00141271|143219554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4327||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4327
71902793|NCT00962039|143327182|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.59||||0.046|TWO_SIDED|95.0|0.01|1.17|||t-test, 2 sided|||||1.17|0.01|0.046
71680200|NCT03379753|142878261|OTHER||U statistic|984.5||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
71680201|NCT00347919|142878262|SUPERIORITY_OR_OTHER||Percentage difference|2.7||||0.3724||90.0|-11.0|16.3|||Chi-squared||Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||16.3|-11.0|0.3724
71680202|NCT00347919|142878262|SUPERIORITY_OR_OTHER||Percentage difference|5.4||||0.2578||90.0|-8.4|19.2|||Chi-squared||Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)|||19.2|-8.4|0.2578
71680203|NCT00347919|142878263|SUPERIORITY_OR_OTHER|||||||0.7488||95.0|||||Log Rank|||||||0.7488
71680204|NCT01032239|142878268|SUPERIORITY||Hodges-Lehmann|-0.667||||0.014|TWO_SIDED|95.1|-1.0|-0.1667|||Wilcoxon (Mann-Whitney)|||To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.||-0.1667|-1.000|0.0140
71680205|NCT01032239|142878269|SUPERIORITY||Hodges-Lehmann|-0.6||||0.0042|TWO_SIDED|95.0|-1.0|-0.2|||Wilcoxon (Mann-Whitney)|||||-0.2000|-1.0000|0.0042
71680206|NCT01032239|142878270|SUPERIORITY|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||||||0.0540
71680207|NCT01032239|142878271|SUPERIORITY|||||||0.6256|||||||Wilcoxon (Mann-Whitney)|||||||0.6256
71680208|NCT01032239|142878272|SUPERIORITY|||||||0.3676|||||||Cochran-Mantel-Haenszel|||||||0.3676
71680209|NCT01032239|142878273|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Actual Pain||||0.0380
71680210|NCT01032239|142878273|SUPERIORITY|||||||0.0136|||||||Wilcoxon (Mann-Whitney)|||Least Pain||||0.0136
71680211|NCT01032239|142878273|SUPERIORITY|||||||0.2427|||||||Wilcoxon (Mann-Whitney)|||Worst Pain||||0.2427
71852729|NCT00141271|143219554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7041||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7041
71852730|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2076||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.2076
71852731|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7449||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.7449
71902794|NCT01067508|143327183|OTHER|||||||0.003||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to 12 weeks minus baseline change in Fiji water group||||0.003
71902795|NCT01067508|143327183|OTHER|||||||0.68||||||p\<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to the 12 week minus baseline change in Aquafina (control) group||||0.68
71902796|NCT04594239|143327223|SUPERIORITY||Difference in response rates|78.7|||||TWO_SIDED|95.0|66.3|85.6||||||||85.6|66.3|
71680212|NCT01032239|142878274|SUPERIORITY|||||||0.7661|||||||Fisher Exact|||||||0.7661
71680213|NCT01032239|142878275|SUPERIORITY|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||Utility Score||||0.0197
71680214|NCT01032239|142878275|SUPERIORITY|||||||0.3807|||||||t-test, 2 sided|||VAS||||0.3807
71680215|NCT01032239|142878276|SUPERIORITY|||||||0.1068|||||||t-test, 2 sided|||PCS||||0.1068
71680216|NCT01032239|142878276|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||MCS||||0.6824
71680217|NCT01032239|142878277|SUPERIORITY|||||||0.2105|||||||t-test, 2 sided|||||||0.2105
71902797|NCT04594239|143327223|SUPERIORITY||Difference in response rates|85.4|||||TWO_SIDED|95.0|70.5|92.3||||||||92.3|70.5|
71902798|NCT04594239|143327223|SUPERIORITY||Difference in response rates|71.8|||||TWO_SIDED|95.0|55.2|82.5||||||||82.5|55.2|
71902799|NCT00091390|143327229|SUPERIORITY_OR_OTHER_LEGACY||hazard rate|0.0014|||<|0.0001|TWO_SIDED|95.0|0.0|0.003|||Z-test|One-sided.||The study is designed to test whether the 18-month late GU/GI toxicity following the protocol treatment is above 10% (hazard rate of 0.012/month). The sample size is determined so that the probability of rejecting the treatment because of excessive late toxicity is 90% if the true late toxicity rate is 20% (hazard rate of 0.025/month). Ninety-eight patients are required to with an additional 18 months of follow-up to have a statistical power of 90% with one-sided significance level of 0.05.||0.003|0|<0.0001
71902800|NCT03229759|143327237|SUPERIORITY||Mean Difference (Final Values)|1.48|||||TWO_SIDED|95.0|0.88|2.08||||||Test on abdomen Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||2.08|0.88|
71680218|NCT04713592|142878295|SUPERIORITY||Rate Difference|17.2|||=|0.006|TWO_SIDED|95.0|5.0|29.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||29.3|5.0|=0.006
71680219|NCT04713592|142878297|SUPERIORITY||Rate Difference|27.6|||<|0.001|TWO_SIDED|95.0|15.4|39.7||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||39.7|15.4|<0.001
71680220|NCT04713592|142878298|SUPERIORITY||Rate Difference|21.8|||<|0.001|TWO_SIDED|95.0|11.5|32.1||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.1|11.5|<0.001
71902801|NCT03229759|143327237|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.72|1.96||||||Tested on the abdomen Analysis was performed based on deferral letters from the FDA. Average treatment effect was calculated using a linear regression model for each body site was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.||1.96|0.72|
71902802|NCT03229759|143327237|SUPERIORITY||Mean Difference (Final Values)|1.93|||||TWO_SIDED|95.0|1.38|2.47||||||Groin||2.47|1.38|
71680221|NCT04713592|142878299|SUPERIORITY||Rate Difference|20.7|||<|0.001|TWO_SIDED|95.0|9.1|32.2||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||32.2|9.1|<0.001
71680222|NCT04713592|142878300|SUPERIORITY||Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|8.2|24.3||P-value based on Cochran-Mantel-Haenszel (CMH) test adjusted for Baseline ppIGA and Baseline BSA categories for comparison of treatment groups based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19.|Cochran-Mantel-Haenszel||Difference: Risankizumab - Placebo|Risankizumab vs Placebo at Week 16||24.3|8.2|<0.001
71680223|NCT02426749|142878322|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71680224|NCT02294175|142878356|SUPERIORITY|||||||0.029||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.029
71821161|NCT00594932|143144474|SUPERIORITY_OR_OTHER_LEGACY||superiority|4.0|||=|0.041||||||This was the primary endpoint therefore no adjustment for multiple comparisons was necessary|Fisher Exact|||this is a categorical assessment. Prespecified. Fishers exact test. Significant is calculated as \< 0.05||||=0.041
71821162|NCT01676220|143144476|NON_INFERIORITY_OR_EQUIVALENCE|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~1. Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is \<0.4%.~2. Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is \<0."|Least Squares (LS) Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.067|||TWO_SIDED|95.0|-0.09|0.174||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.||0.174|-0.090|
71902803|NCT03229759|143327237|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|0.73|1.79||||||Groin||1.79|0.73|
71902804|NCT03050359|143327240|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.4|||||TWO_SIDED|95.0|-2.998|3.791||||||||3.791|-2.998|
71852732|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4399||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.4399
71902805|NCT03050359|143327241|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-10%, the HP eradication rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|4.7|||||TWO_SIDED|95.0|-1.281|10.69||||||||10.690|-1.281|
71902806|NCT03050359|143327242|NON_INFERIORITY|If the lower bound of the 95% CI was ≥-6%, the DU healing rate for TAK-438 was considered to be noninferior to that seen with lansoprazole.|Exact (Clopper-Pearson)|0.7|||||TWO_SIDED|95.0|-4.901|6.319||||||||6.319|-4.901|
71902807|NCT03050359|143327243|OTHER||Difference in percentages|-4.1|||||TWO_SIDED|95.0|-15.579|7.344||||||Epigastric Pain (Postprandial)||7.344|-15.579|
71902808|NCT03050359|143327243|OTHER||Difference in percentages|1.6|||||TWO_SIDED|95.0|-5.23|8.422||||||Epigastric Pain (Fasting/Nocturnal)||8.422|-5.230|
71902809|NCT03050359|143327243|OTHER||Difference in percentages|-4.0|||||TWO_SIDED|95.0|-17.338|9.401||||||Abdominal Bloating||9.401|-17.338|
71902810|NCT03050359|143327243|OTHER||Difference in percentages|-9.3|||||TWO_SIDED|95.0|-26.334|7.815||||||Nausea/Vomiting||7.815|-26.334|
71902811|NCT03050359|143327243|OTHER||Difference in percentages|4.5|||||TWO_SIDED|95.0|-4.159|13.25||||||Heartburn||13.250|-4.159|
71902812|NCT03050359|143327243|OTHER||Difference in percentages|-9.1|||||TWO_SIDED|95.0|-21.104|2.922||||||Lack of Appetite||2.922|-21.104|
71902813|NCT02614287|143327245|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71902814|NCT02614287|143327249|SUPERIORITY|||||||0.215|||||||Fisher Exact|||TE ADA Positive (TE ADA+)||||.215
71902815|NCT02614287|143327250|SUPERIORITY||LSMean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.46||0.6|TWO_SIDED|95.0|-1.76|0.04|||Mixed Models Analysis|||||0.04|-1.76|0.60
71902816|NCT02614287|143327251|SUPERIORITY||LSMean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.41||0.835|TWO_SIDED|95.0|-0.72|0.89|||Mixed Models Analysis|||||0.89|-0.72|.835
71902817|NCT02614287|143327252|SUPERIORITY||Odds Ratio (OR)|1.467||||0.063|TWO_SIDED|95.0|0.979|2.197|||CPLRM|CPLRM: Categorical pseudo likelihood-based repeated measures model||||2.197|0.979|.063
71852733|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7107||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.7107
71852734|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4765||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.4765
71852735|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.2564
71852736|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8063||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.8063
71902818|NCT02614287|143327253|SUPERIORITY||LSMean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.937|TWO_SIDED|95.0|-0.96|1.04|||Mixed Models Analysis|||||1.04|-0.96|.937
71902819|NCT02614287|143327254|SUPERIORITY||LSMean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.1||0.073|TWO_SIDED|95.0|-0.4|0.02|||Mixed Models Analysis|||||0.02|-0.40|0.073
71902820|NCT02614287|143327255|SUPERIORITY||LSMean Difference|0.91|STANDARD_ERROR_OF_MEAN|2.82||0.747|TWO_SIDED|95.0|-4.65|6.47|||Mixed Models Analysis|||||6.47|-4.65|.747
71902821|NCT02614287|143327256|SUPERIORITY||LSMean Difference|1.98|STANDARD_ERROR_OF_MEAN|1.55||0.203|TWO_SIDED|95.0|-1.07|5.03|||Mixed Models Analysis|||Total Score||5.03|-1.07|0.203
71902822|NCT02614287|143327256|SUPERIORITY||LSMean Difference|1.85|STANDARD_ERROR_OF_MEAN|1.59||0.247|TWO_SIDED|95.0|-1.29|4.98|||Mixed Models Analysis|||Role Function-Restrictive Domain Score||4.98|-1.29|.247
71902823|NCT02614287|143327256|SUPERIORITY||LSMean Difference|1.26|STANDARD_ERROR_OF_MEAN|1.49||0.399|TWO_SIDED|95.0|-1.67|4.19|||Mixed Models Analysis|||Role Function-Preventive Domain Score||4.19|-1.67|0.399
71902824|NCT02614287|143327256|SUPERIORITY||LSMean Difference|3.09|STANDARD_ERROR_OF_MEAN|1.8||0.88|TWO_SIDED|95.0|-0.46|6.64|||Mixed Models Analysis|||Emotional Function Domain Score||6.64|-0.46|0.88
71902825|NCT01156597|143327259|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values||||||0.05
71902826|NCT00401622|143327313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.56|STANDARD_ERROR_OF_MEAN|7.51||0.31|TWO_SIDED|95.0|-7.24|22.36|||t-test, 2 sided|||||22.36|-7.24|0.31
71902827|NCT00401622|143327314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.11||0.45|TWO_SIDED|95.0|-0.38|0.04|||ANCOVA|Visit 1 A1c measurement used as the covariate||Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS||0.04|-0.38|0.45
71902828|NCT00520676|143327322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.34|0.6||The comparison was conducted at a 1-sided significance level of 0.05.|Log Rank|Note that the 2-sided p-value for log rank is reported, which is \<0.001, hence 1-sided p-value is \<0.001.|Cox regression model is used for HR estimate.|||0.60|0.34|<0.001
71902829|NCT00520676|143327323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.934|TWO_SIDED|95.0|0.72|1.42||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.42|0.72|0.934
71902830|NCT00520676|143327324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8|TWO_SIDED|95.0|0.72|1.29||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank|Cox regression model is used for hazard ratio (HR) estimate.||||1.29|0.72|0.800
71902831|NCT00520676|143327325|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.081|TWO_SIDED|95.0|0.93|3.15||The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.|Fisher Exact|Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.|Logistic regression model is used for odds ratio (OR) estimate.|||3.15|0.93|0.081
71852737|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9855||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.9855
71852738|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0599||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0599
71852739|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7364||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.7364
71852740|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.3048
71852741|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5139||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6||||0.5139
71852742|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9356||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9356
71852743|NCT00141271|143219555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9428
71852744|NCT00141271|143219556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3888||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3888
71852745|NCT00141271|143219556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3122||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.3122
71852746|NCT00141271|143219556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3323||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.3323
71902832|NCT00520676|143327326|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.641|TWO_SIDED|95.0|0.49|1.55||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.|||1.55|0.49|0.641
71902833|NCT00520676|143327327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53|||<|0.001|TWO_SIDED|95.0|0.4|0.71||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.71|0.40|<0.001
71902834|NCT00520676|143327328|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.35|0.66||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.|||0.66|0.35|<0.001
71852747|NCT00141271|143219556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8781||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.8781
71852748|NCT00141271|143219556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9485||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.9485
71852749|NCT00141271|143219556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7331||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.7331
71852750|NCT00141271|143219557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4869||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.4869
71852751|NCT00141271|143219557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5813||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3||||0.5813
71852752|NCT00141271|143219557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.3303
71902835|NCT00115349|143327342|SUPERIORITY_OR_OTHER|||||||0.89||0.0|||||Mixed Models Analysis|Linear mixed models with treatment, time, and treatment x time interaction were used, allowing for random participant-specific intercepts and slopes.||The intended sample size of 86 patients (N=43 per arm) had 80% power to detect a 5% difference in LVEF between the two arms after 1 year of treatment, assuming a standard deviation of change in LVEF of 7.46%, and 20% loss to follow-up. The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.||||0.89
71902836|NCT00506077|143327371|SUPERIORITY_OR_OTHER|||||||0.939||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained longitudinal data analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.939
71902837|NCT00506077|143327372|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-Value Comments (limit 250 characters): The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
71902838|NCT00506077|143327373|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
71902839|NCT00506077|143327374|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Logitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.||||||0.736
71902840|NCT00818324|143327379|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2|t-test, 2 sided|||||||<0.001
71680225|NCT02294175|142878357|SUPERIORITY|||||||0.037||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p\<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.037
71902841|NCT00818324|143327379|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
71902842|NCT00818324|143327379|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
71902843|NCT00818324|143327379|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
71902844|NCT00818324|143327380|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2.|t-test, 2 sided|||||||<0.001
71902845|NCT00818324|143327380|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided|||||||<0.001
71902846|NCT00818324|143327380|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided|||||||<0.001
71902847|NCT00818324|143327380|SUPERIORITY_OR_OTHER||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided|||||||<0.001
71902848|NCT02336594|143327404|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio (%)|107.0|||||TWO_SIDED|90.0|95.2|120.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||120|95.2|
71902849|NCT02336594|143327406|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|97.3|||||TWO_SIDED|90.0|85.6|111.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||111|85.6|
71902850|NCT02336594|143327407|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|100.0|||||TWO_SIDED|90.0|87.3|115.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||115|87.3|
71902851|NCT02336594|143327409|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|182.0|||||TWO_SIDED|90.0|144.0|230.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||230|144|
71902852|NCT02336594|143327410|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|140.0|||||TWO_SIDED|90.0|121.0|163.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||163|121|
71902853|NCT02336594|143327411|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|134.0|||||TWO_SIDED|90.0|114.0|156.0|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||156|114|
71680226|NCT02294175|142878358|SUPERIORITY|||||||0.012||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.||||.012
71680227|NCT02294175|142878359|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||.397
71680228|NCT02294175|142878360|SUPERIORITY|||||||0.661||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.||||.661
71902854|NCT02336594|143327412|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|79.1|||||TWO_SIDED|90.0|66.4|94.2|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.2|66.4|
71902855|NCT02336594|143327413|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|85.5|||||TWO_SIDED|90.0|73.9|98.8|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||98.8|73.9|
71902856|NCT02336594|143327414|NON_INFERIORITY_OR_EQUIVALENCE|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|83.4|||||TWO_SIDED|90.0|73.5|94.7|||Mixed Models Analysis|A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.||||94.7|73.5|
71902857|NCT01212172|143327426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.9||||0.2879|TWO_SIDED|95.0|-6.7|21.1|||t-test, 1 sided|||||21.1|-6.7|0.2879
71902858|NCT02868216|143327448|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|0.84||0.05|TWO_SIDED|95.0|0.63|3.98|||ANOVA|||||3.98|0.63|0.05
71902859|NCT04891770|143327450|OTHER||percentage difference|2.5|||||TWO_SIDED|95.0|-2.3|7.3|||||For Cohort 2A versus Cohort 2B, the percentage difference and the corresponding 95% confidence interval was calculated using the stratum-adjusted Mantel-Haenszel method, stratified by HBsAg group (\> 3 and ≤ 3 log10 IU/mL).|||7.3|-2.3|
71902860|NCT04026412|143327455|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.646|TWO_SIDED|96.0|0.77|1.19|||Cox proportional hazards model|||||1.19|0.77|0.6460
71902861|NCT04026412|143327456|SUPERIORITY||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.87|1.41||||||||1.41|0.87|
71902862|NCT04026412|143327456|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.75|1.22||||||||1.22|0.75|
71902863|NCT04026412|143327456|SUPERIORITY||Hazard Ratio, log|1.16|||||TWO_SIDED|95.0|0.91|1.48||||||||1.48|0.91|
71680229|NCT02294175|142878361|SUPERIORITY|||||||0.979||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.||||.979
71902864|NCT04026412|143327457|SUPERIORITY||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.69|1.05||||||||1.05|0.69|
71902865|NCT04026412|143327457|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.93|1.42||||||||1.42|0.93|
71902866|NCT04026412|143327458|SUPERIORITY||Difference in ORR|3.2|||||TWO_SIDED|95.0|-4.1|10.6||||||||10.6|-4.1|
71902867|NCT04026412|143327458|SUPERIORITY||Difference in ORR|7.8|||||TWO_SIDED|95.0|0.7|14.8||||||||14.8|0.7|
71902868|NCT04026412|143327458|SUPERIORITY||Difference in ORR|-4.7|||||TWO_SIDED|95.0|-11.8|2.5||||||||2.5|-11.8|
71902869|NCT04026412|143327461|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.82|1.23||||||||1.23|0.82|
71902870|NCT04026412|143327461|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.7|1.05||||||||1.05|0.70|
71902871|NCT04026412|143327461|SUPERIORITY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.44||||||||1.44|0.95|
71902872|NCT04026412|143327462|SUPERIORITY||Difference in ORR|3.5|||||TWO_SIDED|95.0|-4.1|11.1||||||||11.1|-4.1|
71902873|NCT04026412|143327462|SUPERIORITY||Difference in ORR|5.4|||||TWO_SIDED|95.0|-2.0|12.9||||||||12.9|-2.0|
71902874|NCT04026412|143327462|SUPERIORITY||Difference in ORR|-1.9|||||TWO_SIDED|95.0|-9.5|5.6||||||||5.6|-9.5|
71902875|NCT04026412|143327465|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.76|1.23||||||||1.23|0.76|
71902876|NCT04026412|143327465|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.65|1.06||||||||1.06|0.65|
71902877|NCT04026412|143327465|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.91|1.49||||||||1.49|0.91|
71902878|NCT00904826|143327469|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between before treatment and one year after treatment.||||<0.0001
71902879|NCT00904826|143327471|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was made between baseline and after 12 months of treatment.||||0.0078
71902880|NCT00904826|143327475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 weeks and baseline.||||<0.0001
71902881|NCT00904826|143327475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 3 months and baseline.||||<0.0001
71902882|NCT00904826|143327475|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 months and baseline||||0.0001
71902883|NCT00904826|143327475|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 9 months and baseline.||||0.0001
71902884|NCT00904826|143327475|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison is between 12 months and baseline.||||<0.0001
71902885|NCT00904826|143327477|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison was between 3 months and baseline.||||0.0019
71902886|NCT02094586|143327521|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.92|||||TWO_SIDED|95.0|0.78|1.08||||||Lot A vs. Lot B||1.08|0.78|
71902887|NCT02094586|143327526|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.2||||||Lot B vs Lot C||1.20|0.87|
71902888|NCT02094586|143327527|EQUIVALENCE|The GMT of each lot was required to be within ±50% of each other lot with 95% confidence. Specifically, the 95% CI around each pairwise ratio of GMTs was required to be within \[0.67, 1.5\].|Geometric Mean Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.1||||||Lot A vs. Lot C||1.10|0.80|
71902889|NCT02761993|143327528|SUPERIORITY|||||||0.341||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equation|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.341
71852753|NCT00141271|143219557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1546||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6||||0.1546
71852754|NCT00141271|143219557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8982||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.8982
71852755|NCT00141271|143219557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3586
71852756|NCT00141271|143219558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0896||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.0896
71852757|NCT00141271|143219558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6534||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6534
71852758|NCT00141271|143219558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.3270
71852759|NCT00141271|143219558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4099
71852760|NCT00141271|143219558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6104||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6104
71852761|NCT00141271|143219558|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9359||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9359
71852762|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6924||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6924
71902890|NCT02761993|143327528|SUPERIORITY|||||||0.774||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.774
71852763|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0800
71852764|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4238||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4238
71852765|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7714||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.7714
71902891|NCT02761993|143327529|SUPERIORITY|||||||0.501||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.501
71852766|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8731||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8731
71852767|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.8926
71852768|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2072||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.2072
71852769|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.1042
71852770|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2695||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.2695
71852771|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3245
71852772|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7791||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.7791
71852773|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0999||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.0999
71852774|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9543||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.9543
71852775|NCT00141271|143219559|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3153
71852776|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2878||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.2878
71852777|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4481||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.4481
71852778|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.4099
71852779|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5093||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 2||||0.5093
71852780|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value.||Week 3||||0.8048
71852781|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0552||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0552
71852782|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9795||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.9795
71852783|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5073||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.5073
71852784|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4882
71852785|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3967||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3967
71852786|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8276||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8276
71852787|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8502||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8502
71902892|NCT02761993|143327529|SUPERIORITY|||||||0.486||||||Since there were two (2) primary hypotheses, Bonferroni corrections were used to control for multiplicity, with p \< 0.025 considered significant.|Generalized Estimating Equations|Generalized estimating equations (GEE) method with a linear link and exchangeable covariance matrix (with subject correlation structure)||||||0.486
71902893|NCT02761993|143327530|SUPERIORITY|||||||0.816|||||||ANCOVA|||||||0.816
71902894|NCT02761993|143327530|SUPERIORITY|||||||0.706|||||||ANCOVA|||||||0.706
71902895|NCT01842620|143327531|EQUIVALENCE|Geometric means ratio for AUC (0-t) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-36)*100|100.0|||||TWO_SIDED|90.0|92.62|107.98|||||Ratio of AUC0-36= (AUC0-36 of Test)/ AUC 0-36 Reference)|Overall period||107.98|92.62|
71852788|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6343||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6343
71852789|NCT00141271|143219560|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.3082
71852790|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.6932
71852791|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 1||||0.0287
71902896|NCT01842620|143327532|EQUIVALENCE|Geometric means ratio for AUC(0-inf) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-inf)*100|99.02|||||TWO_SIDED|90.0|92.26|106.27|||||Ratio of AUC0-inf= (AUC0-inf of Test) / (AUC 0-inf of Reference)|For overall period||106.27|92.26|
71902897|NCT01842620|143327533|EQUIVALENCE|Geometric means ratio for Cmax of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of Cmax)*100|98.34|||||TWO_SIDED|90.0|88.54|109.22|||||Ratio of Cmax= (Cmax of Test) / (Cmax of Reference)|Overall period||109.22|88.54|
71902898|NCT00875017|143327556|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-65.75|||<|0.001||95.0|-96.01|-35.49|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-35.49|-96.01|<0.001
71902899|NCT00875017|143327556|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-125.65|||<|0.001||95.0|-155.91|-95.39|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-95.39|-155.91|<0.001
71902900|NCT00875017|143327556|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-59.9|||<|0.001||95.0|-89.87|-29.93|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-29.93|-89.87|<0.001
71902901|NCT00875017|143327557|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|71.9|||<|0.001||95.0|40.03|103.77|||Mixed Models Analysis|||Phosphorus binding was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||103.77|40.03|<0.001
71902902|NCT00875017|143327558|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.67||||0.049||95.0|-41.22|-0.13|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||-0.13|-41.22|0.049
71902903|NCT00875017|143327558|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.56||||0.133||95.0|-36.11|4.99|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||4.99|-36.11|0.133
71902904|NCT00875017|143327558|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.11||||0.612||95.0|-15.24|25.47|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.||25.47|-15.24|0.612
71902905|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
71821163|NCT01676220|143144477|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.89||||0.4536|TWO_SIDED|95.0|0.66|1.2|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (\<8.0, \>=8.0%), randomization strata of geographical region (Non-Japan; Japan).||1.20|0.66|0.4536
71902906|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
71902907|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
71902908|NCT03342469|143327559|OTHER|||||||0.08||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.08
71680230|NCT02294175|142878362|SUPERIORITY|||||||0.999|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.999
71902909|NCT03342469|143327559|OTHER|||||||0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,14)= 4.55||Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||0.05
71902910|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
71902911|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
71902912|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC) This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons.||||>0.05
71902913|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)||||>0.05
71680231|NCT02294175|142878363|SUPERIORITY|||||||0.415|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.415
71902914|NCT03342469|143327559|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902915|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71680232|NCT02294175|142878364|SUPERIORITY|||||||0.993|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.993
71680233|NCT02294175|142878365|SUPERIORITY|||||||0.99|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).||||.990
71680234|NCT02548351|142878366|OTHER||Hazard Ratio (HR)|0.814||||0.1028|TWO_SIDED|95.0|0.635|1.043|||Log Rank|||||1.043|0.635|0.1028
71680235|NCT02548351|142878366|OTHER||Hazard Ratio (HR)|0.772||||0.0444|TWO_SIDED|95.0|0.6|0.994|||Log Rank|||||0.994|0.600|0.0444
71680236|NCT02548351|142878367|OTHER||Difference in percentages|7.1|||<|0.0001|TWO_SIDED|95.0|3.6|10.6|||Cochran-Mantel-Haenszel|||||10.6|3.6|<0.0001
71680237|NCT02548351|142878367|OTHER||Treatment difference|9.4|||<|0.0001|TWO_SIDED|95.0|5.8|13.0|||Cochran-Mantel-Haenszel|||||13.0|5.8|<0.0001
71680238|NCT02548351|142878368|OTHER||Treatment difference|6.7||||0.0004|TWO_SIDED|95.0|3.0|10.4|||Cochran-Mantel-Haenszel|||||10.4|3.0|0.0004
71680239|NCT02548351|142878368|OTHER||Treatment difference|9.0|||<|0.0001|TWO_SIDED|95.0|5.2|12.8|||Cochran-Mantel-Haenszel|||||12.8|5.2|<0.0001
71680240|NCT00792688|142878370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0062||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0062
71680241|NCT00792688|142878370|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0331||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0331
71680242|NCT00125242|142878372|SUPERIORITY_OR_OTHER||effect size|7.15|STANDARD_DEVIATION|3.1|||TWO_SIDED||||||||the reported effect size is a d-index value|Effect sizes were calculated - this is a comparison of perfomance in baseline (repeated measurements prior to treatment) relative to peformance following treatment||||
71680243|NCT05238025|142878384|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|42.9|||||TWO_SIDED|95.0|-16.1|71.9||||||||71.9|-16.1|
71680244|NCT05238025|142878385|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if the first primary outcome is met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|59.0|||||TWO_SIDED|95.0|34.7|74.3|||||Not formally tested, since the first primary outcome was not met|||74.3|34.7|
71821164|NCT01676220|143144478|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.224|||TWO_SIDED|95.0|-0.275|0.605||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (\<8.0, \>=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.||0.605|-0.275|
71821165|NCT01232556|143144503|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.083||||0.708|TWO_SIDED|95.0|0.82|1.44||A one sided 0.025 level testing plan was specified with two interim analyses and final testing level at one-sided 0.023.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline Secondary International Prognostic Index (sIPI), and best response to most recent chemo therapy.|Primary null hypothesis: Equality of survival distributions. Sample size sufficient to have power 0.96 for an experimental/control hazard ratio of 0.6.||1.44|0.82|0.708
71821166|NCT01232556|143144504|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.924||||0.271|TWO_SIDED|95.0|0.72|1.19||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|Second comparison in hierarchical testing strategy was used for power calculation.||1.19|0.72|0.271
71821167|NCT01232556|143144505|SUPERIORITY_OR_OTHER|||||||0.843||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.843
71821168|NCT01232556|143144506|SUPERIORITY_OR_OTHER|||||||0.714||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.||||0.714
71821169|NCT01232556|143144507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.142|TWO_SIDED|95.0|0.47|1.25|||Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|DOR was not part of the formal hypothesis testing strategy.||1.25|0.47|0.142
71680245|NCT05238025|142878386|OTHER|Vaccine Efficacy (VE) is defined as 1 minus the hazard ratio resulting from a Cox proportional hazards regression model stratified by age group. It is demonstrated if both primary outcomes are met and the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE is above 20%|Vaccine Efficacy|48.8|||||TWO_SIDED|95.0|25.8|64.7|||||Not formally tested, since the first primary outcome was not met|||64.7|25.8|
71680246|NCT03197324|142878410|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|100.4|||||TWO_SIDED|90.0|86.49|116.56|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||116.56|86.49|
71680247|NCT03197324|142878413|SUPERIORITY|Compare if co-administration of digoxin with bexagliflozin had significant impact on the PK of digoxin|Ratio of Geometric LSM|106.12|||||TWO_SIDED|90.0|95.82|117.53|||||Digoxin group is the denominator and Digoxin with Bexagliflozin is the numerator. Confidence interval from ANOVA with treatment, period, and sequence as fixed effects, and subjects as a random effect.|Geometric LS Mean was used as PK parameters||117.53|95.82|
71680248|NCT03051516|142878418|SUPERIORITY|||||||0.89|||||||Chi-squared|||This p-value compares HPV16 persistence by study arm.||||0.89
71680249|NCT03051516|142878418|SUPERIORITY|||||||0.65|||||||Chi-squared|||This p-value compares HPV18/45 persistence by study arm.||||0.65
71680250|NCT03051516|142878418|SUPERIORITY|||||||0.056|||||||Chi-squared|||This p-value compares HPV31/33/52/58 persistence by study arm.||||0.056
71821170|NCT01232556|143144508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.2892|TWO_SIDED|95.0|-0.02|0.06|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||0.06|-0.02|0.2892
71821171|NCT01232556|143144509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.11||||0.1879|TWO_SIDED|95.0|-1.52|7.74|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.||||7.74|-1.52|0.1879
71821172|NCT01473420|143144528|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|95.0|-0.17|0.24||||||Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.||0.24|-0.17|
71821173|NCT01473420|143144529|NON_INFERIORITY_OR_EQUIVALENCE|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-2.34|STANDARD_ERROR_OF_MEAN|6.175|||TWO_SIDED|95.0|-14.51|9.82||||||LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.||9.82|-14.51|
71821174|NCT01473420|143144530|SUPERIORITY_OR_OTHER|||||||0.8338|||||||Two-sample t-test|||||||0.8338
71821175|NCT01473420|143144531|SUPERIORITY_OR_OTHER|||||||0.6895|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.6895
71821176|NCT01473420|143144532|SUPERIORITY_OR_OTHER|||||||0.9177|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.||||||0.9177
71821177|NCT03862482|143144560|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.22|-0.49||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 35 Brånemark® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.49|-1.22|<0.05
71821178|NCT03862482|143144560|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-1.35|-0.64||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Swede-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-0.64|-1.35|<0.05
71821179|NCT03862482|143144560|EQUIVALENCE|Intraclass Correlation Coefficient (ICC, two-way mixed-effect model) assessed inter- and intra-examiner reliability of bone level measurement on 20 radiographs. Dahlberg measurement error. Two-way, mixed effect model|Median Difference (Final Values)|-1.77|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|-2.13|-1.41||Bonferroni correction was applied for pairwise comparisons|ANOVA|Repeated measures ANOVA. Dahlberg measurement error||Total 36 Screw-Vent® implants analyzed for all Configurations. Size difference expected 0.95 bone level change between B/SW/SC. Sample size 16 participants ensured 80% power to reject null hypothesis (two-sided Bonferroni-adjusted α level 0.017, pairwise comparisons between implant groups). Repeated measures ANOVA. Mixed models, repeated measures within subject. Implant type/site/configuration independent variables (length covariate). (B/SW/SC lengths compared with Kruskal-Wallis test)||-1.41|-2.13|<0.05
71852792|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2128||95.0||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.2128
71680251|NCT03051516|142878418|SUPERIORITY|||||||0.38|||||||Chi-squared|||This p-value compares HPV35/39/51/56/59 persistence by study arm.||||0.38
71680252|NCT03051516|142878418|SUPERIORITY|||||||0.33||||||This p-value compares overall HPV persistence and is not specific to HPV genotype.|Chi-squared|||||||0.33
71680253|NCT03051516|142878419|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
71680254|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.135|||||||Chi-squared|||This comparison is specific to the incidence of fever or chills.||||0.135
71680255|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.64|||||||Chi-squared|||This comparison is specific to the incidence of headache.||||0.640
71680256|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.838|||||||Chi-squared|||This comparison is specific to the incidence of fatigue.||||0.838
71902916|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Theta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902917|NCT03342469|143327560|OTHER|||||||0.04||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1.14)= 4.88, p=0.04||"Difference in Alpha Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||0.04
71902918|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902919|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in ADHD group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902920|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Delta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902921|NCT03342469|143327560|OTHER||||||>|0.05|||||||repeated measures General Linear Model|||"Difference in Theta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons"||||>0.05
71902922|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Alpha Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902923|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Beta Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902924|NCT03342469|143327560|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in Gamma Power in control group with and without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (EEG power during AFC, EEG power during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71680257|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.917|||||||Chi-squared|||This comparison is specific to the incidence of muscle aches.||||0.917
71680258|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.005|||||||Chi-squared|||This comparison is specific to the incidence of pain at injection site.||||0.005
71821180|NCT02040090|143144587|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We will reject the null hypothesis at the one-sided 5% significance level, and conclude that Cp \> -0.1, if the lower bound of an exact 90% binomial confidence interval (CI) exceeds0.1. A sample size of 53 in each group provides 80% power to reject the null hypothesis.|Mean Difference (Net)|-0.018|||||TWO_SIDED|90.0|-0.082|0.031||||||The null hypothesis was that Cp ≤ -0.1.||0.031|-0.082|
71821181|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|0.031||0.79|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||The null hypothesis was the that proportions of patients with at least one OAC filled at one year were the same between the two groups.||1.07|0.95|0.79
71821182|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.04|STANDARD_ERROR_OF_MEAN|0.039||0.307|TWO_SIDED|95.0|0.96|1.12|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 183 days were the same between the two groups.||1.12|0.96|0.307
71821183|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.052||0.375|TWO_SIDED|95.0|0.95|1.16|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 90 days were the same between the two groups.||1.16|0.95|0.375
71852793|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1118||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 2||||0.1118
71852794|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.6144
71852795|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 3||||0.0899
71852796|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8819||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8819
71852797|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 4||||0.8374
71852798|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3925||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.3925
71852799|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4182||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 5||||0.4182
71852800|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.8586
71852801|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.549||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Week 6||||0.5490
71852802|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6292||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.6292
71852803|NCT00141271|143219561|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1473||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp \& treatment-by-visit interaction \& fixed continuous effect of baseline value||Overall||||0.1473
71852804|NCT00141271|143219562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2058||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.2058
71852805|NCT00141271|143219562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9254||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.9254
71852806|NCT00141271|143219562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5071||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.5071
71902925|NCT03342469|143327561|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|F(1,15) = 3.65, p = 0.08||"Difference in inattentive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902926|NCT03342469|143327561|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in hyperactive ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902927|NCT03342469|143327561|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in ADHD group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902928|NCT03342469|143327561|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"inattentive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (inattentive ASRS score during AFC, inattentive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902929|NCT03342469|143327561|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Hyperactive ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (hyperactive ASRS score during AFC, hyperactive ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902930|NCT03342469|143327561|OTHER||||||>|0.05||||||Significance level \</= 0.05. This was chosen due to the small sample size. The p-value is not adjusted for multiple comparisons as this was a pilot study and a power analysis for sample size was not conducted.|repeated measures General Linear Model|||"Difference in total ASRS in control group with/without exposure to AFC. General linear model assessed the impact of treatment (AFC v. placebo) on each EEG frequency band, taking into account order of materials. Dependent variable = Treatment (total ASRS score during AFC, total ASRS score during placebo); independent variable = order (AFC/placebo, placebo/AFC)~This is a pilot study, thus a power calculation was not done and it was not power to correct for multiple comparisons."||||>0.05
71902931|NCT02932475|143327562|SUPERIORITY||Odds Ratio (OR)|0.86|||||TWO_SIDED|95.0|0.63|1.19|||||The odds ratio was calculated and adjusted for study site, timing of diabetes diagnosis, gestational age at randomization stratified at 18 weeks, and baseline maternal BMI.|The sample size gave adequate power over a range of expected primary outcome event rates, with type I error set at 0.044 (reduced from 0.05 for interim analysis), with reasonable power under a conservative scenario assuming that 20% of subjects immediately stopped taking study agent.||1.19|0.63|
71902932|NCT02932475|143327563|SUPERIORITY||Difference in proportions|0.2||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|Chi-squared|||||||0.4
71902933|NCT02932475|143327564|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4|TWO_SIDED|||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided||comparison of mean (sd) between groups|||||0.4
71821184|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.09|STANDARD_ERROR_OF_MEAN|0.076||0.265|TWO_SIDED|95.0|0.94|1.26|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled at 42 days were the same between the two groups.||1.26|0.94|0.265
71902934|NCT02932475|143327565|SUPERIORITY||Difference in proportions|0.0||||0.6|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.6
71902935|NCT02932475|143327566|SUPERIORITY||Difference in proportions|0.0||||0.08|TWO_SIDED|||||The a priori threshold for statistical significance is \<0.05.|Chi-squared|||||||0.08
71821185|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.05|STANDARD_ERROR_OF_MEAN|0.044||0.237|TWO_SIDED|95.0|0.97|1.15|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among females were the same between the two groups.||1.15|0.97|0.237
71902936|NCT02322320|143327567|SUPERIORITY|||||||0.6||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.60
71902937|NCT02322320|143327567|SUPERIORITY|||||||0.35||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.35
71902938|NCT02322320|143327567|SUPERIORITY|||||||0.68||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.68
71902939|NCT02322320|143327568|SUPERIORITY|||||||0.57||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.57
71902940|NCT02322320|143327568|SUPERIORITY|||||||0.38||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.38
71902941|NCT02322320|143327568|SUPERIORITY|||||||0.77||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.77
71902942|NCT02322320|143327569|SUPERIORITY|||||||0.67||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.67
71902943|NCT02322320|143327569|SUPERIORITY|||||||0.2||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.20
71902944|NCT02322320|143327569|SUPERIORITY|||||||0.4||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.40
71902945|NCT02322320|143327570|SUPERIORITY|||||||0.43||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.||||0.43
71902946|NCT02322320|143327570|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.||||0.70
71902947|NCT02322320|143327570|SUPERIORITY|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.||||0.70
71902948|NCT00125658|143327585|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.||||<.001
71821186|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|0.97|STANDARD_ERROR_OF_MEAN|0.042||0.487|TWO_SIDED|95.0|0.89|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among males were the same between the two groups.||1.05|0.89|0.487
71902949|NCT00125658|143327585|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.||||.002
71902950|NCT00125658|143327586|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).||||0.13
71902951|NCT00125658|143327586|SUPERIORITY_OR_OTHER|||||||0.048|||||||t-test, 2 sided|||Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.||||0.048
71902952|NCT00125658|143327587|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.||||.004
71902953|NCT00125658|143327587|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.||||0.034
71902954|NCT00125658|143327588|SUPERIORITY_OR_OTHER|||||||0.056|||||||t-test, 2 sided|||Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.||||0.056
71902955|NCT00125658|143327588|SUPERIORITY_OR_OTHER|||||||0.168|||||||t-test, 2 sided|||Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.||||.168
71902956|NCT00125658|143327589|SUPERIORITY_OR_OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.||||0.564
71902957|NCT00125658|143327589|SUPERIORITY_OR_OTHER|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.||||0.948
71902958|NCT00125658|143327590|SUPERIORITY_OR_OTHER|||||||0.078|||||||t-test, 2 sided|||Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.||||0.078
71902959|NCT00125658|143327590|SUPERIORITY_OR_OTHER|||||||0.4|||||||t-test, 2 sided|||Tests the effect of treatment order (Order A (FTP \> POWER) vs. Order B (POWER \> FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.||||0.4
71902960|NCT00125658|143327591|SUPERIORITY_OR_OTHER|||||||0.085|||||||t-test, 2 sided|||Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.||||0.085
71821187|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.125||0.952|TWO_SIDED|95.0|0.78|1.27|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \<= 64 yrs were the same between the two groups.||1.27|0.78|0.952
71902961|NCT00125658|143327591|SUPERIORITY_OR_OTHER|||||||0.635|||||||t-test, 2 sided|||Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.||||0.635
71902962|NCT02876055|143327592|SUPERIORITY|||||||0.542|||||||Wilcoxon (Mann-Whitney)|||||||0.542
71902963|NCT02876055|143327592|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71902964|NCT02876055|143327592|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71902965|NCT00364845|143327594|SUPERIORITY_OR_OTHER||Proportion achieving target|0.389||||||95.0|0.173|0.643||||||||0.643|0.173|
71902966|NCT00364845|143327594|SUPERIORITY_OR_OTHER||Proportion achieving target|0.95||||||95.0|0.751|0.999||||||||0.999|0.751|
71902967|NCT03453151|143327614|OTHER|||||||0.053|||||||Paired t-test|||||||0.053
71902968|NCT03453151|143327615|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71902969|NCT03453151|143327616|OTHER||||||<|0.001|||||||Paired t-test|||||||<0.001
71902970|NCT03453151|143327617|OTHER|||||||0.077|||||||Paired t-test|This analysis refers to the resting cardiac index.||||||0.077
71902971|NCT03453151|143327617|OTHER|||||||0.069|||||||Paired t-test|This analysis refers to the peak exercise cardiac index.||||||0.069
71902972|NCT03453151|143327619|OTHER|||||||0.25|||||||Paired t-test|This analysis refers to creatinine level.||||||0.250
71902973|NCT03453151|143327619|OTHER|||||||0.014|||||||Paired t-test|This analysis refers to BUN level.||||||0.014
71902974|NCT03007485|143327631|SUPERIORITY||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0||||Reported p-value was calculated|t-test, 2 sided|||Sample size and power calculation was a composite of COPD-related hospital readmissions or death within 6 months of discharge. First level of analysis was the ITT, which included all the patients randomly assigned to an arm at the beginning of the study (excluding those who were found to not meet inclusion criteria for referral). The second included all the patients medically cleared and third included all the patients who were medically cleared and who had participated in at least 1 PR session.|"The primary outcome was a composite of COPD-related hospital readmissions or death within 6 months of discharge (binary: yes/no). Logistic regression was used to compare the primary outcome in terms of the OR of event rates between the 2 arms, in 3 sets of models (per each of the 3 aforementioned level of analyses):~* Model 1: Treatment arm only with no other covariates added to the model~* Model 2: Treatment arm, adjusted for race and clinical site (stratification variables)~* Model 3: Treatment arm, adjusted for race, clinical site, and risk factors reported in the literature to be associated with the primary outcome, for explanatory purposes To examine the role of adherence on the primary outcome, we included adherence as a binary variable and as a continuous variable (percentage of sessions attended) in the 3 models."|||<.05
71821188|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.057||0.696|TWO_SIDED|95.0|0.91|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among age 65 - 74 yrs were the same between the two groups.||1.14|0.91|0.696
71821189|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.047||0.584|TWO_SIDED|95.0|0.94|1.13|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age 75 - 84 yrs were the same between groups.||1.13|0.94|0.584
71821190|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.069||0.911|TWO_SIDED|95.0|0.87|1.14|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among age \>= 85 yrs were the same between the two groups.||1.14|0.87|0.911
71821191|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.057||0.746|TWO_SIDED|95.0|0.88|1.1|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of the patients with at least one OAC filled among those with a CHADS-VASC of 2-3 were the same between the two groups.||1.10|0.88|0.746
71821192|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|1.08|STANDARD_ERROR_OF_MEAN|0.048||0.109|TWO_SIDED|95.0|0.98|1.19|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score of 4-5 were the same between the two groups.||1.19|0.98|0.109
71821193|NCT03259373|143144590|SUPERIORITY||Odds Ratio (OR)|0.94|STANDARD_ERROR_OF_MEAN|0.057||0.244|TWO_SIDED|95.0|0.84|1.05|||fixed-effect meta-analysis|||The null hypothesis was that the proportions of patients with at least one OAC filled among those with a CHADS-VASC score \>=6 were the same between the two groups.||1.05|0.84|0.244
71821194|NCT03259373|143144591|SUPERIORITY||Hazard Ratio (HR)|0.92|STANDARD_ERROR_OF_MEAN|0.079||0.3|TWO_SIDED|95.0|0.79|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.79|0.300
71821195|NCT03259373|143144592|SUPERIORITY||Hazard Ratio (HR)|1.31|STANDARD_ERROR_OF_MEAN|0.172||0.122|TWO_SIDED|95.0|0.93|1.83|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.83|0.93|0.122
71821196|NCT03259373|143144593|SUPERIORITY||Hazard Ratio (HR)|0.98|STANDARD_ERROR_OF_MEAN|0.073||0.76|TWO_SIDED|95.0|0.85|1.13|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.13|0.85|0.760
71821197|NCT03259373|143144594|SUPERIORITY||Hazard Ratio (HR)|0.99|STANDARD_ERROR_OF_MEAN|0.072||0.76|TWO_SIDED|95.0|0.86|1.14|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.14|0.86|0.760
71821198|NCT03259373|143144595|SUPERIORITY||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.052||0.616|TWO_SIDED|95.0|0.88|1.08|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.08|0.88|0.616
71821199|NCT03259373|143144596|SUPERIORITY||Hazard Ratio (HR)|1.0|STANDARD_ERROR_OF_MEAN|0.072||0.992|TWO_SIDED|95.0|0.87|1.15|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.15|0.87|0.992
71821200|NCT03259373|143144597|SUPERIORITY||Hazard Ratio (HR)|1.01|STANDARD_ERROR_OF_MEAN|0.029||0.808|TWO_SIDED|95.0|0.95|1.07|||fixed-effect meta-analysis|||||1.07|0.95|0.808
71821201|NCT03259373|143144598|SUPERIORITY||Standardized Mean Difference (%)|-0.51|STANDARD_ERROR_OF_MEAN|0.027||0.853|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.853
71821202|NCT03259373|143144599|SUPERIORITY||Odds Ratio (OR)|0.93|STANDARD_ERROR_OF_MEAN|0.066||0.303|TWO_SIDED|95.0|0.82|1.06|||fixed-effect meta-analysis|||||1.06|0.82|0.303
71821203|NCT03259373|143144600|SUPERIORITY||Hazard Ratio (HR)|1.03|STANDARD_ERROR_OF_MEAN|0.063||0.649|TWO_SIDED|95.0|0.91|1.16|||fixed-effect meta-analysis|||There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Therefore, depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include in the meta-analysis.||1.16|0.91|0.649
71821204|NCT03259373|143144601|SUPERIORITY||Standardized Mean Difference (%)|-0.4998|STANDARD_ERROR_OF_MEAN|0.009||0.587|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.587
71821205|NCT03259373|143144601|SUPERIORITY||Standardized Mean Difference (%)|-0.4655|STANDARD_ERROR_OF_MEAN|0.009||0.613|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.613
71821206|NCT03259373|143144601|SUPERIORITY||Standardized Mean Difference (%)|0.598|STANDARD_ERROR_OF_MEAN|0.009||0.515|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.515
71902975|NCT01848054|143327636|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
71902976|NCT01848054|143327643|NON_INFERIORITY_OR_EQUIVALENCE|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥-10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.||||||<0.05
71821207|NCT03259373|143144601|SUPERIORITY||Standardized Mean Difference (%)|-2.17|STANDARD_ERROR_OF_MEAN|0.009||0.018|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.018
71821208|NCT03259373|143144601|SUPERIORITY||Standardized Mean Difference (%)|0.05|STANDARD_ERROR_OF_MEAN|0.009||0.956|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.956
71821209|NCT03259373|143144602|SUPERIORITY||Standardized Mean Difference (%)|-1.018|STANDARD_ERROR_OF_MEAN|0.009||0.279|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.279
71821210|NCT03259373|143144602|SUPERIORITY||Standardized Mean Difference (%)|-1.347|STANDARD_ERROR_OF_MEAN|0.009||0.143|TWO_SIDED||||||fixed-effect meta-analysis|||||||0.143
71821211|NCT04894903|143144603|OTHER||Odds Ratio (OR)|0.45|||<|0.001|TWO_SIDED|95.0|0.3|0.68||This is the calculated p-value. We used an alpha level of 0.05|Mixed Models Analysis|Adjusted for baseline number of gaps||||0.68|0.30|<0.001
71852807|NCT00141271|143219562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2858||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2858
71852808|NCT00141271|143219562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6298||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6298
71852809|NCT00141271|143219562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6034
71680259|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.001|||||||Chi-squared|||This comparison is specific to the incidence of tenderness at injection site.||||0.001
71821212|NCT04894903|143144605|OTHER||Odds Ratio (OR)|0.57||||0.29|TWO_SIDED|95.0|0.2|1.62|||Mixed Models Analysis|||||1.62|0.20|0.29
71821213|NCT04894903|143144606|OTHER||beta coefficient|-0.04||||0.74|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||0.17|-0.24|0.74
71821214|NCT04894903|143144607|OTHER||beta coefficient|-0.04||||0.88|TWO_SIDED|95.0|-0.6|0.51|||Mixed Models Analysis|||||0.51|-0.60|0.88
71821215|NCT04894903|143144608|OTHER||beta coefficient|-1.24||||0.21|TWO_SIDED|95.0|-3.19|0.71|||Mixed Models Analysis|||||0.71|-3.19|0.21
71852810|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1454||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1||||0.1454
71821216|NCT04894903|143144611|OTHER||beta coefficient|0.47||||0.21|TWO_SIDED|95.0|-0.27|1.22|||Mixed Models Analysis|||||1.22|-0.27|0.21
71821217|NCT03990363|143144677|SUPERIORITY|||||||0.0648|||||||Repeated Measures Mixed Model|||||||0.0648
71821218|NCT03990363|143144677|SUPERIORITY|||||||0.6296|||||||Repeated Measures Mixed Model|||||||0.6296
71821219|NCT03990363|143144677|SUPERIORITY|||||||0.0263|||||||Repeated Measures Mixed Model|||||||0.0263
71852811|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2672||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 1||||0.2672
71852812|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2614||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 2||||0.2614
71852813|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2||||0.2143
71852814|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.6997
71902977|NCT01826422|143327658|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
71680260|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.004|||||||Chi-squared|||This comparison is specific to the incidence of swelling at injection site.||||0.004
71821220|NCT00556374|143144705|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.504|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Cox Proportional Hazards Model|Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.|From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.|The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).||0.65|0.39|<0.0001
71821221|NCT00556374|143144706|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|10.02|||<|0.0001|TWO_SIDED|95.0|9.04|11.01||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||11.01|9.04|<0.0001
71821222|NCT00556374|143144707|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|7.92|||<|0.0001|TWO_SIDED|95.0|6.87|8.97||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||8.97|6.87|<0.0001
71852815|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3||||0.0128
71852816|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1144
71902978|NCT01826422|143327659|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
71902979|NCT01826422|143327660|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||>0.05
71902980|NCT01826422|143327661|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
71902981|NCT01826422|143327662|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||<0.05
71821223|NCT00556374|143144708|SUPERIORITY_OR_OTHER_LEGACY||Difference from Placebo|6.51|||<|0.0001|TWO_SIDED|95.0|5.62|7.39||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.||||7.39|5.62|<0.0001
71852817|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4||||0.1483
71680261|NCT03051516|142878420|OTHER|Descriptive analysis||||||0.133|||||||Chi-squared|||This comparison is specific to the incidence of medical attention/medication required.||||0.133
71680262|NCT03051516|142878421|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm I (Vaccine)||||0.93
71680263|NCT03051516|142878421|SUPERIORITY|||||||0.77|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm I (Vaccine)||||0.77
71902982|NCT01826422|143327663|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
71902983|NCT01826422|143327664|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
71902984|NCT01826422|143327665|SUPERIORITY_OR_OTHER||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
71902985|NCT01826422|143327666|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||<0.05
71902986|NCT01826422|143327667|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
71902987|NCT01826422|143327668|SUPERIORITY||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||<0.05
71902988|NCT01826422|143327669|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided|||||||0.05
71902989|NCT01826422|143327670|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
71902990|NCT01826422|143327671|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
71902991|NCT01826422|143327672|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
71902992|NCT01826422|143327673|SUPERIORITY_OR_OTHER||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
71902993|NCT01826422|143327674|SUPERIORITY||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||>0.05
71821224|NCT00556374|143144709|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.53||||0.0088|TWO_SIDED|95.0|0.33|0.85|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.85|0.33|0.0088
71902994|NCT01826422|143327675|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis|||||||0.05
71902995|NCT01826422|143327676|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
71902996|NCT01826422|143327677|SUPERIORITY|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)|||||||0.05
71902997|NCT03439748|143327685|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.002
71902998|NCT03439748|143327686|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||>.05
71902999|NCT03439748|143327687|SUPERIORITY|||||||0.024||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.||||.024
71903000|NCT03439748|143327691|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.922
71903001|NCT03439748|143327692|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.049
71821225|NCT00556374|143144710|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.54||||0.007|TWO_SIDED|95.0|0.34|0.84|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values \< 1 for odds ratio favor denosumab.|||0.84|0.34|0.0070
71821226|NCT00556374|143144711|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.0515|TWO_SIDED|95.0|0.66|1.0|||Cox Proportional Hazards Model|Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).|From the Cox Proportional hazards model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio \< 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.|||1.00|0.66|0.0515
71821227|NCT00556374|143144712|SUPERIORITY|Analysis of BMFS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.808|||||TWO_SIDED|95.0|0.654|0.997|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer bone metastases-free time for denosumab relative to placebo.|||0.997|0.654|
71903002|NCT03439748|143327693|SUPERIORITY|||||||0.591||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.591
71903003|NCT03439748|143327694|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.004
71903004|NCT03439748|143327695|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.030
71903005|NCT03439748|143327696|SUPERIORITY|||||||0.029||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.029
71903006|NCT03439748|143327698|SUPERIORITY|||||||0.494||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.494
71903007|NCT03439748|143327699|SUPERIORITY|||||||0.231||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.231
71903008|NCT03439748|143327700|SUPERIORITY|||||||0.344||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.344
71903009|NCT03439748|143327701|SUPERIORITY|||||||0.267||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.267
71903010|NCT03439748|143327702|SUPERIORITY|||||||0.051||||||The threshold for statistical significance was p = 0.05. Univariate tests were corrected for false discovery rate using the Benjamin-Hochberg approach.|Mixed Models Analysis|Baseline levels of outcomes were covaried in all analyses to reduce error variance and correct for group differences.||This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.||||.051
71903011|NCT00782418|143327705|SUPERIORITY_OR_OTHER||Least Squares Mean|1.6|||<|0.001||90.0|1.29|1.92||1-sided, alpha=0.05|ANOVA|||||1.92|1.29|<0.001
71903012|NCT00782418|143327705|SUPERIORITY_OR_OTHER||Least Squares Mean|0.95|||<|0.001||90.0|0.66|1.24|||ANOVA|1-sided, alpha=0.05||||1.24|0.66|<0.001
71903013|NCT00782418|143327705|SUPERIORITY_OR_OTHER||Least Squares Mean|2.32|||<|0.001||90.0|1.57|3.06|||ANOVA|1-sided, alpha=0.05||||3.06|1.57|<0.001
71903014|NCT00782418|143327705|SUPERIORITY_OR_OTHER||Least Squares Mean|1.38|||<|0.001||90.0|0.64|2.12|||ANOVA|1-sided, alpha = 0.05||||2.12|0.64|<0.001
71903015|NCT00782418|143327706|SUPERIORITY_OR_OTHER||Least Squares Mean|23.1|||<|0.001||90.0|19.2|27.0|||ANOVA|1-side, alpha = 0.05||||27.0|19.2|<0.001
71903016|NCT00782418|143327706|SUPERIORITY_OR_OTHER||Least Squares Mean|16.4|||<|0.001||90.0|12.6|20.1|||ANOVA|1-side, alpha = 0.05||||20.1|12.6|<0.001
71903017|NCT00782418|143327707|SUPERIORITY_OR_OTHER||Least Squares Mean|545.0|||<|0.001||90.0|451.4|638.7|||ANOVA|1-side, alpha = 0.05||||638.7|451.4|<0.001
71903018|NCT00782418|143327707|SUPERIORITY_OR_OTHER||Least Squares Mean|246.6|||<|0.001||90.0|160.9|323.3|||ANOVA|1-side, alpha = 0.05||||323.3|160.9|<0.001
71903019|NCT02902172|143327764|NON_INFERIORITY||Mean Difference (Net)|0.85|||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71903020|NCT01125176|143327811|OTHER|Exact Clopper-Pearson 95% confidence interval for overall response rate.|Proportion (percent)|85.7|||||TWO_SIDED|95.0|73.5|100.0||||||||100.0|73.5|
71903021|NCT04360187|143327816|SUPERIORITY||LS mean of difference|-17.13||||0.0002|TWO_SIDED|95.0|-25.98|-8.27|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-8.27|-25.98|0.0002
71903022|NCT04360187|143327820|SUPERIORITY||Risk Difference (RD)|12.9||||0.0124|TWO_SIDED|95.0|2.8|23.1|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||23.1|2.8|0.0124
71903023|NCT04360187|143327821|SUPERIORITY||Risk Difference (RD)|11.7||||0.0078|TWO_SIDED|95.0|3.1|20.3|||normal approximation to response rates||Crisaborole = Test Vehicle = Reference|||20.3|3.1|0.0078
71903024|NCT04360187|143327822|SUPERIORITY||LS Mean of Difference|-0.79||||0.0009|TWO_SIDED|95.0|-1.26|-0.33|||Mixed effect Model for Repeated Measures||Crisaborole = Test Vehicle = Reference|||-0.33|-1.26|0.0009
71903025|NCT01318083|143327853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.936|||||TWO_SIDED|95.0|-1.097|-0.775||||||||-0.775|-1.097|
71903026|NCT01318083|143327853|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.998|||||TWO_SIDED|95.0|-1.16|-0.837||||||||-0.837|-1.160|
71903027|NCT01318083|143327854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.196|||||TWO_SIDED|95.0|-0.261|-0.131||||||||-0.131|-0.261|
71903028|NCT01318083|143327854|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|||||TWO_SIDED|95.0|-0.273|-0.154||||||||-0.154|-0.273|
71903029|NCT01318083|143327855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|||||TWO_SIDED|95.0|-0.507|-0.312||||||||-0.312|-0.507|
71903030|NCT01318083|143327855|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.453|||||TWO_SIDED|95.0|-0.547|-0.358||||||||-0.358|-0.547|
71903031|NCT01318083|143327856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.834|-0.556||||||||-0.556|-0.834|
71903032|NCT01318083|143327856|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-0.911|-0.629||||||||-0.629|-0.911|
71903033|NCT01318083|143327857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.71|||||TWO_SIDED|95.0|-24.6|-10.83||||||||-10.83|-24.60|
71903034|NCT01318083|143327857|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.59|||||TWO_SIDED|95.0|-24.93|-10.25||||||||-10.25|-24.93|
71903035|NCT01318083|143327858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.17|||||TWO_SIDED|95.0|-30.33|-16.02||||||||-16.02|-30.33|
71903036|NCT01318083|143327858|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.88|||||TWO_SIDED|95.0|-32.33|-17.43||||||||-17.43|-32.33|
71903037|NCT01318083|143327859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.62|||||TWO_SIDED|95.0|-35.32|-19.91||||||||-19.91|-35.32|
71903038|NCT01318083|143327859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.72|||||TWO_SIDED|95.0|-30.76|-14.69||||||||-14.69|-30.76|
71903039|NCT01318083|143327860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.37|||||TWO_SIDED|95.0|-37.14|-19.59||||||||-19.59|-37.14|
71903040|NCT01318083|143327860|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.93|||||TWO_SIDED|95.0|-30.33|-13.54||||||||-13.54|-30.33|
71852818|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0674||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.0674
71852819|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5||||0.2900
71852820|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5482||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.5482
71852821|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6||||0.0303
71852822|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.6143
71852823|NCT00141271|143219563|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3385||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint||||0.3385
71852824|NCT00141271|143219564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3299||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3299
71852825|NCT00141271|143219564|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1915||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1915
71852826|NCT00141271|143219565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5407||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5407
71903041|NCT01318083|143327861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.41|||||TWO_SIDED|95.0|-36.58|-10.23||||||||-10.23|-36.58|
71903042|NCT01318083|143327861|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.18|||||TWO_SIDED|95.0|-33.4|-4.95||||||||-4.95|-33.40|
71821228|NCT00556374|143144713|SUPERIORITY|Analysis of OS was conditional on the outcome of DFS due to hierarchical testing strategy, therefore p-value not reported.|Hazard Ratio (HR)|0.802|||||TWO_SIDED|95.0|0.635|1.013|||||A hazard ratio \< 1.0 indicates a lower average event rate and a longer overall survival time for denosumab relative to placebo.|||1.013|0.635|
71821229|NCT00519636|143144716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.24|<|0.001||95.0|-1.3|-0.3|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo.|FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) \& 2 (Placebo FF/FP).||-0.3|-1.3|<0.001
71821230|NCT00519636|143144716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.014||95.0|-1.1|-0.1|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo.|FPNS combined across treatment arms 1 (FPNS/FFNS) \& 2 (Placebo FP/FF) compared with Placebo FPNS combined across treatment arms 1 (FPNS/FFNS)\& 2 (Placebo FP/FF).||-0.1|-1.1|0.014
71821231|NCT00519636|143144717|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximate to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||||||<0.001
71821232|NCT00950937|143144723|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
71821233|NCT00950937|143144723|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821234|NCT00950937|143144723|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71852827|NCT00141271|143219565|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6079||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6079
71852828|NCT00141271|143219566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8464||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8464
71852829|NCT00141271|143219566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4023||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.4023
71852830|NCT00141271|143219566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.287||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2870
71852831|NCT00141271|143219566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.2537
71903043|NCT00256867|143327862|SUPERIORITY_OR_OTHER||Ratio Expressed as percent difference|-37.186|||<|0.0001|TWO_SIDED|95.0|-41.219|-32.879|||ANCOVA||Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use|||-32.879|-41.219|<0.0001
71821235|NCT00950937|143144724|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
71852832|NCT00141271|143219566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7909||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7909
71821236|NCT00950937|143144724|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821237|NCT00950937|143144724|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821238|NCT00950937|143144725|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
71821239|NCT00950937|143144725|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821240|NCT00950937|143144725|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821241|NCT00950937|143144726|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
71821242|NCT00950937|143144726|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821243|NCT00950937|143144726|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821244|NCT00950937|143144727|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
71821245|NCT00950937|143144727|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821246|NCT00950937|143144727|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821247|NCT00950937|143144728|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.||||||<0.05
71821248|NCT00950937|143144728|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821249|NCT00950937|143144728|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences||||||<0.05
71821250|NCT00950937|143144729|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|Paired t-test was utilized to compare the two groups (HIV group and Control group)||||||<0.05
71821251|NCT00462644|143144771|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
71821252|NCT00462644|143144772|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||||||0.011
71821253|NCT00462644|143144773|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||||||0.007
71821254|NCT00462644|143144774|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||t-test, 2 sided|||Normality was tested using the Kolmogorow-Smirnov test.||||0.022
71852833|NCT00141271|143219566|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3308||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3308
71852834|NCT00141271|143219567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3355||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.3355
71852835|NCT00141271|143219567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8447||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8447
71821255|NCT00462644|143144775|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71821256|NCT00462644|143144776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71821257|NCT00904150|143144809|SUPERIORITY_OR_OTHER|||||||0.513|||||||Chi-squared|||Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups||||0.513
71821258|NCT00904150|143144810|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups||||0.75
71821259|NCT00904150|143144811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.434||||0.002743||95.0|0.24|0.75|||Chi-squared|||Analysis of distribution of TNF genotype frequencies between groups||0.75|0.24|0.002743
71852836|NCT00141271|143219567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8959||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.8959
71852837|NCT00141271|143219567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4826||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.4826
71852838|NCT00141271|143219567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4178||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4178
71852839|NCT00141271|143219567|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8277||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8277
71852840|NCT00141271|143219568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7758||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.7758
71852841|NCT00141271|143219568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8737
71852842|NCT00141271|143219568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1151
71852843|NCT00141271|143219568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.129||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.1290
71852844|NCT00141271|143219568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4432
71903044|NCT00256867|143327863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.55|||ANCOVA||Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use|||-0.55|-1.09|<0.0001
71852845|NCT00141271|143219568|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2988||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2988
71852846|NCT00141271|143219569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8598||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.8598
71852847|NCT00141271|143219569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6513||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3||||0.6513
71852848|NCT00141271|143219569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6272||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6272
71852849|NCT00141271|143219569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6467||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6||||0.6467
71852850|NCT00141271|143219569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8049||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.8049
71852851|NCT00141271|143219569|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9411||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.9411
71852852|NCT00141271|143219570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9260
71852853|NCT00141271|143219570|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7100
71852854|NCT00141271|143219571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1836||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1836
71852855|NCT00141271|143219571|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1374
71852856|NCT00141271|143219572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9237||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.9237
71852857|NCT00141271|143219572|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3786||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3786
71852858|NCT00141271|143219573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4624||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4624
71852859|NCT00141271|143219573|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5971|||||||ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5971
71821260|NCT00904150|143144812|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.02462||95.0|0.49|0.95|||Chi-squared|||Analysis of distribution of SYNE1 genotype frequencies between groups||0.95|0.49|0.02462
71821261|NCT00904150|143144813|SUPERIORITY_OR_OTHER|||||||0.18|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups||||0.18
71821262|NCT00904150|143144814|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71852860|NCT00141271|143219574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1378||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1378
71852861|NCT00141271|143219574|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7665
71852862|NCT00141271|143219575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4767||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.4767
71852863|NCT00141271|143219575|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2066||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2066
71852864|NCT00141271|143219576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1667||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1667
71903045|NCT00256867|143327867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|36.32|||<|0.0001||95.0|16.52|79.85|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c \< 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups|||79.85|16.52|<.0001
71903046|NCT00256867|143327868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.05|||<|0.0001|TWO_SIDED|95.0|2.32|7.07|||ANCOVA||Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c \< 7% or reduction of HbA1c \>= 0.7% at Week 16 on All FDC group compared to Simv group.|||7.07|2.32|<0.0001
71680264|NCT03051516|142878421|SUPERIORITY|||||||0.57|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm I (Vaccine)||||0.57
71821263|NCT00904150|143144815|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71821264|NCT02718417|143144856|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.989|TWO_SIDED|95.0|1.051|1.946||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.946|1.051|0.9890
71852865|NCT00141271|143219576|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6727||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6727
71852866|NCT00141271|143219577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7019||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7019
71852867|NCT00141271|143219577|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1020
71852868|NCT00141271|143219578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4749||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4749
71821265|NCT02718417|143144856|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7935|TWO_SIDED|95.0|0.832|1.565||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||1.565|0.832|0.7935
71821266|NCT02718417|143144857|SUPERIORITY||Hazard Ratio (HR)|1.53||||0.8848|TWO_SIDED|95.0|0.76|3.08||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.080|0.760|0.8848
71852869|NCT00141271|143219578|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4491||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4491
71852870|NCT00141271|143219579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4398||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4398
71852871|NCT00141271|143219579|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3331||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3331
71852872|NCT00141271|143219580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2763||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2763
71852873|NCT00141271|143219580|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2048||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2048
71903047|NCT00256867|143327869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.93|||<|0.0001|TWO_SIDED|95.0|2.21|7.0|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG \< 7.0 mmol/L or reduction of FPG \>= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.|||7|2.21|<0.0001
71903048|NCT02993224|143327875|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.75|0.89|||McNemar|||Preference for deferasirox DT vs deferasirox FCT||0.89|0.75|<.0001
71852874|NCT00141271|143219581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.434||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.4340
71852875|NCT00141271|143219581|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.7774
71852876|NCT00141271|143219582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5195||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.5195
71852877|NCT00141271|143219582|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.0153
71852878|NCT00141271|143219583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2847||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint||||0.2847
71852879|NCT00141271|143219583|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1958||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1958
71852880|NCT00141271|143219584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1652||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.1652
71852881|NCT00141271|143219584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5997
71852882|NCT00141271|143219585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.0082
71852883|NCT00141271|143219585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7037||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7037
71903049|NCT02993224|143327876|SUPERIORITY||Difference of proportion|0.78|||<|0.0001|TWO_SIDED|95.0|0.65|0.88|||McNemar|||Preference of deferasirox FCT vs deferasirox DT||0.88|0.65|<0.0001
71903050|NCT02993224|143327876|SUPERIORITY||Difference of proportion|0.83|||<|0.0001|TWO_SIDED|95.0|0.71|0.91|||McNemar|||Preference for deferasirox FCT vs previous iron chelation therapy||0.91|0.71|<0.0001
71852884|NCT00141271|143219586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2718||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.2718
71903051|NCT02993224|143327877|SUPERIORITY||Difference of proportion|0.66|||<|0.0001|TWO_SIDED|95.0|0.51|0.77|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 4||0.77|0.51|< 0.0001
71903052|NCT02993224|143327877|SUPERIORITY||Difference of proportion|0.59|||<|0.0001|TWO_SIDED|95.0|0.44|0.72|||McNemar|||Deferasirox DT vs previous iron chelation therapy at Week 24||0.72|0.44|< 0.0001
71680265|NCT03051516|142878421|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm I (Vaccine)||||0.73
71821267|NCT02718417|143144857|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.8953|TWO_SIDED|95.0|0.776|3.111||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.||||3.111|0.776|0.8953
71821268|NCT02718417|143144858|OTHER||Hazard Ratio (HR)|1.21||||0.9278|TWO_SIDED|95.0|0.935|1.578||One-sided log-rank test was used.|Log Rank|||||1.578|0.935|0.9278
71821269|NCT02718417|143144858|OTHER||Hazard Ratio (HR)|0.9||||0.2367|TWO_SIDED|95.0|0.688|1.189||One-sided log-rank test was used.|Log Rank|||||1.189|0.688|0.2367
71821270|NCT02451930|143144906|OTHER|||||||0.4491|||||||Fisher Exact|||||||0.4491
71821271|NCT00906503|143144964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3|STANDARD_DEVIATION|1.6|||TWO_SIDED|95.0|0.06|31.1||||||||31.1|0.06|
71821272|NCT00684983|143144982|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.89|TWO_SIDED|95.0|0.58|1.89|||Regression, Cox|||Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.||1.89|0.58|.89
71852885|NCT00141271|143219586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7077||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7077
71852886|NCT00141271|143219587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5057||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.5057
71852887|NCT00141271|143219587|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.3654
71903053|NCT02993224|143327879|SUPERIORITY||Least squares mean|-3.6|STANDARD_ERROR_OF_MEAN|2.3||0.1191|TWO_SIDED|95.0|-8.1|0.9|||ANCOVA|||Compliance of deferasirox DT vs deferasirox FCT||0.9|-8.1|0.1191
71903054|NCT02915367|143327897|OTHER|Pearson chi-square||||||0.93|||||||Chi-squared|||||||0.93
71903055|NCT02915367|143327899|OTHER|Pearson chi-square||||||0.96|||||||Chi-squared|||||||0.96
71903056|NCT00952289|143327907|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|||The primary endpoint analyzed with a 2-sided alpha of 0.05.||||<0.0001
71680266|NCT03051516|142878421|SUPERIORITY|||||||0.998|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm I (Vaccine)||||0.998
71852888|NCT00141271|143219588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6227||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.6227
71852889|NCT00141271|143219588|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7737||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint||||0.7737
71852890|NCT01044901|143219633|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
71852891|NCT01044901|143219634|OTHER||||||<|0.0001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney test).||||<0.0001
71852892|NCT01044901|143219635|OTHER|||||||0.0137|||||||t-test, 2 sided|P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0137
71852893|NCT01044901|143219636|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
71852894|NCT01044901|143219637|OTHER|||||||0.16||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.16
71852895|NCT01044901|143219638|OTHER|||||||0.0039||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.0039
71852896|NCT01044901|143219639|OTHER|||||||0.0011||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0011
71903057|NCT00958308|143327927|SUPERIORITY_OR_OTHER||||||=|0.02|||||||Fisher Exact|||The sample size calculation was based on the incidence of AAD. A total of 255 patients was enrolled in order to obtain at least the required 225 evaluable patients.With expected AAD rates of at most 15% - 25% in the treatment groups; and 25% - 35% in the placebo group, these numbers were sufficient to detect the difference in the incidence of AAD between either of the treatment groups vs. placebo with a minimum of 86% statistical power.||||=0.02
71903058|NCT02227329|143327934|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71680267|NCT03051516|142878421|SUPERIORITY|||||||0.93|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm I (Vaccine)||||0.93
71680268|NCT03051516|142878421|SUPERIORITY|||||||0.95|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm I (Vaccine)||||0.95
71821273|NCT00684983|143144983|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.93|TWO_SIDED|95.0|0.5|3.0|||Log Rank|||||3|0.5|0.93
71821274|NCT00684983|143144984|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.66|TWO_SIDED|95.0|0.53|1.92|||Log Rank|||||1.92|.53|.66
71821275|NCT00684983|143144986|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.26|TWO_SIDED|95.0|0.09|1.53|||Log Rank|||||1.53|.09|.26
71821276|NCT04496167|143144992|OTHER||Least Square Mean Treatment Difference|1.386||||0.659|TWO_SIDED|95.0|-4.804|7.577||Considered significant if p-value is less than 0.05.|MMRM||"The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.~Treatment difference: EN3835 - Placebo"|Mixed Model Repeated Measures (MMRM) was performed to estimate the change from Baseline treatment effect of the adapted ASES composite score in the affected shoulder comparing EN3835 to placebo treatment.||7.577|-4.804|0.659
71821277|NCT03088137|143145041|EQUIVALENCE|Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.|Mean Difference (Final Values)|0.546|STANDARD_DEVIATION|1.297||0.002|TWO_SIDED|95.0|-2.026|3.116|||Wilcoxon (Mann-Whitney)|||||3.116|-2.026|0.002
71821278|NCT03088137|143145042|SUPERIORITY||Mean Difference (Final Values)|0.709|STANDARD_DEVIATION|1.067||0.806|TWO_SIDED|95.0|-1.405|2.824|||Wilcoxon (Mann-Whitney)|||||2.824|-1.405|0.806
71821279|NCT03088137|143145043|SUPERIORITY||Mean Difference (Final Values)|0.218|STANDARD_DEVIATION|1.129||0.617|TWO_SIDED|95.0|-2.455|2.019|||Wilcoxon (Mann-Whitney)|||||2.019|-2.455|0.617
71821280|NCT03088137|143145044|SUPERIORITY||Mean Difference (Final Values)|0.636|STANDARD_DEVIATION|1.19||0.445|TWO_SIDED|95.0|-2.995|1.723|||Wilcoxon (Mann-Whitney)|||||1.723|-2.995|0.445
71821281|NCT03088137|143145045|SUPERIORITY|||||||0.623|||||||ANOVA|||||||0.623
71821282|NCT03088137|143145046|SUPERIORITY||Mean Difference (Final Values)|14.9|STANDARD_DEVIATION|49.8||0.488|TWO_SIDED|95.0|-83.9|113.6|||Wilcoxon (Mann-Whitney)|||||113.6|-83.9|0.488
71821283|NCT03088137|143145047|SUPERIORITY||Mean Difference (Final Values)|0.018|STANDARD_DEVIATION|0.201||0.629|TWO_SIDED|95.0|-0.379|0.416|||Wilcoxon (Mann-Whitney)|||||0.416|-0.379|0.629
71852897|NCT01044901|143219640|OTHER|||||||0.1||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.10
71852898|NCT01044901|143219641|OTHER|||||||0.48||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.48
71852899|NCT01044901|143219642|OTHER|||||||0.08||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.08
71852900|NCT01044901|143219643|OTHER|||||||0.91||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.91
71852901|NCT01044901|143219644|OTHER|||||||0.0038||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0038
71852902|NCT01044901|143219645|OTHER|||||||0.034||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.034
71852903|NCT01044901|143219646|OTHER|||||||0.25||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Fisher Exact|||Primary outcome was presented was as frequencies and percentages, and then analyzed with a Fisher exact test.||||0.25
71852904|NCT01044901|143219647|OTHER|||||||0.0288||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.0288
71852905|NCT01044901|143219648|OTHER|||||||0.14||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|Wilcoxon (Mann-Whitney)|||Primary outcome was presented at baseline as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon (Mann-Whitney) test.||||0.14
71852906|NCT01044901|143219649|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.13
71852907|NCT01044901|143219650|OTHER|||||||0.81||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.81
71852908|NCT01044901|143219651|OTHER|||||||0.3||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05.|t-test, 2 sided|||Primary outcome was presented at baseline as mean +/- standard deviation based upon the Shapiro-Wilks test of normality, and then analyzed with a Student t-test.||||0.30
71852909|NCT02878590|143219658|SUPERIORITY|||||||0.0093|||||||t-test, 2 sided|||||||0.0093
71852910|NCT03149887|143219659|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71852911|NCT03149887|143219660|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71852912|NCT03149887|143219661|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71852913|NCT03149887|143219662|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71852914|NCT03149887|143219663|SUPERIORITY|||||||0.53|||||||t-test, 2 sided|||||||0.53
71852915|NCT03149887|143219664|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71852916|NCT03149887|143219665|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||0.76
71852917|NCT03149887|143219666|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.44
71852918|NCT00116584|143219698|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71852919|NCT00116584|143219699|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71852920|NCT00116584|143219700|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71852921|NCT03034772|143219701|SUPERIORITY|||||||0.04|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.04
71852922|NCT03034772|143219702|SUPERIORITY|||||||0.11|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.11
71852923|NCT03034772|143219703|SUPERIORITY|||||||0.01|||||||ANCOVA|Mean difference between the 2 groups derived using analysis of covariance, with the baseline value and type of anti-VEGF drug used as covariates.||||||0.01
71852924|NCT03034772|143219704|SUPERIORITY|||||||0.78|||||||ANCOVA|||||||0.78
71852925|NCT03034772|143219705|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.24
71852926|NCT01533181|143219768|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.9||||0.0001|TWO_SIDED|95.0|1.9|8.1|||Kaplan-Meier|||||8.1|1.9|0.0001
71852927|NCT01533181|143219771|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.71|TWO_SIDED|95.0|0.6|2.2|||Kaplan-Meier|||||2.2|0.6|0.71
71852928|NCT01837719|143219780|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (fixed-dose combination \[FDC\] tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC\[0-T\]) and AUC from time 0 to infinity. (AUC\[0-T\])|Geometric mean ratio|1.073|||||TWO_SIDED|90.0|1.012|1.137|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax, with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.137|1.012|
71680269|NCT03051516|142878421|SUPERIORITY|||||||0.91|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm I (Vaccine)||||0.91
71680270|NCT03051516|142878421|SUPERIORITY|||||||0.22|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV16, in Arm II (Placebo)||||0.22
71680271|NCT03051516|142878421|SUPERIORITY|||||||0.27|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV18, in Arm II (Placebo)||||0.27
71680272|NCT03051516|142878421|SUPERIORITY|||||||0.72|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV31, in Arm II (Placebo)||||0.72
71680273|NCT03051516|142878421|SUPERIORITY|||||||0.71|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV33, in Arm II (Placebo)||||0.71
71680274|NCT03051516|142878421|SUPERIORITY|||||||0.11|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV45, in Arm II (Placebo)||||0.11
71821284|NCT03088137|143145048|SUPERIORITY|||||||0.644|||||||Wilcoxon (Mann-Whitney)|||||||0.644
71821285|NCT03088137|143145051|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.833|TWO_SIDED|95.0|-21.0|17.0|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||17.0|-21.0|0.833
71821286|NCT03088137|143145052|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.507|TWO_SIDED|95.0|-24.3|11.9|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.||11.9|-24.3|0.507
71821287|NCT00918749|143145062|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.598|STANDARD_ERROR_OF_MEAN|4.215||0.3946|TWO_SIDED|90.0|-10.568|3.372|||ANOVA|Fixed effects for treatment and center.||A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.||3.372|-10.568|0.3946
71680275|NCT03051516|142878421|SUPERIORITY|||||||0.58|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV52, in Arm II (Placebo)||||0.58
71821288|NCT00918749|143145062|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.197|STANDARD_ERROR_OF_MEAN|4.241||0.0045|TWO_SIDED|90.0|-19.208|-5.185|||ANOVA|Fixed effects for treatment and center.||||-5.185|-19.208|0.0045
71852929|NCT01837719|143219780|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.423|||||TWO_SIDED|90.0|1.273|1.59|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.590|1.273|
71852930|NCT01837719|143219780|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.137|||||TWO_SIDED|90.0|1.0|1.292|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.292|1.000|
71680276|NCT03051516|142878421|SUPERIORITY|||||||0.81|||||||Log Rank|||This p-value compares HSIL recurrence and presence of HPV58, in Arm II (Placebo)||||0.81
71680277|NCT03051516|142878421|SUPERIORITY|||||||0.73|||||||Log Rank|||This p-value compares HSIL recurrence and presence of any HPV type, in Arm II (Placebo)||||0.73
71680278|NCT02339155|142878425|NON_INFERIORITY|If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.|Ratio|1.18||||0.0016|TWO_SIDED|90.0|1.03|1.35|||t-test, 1 sided|||||1.35|1.03|0.0016
71821289|NCT00918749|143145063|SUPERIORITY_OR_OTHER||LS Mean Difference|4.765|STANDARD_ERROR_OF_MEAN|4.952||0.3372|TWO_SIDED|90.0|-3.421|12.952|||ANOVA|Fixed effects for treatment and center.||||12.952|-3.421|0.3372
71821290|NCT00918749|143145063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.218|STANDARD_ERROR_OF_MEAN|4.966||0.965|TWO_SIDED|90.0|-8.427|7.991|||ANOVA|Fixed effects for treatment and center.||||7.991|-8.427|0.9650
71680279|NCT02339155|142878426|OTHER||Ratio|1.09|||||TWO_SIDED|90.0|0.98|1.22|||t-test, 1 sided||Week 8|||1.22|0.98|
71680280|NCT02339155|142878426|OTHER||Ratio|0.98|||<|0.0001|TWO_SIDED|90.0|0.89|1.07|||t-test, 1 sided||Week 26|||1.07|0.89|<0.0001
71680281|NCT02634268|142878503|SUPERIORITY||Mean Difference (Final Values)|42.3||||0.02|TWO_SIDED|95.0|7.93|76.6|||Mixed Models Analysis|Difference in average six minute walk test distance at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||76.6|7.93|.02
71680282|NCT02634268|142878504|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0008|TWO_SIDED|95.0|-0.63|-0.09|||Mixed Models Analysis|Difference in average Modified Borg Scale score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.09|-0.63|.0008
71680283|NCT02634268|142878505|SUPERIORITY||Mean Difference (Final Values)|-1.34||||0.0008|TWO_SIDED|95.0|-2.33|-0.34|||Mixed Models Analysis|Difference in average body weight at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.34|-2.33|0.0008
71821291|NCT00918749|143145064|SUPERIORITY_OR_OTHER||LS Mean Difference|0.388|STANDARD_ERROR_OF_MEAN|4.269||0.9276|TWO_SIDED|90.0|-6.67|7.447|||ANOVA|Fixed effects for treatment and center.||||7.447|-6.670|0.9276
71688688|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.19|0.37|||t-test, 2 sided|||FVC Day 8 (-0.25 hrs post-dose)||0.37|0.19|<0.0001
71821292|NCT00918749|143145064|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.787|STANDARD_ERROR_OF_MEAN|4.313||0.0133|TWO_SIDED|90.0|-17.917|-3.657|||ANOVA|Fixed effects for treatment and center.||||-3.657|-17.917|0.0133
71821293|NCT00918749|143145065|SUPERIORITY_OR_OTHER||LS Mean Difference|14.528|STANDARD_ERROR_OF_MEAN|9.28||0.1192|TWO_SIDED|90.0|-0.813|29.868|||ANOVA|Fixed effects for treatment and center.||||29.868|-0.813|0.1192
71821294|NCT00918749|143145065|SUPERIORITY_OR_OTHER||LS Mean Difference|14.215|STANDARD_ERROR_OF_MEAN|9.343||0.1298|TWO_SIDED|90.0|-1.23|29.659|||ANOVA|Fixed effects for treatment and center.||||29.659|-1.230|0.1298
71821295|NCT00918749|143145066|SUPERIORITY_OR_OTHER||LS Mean Difference|1.119|STANDARD_ERROR_OF_MEAN|6.093||0.8546|TWO_SIDED|90.0|-8.956|11.193|||ANOVA|Fixed effects for treatment and center.||||11.193|-8.956|0.8546
71821296|NCT00918749|143145066|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.393|STANDARD_ERROR_OF_MEAN|6.126||0.2291|TWO_SIDED|90.0|-17.522|2.737|||ANOVA|Fixed effects for treatment and center.||||2.737|-17.522|0.2291
71852931|NCT01837719|143219780|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.862|||||TWO_SIDED|90.0|0.701|1.059|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.059|0.701|
71852932|NCT01837719|143219780|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.643|||||TWO_SIDED|90.0|0.545|0.759|||Mixed Models Analysis||Geometric mean ratio is calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.759|0.545|
71852933|NCT01837719|143219781|NON_INFERIORITY_OR_EQUIVALENCE|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|Geometric mean ratio|1.065|||||TWO_SIDED|90.0|1.012|1.12|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment B/Treatment A|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).||1.120|1.012|
71852934|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.275|||||TWO_SIDED|90.0|1.166|1.393|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as a random effect was used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.393|1.166|
71852935|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.113|||||TWO_SIDED|90.0|0.993|1.248|||Mixed Models Analysis||Geometric mean ratio for AUC(0-T) is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.248|0.993|
71852936|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|90.0|0.804|1.122|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC.||1.122|0.804|
71852937|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.746|||||TWO_SIDED|90.0|0.655|0.849|||Mixed Models Analysis||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC||0.849|0.655|
71903059|NCT03492463|143327964|SUPERIORITY|||||||0.01|||||||Regression, Linear|||Due to time and budget constraints a blinded decision was made and approved by the funding agency to limit further enrollment to the two conditions that provided nicotine patches. The primary (one-tailed) test compared Nicotine e-cigs + Nicotine patches to Non-nicotine e-cigs + Nicotine patches.||||0.01
71903060|NCT03492463|143327965|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
71903061|NCT03492463|143327966|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
71903062|NCT00488618|143327968|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.9|-3.3|||ANCOVA||cariprazine - placebo|||-3.3|-8.9|<0.0001
71821297|NCT00918749|143145067|SUPERIORITY_OR_OTHER||LS Mean Difference|5.505|STANDARD_ERROR_OF_MEAN|9.046||0.5436|TWO_SIDED|90.0|-9.452|20.462|||ANOVA|Fixed effects for treatment and center.||||20.462|-9.452|0.5436
71821298|NCT00918749|143145067|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.914|STANDARD_ERROR_OF_MEAN|9.1||0.9201|TWO_SIDED|90.0|-15.959|14.132|||ANOVA|Fixed effects for treatment and center.||||14.132|-15.959|0.9201
71821299|NCT00918749|143145068|SUPERIORITY_OR_OTHER||LS Mean Difference|3.108|STANDARD_ERROR_OF_MEAN|4.052||0.444|TWO_SIDED|90.0|-3.59|9.807|||ANOVA|Fixed effects for treatment and center.||||9.807|-3.590|0.4440
71821300|NCT00918749|143145068|SUPERIORITY_OR_OTHER||LS Mean Difference|4.842|STANDARD_ERROR_OF_MEAN|4.063||0.2349|TWO_SIDED|90.0|-1.874|11.559|||ANOVA|Fixed effects for treatment and center.||||11.559|-1.874|0.2349
71821301|NCT00918749|143145069|SUPERIORITY_OR_OTHER||LS Mean Difference|4.966|STANDARD_ERROR_OF_MEAN|4.327||0.2527|TWO_SIDED|90.0|-2.189|12.12|||ANOVA|Fixed effects for treatment and center.||||12.120|-2.189|0.2527
71903063|NCT00488618|143327969|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64||||0.0001|TWO_SIDED|95.0|-0.97|-0.32|||ANCOVA||cariprazine - placebo|||-0.32|-0.97|0.0001
71903064|NCT03675737|143327975|SUPERIORITY||Hazard Ratio (HR)|0.78|||<|0.0001|TWO_SIDED|95.0|0.7|0.87||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.87|0.70|<0.0001
71903065|NCT03675737|143327976|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001|TWO_SIDED|95.0|0.65|0.84||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.84|0.65|<0.0001
71903066|NCT03675737|143327977|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.53|0.79||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.79|0.53|<0.0001
71903067|NCT03675737|143327978|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.0001|TWO_SIDED|95.0|0.67|0.85||One-sided p-value based on log-rank test stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||0.85|0.67|<0.0001
71680284|NCT02634268|142878506|SUPERIORITY||Mean Difference (Final Values)|1.48||||0.01|TWO_SIDED|95.0|0.35|2.6|||Mixed Models Analysis|Difference in average SF-12 PCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||2.60|0.35|0.01
71821302|NCT00918749|143145069|SUPERIORITY_OR_OTHER||LS Mean Difference|4.926|STANDARD_ERROR_OF_MEAN|4.371||0.2613|TWO_SIDED|90.0|-2.301|12.153|||ANOVA|Fixed effects for treatment and center.||||12.153|-2.301|0.2613
71821303|NCT00918749|143145070|SUPERIORITY_OR_OTHER||LS Mean Difference|1.269|STANDARD_ERROR_OF_MEAN|4.16||0.7606|TWO_SIDED|90.0|-5.609|8.148|||ANOVA|Fixed effects for treatment and center.||||8.148|-5.609|0.7606
71821304|NCT00918749|143145070|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.825|STANDARD_ERROR_OF_MEAN|4.185||0.5006|TWO_SIDED|90.0|-9.744|4.095|||ANOVA|Fixed effects for treatment and center.||||4.095|-9.744|0.5006
71821305|NCT03055832|143145106|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-3.82|3.56||||||||3.56|-3.82|
71852938|NCT01837719|143219781|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|Geometric mean ratio|1.064||||||90.0|1.011|1.12|||Mixed Models Analysis||Geometric mean ration for AUC(INF) is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment period and sequence as fixed effects, and patient (sequence) as a random effect.||1.120|1.011|
71852939|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.28|||||TWO_SIDED|90.0|1.171|1.398|||Mixed Models Analysis||Geometric mean ratio for AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of a light meal and fthe fasted state on the natural logarithms of exposure of atazanavir when given as an FDC||1.398|1.171|
71852940|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.11|||||TWO_SIDED|90.0|0.991|1.244|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect||1.244|0.991|
71852941|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.956|||||TWO_SIDED|90.0|0.81|1.128|||Mixed Models Analysis||Geometric mean of AUC(INF) was calculated as Treatment E/Treatment D|||1.128|0.810|
71903068|NCT03675737|143327979|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.63|0.82||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.82|0.63|<0.0001
71903069|NCT03675737|143327980|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.76||One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.|||0.76|0.51|<0.0001
71903070|NCT03675737|143327981|SUPERIORITY||Difference in Percentage|9.3||||9e-05|TWO_SIDED|95.0|4.4|14.1||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region, Programmed Cell Death Ligand 1 (PD-L1) status (Combined Positive Score \[CPS\] \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region, PD-L1 status (CPS \<1 versus CPS ≥1), and chemotherapy regimen with small strata collapsed.|||14.1|4.4|0.00009
71821306|NCT03055832|143145107|NON_INFERIORITY|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~* MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~* TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~* Power that both endpoitns are significant, assuming independence was 0.939\^2 = 0.882 or 88.2% power."|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-0.97|1.16||||||||1.16|-0.97|
71821307|NCT03055832|143145108|OTHER|A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.||||||0.12|||||||Fisher Exact|||||||0.12
71821308|NCT03055832|143145109|NON_INFERIORITY|A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint|Mean Difference (Net)|-3.08|STANDARD_ERROR_OF_MEAN|2.89|||TWO_SIDED|95.0|-8.75|2.59||||||All questions||2.59|-8.75|
71821309|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.011||||90.0|-0.064|-0.026|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M3||-0.026|-0.064|
71821310|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.025|0.02|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.020|-0.025|
71821311|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.033|0.013|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M9||0.013|-0.033|
71821312|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.014||||90.0|-0.044|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||0.004|-0.044|
71821313|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.015||||90.0|-0.048|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M15||0.003|-0.048|
71821314|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.016||||90.0|-0.05|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M18||0.004|-0.050|
71821315|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.047|0.007|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M21||0.007|-0.047|
71821316|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.054|0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.002|-0.054|
71821317|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.021|0.034|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.034|-0.021|
71821318|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.018||||90.0|-0.016|0.044|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.044|-0.016|
71821319|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.017||||90.0|-0.002|0.055|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.055|-0.002|
71821320|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.022||||90.0|-0.04|0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.032|-0.040|
71903071|NCT03675737|143327982|SUPERIORITY||Difference in Percentage|9.5||||0.00041|TWO_SIDED|95.0|3.9|15.0||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||15.0|3.9|0.00041
71903072|NCT03675737|143327983|SUPERIORITY||Difference in Percentage|17.5||||2e-05|TWO_SIDED|95.0|9.3|25.5||One-sided p-value based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by geographic region and chemotherapy regimen with small strata collapsed.|||25.5|9.3|0.00002
71903073|NCT02922634|143328018|SUPERIORITY|||||||0.508|||||||Wilcoxon (Mann-Whitney)|||||||0.508
71903074|NCT02922634|143328019|SUPERIORITY|||||||0.72||||||The chi-squared test for both males and females with and without delirium.|Chi-squared|||||||0.720
71903075|NCT02922634|143328020|SUPERIORITY|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
71903076|NCT02922634|143328021|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.480
71821321|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.07|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.004|-0.070|
71903077|NCT02922634|143328022|SUPERIORITY|||||||0.028|||||||Chi-squared|||||||0.028
71903078|NCT02922634|143328023|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
71903079|NCT02922634|143328024|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71903080|NCT02922634|143328025|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71903081|NCT02922634|143328026|SUPERIORITY|||||||0.101|||||||Chi-squared|||||||0.101
71903082|NCT02922634|143328027|SUPERIORITY|||||||0.192|||||||Chi-squared|||||||0.192
71903083|NCT02922634|143328028|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.200
71903084|NCT02922634|143328029|SUPERIORITY|||||||0.333|||||||Wilcoxon (Mann-Whitney)|||||||0.333
71903085|NCT02922634|143328030|SUPERIORITY|||||||0.001||||||This is a chi-squared test between the FRAIL categories for participants with or without delirium.|Chi-squared|||||||0.001
71903086|NCT02922634|143328031|SUPERIORITY|||||||0.002||||||This is a chi-squared test of the categories for levels of invasiveness for participants with or without delirium.|Chi-squared|||||||0.002
71903087|NCT01694420|143328076|SUPERIORITY_OR_OTHER||||||<|0.001||||||Study data compared to data as cited in PubMed ID: 21487250|Wilcoxon (Mann-Whitney)|||||||<0.001
71903088|NCT03987919|143328079|SUPERIORITY||LS Mean Difference|-0.51|||<|0.001|TWO_SIDED|95.0|-0.64|-0.38|||Mixed Models Analysis|||||-0.38|-0.64|<0.001
71903089|NCT03987919|143328079|SUPERIORITY||LS Mean Difference|-0.6|||<|0.001|TWO_SIDED|95.0|-0.73|-0.47|||Mixed Models Analysis|||||-0.47|-0.73|<0.001
71903090|NCT03987919|143328080|SUPERIORITY||LS Mean Difference|-0.23|||<|0.001|TWO_SIDED|95.0|-0.36|-0.1|||Mixed Models Analysis|||||-0.10|-0.36|<0.001
71903091|NCT03987919|143328081|SUPERIORITY||LS Mean Difference|-1.7|||<|0.001|TWO_SIDED|95.0|-2.6|-0.7|||Mixed Models Analysis|||||-0.7|-2.6|<0.001
71903092|NCT03987919|143328081|SUPERIORITY||LS Mean Difference|-4.1|||<|0.001|TWO_SIDED|95.0|-5.0|-3.2|||Mixed Models Analysis|||||-3.2|-5.0|<0.001
71903093|NCT03987919|143328081|SUPERIORITY||LS Mean Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-7.1|-5.3|||Mixed Models Analysis|||||-5.3|-7.1|<0.001
71903094|NCT03987919|143328082|SUPERIORITY||Odds Ratio (OR)|1.54||||0.023|TWO_SIDED|95.0|1.06|2.23|||Regression, Logistic|||||2.23|1.06|0.023
71903095|NCT03987919|143328082|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.44|3.17|||Regression, Logistic|||||3.17|1.44|<0.001
71903096|NCT03987919|143328082|SUPERIORITY||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|1.97|4.66|||Regression, Logistic|||||4.66|1.97|<0.001
71903097|NCT03987919|143328083|SUPERIORITY||LS Mean Difference|-7.3||||0.001|TWO_SIDED|95.0|-11.7|-3.0|||Mixed Models Analysis|||||-3.0|-11.7|0.001
71903098|NCT03987919|143328083|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-17.4|-8.6|||Mixed Models Analysis|||||-8.6|-17.4|<0.001
71903099|NCT03987919|143328083|SUPERIORITY||LS Mean Difference|-14.7|||<|0.001|TWO_SIDED|95.0|-19.1|-10.3|||Mixed Models Analysis|||||-10.3|-19.1|<0.001
71903100|NCT03987919|143328085|SUPERIORITY||Odds Ratio (OR)|1.58||||0.001|TWO_SIDED|95.0|1.2|2.08|||Regression, Logistic|||||2.08|1.20|0.001
71821322|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.077|-0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||-0.002|-0.077|
71903101|NCT03987919|143328085|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|2.57|4.75|||Regression, Logistic|||||4.75|2.57|<0.001
71903102|NCT03987919|143328085|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|3.32|6.38|||Regression, Logistic|||||6.38|3.32|<0.001
71821323|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M9||0.003|-0.075|
71903103|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.24||||0.084|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Hyperglycemia||0.03|-0.50|0.084
71903104|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.27||||0.05|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Hyperglycemia||0.00|-0.54|0.050
71903105|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.39||||0.005|TWO_SIDED|95.0|-0.66|-0.12|||ANCOVA|||Hyperglycemia||-0.12|-0.66|0.005
71903106|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.06||||0.688|TWO_SIDED|95.0|-0.33|0.22|||ANCOVA|||Hypoglycemia||0.22|-0.33|0.688
71903107|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.02||||0.909|TWO_SIDED|95.0|-0.29|0.26|||ANCOVA|||Hypoglycemia||0.26|-0.29|0.909
71903108|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.13||||0.358|TWO_SIDED|95.0|-0.4|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.40|0.358
71903109|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.1||||0.701|TWO_SIDED|95.0|-0.62|0.41|||ANCOVA|||Total Score||0.41|-0.62|0.701
71903110|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|-0.25||||0.341|TWO_SIDED|95.0|-0.78|0.27|||ANCOVA|||Total Score||0.27|-0.78|0.341
71903111|NCT03987919|143328086|SUPERIORITY||LS Mean Difference|0.26||||0.321|TWO_SIDED|95.0|-0.26|0.79|||ANCOVA|||Total Score||0.79|-0.26|0.321
71903112|NCT03987919|143328088|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.001|TWO_SIDED|95.0|1.35|2.57|||Regression, Logistic|||||2.57|1.35|<0.001
71903113|NCT03987919|143328088|SUPERIORITY||Odds Ratio (OR)|3.94|||<|0.001|TWO_SIDED|95.0|2.88|5.39|||Regression, Logistic|||||5.39|2.88|<0.001
71903114|NCT03987919|143328088|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|3.73|6.97|||Regression, Logistic|||||6.97|3.73|<0.001
71903115|NCT01194804|143328089|OTHER||||||<|0.001|||||||Sign test|||||||<0.001
71903116|NCT03621943|143328094|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.87|TWO_SIDED|95.0|-6.36|5.37|||hierarchical generalized linear mixed mo|hierarchical generalized linear mixed models||Total score on the Ages and Stages Questionnaire, 3rd ed.||5.37|-6.36|0.87
71903117|NCT00948818|143328119|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.6||||0.0004|TWO_SIDED|95.0|1.51|4.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||4.47|1.51|0.0004
71903118|NCT00948818|143328121|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.65|||<|0.0001|TWO_SIDED|95.0|2.26|5.88||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||5.88|2.26|<0.0001
71903119|NCT00948818|143328122|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0262|TWO_SIDED|95.0|1.04|1.91||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."||1.91|1.04|0.0262
71903120|NCT00948818|143328123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.0001|TWO_SIDED|95.0|1.4|2.66||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||2.66|1.40|<0.0001
71903121|NCT02330549|143328133|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.2286|STANDARD_ERROR_OF_MEAN|0.195||0.2483|TWO_SIDED|95.0|-0.62|0.17||An analysis of covariance (ANCOVA) model that included treatment and presence or absence of nonalcoholic steatohepatitis (NASH) as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||0.17|-0.62|0.2483
71903122|NCT02330549|143328133|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.4113|STANDARD_ERROR_OF_MEAN|0.205||0.053|TWO_SIDED|95.0|-0.83|0.01||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change form Baseline to Week 24||0.01|-0.83|0.053
71903123|NCT02330549|143328134|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-1.505|STANDARD_ERROR_OF_MEAN|2.369||0.5297|TWO_SIDED|95.0|-6.33|3.32||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12||3.32|-6.33|0.5297
71903124|NCT02330549|143328134|OTHER|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|3.2146|STANDARD_ERROR_OF_MEAN|2.757||0.2522|TWO_SIDED|95.0|-2.4|8.83||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 24||8.83|-2.4|0.2522
71903125|NCT00797797|143328210|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.||||<0.001
71903126|NCT00797797|143328211|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-14.35|||||TWO_SIDED|95.0|-18.99|-9.71|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-9.71|-18.99|
71903127|NCT01575197|143328212|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||||||0.014
71903128|NCT01575197|143328213|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Fisher Exact|||||||0.16
71903129|NCT01575197|143328214|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||t-test, 2 sided|||||||0.038
71903130|NCT01575197|143328215|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
71903131|NCT02371759|143328297|NON_INFERIORITY_OR_EQUIVALENCE|In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group||||<0.05
71903132|NCT02371759|143328298|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903133|NCT02371759|143328314|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903134|NCT02371759|143328315|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903135|NCT02371759|143328316|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903136|NCT02371759|143328317|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903137|NCT02371759|143328318|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71903138|NCT02371759|143328319|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71903139|NCT02371759|143328320|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903140|NCT02371759|143328321|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71903141|NCT00430625|143328322|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.429|STANDARD_ERROR_OF_MEAN|0.324|<|0.0001|TWO_SIDED|95.0|1.717|3.141|||paired t-test|||Primary endpoint was based solely on the 60 U/kg treatment arm||3.141|1.717|<0.0001
71903142|NCT00243230|143328329|SUPERIORITY||VCV 30 mg vs. Placebo|-0.98||||0.0017|TWO_SIDED|95.0|-1.58|-0.37|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.37|-1.58|0.0017
71903143|NCT00243230|143328329|SUPERIORITY||VCV 20 mg vs. Placebo|-0.93||||0.0026||95.0|-1.54|-0.33|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.33|-1.54|0.0026
71903144|NCT00243230|143328330|SUPERIORITY|||||||0.0052|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0052
71903145|NCT00243230|143328330|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0190
71903146|NCT00243230|143328331|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0007
71903147|NCT00243230|143328331|SUPERIORITY|||||||0.0028|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0028
71903148|NCT00243230|143328333|SUPERIORITY||Vicriviroc 30mg - Placebo|-1.0||||0.0002|TWO_SIDED|95.0|-1.53|-0.48|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.48|-1.53|0.0002
71903149|NCT00243230|143328333|SUPERIORITY||Vicriviroc 20 mg - Placebo|-0.84||||0.002|TWO_SIDED|95.0|-1.36|-0.31|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||-0.31|-1.36|0.0020
71903150|NCT00243230|143328334|SUPERIORITY||Vicriviroc 30 mg - Placebo|-1.1||||0.0003|TWO_SIDED|95.0|-1.69|-0.51|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.51|-1.69|0.0003
71903151|NCT00243230|143328334|SUPERIORITY||Vicriviroc 20 mg - Placebo|-1.07||||0.0004|TWO_SIDED|95.0|-1.66|-0.49|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA \<=100,000 copies/mL.||||-0.49|-1.66|0.0004
71903152|NCT00243230|143328335|SUPERIORITY||VCV 30 mg - Placebo|57.76||||0.0264|TWO_SIDED|95.0|6.9|108.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||108.61|6.90|0.0264
71903153|NCT00243230|143328335|SUPERIORITY||VCV 20 mg - Placebo|42.36||||0.102|TWO_SIDED|95.0|-8.55|93.28|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||93.28|-8.55|0.1020
71903154|NCT00243230|143328336|SUPERIORITY||VCV 30 mg - Placebo|38.12||||0.1525|TWO_SIDED|95.0|-14.32|90.56|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||90.56|-14.32|0.1525
71903155|NCT00243230|143328336|SUPERIORITY||VCV 20 mg - Placebo|44.12||||0.0987|TWO_SIDED|95.0|-8.38|96.61|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||96.61|-8.38|0.0987
71821324|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.058|0.022|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.022|-0.058|
71903156|NCT00243230|143328337|SUPERIORITY||VCV 30 mg - Placebo|37.32||||0.2603|TWO_SIDED|95.0|-28.05|102.68|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||102.68|-28.05|0.2603
71903157|NCT00243230|143328337|SUPERIORITY||VCV 20 mg - Placebo|69.08||||0.0387|TWO_SIDED|95.0|3.64|134.52|||ANOVA|ANOVA model adjusted for treatment and stratification factors - the use of T20 in current OBT and the baseline HIV-1 RNA ≤100,000 copies/mL.||||134.52|3.64|0.0387
71903158|NCT00243230|143328339|SUPERIORITY|||||||0.0031|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0031
71903159|NCT00243230|143328339|SUPERIORITY|||||||0.048|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0480
71903160|NCT00243230|143328340|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
71903161|NCT00243230|143328340|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
71903162|NCT00243230|143328342|SUPERIORITY|||||||0.0225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0225
71903163|NCT00243230|143328342|SUPERIORITY|||||||0.0582|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0582
71903164|NCT00243230|143328343|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0009
71821325|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.034|0.048|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M15||0.048|-0.034|
71903165|NCT00243230|143328343|SUPERIORITY|||||||0.0038|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0038
71903166|NCT00243230|143328344|SUPERIORITY|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0002
71903167|NCT00243230|143328344|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Test adjusted for stratification factors of T20 use in current OBT and baseline HIV-1 RNA.||||||0.0004
71903168|NCT01515306|143328396|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|1.09|||||TWO_SIDED|90.0|0.93|1.29|||Mixed Models Analysis|Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.||||1.29|0.93|
71903169|NCT01515306|143328398|SUPERIORITY_OR_OTHER_LEGACY||Ratio of Geo LS means|0.97|||||TWO_SIDED|90.0|0.83|1.13|||Mixed Models Analysis|Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.||||1.13|0.83|
71903170|NCT03855137|143328415|SUPERIORITY||Least Squares Mean Difference|-2.41|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.48|-1.33||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Mixed Model Repeated Measures (MMRM)||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.33|-3.48|0.0001
71903171|NCT03855137|143328415|SUPERIORITY||Least Squares Mean Difference|-1.82|STANDARD_ERROR_OF_MEAN|0.545||0.0009|TWO_SIDED|95.0|-2.89|-0.75||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.75|-2.89|0.0009
71903172|NCT03855137|143328416|SUPERIORITY||Least Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|0.547||0.0001|TWO_SIDED|95.0|-3.31|-1.16||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.16|-3.31|0.0001
71903173|NCT03855137|143328416|SUPERIORITY||Least Squares Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.544||0.0024|TWO_SIDED|95.0|-2.72|-0.59|||MMRM|Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.59|-2.72|0.0024
71903174|NCT03855137|143328417|SUPERIORITY||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.541||0.0001|TWO_SIDED|95.0|-3.38|-1.26||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.26|-3.38|0.0001
71903175|NCT03855137|143328417|SUPERIORITY||Least Squares Mean Difference|-1.87|STANDARD_ERROR_OF_MEAN|0.538||0.0009|TWO_SIDED|95.0|-2.93|-0.81||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.81|-2.93|0.0009
71903176|NCT03855137|143328418|SUPERIORITY||Least Squares Mean Difference|-2.14|STANDARD_ERROR_OF_MEAN|0.539||0.0002|TWO_SIDED|95.0|-3.2|-1.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.09|-3.20|0.0002
71903177|NCT03855137|143328418|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|0.536||0.0024|TWO_SIDED|95.0|-2.78|-0.67||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.67|-2.78|0.0024
71903178|NCT03855137|143328419|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-3.63|-1.63||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.63|-3.63|0.0001
71903179|NCT03855137|143328419|SUPERIORITY||Least Squares Mean Difference|-2.13|STANDARD_ERROR_OF_MEAN|0.508||0.0009|TWO_SIDED|95.0|-3.13|-1.13||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.13|-3.13|0.0009
71903180|NCT03855137|143328420|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|0.507||0.0002|TWO_SIDED|95.0|-3.52|-1.53||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.53|-3.52|0.0002
71903181|NCT03855137|143328420|SUPERIORITY||Least Squares Mean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.505||0.0024|TWO_SIDED|95.0|-3.09|-1.1|||MMRM|||||-1.10|-3.09|0.0024
71903182|NCT03855137|143328421|SUPERIORITY||Odds Ratio (OR)|2.13||||0.0003|TWO_SIDED|95.0|1.45|3.14||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.14|1.45|0.0003
71903183|NCT03855137|143328421|SUPERIORITY||Odds Ratio (OR)|2.04||||0.0009|TWO_SIDED|95.0|1.38|3.0||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||3.00|1.38|0.0009
71821326|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.055|0.033|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.033|-0.055|
71821327|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.058|0.029|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M21||0.029|-0.058|
71821328|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.061|0.03|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.030|-0.061|
71903184|NCT03855137|143328422|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0006|TWO_SIDED|95.0|1.38|2.98||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.98|1.38|0.0006
71903185|NCT03855137|143328422|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0009|TWO_SIDED|95.0|1.29|2.79||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|Logistic regression||Logistic regression for each atogepant group versus placebo with baseline monthly migraine days as covariate,stratification of region,acute medication overuse,migraine prevention medication and number of failures,treatment group as fixed factors.|||2.79|1.29|0.0009
71903186|NCT03855137|143328423|SUPERIORITY||Least Squares Mean Difference|7.43|STANDARD_ERROR_OF_MEAN|1.864||0.0006|TWO_SIDED|95.0|3.77|11.09||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||11.09|3.77|0.0006
71903187|NCT03855137|143328423|SUPERIORITY||Least Squares Mean Difference|5.78|STANDARD_ERROR_OF_MEAN|1.848||0.0024|TWO_SIDED|95.0|2.15|9.41||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||9.41|2.15|0.0024
71903188|NCT03855137|143328424|SUPERIORITY||Least Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|0.968||0.0003|TWO_SIDED|95.0|-6.75|-2.95||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.95|-6.75|0.0003
71903189|NCT03855137|143328424|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|0.963||0.0009|TWO_SIDED|95.0|-5.27|-1.49||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.49|-5.27|0.0009
71903190|NCT03855137|143328425|SUPERIORITY||Least Squares Mean Difference|-4.19|STANDARD_ERROR_OF_MEAN|0.897||0.0003|TWO_SIDED|95.0|-5.95|-2.43||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-2.43|-5.95|0.0003
71903191|NCT03855137|143328425|SUPERIORITY||Least Squares Mean Difference|-2.71|STANDARD_ERROR_OF_MEAN|0.893||0.0025|TWO_SIDED|95.0|-4.47|-0.96||Adjusted p-value using graphical approach to control the overall type 1 error rate for multiple comparisons.|MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-0.96|-4.47|0.0025
71903192|NCT03855137|143328426|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.697||0.0006|TWO_SIDED|95.0|-4.67|-1.93|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.93|-4.67|0.0006
71903193|NCT03855137|143328426|SUPERIORITY||Least Squares Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|0.69||0.0024|TWO_SIDED|95.0|-4.02|-1.3|||MMRM||MMRM model=treatment group,visit,stratification by acute medication overuse,migraine prevention medication use and number of failures,region,and treatment group-by-visit as fixed factors and baseline and baseline-by-visit interaction as covariates.|||-1.30|-4.02|0.0024
71903194|NCT02435277|143328449|OTHER|||||||0.0475||||||Total daily dose is twice the respective dose, Pairwise Comparison using Control as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)||||0.0475
71903195|NCT02435277|143328449|OTHER|||||||0.0912|||||||ANCOVA|||||||0.0912
71903196|NCT02435277|143328449|OTHER|||||||0.0458|||||||ANCOVA|||||||0.0458
71903197|NCT02435277|143328450|OTHER|||||||0.26||||||Total daily dose is twice the respective dose Pairwise Comparison using Treatment D as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of Fssting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)||||0.26
71903198|NCT02435277|143328450|OTHER|||||||0.0083|||||||ANCOVA|||||||0.0083
71903199|NCT02435277|143328450|OTHER|||||||0.0317|||||||ANCOVA|||||||0.0317
71903200|NCT02065622|143328453|SUPERIORITY||Adjusted risk difference|2.5||||0.269|TWO_SIDED|95.0|-2.0|7.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.0|-2.0|0.269
71903201|NCT02065622|143328453|SUPERIORITY|||||||0.447|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.447
71680285|NCT02634268|142878507|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.45|TWO_SIDED|95.0|-0.84|1.89|||Mixed Models Analysis|Difference in average SF-12 MCS at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.89|-0.84|0.45
71821329|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.044|0.043|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M27||0.043|-0.044|
71903202|NCT02065622|143328453|SUPERIORITY||Adjusted risk difference|2.3||||0.301|TWO_SIDED|95.0|-2.0|6.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||6.6|-2.0|0.301
71821330|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.051|0.04|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.040|-0.051|
71821331|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.042|0.058|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M33||0.058|-0.042|
71821332|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.032||||90.0|-0.03|0.077|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.077|-0.030|
71821333|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.023||||90.0|-0.042|0.035|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.035|-0.042|
71821334|NCT00136916|143145116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.023|0.062|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||0.062|-0.023|
71821335|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.119|STANDARD_ERROR_OF_MEAN|0.058||||90.0|-0.215|-0.023|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M3||-0.023|-0.215|
71821336|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.067||||90.0|-0.133|0.087|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M6||0.087|-0.133|
71821337|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.069||||90.0|-0.104|0.124|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M9||0.124|-0.104|
71821338|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.075||||90.0|-0.033|0.214|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M12||0.214|-0.033|
71821339|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.081||||90.0|-0.081|0.185|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M15||0.185|-0.081|
71821340|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.087||||90.0|-0.054|0.234|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M18||0.234|-0.054|
71821341|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.085||||90.0|-0.073|0.208|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M21||0.208|-0.073|
71821342|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.096||||90.0|-0.058|0.257|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M24||0.257|-0.058|
71821343|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.09||||90.0|-0.143|0.154|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M3||0.154|-0.143|
71821344|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.094||||90.0|-0.119|0.19|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M6||0.190|-0.119|
71821345|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.2|0.161|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M1||0.161|-0.200|
71821346|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.101|0.263|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M3||0.263|-0.101|
71821347|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.108||||90.0|-0.038|0.32|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M6||0.320|-0.038|
71903203|NCT02065622|143328453|SUPERIORITY|||||||0.502|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.502
71821348|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.116||||90.0|-0.041|0.342|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M9||0.342|-0.041|
71821349|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.118||||90.0|-0.09|0.298|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M12||0.298|-0.090|
71821350|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|STANDARD_ERROR_OF_MEAN|0.125||||90.0|-0.132|0.279|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M15||0.279|-0.132|
71821351|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.111|0.284|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M18||0.284|-0.111|
71821352|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.141|0.27|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M21||0.270|-0.141|
71821353|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.123||||90.0|-0.156|0.249|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M24||0.249|-0.156|
71821354|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.124||||90.0|-0.138|0.272|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M27||0.272|-0.138|
71903204|NCT02065622|143328454|SUPERIORITY||Adjusted risk difference|9.9||||0.069|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.6|-0.8|0.069
71903205|NCT02065622|143328454|SUPERIORITY|||||||0.085|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.085
71903206|NCT02065622|143328454|SUPERIORITY||Adjusted risk difference|10.3||||0.045|TWO_SIDED|95.0|0.2|20.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.4|0.2|0.045
71903207|NCT02065622|143328454|SUPERIORITY|||||||0.106|||||||Breslow-Day test|Breslow-Day test of homogeneity across strata.||||||0.106
71903208|NCT02065622|143328455|SUPERIORITY||Adjusted risk difference|4.2||||0.181|TWO_SIDED|95.0|-2.0|10.5|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.5|-2.0|0.181
71903209|NCT02065622|143328455|SUPERIORITY||Adjusted risk difference|3.8||||0.2|TWO_SIDED|95.0|-2.0|9.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||9.7|-2.0|0.200
71903210|NCT02065622|143328456|SUPERIORITY||Adjusted risk difference|3.0||||0.3|TWO_SIDED|95.0|-2.6|8.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.6|-2.6|0.300
71903211|NCT02065622|143328456|SUPERIORITY||Adjusted risk difference|3.1||||0.254|TWO_SIDED|95.0|-2.2|8.4|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.4|-2.2|0.254
71903212|NCT02065622|143328457|SUPERIORITY||Adjusted risk difference|6.5||||0.05|TWO_SIDED|95.0|0.0|13.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.1|-0.0|0.050
71903213|NCT02065622|143328457|SUPERIORITY||Adjusted risk difference|4.8||||0.131|TWO_SIDED|95.0|-1.4|11.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||11.0|-1.4|0.131
71903214|NCT02065622|143328458|SUPERIORITY||Adjusted risk difference|7.3||||0.035|TWO_SIDED|95.0|0.5|14.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.1|0.5|0.035
71903215|NCT02065622|143328458|SUPERIORITY||Adjusted risk difference|8.7||||0.008|TWO_SIDED|95.0|2.3|15.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||15.1|2.3|0.008
71903216|NCT02065622|143328459|SUPERIORITY||Adjusted risk difference|3.2||||0.16|TWO_SIDED|95.0|-1.3|7.6|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.6|-1.3|0.160
71903217|NCT02065622|143328459|SUPERIORITY||Adjusted risk difference|2.9||||0.166|TWO_SIDED|95.0|-1.2|7.1|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||7.1|-1.2|0.166
71903218|NCT02065622|143328460|SUPERIORITY||Adjusted risk difference|8.3||||0.011|TWO_SIDED|95.0|1.9|14.7|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||14.7|1.9|0.011
71903219|NCT02065622|143328460|SUPERIORITY||Adjusted risk difference|7.0||||0.025|TWO_SIDED|95.0|0.9|13.0|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||13.0|0.9|0.025
71852942|NCT01837719|143219781|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.749|||||TWO_SIDED|90.0|0.658|0.852|||Mixed Models Analysis||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when administered as an FDC.||0.852|0.658|
71852943|NCT01837719|143219786|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.084|||||TWO_SIDED|90.0|1.014|1.158|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.158|1.014|
71852944|NCT01837719|143219786|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.349|||||TWO_SIDED|90.0|1.215|1.498|||Mixed Models Analysis||Geometric mean ratio of C24 was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.498|1.215|
71852945|NCT01837719|143219786|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.144||||||90.0|1.006|1.3|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC||1.300|1.006|
71852946|NCT01837719|143219786|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.231|||||TWO_SIDED|90.0|1.023|1.483|||||Geometric mean ratio was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.483|1.023|
71852947|NCT01837719|143219786|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.912||||||90.0|0.789|1.054|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.||1.054|0.789|
71852948|NCT01837719|143219788|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.023|||||TWO_SIDED|90.0|0.991|1.057|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.057|0.991|
71852949|NCT01837719|143219788|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.305|||||TWO_SIDED|90.0|1.215|1.402|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.402|1.215|
71852950|NCT01837719|143219788|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.085|||||TWO_SIDED|90.0|0.925|1.273|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir cobicistat||1.273|0.925|
71852951|NCT01837719|143219788|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.937|1.154|||||Geometric mean ratio was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||1.154|0.937|
71852952|NCT01837719|143219788|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.784|||||TWO_SIDED|90.0|0.717|0.858|||Mixed Models Analysis||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.||0.858|0.717|
71852953|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.983|1.057|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment A|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.057|0.983|
71852954|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.232||||||90.0|1.141|1.331|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.331|1.141|
71852955|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.102|||||TWO_SIDED|90.0|0.929|1.307|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.307|0.929|
71903220|NCT02065622|143328461|SUPERIORITY||Adjusted risk difference|4.2||||0.218|TWO_SIDED|95.0|-2.5|10.9|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||10.9|-2.5|0.218
71903221|NCT02065622|143328461|SUPERIORITY||Adjusted risk difference|2.4||||0.456|TWO_SIDED|95.0|-4.0|8.8|||Cochran-Mantel-Haenszel||Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.||8.8|-4.0|0.456
71852956|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.127||||||90.0|1.017|1.248|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC.||1.248|1.017|
71903222|NCT02065622|143328462|SUPERIORITY||Adjusted risk difference|9.5||||0.098|TWO_SIDED|95.0|-1.7|20.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.8|-1.7|0.098
71903223|NCT02065622|143328462|SUPERIORITY||Adjusted risk difference|9.9||||0.066|TWO_SIDED|95.0|-0.7|20.5|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||20.5|-0.7|0.066
71903224|NCT02065622|143328463|SUPERIORITY||Adjusted risk difference|21.5||||0.002|TWO_SIDED|95.0|7.6|35.4|||Cochran-Mantel-Haenszel|Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.||Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||35.4|7.6|0.002
71903225|NCT02065622|143328463|SUPERIORITY||Adjusted risk difference|19.7||||0.003|TWO_SIDED|95.0|6.6|32.7|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||32.7|6.6|0.003
71903226|NCT02065622|143328464|SUPERIORITY||Adjusted risk difference|11.5||||0.093|TWO_SIDED|95.0|-1.9|25.0|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.0|-1.9|0.093
71903227|NCT02065622|143328464|SUPERIORITY||Adjusted risk difference|11.1||||0.088|TWO_SIDED|95.0|-1.7|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-1.7|0.088
71903228|NCT02065622|143328465|SUPERIORITY||Adjusted risk difference|15.9||||0.161|TWO_SIDED|95.0|-6.3|38.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.2|-6.3|0.161
71903229|NCT02065622|143328465|SUPERIORITY||Adjusted risk difference|10.4||||0.312|TWO_SIDED|95.0|-9.8|30.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||30.6|-9.8|0.312
71903230|NCT02065622|143328466|SUPERIORITY||Adjusted risk difference|12.3||||0.272|TWO_SIDED|95.0|-9.7|34.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||34.4|-9.7|0.272
71903231|NCT02065622|143328466|SUPERIORITY||Adjusted risk difference|5.3||||0.6|TWO_SIDED|95.0|-14.6|25.2|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||25.2|-14.6|0.600
71903232|NCT02065622|143328467|SUPERIORITY||Adjusted risk difference|23.8||||0.074|TWO_SIDED|95.0|-2.3|49.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||49.9|-2.3|0.074
71903233|NCT02065622|143328467|SUPERIORITY||Adjusted risk difference|15.0||||0.21|TWO_SIDED|95.0|-8.5|38.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||38.4|-8.5|0.210
71903234|NCT02065622|143328468|SUPERIORITY||Adjusted risk difference|20.0||||0.151|TWO_SIDED|95.0|-7.3|47.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||47.3|-7.3|0.151
71903235|NCT02065622|143328468|SUPERIORITY||Adjusted risk difference|12.8||||0.299|TWO_SIDED|95.0|-11.3|36.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||36.8|-11.3|0.299
71903236|NCT02065622|143328469|SUPERIORITY||Adjusted risk difference|4.5||||0.422|TWO_SIDED|95.0|-6.4|15.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||15.3|-6.4|0.422
71903237|NCT02065622|143328469|SUPERIORITY||Adjusted risk difference|3.4||||0.513|TWO_SIDED|95.0|-6.8|13.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||13.6|-6.8|0.513
71852957|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.825|0.96|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and a light meal on the natural logarithms of exposure of cobicistat when given as an FDC||0.960|0.825|
71852958|NCT01837719|143219790|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T), and AUC(INF).|Geometric mean ratio|1.019|||||TWO_SIDED|90.0|0.982|1.058|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.||1.058|0.982|
71852959|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.24|||||TWO_SIDED|90.0|1.148|1.34|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC||1.340|1.148|
71852960|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.976|||||TWO_SIDED|90.0|0.886|1.075|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.||1.075|0.886|
71852961|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.116|||||TWO_SIDED|90.0|1.012|1.231|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and fasted on the natural logarithms of exposure of cobicistat when given as an FDC.||1.231|1.012|
71852962|NCT01837719|143219790|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.904|||||TWO_SIDED|90.0|0.836|0.978|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and light meal on the natural logarithms of exposure of atazanavir when given as an FDC||0.978|0.836|
71852963|NCT02995733|143219802|SUPERIORITY|Asthma exacerbation rates during follow-up between two randomized treatment arms are compared using the Andersen-Gill adaptation of time-to-event Cox proportional hazard model with robust standard errors to account for multiple occurrences of the outcome in each patient (Andersen Gill, 1982). This analysis is based on intention-to-treat (ITT) patient population.|Cox Proportional Hazard|0.85||||0.048|TWO_SIDED|95.0|0.72|0.999|||Cox proportional hazard model|Pre-specified baseline covariates are adjusted in the model. A time-dependent covariate for the COVID pandemic is also included in adjustments.||||0.999|0.720|0.048
71852964|NCT02995733|143219803|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ACT change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
71852965|NCT02995733|143219804|SUPERIORITY|Mixed model is used to compare the treatment effects. The response variable is ASUI change at each monthly assessment from baseline. The covariates (included as fixed effects) include randomized treatment arm, continuous time of assessment as a linear and quadratic term and the interactions of the treatment arm with the time variables. Independent random effects include intercept and time variables. The model adjusts for all the baseline covariates included in the primary analysis.|Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.05||||||||0.05|0.02|
71852966|NCT02995733|143219805|SUPERIORITY|Negative binomial regression model is used, with time as an offset to account for differential duration of follow-up. The model adjusts for all the baseline covariates included in the primary analysis.|Rate ratio|0.8|||||TWO_SIDED|95.0|0.67|0.95||||||||0.95|0.67|
71852967|NCT02720198|143219813|SUPERIORITY||Mean Difference (Final Values)|1.159|STANDARD_ERROR_OF_MEAN|1.834||0.53|TWO_SIDED|95.0|-2.518|4.836|||t-test, 2 sided|||||4.836|-2.518|0.53
71852968|NCT02720198|143219814|SUPERIORITY||Odds Ratio (OR)|0.492|STANDARD_ERROR_OF_MEAN|0.806||0.428|TWO_SIDED|95.0|0.101|2.388|||Mantel Haenszel|||||2.388|0.101|0.428
71852969|NCT02720198|143219815|SUPERIORITY||Odds Ratio (OR)|0.451|STANDARD_ERROR_OF_MEAN|0.724||0.272|TWO_SIDED|95.0|0.109|1.866|||Mantel Haenszel|||||1.866|0.109|0.272
71852970|NCT02720198|143219816|SUPERIORITY||Mean Difference (Final Values)|-0.624|STANDARD_ERROR_OF_MEAN|1.428||0.664|TWO_SIDED|95.0|-3.484|2.236|||t-test, 2 sided|||||2.236|-3.484|0.664
71852971|NCT02720198|143219817|SUPERIORITY||Mean Difference (Final Values)|2.34|STANDARD_ERROR_OF_MEAN|2.199||0.292|TWO_SIDED|95.0|-2.07|6.75|||t-test, 2 sided|||||6.750|-2.070|0.292
71852972|NCT02720198|143219818|SUPERIORITY||Odds Ratio (OR)|1.063|STANDARD_ERROR_OF_MEAN|0.525||0.884|TWO_SIDED|95.0|0.38|2.971|||Mantel Haenszel|||||2.971|0.380|0.884
71903238|NCT02065622|143328470|SUPERIORITY||Adjusted risk difference|3.7||||0.351|TWO_SIDED|95.0|-4.1|11.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.4|-4.1|0.351
71852973|NCT02720198|143219819|SUPERIORITY||Odds Ratio (OR)|0.875|STANDARD_ERROR_OF_MEAN|0.65||0.905|TWO_SIDED|95.0|0.245|3.129|||Mantel Haenszel|||||3.129|0.245|0.905
71852974|NCT02720198|143219820|SUPERIORITY||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.423||0.254|TWO_SIDED|95.0|-1.211|4.492|||t-test, 2 sided|||||4.492|-1.211|0.254
71852975|NCT02720198|143219821|SUPERIORITY||Mean Difference (Final Values)|-3.693|STANDARD_ERROR_OF_MEAN|1.91||0.058|TWO_SIDED|95.0|-7.52|0.134|||t-test, 2 sided|||||0.134|-7.520|0.058
71852976|NCT02720198|143219822|SUPERIORITY||Mean Difference (Final Values)|-0.236|STANDARD_ERROR_OF_MEAN|2.158||0.913|TWO_SIDED|95.0|-4.559|4.088|||t-test, 2 sided|||||4.088|-4.559|0.913
71903239|NCT02065622|143328470|SUPERIORITY||Adjusted risk difference|3.9||||0.292|TWO_SIDED|95.0|-3.3|11.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||11.1|-3.3|0.292
71903240|NCT02065622|143328471|SUPERIORITY||Adjusted risk difference|5.4||||0.121|TWO_SIDED|95.0|-1.4|12.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.1|-1.4|0.121
71903241|NCT02065622|143328471|SUPERIORITY||Adjusted risk difference|6.5||||0.046|TWO_SIDED|95.0|0.1|12.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||12.8|0.1|0.046
71903242|NCT02065622|143328472|SUPERIORITY||Adjusted risk difference|7.5||||0.159|TWO_SIDED|95.0|-2.9|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-2.9|0.159
71903243|NCT02065622|143328472|SUPERIORITY||Adjusted risk difference|8.0||||0.109|TWO_SIDED|95.0|-1.8|17.9|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||17.9|-1.8|0.109
71903244|NCT02065622|143328473|SUPERIORITY||Adjusted risk difference|1.4||||0.903|TWO_SIDED|95.0|-21.0|23.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||23.8|-21.0|0.903
71903245|NCT02065622|143328473|SUPERIORITY||Adjusted risk difference|1.3||||0.901|TWO_SIDED|95.0|-18.8|21.3|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||21.3|-18.8|0.901
71903246|NCT02065622|143328474|SUPERIORITY||Adjusted risk difference|7.7||||0.16|TWO_SIDED|95.0|-3.0|18.4|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.4|-3.0|0.160
71903247|NCT02065622|143328474|SUPERIORITY||Adjusted risk difference|9.1||||0.076|TWO_SIDED|95.0|-0.9|19.1|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||19.1|-0.9|0.076
71903248|NCT02065622|143328475|SUPERIORITY||Adjusted risk difference|7.3||||0.207|TWO_SIDED|95.0|-4.0|18.6|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||18.6|-4.0|0.207
71903249|NCT02065622|143328475|SUPERIORITY||Adjusted risk difference|4.2||||0.44|TWO_SIDED|95.0|-6.4|14.8|||Cochran-Mantel-Haenszel||Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.|Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.||14.8|-6.4|0.440
71903250|NCT04973228|143328483|SUPERIORITY||Odds Ratio (OR)|2.79|||<|0.0001|TWO_SIDED|95.0|1.75|4.45|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 8||4.45|1.75|<0.0001
71903251|NCT04973228|143328484|SUPERIORITY||Odds Ratio (OR)|2.95||||0.0001|TWO_SIDED|95.0|1.68|5.19|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 8||5.19|1.68|0.0001
71903252|NCT04973228|143328485|SUPERIORITY||Odds Ratio (OR)|2.62||||0.0007|TWO_SIDED|95.0|1.47|4.67|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 4||4.67|1.47|0.0007
71903253|NCT04973228|143328486|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0016|TWO_SIDED|95.0|1.41|5.34|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|WI-NRS Success at Week 2||5.34|1.41|0.0016
71821355|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.132||||90.0|-0.171|0.264|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M30||0.264|-0.171|
71903254|NCT04973228|143328487|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0002|TWO_SIDED|95.0|1.54|3.84|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 2||3.84|1.54|0.0002
71903255|NCT04973228|143328488|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.06|5.03|||Cochran-Mantel-Haenszel|Pooled by site and IGA strata with multiple imputation to handle missing data|Pooled by site and IGA strata with multiple imputation to handle missing data|IGA Success at Week 4||5.03|2.06|<0.0001
71903256|NCT04973228|143328489|SUPERIORITY||Odds Ratio (OR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.56|3.73|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Scaling Score of 0 at Week 8||3.73|1.56|<0.0001
71903257|NCT04973228|143328490|SUPERIORITY||Odds Ratio (OR)|3.22|||<|0.0001|TWO_SIDED|95.0|2.05|5.06|||Cochran-Mantel-Haenszel|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Stratified by pooled site and IGA strata with multiple imputation to handle missing data|Erythema Score of 0 at Week 8||5.06|2.05|<0.0001
71903258|NCT04237207|143328491|NON_INFERIORITY|The primary efficacy objective is to demonstrate non-inferiority of AutoSense on the M90 processor compared to AutoSound on the Q90 processor for the AzBio sentence test in quiet mode based on a paired t-test. The primary efficacy analyses will test the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quiet mode (AutoSense on M90 - AutoSound on Q90) are less than or equal to -10 percentage points.||||||0.001|||||||t-test, 2 sided|||||||0.0010
71903259|NCT04237207|143328492|NON_INFERIORITY|The 1st secondary endpoint was to demonstrate that speech recognition in noise with AutoSense on a 301-M062 processor was no worse than speech recognition in noise with currently approved software on a Q90 processor.||||||0.001|||||||t-test, 2 sided|||||||0.0010
71903260|NCT04237207|143328493|NON_INFERIORITY|"The 2nd secondary endpoint was to demonstrate increased speech recognition in noise with the 301-M062 sound processor when comparing Omnidirectional program to AutoSense."|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71903261|NCT06704178|143328506|SUPERIORITY|||||||0.488445|||||||Multiple t-tests|||||||0.488445
71903262|NCT06704178|143328507|SUPERIORITY|Between-group comparison.||||||0.98317||||||Between-group comparison.|t-test, 2 sided|||||||0.98317
71821356|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.824|STANDARD_ERROR_OF_MEAN|8.319||||90.0|-3.92|23.569|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M33||23.569|-3.920|
71852977|NCT02720198|143219823|SUPERIORITY||Mean Difference (Final Values)|-0.459|STANDARD_ERROR_OF_MEAN|1.035||0.66|TWO_SIDED|95.0|-2.54|1.623|||t-test, 2 sided|||||1.623|-2.540|0.660
71903263|NCT06704178|143328508|SUPERIORITY|||||||0.98317|||||||t-test, 2 sided|||||||0.98317
71821357|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.197||||90.0|-0.316|0.337|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M36||0.337|-0.316|
71852978|NCT02592434|143219853|SUPERIORITY||Difference in percentage|-23.69||||0.0031|TWO_SIDED|95.0|-39.41|-7.97||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||-7.97|-39.41|0.0031
71852979|NCT02592434|143219854|SUPERIORITY||Difference in percentage|19.52||||0.0166|TWO_SIDED|95.0|3.55|35.5||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||35.50|3.55|0.0166
71852980|NCT02592434|143219855|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||39.41|7.97|0.0031
71852981|NCT02592434|143219856|SUPERIORITY||Difference in percentage|17.02||||0.0387|TWO_SIDED|95.0|0.88|33.17||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.||33.17|0.88|0.0387
71903264|NCT06704178|143328509|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
71903265|NCT06704178|143328510|SUPERIORITY|||||||0.919209|||||||t-test, 2 sided|||||||0.919209
71903266|NCT06704178|143328511|SUPERIORITY|||||||0.954882||||||Comparison at Month 2|t-test, 2 sided|||||||0.954882
71903267|NCT06704178|143328511|SUPERIORITY|||||||0.246176||||||Comparison at Month 4|t-test, 2 sided|||||||0.246176
71903268|NCT06704178|143328511|SUPERIORITY|||||||0.954882||||||Comparison at Month 6|t-test, 2 sided|||||||0.954882
71903269|NCT06704178|143328512|SUPERIORITY|||||||0.483382||||||Comparison at Month 2|t-test, 2 sided|||||||0.483382
71903270|NCT06704178|143328512|SUPERIORITY|||||||0.483382||||||Comparison at Month 4|t-test, 2 sided|||||||0.483382
71821358|NCT00136916|143145122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.163||||90.0|-0.245|0.292|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext FU M3||0.292|-0.245|
71903271|NCT06704178|143328512|SUPERIORITY|||||||0.726742||||||Comparison at Month 6|t-test, 2 sided|||||||0.726742
71903272|NCT06704178|143328513|SUPERIORITY|||||||0.999216||||||Comparison at Month 1|t-test, 2 sided|||||||0.999216
71903273|NCT06704178|143328513|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71903274|NCT06704178|143328513|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
71903275|NCT06704178|143328513|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
71903276|NCT06704178|143328513|SUPERIORITY|||||||0.952545||||||Comparison at Month 5|t-test, 2 sided|||||||0.952545
71903277|NCT06704178|143328513|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
71903278|NCT06704178|143328514|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
71903279|NCT06704178|143328514|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71903280|NCT06704178|143328514|SUPERIORITY|||||||0.999801|||||||t-test, 2 sided|||||||0.999801
71821359|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.39|STANDARD_ERROR_OF_MEAN|4.054||||90.0|-19.07|-5.71|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M3||-5.710|-19.07|
71821360|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.21|STANDARD_ERROR_OF_MEAN|4.795||||90.0|-22.11|-6.312|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M6||-6.312|-22.11|
71821361|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.96|STANDARD_ERROR_OF_MEAN|4.92||||90.0|-19.07|-2.852|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M12||-2.852|-19.07|
71821362|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.56|STANDARD_ERROR_OF_MEAN|5.052||||90.0|-20.89|-4.232|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M24||-4.232|-20.89|
71821363|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.83|STANDARD_ERROR_OF_MEAN|21.867||||90.0|-80.69|47.019|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M3||47.019|-80.69|
71821364|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.578|STANDARD_ERROR_OF_MEAN|7.173||||90.0|-9.257|14.412|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M6||14.412|-9.257|
71821365|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|STANDARD_ERROR_OF_MEAN|6.007||||90.0|-19.37|0.45|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M1||0.450|-19.37|
71821366|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.481|STANDARD_ERROR_OF_MEAN|6.446||||90.0|-20.11|1.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M3||1.153|-20.11|
71821367|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.76|STANDARD_ERROR_OF_MEAN|6.785||||90.0|-21.95|0.438|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M6||0.438|-21.95|
71821368|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.827|STANDARD_ERROR_OF_MEAN|6.154||||90.0|-16.98|3.328|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M9||3.328|-16.98|
71821369|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.287|STANDARD_ERROR_OF_MEAN|7.192||||90.0|-19.15|4.579|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M12||4.579|-19.15|
71821370|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.848|STANDARD_ERROR_OF_MEAN|7.219||||90.0|-13.76|10.066|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M15||10.066|-13.76|
71821371|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.022|STANDARD_ERROR_OF_MEAN|7.156||||90.0|-20.83|2.79|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M18||2.790|-20.83|
71821372|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.078|STANDARD_ERROR_OF_MEAN|7.217||||90.0|-18.99|4.834|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M21||4.834|-18.99|
71821373|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.53|STANDARD_ERROR_OF_MEAN|7.329||||90.0|-24.63|-0.429|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M24||-0.429|-24.63|
71821374|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.07|STANDARD_ERROR_OF_MEAN|6.895||||90.0|-30.45|-7.685|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M27||-7.685|-30.45|
71821375|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.22|STANDARD_ERROR_OF_MEAN|7.223||||90.0|-15.15|8.705|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M30||8.705|-15.15|
71821376|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49|STANDARD_ERROR_OF_MEAN|7.625||||90.0|-21.09|4.107|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M33||4.107|-21.09|
71821377|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.88|STANDARD_ERROR_OF_MEAN|8.906||||90.0|-36.66|-7.105|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M36||-7.105|-36.66|
71821378|NCT00136916|143145123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.673|STANDARD_ERROR_OF_MEAN|8.77||||90.0|-19.16|9.812|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext FU M3||9.812|-19.16|
71821379|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|STANDARD_ERROR_OF_MEAN|0.217||||90.0|-0.416|0.299|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M3||0.299|-0.416|
71821380|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.735|STANDARD_ERROR_OF_MEAN|0.297||||90.0|-1.224|-0.246|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M6||-0.246|-1.224|
71821381|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.642|STANDARD_ERROR_OF_MEAN|0.37||||90.0|-1.251|-0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M12||-0.032|-1.251|
71821382|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.355|STANDARD_ERROR_OF_MEAN|0.464||||90.0|-2.12|-0.589|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M24||-0.589|-2.120|
71821383|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.303|STANDARD_ERROR_OF_MEAN|0.475||||90.0|-2.086|-0.52|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M3||-0.520|-2.086|
71821384|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.557|STANDARD_ERROR_OF_MEAN|0.596||||90.0|-2.539|-0.575|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M6||-0.575|-2.539|
71821385|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.904|STANDARD_ERROR_OF_MEAN|0.603||||90.0|-1.898|0.09|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M1||0.090|-1.898|
71821386|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.573||||90.0|-2.225|-0.334|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M3||-0.334|-2.225|
71903281|NCT06704178|143328514|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
71821387|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.834|STANDARD_ERROR_OF_MEAN|0.652||||90.0|-1.909|0.241|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M6||0.241|-1.909|
71821388|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.001|STANDARD_ERROR_OF_MEAN|0.654||||90.0|-2.08|0.078|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M9||0.078|-2.080|
71903282|NCT06704178|143328514|SUPERIORITY|||||||0.993223||||||Comparison at Month 5|t-test, 2 sided|||||||0.993223
71903283|NCT06704178|143328514|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
71903284|NCT06704178|143328515|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
71821389|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.316|STANDARD_ERROR_OF_MEAN|0.676||||90.0|-2.431|-0.2|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M12||-0.200|-2.431|
71821390|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.512|STANDARD_ERROR_OF_MEAN|0.696||||90.0|-2.661|-0.363|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M15||-0.363|-2.661|
71821391|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.313|STANDARD_ERROR_OF_MEAN|0.916||||90.0|-2.824|0.198|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M18||0.198|-2.824|
71821392|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.399|STANDARD_ERROR_OF_MEAN|0.904||||90.0|-3.891|-0.907|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M21||-0.907|-3.891|
71821393|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.566|STANDARD_ERROR_OF_MEAN|0.788||||90.0|-2.867|-0.265|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M24||-0.265|-2.867|
71821394|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.72|STANDARD_ERROR_OF_MEAN|1.041||||90.0|-4.439|-1.001|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M27||-1.001|-4.439|
71821395|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.401|STANDARD_ERROR_OF_MEAN|0.82||||90.0|-2.755|-0.047|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M30||-0.047|-2.755|
71821396|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.281|STANDARD_ERROR_OF_MEAN|0.908||||90.0|-3.781|-0.782|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M33||-0.782|-3.781|
71821397|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.766|STANDARD_ERROR_OF_MEAN|1.305||||90.0|-4.932|-0.599|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M36||-0.599|-4.932|
71821398|NCT00136916|143145124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.637|STANDARD_ERROR_OF_MEAN|0.898||||90.0|-3.12|-0.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext FU M3||-0.153|-3.120|
71821399|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.466|-0.037|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M3||-0.037|-0.466|
71821400|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.095|STANDARD_ERROR_OF_MEAN|0.139||||90.0|-0.323|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6||0.134|-0.323|
71821401|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.146||||90.0|-0.158|0.325|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M9||0.325|-0.158|
71821402|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.266|STANDARD_ERROR_OF_MEAN|0.156||||90.0|-0.524|-0.009|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12||-0.009|-0.524|
71821403|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|0.165||||90.0|-0.453|0.091|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M15||0.091|-0.453|
71903285|NCT06704178|143328515|SUPERIORITY|||||||0.999838||||||Comparison at Month 2|t-test, 2 sided|||||||0.999838
71903286|NCT06704178|143328515|SUPERIORITY|||||||0.991697||||||Comparison at Month 3|t-test, 2 sided|||||||0.991697
71903287|NCT06704178|143328515|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
71903288|NCT06704178|143328515|SUPERIORITY|||||||0.581904||||||Comparison at Month 5|t-test, 2 sided|||||||0.581904
71903289|NCT06704178|143328515|SUPERIORITY|||||||0.999866||||||Comparison at Month 6|t-test, 2 sided|||||||0.999866
71903290|NCT06704178|143328516|SUPERIORITY|||||||0.999835||||||Comparison at Month 1|t-test, 2 sided|||||||0.999835
71903291|NCT06704178|143328516|SUPERIORITY|||||||0.962016||||||Comparison at Month 2|t-test, 2 sided|||||||0.962016
71903292|NCT06704178|143328516|SUPERIORITY|||||||0.995044||||||Comparison at Month 3|t-test, 2 sided|||||||0.995044
71821404|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.141|STANDARD_ERROR_OF_MEAN|0.173||||90.0|-0.427|0.145|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M18||0.145|-0.427|
71821405|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.155|STANDARD_ERROR_OF_MEAN|0.176||||90.0|-0.445|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M21||0.134|-0.445|
71821406|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.189||||90.0|-0.193|0.431|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24||0.431|-0.193|
71821407|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.617|STANDARD_ERROR_OF_MEAN|0.179||||90.0|0.322|0.911|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1||0.911|0.322|
71821408|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354|STANDARD_ERROR_OF_MEAN|0.184||||90.0|0.051|0.657|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3||0.657|0.051|
71821409|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.318|STANDARD_ERROR_OF_MEAN|0.186||||90.0|0.011|0.626|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6||0.626|0.011|
71903293|NCT06704178|143328516|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
71903294|NCT06704178|143328516|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
71821410|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.22||||90.0|-0.227|0.5|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1||0.500|-0.227|
71821411|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.235||||90.0|-0.289|0.485|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3||0.485|-0.289|
71821412|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.226||||90.0|-0.576|0.172|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6||0.172|-0.576|
71821413|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.257||||90.0|-0.18|0.669|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M9||0.669|-0.180|
71821414|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|STANDARD_ERROR_OF_MEAN|0.248||||90.0|-0.284|0.535|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12||0.535|-0.284|
71821415|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.253||||90.0|-0.395|0.441|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M15||0.441|-0.395|
71821416|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.247||||90.0|-0.262|0.554|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18||0.554|-0.262|
71821417|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.321|STANDARD_ERROR_OF_MEAN|0.278||||90.0|-0.138|0.78|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M21||0.780|-0.138|
71821418|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.043|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.419|0.506|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24||0.506|-0.419|
71903295|NCT06704178|143328516|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
71821419|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.284||||90.0|-0.279|0.659|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M27||0.659|-0.279|
71821420|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|STANDARD_ERROR_OF_MEAN|0.28||||90.0|-0.579|0.346|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30||0.346|-0.579|
71821421|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.273||||90.0|-0.189|0.714|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M33||0.714|-0.189|
71821422|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.267|STANDARD_ERROR_OF_MEAN|0.383||||90.0|-0.37|0.904|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36||0.904|-0.370|
71821423|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.399|STANDARD_ERROR_OF_MEAN|0.244||||90.0|-0.003|0.802|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF||0.802|-0.003|
71821424|NCT00136916|143145130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.619|STANDARD_ERROR_OF_MEAN|0.292||||90.0|0.137|1.102|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3||1.102|0.137|
71821425|NCT01152554|143145143|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.24||0.697|TWO_SIDED|95.0|0.54|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.50|0.54|0.697
71821426|NCT01152554|143145144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.27||0.582|TWO_SIDED|95.0|0.45|1.57|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.57|0.45|0.582
71903296|NCT06704178|143328517|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
71903297|NCT06704178|143328517|SUPERIORITY|||||||0.999524||||||Comparison at Month 2|t-test, 2 sided|||||||0.999524
71903298|NCT06704178|143328517|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
71821427|NCT03486899|143145160|SUPERIORITY||Odds Ratio (OR)|2.65||||0.055|TWO_SIDED|95.0|0.88|8.52|||Cochran-Mantel-Haenszel|||||8.52|0.88|0.055
71821428|NCT03486899|143145160|SUPERIORITY||Odds Ratio (OR)|1.89||||0.245|TWO_SIDED|95.0|0.61|6.27|||Cochran-Mantel-Haenszel|||||6.27|0.61|0.245
71821429|NCT03486899|143145160|SUPERIORITY||Odds Ratio (OR)|2.17||||0.129|TWO_SIDED|95.0|0.71|7.1|||Cochran-Mantel-Haenszel|||||7.10|0.71|0.129
71821430|NCT03486899|143145161|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
71821431|NCT03486899|143145161|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
71821432|NCT03486899|143145161|SUPERIORITY||Odds Ratio (OR)|2.88||||0.079|TWO_SIDED|95.0|0.75|13.48|||Cochran-Mantel-Haenszel|||||13.48|0.75|0.079
71821433|NCT03486899|143145162|SUPERIORITY||Odds Ratio (OR)|2.07||||0.18|TWO_SIDED|95.0|0.63|7.47|||Cochran-Mantel-Haenszel|||||7.47|0.63|0.180
71821434|NCT03486899|143145162|SUPERIORITY||Odds Ratio (OR)|1.37||||0.612|TWO_SIDED|95.0|0.38|5.2|||Cochran-Mantel-Haenszel|||||5.20|0.38|0.612
71821435|NCT03486899|143145162|SUPERIORITY||Odds Ratio (OR)|2.59||||0.079|TWO_SIDED|95.0|0.81|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.81|0.079
71821436|NCT03486899|143145163|SUPERIORITY||Odds Ratio (OR)|0.39||||0.038|TWO_SIDED|95.0|0.15|1.03|||Cochran-Mantel-Haenszel|||||1.03|0.15|0.038
71821437|NCT03486899|143145163|SUPERIORITY||Odds Ratio (OR)|0.6||||0.256|TWO_SIDED|95.0|0.22|1.57|||Cochran-Mantel-Haenszel|||||1.57|0.22|0.256
71821438|NCT03486899|143145163|SUPERIORITY||Odds Ratio (OR)|0.65||||0.296|TWO_SIDED|95.0|0.25|1.73|||Cochran-Mantel-Haenszel|||||1.73|0.25|0.296
71821439|NCT03486899|143145164|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
71821440|NCT03486899|143145164|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
71680286|NCT02634268|142878508|SUPERIORITY||Mean Difference (Final Values)|-0.41||||0.009|TWO_SIDED|95.0|-0.71|-0.1|||Mixed Models Analysis|Difference in average Framingham Risk Score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.10|-0.71|0.009
71821441|NCT03486899|143145164|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
71821442|NCT03486899|143145165|SUPERIORITY||Odds Ratio (OR)|1.36||||0.718|TWO_SIDED|95.0|0.22|9.8|||Cochran-Mantel-Haenszel|||||9.80|0.22|0.718
71821443|NCT03486899|143145165|SUPERIORITY||Odds Ratio (OR)|0.64||||0.632|TWO_SIDED|95.0|0.05|5.87|||Cochran-Mantel-Haenszel|||||5.87|0.05|0.632
71821444|NCT03486899|143145165|SUPERIORITY||Odds Ratio (OR)|0.32||||0.293|TWO_SIDED|95.0|0.01|4.19|||Cochran-Mantel-Haenszel|||||4.19|0.01|0.293
71821445|NCT03486899|143145166|SUPERIORITY||Odds Ratio (OR)|2.55||||0.101|TWO_SIDED|95.0|0.73|10.12|||Cochran-Mantel-Haenszel|||||10.12|0.73|0.101
71821446|NCT03486899|143145166|SUPERIORITY||Odds Ratio (OR)|1.43||||0.587|TWO_SIDED|95.0|0.36|6.17|||Cochran-Mantel-Haenszel|||||6.17|0.36|0.587
71821447|NCT03486899|143145166|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
71821448|NCT03486899|143145167|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
71821449|NCT03486899|143145167|SUPERIORITY||Odds Ratio (OR)|1.83||||0.381|TWO_SIDED|95.0|0.43|9.1|||Cochran-Mantel-Haenszel|||||9.10|0.43|0.381
71821450|NCT03486899|143145167|SUPERIORITY||Odds Ratio (OR)|2.2||||0.214|TWO_SIDED|95.0|0.53|10.64|||Cochran-Mantel-Haenszel|||||10.64|0.53|0.214
71821451|NCT03486899|143145168|SUPERIORITY||Odds Ratio (OR)|2.85||||0.06|TWO_SIDED|95.0|0.83|11.21|||Cochran-Mantel-Haenszel|||||11.21|0.83|0.060
71821452|NCT03486899|143145168|SUPERIORITY||Odds Ratio (OR)|1.93||||0.276|TWO_SIDED|95.0|0.53|7.92|||Cochran-Mantel-Haenszel|||||7.92|0.53|0.276
71821453|NCT03486899|143145168|SUPERIORITY||Odds Ratio (OR)|1.72||||0.371|TWO_SIDED|95.0|0.45|7.2|||Cochran-Mantel-Haenszel|||||7.20|0.45|0.371
71821454|NCT03486899|143145169|SUPERIORITY||Odds Ratio (OR)|1.72||||0.242|TWO_SIDED|95.0|0.62|4.87|||Cochran-Mantel-Haenszel|||||4.87|0.62|0.242
71821455|NCT03486899|143145169|SUPERIORITY||Odds Ratio (OR)|1.1||||0.803|TWO_SIDED|95.0|0.37|3.26|||Cochran-Mantel-Haenszel|||||3.26|0.37|0.803
71821456|NCT03486899|143145169|SUPERIORITY||Odds Ratio (OR)|1.56||||0.35|TWO_SIDED|95.0|0.56|4.46|||Cochran-Mantel-Haenszel|||||4.46|0.56|0.350
71852982|NCT02592434|143219857|SUPERIORITY||Ls mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01||Threshold for significance at 0.05 level.|Mixed Model for Repeated Measures (MMRM)|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.01|-0.22|0.0292
71852983|NCT02592434|143219859|SUPERIORITY||Difference in percentage|-1.71||||0.741|TWO_SIDED|95.0|-11.82|8.41|||Normal approximation to the binomial|||at Week 20||8.41|-11.82|0.7410
71852984|NCT02592434|143219859|SUPERIORITY||Difference in percentage|-18.93||||0.0052|TWO_SIDED|95.0|-32.22|-5.64|||Normal approximation to the binomial|||at Week 24||-5.64|-32.22|0.0052
71852985|NCT02592434|143219859|SUPERIORITY||Difference in percentage|-19.09||||0.0093|TWO_SIDED|95.0|-33.48|-4.7|||Normal approximation to the binomial|||at Week 28||-4.70|-33.48|0.0093
71852986|NCT02592434|143219859|SUPERIORITY||Difference in percentage|-22.1||||0.0045|TWO_SIDED|95.0|-37.35|-6.86|||Normal approximation to the binomial|||at Week 32||-6.86|-37.35|0.0045
71852987|NCT02592434|143219859|SUPERIORITY||Difference in percentage|-23.57||||0.0027|TWO_SIDED|95.0|-38.97|-8.17|||Normal approximation to the binomial|||at Week 36||-8.17|-38.97|0.0027
71852988|NCT02592434|143219859|SUPERIORITY||Difference in percentage|-25.08||||0.0016|TWO_SIDED|95.0|-40.69|-9.47|||Normal approximation to the binomial|||at Week 40||-9.47|-40.69|0.0016
71821457|NCT01439711|143145234|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71821458|NCT01439711|143145235|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71821459|NCT01012973|143145248|SUPERIORITY_OR_OTHER||CMH adjusted difference|38.3|||<|0.0001|TWO_SIDED|95.0|24.4|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as Eylea minus Sham. A positive value shows Eylea showed a higher BCVA total score compared to Sham.|Null hypothesis of difference of Eylea minus Sham of 0 was tested. In the database close after Week 24, basis for primary efficacy evaluation, 56 Sham / 96 Eylea subjects were considered as week 24 completers.||52.1|24.4|<.0001
71852989|NCT02592434|143219863|SUPERIORITY||Difference in percentage|6.03||||0.301|TWO_SIDED|95.0|-5.4|17.46|||Normal approximation to the binomial|||at Week 20||17.46|-5.40|0.3010
71852990|NCT02592434|143219863|SUPERIORITY||Difference in percentage|17.54||||0.0108|TWO_SIDED|95.0|4.05|31.03|||Normal approximation to the binomial|||at Week 24||31.03|4.05|0.0108
71852991|NCT02592434|143219863|SUPERIORITY||Difference in percentage|19.13||||0.0103|TWO_SIDED|95.0|4.51|33.74|||Normal approximation to the binomial|||at Week 28||33.74|4.51|0.0103
71852992|NCT02592434|143219863|SUPERIORITY||Difference in percentage|23.53||||0.0025|TWO_SIDED|95.0|8.27|38.8|||Normal approximation to the binomial|||at Week 32||38.80|8.27|0.0025
71852993|NCT02592434|143219863|SUPERIORITY||Difference in percentage|25.04||||0.0016|TWO_SIDED|95.0|9.52|40.56|||Normal approximation to the binomial|||at Week 36||40.56|9.52|0.0016
71852994|NCT02592434|143219863|SUPERIORITY||Difference in percentage|23.69||||0.0031|TWO_SIDED|95.0|7.97|39.41|||Normal approximation to the binomial|||at Week 40||39.41|7.97|0.0031
71852995|NCT02592434|143219865|SUPERIORITY||Difference in percentage|-1.15||||0.8119|TWO_SIDED|95.0|-10.63|8.33|||Normal approximation for binomial|||Double Blind Baseline (Week 18)||8.33|-10.63|0.8119
71852996|NCT02592434|143219865|SUPERIORITY||Difference in percentage|7.66||||0.2682|TWO_SIDED|95.0|-5.9|21.21|||Normal approximation for binomial|||Week 20||21.21|-5.90|0.2682
71852997|NCT02592434|143219865|SUPERIORITY||Difference in percentage|21.98||||0.0034|TWO_SIDED|95.0|7.26|36.71|||Normal approximation for binomial|||Week 24||36.71|7.26|0.0034
71903299|NCT06704178|143328517|SUPERIORITY|||||||0.772865||||||Comparison at Month 4|t-test, 2 sided|||||||0.772865
71903300|NCT06704178|143328517|SUPERIORITY|||||||0.91384||||||Comparison at Month 5|t-test, 2 sided|||||||0.91384
71903301|NCT06704178|143328517|SUPERIORITY|||||||0.992841||||||Comparison at Month 6|t-test, 2 sided|||||||0.992841
71903302|NCT06704178|143328518|SUPERIORITY|||||||0.999732||||||Comparison at Month 1|t-test, 2 sided|||||||0.999732
71903303|NCT06704178|143328518|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71903304|NCT06704178|143328518|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
71903305|NCT06704178|143328518|SUPERIORITY||||||>|0.999999||||||Comparison at Month 4|t-test, 2 sided|||||||>0.999999
71903306|NCT06704178|143328518|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
71903307|NCT06704178|143328518|SUPERIORITY||||||>|0.999999||||||Comparison at Month 6|t-test, 2 sided|||||||>0.999999
71903308|NCT06704178|143328519|SUPERIORITY|||||||0.999851||||||Comparison at Month 1|t-test, 2 sided|||||||0.999851
71821460|NCT01012973|143145249|SUPERIORITY_OR_OTHER||Difference in Least square means|14.7|||<|0.0001|TWO_SIDED|95.0|10.8|18.7||As primary efficacy evaluation was significant, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANOVA|ANOVA, adjusting for region and baseline BCVA category as fixed factors.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham. If primary efficacy was successful, secondary efficacy endpoints were tested in a pre-specified fixed sequence testing procedure. Change in BCVA letter score was to be tested first in this sequence.||18.7|10.8|<.0001
71852998|NCT02592434|143219865|SUPERIORITY||Difference in percentage|17.9||||0.0233|TWO_SIDED|95.0|2.44|33.36|||Normal approximation for binomial|||Week 28||33.36|2.44|0.0233
71852999|NCT02592434|143219865|SUPERIORITY||Difference in percentage|25.16||||0.0018|TWO_SIDED|95.0|9.39|40.93|||Normal approximation for binomial|||Week 32||40.93|9.39|0.0018
71853000|NCT02592434|143219865|SUPERIORITY||Difference in percentage|20.91||||0.0099|TWO_SIDED|95.0|5.01|36.81|||Normal approximation for binomial|||Week 36||36.81|5.01|0.0099
71853001|NCT02592434|143219865|SUPERIORITY||Difference in percentage|22.34||||0.0058|TWO_SIDED|95.0|6.46|38.22|||Normal approximation for binomial|||Week 40||38.22|6.46|0.0058
71853002|NCT02592434|143219867|SUPERIORITY||Difference in percentage|3.77||||0.6348|TWO_SIDED|95.0|-11.79|19.33|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||19.33|-11.79|0.6348
71853003|NCT02592434|143219867|SUPERIORITY||Difference in percentage|2.62||||0.7525|TWO_SIDED|95.0|-13.66|18.9|||Normal approximation to the binomial|||Week 20||18.90|-13.66|0.7525
71853004|NCT02592434|143219867|SUPERIORITY||Difference in percentage|14.05||||0.0908|TWO_SIDED|95.0|-2.23|30.33|||Normal approximation to the binomial|||Week 24||30.33|-2.23|0.0908
71853005|NCT02592434|143219867|SUPERIORITY||Difference in percentage|7.02||||0.4026|TWO_SIDED|95.0|-9.38|23.43|||Normal approximation to the binomial|||Week 28||23.43|-9.38|0.4026
71853006|NCT02592434|143219867|SUPERIORITY||Difference in percentage|18.37||||0.0258|TWO_SIDED|95.0|2.22|34.52|||Normal approximation to the binomial|||Week 32||34.52|2.22|0.0258
71853007|NCT02592434|143219867|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 36||35.88|3.88|0.0149
71853008|NCT02592434|143219867|SUPERIORITY||Difference in percentage|19.88||||0.0149|TWO_SIDED|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 40||35.88|3.88|0.0149
71853009|NCT02592434|143219869|SUPERIORITY||Difference in percentage|-5.24||||0.515|TWO_SIDED|95.0|-21.0|10.53|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||10.53|-21.00|0.5150
71853010|NCT02592434|143219869|SUPERIORITY||Difference in percentage|9.01||||0.24||95.0|-6.02|24.03|||Normal approximation to the binomial|||Week 20||24.03|-6.02|0.2400
71853011|NCT02592434|143219869|SUPERIORITY||Difference in percentage|8.93||||0.2557|TWO_SIDED|95.0|-6.47|24.33|||Normal approximation to the binomial|||Week 24||24.33|-6.47|0.2557
71853012|NCT02592434|143219869|SUPERIORITY||Difference in percentage|8.97||||0.2481|TWO_SIDED|95.0|-6.25|24.19|||Normal approximation to the binomial|||Week 28||24.19|-6.25|0.2481
71853013|NCT02592434|143219869|SUPERIORITY||Difference in percentage|16.03||||0.0356|TWO_SIDED|95.0|1.08|30.98|||Normal approximation to the binomial|||Week 32||30.98|1.08|0.0356
71853014|NCT02592434|143219869|SUPERIORITY||Difference in percentage|18.89||||0.0115|TWO_SIDED|95.0|4.24|33.54|||Normal approximation to the binomial|||Week 36||33.54|4.24|0.0115
71853015|NCT02592434|143219869|SUPERIORITY||Difference in percentage|11.87||||0.115|TWO_SIDED|95.0|-2.89|26.62|||Normal approximation to the binomial|||Week 40||26.62|-2.89|0.1150
71853016|NCT02592434|143219869|SUPERIORITY||Difference in percentage|13.29||||0.0744|TWO_SIDED|95.0|-1.31|27.9|||Normal approximation to the binomial|||Week 44||27.90|-1.31|0.0744
71853017|NCT02592434|143219871|SUPERIORITY||Difference in percentage|-16.15||||0.0207|TWO_SIDED|95.0|-29.84|-2.46|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||-2.46|-29.84|0.0207
71853018|NCT02592434|143219871|SUPERIORITY||Difference in percentage|10.63||||0.1254|TWO_SIDED|95.0|-2.97|24.24|||Normal approximation to the binomial|||Week 20||24.24|-2.97|0.1254
71853019|NCT02592434|143219871|SUPERIORITY||Difference in percentage|3.49||||0.635|TWO_SIDED|95.0|-10.93|17.91|||Normal approximation to the binomial|||Week 24||17.91|-10.93|0.6350
71853020|NCT02592434|143219871|SUPERIORITY||Difference in percentage|2.1||||0.7732|TWO_SIDED|95.0|-12.2|16.41|||Normal approximation to the binomial|||Week 28||16.41|-12.20|0.7732
71853021|NCT02592434|143219871|SUPERIORITY||Difference in percentage|6.35||||0.3782|TWO_SIDED|95.0|-7.77|20.47|||Normal approximation to the binomial|||Week 32||20.47|-7.77|0.3782
71853022|NCT02592434|143219871|SUPERIORITY||Difference in percentage|11.98||||0.0936|TWO_SIDED|95.0|-2.02|25.99|||Normal approximation to the binomial|||Week 36||25.99|-2.02|0.0936
71853023|NCT02592434|143219871|SUPERIORITY||Difference in percentage|9.17||||0.2017|TWO_SIDED|95.0|-4.91|23.24|||Normal approximation to the binomial|||Week 40||23.24|-4.91|0.2017
71853024|NCT02592434|143219871|SUPERIORITY||Difference in percentage|12.02||||0.0858|TWO_SIDED|95.0|-1.69|25.74|||Normal approximation to the binomial|||Week 44||25.74|-1.69|0.0858
71903309|NCT06704178|143328519|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71821461|NCT01012973|143145250|SUPERIORITY_OR_OTHER||Difference in Least square (LS) means|-239.42|||<|0.0001|TWO_SIDED|95.0|-286.31|-192.53||As fixed sequence testing did reject nullhypothesis of change from baseline in BCVA until week 24, and this p-value was below significance level of two-sided \<.05, the fixed sequence testing did continue with next secondary endpoint.|ANCOVA|ANCOVA, stratified by region and baseline BCVA category, baseline central retinal thickness added as covariate.|The difference is calculated as Eylea minus Sham. A negative value indicates Eylea showed a higher reduction in change in central retinal thickness until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in central retinal thickness between Eylea and Sham. If primary efficacy was successful, secondary efficacy end points were to be tested in a pre-specified fixed sequence testing procedure. Change in central retinal thickness was to be tested at second place in this sequence.||-192.53|-286.31|<.0001
71821462|NCT01012973|143145251|SUPERIORITY_OR_OTHER||CMH adjusted Difference|-1.5||||0.5947|TWO_SIDED|95.0|-7.4|4.4||As fixed sequence testing did reject nullhypothesis of change from baseline in CRT until week 24, and this p-value was not below significance level of two-sided \<.05, the fixed sequence testing did end with this evaluation.|Cochran-Mantel-Haenszel|Cochrane-Mantel-Haenszel test, stratified by region and baseline BCVA category.||Nullhypothesis of no difference in development of neovascularizations between Eylea and Sham group was tested. (Any neovascularization)||4.4|-7.4|0.5947
71821463|NCT01012973|143145252|SUPERIORITY_OR_OTHER||Difference in LS means|4.2|||||TWO_SIDED|95.0|1.7|6.8|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||6.8|1.7|
71821464|NCT01012973|143145253|SUPERIORITY_OR_OTHER||Difference in LS Means|0.044|||||TWO_SIDED|95.0|-0.002|0.09|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.|||0.09|-0.002|
71821465|NCT01782326|143145261|NON_INFERIORITY_OR_EQUIVALENCE|Study was designed to have \>95% power to rule out a 1.15-fold increase in the rate exacerbations for QVA149 vs. salmeterol/fluticasone.|Rate Ratio|0.89|||||TWO_SIDED|95.0|0.83|0.96|||Generalized linear model||If the upper limit of the confidence interval was \<1.15 then non-inferiority of QVA149 compared to SFC could be claimed|||0.96|0.83|
71821466|NCT01782326|143145261|SUPERIORITY_OR_OTHER||Rate Ratio|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Generalized linear method||If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1.|||0.96|0.83|0.003
71821467|NCT01782326|143145262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Regression, Cox|||||0.91|0.78|<0.001
71821468|NCT01782326|143145263|SUPERIORITY_OR_OTHER||Rate Ratio|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.91|||Generalized linear model|||||0.91|0.75|<0.001
71821469|NCT01782326|143145264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.7|0.86|||Regression, Cox|||||0.86|0.70|<0.001
71821470|NCT01782326|143145269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.256|TWO_SIDED|95.0|0.74|1.08|||Regression, Cox|||||1.08|0.74|0.256
71821471|NCT01782326|143145270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.008|TWO_SIDED|95.0|0.69|0.95|||Regression, Cox|||||0.95|0.69|0.008
71821472|NCT01782326|143145271|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.046|TWO_SIDED|95.0|0.66|1.0|||Regression, Cox|||||1.00|0.66|0.046
71821473|NCT01782326|143145272|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.79|TWO_SIDED|95.0|0.38|2.1|||Regression, Cox|||||2.10|0.38|0.790
71821474|NCT04033991|143145297|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821475|NCT04033991|143145297|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821476|NCT04033991|143145298|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821477|NCT04033991|143145298|OTHER|||||||0.0068|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0068
71821478|NCT04033991|143145300|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821479|NCT04033991|143145300|OTHER|||||||0.0004|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0004
71821480|NCT04033991|143145301|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821481|NCT04033991|143145301|OTHER|||||||0.0014|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0014
71821482|NCT04033991|143145306|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821483|NCT04033991|143145306|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821484|NCT04033991|143145307|OTHER||||||<|0.0001|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||<0.0001
71821485|NCT04033991|143145307|OTHER|||||||0.0094|||||||Log Rank|||Data were compared statistically across all 3 categories (favorable, intermediate and poor).||||0.0094
71821486|NCT00738530|143145322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.336|TWO_SIDED|95.0|0.76|1.1|||Log Rank|||||1.10|0.76|0.3360
71821487|NCT00738530|143145324|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0004|TWO_SIDED|95.0|0.64|0.88|||Log Rank|||||0.88|0.64|0.0004
71821488|NCT00738530|143145325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0002|TWO_SIDED|95.0|0.62|0.86|||Log Rank|||||0.86|0.62|0.0002
71903310|NCT06704178|143328519|SUPERIORITY|||||||0.998326||||||Comparison at Month 3|t-test, 2 sided|||||||0.998326
71903311|NCT06704178|143328519|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
71903312|NCT06704178|143328519|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
71903313|NCT06704178|143328519|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
71903314|NCT06704178|143328520|SUPERIORITY|||||||0.999387||||||Comparison at Month 1|t-test, 2 sided|||||||0.999387
71903315|NCT06704178|143328520|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71903316|NCT06704178|143328520|SUPERIORITY||||||>|0.999999||||||Comparison at Month 3|t-test, 2 sided|||||||>0.999999
71903317|NCT06704178|143328520|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
71903318|NCT06704178|143328520|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
71903319|NCT06704178|143328520|SUPERIORITY|||||||0.998367||||||Comparison at Month 6|t-test, 2 sided|||||||0.998367
71903320|NCT06704178|143328521|SUPERIORITY|||||||0.999975||||||Comparison at Month 1|t-test, 2 sided|||||||0.999975
71903321|NCT06704178|143328521|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71903322|NCT06704178|143328521|SUPERIORITY|||||||0.999801||||||Comparison at Month 3|t-test, 2 sided|||||||0.999801
71903323|NCT06704178|143328521|SUPERIORITY|||||||0.999984||||||Comparison at Month 4|t-test, 2 sided|||||||0.999984
71903324|NCT06704178|143328521|SUPERIORITY|||||||0.960874||||||Comparison at Month 5|t-test, 2 sided|||||||0.960874
71688689|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.53|||t-test, 2 sided|||FVC Day 8 (0.25 hrs post-dose)||0.53|0.33|<0.0001
71903325|NCT06704178|143328521|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
71903326|NCT06704178|143328522|SUPERIORITY|||||||0.981906||||||Comparison at Month 1|t-test, 2 sided|||||||0.981906
71903327|NCT06704178|143328522|SUPERIORITY|||||||0.945027||||||Comparison at Month 2|t-test, 2 sided|||||||0.945027
71903328|NCT06704178|143328522|SUPERIORITY|||||||0.767795||||||Comparison at Month 3|t-test, 2 sided|||||||0.767795
71903329|NCT06704178|143328522|SUPERIORITY|||||||0.996139||||||Comparison at Month 4|t-test, 2 sided|||||||0.996139
71903330|NCT06704178|143328522|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
71903331|NCT06704178|143328522|SUPERIORITY|||||||0.998846||||||Comparison at Month 6|t-test, 2 sided|||||||0.998846
71903332|NCT06704178|143328523|SUPERIORITY|||||||0.55783||||||Comparison at Month 1|t-test, 2 sided|||||||0.55783
71903333|NCT06704178|143328523|SUPERIORITY|||||||0.987949||||||Comparison at Month 2|t-test, 2 sided|||||||0.987949
71903334|NCT06704178|143328523|SUPERIORITY|||||||0.576782||||||Comparison at Month 3|t-test, 2 sided|||||||0.576782
71903335|NCT06704178|143328523|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
71821489|NCT00738530|143145327|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||0.0023|TWO_SIDED|95.0|0.66|0.92|||Log Rank|||||0.92|0.66|0.0023
71903336|NCT06704178|143328523|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
71903337|NCT06704178|143328523|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
71903338|NCT06704178|143328524|SUPERIORITY|||||||0.795476||||||Comparison at Month 1|t-test, 2 sided|||||||0.795476
71903339|NCT06704178|143328524|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
71903340|NCT06704178|143328524|SUPERIORITY|||||||0.559556||||||Comparison at Month 3|t-test, 2 sided|||||||0.559556
71903341|NCT06704178|143328524|SUPERIORITY|||||||0.997753||||||Comparison at Month 4|t-test, 2 sided|||||||0.997753
71903342|NCT06704178|143328524|SUPERIORITY|||||||0.952378||||||Comparison at Month 5|t-test, 2 sided|||||||0.952378
71903343|NCT06704178|143328524|SUPERIORITY|||||||0.988108||||||Comparison at Month 6|t-test, 2 sided|||||||0.988108
71903344|NCT06704178|143328525|SUPERIORITY|||||||0.995367||||||Comparison at Month 1|t-test, 2 sided|||||||0.995367
71903345|NCT06704178|143328525|SUPERIORITY|||||||0.999779||||||Comparison at Month 2|t-test, 2 sided|||||||0.999779
71903346|NCT06704178|143328525|SUPERIORITY|||||||0.974102||||||Comparison at Month 3|t-test, 2 sided|||||||0.974102
71903347|NCT06704178|143328525|SUPERIORITY|||||||0.998665||||||Comparison at Month 4|t-test, 2 sided|||||||0.998665
71903348|NCT06704178|143328525|SUPERIORITY|||||||0.999816||||||Comparison at Month 5|t-test, 2 sided|||||||0.999816
71903349|NCT06704178|143328525|SUPERIORITY|||||||0.999567||||||Comparison at Month 6|t-test, 2 sided|||||||0.999567
71903350|NCT06704178|143328526|SUPERIORITY|||||||0.882016||||||Comparison at Month 1|t-test, 2 sided|||||||0.882016
71903351|NCT06704178|143328526|SUPERIORITY|||||||0.860406||||||Comparison at Month 2|t-test, 2 sided|||||||0.860406
71903352|NCT06704178|143328526|SUPERIORITY|||||||0.958944||||||Comparison at Month 3|t-test, 2 sided|||||||0.958944
71903353|NCT06704178|143328526|SUPERIORITY|||||||0.998816||||||Comparison at Month 4|t-test, 2 sided|||||||0.998816
71903354|NCT06704178|143328526|SUPERIORITY|||||||0.989226||||||Comparison at Month 5|t-test, 2 sided|||||||0.989226
71903355|NCT06704178|143328526|SUPERIORITY|||||||0.999296||||||Comparison at Month 6|t-test, 2 sided|||||||0.999296
71903356|NCT06704178|143328527|SUPERIORITY|||||||0.999975||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999975
71903357|NCT06704178|143328527|SUPERIORITY|||||||0.977286||||||Comparison at Month 2|t-test, 2 sided|||||||0.977286
71903358|NCT06704178|143328527|SUPERIORITY|||||||0.999||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999
71903359|NCT06704178|143328527|SUPERIORITY|||||||0.999984||||||Comparison at Month 4.|t-test, 2 sided|||||||0.999984
71903360|NCT06704178|143328527|SUPERIORITY|||||||0.986557||||||Comparison at Month 5.|t-test, 2 sided|||||||0.986557
71903361|NCT06704178|143328527|SUPERIORITY|||||||0.998367||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998367
71903362|NCT06704178|143328528|SUPERIORITY|||||||0.999851||||||Comparison at Month 1.|t-test, 2 sided|||||||0.999851
71903363|NCT06704178|143328528|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
71903364|NCT06704178|143328528|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
71903365|NCT06704178|143328528|SUPERIORITY|||||||0.998467||||||Comparison at Month 4.|t-test, 2 sided|||||||0.998467
71903366|NCT06704178|143328528|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
71903367|NCT06704178|143328528|SUPERIORITY|||||||0.998846||||||Comparison at Month 6.|t-test, 2 sided|||||||0.998846
71903368|NCT06704178|143328529|SUPERIORITY||||||>|0.999999||||||Comparison at Month 1.|t-test, 2 sided|||||||>0.999999
71903369|NCT06704178|143328529|SUPERIORITY|||||||0.999779||||||Comparison at Month 2.|t-test, 2 sided|||||||0.999779
71903370|NCT06704178|143328529|SUPERIORITY|||||||0.999801||||||Comparison at Month 3.|t-test, 2 sided|||||||0.999801
71903371|NCT06704178|143328529|SUPERIORITY|||||||0.963236||||||Comparison at Month 4.|t-test, 2 sided|||||||0.963236
71903372|NCT06704178|143328529|SUPERIORITY|||||||0.999816||||||Comparison at Month 5.|t-test, 2 sided|||||||0.999816
71903373|NCT06704178|143328529|SUPERIORITY|||||||0.737995||||||Comparison at Month 6.|t-test, 2 sided|||||||0.737995
71903374|NCT06704178|143328530|SUPERIORITY|||||||0.0003||||||Within-group analysis only.|t-test, 2 sided|||||||0.0003
71903375|NCT06704178|143328531|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
71903376|NCT06704178|143328532|SUPERIORITY|||||||0.2698||||||Within-group analysis only.|t-test, 2 sided|||||||0.2698
71903377|NCT06704178|143328533|SUPERIORITY|||||||0.2137||||||Within-group analysis only.|t-test, 2 sided|||||||0.2137
71903378|NCT06704178|143328534|SUPERIORITY|||||||0.8639||||||Within-group analysis only.|t-test, 2 sided|||||||0.8639
71903379|NCT06704178|143328535|SUPERIORITY|||||||0.239||||||Within-group analysis only.|t-test, 2 sided|||||||0.239
71903380|NCT06704178|143328536|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
71903381|NCT06704178|143328537|SUPERIORITY|||||||0.5738||||||Within-group analysis only.|t-test, 2 sided|||||||0.5738
71903382|NCT06704178|143328538|SUPERIORITY|||||||0.6088||||||Within-group analysis only.|t-test, 2 sided|||||||0.6088
71821490|NCT00738530|143145328|SUPERIORITY_OR_OTHER||Difference in response rates|19.9|||<|0.0001|TWO_SIDED|95.0|13.2|26.6|||Chi-squared|||||26.6|13.2|<.0001
71903383|NCT06704178|143328539|SUPERIORITY|||||||0.4942||||||Within-group analysis only.|t-test, 2 sided|||||||0.4942
71903384|NCT06704178|143328540|SUPERIORITY|||||||0.7419||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7419
71903385|NCT06704178|143328540|SUPERIORITY|||||||0.0033||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0033
71903386|NCT06704178|143328540|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
71903387|NCT06704178|143328541|SUPERIORITY|||||||0.7708||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7708
71903388|NCT06704178|143328541|SUPERIORITY|||||||0.239||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.239
71903389|NCT06704178|143328541|SUPERIORITY|||||||0.006||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.006
71903390|NCT06704178|143328542|SUPERIORITY|||||||0.0219||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
71903391|NCT06704178|143328542|SUPERIORITY|||||||0.0001||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0001
71903392|NCT06704178|143328542|SUPERIORITY||||||<|0.0001||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||<0.0001
71903393|NCT06704178|143328543|SUPERIORITY|||||||0.0695||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0695
71903394|NCT06704178|143328543|SUPERIORITY|||||||0.0124||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0124
71903395|NCT06704178|143328543|SUPERIORITY|||||||0.0016||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0016
71903396|NCT06704178|143328544|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903397|NCT06704178|143328544|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903398|NCT06704178|143328544|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903399|NCT06704178|143328544|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903400|NCT06704178|143328544|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903401|NCT06704178|143328544|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903402|NCT06704178|143328545|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903403|NCT06704178|143328545|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903404|NCT06704178|143328545|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903405|NCT06704178|143328545|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903406|NCT06704178|143328545|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903407|NCT06704178|143328545|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903408|NCT06704178|143328546|SUPERIORITY|||||||0.4598||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4598
71903409|NCT06704178|143328546|SUPERIORITY|||||||0.23||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.23
71903410|NCT06704178|143328546|SUPERIORITY|||||||0.0806||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0806
71903411|NCT06704178|143328546|SUPERIORITY|||||||0.0969||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0969
71903412|NCT06704178|143328546|SUPERIORITY|||||||0.6098||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
71903413|NCT06704178|143328546|SUPERIORITY|||||||0.0369||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0369
71903414|NCT06704178|143328547|SUPERIORITY|||||||0.0384||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0384
71903415|NCT06704178|143328547|SUPERIORITY|||||||0.6328||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6328
71903416|NCT06704178|143328547|SUPERIORITY|||||||0.0026||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0026
71903417|NCT06704178|143328547|SUPERIORITY|||||||0.0012||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0012
71903418|NCT06704178|143328547|SUPERIORITY|||||||0.0118||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0118
71903419|NCT06704178|143328547|SUPERIORITY|||||||0.0221||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0221
71903420|NCT06704178|143328548|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903421|NCT06704178|143328548|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903422|NCT06704178|143328548|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903423|NCT06704178|143328548|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903424|NCT06704178|143328548|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903425|NCT06704178|143328548|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903426|NCT06704178|143328549|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903427|NCT06704178|143328549|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903428|NCT06704178|143328549|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903429|NCT06704178|143328549|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903430|NCT06704178|143328549|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903431|NCT06704178|143328549|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903432|NCT06704178|143328550|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903433|NCT06704178|143328550|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903434|NCT06704178|143328550|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903435|NCT06704178|143328550|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903436|NCT06704178|143328550|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903437|NCT06704178|143328550|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903438|NCT06704178|143328551|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903439|NCT06704178|143328551|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903440|NCT06704178|143328551|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903441|NCT06704178|143328551|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903442|NCT06704178|143328551|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903443|NCT06704178|143328551|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903444|NCT06704178|143328552|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903445|NCT06704178|143328552|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903446|NCT06704178|143328552|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903447|NCT06704178|143328552|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903448|NCT06704178|143328552|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903449|NCT06704178|143328552|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903450|NCT06704178|143328553|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903451|NCT06704178|143328553|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903452|NCT06704178|143328553|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903453|NCT06704178|143328553|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903454|NCT06704178|143328553|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903455|NCT06704178|143328553|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903456|NCT06704178|143328554|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903457|NCT06704178|143328554|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903458|NCT06704178|143328554|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903459|NCT06704178|143328554|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903460|NCT06704178|143328554|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903461|NCT06704178|143328554|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903462|NCT06704178|143328555|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903463|NCT06704178|143328555|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903464|NCT06704178|143328555|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903465|NCT06704178|143328555|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903466|NCT06704178|143328555|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903467|NCT06704178|143328555|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853025|NCT02592434|143219873|SUPERIORITY||LS mean difference|-2.07|STANDARD_ERROR_OF_MEAN|0.78||0.0088|TWO_SIDED|95.0|-3.6|-0.53|||MMRM|||Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.53|-3.60|0.0088
71853026|NCT02592434|143219873|SUPERIORITY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|1.28||0.0054|TWO_SIDED|95.0|-6.17|-1.1|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.10|-6.17|0.0054
71853027|NCT02592434|143219873|SUPERIORITY||LS mean difference|-3.85|STANDARD_ERROR_OF_MEAN|1.25||0.0039|TWO_SIDED|95.0|-6.38|-1.32|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.32|-6.38|0.0039
71853028|NCT02592434|143219873|SUPERIORITY||LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.98||0.0022|TWO_SIDED|95.0|-5.3|-1.29|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.29|-5.30|0.0022
71853029|NCT02592434|143219873|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.57||0.0005|TWO_SIDED|95.0|-9.42|-3.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-3.00|-9.42|0.0005
71853030|NCT02592434|143219873|SUPERIORITY||LS mean difference|-6.26|STANDARD_ERROR_OF_MEAN|1.63||0.0006|TWO_SIDED|95.0|-9.6|-2.92|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-2.92|-9.60|0.0006
71853031|NCT02592434|143219873|SUPERIORITY||LS mean difference|-4.36|STANDARD_ERROR_OF_MEAN|1.27||0.0027|TWO_SIDED|95.0|-7.02|-1.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.71|-7.02|0.0027
71853032|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.76||0.0172|TWO_SIDED|95.0|-3.32|-0.33|||MMRM|||Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-0.33|-3.32|0.0172
71853033|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.21||0.0057|TWO_SIDED|95.0|-5.81|-1.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.01|-5.81|0.0057
71853034|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0038|TWO_SIDED|95.0|-5.94|-1.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.23|-5.94|0.0038
71903468|NCT06704178|143328556|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903469|NCT06704178|143328556|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903470|NCT06704178|143328556|SUPERIORITY|||||||0.3682||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3682
71903471|NCT06704178|143328556|SUPERIORITY|||||||0.6098||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6098
71903472|NCT06704178|143328556|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903473|NCT06704178|143328556|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853035|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-3.41|STANDARD_ERROR_OF_MEAN|1.01||0.002|TWO_SIDED|95.0|-5.47|-1.36|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.36|-5.47|0.0020
71853036|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-5.66|STANDARD_ERROR_OF_MEAN|1.52||0.0007|TWO_SIDED|95.0|-8.74|-2.57|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.57|-8.74|0.0007
71853037|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|1.49||0.0007|TWO_SIDED|95.0|-8.66|-2.58|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.58|-8.66|0.0007
71853038|NCT02592434|143219875|SUPERIORITY||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|1.25||0.0018|TWO_SIDED|95.0|-6.99|-1.82|||MMRM|||Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-1.82|-6.99|0.0018
71853039|NCT02592434|143219877|SUPERIORITY||Difference in percentage|1.47||||0.861|TWO_SIDED|95.0|-14.96|17.9|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||17.90|-14.96|0.8610
71853040|NCT02592434|143219877|SUPERIORITY||Difference in percentage|10.12||||0.2173|TWO_SIDED|95.0|-5.96|26.2|||Normal approximation to the binomial|||Week 20||26.20|-5.96|0.2173
71903474|NCT06704178|143328557|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903475|NCT06704178|143328557|SUPERIORITY|||||||0.5691||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5691
71903476|NCT06704178|143328557|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903477|NCT06704178|143328557|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903478|NCT06704178|143328557|SUPERIORITY|||||||0.6983||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
71903479|NCT06704178|143328557|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71821491|NCT04179461|143145333|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the CASI was captured at clinical visits. 3. A level of statistical significance was established at \< 0.05.||||||0.52||||||Change in CASI score from V1 to V3|Wilcoxon (Mann-Whitney)|||The modified CASI score incorporates key asthma outcomes such as symptoms, healthcare utilization, and medication dose.||||0.52
71821492|NCT04179461|143145334|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.45||||||The change in ACT score from V1 to V2 (the period between V1 and V2).|Wilcoxon (Mann-Whitney)|||||||0.45
71853041|NCT02592434|143219877|SUPERIORITY||Difference in percentage|12.94||||0.1135|TWO_SIDED|95.0|-3.08|28.96|||Normal approximation to the binomial|||Week 24||28.96|-3.08|0.1135
71853042|NCT02592434|143219877|SUPERIORITY||Difference in percentage|11.51||||0.161|TWO_SIDED|95.0|-4.58|27.6|||Normal approximation to the binomial|||Week 28||27.60|-4.58|0.1610
71853043|NCT02592434|143219877|SUPERIORITY||Difference in percentage|7.42||||0.3571|TWO_SIDED|95.0|-8.37|23.21|||Normal approximation to the binomial|||Week 32||23.21|-8.37|0.3571
71853044|NCT02592434|143219877|SUPERIORITY||Difference in percentage|14.44||||0.0716|TWO_SIDED|95.0|-1.27|30.16|||Normal approximation to the binomial|||Week 36||30.16|-1.27|0.0716
71853045|NCT02592434|143219877|SUPERIORITY||Difference in percentage|14.4||||0.0746|TWO_SIDED|95.0|-1.43|30.24|||Normal approximation to the binomial|||Week 40||30.24|-1.43|0.0746
71853046|NCT02592434|143219877|SUPERIORITY||Difference in percentage|14.37||||0.0773|TWO_SIDED|95.0|-1.57|30.3|||Normal approximation to the binomial|||Week 44||30.30|-1.57|0.0773
71853047|NCT02592434|143219879|SUPERIORITY||Difference in percentage|-3.06||||0.5131|TWO_SIDED|95.0|-12.21|6.1|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)||6.10|-12.21|0.5131
71853048|NCT02592434|143219879|SUPERIORITY||Difference in percentage|6.87||||0.0876|TWO_SIDED|95.0|-1.01|14.74|||Normal approximation to the binomial|||Week 20||14.74|-1.01|0.0876
71853049|NCT02592434|143219879|SUPERIORITY||Difference in percentage|6.79||||0.1561|TWO_SIDED|95.0|-2.59|16.16|||Normal approximation to the binomial|||Week 24||16.16|-2.59|0.1561
71853050|NCT02592434|143219879|SUPERIORITY||Difference in percentage|2.58||||0.5795|TWO_SIDED|95.0|-6.54|11.7|||Normal approximation to the binomial|||Week 28||11.70|-6.54|0.5795
71853051|NCT02592434|143219879|SUPERIORITY||Difference in percentage|5.4||||0.2435|TWO_SIDED|95.0|-3.67|14.47|||Normal approximation to the binomial|||Week 32||14.47|-3.67|0.2435
71853052|NCT02592434|143219879|SUPERIORITY||Difference in percentage|9.52||||0.0758|TWO_SIDED|95.0|-0.99|20.04|||Normal approximation to the binomial|||Week 36||20.04|-0.99|0.0758
71821493|NCT04179461|143145334|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data. Data for the c-ACT/ACT was captured at clinical visits and from monthly phone calls. Because c-ACT/ACT could vary through time, we calculated the average c-ACT/ACT between V1-V2 and V2-V3. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.01||||||The change in ACT score from V1-V2 to V2-V3.|Wilcoxon (Mann-Whitney)|||||||0.01
71853053|NCT02592434|143219879|SUPERIORITY||Difference in percentage|10.91||||0.0464|TWO_SIDED|95.0|0.17|21.65|||Normal approximation to the binomial|||Week 40||21.65|0.17|0.0464
71853054|NCT02592434|143219879|SUPERIORITY||Difference in percentage|8.06||||0.1634|TWO_SIDED|95.0|-3.27|19.38|||Normal approximation to the binomial|||Week 44||19.38|-3.27|0.1634
71853055|NCT02592434|143219880|SUPERIORITY||Difference in percentage|-17.42||||0.0062|TWO_SIDED|95.0|-29.88|-4.96|||Normal approximation to the binomial|||Double Blind baseline (Week 18)||-4.96|-29.88|0.0062
71853056|NCT02592434|143219880|SUPERIORITY||Difference in percentage|-0.44||||0.9427|TWO_SIDED|95.0|-12.34|11.47|||Normal approximation to the binomial|||Week 20||11.47|-12.34|0.9427
71853057|NCT02592434|143219880|SUPERIORITY||Difference in percentage|-0.6||||0.9308|TWO_SIDED|95.0|-14.03|12.84|||Normal approximation to the binomial|||Week 24||12.84|-14.03|0.9308
71853058|NCT02592434|143219880|SUPERIORITY||Difference in percentage|0.87||||0.8945|TWO_SIDED|95.0|-12.03|13.78|||Normal approximation to the binomial|||Week 28||13.78|-12.03|0.8945
71853059|NCT02592434|143219880|SUPERIORITY||Difference in percentage|2.22||||0.7455|TWO_SIDED|95.0|-11.2|15.64|||Normal approximation to the binomial|||Week 32||15.64|-11.20|0.7455
71853060|NCT02592434|143219880|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 36||22.72|-4.23|0.1787
71853061|NCT02592434|143219880|SUPERIORITY||Difference in percentage|12.1||||0.0695|TWO_SIDED|95.0|-0.97|25.17|||Normal approximation to the binomial|||Week 40||25.17|-0.97|0.0695
71853062|NCT02592434|143219880|SUPERIORITY||Difference in percentage|9.25||||0.1787|TWO_SIDED|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 44||22.72|-4.23|0.1787
71853063|NCT02592434|143219881|SUPERIORITY||Difference in percentage|-0.12||||0.9719|TWO_SIDED|95.0|-6.74|6.5|||Normal approximation to the binomial|||||6.50|-6.74|0.9719
71853064|NCT02592434|143219883|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.61||0.1595|TWO_SIDED|95.0|-2.08|0.35|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.35|-2.08|0.1595
71853065|NCT02592434|143219883|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.96||0.1421|TWO_SIDED|95.0|-3.32|0.48|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.48|-3.32|0.1421
71853066|NCT02592434|143219883|SUPERIORITY||LS Mean difference|-1.66|STANDARD_ERROR_OF_MEAN|0.83||0.0552|TWO_SIDED|95.0|-3.37|0.04|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-3.37|0.0552
71821494|NCT04179461|143145335|EQUIVALENCE|The Wilcoxon signed-rank test was employed for pairwise comparison between visits for continuous data and the Bowker's test was used to compare categorical FEV1-FVC data. Data analysis was performed in SAS version 9.4 (SAS, Cary, NC). A level of statistical significance was established at \< 0.05.||||||0.27||||||The Change in FEV1/FVC from Visit 1 to Visit 3|Wilcoxon (Mann-Whitney)|||||||0.27
71821495|NCT04179461|143145336|EQUIVALENCE|Intervention adherence and end of study adherence were each calculated based on the 30 days prior to end of intervention and V3, respectively, in order to assess a consistent timeframe. The paired Wilcoxon signed rank test was conducted to compare controller inhaler adherence during baseline, adherence intervention, and end of study.||||||0.17||||||Change between baseline (V1) to end of study (V3)|Wilcoxon (Mann-Whitney)|||||||0.17
71853067|NCT02592434|143219883|SUPERIORITY||LS Mean difference|-1.17|STANDARD_ERROR_OF_MEAN|0.63||0.0822|TWO_SIDED|95.0|-2.5|0.17|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.17|-2.50|0.0822
71853068|NCT02592434|143219883|SUPERIORITY||LS Mean difference|-3.98|STANDARD_ERROR_OF_MEAN|1.22||0.0041|TWO_SIDED|95.0|-6.53|-1.43|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.43|-6.53|0.0041
71853069|NCT02592434|143219883|SUPERIORITY||LS Mean difference|-3.57|STANDARD_ERROR_OF_MEAN|1.22||0.0085|TWO_SIDED|95.0|-6.12|-1.02|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-1.02|-6.12|0.0085
71853070|NCT02592434|143219883|SUPERIORITY||LS Mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.03||0.0384|TWO_SIDED|95.0|-4.36|-0.13|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-4.36|0.0384
71853071|NCT02592434|143219885|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.23||0.2595|TWO_SIDED|95.0|-0.72|0.19|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.19|-0.72|0.2595
71853072|NCT02592434|143219885|SUPERIORITY||LS Mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.37||0.0674|TWO_SIDED|95.0|-1.42|0.05|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.42|0.0674
71853073|NCT02592434|143219885|SUPERIORITY||LS Mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.49||0.058|TWO_SIDED|95.0|-1.93|0.03|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.93|0.0580
71853074|NCT02592434|143219885|SUPERIORITY||LS Mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.44||0.0751|TWO_SIDED|95.0|-1.67|0.08|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.08|-1.67|0.0751
71853075|NCT02592434|143219885|SUPERIORITY||LS Mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.43||0.0251|TWO_SIDED|95.0|-1.88|-0.13|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.13|-1.88|0.0251
71853076|NCT02592434|143219885|SUPERIORITY||LS Mean difference|-1.08|STANDARD_ERROR_OF_MEAN|0.49||0.0331|TWO_SIDED|95.0|-2.07|-0.09|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.09|-2.07|0.0331
71853077|NCT02592434|143219885|SUPERIORITY||LS Mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.42||0.0549|TWO_SIDED|95.0|-1.66|0.02|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-1.66|0.0549
71903480|NCT06704178|143328558|SUPERIORITY|||||||0.819||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
71821496|NCT04707391|143145342|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup A.|Difference in percentage of participants|0.2|||||TWO_SIDED|0.95|-4.38|3.5||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.50|-4.38|
71853078|NCT02592434|143219887|SUPERIORITY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.25||0.0353|TWO_SIDED|95.0|-1.04|-0.04|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.04|-1.04|0.0353
71853079|NCT02592434|143219887|SUPERIORITY||LS Mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.32||0.0094|TWO_SIDED|95.0|-1.47|-0.21|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.21|-1.47|0.0094
71853080|NCT02592434|143219887|SUPERIORITY||LS Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0065|TWO_SIDED|95.0|-1.36|-0.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.23|-1.36|0.0065
71853081|NCT02592434|143219887|SUPERIORITY||LS Mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27||0.0018|TWO_SIDED|95.0|-1.43|-0.34|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.43|0.0018
71853082|NCT02592434|143219887|SUPERIORITY||LS Mean difference|-1.42|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|-2.24|-0.61|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.61|-2.24|0.0010
71903481|NCT06704178|143328558|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71821497|NCT04707391|143145342|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for serogroup C.|Difference in percentage of participants|0.5|||||TWO_SIDED|0.95|-4.14|3.98||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.98|-4.14|
71821498|NCT04707391|143145342|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup W.|Difference in percentage of participants|1.6|||||TWO_SIDED|0.95|-2.73|4.89||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups W at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||4.89|-2.73|
71821499|NCT04707391|143145342|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers between MenABCWY group and MenACWY group was above -10% for each serogroup Y.|Difference in percentage of participants|0.6|||||TWO_SIDED|0.95|-3.93|3.91||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the second MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.91|-3.93|
71853083|NCT02592434|143219887|SUPERIORITY||LS Mean difference|-1.61|STANDARD_ERROR_OF_MEAN|0.4||0.0002|TWO_SIDED|95.0|-2.42|-0.81|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.81|-2.42|0.0002
71853084|NCT02592434|143219887|SUPERIORITY||LS Mean difference|-1.58|STANDARD_ERROR_OF_MEAN|0.43||0.0007|TWO_SIDED|95.0|-2.44|-0.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.71|-2.44|0.0007
71853085|NCT02592434|143219889|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0398|TWO_SIDED|95.0|-0.83|-0.02|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.02|-0.83|0.0398
71853086|NCT02592434|143219889|SUPERIORITY||LS Mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.28||0.0011|TWO_SIDED|95.0|-1.49|-0.39|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.39|-1.49|0.0011
71853087|NCT02592434|143219889|SUPERIORITY||LS mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.32||0.0131|TWO_SIDED|95.0|-1.47|-0.18|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.47|0.0131
71853088|NCT02592434|143219889|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.32||0.0039|TWO_SIDED|95.0|-1.62|-0.33|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.33|-1.62|0.0039
71853089|NCT02592434|143219889|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.29||0.0711|TWO_SIDED|95.0|-1.1|0.05|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.05|-1.10|0.0711
71853090|NCT02592434|143219889|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0658|TWO_SIDED|95.0|-1.3|0.04|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.04|-1.30|0.0658
71853091|NCT02592434|143219889|SUPERIORITY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.29||0.0154|TWO_SIDED|95.0|-1.31|-0.15|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.15|-1.31|0.0154
71853092|NCT02592434|143219891|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.4777|TWO_SIDED|95.0|-0.12|0.06|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.06|-0.12|0.4777
71853093|NCT02592434|143219891|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0779|TWO_SIDED|95.0|-0.16|0.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.16|0.0779
71853094|NCT02592434|143219891|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0324|TWO_SIDED|95.0|-0.19|-0.01|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.19|0.0324
71853095|NCT02592434|143219891|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.06||0.1061|TWO_SIDED|95.0|-0.2|0.02|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.02|-0.20|0.1061
71853096|NCT02592434|143219891|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0572|TWO_SIDED|95.0|-0.24|0.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.00|-0.24|0.0572
71903482|NCT06704178|143328558|SUPERIORITY|||||||0.5749||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.5749
71903483|NCT06704178|143328558|SUPERIORITY|||||||0.4873||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4873
71821500|NCT04707391|143145343|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in the 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup A.|Difference in percentage of participants|-2.5|||||TWO_SIDED|0.95|-5.59|0.47||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups A at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||0.47|-5.59|
71821501|NCT04707391|143145343|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup C.|Difference in percentage of participants|0.1|||||TWO_SIDED|0.95|-2.76|2.94||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups C at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.94|-2.76|
71853097|NCT02592434|143219891|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.06||0.0689|TWO_SIDED|95.0|-0.24|0.01|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.01|-0.24|0.0689
71853098|NCT02592434|143219891|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0292|TWO_SIDED|95.0|-0.22|-0.01|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.01|-0.22|0.0292
71853099|NCT02592434|143219893|SUPERIORITY||LS Mean Difference|3.79|STANDARD_ERROR_OF_MEAN|3.77||0.3179|TWO_SIDED|95.0|-3.72|11.31|||MMRM|||Global Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.31|-3.72|0.3179
71853100|NCT02592434|143219893|SUPERIORITY||LS mean difference|3.28|STANDARD_ERROR_OF_MEAN|4.27||0.4452|TWO_SIDED|95.0|-5.23|11.78|||MMRM|||Physical Functioning: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.78|-5.23|0.4452
71853101|NCT02592434|143219893|SUPERIORITY||LS mean difference|5.47|STANDARD_ERROR_OF_MEAN|4.76||0.2539|TWO_SIDED|95.0|-4.01|14.95|||MMRM|||Social Limitations: Emotional: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||14.95|-4.01|0.2539
71853102|NCT02592434|143219893|SUPERIORITY||LS mean difference|7.22|STANDARD_ERROR_OF_MEAN|5.56||0.1981|TWO_SIDED|95.0|-3.86|18.3|||MMRM|||Social Limitations: Physical Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||18.30|-3.86|0.1981
71853103|NCT02592434|143219893|SUPERIORITY||LS mean difference|8.26|STANDARD_ERROR_OF_MEAN|4.36||0.062|TWO_SIDED|95.0|-0.43|16.94|||MMRM|||Bodily Pain: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||16.94|-0.43|0.0620
71853104|NCT02592434|143219893|SUPERIORITY||LS mean difference|-3.43|STANDARD_ERROR_OF_MEAN|2.83||0.2291|TWO_SIDED|95.0|-9.06|2.2|||MMRM|||Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.20|-9.06|0.2291
71821502|NCT04707391|143145343|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup W.|Difference in percentage of participants|0.4|||||TWO_SIDED|0.95|-2.41|3.25||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroupsW at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||3.25|-2.41|
71853105|NCT02592434|143219893|SUPERIORITY||LS mean difference|-3.65|STANDARD_ERROR_OF_MEAN|3.9||0.353|TWO_SIDED|95.0|-11.43|4.13|||MMRM|||Global Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||4.13|-11.43|0.3530
71853106|NCT02592434|143219893|SUPERIORITY||LS mean difference|-3.47|STANDARD_ERROR_OF_MEAN|3.41||0.3114|TWO_SIDED|95.0|-10.26|3.32|||MMRM|||Mental Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||3.32|-10.26|0.3114
71903484|NCT06704178|143328558|SUPERIORITY|||||||0.9998||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9998
71903485|NCT06704178|143328558|SUPERIORITY|||||||0.819||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.819
71853107|NCT02592434|143219893|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|4.46||0.8736|TWO_SIDED|95.0|-8.18|9.61|||MMRM|||Self Esteem: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||9.61|-8.18|0.8736
71853108|NCT02592434|143219893|SUPERIORITY||LS mean difference|1.77|STANDARD_ERROR_OF_MEAN|2.48||0.4778|TWO_SIDED|95.0|-3.18|6.72|||MMRM|||General Health Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||6.72|-3.18|0.4778
71853109|NCT02592434|143219893|SUPERIORITY||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8909|TWO_SIDED|95.0|-0.28|0.25|||MMRM|||Change in Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||0.25|-0.28|0.8909
71903486|NCT06704178|143328559|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71680287|NCT02634268|142878509|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.13|TWO_SIDED|95.0|-2.12|0.26|||Mixed Models Analysis|Difference in average waist circumference at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.26|-2.12|0.13
71821503|NCT04707391|143145343|NON_INFERIORITY|Non-inferiority was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval(CI) for the difference in percenatge of participants achieving a 4-fold rise in hSBA titers (p\_MenABCWY- p\_MenACWY) is above -10% for serogroup Y.|Difference in percentage of participants|-0.8|||||TWO_SIDED|0.95|-3.62|2.09||||||To demonstrate the immunological non-inferiority of the MenABCWY vaccine, compared to MenACWY vaccine given to healthy participants, previously primed with a MenACWY vaccine, as measured by the percentages of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroups Y at 1 month after the first MenABCWY vaccination (0,6-months) and 1 month after the MenACWY vaccination (single dose).||2.09|-3.62|
71821504|NCT01438229|143145371|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71821505|NCT01163149|143145400|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-302.05||||0.0285|TWO_SIDED|95.0|-626.4|-59.2||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||PLP Change from Baseline to Week 24||-59.20|-626.40|0.0285
71821506|NCT01163149|143145401|SUPERIORITY|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-1.825||||0.0715|TWO_SIDED|95.0|-3.21|0.23||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group.|PPi Change from Baseline to Week 24||0.230|-3.210|0.0715
71821507|NCT01163149|143145403|SUPERIORITY||Hodges-Lehmann-Sen|-0.91||||0.3301|TWO_SIDED|95.0|-3.32|1.78||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total BMC Change from Baseline to Week 24||1.780|-3.320|0.3301
71821508|NCT01163149|143145403|SUPERIORITY||Hodges-Lehmann-Sen|1.33||||0.3827|TWO_SIDED|95.0|-1.36|3.12||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMC Change from Baseline to Week 24||3.120|-1.360|0.3827
71821509|NCT01163149|143145403|SUPERIORITY||Hodges-Lehmann-Sen|-77.1||||0.0485|TWO_SIDED|95.0|-917.44|-1.74||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMC Change from Baseline to Week 24||-1.740|-917.440|0.0485
71853110|NCT02592434|143219893|SUPERIORITY||LS mean difference|8.97|STANDARD_ERROR_OF_MEAN|5.81||0.127|TWO_SIDED|95.0|-2.61|20.55|||MMRM|||Emotional Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||20.55|-2.61|0.1270
71853111|NCT02592434|143219893|SUPERIORITY||LS mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.96||0.0944|TWO_SIDED|95.0|-14.62|1.18|||MMRM|||Time Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||1.18|-14.62|0.0944
71853112|NCT02592434|143219893|SUPERIORITY||LS mean difference|-8.6|STANDARD_ERROR_OF_MEAN|3.23||0.0095|TWO_SIDED|95.0|-15.03|-2.17|||MMRM|||Family Activities: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||-2.17|-15.03|0.0095
71853113|NCT02592434|143219893|SUPERIORITY||LS mean difference|2.59|STANDARD_ERROR_OF_MEAN|4.29||0.5474|TWO_SIDED|95.0|-5.96|11.14|||MMRM|||Family Cohesion: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||11.14|-5.96|0.5474
71821510|NCT01163149|143145404|SUPERIORITY||Hodges-Lehmann-Sen|-0.0125||||0.7357|TWO_SIDED|95.0|-0.04|0.039||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total Change from Baseline to Week 24||0.0390|-0.0400|0.7357
71821511|NCT01163149|143145404|SUPERIORITY||Hodges-Lehmann-Sen|0.0255||||0.2439|TWO_SIDED|95.0|-0.009|0.041||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMD Change from Baseline to Week 24||0.0410|-0.0090|0.2439
71821512|NCT01163149|143145404|SUPERIORITY||Hodges-Lehmann-Sen|-0.0315||||0.1222|TWO_SIDED|95.0|-0.059|0.012||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMD Change from Baseline to Week 24||0.0120|-0.0590|0.1222
71821513|NCT01163149|143145405|SUPERIORITY||Hodges-Lehmann-Sen|44.0||||0.1303|TWO_SIDED|95.0|-73.0|114.0||Two-sided with p-value threshold \<0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group|Week 24 Change from Baseline||114.0|-73.0|0.1303
71821514|NCT02806336|143145409|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||change in combined groups||||0.03
71821515|NCT02806336|143145410|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
71821516|NCT02806336|143145411|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||||||0.78
71821517|NCT02806336|143145412|SUPERIORITY|||||||0.03||||||change in functional gait analysis (FGA) in combined groups compared to baseline|t-test, 2 sided|||||||0.03
71853114|NCT02592434|143219893|SUPERIORITY||LS mean difference|3.48|STANDARD_ERROR_OF_MEAN|2.03||0.0902|TWO_SIDED|95.0|-0.56|7.52|||MMRM|||Physical Health Summary: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||7.52|-0.56|0.0902
71853115|NCT02592434|143219893|SUPERIORITY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|1.67||0.6539|TWO_SIDED|95.0|-4.07|2.57|||MMRM|||Psychosocial Health Summary : Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.||2.57|-4.07|0.6539
71821518|NCT02806336|143145413|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71821519|NCT02806336|143145414|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
71821520|NCT02806336|143145414|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71821521|NCT02806336|143145415|SUPERIORITY|||||||0.23|||||||t-test, 2 sided|||||||0.23
71821522|NCT00322868|143145444|SUPERIORITY_OR_OTHER|||||||0.2772|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum white cell count||||||0.2772
71821523|NCT00322868|143145445|SUPERIORITY_OR_OTHER|||||||0.2467|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count||||||0.2467
71821524|NCT00322868|143145446|SUPERIORITY_OR_OTHER|||||||0.0288|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in sputum percent neutrophils||||||0.0288
71821525|NCT00322868|143145447|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum active elastase||||||0.50
71821526|NCT00322868|143145448|SUPERIORITY_OR_OTHER|||||||0.62|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum TNFα||||||0.62
71821527|NCT00322868|143145449|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß||||||0.50
71821528|NCT00322868|143145450|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-6||||||0.55
71821529|NCT00322868|143145451|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-8||||||0.75
71853116|NCT02592434|143219895|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.1894|TWO_SIDED|95.0|-0.8|0.16|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.16|-0.80|0.1894
71821530|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-2.2|1.4||||||Unmasked minus masked||1.4|-2.2|
71821531|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-1.5|2.5||||||Unmasked minus masked||2.5|-1.5|
71821532|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-0.1|2.2||||||Unmasked minus masked||2.2|-0.1|
71821533|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|0.2|3.5||||||Unmasked minus masked||3.5|0.2|
71821534|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-3.3|1.2||||||Partial masked minus masked||1.2|-3.3|
71821535|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.9|1.1||||||Partial masked minus masked||1.1|-1.9|
71821536|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.9|2.7||||||Partial masked minus masked||2.7|-2.9|
71821537|NCT01155726|143145476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-1.1|1.9||||||Partial masked minus masked||1.9|-1.1|
71821538|NCT02459587|143145477|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person. VCL contacts with and without suicide ideation were combined, due to low counts.|Hazard Ratio (HR)|1.24|STANDARD_ERROR_OF_MEAN|0.222||0.33|TWO_SIDED|95.0|0.8|1.92||2-tailed P-value above was calculated from type III test.|Regression, Cox|Model was structured to allow multiple events per person. No covariates.|Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.218 (SEM=0.222)|||1.92|0.80|0.33
71821539|NCT02459587|143145478|SUPERIORITY|Survival analysis using start/stop counting method to identify time until event, structured to allow for multiple events per person.|Hazard Ratio (HR)|0.52|STANDARD_ERROR_OF_MEAN|0.153|<|0.0001|TWO_SIDED|95.0|0.38|0.7||All tests of significance were 2-tailed. P-value above is type III. No covariates.|Regression, Cox||Cox Proportional Hazards Model was structured to allow multiple events per person. No covariates. HR based on parameter estimate = -0.660 (SEM=0.153)|||0.70|0.38|<0.0001
71821540|NCT02459587|143145479|SUPERIORITY|Two binary variables were derived from Treatment Services Review responses to identify any general mental health service utilization, one binary variable for Baseline and another for any outpatient mental health service utilization at any time point in the 1 year follow-up period. The Baseline variable was included as a main-effects covariate.|Odds Ratio, log|1.146||||0.66|TWO_SIDED|95.0|0.604|2.176|||Regression, Logistic|Bivariate logistic, adjusted for (1) if any general outpatient mental heath visits at baseline (0) otherwise||||2.176|0.604|0.66
71821541|NCT02096081|143145486|NON_INFERIORITY_OR_EQUIVALENCE|"The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group. The hypothesis testing procedure to test the equivalence of the two products is as follows:~Ho (null): D ≤ -∆ OR D ≥ ∆ versus Ha (alternate): -∆ \< D \< ∆, where ∆ is the margin of equivalence = 0.15."|Difference in proportions of response|-3.5|||||TWO_SIDED|95.0|-7.5|0.6|||||If the confidence interval lies within the limits of ±0.15, then Ho is rejected in favor of Ha (i.e., equivalence of incobotulinumtoxinA and onabotulinumtoxinA can be concluded); otherwise, treatment equivalence cannot be concluded.|With assumptions of an alpha of 5%, an equivalence margin of 15% for each side, the real response rate expected as 90% for incobotulinumtoxinA and onabotulinumtoxinA at day 30 and a 1:1 allocation ratio, a total of 225 subjects were needed to achieve a statistical power of 90% in order to make an equivalence conclusion at day 30. Results are based on the Newcombe-Wilson confidence interval. To account for exclusions from the PPS of about 10%, approximately 250 subjects were enrolled.||0.6|-7.5|
71853117|NCT02592434|143219895|SUPERIORITY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.31||0.0026|TWO_SIDED|95.0|-1.56|-0.34|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.34|-1.56|0.0026
71853118|NCT02592434|143219895|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.31||0.0067|TWO_SIDED|95.0|-1.5|-0.25|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.50|0.0067
71903487|NCT06704178|143328559|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71688690|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.36|0.54|||t-test, 2 sided|||FVC Day 8 (1 hrs post-dose)||0.54|0.36|<0.0001
71821542|NCT02096081|143145487|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.3|||||TWO_SIDED|95.0|-12.1|1.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||1.5|-12.1|
71821543|NCT02096081|143145488|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-0.5|||||TWO_SIDED|95.0|-10.6|9.6|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.6|-10.6|
71821544|NCT02096081|143145489|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.2|||||TWO_SIDED|95.0|-17.4|7.1|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||7.1|-17.4|
71821545|NCT02096081|143145490|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.7|||||TWO_SIDED|95.0|-8.5|3.2|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||3.2|-8.5|
71821546|NCT02096081|143145491|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.8|||||TWO_SIDED|95.0|-11.0|5.3|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||5.3|-11.0|
71821547|NCT02096081|143145492|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.5|||||TWO_SIDED|95.0|-12.4|9.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||9.5|-12.4|
71821548|NCT02096081|143145493|NON_INFERIORITY_OR_EQUIVALENCE|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.9|||||TWO_SIDED|95.0|-14.4|10.7|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.||10.7|-14.4|
71821549|NCT01923428|143145528|SUPERIORITY||Risk Difference (RD)|27.0|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71821550|NCT02550873|143145529|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|0.72||0.0014|TWO_SIDED|90.0|1.1|3.5||a priori threshold for statistical significance = 0.10|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||"The sample size calculation was based on the following assumptions:~Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80%"||3.5|1.1|0.0014
71821551|NCT02550873|143145530|SUPERIORITY||Mean Difference (Net)|31.3|STANDARD_ERROR_OF_MEAN|8.42||0.0002|TWO_SIDED|90.0|17.4|45.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||45.1|17.4|0.0002
71821552|NCT02550873|143145531|SUPERIORITY||Mean Difference (Net)|93.5|STANDARD_ERROR_OF_MEAN|72.98||0.2032|TWO_SIDED|90.0|-27.7|214.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||214.7|-27.7|0.2032
71821553|NCT02550873|143145532|SUPERIORITY||Mean Difference (Net)|31.9|STANDARD_ERROR_OF_MEAN|46.33||0.4927|TWO_SIDED|90.0|-45.0|108.8||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||108.8|-45.0|0.4927
71903488|NCT06704178|143328559|SUPERIORITY|||||||0.8495||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8495
71903489|NCT06704178|143328559|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||>0.9999
71853119|NCT02592434|143219895|SUPERIORITY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.37||0.0091|TWO_SIDED|95.0|-1.73|-0.25|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.25|-1.73|0.0091
71853120|NCT02592434|143219895|SUPERIORITY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.28||0.0632|TWO_SIDED|95.0|-1.09|0.03|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||0.03|-1.09|0.0632
71853121|NCT02592434|143219895|SUPERIORITY||LS mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.32||0.0306|TWO_SIDED|95.0|-1.35|-0.07|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.07|-1.35|0.0306
71853122|NCT02592434|143219895|SUPERIORITY||LS mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0118|TWO_SIDED|95.0|-1.41|-0.18|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.||-0.18|-1.41|0.0118
71853123|NCT01469819|143219925|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71853124|NCT01469819|143219926|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71853125|NCT01469819|143219927|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71853126|NCT01469819|143219928|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71853127|NCT01403805|143219931|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Fisher's test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'|Fisher Exact|||The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||<0.001
71853128|NCT01403805|143219932|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Fisher Exact|||The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher's test.||||0.05
71853129|NCT03082196|143219937|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.037|TWO_SIDED|95.0|-1.9|-0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||-0.1|-1.9|0.037
71853130|NCT03082196|143219938|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.062|TWO_SIDED|95.0|-1.5|0.1|||t-test, 2 sided||The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a lower caries increment in the test varnish as compared to the standard varnish.|||0.1|-1.5|0.062
71903490|NCT06704178|143328559|SUPERIORITY|||||||0.1951||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1951
71853131|NCT03082196|143219939|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.11|TWO_SIDED|95.0|-0.5|0.1|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A negative value for the difference indicates a happier response in the test varnish as compared to the standard varnish."|||0.1|-0.5|0.11
71853132|NCT03082196|143219940|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided||"The direction of the comparison (difference) is the test varnish to the standard varnish. A positive value for the difference indicates an unhappier response in the test varnish as compared to the standard varnish."|||0.3|-0.2|0.74
71853133|NCT01695993|143219941|OTHER|Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.|Mean Difference (Net)|0.03|STANDARD_DEVIATION|1.9||0.05|TWO_SIDED|||||Not adjusted|ANCOVA|||||||.05
71853134|NCT04057937|143219942|SUPERIORITY||Percentage Difference:Apremilast-Placebo|37.4||||0.0003|TWO_SIDED|95.0|18.6|56.1||Two-sided 0.10 significant level|Chi-squared||Confidence Intervals calculated using the Wald method (normal approximation).|||56.1|18.6|0.0003
71853135|NCT02389725|143219996|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71853136|NCT02389725|143219997|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71853137|NCT02389725|143219998|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.67
71853138|NCT02389725|143219999|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71853139|NCT00724750|143220011|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.||||||0.6|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.|Mixed Models Analysis|||||||0.60
71853140|NCT00724750|143220012|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 5%/day.||||||0.19|TWO_SIDED|||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.|Mixed Models Analysis|||||||0.19
71853141|NCT00724750|143220014|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71853142|NCT00724750|143220015|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
71853143|NCT00724750|143220016|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71853144|NCT05319756|143220019|SUPERIORITY||Mean Difference (Final Values)|32.8|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|ONE_SIDED|95.0|26.1||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||26.1|<.0001
71853145|NCT05319756|143220019|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|4.46||0.1041|ONE_SIDED|95.0||1.7|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||1.7||0.1041
71903491|NCT06704178|143328559|SUPERIORITY|||||||0.0806||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.0806
71680288|NCT02634268|142878510|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.64|TWO_SIDED|95.0|-3.02|1.84|||Mixed Models Analysis|Difference in average 12 month systolic blood at 12 months between control and intervention groups|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||1.84|-3.02|0.64
71680289|NCT02634268|142878511|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.004|TWO_SIDED|95.0|-0.85|-0.17|||Mixed Models Analysis|Difference in average BMI at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.17|-0.85|0.004
71821554|NCT02550873|143145533|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.96||0.5835|TWO_SIDED|90.0|-2.2|4.3||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||4.3|-2.2|0.5835
71821555|NCT02550873|143145534|SUPERIORITY||Mean Difference (Net)|43.6|STANDARD_ERROR_OF_MEAN|102.28||0.6707|TWO_SIDED|90.0|-126.3|213.5||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||213.5|-126.3|0.6707
71821556|NCT02550873|143145535|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.91||0.52|TWO_SIDED|90.0|-4.4|1.9||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||1.9|-4.4|0.52
71821557|NCT02550873|143145536|OTHER|Correlation analysis||||||0.0001||||||This study was not powered to test hypotheses beyond the primary endpoint.|Pearson's correlation|||||||0.0001
71821558|NCT02550873|143145536|OTHER|Correlation analysis||||||0.0069|||||||Pearson's correlation|||This study was not powered to test hypotheses beyond the primary endpoint.||||0.0069
71821559|NCT02550873|143145537|SUPERIORITY|||||||0.4179||||||P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.4179
71821560|NCT02550873|143145537|SUPERIORITY|||||||0.2184||||||P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.2184
71821561|NCT02550873|143145538|SUPERIORITY|||||||0.7773||||||P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.7773
71821562|NCT02550873|143145538|SUPERIORITY|||||||0.5976||||||P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.5976
71821563|NCT02550873|143145539|SUPERIORITY|||||||0.29||||||P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.29
71821564|NCT02550873|143145540|SUPERIORITY|||||||0.0508||||||P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.0508
71821565|NCT02550873|143145541|SUPERIORITY|||||||0.6308||||||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.6308
71821566|NCT02550873|143145542|SUPERIORITY|||||||0.1846||||||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||||||0.1846
71821567|NCT02550873|143145543|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.31||0.7424|TWO_SIDED|90.0|-2.6|1.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.||||1.7|-2.6|0.7424
71903492|NCT06704178|143328560|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71821568|NCT02550873|143145553|SUPERIORITY||Mean Difference (Net)|114.6|STANDARD_DEVIATION|56.1||0.0416|TWO_SIDED|90.0|22.2|207.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.||||207.1|22.2|0.0416
71821569|NCT04320615|143145560|OTHER||Median Difference (Final Values)|-1.0||||0.36|TWO_SIDED|95.0|-2.5|0.0|||Van Elteren Test|||||0.0|-2.5|0.3600
71821570|NCT04320615|143145561|OTHER||Hazard Ratio (HR)|1.448||||0.0443|TWO_SIDED|95.0|1.01|2.08|||Log Rank|||||2.08|1.01|0.0443
71821571|NCT04320615|143145562|OTHER||Hazard Ratio (HR)|1.263||||0.082|TWO_SIDED|95.0|0.97|1.64|||Log Rank|||||1.64|0.97|0.0820
71821572|NCT04320615|143145563|OTHER||Hazard Ratio (HR)|1.35||||0.037|TWO_SIDED|95.0|1.02|1.79|||Log Rank|||||1.79|1.02|0.0370
71903493|NCT06704178|143328560|SUPERIORITY|||||||0.6983||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.6983
71903494|NCT06704178|143328560|SUPERIORITY|||||||0.1062||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1062
71821573|NCT04320615|143145564|OTHER||Weighted % difference|-6.2||||0.0996|TWO_SIDED|95.0|-13.8|1.4|||Cochran-Mantel-Haenszel|||||1.4|-13.8|0.0996
71821574|NCT04320615|143145564|OTHER||Weighted % difference|-8.9||||0.1355|TWO_SIDED|95.0|-20.7|3.0|||Cochran-Mantel-Haenszel|||||3.0|-20.7|0.1355
71821575|NCT04320615|143145565|OTHER||Median Difference (Final Values)|5.5||||0.3202|TWO_SIDED|95.0|-2.8|13.0|||Van Elteren test|||||13.0|-2.8|0.3202
71821576|NCT04320615|143145566|OTHER||Weighted % difference|-5.7||||0.1514|TWO_SIDED|95.0|-13.7|2.2|||Cochran-Mantel-Haenszel|||||2.2|-13.7|0.1514
71821577|NCT04320615|143145566|OTHER||Weighted % difference|-14.8||||0.029|TWO_SIDED|95.0|-28.6|-1.0|||Cochran-Mantel-Haenszel|||||-1.0|-28.6|0.0290
71821578|NCT04320615|143145567|OTHER||Median Difference (Final Values)|-5.8||||0.0454|TWO_SIDED|95.0|-15.0|2.9|||Van Elteren test|||||2.9|-15.0|0.0454
71821579|NCT04320615|143145568|OTHER||Median Difference (Final Values)|-1.0||||0.0548|TWO_SIDED|95.0|-2.0|0.5|||Van Elteren test|||||0.5|-2.0|0.0548
71821580|NCT04320615|143145569|OTHER||Hazard Ratio (HR)|0.79||||0.1627|TWO_SIDED|95.0|0.57|1.1|||Log Rank|||||1.10|0.57|0.1627
71821581|NCT04320615|143145570|OTHER||Weighted % difference|0.3||||0.941|TWO_SIDED|95.0|-7.6|8.2|||Cochran-Mantel-Haenszel|||||8.2|-7.6|0.9410
71821582|NCT04320615|143145571|OTHER||Hazard Ratio (HR)|1.307||||0.0528|TWO_SIDED|95.0|1.0|1.72|||Log Rank|||||1.72|1.00|0.0528
71821583|NCT04320615|143145572|OTHER||Median Difference (Final Values)|-1.5||||0.0477|TWO_SIDED|95.0|-9.0|0.5|||Van Elteren test|||||0.5|-9.0|0.0477
71821584|NCT01449721|143145573|SUPERIORITY_OR_OTHER|||||||0.064|||||||2-sample z-test|z-test for differences in proportions||Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.||||0.064
71821585|NCT01607411|143145596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.59|||<|0.0001|TWO_SIDED|95.0|3.6|7.58||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||7.58|3.60|<0.0001
71821586|NCT01607411|143145596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.36|||<|0.0001|TWO_SIDED|95.0|2.37|6.35||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||6.35|2.37|<0.0001
71821587|NCT01607411|143145596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.16||||0.0021|TWO_SIDED|95.0|1.17|5.15||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||5.15|1.17|0.0021
71821588|NCT01607411|143145597|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.23||||0.2225|TWO_SIDED|95.0|-0.76|3.22||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.22|-0.76|0.2225
71903495|NCT06704178|143328560|SUPERIORITY|||||||0.0333||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0333
71821589|NCT01607411|143145597|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.44||||0.0168|TWO_SIDED|95.0|0.44|4.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.||4.43|0.44|0.0168
71821590|NCT01607411|143145597|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.2||||0.2352|TWO_SIDED|95.0|-0.79|3.19||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||3.19|-0.79|0.2352
71821591|NCT01607411|143145598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|34.65|||<|0.0001|TWO_SIDED|95.0|30.07|39.24||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.24|30.07|<0.0001
71903496|NCT06704178|143328560|SUPERIORITY|||||||0.0734||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0734
71903497|NCT06704178|143328560|SUPERIORITY|||||||0.0219||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0219
71903498|NCT06704178|143328561|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903499|NCT06704178|143328561|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903500|NCT06704178|143328561|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903501|NCT06704178|143328561|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71821592|NCT01607411|143145598|SUPERIORITY_OR_OTHER||Adjusted Mean difference|34.86|||<|0.0001|TWO_SIDED|95.0|30.28|39.44||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||39.44|30.28|<0.0001
71821593|NCT01607411|143145598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|28.55|||<|0.0001|TWO_SIDED|95.0|23.97|33.13||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||33.13|23.97|< 0.0001
71821594|NCT01607411|143145598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.9292|TWO_SIDED|95.0|-4.79|4.38||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||4.38|-4.79|0.9292
71821595|NCT01607411|143145598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1||||0.0094|TWO_SIDED|95.0|1.52|10.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.69|1.52|0.0094
71821596|NCT01607411|143145598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.31||||0.0073|TWO_SIDED|95.0|1.72|10.89||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||10.89|1.72|0.0073
71821597|NCT01607411|143145599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.78|||<|0.0001|TWO_SIDED|95.0|0.58|0.98||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random factor|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.98|0.58|<0.0001
71821598|NCT01607411|143145599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.79|||<|0.0001|TWO_SIDED|95.0|0.58|0.99||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.99|0.58|<0.0001
71821599|NCT01607411|143145599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.29|0.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.69|0.29|< 0.0001
71821600|NCT01607411|143145599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.005||||0.9631|TWO_SIDED|95.0|-0.21|0.2||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.20|-0.21|0.9631
71821601|NCT01607411|143145599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29||||0.0047|TWO_SIDED|95.0|0.09|0.49||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.49|0.09|0.0047
71903502|NCT06704178|143328561|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903503|NCT06704178|143328561|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903504|NCT06704178|143328562|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903505|NCT06704178|143328562|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903506|NCT06704178|143328562|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903507|NCT06704178|143328562|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903508|NCT06704178|143328562|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903509|NCT06704178|143328562|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903510|NCT06704178|143328563|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903511|NCT06704178|143328563|SUPERIORITY|||||||0.982||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
71903512|NCT06704178|143328563|SUPERIORITY|||||||0.091||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.091
71903513|NCT06704178|143328563|SUPERIORITY|||||||0.4449||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
71821602|NCT01607411|143145599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels||0.50|0.10|0.0040
71821603|NCT02107443|143145600|SUPERIORITY||Mean Difference (Final Values)|3.59|||<|0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.0001
71821604|NCT02107443|143145601|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.041|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||0.041
71821605|NCT02107443|143145603|SUPERIORITY||Mean Difference (Final Values)|1.05||||0.03|TWO_SIDED|95.0|0.12|1.98|||Mixed Models Analysis|The above p-values is for 4-6 weeks.|The above values are for 4-6 weeks.|||1.98|0.12|0.03
71821606|NCT02107443|143145603|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.08|TWO_SIDED|95.0|-0.11|1.77|||Mixed Models Analysis|The above p-value is for is for 3 months.|The above values are for 3 months|||1.77|-0.11|.08
71821607|NCT02107443|143145603|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.2|TWO_SIDED|95.0|-0.36|1.59|||Mixed Models Analysis|The above p-value is for 6 months|The above values are for 6 months.|||1.59|-0.36|0.20
71821608|NCT03786094|143145636|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.445|TWO_SIDED|96.0|0.85|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.85|0.4450
71821609|NCT03786094|143145637|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6158|TWO_SIDED|96.0|0.81|1.41|||t-test, 2 sided||HR and associated 2-sided 96% CI are estimated by a Cox proportional hazards model stratified for randomization stratification factors including a fixed effect term for treatment arm.|||1.41|0.81|0.6158
71821610|NCT03786094|143145638|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6126|TWO_SIDED|99.9|0.66|1.77|||t-test, 2 sided|||||1.77|0.66|0.6126
71821611|NCT01706965|143145669|SUPERIORITY|||||||0.38|||||||ANOVA|||Univariate ANOVA, controlling for baseline PANSS total||||.38
71853146|NCT05319756|143220019|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|4.46||0.3373|ONE_SIDED|95.0||5.5|||Mixed Models Analysis|||"The primary analysis evaluated whether gabapentin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||5.5||0.3373
71853147|NCT05319756|143220019|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|ONE_SIDED|95.0||-6.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-6.3||<.0001
71853148|NCT05319756|143220019|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|3.64|<|0.0001|ONE_SIDED|95.0||-0.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μG ≤ 0.2(μC - 50) versus Ha: μC - μG \>0.2(μC - 50)"||-0.6||<0.0001
71853149|NCT05319756|143220019|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|4.0||0.0232|ONE_SIDED|95.0||9.6|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11"||9.6||0.0232
71821612|NCT01706965|143145670|SUPERIORITY|ANOVA, controlled for baseline MATRICS||||||0.99|||||||ANOVA|||||||.99
71821613|NCT01563978|143145671|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|2.93||||0.023|TWO_SIDED|95.0|0.4|5.45|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.45|0.40|0.023
71821614|NCT01563978|143145672|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|3.53|||<|0.001|TWO_SIDED|95.0|2.04|5.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||||5.03|2.04|<0.001
71821615|NCT01563978|143145673|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.3||||0.02|TWO_SIDED|95.0|0.53|6.08|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime SBP (Day 28)||6.08|0.53|0.020
71853150|NCT05319756|143220019|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|4.01||0.2767|ONE_SIDED|95.0||15.2|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether gabapentin (G) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μG - μP ≥ δ2 versus Ha: μG - μP \< δ2 where δ2 =11."||15.2||0.2767
71821616|NCT01563978|143145673|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.75|||<|0.001|TWO_SIDED|95.0|2.08|5.42|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean daytime DBP (Day 28)||5.42|2.08|<0.001
71821617|NCT01563978|143145673|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.07||||0.179|TWO_SIDED|95.0|-0.96|5.11|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time SBP (Day 28)||5.11|-0.96|0.179
71821618|NCT01563978|143145673|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.14|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean night-time DBP (Day 28)||5.14|1.13|0.002
71821619|NCT01563978|143145674|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.11||||0.024|TWO_SIDED|95.0|0.41|5.81|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake SBP (Day 28)||5.81|0.41|0.024
71853151|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|267.1|STANDARD_ERROR_OF_MEAN|83.688||0.0016|TWO_SIDED|90.0|128.8|405.4|||Mixed Models Analysis|||||405.4|128.8|0.0016
71853152|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|29.19|STANDARD_ERROR_OF_MEAN|83.688||0.7276|TWO_SIDED|90.0|-109.0|167.5|||Mixed Models Analysis|||||167.5|-109|0.7276
71853153|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|50.41|STANDARD_ERROR_OF_MEAN|83.785||0.5481|TWO_SIDED|90.0|-88.0|188.9|||Mixed Models Analysis|||||188.9|-88.0|0.5481
71853154|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|350.7|STANDARD_ERROR_OF_MEAN|84.023|<|0.0001|TWO_SIDED|90.0|211.8|489.5|||Mixed Models Analysis|||||489.5|211.8|<0.0001
71903514|NCT06704178|143328563|SUPERIORITY|||||||0.0204||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0204
71903515|NCT06704178|143328563|SUPERIORITY|||||||0.0256||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0256
71903516|NCT06704178|143328564|SUPERIORITY|||||||0.9821||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9821
71903517|NCT06704178|143328564|SUPERIORITY|||||||0.0403||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0403
71903518|NCT06704178|143328564|SUPERIORITY|||||||0.0638||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.0638
71903519|NCT06704178|143328564|SUPERIORITY|||||||0.7195||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.7195
71853155|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|364.4|STANDARD_ERROR_OF_MEAN|83.785|<|0.0001|TWO_SIDED|90.0|225.9|502.8|||Mixed Models Analysis|||||502.8|225.9|<0.0001
71853156|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|-238.0|STANDARD_ERROR_OF_MEAN|83.785||0.005|TWO_SIDED|90.0|-376.0|-99.4|||Mixed Models Analysis|||||-99.4|-376|0.0050
71903520|NCT06704178|143328564|SUPERIORITY|||||||0.1856||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1856
71903521|NCT06704178|143328564|SUPERIORITY|||||||0.1222||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.1222
71903522|NCT06704178|143328565|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903523|NCT06704178|143328565|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903524|NCT06704178|143328565|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within group analysis only.||||||>0.9999
71903525|NCT06704178|143328565|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903526|NCT06704178|143328565|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853157|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|-217.0|STANDARD_ERROR_OF_MEAN|84.023||0.0106|TWO_SIDED|90.0|-356.0|-77.8|||Mixed Models Analysis|||||-77.8|-356|0.0106
71903527|NCT06704178|143328565|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903528|NCT06704178|143328566|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903529|NCT06704178|143328566|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903530|NCT06704178|143328566|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903531|NCT06704178|143328566|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853158|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|83.6|STANDARD_ERROR_OF_MEAN|83.785||0.3196|TWO_SIDED|90.0|-54.9|222.1|||Mixed Models Analysis|||||222.1|-54.9|0.3196
71853159|NCT05319756|143220021|OTHER||Mean Difference (Final Values)|97.29|STANDARD_ERROR_OF_MEAN|83.688||0.2464|TWO_SIDED|90.0|-41.0|235.6|||Mixed Models Analysis|||||235.6|-41.0|0.2464
71853160|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|64.67|STANDARD_ERROR_OF_MEAN|7.581|<|0.0001|TWO_SIDED|90.0|52.15|77.2|||Mixed Models Analysis|||||77.20|52.15|<.0001
71853161|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|7.581||0.0546|TWO_SIDED|90.0|2.13|27.1|||Mixed Models Analysis|||||27.1|2.13|0.0546
71853162|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|11.58|STANDARD_ERROR_OF_MEAN|7.589||0.1286|TWO_SIDED|90.0|-0.96|24.12|||Mixed Models Analysis|||||24.12|-0.96|0.1286
71853163|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|68.99|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|56.42|81.57|||Mixed Models Analysis|||||81.57|56.42|<.0001
71853164|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|76.37|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|63.83|88.91|||Mixed Models Analysis|||||88.91|63.83|<.0001
71853165|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|7.589|<|0.0001|TWO_SIDED|90.0|-62.6|-37.5|||Mixed Models Analysis|||||-37.5|-62.6|<.0001
71903532|NCT06704178|143328566|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903533|NCT06704178|143328566|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903534|NCT06704178|143328567|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903535|NCT06704178|143328567|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903536|NCT06704178|143328567|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903537|NCT06704178|143328567|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903538|NCT06704178|143328567|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71680290|NCT02634268|142878512|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.09|TWO_SIDED|95.0|-4.87|0.36|||Mixed Models Analysis|Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.||Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|0.36|-4.87|0.09
71853166|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|-53.1|STANDARD_ERROR_OF_MEAN|7.611|<|0.0001|TWO_SIDED|90.0|-65.7|-40.5|||Mixed Models Analysis|||||-40.5|-65.7|<.0001
71853167|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|7.589||0.5699|TWO_SIDED|90.0|-8.22|16.86|||Mixed Models Analysis|||||16.86|-8.22|0.5699
71853168|NCT05319756|143220027|OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|7.581||0.1243|TWO_SIDED|90.0|-0.83|24.23|||Mixed Models Analysis|||||24.23|-0.83|0.1243
71853169|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|286.7|STANDARD_ERROR_OF_MEAN|50.879|<|0.0001|TWO_SIDED|90.0|202.6|370.8|||Mixed Models Analysis|||||370.8|202.6|<.0001
71853170|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|53.85|STANDARD_ERROR_OF_MEAN|50.879||0.2912|TWO_SIDED|90.0|-30.2|137.9|||Mixed Models Analysis|||||137.9|-30.2|0.2912
71853171|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|97.8|STANDARD_ERROR_OF_MEAN|50.938||0.0563|TWO_SIDED|90.0|13.62|182.0|||Mixed Models Analysis|||||182.0|13.62|0.0563
71853172|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|484.5|STANDARD_ERROR_OF_MEAN|51.083|<|0.0001|TWO_SIDED|90.0|400.1|569.0|||Mixed Models Analysis|||||569.0|400.1|<.0001
71853173|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|396.6|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|312.4|480.8|||Mixed Models Analysis|||||480.8|312.4|<.0001
71853174|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|-233.0|STANDARD_ERROR_OF_MEAN|50.938|<|0.0001|TWO_SIDED|90.0|-317.0|-149.0|||Mixed Models Analysis|||||-149|-317|<.0001
71853175|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|-189.0|STANDARD_ERROR_OF_MEAN|51.083||0.0003|TWO_SIDED|90.0|-273.0|-105.0|||Mixed Models Analysis|||||-105|-273|0.0003
71853176|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|197.8|STANDARD_ERROR_OF_MEAN|50.938||0.0001|TWO_SIDED|90.0|113.7|282.0|||Mixed Models Analysis|||||282.0|113.7|0.0001
71903539|NCT06704178|143328567|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853177|NCT05319756|143220029|OTHER||Mean Difference (Final Values)|109.9|STANDARD_ERROR_OF_MEAN|50.879||0.032|TWO_SIDED|90.0|25.8|194.0|||Mixed Models Analysis|||||194.0|25.80|0.0320
71853178|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|18.73|STANDARD_ERROR_OF_MEAN|2.276|<|0.0001|TWO_SIDED|90.0|14.98|22.48|||Mixed Models Analysis|||||22.48|14.98|<0.0001
71903540|NCT06704178|143328568|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903541|NCT06704178|143328568|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853179|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.302||0.5056|TWO_SIDED|90.0|-2.03|5.56|||Mixed Models Analysis|||||5.56|-2.03|0.5056
71853180|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|4.62|STANDARD_ERROR_OF_MEAN|2.307||0.076|TWO_SIDED|90.0|0.82|8.42|||Mixed Models Analysis|||||8.42|0.82|0.0760
71853181|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|25.73|STANDARD_ERROR_OF_MEAN|2.315|<|0.0001|TWO_SIDED|90.0|21.92|29.54|||Mixed Models Analysis|||||29.54|21.92|<0.0001
71853182|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|24.42|STANDARD_ERROR_OF_MEAN|2.27|<|0.0001|TWO_SIDED|90.0|20.68|28.16|||Mixed Models Analysis|||||28.16|20.68|<0.0001
71853183|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|-17.0|STANDARD_ERROR_OF_MEAN|2.297|<|0.0001|TWO_SIDED|90.0|-20.8|-13.2|||Mixed Models Analysis|||||-13.2|-20.8|<0.0001
71853184|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|2.299|<|0.0001|TWO_SIDED|90.0|-17.9|-10.3|||Mixed Models Analysis|||||-10.3|-17.9|<0.0001
71853185|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.298||0.0024|TWO_SIDED|90.0|3.22|10.79|||Mixed Models Analysis|||||10.79|3.22|0.0024
71853186|NCT05319756|143220030|OTHER||Mean Difference (Final Values)|5.69|STANDARD_ERROR_OF_MEAN|2.255||0.0118|TWO_SIDED|90.0|1.98|9.41|||Mixed Models Analysis|||||9.41|1.98|0.0118
71853187|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|20.31|STANDARD_ERROR_OF_MEAN|2.246|<|0.0001|TWO_SIDED|90.0|16.61|24.01|||Mixed Models Analysis|||||24.01|16.61|<0.0001
71853188|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|2.65|STANDARD_ERROR_OF_MEAN|2.271||0.2439|TWO_SIDED|90.0|-1.09|6.39|||Mixed Models Analysis|||||6.39|-1.09|0.2439
71853189|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|2.276||0.0044|TWO_SIDED|90.0|2.75|10.25|||Mixed Models Analysis|||||10.25|2.75|0.0044
71853190|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|24.15|STANDARD_ERROR_OF_MEAN|2.284|<|0.0001|TWO_SIDED|90.0|20.39|27.91|||Mixed Models Analysis|||||27.91|20.39|<0.0001
71853191|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|28.19|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|24.5|31.88|||Mixed Models Analysis|||||31.88|24.50|<0.0001
71853192|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.266|<|0.0001|TWO_SIDED|90.0|-21.4|-13.9|||Mixed Models Analysis|||||-13.9|-21.4|<0.0001
71853193|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|2.268|<|0.0001|TWO_SIDED|90.0|-17.5|-10.1|||Mixed Models Analysis|||||-10.1|-17.5|<0.0001
71853194|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|3.84|STANDARD_ERROR_OF_MEAN|2.267||0.0907|TWO_SIDED|90.0|0.11|7.57|||Mixed Models Analysis|||||7.57|0.11|0.0907
71853195|NCT05319756|143220031|OTHER||Mean Difference (Final Values)|7.88|STANDARD_ERROR_OF_MEAN|2.225||0.0004|TWO_SIDED|90.0|4.22|11.55|||Mixed Models Analysis|||||11.55|4.22|0.0004
71853196|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|25.37|STANDARD_ERROR_OF_MEAN|1.528|<|0.0001|TWO_SIDED|90.0|22.86|27.88|||Mixed Models Analysis|||||27.88|22.86|<0.0001
71903542|NCT06704178|143328568|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903543|NCT06704178|143328568|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71821620|NCT01563978|143145674|SUPERIORITY_OR_OTHER||Least square means treatment difference|3.66|||<|0.001|TWO_SIDED|95.0|2.1|5.22|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean awake DBP (Day 28)||5.22|2.10|<0.001
71821621|NCT01563978|143145675|SUPERIORITY_OR_OTHER||Least squares mean treatment difference|1.99||||0.223|TWO_SIDED|95.0|-1.22|5.2|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping SBP||5.20|-1.22|0.223
71821622|NCT01563978|143145675|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.87||||0.007|TWO_SIDED|95.0|0.81|4.93|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in mean sleeping DBP||4.93|0.81|0.007
71821623|NCT01563978|143145676|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.24||||0.2|TWO_SIDED|95.0|-1.2|5.69|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic SBP (Day 29)||5.69|-1.20|0.200
71821624|NCT01563978|143145676|SUPERIORITY_OR_OTHER||Least square means treatment difference|2.36||||0.046|TWO_SIDED|95.0|0.05|4.68|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in clinic DBP (Day 29)||4.68|0.05|0.046
71853197|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.529||0.0189|TWO_SIDED|90.0|1.08|6.11|||Mixed Models Analysis|||||6.11|1.08|0.0189
71853198|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|6.18|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|3.66|8.71|||Mixed Models Analysis|||||8.71|3.66|<0.0001
71853199|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|32.18|STANDARD_ERROR_OF_MEAN|1.537|<|0.0001|TWO_SIDED|90.0|29.65|34.71|||Mixed Models Analysis|||||34.71|29.65|<0.0001
71853200|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|30.17|STANDARD_ERROR_OF_MEAN|1.525|<|0.0001|TWO_SIDED|90.0|27.66|32.68|||Mixed Models Analysis|||||32.68|27.66|<0.0001
71853201|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.522|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<0.0001
71853202|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|90.0|-21.7|-16.7|||Mixed Models Analysis|||||-16.7|-21.7|<0.0001
71853203|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|6.81|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|4.3|9.31|||Mixed Models Analysis|||||9.31|4.30|<0.0001
71853204|NCT05319756|143220032|OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|1.514||0.0015|TWO_SIDED|90.0|2.31|7.29|||Mixed Models Analysis|||||7.29|2.31|0.0015
71821625|NCT01563978|143145677|SUPERIORITY_OR_OTHER||Least square means treatment difference|6.31|||<|0.001|TWO_SIDED|95.0|3.6|9.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home SBP (Week 4)||9.03|3.60|<0.001
71821626|NCT01563978|143145677|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.58|||<|0.001|TWO_SIDED|95.0|2.91|6.25|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home DBP (Week 4)||6.25|2.91|<0.001
71821627|NCT01563978|143145678|SUPERIORITY_OR_OTHER||Least square means treatment difference|7.22|||<|0.001|TWO_SIDED|95.0|4.29|10.16|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home SBP (Week 4)||10.16|4.29|<0.001
71853205|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001|TWO_SIDED|90.0|3.01|5.45|||Mixed Models Analysis|||||5.45|3.01|<.0001
71853206|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|0.63|STANDARD_ERROR_OF_MEAN|0.743||0.3933|TWO_SIDED|90.0|-0.59|1.86|||Mixed Models Analysis|||||1.86|-0.59|0.3933
71853207|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|0.79|STANDARD_ERROR_OF_MEAN|0.747||0.2916|TWO_SIDED|90.0|-0.44|2.02|||Mixed Models Analysis|||||2.02|-0.44|0.2916
71853208|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|3.92|STANDARD_ERROR_OF_MEAN|0.748|<|0.0001|TWO_SIDED|90.0|2.69|5.15|||Mixed Models Analysis|||||5.15|2.69|<.0001
71853209|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001|TWO_SIDED|90.0|2.0|4.44|||Mixed Models Analysis|||||4.44|2.00|<.0001
71853210|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|-3.59|STANDARD_ERROR_OF_MEAN|0.74|<|0.0001|TWO_SIDED|90.0|-4.81|-2.38|||Mixed Models Analysis|||||-2.38|-4.81|<.0001
71853211|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.744|<|0.0001|TWO_SIDED|90.0|-4.66|-2.22|||Mixed Models Analysis|||||-2.22|-4.66|<.0001
71853212|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.741||0.6765|TWO_SIDED|90.0|-1.53|0.91|||Mixed Models Analysis|||||0.91|-1.53|0.6765
71853213|NCT05319756|143220033|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|0.737||0.1712|TWO_SIDED|90.0|-2.22|0.2|||Mixed Models Analysis|||||0.20|-2.22|0.1712
71853214|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|24.7|STANDARD_ERROR_OF_MEAN|1.526|<|0.0001|TWO_SIDED|90.0|22.19|27.21|||Mixed Models Analysis|||||27.21|22.19|<.0001
71903544|NCT06704178|143328568|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903545|NCT06704178|143328568|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903546|NCT06704178|143328569|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903547|NCT06704178|143328569|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903548|NCT06704178|143328569|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903549|NCT06704178|143328569|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903550|NCT06704178|143328569|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903551|NCT06704178|143328569|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903552|NCT06704178|143328570|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903553|NCT06704178|143328570|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903554|NCT06704178|143328570|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71821628|NCT01563978|143145678|SUPERIORITY_OR_OTHER||Least square means treatment difference|4.74|||<|0.001|TWO_SIDED|95.0|2.9|6.59|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home DBP (Week 4)||6.59|2.90|<0.001
71903555|NCT06704178|143328570|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903556|NCT06704178|143328570|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903557|NCT06704178|143328570|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853215|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|2.87|STANDARD_ERROR_OF_MEAN|1.527||0.0606|TWO_SIDED|90.0|0.35|5.38|||Mixed Models Analysis|||||5.38|0.35|0.0606
71853216|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|1.534||0.0074|TWO_SIDED|90.0|1.59|6.64|||Mixed Models Analysis|||||6.64|1.59|0.0074
71903558|NCT06704178|143328571|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903559|NCT06704178|143328571|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903560|NCT06704178|143328571|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903561|NCT06704178|143328571|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903562|NCT06704178|143328571|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903563|NCT06704178|143328571|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903564|NCT06704178|143328572|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853217|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|30.58|STANDARD_ERROR_OF_MEAN|1.536|<|0.0001|TWO_SIDED|90.0|28.05|33.1|||Mixed Models Analysis|||||33.10|28.05|<.0001
71853218|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|29.99|STANDARD_ERROR_OF_MEAN|1.524|<|0.0001|TWO_SIDED|90.0|27.48|32.5|||Mixed Models Analysis|||||32.50|27.48|<.0001
71853219|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|-21.8|STANDARD_ERROR_OF_MEAN|1.521|<|0.0001|TWO_SIDED|90.0|-24.3|-19.3|||Mixed Models Analysis|||||-19.3|-24.3|<.0001
71853220|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|-20.6|STANDARD_ERROR_OF_MEAN|1.529|<|0.0001|TWO_SIDED|90.0|-23.1|-18.1|||Mixed Models Analysis|||||-18.1|-23.1|<.0001
71853221|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|5.88|STANDARD_ERROR_OF_MEAN|1.523||0.0001|TWO_SIDED|90.0|3.37|8.38|||Mixed Models Analysis|||||8.38|3.37|0.0001
71853222|NCT05319756|143220034|OTHER||Mean Difference (Final Values)|5.29|STANDARD_ERROR_OF_MEAN|1.513||0.0005|TWO_SIDED|90.0|2.8|7.78|||Mixed Models Analysis|||||7.78|2.80|0.0005
71853223|NCT01357564|143220091|SUPERIORITY||Mean Difference (Net)|-0.72||||0.02|TWO_SIDED|95.0|-1.23|-0.13|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.13|-1.23|.02
71853224|NCT01357564|143220092|SUPERIORITY||Mean Difference (Net)|-0.1||||0.03|TWO_SIDED|95.0|-0.14|-0.01|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.||-0.01|-0.14|.03
71853225|NCT00348283|143220100|SUPERIORITY_OR_OTHER|||||||0.056||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|Because of the hierarchical testing scheme used for testing the ranked secondary endpoints, alpha level of 0.05 was used at each stage of testing.||ITT population: all subjects randomized at Week 4 who had at least 1 dose of blinded therapy. The sample-size (placebo = 65 subjects; adalimumab = 65 subjects) for the primary efficacy analysis was calculated using 88% power at 0.05 alpha level based on the assumption that 25% and 5% of subjects were without mucosal ulceration at Week 12 in adalimumab 40 mg eow and placebo groups, respectively. However, subjects without mucosal ulceration at Screening were excluded from the primary analysis.||||0.056
71853226|NCT00348283|143220101|SUPERIORITY_OR_OTHER|||||||0.021||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||0.021
71853227|NCT00348283|143220102|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at Week 52 in the two treatment groups.||||<0.001
71853228|NCT00348283|143220103|SUPERIORITY_OR_OTHER|||||||0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 52 in the two treatment groups.||||0.001
71853229|NCT00348283|143220104|SUPERIORITY_OR_OTHER|||||||0.15||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at both Week 12 and Week 52 in the two treatment groups.||||0.150
71853230|NCT00348283|143220105|SUPERIORITY_OR_OTHER||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.||||<0.001
71853231|NCT04853394|143220127|SUPERIORITY||Risk Ratio (RR)|0.33|||<|0.01|TWO_SIDED|95.0|0.21|0.51|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.51|.21|<.01
71853232|NCT04853394|143220128|SUPERIORITY||Risk Ratio (RR)|0.67||||0.01|TWO_SIDED|95.0|0.46|0.97|||Mixed Models Analysis|Mixed effects modified Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.97|.46|.01
71853233|NCT04853394|143220129|SUPERIORITY||Risk Ratio (RR)|0.86||||0.01|TWO_SIDED|95.0|0.77|0.95|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 6-month follow-up|||.95|.77|.01
71853234|NCT04853394|143220129|SUPERIORITY||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|0.98|1.45|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||1.45|.98|.01
71853235|NCT04853394|143220132|SUPERIORITY||Risk Ratio (RR)|0.12||||0.01|TWO_SIDED|95.0|0.07|0.19|||Mixed Models Analysis|Mixed effects Poisson regression model with random intercepts for participant and network cluster|Effect of MASLIHAT vs. comparison TANSIHAT condition at 12-month follow-up|||.19|.07|.01
71853236|NCT01178281|143220171|OTHER|||||||1|||||||Fisher Exact|||||||1.000
71853237|NCT01178281|143220173|OTHER|||||||0.929|||||||Log Rank|||||||0.929
71853238|NCT04050722|143220192|SUPERIORITY||Adjusted Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|95.0|-0.08|-0.04||Analysis was performed using ANCOVA model with study product group, gender, and baseline MGI stratification (low/high) as factors and the baseline value as covariate.|ANCOVA|||||-0.04|-0.08|<0.0001
71853239|NCT05129592|143220214|SUPERIORITY||Mean Difference (Final Values)|15.71|STANDARD_ERROR_OF_MEAN|7.3||0.095|TWO_SIDED|95.0|-1.87|33.3||Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective control and Nicotine corrective with both components of coherence|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|||33.30|-1.87|0.095
71853240|NCT05129592|143220214|SUPERIORITY||Mean Difference (Final Values)|18.67|STANDARD_ERROR_OF_MEAN|7.3||0.022|TWO_SIDED|95.0|2.02|35.33||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective control to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with causal explanation and Nicotine corrective with both components of coherence||35.33|2.02|0.022
71853241|NCT05129592|143220214|SUPERIORITY||Mean Difference (Final Values)|3.69|STANDARD_ERROR_OF_MEAN|7.3||0.931|TWO_SIDED|95.0|-12.76|20.15||Sidak's adjustment for multiple comparisons|ANCOVA|Controlling for baseline nicotine misperception (df=4)|Comparing Nicotine corrective with reason for misperception to the Nicotine corrective with both components of coherence|Sidak's adjusted p-value contrasting marginal linear predictions for the Nicotine corrective with reason for misperception and Nicotine corrective with both components of coherence||20.15|-12.76|0.931
71853242|NCT05129592|143220215|SUPERIORITY||Odds Ratio (OR)|1.54||||0.402|TWO_SIDED|95.0|0.56|4.24|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||4.24|0.56|0.402
71903565|NCT06704178|143328572|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903566|NCT06704178|143328572|SUPERIORITY||||||>|0.9999||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853243|NCT05129592|143220215|SUPERIORITY||Odds Ratio (OR)|1.83||||0.292|TWO_SIDED|95.0|0.59|5.62|||Regression, Logistic||Odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the control condition/odds of believing e-cigarettes are somewhat or much less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||5.62|0.59|0.292
71853244|NCT05129592|143220215|SUPERIORITY||Odds Ratio (OR)|0.77||||0.571|TWO_SIDED|95.0|0.3|1.93|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs||1.93|0.30|0.571
71853245|NCT05129592|143220215|SUPERIORITY||Odds Ratio (OR)|1.98|STANDARD_ERROR_OF_MEAN|1.44||0.349|TWO_SIDED|95.0|0.47|8.26|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the control condition/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||8.26|0.47|0.349
71903567|NCT06704178|143328572|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903568|NCT06704178|143328572|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903569|NCT06704178|143328572|SUPERIORITY|||||||0.982||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.982
71903570|NCT06704178|143328573|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903571|NCT06704178|143328573|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71853246|NCT05129592|143220215|SUPERIORITY||Odds Ratio (OR)|1.76|STANDARD_ERROR_OF_MEAN|1.07||0.355|TWO_SIDED|95.0|0.53|5.81|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||5.81|0.53|0.355
71853247|NCT05129592|143220215|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.42||0.591|TWO_SIDED|95.0|0.24|2.25|||Regression, Logistic||Odds of believing e-cigarettes are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing e-cigarettes are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on e-cigarette relative harm beliefs controlling for baseline beliefs and e-cigarette use||2.25|0.24|0.591
71853248|NCT05129592|143220216|SUPERIORITY|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.99||0.98|TWO_SIDED|95.0|0.13|7.27|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|||7.27|0.13|0.980
71853249|NCT05129592|143220216|SUPERIORITY||Odds Ratio (OR)|0.47|STANDARD_ERROR_OF_MEAN|0.41||0.382|TWO_SIDED|95.0|0.09|2.56|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||2.56|0.09|0.382
71853250|NCT05129592|143220216|SUPERIORITY||Odds Ratio, log|0.83|STANDARD_ERROR_OF_MEAN|0.79||0.846|TWO_SIDED|95.0|0.13|5.23|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs||5.23|0.13|0.846
71853251|NCT05129592|143220216|SUPERIORITY||Odds Ratio (OR)|1.01|STANDARD_ERROR_OF_MEAN|1.05||0.99|TWO_SIDED|95.0|0.13|7.74|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the control condition/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||7.74|0.13|0.990
71853252|NCT05129592|143220216|SUPERIORITY||Odds Ratio (OR)|0.51|STANDARD_ERROR_OF_MEAN|0.46||0.458|TWO_SIDED|95.0|0.09|3.01|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||3.01|0.09|0.458
71853253|NCT05129592|143220216|SUPERIORITY||Odds Ratio (OR)|0.74|STANDARD_ERROR_OF_MEAN|0.7||0.754|TWO_SIDED|95.0|0.12|4.76|||Regression, Logistic||Odds of believing NRT is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing NRT is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on NRT relative harm beliefs controlling for NRT use||4.76|0.12|0.754
71853254|NCT05129592|143220217|SUPERIORITY||Odds Ratio, log|1.69|STANDARD_ERROR_OF_MEAN|0.78||0.256|TWO_SIDED|95.0|0.68|4.15|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||4.15|0.68|0.256
71853255|NCT05129592|143220217|SUPERIORITY||Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.43||0.961|TWO_SIDED|95.0|0.45|2.32|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||2.32|0.45|0.961
71853256|NCT05129592|143220217|SUPERIORITY||Odds Ratio (OR)|0.67|STANDARD_ERROR_OF_MEAN|0.28||0.345|TWO_SIDED|95.0|0.3|1.53|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs||1.53|0.30|0.345
71903572|NCT06704178|143328573|SUPERIORITY||||||>|0.9999||||||Month 3 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903573|NCT06704178|143328573|SUPERIORITY||||||>|0.9999||||||Month 4 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903574|NCT06704178|143328573|SUPERIORITY||||||>|0.9999||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903575|NCT06704178|143328573|SUPERIORITY||||||>|0.9999||||||Month 6 vs Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903576|NCT06704178|143328574|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903577|NCT06704178|143328574|SUPERIORITY|||||||0.9951||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9951
71903578|NCT06704178|143328574|SUPERIORITY|||||||0.999||||||Month 3 versus Baseline|t-test, 2 sided|Within-group analysis only.||||||0.999
71903579|NCT06704178|143328574|SUPERIORITY|||||||0.9913||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9913
71903580|NCT06704178|143328574|SUPERIORITY|||||||0.4517||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4517
71903581|NCT06704178|143328574|SUPERIORITY|||||||0.8187||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8187
71903582|NCT06704178|143328575|SUPERIORITY|||||||0.998||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.998
71903583|NCT06704178|143328575|SUPERIORITY|||||||0.9591||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9591
71903584|NCT06704178|143328575|SUPERIORITY|||||||0.9994||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9994
71903585|NCT06704178|143328575|SUPERIORITY|||||||0.9936||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9936
71903586|NCT06704178|143328575|SUPERIORITY|||||||0.8526||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.8526
71821629|NCT01563978|143145680|SUPERIORITY_OR_OTHER||Least square means treatment difference|0.74|||<|0.001|TWO_SIDED|95.0|0.4|1.08||Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug \& baseline antihypertensive use (factors)|ANCOVA|||Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.||1.08|0.40|<0.001
71821630|NCT00729690|143145681|SUPERIORITY_OR_OTHER|||||||0.4742||95.0|||||ANOVA|||For 1st 24 hours NRS AUC Pain scores||||0.4742
71821631|NCT00729690|143145682|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANOVA|||||||0.7596
71821632|NCT00729690|143145683|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||ANOVA|||||||0.4321
71821633|NCT00729690|143145684|SUPERIORITY_OR_OTHER|||||||0.9361||95.0|||||ANOVA|||||||0.9361
71821634|NCT03077620|143145741|SUPERIORITY||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.064||0.05|TWO_SIDED|95.0|-0.017|0.256||Poor sleepers compared to good sleepers with Compound Symmetry covariance structure. Mean difference is poor sleepers minus good sleepers.|Mixed Models Analysis|||||0.256|-0.017|0.05
71821635|NCT03077620|143145742|SUPERIORITY||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.078|0.087||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.087|-0.078|0.05
71903587|NCT06704178|143328575|SUPERIORITY|||||||0.4375||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4375
71903588|NCT06704178|143328576|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903589|NCT06704178|143328576|SUPERIORITY|||||||0.7477||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis.||||||0.7477
71903590|NCT06704178|143328576|SUPERIORITY|||||||0.297||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
71903591|NCT06704178|143328576|SUPERIORITY|||||||0.3503||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
71903592|NCT06704178|143328576|SUPERIORITY|||||||0.297||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.297
71903593|NCT06704178|143328576|SUPERIORITY|||||||0.4449||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.4449
71903594|NCT06704178|143328577|SUPERIORITY||||||>|0.9999||||||Month 1 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903595|NCT06704178|143328577|SUPERIORITY||||||>|0.9999||||||Month 2 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903596|NCT06704178|143328577|SUPERIORITY|||||||0.9188||||||Month 3 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.9188
71903597|NCT06704178|143328577|SUPERIORITY||||||>|0.9999||||||Month 4 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903598|NCT06704178|143328577|SUPERIORITY|||||||0.3503||||||Month 5 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||0.3503
71903599|NCT06704178|143328577|SUPERIORITY||||||>|0.9999||||||Month 6 versus Baseline.|t-test, 2 sided|Within-group analysis only.||||||>0.9999
71903600|NCT05138783|143328599|NON_INFERIORITY|Noninferiority in distance VA was declared if upper confidence limit was less than 0.05.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.004|||ONE_SIDED|95.0||0.0||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|||LSM results based on mixed effects repeated measures model with both fixed (lens, period, and sequence) and random (subject) effects. Difference = PRECISION1 minus BIOTRUE. Sign (either negative or positive) is retained with the rounded value.|||0.00||
71903601|NCT00078559|143328604|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.1|||||TWO_SIDED|95.0|0.01|0.34|||95% Confidence Interval|Exact Binomial||||0.34|0.01|
71903602|NCT00078559|143328605|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
71903603|NCT00078559|143328606|SUPERIORITY_OR_OTHER||Proportion with acute rejection|0.0|||||TWO_SIDED|95.0|0.0|0.7|||95% Confidence Interval|Exact Binomial||||0.7|0.0|
71903604|NCT00078559|143328609|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial||||0.3|0.0|
71903605|NCT00078559|143328610|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.3|||95% Confidence Interval|Exact Binomial for all participants (n=10)||||0.3|0.0|
71903606|NCT00078559|143328611|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
71903607|NCT00078559|143328611|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
71853257|NCT05129592|143220217|SUPERIORITY||Odds Ratio (OR)|1.56|STANDARD_ERROR_OF_MEAN|0.76||0.36|TWO_SIDED|95.0|0.6|4.04|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the control condition/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||4.04|0.60|0.360
71853258|NCT05129592|143220217|SUPERIORITY||Odds Ratio (OR)|1.14|STANDARD_ERROR_OF_MEAN|0.5||0.765|TWO_SIDED|95.0|0.48|2.7|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||2.70|0.48|0.765
71853259|NCT05129592|143220217|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.27||0.252|TWO_SIDED|95.0|0.25|1.43|||Regression, Logistic||Odds of believing VLNC are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing VLNC are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on VLNC relative harm beliefs controlling for baseline beliefs and VLNC use||1.43|0.25|0.252
71903608|NCT00078559|143328612|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.4|||95% Confidence Interval|Exact Binomial for Not Withdrawn Group||||0.4|0.0|
71821636|NCT03077620|143145742|SUPERIORITY||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.033||0.05|TWO_SIDED|95.0|-0.051|0.117||After corrected for multiple comparisons with Bonferroni test, treatment groups 1 and 2 compared to placebo with Compound Symmetry covariance structure. Mean difference is placebo minus treatment group.|Mixed Models Analysis|||||0.117|-0.051|0.05
71821637|NCT02036515|143145767|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.69|||<|0.001|TWO_SIDED|95.0|-0.87|-0.5|||Constrained longitudinal data analysis|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.50|-0.87|<0.001
71821638|NCT02036515|143145767|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.58|-0.95|<0.001
71821639|NCT02036515|143145768|SUPERIORITY_OR_OTHER||Difference in percentage|-5.7|||||TWO_SIDED|95.0|-16.5|5.2||||||||5.2|-16.5|
71821640|NCT02036515|143145768|SUPERIORITY_OR_OTHER||Difference in percentage|-3.3|||||TWO_SIDED|95.0|-14.1|7.6||||||||7.6|-14.1|
71821641|NCT02036515|143145769|SUPERIORITY_OR_OTHER||Difference in percentage|0.6|||||TWO_SIDED|95.0|-4.4|5.6||||||||5.6|-4.4|
71821642|NCT02036515|143145769|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-4.9|4.9||||||||4.9|-4.9|
71821643|NCT02036515|143145770|SUPERIORITY_OR_OTHER||Differenc in least squares means|-25.15|||<|0.001|TWO_SIDED|95.0|-32.76|-17.54|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-17.54|-32.76|<0.001
71821644|NCT02036515|143145770|SUPERIORITY_OR_OTHER||Difference in least squares means|-31.28|||<|0.001|TWO_SIDED|95.0|-38.9|-23.66|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-23.66|-38.90|<0.001
71821645|NCT02036515|143145771|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.03|||<|0.001|TWO_SIDED|95.0|-2.65|-1.4|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.40|-2.65|<0.001
71821646|NCT02036515|143145771|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.72|||<|0.001|TWO_SIDED|95.0|-2.35|-1.09|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.09|-2.35|<0.001
71821647|NCT02036515|143145772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.001|TWO_SIDED|95.0|1.74|5.72|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||5.72|1.74|<0.001
71821648|NCT02036515|143145772|SUPERIORITY_OR_OTHER||Difference in least squares means|4.43|||<|0.001|TWO_SIDED|95.0|2.44|8.02|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.||||8.02|2.44|<0.001
71821649|NCT02036515|143145773|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.93||||0.019|TWO_SIDED|95.0|-5.36|-0.49|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-0.49|-5.36|0.019
71821650|NCT02036515|143145773|SUPERIORITY_OR_OTHER||Difference in least squares means|-3.94||||0.002|TWO_SIDED|95.0|-6.39|-1.5|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication||||-1.50|-6.39|0.002
71821651|NCT02036515|143145774|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.76|||||TWO_SIDED|95.0|-0.98|-0.54||||||||-0.54|-0.98|
71821652|NCT02036515|143145774|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.83|||||TWO_SIDED|95.0|-1.05|-0.61||||||||-0.61|-1.05|
71821653|NCT02036515|143145775|SUPERIORITY_OR_OTHER||Difference in least squares means|-28.76|||||TWO_SIDED|95.0|-36.44|-21.09||||||||-21.09|-36.44|
71821654|NCT02036515|143145775|SUPERIORITY_OR_OTHER||Difference in least squares means|-29.58|||||TWO_SIDED|95.0|-37.3|-21.85||||||||-21.85|-37.30|
71821655|NCT02036515|143145776|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.51|||||TWO_SIDED|95.0|-3.43|-1.59||||||||-1.59|-3.43|
71903609|NCT00078559|143328612|SUPERIORITY_OR_OTHER||Exact Binomial|0.0|||||TWO_SIDED|95.0|0.0|0.8|||95% Confidence Interval|Exact Binomial for Withdrawn Group||||0.8|0.0|
71903610|NCT03725202|143328618|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|17.1|||=|0.0019|TWO_SIDED|95.0|6.3|27.8|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||27.8|6.3|=0.0019
71903611|NCT03725202|143328618|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|12.1|||=|0.0579|TWO_SIDED|95.0|-0.4|24.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||24.6|-0.4|=0.0579
71903612|NCT03725202|143328619|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.7|||<|0.0001|TWO_SIDED|95.0|11.3|30.2|||Cochran-Mantel-Haenszel||Response rate difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||30.2|11.3|<0.0001
71903613|NCT03725202|143328619|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|9.9|||=|0.0699|TWO_SIDED|95.0|-0.8|20.6|||Cochran-Mantel-Haenszel||Response rate difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||20.6|-0.8|=0.0699
71821656|NCT02036515|143145776|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.88|||||TWO_SIDED|95.0|-2.81|-0.95||||||||-0.95|-2.81|
71821657|NCT02036515|143145777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.63|||||TWO_SIDED|95.0|1.98|6.64||||||||6.64|1.98|
71821658|NCT02036515|143145777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.02|||||TWO_SIDED|95.0|2.22|7.28||||||||7.28|2.22|
71821659|NCT02036515|143145778|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.99|||||TWO_SIDED|95.0|-7.82|-2.15||||||||-2.15|-7.82|
71821660|NCT02036515|143145778|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.92|||||TWO_SIDED|95.0|-7.76|-2.07||||||||-2.07|-7.76|
71821661|NCT02036515|143145779|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.24|||||TWO_SIDED|95.0|-2.97|0.48||||||||0.48|-2.97|
71821662|NCT02036515|143145779|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.38|||||TWO_SIDED|95.0|-3.11|0.36||||||||0.36|-3.11|
71821663|NCT02036515|143145780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.99|||||TWO_SIDED|95.0|-2.82|0.84||||||||0.84|-2.82|
71821664|NCT02036515|143145780|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.85|||||TWO_SIDED|95.0|-2.69|0.99||||||||0.99|-2.69|
71821665|NCT02036515|143145781|SUPERIORITY_OR_OTHER||Difference in percent|-15.1|||||TWO_SIDED|95.0|-21.9|-9.4||||||||-9.4|-21.9|
71821666|NCT02036515|143145781|SUPERIORITY_OR_OTHER||Difference in percent|-14.4|||||TWO_SIDED|95.0|-21.3|-8.5||||||||-8.5|-21.3|
71821667|NCT02036515|143145782|SUPERIORITY_OR_OTHER||Difference in percentage|-29.0|||||TWO_SIDED|95.0|-38.3|-19.4||||||||-19.4|-38.3|
71821668|NCT02036515|143145782|SUPERIORITY_OR_OTHER||Difference in percentage|-28.1|||||TWO_SIDED|95.0|-37.5|-18.4||||||||-18.4|-37.5|
71821669|NCT02036515|143145786|SUPERIORITY_OR_OTHER||Difference in least squares means|12.75|||||TWO_SIDED|95.0|6.83|18.68||||||||18.68|6.83|
71821670|NCT02036515|143145786|SUPERIORITY_OR_OTHER||Difference in least squares means|11.91|||||TWO_SIDED|95.0|5.94|17.88||||||||17.88|5.94|
71821671|NCT02036515|143145787|SUPERIORITY_OR_OTHER||Difference in least squares means|12.78|||||TWO_SIDED|95.0|6.54|19.03||||||||19.03|6.54|
71821672|NCT02036515|143145787|SUPERIORITY_OR_OTHER||Difference in least squares means|12.86|||||TWO_SIDED|95.0|6.54|19.18||||||||19.18|6.54|
71821673|NCT02036515|143145789|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||||||||0.02|-0.04|
71821674|NCT02036515|143145789|SUPERIORITY_OR_OTHER||Difference in least squares means|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
71821675|NCT02036515|143145790|SUPERIORITY_OR_OTHER||Difference in least squares means|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||||0.04|-0.04|
71821676|NCT02036515|143145790|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.02|||||TWO_SIDED|95.0|-0.07|0.02||||||||0.02|-0.07|
71821677|NCT01053637|143145798|SUPERIORITY|||||||0.05||||||Pain at 5 minutes using Children's Hospital of Eastern Ontario Pain Scale validated in the younger population. Using a 2-point difference in CHEOPS pain scale as a clinically significant change, 34 patients were required in the younger 2- to 7 group.|Fisher Exact|||Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest or worst pain.||||0.05
71821678|NCT01053637|143145799|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||State-Trait Anxiety Inventory for Children pre vs. post procedure for matched pairs. Higher numbers indicated higher state anxiety. State Trait Anxiety Inventory for Children (STAIC) scores pre vs. post procedure for matched pairs. A lower STAIC score indicates less anxiety and a greater score indicates more anxiety based on Likert-type scales and analyzed using nonparametric testing.||||0.05
71821679|NCT02102464|143145813|SUPERIORITY||Mean Difference (Final Values)|11.0|||<|0.0001|TWO_SIDED|95.0|8.0|14.0|||t-test, 2 sided|||||14.0|8.0|<0.0001
71821680|NCT02102464|143145814|SUPERIORITY||Mean Difference (Final Values)|-7.7|||<|0.0001|TWO_SIDED|95.0|-10.2|-5.2|||t-test, 2 sided|||||-5.2|-10.2|<0.0001
71821681|NCT02102464|143145815|SUPERIORITY||Mean Difference (Final Values)|3.9|||<|0.0001|TWO_SIDED|95.0|2.5|5.4|||t-test, 2 sided|||||5.4|2.5|<0.0001
71903614|NCT03725202|143328620|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
71903615|NCT03725202|143328620|SUPERIORITY|P-value is based on the van Elteren test, adjusting for the strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease)).|||||<|0.0001|||||||van Elteren test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||||<0.0001
71903616|NCT03725202|143328621|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.57|||=|0.0025|TWO_SIDED|95.0|0.399|0.826|||Log-rank test|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.826|0.399|=0.0025
71903617|NCT03725202|143328621|SUPERIORITY|Treatment comparisons in the distribution of time-to-event between each upadacitinib group and the placebo are conducted using stratified log-rank test stratified by stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease). Within each stratum, 95% CI for difference are calculated using Cox proportional hazards model with stratification factors as covariates|Cox Proportional Hazard|0.75|||=|0.1778|TWO_SIDED|95.0|0.499|1.136|||Log-rank test|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.136|0.499|=0.1778
71821682|NCT01824472|143145834|SUPERIORITY||Mean difference compared across 3 groups|0.43||||0.8|TWO_SIDED||||||Kruskal-Wallis||"Kruskal-Wallis test implemented as PROC NPAR1WAY in Statistical Analysis System (SAS v9.4) for a single groupwise comparison. The mean difference (baseline to follow-up) was determined for each group, and this was compared across all 3 groups."|||||0.8
71821683|NCT01815736|143145835|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|2.7||||0.051|TWO_SIDED|95.01|-0.3|5.6||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.6|-0.3|0.051
71821684|NCT01815736|143145835|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|4.1|||<|0.001|TWO_SIDED|95.0|1.6|6.7||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|All Participants||6.7|1.6|<0.001
71821685|NCT01815736|143145836|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.078|||<|0.001|TWO_SIDED|95.0|1.697|2.459||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.459|1.697|<0.001
71821686|NCT01815736|143145836|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.807|||<|0.001|TWO_SIDED|95.0|1.488|2.126||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.126|1.488|<0.001
71821687|NCT01815736|143145837|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.97|||<|0.001|TWO_SIDED|95.0|1.551|2.39||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut||2.390|1.551|<0.001
71903618|NCT03725202|143328622|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.47|||=|0.0014|TWO_SIDED|95.0|0.29|0.74|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.74|0.29|=0.0014
71821688|NCT01815736|143145837|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|2.0|||<|0.001|TWO_SIDED|95.0|1.549|2.452||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants||2.452|1.549|<0.001
71821689|NCT01815736|143145838|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.03||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|NDA Data Cut||-0.03|-0.07|<0.001
71821690|NCT01815736|143145838|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.04|||<|0.001|TWO_SIDED|95.0|-0.05|-0.02||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|All Participants||-0.02|-0.05|<0.001
71821691|NCT01815736|143145839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||NDA Data Cut||||<0.001
71903619|NCT03725202|143328622|SUPERIORITY|The point estimate of flare rate at Week 52 from the Kaplan-Meier estimate for each stratum is used to derive the stratified disease flare rate. P-value, and 95% CI for the odds ratio between each upadacitinib group and placebo is also provided. Stratification factors (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤ 30 mg) and disease status (new onset or relapsing disease) were used.|Odds Ratio (OR)|0.6|||=|0.0633|TWO_SIDED|95.0|0.35|1.03|||Stratified Test for Odds Ratio|This method is described in J Immunother Cancer. 2021 Nov;9(11):e003323. doi: 10.1136/jitc-2021-003323.||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.03|0.35|=0.0633
71821692|NCT01815736|143145839|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||All Participants||||<0.001
71821693|NCT01815736|143145840|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.7||||0.017|TWO_SIDED|95.0|0.4|7.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||7.0|0.4|0.017
71853260|NCT05129592|143220218|SUPERIORITY||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.2||0.077|TWO_SIDED|95.0|0.18|1.09|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||1.09|0.18|0.077
71853261|NCT05129592|143220218|SUPERIORITY||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.4||0.853|TWO_SIDED|95.0|0.4|2.15|||Regression, Logistic|||Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs|Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|2.15|0.40|0.853
71853262|NCT05129592|143220218|SUPERIORITY||Odds Ratio, log|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|0.18|0.95|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with both components of coherence/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless tobacco relative harm beliefs||0.95|0.18|0.037
71853263|NCT05129592|143220218|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.33||0.349|TWO_SIDED|95.0|0.21|1.75|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the control condition/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.75|0.21|0.349
71853264|NCT05129592|143220218|SUPERIORITY||Odds Ratio (OR)|1.45|STANDARD_ERROR_OF_MEAN|0.74||0.464|TWO_SIDED|95.0|0.54|3.93|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||3.93|0.54|0.464
71903620|NCT03725202|143328623|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|30.3|||<|0.0001|TWO_SIDED|95.0|20.4|40.2|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||40.2|20.4|<0.0001
71821694|NCT01815736|143145841|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: The E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|1.8||||0.29|TWO_SIDED|95.0|-1.7|5.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|NDA Data Cut||5.3|-1.7|0.29
71853265|NCT05129592|143220218|SUPERIORITY||Odds Ratio (OR)|0.5|STANDARD_ERROR_OF_MEAN|0.26||0.187|TWO_SIDED|95.0|0.18|1.4|||Regression, Logistic||Odds of believing smokeless tobacco is less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing smokeless tobacco is less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on smokeless relative harm beliefs controlling for baseline beliefs and smokeless tobacco use||1.40|0.18|0.187
71853266|NCT05129592|143220219|SUPERIORITY||Odds Ratio (OR)|1.06|STANDARD_ERROR_OF_MEAN|0.66||0.925|TWO_SIDED|95.0|0.31|3.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||3.62|0.31|0.925
71853267|NCT05129592|143220219|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.43||0.525|TWO_SIDED|95.0|0.19|2.35|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.35|0.19|0.525
71853268|NCT05129592|143220219|SUPERIORITY||Odds Ratio (OR)|0.71|STANDARD_ERROR_OF_MEAN|0.44||0.586|TWO_SIDED|95.0|0.21|2.4|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Unadjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs||2.40|0.21|0.586
71853269|NCT05129592|143220219|SUPERIORITY||Odds Ratio (OR)|1.1|STANDARD_ERROR_OF_MEAN|0.71||0.883|TWO_SIDED|95.0|0.31|3.9|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the control condition/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective control compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||3.90|0.31|0.883
71853270|NCT05129592|143220219|SUPERIORITY||Odds Ratio (OR)|0.66|STANDARD_ERROR_OF_MEAN|0.44||0.534|TWO_SIDED|95.0|0.18|2.41|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with causal explanation/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with causal explanation compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.41|0.18|0.534
71853271|NCT05129592|143220219|SUPERIORITY||Odds Ratio (OR)|0.76|STANDARD_ERROR_OF_MEAN|0.48||0.661|TWO_SIDED|95.0|0.22|2.62|||Regression, Logistic||Odds of believing cigarillos are less harmful than cigarettes in the Nicotine corrective with reason for misperception/odds of believing cigarillos are less harmful than cigarettes in the condition with both component of coherence|Adjusted logistic regression showing the effect of condition (Nicotine corrective with reason for misperception compared to the Nicotine corrective with both components of coherence (reference group)) on cigarillo relative harm beliefs controlling for smokeless tobacco use||2.62|0.22|0.661
71903621|NCT03725202|143328623|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|23.5|||<|0.0001|TWO_SIDED|95.0|11.7|35.3|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||35.3|11.7|<0.0001
71903622|NCT03725202|143328624|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|20.8|||=|0.0002|TWO_SIDED|95.0|9.7|31.9|||Cochran-Mantel-Haenszel|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||31.9|9.7|=0.0002
71903623|NCT03725202|143328624|SUPERIORITY|Across the strata, 95% CI for adjusted difference and p-value are calculated according to the Cochran-Mantel-Haenszel test adjusted for strata (Baseline CS dose (prednisone or prednisolone \> 30 mg or ≤30 mg) and disease status (new onset or relapsing disease)) for the comparison of two treatment groups. Within each stratum, 95% CI for difference are calculated using normal approximation to the binomial distribution.|Adjusted Response Rate Difference|3.2|||=|0.6276|TWO_SIDED|95.0|-9.6|16.0|||Cochran-Mantel-Haenszel|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||16.0|-9.6|=0.6276
71903624|NCT03725202|143328625|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.7526|STANDARD_ERROR_OF_MEAN|1.1981|=|0.0019|TWO_SIDED|95.0|1.3932|6.1119|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib - Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.1119|1.3932|=0.0019
71903625|NCT03725202|143328625|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.6094|STANDARD_ERROR_OF_MEAN|1.4185|=|0.067|TWO_SIDED|95.0|-0.1841|5.4028|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib - Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||5.4028|-0.1841|=0.0670
71903626|NCT03725202|143328626|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.6||||0.001|TWO_SIDED|95.0|0.4|0.8|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||0.8|0.4|0.0010
71903627|NCT03725202|143328626|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.8|||=|0.2722|TWO_SIDED|95.0|0.6|1.2|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.2|0.6|=0.2722
71903628|NCT03725202|143328627|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.38|=|0.0036|TWO_SIDED|95.0|1.33|6.76|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.76|1.33|=0.0036
71903629|NCT03725202|143328627|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|1.63|=|0.0338|TWO_SIDED|95.0|0.27|6.7|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||6.70|0.27|=0.0338
71903630|NCT03725202|143328628|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|2.7325|STANDARD_ERROR_OF_MEAN|2.9635|=|0.3573|TWO_SIDED|95.0|-3.102|8.567|||Mixed-Effect Model Repeat Measurement||Difference = 15 mg Upadacitinib -Placebo|15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||8.5670|-3.1020|=0.3573
71903631|NCT03725202|143328628|SUPERIORITY|The Mixed-Effect Model Repeat Measurement with Baseline value, categorical fixed effects of treatment, visit and treatment-by-visit interaction, stratification factors at randomization (Baseline CS dose (prednisone or prednisolone \>30 mg, prednisone or prednisolone ≤30 mg) and Baseline disease status (new onset disease, relapsing disease)) included in the model. An unstructured variance covariance matrix is used. Data after initiation of corticosteroid escape therapy are excluded from the model.|LS Mean Difference|5.4216|STANDARD_ERROR_OF_MEAN|3.4785|=|0.1203|TWO_SIDED|95.0|-1.4269|12.2701|||Mixed-Effect Model Repeat Measurement||Difference = 7.5 mg Upadacitinib -Placebo|7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||12.2701|-1.4269|=0.1203
71903632|NCT03725202|143328629|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|1.1|||=|0.4371|TWO_SIDED|95.0|0.8|1.6|||Poisson regression model|||15 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.6|0.8|=0.4371
71903633|NCT03725202|143328629|SUPERIORITY|Comparisons between each upadacitinib treatment group and the placebo group are carried out using Poisson regression model with stratification factors as covariates and log(duration of study participation in years) as an offset. Robust standard error is used in inference.|Rate Ratio|0.9|||=|0.7749|TWO_SIDED|95.0|0.6|1.4|||Poisson regression model|||7.5 mg Upadacitinib + 26-week CS taper vs Placebo + 52-week CS taper||1.4|0.6|=0.7749
71903634|NCT01328249|143328633|OTHER|Fisher's Exact test||||||0.4422||||||Null hypothesis: The feasibility rates of Cohort 1 and Cohort 2 are same.|Fisher Exact|Exploratory analysis comparing primary feasibilities between 2 cohorts, based on Fisher's Exact test.||||||0.4422
71903635|NCT01716533|143328637|SUPERIORITY||GMC ratio|1.53||||0.5746|TWO_SIDED|95.0|0.33|7.14||P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA|ANOVA model -pooled variance.|GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||7.14|0.33|0.5746
71903636|NCT01716533|143328638|SUPERIORITY|ANOVA model -pooled variance.|GMC ratio|1.65||||0.7124|TWO_SIDED|95.0|0.1|26.41||P-value = two-sided p-value for HO: GMC ratio = 1, groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA||GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|Serum F2 C-terminal anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.||26.41|0.10|0.7124
71903637|NCT00495495|143328669|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.1126|ONE_SIDED||||||McNemar|||"Null hypothesis: there is no difference between the HealOzone and Placebo devices in the proportion of teeth with lesion progression after 1 year.~Power calculation: the study was sized to have 90% power to detect a 15% difference between treatments in the percentage of teeth with lesion progression at one year (i.e., assuming 45% for the lesions treated with the Placebo device and 30% for the lesions treated with the HealOzone device) with a sample size of 258 subjects completing the study."||||0.1126
71903638|NCT00495495|143328670|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.08||||0.9777|ONE_SIDED||||||McNemar|||||||.9777
71903639|NCT00495495|143328671|SUPERIORITY_OR_OTHER|||||||0.0416|ONE_SIDED|95.0|||||McNemar|||||||.0416
71903640|NCT00495495|143328672|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.01||||0.6585|ONE_SIDED|95.0|||||McNemar|||||||0.6585
71903641|NCT00495495|143328673|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.02||||0.7666|ONE_SIDED|95.0|||||McNemar|||||||.7666
71903642|NCT01290445|143328696|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.46|1.47||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.47|0.46|
71903643|NCT01290445|143328696|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.45|1.42||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.45|
71903644|NCT01290445|143328697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.09|4.34||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.34|0.09|
71903645|NCT01290445|143328697|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.09|4.67||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||4.67|0.09|
71903646|NCT01290445|143328698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.5|0.96||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.96|0.50|
71903647|NCT01290445|143328698|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.51|0.97||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||0.97|0.51|
71903648|NCT01290445|143328699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.63|1.42||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.42|0.63|
71903649|NCT01290445|143328699|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.61|1.37||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.37|0.61|
71903650|NCT01290445|143328700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
71903651|NCT01290445|143328700|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.37|1.16||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.||1.16|0.37|
71903652|NCT01830543|143328716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||<|0.001|TWO_SIDED|95.0|0.47|0.76|||Log Rank|||||0.76|0.47|<0.001
71903653|NCT01830543|143328716|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.5|0.8|||Log Rank|||||0.8|0.5|<0.001
71903654|NCT01830543|143328717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66||||0.234|TWO_SIDED|95.0|0.33|1.31|||Log Rank|||||1.31|0.33|0.234
71903655|NCT01830543|143328717|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.114|TWO_SIDED|95.0|0.28|1.16|||Log Rank|||||1.16|0.28|0.114
71903656|NCT01830543|143328718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51||||0.144|TWO_SIDED|95.0|0.2|1.28|||Log Rank|||||1.28|0.2|0.144
71903657|NCT01830543|143328718|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5||||0.134|TWO_SIDED|95.0|0.2|1.26|||Log Rank|||||1.26|0.2|0.134
71903658|NCT01830543|143328719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.47|0.8|||Log Rank|||||0.8|0.47|<0.001
71903659|NCT01830543|143328719|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.002|TWO_SIDED|95.0|0.52|0.86|||Log Rank|||||0.86|0.52|0.002
71903660|NCT01830543|143328720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.75|TWO_SIDED|95.0|0.69|1.68|||Log Rank|||||1.68|0.69|0.75
71903661|NCT01830543|143328720|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.765|TWO_SIDED|95.0|0.59|1.48|||Log Rank|||||1.48|0.59|0.765
71903662|NCT01830543|143328721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.523|TWO_SIDED|95.0|0.59|2.8|||Log Rank|||||2.8|0.59|0.523
71903663|NCT01830543|143328721|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.664|TWO_SIDED|95.0|0.54|2.62|||Log Rank|||||2.62|0.54|0.664
71903664|NCT01830543|143328722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.625|TWO_SIDED|95.0|0.46|1.59|||Log Rank|||||1.59|0.46|0.625
71903665|NCT01830543|143328722|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.374|TWO_SIDED|95.0|0.4|1.42|||Log Rank|||||1.42|0.4|0.374
71903666|NCT01830543|143328723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.891|TWO_SIDED|95.0|0.39|2.96|||Log Rank|||||2.96|0.39|0.891
71903667|NCT01830543|143328723|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||0.53|TWO_SIDED|95.0|0.52|3.58|||Log Rank|||||3.58|0.52|0.53
71903668|NCT01830543|143328724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.79|TWO_SIDED|95.0|0.32|4.45|||Log Rank|||||4.45|0.32|0.79
71903669|NCT01830543|143328724|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.574|TWO_SIDED|95.0|0.4|5.09|||Log Rank|||||5.09|0.4|0.574
71821695|NCT01815736|143145841|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|3.2||||0.031|TWO_SIDED|95.0|0.1|6.3||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|All Participants||6.3|0.1|0.031
71903670|NCT02059213|143328727|SUPERIORITY|||||||0.87|||||||Fisher Exact|Mid P-value||With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher's exact test.||||0.87
71903671|NCT02059213|143328729|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||||||0.92
71821696|NCT01815736|143145842|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|5.3||||0.003|TWO_SIDED|95.0|1.6|9.0||P-value for the superiority test comparing the percentages of virologic success was from the CMH test stratified by the prior treatment regimen (STB, ATR, ATV/boosted+TVD).|Cochran-Mantel-Haenszel||Difference in percentages of virologic success and its 95% CI were calculated based on the MH proportion adjusted by the prior treatment regimen.|||9.0|1.6|0.003
71821697|NCT01815736|143145843|SUPERIORITY||Difference in least squares means|6.0||||0.56|TWO_SIDED|95.0|-14.0|26.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means (Diff in LSM), and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. FTC/TDF+3rd Agent) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|NDA Data Cut: Change at Week 48||26|-14|0.56
71821698|NCT01815736|143145843|SUPERIORITY||Difference in least squares means|11.0||||0.26|TWO_SIDED|95.0|-8.0|29.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs.SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|All Participants: Change at Week 48||29|-8|0.26
71821699|NCT01815736|143145844|SUPERIORITY||Difference in least squares means|18.0||||0.074|TWO_SIDED|95.0|-2.0|38.0||P-values were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the analysis of variance (ANOVA) model including treatment (E/C/F/TAF vs. SBR) and prior treatment regimen (STB, ATR, ATV/boosted+TVD) as fixed effects.|||38|-2|0.074
71821700|NCT00550173|143145863|SUPERIORITY_OR_OTHER|||||||0.003||||||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Overall; Global null hypothesis was rejected at 2-sided 0.2 significance level.||||0.003
71821701|NCT00550173|143145863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.002|TWO_SIDED|95.0|0.4|0.81||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.81|0.40|0.002
71903672|NCT02059213|143328730|SUPERIORITY|||||||0.5|||||||Fisher Exact|Mid p-value||||||0.50
71821702|NCT00550173|143145863|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.005|TWO_SIDED|95.0|0.39|0.85||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||0.85|0.39|0.005
71821703|NCT00550173|143145863|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.99||||0.959|TWO_SIDED|95.0|0.7|1.4||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p\<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Secondary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.||1.40|0.70|0.959
71821704|NCT00550173|143145864|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||<0.001
71821705|NCT00550173|143145864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.09||||0.031|TWO_SIDED|95.0|1.07|4.09|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||4.09|1.07|0.031
71903673|NCT02059213|143328731|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
71903674|NCT02059213|143328732|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
71903675|NCT03583372|143328736|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.4|||||TWO_SIDED|95.0|-2.9|-2.0||||||||-2.0|-2.9|
71903676|NCT03583372|143328736|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.0|||||TWO_SIDED|95.0|-2.5|-1.5||||||||-1.5|-2.5|
71680291|NCT02634268|142878513|SUPERIORITY||Mean Difference (Final Values)|-2.31||||0.12|TWO_SIDED|95.0|-5.19|0.56|||Mixed Models Analysis|Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||0.56|-5.19|0.12
71821706|NCT00550173|143145864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.68|||<|0.001|TWO_SIDED|95.0|3.19|18.48|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||18.48|3.19|<0.001
71821707|NCT00550173|143145864|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.27||||0.004|TWO_SIDED|95.0|0.11|0.66|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.66|0.11|0.004
71821708|NCT00550173|143145865|SUPERIORITY_OR_OTHER|||||||0.194|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.194
71821709|NCT00550173|143145865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.747|TWO_SIDED|95.0|0.69|1.67|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.67|0.69|0.747
71821710|NCT00550173|143145865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.168|TWO_SIDED|95.0|0.49|1.13|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.13|0.49|0.168
71821711|NCT00550173|143145865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.094|TWO_SIDED|95.0|0.94|2.21|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.21|0.94|0.094
71821712|NCT00550173|143145867|SUPERIORITY_OR_OTHER|||||||0.306|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.306
71821713|NCT00550173|143145867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.127|TWO_SIDED|95.0|0.87|3.18|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||3.18|0.87|0.127
71853272|NCT05129592|143220220|SUPERIORITY||Mean Difference (Final Values)|1.97|STANDARD_ERROR_OF_MEAN|4.66||0.965|TWO_SIDED|95.0|-9.25|13.19|||ANCOVA|Sidak's adjusted p-value (df=4)|Nicotine corrective control - Nicotine corrective with both components of coherence|ANCOVA adjusted for baseline consideration of switching||13.19|-9.25|0.965
71821714|NCT00550173|143145867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.318|TWO_SIDED|95.0|0.72|2.71|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.71|0.72|0.318
71821715|NCT00550173|143145867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.599|TWO_SIDED|95.0|0.63|2.22|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||2.22|0.63|0.599
71821716|NCT00550173|143145868|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||||0.013
71821717|NCT00550173|143145868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.007|TWO_SIDED|95.0|0.41|0.87||Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.87|0.41|0.007
71821718|NCT00550173|143145868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.62|1.38|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||1.38|0.62|0.700
71821719|NCT00550173|143145868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.023|TWO_SIDED|95.0|0.44|0.94|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||||0.94|0.44|0.023
71821720|NCT00550173|143145869|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Regression, Cox|||||||0.040
71821721|NCT00550173|143145869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62||||0.241|TWO_SIDED|95.0|0.27|1.38|||Regression, Cox|||||1.38|0.27|0.241
71821722|NCT00550173|143145869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.32||||0.011|TWO_SIDED|95.0|0.14|0.78|||Regression, Cox|||||0.78|0.14|0.011
71821723|NCT00550173|143145869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.9||||0.128|TWO_SIDED|95.0|0.83|4.36|||Regression, Cox|||||4.36|0.83|0.128
71821724|NCT01875861|143145871|SUPERIORITY||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|1.02|1.38||||||Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.||1.38|1.02|
71821725|NCT01875861|143145872|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.03|1.39||||||See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.||1.39|1.03|
71821726|NCT02325713|143145880|SUPERIORITY_OR_OTHER||Geometric Least square (LS) mean ratio|96.2|||||TWO_SIDED|90.0|83.7|110.6||||||||110.6|83.7|
71821727|NCT02325713|143145880|SUPERIORITY_OR_OTHER||Geometric LS mean ration|18.4|||||TWO_SIDED|90.0|15.3|22.0||||||||22.0|15.3|
71821728|NCT02325713|143145880|SUPERIORITY_OR_OTHER||Geometric LS mean ration|222.7|||||TWO_SIDED|90.0|186.8|265.6||||||||265.6|186.8|
71821729|NCT02325713|143145880|SUPERIORITY_OR_OTHER||Geometric LS mean ration|238.1|||||TWO_SIDED|90.0|198.7|285.3||||||||285.3|198.7|
71821730|NCT02325713|143145880|SUPERIORITY_OR_OTHER||Geometric LS mean ration|82.1|||||TWO_SIDED|90.0|68.5|98.3||||||||98.3|68.5|
71903677|NCT03583372|143328737|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.2|||||TWO_SIDED|95.0|-2.5|-1.9||||||||-1.9|-2.5|
71821731|NCT03824535|143145911|SUPERIORITY|||||||0.02||||||The threshold for statistical significance was set at p \< 0.05|Wilcoxon (Mann-Whitney)|||Analysis applies to the row 'Specificity' in the Outcome Measure data table.||||0.02
71821732|NCT03824535|143145912|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was predefined as p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.004
71821733|NCT03824535|143145912|SUPERIORITY|||||||0.05||||||The threshold for statistical significance was predefined as p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||||||0.05
71821734|NCT03824535|143145912|SUPERIORITY|||||||0.06||||||The threshold for statistical significance was predefined as p \< 0.05.|Wilcoxon (Mann-Whitney)|||||||0.06
71821735|NCT03531905|143145931|SUPERIORITY||Difference of Least Squares (LS) means|-39.6|STANDARD_ERROR_OF_MEAN|3.14|<|0.001|TWO_SIDED|95.0|-45.8|-33.4|||ANCOVA|||||-33.4|-45.8|<0.001
71821736|NCT03531905|143145931|SUPERIORITY||Difference of LS means|-19.5|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-25.7|-13.4|||ANCOVA|||||-13.4|-25.7|<0.001
71821737|NCT03531905|143145931|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
71821738|NCT03531905|143145932|SUPERIORITY||Difference of LS means|-20.1|STANDARD_ERROR_OF_MEAN|3.08|<|0.001|TWO_SIDED|95.0|-26.2|-14.0|||ANCOVA|||||-14.0|-26.2|<0.001
71821739|NCT03531905|143145933|SUPERIORITY||Location shift|-36.7|STANDARD_ERROR_OF_MEAN|9.77|<|0.001|TWO_SIDED|95.0|-55.97|-17.67|||Wilcoxon rank sum test|||||-17.67|-55.97|<0.001
71821740|NCT03531905|143145933|SUPERIORITY||Location shift|-29.2|STANDARD_ERROR_OF_MEAN|10.03||0.005|TWO_SIDED|95.0|-48.92|-9.62|||Wilcoxon rank sum test|||||-9.62|-48.92|0.005
71821741|NCT03531905|143145933|SUPERIORITY||Location shift|-7.5|STANDARD_ERROR_OF_MEAN|11.29||0.48|TWO_SIDED|95.0|-30.51|13.76|||Wilcoxon rank sum test|||||13.76|-30.51|0.480
71821742|NCT03531905|143145934|SUPERIORITY||Difference of LS means|-33.1|STANDARD_ERROR_OF_MEAN|2.81|<|0.001|TWO_SIDED|95.0|-38.6|-27.5|||ANCOVA|||||-27.5|-38.6|<0.001
71821743|NCT03531905|143145934|SUPERIORITY||Difference of LS means|-15.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-20.8|-9.7|||ANCOVA|||||-9.7|-20.8|<0.001
71821744|NCT03531905|143145934|SUPERIORITY||Difference of LS means|-17.8|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-23.3|-12.4|||ANCOVA|||||-12.4|-23.3|<0.001
71821745|NCT03531905|143145935|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-31.7|-22.8|||ANCOVA|||||-22.8|-31.7|<0.001
71821746|NCT03531905|143145935|SUPERIORITY||Difference of LS means|-13.4|STANDARD_ERROR_OF_MEAN|2.24|<|0.001|TWO_SIDED|95.0|-17.8|-9.0|||ANCOVA|||||-9.0|-17.8|<0.001
71821747|NCT03531905|143145935|SUPERIORITY||Difference of LS means|-13.9|STANDARD_ERROR_OF_MEAN|2.21|<|0.001|TWO_SIDED|95.0|-18.2|-9.5|||ANCOVA|||||-9.5|-18.2|<0.001
71821748|NCT03531905|143145936|SUPERIORITY||Difference of LS means|-27.2|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-32.6|-21.8|||ANCOVA|||||-21.8|-32.6|<0.001
71821749|NCT03531905|143145936|SUPERIORITY||Difference of LS means|-12.8|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-18.1|-7.4|||ANCOVA|||||-7.4|-18.1|<0.001
71821750|NCT03531905|143145936|SUPERIORITY||Difference of LS means|-14.4|STANDARD_ERROR_OF_MEAN|2.68|<|0.001|TWO_SIDED|95.0|-19.7|-9.1|||ANCOVA|||||-9.1|-19.7|<0.001
71821751|NCT03531905|143145937|SUPERIORITY||Location shift|-3.9|STANDARD_ERROR_OF_MEAN|5.44||0.457|TWO_SIDED|95.0|-14.55|6.79|||Wilcoxon rank sum test|||||6.79|-14.55|0.457
71821752|NCT03531905|143145937|SUPERIORITY||Difference of LS means|4.7|STANDARD_ERROR_OF_MEAN|5.25||0.351|TWO_SIDED|95.0|-4.93|15.63|||ANCOVA|||||15.63|-4.93|0.351
71821753|NCT03531905|143145937|SUPERIORITY||Difference of LS means|-9.2|STANDARD_ERROR_OF_MEAN|4.75||0.068|TWO_SIDED|95.0|-17.92|0.68|||ANCOVA|||||0.68|-17.92|0.068
71821754|NCT03531905|143145938|SUPERIORITY||Difference of LS means|-5.9|STANDARD_ERROR_OF_MEAN|2.14||0.007|TWO_SIDED|95.0|-10.1|-1.7|||ANCOVA|||||-1.7|-10.1|0.007
71821755|NCT03531905|143145938|SUPERIORITY||Difference of LS means|-7.3|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-11.5|-3.1|||ANCOVA|||||-3.1|-11.5|<0.001
71821756|NCT03531905|143145938|SUPERIORITY||Difference of LS means|1.4|STANDARD_ERROR_OF_MEAN|2.11||0.517|TWO_SIDED|95.0|-2.8|5.5|||ANCOVA|||||5.5|-2.8|0.517
71821757|NCT03531905|143145939|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71821758|NCT03531905|143145939|SUPERIORITY|||||||0.118|||||||Fisher Exact|||||||0.118
71821759|NCT03531905|143145939|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71821760|NCT03531905|143145940|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71821761|NCT03531905|143145940|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71821762|NCT03531905|143145942|SUPERIORITY||Difference of LS means|-0.3|STANDARD_ERROR_OF_MEAN|1.83||0.877|TWO_SIDED|95.0|-3.9|3.3|||ANCOVA|||||3.3|-3.9|0.877
71821763|NCT03531905|143145942|SUPERIORITY||Difference of LS means|0.8|STANDARD_ERROR_OF_MEAN|1.83||0.669|TWO_SIDED|95.0|-2.8|4.4|||ANCOVA|||||4.4|-2.8|0.669
71821764|NCT03531905|143145942|SUPERIORITY||Difference of LS means|-1.1|STANDARD_ERROR_OF_MEAN|1.81||0.556|TWO_SIDED|95.0|-4.6|2.5|||ANCOVA|||||2.5|-4.6|0.556
71821765|NCT03531905|143145943|SUPERIORITY||Difference of LS means|2.5|STANDARD_ERROR_OF_MEAN|4.64||0.589|TWO_SIDED|95.0|-6.7|11.7|||ANCOVA|||||11.7|-6.7|0.589
71821766|NCT03531905|143145943|SUPERIORITY||Difference of LS means|0.6|STANDARD_ERROR_OF_MEAN|4.64||0.904|TWO_SIDED|95.0|-8.6|9.7|||ANCOVA|||||9.7|-8.6|0.904
71821767|NCT03531905|143145943|SUPERIORITY||Difference of LS means|2.0|STANDARD_ERROR_OF_MEAN|4.66||0.676|TWO_SIDED|95.0|-7.3|11.2|||ANCOVA|||||11.2|-7.3|0.676
71821768|NCT03531905|143145945|SUPERIORITY||Difference of LS means|-15.8|STANDARD_ERROR_OF_MEAN|13.95||0.258|TWO_SIDED|95.0|-43.4|11.7|||ANCOVA|||||11.7|-43.4|0.258
71903678|NCT03583372|143328737|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.7|||||TWO_SIDED|95.0|-2.0|-1.3||||||||-1.3|-2.0|
71821769|NCT03531905|143145945|SUPERIORITY||Difference of LS means|0.5|STANDARD_ERROR_OF_MEAN|13.79||0.972|TWO_SIDED|95.0|-26.8|27.7|||ANCOVA|||||27.7|-26.8|0.972
71821770|NCT03531905|143145945|SUPERIORITY||Difference of LS means|-16.3|STANDARD_ERROR_OF_MEAN|13.68||0.235|TWO_SIDED|95.0|-43.3|10.7|||ANCOVA|||||10.7|-43.3|0.235
71821771|NCT03639675|143145957|OTHER||Mean change|-8.3||||0.0004|TWO_SIDED|95.0|-12.2|-4.4|||one-sample t-statistics|||||-4.4|-12.2|0.0004
71821772|NCT02264574|143145959|SUPERIORITY||Hazard Ratio (HR)|0.231|||<|0.0001|TWO_SIDED|95.0|0.145|0.367|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.367|0.145|<0.0001
71821773|NCT02264574|143145960|SUPERIORITY||Hazard Ratio (HR)|0.119|||<|0.0001|TWO_SIDED|95.0|0.046|0.307|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||0.307|0.046|< 0.0001
71821774|NCT02264574|143145961|SUPERIORITY|||||||0.5253|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5253
71821775|NCT02264574|143145962|SUPERIORITY|||||||0.5465|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.5465
71821776|NCT02264574|143145963|SUPERIORITY||Rate Ratio|1.208||||0.0035|TWO_SIDED|95.0|1.062|1.373|||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.373|1.062|0.0035
71821777|NCT02264574|143145964|SUPERIORITY||Hazard Ratio (HR)|0.921||||0.8057|TWO_SIDED|95.0|0.479|1.772|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||1.772|0.479|0.8057
71821778|NCT02264574|143145965|SUPERIORITY|||||||0.0835|||||||Fisher Exact|||"IRR Preferred Term~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.0835
71821779|NCT02264574|143145965|SUPERIORITY|||||||0.1944|||||||Fisher Exact|||"IRR By Customized SMQ~To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record."||||0.1944
71821780|NCT02264574|143145966|SUPERIORITY|||||||0.0045|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.0045
71821781|NCT02264574|143145967|SUPERIORITY|||||||0.859|||||||Chi-squared|||To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.||||0.8590
71821782|NCT02264574|143145968|SUPERIORITY||Hazard Ratio (HR)|0.169|||<|0.0001|TWO_SIDED|95.0|0.102|0.282|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.282|0.102|< 0.0001
71821783|NCT02264574|143145969|SUPERIORITY|||||||0.9657|||||||Chi-squared|||||||0.9657
71821784|NCT02264574|143145970|SUPERIORITY|||||||0.1612|||||||Chi-squared|||||||0.1612
71821785|NCT02264574|143145971|SUPERIORITY||Rate Ratio|1.125||||0.0273|TWO_SIDED|95.0|1.013|1.25|||Chi-squared|||||1.250|1.013|0.0273
71821786|NCT02264574|143145972|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.7934|TWO_SIDED|95.0|0.595|1.973|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||1.973|0.595|0.7934
71821787|NCT02264574|143145973|SUPERIORITY|||||||0.005|||||||Chi-squared|||||||0.0050
71821788|NCT02264574|143145974|SUPERIORITY||Hazard Ratio (HR)|0.251|||<|0.0001|TWO_SIDED|95.0|0.162|0.389|||Log Rank|The treatment effect was tested with an unstratified log rank test.|The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.|||0.389|0.162|< 0.0001
71821789|NCT02886728|143145980|SUPERIORITY||Difference in Response Rates|9.6|||<|0.001|TWO_SIDED|95.0|3.6|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||15.6|3.6|<0.001
71903679|NCT03583372|143328738|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.4|||||TWO_SIDED|95.0|-4.0|-2.7||||||||-2.7|-4.0|
71903680|NCT03583372|143328738|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-3.2|||||TWO_SIDED|95.0|-4.0|-2.5||||||||-2.5|-4.0|
71680292|NCT02634268|142878514|SUPERIORITY||Mean Difference (Final Values)|-2.72||||0.03|TWO_SIDED|95.0|-5.19|-0.25|||Mixed Models Analysis|Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.25|-5.19|0.03
71853273|NCT05129592|143220220|SUPERIORITY||Mean Difference (Final Values)|1.57|STANDARD_ERROR_OF_MEAN|4.44||0.979|TWO_SIDED|95.0|-9.13|12.27|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with causal explanation - Nicotine corrective with both components of coherence|12.27|-9.13|0.979
71853274|NCT05129592|143220220|SUPERIORITY||Mean Difference (Final Values)|4.07|STANDARD_ERROR_OF_MEAN|4.37||0.73|TWO_SIDED|95.0|-6.46|14.59|||ANCOVA|Sidak's adjusted p-value (df=4)||ANCOVA adjusted for baseline consideration of switching|Nicotine corrective with reason for misperception - Nicotine corrective with both components of coherence|14.59|-6.46|0.73
71853275|NCT00609245|143220234|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANOVA|||||||0.016
71853276|NCT01234675|143220235|SUPERIORITY||Paired difference|4.6||||0.424|TWO_SIDED|95.0|-7.3|16.6|||Paired T test|||||16.6|-7.3|0.424
71853277|NCT01234675|143220236|SUPERIORITY||Paired difference|-6.1||||0.049|TWO_SIDED|95.0|-12.2|-0.04|||Paired T test|||||-0.04|-12.2|0.049
71853278|NCT01234675|143220237|SUPERIORITY||Paired difference|22.6||||0.056|TWO_SIDED|95.0|-0.6|45.8|||Paired T test|||||45.8|-0.6|0.056
71853279|NCT01234675|143220238|SUPERIORITY||Paired difference|-6.1||||0.683|TWO_SIDED|95.0|-12.5|18.5|||Paired T test|||||18.5|-12.5|0.683
71853280|NCT01234675|143220239|SUPERIORITY||Paired difference|-1.502||||0.155|TWO_SIDED|95.0|-59.1|10.4|||Paired T test|||||10.4|-59.1|0.155
71853281|NCT01234675|143220240|SUPERIORITY||Paired difference|-1.0||||0.805|TWO_SIDED|95.0|-9.8|7.8|||Paired T test|||||7.8|-9.8|0.805
71853282|NCT01234675|143220241|SUPERIORITY||Paired difference|-1.0||||0.844|TWO_SIDED|95.0|-11.6|9.6|||Paired T test|||||9.6|-11.6|0.844
71680293|NCT02634268|142878515|SUPERIORITY||Mean Difference (Final Values)|-2.42||||0.03|TWO_SIDED|95.0|-4.55|-0.28|||Mixed Models Analysis|Difference in average SGRQ-C Total score at 12 months between control and intervention groups.|Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.|Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.||-0.28|-4.55|0.03
71853283|NCT01234675|143220242|SUPERIORITY||Paired difference|2.9||||0.509|TWO_SIDED|95.0|-6.4|12.2|||Paired T test|||||12.2|-6.4|0.509
71853284|NCT01234675|143220243|SUPERIORITY||Paired difference|0.32||||0.3|TWO_SIDED|95.0|-0.3|0.6|||Paired T test|||||0.6|-0.3|0.3
71853285|NCT01234675|143220244|SUPERIORITY||Paired difference|-1.03||||0.685|TWO_SIDED|95.0|-8.2|5.6|||Paired T test|||||5.6|-8.2|0.685
71853286|NCT01234675|143220245|SUPERIORITY||Paired difference|-5.3||||0.349|TWO_SIDED|95.0|-17.0|6.4|||Paired T test|||||6.4|-17.0|0.349
71853287|NCT01234675|143220246|SUPERIORITY||Paired difference|-0.6||||0.305|TWO_SIDED|95.0|-1.8|5.6|||Paired T test|||||5.6|-1.8|0.305
71853288|NCT01234675|143220247|SUPERIORITY||Paired difference|-0.5||||0.425|TWO_SIDED|95.0|-1.8|0.8|||Paired T test|||||0.8|-1.8|0.425
71853289|NCT00331799|143220248|SUPERIORITY_OR_OTHER|||||||0.00365|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.||||0.00365
71853290|NCT02889809|143220249|OTHER||Least Square (LS) Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.462|0.142|||||Analysis was performed using an analysis of covariance (ANCOVA) model adjusting for Baseline growth velocity, age at Visit 1, gender and country.|||0.142|-0.462|
71853291|NCT02889809|143220252|OTHER||LS Mean Difference|0.059|||||TWO_SIDED|95.0|-0.455|0.572|||||Analysis was performed using an ANCOVA model adjusting for Baseline growth velocity, age at Visit 1(wk -16), gender and country|||0.572|-0.455|
71853292|NCT05065918|143220256|SUPERIORITY||Slope|-0.536||||0.448|TWO_SIDED|95.0|-1.929|0.857|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.857|-1.929|0.448
71853293|NCT05065918|143220257|SUPERIORITY||Slope|0.99||||0.969|TWO_SIDED|95.0|-1.152|1.108|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.108|-1.152|0.969
71853294|NCT05065918|143220258|SUPERIORITY||Slope|-0.5||||0.231|TWO_SIDED|95.0|-1.322|0.322|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.322|-1.322|0.231
71903681|NCT03583372|143328739|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-2.5|||||TWO_SIDED|95.0|-2.8|-2.2||||||||-2.2|-2.8|
71903682|NCT03583372|143328739|OTHER|Estimation of within treatment group change from Baseline|Least squares mean|-1.9|||||TWO_SIDED|95.0|-2.3|-1.6||||||||-1.6|-2.3|
71903683|NCT01151046|143328741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.003|TWO_SIDED|95.0|0.11|0.63|||Log Rank|||||0.63|0.11|0.003
71903684|NCT01151046|143328741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.41||||0.349|TWO_SIDED|95.0|0.69|2.88|||Log Rank|||||2.88|0.69|0.349
71903685|NCT05439460|143328747|OTHER|||||||0.9|||||||t-test, 2 sided|||Change in phenylephrine group||||0.9
71903686|NCT05439460|143328747|OTHER|||||||0.3||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in arginine vasopressin group||||0.3
71903687|NCT05439460|143328747|OTHER|||||||1||||||A p-value of \<0.05 would be considered statistically significant.|t-test, 2 sided|||Change in epinephrine group||||1
71903688|NCT03446651|143328748|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||||||0.56
71903689|NCT03446651|143328750|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
71903690|NCT03446651|143328752|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71903691|NCT03446651|143328753|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71903692|NCT02420223|143328754|SUPERIORITY|||||||0.017|||||||Regression, Logistic|||||||.017
71903693|NCT02420223|143328754|SUPERIORITY|||||||0.337|||||||Regression, Logistic|||||||0.337
71903694|NCT02420223|143328757|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.14
71903695|NCT02420223|143328758|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71903696|NCT02420223|143328759|SUPERIORITY|||||||0.06|||||||Likelihood ration Chi-Square test|||||||0.06
71903697|NCT04131517|143328767|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the least squares (LS) means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0404|||||TWO_SIDED|90.0|0.94156|1.1497||||||The analysis of variance model (ANOVA) included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1497|0.94156|
71903698|NCT04131517|143328768|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.89272|||||TWO_SIDED|90.0|0.76892|1.0364||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0364|0.76892|
71903699|NCT04131517|143328771|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|1.0276|||||TWO_SIDED|90.0|0.95544|1.1052||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.1052|0.95544|
71903700|NCT04131517|143328772|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL+ OC and OC Alone of the LS means for the log-transformed AUC0-inf was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.88808|||||TWO_SIDED|90.0|0.52185|1.5113||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.5113|0.52185|
71903701|NCT04131517|143328779|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed Cmax was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96378|||||TWO_SIDED|90.0|0.85043|1.0922||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0922|0.85043|
71903702|NCT04131517|143328781|OTHER|A lack of PSL effect on EE and LN would have been concluded if the 90% CI of the geometric mean ratio between treatment with PSL + OC and OC Alone of the LS means for the log-transformed AUC was within the bioequivalence acceptance range of 80% to 125%.|Geometric LS Mean ratio|0.96842|||||TWO_SIDED|90.0|0.91888|1.0206||||||The ANOVA model included Treatment, Period, and Sequence as fixed effects and participant within Sequence as a random effect.||1.0206|0.91888|
71903703|NCT04149899|143328783|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-4.9|STANDARD_DEVIATION|1.85|<|0.001|TWO_SIDED|95.0|-5.73|-4.14||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.14|-5.73|<0.001
71903704|NCT04149899|143328783|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-5.1|STANDARD_DEVIATION|2.51|<|0.001|TWO_SIDED|95.0|-6.14|-4.02||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.02|-6.14|<0.001
71903705|NCT04149899|143328783|OTHER|The null hypothesis is that the mean change from Baseline, Hour 2 = 0 at Day 14, Hour 2.|Mean Difference (Net)|-6.0|STANDARD_DEVIATION|3.05|<|0.001|TWO_SIDED|95.0|-7.93|-4.07||The p-value was not adjusted for multiple comparisons.|t-test, 2 sided|||A within-group comparison was performed between Baseline, Hour 2 and Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5%.||-4.07|-7.93|<0.001
71903706|NCT04149899|143328783|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.15% and Timolol 0.5%.||1.43|-1.16|0.828
71903707|NCT04149899|143328783|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Net)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model used the Baseline IOP values at Hour 2 as the covariate.|The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP change from Baseline, Hour 2 to Day 14, Hour 2 (the timepoint for the peak effect of Timolol 0.5%) was compared between WB007 0.4% and Timolol 0.5%.||0.89|-1.73|0.520
71853295|NCT05065918|143220259|SUPERIORITY||Slope|-0.319||||0.398|TWO_SIDED|95.0|-1.064|0.425|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.425|-1.064|0.398
71853296|NCT05065918|143220260|SUPERIORITY||Slope|0.284||||0.382|TWO_SIDED|95.0|-0.356|0.924|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||.924|-.356|0.382
71853297|NCT05065918|143220261|SUPERIORITY||Slope|0.382||||0.266|TWO_SIDED|95.0|-0.284|1.025|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.025|-.284|0.266
71853298|NCT05065918|143220262|SUPERIORITY||Slope|0.53||||0.019|TWO_SIDED|95.0|0.089|0.97|||Regression, Linear|||||.970|0.089|0.019
71853299|NCT05065918|143220263|SUPERIORITY||Slope|0.277||||0.284|TWO_SIDED|95.0|-0.232|0.787|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||0.787|-.232|0.284
71853300|NCT05065918|143220264|SUPERIORITY||Slope|0.709||||0.076|TWO_SIDED|95.0|-0.076|1.494|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.494|-.076|0.076
71903708|NCT04149899|143328784|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|0.14||||0.828|TWO_SIDED|95.0|-1.16|1.43||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||1.43|-1.16|0.828
71903709|NCT04149899|143328784|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANCOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.42||||0.52|TWO_SIDED|95.0|-1.73|0.89||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANCOVA||The estimated treatment difference is based on the least-square means from the ANCOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.89|-1.73|0.520
71903710|NCT04149899|143328784|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-0.84||||0.283|TWO_SIDED|95.0|-2.39|0.71||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.15% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.71|-2.39|0.283
71853301|NCT05065918|143220265|SUPERIORITY||Slope|0.625||||0.136|TWO_SIDED|95.0|-0.199|1.449|||Regression, Linear|||Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.||1.449|-.199|0.136
71853302|NCT01090076|143220266|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||t-test, 2 sided|||||||0.023
71853303|NCT01090076|143220267|SUPERIORITY_OR_OTHER|||||||0.877||95.0|||||t-test, 2 sided|||||||0.877
71853304|NCT01090076|143220268|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
71853305|NCT00113880|143220275|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.||||0.01
71853306|NCT00113880|143220275|SUPERIORITY_OR_OTHER|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.01
71853307|NCT00113880|143220275|SUPERIORITY_OR_OTHER|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
71853308|NCT00113880|143220275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.59||||0.02|TWO_SIDED|95.0|0.64|3.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||3.92|0.64|0.02
71680294|NCT00805870|142878516|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.271|STANDARD_ERROR_OF_MEAN|26.298|>|0.05|TWO_SIDED|95.0|-63.521|46.978|||ANOVA|||Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.||46.978|-63.521|>0.05
71853309|NCT00113880|143220275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.35||||0.01|TWO_SIDED|95.0|2.2|24.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.54|2.20|0.01
71853310|NCT00113880|143220275|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.17||||0.01|TWO_SIDED|95.0|2.13|24.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.||24.13|2.13|0.01
71853311|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.03|TWO_SIDED|95.0|0.0|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.79|0.00|0.03
71853312|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.13||||0.05|TWO_SIDED|95.0|0.02|1.0||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||1.00|0.02|0.05
71853313|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11||||0.04|TWO_SIDED|95.0|0.01|0.86||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.||0.86|0.01|0.04
71853314|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.2|0.7||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.70|0.20|0.01
71853315|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4||||0.01|TWO_SIDED|95.0|0.22|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the all ages combined group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.74|0.22|0.01
71680295|NCT00805870|142878517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.845|STANDARD_ERROR_OF_MEAN|1.417|>|0.05|TWO_SIDED|95.0|-4.823|1.132|||ANOVA|||Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.||1.132|-4.823|>0.05
71853316|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05||||0.01|TWO_SIDED|95.0|0.03|0.08||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age and the all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.08|0.03|0.01
71853317|NCT00113880|143220276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.02||||0.01|TWO_SIDED|95.0|0.01|0.03|||Regression, Cox||Population was the 18-49 year age and all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.||0.03|0.01|0.01
71853318|NCT00113880|143220277|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.06||||0.04|TWO_SIDED|95.0|1.02|4.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Urticaria event rates were presented per 1,000 person-months.||4.13|1.02|0.04
71853319|NCT00113880|143220279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.01|TWO_SIDED|95.0|0.56|0.89||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.89|0.56|0.01
71903711|NCT04149899|143328784|NON_INFERIORITY|A pairwise treatment group comparison was performed versus timolol ophthalmic solution 0.5%. A 2-sided 95% confidence interval (CI) for the treatment difference (WB007 minus Timolol) was constructed based on an ANOVA model. If WB007 was determined to be non-inferior to Timolol, an attempt to show superiority of WB007 over Timolol was made.|Mean Difference (Final Values)|-1.02||||0.189|TWO_SIDED|95.0|-2.56|0.52||The p-value (2-sided) for superiority was not adjusted for multiple comparisons.|ANOVA|The ANOVA model has the treatment group as the main effect.|The estimated treatment difference is based on the least-square means from the ANOVA model.|The mean IOP for WB007 0.4% was compared to Timolol 0.5% at Day 14, Hour 2, the timepoint for the peak effect of Timolol 0.5% and the primary efficacy timepoint for the study.||0.52|-2.56|0.189
71903712|NCT03664193|143328802|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 37.5 Gy.|Proportion (percent)|30.0|||||TWO_SIDED|95.0|14.7|49.3||||||||49.3|14.7|
71903713|NCT03664193|143328802|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 40.0 Gy.|Proportion (percent)|46.7|||||TWO_SIDED|95.0|28.3|65.7||||||||65.7|28.3|
71903714|NCT03664193|143328802|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 42.5 Gy.|Proportion (percent)|6.7|||||TWO_SIDED|95.0|0.8|22.1||||||||22.1|0.8|
71903715|NCT03664193|143328802|OTHER|Simple descriptive feasibility proportion and exact 95% confidence interval for radiation dose of 45.0 Gy.|Proportion (percent)|16.7|||||TWO_SIDED|95.0|5.6|34.7||||||||34.7|5.6|
71903716|NCT03664193|143328803|OTHER|Simple proportion and exact 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|88.4|100.0||||||||100.0|88.4|
71821790|NCT02886728|143145980|SUPERIORITY||Difference in Response Rates|8.8||||0.017|TWO_SIDED|95.0|1.5|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||16.1|1.5|0.017
71821791|NCT02886728|143145980|SUPERIORITY||Difference in Response Rates|6.7||||0.058|TWO_SIDED|95.0|-0.7|14.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||14.1|-0.7|0.058
71821792|NCT02886728|143145981|SUPERIORITY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.041|<|0.001|TWO_SIDED|95.0|-0.27|-0.11||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.27|<0.001
71821793|NCT02886728|143145981|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.049||0.009|TWO_SIDED|95.0|-0.23|-0.03||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.03|-0.23|0.009
71821794|NCT02886728|143145981|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.032|TWO_SIDED|95.0|-0.2|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.20|0.032
71821795|NCT02886728|143145982|SUPERIORITY||Difference in Response Rates|25.0|||<|0.001|TWO_SIDED|95.0|18.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||31.7|18.3|<0.001
71903717|NCT01773135|143328806|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||U statistic|||||||<0.001
71903718|NCT02345252|143328808|NON_INFERIORITY|A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-0.3|||||TWO_SIDED|95.001|-4.2|3.7|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the FTC/RPV/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA \< 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the FTC/RPV/TDF group.||3.7|-4.2|
71903719|NCT02345252|143328808|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71680296|NCT00805870|142878518|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.015|STANDARD_ERROR_OF_MEAN|47.093|>|0.05|TWO_SIDED|95.0|-156.373|42.344|||ANOVA|||Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.||42.344|-156.373|>0.05
71821796|NCT02886728|143145982|SUPERIORITY||Difference in Response Rates|13.4|||<|0.001|TWO_SIDED|95.0|5.0|21.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||21.8|5.0|<0.001
71821797|NCT02886728|143145982|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|5.0|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.6|5.0|<0.001
71821798|NCT02886728|143145983|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.161||0.068|TWO_SIDED|95.0|-0.61|0.02||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.02|-0.61|0.068
71821799|NCT02886728|143145983|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.195||0.14|TWO_SIDED|95.0|-0.67|0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.10|-0.67|0.14
71821800|NCT02886728|143145983|SUPERIORITY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.199||0.006|TWO_SIDED|95.0|-0.94|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-0.94|0.006
71821801|NCT02886728|143145984|SUPERIORITY||Least Squares Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|1.8|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.8|<0.001
71821802|NCT02886728|143145984|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.69||0.021|TWO_SIDED|95.0|0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.2|0.021
71853320|NCT00113880|143220279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.59||||0.01|TWO_SIDED|95.0|0.41|0.83||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.83|0.41|0.01
71853321|NCT00113880|143220279|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.04|TWO_SIDED|95.0|0.46|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.46|0.04
71853322|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.33||||0.01|TWO_SIDED|95.0|0.27|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.41|0.27|0.01
71853323|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.01|TWO_SIDED|95.0|0.22|0.42||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.42|0.22|0.01
71680297|NCT00805870|142878519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.022|STANDARD_ERROR_OF_MEAN|0.188|>|0.05|TWO_SIDED|95.0|-0.374|0.417|||ANOVA|||The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.||0.417|-0.374|>0.05
71688691|NCT02634983|142892846|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|90.0|0.33|0.55|||t-test, 2 sided|||FVC Day 8 (2 hrs post-dose)||0.55|0.33|<0.0001
71821803|NCT02886728|143145984|SUPERIORITY||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.69||0.24|TWO_SIDED|95.0|-0.5|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.5|0.24
71903720|NCT00779324|143328826|OTHER||Difference in percents|-0.4||||0.9554|TWO_SIDED|95.0|-14.7|13.9|||Chi-squared|||||13.9|-14.7|0.9554
71853324|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.34||||0.01|TWO_SIDED|95.0|0.24|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.47|0.24|0.01
71853325|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.23|0.75||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.75|0.23|0.01
71853326|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.01|TWO_SIDED|95.0|0.33|0.44||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.44|0.33|0.01
71903721|NCT00779324|143328827|OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71903722|NCT00779324|143328828|OTHER||Difference in percents|10.8||||0.1662|TWO_SIDED|95.0|-4.2|25.8|||Chi-squared|||||25.8|-4.2|0.1662
71903723|NCT00779324|143328829|OTHER|||||||0.3488|||||||Wilcoxon (Mann-Whitney)|||||||0.3488
71903724|NCT00779324|143328831|OTHER||Difference in percents|6.4||||0.38|TWO_SIDED|95.0|-7.2|20.0|||Chi-squared|||||20|-7.2|0.38
71903725|NCT00779324|143328832|OTHER||Difference in percents|11.7||||0.1373|TWO_SIDED|95.0|-3.3|26.7|||Chi-squared|||||26.7|-3.3|0.1373
71903726|NCT00779324|143328833|OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71903727|NCT00779324|143328834|OTHER|||||||0.0353|||||||Wilcoxon (Mann-Whitney)|||||||0.0353
71903728|NCT02913222|143328838|OTHER|||||||1||||||The threshold for statistical significance was set at p = 0.05.|Fisher Exact|||A priori criteria for success was that we would achieve 90% adherence to attending treatment sessions. Fisher's exact test compared patient adherence to treatment session rates by site and by group.||||1.0
71903729|NCT02913222|143328839|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-2.2||||0.32|TWO_SIDED|95.0|-6.51|2.11||The threshold for statistical significance was p = 0.05|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||2.11|-6.51|0.32
71853327|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.01|TWO_SIDED|95.0|0.32|0.5||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.50|0.32|0.01
71853328|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.36||||0.01|TWO_SIDED|95.0|0.28|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.45|0.28|0.01
71903730|NCT02913222|143328840|OTHER|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-5.55||||0.14|TWO_SIDED|95.0|-13.1|1.99||The threshold for statistical significance was p = 0.05.|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.||1.99|-13.10|0.14
71903731|NCT01100307|143328880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.85||||0.0003|TWO_SIDED|95.0|1.92|12.28||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|Cochran-Mantel-Haenszel|Stratification factors (HbA1c and baseline visual acuity categories)||The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||12.28|1.92|0.0003
71903732|NCT01100307|143328881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.0006|TWO_SIDED|95.0|1.1|3.94||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||3.94|1.10|0.0006
71903733|NCT01100307|143328881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.0001|TWO_SIDED|95.0|1.81|5.58||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||5.58|1.81|0.0001
71821804|NCT02886728|143145985|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.68||0.056|TWO_SIDED|95.0|0.0|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.0|0.056
71821805|NCT02886728|143145985|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.82||0.1|TWO_SIDED|95.0|-0.3|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-0.3|0.10
71853329|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41||||0.01|TWO_SIDED|95.0|0.27|0.6||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.60|0.27|0.01
71853330|NCT00113880|143220280|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.05|TWO_SIDED|95.0|0.21|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years, PD2 within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.99|0.21|0.05
71853331|NCT00113880|143220281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.01|TWO_SIDED|95.0|0.86|0.98||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.98|0.86|0.01
71853332|NCT00113880|143220281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.01|TWO_SIDED|95.0|0.75|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs., within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.92|0.75|0.01
71853333|NCT00113880|143220281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.87||||0.01|TWO_SIDED|95.0|0.81|0.94||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: All ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.94|0.81|0.01
71853334|NCT00113880|143220281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.01|TWO_SIDED|95.0|0.7|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.88|0.70|0.01
71853335|NCT00113880|143220281|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.29|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.79|0.29|0.01
71853336|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.48||||0.01|TWO_SIDED|95.0|0.45|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.51|0.45|0.01
71853337|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.47|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months||0.56|0.47|0.01
71853338|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.46||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.46|0.38|0.01
71680298|NCT01210495|142878545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907||||0.2872|TWO_SIDED|95.0|0.646|1.274||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio less than (\<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (\>) 1 indicated reduction to favor Placebo.|The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent \[%\] improvement in median OS).||1.274|0.646|0.2872
71821806|NCT02886728|143145985|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.83||0.67|TWO_SIDED|95.0|-1.3|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-1.3|0.67
71821807|NCT02886728|143145986|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.195|<|0.001|TWO_SIDED|95.0|-1.03|-0.27||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.27|-1.03|<0.001
71821808|NCT02886728|143145986|SUPERIORITY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.236||0.008|TWO_SIDED|95.0|-1.09|-0.16||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.16|-1.09|0.008
71680299|NCT01210495|142878546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.618||||0.0039|TWO_SIDED|95.0|0.438|0.871||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.871|0.438|0.0039
71680300|NCT01210495|142878547|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.172||||0.0914|TWO_SIDED|95.0|0.759|13.265||ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.|Cochran-Mantel-Haenszel||Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||13.265|0.759|0.0914
71680301|NCT01210495|142878548|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.006|TWO_SIDED|95.0|0.434|0.889||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio \<1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio \>1 indicated a reduction in favor of Placebo.|||0.889|0.434|0.006
71821809|NCT02886728|143145986|SUPERIORITY||Least Squares Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.242||0.006|TWO_SIDED|95.0|-1.14|-0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-1.14|0.006
71903734|NCT01100307|143328881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.0096|TWO_SIDED|95.0|0.65|4.65||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||4.65|0.65|0.0096
71903735|NCT01100307|143328881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.0001|TWO_SIDED|95.0|2.19|6.32||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.||6.32|2.19|<0.0001
71903736|NCT00406640|143328920|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.67||||0.243||95.0|-0.46|1.81|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared with ESC||1.81|-0.46|0.243
71903737|NCT00406640|143328921|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.608||||0.077||95.0|0.4|0.92|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.92|0.40|0.077
71680302|NCT01210495|142878550|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.65||||0.0025|TWO_SIDED|95.0|1.319|5.326||For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.|Cochran-Mantel-Haenszel||Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.|||5.326|1.319|0.0025
71821810|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|25.5|||<|0.001|TWO_SIDED|95.0|19.3|31.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||31.7|19.3|<0.001
71821811|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|20.6|||<|0.001|TWO_SIDED|95.0|12.8|28.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||28.5|12.8|<0.001
71821812|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|22.9|||<|0.001|TWO_SIDED|95.0|15.1|30.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||30.8|15.1|<0.001
71821813|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|28.8|||<|0.001|TWO_SIDED|95.0|22.1|35.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||35.6|22.1|<0.001
71821814|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|22.1|||<|0.001|TWO_SIDED|95.0|13.6|30.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||30.7|13.6|<0.001
71821815|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|19.0|||<|0.001|TWO_SIDED|95.0|10.5|27.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.5|10.5|<0.001
71821816|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|10.8|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||23.8|10.8|<0.001
71821817|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|12.6||||0.002|TWO_SIDED|95.0|4.5|20.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||20.7|4.5|0.002
71821818|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|12.1||||0.002|TWO_SIDED|95.0|4.0|20.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.1|4.0|0.002
71821819|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|7.2||||0.016|TWO_SIDED|95.0|0.9|13.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||13.5|0.9|0.016
71821820|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|5.2||||0.18|TWO_SIDED|95.0|-2.7|13.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.0|-2.7|0.18
71821821|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|7.9||||0.03|TWO_SIDED|95.0|0.3|15.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.6|0.3|0.030
71821822|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|13.2|||<|0.001|TWO_SIDED|95.0|6.7|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||19.7|6.7|<0.001
71821823|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|11.7||||0.003|TWO_SIDED|95.0|3.7|19.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.6|3.7|0.003
71853339|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57||||0.01|TWO_SIDED|95.0|0.49|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.49|0.01
71821824|NCT02886728|143145987|SUPERIORITY||Difference in Response Rates|13.0|||<|0.001|TWO_SIDED|95.0|5.1|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||20.8|5.1|<0.001
71821825|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|10.1|||<|0.001|TWO_SIDED|95.0|6.2|13.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||13.9|6.2|<0.001
71821826|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|6.3||||0.001|TWO_SIDED|95.0|1.7|10.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||10.9|1.7|0.001
71821827|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|13.3|||<|0.001|TWO_SIDED|95.0|7.7|18.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||18.9|7.7|<0.001
71821828|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|20.0|||<|0.001|TWO_SIDED|95.0|14.5|25.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.4|14.5|<0.001
71680303|NCT01210495|142878559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.89||||0.0006|TWO_SIDED|95.0|-18.7|-5.08||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.08|-18.70|0.0006
71680304|NCT01210495|142878560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6||||0.0014|TWO_SIDED|95.0|-12.27|-2.94||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.94|-12.27|0.0014
71680305|NCT01210495|142878561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|||<|0.0001|TWO_SIDED|95.0|-4.76|-1.78||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.78|-4.76|<0.0001
71821829|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|11.4|||<|0.001|TWO_SIDED|95.0|4.8|18.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.0|4.8|<0.001
71821830|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|9.4|23.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.2|9.4|<0.001
71853340|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.51||||0.01|TWO_SIDED|95.0|0.33|0.76||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.76|0.33|0.01
71853341|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.39|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates event rates were presented per 1,000 person-months.||0.45|0.39|0.01
71853342|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.42||||0.01|TWO_SIDED|95.0|0.38|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.47|0.38|0.01
71853343|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.37||||0.01|TWO_SIDED|95.0|0.34|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.41|0.34|0.01
71853344|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.58||||0.05|TWO_SIDED|95.0|0.49|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.68|0.49|0.05
71903738|NCT00406640|143328922|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.571||||0.0054||95.0|0.39|0.85|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||0.85|0.39|0.0054
71680306|NCT01210495|142878562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.0001|TWO_SIDED|95.0|-5.26|-2.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-2.21|-5.26|<0.0001
71680307|NCT01210495|142878562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.1642|TWO_SIDED|95.0|-3.07|0.52||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.52|-3.07|0.1642
71821831|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|24.8|||<|0.001|TWO_SIDED|95.0|18.1|31.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||31.5|18.1|<0.001
71821832|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|16.1|||<|0.001|TWO_SIDED|95.0|7.7|24.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||24.5|7.7|<0.001
71821833|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|17.3|||<|0.001|TWO_SIDED|95.0|9.0|25.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||25.7|9.0|<0.001
71903739|NCT00406640|143328923|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12||||0.26||95.0|-0.09|0.33|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|DVS SR compared with ESC||0.33|-0.09|0.260
71903740|NCT00406640|143328924|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14||||0.239||95.0|-0.09|0.37|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|||0.37|-0.09|0.239
71903741|NCT00406640|143328925|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.37||||0.516||95.0|-0.75|1.49|||Mixed Models Analysis|Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared to ESC||1.49|-0.75|0.516
71903742|NCT00406640|143328926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.01||||0.635||95.0|-0.03|0.06|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.|DVS SR adjusted mean change minus ESC adjusted mean change|DVS SR compared to ESC||0.06|-0.03|0.635
71903743|NCT00406640|143328927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.702||95.0|0.63|2.0|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.00|0.63|0.702
71903744|NCT00406640|143328928|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.34||||0.234||95.0|0.83|2.16|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.||2.16|0.83|0.234
71903745|NCT00406640|143328932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: end of therapy||||0.927
71903746|NCT00406640|143328932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.055||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 1 week of taper||||0.055
71903747|NCT00406640|143328932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after 2 weeks of taper||||0.025
71903748|NCT00406640|143328932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.653||95.0|||||t-test, 2 sided|||DVS SR vs. ESC: after \> 2 weeks of taper||||0.653
71903749|NCT00755846|143328943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.135||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
71903750|NCT00755846|143328943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.171||0.004||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
71903751|NCT00755846|143328943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.176||0.017||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
71921817|NCT04269629|143364759|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.11||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more frequent SR under VIT.||||0.11
71853345|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28||||0.01|TWO_SIDED|95.0|0.15|0.52||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/Rad event rates were presented per 1,000 person-months.||0.52|0.15|0.01
71853346|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.01|TWO_SIDED|95.0|0.66|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.85|0.66|0.01
71853347|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.83||||0.02|TWO_SIDED|95.0|0.7|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.97|0.70|0.02
71853348|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.88|0.58|0.01
71853349|NCT00113880|143220282|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.47||||0.01|TWO_SIDED|95.0|0.27|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.||0.78|0.27|0.01
71853350|NCT00113880|143220283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.04|TWO_SIDED|95.0|0.0|0.82||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Encephalitis/encephalopathy event rates were presented per 1,000 person-months.||0.82|0.00|0.04
71853351|NCT00113880|143220284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
71853352|NCT00113880|143220284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
71853353|NCT00113880|143220284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
71853354|NCT00113880|143220284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
71903752|NCT00755846|143328943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.17||0.001||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.001
71921818|NCT01997333|143364765|SUPERIORITY|||||||0.761|||||||Log Rank|Stratified log rank test.||||||0.761
71853355|NCT00113880|143220285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.01|TWO_SIDED|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.91|0.47|0.01
71921819|NCT01997333|143364766|SUPERIORITY|||||||0.264|||||||Cochran-Mantel-Haenszel|Adjusted for stratification factors.||||||0.264
71921820|NCT01997333|143364768|SUPERIORITY|||||||0.726|||||||Log Rank|Stratified log rank.||||||0.726
71821834|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|15.9|||<|0.001|TWO_SIDED|95.0|8.9|22.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||22.8|8.9|<0.001
71821835|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|11.3||||0.006|TWO_SIDED|95.0|2.7|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||20.0|2.7|0.006
71821836|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|12.4||||0.002|TWO_SIDED|95.0|3.9|21.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||21.0|3.9|0.002
71821837|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|12.0|||<|0.001|TWO_SIDED|95.0|5.1|19.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||19.0|5.1|<0.001
71821838|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|7.0||||0.09|TWO_SIDED|95.0|-1.7|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||15.7|-1.7|0.090
71821839|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|10.0||||0.014|TWO_SIDED|95.0|1.4|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||18.6|1.4|0.014
71821840|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|13.9|||<|0.001|TWO_SIDED|95.0|7.0|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||20.9|7.0|<0.001
71821841|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|11.1||||0.008|TWO_SIDED|95.0|2.5|19.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||19.7|2.5|0.008
71821842|NCT02886728|143145988|SUPERIORITY||Difference in Response Rates|13.1||||0.001|TWO_SIDED|95.0|4.6|21.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||21.6|4.6|0.001
71821843|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|2.4||||0.018|TWO_SIDED|95.0|0.3|4.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||4.5|0.3|0.018
71921821|NCT01535638|143364771|SUPERIORITY_OR_OTHER||Ratio (%)|123.4|STANDARD_DEVIATION|17.1|||TWO_SIDED|90.0|108.0|141.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|Relative bioavailability comparison of Deleobuvir Trial Formulation II (reference) and Deleobuvir Final Formulation (test) in pairwise comparison. (reference : test)||141.1|108.0|
71821844|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|1.2||||0.17|TWO_SIDED|95.0|-1.2|3.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||3.6|-1.2|0.17
71821845|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|3.6||||0.004|TWO_SIDED|95.0|0.3|6.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||6.8|0.3|0.004
71821846|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|9.1|||<|0.001|TWO_SIDED|95.0|5.2|13.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||13.1|5.2|<0.001
71821847|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|2.4||||0.18|TWO_SIDED|95.0|-1.7|6.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||6.6|-1.7|0.18
71821848|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|7.6|||<|0.001|TWO_SIDED|95.0|2.5|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||12.6|2.5|<0.001
71821849|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|13.9|25.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||25.5|13.9|<0.001
71821850|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|6.6|21.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||21.1|6.6|<0.001
71821851|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|15.8|||<|0.001|TWO_SIDED|95.0|8.5|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||23.1|8.5|<0.001
71821852|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|17.8|||<|0.001|TWO_SIDED|95.0|11.2|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||24.4|11.2|<0.001
71821853|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.9|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||22.4|5.9|<0.001
71821854|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|14.0|||<|0.001|TWO_SIDED|95.0|5.8|22.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.2|5.8|<0.001
71680308|NCT01210495|142878562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.4759|TWO_SIDED|95.0|-1.8|0.84||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||0.84|-1.80|0.4759
71680309|NCT01210495|142878562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07||||0.0288|TWO_SIDED|95.0|-3.92|-0.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.21|-3.92|0.0288
71680310|NCT01210495|142878563|SUPERIORITY||Mean Difference (Final Values)|-4.96||||0.0011|TWO_SIDED|95.0|-7.93|-1.99||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.99|-7.93|0.0011
71821855|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|13.7|||<|0.001|TWO_SIDED|95.0|6.9|20.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||20.5|6.9|<0.001
71821856|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|5.0||||0.2|TWO_SIDED|95.0|-3.3|13.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||13.3|-3.3|0.20
71821857|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|7.3||||0.056|TWO_SIDED|95.0|-1.0|15.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||15.7|-1.0|0.056
71821858|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|18.0|||<|0.001|TWO_SIDED|95.0|11.3|24.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||24.8|11.3|<0.001
71821859|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|10.3||||0.01|TWO_SIDED|95.0|1.9|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.6|1.9|0.010
71821860|NCT02886728|143145989|SUPERIORITY||Difference in Response Rates|15.4|||<|0.001|TWO_SIDED|95.0|7.0|23.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.8|7.0|<0.001
71821861|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.031|<|0.001|TWO_SIDED|95.0|-0.29|-0.17||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.17|-0.29|<0.001
71680311|NCT01210495|142878564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.45|||<|0.0001|TWO_SIDED|95.0|-15.49|-5.42||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-5.42|-15.49|<0.0001
71680312|NCT01210495|142878565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.252||||0.9182|TWO_SIDED|95.0|0.923|1.698||The p-value is from a 1-sided log-rank test.|1-sided, unstratified log-rank test||Assuming proportional hazards, a hazard ratio \<1 indicates reduction in hazard rate to favor Axitinib, hazard ratio \>1 indicates reduction to favor Placebo.|||1.698|0.923|0.9182
71680313|NCT01210495|142878566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.0024|TWO_SIDED|95.0|-0.2|-0.04|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-0.04|-0.20|0.0024
71821862|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.28|-0.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.13|-0.28|<0.001
71821863|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.038|<|0.001|TWO_SIDED|95.0|-0.24|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.24|<0.001
71821864|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.035|<|0.001|TWO_SIDED|95.0|-0.35|-0.22||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.22|-0.35|<0.001
71821865|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.043|<|0.001|TWO_SIDED|95.0|-0.23|-0.06||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.06|-0.23|<0.001
71821866|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.042|<|0.001|TWO_SIDED|95.0|-0.29|-0.12||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.12|-0.29|<0.001
71821867|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.039|<|0.001|TWO_SIDED|95.0|-0.35|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.20|-0.35|<0.001
71821868|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.28|-0.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.09|-0.28|<0.001
71853356|NCT00113880|143220285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34||||0.01|TWO_SIDED|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.57|0.21|0.01
71853357|NCT00113880|143220285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.01|TWO_SIDED|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.77|0.47|0.01
71853358|NCT00113880|143220285|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.||0.48|0.23|0.01
71853359|NCT00113880|143220286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.01|TWO_SIDED|95.0|0.57|0.73||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.73|0.57|0.01
71853360|NCT00113880|143220286|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.36|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.51|0.36|0.01
71903753|NCT00755846|143328943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.174||0.003||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.003
71903754|NCT00755846|143328943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.173||0.307||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.307
71853361|NCT00113880|143220287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.01|TWO_SIDED|95.0|0.26|0.33||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.33|0.26|0.01
71903755|NCT00755846|143328944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.106||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.004
71903756|NCT00755846|143328944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.134||0.017||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.017
71903757|NCT00755846|143328944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.138||0.016||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.016
71903758|NCT00755846|143328944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.134||0.005||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.005
71903759|NCT00755846|143328944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.137||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.008
71903760|NCT00755846|143328944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.136||0.321||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.||||0.321
71921822|NCT01535638|143364771|SUPERIORITY_OR_OTHER||Ratio (%)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|88.6|136.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (reference : test)||136.1|88.6|
71921823|NCT01535638|143364772|SUPERIORITY_OR_OTHER||Ratio (%)|122.5|STANDARD_DEVIATION|16.1|||TWO_SIDED|90.0|107.9|139.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation (test) and Deleobuvir Trial Formulation II (reference) in pairwise comparison. (test : reference)||139.1|107.9|
71853362|NCT00113880|143220287|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.01|TWO_SIDED|95.0|0.13|0.18||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.18|0.13|0.01
71853363|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.04|TWO_SIDED|95.0|0.03|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||0.93|0.03|0.04
71680314|NCT01210495|142878567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03||||0.0193|TWO_SIDED|95.0|-12.91|-1.15|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||-1.15|-12.91|0.0193
71680315|NCT00454818|142878583|SUPERIORITY_OR_OTHER|||||||0.078||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.078
71680316|NCT00454818|142878583|SUPERIORITY_OR_OTHER|||||||0.515||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.515
71680317|NCT00454818|142878583|SUPERIORITY_OR_OTHER|||||||0.098||||||The a priori threshold for statistical significance was P \< 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided|||||||0.098
71821869|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.048|<|0.001|TWO_SIDED|95.0|-0.26|-0.07||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.07|-0.26|<0.001
71821870|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.043||0.002|TWO_SIDED|95.0|-0.22|-0.05||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.05|-0.22|0.002
71821871|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.23|TWO_SIDED|95.0|-0.17|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.17|0.23
71821872|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.052||0.24|TWO_SIDED|95.0|-0.16|0.04||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.04|-0.16|0.24
71821873|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.045|<|0.001|TWO_SIDED|95.0|-0.25|-0.08||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.25|<0.001
71821874|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.054||0.077|TWO_SIDED|95.0|-0.2|0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.01|-0.20|0.077
71853364|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.02|TWO_SIDED|95.0|0.4|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.92|0.40|0.02
71853365|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49||||0.01|TWO_SIDED|95.0|0.28|0.84||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.84|0.28|0.01
71680318|NCT00767039|142878599|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|t-test, 2 sided|||Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive \>/= 3 days were included in the analysis.||||< 0.05
71680319|NCT00767039|142878600|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.43|||<|0.05|TWO_SIDED|95.0|0.19|0.95|||Mantel Haenszel|||||0.95|0.19|<0.05
71680320|NCT00767039|142878601|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
71680321|NCT00767039|142878602|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.49|||<|0.05|TWO_SIDED|95.0|0.25|0.96|||Mantel Haenszel|||||0.96|0.25|<0.05
71680322|NCT00767039|142878603|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||<|0.01|TWO_SIDED|95.0|1.29|4.38|||Mantel Haenszel|||||4.38|1.29|<0.01
71680323|NCT00767039|142878604|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>0.05
71821875|NCT02886728|143145990|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.054||0.039|TWO_SIDED|95.0|-0.22|-0.01||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.01|-0.22|0.039
71903761|NCT00755846|143328945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71903762|NCT00755846|143328945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.5|STANDARD_ERROR_OF_MEAN|8.4|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71903763|NCT00755846|143328945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|8.68||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
71903764|NCT00755846|143328945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.38|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71903765|NCT00755846|143328945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|8.57||0.057||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.057
71903766|NCT00755846|143328945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|8.56||0.156||95.0||||No multiplicity adjustments|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.156
71903767|NCT00755846|143328946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.9|STANDARD_ERROR_OF_MEAN|7.05|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71903768|NCT00755846|143328946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.4|STANDARD_ERROR_OF_MEAN|8.91||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.001
71921824|NCT01535638|143364772|SUPERIORITY_OR_OTHER||Ratio (%)|107.6|STANDARD_DEVIATION|35.0|||TWO_SIDED|90.0|83.1|139.4|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (test : reference)||139.4|83.1|
71921825|NCT00819052|143364782|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12%|Cochran's statistic|1.0||||||95.0|-4.3|6.2|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||6.2|-4.3|
71921826|NCT00819052|143364795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.64||||0.7587||95.0|-34.34|25.05|||ANCOVA|Means adjusted for background ARV (Antiretroviral) stratum||||25.05|-34.34|0.7587
71921827|NCT01277666|143364831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.546|TWO_SIDED|95.0|-6.1|11.0|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg once daily||11.0|-6.1|0.546
71680324|NCT00767039|142878605|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
71853366|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.1|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.||0.78|0.10|0.02
71853367|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.78||||0.02|TWO_SIDED|95.0|0.63|0.96||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.96|0.63|0.02
71853368|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.69||||0.03|TWO_SIDED|95.0|0.5|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.97|0.50|0.03
71853369|NCT00113880|143220288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01||95.0|0.21|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.||0.79|0.21|0.01
71853370|NCT00113880|143220289|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.95||||0.02|TWO_SIDED|95.0|1.14|3.34||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.||3.34|1.14|0.02
71853371|NCT00113880|143220289|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.||||0.02
71853372|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.01|TWO_SIDED|95.0|0.15|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.57|0.15|0.01
71853373|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.03|TWO_SIDED|95.0|0.12|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.92|0.12|0.03
71853374|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.13|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.74|0.13|0.01
71853375|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.04|TWO_SIDED|95.0|0.55|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.99|0.55|0.04
71853376|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.04|TWO_SIDED|95.0|0.14|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.||0.93|0.14|0.04
71853377|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.02|TWO_SIDED|95.0|0.71|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.97|0.71|0.02
71680325|NCT00767039|142878606|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).||||<0.05
71680326|NCT00767039|142878607|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
71680327|NCT00767039|142878608|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.44|||>|0.05|TWO_SIDED|95.0|0.71|2.89|||Mantel Haenszel|||||2.89|0.71|>0.05
71903769|NCT00755846|143328946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|9.2||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.008
71903770|NCT00755846|143328946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.5|STANDARD_ERROR_OF_MEAN|8.88|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71680328|NCT00767039|142878609|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||>|0.05|TWO_SIDED|90.0|0.84|2.63|||Mantel Haenszel|||||2.63|0.84|>0.05
71680329|NCT01472757|142878625|SUPERIORITY|||||||0.013|||||||ANCOVA|||||||0.013
71680330|NCT01472757|142878625|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
71680331|NCT01472757|142878625|SUPERIORITY||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA|||||||<0.001
71680332|NCT01472757|142878626|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71680333|NCT01472757|142878626|SUPERIORITY|||||||0.006|||||||Fisher Exact|||||||0.006
71680334|NCT01472757|142878626|SUPERIORITY|||||||0.011|||||||Fisher Exact|||||||0.011
71853378|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.01|TWO_SIDED|95.0|0.57|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.||0.92|0.57|0.01
71853379|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.01|TWO_SIDED|95.0|0.22|0.61||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.61|0.22|0.01
71680335|NCT01472757|142878627|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71680336|NCT01472757|142878627|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71680337|NCT01472757|142878627|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
71853380|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.01|TWO_SIDED|95.0|0.16|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.68|0.16|0.01
71853381|NCT00113880|143220290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.03|TWO_SIDED|95.0|0.0|0.82|||Fisher Exact||Population: 18-49, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.82|0.00|0.03
71853382|NCT00113880|143220291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.58|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.58|0.01
71853383|NCT00113880|143220291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.01|TWO_SIDED|95.0|0.49|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.49|0.01
71853384|NCT00113880|143220291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.01|TWO_SIDED|95.0|0.61|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.92|0.61|0.01
71680338|NCT02961062|142878640|SUPERIORITY||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|0.0||0.005|TWO_SIDED|90.0|-17.54|-4.71|||Kenward-Roger method|||||-4.71|-17.54|0.005
71680339|NCT02961062|142878641|SUPERIORITY||Median Difference (Final Values)|-8.56|STANDARD_ERROR_OF_MEAN|3.37||0.017|TWO_SIDED|90.0|-14.29|-2.83|||Kenward-Roger method|||||-2.83|-14.29|0.017
71680340|NCT01565369|142878699|SUPERIORITY_OR_OTHER||Fleiss' kappa|0.8547|STANDARD_ERROR_OF_MEAN|0.0282|<|0.0001||95.0||||evaluated at the .05 significance level|Fleiss' kappa|||Fleiss' kappa||||<0.0001
71680341|NCT00606554|142878708|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.60
71680342|NCT00606554|142878712|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71680343|NCT00606554|142878715|SUPERIORITY_OR_OTHER|||||||0.9|||||||Chi-squared|||||||0.90
71680344|NCT04545567|142878729|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71680345|NCT04545567|142878730|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71903771|NCT00755846|143328946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|9.09||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
71903772|NCT00755846|143328946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|9.07||0.073||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.073
71680346|NCT04545567|142878731|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71680347|NCT04545567|142878732|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71680348|NCT04545567|142878733|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71680349|NCT04545567|142878734|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
71680350|NCT04545567|142878735|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71680351|NCT04545567|142878736|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71903773|NCT00755846|143328947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|5.85|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71903774|NCT00755846|143328947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.2|STANDARD_ERROR_OF_MEAN|7.37||0.01||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.010
71680352|NCT04545567|142878737|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71680353|NCT04545567|142878738|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71680354|NCT04545567|142878739|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71680355|NCT04545567|142878740|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71680356|NCT04545567|142878741|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71680357|NCT04545567|142878742|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.05|TWO_SIDED||||||t-test, 1 sided|||||||0.05
71680358|NCT04545567|142878743|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71680359|NCT04545567|142878744|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71680360|NCT04545567|142878745|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71680361|NCT04545567|142878746|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71680362|NCT04545567|142878747|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
71680363|NCT04545567|142878748|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71680364|NCT03979807|142878749|OTHER||Adjusted Hazard Ratio|1.11|||||TWO_SIDED|95.0|1.06|1.17|||||Cox proportional hazard model. 'Treatment' is the only Independent variable used to estimate the hazard ratios. Umeclidinium/Vilanterol is Reference Group.|||1.17|1.06|
71680365|NCT02754674|142878764|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71680366|NCT02754674|142878765|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71680367|NCT02754674|142878766|SUPERIORITY|Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.|||||>|0.05|||||||t-test, 2 sided|||We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson's Chi-square test or Fisher's exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.||||>0.05
71680368|NCT02754674|142878767|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71680369|NCT02754674|142878768|SUPERIORITY|||||||0.054|||||||t-test, 2 sided|||||||0.054
71680370|NCT02419612|142878769|SUPERIORITY||Least Squares (LS) Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.099|<|0.001|TWO_SIDED|95.0|-0.57|-0.18|||Mixed Models Analysis|Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.||||-0.18|-0.57|<0.001
71680371|NCT02419612|142878770|SUPERIORITY||LS Mean Difference|-4.06|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-4.84|-3.28|||Mixed Models Analysis|Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.||||-3.28|-4.84|<0.001
71680372|NCT02419612|142878771|SUPERIORITY||Odds Ratio (OR)|1.5||||0.044||95.0|1.01|2.29|||Regression, Logistic|Adjusted for baseline HbA1c value||||2.29|1.01|0.044
71680373|NCT02419612|142878772|SUPERIORITY||LS Mean Difference|-3.6|STANDARD_ERROR_OF_MEAN|1.35||0.007|TWO_SIDED|95.0|-6.3|-1.0|||Mixed Models Analysis|Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction||||-1.0|-6.3|0.007
71853385|NCT00113880|143220291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.52|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.91|0.52|0.01
71853386|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41||||0.01|TWO_SIDED|95.0|0.33|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.51|0.33|0.01
71853387|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37||||0.01|TWO_SIDED|95.0|0.26|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.55|0.26|0.01
71853388|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42||||0.01|TWO_SIDED|95.0|0.31|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.56|0.31|0.01
71853389|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.29||||0.02|TWO_SIDED|95.0|0.26|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.||0.91|0.26|0.02
71853390|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01||95.0|0.37|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.55|0.37|0.01
71903775|NCT00755846|143328947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.8|STANDARD_ERROR_OF_MEAN|7.71||0.002||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.002
71903776|NCT00755846|143328947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|7.33||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
71921828|NCT01277666|143364831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.648|TWO_SIDED|95.0|-6.5|10.7|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg twice daily||10.7|-6.5|0.648
71921829|NCT01277666|143364832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.592|TWO_SIDED|95.0|-8.8|4.8|||Mantel Haenszel|||||4.8|-8.8|0.592
71921830|NCT01277666|143364832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.475|TWO_SIDED|95.0|-9.2|4.4|||Mantel Haenszel|||||4.4|-9.2|0.475
71853391|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.01|TWO_SIDED|95.0|0.35|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.67|0.35|0.01
71853392|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.01|TWO_SIDED|95.0|0.33|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.56|0.33|0.01
71853393|NCT00113880|143220292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46||||0.01|TWO_SIDED|95.0|0.25|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.||0.85|0.25|0.01
71853394|NCT00113880|143220293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.47||||0.01|TWO_SIDED|95.0|0.32|0.69||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.69|0.32|0.01
71680374|NCT02419612|142878773|SUPERIORITY||Hazard Ratio (HR)|0.15||||0.002|TWO_SIDED|95.0|0.04|0.5||This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.|Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.50|0.04|0.002
71921831|NCT01277666|143364833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.415|TWO_SIDED|95.0|-4.4|10.3|||Mantel Haenszel|||||10.3|-4.4|0.415
71921832|NCT01277666|143364833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.354|TWO_SIDED|95.0|-3.9|10.9|||Mantel Haenszel|||||10.9|-3.9|0.354
71921833|NCT01277666|143364834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-5.2|5.2|||Mantel Haenszel|||||5.2|-5.2|0.985
71921834|NCT01277666|143364834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.709|TWO_SIDED|95.0|-6.1|4.1|||Mantel Haenszel|||||4.1|-6.1|0.709
71921835|NCT01277666|143364835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.633|TWO_SIDED|95.0|-6.5|10.4|||Mantel Haenszel|||||10.4|-6.5|0.633
71921836|NCT01277666|143364835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.889|TWO_SIDED|95.0|-7.8|9.0|||Mantel Haenszel|||||9.0|-7.8|0.889
71921837|NCT01277666|143364836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0||||0.541|TWO_SIDED|95.0|-8.1|4.2|||Mantel Haenszel|||||4.2|-8.1|0.541
71921838|NCT01277666|143364836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.43|TWO_SIDED|95.0|-8.5|3.7|||Mantel Haenszel|||||3.7|-8.5|0.430
71921839|NCT01277666|143364837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13|STANDARD_ERROR_OF_MEAN|2.426||0.642|TWO_SIDED|95.0|-5.89|3.64||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||3.64|-5.89|0.642
71921840|NCT01277666|143364837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|2.652||0.898|TWO_SIDED|95.0|-5.55|4.87||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||4.87|-5.55|0.898
71921841|NCT01277666|143364837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.37|STANDARD_ERROR_OF_MEAN|2.467||0.173|TWO_SIDED|95.0|-1.48|8.21||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8||8.21|-1.48|0.173
71921842|NCT01277666|143364837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.85|STANDARD_ERROR_OF_MEAN|2.697||0.493|TWO_SIDED|95.0|-3.45|7.15||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12||7.15|-3.45|0.493
71921843|NCT00982111|143364839|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9561|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.9561
71921844|NCT00982111|143364840|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.6647|TWO_SIDED|95.0|0.8|1.16|||Log Rank|||||1.16|0.80|0.6647
71921845|NCT00982111|143364841|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.7945|TWO_SIDED|95.0|0.68|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.68|0.7945
71921846|NCT00982111|143364842|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.18||||0.0459|TWO_SIDED|95.0|1.0|1.39|||Log Rank|||||1.39|1.00|0.0459
71921847|NCT03702166|143364855|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|Multiple t-tests with Bonferroni corrections for multiple comparisons||||||0.01
71921848|NCT03702166|143364857|SUPERIORITY|||||||0.038|||||||t-test, 1 sided|Multiple t-tests, with Bonferroni corrections for multiple comparisons,||||||0.038
71921849|NCT03702166|143364859|SUPERIORITY|||||||0.031||||||Multiple t-tests, with Bonferroni corrections for multiple comparisons|t-test, 1 sided|||||||0.031
71921850|NCT01657903|143364861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.15|||<|0.0001|TWO_SIDED|95.0|34.42|47.89||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.89|34.42|<0.0001
71921851|NCT01657903|143364861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|41.28|||<|0.0001|TWO_SIDED|95.0|34.51|48.06||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||48.06|34.51|<0.0001
71921852|NCT01657903|143364861|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|40.83|||<|0.0001|TWO_SIDED|95.0|34.06|47.61||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.||47.61|34.06|<0.0001
71921853|NCT01657903|143364862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.36|||<|0.0001|TWO_SIDED|95.0|6.01|12.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.72|6.01|<0.0001
71921854|NCT01657903|143364862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.45|||<|0.0001|TWO_SIDED|95.0|6.07|12.82||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||12.82|6.07|<0.0001
71821876|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
71821877|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
71821878|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
71821879|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-7.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-7.0|<0.001
71821880|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.0|<0.001
71821881|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
71821882|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
71821883|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
71821884|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.001|TWO_SIDED|95.0|-6.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-6.0|<0.001
71903777|NCT00755846|143328947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|7.44||0.006||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.006
71821885|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71821886|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.005|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.005
71853395|NCT00113880|143220293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.01|TWO_SIDED|95.0|0.17|0.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.||0.54|0.17|0.01
71853396|NCT01636258|143220318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.1||0.72|TWO_SIDED|95.0|-1.4|2.0||P-value less than 0.05 considered statistically significant a priori. No multiple comparison adjustment made.|t-test, 2 sided|||No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||2.0|-1.4|0.72
71853397|NCT01636258|143220319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.||||0.31
71903778|NCT00755846|143328947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|7.45||0.117||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.117
71903779|NCT00755846|143328948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.3|STANDARD_ERROR_OF_MEAN|6.6||0.014||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.014
71903780|NCT00755846|143328948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|8.35||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.136
71921855|NCT01657903|143364862|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.66|||<|0.0001|TWO_SIDED|95.0|8.28|15.03||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.||15.03|8.28|<0.0001
71921856|NCT02155725|143364945|SUPERIORITY||Odds Ratio (OR)|0.9889||||0.9563|TWO_SIDED|95.0|0.6633|1.4744|||Regression, Logistic|||||1.4744|0.6633|0.9563
71921857|NCT02155725|143364946|SUPERIORITY||Odds Ratio (OR)|1.0064||||0.9786|TWO_SIDED|95.0|0.6321|1.6022|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as administration of 2 units of RBCs.||1.6022|0.6321|0.9786
71921858|NCT02155725|143364947|SUPERIORITY||Odds Ratio (OR)|1.0169||||0.9474|TWO_SIDED|95.0|0.6177|1.6741|||Regression, Logistic|||Failure on individual component of the primary endpoint defined as a loss of at least 4 g/dL of Hb.||1.6741|0.6177|0.9474
71921859|NCT00842829|143364948|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper limit of the 90% CI was \<8%.|Mean Difference (Net)|-6.3|||||ONE_SIDED|95.0||1.4|||||The upper bound of the 2-sided 90% confidence interval is equivalent to the upper bound of the 1-sided 95% confidence interval.|Treatment comparison difference (100 mcg - 200 mcg)||1.4||
71921860|NCT03091920|143364986|OTHER|No statistical testing was performed.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-14.2|12.4|||||LS mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1 postdose AM 1 hour||12.4|-14.2|
71853398|NCT01636258|143220320|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71853399|NCT01636258|143220321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71853400|NCT01763346|143220323|SUPERIORITY|||||||0.05||||||35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.|General Linear Models|Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.||We selected a sample size that would allow detection of an effect size of \~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.||||0.05
71853401|NCT02186015|143220328|SUPERIORITY|A Wilcoxon signed rank test was performed.|||||<|0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in serum 25(OH)D from week 0 to week 8.||||<0.01
71853402|NCT02186015|143220329|SUPERIORITY|A Wilcoxon signed rank test was performed.||||||0.24|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in worst pain rating from week 0 to week 8.||||0.24
71853403|NCT02186015|143220330|SUPERIORITY|||||||0.09|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in fatigue score from week 0 to week 8.||||0.09
71921861|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|0.6|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-11.8|12.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 1 hour||12.9|-11.8|
71921862|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-13.9|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-30.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||2.8|-30.6|
71853404|NCT02186015|143220331|SUPERIORITY|||||||0.17|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in mood score from week 0 to week 8.||||0.17
71853405|NCT02186015|143220332|SUPERIORITY|||||||0.5|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in dominant handgrip strength from week 0 to week 8.||||0.50
71853406|NCT02186015|143220333|SUPERIORITY|||||||0.16|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in sleep quality assessment from week 0 to week 8.||||0.16
71853407|NCT02186015|143220334|SUPERIORITY|||||||0.75|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-breast score from week 0 to week 8.||||0.75
71853408|NCT02186015|143220335|SUPERIORITY|||||||0.19|||||||Wilcoxon signed rank test|||The null hypothesis is that there is 0 change in functional assessment of cancer therapy-endocrine score from week 0 to week 8.||||0.19
71853409|NCT05045638|143220357|OTHER||Ratio of GLSMs|1.6999|||||TWO_SIDED|90.0|1.186|2.4363||||||The ratios of geometric least squares means (GLSMs) and confidence intervals (CIs) were obtained by taking the exponential of the corresponding differences and CIs on the natural-log (ln) scale.||2.4363|1.1860|
71853410|NCT05045638|143220358|OTHER||Ratio of GLSMs|1.3389|||||TWO_SIDED|90.0|1.0334|1.7347||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.7347|1.0334|
71853411|NCT05045638|143220359|OTHER||Ratio of GLSMs|1.3382|||||TWO_SIDED|90.0|0.9856|1.8169||||||The ratios of GLSMs and CIs were obtained by taking the exponential of the corresponding differences and CIs on the ln scale.||1.8169|0.9856|
71853412|NCT02032420|143220370|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Repeated-measures MANOVA|The reported p value is for the effect of group assignment across three iterations of the assigned task.||||||<0.001
71853413|NCT02032420|143220371|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED||||||Repeated-measures MANOVA|The p value is for the effect of group assignment across three iterations of the assigned task.||||||0.004
71853414|NCT02032420|143220372|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.038
71853415|NCT02032420|143220373|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
71853416|NCT02332824|143220426|SUPERIORITY_OR_OTHER||LS Mean difference|-0.325|||<|0.0001|TWO_SIDED|95.0|-0.4845|-0.1649||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 5 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.1649|-0.4845|<0.0001
71853417|NCT02332824|143220426|SUPERIORITY_OR_OTHER||LS Mean difference|-0.469|||<|0.0001|TWO_SIDED|95.0|-0.6251|-0.3132||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 20 mg-placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3132|-0.6251|<0.0001
71853418|NCT02332824|143220426|SUPERIORITY_OR_OTHER||LS Mean difference|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.7897|-0.4711||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 40 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4711|-0.7897|<0.0001
71853419|NCT02332824|143220426|SUPERIORITY_OR_OTHER||LS Mean difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.8083|-0.4908||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 80 mg -placebo) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.4908|-0.8083|<0.0001
71853420|NCT02332824|143220426|SUPERIORITY_OR_OTHER||LS Mean difference|-0.53|||<|0.0001|TWO_SIDED|95.0|-0.6874|-0.3719||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (Candesartan cilexetil 8 mg -placebo group) in log-transformed UACR changes from baseline to the end of treatment period.|||-0.3719|-0.6874|<0.0001
71853421|NCT00914732|143220431|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.74|||||TWO_SIDED|97.5|-1.23|-0.25||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.25|-1.23|
71853422|NCT00914732|143220432|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.83|||||TWO_SIDED|97.5|-1.32|-0.33||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable||-0.33|-1.32|
71903781|NCT00755846|143328948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.1|STANDARD_ERROR_OF_MEAN|8.73||0.022||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.022
71903782|NCT00755846|143328948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.1|STANDARD_ERROR_OF_MEAN|8.26||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.004
71903783|NCT00755846|143328948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|8.48||0.04||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.040
71903784|NCT00755846|143328948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|8.47||0.378||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.378
71903785|NCT00755846|143328949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|5.37||0.718||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.718
71903786|NCT00755846|143328949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.8||0.346||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.346
71903787|NCT00755846|143328949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|7.13||0.901||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.901
71903788|NCT00755846|143328949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|6.79||0.851||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.851
71903789|NCT00755846|143328949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|6.86||0.825||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.825
71921863|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-15.5|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-31.0|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 4 hour||0|-31.0|
71853423|NCT00914732|143220433|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.05|||||TWO_SIDED|97.5|-0.43|0.52||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.52|-0.43|
71853424|NCT00914732|143220434|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.27|||||TWO_SIDED|97.5|-0.77|0.23||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.23|-0.77|
71853425|NCT00914732|143220437|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.34|||||TWO_SIDED|97.5|-0.3|0.71||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.71|-0.3|
71853426|NCT00914732|143220438|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation subcutaneously (Liquid SC Group) and IMVAMUNE® (2x10\^7 TCID50) formulation intradermally (Liquid ID) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Liquid ID was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|0.02|||||TWO_SIDED|97.5|-0.31|0.35||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.35|-0.31|
71853427|NCT00914732|143220439|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x10\^8 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x10\^8 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Liquid SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.35|||||TWO_SIDED|97.5|-0.74|0.04||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||0.04|-0.74|
71853428|NCT00914732|143220440|NON_INFERIORITY|The mean difference in log2 transformed peak titers between IMVAMUNE® (1x108 TCID50) liquid formulation (Liquid SC Group) and IMVAMUNE® (1x108 TCID50) lyophilized formulation (Lyophilized SC) with its associated two-sided 97.5% confidence interval (CI) was computed. If the upper limit of the 97.5% CI was less than 1, then the Lyophilized SC was considered non-inferior to the Lyophilized SC group. The difference and the CI are reported on the log2 scale.|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|97.5|-0.81|-0.12||||||The sample size calculations targeted at least 80% power to test non-inferiority for the primary and secondary immunogenicity end points for two investigational arms in reference to a control arm. Assuming a standard deviation of 2.8 for log2 peak PRNT or ELISA titer in each group, a non-inferiority margin of 2.0-fold, a type I error rate of 1.25% (Bonferroni adjusted for 2 comparisons), and drop-out rate of 10%, 165 participants in each group were to be enrolled to achieve 148 evaluable.||-0.12|-0.81|
71853429|NCT03840148|143220444|NON_INFERIORITY|If the lower limit of the 95% CI for the difference in response is greater than or equal to the non-inferiority margin of -15%, non-inferiority will be concluded. Further, if non-inferiority is concluded, superiority will be concluded if the lower limit of the 95% CI for the difference in response is greater than or equal to zero.|Miettinen and Nurminen|12.6||||0.0088|TWO_SIDED|95.0|3.1|22.2||P-value for superiority since the lower confidence interval is greater than 0 for the primary endpoint analysis.|Cochran-Mantel-Haenszel|||||22.2|3.1|0.0088
71853430|NCT03840148|143220445|OTHER||Miettinen and Nurminen|11.7|||||TWO_SIDED|95.0|2.9|21.0||||||||21.0|2.9|
71853431|NCT03840148|143220446|OTHER||Miettinen and Nurminen|4.5|||||TWO_SIDED|95.0|-2.6|12.6||||||||12.6|-2.6|
71853432|NCT03840148|143220447|OTHER||Miettinen and Nurminen|12.3|||||TWO_SIDED|95.0|3.0|21.8||||||||21.8|3.0|
71921864|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-23.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||3.9|-23.8|
71903790|NCT00755846|143328949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|6.94||0.843||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.843
71903791|NCT00755846|143328950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.88||0.069||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.069
71903792|NCT00755846|143328950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.6|STANDARD_ERROR_OF_MEAN|6.14||0.018||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.018
71903793|NCT00755846|143328950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_ERROR_OF_MEAN|6.47||0.258||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.258
71903794|NCT00755846|143328950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|6.13||0.299||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.299
71903795|NCT00755846|143328950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|6.27||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
71903796|NCT00755846|143328950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|6.32||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
71903797|NCT00755846|143328951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.689||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.689
71903798|NCT00755846|143328951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|1.05||0.742||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.742
71921865|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-16.0|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose AM 8 hour||9.7|-16.0|
71903799|NCT00755846|143328951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.22||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.220
71903800|NCT00755846|143328951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.05||0.348||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.348
71903801|NCT00755846|143328951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|1.06||0.627||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.627
71903802|NCT00755846|143328951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|1.06||0.418||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.418
71903803|NCT00755846|143328952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.95||0.617||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.617
71903804|NCT00755846|143328952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.2||0.052||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.052
71903805|NCT00755846|143328952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.28||0.906||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.906
71903806|NCT00755846|143328952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.19||0.628||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.628
71921866|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-26.2|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||8.6|-26.2|
71921867|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-19.7|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 predose PM||12.6|-19.7|
71921868|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-18.7|12.2||||||Day 1 postdose PM 1 hour||12.2|-18.7|
71921869|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|6.9|||TWO_SIDED|95.0|-18.7|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1 postdose PM||9.9|-18.7|
71903807|NCT00755846|143328952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.22||0.749||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.749
71903808|NCT00755846|143328952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.22||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.340
71853433|NCT03840148|143220448|OTHER||Miettinen and Nurminen|3.1|||||TWO_SIDED|95.0|-3.2|10.4||||||||10.4|-3.2|
71853434|NCT03840148|143220449|OTHER||Miettinen and Nurminen|-0.3|||||TWO_SIDED|95.0|-3.5|4.1||||||||4.1|-3.5|
71853435|NCT03840148|143220450|OTHER||Miettinen and Nurminen|1.6|||||TWO_SIDED|95.0|-4.1|8.5||||||||8.5|-4.1|
71853436|NCT03840148|143220451|OTHER||Miettinen and Nurminen|12.1|||||TWO_SIDED|95.0|2.2|21.9||||||||21.9|2.2|
71853437|NCT03840148|143220452|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.6|17.3||||||||17.3|-1.6|
71853438|NCT03840148|143220453|OTHER||Miettinen and Nurminen|9.9|||||TWO_SIDED|95.0|1.5|18.8||||||||18.8|1.5|
71853439|NCT03840148|143220454|OTHER||Miettinen and Nurminen|3.0|||||TWO_SIDED|95.0|-2.4|9.6||||||||9.6|-2.4|
71853440|NCT03840148|143220464|OTHER||Miettinen and Nurminen|3.5|||||TWO_SIDED|95.0|-2.3|10.5||||||||10.5|-2.3|
71853441|NCT03840148|143220465|OTHER||Miettinen and Nurminen|-1.1|||||TWO_SIDED|95.0|-3.1|1.7||||||||1.7|-3.1|
71853442|NCT03840148|143220466|OTHER||Miettinen and Nurminen|14.9|||||TWO_SIDED|95.0|5.0|24.9||||||||24.9|5.0|
71853443|NCT03840148|143220467|OTHER||Miettinen and Nurminen|12.7|||||TWO_SIDED|95.0|3.7|22.3||||||||22.3|3.7|
71853444|NCT03840148|143220468|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
71853445|NCT03840148|143220469|OTHER||Miettinen and Nurminen|7.7|||||TWO_SIDED|95.0|-1.9|17.7||||||||17.7|-1.9|
71853446|NCT03840148|143220474|OTHER||Miettinen and Nurminen|14.0|||||TWO_SIDED|95.0|3.8|24.3||||||||24.3|3.8|
71853447|NCT03840148|143220476|OTHER||Miettinen and Nurminen|1.7|||||TWO_SIDED|95.0|-3.1|7.3||||||||7.3|-3.1|
71853448|NCT03840148|143220477|OTHER||Miettinen and Nurminen|4.8|||||TWO_SIDED|95.0|-1.1|11.5||||||||11.5|-1.1|
71853449|NCT03840148|143220478|OTHER||Miettinen and Nurminen|8.2|||||TWO_SIDED|95.0|1.2|15.7||||||||15.7|1.2|
71853450|NCT00603278|143220512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|||<|0.001|TWO_SIDED|95.0|0.096|0.318|||ANCOVA|||||0.318|0.096|<0.001
71853451|NCT00603278|143220512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|||<|0.001|TWO_SIDED|95.0|0.127|0.349|||ANCOVA|||||0.349|0.127|<0.001
71853452|NCT00603278|143220512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.293|||<|0.001|TWO_SIDED|95.0|0.182|0.404|||ANCOVA|||||0.404|0.182|<0.001
71853453|NCT00603278|143220512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.279|||<|0.001|TWO_SIDED|95.0|0.167|0.392|||ANCOVA|||||0.392|0.167|<0.001
71853454|NCT00603278|143220512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|||<|0.001|TWO_SIDED|95.0|0.114|0.337|||ANCOVA|||||0.337|0.114|<0.001
71853455|NCT01207453|143220556|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed rank tests.||||0.42
71853456|NCT01207453|143220556|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.37
71853457|NCT01207453|143220557|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using the Wilcoxon signed-rank tests.||||0.39
71853458|NCT01207453|143220557|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.96
71853459|NCT01207453|143220558|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
71903809|NCT00755846|143328953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.31||0.269||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.269
71903810|NCT00755846|143328953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.46||0.076||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.076
71903811|NCT00755846|143328953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|5.66||0.867||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.867
71903812|NCT00755846|143328953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.4||0.169||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.169
71903813|NCT00755846|143328953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.45||0.645||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.645
71903814|NCT00755846|143328953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.51||0.351||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.351
71903815|NCT00755846|143328954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.3|STANDARD_ERROR_OF_MEAN|4.03||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.003
71903816|NCT00755846|143328954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|5.06|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||<0.001
71680375|NCT02419612|142878774|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||Time to treatment intensification was analyzed using a Cox proportional hazards model.||0.68|0.39|<0.001
71680376|NCT02419612|142878775|SUPERIORITY||Odds Ratio (OR)|2.1|STANDARD_ERROR_OF_MEAN|0.54||0.006|TWO_SIDED|95.0|1.23|3.42|||Regression, Logistic|Adjusted for baseline HbA1c value.||||3.42|1.23|0.006
71680377|NCT02419612|142878776|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.39|0.68|||Regression, Cox Proportional Hazards|||||0.68|0.39|<0.001
71821887|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71821888|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.063|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.063
71821889|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.6||0.64|TWO_SIDED|95.0|-1.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-1.0|0.64
71821890|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71853460|NCT01207453|143220558|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.83
71853461|NCT01207453|143220559|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.04
71853462|NCT01207453|143220559|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.04
71853463|NCT01207453|143220560|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.89
71853464|NCT01207453|143220560|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.44
71853465|NCT01207453|143220561|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.35
71853466|NCT01207453|143220561|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.34
71821891|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71853467|NCT01207453|143220562|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.||||0.72
71853468|NCT01207453|143220562|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was \< 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.||||0.82
71903817|NCT00755846|143328954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|5.26||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.103
71903818|NCT00755846|143328954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|4.98||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.009
71903819|NCT00755846|143328954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.14||0.034||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.034
71903820|NCT00755846|143328954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.1|STANDARD_ERROR_OF_MEAN|5.16||0.033||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.033
71903821|NCT00755846|143328955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|17.17||0.897||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.897
71903822|NCT00755846|143328955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|STANDARD_ERROR_OF_MEAN|21.85||0.557||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.557
71903823|NCT00755846|143328955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5|STANDARD_ERROR_OF_MEAN|22.85||0.616||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.616
71921870|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-18.2|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||1.3|-18.2|
71921871|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-14.8|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose AM||3.3|-14.8|
71921872|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-15.4|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-28.1|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||-2.8|-28.1|
71921873|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-9.4|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-21.1|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 1 hour||2.3|-21.1|
71921874|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.8|STANDARD_ERROR_OF_MEAN|8.1|||TWO_SIDED|95.0|-25.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||7.9|-25.6|
71921875|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.2|STANDARD_ERROR_OF_MEAN|7.5|||TWO_SIDED|95.0|-26.7|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose AM 4 hour||4.4|-26.7|
71853469|NCT02577315|143220563|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.1|||||TWO_SIDED|90.0|97.466|102.804|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.804|97.466|
71903824|NCT00755846|143328955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|21.73||0.679||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.679
71903825|NCT00755846|143328955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|21.94||0.697||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.697
71853470|NCT02577315|143220564|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|95.51|||||TWO_SIDED|90.0|89.29|102.16|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||102.16|89.29|
71853471|NCT02577315|143220565|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|102.71|||||TWO_SIDED|90.0|97.309|108.413|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||108.413|97.309|
71853472|NCT02577315|143220566|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|101.07|||||TWO_SIDED|90.0|95.565|106.902|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||106.902|95.565|
71853473|NCT02577315|143220567|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.3|||||TWO_SIDED|90.0|97.532|103.149|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||103.149|97.532|
71853474|NCT02577315|143220568|NON_INFERIORITY_OR_EQUIVALENCE|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|93.55|||||TWO_SIDED|90.0|82.86|105.61|||ANOVA|Analysis of variance (ANOVA) on log scale was used with subjects within sequences as random, whereas sequence, period and treatment as fixed effects.|Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination||105.61|82.86|
71853475|NCT04150250|143220579|SUPERIORITY||Difference in Median|-7.1||||0.2254|TWO_SIDED|95.0|-30.9|28.6||The threshold to define success on the primary efficacy endpoint at the final analysis is one-sided alpha = 0.0238.|Van Elteren test|Stratified by blood type group (O vs. Non-O)||||28.6|-30.9|0.2254
71853476|NCT04150250|143220580|SUPERIORITY||Difference in Median|-3.8||||0.2751|TWO_SIDED|95.0|-26.3|27.4|||Van Elteren test|Stratified by blood type group||||27.4|-26.3|0.2751
71853477|NCT04150250|143220582|SUPERIORITY||Difference|-11.3||||0.5145|TWO_SIDED|95.0|-44.1|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||21.6|-44.1|0.5145
71853478|NCT04150250|143220583|SUPERIORITY||Difference|-6.3||||0.2636|TWO_SIDED|95.0|-18.1|5.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||5.6|-18.1|0.2636
71853479|NCT04150250|143220584|SUPERIORITY||Difference in Median|1.1||||0.5992|TWO_SIDED|95.0|-4.5|7.8|||Van Elteren test|Stratified by blood type group||||7.8|-4.5|0.5992
71853480|NCT04150250|143220586|SUPERIORITY|||||||0.6527|||||||Log Rank|Stratified by blood type group||||||0.6527
71853481|NCT04150250|143220587|SUPERIORITY||Difference in Median|1.5||||0.5377|TWO_SIDED|95.0|-7.0|5.5|||Van Elteren test|Stratified by blood type group||||5.5|-7.0|0.5377
71853482|NCT04150250|143220588|SUPERIORITY||Difference|1.3||||0.8705|TWO_SIDED|95.0|-14.0|16.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group.||||16.5|-14.0|0.8705
71821892|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.095|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-2.0|0.095
71853483|NCT04150250|143220589|SUPERIORITY||Difference|-18.8||||0.1404|TWO_SIDED|95.0|-41.1|3.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test, stratified by blood type group||||3.6|-41.1|0.1404
71853484|NCT03322514|143220656|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71853485|NCT03322514|143220656|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.04
71903826|NCT00755846|143328955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|22.03||0.672||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.672
71903827|NCT00755846|143328956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|16.37||0.809||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.809
71903828|NCT00755846|143328956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|20.74||0.597||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.597
71903829|NCT00755846|143328956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|21.77||0.982||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.982
71903830|NCT00755846|143328956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.0|STANDARD_ERROR_OF_MEAN|20.62||0.358||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.358
71903831|NCT00755846|143328956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.1|STANDARD_ERROR_OF_MEAN|21.06||0.274||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.274
71921876|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-24.0|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||0.6|-24.0|
71921877|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-7.0|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.4|4.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 predose PM||4.4|-18.4|
71853486|NCT03322514|143220656|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.1
71853487|NCT03322514|143220657|SUPERIORITY|||||||0.8|||||||ANOVA|||||||0.8
71853488|NCT03322514|143220657|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
71853489|NCT03322514|143220657|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.3
71853490|NCT03322514|143220658|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
71853491|NCT03322514|143220658|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||Baseline to 12 weeks||||0.4
71853492|NCT03322514|143220658|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||baseline to 12 weeks||||0.7
71853493|NCT01184859|143220659|SUPERIORITY_OR_OTHER|||||||0.211||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.211
71853494|NCT01184859|143220659|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.010
71821893|NCT02886728|143145991|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71821894|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71821895|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.002|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|0.002
71821896|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71821897|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
71821898|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71821899|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|<0.001
71821900|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-3.0|<0.001
71821901|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71903832|NCT00755846|143328956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|21.06||0.554||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.||||0.554
71903833|NCT02669862|143328965|OTHER|||||||0.555|||||||ANCOVA|Baseline values were the covariate||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.555
71903834|NCT02669862|143328965|OTHER|||||||0.009||||||PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.|ANCOVA|||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."||||0.009
71903835|NCT02669862|143328967|OTHER|||||||0.9313||||||Not adjusted for multiple comparisons|Chi-squared|||PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group||||0.9313
71821902|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-4.0|<0.001
71821903|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
71821904|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
71821905|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.0|<0.001
71821906|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|<0.001
71821907|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.12|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-1.0|0.12
71821908|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.019|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.019
71821909|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-2.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-2.0|<0.001
71853495|NCT01184859|143220659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
71853496|NCT01184859|143220659|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided|||||||<0.001
71853497|NCT01184859|143220660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.272||||0.194|TWO_SIDED|95.0|-0.685|-0.141||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.141|-0.685|0.194
71903836|NCT02669862|143328967|OTHER|||||||0.0236||||||Not adjusted for multiple comparisons|Chi-squared|||||||0.0236
71903837|NCT02429258|143328971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.0|STANDARD_ERROR_OF_MEAN|6.08|<|0.001||95.0|-36.1|-12.0|||Mixed Models Analysis|||||-12.0|-36.1|<0.001
71853498|NCT01184859|143220660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.547||||0.015|TWO_SIDED|95.0|-0.985|-0.108||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.108|-0.985|0.015
71853499|NCT01184859|143220660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.854|||<|0.001|TWO_SIDED|95.0|-1.317|-0.391||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.391|-1.317|<0.001
71853500|NCT01184859|143220660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.888||||0.001|TWO_SIDED|95.0|-1.426|-0.351||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.||||-0.351|-1.426|0.001
71853501|NCT01537120|143220693|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.91|||||TWO_SIDED|90.0|0.85|0.96||||||||0.96|0.85|
71853502|NCT01537120|143220694|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|||||TWO_SIDED|90.0|-0.36|-0.23||||||||-0.23|-0.36|
71853503|NCT01537120|143220695|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46|||||TWO_SIDED|90.0|-0.62|-0.3||||||||-0.30|-0.62|
71903838|NCT02429258|143328972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.8||0.01||95.0|-26.8|-3.8|||ANCOVA|||||-3.8|-26.8|0.010
71903839|NCT02429258|143328973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.42||0.023||95.0|0.1|1.8|||ANCOVA|||||1.8|0.1|0.023
71903840|NCT02429258|143328974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.001||95.0|7.7|22.2|||ANCOVA|||||22.2|7.7|<0.001
71903841|NCT02429258|143328975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|3.72|<|0.001||95.0|-23.5|-8.7|||ANCOVA|||||-8.7|-23.5|<0.001
71903842|NCT02429258|143328976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.7|STANDARD_ERROR_OF_MEAN|8.47|<|0.001||95.0|-46.6|-12.9|||ANCOVA|||||-12.9|-46.6|<0.001
71821910|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3||0.032|TWO_SIDED|95.0|-1.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-1.0|0.032
71903843|NCT02429258|143328977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|9.14|<|0.001||95.0|-59.0|-22.7|||ANCOVA|||||-22.7|-59.0|<0.001
71903844|NCT02429258|143328978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.1||0.024||95.0|-0.43|-0.03|||ANCOVA|||||-0.03|-0.43|0.024
71903845|NCT02429258|143328979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|STANDARD_ERROR_OF_MEAN|4.55||0.019||95.0|-19.9|-1.8|||ANCOVA|||||-1.8|-19.9|0.019
71903846|NCT02429258|143328980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.3|STANDARD_ERROR_OF_MEAN|9.25|<|0.001||95.0|-54.7|-17.9|||ANCOVA|||||-17.9|-54.7|<0.001
71903847|NCT02429258|143328981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|2.86||0.017||95.0|1.3|12.7|||ANCOVA|||||12.7|1.3|0.017
71680378|NCT02135107|142878777|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||||||<0.001
71821911|NCT02886728|143145992|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-2.0|<0.001
71821912|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
71821913|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
71903848|NCT02397694|143328982|NON_INFERIORITY|Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%|Difference in percentages|2.9||||0.5|TWO_SIDED|95.0|-8.5|14.2|||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs \> 100,000 copies/mL).||||14.2|-8.5|0.5
71903849|NCT02320695|143329065|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.12||0.187|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.05|-0.33|0.187
71903850|NCT02320695|143329065|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.101|TWO_SIDED|95.0|-0.42|0.04|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.04|-0.42|0.101
71903851|NCT02320695|143329065|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.49|-0.1|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.10|-0.49|0.002
71921878|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-13.0|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||16.2|-13.0|
71821914|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-10.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-10.0|<0.001
71821915|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-15.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-15.0|<0.001
71903852|NCT02320695|143329065|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.53|-0.12|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.12|-0.53|<0.001
71821916|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.8||0.001|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.001
71853504|NCT02123797|143220739|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0007|TWO_SIDED|95.0|1.35|3.06||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive stage confirmation (numerator=108/70) to Serial Care patients with and without invasive stage confirmation (denominator=168/180) after adjustment for matched study.|||3.06|1.35|0.0007
71853505|NCT02123797|143220740|SUPERIORITY||Odds Ratio (OR)|1.87||||0.0022|TWO_SIDED|95.0|1.25|2.8||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive mediastinal staging (numerator=91/87) to Serial Care patients with and without mediastinal invasive staging (denominator=126/222) after adjustment for matched study.|||2.80|1.25|0.0022
71853506|NCT02123797|143220741|SUPERIORITY||Odds Ratio (OR)|3.12||||0.0004|TWO_SIDED|95.0|1.67|5.85||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients with and without bi-modal staging (denominator=267/81) after adjustment for matched study design.|||5.85|1.67|0.0004
71903853|NCT02320695|143329066|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.12||0.023|TWO_SIDED|95.0|-0.54|-0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.05|-0.54|0.023
71680379|NCT02135107|142878778|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at a two-sided significance level of alpha = 0.05.||Comparison at Week 12||||<0.001
71680380|NCT02135107|142878778|SUPERIORITY||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||Comparison at Week 24||||<0.001
71680381|NCT02135107|142878779|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.23|0.49|||Log Rank|||||0.49|0.23|<0.001
71903854|NCT02320695|143329066|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.12||0.522|TWO_SIDED|95.0|-0.32|0.2|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||0.20|-0.32|0.522
71680382|NCT02135107|142878780|SUPERIORITY||Group difference|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||-6.8|-23.5|<0.001
71680383|NCT02135107|142878783|SUPERIORITY||Group difference|0.0|||=|0.992|TWO_SIDED|95.0|-3.5|3.5||P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Chi-squared||Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.|||3.5|-3.5|=0.992
71680384|NCT00474045|142878786|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.074||0.4||95.0|-0.21|0.08||P-value for superiority was calculated.|Regression, Linear|Treatment, country, pregnancy (preg.) status at randomisation (random.)-fixed. HbA1c at rand.(covariate) \& at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% confidence interval (CI) was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.08|-0.21|0.400
71680385|NCT00474045|142878787|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.096||0.122||95.0|-0.34|0.04||P-value for superiority was calculated|Regression, Linear|Treatment, country, preg. status at rand.(fixed factors),HbA1c at rand.(covariate),HbA1c at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% CI was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.||0.04|-0.34|0.122
71680386|NCT02278120|142878889|SUPERIORITY||Hazard Ratio, log|0.553|||<|1e-07|TWO_SIDED|95.0|0.441|0.694|||Log Rank|||||0.694|0.441|<0.0000001
71821917|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
71821918|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
71921879|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|6.5|||TWO_SIDED|95.0|-12.9|14.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 1 hour||14.2|-12.9|
71921880|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-16.4|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.1|-16.4|
71921881|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-13.9|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2 postdose PM 4 hour||7.9|-13.9|
71680387|NCT02278120|142878890|SUPERIORITY||Cox Proportional Hazard|0.712||||0.00973|TWO_SIDED|95.0|0.535|0.948||One-sided stratified log-rank test|Log Rank|||||0.948|0.535|0.00973
71680388|NCT02278120|142878891|SUPERIORITY|||||||0.00098|||||||Cochran-Mantel-Haenszel|||||||0.000980
71680389|NCT02278120|142878892|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.002
71921882|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-15.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||6.4|-15.8|
71903855|NCT02320695|143329066|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.67|-0.16|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.16|-0.67|<0.001
71903856|NCT02320695|143329066|NON_INFERIORITY_OR_EQUIVALENCE|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 \< D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.34|STANDARD_ERROR_OF_MEAN|0.12||0.013|TWO_SIDED|95.0|-0.63|-0.07|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.||||-0.07|-0.63|0.013
71903857|NCT01670656|143329069|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-1.0|-0.2|||cLDA|||||-0.2|-1.0|< 0.001
71903858|NCT01670656|143329069|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
71903859|NCT01670656|143329069|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||cLDA|||||-0.4|-1.1|< 0.001
71903860|NCT01670656|143329069|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.5|||<|0.001|TWO_SIDED|95.0|-0.9|-0.2|||cLDA|||||-0.2|-0.9|< 0.001
71903861|NCT01670656|143329070|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.7|||=|0.002|TWO_SIDED|95.0|-3.0|-0.4|||cLDA|||||-0.4|-3.0|= 0.002
71903862|NCT01670656|143329070|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.9|||<|0.001|TWO_SIDED|95.0|-3.1|-0.6|||cLDA|||||-0.6|-3.1|< 0.001
71903863|NCT01670656|143329070|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.003|TWO_SIDED|95.0|-2.9|-0.3|||cLDA|||||-0.3|-2.9|= 0.003
71903864|NCT01670656|143329070|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.2|||=|0.024|TWO_SIDED|95.0|-2.5|0.1|||cLDA|||||0.1|-2.5|= 0.024
71903865|NCT01670656|143329071|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.6|||=|0.026|TWO_SIDED|95.0|-3.4|0.2|||cLDA|||||0.2|-3.4|= 0.026
71903866|NCT01670656|143329071|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-1.5|||=|0.036|TWO_SIDED|95.0|-3.3|0.2|||cLDA|||||0.2|-3.3|= 0.036
71903867|NCT01670656|143329071|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-2.3|||=|0.002|TWO_SIDED|95.0|-4.1|-0.5|||cLDA|||||-0.5|-4.1|= 0.002
71903868|NCT01670656|143329071|SUPERIORITY_OR_OTHER_LEGACY||Diffference in Least Squares Means|-1.2|||=|0.1|TWO_SIDED|95.0|-3.0|0.6|||cLDA|||||0.6|-3.0|= 0.1
71903869|NCT01670656|143329072|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.1|||=|0.447|TWO_SIDED|95.0|-0.6|0.3|||cLDA|||||0.3|-0.6|= 0.447
71903870|NCT01670656|143329072|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
71903871|NCT01670656|143329072|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.6|||=|0.003|TWO_SIDED|95.0|-1.0|-0.1|||cLDA|||||-0.1|-1.0|= 0.003
71903872|NCT01670656|143329072|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares Means|-0.3|||=|0.156|TWO_SIDED|95.0|-0.7|0.2|||cLDA|||||0.2|-0.7|= 0.156
71903873|NCT01640925|143329108|NON_INFERIORITY_OR_EQUIVALENCE|The number of patients needed to achieve 80% power was estimated at 171 using Cox proportional hazards regression (hazard ratio reduction of 0.66; 0.15 probability of infection with control) using a two-sided 5% significance.|Cox Proportional Hazard|0.555||||0.049|TWO_SIDED|95.0|0.309|0.998|||Regression, Cox||Hypothesis: Compared to soap and water daily bathing, 2% chlorhexidine gluconate bathing on ICU admission and every 48 hours during surgical ICU care will decrease the risk of acquiring four hospital-acquired infections in surgical ICU patients.|||0.998|0.309|0.049
71921883|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-16.0|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 predose AM||4.5|-16.0|
71921884|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-13.6|13.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||13.1|-13.6|
71921885|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|95.0|-15.2|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3 postdose PM 4 hour||9.6|-15.2|
71921886|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-15.5|3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||3.0|-15.5|
71921887|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|4.1|||TWO_SIDED|95.0|-16.6|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4 predose AM||0.5|-16.6|
71921888|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-11.8|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||8.4|-11.8|
71921889|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-10.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-19.4|-0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5 predose AM||-0.7|-19.4|
71680390|NCT02266472|142878901|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|99.11|STANDARD_DEVIATION|6.3|<|0.0001|TWO_SIDED|90.0|96.4|101.89|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.89|96.40|<0.0001
71853507|NCT02123797|143220742|SUPERIORITY||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.5|3.36||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients with and without tri-modal staging (denominator=132/216) after adjustment for matched study design.|||3.36|1.50|<0.0001
71853508|NCT02123797|143220743|SUPERIORITY||Odds Ratio (OR)|2.58||||0.0366|TWO_SIDED|95.0|1.665|3.996||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without invasive staging (numerator=108/70) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||3.996|1.665|0.0366
71853509|NCT02123797|143220743|SUPERIORITY||Odds Ratio (OR)|2.621||||0.0779|TWO_SIDED|95.0|1.473|4.665||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without invasive staging (numerator=46/30) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design.|||4.665|1.473|0.0779
71853510|NCT02123797|143220744|SUPERIORITY||Odds Ratio (OR)|2.358||||0.0703|TWO_SIDED|95.0|1.536|3.621||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without mediastinal staging (numerator=91/87) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||3.621|1.536|0.0703
71853511|NCT02123797|143220744|SUPERIORITY||Odds Ratio (OR)|2.535||||0.0631|TWO_SIDED|95.0|1.446|4.444||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without mediastinal staging (numerator=40/36) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study.|||4.444|1.446|0.0631
71853512|NCT02123797|143220745|SUPERIORITY||Odds Ratio (OR)|3.191||||0.001|TWO_SIDED|95.0|1.671|6.093||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without bi-modal staging (numerator=161/17) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||6.093|1.671|0.0010
71853513|NCT02123797|143220745|SUPERIORITY||Odds Ratio (OR)|1.103||||0.1972|TWO_SIDED|95.0|0.526|2.314||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without bi-modal staging (numerator=62/14) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study.|||2.314|0.526|0.1972
71853514|NCT02123797|143220746|SUPERIORITY||Odds Ratio (OR)|2.739||||0.0055|TWO_SIDED|95.0|1.785|4.203|||Regression, Logistic||Odds ratio comparing Multidisciplinary Clinic patients with and without tri-modal staging (numerator=99/79) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||4.203|1.785|0.0055
71853515|NCT02123797|143220746|SUPERIORITY||Odds Ratio (OR)|2.242||||0.2572|TWO_SIDED|95.0|1.287|3.905||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing Serial Care patients in conference with and without tri-modal staging (numerator=39/37) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study.|||3.905|1.287|0.2572
71853516|NCT02123797|143220747|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0045|TWO_SIDED|95.0|1.24|3.25||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients with and without stage appropriate treatment (denominator=232/106) after adjustment for matched study.|||3.25|1.24|0.0045
71853517|NCT02123797|143220748|SUPERIORITY||Odds Ratio (OR)|2.249||||0.0474|TWO_SIDED|95.0|1.368|3.699||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without stage appropriate treatment (numerator=140/33) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|We examined treatment selection practices with or without MD care in a single healthcare system.||3.699|1.368|0.0474
71853518|NCT02123797|143220748|SUPERIORITY||Odds Ratio (OR)|1.751||||0.6353|TWO_SIDED|95.0|0.91|3.37||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing SC patients in conference with and without stage appropriate treatment (numerator=58/15) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study.|||3.370|0.910|0.6353
71853519|NCT02123797|143220750|SUPERIORITY||Odds Ratio (OR)|2.955||||0.0014|TWO_SIDED|95.0|1.52|5.747||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=140/37) to SC conference patients with and without concordance to recommendations (denominator=45/30) after adjustment for matched study design.|||5.747|1.520|0.0014
71680391|NCT02266472|142878902|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints,using an acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|101.25|STANDARD_DEVIATION|10.7|<|0.0001|TWO_SIDED|90.0|96.54|106.19|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.19|96.54|<0.0001
71903874|NCT00442013|143329119|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.086||0.12|TWO_SIDED|95.0|0.0|0.3|||Regression, Linear|Linear mixed effects model is robust to data that are missing at random that has characteristics similar to multiple imputation techniques.||All participants included in the analysis. The model includes the data (ACQ scores) from all time points including baseline. The treatment effect (delta-delta) comparing the difference from baseline at 6 months is estimated from the model. Longitudinal models estimated the change from baseline to 6 months in a measurement using generalized estimating equations with an unstructured or exchangeable covariance matrix to adjust for repeated measures.||0.3|0.0|0.12
71903875|NCT00442013|143329120|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2593||0.65|TWO_SIDED|95.0|-0.3|0.2|||Regression, Linear|||||0.2|-0.3|0.65
71821919|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.0||0.009|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.009
71821920|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.0||0.003|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.003
71821921|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
71821922|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.11|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.11
71821923|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.066|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-8.0|0.066
71903876|NCT00442013|143329121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0906||0.99|TWO_SIDED|95.0|-0.1|0.1|||Regression, Linear|||||0.1|-0.1|0.99
71903877|NCT00442013|143329122|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.3|TWO_SIDED|95.0|0.9|1.7|||negative binomial|||||1.7|0.9|0.30
71903878|NCT00442013|143329123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.14|TWO_SIDED|95.0|-0.07|0.01|||Regression, Linear|Model includes the data from all time points. Treatment effect (delta-delta) comparing the difference from baseline at 24 weeks is from the model.||||0.01|-0.07|0.14
71903879|NCT00442013|143329124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.2|TWO_SIDED|95.0|-2.1|0.4|||Regression, Linear|||||0.4|-2.1|0.20
71903880|NCT01332019|143329142|SUPERIORITY_OR_OTHER||rate ratio|0.755||||0.0203|TWO_SIDED|95.0|0.595|0.957||q2w/q4w|negative binomial regression|||Based on negative binomial regression for each treatment group, with adjustment for EDSS (\<4 vs. \>=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (\<40 vs. \>=40) at 105MS302 baseline.||0.957|0.595|0.0203
71903881|NCT01332019|143329143|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0201|TWO_SIDED|95.0|0.59|0.96||Based on Cox proportion hazards model, adjusted for EDSS (\<4 vs \>= 4), age (\<40 vs \>=40), relapse rate (based on one year before 105MS301 and 105MS301), and gadolinium (Gd) enhancing lesions (presence vs. absence) at 105MS302 baseline.|Cox proportion hazards model|||q2w/q4w||0.96|0.59|0.0201
71903882|NCT01332019|143329144|SUPERIORITY_OR_OTHER||lesion mean ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.41|0.63||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of T2 lesions.|negative binomial regression|||Week 48||0.63|0.41|<0.0001
71903883|NCT01332019|143329144|SUPERIORITY_OR_OTHER||lesion mean ratio|0.49|||<|0.0001|TWO_SIDED|95.0|0.39|0.62||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 302 baseline number of T2 lesions.|negative binomial regression|||Week 96||0.62|0.39|<0.0001
71903884|NCT01332019|143329145|SUPERIORITY_OR_OTHER||lesion mean ratio|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 48||0.68|0.43|<0.0001
71903885|NCT01332019|143329145|SUPERIORITY_OR_OTHER||lesion mean ratio|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.71||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 96||0.71|0.43|<0.0001
71903886|NCT01332019|143329146|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 48||||<0.0001
71903887|NCT01332019|143329146|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 96||||<0.0001
71903888|NCT01332019|143329147|SUPERIORITY_OR_OTHER|||||||0.0012||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 48||||0.0012
71903889|NCT01332019|143329147|SUPERIORITY_OR_OTHER|||||||0.0026||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 96||||0.0026
71903890|NCT01332019|143329153|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.57||||0.006|TWO_SIDED|95.0|0.38|0.85||Based on Cox Proportional Hazards model, adjusted for 105MS302 baseline EDSS and age (\<40 vs \>=40).|Cox Proportional Hazards model||q2w/q4w|||0.85|0.38|0.0060
71903891|NCT00980785|143329176|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-22.5|STANDARD_DEVIATION|78.7||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
71903892|NCT00980785|143329176|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-31.71|STANDARD_DEVIATION|90.6||0.836|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.836
71903893|NCT00980785|143329177|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.1|STANDARD_DEVIATION|0.21||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
71903894|NCT00980785|143329177|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.63|STANDARD_DEVIATION|0.32||0.009|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.009
71903895|NCT00980785|143329178|OTHER|Mann-Whitney Test|Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|1.56||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
71903896|NCT00980785|143329178|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-0.29|STANDARD_DEVIATION|1.23||0.755|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.755
71903897|NCT00980785|143329179|OTHER|Mann-Whitney test|Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|8.9||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
71680392|NCT02266472|142878903|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|99.12|STANDARD_DEVIATION|12.9|<|0.0001|TWO_SIDED|90.0|93.69|104.87|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||104.87|93.69|<0.0001
71821924|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
71821925|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.4|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.40
71821926|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.24|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.24
71821927|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
71853520|NCT02123797|143220751|SUPERIORITY||Odds Ratio (OR)|3.093||||0.0019|TWO_SIDED|95.0|1.519|6.299||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=145/32) to SC conference patients with and without concordance to recommendations (denominator=49/26) after adjustment for matched study design.|||6.299|1.519|0.0019
71853521|NCT02123797|143220752|SUPERIORITY||Odds Ratio (OR)|40.892||||0.0499|TWO_SIDED|95.0|1.002|999.999||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=174/3) to SC conference patients with and without concordance to recommendations (denominator=71/4) after adjustment for matched study design.|||999.999|1.002|0.0499
71853522|NCT02123797|143220753|SUPERIORITY||Odds Ratio (OR)|2.663||||0.0263|TWO_SIDED|95.0|1.123|6.319||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=158/19) to SC conference patients with and without concordance to recommendations (denominator=60/15) after adjustment for matched study design.|||6.319|1.123|0.0263
71853523|NCT02123797|143220754|SUPERIORITY||Odds Ratio (OR)|2.566||||0.1503|TWO_SIDED|95.0|0.711|9.269||Conditional logistic regression adjusted for the matched study design, sex, age, and histology.|Regression, Logistic||Odds ratio comparing MD patients with and without concordance to recommendations (numerator=87/14) to SC conference patients with and without concordance to recommendations (denominator=38/8) after adjustment for matched study design.|||9.269|0.711|0.1503
71853524|NCT02123797|143220767|SUPERIORITY|||||||0.0042|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0042
71853525|NCT02123797|143220767|SUPERIORITY|||||||0.0805|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.0805
71853526|NCT02123797|143220767|SUPERIORITY|||||||0.0073|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0073
71853527|NCT02123797|143220767|SUPERIORITY|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0579
71853528|NCT02123797|143220768|SUPERIORITY|||||||0.0146|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Diagnostic Biopsy||||0.0146
71853529|NCT02123797|143220768|SUPERIORITY|||||||0.16|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Non-invasive Staging Test||||0.16
71853530|NCT02123797|143220768|SUPERIORITY|||||||0.0014|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Invasive Staging Test||||0.0014
71853531|NCT02123797|143220768|SUPERIORITY|||||||0.0037|||||||Kruskal-Wallis|||Time from Initial Detection of Lesion to Definitive Treatment||||0.0037
71853532|NCT02123797|143220775|SUPERIORITY|||||||0.7506|||||||Log Rank|||||||0.7506
71853533|NCT02123797|143220775|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.54|TWO_SIDED|95.0|0.85|1.36|||Regression, Cox||Comparison is Multidisciplinary/Serial Care.|||1.36|0.85|0.54
71853534|NCT02123797|143220776|SUPERIORITY|||||||0.4847|||||||Log Rank|||||||0.4847
71853535|NCT02123797|143220776|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.87|1.43|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.43|0.87|0.51
71903898|NCT00980785|143329179|OTHER|Mann-Whitney test|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|2.2||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.491
71821928|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.1||0.17|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.17
71821929|NCT02886728|143145993|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.008|TWO_SIDED|95.0|-10.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-10.0|0.008
71821930|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-12.0|<0.001
71853536|NCT02123797|143220776|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.51|TWO_SIDED|95.0|0.84|1.67|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.67|0.84|0.51
71853537|NCT02123797|143220777|SUPERIORITY|||||||0.9874|||||||Log Rank|||||||0.9874
71853538|NCT02123797|143220777|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8|TWO_SIDED|95.0|0.82|1.29|||Regression, Cox||Comparison is Multidisciplinary/Serial Care|||1.29|0.82|0.80
71853539|NCT02123797|143220778|SUPERIORITY|||||||0.5377|||||||Log Rank|||||||0.5377
71853540|NCT02123797|143220778|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.83|1.34|||Regression, Cox||Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference|||1.34|0.83|0.73
71853541|NCT02123797|143220778|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.73|TWO_SIDED|95.0|0.82|1.57|||Regression, Cox||Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference|||1.57|0.82|0.73
71853542|NCT00443755|143220779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71853543|NCT00443755|143220780|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71853544|NCT00443755|143220781|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
71853545|NCT00443755|143220782|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71853546|NCT00443755|143220783|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in triglyceride levels.||||0.03
71853547|NCT00443755|143220783|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in HDL-C levels.||||0.06
71853548|NCT00443755|143220783|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of mean change in non-HDL-C levels.||||0.06
71853549|NCT00443755|143220784|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.23
71853550|NCT00443755|143220785|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71853551|NCT00443755|143220786|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.13
71853552|NCT00443755|143220787|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71853553|NCT00443755|143220788|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
71853554|NCT00443755|143220789|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71853555|NCT00443755|143220790|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.006
71853556|NCT00443755|143220791|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.18
71853557|NCT00443755|143220792|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
71853558|NCT00376935|143220838|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-9.0||||0.1996|ONE_SIDED|98.4||14.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.||14||0.1996
71903899|NCT05142332|143329184|SUPERIORITY||Adjusted absolute difference|11.9|||<|0.001|TWO_SIDED|95.0|4.5|19.3|||Regression, Logistic|||||19.3|4.5|<0.001
71903900|NCT05142332|143329185|SUPERIORITY||Adjusted absolute difference|7.9|||<|0.001|TWO_SIDED|95.0|1.7|14.1|||Regression, Logistic|||||14.1|1.7|<0.001
71903901|NCT01358877|143329212|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0446|TWO_SIDED|95.0|0.66|1.0||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.00|0.66|0.0446
71903902|NCT01358877|143329214|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.043|TWO_SIDED|95.0|0.68|0.99||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.68|0.0430
71903903|NCT01358877|143329216|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0327|TWO_SIDED|95.0|0.67|0.98||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.98|0.67|0.0327
71903904|NCT01358877|143329218|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4673|TWO_SIDED|95.0|0.66|1.21||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.21|0.66|0.4673
71903905|NCT01358877|143329220|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.63|0.99|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||0.99|0.63|0.0430
71903906|NCT01358877|143329222|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.64|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.||1.04|0.64|0.1007
71903907|NCT01358877|143329224|SUPERIORITY||Treatment Difference|0.4|||||TWO_SIDED|95.0|0.0|0.8|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.|||0.8|0.0|
71903908|NCT01358877|143329225|SUPERIORITY||Treatment Difference|-0.1|||||TWO_SIDED|95.0|-1.0|0.9|||||95% CI was estimated using Hauck-Anderson correction.|||0.9|-1.0|
71903909|NCT01358877|143329226|SUPERIORITY||Treatment Difference|0.1|||||TWO_SIDED|95.0|-0.3|0.5|||||95% CI was estimated using Hauck-Anderson correction.|||0.5|-0.3|
71903910|NCT03575884|143329257|SUPERIORITY||Study_arm timepoint interactions|-27.32|||<|0.05|TWO_SIDED|95.0|-52.49|-2.14|||Mixed Models Analysis|||||-2.14|-52.49|<0.05
71903911|NCT04322994|143329283|OTHER|||||||0.18||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with any desaturation event.||||0.18
71903912|NCT04322994|143329283|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.||||0.26
71903913|NCT04322994|143329284|OTHER|||||||0.26||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.26
71903914|NCT04322994|143329284|OTHER|||||||0.08||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.||||0.08
71903915|NCT04322994|143329285|OTHER|||||||0.28|||||||Chi-squared|||Analysis of between-group difference for participants with any qualifying event.||||0.28
71903916|NCT04322994|143329285|OTHER|||||||0.38||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.||||0.38
71903917|NCT04322994|143329286|OTHER|||||||0.88||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Analysis of between-group difference for participants with at any qualifying desaturation event.||||0.88
71903918|NCT04322994|143329287|OTHER|||||||0.14||||||The a priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-squared test of independence||Analysis of between-group difference for participants with any surgical interruption.||||0.14
71903919|NCT04322994|143329287|OTHER|||||||0.21||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|Chi-squared test of independence||Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.||||0.21
71903920|NCT02403830|143329294|SUPERIORITY||Mean Difference (Final Values)|-32.0||||0.261|TWO_SIDED|95.0|-90.0|25.0|||Mixed Models Analysis|||||25|-90|0.261
71903921|NCT01980706|143329297|SUPERIORITY||Mean Difference (Net)|4.16||||0.018|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.018
71903922|NCT01980706|143329298|SUPERIORITY||Mean Difference (Net)|3.68||||0.028|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.028
71903923|NCT01980706|143329299|SUPERIORITY||Mean Difference (Net)|0.65||||0.52|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.52
71903924|NCT01980706|143329300|SUPERIORITY||Mean Difference (Net)|0.84||||0.43|TWO_SIDED|||||Threshold for significance is \<.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.|||||0.43
71903925|NCT01980706|143329301|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6|TWO_SIDED|||||Threshold for significance is \<.05|ANCOVA|Adjusted for baseline|Estimated parameter is the overall treatment main effect F statistic from the fitted ANCOVA model assessing the null hypothesis of equal values across the three groups|||||0.60
71903926|NCT01980706|143329302|SUPERIORITY||Table probability for Fisher's Exact|0.002||||0.07|TWO_SIDED|||||Threshold for significance is \<.05|Fisher Exact|||||||0.07
71903927|NCT02196038|143329328|SUPERIORITY||Mean Difference (Final Values)|1.5|||<|0.0001|TWO_SIDED|95.0|0.9|2.0|||joint model|Joint model of ANCOVA plus survival||||2.0|0.9|<0.0001
71903928|NCT02196038|143329329|SUPERIORITY||Rate Ratio|0.93||||0.59|TWO_SIDED|95.0|0.66|1.19|||Joint Model|Joint model of Poisson regression and survival||||1.19|0.66|0.59
71903929|NCT04436822|143329388|SUPERIORITY||Intercept from ANCOVA as agreement rate|88.9|||<|0.05|TWO_SIDED|90.0|87.1|90.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||90.7|87.1|<0.05
71903930|NCT04436822|143329388|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.5|||<|0.05|TWO_SIDED|90.0|85.4|89.7|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.7|85.4|<0.05
71903931|NCT04436822|143329388|SUPERIORITY||Intercept from ANCOVA as agreement rate|87.9|||<|0.05|TWO_SIDED|90.0|85.8|89.9|||ANCOVA|A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).||||89.9|85.8|<0.05
71903932|NCT00369668|143329394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.0|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|22.5|37.4|||Mixed Models Analysis|Greenhouse-Geisser degrees of freedom adjustment was not necessary.||Group by Test Session ANOVA with repeated measures on second factor.||37.4|22.5|<0.05
71903933|NCT03534063|143329444|SUPERIORITY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|Comparisons for opioid consumption and composite pain intensity were performed by analysis of covariance, adjusting for baseline differences in groups||||||.047
71903934|NCT03534063|143329445|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||.638
71903935|NCT00789191|143329478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.001||95.0|-0.77|-0.33||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|Analysis of covariance (ANCOVA) was used; baseline HbA1c was included as covariate and treatment, stratification and country was included as factors||Null hypothesis: Difference between mean HbA1c in the two treatment arms is equal to zero. Power calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%||-0.33|-0.77|0.0010
71903936|NCT00789191|143329479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2||||0.001||95.0|1.65|6.19||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||6.19|1.65|0.0010
71903937|NCT00789191|143329480|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.47||||0.008||95.0|1.26|4.81||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||4.81|1.26|0.0080
71903938|NCT00789191|143329481|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23||||0.063||95.0|0.96|5.2||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.||5.20|0.96|0.063
71903939|NCT00789191|143329482|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.07||||0.135||95.0|0.8|5.37||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|Regression, Logistic||Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate|Null hypothesis: Odds ratio is equal to one.||5.37|0.8|0.135
71903940|NCT00789191|143329483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.121||95.0|-0.07|0.63||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||0.63|-0.07|0.121
71903941|NCT00789191|143329484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.84||||0.109||95.0|-0.19|1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||1.88|-0.19|0.109
71903942|NCT00789191|143329485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.45||||0.001||95.0|-3.01|-1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p\<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.||||-1.88|-3.01|0.0010
71903943|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.01||||||95.0|-2.5|-1.51|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast|||-1.51|-2.50|
71903944|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.64||||||95.0|-2.4|-0.89|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of breakfast|||-0.89|-2.40|
71903945|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||||95.0|-1.69|-0.35|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before lunch|||-0.35|-1.69|
71903946|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||||95.0|-2.05|-0.56|||Linear mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of lunch|||-0.56|-2.05|
71903947|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.77||||||95.0|-1.58|0.05|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before dinner|||0.05|-1.58|
71903948|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.88||||||95.0|-1.75|-0.02|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. 120 minutes after start of dinner|||-0.02|-1.75|
71903949|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||||95.0|-1.88|-0.2|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Bedtime|||-0.20|-1.88|
71903950|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||||95.0|-1.84|-0.49|||Linear Mixed Model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. At 03:00 a.m.|||-0.49|-1.84|
71903951|NCT00789191|143329489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||||95.0|-2.26|-1.34|||Linear Mixed-model|PG profile analysis:linear mixed effect model.Treatment,time,country,time-by-treatment interaction as explanatory variables.Subject as a random factor|COMB-SITA Difference. Before breakfast the following day|||-1.34|-2.26|
71903952|NCT00762372|143329517|NON_INFERIORITY|Time to extubation = treatment group + surgical site +surgery time|Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|-6.6|-2.7||||||||-2.7|-6.6|
71903953|NCT00762372|143329518|NON_INFERIORITY|"Adjusted means of time from the end of study drug inhalation to extubation in the BLM-240 N2O group and sevoflurane group, which were obtained by analysis of covariance with surgical site and surgery time as covariates, were used to verify the non-inferiority of BLM-240 to the comparator sevoflurane, with a delta = 1.0 (minute) and significance level alpha = 2.5% (one-sided)."||||||0.15|||||||t-test, 2 sided|||||||0.1500
71903954|NCT00762372|143329519|NON_INFERIORITY|Two-sample t-test||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71903955|NCT00762372|143329523|NON_INFERIORITY|Fisher's exact test||||||0.3113|||||||Fisher Exact|||||||0.3113
71903956|NCT00762372|143329525|NON_INFERIORITY|Fisher's exact test||||||1|||||||Fisher Exact|||||||1.0000
71903957|NCT03364335|143329529|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5461|||||||ANCOVA|||||||0.5461
71903958|NCT03364335|143329529|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0364|||||||ANCOVA|||||||0.0364
71903959|NCT03364335|143329529|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0156|||||||ANCOVA|||||||0.0156
71903960|NCT03364335|143329529|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0349|||||||ANCOVA|||||||0.0349
71903961|NCT03364335|143329530|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5348|||||||ANCOVA|||||||0.5348
71903962|NCT03364335|143329530|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0379|||||||ANCOVA|||||||0.0379
71903963|NCT03364335|143329530|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0215|||||||ANCOVA|||||||0.0215
71903964|NCT03364335|143329530|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0464|||||||ANCOVA|||||||0.0464
71903965|NCT03364335|143329531|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||1|||||||Chi-squared|||||||1.0000
71903966|NCT03364335|143329531|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.2646|||||||Chi-squared|||||||0.2646
71903967|NCT03364335|143329531|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.0749|||||||Chi-squared|||||||0.0749
71903968|NCT03364335|143329531|OTHER|Pearson's Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.6758|||||||Chi-squared|||||||0.6758
71903969|NCT03364335|143329532|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.9656|||||||ANCOVA|||||||0.9656
71903970|NCT03364335|143329532|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.4254|||||||ANCOVA|||||||0.4254
71903971|NCT03364335|143329532|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.1276|||||||ANCOVA|||||||0.1276
71903972|NCT03364335|143329532|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.5937|||||||ANCOVA|||||||0.5937
71903973|NCT03364335|143329533|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.601|||||||ANCOVA|||||||0.6010
71903974|NCT03364335|143329533|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6513|||||||ANCOVA|||||||0.6513
71903975|NCT03364335|143329533|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4354|||||||ANCOVA|||||||0.4354
71903976|NCT03364335|143329533|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.031|||||||ANCOVA|||||||0.0310
71680393|NCT02266472|142878904|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|108.58|STANDARD_DEVIATION|9.3|<|0.0001|TWO_SIDED|90.0|104.17|113.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||113.17|104.17|<0.0001
71680394|NCT02266472|142878905|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|98.89|STANDARD_DEVIATION|6.3|||TWO_SIDED|90.0|96.18|101.67|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||101.67|96.18|
71680395|NCT02266472|142878906|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|101.37|STANDARD_DEVIATION|11.0|||TWO_SIDED|90.0|96.53|106.45|||ANOVA|ANOVA model on the logarithmic scale including random effects for 'subjects within sequences' \& fixed effect for 'sequence', 'period' \& 'treatment'.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).|||106.45|96.53|
71680396|NCT00808639|142878907|SUPERIORITY_OR_OTHER||Pathologic response rate|49.0|||||TWO_SIDED|80.0|38.0|61.0||||||This study used a Simon's optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.||61|38|
71680397|NCT01187498|142878911|NON_INFERIORITY_OR_EQUIVALENCE|A power analysis indicated that a sample size of 70 per group would provide 80% power with a one-sided alpha of 0.05 to declare two means equivalent, assuming a mean voiding frequency of 8.2 for behavioral treatment, a mean voiding frequency of 8.0 for drug therapy, and a standard deviation of 2.3 for both groups. Equivalence was defined as ±15% of the drug therapy posttreatment mean.|Difference of the Means|0.4|STANDARD_ERROR_OF_MEAN|0.346||0.001||95.0|||||Regression, Linear||The estimated parameter of dispersion is the standard error of the regression coefficient which measured the adjusted difference of the group means.|The primary analysis was an equivalence analysis to compare the two treatment groups on posttreatment 24- hour voiding frequency using a margin of ±15% of the drug group mean. Schuirmann's two one-sided tests (TOST) approach was used first to examine completers and then repeated using last observation carried forward to include participants who did not complete therapy. Adjusting the test to regression, the analyses were repeated using baseline voiding frequency as a covariate.||||.001
71680398|NCT01187498|142878912|SUPERIORITY_OR_OTHER||Difference of the Means|-0.38|STANDARD_ERROR_OF_MEAN|0.188||0.05||95.0|||||Regression, Linear||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
71680399|NCT01187498|142878913|SUPERIORITY_OR_OTHER||Difference of Group Means|0.19|STANDARD_ERROR_OF_MEAN|0.091||0.05||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.05
71903977|NCT03364335|143329534|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4644|||||||ANCOVA|||||||0.4644
71680400|NCT01187498|142878914|SUPERIORITY_OR_OTHER||Difference in Group Means|-0.14|STANDARD_ERROR_OF_MEAN|0.091||0.33||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.33
71680401|NCT01187498|142878915|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.924||0.84||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values||||.84
71680402|NCT01187498|142878916|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|-0.0563|STANDARD_ERROR_OF_MEAN|0.1249||0.69||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.69
71680403|NCT01187498|142878917|SUPERIORITY_OR_OTHER||Difference between Group Weighted Means|-0.1563|STANDARD_ERROR_OF_MEAN|0.1009||0.16||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.16
71903978|NCT03364335|143329534|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8573|||||||ANCOVA|||||||0.8573
71903979|NCT03364335|143329534|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8167|||||||ANCOVA|||||||0.8167
71903980|NCT03364335|143329534|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.9223|||||||ANCOVA|||||||0.9223
71903981|NCT03364335|143329535|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6574|||||||ANCOVA|||||||0.6574
71903982|NCT03364335|143329535|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8971|||||||ANCOVA|||||||0.8971
71680404|NCT01187498|142878918|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.1079|STANDARD_ERROR_OF_MEAN|0.1625||0.56||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.56
71680405|NCT01187498|142878919|SUPERIORITY_OR_OTHER||Difference in Weighted Group Means|0.054|STANDARD_ERROR_OF_MEAN|0.1265||0.65||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.65
71680406|NCT01187498|142878920|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Cochran-Mantel-Haenszel|||Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.||||.01
71680407|NCT01187498|142878921|SUPERIORITY_OR_OTHER||Difference in Group Proportions|-0.21|STANDARD_ERROR_OF_MEAN|0.086||0.02||95.0|||||Chi-squared||The estimated parameter of dispersion represents the standard error for the difference of the group proportions.|Cochran Mantel-Haenszel procedure.||||.02
71680408|NCT00191282|142878922|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.866||95.0|||||Log Rank|||To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: \>=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of \>=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.||||0.866
71680409|NCT00191282|142878923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.715||95.0|||||Log Rank|||||||0.715
71680410|NCT00191282|142878924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.914||95.0|||||Log Rank|||||||0.914
71680411|NCT00191282|142878925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.706||95.0|||||Log Rank|||||||0.706
71680412|NCT00191282|142878926|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.982||95.0|||||Log Rank|||||||0.982
71680413|NCT00191282|142878927|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.816||95.0|||||Log Rank|||||||0.816
71680414|NCT00191282|142878928|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.948||95.0|||||Log Rank|||||||0.948
71680415|NCT00191282|142878929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.581||95.0|||||Log Rank|||||||0.581
71821931|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
71821932|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
71903983|NCT03364335|143329535|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6317|||||||ANCOVA|||||||0.6317
71680416|NCT00191282|142878930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.647||95.0|||||Log Rank|||||||0.647
71680417|NCT00191282|142878931|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.525||95.0|||||Log Rank|||||||0.525
71680418|NCT00191282|142878932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.8||95.0|||||Log Rank|||||||0.800
71680419|NCT00191282|142878933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.662||95.0|||||Log Rank|||||||0.662
71680420|NCT00191282|142878934|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.863||95.0|||||Log Rank|||||||0.863
71680421|NCT00191282|142878935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.471||95.0|||||Log Rank|||||||0.471
71680422|NCT00191282|142878936|SUPERIORITY_OR_OTHER|||||||0.7168||95.0|||||Chi-squared|||||||0.7168
71680423|NCT00191282|142878938|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Chi-squared|||||||0.0860
71680424|NCT00191282|142878940|SUPERIORITY_OR_OTHER|||||||0.1424||95.0|||||Chi-squared|||||||0.1424
71680425|NCT00191282|142878943|SUPERIORITY_OR_OTHER|||||||0.1957||95.0|||||Chi-squared|||||||0.1957
71680426|NCT00191282|142878945|SUPERIORITY_OR_OTHER|||||||0.2434||95.0|||||Chi-squared|||||||0.2434
71680427|NCT00191282|142878947|SUPERIORITY_OR_OTHER|||||||0.2617||95.0|||||Chi-squared|||||||0.2617
71680428|NCT03055494|142878966|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|76.1|||||TWO_SIDED|95.0|63.3|88.8|||95% confidence interval|"Statistical analysis of no response of skin histology/K16 expression to treatment at Week 12"|||"A patient with missing assessment was considered as having a yes response of skin histology/K16 expression to treatment regardless of the reason for missing data (eg, premature study discontinuation, missed visit, administrative issues). However, missing baseline value was not imputed."|88.8|63.3|
71680429|NCT03055494|142878967|OTHER|Statistical hypothesis tests were not performed in this study|difference in percentages|55.8|||||TWO_SIDED|95.0|42.3|69.3|||95% confidence interval|||||69.3|42.3|
71680430|NCT05897827|142878984|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|3.93||||0.074|TWO_SIDED|95.0|3.73|4.13||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.13|3.73|0.074
71680431|NCT05897827|142878985|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 75.|Mean|75.47||||0.827|TWO_SIDED|95.0|71.12|79.83||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||79.83|71.12|0.827
71680432|NCT05897827|142878986|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.003|TWO_SIDED|95.0|3.84|4.17||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.17|3.84|0.003
71680433|NCT05897827|142878987|OTHER|We calculated the mean and 95% confidence interval using a one sample two-sided t-test against the a priori benchmark of success, which was \> 3.75.|Mean|4.01||||0.002|TWO_SIDED|95.0|3.85|4.18||Threshold for statistical significance: \<0.05|t-test, 2 sided|||||4.18|3.85|0.002
71903984|NCT03364335|143329535|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.0341|||||||ANCOVA|||||||0.0341
71903985|NCT03364335|143329536|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.372|||||||ANCOVA|||||||0.3720
71903986|NCT03364335|143329536|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.2302|||||||ANCOVA|||||||0.2302
71903987|NCT03364335|143329536|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.1377|||||||ANCOVA|||||||0.1377
71903988|NCT03364335|143329536|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4295|||||||ANCOVA|||||||0.4295
71903989|NCT03364335|143329537|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.6726|||||||ANCOVA|||||||0.6726
71903990|NCT03364335|143329537|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.7934|||||||ANCOVA|||||||0.7934
71821933|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-13.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-13.0|<0.001
71903991|NCT03364335|143329537|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.5485|||||||ANCOVA|||||||0.5485
71903992|NCT03364335|143329537|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.3676|||||||ANCOVA|||||||0.3676
71903993|NCT03364335|143329538|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1653|||||||ANCOVA|||||||0.1653
71903994|NCT03364335|143329538|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.197|||||||ANCOVA|||||||0.1970
71903995|NCT03364335|143329538|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.0608|||||||ANCOVA|||||||0.0608
71903996|NCT03364335|143329538|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1583|||||||ANCOVA|||||||0.1583
71903997|NCT03364335|143329539|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.0524|||||||ANCOVA|||||||0.0524
71903998|NCT03364335|143329539|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5221|||||||ANCOVA|||||||0.5221
71903999|NCT03364335|143329539|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3702|||||||ANCOVA|||||||0.3702
71904000|NCT03364335|143329539|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5426|||||||ANCOVA|||||||0.5426
71904001|NCT03364335|143329540|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.1843|||||||ANCOVA|||||||0.1843
71904002|NCT03364335|143329540|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.4411|||||||ANCOVA|||||||0.4411
71904003|NCT03364335|143329540|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.6991|||||||ANCOVA|||||||0.6991
71904004|NCT03364335|143329540|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3721|||||||ANCOVA|||||||0.3721
71904005|NCT03364335|143329541|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.0318|||||||ANCOVA|||||||0.0318
71904006|NCT03364335|143329541|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.3827|||||||ANCOVA|||||||0.3827
71904007|NCT03364335|143329541|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.005|||||||ANCOVA|||||||0.0050
71904008|NCT03364335|143329541|OTHER|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.1045|||||||ANCOVA|||||||0.1045
71921890|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-18.1|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||4.7|-18.1|
71904009|NCT02670915|143329542|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.|Treatment difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|<0.001
71680434|NCT05897827|142878991|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.22||||0.03|TWO_SIDED|95.0|0.03|0.42||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.42|0.03|0.03
71680435|NCT05897827|142878991|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.01||||0.95|TWO_SIDED|95.0|-0.36|0.38||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.38|-0.36|0.95
71680436|NCT05897827|142878992|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.7|||<|0.001|TWO_SIDED|95.0|0.46|0.95||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.95|0.46|<0.001
71680437|NCT05897827|142878992|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in LGBTQ+ Inclusivity, Awareness, and Advocacy, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.45||||0.01|TWO_SIDED|95.0|0.1|0.8||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.80|0.10|0.01
71680438|NCT05897827|142878992|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.26||||0.001|TWO_SIDED|95.0|0.11|0.41||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.41|0.11|0.001
71680439|NCT05897827|142878992|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Identity-Affirming Practices, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.13||||0.01|TWO_SIDED|95.0|0.03|0.24||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.24|0.03|0.01
71680440|NCT05897827|142878992|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.43||||0.001|TWO_SIDED|95.0|0.18|0.68||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.68|0.18|0.001
71680441|NCT05897827|142878992|OTHER|To test for within-arm statistical significance of the change in Self-Efficacy in Inclusivity in Restrooms and Changing Options, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44||||0.04|TWO_SIDED|95.0|0.02|0.86||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.86|0.02|0.04
71680442|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.23||||0.1|TWO_SIDED|95.0|-0.5|0.04||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.04|-0.50|0.10
71883060|NCT00385255|143285392|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, being ≥ - 10%.|Difference in percentage|1.4|||||TWO_SIDED|95.0|-0.77|3.68||||||Difference in seropositivity rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.||3.68|-0.77|
71921891|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-14.8|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6 predose AM||6.3|-14.8|
71680443|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.24||||0.14|TWO_SIDED|95.0|-0.55|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.55|0.14
71680444|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.19||||0.07|TWO_SIDED|95.0|-0.39|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.39|0.07
71680445|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.02||||0.85|TWO_SIDED|95.0|-0.18|0.22||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.22|-0.18|0.85
71680446|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.06|TWO_SIDED|95.0|-0.3|0.01||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.01|-0.30|0.06
71680447|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.07||||0.51|TWO_SIDED|95.0|-0.14|0.28||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.28|-0.14|0.51
71680448|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.33||||0.001|TWO_SIDED|95.0|0.13|0.53||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.53|0.13|0.001
71680449|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.28||||0.04|TWO_SIDED|95.0|0.01|0.55||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.55|0.01|0.04
71680450|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.06||||0.36|TWO_SIDED|95.0|-0.19|0.07||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.07|-0.19|0.36
71680451|NCT05897827|142878993|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.03||||0.62|TWO_SIDED|95.0|-0.16|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.16|0.62
71680452|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.15||||0.08|TWO_SIDED|95.0|-0.32|0.02||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.02|-0.32|0.08
71680453|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Notice the Event, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.21||||0.2|TWO_SIDED|95.0|-0.55|0.12||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.12|-0.55|0.20
71680454|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.02||||0.74|TWO_SIDED|95.0|-0.14|0.1||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.10|-0.14|0.74
71680455|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Interpret the Event as an Emergency, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.05||||0.55|TWO_SIDED|95.0|-0.12|0.23||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.23|-0.12|0.55
71680456|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.07||||0.4|TWO_SIDED|95.0|-0.22|0.09||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.09|-0.22|0.40
71821934|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
71821935|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
71680457|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Accept Responsibility for Intervening, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.12||||0.36|TWO_SIDED|95.0|-0.37|0.13||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.13|-0.37|0.36
71680458|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.39|||<|0.001|TWO_SIDED|95.0|0.18|0.6||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.60|0.18|<0.001
71821936|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-12.0|-7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-12.0|<0.001
71821937|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-9.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-9.0|<0.001
71821938|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.6||0.001|TWO_SIDED|95.0|-8.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-8.0|0.001
71821939|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
71821940|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.007|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.007
71853559|NCT00376935|143220838|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3135|ONE_SIDED|98.4||17.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.||17||0.3135
71853560|NCT00376935|143220838|SUPERIORITY_OR_OTHER_LEGACY||Shift parameter|-4.0||||0.3662|ONE_SIDED|98.4||22.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.||22||0.3662
71853561|NCT01072396|143220896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.0087||95.0|0.02|0.11||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - crossover design||0.11|0.02|0.0087
71853562|NCT01072396|143220897|SUPERIORITY_OR_OTHER||Adjusted mean ratio|1.0685||||0.067||95.0|0.9953|1.147||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||1.1470|0.9953|0.0670
71853563|NCT01072396|143220898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2059||||0.2417||95.0|-0.5527|0.1408||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design||0.1408|-0.5527|0.2417
71904010|NCT02670915|143329542|NON_INFERIORITY|Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.|Treatment difference|0.13|||<|0.001|TWO_SIDED|95.0|-0.01|0.26||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||0.26|-0.01|<0.001
71821941|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.046|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.046
71904011|NCT02670915|143329542|SUPERIORITY|Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.|Treatment difference|-0.17|||=|0.007|TWO_SIDED|95.0|-0.3|-0.03||p-values are from the 1-sided test for superiority evaluated at the 2.5% level.|multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.||-0.03|-0.30|=0.007
71904012|NCT00818207|143329622|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0007|TWO_SIDED|95.0|1.23|2.18|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.18|1.23|0.0007
71904013|NCT00818207|143329623|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0018|TWO_SIDED|95.0|1.21|2.33|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.33|1.21|0.0018
71904014|NCT00818207|143329624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.2979|TWO_SIDED|95.0|0.82|1.9||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.90|0.82|0.2979
71904015|NCT00818207|143329624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4388|TWO_SIDED|95.0|0.76|1.87||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.87|0.76|0.4388
71904016|NCT00818207|143329625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.0001|TWO_SIDED|95.0|1.35|2.2||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||2.20|1.35|<0.0001
71904017|NCT00818207|143329626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.4551|TWO_SIDED|95.0|0.81|1.62||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.||1.62|0.81|0.4551
71904018|NCT01000727|143329652|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.929|TWO_SIDED|95.02|0.91|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.91|0.929
71904019|NCT01000727|143329653|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.777|TWO_SIDED|95.02|0.9|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.09|0.90|0.777
71904020|NCT01000727|143329654|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.274|TWO_SIDED|95.0|0.76|1.08||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model|||||1.08|0.76|0.274
71904021|NCT01000727|143329655|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.631|TWO_SIDED|95.0|0.86|1.09|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.09|0.86|0.631
71904022|NCT01000727|143329656|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.354|TWO_SIDED|95.0|0.88|1.42|||Cox Proportional Hazard Regression Model||A hazard ratio \< 1 indicates a lower risk with this treatment compared to Placebo|||1.42|0.88|0.354
71904023|NCT01000727|143329657|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.161|TWO_SIDED|95.0|0.73|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.73|0.161
71904024|NCT01000727|143329658|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.36|TWO_SIDED|95.0|0.91|1.31|||Cox Proportional Hazard Regression Model|||||1.31|0.91|0.360
71680459|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Know How to Intervene, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.12||||0.41|TWO_SIDED|95.0|-0.16|0.39||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.39|-0.16|0.41
71680460|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|-0.01||||0.92|TWO_SIDED|95.0|-0.22|0.2||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.20|-0.22|0.92
71904025|NCT01000727|143329659|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.202|TWO_SIDED|95.0|0.88|1.03|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.03|0.88|0.202
71904026|NCT01000727|143329660|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.329|TWO_SIDED|95.0|0.87|1.05|||Cox Proportional Hazard Regression Model|||||1.05|0.87|0.329
71904027|NCT01000727|143329661|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.797|TWO_SIDED|95.0|0.9|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.90|0.797
71904028|NCT01000727|143329662|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.546|TWO_SIDED|95.0|0.87|1.07|||Cox Proportional Hazard Regression Model||A hazard ratio \<1 indicates a lower risk with this treatment compared to Placebo|||1.07|0.87|0.546
71904029|NCT01000727|143329663|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.362|TWO_SIDED|95.0|0.81|1.08|||Cox Proportional Hazard Regression Model|||||1.08|0.81|0.362
71904030|NCT02207478|143329664|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.019
71904031|NCT02207478|143329665|SUPERIORITY_OR_OTHER|||||||0.843|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total procedure time||||0.843
71904032|NCT02207478|143329665|SUPERIORITY_OR_OTHER|||||||0.233|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Total X-ray time||||0.233
71904033|NCT02207478|143329665|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Duration time for finding lesions||||<0.001
71904034|NCT02207478|143329665|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||X-ray time for finding lesions||||<0.001
71904035|NCT00922194|143329719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.36|STANDARD_DEVIATION|3.3|<|0.05||95.0|-9.03|-7.72|||Paired t test|||Analysis of difference between 12 months or more and baseline values||-7.72|-9.03|<0.05
71904036|NCT00922194|143329720|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.27|||<|0.05||95.0|-3.5|-3.0|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months or more and baseline values||-3.0|-3.5|<0.05
71904037|NCT00922194|143329721|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.41|||<|0.05||95.0|-8.37|-6.47|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-6.47|-8.37|<0.05
71904038|NCT00922194|143329722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.014|||<|0.05||95.0|-0.02|0.001|||Wilcoxon paired sign rank-sum test|||Analysis of difference between 12 months or more and baseline values||0.001|-0.02|<0.05
71904039|NCT00922194|143329723|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-4.61|||<|0.05||95.0|-5.2|-3.8|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-3.8|-5.2|<0.05
71853564|NCT01106586|143220903|NON_INFERIORITY_OR_EQUIVALENCE|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA \< 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.0|||||TWO_SIDED|95.2|-1.9|7.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA \< 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.||7.8|-1.9|
71853565|NCT00938041|143220917|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
71821942|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.002
71821943|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.4||0.44|TWO_SIDED|95.0|-4.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-4.0|0.44
71821944|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.21|TWO_SIDED|95.0|-5.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-5.0|0.21
71821945|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-7.0|<0.001
71821946|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.029|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.029
71821947|NCT02886728|143145994|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.01|TWO_SIDED|95.0|-6.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-6.0|0.010
71821948|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.4|<|0.001|TWO_SIDED|95.0|-15.0|-9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-9.0|-15.0|<0.001
71853566|NCT00938041|143220917|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with confirmed complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.|||40|10|
71904040|NCT00922194|143329724|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.97|||<|0.05||95.0|-3.57|-2.38|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.38|-3.57|<0.05
71821949|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-11.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-11.0|<0.001
71821950|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
71853567|NCT00404547|143220965|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.||||<0.0001
71680461|NCT05897827|142878994|OTHER|To test for within-arm statistical significance of the change in Implement Intervention Decisions, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.14||||0.37|TWO_SIDED|95.0|-0.16|0.44||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.44|-0.16|0.37
71853568|NCT01614899|143220973|SUPERIORITY||LS Mean difference|-4.8||||0.05|TWO_SIDED|95.0|-9.52|0.0|||Mixed Model for Repeated Measures|||||0.00|-9.52|0.050
71853569|NCT01614899|143220973|SUPERIORITY||LS Mean difference|-4.2||||0.08|TWO_SIDED|95.0|-8.91|0.5|||Mixed Model for Repeated Measures|||||0.50|-8.91|0.080
71853570|NCT01614899|143220974|SUPERIORITY||LS Mean difference|-0.08||||0.594|TWO_SIDED|95.0|-0.354|0.203|||Mixed Model for Repeated Measures|||||0.203|-0.354|0.594
71853571|NCT01614899|143220974|SUPERIORITY||LS Mean difference|-0.18||||0.199|TWO_SIDED|95.0|-0.453|0.095|||Mixed Model for Repeated Measures|||||0.095|-0.453|0.199
71821951|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-16.0|-10.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-16.0|<0.001
71821952|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
71821953|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-13.0|-6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-13.0|<0.001
71821954|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-15.0|-8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-15.0|<0.001
71853572|NCT01614899|143220975|SUPERIORITY||LS Mean difference|-1.1||||0.143|TWO_SIDED|95.0|-2.6|0.38|||Mixed Model for Repeated Measures|||||0.38|-2.60|0.143
71853573|NCT01614899|143220975|SUPERIORITY||LS Mean difference|-1.9||||0.01|TWO_SIDED|95.0|-3.4|-0.46|||Mixed Model for Repeated Measures|||||-0.46|-3.40|0.010
71853574|NCT01614899|143220976|SUPERIORITY||LS Mean difference|-1.0||||0.116|TWO_SIDED|95.0|-2.27|0.25|||Mixed Model for Repeated Measures|||||0.25|-2.27|0.116
71853575|NCT01614899|143220976|SUPERIORITY||LS Mean difference|-0.5||||0.388|TWO_SIDED|95.0|-1.8|0.7|||Mixed Model for Repeated Measures|||||0.70|-1.80|0.388
71853576|NCT01614899|143220977|SUPERIORITY||LS Mean difference|-2.5||||0.036|TWO_SIDED|95.0|-4.87|-0.17|||Mixed Model for Repeated Measures|||||-0.17|-4.87|0.036
71853577|NCT01614899|143220977|SUPERIORITY||LS Mean difference|-1.6||||0.174|TWO_SIDED|95.0|-3.93|0.72|||Mixed Model for Repeated Measures|||||0.72|-3.93|0.174
71853578|NCT02350127|143220981|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|1.22||0.14|TWO_SIDED|95.0|-0.59|4.18|||Mixed Models Analysis|||adjusted for participant baseline MOCA, robust VCE||4.18|-0.59|0.14
71853579|NCT02350127|143220981|SUPERIORITY||Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|1.4||0.03|TWO_SIDED|95.0|0.2|5.6|||Mixed Models Analysis|||restricted to completers||5.6|0.2|0.03
71853580|NCT02350127|143220982|SUPERIORITY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.52||0.68|TWO_SIDED|95.0|-1.23|0.8|||Mixed Models Analysis||Adjusting for baseline participant MOCA scores, robust vce.|||0.80|-1.23|0.68
71853581|NCT02350127|143220983|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|1.32||0.7|TWO_SIDED|95.0|-3.09|2.08|||Mixed Models Analysis|||adjusting for baseline participant MOCA, robust VCE||2.08|-3.09|0.70
71853582|NCT02350127|143220984|SUPERIORITY||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|2.2||0.02|TWO_SIDED|95.0|0.8|9.4|||Mixed Models Analysis|||||9.4|0.8|0.02
71853583|NCT02350127|143220985|SUPERIORITY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|4.3||0.47|TWO_SIDED|95.0|-5.4|11.6|||Mixed Models Analysis|||||11.6|-5.4|0.47
71853584|NCT02350127|143220986|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.54||0.99|TWO_SIDED|95.0|-1.1|1.1|||Mixed Models Analysis|||||1.1|-1.1|0.99
71853585|NCT02350127|143220987|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|3.7||0.98|TWO_SIDED|95.0|-7.4|7.2|||Mixed Models Analysis|||||7.2|-7.4|0.98
71853586|NCT02350127|143220988|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|1.5||0.8|TWO_SIDED|95.0|-2.5|3.3|||Mixed Models Analysis|||||3.3|-2.5|0.80
71853587|NCT02350127|143220989|SUPERIORITY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|1.1||0.38|TWO_SIDED|95.0|-3.1|1.2|||Mixed Models Analysis|||||1.2|-3.1|0.38
71853588|NCT02350127|143220990|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.45||0.075|TWO_SIDED|95.0|-1.7|0.1|||Mixed Models Analysis|||||0.1|-1.7|0.075
71853589|NCT02350127|143220991|SUPERIORITY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.7||0.35|TWO_SIDED|95.0|-1.7|5.0|||Mixed Models Analysis|||||5.0|-1.7|0.35
71853590|NCT02350127|143220992|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.35|TWO_SIDED|95.0|-6.1|2.1|||Mixed Models Analysis|||||2.1|-6.1|0.35
71853591|NCT02350127|143220993|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.54|TWO_SIDED|95.0|-0.4|0.8|||Mixed Models Analysis|||||0.8|-0.4|0.54
71680462|NCT05897827|142878995|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.44|||<|0.001|TWO_SIDED|95.0|0.28|0.59||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.59|0.28|<0.001
71680463|NCT05897827|142878995|OTHER|To test for within-arm statistical significance, we used linear mixed models accounting for within-person clustering using random effects. We reported the beta coefficients and 95% confidence intervals.|Mean Difference (Net)|0.49|||<|0.001|TWO_SIDED|95.0|0.29|0.69||Threshold for statistical significance: \<0.05|Mixed Models Analysis|||||0.69|0.29|<0.001
71680464|NCT00197002|142878997|NON_INFERIORITY_OR_EQUIVALENCE|"The two-sided standardized asymptotic 95% confidence interval (CI) for the difference in seropositivity rates \[Havrix+Prevnar Group minus Havrix Group\] was computed. The anti-HAV seropositivity rates in the Havrix+Prevnar Group were considered as non-inferior to the seropositivity rates in the Havrix Group, if the lower limit of the 95% CI was not lower (≥) than -5%.~The non-inferiority was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Difference in seropositivity rate|-1.06|||||TWO_SIDED|95.0|-5.78|2.45||||||"Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10)."||2.45|-5.78|
71680465|NCT00197002|142878998|NON_INFERIORITY_OR_EQUIVALENCE|"The standardized two-sided 95% CI for the GMC ratio (Havrix+Prevnar Group divided by Havrix Group) was computed. The anti-HAV GMC in the Havrix+Prevnar Group was considered as non-inferior to the anti-HAV GMC in the Havrix Group if the lower limit of the 95% CI was not lower than (≥) 0.5.~The non-inferiority of the anti-HAV immune response in Havrix+Prevnar Group compared to Havrix Group was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Adjusted GMC ratio|0.91|||||TWO_SIDED|95.0|0.63|1.31|||ANCOVA|||To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).||1.31|0.63|
71680466|NCT02017717|142879016|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
71680467|NCT02017717|142879017|SUPERIORITY||Difference of OS rates at 12 months|-0.5||||0.9208|TWO_SIDED|95.0|-10.8|9.7|||Z test with variance estimation based on|Greenwood formula using log(-log) transformation||||9.7|-10.8|0.9208
71853592|NCT02350127|143220994|SUPERIORITY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.9||0.69|TWO_SIDED|95.0|-1.5|2.2|||Mixed Models Analysis|||||2.2|-1.5|0.69
71680468|NCT02017717|142879019|SUPERIORITY||Hazard Ratio (HR)|1.88|||||TWO_SIDED|95.0|1.5|2.35||||||||2.35|1.50|
71680469|NCT02017717|142879020|SUPERIORITY||Odds Ratio (OR)|0.29|||||TWO_SIDED|95.0|0.15|0.59||||||||0.59|0.15|
71680470|NCT02017717|142879021|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.3791|TWO_SIDED|95.0|0.89|1.36|||log-rank test stratified|||||1.36|0.89|0.3791
71680471|NCT02276053|142879032|OTHER||Retention rate|86.0|||||TWO_SIDED|95.0|79.0|93.1|||||"Confidence intervals for the 6-month retention rate were calculated using Greenwood's formula.~Addition of a note: Not all patients had an Observation Period of 6 months."|The retention rate was derived using Kaplan-Meier methodology where patients who completed the study were censored at the date of last administration of LCM in the study.||93.1|79.0|
71853593|NCT02350127|143220995|SUPERIORITY||Median Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.2||0.88|TWO_SIDED|95.0|-10.9|9.3|||Mixed Models Analysis|||||9.3|-10.9|0.88
71853594|NCT02350127|143220996|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.26|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.26
71853595|NCT02350127|143220997|SUPERIORITY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|1.1||0.08|TWO_SIDED|95.0|-3.9|0.2|||Mixed Models Analysis|||||0.2|-3.9|0.08
71853596|NCT03906240|143221002|SUPERIORITY||Cohen's d|1.44|||<|0.001|TWO_SIDED|95.0|1.0|2.49|||t-test, 2 sided|t = 5.78||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||2.49|1.00|<.001
71853597|NCT03906240|143221002|SUPERIORITY||Cohen's d|0.78||||0.002|TWO_SIDED|95.0|0.35|1.38|||t-test, 2 sided|t = 3.48||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.38|0.35|.002
71853598|NCT03906240|143221003|SUPERIORITY||Cohen's d|0.01||||0.957|TWO_SIDED|95.0|-0.45|0.91|||t-test, 2 sided|t = 0.06||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.91|-0.45|.957
71853599|NCT03906240|143221003|SUPERIORITY||Cohen's d|0.51||||0.033|TWO_SIDED|95.0|0.08|1.25|||t-test, 2 sided|t = 2.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.25|0.08|.033
71853600|NCT03906240|143221004|SUPERIORITY||Cohen's d|0.71||||0.015|TWO_SIDED|95.0|0.32|1.31|||t-test, 2 sided|t = 2.76||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.31|0.32|.015
71853601|NCT03906240|143221004|SUPERIORITY||Cohen's d|0.74||||0.012|TWO_SIDED|95.0|0.26|1.55|||t-test, 2 sided|t = 2.87||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||1.55|0.26|.012
71853602|NCT03906240|143221004|SUPERIORITY||Cohen's d|0.02||||0.941|TWO_SIDED|95.0|-0.43|0.55|||t-test, 2 sided|t = 0.08||Physical Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.55|-0.43|.941
71853603|NCT03906240|143221004|SUPERIORITY||Cohen's d|0.25||||0.27|TWO_SIDED|95.0|-0.17|0.79|||t-test, 2 sided|t = 1.14||Psychological Domain: Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.79|-0.17|.270
71853604|NCT03906240|143221005|SUPERIORITY||Cohen's d|0.08||||0.768|TWO_SIDED|95.0|-0.45|0.71|||t-test, 2 sided|t = 0.30||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.71|-0.45|.768
71853605|NCT03906240|143221005|SUPERIORITY||Cohen's d|0.01||||0.975|TWO_SIDED|95.0|-0.53|0.42|||t-test, 2 sided|t = 0.05||Paired-samples t-test to conduct within-person comparison between baseline and follow-up.||0.42|-0.53|.975
71853606|NCT04405089|143221025|OTHER||Linear regression|0.03|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus Binge Eating Scale score at baseline).||||
71853607|NCT04405089|143221026|OTHER||Linear regression|-0.33|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Flanker score at baseline).||||
71680472|NCT04542499|142879057|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||1.653|0.553|<0.0001
71821955|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.1||0.019|TWO_SIDED|95.0|-9.0|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-9.0|0.019
71821956|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.1||0.007|TWO_SIDED|95.0|-10.0|-2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-10.0|0.007
71821957|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
71821958|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|2.0||0.13|TWO_SIDED|95.0|-7.0|1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-7.0|0.13
71821959|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.0||0.047|TWO_SIDED|95.0|-8.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-8.0|0.047
71821960|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-11.0|-4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-11.0|<0.001
71821961|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.34|TWO_SIDED|95.0|-6.0|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-6.0|0.34
71821962|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.1||0.46|TWO_SIDED|95.0|-6.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-6.0|0.46
71821963|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-9.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-12.0|-5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-12.0|<0.001
71821964|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.2||0.03|TWO_SIDED|95.0|-9.0|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-9.0|0.030
71821965|NCT02886728|143145995|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-12.0|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-12.0|<0.001
71821966|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-10.78|STANDARD_ERROR_OF_MEAN|0.983|<|0.001|TWO_SIDED|95.0|-12.71|-8.85||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.85|-12.71|<0.001
71853608|NCT04405089|143221027|OTHER||Linear regression|0.04|||||TWO_SIDED|||||||||Linear regression (number of traumatic brain injuries versus NIH Set Shifting score at baseline).||||
71680473|NCT04542499|142879058|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||||-0.410|-1.475|0.0006
71680474|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.188||0.2216|TWO_SIDED|95.0|-0.6|0.139||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.139|-0.600|0.2216
71680475|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|0.099|STANDARD_ERROR_OF_MEAN|0.211||0.6379|TWO_SIDED|95.0|-0.316|0.515||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.515|-0.316|0.6379
71680476|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|0.582|STANDARD_ERROR_OF_MEAN|0.234||0.0132|TWO_SIDED|95.0|0.122|1.042||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||1.042|0.122|0.0132
71904041|NCT00922194|143329725|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.37|||<|0.05||95.0|-2.65|-2.08|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values||-2.08|-2.65|<0.05
71904042|NCT03072719|143329730|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-0.19||||0.1774|TWO_SIDED|95.0|-0.46|0.09||From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate.|ANCOVA||Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero."||0.09|-0.46|0.1774
71904043|NCT04507867|143329811|OTHER|Kaplan-Meier method for overall survival.||||||0.027|||||||Log Rank|||The total number of patients who did or did not survive to day 40 of follow-up.||||0.027
71904044|NCT04507867|143329813|OTHER|Kaplan-Meier method||||||0.495|||||||Log Rank|||the total number of patients who were intubated and survived at the end of day 40 follow-up.||||0.495
71904045|NCT04507867|143329815|OTHER|Kaplan-Meier method||||||0.186|||||||Log Rank|||total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.||||0.186
71904046|NCT04507867|143329816|SUPERIORITY|Fisher exact test||||||0.35|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay. It was categorized as follows: 1. normal bristol scale at day 3; 2. abnormal bristol scale at day 3.||||0.35
71904047|NCT04507867|143329817|SUPERIORITY|||||||0.043|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.043
71904048|NCT04507867|143329818|SUPERIORITY|||||||0.241|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.||||0.241
71680477|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|0.358|STANDARD_ERROR_OF_MEAN|0.236||0.1299|TWO_SIDED|95.0|-0.106|0.821||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||0.821|-0.106|0.1299
71680478|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|0.698|STANDARD_ERROR_OF_MEAN|0.257||0.0068|TWO_SIDED|95.0|0.194|1.202||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||1.202|0.194|0.0068
71680479|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|0.969|STANDARD_ERROR_OF_MEAN|0.254||0.0002|TWO_SIDED|95.0|0.469|1.469||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||1.469|0.469|0.0002
71904049|NCT04507867|143329819|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Intragroup analysis at the control group, the measurement was performed at baseline and at hospital discharge.||||0.187
71904050|NCT04507867|143329819|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Intragroup analysis at the intervention group, the measurement was performed at baseline and at hospital discharge.||||0.003
71904051|NCT04507867|143329820|SUPERIORITY|||||||0.919|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.919
71904052|NCT04507867|143329820|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.||||0.014
71904053|NCT04507867|143329821|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||Intragroup analysis of the control group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.608
71904054|NCT04507867|143329821|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||Intragroup analysis of the intervention group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.||||0.04
71904055|NCT04507867|143329822|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.||||0.014
71680480|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|0.879|STANDARD_ERROR_OF_MEAN|0.259||0.0008|TWO_SIDED|95.0|0.369|1.389||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||1.389|0.369|0.0008
71904056|NCT04507867|143329823|SUPERIORITY|||||||0.008|||||||Fisher Exact|the shapiro wilk test was used to analyze the distribution of the data.||Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.||||0.008
71904057|NCT04507867|143329825|SUPERIORITY|Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||||0.078|||||||Fisher Exact|||||||0.078
71904058|NCT04507867|143329826|SUPERIORITY|||||||0.098|||||||t-test, 1 sided|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded||||0.098
71904059|NCT04507867|143329827|OTHER|||||||0.195|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group to analyze the presentation of post covid syndrome at the end of follow-up at day 40.||||0.195
71904060|NCT04507867|143329828|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.135
71904061|NCT04507867|143329829|SUPERIORITY|||||||0.266|||||||Fisher Exact|||Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.||||0.266
71904062|NCT04507867|143329830|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.002|||||||Fisher Exact|||||||0.002
71904063|NCT04507867|143329831|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.003|||||||Fisher Exact|||||||0.003
71904064|NCT04507867|143329832|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.004|||||||Fisher Exact|||||||0.004
71904065|NCT04507867|143329833|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.011|||||||Fisher Exact|||||||0.011
71904066|NCT04507867|143329834|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.031|||||||Fisher Exact|||||||0.031
71680481|NCT04542499|142879059|SUPERIORITY||LS Mean of Difference|1.103|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|0.553|1.653||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||1.653|0.553|<0.0001
71680482|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|0.108|STANDARD_ERROR_OF_MEAN|0.18||0.5471|TWO_SIDED|95.0|-0.245|0.461||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 2||0.461|-0.245|0.5471
71904067|NCT04507867|143329835|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.04|||||||Fisher Exact|||||||0.040
71904068|NCT04507867|143329836|SUPERIORITY|Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients||||||0.047|||||||Fisher Exact|||||||0.047
71904069|NCT01106625|143329845|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-0.904|-0.524|||ANCOVA|||||-0.524|-0.904|<0.001
71904070|NCT01106625|143329845|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.097|<|0.001|TWO_SIDED|95.0|-1.114|-0.732|||ANCOVA|||||-0.732|-1.114|<0.001
71904071|NCT01106625|143329846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.42|||<|0.001|TWO_SIDED|95.0|2.48|7.87|||Regression, Logistic|||||7.87|2.48|<0.001
71904072|NCT01106625|143329846|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|95.0|4.86|15.95|||Regression, Logistic|||||15.95|4.86|<0.001
71904073|NCT01106625|143329847|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-22.3|STANDARD_ERROR_OF_MEAN|4.627|<|0.001|TWO_SIDED|95.0|-31.53|-13.16|||ANCOVA|||||-13.16|-31.53|<0.001
71904074|NCT01106625|143329847|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-34.6|STANDARD_ERROR_OF_MEAN|4.692|<|0.001|TWO_SIDED|95.0|-43.86|-25.42|||ANCOVA|||||-25.42|-43.86|<0.001
71904075|NCT01106625|143329848|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.7|||ANCOVA|||||-0.7|-2.1|<0.001
71904076|NCT01106625|143329848|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.7|-1.3|||ANCOVA|||||-1.3|-2.7|<0.001
71904077|NCT01106625|143329849|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.24|STANDARD_ERROR_OF_MEAN|1.262||0.077|TWO_SIDED|95.0|-4.719|0.241|||ANCOVA|||||0.241|-4.719|0.077
71904078|NCT01106625|143329849|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.62|STANDARD_ERROR_OF_MEAN|1.266||0.201|TWO_SIDED|95.0|-4.111|0.866|||ANCOVA|||||0.866|-4.111|0.201
71680483|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-0.237|STANDARD_ERROR_OF_MEAN|0.205||0.2488|TWO_SIDED|95.0|-0.64|0.166||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 5||0.166|-0.640|0.2488
71680484|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-0.818|STANDARD_ERROR_OF_MEAN|0.221||0.0002|TWO_SIDED|95.0|-1.252|-0.384||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 8||-0.384|-1.252|0.0002
71680485|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-0.753|STANDARD_ERROR_OF_MEAN|0.227||0.001|TWO_SIDED|95.0|-1.199|-0.307||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 11||-0.307|-1.199|0.0010
71680486|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-0.904|STANDARD_ERROR_OF_MEAN|0.254||0.0004|TWO_SIDED|95.0|-1.403|-0.405||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 14||-0.405|-1.403|0.0004
71680487|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-1.024|STANDARD_ERROR_OF_MEAN|0.256|<|0.0001|TWO_SIDED|95.0|-1.528|-0.52||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 18||-0.520|-1.528|<0.0001
71680488|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-0.979|STANDARD_ERROR_OF_MEAN|0.261||0.0002|TWO_SIDED|95.0|-1.493|-0.465||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 22||-0.465|-1.493|0.0002
71680489|NCT04542499|142879060|SUPERIORITY||LS Mean of Difference|-0.943|STANDARD_ERROR_OF_MEAN|0.271||0.0006|TWO_SIDED|95.0|-1.475|-0.41||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Week 26||-0.410|-1.475|0.0006
71680490|NCT04542499|142879061|SUPERIORITY||LS Mean of Difference|0.4|STANDARD_ERROR_OF_MEAN|0.4||0.3265|TWO_SIDED|95.0|-0.4|1.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part I||1.2|-0.4|0.3265
71680491|NCT04542499|142879061|SUPERIORITY||LS Mean of Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.52||0.0203|TWO_SIDED|95.0|-2.2|-0.2||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part II||-0.2|-2.2|0.0203
71821967|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|1.207|<|0.001|TWO_SIDED|95.0|-11.13|-6.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.39|-11.13|<0.001
71821968|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-9.64|STANDARD_ERROR_OF_MEAN|1.2|<|0.001|TWO_SIDED|95.0|-12.0|-7.29||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.29|-12.00|<0.001
71821969|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-9.92|STANDARD_ERROR_OF_MEAN|0.884|<|0.001|TWO_SIDED|95.0|-11.65|-8.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.19|-11.65|<0.001
71853609|NCT03751280|143221028|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|90.0|-1.4|2.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||2.6|-1.4|
71680492|NCT04542499|142879061|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.96||0.0118|TWO_SIDED|95.0|-4.3|-0.5||LS Means, SE, difference from placebo, and confidence intervals are estimated using a mixed effects repeated measures model with fixed effects for treatment group, visits, and treatment by visit interaction and baseline as a covariate.|Mixed-effect Model Repeated Measurement|||Part III||-0.5|-4.3|0.0118
71680493|NCT05711381|142879062|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|0.91|||||TWO_SIDED|90.0|0.59|1.41||||||||1.41|0.59|
71680494|NCT05711381|142879063|OTHER|PK parameters of HM15912 from the severe renal impairment group (Cohort 2) were to be estimated and compared to the control group (Cohort 1, normal renal function). A one-way analysis of variance (ANOVA) was to be used to compare log transformed PK parameters. The estimates of mean difference and corresponding 90% CIs, as well as each exponentiation of estimates, were to be presented to provide the estimates of GMR.|Geometric mean ratio|1.25|||||TWO_SIDED|90.0|0.93|1.68||||||||1.68|0.93|
71904079|NCT01106625|143329850|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.4||0.256|TWO_SIDED|95.0|-16.9|4.5|||ANCOVA|||||4.5|-16.9|0.256
71904080|NCT01106625|143329850|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|5.5||0.571|TWO_SIDED|95.0|-13.8|7.6|||ANCOVA|||||7.6|-13.8|0.571
71904081|NCT01106625|143329851|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.7||0.153|TWO_SIDED|95.0|-0.9|5.9|||ANCOVA|||||5.9|-0.9|0.153
71904082|NCT01106625|143329851|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|1.8||0.056|TWO_SIDED|95.0|-0.1|6.8|||ANCOVA|||||6.8|-0.1|0.056
71904083|NCT01088438|143329857|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.||||<0.001
71904084|NCT01088438|143329858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|1 degree of freedom||Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.||||<.001
71904085|NCT01088438|143329859|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Chi-squared|1 df||Null hypothesis is equal proportion of encounters probed in control and intervention groups.||||0.85
71904086|NCT00511342|143329862|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.078||||0.19|TWO_SIDED|95.0|-0.198|0.041||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for lumbar spine (L2-L4)|||0.041|-0.198|0.19
71680495|NCT02407132|142879077|SUPERIORITY|||||||0.038||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.038
71904087|NCT00511342|143329862|SUPERIORITY_OR_OTHER_LEGACY||Difference of adjusted means|-0.03||||0.57|TWO_SIDED|95.0|-0.136|0.075||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for femoral neck|||0.075|-0.136|0.57
71904088|NCT01496430|143329870|SUPERIORITY_OR_OTHER|||||||0.007||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.007
71904089|NCT01496430|143329870|SUPERIORITY_OR_OTHER|||||||0.067||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.067
71688692|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.17|STANDARD_ERROR_OF_MEAN|0.56||0.0006|TWO_SIDED|90.0|1.21|3.12|||t-test, 2 sided|||FEV1/FVC Day 1 (0.25 hrs post-dose)||3.12|1.21|0.0006
71904090|NCT01496430|143329871|SUPERIORITY_OR_OTHER|||||||0.86||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.860
71904091|NCT01496430|143329871|SUPERIORITY_OR_OTHER|||||||0.21||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA|||||||0.210
71904092|NCT02402218|143329920|SUPERIORITY|||||||0.11||||||For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.|Chi-squared|||Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.||||.11
71904093|NCT02402218|143329921|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||.22
71904094|NCT02402218|143329923|SUPERIORITY|||||||0.33|||||||Chi-squared|||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.||||0.33
71904095|NCT02402218|143329924|SUPERIORITY|||||||0.3||||||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|Chi-squared|||||||0.30
71904096|NCT03807739|143329926|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2471|||||TWO_SIDED|90.0|1.1149|1.3951||||||||1.3951|1.1149|
71904097|NCT03807739|143329926|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9864|||||TWO_SIDED|90.0|0.8531|1.1405||||||||1.1405|0.8531|
71904098|NCT03807739|143329928|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|1.2203|||||TWO_SIDED|90.0|1.1175|1.3327||||||||1.3327|1.1175|
71904099|NCT03807739|143329928|EQUIVALENCE|Equivalence margin 80% - 125%|Geometric LS Mean Ratio|0.9947|||||TWO_SIDED|90.0|0.8266|1.1968||||||||1.1968|0.8266|
71904100|NCT00516269|143329996|SUPERIORITY_OR_OTHER||mean difference in treat versus control|0.42|STANDARD_DEVIATION|3.3||0.54||95.0|||||Wilcoxon signed rank test|||As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 \& period 2) was used to assess the treatment effect (A versus B).||||0.54
71904101|NCT01552928|143330008|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
71680496|NCT02407132|142879078|SUPERIORITY|||||||0.234||||||The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.234
71680497|NCT02407132|142879079|SUPERIORITY|||||||0.019||||||The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.019
71680498|NCT02407132|142879080|SUPERIORITY|||||||0.186||||||The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.||||0.186
71680499|NCT02407132|142879081|SUPERIORITY|||||||0.04||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.040
71680500|NCT02407132|142879082|SUPERIORITY|||||||0.312||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed Effects Logistic Regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.312
71680501|NCT02407132|142879083|SUPERIORITY|||||||0.622||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.622
71680502|NCT02407132|142879084|SUPERIORITY|||||||0.957||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.957
71680503|NCT02407132|142879085|SUPERIORITY|||||||0.147||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.147
71680504|NCT02407132|142879086|SUPERIORITY|||||||0.326||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.||||0.326
71680505|NCT03617861|142879090|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.12
71680506|NCT03617861|142879090|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.65
71904102|NCT01552928|143330008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71680507|NCT03617861|142879090|SUPERIORITY|||||||0.0574|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.0574
71904103|NCT01552928|143330008|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71853610|NCT03751280|143221028|OTHER||Comparison of adjusted least square mean|0.8|STANDARD_ERROR_OF_MEAN|1.279|||TWO_SIDED|90.0|-1.3|2.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||2.9|-1.3|
71680508|NCT03617861|142879091|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
71853611|NCT03751280|143221028|OTHER||Comparison of adjusted least square mean|2.73|STANDARD_ERROR_OF_MEAN|1.611||0.0931|TWO_SIDED|90.0|0.1|5.4|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||5.4|0.1|0.0931
71853612|NCT03751280|143221030|OTHER||Comparison of adjusted least square mean|0.21|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-0.6|1.0|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1|-0.6|
71904104|NCT01552928|143330009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904105|NCT01552928|143330009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904106|NCT01552928|143330009|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71904107|NCT01552928|143330010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||ANCOVA|||||||0.012
71904108|NCT01552928|143330010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044|||||||ANCOVA|||||||0.044
71904109|NCT01552928|143330010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904110|NCT01552928|143330011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904111|NCT01552928|143330011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904112|NCT01552928|143330011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904113|NCT01552928|143330012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|||||||0.003
71904114|NCT01552928|143330012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904115|NCT01552928|143330012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|||||||ANCOVA|||||||0.043
71904116|NCT01552928|143330017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904117|NCT01552928|143330017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904118|NCT01552928|143330017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904119|NCT01552928|143330018|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904120|NCT01552928|143330018|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904121|NCT01552928|143330018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||ANCOVA|||||||0.004
71904122|NCT01552928|143330019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANCOVA|||||||0.005
71904123|NCT01552928|143330019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904124|NCT01552928|143330019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904125|NCT01552928|143330020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078|||||||ANCOVA|||||||0.078
71904126|NCT01552928|143330020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904127|NCT01552928|143330020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.156|||||||ANCOVA|||||||0.156
71904128|NCT01552928|143330021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.439|||||||ANCOVA|||||||0.439
71904129|NCT01552928|143330021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||ANCOVA|||||||0.274
71904130|NCT01552928|143330021|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71904131|NCT04030104|143330022|SUPERIORITY|||||||0.0268||||||Threshold for statistical significance \<0.05|Random Reader, Random Mass|Curve Fitting Method: Empirical||||||0.0268
71904132|NCT01079962|143330026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.701||||0.5943|TWO_SIDED|95.0|-1.89|3.29||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||Change in APP at Week 12: p-value was calculated by 2 sided t-test.||3.29|-1.89|0.5943
71904133|NCT01079962|143330027|SUPERIORITY_OR_OTHER|||||||0.8589||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.8589
71904134|NCT01079962|143330027|SUPERIORITY_OR_OTHER|||||||0.2223||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.2223
71904135|NCT01079962|143330027|SUPERIORITY_OR_OTHER|||||||0.2443||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2443
71904136|NCT01079962|143330027|SUPERIORITY_OR_OTHER|||||||0.1481||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.1481
71904137|NCT01079962|143330027|SUPERIORITY_OR_OTHER|||||||0.4188||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.4188
71904138|NCT01079962|143330027|SUPERIORITY_OR_OTHER|||||||0.1586||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1586
71904139|NCT01079962|143330028|SUPERIORITY_OR_OTHER|||||||0.2987||95.0|||||t-test, 2 sided|||Change in AIx at Week 4: p-value was calculated by 2 sided t-test.||||0.2987
71904140|NCT01079962|143330028|SUPERIORITY_OR_OTHER|||||||0.6584||95.0|||||t-test, 2 sided|||Change in AIx at Week 12: p-value was calculated by 2 sided t-test.||||0.6584
71904141|NCT01079962|143330029|SUPERIORITY_OR_OTHER|||||||0.2511||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.||||0.2511
71904142|NCT01079962|143330029|SUPERIORITY_OR_OTHER|||||||0.5007||95.0|||||t-test, 2 sided|||Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.||||0.5007
71904143|NCT01079962|143330030|SUPERIORITY_OR_OTHER|||||||0.9943||95.0|||||t-test, 2 sided|||Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.||||0.9943
71904144|NCT01079962|143330030|SUPERIORITY_OR_OTHER|||||||0.523||95.0|||||t-test, 2 sided|||Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.||||0.5230
71904145|NCT01079962|143330031|SUPERIORITY_OR_OTHER|||||||0.4447||95.0|||||t-test, 2 sided|||||||0.4447
71904146|NCT01079962|143330032|SUPERIORITY_OR_OTHER|||||||0.396||95.0|||||t-test, 2 sided|||Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.3960
71904147|NCT01079962|143330032|SUPERIORITY_OR_OTHER|||||||0.1919||95.0|||||t-test, 2 sided|||Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1919
71904148|NCT01079962|143330032|SUPERIORITY_OR_OTHER|||||||0.1896||95.0|||||t-test, 2 sided|||Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.||||0.1896
71904149|NCT01079962|143330033|SUPERIORITY_OR_OTHER|||||||0.9244||95.0|||||t-test, 2 sided|||||||0.9244
71904150|NCT01079962|143330034|SUPERIORITY_OR_OTHER|||||||0.9692||95.0|||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.||||0.9692
71904151|NCT01079962|143330034|SUPERIORITY_OR_OTHER|||||||0.4731||95.0|||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.||||0.4731
71904152|NCT01079962|143330034|SUPERIORITY_OR_OTHER|||||||0.2876||95.0|||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.||||0.2876
71904153|NCT01079962|143330034|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.||||0.0420
71904154|NCT01079962|143330034|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.||||0.5100
71904155|NCT01079962|143330034|SUPERIORITY_OR_OTHER|||||||0.1207||95.0|||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.||||0.1207
71904156|NCT01079962|143330036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.442||||0.7561||95.0|-2.36|3.24||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||||3.24|-2.36|0.7561
71904157|NCT01008995|143330077|SUPERIORITY_OR_OTHER||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \[\<=65 kg vs \> 65 kg). The power was \>99% for both sample size assumptions.||||<0.001
71904158|NCT01008995|143330078|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight \[≤ 65kg vs \> 65 kg)\].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
71904159|NCT01008995|143330079|SUPERIORITY_OR_OTHER||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \> 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.||||<0.001
71904160|NCT02702518|143330092|OTHER||||||<|0.001||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||<0.001
71904161|NCT02702518|143330092|OTHER|||||||0.2324||||||p-values were calculated via linear quantile mixed model for continuous variables with missing data.|Mixed Models Analysis|||For the outcome measure corneal staining data at week 8 was compared with data at baseline to determine significant change.||||0.2324
71904162|NCT02702518|143330093|OTHER|||||||0.001||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI, data at week 8 was compared with data at baseline to determine if a change was significant (threshold p \< 0.05).||||0.001
71904163|NCT02702518|143330093|OTHER|||||||0.2257||||||p-values were calculated via linear quantile mixed model for continuous variables.|Mixed Models Analysis|||For the outcome measure OSDI data at week 8 was compared with data at baseline to determine significant change.||||0.2257
71904164|NCT00165841|143330094|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value was adjusted for multiple comparisons.|t-test, 2 sided|The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.||Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.||||<0.0001
71904165|NCT00333619|143330135|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANOVA|||||||0.10
71904166|NCT00333619|143330136|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
71904167|NCT00831441|143330163|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.5094|TWO_SIDED|95.0|0.8|1.11|||Cox proportional hazard models|||A test of superiority at the one-sided α = 0.025 significance level for the primary efficacy outcome was performed.||1.11|0.80|0.5094
71904168|NCT00831441|143330164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.6702|TWO_SIDED|95.0|0.7|1.26|||Cox proportional hazard models|||||1.26|0.70|0.6702
71904169|NCT00831441|143330165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.6311|TWO_SIDED|95.0|0.57|1.4|||Cox proportional hazard models|||||1.40|0.57|0.6311
71904170|NCT00831441|143330166|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5086|TWO_SIDED|95.0|0.76|1.14|||Cox proportional hazard models|||||1.14|0.76|0.5086
71904171|NCT00831441|143330167|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1502|TWO_SIDED|95.0|0.47|1.12|||Cox proportional hazard models|||||1.12|0.47|0.1502
71904172|NCT00831441|143330168|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.4317|TWO_SIDED|95.0|0.82|1.09|||Cox proportional hazard models|||||1.09|0.82|0.4317
71904173|NCT00831441|143330169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.8015|TWO_SIDED|95.0|0.83|1.15|||Cox proportional hazard models|||||1.15|0.83|0.8015
71904174|NCT00831441|143330170|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8948|TWO_SIDED|95.0|0.85|1.15|||Cox proportional hazard models|||||1.15|0.85|0.8948
71904175|NCT00831441|143330171|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.59||||0.0006|TWO_SIDED|95.0|1.5|4.46|||Cox Proportional Hazard model|||A point estimate and two-sided 95% confidence interval (CI) for relative risk, as measured by the hazard ratio and a p-value for the test of equality of rates (HR = 1) was calculated.||4.46|1.50|0.0006
71904176|NCT00831441|143330172|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48|||<|0.0001|TWO_SIDED|95.0|1.72|3.58|||Cox Proportional Hazard model|||||3.58|1.72|<0.0001
71904177|NCT00831441|143330173|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.87|3.72|||Cox Proportional Hazard model|||||3.72|1.87|<0.0001
71904178|NCT00831441|143330174|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36|||<|0.0001|TWO_SIDED|95.0|2.06|2.7|||Cox Proportional Hazard model|||||2.70|2.06|<0.0001
71904179|NCT00960934|143330182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.56||||0.749|TWO_SIDED|95.0|-1.04|2.16||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.16|-1.04|0.749
71904180|NCT00960934|143330182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.12||||0.333|TWO_SIDED|95.0|-0.6|2.83||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.83|-0.60|0.333
71904181|NCT00960934|143330182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.35||||0.823|TWO_SIDED|95.0|-1.14|1.84||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.84|-1.14|0.823
71904182|NCT00960934|143330182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.93||||0.457|TWO_SIDED|95.0|-0.75|2.61||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.61|-0.75|0.457
71904183|NCT00960934|143330182|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.823|TWO_SIDED|95.0|-1.17|1.5||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.50|-1.17|0.823
71904184|NCT00960934|143330183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.8|||<|0.001||95.0|56.5|80.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||80.0|56.5|<0.001
71904185|NCT00960934|143330183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.1|||<|0.001|TWO_SIDED|95.0|39.6|65.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||65.2|39.6|<0.001
71904186|NCT00960934|143330183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6|||<|0.001|TWO_SIDED|95.0|17.6|42.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.4|17.6|<0.001
71904187|NCT00960934|143330183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.1|||<|0.001|TWO_SIDED|95.0|17.0|42.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||42.0|17.0|<0.001
71904188|NCT00960934|143330183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.254|TWO_SIDED|95.0|-4.1|14.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||14.4|-4.1|0.254
71904189|NCT00960934|143330184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.6|||<|0.001|TWO_SIDED|95.0|34.9|60.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||60.0|34.9|<0.001
71904190|NCT00960934|143330184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.9|||<|0.001|TWO_SIDED|95.0|24.1|48.5|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||48.5|24.1|<0.001
71904191|NCT00960934|143330184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.2||||0.001|TWO_SIDED|95.0|7.7|28.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||28.7|7.7|0.001
71821970|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-8.34|STANDARD_ERROR_OF_MEAN|1.086|<|0.001|TWO_SIDED|95.0|-10.47|-6.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.21|-10.47|<0.001
71904192|NCT00960934|143330184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1||||0.05|TWO_SIDED|95.0|0.0|18.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||18.2|-0.0|0.050
71904193|NCT00960934|143330184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.313|TWO_SIDED|95.0|-8.5|4.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||4.2|-8.5|0.313
71680509|NCT03617861|142879091|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.82
71680510|NCT03617861|142879091|SUPERIORITY|||||||0.1451|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.1451
71680511|NCT03617861|142879092|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.85
71680512|NCT03617861|142879092|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
71904194|NCT00960934|143330185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.8|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.8|-5.8|>0.999
71904195|NCT00960934|143330185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
71904196|NCT00960934|143330185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||>|0.999|TWO_SIDED|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||5.7|-5.8|>0.999
71904197|NCT00960934|143330185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.313|TWO_SIDED|95.0|-4.2|8.6|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.6|-4.2|0.313
71904198|NCT00960934|143330185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.321|TWO_SIDED|95.0|-4.3|8.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.||8.4|-4.3|0.321
71904199|NCT00960934|143330187|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-1.03|1.51||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.51|-1.03|0.959
71904200|NCT00960934|143330187|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.02||||0.971|TWO_SIDED|95.0|-1.08|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.08|0.971
71904201|NCT00960934|143330187|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.24||||0.959|TWO_SIDED|95.0|-0.95|1.42||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.42|-0.95|0.959
71680513|NCT03617861|142879092|SUPERIORITY|||||||0.4233|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.4233
71904202|NCT00960934|143330187|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.41||||0.915|TWO_SIDED|95.0|-1.78|0.97||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.97|-1.78|0.915
71904203|NCT00960934|143330187|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.959|TWO_SIDED|95.0|-1.6|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.04|-1.60|0.959
71904204|NCT00960934|143330188|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.58||||0.849|TWO_SIDED|95.0|-1.22|2.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.37|-1.22|0.849
71680514|NCT03617861|142879093|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Healthy Controls Secretin vs Healthy Controls Placebo||||0.92
71904205|NCT00960934|143330188|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.16||||0.964|TWO_SIDED|95.0|-1.79|1.47||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.47|-1.79|0.964
71904206|NCT00960934|143330188|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.964|TWO_SIDED|95.0|-1.27|1.59||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.59|-1.27|0.964
71904207|NCT00960934|143330188|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.48||||0.855|TWO_SIDED|95.0|-2.23|1.27||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.27|-2.23|0.855
71680515|NCT03617861|142879093|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||1.0
71680516|NCT03617861|142879093|SUPERIORITY|||||||0.3891|||||||ANCOVA|||Healthy Controls vs Functional Dyspepsia||||0.3891
71680517|NCT03617861|142879094|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Healthy Secretin vs Healthy Placebo||||0.004
71680518|NCT03617861|142879094|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.03
71680519|NCT03617861|142879094|SUPERIORITY|||||||0.0355|||||||ANCOVA|||Healthy vs Functional Dyspepsia||||0.0355
71680520|NCT03617861|142879095|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Nausea: Healthy Controls Secretin vs Healthy Controls Placebo||||0.5
71904208|NCT00960934|143330188|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.27||||0.287|TWO_SIDED|95.0|-0.58|3.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.12|-0.58|0.287
71904209|NCT00960934|143330189|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.6||||0.933|TWO_SIDED|95.0|-1.56|2.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.77|-1.56|0.933
71904210|NCT00960934|143330189|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.01||||0.999|TWO_SIDED|95.0|-1.69|1.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.68|-1.69|0.999
71904211|NCT00960934|143330189|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.05||||0.999|TWO_SIDED|95.0|-1.84|1.93||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.93|-1.84|0.999
71904212|NCT00960934|143330189|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.45||||0.959|TWO_SIDED|95.0|-1.67|2.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.57|-1.67|0.959
71904213|NCT00960934|143330189|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.08||||0.999|TWO_SIDED|95.0|-2.1|1.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.94|-2.10|0.999
71904214|NCT00960934|143330190|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.17||||0.976|TWO_SIDED|95.0|-1.12|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.77|-1.12|0.976
71904215|NCT00960934|143330190|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.06||||0.982|TWO_SIDED|95.0|-0.93|0.8||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.80|-0.93|0.982
71904216|NCT00960934|143330190|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.53||||0.489|TWO_SIDED|95.0|-0.43|1.49||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.49|-0.43|0.489
71904217|NCT00960934|143330190|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.02||||0.982|TWO_SIDED|95.0|-0.75|0.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||0.78|-0.75|0.982
71904218|NCT00960934|143330190|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.16||||0.976|TWO_SIDED|95.0|-0.76|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.08|-0.76|0.976
71904219|NCT00960934|143330191|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.35||||0.961|TWO_SIDED|95.0|-2.0|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.31|-2.00|0.961
71904220|NCT00960934|143330191|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.28||||0.961|TWO_SIDED|95.0|-1.9|1.34||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.34|-1.90|0.961
71904221|NCT00960934|143330191|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.66||||0.778|TWO_SIDED|95.0|-1.01|2.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.33|-1.01|0.778
71821971|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.08|<|0.001|TWO_SIDED|95.0|-9.45|-5.21||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.21|-9.45|<0.001
71904222|NCT00960934|143330191|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.11||||0.961|TWO_SIDED|95.0|-1.45|1.24||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.24|-1.45|0.961
71904223|NCT00960934|143330191|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.25||||0.961|TWO_SIDED|95.0|-1.77|1.26||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.26|-1.77|0.961
71904224|NCT00960934|143330192|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.43||||0.901|TWO_SIDED|95.0|-2.03|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.03|0.901
71904225|NCT00960934|143330192|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.51||||0.901|TWO_SIDED|95.0|-2.18|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.17|-2.18|0.901
71821972|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-5.98|STANDARD_ERROR_OF_MEAN|0.808|<|0.001|TWO_SIDED|95.0|-7.56|-4.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.39|-7.56|<0.001
71821973|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|0.987|<|0.001|TWO_SIDED|95.0|-6.14|-2.27||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.27|-6.14|<0.001
71821974|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-4.34|STANDARD_ERROR_OF_MEAN|0.993|<|0.001|TWO_SIDED|95.0|-6.29|-2.39||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.39|-6.29|<0.001
71821975|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-5.27|STANDARD_ERROR_OF_MEAN|1.003|<|0.001|TWO_SIDED|95.0|-7.24|-3.31||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.31|-7.24|<0.001
71821976|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-3.29|STANDARD_ERROR_OF_MEAN|1.222||0.007|TWO_SIDED|95.0|-5.68|-0.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.89|-5.68|0.007
71821977|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-4.61|STANDARD_ERROR_OF_MEAN|1.229|<|0.001|TWO_SIDED|95.0|-7.02|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.20|-7.02|<0.001
71821978|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|0.974|<|0.001|TWO_SIDED|95.0|-5.35|-1.53||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.53|-5.35|<0.001
71853613|NCT03751280|143221030|OTHER||Comparison of adjusted least square mean|0.61|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-0.3|1.5|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.5|-0.3|
71853614|NCT03751280|143221030|OTHER||Comparison of adjusted least square mean|0.82|STANDARD_ERROR_OF_MEAN|0.648||0.2069|TWO_SIDED|90.0|-0.3|1.9|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||1.9|-0.3|0.2069
71853615|NCT03751280|143221031|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.849|||TWO_SIDED|90.0|-0.9|1.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.9|-0.9|
71853616|NCT03751280|143221031|OTHER||Comparison of adjusted least square mean|0.12|STANDARD_ERROR_OF_MEAN|0.89|||TWO_SIDED|90.0|-1.4|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.6|-1.4|
71853617|NCT03751280|143221031|OTHER||Comparison of adjusted least square mean|1.61|STANDARD_ERROR_OF_MEAN|1.071||0.1368|TWO_SIDED|90.0|-0.2|3.4|||t-test, 2 sided|||Day 85||3.4|-0.2|0.1368
71853618|NCT03751280|143221032|OTHER||Comparison of adjusted least square mean|-0.13|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.8|0.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||0.6|-0.8|
71853619|NCT03751280|143221032|OTHER||Comparison of adjusted least square mean|0.15|STANDARD_ERROR_OF_MEAN|0.453|||TWO_SIDED|90.0|-0.6|0.9|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||0.9|-0.6|
71904226|NCT00960934|143330192|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.52||||0.901|TWO_SIDED|95.0|-2.17|1.13||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.13|-2.17|0.901
71853620|NCT03751280|143221032|OTHER||Comparison of adjusted least square mean|0.51|STANDARD_ERROR_OF_MEAN|0.581||0.3798|TWO_SIDED|90.0|-0.5|1.5|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|||1.5|-0.5|0.3798
71904227|NCT00960934|143330192|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.03||||0.997|TWO_SIDED|95.0|-1.29|1.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.35|-1.29|0.997
71904228|NCT00960934|143330192|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.04||||0.997|TWO_SIDED|95.0|-1.51|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.43|-1.51|0.997
71904229|NCT00960934|143330193|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.37||||0.979|TWO_SIDED|95.0|-2.73|1.99||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||1.99|-2.73|0.979
71904230|NCT00960934|143330193|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|1.92||||0.363|TWO_SIDED|95.0|-1.1|4.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||4.95|-1.10|0.363
71904231|NCT00960934|143330193|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.4||||0.979|TWO_SIDED|95.0|-2.18|2.98||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.98|-2.18|0.979
71904232|NCT00960934|143330193|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.49||||0.979|TWO_SIDED|95.0|-3.27|2.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||2.30|-3.27|0.979
71904233|NCT00960934|143330193|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|0.51||||0.979|TWO_SIDED|95.0|-2.34|3.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||3.37|-2.34|0.979
71904234|NCT00960934|143330194|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.77||||0.02|TWO_SIDED|95.0|2.26|37.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.46|2.26|0.020
71904235|NCT00960934|143330194|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.08||||0.357|TWO_SIDED|95.0|-6.16|26.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||26.41|-6.16|0.357
71904236|NCT00960934|143330194|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-2.83||||0.642|TWO_SIDED|95.0|-14.81|9.14||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||9.14|-14.81|0.642
71904237|NCT00960934|143330194|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.44||||0.434|TWO_SIDED|95.0|-7.09|24.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.04|-7.09|0.434
71904238|NCT00960934|143330194|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.72||||0.579||95.0|-8.62|20.1||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||20.10|-8.62|0.579
71904239|NCT00960934|143330195|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|34.26|||<|0.001|TWO_SIDED|95.0|15.27|53.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||53.56|15.27|<0.001
71680521|NCT03617861|142879095|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Nausea: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.16
71680522|NCT03617861|142879095|SUPERIORITY|||||||0.0016|||||||ANCOVA|||Nausea: Healthy Controls vs Functional Dyspepsia||||0.0016
71904240|NCT00960934|143330195|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.57||||0.014|TWO_SIDED|95.0|3.28|38.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||38.02|3.28|0.014
71904241|NCT00960934|143330195|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.97||||0.307|TWO_SIDED|95.0|-5.69|25.7||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||25.70|-5.69|0.307
71904242|NCT00960934|143330195|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|9.02||||0.307|TWO_SIDED|95.0|-5.85|23.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||23.95|-5.85|0.307
71904243|NCT00960934|143330195|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|-0.5||||0.937|TWO_SIDED|95.0|-12.92|11.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||11.92|-12.92|0.937
71904244|NCT00960934|143330196|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|19.19|||<|0.001|TWO_SIDED|95.0|7.42|31.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||31.02|7.42|<0.001
71904245|NCT00960934|143330196|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|23.38|||<|0.001|TWO_SIDED|95.0|11.02|35.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||35.82|11.02|<0.001
71904246|NCT00960934|143330196|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|10.45||||0.061|TWO_SIDED|95.0|-0.37|21.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||21.30|-0.37|0.061
71821979|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.72|-1.09||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.09|-5.72|0.004
71821980|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-2.12|STANDARD_ERROR_OF_MEAN|1.18||0.072|TWO_SIDED|95.0|-4.44|0.19||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.19|-4.44|0.072
71821981|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-4.79|STANDARD_ERROR_OF_MEAN|0.789|<|0.001|TWO_SIDED|95.0|-6.34|-3.24||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.24|-6.34|<0.001
71821982|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|0.957||0.002|TWO_SIDED|95.0|-4.88|-1.13||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.13|-4.88|0.002
71821983|NCT02886728|143145996|SUPERIORITY||Least Squares Mean Difference|-3.77|STANDARD_ERROR_OF_MEAN|0.957|<|0.001|TWO_SIDED|95.0|-5.65|-1.89||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.89|-5.65|<0.001
71821984|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|19.7|||<|0.001|TWO_SIDED|95.0|12.8|26.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||26.7|12.8|<0.001
71821985|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|16.3|||<|0.001|TWO_SIDED|95.0|7.6|25.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||25.0|7.6|<0.001
71821986|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|11.7||||0.004|TWO_SIDED|95.0|3.0|20.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||20.4|3.0|0.004
71821987|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|11.7|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||25.2|11.7|<0.001
71821988|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|7.1||||0.083|TWO_SIDED|95.0|-1.6|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|-1.6|0.083
71821989|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.4|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||23.1|6.4|<0.001
71904247|NCT00960934|143330196|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|6.31||||0.283|TWO_SIDED|95.0|-3.81|16.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||16.45|-3.81|0.283
71680523|NCT03617861|142879095|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Fullness: Healthy Controls Secretin vs Healthy Controls Placebo||||0.10
71680524|NCT03617861|142879095|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Fullness: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.30
71821990|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|10.6|||<|0.001|TWO_SIDED|95.0|4.4|16.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||16.7|4.4|<0.001
71821991|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|4.7||||0.22|TWO_SIDED|95.0|-3.1|12.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||12.6|-3.1|0.22
71853621|NCT03751280|143221033|OTHER||Comparison of adjusted least square mean|-0.79|STANDARD_ERROR_OF_MEAN|-0.79|||TWO_SIDED|90.0|-3.2|1.6|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29||1.6|-3.2|
71853622|NCT03751280|143221033|OTHER||Comparison of adjusted least square mean|-1.6|STANDARD_ERROR_OF_MEAN|2.006|||TWO_SIDED|90.0|-4.9|1.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 57||1.7|-4.9|
71853623|NCT03751280|143221033|OTHER||Comparison of adjusted least square mean|-4.07|STANDARD_ERROR_OF_MEAN|1.78||0.0245|TWO_SIDED|90.0|-7.0|-1.1|||t-test, 2 sided||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 85||-1.1|-7.0|0.0245
71853624|NCT03751280|143221034|OTHER||Comparison of adjusted least square mean|-0.18|STANDARD_ERROR_OF_MEAN|0.516|||TWO_SIDED|90.0|-1.0|0.7|||||mixed effects model with treatment, visit as fixed effects, baseline and disease duration at baseline as continuous covariates, treatment \* visit and baseline \* visit interaction effects.|Day 29-Domain 1||0.7|-1.0|
71853625|NCT02162771|143221074|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|102.25|||||TWO_SIDED|90.0|94.05|111.17|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in AUCtau between CT-P10 and Rituxan||111.17|94.05|
71853626|NCT02162771|143221075|EQUIVALENCE|The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|100.67|||||TWO_SIDED|90.0|93.84|108.0|||ANCOVA|Country, gender, race, the value of ECOG status and the FLIPI score (0 to 2 versus 3 to 5) at baseline were fitted as covariates.||Equivalence in Cmax,ss between CT-P10 and Rituxan||108.00|93.84|
71853627|NCT02162771|143221076|NON_INFERIORITY|Non-inferiority margin of -7% was predefined.|Point estimate difference|4.3|||||TWO_SIDED|||||||||||||
71853628|NCT03594266|143221133|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
71853629|NCT03594266|143221133|OTHER||||||<|0.0001|||||||paired t-test, two-sided|||||||<0.0001
71853630|NCT03594266|143221134|OTHER|||||||0.5482|||||||two-sample t-test, 2-sided|||||||0.5482
71680525|NCT03617861|142879095|SUPERIORITY|||||||0.0002|||||||ANCOVA|||Fullness: Healthy Controls vs Functional Dyspepsia||||0.0002
71680526|NCT03617861|142879095|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Bloating: Healthy Controls Secretin vs Healthy Controls Placebo||||0.41
71680527|NCT03617861|142879095|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Bloating Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.67
71680528|NCT03617861|142879095|SUPERIORITY|||||||0.033|||||||ANCOVA|||Bloating: Healthy Controls vs Functional Dyspepsia||||0.0330
71680529|NCT03617861|142879095|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Healthy Controls Secretin vs Healthy Controls Placebo||||0.25
71821992|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|4.3||||0.25|TWO_SIDED|95.0|-3.6|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||12.1|-3.6|0.25
71853631|NCT03647709|143221139|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.9|1.2|||||Represents patients pain score post operative day 1 best with rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||1.2|0.9|
71853632|NCT03647709|143221139|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 1 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.||2.6|2.2|
71853633|NCT03647709|143221139|OTHER||mean score|2.9|||||TWO_SIDED|95.0|2.7|3.1|||||Represents patients reported pain score post operative day 1 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.1|2.7|
71853634|NCT03647709|143221139|OTHER||mean score|4.6|||||TWO_SIDED|95.0|4.4|4.8|||||Represents patients reported pain score post operative day 1 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.8|4.4|
71853635|NCT03647709|143221139|OTHER||mean score|1.8|||||TWO_SIDED|95.0|1.6|2.0|||||Represents patients reported pain score post operative day 2 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.6|
71853636|NCT03647709|143221139|OTHER||mean score|3.4|||||TWO_SIDED|95.0|3.2|3.6|||||Represents patients reported pain score post operative day 2 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.6|3.2|
71853637|NCT03647709|143221139|OTHER||mean score|4.2|||||TWO_SIDED|95.0|4.0|4.4|||||Represents patients reported pain score post operative day 2 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.4|4.0|
71680530|NCT03617861|142879095|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Abdominal Pain: Functional Dyspepsia Secretin vs Functional Dyspepsia Placebo||||0.57
71680531|NCT03617861|142879095|SUPERIORITY|||||||0.2375|||||||ANCOVA|||Abdominal Pain: Healthy Controls vs Functional Dyspepsia||||0.2375
71680532|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Week 12||||0.101
71821993|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|2.7||||0.35|TWO_SIDED|95.0|-3.5|8.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||8.9|-3.5|0.35
71821994|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|4.6||||0.2|TWO_SIDED|95.0|-2.9|12.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||12.1|-2.9|0.20
71821995|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|3.1||||0.36|TWO_SIDED|95.0|-4.5|10.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||10.6|-4.5|0.36
71680533|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.139|||||||Paired t-test|||Statistical analysis at Week 24||||0.139
71680534|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Week 36||||0.116
71680535|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.167|||||||Paired t-test|||Statistical analysis at Week 48||||0.167
71680536|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.21|||||||Paired t-test|||Statistical analysis at Week 56||||0.210
71821996|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|6.3||||0.043|TWO_SIDED|95.0|-0.2|12.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||12.8|-0.2|0.043
71821997|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|9.4||||0.015|TWO_SIDED|95.0|1.6|17.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||17.2|1.6|0.015
71853638|NCT03647709|143221139|OTHER||mean score|5.9|||||TWO_SIDED|95.0|5.7|6.1|||||Represents patients reported pain score post operative day 2 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||6.1|5.7|
71680537|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.343|||||||Paired t-test|||Statistical analysis at Week 68||||0.343
71680538|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.533|||||||Paired t-test|||Statistical analysis at Week 80||||0.533
71680539|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.593|||||||Paired t-test|||Statistical analysis at Week 92||||0.593
71821998|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|6.5||||0.085|TWO_SIDED|95.0|-1.5|14.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||14.4|-1.5|0.085
71821999|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|9.9||||0.002|TWO_SIDED|95.0|3.2|16.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||16.6|3.2|0.002
71680540|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.044|||||||Paired t-test|||Statistical analysis at Week 104||||0.044
71680541|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.243|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.243
71680542|NCT01668966|142879140|SUPERIORITY_OR_OTHER|||||||0.009|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.009
71680543|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.1853|||||||Paired t-test|||Statistical analysis at Week 12||||0.1853
71680544|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.2992|||||||Paired t-test|||Statistical analysis at Week 24||||0.2992
71680545|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.2249|||||||Paired t-test|||Statistical analysis at Week 36||||0.2249
71680546|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.3102|||||||Paired t-test|||Statistical analysis at Week 48||||0.3102
71680547|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.2164|||||||Paired t-test|||Statistical analysis at Week 56||||0.2164
71680548|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.8822|||||||Paired t-test|||Statistical analysis at Week 68||||0.8822
71680549|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.7649|||||||Paired t-test|||Statistical analysis at Week 80||||0.7649
71680550|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.605|||||||Paired t-test|||Statistical analysis at Week 92||||0.6050
71680551|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.4478|||||||Paired t-test|||Statistical analysis at Week 104||||0.4478
71680552|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.4821|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4821
71680553|NCT01668966|142879141|SUPERIORITY_OR_OTHER|||||||0.0522|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0522
71680554|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Week 12||||0.0624
71680555|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.0616|||||||Paired t-test|||Statistical analysis at Week 24||||0.0616
71822000|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|10.5||||0.01|TWO_SIDED|95.0|2.3|18.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||18.7|2.3|0.010
71822001|NCT02886728|143145997|SUPERIORITY||Difference in Response Rates|9.6||||0.014|TWO_SIDED|95.0|1.4|17.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||17.8|1.4|0.014
71853639|NCT03647709|143221139|OTHER||mean score|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||Represents patients reported pain score post operative day 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.2|0.8|
71822002|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
71822003|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.7|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.7|<0.001
71822004|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
71853640|NCT03647709|143221139|OTHER||mean score|2.4|||||TWO_SIDED|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.6|2.2|
71853641|NCT03647709|143221139|OTHER||mean score|3.3|||||TWO_SIDED|95.0|3.1|3.5|||||Represents patients reported pain score post operative day 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.5|3.1|
71680556|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.248|||||||Paired t-test|||Statistical analysis at Week 36||||0.2480
71680557|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.5393|||||||Paired t-test|||Statistical analysis at Week 48||||0.5393
71853642|NCT03647709|143221139|OTHER||mean score|5.0|||||TWO_SIDED|95.0|4.8|5.2|||||Represents patients reported pain score post operative day 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||5.2|4.8|
71853643|NCT03647709|143221139|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative days 10-14 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
71680558|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.1401|||||||Paired t-test|||Statistical analysis at Week 56||||0.1401
71680559|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.0679|||||||Paired t-test|||Statistical analysis at Week 68||||0.0679
71680560|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.6017|||||||Paired t-test|||Statistical analysis at Week 80||||0.6017
71853644|NCT03647709|143221139|OTHER||mean score|2.1|||||TWO_SIDED|95.0|1.9|2.3|||||Represents patients reported pain score post operative days 10-14 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.3|1.9|
71853645|NCT03647709|143221139|OTHER||mean score|2.0|||||TWO_SIDED|95.0|1.8|2.2|||||Represents patients reported pain score post operative days 10-14 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.2|1.8|
71853646|NCT03647709|143221139|OTHER||mean score|4.0|||||TWO_SIDED|95.0|3.8|4.2|||||Represents patients reported pain score post operative days 10-14 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||4.2|3.8|
71853647|NCT03647709|143221139|OTHER||mean score|0.3|||||TWO_SIDED|95.0|0.2|0.4|||||Represents patients reported pain score post operative week 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.4|0.2|
71853648|NCT03647709|143221139|OTHER||mean score|1.5|||||TWO_SIDED|95.0|1.3|1.7|||||Represents patients reported pain score post operative week 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.7|1.3|
71853649|NCT03647709|143221139|OTHER||mean score|1.3|||||TWO_SIDED|95.0|1.2|1.5|||||Represents patients reported pain score post operative week 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||1.5|1.2|
71853650|NCT03647709|143221139|OTHER||mean score|3.1|||||TWO_SIDED|95.0|2.9|3.3|||||Represents patients reported pain score post operative week 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||3.3|2.9|
71853651|NCT03647709|143221139|OTHER||mean score|0.1|||||TWO_SIDED|95.0|0.0|0.2|||||Represents patients reported pain score post operative week 6 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.0|
71853652|NCT03647709|143221139|OTHER||mean score|0.7|||||TWO_SIDED|95.0|0.5|0.8|||||Represents patients reported pain score post operative week 6 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.8|0.5|
71904248|NCT00960934|143330196|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|5.46||||0.283|TWO_SIDED|95.0|-3.39|14.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||14.31|-3.39|0.283
71904249|NCT00960934|143330197|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|56.77|||<|0.001|TWO_SIDED|95.0|37.62|76.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||76.35|37.62|<.001
71680561|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.4772|||||||Paired t-test|||Statistical analysis at Week 92||||0.4772
71680562|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.4877|||||||Paired t-test|||Statistical analysis at Week 104||||0.4877
71680563|NCT01668966|142879142|SUPERIORITY_OR_OTHER|||||||0.0624|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.0624
71680564|NCT01668966|142879142|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||<0.0001
71680565|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.2388|||||||Paired t-test|||Statistical analysis at Week 12||||0.2388
71680566|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.1084|||||||Paired t-test|||Statistical analysis at Week 24||||0.1084
71680567|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.0321|||||||Paired t-test|||Statistical analysis at Week 36||||0.0321
71680568|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Paired t-test|||Statistical analysis at Week 48||||0.0203
71680569|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.0193|||||||Paired t-test|||Statistical analysis at Week 56||||0.0193
71853653|NCT03647709|143221139|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.6|||||Represents patients reported pain score post operative week 6 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.6|0.4|
71853654|NCT03647709|143221139|OTHER||mean score|1.9|||||TWO_SIDED|95.0|1.7|2.0|||||Represents patients reported pain score post operative week 6 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||2.0|1.7|
71853655|NCT03647709|143221139|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Represents patients reported pain score post operative week 12 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.0|-0.0|
71853656|NCT03647709|143221139|OTHER||mean score|0.2|||||TWO_SIDED|95.0|0.1|0.2|||||Represents patients reported pain score post operative week 12 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.2|0.1|
71853657|NCT03647709|143221139|OTHER||mean score|0.0|||||TWO_SIDED|95.0|0.0|0.1|||||Represents patients reported pain score post operative week 12 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.1|-0.0|
71680570|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.6235|||||||Paired t-test|||Statistical analysis at Week 68||||0.6235
71680571|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.2814|||||||Paired t-test|||Statistical analysis at Week 80||||0.2814
71680572|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.3391|||||||Paired t-test|||Statistical analysis at Week 92||||0.3391
71680573|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.1605|||||||Paired t-test|||Statistical analysis at Week 104||||0.1605
71680574|NCT01668966|142879143|SUPERIORITY_OR_OTHER|||||||0.4312|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.4312
71680575|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.934|||||||Paired t-test|||Statistical analysis at Week 12||||0.934
71680576|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.624|||||||Paired t-test|||Statistical analysis at Week 24||||0.624
71680577|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.642|||||||Paired t-test|||Statistical analysis at Week 36||||0.642
71822005|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.1|-0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.1|<0.001
71822006|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
71680578|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.952|||||||Paired t-test|||Statistical analysis at Week 48||||0.952
71680579|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.928|||||||Paired t-test|||Statistical analysis at Week 56||||0.928
71853658|NCT03647709|143221139|OTHER||mean score|0.5|||||TWO_SIDED|95.0|0.4|0.7|||||Represents patients reported pain score post operative week 12 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity||0.7|0.4|
71680580|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.832|||||||Paired t-test|||Statistical analysis at Week 68||||0.832
71680581|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.315|||||||Paired t-test|||Statistical analysis at Week 80||||0.315
71680582|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.485|||||||Paired t-test|||Statistical analysis at Week 92||||0.485
71853659|NCT03647709|143221142|OTHER|||||||0.0015|||||||Fisher Exact|||||||0.0015
71853660|NCT03647709|143221143|OTHER|||||||0.6398|||||||Fisher Exact|||||||.6398
71680583|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 104||||0.246
71680584|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.375|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.375
71680585|NCT01668966|142879146|SUPERIORITY_OR_OTHER|||||||0.185|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.185
71680586|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.445|||||||Paired t-test|||Statistical analysis at Week 12||||0.445
71680587|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.414|||||||Paired t-test|||Statistical analysis at Week 24||||0.414
71680588|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.401|||||||Paired t-test|||Statistical analysis at Week 36||||0.401
71680589|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.92|||||||Paired t-test|||Statistical analysis at Week 48||||0.920
71680590|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.834|||||||Paired t-test|||Statistical analysis at Week 56||||0.834
71680591|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.539|||||||Paired t-test|||Statistical analysis at Week 68||||0.539
71680592|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 80||||0.246
71680593|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.602|||||||Paired t-test|||Statistical analysis at Week 92||||0.602
71680594|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.218|||||||Paired t-test|||Statistical analysis at Week 104||||0.218
71680595|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.208|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.208
71680596|NCT01668966|142879147|SUPERIORITY_OR_OTHER|||||||0.101|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.101
71680597|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.565|||||||Paired t-test|||Statistical analysis at Week 12||||0.565
71680598|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.637|||||||Paired t-test|||Statistical analysis at Week 24||||0.637
71680599|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.594|||||||Paired t-test|||Statistical analysis at Week 36||||0.594
71680600|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.788|||||||Paired t-test|||Statistical analysis at Week 48||||0.788
71680601|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.329|||||||Paired t-test|||Statistical analysis at Week 56||||0.329
71680602|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.716|||||||Paired t-test|||Statistical analysis at Week 68||||0.716
71680603|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.119|||||||Paired t-test|||Statistical analysis at Week 80||||0.119
71680604|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.201|||||||Paired t-test|||Statistical analysis at Week 92||||0.201
71680605|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.087|||||||Paired t-test|||Statistical analysis at Week 104||||0.087
71680606|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.116|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.116
71680607|NCT01668966|142879148|SUPERIORITY_OR_OTHER|||||||0.07|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.070
71680608|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.3299|||||||Paired t-test|||Statistical analysis at Week 12||||0.3299
71680609|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.9247|||||||Paired t-test|||Statistical analysis at Week 24||||0.9247
71853661|NCT03647709|143221144|OTHER|||||||0.0658|||||||Fisher Exact|||||||.0658
71853662|NCT03647709|143221145|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71904250|NCT00960934|143330197|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|39.66|||<|0.001|TWO_SIDED|95.0|22.44|57.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||57.17|22.44|<.001
71680610|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.9602|||||||Paired t-test|||Statistical analysis at Week 36||||0.9602
71904251|NCT00960934|143330197|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|20.68||||0.003|TWO_SIDED|95.0|5.72|35.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||35.78|5.72|0.003
71904252|NCT00960934|143330197|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.59||||0.265|TWO_SIDED|95.0|-4.81|22.05||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||22.05|-4.81|0.265
71680611|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.2773|||||||Paired t-test|||Statistical analysis at Week 48||||0.2773
71680612|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.5031|||||||Paired t-test|||Statistical analysis at Week 56||||0.5031
71680613|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.8109|||||||Paired t-test|||Statistical analysis at Week 68||||0.8109
71680614|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.254|||||||Paired t-test|||Statistical analysis at Week 80||||0.2540
71680615|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.3794|||||||Paired t-test|||Statistical analysis at Week 92||||0.3794
71680616|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.8687|||||||Paired t-test|||Statistical analysis at Week 104||||0.8687
71680617|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.4685|||||||Paired t-test|||Statistical analysis at Follow-up visit 1||||0.4685
71680618|NCT01668966|142879149|SUPERIORITY_OR_OTHER|||||||0.0511|||||||Paired t-test|||Statistical analysis at Follow-up visit 2||||0.0511
71680619|NCT01643798|142879195|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71680620|NCT01643798|142879195|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71680621|NCT01643798|142879196|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||ANOVA|||||||.0003
71904253|NCT00960934|143330197|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|8.39||||0.265|TWO_SIDED|95.0|-3.4|20.21||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis|||||20.21|-3.40|0.265
71822007|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
71822008|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-1.0|-0.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.0|<0.001
71921892|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.2|14.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||14.1|-12.2|
71680622|NCT01643798|142879196|SUPERIORITY_OR_OTHER|||||||0.794||95.0|||||ANOVA|||||||0.794
71680623|NCT00614120|142879264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|-0.06|||<|0.0001||95.0|-0.23|0.11||Non-inferiority; \<.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.11|-0.23|<0.0001
71680624|NCT00614120|142879264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.03|||<|0.0001||95.0|-0.14|0.2||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.20|-0.14|<.0001
71680625|NCT00614120|142879264|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.25||||0.0421||95.0|0.08|0.42||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."||0.42|0.08|0.0421
71680626|NCT04789291|142879307|OTHER||Ratios of adjusted geometric means [%]|102.76|||||TWO_SIDED|90.0|99.34|106.29|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.8.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.29|99.34|
71680627|NCT04789291|142879308|OTHER||Ratios of adjusted geometric means [%]|77.81|||||TWO_SIDED|90.0|69.77|86.76|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 15.5.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||86.76|69.77|
71680628|NCT04789291|142879309|OTHER||Ratios of adjusted geometric means [%]|103.24|||||TWO_SIDED|90.0|99.73|106.89|||||Ratio calculated as test/reference\*100. Intra-individual Geometric coefficient of variation \[%\] = 4.9.|Relative bioavailability of BI 1595043 administered in fed state (Test) compared with BI 1595043 administered in fasted state (Reference) was estimated by the ratios of the gMeans (Test/Reference). Their corresponding 2-sided 90% CIs were provided. This method corresponds to 2 one-sided t-test procedures, each at the 5% significance level.||106.89|99.73|
71680629|NCT02484651|142879327|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Sample size calculation was performed with a power of 0.80 and an α of 0.05, considering the primary hypothesis of a reduction in the BIS variability (measured as the standard deviation). A 25% reduction on the BIS variability (standard deviation) was considered clinically relevant, and gave a minimum sample size of 26 per group.||||0.651
71904254|NCT00960934|143330198|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|53.05|||<|0.001|TWO_SIDED|95.0|37.83|68.53||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||68.53|37.83|<0.001
71904255|NCT00960934|143330198|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|41.41|||<|0.001|TWO_SIDED|95.0|27.36|55.65||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||55.65|27.36|<0.001
71904256|NCT00960934|143330198|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|24.81|||<|0.001|TWO_SIDED|95.0|12.39|37.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||37.33|12.39|<0.001
71904257|NCT00960934|143330198|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|12.87||||0.02|TWO_SIDED|95.0|1.73|24.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||24.06|1.73|0.020
71904258|NCT00960934|143330198|SUPERIORITY_OR_OTHER||LS Mean Difference in Change From BL|4.02||||0.397|TWO_SIDED|95.0|-5.31|13.36||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model|||||13.36|-5.31|0.397
71904259|NCT02338492|143330218|SUPERIORITY|||||||0.615||||||P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is \<0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.||Null hypothesis: Mean improvement in VAS over 90 days \<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).||||0.615
71904260|NCT02338492|143330220|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|96|
71680630|NCT02484651|142879328|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||This statistical analysis applies to the propofol effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the propofol drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on propofol mean effect-site concentration of 20% was considered clinically relevant, giving a minimum of 34 patients per group||||<0.001
71904261|NCT02338492|143330220|OTHER||Percentage of Subjects|100.0|||||TWO_SIDED|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals||100|96|
71680631|NCT02484651|142879328|SUPERIORITY|||||||0.245|||||||t-test, 2 sided|||"This statistical analysis applies to the remifentanil effect-site concentration.~Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group"||||0.245
71904262|NCT02338492|143330220|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||100|93|
71904263|NCT02338492|143330220|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success||100|93|
71904264|NCT02338492|143330220|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications||100|93|
71680632|NCT02484651|142879329|SUPERIORITY|||||||0.419|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 15 minutes was independent from the study group.||||0.419
71822009|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.8|-0.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.8|<0.001
71853663|NCT00449033|143221152|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.401||95.0|0.83|1.16|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.||1.16|0.83|0.401
71853664|NCT00449033|143221153|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.563||95.0|0.87|1.18|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.||||1.18|0.87|0.563
71853665|NCT00449033|143221155|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.008||95.0|0.71|0.97|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.97|0.71|0.008
71680633|NCT02484651|142879329|SUPERIORITY|||||||0.107|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 40 minutes was independent from the study group.||||0.107
71680634|NCT02484651|142879330|SUPERIORITY|||||||0.669|||||||Chi-squared|||The null hypothesis was that PQRS satisfaction with anesthetic care was independent of the study group.||||0.669
71680635|NCT01726036|142879427|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
71822010|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.9|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.9|<0.001
71822011|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.9|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-0.9|<0.001
71822012|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
71822013|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
71822014|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.6|<0.001
71822015|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.033|TWO_SIDED|95.0|-0.4|0.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-0.4|0.033
71822016|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
71822017|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.8|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-0.8|<0.001
71853666|NCT00449033|143221156|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.0004||95.0|0.6|0.88|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||0.88|0.60|0.0004
71904265|NCT02338492|143330220|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
71904266|NCT02338492|143330220|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||99|90|
71904267|NCT02338492|143330220|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success||99|90|
71904268|NCT02338492|143330220|OTHER||Percentage of Subjects|96.3|||||TWO_SIDED|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications||99|90|
71680636|NCT01390428|142879433|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio (GMR)|1.21|||||TWO_SIDED|90.0|0.73|2.01|||||Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI|Day 1||2.01|0.73|
71853667|NCT00449033|143221157|SUPERIORITY_OR_OTHER||Difference in Tumour Response (CR+PR)|-1.92||||0.2733||95.0|-8.19|4.34|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||4.34|-8.19|0.2733
71853668|NCT00449033|143221158|SUPERIORITY_OR_OTHER||Difference in Disease Control|0.97||||0.3902||95.0|-5.87|7.81|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||||7.81|-5.87|0.3902
71853669|NCT00024102|143221178|NON_INFERIORITY_OR_EQUIVALENCE|The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)|Hazard Ratio (HR)|2.09|||<|0.001|TWO_SIDED|95.0|1.38|3.17||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones|Regression, Cox|||||3.17|1.38|<0.001
71853670|NCT00024102|143221179|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.85||||0.02|TWO_SIDED|95.0|1.11|3.08||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.|Regression, Cox|||||3.08|1.11|0.02
71853671|NCT01770509|143221196|SUPERIORITY_OR_OTHER|||||||0.652|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.652
71853672|NCT01770509|143221197|SUPERIORITY_OR_OTHER|||||||0.645|||||||ANOVA|General Linear Model ANOVA with repeated measures||||||0.645
71853673|NCT00748098|143221204|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-26.0|||<|0.0001|TWO_SIDED|95.0|-35.64|-16.36|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-16.36|-35.64|<0.0001
71904269|NCT02338492|143330220|OTHER||Percentage of Subjects|98.8|||||TWO_SIDED|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals||100|93|
71680637|NCT01390428|142879433|SUPERIORITY_OR_OTHER||GMR|1.66|||||TWO_SIDED|90.0|1.05|2.61|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.61|1.05|
71680638|NCT01390428|142879433|SUPERIORITY_OR_OTHER||GMR|5.03|||||TWO_SIDED|90.0|2.19|11.56|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||11.56|2.19|
71680639|NCT01390428|142879433|SUPERIORITY_OR_OTHER||GMR|4.82|||||TWO_SIDED|90.0|2.6|8.93|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||8.93|2.60|
71853674|NCT00748098|143221205|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-3.07||||0.002|TWO_SIDED|95.0|-5.04|-1.1|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.||||-1.10|-5.04|0.002
71853675|NCT00925288|143221242|NON_INFERIORITY_OR_EQUIVALENCE|Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.|||||>|0.2||95.0|||||Regression, Logistic|||The null hypothesis is that both schedules will provide an equivalent antibody response.||||>0.20
71853676|NCT00925288|143221243|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||Completion rates compared in the 2 study arms||||0.60
71853677|NCT00925288|143221244|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Chi-squared|||comparison of differences in HPV DNA prevalence by study arm.||||0.53
71904270|NCT02338492|143330220|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||98|86|
71904271|NCT02338492|143330220|OTHER||Percentage of Subjects|92.6|||||TWO_SIDED|95.0|85.0|97.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success||97|85|
71853678|NCT01232569|143221246|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.5|||<|0.001|TWO_SIDED|95.0|22.0|37.0|||Cochran-Mantel-Haenszel|Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).||||37.0|22.0|<0.001
71853679|NCT04044352|143221264|OTHER|Likelihood ratio test was the statistical test.|Odds Ratio (OR)|0.81||||0.126|TWO_SIDED|95.0|0.62|1.06|||Wald Chi-Square||A two-fold increase in HAI pre-challenge titer (i.e. one unit increase in log-2 titer) corresponds to a 19% decrease in the odds of developing MMID during the study challenge period (Day 2 through Day 8).|Pre-challenge (baseline) HAI geometric mean titer was log-2 transformed and treated as a continuous variable in the model.||1.06|0.62|0.126
71853680|NCT00635570|143221311|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||Chi-squared, Corrected|Yates's chi-squared test with 1 degree of freedom was used for analysis||The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.||||0.05
71853681|NCT00635570|143221312|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED|0.0|||||Chi-squared, Corrected|||||||>0.05
71853682|NCT00635570|143221313|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71904272|NCT02338492|143330220|OTHER||Percentage of Subjects|93.8|||||TWO_SIDED|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications||98|86|
71904273|NCT02338492|143330220|OTHER||Percentage of Subjects|95.1|||||TWO_SIDED|95.0|88.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals||99|88|
71853683|NCT00635570|143221314|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71853684|NCT02552810|143221335|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculation, 30 (effect size: 0.5, alpha error: 0.05, power: 0.80).|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71904274|NCT02338492|143330220|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||93|77|
71853685|NCT00396097|143221409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.033||0.5762|ONE_SIDED|97.5|-0.071||||ANCOVA|||The null hypothesis was that the individualized treatment arm was not superior to the standard treatment arm; alternative hypothesis that the individualized treatment arm was superior to the standard treatment arm with respect to the mean 24-month AOTD. Using a 2:1 randomization, a two sided sample t-test comparing the root AOTD between the 2 treatment arms with 80% power at a 5% level required 260 subjects. Assuming a 20% attrition rate, approximately 312 subjects were needed for this study.|||-0.071|0.5762
71853686|NCT00396097|143221410|SUPERIORITY_OR_OTHER|||||||0.627|TWO_SIDED||||||ANOVA (Levene's Test)|||||||0.627
71853687|NCT00396097|143221411|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.033||||0.8016|TWO_SIDED|95.0|0.802|1.33|||Regression, Cox|||||1.330|0.802|0.8016
71853688|NCT00396097|143221412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.822|STANDARD_ERROR_OF_MEAN|2.25||0.0101|TWO_SIDED|95.0|1.395|10.249|||ANCOVA|||||10.249|1.395|0.0101
71853689|NCT00396097|143221412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.281|STANDARD_ERROR_OF_MEAN|2.471||0.0002|TWO_SIDED|95.0|4.417|14.145|||ANCOVA|||||14.145|4.417|0.0002
71853690|NCT00396097|143221412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.204|STANDARD_ERROR_OF_MEAN|2.495||0.2001|TWO_SIDED|95.0|-1.707|8.114|||ANCOVA|||||8.114|-1.707|0.2001
71853691|NCT00396097|143221413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.899|STANDARD_ERROR_OF_MEAN|3.414|<|0.0001|TWO_SIDED|95.0|30.181|43.618|||ANCOVA|||||43.618|30.181|<0.0001
71853692|NCT00396097|143221413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.517|STANDARD_ERROR_OF_MEAN|3.284|<|0.0001|TWO_SIDED|95.0|42.054|54.98|||ANCOVA|||||54.980|42.054|<.0001
71904275|NCT02338492|143330220|OTHER||Percentage of Subjects|86.4|||||TWO_SIDED|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success||93|77|
71904276|NCT02338492|143330220|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications||96|83|
71853693|NCT00396097|143221413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.443|STANDARD_ERROR_OF_MEAN|3.306|<|0.0001|TWO_SIDED|95.0|27.936|40.951|||ANCOVA|||||40.951|27.936|<.0001
71853694|NCT00396097|143221414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.081||0.2618|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|||||0.249|-0.068|0.2618
71853695|NCT00396097|143221414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.094||0.8926|TWO_SIDED|95.0|-0.172|0.198|||ANCOVA|||||0.198|-0.172|0.8926
71853696|NCT00396097|143221414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.095||0.9566|TWO_SIDED|95.0|-0.192|0.181|||ANCOVA|||||0.181|-0.192|0.9566
71853697|NCT04086576|143221449|SUPERIORITY||||||<|0.0001||||||Yes, used Tukey Kramer pairwise comparisons to adjust for multiple comparisons|ANOVA|ANOVA in repeated measures||Each breathalyzer is compared to the percentage of alcohol in the blood during the time of blood draw (90 minutes).||||<.0001
71853698|NCT00475735|143221533|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.341
71853699|NCT00475735|143221533|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.||||||0.001
71853700|NCT00125853|143221582|OTHER|"Linear Mixed effect Modelling, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) = 0.05 (0.09)"||||||0.6|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on ISI||||0.60
71853701|NCT00125853|143221583|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -2.59 (1.34)"||||||0.06|||||||Linear Mixed effect Model, adjusted for|||Comparing treatment effects on ABPM||||0.06
71853702|NCT00125853|143221584|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0/09 (0.14)"||||||0.51|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on total cholesterol||||0.51
71853703|NCT00125853|143221585|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) =0.02 (0.03)"||||||0.48|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on HbA1c||||0.48
71853704|NCT00125853|143221586|OTHER|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0.21(0.13)"||||||0.09|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on BMI||||0.09
71853705|NCT03575572|143221592|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71853706|NCT03575572|143221592|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71853707|NCT03575572|143221594|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71853708|NCT03575572|143221594|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71853709|NCT00179478|143221595|SUPERIORITY|||||||0.001||||||Based on adjusted Hazard Ratio (HR)|Regression, Cox|HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions||||||0.001
71853710|NCT00179478|143221596|SUPERIORITY|||||||0.02||||||a priori threshold for statistical significance was a p value less than 0.01|Wilcoxon (Mann-Whitney)|||||||0.02
71853711|NCT00179478|143221597|SUPERIORITY|||||||0.61||||||a priori threshold for statistical significance was a p value \< 0.01|Fisher Exact|||||||0.61
71853712|NCT00179478|143221598|SUPERIORITY|||||||0.5||||||a priori threshold for statistical significant was a p value less than 0.01|Fisher Exact|||||||0.50
71853713|NCT00157209|143221600|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.745||||0.045|TWO_SIDED|95.0|0.533|1.042|||Log Rank|||||1.042|0.533|0.045
71853714|NCT04281875|143221635|SUPERIORITY|||||||0.6905|||||||t-test, 2 sided|||||||0.6905
71853715|NCT00577096|143221643|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.||||<0.025
71853716|NCT00577096|143221644|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.||||<0.025
71853717|NCT00577096|143221645|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared test to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|Analysis included short and long term participants.||||||<0.025
71853718|NCT00577096|143221646|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
71853719|NCT00577096|143221647|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||||||<0.025
71853720|NCT00577096|143221648|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.||||<0.025
71680640|NCT01390428|142879433|SUPERIORITY_OR_OTHER||GMR|19.83|||||TWO_SIDED|90.0|8.11|48.51|||||Severe HI/Healthy Matched to Severe HI|Day 1||48.51|8.11|
71853721|NCT00577096|143221649|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
71853722|NCT00577096|143221650|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.||||<0.025
71853723|NCT00577096|143221651|NON_INFERIORITY_OR_EQUIVALENCE|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||95.0||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.||||<0.025
71904277|NCT02338492|143330220|OTHER||Percentage of Subjects|91.4|||||TWO_SIDED|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals||96|83|
71680641|NCT01390428|142879433|SUPERIORITY_OR_OTHER||GMR|11.68|||||TWO_SIDED|90.0|6.1|22.35|||||Severe HI/Healthy Matched to Severe HI|Day 10||22.35|6.10|
71853724|NCT01370564|143221653|OTHER|There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.|Rao-Scott estimator for clustered data|72.0|||||TWO_SIDED|95.0|65.0|78.0||||||||78|65|
71853725|NCT02181400|143221663|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
71853726|NCT02181400|143221664|OTHER|||||||0.04|||||||ANCOVA|||||||0.04
71853727|NCT02181400|143221665|OTHER|||||||0.12|||||||ANCOVA|||||||0.12
71853728|NCT02181400|143221666|OTHER|||||||0.32|||||||ANCOVA|||||||0.32
71853729|NCT02181400|143221667|OTHER|||||||0.02|||||||ANCOVA|||||||0.02
71853730|NCT02181400|143221668|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
71853731|NCT00985621|143221669|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.44|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.44|-1.49|<0.001
71853732|NCT00985621|143221669|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.5|-0.43|||ANCOVA|||Analysis was performed using analysis of co-variance (ANCOVA) model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.50|<0.001
71853733|NCT00985621|143221670|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.49|-0.45|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.45|-1.49|<0.001
71904278|NCT02338492|143330220|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation||90|73|
71904279|NCT02338492|143330220|OTHER||Percentage of Subjects|82.7|||||TWO_SIDED|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success||90|73|
71904280|NCT01757405|143330229|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].|Ratio of success proportion|1.21|||||TWO_SIDED|90.0|1.15|1.28|||Ratio of success proportion|||Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms. Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 : p1/p2 \< 0.83 and H02 : p1/p2 \> 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as \[0.83, 1.20\].||1.28|1.15|
71680642|NCT01390428|142879434|SUPERIORITY_OR_OTHER||GMR|0.84|||||TWO_SIDED|90.0|0.35|2.01|||||Mild HI/Healthy Matched to Mild HI|Day 1||2.01|0.35|
71680643|NCT01390428|142879434|SUPERIORITY_OR_OTHER||GMR|1.37|||||TWO_SIDED|90.0|0.83|2.27|||||Mild HI/Healthy Matched to Mild HI|Day 10||2.27|0.83|
71853734|NCT00985621|143221670|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.27||0.018|TWO_SIDED|95.0|-1.16|-0.11|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.11|-1.16|0.018
71853735|NCT00985621|143221670|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.28||0.7|TWO_SIDED|95.0|-0.43|0.65|||ANCOVA|||Analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.65|-0.43|0.700
71853736|NCT00985621|143221671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.24||0.177|TWO_SIDED|95.0|-0.78|0.14|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.14|-0.78|0.177
71853737|NCT00985621|143221671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.24||0.416|TWO_SIDED|95.0|-0.66|0.28|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.28|-0.66|0.416
71853738|NCT00985621|143221671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.5|-0.46|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.46|-1.50|<0.001
71853739|NCT00985621|143221671|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.48|-0.43|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.43|-1.48|<0.001
71853740|NCT00985621|143221672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.23||0.319|TWO_SIDED|95.0|-0.69|0.22|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.22|-0.69|0.319
71853741|NCT00985621|143221672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.23||0.916|TWO_SIDED|95.0|-0.43|0.48|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.48|-0.43|0.916
71853742|NCT00985621|143221672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.24||0.526|TWO_SIDED|95.0|-0.63|0.32|||ANCOVA|||Change at Week 2: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.32|-0.63|0.526
71904281|NCT02387372|143330235|OTHER||Geometric least squares mean ratio (GMR)|1.38|||||TWO_SIDED|90.0|1.21|1.56|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.56|1.21|
71853743|NCT00985621|143221672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.26||0.004|TWO_SIDED|95.0|-1.26|-0.24|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||-0.24|-1.26|0.004
71853744|NCT00985621|143221672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.26||0.134|TWO_SIDED|95.0|-0.9|0.12|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.12|-0.90|0.134
71853745|NCT00985621|143221672|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.27||0.497|TWO_SIDED|95.0|-0.71|0.35|||ANCOVA|||Change at Week 4: analysis was performed using ANCOVA model with treatment as main effect, baseline value, index joint, previous opioid use as covariates, and study site as a random effect.||0.35|-0.71|0.497
71853746|NCT00676663|143221748|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.06|TWO_SIDED|95.0|0.49|1.09|||Log Rank|P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.||||1.09|0.49|0.06
71853747|NCT00676663|143221752|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.018|TWO_SIDED|95.0|0.36|0.97||P-value is stratified by the randomization stratification factors and is 1-sided.|Log Rank||Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.|||0.97|0.36|0.018
71853748|NCT00580047|143221754|OTHER||||||||||||||||||The intervention groups were compared for compliance to either having annual IV zoledronic acid, taking weekly oral alendronate, and taking calcium/vitamin D supplementation.|||
71853749|NCT00546884|143221760|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.16|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71853750|NCT04382053|143221761|SUPERIORITY||Least squares mean difference|0.11|STANDARD_ERROR_OF_MEAN|1.297||0.467|TWO_SIDED|90.0|-2.0|2.3|||ANCOVA|||||2.3|-2.0|0.467
71853751|NCT04382053|143221762|SUPERIORITY|||||||0.237||||||One-sided|Mixed Models Analysis|p-value reported is for the treatment factor across all time points||||||0.237
71680644|NCT01390428|142879434|SUPERIORITY_OR_OTHER||GMR|7.64|||||TWO_SIDED|90.0|2.74|21.27|||||Moderate HI/Healthy Matched to Moderate HI|Day 1||21.27|2.74|
71853752|NCT00924833|143221766|SUPERIORITY_OR_OTHER|||||||0.01||||||"Within subjects effects. Time: P \< 0.01. Time \* treatment: P=0.25~Bonferroni correction. Within the placebo, carvedilol and nebivolol group, p \< 0.01 for Time 3 - Time 1, and Time 3 - Time 2."|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.01
71853753|NCT00924833|143221767|SUPERIORITY_OR_OTHER||||||<|0.05||||||P \< 0.05. Bonferroni correction: p \< 0.05 nebivolol versus carvedilol|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
71853754|NCT00924833|143221768|SUPERIORITY_OR_OTHER|||||||0.93||||||Within subjects effects. Time: p = 0.03. Time \* treatment: p = 0.12.|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student's t-test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."||||0.93
71853755|NCT00924833|143221771|SUPERIORITY_OR_OTHER||||||<|0.05||||||ANOVA with unpaired Student's t-test, Bonferroni correction. Bonferroni correction. p = 0.05.|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.||||<0.05
71822018|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.6|-0.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.2|-0.6|<0.001
71853756|NCT03247985|143221775|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Comparison between groups for bilateral operative time.||||0.17
71853757|NCT03247985|143221775|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||Comparison between groups for unilateral operative time.||||0.09
71853758|NCT03247985|143221778|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||A p-value of 0.05 was considered statistically significant.||||0.02
71853759|NCT00417989|143221780|NON_INFERIORITY_OR_EQUIVALENCE|Superiority test with margin of 0.35|Mean Difference (Final Values)|0.35|STANDARD_DEVIATION|1.2||0.05|TWO_SIDED|95.0|0.24|0.46||Confidence Interval 95%|ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)||Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.||0.46|0.24|0.05
71853760|NCT00417989|143221782|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_DEVIATION|2.0||0.84|TWO_SIDED|95.0|0.64|2.41|||Mantel Haenszel|||||2.41|0.64|0.84
71853761|NCT00417989|143221783|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
71853762|NCT00417989|143221784|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05||95.0|||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC||||||0.05
71853763|NCT00417989|143221785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_DEVIATION|16.0|<|0.001||95.0|-9.76|-3.273|||ANCOVA|||||-3.273|-9.760|< 0.001
71853764|NCT00417989|143221787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.75|||||||||Mean difference|||||||
71853765|NCT00417989|143221788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|STANDARD_DEVIATION|25.53|||TWO_SIDED||||||Mean Difference|||||||
71853766|NCT01245699|143221790|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71853767|NCT01245699|143221791|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71853768|NCT01245699|143221792|SUPERIORITY|||||||0.1|||||||Kruskal-Wallis|||||||0.1
71853769|NCT01245699|143221793|SUPERIORITY|||||||0.65|||||||Kruskal-Wallis|||||||0.65
71853770|NCT00390806|143221795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.1862|TWO_SIDED|95.0|0.73|1.07||p-value from a stratified log-rank test is adjusted for Recursive Partitioning Analysis (RPA) class and the number of brain lesions at Screening.|Log Rank||The hazard ratio is estimated using a Pike estimator. The hazard ratio from a stratified log-rank test is adjusted for RPA class and the number of brain lesions at Screening.|||1.07|0.73|0.1862
71853771|NCT01436045|143221831|SUPERIORITY_OR_OTHER||Percent Change|-15.7|STANDARD_ERROR_OF_MEAN|7.0|<|0.05|TWO_SIDED|||||RBANS Line Orientation|t-test, 2 sided||Response to intranasal Insulin Glulisine \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%|Response to intranasal Insulin Gluiline \[(result post-insulin - result post-placebo)/(result post-placebo)\] x 100%||||<0.05
71853772|NCT01436045|143221834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26|<|0.05|TWO_SIDED||||||t-test, 2 sided|||Difference in errors \[result post-insulin - result post-placebo\]||||<0.05
71853773|NCT03327051|143221843|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.||||||0.04|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||0.04
71853774|NCT03327051|143221843|OTHER|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p\<0.05.|||||>|0.99|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.||||>0.99
71853775|NCT00694564|143221857|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation was calculated as this was a pilot study to determine such parameters.||||||0.004||95.0|||||MANOVA|||||||0.004
71853776|NCT01284634|143221859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89|STANDARD_ERROR_OF_MEAN|5.454||0.222|TWO_SIDED|90.0|-16.35|2.56|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||2.56|-16.35|0.222
71853777|NCT01284634|143221859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.35|STANDARD_ERROR_OF_MEAN|5.943||0.133|TWO_SIDED|90.0|-19.66|0.95|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||0.95|-19.66|0.133
71853778|NCT01284634|143221859|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|STANDARD_ERROR_OF_MEAN|6.158||0.302|TWO_SIDED|90.0|-17.22|4.14|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.||4.14|-17.22|0.302
71853779|NCT02720081|143221873|SUPERIORITY||Difference in least squares means|-4.775||||0.352|TWO_SIDED|95.0|-14.92|5.37|||ANOVA|Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||5.370|-14.92|0.352
71853780|NCT02720081|143221874|OTHER||Difference in percentages|-0.4|||||TWO_SIDED|95.0|-15.0|14.3|||||Based on Miettinen \& Nurminen|||14.3|-15.0|
71853781|NCT02720081|143221875|OTHER||Difference in percentages|-4.3|||||TWO_SIDED|95.0|-12.1|1.0|||||Based on Miettinen \& Nurminen|||1.0|-12.1|
71904282|NCT02387372|143330235|OTHER||GMR|1.15|||||TWO_SIDED|90.0|1.03|1.29|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.29|1.03|
71822019|NCT02886728|143145998|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.7|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-0.7|<0.001
71853782|NCT02720081|143221897|SUPERIORITY||Difference in least squares means|0.107||||0.023|TWO_SIDED|95.0|0.015|0.199|||Constrained longitudinal data analysis|Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.||||0.199|0.015|0.023
71853783|NCT03334747|143221917|OTHER|||||||0.391|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||0.391
71853784|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853785|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853786|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853787|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853788|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853789|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853790|NCT03334747|143221917|OTHER|||||||1|||||||Fisher Exact|2-sided p-value results from Fisher exact test for each KAE609 treatment group compared to Pooled Coartem||||||1
71853791|NCT02567227|143221926|SUPERIORITY||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.3|||TWO_SIDED|95.0|-3.6|1.54|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.||1.54|-3.60|
71853792|NCT02567227|143221926|SUPERIORITY||Mean Difference (Net)|0.59|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-2.59|3.76||P-values from linear mixed effects models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status|||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.||3.76|-2.59|
71853793|NCT02567227|143221927|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|95.0|-0.49|0.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.||0.20|-0.49|
71853794|NCT02567227|143221928|SUPERIORITY||Mean Difference (Net)|0.83|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|95.0|-2.13|3.79|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.||3.79|-2.13|
71853795|NCT02567227|143221928|SUPERIORITY||Mean Difference (Net)|-1.95|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED||||||||Estimates with standard errors are from linear mixed effect models.|Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.||||
71904283|NCT02387372|143330238|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.5|1.96|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.96|1.50|
71904284|NCT02387372|143330238|OTHER||GMR|1.33|||||TWO_SIDED|90.0|1.14|1.55|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.55|1.14|
71680645|NCT01390428|142879434|SUPERIORITY_OR_OTHER||GMR|5.98|||||TWO_SIDED|90.0|2.84|12.57|||||Moderate HI/Healthy Matched to Moderate HI|Day 10||12.57|2.84|
71853796|NCT02567227|143221929|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.91|0.43|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.||0.43|-0.91|
71853797|NCT02567227|143221929|SUPERIORITY||Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|95.0|-1.16|0.27|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.||0.27|-1.16|
71904285|NCT02387372|143330240|OTHER||Geometric least squares mean ratio (GMR)|1.61|||||TWO_SIDED|90.0|1.44|1.81|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.81|1.44|
71904286|NCT02387372|143330240|OTHER||GMR|1.24|||||TWO_SIDED|90.0|1.11|1.39|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.39|1.11|
71904287|NCT02387372|143330241|OTHER||Geometric least squares mean ratio (GMR)|1.71|||||TWO_SIDED|90.0|1.51|1.95|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.95|1.51|
71904288|NCT02387372|143330241|OTHER||GMR|1.2|||||TWO_SIDED|90.0|1.09|1.33|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose||1.33|1.09|
71904289|NCT02190747|143330318|OTHER|||||||0.1664|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1664
71904290|NCT02190747|143330319|OTHER|||||||0.2335|||||||Cochran-Armitage test of trend|||Week 6: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.2335
71904291|NCT02190747|143330319|OTHER|||||||0.0837|||||||Cochran-Armitage test of trend|||Week 12: Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.0837
71904292|NCT02190747|143330320|OTHER||Least square (LS) mean|-86.35|STANDARD_ERROR_OF_MEAN|220.57||0.6984|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.6984
71853798|NCT02567227|143221930|SUPERIORITY||Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.51|0.19|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.||0.19|-0.51|
71853799|NCT02567227|143221930|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.2|0.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.||0.41|-0.20|
71853800|NCT02567227|143221930|SUPERIORITY||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.53|0.32|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.||0.32|-0.53|
71853801|NCT02567227|143221930|SUPERIORITY||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.27|0.56|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.||0.56|-0.27|
71853802|NCT02567227|143221930|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.48|0.45|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.||0.45|-0.48|
71853803|NCT02567227|143221930|SUPERIORITY||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.4|0.35|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.||0.35|-0.40|
71853804|NCT02567227|143221931|SUPERIORITY||Odds Ratio (OR)|0.925|||||TWO_SIDED|95.0|0.369|2.319||||||Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||2.319|0.369|
71904293|NCT02190747|143330320|OTHER||LS mean|-38.07|STANDARD_ERROR_OF_MEAN|252.192||0.8811|TWO_SIDED||||||Pairwise test|||Week 6: Analysis of area of new HO||||0.8811
71904294|NCT02190747|143330320|OTHER||LS mean|-764.38|STANDARD_ERROR_OF_MEAN|220.57||0.0017|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0017
71904295|NCT02190747|143330320|OTHER||LS mean|-703.43|STANDARD_ERROR_OF_MEAN|252.192||0.0094|TWO_SIDED||||||Pairwise test|||Week 12: Analysis of area of new HO||||0.0094
71904296|NCT02190747|143330321|OTHER|||||||0.1503|||||||Cochran-Armitage test of trend|||Cochran-Armitage test of trend (one-sided). The Cochran-Armitage test of trend assessed the overall trend of response across the dose groups (from the lowest dose \[or placebo\], to the highest dose).||||0.1503
71904297|NCT03709810|143330342|SUPERIORITY||Geometric Mean Ratio|0.19|||<|0.0001|TWO_SIDED|95.0|0.12|0.3|||ANOVA|Log10 peanuts mass as response variable, study product and period as fixed explanatory effects, and participant as a random effect.|GMR=(Experimental denture adhesive/ No Adhesive)|||0.30|0.12|<0.0001
71921893|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-16.0|8.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 predose AM||8.4|-16.0|
71921894|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.0|STANDARD_ERROR_OF_MEAN|5.8|||TWO_SIDED|95.0|-15.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||9.1|-15.1|
71921895|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-6.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-17.6|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 1 hour||4.8|-17.6|
71921896|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-9.5|STANDARD_ERROR_OF_MEAN|6.4|||TWO_SIDED|95.0|-22.7|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||3.7|-22.7|
71904298|NCT04866303|143330347|OTHER|unadjusted logistic regression model|Odds Ratio (OR)|1.79||||0.04|TWO_SIDED|95.0|1.03|2.8|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate.||2.80|1.03|0.04
71904299|NCT04866303|143330348|OTHER||Odds Ratio (OR)|1.39||||0.18|TWO_SIDED|95.0|0.86|2.26|||Regression, Logistic|||Minimum testing kit completion rate of 70% in the passive study arm, and calculated that 400 total subjects would provide us with 90% power to detect an effect size associated with a rate ratio of 1.20, or an absolute difference of 14% (70% in passive, 84% in active). A futility boundary of 60% was identified by Community Advisory Board members as justification to prematurely halt trial enrollment if, after completing 25% of expected enrollment, successful test completion fell below that rate||2.26|0.86|0.18
71904300|NCT04124536|143330365|SUPERIORITY||Risk Difference (RD)|-21.9|||||TWO_SIDED|95.0|-35.9|-7.9|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-7.9|-35.9|
71904301|NCT04124536|143330365|SUPERIORITY||Risk Difference (RD)|-30.7|||||TWO_SIDED|95.0|-40.6|-20.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||-20.8|-40.6|
71904302|NCT04124536|143330366|SUPERIORITY||Risk Difference (RD)|-5.4|||||TWO_SIDED|95.0|-13.6|2.8|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||2.8|-13.6|
71904303|NCT04124536|143330366|SUPERIORITY||||||||||||||||||The calculation of risk differences between study arms was originally planned. However, the linear-binomial model did not converge because of zero events in the intervention arm.|||
71680646|NCT01390428|142879434|SUPERIORITY_OR_OTHER||GMR|15.18|||||TWO_SIDED|90.0|6.02|38.25|||||Severe HI/Healthy Matched to Severe HI|Day 1||38.25|6.02|
71904304|NCT04124536|143330370|SUPERIORITY||Risk Difference (RD)|40.7|||||TWO_SIDED|95.0|23.0|58.4|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||58.4|23.0|
71904305|NCT04124536|143330370|SUPERIORITY||Risk Difference (RD)|23.3|||||TWO_SIDED|95.0|10.7|36.0|||||The risk difference was calculated by subtracting the proportion of women meeting the outcome in the intervention arm minus the proportion of women meeting the outcome in the control arm|||36.0|10.7|
71904306|NCT00677690|143330381|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||"All data were expressed as the mean ± SD. The level of significance for all tests was set at p \< 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables."||||< 0.05
71904307|NCT00677690|143330382|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
71904308|NCT00677690|143330383|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
71904309|NCT00677690|143330384|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
71904310|NCT00677690|143330385|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
71904311|NCT02512068|143330430|SUPERIORITY||Least square (LS) mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.124|<|0.0001|TWO_SIDED|95.0|-0.966|-0.473|||ANCOVA|||||-0.473|-0.966|<0.0001
71680647|NCT01390428|142879434|SUPERIORITY_OR_OTHER||GMR|13.01|||||TWO_SIDED|90.0|6.0|28.21|||||Severe HI/Healthy Matched to Severe HI|Day 10||28.21|6.00|
71680648|NCT01390428|142879436|SUPERIORITY_OR_OTHER||GMR|1.86|||||TWO_SIDED|90.0|1.54|2.24|||||Mild HI/Healthy Matched to Mild HI|||2.24|1.54|
71680649|NCT01390428|142879436|SUPERIORITY_OR_OTHER||GMR|2.99|||||TWO_SIDED|90.0|1.31|6.82|||||Moderate HI/Healthy Matched to Moderate HI|||6.82|1.31|
71904312|NCT02512068|143330433|OTHER||Point estimate|-0.28|||||TWO_SIDED|95.0|-0.385|-0.18||||||Change from baseline in HbA1c at Week 2 was compared between the treatment groups.||-0.180|-0.385|
71904313|NCT02512068|143330433|OTHER||Point estimate|-0.48|||||TWO_SIDED|95.0|-0.621|-0.338||||||Change from baseline in HbA1c at Week 4 was compared between the treatment groups.||-0.338|-0.621|
71904314|NCT02512068|143330433|OTHER||Point estimate|-0.58|||||TWO_SIDED|95.0|-0.797|-0.367||||||Change from baseline in HbA1c at Week 8 was compared between the treatment groups.||-0.367|-0.797|
71904315|NCT02512068|143330433|OTHER||Point estimate|-0.71|||||TWO_SIDED|95.0|-0.975|-0.441||||||Change from baseline in HbA1c at Week 12 was compared between the treatment groups.||-0.441|-0.975|
71904316|NCT02512068|143330433|OTHER||Point estimate|-0.7|||||TWO_SIDED|95.0|-0.948|-0.452||||||Change from baseline in HbA1c at End of Treatment Period I was compared between the treatment groups.||-0.452|-0.948|
71904317|NCT02512068|143330434|OTHER||Point estimate|1.7|||||TWO_SIDED|95.0|-6.598|9.919||||||The data of participants achieving \<6.0% at the end of Treatment Period I were compared between the treatment groups.||9.919|-6.598|
71904318|NCT02512068|143330434|OTHER||Point estimate|32.9|||||TWO_SIDED|95.0|14.194|51.66||||||The data of participants achieving \<7.0% at the end of Treatment Period I were compared between the treatment groups.||51.660|14.194|
71904319|NCT02512068|143330434|OTHER||Point estimate|45.6|||||TWO_SIDED|95.0|15.528|75.7||||||The data of participants achieving \<8.0% at the end of Treatment Period I were compared between the treatment groups.||75.700|15.528|
71904320|NCT02512068|143330435|OTHER||Point estimate|-15.2|||||TWO_SIDED|95.0|-23.59|-6.88||||||Change from baseline in fasting plasma glucose at Week 2 was compared between the treatment groups.||-6.88|-23.59|
71904321|NCT02512068|143330435|OTHER||Point estimate|-8.7|||||TWO_SIDED|95.0|-20.98|3.58||||||Change from baseline in fasting plasma glucose at Week 4 was compared between the treatment groups.||3.58|-20.98|
71904322|NCT02512068|143330435|OTHER||Point estimate|-8.3|||||TWO_SIDED|95.0|-18.76|2.11||||||Change from baseline in fasting plasma glucose at Week 8 was compared between the treatment groups.||2.11|-18.76|
71904323|NCT02512068|143330435|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-27.14|-4.03||||||Change from baseline in fasting plasma glucose at Week 12 was compared between the treatment groups.||-4.03|-27.14|
71904324|NCT02512068|143330435|OTHER||Point estimate|-15.6|||||TWO_SIDED|95.0|-26.67|-4.62||||||Change from baseline in fasting plasma glucose at End of Treatment Period I was compared between the treatment groups.||-4.62|-26.67|
71822020|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|13.1|24.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||24.4|13.1|<0.001
71822021|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|11.7|||<|0.001|TWO_SIDED|95.0|4.7|18.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||18.6|4.7|<0.001
71822022|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|19.9|||<|0.001|TWO_SIDED|95.0|12.5|27.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||27.3|12.5|<0.001
71822023|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|27.2|||<|0.001|TWO_SIDED|95.0|20.5|33.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||33.9|20.5|<0.001
71822024|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|21.6|||<|0.001|TWO_SIDED|95.0|13.2|30.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||30.1|13.2|<0.001
71822025|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|19.5|||<|0.001|TWO_SIDED|95.0|11.1|27.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||27.9|11.1|<0.001
71822026|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|15.8|29.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24||29.4|15.8|<0.001
71822027|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|16.6|||<|0.001|TWO_SIDED|95.0|8.1|25.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24||25.2|8.1|<0.001
71904325|NCT02512068|143330436|OTHER||Point estimate|-1.76|||||TWO_SIDED|95.0|-2.184|-1.34||||||Change from baseline in glycoalbumin at Week 2 was compared between the treatment groups.||-1.340|-2.184|
71904326|NCT02512068|143330436|OTHER||Point estimate|-2.45||||||95.0|-3.03|-1.87||||||Change from baseline in glycoalbumin at Week 4 was compared between the treatment groups.||-1.870|-3.030|
71680650|NCT01390428|142879438|SUPERIORITY_OR_OTHER||GMR|1.92|||||TWO_SIDED|90.0|1.4|2.63|||||Mild HI/Healthy Matched to Mild HI|||2.63|1.40|
71680651|NCT01390428|142879438|SUPERIORITY_OR_OTHER||GMR|3.59|||||TWO_SIDED|90.0|1.81|7.11|||||Moderate HI/Healthy Matched to Moderate HI|||7.11|1.81|
71822028|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|13.8|||<|0.001|TWO_SIDED|95.0|5.3|22.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24||22.4|5.3|<0.001
71822029|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|21.4|||<|0.001|TWO_SIDED|95.0|14.6|28.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.2|14.6|<0.001
71822030|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|12.3||||0.003|TWO_SIDED|95.0|3.7|20.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.9|3.7|0.003
71822031|NCT02886728|143145999|SUPERIORITY||Difference in Response Rates|18.1|||<|0.001|TWO_SIDED|95.0|9.7|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||26.5|9.7|<0.001
71822032|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|6.3|||<|0.001|TWO_SIDED|95.0|3.4|9.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2||9.1|3.4|<0.001
71822033|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|3.4||||0.01|TWO_SIDED|95.0|0.1|6.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2||6.7|0.1|0.010
71822034|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|9.0|||<|0.001|TWO_SIDED|95.0|4.5|13.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2||13.6|4.5|<0.001
71822035|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|11.8|||<|0.001|TWO_SIDED|95.0|7.4|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4||16.1|7.4|<0.001
71822036|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.5|15.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4||15.8|4.5|<0.001
71822037|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|8.6|20.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4||20.8|8.6|<0.001
71822038|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|22.6|||<|0.001|TWO_SIDED|95.0|16.4|28.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12||28.8|16.4|<0.001
71904327|NCT02512068|143330436|OTHER||Point estimate|-2.48|||||TWO_SIDED|95.0|-3.289|-1.679||||||Change from baseline in glycoalbumin at Week 8 was compared between the treatment groups.||-1.679|-3.289|
71904328|NCT02512068|143330436|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at Week 12 was compared between the treatment groups.||-1.715|-3.608|
71680652|NCT01390428|142879438|SUPERIORITY_OR_OTHER||GMR|9.34|||||TWO_SIDED|90.0|4.98|17.51|||||Severe HI/Healthy Matched to Severe HI|||17.51|4.98|
71822039|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|14.8|||<|0.001|TWO_SIDED|95.0|7.1|22.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12||22.5|7.1|<0.001
71822040|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|12.5|||<|0.001|TWO_SIDED|95.0|4.9|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12||20.0|4.9|<0.001
71853805|NCT02567227|143221931|SUPERIORITY||Odds Ratio (OR)|0.961|||||TWO_SIDED|95.0|0.516|1.789||||||Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).||1.789|0.516|
71853806|NCT02567227|143221932|SUPERIORITY||Mean Difference (Net)|-7.52|STANDARD_ERROR_OF_MEAN|14.17|||TWO_SIDED|95.0|-35.45|20.41|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.||20.41|-35.45|
71904329|NCT02512068|143330436|OTHER||Point estimate|-2.66|||||TWO_SIDED|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at End of Treatment Period I was compared between the treatment groups.||-1.715|-3.608|
71853807|NCT02567227|143221933|SUPERIORITY||Mean Difference (Net)|1.01|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-0.3|2.31|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.||2.31|-0.30|
71853808|NCT02567227|143221934|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.||||
71853809|NCT02567227|143221935|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.07|0.06|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.||0.06|-0.07|
71904330|NCT01962714|143330450|NON_INFERIORITY|The primary outcome of non-inferiority of LKM relative to CPT-C was assessed using a non-inferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD symptoms based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a large sample (N=198) of treatment-seeking veterans.|Mean Difference (Final Values)|2.09|||||TWO_SIDED|95.0|-2.59|6.78|||||Non-inferiority of LKM to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||6.78|-2.59|
71904331|NCT01962714|143330451|NON_INFERIORITY|For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen's d effect size of approximately 0.50.|Mean Difference (Final Values)|2.34|||||TWO_SIDED|95.0|-0.52|5.2|||||Non-inferiority of LKM with respect to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.||5.20|-0.52|
71904332|NCT01151579|143330452|NON_INFERIORITY_OR_EQUIVALENCE|A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.5||0.01|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.||||0.01
71904333|NCT01151579|143330453|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.05|TWO_SIDED|95.0||||Analysis adjusted with Fischer exact chi-square for rare occurrences.|Chi-squared|||Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.||||0.05
71904334|NCT01151579|143330454|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||descriptive|Descriptive statistics (frequency) used to report the number of participants experiencing an event.||To report on the number of events.||||0
71904335|NCT02458690|143330455|SUPERIORITY|||||||0.6|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.60
71904336|NCT02458690|143330456|SUPERIORITY||||||<|0.01|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||<0.01
71904337|NCT02458690|143330457|SUPERIORITY|||||||0.81|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.81
71853810|NCT02567227|143221936|SUPERIORITY||Mean Difference (Net)|0.67|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.86|2.2|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.||2.20|-0.86|
71904338|NCT02458690|143330458|SUPERIORITY|||||||0.2|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.20
71904339|NCT02458690|143330459|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
71904340|NCT02458690|143330460|SUPERIORITY|||||||0.23|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.23
71904341|NCT02458690|143330461|SUPERIORITY|||||||0.09|||||||ANCOVA|ANCOVA models adjusted for the stratification variables of age group and sex||||||0.09
71904342|NCT03615469|143330462|OTHER|t-test||||||0.22|||||||t-test, 2 sided|||||||0.22
71904343|NCT01153763|143330463|OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|48.2|70.3|||||The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.|||70.3|48.2|
71904344|NCT01153763|143330464|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|0.0|28.7|||||The estimated value represents the percentage of participants with a investigator assessed CR or PR.|||28.7|0.0|
71904345|NCT01153763|143330469|OTHER||percentage of participants|20.0|||||TWO_SIDED|95.0|11.6|29.8|||||The estimated value represents the percentage of participants with overall survival.|||29.8|11.6|
71904346|NCT01153763|143330470|OTHER||percentage of participants|13.0|||||TWO_SIDED|95.0|2.2|34.6|||||The estimated value represents the percentage of participants with overall survival.|||34.6|2.2|
71904347|NCT04570657|143330545|SUPERIORITY||LS mean difference|0.036||||0.267|TWO_SIDED|80.0|-0.038|0.111||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.111|-0.038|0.267
71904348|NCT04570657|143330545|SUPERIORITY||LS mean difference|0.004||||0.473|TWO_SIDED|80.0|-0.071|0.079||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.079|-0.071|0.473
71904349|NCT04570657|143330546|SUPERIORITY||LS mean difference|-0.012||||0.437|TWO_SIDED|80.0|-0.11|0.086||One-sided p-value|MMRM||Week 8: Tozorakimab Dose A - Placebo|||0.086|-0.110|0.437
71904350|NCT04570657|143330546|SUPERIORITY||LS mean difference|0.059||||0.221|TWO_SIDED|80.0|-0.039|0.157||One-sided p-value|MMRM||Week 8: Tozorakimab Dose B - Placebo|||0.157|-0.039|0.221
71904351|NCT04570657|143330546|SUPERIORITY||LS mean difference|-0.038||||0.308|TWO_SIDED|80.0|-0.136|0.06||One-sided p-value|MMRM||Week 16: Tozorakimab Dose A - Placebo|||0.060|-0.136|0.308
71904352|NCT04570657|143330546|SUPERIORITY||LS mean difference|-0.025||||0.372|TWO_SIDED|80.0|-0.122|0.072||One-sided p-value|MMRM||Week 16: Tozorakimab Dose B - Placebo|||0.072|-0.122|0.372
71904353|NCT04570657|143330549|SUPERIORITY||LS mean difference|-0.03||||0.416|TWO_SIDED|80.0|-0.215|0.154||One-sided p-value|MMRM||Tozorakimab Dose A - Placebo|||0.154|-0.215|0.416
71904354|NCT04570657|143330549|SUPERIORITY||LS mean difference|-0.047||||0.371|TWO_SIDED|80.0|-0.231|0.137||One-sided p-value|MMRM||Tozorakimab Dose B - Placebo|||0.137|-0.231|0.371
71904355|NCT04570657|143330550|SUPERIORITY||Odds Ratio (OR)|1.2||||0.612|TWO_SIDED|80.0|0.76|1.9|||Chi-squared|||||1.90|0.76|0.612
71904356|NCT04570657|143330550|SUPERIORITY||Odds Ratio (OR)|1.41||||0.348|TWO_SIDED|80.0|0.88|2.25|||Chi-squared|||||2.25|0.88|0.348
71904357|NCT04570657|143330551|SUPERIORITY||Odds Ratio (OR)|0.81||||0.575|TWO_SIDED|80.0|0.5|1.31|||Chi-squared|||||1.31|0.50|0.575
71904358|NCT04570657|143330551|SUPERIORITY||Odds Ratio (OR)|0.86||||0.679|TWO_SIDED|80.0|0.53|1.38|||Chi-squared|||||1.38|0.53|0.679
71904359|NCT04570657|143330552|SUPERIORITY||LS mean difference|0.002||||0.5|TWO_SIDED|80.0|-3.825|3.828||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose A - Placebo|||3.828|-3.825|0.500
71904360|NCT04570657|143330552|SUPERIORITY||LS mean difference|-1.364||||0.324|TWO_SIDED|80.0|-5.198|2.47||One-sided p-value|MMRM||SGRQ Activity Total Score: Tozorakimab Dose B - Placebo|||2.470|-5.198|0.324
71904361|NCT04570657|143330552|SUPERIORITY||LS mean difference|-1.421||||0.248|TWO_SIDED|80.0|-4.103|1.26||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose A - Placebo|||1.260|-4.103|0.248
71904362|NCT04570657|143330552|SUPERIORITY||LS mean difference|-1.694||||0.21|TWO_SIDED|80.0|-4.383|0.996||One-sided p-value|MMRM||SGRQ Impacts Total Score: Tozorakimab Dose B - Placebo|||0.996|-4.383|0.210
71904363|NCT04570657|143330552|SUPERIORITY||LS mean difference|0.691||||0.42|TWO_SIDED|80.0|-3.715|5.096||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose A - Placebo|||5.096|-3.715|0.420
71904364|NCT04570657|143330552|SUPERIORITY||LS mean difference|-3.15||||0.181|TWO_SIDED|80.0|-7.579|1.28||One-sided p-value|MMRM||SGRQ Symptoms Total Score: Tozorakimab Dose B - Placebo|||1.280|-7.579|0.181
71904365|NCT04570657|143330552|SUPERIORITY||LS mean difference|-0.663||||0.38|TWO_SIDED|80.0|-3.454|2.129||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose A - Placebo|||2.129|-3.454|0.380
71904366|NCT04570657|143330552|SUPERIORITY||LS mean difference|-1.896||||0.192|TWO_SIDED|80.0|-4.694|0.903||One-sided p-value|MMRM||SGRQ Total Score: Tozorakimab Dose B - Placebo|||0.903|-4.694|0.192
71904367|NCT04570657|143330553|SUPERIORITY||Odds Ratio (OR)|0.93||||0.828|TWO_SIDED|80.0|0.59|1.46|||Chi-squared|||||1.46|0.59|0.828
71904368|NCT04570657|143330553|SUPERIORITY||Odds Ratio (OR)|1.07||||0.84|TWO_SIDED|80.0|0.68|1.7|||Chi-squared|||||1.70|0.68|0.840
71904369|NCT04570657|143330554|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.239|TWO_SIDED|80.0|0.8|2.0||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||2.0|0.8|0.239
71904370|NCT04570657|143330554|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.461|TWO_SIDED|80.0|0.6|1.7||One-sided p-value|Regression, Cox|Cox regression model with treatment group, background medication, geographic region, and ICS total daily dose as covariates.||||1.7|0.6|0.461
71904371|NCT04570657|143330555|SUPERIORITY||Rate ratio|0.87||||0.346|TWO_SIDED|80.0|0.56|1.36||One-sided p-value|Negative binomial regression|||||1.36|0.56|0.346
71904372|NCT04570657|143330555|SUPERIORITY||Rate ratio|0.7||||0.166|TWO_SIDED|80.0|0.43|1.12||One-sided p-value|Negative binomial regression|||||1.12|0.43|0.166
71904373|NCT04570657|143330556|SUPERIORITY||Geometric LS mean ratio|0.869||||0.029|TWO_SIDED|80.0|0.791|0.956||One-sided p-value|MMRM|||||0.956|0.791|0.029
71904374|NCT04570657|143330556|SUPERIORITY||Geometric LS mean ratio|0.879||||0.04|TWO_SIDED|80.0|0.8|0.966||One-sided p-value|MMRM|||||0.966|0.800|0.040
71904375|NCT04570657|143330557|SUPERIORITY||LS mean difference|0.023||||0.385|TWO_SIDED|80.0|-0.078|0.124||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|1 Exacerbation in Last 12 Months||0.124|-0.078|0.385
71904376|NCT04570657|143330557|SUPERIORITY||LS mean difference|-0.123||||0.06|TWO_SIDED|80.0|-0.224|-0.022||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|1 Exacerbation in Last 12 Months||-0.022|-0.224|0.060
71904377|NCT04570657|143330557|SUPERIORITY||LS mean Difference|0.077||||0.186|TWO_SIDED|80.0|-0.034|0.187||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose A - Placebo|≥ 2 Exacerbation in Last 12 Months||0.187|-0.034|0.186
71904378|NCT04570657|143330557|SUPERIORITY||LS mean difference|0.212||||0.007|TWO_SIDED|80.0|0.102|0.322||One-sided p-value; alpha = 0.1|MMRM||Tozorakimab Dose B - Placebo|≥ 2 Exacerbation in Last 12 Months||0.322|0.102|0.007
71904379|NCT04570657|143330558|SUPERIORITY||Geometric LS Mean Ratio|0.63|||<|0.001|TWO_SIDED|80.0|0.559|0.71||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.710|0.559|< 0.001
71904380|NCT04570657|143330558|SUPERIORITY||Geometric LS Mean Ratio|0.675|||<|0.001|TWO_SIDED|80.0|0.599|0.76||One-sided p-value|MMRM|||Analysis at Week 16 based on MMRM which included fixed effects for baseline, background medication, geographic region, baseline ICS total daily dose, visit, treatment and the baseline by visit and treatment by visit interactions.||0.760|0.599|< 0.001
71904381|NCT01072539|143330561|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||<0.0001
71904382|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||||||Statistical significant level: 0.05|Chi-squared|||Geriatrc: \<65 Years Versus (VS) Geriatrc: \>=65 Years||||0.0067
71904383|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0412||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age categories: \<30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and \>=65 Years.||||0.0412
71904384|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4792||||||Statistical significant level: 0.05|Chi-squared|||Sex: Male VS Sex: Female||||0.4792
71904385|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9669||||||Statistical significant level: 0.05|Chi-squared|||Comparson among Duration of Disease categories: \<3 Months, \>=3 Months and \<6 Months, and \>=6 Months||||0.9669
71904386|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0064||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.||||0.0064
71904387|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Satistical significant level: 0.05|Chi-squared|||Comparison among severity of infection subgroups: Mild, Moderate, and Severe.||||<0.0001
71904388|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History: Yes VS General Medical History: No||||<0.0001
71904389|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Present): Yes VS General Medical History (Present): No||||<0.0001
71904390|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Past): Yes VS General Medical History (Past): No||||0.0006
71904391|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Kidney Disorder: Yes VS Kidney Disorder: No||||<0.0001
71904392|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Liver Disorder: Yes VS Liver Disorder: No||||<0.0001
71904393|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0153||||||Statistical significant level: 0.05|Chi-squared|||Comparison among subgroups of Total Treatment Period of Tygacil: \<7 Days, 7 to 14 Days, and \>14 Days||||0.0153
71904394|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level 0.05|Fisher Exact|||Comparison among subgroups of Mean Daily Dose of Tygacil: \<50 mg, 50 to \<100 mg, 100 to \<200 mg, and \>=200 mg.||||<0.0001
71904395|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0376||||||Statistical significant level: 0.05|Chi-squared|||Past Medication and Therapy: Yes VS Past Medication and Therapy: No||||0.0376
71904396|NCT01072539|143330562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Concomitant Medications: Yes VS Concomitant Medications: No||||<0.0001
71904397|NCT02856269|143330564|OTHER|Wilcoxon rank sum tests, X2 tests, Fisher exact tests, Kolmogorov-Smirnov|Cohen's D value|0.8|||||TWO_SIDED||||||||The Cohen's d is calculated after Box-Cox transformation. Small effect \<= 0.2, Medium effect \[0.3, 0.8\]; Large effect \>0.8|||||
71904398|NCT01752842|143330574|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-0.75||||0.07|TWO_SIDED|95.0|-1.56|0.04||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of cardiac diastolic function adjusting for body fat percent, baseline values of BMI, diastolic/systolic blood pressure, HbA1c, fasting glucose, triglycerides, ethnicity, gender and race.|Null hypothesis is no difference of mean change of cardiac diastolic function as measured by E' (cm/s) between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.04|-1.56|0.07
71680653|NCT04281784|142879458|SUPERIORITY||Risk Difference (RD)|0.0421||||0.027|TWO_SIDED|95.0|0.0047|0.0777||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Occurrence of discussion regressed on randomization condition, adjusted for ADRD status, hospital, and time between study start \& randomization date.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.0777|0.0047|0.027
71680654|NCT04281784|142879460|SUPERIORITY||Mean Difference (Final Values)|-0.078|STANDARD_ERROR_OF_MEAN|0.246||0.75|TWO_SIDED|95.0|-0.56|0.404|||Regression, Linear|Outcome (days alive and out of ICU) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.404|-0.560|0.750
71853811|NCT02567227|143221939|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-1.65|3.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.||3.91|-1.65|
71680655|NCT04281784|142879461|SUPERIORITY||Median Difference (Final Values)|-0.361|STANDARD_ERROR_OF_MEAN|0.357||0.312|TWO_SIDED|95.0|-1.06|0.338|||Regression, Linear|Outcome (days alive and out of hospital) regressed on Arm/Group (0=usual care, 1=intervention), adjusted for hospital and ADRD status|Robust (HC3) standard error|Superior outcome for Group 2||0.338|-1.060|0.312
71853812|NCT02567227|143221939|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|-2.12|4.91|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.||4.91|-2.12|
71853813|NCT02567227|143221940|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.||||
71853814|NCT02567227|143221941|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED||||||||Estimates with standard errors are from unadjusted linear mixed effect models.|Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.||||
71853815|NCT02567227|143221942|SUPERIORITY||Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-0.4|0.93|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.||0.93|-0.40|
71853816|NCT02567227|143221944|SUPERIORITY||Mean Difference (Net)|0.39|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-1.38|2.16|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.||2.16|-1.38|
71853817|NCT02567227|143221945|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.64|||TWO_SIDED|95.0|-1.46|1.04|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.||1.04|-1.46|
71853818|NCT02567227|143221945|SUPERIORITY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|95.0|-1.04|1.85|||||Estimates with standard errors are from linear mixed effect models adjusted for age, sex, education years, comorbidities, pain, cardiac fitness, and cognitive status.|Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.||1.85|-1.04|
71853819|NCT04748445|143221951|OTHER||Slope|0.065|||<|0.0001|TWO_SIDED|90.0|0.046|0.083|||Mixed Models Analysis|||Chills||0.083|0.046|<.0001
71853820|NCT04748445|143221951|OTHER||Slope|0.281|||<|0.0001|TWO_SIDED|90.0|0.221|0.341|||Mixed Models Analysis|||Cough||0.341|0.221|<.0001
71853821|NCT04748445|143221951|OTHER||Slope|0.036|||<|0.0001|TWO_SIDED|90.0|0.023|0.048|||Mixed Models Analysis|||Diarrhea||0.048|0.023|<.0001
71904399|NCT01752842|143330575|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|0.0058||||0.8128|TWO_SIDED|95.0|-0.0418|0.0543||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.|Null hypothesis is no difference of mean change of fractional shortening percent between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|0.0543|-0.0418|0.8128
71904400|NCT01752842|143330576|SUPERIORITY|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-1.79||||0.0034|TWO_SIDED|95.0|-2.93|-0.65||This P-value is based on ANCOVA.|ANCOVA|ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.||Null hypothesis is no difference of mean change of C24:0/C16:0 ceramide ratio between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.|-0.65|-2.93|0.0034
71904401|NCT01683071|143330577|SUPERIORITY||LSMD|2.9||||0.9494|TWO_SIDED|95.0|-88.0|94.0|||ANCOVA|||||94|-88|0.9494
71904402|NCT01683071|143330577|SUPERIORITY||LSMD|-103.3||||0.0237|TWO_SIDED|95.0|-192.0|-14.0|||ANCOVA|||||-14|-192|0.0237
71904403|NCT01683071|143330577|SUPERIORITY||LSMD|-94.3||||0.0386|TWO_SIDED|95.0|-184.0|-5.0|||ANCOVA|||||-5|-184|0.0386
71680656|NCT04281784|142879462|SUPERIORITY||Risk Difference (RD)|0.012||||0.475|TWO_SIDED|95.0|-0.02|0.043||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Readmission (0, 1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.043|-0.020|0.475
71853822|NCT04748445|143221951|OTHER||Slope|0.113|||<|0.0001|TWO_SIDED|90.0|0.069|0.156|||Mixed Models Analysis|||Difficulty breathing||0.156|0.069|<.0001
71904404|NCT01683071|143330577|SUPERIORITY||LSMD|-96.5|||<|0.0001|TWO_SIDED|95.0|-144.0|-49.0|||ANCOVA|||||-49|-144|<0.0001
71904405|NCT01683071|143330578|SUPERIORITY||Geometric LSM ratio|0.9||||0.6182|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.6182
71853823|NCT04748445|143221951|OTHER||Slope|0.259|||<|0.0001|TWO_SIDED|90.0|0.206|0.312|||Mixed Models Analysis|||Fatigue||0.312|0.206|<.0001
71853824|NCT04748445|143221951|OTHER||Slope|0.029|||<|0.0001|TWO_SIDED|90.0|0.02|0.037|||Mixed Models Analysis|||Fever||0.037|0.020|<.0001
71853825|NCT04748445|143221951|OTHER||Slope|0.194|||<|0.0001|TWO_SIDED|90.0|0.148|0.241|||Mixed Models Analysis|||Headache||0.241|0.148|<.0001
71853826|NCT04748445|143221951|OTHER||Slope|0.103||||0.0002|TWO_SIDED|90.0|0.059|0.148|||Mixed Models Analysis|||Loss of taste or smell||0.148|0.059|0.0002
71853827|NCT04748445|143221951|OTHER||Slope|0.181|||<|0.0001|TWO_SIDED|90.0|0.137|0.226|||Mixed Models Analysis|||Muscle pain||0.226|0.137|<.0001
71853828|NCT04748445|143221951|OTHER||Slope|0.044|||<|0.0001|TWO_SIDED|90.0|0.028|0.06|||Mixed Models Analysis|||Nausea||0.060|0.028|<.0001
71853829|NCT04748445|143221951|OTHER||Slope|0.03||||0.0007|TWO_SIDED|90.0|0.016|0.044|||Mixed Models Analysis|||Rigors||0.044|0.016|0.0007
71853830|NCT04748445|143221951|OTHER||Slope|0.159|||<|0.0001|TWO_SIDED|90.0|0.123|0.195|||Mixed Models Analysis|||Runny nose||0.195|0.123|<.0001
71853831|NCT04748445|143221951|OTHER||Slope|0.222|||<|0.0001|TWO_SIDED|90.0|0.168|0.277|||Mixed Models Analysis|||Sore throat||0.277|0.168|<.0001
71853832|NCT04748445|143221951|OTHER||Slope|0.337|||<|0.0001|TWO_SIDED|90.0|0.264|0.411|||Mixed Models Analysis|||Stuffy/blocked nose||0.411|0.264|<.0001
71853833|NCT04748445|143221951|OTHER||Slope|0.005||||0.0053|TWO_SIDED|90.0|0.002|0.007|||Mixed Models Analysis|||Vomiting||0.007|0.002|0.0053
71853834|NCT04748445|143221951|OTHER||Slope|0.049||||0.0057|TWO_SIDED|90.0|0.02|0.078|||Mixed Models Analysis|||Wheezing||0.078|0.020|0.0057
71853835|NCT04748445|143221951|OTHER||Slope|2.644|||<|0.0001|TWO_SIDED|90.0|2.101|3.188|||Mixed Models Analysis|||Mean of daily total symptom score||3.188|2.101|<.0001
71904406|NCT01683071|143330578|SUPERIORITY||Geometric LSM ratio|0.73||||0.1097|TWO_SIDED|95.0|0.5|1.1|||ANOVA|||||1.1|0.5|0.1097
71904407|NCT01683071|143330578|SUPERIORITY||Geometric LSM ratio|0.85||||0.4046|TWO_SIDED|95.0|0.6|1.3|||ANOVA|||||1.3|0.6|0.4046
71904408|NCT01683071|143330578|SUPERIORITY||Geometric LSM ratio|0.74||||0.0016|TWO_SIDED|95.0|0.6|0.9|||ANOVA|||||0.9|0.6|0.0016
71904409|NCT02020031|143330581|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
71904410|NCT02020031|143330581|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
71904411|NCT02020031|143330581|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
71904412|NCT02020031|143330581|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
71904413|NCT02020031|143330581|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
71904414|NCT02020031|143330581|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|||Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.||||<0.0001
71904415|NCT04047121|143330583|SUPERIORITY|||||||0.2531|||||||Chi-squared|||||||0.2531
71904416|NCT04047121|143330583|SUPERIORITY|||||||0.0295|||||||Chi-squared|||||||0.0295
71904417|NCT04047121|143330583|SUPERIORITY|||||||0.1857|||||||Chi-squared|||||||0.1857
71904418|NCT04047121|143330583|SUPERIORITY||Odds Ratio (OR)|0.8401||||0.3297|TWO_SIDED|95.0|0.5919|1.1925|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1925|0.5919|0.3297
71904419|NCT04047121|143330583|SUPERIORITY||Odds Ratio (OR)|1.5066||||0.2003|TWO_SIDED|95.0|0.8046|2.8209|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.8209|0.8046|0.2003
71904420|NCT04047121|143330583|SUPERIORITY||Odds Ratio (OR)|1.4052||||0.2276|TWO_SIDED|95.0|0.8086|2.442|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.4420|0.8086|0.2276
71904421|NCT04047121|143330584|SUPERIORITY|||||||0.8786|||||||Chi-squared|||||||0.8786
71904422|NCT04047121|143330584|SUPERIORITY|||||||0.1178|||||||Chi-squared|||||||0.1178
71904423|NCT04047121|143330584|SUPERIORITY|||||||0.5337|||||||Chi-squared|||||||0.5337
71904424|NCT04047121|143330584|SUPERIORITY||Odds Ratio (OR)|1.0283||||0.9212|TWO_SIDED|95.0|0.5911|1.789|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7890|0.5911|0.9212
71904425|NCT04047121|143330584|SUPERIORITY||Odds Ratio (OR)|0.7464||||0.4693|TWO_SIDED|95.0|0.338|1.6482|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6482|0.3380|0.4693
71904426|NCT04047121|143330584|SUPERIORITY||Odds Ratio (OR)|0.8212||||0.5593|TWO_SIDED|95.0|0.4239|1.591|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5910|0.4239|0.5593
71904427|NCT04047121|143330585|SUPERIORITY|||||||0.6205|||||||Chi-squared|||||||0.6205
71904428|NCT04047121|143330585|SUPERIORITY|||||||0.4924|||||||Chi-squared|||||||0.4924
71904429|NCT04047121|143330585|SUPERIORITY|||||||0.4982|||||||Chi-squared|||||||0.4982
71904430|NCT04047121|143330585|SUPERIORITY||Odds Ratio (OR)|1.3182||||0.5494|TWO_SIDED|95.0|0.5335|3.257|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2570|0.5335|0.5494
71904431|NCT04047121|143330585|SUPERIORITY||Odds Ratio (OR)|1.1664||||0.783|TWO_SIDED|95.0|0.39|3.4883|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.4883|0.3900|0.7830
71904432|NCT04047121|143330586|SUPERIORITY|||||||0.3817|||||||Chi-squared|||||||0.3817
71904433|NCT04047121|143330586|SUPERIORITY|||||||0.7397|||||||Chi-squared|||||||0.7397
71904434|NCT04047121|143330586|SUPERIORITY|||||||0.7942|||||||Chi-squared|||||||0.7942
71904435|NCT04047121|143330586|SUPERIORITY||Odds Ratio (OR)|1.0682||||0.7924|TWO_SIDED|95.0|0.6537|1.7455|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7455|0.6537|0.7924
71904436|NCT04047121|143330586|SUPERIORITY||Odds Ratio (OR)|1.0414||||0.9339|TWO_SIDED|95.0|0.3997|2.7134|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7134|0.3997|0.9339
71904437|NCT04047121|143330586|SUPERIORITY||Odds Ratio (OR)|0.8195||||0.6497|TWO_SIDED|95.0|0.347|1.935|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9350|0.3470|0.6497
71904438|NCT04047121|143330587|SUPERIORITY|||||||0.7936|||||||Chi-squared|||||||0.7936
71904439|NCT04047121|143330587|SUPERIORITY|||||||0.5621|||||||Chi-squared|||||||0.5621
71904440|NCT04047121|143330587|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.6800
71904441|NCT04047121|143330587|SUPERIORITY||Odds Ratio (OR)|1.1438||||0.5051|TWO_SIDED|95.0|0.7705|1.6978|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6978|0.7705|0.5051
71904442|NCT04047121|143330587|SUPERIORITY||Odds Ratio (OR)|0.8576||||0.7131|TWO_SIDED|95.0|0.3781|1.9452|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.9452|0.3781|0.7131
71904443|NCT04047121|143330587|SUPERIORITY||Odds Ratio (OR)|0.8415||||0.649|TWO_SIDED|95.0|0.4003|1.769|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7690|0.4003|0.6490
71904444|NCT04047121|143330588|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
71904445|NCT04047121|143330588|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
71904446|NCT04047121|143330588|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
71904447|NCT04047121|143330588|SUPERIORITY||Odds Ratio (OR)|1.1637||||0.5368|TWO_SIDED|95.0|0.7193|1.8827|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.8827|0.7193|0.5368
71904448|NCT04047121|143330588|SUPERIORITY||Odds Ratio (OR)|0.7757||||0.4685|TWO_SIDED|95.0|0.3904|1.5413|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5413|0.3904|0.4685
71904449|NCT04047121|143330588|SUPERIORITY||Odds Ratio (OR)|0.7354||||0.3112|TWO_SIDED|95.0|0.4057|1.333|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.3330|0.4057|0.3112
71904450|NCT04047121|143330589|SUPERIORITY|||||||0.8122|||||||Log Rank|||||||0.8122
71904451|NCT04047121|143330589|SUPERIORITY|||||||0.7766|||||||Log Rank|||||||0.7766
71904452|NCT04047121|143330589|SUPERIORITY|||||||0.8305|||||||Log Rank|||||||0.8305
71904453|NCT04047121|143330589|SUPERIORITY||Hazard Ratio (HR)|0.5814||||0.1845|TWO_SIDED|95.0|0.261|1.2952|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.2952|0.2610|0.1845
71904454|NCT04047121|143330589|SUPERIORITY||Hazard Ratio (HR)|1.5908||||0.2951|TWO_SIDED|95.0|0.6671|3.7936|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.7936|0.6671|0.2951
71904455|NCT04047121|143330589|SUPERIORITY||Hazard Ratio (HR)|1.3546||||0.4907|TWO_SIDED|95.0|0.6584|2.787|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.7870|0.6584|0.4907
71904456|NCT04047121|143330590|SUPERIORITY|||||||0.6006|||||||Log Rank|||||||0.6006
71904457|NCT04047121|143330590|SUPERIORITY|||||||0.2941|||||||Log Rank|||||||0.2941
71904458|NCT04047121|143330590|SUPERIORITY|||||||0.961|||||||Log Rank|||||||0.9610
71904459|NCT04047121|143330590|SUPERIORITY||Hazard Ratio (HR)|0.5571||||0.0455|TWO_SIDED|95.0|0.314|0.9884|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||0.9884|0.3140|0.0455
71904460|NCT04047121|143330590|SUPERIORITY||Hazard Ratio (HR)|2.1781||||0.0274|TWO_SIDED|95.0|1.0904|4.3506|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||4.3506|1.0904|0.0274
71904461|NCT04047121|143330590|SUPERIORITY||Hazard Ratio (HR)|0.8896||||0.6787|TWO_SIDED|95.0|0.5114|1.5475|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5475|0.5114|0.6787
71904462|NCT04047121|143330591|SUPERIORITY|||||||0.9084|||||||Log Rank|||||||0.9084
71904463|NCT04047121|143330591|SUPERIORITY|||||||0.8325|||||||Log Rank|||||||0.8325
71904464|NCT04047121|143330591|SUPERIORITY|||||||0.963|||||||Log Rank|||||||0.9630
71904465|NCT04047121|143330591|SUPERIORITY||Hazard Ratio (HR)|1.0508||||0.7909|TWO_SIDED|95.0|0.7284|1.516|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.5160|0.7284|0.7909
71904466|NCT04047121|143330591|SUPERIORITY||Hazard Ratio (HR)|0.8117||||0.6027|TWO_SIDED|95.0|0.37|1.7808|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.7808|0.3700|0.6027
71904467|NCT04047121|143330591|SUPERIORITY||Hazard Ratio (HR)|1.1742||||0.6978|TWO_SIDED|95.0|0.5222|2.6404|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||2.6404|0.5222|0.6978
71904468|NCT04047121|143330592|SUPERIORITY|||||||0.1736|||||||Log Rank|||||||0.1736
71904469|NCT04047121|143330592|SUPERIORITY|||||||0.0195|||||||Log Rank|||||||0.0195
71904470|NCT04047121|143330592|SUPERIORITY|||||||0.2104|||||||Log Rank|||||||0.2104
71904471|NCT04047121|143330592|SUPERIORITY||Hazard Ratio (HR)|1.1723||||0.167|TWO_SIDED|95.0|0.9357|1.4687|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.4687|0.9357|0.1670
71904472|NCT04047121|143330592|SUPERIORITY||Hazard Ratio (HR)|0.7228||||0.1087|TWO_SIDED|95.0|0.4861|1.0747|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.0747|0.4861|0.1087
71904473|NCT04047121|143330592|SUPERIORITY||Hazard Ratio (HR)|0.8402||||0.3212|TWO_SIDED|95.0|0.5957|1.1852|||Regression, Cox|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.1852|0.5957|0.3212
71904474|NCT04047121|143330593|SUPERIORITY|||||||0.9361|||||||Chi-squared|||||||0.9361
71904475|NCT04047121|143330593|SUPERIORITY|||||||0.3851|||||||Chi-squared|||||||0.3851
71904476|NCT04047121|143330593|SUPERIORITY|||||||0.599|||||||Chi-squared|||||||0.5990
71904477|NCT04047121|143330593|SUPERIORITY||Odds Ratio (OR)|0.9954||||0.986|TWO_SIDED|95.0|0.5962|1.662|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||1.6620|0.5962|0.9860
71904478|NCT04047121|143330593|SUPERIORITY||Odds Ratio (OR)|1.2959||||0.5813|TWO_SIDED|95.0|0.5158|3.2558|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement.) on the outcome measure, multivariable analysis was performed.||3.2558|0.5158|0.5813
71904479|NCT04047121|143330593|SUPERIORITY||Odds Ratio (OR)|1.8182||||0.1789|TWO_SIDED|95.0|0.7604|4.3473|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.3473|0.7604|0.1789
71904480|NCT04047121|143330594|SUPERIORITY|||||||0.4009|||||||Chi-squared|||||||0.4009
71904481|NCT04047121|143330594|SUPERIORITY|||||||0.9765|||||||Chi-squared|||||||0.9765
71904482|NCT04047121|143330594|SUPERIORITY|||||||0.2849|||||||Chi-squared|||||||0.2849
71904483|NCT04047121|143330594|SUPERIORITY||Odds Ratio (OR)|0.8252||||0.5289|TWO_SIDED|95.0|0.4538|1.5007|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5007|0.4538|0.5289
71904484|NCT04047121|143330594|SUPERIORITY||Odds Ratio (OR)|0.9408||||0.927|TWO_SIDED|95.0|0.2553|3.4678|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4678|0.2553|0.9270
71904485|NCT04047121|143330594|SUPERIORITY||Odds Ratio (OR)|0.3968||||0.0707|TWO_SIDED|95.0|0.1456|1.0812|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0812|0.1456|0.0707
71904486|NCT04047121|143330595|SUPERIORITY|||||||0.2061|||||||Chi-squared|||||||0.2061
71904487|NCT04047121|143330595|SUPERIORITY|||||||0.1908|||||||Chi-squared|||||||0.1908
71904488|NCT04047121|143330596|SUPERIORITY|||||||0.8033|||||||Chi-squared|||||||0.8033
71904489|NCT04047121|143330596|SUPERIORITY|||||||0.6669|||||||Chi-squared|||||||0.6669
71904490|NCT04047121|143330596|SUPERIORITY|||||||0.6477|||||||Chi-squared|||||||0.6477
71904491|NCT04047121|143330596|SUPERIORITY||Odds Ratio (OR)|0.7948||||0.5509|TWO_SIDED|95.0|0.3736|1.6907|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6907|0.3736|0.5509
71904492|NCT04047121|143330596|SUPERIORITY||Odds Ratio (OR)|0.6814||||0.6216|TWO_SIDED|95.0|0.1486|3.125|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1250|0.1486|0.6216
71904493|NCT04047121|143330596|SUPERIORITY||Odds Ratio (OR)|0.6974||||0.5506|TWO_SIDED|95.0|0.2135|2.2781|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2781|0.2135|0.5506
71904494|NCT04047121|143330597|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.1030
71904495|NCT04047121|143330597|SUPERIORITY|||||||0.9317|||||||Chi-squared|||||||0.9317
71904496|NCT04047121|143330597|SUPERIORITY|||||||0.242|||||||Chi-squared|||||||0.2420
71904497|NCT04047121|143330597|SUPERIORITY||Odds Ratio (OR)|1.7474||||0.0869|TWO_SIDED|95.0|0.9222|3.3107|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.3107|0.9222|0.0869
71904498|NCT04047121|143330597|SUPERIORITY||Odds Ratio (OR)|1.1346||||0.8228|TWO_SIDED|95.0|0.3757|3.4266|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.4266|0.3757|0.8228
71904499|NCT04047121|143330597|SUPERIORITY||Odds Ratio (OR)|1.565||||0.4855|TWO_SIDED|95.0|0.4446|5.5086|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.5086|0.4446|0.4855
71904500|NCT04047121|143330599|SUPERIORITY|||||||0.5092|||||||Chi-squared|||||||0.5092
71904501|NCT04047121|143330599|SUPERIORITY|||||||0.0201|||||||Chi-squared|||||||0.0201
71904502|NCT04047121|143330599|SUPERIORITY|||||||0.2799|||||||Chi-squared|||||||0.2799
71904503|NCT04047121|143330599|SUPERIORITY||Odds Ratio (OR)|0.9021||||0.5772|TWO_SIDED|95.0|0.6281|1.2958|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2958|0.6281|0.5772
71904504|NCT04047121|143330599|SUPERIORITY||Odds Ratio (OR)|1.3953||||0.3272|TWO_SIDED|95.0|0.7166|2.7169|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7169|0.7166|0.3272
71904505|NCT04047121|143330599|SUPERIORITY||Odds Ratio (OR)|1.3527||||0.3011|TWO_SIDED|95.0|0.763|2.3983|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3983|0.7630|0.3011
71904506|NCT04047121|143330600|SUPERIORITY|||||||0.2931|||||||Chi-squared|||||||0.2931
71904507|NCT04047121|143330600|SUPERIORITY|||||||0.3135|||||||Chi-squared|||||||0.3135
71904508|NCT04047121|143330600|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71904509|NCT04047121|143330600|SUPERIORITY||Odds Ratio (OR)|0.8369||||0.6772|TWO_SIDED|95.0|0.3618|1.9356|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.9356|0.3618|0.6772
71904510|NCT04047121|143330600|SUPERIORITY||Odds Ratio (OR)|5.253||||0.0013|TWO_SIDED|95.0|1.9061|14.477|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||14.4770|1.9061|0.0013
71904511|NCT04047121|143330601|SUPERIORITY|||||||0.5217|||||||Chi-squared|||||||0.5217
71904512|NCT04047121|143330601|SUPERIORITY|||||||0.0432|||||||Chi-squared|||||||0.0432
71904513|NCT04047121|143330601|SUPERIORITY|||||||0.2573|||||||Chi-squared|||||||0.2573
71904514|NCT04047121|143330601|SUPERIORITY||Odds Ratio (OR)|0.8593||||0.5368|TWO_SIDED|95.0|0.5311|1.3902|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3902|0.5311|0.5368
71904515|NCT04047121|143330601|SUPERIORITY||Odds Ratio (OR)|1.2892||||0.4685|TWO_SIDED|95.0|0.6488|2.5616|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.5616|0.6488|0.4685
71904516|NCT04047121|143330601|SUPERIORITY||Odds Ratio (OR)|1.3598||||0.3112|TWO_SIDED|95.0|0.7502|2.4648|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4648|0.7502|0.3112
71904517|NCT04047121|143330602|SUPERIORITY|||||||0.409|||||||Chi-squared|||||||0.4090
71904518|NCT04047121|143330602|SUPERIORITY|||||||0.0249|||||||Chi-squared|||||||0.0249
71904519|NCT04047121|143330602|SUPERIORITY|||||||0.0103|||||||Chi-squared|||||||0.0103
71904520|NCT04047121|143330602|SUPERIORITY||Odds Ratio (OR)|1.1302||||0.5415|TWO_SIDED|95.0|0.763|1.6741|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6741|0.7630|0.5415
71904521|NCT04047121|143330602|SUPERIORITY||Odds Ratio (OR)|2.0118||||0.0596|TWO_SIDED|95.0|0.9722|4.1632|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.1632|0.9722|0.0596
71904522|NCT04047121|143330602|SUPERIORITY||Odds Ratio (OR)|3.4823||||0.0002|TWO_SIDED|95.0|1.793|6.7633|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.7633|1.7930|0.0002
71904523|NCT04047121|143330603|SUPERIORITY|||||||0.2361|||||||Chi-squared|||||||0.2361
71853836|NCT04748445|143221952|OTHER||Slope|-1.519|STANDARD_ERROR_OF_MEAN|2.769|<|0.0001|TWO_SIDED|90.0|-1.978|-1.06|||Mixed Models Analysis|||AHH\_Max Phonation Time (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.060|-1.978|<.0001
71853837|NCT04748445|143221952|OTHER||Slope|6.899|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||EE\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-8).||||<.0001
71853838|NCT04748445|143221952|OTHER||Slope|-1.743|STANDARD_ERROR_OF_MEAN|0.0|<|0.0001|TWO_SIDED|90.0|||||Mixed Models Analysis|||MM\_Jitter Local Absolute (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-7).||||<.0001
71853839|NCT04748445|143221953|OTHER||Slope|-1.326|STANDARD_ERROR_OF_MEAN|1.174||0.9103|TWO_SIDED|90.0|-2.079|1.814|||Mixed Models Analysis|||EE\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||1.814|-2.079|0.9103
71853840|NCT04748445|143221953|OTHER||Slope|0.007667|STANDARD_ERROR_OF_MEAN|1.741||0.6605|TWO_SIDED|90.0|-0.02119|0.03653|||Mixed Models Analysis|||EE\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03653|-0.02119|0.6605
71853841|NCT04748445|143221953|OTHER||Slope|1.268|STANDARD_ERROR_OF_MEAN|2.82|<|0.0001|TWO_SIDED|90.0|0.8012|1.736|||Mixed Models Analysis|||EE\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.736|0.8012|<.0001
71853842|NCT04748445|143221953|OTHER||Slope|-1.752|STANDARD_ERROR_OF_MEAN|2.127||0.4117|TWO_SIDED|90.0|-5.276|1.773|||Mixed Models Analysis|||EE\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-1).||1.773|-5.276|0.4117
71853843|NCT04748445|143221953|OTHER||Slope|1.39|STANDARD_ERROR_OF_MEAN|1.262||0.2728|TWO_SIDED|90.0|-7.012|3.482|||Mixed Models Analysis|||EE\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.482|-7.012|0.2728
71853844|NCT04748445|143221953|OTHER||Slope|-1.407|STANDARD_ERROR_OF_MEAN|1.194||0.2411|TWO_SIDED|90.0|-3.385|5.724|||Mixed Models Analysis|||EE\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||5.724|-3.385|0.2411
71853845|NCT04748445|143221953|OTHER||Slope|-0.004466|STANDARD_ERROR_OF_MEAN|8.869||0.9599|TWO_SIDED|90.0|-0.1514|0.1425|||Mixed Models Analysis|||EE\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1425|-0.1514|0.9599
71853846|NCT04748445|143221953|OTHER||Slope|-0.1572|STANDARD_ERROR_OF_MEAN|9.127||0.0875|TWO_SIDED|90.0|-0.3084|-0.005942|||Mixed Models Analysis|||EE\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.005942|-0.3084|0.0875
71853847|NCT04748445|143221953|OTHER||Slope|1.248|STANDARD_ERROR_OF_MEAN|7.598||0.1029|TWO_SIDED|90.0|-1.072|2.507|||Mixed Models Analysis|||EE\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2 and for lower limit it was 10\^-3).||2.507|-1.072|0.1029
71853848|NCT04748445|143221953|OTHER||Slope|-1.054|STANDARD_ERROR_OF_MEAN|7.218||0.1468|TWO_SIDED|90.0|-2.25|1.423|||Mixed Models Analysis|||EE\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-1. For upper limit and dispersion value it was 10\^-2).||1.423|-2.250|0.1468
71853849|NCT04748445|143221953|OTHER||Slope|0.05944|STANDARD_ERROR_OF_MEAN|6.536||0.3649|TWO_SIDED|90.0|-0.04887|0.1678|||Mixed Models Analysis|||EE\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1678|-0.04887|0.3649
71853850|NCT04748445|143221953|OTHER||Slope|-0.03115|STANDARD_ERROR_OF_MEAN|6.007||0.605|TWO_SIDED|90.0|-0.1307|0.06839|||Mixed Models Analysis|||EE\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06839|-0.1307|0.6050
71853851|NCT04748445|143221953|OTHER||Slope|-0.01908|STANDARD_ERROR_OF_MEAN|5.932||0.7483|TWO_SIDED|90.0|-0.1174|0.07922|||Mixed Models Analysis|||EE\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.07922|-0.1174|0.7483
71853852|NCT04748445|143221953|OTHER||Slope|-6.574|STANDARD_ERROR_OF_MEAN|5.105||0.9897|TWO_SIDED|90.0|-8.526|8.394|||Mixed Models Analysis|||EE\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-4).||8.394|-8.526|0.9897
71853853|NCT04748445|143221953|OTHER||Slope|5.026|STANDARD_ERROR_OF_MEAN|5.176||0.9228|TWO_SIDED|90.0|-8.074|9.08|||Mixed Models Analysis|||EE\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||9.080|-8.074|0.9228
71853854|NCT04748445|143221953|OTHER||Slope|0.08365|STANDARD_ERROR_OF_MEAN|2.873||0.0043|TWO_SIDED|90.0|0.03604|0.1313|||Mixed Models Analysis|||EE\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1313|0.03604|0.0043
71853855|NCT04748445|143221953|OTHER||Slope|0.02906|STANDARD_ERROR_OF_MEAN|1.181||0.0153|TWO_SIDED|90.0|0.009486|0.04863|||Mixed Models Analysis|||EE\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.04863|0.009486|0.0153
71904524|NCT04047121|143330603|SUPERIORITY|||||||0.7474|||||||Chi-squared|||||||0.7474
71904525|NCT04047121|143330603|SUPERIORITY|||||||0.2118|||||||Chi-squared|||||||0.2118
71853856|NCT04748445|143221953|OTHER||Slope|3.96|STANDARD_ERROR_OF_MEAN|1.447||0.0071|TWO_SIDED|90.0|1.563|6.357|||Mixed Models Analysis|||EE\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.357|1.563|0.0071
71853857|NCT04748445|143221953|OTHER||Slope|2.816|STANDARD_ERROR_OF_MEAN|1.026||0.007|TWO_SIDED|90.0|1.115|4.516|||Mixed Models Analysis|||EE\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.516|1.115|0.0070
71853858|NCT04748445|143221953|OTHER||Slope|0.007814|STANDARD_ERROR_OF_MEAN|1.034||0.4513|TWO_SIDED|90.0|-0.009323|0.02495|||Mixed Models Analysis|||EE\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02495|-0.009323|0.4513
71853859|NCT04748445|143221953|OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|8.443||0.1753|TWO_SIDED|90.0|-2.483|2.55|||Mixed Models Analysis|||EE\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.550|-2.483|0.1753
71853860|NCT04748445|143221953|OTHER||Slope|2.528|STANDARD_ERROR_OF_MEAN|8.228||0.0026|TWO_SIDED|90.0|1.164|3.891|||Mixed Models Analysis|||EE\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion it was 10\^-3).||3.891|1.164|0.0026
71853861|NCT04748445|143221953|OTHER||Slope|0.01755|STANDARD_ERROR_OF_MEAN|7.204||0.0162|TWO_SIDED|90.0|0.005616|0.02949|||Mixed Models Analysis|||EE\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02949|0.005616|0.0162
71853862|NCT04748445|143221953|OTHER||Slope|2.673|STANDARD_ERROR_OF_MEAN|5.892|<|0.0001|TWO_SIDED|90.0|1.697|3.65|||Mixed Models Analysis|||EE\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.650|1.697|<.0001
71853863|NCT04748445|143221953|OTHER||Slope|0.01394|STANDARD_ERROR_OF_MEAN|5.642||0.0148|TWO_SIDED|90.0|0.004595|0.02329|||Mixed Models Analysis|||EE\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02329|0.004595|0.0148
71853864|NCT04748445|143221953|OTHER||Slope|0.01547|STANDARD_ERROR_OF_MEAN|6.666||0.0219|TWO_SIDED|90.0|0.004425|0.02652|||Mixed Models Analysis|||EE\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02652|0.004425|0.0219
71853865|NCT04748445|143221953|OTHER||Slope|1.118|STANDARD_ERROR_OF_MEAN|6.122||0.0703|TWO_SIDED|90.0|1.032|2.132|||Mixed Models Analysis|||EE\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-2. For lower limit and dispersion value it was 10\^-3).||2.132|1.032|0.0703
71853866|NCT04748445|143221953|OTHER||Slope|0.0116|STANDARD_ERROR_OF_MEAN|5.226||0.0282|TWO_SIDED|90.0|0.00294|0.02026|||Mixed Models Analysis|||EE\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02026|0.002940|0.0282
71853867|NCT04748445|143221953|OTHER||Slope|0.04771|STANDARD_ERROR_OF_MEAN|3.351||0.157|TWO_SIDED|90.0|-0.007823|0.1032|||Mixed Models Analysis|||EE\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1032|-0.007823|0.1570
71853868|NCT04748445|143221953|OTHER||Slope|0.0008053|STANDARD_ERROR_OF_MEAN|9.807||0.4131|TWO_SIDED|90.0|-0.0008199|0.002431|||Mixed Models Analysis|||EE\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002431|-0.0008199|0.4131
71853869|NCT04748445|143221953|OTHER||Slope|-0.03945|STANDARD_ERROR_OF_MEAN|1.892||0.0391|TWO_SIDED|90.0|-0.0708|-0.008096|||Mixed Models Analysis|||EE\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008096|-0.07080|0.0391
71853870|NCT04748445|143221953|OTHER||Slope|-0.07075|STANDARD_ERROR_OF_MEAN|8.409||0.4018|TWO_SIDED|90.0|-0.2101|0.0686|||Mixed Models Analysis|||EE\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06860|-0.2101|0.4018
71853871|NCT04748445|143221953|OTHER||Slope|1.658|STANDARD_ERROR_OF_MEAN|3.607||0.6466|TWO_SIDED|90.0|-4.319|7.635|||Mixed Models Analysis|||EE\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.635|-4.319|0.6466
71853872|NCT04748445|143221953|OTHER||Slope|1.172|STANDARD_ERROR_OF_MEAN|1.423||0.4118|TWO_SIDED|90.0|-1.186|3.53|||Mixed Models Analysis|||MM\_Cepstral Peak Prominence (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||3.530|-1.186|0.4118
71853873|NCT04748445|143221953|OTHER||Slope|-1.282|STANDARD_ERROR_OF_MEAN|1.965||0.9481|TWO_SIDED|90.0|-3.385|3.129|||Mixed Models Analysis|||MM\_Harmonicity (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||3.129|-3.385|0.9481
71853874|NCT04748445|143221953|OTHER||Slope|0.9159|STANDARD_ERROR_OF_MEAN|2.641||0.0007|TWO_SIDED|90.0|0.4783|1.354|||Mixed Models Analysis|||MM\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.354|0.4783|0.0007
71853875|NCT04748445|143221953|OTHER||Slope|-2.18|STANDARD_ERROR_OF_MEAN|1.894||0.2519|TWO_SIDED|90.0|-5.319|9.585|||Mixed Models Analysis|||MM\_MFCC mean 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-1. For upper limit it was 10\^-2).||9.585|-5.319|0.2519
71853876|NCT04748445|143221953|OTHER||Slope|1.821|STANDARD_ERROR_OF_MEAN|1.028||0.0791|TWO_SIDED|90.0|1.166|3.524|||Mixed Models Analysis|||MM\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-1. For lower limit it was 10\^-2).||3.524|1.166|0.0791
71680657|NCT04281784|142879463|SUPERIORITY||Risk Difference (RD)|-0.009||||0.61|TWO_SIDED|95.0|-0.043|0.025||two-sided test, no adjustment for multiple comparisons|Regression, Linear|ICU care (0,1) regressed on randomization condition (0=usual care, 1=intervention), adjusted for ADRD status, and hospital site.|Robust standard error|Usual care = reference group; intervention arm = comparison group||0.025|-0.043|0.610
71680658|NCT04281784|142879464|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|0.022|STANDARD_ERROR_OF_MEAN|0.058||0.71|TWO_SIDED|95.0|-0.092|0.135|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.135|-0.092|0.710
71680659|NCT04281784|142879465|SUPERIORITY||Risk Difference (RD)|0.487|STANDARD_ERROR_OF_MEAN|0.899||0.588|TWO_SIDED|95.0|-1.275|2.249||two-sided test, no adjustment for multiple comparisons|Regression, Linear|Died within 30 days after randomization regressed on randomization condition (0=usual care, 1=intervention) adjusted for hospital and ADRD status|Robust standard error|Usual care=reference group; intervention arm = comparison group||2.249|-1.275|0.588
71680660|NCT04281784|142879466|SUPERIORITY|Higher cost indicates worse outcome. Missing if cost data unavailable from Finance Office.|Slope|-0.028|STANDARD_ERROR_OF_MEAN|0.069||0.685|TWO_SIDED|95.0|-0.162|0.107|||other type of regression|Generalized linear model (gamma family, log link); Outcome on study arm (0=control, 1=intervention) adjusted for hospital and ADRD status, robust SEs.|Robust standard error|Superior outcome for Group 2||0.107|-0.162|0.685
71680661|NCT04322539|142879467|SUPERIORITY||Stratified Hazard Ratio|0.662|||<|0.001|TWO_SIDED|95.0|0.549|0.8||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between 2 treatment groups (fruquintinib vs placebo), together with its 95 percent (%) confidence interval (CI), was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.800|0.549|< .001
71680662|NCT04322539|142879468|SUPERIORITY||Hazard Ratio (HR)|0.321|||<|0.001|TWO_SIDED|95.0|0.267|0.386||Raw unadjusted p-value was obtained by using a stratified log-rank test accounting for the randomization schedule stratification factors.|stratified log-rank test||The HR between the 2 treatment groups (fruquintinib vs placebo), together with its 95% CI, was calculated from a stratified Cox proportional hazards model accounting for the randomization schedule stratification factors.|||0.386|0.267|< .001
71853877|NCT04748445|143221953|OTHER||Slope|-0.2064|STANDARD_ERROR_OF_MEAN|8.474||0.0163|TWO_SIDED|90.0|-0.3468|-0.06599|||Mixed Models Analysis|||MM\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.06599|-0.3468|0.0163
71853878|NCT04748445|143221953|OTHER||Slope|-1.265|STANDARD_ERROR_OF_MEAN|9.67||0.1932|TWO_SIDED|90.0|-2.867|3.375|||Mixed Models Analysis|||MM\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and dispersion value it was 10\^-2. For lower limit and estimated value it was 10\^-1).||3.375|-2.867|0.1932
71853879|NCT04748445|143221953|OTHER||Slope|0.02851|STANDARD_ERROR_OF_MEAN|9.96||0.7752|TWO_SIDED|90.0|-0.1365|0.1936|||Mixed Models Analysis|||MM\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1936|-0.1365|0.7752
71853880|NCT04748445|143221953|OTHER||Slope|1.209|STANDARD_ERROR_OF_MEAN|7.569||0.1126|TWO_SIDED|90.0|-4.48|2.464|||Mixed Models Analysis|||MM\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-1. For lower limit it was 10\^-3. For dispersion value it was 10\^-2).||2.464|-4.480|0.1126
71853881|NCT04748445|143221953|OTHER||Slope|-0.2215|STANDARD_ERROR_OF_MEAN|8.498||0.0102|TWO_SIDED|90.0|-0.3624|-0.08072|||Mixed Models Analysis|||MM\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.08072|-0.3624|0.0102
71853882|NCT04748445|143221953|OTHER||Slope|0.0556|STANDARD_ERROR_OF_MEAN|7.072||0.4332|TWO_SIDED|90.0|-0.06159|0.1728|||Mixed Models Analysis|||MM\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1728|-0.06159|0.4332
71853883|NCT04748445|143221953|OTHER||Slope|0.01214|STANDARD_ERROR_OF_MEAN|6.19||0.8448|TWO_SIDED|90.0|-0.09044|0.1147|||Mixed Models Analysis|||MM\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1147|-0.09044|0.8448
71853884|NCT04748445|143221953|OTHER||Slope|-0.1106|STANDARD_ERROR_OF_MEAN|4.852||0.0244|TWO_SIDED|90.0|-0.191|-0.03016|||Mixed Models Analysis|||MM\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03016|-0.1910|0.0244
71680663|NCT04322539|142879469|SUPERIORITY||Adjusted difference|1.5||||0.059|TWO_SIDED|95.0|0.4|2.7||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||2.7|0.4|.059
71680664|NCT04322539|142879470|SUPERIORITY||Adjusted difference|39.4|||<|0.001|TWO_SIDED|95.0|32.8|46.0||p-value was calculated from a stratified Cochran-Mantel Haenszel test accounting for the randomization schedule stratification factors.|Cochran-Mantel-Haenszel||The adjusted difference and its 95% CI were calculated using the Wald method from Cochran-Mantel Haenszel test to account for the randomization schedule stratification factors.|||46.0|32.8|<.001
71853885|NCT04748445|143221953|OTHER||Slope|-0.04884|STANDARD_ERROR_OF_MEAN|4.827||0.3136|TWO_SIDED|90.0|-0.1288|0.03115|||Mixed Models Analysis|||MM\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03115|-0.1288|0.3136
71904526|NCT04047121|143330603|SUPERIORITY||Odds Ratio (OR)|1.3811||||0.1978|TWO_SIDED|95.0|0.8449|2.2576|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2576|0.8449|0.1978
71904527|NCT04047121|143330603|SUPERIORITY||Odds Ratio (OR)|1.0614||||0.8893|TWO_SIDED|95.0|0.4587|2.4559|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.4559|0.4587|0.8893
71904528|NCT04047121|143330603|SUPERIORITY||Odds Ratio (OR)|0.5811||||0.1553|TWO_SIDED|95.0|0.2748|1.2286|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2286|0.2748|0.1553
71904529|NCT04047121|143330604|SUPERIORITY|||||||0.6767|||||||Chi-squared|||||||0.6767
71853886|NCT04748445|143221953|OTHER||Slope|0.036|STANDARD_ERROR_OF_MEAN|5.634||0.524|TWO_SIDED|90.0|-0.05736|0.1294|||Mixed Models Analysis|||MM\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1294|-0.05736|0.5240
71853887|NCT04748445|143221953|OTHER||Slope|2.909|STANDARD_ERROR_OF_MEAN|3.096||0.3493|TWO_SIDED|90.0|-2.222|8.039|||Mixed Models Analysis|||MM\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||8.039|-2.222|0.3493
71853888|NCT04748445|143221953|OTHER||Slope|1.72|STANDARD_ERROR_OF_MEAN|2.595||0.5087|TWO_SIDED|90.0|-2.58|6.019|||Mixed Models Analysis|||MM\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||6.019|-2.580|0.5087
71853889|NCT04748445|143221953|OTHER||Slope|0.004403|STANDARD_ERROR_OF_MEAN|1.503||0.7701|TWO_SIDED|90.0|-0.02051|0.02931|||Mixed Models Analysis|||MM\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02931|-0.02051|0.7701
71680665|NCT04322539|142879476|OTHER|||||||0.06|||||||Wald test|||CminSS Based on the Starting Dose for OS Exposure-Response Analyses||||0.0600
71853890|NCT04748445|143221953|OTHER||Slope|0.007542|STANDARD_ERROR_OF_MEAN|1.639||0.6461|TWO_SIDED|90.0|-0.01961|0.0347|||Mixed Models Analysis|||MM\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.03470|-0.01961|0.6461
71853891|NCT04748445|143221953|OTHER||Slope|2.386|STANDARD_ERROR_OF_MEAN|8.233||0.0044|TWO_SIDED|90.0|1.022|3.75|||Mixed Models Analysis|||MM\_MFCC std 05 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||3.750|1.022|0.0044
71904530|NCT04047121|143330604|SUPERIORITY|||||||0.1141|||||||Chi-squared|||||||0.1141
71904531|NCT04047121|143330604|SUPERIORITY|||||||0.1497|||||||Chi-squared|||||||0.1497
71904532|NCT04047121|143330604|SUPERIORITY||Odds Ratio (OR)|0.8556||||0.5228|TWO_SIDED|95.0|0.5303|1.3804|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.3804|0.5303|0.5228
71904533|NCT04047121|143330604|SUPERIORITY||Odds Ratio (OR)|2.5125||||0.0277|TWO_SIDED|95.0|1.1062|5.7063|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.7063|1.1062|0.0277
71904534|NCT04047121|143330604|SUPERIORITY||Odds Ratio (OR)|0.6993||||0.324|TWO_SIDED|95.0|0.3435|1.4236|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4236|0.3435|0.3240
71904535|NCT04047121|143330605|SUPERIORITY|||||||0.6318|||||||t-test, 2 sided|||||||0.6318
71904536|NCT04047121|143330605|SUPERIORITY|||||||0.3802|||||||t-test, 2 sided|||||||0.3802
71904537|NCT04047121|143330605|SUPERIORITY|||||||0.2424|||||||t-test, 2 sided|||||||0.2424
71904538|NCT04047121|143330605|SUPERIORITY||Odds Ratio (OR)|0.0347||||0.1753|TWO_SIDED|95.0|-0.0155|0.0848|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0848|-0.0155|0.1753
71904539|NCT04047121|143330605|SUPERIORITY||Odds Ratio (OR)|0.0194||||0.6114|TWO_SIDED|95.0|-0.0553|0.0941|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0941|-0.0553|0.6114
71853892|NCT04748445|143221953|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.243||0.2022|TWO_SIDED|90.0|-4.663|3.652|||Mixed Models Analysis|||MM\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.652|-4.663|0.2022
71853893|NCT04748445|143221953|OTHER||Slope|0.002902|STANDARD_ERROR_OF_MEAN|1.082||0.789|TWO_SIDED|90.0|-0.01503|0.02084|||Mixed Models Analysis|||MM\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02084|-0.01503|0.7890
71853894|NCT04748445|143221953|OTHER||Slope|1.615|STANDARD_ERROR_OF_MEAN|1.118||0.151|TWO_SIDED|90.0|-2.371|3.467|||Mixed Models Analysis|||MM\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.467|-2.371|0.1510
71853895|NCT04748445|143221953|OTHER||Slope|1.116|STANDARD_ERROR_OF_MEAN|1.104||0.3138|TWO_SIDED|90.0|-7.126|2.945|||Mixed Models Analysis|||MM\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||2.945|-7.126|0.3138
71904540|NCT04047121|143330605|SUPERIORITY||Odds Ratio (OR)|0.0345||||0.2977|TWO_SIDED|95.0|-0.0304|0.0993|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0993|-0.0304|0.2977
71853896|NCT04748445|143221953|OTHER||Slope|-0.002168|STANDARD_ERROR_OF_MEAN|9.632||0.8223|TWO_SIDED|90.0|-0.01813|0.01379|||Mixed Models Analysis|||MM\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01379|-0.01813|0.8223
71853897|NCT04748445|143221953|OTHER||Slope|1.394|STANDARD_ERROR_OF_MEAN|1.081||0.1997|TWO_SIDED|90.0|-3.978|3.185|||Mixed Models Analysis|||MM\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-2. For lower limit it was 10\^-3).||3.185|-3.978|0.1997
71853898|NCT04748445|143221953|OTHER||Slope|0.01375|STANDARD_ERROR_OF_MEAN|6.622||0.0398|TWO_SIDED|90.0|0.00278|0.02473|||Mixed Models Analysis|||MM\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.02473|0.002780|0.0398
71853899|NCT04748445|143221953|OTHER||Slope|-0.002892|STANDARD_ERROR_OF_MEAN|1.205||0.8107|TWO_SIDED|90.0|-0.02286|0.01707|||Mixed Models Analysis|||MM\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01707|-0.02286|0.8107
71853900|NCT04748445|143221953|OTHER||Slope|-3.105|STANDARD_ERROR_OF_MEAN|3.256||0.9242|TWO_SIDED|90.0|-5.706|5.085|||Mixed Models Analysis|||MM\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.085|-5.706|0.9242
71853901|NCT04748445|143221953|OTHER||Slope|0.0006145|STANDARD_ERROR_OF_MEAN|9.704||0.5277|TWO_SIDED|90.0|-0.0009936|0.002223|||Mixed Models Analysis|||MM\_Shimmer Local dB (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002223|-0.0009936|0.5277
71853902|NCT04748445|143221953|OTHER||Slope|-2.911|STANDARD_ERROR_OF_MEAN|1.969||0.1418|TWO_SIDED|90.0|-6.174|3.522|||Mixed Models Analysis|||MM\_Spectral Flatness (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||3.522|-6.174|0.1418
71853903|NCT04748445|143221953|OTHER||Slope|-0.1487|STANDARD_ERROR_OF_MEAN|8.77||0.0924|TWO_SIDED|90.0|-0.294|-0.003375|||Mixed Models Analysis|||MM\_Third Octave Band (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.003375|-0.2940|0.0924
71853904|NCT04748445|143221953|OTHER||Slope|3.089|STANDARD_ERROR_OF_MEAN|3.396||0.9277|TWO_SIDED|90.0|-5.318|5.936|||Mixed Models Analysis|||MM\_VLHR (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-2. For estimated value it was 10\^-3).||5.936|-5.318|0.9277
71853905|NCT04748445|143221953|OTHER||Slope|0.8362|STANDARD_ERROR_OF_MEAN|2.077|<|0.0001|TWO_SIDED|90.0|0.492|1.18|||Mixed Models Analysis|||READ\_MFCC mean 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||1.180|0.4920|<.0001
71853906|NCT04748445|143221953|OTHER||Slope|0.03559|STANDARD_ERROR_OF_MEAN|1.147||0.7568|TWO_SIDED|90.0|-0.1545|0.2256|||Mixed Models Analysis|||READ\_MFCC mean 02 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.2256|-0.1545|0.7568
71853907|NCT04748445|143221953|OTHER||Slope|0.2043|STANDARD_ERROR_OF_MEAN|7.752||0.0095|TWO_SIDED|90.0|0.07585|0.3328|||Mixed Models Analysis|||READ\_MFCC mean 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.3328|0.07585|0.0095
71853908|NCT04748445|143221953|OTHER||Slope|-0.0828|STANDARD_ERROR_OF_MEAN|6.413||0.1991|TWO_SIDED|90.0|-0.1891|0.02348|||Mixed Models Analysis|||READ\_MFCC mean 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02348|-0.1891|0.1991
71853909|NCT04748445|143221953|OTHER||Slope|-0.02415|STANDARD_ERROR_OF_MEAN|5.26||0.6469|TWO_SIDED|90.0|-0.1113|0.06301|||Mixed Models Analysis|||READ\_MFCC mean 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06301|-0.1113|0.6469
71904541|NCT04047121|143330606|SUPERIORITY|||||||0.1473|||||||t-test, 2 sided|||||||0.1473
71904542|NCT04047121|143330606|SUPERIORITY|||||||0.8747|||||||t-test, 2 sided|||||||0.8747
71904543|NCT04047121|143330606|SUPERIORITY|||||||0.5265|||||||t-test, 2 sided|||||||0.5265
71822041|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|18.3|||<|0.001|TWO_SIDED|95.0|11.4|25.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36||25.1|11.4|<0.001
71853910|NCT04748445|143221953|OTHER||Slope|-0.1209|STANDARD_ERROR_OF_MEAN|4.904||0.015|TWO_SIDED|90.0|-0.2022|-0.03967|||Mixed Models Analysis|||READ\_MFCC mean 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.03967|-0.2022|0.0150
71853911|NCT04748445|143221953|OTHER||Slope|0.02617|STANDARD_ERROR_OF_MEAN|4.639||0.5736|TWO_SIDED|90.0|-0.0507|0.103|||Mixed Models Analysis|||READ\_MFCC mean 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.1030|-0.05070|0.5736
71904544|NCT04047121|143330606|SUPERIORITY||Odds Ratio (OR)|-0.0457||||0.2522|TWO_SIDED|95.0|-0.1239|0.0325|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0325|-0.1239|0.2522
71904545|NCT04047121|143330606|SUPERIORITY||Odds Ratio (OR)|0.0278||||0.6701|TWO_SIDED|95.0|-0.1003|0.1559|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1559|-0.1003|0.6701
71904546|NCT04047121|143330606|SUPERIORITY||Odds Ratio (OR)|0.1693||||0.1017|TWO_SIDED|95.0|-0.0334|0.372|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3720|-0.0334|0.1017
71822042|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|7.7||||0.056|TWO_SIDED|95.0|-0.8|16.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36||16.1|-0.8|0.056
71853912|NCT04748445|143221953|OTHER||Slope|-0.07305|STANDARD_ERROR_OF_MEAN|4.267||0.0894|TWO_SIDED|90.0|-0.1438|-0.002335|||Mixed Models Analysis|||READ\_MFCC mean 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002335|-0.1438|0.0894
71853913|NCT04748445|143221953|OTHER||Slope|-2.369|STANDARD_ERROR_OF_MEAN|4.428||0.5936|TWO_SIDED|90.0|-9.706|4.968|||Mixed Models Analysis|||READ\_MFCC mean 09 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||4.968|-9.706|0.5936
71904547|NCT04047121|143330607|SUPERIORITY|||||||0.2246|||||||t-test, 2 sided|||||||0.2246
71904548|NCT04047121|143330607|SUPERIORITY|||||||0.2101|||||||t-test, 2 sided|||||||0.2101
71904549|NCT04047121|143330607|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.0030
71904550|NCT04047121|143330607|SUPERIORITY||Odds Ratio (OR)|0.414||||0.3324|TWO_SIDED|95.0|-0.4231|1.2511|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.2511|-0.4231|0.3324
71904551|NCT04047121|143330607|SUPERIORITY||Odds Ratio (OR)|1.1712||||0.1367|TWO_SIDED|95.0|-0.3713|2.7138|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.7138|-0.3713|0.1367
71904552|NCT04047121|143330607|SUPERIORITY||Odds Ratio (OR)|1.8099||||0.0028|TWO_SIDED|95.0|0.6219|2.9978|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9978|0.6219|0.0028
71904553|NCT04047121|143330608|SUPERIORITY|||||||0.2667|||||||t-test, 2 sided|||||||0.2667
71904554|NCT04047121|143330608|SUPERIORITY|||||||0.657|||||||t-test, 2 sided|||||||0.6570
71904555|NCT04047121|143330608|SUPERIORITY|||||||0.5403|||||||t-test, 2 sided|||||||0.5403
71904556|NCT04047121|143330608|SUPERIORITY||Odds Ratio (OR)|0.9159||||0.1167|TWO_SIDED|95.0|-0.2283|2.06|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.0600|-0.2283|0.1167
71904557|NCT04047121|143330608|SUPERIORITY||Odds Ratio (OR)|-0.0336||||0.9722|TWO_SIDED|95.0|-1.9238|1.8567|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.8567|-1.9238|0.9722
71904558|NCT04047121|143330608|SUPERIORITY||Odds Ratio (OR)|0.2064||||0.8455|TWO_SIDED|95.0|-1.8689|2.2817|||Regression, Logistic|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.2817|-1.8689|0.8455
71680666|NCT04322539|142879476|OTHER|||||||0.8065|||||||Wald test|||CminSS Based on the Adjusted RDI for OS Exposure-Response Analyses||||0.8065
71904559|NCT04047121|143330609|SUPERIORITY|||||||0.3142|||||||t-test, 2 sided|||||||0.3142
71904560|NCT04047121|143330609|SUPERIORITY|||||||0.2465|||||||t-test, 2 sided|||||||0.2465
71904561|NCT04047121|143330609|SUPERIORITY|||||||0.5933|||||||t-test, 2 sided|||||||0.5933
71904562|NCT04047121|143330609|SUPERIORITY||Odds Ratio (OR)|-0.0089||||0.7815|TWO_SIDED|95.0|-0.0716|0.0538|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0538|-0.0716|0.7815
71904563|NCT04047121|143330609|SUPERIORITY||Odds Ratio (OR)|0.0337||||0.4446|TWO_SIDED|95.0|-0.0528|0.1202|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1202|-0.0528|0.4446
71904564|NCT04047121|143330609|SUPERIORITY||Odds Ratio (OR)|-0.0333||||0.4733|TWO_SIDED|95.0|-0.1243|0.0577|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0577|-0.1243|0.4733
71904565|NCT04047121|143330610|SUPERIORITY|||||||0.0658|||||||t-test, 2 sided|||||||0.0658
71904566|NCT04047121|143330610|SUPERIORITY|||||||0.3785|||||||t-test, 2 sided|||||||0.3785
71904567|NCT04047121|143330610|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
71904568|NCT04047121|143330610|SUPERIORITY||Odds Ratio (OR)|-0.0425||||0.2523|TWO_SIDED|95.0|-0.1154|0.0303|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0303|-0.1154|0.2523
71904569|NCT04047121|143330610|SUPERIORITY||Odds Ratio (OR)|-0.0388||||0.4068|TWO_SIDED|95.0|-0.1305|0.0529|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0529|-0.1305|0.4068
71904570|NCT04047121|143330610|SUPERIORITY||Odds Ratio (OR)|0.0706||||0.5858|TWO_SIDED|95.0|-0.1833|0.3244|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3244|-0.1833|0.5858
71904571|NCT04047121|143330611|SUPERIORITY|||||||0.3832|||||||t-test, 2 sided|||||||0.3832
71904572|NCT04047121|143330611|SUPERIORITY|||||||0.4631|||||||t-test, 2 sided|||||||0.4631
71904573|NCT04047121|143330611|SUPERIORITY|||||||0.6202|||||||t-test, 2 sided|||||||0.6202
71680667|NCT04322539|142879477|OTHER|||||||0.265|||||||Wald test|||CmaxSS for Gr Dermatological toxicity for Exposure-Response Analyses.||||0.265
71680668|NCT04322539|142879477|OTHER|||||||0.0159|||||||Wald test|||CmaxSS for Gr3+ Dermatological Toxicity for Exposure-Response Analyses.||||0.0159
71680669|NCT04322539|142879477|OTHER|||||||0.484|||||||Wald test|||CmaxSS for Gr Proteinuria for Exposure-Response Analyses.||||0.484
71822043|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|9.0||||0.023|TWO_SIDED|95.0|0.5|17.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36||17.4|0.5|0.023
71853914|NCT04748445|143221953|OTHER||Slope|-0.07377|STANDARD_ERROR_OF_MEAN|3.339||0.029|TWO_SIDED|90.0|-0.1291|-0.01844|||Mixed Models Analysis|||READ\_MFCC mean 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01844|-0.1291|0.0290
71853915|NCT04748445|143221953|OTHER||Slope|0.008703|STANDARD_ERROR_OF_MEAN|3.665||0.8127|TWO_SIDED|90.0|-0.05203|0.06944|||Mixed Models Analysis|||READ\_MFCC mean 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.06944|-0.05203|0.8127
71853916|NCT04748445|143221953|OTHER||Slope|-0.07414|STANDARD_ERROR_OF_MEAN|3.294||0.0262|TWO_SIDED|90.0|-0.1287|-0.01955|||Mixed Models Analysis|||READ\_MFCC mean 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.01955|-0.1287|0.0262
71853917|NCT04748445|143221953|OTHER||Slope|2.929|STANDARD_ERROR_OF_MEAN|2.705||0.2809|TWO_SIDED|90.0|-1.553|7.412|||Mixed Models Analysis|||READ\_MFCC mean 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||7.412|-1.553|0.2809
71822044|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|21.9|||<|0.001|TWO_SIDED|95.0|15.1|28.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52||28.7|15.1|<0.001
71822045|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|11.5||||0.004|TWO_SIDED|95.0|3.1|20.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52||20.0|3.1|0.004
71853918|NCT04748445|143221953|OTHER||Slope|-2.717|STANDARD_ERROR_OF_MEAN|6.612|<|0.0001|TWO_SIDED|90.0|-3.812|-1.621|||Mixed Models Analysis|||READ\_MFCC std 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-1. For dispersion value it was 10\^-2).||-1.621|-3.812|<.0001
71853919|NCT04748445|143221953|OTHER||Slope|-0.05798|STANDARD_ERROR_OF_MEAN|2.961||0.0524|TWO_SIDED|90.0|-0.107|-0.008915|||Mixed Models Analysis|||READ\_MFCC std 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.008915|-0.1070|0.0524
71853920|NCT04748445|143221953|OTHER||Slope|-1.008|STANDARD_ERROR_OF_MEAN|1.778||0.5716|TWO_SIDED|90.0|-3.955|1.938|||Mixed Models Analysis|||READ\_MFCC std 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-2).||1.938|-3.955|0.5716
71853921|NCT04748445|143221953|OTHER||Slope|-0.0223|STANDARD_ERROR_OF_MEAN|1.193||0.064|TWO_SIDED|90.0|-0.04208|-0.002526|||Mixed Models Analysis|||READ\_MFCC std 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||-0.002526|-0.04208|0.0640
71853922|NCT04748445|143221953|OTHER||Slope|-1.336|STANDARD_ERROR_OF_MEAN|1.176||0.2584|TWO_SIDED|90.0|-3.285|6.138|||Mixed Models Analysis|||READ\_MFCC std 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-2. For upper limit it was 10\^-3).||6.138|-3.285|0.2584
71853923|NCT04748445|143221953|OTHER||Slope|-0.006497|STANDARD_ERROR_OF_MEAN|1.413||0.6465|TWO_SIDED|90.0|-0.02992|0.01692|||Mixed Models Analysis|||READ\_MFCC std 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.01692|-0.02992|0.6465
71680670|NCT04322539|142879477|OTHER|||||||0.642|||||||Wald test|||CmaxSS for Gr3+ Proteinuria for Exposure-Response Analyses.||||0.642
71680671|NCT04322539|142879477|OTHER|||||||0.166|||||||Wald test|||CmaxSS for Gr Hemorrhage for Exposure-Response Analyses.||||0.166
71680672|NCT01702532|142879483|SUPERIORITY_OR_OTHER||LS Means Difference|-4.9||||0.0141|TWO_SIDED|95.0|-8.8|-0.99||The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.|ANCOVA|ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed|Comment: The confidence interval is for the difference between treatments groups|Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.||-0.99|-8.80|0.0141
71680673|NCT01846221|142879490|OTHER|||||||0.38|||||||ANOVA|||||||0.38
71822046|NCT02886728|143146000|SUPERIORITY||Difference in Response Rates|14.7|||<|0.001|TWO_SIDED|95.0|6.3|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52||23.1|6.3|<0.001
71822047|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-7.3|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-7.3|<0.001
71680674|NCT01482962|142879501|SUPERIORITY||Odds Ratio (OR)|0.6||||0.038|TWO_SIDED|95.0|0.33|1.08||P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.|Cochran-Mantel-Haenszel|||||1.08|0.33|0.038
71680675|NCT01482962|142879502|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.177|TWO_SIDED|95.0|0.637|1.178|||Stratified Log Rank||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.178|0.637|0.177
71680676|NCT01482962|142879503|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.338|TWO_SIDED|95.0|0.707|1.369|||Stratified Log-rank Test||Hazard ratio (HR) was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.369|0.707|0.338
71680677|NCT01482962|142879508|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.362|TWO_SIDED|95.0|0.679|1.329|||Stratified Log Rank||Hazard ratio was based on a stratified Cox's proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.|||1.329|0.679|0.362
71680678|NCT02052596|142879530|NON_INFERIORITY|Criteria for non-inferiority: At one month after the last vaccine dose (Month 3 or Month 5), the upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies GMC ratio between the Control Group and the GSK1437173A Group had to be below (\<) 1.5,|Adjusted GMC ratio|1.11|||||TWO_SIDED|95.0|1.02|1.21||||Adjustment for baseline concentration and age - pooled variance.||Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.||1.21|1.02|
71680679|NCT02052596|142879531|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PT antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.17|||||TWO_SIDED|95.0|1.0|1.36||||Ancova model: adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.||1.36|1.00|
71680680|NCT02052596|142879531|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-FHA antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.24|||||TWO_SIDED|95.0|1.07|1.44||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.||1.44|1.07|
71680681|NCT02052596|142879531|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PRN antibodies of the Control Group over the GSK1437173A Group had to be \< 1.5.|Adjusted GMC ratio|1.27|||||TWO_SIDED|95.0|1.02|1.58||||Adjustment for baseline concentration - pooled variance.||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.||1.58|1.02|
71680682|NCT02052596|142879532|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-diphtheria (anti-D) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|-0.1|||||TWO_SIDED|95.0|-3.03|2.85||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.||2.85|-3.03|
71680683|NCT02052596|142879532|NON_INFERIORITY|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-tetanus (anti-T) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be \< 10%.|Difference in seropositivity rate|0.01|||||TWO_SIDED|95.0|-1.18|1.27||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.||1.27|-1.18|
71680684|NCT00001656|142879644|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||.04
71853924|NCT04748445|143221953|OTHER||Slope|-1.213|STANDARD_ERROR_OF_MEAN|7.7||0.1177|TWO_SIDED|90.0|-2.489|6.297|||Mixed Models Analysis|||READ\_MFCC std 07 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-2. For dispersion value it was 10\^-3 and for upper limit it was 10\^-4).||6.297|-2.489|0.1177
71853925|NCT04748445|143221953|OTHER||Slope|-0.007959|STANDARD_ERROR_OF_MEAN|9.743||0.4155|TWO_SIDED|90.0|-0.02411|0.008187|||Mixed Models Analysis|||READ\_MFCC std 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.008187|-0.02411|0.4155
71680685|NCT00001656|142879645|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.21
71853926|NCT04748445|143221953|OTHER||Slope|-0.004137|STANDARD_ERROR_OF_MEAN|8.017||0.6067|TWO_SIDED|90.0|-0.01742|0.009148|||Mixed Models Analysis|||READ\_MFCC std 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.009148|-0.01742|0.6067
71680686|NCT00001656|142879646|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.35
71680687|NCT00001656|142879647|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.19
71904574|NCT04047121|143330611|SUPERIORITY||Odds Ratio (OR)|-0.5353||||0.3158|TWO_SIDED|95.0|-1.5812|0.5107|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5107|-1.5812|0.3158
71904575|NCT04047121|143330611|SUPERIORITY||Odds Ratio (OR)|1.3543||||0.1016|TWO_SIDED|95.0|-0.2669|2.9755|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.9755|-0.2669|0.1016
71904576|NCT04047121|143330611|SUPERIORITY||Odds Ratio (OR)|0.8677||||0.2576|TWO_SIDED|95.0|-0.6347|2.37|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3700|-0.6347|0.2576
71904577|NCT04047121|143330612|SUPERIORITY|||||||0.3107|||||||t-test, 2 sided|||||||0.3107
71904578|NCT04047121|143330612|SUPERIORITY|||||||0.3735|||||||t-test, 2 sided|||||||0.3735
71904579|NCT04047121|143330612|SUPERIORITY|||||||0.3863|||||||t-test, 2 sided|||||||0.3863
71904580|NCT04047121|143330612|SUPERIORITY||Odds Ratio (OR)|-1.0337||||0.1918|TWO_SIDED|95.0|-2.5858|0.5184|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.5184|-2.5858|0.1918
71904581|NCT04047121|143330612|SUPERIORITY||Odds Ratio (OR)|-0.9749||||0.4281|TWO_SIDED|95.0|-3.3864|1.4366|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4366|-3.3864|0.4281
71904582|NCT04047121|143330612|SUPERIORITY||Odds Ratio (OR)|-1.8599||||0.1014|TWO_SIDED|95.0|-4.0854|0.3657|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.3657|-4.0854|0.1014
71904583|NCT04047121|143330613|SUPERIORITY|||||||0.4555|||||||t-test, 2 sided|||||||0.4555
71904584|NCT04047121|143330613|SUPERIORITY|||||||0.7164|||||||t-test, 2 sided|||||||0.7164
71904585|NCT04047121|143330613|SUPERIORITY|||||||0.2456|||||||t-test, 2 sided|||||||0.2456
71904586|NCT04047121|143330613|SUPERIORITY||Odds Ratio (OR)|0.0568||||0.0962|TWO_SIDED|95.0|-0.0101|0.1238|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1238|-0.0101|0.0962
71904587|NCT04047121|143330613|SUPERIORITY||Odds Ratio (OR)|-0.0432||||0.3844|TWO_SIDED|95.0|-0.1405|0.0541|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0541|-0.1405|0.3844
71680688|NCT00001656|142879648|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.59
71904588|NCT04047121|143330613|SUPERIORITY||Odds Ratio (OR)|0.0233||||0.5899|TWO_SIDED|95.0|-0.0615|0.1082|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1082|-0.0615|0.5899
71904589|NCT04047121|143330614|SUPERIORITY|||||||0.4133|||||||t-test, 2 sided|||||||0.4133
71904590|NCT04047121|143330614|SUPERIORITY|||||||0.7171|||||||t-test, 2 sided|||||||0.7171
71904591|NCT04047121|143330614|SUPERIORITY|||||||0.8609|||||||t-test, 2 sided|||||||0.8609
71904592|NCT04047121|143330614|SUPERIORITY||Odds Ratio (OR)|-0.0445||||0.6224|TWO_SIDED|95.0|-0.2218|0.1327|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1327|-0.2218|0.6224
71904593|NCT04047121|143330614|SUPERIORITY||Odds Ratio (OR)|-0.0884||||0.5655|TWO_SIDED|95.0|-0.39|0.2132|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2132|-0.3900|0.5655
71904594|NCT04047121|143330614|SUPERIORITY||Odds Ratio (OR)|0.1809||||0.4044|TWO_SIDED|95.0|-0.2444|0.6062|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.6062|-0.2444|0.4044
71904595|NCT04047121|143330615|SUPERIORITY|||||||0.0104|||||||t-test, 2 sided|||||||0.0104
71904596|NCT04047121|143330615|SUPERIORITY|||||||0.5949|||||||t-test, 2 sided|||||||0.5949
71904597|NCT04047121|143330615|SUPERIORITY|||||||0.0801|||||||t-test, 2 sided|||||||0.0801
71904598|NCT04047121|143330615|SUPERIORITY||Odds Ratio (OR)|-3.7075||||0.0072|TWO_SIDED|95.0|-6.411|-1.004|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-1.0040|-6.4110|0.0072
71904599|NCT04047121|143330615|SUPERIORITY||Odds Ratio (OR)|-1.4296||||0.5406|TWO_SIDED|95.0|-6.008|3.1489|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.1489|-6.0080|0.5406
71904600|NCT04047121|143330615|SUPERIORITY||Odds Ratio (OR)|-0.3527||||0.8603|TWO_SIDED|95.0|-4.279|3.5737|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.5737|-4.2790|0.8603
71853927|NCT04748445|143221953|OTHER||Slope|0.000376|STANDARD_ERROR_OF_MEAN|7.531||0.9603|TWO_SIDED|90.0|-0.0121|0.01286|||Mixed Models Analysis|||READ\_MFCC std 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01286|-0.01210|0.9603
71853928|NCT04748445|143221953|OTHER||Slope|-0.002185|STANDARD_ERROR_OF_MEAN|5.703||0.7022|TWO_SIDED|90.0|-0.01164|0.007265|||Mixed Models Analysis|||READ\_MFCC std 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.007265|-0.01164|0.7022
71853929|NCT04748445|143221953|OTHER||Slope|0.007716|STANDARD_ERROR_OF_MEAN|5.746||0.1818|TWO_SIDED|90.0|-0.001806|0.01724|||Mixed Models Analysis|||READ\_MFCC std 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.01724|-0.001806|0.1818
71853930|NCT04748445|143221953|OTHER||Slope|-0.004019|STANDARD_ERROR_OF_MEAN|6.419||0.5324|TWO_SIDED|90.0|-0.01466|0.006618|||Mixed Models Analysis|||READ\_MFCC std 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.006618|-0.01466|0.5324
71853931|NCT04748445|143221953|OTHER||Slope|0.005103|STANDARD_ERROR_OF_MEAN|2.737||0.8524|TWO_SIDED|90.0|-0.04025|0.05046|||Mixed Models Analysis|||READ\_SNR (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.05046|-0.04025|0.8524
71853932|NCT04748445|143221954|OTHER||Slope|2.975|STANDARD_ERROR_OF_MEAN|3.383||0.3809|TWO_SIDED|90.0|-2.631|8.58|||Mixed Models Analysis|||EE\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4.||8.580|-2.631|0.3809
71853933|NCT04748445|143221954|OTHER||Slope|-0.005601|STANDARD_ERROR_OF_MEAN|2.751||0.0438|TWO_SIDED|90.0|-0.01016|-0.001043|||Mixed Models Analysis|||EE\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3.||-0.001043|-0.01016|0.0438
71853934|NCT04748445|143221954|OTHER||Slope|4.12|STANDARD_ERROR_OF_MEAN|1.464||0.0057|TWO_SIDED|90.0|1.694|6.546|||Mixed Models Analysis|||EE\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||6.546|1.694|0.0057
71853935|NCT04748445|143221954|OTHER||Slope|-3.067|STANDARD_ERROR_OF_MEAN|1.053||0.0042|TWO_SIDED|90.0|-4.811|-1.323|||Mixed Models Analysis|||EE\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3.||-1.323|-4.811|0.0042
71853936|NCT04748445|143221954|OTHER||Slope|2.78|STANDARD_ERROR_OF_MEAN|9.751||0.0051|TWO_SIDED|90.0|1.164|4.396|||Mixed Models Analysis|||EE\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and estimated value it was 10\^-3. For dispersion value it was 10\^-4).||4.396|1.164|0.0051
71853937|NCT04748445|143221954|OTHER||Slope|-1.324|STANDARD_ERROR_OF_MEAN|8.289||0.1128|TWO_SIDED|90.0|-2.698|4.973|||Mixed Models Analysis|||EE\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit and estimated value it was 10\^-3. For upper limit it was 10\^-5 and for dispersion value it was 10\^-4).||4.973|-2.698|0.1128
71904601|NCT04047121|143330616|SUPERIORITY|||||||0.6344|||||||t-test, 2 sided|||||||0.6344
71904602|NCT04047121|143330616|SUPERIORITY|||||||0.3037|||||||t-test, 2 sided|||||||0.3037
71904603|NCT04047121|143330616|SUPERIORITY|||||||0.1344|||||||t-test, 2 sided|||||||0.1344
71904604|NCT04047121|143330616|SUPERIORITY||Odds Ratio (OR)|1.2586||||0.5092|TWO_SIDED|95.0|-2.4787|4.9958|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||4.9958|-2.4787|0.5092
71904605|NCT04047121|143330616|SUPERIORITY||Odds Ratio (OR)|-0.7696||||0.8047|TWO_SIDED|95.0|-6.8683|5.3292|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.3292|-6.8683|0.8047
71904606|NCT04047121|143330616|SUPERIORITY||Odds Ratio (OR)|0.094||||0.9757|TWO_SIDED|95.0|-5.9628|6.1507|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.1507|-5.9628|0.9757
71904607|NCT04047121|143330617|SUPERIORITY|||||||0.0839|||||||t-test, 2 sided|||||||0.0839
71904608|NCT04047121|143330617|SUPERIORITY|||||||0.9577|||||||t-test, 2 sided|||||||0.9577
71904609|NCT04047121|143330617|SUPERIORITY|||||||0.9497|||||||t-test, 2 sided|||||||0.9497
71904610|NCT04047121|143330617|SUPERIORITY||Odds Ratio (OR)|-0.031||||0.4873|TWO_SIDED|95.0|-0.1185|0.0565|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0565|-0.1185|0.4873
71680689|NCT00001656|142879649|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||ANCOVA|||Analysis of covariance with baseline score as covariate||||0.72
71853938|NCT04748445|143221954|OTHER||Slope|-0.0002606|STANDARD_ERROR_OF_MEAN|9.707||0.7888|TWO_SIDED|90.0|-0.001869|0.001348|||Mixed Models Analysis|||EE\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001348|-0.001869|0.7888
71904611|NCT04047121|143330617|SUPERIORITY||Odds Ratio (OR)|-0.0312||||0.678|TWO_SIDED|95.0|-0.1783|0.1159|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.1159|-0.1783|0.6780
71904612|NCT04047121|143330617|SUPERIORITY||Odds Ratio (OR)|0.0099||||0.9327|TWO_SIDED|95.0|-0.2207|0.2406|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.2406|-0.2207|0.9327
71904613|NCT04047121|143330618|SUPERIORITY|||||||0.0021|||||||t-test, 2 sided|||||||0.0021
71904614|NCT04047121|143330618|SUPERIORITY|||||||0.5396|||||||t-test, 2 sided|||||||0.5396
71904615|NCT04047121|143330618|SUPERIORITY|||||||0.6121|||||||t-test, 2 sided|||||||0.6121
71904616|NCT04047121|143330618|SUPERIORITY||Odds Ratio (OR)|-0.1895||||0.0303|TWO_SIDED|95.0|-0.361|-0.0181|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||-0.0181|-0.3610|0.0303
71904617|NCT04047121|143330618|SUPERIORITY||Odds Ratio (OR)|-0.1901||||0.1807|TWO_SIDED|95.0|-0.4685|0.0883|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.0883|-0.4685|0.1807
71904618|NCT04047121|143330618|SUPERIORITY||Odds Ratio (OR)|0.1594||||0.7445|TWO_SIDED|95.0|-0.7991|1.1178|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1178|-0.7991|0.7445
71904619|NCT04047121|143330619|SUPERIORITY|||||||0.0035|||||||t-test, 2 sided|||||||0.0035
71904620|NCT04047121|143330619|SUPERIORITY|||||||0.504|||||||t-test, 2 sided|||||||0.5040
71904621|NCT04047121|143330619|SUPERIORITY|||||||0.1366|||||||t-test, 2 sided|||||||0.1366
71680690|NCT00001656|142879650|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate||||0.27
71904622|NCT04047121|143330619|SUPERIORITY||Odds Ratio (OR)|-3.4084||||0.082|TWO_SIDED|95.0|-7.2497|0.433|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.4330|-7.2497|0.0820
71904623|NCT04047121|143330619|SUPERIORITY||Odds Ratio (OR)|-1.5342||||0.5845|TWO_SIDED|95.0|-7.0336|3.9652|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||3.9652|-7.0336|0.5845
71904624|NCT04047121|143330619|SUPERIORITY||Odds Ratio (OR)|0.987||||0.7284|TWO_SIDED|95.0|-4.583|6.557|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||6.5570|-4.5830|0.7284
71904625|NCT04047121|143330620|SUPERIORITY|||||||0.1125|||||||t-test, 2 sided|||||||0.1125
71904626|NCT04047121|143330620|SUPERIORITY|||||||0.7156|||||||t-test, 2 sided|||||||0.7156
71904627|NCT04047121|143330620|SUPERIORITY|||||||0.2056|||||||t-test, 2 sided|||||||0.2056
71904628|NCT04047121|143330620|SUPERIORITY||Odds Ratio (OR)|-1.8061||||0.4288|TWO_SIDED|95.0|-6.2797|2.6675|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.6675|-6.2797|0.4288
71904629|NCT04047121|143330620|SUPERIORITY||Odds Ratio (OR)|-1.6946||||0.6303|TWO_SIDED|95.0|-8.5962|5.2069|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.2069|-8.5962|0.6303
71904630|NCT04047121|143330620|SUPERIORITY||Odds Ratio (OR)|-0.9873||||0.7477|TWO_SIDED|95.0|-7.0028|5.0281|||Regression, Linear|||To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||5.0281|-7.0028|0.7477
71904631|NCT04047121|143330621|SUPERIORITY|||||||0.3919|||||||t-test, 2 sided|||||||0.3919
71904632|NCT04047121|143330621|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71904633|NCT04047121|143330621|SUPERIORITY|||||||0.0193|||||||t-test, 2 sided|||||||0.0193
71904634|NCT04047121|143330621|SUPERIORITY||Cost Ratio|1.2232||||0.057|TWO_SIDED|95.0|0.994|1.5053|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a generalized linear model (GLM). Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.5053|0.9940|0.0570
71904635|NCT04047121|143330621|SUPERIORITY||Cost Ratio|1.8479|||<|0.0001|TWO_SIDED|95.0|1.4378|2.3749|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||2.3749|1.4378|<0.0001
71904636|NCT04047121|143330621|SUPERIORITY||Cost Ratio|1.1868||||0.0924|TWO_SIDED|95.0|0.9722|1.4487|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.4487|0.9722|0.0924
71904637|NCT04047121|143330622|SUPERIORITY|||||||0.6184|||||||t-test, 2 sided|||||||0.6184
71904638|NCT04047121|143330622|SUPERIORITY|||||||0.1952|||||||t-test, 2 sided|||||||0.1952
71904639|NCT04047121|143330622|SUPERIORITY|||||||0.1638|||||||t-test, 2 sided|||||||0.1638
71904640|NCT04047121|143330622|SUPERIORITY||Cost Ratio|0.9773||||0.6732|TWO_SIDED|95.0|0.8782|1.0875|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0875|0.8782|0.6732
71921897|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-17.2|STANDARD_ERROR_OF_MEAN|5.9|||TWO_SIDED|95.0|-29.5|-5.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7 postdose AM 4 hour||-5.0|-29.5|
71853939|NCT04748445|143221954|OTHER||Slope|-0.0005071|STANDARD_ERROR_OF_MEAN|7.593||0.5055|TWO_SIDED|90.0|-0.001765|0.0007512|||Mixed Models Analysis|||EE\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007512|-0.001765|0.5055
71853940|NCT04748445|143221954|OTHER||Slope|0.0003067|STANDARD_ERROR_OF_MEAN|6.273||0.6257|TWO_SIDED|90.0|-0.0007328|0.001346|||Mixed Models Analysis|||EE\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001346|-0.0007328|0.6257
71853941|NCT04748445|143221954|OTHER||Slope|-0.001649|STANDARD_ERROR_OF_MEAN|7.998||0.0413|TWO_SIDED|90.0|-0.002974|-0.0003238|||Mixed Models Analysis|||EE\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0003238|-0.002974|0.0413
71853942|NCT04748445|143221954|OTHER||Slope|0.0008236|STANDARD_ERROR_OF_MEAN|7.053||0.2451|TWO_SIDED|90.0|-0.0003452|0.001992|||Mixed Models Analysis|||EE\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001992|-0.0003452|0.2451
71853943|NCT04748445|143221954|OTHER||Slope|-0.000292|STANDARD_ERROR_OF_MEAN|6.839||0.6702|TWO_SIDED|90.0|-0.001425|0.0008413|||Mixed Models Analysis|||EE\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008413|-0.001425|0.6702
71853944|NCT04748445|143221954|OTHER||Slope|-0.0003363|STANDARD_ERROR_OF_MEAN|6.312||0.5951|TWO_SIDED|90.0|-0.001382|0.0007097|||Mixed Models Analysis|||EE\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007097|-0.001382|0.5951
71853945|NCT04748445|143221954|OTHER||Slope|0.0007281|STANDARD_ERROR_OF_MEAN|5.677||0.202|TWO_SIDED|90.0|-0.0002126|0.001669|||Mixed Models Analysis|||EE\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001669|-0.0002126|0.2020
71853946|NCT04748445|143221954|OTHER||Slope|0.0005153|STANDARD_ERROR_OF_MEAN|1.523||0.7356|TWO_SIDED|90.0|-0.002008|0.003038|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003038|-0.002008|0.7356
71904641|NCT04047121|143330622|SUPERIORITY||Cost Ratio|0.9629||||0.6345|TWO_SIDED|95.0|0.824|1.1253|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1253|0.8240|0.6345
71904642|NCT04047121|143330622|SUPERIORITY||Cost Ratio|0.8327||||0.0029|TWO_SIDED|95.0|0.738|0.9395|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9395|0.7380|0.0029
71904643|NCT04047121|143330623|SUPERIORITY|||||||0.3087|||||||t-test, 2 sided|||||||0.3087
71904644|NCT04047121|143330623|SUPERIORITY|||||||0.0003|||||||t-test, 2 sided|||||||0.0003
71904645|NCT04047121|143330623|SUPERIORITY|||||||0.0647|||||||t-test, 2 sided|||||||0.0647
71904646|NCT04047121|143330623|SUPERIORITY||Cost Ratio|0.9762||||0.7684|TWO_SIDED|95.0|0.8316|1.146|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1460|0.8316|0.7684
71904647|NCT04047121|143330623|SUPERIORITY||Cost Ratio|1.3862||||0.0012|TWO_SIDED|95.0|1.1379|1.6886|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.6886|1.1379|0.0012
71904648|NCT04047121|143330623|SUPERIORITY||Cost Ratio|1.0065||||0.9422|TWO_SIDED|95.0|0.8452|1.1985|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.1985|0.8452|0.9422
71904649|NCT04047121|143330624|SUPERIORITY|||||||0.0421|||||||t-test, 2 sided|||||||0.0421
71853947|NCT04748445|143221954|OTHER||Slope|-0.00133|STANDARD_ERROR_OF_MEAN|6.782||0.0522|TWO_SIDED|90.0|-0.002453|-0.0002057|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002057|-0.002453|0.0522
71853948|NCT04748445|143221954|OTHER||Slope|-0.000156|STANDARD_ERROR_OF_MEAN|6.763||0.818|TWO_SIDED|90.0|-0.001277|0.0009647|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0009647|-0.001277|0.8180
71853949|NCT04748445|143221954|OTHER||Slope|-0.0000971|STANDARD_ERROR_OF_MEAN|6.18||0.8754|TWO_SIDED|90.0|-0.001121|0.000927|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4.||0.0009270|-0.001121|0.8754
71904650|NCT04047121|143330624|SUPERIORITY|||||||0.8137|||||||t-test, 2 sided|||||||0.8137
71904651|NCT04047121|143330624|SUPERIORITY|||||||0.9416|||||||t-test, 2 sided|||||||0.9416
71904652|NCT04047121|143330624|SUPERIORITY||Cost Ratio|0.9515||||0.319|TWO_SIDED|95.0|0.8628|1.0493|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0493|0.8628|0.3190
71680691|NCT00001656|142879651|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANCOVA|Covariate is baseline score||||||0.11
71680692|NCT00001656|142879652|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
71680693|NCT00001656|142879653|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
71853950|NCT04748445|143221954|OTHER||Slope|0.000452|STANDARD_ERROR_OF_MEAN|5.576||0.4192|TWO_SIDED|90.0|-0.0004721|0.001376|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001376|-0.0004721|0.4192
71853951|NCT04748445|143221954|OTHER||Slope|-0.0001528|STANDARD_ERROR_OF_MEAN|5.586||0.7849|TWO_SIDED|90.0|-0.001079|0.0007729|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007729|-0.001079|0.7849
71853952|NCT04748445|143221954|OTHER||Slope|-5.254|STANDARD_ERROR_OF_MEAN|4.217||0.901|TWO_SIDED|90.0|-7.513|6.463|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-4. For estimated value it was 10\^-5).||6.463|-7.513|0.9010
71853953|NCT04748445|143221954|OTHER||Slope|-0.0004591|STANDARD_ERROR_OF_MEAN|3.83||0.2329|TWO_SIDED|90.0|-0.001094|0.0001755|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001755|-0.001094|0.2329
71853954|NCT04748445|143221954|OTHER||Slope|0.0007046|STANDARD_ERROR_OF_MEAN|3.687||0.0583|TWO_SIDED|90.0|0.00009366|0.001315|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|0.00009366|0.0583
71853955|NCT04748445|143221954|OTHER||Slope|-1.564|STANDARD_ERROR_OF_MEAN|3.606||0.6654|TWO_SIDED|90.0|-7.54|4.413|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||4.413|-7.540|0.6654
71853956|NCT04748445|143221954|OTHER||Slope|0.00006573|STANDARD_ERROR_OF_MEAN|2.81||0.8154|TWO_SIDED|90.0|-0.0003998|0.0005313|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005313|-0.0003998|0.8154
71853957|NCT04748445|143221954|OTHER||Slope|-0.0004071|STANDARD_ERROR_OF_MEAN|3.664||0.2687|TWO_SIDED|90.0|-0.001014|0.0002001|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002001|-0.001014|0.2687
71853958|NCT04748445|143221954|OTHER||Slope|2.799|STANDARD_ERROR_OF_MEAN|3.317||0.4005|TWO_SIDED|90.0|-2.698|8.296|||Mixed Models Analysis|||EE\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.296|-2.698|0.4005
71853959|NCT04748445|143221954|OTHER||Slope|1.123|STANDARD_ERROR_OF_MEAN|1.676||0.504|TWO_SIDED|90.0|-1.654|3.901|||Mixed Models Analysis|||MM\_Coefficient of Variation F0 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.901|-1.654|0.5040
71853960|NCT04748445|143221954|OTHER||Slope|0.00007586|STANDARD_ERROR_OF_MEAN|2.882||0.979|TWO_SIDED|90.0|-0.004701|0.004852|||Mixed Models Analysis|||MM\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.004852|-0.004701|0.9790
71904653|NCT04047121|143330624|SUPERIORITY||Cost Ratio|0.8991||||0.1368|TWO_SIDED|95.0|0.7815|1.0343|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||1.0343|0.7815|0.1368
71680694|NCT00001656|142879655|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.73
71680695|NCT00640653|142879676|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.03|TWO_SIDED|95.0|0.48|0.96||The significance criterion was set at alpha = .05.|generalized linear regression|Log link was specified|Treatment was coded as 1 vs health control coded as 0.|With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.||0.96|0.48|.03
71853961|NCT04748445|143221954|OTHER||Slope|0.0008249|STANDARD_ERROR_OF_MEAN|1.815||0.6503|TWO_SIDED|90.0|-0.002183|0.003833|||Mixed Models Analysis|||MM\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003833|-0.002183|0.6503
71853962|NCT04748445|143221954|OTHER||Slope|-1.188|STANDARD_ERROR_OF_MEAN|1.322||0.3705|TWO_SIDED|90.0|-3.379|1.003|||Mixed Models Analysis|||MM\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||1.003|-3.379|0.3705
71853963|NCT04748445|143221954|OTHER||Slope|-0.0007258|STANDARD_ERROR_OF_MEAN|1.101||0.5111|TWO_SIDED|90.0|-0.002551|0.001099|||Mixed Models Analysis|||MM\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.001099|-0.002551|0.5111
71853964|NCT04748445|143221954|OTHER||Slope|-0.001326|STANDARD_ERROR_OF_MEAN|7.555||0.0816|TWO_SIDED|90.0|-0.002578|-0.0000744|||Mixed Models Analysis|||MM\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0000744|-0.002578|0.0816
71853965|NCT04748445|143221954|OTHER||Slope|0.0005502|STANDARD_ERROR_OF_MEAN|1.056||0.6034|TWO_SIDED|90.0|-0.0012|0.002301|||Mixed Models Analysis|||MM\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.002301|-0.001200|0.6034
71853966|NCT04748445|143221954|OTHER||Slope|-0.0004691|STANDARD_ERROR_OF_MEAN|7.305||0.522|TWO_SIDED|90.0|-0.00168|0.0007415|||Mixed Models Analysis|||MM\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0007415|-0.001680|0.5220
71853967|NCT04748445|143221954|OTHER||Slope|-0.00153|STANDARD_ERROR_OF_MEAN|7.82||0.0526|TWO_SIDED|90.0|-0.002826|-0.0002344|||Mixed Models Analysis|||MM\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002344|-0.002826|0.0526
71853968|NCT04748445|143221954|OTHER||Slope|0.0004166|STANDARD_ERROR_OF_MEAN|7.294||0.5689|TWO_SIDED|90.0|-0.000792|0.001625|||Mixed Models Analysis|||MM\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001625|-0.0007920|0.5689
71853969|NCT04748445|143221954|OTHER||Slope|-0.002112|STANDARD_ERROR_OF_MEAN|7.299||0.0045|TWO_SIDED|90.0|-0.003321|-0.000902|||Mixed Models Analysis|||MM\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0009020|-0.003321|0.0045
71853970|NCT04748445|143221954|OTHER||Slope|-0.0007706|STANDARD_ERROR_OF_MEAN|7.494||0.3058|TWO_SIDED|90.0|-0.002013|0.0004713|||Mixed Models Analysis|||MM\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0004713|-0.002013|0.3058
71853971|NCT04748445|143221954|OTHER||Slope|0.0002388|STANDARD_ERROR_OF_MEAN|6.494||0.7137|TWO_SIDED|90.0|-0.0008374|0.001315|||Mixed Models Analysis|||MM\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001315|-0.0008374|0.7137
71853972|NCT04748445|143221954|OTHER||Slope|0.0002121|STANDARD_ERROR_OF_MEAN|6.877||0.7583|TWO_SIDED|90.0|-0.0009275|0.001352|||Mixed Models Analysis|||MM\_MFCC 1st order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001352|-0.0009275|0.7583
71853973|NCT04748445|143221954|OTHER||Slope|-2.784|STANDARD_ERROR_OF_MEAN|1.667||0.0974|TWO_SIDED|90.0|-5.547|-2.155|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit it was 10\^-5. For lower limit, estimated value and dispersion value it was 10\^-3).||-2.155|-5.547|0.0974
71853974|NCT04748445|143221954|OTHER||Slope|-1.368|STANDARD_ERROR_OF_MEAN|9.117||0.881|TWO_SIDED|90.0|-1.648|1.374|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and lower limit it was 10\^-3. For estimated value and dispersion value it was 10\^-4).||1.374|-1.648|0.8810
71822048|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-6.4|-2.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.4|-6.4|<0.001
71853975|NCT04748445|143221954|OTHER||Slope|-0.001551|STANDARD_ERROR_OF_MEAN|6.294||0.0151|TWO_SIDED|90.0|-0.002594|-0.0005077|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0005077|-0.002594|0.0151
71853976|NCT04748445|143221954|OTHER||Slope|0.00184|STANDARD_ERROR_OF_MEAN|7.343||0.0135|TWO_SIDED|90.0|0.0006233|0.003057|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.003057|0.0006233|0.0135
71853977|NCT04748445|143221954|OTHER||Slope|0.00129|STANDARD_ERROR_OF_MEAN|5.029||0.0115|TWO_SIDED|90.0|0.0004563|0.002123|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002123|0.0004563|0.0115
71853978|NCT04748445|143221954|OTHER||Slope|-0.0001473|STANDARD_ERROR_OF_MEAN|5.891||0.8029|TWO_SIDED|90.0|-0.001123|0.0008288|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0008288|-0.001123|0.8029
71853979|NCT04748445|143221954|OTHER||Slope|-0.0005556|STANDARD_ERROR_OF_MEAN|4.647||0.2342|TWO_SIDED|90.0|-0.001326|0.0002146|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002146|-0.001326|0.2342
71853980|NCT04748445|143221954|OTHER||Slope|0.001128|STANDARD_ERROR_OF_MEAN|5.339||0.0366|TWO_SIDED|90.0|0.0002436|0.002013|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.002013|0.0002436|0.0366
71853981|NCT04748445|143221954|OTHER||Slope|-0.0003297|STANDARD_ERROR_OF_MEAN|5.134||0.522|TWO_SIDED|90.0|-0.00118|0.0005212|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005212|-0.001180|0.5220
71853982|NCT04748445|143221954|OTHER||Slope|-2.104|STANDARD_ERROR_OF_MEAN|3.528||0.552|TWO_SIDED|90.0|-7.95|3.742|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||3.742|-7.950|0.5520
71853983|NCT04748445|143221954|OTHER||Slope|0.0005126|STANDARD_ERROR_OF_MEAN|4.289||0.2343|TWO_SIDED|90.0|-0.0001981|0.001223|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For ldispersion value it was 10\^-4).||0.001223|-0.0001981|0.2343
71853984|NCT04748445|143221954|OTHER||Slope|2.703|STANDARD_ERROR_OF_MEAN|4.094||0.5103|TWO_SIDED|90.0|-4.081|9.487|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||9.487|-4.081|0.5103
71921898|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|6.2|||TWO_SIDED|95.0|-24.4|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||1.1|-24.4|
71822049|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-7.7|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.7|<0.001
71822050|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|95.0|-8.9|-5.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.6|-8.9|<0.001
71822051|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
71822052|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-5.7|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-7.8|-3.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.7|-7.8|<0.001
71822053|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|-7.3|-4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.4|-7.3|<0.001
71822054|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.1|-2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-6.1|<0.001
71822055|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|95.0|-6.8|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-6.8|<0.001
71822056|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-5.3|-2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-5.3|<0.001
71822057|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.3|-1.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.3|-4.3|<0.001
71822058|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-4.4|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.4|<0.001
71822059|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.4|-1.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.1|-3.4|<0.001
71822060|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.71||0.36|TWO_SIDED|95.0|-2.0|0.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.8|-2.0|0.36
71853985|NCT04748445|143221954|OTHER||Slope|-0.000202|STANDARD_ERROR_OF_MEAN|5.334||0.7056|TWO_SIDED|90.0|-0.001086|0.0006819|||Mixed Models Analysis|||MM\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006819|-0.001086|0.7056
71853986|NCT04748445|143221954|OTHER||Slope|-2.66|STANDARD_ERROR_OF_MEAN|9.22||0.0046|TWO_SIDED|90.0|-4.188|-1.132|||Mixed Models Analysis|||READ\_MFCC 1st order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||-1.132|-4.188|0.0046
71853987|NCT04748445|143221954|OTHER||Slope|0.000649|STANDARD_ERROR_OF_MEAN|4.448||0.1471|TWO_SIDED|90.0|-0.0000881|0.001386|||Mixed Models Analysis|||READ\_MFCC 1st order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.001386|-0.0000881|0.1471
71853988|NCT04748445|143221954|OTHER||Slope|1.355|STANDARD_ERROR_OF_MEAN|3.323||0.6842|TWO_SIDED|90.0|-4.152|6.862|||Mixed Models Analysis|||READ\_MFCC 1st order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.862|-4.152|0.6842
71853989|NCT04748445|143221954|OTHER||Slope|0.00007664|STANDARD_ERROR_OF_MEAN|2.574||0.7664|TWO_SIDED|90.0|-0.0003499|0.0005032|||Mixed Models Analysis|||READ\_MFCC 1st order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0005032|-0.0003499|0.7664
71853990|NCT04748445|143221954|OTHER||Slope|-1.708|STANDARD_ERROR_OF_MEAN|2.028||0.4015|TWO_SIDED|90.0|-5.069|1.654|||Mixed Models Analysis|||READ\_MFCC 1st order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||1.654|-5.069|0.4015
71853991|NCT04748445|143221954|OTHER||Slope|2.51|STANDARD_ERROR_OF_MEAN|1.904||0.1897|TWO_SIDED|90.0|-6.446|5.665|||Mixed Models Analysis|||READ\_MFCC 1st order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.665|-6.446|0.1897
71853992|NCT04748445|143221954|OTHER||Slope|2.393|STANDARD_ERROR_OF_MEAN|1.627||0.1439|TWO_SIDED|90.0|-3.035|5.09|||Mixed Models Analysis|||READ\_MFCC 1st order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||5.090|-3.035|0.1439
71853993|NCT04748445|143221954|OTHER||Slope|4.111|STANDARD_ERROR_OF_MEAN|1.553||0.0092|TWO_SIDED|90.0|1.537|6.685|||Mixed Models Analysis|||READ\_MFCC 1st order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||6.685|1.537|0.0092
71853994|NCT04748445|143221954|OTHER||Slope|-0.0000415|STANDARD_ERROR_OF_MEAN|1.134||0.715|TWO_SIDED|90.0|-0.0002294|0.0001464|||Mixed Models Analysis|||READ\_MFCC 1st order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0001464|-0.0002294|0.7150
71853995|NCT04748445|143221954|OTHER||Slope|1.593|STANDARD_ERROR_OF_MEAN|1.291||0.2194|TWO_SIDED|90.0|-5.457|3.731|||Mixed Models Analysis|||READ\_MFCC 1st order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.731|-5.457|0.2194
71853996|NCT04748445|143221954|OTHER||Slope|0.0001893|STANDARD_ERROR_OF_MEAN|9.442||0.0471|TWO_SIDED|90.0|0.00003283|0.0003458|||Mixed Models Analysis|||READ\_MFCC 1st order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003458|0.00003283|0.0471
71853997|NCT04748445|143221954|OTHER||Slope|0.000138|STANDARD_ERROR_OF_MEAN|6.614||0.039|TWO_SIDED|90.0|0.0000284|0.0002476|||Mixed Models Analysis|||READ\_MFCC 1st order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002476|0.00002840|0.0390
71853998|NCT04748445|143221954|OTHER||Slope|1.166|STANDARD_ERROR_OF_MEAN|1.04||0.2645|TWO_SIDED|90.0|-5.579|2.89|||Mixed Models Analysis|||READ\_MFCC 1st order delta 13 (The statistical data given below have (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||2.890|-5.579|0.2645
71853999|NCT04748445|143221954|OTHER||Slope|-0.00119|STANDARD_ERROR_OF_MEAN|5.79||0.042|TWO_SIDED|90.0|-0.002149|-0.0002303|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 01 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||-0.0002303|-0.002149|0.0420
71854000|NCT04748445|143221954|OTHER||Slope|-4.504|STANDARD_ERROR_OF_MEAN|3.04||0.141|TWO_SIDED|90.0|-9.542|5.341|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 02 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-5).||5.341|-9.542|0.1410
71854001|NCT04748445|143221954|OTHER||Slope|2.968|STANDARD_ERROR_OF_MEAN|3.334||0.3751|TWO_SIDED|90.0|-2.557|8.492|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 03 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.492|-2.557|0.3751
71854002|NCT04748445|143221954|OTHER||Slope|-0.0000796|STANDARD_ERROR_OF_MEAN|2.101||0.7053|TWO_SIDED|90.0|-0.0004277|0.0002685|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 04 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0002685|-0.0004277|0.7053
71854003|NCT04748445|143221954|OTHER||Slope|5.075|STANDARD_ERROR_OF_MEAN|1.878||0.0078|TWO_SIDED|90.0|1.964|8.187|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 05 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-4).||8.187|1.964|0.0078
71854004|NCT04748445|143221954|OTHER||Slope|-1.88|STANDARD_ERROR_OF_MEAN|1.174||0.1119|TWO_SIDED|90.0|-3.826|6.611|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 06 (The statistical data given below have exponential factor in addition to the values mentioned. For lower limit, estimated value and dispersion value it was 10\^-4. For upper limit it was 10\^-6).||6.611|-3.826|0.1119
71854005|NCT04748445|143221954|OTHER||Slope|1.667|STANDARD_ERROR_OF_MEAN|1.164||0.1545|TWO_SIDED|90.0|-2.615|3.596|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 07 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^-4. For lower limit it was 10\^-5).||3.596|-2.615|0.1545
71854006|NCT04748445|143221954|OTHER||Slope|1.531|STANDARD_ERROR_OF_MEAN|9.552||0.1114|TWO_SIDED|90.0|-5.164|3.114|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 08 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit and estimated value it was 10\^-4. For lower limit it was 10\^-6 and for dispersion value it was 10\^-5).||3.114|-5.164|0.1114
71854007|NCT04748445|143221954|OTHER||Slope|0.0001989|STANDARD_ERROR_OF_MEAN|1.076||0.0668|TWO_SIDED|90.0|0.00002067|0.0003772|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 09 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0003772|0.00002067|0.0668
71854008|NCT04748445|143221954|OTHER||Slope|0.00005573|STANDARD_ERROR_OF_MEAN|9.318||0.5509|TWO_SIDED|90.0|-0.0000986|0.0002101|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 10 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0002101|-0.0000986|0.5509
71854009|NCT04748445|143221954|OTHER||Slope|0.00001774|STANDARD_ERROR_OF_MEAN|8.677||0.8383|TWO_SIDED|90.0|-0.000126|0.0001615|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 11 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001615|-0.0001260|0.8383
71854010|NCT04748445|143221954|OTHER||Slope|0.00007327|STANDARD_ERROR_OF_MEAN|6.63||0.2713|TWO_SIDED|90.0|-0.0000366|0.0001831|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 12 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0001831|-0.0000366|0.2713
71854011|NCT04748445|143221954|OTHER||Slope|0.0001534|STANDARD_ERROR_OF_MEAN|9.067||0.0931|TWO_SIDED|90.0|0.00000317|0.0003037|||Mixed Models Analysis|||READ\_MFCC 2nd order delta 13 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-5).||0.0003037|0.00000317|0.0931
71854012|NCT04748445|143221955|OTHER||Slope|-1.931|STANDARD_ERROR_OF_MEAN|3.554||0.5878|TWO_SIDED|90.0|-7.82|3.958|||Mixed Models Analysis|||EE\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, estimated value and dispersion value it was 10\^-3).||3.958|-7.820|0.5878
71854013|NCT04748445|143221955|OTHER||Slope|-1.479|STANDARD_ERROR_OF_MEAN|2.847||0.9587|TWO_SIDED|90.0|-4.866|4.57|||Mixed Models Analysis|||MM\_Entropy (The statistical data given below have exponential factor in addition to the values mentioned. For estimated value it was 10\^-4. For dispersion value, lower limit and upper limit it was 10\^-3).||4.570|-4.866|0.9587
71854014|NCT04748445|143221956|OTHER||Slope|-3.262|STANDARD_ERROR_OF_MEAN|4.487||0.9421|TWO_SIDED|90.0|-7.761|7.109|||Mixed Models Analysis|||EE\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^-1. For estimated value it was 10\^-2).||7.109|-7.761|0.9421
71854015|NCT04748445|143221956|OTHER||Slope|-0.06912|STANDARD_ERROR_OF_MEAN|5.997||0.9084|TWO_SIDED|90.0|-1.063|0.9247|||Mixed Models Analysis|||EE\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||0.9247|-1.063|0.9084
71854016|NCT04748445|143221956|OTHER||Slope|1.985|STANDARD_ERROR_OF_MEAN|1.23||0.8721|TWO_SIDED|90.0|-1.841|2.238|||Mixed Models Analysis|||EE\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit and dispersion value it was 10\^0. For estimated value it was 10\^-1).||2.238|-1.841|0.8721
71854017|NCT04748445|143221956|OTHER||Slope|0.6573|STANDARD_ERROR_OF_MEAN|2.191||0.7647|TWO_SIDED|90.0|-2.974|4.288|||Mixed Models Analysis|||EE\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.288|-2.974|0.7647
71854018|NCT04748445|143221956|OTHER||Slope|0.6504|STANDARD_ERROR_OF_MEAN|8.958||0.4692|TWO_SIDED|90.0|-0.8341|2.135|||Mixed Models Analysis|||EE\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.135|-0.8341|0.4692
71854019|NCT04748445|143221956|OTHER||Slope|-0.09459|STANDARD_ERROR_OF_MEAN|1.255||0.94|TWO_SIDED|90.0|-2.174|1.985|||Mixed Models Analysis|||EE\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.985|-2.174|0.9400
71854020|NCT04748445|143221956|OTHER||Slope|0.6945|STANDARD_ERROR_OF_MEAN|7.972||0.3853|TWO_SIDED|90.0|-0.6265|2.015|||Mixed Models Analysis|||MM\_Formant 1 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-1).||2.015|-0.6265|0.3853
71854021|NCT04748445|143221956|OTHER||Slope|0.02424|STANDARD_ERROR_OF_MEAN|1.021||0.9811|TWO_SIDED|90.0|-1.667|1.716|||Mixed Models Analysis|||MM\_Formant 1 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||1.716|-1.667|0.9811
71854022|NCT04748445|143221956|OTHER||Slope|-0.9256|STANDARD_ERROR_OF_MEAN|1.083||0.3944|TWO_SIDED|90.0|-2.72|0.869|||Mixed Models Analysis|||MM\_Formant 2 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||0.8690|-2.720|0.3944
71854023|NCT04748445|143221956|OTHER||Slope|0.935|STANDARD_ERROR_OF_MEAN|1.289||0.4696|TWO_SIDED|90.0|-1.201|3.071|||Mixed Models Analysis|||MM\_Formant 2 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||3.071|-1.201|0.4696
71854024|NCT04748445|143221956|OTHER||Slope|2.105|STANDARD_ERROR_OF_MEAN|1.231||0.0896|TWO_SIDED|90.0|0.06596|4.145|||Mixed Models Analysis|||MM\_Formant 3 (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^0).||4.145|0.06596|0.0896
71854025|NCT04748445|143221956|OTHER||Slope|1.664|STANDARD_ERROR_OF_MEAN|1.358||0.2227|TWO_SIDED|90.0|-5.864|3.915|||Mixed Models Analysis|||MM\_Formant 3 Bandwidth (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, estimated value and dispersion value it was 10\^0. For lower limit it was 10\^-1).||3.915|-5.864|0.2227
71854026|NCT04748445|143221957|OTHER||Slope|-4.024|STANDARD_ERROR_OF_MEAN|3.122||0.8977|TWO_SIDED|90.0|-5.577|4.772|||Mixed Models Analysis|||EE\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||4.772|-5.577|0.8977
71854027|NCT04748445|143221957|OTHER||Slope|-0.0006624|STANDARD_ERROR_OF_MEAN|7.961||0.407|TWO_SIDED|90.0|-0.001982|0.0006569|||Mixed Models Analysis|||MM\_Voiced Frames (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-4).||0.0006569|-0.001982|0.4070
71854028|NCT04748445|143221958|OTHER||Slope|0.0008654|STANDARD_ERROR_OF_MEAN|1.441||0.5491|TWO_SIDED|90.0|-0.001522|0.003253|||Mixed Models Analysis|||EE\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-3).||0.003253|-0.001522|0.5491
71854029|NCT04748445|143221958|OTHER||Slope|-2.206|STANDARD_ERROR_OF_MEAN|3.176||0.9447|TWO_SIDED|90.0|-5.483|5.042|||Mixed Models Analysis|||MM\_Jitter Local (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and dispersion value it was 10\^-3. For estimated value it was 10\^-4).||5.042|-5.483|0.9447
71854030|NCT04748445|143221959|OTHER||Slope|0.007567|STANDARD_ERROR_OF_MEAN|1.12||0.5004|TWO_SIDED|90.0|-0.01099|0.02612|||Mixed Models Analysis|||EE\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02612|-0.01099|0.5004
71854031|NCT04748445|143221959|OTHER||Slope|0.00606|STANDARD_ERROR_OF_MEAN|1.101||0.5831|TWO_SIDED|90.0|-0.01219|0.02431|||Mixed Models Analysis|||MM\_Shimmer Local (The statistical data given below have exponential factor in addition to the values mentioned. For dispersion value it was 10\^-2).||0.02431|-0.01219|0.5831
71854032|NCT04748445|143221960|OTHER||Slope|2.13|STANDARD_ERROR_OF_MEAN|3.211|<|0.0001|TWO_SIDED|90.0|1.598|2.662|||Mixed Models Analysis|||READ\_Speaking Rate (The statistical data given below have exponential factor in addition to the values mentioned. For upper limit, lower limit, and estimated value it was 10\^-2. For dispersion value it was 10\^-3).||2.662|1.598|<.0001
71854033|NCT02498418|143221977|EQUIVALENCE|Bioequivalence was demonstrated if 90% confidence interval (CI) of percentage difference between generic rifaximin 200 mg tablets and xifaxan 200 mg tablets was within the equivalence range (-20%, +20%).|Difference in percentage of participants|-0.0193|||||TWO_SIDED|90.0|-0.11|0.07||||||Bioequivalence was evaluated based on the PP analysis set using Z-test with Yates correction.||0.07|-0.11|
71854034|NCT02498418|143221980|SUPERIORITY||Difference in percentage of participants|-0.0195||||0.7899|TWO_SIDED|95.0|-0.09|0.13||Threshold of significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.13|-0.09|0.7899
71854035|NCT02498418|143221980|SUPERIORITY||Difference in percentage of participants|0.033||||0.5987|TWO_SIDED|95.0|-0.07|0.14||Threshold for significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates' correction.||0.14|-0.07|0.5987
71854036|NCT03042559|143221985|SUPERIORITY|||||||||||||a priori threshold for statistical significance is \<0.05.|Wilcoxon (Mann-Whitney)|||Data analysis was performed using SPSS Statistics Software version 24.0. We compared mean age (years), Body Mass Index (kg/m2) (BMI), pain duration, and the outcome measures at baseline in both groups at baseline using independent t-test when the distribution of the variable was approximately normal and Mann-Whitney test when the distribution was not normal. The distribution of qualitative variables (gender, affected leg) by group type was examined using Chi Square test.|a priori threshold for statistical significance is \<0.05.|||
71854037|NCT03042559|143221992|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71854038|NCT03866434|143222020|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LSmeans|64.225|||||TWO_SIDED|90.0|53.212|77.516|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the least squares (LS) mean difference in the log-transformed parameters back transformed to the original scale) and their 90 percent (%) confidence intervals (CI) were calculated.||77.516|53.212|
71854039|NCT03866434|143222021|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|%ratio of Geometric LeastSquare(LS)means|82.203|||||TWO_SIDED|90.0|71.501|94.507|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||94.507|71.501|
71854040|NCT03866434|143222022|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.705|||||TWO_SIDED|90.0|64.555|84.152|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||84.152|64.555|
71854041|NCT03866434|143222023|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|85.527|||||TWO_SIDED|90.0|78.163|93.584|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||93.584|78.163|
71854042|NCT03866434|143222024|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.007|||||TWO_SIDED|90.0|62.528|85.243|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||85.243|62.528|
71904654|NCT04047121|143330624|SUPERIORITY||Cost Ratio|0.8514||||0.0231|TWO_SIDED|95.0|0.7411|0.9782|||Regression, Linear||Since health care costs were skewed, hence estimated cost was modeled using a GLM. Coefficients from a generalized linear model were estimated as cost ratios.|To control and remove the possible influence of the independent variables (like treatment cohort, demographic and clinical characteristics of interest, etc. and clinical judgement) on the outcome measure, multivariable analysis was performed.||0.9782|0.7411|0.0231
71904655|NCT02604810|143330630|NON_INFERIORITY|Method of estimation = least-squares means based on analysis of variance (ANOVA) with a mixed-effect model. The lower bound of the 90% confidence interval (CI) for the geometric LSM ratio (SC/IV) of the primary PK endpoint of steady state AUC0-7 days for the PK population should be above 0.80.|Geometric least-squares mean ratio|1.04|||||TWO_SIDED|90.0|1.0|1.07||||||||1.07|1.00|
71904656|NCT02625324|143330633|SUPERIORITY||Event Rate|0.023|||<|0.0001|ONE_SIDED|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p \<16%, where p denotes the true event rate of primary study endpoint in the target population."||0.081||<0.0001
71904657|NCT00424528|143330656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as covariate and treatment group as fixed effect.||||||<0.001
71904658|NCT00424528|143330656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study Baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
71822061|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.72||0.009|TWO_SIDED|95.0|-3.3|-0.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.5|-3.3|0.009
71822062|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-4.5|-2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-4.5|<0.001
71822063|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.69||0.042|TWO_SIDED|95.0|-2.7|-0.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.1|-2.7|0.042
71822064|NCT02886728|143146003|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-3.7|-1.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-3.7|<0.001
71854043|NCT03866434|143222025|EQUIVALENCE|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|86.504|||||TWO_SIDED|90.0|78.462|95.371|||ANOVA|A 2-factor analysis of variance (ANOVA) model with fixed factors for treatment and participant was fitted to the natural logtransformed PK parameters.|This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole \[Day 8\] versus anagrelide alone \[Day 1\]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.||95.371|78.462|
71854044|NCT00385697|143222036|SUPERIORITY||Odds Ratio (OR)|0.963||||0.904|TWO_SIDED|95.0|0.521|1.779|||Mantel Haenszel|||||1.779|0.521|0.904
71854045|NCT00385697|143222036|SUPERIORITY||Odds Ratio (OR)|0.629||||0.222|TWO_SIDED|95.0|0.297|1.33|||Mantel Haenszel|||||1.330|0.297|0.222
71854046|NCT00385697|143222036|SUPERIORITY||Odds Ratio (OR)|1.054||||0.885|TWO_SIDED|95.0|0.521|2.129|||Mantel Haenszel|||||2.129|0.521|0.885
71854047|NCT00385697|143222038|SUPERIORITY||Mean Difference (Final Values)|0.061||||0.814|TWO_SIDED|95.0|-0.45|0.572|||ANCOVA|||||0.572|-0.450|0.814
71854048|NCT00385697|143222038|SUPERIORITY||Mean Difference (Final Values)|0.161||||0.593|TWO_SIDED|95.0|-0.433|0.755|||ANCOVA|||||0.755|-0.433|0.593
71854049|NCT00385697|143222038|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-0.594|0.513|||ANCOVA|||||0.513|-0.594|0.886
71854050|NCT00385697|143222040|SUPERIORITY||Mean Difference (Final Values)|0.047||||0.049|TWO_SIDED|95.0|0.0|0.093|||ANCOVA|||||0.093|0.000|0.049
71854051|NCT00385697|143222040|SUPERIORITY||Mean Difference (Final Values)|-0.002||||0.937|TWO_SIDED|95.0|-0.061|0.056|||ANCOVA|||||0.056|-0.061|0.937
71854052|NCT00385697|143222040|SUPERIORITY||Mean Difference (Final Values)|0.026||||0.382|TWO_SIDED|95.0|-0.032|0.084|||ANCOVA|||||0.084|-0.032|0.382
71854053|NCT00385697|143222042|SUPERIORITY||Odds Ratio (OR)|0.881||||0.775|TWO_SIDED|95.0|0.372|2.089|||Mantel Haenszel|||||2.089|0.372|0.775
71854054|NCT00385697|143222042|SUPERIORITY||Odds Ratio (OR)|0.628||||0.402|TWO_SIDED|95.0|0.212|1.861|||Mantel Haenszel|||||1.861|0.212|0.402
71854055|NCT00385697|143222042|SUPERIORITY||Odds Ratio (OR)|1.093||||0.859|TWO_SIDED|95.0|0.41|2.912|||Mantel Haenszel|||||2.912|0.410|0.859
71854056|NCT00385697|143222044|SUPERIORITY||Odds Ratio (OR)|1.265||||0.404|TWO_SIDED|95.0|0.727|2.2|||Mantel Haenszel|||||2.200|0.727|0.404
71854057|NCT00385697|143222044|SUPERIORITY||Odds Ratio (OR)|0.805||||0.528|TWO_SIDED|95.0|0.412|1.576|||Mantel Haenszel|||||1.576|0.412|0.528
71854058|NCT00385697|143222044|SUPERIORITY||Odds Ratio (OR)|1.133||||0.706|TWO_SIDED|95.0|0.594|2.164|||Mantel Haenszel|||||2.164|0.594|0.706
71854059|NCT00385697|143222046|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.872|TWO_SIDED|95.0|-0.455|0.536|||ANCOVA|||||0.536|-0.455|0.872
71854060|NCT00385697|143222046|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.979|TWO_SIDED|95.0|-0.581|0.556|||ANCOVA|||||0.556|-0.581|0.979
71854061|NCT00385697|143222046|SUPERIORITY||Mean Difference (Final Values)|-0.225||||0.4|TWO_SIDED|95.0|-0.75|0.301|||ANCOVA|||||0.301|-0.750|0.400
71854062|NCT01485991|143222048|SUPERIORITY_OR_OTHER||Difference in proportions|-1.1||||0.001|TWO_SIDED|95.0|-7.8|5.5||based on the asymptotic distribution of the generalized Cochran-Mantel-Haenszel statistic controlling for stratification factors, using a non-inferiority margin of 12 percent|Stratified Cochran-Mantel-Haenszel|||||5.5|-7.8|0.001
71854063|NCT04864236|143222066|EQUIVALENCE|We compared particle number counts between intervention and control groups using the Wilcoxon test. Analyses were conducted using IBM SPSS V28 and p-values \<0.05 were considered statistically significant.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854064|NCT04864236|143222067|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.073|||||||t-test, 1 sided|||||||0.073
71854065|NCT04864236|143222068|EQUIVALENCE|Patient characteristics and study variables were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.67|||||||t-test, 1 sided|||||||0.670
71854066|NCT04864236|143222069|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.167|||||||t-test, 1 sided|||||||0.167
71854067|NCT04864236|143222070|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.198|||||||t-test, 1 sided|||||||0.198
71854068|NCT04864236|143222071|EQUIVALENCE|Patient characteristics were summarized between groups using mean (SD) and formally compared using the t-test.||||||0.442|||||||t-test, 1 sided|||||||0.442
71854069|NCT01209936|143222209|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||||||0.87
71854070|NCT01209936|143222210|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71854071|NCT01209936|143222211|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71904659|NCT00424528|143330656|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Primary analysis:Group 2 vs 3. Key secondary analysis: Group 1 vs 3. Multiple comparisons for the analysis of the primary endpoint were controlled at the 5% level.|ANCOVA|Study baseline FEV1 as a covariate and treatment group as fixed effect.||||||<0.001
71854072|NCT00257556|143222314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045||||||95.0|-0.17|0.26|||||A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation|||0.260|-0.170|
71854073|NCT04839289|143222347|OTHER||||||>|0.05||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||>0.05
71854074|NCT04839289|143222347|OTHER||||||<|0.0167||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to .01666667 (.05/3)|t-test, 2 sided|||"Null hypothesis: Subjective ratings of sound quality would not be different between any of the three study hearing aids when measured with a validated sound quality questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.0167
71854075|NCT04839289|143222350|OTHER||||||<|0.01666667||||||When p-value is adjusted for multiple comparisons, the value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
71854076|NCT04839289|143222350|OTHER||||||<|0.01666667||||||When adjusted for multiple comparisons, the p-value must be \</= to .01666667 (.05/3).|t-test, 2 sided|||"Null hypothesis: Satisfaction with hearing aid performance and features would not be different between any of the three study hearing aids when measured with subjective hearing aid satisfaction questionnaire.~Analysis was done after all three home trials completed so all three sets of study devices could be compared."||||<.01666667
71854077|NCT02418819|143222357|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-1.9|STANDARD_ERROR_OF_MEAN|2.032||0.8243|ONE_SIDED|92.0|-4.78||||ANCOVA|One(1)-sided P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-4.78|0.8243
71854078|NCT02418819|143222357|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-2.14|STANDARD_ERROR_OF_MEAN|2.252||0.8277|ONE_SIDED|92.0|-5.33||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-5.33|0.8277
71904660|NCT00424528|143330657|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
71904661|NCT00424528|143330657|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
71904662|NCT00424528|143330658|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.001
71904663|NCT00424528|143330658|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||<0.001
71904664|NCT00424528|143330659|SUPERIORITY_OR_OTHER|||||||0.073||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.073
71904665|NCT00424528|143330659|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||||||0.050
71904666|NCT00424528|143330662|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANCOVA|Week 0 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0 comparisons||||0.060
71904667|NCT00424528|143330662|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0||||<0.001
71854079|NCT02418819|143222357|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-4.01|STANDARD_ERROR_OF_MEAN|1.902||0.981|ONE_SIDED|92.0|-6.7||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|||-6.70|0.9810
71854080|NCT02418819|143222358|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0129|STANDARD_ERROR_OF_MEAN|0.286||0.4821|ONE_SIDED|99.0|-0.6682||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.6682|0.4821
71854081|NCT02418819|143222358|SUPERIORITY_OR_OTHER||LSMean difference from placebo|-0.2974|STANDARD_ERROR_OF_MEAN|0.276||0.8576|ONE_SIDED|99.0|-0.9547||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.9547|0.8576
71854082|NCT02418819|143222358|SUPERIORITY_OR_OTHER||LSMean difference from placebo|0.0498|STANDARD_ERROR_OF_MEAN|0.2403||0.4182|ONE_SIDED|99.0|-0.5226||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|||-0.5226|0.4182
71904668|NCT00424528|143330662|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.004
71904669|NCT00424528|143330662|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons||||0.002
71904670|NCT00424528|143330665|SUPERIORITY_OR_OTHER|||||||0.206||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.206
71904671|NCT00424528|143330665|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.||||||0.025
71904672|NCT01313520|143330676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.1|||Constrained Longitudinal Data Analysis|||||-0.1|-0.4|<0.001
71904673|NCT01313520|143330677|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Fisher Exact|||||||0.048
71904674|NCT01313520|143330678|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||Fisher Exact|||||||0.011
71904675|NCT01313520|143330679|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Constrained longitudinal data analysis|||||||<0.0001
71904676|NCT01313520|143330680|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||van Elteren test|||||||0.001
71904677|NCT01313520|143330681|SUPERIORITY_OR_OTHER|||||||0.0005||95.0|||||van Elteren test|||||||0.0005
71680696|NCT02505334|142879681|SUPERIORITY|Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.|Treatment difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||ANCOVA|||Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.||-0.24|-0.55|<0.0001
71904678|NCT01313520|143330682|SUPERIORITY_OR_OTHER||Effect Size|1.4|||||TWO_SIDED|90.0|0.92|1.87||||||||1.87|0.92|
71904679|NCT01313520|143330683|SUPERIORITY_OR_OTHER||Effect Size|1.1|||||TWO_SIDED|90.0|0.64|1.55||||||||1.55|0.64|
71904680|NCT03736629|143330688|SUPERIORITY||Mean Difference (Net)|-0.67|STANDARD_ERROR_OF_MEAN|1.72||0.72|TWO_SIDED|95.0|-6.14|4.81|||t-test, 2 sided|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||4.81|-6.14|0.72
71904681|NCT03736629|143330689|SUPERIORITY||Mean Difference (Net)|-5.67||||0.59|TWO_SIDED|95.0|-35.98|24.65|||t-test, 2 sided||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.|||24.65|-35.98|0.59
71904682|NCT03736629|143330692|SUPERIORITY|||||||1|||||||Fisher Exact|||Study did not reach its accrual goal. Sample size is too small to draw any conclusions.||||1.0
71904683|NCT00967226|143330696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|STANDARD_DEVIATION|0.05||0.77|||||||t-test, 2 sided|||intention to treat analysis||||0.77
71904684|NCT01042613|143330716|SUPERIORITY_OR_OTHER||Difference of the Binomial Proportions|0.02||||0.851||95.0|||||Fisher Exact|||||||.851
71904685|NCT01042613|143330717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.105||95.0|||||Wilcoxon (Mann-Whitney)|||||||.105
71904686|NCT01042613|143330718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.8||95.0|||||Wilcoxon (Mann-Whitney)|||||||.8
71904687|NCT00487084|143330719|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Log Rank|||A sample of 56 was estimated to have an 80% power to detect a 30% difference in the proportion of subjects with continuing analgesia in the MCS versus the SCM groups when 50% of the subjects in the SCM had requested supplemental analgesia. 28 subjects was added to compare the influence of time of morphine and 2-chloroprocaine administration to lidocaine-morphine analgesia. The primary outcome was compared using Kaplan-Meier survival analysis and the log-rank test.||||0.006
71904688|NCT00487084|143330719|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Log Rank|||||||0.83
71904689|NCT00487084|143330719|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Log Rank|||||||0.009
71904690|NCT00487084|143330720|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
71904691|NCT00487084|143330720|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Kruskal-Wallis|||||||<0.05
71904692|NCT00487084|143330721|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
71904693|NCT00487084|143330721|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Chi-squared, Corrected|||||||0.01
71904694|NCT00487084|143330722|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Chi-squared, Corrected|||||||0.20
71904695|NCT02568345|143330723|SUPERIORITY_OR_OTHER||isotonic regression functions through PA|2.2|||||TWO_SIDED|||||The isotonic regression functions through PAVA algorithm were used (pooled adjacent violators algorithm), to determine the ED90, and bootstrapping to calculate the respective 95% confidence interval with the statistical program R||||||||
71904696|NCT03209440|143330724|SUPERIORITY||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.73||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
71904697|NCT03209440|143330724|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|0.74||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
71904698|NCT03209440|143330725|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|0.49||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
71904699|NCT03209440|143330725|SUPERIORITY||Median Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.5||0.12|TWO_SIDED||||||Regression, Linear|||||||0.12
71904700|NCT03209440|143330726|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.72||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
71904701|NCT03209440|143330726|SUPERIORITY||Mean Difference (Net)|0.91|STANDARD_ERROR_OF_MEAN|0.73||0.21|TWO_SIDED||||||Regression, Linear|||||||0.21
71904702|NCT03209440|143330727|SUPERIORITY||Odds Ratio, log|1.0|STANDARD_ERROR_OF_MEAN|0.62||0.11|TWO_SIDED||||||Regression, Logistic|||||||0.11
71904703|NCT03209440|143330727|SUPERIORITY||Odds Ratio, log|0.96|STANDARD_ERROR_OF_MEAN|0.64||0.14|TWO_SIDED||||||Regression, Logistic|||||||0.14
71904704|NCT03209440|143330728|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.05
71680697|NCT02938949|142879751|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71680698|NCT02938949|142879752|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||> 0.20
71680699|NCT02938949|142879753|SUPERIORITY||||||>|0.2|||||||ANOVA|||||||>0.20
71680700|NCT01537068|142879861|SUPERIORITY_OR_OTHER||Test of Within-subjects effects|2.95||||0.09|TWO_SIDED||||||Mixed Models Analysis|Repeated Measures of ANOVA||||||0.09
71680701|NCT01537068|142879863|SUPERIORITY_OR_OTHER||Chi-squared|6.32||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
71854083|NCT00513292|143222372|SUPERIORITY_OR_OTHER||difference in percentages between arms|2.3||||0.7|TWO_SIDED|95.0|-9.3|13.9|||Chi-squared|||The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy||13.9|-9.3|.7
71904705|NCT03209440|143330728|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.18||0.46|TWO_SIDED||||||Regression, Linear|"The outcome variable was scored as 1= prolong life; treat everything to 4 = provide comfort care only."||||||0.46
71904706|NCT04348656|143330742|SUPERIORITY||Risk Ratio (RR)|1.16||||0.18|TWO_SIDED|95.0|0.94|1.43|||wald test|||||1.43|0.94|0.18
71680702|NCT00483704|142879864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.54|||<|0.001|TWO_SIDED|95.0|1.8|3.58|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.58|1.80|<0.001
71680703|NCT00483704|142879864|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.15|4.27|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.27|2.15|<0.001
71904707|NCT04348656|143330743|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.3|TWO_SIDED|95.0|0.89|1.47|||Regression, Cox|||||1.47|0.89|0.30
71854084|NCT00332488|143222446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.42|TWO_SIDED|95.0|-0.11|0.27|||ANCOVA|||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||0.27|-0.11|0.420
71680704|NCT00483704|142879865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.03|||<|0.001|TWO_SIDED|95.0|2.35|3.9|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.90|2.35|<0.001
71854085|NCT00332488|143222447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91|||<|0.001|TWO_SIDED|95.0|0.69|1.14|||ANCOVA|Type III||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate||1.14|0.69|< 0.001
71854086|NCT02983877|143222450|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
71854087|NCT02983877|143222451|SUPERIORITY||||||<|0.001|||||||ANOVA|3 degrees of freedom||||||<0.001
71680705|NCT00483704|142879865|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.001|TWO_SIDED|95.0|2.17|3.61|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|2.17|<0.001
71680706|NCT00483704|142879866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85|||<|0.001|TWO_SIDED|95.0|2.05|7.23|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||7.23|2.05|<0.001
71680707|NCT00483704|142879866|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.18|||<|0.001|TWO_SIDED|95.0|3.36|11.39|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||11.39|3.36|<0.001
71680708|NCT00483704|142879867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.001|TWO_SIDED|95.0|1.96|3.51|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.51|1.96|<0.001
71680709|NCT00483704|142879867|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.23|||<|0.001|TWO_SIDED|95.0|2.41|4.34|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.34|2.41|<0.001
71904708|NCT04348656|143330744|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.41|TWO_SIDED|95.0|-2.1|0.7|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||0.7|-2.1|0.41
71904709|NCT04348656|143330745|SUPERIORITY||Risk Ratio (RR)|1.12||||0.4|TWO_SIDED|95.0|0.86|1.46|||wald test|||||1.46|0.86|0.40
71904710|NCT04348656|143330746|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.22|TWO_SIDED|95.0|-0.3|1.7|||t-test, 2 sided|||||1.7|-0.3|0.22
71904711|NCT04348656|143330747|SUPERIORITY||Risk Ratio (RR)|0.83||||0.72|TWO_SIDED|95.0|0.31|2.27|||t-test, 2 sided|bootstrap estimates based on resampling process|bootstrap estimates based on resampling process|||2.27|0.31|0.72
71904712|NCT04348656|143330750|SUPERIORITY||Risk Ratio (RR)|1.13||||0.33|TWO_SIDED|95.0|0.88|1.45|||wald test|||||1.45|0.88|0.33
71904713|NCT04348656|143330751|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.91|TWO_SIDED|95.0|0.76|1.35|||Regression, Cox|competing risk analysis|competing risk analysis|||1.35|0.76|0.91
71904714|NCT04348656|143330752|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.18|TWO_SIDED|95.0|0.8|1.04|||Regression, Cox|||||1.04|0.80|0.18
71904715|NCT04348656|143330753|SUPERIORITY||Risk Ratio (RR)|1.53||||0.03|TWO_SIDED|95.0|1.04|2.26|||wald test|||||2.26|1.04|0.03
71904716|NCT04348656|143330753|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.02|TWO_SIDED|95.0|1.08|2.69|||Regression, Cox|competing risk analysis|competing risk analysis|The cumulative incidence of Grade 3 and 4 serious AEs is described as a hazard ratio.||2.69|1.08|0.02
71904717|NCT04348656|143330755|SUPERIORITY||Risk Ratio (RR)|1.27||||0.03|TWO_SIDED|95.0|1.02|1.57|||wald test|||||1.57|1.02|0.03
71904718|NCT04348656|143330758|OTHER|Incremental cost per quality-adjusted life day gained (ICER)- this is a summary measure of the cost-effectiveness of the intervention, compared to the control group. This is calculated using the cost (derived from cost of the intervention and cost of hospital stay based on the payer's perspective) per patient and the quality-adjusted life days calculated using the EQ-5D-5L results.|ICER (CAD)|-44623.01|||||TWO_SIDED|95.0|-525369.24|436123.22|||||ICER is reported in Canadian dollars. 95% CI is calculated by 1000 bootstrap sampling using bias-corrected accelerated method.|||436123.22|-525369.24|
71904719|NCT03607838|143330771|SUPERIORITY||Mean Difference (Final Values)|-7.5|STANDARD_ERROR_OF_MEAN|3.35||0.0263|TWO_SIDED|95.0|-14.1|-0.9|||Mixed Models Analysis|||||-0.9|-14.1|0.0263
71904720|NCT03607838|143330772|SUPERIORITY||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|3.4||0.0558|TWO_SIDED|95.0|-13.2|0.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||0.2|-13.2|0.0558
71904721|NCT03607838|143330773|SUPERIORITY||Mean Difference (Final Values)|-25.8|STANDARD_ERROR_OF_MEAN|15.24||0.092|TWO_SIDED|95.0|-55.7|4.2||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||4.2|-55.7|0.0920
71904722|NCT03607838|143330774|SUPERIORITY||Mean Difference (Final Values)|-4.2|STANDARD_ERROR_OF_MEAN|1.95||0.0336|TWO_SIDED|95.0|-8.0|-0.3||To control family-wise error rate for multiple tests of the primary and key secondary endpoints, serial gatekeeping testing algorithm was used.|Mixed Models Analysis|||||-0.3|-8.0|0.0336
71904723|NCT02665364|143330912|SUPERIORITY||arithmetic mean|-30.2802|STANDARD_ERROR_OF_MEAN|5.2588|<|0.0001|TWO_SIDED|95.0|-40.6653|-19.8951|||ANCOVA|||The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.||-19.8951|-40.6653|< 0.0001
71904724|NCT02665364|143330913|SUPERIORITY||Odds Ratio (OR)|1.38||||0.34|TWO_SIDED|95.0|0.716|2.657|||Regression, Logistic|||Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.657|0.716|0.34
71904725|NCT02665364|143330914|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6243|TWO_SIDED|95.0|0.602|2.329|||Regression, Logistic|||The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.||2.329|0.602|0.6243
71904726|NCT02665364|143330915|SUPERIORITY|||||||0.0022|||||||Pearson's Chi-squared|||||||0.0022
71904727|NCT02665364|143330916|SUPERIORITY|||||||0.7946|||||||Wilcoxon (Mann-Whitney)|||Baseline to last available value between W24 and W36||||0.7946
71904728|NCT02665364|143330917|SUPERIORITY|||||||0.9224|||||||student - pooled|||||||0.9224
71904729|NCT02665364|143330918|SUPERIORITY|||||||0.3258|||||||student - pooled|||||||0.3258
71904730|NCT02665364|143330919|SUPERIORITY|||||||0.6169|||||||Student - Satterthwaite|||||||0.6169
71904731|NCT02665364|143330920|SUPERIORITY||Odds Ratio (OR)|1.81||||0.0796|TWO_SIDED|95.0|0.932|3.524|||Regression, Logistic|||||3.524|0.932|0.0796
71904732|NCT02665364|143330921|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0762|TWO_SIDED|95.0|0.938|3.574|||Regression, Logistic|||||3.574|0.938|0.0762
71904733|NCT02665364|143330924|SUPERIORITY|||||||0.0097|||||||Student - Satterthwaite|||||||0.0097
71904734|NCT02665364|143330925|SUPERIORITY|||||||0.0425|||||||Pearson's Chi-squared|||||||0.0425
71904735|NCT02665364|143330926|SUPERIORITY|||||||0.0396|||||||Pearson's Chi-squared|||||||0.0396
71904736|NCT03888391|143330927|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|Time: F = 1.72, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.20
71904737|NCT03888391|143330929|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 44.47, df = 1/33||Outcomes fitted via a mixed model with time as a predictor.||||<.0001
71904738|NCT03888391|143330930|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|Time: F = 15.74, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.0004
71904739|NCT03888391|143330931|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|Time: F = .28, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.60
71904740|NCT03888391|143330932|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|Time: F = 1.04, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.32
71904741|NCT03888391|143330933|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|Time: F = 1.27, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.||||.27
71904742|NCT01954251|143330946|NON_INFERIORITY_OR_EQUIVALENCE|Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.|Adjusted Geometric mean concentration ra|1.08|||||TWO_SIDED|95.0|0.97|1.2||||||Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.||1.20|0.97|
71921899|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-20.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose AM||3.5|-20.2|
71921900|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-13.4|STANDARD_ERROR_OF_MEAN|7.1|||TWO_SIDED|95.0|-28.1|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||1.4|-28.1|
71854088|NCT02983877|143222452|SUPERIORITY||||||<|0.001|||||||Friedman test|3 degrees of freedom||||||<0.001
71921901|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-10.3|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-24.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 1 hour||3.3|-24.0|
71921902|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-10.1|STANDARD_ERROR_OF_MEAN|8.2|||TWO_SIDED|95.0|-27.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||6.9|-27.0|
71921903|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|7.6|||TWO_SIDED|95.0|-20.4|11.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 postdose AM 4 hour||11.1|-20.4|
71921904|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.2|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-19.5|11.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||11.0|-19.5|
71921905|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-15.4|12.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8 predose PM||12.8|-15.4|
71921906|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-12.7|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-23.0|-2.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||-2.5|-23.0|
71921907|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-5.2|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-14.7|4.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9 predose AM||4.3|-14.7|
71854089|NCT02983877|143222453|SUPERIORITY|||||||0.89|||||||ANOVA|2 degrees of freedom||||||0.89
71854090|NCT03721978|143222454|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|28.6||||0.115|TWO_SIDED|95.0|-24.6|50.4|||Miettinen and Nurminen method|||||50.4|-24.6|0.115
71854091|NCT03721978|143222459|SUPERIORITY|Superiority was concluded if the one-sided p-value was \<0.025 and the corresponding lower bound of the 95% CI exceeded zero (0).|Difference in Percentage|18.9||||0.001|TWO_SIDED|95.0|7.8|28.6|||Miettinen and Nurminen method|||||28.6|7.8|0.001
71854092|NCT03721978|143222460|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
71854093|NCT03721978|143222461|OTHER||Difference in Percentage|12.6|||||TWO_SIDED|95.0|-0.8|24.5||||||||24.5|-0.8|
71921908|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-19.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose AM||2.9|-19.0|
71921909|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.8|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-14.0|6.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10 predose||6.3|-14.0|
71921910|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-16.1|STANDARD_ERROR_OF_MEAN|7.2|||TWO_SIDED|95.0|-31.0|-1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||-1.2|-31.0|
71921911|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-22.1|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11 predose AM||5.6|-22.1|
71921912|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-14.6|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||7.9|-14.6|
71921913|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-15.9|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12 predose AM||4.9|-15.9|
71921914|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.9|STANDARD_ERROR_OF_MEAN|4.9|||TWO_SIDED|95.0|-22.1|-1.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||-1.7|-22.1|
71921915|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-16.0|2.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose AM||2.9|-16.0|
71680710|NCT00483704|142879868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.65|||<|0.001|TWO_SIDED|95.0|1.3|2.11|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.11|1.30|<0.001
71680711|NCT00483704|142879868|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.14|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.14|1.31|<0.001
71680712|NCT00483704|142879869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74|||<|0.001|TWO_SIDED|95.0|1.36|2.22|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.22|1.36|<0.001
71680713|NCT00483704|142879869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||<|0.001|TWO_SIDED|95.0|1.26|2.06|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.06|1.26|<0.001
71680714|NCT00483704|142879870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67|||<|0.001|TWO_SIDED|95.0|1.28|2.17|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.17|1.28|<0.001
71680715|NCT00483704|142879870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57|||<|0.001|TWO_SIDED|95.0|1.21|2.04|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.04|1.21|<0.001
71680716|NCT00483704|142879873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69|||<|0.001|TWO_SIDED|95.0|1.78|4.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.07|1.78|<0.001
71680717|NCT00483704|142879873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.3|5.19|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.19|2.30|<0.001
71680718|NCT00483704|142879874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.001|TWO_SIDED|95.0|1.56|3.69|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.69|1.56|<0.001
71680719|NCT00483704|142879874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.37|||<|0.001|TWO_SIDED|95.0|2.22|5.12|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.12|2.22|<0.001
71680720|NCT00483704|142879875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.001|TWO_SIDED|95.0|1.65|3.38|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.38|1.65|<0.001
71854094|NCT03721978|143222462|OTHER||Difference in Percentage|38.1|||||TWO_SIDED|95.0|-15.7|59.5||||||||59.5|-15.7|
71854095|NCT03721978|143222463|OTHER||Difference in Percentage|27.9|||||TWO_SIDED|95.0|16.0|38.2||||||||38.2|16.0|
71854096|NCT03721978|143222464|OTHER||Difference in Percentage|13.1|||||TWO_SIDED|95.0|-37.7|46.0||||||||46.0|-37.7|
71854097|NCT03721978|143222465|OTHER||Difference in Percentage|17.6|||||TWO_SIDED|95.0|5.2|28.5||||||||28.5|5.2|
71854098|NCT03721978|143222466|OTHER||Difference in Percentage|28.6|||||TWO_SIDED|95.0|-24.6|50.4||||||||50.4|-24.6|
71854099|NCT03721978|143222467|OTHER||Difference in Percentage|20.3|||||TWO_SIDED|95.0|10.1|29.5||||||||29.5|10.1|
71854100|NCT03721978|143222468|OTHER||Difference in Percentage|1.2|||||TWO_SIDED|95.0|-31.2|50.5||||||||50.5|-31.2|
71854101|NCT03721978|143222469|OTHER||Difference in Percentage|5.3|||||TWO_SIDED|95.0|-6.0|17.9||||||||17.9|-6.0|
71854102|NCT03721978|143222470|OTHER||Difference in Percentage|-6.0|||||TWO_SIDED|95.0|-54.7|25.8||||||||25.8|-54.7|
71854103|NCT03721978|143222471|OTHER||Difference in Percentage|12.2|||||TWO_SIDED|95.0|1.1|21.9||||||||21.9|1.1|
71854104|NCT03721978|143222472|OTHER||Location Shift|449.0|||||TWO_SIDED|95.0|0.0|18224.0||||||Week 15: HPV-16 E7||18224.0|0.0|
71854105|NCT03721978|143222472|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|-18224.0|674.0||||||Week 36: HPV-16 E7||674.0|-18224.0|
71854106|NCT03721978|143222472|OTHER||Location Shift|4049.0|||||TWO_SIDED|95.0|224.0|18224.0||||||Week 15: HPV-18 E7||18224.0|224.0|
71854107|NCT03721978|143222472|OTHER||Location Shift|74.0|||||TWO_SIDED|95.0|-18000.0|6074.0||||||Week 36: HPV-18 E7||6074.0|-18000.0|
71854108|NCT03721978|143222473|OTHER||Location Shift|224.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 15: HPV-16 E7||674.0|224.0|
71854109|NCT03721978|143222473|OTHER||Location Shift|0.0|||||TWO_SIDED|95.0|0.0|24.0||||||Week 36: HPV-16 E7||24.0|0.0|
71854110|NCT03721978|143222473|OTHER||Location Shift|2024.0|||||TWO_SIDED|95.0|2024.0|6074.0||||||Week 15: HPV-18 E7||6074.0|2024.0|
71854111|NCT03721978|143222473|OTHER||Location Shift|674.0|||||TWO_SIDED|95.0|224.0|674.0||||||Week 36: HPV-18 E7||674.0|224.0|
71854112|NCT03721978|143222474|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|0.0|73.33||||||HPV-16 E6: Week 15||73.33|0.00|
71854113|NCT03721978|143222474|OTHER||Location Shift|15.0|||||TWO_SIDED|95.0|0.0|38.33||||||HPV-16 E6: Week 36||38.33|0.00|
71854114|NCT03721978|143222474|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|0.0|85.0||||||HPV-16 E7: Week 15||85.00|0.00|
71854115|NCT03721978|143222474|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|0.0|36.67||||||HPV-16 E7: Week 36||36.67|0.00|
71854116|NCT03721978|143222474|OTHER||Location Shift|26.67|||||TWO_SIDED|95.0|0.0|181.67||||||HPV-18 E6: Week 15||181.67|0.00|
71854117|NCT03721978|143222474|OTHER||Location Shift|11.67|||||TWO_SIDED|95.0|0.0|31.67||||||HPV-18 E6: Week 36||31.67|0.00|
71854118|NCT03721978|143222474|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|0.0|46.67||||||HPV-18 E7: Week 15||46.67|0.00|
71854119|NCT03721978|143222474|OTHER||Location Shift|4.17|||||TWO_SIDED|95.0|0.0|20.0||||||HPV-18 E7: Week 36||20.00|0.00|
71854120|NCT03721978|143222475|OTHER||Location Shift|8.33|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 15||11.67|3.33|
71854121|NCT03721978|143222475|OTHER||Location Shift|5.83|||||TWO_SIDED|95.0|3.33|11.67||||||HPV-16 E6: Week 36||11.67|3.33|
71854122|NCT03721978|143222475|OTHER||Location Shift|5.0|||||TWO_SIDED|95.0|1.67|11.67||||||HPV-16 E7: Week 15||11.67|1.67|
71854123|NCT03721978|143222475|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|5.0||||||HPV-16 E7: Week 36||5.00|0.00|
71854124|NCT03721978|143222475|OTHER||Location Shift|25.0|||||TWO_SIDED|95.0|15.0|40.0||||||HPV-18 E6: Week 15||40.00|15.00|
71854125|NCT03721978|143222475|OTHER||Location Shift|16.67|||||TWO_SIDED|95.0|10.0|28.33||||||HPV-18 E6: Week 36||28.33|10.00|
71854126|NCT03721978|143222475|OTHER||Location Shift|3.33|||||TWO_SIDED|95.0|1.67|6.67||||||HPV-18 E7: Week 15||6.67|1.67|
71854127|NCT03721978|143222475|OTHER||Location Shift|1.67|||||TWO_SIDED|95.0|0.0|3.33||||||HPV-18 E7: Week 36||3.33|0.00|
71854128|NCT03721978|143222476|OTHER||Location Shift|0.033|||||TWO_SIDED|95.0|-0.004|0.325||||||Parameter: CD8+CD137+Perforin+||0.325|-0.004|
71854129|NCT03721978|143222476|OTHER||Location Shift|0.005|||||TWO_SIDED|95.0|0.0|0.208||||||Parameter: CD8+CD38+Perforin+||0.208|0.000|
71854130|NCT03721978|143222476|OTHER||Location Shift|0.014|||||TWO_SIDED|95.0|-0.055|0.31||||||Parameter: CD8+CD69+Perforin+||0.310|-0.055|
71854131|NCT03721978|143222477|OTHER||Location Shift|0.041|||||TWO_SIDED|95.0|0.004|0.077||||||Parameter: CD8+CD137+Perforin+||0.077|0.004|
71854132|NCT03721978|143222477|OTHER||Location Shift|0.011|||||TWO_SIDED|95.0|0.003|0.028||||||Parameter: CD8+CD38+Perforin+||0.028|0.003|
71854133|NCT03721978|143222477|OTHER||Location Shift|0.034|||||TWO_SIDED|95.0|0.022|0.053||||||Parameter: CD8+CD69+Perforin+||0.053|0.022|
71854134|NCT05244226|143222478|SUPERIORITY|||||||0.045|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.045
71854135|NCT05244226|143222478|SUPERIORITY|||||||0.023|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.023
71854136|NCT05244226|143222482|SUPERIORITY|||||||0.144|||||||Kruskal-Wallis|||||||0.144
71854137|NCT05244226|143222482|SUPERIORITY|||||||0.322|||||||Kruskal-Wallis|||||||0.322
71854138|NCT05244226|143222483|SUPERIORITY|||||||0.061|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.061
71854139|NCT05244226|143222483|SUPERIORITY|||||||0.021|||||||Kruskal-Wallis|Dunn's Kruskal Wallis with Bonferroni correction||||||0.021
71854140|NCT00733226|143222484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_ERROR_OF_MEAN|0.52||0.05|TWO_SIDED|95.0|-3.2|-1.1||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The sample size was computed to prove that a 30% decrease of the rate of virus provoked wheezing attacks in the OM-85 group compared with placebo is statistically significant. Approximately 29 analyzable participants in each group were required, with α=0.05 and β=0.10 (ie, with a power of 90%), respectively. The difference of 30% was taken from both pilot study and clinical experience. Sample size estimation was performed by using NCSS and PASS 2000 software.||-1.10|-3.20|0.05
71854141|NCT00733226|143222485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-3.06|-1.01||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||-1.01|-3.06|<0.001
71854142|NCT00733226|143222486|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.94|-1.27|||Wilcoxon (Mann-Whitney)|P value was not need to adjusted for multiple comparisons||||-1.27|-2.94|<0.001
71854143|NCT00733226|143222487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.22||0.11|TWO_SIDED|95.0|-0.77|0.11||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.11|-0.77|0.110
71854144|NCT00733226|143222488|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14||0.195|TWO_SIDED|95.0|-0.55|0.03||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.03|-0.55|0.195
71854145|NCT00733226|143222489|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|0.82||0.452|TWO_SIDED|95.0|-2.87|0.42||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||||0.42|-2.87|0.452
71854146|NCT03722485|143222491|SUPERIORITY|||||||0.292||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Regression, Linear|Test of treatment effect using a generalized linear model with treatment arm, baseline values, and clinical site as factors.||||||0.2920
71854147|NCT03722485|143222492|SUPERIORITY|||||||0.0213||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.0213
71854148|NCT03722485|143222493|SUPERIORITY|||||||0.7422||||||Confounding variables of image capture techniques, image quality and image analysis noted throughout study conduct prohibits any definitive conclusions to be drawn from this analysis.|Wilcoxon (Mann-Whitney)|||||||0.7422
71854149|NCT03722485|143222494|SUPERIORITY|||||||0.6322|||||||Fisher Exact|||||||0.6322
71680721|NCT00483704|142879875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.81|||<|0.001|TWO_SIDED|95.0|1.97|4.01|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.01|1.97|<0.001
71680722|NCT00483704|142879876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32|||<|0.001|TWO_SIDED|95.0|1.52|3.54|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.54|1.52|<0.001
71680723|NCT00483704|142879876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02|||<|0.001|TWO_SIDED|95.0|2.0|4.56|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.56|2.00|<0.001
71680724|NCT04442269|142879877|SUPERIORITY||Mean Difference|0.201||||0.0022|TWO_SIDED|95.0|0.0768|0.3256|||Mixed Models Analysis|||||0.3256|0.0768|0.0022
71680725|NCT00819780|142879891|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.871||||0.3531|TWO_SIDED|95.0|0.651|1.166|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.166|0.651|0.3531
71680726|NCT00819780|142879892|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.723||||0.1386|TWO_SIDED|95.0|0.47|1.111|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.111|0.470|0.1386
71822065|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-8.5|-5.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.2|-8.5|<0.001
71822066|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-7.3|-3.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.3|-7.3|<0.001
71822067|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|1.03|<|0.001|TWO_SIDED|95.0|-8.8|-4.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.7|-8.8|<0.001
71921916|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-14.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-25.4|-3.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-3.2|-25.4|
71921917|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.8|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-22.1|-1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 1 hour||-1.5|-22.1|
71854150|NCT02762500|143222501|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
71854151|NCT02762500|143222502|SUPERIORITY||Risk Difference (RD)|-8.1||||0.106|TWO_SIDED|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||2.5|-18.6|0.106
71854152|NCT02762500|143222503|SUPERIORITY||Risk Difference (RD)|-6.5||||0.235|TWO_SIDED|90.0|-21.1|8.2||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||8.2|-21.1|0.235
71854153|NCT02762500|143222504|SUPERIORITY||Risk Difference (RD)|-9.7||||0.14|TWO_SIDED|90.0|-24.3|5.0||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.||5.0|-24.3|0.140
71854154|NCT02762500|143222505|SUPERIORITY||Mean Difference (Final Values)|-44.59||||0.032|TWO_SIDED|90.0|-78.66|-10.53|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.||-10.53|-78.66|0.032
71854155|NCT02762500|143222506|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.708|TWO_SIDED|90.0|-0.6|0.95|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||||0.95|-0.60|0.708
71854156|NCT02229396|143222508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.129||0.003|TWO_SIDED|95.0|-0.63|-0.13|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.13|-0.63|0.003
71854157|NCT02229396|143222508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.84|-0.34|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.34|-0.84|<0.001
71854158|NCT02229396|143222509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.406|<|0.001|TWO_SIDED|95.0|-2.79|-1.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-1.20|-2.79|<0.001
71854159|NCT02229396|143222509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.12|-0.55|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.55|-2.12|<0.001
71854160|NCT02229396|143222510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.08|STANDARD_ERROR_OF_MEAN|4.007|<|0.001|TWO_SIDED|95.0|-27.95|-12.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-12.20|-27.95|<0.001
71854161|NCT02229396|143222510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.64|STANDARD_ERROR_OF_MEAN|3.947|<|0.001|TWO_SIDED|95.0|-24.39|-8.89|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.89|-24.39|<0.001
71854162|NCT02229396|143222511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.74|STANDARD_ERROR_OF_MEAN|5.168|<|0.001|TWO_SIDED|95.0|-37.89|-17.59|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-17.59|-37.89|<0.001
71854163|NCT02229396|143222511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.78|STANDARD_ERROR_OF_MEAN|5.09|<|0.001|TWO_SIDED|95.0|-36.78|-16.78|||ANCOVA|Treatment, region, and baseline HbA1c stratum (\<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.||||-16.78|-36.78|<0.001
71854164|NCT02229396|143222512|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
71904743|NCT01954251|143330947|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.04|||||TWO_SIDED|95.0|0.88|1.22||||||For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.22|0.88|
71921918|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.7|STANDARD_ERROR_OF_MEAN|8.4|||TWO_SIDED|95.0|-29.0|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||5.6|-29.0|
71921919|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-9.8|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-25.9|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose AM 4 hour||6.2|-25.9|
71854165|NCT02229396|143222512|SUPERIORITY_OR_OTHER||Difference in percentages|13.3||||0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||0.001
71854166|NCT02229396|143222513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.26|STANDARD_ERROR_OF_MEAN|3.494|<|0.001|TWO_SIDED|95.0|-27.12|-13.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-13.40|-27.12|<0.001
71854167|NCT02229396|143222513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.03|STANDARD_ERROR_OF_MEAN|3.477|<|0.001|TWO_SIDED|95.0|-21.85|-8.2||This is a nominal p-value.|Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-8.20|-21.85|<0.001
71854168|NCT02229396|143222514|SUPERIORITY_OR_OTHER||Difference in percentages|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
71854169|NCT02229396|143222514|SUPERIORITY_OR_OTHER||Difference in percentages|25.6|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (\<9.0% or ≥9.0%).||||||<0.001
71854170|NCT02229396|143222515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.08||0.005|TWO_SIDED|95.0|-5.2|-0.9|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.9|-5.2|0.005
71854171|NCT02229396|143222515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|1.06||0.022|TWO_SIDED|95.0|-4.5|-0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (\<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.||||-0.4|-4.5|0.022
71854172|NCT00377312|143222520|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71854173|NCT00377312|143222521|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71854174|NCT00377312|143222522|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71854175|NCT00377312|143222523|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.01
71854176|NCT00377312|143222524|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05|TWO_SIDED|||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.05
71854177|NCT00377312|143222525|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002|TWO_SIDED|||||the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.002
71854178|NCT00377312|143222527|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61|TWO_SIDED|||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||.61
71854179|NCT00377312|143222528|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008|TWO_SIDED|||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.008
71854180|NCT00377312|143222528|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71921920|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-11.3|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|95.0|-22.4|-0.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 postdose PM||-0.1|-22.4|
71921921|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-9.9|STANDARD_ERROR_OF_MEAN|5.0|||TWO_SIDED|95.0|-20.2|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13 predose PM||0.4|-20.2|
71822068|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-9.9|-6.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.6|-9.9|<0.001
71822069|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.2|-4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.1|-8.2|<0.001
71822070|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.04|<|0.001|TWO_SIDED|95.0|-8.5|-4.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-8.5|<0.001
71822071|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|0.74|<|0.001|TWO_SIDED|95.0|-8.0|-5.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-8.0|<0.001
71822072|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-6.5|-3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-6.5|<0.001
71822073|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-5.6|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-7.4|-3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.8|-7.4|<0.001
71822074|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-5.9|-3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.4|-5.9|<0.001
71822075|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.6|-1.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-4.6|<0.001
71822076|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.79|<|0.001|TWO_SIDED|95.0|-4.9|-1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.9|-4.9|<0.001
71822077|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-2.6|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.8|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-3.8|<0.001
71822078|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.74||0.23|TWO_SIDED|95.0|-2.4|0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.6|-2.4|0.23
71854181|NCT00377312|143222529|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71680727|NCT00819780|142879893|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.5497|TWO_SIDED|95.0|0.72|1.95|||Stratified exact test|Stratified by prior adjuvant oxaliplatin therapy|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||1.95|0.72|0.5497
71680728|NCT00819780|142879895|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.874||||0.3861|TWO_SIDED|95.0|0.645|1.185|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.185|0.645|0.3861
71680729|NCT00819780|142879898|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.651||||0.0286|TWO_SIDED|95.0|0.444|0.956|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.956|0.444|0.0286
71680730|NCT00819780|142879899|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.579||||0.0083|TWO_SIDED|95.0|0.386|0.869|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.869|0.386|0.0083
71904744|NCT01954251|143330947|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.03|||||TWO_SIDED|95.0|0.91|1.17||||||For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.17|0.91|
71921922|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-5.8|STANDARD_ERROR_OF_MEAN|7.8|||TWO_SIDED|95.0|-22.0|10.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||10.5|-22.0|
71680731|NCT00819780|142879900|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.606||||0.0934|TWO_SIDED|95.0|0.337|1.088|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||1.088|0.337|0.0934
71680732|NCT00819780|142879901|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.465||||0.0235|TWO_SIDED|95.0|0.239|0.902|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio \< 1.0 favors panitumumab|||0.902|0.239|0.0235
71680733|NCT00819780|142879902|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.9426|TWO_SIDED|95.0|0.55|2.12|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.12|0.55|0.9426
71680734|NCT00819780|142879903|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.52|2.15|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.|||2.15|0.52|1.0000
71822079|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.75||0.005|TWO_SIDED|95.0|-3.6|-0.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-3.6|0.005
71822080|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-5.0|-2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.6|-5.0|<0.001
71822081|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.73||0.021|TWO_SIDED|95.0|-3.1|-0.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.3|-3.1|0.021
71822082|NCT02886728|143146004|SUPERIORITY||Least Squares Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|95.0|-4.3|-1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.4|-4.3|<0.001
71822083|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|7.6||||0.006|TWO_SIDED|95.0|2.2|12.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||12.9|2.2|0.006
71822084|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|4.9||||0.16|TWO_SIDED|95.0|-1.8|11.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||11.6|-1.8|0.16
71822085|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|7.6||||0.029|TWO_SIDED|95.0|1.1|14.1||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0.5||14.1|1.1|0.029
71680735|NCT04972968|142879917|SUPERIORITY||Cox Proportional Hazard|0.49||||0.012|TWO_SIDED|95.0|0.273|0.878||P-value \<= 0.05|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\].||||0.878|0.273|0.012
71680736|NCT04972968|142879917|SUPERIORITY||Cox Proportional Hazard|0.443||||0.004|TWO_SIDED|95.0|0.248|0.794||P-value \<= 0.01|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.794|0.248|0.004
71680737|NCT04972968|142879917|SUPERIORITY||Cox Proportional Hazard|0.198|||<|0.001|TWO_SIDED|95.0|0.094|0.419||P-value \<= 0.001|Log Rank|Stratified by baseline randomization stratification factors \[Glucocorticoid use at Baseline (\>= 10 mg/day; \< 10 mg/day prednisone equivalent)\]||||0.419|0.094|<0.001
71854182|NCT00377312|143222529|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>0.05
71854183|NCT00377312|143222530|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001|TWO_SIDED|||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||<.0001
71854184|NCT00377312|143222530|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01|TWO_SIDED|||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups||||||.01
71904745|NCT01954251|143330947|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2||||||For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.20|0.95|
71904746|NCT01954251|143330947|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09||||||For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.||1.09|0.88|
71854185|NCT00377312|143222531|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05|TWO_SIDED|||||the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)||||||>.05
71904747|NCT01722487|143330964|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.28|||Log Rank|||||0.28|0.09|<0.0001
71904748|NCT01722487|143330965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.16||||0.001|TWO_SIDED|95.0|0.05|0.56|||Log Rank|||||0.56|0.05|0.0010
71904749|NCT01722487|143330966|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71904750|NCT01722487|143330967|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71680738|NCT04972968|142879918|SUPERIORITY||Mean Difference (Net)|18.7||||0.107|TWO_SIDED|95.0|-4.0|41.4|||Cochran-Mantel-Haenszel||From Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid (GC) use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.4|-4.0|0.107
71680739|NCT04972968|142879918|SUPERIORITY||Mean Difference (Net)|18.9||||0.092|TWO_SIDED|95.0|-3.1|41.0||P-value ≤ 0.1|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||41.0|-3.1|0.092
71680740|NCT04972968|142879918|SUPERIORITY||Mean Difference (Net)|41.9|||<|0.001|TWO_SIDED|95.0|21.4|62.3||P-value ≤ 0.001|Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel test adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent); Length of prior GC treatment for PMR (≤ 1 year; \> 1 year)\].|||62.3|21.4|< 0.001
71680741|NCT04972968|142879919|SUPERIORITY||Mean Difference (Net)|-88.67||||0.144|TWO_SIDED|95.0|-208.04|30.71|||ANCOVA|P-value based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors.|95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[GC use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent);|||30.71|-208.04|0.144
71680742|NCT04972968|142879919|SUPERIORITY||Mean Difference (Net)|-164.76||||0.007|TWO_SIDED|95.0|-283.62|-45.89||P-value ≤ 0.01|ANCOVA||P-value and 95% CI are based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone\] equivalent);|||-45.89|-283.62|0.007
71680743|NCT04972968|142879919|SUPERIORITY||Mean Difference (Final Values)|-182.55||||0.003|TWO_SIDED|95.0|-300.52|-64.58||P-value ≤ 0.01|ANCOVA||P-value and 95% CI based on an Analysis of covariance (ANCOVA) model adjusting for baseline randomization stratification factors \[Glucocorticoid use at baseline (≥ 10 mg/day; \< 10 mg/day prednisone equivalent)|||-64.58|-300.52|0.003
71822086|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|8.1||||0.015|TWO_SIDED|95.0|1.6|14.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||14.6|1.6|0.015
71822087|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|4.2||||0.33|TWO_SIDED|95.0|-3.9|12.2||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||12.2|-3.9|0.33
71822088|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|10.2||||0.013|TWO_SIDED|95.0|2.5|17.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= 0||17.9|2.5|0.013
71822089|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|3.6||||0.074|TWO_SIDED|95.0|-0.3|7.6||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||7.6|-0.3|0.074
71822090|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|1.9||||0.49|TWO_SIDED|95.0|-3.1|6.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||6.9|-3.1|0.49
71822091|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|4.4||||0.075|TWO_SIDED|95.0|-0.2|8.9||P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24 for Change in mTSS \<= SDC (1.53)||8.9|-0.2|0.075
71822092|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|10.2|||<|0.001|TWO_SIDED|95.0|4.3|16.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||16.2|4.3|<0.001
71854186|NCT01066897|143222548|OTHER|||||||0.002|||||||Chi-squared|||||||.002
71854187|NCT01066897|143222549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.368|STANDARD_DEVIATION|0.44||0.067|TWO_SIDED||||||t-test, 2 sided|One sample t-test to determine if the % change in HAMD was different from 0||For the 2 dropouts, used LOCF.||||.067
71854188|NCT03861429|143222553|SUPERIORITY||Odds Ratio (OR)|3.32||||0.105|TWO_SIDED|95.0|0.78|14.15|||Mixed Models Analysis|||Multilevel logistic regression (generalized estimating equations \[GEE\] with an autoregressive (1) working correlation matrix, logit link function) were fitted to assess the primary hypotheses. The models account for the repeated measures (3 or 4 time points), correlated, data structure per person. An additive model was conducted with contrast coding for each time point, treatment, and follow-up effects.||14.15|.78|.105
71854189|NCT03861429|143222554|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.04|TWO_SIDED|95.0|0.022|1.178|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||1.178|.022|.04
71854190|NCT03861429|143222555|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.001|TWO_SIDED|95.0|0.12|0.46|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.46|.12|.001
71680744|NCT04972968|142879920|SUPERIORITY||Mean Difference (Net)|-1.58||||0.039|TWO_SIDED|95.0|-3.08|-0.08||P-value \<= 0.05|ANCOVA|P-value based on ANCOVA adjusting for baseline randomization stratification factors (GC use at baseline)||||-0.08|-3.08|0.039
71854191|NCT03861429|143222556|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.001|TWO_SIDED|95.0|0.21|0.48|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.48|.21|.001
71904751|NCT01722487|143330968|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71680745|NCT04972968|142879920|SUPERIORITY||Mean Difference (Final Values)|-2.66|||<|0.001|TWO_SIDED|95.0|-4.15|-1.16||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.16|-4.15|<0.001
71854192|NCT03861429|143222557|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.081|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||||.19|-.01|.081
71904752|NCT01722487|143330969|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Chi-squared|||||||.0009
71854193|NCT03861429|143222558|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.033|TWO_SIDED|95.0|0.11|0.3|||Mixed Models Analysis||Calculation of mean differences were derived from mixed model analyses|||.3|.11|.033
71904753|NCT01722487|143330970|SUPERIORITY_OR_OTHER|||||||0.0054|||||||Chi-squared|||||||.0054
71904754|NCT02175771|143330975|SUPERIORITY||geometric mean ratio|1.32|||||TWO_SIDED|90.0|1.02|1.72|||||Fp MDPI / FLOVENT HFA|Mid-strength comparison||1.72|1.02|
71904755|NCT02175771|143330975|SUPERIORITY||geometric mean ratio|0.81|||||TWO_SIDED|90.0|0.63|1.04|||||Fp MDPI / FLOVENT HFA|High-strength comparison||1.04|0.63|
71904756|NCT02175771|143330975|SUPERIORITY||geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.75|1.24|||||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||1.24|0.75|
71904757|NCT02175771|143330975|SUPERIORITY||geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.67|1.06|||||FS MDPI / ADVAIR DISKUS|High-strength comparison||1.06|0.67|
71854194|NCT05372913|143222562|NON_INFERIORITY|The non-inferiority (NI) test for the secondary outcome (i.e., PHQ-8 Week 4 EOT score) was assessed using the pre-specified NI margin of 2.0. NI of W-GenZD to CBT-Lite was declared if the upper bound of the one-sided 97.5% confidence interval (CI) was less than 2.|Mean Difference (Net)|-0.67|||||TWO_SIDED|95.0|-2.3|0.96||||||||0.96|-2.30|
71854195|NCT05135156|143222565|SUPERIORITY||Mean Difference (Final Values)|14.0||||0.02|TWO_SIDED|95.0|3.0|25.0|||Regression, Linear||Difference = intervention - control|||25|3|0.02
71854196|NCT05135156|143222566|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.15|TWO_SIDED|95.0|-1.0|6.6|||Regression, Linear||Difference = intervention - control|||6.6|-1.0|0.15
71854197|NCT05135156|143222567|SUPERIORITY||Mean Difference (Net)|-1.2||||0.81|TWO_SIDED|95.0|-10.9|8.5|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||8.5|-10.9|0.81
71854198|NCT05135156|143222568|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.15|TWO_SIDED|95.0|-0.1|0.8|||Regression, Linear||Difference = intervention - control|||0.8|-0.1|0.15
71854199|NCT05135156|143222569|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.54|TWO_SIDED|95.0|-2.0|3.7|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.7|-2.0|0.54
71854200|NCT05135156|143222571|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.82|TWO_SIDED|95.0|-2.1|2.7|||Regression, Linear||Difference = intervention - control|||2.7|-2.1|0.82
71854201|NCT05135156|143222573|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.44|TWO_SIDED|95.0|-15.0|7.0|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||7|-15|0.44
71854202|NCT05135156|143222574|SUPERIORITY||Mean Difference (Net)|1.3||||0.31|TWO_SIDED|95.0|-1.3|3.9|||Regression, Linear||Estimation parameter is regression parameter comparing intervention to control|||3.9|-1.3|0.31
71854203|NCT05135156|143222575|SUPERIORITY||Mean Difference (Net)|5.0||||0.42|TWO_SIDED|95.0|-7.4|17.4|||Regression, Linear||Difference = intervention - control||Estimation parameter is regression parameter comparing intervention to control|17.4|-7.4|0.42
71854204|NCT05135156|143222576|OTHER|Pearson's chi-squared test of independence||||||0.39||||||p=0.39 at baseline, 0.39 at 2 weeks and 0.23 at 4 weeks|Chi-squared|||||||0.39
71854205|NCT05135156|143222577|SUPERIORITY||Mean Difference (Net)|0.05||||0.91|TWO_SIDED|95.0|-0.84|0.94|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey) from baseline to 2-week study visit||0.94|-0.84|0.91
71854206|NCT05135156|143222577|SUPERIORITY||Mean Difference (Net)|0.04||||0.53|TWO_SIDED|95.0|-0.08|0.16|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Likert preparedness to discuss transplant from baseline to 2-week study visit||0.16|-0.08|0.53
71854207|NCT05135156|143222577|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.4|-0.3|||Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|Outcome = change in Decisional Conflict Scale from baseline to 2-week study visit||-0.3|-8.4|0.04
71854208|NCT05135156|143222577|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.74|TWO_SIDED|95.0|-3.6|5.0||Outcome = mean PrepDM Scale at 2-weeks|Regression, Linear||Parameters are for a 60-minute greater amount of time spent on the website (range was 21-418 minutes in the first 2 weeks).|||5.0|-3.6|0.74
71854209|NCT02402465|143222614|SUPERIORITY||Mean Difference (Final Values)|37.0|||>|0.05|TWO_SIDED||||||ANOVA||Mean difference is related to albumin levels in nasal lavages: Unit= ng/ml|||||>0.05
71854210|NCT02402465|143222615|SUPERIORITY||Friedman's Q|14.2||||0.001|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately yielding alpha=0.05/3.|Friedman|Non-parametric repeated measures ANOVA||||||0.001
71854211|NCT02402465|143222615|SUPERIORITY||Median Difference (Net)|24.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
71904758|NCT02175771|143330976|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.009|STANDARD_ERROR_OF_MEAN|0.0476||0.8451|TWO_SIDED|95.0|-0.084|0.103|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|Mid-strength comparison||0.103|-0.084|0.8451
71904759|NCT02175771|143330976|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|-0.013|STANDARD_ERROR_OF_MEAN|0.0479||0.7877|TWO_SIDED|95.0|-0.107|0.081|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|High-strength comparison||0.081|-0.107|0.7877
71904760|NCT02175771|143330976|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.0485||0.9966|TWO_SIDED|95.0|-0.095|0.095|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|Mid-strength comparison||0.095|-0.095|0.9966
71904761|NCT02175771|143330976|NON_INFERIORITY|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than -125 mL.|LSM difference|0.059|STANDARD_ERROR_OF_MEAN|0.0464||0.2056|TWO_SIDED|95.0|-0.032|0.15|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|High-strength comparison||0.150|-0.032|0.2056
71904762|NCT02232087|143330987|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
71680746|NCT04972968|142879920|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.49|-1.52||P-value \<= 0.001|ANCOVA|P-value based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|95% CI based on an ANCOVA model adjusting for baseline randomization stratification factors (GC use at baseline)|||-1.52|-4.49|<0.001
71680747|NCT00514904|142879953|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] greater than or equal to (≥) -10%.|Difference in percentage|14.77|||||TWO_SIDED|95.0|10.26|20.23||||||||20.23|10.26|
71822093|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|7.9||||0.045|TWO_SIDED|95.0|0.7|15.2||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||15.2|0.7|0.045
71904763|NCT02232087|143330988|EQUIVALENCE|The potency of the test and reference product was considered equivalent if the 90% CI for the estimate of relative potency was completely contained within the limits of 0.67 to 1.50|Odds Ratio, log|1.0|||>|0.1|TWO_SIDED|90.0|0.67|1.5||test for parallelism of dose response lines|ANOVA||Test is the numerator|The measurement of relative potency was conducted for the pair of doses which met the above criteria and lay on the steepest linear portion of the dose response curve. The log estimate of relative potency was obtained as the ratio of the estimated treatment effect as measured by the difference in the intercepts of the parallel lines divided by the estimate of the common slope for log dose.||1.50|0.67|>0.10
71904764|NCT02232087|143330989|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.55|TWO_SIDED|95.0|-2.5|1.4||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.4|-2.5|0.55
71904765|NCT02232087|143330989|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.53|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.53
71680748|NCT00514904|142879953|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|24.47|||||TWO_SIDED|95.0|17.52|31.87||||||||31.87|17.52|
71680749|NCT00514904|142879953|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|6.35|||||TWO_SIDED|95.0|2.68|11.08|||Difference in percentage|||||11.08|2.68|
71680750|NCT00514904|142879953|NON_INFERIORITY|Non-inferiority criterion: Lower limit \[LL\] of the 2-sided standardized asymptotic 95% confidence interval \[CI\] ≥-10%.|Difference in percentage|23.92|||||TWO_SIDED|95.0|18.02|30.3||||||||30.3|18.02|
71822094|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|6.5||||0.1|TWO_SIDED|95.0|-1.1|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0.5||14.0|-1.1|0.100
71822095|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|10.0||||0.004|TWO_SIDED|95.0|3.2|16.7||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||16.7|3.2|0.004
71822096|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|5.5||||0.25|TWO_SIDED|95.0|-2.9|14.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||14.0|-2.9|0.25
71822097|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|6.5||||0.14|TWO_SIDED|95.0|-2.0|15.0||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= 0||15.0|-2.0|0.14
71822098|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|7.5||||0.002|TWO_SIDED|95.0|2.8|12.3||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||12.3|2.8|0.002
71822099|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|8.2||||0.008|TWO_SIDED|95.0|2.9|13.6||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||13.6|2.9|0.008
71822100|NCT02886728|143146005|SUPERIORITY||Difference in Response Rates|2.5||||0.47|TWO_SIDED|95.0|-3.9|8.9||P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.|Regression, Logistic|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52 for Change in mTSS \<= SDC (1.77)||8.9|-3.9|0.47
71822101|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|95.0|2.4|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|2.4|<0.001
71822102|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|0.7|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.7|0.001
71822103|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.3|3.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|1.3|<0.001
71822104|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.7|4.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.8|2.7|<0.001
71822105|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.66||0.008|TWO_SIDED|95.0|0.5|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|0.5|0.008
71822106|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.66||0.023|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.023
71822107|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.59||0.003|TWO_SIDED|95.0|0.6|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.6|0.003
71854212|NCT02402465|143222615|SUPERIORITY||Median Difference (Net)|4.5||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
71854213|NCT02402465|143222615|SUPERIORITY||Median Difference (Net)|48.5||||0.53|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.53
71854214|NCT02402465|143222616|SUPERIORITY||Friedman's Q|5.22||||0.07|TWO_SIDED|||||Alpha=0.05/3 since 3 days are compared|Friedman's Test|||We used Friedman test to compare the distribution of total nasal symptom scores among three treatment groups (Placebo, Fluticasone propionate, Dymista) in each of the three days (day 1, day 2, and day 3).||||0.07
71680751|NCT00514904|142879954|NON_INFERIORITY|Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.|Risk Ratio (RR)|3.34||||0.2202|TWO_SIDED|95.0|0.56|20.25|||Chi-squared|||||20.25|0.56|0.2202
71680752|NCT00084318|142879972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.05|TWO_SIDED|95.0|0.54|1.06|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. \[RTOG = Radiation Therapy Oncology Group\]||1.06|0.54|0.05
71680753|NCT00084318|142879972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.01|TWO_SIDED|95.0|0.5|0.96|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.||0.96|0.50|0.01
71822108|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.71||0.38|TWO_SIDED|95.0|-0.8|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.8|0.38
71822109|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.59|TWO_SIDED|95.0|-1.0|1.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.8|-1.0|0.59
71822110|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|1.6|4.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.0|1.6|<0.001
71822111|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.76||0.11|TWO_SIDED|95.0|-0.3|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.3|0.11
71904766|NCT02232087|143330989|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|1.0||||0.011|TWO_SIDED|95.0|-2.5|1.3||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||1.3|-2.5|0.011
71904767|NCT02232087|143330990|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.26|TWO_SIDED|95.0|-0.03|0.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.10|-0.03|0.26
71904768|NCT02232087|143330990|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0|-0.06|0.06||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.06|-0.06|0.93
71904769|NCT02232087|143330990|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.48|TWO_SIDED|95.0|-0.04|0.08||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.08|-0.04|0.48
71680754|NCT00084318|142879973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.04|TWO_SIDED|95.0|0.5|1.03|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.03|0.5|0.04
71822112|NCT02886728|143146007|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.76||0.071|TWO_SIDED|95.0|-0.17|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.17|0.071
71904770|NCT02232087|143330991|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.93|TWO_SIDED|95.0||||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||||0.93
71822113|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|95.0|1.6|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.6|<0.001
71822114|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.7||0.032|TWO_SIDED|95.0|0.1|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|0.1|0.032
71822115|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.0|3.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.8|1.0|<0.001
71854215|NCT02402465|143222617|SUPERIORITY||Friedman's Q|5.06||||0.08|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.08
71854216|NCT02402465|143222619|SUPERIORITY||Friedman's Q|6.53||||0.04|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.04
71854217|NCT02402465|143222620|SUPERIORITY||Friedman's Q|0.53|||>|0.05|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||>0.05
71854218|NCT02402465|143222621|SUPERIORITY||Friedman's Q|0.33||||0.85|TWO_SIDED|||||Bonferroni correction was used to adjust for the fact that each day was tested separately, giving alpha=0.05/3.|Friedman's Test|||||||0.85
71854219|NCT03807700|143222622|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.58||0.4769|TWO_SIDED|95.0|-1.56|0.74|||ANCOVA|Analysis was performed using ANCOVA model with study product as a fixed effect and Baseline overall score as a covariate.|Difference is experimental adhesive minus no adhesive.|||0.74|-1.56|0.4769
71854220|NCT02005029|143222631|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
71854221|NCT02005029|143222632|SUPERIORITY_OR_OTHER||Erythromycin:Placebo AUC ratio|1.07|STANDARD_DEVIATION|0.43|||TWO_SIDED|||||||||||||
71854222|NCT02005029|143222633|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71854223|NCT02005029|143222634|SUPERIORITY_OR_OTHER|||||||0.18|||||||t-test, 2 sided|||||||0.18
71854224|NCT02005029|143222635|SUPERIORITY_OR_OTHER|||||||0.4405|||||||t-test, 2 sided|||||||0.4405
71854225|NCT02005029|143222636|SUPERIORITY_OR_OTHER|||||||0.6011|||||||t-test, 2 sided|||||||0.6011
71854226|NCT02005029|143222637|SUPERIORITY_OR_OTHER|||||||0.8923|||||||t-test, 2 sided|||||||0.8923
71854227|NCT02005029|143222638|SUPERIORITY_OR_OTHER|||||||0.832|||||||t-test, 2 sided|||||||0.832
71854228|NCT02005029|143222639|SUPERIORITY_OR_OTHER|||||||0.1546|||||||t-test, 2 sided|||||||0.1546
71854229|NCT02005029|143222640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|STANDARD_DEVIATION|5.0||0.0314|TWO_SIDED||||||t-test, 2 sided||"Mean difference in on score versus off score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on score versus off score on day of placebo."|||||0.0314
71854230|NCT02005029|143222641|SUPERIORITY_OR_OTHER||Erythromycin:Placebo Cmax ratio|0.83|STANDARD_DEVIATION|0.24|||TWO_SIDED|||||||||||||
71854231|NCT02137239|143222674|SUPERIORITY||Incidence of Change|-1.7|||||TWO_SIDED|95.0|-18.9|16.7||||||Change in Incidence of Treatment A as compared to Treatment B at 6 Months||16.7|-18.9|
71854232|NCT02137239|143222674|SUPERIORITY||Incidence of Change|-1.0|||||TWO_SIDED|95.0|-19.2|18.9||||||Change in Incidence of Treatment A as compared to Treatment B at 12 Months||18.9|-19.2|
71854233|NCT02137239|143222674|SUPERIORITY||Incidence of Change|2.9|||||TWO_SIDED|95.0|-16.1|23.9||||||Change in Incidence of Treatment A as compared to Treatment B at 24 Months||23.9|-16.1|
71854234|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||5.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000559
71854235|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||7.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2812338||||0.00000766
71854236|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs10824875||||0.00000982
71854237|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||1.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000127
71854238|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||3.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs10851257||||0.00000396
71854239|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||6.48e-06|TWO_SIDED||||||t-test, 2 sided|||rs6492344||||0.00000648
71854240|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs12584550||||0.00000221
71854241|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||9.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs9555773||||0.00000902
71854242|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000077
71854243|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000048
71904771|NCT02232087|143330991|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.42|TWO_SIDED|95.0|-0.224|0.093||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.093|-0.224|0.42
71822116|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.6||0.023|TWO_SIDED|95.0|0.2|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|0.2|0.023
71822117|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.74||0.065|TWO_SIDED|95.0|-0.1|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|-0.1|0.065
71822118|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.74||0.15|TWO_SIDED|95.0|-0.4|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.4|0.15
71854244|NCT01855997|143222701|SUPERIORITY_OR_OTHER|||||||3.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000037
71854245|NCT01855997|143222702|SUPERIORITY_OR_OTHER|||||||9.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs1876154||||0.00000987
71854246|NCT01855997|143222702|SUPERIORITY_OR_OTHER|||||||6.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs7753766||||0.00000605
71854247|NCT01855997|143222702|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs604241||||0.00000946
71854248|NCT01855997|143222702|SUPERIORITY_OR_OTHER|||||||7.7e-07|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000077
71854249|NCT01855997|143222702|SUPERIORITY_OR_OTHER|||||||1.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000197
71904772|NCT02232087|143330991|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.078|TWO_SIDED|95.0|-0.302|0.016||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||0.016|-0.302|0.078
71822119|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.73|TWO_SIDED|95.0|-1.0|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.0|0.73
71854250|NCT01855997|143222703|SUPERIORITY_OR_OTHER|||||||6.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000677
71854251|NCT01855997|143222703|SUPERIORITY_OR_OTHER|||||||7.98e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000798
71854252|NCT01855997|143222703|SUPERIORITY_OR_OTHER|||||||5.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000512
71854253|NCT01855997|143222703|SUPERIORITY_OR_OTHER|||||||3.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000345
71854254|NCT01855997|143222703|SUPERIORITY_OR_OTHER|||||||3.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs247878||||0.00000372
71854255|NCT01855997|143222704|SUPERIORITY_OR_OTHER|||||||4.59e-06|TWO_SIDED||||||t-test, 2 sided|||rs12210761||||0.00000459
71854256|NCT01855997|143222704|SUPERIORITY_OR_OTHER|||||||9.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs1411283||||0.00000925
71854257|NCT01855997|143222704|SUPERIORITY_OR_OTHER|||||||7.72e-06|TWO_SIDED||||||t-test, 2 sided|||rs12446868||||0.00000772
71854258|NCT01855997|143222705|SUPERIORITY_OR_OTHER|||||||4.7e-06|TWO_SIDED||||||t-test, 2 sided|||rs11163805||||0.00000470
71854259|NCT01855997|143222705|SUPERIORITY_OR_OTHER|||||||6.74e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000674
71854260|NCT01855997|143222705|SUPERIORITY_OR_OTHER|||||||9.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000952
71854261|NCT01855997|143222705|SUPERIORITY_OR_OTHER|||||||6.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs1831559||||0.00000608
71854262|NCT01855997|143222705|SUPERIORITY_OR_OTHER|||||||4.04e-06|TWO_SIDED||||||t-test, 2 sided|||rs7983441||||0.00000404
71854263|NCT01855997|143222705|SUPERIORITY_OR_OTHER|||||||4.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000407
71854264|NCT01855997|143222706|SUPERIORITY_OR_OTHER|||||||6.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000666
71854265|NCT01855997|143222706|SUPERIORITY_OR_OTHER|||||||8.44e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000844
71854266|NCT01855997|143222706|SUPERIORITY_OR_OTHER|||||||7.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000794
71854267|NCT01855997|143222706|SUPERIORITY_OR_OTHER|||||||3.1e-06|TWO_SIDED||||||t-test, 2 sided|||rs11868362||||0.00000310
71854268|NCT01855997|143222707|SUPERIORITY_OR_OTHER|||||||2.07e-06|TWO_SIDED||||||t-test, 2 sided|||rs11139349||||0.00000207
71854269|NCT01855997|143222707|SUPERIORITY_OR_OTHER|||||||8.99e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000899
71854270|NCT01855997|143222708|SUPERIORITY_OR_OTHER|||||||5.73e-06|TWO_SIDED||||||t-test, 2 sided|||rs1384010||||0.00000573
71854271|NCT01855997|143222708|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs1351518||||0.00000946
71854272|NCT01855997|143222708|SUPERIORITY_OR_OTHER|||||||7.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs1157322||||0.00000731
71854273|NCT01855997|143222708|SUPERIORITY_OR_OTHER|||||||9.45e-06|TWO_SIDED||||||t-test, 2 sided|||rs646097||||0.00000945
71854274|NCT01855997|143222709|SUPERIORITY_OR_OTHER|||||||1.6e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000016
71854275|NCT01855997|143222710|SUPERIORITY_OR_OTHER|||||||8.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000088
71854276|NCT01855997|143222711|SUPERIORITY_OR_OTHER|||||||8.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs2464266||||0.00000879
71854277|NCT01855997|143222712|SUPERIORITY_OR_OTHER|||||||4.52e-06|TWO_SIDED||||||t-test, 2 sided|||rs9496139||||0.00000452
71854278|NCT01855997|143222712|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2014238||||0.00000497
71854279|NCT01855997|143222712|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2980231||||0.00000497
71854280|NCT01855997|143222713|SUPERIORITY_OR_OTHER|||||||7.48e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000748
71854281|NCT01855997|143222713|SUPERIORITY_OR_OTHER|||||||7.3e-07|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000073
71854282|NCT01855997|143222713|SUPERIORITY_OR_OTHER|||||||2.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs2899723||||0.00000289
71854283|NCT01855997|143222713|SUPERIORITY_OR_OTHER|||||||9.12e-06|TWO_SIDED||||||t-test, 2 sided|||rs8027115||||0.00000912
71854284|NCT01855997|143222713|SUPERIORITY_OR_OTHER|||||||4.94e-06|TWO_SIDED||||||t-test, 2 sided|||exm2267780||||0.00000494
71854285|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||6.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs9973954||||0.00000627
71854286|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||6.96e-06|TWO_SIDED||||||t-test, 2 sided|||exm2237722||||0.00000696
71854287|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||4.26e-06|TWO_SIDED||||||t-test, 2 sided|||rs1040084||||0.00000426
71854288|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||4.35e-06|TWO_SIDED||||||t-test, 2 sided|||rs1913484||||0.00000435
71854289|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||2.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16924016||||0.00000221
71854290|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||5.23e-06|TWO_SIDED||||||t-test, 2 sided|||exm1010813||||0.00000523
71854291|NCT01855997|143222714|SUPERIORITY_OR_OTHER|||||||7.57e-06|TWO_SIDED||||||t-test, 2 sided|||rs6576456||||0.00000757
71854292|NCT01855997|143222715|SUPERIORITY_OR_OTHER|||||||1.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000153
71854293|NCT01855997|143222715|SUPERIORITY_OR_OTHER|||||||7.08e-06|TWO_SIDED||||||t-test, 2 sided|||rs10475403||||0.00000708
71854294|NCT01855997|143222715|SUPERIORITY_OR_OTHER|||||||7.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000727
71854295|NCT01855997|143222716|SUPERIORITY_OR_OTHER|||||||3.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000397
71854296|NCT01855997|143222717|SUPERIORITY_OR_OTHER|||||||6.86e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000686
71854297|NCT01855997|143222717|SUPERIORITY_OR_OTHER|||||||5.96e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000596
71854298|NCT01855997|143222717|SUPERIORITY_OR_OTHER|||||||4.89e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000489
71854299|NCT01855997|143222718|SUPERIORITY_OR_OTHER|||||||8.34e-06|TWO_SIDED||||||t-test, 2 sided|||rs2189452||||0.00000834
71854300|NCT01855997|143222718|SUPERIORITY_OR_OTHER|||||||4.87e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000487
71854301|NCT01855997|143222718|SUPERIORITY_OR_OTHER|||||||9.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000918
71854302|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||1.37e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000137
71854303|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||3.39e-06|TWO_SIDED||||||t-test, 2 sided|||rs2803073||||0.00000339
71854304|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||9.27e-06|TWO_SIDED||||||t-test, 2 sided|||rs1937590||||0.00000927
71854305|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||1.66e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000166
71854306|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||4.55e-06|TWO_SIDED||||||t-test, 2 sided|||rs1997894||||0.00000455
71854307|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||5.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs1495471||||0.00000568
71854308|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||1.25e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000125
71854309|NCT01855997|143222719|SUPERIORITY_OR_OTHER|||||||9.82e-06|TWO_SIDED||||||t-test, 2 sided|||rs1152537||||0.00000982
71854310|NCT01855997|143222720|SUPERIORITY_OR_OTHER|||||||8.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs10236906||||0.00000846
71854311|NCT01855997|143222720|SUPERIORITY_OR_OTHER|||||||5.62e-06|TWO_SIDED||||||t-test, 2 sided|||rs2945861||||0.00000562
71854312|NCT01855997|143222720|SUPERIORITY_OR_OTHER|||||||4.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs7042473||||0.00000497
71854313|NCT01855997|143222720|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs2077415||||0.00000997
71854314|NCT01855997|143222720|SUPERIORITY_OR_OTHER|||||||8.64e-06|TWO_SIDED||||||t-test, 2 sided|||rs9324018||||0.00000864
71854315|NCT01855997|143222721|SUPERIORITY_OR_OTHER|||||||3.68e-06|TWO_SIDED||||||t-test, 2 sided|||rs17037122||||0.00000368
71854316|NCT01855997|143222721|SUPERIORITY_OR_OTHER|||||||5.77e-06|TWO_SIDED||||||t-test, 2 sided|||rs715243||||0.00000577
71854317|NCT01855997|143222722|SUPERIORITY_OR_OTHER|||||||9.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs2302503||||0.00000950
71854318|NCT01855997|143222722|SUPERIORITY_OR_OTHER|||||||7.41e-06|TWO_SIDED||||||t-test, 2 sided|||rs6015181||||0.00000741
71854319|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||8.05e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550116||||0.00000805
71854320|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs1550115||||0.00000702
71854321|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||7.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2082881||||0.00000702
71854322|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||7.43e-06|TWO_SIDED||||||t-test, 2 sided|||exm2265462||||0.00000743
71854323|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||7.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000078
71854324|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||8.94e-06|TWO_SIDED||||||t-test, 2 sided|||rs1403069||||0.00000894
71854325|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||5.71e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000571
71854326|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||7.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs8012912||||0.00000729
71854327|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||8.28e-06|TWO_SIDED||||||t-test, 2 sided|||rs11158827||||0.00000828
71854328|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||8.85e-06|TWO_SIDED||||||t-test, 2 sided|||rs11870323||||0.00000885
71854329|NCT01855997|143222723|SUPERIORITY_OR_OTHER|||||||7.17e-06|TWO_SIDED||||||t-test, 2 sided|||rs4821558||||0.00000717
71854330|NCT01855997|143222724|SUPERIORITY_OR_OTHER|||||||6.29e-06|TWO_SIDED||||||t-test, 2 sided|||rs6443144||||0.00000629
71854331|NCT01855997|143222724|SUPERIORITY_OR_OTHER|||||||5.79e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692421||||0.00000579
71854332|NCT01855997|143222724|SUPERIORITY_OR_OTHER|||||||5.53e-06|TWO_SIDED||||||t-test, 2 sided|||rs1692423||||0.00000553
71854333|NCT01855997|143222724|SUPERIORITY_OR_OTHER|||||||9.46e-06|TWO_SIDED||||||t-test, 2 sided|||rs9691873||||0.00000946
71854334|NCT01855997|143222724|SUPERIORITY_OR_OTHER|||||||4.5e-06|TWO_SIDED||||||t-test, 2 sided|||rs7968170||||0.00000450
71854335|NCT01855997|143222725|SUPERIORITY_OR_OTHER|||||||1.18e-06|TWO_SIDED||||||t-test, 2 sided|||rs9287655||||0.00000118
71854336|NCT01855997|143222725|SUPERIORITY_OR_OTHER|||||||5.31e-06|TWO_SIDED||||||t-test, 2 sided|||rs216312||||0.00000531
71854337|NCT01855997|143222726|SUPERIORITY_OR_OTHER|||||||5.93e-06|TWO_SIDED||||||t-test, 2 sided|||rs993147||||0.00000593
71854338|NCT01855997|143222726|SUPERIORITY_OR_OTHER|||||||9.97e-06|TWO_SIDED||||||t-test, 2 sided|||rs10978436||||0.00000997
71854339|NCT01855997|143222726|SUPERIORITY_OR_OTHER|||||||5.81e-06|TWO_SIDED||||||t-test, 2 sided|||rs2370220||||0.00000581
71854340|NCT01855997|143222726|SUPERIORITY_OR_OTHER|||||||8.02e-06|TWO_SIDED||||||t-test, 2 sided|||rs2279519||||0.00000802
71854341|NCT01855997|143222727|SUPERIORITY_OR_OTHER|||||||5.58e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000558
71854342|NCT01855997|143222728|SUPERIORITY_OR_OTHER|||||||9.9e-06|TWO_SIDED||||||t-test, 2 sided|||rs12992677||||0.00000990
71854343|NCT01855997|143222729|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
71854344|NCT01855997|143222730|SUPERIORITY_OR_OTHER|||||||4.8e-07|TWO_SIDED||||||t-test, 2 sided|||rs7549785||||0.00000048
71854345|NCT01855997|143222731|SUPERIORITY_OR_OTHER|||||||7.38e-06|TWO_SIDED||||||t-test, 2 sided|||rs10814834||||0.00000738
71854346|NCT01855997|143222731|SUPERIORITY_OR_OTHER|||||||4.51e-06|TWO_SIDED||||||t-test, 2 sided|||rs10491723||||0.00000451
71854347|NCT01855997|143222731|SUPERIORITY_OR_OTHER|||||||8.78e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000878
71680755|NCT00084318|142879973|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.001|TWO_SIDED|95.0|0.39|0.82|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.||0.82|0.39|0.001
71680756|NCT00084318|142879977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.66|TWO_SIDED|95.0|0.63|1.76|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. \[RTOG = Radiation Therapy Oncology Group\]||1.76|0.63|0.66
71680757|NCT00084318|142879977|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.86|TWO_SIDED|95.0|0.72|1.87|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.||1.87|0.72|0.86
71680758|NCT00715104|142880039|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|16.2||||1|TWO_SIDED|95.0|1.7|30.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||30.7|1.7|1.000
71680759|NCT00715104|142880039|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|18.9||||1|TWO_SIDED|95.0|3.5|34.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||34.3|3.5|1.000
71854348|NCT01855997|143222731|SUPERIORITY_OR_OTHER|||||||5.21e-06|TWO_SIDED||||||t-test, 2 sided|||rs16943470||||0.00000521
71854349|NCT01855997|143222732|SUPERIORITY_OR_OTHER|||||||7.2e-06|TWO_SIDED||||||t-test, 2 sided|||rs6592052||||0.00000720
71854350|NCT04474691|143222751|SUPERIORITY||Mean Difference (Final Values)|21.1||||0.67|TWO_SIDED||||||t-test, 1 sided|df = 7|Traditional treatment condition - visual-acoustic biofeedback treatment condition. Because more accurate productions have lower acoustic values, a positive difference would indicate an advantage for biofeedback.|||||.67
71904773|NCT02232087|143330992|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||0.71|TWO_SIDED|95.0|-3.9|5.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||5.7|-3.9|0.71
71904774|NCT02232087|143330992|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-4.7|4.7||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||4.7|-4.7|1.00
71688693|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|0.75||0.0106|TWO_SIDED|90.0|0.78|3.33|||t-test, 2 sided|||FEV1/FVC Day 1 (1 hrs post-dose)||3.33|0.78|0.0106
71854351|NCT02391116|143222781|OTHER||Percentage Difference|2.2|||||TWO_SIDED|90.0|-28.7|32.9|||Exact confidence intervals (CI)||ORR difference in FAS (N=54): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||32.9|-28.7|
71854352|NCT02391116|143222781|OTHER||Percentage Difference|0.0|||||TWO_SIDED|90.0|-33.5|33.5|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup|||33.5|-33.5|
71854353|NCT02391116|143222782|OTHER||Percentage Difference|16.4|||||TWO_SIDED|90.0|-7.2|39.1|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||39.1|-7.2|
71854354|NCT02391116|143222782|OTHER||Percentage Difference|20.8|||||TWO_SIDED|90.0|-6.8|46.2|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)|||46.2|-6.8|
71854355|NCT02391116|143222782|OTHER||Percentage Difference|-18.5|||||TWO_SIDED|90.0|-40.1|4.6|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||4.6|-40.1|
71854356|NCT02391116|143222782|OTHER||Percentage Difference|-25.3|||||TWO_SIDED|90.0|-49.1|1.1|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)|||1.1|-49.1|
71854357|NCT02391116|143222782|OTHER||Percentage Difference|12.9|||||TWO_SIDED|90.0|-42.4|63.2|||Exact confidence intervals (CI)||ORR difference in FAS (N=52): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||63.2|-42.4|
71680760|NCT00715104|142880039|SUPERIORITY_OR_OTHER||% Subjects with 2-fold increase|70.3|||<|0.001|TWO_SIDED|95.0|52.3|88.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||88.3|52.3|<0.001
71680761|NCT00715104|142880040|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|20.6||||1|TWO_SIDED|95.0|4.0|37.2||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||37.2|4.0|1.000
71680762|NCT00715104|142880040|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|32.4||||0.014|TWO_SIDED|95.0|13.1|51.6||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||51.6|13.1|0.014
71680763|NCT00715104|142880040|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|79.4|||<|0.001|TWO_SIDED|95.0|62.8|96.0||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||96.0|62.8|<0.001
71680764|NCT00715104|142880041|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|35.1||||0.002|TWO_SIDED|95.0|16.3|53.9||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||53.9|16.3|0.002
71904775|NCT02232087|143330992|EQUIVALENCE|Comparability confirmed if confidence interval includes zero.|Mean Difference (Final Values)|-2.0||||0.016|TWO_SIDED|95.0|-10.6|-1.1||Comparability demonstrated for p\>0.05|ANOVA||Comparability confirmed if confidence interval includes zero.|For each dose, the 95% CIs for the mean differences for the test product versus the reference product were calculated.||-1.1|-10.6|0.016
71904776|NCT04069156|143330993|NON_INFERIORITY|The primary end point assessing non-inferiority of placebo was considered met if the lower boundary of the one-sided 97.5% confidence limit of the difference in the composite success rate between treatment arms (placebo minus aspirin) was greater than the non-inferiority margin (-10%) by the Farrington-Manning test at 12-months in the principal analysis population.|Risk Difference (RD)|6.0|||<|0.0001|ONE_SIDED|97.5|-1.6||||Farrington-Manning risk difference||||||-1.6|<0.0001
71688694|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.32|STANDARD_ERROR_OF_MEAN|0.66||0.0013|TWO_SIDED|90.0|1.2|3.44|||t-test, 2 sided|||FEV1/FVC Day 1 (2 hrs post-dose)||3.44|1.20|0.0013
71854358|NCT02391116|143222782|OTHER||Percentage Difference|26.3|||||TWO_SIDED|90.0|-44.3|77.6|||Exact confidence intervals (CI)||ORR difference in PPS (N=40): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)|||77.6|-44.3|
71854359|NCT01261793|143222809|SUPERIORITY||Odds Ratio (OR)|1.024|||=|0.899|TWO_SIDED|95.0|0.71|1.477||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.477|0.710|=0.899
71854360|NCT01261793|143222809|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.716|TWO_SIDED|95.0|0.743|1.539||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|||1.539|0.743|=0.716
71854361|NCT00832650|143222820|SUPERIORITY_OR_OTHER||LS Mean difference|0.051|||||TWO_SIDED|95.0|-0.334|0.436|||ANCOVA||Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.|Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.||0.436|-0.334|
71854362|NCT00714688|143222850|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-2.7|STANDARD_ERROR_OF_MEAN|1.51||0.136||95.0|-6.04|0.67||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||0.67|-6.04|0.136
71854363|NCT00714688|143222850|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.9|STANDARD_ERROR_OF_MEAN|1.5||0.002||95.0|-8.22|-1.55||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||-1.55|-8.22|0.002
71854364|NCT00714688|143222851|SUPERIORITY_OR_OTHER|||||||0.216||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model was performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.216
71854365|NCT00714688|143222851|SUPERIORITY_OR_OTHER||||||<|0.001||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender \& country were used as factors and baseline value \& age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||<0.001
71854366|NCT00714688|143222852|SUPERIORITY_OR_OTHER|||||||0.052||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.052
71854367|NCT00714688|143222852|SUPERIORITY_OR_OTHER|||||||0.002||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.||||||0.002
71904777|NCT04096326|143331026|SUPERIORITY||Rate difference|40.6||||0.0096|TWO_SIDED|95.0|23.6|57.6||P-value was based on Cochran-Mantel-Haenszel (CMH) tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||57.6|23.6|0.0096
71904778|NCT04096326|143331026|SUPERIORITY||Rate difference|46.4||||0.0094|TWO_SIDED|95.0|28.0|64.9||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||64.9|28.0|0.0094
71904779|NCT04096326|143331026|SUPERIORITY||Rate difference|52.2||||0.0044|TWO_SIDED|95.0|23.6|80.8||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||80.8|23.6|0.0044
71904780|NCT04096326|143331026|SUPERIORITY||Rate difference|63.3||||0.0026|TWO_SIDED|95.0|35.2|91.5||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||91.5|35.2|0.0026
71854368|NCT00714688|143222853|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.2|STANDARD_ERROR_OF_MEAN|1.86||0.023||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.023
71854369|NCT00714688|143222853|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|-4.4|STANDARD_ERROR_OF_MEAN|1.83||0.016||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.||||0.016
71854370|NCT04341584|143222879|SUPERIORITY||Median posterior HR|0.97|||||TWO_SIDED|90.0|0.62|1.52|||Bayesian Cox model|adjusted for age and centre|% Confidence Interval is % Credible Interval here|||1.52|0.62|
71854371|NCT04341584|143222880|SUPERIORITY||Median posterior absolute risk differenc|-2.5|||||TWO_SIDED|90.0|-17.1|12.0|||Bayesian analysis||% Confidence Interval is % Credible Interval here|||12|-17.1|
71854372|NCT04341584|143222881|SUPERIORITY||Median posterior HR|1.26|||||TWO_SIDED|90.0|0.59|2.81||adjusted for age and centre|Bayesian Fine and Gray analysis||% Confidence interval is % Credible Interval here|||2.81|0.59|
71854373|NCT04341584|143222882|SUPERIORITY||Median posterior absolute risk differenc|24.0|||||TWO_SIDED|90.0|3.9|43.5|||Bayesian analysis||% Confidence interval is % Credible interval here|||43.5|3.9|
71854374|NCT04341584|143222883|SUPERIORITY||Median posterior OR|0.8|||||TWO_SIDED|95.0|0.38|1.68|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 4||1.68|0.38|
71854375|NCT04341584|143222883|SUPERIORITY||Median posterior OR|0.69|||||TWO_SIDED|95.0|0.33|1.43|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 14||1.43|0.33|
71904781|NCT04096326|143331026|SUPERIORITY||Rate difference|85.7||||0|TWO_SIDED|95.0|64.2|100.0||P-value was based on CMH tests stratified by baseline GL severity at maximum frown to compare each AGN-151586 study intervention group versus placebo for each cohort.|Cochran-Mantel-Haenszel|||||100.0|64.2|0.0000
71680765|NCT00715104|142880041|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|29.7||||0.036|TWO_SIDED|95.0|11.7|47.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||47.7|11.7|0.036
71680766|NCT00715104|142880041|SUPERIORITY_OR_OTHER||% subjects with 2-fold increase|83.8|||<|0.001|TWO_SIDED|95.0|69.3|98.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p\*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.||98.3|69.3|<0.001
71822120|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.37|TWO_SIDED|95.0|-0.8|2.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.2|-0.8|0.37
71822121|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.78||0.83|TWO_SIDED|95.0|-1.7|1.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.4|-1.7|0.83
71822122|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.66||0.073|TWO_SIDED|95.0|-0.1|2.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.5|-0.1|0.073
71822123|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|1.4|STANDARD_ERROR_OF_MEAN|0.8||0.09|TWO_SIDED|95.0|-0.2|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.2|0.090
71822124|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.68|TWO_SIDED|95.0|-1.9|1.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.2|-1.9|0.68
71822125|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.67||0.3|TWO_SIDED|95.0|-0.6|2.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.0|-0.6|0.30
71822126|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.69|TWO_SIDED|95.0|-1.3|1.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.9|-1.3|0.69
71822127|NCT02886728|143146009|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.82||0.95|TWO_SIDED|95.0|-1.7|1.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.5|-1.7|0.95
71822128|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|2.1|4.4||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.4|2.1|<0.001
71822129|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
71680767|NCT00715104|142880042|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||<0.001
71854376|NCT04341584|143222883|SUPERIORITY||Median posterior OR|0.7|||||TWO_SIDED|95.0|0.35|1.38|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence interval is % Credible interval here|Day 28||1.38|0.35|
71854377|NCT04341584|143222883|SUPERIORITY||Median posterior OR|0.72|||||TWO_SIDED|95.0|0.22|2.39|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 4||2.39|0.22|
71854378|NCT04341584|143222883|SUPERIORITY||Median posterior HR|0.89|||||TWO_SIDED|95.0|0.28|2.8|||Bayesian Proportionnal odds model|Adjusted for age and centre|% Confidence Interval is % Credible interval here|Day 7||2.80|0.28|
71854379|NCT04341584|143222883|SUPERIORITY||Median posterior HR|0.57|||||TWO_SIDED|95.0|0.18|1.75||Day 14|Bayesian Proportionnal odds model|Adjusted for afe and centre|% Confidence Interval is % Credible interval here|||1.75|0.18|
71854380|NCT04341584|143222884|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.23|1.29|||Regression, Cox|adjusted for age and centre||14 days||1.29|0.23|
71854381|NCT04341584|143222884|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.33|1.77|||Regression, Cox|Adjusted for age and centre||28 days||1.77|0.33|
71854382|NCT04341584|143222884|SUPERIORITY|90 days|Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.46|2.04|||Regression, Cox|adjusted on age and centre|% Confidence interval is % Credible interval here|||2.04|0.46|
71854383|NCT04341584|143222884|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.11|3.86|||Regression, Cox|adjusted on age and centre||||3.86|0.11|
71854384|NCT04341584|143222884|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.19|4.68|||Regression, Cox|adjusted on age and centre||||4.68|0.19|
71904782|NCT00543569|143331043|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|13.6|||||TWO_SIDED|90.0|3.2|23.9|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||23.9|3.2|
71904783|NCT00543569|143331043|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||15.8|-3.6|
71854385|NCT04341584|143222884|SUPERIORITY||Cox Proportional Hazard|1.22|||||TWO_SIDED|95.0|0.31|4.87|||Regression, Cox|adjusted on age and centre||||4.87|0.31|
71854386|NCT04341584|143222885|SUPERIORITY||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-8.3|6.4||||adjusted on age and centre||||6.4|-8.3|
71854387|NCT04341584|143222887|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.64|1.61|||Fine-Gray model|Adjusted for age and centre||||1.61|0.64|
71854388|NCT04341584|143222887|SUPERIORITY||Hazard Ratio (HR)|1.33|||||TWO_SIDED|95.0|0.58|3.07||Adjusted for age and centre|Fine-Gray model|Adjusted for age and centre||||3.07|0.58|
71854389|NCT04341584|143222888|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.56|1.48|||Fine-Gray model|adjusted on age and centre||||1.48|0.56|
71854390|NCT04341584|143222888|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.35|2.34||adjusted on age and centre|Fine-Gray model|||||2.34|0.35|
71854391|NCT04341584|143222889|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.43|2.32||adjusted on age and centre|Fine-Gray model|||Day 28||2.32|0.43|
71854392|NCT04341584|143222889|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.52|2.29||adjusted on age and centre|Fine-Gray model|||Day 90||2.29|0.52|
71854393|NCT02799745|143222900|SUPERIORITY||Hazard Ratio (HR)|0.542||||0.016|TWO_SIDED|95.0|0.33|0.892||P-value was from a 2-sided stratified log-rank test.|Log Rank||HR, 95% CI for HR:based on a Cox regression model assuming proportional hazards with treatment, prostate cancer risk,type of biopsy,baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.892|0.330|0.016
71854394|NCT02799745|143222902|SUPERIORITY||Odds Ratio (OR)|3.5||||0|TWO_SIDED|95.0|1.76|6.92||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 12||6.92|1.76|0.00
71854395|NCT02799745|143222902|SUPERIORITY||Odds Ratio (OR)|1.6||||0.289|TWO_SIDED|95.0|0.66|4.0||P-value: Based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where fixed covariates=treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis; random effects: site and subject. 95% CI: based on exact binomial distribution.|At the end of month 24||4.00|0.66|0.289
71854396|NCT02799745|143222903|SUPERIORITY||LS mean difference|-10.07|STANDARD_ERROR_OF_MEAN|2.398|<|0.001|TWO_SIDED|95.0|-14.79|-5.34||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|Mixed model repeated measure(MMRM) with treatment group, prostate cancer risk(low/intermediate), type of biopsy(mpMRI-targeted/non-mpMRI-targeted), visit, visit-by-treatment, baseline scores as fixed factors, site and participants as random factors.|Change at month 12||-5.34|-14.79|<0.001
71854397|NCT02799745|143222903|SUPERIORITY||LS mean difference|-5.15|STANDARD_ERROR_OF_MEAN|3.174||0.1063|TWO_SIDED|95.0|-11.4|1.11||P-values: from differences of least squares means.Bonferroni-Holm was used in the primary hypothesis testing to adjust for multiplicity.|Mixed Models Analysis|Compound symmetry was used as the covariance structure. Covariance parameters:estimated using Restricted Maximum likelihood.|MMRM with treatment group, prostate cancer risk (low vs. intermediate), type of biopsy (mpMRI targeted vs. non mpMRI targeted), visit, visit-by-treatment and baseline scores were the fixed factors, and site and participants were the random factors.|Change at month 24||1.11|-11.40|0.1063
71822130|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.3|4.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|1.3|<0.001
71822131|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|2.2|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.0|3.5||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.5|1.0|<0.001
71822132|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.78||0.13|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.13
71822133|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.79||0.032|TWO_SIDED|95.0|0.1|3.2||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.2|0.1|0.032
71680768|NCT00715104|142880043|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED|||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.||||0.173
71822134|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.67||0.028|TWO_SIDED|95.0|0.2|2.8||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.8|0.2|0.028
71822135|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.81||0.15|TWO_SIDED|95.0|-0.4|2.7||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.7|-0.4|0.15
71822136|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.81||0.41|TWO_SIDED|95.0|-0.9|2.3||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.3|-0.9|0.41
71822137|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.71||0.017|TWO_SIDED|95.0|0.3|3.1||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.1|0.3|0.017
71822138|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.27|TWO_SIDED|95.0|-0.7|2.6||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.6|-0.7|0.27
71822139|NCT02886728|143146011|SUPERIORITY||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.87||0.15|TWO_SIDED|95.0|-0.5|2.9||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.9|-0.5|0.15
71822140|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|6.0|12.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|6.0|<0.001
71904784|NCT00543569|143331043|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3|||||A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).|||13.3|-5.3|
71904785|NCT00543569|143331044|SUPERIORITY_OR_OTHER||Difference|-1.4|||||TWO_SIDED|90.0|-6.9|4.1||||||Patient survival at 6 months||4.1|-6.9|
71680769|NCT00715104|142880044|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.667
71680770|NCT00715104|142880044|SUPERIORITY_OR_OTHER|||||||0.191|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.191
71680771|NCT00715104|142880044|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.699
71680772|NCT00715104|142880045|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.086
71680773|NCT00715104|142880045|SUPERIORITY_OR_OTHER|||||||0.432|TWO_SIDED|||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.432
71822141|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|95.0|1.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|1.0|0.006
71822142|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|3.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|3.0|<0.001
71822143|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|<0.001
71822144|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.8||0.089|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.089
71822145|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-1.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-1.0|0.18
71904786|NCT00543569|143331044|SUPERIORITY_OR_OTHER||Difference|1.1|||||TWO_SIDED|90.0|-3.5|5.8||||||Patient survival at 6 months||5.8|-3.5|
71680774|NCT00715104|142880045|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED|||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.||||0.249
71680775|NCT00715104|142880046|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.950
71680776|NCT00715104|142880047|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.||||0.048
71680777|NCT04599933|142880048|SUPERIORITY||Odds Ratio (OR)|2.916|||<|0.01|TWO_SIDED|95.0|1.663|5.113|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.113|1.663|<0.01
71680778|NCT04599933|142880049|SUPERIORITY||Odds Ratio (OR)|3.035|||<|0.01|TWO_SIDED|95.0|1.736|5.305|||Regression, Logistic|||||5.305|1.736|<0.01
71680779|NCT04599933|142880050|SUPERIORITY||Odds Ratio (OR)|4.751|||<|0.01|TWO_SIDED|95.0|2.694|8.379|||Regression, Logistic|||||8.379|2.694|<0.01
71680780|NCT04599933|142880051|SUPERIORITY||Odds Ratio (OR)|3.422|||<|0.01|TWO_SIDED|95.0|1.923|6.09|||Regression, Logistic|||||6.090|1.923|<0.01
71904787|NCT00543569|143331044|SUPERIORITY_OR_OTHER||Difference|-2.6|||||TWO_SIDED|90.0|-8.4|3.2||||||Patient survival at 6 months||3.2|-8.4|
71904788|NCT00543569|143331044|SUPERIORITY_OR_OTHER||Difference|4.9|||||TWO_SIDED|90.0|-3.1|12.8||||||Patient survival at 12 months||12.8|-3.1|
71904789|NCT00543569|143331044|SUPERIORITY_OR_OTHER||Difference|0.5|||||TWO_SIDED|90.0|-8.3|9.2||||||Patient survival at 12 months||9.2|-8.3|
71904790|NCT00543569|143331044|SUPERIORITY_OR_OTHER||Difference|2.4|||||TWO_SIDED|90.0|-6.0|10.8||||||Patient survival at 12 months||10.8|-6.0|
71904791|NCT00543569|143331045|SUPERIORITY_OR_OTHER||Difference|-2.7|||||TWO_SIDED|90.0|-8.5|3.1||||||Graft survival at 6 months||3.1|-8.5|
71904792|NCT00543569|143331045|SUPERIORITY_OR_OTHER||Difference|-0.2|||||TWO_SIDED|90.0|-5.3|4.9||||||Graft survival at 6 months||4.9|-5.3|
71904793|NCT00543569|143331045|SUPERIORITY_OR_OTHER||Difference|-3.9|||||TWO_SIDED|90.0|-10.0|2.2||||||Graft survival at 6 months||2.2|-10.0|
71680781|NCT03408444|142880086|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.063|STANDARD_ERROR_OF_MEAN|0.0181|||TWO_SIDED|95.0|-0.106|-0.02|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.020|-0.106|
71680782|NCT03408444|142880086|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0183|||TWO_SIDED|95.0|-0.1|-0.013|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.013|-0.100|
71822146|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.5||0.003|TWO_SIDED|95.0|1.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|1.0|0.003
71904794|NCT00543569|143331045|SUPERIORITY_OR_OTHER||Difference|3.6|||||TWO_SIDED|90.0|-4.6|11.7||||||Graft survival at 12 months||11.7|-4.6|
71904795|NCT00543569|143331045|SUPERIORITY_OR_OTHER||Difference|-0.9|||||TWO_SIDED|90.0|-9.9|8.1||||||Graft survival at 12 months||8.1|-9.9|
71904796|NCT00543569|143331045|SUPERIORITY_OR_OTHER||Difference|-1.6|||||TWO_SIDED|90.0|-10.6|7.4||||||Graft survival at 12 months||7.4|-10.6|
71904797|NCT00543569|143331046|SUPERIORITY_OR_OTHER||Difference|13.7|||||TWO_SIDED|90.0|2.8|24.6||||||||24.6|2.8|
71904798|NCT00543569|143331046|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.4|15.0||||||||15.0|-5.4|
71904799|NCT00543569|143331046|SUPERIORITY_OR_OTHER||Difference|2.8|||||TWO_SIDED|90.0|-7.1|12.6||||||||12.6|-7.1|
71904800|NCT00543569|143331047|SUPERIORITY_OR_OTHER||Difference|10.6|||||TWO_SIDED|90.0|1.8|19.5||||||BCAR at Month 6||19.5|1.8|
71680783|NCT03408444|142880086|SUPERIORITY|Superiority is established if the adjusted upper confidence limit is below 0.|Mean Difference|-0.105|STANDARD_ERROR_OF_MEAN|0.0184|||TWO_SIDED|95.0|-0.149|-0.062|||Mixed Models Analysis|The Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 90% power to detect a 0.08 mm difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||-0.062|-0.149|
71904801|NCT00543569|143331047|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 6||12.3|-3.6|
71904802|NCT00543569|143331047|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||BCAR at Month 6||14.6|-1.7|
71904803|NCT00543569|143331047|SUPERIORITY_OR_OTHER||Difference|12.0|||||TWO_SIDED|90.0|3.0|21.0||||||BCAR at Month 12||21.0|3.0|
71904804|NCT00543569|143331047|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||BCAR at Month 12||12.3|-3.6|
71904805|NCT00543569|143331047|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||BCAR at Month 12||16.2|-0.6|
71904806|NCT00543569|143331048|SUPERIORITY_OR_OTHER||Difference|12.2|||||TWO_SIDED|90.0|2.0|22.5||||||T-cell Mediated BCAR at Month 6||22.5|2.0|
71904807|NCT00543569|143331048|SUPERIORITY_OR_OTHER||Difference|6.1|||||TWO_SIDED|90.0|-3.6|15.8||||||T-cell Mediated BCAR at Month 6||15.8|-3.6|
71904808|NCT00543569|143331048|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-5.3|13.3||||||T-cell Mediated BCAR at Month 6||13.3|-5.3|
71904809|NCT00543569|143331048|SUPERIORITY_OR_OTHER||Difference|13.6|||||TWO_SIDED|90.0|3.0|24.3||||||T-cell Mediated BCAR at Month 12||24.3|3.0|
71904810|NCT00543569|143331048|SUPERIORITY_OR_OTHER||Difference|4.8|||||TWO_SIDED|90.0|-5.1|14.6||||||T-cell Mediated BCAR at Month 12||14.6|-5.1|
71904811|NCT00543569|143331048|SUPERIORITY_OR_OTHER||Difference|4.1|||||TWO_SIDED|90.0|-5.6|13.8||||||T-cell Mediated BCAR at Month 12||13.8|-5.6|
71904812|NCT00543569|143331049|SUPERIORITY_OR_OTHER||Difference|9.3|||||TWO_SIDED|90.0|0.7|18.0||||||T-cell Mediated BCAR at Month 6||18.0|0.7|
71904813|NCT00543569|143331049|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 6||12.3|-3.6|
71904814|NCT00543569|143331049|SUPERIORITY_OR_OTHER||Difference|6.4|||||TWO_SIDED|90.0|-1.7|14.6||||||T-cell Mediated BCAR at Month 6||14.6|-1.7|
71904815|NCT00543569|143331049|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|1.8|19.5||||||T-cell Mediated BCAR at Month 12||19.5|1.8|
71904816|NCT00543569|143331049|SUPERIORITY_OR_OTHER||Difference|4.3|||||TWO_SIDED|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 12||12.3|-3.6|
71904817|NCT00543569|143331049|SUPERIORITY_OR_OTHER||Difference|7.8|||||TWO_SIDED|90.0|-0.6|16.2||||||T-cell Mediated BCAR at Month 12||16.2|-0.6|
71904818|NCT00543569|143331053|SUPERIORITY_OR_OTHER||Difference|14.7|||||TWO_SIDED|90.0|3.8|25.5||||||Efficacy Failure at Month 6||25.5|3.8|
71904819|NCT00543569|143331053|SUPERIORITY_OR_OTHER||Difference|7.5|||||TWO_SIDED|90.0|-2.9|17.8||||||Efficacy Failure at Month 6||17.8|-2.9|
71904820|NCT00543569|143331053|SUPERIORITY_OR_OTHER||Difference|7.9|||||TWO_SIDED|90.0|-2.4|18.2||||||Efficacy Failure at Month 6||18.2|-2.4|
71904821|NCT00543569|143331053|SUPERIORITY_OR_OTHER||Difference|8.4|||||TWO_SIDED|90.0|-3.5|20.4||||||Efficacy Failure at Month12||20.4|-3.5|
71904822|NCT00543569|143331053|SUPERIORITY_OR_OTHER||Difference|4.0|||||TWO_SIDED|90.0|-7.8|15.8||||||Efficacy Failure at Month 12||15.8|-7.8|
71822147|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|4.0|STANDARD_ERROR_OF_MEAN|1.8||0.049|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|0.0|0.049
71822148|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.8||0.84|TWO_SIDED|95.0|-4.0|3.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-4.0|0.84
71822149|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.0|9.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||9.0|2.0|<0.001
71822150|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|2.0||0.078|TWO_SIDED|95.0|0.0|7.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.0|-0.0|0.078
71822151|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.0||0.39|TWO_SIDED|95.0|-2.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-2.0|0.39
71822152|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.7||0.004|TWO_SIDED|95.0|2.0|8.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||8.0|2.0|0.004
71822153|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.45|TWO_SIDED|95.0|-3.0|6.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.0|-3.0|0.45
71822154|NCT02886728|143146014|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-4.0|5.0||MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.0|-4.0|0.85
71822155|NCT02724020|143146029|SUPERIORITY||Hazard Ratio (HR)|1.33|||=|0.388|TWO_SIDED|95.0|0.75|2.36|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.36|0.75|=0.388
71822156|NCT02724020|143146029|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.667|TWO_SIDED|95.0|0.75|2.52|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.52|0.75|0.667
71822157|NCT02724020|143146031|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.212|TWO_SIDED|95.0|0.89|3.49|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||3.49|0.89|0.212
71680784|NCT03408444|142880087|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.053|||TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|Kenward and Roger method was for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.21|-0.04|
71822158|NCT02724020|143146031|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.546|TWO_SIDED|95.0|0.77|2.98|||Stratified Log-rank Test||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category. A hazard ratio \< 1 indicated an advantage compared to Everolimus.|||2.98|0.77|0.546
71822159|NCT02724020|143146032|SUPERIORITY||Hazard Ratio (HR)|1.57|||=|0.156|TWO_SIDED|95.0|0.81|3.05|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||3.05|0.81|=0.156
71822160|NCT02724020|143146032|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.667|TWO_SIDED|95.0|0.72|2.79|||Log Rank||HR obtained by stratified Cox proportion hazard model adjusted for prior lines of therapy and the International Metastatic Renal Cell Carcinoma Database Consortium risk category. A hazard ratio \< 1 indicates an advantage compared to Everolimus.|||2.79|0.72|0.667
71822161|NCT02724020|143146033|SUPERIORITY||Odds Ratio (OR)|0.41|||||TWO_SIDED|95.0|0.08|2.22|||||Odds ratio and 95% CI were obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|As prespecified in the protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only.|As prespecified in protocol, the statistical analysis was performed between arms - Arm A: Single-agent Everolimus 10 mg QD and Arm C: Combination of MLN0128 4 mg QD + MLN1117 200 mg QD only for this outcome measure.|2.22|0.08|
71822162|NCT02724020|143146034|SUPERIORITY||Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.24|1.69|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.69|0.24|
71822163|NCT02724020|143146034|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.28|2.21|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||2.21|0.28|
71822164|NCT02724020|143146035|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.16|1.38|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.38|0.16|
71822165|NCT02724020|143146035|SUPERIORITY||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.2|1.8|||||Odds ratio and 95% CI was obtained using a stratified CMH model with prior lines of therapy and the international metastatic renal cell carcinoma database consortium risk category.|||1.80|0.20|
71822166|NCT02118714|143146040|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|80.0|10.7|41.6||||||||41.6|10.7|
71822167|NCT02118714|143146040|OTHER||Percentage of Participants|23.5|||||TWO_SIDED|95.0|6.8|49.9||||||||49.9|6.8|
71854398|NCT02799745|143222904|SUPERIORITY||Hazard Ratio (HR)|0.714||||0.032|TWO_SIDED|95.0|0.525|0.972||P-value: from a 2-sided, stratified log-rank test.|Log Rank||HR and 95% CI for HR:based on Cox regression model assuming proportional hazards with treatment, prostate cancer risk, type of biopsy, baseline variables(as age, race), time since prostate cancer diagnosis as fixed effects and random effect of site.|||0.972|0.525|0.032
71854399|NCT02799745|143222905|SUPERIORITY||Odds Ratio (OR)|0.1||||0|TWO_SIDED|95.0|0.08|0.26||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR:from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 12||0.26|0.08|0.000
71904823|NCT00543569|143331053|SUPERIORITY_OR_OTHER||Difference|4.2|||||TWO_SIDED|90.0|-7.5|15.9||||||Efficacy Failure at Month12||15.9|-7.5|
71822168|NCT02118714|143146041|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|80.0|3.2|28.4||||||||28.4|3.2|
71822169|NCT02118714|143146041|OTHER||Percentage of Participants|11.8|||||TWO_SIDED|95.0|1.5|36.4||||||||36.4|1.5|
71822170|NCT04227340|143146084|OTHER|The count, percentage and confidence interval will be calculated for allogeneic HCT patients who receive PBM and develop Grade 3 mucositis|Odds Ratio (OR)|0.2|||||TWO_SIDED|95.0|0.091|0.356|||||Odds of grade 3 in Allogeneic group compared to historical rates. The study efficacy of mucositis reduction by 20% with an estimation of 51% developing grade 3 mucositis.|The count, percentage and confidence interval were calculated for allogeneic HCT participants who receive PBM and developed Grade 3 mucositis. Whether the percentage of the prospective sample is significantly different from the estimated rate of 71% was accessed.||0.356|0.091|
71822171|NCT04227340|143146085|SUPERIORITY|||||||0.03|||||||Wilcox Rank Sum|||||||0.03
71822172|NCT04227340|143146087|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71822173|NCT04227340|143146089|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71822174|NCT04227340|143146091|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.1
71822175|NCT04227340|143146093|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71822176|NCT03785340|143146150|SUPERIORITY|"The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found:~1. Change from baseline to 4 weeks (Day 28) in SANDE score~2. Change from baseline to 4 weeks (Day 28) in Lissamine Green conjunctival staining scores~3. Change from baseline to 2 weeks (Day 14) in SANDE score~4. Change from baseline to 2 weeks (Day 14) in Lissamine Green conjunctival staining scores"|Least squares mean difference|-0.844||||0.739|TWO_SIDED|95.0|-5.823|4.134|||Mixed Model Repeated Measures Analysis||Change from baseline to 4 weeks (Day 28) in SANDE score; OCU-310 vs. Placebo|Four endpoints (two primary and two secondary) were to be tested in a fixed sequence, proceeding to the next endpoint until a p-value \>0.05 was found. The analysis of the four outcomes employed a repeated measures mixed model with mean change from baseline score at the stated time point as the response with baseline score as a covariate and treatment, visit, and their interaction as fixed effects. The least squares mean difference (OCU 310 - placebo) at the stated time point was tested.||4.134|-5.823|0.739
71904824|NCT00543569|143331054|SUPERIORITY_OR_OTHER||Difference|10.7|||||TWO_SIDED|90.0|0.9|20.4||||||Efficacy Failure at Month 6||20.4|0.9|
71854400|NCT02799745|143222905|SUPERIORITY||Odds Ratio (OR)|1.1||||0.807|TWO_SIDED|95.0|0.37|3.53||P-value: based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of month 24||3.53|0.37|0.807
71854401|NCT02799745|143222905|SUPERIORITY||Odds Ratio (OR)|1.0||||0.931|TWO_SIDED|95.0|0.5|2.15||P-value:based on the exact binomial distribution from the logistic regression model.|Regression, Logistic||OR: from logistic regression model where treatment group, prostate cancer risk, type of biopsy, age, race and time since prostate cancer diagnosis were fixed covariates, site and participant were random effects. 95% CI:based on binomial distribution.|At the end of study||2.15|0.50|0.931
71854402|NCT02329223|143222987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.7|STANDARD_ERROR_OF_MEAN|0.815|<|0.001|TWO_SIDED|95.0|-5.31|-2.098|||Mixed Model with repeated measures(MMRM)|||||-2.098|-5.310|<0.001
71854403|NCT02329223|143222987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.29|STANDARD_ERROR_OF_MEAN|0.828||0.006|TWO_SIDED|95.0|-3.921|-0.654|||Mixed Model with repeated measures(MMRM)|||||-0.654|-3.921|0.006
71854404|NCT02924350|143222996|OTHER||Least square (LS) mean difference|-0.924|||<|0.0001|TWO_SIDED|95.0|-1.0547|-0.7927|||ANCOVA|ANCOVA: change from baseline in Schiff sensitivity score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.|||-0.7927|-1.0547|<.0001
71854405|NCT00097708|143222999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.654|TWO_SIDED|95.0|-2.2|1.4|||ANCOVA|||||1.4|-2.2|0.6540
71854406|NCT00097708|143222999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2||||0.0005|TWO_SIDED|95.0|-5.0|-1.4|||ANCOVA|||||-1.4|-5.0|0.0005
71854407|NCT00097708|143222999|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.8||||0.0015|TWO_SIDED|95.0|1.1|4.5|||ANCOVA|||||4.5|1.1|0.0015
71854408|NCT01231464|143223003|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.498|||<|0.0001|TWO_SIDED|95.0|-1.897|-1.009|||ANCOVA||Besides treatment, the ANCOVA analysis also adjusted for baseline, center, gender, age, and classification of AR (Intermittent Allergic Rhinitis \[IAR\] or Persistent Allergic Rhinitis \[PER\]).|||-1.009|-1.897|<0.0001
71854409|NCT01589523|143223014|EQUIVALENCE|paired t-test||||||0.342|||||||t-test, 2 sided|||||||0.342
71854410|NCT01589523|143223015|EQUIVALENCE|paired t-test||||||0.116|||||||t-test, 2 sided|||||||0.116
71854411|NCT01589523|143223016|EQUIVALENCE|paired t-test||||||0.065|||||||t-test, 2 sided|vitamin D||||||0.065
71854412|NCT02507687|143223034|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.24||0.0231|TWO_SIDED|95.0|-1.03|-0.08|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||-0.08|-1.03|0.0231
71854413|NCT02507687|143223035|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1615|TWO_SIDED|95.0|-1.04|0.18|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.18|-1.04|0.1615
71854414|NCT02507687|143223036|NON_INFERIORITY|"Statistical non-inferiority of Bimatoprost SR 10 µg to SLT was demonstrated if the upper limit of the 95% confidence interval (CI) for the least squares (LS) mean difference between the Bimatoprost SR 10 µg eyes and SLT eyes was ≤ 1.5 mmHg at Weeks 4, 12, and 24.~Clinical non-inferiority of Bimatoprost SR 10 µg to SLT was considered if the upper limit of the 95% CI was ≤ 1.0 mmHg at 2 out of the 3 visits of Weeks 4, 12, and 24."|LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.1673|TWO_SIDED|95.0|-0.97|0.17|||Mixed Effect Model Repeated Measurement|The model includes treatment, visit, eye, baseline IOP, treatment-by-visit, visit-by-baseline, and visit-by-eyes interactions as covariates.||||0.17|-0.97|0.1673
71854415|NCT02675998|143223040|SUPERIORITY|||||||0.01|||||||ANCOVA|||||||0.01
71854416|NCT02675998|143223041|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71854417|NCT02675998|143223041|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71854418|NCT02675998|143223041|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71854419|NCT04357964|143223042|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups at baseline in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.|||||<|0.01||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||<0.01
71854420|NCT04357964|143223043|EQUIVALENCE|Statistical significance was defined as p \< 0.05. There was no intervention in this study, so there is no true equivalence margin.|||||<|0.01|||||||Pearson correlation|||||||<0.01
71854421|NCT04357964|143223044|EQUIVALENCE|Statistical significance was defined as p\< 0.05 for determining difference between groups in this observational study. There was no treatment intervention in this study, so there is no true equivalence margin.||||||0.52||||||Statistical significance was defined as p\< 0.05|Kruskal-Wallis|||||||0.52
71854422|NCT02288364|143223054|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Chi-squared|||||||0.30
71854423|NCT02288364|143223055|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Chi-squared|||||||0.08
71854424|NCT02288364|143223056|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Chi-squared|||||||0.29
71854425|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.87|||<|0.001||95.0|4.59|7.16|||ANCOVA|||||7.16|4.59|<0.001
71904825|NCT00543569|143331054|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-4.5|13.7||||||Efficacy Failure at Month 6||13.7|-4.5|
71904826|NCT00543569|143331054|SUPERIORITY_OR_OTHER||Difference|9.1|||||TWO_SIDED|90.0|-0.4|18.7||||||Efficacy Failure at Month 6||18.7|-0.4|
71904827|NCT00543569|143331054|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|90.0|-4.0|18.0||||||Efficacy Failure at Month 12||18.0|-4.0|
71904828|NCT00543569|143331054|SUPERIORITY_OR_OTHER||Difference|2.3|||||TWO_SIDED|90.0|-8.3|13.0||||||Efficacy Failure at Month 12||13.0|-8.3|
71904829|NCT00543569|143331054|SUPERIORITY_OR_OTHER||Difference|6.7|||||TWO_SIDED|90.0|-4.2|17.6||||||Efficacy Failure at Month 12||17.6|-4.2|
71904830|NCT00543569|143331064|SUPERIORITY_OR_OTHER||Difference|11.1|||||TWO_SIDED|90.0|-1.1|23.3||||||Treatment Failure at Month 6||23.3|-1.1|
71904831|NCT00543569|143331064|SUPERIORITY_OR_OTHER||Difference|11.8|||||TWO_SIDED|90.0|-0.7|24.2||||||Treatment Failure at Month 6||24.2|-0.7|
71904832|NCT00543569|143331064|SUPERIORITY_OR_OTHER||Difference|2.9|||||TWO_SIDED|90.0|-8.9|14.7||||||Treatment Failure at Month 6||14.7|-8.9|
71904833|NCT00543569|143331064|SUPERIORITY_OR_OTHER||Difference|10.0|||||TWO_SIDED|90.0|-2.9|22.8||||||Treatment Failure at Month 12||22.8|-2.9|
71904834|NCT00543569|143331064|SUPERIORITY_OR_OTHER||Difference|9.7|||||TWO_SIDED|90.0|-3.3|22.8||||||Treatment Failure at Month 12||22.8|-3.3|
71904835|NCT00543569|143331064|SUPERIORITY_OR_OTHER||Difference|-0.8|||||TWO_SIDED|90.0|-13.3|11.7||||||Treatment Failure at Month 12||11.7|-13.3|
71904836|NCT01098461|143331119|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-0.89|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.57|||t-test, 2 sided|||||-0.57|-1.22|<0.0001
71904837|NCT01098461|143331119|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.55|||<|0.0001|TWO_SIDED|95.0|-1.88|-1.23|||t-test, 2 sided|||||-1.23|-1.88|<0.0001
71904838|NCT01098461|143331119|NON_INFERIORITY_OR_EQUIVALENCE|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.43|-0.78|||t-test, 2 sided|||||-0.78|-1.43|<0.0001
71904839|NCT01968187|143331132|OTHER||LS Mean Difference|-6.7||||0.029|ONE_SIDED|90.0||-2.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effect and HPWSQ-R total score at baseline as covariate.||||-2.2||0.0290
71904840|NCT01968187|143331133|OTHER||LS Mean Difference|-0.8||||0.0233|ONE_SIDED|90.0||-0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and CGI-S score as a covariate.||||-0.3||0.0233
71904841|NCT01968187|143331134|OTHER||LS Mean Difference|-2.0||||0.1172|ONE_SIDED|90.0||0.2|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score at baseline as a covariate.||HPWSQ-R Domain score: Behavior||0.2||0.1172
71904842|NCT01968187|143331134|OTHER||LS Mean Difference|-1.6||||0.1436|ONE_SIDED|90.0||0.3|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Drive||0.3||0.1436
71904843|NCT01968187|143331134|OTHER||LS Mean Difference|-1.5||||0.0248|ONE_SIDED|90.0||-0.5|||ANCOVA|Treatment groups were compared using ANCOVA model with treatment and site as fixed effects and HPWSQ-R domain score -at baseline as a covariate.||HPWSQ-R Domain score: Severity||-0.5||0.0248
71904844|NCT01968187|143331135|OTHER||LS mean difference|-6.2||||0.0047|ONE_SIDED|90.0||-3.3|||ANCOVA|From ANCOVA model with treatment and site as fixed effects and CY-BOCS total score at baseline as a covariate.||||-3.3||0.0047
71904845|NCT01968187|143331136|OTHER||LS mean difference|-4.4||||0.0132|ONE_SIDED|90.0||-1.9|||ANCOVA|Compared using ANCOVA model with treatment and site as fixed effects and Food Domain Score of Reiss Profile at baseline as a covariate.||||-1.9||0.0132
71904846|NCT04095286|143331137|OTHER||Ratio of adjusted geometric mean|1.03|||||TWO_SIDED|90.0|0.96|1.11|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.11|0.96|
71904847|NCT04095286|143331137|OTHER||Ratio of adjusted geometric mean|0.91|||||TWO_SIDED|90.0|0.85|0.98|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||0.98|0.85|
71904848|NCT04095286|143331140|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.09|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.09|1.02|
71904849|NCT04095286|143331140|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.0|1.08|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.00|
71904850|NCT04095286|143331141|OTHER||Ratio of adjusted geometric mean|1.05|||||TWO_SIDED|90.0|1.02|1.08|||||Treatment comparison between AMB dispersed in water and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.08|1.02|
71904851|NCT04095286|143331141|OTHER||Ratio of adjusted geometric mean|1.04|||||TWO_SIDED|90.0|1.01|1.07|||||Treatment comparison between AMB oral tablet and reference AMB tablet using ratio of adjusted geometric mean and its corresponding 90% confidence interval has been presented|||1.07|1.01|
71854426|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|5.01|7.65|||ANCOVA|||||7.65|5.01|<0.001
71854427|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|||<|0.001||95.0|4.07|6.64|||ANCOVA|||||6.64|4.07|<0.001
71854428|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.84|||<|0.001||95.0|2.6|5.07|||ANCOVA|||||5.07|2.60|<0.001
71854429|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||<|0.001||95.0|6.13|8.87|||ANCOVA|||||8.87|6.13|<0.001
71854430|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.52|||<|0.001||95.0|4.19|6.85|||ANCOVA|||||6.85|4.19|<0.001
71854431|NCT00043186|143223063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||<|0.001||95.0|3.88|6.55|||ANCOVA|||||6.55|3.88|<0.001
71854432|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854433|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854434|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71904852|NCT00839423|143331174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-8.49|-2.91||"A hierarchical hypothesis testing procedure was used. The comparison of 10 mg to placebo was primary.~Since p-value was \<0.05, hierarchically testing continued."|ANCOVA|||"The statistical model was an analysis of covariance (ANCOVA) of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 6.~With 96 patients in each treatment arm and a standard deviation of 9 points, the power to detect a true effect of 3.7 points on the MADRS total score at Week 6 will be 80%."||-2.91|-8.49|<0.0001
71904853|NCT00839423|143331174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.64|-3.17||"The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo.~Since p-value \<0.05, hierarchically testing contd."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6."||-3.17|-8.64|<0.0001
71904854|NCT00839423|143331174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.13|-3.72||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||-3.72|-9.13|<0.0001
71854435|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854436|NCT00043186|143223064|SUPERIORITY_OR_OTHER|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
71854437|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854438|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854439|NCT00043186|143223064|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854440|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854441|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854442|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854443|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854444|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854445|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854446|NCT00043186|143223065|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71854447|NCT00043186|143223065|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854448|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.34|||<|0.001||95.0|5.56|9.12|||ANCOVA|||||9.12|5.56|<0.001
71854449|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.11|||<|0.001||95.0|7.31|10.91|||ANCOVA|||||10.91|7.31|<0.001
71854450|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.56|||<|0.001||95.0|6.71|10.41|||ANCOVA|||||10.41|6.71|<0.001
71854451|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.44|||<|0.001||95.0|6.69|10.19|||ANCOVA|||||10.19|6.69|<0.001
71854452|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|3.43|6.94|||ANCOVA|||||6.94|3.43|<0.001
71854453|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.08|||<|0.001||95.0|8.14|12.01|||ANCOVA|||||12.01|8.14|<0.001
71854454|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.46|||<|0.001||95.0|6.62|10.3|||ANCOVA|||||10.30|6.62|<0.001
71854455|NCT00043186|143223067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.66|||<|0.001||95.0|6.8|10.53|||ANCOVA|||||10.53|6.80|<0.001
71854456|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|4.32|8.67|||ANCOVA|||||8.67|4.32|<0.001
71854457|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.65||||0.013||95.0|0.55|4.75|||ANCOVA|||||4.75|0.55|0.013
71854458|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.43|||<|0.001||95.0|10.19|14.68|||ANCOVA|||||14.68|10.19|<0.001
71854459|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|||<|0.001||95.0|8.74|12.94|||ANCOVA|||||12.94|8.74|<0.001
71854460|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|||<|0.001||95.0|7.69|11.89|||ANCOVA|||||11.89|7.69|<0.001
71854461|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.37|6.12|||ANCOVA|||||6.12|1.37|<0.001
71854462|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.97|||<|0.001||95.0|8.63|13.32|||ANCOVA|||||13.32|8.63|<0.001
71822177|NCT02923895|143146154|SUPERIORITY|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|Mean Difference (Net)|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.128||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-1.128|-1.500|<.0001
71822178|NCT03552978|143146160|SUPERIORITY||Odds Ratio (OR)|11.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df - 63||||||<.001
71822179|NCT03552978|143146161|SUPERIORITY||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED||||||t-test, 2 sided|df = 59||||||<.001
71822180|NCT03552978|143146165|SUPERIORITY||Mean Difference (Final Values)|90.28||||0.39|TWO_SIDED||||||Mixed Models Analysis|df = 3, 152.11||We examined total Cigarettes smoked in the past 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in cigarette use over time by treatment group.||||.39
71822181|NCT03552978|143146166|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.91|TWO_SIDED||||||Mixed Models Analysis|df = 3, 140.87||We examined days of e-cigarette use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in e-cigarette use over time by treatment group.||||.91
71822182|NCT03552978|143146167|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.66|TWO_SIDED||||||Mixed Models Analysis|df = 3,199||We examined days of chewing tobacco use in the previous 30 days using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in chewing tobacco use over time by treatment group.||||.66
71822183|NCT03552978|143146168|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.76|TWO_SIDED||||||Mixed Models Analysis|df = 3, 102.04||We examined nicotine dependence using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in nicotine dependence over time by treatment group.||||.76
71822184|NCT03552978|143146169|SUPERIORITY||Odds Ratio (OR)|1.99||||0.28|TWO_SIDED|||||Week 12|Chi-squared|df = 1||||||.28
71822185|NCT03552978|143146169|SUPERIORITY||Odds Ratio (OR)|2.3||||0.19|TWO_SIDED|||||Week 24|Chi-squared|df = 1||||||.19
71822186|NCT03552978|143146170|SUPERIORITY||Odds Ratio (OR)|1.68||||0.42|TWO_SIDED||||||Chi-squared|df = 1||Week 12||||.42
71822187|NCT03552978|143146170|SUPERIORITY||Odds Ratio (OR)|2.52||||0.17|TWO_SIDED||||||Chi-squared|df = 1||Week 24||||.17
71822188|NCT03552978|143146171|SUPERIORITY||Mean Difference (Final Values)|3.66||||0.58|TWO_SIDED||||||Mixed Models Analysis|df = 3, 100.51||We examined days of changes in PTSD symptoms using linear mixed models to account for non-independence (longitudinal data) and missing data. The null hypothesis was that the time by treatment group interaction would equal zero, indicating no difference in the change in PTSD symptoms over time by treatment group.||||.58
71822189|NCT01670500|143146180|OTHER||Risk Ratio (RR)|0.7|||||TWO_SIDED|90.0|0.39|1.2|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.2|0.39|
71822190|NCT01670500|143146181|OTHER||Risk Ratio (RR)|0.73|||||TWO_SIDED|90.0|0.5|1.1|||||The risk ratio is comparing cisplatin to doxorubicin-cyclophosphamide (AC)|||1.1|.5|
71822191|NCT04951479|143146235|SUPERIORITY|||||||0.00041|||||||t-test, 2 sided|||Paired t-test of KOOS Pain score pre and 6 months post embolization||||0.00041
71822192|NCT04951479|143146236|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71822193|NCT04951479|143146237|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71822194|NCT04951479|143146238|SUPERIORITY|||||||0.00797|||||||t-test, 2 sided|paired t-test||||||0.00797
71822195|NCT02711826|143146245|SUPERIORITY|||||||0.425|||||||Fisher Exact|||||||0.425
71822196|NCT02711826|143146246|SUPERIORITY|||||||0.7|||||||Kruskal-Wallis|||||||0.700
71822197|NCT02711826|143146247|SUPERIORITY|||||||0.201|||||||Kruskal-Wallis|||||||0.201
71822198|NCT04019561|143146290|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.439|TWO_SIDED|95.0|-5.02|2.2|||ANCOVA|||||2.20|-5.02|0.439
71822199|NCT04019561|143146290|SUPERIORITY||Mean Difference (Final Values)|-5.01||||0.006|TWO_SIDED|95.0|-8.54|-1.48|||ANCOVA|||||-1.48|-8.54|0.006
71822200|NCT04019561|143146291|SUPERIORITY||Mean Difference (Final Values)|-1.508||||0.695|TWO_SIDED|95.0|-9.191|6.174|||ANCOVA|||||6.174|-9.191|0.695
71822201|NCT04019561|143146291|SUPERIORITY||Mean Difference (Final Values)|-9.291||||0.016|TWO_SIDED|95.0|-16.76|-1.822|||ANCOVA|||||-1.822|-16.760|0.016
71822202|NCT04019561|143146292|SUPERIORITY||Mean Difference (Final Values)|-10.74||||0.468|TWO_SIDED|95.0|-40.174|18.695|||ANCOVA|||||18.695|-40.174|0.468
71822203|NCT04019561|143146292|SUPERIORITY||Mean Difference (Final Values)|-37.395||||0.012|TWO_SIDED|95.0|-66.38|-8.409|||ANCOVA|||||-8.409|-66.380|0.012
71822204|NCT04019561|143146293|SUPERIORITY||Mean Difference (Final Values)|6.26||||0.166|TWO_SIDED|95.0|-2.698|15.218|||ANCOVA|||||15.218|-2.698|0.166
71822205|NCT04019561|143146293|SUPERIORITY||Mean Difference (Final Values)|0.749||||0.856|TWO_SIDED|95.0|-7.537|9.035|||ANCOVA|||||9.035|-7.537|0.856
71822206|NCT04019561|143146294|SUPERIORITY||Mean Difference (Final Values)|-3.283||||0.302|TWO_SIDED|95.0|-9.641|3.076|||ANCOVA|||||3.076|-9.641|0.302
71822207|NCT04019561|143146294|SUPERIORITY||Mean Difference (Final Values)|-2.821||||0.304|TWO_SIDED|95.0|-8.316|2.675|||ANCOVA|||||2.675|-8.316|0.304
71822208|NCT04019561|143146295|SUPERIORITY||Mean Difference (Final Values)|1.038||||0.808|TWO_SIDED|95.0|-7.493|9.569|||ANCOVA|||||9.569|-7.493|0.808
71822209|NCT04019561|143146295|SUPERIORITY||Mean Difference (Final Values)|1.106||||0.786|TWO_SIDED|95.0|-7.043|9.255|||ANCOVA|||||9.255|-7.043|0.786
71822210|NCT04019561|143146296|SUPERIORITY||Mean Difference (Final Values)|3.448||||0.087|TWO_SIDED|95.0|-0.524|7.421|||ANCOVA|||||7.421|-0.524|0.087
71822211|NCT04019561|143146296|SUPERIORITY||Mean Difference (Final Values)|-0.387||||0.834|TWO_SIDED|95.0|-4.085|3.312|||ANCOVA|||||3.312|-4.085|0.834
71822212|NCT04019561|143146297|SUPERIORITY||Mean Difference (Final Values)|-0.386||||0.735|TWO_SIDED|95.0|-2.681|1.908|||ANCOVA|||||1.908|-2.681|0.735
71822213|NCT04019561|143146297|SUPERIORITY||Mean Difference (Final Values)|-1.091||||0.308|TWO_SIDED|95.0|-3.226|1.044|||ANCOVA|||||1.044|-3.226|0.308
71680785|NCT03408444|142880087|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|-0.01|0.25|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.25|-0.01|
71680786|NCT03408444|142880087|SUPERIORITY|Superiority is established if the adjusted lower confidence limit is above 0.|Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.054|||TWO_SIDED|95.0|0.09|0.35|||Mixed Models Analysis|Kenward and Roger method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|It was calculated that 160 participants randomized in a 1:1:1:1 fashion among the four arms would have at least 79% power to detect a 0.20 D difference in mean axial elongation at the 6-month follow-up. The power analysis was conducted controlling 2-sided type I error of 0.05.||0.35|0.09|
71680787|NCT01473394|142880089|SUPERIORITY_OR_OTHER||Least square mean difference|-5.117|||<|1e-05|TWO_SIDED|95.0|-6.886|-3.347|||Mixed-effects model for repeated measure|||||-3.347|-6.886|<0.00001
71680788|NCT01473394|142880090|SUPERIORITY_OR_OTHER||Least square mean difference|-0.622|||<|1e-05|TWO_SIDED|95.0|-0.845|-0.399|||Mixed-effects model for repeated measure|||||-0.399|-0.845|<0.00001
71680789|NCT01473394|142880091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.2||||0.0047|TWO_SIDED|95.0|3.0|17.4|||Cochran-Mantel-Haenszel||The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.|||17.4|3.0|0.0047
71680790|NCT02901275|142880096|SUPERIORITY|||||||0.61||||||No covariate or correction for multiple comparisons. a priori statistical threshold is p\<.05|Mixed Models Analysis|||||||0.61
71680791|NCT02901275|142880097|SUPERIORITY||||||<|0.0001||||||No covariates or correction for multiple comparisons. a priori threshold is p\<.05.|Mixed Models Analysis|||||||<.0001
71680792|NCT02901275|142880098|SUPERIORITY|||||||0.51||||||No covariate or correction for multiple comparisons. a priori threshold for significance is p\<.05|Mixed Models Analysis|||||||0.51
71822214|NCT04019561|143146298|SUPERIORITY||Mean Difference (Final Values)|-19.277||||0.195|TWO_SIDED|95.0|-48.704|10.15|||ANCOVA|||||10.150|-48.704|0.195
71822215|NCT04019561|143146298|SUPERIORITY||Mean Difference (Final Values)|-24.328||||0.103|TWO_SIDED|95.0|-53.674|5.019|||ANCOVA|||||5.019|-53.674|0.103
71822216|NCT04019561|143146299|SUPERIORITY||Mean Difference (Final Values)|-10.39||||0.6|TWO_SIDED|95.0|-49.802|29.022|||ANCOVA|||||29.022|-49.802|0.600
71822217|NCT04019561|143146299|SUPERIORITY||Mean Difference (Final Values)|7.086||||0.72|TWO_SIDED|95.0|-32.163|46.336|||ANCOVA|||||46.336|-32.163|0.720
71854463|NCT00043186|143223068|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.37|||<|0.001||95.0|8.16|12.59|||ANCOVA|||||12.59|8.16|<0.001
71680793|NCT04450407|142880140|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% CI (Confidence Interval) is below 0.4.|LS Mean Difference|0.17|||||TWO_SIDED|90.0|0.01|0.32||||||||0.32|0.01|
71680794|NCT02832375|142880152|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.45|||<|0.0001|TWO_SIDED|95.0|-0.577|-0.319|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|H0= no difference between experimental dentifrice and control dentifrice H1= a difference between experimental dentifrice and control dentifrice||-0.319|-0.577|<0.0001
71680795|NCT06350461|142880155|NON_INFERIORITY|The non-inferiority margin is -3.|Median Difference (Final Values)|-0.324|||<|0.0001|TWO_SIDED|95.0|-1.3|0.6||One-sided test for non-inferiority|ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|The non-inferiority test was a priori designed to be conducted on the per-protocol (PP) population.||0.6|-1.3|<0.0001
71680796|NCT06350461|142880156|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.733|TWO_SIDED|95.0|-0.4|0.4|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue|||0.4|-0.4|0.733
71680797|NCT06350461|142880157|SUPERIORITY||Mean Difference (Final Values)|-1.52||||0.226|TWO_SIDED|95.0|-4.1|0.9|||ANOVA|Adjusted for four dichotomous randomization strata.|Direction of difference is Discontinue - Continue.|||0.9|-4.1|0.226
71680798|NCT06350461|142880158|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.857|TWO_SIDED|95.0|-1.8|2.1|||ANOVA|Adjusted for four dichotomous randomization strata|Direction of the difference is Discontinue - Continue|||2.1|-1.8|0.857
71680799|NCT06350461|142880159|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.16|TWO_SIDED|95.0|-0.25|1.54|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||1.54|-0.25|0.16
71822218|NCT04019561|143146300|SUPERIORITY||Mean Difference (Final Values)|-9.14||||0.485|TWO_SIDED|95.0|-35.134|16.854|||ANCOVA|||||16.854|-35.134|0.485
71822219|NCT04019561|143146300|SUPERIORITY||Mean Difference (Final Values)|-19.645||||0.131|TWO_SIDED|95.0|-45.288|5.999|||ANCOVA|||||5.999|-45.288|0.131
71822220|NCT04019561|143146301|SUPERIORITY||Mean Difference (Final Values)|-0.719||||0.564|TWO_SIDED|95.0|-3.191|1.754|||ANCOVA|||||1.754|-3.191|0.564
71854464|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42||||0.02||95.0|0.89|9.95|||ANCOVA|||||9.95|0.89|0.02
71822221|NCT04019561|143146301|SUPERIORITY||Mean Difference (Final Values)|-2.366||||0.062|TWO_SIDED|95.0|-4.854|0.122|||ANCOVA|||||0.122|-4.854|0.062
71822222|NCT04019561|143146302|SUPERIORITY||Mean Difference (Final Values)|-0.084||||0.856|TWO_SIDED|95.0|-1.007|0.838|||ANCOVA|||||0.838|-1.007|0.856
71822223|NCT04019561|143146302|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.098|TWO_SIDED|95.0|-1.7|0.147|||ANCOVA|||||0.147|-1.700|0.098
71822224|NCT02320721|143146320|NON_INFERIORITY|Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<0.3%.|LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.056|||TWO_SIDED|95.0|-0.092|0.129||||||Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.||0.129|-0.092|
71854465|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.992||95.0|-5.07|5.02|||ANCOVA|||||5.02|-5.07|0.992
71854466|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9||||0.004||95.0|3.72|14.09|||ANCOVA|||||14.09|3.72|0.004
71822225|NCT02320721|143146321|SUPERIORITY_OR_OTHER_LEGACY|A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.|Relative risk|1.01||||0.8415|TWO_SIDED|95.0|0.89|1.153||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c \[\<8.0%; ≥8.0%\], previous use of insulin \[naive, pre-treated\], use of sulfonylurea or meglitinides at screening \[yes, no\]), following multiple imputation procedure for missing data.||1.153|0.890|0.8415
71822226|NCT03317379|143146407|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.17|0.22||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.22|-0.17|.80
71822227|NCT03317379|143146407|SUPERIORITY||estimate of fixed effects|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.32|TWO_SIDED|95.0|-0.1|0.3||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.30|-0.10|.32
71822228|NCT03317379|143146408|SUPERIORITY||estimate of fixed effects|0.14|STANDARD_ERROR_OF_MEAN|0.05||0.01|TWO_SIDED|95.0|0.03|0.24||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.24|0.03|0.01
71822229|NCT03317379|143146408|SUPERIORITY||estimate of fixed effects|0.08|STANDARD_ERROR_OF_MEAN|0.07||0.28|TWO_SIDED|95.0|-0.07|0.23||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.23|-.07|0.28
71822230|NCT03317379|143146409|SUPERIORITY||estimate of fixed effects|0.61|STANDARD_ERROR_OF_MEAN|0.28||0.03|TWO_SIDED|95.0|0.06|1.16||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||1.16|0.06|0.03
71822231|NCT03317379|143146409|SUPERIORITY||estimate of fixed effects|0.68|STANDARD_ERROR_OF_MEAN|0.29||0.02|TWO_SIDED|95.0|0.09|1.27|||Mixed Models Analysis|||||1.27|0.09|0.02
71822232|NCT03317379|143146410|SUPERIORITY||estimate of fixed effects|0.2|STANDARD_ERROR_OF_MEAN|0.11||0.08|TWO_SIDED|95.0|-0.02|0.42||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.42|-0.02|0.08
71822233|NCT03317379|143146410|SUPERIORITY||estimate of fixed effects|0.18|STANDARD_ERROR_OF_MEAN|0.12||0.12|TWO_SIDED|95.0|-0.04|0.41||.05 is the a priori threshold for statistical significance.|Mixed Models Analysis|||||0.41|-0.04|0.12
71822234|NCT03317379|143146411|SUPERIORITY||estimate of fixed effects|0.03|STANDARD_ERROR_OF_MEAN|0.22||0.18|TWO_SIDED|95.0|-0.14|0.74||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.74|-0.14|0.18
71822236|NCT01682538|143146459|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.858|||||TWO_SIDED|90.0|0.81|0.91|||ANOVA|||||0.91|0.81|
71822237|NCT01682538|143146460|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.954|||||TWO_SIDED|90.0|0.85|1.07|||ANOVA|||||1.07|0.85|
71822235|NCT03317379|143146411|SUPERIORITY||estimate of fixed effects|0.16|STANDARD_ERROR_OF_MEAN|0.23||0.5|TWO_SIDED|95.0|-0.3|0.62||the a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|||||0.62|-0.30|0.50
71822238|NCT01682538|143146461|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25).|Ratio of geometric means|1.013|||||TWO_SIDED|90.0|0.96|1.07|||ANOVA|||||1.07|0.96|
71822239|NCT01682538|143146462|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25)|Ratio of geometric means|0.802|||||TWO_SIDED|90.0|0.71|0.9|||ANOVA|||||0.90|0.71|
71822240|NCT00802841|143146473|SUPERIORITY_OR_OTHER|||||||0.3106|TWO_SIDED||||||Fisher Exact|||||||0.3106
71822241|NCT00377741|143146499|SUPERIORITY_OR_OTHER||Mean exposure ratio for AUC(0-tau)|1.24|||||TWO_SIDED|90.0|0.98|1.55||||||||1.55|0.98|
71822242|NCT00377741|143146500|SUPERIORITY_OR_OTHER||Mean exposure ratio for Cmax|1.12|||||TWO_SIDED|90.0|0.88|1.42||||||||1.42|0.88|
71904855|NCT00839423|143331175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.69||0.2377|TWO_SIDED|95.0|-2.17|0.54||"The hierarchical procedure meant that the above hypothesis was tested at a 5% significance level since significance was achieved for both 10 and 5 mg at Week 6.~Since p-value was \>0.05, hierarchically testing stopped here."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 1."||0.54|-2.17|0.2377
71904856|NCT00839423|143331175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.67||0.7489|TWO_SIDED|95.0|-1.54|1.11||The hierarchical procedure meant that the above hypothesis was not tested since significance was not achieved for 10 mg at Week 1. A nominal p-value is provided.|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 1."||1.11|-1.54|0.7489
71822243|NCT03019458|143146597|SUPERIORITY|||||||0.084||||||The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p\<0.05.|Mixed Models Analysis|We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).||||||0.084
71822244|NCT02033993|143146601|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.31|TWO_SIDED|90.0|0.68|1.23||1-sided p-value|Log Rank|||||1.23|0.68|0.31
71822245|NCT02033993|143146602|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.4|TWO_SIDED|90.0|0.7|1.3||1-sided p-value|Log Rank|||||1.30|0.70|0.40
71822246|NCT02033993|143146603|SUPERIORITY||Odds Ratio (OR)|1.41||||0.28|TWO_SIDED|95.0|0.76|2.59|||Cochran-Mantel-Haenszel|||||2.59|0.76|0.28
71822247|NCT02033993|143146604|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.54|TWO_SIDED|95.0|0.46|1.51|||Log Rank|||||1.51|0.46|0.54
71822248|NCT01561079|143146612|SUPERIORITY_OR_OTHER|||||||0.001||||||The p values were not adjusted for multiplicity The a priori threshold = .05|Hierarchical Linear Modeling|The p-value was calculated||||||0.001
71822249|NCT01561079|143146613|SUPERIORITY_OR_OTHER||||||<|0.002|||||||Hierarchical Linear Modeling|||||||<.002
71822250|NCT01561079|143146614|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Hierarchical Linear Modeling|||||||0.0001
71822251|NCT01561079|143146615|SUPERIORITY_OR_OTHER|||||||0.008|||||||Hierarchical Linear Modeling|The reported p-value was calculated||||||.008
71822252|NCT01561079|143146616|SUPERIORITY_OR_OTHER|||||||0.002|||||||Hierarchical Linear Modeling|||||||.002
71822253|NCT01207934|143146623|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||ANOVA for reapeated measures was used to compare the three groups.|ANOVA|||The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.||||>0.05
71822254|NCT01207934|143146624|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|T-tests compared pre and post-treatment values.||The null hypothesis is that treatment would not effect plasma leptin levels.||||<0.01
71822255|NCT01207934|143146624|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||a priori threshold for significance was p = 0.05.|t-test, 2 sided|||null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.||||<0.01
71822256|NCT00688259|143146693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||||||.30
71822257|NCT00688259|143146694|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|||||||Mixed Models Analysis|||||||.09
71822258|NCT00688259|143146695|SUPERIORITY_OR_OTHER_LEGACY|||||||0.46|||||||Mixed Models Analysis|||||||.46
71822259|NCT00688259|143146696|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Mixed Models Analysis|||||||.55
71822260|NCT00688259|143146697|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||||||.50
71904857|NCT00839423|143331175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.67||0.4142|TWO_SIDED|95.0|-0.77|1.85||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA|||||1.85|-0.77|0.4142
71904858|NCT00839423|143331176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.28|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|-7.69|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.69|<0.0001
71822261|NCT00688259|143146698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|||||||Mixed Models Analysis|||||||.25
71822262|NCT02954575|143146699|OTHER||Poisson test estimate|2.13|||<|0.0001|TWO_SIDED|95.0|1.64|2.76||versus mean TABR \>29|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualized bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the TABR reported in the GENA-01 study (NCT00989196), which observed 58.1 BEs per patient per year. A corresponding two-sided 95% CI for the TABR was also analyzed.||2.76|1.64|<0.0001
71822263|NCT02954575|143146700|OTHER||Poisson test estimate|1.53|||<|0.0001|TWO_SIDED|95.0|1.13|2.08||versus mean SABR \>19.1|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean SABR in patients treated prophylactically with Wilate was below the threshold of 19.1 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the SABR in the GENA-01 study (NCT00989196), which observed 38.2 spontaneous BEs per patient per year. A corresponding two-sided 95% CI for the SABR was also analyzed.||2.08|1.13|<0.0001
71822264|NCT02954575|143146701|OTHER||Generalized estimation equation|84.21||||0.0096|TWO_SIDED|95.0|72.13|92.52|||Confirmatory data analysis|||"Confirmatory statistical testing tested the null hypotheses that the percentage of success is ≤70% (alternative hypothesis: percentage \>70%); the test procedure based on the generalized estimation equation took into account several BEs in one patient as correlated repeated measurements (alpha = 2.5%). Thus, π denotes the proportion of success and the following pair of hypotheses was tested:~H0: π ≤ 0.7 vs. H1: π \> 0.7"||92.52|72.13|0.0096
71822265|NCT02954575|143146707|OTHER|||||||0.0346|||||||ANOVA|||||||0.0346
71822266|NCT02954575|143146708|OTHER|||||||0.4244|||||||ANOVA|||||||0.4244
71822267|NCT02954575|143146710|OTHER||Pearson-Copper|0.0|||||TWO_SIDED|95.0|0.0|16.11||||||||16.11|0|
71822268|NCT03890120|143146716|SUPERIORITY||Difference in Percentages|-1.4||||0.4186|TWO_SIDED|95.0|-15.2|12.3|||Mantel Haenszel||The difference of cilofexor and placebo,95% confidence interval(CI),and P value(1-sided)were obtained by the stratum-adjusted Mantel-Haenszel (MH) method,with baseline ursodeoxycholic acid(UDCA)use and Ludwig fibrosis stage as stratification factors.|||12.3|-15.2|0.4186
71822269|NCT03890120|143146721|SUPERIORITY||Difference in Least Squares Mean (LSM)|-4.0||||0.3884|TWO_SIDED|95.0|-28.0|21.0|||ANCOVA||The LSM,95% CI and P-value(1-sided) were obtained by an analysis of covariance(ANCOVA)model with change at Week 96 as dependent variable,baseline value of outcome measure,baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||21|-28|0.3884
71822270|NCT03890120|143146722|SUPERIORITY||Difference in LSM|-9.0||||0.039|TWO_SIDED|95.0|-20.0|1.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1|-20|0.0390
71822271|NCT03890120|143146723|SUPERIORITY||Difference in LSM|-2.6||||0.2845|TWO_SIDED|95.0|-11.6|6.4|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||6.4|-11.6|0.2845
71822272|NCT03890120|143146724|SUPERIORITY||Difference in Percentages|4.1||||0.1978|TWO_SIDED|95.0|-5.3|13.5|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||13.5|-5.3|0.1978
71822273|NCT03890120|143146725|SUPERIORITY||Difference in Percentages|8.9||||0.0797|TWO_SIDED|95.0|-3.5|21.2|||Mantel Haenszel||The difference between cilofexor and Placebo, 95% CI, and the p-value (1-sided) were obtained by the stratum-adjusted MH method, with baseline UDCA use and Ludwig fibrosis stage as stratification factors.|||21.2|-3.5|0.0797
71822274|NCT03890120|143146726|SUPERIORITY||Difference in LSM|1.0||||0.7275|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||3|-1|0.7275
71904859|NCT00839423|143331176|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.33|STANDARD_ERROR_OF_MEAN|1.25|<|0.0001|TWO_SIDED|95.0|-7.79|-2.88||A nominal p-value is provided.|ANCOVA|||||-2.88|-7.79|<0.0001
71680800|NCT06350461|142880160|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.56|TWO_SIDED|95.0|-1.04|0.57|||t-test, 2 sided||Direction of the difference is Discontinue - Continue|||0.57|-1.04|0.56
71680801|NCT06350461|142880161|SUPERIORITY||Difference in % Participants|1.1||||0.653|TWO_SIDED|95.0|-3.7|6.1|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants initiating acute antibiotics is the same in the Discontinue and Continue arms||6.1|-3.7|0.653
71680802|NCT06350461|142880162|SUPERIORITY||Difference in % Participants|0.5||||0.622|TWO_SIDED|95.0|-2.0|3.4|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one hospitalization is the same in Discontinue and Continue arms.||3.4|-2.0|0.622
71680803|NCT06350461|142880163|SUPERIORITY||Difference in % Participants|-1.1||||0.623|TWO_SIDED|95.0|-4.1|1.6|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one protocol-defined pulmonary exacerbation is the same in Discontinue and Continue arms.||1.6|-4.1|0.623
71822275|NCT03890120|143146727|SUPERIORITY||Difference in LSM|-0.03||||0.3636|TWO_SIDED|95.0|-0.2|0.14|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||0.14|-0.20|0.3636
71680804|NCT06350461|142880164|SUPERIORITY||Difference in % Participants|11.7||||0.0165|TWO_SIDED|95.0|2.4|20.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants with at least one AE is the same in Discontinue and Continue arms.||20.7|2.4|0.0165
71822276|NCT03890120|143146728|SUPERIORITY||Difference in LSM|-0.3||||0.3595|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA||The LSM, 95% CI and P-value (1-sided) were obtained by ANCOVA model to evaluate change at Week 96 as the dependent variable, baseline value of the outcome measure, baseline UDCA use, and baseline Ludwig fibrosis stage as independent variables.|||1.5|-2.2|0.3595
71822277|NCT04081298|143146756|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.8||0.24|TWO_SIDED|||||The threshold for statistical significance is p=0.05. (feasibility assessment)|Paired sample t-test|||||||0.24
71680805|NCT06350461|142880165|SUPERIORITY||Rate Ratio|1.29||||0.0958|TWO_SIDED|95.0|0.96|1.74|||Poisson Regression|||Rate ratio, confidence interval, and p-value calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the HS-discontinue and HS-continue arms are 1135.7 and 1163.9 weeks, respectively. Ratio is Discontinue / Continue.||1.74|0.96|0.0958
71822278|NCT04081298|143146757|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.14|STANDARD_DEVIATION|0.78||0.43|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired t-test|||||||0.43
71822279|NCT04081298|143146758|EQUIVALENCE|McNemar's test evaluates equivalence between nominal groups. Power not calculated as this is a feasibility study with small sample size.||||||0.1|||||||McNemar|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.10
71822280|NCT04081298|143146759|EQUIVALENCE|feasibility assessment|Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|0.65||0.2|TWO_SIDED|||||The threshold for statistical significance was p=0.5 (feasibility assessment)|paired-sample t-test|||||||0.20
71822281|NCT04081298|143146760|EQUIVALENCE|paired sample t-test (feasibility assessment)|Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.73||0.71|TWO_SIDED||||||paired sample t-test|||||||0.71
71822282|NCT04081298|143146761|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.94|||||||paired-sample t-test|||Single arm pre-post comparison at baseline and 3-month follow-up (feasibility study)||||0.94
71822283|NCT04081298|143146762|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.03|||||||paired-sample t-test|||||||0.03
71822284|NCT04081298|143146763|EQUIVALENCE|The analysis is an equivalence analysis of change (H1) in mean value from baseline to 3 month follow-up using a paired-sample t-test. Power was not calculated for this analysis because this is a feasibility study. The sample size is not large enough to approach appropriate power.||||||0.36|||||||paired-sample t-test|||||||0.36
71822285|NCT02059161|143146774|NON_INFERIORITY_OR_EQUIVALENCE|The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.|Difference in the Least Squares Means|0.04|||||TWO_SIDED|95.0|-0.11|0.19|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.19|-0.11|
71822286|NCT02059161|143146775|SUPERIORITY_OR_OTHER||Difference in the Percentages|-3.9|||||TWO_SIDED|95.0|-11.8|4.0|||||Miettinen \& Nurminen|||4.0|-11.8|
71822287|NCT02059161|143146776|SUPERIORITY_OR_OTHER||Difference in Percentages|-3.0|||||TWO_SIDED|95.0|-16.1|10.1|||||Miettinen \& Nurminen|||10.1|-16.1|
71822288|NCT02059161|143146779|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.18|0.14|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.14|-0.18|
71822289|NCT02059161|143146780|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.77|||||TWO_SIDED|95.0|-4.69|1.16|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.16|-4.69|
71822290|NCT02059161|143146781|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.06|
71854467|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5||||0.001||95.0|4.15|12.86|||ANCOVA|||||12.86|4.15|0.001
71680806|NCT06350461|142880166|SUPERIORITY||Difference in % Participants|2.17||||0.1215|TWO_SIDED|95.0|-0.7|5.7|||Fisher Exact||Confidence interval calculated using the Newcombe-Wilson method without continuity correction. Direction of difference is Discontinue - Continue.|Null hypothesis: proportion of participants changing assigned regimen is the same in Discontinue and Continue arms.||5.7|-0.7|0.1215
71680807|NCT03301740|142880178|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.5|TWO_SIDED|95.0|0.8|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in intradialytic hypotension between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.7|0.8|0.5
71822291|NCT02059161|143146782|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|9.6|||||TWO_SIDED|95.0|-3.0|22.2|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||22.2|-3.0|
71822292|NCT02059161|143146783|SUPERIORITY_OR_OTHER||Differences in Percentages|-2.1|||||TWO_SIDED|95.0|-9.8|5.5|||||Miettinen \& Nurminen|||5.5|-9.8|
71822293|NCT02059161|143146784|SUPERIORITY_OR_OTHER||Difference in Percentages|0.8|||||TWO_SIDED|95.0|-12.8|14.3|||||Miettinen \& Nurminen|||14.3|-12.8|
71822294|NCT02059161|143146786|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.77|||||TWO_SIDED|95.0|-4.92|1.39|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.39|-4.92|
71822295|NCT02059161|143146787|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.02|||||TWO_SIDED|95.0|-0.05|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.05|
71822296|NCT02059161|143146788|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.4|||||TWO_SIDED|95.0|-19.7|8.9|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.9|-19.7|
71822297|NCT02059161|143146790|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.4|||||TWO_SIDED|95.0|-8.9|8.2|||||Longitudinal data analysis model including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||8.2|-8.9|
71822298|NCT02059161|143146791|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-8.1|||||TWO_SIDED|95.0|-18.6|2.4|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||2.4|-18.6|
71822299|NCT02059161|143146792|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C < 7.0%)|-0.8|||||TWO_SIDED|95.0|-9.7|8.1|||||Miettinen and Nurminen, stratified by prior insulin status.|||8.1|-9.7|
71822300|NCT02059161|143146792|SUPERIORITY_OR_OTHER||Adjusted Difference in %s (A1C <6.5%)|-1.1|||||TWO_SIDED|95.0|-8.6|6.5|||||Miettinen and Nurminen, stratified by prior insulin status.|||6.5|-8.6|
71822301|NCT02059161|143146793|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 7.0%)|0.2|||||TWO_SIDED|95.0|-8.7|9.1|||||Miettinen and Nurminen|||9.1|-8.7|
71822302|NCT02059161|143146793|SUPERIORITY_OR_OTHER||Adjusted Difference (A1C < 6.5%)|-4.4|||||TWO_SIDED|95.0|-11.5|2.8|||||Miettinen and Nurminen|||2.8|-11.5|
71822303|NCT02059161|143146794|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|-0.42|||||TWO_SIDED|95.0|-2.33|1.48|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.48|-2.33|
71822304|NCT02059161|143146795|SUPERIORITY_OR_OTHER||Difference in Least Means Squares|0.0|||||TWO_SIDED|95.0|-0.02|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.02|-0.02|
71822305|NCT02059161|143146796|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.5|||||TWO_SIDED|95.0|-3.69|0.69|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.69|-3.69|
71822306|NCT02059161|143146797|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02||||||95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
71822307|NCT02059161|143146798|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.74|||||TWO_SIDED|95.0|-2.52|1.04|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||1.04|-2.52|
71822308|NCT02059161|143146799|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.01|||||TWO_SIDED|95.0|-0.03|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.03|
71822309|NCT02059161|143146800|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-1.25|||||TWO_SIDED|95.0|-3.34|0.83|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.83|-3.34|
71854468|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37||||0.001||95.0|4.11|12.63|||ANCOVA|||||12.63|4.11|0.001
71680808|NCT03301740|142880179|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-2.8||||0.2|TWO_SIDED|95.0|-6.9|1.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T change between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.4|-6.9|0.2
71680809|NCT03301740|142880180|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.5||||0.1|TWO_SIDED|95.0|0.2|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T rise between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.2|0.1
71680810|NCT03301740|142880181|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Mean Difference (Final Values)|-0.8||||0.2|TWO_SIDED|95.0|-2.0|0.5||Statistically significant p-value is \<0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in left ventricular GLS change between UF profiling and conventional HD. Wilcoxon (Mann-Whitney) tests were performed assessing the difference of the endpoint between the 2 treatment groups.||0.5|-2.0|0.2
71822310|NCT02059161|143146801|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-0.02|||||TWO_SIDED|95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.|||0.01|-0.04|
71822311|NCT01925170|143146820|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Comparison of the two groups for all densities, significant difference p ≤ 0.05.||||<0.001
71822312|NCT01925170|143146820|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Comparison of two groups for all densities; significant difference p ≤ 0.05.||||0.004
71822313|NCT01925170|143146821|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
71822314|NCT01925170|143146821|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.0001
71822315|NCT01925170|143146822|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
71822316|NCT01925170|143146822|SUPERIORITY_OR_OTHER|||||||0.004|||||||McNemar|||Significant difference p ≤ 0.05||||0.004
71822317|NCT01925170|143146823|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||< 0.001
71822318|NCT01925170|143146823|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
71822319|NCT01925170|143146824|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
71822320|NCT01925170|143146824|SUPERIORITY_OR_OTHER||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05||||<0.001
71822321|NCT00577720|143146825|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.437|||||TWO_SIDED|90.0|1.091|1.964||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.964|1.091|
71822322|NCT00577720|143146825|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.507|||||TWO_SIDED|90.0|1.139|2.066||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.066|1.139|
71680811|NCT03301740|142880182|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-0.2||||0.9|TWO_SIDED|95.0|-2.0|1.7||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in nadir systolic BP between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.||1.7|-2.0|0.9
71680812|NCT03301740|142880183|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.8|TWO_SIDED|95.0|0.7|1.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in failed target weight achievement between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.3|0.7|0.8
71680813|NCT03301740|142880184|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.9|TWO_SIDED|95.0|0.4|2.1||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important cramping between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.1|0.4|0.9
71680814|NCT03301740|142880185|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.7||||0.5|TWO_SIDED|95.0|0.2|2.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important nausea/upset stomach between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.2|0.2|0.5
71680815|NCT03301740|142880186|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|16.0|||Mixed Models Analysis|||Null hypothesis = no difference in clinically important Vomiting/throwing up score between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||16.0|0.1|1.0
71680816|NCT03301740|142880187|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.2||||0.04|TWO_SIDED|95.0|0.1|0.9||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important dizziness/lightheadedness between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||0.9|0.1|0.04
71680817|NCT03301740|142880188|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|3.1||||0.3|TWO_SIDED|95.0|0.3|32.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important racing heart/heart palpitations between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||32.4|0.3|0.3
71822323|NCT00577720|143146825|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.535|||||TWO_SIDED|90.0|1.177|2.086||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||2.086|1.177|
71822324|NCT00577720|143146825|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.068|||||TWO_SIDED|90.0|0.867|1.321||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.321|0.867|
71822325|NCT00577720|143146825|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.018|||||TWO_SIDED|90.0|0.824|1.267||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.||1.267|0.824|
71822326|NCT00577720|143146826|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.208|||||TWO_SIDED|90.0|0.749|2.099||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.099|0.749|
71822327|NCT00577720|143146826|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.132|||||TWO_SIDED|90.0|0.665|2.003||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.003|0.665|
71822328|NCT00577720|143146826|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.407|||||TWO_SIDED|90.0|0.913|2.404||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.404|0.913|
71904860|NCT00839423|143331177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.0||0.0011|TWO_SIDED|95.0|-5.27|-1.33||A nominal p-value is provided.|ANCOVA|||||-1.33|-5.27|0.0011
71904861|NCT00839423|143331177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.02||0.0034|TWO_SIDED|95.0|-5.01|-1.0||A nominal p-value is provided.|ANCOVA|||||-1.00|-5.01|0.0034
71822329|NCT00577720|143146826|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.165|||||TWO_SIDED|90.0|0.797|1.752||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.752|0.797|
71904862|NCT00839423|143331178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.28|-0.52||A nominal p-value is provided.|ANCOVA|||||-0.52|-1.28|<0.0001
71688695|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.82|STANDARD_ERROR_OF_MEAN|0.83||0.0017|TWO_SIDED|90.0|1.41|4.23|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.75 hrs post-dose)||4.23|1.41|0.0017
71822330|NCT00577720|143146826|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.243|||||TWO_SIDED|90.0|0.828|1.99||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.990|0.828|
71822331|NCT00577720|143146827|SUPERIORITY_OR_OTHER||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|0.947|||||TWO_SIDED|90.0|0.316|2.993||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||2.993|0.316|
71822332|NCT00577720|143146827|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.82|||||TWO_SIDED|90.0|0.929|5.429||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||5.429|0.929|
71822333|NCT00577720|143146827|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.58|||||TWO_SIDED|90.0|0.801|4.718||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.718|0.801|
71822334|NCT00577720|143146827|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.668|||||TWO_SIDED|90.0|0.856|4.668||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||4.668|0.856|
71822335|NCT00577720|143146827|SUPERIORITY_OR_OTHER||Ratio (LS Mean 50 mg DRFB/50 mgDRBB)|0.868|||||TWO_SIDED|90.0|0.504|1.488||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).||1.488|0.504|
71904863|NCT00839423|143331178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.34|-0.56||A nominal p-value is provided.|ANCOVA|||||-0.56|-1.34|<0.0001
71904864|NCT00839423|143331179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.9|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.90|0.0003
71904865|NCT00839423|143331179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.92|-0.27||A nominal p-value is provided.|ANCOVA|||||-0.27|-0.92|0.0003
71822336|NCT01778062|143146914|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71822337|NCT04445155|143146935|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
71822338|NCT04445155|143146937|SUPERIORITY|||||||0.011|||||||Paired t-test|||"Null Hypothesis: The means of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The means of the scores are different at baseline and immediately post-intervention."||||0.011
71822339|NCT04445155|143146938|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
71822340|NCT04445155|143146938|SUPERIORITY|||||||0.008|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.008
71822341|NCT04445155|143146939|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
71904866|NCT00839423|143331180|SUPERIORITY_OR_OTHER||Difference %|21.9||||0.002|TWO_SIDED|95.0|8.89|34.92||A nominal p-value is provided.|Fisher Exact|||||34.92|8.89|0.002
71904867|NCT00839423|143331180|SUPERIORITY_OR_OTHER||Difference %|23.34||||0.001|TWO_SIDED|95.0|10.05|36.43||A nominal p-value is provided.|Fisher Exact|||||36.43|10.05|0.001
71904868|NCT00839423|143331181|SUPERIORITY_OR_OTHER||Difference %|22.41||||0.001|TWO_SIDED|95.0|9.74|35.07||A nominal p-value is provided.|Fisher Exact|||||35.07|9.74|0.001
71904869|NCT00839423|143331181|SUPERIORITY_OR_OTHER||Difference %|22.33||||0.001|TWO_SIDED|95.0|9.39|35.28||A nominal p-value is provided.|Fisher Exact|||||35.28|9.39|0.001
71904870|NCT00423735|143331200|SUPERIORITY|||||||0.99|||||||Fisher Exact|2-sided test||||||0.99
71904871|NCT02504268|143331207|SUPERIORITY|||||||0.2359|||||||Regression, Logistic|||||||0.2359
71904872|NCT02504268|143331208|SUPERIORITY|||||||0.0112|||||||Regression, Logistic|||||||0.0112
71680818|NCT03301740|142880189|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.2|6.0||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important chest pain between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.0|0.2|1.0
71680819|NCT03301740|142880190|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.3||||0.7|TWO_SIDED|95.0|0.3|6.5||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important shortness of breath between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.5|0.3|0.7
71680820|NCT03301740|142880191|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.2|TWO_SIDED|95.0|0.3|1.2||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important thirst/dry mouth between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||1.2|0.3|0.2
71822342|NCT04445155|143146939|SUPERIORITY|||||||0.002|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.002
71822343|NCT04445155|143146940|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||<0.001
71822344|NCT04445155|143146940|SUPERIORITY|||||||0.125|||||||Wilcoxon Signed-Rank test|||"Null Hypothesis: The distributions of the scores are the same at baseline and immediately post-intervention.~Alternative Hypothesis: The distributions of the scores are different at baseline and immediately post-intervention."||||0.125
71854469|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98||||0.292||95.0|-1.42|9.37|||ANCOVA|||||9.37|-1.42|0.292
71854470|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.95||||0.004||95.0|3.94|13.96|||ANCOVA|||||13.96|3.94|0.004
71854471|NCT00043186|143223069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.12||||0.094||95.0|0.57|11.67|||ANCOVA|||||11.67|0.57|0.094
71854472|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.93|||<|0.001||95.0|3.97|9.89|||ANCOVA|||||9.89|3.97|<0.001
71854473|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.89|||<|0.001||95.0|1.92|7.85|||ANCOVA|||||7.85|1.92|<0.001
71854474|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.15|||<|0.001||95.0|11.08|17.21|||ANCOVA|||||17.21|11.08|<0.001
71854475|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73|||<|0.001||95.0|9.94|15.52|||ANCOVA|||||15.52|9.94|<0.001
71854476|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.49|||<|0.001||95.0|9.66|15.32|||ANCOVA|||||15.32|9.66|<0.001
71854477|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.42|||<|0.001||95.0|8.12|14.73|||ANCOVA|||||14.73|8.12|<0.001
71854478|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.32|||<|0.001||95.0|9.15|15.49|||ANCOVA|||||15.49|9.15|<0.001
71854479|NCT00043186|143223070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|||<|0.001||95.0|8.72|14.76|||ANCOVA|||||14.76|8.72|<0.001
71854480|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854481|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854482|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854483|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854484|NCT00043186|143223071|SUPERIORITY_OR_OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
71854485|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854486|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854487|NCT00043186|143223071|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854488|NCT00043186|143223072|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71854489|NCT00043186|143223072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854490|NCT00043186|143223072|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71854491|NCT00043186|143223072|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71854492|NCT00043186|143223072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854493|NCT00043186|143223072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854494|NCT00043186|143223072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854495|NCT00043186|143223072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854496|NCT00043186|143223073|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854497|NCT00043186|143223073|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71854498|NCT00043186|143223073|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71854499|NCT00043186|143223073|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71854500|NCT00043186|143223073|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71680821|NCT03301740|142880192|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.9||||0.8|TWO_SIDED|95.0|0.4|2.3||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important headache between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.3|0.4|0.8
71680822|NCT03301740|142880193|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|2.8||||0.02|TWO_SIDED|95.0|1.2|6.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important itching between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||6.6|1.2|0.02
71688696|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|90.0|2.51|5.09|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.25 hrs post-dose)||5.09|2.51|<0.0001
71854501|NCT00043186|143223073|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71854502|NCT00043186|143223073|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71854503|NCT00043186|143223073|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854504|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
71854505|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
71854506|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71854507|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71854508|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71854509|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
71854510|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.050
71854511|NCT00043186|143223074|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||||||0.073
71904873|NCT02504268|143331209|SUPERIORITY|||||||0.0021|||||||Regression, Logistic|||||||0.0021
71854512|NCT00043186|143223075|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854513|NCT00043186|143223075|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854514|NCT00043186|143223075|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71854515|NCT00043186|143223075|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854516|NCT00043186|143223075|SUPERIORITY_OR_OTHER|||||||0.409|||||||Wilcoxon (Mann-Whitney)|||||||0.409
71854517|NCT00043186|143223075|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854518|NCT00043186|143223075|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71854519|NCT00043186|143223075|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71854520|NCT00043186|143223076|SUPERIORITY_OR_OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71854521|NCT00043186|143223076|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854522|NCT00043186|143223076|SUPERIORITY_OR_OTHER|||||||0.077|||||||Wilcoxon (Mann-Whitney)|||||||0.077
71854523|NCT00043186|143223076|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71854524|NCT00043186|143223076|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854525|NCT00043186|143223076|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71854526|NCT00043186|143223076|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71854527|NCT00043186|143223076|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71854528|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
71854529|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
71854530|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||||||0.022
71854531|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71854532|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
71854533|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
71854534|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71854535|NCT00043186|143223077|SUPERIORITY_OR_OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||||||0.053
71854536|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
71854537|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
71854538|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71854539|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||||||0.047
71854540|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||0.015
71854541|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
71854542|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||||||0.168
71854543|NCT00043186|143223078|SUPERIORITY_OR_OTHER|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||||||0.172
71904874|NCT02504268|143331210|SUPERIORITY||||||<|0.0001|||||||rank-based ANCOVA|||||||< 0.0001
71904875|NCT02504268|143331211|SUPERIORITY|||||||0.0006|||||||Regression, Logistic|||||||0.0006
71904876|NCT03025217|143331212|OTHER||Cohen's d|0.33||||0.095|TWO_SIDED||||||t-test, 2 sided|||||||.095
71904877|NCT03025217|143331213|OTHER||Cohen's d|0.75||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||.001
71680823|NCT03301740|142880194|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.7|TWO_SIDED|95.0|0.5|2.6||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important restless legs/difficulty keeping legs still between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.6|0.5|0.7
71680824|NCT03301740|142880195|EQUIVALENCE|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.5|TWO_SIDED|95.0|0.2|2.4||Statistically significant p-value is \<0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important tingling/feeling of pins and needles between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.||2.4|0.2|0.5
71680825|NCT01037127|142880197|SUPERIORITY_OR_OTHER||percentage of participants|25.0|||||TWO_SIDED|95.0|14.1|37.8|||||The estimated value reflects the percentage of particpants with CR and PR.|||37.8|14.1|
71680826|NCT01037127|142880198|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|2.1|48.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||48.4|2.1|
71680827|NCT01037127|142880198|SUPERIORITY_OR_OTHER||percentage of participants|27.0|||||TWO_SIDED|95.0|14.6|41.9|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.9|14.6|
71680828|NCT01037127|142880198|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|14.3|41.4|||||The estimated value reflects the percentage of particpants with CR and PR.|||41.4|14.3|
71680829|NCT01037127|142880198|SUPERIORITY_OR_OTHER||percentage of participants|28.0|||||TWO_SIDED|95.0|14.2|45.2|||||The estimated value reflects the percentage of particpants with CR and PR.|||45.2|14.2|
71680830|NCT01037127|142880199|SUPERIORITY_OR_OTHER||percentage of participants|20.0||||||95.0|7.7|38.6|||||The estimated value reflects the percentage of particpants with CR and PR.|||38.6|7.7|
71854544|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.67|||<|0.001||95.0|1.7|3.64|||ANCOVA|||||3.64|1.70|<0.001
71854545|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.001||95.0|1.9|3.89|||ANCOVA|||||3.89|1.90|<0.001
71854546|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.09|||<|0.001||95.0|2.07|4.11|||ANCOVA|||||4.11|2.07|<0.001
71904878|NCT00194025|143331214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
71680831|NCT02584998|142880211|OTHER||||||<|0.001|||||||Chi-squared|||In our power and sample size analysis, we assumed 15% screening rate in usual care, 25% with invitation, and 40% with mailed-FIT. A sample size of 500 (250/arm) will give 80% power for UC vs. screening invitation-reminder, and 152/arm will give a power of 80% for the screening invitation-reminder vs. mailed-FIT. Accounting for the possibility that up to 20% of participants could be ineligible post-randomization, we concluded that we should enroll 783 patients, 261 per arm, for this trial.||||<0.001
71680832|NCT02847182|142880229|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.83|TWO_SIDED|95.0|-1.58|3.86|||t-test, 2 sided|||Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.||3.86|-1.58|0.83
71904879|NCT00194025|143331215|SUPERIORITY_OR_OTHER|||||||0.585||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.585
71680833|NCT00962091|142880295|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.9|||||TWO_SIDED|90.0|1.52|2.37|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||2.37|1.52|
71680834|NCT00962091|142880296|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.08|1.78|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=OS-PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.78|1.08|
71854547|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12|||<|0.001||95.0|3.13|5.11|||ANCOVA|||||5.11|3.13|<0.001
71854548|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||<|0.001||95.0|1.55|3.46|||ANCOVA|||||3.46|1.55|<0.001
71854549|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||<|0.001||95.0|2.83|4.95|||ANCOVA|||||4.95|2.83|<0.001
71854550|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|||<|0.001||95.0|1.99|4.04|||ANCOVA|||||4.04|1.99|<0.001
71854551|NCT00043186|143223079|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.46|||<|0.001||95.0|2.43|4.48|||ANCOVA|||||4.48|2.43|<0.001
71854552|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19|||<|0.001||95.0|4.04|6.34|||ANCOVA|||||6.34|4.04|<0.001
71854553|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|||<|0.001||95.0|4.93|7.27|||ANCOVA|||||7.27|4.93|<0.001
71854554|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59|||<|0.001||95.0|4.4|6.78|||ANCOVA|||||6.78|4.40|<0.001
71854555|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.89|||<|0.001||95.0|5.76|8.01|||ANCOVA|||||8.01|5.76|<0.001
71854556|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|||<|0.001||95.0|3.41|5.67|||ANCOVA|||||5.67|3.41|<0.001
71904880|NCT00194025|143331216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||<0.001
71904881|NCT00194025|143331217|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.017
71904882|NCT00194025|143331218|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.027
71904883|NCT00194025|143331219|SUPERIORITY_OR_OTHER|||||||0.569||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.569
71904884|NCT00194025|143331220|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.038
71680835|NCT00962091|142880302|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.66|1.06|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.06|0.66|
71854557|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.95|||<|0.001||95.0|5.69|8.21|||ANCOVA|||||8.21|5.69|<0.001
71854558|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|||<|0.001||95.0|4.29|6.67|||ANCOVA|||||6.67|4.29|<0.001
71854559|NCT00043186|143223080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|4.76|7.17|||ANCOVA|||||7.17|4.76|<0.001
71854560|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.78|||<|0.001||95.0|2.19|5.36|||ANCOVA|||||5.36|2.19|<0.001
71854561|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.41||||0.07||95.0|-0.12|2.94|||ANCOVA|||||2.94|-0.12|0.07
71854562|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.17|||<|0.001||95.0|5.54|8.8|||ANCOVA|||||8.80|5.54|<0.001
71854563|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.67|||<|0.001||95.0|7.13|10.21|||ANCOVA|||||10.21|7.13|<0.001
71854564|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.15|||<|0.001||95.0|5.62|8.69|||ANCOVA|||||8.69|5.62|<0.001
71854565|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.07||95.0|-0.12|3.35|||ANCOVA|||||3.35|-0.12|0.07
71854566|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.26|||<|0.001||95.0|5.56|8.95|||ANCOVA|||||8.95|5.56|<0.001
71854567|NCT00043186|143223081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.63|||<|0.001||95.0|6.02|9.24|||ANCOVA|||||9.24|6.02|<0.001
71854568|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.94||||0.002||95.0|1.86|8.02|||ANCOVA|||||8.02|1.86|0.002
71854569|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.677||95.0|-4.1|2.68|||ANCOVA|||||2.68|-4.10|0.677
71854570|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.66||||0.001||95.0|3.14|10.18|||ANCOVA|||||10.18|3.14|0.001
71854571|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.29|||<|0.001||95.0|5.26|11.33|||ANCOVA|||||11.33|5.26|<0.001
71854572|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||<|0.001||95.0|3.59|9.41|||ANCOVA|||||9.41|3.59|<0.001
71854573|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||0.047||95.0|0.61|8.05|||ANCOVA|||||8.05|0.61|0.047
71854574|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.94||||0.003||95.0|2.53|9.36|||ANCOVA|||||9.36|2.53|0.003
71854575|NCT00043186|143223082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.97||||0.001||95.0|3.28|10.66|||ANCOVA|||||10.66|3.28|0.001
71854576|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.69|||<|0.001||95.0|2.97|6.41|||ANCOVA|||||6.41|2.97|<0.001
71854577|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.16||||0.015||95.0|0.43|3.89|||ANCOVA|||||3.89|0.43|0.015
71854578|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.52|||<|0.001||95.0|6.74|10.3|||ANCOVA|||||10.30|6.74|<0.001
71854579|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.58|||<|0.001||95.0|7.95|11.21|||ANCOVA|||||11.21|7.95|<0.001
71854580|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.34|||<|0.001||95.0|6.7|9.99|||ANCOVA|||||9.99|6.70|<0.001
71854581|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.38|||<|0.001||95.0|5.45|9.31|||ANCOVA|||||9.31|5.45|<0.001
71854582|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.55|||<|0.001||95.0|5.72|9.38|||ANCOVA|||||9.38|5.72|<0.001
71854583|NCT00043186|143223083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.97|||<|0.001||95.0|7.23|10.72|||ANCOVA|||||10.72|7.23|<0.001
71854584|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44||||0.033||95.0|0.11|2.76|||ANCOVA|||||2.76|0.11|0.033
71854585|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|||<|0.001||95.0|1.69|4.42|||ANCOVA|||||4.42|1.69|<0.001
71854586|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.04|||<|0.001||95.0|1.68|4.4|||ANCOVA|||||4.40|1.68|<0.001
71854587|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|||<|0.001||95.0|1.94|4.57|||ANCOVA|||||4.57|1.94|<0.001
71854588|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.91|||<|0.001||95.0|1.6|4.21|||ANCOVA|||||4.21|1.60|<0.001
71854589|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07|||<|0.001||95.0|1.65|4.49|||ANCOVA|||||4.49|1.65|<0.001
71854590|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37|||<|0.001||95.0|0.99|3.76|||ANCOVA|||||3.76|0.99|<0.001
71854591|NCT00043186|143223084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|||<|0.001||95.0|1.47|4.24|||ANCOVA|||||4.24|1.47|<0.001
71854592|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.99||||0.009||95.0|0.49|3.49|||ANCOVA|||||3.49|0.49|0.009
71854593|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.58|||<|0.001||95.0|2.06|5.1|||ANCOVA|||||5.10|2.06|<0.001
71854594|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|||<|0.001||95.0|2.73|5.78|||ANCOVA|||||5.78|2.73|<0.001
71904885|NCT00194025|143331221|SUPERIORITY_OR_OTHER|||||||0.199||95.0|||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.||||0.199
71904886|NCT00194025|143331222|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||The t-test was applied to the values at baseline vs. the values at 12 weeks.||||0.21
71854595|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|||<|0.001||95.0|2.55|5.62|||ANCOVA|||||5.62|2.55|<0.001
71854596|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||<|0.001||95.0|3.23|6.11|||ANCOVA|||||6.11|3.23|<0.001
71854597|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.26|||<|0.001||95.0|3.78|6.73|||ANCOVA|||||6.73|3.78|<0.001
71854598|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.08|||<|0.001||95.0|2.48|5.68|||ANCOVA|||||5.68|2.48|<0.001
71854599|NCT00043186|143223085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39|||<|0.001||95.0|1.86|4.93|||ANCOVA|||||4.93|1.86|<0.001
71854600|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.69||||0.002||95.0|1.01|4.38|||ANCOVA|||||4.38|1.01|0.002
71854601|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.77|||<|0.001||95.0|2.14|5.39|||ANCOVA|||||5.39|2.14|<0.001
71854602|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||<|0.001||95.0|3.87|7.26|||ANCOVA|||||7.26|3.87|<0.001
71854603|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|||<|0.001||95.0|4.75|7.92|||ANCOVA|||||7.92|4.75|<0.001
71854604|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.73|||<|0.001||95.0|4.12|7.33|||ANCOVA|||||7.33|4.12|<0.001
71854605|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.89|6.5|||ANCOVA|||||6.50|2.89|<0.001
71854606|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.92|6.49|||ANCOVA|||||6.49|2.92|<0.001
71854607|NCT00043186|143223086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|||<|0.001||95.0|3.96|7.3|||ANCOVA|||||7.30|3.96|<0.001
71854608|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27||||0.496||95.0|-7.16|13.7|||ANCOVA|||||13.7|-7.16|0.496
71854609|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6||||0.527||95.0|-6.38|19.59|||ANCOVA|||||19.59|-6.38|0.527
71854610|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72||||0.503||95.0|-2.9|14.33|||ANCOVA|||||14.33|-2.90|0.503
71854611|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.68||||0.527||95.0|-6.54|11.89|||ANCOVA|||||11.89|-6.54|0.527
71854612|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41||||0.503||95.0|-2.19|17.01|||ANCOVA|||||17.01|-2.19|0.503
71854613|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.59||||0.503||95.0|-1.85|17.03|||ANCOVA|||||17.03|-1.85|0.503
71854614|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.18||||0.503||95.0|-2.45|16.81|||ANCOVA|||||16.81|-2.45|0.503
71854615|NCT00043186|143223087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.233||95.0|0.78|14.97|||ANCOVA|||||14.97|0.78|0.233
71854616|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.41|||<|0.001||95.0|4.48|8.34|||ANCOVA|||||8.34|4.48|<0.001
71854617|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44|||<|0.001||95.0|4.19|8.7|||ANCOVA|||||8.70|4.19|<0.001
71854618|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|3.91|8.26|||ANCOVA|||||8.26|3.91|<0.001
71854619|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|||<|0.001||95.0|3.7|7.73|||ANCOVA|||||7.73|3.70|<0.001
71854620|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.054||95.0|-0.04|4.04|||ANCOVA|||||4.04|-0.04|0.054
71854621|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.71|5.77|||ANCOVA|||||5.77|1.71|<0.001
71854622|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.05|||<|0.001||95.0|4.0|8.1|||ANCOVA|||||8.10|4.00|<0.001
71854623|NCT00043186|143223088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.39|||<|0.001||95.0|4.49|8.28|||ANCOVA|||||8.28|4.49|<0.001
71854624|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.001||95.0|1.09|3.51|||ANCOVA|||||3.51|1.09|0.001
71854625|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.73||||0.005||95.0|0.52|2.93|||ANCOVA|||||2.93|0.52|0.005
71854626|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.004||95.0|0.74|3.25|||ANCOVA|||||3.25|0.74|0.004
71854627|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|||<|0.001||95.0|1.54|3.91|||ANCOVA|||||3.91|1.54|<0.001
71854628|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77||||0.202||95.0|-0.41|1.95|||ANCOVA|||||1.95|-0.41|0.202
71854629|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.95|||<|0.001||95.0|1.65|4.26|||ANCOVA|||||4.26|1.65|<0.001
71854630|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.02||||0.004||95.0|0.78|3.26|||ANCOVA|||||3.26|0.78|0.004
71854631|NCT00043186|143223089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.004||95.0|0.8|3.27|||ANCOVA|||||3.27|0.80|0.004
71854632|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.14|||<|0.001||95.0|1.71|4.56|||ANCOVA|||||4.56|1.71|<0.001
71854633|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|||<|0.001||95.0|2.95|5.84|||ANCOVA|||||5.84|2.95|<0.001
71854634|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.64|||<|0.001||95.0|3.19|6.09|||ANCOVA|||||6.09|3.19|<0.001
71854635|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.22|||<|0.001||95.0|2.85|5.58|||ANCOVA|||||5.58|2.85|<0.001
71854636|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.53|||<|0.001||95.0|1.13|3.94|||ANCOVA|||||3.94|1.13|<0.001
71854637|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.09|||<|0.001||95.0|4.53|7.64|||ANCOVA|||||7.64|4.53|<0.001
71854638|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.55|||<|0.001||95.0|3.12|5.98|||ANCOVA|||||5.98|3.12|<0.001
71854639|NCT00043186|143223090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|||<|0.001||95.0|2.76|5.69|||ANCOVA|||||5.69|2.76|<0.001
71854640|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|||<|0.001||95.0|3.63|8.68|||ANCOVA|||||8.68|3.63|<0.001
71854641|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32||||0.275||95.0|-1.06|3.7|||ANCOVA|||||3.7|-1.06|0.275
71854642|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.005||95.0|1.65|6.75|||ANCOVA|||||6.75|1.65|0.005
71854643|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.41||||0.002||95.0|2.07|6.75|||ANCOVA|||||6.75|2.07|0.002
71854644|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.65||||0.009||95.0|1.25|6.05|||ANCOVA|||||6.05|1.25|0.009
71854645|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95||||0.009||95.0|1.22|6.68|||ANCOVA|||||6.68|1.22|0.009
71854646|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.003||95.0|2.05|7.24|||ANCOVA|||||7.24|2.05|0.003
71854647|NCT00043186|143223091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.001||95.0|2.28|7.22|||ANCOVA|||||7.22|2.28|0.001
71854648|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.18||||0.949||95.0|-8.73|13.1|||ANCOVA|||||13.10|-8.73|0.949
71854649|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.949||95.0|-2.7|9.31|||ANCOVA|||||9.31|-2.70|0.949
71854650|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24||||0.709||95.0|-6.81|9.29|||ANCOVA|||||9.29|-6.81|0.709
71854651|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.949||95.0|-8.55|3.83|||ANCOVA|||||3.83|-8.55|0.949
71904887|NCT04804033|143331226|OTHER||Difference in least square mean (LSM)|-1.4|||||TWO_SIDED|97.5|-2.72|-0.12|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.12|-2.72|
71854652|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.949||95.0|-4.51|8.72|||ANCOVA|||||8.72|-4.51|0.949
71904888|NCT04804033|143331226|OTHER||Difference in LSM|-0.7|||||TWO_SIDED|97.5|-2.07|0.69|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.69|-2.07|
71904889|NCT04804033|143331227|OTHER||Difference in percentage|16.6|||||TWO_SIDED|97.5|4.4|28.8|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||28.8|4.4|
71854653|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.23||||0.484||95.0|-0.83|15.3|||ANCOVA|||||15.3|-0.83|0.484
71854654|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.949||95.0|-3.77|8.66|||ANCOVA|||||8.66|-3.77|0.949
71854655|NCT00043186|143223092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.949||95.0|-10.82|11.4|||ANCOVA|||||11.40|-10.82|0.949
71854656|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.02|||<|0.001||95.0|4.35|9.69|||ANCOVA|||||9.69|4.35|<0.001
71854657|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.25||||0.092||95.0|-0.37|4.87|||ANCOVA|||||4.87|-0.37|0.092
71854658|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.5|8.94|||ANCOVA|||||8.94|3.50|<0.001
71854659|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.97|||<|0.001||95.0|3.51|8.43|||ANCOVA|||||8.43|3.51|<0.001
71854660|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.96|||<|0.001||95.0|3.44|8.48|||ANCOVA|||||8.48|3.44|<0.001
71854661|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.29|||<|0.001||95.0|3.25|9.34|||ANCOVA|||||9.34|3.25|<0.001
71854662|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001||95.0|3.13|8.7|||ANCOVA|||||8.70|3.13|<0.001
71854663|NCT00043186|143223093|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.58|8.87|||ANCOVA|||||8.87|3.58|<0.001
71854664|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854665|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854666|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854667|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854668|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854669|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854670|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854671|NCT00043186|143223094|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854672|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854673|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854674|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854675|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854676|NCT00043186|143223095|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71854677|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854678|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854679|NCT00043186|143223095|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854680|NCT00043186|143223096|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71854681|NCT00043186|143223096|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71854682|NCT00043186|143223096|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854683|NCT00043186|143223096|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854684|NCT00043186|143223096|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854685|NCT00043186|143223096|SUPERIORITY_OR_OTHER|||||||0.146|||||||Wilcoxon (Mann-Whitney)|||||||0.146
71904890|NCT04804033|143331227|OTHER||Difference in percentage|6.6|||||TWO_SIDED|97.5|-5.6|18.9|||||Stratified by randomization stratum using Mantel-Haenszel risk estimation.|||18.9|-5.6|
71854686|NCT00043186|143223096|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71854687|NCT00043186|143223096|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854688|NCT00043186|143223097|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||||||0.061
71854689|NCT00043186|143223097|SUPERIORITY_OR_OTHER|||||||0.058|||||||Wilcoxon (Mann-Whitney)|||||||0.058
71854690|NCT00043186|143223097|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71854691|NCT00043186|143223097|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854692|NCT00043186|143223097|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854693|NCT00043186|143223097|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71854694|NCT00043186|143223097|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71904891|NCT04804033|143331228|OTHER||Difference in LSM|-1.0|||||TWO_SIDED|97.5|-2.68|0.58|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.58|-2.68|
71904892|NCT04804033|143331228|OTHER||Difference in LSM|-0.4|||||TWO_SIDED|97.5|-2.1|1.31|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||1.31|-2.10|
71854695|NCT00043186|143223097|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71854696|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
71854697|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.218|||||||Wilcoxon (Mann-Whitney)|||||||0.218
71854698|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71854699|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
71854700|NCT00043186|143223098|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71854701|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.010
71854702|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71854703|NCT00043186|143223098|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71854704|NCT05012280|143223104|SUPERIORITY||Odds Ratio (OR)|1.221||||0.115|TWO_SIDED|95.0|0.953|1.564||only one primary endpoint, p value not adjusted for multiple comparisons. A priori treshold or statistical significance: p=0.05|Regression, Logistic|conditional logistic regression for matched case control||||1.564|0.953|0.1150
71854705|NCT05012280|143223104|SUPERIORITY||Odds Ratio (OR)|1.221||||0.12|TWO_SIDED|95.0|0.953|1.564|||Regression, Logistic|conditional logistic regression for matched case control study.||||1.564|0.953|0.12
71854706|NCT03245762|143223110|SUPERIORITY||Odds Ratio (OR)|0.9||||0.93|TWO_SIDED||||||Ordinal Categorical Analysis|||||||0.930
71854707|NCT00382408|143223144|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|99.31|||||TWO_SIDED|95.0|96.02|99.88||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.88|96.02|
71854708|NCT00382408|143223149|SUPERIORITY_OR_OTHER||vaccine efficacy (VE)|98.46|||||TWO_SIDED|95.0|95.39|99.49||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.||99.49|95.39|
71854709|NCT03209050|143223160|OTHER|||||||0.5|||||||Clopper-Pearson 95% CI|||||||0.5
71854710|NCT00139659|143223165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.08|0.011|||longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||0.011|-0.080|
71854711|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.065|0.015|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.015|-0.065|
71854712|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.073|0.006|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.006|-0.073|
71854713|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.016|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.016|-0.063|
71854714|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.035|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.075|0.004|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.075|
71854715|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.067|0.012|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.012|-0.067|
71854716|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.073|0.008|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.008|-0.073|
71854717|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.059|0.023|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.059|
71854718|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.052|0.031|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.031|-0.052|
71854719|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.068|0.017|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.068|
71854720|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.117|-0.029|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.029|-0.117|
71854721|NCT00139659|143223166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.108|-0.015|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.015|-0.108|
71854722|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.214||||90.0|-0.679|0.026|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.679|
71854723|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.378|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.729|-0.027|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.027|-0.729|
71854724|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.696|0.004|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.004|-0.696|
71854725|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.496|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.847|-0.145|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.145|-0.847|
71854726|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.213||||90.0|-0.96|-0.26|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.260|-0.960|
71854727|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-0.721|0.001|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.001|-0.721|
71854728|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.291|STANDARD_ERROR_OF_MEAN|0.221||||90.0|-0.655|0.073|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.073|-0.655|
71854729|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.224||||90.0|-0.788|-0.052|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.052|-0.788|
71854730|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.337|STANDARD_ERROR_OF_MEAN|0.231||||90.0|-0.717|0.042|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.042|-0.717|
71854731|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.789|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.181|-0.397|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.397|-1.181|
71680836|NCT00962091|142880303|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.8|1.34|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.34|0.80|
71680837|NCT00962091|142880304|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.94|||||TWO_SIDED|90.0|0.68|1.32|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUC values (difference=Fed-Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.|||1.32|0.68|
71680838|NCT04216589|142880323|OTHER|This was a single arm trial.|Mean Difference (Net)|-4.24|STANDARD_DEVIATION|4.05|<|0.001|TWO_SIDED|95.0|-5.41|-3.06|||Regression, Linear|||The study was powered to detect an absolute IHTG change of -5% assuming a null change of 0%, a standard deviation of absolute IHTG change of 9%, and 37 evaluable participants.||-3.06|-5.41|<0.001
71680839|NCT04216589|142880324|OTHER|This was a single arm trial.|Mean Difference (Net)|-31.33|STANDARD_DEVIATION|26.5|<|0.001|TWO_SIDED|95.0|-39.04|-23.62||No adjustment for multiple comparisons|Regression, Linear|||||-23.62|-39.04|<0.001
71854732|NCT00139659|143223167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.238||||90.0|-1.178|-0.393|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.393|-1.178|
71904893|NCT04804033|143331229|OTHER||Difference in LSM|-1.8|||||TWO_SIDED|97.5|-3.16|-0.42|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||-0.42|-3.16|
71904894|NCT04804033|143331229|OTHER||Difference in LSM|-1.2|||||TWO_SIDED|97.5|-2.53|0.22|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.22|-2.53|
71680840|NCT04216589|142880328|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.77|STANDARD_DEVIATION|2.05|<|0.001|TWO_SIDED|95.0|-3.36|-2.17||Not adjusted for multiple comparisons.|Regression, Linear|||||-2.17|-3.36|<0.001
71680841|NCT04216589|142880329|OTHER|This was a single arm trial.|Mean Difference (Net)|-2.15|STANDARD_DEVIATION|1.38|<|0.001|TWO_SIDED|95.0|-2.55|-1.75||Not adjusted for multiple comparisons|Regression, Linear|||||-1.75|-2.55|<0.001
71680842|NCT04216589|142880330|OTHER|This was a single arm trial.|Mean Difference (Net)|-7.8|STANDARD_DEVIATION|5.77|<|0.001|TWO_SIDED|95.0|-9.48|-6.13||Not adjusted for multiple comparisons|Regression, Linear|||||-6.13|-9.48|<0.001
71680843|NCT04216589|142880331|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.16|STANDARD_DEVIATION|3.96|<|0.001|TWO_SIDED|95.0|-7.3|-5.03||Not adjusted for multiple comparisons|Regression, Linear|||||-5.03|-7.30|<0.001
71680844|NCT04216589|142880332|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.66|STANDARD_DEVIATION|6.47|<|0.001|TWO_SIDED|95.0|-8.54|-4.78||Not adjusted for multiple comparisons|Regression, Linear|||||-4.78|-8.54|<0.001
71854733|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.066|0.023|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.023|-0.066|
71854734|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.044|0.044|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.044|-0.044|
71854735|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.056|0.032|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.032|-0.056|
71854736|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.048|0.041|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.048|
71854737|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.089|-0.001|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.001|-0.089|
71854738|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.035|0.056|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.056|-0.035|
71854739|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.028|0.064|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.064|-0.028|
71904895|NCT04804033|143331230|OTHER||Difference in LSM|-0.8|||||TWO_SIDED|97.5|-1.59|0.05|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.05|-1.59|
71904896|NCT04804033|143331230|OTHER||Difference in LSM|-0.2|||||TWO_SIDED|97.5|-1.06|0.74|||||Linear mixed effects model with repeated measures with number of total migraine days per month in the OP as covariate, treatment group, randomization stratum, month, month-by treatment group interaction as fixed effects using migraine analysis set.|||0.74|-1.06|
71904897|NCT04804033|143331231|OTHER||Difference in LSM|3.9|||||TWO_SIDED|97.5|-1.5|9.39|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||9.39|-1.50|
71904898|NCT04804033|143331231|OTHER||Difference in LSM|0.1|||||TWO_SIDED|97.5|-5.66|5.86|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||5.86|-5.66|
71904899|NCT04804033|143331232|OTHER||Difference in LSM|-9.0|||||TWO_SIDED|97.5|-18.1|0.19|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.19|-18.10|
71904900|NCT04804033|143331232|OTHER||Difference in LSM|-9.3|||||TWO_SIDED|97.5|-18.95|0.41|||||Linear regression model had the following variables: Week 12 change from baseline in domain score as the dependent variable; baseline domain score as a covariate; treatment group and randomization stratum as fixed effects.|||0.41|-18.95|
71904901|NCT02108600|143331248|OTHER|||||||0.033|TWO_SIDED|95.0|||||Fisher Exact|||||||0.033
71904902|NCT01580592|143331311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.6|STANDARD_DEVIATION|7.6||0.001|TWO_SIDED||||||ANOVA||for omalizumab 150mg|||||0.001
71904903|NCT01580592|143331311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_DEVIATION|9.4||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71904904|NCT01580592|143331311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.9|||TWO_SIDED|||||||||||||
71904905|NCT01580592|143331312|SUPERIORITY_OR_OTHER|||||||0.988|||||||Chi-squared|||||||0.988
71904906|NCT03471767|143331319|SUPERIORITY|Multilevel modeling (MLM) was used to model daily reports of cigarettes smoked as a function of week, treatment (AXS-05 vs. bupropion), and the interaction between week and treatment. The contrast between the two treatment groups in change in smoking intensity from baseline to week 3 was estimated within the context of the model.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.54||0.05|TWO_SIDED|95.0|-2.75|-0.65||This was not adjusted for multiple comparisons, because the primary hypothesis was established a-priori.|t-test, 2 sided|||||-0.65|-2.75|0.05
71904907|NCT03471767|143331325|OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
71904908|NCT00678587|143331326|SUPERIORITY_OR_OTHER||Absolute difference in proportions|52.8|||<|0.0001|TWO_SIDED|95.0|43.2|62.4|||Cochran-Mantel-Haenszel|||||62.4|43.2|<0.0001
71904909|NCT00678587|143331327|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-5.9|||||TWO_SIDED|95.0|-15.1|3.3||||||||3.3|-15.1|
71904910|NCT00678587|143331328|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71904911|NCT00305253|143331360|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.019|TWO_SIDED|95.0|0.17|0.85|||Regression, Logistic|Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).|Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|"Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used."||0.85|0.17|0.019
71904912|NCT00305253|143331361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.79|||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Mean measured volume of blood loss in the drape was compared across phases with t-tests.||||<0.0001
71904913|NCT00305253|143331362|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.41|||<|0.05|TWO_SIDED|95.0|0.21|0.8|||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Relative risks and confidence intervals were computed for emergency hysterectomy.||0.80|0.21|<0.05
71904914|NCT05373706|143331369|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.95||||0.68|TWO_SIDED|95.0|0.76|1.2|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.20|0.76|0.68
71904915|NCT05373706|143331369|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.1||||0.56|TWO_SIDED|95.0|0.81|1.49|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.49|0.81|0.56
71921923|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-6.1|STANDARD_ERROR_OF_MEAN|7.3|||TWO_SIDED|95.0|-21.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14 predose AM||9.0|-21.1|
71904916|NCT05373706|143331370|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.93||||0.68|TWO_SIDED|95.0|0.64|1.33|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.33|0.64|0.68
71904917|NCT05373706|143331370|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.24||||0.3|TWO_SIDED|95.0|0.82|1.88|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.88|0.82|0.30
71904918|NCT05373706|143331371|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.89||||0.36|TWO_SIDED|95.0|0.69|1.15|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.15|0.69|0.36
71854740|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.051|0.041|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.041|-0.051|
71904919|NCT05373706|143331371|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|1.05||||0.73|TWO_SIDED|95.0|0.8|1.38|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.38|0.80|0.73
71904920|NCT05373706|143331372|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 2-Week Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 2-Week Follow-Up.|Count/Rate Ratio|0.83||||0.11|TWO_SIDED|95.0|0.66|1.04|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.||1.04|0.66|0.11
71904921|NCT05373706|143331372|SUPERIORITY|Generalized linear mixed model was estimated using a sample of N=99 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up.|Count/Rate Ratio|0.88||||0.38|TWO_SIDED|95.0|0.66|1.17|||Generalized linear mixed model|Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution.||Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.||1.17|0.66|0.38
71854741|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.022|STANDARD_ERROR_OF_MEAN|0.029||||90.0|-0.07|0.026|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.026|-0.070|
71854742|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.03||||90.0|-0.064|0.034|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.034|-0.064|
71854743|NCT00139659|143223170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.031||||90.0|-0.067|0.037|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.037|-0.067|
71854744|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.632|STANDARD_ERROR_OF_MEAN|0.697||||90.0|-1.778|0.514|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.514|-1.778|
71854745|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.668||||90.0|-1.079|1.12|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.120|-1.079|
71854746|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.582|STANDARD_ERROR_OF_MEAN|0.679||||90.0|-0.535|1.7|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.700|-0.535|
71854747|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.687||||90.0|-1.184|1.077|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.077|-1.184|
71680845|NCT04216589|142880333|OTHER|This was a single arm trial.|Mean Difference (Net)|-5.53|STANDARD_DEVIATION|5.3|<|0.001|TWO_SIDED|95.0|-7.07|-3.99||Not adjusted for multiple comparisons|Regression, Linear|||||-3.99|-7.07|<0.001
71680846|NCT04216589|142880334|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.46|STANDARD_DEVIATION|5.82||0.092|TWO_SIDED|95.0|-3.17|0.25||Not adjusted for multiple comparisons|Regression, Linear|||||0.25|-3.17|0.092
71904922|NCT01606761|143331389|SUPERIORITY_OR_OTHER||Percentage Difference|15.9|||<|0.001|TWO_SIDED|95.0|8.5|23.2|||Cochran-Mantel-Haenszel|||||23.2|8.5|< 0.001
71904923|NCT01606761|143331389|SUPERIORITY_OR_OTHER||Percentage Difference|21.0|||<|0.001|TWO_SIDED|95.0|13.6|28.5|||Cochran-Mantel-Haenszel|||||28.5|13.6|< 0.001
71904924|NCT01606761|143331390|SUPERIORITY_OR_OTHER||Least Square (LS) mean difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.251|-0.088|||ANCOVA|||||-0.088|-0.251|< 0.001
71904925|NCT01606761|143331390|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.194|||<|0.001|TWO_SIDED|95.0|-0.275|-0.112|||ANCOVA|||||-0.112|-0.275|< 0.001
71904926|NCT01606761|143331391|SUPERIORITY_OR_OTHER||Percentage Difference|12.0|||<|0.001|TWO_SIDED|95.0|6.4|17.7|||Cochran-Mantel-Haenszel|||||17.7|6.4|< 0.001
71904927|NCT01606761|143331391|SUPERIORITY_OR_OTHER||Percentage Difference|12.7|||<|0.001|TWO_SIDED|95.0|7.0|18.4|||Cochran-Mantel-Haenszel|||||18.4|7.0|< 0.001
71854748|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.535|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.677|0.608|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.608|-1.677|
71904928|NCT01606761|143331392|SUPERIORITY_OR_OTHER||Percentage Difference|11.0|||<|0.001|TWO_SIDED|95.0|5.5|16.5|||Cochran-Mantel-Haenszel|||||16.5|5.5|< 0.001
71904929|NCT01606761|143331392|SUPERIORITY_OR_OTHER||Percentage Difference|13.4|||<|0.001|TWO_SIDED|95.0|7.8|19.1|||Cochran-Mantel-Haenszel|||||19.1|7.8|< 0.001
71904930|NCT05086289|143331393|SUPERIORITY||Posterior Mean Difference|-0.38|||||TWO_SIDED|95.0|-0.89|0.13|||||Posterior mean difference with 95% credible interval is reported.|||0.13|-0.89|
71904931|NCT05086289|143331394|SUPERIORITY||Posterior Mean Difference|-0.28|||||TWO_SIDED|95.0|-0.85|0.3|||||Posterior mean difference with 95% credible interval is reported.|||0.30|-0.85|
71680847|NCT04216589|142880336|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.25|STANDARD_DEVIATION|0.259|<|0.001|TWO_SIDED|95.0|-0.32|-0.17||Not adjusted for multiple comparisons|Regression, Linear|||||-0.17|-0.32|< 0.001
71680848|NCT04216589|142880337|OTHER|This was a single arm trial.|Mean Difference (Net)|-9.9|STANDARD_DEVIATION|16.6|<|0.001|TWO_SIDED|95.0|-14.7|-5.09||Not adjusted for multiple comparisons|Regression, Linear|||||-5.09|-14.70|<0.001
71854749|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.905|STANDARD_ERROR_OF_MEAN|0.674||||90.0|-2.014|0.203|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.203|-2.014|
71854750|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.212|STANDARD_ERROR_OF_MEAN|0.675||||90.0|-0.899|1.323|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.323|-0.899|
71854751|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.683||||90.0|-1.08|1.169|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||1.169|-1.080|
71904932|NCT05086289|143331395|SUPERIORITY||Posterior Mean Difference|-0.62|||||TWO_SIDED|95.0|-1.91|0.68|||||Posterior mean difference with 95% credible interval is reported.|||0.68|-1.91|
71904933|NCT05086289|143331396|SUPERIORITY||Posterior Mean Difference|-1.17|||||TWO_SIDED|95.0|-2.54|0.18|||||Posterior mean difference with 95% credible interval is reported.|||0.18|-2.54|
71904934|NCT05086289|143331397|SUPERIORITY||Posterior Mean Difference|-0.12|||||TWO_SIDED|95.0|-0.44|0.19|||||Posterior mean difference with 95% credible interval is reported.|||0.19|-0.44|
71904935|NCT05086289|143331398|SUPERIORITY||Posterior Mean Difference|-0.26|||||TWO_SIDED|95.0|-0.67|0.14|||||Posterior mean difference with 95% credible interval is reported.|||0.14|-0.67|
71904936|NCT05086289|143331399|SUPERIORITY||Posterior Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.05|0.09|||||Posterior mean difference with 95% credible interval is reported.|||0.09|-1.05|
71904937|NCT05086289|143331400|SUPERIORITY||Posterior Mean Difference|-0.51|||||TWO_SIDED|95.0|-1.17|0.16|||||Posterior mean difference with 95% credible interval is reported.|||0.16|-1.17|
71904938|NCT05086289|143331401|SUPERIORITY||Posterior Mean Difference|-4.95|||||TWO_SIDED|95.0|-11.07|1.27|||||Posterior mean difference with 95% credible interval is reported.|||1.27|-11.07|
71904939|NCT05086289|143331402|SUPERIORITY||Posterior Mean Difference|-4.78|||||TWO_SIDED|95.0|-11.73|2.15|||||Posterior mean difference with 95% credible interval is reported.|||2.15|-11.73|
71904940|NCT05086289|143331403|SUPERIORITY||Posterior Mean Difference|-0.13|||||TWO_SIDED|95.0|-0.46|0.21|||||Posterior mean difference with 95% credible interval is reported.|||0.21|-0.46|
71904941|NCT05086289|143331404|SUPERIORITY||Posterior Mean Difference|1.52|||||TWO_SIDED|95.0|-6.2|9.2|||||Posterior mean difference with 95% credible interval is reported.|||9.20|-6.20|
71904942|NCT05086289|143331405|SUPERIORITY||Posterior Mean Difference|0.0|||||TWO_SIDED|95.0|-0.06|0.07|||||Posterior mean difference with 95% credible interval is reported.|||0.07|-0.06|
71904943|NCT05086289|143331406|SUPERIORITY||Posterior Mean Difference|0.02|||||TWO_SIDED|95.0|-0.05|0.1|||||Posterior mean difference with 95% credible interval is reported.|||0.10|-0.05|
71904944|NCT05086289|143331407|SUPERIORITY||Posterior Mean Difference|41.72|||||TWO_SIDED|95.0|-95.92|179.76|||||Posterior mean difference with 95% credible interval is reported.|||179.76|-95.92|
71680849|NCT04216589|142880338|OTHER|This was a single arm trial.|Mean Difference (Net)|-8.87|STANDARD_DEVIATION|11.5|<|0.001|TWO_SIDED|95.0|-12.26|-5.48||Not adjusted for multiple comparisons|Regression, Linear|||||-5.48|-12.26|<0.001
71680850|NCT04216589|142880339|OTHER|This was a single arm trial.|Mean Difference (Net)|-3.98|STANDARD_DEVIATION|23.1||0.25|TWO_SIDED|95.0|-10.84|2.89||Not adjusted for multiple comparisons|Regression, Linear|||||2.89|-10.84|0.25
71854752|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.694||||90.0|-1.382|0.902|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.902|-1.382|
71854753|NCT00139659|143223171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.711||||90.0|-1.673|0.668|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.668|-1.673|
71854754|NCT00139659|143223185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.503|STANDARD_ERROR_OF_MEAN|0.216||||90.0|-0.858|-0.148|||Longitudinal data analysis model|Confidence interval of least squares (LS) mean difference (INH - SC) between annual rates of change for the two treatment groups.|Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.||-0.148|-0.858|
71854755|NCT00139659|143223189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.1||||90.0|-0.06|0.28|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.28|-0.06|
71854756|NCT00139659|143223189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.1||||90.0|0.04|0.38|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.38|0.04|
71854757|NCT00139659|143223189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.01|0.34|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.34|-0.01|
71854758|NCT00139659|143223189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.03|0.32|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.32|-0.03|
71854759|NCT00139659|143223189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||||90.0|-0.12|0.24|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.24|-0.12|
71904945|NCT05086289|143331408|SUPERIORITY||Posterior Mean Difference|9.73|||||TWO_SIDED|95.0|-151.11|170.52|||||Posterior mean difference with 95% credible interval is reported.|||170.52|-151.11|
71904946|NCT03150108|143331418|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% confidence interval (CI).|Geometric mean ratio|1.119|||||TWO_SIDED|90.0|0.875|1.43||||||||1.430|0.875|
71904947|NCT03150108|143331418|OTHER|Dose proportionality|Increase in Cmax per Dose Doubling|1.76|||||TWO_SIDED|90.0|1.52|2.03|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted Cmax using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.03|1.52|
71904948|NCT03150108|143331420|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUClast values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.8|1.23||||||||1.23|0.80|
71680851|NCT04216589|142880340|OTHER|This was a single arm trial.|Mean Difference (Net)|-11.93|STANDARD_DEVIATION|26.4||0.004|TWO_SIDED|95.0|-19.79|-4.08||Not adjusted for multiple comparisons|Regression, Linear|||||-4.08|-19.79|0.004
71680852|NCT04216589|142880341|OTHER|This was a single arm trial.|Mean Difference (Net)|-1.04|STANDARD_DEVIATION|20.5||0.73|TWO_SIDED|95.0|-7.14|5.05||Not adjusted for multiple comparisons|Regression, Linear|||||5.05|-7.14|0.73
71854760|NCT00139659|143223189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.12||||90.0|-0.19|0.22|||Mixed Models Analysis|||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.||0.22|-0.19|
71854761|NCT00139659|143223190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.615|STANDARD_ERROR_OF_MEAN|7.874||||90.0|-2.351|23.581|||Mixed Models Analysis|Confidence interval for the LS mean of that particular treatment.||Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||23.581|-2.351|
71854762|NCT00139659|143223190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.942|STANDARD_ERROR_OF_MEAN|7.804||||90.0|-19.79|5.909|||Mixed Models Analysis|||Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||5.909|-19.79|
71854763|NCT00139659|143223190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.622|STANDARD_ERROR_OF_MEAN|7.897||||90.0|-17.63|8.382|||Mixed Models Analysis|||Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||8.382|-17.63|
71854764|NCT00139659|143223190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.828|STANDARD_ERROR_OF_MEAN|7.888||||90.0|-11.16|14.817|||Mixed Models Analysis|||Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.817|-11.16|
71854765|NCT00139659|143223190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.149|STANDARD_ERROR_OF_MEAN|7.991||||90.0|-12.01|14.307|||Mixed Models Analysis|||Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||14.307|-12.01|
71854766|NCT00139659|143223190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.247|STANDARD_ERROR_OF_MEAN|7.816||||90.0|-8.664|17.157|||Mixed Models Analysis|||Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.||17.157|-8.664|
71854767|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.455||||90.0|-1.829|-0.331|||Mixed Models Analysis|||Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.331|-1.829|
71854768|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.475|STANDARD_ERROR_OF_MEAN|0.461||||90.0|-1.233|0.284|||Mixed Models Analysis|||Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.284|-1.233|
71854769|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.185|STANDARD_ERROR_OF_MEAN|0.454||||90.0|-0.931|0.562|||Mixed Models Analysis|||Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.562|-0.931|
71854770|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.189|STANDARD_ERROR_OF_MEAN|0.449||||90.0|-0.929|0.55|||Mixed Models Analysis|||Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.550|-0.929|
71854771|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.447||||90.0|-1.294|0.178|||Mixed Models Analysis|||Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.178|-1.294|
71854772|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.748|STANDARD_ERROR_OF_MEAN|0.467||||90.0|-1.517|0.022|||Mixed Models Analysis|||Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.022|-1.517|
71854773|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|STANDARD_ERROR_OF_MEAN|0.886||||90.0|-2.51|0.405|||Mixed Models Analysis|||Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.405|-2.510|
71921924|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-8.1|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-21.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||5.6|-21.7|
71854774|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.891|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.634|-0.149|||Mixed Models Analysis|||Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.149|-1.634|
71854775|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.453||||90.0|-1.725|-0.234|||Mixed Models Analysis|||Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||-0.234|-1.725|
71854776|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.663|STANDARD_ERROR_OF_MEAN|0.448||||90.0|-1.4|0.075|||Mixed Models Analysis|||Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.075|-1.400|
71854777|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.537|STANDARD_ERROR_OF_MEAN|0.451||||90.0|-1.279|0.205|||Mixed Models Analysis|||Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.205|-1.279|
71854778|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322|STANDARD_ERROR_OF_MEAN|1.027||||90.0|-3.012|0.369|||Mixed Models Analysis|||Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.369|-3.012|
71854779|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.063|STANDARD_ERROR_OF_MEAN|0.552||||90.0|-0.847|0.972|||Mixed Models Analysis|||Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.972|-0.847|
71854780|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.193|STANDARD_ERROR_OF_MEAN|0.469||||90.0|-0.964|0.579|||Mixed Models Analysis|||Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.579|-0.964|
71921925|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-17.7|7.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15 / Discharge||7.6|-17.7|
71904949|NCT03150108|143331420|OTHER|Dose proportionality|Increase in AUClast per Dose Doubling|2.35||||||90.0|2.06|2.7|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUClast using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.70|2.06|
71904950|NCT03150108|143331421|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-8 values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.08|||||TWO_SIDED|90.0|0.87|1.35||||||||1.35|0.87|
71904951|NCT03150108|143331421|OTHER|Dose proportionality|Increase in AUC0-8 per Dose Doubling|2.23|||||TWO_SIDED|90.0|1.98|2.51|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-8 using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.51|1.98|
71904952|NCT03150108|143331422|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-inf values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.01|||||TWO_SIDED|90.0|0.77|1.33||||||||1.33|0.77|
71904953|NCT03150108|143331422|OTHER|Dose proportionality|Increase in AUC0-inf per Dose Doubling|2.31|||||TWO_SIDED|90.0|1.96|2.71|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline-adjusted AUC0-inf using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.||2.71|1.96|
71904954|NCT03150108|143331428|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.13|||||TWO_SIDED|90.0|0.9|1.4||||||||1.40|0.90|
71854781|NCT00139659|143223191|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.526||||90.0|-1.298|0.438|||Mixed Models Analysis|||Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.||0.438|-1.298|
71904955|NCT03150108|143331430|EQUIVALENCE|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.08|||||TWO_SIDED|90.0|0.93|1.25||||||||1.25|0.93|
71904956|NCT01975935|143331439|SUPERIORITY|||||||0.05||||||This is the calculated p value and not the threshold for statistical significance.|t-test, 2 sided|||||||0.05
71904957|NCT01975935|143331440|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||0.38
71904958|NCT01975935|143331441|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.51
71904959|NCT00807846|143331448|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.274|TWO_SIDED|90.0|-0.56|2.76|||ANCOVA|||The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib - naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.||2.76|-0.56|0.274
71904960|NCT00807846|143331449|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.088||||0.148|TWO_SIDED|95.0|-0.39|2.57|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||2.57|-0.39|0.148
71904961|NCT00807846|143331450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.837||||0.027|TWO_SIDED|95.0|0.21|3.46|||ANCOVA|||"For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05."||3.46|0.21|0.027
71904962|NCT00807846|143331451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.207||||0.106|TWO_SIDED|95.0|-2.67|0.26|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||0.26|-2.67|0.106
71854782|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.079|0.0|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.000|-0.079|
71904963|NCT00807846|143331452|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22||||0.776|TWO_SIDED|95.0|-1.3|1.74|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.74|-1.30|0.776
71904964|NCT00807846|143331453|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.815|TWO_SIDED|95.0|-1.69|1.33|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib - naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.||1.33|-1.69|0.815
71904965|NCT00807846|143331454|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.033||||0.303|TWO_SIDED|95.0|-2.76|8.82|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||8.82|-2.76|0.303
71904966|NCT00807846|143331455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.061||||0.392|TWO_SIDED|95.0|-0.202|0.079|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.079|-0.202|0.392
71904967|NCT00807846|143331456|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.402||||0.897|TWO_SIDED|95.0|-6.5|5.69|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.||5.69|-6.50|0.897
71904968|NCT00807846|143331457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.102||||0.2|TWO_SIDED|95.0|-0.257|0.053|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.||0.053|-0.257|0.200
71904969|NCT02491073|143331486|OTHER||geometric mean ratio|1.05||||1.05|TWO_SIDED|90.0|0.98|1.09|||geometric mean ration||The parameter dispersion type:Geometric coefficient of variation Dispersion Value: FT4: 0.220|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.09|0.98|1.05
71904970|NCT02491073|143331486|OTHER||Geometric Mean Ratio|1.15|||||TWO_SIDED|90.0|1.09|1.22|||Geometric Mean Ratio||parameter dispersion type: Geometric Coefficient of Variation Dispersion Value : FT3: 0.178|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.22|1.09|
71904971|NCT02491073|143331487|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|1.01|1.03|||||Parameter dispersion type: geometric coefficient of variation dispersion value 0.024|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.01|
71904972|NCT02491073|143331487|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|1.03|1.04|||||parameter dispersion value - geometric coefficient of variation dispersion value - 0.020|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.03|
71904973|NCT02491073|143331487|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.05|||||TWO_SIDED|90.0|1.05|1.06|||||parameter dispersion type - geometric coefficient variation dispersion value - 0.021|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.06|1.05|
71854783|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.068|0.01|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.010|-0.068|
71854784|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.084|-0.006|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.006|-0.084|
71854785|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
71854786|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.085|-0.007|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.007|-0.085|
71854787|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.024||||90.0|-0.063|0.017|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.017|-0.063|
71854788|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.062|0.02|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.020|-0.062|
71854789|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.025||||90.0|-0.055|0.027|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.027|-0.055|
71854790|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.026||||90.0|-0.085|0.0|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.000|-0.085|
71854791|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.027||||90.0|-0.109|-0.022|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.022|-0.109|
71904974|NCT02491073|143331487|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type -geometric coefficient of variation dispersion value - 0.040|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|0.99|
71904975|NCT02491073|143331487|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geotmetric mean ratio|1.02|||||TWO_SIDED|90.0|1.0|1.03|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.03|1.00|
71904976|NCT02491073|143331487|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.03|||||TWO_SIDED|90.0|1.02|1.04|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.04|1.02|
71854792|NCT00139659|143223199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.028||||90.0|-0.097|-0.003|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.003|-0.097|
71854793|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.279|STANDARD_ERROR_OF_MEAN|0.199||||90.0|-0.606|0.048|||Mixed Models Analysis|||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||0.048|-0.606|
71854794|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.336|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.661|-0.011|||Mixed Models Analysis|||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.011|-0.661|
71854795|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.384|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.707|-0.061|||Mixed Models Analysis|||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.061|-0.707|
71854796|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.516|STANDARD_ERROR_OF_MEAN|0.198||||90.0|-0.842|-0.191|||Mixed Models Analysis|||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.191|-0.842|
71854797|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.474|STANDARD_ERROR_OF_MEAN|0.196||||90.0|-0.797|-0.152|||Mixed Models Analysis|||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.152|-0.797|
71854798|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.533|STANDARD_ERROR_OF_MEAN|0.202||||90.0|-0.866|-0.2|||Mixed Models Analysis|||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.200|-0.866|
71854799|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.509|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.845|-0.174|||Mixed Models Analysis|||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.174|-0.845|
71854800|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.412|STANDARD_ERROR_OF_MEAN|0.204||||90.0|-0.749|-0.076|||Mixed Models Analysis|||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.076|-0.749|
71854801|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.707|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.056|-0.358|||Mixed Models Analysis|||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.358|-1.056|
71854802|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.219||||90.0|-1.04|-0.32|||Mixed Models Analysis|||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.320|-1.040|
71854803|NCT00139659|143223200|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.765|STANDARD_ERROR_OF_MEAN|0.212||||90.0|-1.116|-0.415|||Mixed Models Analysis|||Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.||-0.415|-1.116|
71854804|NCT01747629|143223209|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.163|<|0.0001|TWO_SIDED|95.0|0.59|1.24||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.24|0.59|<0.0001
71904977|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
71680853|NCT04216589|142880342|OTHER|This was a single arm trial.|Mean Difference (Net)|-6.91|STANDARD_DEVIATION|23.1||0.051|TWO_SIDED|95.0|-13.85|0.03||Not adjusted for multiple comparisons|Regression, Linear|||||0.03|-13.85|0.051
71854805|NCT01747629|143223210|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.56|1.55||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.55|0.56|<0.0001
71854806|NCT01747629|143223211|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|0.212||0.0004|TWO_SIDED|95.0|0.35|1.19||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.19|0.35|0.0004
71854807|NCT01747629|143223212|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|0.57|1.28||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.28|0.57|<0.0001
71921926|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|5.7|||TWO_SIDED|95.0|-7.0|16.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.7|-7.0|
71854808|NCT04414397|143223227|SUPERIORITY||Rate Difference|66.9|||<|0.0001|TWO_SIDED|95.0|54.9|78.8||Analysis was performed using the SAS procedure MIANALYZE with normal approximation to generate an associated p-value for the comparison of responder rates between groups.|Multiple imputation regression|||JUVÉDERM® VOLUMA® XC Treatment vs No-treatment control||78.8|54.9|<0.0001
71854809|NCT04414397|143223231|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 visit is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
71854810|NCT04414397|143223232|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean satisfaction score at Month 3 is statistically greater than at Baseline for the treatment group.|t-test, 2 sided|||||||<0.0001
71854811|NCT03418701|143223271|SUPERIORITY||Mean Difference (Final Values)|2.67|||<|0.05|TWO_SIDED|95.0|0.93|4.4|||t-test, 2 sided|||||4.40|0.93|<0.05
71854812|NCT03418701|143223272|SUPERIORITY||Odds Ratio, log|0.47|||<|0.05|TWO_SIDED|95.0|0.22|1.15|||Mixed Models Analysis|A multilevel logistic regression with participants nested within clinic.||||1.15|0.22|<0.05
71854813|NCT04754594|143223279|OTHER||Geometric mean ratio|0.67|||||TWO_SIDED|95.0|0.5|0.9||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||0.90|0.50|
71854814|NCT04754594|143223280|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|95.0|0.91|1.77||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.77|0.91|
71854815|NCT04754594|143223280|OTHER||Geometric mean ratio|0.95|||||TWO_SIDED|95.0|0.69|1.3||||||GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.||1.30|0.69|
71854816|NCT04754594|143223281|OTHER|Vaccine efficacy was estimated by 100\*(1 - illness rate ratio \[IRR\]), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|3.8|||||TWO_SIDED|95.0|-1227.8|93.0||||||||93.0|-1227.8|
71854817|NCT04754594|143223282|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|35.1|||||TWO_SIDED|95.0|-466.5|94.6||||||||94.6|-466.5|
71904978|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
71921927|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-5.8|16.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21 / Follow-up||16.2|-5.8|
71680854|NCT04216589|142880343|OTHER|This was a single arm trial.|Mean Difference (Net)|2.04|STANDARD_DEVIATION|6.96||0.053|TWO_SIDED|95.0|-0.02|4.11||Not adjusted for multiple comparisons|Regression, Linear|||||4.11|-0.02|0.053
71680855|NCT04216589|142880344|OTHER|This was a single arm trial.|Mean Difference (Net)|-0.78|STANDARD_DEVIATION|6.66||0.43|TWO_SIDED|95.0|-2.76|1.2||Not adjusted for multiple comparisons|Regression, Linear|||||1.20|-2.76|0.43
71854818|NCT04754594|143223283|OTHER|Vaccine efficacy was estimated by 100\*(1 - IRR), where IRR=calculated ratio of confirmed COVID-19 illness per 1000 person-years of blinded follow-up in the active vaccine group to the corresponding illness rate in the placebo group.|Vaccine efficacy|40.9|||||TWO_SIDED|95.0|-104.9|86.5||||||||86.5|-104.9|
71854819|NCT00581009|143223316|EQUIVALENCE|repeated measure ANOVA|t-value|3.34|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71854820|NCT02849509|143223317|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
71854821|NCT02849509|143223317|OTHER|||||||0.0174||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0174
71854822|NCT02849509|143223318|OTHER||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||<0.0001
71854823|NCT02849509|143223318|OTHER|||||||0.0004||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0004
71854824|NCT02849509|143223319|OTHER|||||||0.0423||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0423
71854825|NCT02849509|143223319|OTHER|||||||0.2226||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.2226
71854826|NCT02849509|143223320|OTHER|||||||0.0287||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0287
71854827|NCT02849509|143223320|OTHER|||||||0.03||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.0300
71854828|NCT02849509|143223326|OTHER|||||||0.1234||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.1234
71854829|NCT02849509|143223326|OTHER|||||||0.974||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.||||0.9740
71854830|NCT02256488|143223328|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.||1.5|0.667|
71854831|NCT02256488|143223328|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22||1.5|0.667|
71854832|NCT02256488|143223328|NON_INFERIORITY_OR_EQUIVALENCE|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) \> -0.176 and (μlot A - μlot B) \< 0.176 and (μlot A - μlot C) \> -0.176 and (μlot A - μlot C) \< 0.176 and (μlot B - μlot C) \> -0.176 and (μlot B - μlot C) \< 0.176"|Ratio of GMTs|1.12|||||TWO_SIDED|95.0|0.667|1.5|||ANCOVA|||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22||1.5|0.667|
71854833|NCT03859622|143223335|OTHER|Frequencies and percentages for categorical data.||||||||||||Standard methods are used for the description of data (frequencies and percentages for categorical data)||||Standard methods are used for the description of data (frequencies and percentages for categorical data)|Standard methods are used for the description of data (frequencies and percentages for categorical data)|||
71854834|NCT01524887|143223341|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.4||||0.243||95.0|-1.0|3.9|||Mixed Models Analysis|||||3.9|-1.0|0.243
71854835|NCT01524887|143223341|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.0||||0.37||95.0|-1.2|3.3|||Mixed Models Analysis|||||3.3|-1.2|0.370
71854836|NCT01524887|143223342|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-3.9||||0.033||95.0|-7.4|-0.3|||Mixed Models Analysis|||||-0.3|-7.4|0.033
71854837|NCT01524887|143223342|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.9||||0.586||95.0|-4.2|2.4|||Mixed Models Analysis|||||2.4|-4.2|0.586
71680856|NCT04216589|142880345|OTHER|This was a single arm trial.|Mean Difference (Net)|-26.78|STANDARD_DEVIATION|64.8||0.007|TWO_SIDED|95.0|-46.04|-7.53||Not adjusted for multiple comparisons|Regression, Linear|||||-7.53|-46.04|0.007
71854838|NCT01524887|143223343|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.2||||0.501||95.0|-1.0|0.5|||Mixed Models Analysis|||||0.5|-1.0|0.501
71854839|NCT01524887|143223343|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.1||||0.783||95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.783
71854840|NCT01524887|143223344|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|1.1||||0.571||95.0|-2.6|4.7|||Mixed Models Analysis|||||4.7|-2.6|0.571
71854841|NCT01524887|143223344|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|3.7||||0.032||95.0|0.3|7.1|||Mixed Models Analysis|||||7.1|0.3|0.032
71854842|NCT01524887|143223345|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.00026||||0.593||95.0|-0.00126|0.00073|||ANCOVA|||||0.00073|-0.00126|0.593
71854843|NCT01524887|143223345|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.00003||||0.94||95.0|-0.0008|0.00086|||ANCOVA|||||0.00086|-0.00080|0.940
71854844|NCT01524887|143223346|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-0.5||||0.633||95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.633
71854845|NCT01524887|143223346|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|0.0||||0.981||95.0|-2.0|2.0|||Mixed Models Analysis|||||2.0|-2.0|0.981
71854846|NCT04380688|143223365|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.553|||||TWO_SIDED|90.0|0.145|1.952||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.952|0.145|
71854847|NCT04380688|143223373|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|1.314|||||TWO_SIDED|90.0|0.794|2.183||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||2.183|0.794|
71854848|NCT00088452|143223422|SUPERIORITY||Odds Ratio (OR)|2.66|||<|0.001|TWO_SIDED|95.0|1.65|4.28|||Chi-squared||odds ratio with ethosuximide vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||4.28|1.65|<0.001
71854849|NCT00088452|143223422|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.06|5.42|||Chi-squared||odds ratio with valproic acid vs. lamotrigine|Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.||5.42|2.06|<0.001
71854850|NCT00088452|143223423|SUPERIORITY||Odds Ratio (OR)|1.95||||0.03|TWO_SIDED|95.0|1.12|3.41|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the ethosuximide group|||3.41|1.12|0.03
71854851|NCT00088452|143223423|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.001|TWO_SIDED|95.0|1.69|5.49|||Chi-squared||Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the lamotrigine group|||5.49|1.69|<0.001
71854852|NCT00088452|143223424|SUPERIORITY||Odds Ratio (OR)|3.08|||<|0.001|TWO_SIDED|95.0|1.81|5.33|||Fisher Exact||Odds ratio for FFF for ethosuximide versus lamotrigine|||5.33|1.81|<0.001
71904979|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
71921928|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|5.5|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|95.0|-11.7|22.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||22.6|-11.7|
71854853|NCT00088452|143223424|SUPERIORITY||Odds Ratio (OR)|2.88|||<|0.001|TWO_SIDED|95.0|1.68|5.02|||Fisher Exact||odds ratio for FFF for valproic acid versus lamotrigine|||5.02|1.68|<0.001
71854854|NCT02081196|143223431|OTHER||Mean Difference (Net)|4.13|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|3.08|4.77|||||Treatment Effect =Control Flank Change-Treated Flank Change such (a positive results indicates treated area had a larger reduction in fat thickness than control area, and a negative result indicates that a greater reduction was seen in control area).|H0: μ(Control - Treated) \< +1 versus H1: μ(Control - Treated) \> +1||4.77|3.08|
71854855|NCT02081196|143223432|OTHER||sucess proportion|0.8476|||||TWO_SIDED|95.0|0.784|0.913|||||||Descriptive statistics (tabulation of Independent Panel Reviewer ratings) were used to analyze data.|.913|.784|
71854856|NCT01967719|143223458|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|56.57|||||TWO_SIDED|95.0|44.21|72.39|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.||72.39|44.21|
71854857|NCT01967719|143223459|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|55.64|||||TWO_SIDED|95.0|43.3|71.5|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.||71.50|43.30|
71854858|NCT00993798|143223462|SUPERIORITY||LS Mean Difference|-1.27|STANDARD_DEVIATION|0.5||0.012|TWO_SIDED|95.0|-2.25|-0.28|||t-test in ANOVA model|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||-0.28|-2.25|0.012
71854859|NCT00993798|143223463|SUPERIORITY||Median Difference (Final Values)|-8.0||||0.01|TWO_SIDED|95.0|-12.0|0.0|||Wilcoxon (Mann-Whitney)|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.0|-12.0|0.010
71854860|NCT00993798|143223464|SUPERIORITY|||||||0.014|||||||Log Rank|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||||0.014
71854861|NCT00993798|143223465|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.08||0.773|TWO_SIDED|95.0|-0.18|0.14|||ANOVA|||Exploratory comparison between SABER-Bupivacaine and Bupivacaine HCl not analyzed inferentially||0.14|-0.18|0.773
71854862|NCT00871143|143223558|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.001
71854863|NCT00871143|143223558|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.001
71854864|NCT00871143|143223558|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of Type 1 error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between between baseline and 1 month follow up||||< .001
71854865|NCT00871143|143223558|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12||||<.01
71854866|NCT00871143|143223558|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and 1 month follow up||||< 0.05
71854867|NCT00871143|143223559|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.||||<.05
71854868|NCT00871143|143223559|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week measures||||<0.01
71854869|NCT00871143|143223559|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were implemented to adjust for type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up.||||< 0.001
71854870|NCT00871143|143223559|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.||||>0.05
71854871|NCT00871143|143223559|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up measures.||||>0.05
71854872|NCT00871143|143223560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.||||>0.05
71854873|NCT00871143|143223560|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||<0.01
71854874|NCT00871143|143223560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferonni corrections used to reduce risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||>0.05
71854875|NCT00871143|143223560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.||||>0.05
71854876|NCT00871143|143223560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.||||> 0.05
71854877|NCT00871143|143223561|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.||||<0.05
71854878|NCT00871143|143223561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were applied to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.001
71854879|NCT00871143|143223561|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||< 0.001
71854880|NCT00871143|143223561|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni Correction was used in an attempt to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .||||<0.05
71854881|NCT00871143|143223561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to adjust for type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.||||>0.05
71854882|NCT00871143|143223562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.||||>0.05
71854883|NCT00871143|143223562|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||<0.05
71854884|NCT00871143|143223562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
71854885|NCT00871143|143223562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).||||>0.05
71854886|NCT00871143|143223562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.||||> 0.05
71854887|NCT00871143|143223563|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.||||<0.05
71854888|NCT00871143|143223563|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||<0.01
71854889|NCT00871143|143223563|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were implemented to reduce the risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
71854890|NCT00871143|143223563|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.||||>0.05
71854891|NCT00871143|143223563|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.||||> 0.05
71854892|NCT00871143|143223564|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.||||<0.05
71854893|NCT00871143|143223564|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||<0.05
71854894|NCT00871143|143223564|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||< 0.05
71854895|NCT00871143|143223564|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).||||>0.05
71854896|NCT00871143|143223564|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Bonferroni corrections were used|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.||||> 0.05
71854897|NCT00352053|143223565|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.55
71854898|NCT00352053|143223566|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.40
71854899|NCT00352053|143223567|SUPERIORITY_OR_OTHER|||||||0.58||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.58
71854900|NCT00352053|143223568|SUPERIORITY_OR_OTHER|||||||0.37||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).||||0.37
71854901|NCT00352053|143223575|SUPERIORITY_OR_OTHER|||||||0.71||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.71
71854902|NCT00352053|143223576|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).||||0.47
71904980|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator.|1.02|0.99|
71854903|NCT00352053|143223583|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.26
71854904|NCT00352053|143223584|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) \<= or \> median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).||||0.63
71854905|NCT00352053|143223591|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
71854906|NCT00352053|143223592|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).||||0.67
71854907|NCT00352053|143223599|SUPERIORITY_OR_OTHER|||||||1||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||1.00
71854908|NCT00352053|143223600|SUPERIORITY_OR_OTHER|||||||0.38||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.38
71854909|NCT00352053|143223607|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).||||0.22
71854910|NCT00352053|143223608|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).||||0.48
71854911|NCT00352053|143223615|SUPERIORITY_OR_OTHER|||||||0.29||95.0||||No adjustments for multiple comparisons were made.|Log Rank|No adjustments were made.||Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).||||0.29
71854912|NCT01490359|143223620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.008|TWO_SIDED|95.0|1.03|1.71||The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.|generalized estimating equations (GEE)||Estimate is odds ratio (intervention vs. health control).|Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.||1.71|1.03|.008
71854913|NCT00405912|143223628|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.51
71854914|NCT00405912|143223628|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.25
71904981|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Slope|1.01|||||TWO_SIDED|90.0|1.0|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.033|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.02|1.00|
71680857|NCT04216589|142880346|OTHER|This was a single arm trial.|Mean Difference (Net)|-18.65|STANDARD_DEVIATION|49.3||0.014|TWO_SIDED|95.0|-33.29|-4.01||Not adjusted for multiple comparisons|Regression, Linear|||||-4.01|-33.29|0.014
71854915|NCT00405912|143223629|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Fisher Exact|1 sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.52
71854916|NCT00405912|143223629|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.||||0.73
71854917|NCT03730662|143223630|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.99|||<|0.001|TWO_SIDED|97.5|-1.13|-0.86|||Mixed Models Analysis|||||-0.86|-1.13|<0.001
71854918|NCT03730662|143223630|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-1.14|||<|0.001|TWO_SIDED|97.5|-1.28|-1.0|||Mixed Models Analysis|||||-1.00|-1.28|<0.001
71854919|NCT03730662|143223631|NON_INFERIORITY|"Although the primary objective is to establish noninferiority, sample size selection is guided by the objective of establishing superiority. The chosen sample size and randomization ratio also provides \>90% power to establish superiority of 10 mg LY3298176 and 15 mg LY3298176 doses to insulin glargine in absence of confounding effects of rescue therapy for persistent severe hyperglycemia (efficacy estimand)."|Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|97.5|-0.93|-0.66|||Mixed Models Analysis|||||-0.66|-0.93|<0.001
71854920|NCT03730662|143223632|SUPERIORITY||Mean Difference (Net)|-9.0|||<|0.001|TWO_SIDED|95.0|-9.8|-8.3|||Mixed Models Analysis|||||-8.3|-9.8|<0.001
71854921|NCT03730662|143223632|SUPERIORITY||Mean Difference (Net)|-11.4|||<|0.001|TWO_SIDED|95.0|-12.1|-10.6|||Mixed Models Analysis|||||-10.6|-12.1|<0.001
71854922|NCT03730662|143223632|SUPERIORITY||Mean Difference (Net)|-13.5|||<|0.001|TWO_SIDED|95.0|-14.3|-12.8|||Mixed Models Analysis|||||-12.8|-14.3|<0.001
71854923|NCT03730662|143223633|SUPERIORITY||Odds Ratio (OR)|4.78|||<|0.001|TWO_SIDED|95.0|3.47|6.58|||Regression, Logistic|||||6.58|3.47|<0.001
71854924|NCT03730662|143223633|SUPERIORITY||Odds Ratio (OR)|9.23|||<|0.001|TWO_SIDED|95.0|6.31|13.49|||Regression, Logistic|||||13.49|6.31|<0.001
71854925|NCT03730662|143223633|SUPERIORITY||Odds Ratio (OR)|11.87|||<|0.001|TWO_SIDED|95.0|7.88|17.89|||Regression, Logistic|||||17.89|7.88|<0.001
71854926|NCT03730662|143223634|SUPERIORITY||Mean Difference (Net)|1.0||||0.672|TWO_SIDED|95.0|-3.7|5.7|||Mixed Models Analysis|||||5.7|-3.7|0.672
71854927|NCT03730662|143223634|SUPERIORITY||Mean Difference (Net)|-3.6||||0.134|TWO_SIDED|95.0|-8.2|1.1|||Mixed Models Analysis|||||1.1|-8.2|0.134
71854928|NCT03730662|143223634|SUPERIORITY||Mean Difference (Net)|-8.0|||<|0.001|TWO_SIDED|95.0|-12.6|-3.4|||Mixed Models Analysis|||||-3.4|-12.6|<0.001
71854929|NCT01309243|143223640|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL (response rate, as defined by the snapshot analysis algorithm) at Week 48.~Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA \< 50 copies/mL at Week 48."|Difference in the response rates|4.1|||||TWO_SIDED|95.0|-1.1|9.2|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|"The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI \> -12%).~700 subjects allocated 1:1 to either treatment arm was predicted to give \> 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48."||9.2|-1.1|
71904982|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.036|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.99|
71904983|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.047|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
71904984|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.043|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|0.98|
71921929|NCT03091920|143364986|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|7.7|||TWO_SIDED|95.0|-20.4|11.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42 / End of Trial||11.4|-20.4|
71854930|NCT01309243|143223641|SUPERIORITY_OR_OTHER||Difference in the response rates|5.5|||||TWO_SIDED|95.0|-0.6|11.5|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and \> 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|||11.5|-0.6|
71854931|NCT01309243|143223642|SUPERIORITY_OR_OTHER||Difference in LSM|11.0||||0.34|TWO_SIDED|95.0|-11.0|32.0||The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||32|-11|0.34
71854932|NCT01309243|143223643|SUPERIORITY_OR_OTHER||Difference in LSM|20.0||||0.17|TWO_SIDED|95.0|-9.0|49.0||The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, \> 100,000 copies/mL) as fixed effect.|ANOVA|||||49|-9|0.17
71854933|NCT01309243|143223644|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
71854934|NCT01309243|143223645|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
71854935|NCT01309243|143223646|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
71854936|NCT01309243|143223647|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA|||||||< 0.001
71904985|NCT02491073|143331488|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.97|1.0|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.048|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.00|0.97|
71680858|NCT04216589|142880347|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.72||||0.016|TWO_SIDED|95.0|0.55|0.94||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 12 (0.55; 95% CI: 0.43, 0.72) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 12.||0.94|0.55|0.016
71680859|NCT04216589|142880347|OTHER|This was a single arm trial.|Risk Ratio (RR)|0.75||||0.033|TWO_SIDED|95.0|0.58|0.98||Not adjusted for multiple comparisons.|GEE model for repeated binary outcomes|The GEE model used a log link and an unstructured correlation.|The risk ratio is comparing the estimated risk at Week 24 (0.58; 95% CI: 0.46, 0.74) to estimated risk at Baseline (0.77; 95% CI: 0.67, 0.90).|Comparison between Baseline and Week 24.||0.98|0.58|0.033
71854937|NCT03930238|143223650|SUPERIORITY||Group effect from Bayesian linear mixed|1646.0|||||TWO_SIDED|||||We did perform a Bayesian analysis which provided a posterior probability of 99.76% that the daily mean steps in the intervention group exceeded the daily mean steps in the comparison group.|Bayesian linear mixed effects regression||Posterior standard deviation = 578. We have 95% credible intervals - the interval that contains 95% of the posterior probability distribution of the parameter of interest - which ranges from 511 to 2781.|||||
71854938|NCT03930238|143223651|OTHER||Percentage|53.3|||||TWO_SIDED|||||||||||||
71854939|NCT00632931|143223653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||||90.0|-0.28|6.28||||||||6.28|-0.28|
71854940|NCT00632931|143223654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||||90.0|-1.38|4.72||||||||4.72|-1.38|
71854941|NCT00632931|143223655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.07||||||90.0|-0.17|6.31||||||||6.31|-0.17|
71854942|NCT00632931|143223656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.84||||||90.0|-0.4|6.08||||||||6.08|-0.40|
71854943|NCT00632931|143223657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.44||||||90.0|3.21|9.68||||||||9.68|3.21|
71921930|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.9|3.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||3.8|-8.9|
71921931|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.0|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-8.4|4.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||4.5|-8.4|
71854944|NCT00632931|143223658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.33||||||90.0|1.05|7.6||||||||7.60|1.05|
71854945|NCT00632931|143223659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||||90.0|-0.7|6.02||||||||6.02|-0.70|
71854946|NCT00632931|143223660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.51||||||90.0|3.19|9.82||||||||9.82|3.19|
71854947|NCT03009019|143223661|SUPERIORITY||Odds Ratio (OR)|1.4||||0.075|TWO_SIDED|95.0|0.97|2.03|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.03|0.97|0.075
71854948|NCT03009019|143223661|SUPERIORITY||Odds Ratio (OR)|1.47||||0.055|TWO_SIDED|95.0|1.0|2.14|||Fisher Exact|||Observed cases (OC)||2.14|1.00|0.055
71854949|NCT03009019|143223662|SUPERIORITY||Odds Ratio (OR)|1.75||||0.003|TWO_SIDED|95.0|1.22|2.52|||Regression, Logistic|||||2.52|1.22|0.003
71854950|NCT03009019|143223662|SUPERIORITY||Odds Ratio (OR)|1.76||||0.003|TWO_SIDED|95.0|1.22|2.55|||Regression, Logistic|||||2.55|1.22|0.003
71854951|NCT03341312|143223686|SUPERIORITY||ratio of LS Means|0.75|||||TWO_SIDED|95.0|0.42|1.16||||||||1.16|0.42|
71854952|NCT03341312|143223686|SUPERIORITY||ratio of LS Means|0.74|||||TWO_SIDED|95.0|0.49|1.01||||||||1.01|0.49|
71854953|NCT01812707|143223689|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 75 mg Q2W versus placebo~3. Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||<0.0001
71854954|NCT01812707|143223689|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
71854955|NCT01812707|143223689|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Threshold for significance ≤0.05|ANCOVA|||||||<0.0001
71854956|NCT01697592|143223716|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.93|||<|0.001|TWO_SIDED|95.0|-1.1|-0.75|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.75|-1.10|<0.001
71854957|NCT01697592|143223716|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.37|-0.6|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.60|-1.37|<0.001
71921932|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.2|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||3.4|-9.2|
71921933|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.5|-0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||-0.6|-13.5|
71921934|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.5|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.5|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||0.6|-11.5|
71854958|NCT01697592|143223716|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.92|||<|0.001|TWO_SIDED|95.0|-1.29|-0.56|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.56|-1.29|<0.001
71854959|NCT01697592|143223716|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.16|||<|0.001|TWO_SIDED|95.0|-1.45|-0.88|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.88|-1.45|<0.001
71854960|NCT01697592|143223716|SUPERIORITY_OR_OTHER||Difference in the least squares means|-0.8|||<|0.001|TWO_SIDED|95.0|-1.06|-0.54|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.||||-0.54|-1.06|<0.001
71854961|NCT00265096|143223744|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided \>98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.||||<0.001
71854962|NCT00265096|143223744|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
71854963|NCT00265096|143223744|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||||||<0.001
71854964|NCT00265096|143223745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
71854965|NCT00265096|143223745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
71854966|NCT00265096|143223745|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
71854967|NCT00265096|143223746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline Methotrexate (MTX) usage)||||||<0.001
71904986|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.06|1.16|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.148|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.16|1.06|
71904987|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.07|1.2|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.202|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.20|1.07|
71904988|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||TWO_SIDED|90.0|1.04|1.18|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.18|1.04|
71854968|NCT00265096|143223746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
71854969|NCT00265096|143223746|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject's baseline MTX usage)||||||<0.001
71854970|NCT00265096|143223747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline Methotrexate (MTX) usage)||||||<0.001
71854971|NCT00265096|143223747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (with treatment and subject's baseline MTX usage)||||||<0.001
71854972|NCT00265096|143223747|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject's baseline MTX usage)||||||<0.001
71854973|NCT00265096|143223748|SUPERIORITY_OR_OTHER|||||||0.015||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant.|ANOVA|Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage||Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided \>93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX||||0.015
71854974|NCT00265096|143223748|SUPERIORITY_OR_OTHER|||||||0.011||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.011
71854975|NCT00265096|143223748|SUPERIORITY_OR_OTHER|||||||0.086||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage||||||0.086
71854976|NCT00265096|143223749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)||||||<0.001
71854977|NCT00265096|143223749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
71854978|NCT00265096|143223749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)||||||<0.001
71854979|NCT00666835|143223752|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Point estimate of difference (ANCOVA)|0.084|||||TWO_SIDED|95.0|-0.17|0.338||||||||0.338|-0.170|
71854980|NCT00666835|143223753|EQUIVALENCE|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval -0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (\<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Difference LSM of Epo Hexal & Erypo|0.189|||||TWO_SIDED|95.0|-0.039|0.418||||||||0.418|-0.039|
71854981|NCT03897049|143223758|SUPERIORITY||Odds Ratio (OR)|0.961||||0.914|TWO_SIDED|95.0|0.463|1.994|||Regression, Logistic|||||1.994|0.463|0.914
71904989|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.04|||||TWO_SIDED|90.0|0.99|1.1|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.179|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.|1.10|0.99|
71904990|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.21|||||TWO_SIDED|90.0|1.15|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.178|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.15|
71904991|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.42|||||TWO_SIDED|90.0|1.33|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.224|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.52|1.33|
71904992|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.12|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.12|
71921935|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||1.5|-10.8|
71854982|NCT03897049|143223759|SUPERIORITY||Odds Ratio (OR)|0.979||||0.99|TWO_SIDED|95.0|0.473|2.074|||Regression, Logistic|||||2.074|0.473|0.990
71921936|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-9.4|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||2.2|-9.4|
71921937|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||3.7|-8.0|
71854983|NCT03897049|143223760|SUPERIORITY||Odds Ratio (OR)|1.434||||0.167|TWO_SIDED|95.0|0.861|2.39|||Regression, Logistic|||||2.390|0.861|0.167
71854984|NCT03897049|143223761|SUPERIORITY||Odds Ratio (OR)|1.492||||0.118|TWO_SIDED|95.0|0.903|2.466|||Regression, Logistic|||||2.466|0.903|0.118
71854985|NCT03897049|143223762|SUPERIORITY||Odds Ratio (OR)|1.335||||0.265|TWO_SIDED|95.0|0.803|2.221|||Regression, Logistic|||||2.221|0.803|0.265
71854986|NCT03897049|143223763|SUPERIORITY||Odds Ratio (OR)|0.99||||0.971|TWO_SIDED|95.0|0.593|1.654|||Regression, Logistic|||||1.654|0.593|0.971
71854987|NCT03897049|143223764|SUPERIORITY||Mean Difference (Net)|-0.27||||0.942|TWO_SIDED||||||Regression, Linear|||||||0.942
71854988|NCT03897049|143223765|SUPERIORITY||Mean Difference (Net)|0.02||||0.741|TWO_SIDED||||||Regression, Linear|||||||0.741
71854989|NCT03897049|143223766|SUPERIORITY||Mean Difference (Net)|0.07||||0.494|TWO_SIDED||||||Regression, Linear|||||||0.494
71854990|NCT03897049|143223767|SUPERIORITY||Mean Difference (Net)|0.15||||0.651|TWO_SIDED||||||Regression, Linear|||||||0.651
71854991|NCT03897049|143223768|SUPERIORITY||Mean Difference (Net)|0.3||||0.022|TWO_SIDED||||||Regression, Linear|||||||0.022
71854992|NCT03897049|143223769|SUPERIORITY||Mean Difference (Net)|2.85||||0.189|TWO_SIDED||||||Regression, Linear|||||||0.189
71904993|NCT02491073|143331489|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||TWO_SIDED|90.0|1.11|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.215|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator|1.27|1.11|
71904994|NCT02491073|143331490|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
71904995|NCT02491073|143331490|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator|1.01|1.00|
71904996|NCT02491073|143331490|OTHER|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||TWO_SIDED|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH||1.01|1.00|
71904997|NCT01419665|143331491|EQUIVALENCE|The equivalence margin of + or - 12% was determined considering the variability of the point estimate of the add-on effect by taking a value lower than the lower boundary of the 95% CI for Rituximab+chemotherapy versus chemotherapy obtained from historical data.|difference in overall response rate|-0.4|||||TWO_SIDED|95.0|-5.94|5.14|||Binomial approximation|||||5.14|-5.94|
71904998|NCT01419665|143331494|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|1.3|||||TWO_SIDED|95.0|0.97|1.76|||Regression, Cox|||||1.76|0.97|
71904999|NCT01419665|143331495|OTHER|descriptive purposes, not powered for hypothesis testing|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.55|1.52|||Regression, Cox|||||1.52|0.55|
71905000|NCT00127062|143331529|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71905001|NCT00127062|143331529|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71905002|NCT03731364|143331538|SUPERIORITY|||||||0.276|||||||ANOVA|||||||0.276
71905003|NCT03731364|143331538|SUPERIORITY|||||||0.651|||||||ANOVA|||||||0.651
71905004|NCT03731364|143331538|SUPERIORITY|||||||0.556|||||||ANOVA|||||||0.556
71905005|NCT03731364|143331539|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||||||0.136
71905006|NCT03731364|143331539|SUPERIORITY|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||||||0.649
71905007|NCT03731364|143331539|SUPERIORITY|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||||||0.608
71680860|NCT02326298|142880352|SUPERIORITY||Odds Ratio (OR)|28.962|||<|0.0001|TWO_SIDED|97.5|6.968|120.371||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||120.371|6.968|<0.0001
71905008|NCT03731364|143331540|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
71905009|NCT03731364|143331540|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic|Not estimable|Not estimable|Not estimable||||0
71905010|NCT03731364|143331540|SUPERIORITY||Odds Ratio (OR)|0.0||||0|TWO_SIDED|||||Not estimable|Regression, Logistic||Not estimable|Not estimable||||0
71905011|NCT03731364|143331541|SUPERIORITY|||||||0.306|||||||ANOVA|||||||0.306
71905012|NCT03731364|143331541|SUPERIORITY|||||||0.595|||||||ANOVA|||||||0.595
71905013|NCT03731364|143331541|SUPERIORITY|||||||0.242|||||||ANOVA|||||||0.242
71905014|NCT01934192|143331542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.02|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
71905015|NCT01934192|143331543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|-6.5|10.9||||||||10.9|-6.5|
71905016|NCT01934192|143331544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|7.03|||TWO_SIDED|95.0|-5.1|22.9||||||||22.9|-5.1|
71905017|NCT01934192|143331545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|6.74|||TWO_SIDED|95.0|-6.9|19.9||||||||19.9|-6.9|
71905018|NCT03095521|143331584|NON_INFERIORITY|two-sided 95% CIs estimation used to confirm non-inferior efficacy in primary endpoint. A non-inferiority conclusion was made relating to the primary parameter only.||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||Arm Angal, Arm Antiangin||||0.028
71905019|NCT03095521|143331587|SUPERIORITY|||||||0.482|||||||Wilcoxon (Mann-Whitney)|||||||0.482
71905020|NCT03095521|143331589|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||change from baseline, 2 groups||||0.072
71905021|NCT01536119|143331590|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.27|TWO_SIDED|95.0|0.91|1.38|||Chi-squared|||"Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeks"||1.38|0.91|0.27
71905022|NCT01536119|143331591|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.09||95.0|0.98|1.44|||Chi-squared|||||1.44|0.98|0.09
71905023|NCT01536119|143331592|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.06||95.0|1.0|1.13|||Fisher Exact|||||1.13|1.00|0.06
71905024|NCT01536119|143331593|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.02||95.0|1.01|1.19|||Chi-squared|||||1.19|1.01|0.02
71905025|NCT01536119|143331594|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||Brief scale used||||0.25
71905026|NCT01536119|143331595|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.29
71680861|NCT02326298|142880352|SUPERIORITY||Odds Ratio (OR)|45.66|||<|0.0001|TWO_SIDED|97.5|10.657|195.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||195.634|10.657|<0.0001
71854993|NCT03897049|143223770|SUPERIORITY||Mean Difference (Final Values)|3.07||||0.218|TWO_SIDED||||||Regression, Linear|||||||0.218
71854994|NCT03897049|143223771|SUPERIORITY||Odds Ratio (OR)|0.479||||0.149|TWO_SIDED|95.0|0.173|1.305|||Regression, Logistic|||||1.305|0.173|0.149
71905027|NCT01536119|143331596|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
71905028|NCT01536119|143331597|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
71854995|NCT03897049|143223772|SUPERIORITY||Odds Ratio (OR)|1.111||||0.839|TWO_SIDED|95.0|0.403|3.063|||Regression, Logistic|||||3.063|0.403|0.839
71854996|NCT03897049|143223773|SUPERIORITY||Odds Ratio (OR)|3.302||||0.063|TWO_SIDED|95.0|0.937|11.641|||Regression, Logistic|||||11.641|0.937|0.063
71905029|NCT01536119|143331598|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||t-test, 2 sided|||||||0.06
71905030|NCT01536119|143331599|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
71905031|NCT05301322|143331654|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.86|||||TWO_SIDED|95.0|0.785|0.951|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV A||0.951|0.785|
71905032|NCT05301322|143331654|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for both RSV A and RSV B NTs.|GMR|0.85|||||TWO_SIDED|95.0|0.766|0.943|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|RSV B||0.943|0.766|
71905033|NCT05301322|143331655|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.86|||||TWO_SIDED|95.0|0.769|0.963|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H1N1 A/Victoria||0.963|0.769|
71905034|NCT05301322|143331655|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.77|||||TWO_SIDED|95.0|0.68|0.866|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: H3N2 A/Darwin||0.866|0.680|
71854997|NCT03897049|143223774|SUPERIORITY||Mean Difference (Net)|-0.08||||0.65|TWO_SIDED||||||Regression, Linear|||||||0.650
71854998|NCT03897049|143223775|SUPERIORITY||Mean Difference (Net)|0.09||||0.531|TWO_SIDED||||||Regression, Linear|||||||0.531
71854999|NCT03897049|143223776|SUPERIORITY||Mean Difference (Net)|-0.03||||0.761|TWO_SIDED||||||Regression, Linear|||||||0.761
71905035|NCT05301322|143331655|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.9|||||TWO_SIDED|95.0|0.789|1.019|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Austria||1.019|0.789|
71905036|NCT05301322|143331655|NON_INFERIORITY|Noninferiority was declared if the lower limit of the 2-sided 95% CI for the GMR (Coadministration Group to Sequential-Administration Group) was greater than 0.667 for each of the 4 influenza strains.|GMR|0.87|||||TWO_SIDED|95.0|0.779|0.964|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Coadministration minus Sequential-Administration) and the corresponding CIs (based on Student's t distribution).|HAI: B/Phuket||0.964|0.779|
71905037|NCT03829332|143331696|OTHER||Hazard Ratio (HR)|0.78||||0.00624|TWO_SIDED|95.0|0.64|0.95|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||Hazards ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||0.95|0.64|0.00624
71905038|NCT03829332|143331697|OTHER||Hazard Ratio (HR)|1.1||||0.79744|TWO_SIDED|95.0|0.87|1.39|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG, region, and baseline PD-L1 status.||HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||1.39|0.87|0.79744
71905039|NCT03829332|143331698|OTHER||Percent Difference|12.8||||0.00037|TWO_SIDED|95.0|5.4|20.1|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Percent difference and 95% CI were calculated using Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).||20.1|5.4|0.00037
71905040|NCT03829332|143331701|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-3.9||||0.0262|TWO_SIDED|95.0|-7.34|-0.47|||Constrained longitudinal data analysis|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||-0.47|-7.34|0.0262
71905041|NCT03829332|143331702|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-4.5||||0.0461|TWO_SIDED|95.0|-8.91|-0.08||Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.|cLDA model|||||-0.08|-8.91|0.0461
71680862|NCT02326298|142880352|SUPERIORITY||Estimated difference in responder rate|60.0|||||TWO_SIDED|95.0|47.92|72.17|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||72.17|47.92|
71680863|NCT02326298|142880352|SUPERIORITY||Estimated difference in responder rate|69.3|||||TWO_SIDED|95.0|57.65|80.99|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||80.99|57.65|
71855000|NCT03897049|143223777|SUPERIORITY||Mean Difference (Net)|0.11||||0.503|TWO_SIDED||||||Regression, Linear|||||||0.503
71905042|NCT03829332|143331703|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-1.1||||0.5596|TWO_SIDED|95.0|-4.78|2.59|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||2.59|-4.78|0.5596
71855001|NCT03897049|143223778|SUPERIORITY||Mean Difference (Net)|0.01||||0.541|TWO_SIDED||||||Regression, Linear|||||||0.541
71855002|NCT03897049|143223779|SUPERIORITY||Mean Difference (Net)|-0.02||||0.537|TWO_SIDED||||||Regression, Linear|||||||0.537
71905043|NCT03829332|143331704|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-0.88||||0.7088|TWO_SIDED|95.0|-5.49|3.74|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||3.74|-5.49|0.7088
71855003|NCT03897049|143223780|SUPERIORITY||Mean Difference (Net)|0.19||||0.057|TWO_SIDED||||||Regression, Linear|||||||0.057
71855004|NCT03897049|143223781|SUPERIORITY||Mean Difference (Net)|0.1||||0.402|TWO_SIDED||||||Regression, Linear|||||||0.402
71855005|NCT03897049|143223782|SUPERIORITY||Mean Difference (Net)|0.15||||0.308|TWO_SIDED||||||Regression, Linear|||||||0.308
71855006|NCT03897049|143223783|SUPERIORITY||Mean Difference (Net)|0.48||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
71855007|NCT03319719|143223784|SUPERIORITY||Mean Difference (Net)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.42|-2.33||p-value from paired two-sided t-tests of no difference between test and control groups.|t-test, 2 sided|||||-2.33|-3.42|<0.0001
71855008|NCT01212952|143223790|OTHER||Maximum Tolerated Dose (MTD) (mg/m^2)|1.3|||||TWO_SIDED||||||||Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m\^2 Bortezomib).|||||
71855009|NCT02236598|143223798|SUPERIORITY|||||||0.5582|||||||ANCOVA|||||||0.5582
71855010|NCT02236598|143223799|SUPERIORITY|Change in Fasting Glucose||||||0.0963|||||||ANCOVA|||||||0.0963
71855011|NCT02236598|143223799|SUPERIORITY|Change in 1-hour Glucose||||||0.6671|||||||ANCOVA|||||||0.6671
71855012|NCT02236598|143223799|SUPERIORITY|Change in 2-hour Glucose||||||0.7913|||||||ANCOVA|||||||0.7913
71855013|NCT02236598|143223800|SUPERIORITY|||||||0.5294|||||||ANCOVA|||||||0.5294
71855014|NCT02236598|143223801|SUPERIORITY|||||||0.1604|||||||ANCOVA|||||||0.1604
71855015|NCT01061775|143223813|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.05
71855016|NCT01061775|143223814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71855017|NCT01061775|143223815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71905044|NCT03829332|143331705|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS means|-3.01||||0.1116|TWO_SIDED|95.0|-6.71|0.7|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG, region \& baseline PDL-1.||||0.70|-6.71|0.1116
71905045|NCT03829332|143331706|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.0||||0.9601|TWO_SIDED|95.0|0.75|1.33|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.33|0.75|0.9601
71855018|NCT01061775|143223816|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71855019|NCT04089332|143223849|OTHER||Slope|-0.4465||||0.162|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs HOMA-IR|Adjusted R-squared = 0.117|||0.162
71855020|NCT04089332|143223849|OTHER||Slope|0.6704||||0.082|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs HOMA-IR|Adjusted R-squared = 0.221|||0.082
71905046|NCT03829332|143331707|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|0.61||||0.0079|TWO_SIDED|95.0|0.42|0.88|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||0.88|0.42|0.0079
71855021|NCT04089332|143223849|OTHER||Slope|-0.8486||||0.286|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs HOMA-IR|Adjusted R-squared = 0.0503|||0.286
71855022|NCT04089332|143223849|OTHER||Slope|-0.0266||||0.635|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs HOMA-IR|Adjusted R-squared = 0|||0.635
71855023|NCT04089332|143223849|OTHER||Slope|-0.1588||||0.061|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs HOMA-IR|Adjusted R-squared = 0.381|||0.061
71855024|NCT04089332|143223849|OTHER||Slope|0.099||||0.479|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. HOMA-IR|Adjusted R-squared = 0|||0.479
71855025|NCT04089332|143223849|OTHER||Slope|0.0676||||0.965|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. HOMA-IR|Adjusted R-squared = 0|||0.965
71855026|NCT04089332|143223849|OTHER||Slope|-0.0091||||0.039|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. HOMA-IR|Adjusted R-squared = 0.324|||0.039
71855027|NCT04089332|143223849|OTHER||Slope|-4.2085||||0.018|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. HOMA-IR|Adjusted R-squared = 0.0423|||0.018
71855028|NCT04089332|143223850|OTHER||Slope|-1.1138||||0.558|TWO_SIDED||||||Regression, Linear|||Change in Gray Matter Perfusion vs. HOMA-IR|Adjusted R-square = 0|||0.558
71855029|NCT04089332|143223850|OTHER||Slope|-5.8089||||0.057|TWO_SIDED||||||Regression, Linear|||Baseline Gray Matter vs. HOMA-IR|Adjusted R-squared = 0.18|||0.057
71855030|NCT04089332|143223851|OTHER||Slope|-0.4465||||0.377|TWO_SIDED||||||Regression, Linear|||WASI II (Verbal IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.377
71855031|NCT04089332|143223851|OTHER||Slope|0.6704||||0.402|TWO_SIDED||||||Regression, Linear|||WASI II (Performance IQ) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.402
71855032|NCT04089332|143223851|OTHER||Slope|-0.8486||||0.203|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Flanker Inhibitory Control and Attention) vs. Cerebral Blood Flow|Adjusted R-squared = 0.207|||0.203
71855033|NCT04089332|143223851|OTHER||Slope|-0.0266||||0.967|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Pattern Comparison) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.967
71855034|NCT04089332|143223851|OTHER||Slope|-0.1588||||0.616|TWO_SIDED||||||Regression, Linear|||NIH Toolbox (Picture Sequence) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.616
71855035|NCT04089332|143223851|OTHER||Slope|0.099||||0.287|TWO_SIDED||||||Regression, Linear|||WRAML (Picture Memory) vs. Cerebral Blood Flow|Adjusted R-squared = 0.0497|||0.287
71855036|NCT04089332|143223851|OTHER||Slope|0.0676||||0.225|TWO_SIDED||||||Regression, Linear|||D-KEFS (Color-Word Interference) vs. Cerebral Blood Flow|Adjusted R-squared = 0.106|||0.225
71855037|NCT04089332|143223851|OTHER||Slope|-0.0091||||0.872|TWO_SIDED||||||Regression, Linear|||D-KEFS (Trail Making Test) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.872
71855038|NCT04089332|143223851|OTHER||Slope|-4.2085||||0.66|TWO_SIDED||||||Regression, Linear|||PedsQL (Child 8-12 / Teen 13-18) vs. Cerebral Blood Flow|Adjusted R-squared = 0|||0.66
71855039|NCT02963922|143224100|SUPERIORITY|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised participants regardless of premature discontinuation of trial product.|Treatment difference|-4.32|STANDARD_ERROR_OF_MEAN|0.59|<|0.0001|TWO_SIDED|95.0|-5.48|-3.16|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.||-3.16|-5.48|< .0001
71905047|NCT03829332|143331708|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.06||||0.7457|TWO_SIDED|95.0|0.73|1.56|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.56|0.73|0.7457
71905048|NCT03829332|143331709|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.04||||0.8122|TWO_SIDED|95.0|0.75|1.44|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.44|0.75|0.8122
71905049|NCT03829332|143331710|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.24||||0.148|TWO_SIDED|95.0|0.92|1.67|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||1.67|0.92|0.1480
71905050|NCT03829332|143331711|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (1% to 49% versus \>=50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG, region and baseline PD-L1 status.||||2.46|0.70|0.4068
71905051|NCT02115113|143331767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.24|STANDARD_ERROR_OF_MEAN|5.01||0.3013|TWO_SIDED|95.0|-4.86|15.34|||ANOVA|||||15.34|-4.86|0.3013
71905052|NCT02622724|143331772|SUPERIORITY|||||||0.8219|||||||Van Elteren hypothesis test|||A non-parametric analysis has been used as the data distribution was skewed. This involved a generalised Wilcoxon rank sum-based stratification test which assigns ranks within strata and compares two treatments within strata (Van Elteren hypothesis test).||||0.8219
71905053|NCT02622724|143331779|SUPERIORITY|||||||0.4678|||||||Van Elteren p-values|||Van Elteren hypothesis test was used as the distribution was non-normal and negatively skewed by patients who are assigned scores of zero in the event of death.||||0.4678
71905054|NCT02622724|143331784|SUPERIORITY||||||<|0.05|||||||ANCOVA|Analysis of covariance (ANCOVA) model using Type III sums of squares with Treatment, Severity, and Country fixed effect factors, Baseline as covariate||||||<0.05
71905055|NCT02622724|143331787|OTHER||Least Squares Mean|31.1|||>|0.05|TWO_SIDED|95.0|-37.7|99.9|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95% Confidence Intervals) for the overall treatment difference for maximum distance walked on Day 180.||99.9|-37.7|>0.05
71905056|NCT02622724|143331801|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL -1ra - changes in levels from baseline to Day 14||||>0.05
71905057|NCT02622724|143331801|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL- 6 - changes in levels from baseline to Day 14||||>0.05
71905058|NCT02622724|143331801|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED|95.0|||||ANCOVA|ANCOVA estimates (LS means and a 95% CI for the treatment difference) were presented for all numeric biomarker variables.||FGF basic - changes in levels from baseline to Day 14||||<0.05
71905059|NCT02622724|143331801|OTHER||LS Means difference|0.0|||<|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IP-10 - changes in levels from baseline to Day 14.||||<0.05
71905060|NCT02622724|143331801|OTHER||LS Means difference|0.0|||>|0.05|ONE_SIDED||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||TNF-α - changes in levels from baseline to Day 14||||>0.05
71905061|NCT02622724|143331802|OTHER||||||<|0.007||||||The p-value is not adjusted for multiple comparisons.|Chi-squared|||||||<0.007
71905062|NCT02622724|143331805|OTHER||Least Squares Mean|28.0|||>|0.05|TWO_SIDED|95.0|-54.0|110.1|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95 % Confidence Intervals) for the overall treatment difference for maximun distance walked on Day 360.||110.1|-54|>0.05
71905063|NCT00485589|143331839|NON_INFERIORITY|Pre-specified analysis||||||0.001|||||||Van Elteren's test|||||||0.001
71905064|NCT00485589|143331839|NON_INFERIORITY|Pre-specified analysis||||||0.0033|||||||Van Elteren's test|||||||0.0033
71905065|NCT02924688|143331854|SUPERIORITY||Least Squares Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.0222|<|0.001|TWO_SIDED|95.0|0.052|0.139||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study inhaled corticosteroids (ICS) dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.139|0.052|<0.001
71905066|NCT02924688|143331854|SUPERIORITY||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.066|0.153||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.153|0.066|<0.001
71905067|NCT02924688|143331854|SUPERIORITY||Least Squares Mean Difference|0.082|STANDARD_ERROR_OF_MEAN|0.0221|<|0.001|TWO_SIDED|95.0|0.039|0.125||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.125|0.039|<0.001
71905068|NCT02924688|143331854|SUPERIORITY||Least Squares Mean Difference|0.092|STANDARD_ERROR_OF_MEAN|0.022|<|0.001|TWO_SIDED|95.0|0.049|0.135||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.135|0.049|<0.001
71855040|NCT02963922|143224100|SUPERIORITY|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised participants assuming that all participants remained on trial product (on-treatment principle).|Treatment difference|-5.1|STANDARD_ERROR_OF_MEAN|0.61|<|0.0001|TWO_SIDED|95.0|-6.3|-3.91|||MMRM||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.||-3.91|-6.30|< .0001
71855041|NCT02963922|143224101|SUPERIORITY||Odds Ratio (OR)|3.41|||<|0.0001|TWO_SIDED|95.0|2.19|5.31|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.||5.31|2.19|<.0001
71855042|NCT02963922|143224101|SUPERIORITY||Odds Ratio (OR)|4.73|||<|0.0001|TWO_SIDED|95.0|3.04|7.36|||Mixed model for repeated measurements||Liraglutide 3.0 mg/Placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.||7.36|3.04|<.0001
71855043|NCT03740919|143224178|NON_INFERIORITY|Noninferiority margin \[NIM\]=0.4% for HbA1c|Least Squares (LS) Mean Difference|-0.02||||0.783|TWO_SIDED|95.0|-0.17|0.13|||Mixed Models Analysis|||||0.13|-0.17|0.783
71855044|NCT03740919|143224179|NON_INFERIORITY|NIM of 0.4%|LS Mean Difference|-0.02||||0.867|TWO_SIDED|95.0|-0.2|0.17|||Mixed Models Analysis|||||0.17|-0.20|0.867
71855045|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|1.61||||0.008|TWO_SIDED|95.0|1.13|2.3|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||2.30|1.13|0.008
71855046|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|1.17||||0.487|TWO_SIDED|95.0|0.75|1.83|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.83|0.75|0.487
71855047|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|0.73||||0.153|TWO_SIDED|95.0|0.47|1.13|||Regression, Logistic|||\< 54 mg/dL 1 hour post-dose||1.13|0.47|0.153
71855048|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|1.49||||0.02|TWO_SIDED|95.0|1.06|2.08|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||2.08|1.06|0.020
71855049|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|1.17||||0.455|TWO_SIDED|95.0|0.78|1.76|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.76|0.78|0.455
71855050|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|0.79||||0.259|TWO_SIDED|95.0|0.52|1.19|||Regression, Logistic|||\< 54 mg/dL 2 hour post-dose||1.19|0.52|0.259
71855051|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.001|TWO_SIDED|95.0|1.29|2.51|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||2.51|1.29|<0.001
71855052|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|0.95||||0.822|TWO_SIDED|95.0|0.64|1.43|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||1.43|0.64|0.822
71855053|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|0.53||||0.003|TWO_SIDED|95.0|0.35|0.8|||Regression, Logistic|||≤ 70 mg/dL 1 hour post-dose||0.80|0.35|0.003
71855054|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|1.42||||0.092|TWO_SIDED|95.0|0.94|2.14|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||2.14|0.94|0.092
71855055|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|0.71||||0.133|TWO_SIDED|95.0|0.45|1.11|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||1.11|0.45|0.133
71855056|NCT03740919|143224180|SUPERIORITY||Odds Ratio (OR)|0.5||||0.004|TWO_SIDED|95.0|0.31|0.8|||Regression, Logistic|||≤ 70 mg/dL 2 hour post-dose||0.80|0.31|0.004
71855057|NCT03740919|143224181|SUPERIORITY|||||||0.22|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.220
71855058|NCT03740919|143224181|SUPERIORITY|||||||0.599|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.599
71855059|NCT03740919|143224181|SUPERIORITY|||||||0.112|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 1 hour post-dose||||0.112
71855060|NCT03740919|143224181|SUPERIORITY|||||||0.034|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.034
71855061|NCT03740919|143224181|SUPERIORITY|||||||0.055|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.055
71855062|NCT03740919|143224181|SUPERIORITY|||||||0.814|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||\< 54 mg/dL 2 hour post-dose||||0.814
71855063|NCT03740919|143224181|SUPERIORITY|||||||0.194|||||||Negative binomial regression|||≤70 mg/dL 1 hour post-dose||||0.194
71855064|NCT03740919|143224181|SUPERIORITY|||||||0.428|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.428
71855065|NCT03740919|143224181|SUPERIORITY|||||||0.057|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 1 hour post-dose||||0.057
71855066|NCT03740919|143224181|SUPERIORITY|||||||0.056|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model||≤70 mg/dL 2 hour post-dose||||0.056
71855067|NCT03740919|143224181|SUPERIORITY|||||||0.435|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.435
71855068|NCT03740919|143224181|SUPERIORITY|||||||0.404|||||||Negative binomial regression|Treatment and age group as covariates, log (exposure/365.25 days) as the offset in the model.||≤70 mg/dL 2 hour post-dose||||0.404
71855069|NCT03740919|143224182|SUPERIORITY||Odds Ratio (OR)|1.04||||0.864|TWO_SIDED|95.0|0.68|1.57|||Regression, Logistic|||\<54 mg/dL||1.57|0.68|0.864
71855070|NCT03740919|143224182|SUPERIORITY||Odds Ratio (OR)|0.69||||0.132|TWO_SIDED|95.0|0.43|1.12|||Regression, Logistic|||\<54 mg/dL||1.12|0.43|0.132
71855071|NCT03740919|143224182|SUPERIORITY||Odds Ratio (OR)|0.67||||0.104|TWO_SIDED|95.0|0.41|1.09|||Regression, Logistic|||||1.09|0.41|0.104
71855072|NCT03740919|143224182|SUPERIORITY||Odds Ratio (OR)|0.8||||0.489|TWO_SIDED|95.0|0.42|1.52|||Regression, Logistic|||≤70 mg/dL||1.52|0.42|0.489
71905069|NCT02924688|143331855|SUPERIORITY||Rate Ratio|0.97||||0.778|TWO_SIDED|95.0|0.81|1.17||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.17|0.81|0.778
71680864|NCT02326298|142880353|SUPERIORITY||Odds Ratio (OR)|20.116|||<|0.0001|TWO_SIDED|97.5|3.699|109.399||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||109.399|3.699|<0.0001
71680865|NCT02326298|142880353|SUPERIORITY||Odds Ratio (OR)|31.143|||<|0.0001|TWO_SIDED|97.5|5.687|170.548||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||170.548|5.687|<0.0001
71680866|NCT02326298|142880353|SUPERIORITY||Estimated difference in responder rate|42.8|||||TWO_SIDED|95.0|30.7|54.86|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||54.86|30.70|
71855073|NCT03740919|143224182|SUPERIORITY||Odds Ratio (OR)|0.45||||0.025|TWO_SIDED|95.0|0.23|0.9|||Regression, Logistic|||≤70 mg/dL||0.90|0.23|0.025
71855074|NCT03740919|143224182|SUPERIORITY||Odds Ratio (OR)|0.57||||0.099|TWO_SIDED|95.0|0.29|1.11|||Regression, Logistic|||≤70 mg/dL||1.11|0.29|0.099
71855075|NCT03740919|143224183|SUPERIORITY|||||||0.732|||||||Negative binomial regression|||\< 54 mg/dL||||0.732
71855076|NCT03740919|143224183|SUPERIORITY|||||||0.638|||||||Negative binomial regression|||\< 54 mg/dL||||0.638
71855077|NCT03740919|143224183|SUPERIORITY|||||||0.462|||||||Negative binomial regression|||\<54 mg/dL||||0.462
71855078|NCT03740919|143224183|SUPERIORITY|||||||0.632|||||||Negative binomial regression|||≤ 70 mg/dL||||0.632
71905070|NCT02924688|143331855|SUPERIORITY||Rate Ratio|0.87||||0.151|TWO_SIDED|95.0|0.72|1.05||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, \>=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.|||1.05|0.72|0.151
71905071|NCT02924688|143331856|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0226|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using Analysis of Covariance (ANCOVA) with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
71905072|NCT02924688|143331856|SUPERIORITY||Least Squares Mean Difference|0.111|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.067|0.155||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.155|0.067|<0.001
71905073|NCT02924688|143331856|SUPERIORITY||Least Squares Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.0225|<|0.001|TWO_SIDED|95.0|0.044|0.132||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.132|0.044|<0.001
71905074|NCT02924688|143331856|SUPERIORITY||Least Squares Mean Difference|0.118|STANDARD_ERROR_OF_MEAN|0.0224|<|0.001|TWO_SIDED|95.0|0.074|0.162||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA|||||0.162|0.074|<0.001
71905075|NCT02924688|143331857|SUPERIORITY||Least Squares Mean Difference|-0.057|STANDARD_ERROR_OF_MEAN|0.034||0.094|TWO_SIDED|95.0|-0.124|0.01||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.010|-0.124|0.094
71905076|NCT02924688|143331857|SUPERIORITY||Least Squares Mean Difference|-0.089|STANDARD_ERROR_OF_MEAN|0.0338||0.008|TWO_SIDED|95.0|-0.156|-0.023||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||-0.023|-0.156|0.008
71905077|NCT02924688|143331858|OTHER||Least Squares Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.697||0.115|TWO_SIDED|95.0|-0.27|2.47||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.47|-0.27|0.115
71905078|NCT02924688|143331858|OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.692||0.662|TWO_SIDED|95.0|-1.66|1.05||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.05|-1.66|0.662
71905079|NCT02924688|143331859|OTHER||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.185||0.479|TWO_SIDED|95.0|-0.49|0.23||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||0.23|-0.49|0.479
71855079|NCT03740919|143224183|SUPERIORITY|||||||0.8|||||||Negative binomial regression|||≤ 70 mg/dL||||0.800
71855080|NCT03740919|143224183|SUPERIORITY|||||||0.889|||||||Negative binomial regression|||≤ 70 mg/dL||||0.889
71905080|NCT02924688|143331859|OTHER||Least Squares Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.184||0.023|TWO_SIDED|95.0|-0.78|-0.06||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures|||||-0.06|-0.78|0.023
71855081|NCT03740919|143224185|SUPERIORITY||LS Mean Difference|0.6||||0.13|TWO_SIDED|95.0|-0.2|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.2|0.130
71855082|NCT03740919|143224185|SUPERIORITY||LS Mean Difference|0.4||||0.404|TWO_SIDED|95.0|-0.5|1.4|||Mixed Models Analysis|||Total Daily Basal Insulin||1.4|-0.5|0.404
71905081|NCT02924688|143331862|OTHER||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.75||0.172|TWO_SIDED|95.0|-2.5|0.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.4|-2.5|0.172
71855083|NCT03740919|143224185|SUPERIORITY||LS Mean Difference|-0.2||||0.693|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||Total Daily Basal Insulin||0.8|-1.2|0.693
71855084|NCT03740919|143224185|SUPERIORITY||LS Mean Difference|0.5||||0.625|TWO_SIDED|95.0|-1.4|2.3|||Mixed Models Analysis|||Total Daily Insulin Dose||2.3|-1.4|0.625
71855085|NCT03740919|143224185|SUPERIORITY||LS Mean Difference|-0.4||||0.758|TWO_SIDED|95.0|-2.6|1.9|||Mixed Models Analysis|||Total Daily Insulin Dose||1.9|-2.6|0.758
71855086|NCT03740919|143224185|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.485|TWO_SIDED|95.0|-3.1|1.5|||Mixed Models Analysis|||Total Daily Insulin Dose||1.5|-3.1|0.485
71855087|NCT03740919|143224186|SUPERIORITY||Odds Ratio (OR)|1.23||||0.396|TWO_SIDED|95.0|0.76|2.0|||Regression, Logistic|||HbA1c \< 7%||2.00|0.76|0.396
71855088|NCT03740919|143224186|SUPERIORITY||Odds Ratio (OR)|0.93||||0.814|TWO_SIDED|95.0|0.49|1.75|||Regression, Logistic|||HbA1c \< 7%||1.75|0.49|0.814
71855089|NCT03740919|143224186|SUPERIORITY||Odds Ratio (OR)|0.75||||0.384|TWO_SIDED|95.0|0.39|1.43|||Regression, Logistic|||HbA1c \< 7%||1.43|0.39|0.384
71855090|NCT03740919|143224186|SUPERIORITY||Odds Ratio (OR)|0.84||||0.4|TWO_SIDED|95.0|0.55|1.27|||Regression, Logistic|||HbA1c \< 7.5%||1.27|0.55|0.400
71855091|NCT03740919|143224186|SUPERIORITY||Odds Ratio (OR)|0.62||||0.094|TWO_SIDED|95.0|0.36|1.08|||Regression, Logistic|||HbA1c \< 7.5%||1.08|0.36|0.094
71855092|NCT03740919|143224186|SUPERIORITY||Odds Ratio (OR)|0.75||||0.306|TWO_SIDED|95.0|0.43|1.31|||Regression, Logistic|||HbA1c \< 7.5%||1.31|0.43|0.306
71855093|NCT03873038|143224200|OTHER|Geometric mean ratio (GMR) was derived using the geometric mean (GM) for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.8|||||TWO_SIDED|90.0|0.54|1.18|||||GMR=GM ESRD/GM Healthy|||1.18|0.54|
71905082|NCT02924688|143331862|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.74||0.436|TWO_SIDED|95.0|-2.0|0.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||0.9|-2.0|0.436
71905083|NCT02924688|143331862|OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.75||0.426|TWO_SIDED|95.0|-0.9|2.1||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.1|-0.9|0.426
71905084|NCT02924688|143331862|OTHER||Least Squares Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.74||0.349|TWO_SIDED|95.0|-0.8|2.2||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP|||2.2|-0.8|0.349
71855094|NCT03873038|143224200|OTHER|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).|GMR|0.53|||||TWO_SIDED|90.0|0.37|0.76|||||GMR=GM ESRD/GM Healthy|||0.76|0.37|
71855095|NCT03873038|143224200|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.55|1.21|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.21|0.55|
71855096|NCT03873038|143224201|OTHER||GMR|1.41|||||TWO_SIDED|90.0|1.07|1.85|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.85|1.07|
71855097|NCT03873038|143224201|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.67|1.11|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001)||1.11|0.67|
71855098|NCT03873038|143224201|OTHER||GMR|0.82|||||TWO_SIDED|90.0|0.62|1.08|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.08|0.62|
71855099|NCT03873038|143224202|OTHER||GMR|1.11|||||TWO_SIDED|90.0|0.84|1.46|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.46|0.84|
71855100|NCT03873038|143224202|OTHER||GMR|0.68|||||TWO_SIDED|90.0|0.52|0.87|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||0.87|0.52|
71855101|NCT03873038|143224202|OTHER||GMR|0.78|||||TWO_SIDED|90.0|0.6|1.03|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.03|0.60|
71855102|NCT03873038|143224203|OTHER||GMR|1.5|||||TWO_SIDED|90.0|1.05|2.14|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||2.14|1.05|
71855103|NCT03873038|143224203|OTHER||GMR|0.91|||||TWO_SIDED|90.0|0.67|1.25|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.25|0.67|
71855104|NCT03873038|143224203|OTHER||GMR|0.86|||||TWO_SIDED|90.0|0.62|1.2|||||GMR=GM ESRD/GM Healthy|GMR was derived using GM for participants with ESRD and the GM from historical data obtained from a study of MK-2060 in healthy participants (PN001).||1.20|0.62|
71855105|NCT00595764|143224214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|||||ANOVA|||With an effect size of 0.46, a sample size of 140 will provide a power of \>.84 with p\<.05 to detect overall differences between the two treatments on the primary outcome measures.||||.91
71855106|NCT00595764|143224216|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.32||0.29|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.29
71855107|NCT00595764|143224217|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.029||0.58|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.58
71855108|NCT00595764|143224218|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.38|STANDARD_ERROR_OF_MEAN|3.63||0.24|TWO_SIDED|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.||||||.24
71855109|NCT01332318|143224223|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.08|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 2 minus Arm 1.|||0.42|0.08|
71855110|NCT01332318|143224223|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.41|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 3 minus Arm 1.|||0.41|0.09|
71855111|NCT01332318|143224223|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.06||||95.0|0.09|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 4 minus Arm 1.|||0.42|0.09|
71855112|NCT02820298|143224253|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|131.41|||||TWO_SIDED|90.0|117.03|147.56|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||147.56|117.03|
71855113|NCT02820298|143224255|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|110.29|||||TWO_SIDED|90.0|103.91|117.06|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||117.06|103.91|
71855114|NCT02820298|143224256|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Ratio of Geometric LSM|108.34|||||TWO_SIDED|90.0|102.48|114.54|||||Ratio of Geometric LSM is the ratio of exponentiated mean difference of log-transformed PK parameter. Confidence interval from ANOVA (linear mixed-effects model) with treatment, period, and sequence as fixed effects, and subject as a random effect.|||114.54|102.48|
71855115|NCT01894256|143224258|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.15|||||TWO_SIDED|90.0|1.04|1.27|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.27|1.04|
71855116|NCT01894256|143224258|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.26|||||TWO_SIDED|90.0|1.06|1.48|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.48|1.06|
71855117|NCT01894256|143224259|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.24|||||TWO_SIDED|90.0|1.06|1.47|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.47|1.06|
71855118|NCT01894256|143224259|SUPERIORITY_OR_OTHER||Geometric least squares means ratio|1.44|||||TWO_SIDED|90.0|1.1|1.89|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.||1.89|1.10|
71855119|NCT01780584|143224270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.8|<|0.05|TWO_SIDED|95.0|1.0|3.0||Repeated Anova was used to determine whether there was difference of FT3 levels between groups|ANOVA|||Null hypothesis: no difference of free T3 (FT3) levels will be found between placebo, low dose and high dose group. We anticipated a difference of 2 pg/ml in FT3 with a standard deviation of 0.8 pg/ml between groups. For a statistical power of 80% to identify a treatment effect and at a level significance of 0.05 (2-sided).||3|1|<0.05
71855120|NCT01780584|143224272|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0||||0.31||95.0|3.0|10.0||Kruskal Wallis test was used to determine any difference of time of extubation between groups.|Kruskal-Wallis|||Null hypothesis: no difference of time to extubation between group. Statistical power 80% and level of significance 0.05||10|3|0.31
71855121|NCT01780584|143224273|SUPERIORITY_OR_OTHER||Median Difference (Net)|50.0||||0.4||95.0|40.0|60.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of length of stay in Intensive Care Unit. Statistical power 80% and level of significance 0.05.||60|40|0.4
71855122|NCT01780584|143224274|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.06||95.0|5.0|15.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of postoperative hospital length of stay between groups. Statistical power 80% and level of significance 0.05.||15|5|0.06
71855123|NCT05329402|143224275|NON_INFERIORITY|"The non-inferiority hypothesis is tenable if the lower limit of 95% confidence interval of the difference in the primary effectiveness evaluation indicator device cutting and anastomosis success rate between the test group and the control group is greater than the non-inferiority critical value (-10%)."|Mean Difference (Final Values)|0.0||||0.9727|TWO_SIDED|95.0|-0.0285|0.0273|||Wald|||||0.0273|-0.0285|0.9727
71905085|NCT02924688|143331862|OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.56||0.482|TWO_SIDED|95.0|-1.5|0.7||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||0.7|-1.5|0.482
71905086|NCT02924688|143331862|OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.56||0.142|TWO_SIDED|95.0|-0.3|1.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.9|-0.3|0.142
71855124|NCT01679613|143224276|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|160.48|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|148.245|173.736||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %).~The standard deviation is actually the geometric coefficient of variation (gCV)."|||173.736|148.245|1.0000
71855125|NCT01679613|143224277|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|179.62|STANDARD_DEVIATION|29.9||1|TWO_SIDED|90.0|157.557|204.779||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV (in %).~Ratio calculated as nintedanib+ketoconazole divided by nintedanib"|||204.779|157.557|1.0000
71855126|NCT01679613|143224278|SUPERIORITY_OR_OTHER||Geometric Mean Ratio in percentage|168.09|STANDARD_DEVIATION|17.9||1|TWO_SIDED|90.0|155.252|181.981||p-value for ratio outside interval 0.8 to 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV.~Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %)."|||181.981|155.252|1.000
71855127|NCT04783519|143224286|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.39||||0.004|TWO_SIDED|95.0|-0.65|-0.127|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-0.127|-0.650|.004
71855128|NCT04783519|143224286|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.21||||0.118|TWO_SIDED|95.0|-0.482|0.054|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||.054|-.482|.118
71855129|NCT04783519|143224286|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.41||||0.003|TWO_SIDED|95.0|-0.674|-0.142|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||-0.142|-0.674|.003
71855130|NCT04783519|143224286|SUPERIORITY||beta coefficient|-0.16||||0.24|TWO_SIDED|95.0|-0.428|0.107|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.107|-0.428|.240
71855131|NCT04783519|143224287|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.88||||0.003|TWO_SIDED|95.0|-8.1|-1.65|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||-1.65|-8.10|.003
71855132|NCT04783519|143224287|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-1.71||||0.308|TWO_SIDED|95.0|-4.98|1.57|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||1.57|-4.98|.308
71855133|NCT04783519|143224287|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-4.52||||0.007|TWO_SIDED|95.0|-7.8|-1.25|||Regression, Linear|Models control for age, sex, race, and ethnicity.||"Changes from Baseline to 3 Month for BASICS+SLEEP vs. AOC reported in this section.~Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/)"||-1.25|-7.8|.007
71855134|NCT04783519|143224287|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|beta coefficient|-0.83||||0.621|TWO_SIDED|95.0|-4.12|2.46|||Regression, Linear|Models control for age, sex, race, and ethnicity.||Changes from Baseline to 3 Month for BASICS vs. AOC reported in this section. Score on measure (T-score method https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261577/ )||2.46|-4.12|.621
71855135|NCT04783519|143224288|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.802||||0.054|TWO_SIDED|95.0|0.641|1.003|||Mixed Models Analysis|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.003|0.641|.054
71855136|NCT04783519|143224288|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.75||||0.015|TWO_SIDED|95.0|0.6|0.946|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.946|0.600|.015
71855137|NCT04783519|143224288|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.736||||0.013|TWO_SIDED|95.0|0.578|0.937|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.937|0.578|.013
71855138|NCT04783519|143224288|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.658||||0.001|TWO_SIDED|95.0|0.513|0.844|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.844|0.513|.001
71855139|NCT04783519|143224289|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.992||||0.96|TWO_SIDED|95.0|0.716|1.374|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.374|0.716|.960
71855140|NCT04783519|143224289|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.782||||0.152|TWO_SIDED|95.0|0.506|1.094|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.094|0.506|.152
71905087|NCT02924688|143331862|OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.806|TWO_SIDED|95.0|-1.2|1.0||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.0|-1.2|0.806
71905088|NCT02924688|143331862|OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.447|TWO_SIDED|95.0|-0.7|1.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP|||1.5|-0.7|0.447
71905089|NCT02924688|143331863|OTHER||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.61||0.034|TWO_SIDED|95.0|0.1|2.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||2.5|0.1|0.034
71905090|NCT02924688|143331863|OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61||0.839|TWO_SIDED|95.0|-1.1|1.3||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.3|-1.1|0.839
71855141|NCT04783519|143224289|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.887||||0.482|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.240|0.634|.482
71855142|NCT04783519|143224289|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.67||||0.02|TWO_SIDED|95.0|0.634|1.24|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||1.240|0.634|.020
71905091|NCT02924688|143331863|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.61||0.349|TWO_SIDED|95.0|-1.8|0.6||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||0.6|-1.8|0.349
71905092|NCT02924688|143331863|OTHER||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.61||0.768|TWO_SIDED|95.0|-1.0|1.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures|||||1.4|-1.0|0.768
71905093|NCT03377244|143331866|SUPERIORITY|||||||0.1013||||||The p-value above reflects results of between-arms analysis of percent change in weight from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1013
71905094|NCT03377244|143331867|SUPERIORITY|||||||0.495||||||The p-value above reflects results of between-arms analysis of change in mean HbA1c from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment.||||||0.4950
71905095|NCT03377244|143331868|SUPERIORITY|||||||0.7416||||||The p-value above reflects results of between-arms analysis of change in systolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.7416
71905096|NCT03377244|143331869|SUPERIORITY|||||||0.0702||||||The p-value above reflects results of between-arms analysis of change in diastolic blood pressure from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0702
71905097|NCT03377244|143331870|SUPERIORITY|||||||0.007||||||The p-value above reflects results of between-arms analysis of change in eating habits self-efficacy scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0070
71905098|NCT03377244|143331871|SUPERIORITY|||||||0.0009||||||The p-value above reflects results of between-arms analysis of change in physical activity self-efficacy scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0009
71905099|NCT03377244|143331872|SUPERIORITY|||||||0.374||||||The p-value above reflects results of between-arms analysis for the probability of participants to engage in sufficient physical activity at 6 months post-intervention.|Regression, Logistic|Model adjusted for age, sex, education, marital status, employment status, and baseline physical activity.||||||0.3740
71905100|NCT03377244|143331873|SUPERIORITY|||||||0.9556||||||The p-value above reflects results of between-arms analysis of change in participants' sugar-sweetened beverage consumption per day from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.9556
71905101|NCT03377244|143331874|SUPERIORITY|||||||0.1726||||||The p-value above reflects results of between-arms analysis of change in participants' fruit and vegetable consumption scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.1726
71905102|NCT03377244|143331875|SUPERIORITY|||||||0.0478||||||The p-value above reflects results of between-arms analysis of change in participants' family support scale scores from baseline to 6 months post-intervention.|general linear model|Model adjusted for age, sex, education, marital status, and employment status.||||||0.0478
71855143|NCT04783519|143224290|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.724||||0.032|TWO_SIDED|95.0|0.54|0.973|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.973|0.540|.032
71855144|NCT04783519|143224290|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.588|||<|0.001|TWO_SIDED|95.0|0.432|0.8|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.800|0.432|<.001
71905103|NCT00174785|143331876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.69|0.84||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason or death for the dronedarone group compared with the placebo group.|||0.84|0.69|<0.0001
71905104|NCT00174785|143331877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.18||95.0|0.66|1.08||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the dronedarone group compared with the placebo group.|||1.08|0.66|0.18
71905105|NCT00174785|143331878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.67|0.82||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason for the dronedarone group compared with the placebo group.|||0.82|0.67|<0.0001
71905106|NCT00174785|143331879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.025||95.0|0.51|0.96||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of cardiovascular death for the dronedarone group compared with the placebo group.|||0.96|0.51|0.025
71905107|NCT00174785|143331880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.03||95.0|0.51|0.98||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The comparison was performed at the 5% level using a 2-sided Log rank|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of adjudicated cardiovascular death for the dronedarone group compared with the placebo group.|||0.98|0.51|0.03
71905108|NCT00120289|143331887|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.8|TWO_SIDED|95.0|0.87|1.21|||Regression, Cox|Adjusting for gender and history of diabetes (randomization stratification factors).||||1.21|0.87|0.80
71905109|NCT00120289|143331888|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.49|TWO_SIDED|95.0|0.87|1.34|||Regression, Cox|||||1.34|0.87|.49
71905110|NCT00120289|143331889|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.9|1.42|||Regression, Cox|||||1.42|0.90|.30
71905111|NCT00120289|143331890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.47|TWO_SIDED|95.0|0.76|1.8|||Regression, Cox|||||1.80|0.76|0.47
71905112|NCT00848250|143331902|SUPERIORITY|||||||0.03|||||||ANOVA|||||||0.03
71905113|NCT00848250|143331903|SUPERIORITY|||||||0.13|||||||ANOVA|Repeated measures||||||0.13
71905114|NCT00848250|143331904|SUPERIORITY|||||||0.02|||||||ANOVA|Repeated measures||||||0.02
71905115|NCT00848250|143331905|SUPERIORITY|||||||0.67|||||||ANOVA|Repeated measures||||||0.67
71905116|NCT00848250|143331907|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-value is for comparison of chest tube output at 24 hours||||0.47
71905117|NCT00848250|143331908|SUPERIORITY|||||||0.41|||||||Fisher Exact|||||||0.41
71905118|NCT01774344|143331967|SUPERIORITY||Hazard Ratio (HR)|0.624|||=|1.7e-05|TWO_SIDED|95.0|0.498|0.782|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.782|0.498|= 0.000017
71855145|NCT04783519|143224291|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.699||||0.009|TWO_SIDED|95.0|0.535|0.914|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.914|0.535|.009
71855146|NCT04783519|143224291|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.675||||0.005|TWO_SIDED|95.0|0.512|0.888|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.888|0.512|.005
71855147|NCT04783519|143224291|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.698||||0.013|TWO_SIDED|95.0|0.526|0.928|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.928|0.526|.013
71855148|NCT04783519|143224291|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.525|||<|0.001|TWO_SIDED|95.0|0.385|0.715|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.715|0.385|<.001
71855149|NCT04783519|143224292|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.598||||0.01|TWO_SIDED|95.0|0.404|0.885|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.885|0.404|.010
71855150|NCT04783519|143224292|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.502||||0.001|TWO_SIDED|95.0|0.331|0.76|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.760|0.331|.001
71855151|NCT04783519|143224292|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.516||||0.002|TWO_SIDED|95.0|0.337|0.79|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||0.790|0.337|.002
71855152|NCT04783519|143224292|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.506||||0.002|TWO_SIDED|95.0|0.33|0.774|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Poisson model to address overdispersion (Negative binomial would not converge).||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.774|0.330|.002
71905119|NCT01774344|143331967|SUPERIORITY||Hazard Ratio (HR)|0.66|||=|0.000149|TWO_SIDED|95.0|0.527|0.828|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.828|0.527|= 0.000149
71905120|NCT01774344|143331967|SUPERIORITY||Hazard Ratio (HR)|0.674|||=|0.000107|TWO_SIDED|95.0|0.546|0.831|||Log Rank|||Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.||0.831|0.546|= 0.000107
71905121|NCT01774344|143331968|SUPERIORITY||Hazard Ratio (HR)|0.439|||<|1e-06|TWO_SIDED|95.0|0.355|0.542|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.542|0.355|< 0.000001
71905122|NCT01774344|143331968|SUPERIORITY||Hazard Ratio (HR)|0.471|||<|1e-06|TWO_SIDED|95.0|0.388|0.572|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.572|0.388|< 0.000001
71905123|NCT01774344|143331968|SUPERIORITY||Hazard Ratio (HR)|0.412|||<|1e-06|TWO_SIDED|95.0|0.334|0.509|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.509|0.334|< 0.000001
71905124|NCT01774344|143331968|SUPERIORITY||Hazard Ratio (HR)|0.444|||<|1e-06|TWO_SIDED|95.0|0.365|0.539|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.||0.539|0.365|< 0.000001
71905125|NCT01774344|143331969|SUPERIORITY||Hazard Ratio (HR)|0.453|||<|1e-06|TWO_SIDED|95.0|0.369|0.555|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.555|0.369|< 0.000001
71905126|NCT01774344|143331969|SUPERIORITY||Hazard Ratio (HR)|0.48|||<|1e-06|TWO_SIDED|95.0|0.397|0.58|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.580|0.397|< 0.000001
71905127|NCT01774344|143331969|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|1e-06|TWO_SIDED|95.0|0.347|0.522|||Log Rank|||Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.522|0.347|< 0.000001
71855153|NCT04783519|143224293|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.628||||0.003|TWO_SIDED|95.0|0.462|0.853|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||0.853|0.462|.003
71855154|NCT04783519|143224293|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.744||||0.073|TWO_SIDED|95.0|0.538|1.028|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.028|0.538|.073
71855155|NCT04783519|143224293|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.764||||0.09|TWO_SIDED|95.0|0.559|1.043|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.043|0.559|.090
71855156|NCT04783519|143224293|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category.|count/rate ratio|0.656||||0.013|TWO_SIDED|95.0|0.469|0.916|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||0.916|0.469|.013
71855157|NCT04783519|143224294|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.753||||0.087|TWO_SIDED|95.0|0.546|1.041|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS+SLEEP vs. AOC reported in this section.||1.041|0.546|.087
71855158|NCT04783519|143224294|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.739||||0.078|TWO_SIDED|95.0|0.528|1.034|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to Post Assessment for BASICS vs. AOC reported in this section.||1.034|0.528|.078
71855159|NCT04783519|143224294|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.773||||0.099|TWO_SIDED|95.0|0.569|1.05|||Generalized linear mixed model|Models control for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS+SLEEP vs. AOC reported in this section.||1.050|0.569|.099
71855160|NCT04783519|143224294|SUPERIORITY|Regression model with TIME × CONDITION Interactions, with AOC as reference category was run using sample of N=150.|count/rate ratio|0.704||||0.031|TWO_SIDED|95.0|0.512|0.969|||Generalized linear mixed model|Model controls for age, sex, race, and ethnicity. Negative binomial model to address overdispersion.||Changes from Baseline to 3 Month Follow-up for BASICS vs. AOC reported in this section.||0.969|0.512|.031
71855161|NCT00645099|143224305|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||Based on available data it was estimated that in the paliperidone ER group the TG:HDL ratio would decrease with 0.15 and that the TG:HDL ratio would increase with 0.25 in the olanzapine group. The common SD of the change was estimated to be 1.4. A sample size of 205 patients in each treatment arm had 80% power to detect a difference of 0.4 in change of TG:HDL ratio after 6 months of treatment in favor of paliperidone ER treatment (Wilcoxon two-sample test with 0.05 two-sided significance level).||||< 0.0001
71855162|NCT00645099|143224305|SUPERIORITY_OR_OTHER|||||||0.4718||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group comparison of the change from baseline at end point.||||0.4718
71855163|NCT00645099|143224305|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline at end point.||||< 0.0001
71855164|NCT00645099|143224306|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
71855165|NCT00645099|143224306|SUPERIORITY_OR_OTHER|||||||0.9143||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.9143
71855166|NCT00645099|143224306|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
71855167|NCT00645099|143224307|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0050
71855168|NCT00645099|143224307|SUPERIORITY_OR_OTHER|||||||0.4454||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.4454
71905128|NCT01774344|143331969|SUPERIORITY||Hazard Ratio (HR)|0.454|||<|1e-06|TWO_SIDED|95.0|0.376|0.548|||Log Rank|||Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.||0.548|0.376|< 0.000001
71905129|NCT01774344|143331970|SUPERIORITY||Difference|-6.88|||=|0.00365|TWO_SIDED|95.0|-11.13|-2.63|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-2.63|-11.13|= 0.003650
71855169|NCT00645099|143224307|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0018
71855170|NCT00645099|143224308|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
71855171|NCT00645099|143224309|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0004
71855172|NCT00645099|143224310|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0272
71855173|NCT00645099|143224311|SUPERIORITY_OR_OTHER|||||||0.1892||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1892
71905130|NCT01774344|143331970|SUPERIORITY||Difference|-4.15|||=|0.019991|TWO_SIDED|95.0|-7.55|-0.75|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-0.75|-7.55|= 0.019991
71855174|NCT00645099|143224312|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.0325
71855175|NCT00645099|143224313|SUPERIORITY_OR_OTHER|||||||0.1117||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1117
71855176|NCT00645099|143224314|SUPERIORITY_OR_OTHER|||||||0.6346||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6346
71855177|NCT00645099|143224315|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||1.0000
71855178|NCT00645099|143224316|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.6770
71855179|NCT00645099|143224317|SUPERIORITY_OR_OTHER|||||||0.1308||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.1308
71855180|NCT00645099|143224318|SUPERIORITY_OR_OTHER|||||||0.3358||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||0.3358
71855181|NCT00645099|143224319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
71855182|NCT00645099|143224319|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||0.0001
71855183|NCT00645099|143224319|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||< 0.0001
71855184|NCT00645099|143224320|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
71855185|NCT00645099|143224321|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||||||<0.0001
71855186|NCT00645099|143224322|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).||||||0.0230
71855187|NCT00645099|143224323|NON_INFERIORITY_OR_EQUIVALENCE|Testing non-inferiority of the paliperidone ER treatment group compared to the olanzapine treatment group, with regard to change versus baseline at end point of the total PANSS was done by means of Schuirmann's test. A difference of 6 points in change versus baseline on the total PANSS was considered to be a minimum clinically relevant difference.The null hypothesis is that there is no difference between paliperidone and olanzapine in change in TG:HDL ratio from baseline to endpoint.||||||0.0242||95.0|||||Schuirmann|The null hypothesis of non-equivalence was rejected and equivalence to within the specified equivalence bounds could be claimed.||||||0.0242
71855188|NCT00645099|143224323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
71855189|NCT00645099|143224323|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.||||<0.0001
71855190|NCT01201915|143224324|SUPERIORITY_OR_OTHER|||||||0.8463|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.8463
71855191|NCT01201915|143224324|SUPERIORITY_OR_OTHER|||||||0.9668|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.||||0.9668
71855192|NCT01201915|143224324|SUPERIORITY_OR_OTHER|||||||0.7878|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.||||0.7878
71855193|NCT00796614|143224359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.5388|TWO_SIDED|95.0|0.5|3.8|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.80|0.50|0.5388
71855194|NCT00796614|143224359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.343|TWO_SIDED|95.0|0.2|1.76|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||1.76|0.20|0.3430
71855195|NCT00796614|143224359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.5209|TWO_SIDED|95.0|0.5|3.97|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.||3.97|0.50|0.5209
71855196|NCT00796614|143224359|SUPERIORITY_OR_OTHER|||||||0.9436|||||||Cochran-Armitage trend test|||A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran-Armitage trend test.||||0.9436
71855197|NCT00796614|143224360|SUPERIORITY_OR_OTHER|||||||0.3097|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.3097
71855198|NCT00796614|143224360|SUPERIORITY_OR_OTHER|||||||0.2676|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.2676
71855199|NCT00796614|143224360|SUPERIORITY_OR_OTHER|||||||0.6265|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6265
71855200|NCT00796614|143224361|SUPERIORITY_OR_OTHER|||||||0.4359|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.4359
71855201|NCT00796614|143224361|SUPERIORITY_OR_OTHER|||||||0.0658|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.0658
71855202|NCT00796614|143224361|SUPERIORITY_OR_OTHER|||||||0.6709|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.||||0.6709
71855203|NCT00796614|143224362|SUPERIORITY_OR_OTHER|||||||0.5672|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5672
71855204|NCT00796614|143224362|SUPERIORITY_OR_OTHER|||||||0.8724|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8724
71855205|NCT00796614|143224362|SUPERIORITY_OR_OTHER|||||||0.7674|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7674
71855206|NCT00796614|143224362|SUPERIORITY_OR_OTHER|||||||0.5545|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5545
71855207|NCT00796614|143224362|SUPERIORITY_OR_OTHER|||||||0.4774|||||||Regression, Logistic|||Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.4774
71855208|NCT00796614|143224362|SUPERIORITY_OR_OTHER|||||||0.8626|||||||Regression, Logistic|||Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8626
71855209|NCT00796614|143224363|SUPERIORITY_OR_OTHER|||||||0.9669|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9669
71855210|NCT00796614|143224363|SUPERIORITY_OR_OTHER|||||||0.9231|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.9231
71855211|NCT00796614|143224363|SUPERIORITY_OR_OTHER|||||||0.636|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.6360
71855212|NCT00796614|143224363|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||1.0000
71855213|NCT00796614|143224363|SUPERIORITY_OR_OTHER|||||||0.4925|||||||Fisher Exact|||Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4925
71855214|NCT00796614|143224363|SUPERIORITY_OR_OTHER|||||||0.4977|||||||Fisher Exact|||Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.||||0.4977
71855215|NCT00796614|143224364|SUPERIORITY_OR_OTHER|||||||0.1373|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.1373
71855216|NCT00796614|143224364|SUPERIORITY_OR_OTHER|||||||0.744|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7440
71855217|NCT00796614|143224364|SUPERIORITY_OR_OTHER|||||||0.7703|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.7703
71905131|NCT01774344|143331971|SUPERIORITY||Difference|-29.31|||<|1e-06|TWO_SIDED|95.0|-37.52|-21.11|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-21.11|-37.52|< 0.000001
71905132|NCT01774344|143331971|SUPERIORITY||Difference|-31.39|||<|1e-06|TWO_SIDED|95.0|-39.57|-23.22|||Cochran-Mantel-Haenszel|||Comparison of treatments were calculated.||-23.22|-39.57|< 0.000001
71905133|NCT01735617|143331980|SUPERIORITY_OR_OTHER||Geometric means|563.38|STANDARD_DEVIATION|162.51|||TWO_SIDED|||||||||The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.||||
71905134|NCT02344407|143331990|SUPERIORITY|||||||0.68|||||||Chi-squared|Bernards Exact Test Chi-square||Each active vaccine is compared to the placebo group||||0.68
71905135|NCT02344407|143331990|SUPERIORITY|||||||0.68|||||||Chi-squared|Barnard Exact Test Chi-square||||||0.68
71905136|NCT02344407|143331991|SUPERIORITY||||||<|0.001|||||||ANCOVA|Linear regression (analysis of covariance) adjusted for baseline antibody level||||||<0.001
71905137|NCT02344407|143331991|SUPERIORITY||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline antibody level||||||<0.001
71905138|NCT01658579|143332016|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|2.179||0.7304|TWO_SIDED|95.0|-3.614|5.124|||Linear Mixed Model|||Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.||5.124|-3.614|0.7304
71905139|NCT00608530|143332027|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||Repeated measures analysis of variance compared differences between and within groups (CBT and Supportive Care) from baseline to end of treatment. Statistical testing was performed using 2-tailed tests and alpha level of .05 for declaring statistical significance. The trial was powered at the \>.80 level to detect differences between condition based on projected sample N = 130; given the N = 66 actually achieved our a priori power for detecting differences between groups was .63.||||.05
71921938|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-13.8|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||3.9|-13.8|
71855218|NCT00796614|143224365|SUPERIORITY_OR_OTHER|||||||0.0808|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.0808
71855219|NCT00796614|143224365|SUPERIORITY_OR_OTHER|||||||0.8244|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.8244
71855220|NCT00796614|143224365|SUPERIORITY_OR_OTHER|||||||0.5045|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.||||0.5045
71855221|NCT01580995|143224370|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71855222|NCT00821119|143224371|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||"Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.~The analysis was performed according to the intention-to-treat principle."||1.14|0.48|<0.05
71855223|NCT00821119|143224372|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7|STANDARD_ERROR_OF_MEAN|0.16||0.05|TWO_SIDED|95.0|0.48|1.14|||risk ratio (RR)|||Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.||1.14|0.48|0.05
71855224|NCT00821119|143224373|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|95.0|0.62|1.78|||risk ratio (RR)|||The study was not powered for this outcome. However this analysis was done with this limitation||1.78|0.62|< 0.05
71855225|NCT03935932|143224374|OTHER|||||||0.11|||||||Wilcoxon signed-rank|||||||0.11
71855226|NCT03935932|143224375|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71855227|NCT03935932|143224376|OTHER|||||||0.35|||||||Wilcoxon signed-rank|||||||0.35
71855228|NCT05109117|143224394|SUPERIORITY||Adjusted Mean Difference|2.8|||<|0.0001|TWO_SIDED|95.0|1.7|3.9|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||3.9|1.7|<0.0001
71855229|NCT05109117|143224394|SUPERIORITY||Adjusted Mean Difference|1.5||||0.0077|TWO_SIDED|95.0|0.4|2.7|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment||2.7|0.4|0.0077
71855230|NCT05109117|143224394|SUPERIORITY||Adjusted Mean Difference|1.8||||0.0019|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment||2.9|0.7|0.0019
71855231|NCT05109117|143224394|SUPERIORITY||Adjusted Mean Difference|1.0||||0.0707|TWO_SIDED|95.0|-0.1|2.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment||2.2|-0.1|0.0707
71855232|NCT02253147|143224474|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.22|||||TWO_SIDED|95.0|-0.34|-0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||-0.11|-0.34|
71855233|NCT00843115|143224509|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
71855234|NCT00843115|143224510|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.||||<0.0001
71855235|NCT00843115|143224511|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855236|NCT00843115|143224512|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71680867|NCT02326298|142880353|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|41.33|65.94|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||65.94|41.33|
71855237|NCT00843115|143224513|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855238|NCT00843115|143224514|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855239|NCT00843115|143224515|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855240|NCT00843115|143224516|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855241|NCT00843115|143224517|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855242|NCT00843115|143224518|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855243|NCT00843115|143224519|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855244|NCT00843115|143224520|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855245|NCT00843115|143224521|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855246|NCT00843115|143224522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855247|NCT00843115|143224523|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855248|NCT00843115|143224524|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855249|NCT00843115|143224525|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855250|NCT00843115|143224526|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855251|NCT00843115|143224527|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855252|NCT00843115|143224528|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855253|NCT00843115|143224529|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5||||<0.0001
71855254|NCT00843115|143224530|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||Change from baseline in total score at Week 12||||<0.0001
71855255|NCT00843115|143224531|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||Change from baseline in total score at Week 12 Last Observation Carried Forward||||<0.0001
71855256|NCT00843115|143224532|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|P value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
71855257|NCT00843115|143224533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||correlation coefficient|p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero||||||<0.0001
71855258|NCT00843115|143224534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
71855259|NCT00843115|143224535|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||<0.0001
71855260|NCT00843115|143224536|SUPERIORITY_OR_OTHER|||||||0.0713|||||||correlation coefficient|||||||0.0713
71855261|NCT00843115|143224537|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Correlation coefficient|||||||0.0225
71855262|NCT00843115|143224538|SUPERIORITY_OR_OTHER|||||||0.0152|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||0.0152
71855263|NCT00843115|143224539|SUPERIORITY_OR_OTHER|||||||0.0229|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||||||0.0229
71855264|NCT00843115|143224540|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
71855265|NCT00843115|143224541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||||||<0.0001
71855266|NCT00843115|143224542|SUPERIORITY_OR_OTHER|||||||0.7963|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12."||||||0.7963
71855267|NCT00843115|143224543|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||1.0000
71855268|NCT00843115|143224544|SUPERIORITY_OR_OTHER|||||||0.0719|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0719
71855269|NCT00843115|143224545|SUPERIORITY_OR_OTHER|||||||0.1779|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."||||||0.1779
71855270|NCT00843115|143224546|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
71855271|NCT00843115|143224547|SUPERIORITY_OR_OTHER|||||||0.8575|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.8575
71855272|NCT00843115|143224548|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||1.0000
71855273|NCT00843115|143224549|SUPERIORITY_OR_OTHER|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||1.0000
71855274|NCT00843115|143224550|SUPERIORITY_OR_OTHER|||||||0.0131|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"||||||0.0131
71855275|NCT00843115|143224551|SUPERIORITY_OR_OTHER|||||||0.0078|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"||||||0.0078
71855276|NCT02621047|143224552|SUPERIORITY_OR_OTHER||Geometric Mean Ratio Percentage (%)|128.0|||||TWO_SIDED|90.0|86.5|188.0||||||||188|86.5|
71855277|NCT02621047|143224552|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|100.0|||||TWO_SIDED|90.0|55.1|183.0||||||||183|55.1|
71855278|NCT02621047|143224553|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|148.0|||||TWO_SIDED|90.0|106.0|208.0||||||||208|106|
71855279|NCT02621047|143224553|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|130.0|||||TWO_SIDED|90.0|75.4|225.0||||||||225|75.4|
71855280|NCT02621047|143224554|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|160.0||||||90.0|105.0|243.0||||||||243|105|
71855281|NCT02621047|143224554|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|220.0||||||90.0|131.0|369.0||||||||369|131|
71855282|NCT02621047|143224555|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|186.0||||||90.0|122.0|281.0||||||||281|122|
71855283|NCT02621047|143224555|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|285.0||||||90.0|175.0|466.0||||||||466|175|
71855284|NCT02621047|143224556|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|162.0|||||TWO_SIDED|90.0|104.0|254.0||||||||254|104|
71855285|NCT02621047|143224556|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|228.0||||||90.0|129.0|403.0||||||||403|129|
71855286|NCT02621047|143224557|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|189.0||||||90.0|121.0|293.0||||||||293|121|
71855287|NCT02621047|143224557|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|296.0|||||TWO_SIDED|90.0|174.0|506.0||||||||506|174|
71855288|NCT02621047|143224558|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|64.6||||||90.0|36.2|115.0||||||||115|36.2|
71855289|NCT02621047|143224558|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|60.8|||||TWO_SIDED|90.0|26.6|139.0||||||||139|26.6|
71855290|NCT02621047|143224559|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|85.1||||||90.0|55.5|130.0||||||||130|55.5|
71855291|NCT02621047|143224559|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|59.0||||||90.0|34.2|102.0||||||||102|34.2|
71855292|NCT02621047|143224560|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|116.0||||||90.0|78.6|172.0||||||||172|78.6|
71855293|NCT02621047|143224560|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|98.1||||||90.0|51.7|186.0||||||||186|51.7|
71855294|NCT02621047|143224561|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|115.0|||||TWO_SIDED|90.0|85.2|154.0||||||||154|85.2|
71855295|NCT02621047|143224561|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6|||||TWO_SIDED|90.0|55.6|168.0||||||||168|55.6|
71855296|NCT02621047|143224562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|80.6||||||90.0|50.2|130.0||||||||130|50.2|
71855297|NCT02621047|143224562|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|65.6|||||TWO_SIDED|90.0|26.9|160.0||||||||160|26.9|
71855298|NCT02621047|143224563|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|104.0||||||90.0|76.8|141.0||||||||141|76.8|
71855299|NCT02621047|143224563|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|63.7|||||TWO_SIDED|90.0|34.0|119.0||||||||119|34.0|
71855300|NCT02621047|143224564|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|136.0|||||TWO_SIDED|90.0|94.7|196.0||||||||196|94.7|
71855301|NCT02621047|143224564|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|176.0||||||90.0|98.4|315.0||||||||315|98.4|
71855302|NCT02621047|143224565|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|134.0||||||90.0|99.6|181.0||||||||181|99.6|
71855303|NCT02621047|143224565|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|157.0|||||TWO_SIDED|90.0|91.8|268.0||||||||268|91.8|
71855304|NCT02621047|143224566|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|73.3|||||TWO_SIDED|90.0|46.2|116.0||||||||116|46.2|
71855305|NCT02621047|143224566|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|57.5|||||TWO_SIDED|90.0|20.0|165.0||||||||165|20.0|
71855306|NCT02621047|143224567|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|96.6||||||90.0|69.9|134.0||||||||134|69.9|
71855307|NCT02621047|143224567|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|55.8||||||90.0|26.0|120.0||||||||120|26.0|
71855308|NCT02621047|143224568|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|139.0|||||TWO_SIDED|90.0|94.8|203.0||||||||203|94.8|
71855309|NCT02621047|143224568|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|180.0||||||90.0|97.2|334.0||||||||334|97.2|
71855310|NCT02621047|143224569|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|137.0|||||TWO_SIDED|90.0|100.0|186.0||||||||186|100|
71855311|NCT02621047|143224569|SUPERIORITY_OR_OTHER||Geometric Mean Ratio %|158.0|||||TWO_SIDED|90.0|91.2|274.0||||||||274|91.2|
71855312|NCT02959177|143224579|SUPERIORITY||LSMean Difference|-3.01|||<|0.001|TWO_SIDED|95.0|-3.8|-2.22|||Mixed Models Analysis|||||-2.22|-3.80|<0.001
71855313|NCT02959177|143224579|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-3.53|-1.94|||Mixed Models Analysis|||||-1.94|-3.53|<0.001
71855314|NCT02959177|143224580|SUPERIORITY||Odds Ratio (OR)|3.89|||||TWO_SIDED|95.0|2.71|5.57||||||||5.57|2.71|
71855315|NCT02959177|143224580|SUPERIORITY||Odds Ratio (OR)|3.664|||||TWO_SIDED|95.0|2.54|5.23||||||||5.23|2.54|
71855316|NCT02959177|143224581|SUPERIORITY||Odds Ratio (OR)|3.24|||||TWO_SIDED|95.0|2.14|4.89||||||||4.89|2.14|
71855317|NCT02959177|143224581|SUPERIORITY||Odds Ratio (OR)|3.16|||||TWO_SIDED|95.0|2.08|4.8||||||||4.80|2.08|
71855318|NCT02959177|143224582|SUPERIORITY||Odds Ratio (OR)|3.47|||||TWO_SIDED|95.0|2.03|5.93||||||||5.93|2.03|
71855319|NCT02959177|143224582|SUPERIORITY||Odds Ratio (OR)|3.13|||||TWO_SIDED|95.0|1.79|5.44||||||||5.44|1.79|
71855320|NCT02959177|143224583|SUPERIORITY||LSMean difference|7.0|||<|0.001|TWO_SIDED|95.0|4.54|9.46|||Mixed Models Analysis|||||9.46|4.54|<0.001
71855321|NCT02959177|143224583|SUPERIORITY||Mean Difference (Final Values)|5.79|||<|0.01|TWO_SIDED|95.0|3.33|8.24|||Mixed Models Analysis|||||8.24|3.33|<0.01
71855322|NCT02959177|143224584|SUPERIORITY||LSMean difference|-2.9|||<|0.001|TWO_SIDED|95.0|-3.61|-2.19|||Mixed Models Analysis|||||-2.19|-3.61|<0.001
71855323|NCT02959177|143224584|SUPERIORITY||LSMean difference|-2.7|||<|0.001|TWO_SIDED|95.0|-3.41|-1.99|||Mixed Models Analysis|||||-1.99|-3.41|<0.001
71855324|NCT02959177|143224586|SUPERIORITY||LSMean Difference|-11.82|||<|0.001|TWO_SIDED|95.0|-16.14|-7.51|||Mixed Models Analysis|||||-7.51|-16.14|<0.001
71855325|NCT02959177|143224586|SUPERIORITY||LSMean difference|-13.73|||<|0.001|TWO_SIDED|95.0|-18.05|-9.4|||Mixed Models Analysis|||||-9.40|-18.05|<0.001
71855326|NCT02959177|143224587|SUPERIORITY||LSMean Difference|-4.9|||<|0.001|TWO_SIDED|95.0|-8.06|-1.73|||Mixed Models Analysis|||||-1.73|-8.06|<0.001
71855327|NCT02959177|143224587|SUPERIORITY||LSMean Difference|-2.97|||<|0.001|TWO_SIDED|95.0|-6.08|0.14|||Mixed Models Analysis|||||0.14|-6.08|<.001
71905140|NCT00608530|143332028|SUPERIORITY|||||||0.05|||||||ANOVA|||Primary analyses consisted of modified intent-to-treat analysis of all randomized participants who attended at least 1 treatment session, with multiple imputation to address missing data. The study was powered at 80% to detect large effect sizes (\>.50SD) and alpha of .05 with a recruitment goal N = 140; with the N = 61 actually obtained, our a priori power was .55 to detect between group differences.||||.05
71905141|NCT00608530|143332029|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||ANOVA|||Repeated measures analysis of variance comparing groups at baseline and end of treatment.||||>0.05
71905142|NCT00608530|143332031|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||.05
71905143|NCT01019486|143332038|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis||||<0.05
71905144|NCT01019486|143332038|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis.||||<0.05
71855328|NCT01947153|143224594|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
71855329|NCT01947153|143224595|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.14|STANDARD_ERROR_OF_MEAN|1.032|<|0.0001|TWO_SIDED|90.0|99.645|110.941||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.941|99.645|<0.0001
71855330|NCT01947153|143224596|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|109.05|STANDARD_ERROR_OF_MEAN|1.063||0.0014|TWO_SIDED|90.0|98.299|120.968||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||120.968|98.299|0.0014
71855331|NCT01947153|143224597|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|105.81|STANDARD_ERROR_OF_MEAN|1.043|<|0.0001|TWO_SIDED|90.0|98.471|113.692||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||113.692|98.471|<0.0001
71855332|NCT01947153|143224598|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|98.48|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|92.177|105.208||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||105.208|92.177|<0.0001
71855333|NCT01947153|143224599|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|104.62|STANDARD_ERROR_OF_MEAN|1.031|<|0.0001|TWO_SIDED|90.0|99.274|110.254||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||110.254|99.274|<0.0001
71855334|NCT01947153|143224600|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence test|Geometric mean ratio|102.92|STANDARD_ERROR_OF_MEAN|1.027|<|0.0001|TWO_SIDED|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.|||107.688|98.370|<0.0001
71855335|NCT01951261|143224601|NON_INFERIORITY|sample size calculation was made, considering it appropriate to set a limit of non-inferiority with respect to the main variable of 1.2 months (36 days), the study being lower if it will have exacerbation before this period of time, with a follow-up of 6 months, It was required to include a sample of 58 patients per group for a potency of 80% and a significance level of 5%.|||||<|0.05||||||The reported p-value was calculated.Statistical analysis of the main variable was performed using the Kaplan-Meier method and log-rank test|Log Rank|||||||<0.05
71855336|NCT01954771|143224613|SUPERIORITY_OR_OTHER||Correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
71855337|NCT01954771|143224613|SUPERIORITY_OR_OTHER||Correlation coefficient|0.522||||0.004|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||0.004
71905145|NCT01019486|143332038|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Independent Student t test between groups with two-tailed analysis||||<0.05
71905146|NCT01019486|143332039|NON_INFERIORITY_OR_EQUIVALENCE|If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.|None insufficient data|2.0||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||No analysis was performed due to limited data.||||0.05
71855338|NCT01954771|143224613|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.784|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.||||<0.001
71855339|NCT01954771|143224613|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.533||||0.011|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.011
71855340|NCT01954771|143224613|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.479||||0.009|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||0.009
71905147|NCT01019486|143332040|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Comparison between groups using a two-tailed Student t test||||<.05
71905148|NCT02130258|143332055|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
71905149|NCT02130258|143332056|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||.04
71905150|NCT02130258|143332057|OTHER|||||||0.04|||||||Kruskal-Wallis|||||||0.04
71905151|NCT03977727|143332059|SUPERIORITY||Mean Difference (Final Values)|27.35||||0.008|TWO_SIDED|95.0|7.88|48.4|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||48.4|7.88|.008
71905152|NCT03977727|143332060|SUPERIORITY||Mean Difference (Final Values)|15.22||||0.136|TWO_SIDED|95.0|-5.42|39.46|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||39.46|-5.42|.136
71680868|NCT02326298|142880354|SUPERIORITY||Odds Ratio (OR)|36.668|||<|0.0001|TWO_SIDED|97.5|5.717|235.193||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment,region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||235.193|5.717|<0.0001
71688697|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.74|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|90.0|2.45|5.02|||t-test, 2 sided|||FEV1/FVC Day 8 (0.25 hrs post-dose)||5.02|2.45|<0.0001
71855341|NCT01954771|143224613|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.801|||<|0.001|TWO_SIDED||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.||||<0.001
71855342|NCT04098497|143224646|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.74, df = 28||baseline to day 42 comparison||||0.09
71855343|NCT04098497|143224647|OTHER|||||||0.09|||||||t-test, 2 sided|t = 1.75, df = 28||baseline to day 42||||0.09
71855344|NCT04098497|143224648|SUPERIORITY|||||||0.13|||||||Regression, Linear|β = 0.14, z = 1.51||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.13
71855345|NCT04098497|143224649|SUPERIORITY|||||||0.007|||||||Regression, Linear|β = 0.38, z = 2.71||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.007
71855346|NCT04098497|143224650|SUPERIORITY|||||||0.57|||||||Regression, Linear|β = 0.03, z = 0.58||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.57
71855347|NCT04098497|143224651|SUPERIORITY|||||||0.25|||||||Regression, Linear|β = 0.06, z = 1.15||Mean difference between receiving the intervention and not receiving the intervention at each time point.||||0.25
71855348|NCT02864147|143224673|SUPERIORITY|||||||0.043||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.043
71855349|NCT02864147|143224673|SUPERIORITY|||||||0.384||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.384
71855350|NCT02864147|143224674|SUPERIORITY|||||||0.177||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.177
71855351|NCT02864147|143224674|SUPERIORITY|||||||0.592||||||Control is used as the referent using one-sided Fisher's exact tests with a multiple comparison-adjusted p\<0.025 significance level.|Fisher Exact|||||||0.592
71855352|NCT01350388|143224708|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
71905153|NCT03977727|143332061|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.029|TWO_SIDED|95.0|0.05|0.73|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.73|.05|.029
71905154|NCT03977727|143332062|SUPERIORITY||Mean Difference (Final Values)|-1.81||||0.016|TWO_SIDED|95.0|-2.84|-0.31|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||-0.31|-2.84|.016
71855353|NCT01350388|143224709|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANCOVA|||||||0.73
71855354|NCT01350388|143224710|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||||||0.23
71855355|NCT01350388|143224711|SUPERIORITY_OR_OTHER|||||||0.88|||||||ANCOVA|||||||0.88
71855356|NCT01350388|143224712|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
71855357|NCT01350388|143224713|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
71855358|NCT03640754|143224715|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71855359|NCT03640754|143224715|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71855360|NCT03640754|143224716|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71855361|NCT03640754|143224716|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71855362|NCT03640754|143224717|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71855363|NCT03640754|143224717|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71855364|NCT03640754|143224718|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|||||||0.199
71855365|NCT03640754|143224718|SUPERIORITY|||||||0.189|||||||t-test, 1 sided|||||||0.189
71855366|NCT03640754|143224719|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.398|||||||Mixed Models Analysis|||||||0.398
71855367|NCT03640754|143224719|SUPERIORITY|Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||||0.391|||||||Mixed Models Analysis|||||||0.391
71855368|NCT03640754|143224720|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.232
71855369|NCT03640754|143224720|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||Least squares means (LS Means) from a mixed effects repeated measures model with baseline M+S score, current smoking status, bmi, and parity as covariates||||0.085
71855370|NCT03640754|143224721|SUPERIORITY|||||||0.501|||||||Mixed Models Analysis|||||||0.501
71855371|NCT03640754|143224721|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.370
71855372|NCT03640754|143224722|SUPERIORITY|||||||0.333|||||||Mixed Models Analysis|||||||0.333
71855373|NCT03640754|143224722|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||0.014
71855374|NCT03640754|143224723|SUPERIORITY|||||||0.124|||||||Mixed Models Analysis|||||||0.124
71855375|NCT03640754|143224723|SUPERIORITY|||||||0.175|||||||Mixed Models Analysis|||||||0.175
71855376|NCT03640754|143224724|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
71855377|NCT03640754|143224724|SUPERIORITY|||||||0.077|||||||Mixed Models Analysis|||||||0.077
71680869|NCT02326298|142880354|SUPERIORITY||Odds Ratio (OR)|50.606|||<|0.0001|TWO_SIDED|97.5|7.88|324.988||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||324.988|7.880|<0.0001
71680870|NCT02326298|142880354|SUPERIORITY||Estimated difference in responder rate|35.4|||||TWO_SIDED|95.0|20.85|49.87|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||49.87|20.85|
71855378|NCT03640754|143224728|SUPERIORITY|||||||0.047|||||||t-test, 1 sided|||||||0.047
71855379|NCT03640754|143224728|SUPERIORITY|||||||0.139|||||||t-test, 1 sided|||||||0.139
71855380|NCT03640754|143224728|SUPERIORITY|||||||0.395|||||||t-test, 1 sided|||||||0.395
71855381|NCT03640754|143224729|SUPERIORITY|||||||0.147|||||||t-test, 1 sided|||||||0.147
71855382|NCT03640754|143224729|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|||||||0.160
71855383|NCT03640754|143224729|SUPERIORITY|||||||0.152|||||||t-test, 1 sided|||||||0.152
71855384|NCT03640754|143224730|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|||||||0.286
71855385|NCT03640754|143224730|SUPERIORITY|||||||0.107|||||||t-test, 1 sided|||||||0.107
71855386|NCT03640754|143224731|SUPERIORITY|||||||0.289|||||||t-test, 1 sided|||||||0.289
71855387|NCT03640754|143224731|SUPERIORITY|||||||0.338|||||||t-test, 1 sided|||||||0.338
71855388|NCT03640754|143224732|SUPERIORITY|||||||0.393|||||||t-test, 1 sided|||||||0.393
71855389|NCT03640754|143224732|SUPERIORITY|||||||0.365|||||||t-test, 1 sided|||||||0.365
71855390|NCT03640754|143224733|SUPERIORITY|||||||0.406|||||||t-test, 1 sided|||||||0.406
71855391|NCT03640754|143224733|SUPERIORITY|||||||0.494|||||||t-test, 1 sided|||||||0.494
71855392|NCT00663923|143224760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.1|<|0.05|TWO_SIDED|95.0|-0.62|-0.001||two - tailed p value \<0.05 were considered statistically significant.|t-test, 2 sided|in this study degrees of freedom is sample size - 1||||-.001|-.62|<0.05
71855393|NCT00230971|143224794|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.6||||||95.0|-6.4|9.6|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||9.6|-6.4|
71855394|NCT00230971|143224795|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.8||||0.001||95.0|-8.8|12.5|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|||12.5|-8.8|0.001
71855395|NCT00230971|143224796|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.7||||||95.0|-7.9|13.3|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|Group comparison of eradication + presumed eradication||13.3|-7.9|
71855396|NCT00230971|143224797|SUPERIORITY_OR_OTHER|||||||0.75|||||||ANOVA|Treatment as a factor||Overall inpatient hospitalization||||0.750
71855397|NCT00230971|143224797|SUPERIORITY_OR_OTHER|||||||0.655|||||||ANOVA|Treatment as a factor||Primary inpatient hospitalization||||0.655
71855398|NCT00230971|143224797|SUPERIORITY_OR_OTHER|||||||0.191|||||||ANOVA|Treatment as a factor||ICU treatment||||0.191
71855399|NCT00230971|143224797|SUPERIORITY_OR_OTHER|||||||0.717|||||||ANOVA|Treatment as a factor||Inpatient hospitalization, non-ICU||||0.717
71855400|NCT01772147|143224806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.089|0.164|||Mixed Models Analysis|||||0.164|0.089|<0.001
71855401|NCT01772147|143224806|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.148|||<|0.001|TWO_SIDED|95.0|0.111|0.185|||Mixed Models Analysis|||||0.185|0.111|<0.001
71855402|NCT03449134|143224820|OTHER||Estimated Percent Change Difference|-18.45||||0.041|TWO_SIDED|95.0|-32.92|-0.86||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||-0.86|-32.92|0.041
71855403|NCT03449134|143224820|OTHER||Estimated Percent Change Difference|1.56||||0.874|TWO_SIDED|95.0|-16.13|22.99||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||22.99|-16.13|0.874
71855404|NCT03449134|143224823|OTHER||Estimated Percent Change Difference|-17.68||||0.056|TWO_SIDED|95.0|-32.57|0.5||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||0.50|-32.57|0.056
71905155|NCT03977727|143332063|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.045|TWO_SIDED|95.0|0.04|2.32|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||2.32|.04|.045
71680871|NCT02326298|142880354|SUPERIORITY||Estimated difference in responder rate|43.1|||||TWO_SIDED|95.0|27.56|58.71|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.|Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||58.71|27.56|
71680872|NCT02326298|142880355|SUPERIORITY||Adjusted Mean Treatment Differences|-6.0|||<|0.0001|TWO_SIDED|97.5|-8.18|-3.81||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.81|-8.18|<0.0001
71680873|NCT02326298|142880355|SUPERIORITY||Ajusted Mean Treatment Differences|-6.84|||<|0.0001|TWO_SIDED|97.5|-9.05|-4.62||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.62|-9.05|<0.0001
71680874|NCT03191864|142880360|SUPERIORITY|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71680875|NCT03191864|142880360|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71680876|NCT03191864|142880360|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71680877|NCT03191864|142880360|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71680878|NCT03191864|142880362|OTHER||Mean Difference (Final Values)|-1.28||||0.02|TWO_SIDED|90.0|-2.29|-0.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.26|-2.29|0.020
71680879|NCT03191864|142880362|OTHER||Mean Difference (Final Values)|-2.08|||<|0.001|TWO_SIDED|90.0|-3.07|-1.1|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.10|-3.07|<0.001
71680880|NCT03191864|142880362|OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|90.0|-3.23|-1.26|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-1.26|-3.23|<0.001
71855405|NCT03449134|143224823|OTHER||Estimated Percent Change Difference|2.95||||0.77|TWO_SIDED|95.0|-15.33|25.19||Comparison based on a longitudinal ANCOVA model that included treatment, visit, treatment-by-visit interaction, gender, region, log-transformed baseline value, and log-transformed baseline value-by-visit as covariates.|ANCOVA|||Estimated relative reduction (ERR) relative to Placebo (i.e. estimated percent change difference) was calculated by 100 (e\*\*DIFF -1), where e = exponent of difference; and DIFF= treatment difference in change from baseline at Week 12 based on log transformed data.||25.19|-15.33|0.770
71680881|NCT03191864|142880362|OTHER||Mean Difference (Final Values)|-1.59||||0.005|TWO_SIDED|90.0|-2.59|-0.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparisons of each APT-1011 dose group to Placebo at Week 12 are from an ANCOVA model||-0.59|-2.59|0.005
71680882|NCT03191864|142880364|OTHER||Mean Difference (Final Values)|-1.19||||0.067|TWO_SIDED|90.0|-2.49|0.12|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||0.12|-2.49|0.067
71680883|NCT03191864|142880364|OTHER||Mean Difference (Final Values)|0.34||||0.672|TWO_SIDED|90.0|-0.91|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.91|0.672
71680884|NCT03191864|142880364|OTHER||Mean Difference (Final Values)|-1.28||||0.048|TWO_SIDED|90.0|-2.55|-0.01|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||-0.01|-2.55|0.048
71680885|NCT03191864|142880364|OTHER||Mean Difference (Final Values)|0.31||||0.653|TWO_SIDED|90.0|-0.98|1.59|||ANCOVA|||Least-squares Mean differences, 90% confidence intervals and 1-sided p-values for comparison of each APT-1011 dose group to placebo at Week 12 are from an ANCOVA model.||1.59|-0.98|0.653
71680886|NCT03191864|142880366|SUPERIORITY||Mean Difference (Final Values)|-8.81||||0.079|TWO_SIDED|90.0|-19.06|1.45|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||1.45|-19.06|0.079
71680887|NCT03191864|142880366|SUPERIORITY||Mean Difference (Final Values)|-5.18||||0.195|TWO_SIDED|90.0|-15.14|4.78|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||4.78|-15.14|0.195
71680888|NCT03191864|142880366|SUPERIORITY||Mean Difference (Final Values)|-12.56||||0.02|TWO_SIDED|90.0|-22.55|-2.58|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-2.58|-22.55|0.020
71680889|NCT03191864|142880366|SUPERIORITY||Mean Difference (Final Values)|-10.61||||0.043|TWO_SIDED|90.0|-20.74|-0.48|||ANCOVA|||EEsAI Total Score Change from Baseline Week 12||-0.48|-20.74|0.043
71855406|NCT03449134|143224824|OTHER||Odds Ratio (OR)|1.2||||0.416|TWO_SIDED|95.0|0.77|1.86|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.86|0.77|0.416
71855407|NCT03449134|143224824|OTHER||Odds Ratio (OR)|1.01||||0.948|TWO_SIDED|95.0|0.66|1.55|||Regression, Logistic|||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.55|0.66|0.948
71855408|NCT03449134|143224825|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.94|2.05||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.05|0.94|
71680890|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.459|TWO_SIDED|90.0|-3.49|3.08|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.08|-3.49|0.459
71680891|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|0.58||||0.617|TWO_SIDED|90.0|-2.65|3.8|||ANCOVA|||VDQ Score Change from Baseline Week 12||3.80|-2.65|0.617
71680892|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-1.87||||0.167|TWO_SIDED|90.0|-5.07|1.33|||ANCOVA|||VDQ Score Change from Baseline Week 12||1.33|-5.07|0.167
71855409|NCT03449134|143224825|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|1.01|2.18||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.18|1.01|
71855410|NCT03449134|143224826|OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.11|2.54||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.54|1.11|
71855411|NCT03449134|143224826|OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|1.01|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline CSD score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.01|
71855412|NCT03449134|143224827|OTHER||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|1.03|2.3||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.30|1.03|
71855413|NCT03449134|143224827|OTHER||Odds Ratio (OR)|1.27|||||TWO_SIDED|95.0|0.86|1.89||||||Comparison based on a logistic regression model that included treatment, visit, treatment-by-visit interaction, gender, region, baseline VAS score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.89|0.86|
71855414|NCT03449134|143224828|OTHER||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.85|1.98||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||1.98|0.85|
71855415|NCT03449134|143224828|OTHER||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.92|2.12||||||Comparison based on a logistic regression model that included visit, treatment-by-visit interaction, gender, region, baseline LCQ score, and the interaction of baseline (underlying continuous response) by visit as covariates.||2.12|0.92|
71855416|NCT01960348|143224842|SUPERIORITY||Least Squares Mean Difference|-33.99|STANDARD_ERROR_OF_MEAN|2.974|<|1e-07|TWO_SIDED|95.0|-39.86|-28.13||P=9.262E-24|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mNIS+7. The model includes baseline mNIS+7 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-28.13|-39.86|<0.0000001
71855417|NCT01960348|143224843|SUPERIORITY||Least Squares Mean Difference|-21.1|STANDARD_ERROR_OF_MEAN|3.1|<|1e-07|TWO_SIDED|95.0|-27.2|-15.0||P=1.103E-10|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in Norfolk QOL-DN total score. The model includes baseline Norfolk QOL-DN score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-15.0|-27.2|<0.0000001
71905156|NCT03977727|143332066|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.303|TWO_SIDED|95.0|-0.59|0.16|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||.16|-.59|.303
71905157|NCT03977727|143332067|SUPERIORITY||Mean Difference (Final Values)|-1.18||||0.968|TWO_SIDED|95.0|-10.32|9.99|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||9.99|-10.32|.968
71905158|NCT03977727|143332068|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.059|TWO_SIDED|95.0|-0.13|0.0|||Mixed Models Analysis|||Linear mixed model was fit with therapy (Fiasp vs. NovoLog), period (Period 1 vs Period 2), and sequence (Fiasp/NovoLog vs NovoLog/Fiasp) as fixed effects. Subjects included as random effects.||0|-.13|.059
71905159|NCT01627067|143332115|NON_INFERIORITY|The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months.|Cox Proportional Hazard|0.25||||0.015|TWO_SIDED|95.0|0.08|0.76|||Regression, Cox|||Data for PFS were censored at the time of a patient's removal from study. With 40 patients accrued at a rate of 2 patients per month, a one-sided alpha of 5%, and a post- accrual follow up of 3 months, we would have 80% power to detect a median PFS of 12 months as being statistically significantly higher than a historical control median PFS of 7 months. The study terminated early due to lack of efficacy and funds only 22 patients were enrolled in the study.||0.76|0.08|0.015
71905160|NCT01627067|143332118|OTHER||Hazard Ratio (HR)|0.6||||0.31|TWO_SIDED|95.0|0.22|1.62|||Regression, Cox|||||1.62|0.22|0.31
71905161|NCT00711269|143332119|SUPERIORITY|One-way Analysis of Variance (ANOVA)|LS Mean difference|-3.5||||0.149|TWO_SIDED|95.0|-8.4|1.3|||ANOVA||\[Not specified\]|||1.3|-8.4|0.149
71905162|NCT00711269|143332119|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.8||||0.462|TWO_SIDED|95.0|-6.6|3.0|||ANOVA|||||3.0|-6.6|0.462
71905163|NCT00711269|143332119|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-4.6||||0.122|TWO_SIDED|95.0|-10.5|1.2|||ANOVA|||||1.2|-10.5|0.122
71905164|NCT00711269|143332119|SUPERIORITY|Maximum Contrast Method||||||0.235||||||Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298|Maximum Contrast Method|Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145||||||0.235
71680893|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.373|TWO_SIDED|90.0|-3.88|2.61|||ANCOVA|||VDQ Score Change from Baseline Week 12||2.61|-3.88|0.373
71680894|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-1.66||||0.203|TWO_SIDED|90.0|-4.96|1.64|||ANCOVA|||AMS Score Change from Baseline Week 12||1.64|-4.96|0.203
71680895|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-4.33||||0.014|TWO_SIDED|90.0|-7.54|-1.13|||ANCOVA|||AMS Score Change from Baseline Week 12||-1.13|-7.54|0.014
71680896|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-3.02||||0.061|TWO_SIDED|90.0|-6.23|0.2|||ANCOVA|||AMS Score Change from Baseline Week 12||0.20|-6.23|0.061
71680897|NCT03191864|142880367|SUPERIORITY||Mean Difference (Final Values)|-2.57||||0.097|TWO_SIDED|90.0|-5.83|0.69|||ANCOVA|||AMS Score Change from Baseline Week 12||0.69|-5.83|0.097
71680898|NCT02086682|142880381|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||||||0.79
71680899|NCT01047332|142880393|OTHER|||||||0.53|||||||Log Rank|||||||0.530
71680900|NCT01047332|142880394|OTHER|||||||0.997|||||||Log Rank|||||||0.997
71680901|NCT03521817|142880399|OTHER||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|0.14|<|0.231|TWO_SIDED||||||t-test, 2 sided|||||||<0.231
71680902|NCT02417961|142880412|SUPERIORITY_OR_OTHER||Percentage|98.2||||||95.0|93.81|99.79|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)|||99.79|93.81|
71680903|NCT02417961|142880412|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)|||99.98|94.99|
71680904|NCT02417961|142880412|SUPERIORITY_OR_OTHER||Percentage|93.0|||||TWO_SIDED|95.0|86.64|96.92|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 and 16)|Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)|||96.92|86.64|
71680905|NCT02417961|142880413|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|95.21|99.98|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of patients returned functional APFS administered at home (Week 12)|||99.98|95.21|
71680906|NCT02417961|142880413|SUPERIORITY_OR_OTHER||Percentage|99.1|||||TWO_SIDED|95.0|94.99|99.98|||Clopper Pearson Exact CI|One sample confidence interval (Week 16)|Percentage of patients returned functional APFS administered at home (Week 16)|||99.98|94.99|
71855418|NCT01960348|143224844|SUPERIORITY||Least Squares Mean Difference|-17.87|STANDARD_ERROR_OF_MEAN|2.254|<|1e-07|TWO_SIDED|95.0|-22.32|-13.43||P=1.404E-13|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in NIS-W. The model includes baseline NIS-W score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-13.43|-22.32|<0.0000001
71905165|NCT00711269|143332120|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.069|TWO_SIDED|95.0|-2.9|0.1|||ANOVA|||||0.1|-2.9|0.069
71905166|NCT00711269|143332120|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.8||||0.287|TWO_SIDED|95.0|-2.3|0.7|||ANOVA|||||0.7|-2.3|0.287
71680907|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0)|Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)|||3.13|0.00|
71680908|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.9|||||TWO_SIDED|95.0|0.02|4.67|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 4)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)|||4.67|0.02|
71680909|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.16|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)|||3.16|0.00|
71855419|NCT01960348|143224845|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|1.01|<|1e-07|TWO_SIDED|95.0|7.0|10.9||P=4.066E-16|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in R-ODS value. The model includes baseline R-ODS score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||10.9|7.0|<0.0000001
71680910|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.13|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)|||3.13|0.00|
71680911|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|3.33|||Clopper-Pearson Exact CI|One sample Confidence Interval (Week 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)|||3.33|0|
71680912|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.3|||||TWO_SIDED|95.0|0.01|1.59|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 8)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)|||1.59|0.01|
71680913|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.0|||||TWO_SIDED|95.0|0.0|1.63|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 12 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)|||1.63|0.00|
71680914|NCT02417961|142880414|SUPERIORITY_OR_OTHER||Percentage|0.2|||||TWO_SIDED|95.0|0.0|0.97|||Clopper-pearson Exact CI|One sample Confidence Interval (Week 0 to 16)|Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)|||0.97|0.00|
71680915|NCT01632904|142880455|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.139|TWO_SIDED|95.0|0.82|4.04|||Chi-squared|||||4.04|0.82|0.139
71680916|NCT02059434|142880459|SUPERIORITY_OR_OTHER||Least squares mean difference|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.06|0.149||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.149|0.060|<0.0001
71905167|NCT00711269|143332120|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-2.3||||0.016|TWO_SIDED|95.0|-4.1|-0.4|||ANOVA|||||-0.4|-4.1|0.016
71905168|NCT00711269|143332121|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.289|TWO_SIDED|95.0|-2.0|0.6|||ANOVA|||||0.6|-2.0|0.289
71905169|NCT00711269|143332121|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.256|TWO_SIDED|95.0|-2.0|0.5|||ANOVA|||||0.5|-2.0|0.256
71905170|NCT00711269|143332121|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.352|TWO_SIDED|95.0|-2.3|0.8|||ANOVA|||||0.8|-2.3|0.352
71855420|NCT01960348|143224846|SUPERIORITY||Least Squares Mean Difference|0.311|STANDARD_ERROR_OF_MEAN|0.0415|<|1e-07|TWO_SIDED|95.0|0.23|0.393||P=1.875E-12|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in 10-meter walk test result. The model includes baseline 10-meter walk test result as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||0.393|0.230|<0.0000001
71855421|NCT01960348|143224847|SUPERIORITY||Least Squares Mean Difference|115.7|STANDARD_ERROR_OF_MEAN|16.91|<|1e-07|TWO_SIDED|95.0|82.4|149.0||P=8.832E-11|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mBMI. The model includes baseline mBMI as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||149.0|82.4|<0.0000001
71855422|NCT01960348|143224848|SUPERIORITY||Least Squares Mean Difference|-7.53|STANDARD_ERROR_OF_MEAN|2.213||0.0008|TWO_SIDED|95.0|-11.89|-3.16|||Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in COMPASS-31 total score. The model includes baseline COMPASS-31 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.||-3.16|-11.89|0.0008
71855423|NCT00275301|143224849|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.||||<0.05
71855424|NCT02097849|143224850|SUPERIORITY_OR_OTHER||Difference in proportion|-0.04||||0.692|TWO_SIDED|95.0|-0.27|0.19|||Clopper-Pearson Exact|||||0.19|-0.27|0.692
71855425|NCT02097849|143224851|SUPERIORITY_OR_OTHER||Difference in proportion|-0.19||||0.12|TWO_SIDED|95.0|-0.41|0.05|||Clopper-Pearson Exact|||Responders at Day 28||0.05|-0.41|0.120
71855426|NCT02097849|143224852|SUPERIORITY_OR_OTHER||Difference in proportions|-0.13||||0.225|TWO_SIDED|95.0|-0.35|0.1|||Clopper-Pearson Exact|||||0.10|-0.35|0.225
71855427|NCT02097849|143224853|SUPERIORITY_OR_OTHER||Difference in proportions|-0.22||||0.057|TWO_SIDED|95.0|-0.44|0.01|||Clopper-Pearson Exact|||||0.01|-0.44|0.057
71855428|NCT02097849|143224854|SUPERIORITY_OR_OTHER||Difference in proportions|0.07||||0.3|TWO_SIDED|95.0|-0.16|0.3|||Clopper-Pearson Exact|||||0.30|-0.16|0.300
71855429|NCT02097849|143224855|SUPERIORITY_OR_OTHER||Difference in proportions|-0.03||||0.714|TWO_SIDED|95.0|-0.26|0.2|||Clopper-Pearson Exact|||||0.20|-0.26|0.714
71855430|NCT02097849|143224856|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||0.967|TWO_SIDED|95.0|-0.24|0.23|||Clopper-Pearson Exact|||||0.23|-0.24|0.967
71905171|NCT00711269|143332122|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.251|TWO_SIDED|95.0|-3.9|1.0|||ANOVA|||||1.0|-3.9|0.251
71855431|NCT02097849|143224857|SUPERIORITY_OR_OTHER||Difference in proportions|-0.01||||0.955|TWO_SIDED|95.0|-0.24|0.22|||Clopper-Pearson Exact|||||0.22|-0.24|0.955
71855432|NCT01540162|143224866|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.23||||0.05|TWO_SIDED|95.0|0.05|0.73|||Chi-squared|||||0.73|0.05|0.05
71855433|NCT02561078|143224869|NON_INFERIORITY|The test for the primary objective of noninferiority was performed at the 0.05 significance level using the LS Mean estimate of the difference in change in HbA1c between the 2 treatments at Week 26. Noninferiority was established if the upper limit of a 2-sided 95% confidence interval (CI) for the difference (U 500R CSII minus U 500R MDI) was below the noninferiority margin (NIM) of 0.4%.|Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.62|-0.22|||Mixed Models Analysis|||||-0.22|-0.62|<0.001
71855434|NCT02561078|143224870|SUPERIORITY||Mean Difference (Net)|-35.6|||<|0.001|TWO_SIDED|95.0|-49.4|-21.7|||Mixed Models Analysis|||||-21.7|-49.4|<0.001
71855435|NCT02561078|143224871|SUPERIORITY||Odds Ratio (OR)|1.97||||0.015|TWO_SIDED|95.0|1.14|3.39|||Regression, Logistic|||||3.39|1.14|0.015
71855436|NCT02561078|143224872|SUPERIORITY||Odds Ratio (OR)|1.94||||0.005|TWO_SIDED|95.0|1.23|3.07|||Regression, Logistic|||||3.07|1.23|0.005
71855437|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|-22.5|||<|0.001|TWO_SIDED|95.0|-32.1|-12.8|||Mixed Models Analysis|||Pre Morning Meal||-12.8|-32.1|<0.001
71855438|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|-17.2||||0.008|TWO_SIDED|95.0|-29.9|-4.6|||Mixed Models Analysis|||2 Hours Post Morning Meal||-4.6|-29.9|0.008
71855439|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|-8.9||||0.138|TWO_SIDED|95.0|-20.6|2.9|||Mixed Models Analysis|||Pre Mid-Day Meal||2.9|-20.6|0.138
71855440|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|8.3||||0.16|TWO_SIDED|95.0|-3.3|19.8|||Mixed Models Analysis|||2 Hours Post Mid-Day Meal||19.8|-3.3|0.160
71855441|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|9.1||||0.113|TWO_SIDED|95.0|-2.2|20.4|||Mixed Models Analysis|||Pre Evening Meal||20.4|-2.2|0.113
71855442|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|16.7||||0.004|TWO_SIDED|95.0|5.3|28.2|||Mixed Models Analysis|||2 Hours Post Evening Meal||28.2|5.3|0.004
71855443|NCT02561078|143224873|SUPERIORITY||Mean Difference (Net)|0.6||||0.905|TWO_SIDED|95.0|-9.5|10.8|||Mixed Models Analysis|||Overnight (3:00 AM)||10.8|-9.5|0.905
71855444|NCT02561078|143224874|SUPERIORITY||Mean Difference (Net)|-48.4|||<|0.001|TWO_SIDED|95.0|-74.1|-22.8|||Mixed Models Analysis|||||-22.8|-74.1|<0.001
71855445|NCT02561078|143224875|SUPERIORITY||Odds Ratio (OR)|1.05||||0.919|TWO_SIDED|95.0|0.39|2.86|||Regression, Logistic|||||2.86|0.39|0.919
71855446|NCT02561078|143224876|SUPERIORITY||Relative Rate|1.21||||0.025|TWO_SIDED|95.0|1.02|1.42|||Negative binomial regression|||||1.42|1.02|0.025
71855447|NCT02561078|143224877|SUPERIORITY||Mean Difference (Net)|0.8||||0.1|TWO_SIDED|95.0|-0.2|1.8|||Mixed Models Analysis|||||1.8|-0.2|0.100
71855448|NCT01699698|143224898|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71905172|NCT00711269|143332122|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.2||||0.847|TWO_SIDED|95.0|-2.7|2.2|||ANOVA|||||2.2|-2.7|0.847
71905173|NCT00711269|143332122|SUPERIORITY|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.6||||0.292|TWO_SIDED|95.0|-4.6|1.4|||ANOVA|||||1.4|-4.6|0.292
71921939|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.7|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-11.7|6.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||6.2|-11.7|
71905174|NCT00926796|143332127|SUPERIORITY_OR_OTHER||Proportion of cured participants|100.0|||<|0.05|ONE_SIDED|95.0|98.53||||Exact binomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence limit is \>=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||98.53|<0.05
71905175|NCT00926796|143332134|SUPERIORITY_OR_OTHER||Proportion of cured participants|99.5|||<|0.05|ONE_SIDED|95.0|97.64||||Exact bionomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is \<95% is rejected.|When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly \>=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is \<95%.|||97.64|<0.05
71905176|NCT01628016|143332136|OTHER||Mean Difference (Final Values)|3.98||||0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||.05
71905177|NCT01341652|143332138|OTHER|||||||0.97|||||||Mantel Haenszel|||||||0.97
71905178|NCT01341652|143332139|SUPERIORITY|||||||0.08|||||||Wilcoxon Rank Sum test|||||||.08
71905179|NCT01341652|143332141|OTHER||Hazard Ratio (HR)|1.6||||0.14|TWO_SIDED|95.0|0.9|2.8|||Regression, Cox|||||2.8|0.9|0.14
71905180|NCT03483506|143332158|OTHER||Geometric mean ratio|8.34|STANDARD_DEVIATION|50.5|||TWO_SIDED|90.0|5.88|11.82|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||11.82|5.88|
71905181|NCT03483506|143332160|OTHER||Geometric mean ratio|62.14|STANDARD_DEVIATION|24.4|||TWO_SIDED|90.0|52.08|74.14|||ANOVA||"Standard deviation is actually intra individual geometric coefficient of variation. BI 1467335 tab arm is the numerator, while BI 1467335 (C-14) iv arm is the denominator."|The statistical model used for the analysis of the primary PK endpoints was an ANOVA (analysis of variance) model on the logarithmic scale. The model included effects accounting for 'subject' and 'formulation' as sources of variation; 'subject' was considered as a random effect, whereas 'formulation' was considered as a fixed effect.||74.14|52.08|
71905182|NCT04146467|143332191|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71905183|NCT04146467|143332193|SUPERIORITY||||||<|0.0004|||||||Fisher Exact|||||||<0.0004
71905184|NCT04146467|143332201|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71905185|NCT03259490|143332222|OTHER||Adjusted gmean ratio T/R (%)|103.06|STANDARD_DEVIATION|5.8|||TWO_SIDED|95.0|100.36|105.83|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.83|100.36|
71905186|NCT03259490|143332223|OTHER||Adjusted gmean ratio T/R (%)|100.35|STANDARD_DEVIATION|9.5|||TWO_SIDED|95.0|96.11|104.77|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.77|96.11|
71905187|NCT03259490|143332224|OTHER||Adjusted gmean ratio T/R (%)|100.31|STANDARD_DEVIATION|8.2|||TWO_SIDED|95.0|96.65|104.1|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.10|96.65|
71905188|NCT03259490|143332225|OTHER||Adjusted gmean ratio T/R (%)|99.95|STANDARD_DEVIATION|12.4|||TWO_SIDED|95.0|94.52|105.7|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.70|94.52|
71905189|NCT03259490|143332226|OTHER||Adjusted gmean ratio T/R (%)|107.78|STANDARD_DEVIATION|11.0|||TWO_SIDED|95.0|102.52|113.31|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||113.31|102.52|
71905190|NCT03259490|143332227|OTHER||Adjusted gmean ratio T/R (%)|97.17|STANDARD_DEVIATION|10.6|||TWO_SIDED|95.0|92.63|101.93|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||101.93|92.63|
71680917|NCT02059434|142880459|SUPERIORITY_OR_OTHER||Least squares mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.133|0.223||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates||0.223|0.133|<0.0001
71680918|NCT00771264|142880466|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.||Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p\<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher's exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.||||0.05
71680919|NCT02928770|142880471|OTHER|||||||0.0559|||||||t-test, 2 sided|Comparison between baseline and experimental (Nastent) conditions||||||0.0559
71680920|NCT01752634|142880503|SUPERIORITY||Odds Ratio (OR)|2.32||||0.02|TWO_SIDED|95.0|1.14|4.73|||Regression, Logistic|||||4.73|1.14|0.0200
71680921|NCT01752634|142880503|SUPERIORITY||Odds Ratio (OR)|6.52|||<|1|TWO_SIDED|95.0|3.25|13.08|||Regression, Logistic|||||13.08|3.25|<0001
71680922|NCT01752634|142880503|SUPERIORITY||Odds Ratio (OR)|6.81|||<|0.0001|TWO_SIDED|95.0|3.42|13.56|||Regression, Logistic|||||13.56|3.42|<.0001
71855449|NCT02151643|143224910|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).||||||0.784|||||||F-test|||"ITT population - statistical analysis of linear model fit using an F-test at the 0.05 level.~It was determined that 150 subjects randomised at a ratio of 8:8:8:13:13 (low dose to high dose, placebo) would have \>90% power to detect either a statistically significant slope for the dose-response relationship, or, if the relationship was not linear, a statistically significant difference between the highest-dose group and the placebo group, using a two-sided 0.05 significance level."||||0.784
71855450|NCT02151643|143224910|OTHER|Sensitivity analysis of ITT primary analysis using baseline observation carried forward (BOCF) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.905|||||||F-test|||"ITT population sensitivity analysis using baseline observation carried forward (BOCF) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.905
71680923|NCT01752634|142880504|SUPERIORITY||Odds Ratio (OR)|2.07||||0.165|TWO_SIDED|95.0|0.74|5.81|||Regression, Logistic|||||5.81|0.74|0.1650
71680924|NCT01752634|142880504|SUPERIORITY||Odds Ratio (OR)|5.7||||0.0006|TWO_SIDED|95.0|2.12|15.34|||Regression, Logistic|||||15.34|2.12|0.0006
71905191|NCT03259490|143332228|OTHER||Adjusted gmean ratio T/R (%)|103.11|STANDARD_DEVIATION|5.9|||TWO_SIDED|95.0|100.38|105.92|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||105.92|100.38|
71921940|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||0.9|-9.7|
71680925|NCT01752634|142880504|SUPERIORITY||Odds Ratio (OR)|9.48|||<|0.0001|TWO_SIDED|95.0|3.33|27.0|||Regression, Logistic|||||27.00|3.33|<.0001
71680926|NCT01752634|142880505|SUPERIORITY||Odds Ratio (OR)|1.38||||0.6421|TWO_SIDED|95.0|0.36|5.36|||Regression, Logistic|||||5.36|0.36|0.6421
71680927|NCT01752634|142880505|SUPERIORITY||Odds Ratio (OR)|6.36||||0.0029|TWO_SIDED|95.0|1.89|21.47|||Regression, Logistic|||||21.47|1.89|0.0029
71680928|NCT01752634|142880505|SUPERIORITY||Odds Ratio (OR)|10.74||||0.0002|TWO_SIDED|95.0|3.13|36.84|||Regression, Logistic|||||36.84|3.13|0.0002
71680929|NCT01752634|142880506|SUPERIORITY||Mean Difference (Net)|-0.16||||0.3763|TWO_SIDED|95.0|-0.53|0.2|||Mixed Models Analysis|||||0.20|-0.53|0.3763
71680930|NCT01752634|142880506|SUPERIORITY||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26|||Mixed Models Analysis|||||-0.26|-0.98|0.0008
71680931|NCT01752634|142880506|SUPERIORITY||Mean Difference (Net)|-0.65||||0.0004|TWO_SIDED|95.0|-1.02|-0.29|||Mixed Models Analysis|||||-0.29|-1.02|0.0004
71680932|NCT01752634|142880507|SUPERIORITY||Mean Difference (Net)|2.42||||0.0482|TWO_SIDED|95.0|0.02|4.83|||Mixed Models Analysis|||||4.83|0.02|0.0482
71680933|NCT01752634|142880507|SUPERIORITY||Mean Difference (Net)|4.44||||0.0003|TWO_SIDED|95.0|2.05|6.83|||Mixed Models Analysis|||||6.83|2.05|0.0003
71680934|NCT01752634|142880507|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.0001|TWO_SIDED|95.0|2.91|7.69|||Mixed Models Analysis|||||7.69|2.91|<0.0001
71680935|NCT01752634|142880508|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9195|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.9195
71680936|NCT01752634|142880508|SUPERIORITY||Mean Difference (Net)|-0.17||||0.0278|TWO_SIDED|95.0|-0.32|-0.02|||Mixed Models Analysis|||||-0.02|-0.32|0.0278
71680937|NCT01752634|142880508|SUPERIORITY||Mean Difference (Net)|-0.25||||0.0013|TWO_SIDED|95.0|-0.4|-0.1|||Mixed Models Analysis|||||-0.10|-0.40|0.0013
71680938|NCT01752634|142880509|SUPERIORITY||Odds Ratio (OR)|2.91||||0.0245|TWO_SIDED|95.0|1.15|7.36|||Regression, Logistic|||||7.36|1.15|0.0245
71680939|NCT01752634|142880509|SUPERIORITY||Odds Ratio (OR)|7.54|||<|0.0001|TWO_SIDED|95.0|3.11|18.25|||Regression, Logistic|||||18.25|3.11|<.0001
71680940|NCT01752634|142880509|SUPERIORITY||Odds Ratio (OR)|7.15|||<|0.0001|TWO_SIDED|95.0|2.97|17.22|||Regression, Logistic|||||17.22|2.97|<.0001
71855451|NCT02151643|143224910|OTHER|Sensitivity analysis of ITT primary analysis using multiple imputation (MI) for any missing Day 29 (Visit 11) serum phosphate values.||||||0.976|||||||F-test|||"ITT population sensitivity analysis using multiple imputation (MI) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.976
71855452|NCT02151643|143224910|OTHER|Sensitivity analysis of the primary ITT analysis using the Per Protocol (PP) population.||||||0.914|||||||F-test|||"Per protocol (PP) population sensitivity analysis to assess statistical analysis of linear model fit using an F-test at the 0.05 level."||||0.914
71855453|NCT02151643|143224910|OTHER|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (\< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject's last observed phosphate concentration value (Last Observation Carried Forward \[LOCF\] imputation).|Slope|-0.329|||<|0.001|TWO_SIDED||||||linear model - log (dose) - response|||ITT population - statistical analysis of the linear model log(PT20 dose)-response relationship to examine whether the linear trend of the change in phosphate level as a function of the log-transformed dose was statistically significant.||||<0.001
71855454|NCT02151643|143224910|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group||||<0.001
71855455|NCT02151643|143224910|OTHER|||||||0.436|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - visit||||0.436
71855456|NCT02151643|143224910|OTHER|||||||0.959|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group versus Visit interaction||||0.959
71855457|NCT02151643|143224910|OTHER||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration||||<0.001
71855458|NCT02151643|143224910|OTHER|||||||0.144|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration versus Visit interaction||||0.144
71855459|NCT02151643|143224910|OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.2847|||ONE_SIDED|97.5||0.761||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.761||
71855460|NCT02151643|143224910|OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.2881|||ONE_SIDED|97.5||0.659||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||0.659||
71855461|NCT02151643|143224910|OTHER||Mean Difference (Final Values)|-0.705|STANDARD_ERROR_OF_MEAN|0.2891|||ONE_SIDED|97.5||-0.05||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.05||
71680941|NCT01752634|142880510|SUPERIORITY||Odds Ratio (OR)|0.51||||0.3149|TWO_SIDED|95.0|0.13|1.91|||Regression, Logistic|||||1.91|0.13|0.3149
71855462|NCT02151643|143224910|OTHER||Mean Difference (Final Values)|-1.195|STANDARD_ERROR_OF_MEAN|0.255|||ONE_SIDED|97.5||-0.618||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration||-0.618||
71855463|NCT02151643|143224911|OTHER|||||||0.497|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by PT20 dose group.||||0.497
71855464|NCT02151643|143224911|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by baseline hemoglobin.||||<0.001
71855465|NCT02151643|143224912|OTHER|||||||0.243|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by PT20 dose group.||||0.243
71855466|NCT02151643|143224912|OTHER|||||||0.867|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by Visit.||||0.867
71855467|NCT02151643|143224912|OTHER|||||||0.186|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration||||0.186
71855468|NCT02151643|143224913|OTHER|||||||0.068|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by PT20 dose group.||||0.068
71855469|NCT02151643|143224913|OTHER|||||||0.013|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Visit.||||0.013
71855470|NCT02151643|143224913|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation.||||<0.001
71855471|NCT02151643|143224914|OTHER|||||||0.004|||||||ANCOVA|||Repeated measures ANCOVA for change in Calcium x Phosphate Product from Baseline by PT20 dose group.||||0.004
71855472|NCT02151643|143224914|OTHER||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Calcium x Phosphate Product.||||<0.001
71855473|NCT02151643|143224915|OTHER|||||||0.292|||||||paired z-test|||||||0.292
71855474|NCT02151643|143224915|OTHER|||||||0.047|||||||paired z-test|||||||0.047
71855475|NCT02151643|143224915|OTHER|||||||0.872|||||||paired z-test|||||||0.872
71855476|NCT02151643|143224915|OTHER|||||||0.288|||||||paired z-test|||||||0.288
71855477|NCT03619889|143224916|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71855478|NCT03619889|143224916|OTHER||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71855479|NCT03619889|143224923|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71855480|NCT03619889|143224923|OTHER||Mean Difference (Net)|-0.65|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71855481|NCT01084239|143224949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|Result for index hospitalization||||||<0.001
71855482|NCT03924947|143224968|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|Least Squares (LS) Mean of Difference|0.94|STANDARD_ERROR_OF_MEAN|1.176|||TWO_SIDED|99.0|-2.37|4.259|||||LS mean (standard error \[SE\]) and LS mean confidence interval (CI) are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon MP||4.259|-2.370|
71855483|NCT03924947|143224969|OTHER|Descriptive|LS Mean of Difference|-0.03|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|95.0|-2.456|2.392|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||2.392|-2.456|
71855484|NCT03924947|143224969|OTHER|Descriptive|LS Mean of Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.035|||TWO_SIDED|95.0|-3.005|1.345|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon AAPIS||1.345|-3.005|
71855485|NCT03924947|143224970|OTHER|Descriptive|LS Mean of Difference|-3.36|STANDARD_ERROR_OF_MEAN|3.541|||TWO_SIDED|95.0|-10.699|3.987|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||3.987|-10.699|
71855486|NCT03924947|143224970|OTHER|Descriptive|LS Mean of Difference|3.27|STANDARD_ERROR_OF_MEAN|4.016|||TWO_SIDED|95.0|-5.172|11.702|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||11.702|-5.172|
71855487|NCT03924947|143224971|OTHER|Descriptive|LS Mean of Difference|34.68|STANDARD_ERROR_OF_MEAN|62.253|||TWO_SIDED|95.0|-94.424|163.786|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Creon - Creon MP||163.786|-94.424|
71680942|NCT01752634|142880510|SUPERIORITY||Odds Ratio (OR)|0.16||||0.0056|TWO_SIDED|95.0|0.04|0.58|||Regression, Logistic|||||0.58|0.04|0.0056
71855488|NCT03924947|143224971|OTHER|Descriptive|LS Mean of Difference|-16.56|STANDARD_ERROR_OF_MEAN|60.858|||TWO_SIDED|95.0|-144.418|111.298|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|DB Creon - DB Creon AAPIS||111.298|-144.418|
71855489|NCT03924947|143224972|NON_INFERIORITY|The pre-specified non-inferiority margin of upper bound of the two-sided 99% confidence interval for the treatment difference was 12%.|LS Mean of Difference|-1.15|STANDARD_ERROR_OF_MEAN|1.302|||TWO_SIDED|99.0|-4.892|2.602|||||LS mean (SE) and LS mean CI are based on a mixed effects model including sequence, period and regimen as fixed effects and participants within sequence as a random effect.|Double Blind Creon - Double Blind Creon AAPIS||2.602|-4.892|
71855490|NCT01797822|143224982|OTHER|Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P\<0.05) in change in corneal staining pre and post low humidity challenge.|||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71855491|NCT02853305|143225060|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0033|TWO_SIDED|95.0|0.65|0.93|||Stratified Log-Rank|The treatment difference in PFS was assessed by the stratified log-rank test.||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the chemo arm to address the first primary hypothesis (superiority to chemo). The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||0.93|0.65|0.0033
71855492|NCT02853305|143225061|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0407|TWO_SIDED|95.0|0.72|1.02|||Stratified Log-Rank|The treatment difference in OS was assessed by the stratified log-rank test.||OS in all participants of the pembro combo arm was compared to OS in all participants of the chemo arm to address the second primary hypothesis (superiority to chemo). The HR and its 95% CI were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.02|0.72|0.0407
71905192|NCT03259490|143332229|OTHER||Adjusted gmean ratio T/R (%)|100.17|STANDARD_DEVIATION|10.1|||TWO_SIDED|95.0|95.68|104.86|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||104.86|95.68|
71905193|NCT03259490|143332230|OTHER||Adjusted gmean ratio T/R (%)|97.3|STANDARD_DEVIATION|13.2|||TWO_SIDED|95.0|91.65|103.29|||ANOVA|Analysis of Variance (ANOVA) on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.||103.29|91.65|
71905194|NCT01963208|143332231|OTHER||Median Difference (Final Values)|-7.06||||0.1788|TWO_SIDED|95.0|-17.44|3.52||The null hypothesis is that there is no difference between the distributions of the two treatment groups with respect to percent change in seizure frequency.|Rank ANCOVA|||||3.52|-17.44|0.1788
71905195|NCT00798694|143332351|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months."||||0.005
71680943|NCT01752634|142880510|SUPERIORITY||Odds Ratio (OR)|0.14||||0.0021|TWO_SIDED|95.0|0.04|0.5|||Regression, Logistic|||||0.50|0.04|0.0021
71855493|NCT02853305|143225062|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.77|1.32||No formal hypothesis testing was performed.||||OS in CPS≥10 participants of the pembro arm was compared to OS in CPS≥10 participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) at baseline.||1.32|0.77|
71905196|NCT03546413|143332360|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Regression, Logistic|||Test for equivalence between the groups||||<0.001
71905197|NCT03546413|143332361|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.055|||||||Regression, Logistic|||Test for equivalence between the groups||||0.055
71905198|NCT03546413|143332362|SUPERIORITY||||||<|0.001||||||This is the calculated p-value|Wilcoxon (Mann-Whitney)|||||||<0.001
71855494|NCT02853305|143225063|OTHER||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.77|1.11||No formal hypothesis testing was performed.||||OS in all participants of the pembro arm was compared to OS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.11|0.77|
71905199|NCT03546413|143332362|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.|||||<|0.001||||||This is the calculated p-value|Regression, Linear|||||||<0.001
71855495|NCT02853305|143225064|OTHER||Hazard Ratio (HR)|1.32|||||TWO_SIDED|95.0|1.09|1.58||No formal hypothesis testing was performed.||||PFS in all participants of the pembro arm was compared to PFS in all participants of the chemo arm. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.58|1.09|
71905200|NCT03546413|143332362|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.939|||||||Regression, Linear|||||||0.939
71905201|NCT03546413|143332362|SUPERIORITY|A linear regression model was used on the log of the peanut consumption with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.002|||||||Regression, Linear|||||||0.002
71905202|NCT03546413|143332363|SUPERIORITY|||||||0.131|||||||Wilcoxon (Mann-Whitney)|||||||0.131
71905203|NCT03546413|143332363|SUPERIORITY|A linear regression model was used on the log of peanut skin prick test with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.208|||||||Regression, Linear|||||||0.208
71680944|NCT01752634|142880511|SUPERIORITY||Odds Ratio (OR)|0.58||||0.1678|TWO_SIDED|95.0|0.26|1.26|||Regression, Logistic|||||1.26|0.26|0.1678
71855496|NCT02853305|143225067|OTHER||Difference in Percentage|9.8|||||TWO_SIDED|95.0|2.4|17.1||No formal hypothesis testing was performed.||||ORR in participants of the pembro combo arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||17.1|2.4|
71855497|NCT02853305|143225069|OTHER||Difference in Percentage|4.5|||||TWO_SIDED|95.0|-1.6|10.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro combo arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||10.6|-1.6|
71855498|NCT02853305|143225070|SUPERIORITY||Difference in Percentage|-14.8|||||TWO_SIDED|95.0|-22.0|-7.4||No formal hypothesis testing was performed.||||ORR in participants of the pembro arm was compared to ORR in participants of the chemo arm. The comparison was based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-7.4|-22.0|
71855499|NCT02853305|143225072|OTHER||Difference in Percentage|-28.9|||||TWO_SIDED|95.0|-35.9|-21.6||No formal hypothesis testing was performed.||||DCR in participants of the pembro arm was compared to DCR in participants of the chemo arm based on the Miettinen \& Nurminen method stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||-21.6|-35.9|
71905204|NCT03546413|143332363|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.587|||||||Regression, Linear|||||||0.587
71905205|NCT03546413|143332363|SUPERIORITY|A linear regression model was used on the log of peanut skin prick with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.268|||||||Regression, Linear|||||||0.268
71905206|NCT03546413|143332364|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
71905207|NCT03546413|143332364|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.371|||||||Regression, Linear|||||||0.371
71905208|NCT03546413|143332364|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.483|||||||Regression, Linear|||||||0.483
71680945|NCT01752634|142880511|SUPERIORITY||Odds Ratio (OR)|0.36||||0.0108|TWO_SIDED|95.0|0.17|0.79|||Regression, Logistic|||||0.79|0.17|0.0108
71680946|NCT01752634|142880511|SUPERIORITY||Odds Ratio (OR)|0.29||||0.0025|TWO_SIDED|95.0|0.13|0.65|||Regression, Logistic|||||0.65|0.13|0.0025
71905209|NCT03546413|143332364|SUPERIORITY|A linear regression model was used on the log of peanut specific IgE with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.643|||||||Regression, Linear|||||||0.643
71905210|NCT03546413|143332365|SUPERIORITY|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
71905211|NCT03546413|143332365|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.857|||||||Regression, Linear|||||||0.857
71905212|NCT03546413|143332365|SUPERIORITY|A linear regression model was used on the log of SCORAD with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.87|||||||Regression, Linear|||||||0.870
71905213|NCT03546413|143332366|SUPERIORITY|||||||0.658|||||||Regression, Logistic|||||||0.658
71905214|NCT03546413|143332366|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.1|||||||Regression, Logistic|||||||0.100
71905215|NCT03546413|143332366|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Linear|||||||0.502
71680947|NCT01911780|142880581|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-7.5|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.7|-5.3|||LOCF-ANCOVA|Last observation carried forward (LOCF) was used as the imputation method|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.|||-5.3|-9.7|<0.0001
71855500|NCT02853305|143225076|OTHER||Difference in LS Means|2.68|||||TWO_SIDED|95.0|-0.76|6.12||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||6.12|-0.76|
71855501|NCT02853305|143225077|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.62|1.0||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.00|0.62|
71855502|NCT02853305|143225078|OTHER||Difference in LS Means|-0.94|||||TWO_SIDED|95.0|-5.06|3.18||No formal hypothesis testing was performed.||||Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on cLDA model with GHS/QoL score as response variable, and with treatment by study visit interactions and stratification factors (investigator's choice of chemotherapy \[cisplatin or carboplatin\] and PD-L1 status \[CPS\<10 vs. CPS≥10\]) at baseline as covariates.||3.18|-5.06|
71855503|NCT02853305|143225079|OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.93|1.49||No formal hypothesis testing was performed.||||TTD in GHS/QoL combined score was compared between all participants of the pembro arm and the chemo arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by investigator's choice of chemotherapy (cisplatin or carboplatin) and PD-L1 status (CPS\<10 vs. CPS≥10) at baseline.||1.49|0.93|
71855504|NCT02381652|143225082|OTHER|Statistical test to see if there is a difference||||||0.3108|||||||Fisher Exact|||||||0.3108
71855505|NCT01340300|143225083|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||<0.0001
71855506|NCT01340300|143225083|SUPERIORITY|||||||0.003||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.003
71855507|NCT01340300|143225083|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.||||0.01
71855508|NCT01340300|143225083|SUPERIORITY|||||||0.03||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.||||0.03
71855509|NCT01340300|143225084|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.||||0.0002
71855510|NCT01340300|143225084|SUPERIORITY|||||||0.002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.002
71855511|NCT01340300|143225084|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP\_1 in treatment arm is greater than the control arm.||||0.02
71855512|NCT01340300|143225084|SUPERIORITY|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.0002
71680948|NCT01911780|142880582|SUPERIORITY_OR_OTHER||Adjusted mean, comparison|-8.6|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-12.7|-4.5||Additional information, the p-value is not adjusted for multiplicity.|LOCF-ANCOVA||Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.|||-4.5|-12.7|<0.0001
71905216|NCT03546413|143332366|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.397|||||||Regression, Linear|||||||0.397
71905217|NCT03546413|143332367|SUPERIORITY|||||||0.659|||||||Regression, Logistic|||||||0.659
71855513|NCT01340300|143225084|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.||||0.02
71855514|NCT01340300|143225085|SUPERIORITY|||||||0.0004||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.0004
71855515|NCT01340300|143225085|SUPERIORITY|||||||0.007||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.||||0.007
71855516|NCT01340300|143225086|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
71855517|NCT01340300|143225086|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||<0.0001
71855518|NCT01340300|143225086|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.||||0.01
71855519|NCT01340300|143225087|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
71855520|NCT01340300|143225087|SUPERIORITY||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||<0.0001
71855521|NCT01340300|143225087|SUPERIORITY|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.||||0.02
71855522|NCT01340300|143225088|SUPERIORITY|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (\< 30 or \> 30), gender, cancer, and study site.||Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.||||0.01
71855523|NCT03544229|143225089|SUPERIORITY||Least Square Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.25|=|0.618|TWO_SIDED|90.0|-0.34|0.49||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.49|-0.34|=0.618
71905218|NCT03546413|143332367|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.26|||||||Regression, Logistic|||||||0.260
71905219|NCT03546413|143332367|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.075|||||||Regression, Linear|||||||0.075
71905220|NCT03546413|143332367|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.192|||||||Regression, Logistic|||||||0.192
71905221|NCT03546413|143332368|SUPERIORITY|||||||0.729|||||||Regression, Logistic|||||||0.729
71905222|NCT03546413|143332368|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.75|||||||Regression, Logistic|||||||0.750
71905223|NCT03546413|143332368|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.155|||||||Regression, Logistic|||||||0.155
71905224|NCT03546413|143332368|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.||||||0.458|||||||Regression, Logistic|||||||0.458
71905225|NCT03546413|143332369|SUPERIORITY|||||||0.33|||||||Regression, Logistic|||||||0.330
71905226|NCT03546413|143332369|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.351|||||||Regression, Logistic|||||||0.351
71905227|NCT03546413|143332369|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.502|||||||Regression, Logistic|||||||0.502
71905228|NCT03546413|143332369|SUPERIORITY|||||||0.732||||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit.|Regression, Logistic|||||||0.732
71905229|NCT03546413|143332370|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.202|||||||Regression, Logistic|||||||0.202
71905230|NCT03546413|143332370|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in older siblings.|||
71905231|NCT03546413|143332370|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for parents who are in the same family unit. However, the logistic regression model was unable to converge due to the low percentage of allergic participants in parents.|||
71905232|NCT03546413|143332371|SUPERIORITY|||||||0.029|||||||Regression, Logistic|||||||0.029
71905233|NCT03546413|143332371|SUPERIORITY|A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit.||||||0.489|||||||Regression, Logistic|||||||0.489
71905234|NCT03546413|143332371|OTHER||||||||||||||Regression, Logistic||||A logistic regression model was used with a fixed effect comparing the Avoidance and Consumption cohorts and a random effect to account for siblings who are in the same family unit. However, the model was unable to converge due to the low percentage of peanut-related adverse events in older siblings.|||
71905235|NCT01089582|143332383|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.||||0.0023
71905236|NCT01089582|143332384|SUPERIORITY_OR_OTHER|||||||0.0382|TWO_SIDED||||||Regression, Logistic|||The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.||||0.0382
71905237|NCT01089582|143332385|SUPERIORITY_OR_OTHER|||||||0.1805|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.1805
71905238|NCT01089582|143332385|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.||||<0.0001
71905239|NCT01089582|143332385|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
71905240|NCT01089582|143332386|SUPERIORITY_OR_OTHER|||||||0.0137|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.||||0.0137
71905241|NCT01089582|143332386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.||||<0.0001
71905242|NCT01089582|143332386|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.||||<0.0001
71905243|NCT00862849|143332390|SUPERIORITY_OR_OTHER||LS Mean Difference|26.47|||<|0.0001|TWO_SIDED|90.0|18.22|34.71||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.||||34.71|18.22|<0.0001
71905244|NCT00862849|143332390|SUPERIORITY_OR_OTHER||LS Mean Difference|16.7||||0.0015|TWO_SIDED|90.0|8.45|24.94||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed||||24.94|8.45|0.0015
71905245|NCT01102218|143332397|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71905246|NCT02841787|143332436|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||< .001
71905247|NCT02841787|143332436|SUPERIORITY||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||<.001
71905248|NCT02841787|143332436|SUPERIORITY|||||||0.44||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.44
71905249|NCT02841787|143332436|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|ANOVA|||||||0.03
71905250|NCT02841787|143332436|SUPERIORITY|||||||0.68||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.68
71905251|NCT02841787|143332436|SUPERIORITY|||||||0.02||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.02
71905252|NCT02841787|143332436|SUPERIORITY|||||||0.03||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.03
71855524|NCT03544229|143225089|SUPERIORITY||Least Square Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17|=|0.533|TWO_SIDED|90.0|-0.27|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.27|=0.533
71855525|NCT03544229|143225089|SUPERIORITY||Least Square Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.167|=|0.447|TWO_SIDED|90.0|-0.3|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD composite score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.30|=0.447
71855526|NCT03544229|143225090|SUPERIORITY||Odds Ratio (OR)|0.87|||=|0.607|TWO_SIDED|90.0|0.39|1.96|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.96|0.39|=0.607
71905253|NCT02841787|143332439|SUPERIORITY|||||||0.003||||||The threshold for significance was alpha=0.05.|t-test, 2 sided|||||||0.003
71905254|NCT02724774|143332595|SUPERIORITY|||||||0.026||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||All analyses were conducted as intention-to-treat, analyzing all 252 cases as randomly assigned to the PFR and control group (CG). Multiple linear regression was used to examine the treatment effect of PFR (0 = CG, 1 = PFR). Covariates included preferred language (0 = English, 1 = Spanish) and the baseline measure.||||.026
71905255|NCT02724774|143332596|SUPERIORITY|||||||0.154||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.154
71905256|NCT02724774|143332597|SUPERIORITY|||||||0.516||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.516
71905257|NCT02724774|143332598|SUPERIORITY||||||<|0.001||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||<0.001
71905258|NCT02724774|143332599|SUPERIORITY|||||||0.094||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||0.094
71855527|NCT03544229|143225090|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.283|TWO_SIDED|90.0|0.7|2.1|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||2.10|0.70|=0.283
71905259|NCT02724774|143332600|SUPERIORITY|||||||0.029|||||||Regression, Linear|||||||0.029
71905260|NCT02724774|143332601|SUPERIORITY|||||||0.389||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.389
71905261|NCT02724774|143332602|SUPERIORITY|||||||0.747||||||a priori threshold for statistical significance p \< .05|Regression, Linear|||||||.747
71905262|NCT02951988|143332633|SUPERIORITY|||||||0.5305|||||||Log Rank|||||||0.5305
71905263|NCT02951988|143332633|SUPERIORITY|||||||0.4628|||||||Log Rank|||||||0.4628
71905264|NCT02951988|143332634|SUPERIORITY|||||||0.6153|||||||Log Rank|||||||0.6153
71905265|NCT02951988|143332634|SUPERIORITY|||||||0.4123|||||||Log Rank|||||||0.4123
71905266|NCT05836818|143332636|SUPERIORITY||Adjusted difference|25.1|||<|0.0001|TWO_SIDED|95.0|17.0|33.2|||Regression, Logistic|Mixed effects logistic regression with a random center effect for within-center characteristics, and terms for calendar time and intervention||Adjusted difference 25.1 percentage points||33.2|17|<0.0001
71905267|NCT00621855|143332682|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
71905268|NCT00621855|143332685|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"||||<0.001
71905269|NCT00403559|143332689|NON_INFERIORITY|Non-inferiority determined as the F-IGA, IGA, erythema, scaling, and pruritis scores when compared between groups. The Wilcoxon rank sum test stratified baseline seborrheic dermatitis (SD) severity.||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||.009
71905270|NCT00929734|143332706|SUPERIORITY_OR_OTHER|||||||0.292|TWO_SIDED||||||ANCOVA|||||||0.292
71905271|NCT00929734|143332707|SUPERIORITY_OR_OTHER|||||||0.462|TWO_SIDED||||||ANCOVA|||||||0.462
71905272|NCT00929734|143332708|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)|ANCOVA|||||||0.017
71905273|NCT00929734|143332709|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||ANCOVA with natural logarithm of interleukin 6 (ln IL6)|ANCOVA|||||||0.028
71905274|NCT00980980|143332720|SUPERIORITY_OR_OTHER|||||||0.01|||||||Proportional-hazards models|Proportional-hazards models with shared frailties accounted for clustering within hospitals.||||||0.01
71905275|NCT00414960|143332741|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.04||0.556|TWO_SIDED|95.0|-10.64|5.83||P-value is for comparison of change from baseline between enzastaurin and placebo group.|2-sample pooled t-test||Using placebo as a reference group, the mean difference = enzastaurin minus placebo.|||5.83|-10.64|0.556
71905276|NCT04633473|143332762|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.922
71905277|NCT04633473|143332763|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.521|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.521
71905278|NCT04633473|143332764|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.678|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.678
71905279|NCT04633473|143332765|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.326|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.326
71905280|NCT04633473|143332766|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.09|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.09
71905281|NCT04633473|143332767|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.154|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.154
71905282|NCT04633473|143332768|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.309|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.309
71905283|NCT04633473|143332770|SUPERIORITY||Mean Difference (Final Values)|0.26||||0.181|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.181
71905284|NCT04633473|143332771|SUPERIORITY||Mean Difference (Final Values)|0.91||||0.008|TWO_SIDED||||||t-test, 2 sided|Within subjects paired t-tests.||||||0.008
71905285|NCT05291949|143332774|OTHER|Bland-Altman|Bias|0.3|||||TWO_SIDED||||||Bland-Altman||||Lower 95% Limit of agreement (LoA) value = -0.34 Upper 95% LoA = 0.94|||
71905286|NCT01029886|143332832|NON_INFERIORITY_OR_EQUIVALENCE|Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was \<0.25%.|Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|0.08|0.33|||Mixed Models Analysis|||A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.33|0.08|0.002
71905287|NCT01029886|143332833|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.||||0.011
71855528|NCT03544229|143225090|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.527|TWO_SIDED|90.0|0.56|1.69|||Logistic Regression||Comparisons of TAK-906 to Placebo was based on logistic regression with at least 50% reduction of participants from baseline in weekly composite score with baseline composite score, disease population at randomization, and treatment as covariates.|||1.69|0.56|=0.527
71905288|NCT01029886|143332834|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.15||0.021|TWO_SIDED|95.0|0.05|0.66|||Mixed Models Analysis|||MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.66|0.05|0.021
71905289|NCT01029886|143332835|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.39|1.4|||Mixed Models Analysis|||MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.40|0.39|<.001
71905290|NCT01029886|143332836|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.05||0.079|TWO_SIDED|95.0|-0.01|0.19|||Mixed Models Analysis|||MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.19|-0.01|0.079
71905291|NCT01029886|143332837|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.832|TWO_SIDED|95.0|-0.02|0.02|||Mixed Models Analysis|||MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.02|-0.02|0.832
71905292|NCT01029886|143332838|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|1.04|1.15|||Mixed Models Analysis|||Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||1.15|1.04|<.001
71905293|NCT01029886|143332839|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.76||0.205|TWO_SIDED|95.0|-0.53|2.47|||Mixed Models Analysis|||MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||2.47|-0.53|0.205
71905294|NCT01029886|143332840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.981|TWO_SIDED|95.0|-0.96|0.98|||Mixed Models Analysis|||MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.||0.98|-0.96|0.981
71905295|NCT00242385|143332864|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-35d divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.928|||||TWO_SIDED|90.0|0.858|1.002||||||||1.002|0.858|
71905296|NCT00242385|143332865|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To establish bioequivalence in AUC 0-infinity divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.934|||||TWO_SIDED|90.0|0.855|1.021||||||||1.021|0.855|
71905297|NCT04348591|143332876|SUPERIORITY||Mean Difference (Final Values)|-0.046|STANDARD_ERROR_OF_MEAN|0.037||0.221|TWO_SIDED|95.0|-0.12|0.029||This p value corresponds to the main effect for experimental group; a-priori threshold was .012|Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined main effects of experimental group, instruction provided, headache, racial background, and type of neurostimulation administered. HF-HRV was transformed using an lg function for normality.||.029|-.12|.221
71905298|NCT04348591|143332876|SUPERIORITY|This is a within subject analysis that uses data across groups, controlling for the effect of neurostimulation alone, coil to cortex distance, and racial background|Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.008|TWO_SIDED|95.0|0.016|0.103|||Mixed Models Analysis|Comparison between sham neurostimulation and high frequency neurostimulation||A MMANOVA analysis using an unstructured covariance examined the main effect of type of neurostimulation provided||.103|.016|.008
71905299|NCT04348591|143332876|SUPERIORITY|The analysis controls for coil to cortex distance, racial background and effect of neurostimulation alone. It compares sham stimulation with low frequency neurostimulation|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.021||0.001|TWO_SIDED|95.0|0.029|0.111|||Mixed Models Analysis|||A MMANOVA analysis using an unstructured covariance structure examined the main effect of type of neurostimulation provided.||.111|.029|.001
71905300|NCT04348591|143332877|SUPERIORITY||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.232||0.34|TWO_SIDED|95.0|-0.243|0.689|||Mixed Models Analysis||This is the result for the main effect found of group (emotion dysregulation group versus misophonia)|A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.689|-.243|.34
71905301|NCT04348591|143332877|SUPERIORITY||Mean Difference (Final Values)|0.493|STANDARD_ERROR_OF_MEAN|0.148||0.001|TWO_SIDED|95.0|0.198|0.787|||Mixed Models Analysis|This is the main effect of neurostimulation condition. Specifically here we show the difference in estimated marginal means between sham and HF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.787|.198|.001
71905302|NCT04348591|143332877|SUPERIORITY||Mean Difference (Final Values)|0.469|STANDARD_ERROR_OF_MEAN|0.144||0.002|TWO_SIDED|95.0|0.182|0.757|||Mixed Models Analysis|This is the main effect of neurostimulation administered, specifically comparing estimated marginal means for sham and LF-rTMS||A MMANOVA analysis using an unstructured covariance structure examined changes in SCL between groups, experimental types of neurostimulation, and their interaction, controlling for baseline, racial background, coil to cortex distance, and headache||.757|.182|.002
71905303|NCT04348591|143332877|SUPERIORITY||Mean Difference (Final Values)|0.73||||0.0005|TWO_SIDED||||||Mixed Models Analysis||mean difference between sham and HF-rTMS for misophonia participants only when downregulating misophonic sounds|The investigators tested the interaction between experimental neurostimulation (sham, active high frequency rTMS, active low frequency rTMS), instruction provided (listen to neutral sound; listen to aversive sound, listen to misophonic sound, downregulate aversive sound, downregulate misophonic sound), and group (misophonic, clinical control) as part of the same MMANOVA analysis described above (i.e., controlling for coil-to-cortex distance, racial background, baseline, \& presence of headache).||||.0005
71905304|NCT04348591|143332879|SUPERIORITY||Mean Difference (Final Values)|0.0563|STANDARD_ERROR_OF_MEAN|0.09853||0.57|TWO_SIDED|95.0|-0.14149|0.25411|||t-test, 2 sided|||An independent samples t-test was conducted to examine differences between groups in BOLD bilateral dlPFC signal during the regulation of misophonic versus aversive sounds. One outlier was removed from the misophonia group to avoid violating the normality assumption.||.25411|-.14149|.57
71680949|NCT01911780|142880583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.0052|TWO_SIDED|95.0|1.4|7.1||Additional information, the p-value is not adjusted for multiplicity.|Regression, Logistic|Non-completers considered failures (NCF) was used as the imputation method.|Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.|||7.1|1.4|0.0052
71855529|NCT03544229|143225091|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.279|=|0.584|TWO_SIDED|90.0|-0.4|0.52||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.52|-0.40|=0.584
71905305|NCT04348591|143332880|SUPERIORITY||Mean Difference (Final Values)|0.037293|STANDARD_ERROR_OF_MEAN|0.131419||0.778|TWO_SIDED|95.0|-0.22667|0.301257|||t-test, 2 sided|50 degrees of freedom||An independent samples t-test was conducted to examine differences between groups in vmPFC activation that was greater when downregulating misophonic versus non-misophonic distress. One participant from each group was excluded for being an outlier||0.301257|-0.226670|.778
71680950|NCT01911780|142880585|SUPERIORITY_OR_OTHER||Adjusted Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|-3.1|2.3|||mixed-effects model repeated measures||As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||2.3|-3.1|
71905306|NCT04348591|143332881|SUPERIORITY||z score|4.69|||<|0.05|TWO_SIDED||||||mixed effects whole-brain using cluster|||Mixed effects (FSL's FLAME 1; Oxford Univ., UK) whole brain analyses using cluster correction following a voxel-wise Z-score threshold of 2.3.||||<.05
71905307|NCT04348591|143332882|SUPERIORITY||Mean Difference (Final Values)|-0.197|STANDARD_ERROR_OF_MEAN|0.283||0.49|TWO_SIDED|95.0|-0.766|0.372|||Mixed Models Analysis|This is the main effect from the MMANOVA analysis for group difference.||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.372|-.766|.49
71921941|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-8.5|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||2.2|-8.5|
71680951|NCT01911780|142880586|SUPERIORITY_OR_OTHER||Adjusted Mean|2.3|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-1.5|6.1|||mixed-effects model repeated measures||Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.|||6.1|-1.5|
71680952|NCT05014815|142880605|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.4698|TWO_SIDED|95.0|0.74|1.33||1-sided p-value|Log Rank|Stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.33|0.74|0.4698
71680953|NCT05014815|142880606|OTHER||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.47|1.26|||||The Mantel-Haenszel common OR and its 95% CI were estimated using a normal approximation of the log odds ratio and the Robins-Breslow-Greenland variance, stratified by PD-L1 expression and histology.|||1.26|0.47|
71680954|NCT05014815|142880608|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.67|1.34|||||The HR and its 95% confidence interval (CI) was estimated using a Cox regression model stratified by PD-L1 expression (\<1% of tumor cells (TC) vs 1-49% TC vs \>= 50% TC) and histology (squamous vs non-squamous).|||1.34|0.67|
71680955|NCT02453282|142880617|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.036|TWO_SIDED|97.54|0.564|1.019||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.019|0.564|0.036
71680956|NCT02453282|142880617|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.202|TWO_SIDED|98.77|0.611|1.173||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.173|0.611|0.202
71680957|NCT02453282|142880618|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.705|TWO_SIDED|99.5|0.722|1.534||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.534|0.722|0.705
71680958|NCT02453282|142880619|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.523|TWO_SIDED|95.0|0.836|1.421||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.421|0.836|0.523
71680959|NCT02453282|142880620|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.194|TWO_SIDED|95.0|0.725|1.067||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.067|0.725|0.194
71680960|NCT02453282|142880620|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.952|TWO_SIDED|95.0|0.834|1.213||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.213|0.834|0.952
71680961|NCT02453282|142880620|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.218|TWO_SIDED|95.0|0.931|1.371||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.371|0.931|0.218
71680962|NCT02453282|142880621|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.602|TWO_SIDED|95.0|0.812|1.128||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.128|0.812|0.602
71905308|NCT04348591|143332882|SUPERIORITY||Mean Difference (Final Values)|0.909|STANDARD_ERROR_OF_MEAN|0.147|<|1e-07|TWO_SIDED|95.0|0.62|1.97||This p-value corresponds to the difference between sham and HF-rTMS stimulation|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||1.97|.62|<.0000001
71905309|NCT04348591|143332882|SUPERIORITY||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|0.057|0.605||The test corresponds to the difference between sham and LF-rTMS|Mixed Models Analysis|||The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the main effect of neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||.605|.057|.018
71921942|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-6.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-13.1|-0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||-0.3|-13.1|
71905310|NCT04348591|143332882|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|1e-06|TWO_SIDED||||||Mixed Models Analysis||For participants with misophonia difference in distress produced by a misophonic sound when downregulating misophonic sounds while receiving sham vs.HF-rTMS|The MMANOVA analysis of SUDS used a Toeplitz covariance structure. This analysis presents the interaction effect of group by neurostimulation experimental condition. The outcome variable was the difference between SUDS after each sound presentation and baseline, controlling for racial background, headache, and coil to cortex difference. Two participants were excluded from this analysis, one in each condition, because they provided outlier data.||||<.000001
71680963|NCT02453282|142880621|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.43|TWO_SIDED|95.0|0.794|1.103||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.103|0.794|0.430
71855530|NCT03544229|143225091|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.625|TWO_SIDED|90.0|-0.25|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.25|=0.625
71855531|NCT03544229|143225091|SUPERIORITY||Least-Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.187|=|0.54|TWO_SIDED|90.0|-0.29|0.33||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD nausea symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.33|-0.29|=0.540
71855532|NCT03544229|143225092|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.283|=|0.51|TWO_SIDED|90.0|-0.46|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.46|=0.510
71855533|NCT03544229|143225092|SUPERIORITY||Least-Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.192|=|0.674|TWO_SIDED|90.0|-0.23|0.4||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.40|-0.23|=0.674
71855534|NCT03544229|143225092|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.189|=|0.367|TWO_SIDED|90.0|-0.38|0.25||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD early satiety symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.25|-0.38|=0.367
71855535|NCT03544229|143225093|SUPERIORITY||Least-Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.289|=|0.587|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.587
71905311|NCT04348591|143332883|SUPERIORITY||Mean Difference (Final Values)|9.53|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|||||This is the result corresponding to the main effect of time in the repeated measures ANCOVA|ANCOVA|||Repeated measures ANOVA (controlling for racial background)||||<.001
71905312|NCT04348591|143332883|SUPERIORITY||||||>|0.012|||||||ANCOVA|This analysis corresponds to the main effect of group.||Repeated measures ANOVA (controlling for racial background)||||>.012
71905313|NCT04348591|143332884|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Anxiety subscale||||.78
71905314|NCT04348591|143332884|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Depression subscale||||.29
71905315|NCT04348591|143332884|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Fatigue subscale||||.64
71905316|NCT04348591|143332884|SUPERIORITY|||||||0.16|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Sleep disturbance subscale||||.16
71905317|NCT04348591|143332884|SUPERIORITY|||||||0.56|||||||t-test, 2 sided|||An independent samples t-test was conducted to examine between group differences at the intake assessment on the PROMIS Ability to partake in social roles subscale||||.56
71905318|NCT01778127|143332890|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
71905319|NCT01778127|143332890|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||t-test, 2 sided|||||||0.18
71905320|NCT01778127|143332890|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||0.14
71905321|NCT01778127|143332891|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71905322|NCT01778127|143332891|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
71905323|NCT01778127|143332891|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
71905324|NCT01778127|143332892|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71680964|NCT02453282|142880621|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.802|TWO_SIDED|95.0|0.828|1.157||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.157|0.828|0.802
71680965|NCT02453282|142880622|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.324|TWO_SIDED|95.0|0.667|1.143||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.143|0.667|0.324
71855536|NCT03544229|143225093|SUPERIORITY||Least-Squares Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.196|=|0.6|TWO_SIDED|90.0|-0.27|0.37||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.37|-0.27|=0.600
71855537|NCT03544229|143225093|SUPERIORITY||Least-Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.193|=|0.446|TWO_SIDED|90.0|-0.34|0.29||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD postprandial fullness symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.29|-0.34|=0.446
71855538|NCT03544229|143225094|SUPERIORITY||Least-Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.245|=|0.562|TWO_SIDED|90.0|-0.37|0.44||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.44|-0.37|=0.562
71855539|NCT03544229|143225094|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.166|=|0.138|TWO_SIDED|90.0|-0.46|0.09||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.46|=0.138
71855540|NCT03544229|143225094|SUPERIORITY||Least-Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.164|=|0.394|TWO_SIDED|90.0|-0.32|0.23||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD upper abdominal pain symptom score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.23|-0.32|=0.394
71855541|NCT03544229|143225095|SUPERIORITY||Least-Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.484|=|0.709|TWO_SIDED|90.0|-0.53|1.07||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||1.07|-0.53|=0.709
71855542|NCT03544229|143225095|SUPERIORITY||Least-Squares Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.332|=|0.76|TWO_SIDED|90.0|-0.31|0.78||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.78|-0.31|=0.760
71855543|NCT03544229|143225095|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.33|=|0.591|TWO_SIDED|90.0|-0.47|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD recorded vomiting frequency was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.47|=0.591
71855544|NCT03544229|143225096|SUPERIORITY||Least-Squares Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.27|=|0.742|TWO_SIDED|90.0|-0.27|0.62||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.62|-0.27|=0.742
71905325|NCT01778127|143332892|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||t-test, 2 sided|||||||0.63
71905326|NCT01778127|143332892|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
71905327|NCT01778127|143332893|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71905328|NCT01778127|143332893|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||t-test, 2 sided|||||||0.43
71905329|NCT01778127|143332893|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
71905330|NCT01778127|143332894|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||t-test, 2 sided|||||||0.61
71905331|NCT01778127|143332894|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||t-test, 2 sided|||||||0.64
71905332|NCT01778127|143332894|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
71905333|NCT01778127|143332895|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||t-test, 2 sided|||||||0.69
71905334|NCT01778127|143332895|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
71905335|NCT01778127|143332895|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||t-test, 2 sided|||||||0.59
71905336|NCT01778127|143332896|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
71905337|NCT01778127|143332896|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
71905338|NCT01778127|143332896|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71905339|NCT01778127|143332897|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71905340|NCT01778127|143332897|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71905341|NCT01778127|143332897|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||t-test, 2 sided|||||||0.99
71905342|NCT01778127|143332898|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|||||||0.44
71905343|NCT01778127|143332898|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||||||0.19
71905344|NCT01778127|143332898|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.54
71905345|NCT01778127|143332899|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||t-test, 2 sided|||||||0.17
71905346|NCT01778127|143332899|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||t-test, 2 sided|||||||0.13
71905347|NCT01778127|143332899|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
71905348|NCT01778127|143332900|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71905349|NCT01778127|143332900|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
71905350|NCT01778127|143332900|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71905351|NCT01778127|143332901|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71905352|NCT01778127|143332901|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71905353|NCT01778127|143332901|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||t-test, 2 sided|||||||0.81
71905354|NCT02104804|143332902|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.58|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.72|-0.45|||ANCOVA|||||-0.45|-0.72|<0.001
71905355|NCT02104804|143332903|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6133.2|STANDARD_ERROR_OF_MEAN|781.06|<|0.001|TWO_SIDED|95.0|-7668.5|-4597.9|||ANCOVA|||||-4597.9|-7668.5|<0.001
71905356|NCT02104804|143332904|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-39.11|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-49.41|-28.82|||ANCOVA|||||-28.82|-49.41|<0.001
71905357|NCT02104804|143332905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8||||0.002|TWO_SIDED|95.0|3.1|12.6|||Difference in proportions|||||12.6|3.1|0.002
71905358|NCT02104804|143332906|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.88|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-21.53|-10.22|||ANCOVA|||||-10.22|-21.53|<0.001
71905359|NCT02104804|143332907|SUPERIORITY_OR_OTHER||Difference in Least squares mean|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.43|TWO_SIDED|95.0|-0.44|0.19|||ANCOVA|||||0.19|-0.44|0.430
71905360|NCT01348425|143332908|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.|Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|4.1|<|0.01|TWO_SIDED|95.0|-2.0|3.5||Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents.|t-test, 2 sided|To test the hypothesis whether the percent change in stent length is contained within \[-10%, 10%\].||The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.||3.5|-2.0|<0.01
71905361|NCT01968954|143332937|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-57.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|-61.0|-53.1|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-53.1|-61.0|<0.001
71905362|NCT01968954|143332938|SUPERIORITY_OR_OTHER||LS mean difference|-36.2|STANDARD_ERROR_OF_MEAN|1.33|<|0.001|TWO_SIDED|95.0|-38.8|-33.6|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-33.6|-38.8|<0.001
71905363|NCT01968954|143332938|SUPERIORITY_OR_OTHER||LS mean difference|-34.7|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|95.0|-37.7|-31.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-31.7|-37.7|
71905364|NCT01968954|143332938|SUPERIORITY_OR_OTHER||LS mean difference|-29.0|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|95.0|-32.3|-25.7||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-25.7|-32.3|
71905365|NCT01968954|143332939|SUPERIORITY_OR_OTHER||LS mean difference|-51.6|STANDARD_ERROR_OF_MEAN|1.8|<|0.001|TWO_SIDED|95.0|-55.2|-48.1|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-48.1|-55.2|<0.001
71905366|NCT01968954|143332939|SUPERIORITY_OR_OTHER||LS mean Difference|-50.6|STANDARD_ERROR_OF_MEAN|2.15|||TWO_SIDED|95.0|-54.9|-46.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.4|-54.9|
71905367|NCT01968954|143332939|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-45.8|-36.5||||||Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.5|-45.8|
71905368|NCT01968954|143332940|SUPERIORITY_OR_OTHER||LS mean difference|-51.5|STANDARD_ERROR_OF_MEAN|1.84|<|0.001|TWO_SIDED|95.0|-55.1|-47.9|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-47.9|-55.1|<0.001
71905369|NCT01968954|143332940|SUPERIORITY_OR_OTHER||LS mean difference|-50.6|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-54.6|-46.6||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-46.6|-54.6|
71905370|NCT01968954|143332940|SUPERIORITY_OR_OTHER||LS mean difference|-40.8|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-45.2|-36.3||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-36.3|-45.2|
71905371|NCT01968954|143332941|SUPERIORITY_OR_OTHER||LS mean difference|-2.9|STANDARD_ERROR_OF_MEAN|16.55||0.86|TWO_SIDED|95.0|-35.4|29.5|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||29.5|-35.4|0.860
71905372|NCT01968954|143332941|SUPERIORITY_OR_OTHER||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|25.11|||TWO_SIDED|95.0|-47.2|51.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||51.4|-47.2|
71905373|NCT01968954|143332941|SUPERIORITY_OR_OTHER||LS mean difference|12.9|STANDARD_ERROR_OF_MEAN|29.25|||TWO_SIDED|95.0|-44.5|70.4||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||70.4|-44.5|
71905374|NCT01968954|143332942|SUPERIORITY_OR_OTHER||LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.4|7.0|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||7.0|2.4|<0.001
71905375|NCT01968954|143332942|SUPERIORITY_OR_OTHER||LS mean difference|6.8|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|95.0|4.5|9.1||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||9.1|4.5|
71905376|NCT01968954|143332942|SUPERIORITY_OR_OTHER||LS mean difference|3.3|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|95.0|0.9|5.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.8|0.9|
71905377|NCT01968954|143332943|SUPERIORITY_OR_OTHER||LS mean difference|-59.1|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-63.4|-54.8|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-54.8|-63.4|<0.001
71905378|NCT01968954|143332944|SUPERIORITY_OR_OTHER||LS mean difference|-48.7|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-58.0|-39.3|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-39.3|-58.0|<0.001
71905379|NCT01968954|143332945|SUPERIORITY_OR_OTHER||LS mean difference|-56.0|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-60.8|-51.2||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-51.2|-60.8|
71905380|NCT01968954|143332945|SUPERIORITY_OR_OTHER||LS mean difference|-46.4|STANDARD_ERROR_OF_MEAN|2.77|||TWO_SIDED|95.0|-51.8|-41.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-41.0|-51.8|
71905381|NCT01968954|143332946|SUPERIORITY_OR_OTHER||LS mean difference|-57.6|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-63.1|-52.0||||||TG \<200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-52.0|-63.1|
71905382|NCT01968954|143332946|SUPERIORITY_OR_OTHER||LS mean difference|-47.7|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-53.9|-41.5||||||TG \<200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-41.5|-53.9|
71905383|NCT01968954|143332946|SUPERIORITY_OR_OTHER||LS mean difference|-49.3|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-58.9|-39.8||||||TG \>=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-39.8|-58.9|
71905384|NCT01968954|143332946|SUPERIORITY_OR_OTHER||LS mean difference|-41.2|STANDARD_ERROR_OF_MEAN|5.6|||TWO_SIDED|95.0|-52.2|-30.1||||||TG \>=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-30.1|-52.2|
71905385|NCT01968954|143332947|SUPERIORITY_OR_OTHER||LS mean difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
71905386|NCT01968954|143332947|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
71905387|NCT01968954|143332947|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
71905388|NCT01968954|143332948|SUPERIORITY_OR_OTHER||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|1.8|5.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||5.7|1.8|
71680966|NCT02453282|142880622|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.207|TWO_SIDED|95.0|0.911|1.541||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.541|0.911|0.207
71855545|NCT03544229|143225096|SUPERIORITY||Least-Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.183|=|0.461|TWO_SIDED|90.0|-0.32|0.28||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.28|-0.32|=0.461
71905389|NCT01968954|143332948|SUPERIORITY_OR_OTHER||LS mean difference|4.9|STANDARD_ERROR_OF_MEAN|0.91|||TWO_SIDED|95.0|3.1|6.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||6.7|3.1|
71905390|NCT01968954|143332948|SUPERIORITY_OR_OTHER||LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|95.0|0.7|4.6||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||4.6|0.7|
71905391|NCT01968954|143332949|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.93|||TWO_SIDED|95.0|-1.9|1.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||1.7|-1.9|
71905392|NCT01968954|143332949|SUPERIORITY_OR_OTHER||LS mean difference|1.9|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|95.0|-0.1|3.9||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.9|-0.1|
71905393|NCT01968954|143332949|SUPERIORITY_OR_OTHER||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-1.0|3.1||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.1|-1.0|
71905394|NCT01968954|143332950|SUPERIORITY_OR_OTHER||LS-Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.88|||TWO_SIDED|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.5|-19.9|
71905395|NCT01968954|143332950|SUPERIORITY_OR_OTHER||LS mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-14.7|-25.1|
71905396|NCT01968954|143332950|SUPERIORITY_OR_OTHER||LS mean difference|-9.2|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-2.8|-15.7|
71905397|NCT01968954|143332951|SUPERIORITY_OR_OTHER||LS mean difference|-64.2|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-69.1|-59.2||||||TG \<200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-59.2|-69.1|
71905398|NCT01968954|143332951|SUPERIORITY_OR_OTHER||LS mean difference|-59.6|STANDARD_ERROR_OF_MEAN|5.99|||TWO_SIDED|95.0|-71.4|-47.7||||||TG \>=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region.||-47.7|-71.4|
71905399|NCT01968954|143332952|SUPERIORITY_OR_OTHER||LS mean difference|-63.4|STANDARD_ERROR_OF_MEAN|2.35|||TWO_SIDED|95.0|-68.0|-58.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-58.8|-68.0|
71905400|NCT01968954|143332953|SUPERIORITY_OR_OTHER||LS mean difference|-67.1|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|95.0|-72.2|-62.1||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-62.1|-72.2|
71905401|NCT01968954|143332954|SUPERIORITY_OR_OTHER||LS mean difference|-69.7|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-74.7|-64.6||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-64.6|-74.7|
71905402|NCT01968954|143332955|SUPERIORITY_OR_OTHER||LS mean difference|-47.3|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-50.7|-43.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-43.8|-50.7|
71905403|NCT01968954|143332956|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|STANDARD_ERROR_OF_MEAN|1.17|||TWO_SIDED|95.0|-12.9|-8.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-8.3|-12.9|
71905404|NCT01968954|143332957|SUPERIORITY_OR_OTHER||LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|95.0|1.4|3.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||3.5|1.4|
71905405|NCT01968954|143332958|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
71905406|NCT01968954|143332958|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.7|-1.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.4|-1.7|
71905407|NCT01968954|143332958|SUPERIORITY_OR_OTHER||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.08|||TWO_SIDED|95.0|-1.4|-1.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-1.0|-1.4|
71905408|NCT01968954|143332959|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
71905409|NCT01968954|143332959|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.4|-0.3||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.3|-0.4|
71905410|NCT01968954|143332959|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.3|-0.2||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographical region, triglyceride subgroup.||-0.2|-0.3|
71905411|NCT01968954|143332960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|24.0|||||TWO_SIDED|95.0|13.86|41.64||||||Week 12||41.64|13.86|
71905412|NCT01968954|143332960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.8|||||TWO_SIDED|95.0|9.32|23.56||||||Week 24||23.56|9.32|
71905413|NCT01968954|143332960|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.8|||||TWO_SIDED|95.0|6.36|15.24||||||Week 52||15.24|6.36|
71905414|NCT01968954|143332961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|95.2|||||TWO_SIDED|95.0|52.09|173.91||||||Week 12||173.91|52.09|
71905415|NCT01968954|143332961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|112.2|||||TWO_SIDED|95.0|55.81|225.52||||||Week 24||225.52|55.81|
71905416|NCT01968954|143332961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.1|||||TWO_SIDED|95.0|17.13|49.49||||||Week 52||49.49|17.13|
71905417|NCT00751114|143332974|SUPERIORITY_OR_OTHER||adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.77|-0.42||An analysis of covariance (ANCOVA) was performed, with the HbA1c change from baseline to last on-treatment measurement as dependent variable, treatment as fixed effect and the corresponding baseline HbA1c value as covariate|ANCOVA||Difference (Insulin glargine - Sitagliptin)|"H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~* Estimated standard deviation of the change in HbA1c of 1.3%~* Expected mean difference to be detected of 0.4%~* Alpha risk of 5% (two-sided)~* Power of 90%~* Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was required"||-0.42|-0.77|<0.0001
71905418|NCT01185249|143333029|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis-no difference in morning and evening weights on three consecutive days.|Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|3.09|<|0.001|TWO_SIDED|95.0|-0.51306|1.73806|||t-test, 1 sided|||Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.||1.73806|-0.51306|<.001
71905419|NCT01185249|143333029|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
71905420|NCT00406783|143333033|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71905421|NCT00406783|143333034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71905422|NCT02300077|143333083|SUPERIORITY|||||||0.0001|||||||Chi-squared|||||||0.0001
71905423|NCT02300077|143333084|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71905424|NCT02300077|143333085|SUPERIORITY|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71855546|NCT03544229|143225096|SUPERIORITY||Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.181|=|0.376|TWO_SIDED|90.0|-0.36|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD overall severity of gastroparesis symptoms score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.36|=0.376
71855547|NCT03544229|143225097|SUPERIORITY||Least-Squares Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.286|=|0.591|TWO_SIDED|90.0|-0.41|0.54||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.54|-0.41|=0.591
71905425|NCT02300077|143333086|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
71905426|NCT02198651|143333100|OTHER|||||||0.943|||||||Wald Chi|||||||0.943
71905427|NCT02198651|143333101|OTHER|||||||0.592|||||||Wald Chi|||||||0.592
71905428|NCT02198651|143333102|OTHER|||||||0.688|||||||Wald Chi|||||||0.688
71905429|NCT04124692|143333151|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71905430|NCT04124692|143333152|SUPERIORITY||||||=|0.0043|||||||Fisher Exact|||||||= 0.0043
71905431|NCT04124692|143333152|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71680967|NCT02453282|142880623|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.383|TWO_SIDED|95.0|0.894|1.339||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.339|0.894|0.383
71680968|NCT02453282|142880623|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.001|TWO_SIDED|95.0|1.136|1.678||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.678|1.136|0.001
71905432|NCT02370498|143333173|OTHER||Hazard Ratio (HR)|1.27||||0.98358|TWO_SIDED|95.0|1.03|1.57||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.57|1.03|0.98358
71905433|NCT02370498|143333174|OTHER||Hazard Ratio (HR)|0.82||||0.04205|TWO_SIDED|95.0|0.66|1.03||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\< 6 months vs. \>= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.03|0.66|0.04205
71905434|NCT02370498|143333175|OTHER||Hazard Ratio (HR)|1.49||||0.99999|TWO_SIDED|95.0|1.25|1.77||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.77|1.25|0.99999
71905435|NCT02370498|143333176|OTHER||Hazard Ratio (HR)|0.94||||0.24463|TWO_SIDED|95.0|0.79|1.12||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio \[HR\]) between the treatment arms.||1.12|0.79|0.24463
71905436|NCT02370498|143333177|OTHER||Hazard Ratio (HR)|0.98||||0.41331|TWO_SIDED|95.0|0.79|1.21||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.21|0.79|0.41331
71905437|NCT02370498|143333178|OTHER||Hazard Ratio (HR)|1.19||||0.97481|TWO_SIDED|95.0|1.0|1.42||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.42|1.00|0.97481
71905438|NCT02370498|143333179|OTHER||Hazard Ratio (HR)|1.11||||0.80696|TWO_SIDED|95.0|0.89|1.38||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.38|0.89|0.80696
71905439|NCT02370498|143333180|OTHER||Hazard Ratio (HR)|1.34||||0.99932|TWO_SIDED|95.0|1.12|1.6||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.60|1.12|0.99932
71905440|NCT02370498|143333181|OTHER||Hazard Ratio (HR)|1.45||||0.99661|TWO_SIDED|95.0|1.11|1.89||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.89|1.11|0.99661
71905441|NCT02370498|143333182|OTHER||Hazard Ratio (HR)|1.77||||1|TWO_SIDED|95.0|1.42|2.2||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||2.20|1.42|1.00000
71905442|NCT02370498|143333183|OTHER||Hazard Ratio (HR)|0.97||||0.3928|TWO_SIDED|95.0|0.77|1.23||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.23|0.77|0.39280
71905443|NCT02370498|143333184|OTHER||Hazard Ratio (HR)|1.21||||0.97033|TWO_SIDED|95.0|1.0|1.47||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\< 6 months vs. \>= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.||1.47|1.00|0.97033
71905444|NCT02370498|143333185|OTHER||Difference in Percentage|2.0||||0.28967|TWO_SIDED|95.0|-5.0|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.0|0.28967
71905445|NCT02370498|143333186|OTHER||Difference in Percentage|-1.3||||0.6901|TWO_SIDED|95.0|-6.5|4.0||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||4.0|-6.5|0.69010
71680969|NCT02453282|142880623|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.138|TWO_SIDED|95.0|0.954|1.403||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.403|0.954|0.138
71680970|NCT02453282|142880624|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.015|TWO_SIDED|95.0|1.043|1.475||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.475|1.043|0.015
71905446|NCT02370498|143333187|OTHER||Difference in Percentage|1.6||||0.3322|TWO_SIDED|95.0|-5.8|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (\<6 months vs. ≥6 months), weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.||9.1|-5.8|0.33220
71905447|NCT02370498|143333188|OTHER||Difference in Percentage|-3.0||||0.85922|TWO_SIDED|95.0|-8.5|2.6||Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (\<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen's method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.||2.6|-8.5|0.85922
71905448|NCT02370498|143333194|OTHER||Difference in Percentage|-3.2|||||TWO_SIDED|95.0|-6.9|0.2||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.||0.2|-6.9|
71905449|NCT01122030|143333198|SUPERIORITY_OR_OTHER|||||||0.0767||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0767
71905450|NCT01122030|143333198|SUPERIORITY_OR_OTHER|||||||0.8727||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8727
71905451|NCT01122030|143333198|SUPERIORITY_OR_OTHER|||||||0.6373||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.6373
71905452|NCT01122030|143333198|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
71905453|NCT01122030|143333198|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
71905454|NCT01122030|143333198|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
71905455|NCT01122030|143333199|SUPERIORITY_OR_OTHER|||||||0.8982||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.8982
71905456|NCT01122030|143333199|SUPERIORITY_OR_OTHER|||||||0.4946||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.4946
71905457|NCT01122030|143333199|SUPERIORITY_OR_OTHER|||||||0.9301||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.9301
71905458|NCT01122030|143333199|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||0.0047
71905459|NCT01122030|143333199|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
71855548|NCT03544229|143225097|SUPERIORITY||Least-Squares mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.193|=|0.291|TWO_SIDED|90.0|-0.43|0.21||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.21|-0.43|=0.291
71905460|NCT01122030|143333199|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.||||||<0.0001
71905461|NCT01122030|143333200|SUPERIORITY_OR_OTHER|||||||0.1334||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.1334
71905462|NCT01122030|143333200|SUPERIORITY_OR_OTHER|||||||0.332||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.3320
71905463|NCT01122030|143333200|SUPERIORITY_OR_OTHER|||||||0.9371||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.9371
71905464|NCT01122030|143333200|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0002
71905465|NCT01122030|143333200|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
71905466|NCT01122030|143333200|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
71905467|NCT01122030|143333201|SUPERIORITY_OR_OTHER|||||||0.7978||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7978
71905468|NCT01122030|143333201|SUPERIORITY_OR_OTHER|||||||0.7143||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7143
71905469|NCT01122030|143333201|SUPERIORITY_OR_OTHER|||||||0.7531||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.7531
71905470|NCT01122030|143333201|SUPERIORITY_OR_OTHER|||||||0.0283||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||0.0283
71905471|NCT01122030|143333201|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
71905472|NCT01122030|143333201|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.||||||<0.0001
71905473|NCT01122030|143333202|SUPERIORITY_OR_OTHER|||||||0.6269||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6269
71680971|NCT02453282|142880624|SUPERIORITY||Hazard Ratio (HR)|1.25||||0.01|TWO_SIDED|95.0|1.054|1.485||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.485|1.054|0.010
71855549|NCT03544229|143225097|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.191|=|0.476|TWO_SIDED|90.0|-0.33|0.3||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD bloating severity scale score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.30|-0.33|=0.476
71905474|NCT01122030|143333202|SUPERIORITY_OR_OTHER|||||||0.7456||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7456
71905475|NCT01122030|143333202|SUPERIORITY_OR_OTHER|||||||0.1968||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.1968
71905476|NCT01122030|143333202|SUPERIORITY_OR_OTHER|||||||0.8708||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.8708
71905477|NCT01122030|143333202|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
71905478|NCT01122030|143333202|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0002
71905479|NCT01122030|143333203|SUPERIORITY_OR_OTHER|||||||0.6131||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.6131
71905480|NCT01122030|143333203|SUPERIORITY_OR_OTHER|||||||0.9293||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.9293
71905481|NCT01122030|143333203|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7990
71905482|NCT01122030|143333203|SUPERIORITY_OR_OTHER|||||||0.7674||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.7674
71905483|NCT01122030|143333203|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||<0.0001
71905484|NCT01122030|143333203|SUPERIORITY_OR_OTHER|||||||0.0018||95.0|||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.||||||0.0018
71905485|NCT01122030|143333204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.7434|TWO_SIDED|95.0|0.42|3.92|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||3.92|0.42|0.7434
71905486|NCT01122030|143333204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54||||0.4449|TWO_SIDED|95.0|0.54|4.42|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||4.42|0.54|0.4449
71905487|NCT01122030|143333204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8129|TWO_SIDED|95.0|0.27|2.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||2.72|0.27|0.8129
71905488|NCT01122030|143333204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.52||||0.0005|TWO_SIDED|95.0|2.29|24.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||24.72|2.29|0.0005
71905489|NCT01122030|143333204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.93|||<|0.0001|TWO_SIDED|95.0|3.09|31.89|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.||||31.89|3.09|<0.0001
71905490|NCT01122030|143333204|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|202272814.0|||<|0.0001||95.0|||||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
71905491|NCT01122030|143333205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.4923|TWO_SIDED|95.0|0.53|4.28|||Log Rank|P-values are from the log rank test stratified by gender.||||4.28|0.53|0.4923
71905492|NCT01122030|143333205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.5479|TWO_SIDED|95.0|0.52|4.06|||Log Rank|P-values are from the log rank test stratified by gender.||||4.06|0.52|0.5479
71905493|NCT01122030|143333205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.506|TWO_SIDED|95.0|0.56|3.67|||Log Rank|P-values are from the log rank test stratified by gender.||||3.67|0.56|0.5060
71905494|NCT01122030|143333205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|7.36||||0.0005|TWO_SIDED|95.0|2.27|23.9|||Log Rank|P-values are from the log rank test stratified by gender.||||23.90|2.27|0.0005
71905495|NCT01122030|143333205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|9.54|||<|0.0001|TWO_SIDED|95.0|3.0|30.35|||Log Rank|P-values are from the log rank test stratified by gender.||||30.35|3.00|<0.0001
71905496|NCT01122030|143333205|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|192233779.0|||<|0.0001||95.0|||||Log Rank|P-values are from the log rank test stratified by gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.|||||<0.0001
71905497|NCT01122030|143333206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.45||||0.1523|TWO_SIDED|95.0|0.62|19.35|||Log Rank|P-values are from the log rank test stratified by gender.||||19.35|0.62|0.1523
71905498|NCT01122030|143333206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.55||||0.0856|TWO_SIDED|95.0|0.76|27.07|||Log Rank|P-values are from the log rank test stratified by gender.||||27.07|0.76|0.0856
71905499|NCT01122030|143333206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.81||||0.5284|TWO_SIDED|95.0|0.3|10.98|||Log Rank|P-values are from the log rank test stratified by gender.||||10.98|0.30|0.5284
71905500|NCT01122030|143333206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.8594|TWO_SIDED|95.0|0.09|8.66|||Log Rank|P-values are from the log rank test stratified by gender.||||8.66|0.09|0.8594
71680972|NCT02453282|142880624|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.984|TWO_SIDED|95.0|0.845|1.179||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.179|0.845|0.984
71680973|NCT02453282|142880625|SUPERIORITY||Odds Ratio (OR)|0.91||||0.698|TWO_SIDED|95.0|0.582|1.437||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.437|0.582|0.698
71680974|NCT02453282|142880625|SUPERIORITY||Odds Ratio (OR)|0.87||||0.534|TWO_SIDED|95.0|0.549|1.363||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.363|0.549|0.534
71680975|NCT02453282|142880625|SUPERIORITY||Odds Ratio (OR)|0.95||||0.82|TWO_SIDED|95.0|0.601|1.496||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.496|0.601|0.820
71680976|NCT02453282|142880626|SUPERIORITY||Odds Ratio (OR)|0.69||||0.05|TWO_SIDED|95.0|0.48|1.0||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.000|0.480|0.050
71680977|NCT02453282|142880626|SUPERIORITY||Odds Ratio (OR)|0.67||||0.029|TWO_SIDED|95.0|0.464|0.959||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.959|0.464|0.029
71680978|NCT02453282|142880626|SUPERIORITY||Odds Ratio (OR)|0.97||||0.887|TWO_SIDED|95.0|0.661|1.43||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.430|0.661|0.887
71855550|NCT03544229|143225098|SUPERIORITY||Least-Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.224|=|0.675|TWO_SIDED|90.0|-0.27|0.47||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.47|-0.27|=0.675
71905501|NCT01122030|143333206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|59.34|||<|0.0001|TWO_SIDED|95.0|6.55|537.38|||Log Rank|P-values are from the log rank test stratified by gender.||||537.38|6.55|<0.0001
71680979|NCT02453282|142880627|SUPERIORITY||Odds Ratio (OR)|0.65||||0.012|TWO_SIDED|95.0|0.462|0.908||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.908|0.462|0.012
71680980|NCT02453282|142880627|SUPERIORITY||Odds Ratio (OR)|0.76||||0.093|TWO_SIDED|95.0|0.543|1.048||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.048|0.543|0.093
71855551|NCT03544229|143225098|SUPERIORITY||Least-Squares Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.152|=|0.531|TWO_SIDED|90.0|-0.24|0.26||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.26|-0.24|=0.531
71680981|NCT02453282|142880627|SUPERIORITY||Odds Ratio (OR)|1.16||||0.406|TWO_SIDED|95.0|0.818|1.647||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (\>=25% Vs \<25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy||1.647|0.818|0.406
71855552|NCT03544229|143225098|SUPERIORITY||Least-Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15|=|0.473|TWO_SIDED|90.0|-0.26|0.24||1-sided p-values were obtained using MMRM Model. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in ANMS GCSI-DD total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.24|-0.26|=0.473
71905502|NCT01122030|143333206|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|10.99||||0.0007|TWO_SIDED|95.0|2.3|52.57|||Log Rank|P-values are from the log rank test stratified by gender.||||52.57|2.30|0.0007
71905503|NCT01122030|143333208|SUPERIORITY_OR_OTHER|||||||0.5054||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.5054
71855553|NCT03544229|143225099|SUPERIORITY||Least-Squares Mean Difference|-8.47|STANDARD_ERROR_OF_MEAN|9.71|=|0.192|TWO_SIDED|90.0|-24.5|7.57||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 -Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.57|-24.50|=0.192
71855554|NCT03544229|143225099|SUPERIORITY||Least-Squares Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|6.736|=|0.236|TWO_SIDED|90.0|-15.98|6.27||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||6.27|-15.98|=0.236
71680982|NCT02453282|142880634|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.03|TWO_SIDED|95.0|0.597|0.975||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||0.975|0.597|0.030
71680983|NCT02453282|142880634|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.045|TWO_SIDED|95.0|0.606|0.994||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||0.994|0.606|0.045
71855555|NCT03544229|143225099|SUPERIORITY||Least-Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|6.689|=|0.297|TWO_SIDED|90.0|-14.62|7.47||The 1-sided p-value was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in symptomatic weeks was \<0.|ANOVA|||||7.47|-14.62|=0.297
71855556|NCT03544229|143225100|SUPERIORITY||Least-Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.3|=|0.601|TWO_SIDED|90.0|-0.42|0.57||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model included week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.57|-0.42|=0.601
71855557|NCT03544229|143225100|SUPERIORITY||Least-Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2|=|0.181|TWO_SIDED|90.0|-0.51|0.15||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.15|-0.51|=0.181
71688698|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|0.85|<|0.0001|TWO_SIDED|90.0|3.16|6.03|||t-test, 2 sided|||FEV1/FVC Day 8 (1 hrs post-dose)||6.03|3.16|<0.0001
71855558|NCT03544229|143225100|SUPERIORITY||Least-Squares Mean Diferrence|-0.24|STANDARD_ERROR_OF_MEAN|0.196|=|0.114|TWO_SIDED|90.0|-0.56|0.09||1-sided p-values were obtained using MMRM of PAGI-SYM total score. It was based on the one-sided alternative hypothesis testing that the treatment difference (TAK-906 - Placebo) in PAGI-SYM total score was \<0.|MMRM||MMRM model includes week, treatment, participant disease population (DG/IG), treatment-by-week interaction as fixed effects, baseline and baseline score-by-week interaction as covariates, with an unstructured working covariance matrix as default.|||0.09|-0.56|=0.114
71855559|NCT02460562|143225126|SUPERIORITY||||||<|0.05||||||Mean salivary fluoride concentrations (part per million) between groups were assessed at different time points using repeated measures analysis of variance. Saliva fluoride concentration from each groups were compared with baseline using a t-test.|ANOVA|||Mean saliva fluoride concentration (part per million) collected at different time points was compared in order to assess the change in capacity for fluoride release and recharge from the resin denture base and to assess differences between the control and the intervention group.||||<0.05
71855560|NCT02460562|143225127|SUPERIORITY||Odds Ratio (OR)|0.45|||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||Caries assessments were performed to examine the difference in mean number of surface caries (DMFS) ± standard deviation between the control and the intervention groups at baseline and at 1.5 years.The transition (∆Q) of developed new caries surfaces (ICDAS score 1-3) from baseline to 1.5 years of follow-up for the two groups was analyzed with respect to arrest or progress rates. Numbers of new caries surfaces were compared by independent t-test, Pearson chi-square and correlation coefficient.||||<0.05
71855561|NCT03303521|143225128|SUPERIORITY||Odds Ratio (OR)|68.77|||<|0.001|TWO_SIDED|95.0|10.85|2810.85|||Fisher Exact|||||2810.85|10.85|<0.001
71855562|NCT03303521|143225130|SUPERIORITY||Odds Ratio (OR)|35.51|||<|0.001|TWO_SIDED|95.0|8.53|309.48|||Fisher Exact|||||309.48|8.53|<0.001
71855563|NCT02642159|143225152|SUPERIORITY||LS Mean Difference|-32.5|||<|0.0001|TWO_SIDED|97.5|-38.1|-27.0||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Alirocumab group was compared to usual care group using an appropriate contrast statement.||-27.0|-38.1|<0.0001
71855564|NCT02642159|143225153|SUPERIORITY||LS Mean Difference|-33.3|||<|0.0001|TWO_SIDED|97.5|-46.6|-19.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.||-19.9|-46.6|<0.0001
71905504|NCT01122030|143333208|SUPERIORITY_OR_OTHER|||||||0.9688||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9688
71905505|NCT01122030|143333208|SUPERIORITY_OR_OTHER|||||||0.6963||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.6963
71905506|NCT01122030|143333208|SUPERIORITY_OR_OTHER|||||||0.9599||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.9599
71680984|NCT02453282|142880635|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.255|TWO_SIDED|95.0|0.746|1.08||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.080|0.746|0.255
71680985|NCT02453282|142880635|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.534|TWO_SIDED|95.0|0.787|1.132||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.132|0.787|0.534
71680986|NCT02453282|142880636|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.663|TWO_SIDED|95.0|0.824|1.131||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy||1.131|0.824|0.663
71680987|NCT02453282|142880636|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.103|TWO_SIDED|95.0|0.746|1.027||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>=25% Vs \<25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy||1.027|0.746|0.103
71680988|NCT01661933|142880646|SUPERIORITY_OR_OTHER|||||||0.693|TWO_SIDED||||||t-test, 2 sided|||||||0.693
71855565|NCT02642159|143225154|SUPERIORITY||LS Mean Difference|-43.0|||<|0.0001|TWO_SIDED|97.5|-49.7|-36.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-36.3|-49.7|<0.0001
71855566|NCT02642159|143225155|SUPERIORITY||LS Mean Difference|-55.7|||<|0.0001|TWO_SIDED|97.5|-71.8|-39.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||-39.6|-71.8|<0.0001
71855567|NCT02642159|143225156|SUPERIORITY||LS Mean Difference|-26.1|||<|0.0001|TWO_SIDED|97.5|-31.5|-20.7||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.7|-31.5|<0.0001
71855568|NCT02642159|143225157|SUPERIORITY||LS Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-40.0|-14.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-14.8|-40.0|<0.0001
71855569|NCT02642159|143225158|SUPERIORITY||LS Mean Difference|-34.7|||<|0.0001|TWO_SIDED|97.5|-40.8|-28.6||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-28.6|-40.8|<0.0001
71855570|NCT02642159|143225159|SUPERIORITY||LS Mean Difference|-49.7|||<|0.0001|TWO_SIDED|97.5|-63.7|-35.8||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).||-35.8|-63.7|<0.0001
71855571|NCT02642159|143225160|SUPERIORITY||LS Mean Difference|-32.3|||<|0.0001|TWO_SIDED|97.5|-37.3|-27.2||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-27.2|-37.3|<0.0001
71855572|NCT02642159|143225161|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|97.5|-47.4|-22.9||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-22.9|-47.4|<0.0001
71905507|NCT01122030|143333208|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0001
71905508|NCT01122030|143333208|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
71905509|NCT01122030|143333209|SUPERIORITY_OR_OTHER|||||||0.3441||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.3441
71905510|NCT01122030|143333209|SUPERIORITY_OR_OTHER|||||||0.7159||95.0||||P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|ANCOVA|||||||0.7159
71905511|NCT01122030|143333209|SUPERIORITY_OR_OTHER|||||||0.7342||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.7342
71680989|NCT01661933|142880647|SUPERIORITY_OR_OTHER||||||=|0.837|TWO_SIDED||||||t-test, 2 sided|||||||=0.837
71855573|NCT02642159|143225162|SUPERIORITY||LS Mean Difference|-24.6|||<|0.0001|TWO_SIDED|97.5|-28.8|-20.3||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.3|-28.8|<0.0001
71855574|NCT02642159|143225163|SUPERIORITY||LS Mean Difference|-25.3|||<|0.0001|TWO_SIDED|97.5|-35.4|-15.1||Threshold for significance \<=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-15.1|-35.4|<0.0001
71855575|NCT02642159|143225164|SUPERIORITY||Adjusted Mean Difference|-27.4|||<|0.0001|TWO_SIDED|97.5|-34.6|-20.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||-20.1|-34.6|<0.0001
71855576|NCT02642159|143225165|SUPERIORITY||Adjusted Mean Difference|-22.8||||0.004|TWO_SIDED|97.5|-40.6|-5.0||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).||-5.0|-40.6|0.0040
71855577|NCT02642159|143225166|SUPERIORITY||Adjusted Mean Difference|-4.2||||0.2191|TWO_SIDED|97.5|-11.8|3.4||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).||3.4|-11.8|0.2191
71855578|NCT02642159|143225167|SUPERIORITY||Adjusted Mean Difference|9.0||||0.2651|TWO_SIDED|97.5|-9.1|27.1||Threshold for significance \<=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|27.1|-9.1|0.2651
71680990|NCT01661933|142880648|SUPERIORITY_OR_OTHER||||||=|0.99|ONE_SIDED||||||Binomial distribution|||The null hypothesis was that irrespective of hookworm infection, GC-1g would result in a 2-point or more deterioration in the Marsh score. A binomial (yes=deterioration or no=no deterioration) distribution was applied to pre- and post-GC-1g paired biopsies.||||=0.99
71680991|NCT01661933|142880649|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Mixed effects model.|||||||=0.005
71855579|NCT00187135|143225181|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
71855580|NCT00187135|143225181|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.||||0.5
71905512|NCT01122030|143333209|SUPERIORITY_OR_OTHER|||||||0.8714||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.8714
71905513|NCT01122030|143333209|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||<0.0001
71680992|NCT02720744|142880653|SUPERIORITY||Mean Difference (Net)|6.13|||<|0.001|TWO_SIDED|95.0|3.52|8.75||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline (or its log transformation).|Difference from placebo was defined by the FT218 mean value minus placebo value.|||8.75|3.52|<0.001
71680993|NCT02720744|142880654|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.001|TWO_SIDED|95.0|2.76|11.23||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|GLIMMIX model|P-values estimated with categorized CGI-Improvement response (very much or much improved versus other category) at the specific visit.||||11.23|2.76|<0.001
71855581|NCT00187135|143225182|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.||||0.5
71855582|NCT00187135|143225183|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.||||0.87
71855583|NCT00187135|143225184|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.||||0.67
71855584|NCT00187135|143225185|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.||||0.52
71855585|NCT00187135|143225186|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.||||0.99
71855586|NCT00297778|143225187|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0103||95.0|-3.4|-0.5|||ANCOVA|||||-0.5|-3.4|0.0103
71905514|NCT01122030|143333209|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.||||||0.0006
71905515|NCT03943953|143333278|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.018|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.018
71680994|NCT02720744|142880655|SUPERIORITY||Mean Difference (Net)|-6.65|||<|0.001|TWO_SIDED|95.0|-9.32|-3.98||Each outcome measure for the 9.0 g, 7.5 g, and 6.0 g doses were tested at the 2-sided α level of 0.05.|Mixed Models Analysis|P-values were estimated using an MMRM with change from baseline to the end of the respective treatment period.||||-3.98|-9.32|<0.001
71855587|NCT00297778|143225188|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.758||||0.0535||95.0|0.992|3.115|||Regression, Logistic|||||3.115|0.992|0.0535
71855588|NCT00297778|143225189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0346||95.0|-1.5|-0.1|||ANCOVA|||||-0.1|-1.5|0.0346
71855589|NCT00297778|143225190|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.5244||95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|-1|0.5244
71855590|NCT00297778|143225191|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.141||95.0|0.0|0.0|||van Elteren (country stratification)|||||0|0|0.141
71855591|NCT00297778|143225192|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.003||95.0|-1.9|-0.4|||ANCOVA|||||-0.4|-1.9|0.003
71855592|NCT00297778|143225193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0034||95.0|-3.7|-0.7|||ANCOVA|||||-0.7|-3.7|0.0034
71855593|NCT00297778|143225194|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4||||0.0007||95.0|-5.4|-1.5|||ANCOVA|||||-1.5|-5.4|0.0007
71855594|NCT00297778|143225195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.821||||0.006||95.0|1.187|2.794|||Regression, Logistic|||||2.794|1.187|0.006
71855595|NCT00297778|143225196|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.3||||0.1925||95.0|-3.3|0.8|||van Elteren (country stratification)|||||0.8|-3.3|0.1925
71855596|NCT00297778|143225197|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.04||||0.0337||95.0|0.0|0.09|||Wilcoxon rank sum (Van Elteren's test)|||||0.09|0|0.0337
71855597|NCT00297778|143225198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.8471||95.0|-5.6|4.6|||ANCOVA|||||4.6|-5.6|0.8471
71855598|NCT00297778|143225199|SUPERIORITY_OR_OTHER||Hodges-Lehmann est of diff in medians|0.0||||0.141|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon rank sum (Van Elteren's test)||95% Confidence interval is Distribution-free Confidence Interval (Moses).|N's exclude patients from the analysis set with incomplete data||0.0|0.0|0.1410
71855599|NCT00297778|143225200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5231|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||N's exclude patients from the analysis set with incomplete data||0.2|-0.5|0.5231
71855600|NCT03280108|143225203|NON_INFERIORITY|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.|Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0103|||ONE_SIDED|95.0||0.041||||||||0.041||
71855601|NCT03280108|143225204|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71855602|NCT03280108|143225210|SUPERIORITY||Least Squares Mean Difference|-0.257|STANDARD_ERROR_OF_MEAN|0.0153|<|0.001|TWO_SIDED|95.0|-0.287|-0.227|||Mixed Models Analysis|||||-0.227|-0.287|<0.001
71855603|NCT03280108|143225211|SUPERIORITY||Mantel-Haenszel common difference|71.2|||||TWO_SIDED|95.0|61.87|80.46||||||||80.46|61.87|
71855604|NCT02109107|143225236|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|t=21.33; df=53||||||<.0001
71855605|NCT02109107|143225237|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|t=2.95; df=53||||||<0.05
71855606|NCT02109107|143225238|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||t-test, 2 sided|t+3.34; df=53||||||<0.005
71855607|NCT00607789|143225247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_DEVIATION|1.7|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods||||<0.05
71855608|NCT05401149|143225262|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.87|||<|0.001|TWO_SIDED|95.0|1.35|2.59|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.59|1.35|<0.001
71855609|NCT05401149|143225263|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|1.43||||0.054|TWO_SIDED|95.0|0.99|2.06|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.06|0.99|0.054
71855610|NCT05401149|143225264|OTHER|OR (95% CI) and P values were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.07||||0.097|TWO_SIDED|95.0|0.88|4.86|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||4.86|0.88|0.097
71855611|NCT05401149|143225265|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the conditional logistic regression models with stratification by matching pairs and adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.48|2.75|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||2.75|1.48|<0.001
71855612|NCT05401149|143225266|OTHER|Odds Ratio (OR) (95% CI) and P values for this outcome were derived from the ordinal logistic regression models with adjustment for prior modified Rankin Scale (mRS) score (≤ 1 or not), baseline National Institutes of Health Stroke Scale (NIHSS) score, and time from symptom onset to hospital admission.|Odds Ratio (OR)|0.77||||0.007|TWO_SIDED|95.0|0.64|0.93|||Regression, Logistic||IV rt-PA cohort/Non-reperfusion cohort|||0.93|0.64|0.007
71855613|NCT05401149|143225267|OTHER|Hazard ratio (HR) (95% Confidence Interval) and P values were derived from the cox proportional hazards models with stratification by matching pairs and adjustment for prior mRS score (≤ 1 or not), baseline NIHSS score, and time from symptom onset to hospital admission.|Hazard Ratio (HR)|1.26||||0.077|TWO_SIDED|95.0|0.98|1.64|||Regression, Cox||IV rt-PA cohort/Non-reperfusion cohort|||1.64|0.98|0.077
71855614|NCT02264353|143225274|SUPERIORITY|||||||0.576|||||||t-test, 2 sided|||||||0.576
71855615|NCT02264353|143225275|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||0.394
71855616|NCT02264353|143225276|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
71855617|NCT02269917|143225293|NON_INFERIORITY|4|Difference in percentage|0.4|||<|0.001|TWO_SIDED|95.0|-1.5|2.2|||Stratum-adjusted Mantel-Haenszel (MH)|||||2.2|-1.5|<0.001
71855618|NCT02269917|143225298|OTHER||Least Square (LS) Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.623|=|0.58|TWO_SIDED|95.0|-0.88|1.57|||ANCOVA|||Change at Week 24||1.57|-0.88|=0.580
71855619|NCT02269917|143225298|OTHER||Least Square (LS) Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.646|=|0.34|TWO_SIDED|95.0|-0.65|1.88|||ANCOVA|||Change at Week 48||1.88|-0.65|=0.340
71855620|NCT02269917|143225299|OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.874|=|0.506|TWO_SIDED|95.0|-2.3|1.13|||ANCOVA|||Change at Week 24||1.13|-2.30|=0.506
71855621|NCT02269917|143225299|OTHER||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.862|=|0.392|TWO_SIDED|95.0|-2.43|0.95|||ANCOVA|||Change Week 48||0.95|-2.43|=0.392
71855622|NCT02269917|143225300|OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.624|=|0.143|TWO_SIDED|95.0|-2.14|0.31|||ANCOVA|||Change at Week 24||0.31|-2.14|=0.143
71855623|NCT02269917|143225300|OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|0.646|=|0.092|TWO_SIDED|95.0|-2.36|0.18|||ANCOVA|||Change at Week 48||0.18|-2.36|=0.092
71855624|NCT02269917|143225301|OTHER||LS Mean Difference|1.14|STANDARD_ERROR_OF_MEAN|0.59|=|0.054|TWO_SIDED|95.0|-0.02|2.29|||ANCOVA|||Change at Week 24||2.29|-0.02|=0.054
71855625|NCT02269917|143225301|OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.63|=|0.034|TWO_SIDED|95.0|0.1|2.57|||ANCOVA|||Change at Week 48||2.57|0.10|=0.034
71855626|NCT02269917|143225302|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 24||||<0.001
71855627|NCT02269917|143225302|OTHER||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 48||||<0.001
71855628|NCT02269917|143225302|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 24||||<0.001
71855629|NCT02269917|143225302|OTHER||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 48||||<0.001
71855630|NCT02269917|143225303|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 24||||<0.001
71855631|NCT02269917|143225303|OTHER||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 48||||<0.001
71855632|NCT02269917|143225303|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 24||||<0.001
71855633|NCT02269917|143225303|OTHER||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 48||||<0.001
71855634|NCT02269917|143225304|OTHER||||||=|0.288|||||||Van Elteren Test|||FEPO4 - Change at Week 24||||=0.288
71855635|NCT02269917|143225304|OTHER||||||=|0.148|||||||Van Elteren Test|||FEPO4 - Change at Week 48||||=0.148
71855636|NCT02269917|143225315|OTHER||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.697|2.037|||ANCOVA|||Spine BMD: Percent change at Week 24||2.037|0.697|<0.001
71855637|NCT02269917|143225315|OTHER||LS Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.277|2.814|||ANCOVA|||Spine BMD: Percent change at Week 48||2.814|1.277|<0.001
71855638|NCT02269917|143225315|OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.272|=|0.001|TWO_SIDED|95.0|0.366|1.436|||ANCOVA|||Hip BMD: Percent change at Week 24||1.436|0.366|=0.001
71855639|NCT02269917|143225315|OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|1.144|2.248|||ANCOVA|||Hip BMD: Percent change at Week 48||2.248|1.144|<0.001
71855640|NCT04572997|143225377|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Signed-rank test||||||< 0.0001
71855641|NCT04572997|143225382|OTHER||||||<|0.001|||||||Wilcoxon Signed-rank test|||||||< 0.001
71855642|NCT03443063|143225411|OTHER||Percent (%) ratio of geometric means|104.83|||||TWO_SIDED|90.0|77.41|141.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||141.97|77.41|
71855643|NCT03443063|143225412|OTHER||Percent (%) ratio of geometric means|133.03|||||TWO_SIDED|90.0|107.3|164.93|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||164.93|107.30|
71855644|NCT03443063|143225413|OTHER||Percent (%) ratio of geometric means|150.53|||||TWO_SIDED|90.0|113.16|200.26|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||200.26|113.16|
71855645|NCT03443063|143225414|OTHER||Percent (%) ratio of geometric means|149.84|||||TWO_SIDED|90.0|113.06|198.58|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|||198.58|113.06|
71855646|NCT03443063|143225415|OTHER||Percent (%) ratio of geometric means|80.09|||||TWO_SIDED|90.0|56.07|114.4|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||114.40|56.07|
71855647|NCT03443063|143225415|OTHER||Percent (%) ratio of geometric means|79.51|||||TWO_SIDED|90.0|54.48|116.03|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||116.03|54.48|
71905516|NCT03943953|143333280|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.001|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.001
71680995|NCT02063178|142880697|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This randomized clinical trial was designed to have 90% power to detect a 4% weight loss percent difference at 12 months between the two study arms.||||<0.001
71855648|NCT03443063|143225415|OTHER||Percent (%) ratio of geometric means|72.49|||||TWO_SIDED|90.0|48.08|109.29|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||109.29|48.08|
71855649|NCT03443063|143225417|OTHER||Percent (%) ratio of geometric mean|111.25|||||TWO_SIDED|90.0|91.69|134.99|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||134.99|91.69|
71855650|NCT03443063|143225417|OTHER||Percent (%) ratio of geometric means|80.28|||||TWO_SIDED|90.0|56.81|113.46|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||113.46|56.81|
71855651|NCT03443063|143225417|OTHER||Percent (%) ratio of geometric means|86.71|||||TWO_SIDED|90.0|64.92|115.81|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||115.81|64.92|
71855652|NCT03443063|143225417|OTHER||Percent (%) ratio of geometric means|65.38|||||TWO_SIDED|90.0|41.08|104.04|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||104.04|41.08|
71855653|NCT03443063|143225418|OTHER||Percent (%) ratio of geometric means|114.69|||||TWO_SIDED|90.0|94.45|139.28|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||139.28|94.45|
71855654|NCT03443063|143225418|OTHER||Percent (%) ratio of geometric means|124.94|||||TWO_SIDED|90.0|100.27|155.67|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||155.67|100.27|
71855655|NCT03443063|143225418|OTHER||Percent (%) ratio of geometric means|92.05|||||TWO_SIDED|90.0|66.87|126.71|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||126.71|66.87|
71855656|NCT03443063|143225419|OTHER||Percent (%) ratio of geometric means|136.28|||||TWO_SIDED|90.0|105.62|175.85|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||175.85|105.62|
71855657|NCT03443063|143225419|OTHER||Percent (%) ratio of geometric means|154.29|||||TWO_SIDED|90.0|117.53|202.57|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||202.57|117.53|
71855658|NCT03443063|143225419|OTHER||Percent (%) ratio of geometric means|118.54|||||TWO_SIDED|90.0|87.84|159.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||159.97|87.84|
71855659|NCT03443063|143225420|OTHER||Percent (%) ratio of geometric means|138.62|||||TWO_SIDED|90.0|109.1|176.14|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||176.14|109.10|
71855660|NCT03443063|143225420|OTHER||Percent (%) ratio of geometric means|147.03|||||TWO_SIDED|90.0|109.06|198.22|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||198.22|109.06|
71855661|NCT03443063|143225420|OTHER||Percent (%) ratio of geometric means|136.42|||||TWO_SIDED|90.0|98.19|189.54|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||189.54|98.19|
71855662|NCT03443063|143225421|OTHER||Percent (%) ratio of geometric means|141.07|||||TWO_SIDED|90.0|103.79|191.73|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant||191.73|103.79|
71855663|NCT03443063|143225421|OTHER||Percent (%) ratio of geometric means|124.48|||||TWO_SIDED|90.0|100.58|154.06|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4||154.06|100.58|
71905517|NCT03943953|143333282|SUPERIORITY||Mean Difference (Final Values)|3.88||||0.006|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.006
71905518|NCT03943953|143333284|SUPERIORITY||Mean Difference (Final Values)|-2.28||||0.035|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.035
71905519|NCT03943953|143333286|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.39|TWO_SIDED||||||t-test, 1 sided|||This is a comparison between Time 1 and Time 2||||.39
71905520|NCT01486784|143333296|OTHER||||||||||||||||||Based on the dose limiting toxicities occurring in each dosing cohort, a maximum tolerated dose (MTD) may be determined by assessing the highest dosing level presenting no dose limiting toxicities. An MTD of 17mg/m2 twice weekly was established.|||
71905521|NCT04593940|143333299|SUPERIORITY||Recovery Rate Ratio|1.122||||0.0793|TWO_SIDED|95.0|0.987|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|0.987|0.0793
71905522|NCT04593940|143333299|SUPERIORITY||Recovery Rate Ratio|1.12||||0.0864|TWO_SIDED|95.0|0.984|1.275|||Fine-Gray Proportional Hazards Model|||||1.275|.984|0.0864
71905523|NCT04593940|143333299|SUPERIORITY||Recovery Rate Ratio|1.006||||0.9354|TWO_SIDED|95.0|0.862|1.176|||Fine-Gray Proportional Hazards Model|||||1.176|0.862|0.9354
71905524|NCT04593940|143333300|SUPERIORITY||Odds Ratio (OR)|1.309||||0.0213|TWO_SIDED|95.0|1.041|1.647|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.647|1.041|0.0213
71905525|NCT04593940|143333300|SUPERIORITY||Odds Ratio (OR)|1.174||||0.1732|TWO_SIDED|95.0|0.932|1.48|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.480|0.932|0.1732
71905526|NCT04593940|143333300|SUPERIORITY||Odds Ratio (OR)|0.944||||0.6823|TWO_SIDED|95.0|0.717|1.243|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.243|0.717|0.6823
71905527|NCT04593940|143333301|SUPERIORITY||Odds Ratio (OR)|0.614||||0.0229|TWO_SIDED|95.0|0.403|0.935|||Regression, Logistic|||||0.935|0.403|0.0229
71905528|NCT04593940|143333301|SUPERIORITY||Odds Ratio (OR)|0.629||||0.0281|TWO_SIDED|95.0|0.416|0.951|||Regression, Logistic|||||0.951|0.416|0.0281
71905529|NCT04593940|143333301|SUPERIORITY||Odds Ratio (OR)|1.167||||0.541|TWO_SIDED|95.0|0.711|1.917|||Regression, Logistic|||||1.917|0.711|0.541
71905530|NCT04593940|143333302|SUPERIORITY||Odds Ratio (OR)|1.435||||0.0032|TWO_SIDED|95.0|1.129|1.825|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.825|1.129|0.0032
71905531|NCT04593940|143333302|SUPERIORITY||Odds Ratio (OR)|1.338||||0.0228|TWO_SIDED|95.0|1.041|1.718|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.718|1.041|0.0228
71680996|NCT02063178|142880698|OTHER|Correlation|||||<|0.0001|||||||Correlation|||The association between weight change percent and attendance was described using Spearman rank correlation.||||<0.0001
71680997|NCT02063178|142880699|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
71680998|NCT02063178|142880700|OTHER||||||<|0.0001|||||||Correlation|||||||<0.0001
71680999|NCT01892085|142880702|SUPERIORITY|||||||0.015|||||||Marginalized two part model|||||||0.015
71905532|NCT04593940|143333302|SUPERIORITY||Odds Ratio (OR)|0.904||||0.4994|TWO_SIDED|95.0|0.675|1.211|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.211|0.675|0.4994
71905533|NCT04593940|143333303|SUPERIORITY||Odds Ratio (OR)|0.632||||0.0988|TWO_SIDED|95.0|0.367|1.09|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||1.090|0.367|0.0988
71905534|NCT04593940|143333303|SUPERIORITY||Odds Ratio (OR)|0.552||||0.0354|TWO_SIDED|95.0|0.317|0.96|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||0.960|0.317|0.0354
71905535|NCT04593940|143333303|SUPERIORITY||Odds Ratio (OR)|1.287||||0.4132|TWO_SIDED|95.0|0.703|2.355|||Regression, Logistic|Ordinal logistic regression|Ordinal logistic regression|||2.355|0.703|0.4132
71905536|NCT04593940|143333304|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.1601|TWO_SIDED|95.0|1.0|1.28|||Fine-Gray Proportional Hazards Model|||||1.28|1.00|0.1601
71905537|NCT04593940|143333304|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.355|TWO_SIDED|95.0|0.97|1.24|||Fine-Gray Proportional Hazards Model|||||1.24|0.97|0.3550
71681000|NCT01892085|142880702|SUPERIORITY|||||||0.339|||||||Marginalized two part model|||||||0.339
71681001|NCT01892085|142880703|SUPERIORITY|||||||0.024|||||||Marginalized two part model|||||||0.024
71681002|NCT01892085|142880703|SUPERIORITY|||||||0.317|||||||Marginalized two part model|||||||0.317
71681003|NCT01892085|142880704|SUPERIORITY|||||||0.031|||||||Marginalized two part model|||||||0.031
71681004|NCT01892085|142880704|SUPERIORITY|||||||0.298|||||||Marginalized two part model|||||||0.298
71681005|NCT01892085|142880705|SUPERIORITY|||||||0.05|||||||Marginalized two part model|||||||0.05
71681006|NCT01892085|142880705|SUPERIORITY|||||||0.27|||||||Marginalized 2 part model|||||||0.27
71681007|NCT01892085|142880706|SUPERIORITY|||||||0.069|||||||Marginalized two part model|||||||0.069
71681008|NCT01892085|142880706|SUPERIORITY|||||||0.244|||||||Marginalized two part model|||||||0.244
71905538|NCT04593940|143333304|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2386|TWO_SIDED|95.0|0.8|1.07|||Fine-Gray Proportional Hazards Model|||||1.07|0.80|0.2386
71905539|NCT04593940|143333305|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.1519|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.1519
71905540|NCT04593940|143333305|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.2605|TWO_SIDED|95.0|0.98|1.26|||Fine-Gray Proportional Hazards Model|||||1.26|0.98|0.2605
71905541|NCT04593940|143333305|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.4359|TWO_SIDED|95.0|0.83|1.13|||Fine-Gray Proportional Hazards Model|||||1.13|0.83|0.4359
71905542|NCT04593940|143333306|SUPERIORITY||Mean Difference (Net)|-0.06||||0.321|TWO_SIDED|95.0|-0.18|0.06|||t-test, 2 sided|||||0.06|-0.18|0.3210
71905543|NCT04593940|143333306|SUPERIORITY||Mean Difference (Net)|0.04||||0.5275|TWO_SIDED|95.0|-0.09|0.17|||t-test, 2 sided|||||0.17|-0.09|0.5275
71905544|NCT04593940|143333306|SUPERIORITY||Mean Difference (Net)|0.0||||0.9993|TWO_SIDED|95.0|-0.15|0.15|||t-test, 2 sided|||||0.15|-0.15|0.9993
71905545|NCT04593940|143333307|SUPERIORITY||Mean Difference (Net)|0.07||||0.4982|TWO_SIDED|95.0|-0.13|0.26|||t-test, 2 sided|||||0.26|-0.13|0.4982
71905546|NCT04593940|143333307|SUPERIORITY||Mean Difference (Net)|0.09||||0.3491|TWO_SIDED|95.0|-0.1|0.29|||t-test, 2 sided|||||0.29|-0.10|0.3491
71905547|NCT04593940|143333307|SUPERIORITY||Mean Difference (Net)|-0.01||||0.902|TWO_SIDED|95.0|-0.25|0.22|||t-test, 2 sided|||||0.22|-0.25|0.9020
71905548|NCT04593940|143333308|SUPERIORITY||Mean Difference (Net)|0.24||||0.0842|TWO_SIDED|95.0|-0.03|0.52|||t-test, 2 sided|||||0.52|-0.03|0.0842
71905549|NCT04593940|143333308|SUPERIORITY||Mean Difference (Net)|0.09||||0.5328|TWO_SIDED|95.0|-0.19|0.37|||t-test, 2 sided|||||0.37|-0.19|0.5328
71905550|NCT04593940|143333308|SUPERIORITY||Mean Difference (Net)|-0.12||||0.4727|TWO_SIDED|95.0|-0.46|0.21|||t-test, 2 sided|||||0.21|-0.46|0.4727
71905551|NCT04593940|143333309|SUPERIORITY||Mean Difference (Net)|0.31||||0.0399|TWO_SIDED|95.0|0.01|0.61|||t-test, 2 sided|||||0.61|0.01|0.0399
71905552|NCT04593940|143333309|SUPERIORITY||Mean Difference (Net)|0.11||||0.4515|TWO_SIDED|95.0|-0.18|0.41|||t-test, 2 sided|||||0.41|-0.18|0.4515
71905553|NCT04593940|143333309|SUPERIORITY||Mean Difference (Net)|-0.07||||0.696|TWO_SIDED|95.0|-0.43|0.29|||t-test, 2 sided|||||0.29|-0.43|0.6960
71905554|NCT04593940|143333310|SUPERIORITY||Mean Difference (Net)|0.26||||0.0903|TWO_SIDED|95.0|-0.04|0.57|||t-test, 2 sided|||||0.57|-0.04|0.0903
71905555|NCT04593940|143333310|SUPERIORITY||Mean Difference (Net)|0.15||||0.348|TWO_SIDED|95.0|-0.16|0.45|||t-test, 2 sided|||||0.45|-0.16|0.3480
71905556|NCT04593940|143333310|SUPERIORITY||Mean Difference (Net)|-0.07||||0.6984|TWO_SIDED|95.0|-0.44|0.29|||t-test, 2 sided|||||0.29|-0.44|0.6984
71905557|NCT04593940|143333311|SUPERIORITY||Mean Difference (Net)|0.32||||0.045|TWO_SIDED|95.0|0.01|0.62|||t-test, 2 sided|||||0.62|0.01|0.0450
71905558|NCT04593940|143333311|SUPERIORITY||Mean Difference (Net)|0.19||||0.2462|TWO_SIDED|95.0|-0.13|0.5|||t-test, 2 sided|||||0.50|-0.13|0.2462
71905559|NCT04593940|143333311|SUPERIORITY||Mean Difference (Net)|-0.23||||0.2304|TWO_SIDED|95.0|-0.61|0.15|||t-test, 2 sided|||||0.15|-0.61|0.2304
71681009|NCT01892085|142880707|SUPERIORITY|||||||0.094|||||||Marginalized two part model|||||||0.094
71681010|NCT01892085|142880707|SUPERIORITY|||||||0.235|||||||Marginalized 2 part model|||||||0.235
71681011|NCT01892085|142880708|SUPERIORITY|||||||0.123|||||||Marginalized two part model|||||||0.123
71681012|NCT01892085|142880708|SUPERIORITY|||||||0.21|||||||Marginalized two part model|||||||0.210
71681013|NCT01892085|142880709|SUPERIORITY|||||||0.143|||||||Marginalized two part model|||||||0.143
71681014|NCT01892085|142880709|SUPERIORITY|||||||0.196|||||||Marginalized two part model|||||||0.196
71681015|NCT01892085|142880710|SUPERIORITY|||||||0.185|||||||Marginalized two part model|||||||0.185
71681016|NCT01892085|142880710|SUPERIORITY|||||||0.183|||||||Marginalized two part model|||||||0.183
71681017|NCT01892085|142880711|SUPERIORITY|||||||0.229|||||||Marginalized two part model|||||||0.229
71855664|NCT03443063|143225421|OTHER||Percent (%) ratio of geometric means|143.31|||||TWO_SIDED|90.0|107.72|190.65|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9||190.65|107.72|
71855665|NCT03443063|143225421|OTHER||Percent (%) ratio of geometric means|140.2|||||TWO_SIDED|90.0|98.11|200.35|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10||200.35|98.11|
71855666|NCT00552513|143225434|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.15|TWO_SIDED|95.0|0.68|1.06|||Regression, Logistic|||||1.06|0.68|0.15
71855667|NCT00552513|143225435|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Regression, Logistic|||||0.89|0.58|0.003
71855668|NCT00552513|143225436|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.04|TWO_SIDED|95.0|0.71|0.99|||Regression, Logistic|||||0.99|0.71|0.04
71855669|NCT00197106|143225463|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).|Adjusted difference|2.6||||0.63||95.0|-8.1|13.4|||Repeated Measurements Anal. of Variance|Anal. = Analysis||||13.4|-8.1|0.63
71855670|NCT02679079|143225565|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|2.1||0.89|TWO_SIDED|95.0|-4.4|3.8||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||3.8|-4.4|0.89
71855671|NCT02679079|143225565|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|2.1||0.47|TWO_SIDED|95.0|-2.6|5.6||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||5.6|-2.6|0.47
71855672|NCT02679079|143225566|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.21|TWO_SIDED|95.0|-1.0|0.2||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.2|-1.0|0.21
71855673|NCT02679079|143225566|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.67|TWO_SIDED|95.0|-0.5|0.8||To control for multiplicity, comparisons were tested sequentially. Nominal p-value was not evaluated for statistical significance since first comparison was not statistically significant.|Mixed Models Analysis|||||0.8|-0.5|0.67
71855674|NCT02679079|143225567|SUPERIORITY||Risk Difference (RD)|13.9||||0.24|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years)|Risk difference expressed as percentage.|||||0.24
71855675|NCT02679079|143225567|SUPERIORITY||Risk Difference (RD)|-4.5||||0.71|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.71
71855676|NCT02679079|143225568|SUPERIORITY||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.9||0.52|TWO_SIDED|95.0|-7.7|3.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.9|-7.7|0.52
71855677|NCT02679079|143225568|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|2.9||0.64|TWO_SIDED|95.0|-4.5|7.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||7.2|-4.5|0.64
71905560|NCT04593940|143333312|SUPERIORITY||Mean Difference (Net)|0.35||||0.0313|TWO_SIDED|95.0|0.03|0.66|||t-test, 2 sided|||||0.66|0.03|0.0313
71905561|NCT04593940|143333312|SUPERIORITY||Mean Difference (Net)|0.31||||0.0555|TWO_SIDED|95.0|-0.01|0.63|||t-test, 2 sided|||||0.63|-0.01|0.0555
71905562|NCT04593940|143333312|SUPERIORITY||Mean Difference (Net)|-0.22||||0.271|TWO_SIDED|95.0|-0.6|0.17|||t-test, 2 sided|||||0.17|-0.60|0.2710
71905563|NCT04593940|143333313|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
71905564|NCT04593940|143333313|SUPERIORITY||Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|-0.5|1.6||||||||1.6|-0.5|
71681018|NCT01892085|142880711|SUPERIORITY|||||||0.17|||||||Marginalized two part model|||||||0.170
71681019|NCT01892085|142880712|SUPERIORITY|||||||0.314|||||||Marginalized two part model|||||||0.314
71681020|NCT01892085|142880712|SUPERIORITY|||||||0.162|||||||Marginalized two part model|||||||0.162
71681021|NCT01892085|142880713|SUPERIORITY|||||||0.377|||||||Marginalized two part model|||||||0.377
71681022|NCT01892085|142880713|SUPERIORITY|||||||0.149|||||||Marginalized two part model|||||||0.149
71681023|NCT01892085|142880714|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
71681024|NCT01892085|142880715|SUPERIORITY|||||||0.82|||||||ANOVA|||||||0.82
71681025|NCT01892085|142880716|SUPERIORITY|||||||0.22|||||||Chi-squared|||||||00.22
71681026|NCT01892085|142880717|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
71681027|NCT01892085|142880718|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71681028|NCT01892085|142880719|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
71681029|NCT01892085|142880720|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71681030|NCT01892085|142880721|SUPERIORITY|||||||0.9|||||||Chi-squared|||||||0.90
71855678|NCT02679079|143225569|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|4.5||0.6|TWO_SIDED|95.0|-11.2|6.5||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||6.5|-11.2|0.60
71855679|NCT02679079|143225569|SUPERIORITY||Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|4.5||0.54|TWO_SIDED|95.0|-6.1|11.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||11.7|-6.1|0.54
71855680|NCT02679079|143225570|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.64|TWO_SIDED|95.0|-2.6|1.6||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.6|-2.6|0.64
71855681|NCT02679079|143225570|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.1||0.77|TWO_SIDED|95.0|-2.5|1.9||Comparison was not included in multiplicity adjustment procedure.|ANCOVA|||||1.9|-2.5|0.77
71855682|NCT02679079|143225571|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|1.2||0.45|TWO_SIDED|95.0|-1.4|3.2||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||3.2|-1.4|0.45
71855683|NCT02679079|143225571|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|1.2||0.72|TWO_SIDED|95.0|-2.7|1.9||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.9|-2.7|0.72
71855684|NCT02679079|143225572|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.41|TWO_SIDED|95.0|-0.3|0.7||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||0.7|-0.3|0.41
71855685|NCT02679079|143225572|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|0.2|1.1||Comparison was not included in multiplicity adjustment procedure.|Mixed Models Analysis|||||1.1|0.2|0.01
71855686|NCT02679079|143225573|SUPERIORITY||Risk Difference (RD)|14.8||||0.18|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.18
71855687|NCT02679079|143225573|SUPERIORITY||Risk Difference (RD)|-0.7||||0.95|TWO_SIDED|||||Comparison was not included in multiplicity adjustment procedure.|Cochran-Mantel-Haenszel|Stratified by age group (6 to 11 years, 12 to 17 years).|Risk difference expressed as a percentage.|||||0.95
71855688|NCT04150341|143225574|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.881|TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|||||0.12|-0.14|0.881
71905565|NCT04593940|143333313|SUPERIORITY||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.8|0.7||||||||0.7|-1.8|
71681031|NCT01892085|142880722|SUPERIORITY|||||||0.36|||||||Chi-squared|||||||0.36
71855689|NCT04150341|143225574|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.575|TWO_SIDED|95.0|-0.17|0.1|||Mixed Models Analysis|||||0.1|-0.17|0.575
71855690|NCT01907113|143225646|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.24|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.17|145.38|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||145.38|96.17|
71855691|NCT01907113|143225646|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|119.94|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|96.25|149.47|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||149.47|96.25|
71681032|NCT01629823|142880723|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.51|TWO_SIDED|95.0|0.44|1.5||Comparison of 5cm group to control. No adjustment for multiple comparisons.|Regression, Linear|||Both the 5 and 10cm groups were compared to the control group, \<1cm H₂O||1.50|0.44|0.51
71855692|NCT01907113|143225646|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|166.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|134.44|205.68|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||205.68|134.44|
71855693|NCT01907113|143225646|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|148.29|STANDARD_DEVIATION|25.6|||TWO_SIDED|90.0|119.89|183.42|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||183.42|119.89|
71855694|NCT01907113|143225647|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.83|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|93.62|150.84|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||150.84|93.62|
71855695|NCT01907113|143225647|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|102.27|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|79.33|131.85|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||131.85|79.33|
71855696|NCT01907113|143225647|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|120.68|STANDARD_DEVIATION|29.7|||TWO_SIDED|90.0|94.42|154.25|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||154.25|94.42|
71855697|NCT01907113|143225647|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|103.75|STANDARD_DEVIATION|29.7|||TWO_SIDED|95.0|81.18|132.61|||ANOVA|Based on ANOVA with fixed effect for treatment (corresponding to renal impairment status).|Standard deviation is actually the geometric Coefficient of Variation \[%\].|No formal testing, investigation of relative bioavailability||132.61|81.18|
71905566|NCT04593940|143333314|SUPERIORITY||Difference in percentages|29.2|||||TWO_SIDED|95.0|-0.4|53.7||||||||53.7|-0.4|
71905567|NCT04593940|143333314|SUPERIORITY||Difference in percentages|14.0|||||TWO_SIDED|95.0|-14.8|40.0||||||||40.0|-14.8|
71855698|NCT00833898|143225662|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.020
71855699|NCT00833898|143225663|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Mixed Models Analysis|||||||0.15
71855700|NCT00833898|143225664|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Mixed Models Analysis|||||||0.029
71855701|NCT00833898|143225665|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||0.003
71855702|NCT00833898|143225666|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Mixed Models Analysis|||||||0.012
71855703|NCT00833898|143225667|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||Mixed Models Analysis|||||||0.40
71855704|NCT00833898|143225668|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Mixed Models Analysis|||||||0.44
71855705|NCT00833898|143225669|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Mixed Models Analysis|||||||0.75
71855706|NCT00833898|143225670|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
71855707|NCT00833898|143225671|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||Mixed Models Analysis|||||||0.97
71855708|NCT00833898|143225672|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Mixed Models Analysis|||||||0.55
71855709|NCT00833898|143225673|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
71855710|NCT00833898|143225674|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71855711|NCT00833898|143225675|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Mixed Models Analysis|||||||0.013
71855712|NCT00833898|143225676|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71855713|NCT00833898|143225677|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Mixed Models Analysis|||||||0.26
71855714|NCT00833898|143225678|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.58
71855715|NCT00833898|143225678|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.33
71855716|NCT00833898|143225679|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71855717|NCT00833898|143225680|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.18
71855718|NCT00833898|143225680|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||1.00
71855719|NCT00833898|143225681|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
71855720|NCT00833898|143225681|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
71855721|NCT00833898|143225682|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.43
71855722|NCT00833898|143225682|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)|||||||.72
71855723|NCT01057888|143225694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3|||<|0.05|TWO_SIDED|95.0|1.0|1.7|||Regression, Cox|It is a robust, clustered stratified Cox regression model|The control group serves as the denominator. The telephone reminder group serves as the numerator.|The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.||1.7|1.0|<0.05
71855724|NCT01057888|143225694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6|||<|0.01|TWO_SIDED|95.0|1.3|2.1|||Regression, Cox|We used a robust, clustered, stratified Cox regression model.|The control group represents the denominator. The letter reminder group represents the numerator.|||2.1|1.3|<0.01
71855725|NCT01057888|143225694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.075|TWO_SIDED|95.0|1.0|1.6|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator.|The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder arms||1.6|1.0|0.075
71855726|NCT01057888|143225695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2|||<|0.01|TWO_SIDED|95.0|1.1|1.3|||Regression, Cox||The control group represents the denominator and the mailed reminder group represents the numerator.|The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control group||1.3|1.1|<0.01
71855727|NCT01057888|143225695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||<|0.05|TWO_SIDED|95.0|1.0|1.3|||Regression, Cox||The control group represents the denominator and the telephone reminder group represents the numerator|The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control group||1.3|1.0|<0.05
71855728|NCT01057888|143225695|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.234|TWO_SIDED|95.0|1.0|1.2|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator|The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the intervention||1.2|1.0|0.234
71855729|NCT03972137|143225745|OTHER|A paired-samples t-test was conducted to compare changes in cigarettes smoked per day from Baseline (BL) to Quit Day.|Mean Difference (Final Values)|11.42|STANDARD_DEVIATION|6.08||0.003|TWO_SIDED|95.0|5.79|17.05||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and Quit Date (Mean CPD at Baseline - Mean CPD at Quit Date).|||17.05|5.79|.003
71855730|NCT03972137|143225745|OTHER|A paired-samples t-test was used to evaluate smoking reduction in participants from baseline (BL) to 3-month follow-up session (3MFU).|Mean Difference (Final Values)|11.9|STANDARD_DEVIATION|8.45||0.067|TWO_SIDED|95.0|-1.55|25.35||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean cigarettes smoked per day at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||25.35|-1.55|.067
71905568|NCT04593940|143333314|SUPERIORITY||Difference in percentages|-5.8|||||TWO_SIDED|95.0|-38.7|26.6||||||||26.6|-38.7|
71905569|NCT04593940|143333315|SUPERIORITY||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.2|2.3||||||||2.3|0.2|
71905570|NCT04593940|143333315|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|2.0||||||||2.0|-0.1|
71855731|NCT03972137|143225746|OTHER|A paired-samples t-test was conducted to examine the difference in the DASS-21 total score from baseline (BL) to 2-weeks post-quit (2W).|Mean Difference (Final Values)|19.67|STANDARD_DEVIATION|11.91||0.01|TWO_SIDED|95.0|7.17|32.17||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 2-weeks post-quit. Estimated value reported is reflective of the n=6 participants that attended the 2-weeks post quit session.|||32.17|7.17|.010
71855732|NCT03972137|143225746|OTHER|A paired-samples t-test was conducted to examine the difference in DASS-21 Total scores from baseline (BL) to 1-month post-quit (1M).|Mean Difference (Final Values)|31.2|STANDARD_DEVIATION|20.4||0.027|TWO_SIDED|95.0|5.88|56.52||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 1-month post-quit. Estimated value reported is reflective of the n=5 participants that attended the 1-month post-quit session.|||56.52|5.88|.027
71855733|NCT03972137|143225746|OTHER|A paired-samples t-test was conducted to evaluate the difference in DASS-21 total scores from baseline (BL) to 3-month follow up (3MFU).|Mean Difference (Final Values)|25.75|STANDARD_DEVIATION|15.5||0.045|TWO_SIDED|95.0|1.09|50.41||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Mean difference represents the difference of mean DASS-21 total scores at Baseline and 3-month follow-up. Estimated value reported is reflective of the n=4 participants that attended the 3-month follow-up session.|||50.41|1.09|.045
71855734|NCT03029234|143225769|OTHER|The prespecified threshold that the primary endpoint would be met was if the lower limit of the 95% confidence interval (CI) was greater than 18%.|Overall response rate|35.8|||||TWO_SIDED|95.0|27.3|44.9||||||||44.9|27.3|
71855735|NCT02166047|143225796|SUPERIORITY||Least Squares (LS) Mean Difference|0.023||||0.59|TWO_SIDED|95.0|-0.061|0.108||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.108|-0.061|0.590
71855736|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.068||||0.12|TWO_SIDED|95.0|-0.018|0.154||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.154|-0.018|0.120
71855737|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.017||||0.701|TWO_SIDED|95.0|-0.069|0.102||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.102|-0.069|0.701
71855738|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.082||||0.21|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.210
71855739|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.082||||0.207|TWO_SIDED|95.0|-0.046|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.046|0.207
71855740|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.081||||0.216|TWO_SIDED|95.0|-0.048|0.21||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.210|-0.048|0.216
71855741|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|-0.015||||0.652|TWO_SIDED|95.0|-0.081|0.051||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.051|-0.081|0.652
71855742|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.0||||0.994|TWO_SIDED|95.0|-0.066|0.065||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.065|-0.066|0.994
71855743|NCT02166047|143225796|SUPERIORITY||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.069|0.069||P-value between vesatolimod and placebo was not adjusted for multiplicity due to exploratory nature of the study.|MMRM|||||0.069|-0.069|0.996
71855744|NCT01960114|143225805|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|25.241|STANDARD_ERROR_OF_MEAN|2.8344|<|0.001|TWO_SIDED|95.0|19.669|30.813||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||30.813|19.669|<0.001
71855745|NCT01960114|143225806|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71855746|NCT01960114|143225807|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||<0.001
71855747|NCT01960114|143225808|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.||||<0.001
71855748|NCT01960114|143225809|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||||0.001
71855749|NCT02469077|143225810|SUPERIORITY|||||||0.12|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.12
71855750|NCT02469077|143225811|SUPERIORITY|||||||0.04|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.04
71855751|NCT02469077|143225812|SUPERIORITY|||||||0.03|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.03
71855752|NCT02469077|143225813|SUPERIORITY|||||||0.17|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.17
71855753|NCT02469077|143225814|SUPERIORITY|||||||0.13|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.13
71855754|NCT02469077|143225815|SUPERIORITY|||||||0.98|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.98
71855755|NCT02469077|143225816|SUPERIORITY|||||||0.52|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.52
71855756|NCT02469077|143225817|SUPERIORITY|||||||0.65|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.65
71855757|NCT02469077|143225818|SUPERIORITY|||||||0.1|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.1
71855758|NCT02469077|143225819|SUPERIORITY|||||||0.046|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||.046
71855759|NCT02469077|143225820|SUPERIORITY|||||||0.61|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.61
71855760|NCT02469077|143225821|SUPERIORITY|||||||0.4|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.4
71855761|NCT02469077|143225822|SUPERIORITY|||||||0.57|||||||ANCOVA|||Statistical analysis applies to change after 6 week intervention period||||0.57
71855762|NCT01318538|143225823|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED|95.0|||||loglinear (negative binomial) regression|Analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (relative changes i.e. % change)||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).||||0.821
71855763|NCT01318538|143225824|SUPERIORITY_OR_OTHER|||||||0.519|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).||||0.519
71855764|NCT01318538|143225825|SUPERIORITY_OR_OTHER|||||||0.253|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.253
71855765|NCT01318538|143225826|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED|95.0|||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).||||0.667
71855766|NCT01318538|143225828|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71855767|NCT01318538|143225829|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71855768|NCT01318538|143225830|SUPERIORITY_OR_OTHER|||||||0.464|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p\<0.05) but not for GDC (1.5 day reduction; p\>0.01).||||0.464
71855769|NCT01318538|143225831|SUPERIORITY_OR_OTHER|||||||0.904|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).||||0.904
71855770|NCT01318538|143225832|SUPERIORITY_OR_OTHER|||||||0.799|||||||linear mixed effect model|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p\<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).||||0.799
71855771|NCT00991029|143225833|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.02|TWO_SIDED|95.0|0.59|0.95|||Log Rank|||||0.95|0.59|0.02
71855772|NCT00991029|143225834|SUPERIORITY||Hazard Ratio (HR)|2.32||||0.02|TWO_SIDED|95.0|1.1|4.87|||Log Rank|||||4.87|1.10|0.02
71855773|NCT00991029|143225835|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.01|TWO_SIDED|95.0|0.56|0.92|||Log Rank|||||0.92|0.56|0.01
71855774|NCT00991029|143225836|SUPERIORITY||Hazard Ratio (HR)|1.44||||0.46|TWO_SIDED|95.0|0.55|3.78|||Log Rank|||||3.78|0.55|0.46
71855775|NCT00991029|143225837|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.52|TWO_SIDED|95.0|0.43|5.35|||Log Rank|||||5.35|0.43|0.52
71855776|NCT00991029|143225838|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.01|TWO_SIDED|95.0|0.58|0.94|||Log Rank|||||0.94|0.58|0.01
71855777|NCT00991029|143225839|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.13|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.13
71855778|NCT00991029|143225840|SUPERIORITY||Hazard Ratio (HR)|1.68||||0.47|TWO_SIDED|95.0|0.4|7.03|||Log Rank|||||7.03|0.4|0.47
71855779|NCT00991029|143225841|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.99|TWO_SIDED|95.0|0.14|7.14|||Log Rank|||||7.14|0.14|0.99
71855780|NCT00991029|143225842|SUPERIORITY|||||||0.16|||||||Log Rank|||||||0.16
71855781|NCT00991029|143225843|SUPERIORITY||Hazard Ratio (HR)|2.45||||0.04|TWO_SIDED|95.0|1.01|5.9|||Log Rank|||||5.9|1.01|0.04
71855782|NCT00991029|143225844|SUPERIORITY||Hazard Ratio (HR)|3.12|||<|0.001|TWO_SIDED|95.0|1.67|5.83|||Log Rank|||||5.83|1.67|<0.001
71855783|NCT00991029|143225845|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.27|TWO_SIDED|95.0|0.73|3.13|||Log Rank|||||3.13|0.73|0.27
71855784|NCT02845375|143225865|SUPERIORITY|||||||0.299|||||||ANCOVA|||||||0.299
71855785|NCT05215418|143225866|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.001|||||||ANCOVA|||||||< 0.001
71855786|NCT05215418|143225866|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0059|||||||ANCOVA|||||||0.0059
71855787|NCT05215418|143225866|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.1867|||||||ANCOVA|||||||0.1867
71855788|NCT05215418|143225867|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0277|||||||ANCOVA|||||||0.0277
71855789|NCT05215418|143225867|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0852|||||||ANCOVA|||||||0.0852
71855790|NCT05215418|143225867|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.|||||<|0.0001|||||||ANCOVA|||||||<.0001
71855791|NCT05215418|143225868|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0109|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0109
71855792|NCT05215418|143225868|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0339|||||||ANCOVA|||In-clinic systolic blood pressure||||0.0339
71855793|NCT05215418|143225868|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean SBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.6769|||||||ANCOVA|||In-clinic systolic blood pressure||||0.6769
71681033|NCT01629823|142880723|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.84||||0.57|TWO_SIDED|95.0|0.47|1.52|||Regression, Linear|||||1.52|0.47|0.57
71855794|NCT05215418|143225868|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.0082|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0082
71855795|NCT05215418|143225868|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.8131|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.8131
71905571|NCT04593940|143333315|SUPERIORITY||Mean Difference (Net)|-0.7|||||TWO_SIDED|95.0|-2.0|0.6||||||||0.6|-2.0|
71905572|NCT04593940|143333316|SUPERIORITY||Difference in percentages|-7.0|||||TWO_SIDED|95.0|-14.0|0.0||||||||0.0|-14.0|
71905573|NCT04593940|143333316|SUPERIORITY||Difference in percentages|-3.9|||||TWO_SIDED|95.0|-11.1|3.4||||||||3.4|-11.1|
71905574|NCT04593940|143333316|SUPERIORITY||Difference in percentages|-1.0|||||TWO_SIDED|95.0|-10.1|8.1||||||||8.1|-10.1|
71905575|NCT04593940|143333317|SUPERIORITY||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|-0.1|1.8||||||||1.8|-0.1|
71905576|NCT04593940|143333317|SUPERIORITY||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-0.3|1.7||||||||1.7|-0.3|
71905577|NCT04593940|143333317|SUPERIORITY||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-2.0|0.4||||||||0.4|-2.0|
71905578|NCT04593940|143333318|SUPERIORITY||Difference in percentages|-1.1|||||TWO_SIDED|95.0|-5.7|3.5||||||||3.5|-5.7|
71905579|NCT04593940|143333318|SUPERIORITY||Difference in percentages|-1.3|||||TWO_SIDED|95.0|-6.0|3.3||||||||3.3|-6.0|
71905580|NCT04593940|143333318|SUPERIORITY||Difference in percentages|2.2|||||TWO_SIDED|95.0|-3.7|8.0||||||||8.0|-3.7|
71905581|NCT04593940|143333319|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.0|2.0||||||||2.0|-0.0|
71905582|NCT04593940|143333319|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.7|1.4||||||||1.4|-0.7|
71905583|NCT04593940|143333319|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||||1.1|-1.3|
71905584|NCT04593940|143333320|SUPERIORITY||Hazard Ratio (HR)|0.878||||0.3169|TWO_SIDED|95.0|0.68|1.133|||Log Rank|||||1.133|0.680|0.3169
71905585|NCT04593940|143333320|SUPERIORITY||Hazard Ratio (HR)|0.863||||0.248|TWO_SIDED|95.0|0.672|1.108|||Log Rank|||||1.108|0.672|0.2480
71681034|NCT01393132|142880727|SUPERIORITY_OR_OTHER|||||||0.0108|TWO_SIDED||||||t-test, 2 sided|||Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups||||0.0108
71855796|NCT05215418|143225868|OTHER|If the upper bound of the two-sided 95% confidence interval for the between-treatment group difference (VI-0521 minus placebo or phentermine) in change from baseline in 24-hr mean DBP was less than 3 mmHg, success for a non-inferiority test was claimed and the null hypothesis was rejected. If the upper bound of the two-sided 95% confidence interval was less than 0 mmHg, superiority was claimed.||||||0.015|||||||ANCOVA|||In-clinic diastolic blood pressure||||0.0150
71681035|NCT01393132|142880728|SUPERIORITY_OR_OTHER|||||||0.0141|TWO_SIDED||||||t-test, 2 sided|||Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups||||0.0141
71681036|NCT01393132|142880729|SUPERIORITY_OR_OTHER|||||||0.0162|TWO_SIDED||||||t-test, 2 sided|||Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.||||0.0162
71681037|NCT02003963|142880731|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71855797|NCT01177137|143225869|SUPERIORITY||Slope|-2.35|STANDARD_ERROR_OF_MEAN|3.27||0.47|TWO_SIDED|95.0|-8.77|4.07||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.07|-8.77|0.47
71855798|NCT01177137|143225869|SUPERIORITY||Slope|-2.8|STANDARD_ERROR_OF_MEAN|2.78||0.31|TWO_SIDED|95.0|-8.27|2.65||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.65|-8.27|0.31
71855799|NCT01177137|143225870|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|2.63||0.96|TWO_SIDED|95.0|-5.3|5.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.02|-5.30|0.96
71855800|NCT01177137|143225870|SUPERIORITY||Slope|2.74|STANDARD_ERROR_OF_MEAN|2.53||0.28|TWO_SIDED|95.0|-2.21|7.7||The a priori threshold for statistical significance was \<0.025 to adjust for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.70|-2.21|0.28
71855801|NCT01177137|143225871|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|-0.55|1.77||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.77|-0.55|0.30
71855802|NCT01177137|143225871|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
71855803|NCT01177137|143225873|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|1.37||0.77|TWO_SIDED|95.0|-3.08|2.29||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.29|-3.08|0.77
71855804|NCT01177137|143225873|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|1.3||0.65|TWO_SIDED|95.0|-3.16|1.96||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.96|-3.16|0.65
71855805|NCT01177137|143225874|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.52||0.5|TWO_SIDED|95.0|-1.38|0.67||The a priori threshold for statistical significance was set at \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.67|-1.38|0.50
71855806|NCT01177137|143225874|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.52||0.82|TWO_SIDED|95.0|-1.14|0.9||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.90|-1.14|0.82
71855807|NCT01177137|143225875|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.51||0.46|TWO_SIDED|95.0|-1.37|0.62||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation.|||0.62|-1.37|0.46
71855808|NCT01177137|143225875|SUPERIORITY|The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.51||0.48|TWO_SIDED|95.0|-1.35|0.64|||repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.64|-1.35|0.48
71905586|NCT04593940|143333320|SUPERIORITY||Hazard Ratio (HR)|1.191||||0.249|TWO_SIDED|95.0|0.885|1.604|||Log Rank|||||1.604|0.885|0.2490
71855809|NCT01177137|143225876|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.75|TWO_SIDED|95.0|-0.74|0.53||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.53|-0.74|0.75
71855810|NCT01177137|143225876|SUPERIORITY||Slope|-0.87|STANDARD_ERROR_OF_MEAN|0.35||0.015|TWO_SIDED|95.0|-1.56|-0.17||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.17|-1.56|0.015
71855811|NCT01177137|143225877|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.83|0.69||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.69|-0.83|0.85
71855812|NCT01177137|143225877|SUPERIORITY||Slope|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.55|TWO_SIDED|95.0|-0.86|0.46||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.46|-0.86|0.55
71855813|NCT01177137|143225878|SUPERIORITY||Slope|-3.19|STANDARD_ERROR_OF_MEAN|3.1||0.3|TWO_SIDED|95.0|-9.27|2.88||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.88|-9.27|0.30
71855814|NCT01177137|143225878|SUPERIORITY||Slope|-0.91|STANDARD_ERROR_OF_MEAN|2.98||0.76|TWO_SIDED|95.0|-6.75|4.93||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||4.93|-6.75|0.76
71855815|NCT01177137|143225879|SUPERIORITY||Slope|3.12|STANDARD_ERROR_OF_MEAN|3.34||0.35|TWO_SIDED|95.0|-3.44|9.68||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.68|-3.44|0.35
71855816|NCT01177137|143225879|SUPERIORITY||Slope|3.29|STANDARD_ERROR_OF_MEAN|3.19||0.3|TWO_SIDED|95.0|-2.96|9.54||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||9.54|-2.96|0.30
71855817|NCT01177137|143225880|SUPERIORITY||Slope|1.41|STANDARD_ERROR_OF_MEAN|3.37||0.68|TWO_SIDED|95.0|-5.2|8.02||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||8.02|-5.20|0.68
71855818|NCT01177137|143225880|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|3.26||0.77|TWO_SIDED|95.0|-5.44|7.33||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.33|-5.44|0.77
71855819|NCT01177137|143225881|SUPERIORITY||Slope|-3.53|STANDARD_ERROR_OF_MEAN|4.47||0.43|TWO_SIDED|95.0|-12.3|5.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.23|-12.30|0.43
71855820|NCT01177137|143225881|SUPERIORITY||Slope|-13.7|STANDARD_ERROR_OF_MEAN|4.24||0.001|TWO_SIDED|95.0|-22.02|-5.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-5.38|-22.02|0.001
71855821|NCT01177137|143225882|SUPERIORITY||Slope|3.71|STANDARD_ERROR_OF_MEAN|3.91||0.34|TWO_SIDED|95.0|-3.96|11.38||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||11.38|-3.96|0.34
71905587|NCT04593940|143333321|SUPERIORITY||Hazard Ratio (HR)|1.083||||0.5175|TWO_SIDED|95.0|0.85|1.38|||Log Rank|||||1.380|0.850|0.5175
71905588|NCT04593940|143333321|SUPERIORITY||Hazard Ratio (HR)|0.923||||0.5216|TWO_SIDED|95.0|0.722|1.179|||Log Rank|||||1.179|0.722|0.5216
71905589|NCT04593940|143333321|SUPERIORITY||Hazard Ratio (HR)|1.075||||0.6135|TWO_SIDED|95.0|0.812|1.424|||Log Rank|||||1.424|0.812|0.6135
71905590|NCT04593940|143333322|SUPERIORITY||Hazard Ratio (HR)|0.565||||0.3628|TWO_SIDED|95.0|0.165|1.931|||Log Rank|||||1.931|0.165|0.3628
71681038|NCT03589326|142880741|SUPERIORITY||Risk Difference (RD)|0.18|||=|0.0021|TWO_SIDED|95.0|0.06|0.29||P-value is based on CMH chi-square test, with stratification according to randomization strata (age): 18 through \<45 years, ≥45 through \<60 years, and ≥60 years.|Chi-squared||Risk difference and 95% CI: adjusted percent ponatinib - adjusted percent imatinib and its 95% CI.|||0.29|0.06|=0.0021
71681039|NCT04231396|142880768|SUPERIORITY||Mean Difference (Final Values)|0.1456||||0.037|TWO_SIDED|95.0|0.012|0.279|||t-test, 1 sided|||The SNR Loss scores computed the means per client and week (1-12), with a smoothing method: isotonic regression (isoreg, via R). The slopes (lsfit, via R) calculated of the smoothed means separately per client, per 7-9 weeks (early training weeks), and per 10-12 weeks (final training weeks). This created slope differences, per client.||.279|.012|.037
71681040|NCT00778102|142880777|SUPERIORITY_OR_OTHER||Difference in Resection Rate|12.3||||0.2707|TWO_SIDED|95.0|-11.0|35.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with R0, R1, or R2.||35.5|-11.0|0.2707
71681041|NCT00778102|142880780|SUPERIORITY_OR_OTHER||Difference in Response Rate|-4.8||||0.7817|TWO_SIDED|95.0|-43.0|33.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with complete or major histopathological response.||33.5|-43.0|0.7817
71681042|NCT00778102|142880787|SUPERIORITY_OR_OTHER||Difference in Response Rate (CR or PR)|18.9||||0.0612|TWO_SIDED|95.0|-2.1|40.0|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with confirmed best overall response of CR or PR.||40.0|-2.1|0.0612
71855822|NCT01177137|143225882|SUPERIORITY||Slope|-0.23|STANDARD_ERROR_OF_MEAN|3.82||0.95|TWO_SIDED|95.0|-7.72|7.26||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.26|-7.72|0.95
71855823|NCT01177137|143225883|SUPERIORITY||Slope|-1.85|STANDARD_ERROR_OF_MEAN|3.69||0.62|TWO_SIDED|95.0|-9.07|5.38||The a priori threshold for statistical significance was \< 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||5.38|-9.07|0.62
71855824|NCT01177137|143225883|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|3.58||0.21|TWO_SIDED|95.0|-11.48|2.55||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.55|-11.48|0.21
71855825|NCT01177137|143225884|SUPERIORITY||Slope|-0.13|STANDARD_ERROR_OF_MEAN|3.39||0.97|TWO_SIDED|95.0|-6.78|6.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||6.52|-6.78|0.97
71855826|NCT01177137|143225884|SUPERIORITY||Slope|-3.02|STANDARD_ERROR_OF_MEAN|3.27||0.36|TWO_SIDED|95.0|-9.43|3.4||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||3.40|-9.43|0.36
71855827|NCT01177137|143225885|SUPERIORITY||Slope|1.24|STANDARD_ERROR_OF_MEAN|3.01||0.68|TWO_SIDED|95.0|-4.67|7.14||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||7.14|-4.67|0.68
71855828|NCT01177137|143225885|SUPERIORITY||Slope|-3.52|STANDARD_ERROR_OF_MEAN|2.93||0.23|TWO_SIDED|95.0|-9.26|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-9.26|0.23
71855829|NCT01177137|143225886|SUPERIORITY||Slope|-0.82|STANDARD_ERROR_OF_MEAN|1.27||0.52|TWO_SIDED|95.0|-3.3|1.66||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.66|-3.30|0.52
71855830|NCT01177137|143225886|SUPERIORITY||Slope|-2.81|STANDARD_ERROR_OF_MEAN|1.22||0.022|TWO_SIDED|95.0|-5.21|-0.41||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||-0.41|-5.21|0.022
71855831|NCT01177137|143225887|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.96||0.72|TWO_SIDED|95.0|-1.54|2.23||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||2.23|-1.54|0.72
71905591|NCT04593940|143333322|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.3701|TWO_SIDED|95.0|0.167|1.948|||Log Rank|||||1.948|0.167|0.3701
71905592|NCT04593940|143333322|SUPERIORITY||Hazard Ratio (HR)|4.988||||0.0001|TWO_SIDED|95.0|2.211|11.251|||Log Rank|||||11.251|2.211|0.0001
71855832|NCT01177137|143225887|SUPERIORITY||Slope|-1.04|STANDARD_ERROR_OF_MEAN|0.91||0.26|TWO_SIDED|95.0|-2.83|0.75||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.75|-2.83|0.26
71855833|NCT01177137|143225888|SUPERIORITY||Slope|0.61|STANDARD_ERROR_OF_MEAN|0.59||0.3|TWO_SIDED|95.0|0.55|1.78||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||1.78|0.55|0.30
71681043|NCT01196936|142880825|SUPERIORITY|||||||0.05||||||The calculated p-value is 0.05.|Mixed Models Analysis|||||||0.05
71681044|NCT01196936|142880826|SUPERIORITY|||||||0.0266|||||||Mixed Models Analysis|||||||0.0266
71681045|NCT01196936|142880827|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71681046|NCT01196936|142880828|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71681047|NCT01196936|142880829|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71681048|NCT01196936|142880830|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||> 0.05
71855834|NCT01177137|143225888|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.58||0.29|TWO_SIDED|95.0|-1.75|0.52||The a priori threshold for statistical significance was \<0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation|||0.52|-1.75|0.29
71855835|NCT01287416|143225889|SUPERIORITY_OR_OTHER|||||||0.61||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of SIRI scores across the three time points. We used linear mixed models to determine whether scores were different between the two groups over time.||||0.61
71855836|NCT01287416|143225890|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.95
71855837|NCT01287416|143225891|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in terms of self-reported skill level across the three time points.||||0.33
71855838|NCT01287416|143225892|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.05.|Mixed Models Analysis|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.||||0.03
71855839|NCT01287416|143225893|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The a priori threshold for statistical significance was set at p\<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ on level of self-reported preparedness to help a suicidal person.||||0.63
71855840|NCT01287416|143225894|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||A priori threshold for significance set to p\<.05.|ANCOVA|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ on their level of distress across the two time points.||||0.21
71855841|NCT01287416|143225895|SUPERIORITY_OR_OTHER|||||||0.46||95.0||||A priori threshold for significance set at p\<.05.|ANCOVA|Model was adjusted for differences in educational attainment at baseline.||Null hypothesis was that the groups would not differ in terms of alcohol use across the two time points.||||0.46
71855842|NCT01287416|143225896|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||The a priori threshold for statistical significance was set at p\<.05.|ANCOVA|Model is adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in resiliency scores across the follow-up period.||||0.28
71855843|NCT01287416|143225897|SUPERIORITY_OR_OTHER|||||||0.33||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.33
71855844|NCT01287416|143225898|SUPERIORITY_OR_OTHER|||||||0.62||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|||||||0.62
71855845|NCT01287416|143225899|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
71855846|NCT01287416|143225900|SUPERIORITY_OR_OTHER|||||||1||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||1.00
71855847|NCT01287416|143225901|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||A priori threshold for significance set to p\<.05.|Fisher Exact|||||||0.064
71855848|NCT01287416|143225903|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||a priori threshold for significance set a p\<.05.|Fisher Exact|unadjusted model||Null hypothesis was that the groups would not differ in terms of their gatekeeper behaviours||||0.14
71855849|NCT01287416|143225904|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||A priori threshold for significance set at p\<.05.|Chi-squared|Unadjusted model||Null hypothesis was that the groups would not differ on gatekeeper behaviours.||||0.41
71855850|NCT01196741|143225930|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.57|TWO_SIDED|95.0|0.65|1.23|||Regression, Cox|||||1.23|0.65|0.57
71855851|NCT01196741|143225931|SUPERIORITY_OR_OTHER|||||||0.81|||||||Regression, Cox|||||||0.81
71855852|NCT01196741|143225934|SUPERIORITY_OR_OTHER|||||||0.0476|||||||Mixed Models Analysis|||||||0.0476
71855853|NCT01196741|143225936|SUPERIORITY_OR_OTHER|||||||0.99|||||||Regression, Cox|||||||0.99
71855854|NCT02825849|143225947|SUPERIORITY|||||||0.824|||||||Chi-squared|||||||.824
71905593|NCT03970395|143333358|SUPERIORITY||Risk Ratio (RR)|7.66||||0.01|TWO_SIDED|95.0|2.46|23.84||The threshold for statistical significance was p\<0.5|Risk Ratio (RR)||Risk Difference 0.41 (IC 95; 0.25-0.53)|||23.84|2.46|0.01
71855855|NCT02273180|143225951|NON_INFERIORITY|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 \& Humalog was \<0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure:if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested, demonstrated if lower bound of 2-sided 95%CI of difference between SAR342434 \& Humalog was \>-0.3%.|Least Square (LS) Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.071|||TWO_SIDED|95.0|-0.084|0.197|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.||0.197|-0.084|
71855856|NCT03302559|143226011|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||<0.001
71855857|NCT03302559|143226012|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.005||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.005
71855858|NCT03302559|143226012|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.02
71855859|NCT03302559|143226012|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||0.0006
71855860|NCT03302559|143226012|OTHER|Testing hypothesis is that the mean change from baseline is zero||||||0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.001
71855861|NCT03302559|143226013|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)||||0.02
71855862|NCT03302559|143226013|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)||||0.006
71855863|NCT03302559|143226013|OTHER|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)||||<0.001
71855864|NCT03302559|143226013|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.5||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)||||0.5
71855865|NCT03302559|143226014|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.002||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.002
71681049|NCT01196936|142880831|SUPERIORITY|||||||0.071|||||||Mixed Models Analysis|||||||0.071
71855866|NCT03302559|143226015|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.0008||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.0008
71855867|NCT03302559|143226016|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12||||0.02
71855868|NCT03302559|143226021|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.3||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Normal Skin)||||0.3
71855869|NCT03302559|143226021|OTHER|Testing hypothesis is that the mean change from baseline is zero.||||||0.4||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Target Lesion)||||0.4
71855870|NCT05294328|143226041|SUPERIORITY||Odds Ratio (OR)|34.262|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
71855871|NCT05294328|143226041|SUPERIORITY||Odds Ratio (OR)|73.443|||<|0.0001|TWO_SIDED||||||Generalized Estimating Equation (GEE)|||||||<0.0001
71855872|NCT02056873|143226042|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.05|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||"At 6 months post-surgery the YGTSS scores of each subjects is statistically tested against their baseline scores.~A decrease in this tic severity scale means that the severity of the tics have reduced.~Hence, we performed a superiority test, which statistically verifies if the reduction in the tic severity scale was meaningful."||||0.05
71681050|NCT01196936|142880832|SUPERIORITY|||||||0.739|||||||Mixed Models Analysis|||||||0.739
71681051|NCT01196936|142880833|SUPERIORITY|||||||0.8315|||||||Mixed Models Analysis|||||||0.8315
71855873|NCT01990313|143226047|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||||||0.038
71855874|NCT03511378|143226049|NON_INFERIORITY|Non-inferiority was assessed using a margin of -0.10|Difference in proportions|-0.0296||||0.007|ONE_SIDED|95.0|-0.076||||Difference in proportion|Binomial proportion used to present difference in proportion in treatments||Analysis population : ITT|||-0.076|0.007
71855875|NCT03511378|143226050|NON_INFERIORITY|Noninferiority is assessed using a margin of 10 percentage points.|Difference in proportions|0.0145|||<|0.001|ONE_SIDED|95.0|-0.0092||||Difference in proportion||Difference of proportion analysed with one sided 95% confidence interval|Analysis population: ITT|||-0.0092|<0.001
71855876|NCT00510198|143226059|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0||||The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Log Rank|||This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.||||0.23
71855877|NCT00510198|143226060|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin was 7.5%|Risk Difference (RD)|4.7||||0.36|TWO_SIDED|95.0|-10.9|20.3||The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Two-sample test of proportions||The risk difference estimate is the difference between the Access Arm and Control arm.|||20.3|-10.9|0.36
71855878|NCT02747121|143226106|OTHER|The intervention was external inspections. This is an organizational level intervention and it does not replace any existing intervention.|Odds Ratio (OR)|1.25||||0.24|TWO_SIDED|95.0|0.86|1.8||We used calculated P-values, however only confidence intervals were reported in the published article.|Mixed Models Analysis|||||1.80|0.86|0.24
71855879|NCT01649297|143226110|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.16|0.13||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.13|-0.16|<0.0001
71855880|NCT01649297|143226110|NON_INFERIORITY_OR_EQUIVALENCE|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.26|0.03||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%||0.03|-0.26|<0.0001
71905594|NCT03970395|143333359|SUPERIORITY||Risk Ratio (RR)|5.6||||0.01|TWO_SIDED|95.0|2.36|13.27|||Relative Risk (RR)||Risk Difference 0.47 (IC 95; 0.31-0.64)|||13.27|2.36|0.01
71855881|NCT01649297|143226110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.79|-0.44|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.44|-0.79|<0.0001
71855882|NCT01649297|143226110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.68|-0.32|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.32|-0.68|<0.0001
71855883|NCT01649297|143226110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.62|-0.27|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.27|-0.62|<0.0001
71855884|NCT01649297|143226110|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.6|-0.25|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR \[MDRD\] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).||-0.25|-0.60|<0.0001
71855885|NCT01649297|143226111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-9.0|1.8|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||1.8|-9.0|
71855886|NCT01649297|143226111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.0|STANDARD_ERROR_OF_MEAN|2.8||||95.0|-10.4|0.5||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening (eGFR)\[MDRD\]value)-fixed effects and baseline HbA1c,baseline FPG-linear covariates||||0.5|-10.4|
71855887|NCT01649297|143226111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-34.2|-20.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-20.9|-34.2|<0.0001
71905595|NCT03970395|143333360|SUPERIORITY||Risk Ratio (RR)|7.49||||0.01|TWO_SIDED|95.0|2.42|23.18|||Risk Ratio (RR)||Risk Difference 0.44 (IC 95%; 0.27-0.60)|||23.18|2.42|0.01
71905596|NCT03970395|143333361|SUPERIORITY||Risk Ratio (RR)|4.91||||0.01|TWO_SIDED|95.0|2.12|11.38|||Risk Ratio (RR)||Risk Difference 0.54 (IC 95; 0.36-0.72)|||11.38|2.12|0.01
71905597|NCT00547378|143333389|SUPERIORITY|||||||0.016|||||||Cochran-Mantel-Haenszel|The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups||||||0.016
71905598|NCT04105244|143333406|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
71905599|NCT04105244|143333407|SUPERIORITY||Wald tests|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
71681052|NCT03315455|142880866|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.016|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.016|<0.0001
71855888|NCT01649297|143226111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-29.2|-15.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-15.9|-29.2|<0.0001
71855889|NCT01649297|143226111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-21.1|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-27.7|-14.4|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-14.4|-27.7|<0.0001
71855890|NCT01649297|143226111|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-24.1|-10.8|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)\[MDRD\]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)||-10.8|-24.1|<0.0001
71855891|NCT01685047|143226112|OTHER|There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.|||||<|0.05||||||All events with p \<0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.|t-test, 2 sided|||There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.||||<0.05
71855892|NCT00922441|143226114|OTHER|Efficacy, Safety|||||<|0.05|||||||ANOVA|comparison between the groups||||||<0.05
71855893|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.016|0.092|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.092|0.016|
71855894|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.027|0.103|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.103|0.027|
71855895|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.046|0.122|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.122|0.046|
71855896|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.027|0.049|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.049|-0.027|
71855897|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.008|0.069|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.069|-0.008|
71855898|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.058|-0.019|
71855899|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.051|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.013|0.089|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.089|0.013|
71855900|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.045|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.122|0.045|
71855901|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.042|0.119|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.119|0.042|
71855902|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.071|-0.006|
71855903|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.009|0.068|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.068|-0.009|
71855904|NCT01040403|143226119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.041|0.035|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.035|-0.041|
71855905|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.04|0.159|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.159|0.040|
71855906|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.061|0.179|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.179|0.061|
71855907|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.041|0.16|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.160|0.041|
71855908|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.039|0.079|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.079|-0.039|
71855909|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.061|-0.059|
71681053|NCT03315455|142880866|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.015|0.082||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.082|0.015|<0.0001
71855910|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.04|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.040|-0.079|
71855911|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.071|0.19|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.190|0.071|
71855912|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.191|0.072|
71855913|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.067|0.187|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.187|0.067|
71855914|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|95.0|-0.059|0.061|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.061|-0.059|
71855915|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.063|0.056|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.056|-0.063|
71855916|NCT01040403|143226120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.064|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.064|
71855917|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.035|0.114|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.114|0.035|
71855918|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.137|0.057|
71855919|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.119|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.079|0.159|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.159|0.079|
71855920|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.017|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.062|-0.017|
71855921|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.021|||TWO_SIDED|95.0|0.004|0.085|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.085|0.004|
71855922|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.018|0.062|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.062|-0.018|
71855923|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.057|0.137|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.137|0.057|
71855924|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.088|0.168|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.168|0.088|
71855925|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.103|0.183|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.183|0.103|
71855926|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.071|-0.009|
71855927|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.086|0.006|
71855928|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.025|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.055|-0.025|
71855929|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.04|0.117|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.117|0.040|
71855930|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.06|0.137|||Mixed Models Analysis||difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.137|0.060|
71855931|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.08|0.157|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.157|0.080|
71855932|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|-0.018|0.058|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.058|-0.018|
71855933|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.001|0.079|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.079|0.001|
71855934|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.019|0.058|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.058|-0.019|
71855935|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.06|0.136|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.136|0.060|
71855936|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.083|0.159|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.159|0.083|
71855937|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.105|0.182|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.182|0.105|
71855938|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.062|-0.016|
71855939|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.019|||TWO_SIDED|95.0|0.007|0.084|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.084|0.007|
71855940|NCT01040403|143226121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.016|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.061|-0.016|
71855941|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.058|0.012|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.012|-0.058|
71855942|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.040|-0.029|
71855943|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.034|0.036|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.036|-0.034|
71855944|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.006|0.063|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.063|-0.006|
71855945|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.011|0.059|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.059|-0.011|
71855946|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.039|0.031|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.031|-0.039|
71855947|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.004|0.073|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.073|0.004|
71855948|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.004|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.066|-0.004|
71855949|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|0.006|0.076|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.076|0.006|
71855950|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.043|0.027|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.027|-0.043|
71855951|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.032|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.037|-0.032|
71855952|NCT01040403|143226122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.018|||TWO_SIDED|95.0|-0.025|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.045|-0.025|
71855953|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.041|0.138|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.138|0.041|
71855954|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.024|||TWO_SIDED|95.0|0.043|0.139|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.139|0.043|
71855955|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.066|0.164|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.164|0.066|
71855956|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.046|0.05|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.050|-0.046|
71855957|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.023|0.074|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.074|-0.023|
71855958|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.025|0.072|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.072|-0.025|
71855959|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.059|0.156|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.156|0.059|
71855960|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.084|0.181|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.181|0.084|
71855961|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|0.096|0.193|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.193|0.096|
71855962|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.024|0.074|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.074|-0.024|
71855963|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.01|0.086|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.086|-0.010|
71855964|NCT01040403|143226123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|STANDARD_ERROR_OF_MEAN|0.025|||TWO_SIDED|95.0|-0.036|0.061|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.061|-0.036|
71855965|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.059|0.02|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.020|-0.059|
71855966|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.026|0.053|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.053|-0.026|
71855967|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.028|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.051|-0.028|
71855968|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.006|0.072|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.072|-0.006|
71855969|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.009|0.071|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.071|-0.009|
71855970|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.041|0.037|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.037|-0.041|
71681054|NCT03315455|142880869|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.026|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.026|<0.0001
71681055|NCT03315455|142880869|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.092||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.092|0.028|<0.0001
71855971|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.015|0.093|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.093|0.015|
71681056|NCT03315455|142880872|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.053||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.053|0.006|<0.0001
71681057|NCT03315455|142880872|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.007|0.059||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.059|0.007|<0.0001
71855972|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.006|0.084|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.084|0.006|
71855973|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.008|0.087|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.087|0.008|
71855974|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.049|0.031|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.031|-0.049|
71855975|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.046|0.033|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.033|-0.046|
71855976|NCT01040403|143226124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.037|0.042|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.042|-0.037|
71855977|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.084|0.202|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||0.202|0.084|
71855978|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.092|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||0.210|0.092|
71855979|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.072|0.191|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||0.191|0.072|
71855980|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.051|0.066|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||0.066|-0.051|
71855981|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.071|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||0.048|-0.071|
71855982|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.079|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||0.039|-0.079|
71855983|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||0.234|0.116|
71855984|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.116|0.234|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||0.234|0.116|
71855985|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.14|0.259|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||0.259|0.140|
71855986|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.06|0.059|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||0.059|-0.060|
71855987|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||0.083|-0.035|
71855988|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.035|0.083|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||0.083|-0.035|
71855989|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.081|0.197|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||0.197|0.081|
71855990|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.092|0.207|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||0.207|0.092|
71855991|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.073|0.189|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||0.189|0.073|
71855992|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.047|0.068|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||0.068|-0.047|
71855993|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.066|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||0.051|-0.066|
71855994|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.076|0.039|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||0.039|-0.076|
71681058|NCT03315455|142880875|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.017|0.102||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.102|0.017|<0.0001
71681059|NCT03315455|142880875|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.013|0.084||Statistical significance was controlled at a 2-sided alpha level of 0.05. Hierarchical testing was used to account for multiple comparisons.|Stratified Wald test||The ABR ratio was calculated as Arm B vs. Arm C.|H0 (null hypothesis): ABR Ratio = 1; versus, H1 (alternative hypothesis): ABR Ratio ≠ 1||0.084|0.013|<0.0001
71855995|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.189|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.131|0.247|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||0.247|0.131|
71855996|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.121|0.236|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||0.236|0.121|
71855997|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.213|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|0.155|0.271|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||0.271|0.155|
71855998|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.069|0.048|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||0.048|-0.069|
71855999|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.033|0.082|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||0.082|-0.033|
71856000|NCT01040403|143226125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.023|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||0.092|-0.023|
71856001|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.106|0.01|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.010|-0.106|
71856002|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.051|-0.065|
71856003|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.014|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.072|0.044|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.044|-0.072|
71856004|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.029|||TWO_SIDED|95.0|-0.017|0.099|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.099|-0.017|
71856005|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.024|0.093|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.093|-0.024|
71856006|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.065|0.051|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.051|-0.065|
71856007|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.032|0.148|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.148|0.032|
71856008|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|0.001|0.118|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.118|0.001|
71856009|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.002|0.114|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.114|-0.002|
71856010|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.089|0.028|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.028|-0.089|
71856011|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.092|0.024|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.024|-0.092|
71856012|NCT01040403|143226126|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.03|||TWO_SIDED|95.0|-0.062|0.055|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.055|-0.062|
71856013|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.087|0.223|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.223|0.087|
71905600|NCT04105244|143333408|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
71681060|NCT03315455|142880878|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.163||Not controlled for Type I error|Stratified Wald test||The ABR ratio was calculated as Arm A vs. Arm C.|||0.163|0.016|<0.0001
71681061|NCT03315455|142880878|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.011|0.122||Not controlled for Type I error|ABR Ratio||The ABR ratio was calculated as Arm B vs. Arm C.|||0.122|0.011|<0.0001
71856014|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.079|0.215|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.215|0.079|
71856015|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.058|0.195|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.195|0.058|
71856016|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.075|0.06|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.060|-0.075|
71856017|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.097|0.041|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.041|-0.097|
71856018|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.089|0.048|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.048|-0.089|
71905601|NCT04105244|143333411|SUPERIORITY||Wald test|0.05|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|Intent-to-treat principle using linear mixed-effects models with random intercepts to examine longitudinal change scores for the outcome.||||||<0.05
71856019|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.106|0.242|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.242|0.106|
71856020|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.113|0.25|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.250|0.113|
71856021|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|0.135|0.272|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.272|0.135|
71681062|NCT03315455|142880883|SUPERIORITY||Difference in Adjusted Means|14.68||||0.0515|TWO_SIDED|95.0|-0.1|29.46||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||29.46|-0.10|0.0515
71681063|NCT03315455|142880883|SUPERIORITY||Difference in Adjusted Means|18.33||||0.0204|TWO_SIDED|95.0|2.97|33.68||Type I error controlled|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||33.68|2.97|0.0204
71856022|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.061|0.076|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.076|-0.061|
71856023|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.038|0.098|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.098|-0.038|
71856024|NCT01040403|143226127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.046|0.09|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.090|-0.046|
71856025|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.051|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.114|0.013|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.013|-0.114|
71856026|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.055|0.071|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||0.071|-0.055|
71856027|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.074|0.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.053|-0.074|
71856028|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.004|0.122|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.122|-0.004|
71856029|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.024|0.104|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.104|-0.024|
71856030|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.082|0.045|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus +O 2.5/5|||0.045|-0.082|
71856031|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.047|0.174|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||0.174|0.047|
71856032|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.017|0.144|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.144|0.017|
71856033|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|0.005|0.132|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||0.132|0.005|
71856034|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.094|0.034|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.034|-0.094|
71856035|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.105|0.021|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.021|-0.105|
71856036|NCT01040403|143226128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|-0.075|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.052|-0.075|
71856037|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.759|STANDARD_ERROR_OF_MEAN|4.189|||TWO_SIDED|95.0|10.533|26.985|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h||26.985|10.533|
71856038|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.157|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|16.962|33.351|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h||33.351|16.962|
71856039|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.804|STANDARD_ERROR_OF_MEAN|4.216|||TWO_SIDED|95.0|21.526|38.082|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h||38.082|21.526|
71856040|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.398|STANDARD_ERROR_OF_MEAN|4.173|||TWO_SIDED|95.0|-1.796|14.592|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h||14.592|-1.796|
71856041|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.046|STANDARD_ERROR_OF_MEAN|4.239|||TWO_SIDED|95.0|2.721|19.37|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h||19.370|2.721|
71856042|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.648|STANDARD_ERROR_OF_MEAN|4.204|||TWO_SIDED|95.0|-3.608|12.903|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h||12.903|-3.608|
71856043|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.318|STANDARD_ERROR_OF_MEAN|4.201|||TWO_SIDED|95.0|10.068|26.568|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h||26.568|10.068|
71856044|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.511|STANDARD_ERROR_OF_MEAN|4.197|||TWO_SIDED|95.0|15.27|31.752|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h||31.752|15.270|
71905602|NCT04105244|143333412|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71905603|NCT02768194|143333414|SUPERIORITY||Mean Difference (Net)|-0.11||||0.5512|TWO_SIDED|95.0|-0.46|0.25||From the MMRM model with change from pre-dose as response, participant as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.25|-0.46|0.5512
71905604|NCT02768194|143333414|SUPERIORITY||Mean Difference (Net)|-0.01||||0.9671|TWO_SIDED|95.0|-0.36|0.35||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.35|-0.36|0.9671
71905605|NCT02768194|143333414|SUPERIORITY||Mean Difference (Net)|-0.1||||0.583|TWO_SIDED|95.0|-0.46|0.26||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.|||0.26|-0.46|0.5830
71905606|NCT00363246|143333416|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Chi-squared|||Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.049
71905607|NCT00363246|143333416|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.013
71905608|NCT00363246|143333416|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.0001
71905609|NCT00363246|143333416|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.||||0.009
71905610|NCT00363246|143333417|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED||||||Chi-squared|We used chi-squared test for categorical variable (most variables) and t-test (2-sided) for continuous variables (few variables).||Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.033
71856045|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.817|STANDARD_ERROR_OF_MEAN|4.214|||TWO_SIDED|95.0|14.543|31.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h||31.092|14.543|
71905611|NCT00363246|143333417|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.013
71905612|NCT00363246|143333417|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||<0.001
71905613|NCT00363246|143333417|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.||||0.007
71905614|NCT00099359|143333433|SUPERIORITY_OR_OTHER|||||||0.046||||||Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.|multiple comparison|Hochberg's modified Bonferroni method was used to adjust the significance level for comparisons between arms.||||||.046
71905615|NCT00099359|143333434|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Chi-squared|||||||.0001
71856046|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.193|STANDARD_ERROR_OF_MEAN|4.23|||TWO_SIDED|95.0|-3.115|13.5|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h||13.500|-3.115|
71856047|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.499|STANDARD_ERROR_OF_MEAN|4.185|||TWO_SIDED|95.0|-3.719|12.717|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h||12.717|-3.719|
71856048|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.694|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-8.941|7.554|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h||7.554|-8.941|
71856049|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.751|STANDARD_ERROR_OF_MEAN|4.013|||TWO_SIDED|95.0|10.87|26.632|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h||26.632|10.870|
71856050|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.009|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|18.158|33.86|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h||33.860|18.158|
71905616|NCT00099359|143333435|SUPERIORITY_OR_OTHER|||||||0.2432|||||||multiple comparison|||||||.2432
71905617|NCT00099359|143333436|SUPERIORITY_OR_OTHER|||||||0.49|||||||Chi-squared|||||||0.49
71905618|NCT00099359|143333439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.05|TWO_SIDED|95.0|0.24|1.01|||Regression, Logistic|Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group||||1.01|0.24|0.05
71905619|NCT00099359|143333439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.01|TWO_SIDED|95.0|0.19|0.82||Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.|Regression, Logistic|||||0.82|0.19|0.01
71905620|NCT00099359|143333439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.03|TWO_SIDED|95.0|1.08|5.86|||Regression, Logistic|"Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with NO being reference group."||||5.86|1.08|0.03
71905621|NCT00099359|143333439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.28|||<|0.0001|TWO_SIDED|95.0|1.56|3.35||Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status|Regression, Logistic|||||3.35|1.56|<0.0001
71905622|NCT02720016|143333472|SUPERIORITY||Slope|-3.216|STANDARD_ERROR_OF_MEAN|1.3||0.016|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.016
71856051|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.347|STANDARD_ERROR_OF_MEAN|4.039|||TWO_SIDED|95.0|21.416|37.278|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h||37.278|21.416|
71856052|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.259|STANDARD_ERROR_OF_MEAN|3.998|||TWO_SIDED|95.0|-0.592|15.109|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h||15.109|-0.592|
71856053|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.596|STANDARD_ERROR_OF_MEAN|4.061|||TWO_SIDED|95.0|2.621|18.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h||18.571|2.621|
71856054|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.337|STANDARD_ERROR_OF_MEAN|4.028|||TWO_SIDED|95.0|-4.572|11.247|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h||11.247|-4.572|
71856055|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.654|STANDARD_ERROR_OF_MEAN|4.025|||TWO_SIDED|95.0|11.75|27.558|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h||27.558|11.750|
71856056|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.762|STANDARD_ERROR_OF_MEAN|4.021|||TWO_SIDED|95.0|14.866|30.659|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h||30.659|14.866|
71856057|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.536|STANDARD_ERROR_OF_MEAN|4.038|||TWO_SIDED|95.0|17.607|33.464|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h||33.464|17.607|
71856058|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.108|STANDARD_ERROR_OF_MEAN|4.053|||TWO_SIDED|95.0|-4.852|11.067|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h||11.067|-4.852|
71856059|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.881|STANDARD_ERROR_OF_MEAN|4.009|||TWO_SIDED|95.0|-1.991|13.754|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h||13.754|-1.991|
71856060|NCT01040403|143226129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.773|STANDARD_ERROR_OF_MEAN|4.024|||TWO_SIDED|95.0|-5.129|10.675|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h||10.675|-5.129|
71856061|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.316|STANDARD_ERROR_OF_MEAN|4.371|||TWO_SIDED|95.0|-6.268|10.9|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.900|-6.268|
71856062|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.478|STANDARD_ERROR_OF_MEAN|4.362|||TWO_SIDED|95.0|-4.088|13.044|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.044|-4.088|
71856063|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.668|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-3.978|13.314|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||13.314|-3.978|
71856064|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.162|STANDARD_ERROR_OF_MEAN|4.349|||TWO_SIDED|95.0|-6.379|10.702|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||10.702|-6.379|
71856065|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.352|STANDARD_ERROR_OF_MEAN|4.419|||TWO_SIDED|95.0|-6.326|11.029|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||11.029|-6.326|
71856066|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|-8.43|8.81|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||8.810|-8.430|
71856067|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.488|STANDARD_ERROR_OF_MEAN|4.392|||TWO_SIDED|95.0|-7.136|10.113|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||10.113|-7.136|
71856068|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.262|STANDARD_ERROR_OF_MEAN|4.386|||TWO_SIDED|95.0|-5.35|11.875|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||11.875|-5.350|
71856069|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.121|STANDARD_ERROR_OF_MEAN|4.408|||TWO_SIDED|95.0|-1.535|15.778|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||15.778|-1.535|
71856070|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.774|STANDARD_ERROR_OF_MEAN|4.423|||TWO_SIDED|95.0|-6.91|10.458|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||10.458|-6.910|
71856071|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.663|STANDARD_ERROR_OF_MEAN|4.381|||TWO_SIDED|95.0|-2.97|14.236|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||14.236|-2.970|
71856072|NCT01040403|143226130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.859|STANDARD_ERROR_OF_MEAN|4.403|||TWO_SIDED|95.0|-4.786|12.504|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.504|-4.786|
71856073|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.682|STANDARD_ERROR_OF_MEAN|4.849|||TWO_SIDED|95.0|9.161|28.204|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||28.204|9.161|
71856074|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.599|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|14.116|33.083|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||33.083|14.116|
71856075|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.097|STANDARD_ERROR_OF_MEAN|4.879|||TWO_SIDED|95.0|20.517|39.677|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||39.677|20.517|
71856076|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.917|STANDARD_ERROR_OF_MEAN|4.83|||TWO_SIDED|95.0|-4.568|14.402|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||14.402|-4.568|
71856077|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.415|STANDARD_ERROR_OF_MEAN|4.907|||TWO_SIDED|95.0|1.78|21.05|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||21.050|1.780|
71856078|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.498|STANDARD_ERROR_OF_MEAN|4.866|||TWO_SIDED|95.0|-3.057|16.053|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||16.053|-3.057|
71856079|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.742|STANDARD_ERROR_OF_MEAN|4.862|||TWO_SIDED|95.0|8.194|27.29|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||27.290|8.194|
71856080|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.115|STANDARD_ERROR_OF_MEAN|4.856|||TWO_SIDED|95.0|14.58|33.651|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||33.651|14.580|
71681064|NCT03315455|142880885|SUPERIORITY||Difference in Adjusted Means|6.06||||0.3281|TWO_SIDED|95.0|-6.27|18.4||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||18.40|-6.27|0.3281
71856081|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.095|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|15.52|34.67|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||34.670|15.520|
71856082|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.373|STANDARD_ERROR_OF_MEAN|4.896|||TWO_SIDED|95.0|-3.24|15.986|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||15.986|-3.240|
71856083|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.353|STANDARD_ERROR_OF_MEAN|4.845|||TWO_SIDED|95.0|-2.161|16.866|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||16.866|-2.161|
71856084|NCT01040403|143226131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.98|STANDARD_ERROR_OF_MEAN|4.861|||TWO_SIDED|95.0|-8.566|10.525|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||10.525|-8.566|
71856085|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|STANDARD_ERROR_OF_MEAN|4.853|||TWO_SIDED|95.0|-8.36|10.699|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||10.699|-8.360|
71856086|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.436|STANDARD_ERROR_OF_MEAN|4.843|||TWO_SIDED|95.0|-5.073|13.945|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||13.945|-5.073|
71856087|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.189|STANDARD_ERROR_OF_MEAN|4.887|||TWO_SIDED|95.0|-4.407|14.785|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||14.785|-4.407|
71856088|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.267|STANDARD_ERROR_OF_MEAN|4.828|||TWO_SIDED|95.0|-6.214|12.747|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||12.747|-6.214|
71856089|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|4.904|||TWO_SIDED|95.0|-5.61|13.65|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||13.650|-5.610|
71905623|NCT02720016|143333472|SUPERIORITY||Slope|-4.11|STANDARD_ERROR_OF_MEAN|1.308||0.002|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.002
71905624|NCT02720016|143333472|SUPERIORITY||Slope|-0.894|STANDARD_ERROR_OF_MEAN|1.296||0.492|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.492
71856090|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.753|STANDARD_ERROR_OF_MEAN|4.873|||TWO_SIDED|95.0|-8.816|10.322|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||10.322|-8.816|
71856091|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.986|STANDARD_ERROR_OF_MEAN|4.876|||TWO_SIDED|95.0|-6.589|12.561|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||12.561|-6.589|
71856092|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.916|STANDARD_ERROR_OF_MEAN|4.868|||TWO_SIDED|95.0|-4.643|14.475|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||14.475|-4.643|
71856093|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.432|STANDARD_ERROR_OF_MEAN|4.882|||TWO_SIDED|95.0|-2.154|17.019|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||17.019|-2.154|
71856094|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93|STANDARD_ERROR_OF_MEAN|4.909|||TWO_SIDED|95.0|-7.708|11.568|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||11.568|-7.708|
71856095|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.446|STANDARD_ERROR_OF_MEAN|4.854|||TWO_SIDED|95.0|-5.085|13.978|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||13.978|-5.085|
71856096|NCT01040403|143226132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|95.0|-7.046|12.079|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||12.079|-7.046|
71856097|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.212|STANDARD_ERROR_OF_MEAN|0.158|||TWO_SIDED|95.0|-0.523|0.099|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 1||0.099|-0.523|
71856098|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.319|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.634|-0.004|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 1||-0.004|-0.634|
71856099|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.379|0.249|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 1||0.249|-0.379|
71856100|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.107|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.42|0.206|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 1||0.206|-0.420|
71856101|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.168|0.462|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 1||0.462|-0.168|
71856102|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.255|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|95.0|-0.062|0.571|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 1||0.571|-0.062|
71856103|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.271|0.355|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 1||0.355|-0.271|
71856104|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.251|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.564|0.062|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 1||0.062|-0.564|
71856105|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.492|0.135|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 1||0.135|-0.492|
71856106|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.293|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|95.0|-0.611|0.024|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 1||0.024|-0.611|
71856107|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-0.533|0.092|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 1||0.092|-0.533|
71856108|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.242|0.388|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 1||0.388|-0.242|
71856109|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.241|0.462|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Week 4||0.462|-0.241|
71856110|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.092|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.445|0.261|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Week 4||0.261|-0.445|
71856111|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.301|0.406|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Week 4||0.406|-0.301|
71856112|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.555|0.15|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 4||0.150|-0.555|
71856113|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.411|0.296|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 4||0.296|-0.411|
71856114|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.208|0.496|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 4||0.496|-0.208|
71856115|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.217|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.568|0.135|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Week 4||0.135|-0.568|
71856116|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.714|-0.012|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Week 4||-0.012|-0.714|
71856117|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.246|STANDARD_ERROR_OF_MEAN|0.179|||TWO_SIDED|95.0|-0.598|0.106|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Week 4||0.106|-0.598|
71856118|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.146|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|95.0|-0.503|0.21|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 4||0.210|-0.503|
71856119|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.029|STANDARD_ERROR_OF_MEAN|0.178|||TWO_SIDED|95.0|-0.379|0.321|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 4||0.321|-0.379|
71856120|NCT01040403|143226136|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.235|0.47|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 4||0.470|-0.235|
71856121|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.223|0.25|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|Day 1||0.250|-0.223|
71856122|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.37|0.104|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 1||0.104|-0.370|
71856123|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.039|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|-0.278|0.199|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 1||0.199|-0.278|
71856124|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.382|0.088|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 1||0.088|-0.382|
71856125|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.291|0.186|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 1||0.186|-0.291|
71856126|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.144|0.332|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 1||0.332|-0.144|
71856127|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.282|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.519|-0.045|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 1||-0.045|-0.519|
71856128|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.113|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.35|0.124|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 1||0.124|-0.350|
71856129|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.056|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.293|0.18|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 1||0.180|-0.293|
71856130|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|-0.069|0.408|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 1||0.408|-0.069|
71856131|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.461|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 1||0.461|-0.010|
71856132|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.18|0.293|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 1||0.293|-0.180|
71856133|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.067|0.387|||Mixed Models Analysis||Difference calculated as T+O 1.25/ minus Olo 5|Day 29||0.387|-0.067|
71856134|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|0.034|0.491|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|Day 29||0.491|0.034|
71856135|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.118|||TWO_SIDED|95.0|-0.148|0.316|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|Day 29||0.316|-0.148|
71856136|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|-0.124|0.328|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 29||0.328|-0.124|
71856137|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.306|0.154|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 29||0.154|-0.306|
71681065|NCT03315455|142880885|SUPERIORITY||Difference in Adjusted Means|14.01||||0.0297|TWO_SIDED|95.0|1.44|26.59||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||26.59|1.44|0.0297
71681066|NCT03315455|142880888|SUPERIORITY||Difference in Adjusted Means|-3.46||||0.6165|TWO_SIDED|95.0|-17.23|10.31||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||10.31|-17.23|0.6165
71681067|NCT03315455|142880888|SUPERIORITY||Difference in Adjusted Means|-7.58||||0.2797|TWO_SIDED|95.0|-21.48|6.33||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||6.33|-21.48|0.2797
71681068|NCT03315455|142880890|SUPERIORITY||Difference in Adjusted Means|-0.05||||0.489|TWO_SIDED|95.0|-0.18|0.09||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm A.|||0.09|-0.18|0.4890
71681069|NCT03315455|142880890|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.2454|TWO_SIDED|95.0|-0.22|0.06||Not controlled for Type I error|ANCOVA|Means were adjusted for baseline score, treatment group, and treatment by baseline interaction term.|The difference in adjusted means was calculated as Arm C minus Arm B.|||0.06|-0.22|0.2454
71681070|NCT03030118|142880916|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||For the primary outcome (SLICC classification criteria count \[SLICC score\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.||||0.72
71681071|NCT03030118|142880917|SUPERIORITY|||||||0.81|||||||Regression, Cox|||Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.||||0.81
71856138|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.408|0.052|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 29||0.052|-0.408|
71856139|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.056|0.4|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|Day 29||0.400|-0.056|
71856140|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.171|0.285|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|Day 29||0.285|-0.171|
71856141|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.11|0.346|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|Day 29||0.346|-0.110|
71856142|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.115|STANDARD_ERROR_OF_MEAN|0.117|||TWO_SIDED|95.0|-0.345|0.115|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 29||0.115|-0.345|
71856143|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.281|0.173|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 29||0.173|-0.281|
71856144|NCT01040403|143226137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.116|||TWO_SIDED|95.0|-0.166|0.289|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 29||0.289|-0.166|
71856145|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.222|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.481|0.037|||Mixed Models Analysis||Difference calculated as T+O 1.25/5 minus Olo 5|||0.037|-0.481|
71856146|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.441|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.7|-0.182|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus Olo 5|||-0.182|-0.700|
71856147|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.409|0.111|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus Olo 5|||0.111|-0.409|
71856148|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.478|0.04|||Mixed Models Analysis||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|||0.040|-0.478|
71856149|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.189|0.335|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 1.25/5|||0.335|-0.189|
71856150|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|0.031|0.553|||Mixed Models Analysis||Difference calculated as T+O 5/5 minus T+O 2.5/5|||0.553|0.031|
71856151|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.382|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.641|-0.123|||Mixed Models Analysis||Difference calculated as T+O 1.25/10 minus Olo 10|||-0.123|-0.641|
71856152|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.132|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.39|0.127|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus Olo 10|||0.127|-0.390|
71856153|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.585|-0.067|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus Olo 10|||-0.067|-0.585|
71856154|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.133|||TWO_SIDED|95.0|-0.01|0.511|||Mixed Models Analysis||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|||0.511|-0.010|
71856155|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.202|0.314|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 1.25/10|||0.314|-0.202|
71856156|NCT01040403|143226138|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.194|STANDARD_ERROR_OF_MEAN|0.132|||TWO_SIDED|95.0|-0.453|0.065|||Mixed Models Analysis||Difference calculated as T+O 5/10 minus T+O 2.5/10|||0.065|-0.453|
71905625|NCT02720016|143333477|SUPERIORITY||Slope|-0.352|STANDARD_ERROR_OF_MEAN|2.172||0.872|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.872
71681072|NCT03030118|142880918|SUPERIORITY|||||||0.74|||||||Regression, Logistic|||"For the SLEDAI score, we combined responses to model the following groups:~* Score of 0 or 1~* Score of 2 or 3~* Score of 4, 6, or 8"||||0.74
71681073|NCT03030118|142880919|SUPERIORITY|||||||0.77|||||||Regression, Logistic|Ordinal logistic regression||"For analysis, we combined responses ≥3 to model the following groups:~* Score of 0~* Score of 1~* Score of 2~* Score of 3 or higher"||||0.77
71856157|NCT02973477|143226141|OTHER|Mixed effects model|Coefficient|0.28||||0.28|TWO_SIDED|95.0|-0.24|0.8||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted mixed models analysis for both periods, both arms, comparing each treatment's change.||0.8|-0.24|0.28
71856158|NCT02973477|143226142|OTHER||Coefficient|-0.003||||0.97|TWO_SIDED|95.0|-0.16|0.15||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for SDNN.||0.15|-0.16|0.97
71856159|NCT02973477|143226142|OTHER||Coefficient|-0.02||||0.79|TWO_SIDED|95.0|-0.21|0.16||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis to compare the difference between the values from baseline to 12 weeks between each intervention for rmsSD.||0.16|-0.21|0.79
71856160|NCT02973477|143226143|OTHER||Coefficient|0.01||||0.58|TWO_SIDED|95.0|-0.02|0.04||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of EI ratio.||0.04|-0.02|0.58
71856161|NCT02973477|143226143|OTHER||Coefficient|0.02||||0.58|TWO_SIDED|95.0|-0.05|0.09||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for Valsalva ratio.|Mixed Models Analysis||The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.|This is the adjusted analysis for both periods, both arms, comparing each treatment's change of Valsalva ratio.||0.09|-0.05|0.58
71856162|NCT02973477|143226143|OTHER||Coefficient|-0.01||||0.56|TWO_SIDED|95.0|-0.05|0.03||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for 30:15 ratio.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of 30:15 ratio.||0.03|-0.05|0.56
71856163|NCT02973477|143226144|OTHER||Coefficient|0.01||||0.92|TWO_SIDED|95.0|-0.23|0.25||Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.|Mixed Models Analysis|||This is the adjusted analysis for both periods, both arms, comparing each treatment's change of BNP.||0.25|-0.23|0.92
71856164|NCT03036150|143226149|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.0001||95.0|0.51|0.72|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.72|0.51|< 0.0001
71856165|NCT03036150|143226150|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.45|0.68|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.68|0.45|< 0.0001
71681074|NCT03030118|142880920|SUPERIORITY|||||||0.386|||||||t-test, 2 sided|Paired t-test||||||0.386
71856166|NCT03036150|143226151|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0089||95.0|0.55|0.92|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.92|0.55|0.0089
71681075|NCT03030118|142880921|SUPERIORITY|||||||0.497|||||||t-test, 2 sided|Paired t-test||||||0.497
71856167|NCT03036150|143226152|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0035||95.0|0.53|0.88|||Regression, Cox|Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.||||0.88|0.53|0.0035
71856168|NCT02487251|143226163|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.15||||0.34|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in BMIz is p = .34.|Mixed Models Analysis||The reported estimation parameter is the effect size (cohen's d) for the change in BMIz (particularly in the Phase 2 sample)|We tested change in BMIz for each of the four study arms/groups.||||.34
71856169|NCT02487251|143226164|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|-0.07||||0.62|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed fruit intake is p = .62.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in observed fruit intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups.||||.62
71681076|NCT03030118|142880922|SUPERIORITY|||||||0.99|||||||Regression, Logistic|Ordinal logistic regression||||||0.99
71681077|NCT03030118|142880923|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71681078|NCT03030118|142880924|NON_INFERIORITY|Outcome with hydroxychloroquine is hypothesized to be not inferior to outcome with placebo.|||||>|0.5|||||||Fisher Exact|||||||>0.5
71856170|NCT02487251|143226165|EQUIVALENCE|Sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in observed vegetable intake is p = .009.|Mixed Models Analysis|||We tested pre to post change in observed vegetable intake for each of the two study arms/groups in Phase 2 and compared change between the usual care and intervention groups. Positive Observed dietary quality data was not collected in Phase 1.||||.009
71856171|NCT02487251|143226166|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.15||||0.21|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported fruit is p = .21.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested pre to post change in parent reported child fruit intake for each of the four study arms/groups.||||.21
71856172|NCT02487251|143226167|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, enabled detection of small-medium effect sizes, d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes, power of 80%, α = .05. Phase 1 analyses included paired t-tests \& examination of pre-post effect size change. Phase 2 analyses included mixed modeling. Negative mean change values reflect a decrease in intake; positive values reflect an increase.|Mean Difference (Final Values)|0.07||||0.55|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in parent reported vegetables is p = .55.|Mixed Models Analysis||The reported estimation parameter is a standardized mean difference between the groups, specifically cohen's d.|We tested change in vegetable intake for each of the four study arms/groups.||||.55
71856173|NCT02487251|143226168|EQUIVALENCE|Phase 1 sought to determine effect sizes. For Phase 2, sample size was set at 125 per arm which, with 20% attrition, would enable detection of small to medium effect sizes of d = 0.40SD for continuous outcomes and 38% relative risk reduction for binary outcomes with a power of 80% and α = .05.|Mean Difference (Final Values)|-0.02||||0.84|TWO_SIDED|||||p \< .05 reflects the threshold for statistical significance. The calculated p value for change in mealtime frequency is p = .84.|Mixed Models Analysis|||We tested change in frequency of family mealtimes for each of the four study arms/groups.||||.84
71856174|NCT01037413|143226181|SUPERIORITY||Mean Difference (Final Values)|-14.7|||<|0.001|TWO_SIDED|95.0|-21.3|-8.1|||t-test, 2 sided|||Comparison within the participant between EXC 001 and placebo.||-8.1|-21.3|<0.001
71856175|NCT01037413|143226182|SUPERIORITY||Mean Difference (Final Values)|-14.8|||<|0.001|TWO_SIDED|95.0|-21.2|-8.3|||t-test, 2 sided|||Week 8: Comparison within the participant between EXC 001 and placebo.||-8.3|-21.2|<0.001
71856176|NCT01037413|143226182|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.001|TWO_SIDED|95.0|-34.3|-17.7|||t-test, 2 sided|||Week 24: Comparison within the participant between EXC 001 and placebo.||-17.7|-34.3|<0.001
71856177|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.033|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Vascularity: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.033
71856178|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.003|TWO_SIDED|95.0|-1.9|-0.4|||t-test, 2 sided|||Week 12, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.4|-1.9|0.003
71856179|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.5|-0.8|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.5|<0.001
71856180|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.7|-1.0|||t-test, 2 sided|||Week 12, Relief: Comparison within the participant between EXC 001 and placebo.||-1.0|-2.7|<0.001
71905626|NCT02720016|143333477|SUPERIORITY||Slope|-0.931|STANDARD_ERROR_OF_MEAN|2.296||0.686|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.686
71905627|NCT02720016|143333477|SUPERIORITY||Slope|-0.579|STANDARD_ERROR_OF_MEAN|2.256||0.798|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts and included partners nested within couples||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.798
71905628|NCT02720016|143333482|SUPERIORITY||Slope|-1.213|STANDARD_ERROR_OF_MEAN|2.518||0.631|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.631
71905629|NCT02720016|143333482|SUPERIORITY||Slope|-1.461|STANDARD_ERROR_OF_MEAN|2.495||0.56|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.560
71681079|NCT03030118|142880925|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71856181|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.012|TWO_SIDED|95.0|-1.9|-0.3|||t-test, 2 sided|||Week 12, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.3|-1.9|0.012
71856182|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.003|TWO_SIDED|95.0|-2.4|-0.5|||t-test, 2 sided|||Week 12, Surface Area: Comparison within the participant between EXC 001 and placebo.||-0.5|-2.4|0.003
71856183|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.6|-1.1|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.1|-2.6|<0.001
71681080|NCT03030118|142880926|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71905630|NCT02720016|143333482|SUPERIORITY||Slope|-0.248|STANDARD_ERROR_OF_MEAN|2.536||0.922|TWO_SIDED||||||Mixed-effects regression|Models included random intercepts||Analyses were pooled across 50 imputed data sets. We used piecewise/spline mixed-effects regression models: one slope estimated from baseline to post (treatment impacts), with a separate slope estimated from post to 6-months (maintenance).||||.922
71905631|NCT00186056|143333510|SUPERIORITY_OR_OTHER||||||<|0.26|||||||ANOVA|Interaction of HAMD \* medication group F(2,26)=1.38, eta sq = .05||||||<.26
71905632|NCT04465396|143333524|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.22|||||TWO_SIDED|90.0|104.83|113.8|||||The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.|||113.80|104.83|
71905633|NCT04465396|143333524|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|113.99|||||TWO_SIDED|90.0|108.32|119.95|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||119.95|108.32|
71905634|NCT04465396|143333525|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|98.27|||||TWO_SIDED|90.0|88.5|109.11|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||109.11|88.50|
71681081|NCT00480493|142880941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|3.36||0.468|TWO_SIDED|95.0|-4.32|9.24|||t-test, 2 sided||Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.||9.24|-4.32|0.468
71905635|NCT04465396|143333525|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|92.48|||||TWO_SIDED|90.0|83.8|102.05|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||102.05|83.80|
71905636|NCT04465396|143333526|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|109.44|||||TWO_SIDED|90.0|105.51|113.51|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||113.51|105.51|
71681082|NCT00480493|142880942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.82|STANDARD_ERROR_OF_MEAN|10.05||0.634|TWO_SIDED|95.0|-15.47|25.11|||t-test, 2 sided||Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.||25.11|-15.47|0.634
71681083|NCT00480493|142880943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.48|STANDARD_ERROR_OF_MEAN|3.12||0.43|TWO_SIDED|95.0|-8.76|3.8|||t-test, 2 sided||We also used a random-effect, mixed regression models to look for between group changes over time.|The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.||3.80|-8.76|0.430
71856184|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-8.4|||<|0.001|TWO_SIDED|95.0|-12.7|-4.0|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||-4.0|-12.7|<0.001
71856185|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED|95.0|-3.2|-1.4|||t-test, 2 sided|||Week 24, Vascularity: Comparison within the participant between EXC 001 and placebo.||-1.4|-3.2|<0.001
71856186|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.9|-0.9|||t-test, 2 sided|||Week 24, Pigmentation: Comparison within the participant between EXC 001 and placebo.||-0.9|-2.9|<0.001
71856187|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.001|TWO_SIDED|95.0|-2.8|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-2.8|0.001
71856188|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.6|-1.3|||t-test, 2 sided|||Week 24, Relief: Comparison within the participant between EXC 001 and placebo.||-1.3|-3.6|<0.001
71856189|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.005|TWO_SIDED|95.0|-3.2|-0.7|||t-test, 2 sided|||Week 24, Pliability: Comparison within the participant between EXC 001 and placebo.||-0.7|-3.2|0.005
71856190|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-2.2|||<|0.001|TWO_SIDED|95.0|-3.1|-1.2|||t-test, 2 sided|||Week 24, Surface Area: Comparison within the participant between EXC 001 and placebo.||-1.2|-3.1|<0.001
71856191|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.3|-1.5|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-1.5|-3.3|<0.001
71856192|NCT01037413|143226183|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED|95.0|-17.7|-7.4|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-7.4|-17.7|<0.001
71856193|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.067|TWO_SIDED|95.0|-1.3|0.0|||t-test, 2 sided|||Week 12 Pain: Comparison within the participant between EXC 001 and placebo.||0.0|-1.3|0.067
71856194|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.413|TWO_SIDED|95.0|-1.2|0.5|||t-test, 2 sided|||Week 12, Itching: Comparison within the participant between EXC 001 and placebo.||0.5|-1.2|0.413
71856195|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.401|TWO_SIDED|95.0|-1.6|0.7|||t-test, 2 sided|||Week 12, Color: Comparison within the participant between EXC 001 and placebo.||0.7|-1.6|0.401
71856196|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.083|TWO_SIDED|95.0|-2.4|0.2|||t-test, 2 sided|||Week 12, Stiffness: Comparison within the participant between EXC 001 and placebo.||0.2|-2.4|0.083
71681084|NCT01032070|142880944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||95.0||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||The study was not powered for this comparison due to small sample size.||||0.2200
71856197|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.052|TWO_SIDED|95.0|-2.3|0.0|||t-test, 2 sided|||Week 12, Thickness: Comparison within the participant between EXC 001 and placebo.||0.0|-2.3|0.052
71856198|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.036|TWO_SIDED|95.0|-2.3|-0.1|||t-test, 2 sided|||Week 12, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.1|-2.3|0.036
71856199|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.045|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||Week 12, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.0|-2.1|0.045
71856200|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.054|TWO_SIDED|95.0|-9.9|0.1|||t-test, 2 sided|||Week 12, Composite Score: Comparison within the participant between EXC 001 and placebo.||0.1|-9.9|0.054
71856201|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.065|TWO_SIDED|95.0|-8.2|0.3|||t-test, 2 sided|||Week 12, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||0.3|-8.2|0.065
71856202|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.079|TWO_SIDED|95.0|-2.0|0.1|||t-test, 2 sided|||Week 24, Pain: Comparison within the participant between EXC 001 and placebo.||0.1|-2.0|0.079
71856203|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.158|TWO_SIDED|95.0|-1.5|0.3|||t-test, 2 sided|||Week 24, Itching: Comparison within the participant between EXC 001 and placebo.||0.3|-1.5|0.158
71856204|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.01|TWO_SIDED|95.0|-3.0|-0.5|||t-test, 2 sided|||Week 24, Color: Comparison within the participant between EXC 001 and placebo.||-0.5|-3.0|0.010
71856205|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.003|TWO_SIDED|95.0|-3.5|-0.8|||t-test, 2 sided|||Week 24, Stiffness: Comparison within the participant between EXC 001 and placebo.||-0.8|-3.5|0.003
71856206|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.005|TWO_SIDED|95.0|-4.0|-0.8|||t-test, 2 sided|||Week 24, Thickness: Comparison within the participant between EXC 001 and placebo.||-0.8|-4.0|0.005
71856207|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.032|TWO_SIDED|95.0|-3.5|-0.2|||t-test, 2 sided|||Week 24, Irregular: Comparison within the participant between EXC 001 and placebo.||-0.2|-3.5|0.032
71856208|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.003|TWO_SIDED|95.0|-3.8|-0.9|||t-test, 2 sided|||Week 24, Overall Opinion: Comparison within the participant between EXC 001 and placebo.||-0.9|-3.8|0.003
71856209|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-9.8||||0.006|TWO_SIDED|95.0|-16.4|-3.1|||t-test, 2 sided|||Week 24, Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.1|-16.4|0.006
71856210|NCT01037413|143226184|SUPERIORITY||Mean Difference (Final Values)|-8.2||||0.004|TWO_SIDED|95.0|-13.4|-3.0|||t-test, 2 sided|||Week 24, Scar Appearance Composite Score: Comparison within the participant between EXC 001 and placebo.||-3.0|-13.4|0.004
71856211|NCT00619983|143226192|SUPERIORITY|||||||0.69|||||||ANOVA|Repeated measures ANOVA||Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit \< 30% of the number of subjects required in our power analysis.||||0.69
71856212|NCT00570921|143226203|SUPERIORITY_OR_OTHER||Median Time to Progression|7.4|||||TWO_SIDED|95.0|1.9|12.1||||||We hypothesized that median time to progression (TTP) in our trial will increase from 3.7 months for the historical fulvestrant-only control to 7.0 months on the combination of fulvestrant and everolimus in the current trial. A sample of 40 evaluable patients was calculated to show the increase in TTP with 80% power and 5% significance level based on a two sided test of differences in survival times between historical controls and treated group.||12.1|1.9|
71856213|NCT00570921|143226204|SUPERIORITY_OR_OTHER||Response Rate Percentage|12.9|||||TWO_SIDED|95.0|3.63|29.83|||||Percentage of Patients with a complete or partial response with 95% exact binomial proportion confidence interval|||29.83|3.63|
71856214|NCT00570921|143226205|SUPERIORITY_OR_OTHER||Percentage with clinical benefit|48.39|||||TWO_SIDED|95.0|30.15|66.94|||||Percentage of patients that had a complete response, partial response, or stable disease for 24 weeks or more as defined by RECIST v1.0.|||66.94|30.15|
71905637|NCT04465396|143333526|EQUIVALENCE|Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.|Geometric Mean Ratio|118.4|||||TWO_SIDED|90.0|112.31|124.83|||||The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.|||124.83|112.31|
71905638|NCT00547638|143333540|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of DERMABOND HVD successful subjects) does not exceed 8%.|Difference in Proportion of Successes|-7.9|||||TWO_SIDED|95.0|-17.7|1.0|||Gart-Nam||The value for the Estimated Parameter is expressed as a percentage and is defined as the difference in the proportion of sucesses between study groups.|||1.0|-17.7|
71856215|NCT00784277|143226211|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|55.1|STANDARD_ERROR_OF_MEAN|20.37||0.007||95.0|15.11|95.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||95.13|15.11|0.007
71905639|NCT00547638|143333541|SUPERIORITY_OR_OTHER|||||||0.457||||||The total mHCS scores are summarized as proportion of subjects with good outcome (total scores of zero) and a comparison of treatment groups by Fisher Exact Test was performed to confirm differences in groups.|Fisher Exact|||||||0.457
71681085|NCT00738062|142880958|SUPERIORITY_OR_OTHER|||||||0.438|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.438
71856216|NCT00784277|143226211|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|63.4|STANDARD_ERROR_OF_MEAN|20.23||0.004||95.0|23.67|103.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||103.13|23.67|0.004
71856217|NCT00784277|143226212|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|3.1|STANDARD_ERROR_OF_MEAN|0.46|<|0.001||95.0|2.22|4.01||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||4.01|2.22|<0.001
71856218|NCT00784277|143226212|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|2.2|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|1.34|3.12||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||3.12|1.34|<0.001
71856219|NCT00784277|143226212|SUPERIORITY_OR_OTHER||Difference in Least-Squares Means|1.6|STANDARD_ERROR_OF_MEAN|0.45|<|0.001||95.0|0.72|2.5||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.|||2.50|0.72|<0.001
71856220|NCT00999141|143226221|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||two-sided paired t-test|alpha = 5%||||||<0.0001
71856221|NCT00999141|143226224|SUPERIORITY_OR_OTHER||Difference in Proportions|0.04||||0.257||95.0|-0.039|0.125|||McNemar|alpha = 5%|Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||0.125|-0.039|0.257
71856222|NCT00999141|143226225|SUPERIORITY_OR_OTHER||Difference in proportions|-0.373|||<|0.001||95.0|-0.524|-0.193|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.193|-0.524|<0.001
71856223|NCT00999141|143226226|SUPERIORITY_OR_OTHER||Difference in proportions|-0.387|||<|0.001||95.0|-0.538|-0.205|||McNemar||Difference in Proportions = SoC - FS VH S/D 4 s-apr|||-0.205|-0.538|<0.001
71856224|NCT00999141|143226227|SUPERIORITY_OR_OTHER||Difference in proportions|-0.356||||0.001||95.0|-0.521|-0.161|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.161|-0.521|0.001
71856225|NCT00999141|143226228|SUPERIORITY_OR_OTHER||Difference in proportions|-0.189||||0.027||95.0|-0.342|-0.023|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr|||-0.023|-0.342|0.027
71856226|NCT00999141|143226231|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.413||||||95.0|-0.577|-0.213|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.213|-0.577|
71856227|NCT00999141|143226232|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.227||||||95.0|-0.413|-0.02|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.020|-0.413|
71856228|NCT00999141|143226233|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.347||||||95.0|-0.518|-0.145|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.145|-0.518|
71856229|NCT00999141|143226234|SUPERIORITY_OR_OTHER||Difference in Proportions|-0.365||||||95.0|-0.528|-0.171|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)|||-0.171|-0.528|
71856230|NCT00413634|143226244|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||ANOVA|||||||0.092
71856231|NCT00413634|143226247|SUPERIORITY_OR_OTHER_LEGACY|||||||0.857||95.0|||||ANOVA|||||||0.857
71856232|NCT00413634|143226248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
71856233|NCT00413634|143226249|SUPERIORITY_OR_OTHER_LEGACY|||||||0.378||95.0|||||ANOVA|||||||0.378
71856234|NCT00413634|143226250|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||95.0|||||ANOVA|||||||0.013
71856235|NCT00413634|143226251|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035||95.0|||||ANOVA|||||||0.035
71856236|NCT00413634|143226252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0|||||ANOVA|||||||0.023
71856237|NCT00413634|143226253|SUPERIORITY_OR_OTHER_LEGACY|||||||0.557||95.0|||||ANOVA|||||||0.557
71856238|NCT00413634|143226254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
71856239|NCT00413634|143226255|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||ANOVA|||||||0.007
71856240|NCT00413634|143226256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||95.0|||||ANOVA|||||||0.027
71856241|NCT00413634|143226257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011||95.0|||||ANOVA|||||||0.011
71856242|NCT02101268|143226300|SUPERIORITY||Proportion Difference - Stratified CMH|0.01||||0.9|TWO_SIDED|95.0|-0.09|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.09|0.90
71856243|NCT02101268|143226301|SUPERIORITY||Proportion Difference - Stratified CMH|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||||0.32|0.09|< 0.001
71905640|NCT00547638|143333542|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 14 and Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
71856244|NCT02101268|143226302|SUPERIORITY||Rate ratio|0.8||||0.38|TWO_SIDED|95.0|0.49|1.31|||Negative Binomial Model, Adjusted||A smaller ratio represents larger benefit.|||1.31|0.49|0.38
71856245|NCT02101268|143226303|SUPERIORITY||Proportion Difference - Stratified CMH|0.23||||0.001|TWO_SIDED|95.0|0.09|0.37|||Cochran-Mantel-Haenszel||A larger proportion represents larger benefit.|||0.37|0.09|0.001
71856246|NCT02101268|143226304|SUPERIORITY||Proportion Difference - Stratified CMH|-0.13||||0.1|TWO_SIDED|95.0|-0.29|0.03|||Cochran-Mantel-Haenszel||A smaller proportion represents larger benefit.|||0.03|-0.29|0.10
71856247|NCT00740870|143226305|SUPERIORITY||Kaplan-Meier Rate|74.2|||<|0.0001|ONE_SIDED|95.0|67.1||||Z test||||||67.1|<0.0001
71856248|NCT02831998|143226321|NON_INFERIORITY|Investigational product upper bounds must be less than 0.5.|Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.188|0.083||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.083|-0.188|
71681086|NCT00738062|142880959|SUPERIORITY_OR_OTHER|||||||0.554|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.||||||0.554
71681087|NCT00738062|142880960|SUPERIORITY_OR_OTHER|||||||0.198|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.||||||0.198
71856249|NCT02831998|143226321|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Median Difference (Final Values)|2.627|||||TWO_SIDED|95.0|2.396|2.858||||||Groin 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.858|2.396|
71856250|NCT02831998|143226322|NON_INFERIORITY|Investigational product average treatment effect upper bounds cannot be more than 0.5.|Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.102|0.065||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||0.065|-0.102|
71856251|NCT02831998|143226322|SUPERIORITY|Investigational product lower bounds must be greater than 1.2.|Mean Difference (Final Values)|1.909|||||TWO_SIDED|95.0|1.766|2.053||||||Abdomen 10 minutes Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\^2 bacterial counts as a covariate.||2.053|1.766|
71856252|NCT00839332|143226324|SUPERIORITY_OR_OTHER||Bayesian Posterior Probability|0.333|||||TWO_SIDED||||||||Inference about survival was made using a Bayesian posterior probability. The combination treatment would have been considered superior to gemcitabine alone if the posterior probability of superiority exceeded 0.8.|||||
71856253|NCT03569475|143226342|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.41||0.2215|TWO_SIDED|95.0|-4.49|1.04|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||1.04|-4.49|0.2215
71856254|NCT03569475|143226342|SUPERIORITY||Least Square Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.41||0.1964|TWO_SIDED|95.0|-4.59|0.95|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.95|-4.59|0.1964
71905641|NCT00547638|143333542|SUPERIORITY_OR_OTHER|||||||1||95.0||||Differences between treatment groups in the incidence rate of infection at Day 30 were compared using the Fisher's Exact Test.|Fisher Exact|||||||1.0000
71905642|NCT00547638|143333543|SUPERIORITY_OR_OTHER|||||||0.188||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.188
71905643|NCT00547638|143333543|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Intent to treat population was analyzed.|Fisher Exact|||||||0.883
71681088|NCT00738062|142880961|SUPERIORITY_OR_OTHER|||||||0.286|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.286
71681089|NCT00738062|142880962|SUPERIORITY_OR_OTHER|||||||0.251|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.||||||0.251
71681090|NCT00738062|142880963|SUPERIORITY_OR_OTHER|||||||0.708|||||||Fisher Exact|||||||0.708
71681091|NCT00738062|142880964|SUPERIORITY_OR_OTHER|||||||0.873|||||||Fisher Exact|||||||0.873
71681092|NCT00738062|142880965|SUPERIORITY_OR_OTHER|||||||0.252|||||||Fisher Exact|||||||0.252
71681093|NCT00738062|142880966|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||||||0.330
71681094|NCT00426660|142880986|SUPERIORITY_OR_OTHER||75th percentile (median)|169.0|||||TWO_SIDED|95.0|135.0|178.0||||||||178.0|135.0|
71856255|NCT03569475|143226343|SUPERIORITY||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.6789|TWO_SIDED|95.0|-0.32|0.21|||Mixed Model for Repeated Measures||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and Baseline and Baseline-by-visit as covariates using an unstructured covariance matrix.|||0.21|-0.32|0.6789
71856256|NCT03569475|143226343|SUPERIORITY||Least Square Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1126|TWO_SIDED|95.0|-0.48|0.05|||Mixed Model for Repeated Measures|||||0.05|-0.48|0.1126
71856257|NCT03638258|143226349|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward (LOCF) where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||<0.001
71856258|NCT03638258|143226349|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpolation was not computationally possible.||||||0.004|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||||||0.004
71856259|NCT03638258|143226350|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.015
71856260|NCT03638258|143226350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.174|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from placebo at Week 4||||0.174
71856261|NCT03638258|143226350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
71856262|NCT03638258|143226350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.001
71856263|NCT03638258|143226350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||<0.001
71681095|NCT00426660|142880986|SUPERIORITY_OR_OTHER||50th percentile (median)|86.5|||||TWO_SIDED|95.0|82.0|92.0||||||||92.0|82.0|
71856264|NCT03638258|143226350|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.008
71856265|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
71856266|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 4||||<0.001
71856267|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
71856268|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 6||||<0.001
71856269|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.x|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
71856270|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 8||||<0.001
71905644|NCT00547638|143333544|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
71681096|NCT00426660|142880986|SUPERIORITY_OR_OTHER||25th percentile (median)|58.0|||||TWO_SIDED|95.0|57.0|62.0||||||||62.0|57.0|
71681097|NCT00550862|142880991|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
71681098|NCT00550862|142880991|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals.||||<0.0001
71856271|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
71856272|NCT03638258|143226351|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline mPASI score.||Difference from vehicle cream at Week 12||||<0.001
71856273|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream on Week 4||||<0.001
71856274|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 4||||<0.001
71856275|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
71856276|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 6||||<0.001
71856277|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 8||||<0.001
71856278|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 8||||<0.001
71856279|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle at Week 12||||<0.001
71856280|NCT03638258|143226352|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline BSA score.||Difference from vehicle cream at Week 12||||<0.001
71856281|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.116|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.116
71856282|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.423|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 4||||0.423
71856283|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.002
71856284|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.038|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 6||||0.038
71905645|NCT05027516|143333550|SUPERIORITY||Ratio|1.05||||0.1026|TWO_SIDED|95.0|0.55|1.83|||Permutation testing|||||1.83|0.55|0.1026
71905646|NCT05027516|143333551|SUPERIORITY||Ratio|1.12||||1|TWO_SIDED|95.0|0.47|2.19|||Permutation testing|||For aminoglycosides||2.19|0.47|1
71856285|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||<0.001
71856286|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.005|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 8||||0.005
71856287|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.002
71856288|NCT03638258|143226353|SUPERIORITY|Missing data imputed using linear interpolation and last observation carried forward where linear interpolation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline IGA score.||Difference from vehicle cream at Week 12||||0.013
71856289|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.086|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference form vehicle cream at Week 4||||0.086
71905647|NCT05027516|143333551|SUPERIORITY||Ratio|1.01||||1|TWO_SIDED|95.0|0.69|1.44|||Permutation testing|||For betalactams||1.44|0.69|1
71905648|NCT05027516|143333551|SUPERIORITY||Ratio|3.79||||1|TWO_SIDED|95.0|0.05|20.15|||Permutation testing|||For bacitracin||20.15|0.05|1
71905649|NCT05027516|143333551|SUPERIORITY||Ratio|0.83||||1|TWO_SIDED|95.0|0.0|1.91|||Permutation testing|||For glycopeptides||1.91|0|1
71905650|NCT05027516|143333551|SUPERIORITY||Ratio|1.19||||1|TWO_SIDED|95.0|0.32|3.15|||Permutation testing|||For trimethoprim||3.15|0.32|1
71905651|NCT05027516|143333551|SUPERIORITY||Ratio|2.82||||1|TWO_SIDED|95.0|0.07|14.64|||Permutation testing|||For cationic antimicrobial peptides||14.64|0.07|1
71856290|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.123|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 4||||0.123
71681099|NCT00550862|142880991|OTHER||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied and pairwise comparisons of the 10mg treatment group versus the placebo group, then 25 mg and 50 mg were performed.||All tests: Descriptive methods were used with nominal p values provided and 95% confidence intervals||||<0.0001
71856291|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.017|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.017
71856292|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.415|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 6||||0.415
71856293|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.007|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.007
71856294|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.175|||||||Regression, Linear|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 8||||0.175
71856295|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle at Week 12||||0.001
71856296|NCT03638258|143226354|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.619|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline I-IGA score.||Difference from vehicle cream at Week 12||||0.619
71856297|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||<0.001
71856298|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
71681100|NCT00550862|142880992|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71681101|NCT00550862|142880993|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0005
71681102|NCT00980174|142881029|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8|||<|0.0001|TWO_SIDED|95.0|4.0|5.6|||ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||5.6|4.0|<0.0001
71856299|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
71856300|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||<0.001
71856301|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
71856302|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||<0.001
71856303|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
71856304|NCT03638258|143226355|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
71856305|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.002
71856306|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.203|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 4||||0.203
71856307|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.034|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.034
71856308|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.012|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 6||||0.012
71856309|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.010
71905652|NCT05027516|143333551|SUPERIORITY||Ratio|1.49||||1|TWO_SIDED|95.0|0.0|5.34|||Permutation testing|||For mupirocin||5.34|0|1
71905653|NCT05027516|143333551|SUPERIORITY||Ratio|1.2||||1|TWO_SIDED|95.0|0.0|3.22|||Permutation testing|||For metronidazole||3.22|0|1
71905654|NCT05027516|143333551|SUPERIORITY||Ratio|6.44||||1|TWO_SIDED|95.0|0.02|46.02|||Permutation testing|||For fluoroquinolones||46.02|0.02|1
71905655|NCT05027516|143333551|SUPERIORITY||Ratio|10.6||||1|TWO_SIDED|95.0|0.01|148.86|||Permutation testing|||For sulfonamides||148.86|0.01|1
71905656|NCT05027516|143333551|SUPERIORITY||Ratio|1.01||||0.5621|TWO_SIDED|95.0|0.79|1.27|||Permutation testing|||For tetracyclines||1.27|0.79|0.5621
71681103|NCT00980174|142881030|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|||<|0.0001|TWO_SIDED|95.0|1.5|2.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||2.6|1.5|<0.0001
71856310|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.075|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 8||||0.075
71856311|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
71856312|NCT03638258|143226356|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||Regression, Logistic|Logistic regression with a factor of treatment group and a covariate of baseline WI-NRS score.||Difference from vehicle cream at Week 12||||<0.001
71856313|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.527|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.527
71856314|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.444|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.444
71856315|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.006|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.006
71856316|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.013
71856317|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.002
71856318|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.064|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.064
71856319|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.002
71856320|NCT03638258|143226357|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
71856321|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.188|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.188
71905657|NCT05027516|143333552|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.196
71905658|NCT05027516|143333552|SUPERIORITY|||||||0.568|||||||Wilcoxon (Mann-Whitney)|||For streptococci||||0.568
71905659|NCT05027516|143333552|SUPERIORITY|||||||0.978|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.978
71905660|NCT05027516|143333552|SUPERIORITY|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||For Neisseria||||0.184
71905661|NCT03655717|143333553|SUPERIORITY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.259|0.184||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.184|-0.259|0.94
71856322|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.577|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 4||||0.577
71856323|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.008|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.008
71856324|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.664|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 6||||0.664
71856325|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.015|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.015
71856326|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.666|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 8||||0.666
71856327|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.009|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.009
71856328|NCT03638258|143226358|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.163|||||||Regression, Logistic|Logistic regression (Firth's penalized likelihood) with a factor of treatment group and a covariate of baseline PASI score.||Difference from vehicle cream at Week 12||||0.163
71856329|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||||||0.002|||||||ANOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream on Week 4||||0.002
71856330|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.002|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 4||||0.002
71856331|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 6||||<0.001
71856332|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 6||||<0.001
71856333|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from placebo at Week 8||||<0.001
71856334|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 8||||<0.001
71856335|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
71856336|NCT03638258|143226359|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline PSD score.||Difference from vehicle cream at Week 12||||<0.001
71921943|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-11.8|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||1.2|-11.8|
71856337|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.184|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss score.||Difference from vehicle cream at Week 4||||0.184
71681104|NCT00980174|142881031|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|||<|0.0001|TWO_SIDED|95.0|1.3|3.0||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.0|1.3|<0.0001
71856338|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.207|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from placebo at Week 4||||0.207
71856339|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.004|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.004
71856340|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.022|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 6||||0.022
71856341|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||0.003
71905662|NCT03655717|143333553|SUPERIORITY||Mean Difference (Final Values)|-0.018|STANDARD_ERROR_OF_MEAN|0.206||0.94|TWO_SIDED|95.0|-0.421|0.386||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.386|-0.421|0.94
71856342|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.|||||<|0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 8||||<0.001
71905663|NCT03655717|143333553|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.281||0.94|TWO_SIDED|95.0|-0.535|0.568||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.568|-0.535|0.94
71921944|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-14.2|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||3.5|-14.2|
71681105|NCT00980174|142881032|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.0001|TWO_SIDED|95.0|1.4|3.2||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||3.2|1.4|<0.0001
71681106|NCT00980174|142881033|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.9||||0.0144|TWO_SIDED|95.0|0.2|1.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo|||1.6|0.2|0.0144
71681107|NCT00980174|142881034|SUPERIORITY_OR_OTHER||||||<|0.0001||||||p-value is adjusted for multiple comparisons by Hochberg method|Van Elteren Rank Test|Adjusted by level of baseline bone mineral density T-score||||||<0.0001
71856343|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible. ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||||||0.003|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.||Difference from vehicle cream at Week 12||||0.003
71856344|NCT03638258|143226360|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.01||||||ANCOVA with a factor of treatment group and a covariate of baseline Itch-Related Sleep Loss NRS score.|ANCOVA|||Difference from vehicle cream at Week 12||||0.01
71856345|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.255|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 4||||0.255
71856346|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.687|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream on Week 4||||0.687
71856347|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.045|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.045
71856348|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.059|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 6||||0.059
71856349|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.051|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.051
71856350|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.013|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 8||||0.013
71856351|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.036|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.036
71856352|NCT03638258|143226361|SUPERIORITY|Missing data imputed using linear interpolation and LOCF where linear interpretation was not computationally possible.||||||0.001|||||||ANCOVA|ANCOVA with a factor of treatment group and a covariate of baseline DLQI score.||Difference from vehicle cream at Week 12||||0.001
71856353|NCT02630706|143226363|SUPERIORITY|Constrained longitudinal data analysis (cLDA)|Difference in the LSM vs. placebo|-0.69|||<|0.001|TWO_SIDED|95.0|-0.85|-0.52||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|Least squares means = LSM||The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo.||-0.52|-0.85|<0.001
71856354|NCT02630706|143226363|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.8|||<|0.001|TWO_SIDED|95.0|-0.97|-0.63|||cLDA|||The primary hypothesis of the study was the mean change from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo.||-0.63|-0.97|<0.001
71856355|NCT02630706|143226364|SUPERIORITY||Difference in the LSM vs. placebo|-0.68|||<|0.001|TWO_SIDED|95.0|-0.86|-0.5||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|||||-0.50|-0.86|<0.001
71856356|NCT02630706|143226364|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.76|||<|0.001|TWO_SIDED|95.0|-0.95|-0.58|||cLDA|||||-0.58|-0.95|<0.001
71856357|NCT02630706|143226365|OTHER||Difference in % vs. Placebo|-6.0|||||TWO_SIDED|95.0|-16.5|4.6|||||||Miettinen-Nurminen method|4.6|-16.5|
71856358|NCT02630706|143226365|OTHER||Difference in % vs. Placebo|-2.8|||||TWO_SIDED|95.0|-13.3|7.7|||||||Miettinen-Nurminen method|7.7|-13.3|
71856359|NCT02630706|143226366|OTHER||Difference in % vs. Placebo|-8.9|||||TWO_SIDED|95.0|-20.5|3.0|||||||Miettinen-Nurminen method|3.0|-20.5|
71856360|NCT02630706|143226366|OTHER||Difference in % vs. Placebo|-4.8|||||TWO_SIDED|95.0|-16.5|6.9|||||||Miettinen-Nurminen method|6.9|-16.5|
71856361|NCT02630706|143226369|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-27.78|||<|0.001|TWO_SIDED|95.0|-33.85|-21.7|||cLDA|||||-21.70|-33.85|<0.001
71856362|NCT02630706|143226369|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-30.4|||<|0.001|TWO_SIDED|95.0|-36.45|-24.35|||cLDA|||||-24.35|-36.45|<0.001
71856363|NCT02630706|143226370|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-26.21|||<|0.001|TWO_SIDED|95.0|-32.41|-20.01|||cLDA|||||-20.01|-32.41|<0.001
71856364|NCT02630706|143226370|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-28.55|||<|0.001|TWO_SIDED|95.0|-34.67|-22.43|||cLDA|||||-22.43|-34.67|<0.001
71856365|NCT02630706|143226371|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.0|||<|0.001|TWO_SIDED|95.0|-2.51|-1.5|||cLDA|||||-1.50|-2.51|<0.001
71856366|NCT02630706|143226371|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.78|||<|0.001|TWO_SIDED|95.0|-2.28|-1.28|||cLDA|||||-1.28|-2.28|<0.001
71856367|NCT02630706|143226372|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.05|||<|0.001|TWO_SIDED|95.0|-2.63|-1.21|||cLDA|||||-1.21|-2.63|<0.001
71856368|NCT02630706|143226372|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.79|||<|0.001|TWO_SIDED|95.0|-2.36|-1.21|||cLDA|||||-1.21|-2.36|<0.001
71856369|NCT02630706|143226373|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.56|||<|0.001|TWO_SIDED|95.0|2.49|8.35|||Logistic regression model|||||8.35|2.49|<0.001
71856370|NCT02630706|143226373|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.59|||<|0.001|TWO_SIDED|95.0|2.52|8.36|||Logistic regression model|||||8.36|2.52|<0.001
71856371|NCT02630706|143226374|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.49|||<|0.001|TWO_SIDED|95.0|2.32|8.68|||Logistic regression model|||||8.68|2.32|<0.001
71856372|NCT02630706|143226374|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|3.47|||<|0.001|TWO_SIDED|95.0|1.77|6.8|||Logistic regression model|||||6.80|1.77|<0.001
71905664|NCT03655717|143333554|SUPERIORITY||Mean Difference (Final Values)|-0.163|STANDARD_ERROR_OF_MEAN|0.113||0.94|TWO_SIDED|95.0|-0.384|0.057||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for dronabinol conditions (positive values denote higher HbO levels for post-dronabinol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with dronabinol (i.e., a main effect for dronabinol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.057|-0.384|0.94
71905665|NCT03655717|143333554|SUPERIORITY||Mean Difference (Final Values)|-0.176|STANDARD_ERROR_OF_MEAN|0.21||0.94|TWO_SIDED|95.0|-0.588|0.237||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for ethanol conditions (positive values denote higher HbO levels for post-ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with ethanol (i.e., a main effect for ethanol dose), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.237|-0.588|0.94
71905666|NCT03655717|143333554|SUPERIORITY||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.276||0.94|TWO_SIDED|95.0|-0.354|0.728||The p-value is adjusted for multiple comparisons using the Benjamini-Hochberg method across the two primary outcome measures and six contrasts. Effects were deemed significant for p\<0.05.|Regression, Linear|Estimates for p-values were obtained via a non-parametric resampling approach randomly shuffling condition and refitting the data 10,000 times.|Estimate is the mean difference in average HbO level between pre-dose scans and post-dose scans for the dronabinol + ethanol condition (positive values denote higher HbO levels for post-dronabinol+ethanol scans).|The mean difference in average HbO levels (converted to z-scores) between the pre and post-dose scans for conditions where a participant was dosed with both dronabinol and ethanol (i.e., the interaction between dronabinol and ethanol doses), estimated via a linear model with with a subject-varying intercept and covariates for (a) overall differences between pre and post-dose scans and (b) visit order.||0.728|-0.354|0.94
71681108|NCT01683422|142881037|SUPERIORITY|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.||||||0.1|||||||t-test, 1 sided|||In the RTOG 9812 (NCT00003591) for unresectable pancreatic cancer, a one-year survival rate of 43% was observed. There were 109 analyzable patients on NCT00003591 with 61 still at risk for death at one year. Using the method of Dixon and Simon, a sample size of 39 analyzable patients followed over 12 months will ensure at least 90% probability of detecting a minimum of 17% improvement in the one-year survival rate compared to NCT00003591 at the 0.10 significance level (with a one-sided test).||||0.1
71856373|NCT02630706|143226375|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.09|||<|0.001|TWO_SIDED|95.0|-6.48|-1.69|||cLDA|||||-1.69|-6.48|<0.001
71856374|NCT02630706|143226375|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-5.3|||<|0.001|TWO_SIDED|95.0|-7.68|-2.92|||cLDA|||||-2.92|-7.68|<0.001
71856375|NCT02630706|143226376|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-2.64||||0.058|TWO_SIDED|95.0|-5.36|0.09|||cLDA|||||0.09|-5.36|0.058
71856376|NCT02630706|143226376|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.08||||0.003|TWO_SIDED|95.0|-6.78|-1.39|||cLDA|||||-1.39|-6.78|0.003
71856377|NCT02630706|143226377|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.4||||0.086|TWO_SIDED|95.0|-3.0|0.2|||cLDA|||||0.20|-3.00|0.086
71856378|NCT02630706|143226377|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.42||||0.081|TWO_SIDED|95.0|-3.01|0.17|||cLDA|||||0.17|-3.01|0.081
71856379|NCT02630706|143226378|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-0.95||||0.315|TWO_SIDED|95.0|-2.8|0.9|||cLDA|||||0.90|-2.80|0.315
71856380|NCT02630706|143226378|SUPERIORITY|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.0||||0.282|TWO_SIDED|95.0|-2.83|0.83|||cLDA|||||0.83|-2.83|0.282
71856381|NCT02630706|143226379|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.9||||0.001|TWO_SIDED|95.0|2.46|32.22||Nominal p-values were provided.|Logistic regression model|||||32.22|2.46|0.001
71856382|NCT02630706|143226379|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|10.69|||<|0.001|TWO_SIDED|95.0|2.95|38.71||Nominal p-values were provided.|Logistic regression model|||||38.71|2.95|<0.001
71856383|NCT02630706|143226380|SUPERIORITY|Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.34|||<|0.001|TWO_SIDED|95.0|2.52|27.6||Nominal p-values were provided.|Logistic regression model|||||27.60|2.52|<0.001
71856384|NCT02630706|143226380|SUPERIORITY|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.29|||<|0.001|TWO_SIDED|95.0|2.44|28.11||Nominal p-values were provided.|Logistic regression model|||||28.11|2.44|<0.001
71856385|NCT02630706|143226381|OTHER||Difference in % (Ert. 15 mg. - placebo)|-9.0|||<|0.001||95.0|-14.5|-5.0|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-5.0|-14.5|<0.001
71856386|NCT02630706|143226381|OTHER||Difference in % (Ert. 5 mg. - placebo)|-8.4|||<|0.001|TWO_SIDED|95.0|-14.0|-4.4|||Miettinen & Nurminen method|Miettinen \& Nurminen method stratified by country ('China' or 'other') for the overall population.||||-4.4|-14.0|<0.001
71856387|NCT02630706|143226382|OTHER||Difference in % (Ert. 15 mg. - placebo)|-8.9||||0.001||95.0|-15.1|-4.2|||Miettinen & Nurminen method|||||-4.2|-15.1|0.001
71856388|NCT02630706|143226382|OTHER||Difference in % (Ert. 5 mg. - placebo)|-9.6|||<|0.001|TWO_SIDED|95.0|-15.8|-5.7|||Miettinen & Nurminen method|||||-5.7|-15.8|<0.001
71856389|NCT03790878|143226443|OTHER|||||||0.018|||||||ANCOVA|||||||0.018
71856390|NCT03790878|143226444|OTHER|||||||0.396|||||||Multilevel modeling|||||||0.396
71856391|NCT03790878|143226445|OTHER|||||||0.002|||||||Multilevel modeling|||||||0.002
71856392|NCT01180790|143226517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||||||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg, 400 mg, and 800 mg ACH-0141625.|exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of participants achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.||||0.003
71856393|NCT01180790|143226517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
71856394|NCT01180790|143226517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
71856395|NCT01180790|143226517|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Fisher Exact|||To control for multiplicity, the proportion in each treatment group achieving RVR4 is analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||||0.004
71856396|NCT01180790|143226519|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34||||||To control for multiplicity, the proportion of participants in each treatment group achieving cEVR is analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-0141625, 400 mg ACH-0141625, and 800 mg ACH-0141625.|Exact Cochran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of participants in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of participants achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.||||0.34
71856397|NCT01064856|143226547|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Pearson's chi-square|||||||0.006
71856398|NCT01064856|143226549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||<0.001
71856399|NCT01064856|143226550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.003
71856400|NCT01064856|143226551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.||||||0.051
71905667|NCT03260205|143333560|SUPERIORITY||Difference in Least Square Mean|-5.9||||0.0242|TWO_SIDED|95.0|-11.01|-0.78|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.||-0.78|-11.01|0.0242
71905668|NCT03260205|143333561|SUPERIORITY||Difference in Least Mean Square|-0.6||||0.0074|TWO_SIDED|95.0|-1.03|-0.16|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.||-0.16|-1.03|0.0074
71905669|NCT03003403|143333608|SUPERIORITY||Risk Ratio (RR)|1.0||||0.97|TWO_SIDED|95.0|0.82|1.2|||bootstrap resampling|||||1.20|0.82|0.97
71905670|NCT03003403|143333609|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.83|TWO_SIDED|95.0|-1.24|1.0|||Mixed Models Analysis|||||1.00|-1.24|0.83
71905671|NCT03003403|143333610|SUPERIORITY|Difference in systolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-1.2||||0.34|TWO_SIDED|95.0|-3.6|1.3|||Mixed Models Analysis|||||1.3|-3.6|0.34
71905672|NCT03003403|143333610|SUPERIORITY|Difference in diastolic blood pressure change post-baseline comparing intervention to usual care arm at 24 months.|Mean Difference (Final Values)|-0.8||||0.323|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.323
71905673|NCT03003403|143333611|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.991|TWO_SIDED|95.0|-0.8|0.8|||Mixed Models Analysis|||||0.8|-0.8|0.991
71905674|NCT00961662|143333625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode||||<0.05
71905675|NCT03006471|143333665|SUPERIORITY|||||||0.755||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.755
71905676|NCT03006471|143333665|SUPERIORITY|||||||0.046||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.046
71905677|NCT03006471|143333666|SUPERIORITY|||||||0.752||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.752
71905678|NCT03006471|143333666|SUPERIORITY|||||||0.582||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.582
71905679|NCT03006471|143333667|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
71905680|NCT03006471|143333667|SUPERIORITY|||||||0.22||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.220
71905681|NCT03006471|143333668|SUPERIORITY|||||||0.624||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.624
71905682|NCT03006471|143333668|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||1.000
71905683|NCT03006471|143333669|SUPERIORITY|||||||0.906||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.906
71905684|NCT03006471|143333669|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.017
71905685|NCT03006471|143333670|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.454
71905686|NCT03006471|143333670|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.115
71905687|NCT03006471|143333671|SUPERIORITY|||||||0.422||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.422
71905688|NCT03006471|143333671|SUPERIORITY|||||||0.917||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.917
71856401|NCT00113269|143226561|SUPERIORITY_OR_OTHER||differences in event rates|-3.3||||0.4889|TWO_SIDED|95.305|-12.7|6.1|||Normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||6.1|-12.7|0.4889
71856402|NCT00113269|143226561|SUPERIORITY_OR_OTHER||differences in event rates|-15.7|||<|0.0001|TWO_SIDED|95.305|-21.9|-9.4|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.|||-9.4|-21.9|<0.0001
71856403|NCT00113269|143226562|SUPERIORITY_OR_OTHER||differences in event rates|2.7||||0.6533|TWO_SIDED|95.0|-9.0|14.3|||normal approximation|||||14.3|-9.0|0.6533
71856404|NCT00113269|143226562|SUPERIORITY_OR_OTHER||differences in event rates|-11.9||||0.0024|TWO_SIDED|95.0|-19.5|-4.2|||normal approximation|||||-4.2|-19.5|0.0024
71856405|NCT00113269|143226563|SUPERIORITY_OR_OTHER||differences in event rates|-6.1||||0.4087|TWO_SIDED|95.0|-20.7|8.4|||normal approximation|||||8.4|-20.7|0.4087
71856406|NCT00113269|143226563|SUPERIORITY_OR_OTHER||differences in event rates|-8.7||||0.0456|TWO_SIDED|95.0|-17.2|-0.2|||normal approximation|||||-0.2|-17.2|0.0456
71905689|NCT03006471|143333672|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.650
71905690|NCT03006471|143333672|SUPERIORITY|||||||0.108||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.108
71905691|NCT03006471|143333673|SUPERIORITY|||||||0.875||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.875
71856407|NCT00113269|143226564|SUPERIORITY_OR_OTHER||differences in event rates|1.1||||0.8742|TWO_SIDED|95.0|-12.7|15.0|||normal approximation|||||15.0|-12.7|0.8742
71905692|NCT03006471|143333673|SUPERIORITY|||||||0.196||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of waist circumference in dapagliflozin group||||0.196
71856408|NCT00113269|143226564|SUPERIORITY_OR_OTHER||differences in event rates|-14.1||||0.001|TWO_SIDED|95.0|-22.5|-5.7|||normal approximation|||||-5.7|-22.5|0.0010
71856409|NCT00113269|143226566|SUPERIORITY_OR_OTHER||differences in event rates|3.5||||0.4134|TWO_SIDED|95.0|-4.8|11.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||11.7|-4.8|0.4134
71856410|NCT00113269|143226566|SUPERIORITY_OR_OTHER||differences in event rates|2.4||||0.2459|TWO_SIDED|95.0|-1.7|6.5|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.5|-1.7|0.2459
71856411|NCT00113269|143226567|SUPERIORITY_OR_OTHER||differences in event rates|6.0||||0.3155|TWO_SIDED|95.0|-5.7|17.6|||normal approximation|||||17.6|-5.7|0.3155
71856412|NCT00113269|143226567|SUPERIORITY_OR_OTHER||differences in event rates|-0.4||||0.9045|TWO_SIDED|95.0|-6.5|5.7|||normal approximation|||||5.7|-6.5|0.9045
71856413|NCT00113269|143226568|SUPERIORITY_OR_OTHER||differences in event rates|1.6||||0.5265|TWO_SIDED|95.0|-3.4|6.7|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||6.7|-3.4|0.5265
71856414|NCT00113269|143226568|SUPERIORITY_OR_OTHER||differences in event rates|-0.6||||0.682|TWO_SIDED|95.0|-3.4|2.2|||normal approximation|Analysis based on normal approximation using Greenwood's formula for standard error.||||2.2|-3.4|0.6820
71856415|NCT00113269|143226569|SUPERIORITY_OR_OTHER||differences in event rates|5.9||||0.1797|TWO_SIDED|95.0|-2.7|14.4|||normal approximation|||||14.4|-2.7|0.1797
71856416|NCT00113269|143226569|SUPERIORITY_OR_OTHER||differences in event rates|-1.4||||0.5655|TWO_SIDED|95.0|-6.3|3.4|||normal approximation|||||3.4|-6.3|0.5655
71856417|NCT00113269|143226570|SUPERIORITY_OR_OTHER|||||||0.4735||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.4735
71856418|NCT00113269|143226570|SUPERIORITY_OR_OTHER|||||||0.1186||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1186
71856419|NCT00113269|143226571|SUPERIORITY_OR_OTHER|||||||0.5231||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.5231
71856420|NCT00113269|143226571|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'||||0.1220
71905693|NCT03006471|143333674|SUPERIORITY|||||||0.552||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.552
71905694|NCT03006471|143333674|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.087
71856421|NCT03119688|143226607|NON_INFERIORITY|The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.|Mean Difference (Net)|-0.077||||0.1769|TWO_SIDED|90.0|-0.1707|0.0169||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.||0.0169|-0.1707|0.1769
71905695|NCT03006471|143333675|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
71905696|NCT03006471|143333675|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.463
71905697|NCT03006471|143333676|SUPERIORITY|||||||0.53||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.530
71905698|NCT03006471|143333676|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.507
71905699|NCT03006471|143333677|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
71905700|NCT03006471|143333677|SUPERIORITY|||||||0.972||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.972
71905701|NCT03006471|143333678|SUPERIORITY|||||||0.152||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.152
71905702|NCT03006471|143333678|SUPERIORITY|||||||0.158||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.158
71905703|NCT03006471|143333679|SUPERIORITY|||||||0.944||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.944
71905704|NCT03006471|143333679|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.650
71905705|NCT03006471|143333680|SUPERIORITY|||||||0.087||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.087
71905706|NCT03006471|143333680|SUPERIORITY|||||||0.345||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.345
71905707|NCT03006471|143333681|SUPERIORITY|||||||0.115||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention group||||0.115
71905708|NCT03006471|143333682|SUPERIORITY|||||||0.047||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.047
71905709|NCT03006471|143333683|SUPERIORITY|||||||0.539||||||The threshold for statistical significance was p=0.05|Chi-squared|||Results showed in this section are the result of the differences between change of intervention groups||||0.539
71905710|NCT03006471|143333684|SUPERIORITY|||||||0.844||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.844
71905711|NCT03006471|143333684|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.010
71905712|NCT03006471|143333685|SUPERIORITY|||||||0.814||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.814
71905713|NCT03006471|143333685|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
71905714|NCT03006471|143333686|SUPERIORITY|||||||0.221||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.221
71905715|NCT03006471|143333686|SUPERIORITY|||||||0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.001
71905716|NCT03006471|143333687|SUPERIORITY|||||||0.461||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.461
71905717|NCT03006471|143333687|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.011
71905718|NCT03006471|143333688|SUPERIORITY|||||||0.285||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.285
71905719|NCT03006471|143333688|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.002
71905720|NCT03006471|143333689|SUPERIORITY|||||||0.701||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.701
71856422|NCT03119688|143226607|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.35|||<|0.0001|TWO_SIDED|90.0|0.2565|0.4441||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.4441|0.2565|<.0001
71856423|NCT03119688|143226607|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.427|||<|0.0001|TWO_SIDED|90.0|0.3333|0.5211||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.5211|0.3333|<.0001
71905721|NCT03006471|143333689|SUPERIORITY|||||||0.081||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.081
71905722|NCT03006471|143333690|SUPERIORITY|||||||0.581||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.581
71905723|NCT03006471|143333690|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-cholesterol on dapagliflozin group||||0.004
71905724|NCT03006471|143333691|SUPERIORITY|||||||0.727||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.727
71905725|NCT03006471|143333691|SUPERIORITY|||||||0.451||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.451
71905726|NCT03006471|143333692|SUPERIORITY|||||||0.463||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.463
71681109|NCT01541839|142881040|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|327.0|STANDARD_DEVIATION|70.0|<|0.0001|TWO_SIDED|95.0|||||t-test, 1 sided||The mean time for closure with septal stapler was 35 +/-22 seconds versus 7 minutes +/- 1 minute 10 seconds for suture closure. The mean net difference between groups was 327 seconds, or 6 minutes 27 seconds.|The operative time required for closure and NOSE questionnaire scores were analyzed with unpaired and paired t-tests respectively. Chi-squared testing was used for post-operative complication rates. The mean closure time for septoplasty was estimated to be 10 minutes +/- 4 minutes. It was assumed that the septal stapler would take 5 minutes +/- 4 minutes. Assuming a one-sided test, an alpha of 0.05 and a power of 0.8, a total of 16 patients were needed.||||<0.0001
71856424|NCT03119688|143226607|SUPERIORITY|This is a superiority test setting.|Mean Difference (Net)|0.065||||0.2518|TWO_SIDED|90.0|-0.0287|0.1592||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.||0.1592|-0.0287|0.2518
71905727|NCT03006471|143333692|SUPERIORITY|||||||0.043||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.043
71905728|NCT03006471|143333693|SUPERIORITY|||||||0.807||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.807
71905729|NCT03006471|143333693|SUPERIORITY|||||||0.754||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.754
71905730|NCT03006471|143333694|SUPERIORITY|||||||0.507||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in placebo group||||0.507
71905731|NCT03006471|143333694|SUPERIORITY|||||||0.015||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values in dapagliflozin group||||0.015
71905732|NCT03006471|143333695|SUPERIORITY|||||||0.039||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.039
71905733|NCT03006471|143333696|SUPERIORITY|||||||0.011|||||||Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.011
71905734|NCT03006471|143333697|SUPERIORITY|||||||0.096||||||The threshold for statistical significance was p=0.05|Fisher Exact|||Results showed in this section are the result of the differences between intervention groups||||0.096
71905735|NCT03162055|143333736|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-87.2|STANDARD_ERROR_OF_MEAN|13.3||0.9974|TWO_SIDED|97.5|-117.0|-57.4|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-57.4|-117.0|0.9974
71856425|NCT03226106|143226613|SUPERIORITY||Mean Difference (Final Values)|930.51||||0.024|TWO_SIDED|95.0|41.65|1819.36||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1819.36|41.65|0.024
71856426|NCT03226106|143226614|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.584|TWO_SIDED|95.0|-0.67|2.07||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.07|-0.67|0.584
71856427|NCT03226106|143226615|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.724|TWO_SIDED|95.0|-1.4|1.32||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1.32|-1.40|0.724
71681110|NCT00551161|142881098|SUPERIORITY_OR_OTHER||||||<|0.05||||||Due to the exploratory nature of these analyses, no adjustment for multiple testing was made. Although it would have been preferable to carry out an omnibus analysis, due to the small sample size, the descriptive approach described above was used.|Wilcoxon (Mann-Whitney)|||The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 \[(t2 - t1) - (t1 - t0)\] for each of the metabolites and ratios, in order to examine whether the rate of change differed while on monotherapy as compared with combination therapy.||||<0.05
71856428|NCT03226106|143226616|SUPERIORITY||Mean Difference (Final Values)|7.49||||0.547|TWO_SIDED|95.0|-18.9|33.89||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||33.89|-18.90|0.547
71905736|NCT03162055|143333737|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|13.1||0.0002|TWO_SIDED|97.5|-32.8|25.9|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||25.9|-32.8|0.0002
71905737|NCT03162055|143333738|SUPERIORITY||Odds Ratio (OR)|2.3|||<|0.0001|TWO_SIDED|95.0|1.79|2.95|||Regression, Logistic|ln (1/(1-p))=Treatment+baseline FEV1+BR a/s MDI+stratification factor (prior treatment)+region.p=percentage of participants with increase of \>=100 mL.|Estimate of the log odds of being a responder in the GFF treatment group compared to the UV treatment group using a logistic regression.|||2.95|1.79|<0.0001
71905738|NCT03162055|143333739|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-15.2|STANDARD_ERROR_OF_MEAN|19.4||0.0371|TWO_SIDED|95.0|-53.4|22.9|||Repeated measures analysis|Change from baseline = Treatment + baseline IC + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||22.9|-53.4|0.0371
71905739|NCT03162055|143333740|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -1.0 unit.|Least Square Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.59|-0.14|||Repeated measures analysis|TDI focal score = Treatment + Baseline Dyspnea Index + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean TDI focal score over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||-0.14|-0.59|<0.0001
71905740|NCT03162055|143333741|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.023||0.0017|TWO_SIDED|95.0|-0.011|0.078|||Repeated measures analysis|Change from baseline = Treatment + baseline EMSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.078|-0.011|0.0017
71905741|NCT03162055|143333742|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0088|TWO_SIDED|95.0|-0.005|0.09|||Repeated measures analysis|Change from baseline = Treatment + baseline NiSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||0.090|-0.005|0.0088
71905742|NCT03162055|143333743|SUPERIORITY||Least Square Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.2||0.9995|TWO_SIDED|95.0|0.26|1.04|||Repeated measures analysis|Change from baseline =Treatment + baseline rescue a/s MDI use + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.04|0.26|0.9995
71905743|NCT03162055|143333744|NON_INFERIORITY|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 2.0 unit.|Least Square Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|0.07|1.11|||Repeated measures analysis|Change from baseline = Treatment + baseline CAT score + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||1.11|0.07|<0.0001
71856429|NCT03226106|143226617|SUPERIORITY||Mean Difference (Final Values)|4.93||||0.716|TWO_SIDED|95.0|-21.67|31.54||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||31.54|-21.67|0.716
71905744|NCT03162055|143333745|SUPERIORITY||Least Square Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|12.8||0.5516|TWO_SIDED|97.5|-30.3|27.0|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.|||27.0|-30.3|0.5516
71905745|NCT02581865|143333746|SUPERIORITY||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|1.8||0.4326|TWO_SIDED|95.0|-4.9|2.1|||Mixed Models Analysis|||||2.1|-4.9|0.4326
71905746|NCT02581865|143333746|SUPERIORITY||Mean Difference (Net)|-2.5|STANDARD_ERROR_OF_MEAN|1.9||0.1835|TWO_SIDED|95.0|-6.2|1.2|||Mixed Models Analysis|||||1.2|-6.2|0.1835
71905747|NCT02581865|143333747|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3812|TWO_SIDED|95.0|-0.7|0.3|||ANOVA|||||0.3|-0.7|0.3812
71905748|NCT02581865|143333747|SUPERIORITY||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0146|TWO_SIDED|95.0|-1.2|-0.1|||ANOVA|||||-0.1|-1.2|0.0146
71905749|NCT02581865|143333748|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3065|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||||0.2|-0.6|0.3065
71905750|NCT02581865|143333748|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.2052|TWO_SIDED|95.0|-0.7|0.2|||Mixed Models Analysis|||||0.2|-0.7|0.2052
71905751|NCT02581865|143333749|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|0.8||0.2215|TWO_SIDED|95.0|-2.7|0.6|||ANCOVA|||||0.6|-2.7|0.2215
71905752|NCT02581865|143333749|SUPERIORITY||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|0.9||0.0566|TWO_SIDED|95.0|-3.3|0.0|||ANCOVA|||||0.0|-3.3|0.0566
71905753|NCT02581865|143333750|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|3.8||0.5689|TWO_SIDED|95.0|-9.8|5.4|||Mixed Models Analysis|||||5.4|-9.8|0.5689
71905754|NCT02581865|143333750|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.0||0.232|TWO_SIDED|95.0|-12.8|3.1|||Mixed Models Analysis|||||3.1|-12.8|0.2320
71905755|NCT02581865|143333751|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.1||0.4515|TWO_SIDED|95.0|-3.0|1.3|||Mixed Models Analysis|||||1.3|-3.0|0.4515
71905756|NCT02581865|143333751|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.1||0.6289|TWO_SIDED|95.0|-2.8|1.7|||Mixed Models Analysis|||||1.7|-2.8|0.6289
71905757|NCT01617655|143333758|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-51.1|-27.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-27.1|-51.1|<0.0001
71905758|NCT01617655|143333759|SUPERIORITY_OR_OTHER||LS mean difference|-38.9|||<|0.0001|TWO_SIDED|95.0|-51.0|-26.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.9|-51|<0.0001
71905759|NCT01617655|143333760|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.3|-51.4|<0.0001
71905760|NCT01617655|143333761|SUPERIORITY_OR_OTHER||LS mean difference|-40.3|||<|0.0001|TWO_SIDED|95.0|-51.4|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-29.2|-51.4|<0.0001
71905761|NCT01617655|143333762|SUPERIORITY_OR_OTHER||LS mean difference|-30.3|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.9|-39.7|<0.0001
71905762|NCT01617655|143333763|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.7|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-20.7|-39.7|<0.0001
71905763|NCT01617655|143333764|SUPERIORITY_OR_OTHER||LS mean difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-46.3|-25.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.3|-46.3|<0.0001
71905764|NCT01617655|143333765|SUPERIORITY_OR_OTHER||LS mean difference|-35.5|||<|0.0001|TWO_SIDED|95.0|-46.2|-24.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.9|-46.2|<0.0001
71905765|NCT01617655|143333766|SUPERIORITY_OR_OTHER||LS mean difference|-28.4|||<|0.0001|TWO_SIDED|95.0|-37.3|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-37.3|<0.0001
71905766|NCT01617655|143333767|SUPERIORITY_OR_OTHER||LS mean difference|-30.2|||<|0.0001|TWO_SIDED|95.0|-39.2|-21.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.1|-39.2|<0.0001
71905767|NCT01617655|143333768|SUPERIORITY_OR_OTHER||LS mean difference|-34.5|||<|0.0001|TWO_SIDED|95.0|-44.8|-24.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.1|-44.8|<0.0001
71905768|NCT01617655|143333769|SUPERIORITY_OR_OTHER||LS mean difference|-27.8|||<|0.0001|TWO_SIDED|95.0|-36.2|-19.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.4|-36.2|<0.0001
71681111|NCT00772005|142881124|SUPERIORITY_OR_OTHER|||||||0.8514||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8514
71681112|NCT00772005|142881124|SUPERIORITY_OR_OTHER|||||||0.6995||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6995
71856430|NCT03226106|143226618|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.946|TWO_SIDED|95.0|-0.88|0.82||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.82|-0.88|0.946
71856431|NCT03226106|143226619|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.906|TWO_SIDED|95.0|-1.08|0.52||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||0.52|-1.08|0.906
71856432|NCT03226106|143226620|SUPERIORITY||Mean Difference (Final Values)|-1.55||||0.873|TWO_SIDED|95.0|-7.59|4.49||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.49|-7.59|0.873
71856433|NCT03226106|143226621|SUPERIORITY||Mean Difference (Final Values)|-6.26||||0.241|TWO_SIDED|95.0|-12.48|-0.04||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||-0.04|-12.48|0.241
71856434|NCT03226106|143226622|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.223|TWO_SIDED|95.0|-0.39|6.12||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||6.12|-0.39|0.223
71856435|NCT03226106|143226623|SUPERIORITY||Mean Difference (Final Values)|1.17||||0.388|TWO_SIDED|95.0|-2.19|4.53||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.53|-2.19|0.388
71856436|NCT03226106|143226624|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.88|TWO_SIDED|95.0|-4.08|2.68||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||2.68|-4.08|0.88
71856437|NCT03226106|143226625|SUPERIORITY||Mean Difference (Final Values)|0.77||||0.85|TWO_SIDED|95.0|-2.63|4.17||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||4.17|-2.63|0.85
71905769|NCT01617655|143333770|SUPERIORITY_OR_OTHER||LS mean difference|-39.1|||<|0.0001|TWO_SIDED|95.0|-53.6|-24.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-24.6|-53.6|<0.0001
71905770|NCT01617655|143333771|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.7||||0.0016|TWO_SIDED|95.0|2.5|53.5||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||53.5|2.5|0.0016
71905771|NCT01617655|143333772|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.9||||0.0014|TWO_SIDED|95.0|2.6|54.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||54.9|2.6|0.0014
71905772|NCT01617655|143333773|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.8||||0.0164|TWO_SIDED|95.0|-26.9|-2.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-2.7|-26.9|0.0164
71905773|NCT01617655|143333774|SUPERIORITY_OR_OTHER||LS mean difference|3.7||||0.2745|TWO_SIDED|95.0|-2.9|10.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.2|-2.9|0.2745
71905774|NCT03224585|143333786|SUPERIORITY|||||||0.0121|||||||Paired samples Wilcoxon test|||This analysis compared the change in pain scores between baseline and 6 hours||||0.0121
71905775|NCT03224585|143333787|SUPERIORITY|||||||0.0025|||||||Paired samples Wilcoxon test|||||||0.0025
71905776|NCT01175213|143333788|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.02|||<|0.0001|ONE_SIDED|99.0||0.045||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||||0.045||<0.0001
71905777|NCT01921634|143333812|SUPERIORITY||Odds Ratio (OR)|1.3||||0.01|TWO_SIDED|95.0|1.1|1.7|||McNemar||The odds ratio was generated from a logistic regression model using generalized estimating equations with a logit link and represents a comparison of modified (numerator) vs standard (denominator).|||1.7|1.1|0.01
71681113|NCT00772005|142881124|SUPERIORITY_OR_OTHER|||||||0.9766||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9766
71856438|NCT03226106|143226626|SUPERIORITY||Mean Difference (Final Values)|559.81||||0.101|TWO_SIDED|95.0|-405.01|1524.62||The value corresponds to the interaction between time and group assignment.|Mixed Models Analysis|We used a linear mixed model with a random intercept for subject and fixed effects for age, time, and interaction between intervention arm and time.|The difference is the estimated mean between the intervention and control arms.|||1524.62|-405.01|0.101
71856439|NCT00637247|143226659|SUPERIORITY_OR_OTHER|||||||0.2|||||||Log Rank|||The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.||||0.2
71856440|NCT01772823|143226701|OTHER|||||||0.7513||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Size of the Pill) differ between intervention arms."|Chi-squared|||||||0.7513
71856441|NCT01772823|143226702|OTHER|||||||0.8281||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Taste of the Pill) differ between intervention arms."|Chi-squared|Pearson Chi-Square||||||0.8281
71856442|NCT01772823|143226703|OTHER|||||||0.3761||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Color of the Pill) differ between intervention arms."|Chi-squared|||||||0.3761
71905778|NCT00781963|143333856|SUPERIORITY||Mean Difference (Final Values)|-15.8|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-28.7|-3.0|||Mixed Models Analysis||The parameter estimate is the improvement in sleep onset latency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-3.0|-28.7|<.001
71905779|NCT00781963|143333857|SUPERIORITY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|8.2||0.21|TWO_SIDED|95.0|-26.3|5.9|||Mixed Models Analysis||The parameter estimate is the improvement in wake after sleep onset from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||5.9|-26.3|0.21
71905780|NCT00781963|143333858|SUPERIORITY||Mean Difference (Final Values)|-37.0|STANDARD_ERROR_OF_MEAN|12.9||0.004|TWO_SIDED|95.0|-62.2|-11.7|||Mixed Models Analysis||The parameter estimate is the improvement in total wake time from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-11.7|-62.2|0.004
71681114|NCT00772005|142881125|SUPERIORITY_OR_OTHER|||||||0.7596||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7596
71856443|NCT01772823|143226704|OTHER|||||||0.4359||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking the pill every day) differ between intervention arms."|Chi-squared|||||||0.4359
71856444|NCT01772823|143226705|OTHER|||||||0.3801||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking part in the study) differ between intervention arms."|Chi-squared|||||||0.3801
71856445|NCT01772823|143226706|OTHER|||||||0.1968||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on HIV test at every visit) differ between intervention arms."|Chi-squared|||||||0.1968
71856446|NCT01772823|143226707|OTHER|||||||0.1226||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Risk Reduction counseling at every visit) differ between intervention arms."|Chi-squared|||||||0.1226
71856447|NCT01772823|143226708|OTHER|||||||0.0994||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Questions about sexual behavior) differ between intervention arms."|Chi-squared|||||||0.0994
71856448|NCT01772823|143226709|OTHER|||||||0.5285||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Physician exam) differ between intervention arms."|Chi-squared|||||||0.5285
71856449|NCT01772823|143226713|OTHER|||||||0.0001||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0001
71856450|NCT01772823|143226714|OTHER|||||||0.0098||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0098
71856451|NCT01772823|143226715|OTHER|||||||0.0766||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0766
71856452|NCT01772823|143226716|OTHER|||||||0.1581||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1581
71856453|NCT01772823|143226717|OTHER|||||||0.43||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.4300
71856454|NCT01772823|143226718|OTHER|||||||0.1201||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1201
71905781|NCT00781963|143333859|SUPERIORITY||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|2.36||0.005|TWO_SIDED|95.0|2.0|11.3|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||11.3|2.0|.005
71905782|NCT00781963|143333860|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15|TWO_SIDED|95.0|-3.3|0.5|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency (from wrist actigraphy) from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||0.5|-3.3|0.15
71856455|NCT01772823|143226719|OTHER|||||||0.1682||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.1682
71905783|NCT00781963|143333861|SUPERIORITY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis||The parameter estimate is the improvement in PSQI score from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.|||-1.3|-3.5|<.001
71905784|NCT00680953|143333862|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.343||||0.0001|TWO_SIDED|95.0|0.194|0.606|||Log Rank|||||0.606|0.194|0.0001
71905785|NCT00680953|143333863|SUPERIORITY_OR_OTHER|||||||0.9951|||||||Log Rank|||||||0.9951
71905786|NCT00680953|143333864|SUPERIORITY_OR_OTHER|||||||0.1568|||||||Log Rank|||||||0.1568
71905787|NCT02064205|143333865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.0|STANDARD_DEVIATION|1000.0||0.2918|ONE_SIDED||||||Mixed Models Analysis|||A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)||||0.2918
71681115|NCT00772005|142881125|SUPERIORITY_OR_OTHER|||||||0.562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5620
71856456|NCT01772823|143226720|OTHER|||||||0.2747||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.2747
71856457|NCT01772823|143226721|OTHER|||||||0.0046||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0046
71856458|NCT01772823|143226722|OTHER|||||||0.029||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared|||||||0.0290
71856459|NCT01772823|143226723|OTHER|||||||0.107|||||||Kruskal-Wallis|||||||0.1070
71856460|NCT01772823|143226725|OTHER|||||||0.2991||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.2991
71856461|NCT01772823|143226726|OTHER|||||||0.0298||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.0298
71856462|NCT01772823|143226727|OTHER|||||||0.8643||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.8643
71856463|NCT01772823|143226728|OTHER|||||||0.9037||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.9037
71856464|NCT01772823|143226729|OTHER|||||||0.5279|||||||Kruskal-Wallis|||||||0.5279
71856465|NCT01772823|143226730|OTHER|||||||0.5369||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact|||||||0.5369
71905788|NCT02064205|143333866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Mixed Models Analysis|||AUC of hunger scores before preload intake for condition C versus D.||||0.0109
71905789|NCT02064205|143333867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0216||||||GLP-1|Mixed Models Analysis|||A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.||||0.0216
71905790|NCT03057951|143333868|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.79||||0.0003|TWO_SIDED|95.03|0.69|0.9|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Cox regression, with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) at baseline.~alpha=0.0497 (resulting from interim analysis)."||0.90|0.69|0.0003
71905791|NCT03057951|143333869|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.73||||0.0009|TWO_SIDED|95.03|0.61|0.88|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, baseline LVEF, region, baseline diabetes status, sex, and treatment. eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction. alpha=0.0497 (resulting from interim analysis).||0.88|0.61|0.0009
71856466|NCT01772823|143226733|OTHER|||||||0.2193||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2193
71856467|NCT01772823|143226734|OTHER|||||||0.1255||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1255
71856468|NCT01772823|143226735|OTHER|||||||0.0706||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0706
71856469|NCT01772823|143226736|OTHER|||||||0.0088||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0088
71856470|NCT01772823|143226737|OTHER|||||||0.2482||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2482
71856471|NCT01772823|143226738|OTHER|||||||0.1647||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1647
71856472|NCT01772823|143226739|OTHER|||||||0.688||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.6880
71856473|NCT01772823|143226740|OTHER|||||||0.2881||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2881
71856474|NCT01772823|143226741|OTHER|||||||0.2223||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.2223
71856475|NCT01772823|143226742|OTHER|||||||0.0617||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0617
71856476|NCT01772823|143226743|OTHER|||||||0.0868||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0868
71856477|NCT01772823|143226744|OTHER|||||||0.1847||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.1847
71856478|NCT01772823|143226745|OTHER|||||||0.0226||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared|||||||0.0226
71856479|NCT03712449|143226747|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0009|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0009
71681116|NCT00772005|142881125|SUPERIORITY_OR_OTHER|||||||0.6688||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6688
71681117|NCT00772005|142881126|SUPERIORITY_OR_OTHER|||||||0.1894||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1894
71856480|NCT03712449|143226747|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71856481|NCT03712449|143226748|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.7878|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.7878
71856482|NCT03712449|143226748|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0349|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0349
71856483|NCT03712449|143226749|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0043|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0043
71856484|NCT03712449|143226749|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71856485|NCT03712449|143226750|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0017|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0017
71856486|NCT03712449|143226750|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71856487|NCT03712449|143226751|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0105|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0105
71856488|NCT03712449|143226751|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71856489|NCT03712449|143226752|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0004|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0004
71856490|NCT03712449|143226752|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<.0001
71856491|NCT03712449|143226757|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.||||||0.0005|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||0.0005
71856492|NCT03712449|143226757|OTHER|The data was analyzed using Paired t-test. If normality was not met, then the Wilcoxon signed-rank test was used.|||||<|0.0001|||||||Paired t-test/Wilcoxon Signed Rank Test|||||||<0.0001
71856493|NCT00451555|143226781|SUPERIORITY|||||||0.6238|||||||Fisher Exact|||||||0.6238
71856494|NCT00451555|143226781|SUPERIORITY|||||||0.6282|||||||Fisher Exact|||||||0.6282
71856495|NCT00451555|143226781|SUPERIORITY|||||||0.6242|||||||Fisher Exact|||||||0.6242
71856496|NCT00451555|143226782|SUPERIORITY|||||||0.639|||||||Fisher Exact|||||||0.6390
71681118|NCT00772005|142881126|SUPERIORITY_OR_OTHER|||||||0.4582||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4582
71856497|NCT00451555|143226782|SUPERIORITY|||||||0.6721|||||||Fisher Exact|||||||0.6721
71856498|NCT00451555|143226782|SUPERIORITY|||||||0.6349|||||||Fisher Exact|||||||0.6349
71856499|NCT00451555|143226783|SUPERIORITY|||||||0.8582|||||||Log Rank|||||||0.8582
71856500|NCT00451555|143226783|SUPERIORITY|||||||0.7307|||||||Log Rank|||||||0.7307
71856501|NCT00451555|143226783|SUPERIORITY|||||||0.9798|||||||Log Rank|||||||0.9798
71856502|NCT00451555|143226784|SUPERIORITY|||||||0.5887|||||||Log Rank|||||||0.5887
71856503|NCT00451555|143226784|SUPERIORITY|||||||0.4516|||||||Log Rank|||||||0.4516
71856504|NCT00451555|143226784|SUPERIORITY|||||||0.7965|||||||Log Rank|||||||0.7965
71856505|NCT02847637|143226787|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.02|0.075||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.075|0.020|<0.0001
71856506|NCT02847637|143226787|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.017|0.066||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.066|0.017|<0.0001
71856507|NCT02847637|143226788|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.028|0.099||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.099|0.028|<0.0001
71856508|NCT02847637|143226788|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.03|0.103||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.103|0.030|<0.0001
71856509|NCT02847637|143226789|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.019|0.085||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.085|0.019|<0.0001
71856510|NCT02847637|143226789|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.015|0.07||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.070|0.015|<0.0001
71856511|NCT02847637|143226790|SUPERIORITY||ABR Ratio|0.06|||<|0.0001|TWO_SIDED|95.0|0.025|0.151||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.151|0.025|<0.0001
71856512|NCT02847637|143226790|SUPERIORITY||ABR Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.006|0.056||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.056|0.006|<0.0001
71856513|NCT02847637|143226791|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.016|0.143||Not controlled for type I error|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.||0.143|0.016|<0.0001
71681119|NCT00772005|142881126|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
71856514|NCT02847637|143226791|SUPERIORITY||ABR Ratio|0.05|||<|0.0001|TWO_SIDED|95.0|0.018|0.147||Not controlled for type I error|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.||0.147|0.018|<0.0001
71905792|NCT03057951|143333870|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.363|||<|0.0001|TWO_SIDED|99.9|0.861|1.865|||Random intercept random coeff. model||Empa 10 mg vs. Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with factors age, baseline eGFR (CKD-EPI), baseline LVEF as linear covariate(s) and region, baseline diabetes status, sex, baseline-by-time interaction, treatment-by-time interaction and treatment as fixed effects.~Only 'on-treatment' data from treated patients were used. alpha=0.001. covariance structure: Unstructured."||1.865|0.861|<0.0001
71856515|NCT02847637|143226792|SUPERIORITY||ABR Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.195|0.514||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.514|0.195|<0.0001
71856516|NCT02847637|143226793|SUPERIORITY||ABR Ratio|0.37||||0.0002|TWO_SIDED|95.0|0.22|0.626||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.626|0.220|0.0002
71856517|NCT02847637|143226794|SUPERIORITY||ABR Ratio|0.03|||<|0.0001|TWO_SIDED|95.0|0.014|0.067||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.067|0.014|<0.0001
71856518|NCT02847637|143226795|SUPERIORITY||ABR Ratio|0.04|||<|0.0001|TWO_SIDED|95.0|0.023|0.068||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.||0.068|0.023|<0.0001
71856519|NCT02847637|143226796|SUPERIORITY||Mean Difference (Final Values)|12.51||||0.0891|TWO_SIDED|95.0|-1.96|26.98||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||26.98|-1.96|0.0891
71856520|NCT02847637|143226796|SUPERIORITY||Mean Difference (Final Values)|15.97||||0.0349|TWO_SIDED|95.0|1.16|30.78||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||30.78|1.16|0.0349
71856521|NCT02847637|143226797|SUPERIORITY||Mean Difference (Final Values)|5.91||||0.1269|TWO_SIDED|95.0|-1.72|13.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||13.55|-1.72|0.1269
71856522|NCT02847637|143226797|SUPERIORITY||Mean Difference (Final Values)|8.56||||0.0317|TWO_SIDED|95.0|0.77|16.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||16.35|0.77|0.0317
71856523|NCT02847637|143226798|SUPERIORITY||Mean Difference (Final Values)|-4.04||||0.3402|TWO_SIDED|95.0|-12.43|4.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||4.35|-12.43|0.3402
71856524|NCT02847637|143226798|SUPERIORITY||Mean Difference (Final Values)|-9.15||||0.0373|TWO_SIDED|95.0|-17.74|-0.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.55|-17.74|0.0373
71856525|NCT02847637|143226799|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.006|TWO_SIDED|95.0|-0.22|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.|||-0.04|-0.22|0.0060
71856526|NCT02847637|143226799|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.0059|TWO_SIDED|95.0|-0.23|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.|||-0.04|-0.23|0.0059
71856527|NCT01187407|143226851|SUPERIORITY_OR_OTHER|||||||0.997||||||Primary comparison.|Mixed Models Analysis|||||||0.997
71856528|NCT01187407|143226851|SUPERIORITY_OR_OTHER|||||||0.769||||||Secondary comparison.|Mixed Models Analysis|||||||0.769
71856529|NCT00776984|143226878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.091|0.217||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.091|<0.0001
71856530|NCT00776984|143226879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.03||0.0002||95.0|0.053|0.169||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.169|0.053|0.0002
71856531|NCT00776984|143226880|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||||0.0343
71856532|NCT00776984|143226881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0275||95.0|0.01|0.177||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.177|0.010|0.0275
71856533|NCT00776984|143226882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.041||0.0099||95.0|0.025|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.186|0.025|0.0099
71856534|NCT00776984|143226883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.084|0.202||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.202|0.084|<0.0001
71856535|NCT00776984|143226884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.04||0.0063||95.0|0.031|0.187||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.187|0.031|0.0063
71856536|NCT00776984|143226885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.087|0.217||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.217|0.087|<0.0001
71856537|NCT00776984|143226886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.03||0.0026||95.0|0.032|0.151||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.151|0.032|0.0026
71856538|NCT00776984|143226887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.078|0.199||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.078|<0.0001
71856539|NCT00776984|143226888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.044||0.0088||95.0|0.029|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.029|0.0088
71856540|NCT00776984|143226889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.042||0.0933||95.0|-0.012|0.153||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.153|-0.012|0.0933
71856541|NCT00776984|143226890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.041||0.0074||95.0|0.029|0.189||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.189|0.029|0.0074
71856542|NCT00776984|143226891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.654|STANDARD_ERROR_OF_MEAN|4.807|<|0.0001||95.0|11.199|30.108||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||30.108|11.199|<0.0001
71856543|NCT00776984|143226892|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.453|STANDARD_ERROR_OF_MEAN|5.044|<|0.0001||95.0|22.532|42.374||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||42.374|22.532|<0.0001
71905793|NCT03057951|143333871|OTHER||Hazard Ratio (HR)|0.95||||0.7243|TWO_SIDED|95.0|0.73|1.24|||Regression, Cox||Comparison vs Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.24|0.73|0.7243
71681120|NCT00772005|142881127|SUPERIORITY_OR_OTHER|||||||0.3275||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3275
71856544|NCT00776984|143226893|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.03||0.0027||95.0|0.031|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.149|0.031|0.0027
71856545|NCT00776984|143226894|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.074|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.200|0.074|<0.0001
71856546|NCT00776984|143226895|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.197|STANDARD_ERROR_OF_MEAN|0.741||0.1073||95.0|-0.261|2.655||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||2.655|-0.261|0.1073
71856547|NCT00776984|143226896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4788||95.0|0.65|1.23||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||1.23|0.65|0.4788
71856548|NCT00776984|143226897|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|STANDARD_ERROR_OF_MEAN|0.11||0.1007||95.0|0.61|1.04||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.04|0.61|0.1007
71856549|NCT00776984|143226898|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|STANDARD_ERROR_OF_MEAN|0.15||0.7906||95.0|0.71|1.3||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo|||1.30|0.71|0.7906
71856550|NCT00776984|143226899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.57||||0.004||95.0|0.38|0.84||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||0.84|0.38|0.0040
71856551|NCT00776984|143226900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5481||95.0|0.58|1.32||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||1.32|0.58|0.5481
71856552|NCT00776984|143226901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.7188||95.0|0.33|2.14||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|||2.14|0.33|0.7188
71856553|NCT00776984|143226902|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.95|STANDARD_ERROR_OF_MEAN|0.23||0.8503||95.0|0.59|1.54||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo.|||1.54|0.59|0.8503
71856554|NCT00776984|143226903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.8129||95.0|0.29|2.46||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo|||2.46|0.29|0.8129
71856555|NCT00776984|143226904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.078||0.0225||95.0|0.025|0.331||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.331|0.025|0.0225
71905794|NCT03057951|143333872|OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.6|0.83|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||0.83|0.60|<0.0001
71856556|NCT00776984|143226905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.08||0.0803||95.0|-0.017|0.296||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.296|-0.017|0.0803
71856557|NCT00776984|143226906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.199|STANDARD_ERROR_OF_MEAN|0.067||0.003||95.0|-0.33|-0.068||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||-0.068|-0.330|0.0030
71856558|NCT00776984|143226907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.069||0.0533||95.0|-0.267|0.002||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.002|-0.267|0.0533
71856559|NCT00776984|143226908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.028||0.6632||95.0|-0.043|0.067||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.067|-0.043|0.6632
71856560|NCT00776984|143226909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.263|STANDARD_ERROR_OF_MEAN|0.189||0.1664||95.0|-0.635|0.11||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.110|-0.635|0.1664
71856561|NCT00776984|143226910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0427|TWO_SIDED|95.0|1.01|1.73||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks||1.73|1.01|0.0427
71856562|NCT00776984|143226910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0001|TWO_SIDED|95.0|1.28|2.21||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks||2.21|1.28|0.0001
71856563|NCT02573883|143226916|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71856564|NCT02573883|143226917|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71856565|NCT02573883|143226919|SUPERIORITY|||||||0.011|||||||Chi-squared|||||||0.011
71856566|NCT02573883|143226921|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71856567|NCT02725008|143226968|SUPERIORITY||Odds Ratio (OR)|2.32||||0.3|TWO_SIDED|95.0|0.54|10.07|||Chi-squared|||||10.07|0.54|0.3
71856568|NCT02725008|143226969|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71856569|NCT00513461|143226972|SUPERIORITY||Mean Difference (Net)|7.78||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.160
71856570|NCT00513461|143226985|SUPERIORITY||Mean Difference (Net)|0.43||||0.878|TWO_SIDED||||||Two-Group t-test|||||||0.878
71856571|NCT00513461|143226986|SUPERIORITY||Mean Difference (Net)|-3.66||||0.212|TWO_SIDED||||||Two-Group t-test|||||||0.212
71856572|NCT00562484|143226995|SUPERIORITY_OR_OTHER||Vaccine Efficacy|42.0|||||TWO_SIDED|95.0|30.0|52.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||52|30|
71856573|NCT00562484|143226996|SUPERIORITY_OR_OTHER||Vaccine efficacy|60.0|||||TWO_SIDED|95.0|44.0|72.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)||72|44|
71856574|NCT02811302|143227008|OTHER|A simple count and percentage of the population were calculated based on the number of patients adjudicated as having Respiratory Depression.|||||||||||||||||To determine the risk assessment score, first the number of patients with Respiratory Depression (RD) had to be identified. Per the rules established for the Clinical Endpoint Committee, 655 (43.6%) patients were identified as having RD.|||
71882326|NCT02411539|143283554|SUPERIORITY|Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution||||||0.16||||||Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.||||0.16
71882327|NCT04474795|143283592|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Compared pre and post training scores||||<0.0001
71921945|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-17.5|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||0.5|-17.5|
71905795|NCT03057951|143333873|OTHER||Hazard Ratio (HR)|0.91||||0.2951|TWO_SIDED|95.0|0.76|1.09|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.09|0.76|0.2951
71905796|NCT03057951|143333874|OTHER||Hazard Ratio (HR)|1.0||||0.9893|TWO_SIDED|95.0|0.87|1.15|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.15|0.87|0.9893
71905797|NCT03057951|143333875|OTHER||Hazard Ratio (HR)|0.84||||0.1539|TWO_SIDED|95.0|0.65|1.07|||Regression, Cox||Comparison vs. Placebo \[T/P\]|Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.||1.07|0.65|0.1539
71905798|NCT03057951|143333876|OTHER||Adjusted mean difference|1.32|STANDARD_ERROR_OF_MEAN|0.44||0.0028|TWO_SIDED|95.0|0.45|2.19|||Mixed Model Repeated Measures (MMRM)||Comparison vs Placebo \[T-P\]|"Model includes age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF) as linear covariate(s) and region, baseline diabetes status, sex, week reachable, treatment-by-visit interaction, baseline KCCQ-Clinical-Summary-Score-by-visit interaction as fixed effect(s).~Unstructured covariance structure."||2.19|0.45|0.0028
71905799|NCT03057951|143333877|OTHER||Hazard Ratio (HR)|0.93||||0.1012|TWO_SIDED|95.0|0.85|1.01|||Joint frailty model||Comparison vs. Placebo \[T/P\]|Joint frailty model that accounts for the dependence between recurrent all-cause hospitalisation and all-cause mortality was used. Joint frailty model with terms for age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF), treatment, region, baseline diabetes status and sex.||1.01|0.85|0.1012
71905800|NCT00696436|143333878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.27|||<|0.001|TWO_SIDED|95.0|-16.54|-12.01||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-12.01|-16.54|<0.001
71905801|NCT00696436|143333878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.16|||<|0.001|TWO_SIDED|95.0|-15.41|-10.91||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-10.91|-15.41|<0.001
71905802|NCT00696436|143333878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.54||||0.009|TWO_SIDED|95.0|-4.44|-0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.64|-4.44|0.009
71905803|NCT00696436|143333878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.31|||<|0.001|TWO_SIDED|95.0|-6.25|-2.37||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.37|-6.25|<0.001
71905804|NCT00696436|143333878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.43||||0.136|TWO_SIDED|95.0|-3.31|0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||0.45|-3.31|0.136
71905805|NCT00696436|143333878|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2||||0.001|TWO_SIDED|95.0|-5.12|-1.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-1.27|-5.12|0.001
71905806|NCT00696436|143333879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-18.07|-11.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.76|-18.07|<0.001
71905807|NCT00696436|143333879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.55|||<|0.001|TWO_SIDED|95.0|-17.71|-11.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-11.40|-17.71|<0.001
71905808|NCT00696436|143333879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.54||||0.008|TWO_SIDED|95.0|-6.17|-0.92||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.92|-6.17|0.008
71905809|NCT00696436|143333879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.43|||<|0.001|TWO_SIDED|95.0|-8.09|-2.78||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.78|-8.09|<0.001
71905810|NCT00696436|143333879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18||||0.018|TWO_SIDED|95.0|-5.81|-0.55||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-0.55|-5.81|0.018
71905811|NCT00696436|143333879|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||<|0.001|TWO_SIDED|95.0|-7.73|-2.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA|||||-2.42|-7.73|<0.001
71856575|NCT02811302|143227009|OTHER|Multivariable model for (Multivariate logistic regression) Respiratory Depression, followed by validation with Harrell's Optimism using a bootstrap sampling method.|Area Under the Curve|0.76|||||TWO_SIDED|95.0|0.73|0.79|||||The model was performed using stepwise selection including all potential predictors and interactions terms (medical history and baseline characteristics).|A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.|The model derived from the logistic regression was assessed by the Hosmer-Lemshow goodness of fit test (P = 0.831). The derived model was validated by Harrell's Optimism using a Bootstrap sampling method (500 samples from the modified dataset, 1335) with replacement. The logistic regression model with stepwise selection was performed for each bootstrap sample, and AUC calculated. The optimism calculated by Harrell's algorithm was 0.02. The model was then checked for the quartiles of the effective monitoring and for geography used as a random effect. The performance measurement of the final model was adjusted according the Harrell's Optimism for a final adjusted AUC of 0.74.|0.79|0.73|
71856576|NCT00942188|143227018|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.854|||||TWO_SIDED|95.0|-1.94|0.23|||ANCOVA|||||0.23|-1.94|
71856577|NCT00942188|143227018|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.252|||||TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-0.03|-2.48|
71856578|NCT00942188|143227018|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|||||TWO_SIDED|95.0|-1.76|0.54|||ANCOVA|||||0.54|-1.76|
71856579|NCT00942188|143227019|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.995|||||TWO_SIDED|95.0|-9.82|3.83|||ANCOVA|||||3.83|-9.82|
71856580|NCT00942188|143227019|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.324|||||TWO_SIDED|95.0|-10.21|5.56|||ANCOVA|||||5.56|-10.21|
71856581|NCT00942188|143227019|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.635|||||TWO_SIDED|95.0|-9.16|5.89|||ANCOVA|||||5.89|-9.16|
71856582|NCT00942188|143227021|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.59|0.05||This is the estimated value for week 10 HbA1c.|ANCOVA|||||0.05|-0.59|
71856583|NCT00942188|143227021|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.369|||||TWO_SIDED|95.0|-0.74|0.0||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.00|-0.74|
71856584|NCT00942188|143227021|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.227|||||TWO_SIDED|95.0|-0.59|0.13||This is the estimated value for HbA1c at Week 10.|ANCOVA|||||0.13|-0.59|
71856585|NCT00942188|143227021|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.267|||||TWO_SIDED|95.0|-0.61|0.08||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.08|-0.61|
71856586|NCT00942188|143227021|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.396|||||TWO_SIDED|95.0|-0.79|0.0||This is the estimated value for HbA1c at Week 12.|ANCOVA|||||0.00|-0.79|
71856587|NCT00942188|143227021|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.221|||||TWO_SIDED|95.0|-0.59|0.15||This is the estimated value for HbA1c at week 12.|ANCOVA|||||0.15|-0.59|
71856588|NCT00276016|143227025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.561||95.0|||||ANOVA|||For endpoint||||0.561
71856589|NCT00276016|143227026|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANOVA|||For endpoint||||<.001
71856590|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||12.9|-30.8|
71856591|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
71856592|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||12.9|-30.8|
71856593|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events||25.5|-16.4|
71856594|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||1.3|-41.7|
71856595|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events||18.7|-23.3|
71856596|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||8.3|-35.2|
71856597|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events||32.2|-9.5|
71856598|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||12.9|-30.8|
71856599|NCT01568112|143227097|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events||25.5|-16.4|
71856600|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||8.3|-35.2|
71856601|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|12.0|||||TWO_SIDED|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||32.2|-9.5|
71856602|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-39.6|3.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||3.7|-39.6|
71856603|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||27.8|-14.1|
71856604|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||1.3|-41.7|
71681121|NCT00772005|142881127|SUPERIORITY_OR_OTHER|||||||0.2597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2597
71681122|NCT00772005|142881127|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0039
71856605|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||27.8|-14.1|
71856606|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|-33.0|||||TWO_SIDED|95.0|-52.2|-10.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-10.6|-52.2|
71856607|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-21.0|21.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||21.0|-21.0|
71681123|NCT00772005|142881128|SUPERIORITY_OR_OTHER|||||||0.0713||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0713
71856608|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|-21.0|||||TWO_SIDED|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||1.3|-41.7|
71856609|NCT01568112|143227098|SUPERIORITY_OR_OTHER||Difference in percentage|18.0|||||TWO_SIDED|95.0|-2.4|38.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||38.8|-2.4|
71856610|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.2|-35.6|
71856611|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||21.7|-24.7|
71856612|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-14.0|||||TWO_SIDED|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||9.2|-35.6|
71856613|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.9|23.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||23.7|-22.9|
71856614|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-33.0|11.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||11.9|-33.0|
71856615|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-5.0|||||TWO_SIDED|95.0|-27.5|18.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||18.8|-27.5|
71856616|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-17.0|||||TWO_SIDED|95.0|-38.1|6.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||6.5|-38.1|
71905812|NCT00696436|143333880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.36|||<|0.001|TWO_SIDED|95.0|-10.91|-7.81||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.81|-10.91|<0.001
71905813|NCT00696436|143333880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.58|||<|0.001|TWO_SIDED|95.0|-10.12|-7.04||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.04|-10.12|<0.001
71856617|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-11.0|||||TWO_SIDED|95.0|-34.2|12.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||12.2|-34.2|
71856618|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||3.8|-40.6|
71856619|NCT01568112|143227099|SUPERIORITY_OR_OTHER||Difference in percentage|-18.0|||||TWO_SIDED|95.0|-40.2|5.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||5.5|-40.2|
71856620|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-3.0|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||-0.9|-3.0|
71856621|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|0.2|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||2.3|0.2|
71856622|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-3.2|-1.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||-1.2|-3.2|
71856623|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|0.1|2.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||2.5|0.1|
71856624|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|95.0|-2.8|-0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||-0.7|-2.8|
71856625|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|0.1|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||2.3|0.1|
71856626|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|95.0|-2.7|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.9|-2.7|
71681124|NCT00772005|142881128|SUPERIORITY_OR_OTHER|||||||0.0431||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0431
71856627|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-0.4|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||1.6|-0.4|
71856628|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|-1.9|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-2.8|-1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-1.0|-2.8|
71856629|NCT01568112|143227100|SUPERIORITY_OR_OTHER||Mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|0.2|2.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||2.2|0.2|
71856630|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|95.0|-1.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.8|-1.7|
71856631|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.8|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||0.4|-1.8|
71856632|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.63|||TWO_SIDED|95.0|-2.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.6|-2.0|
71856633|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-1.9|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events||0.5|-1.9|
71856634|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-2.0|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.4|-2.0|
71856635|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.56|||TWO_SIDED|95.0|-2.1|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events||0.2|-2.1|
71856636|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-2.2|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||0.1|-2.2|
71905814|NCT00696436|143333880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.011|TWO_SIDED|95.0|-2.99|-0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.40|-2.99|0.011
71905815|NCT00696436|143333880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35|||<|0.001|TWO_SIDED|95.0|-3.67|-1.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.02|-3.67|<0.001
71905816|NCT00696436|143333880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.166|TWO_SIDED|95.0|-2.19|0.38||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.38|-2.19|0.166
71905817|NCT00696436|143333880|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.02|TWO_SIDED|95.0|-2.88|-0.24||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.24|-2.88|0.020
71905818|NCT00696436|143333881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.51|||<|0.001|TWO_SIDED|95.0|-9.33|-5.69||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.69|-9.33|<0.001
71905819|NCT00696436|143333881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.21|||<|0.001|TWO_SIDED|95.0|-8.03|-4.39||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-4.39|-8.03|<0.001
71905820|NCT00696436|143333881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.18||||0.005|TWO_SIDED|95.0|-3.69|-0.67||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.67|-3.69|0.005
71905821|NCT00696436|143333881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||<|0.001|TWO_SIDED|95.0|-4.69|-1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.64|-4.69|<0.001
71905822|NCT00696436|143333881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.257|TWO_SIDED|95.0|-2.39|0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.64|-2.39|0.257
71681125|NCT00772005|142881128|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0063
71856637|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|95.0|-2.2|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events||-0.0|-2.2|
71856638|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61|||TWO_SIDED|95.0|-2.1|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||0.4|-2.1|
71856639|NCT01568112|143227101|SUPERIORITY_OR_OTHER||Mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.58|||TWO_SIDED|95.0|-2.4|-0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events||-0.1|-2.4|
71856640|NCT01568112|143227102|SUPERIORITY_OR_OTHER||Difference in percentage|-12.0|||||TWO_SIDED|95.0|-32.2|9.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||9.5|-32.2|
71856641|NCT01568112|143227102|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events||27.8|-14.1|
71856642|NCT01568112|143227103|SUPERIORITY_OR_OTHER||Difference in percentage|-22.0|||||TWO_SIDED|95.0|-41.0|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||0.1|-41.0|
71905823|NCT00696436|143333881|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.017|TWO_SIDED|95.0|-3.39|-0.33||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.33|-3.39|0.017
71856643|NCT01568112|143227103|SUPERIORITY_OR_OTHER||Difference in percentage|7.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
71856644|NCT01568112|143227104|SUPERIORITY_OR_OTHER||Difference in percentage|-20.0|||||TWO_SIDED|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||3.8|-40.6|
71856645|NCT01568112|143227104|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-24.7|
71856646|NCT01568112|143227105|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-22.0|22.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||22.0|-22.0|
71856647|NCT01568112|143227105|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.5|-16.4|
71856648|NCT01568112|143227106|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-24.2|19.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||19.7|-24.2|
71856649|NCT01568112|143227106|SUPERIORITY_OR_OTHER||Difference in percentage|-3.0|||||TWO_SIDED|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.7|-23.3|
71856650|NCT01568112|143227107|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-29.4|17.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||17.1|-29.4|
71856651|NCT01568112|143227107|SUPERIORITY_OR_OTHER||Difference in percentage|1.0|||||TWO_SIDED|95.0|-22.1|24.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||24.5|-22.1|
71856652|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-1.1|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||1.1|-1.1|
71856653|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.1|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.9|-1.1|
71856654|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.57|||TWO_SIDED|95.0|-1.4|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.8|-1.4|
71856655|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.1|-1.7|
71856656|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|95.0|-0.5|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.6|-0.5|
71856657|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.5|||TWO_SIDED|95.0|-0.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||1.3|-0.7|
71856658|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.0|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.9|-1.0|
71856659|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.1|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.8|-1.1|
71856660|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.7|-0.6|
71856661|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|95.0|-0.6|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.5|-0.6|
71856662|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|95.0|-1.0|0.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.3|-1.0|
71856663|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.8|-0.8|
71856664|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-1.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-1.0|
71856665|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.9|-0.8|
71856666|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.7|1.1||||||Bloating||1.1|-0.7|
71856667|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|95.0|-0.9|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.9|
71856668|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.9|-0.8|
71856669|NCT01568112|143227108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-0.7|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||1.1|-0.7|
71856670|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.0|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-1.0|
71856671|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.8|-0.8|
71856672|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|95.0|-1.7|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.4|-1.7|
71856673|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.46|||TWO_SIDED|95.0|-1.7|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||0.2|-1.7|
71856674|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.7|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.6|-0.7|
71905824|NCT00696436|143333882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||<|0.001|TWO_SIDED|95.0|-17.3|-12.54||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.54|-17.30|<0.001
71856675|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||0.8|-0.7|
71856676|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||0.7|-0.6|
71856677|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.2|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||1.3|-0.2|
71856678|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.4|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.4|-0.4|
71856679|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||0.2|-0.4|
71856680|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.32|||TWO_SIDED|95.0|-0.6|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.6|-0.6|
71856681|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.7|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||0.5|-0.7|
71856682|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-0.1|1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||1.0|-0.1|
71856683|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|95.0|-0.2|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||0.6|-0.2|
71856684|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|95.0|-0.8|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.7|-0.8|
71681126|NCT00772005|142881129|SUPERIORITY_OR_OTHER|||||||0.0619||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0619
71856685|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||0.8|-0.7|
71856686|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|95.0|-1.6|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||-0.0|-1.6|
71905825|NCT00696436|143333882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.63|||<|0.001|TWO_SIDED|95.0|-15.99|-11.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.27|-15.99|<0.001
71905826|NCT00696436|143333882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.86||||0.005|TWO_SIDED|95.0|-4.85|-0.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.87|-4.85|0.005
71905827|NCT00696436|143333882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||<|0.001|TWO_SIDED|95.0|-6.8|-2.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.73|-6.80|<0.001
71905828|NCT00696436|143333882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.119|TWO_SIDED|95.0|-3.55|0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.40|-3.55|0.119
71856687|NCT01568112|143227109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|95.0|-1.2|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||0.5|-1.2|
71856688|NCT01568112|143227110|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
71856689|NCT01568112|143227110|SUPERIORITY_OR_OTHER||Difference in percentage|9.0|||||TWO_SIDED|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||30.0|-11.8|
71856690|NCT01568112|143227111|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-18.8|23.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.3|-18.8|
71856691|NCT01568112|143227111|SUPERIORITY_OR_OTHER||Difference in percentage|6.0|||||TWO_SIDED|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||27.8|-14.1|
71856692|NCT01568112|143227112|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-32.1|14.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||14.3|-32.1|
71856693|NCT01568112|143227112|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-25.0|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||21.7|-25.0|
71856694|NCT01568112|143227119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|13.79|||TWO_SIDED|95.0|-20.9|34.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||34.1|-20.9|
71856695|NCT01568112|143227119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|10.03|||TWO_SIDED|95.0|-14.2|25.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||25.7|-14.2|
71856696|NCT01568112|143227120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.2|STANDARD_ERROR_OF_MEAN|24.4|||TWO_SIDED|95.0|-26.5|70.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||70.9|-26.5|
71856697|NCT01568112|143227120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|11.08|||TWO_SIDED|95.0|-20.5|23.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||23.6|-20.5|
71681127|NCT00772005|142881129|SUPERIORITY_OR_OTHER|||||||0.1137||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1137
71856698|NCT01568112|143227121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.5|STANDARD_ERROR_OF_MEAN|13.32|||TWO_SIDED|95.0|-9.2|44.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||44.2|-9.2|
71856699|NCT01568112|143227121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|8.8|||TWO_SIDED|95.0|-17.2|18.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|||18.0|-17.2|
71856700|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.96|STANDARD_ERROR_OF_MEAN|4.601|||TWO_SIDED|95.0|-6.34|12.26|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||12.26|-6.34|
71856701|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|2.347|||TWO_SIDED|95.0|-8.81|0.67|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.67|-8.81|
71856702|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.74|STANDARD_ERROR_OF_MEAN|7.335|||TWO_SIDED|95.0|-3.15|26.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||26.63|-3.15|
71856703|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|2.321|||TWO_SIDED|95.0|-2.67|6.77|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||6.77|-2.67|
71681128|NCT00772005|142881129|SUPERIORITY_OR_OTHER|||||||0.0598||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0598
71681129|NCT00772005|142881130|SUPERIORITY_OR_OTHER|||||||0.7093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7093
71856704|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.21|STANDARD_ERROR_OF_MEAN|7.812|||TWO_SIDED|95.0|-6.72|25.14|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||25.14|-6.72|
71856705|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.84|STANDARD_ERROR_OF_MEAN|4.152|||TWO_SIDED|95.0|-11.31|5.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||5.63|-11.31|
71681130|NCT00772005|142881130|SUPERIORITY_OR_OTHER|||||||0.5129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5129
71856706|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|7.516|||TWO_SIDED|95.0|-18.36|12.19|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||12.19|-18.36|
71856707|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.18|STANDARD_ERROR_OF_MEAN|7.141|||TWO_SIDED|95.0|-20.71|8.35|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.35|-20.71|
71856708|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21|STANDARD_ERROR_OF_MEAN|5.292|||TWO_SIDED|95.0|-22.9|6.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||6.49|-22.90|
71856709|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.33|STANDARD_ERROR_OF_MEAN|6.536|||TWO_SIDED|95.0|-30.13|11.47|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||11.47|-30.13|
71856710|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.69|STANDARD_ERROR_OF_MEAN|8.376|||TWO_SIDED|95.0|-30.02|4.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||4.63|-30.02|
71856711|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|STANDARD_ERROR_OF_MEAN|8.654|||TWO_SIDED|95.0|-29.48|6.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.32|-29.48|
71856712|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|STANDARD_ERROR_OF_MEAN|10.274|||TWO_SIDED|95.0|-35.44|7.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||7.57|-35.44|
71856713|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|12.369|||TWO_SIDED|95.0|-33.39|18.81|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||18.81|-33.39|
71856714|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|6.472|||TWO_SIDED|95.0|-20.4|5.93|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||5.93|-20.40|
71856715|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.33|STANDARD_ERROR_OF_MEAN|34.455|||TWO_SIDED|95.0|-10.78|131.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||131.4|-10.78|
71856716|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|59.87|STANDARD_ERROR_OF_MEAN|65.007|||TWO_SIDED|95.0|-71.51|191.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||191.2|-71.51|
71856717|NCT01568112|143227122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.78|STANDARD_ERROR_OF_MEAN|40.44|||TWO_SIDED|95.0|-27.09|136.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||136.6|-27.09|
71856718|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|STANDARD_ERROR_OF_MEAN|5.281|||TWO_SIDED|95.0|-6.79|14.68|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||14.68|-6.79|
71856719|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|2.563|||TWO_SIDED|95.0|-9.57|0.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||0.83|-9.57|
71856720|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.51|STANDARD_ERROR_OF_MEAN|8.024|||TWO_SIDED|95.0|-2.84|29.86|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||29.86|-2.84|
71882328|NCT04474795|143283593|SUPERIORITY||||||<|0.0001|||||||Wilcoxon paired signed rank test|||Comparison of scores pre and post training in individuals who completed training modules||||<0.0001
71856721|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_ERROR_OF_MEAN|2.379|||TWO_SIDED|95.0|-2.41|7.29|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||7.29|-2.41|
71856722|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.84|STANDARD_ERROR_OF_MEAN|8.143|||TWO_SIDED|95.0|-5.81|27.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||27.50|-5.81|
71856723|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|4.671|||TWO_SIDED|95.0|-12.08|7.09|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||7.09|-12.08|
71856724|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|8.488|||TWO_SIDED|95.0|-19.03|15.64|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||15.64|-19.03|
71856725|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|STANDARD_ERROR_OF_MEAN|7.832|||TWO_SIDED|95.0|-23.93|8.11|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||8.11|-23.93|
71856726|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|4.811|||TWO_SIDED|95.0|-23.8|17.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||17.60|-23.80|
71856727|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.88|STANDARD_ERROR_OF_MEAN|4.155|||TWO_SIDED|95.0|-22.75|13.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting||13.00|-22.75|
71905829|NCT00696436|143333882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-5.49|-1.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.45|-5.49|<0.001
71905830|NCT00696436|143333883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.81|||<|0.001|TWO_SIDED|95.0|-11.48|-8.13||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.13|-11.48|<0.001
71905831|NCT00696436|143333883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.96|||<|0.001|TWO_SIDED|95.0|-10.63|-7.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.30|-10.63|<0.001
71905832|NCT00696436|143333883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99||||0.006|TWO_SIDED|95.0|-3.39|-0.58||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.58|-3.39|0.006
71905833|NCT00696436|143333883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57|||<|0.001|TWO_SIDED|95.0|-4.0|-1.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.14|-4.00|<0.001
71905834|NCT00696436|143333883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.107|TWO_SIDED|95.0|-2.53|0.25||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.25|-2.53|0.107
71905835|NCT00696436|143333883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73||||0.017|TWO_SIDED|95.0|-3.15|-0.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.30|-3.15|0.017
71905836|NCT00696436|143333884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.56|-10.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.45|-15.56|<0.001
71856728|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.08|STANDARD_ERROR_OF_MEAN|16.243|||TWO_SIDED|95.0|-59.2|9.05|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||9.05|-59.20|
71856729|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.95|STANDARD_ERROR_OF_MEAN|14.83|||TWO_SIDED|95.0|-54.89|6.98|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||6.98|-54.89|
71856730|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.49|STANDARD_ERROR_OF_MEAN|10.847|||TWO_SIDED|95.0|-35.38|10.39|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||10.39|-35.38|
71856731|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|STANDARD_ERROR_OF_MEAN|12.542|||TWO_SIDED|95.0|-32.79|20.13|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||20.13|-32.79|
71856732|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|STANDARD_ERROR_OF_MEAN|6.442|||TWO_SIDED|95.0|-15.87|10.41|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||10.41|-15.87|
71856733|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|81.89|STANDARD_ERROR_OF_MEAN|50.239|||TWO_SIDED|95.0|-22.04|185.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||185.8|-22.04|
71856734|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.52|STANDARD_ERROR_OF_MEAN|32.896|||TWO_SIDED|95.0|-40.13|93.18|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||93.18|-40.13|
71856735|NCT01568112|143227123|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.78|STANDARD_ERROR_OF_MEAN|41.055|||TWO_SIDED|95.0|-31.65|135.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||135.2|-31.65|
71856736|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|2.626|||TWO_SIDED|95.0|-7.35|3.99|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||3.99|-7.35|
71856737|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-6.62|2.62|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea||2.62|-6.62|
71856738|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|5.717|||TWO_SIDED|95.0|-11.64|12.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea||12.49|-11.64|
71856739|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.48|STANDARD_ERROR_OF_MEAN|4.597|||TWO_SIDED|95.0|-14.11|5.14||||||Diarrhea||5.14|-14.11|
71856740|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|0.794|||TWO_SIDED|95.0|-1.1|2.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.57|-1.10|
71856741|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.775|||TWO_SIDED|95.0|-1.17|2.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain||2.40|-1.17|
71856742|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|1.705|||TWO_SIDED|95.0|-5.08|2.79|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||2.79|-5.08|
71856743|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|27.886|||TWO_SIDED|95.0|-42.19|79.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain||79.32|-42.19|
71856744|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.46|STANDARD_ERROR_OF_MEAN|2.801|||TWO_SIDED|95.0|-3.65|8.56|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||8.56|-3.65|
71856745|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.242|||TWO_SIDED|95.0|-3.71|1.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion||1.83|-3.71|
71856746|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|19.649|||TWO_SIDED|95.0|-48.73|60.38|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||60.38|-48.73|
71856747|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|11.219|||TWO_SIDED|95.0|-28.38|33.91|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation||33.91|-28.38|
71856748|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.36|STANDARD_ERROR_OF_MEAN|9.811|||TWO_SIDED|95.0|-35.56|6.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||6.83|-35.56|
71856749|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.12|STANDARD_ERROR_OF_MEAN|41.961|||TWO_SIDED|95.0|-22.88|157.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating||157.1|-22.88|
71856750|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|98.65|STANDARD_ERROR_OF_MEAN|74.566|||TWO_SIDED|95.0|-58.01|255.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||255.3|-58.01|
71856751|NCT01568112|143227124|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.27|STANDARD_ERROR_OF_MEAN|7.928|||TWO_SIDED|95.0|-5.22|27.76|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence||27.76|-5.22|
71856752|NCT01182103|143227232|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71856753|NCT01182103|143227233|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71856754|NCT01182103|143227234|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71856755|NCT01670188|143227243|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71856756|NCT03455218|143227248|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71856757|NCT03455218|143227250|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
71856758|NCT03455218|143227251|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71856759|NCT03455218|143227252|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71856760|NCT03455218|143227253|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71856761|NCT03455218|143227254|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71856762|NCT03455218|143227255|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71856763|NCT03455218|143227257|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71856764|NCT03455218|143227258|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71856765|NCT03455218|143227259|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||||||0.71
71856766|NCT03455218|143227260|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71856767|NCT03455218|143227261|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71856768|NCT03455218|143227262|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.0
71856769|NCT03455218|143227263|SUPERIORITY|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71856770|NCT05324007|143227356|EQUIVALENCE|Estimated effect size was based on Liberman et al. (2017) that found a partial eta squared of .478 for the interaction between different-language and same-language conditions. Using G\*power using an alpha of .05, our target sample size of 30 per condition should provide 99.73% power to detect the main effect in the White-White and Black-Black condition and 99.99% power to detect the main effect in the Black-White condition.|partial eta squared|0.062|||<|0.05|TWO_SIDED||||||ANOVA|||We will examine whether looking time at affiliation will be greater when looking at Black-White interactions than at White-White or Black-Black interactions. That is, we will test if infants will be more surprised (look longer) by affiliation between different-race people interacting than same race people interacting. We will conduct a mixed ANOVA with conditions (Black-White, White-White, Black-Black) as a between-subject and test type (affiliation vs. disengagement) as within-subject factors.||||<.05
71856771|NCT00510146|143227375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.018|TWO_SIDED|95.0|-3.93|-0.36||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in MADRS total score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.36|-3.93|0.018
71856772|NCT00510146|143227376|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic response at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.050
71856773|NCT00510146|143227377|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic remission at any time from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.367
71856774|NCT00510146|143227378|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.11||||0.008|TWO_SIDED|95.0|-0.2|-0.03||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Mania score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.03|-0.20|0.008
71882329|NCT04474795|143283594|SUPERIORITY|||||||0.606|||||||Wilcoxon paired signed rank test|||Patient autonomy||||0.606
71882330|NCT04474795|143283594|SUPERIORITY|||||||0.003|||||||Wilcoxon paired signed rank test|||Value of tight control||||0.003
71882331|NCT04474795|143283594|SUPERIORITY|||||||0.475|||||||Wilcoxon paired signed rank test|||Need for Special Training||||0.475
71681131|NCT00772005|142881130|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1097
71681132|NCT00772005|142881131|SUPERIORITY_OR_OTHER|||||||0.4291||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4291
71681133|NCT00772005|142881131|SUPERIORITY_OR_OTHER|||||||0.3195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3195
71856775|NCT00510146|143227378|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.24||||0.037|TWO_SIDED|95.0|-0.47|-0.01||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.01|-0.47|0.037
71856776|NCT00510146|143227378|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.008|TWO_SIDED|95.0|-0.53|-0.08||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.08|-0.53|0.008
71856777|NCT00510146|143227379|SUPERIORITY_OR_OTHER|||||||0.156||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with recovery from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel|||||||0.156
71856778|NCT00510146|143227380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||<|0.001|TWO_SIDED|95.0|-1.56|-0.43||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.43|-1.56|<0.001
71856779|NCT00510146|143227381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21||||0.002|TWO_SIDED|95.0|-3.61|-0.81||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||-0.81|-3.61|0.002
71856780|NCT00510146|143227382|SUPERIORITY_OR_OTHER|||||||0.297||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.297
71856781|NCT00510146|143227382|SUPERIORITY_OR_OTHER|||||||0.264||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.264
71856782|NCT00510146|143227383|SUPERIORITY_OR_OTHER|||||||0.195||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current hypomanic episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.195
71681134|NCT00772005|142881131|SUPERIORITY_OR_OTHER|||||||0.1591||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1591
71856783|NCT00510146|143227384|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current psychotic disorders from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.163
71856784|NCT00510146|143227384|SUPERIORITY_OR_OTHER|||||||0.442||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.442
71856785|NCT00510146|143227385|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol dependence from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||1.00
71856786|NCT00510146|143227385|SUPERIORITY_OR_OTHER|||||||0.324||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.324
71856787|NCT00510146|143227387|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with emergence of mania at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.031
71681135|NCT00772005|142881132|SUPERIORITY_OR_OTHER|||||||0.7768||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7768
71681136|NCT00772005|142881132|SUPERIORITY_OR_OTHER|||||||0.4014||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4014
71856788|NCT00510146|143227388|SUPERIORITY_OR_OTHER|||||||0.269||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (akathisia) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.269
71882332|NCT04474795|143283595|SUPERIORITY|||||||0.009|||||||Wilcoxon paired signed rank test|||||||0.009
71882333|NCT04041284|143283598|OTHER||LS mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.16|-1.21|||ANCOVA|||||-1.21|-3.16|<0.0001
71882334|NCT04041284|143283599|OTHER||LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.61||0.0205|TWO_SIDED|95.0|-2.61|-0.22|||Mixed Models Analysis|||||-0.22|-2.61|0.0205
71882335|NCT04041284|143283600|OTHER||Odds Ratio (OR)|3.26|||<|0.0001|TWO_SIDED|95.0|1.89|5.62|||Regression, Logistic|||||5.62|1.89|<0.0001
71882336|NCT04041284|143283601|OTHER||LS mean difference|11.3|STANDARD_ERROR_OF_MEAN|2.21|<|0.0001|TWO_SIDED|95.0|6.91|15.59|||Mixed Models Analysis||Restrictive score: Fremanezumab versus placebo|||15.59|6.91|<0.0001
71681137|NCT00772005|142881132|SUPERIORITY_OR_OTHER|||||||0.4016||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4016
71856789|NCT00510146|143227388|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel|||||||0.736
71856790|NCT00510146|143227389|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
71856791|NCT00510146|143227389|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.249
71856792|NCT00510146|143227389|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.146
71856793|NCT00510146|143227389|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.271
71856794|NCT00510146|143227389|SUPERIORITY_OR_OTHER|||||||0.284||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.284
71856795|NCT00510146|143227389|SUPERIORITY_OR_OTHER|||||||0.067||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.067
71856796|NCT00510146|143227390|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in weight from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
71856797|NCT00510146|143227391|SUPERIORITY_OR_OTHER|||||||0.179||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in fasting glucose from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.179
71856798|NCT00510146|143227391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
71856799|NCT00510146|143227391|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.003
71856800|NCT00510146|143227391|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||<0.001
71856801|NCT00510146|143227391|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.095
71856802|NCT00510146|143227392|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in albumin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
71856803|NCT00510146|143227393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in ALT/SGPT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856804|NCT00510146|143227393|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
71856805|NCT00510146|143227393|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856806|NCT00510146|143227394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in direct bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856807|NCT00510146|143227394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856808|NCT00510146|143227394|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856809|NCT00510146|143227395|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in erythrocyte count from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.003
71856810|NCT00510146|143227396|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hematocrit from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.001
71856811|NCT00510146|143227397|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin A1c from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||0.009
71882337|NCT04041284|143283601|OTHER||LS mean difference|9.9|STANDARD_ERROR_OF_MEAN|2.12|<|0.0001|TWO_SIDED|95.0|5.73|14.08|||Mixed Models Analysis||Preventive score: Fremanezumab versus placebo|||14.08|5.73|<0.0001
71882338|NCT04041284|143283602|OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0915|TWO_SIDED|95.0|-0.39|0.03|||Mixed Models Analysis||Change at Week 4: Fremanezumab versus Placebo|||0.03|-0.39|0.0915
71856812|NCT00510146|143227398|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856813|NCT00510146|143227399|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in prolactin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856814|NCT00510146|143227400|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in urinalysis-specific gravity from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856815|NCT00510146|143227401|SUPERIORITY_OR_OTHER|||||||0.104||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcF interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.104
71856816|NCT00510146|143227401|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.006
71856817|NCT00510146|143227402|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in heart rate from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||||0.035
71856818|NCT00510146|143227403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.943|TWO_SIDED|95.0|-0.59|0.64||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint for MINI Suicidality Total Score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA|||||0.64|-0.59|0.943
71856819|NCT00510146|143227411|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||p-value represents change from baseline to endpoint-standing diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.736
71856820|NCT00510146|143227411|SUPERIORITY_OR_OTHER|||||||0.944||95.0||||p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.944
71856821|NCT00510146|143227411|SUPERIORITY_OR_OTHER|||||||0.08||95.0||||p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.080
71856822|NCT00510146|143227411|SUPERIORITY_OR_OTHER|||||||0.612||95.0||||p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.612
71856823|NCT00510146|143227411|SUPERIORITY_OR_OTHER|||||||0.64||95.0||||p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.640
71856824|NCT00510146|143227411|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change.|t-test, 2 sided|||||||0.122
71856825|NCT00510146|143227412|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for weight from t-tests on change.|t-test, 2 sided|||||||<0.001
71856826|NCT00510146|143227413|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for albumin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856827|NCT00510146|143227413|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
71856828|NCT00510146|143227414|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value represents change from baseline to endpoint for alkaline phosphatase from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.002
71856829|NCT00510146|143227414|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
71856830|NCT00510146|143227414|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.354
71856831|NCT00510146|143227415|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value represents change from baseline to endpoint for chlorine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.010
71856832|NCT00510146|143227416|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for creatinine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856833|NCT00510146|143227417|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||p-value represents change from baseline to endpoint for erythrocyte count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.021
71856834|NCT00510146|143227418|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||p-value represents change from baseline to endpoint for hemoglobin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.035
71856835|NCT00510146|143227419|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||p-value represents change from baseline to endpoint for platelet count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||0.024
71856836|NCT00510146|143227420|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for prolactin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856837|NCT00510146|143227421|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for uric acid from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)|||||||<0.001
71856838|NCT00510146|143227422|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value represents change from baseline to endpoint for fasting glucose from t-tests on change.|t-test, 2 sided|||||||0.047
71856839|NCT00510146|143227422|SUPERIORITY_OR_OTHER|||||||0.13||95.0||||p-value represents change from baseline to endpoint for cholesterol from t-tests on change.|t-test, 2 sided|||||||0.130
71856840|NCT00510146|143227422|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||p-value represents change from baseline to endpoint for triglycerides from t-tests on change.|t-test, 2 sided|||||||0.055
71856841|NCT00510146|143227422|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change.|t-test, 2 sided|||||||0.049
71856842|NCT00510146|143227422|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change.|t-test, 2 sided|||||||<0.001
71856843|NCT00510146|143227423|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||p-value represents change from baseline to endpoint for QTcF from t-test.|t-test, 2 sided|||||||0.023
71856844|NCT00510146|143227423|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value represents change from baseline to endpoint for QTcB from t-test.|t-test, 2 sided|||||||0.044
71856845|NCT00510146|143227424|SUPERIORITY_OR_OTHER|||||||0.919||95.0||||p-value represents change from baseline to endpoint for heart rate from t-test.|t-test, 2 sided|||||||0.919
71856846|NCT02864342|143227470|OTHER||||||<|0.001|||||||Satterthwaite t-test|||The effect of medication reminders on Symbicort adherence was evaluated using a t-test. The equality of variances was also tested and as the variances were not equal, the Satterthwaite-t test was reported.||||<0.001
71856847|NCT00118703|143227487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094||||0.604|TWO_SIDED|95.0|-0.26|0.45|||ANCOVA|The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.||||0.45|-0.26|0.604
71856848|NCT00118703|143227488|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061||||0.729|TWO_SIDED|95.0|-0.29|0.41|||ANCOVA|The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.||||0.41|-0.29|0.729
71856849|NCT00118703|143227489|SUPERIORITY_OR_OTHER|||||||0.064|||||||Regression, Logistic|Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen||||||0.064
71856850|NCT00519285|143227510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.942||||0.3802|TWO_SIDED|95.6|0.822|1.08||A priori threshold for statistical significance was set to 0.044 using the O'Brien-Fleming alpha spending function to account for two interim analyses.|Log Rank|Log rank test stratified on ECOG Performance Status|Hazard ratio (HR) aflibercept versus placebo estimated from a Cox proportional hazard model stratified on ECOG Performance Status|"Null hypothesis: No difference between aflibercept and placebo~The study was designed to provide 90% power to detect a 1.25-fold increase in median survival with aflibercept compared to placebo at a overall one-sided significance level of 0.025 with 873 deaths."||1.08|0.822|0.3802
71856851|NCT01149876|143227521|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 2 sided|||||||0.05
71856852|NCT01149876|143227521|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||.25
71856853|NCT01149876|143227521|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||.48
71856854|NCT02920021|143227540|SUPERIORITY||Least Squares (LS) Mean Difference|60.046|STANDARD_ERROR_OF_MEAN|79.918||0.463|TWO_SIDED|95.0|-108.566|228.657|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||228.657|-108.566|0.463
71856855|NCT02920021|143227541|SUPERIORITY||LS Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.016||0.962|TWO_SIDED|95.0|-0.031|0.032|||ANCOVA|ANCOVA model with treatment as fixed effect and baseline value as covariate.|Treatment Difference = Etokimab - Placebo|||0.032|-0.031|0.962
71856856|NCT05400226|143227551|OTHER|Summary statistics of quantitative data, one-sided exact binomial test for null hypothesis, Clopper-Pearson method for 95% exact confidence intervals|Proportion|0.425|||<|0.0001|TWO_SIDED|95.0|0.27|0.591|||Exact Binomial Test||The Parameter Dispersion Value is the asymptotic standard error of the proportion.|Single arm open-label||0.591|0.270|< .0001
71856857|NCT05400226|143227552|OTHER||Proportion|0.85|||||TWO_SIDED|95.0|0.675|0.939||||||||0.939|0.675|
71856858|NCT05400226|143227553|OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.202|0.733||||||||0.733|0.202|
71856859|NCT05400226|143227554|OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.126|0.633||||||||0.633|0.126|
71856860|NCT05400226|143227555|OTHER||Proportion|0.773|||||TWO_SIDED|95.0|0.65|0.862||||||||0.862|0.650|
71856861|NCT02551692|143227569|OTHER||Partial sum of squares|855.65||||0.534|TWO_SIDED||||||ANOVA|||||||0.534
71856862|NCT02551692|143227570|OTHER||Partial sum of squares|29602.69||||0.26|TWO_SIDED||||||ANOVA|||||||0.26
71856863|NCT02551692|143227571|OTHER||Partial sum of squares|101.69||||0.318|TWO_SIDED||||||ANCOVA|||||||0.318
71856864|NCT00006436|143227610|SUPERIORITY|||||||0.1|||||||Two-tailed log rank test||||Compared the PFS of interim PET positive participants to the PFS of interim PET negative.|||0.10
71856865|NCT00835510|143227631|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Fisher Exact|two-sided||||||0.0127
71856866|NCT00835510|143227631|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Fisher Exact|two-sided||||||<0.0001
71856867|NCT00835510|143227636|NON_INFERIORITY_OR_EQUIVALENCE|The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.|Cure rate difference|-19.78||||||90.0|-30.27|-9.29||||||||-9.29|-30.27|
71856868|NCT01644188|143227660|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.8|||<|0.0001|TWO_SIDED|95.0|-34.4|-25.3||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.||-25.3|-34.4|<0.0001
71856869|NCT01644188|143227661|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.6|||<|0.0001|TWO_SIDED|95.0|-34.9|-26.2||Threshold for significance ≤0.05|Mixed Models Analysis||Alirocumab vs. ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-26.2|-34.9|<0.0001
71856870|NCT01644188|143227662|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.4|||<|0.0001|TWO_SIDED|95.0|-33.7|-25.1||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.1|-33.7|<0.0001
71856871|NCT01644188|143227663|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.7|||<|0.0001|TWO_SIDED|95.0|-33.8|-25.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.6|-33.8|<0.0001
71856872|NCT01644188|143227664|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.4|||<|0.0001|TWO_SIDED|95.0|-26.0|-18.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.8|-26|<0.0001
71856873|NCT01644188|143227665|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.0|||<|0.0001|TWO_SIDED|95.0|-26.5|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.6|-26.5|<0.0001
71856874|NCT01644188|143227666|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-26.9|-18.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.9|-26.9|<0.0001
71681138|NCT00772005|142881133|SUPERIORITY_OR_OTHER|||||||0.5612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5612
71681139|NCT00772005|142881133|SUPERIORITY_OR_OTHER|||||||0.9704||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9704
71681140|NCT00772005|142881133|SUPERIORITY_OR_OTHER|||||||0.2424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2424
71681141|NCT00772005|142881134|SUPERIORITY_OR_OTHER|||||||0.8847||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8847
71681142|NCT00772005|142881134|SUPERIORITY_OR_OTHER|||||||0.2958||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2958
71856875|NCT01644188|143227667|SUPERIORITY_OR_OTHER||LS Mean Difference|-23.5|||<|0.0001|TWO_SIDED|95.0|-27.2|-19.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.7|-27.2|<0.0001
71856876|NCT01644188|143227668|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.7|||<|0.0001|TWO_SIDED|95.0|-17.7|-11.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.7|-17.7|<0.0001
71905837|NCT00696436|143333884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.97|||<|0.001|TWO_SIDED|95.0|-14.51|-9.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.43|-14.51|<0.001
71681143|NCT00772005|142881134|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2660
71681144|NCT00772005|142881135|SUPERIORITY_OR_OTHER|||||||0.0524||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0524
71856877|NCT01644188|143227669|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.5|||<|0.0001|TWO_SIDED|95.0|-25.7|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-19.2|-25.7|<0.0001
71856878|NCT01644188|143227670|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.0|||<|0.0001|TWO_SIDED|95.0|-25.6|-18.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-18.3|-25.6|<0.0001
71905838|NCT00696436|143333884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.42||||0.194|TWO_SIDED|95.0|-3.56|0.72||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.72|-3.56|0.194
71681145|NCT00772005|142881135|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
71681146|NCT00772005|142881135|SUPERIORITY_OR_OTHER|||||||0.0084||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0084
71856879|NCT01644188|143227671|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|||<|0.0001|TWO_SIDED|95.0|-17.1|-11.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-11.6|-17.1|<0.0001
71882339|NCT04041284|143283602|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0006|TWO_SIDED|95.0|-0.59|-0.16|||Mixed Models Analysis||Change at Week 8: Fremanezumab versus Placebo|||-0.16|-0.59|0.0006
71882340|NCT04041284|143283602|OTHER||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.003|TWO_SIDED|95.0|-0.58|-0.12|||Mixed Models Analysis||Change at Week 12: Fremanezumab versus Placebo|||-0.12|-0.58|0.0030
71882341|NCT04041284|143283603|OTHER||LS mean difference|-3.6|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-5.15|-1.96|||Mixed Models Analysis|||||-1.96|-5.15|<0.0001
71681147|NCT00772005|142881136|SUPERIORITY_OR_OTHER|||||||0.3651||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3651
71681148|NCT00772005|142881136|SUPERIORITY_OR_OTHER|||||||0.0096||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0096
71681149|NCT00772005|142881136|SUPERIORITY_OR_OTHER|||||||0.0327||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0327
71681150|NCT00772005|142881137|SUPERIORITY_OR_OTHER|||||||0.2091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2091
71856880|NCT01644188|143227672|SUPERIORITY_OR_OTHER||LS Mean Difference|-31.2|||<|0.0001|TWO_SIDED|95.0|-36.3|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-26.1|-36.3|<0.0001
71856881|NCT01644188|143227673|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.4|||<|0.0001|TWO_SIDED|95.0|3.7|7.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by Logistic regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||7.9|3.7|<0.0001
71856882|NCT01644188|143227674|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.9|||<|0.0001|TWO_SIDED|95.0|3.9|8.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||8.8|3.9|<0.0001
71856883|NCT01644188|143227675|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.7|||<|0.0001|TWO_SIDED|95.0|-26.4|-17.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-17|-26.4|<0.0001
71856884|NCT01644188|143227676|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|||<|0.0001|TWO_SIDED|95.0|5.4|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||10.7|5.4|<0.0001
71856885|NCT01644188|143227677|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.3||||0.9117|TWO_SIDED|95.0|-5.1|4.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.6|-5.1|0.9117
71681151|NCT00772005|142881137|SUPERIORITY_OR_OTHER|||||||0.0706||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0706
71681152|NCT00772005|142881137|SUPERIORITY_OR_OTHER|||||||0.3052||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3052
71856886|NCT03713281|143227692|SUPERIORITY||Least-square mean|-0.131|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.208|-0.054|||Linear Mixed Model|Kenward and Roger modethod for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.10 logMAR.||-0.054|-0.208|
71856887|NCT03713281|143227693|SUPERIORITY||Least-square means|0.06|STANDARD_ERROR_OF_MEAN|0.0278|||TWO_SIDED|95.0|-0.017|0.137|||Linear Mixed Model|Kenward and Roger method for the demoninator degrees of freedom.||Statistically superiority will be concluded if the upper confidence limit will be less than 0.17 logMAR for near distance logMAR visual acuity.||0.137|-0.017|
71905839|NCT00696436|143333884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.001|TWO_SIDED|95.0|-5.84|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.84|0.001
71856888|NCT03677245|143227750|OTHER|Wilcoxon signed ranks test used to compared pre-intervention to post-intervention means of the Pediatric Balance Scale. No power calculation performed or utilized.|Mean Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71856889|NCT01049984|143227780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.012|TWO_SIDED|95.0|-4.3|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-4.3|0.012
71681153|NCT00772005|142881138|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9960
71681154|NCT00772005|142881138|SUPERIORITY_OR_OTHER|||||||0.3604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3604
71856890|NCT01049984|143227781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.301|TWO_SIDED|95.0|-1.1|0.3||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||0.3|-1.1|0.301
71856891|NCT01049984|143227782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.007|TWO_SIDED|95.0|-3.1|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.||||-0.5|-3.1|0.007
71856892|NCT01049984|143227783|SUPERIORITY_OR_OTHER|||||||0.255||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.255
71856893|NCT01049984|143227784|SUPERIORITY_OR_OTHER|||||||0.996||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.||||||0.996
71856894|NCT01049984|143227785|SUPERIORITY_OR_OTHER|||||||0.967||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (\>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment, pooled center, and baseline value as strata.||||||0.967
71856895|NCT00225277|143227886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.886||||0.002||95.0|-1.448|-0.325|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way analysis of covariance (ANCOVA), treatment and center effects with baseline value as covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.||-0.3250|-1.4480|0.002
71856896|NCT00225277|143227887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.048||||0.064||95.0|-8.3336|0.2374|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way ANCOVA, treatment and center effects with baseline value as covariate. LS mean of the treatment difference reported.||0.2374|-8.3336|0.064
71856897|NCT00225277|143227888|SUPERIORITY_OR_OTHER|||||||0.744||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.744
71856898|NCT00225277|143227889|SUPERIORITY_OR_OTHER|||||||0.883||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.883
71856899|NCT00225277|143227890|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank|||||||0.663
71856900|NCT00527514|143228002|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
71856901|NCT00527514|143228003|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||Statistical analysis parameters apply to both the daytime and nighttime rows.||||<0.0001
71856902|NCT00527514|143228004|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
71856903|NCT00527514|143228005|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
71856904|NCT00527514|143228006|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|One-sample t-test|||||||<0.0001
71856905|NCT00527514|143228007|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||||||<0.0001
71856906|NCT00812838|143228008|SUPERIORITY|||||||0.5154||||||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|t-test, 2 sided|||||||0.5154
71856907|NCT00812838|143228009|SUPERIORITY|||||||0.3009||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||"This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.~This analysis pertains to both categories"||||0.3009
71856908|NCT00812838|143228010|SUPERIORITY|||||||0.0166||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0166
71856909|NCT00812838|143228011|SUPERIORITY|||||||0.8566||||||Threshold for statistical significance was \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||.8566
71856910|NCT00812838|143228012|SUPERIORITY|||||||0.0286||||||Threshold for statistical significance is \<0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.||||0.0286
71856911|NCT04148521|143228013|SUPERIORITY||Odds Ratio (OR)|1.15||||0.27|TWO_SIDED|95.0|0.9|1.47|||Mixed Models Analysis|||||1.47|0.90|0.27
71856912|NCT04148521|143228014|SUPERIORITY||Odds Ratio (OR)|1.04||||0.83|TWO_SIDED|95.0|0.75|1.43|||Mixed Models Analysis|||||1.43|0.75|0.83
71856913|NCT04148521|143228015|SUPERIORITY||Odds Ratio (OR)|1.43||||0.12|TWO_SIDED|95.0|0.91|2.26|||Mixed Models Analysis|||||2.26|0.91|0.12
71856914|NCT04148521|143228016|SUPERIORITY||Odds Ratio (OR)|1.17||||0.51|TWO_SIDED|95.0|0.73|1.86|||Mixed Models Analysis|||||1.86|0.73|0.51
71856915|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-79.33|||<|0.001|TWO_SIDED|95.0|-87.54|-65.73|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-65.73|-87.54|< 0.001
71856916|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-71.16|||<|0.001|TWO_SIDED|95.0|-82.67|-52.0|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.00|-82.67|< 0.001
71856917|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-79.52|||<|0.001|TWO_SIDED|95.0|-88.29|-64.17|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.17|-88.29|< 0.001
71905840|NCT00696436|143333884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.72|TWO_SIDED|95.0|-2.51|1.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.73|-2.51|0.720
71905841|NCT00696436|143333884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.62||||0.018|TWO_SIDED|95.0|-4.79|-0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.45|-4.79|0.018
71905842|NCT00696436|143333885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.64|||<|0.001|TWO_SIDED|95.0|-10.42|-6.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-6.87|-10.42|<0.001
71681155|NCT00772005|142881138|SUPERIORITY_OR_OTHER|||||||0.9528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9528
71856918|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-72.34|||<|0.001|TWO_SIDED|95.0|-83.32|-54.13|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-54.13|-83.32|< 0.001
71856919|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-73.03|||<|0.001|TWO_SIDED|95.0|-83.79|-55.11|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-55.11|-83.79|< 0.001
71856920|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-71.88|||<|0.001|TWO_SIDED|95.0|-83.93|-50.82|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-50.82|-83.93|< 0.001
71856921|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-68.51|||<|0.001|TWO_SIDED|95.0|-81.01|-47.78|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-47.78|-81.01|< 0.001
71856922|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-81.06|||<|0.001|TWO_SIDED|95.0|-88.62|-68.49|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-68.49|-88.62|< 0.001
71856923|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-79.04|||<|0.001|TWO_SIDED|95.0|-88.02|-63.34|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-63.34|-88.02|< 0.001
71856924|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-32.7||||0.25|TWO_SIDED|95.0|-65.71|32.1|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||32.10|-65.71|0.25
71856925|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|3.44||||0.9|TWO_SIDED|95.0|-40.78|80.66|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||80.66|-40.78|0.90
71856926|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-40.53||||0.091|TWO_SIDED|95.0|-67.5|8.82|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||8.82|-67.50|0.091
71905843|NCT00696436|143333885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|||<|0.001|TWO_SIDED|95.0|-9.52|-5.99||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.99|-9.52|<0.001
71905844|NCT00696436|143333885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.341|TWO_SIDED|95.0|-2.21|0.77||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.77|-2.21|0.341
71856927|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|13.33||||0.73|TWO_SIDED|95.0|-44.39|130.94|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||130.94|-44.39|0.73
71905845|NCT00696436|143333885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28||||0.003|TWO_SIDED|95.0|-3.8|-0.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.76|-3.80|0.003
71681156|NCT00772005|142881139|SUPERIORITY_OR_OTHER|||||||0.9797||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9797
71905846|NCT00696436|143333885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.821|TWO_SIDED|95.0|-1.3|1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.64|-1.30|0.821
71905847|NCT00696436|143333885|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.071|TWO_SIDED|95.0|-2.89|0.12||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.12|-2.89|0.071
71856928|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-80.02||||0.001|TWO_SIDED|95.0|-91.53|-52.87|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.87|-91.53|0.001
71856929|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-87.6|||<|0.001|TWO_SIDED|95.0|-94.53|-71.88|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-71.88|-94.53|< 0.001
71856930|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Rratio|-79.81||||0.001|TWO_SIDED|95.0|-91.44|-52.37|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-52.37|-91.44|0.001
71856931|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-83.66|||<|0.001|TWO_SIDED|95.0|-92.79|-62.95|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-62.95|-92.79|< 0.001
71856932|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-81.97|||<|0.001|TWO_SIDED|95.0|-92.35|-57.46|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-57.46|-92.35|< 0.001
71856933|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-84.39|||<|0.001|TWO_SIDED|95.0|-93.12|-64.6|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-64.60|-93.12|< 0.001
71856934|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|43.1||||0.47|TWO_SIDED|95.0|-47.06|286.83|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||286.83|-47.06|0.47
71856935|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-68.58||||0.02|TWO_SIDED|95.0|-88.02|-17.63|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||-17.63|-88.02|0.020
71856936|NCT01723514|143228029|SUPERIORITY||LS Geometric Mean Ratio|-54.32||||0.11|TWO_SIDED|95.0|-82.58|19.75|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .||19.75|-82.58|0.11
71856937|NCT00014222|143228038|SUPERIORITY|||||||0.0007|||||||Log Rank|||||||0.0007
71856938|NCT00014222|143228039|SUPERIORITY|||||||0.084|||||||Log Rank|||||||0.084
71856939|NCT02970305|143228091|SUPERIORITY||Difference in MMRM LSMs|-1.9|STANDARD_ERROR_OF_MEAN|0.95||0.0434|TWO_SIDED|95.0|-3.8|-0.1|||Mixed-effects model for repeated measure|||||-0.1|-3.8|0.0434
71856940|NCT00983892|143228104|SUPERIORITY_OR_OTHER||Slope|-1.56||||0.03|TWO_SIDED|95.0|-2.97|-0.15|||GEE|Adjusting for baseline symptom severity, caregiver type, week number, and cancer site.||||-0.15|-2.97|0.030
71856941|NCT00988117|143228156|SUPERIORITY_OR_OTHER||Tscore|5.19|||<|0.01||95.0||||t-tests were statistically thresholded using the joint probability distribution method to correct for multiple comparisons, p \< 0.01 for voxel height and p \< 0.05 for cluster extent|t-test, 2 sided|A mask included only those regions where the patients showed abnormally low fALFF at either timepoint relative to a sample of 15 age-matched controls.||"Each voxel's BOLD signal time series was detrended and transformed to the frequency domain. We divided the sum of the square roots across the 0.01-0.08 Hz range by that across the entire frequency range (0-0.25 Hz).~fALFF group comparisons were evaluated using t-tests corrected for multiple comparisons. To determine if there were treatment-associated changes in brain activity, we compared voxel-wise fALFF in the patients at baseline to post-treatment."||||<0.01
71856942|NCT00988117|143228157|SUPERIORITY_OR_OTHER||pearson's r correlation coefficient|-0.82|||<|0.01||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left inferior frontal gyrus / premotor falff change||||<.01
71856943|NCT00988117|143228157|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|-0.35||||0.36||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.36
71856944|NCT00988117|143228158|SUPERIORITY_OR_OTHER||pearson's r correlation|0.18||||0.58||95.0|||||Regression, Linear|||correlation with left premotor / inferior frontal gyri falff change||||.58
71856945|NCT00988117|143228158|SUPERIORITY_OR_OTHER||pearson's correlation coefficient|0.26||||0.41||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change||||.41
71856946|NCT00702273|143228159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -8%|Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.6|7.4||||||Treatment groups were compared with a generalized linear model including covariates treatment group, age class and region.||7.4|-2.6|
71856947|NCT04522778|143228166|OTHER|||||||0.029|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.029
71856948|NCT04522778|143228167|SUPERIORITY|||||||0.35|||||||t-test, 1 sided|||A ratio of events per month was calculated for each participant. Participants were compared to themselves prior to intervention (i.e. event ratios pre intervention were compared to event ratios following intervention.)||||.35
71856949|NCT04522778|143228168|SUPERIORITY|||||||0.334|||||||t-test, 1 sided|||||||.334
71856950|NCT04522778|143228169|SUPERIORITY||Odds Ratio (OR)|38.26|STANDARD_ERROR_OF_MEAN|50.195||0.005|TWO_SIDED|95.0|2.926154|500.4402|||Chi-squared|||||500.4402|2.926154|.005
71856951|NCT04522778|143228170|SUPERIORITY||Odds Ratio (OR)|30.975|STANDARD_ERROR_OF_MEAN|35.73483||0.003|TWO_SIDED|95.0|3.22|297.17|||Chi-squared|||||297.17|3.22|.003
71856952|NCT04522778|143228171|SUPERIORITY||Odds Ratio (OR)|27.36|STANDARD_ERROR_OF_MEAN|31.72||0.004|TWO_SIDED|95.0|2.82|265.45|||Chi-squared|||||265.45|2.82|.004
71856953|NCT04522778|143228172|SUPERIORITY||Odds Ratio (OR)|10.93|STANDARD_ERROR_OF_MEAN|10.345||0.011|TWO_SIDED|95.0|1.71|69.82|||Chi-squared|||||69.82|1.71|.011
71856954|NCT04522778|143228173|SUPERIORITY||Odds Ratio (OR)|0.298|STANDARD_ERROR_OF_MEAN|0.2189||0.099|TWO_SIDED|95.0|0.0706|1.258|||Chi-squared|||||1.258|.0706|.099
71856955|NCT04522778|143228174|SUPERIORITY||Odds Ratio (OR)|1.201|STANDARD_ERROR_OF_MEAN|1.201||0.312|TWO_SIDED|95.0|0.549|6.562|||Chi-squared|||||6.562|.549|.312
71856956|NCT04522778|143228175|SUPERIORITY||Odds Ratio (OR)|1.519|STANDARD_ERROR_OF_MEAN|2.022||0.753|TWO_SIDED|95.0|0.112|20.623|||Chi-squared|||||20.623|.112|.753
71856957|NCT04522778|143228176|SUPERIORITY||Odds Ratio (OR)|0.321|STANDARD_ERROR_OF_MEAN|0.257||0.156|TWO_SIDED|95.0|0.067|1.541|||Chi-squared|||||1.541|.067|.156
71856958|NCT04522778|143228177|SUPERIORITY||Odds Ratio (OR)|0.458|STANDARD_ERROR_OF_MEAN|0.358||0.318|TWO_SIDED|95.0|0.099|2.122|||Chi-squared|||||2.122|.099|.318
71856959|NCT04522778|143228178|SUPERIORITY||Odds Ratio (OR)|0.449|STANDARD_ERROR_OF_MEAN|0.882||0.684|TWO_SIDED|95.0|0.009|21.003|||Chi-squared|||||21.003|.009|.684
71856960|NCT04522778|143228179|SUPERIORITY||Odds Ratio (OR)|2.335|STANDARD_ERROR_OF_MEAN|2.683||0.46|TWO_SIDED|95.0|0.246|22.194|||Chi-squared|||||22.194|.246|.460
71856961|NCT04522778|143228180|SUPERIORITY||Odds Ratio (OR)|2.299|STANDARD_ERROR_OF_MEAN|2.47293||0.439|TWO_SIDED|95.0|0.279|18.927|||Chi-squared|||||18.927|.279|.439
71856962|NCT04522778|143228181|SUPERIORITY||Odds Ratio (OR)|1.634|STANDARD_ERROR_OF_MEAN|2.187||0.714|TWO_SIDED|95.0|0.119|22.514|||Chi-squared|||||22.514|.119|.714
71856963|NCT04522778|143228182|SUPERIORITY||Odds Ratio (OR)|0.379|STANDARD_ERROR_OF_MEAN|0.448||0.412|TWO_SIDED|95.0|0.037|3.842|||Chi-squared|||||3.842|.037|.412
71856964|NCT04522778|143228183|SUPERIORITY||Odds Ratio (OR)|0.579|STANDARD_ERROR_OF_MEAN|0.539||0.558|TWO_SIDED|95.0|0.094|3.582|||Chi-squared|||||3.582|.094|.558
71856965|NCT04522778|143228184|SUPERIORITY||Odds Ratio (OR)|0.688|STANDARD_ERROR_OF_MEAN|0.609||0.673|TWO_SIDED|95.0|0.121|3.9|||Chi-squared|||||3.90|.121|.673
71856966|NCT04522778|143228185|SUPERIORITY||Odds Ratio (OR)|0.674|STANDARD_ERROR_OF_MEAN|0.438||0.544|TWO_SIDED|95.0|0.189|2.406|||Chi-squared|||||2.406|.189|.544
71856967|NCT04522778|143228186|SUPERIORITY||Odds Ratio (OR)|1.88|STANDARD_ERROR_OF_MEAN|1.631||0.464|TWO_SIDED|95.0|0.345|10.278|||Chi-squared|||||10.278|.345|.464
71856968|NCT04522778|143228187|SUPERIORITY||Odds Ratio (OR)|5.595|STANDARD_ERROR_OF_MEAN|5.675||0.09|TWO_SIDED|95.0|0.766|40.854|||Chi-squared|||||40.854|.766|.090
71856969|NCT04522778|143228188|SUPERIORITY||Odds Ratio (OR)|0.987|STANDARD_ERROR_OF_MEAN|1.119||0.991|TWO_SIDED|95.0|0.107|9.114|||Chi-squared|||||9.114|.107|.991
71856970|NCT04522778|143228189|SUPERIORITY||Odds Ratio (OR)|4.239|STANDARD_ERROR_OF_MEAN|5.027||0.223|TWO_SIDED|95.0|0.415|43.326|||Chi-squared|||||43.326|.415|.223
71856971|NCT04522778|143228190|SUPERIORITY||Odds Ratio (OR)|2.199|STANDARD_ERROR_OF_MEAN|2.496||0.488|TWO_SIDED|95.0|0.238|20.348|||Chi-squared|||||20.348|.238|.488
71856972|NCT04522778|143228191|SUPERIORITY||Odds Ratio (OR)|0.177|STANDARD_ERROR_OF_MEAN|0.129||0.018|TWO_SIDED|95.0|0.0424|0.743|||Chi-squared|||||.743|.0424|.018
71856973|NCT04522778|143228192|SUPERIORITY||Odds Ratio (OR)|3.688|STANDARD_ERROR_OF_MEAN|4.358||0.269|TWO_SIDED|95.0|0.364|37.379|||Chi-squared|||||37.379|.364|.269
71856974|NCT04522778|143228193|SUPERIORITY||Odds Ratio (OR)|4.251|STANDARD_ERROR_OF_MEAN|3.829||0.108|TWO_SIDED|95.0|0.728|24.84|||Chi-squared|||||24.84|.728|.108
71856975|NCT04522778|143228194|SUPERIORITY||Odds Ratio (OR)|3.658|STANDARD_ERROR_OF_MEAN|2.99||0.113|TWO_SIDED|95.0|0.737|18.157|||Chi-squared|||||18.157|.737|.113
71856976|NCT04522778|143228195|SUPERIORITY||Odds Ratio (OR)|2.495|STANDARD_ERROR_OF_MEAN|1.156||0.049|TWO_SIDED|95.0|1.004|6.202|||Chi-squared|||||6.202|1.004|.049
71856977|NCT00312845|143228198|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Log Rank|||||||0.039
71856978|NCT00312845|143228199|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71856979|NCT04159805|143228236|SUPERIORITY||Difference in Least Square (LS) Mean|0.29|||=|0.772|TWO_SIDED|95.0|-1.72|2.3||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.30|-1.72|=0.772
71856980|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|1.01|||=|0.299|TWO_SIDED|95.0|-0.94|2.97||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||2.97|-0.94|=0.299
71856981|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|-0.11|||=|0.924|TWO_SIDED|95.0|-2.34|2.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.13|-2.34|=0.924
71905848|NCT00696436|143333886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.45|||<|0.001|TWO_SIDED|95.0|-17.96|-12.94||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-12.94|-17.96|<0.001
71856982|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|1.86|||=|0.091|TWO_SIDED|95.0|-0.32|4.04||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.04|-0.32|=0.091
71856983|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|-0.18|||=|0.887|TWO_SIDED|95.0|-2.82|2.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-2.82|=0.887
71856984|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|1.8|||=|0.162|TWO_SIDED|95.0|-0.76|4.36||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.36|-0.76|=0.162
71856985|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|-0.36|||=|0.784|TWO_SIDED|95.0|-3.01|2.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||2.29|-3.01|=0.784
71856986|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|1.79|||=|0.166|TWO_SIDED|95.0|-0.79|4.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||4.37|-0.79|=0.166
71856987|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|0.42|||=|0.724|TWO_SIDED|95.0|-1.98|2.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.82|-1.98|=0.724
71856988|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|1.81|||=|0.124|TWO_SIDED|95.0|-0.52|4.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.14|-0.52|=0.124
71856989|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|0.29|||=|0.856|TWO_SIDED|95.0|-2.91|3.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||3.48|-2.91|=0.856
71856990|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|1.64|||=|0.292|TWO_SIDED|95.0|-1.48|4.76||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.76|-1.48|=0.292
71856991|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|0.11|||=|0.944|TWO_SIDED|95.0|-3.14|3.37||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.37|-3.14|=0.944
71856992|NCT04159805|143228236|SUPERIORITY||Difference in LS Mean|0.85|||=|0.589|TWO_SIDED|95.0|-2.33|4.02||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||4.02|-2.33|=0.589
71856993|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-0.93|||=|0.406|TWO_SIDED|95.0|-3.17|1.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||1.31|-3.17|=0.406
71856994|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|0.9|||=|0.418|TWO_SIDED|95.0|-1.34|3.14||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.14|-1.34|=0.418
71905849|NCT00696436|143333886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.93|||<|0.001|TWO_SIDED|95.0|-16.42|-11.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-11.43|-16.42|<0.001
71856995|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.463|TWO_SIDED|95.0|-3.53|1.65||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||1.65|-3.53|=0.463
71905850|NCT00696436|143333886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.002|TWO_SIDED|95.0|-5.42|-1.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.22|-5.42|0.002
71856996|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-0.1|||=|0.936|TWO_SIDED|95.0|-2.7|2.49||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||2.49|-2.70|=0.936
71856997|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-1.8|||=|0.17|TWO_SIDED|95.0|-4.41|0.82||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||0.82|-4.41|=0.170
71856998|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|0.52|||=|0.687|TWO_SIDED|95.0|-2.1|3.13||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.13|-2.10|=0.687
71856999|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-1.24|||=|0.374|TWO_SIDED|95.0|-4.05|1.57||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||1.57|-4.05|=0.374
71857000|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|0.99|||=|0.478|TWO_SIDED|95.0|-1.82|3.8||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.80|-1.82|=0.478
71857001|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-0.51|||=|0.69|TWO_SIDED|95.0|-3.12|2.09||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||2.09|-3.12|=0.690
71857002|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|2.12|||=|0.106|TWO_SIDED|95.0|-0.48|4.71||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.71|-0.48|=0.106
71857003|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-0.89|||=|0.547|TWO_SIDED|95.0|-3.89|2.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||2.12|-3.89|=0.547
71857004|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|2.19|||=|0.144|TWO_SIDED|95.0|-0.81|5.18||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.18|-0.81|=0.144
71857005|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|-1.37|||=|0.431|TWO_SIDED|95.0|-4.91|2.17||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||2.17|-4.91|=0.431
71857006|NCT04159805|143228237|SUPERIORITY||Difference in LS Mean|1.2|||=|0.488|TWO_SIDED|95.0|-2.34|4.74|||MMRM|||Change From Baseline at Week 16||4.74|-2.34|=0.488
71857007|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|-0.34|||=|0.855|TWO_SIDED|95.0|-4.14|3.45||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.45|-4.14|=0.855
71857008|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|3.19|||=|0.093|TWO_SIDED|95.0|-0.56|6.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||6.95|-0.56|=0.093
71857009|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|1.8|||=|0.41|TWO_SIDED|95.0|-2.61|6.2||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.20|-2.61|=0.410
71857010|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|3.13|||=|0.154|TWO_SIDED|95.0|-1.25|7.5||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||7.50|-1.25|=0.154
71857011|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|-0.94|||=|0.662|TWO_SIDED|95.0|-5.29|3.41||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||3.41|-5.29|=0.662
71857012|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|3.26|||=|0.13|TWO_SIDED|95.0|-1.02|7.54||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||7.54|-1.02|=0.130
71857013|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|1.27|||=|0.586|TWO_SIDED|95.0|-3.44|5.98||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||5.98|-3.44|=0.586
71857014|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|4.93|||=|0.039|TWO_SIDED|95.0|0.26|9.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||9.60|0.26|=0.039
71857015|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|-0.22|||=|0.909|TWO_SIDED|95.0|-4.03|3.6||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.60|-4.03|=0.909
71857016|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|2.65|||=|0.158|TWO_SIDED|95.0|-1.09|6.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||6.40|-1.09|=0.158
71857017|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|-0.88|||=|0.764|TWO_SIDED|95.0|-6.8|5.05||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||5.05|-6.80|=0.764
71857018|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|5.2|||=|0.08|TWO_SIDED|95.0|-0.67|11.06||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||11.06|-0.67|=0.080
71857019|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|-1.01|||=|0.677|TWO_SIDED|95.0|-5.98|3.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||3.95|-5.98|=0.677
71857020|NCT04159805|143228238|SUPERIORITY||Difference in LS Mean|4.81|||=|0.055|TWO_SIDED|95.0|-0.1|9.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||9.73|-0.10|=0.055
71857021|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|0.52|||=|0.78|TWO_SIDED|95.0|-3.23|4.27||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.27|-3.23|=0.780
71857022|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|0.5|||=|0.771|TWO_SIDED|95.0|-2.99|3.99||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||3.99|-2.99|=0.771
71857023|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-0.04|||=|0.984|TWO_SIDED|95.0|-4.22|4.14||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||4.14|-4.22|=0.984
71857024|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|2.44|||=|0.213|TWO_SIDED|95.0|-1.47|6.35||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||6.35|-1.47|=0.213
71857025|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-1.97|||=|0.371|TWO_SIDED|95.0|-6.4|2.45||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||2.45|-6.40|=0.371
71857026|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|0.11|||=|0.956|TWO_SIDED|95.0|-4.01|4.23||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||4.23|-4.01|=0.956
71857027|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-1.06|||=|0.641|TWO_SIDED|95.0|-5.65|3.53||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.53|-5.65|=0.641
71857028|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-0.33|||=|0.876|TWO_SIDED|95.0|-4.61|3.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||3.95|-4.61|=0.876
71857029|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-1.86|||=|0.458|TWO_SIDED|95.0|-6.91|3.18||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||3.18|-6.91|=0.458
71857030|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-0.68|||=|0.769|TWO_SIDED|95.0|-5.37|4.0||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||4.00|-5.37|=0.769
71857031|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|-1.14|||=|0.699|TWO_SIDED|95.0|-7.07|4.8||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||4.80|-7.07|=0.699
71857032|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|1.1|||=|0.687|TWO_SIDED|95.0|-4.41|6.62||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 14||6.62|-4.41|=0.687
71857033|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|0.2|||=|0.944|TWO_SIDED|95.0|-5.55|5.95||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||5.95|-5.55|=0.944
71857034|NCT04159805|143228239|SUPERIORITY||Difference in LS Mean|2.48|||=|0.351|TWO_SIDED|95.0|-2.87|7.83||From a MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 16||7.83|-2.87|=0.351
71905851|NCT00696436|143333886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||<|0.001|TWO_SIDED|95.0|-7.26|-2.97||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-2.97|-7.26|<0.001
71905852|NCT00696436|143333886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.091|TWO_SIDED|95.0|-3.88|0.29||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.29|-3.88|0.091
71857035|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-27.9|||=|0.09|TWO_SIDED|95.0|-60.18|4.38||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||4.38|-60.18|=0.090
71857036|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-15.77|||=|0.328|TWO_SIDED|95.0|-47.5|15.96||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 2||15.96|-47.50|=0.328
71857037|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-12.65|||=|0.441|TWO_SIDED|95.0|-44.94|19.63||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||19.63|-44.94|=0.441
71857038|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|1.39|||=|0.931|TWO_SIDED|95.0|-30.33|33.12||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 3||33.12|-30.33|=0.931
71857039|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-28.18|||=|0.087|TWO_SIDED|95.0|-60.46|4.11||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||4.11|-60.46|=0.087
71857040|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|4.44|||=|0.783|TWO_SIDED|95.0|-27.29|36.16||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 4||36.16|-27.29|=0.783
71857041|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-29.08|||=|0.077|TWO_SIDED|95.0|-61.36|3.21||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||3.21|-61.36|=0.077
71857042|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-15.72|||=|0.33|TWO_SIDED|95.0|-47.45|16.0||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 5||16.00|-47.45|=0.330
71857043|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-14.14|||=|0.4|TWO_SIDED|95.0|-47.19|18.91||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||18.91|-47.19|=0.400
71857044|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|0.0|||=|1|TWO_SIDED|95.0|-32.18|32.19||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 6||32.19|-32.18|=1.000
71857045|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-26.47|||=|0.117|TWO_SIDED|95.0|-59.64|6.69||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||6.69|-59.64|=0.117
71857046|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-12.75|||=|0.436|TWO_SIDED|95.0|-44.94|19.44||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 7||19.44|-44.94|=0.436
71857047|NCT04159805|143228240|SUPERIORITY|From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|Difference in LS Mean|-47.91|||=|0.005|TWO_SIDED|95.0|-81.54|-14.29||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||-14.29|-81.54|=0.005
71857048|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-20.48|||=|0.215|TWO_SIDED|95.0|-52.92|11.95||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 8||11.95|-52.92|=0.215
71857049|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-3.97|||=|0.815|TWO_SIDED|95.0|-37.34|29.4||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||29.40|-37.34|=0.815
71857050|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-4.31|||=|0.794|TWO_SIDED|95.0|-36.84|28.22||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 10||28.22|-36.84|=0.794
71857051|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-36.78|||=|0.033|TWO_SIDED|95.0|-70.48|-3.08||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Change From Baseline at Week 12||-3.08|-70.48|=0.033
71857052|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-10.79|||=|0.513|TWO_SIDED|95.0|-43.26|21.67||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 12||21.67|-43.26|=0.513
71857053|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-56.21|||=|0.002|TWO_SIDED|95.0|-91.69|-20.73||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-20.73|-91.69|=0.002
71857054|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-36.94|||=|0.036|TWO_SIDED|95.0|-71.39|-2.48||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 14||-2.48|-71.39|=0.036
71857055|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-62.98|||=|0.001|TWO_SIDED|95.0|-100.64|-25.31||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||-25.31|-100.64|=0.001
71857056|NCT04159805|143228240|SUPERIORITY||Difference in LS Mean|-28.81|||=|0.13|TWO_SIDED|95.0|-66.12|8.51||From MMRM analysis over all post-baseline visits, with the change from baseline as the outcome, treatment group, visit, and treatment-by-visit interaction as factors, and adjusted by baseline value and baseline-by-visit interaction.|MMRM|||Week 16||8.51|-66.12|=0.130
71857057|NCT04167085|143228245|SUPERIORITY|||||||0.16||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.16
71857058|NCT04167085|143228246|SUPERIORITY|||||||0.05||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.05
71857059|NCT04167085|143228247|SUPERIORITY|||||||0.19||||||Threshold p\<0.0167 - Because 3 primary outcomes were prespecified, the familywise error rate was adjusted for 3 endpoints: 0.05/3|Wilcoxon (Mann-Whitney)|||||||0.19
71857060|NCT04167085|143228248|SUPERIORITY|||||||0.24||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Physical||||0.24
71857061|NCT04167085|143228248|SUPERIORITY|||||||0.35||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||SF-12 Mental||||0.35
71857062|NCT04167085|143228249|SUPERIORITY|||||||0.5||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.50
71857063|NCT04167085|143228250|SUPERIORITY|||||||0.3||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||0.30
71857064|NCT04167085|143228251|SUPERIORITY|||||||1||||||Threshold p=0.05|Wilcoxon (Mann-Whitney)|||||||1.00
71857065|NCT01171183|143228253|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.52|STANDARD_DEVIATION|37.64||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71857066|NCT01171183|143228254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_DEVIATION|4.54||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71857067|NCT01268098|143228279|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|5.0|||>|0.999|TWO_SIDED|95.0|-20.6|30.7||All hypothesis testings in this study were based on type I error of 0.05. Adjustment for multiplicity was not applied.|Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference between the two dose arms.|The 2-sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis corresponding to the primary efficacy endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms. This sample size for this study was not based on the statistical considerations.||30.7|-20.6|>0.999
71857068|NCT01268098|143228280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.258|TWO_SIDED||||||Fisher Exact|The 2-sided Fisher's Exact test was utilized to test for difference betweenthe two dose arms.||The null hypothesis corresponding to this endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms.||||0.258
71857069|NCT01929876|143228285|SUPERIORITY_OR_OTHER||Ratio of least squares means|316.6|||||TWO_SIDED|90.0|268.1|374.0|||||LS means from analysis of variance (ANOVA), calculated by transforming the natural log means back to the linear scale (that is, geometric LS mean).|Ratio of Least squares (LS) means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent).||374.0|268.1|
71857070|NCT01929876|143228286|SUPERIORITY_OR_OTHER||Ratio of LS means|672.3|||||TWO_SIDED|90.0|563.7|801.9|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|Only participants with PK parameter data from both Period 1 Day 1 and Period 2 Day 4 (n=11) were included for statistical analyses.||801.9|563.7|
71857071|NCT01929876|143228288|SUPERIORITY_OR_OTHER||Ratio of LS means|583.9|||||TWO_SIDED|90.0|488.2|698.2|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|||698.2|488.2|
71857072|NCT01222533|143228321|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for Cmax,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|80.66|STANDARD_DEVIATION|43.4||0.4423||90.0|73.49|88.52||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||88.52|73.49|0.4423
71857073|NCT01222533|143228322|NON_INFERIORITY_OR_EQUIVALENCE|The standard bioequivalence range of 80 to 125% was pre-specified for AUC0-6,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|75.99|STANDARD_DEVIATION|34.1||0.8683||90.0|70.44|81.98||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.|||81.98|70.44|0.8683
71857074|NCT01222533|143228323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.014||||95.0|0.06|0.114|||||Tio R1.25-Placebo|||0.114|0.060|
71857075|NCT01222533|143228323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.074|0.128|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.128|0.074|<0.0001
71857076|NCT01222533|143228323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001||95.0|0.094|0.148|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.148|0.094|<0.0001
71857077|NCT01222533|143228324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.012||||95.0|0.141|0.189|||||Tio R1.25-Placebo.|||0.189|0.141|
71857078|NCT01222533|143228324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.161|0.209|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.209|0.161|<0.0001
71857079|NCT01222533|143228324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.167|0.216|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.216|0.167|<0.0001
71857080|NCT01222533|143228325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.013||||95.0|0.13|0.18|||||Tio R1.25-Placebo|||0.180|0.130|
71857081|NCT01222533|143228325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.155|0.205|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.205|0.155|<0.0001
71857082|NCT01222533|143228325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.162|0.211|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.211|0.162|<0.0001
71857083|NCT01222533|143228326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.028||||95.0|0.083|0.194|||||Tio R1.25-Placebo|||0.194|0.083|
71857084|NCT01222533|143228326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.133|0.244|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.244|0.133|<0.0001
71857085|NCT01222533|143228326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.18|0.292|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.292|0.180|<0.0001
71857086|NCT01222533|143228327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.022||||95.0|0.241|0.326|||||Tio R1.25-Placebo|||0.326|0.241|
71857087|NCT01222533|143228327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.319|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.276|0.362|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.362|0.276|<0.0001
71905853|NCT00696436|143333886|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.59|||<|0.001|TWO_SIDED|95.0|-5.72|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.46|-5.72|<0.001
71905854|NCT00696436|143333887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.14|||<|0.001|TWO_SIDED|95.0|-11.92|-8.36||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-8.36|-11.92|<0.001
71905855|NCT00696436|143333887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.17|||<|0.001|TWO_SIDED|95.0|-10.94|-7.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-7.40|-10.94|<0.001
71905856|NCT00696436|143333887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.002|TWO_SIDED|95.0|-3.81|-0.82||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.82|-3.81|0.002
71905857|NCT00696436|143333887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|||<|0.001|TWO_SIDED|95.0|-4.24|-1.19||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.19|-4.24|<0.001
71905858|NCT00696436|143333887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.076|TWO_SIDED|95.0|-2.82|0.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.14|-2.82|0.076
71681157|NCT00772005|142881139|SUPERIORITY_OR_OTHER|||||||0.6173||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6173
71681158|NCT00772005|142881139|SUPERIORITY_OR_OTHER|||||||0.5415||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5415
71905859|NCT00696436|143333887|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.024|TWO_SIDED|95.0|-3.25|-0.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.22|-3.25|0.024
71905860|NCT00696436|143333888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.84|||<|0.001|TWO_SIDED|95.0|-15.66|-10.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-10.02|-15.66|<0.001
71681159|NCT00772005|142881140|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
71857088|NCT01222533|143228327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.292|0.378|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.378|0.292|<0.0001
71857089|NCT01222533|143228328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|STANDARD_ERROR_OF_MEAN|0.023||||95.0|0.236|0.325|||||Tio R1.25-Placebo|||0.325|0.236|
71857090|NCT01222533|143228328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.279|0.369|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo|||0.369|0.279|<0.0001
71857091|NCT01222533|143228328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.339|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.294|0.384|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo|||0.384|0.294|<0.0001
71857092|NCT00526097|143228360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001||95.0|2.6|4.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.0|2.6|<0.0001
71905861|NCT00696436|143333888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.91|||<|0.001|TWO_SIDED|95.0|-14.72|-9.11||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-9.11|-14.72|<0.001
71905862|NCT00696436|143333888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.74||||0.149|TWO_SIDED|95.0|-4.1|0.62||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||0.62|-4.10|0.149
71905863|NCT00696436|143333888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.24|||<|0.001|TWO_SIDED|95.0|-6.65|-1.83||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-1.83|-6.65|<0.001
71905864|NCT00696436|143333888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.494|TWO_SIDED|95.0|-3.16|1.53||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.53|-3.16|0.494
71905865|NCT00696436|143333888|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.32||||0.007|TWO_SIDED|95.0|-5.72|-0.93||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.93|-5.72|0.007
71905866|NCT00696436|143333889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||<|0.001|TWO_SIDED|95.0|-10.03|-5.79||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.79|-10.03|<0.001
71905867|NCT00696436|143333889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.99|||<|0.001|TWO_SIDED|95.0|-10.1|-5.88||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-5.88|-10.10|<0.001
71905868|NCT00696436|143333889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.691|TWO_SIDED|95.0|-2.14|1.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.42|-2.14|0.691
71681160|NCT00772005|142881140|SUPERIORITY_OR_OTHER|||||||0.6642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6642
71857093|NCT00526097|143228361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|0.42|<|0.0001||95.0|3.5|5.2||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.2|3.5|<0.0001
71857094|NCT00526097|143228362|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.7|4.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.3|2.7|<0.0001
71857095|NCT00526097|143228363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.0001||95.0|2.0|3.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.6|2.0|<0.0001
71857096|NCT00526097|143228364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|1.8|3.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.4|1.8|<0.0001
71905869|NCT00696436|143333889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.39||||0.01|TWO_SIDED|95.0|-4.2|-0.57||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.57|-4.20|0.010
71905870|NCT00696436|143333889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.625|TWO_SIDED|95.0|-2.2|1.32||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||1.32|-2.20|0.625
71905871|NCT00696436|143333889|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46||||0.008|TWO_SIDED|95.0|-4.27|-0.66||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA|||||-0.66|-4.27|0.008
71905872|NCT00696436|143333890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.98|||<|0.001|TWO_SIDED|95.0|3.15|7.88||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.88|3.15|<0.001
71905873|NCT00696436|143333890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.66|||<|0.001|TWO_SIDED|95.0|2.94|7.37||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.37|2.94|<0.001
71905874|NCT00696436|143333890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.032|TWO_SIDED|95.0|1.03|2.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.03|1.03|0.032
71905875|NCT00696436|143333890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.029|TWO_SIDED|95.0|1.04|2.06||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.06|1.04|0.029
71905876|NCT00696436|143333890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.89||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.89|0.96|0.080
71905877|NCT00696436|143333890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.071|TWO_SIDED|95.0|0.97|1.92||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.92|0.97|0.071
71905878|NCT00696436|143333891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||<|0.001|TWO_SIDED|95.0|2.1|5.15||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||5.15|2.10|<0.001
71905879|NCT00696436|143333891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.86|4.54||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||4.54|1.86|<0.001
71905880|NCT00696436|143333891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.306|TWO_SIDED|95.0|0.83|1.8||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.80|0.83|0.306
71905881|NCT00696436|143333891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.132|TWO_SIDED|95.0|0.92|1.97||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.97|0.92|0.132
71905882|NCT00696436|143333891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.695|TWO_SIDED|95.0|0.74|1.58||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.58|0.74|0.695
71857097|NCT00526097|143228365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|4.1|5.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.8|4.1|<0.0001
71857098|NCT00526097|143228366|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001||95.0|5.8|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|5.8|<0.0001
71857099|NCT00526097|143228367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001||95.0|3.8|5.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.6|3.8|<0.0001
71857100|NCT00526097|143228368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8|STANDARD_ERROR_OF_MEAN|0.45|<|0.0001||95.0|2.9|4.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.7|2.9|<0.0001
71857101|NCT00526097|143228369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|STANDARD_ERROR_OF_MEAN|0.43|<|0.0001||95.0|2.9|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|2.9|<0.0001
71857102|NCT00526097|143228370|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|||The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.||||<0.0001
71857103|NCT00526097|143228371|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001||95.0|1.62|2.57|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.57|1.62|<0.0001
71857104|NCT00526097|143228372|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|||<|0.0001||95.0|1.44|2.13|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.13|1.44|<0.0001
71857105|NCT00526097|143228373|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08|||<|0.0001||95.0|1.62|2.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.66|1.62|<0.0001
71857106|NCT00526097|143228374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7|||<|0.0001||95.0|1.37|2.11|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.11|1.37|<0.0001
71857107|NCT00526097|143228375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|||<|0.0001||95.0|1.24|1.88|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||1.88|1.24|<0.0001
71857108|NCT00526097|143228376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.13|||<|0.0001||95.0|4.28|68.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||68.66|4.28|<0.0001
71857109|NCT00526097|143228377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46|||<|0.0001||95.0|1.81|3.35|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.35|1.81|<0.0001
71857110|NCT00526097|143228378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.0025||95.0|1.32|4.74|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||4.74|1.32|0.0025
71857111|NCT00526097|143228379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.08||||0.0105||95.0|1.26|13.24|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||13.24|1.26|0.0105
71857112|NCT00526097|143228380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.4002||95.0|0.52|6.47|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||6.47|0.52|0.4002
71857113|NCT00526097|143228381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||1||95.0|0.37|3.77|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||3.77|0.37|1.0000
71857114|NCT00526097|143228382|SUPERIORITY_OR_OTHER|||||||0.0951|||||||Fisher Exact|||||||0.0951
71857115|NCT00526097|143228383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.09|0.41|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.41|0.09|<0.0001
71857116|NCT00526097|143228384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24||||0.2524||95.0|0.02|2.67|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||2.67|0.02|0.2524
71857117|NCT00526097|143228385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2||||0.0035||95.0|0.06|0.63|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.63|0.06|0.0035
71857118|NCT00526097|143228386|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.06||||0.0004||95.0|0.01|0.46|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.46|0.01|0.0004
71857119|NCT00526097|143228387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.27||||0.0086||95.0|0.1|0.69|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented|||0.69|0.10|0.0086
71905883|NCT00696436|143333891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.381|TWO_SIDED|95.0|0.81|1.74||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.74|0.81|0.381
71857120|NCT00526097|143228388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-1.2|-0.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.9|-1.2|<0.0001
71857121|NCT00526097|143228389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.2|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.2|<0.0001
71857122|NCT00526097|143228390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.1|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.8|-1.1|<0.0001
71857123|NCT00526097|143228391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
71857124|NCT00526097|143228392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.4|2.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.9|2.4|<0.0001
71857125|NCT00526097|143228393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|2.1|2.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.7|2.1|<0.0001
71857126|NCT00526097|143228394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|2.0|2.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.5|2.0|<0.0001
71857127|NCT00526097|143228395|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|1.7|2.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.3|1.7|<0.0001
71857128|NCT00526097|143228396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0002||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0002
71857129|NCT00526097|143228397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0003||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0003
71857130|NCT00526097|143228398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0127||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0127
71857131|NCT00526097|143228399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0064||95.0|-0.3|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.3|0.0064
71857132|NCT00526097|143228400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.9|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-0.9|<0.0001
71857133|NCT00526097|143228401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.6|-1.0|<0.0001
71857134|NCT00526097|143228402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.9|<0.0001
71681161|NCT00772005|142881140|SUPERIORITY_OR_OTHER|||||||0.7395||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7395
71681162|NCT00772005|142881141|SUPERIORITY_OR_OTHER|||||||0.8124||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8124
71681163|NCT00772005|142881141|SUPERIORITY_OR_OTHER|||||||0.8961||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8961
71857135|NCT00526097|143228403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
71681164|NCT00772005|142881141|SUPERIORITY_OR_OTHER|||||||0.4999||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4999
71857136|NCT00526097|143228404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
71857137|NCT00526097|143228405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|<0.0001
71857138|NCT00526097|143228406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.2|<0.0001
71857139|NCT00526097|143228407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.0|-0.2|0.0018
71857140|NCT00526097|143228408|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857141|NCT00526097|143228409|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857142|NCT00526097|143228410|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857143|NCT00526097|143228411|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857144|NCT00526097|143228412|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857145|NCT00526097|143228413|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857146|NCT00526097|143228414|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857147|NCT00526097|143228415|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857148|NCT00526097|143228416|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857149|NCT00526097|143228417|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857150|NCT00526097|143228418|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857151|NCT00526097|143228419|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||<0.0001
71857152|NCT00526097|143228420|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.6773
71857153|NCT00526097|143228421|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0002
71857154|NCT00526097|143228422|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0001
71857155|NCT00526097|143228423|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline||||||0.0005
71857156|NCT00526097|143228424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
71857157|NCT00526097|143228425|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
71857158|NCT00526097|143228426|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test|||||||<0.0001
71857159|NCT00526097|143228427|SUPERIORITY_OR_OTHER|||||||0.0058||||||Exact p-value|Wilcoxon rank sum test|||||||0.0058
71857160|NCT00526097|143228428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|2.01||0.798||95.0|-3.4|4.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.5|-3.4|0.7980
71857161|NCT00526097|143228429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|2.05||0.6129||95.0|-3.0|5.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.1|-3.0|0.6129
71857162|NCT00526097|143228430|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.31||0.3567||95.0|-2.4|6.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.7|-2.4|0.3567
71857163|NCT00526097|143228431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|1.34||0.1407||95.0|-0.7|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.6|-0.7|0.1407
71857164|NCT00526097|143228432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.3|STANDARD_ERROR_OF_MEAN|1.74||0.013||95.0|0.9|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||7.7|0.9|0.0130
71857165|NCT00526097|143228433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|2.14||0.5849||95.0|-3.0|5.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||5.3|-3.0|0.5849
71857166|NCT00526097|143228434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.94||0.7543||95.0|-3.2|4.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||4.4|-3.2|0.7543
71857167|NCT00526097|143228435|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.58||0.0273||95.0|0.4|6.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||6.6|0.4|0.0273
71857168|NCT00526097|143228436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.87||0.129||95.0|-0.4|3.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||3.0|-0.4|0.1290
71857169|NCT00526097|143228437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.378||95.0|-0.8|2.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||2.0|-0.8|0.3780
71857170|NCT00526097|143228438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.6|-0.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.3|-0.6|<0.0001
71857171|NCT00526097|143228439|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-1.0|-0.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.7|-1.0|<0.0001
71857172|NCT00526097|143228440|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.007||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.1|-0.3|0.0070
71857173|NCT00526097|143228441|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.5|-1.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-1.0|-1.5|<0.0001
71857174|NCT00526097|143228442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate||-0.5|-0.8|<0.0001
71857175|NCT00460564|143228446|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.83|||<|0.001||95.0|-10.567|-3.093|||t-test, 2 sided|||||-3.093|-10.567|<0.001
71857176|NCT02412111|143228489|SUPERIORITY||Least Square (LS) mean difference|0.3|||=|0.5846|TWO_SIDED|95.0|-0.8|1.4|||Mixed Model for Repeated Measures (MMRM)|||||1.4|-0.8|= 0.5846
71857177|NCT02412111|143228490|SUPERIORITY||Least square mean difference|0.8|||=|0.386|TWO_SIDED|95.0|-1.0|2.6|||Mixed models Repeated Measures (MMRM)|||||2.6|-1.0|= 0.3860
71857178|NCT02412111|143228491|SUPERIORITY||Least square mean difference|2.8|||=|0.1236|TWO_SIDED|95.0|-0.8|6.4|||Mixed models Repeated Measures (MMRM)|||||6.4|-0.8|= 0.1236
71857179|NCT02412111|143228492|SUPERIORITY||Least square mean difference|-5.8|||=|0.0216|TWO_SIDED|95.0|-10.7|-0.9|||Mixed models Repeated Measures (MMRM)|||||-0.9|-10.7|= 0.0216
71857180|NCT04349644|143228507|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent vari- ables.||||||0.016|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.016
71857181|NCT04349644|143228507|OTHER|"A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each depen- dent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate.~Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables."||||||0.288|||||||ANCOVA|Follow-up ANCOVA while controlling Pretest.||||||0.288
71857182|NCT04349644|143228508|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.932|||||||ANCOVA|Posttest ANCOVA controlling pretest value for CASS Vocal Expressiveness.||||||0.932
71857183|NCT04349644|143228508|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.221|||||||ANCOVA|Posttest ANCOVA controlling for pretest for CASS Quality of Rapport.||||||0.221
71857184|NCT04349644|143228508|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.873|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Vocal Expressiveness.||||||0.873
71857185|NCT04349644|143228508|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.512|||||||ANCOVA|Follow-up ANCOVA controlling for pretest Quality of Rapport.||||||0.512
71857186|NCT04349644|143228509|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.05|||||||ANCOVA|Posttest ANCOVA controlling for Pretest.||||||0.05
71857187|NCT04349644|143228509|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables.||||||0.393|||||||ANCOVA|Follow-up ANCOVA controlling for Pretest.||||||0.393
71857188|NCT04349644|143228510|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.917|||||||ANCOVA|Posttest ANCOVA controlling for pretest values.||||||0.917
71905884|NCT00696436|143333892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.18|||<|0.001|TWO_SIDED|95.0|3.2|8.41||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||8.41|3.20|<0.001
71905885|NCT00696436|143333892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.43|||<|0.001|TWO_SIDED|95.0|2.73|7.19||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||7.19|2.73|<0.001
71905886|NCT00696436|143333892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.056|TWO_SIDED|95.0|0.99|1.94||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.94|0.99|0.056
71905887|NCT00696436|143333892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.036|TWO_SIDED|95.0|1.02|2.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||2.02|1.02|0.036
71905888|NCT00696436|143333892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.317|TWO_SIDED|95.0|0.85|1.66||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.66|0.85|0.317
71905889|NCT00696436|143333892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.234|TWO_SIDED|95.0|0.87|1.73||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic|||||1.73|0.87|0.234
71905890|NCT02062463|143333905|OTHER||Odds Ratio (OR)|3.77|||<|0.001|TWO_SIDED|95.0|2.05|6.95||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||6.95|2.05|<0.001
71905891|NCT02062463|143333906|OTHER||Odds Ratio (OR)|1.26||||0.316|TWO_SIDED|95.0|0.8|1.98||Threshold for significance at 0.05 level.|Chi-squared|||Analysis was performed using a conditional logistic regression model.||1.98|0.80|0.316
71905892|NCT03341923|143333927|NON_INFERIORITY|"Difference (DT1MF-AMMF) of percentage of subjects rated as Optimal was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated."|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
71905893|NCT03341923|143333927|SUPERIORITY|After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|TWO_SIDED|95.0|0.2|11.9|||McNemar|||||11.9|0.2|0.0455
71905894|NCT02662985|143333937|SUPERIORITY||Median Difference (Net)|-3.18|STANDARD_ERROR_OF_MEAN|1.18||0.004|TWO_SIDED|95.0|-5.52|-0.85|||Mixed Models Analysis|mixed model repeated measures (MMRM)||GLOESS scores||-0.85|-5.52|0.0040
71905895|NCT02662985|143333938|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.0001|TWO_SIDED|95.0|2.38|8.89|||Regression, Logistic|Logistic regression using non-responder imputation||Proportion of patients with ACR 20 response at Week 12 (FAS)||8.89|2.38|<0.0001
71905896|NCT02662985|143333939|SUPERIORITY||Odds Ratio (OR)|9.65|||<|0.0001|TWO_SIDED|95.0|3.92|23.75|||Regression, Logistic|||Proportion of patients with ACR 50 response at Week 12 (FAS)||23.75|3.92|<0.0001
71905897|NCT02662985|143333940|SUPERIORITY||Adjusted mean of treatment difference|-0.67|STANDARD_ERROR_OF_MEAN|0.36||0.0327|TWO_SIDED|95.0|-1.374|0.043|||Regression, Logistic|||SPARCC||0.043|-1.374|0.0327
71905898|NCT03491553|143333944|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905899|NCT03491553|143333944|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905900|NCT03491553|143333944|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905901|NCT03491553|143333944|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
71905902|NCT03491553|143333945|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905903|NCT03491553|143333945|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905904|NCT03491553|143333945|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905905|NCT03491553|143333945|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905906|NCT03491553|143333946|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905907|NCT03491553|143333946|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905908|NCT03491553|143333946|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905909|NCT03491553|143333946|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905910|NCT03491553|143333947|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905911|NCT03491553|143333947|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905912|NCT03491553|143333947|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905913|NCT03491553|143333947|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905914|NCT03491553|143333948|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905915|NCT03491553|143333948|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905916|NCT03491553|143333948|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0||||||||||||
71905917|NCT03491553|143333948|OTHER||Percentage Difference|10.0|||||TWO_SIDED|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.|||47.1|-47.2|
71905918|NCT00973921|143333974|SUPERIORITY_OR_OTHER||Proportion|1.0|||<|0.01|TWO_SIDED|95.0|0.86|1.0|||Wilson|||The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportion||1.0|0.86|<0.01
71905919|NCT00973921|143333975|SUPERIORITY_OR_OTHER||Correlation coefficient|0.74|||<|0.0001|||||||Bland Altman|||||||<0.0001
71905920|NCT00973921|143333977|SUPERIORITY_OR_OTHER||Correlation coefficient|0.5||||0.0034|||||||Bland-Altman|||||||0.0034
71905921|NCT01599754|143333978|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.3211|TWO_SIDED|95.0|0.66|1.147|||Log Rank|||||1.147|0.660|0.3211
71905922|NCT01599754|143333979|SUPERIORITY||Hazard Ratio (HR)|1.026||||0.9246|TWO_SIDED|95.0|0.6|1.756|||Log Rank|||||1.756|0.600|0.9246
71905923|NCT01551758|143333987|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.92|||=|0.025|TWO_SIDED|95.0|0.85|0.99|||Generalized Linear Model|||||0.99|0.85|=0.025
71857189|NCT04349644|143228510|OTHER|A series of Analysis of Covariance (ANCOVA) models were used to test the between-group differences on each dependent variable at the immediate posttest and at the follow-up periods separately using the pretest values as a covariate. Independent samples t-tests were used to identify statistically significant differences on all pretest dependent variables||||||0.963|||||||ANCOVA|Follow-up ANCOVA while controlling for pretest.||||||0.963
71857190|NCT01114139|143228522|SUPERIORITY|The 95% confidence interval was calculated using the large sample assumption.|Treatment Difference|75.59|||<|0.0001|TWO_SIDED|95.0|71.15|80.02|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - placebo) was expressed as a percentage.|Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.||80.02|71.15|<0.0001
71905924|NCT01551758|143333988|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.1|||||TWO_SIDED|95.0|0.9|1.5|||||Calculated as % of participants who had at least one SAE of pneumonia in the FF/VI group divided by the % of participants who had at least one SAE of pneumonia in the Usual Care group|||1.5|0.9|
71857191|NCT02705625|143228531|SUPERIORITY|"For the primary endpoint, the Type I error for the tests of the two doses was protected by performing a fixed-sequence multiple-testing procedure in the following order:~Step 1: 200 mg versus placebo Step 2: 100 mg versus placebo The second step was only considered as confirmatory provided the previous step was significant at a one-sided 5%-level (p\<0.05).~If the previous step was not significant, the analysis of the following step was considered descriptive."|Mean Difference (Final Values)|-0.0761||||0.4055|TWO_SIDED|95.0|-0.703|0.55||The p-values reported is from Step 1 (comparing 200 mg versus placebo). The corresponding p-value from Step 2 (comparing 100 mg versus placebo) was 0.1458.|Mixed Models Analysis|||A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment by time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline NRS was included as a covariate for adjustment. An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model.||0.55|-0.703|0.4055
71857192|NCT02705625|143228532|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-14.7||||0.0036|TWO_SIDED|95.0|-25.3|-4.02||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.02|-25.3|0.0036
71857193|NCT02705625|143228532|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-15.4||||0.0023|TWO_SIDED|95.0|-26.0|-4.83||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-4.83|-26|0.0023
71857194|NCT02705625|143228533|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0436||||0.1253|TWO_SIDED|95.0|-0.031|0.118||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.118|-0.031|0.1253
71857195|NCT02705625|143228533|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0761||||0.0225|TWO_SIDED|95.0|0.00173|0.15||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||0.15|0.00173|0.0225
71905925|NCT01551758|143333989|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.08||||0.632|TWO_SIDED|95.0|0.79|1.47|||Generalized linear model|||||1.47|0.79|0.632
71905926|NCT01551758|143333990|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||=|0.439|TWO_SIDED|95.0|0.83|1.52|||Cox proportional hazards model|||||1.52|0.83|=0.439
71905927|NCT01551758|143333991|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.06||||0.488|TWO_SIDED|95.0|0.89|1.27|||Generalized linear model|||||1.27|0.89|0.488
71905928|NCT01551758|143333992|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|0.98||||0.622|TWO_SIDED|95.0|0.92|1.05|||Generalized linear model|||||1.05|0.92|0.622
71681165|NCT00772005|142881151|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4540
71681166|NCT00772005|142881151|SUPERIORITY_OR_OTHER|||||||0.358||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3580
71905929|NCT01551758|143333993|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.05||||0.336|TWO_SIDED|95.0|0.95|1.15|||Generalized Linear Model|||||1.15|0.95|0.336
71905930|NCT01551758|143333994|SUPERIORITY_OR_OTHER||Adjusted treatment ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.05|1.2|||Generalized Linear Model|||||1.20|1.05|<0.001
71905931|NCT01551758|143333995|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89|||<|0.001|TWO_SIDED|95.0|1.6|2.23|||Cox proportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care.|||2.23|1.60|<0.001
71905932|NCT01551758|143333996|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.37|0.66|||Cox proprotional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||0.66|0.37|<0.001
71681167|NCT00772005|142881151|SUPERIORITY_OR_OTHER|||||||0.6271||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6271
71681168|NCT00772005|142881152|SUPERIORITY_OR_OTHER|||||||0.1459||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1459
71857196|NCT02705625|143228534|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-1.77||||0.2887|TWO_SIDED|95.0|-8.02|4.48||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time,baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.48|-8.02|0.2887
71857197|NCT02705625|143228534|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-4.55||||0.0753|TWO_SIDED|95.0|-10.8|1.67||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||1.67|-10.8|0.0753
71857198|NCT02705625|143228535|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-1.84||||0.2898|TWO_SIDED|95.0|-8.38|4.7||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.7|-8.38|0.2898
71857199|NCT02705625|143228535|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-3.78||||0.1262|TWO_SIDED|95.0|-10.3|2.72||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.72|-10.3|0.1262
71857200|NCT02705625|143228536|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-3.07||||0.2|TWO_SIDED|95.0|-10.2|4.1||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||4.1|-10.2|0.2
71905933|NCT01551758|143333997|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.111|TWO_SIDED|95.0|0.85|1.02|||Cox porportional hazards model||A hazard ratio \<1 indicates a lower risk with FF/VI compared with Usual Care|||1.02|0.85|0.111
71905934|NCT01551758|143333998|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.081|TWO_SIDED|95.0|0.84|1.01|||Cox porportional hazards model|||||1.01|0.84|0.081
71905935|NCT01551758|143333999|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.075|TWO_SIDED|95.0|0.98|1.66|||Cox proportional hazards model|||||1.66|0.98|0.075
71905936|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Neoplasm||||0.881
71905937|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Tobacco use||||0.517
71905938|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||BMI(kg/mˆ2)\>30||||0.053
71905939|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Diabetes mellitus||||0.289
71905940|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Immunosuppression/Corticosteroids||||1.000
71905941|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Anemia (Hb\<9gr/dL)||||0.169
71905942|NCT00906074|143334006|SUPERIORITY_OR_OTHER|||||||0.637|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||Malnutrition (hypoalbuminemia)||||0.637
71905943|NCT00906074|143334007|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||1.000
71905944|NCT00906074|143334008|SUPERIORITY_OR_OTHER|||||||0.873|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.873
71905945|NCT00906074|143334013|SUPERIORITY_OR_OTHER|||||||0.156|TWO_SIDED||||||Chi-squared|Chi-squared Pearson||||||0.156
71905946|NCT00906074|143334014|SUPERIORITY_OR_OTHER|||||||0.444|TWO_SIDED||||||Fisher Exact|||||||0.444
71905947|NCT00753935|143334044|SUPERIORITY|||||||0.005|||||||Wilcoxon rank-sum|||||||0.005
71905948|NCT02128763|143334045|SUPERIORITY|||||||0.4|TWO_SIDED|95.0||||P value refers to difference between group on change in overall OSDI score (Row 1).|Regression, Linear|||||||0.40
71905949|NCT02128763|143334046|SUPERIORITY|||||||0.09|TWO_SIDED|95.0|||||Regression, Linear|||||||0.09
71905950|NCT02128763|143334047|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|Pos hoc application of the Benjamini-Hochberg adjustment||||||0.77
71905951|NCT02128763|143334048|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
71905952|NCT02128763|143334049|SUPERIORITY|||||||0.051|TWO_SIDED|95.0|||||Regression, Linear|||||||0.051
71905953|NCT02128763|143334050|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
71905954|NCT02128763|143334051|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0|||||Regression, Linear|||||||<0.001
71905955|NCT02128763|143334052|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||Regression, Linear|||||||0.40
71905956|NCT02128763|143334053|SUPERIORITY|||||||0.77|TWO_SIDED|95.0|||||Regression, Linear|||||||0.77
71857201|NCT02705625|143228536|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-4.95||||0.0861|TWO_SIDED|95.0|-12.1|2.17||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||2.17|-12.1|0.0861
71857202|NCT02705625|143228537|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.254|||<|0.0001|TWO_SIDED|95.0|-0.302|-0.206||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.206|-0.302|<0.0001
71905957|NCT02128763|143334054|SUPERIORITY|||||||0.95|TWO_SIDED|95.0|||||Regression, Linear|||||||0.95
71905958|NCT02128763|143334055|SUPERIORITY|||||||0.25|TWO_SIDED|95.0|||||Regression, Linear|||||||0.25
71905959|NCT02128763|143334056|SUPERIORITY|||||||0.61|TWO_SIDED|95.0|||||Regression, Linear|||||||0.61
71905960|NCT02128763|143334057|SUPERIORITY|||||||0.42|TWO_SIDED|95.0|||||Regression, Linear|||||||0.42
71905961|NCT02128763|143334058|SUPERIORITY|||||||0.6|TWO_SIDED|95.0|||||Chi-squared, Corrected|||||||0.60
71905962|NCT02128763|143334059|SUPERIORITY|||||||0.17|TWO_SIDED|95.0|||||Regression, Linear|||||||0.17
71905963|NCT02128763|143334060|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
71905964|NCT02128763|143334061|SUPERIORITY|||||||0.71|TWO_SIDED|95.0|||||Regression, Linear|||||||0.71
71905965|NCT02128763|143334062|SUPERIORITY|||||||0.66|TWO_SIDED|95.0|||||Regression, Linear|||||||0.66
71905966|NCT02128763|143334063|SUPERIORITY|||||||0.02|TWO_SIDED|95.0|||||Regression, Linear|||||||0.02
71905967|NCT03282357|143334065|NON_INFERIORITY|Non-inferiority margin, delta = 10 percent (%). The two-sided 95% confidence interval (CI) for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-6.8|||||TWO_SIDED|95.0|-13.1|-0.5||||||||-0.5|-13.1|
71905968|NCT03282357|143334066|NON_INFERIORITY|Non-inferiority margin, delta = 15%. The two-sided 95% CI for the differences between percentages was constructed using the Newcombe's recommended method.|Difference in Percentage|-4.9|||||TWO_SIDED|95.0|-9.8|-0.3||||||||-0.3|-9.8|
71905969|NCT01586156|143334067|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
71905970|NCT01586156|143334068|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
71905971|NCT01586156|143334069|OTHER|Pearson's correlation test of association of alprenolol binding changes to dose carvedilol.||||||0.02||||||Correlation of the change in alprenolol binding relative to dose carvedilol.|Pearson|||||||0.02
71905972|NCT01586156|143334070|SUPERIORITY|||||||0.05|||||||ANOVA|||||||0.05
71905973|NCT01586156|143334072|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71905974|NCT01586156|143334073|NON_INFERIORITY|Carvedilol did not lead to worse cardiac output as compared to placebo.||||||0.8|||||||ANOVA|||||||0.8
71905975|NCT00975195|143334074|NON_INFERIORITY_OR_EQUIVALENCE|Upper limit of 95% confidence interval (CI) \<1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance|Hazard Ratio (HR)|1.058||||0.3497|TWO_SIDED|95.0|0.941|1.189||Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.|Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.189|0.941|0.3497
71905976|NCT00975195|143334075|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4441|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4441
71905977|NCT00975195|143334076|SUPERIORITY_OR_OTHER|||||||0.2269|TWO_SIDED||||||Fisher Exact|||||||0.2269
71905978|NCT00975195|143334077|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.202||||0.0849|TWO_SIDED|95.0|0.975|1.481|||Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.481|0.975|0.0849
71905979|NCT00975195|143334078|SUPERIORITY_OR_OTHER||Rate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.13||0.2291|TWO_SIDED|95.0|0.92|1.45|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.45|0.92|0.2291
71905980|NCT00975195|143334079|SUPERIORITY_OR_OTHER|||||||0.2083|TWO_SIDED||||||Fisher Exact|||||||0.2083
71905981|NCT00975195|143334080|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.5562|TWO_SIDED|95.0|0.923|1.16|||Chi-squared|||||1.160|0.923|0.5562
71857203|NCT02705625|143228537|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.145|||<|0.0001|TWO_SIDED|95.0|-0.193|-0.0983||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-0.0983|-0.193|<0.0001
71905982|NCT00975195|143334081|SUPERIORITY_OR_OTHER||Rate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.06||0.4342|TWO_SIDED|95.0|0.93|1.18|||Regression, Negative binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance|||1.18|0.93|0.4342
71905983|NCT00975195|143334082|SUPERIORITY_OR_OTHER|||||||0.3155|TWO_SIDED||||||Fisher Exact|||||||0.3155
71905984|NCT00975195|143334084|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.0134||0.0014|TWO_SIDED|95.0|-0.069|-0.017|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.017|-0.069|0.0014
71905985|NCT00975195|143334085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.064|STANDARD_ERROR_OF_MEAN|0.034||0.0632|TWO_SIDED|95.0|-0.004|0.131|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.131|-0.004|0.0632
71905986|NCT00975195|143334086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.055||0.8137|TWO_SIDED|95.0|-0.122|0.096|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.096|-0.122|0.8137
71905987|NCT00975195|143334087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.53|STANDARD_ERROR_OF_MEAN|3.17||0.2663|TWO_SIDED|95.0|-9.74|2.69|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.69|-9.74|0.2663
71905988|NCT00975195|143334088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.06||0.0033|TWO_SIDED|95.0|0.05|0.27|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.27|0.05|0.0033
71905989|NCT00975195|143334089|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03|STANDARD_ERROR_OF_MEAN|1.499||0.4914|TWO_SIDED|95.0|-3.98|1.91|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.91|-3.98|0.4914
71905990|NCT00975195|143334090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56|STANDARD_ERROR_OF_MEAN|1.669||0.349|TWO_SIDED|95.0|-4.84|1.71|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||1.71|-4.84|0.3490
71905991|NCT00975195|143334091|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|1.48||0.9262|TWO_SIDED|95.0|-2.77|3.04|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||3.04|-2.77|0.9262
71905992|NCT00975195|143334092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.64|STANDARD_ERROR_OF_MEAN|1.716||0.1241|TWO_SIDED|95.0|-0.73|6.01|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||6.01|-0.73|0.1241
71905993|NCT00975195|143334093|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.0123|<|0.0001|TWO_SIDED|95.0|-0.073|-0.024|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.024|-0.073|<0.0001
71905994|NCT00975195|143334094|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0255||0.0855|TWO_SIDED|95.0|-0.094|0.006|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||0.006|-0.094|0.0855
71905995|NCT00975195|143334095|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.161|STANDARD_ERROR_OF_MEAN|0.045||0.0004|TWO_SIDED|95.0|-0.249|-0.073|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.073|-0.249|0.0004
71905996|NCT00975195|143334096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.728||0.1838|TWO_SIDED|95.0|-0.46|2.4|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.40|-0.46|0.1838
71905997|NCT00975195|143334097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35|STANDARD_ERROR_OF_MEAN|0.702||0.0551|TWO_SIDED|95.0|-0.03|2.72|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.72|-0.03|0.0551
71905998|NCT00975195|143334098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.845||0.4804|TWO_SIDED|95.0|-1.06|2.25|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.25|-1.06|0.4804
71905999|NCT00975195|143334099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.22|STANDARD_ERROR_OF_MEAN|0.614||0.0467|TWO_SIDED|95.0|0.02|2.43|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||2.43|0.02|0.0467
71906000|NCT00975195|143334100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0223|TWO_SIDED|95.0|-0.21|-0.02|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit||-0.02|-0.21|0.0223
71906001|NCT04501679|143334103|SUPERIORITY||Strata-adjusted percentage difference|37.4|||<|0.0001|TWO_SIDED|95.0|26.3|48.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||48.5|26.3|<0.0001
71906002|NCT04501679|143334104|SUPERIORITY||Strata-adjusted percentage difference|28.5|||<|0.0001|TWO_SIDED|95.0|18.8|38.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.2|18.8|<0.0001
71906003|NCT04501679|143334105|SUPERIORITY||Strata-adjusted percentage difference|33.4|||<|0.0001|TWO_SIDED|95.0|24.3|42.4||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||42.4|24.3|<0.0001
71906004|NCT04501679|143334106|SUPERIORITY||Strata-adjusted percentage difference|30.0|||<|0.0001|TWO_SIDED|95.0|21.3|38.6||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||38.6|21.3|<0.0001
71681169|NCT00772005|142881152|SUPERIORITY_OR_OTHER|||||||0.6004||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6004
71681170|NCT00772005|142881152|SUPERIORITY_OR_OTHER|||||||0.0192||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0192
71681171|NCT00772005|142881153|SUPERIORITY_OR_OTHER|||||||0.8455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8455
71681172|NCT00772005|142881153|SUPERIORITY_OR_OTHER|||||||0.8715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8715
71681173|NCT00772005|142881153|SUPERIORITY_OR_OTHER|||||||0.0309||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0309
71681174|NCT00772005|142881154|SUPERIORITY_OR_OTHER|||||||0.2664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2664
71681175|NCT00772005|142881154|SUPERIORITY_OR_OTHER|||||||0.3528||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3528
71681176|NCT00772005|142881154|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0380
71857204|NCT02705625|143228538|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-270.0|||<|0.0001|TWO_SIDED|95.0|-339.0|-201.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-201|-339|<0.0001
71857205|NCT02705625|143228538|SUPERIORITY|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-193.0|||<|0.0001|TWO_SIDED|95.0|-262.0|-124.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by- time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."||-124|-262|<0.0001
71681177|NCT00772005|142881155|SUPERIORITY_OR_OTHER|||||||0.3316||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3316
71681178|NCT00772005|142881155|SUPERIORITY_OR_OTHER|||||||0.349||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3490
71681179|NCT00772005|142881155|SUPERIORITY_OR_OTHER|||||||0.0926||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0926
71681180|NCT00772005|142881156|SUPERIORITY_OR_OTHER|||||||0.8835||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8835
71681181|NCT00772005|142881156|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
71681182|NCT00772005|142881156|SUPERIORITY_OR_OTHER|||||||0.0883||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0883
71681183|NCT00772005|142881157|SUPERIORITY_OR_OTHER|||||||0.6948||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6948
71681184|NCT00772005|142881157|SUPERIORITY_OR_OTHER|||||||0.3345||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3345
71857206|NCT02287883|143228554|OTHER|Clustered two-sample t-test||||||0.8|||||||t-test, 2 sided|||||||0.80
71857207|NCT02287883|143228555|OTHER|Clustered two-sample t-test||||||0.48|||||||t-test, 2 sided|||||||0.48
71857208|NCT02287883|143228556|OTHER|Clustered two-sample t-test||||||0.05|||||||t-test, 2 sided|||||||0.05
71857209|NCT00802438|143228557|OTHER||||||<|0.0001||||||A two-sided p-value\<0.05 was considered significant. Analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC.).|t-test, 2 sided|||Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||<0.0001
71857210|NCT00802438|143228558|OTHER|Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||||0.01|||||||t-test, 2 sided|||||||0.01
71906005|NCT04501679|143334107|SUPERIORITY||Strata-adjusted percentage difference|31.9|||<|0.0001|TWO_SIDED|95.0|20.7|43.2||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel|CMH test using the randomized stratification variables (analysis center and body weight at randomization \[\<90 kg,\>=90 kg\]).|Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||43.2|20.7|<0.0001
71906006|NCT04501679|143334108|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.|Strata-adjusted percentage difference|27.9|||<|0.0001|TWO_SIDED|95.0|18.4|37.5||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|||37.5|18.4|<0.0001
71906007|NCT04501679|143334109|SUPERIORITY||Strata-adjusted percentage difference|18.8|||<|0.0001|TWO_SIDED|95.0|12.0|25.7||A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization \[\< 90 kg, \>= 90 kg\]). Threshold of significance at 0.05.|Cochran-Mantel-Haenszel||Strata adjusted percentage difference was obtained using weighted average of stratum-specific percentage using CMH.|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.||25.7|12.0|<0.0001
71906008|NCT02121756|143334146|OTHER|The sCD14 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD14||||||0.822|||||||Regression, Linear|||||||0.8220
71906009|NCT02121756|143334147|OTHER|The sCD163 is measured in ng/ml and the median change is shown in ng/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD163.||||||0.0869|||||||Regression, Linear|||||||0.0869
71906010|NCT02121756|143334148|OTHER|The IL-6 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma IL-6.||||||0.5027|||||||Regression, Linear|||||||0.5027
71906011|NCT02121756|143334149|OTHER|||||||0.4548|||||||Mixed Models Analysis|||||||0.4548
71906012|NCT02121756|143334151|OTHER|||||||0.7556|||||||Mixed Models Analysis|||||||0.7556
71906013|NCT02121756|143334152|OTHER|||||||0.2075|||||||Mixed Models Analysis|||||||0.2075
71906014|NCT02121756|143334153|OTHER|||||||0.0315|||||||Mixed Models Analysis|||||||0.0315
71906015|NCT02121756|143334154|OTHER|||||||0.7376|||||||Mixed Models Analysis|||||||0.7376
71857211|NCT02341599|143228652|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.29|||||TWO_SIDED|90.0|1.06|1.58|||||LS mean ratio was calculated from analysis of variance (ANOVA) model.|||1.58|1.06|
71857212|NCT02341599|143228652|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|1.08|||||TWO_SIDED|90.0|0.889|1.32|||||LS mean ratio was calculated from ANOVA model.|||1.32|0.889|
71857213|NCT02341599|143228652|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|2.51|||||TWO_SIDED|90.0|2.06|3.06|||||LS mean ratio was calculated from ANOVA model.|||3.06|2.06|
71857214|NCT02341599|143228652|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.989|||||TWO_SIDED|90.0|0.806|1.21|||||LS mean ratio was calculated from ANOVA model.|||1.21|0.806|
71906016|NCT02121756|143334155|OTHER|||||||0.2343|||||||Mixed Models Analysis|||||||0.2343
71906017|NCT02121756|143334156|OTHER|||||||0.7598|||||||Mixed Models Analysis|||||||0.7598
71906018|NCT02121756|143334157|OTHER|||||||0.983|||||||Mixed Models Analysis|||||||0.9830
71906019|NCT02121756|143334158|OTHER|||||||0.3317|||||||Mixed Models Analysis|||||||0.3317
71906020|NCT02121756|143334159|OTHER|||||||0.6121|||||||Mixed Models Analysis|||||||0.6121
71906021|NCT02121756|143334160|OTHER|||||||0.562|||||||Mixed Models Analysis|||||||0.5620
71906022|NCT02365584|143334165|SUPERIORITY|"The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows:~* The equality of variances was to verified using the Levene's test. If it was significant AUC values were to be properly transformed.~* The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis.~* The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests."|Adjusted LS Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|17.7|=|0.5396|TWO_SIDED|95.0|-47.0|25.0|||ANCOVA|||Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.||25|-47|=0.5396
71857215|NCT02341599|143228652|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|3.27|||||TWO_SIDED|90.0|2.67|4.02|||||LS mean ratio was calculated from ANOVA model.|||4.02|2.67|
71906023|NCT02193815|143334192|SUPERIORITY_OR_OTHER||Adjusted Mean Ratio|93.2|STANDARD_ERROR_OF_MEAN|0.075||0.3465|TWO_SIDED|95.0|80.43|107.99|||Mixed Models Analysis|||||107.99|80.43|0.3465
71857216|NCT02341599|143228652|OTHER|LS mean ratio of Group E: Period 1/Group E: Period 2|LS mean ratio|0.299|||||TWO_SIDED|90.0|0.236|0.378|||||LS mean ratio was calculated from ANOVA model.|||0.378|0.236|
71857217|NCT02341599|143228653|OTHER|LS mean ratio of Group B/Group A|LS mean ratio|1.04|||||TWO_SIDED|90.0|0.846|1.27|||||LS mean ratio was calculated from ANOVA model.|||1.27|0.846|
71857218|NCT02341599|143228653|OTHER|LS mean ratio of Group C/Group A|LS mean ratio|0.524|||||TWO_SIDED|90.0|0.428|0.641|||||LS mean ratio was calculated from ANOVA model.|||0.641|0.428|
71857219|NCT02341599|143228653|OTHER|LS mean ratio of Group D/Group A|LS mean ratio|0.678|||||TWO_SIDED|90.0|0.554|0.831|||||LS mean ratio was calculated from ANOVA model.|||0.831|0.554|
71857220|NCT02341599|143228653|OTHER|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.273|||||TWO_SIDED|90.0|0.221|0.336|||||LS mean ratio was calculated from ANOVA model.|||0.336|0.221|
71857221|NCT02341599|143228653|OTHER|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|0.326|||||TWO_SIDED|90.0|0.265|0.402|||||LS mean ratio was calculated from ANOVA model.|||0.402|0.265|
71857222|NCT02341599|143228653|OTHER|LS mean ratio of Group E: Period 2/Group E: Period 1|LS mean ratio|0.808|||||TWO_SIDED|90.0|0.65|1.0|||||LS mean ratio was calculated from ANOVA model.|||1.00|0.650|
71857223|NCT01355471|143228740|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||GEE: Logit link function|Generalized Estimation Equation (GEE) methods with Logit link function and marginal expectation model.||||||<0.001
71857224|NCT00424177|143228756|SUPERIORITY_OR_OTHER||Proportion of subjects in Cycle 2 or 3|0.87||||||95.0|0.74|0.94||||||||0.94|0.74|
71906024|NCT02193815|143334193|SUPERIORITY_OR_OTHER||Adjusted Mean|165.88|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|143.12|192.25|||Mixed Models Analysis|||||192.25|143.12|<0.0001
71906025|NCT02193815|143334194|SUPERIORITY_OR_OTHER||Adjusted Mean|65.42|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|56.46|75.81|||Mixed Models Analysis|||||75.81|56.46|<0.0001
71906026|NCT02193815|143334195|SUPERIORITY_OR_OTHER||Adjusted Mean|93.04|STANDARD_ERROR_OF_MEAN|0.075||0.3349|TWO_SIDED|95.0|80.3|107.81|||Mixed Models Analysis|||||107.81|80.30|0.3349
71906027|NCT02193815|143334195|SUPERIORITY_OR_OTHER||Adjusted Mean|149.56|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|129.04|173.34|||Mixed Models Analysis|||||173.34|129.04|<0.0001
71906028|NCT02193815|143334195|SUPERIORITY_OR_OTHER||Adjusted Mean|106.51|STANDARD_ERROR_OF_MEAN|0.075||0.3991|TWO_SIDED|95.0|91.92|123.41|||Mixed Models Analysis|||||123.41|91.92|0.3991
71906029|NCT02193815|143334195|SUPERIORITY_OR_OTHER||Adjusted Mean|71.94|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|62.08|83.36|||Mixed Models Analysis|||||83.36|62.08|<0.0001
71906030|NCT02193815|143334196|SUPERIORITY_OR_OTHER||Adjusted Mean|96.04|STANDARD_ERROR_OF_MEAN|0.127||0.7529|TWO_SIDED|95.0|74.0|124.64|||Mixed Models Analysis|||||124.64|74.00|0.7529
71906031|NCT02193815|143334196|SUPERIORITY_OR_OTHER||Adjusted Mean|125.62|STANDARD_ERROR_OF_MEAN|0.147||0.1318|TWO_SIDED|95.0|92.96|169.75|||Mixed Models Analysis|||||169.75|92.96|0.1318
71906032|NCT02193815|143334196|SUPERIORITY_OR_OTHER||Adjusted Mean|103.35|STANDARD_ERROR_OF_MEAN|0.129||0.8009|TWO_SIDED|95.0|79.3|134.68|||Mixed Models Analysis|||||134.68|79.30|0.8009
71906033|NCT02193815|143334196|SUPERIORITY_OR_OTHER||Adjusted Mean|81.09|STANDARD_ERROR_OF_MEAN|0.124||0.1012|TWO_SIDED|95.0|62.94|104.47|||Mixed Models Analysis|||||104.47|62.94|0.1012
71906034|NCT00064350|143334201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0|||||Fisher Exact|||Compare the proportion of patients maintaining stable disease or objective response at 2 months after randomization between the two arms.||||0.005
71906035|NCT00064350|143334202|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Log Rank|||Compare PFS between the Sorafenib arm and the placebo arm||||0.014
71906036|NCT00064350|143334203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||95.0|||||Log Rank|||Compare OS between the Sorafenib arm and the placebo arm||||0.12
71906037|NCT00838916|143334205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11|||||TWO_SIDED|95.0|-0.04|0.27|||ANCOVA|||||0.27|-0.04|
71906038|NCT00838916|143334205|NON_INFERIORITY_OR_EQUIVALENCE|To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%||||||0.0086||||||p-value is for non-inferiority testing of albiglutide versus insulin glargine|t-test, 1 sided|||||||0.0086
71906039|NCT00838916|143334205|SUPERIORITY_OR_OTHER|||||||0.1463||||||p-value is for superiority testing of albiglutide versus insulin glargine|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - insulin glargine) is equal to zero.||||||0.1463
71906040|NCT02164513|143334234|SUPERIORITY||Rate ratio|0.75|||<|0.001|TWO_SIDED|95.0|0.7|0.81||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.81|0.70|<0.001
71906041|NCT02164513|143334234|SUPERIORITY||Rate ratio|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.9||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons|Negative binomial model||Covariates of treatment group, sex, exacerbation history (\<=1, \>=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.|||0.90|0.80|<0.001
71906042|NCT02164513|143334235|SUPERIORITY||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.0061|<|0.001|TWO_SIDED|95.0|0.085|0.109||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI versus (vs) FF/VI at Week 52.|Mixed Models Repeated Measures|||||0.109|0.085|<0.001
71906043|NCT02164513|143334236|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.4|-1.1||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI vs FF/VI at Week 52.|Mixed Models Repeated Measures|||||-1.1|-2.4|<0.001
71906044|NCT02164513|143334237|SUPERIORITY||Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.8|0.91||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Cox proportional hazard model|||||0.91|0.80|<0.001
71906045|NCT02164513|143334237|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.001|TWO_SIDED|95.0|0.78|0.91|||Cox proportional hazard model|||||0.91|0.78|<0.001
71906046|NCT02164513|143334238|SUPERIORITY||Rate ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.62|0.75|||Negative binomial Model|||||0.75|0.62|<0.001
71857225|NCT01123512|143228763|NON_INFERIORITY_OR_EQUIVALENCE|"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|% Probability of Equivalence = 99.92|99.92|||||TWO_SIDED|||||"Pr( Pt - Pc \> -12.5% \| data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc \> -12.5% \| data)\> 96.6%."|Bayesian test of proportions|||||||
71857226|NCT00691678|143228770|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.004|TWO_SIDED||||||t-test, 2 sided|||This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.||||0.004
71857227|NCT00496834|143228771|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= -1.5m/s|Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|1.43|||TWO_SIDED|95.0|-0.83|0.01|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).||0.01|-0.83|
71857228|NCT00496834|143228772|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin=-1.5m/s|Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|1.4|||TWO_SIDED|95.0|-0.86|0.15|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.||0.15|-0.86|
71857229|NCT00496834|143228773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9032||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test.||||||0.9032
71857230|NCT00496834|143228774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6574||95.0||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test||||||0.6574
71857231|NCT01227928|143228775|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.984|||||TWO_SIDED|95.0|0.595|1.626|||||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.|||1.626|0.595|
71857232|NCT01227928|143228776|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.811||||0.5901|TWO_SIDED|95.0|0.376|1.751|||Log Rank||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.|||1.751|0.376|0.5901
71857233|NCT01494298|143228790|SUPERIORITY_OR_OTHER||||||=|0.002||95.0||||The control group average age was 6 years lower(P=0.001). Results were adjusted via a logistic regression and presented as age-adjusted means and SE. The unadjusted differences had similar results.|t-test, 2 sided|||Hypothesis - There will be differences in ApoB between AA with T2DM and those without. To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05. Continuous data were compared using a Students t-test and categorical data were compared using test.||||=0.002
71857234|NCT01494298|143228792|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||t-test, 2 sided|||||||0.84
71857235|NCT02930837|143228793|SUPERIORITY||Percentage of patients|63.3|||<|0.0001|TWO_SIDED|95.0|54.42|71.42|||One-sample test||Percentage of patients with Favourable outcome|A null hypothesis of p ≤40% versus the alternative hypothesis of p \>40% was tested using a one sample test at two-sided significance level of 0.05, where p denoted the response rate in Chinese patients who were treated within 3-4.5 h after stroke onset.||71.42|54.42|<0.0001
71857236|NCT01393613|143228800|SUPERIORITY_OR_OTHER|||||||0.0093|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.||||0.0093
71857237|NCT01393613|143228800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.47||||0.0022|TWO_SIDED|95.0|-10.6|-2.35|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-2.35|-10.6|0.0022
71857238|NCT01393613|143228800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.1448|TWO_SIDED|95.0|-7.23|1.07|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.07|-7.23|0.1448
71857239|NCT01393613|143228800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.37||||0.1588|TWO_SIDED|95.0|-8.06|1.32|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.||1.32|-8.06|0.1588
71857240|NCT01393613|143228801|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6.||||0.0069
71857241|NCT01393613|143228801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.0015|TWO_SIDED|95.0|-0.62|-0.15|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. The analysis of this key secondary endpoint was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Because only the comparison of brexpiprazole 4 mg/day vs placebo met the threshold in the primary analysis, the following analysis is not part of the formal statistical testing and is descriptive only.||-0.15|-0.62|0.0015
71906047|NCT02164513|143334239|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.7|0.85|||Cox proportional hazard model|||||0.85|0.70|<0.001
71857242|NCT01393613|143228801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1269|TWO_SIDED|95.0|-0.42|-0.05|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.05|-0.42|0.1269
71857243|NCT01393613|143228801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.4449|TWO_SIDED|95.0|-0.37|0.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.16|-0.37|0.4449
71857244|NCT01393613|143228802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.59||||0.0005|TWO_SIDED|95.0|2.02|7.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||7.17|2.02|0.0005
71857245|NCT01393613|143228802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.1286|TWO_SIDED|95.0|-0.58|4.59|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||4.59|-0.58|0.1286
71857246|NCT01393613|143228802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0332|TWO_SIDED|95.0|0.26|6.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||6.16|0.26|0.0332
71857247|NCT01393613|143228803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.0166|TWO_SIDED|95.0|-3.08|-0.31|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.31|-3.08|0.0166
71857248|NCT01393613|143228803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.5101|TWO_SIDED|95.0|-1.86|0.93|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.93|-1.86|0.5101
71857249|NCT01393613|143228803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.3938|TWO_SIDED|95.0|-2.26|0.89|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.89|-2.26|0.3938
71857250|NCT01393613|143228804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0231|TWO_SIDED|95.0|-2.28|-0.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.17|-2.28|0.0231
71857251|NCT01393613|143228804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.1547|TWO_SIDED|95.0|-1.83|0.29|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.29|-1.83|0.1547
71857252|NCT01393613|143228804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2004|TWO_SIDED|95.0|-1.98|0.42|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.42|-1.98|0.2004
71857253|NCT01393613|143228805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0009|TWO_SIDED|95.0|-0.78|-0.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-0.78|0.0009
71857254|NCT01393613|143228805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0422|TWO_SIDED|95.0|-0.6|-0.01|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.01|-0.60|0.0422
71857255|NCT01393613|143228805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.1358|TWO_SIDED|95.0|-0.56|0.08|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.08|-0.56|0.1358
71857256|NCT01393613|143228806|SUPERIORITY_OR_OTHER||Relative Risk|1.54||||0.0006|TWO_SIDED|95.0|1.2|2.0|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||2.00|1.20|0.0006
71857257|NCT01393613|143228806|SUPERIORITY_OR_OTHER||Relative Risk|1.22||||0.168|TWO_SIDED|95.0|0.92|1.62|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.62|0.92|0.1680
71857258|NCT01393613|143228806|SUPERIORITY_OR_OTHER||Relative Risk|1.35||||0.0433|TWO_SIDED|95.0|1.02|1.79|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.79|1.02|0.0433
71906048|NCT02164513|143334240|SUPERIORITY||Rate Ratio|0.87||||0.064|TWO_SIDED|95.0|0.76|1.01|||Negative binomial model|||||1.01|0.76|0.064
71906049|NCT02164513|143334240|SUPERIORITY||Rate ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.56|0.78|||Negative binomial model|||||0.78|0.56|<0.001
71906050|NCT03353753|143334262|SUPERIORITY||Hazard Ratio, log|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.25||Two-sided P-value|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.25|0.09|<0.0001
71906051|NCT03353753|143334263|SUPERIORITY|||||||0.0504||||||Two-sided P-value|Fisher Exact|||||||0.0504
71681185|NCT00772005|142881157|SUPERIORITY_OR_OTHER|||||||0.2447||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2447
71857259|NCT01393613|143228807|SUPERIORITY_OR_OTHER||Relative Risk|0.82||||0.5202|TWO_SIDED|95.0|0.44|1.51|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||1.51|0.44|0.5202
71857260|NCT01393613|143228807|SUPERIORITY_OR_OTHER||Relative Risk|1.0||||0.9894|TWO_SIDED|95.0|0.55|1.85|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.85|0.55|0.9894
71857261|NCT01393613|143228807|SUPERIORITY_OR_OTHER||Relative Risk|0.76||||0.4586|TWO_SIDED|95.0|0.36|1.59|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.59|0.36|0.4586
71857262|NCT01393613|143228808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0029|TWO_SIDED|95.0|-2.3|-0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.48|-2.30|0.0029
71906052|NCT03353753|143334265|SUPERIORITY||Hazard Ratio (HR)|0.36||||0.0004|TWO_SIDED|95.0|0.21|0.62||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR and OS.|Log Rank|Strata: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)|Ripretinib: Placebo; based on stratified Cox Proportional Hazards Regression Model using randomization stratification factors \[prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)\]|||0.62|0.21|0.0004
71906053|NCT03353753|143334266|SUPERIORITY|||||||0.001||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.001
71906054|NCT03353753|143334267|SUPERIORITY|||||||0.004||||||Not evaluated for statistical significance as a result of the sequential testing procedure for the secondary endpoints of ORR, OS, and QOL.|ANCOVA|Factors: prior lines of therapy (3 versus ≥4); ECOG (0 versus 1 or 2)||||||0.004
71857263|NCT01393613|143228808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.3559|TWO_SIDED|95.0|-1.34|0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.48|-1.34|0.3559
71857264|NCT01393613|143228808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.3646|TWO_SIDED|95.0|-1.51|0.56|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.56|-1.51|0.3646
71857265|NCT01393613|143228809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.1273|TWO_SIDED|95.0|-2.61|0.33|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||0.33|-2.61|0.1273
71857266|NCT01393613|143228809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.64|TWO_SIDED|95.0|-1.83|1.12|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||1.12|-1.83|0.6400
71857267|NCT01393613|143228809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4423|TWO_SIDED|95.0|-2.32|1.01|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||1.01|-2.32|0.4423
71857268|NCT01393613|143228810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0194|TWO_SIDED|95.0|-2.36|-0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.21|-2.36|0.0194
71857269|NCT01393613|143228810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.0754|TWO_SIDED|95.0|-2.06|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.10|-2.06|0.0754
71857270|NCT01393613|143228810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.108|TWO_SIDED|95.0|-2.22|0.22|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.22|-2.22|0.1080
71857271|NCT01393613|143228811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0045|TWO_SIDED|95.0|-2.34|-0.43|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.||-0.43|-2.34|0.0045
71906055|NCT03353753|143334268|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71906056|NCT00205699|143334288|SUPERIORITY||||||<|0.0001||||||The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.0001
71906057|NCT00205699|143334289|SUPERIORITY|||||||0.07|||||||ANCOVA|||||||0.07
71857272|NCT01393613|143228811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4753|TWO_SIDED|95.0|-1.31|0.61|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.61|-1.31|0.4753
71857273|NCT01393613|143228811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.115|TWO_SIDED|95.0|-1.96|0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.21|-1.96|0.1150
71857274|NCT01393613|143228812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0021|TWO_SIDED|95.0|-2.05|-0.46|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.46|-2.05|0.0021
71857275|NCT01393613|143228812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.6792|TWO_SIDED|95.0|-0.97|0.63|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||0.63|-0.97|0.6792
71857276|NCT01393613|143228812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.5752|TWO_SIDED|95.0|-1.16|0.65|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.65|-1.16|0.5752
71857277|NCT01393613|143228813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86||||0.0104|TWO_SIDED|95.0|-1.51|-0.2|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.||-0.20|-1.51|0.0104
71857278|NCT01393613|143228813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0373|TWO_SIDED|95.0|-1.35|-0.04|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.||-0.04|-1.35|0.0373
71857279|NCT01393613|143228813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.089|TWO_SIDED|95.0|-1.39|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.||0.10|-1.39|0.0890
71857280|NCT02598934|143228861|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.002|TWO_SIDED|95.0|6.1|27.7||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate was effective in treating osteoporosis|Chi-squared, Corrected|||||27.7|6.1|0.002
71857281|NCT02598934|143228861|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.009|TWO_SIDED|95.0|4.0|25.8||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate reduces risk of breaking bone.|Chi-squared, Corrected|||||25.8|4.0|0.009
71857282|NCT02598934|143228861|SUPERIORITY_OR_OTHER||Difference in percentage of participants|16.9||||0.001|TWO_SIDED|95.0|6.3|27.5|||Chi-squared, Corrected|P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis or reduces risk of breaking bone.||||27.5|6.3|0.001
71857283|NCT02598934|143228861|SUPERIORITY_OR_OTHER||Difference in percentage of participants|14.9||||0.01|TWO_SIDED|95.0|3.9|25.9||P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis and reduces risk of breaking bone.|Chi-squared, Corrected|||||25.9|3.9|0.010
71857284|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.||||0.377
71857285|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.||||0.051
71857286|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.||||0.282
71857287|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.||||0.277
71857288|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.||||0.308
71857289|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.211
71906058|NCT00205699|143334290|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
71906059|NCT00205699|143334291|SUPERIORITY|||||||0.17|||||||ANCOVA|||||||0.17
71857290|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.004
71857291|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.||||0.221
71857292|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.||||0.796
71857293|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.||||0.463
71857294|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.||||0.118
71857295|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.||||0.0001
71857296|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.||||0.0001
71857297|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.||||0.0001
71857298|NCT02672514|143228862|SUPERIORITY_OR_OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.||||0.171
71857299|NCT02188784|143228864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.03||||0.457|TWO_SIDED|95.0|-34.38|76.43|||Regression, Linear|||||76.43|-34.38|0.4570
71857300|NCT02188784|143228865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77||||0.9487|TWO_SIDED|95.0|-24.12|22.59|||Regression, Linear|||Change from Baseline to Week 8||22.59|-24.12|0.9487
71857301|NCT02188784|143228865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.67||||0.1921|TWO_SIDED|95.0|-31.71|6.37|||Regression, Linear|||Change from Baseline to Week 16||6.37|-31.71|0.1921
71857302|NCT02188784|143228866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|182.43||||0.4296|TWO_SIDED|95.0|-272.14|637.0|||Regression, Linear|||||637.0|-272.14|0.4296
71857303|NCT02188784|143228867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.6||||0.0722|TWO_SIDED|95.0|-0.33|7.52|||Regression, Linear|||Change from baseline to week 8||7.52|-0.33|0.0722
71857304|NCT02188784|143228867|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71||||0.6927|TWO_SIDED|95.0|-2.83|4.24|||Regression, Linear|||Change from baseline to week 16||4.24|-2.83|0.6927
71857305|NCT02188784|143228868|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.56||||0.0643|TWO_SIDED|95.0|-0.21|7.33|||Regression, Linear|||||7.33|-0.21|0.0643
71857306|NCT02188784|143228869|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.4006|TWO_SIDED|95.0|-1.04|2.58|||Regression, Linear|||||2.58|-1.04|0.4006
71857307|NCT04333732|143228920|SUPERIORITY||Risk Difference (RD)|0.3||||0.52|TWO_SIDED|95.0|-0.5|1.1|||Regression, Logistic|||The primary endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.1|-0.5|0.52
71857308|NCT04333732|143228921|SUPERIORITY||Risk Difference (RD)|0.04||||0.95|TWO_SIDED|95.0|-1.4|1.3|||Regression, Logistic|difference, 0·04%, 95% CI, -1·4% to 1·3%, p=0·95).||The endpoint was analysed using a Bayesian logistic regression, including as covariates the treatment arm, age (\<50 vs. ≥50), and a random effect for site||1.3|-1.4|0.95
71857309|NCT00511836|143228925|SUPERIORITY_OR_OTHER||||||<|2e-05|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0.||||<0.00002
71857310|NCT00511836|143228928|SUPERIORITY_OR_OTHER||||||<|0.013|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||<0.013
71857311|NCT00511836|143228929|SUPERIORITY_OR_OTHER|||||||0.245|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0||||0.245
71857312|NCT01936324|143228930|OTHER|||||||0.0003|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center.||||||0.0003
71857313|NCT01936324|143228931|OTHER|||||||0.0032|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center||||||0.0032
71857314|NCT01936324|143228932|OTHER|||||||0.007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study center||||||0.0070
71857315|NCT04190225|143228941|SUPERIORITY||Median Difference (Final Values)|18.4||||0.04|TWO_SIDED|95.0|4.67|37.28|||quantile regression||Median difference is not the difference in the two medians, but is the median of differences between groups (why it is 18.4 and not 23)|||37.28|4.67|0.04
71857316|NCT04190225|143228942|SUPERIORITY||Median Difference (Final Values)|23.5||||0.03|TWO_SIDED|95.0|8.35|32.76|||quantile regression|||||32.76|8.35|0.03
71857317|NCT00477464|143228970|SUPERIORITY_OR_OTHER||percentage of participants|59.0|||||TWO_SIDED|95.0|44.2|72.4|||||The estimated value represents the percentage of participants who achieved a best overall response of complete response, partial response, or stable disease.|||72.4|44.2|
71906060|NCT00205699|143334292|SUPERIORITY|||||||0.29|||||||ANCOVA|||||||0.29
71857318|NCT00863798|143228992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.175|TWO_SIDED|95.0|-0.38|2.1||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||2.10|-0.38|0.175
71857319|NCT00863798|143228992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51||||0.421|TWO_SIDED|95.0|-0.73|1.75||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.||1.75|-0.73|0.421
71857320|NCT00863798|143228993|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.076
71906061|NCT00205699|143334293|SUPERIORITY||||||<|0.003|||||||ANCOVA|||Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).||||<0.003
71857321|NCT00863798|143228993|SUPERIORITY_OR_OTHER|||||||0.204|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.204
71906062|NCT00205699|143334293|SUPERIORITY|||||||0.003||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|Contrast|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.003
71857322|NCT00863798|143228994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.13|TWO_SIDED|95.0|-0.04|0.35|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.35|-0.04|0.130
71857323|NCT00863798|143228994|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.757|TWO_SIDED|95.0|-0.16|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-0.16|0.757
71857324|NCT00863798|143228995|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.41||||0.114|TWO_SIDED|95.0|-0.34|3.16|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.16|-0.34|0.114
71857325|NCT00863798|143228995|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.316|TWO_SIDED|95.0|-0.85|2.64|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.64|-0.85|0.316
71857326|NCT00863798|143228996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.054|TWO_SIDED|95.0|-0.01|1.5|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.50|-0.01|0.054
71857327|NCT00863798|143228996|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.253|TWO_SIDED|95.0|-0.32|1.2|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.20|-0.32|0.253
71857328|NCT00863798|143228997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.254||||0.2415|TWO_SIDED|95.0|0.86|1.83|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.83|0.86|0.2415
71857329|NCT00863798|143228997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.102||||0.6169|TWO_SIDED|95.0|0.75|1.61|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.61|0.75|0.6169
71857330|NCT00863798|143228998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.236||||0.3667|TWO_SIDED|95.0|0.78|1.96|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.96|0.78|0.3667
71857331|NCT00863798|143228998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.6509|TWO_SIDED|95.0|0.55|1.45|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.45|0.55|0.6509
71857332|NCT00863798|143228999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.182||||0.3893|TWO_SIDED|95.0|0.81|1.73|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.73|0.81|0.3893
71857333|NCT00863798|143228999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.123||||0.551|TWO_SIDED|95.0|0.77|1.65|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.65|0.77|0.5510
71857334|NCT00863798|143229000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.442||||0.0536|TWO_SIDED|95.0|0.99|2.09|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||2.09|0.99|0.0536
71857335|NCT00863798|143229000|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.085||||0.6679|TWO_SIDED|95.0|0.75|1.57|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.||1.57|0.75|0.6679
71906063|NCT00205699|143334293|SUPERIORITY|||||||0.002||||||Bonferroni correction for multiple comparisons was applied (p\<0.05/4 = 0.0125).|ANCOVA|Contrasts based on the ANCOVA-derived time by treatment condition interaction.||||||0.002
71857336|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46||||0.033|TWO_SIDED|95.0|0.12|2.79|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.79|0.12|0.033
71857337|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.096|TWO_SIDED|95.0|-0.2|2.49|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."||2.49|-0.20|0.096
71857338|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48||||0.043|TWO_SIDED|95.0|0.02|0.95|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||0.95|0.02|0.043
71857339|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.027|TWO_SIDED|95.0|0.06|1.0|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."||1.00|0.06|0.027
71857340|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.045|TWO_SIDED|95.0|0.01|0.98|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.98|0.01|0.045
71857341|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.277|TWO_SIDED|95.0|-0.22|0.76|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."||0.76|-0.22|0.277
71857342|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45||||0.056|TWO_SIDED|95.0|-0.01|0.91|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.91|-0.01|0.056
71857343|NCT00863798|143229002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.355|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."||0.68|-0.24|0.355
71857344|NCT00863798|143229003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.002|TWO_SIDED|95.0|-2.53|-0.56|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||-0.56|-2.53|0.002
71857345|NCT00863798|143229003|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77||||0.129|TWO_SIDED|95.0|-1.75|0.22|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.22|-1.75|0.129
71857346|NCT00863798|143229004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3097|TWO_SIDED|95.0|0.52|1.23|||Regression, Linear|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.23|0.52|0.3097
71857347|NCT00863798|143229004|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.272||||0.2794|TWO_SIDED|95.0|0.82|1.97|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.97|0.82|0.2794
71857348|NCT00863798|143229006|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
71857349|NCT00863798|143229006|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.805
71857350|NCT00863798|143229006|SUPERIORITY_OR_OTHER|||||||0.978|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.978
71681186|NCT00772005|142881158|SUPERIORITY_OR_OTHER|||||||0.6115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6115
71857351|NCT00863798|143229006|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Regression, Logistic|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.||||0.805
71857352|NCT00863798|143229006|SUPERIORITY_OR_OTHER|||||||0.154|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.||||0.154
71857353|NCT00863798|143229006|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.||||0.805
71857354|NCT01917006|143229053|SUPERIORITY||Least square mean difference|0.11||||0.393||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.|ANCOVA|||||||0.393
71857355|NCT01917006|143229053|SUPERIORITY||Least Square Mean Difference|0.25||||0.263||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.263
71857356|NCT01917006|143229053|SUPERIORITY||Least square mean difference|-0.39||||0.861||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.861
71857357|NCT01917006|143229053|SUPERIORITY||Least square mean difference|-0.14||||0.647||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.647
71857358|NCT01917006|143229053|SUPERIORITY||Least square mean difference|-0.13||||0.645||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.645
71857359|NCT01917006|143229053|SUPERIORITY||Least square mean difference|0.15||||0.343||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||||||0.343
71857360|NCT01917006|143229054|SUPERIORITY||Least square mean difference|55.33||||0.184||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2||||0.184
71857361|NCT01917006|143229054|SUPERIORITY||Least square mean difference|170.21||||0.002||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.002
71857362|NCT01917006|143229054|SUPERIORITY||Least square mean difference|12.73||||0.404||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.404
71857363|NCT01917006|143229054|SUPERIORITY||Least square mean difference|24.23||||0.328||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.328
71857364|NCT01917006|143229054|SUPERIORITY||Least square mean difference|18.48||||0.362||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.362
71857365|NCT01917006|143229054|SUPERIORITY||Least square mean difference|45.42||||0.203||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.203
71857366|NCT01917006|143229054|SUPERIORITY||Least square mean difference|33.05||||0.322||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.322
71857367|NCT01917006|143229054|SUPERIORITY||Least square mean difference|148.86||||0.015||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.015
71857368|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-6.2||||0.541||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.541
71857369|NCT01917006|143229054|SUPERIORITY||Least square mean difference|6.47||||0.459||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.459
71857370|NCT01917006|143229054|SUPERIORITY||Least square mean difference|1.32||||0.491||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.491
71857371|NCT01917006|143229054|SUPERIORITY||Least square mean difference|36.8||||0.281||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.281
71857372|NCT01917006|143229054|SUPERIORITY||Least square mean difference|14.12||||0.424||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.424
71681187|NCT00772005|142881158|SUPERIORITY_OR_OTHER|||||||0.2233||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2233
71857373|NCT01917006|143229054|SUPERIORITY||Least square mean difference|136.96||||0.026||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.026
71857374|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-27.62||||0.67||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.670
71857375|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-10.06||||0.561||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.561
71857376|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-16.58||||0.604||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.604
71857377|NCT01917006|143229054|SUPERIORITY||Least square mean difference|17.76||||0.394||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.394
71906064|NCT01546285|143334298|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|4.8|||TWO_SIDED|95.0|-2.58|-0.22|||Compare the mean difference with 5mmHg|||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.||-0.22|-2.58|
71906065|NCT01546285|143334298|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|2.6|||TWO_SIDED|95.0|-3.95|-2.66||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.66|-3.95|
71906066|NCT01546285|143334298|NON_INFERIORITY_OR_EQUIVALENCE|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.7|STANDARD_DEVIATION|4.2|||TWO_SIDED|95.0|-4.73|-2.67||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.||-2.67|-4.73|
71906067|NCT02093234|143334299|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71906068|NCT02093234|143334300|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71857378|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-5.94||||0.532||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.532
71906069|NCT02093234|143334301|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71857379|NCT01917006|143229054|SUPERIORITY||Least square mean difference|111.27||||0.058||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.058
71857380|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-48.65||||0.778||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.778
71906070|NCT02093234|143334302|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank|||||||0.02
71857381|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-27.74||||0.662||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.662
71857382|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-35.72||||0.712||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.712
71857383|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-0.18||||0.501||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.501
71857384|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-12.14||||0.565||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.565
71681188|NCT00772005|142881158|SUPERIORITY_OR_OTHER|||||||0.2343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2343
71857385|NCT01917006|143229054|SUPERIORITY||Least square mean difference|102.44||||0.071||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.071
71857386|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-52.81||||0.799||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.799
71857387|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-30.81||||0.681||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.681
71857388|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-40.68||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.741
71857389|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-4.33||||0.526||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.526
71857390|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-14.76||||0.584||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 12||||0.584
71857391|NCT01917006|143229054|SUPERIORITY||Least square mean difference|84.09||||0.101||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 12||||0.101
71857392|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-55.14||||0.823||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 12||||0.823
71681189|NCT00772005|142881159|SUPERIORITY_OR_OTHER|||||||0.8228||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8228
71857393|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-40.18||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 12||||0.741
71857394|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-41.31||||0.756||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 12||||0.756
71857395|NCT01917006|143229054|SUPERIORITY||Least square mean difference|-2.57||||0.517||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 12||||0.517
71857396|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.59||||0.079||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 2||||0.079
71857397|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.77||||0.025||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2||||0.025
71857398|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.07||||0.417||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2||||0.417
71857399|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.16||||0.33||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2||||0.330
71857400|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.3||||0.199||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2||||0.199
71906071|NCT01170702|143334312|NON_INFERIORITY|The non inferiority margin is clinically important reduction in 24 hour hydromorphone consumption of 25%, 37.5% and 50% absolute reduction, compared with control.|Median Difference (Final Values)|1.25|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|0.975|1.25|1.25|||Kruskal-Wallis|||||1.25|1.25|.05
71906072|NCT01677507|143334320|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.4|3.3|||t-test, 2 sided|Actually these are 2 sided paired t-tests.||Right Eye treated vs. untreated||3.3|2.4|0.0001
71906073|NCT01677507|143334320|OTHER||Mean Difference (Final Values)|2.8||||0.0001|TWO_SIDED|95.0|2.5|3.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye treated vs. untreated||3.2|2.5|0.0001
71906074|NCT01677507|143334320|OTHER||Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|2.5|3.4|||t-test, 2 sided|paired t-test, 2 sided||Right Eye treated vs. untreated||3.4|2.5|0.0001
71906075|NCT01677507|143334320|OTHER||Mean Difference (Final Values)|2.9||||0.0001|TWO_SIDED|95.0|2.5|3.3|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||3.3|2.5|0.0001
71906076|NCT01677507|143334321|OTHER||Median Difference (Final Values)|1.1||||0.0001|TWO_SIDED|95.0|0.9|1.3|||t-test, 2 sided|paired t test, 2 sided||Right Eye treated to untreated||1.3|0.9|0.0001
71906077|NCT01677507|143334321|OTHER||Median Difference (Final Values)|0.9||||0.0001|TWO_SIDED|95.0|0.7|1.1|||t-test, 2 sided|paired t test, 2 sided||Left Eye, treated vs. untreated||1.1|0.7|0.0001
71906078|NCT01677507|143334321|OTHER||Mean Difference (Final Values)|0.01||||0.94|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|paired t-test||Right Eye, treated vs. untreated||0.2|-0.2|0.94
71906079|NCT01677507|143334321|OTHER||Mean Difference (Final Values)|0.05||||0.54|TWO_SIDED|95.0|-0.1|0.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.2|-0.1|0.54
71906080|NCT01677507|143334322|OTHER||Mean Difference (Final Values)|0.4||||0.04|TWO_SIDED|95.0|0.01|0.7|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.7|0.01|0.04
71906081|NCT01677507|143334322|OTHER||Mean Difference (Final Values)|0.2||||0.15|TWO_SIDED|95.0|-0.1|0.6|||t-test, 2 sided|paired t-test, 2 sided||Left eye, treated vs. untreated||0.6|-0.1|0.15
71906082|NCT01677507|143334322|OTHER||Mean Difference (Final Values)|0.1||||0.52|TWO_SIDED|95.0|-0.3|0.6|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated||0.6|-0.3|0.52
71906083|NCT01677507|143334322|OTHER||Mean Difference (Final Values)|0.03||||0.88|TWO_SIDED|95.0|-0.4|0.4|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated||0.4|-0.4|0.88
71906084|NCT05137730|143334376|OTHER||Ratio of geometric least squares means|0.78|||||TWO_SIDED|90.0|0.7109|0.8611|||||Least squares means (LSMs) were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8611|0.7109|
71906085|NCT05137730|143334377|OTHER||Dose effect|1.5395|STANDARD_ERROR_OF_MEAN|0.121|||TWO_SIDED|95.0|1.2929|1.7862||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.7862|1.2929|
71906086|NCT05137730|143334378|OTHER||Ratio of geometric least squares means|0.84|||||TWO_SIDED|90.0|0.7576|0.9375|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.9375|0.7576|
71906087|NCT05137730|143334379|OTHER||Dose effect|1.2823|STANDARD_ERROR_OF_MEAN|0.1072|||TWO_SIDED|95.0|1.0431|1.5215||||||A linear regression model using was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.5215|1.0431|
71906088|NCT05137730|143334380|OTHER||Ratio of geometric least squares means|0.81|||||TWO_SIDED|90.0|0.7462|0.8893|||||LSMs were calculated by exponentiating the LSMs derived from the linear mixed effects model.|||0.8893|0.7462|
71906089|NCT05137730|143334381|OTHER||Dose effect|1.0937|STANDARD_ERROR_OF_MEAN|0.0763|||TWO_SIDED|95.0|0.938|1.2493||||||A linear regression model was used, including sequence and period as fixed effects, subject within sequence as a random effect, and ln(dose) as a covariate.||1.2493|0.9380|
71921946|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-11.6|0.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||0.2|-11.6|
71921947|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-10.6|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||1.5|-10.6|
71921948|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-7.4|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||6.4|-7.4|
71921949|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.3|4.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||4.7|-9.3|
71921950|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.4|4.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||4.6|-9.4|
71921951|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-8.7|5.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||5.6|-8.7|
71921952|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.7|-6.2|
71906090|NCT00077610|143334406|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.004|STANDARD_ERROR_OF_MEAN|0.0973|<|0.0001|TWO_SIDED|97.5|-0.215|0.223|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.||0.223|-0.215|<0.0001
71906091|NCT00077610|143334406|NON_INFERIORITY_OR_EQUIVALENCE|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.051|STANDARD_ERROR_OF_MEAN|0.0997|<|0.0001|TWO_SIDED|97.5|-0.173|0.275|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.||0.275|-0.173|<0.0001
71906092|NCT00304915|143334417|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.003|TWO_SIDED|95.0|1.37|4.56|||Regression, Logistic|||||4.56|1.37|0.003
71906093|NCT04124042|143334418|SUPERIORITY||Odds Ratio (OR)|0.655|||||TWO_SIDED|95.0|0.347|1.237||||||||1.237|0.347|
71906094|NCT04124042|143334418|SUPERIORITY||Odds Ratio (OR)|0.714|||||TWO_SIDED|95.0|0.381|1.336||||||||1.336|0.381|
71906095|NCT04124042|143334419|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.539||0.413|TWO_SIDED|95.0|-0.62|1.5|||Mixed Models Analysis|||||1.50|-0.62|0.413
71906096|NCT04124042|143334419|SUPERIORITY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.535||0.629|TWO_SIDED|95.0|-0.79|1.31|||Mixed Models Analysis|||||1.31|-0.79|0.629
71906097|NCT04124042|143334424|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.1374|TWO_SIDED|95.0|-0.16|1.16|||Mixed Models Analysis|||||1.16|-0.16|0.1374
71906098|NCT04124042|143334424|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.2807|TWO_SIDED|95.0|-0.29|1.0|||Mixed Models Analysis|||||1.00|-0.29|0.2807
71906099|NCT04124042|143334425|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.142||0.346|TWO_SIDED|95.0|-0.14|0.41|||Mixed Models Analysis|||||0.41|-0.14|0.346
71906100|NCT04124042|143334425|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.14||0.968|TWO_SIDED|95.0|-0.27|0.28|||Mixed Models Analysis|||||0.28|-0.27|0.968
71906101|NCT04124042|143334427|SUPERIORITY||Mean Difference (Final Values)|-2.83||||0.0081|TWO_SIDED|95.0|-4.91|-0.75|||Mixed Models Analysis|||Outcome measure #10 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #12 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-0.75|-4.91|0.0081
71906102|NCT04124042|143334428|SUPERIORITY||Mean Difference (Final Values)|-9.6||||0.0101|TWO_SIDED|95.0|-16.85|-2.34|||Mixed Models Analysis|||Outcome measure #11 is an analysis of 2 tx groups (two doses of 0.45 mg/ml vs. a single dose of 0.45 mg/ml), whereas outcome measure #13 is all 6 tx groups. A MMRM model was used. LS Means in an MMRM model are influenced by the overall mean structure and covariance estimation. When fewer treatment groups are included, the model adjusts based on a different subset of data, leading to potential shifts in estimated LS Means due to changes in the reference population/covariance structure.||-2.34|-16.85|0.0101
71906103|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.3|<0.001
71921953|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-6.2|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||6.8|-6.2|
71921954|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.4|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.4|-6.4|
71921955|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.3|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||6.8|-9.3|
71921956|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.0|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.4|-10.0|
71921957|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.3|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||1.3|-10.3|
71921958|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-8.2|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||3.3|-8.2|
71857401|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.45||||0.113||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2||||0.113
71857402|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.5||||0.127||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4||||0.127
71857403|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.56||||0.087||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4||||0.087
71906104|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|9.9|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|6.8|13.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.1|6.8|<0.001
71906105|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|10.7|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|7.7|13.8|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||13.8|7.7|<0.001
71906106|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|13.4|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|10.3|16.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||16.5|10.3|<0.001
71906107|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|4.6|STANDARD_ERROR_OF_MEAN|1.42||0.001|TWO_SIDED|95.0|1.8|7.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||7.4|1.8|0.001
71906108|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|4.1|STANDARD_ERROR_OF_MEAN|1.42||0.004|TWO_SIDED|95.0|1.3|6.9|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||6.9|1.3|0.004
71906109|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|9.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|6.9|12.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||12.5|6.9|<0.001
71906110|NCT01021852|143334442|SUPERIORITY_OR_OTHER||Difference in LS Means|8.7|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|5.9|11.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||11.5|5.9|<0.001
71906111|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.8|STANDARD_ERROR_OF_MEAN|6.29|<|0.001|TWO_SIDED|95.0|-43.2|-18.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.4|-43.2|<0.001
71921959|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-13.0|-1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||-1.3|-13.0|
71857404|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.04||||0.543||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4||||0.543
71681190|NCT00772005|142881159|SUPERIORITY_OR_OTHER|||||||0.9373||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9373
71857405|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.12||||0.377||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4||||0.377
71857406|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.17||||0.321||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4||||0.321
71857407|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.4||||0.149||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4||||0.149
71857408|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.35||||0.215||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6||||0.215
71857409|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.47||||0.126||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6||||0.126
71857410|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.28||||0.774||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6||||0.774
71857411|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.01||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6||||0.495
71857412|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.0||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6||||0.495
71857413|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.23||||0.274||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6||||0.274
71906112|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-32.5|STANDARD_ERROR_OF_MEAN|6.31|<|0.001|TWO_SIDED|95.0|-44.9|-20.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-20.1|-44.9|<0.001
71906113|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.9|STANDARD_ERROR_OF_MEAN|6.21|<|0.001|TWO_SIDED|95.0|-43.2|-18.7|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.7|-43.2|<0.001
71906114|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-45.8|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-58.0|-33.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-33.5|-58.0|<0.001
71906115|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.5|STANDARD_ERROR_OF_MEAN|5.65||0.006|TWO_SIDED|95.0|-26.7|-4.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-4.4|-26.7|0.006
71906116|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-13.2|STANDARD_ERROR_OF_MEAN|5.66||0.02|TWO_SIDED|95.0|-24.4|-2.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.1|-24.4|0.020
71857414|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.22||||0.308||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8||||0.308
71681191|NCT00772005|142881159|SUPERIORITY_OR_OTHER|||||||0.319||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3190
71681192|NCT00772005|142881160|SUPERIORITY_OR_OTHER|||||||0.9769||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9769
71681193|NCT00772005|142881160|SUPERIORITY_OR_OTHER|||||||0.8374||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8374
71857415|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.34||||0.205||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8||||0.205
71857416|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.39||||0.849||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8||||0.849
71857417|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.07||||0.571||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8||||0.571
71857418|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.09||||0.592||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8||||0.592
71857419|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.16||||0.34||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8||||0.340
71857420|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.16||||0.36||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10||||0.360
71857421|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.35||||0.192||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10||||0.192
71857422|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.37||||0.843||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10||||0.843
71857423|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.07||||0.572||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10||||0.572
71857424|NCT01917006|143229055|SUPERIORITY||Least square mean difference|-0.12||||0.628||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10||||0.628
71857425|NCT01917006|143229055|SUPERIORITY||Least square mean difference|0.12||||0.38||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10||||0.380
71857426|NCT01850823|143229099|EQUIVALENCE|Equivalence based on Test/Reference Ratio and 90% confidence interval (as per OGD guidance)|Ratio Test/Reference LS Mean|114.723|||||TWO_SIDED|90.0|99.077|134.286||||||Conducted on Per Protocol Population||134.286|99.077|
71857427|NCT01850823|143229100|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||<0.0001
71681194|NCT00772005|142881160|SUPERIORITY_OR_OTHER|||||||0.7061||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7061
71681195|NCT00772005|142881161|SUPERIORITY_OR_OTHER|||||||0.9577||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9577
71857428|NCT01850823|143229100|SUPERIORITY|||||||0.0002|||||||ANCOVA|||The superiority of treatment over the placebo will be concluded if the treatment's mean change from baseline is statistically significantly greater (p\<0.05, 2-sided) than that of the placebo in the ANCOVA based on the treatment and placebo results. The superiority of Test and Reference treatments over the placebo will be evaluated identically in a separate ANCOVA.||||0.0002
71857429|NCT01751165|143229102|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.16|||||TWO_SIDED|97.5|0.98|1.39|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.||1.39|0.98|
71857430|NCT01751165|143229102|NON_INFERIORITY_OR_EQUIVALENCE|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.19|||||TWO_SIDED|97.5|0.93|1.53|||ANCOVA|||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.||1.53|0.93|
71857431|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67.|GMT ratio|1.9|||<|0.001|TWO_SIDED|95.0|1.7|2.14||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.14|1.70|< 0.001
71857432|NCT00943722|143229160|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.83|||<|0.001|TWO_SIDED|95.0|1.63|2.06||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.06|1.63|< 0.001
71857433|NCT00943722|143229160|NON_INFERIORITY|Non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.98|||<|0.001|TWO_SIDED|95.0|1.77|2.22||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.22|1.77|< 0.001
71857434|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.44|||<|0.001|TWO_SIDED|95.0|2.13|2.8||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||2.80|2.13|< 0.001
71857435|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.51|||<|0.001|TWO_SIDED|95.0|2.21|2.85||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||2.85|2.21|< 0.001
71857436|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.87|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.36|1.87|< 0.001
71906117|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-25.7|STANDARD_ERROR_OF_MEAN|5.67|<|0.001|TWO_SIDED|95.0|-36.8|-14.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.5|-36.8|<0.001
71906118|NCT01021852|143334443|SUPERIORITY_OR_OTHER||Difference in LS Means|-30.0|STANDARD_ERROR_OF_MEAN|5.69|<|0.001|TWO_SIDED|95.0|-41.2|-18.8|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-18.8|-41.2|<0.001
71921960|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.8|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-7.7|2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||2.2|-7.7|
71857437|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.62|||<|0.001|TWO_SIDED|95.0|2.27|3.03||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.03|2.27|< 0.001
71857438|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.22|||<|0.001|TWO_SIDED|95.0|1.97|2.51||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.51|1.97|< 0.001
71857439|NCT00943722|143229160|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.18|||<|0.001|TWO_SIDED|95.0|1.93|2.45||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.45|1.93|< 0.001
71857440|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.31|||<|0.001|TWO_SIDED|95.0|2.07|2.59||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||2.59|2.07|< 0.001
71857441|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|TWO_SIDED|95.0|1.88|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||2.36|1.88|< 0.001
71857442|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.45|||<|0.001|TWO_SIDED|95.0|2.19|2.74||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||2.74|2.19|< 0.001
71857443|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.2|||<|0.001|TWO_SIDED|95.0|2.8|3.65||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||3.65|2.80|< 0.001
71857444|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.95|||<|0.001|TWO_SIDED|95.0|2.6|3.34||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||3.34|2.60|< 0.001
71857445|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.57|||<|0.001|TWO_SIDED|95.0|2.29|2.88||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||2.88|2.29|< 0.001
71857446|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.33|||<|0.001|TWO_SIDED|95.0|2.89|3.84||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||3.84|2.89|< 0.001
71857447|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.47|||<|0.001|TWO_SIDED|95.0|2.19|2.79||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||2.79|2.19|< 0.001
71857448|NCT00943722|143229161|NON_INFERIORITY|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.66|||<|0.001|TWO_SIDED|95.0|2.37|2.98||one-sided tests of non-inferiority conducted at the alpha=0.025 level; model with a response of log individual titers and a fixed effect for comparison group|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||2.98|2.37|< 0.001
71906119|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-10.2|STANDARD_ERROR_OF_MEAN|4.43||0.022|TWO_SIDED|95.0|-18.9|-1.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-1.5|-18.9|0.022
71906120|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-15.7|STANDARD_ERROR_OF_MEAN|4.44|<|0.001|TWO_SIDED|95.0|-24.5|-7.0|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-7.0|-24.5|<0.001
71906121|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-23.5|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-32.1|-14.9|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-14.9|-32.1|<0.001
71906122|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-20.3|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-29.0|-11.7|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-11.7|-29.0|<0.001
71906123|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.9|STANDARD_ERROR_OF_MEAN|4.61||0.055|TWO_SIDED|95.0|-18.0|0.2|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.2|-18.0|0.055
71921961|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.7|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-9.7|0.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||0.3|-9.7|
71857449|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||1.08|0.88|
71857450|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.03|||||TWO_SIDED|95.0|0.93|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.16|0.93|
71857451|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.06|||||TWO_SIDED|95.0|0.95|1.19|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.19|0.95|
71857452|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.11|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||1.11|0.90|
71857453|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
71857454|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||TWO_SIDED|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.20|0.95|
71921962|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.1|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-11.6|3.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.5|-11.6|
71921963|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-12.0|3.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||3.3|-12.0|
71921964|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.6|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||1.9|-10.6|
71921965|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-12.0|0.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||0.7|-12.0|
71921966|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.3|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||10.3|-8.3|
71857455|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||1.06|0.86|
71906124|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-8.7|STANDARD_ERROR_OF_MEAN|4.61||0.06|TWO_SIDED|95.0|-17.8|0.4|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||0.4|-17.8|0.060
71906125|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-19.5|STANDARD_ERROR_OF_MEAN|4.62|<|0.001|TWO_SIDED|95.0|-28.6|-10.4|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-10.4|-28.6|<0.001
71857456|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.12|0.90|
71857457|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.17|0.94|
71857458|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||1.14|0.89|
71857459|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.98|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.98|
71857460|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||TWO_SIDED|95.0|0.97|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.26|0.97|
71857461|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||1.13|0.89|
71857462|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.91|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.16|0.91|
71857463|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.15|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.15|0.90|
71857464|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||1.16|0.94|
71857465|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||TWO_SIDED|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.17|0.94|
71857466|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.12|0.90|
71857467|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.84|||||TWO_SIDED|95.0|0.73|0.95|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.95|0.73|
71857468|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.04|||||TWO_SIDED|95.0|0.91|1.18|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.18|0.91|
71857469|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.24|||||TWO_SIDED|95.0|1.08|1.42|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.42|1.08|
71857470|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.92|||||TWO_SIDED|95.0|0.83|1.03|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||1.03|0.83|
71857471|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.85|1.07|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.07|0.85|
71857472|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.03|||||TWO_SIDED|95.0|0.92|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.16|0.92|
71857473|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||TWO_SIDED|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||1.06|0.86|
71857474|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.07|||||TWO_SIDED|95.0|0.96|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.20|0.96|
71906126|NCT01021852|143334444|SUPERIORITY_OR_OTHER||Difference in LS Means|-11.3|STANDARD_ERROR_OF_MEAN|4.63||0.015|TWO_SIDED|95.0|-20.5|-2.2|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."||-2.2|-20.5|0.015
71906127|NCT01021852|143334445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-9.5|12.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||12.2|-9.5|
71906128|NCT01021852|143334445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-10.3|11.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||11.2|-10.3|
71906129|NCT01021852|143334445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|-4.2|18.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||18.3|-4.2|
71906130|NCT01021852|143334445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||||TWO_SIDED|95.0|-2.3|20.4||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||20.4|-2.3|
71906131|NCT01021852|143334446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|||||TWO_SIDED|95.0|-1.0|10.2||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||10.2|-1.0|
71906132|NCT01021852|143334446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.6|4.8||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||4.8|-3.6|
71906133|NCT01021852|143334446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-2.7|6.6||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||6.6|-2.7|
71906134|NCT01021852|143334446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-4.5|2.3||||||Miettinen and Nurminen's method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.||2.3|-4.5|
71857475|NCT00943722|143229162|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.12|||||TWO_SIDED|95.0|1.0|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.26|1.00|
71857476|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.8|< 0.001
71857477|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
71857478|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
71857479|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.5|-0.8|< 0.001
71857480|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
71906135|NCT02802878|143334461|SUPERIORITY|||||||0.67||||||Adjusted for two observations per subject.|Regression, Linear|Side treated as a repeated factor||||||.67
71906136|NCT00230100|143334598|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
71857481|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
71857482|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.4|||<|0.001|TWO_SIDED|95.0|-0.6|1.8|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||1.8|-0.6|< 0.001
71857483|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
71857484|NCT00943722|143229166|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
71857485|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.1|||<|0.001|TWO_SIDED|95.0|-0.7|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6||1.5|-0.7|< 0.001
71857486|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11||1.2|-0.7|< 0.001
71857487|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16||1.2|-0.7|< 0.001
71857488|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18||1.6|-0.4|< 0.001
71857489|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31||1.7|-0.4|< 0.001
71857490|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33||1.6|-0.4|< 0.001
71857491|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.5|||<|0.001|TWO_SIDED|95.0|-0.1|2.0|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45||2.0|-0.1|< 0.001
71857492|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.3|||<|0.001|TWO_SIDED|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52||1.7|-0.4|< 0.001
71857493|NCT00943722|143229167|NON_INFERIORITY|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.|Percentage Point Difference|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58||1.2|-0.7|< 0.001
71857494|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.9|0.9|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6||0.9|-0.9|
71857495|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.5|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
71857496|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.6|||||TWO_SIDED|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6||1.7|-0.4|
71857497|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11||0.7|-0.7|
71857498|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
71857499|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11||1.3|-0.4|
71681196|NCT00772005|142881161|SUPERIORITY_OR_OTHER|||||||0.5106||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5106
71857500|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16||0.7|-0.7|
71857501|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
71857502|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16||1.3|-0.4|
71857503|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18||0.5|-1.1|
71857504|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.1|-0.7|
71857505|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18||1.3|-0.4|
71857506|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31||0.7|-0.7|
71857507|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.6|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.6|
71857508|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.5|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31||1.0|-0.5|
71857509|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33||0.7|-0.7|
71857510|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
71857511|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33||1.3|-0.4|
71857512|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|-0.2|||||TWO_SIDED|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45||0.5|-1.1|
71857513|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.2|||||TWO_SIDED|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.1|-0.7|
71857514|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45||1.3|-0.4|
71906137|NCT00230100|143334599|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
71681197|NCT00772005|142881161|SUPERIORITY_OR_OTHER|||||||0.2655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2655
71906138|NCT00230100|143334600|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||"Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a mixed model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis)."||||<0.05
71906139|NCT00230100|143334601|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Mixed Models Analysis|||It was hypothesized that the single-gender group composition and women-focused group content (WRG) would result in better substance abuse treatment outcomes (lower ASI alcohol composite scores) than standard mixed-gender group treatment (GDC).||||<0.05
71906140|NCT00230100|143334602|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.009|||||||Mixed Models Analysis|||||||<0.009
71906141|NCT01906866|143334614|SUPERIORITY||Mean Difference (Final Values)|32.32|STANDARD_ERROR_OF_MEAN|15.1|=|0.035|TWO_SIDED|95.0|2.38|62.26|||Mixed Models Analysis|||||62.26|2.38|=0.035
71906142|NCT01906866|143334615|SUPERIORITY||Mean Difference (Final Values)|-25.2|STANDARD_ERROR_OF_MEAN|9.787|=|0.011|TWO_SIDED|95.0|-44.61|-5.8|||Mixed Models Analysis|||||-5.8|-44.61|=0.011
71906143|NCT01906866|143334618|SUPERIORITY|||||||0.053|||||||MMRM|||Mixed Models for Repeated Measures (MMRM) analysis||||0.053
71857515|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52||0.7|-0.7|
71857516|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.3|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
71857517|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52||1.3|-0.4|
71857518|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58||0.7|-0.7|
71857519|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
71857520|NCT00943722|143229168|EQUIVALENCE|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).|Percentage Point Difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58||1.3|-0.4|
71857521|NCT01036165|143229176|SUPERIORITY_OR_OTHER||Mean positive response|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower limit of the 95% confidence interval was \>0.50.|||0.86|0.70|
71857522|NCT01387815|143229184|OTHER||||||<|0.001|||||||Chi-squared|||Comparison does not include missing.||||<0.001
71857523|NCT01387815|143229185|OTHER||||||<|0.001|||||||Log Rank|||||||<0.001
71857524|NCT01387815|143229186|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71857525|NCT01387815|143229187|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71857526|NCT01387815|143229188|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71857527|NCT01387815|143229189|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71857528|NCT01387815|143229190|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71857529|NCT01387815|143229191|OTHER|||||||0.016|||||||t-test, 2 sided|||||||0.016
71857530|NCT01387815|143229192|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.060
71857531|NCT01387815|143229193|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
71857532|NCT01387815|143229194|OTHER|||||||0.755|||||||t-test, 2 sided|||||||0.755
71857533|NCT01387815|143229195|OTHER|||||||0.091|||||||t-test, 2 sided|||||||0.091
71857534|NCT01387815|143229196|OTHER|||||||0.106|||||||t-test, 2 sided|||||||0.106
71857535|NCT01387815|143229197|OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71857536|NCT01387815|143229198|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
71857537|NCT01387815|143229199|OTHER|||||||0.083|||||||t-test, 2 sided|||||||0.083
71857538|NCT01387815|143229200|OTHER|||||||0.495|||||||t-test, 2 sided|||||||0.495
71857539|NCT01387815|143229201|OTHER|||||||0.097|||||||t-test, 2 sided|||||||0.097
71857540|NCT01387815|143229202|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71857541|NCT01387815|143229203|OTHER|||||||0.037|||||||t-test, 2 sided|||||||0.037
71857542|NCT01387815|143229204|OTHER|||||||0.084|||||||t-test, 2 sided|||||||0.084
71857543|NCT01387815|143229205|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.090
71857544|NCT01387815|143229206|OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
71857545|NCT01387815|143229207|OTHER|||||||0.004|||||||t-test, 2 sided|||||||0.004
71857546|NCT01387815|143229208|OTHER|||||||0.115|||||||t-test, 2 sided|||||||0.115
71857547|NCT01387815|143229209|OTHER|||||||0.002|||||||Log Rank|||||||0.002
71857548|NCT01387815|143229210|OTHER|||||||0.002|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.002
71857549|NCT01387815|143229211|OTHER|"Comparison does not include the Missing category."||||||0.017|||||||Chi-squared|||||||0.017
71857550|NCT01387815|143229212|OTHER|||||||0.01||||||"Comparison does not include the Missing category."|Chi-squared|||||||0.010
71857551|NCT01387815|143229213|OTHER|||||||0.015|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.015
71857552|NCT01387815|143229214|OTHER|||||||0.06|||||||Chi-squared|||"Comparison does not include the Missing category."||||0.060
71857553|NCT01387815|143229215|OTHER|||||||0.501|||||||t-test, 2 sided|||||||0.501
71857554|NCT01387815|143229216|OTHER|||||||0.807|||||||t-test, 2 sided|||||||0.807
71857555|NCT01387815|143229217|OTHER|||||||0.479|||||||t-test, 2 sided|||||||0.479
71857556|NCT01387815|143229218|OTHER|||||||0.918|||||||t-test, 2 sided|||||||0.918
71857557|NCT01387815|143229219|OTHER|||||||0.609|||||||t-test, 2 sided|||||||0.609
71857558|NCT01387815|143229220|OTHER|||||||0.367|||||||t-test, 2 sided|||||||0.367
71681198|NCT00772005|142881162|SUPERIORITY_OR_OTHER|||||||0.3825||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3825
71857559|NCT01387815|143229221|OTHER|||||||0.521|||||||t-test, 2 sided|||||||0.521
71857560|NCT01387815|143229222|OTHER|||||||0.793|||||||t-test, 2 sided|||||||0.793
71857561|NCT01387815|143229223|OTHER|||||||0.442|||||||t-test, 2 sided|||||||0.442
71857562|NCT01387815|143229224|OTHER|||||||0.434|||||||t-test, 2 sided|||||||0.434
71857563|NCT01387815|143229225|OTHER|||||||0.752|||||||t-test, 2 sided|||||||0.752
71857564|NCT01387815|143229226|OTHER|||||||0.469|||||||t-test, 2 sided|||||||0.469
71906144|NCT01906866|143334618|SUPERIORITY|||||||0.039|||||||MI analysis|||||||0.039
71906145|NCT01906866|143334620|SUPERIORITY|||||||0.077|||||||MMRM|||||||0.077
71681199|NCT00772005|142881162|SUPERIORITY_OR_OTHER|||||||0.2003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2003
71857565|NCT01387815|143229227|OTHER|||||||0.419|||||||t-test, 2 sided|||||||0.419
71857566|NCT01387815|143229228|OTHER|||||||0.695|||||||t-test, 2 sided|||||||0.695
71857567|NCT01387815|143229229|OTHER|||||||0.452|||||||t-test, 2 sided|||||||0.452
71857568|NCT01387815|143229230|OTHER|||||||0.008|||||||t-test, 2 sided|||||||0.008
71857569|NCT01387815|143229231|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
71857570|NCT01387815|143229232|OTHER|||||||0.252|||||||t-test, 2 sided|||||||0.252
71857571|NCT01387815|143229236|OTHER|||||||0.143|||||||Chi-squared|||||||0.143
71857572|NCT01387815|143229237|OTHER|||||||0.415|||||||Chi-squared|||||||0.415
71857573|NCT01387815|143229238|OTHER|||||||0.604|||||||Chi-squared|||||||0.604
71857574|NCT01387815|143229239|OTHER|||||||0.504|||||||Fisher Exact|||||||0.504
71857575|NCT01387815|143229240|OTHER|||||||0.92|||||||Chi-squared|||||||0.920
71857576|NCT01387815|143229241|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71857577|NCT01387815|143229242|OTHER|||||||0.575|||||||Chi-squared|||||||0.575
71857578|NCT01387815|143229245|OTHER|||||||0.856|||||||Chi-squared|||||||0.856
71857579|NCT01387815|143229246|OTHER|||||||0.623|||||||Chi-squared|||||||0.623
71857580|NCT01387815|143229247|OTHER|||||||0.732|||||||Chi-squared|||||||0.732
71857581|NCT01387815|143229248|OTHER|||||||0.896|||||||t-test, 2 sided|||||||0.896
71857582|NCT01387815|143229249|OTHER|||||||0.879|||||||t-test, 2 sided|||||||0.879
71857583|NCT01387815|143229250|OTHER|||||||0.763|||||||t-test, 2 sided|||||||0.763
71857584|NCT01387815|143229251|OTHER|||||||0.657|||||||Chi-squared|||||||0.657
71857585|NCT01387815|143229252|OTHER|||||||0.987|||||||Chi-squared|||||||0.987
71857586|NCT01387815|143229253|OTHER|||||||0.011|||||||Fisher Exact|||||||0.011
71857587|NCT01387815|143229254|OTHER|||||||0.351|||||||t-test, 2 sided|||||||0.351
71857588|NCT01387815|143229255|OTHER|||||||0.835|||||||t-test, 2 sided|||||||0.835
71857589|NCT01387815|143229257|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
71857590|NCT01387815|143229258|OTHER|||||||0.737|||||||Fisher Exact|||||||0.737
71857591|NCT01387815|143229259|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71857592|NCT01387815|143229263|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71857593|NCT01387815|143229264|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71857594|NCT01387815|143229266|OTHER|||||||0.714|||||||Fisher Exact|||||||0.714
71857595|NCT01387815|143229267|OTHER|||||||0.747|||||||Fisher Exact|||||||0.747
71857596|NCT01387815|143229268|OTHER|||||||0.495|||||||Fisher Exact|||||||0.495
71857597|NCT01387815|143229272|OTHER|||||||0.364|||||||Fisher Exact|||||||0.364
71857598|NCT01387815|143229273|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71857599|NCT01387815|143229274|OTHER|||||||0.723|||||||Fisher Exact|||||||0.723
71857600|NCT01387815|143229281|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71857601|NCT01387815|143229282|OTHER|||||||0.672|||||||t-test, 2 sided|||||||0.672
71857602|NCT01387815|143229283|OTHER|||||||0.482|||||||t-test, 2 sided|||||||0.482
71857603|NCT01387815|143229284|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
71857604|NCT01387815|143229285|OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
71857605|NCT01387815|143229286|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.360
71857606|NCT01387815|143229287|OTHER|||||||0.808|||||||t-test, 2 sided|||||||0.808
71857607|NCT01387815|143229288|OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
71857608|NCT01387815|143229289|OTHER|||||||0.184|||||||t-test, 2 sided|||||||0.184
71857609|NCT01387815|143229290|OTHER|||||||0.305|||||||t-test, 2 sided|||||||0.305
71857610|NCT01387815|143229292|OTHER|||||||0.757|||||||t-test, 2 sided|||||||0.757
71857611|NCT01387815|143229293|OTHER|||||||0.321|||||||t-test, 2 sided|||||||0.321
71857612|NCT01387815|143229294|OTHER|||||||0.181|||||||t-test, 2 sided|||||||0.181
71857613|NCT01387815|143229295|OTHER|||||||0.395|||||||t-test, 2 sided|||||||0.395
71857614|NCT01387815|143229297|OTHER|||||||0.739|||||||t-test, 2 sided|||||||0.739
71857615|NCT01387815|143229298|OTHER|||||||0.291|||||||t-test, 2 sided|||||||0.291
71857616|NCT01844726|143229344|SUPERIORITY||Mean Difference (Net)|0.05||||0.1|TWO_SIDED||||||t-test, 2 sided|||Change in BOLD signal activation across task derived learning circuit were compared between GLYX-13 and placebo groups using an independent group t-test.||||.10
71857617|NCT01844726|143229345|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||.57
71906146|NCT01906866|143334621|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71857618|NCT00307164|143229351|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64||95.0|||||Stratified Wilcoxon rank-sum test|Treatment groups were compared for change in limb fat using a two-sided stratified Wilcoxon rank-sum test (stratified by ARV used)||||||0.64
71857619|NCT00307164|143229352|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Log Rank|||||||0.17
71906147|NCT00438399|143334628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.0003
71906148|NCT00438399|143334628|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||0.007
71906149|NCT00438399|143334628|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.||||<0.0001
71906150|NCT00723073|143334629|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|STANDARD_DEVIATION|1.0||0.96|TWO_SIDED|95.0|0.89|1.1|||Fisher Exact|||||1.10|0.89|0.96
71906151|NCT00723073|143334630|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.38|2.7|||Fisher Exact|||||2.70|0.38|>0.99
71906152|NCT00723073|143334631|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93|STANDARD_DEVIATION|1.0|>|0.99|TWO_SIDED|95.0|0.44|1.97|||Fisher Exact|||||1.97|0.44|>0.99
71906153|NCT00723073|143334632|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12|STANDARD_DEVIATION|1.0||0.48|TWO_SIDED|95.0|0.61|2.07|||Fisher Exact|||||2.07|0.61|0.48
71857620|NCT00307164|143229354|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.25
71857621|NCT00307164|143229356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.88
71857622|NCT00307164|143229357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.60
71857623|NCT00307164|143229358|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.13
71857624|NCT00307164|143229359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
71857625|NCT00307164|143229360|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.034
71857626|NCT00307164|143229361|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.76
71857627|NCT00307164|143229362|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.10
71857628|NCT00307164|143229363|SUPERIORITY_OR_OTHER_LEGACY|||||||0.43||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.43
71857629|NCT00307164|143229364|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.17
71857630|NCT00307164|143229365|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.80
71857631|NCT00307164|143229366|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42||95.0|||||Stratified Wilcoxon rank-sum test|||||||0.42
71857632|NCT02971228|143229421|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-6.9||||0.2518|TWO_SIDED|95.0|-19.63|5.84|||t-test, 2 sided||The estimated mean difference is based on the difference between the mean values for 10 patients in the ZP4207 group (12.78) and the matching 10 patients in the Lilly glucagon group (19.67)|A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||5.84|-19.63|0.2518
71906154|NCT00723073|143334633|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.57|STANDARD_DEVIATION|1.0||0.57|TWO_SIDED|95.0|0.1|3.37|||Fisher Exact|||||3.37|0.10|0.57
71906155|NCT00723073|143334634|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
71906156|NCT00723073|143334637|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Fisher Exact|||||||0.22
71906157|NCT00723073|143334638|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Fisher Exact|||||||0.11
71857633|NCT02971228|143229421|OTHER||Median Difference (Final Values)|-8.02||||0.25|TWO_SIDED|95.0|-25.85|10.68|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||10.68|-25.85|0.2500
71857634|NCT02971228|143229422|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|-0.28||||0.8508|TWO_SIDED|95.0|-3.55|2.99|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||2.99|-3.55|0.8508
71921967|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||9.7|-9.2|
71857635|NCT02971228|143229422|OTHER||Median Difference (Final Values)|0.03|||>|0.9999|TWO_SIDED|95.0|-4.12|3.13|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.13|-4.12|>0.9999
71857636|NCT02971228|143229423|OTHER|A paired t-test was used for the parametric method to compare patients receiving both treatments. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint. Thus, the 2 patients who withdrew from the trial after the Lilly Glucagon treatment before receiving ZP4207 were not included in the analysis.|Mean Difference (Final Values)|0.63||||0.1847|TWO_SIDED|95.0|-0.36|1.62|||t-test, 2 sided|||A paired t-test or the Wilcoxon signed rank test for comparison of means with normally or non normally distributed residuals, respectively, was used. The Shapiro-Wilk test was used to determine the normality of the residuals for each comparison. The residuals were obtained from an analysis of variance (ANOVA) model with treatment group as the fixed effect. If the p-value of the test was \<0.001, the non-parametric method was utilized to analyze the endpoint parameter.||1.62|-0.36|0.1847
71857637|NCT02971228|143229423|OTHER||Median Difference (Final Values)|0.02||||0.0781|TWO_SIDED|95.0|-0.01|3.09|||Wilcoxon (Mann-Whitney)|||Non-parametric method p-value was from a Wilcoxon signed rank text. The normality of the residuals was assessed using the Shapiro-Wilk test, where the residuals were obtained from an ANOVA model with treatment group as the fixed effect. A patient was required to have data for both periods to be included in the pre-specified analysis for a given endpoint.||3.09|-0.01|0.0781
71857638|NCT01193218|143229572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.57||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 5mg minus placebo||-0.57|-0.87|<0.0001
71857639|NCT01193218|143229572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 10mg minus placebo||-0.55|-0.85|<0.0001
71857640|NCT01193218|143229572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 25mg minus placebo||-0.80|-1.10|<0.0001
71857641|NCT01193218|143229572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|'treatment', 'renal function', and 'number of previous antidiabetic medication' as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 50mg minus placebo||-0.76|-1.06|<0.0001
71857642|NCT01193218|143229573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.367|||<|0.0001|TWO_SIDED|95.0|5.34|70.236|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo||70.236|5.340|<0.0001
71857643|NCT01193218|143229573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.889||||0.0003|TWO_SIDED|95.0|2.942|40.301|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.||Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo||40.301|2.942|0.0003
71857644|NCT01193218|143229573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.624|||<|0.0001|TWO_SIDED|95.0|7.601|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo||99.99|7.601|<0.0001
71857645|NCT01193218|143229573|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.906|||<|0.0001|TWO_SIDED|95.0|12.12|99.99|||Regression, Logistic|The model includes 'treatment', 'renal function', 'number of previous antidiabetic medications' and 'continuous baseline HbA1c'.|The upper limit of confidence interval is actually \>99.99|Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo||99.99|12.120|<0.0001
71857646|NCT01193218|143229574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.7|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-31.61|-21.8|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 5mg minus placebo||-21.80|-31.61|<0.0001
71857647|NCT01193218|143229574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.34|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-34.25|-24.42|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 10mg minus placebo||-24.42|-34.25|<0.0001
71857648|NCT01193218|143229574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.75|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-42.66|-32.84|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 25mg minus placebo||-32.84|-42.66|<0.0001
71921968|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-11.5|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||2.3|-11.5|
71921969|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-9.9|4.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||4.2|-9.9|
71857649|NCT01193218|143229574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.6|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-41.51|-31.69|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 50mg minus placebo||-31.69|-41.51|<0.0001
71857650|NCT01424189|143229583|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.013|||ONE_SIDED|95.0||0.03||||||||0.030||
71857651|NCT01424189|143229584|NON_INFERIORITY_OR_EQUIVALENCE|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|-0.044|STANDARD_ERROR_OF_MEAN|0.015|||ONE_SIDED|95.0||-0.017||||||||-0.017||
71857652|NCT01077622|143229617|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||SERC assessment|||93.3|34.8|
71857653|NCT01077622|143229617|SUPERIORITY_OR_OTHER||percentage of participants|70.0|||||TWO_SIDED|95.0|34.8|93.3|||||Investigator assessment|||93.3|34.8|
71857654|NCT01042145|143229660|SUPERIORITY_OR_OTHER|||||||0.34|||||||Fisher Exact|||||||0.34
71681200|NCT00772005|142881162|SUPERIORITY_OR_OTHER|||||||0.0625||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0625
71857655|NCT01042145|143229661|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.63
71857656|NCT01042145|143229663|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.51
71857657|NCT01042145|143229664|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.24
71857658|NCT01042145|143229665|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71857659|NCT01502371|143229700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.87||||0.019|TWO_SIDED|95.0|0.64|7.09||Constrained longitudinal data analysis (cLDA) model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. Placebo||7.09|0.64|0.019
71857660|NCT01502371|143229700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.29|||<|0.001|TWO_SIDED|95.0|3.05|9.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo||9.53|3.05|<0.001
71857661|NCT01502371|143229700|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.34||||0.001|TWO_SIDED|95.0|2.07|8.61||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo||8.61|2.07|0.001
71857662|NCT01502371|143229701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|19.15||||0.045|TWO_SIDED|95.0|0.43|37.87||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||37.87|0.43|0.045
71857663|NCT01502371|143229701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|27.35||||0.004|TWO_SIDED|95.0|8.63|46.08||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||46.08|8.63|0.004
71681201|NCT00772005|142881163|SUPERIORITY_OR_OTHER|||||||0.2981||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2981
71857664|NCT01502371|143229701|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|18.01||||0.057|TWO_SIDED|95.0|-0.51|36.53||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||36.53|-0.51|0.057
71857665|NCT01502371|143229702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.28|TWO_SIDED|95.0|-0.08|0.27||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.27|-0.08|0.280
71906158|NCT01179347|143334674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|0.97||0.092||95.0|-0.27|3.55||Two-sided p-value.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing procedure was applied for both co-primary endpoints to maintain the overall alpha level. If and only if statistical superiority of the Tio R5 qd compared to Placebo in FEV1 AUC0-4h was demonstrated at the 1 sided alpha level of 0.025, confirmatory comparison in the second co-primary endpoint, at the same alpha level of 0.025 could be done .||3.55|-0.27|0.092
71906159|NCT01179347|143334675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.97||0.15||95.0|-0.5|3.3||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful,||3.30|-0.50|0.15
71906160|NCT01179347|143334676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|0.9||0.23||95.0|-0.68|2.86||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||2.86|-0.68|0.23
71906161|NCT01179347|143334677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.93||0.19||95.0|-0.62|3.02||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||3.02|-0.62|0.19
71906162|NCT01179347|143334678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.76||0.62||95.0|-2.59|4.32||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|||4.32|-2.59|0.62
71906163|NCT01179347|143334679|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.092||||0.84||95.0|0.453|2.633||Two-sided p-value.|Regression, Logistic|Adjusted for treatment, age group, baseline weight and baseline FEV1 percent predicted.|Tio R5 qd versus Placebo.|||2.633|0.453|0.84
71906164|NCT01114373|143334789|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0269
71906165|NCT01114373|143334789|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||ANOVA|||||||0.84
71681202|NCT00772005|142881163|SUPERIORITY_OR_OTHER|||||||0.0104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0104
71681203|NCT00772005|142881163|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0150
71681204|NCT00772005|142881164|SUPERIORITY_OR_OTHER|||||||0.4608||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4608
71906166|NCT01114373|143334790|SUPERIORITY_OR_OTHER|||||||0.0492|TWO_SIDED||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.||||0.0492
71906167|NCT01114373|143334790|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
71906168|NCT01114373|143334791|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
71906169|NCT01114373|143334792|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||ANOVA|||||||0.88
71906170|NCT01114373|143334793|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||ANOVA|||||||0.16
71906171|NCT01114373|143334794|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
71906172|NCT01114373|143334795|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||ANOVA|||||||0.12
71906173|NCT01114373|143334796|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||ANOVA|||||||0.21
71906174|NCT01114373|143334797|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Friedman|||||||0.06
71906175|NCT01114373|143334798|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Friedman|||||||0.21
71906176|NCT01114373|143334799|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Friedman|||||||0.41
71906177|NCT01114373|143334800|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
71906178|NCT01114373|143334801|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
71906179|NCT01114373|143334802|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||ANOVA|||||||0.39
71906180|NCT00421603|143334859|NON_INFERIORITY_OR_EQUIVALENCE|All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.|||||=|0.05|||||||Chi-squared, Corrected|||The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).||||=.05
71906181|NCT03444870|143334862|SUPERIORITY||Difference in adjusted mean|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0954|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline Alzheimer Disease Assessment Scale-Cognition Subscale 13 (ADAS-Cog13) Score + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.05|-0.66|0.0954
71857666|NCT01502371|143229702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.178|TWO_SIDED|95.0|-0.06|0.3||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.30|-0.06|0.178
71857667|NCT01502371|143229702|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.18||||0.045|TWO_SIDED|95.0|0.0|0.36||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.||0.36|0.00|0.045
71857668|NCT01502371|143229703|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|1.39||||0.368|TWO_SIDED|95.0|-1.65|4.44||cLDA model method proposed by Liang \& Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction \& region (North America, Latin America \& the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. MF DPI 100 mcg QD. Only participants who received MF MDI 50 mcg BID or MF DPI 100 mcg QD were included in the statistical analysis.||4.44|-1.65|0.368
71857669|NCT02154347|143229704|SUPERIORITY||Mean Difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.95|-0.37|||t-test, 2 sided|||||-0.37|-0.95|<0.001
71857670|NCT02509312|143229841|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71857671|NCT02509312|143229842|SUPERIORITY|||||||0.257|||||||Chi-squared|||||||.257
71857672|NCT02509312|143229843|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
71857673|NCT02509312|143229844|SUPERIORITY|||||||0.164|||||||Wilcoxon (Mann-Whitney)|||||||0.164
71857674|NCT02509312|143229845|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71857675|NCT02509312|143229846|SUPERIORITY||Risk Difference (RD)|-0.27||||0.0367|TWO_SIDED|95.0|-0.52|-0.03|||Chi-squared|||||-0.03|-0.52|0.0367
71857676|NCT02509312|143229847|SUPERIORITY|||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||||||0.0231
71857677|NCT02509312|143229848|SUPERIORITY|||||||0.467|||||||Wilcoxon (Mann-Whitney)|||||||0.467
71857678|NCT02509312|143229849|SUPERIORITY|||||||0.273|||||||Wilcoxon (Mann-Whitney)|||||||0.273
71857679|NCT02509312|143229850|SUPERIORITY|||||||0.0162||||||p-value for 12 hours post-op between-group comparison.|t-test, 2 sided|||||||0.0162
71857680|NCT02509312|143229852|SUPERIORITY|||||||0.048||||||p-value for 6 hours post-op between-group comparison.|Wilcoxon (Mann-Whitney)|||||||0.048
71857681|NCT00702650|143229853|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||One-Sample Binomial (Wald) test, 2-sided|||||||<0.001
71857682|NCT00702650|143229858|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
71857683|NCT00702650|143229858|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
71857684|NCT00702650|143229858|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
71857685|NCT00702650|143229858|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
71857686|NCT00702650|143229858|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided|||||||<0.0001
71857687|NCT00702650|143229859|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||0.0254
71857688|NCT00702650|143229859|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided|||||||<0.0001
71857689|NCT03954223|143229868|SUPERIORITY|||||||0.4|TWO_SIDED|95.0|||||ANOVA|||||||0.4
71857690|NCT03954223|143229869|SUPERIORITY||Median Difference (Final Values)|-7.0||||0.2|TWO_SIDED|95.0|||||Regression, Linear|Mixed-effects generalized linear model of the glycemic profile change extracted from CGM data.||||||0.2
71857691|NCT01475461|143229880|SUPERIORITY_OR_OTHER||Least squares (LS) Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.172||0.5206|TWO_SIDED|80.0|-0.21|0.23||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.23|-0.21|0.5206
71857692|NCT01475461|143229880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.178||0.1645|TWO_SIDED|80.0|-0.4|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo||0.05|-0.40|0.1645
71857693|NCT01475461|143229880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.172||0.1592|TWO_SIDED|80.0|-0.39|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||0.05|-0.39|0.1592
71857694|NCT01475461|143229880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.174||0.0049|TWO_SIDED|80.0|-0.68|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.23|-0.68|0.0049
71857695|NCT01475461|143229880|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.173||0.0068|TWO_SIDED|80.0|-0.65|-0.21||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.||-0.21|-0.65|0.0068
71857696|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.097||0.3434|TWO_SIDED|80.0|-0.16|0.09||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.09|-0.16|0.3434
71857697|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.0892|TWO_SIDED|80.0|-0.27|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.27|0.0892
71857698|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.097||0.0826|TWO_SIDED|80.0|-0.26|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.01|-0.26|0.0826
71857699|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.098||0.0031|TWO_SIDED|80.0|-0.4|-0.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.15|-0.40|0.0031
71857700|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.098||0.0005|TWO_SIDED|80.0|-0.45|-0.2||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.20|-0.45|0.0005
71857701|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.5133|TWO_SIDED|80.0|-0.18|0.19||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.19|-0.18|0.5133
71857702|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.15||0.1873|TWO_SIDED|80.0|-0.33|0.06||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.06|-0.33|0.1873
71857703|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.145||0.212|TWO_SIDED|80.0|-0.3|0.07||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.07|-0.30|0.2120
71857704|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.146||0.0001|TWO_SIDED|80.0|-0.73|-0.35||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.||-0.35|-0.73|0.0001
71857705|NCT01475461|143229881|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.146||0.0021|TWO_SIDED|80.0|-0.61|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.23|-0.61|0.0021
71857706|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|4.823||0.724|TWO_SIDED|80.0|-3.32|9.07||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.07|-3.32|0.7240
71857707|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.77|STANDARD_ERROR_OF_MEAN|4.952||0.3608|TWO_SIDED|80.0|-8.13|4.59||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.59|-8.13|0.3608
71857708|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|4.816||0.2511|TWO_SIDED|80.0|-9.42|2.95||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.95|-9.42|0.2511
71857709|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.28|STANDARD_ERROR_OF_MEAN|4.851||0.0673|TWO_SIDED|80.0|-13.51|-1.05||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-1.05|-13.51|0.0673
71857710|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.22|STANDARD_ERROR_OF_MEAN|4.843||0.0106|TWO_SIDED|80.0|-17.44|-5.0||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-5.00|-17.44|0.0106
71857711|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|5.138||0.4127|TWO_SIDED|80.0|-7.73|5.47||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.47|-7.73|0.4127
71857712|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|5.261||0.3604|TWO_SIDED|80.0|-8.64|4.87||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.87|-8.64|0.3604
71857713|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.35|STANDARD_ERROR_OF_MEAN|5.147||0.077|TWO_SIDED|80.0|-13.96|-0.74||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.74|-13.96|0.0770
71857714|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.79|STANDARD_ERROR_OF_MEAN|5.171||0.0451|TWO_SIDED|80.0|-15.43|-2.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-2.15|-15.43|0.0451
71906182|NCT03444870|143334864|SUPERIORITY||Difference in adjusted mean|-1.25|STANDARD_ERROR_OF_MEAN|0.65||0.0544|TWO_SIDED|95.0|-2.52|0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.02|-2.52|0.0544
71906183|NCT03444870|143334865|SUPERIORITY||Difference in adjusted mean|1.11|STANDARD_ERROR_OF_MEAN|0.81||0.1729|TWO_SIDED|95.0|-0.48|2.7|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4.||2.70|-0.48|0.1729
71906184|NCT03444870|143334866|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.42||0.0425|TWO_SIDED|95.0|-1.68|-0.03|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.03|-1.68|0.0425
71681205|NCT00772005|142881164|SUPERIORITY_OR_OTHER|||||||0.0807||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0807
71857715|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.9|STANDARD_ERROR_OF_MEAN|5.191||0.0001|TWO_SIDED|80.0|-26.57|-13.23||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-13.23|-26.57|0.0001
71857716|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|1.11|STANDARD_ERROR_OF_MEAN|5.599||0.5783|TWO_SIDED|80.0|-6.08|8.3||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.30|-6.08|0.5783
71857717|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|5.785||0.3604|TWO_SIDED|80.0|-9.5|5.36||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||5.36|-9.50|0.3604
71906185|NCT03444870|143334867|SUPERIORITY||Difference in adjusted mean|0.32|STANDARD_ERROR_OF_MEAN|0.31||0.2904|TWO_SIDED|95.0|-0.28|0.93|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||0.93|-0.28|0.2904
71906186|NCT03444870|143334868|SUPERIORITY||Difference in adjusted mean|-0.97|STANDARD_ERROR_OF_MEAN|0.6||0.1036|TWO_SIDED|95.0|-2.14|0.2|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.20|-2.14|0.1036
71906187|NCT03444870|143334869|SUPERIORITY||Difference in adjusted mean|-0.07|STANDARD_ERROR_OF_MEAN|0.37||0.8468|TWO_SIDED|95.0|-0.79|0.65|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.65|-0.79|0.8468
71857718|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.12|STANDARD_ERROR_OF_MEAN|5.636||0.0161|TWO_SIDED|80.0|-19.36|-4.88||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-4.88|-19.36|0.0161
71857719|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|5.663||0.2185|TWO_SIDED|80.0|-11.68|2.87||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||2.87|-11.68|0.2185
71857720|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.41|STANDARD_ERROR_OF_MEAN|5.649||0.0034|TWO_SIDED|80.0|-22.67|-8.16||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-8.16|-22.67|0.0034
71857721|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|6.387||0.5727|TWO_SIDED|80.0|-7.03|9.37||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||9.37|-7.03|0.5727
71857722|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|6.578||0.4961|TWO_SIDED|80.0|-8.51|8.38||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.38|-8.51|0.4961
71857723|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|6.411||0.2616|TWO_SIDED|80.0|-12.33|4.14||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||4.14|-12.33|0.2616
71857724|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|9.06|STANDARD_ERROR_OF_MEAN|6.441||0.9197|TWO_SIDED|80.0|0.79|17.34||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||17.34|0.79|0.9197
71857725|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.76|STANDARD_ERROR_OF_MEAN|6.398||0.086|TWO_SIDED|80.0|-16.98|-0.54||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||-0.54|-16.98|0.0860
71906188|NCT03444870|143334870|SUPERIORITY||Difference in adjusted mean|0.2|STANDARD_ERROR_OF_MEAN|0.79||0.803|TWO_SIDED|95.0|-1.35|1.74|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||1.74|-1.35|0.8030
71906189|NCT03444870|143334871|SUPERIORITY||Difference in adjusted mean|1.0|STANDARD_ERROR_OF_MEAN|0.68||0.1439|TWO_SIDED|95.0|-0.34|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.34|-0.34|0.1439
71906190|NCT03444870|143334878|SUPERIORITY||Difference in adjusted means|-66.44|STANDARD_ERROR_OF_MEAN|4.171|<|0.0001|TWO_SIDED|95.0|-74.71|-58.16|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-58.16|-74.71|<.0001
71906191|NCT03444870|143334879|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
71857726|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|6.476||0.5132|TWO_SIDED|80.0|-8.1|8.53||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||8.53|-8.10|0.5132
71857727|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|2.68|STANDARD_ERROR_OF_MEAN|6.676||0.656|TWO_SIDED|80.0|-5.89|11.26||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||11.26|-5.89|0.6560
71906192|NCT03444870|143334879|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
71906193|NCT03444870|143334879|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
71906194|NCT03444870|143334879|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
71906195|NCT03444870|143334880|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||||<.001
71906196|NCT03444870|143334881|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
71857728|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|6.17|STANDARD_ERROR_OF_MEAN|6.496||0.8285|TWO_SIDED|80.0|-2.17|14.52||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||14.52|-2.17|0.8285
71857729|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|15.98|STANDARD_ERROR_OF_MEAN|6.527||0.9925|TWO_SIDED|80.0|7.59|24.36||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||24.36|7.59|0.9925
71857730|NCT01475461|143229882|SUPERIORITY_OR_OTHER||LS Mean Difference|1.66|STANDARD_ERROR_OF_MEAN|6.487||0.601|TWO_SIDED|80.0|-6.67|10.0||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||10.00|-6.67|0.6010
71857731|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|0.449||0.0913|TWO_SIDED|80.0|0.18|1.34||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.34|0.18|0.0913
71857732|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.461||0.5236|TWO_SIDED|80.0|-0.3|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.30|0.5236
71857733|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.447||0.9244|TWO_SIDED|80.0|-0.53|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.62|-0.53|0.9244
71857734|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.452||0.5066|TWO_SIDED|80.0|-0.28|0.88||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.88|-0.28|0.5066
71857735|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.449||0.8947|TWO_SIDED|80.0|-0.64|0.52||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.52|-0.64|0.8947
71857736|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.478||0.0577|TWO_SIDED|80.0|0.3|1.52||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.52|0.30|0.0577
71857737|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.49||0.3012|TWO_SIDED|80.0|-0.12|1.14||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.14|-0.12|0.3012
71857738|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.476||0.3165|TWO_SIDED|80.0|-0.13|1.09||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.09|-0.13|0.3165
71906197|NCT03444870|143334882|SUPERIORITY|||||||0.396|||||||ANCOVA|||||||0.396
71906198|NCT03444870|143334883|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<.001
71906199|NCT01205451|143334906|SUPERIORITY_OR_OTHER||t-distribution|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.38|-1.04||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.04|-1.38|<0.0001
71906200|NCT01205451|143334906|SUPERIORITY_OR_OTHER||t-distribution|-1.33|||<|0.0001|TWO_SIDED|95.0|-1.54|-1.12||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-1.12|-1.54|<0.0001
71906201|NCT01205451|143334906|SUPERIORITY_OR_OTHER||t-distribution|-0.88|||<|0.0001|TWO_SIDED|95.0|-1.04|-0.72||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.72|-1.04|<0.0001
71906202|NCT01205451|143334906|SUPERIORITY_OR_OTHER||t-distribution|-1.12|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.91||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.|||-0.91|-1.33|<0.0001
71857739|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.481||0.5191|TWO_SIDED|80.0|-0.31|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.31|0.5191
71857740|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.479||0.5107|TWO_SIDED|80.0|-0.3|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.30|0.5107
71857741|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.79|STANDARD_ERROR_OF_MEAN|0.488||0.1054|TWO_SIDED|80.0|0.17|1.42||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.42|0.17|0.1054
71857742|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.502||0.5341|TWO_SIDED|80.0|-0.33|0.96||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.96|-0.33|0.5341
71857743|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.487||0.2782|TWO_SIDED|80.0|-0.1|1.15||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.15|-0.10|0.2782
71857744|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.492||0.5331|TWO_SIDED|80.0|-0.32|0.94||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.94|-0.32|0.5331
71857745|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.489||0.907|TWO_SIDED|80.0|-0.57|0.68||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.68|-0.57|0.9070
71906203|NCT03004469|143334944|OTHER||LS Mean Difference|13.6|STANDARD_ERROR_OF_MEAN|3.94|<|0.001|TWO_SIDED|95.0|5.8|21.3|||Mixed linear model|||||21.3|5.8|<.001
71906204|NCT03004469|143334945|OTHER||LS Mean Difference|12.8|STANDARD_ERROR_OF_MEAN|3.19|<|0.001|TWO_SIDED|95.0|6.5|19.1|||Mixed linear model|||||19.1|6.5|<.001
71857746|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.512||0.1757|TWO_SIDED|80.0|0.04|1.35||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.35|0.04|0.1757
71857747|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.527||0.4083|TWO_SIDED|80.0|-0.24|1.11||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.11|-0.24|0.4083
71857748|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|0.511||0.315|TWO_SIDED|80.0|-0.14|1.17||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.17|-0.14|0.3150
71857749|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.516||0.6631|TWO_SIDED|80.0|-0.44|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.89|-0.44|0.6631
71857750|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.512||0.8694|TWO_SIDED|80.0|-0.74|0.57||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.57|-0.74|0.8694
71906205|NCT03004469|143334946|OTHER||LS Mean Difference|-0.4024|STANDARD_ERROR_OF_MEAN|0.4057||0.322|TWO_SIDED|95.0|-1.202|0.3971|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3971|-1.2020|0.322
71906206|NCT03004469|143334946|OTHER||LS Mean Difference|0.7237|STANDARD_ERROR_OF_MEAN|0.47799||0.131|TWO_SIDED|95.0|-0.2184|1.6657|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||1.6657|-0.2184|0.131
71906207|NCT03004469|143334947|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.569|TWO_SIDED|95.0|-0.3|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.2|-0.3|0.569
71906208|NCT03004469|143334947|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.129|TWO_SIDED|95.0|-0.4|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.1|-0.4|0.129
71906209|NCT03004469|143334948|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.708|TWO_SIDED|95.0|-0.2|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.3|-0.2|0.708
71906210|NCT03004469|143334948|OTHER||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|0.2|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.7|0.2|<.001
71906211|NCT03004469|143334949|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.179|TWO_SIDED|95.0|-0.3|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 12||0.1|-0.3|0.179
71681206|NCT00772005|142881164|SUPERIORITY_OR_OTHER|||||||0.2959||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2959
71857751|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|0.545||0.2031|TWO_SIDED|80.0|0.0|1.4||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||1.40|0.00|0.2031
71857752|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.563||0.7137|TWO_SIDED|80.0|-0.52|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.93|-0.52|0.7137
71857753|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.545||0.681|TWO_SIDED|80.0|-0.48|0.92||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.92|-0.48|0.6810
71857754|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.55||0.6921|TWO_SIDED|80.0|-0.92|0.49||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.49|-0.92|0.6921
71857755|NCT01475461|143229889|SUPERIORITY_OR_OTHER||LS Mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.545||0.3702|TWO_SIDED|80.0|-1.19|0.21||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.||0.21|-1.19|0.3702
71857756|NCT03214250|143229914|SUPERIORITY|One-sided|probability|0.577||||0.006|ONE_SIDED|95.0|0.417|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.417|0.006
71857757|NCT03214250|143229914|SUPERIORITY|One-sided|probability|0.481||||0.062|ONE_SIDED|95.0|0.337|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.337|0.062
71857758|NCT03214250|143229914|SUPERIORITY|One-sided|probability|0.413||||0.233|ONE_SIDED|95.0|0.27|||one-sided p-value|z-test|One-sided, one-sample z-test of the Kaplan-Meier estimate of the 1-year OS rate (and its standard error) against the historical rate of 35%||Each treatment arm was analyzed independently and compared to a historical 1-year OS reference rate of 35%.|||0.270|0.233
71857759|NCT00594178|143229926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-250.8||||0.318|TWO_SIDED|95.0|-778.87|277.21|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.||277.21|-778.87|.318
71857760|NCT00594178|143229927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0645||||0.011|TWO_SIDED|95.0|0.01827|0.11073|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.||.11073|.01827|.011
71857761|NCT00496626|143229928|SUPERIORITY_OR_OTHER||GMT ratio|101.6|||<=|0.05|TWO_SIDED|95.0|88.1|117.2||The ANCOVA models showed the lower bounds of two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] were greater than 1 for each HPV type, so the null hypothesis was rejected. The CI reported is for HPV18, the type with the smallest CI lower bound.|ANCOVA||Superiority of GARDASIL™ to placebo was claimed if, for each of the four HPV types, the lower bound of the two-sided 95% CI on the GMT ratio \[GARDASIL™/placebo\] being \>1, or equivalently, the two-sided p-value \<0.05.|An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.||117.2|88.1|<=0.05
71857762|NCT00496626|143229929|SUPERIORITY_OR_OTHER||Seroconversion Rate|96.65|||<=|0.05||95.0|93.74|98.46||The lower bound of the 95% CI for the seroconversion rate was greater than 90% for each type so the null hypothesis was rejected. The CI reported is for HPV6, the type with the smallest lower bound.|Exact Binomial CI|||The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.||98.46|93.74|<=0.05
71681207|NCT00772005|142881165|SUPERIORITY_OR_OTHER|||||||0.6759||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6759
71857763|NCT02005393|143229937|NON_INFERIORITY_OR_EQUIVALENCE|Image settings were considered non-inferior if scores overlapped within 1 SD of mean.||||||||||||||||All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).|The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.|||
71857764|NCT00241969|143229943|SUPERIORITY|Some data were missing for energy intake (n=3 baseline, n=13 post-treatment), thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measure factor.|maximum likelihood estimation|431.0|||<|0.001|TWO_SIDED|95.0|282.0|581.0|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Some data were missing for energy intake (N = 3 baseline; 13 post treatment), and thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measures factor, no group main effect at baseline for energy intake, and sex, baseline Pseudomonas aeruginosa status, and treatment modality as covariates in the statistical model. This model is similar to an analysis of covariance model with baseline energy intake included as an additional covariate, but the PROC MIXED model employs maximum likelihood estimation and consequently allows for data to be missing at random. The test of the time by group interaction within this PROC MIXED model indicated whether the behavioral and nutrition treatment was efficacious relative to our control treatment.|581|282|<0.001
71857765|NCT00241969|143229944|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.09||||0.25|TWO_SIDED|95.0|-0.06|0.24|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.24|-0.06|0.25
71857766|NCT00241969|143229945|SUPERIORITY|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.14||||0.049|TWO_SIDED|95.0|0.001|0.27|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ and HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.|0.27|0.001|0.049
71857767|NCT01013740|143229968|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||||95.0|0.53|1.35|||||The Pike estimator of the treatment HR was based on the log rank test.|||1.35|0.53|
71857768|NCT01013740|143229973|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|0.63|3.58||||||||3.58|0.63|
71857769|NCT00338949|143229977|SUPERIORITY_OR_OTHER_LEGACY|||||||0.228|||||||t-test, 2 sided|||||||0.228
71857770|NCT00338949|143229978|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|||||||t-test, 2 sided|||||||0.958
71906212|NCT03004469|143334949|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.262|TWO_SIDED|95.0|-0.1|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Week 24||0.4|-0.1|0.262
71906213|NCT03004469|143334950|OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|1.03||0.103|TWO_SIDED|95.0|-3.7|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 4||0.3|-3.7|0.103
71906214|NCT03004469|143334950|OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.1||0.545|TWO_SIDED|95.0|-2.8|1.5|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 8||1.5|-2.8|0.545
71906215|NCT03004469|143334950|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|1.0||0.842|TWO_SIDED|95.0|-2.2|1.8|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 12||1.8|-2.2|0.842
71906216|NCT03004469|143334950|OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.02||0.449|TWO_SIDED|95.0|-2.8|1.2|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 24||1.2|-2.8|0.449
71906217|NCT03004469|143334950|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.28||0.272|TWO_SIDED|95.0|-0.2|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 4||0.9|-0.2|0.272
71906218|NCT03004469|143334950|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.36||0.918|TWO_SIDED|95.0|-0.7|0.8|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 8||0.8|-0.7|0.918
71906219|NCT03004469|143334950|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.078||0.078|TWO_SIDED|95.0|-0.1|1.1|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 12||1.1|-0.1|0.078
71906220|NCT03004469|143334950|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.34||0.593|TWO_SIDED|95.0|-0.9|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 24||0.5|-0.9|0.593
71906221|NCT03004469|143334950|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.295|TWO_SIDED|95.0|-0.7|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 4||0.2|-0.7|0.295
71857771|NCT00582114|143229988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.36||||0.001|TWO_SIDED|95.0|1.36|4.23|||Mixed Models Analysis|||Cardiovascular events were counted by subject and included the following: myocardial infarction, stroke, hospitalization for congestive heart failure, hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||4.23|1.36|0.001
71857772|NCT00582114|143229988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.29||||0.02|TWO_SIDED|95.0|1.07|5.21|||Mixed Models Analysis|||As a post hoc analysis, we determined the narrower definition of cardiovascular events per group that included myocardial infarction, stroke, congestive heart failure or cardiovascular death. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).||5.21|1.07|0.02
71857773|NCT00582114|143229988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.13||||0.02|TWO_SIDED|95.0|1.08|10.99|||Mixed Models Analysis|||Hospitalization for congestive heart failure between groups was analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||10.99|1.08|0.02
71857774|NCT00582114|143229988|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.61||||0.002|TWO_SIDED|95.0|1.18|2.19|||Mixed Models Analysis|||All-cause hospitalizations between groups were analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.||2.19|1.18|0.002
71857775|NCT02604342|143229989|SUPERIORITY||Hazard Ratio (HR)|0.2|||<|0.001|TWO_SIDED|95.0|0.12|0.33|||Stratified log-rank test||Estimated hazard ratio obtained from stratified Cox model with treatment group as covariate.|||0.33|0.12|<0.001
71857776|NCT02604342|143229990|SUPERIORITY||Difference in C-ORR|0.667|||<|0.001|TWO_SIDED|95.0|0.39|0.86|||Chi-squared|||95% confidence interval of the difference (alectinib - chemotherapy) computed using Hauck-Anderson approach.||0.86|0.39|<0.001
71857777|NCT02024750|143230013|OTHER||Mean Difference (Net)|0.005||||0.72|TWO_SIDED|95.0|-0.021|0.03||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.030|-0.021|0.72
71857778|NCT02024750|143230013|OTHER||Mean Difference (Net)|-0.01||||0.38|TWO_SIDED|95.0|-0.034|0.013||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.||0.013|-0.034|0.38
71857779|NCT02024750|143230014|OTHER||Mean Difference (Net)|0.023||||0.87|TWO_SIDED|95.0|-0.249|0.295||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.295|-0.249|0.87
71906222|NCT03004469|143334950|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.926|TWO_SIDED|95.0|-0.5|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 8||0.4|-0.5|0.926
71906223|NCT03004469|143334950|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.183|TWO_SIDED|95.0|-0.7|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 12||0.1|-0.7|0.183
71857780|NCT02024750|143230014|OTHER||Mean Difference (Net)|-0.074||||0.74|TWO_SIDED|95.0|-0.517|0.369||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.369|-0.517|0.74
71906224|NCT03004469|143334950|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.981|TWO_SIDED|95.0|-0.4|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 24||0.5|-0.4|0.981
71857781|NCT02024750|143230015|OTHER||Mean Difference (Net)|-0.037||||0.79|TWO_SIDED|95.0|-0.312|0.237||The a priori threshold for statistical significance was p\<0.05|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.237|-0.312|0.79
71857782|NCT02024750|143230015|OTHER||Mean Difference (Net)|-0.009||||0.97|TWO_SIDED|95.0|-0.467|0.448||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.||0.448|-0.467|0.97
71906225|NCT03004469|143334950|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.66||0.041|TWO_SIDED|95.0|-2.7|-0.1|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4||-0.1|-2.7|0.041
71906226|NCT03004469|143334950|OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.67||0.562|TWO_SIDED|95.0|-1.7|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8||0.9|-1.7|0.562
71906227|NCT03004469|143334950|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.66||0.642|TWO_SIDED|95.0|-1.6|1.0|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12||1.0|-1.6|0.642
71681208|NCT00772005|142881165|SUPERIORITY_OR_OTHER|||||||0.2418||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2418
71681209|NCT00772005|142881165|SUPERIORITY_OR_OTHER|||||||0.9808||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9808
71681210|NCT00772005|142881166|SUPERIORITY_OR_OTHER|||||||0.7599||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7599
71681211|NCT00772005|142881166|SUPERIORITY_OR_OTHER|||||||0.4543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4543
71681212|NCT00772005|142881166|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6040
71857783|NCT02024750|143230016|OTHER||Mean Difference (Net)|0.134||||0.3|TWO_SIDED|95.0|-0.121|0.388||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.388|-0.121|0.30
71857784|NCT02024750|143230016|OTHER||Mean Difference (Net)|-0.006||||0.98|TWO_SIDED|95.0|-0.384|0.373||The a priori threshold for statistical significance was p\<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.||0.373|-0.384|0.98
71857785|NCT00130728|143230017|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.7583||95.0|0.799|1.177||relative to placebo arm|Log Rank||Stratified analysis; Hazard ratio is relative to placebo arm.|||1.177|0.799|0.7583
71857786|NCT00130728|143230018|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.623|||<|0.0001||95.0|0.519|0.748||relative to placebo arm|Log Rank||Stratified analysis; hazard ratio is relative to placebo arm.|||0.748|0.519|<.0001
71857787|NCT00130728|143230019|SUPERIORITY_OR_OTHER_LEGACY||Percentage difference|6.4||||0.0068||95.0|1.8|11.3||Relative to placebo arm|Mantel Haenszel||Difference in objective response rates relative to placebo arm|||11.3|1.8|0.0068
71857788|NCT00746356|143230028|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0066|STANDARD_DEVIATION|0.3103|<|0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|<0.0001
71681213|NCT00772005|142881167|SUPERIORITY_OR_OTHER|||||||0.2476||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2476
71857789|NCT00746356|143230029|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0625|STANDARD_DEVIATION|0.0948||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
71906228|NCT03004469|143334950|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.65||0.156|TWO_SIDED|95.0|-2.2|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24||0.4|-2.2|0.156
71681214|NCT00772005|142881167|SUPERIORITY_OR_OTHER|||||||0.949||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9490
71681215|NCT00772005|142881167|SUPERIORITY_OR_OTHER|||||||0.9035||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9035
71681216|NCT00772005|142881168|SUPERIORITY_OR_OTHER|||||||0.9472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9472
71681217|NCT00772005|142881168|SUPERIORITY_OR_OTHER|||||||0.8335||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8335
71906229|NCT03004469|143334950|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.29||0.824|TWO_SIDED|95.0|-0.6|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4||0.5|-0.6|0.824
71906230|NCT03004469|143334950|OTHER||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.29||0.713|TWO_SIDED|95.0|-0.5|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8||0.7|-0.5|0.713
71857790|NCT00746356|143230030|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0556|STANDARD_DEVIATION|0.0824||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
71857791|NCT00746356|143230031|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0028|STANDARD_DEVIATION|0.2852||0.0001|ONE_SIDED|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was \<0.25 volts.|||-0.25|0.0001
71857792|NCT01125566|143230044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.4224||95.0|0.87|1.41||Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|||1.41|0.87|0.4224
71857793|NCT01125566|143230045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.024|TWO_SIDED|95.0|1.03|1.63||Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.63|1.03|0.0240
71857794|NCT01125566|143230046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6431||95.0|0.756|1.572|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.572|0.756|0.6431
71857795|NCT01125566|143230047|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.029||||0.8829||95.0|0.707|1.496|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)||1.496|0.707|0.8829
71906231|NCT03004469|143334950|OTHER||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.993|TWO_SIDED|95.0|-0.6|0.6|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12||0.6|-0.6|0.993
71906232|NCT03004469|143334950|OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.55|TWO_SIDED|95.0|-0.8|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24||0.4|-0.8|0.550
71857796|NCT03181282|143230056|SUPERIORITY||Slope|0.0529|STANDARD_ERROR_OF_MEAN|0.0194||0.0194|TWO_SIDED|95.0|0.0132|0.0925|||Mixed Models Analysis|Mixed model analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.0925|0.0132|0.0194
71857797|NCT03181282|143230056|SUPERIORITY||Slope|0.0718|STANDARD_ERROR_OF_MEAN|0.0231||0.004625|TWO_SIDED|95.0|0.0242|0.1194|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation Condition. Age was controlled for in the analysis given the baseline difference in age between groups.||0.1194|0.0242|0.004625
71857798|NCT03181282|143230057|SUPERIORITY||Slope|10.5248|STANDARD_ERROR_OF_MEAN|4.8439||0.038389|TWO_SIDED|95.0|0.6038|20.4459|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the On Medication / On Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||20.4459|0.6038|0.038389
71857799|NCT03181282|143230057|SUPERIORITY||Slope|7.7233|STANDARD_ERROR_OF_MEAN|4.668||0.109873|TWO_SIDED|95.0|-1.8652|17.3117|||Mixed Models Analysis|Mixed models analysis with repeated measures.||This analysis is for the Off Medication / Off Stimulation condition. Age was controlled for in the analysis given the baseline difference in age between groups.||17.3117|-1.8652|0.109873
71857800|NCT02484547|143230077|SUPERIORITY||Difference|-0.26||||0.0901|TWO_SIDED|95.0|-0.569|0.041|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.041|-0.569|0.0901
71857801|NCT02484547|143230077|SUPERIORITY||Difference|-0.39||||0.012|TWO_SIDED|95.0|-0.694|-0.086|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit.||-0.086|-0.694|0.0120
71906233|NCT04724733|143334966|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71906234|NCT04724733|143334966|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71906235|NCT04724733|143334966|SUPERIORITY|||||||0.0172|||||||t-test, 1 sided|||||||0.0172
71906236|NCT04724733|143334967|SUPERIORITY|||||||0.032|||||||t-test, 1 sided|||||||.0320
71906237|NCT04724733|143334967|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|||||||>0.05
71906238|NCT04724733|143334967|SUPERIORITY|||||||0.0008|||||||t-test, 1 sided|||||||0.0008
71906239|NCT04511819|143334968|OTHER||Risk Difference (RD)|-0.087||||0.8762|TWO_SIDED|95.0|-0.347|0.174|||Regression, Logistic|||||0.174|-0.347|0.8762
71857802|NCT02484547|143230078|SUPERIORITY||Difference|-0.1||||0.7578|TWO_SIDED|95.0|-0.65|0.48|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.48|-0.65|0.7578
71857803|NCT02484547|143230078|SUPERIORITY||Difference|0.6||||0.0493|TWO_SIDED|95.0|0.0|1.13|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.13|0.00|0.0493
71857804|NCT02484547|143230079|SUPERIORITY||Difference|-0.701||||0.1962|TWO_SIDED|95.0|-1.7649|0.3627|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||0.3627|-1.7649|0.1962
71857805|NCT02484547|143230079|SUPERIORITY||Difference|-1.4||||0.0097|TWO_SIDED|95.0|-2.4596|-0.3396|||MMRM|||Adjusted mean for each treatment group(Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADASCog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region, and laboratory ApoE status.||-0.3396|-2.4596|0.0097
71857806|NCT02484547|143230080|SUPERIORITY||Difference|0.7||||0.1515|TWO_SIDED|95.0|-0.27|1.73|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||1.73|-0.27|0.1515
71857807|NCT02484547|143230080|SUPERIORITY||Difference|1.7||||0.0006|TWO_SIDED|95.0|0.75|2.74|||MMRM|||Adjusted mean for each treatment group (Placebo, BIIB037 Low dose and BIIB037 High Dose), difference from Placebo,95% CI and p-value at each time point were based on an MMRM model, with change from baseline in ADCSADL-MCI as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||2.74|0.75|0.0006
71857808|NCT00953199|143230129|SUPERIORITY_OR_OTHER|||||||0.45||||||.05 was set as level of significance|Chi-squared|||We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.||||.45
71857809|NCT03151551|143230159|SUPERIORITY||Rate Difference|8.1||||0.036|TWO_SIDED|95.0|0.5|15.8|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||15.8|0.5|0.036
71857810|NCT03151551|143230160|NON_INFERIORITY|If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.|Rate Difference|3.9|||||TWO_SIDED|95.0|-4.3|12.1||||||||12.1|-4.3|
71857811|NCT03151551|143230161|SUPERIORITY||Rate Difference|13.4||||0.001|TWO_SIDED|95.0|5.3|21.6|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 24.||21.6|5.3|0.001
71857812|NCT03151551|143230162|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.725||0.155|TWO_SIDED|95.0|-2.46|0.39|||Mixed Models Analysis|||||0.39|-2.46|0.155
71857813|NCT03151551|143230163|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.249||0.823|TWO_SIDED|95.0|-0.54|0.43|||Mixed Models Analysis|||||0.43|-0.54|0.823
71857814|NCT03151551|143230164|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|2.104||0.752|TWO_SIDED|95.0|-4.8|3.47|||Mixed Models Analysis|||||3.47|-4.80|0.752
71906240|NCT01940510|143334979|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|26.8|||||TWO_SIDED|90.0|23.8|30.1|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.||30.1|23.8|
71857815|NCT03151551|143230165|SUPERIORITY||Mean Difference (Final Values)|-2.79|STANDARD_ERROR_OF_MEAN|2.06||0.177|TWO_SIDED|95.0|-6.83|1.26|||Mixed Models Analysis|||||1.26|-6.83|0.177
71857816|NCT03151551|143230166|SUPERIORITY||Mean Difference (Final Values)|-1.35|STANDARD_ERROR_OF_MEAN|1.391||0.332|TWO_SIDED|95.0|-4.08|1.38|||Mixed Models Analysis|||||1.38|-4.08|0.332
71857817|NCT03151551|143230167|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.599||0.592|TWO_SIDED|95.0|-0.86|1.5|||Mixed Models Analysis|||||1.50|-0.86|0.592
71857818|NCT03151551|143230168|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.045||0.176|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|||||0.03|-0.15|0.176
71857819|NCT03151551|143230169|SUPERIORITY||Rate Difference|13.1|||<|0.001|TWO_SIDED|95.0|5.4|20.7|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 \& BSA≥3% were considered PASI100 responders if, and only if, PASI=0 \& BSA=0 achieved at week 52.||20.7|5.4|<0.001
71857820|NCT03151551|143230170|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.091||0.368|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|0.368
71857821|NCT03151551|143230171|SUPERIORITY||Rate Difference|6.4||||0.108|TWO_SIDED|95.0|-1.8|14.5|||Regression, Logistic|||MDA-18 Entheseal Points||14.5|-1.8|0.108
71857822|NCT03151551|143230171|SUPERIORITY||Rate Difference|5.3||||0.179|TWO_SIDED|95.0|-2.9|13.5|||Regression, Logistic|||MDA-6 Entheseal Points||13.5|-2.9|0.179
71857823|NCT03151551|143230172|SUPERIORITY||Rate Difference|-1.1||||0.846|TWO_SIDED|95.0|-8.9|6.7|||Regression, Logistic|||||6.7|-8.9|0.846
71857824|NCT03151551|143230173|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.17||0.004|TWO_SIDED|95.0|-0.83|-0.16|||Mixed Models Analysis|||||-0.16|-0.83|0.004
71857825|NCT03151551|143230174|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.305||0.687|TWO_SIDED|95.0|-0.48|0.72|||Mixed Models Analysis|||||0.72|-0.48|0.687
71857826|NCT03151551|143230175|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.144||0.507|TWO_SIDED|95.0|-0.19|0.38|||Mixed Models Analysis|||||0.38|-0.19|0.507
71857827|NCT03151551|143230176|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|14.951||0.82|TWO_SIDED|95.0|-32.78|25.99|||Mixed Models Analysis|||||25.99|-32.78|0.820
71857828|NCT03151551|143230177|SUPERIORITY||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.79||0.052|TWO_SIDED|95.0|-3.09|0.02|||Mixed Models Analysis|||||0.02|-3.09|0.052
71857829|NCT03151551|143230178|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.949||0.005|TWO_SIDED|95.0|-4.57|-0.84|||Mixed Models Analysis|||||-0.84|-4.57|0.005
71857830|NCT03151551|143230179|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.202||0.158|TWO_SIDED|95.0|-0.68|0.11|||Mixed Models Analysis|||||0.11|-0.68|0.158
71857831|NCT03151551|143230180|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.711|TWO_SIDED|95.0|-0.49|0.33|||Mixed Models Analysis|||||0.33|-0.49|0.711
71857832|NCT03151551|143230181|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.674||0.439|TWO_SIDED|95.0|-0.8|1.85|||Mixed Models Analysis|||||1.85|-0.80|0.439
71857833|NCT03151551|143230182|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.86||0.594|TWO_SIDED|95.0|-1.23|2.15|||Mixed Models Analysis|||||2.15|-1.23|0.594
71857834|NCT03151551|143230183|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.017||0.979|TWO_SIDED|95.0|-0.03|0.03|||Mixed Models Analysis|||||0.03|-0.03|0.979
71857835|NCT03151551|143230184|SUPERIORITY||Mean Difference (Final Values)|4.78|STANDARD_ERROR_OF_MEAN|1.782||0.008|TWO_SIDED|95.0|1.28|8.28|||Mixed Models Analysis|||||8.28|1.28|0.008
71857836|NCT03151551|143230185|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.335|<|0.001|TWO_SIDED|95.0|-1.78|-0.46|||Mixed Models Analysis|||||-0.46|-1.78|<0.001
71857837|NCT03151551|143230186|SUPERIORITY||Rate Difference|5.7||||0.165|TWO_SIDED|95.0|-2.4|13.7|||Regression, Logistic|||Effectiveness of Medication||13.7|-2.4|0.165
71857838|NCT03151551|143230186|SUPERIORITY||Rate Difference|6.7||||0.098|TWO_SIDED|95.0|-1.4|14.8|||Regression, Logistic|||Effectiveness over Time of Medication||14.8|-1.4|0.098
71857839|NCT03151551|143230186|SUPERIORITY||Rate Difference|4.6||||0.241|TWO_SIDED|95.0|-3.4|12.6|||Regression, Logistic|||Long Term Safety of Medication||12.6|-3.4|0.241
71857840|NCT03151551|143230186|SUPERIORITY||Rate Difference|4.9||||0.215|TWO_SIDED|95.0|-3.1|13.0|||Regression, Logistic|||Overall Satisfaction with Medication||13.0|-3.1|0.215
71857841|NCT03151551|143230186|SUPERIORITY||Rate Difference|2.1||||0.561|TWO_SIDED|95.0|-5.5|9.7|||Regression, Logistic|||Mostly Satisfied to any Questions||9.7|-5.5|0.561
71857842|NCT03282799|143230202|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
71857843|NCT03282799|143230203|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
71857844|NCT03282799|143230204|OTHER||||||<|0.001|||||||Fisher Exact|||||||<.001
71857845|NCT03282799|143230205|OTHER||||||>|0.99|||||||Fisher Exact|||||||>.99
71857846|NCT03282799|143230206|OTHER|||||||0.685|||||||Wilcoxon (Mann-Whitney)|||||||.685
71857847|NCT03282799|143230207|OTHER|||||||0.784|||||||Wilcoxon (Mann-Whitney)|||||||.784
71857848|NCT03282799|143230208|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||||||.587
71857849|NCT03282799|143230209|OTHER|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||||||.394
71857850|NCT03282799|143230210|OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||.660
71857851|NCT03282799|143230211|OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.290
71857852|NCT00143598|143230248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.58|TWO_SIDED|95.0|0.73|1.76|||Regression, Cox|Adjusted for centre||||1.76|.73|.58
71857853|NCT04260464|143230272|OTHER||Test/Reference Ratio|110.15|||||TWO_SIDED|95.0|83.76|144.86||||||Analysis of variance (ANOVA) was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||144.86|83.76|
71857854|NCT04260464|143230272|OTHER||Test/Reference Ratio|94.58|||||TWO_SIDED|90.0|55.84|160.19||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||160.19|55.84|
71857855|NCT04260464|143230272|OTHER||Test/Reference Ratio|124.2|||||TWO_SIDED|90.0|100.24|153.89||||||ANOVA was used to compare the natural log transformed Cmax for PF-06700841 between the normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||153.89|100.24|
71906241|NCT01940510|143334980|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|48.6|||||TWO_SIDED|90.0|43.5|54.3|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||54.3|43.5|
71906242|NCT01940510|143334981|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|179.0|||||TWO_SIDED|90.0|158.0|202.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||202|158|
71906243|NCT01940510|143334982|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|220.0|||||TWO_SIDED|90.0|190.0|255.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.|||255|190|
71906244|NCT00084929|143334993|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.933||||||Accuracy: ROC analysis Receiver-operating-characteristic (ROC) curves were estimated with the use of data pooled from the radiologists because of the small number of positive cases reviewed by each radiologist.||0.933|0.853|
71906245|NCT00084929|143334993|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.838|0.96|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|"Sensitivity, for each radiologist, was calculated as the percentage of patients with lesions that were larger than or equal to the prespecified threshold and that were detected on both colonoscopy and CT colonography.~The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated."||0.96|0.838|
71921970|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-9.3|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-15.5|-3.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-3.0|-15.5|
71857856|NCT04260464|143230273|OTHER||Test/Reference Ratio|112.08|||||TWO_SIDED|95.0|60.85|206.45||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||206.45|60.85|
71921971|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-8.3|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-14.6|-1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||-1.9|-14.6|
71921972|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-12.6|2.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||2.0|-12.6|
71857857|NCT04260464|143230273|OTHER||Test/Reference Ratio|70.97|||||TWO_SIDED|90.0|27.6|182.49||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||182.49|27.60|
71921973|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.7|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||6.1|-8.7|
71921974|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-8.2|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||6.7|-8.2|
71921975|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.3|7.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||7.9|-7.3|
71857858|NCT04260464|143230273|OTHER||Test/Reference Ratio|147.7|||||TWO_SIDED|90.0|75.17|290.21||||||ANOVA was used to compare the natural log transformed AUCinf for PF-06700841 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||290.21|75.17|
71857859|NCT04260464|143230274|OTHER||Test/Reference Ratio|177.53|||||TWO_SIDED|95.0|135.82|232.04||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||232.04|135.82|
71857860|NCT04260464|143230274|OTHER||Test/Reference Ratio|132.69|||||TWO_SIDED|90.0|95.08|185.17||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.17|95.08|
71857861|NCT04260464|143230274|OTHER||Test/Reference Ratio|122.04|||||TWO_SIDED|90.0|84.47|176.3||||||ANOVA was used to compare the natural log transformed Cmax for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||176.30|84.47|
71857862|NCT04260464|143230275|OTHER||Test/Reference Ratio|445.99|||||TWO_SIDED|95.0|326.55|609.13||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the severe impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||609.13|326.55|
71857863|NCT04260464|143230275|OTHER||Test/Reference Ratio|144.63|||||TWO_SIDED|90.0|112.76|185.5||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the mild impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||185.50|112.76|
71906246|NCT00084929|143334993|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.813|0.9|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Specificity, for each radiologist, was calculated as the percentage of patients who did not have lesions larger than the prespecified threshold on colonoscopy as well as CT colonography The per-patient sensitivity, specificity, positive predictive value, and negative predictive value were first estimated for each radiologist, and then the average values among the radiologists were calculated.||0.9|0.813|
71906247|NCT00084929|143334993|OTHER||"P(D+|T+)"|0.23|||||TWO_SIDED|95.0|0.194|0.273|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Positive Predictive Value (PPV) the positive predictive value was calculated as the percentage of patients with CT colonographic findings that were also seen on colonoscopy||0.273|0.194|
71906248|NCT00084929|143334993|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998|||||Exact 95% confidence intervals were calculated for each radiologist, and large-sample 95% confidence intervals were calculated for overall estimates, with the use of standard errors that allowed for estimation of variation among radiologists.|Negative Predictive Value (NPV) the negative predictive value was calculated as the percentage of patients with no CT colonographic findings larger than the prespecified threshold that were not detected on colonoscopy.||0.998|0.990|
71906249|NCT00084929|143334994|OTHER||Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.853|0.93||||||"Accuracy: ROC analysis CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.93|0.853|
71906250|NCT00084929|143334994|OTHER||"Sensitivity: P(T+|D+)"|0.9|||||TWO_SIDED|95.0|0.832|0.96|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|"Sensitivity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.96|0.832|
71906251|NCT00084929|143334994|OTHER||"P(T-|D-)"|0.86|||||TWO_SIDED|95.0|0.817|0.902|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|"Specificity CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.902|0.817|
71906252|NCT00084929|143334994|OTHER||"P(D+|T+)"|0.25|||||TWO_SIDED|95.0|0.209|0.292||||||"Positive Predictive Value (PPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.292|0.209|
71906253|NCT00084929|143334994|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.99|0.998||||||"Negative Predictive Value (NPV) CTC lesions needed to be within 2 segments and 50% size of the lesions removed via colonoscopy to be considered detected"||0.998|0.990|
71906254|NCT00084929|143334995|OTHER||Area Under the Curve (AUC)|0.88|||||TWO_SIDED|95.0|0.842|0.913||||||Accuracy: ROC analysis||0.913|0.842|
71906255|NCT00084929|143334995|OTHER||"Sensitivity: P(T+|D+)"|0.87|||||TWO_SIDED|95.0|0.803|0.929|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.929|0.803|
71681218|NCT00772005|142881168|SUPERIORITY_OR_OTHER|||||||0.5674||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5674
71857864|NCT04260464|143230275|OTHER||Test/Reference Ratio|229.12|||||TWO_SIDED|90.0|189.97|276.35||||||ANOVA was used to compare the natural log transformed AUCinf for M1 between normal renal function group (Reference) and the moderate impaired renal function group (Test). Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model.||276.35|189.97|
71857865|NCT03469492|143230281|SUPERIORITY|||||||0.006|||||||Regression, Linear|||||||0.006
71857866|NCT03469492|143230285|SUPERIORITY|||||||0.266|||||||Mixed Models Analysis|||||||0.266
71857867|NCT03469492|143230288|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71857868|NCT03469492|143230289|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71857869|NCT01726049|143230291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|||||TWO_SIDED|95.0|-4.5|-0.3||||||||-0.3|-4.5|
71857870|NCT01726049|143230291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|||||TWO_SIDED|95.0|-7.1|-2.3||||||||-2.3|-7.1|
71857871|NCT01726049|143230292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.9|1.4||||||||1.4|-0.9|
71857872|NCT01726049|143230292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-0.3|1.6||||||||1.6|-0.3|
71857873|NCT01726049|143230293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.9|0.1||||||||0.1|-0.9|
71857874|NCT01726049|143230293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||||0.1|-0.5|
71857875|NCT01726049|143230294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-1.9|1.0||||||||1.0|-1.9|
71857876|NCT01726049|143230294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5|||||TWO_SIDED|95.0|-5.2|-1.8||||||||-1.8|-5.2|
71857877|NCT02806505|143230299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.6746|TWO_SIDED|95.0|0.49|3.06||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.06|0.49|0.6746
71857878|NCT02806505|143230300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3923|TWO_SIDED|95.0|0.6|3.76||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||3.76|0.60|0.3923
71857879|NCT02806505|143230301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8843|TWO_SIDED|95.0|0.43|2.68||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 12: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.68|0.43|0.8843
71857880|NCT02806505|143230301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5866|TWO_SIDED|95.0|0.28|2.04||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 24: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.||2.04|0.28|0.5866
71857881|NCT02416713|143230304|SUPERIORITY||relative change from baseline|0.66||||0.12|TWO_SIDED|95.0|-0.18|1.51|||Mixed Models Analysis|||||1.51|-0.18|0.12
71857882|NCT02416713|143230304|SUPERIORITY||relative change from baseline|-0.3||||0.49|TWO_SIDED|95.0|-1.17|0.57|||Mixed Models Analysis|||||0.57|-1.17|0.49
71857883|NCT02416713|143230304|SUPERIORITY||Slope|-0.16||||0.7|TWO_SIDED|95.0|-1.0|0.69|||Mixed Models Analysis|||||0.69|-1.00|0.70
71857884|NCT01343251|143230323|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED||||||Chi-squared|||||||0.48
71857885|NCT01343251|143230324|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||||||0.02
71857886|NCT01343251|143230325|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED|||||SF-36 Test 1 Total Score|t-test, 2 sided|||||||0.49
71857887|NCT01343251|143230325|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||SF-36 Test 2 Total Score|t-test, 2 sided|||||||0.91
71857888|NCT01343251|143230325|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||SF-36 Test 3 Total Score|t-test, 2 sided|||||||0.67
71857889|NCT01343251|143230325|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||SF-36 Test 4 Total Score|t-test, 2 sided|||||||<0.001
71857890|NCT01343251|143230326|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Chi-squared|||||||0.04
71857891|NCT01343251|143230327|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Chi-squared|||||||0.90
71857892|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-2.6||||0.887|TWO_SIDED|90.0|-6.2|1.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||1.0|-6.2|0.887
71857893|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.431|TWO_SIDED|90.0|-2.6|3.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 2||3.2|-2.6|0.431
71857894|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-1.0||||0.647|TWO_SIDED|90.0|-5.4|3.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||3.4|-5.4|0.647
71857895|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|2.4||||0.13|TWO_SIDED|90.0|-1.1|6.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||6.0|-1.1|0.130
71857896|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-2.5||||0.818|TWO_SIDED|90.0|-6.9|2.0|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||2.0|-6.9|0.818
71857897|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|0.3||||0.457|TWO_SIDED|90.0|-3.6|4.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||4.1|-3.6|0.457
71857898|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-3.1||||0.906|TWO_SIDED|90.0|-6.9|0.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||0.8|-6.9|0.906
71857899|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-0.4||||0.566|TWO_SIDED|90.0|-4.1|3.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||3.3|-4.1|0.566
71857900|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-1.3||||0.686|TWO_SIDED|90.0|-5.6|3.1|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||3.1|-5.6|0.686
71857901|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|1.4||||0.28|TWO_SIDED|90.0|-2.5|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||5.2|-2.5|0.280
71857902|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-2.4||||0.849|TWO_SIDED|90.0|-6.3|1.4|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.4|-6.3|0.849
71906256|NCT00084929|143334995|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.825|0.909|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.909|0.825|
71906257|NCT00084929|143334995|OTHER||"P(D+|T+)"|0.31|||||TWO_SIDED|95.0|0.256|0.355||||||Positive Predictive Value (PPV)||0.355|0.256|
71906258|NCT00084929|143334995|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.984|0.994||||||Negative Predictive Value (NPV)||0.994|0.984|
71906259|NCT00084929|143334996|OTHER||Area Under the Curve (AUC)|0.87|||||TWO_SIDED|95.0|0.833|0.902||||||Accuracy: ROC analysis||0.902|0.833|
71906260|NCT00084929|143334996|OTHER||"Sensitivity: P(T+|D+)"|0.84|||||TWO_SIDED|95.0|0.776|0.912|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.912|0.776|
71906261|NCT00084929|143334996|OTHER||"P(T-|D-)"|0.87|||||TWO_SIDED|95.0|0.831|0.914|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.914|0.831|
71906262|NCT00084929|143334996|OTHER||"P(D+|T+)"|0.35|||||TWO_SIDED|95.0|0.299|0.397||||||Positive Predictive Value (PPV)||0.397|0.299|
71681219|NCT00772005|142881169|SUPERIORITY_OR_OTHER|||||||0.3536||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3536
71906263|NCT00084929|143334996|OTHER||"P(D-|T-)"|0.99|||||TWO_SIDED|95.0|0.98|0.992||||||Negative Predictive Value (NPV)||0.992|0.980|
71906264|NCT00084929|143334997|OTHER||Area Under the Curve (AUC)|0.84|||||TWO_SIDED|95.0|0.81|0.878||||||Accuracy: ROC analysis||0.878|0.810|
71906265|NCT00084929|143334997|OTHER||"Sensitivity: P(T+|D+)"|0.78|||||TWO_SIDED|95.0|0.711|0.849|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.849|0.711|
71906266|NCT00084929|143334997|OTHER||"P(T-|D-)"|0.88|||||TWO_SIDED|95.0|0.84|0.92|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.92|0.840|
71906267|NCT00084929|143334997|OTHER||"P(D+|T+)"|0.4|||||TWO_SIDED|95.0|0.335|0.463||||||Positive Predictive Value (PPV)||0.463|0.335|
71906268|NCT00084929|143334997|OTHER||"P(D-|T-)"|0.98|||||TWO_SIDED|95.0|0.971|0.984||||||Negative Predictive Value (NPV)||0.984|0.971|
71906269|NCT00084929|143334998|OTHER||Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.763|0.828||||||Accuracy: ROC analysis||0.828|0.763|
71906270|NCT00084929|143334998|OTHER||"Sensitivity: P(T+|D+)"|0.65|||||TWO_SIDED|95.0|0.579|0.727|||||Sensitivity indicates the percent of patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity||0.727|0.579|
71681220|NCT00772005|142881169|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1940
71906271|NCT00084929|143334998|OTHER||"P(T-|D-)"|0.89|||||TWO_SIDED|95.0|0.851|0.923|||||Specificity indicates the percent of patients who had not lesions detected on optical colonoscopy, who had no lesions detected on CTC.|Specificity||0.923|0.851|
71906272|NCT00084929|143334998|OTHER||"P(D+|T+)"|0.45|||||TWO_SIDED|95.0|0.389|0.513||||||Positive Predictive Value (PPV)||0.513|0.389|
71906273|NCT00084929|143334998|OTHER||"P(D-|T-)"|0.95|||||TWO_SIDED|95.0|0.941|0.965||||||Negative Predictive Value (NPV)||0.965|0.941|
71857903|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|1.5||||0.254|TWO_SIDED|90.0|-2.2|5.2|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||5.2|-2.2|0.254
71857904|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|-2.7||||0.866|TWO_SIDED|90.0|-6.6|1.3|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.3|-6.6|0.866
71906274|NCT00084929|143334999|OTHER||"Sensitivity: P(T+|D+)"|0.84|STANDARD_ERROR_OF_MEAN|0.043|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=10mm))||||
71906275|NCT00084929|143335000|OTHER||"Sensitivity: P(T+|D+)"|0.82|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion (\>=9mm))||||
71906276|NCT00084929|143335001|OTHER||"Sensitivity: P(T+|D+)"|0.8|STANDARD_ERROR_OF_MEAN|0.041|||TWO_SIDED||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=8mm)||||
71906277|NCT00084929|143335002|OTHER||"Sensitivity: P(T+|D+)"|0.75|STANDARD_ERROR_OF_MEAN|0.042|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=7mm)||||
71857905|NCT03927690|143230368|SUPERIORITY||Difference (Test vs Reference)|2.0||||0.198|TWO_SIDED|90.0|-1.9|5.8|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||5.8|-1.9|0.198
71857906|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.2||||0.998|TWO_SIDED|90.0|1.08|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.33|1.08|0.998
71857907|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.0||||0.527|TWO_SIDED|90.0|0.92|1.09|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 8||1.09|0.92|0.527
71857908|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.21||||0.999|TWO_SIDED|90.0|1.1|1.33|||Mixed model repeated measures analysis||Comparison of model-based mean estimates|Day 15||1.33|1.10|0.999
71857909|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.03||||0.716|TWO_SIDED|90.0|0.95|1.12|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 15||1.12|0.95|0.716
71857910|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.21||||1|TWO_SIDED|90.0|1.13|1.31|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.31|1.13|1.000
71906278|NCT00084929|143335003|OTHER||"Sensitivity: P(T+|D+)"|0.7|STANDARD_ERROR_OF_MEAN|0.046|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=6mm)||||
71906279|NCT00084929|143335004|OTHER||"Sensitivity: P(T+|D+)"|0.59|STANDARD_ERROR_OF_MEAN|0.045|||||||||||Sensitivity indicates the percent of lesions in patients who had a lesions (of the specified size) detected by optical colonoscopy, which were detected by CTC|Sensitivity (per lesion \>=5mm)||||
71681221|NCT00772005|142881169|SUPERIORITY_OR_OTHER|||||||0.2129||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2129
71681222|NCT00772005|142881170|SUPERIORITY_OR_OTHER|||||||0.584||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5840
71857911|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|0.98||||0.281|TWO_SIDED|90.0|0.91|1.05|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 29||1.05|0.91|0.281
71857912|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.32||||1|TWO_SIDED|90.0|1.2|1.46|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.46|1.20|1.000
71857913|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|0.96||||0.2|TWO_SIDED|90.0|0.88|1.04|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 43||1.04|0.88|0.200
71857914|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|1.18||||1|TWO_SIDED|90.0|1.09|1.28|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.28|1.09|1.000
71857915|NCT03927690|143230374|SUPERIORITY||Ratio (Test vs Reference)|0.94||||0.083|TWO_SIDED|90.0|0.87|1.01|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 57||1.01|0.87|0.083
71681223|NCT00772005|142881170|SUPERIORITY_OR_OTHER|||||||0.6028||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6028
71857916|NCT03927690|143230374|SUPERIORITY||Ratio(Test vs Reference)|1.26||||1|TWO_SIDED|90.0|1.14|1.38|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.38|1.14|1.000
71857917|NCT03927690|143230374|SUPERIORITY||Ratio(Test vs Reference)|0.96||||0.254|TWO_SIDED|90.0|0.88|1.06|||Mixed model repeated measures analysis||Comparison of model-based mean estimates.|Day 85||1.06|0.88|0.254
71857918|NCT01376050|143230401|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71857919|NCT01376050|143230402|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>0.05
71857920|NCT03463577|143230403|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.38|||||TWO_SIDED|98.75|1.21|1.58|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted relative risk (RR) for pre-eclampsia and eclampsia in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.58|1.21|
71906280|NCT00424294|143335007|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Chi-squared|||||||0.733
71906281|NCT00424294|143335008|SUPERIORITY_OR_OTHER|||||||0.463|TWO_SIDED||||||Chi-squared|||Week 1: p-value was calculated by Chi-square test.||||0.463
71906282|NCT00424294|143335008|SUPERIORITY_OR_OTHER|||||||0.549|TWO_SIDED||||||Chi-squared|||Week 2: p-value was calculated by Chi-square test.||||0.549
71906283|NCT00424294|143335008|SUPERIORITY_OR_OTHER|||||||0.272|TWO_SIDED||||||Chi-squared|||Week 4: p-value was calculated by Chi-square test.||||0.272
71906284|NCT00424294|143335008|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Chi-squared|||Week 8: p-value was calculated by Chi-square test.||||0.265
71857921|NCT03463577|143230403|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.28|||||TWO_SIDED|98.75|1.12|1.47|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for intra-uterine infections (chorioamnionitis and endometritis) in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||1.47|1.12|
71906285|NCT00424294|143335009|SUPERIORITY_OR_OTHER|||||||0.939|TWO_SIDED||||||Fisher Exact|||Week 4: p-value was calculated by Fisher exact test.||||0.939
71906286|NCT00424294|143335009|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||Fisher Exact|||Week 8: p-value was calculated by Fisher exact test.||||0.323
71906287|NCT00424294|143335009|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.338
71906288|NCT00424294|143335010|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.||||0.746
71857922|NCT03463577|143230404|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|0.71|||||TWO_SIDED|98.75|0.64|0.78|||||Adjusted relative risk with 98.75% CI was estimated by Poisson regression model|Demonstration of adjusted RR for preterm delivery in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was less than 2 (non-inferiority testing).||0.78|0.64|
71857923|NCT03463577|143230405|NON_INFERIORITY|The objective was to rule out a two-fold increase (non-inferiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis Ho: RR ≥ 2 was rejected if upper limit of the 98.75% CI for the adjusted RR was below 2.|Risk Ratio (RR)|1.04|||||TWO_SIDED|98.75|0.94|1.16|||||Adjusted RR with 98.75% CI-Poisson regression model|Demonstration of adjusted RR for small for gestational age in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was less than 2 (non-inferiority testing).||1.16|0.94|
71857924|NCT03463577|143230406|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.7|0.98|||||Adjusted RR with 95% CI -Poisson regression model|Assessment of adjusted RR for poor fetal growth in the Exposed pregnant women cohort (on or after 1st day of 27th week of pregnancy) compared to the Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.98|0.70|
71857925|NCT03463577|143230406|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.99|1.72|||||Adjusted RR with 95% CI - Poisson regression model|Assessment of adjusted RR for placental abortion in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.72|0.99|
71857926|NCT03463577|143230406|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. Superiority to be concluded if lower limit of the 95% CI for the adjusted RR is above 1.|Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.64|0.91|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for preterm pre-labor rupture of membranes in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.91|0.64|
71857927|NCT03463577|143230407|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR =1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.38|||||TWO_SIDED|95.0|0.22|0.67|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for stillbirth/fetal death in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||0.67|0.22|
71906289|NCT00424294|143335011|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||ANCOVA|||Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.635
71906290|NCT00424294|143335011|SUPERIORITY_OR_OTHER|||||||0.044|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.044
71906291|NCT00424294|143335011|SUPERIORITY_OR_OTHER|||||||0.957|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.957
71906292|NCT00424294|143335011|SUPERIORITY_OR_OTHER|||||||0.597|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.597
71906293|NCT00424294|143335011|SUPERIORITY_OR_OTHER|||||||0.96|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.960
71906294|NCT00424294|143335012|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.252
71906295|NCT00424294|143335012|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.032
71906296|NCT00424294|143335012|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.031
71906297|NCT00424294|143335012|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.018
71906298|NCT00424294|143335012|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.170
71906299|NCT00424294|143335013|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.507
71906300|NCT00424294|143335013|SUPERIORITY_OR_OTHER|||||||0.743|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.743
71906301|NCT00424294|143335013|SUPERIORITY_OR_OTHER|||||||0.914|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.914
71906302|NCT00424294|143335013|SUPERIORITY_OR_OTHER|||||||0.715|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.715
71681224|NCT00772005|142881170|SUPERIORITY_OR_OTHER|||||||0.1426||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1426
71857928|NCT03463577|143230407|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.86|1.33|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for transfusion during delivery hospitalization in Exposed women cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical women cohort was 1 or differed from 1 (superiority testing).||1.33|0.86|
71857929|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.38|1.73|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for neonatal death in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.73|0.38|
71857930|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.35|||||TWO_SIDED|95.0|0.81|2.24|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of nervous system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.24|0.81|
71857931|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.06|1.29|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of eye in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.29|1.06|
71857932|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|2.02|||||TWO_SIDED|95.0|1.59|2.55|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of ear, face or neck in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||2.55|1.59|
71857933|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.96|1.31|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of cardiovascular system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infant cohort was 1 or differed from 1 (superiority testing).||1.31|0.96|
71857934|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.34|||||TWO_SIDED|95.0|1.07|1.68|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of respiratory system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was1 or differed from 1 (superiority testing).||1.68|1.07|
71906303|NCT00424294|143335013|SUPERIORITY_OR_OTHER|||||||0.558|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.558
71906304|NCT00424294|143335014|SUPERIORITY_OR_OTHER|||||||0.172|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.172
71906305|NCT00424294|143335014|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.738
71906306|NCT00424294|143335014|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
71681225|NCT00772005|142881171|SUPERIORITY_OR_OTHER|||||||0.5989||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5989
71857935|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.41||||||95.0|0.78|2.57|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for clefts in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.57|0.78|
71857936|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.75|||||TWO_SIDED|95.0|1.57|1.95|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of upper gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.95|1.57|
71857937|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.36|1.12|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of lower gastrointestinal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.12|0.36|
71857938|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|1.01|1.42|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of genital organs in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.42|1.01|
71857939|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.4|||||TWO_SIDED|95.0|1.04|1.88|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of renal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing.||1.88|1.04|
71857940|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.5||||||95.0|1.21|1.86|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of musculoskeletal system in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.86|1.21|
71857941|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.13|||||TWO_SIDED|95.0|0.85|1.52|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of limb in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.52|0.85|
71857942|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.98|||||TWO_SIDED|95.0|1.76|2.23|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for congenital anomalies of integument in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||2.23|1.76|
71857943|NCT03463577|143230408|SUPERIORITY|The objective was to explore differences (superiority testing) in the incidence rate of each of the maternal and infant adverse events, among vaccinated women with Boostrix and their infants as compared to the incidence in a matched cohort of unvaccinated women and their infants. The null hypothesis H0 RR=1 was rejected if lower limit of 95% CI for adjusted RR was above 1.|Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.64|1.85|||||Adjusted RR with 95% CI-Poisson regression model|Assessment of adjusted RR for other and unspecified congenital anomalies in Exposed infants cohort (on or after 1st day of 27th week of pregnancy) compared to Unexposed historical infants cohort was 1 or differed from 1 (superiority testing).||1.85|0.64|
71857944|NCT05694533|143230412|OTHER|Descriptive only.|Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.76|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.76|
71857945|NCT05694533|143230412|OTHER|Descriptive only.|Geometric Mean Ratio|0.8|||||TWO_SIDED|90.0|0.69|0.93||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.93|0.69|
71857946|NCT05694533|143230413|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.92||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.92|0.78|
71906307|NCT00424294|143335014|SUPERIORITY_OR_OTHER|||||||0.428|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.428
71906308|NCT00424294|143335014|SUPERIORITY_OR_OTHER|||||||0.861|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.861
71906309|NCT00424294|143335015|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.325
71906310|NCT00424294|143335015|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.386
71906311|NCT00424294|143335015|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.532
71906312|NCT00424294|143335015|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.909
71906313|NCT00424294|143335015|SUPERIORITY_OR_OTHER|||||||0.994|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.994
71906314|NCT00424294|143335016|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.369
71906315|NCT00424294|143335016|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.666
71906316|NCT00424294|143335016|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.530
71906317|NCT00424294|143335016|SUPERIORITY_OR_OTHER|||||||0.632|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.632
71906318|NCT00424294|143335016|SUPERIORITY_OR_OTHER|||||||0.801|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.801
71906319|NCT00424294|143335017|SUPERIORITY_OR_OTHER|||||||0.052|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.052
71906320|NCT00424294|143335017|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.108
71906321|NCT00424294|143335017|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.573
71906322|NCT00424294|143335017|SUPERIORITY_OR_OTHER|||||||0.342|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.342
71906323|NCT00424294|143335017|SUPERIORITY_OR_OTHER|||||||0.501|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.501
71906324|NCT00424294|143335018|SUPERIORITY_OR_OTHER|||||||0.701|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.701
71906325|NCT00424294|143335018|SUPERIORITY_OR_OTHER|||||||0.167|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.167
71906326|NCT00424294|143335018|SUPERIORITY_OR_OTHER|||||||0.948|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.948
71906327|NCT00424294|143335018|SUPERIORITY_OR_OTHER|||||||0.834|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.834
71906328|NCT00424294|143335018|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.977
71906329|NCT00424294|143335019|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.291
71906330|NCT00424294|143335019|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.080
71906331|NCT00424294|143335019|SUPERIORITY_OR_OTHER|||||||0.466|TWO_SIDED||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.466
71906332|NCT00424294|143335019|SUPERIORITY_OR_OTHER|||||||0.267|TWO_SIDED||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.267
71906333|NCT00424294|143335019|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.||||0.100
71906334|NCT04397718|143335029|SUPERIORITY||Odds Ratio (OR)|1.19||||0.667|TWO_SIDED|95.0|0.46|3.06|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD|||3.06|0.46|0.667
71906335|NCT04397718|143335030|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.876|TWO_SIDED|95.0|0.58|1.49|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD.|||1.49|0.58|0.876
71906336|NCT04397718|143335031|SUPERIORITY||Odds Ratio (OR)|0.95||||0.991|TWO_SIDED|95.0|0.31|2.92|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||2.92|0.31|0.991
71906337|NCT04397718|143335032|SUPERIORITY||Quantile Regression|0.0||||0.841|TWO_SIDED|95.0|-2.03|4.11|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||4.11|-2.03|0.841
71906338|NCT04397718|143335033|SUPERIORITY||Quantile Regression|0.0||||0.746|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||Adjusted for age, hypertension, and COPD|||0|0|0.746
71906339|NCT04397718|143335034|SUPERIORITY||Hazard Ratio (HR)|2.3||||0.1|TWO_SIDED|95.0|0.72|7.39|||Log Rank||Cox regression model adjusted for age, hypertension, and COPD|||7.39|0.72|0.1
71906340|NCT04397718|143335035|SUPERIORITY||Odds Ratio (OR)|0.82||||0.425|TWO_SIDED|95.0|0.33|2.0|||Fisher Exact||||Logistical regression adjusted for age, hypertension, COPD, and baseline severity score.|2|0.33|0.425
71906341|NCT04397718|143335036|SUPERIORITY||Odds Ratio (OR)|1.22||||0.688|TWO_SIDED|95.0|0.44|3.42|||Chi-squared||Logistic regression adjusted for age, hypertension, and COPD.|||3.42|0.44|0.688
71906342|NCT01797965|143335053|SUPERIORITY|||||||0.5937|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.5937
71906343|NCT01797965|143335053|SUPERIORITY|||||||0.6233|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.6233
71906344|NCT01797965|143335053|SUPERIORITY|||||||0.1884|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.1884
71906345|NCT01797965|143335054|SUPERIORITY|||||||0.0204|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.0204
71906346|NCT01797965|143335054|SUPERIORITY|||||||0.0805|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.0805
71681226|NCT00772005|142881171|SUPERIORITY_OR_OTHER|||||||0.7411||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7411
71681227|NCT00772005|142881171|SUPERIORITY_OR_OTHER|||||||0.1566||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1566
71906347|NCT01797965|143335054|SUPERIORITY|||||||0.2535|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2535
71906348|NCT01797965|143335054|SUPERIORITY|||||||0.4738|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.4738
71906349|NCT01797965|143335054|SUPERIORITY|||||||0.2302|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.2302
71906350|NCT01797965|143335054|SUPERIORITY|||||||0.8522|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8522
71906351|NCT01797965|143335054|SUPERIORITY|||||||0.0431|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.0431
71906352|NCT01797965|143335054|SUPERIORITY|||||||0.0339|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.0339
71906353|NCT01797965|143335054|SUPERIORITY|||||||0.3195|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.3195
71906354|NCT01797965|143335054|SUPERIORITY|||||||0.2119|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.2119
71906355|NCT01797965|143335054|SUPERIORITY|||||||0.3619|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.3619
71906356|NCT01797965|143335054|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.0170
71906357|NCT01797965|143335054|SUPERIORITY|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.0170
71906358|NCT01797965|143335054|SUPERIORITY|||||||0.0849|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.0849
71906359|NCT01797965|143335054|SUPERIORITY|||||||0.0057|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.0057
71906360|NCT01797965|143335054|SUPERIORITY|||||||0.396|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.3960
71906361|NCT01797965|143335056|SUPERIORITY||Odds Ratio (OR)|0.902||||0.8417|TWO_SIDED|95.0|0.329|2.473|||Regression, Logistic|Adjusted for the baseline relapse rate, history of prior IFN beta use (yes/no), baseline EDSS (\<=2.5 vs \>2.5) and baseline age (\<=35 vs \>35).||||2.473|0.329|0.8417
71906362|NCT01797965|143335078|SUPERIORITY|||||||0.3813|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 12||||0.3813
71906363|NCT01797965|143335078|SUPERIORITY|||||||0.1679|||||||ANOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 24||||0.1679
71681228|NCT00772005|142881172|SUPERIORITY_OR_OTHER|||||||0.261||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2610
71906364|NCT01797965|143335078|SUPERIORITY|||||||0.5634|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 48||||0.5634
71906365|NCT01797965|143335078|SUPERIORITY|||||||0.7003|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 144||||0.7003
71857947|NCT05694533|143230413|OTHER|Descriptive only.|Geometric Mean Ratio|0.81|||||TWO_SIDED|90.0|0.74|0.89||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.89|0.74|
71857948|NCT05694533|143230414|OTHER|Descriptive only.|Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.78|0.91||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between Midazolam on Day 15 and Midazolam on Day 1.||0.91|0.78|
71857949|NCT05694533|143230414|OTHER|Descriptive only.|Geometric Mean Ratio|0.87|||||TWO_SIDED|90.0|0.78|0.97||||A random effects model was used to calculate the confidence interval.|Day 15/Day 1|The comparison is between 1-hydroxymidazolam on Day 15 and 1-hydroxymidazolam on Day 1.||0.97|0.78|
71857950|NCT00107978|143230442|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|2.5||||||95.0|-2.9|7.9||p-values were not calculated in deference to confidence intervals.|2-sided 95% confidence interval|2-sided 95% confidence interval calculated on the difference in cure rates between treatment groups.||||7.9|-2.9|
71857951|NCT00704171|143230443|SUPERIORITY_OR_OTHER|||||||0.257|||||||Fisher Exact|||Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).||||0.257
71857952|NCT00704171|143230444|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|two-sided||||||<0.001
71857953|NCT00704171|143230445|SUPERIORITY_OR_OTHER|||||||0.79|||||||Kaplan-Meier|Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.||||||0.790
71857954|NCT00704171|143230446|SUPERIORITY_OR_OTHER|||||||0.559|||||||2-sample t-test|||||||0.559
71681229|NCT00772005|142881172|SUPERIORITY_OR_OTHER|||||||0.4457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4457
71857955|NCT00704171|143230447|SUPERIORITY_OR_OTHER|||||||0.292|||||||2-sample t-test|||||||0.292
71857956|NCT00704171|143230448|SUPERIORITY_OR_OTHER|||||||0.53||||||For subgroup with pre-randomization air leak grade of 1|Fisher Exact|||||||0.53
71857957|NCT00704171|143230448|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||For subgroup with pre-randomization air leak grade of 2 or 3|Fisher Exact|||||||.013
71857958|NCT04269434|143230463|NON_INFERIORITY|"The No Screening Arm is considered non-inferior if the upper limit of the 95% Confidence Interval is less than 1.25"|Incidence rate ratio|1.318|||||TWO_SIDED|95.0|1.068|1.627||||||Compared to screening group||1.627|1.068|
71857959|NCT04269434|143230464|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.788|||||TWO_SIDED|95.0|0.719|0.863||||||For Azithromycin. Compared to screening group||0.863|0.719|
71857960|NCT04269434|143230464|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.561|||||TWO_SIDED|95.0|0.426|0.739||||||For Ceftriaxone. Compared to screening group||0.739|0.426|
71857961|NCT04269434|143230464|NON_INFERIORITY|No prespecified margin|Incidence rate ratio|0.55|||||TWO_SIDED|95.0|0.515|0.588||||||For Doxycycline. Compared to screening group||0.588|0.515|
71857962|NCT04269434|143230465|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.373|||||TWO_SIDED|95.0|0.963|1.956||||||Compared to screening group||1.956|0.963|
71857963|NCT04269434|143230466|NON_INFERIORITY|No prespecified margin.|Incidence rate ratio|1.471|||||TWO_SIDED|95.0|0.943|2.299||||||Compared to screening group||2.299|0.943|
71857964|NCT04962698|143230467|SUPERIORITY||||||>|0.00238||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||>0.00238
71857965|NCT04962698|143230468|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was 0.05.|ANOVA|||||||<0.001
71857966|NCT04962698|143230469|SUPERIORITY|||||||0.028||||||The threshold for statistical significance was 0.05.|ANOVA|||||||0.028
71906366|NCT01797965|143335078|SUPERIORITY|||||||0.7812|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 168||||0.7812
71906367|NCT01797965|143335078|SUPERIORITY|||||||0.3246|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 192||||0.3246
71906368|NCT01797965|143335078|SUPERIORITY|||||||0.6423|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 216||||0.6423
71906369|NCT01797965|143335078|SUPERIORITY|||||||0.0288|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change to Week 240||||0.0288
71906370|NCT01797965|143335079|SUPERIORITY|||||||0.2567|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301||||0.2567
71906371|NCT01797965|143335079|SUPERIORITY|||||||0.6152|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301||||0.6152
71906372|NCT01797965|143335079|SUPERIORITY|||||||0.2024|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301||||0.2024
71906373|NCT01797965|143335079|SUPERIORITY|||||||0.9988|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301||||0.9988
71906374|NCT01797965|143335079|SUPERIORITY|||||||0.7962|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301||||0.7962
71906375|NCT01797965|143335079|SUPERIORITY|||||||0.8486|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301||||0.8486
71906376|NCT01797965|143335079|SUPERIORITY|||||||0.4478|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301||||0.4478
71906377|NCT01797965|143335079|SUPERIORITY|||||||0.325|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301||||0.3250
71906378|NCT01797965|143335079|SUPERIORITY|||||||0.129|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301||||0.1290
71857967|NCT04962698|143230470|SUPERIORITY||||||<|0.00231||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.00231
71857968|NCT04962698|143230471|SUPERIORITY||||||<|0.002||||||The threshold for statistical significance was 0.00238, which was adjusted from the original 0.05 as described below.|Wilcoxon (Mann-Whitney)|The alpha value for p-value comparison was adjusted for 21 pair-wise comparisons (0.05/21 = 0.00238) across seven tasks.||||||<0.0020
71857969|NCT01664923|143230535|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.181|0.32||P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.320|0.181|<0.0001
71857970|NCT01664923|143230536|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.19|||<|0.0001|TWO_SIDED|95.0|0.137|0.264||P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.264|0.137|<0.0001
71857971|NCT01664923|143230537|SUPERIORITY_OR_OTHER||Difference in rates|50.0|||<|0.0001|TWO_SIDED|95.0|41.4|58.5|||Cochran-Mantel-Haenszel|Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.|Enzalutamide response rate minus bicalutamide response rate.|||58.5|41.4|<0.0001
71857972|NCT01664923|143230538|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.324|||<|0.0001|TWO_SIDED|95.0|0.211|0.497|||Log Rank|P-value is based on an unstratified log-rank test.|Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with \< 1 favoring enzalutamide.|||0.497|0.211|<0.0001
71857973|NCT01664923|143230539|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.4945|TWO_SIDED|95.0|0.695|1.192||This secondary endpoint was not adjusted for multiple comparisons.|Log Rank|P-value is based on a log-rank test stratified by disease stage at study entry.|Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.|||1.192|0.695|0.4945
71857974|NCT01664923|143230540|SUPERIORITY_OR_OTHER||Difference in objective response rate|46.05|||<|0.0001|TWO_SIDED|95.0|26.79|65.3||This secondary endpoint was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Based on unstratified Cochran-Mantel-Haenszel mean score test.||||65.30|26.79|<0.0001
71857975|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-0.791||||0.0002|TWO_SIDED|95.0|-1.203|-0.378|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.378|-1.203|0.0002
71857976|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-0.851|||<|0.0001|TWO_SIDED|95.0|-1.263|-0.439|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-0.439|-1.263|<.0001
71857977|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-1.545|||<|0.0001|TWO_SIDED|95.0|-1.954|-1.135|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 4b (including all time points).||-1.135|-1.954|<.0001
71857978|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-1.208|||<|0.0001|TWO_SIDED|95.0|-1.639|-0.778|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.778|-1.639|<.0001
71857979|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-1.245|||<|0.0001|TWO_SIDED|95.0|-1.679|-0.811|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-0.811|-1.679|<.0001
71857980|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-1.846|||<|0.0001|TWO_SIDED|95.0|-2.273|-1.418|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 5b (including all time points).||-1.418|-2.273|<.0001
71857981|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-1.696|||<|0.0001|TWO_SIDED|95.0|-2.08|-1.312|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.2% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.312|-2.080|<.0001
71857982|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-1.617|||<|0.0001|TWO_SIDED|95.0|-2.001|-1.232|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.4% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.232|-2.001|<.0001
71857983|NCT03231969|143230543|SUPERIORITY||Mean Difference (Final Values)|-2.009|||<|0.0001|TWO_SIDED|95.0|-2.387|-1.63|||ANCOVA|||Treatment difference (95%CI): Bilastine 0.6% arm minus Bilastine 0% (Vehicle) arm at Visit 6 (including all time points).||-1.630|-2.387|<.0001
71906379|NCT01797965|143335079|SUPERIORITY|||||||0.7295|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301||||0.7295
71906380|NCT01797965|143335079|SUPERIORITY|||||||0.8647|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301||||0.8647
71906381|NCT01797965|143335079|SUPERIORITY|||||||0.2183|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301||||0.2183
71906382|NCT01797965|143335079|SUPERIORITY|||||||0.3945|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303||||0.3945
71906383|NCT01797965|143335079|SUPERIORITY|||||||0.5068|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303||||0.5068
71906384|NCT01797965|143335079|SUPERIORITY|||||||0.1669|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303||||0.1669
71857984|NCT03247738|143230544|SUPERIORITY|The primary end point of our study was the comparison of platelet reactivity measured by VerifyNow PRU between cangrelor and placebo at 30 minutes after drugs were administered at the start of PCI. Assuming a common standard deviation of 70 PRU, a sample size of 20 patients per group would allow detection of a 70 PRU difference between groups with 85% power and a two-sided α = 0.05. Considering the 2 arms and a possible 25% rate of invalid PD results we planned to randomize up to 50 patients.|Mean Difference (Net)|152.0|||<|0.001|TWO_SIDED|95.0|108.0|195.0|||ANCOVA|the baseline value of platelet reactivity used as a covariate||||195|108|<0.001
71857985|NCT00129649|143230546|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71857986|NCT02561806|143230570|NON_INFERIORITY|Non-inferiority margin was -12.6% for 97.5% confidence interval|Risk Difference (RD)|0.321|||<|0.001|TWO_SIDED|97.5|0.198|0.445|||Regression, Logistic|||||0.445|0.198|<0.001
71857987|NCT02561806|143230571|SUPERIORITY||Risk Ratio (RR)|1.285|||<|0.001|TWO_SIDED|95.0|1.13|1.439|||Regression, Logistic|||||1.439|1.130|<0.001
71857988|NCT02561806|143230572|SUPERIORITY||Risk Ratio (RR)|2.699||||0.009|TWO_SIDED|95.0|1.423|3.975|||Regression, Logistic|||||3.975|1.423|0.009
71857989|NCT02561806|143230573|SUPERIORITY||Risk Ratio (RR)|1.469|||<|0.001|TWO_SIDED|95.0|1.244|1.695|||Regression, Logistic|||||1.695|1.244|<0.001
71857990|NCT02561806|143230574|SUPERIORITY||Risk Ratio (RR)|3.421||||0.021|TWO_SIDED|95.0|1.353|5.488|||Regression, Logistic|||||5.488|1.353|0.021
71857991|NCT02561806|143230581|SUPERIORITY||Risk Ratio (RR)|1.391||||0.012|TWO_SIDED|95.0|1.085|1.698|||Regression, Logistic|||||1.698|1.085|0.012
71857992|NCT02547441|143230594|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
71857993|NCT02547441|143230595|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.019
71857994|NCT01322009|143230604|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|Analysis run over study period but data entered only for the 6 h time point||||||>0.05
71857995|NCT00511797|143230626|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|-1.49|-0.34||Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.|t-test, 1 sided|||Three null hypotheses were sequentially tested. H01: DRSP 3 mg \>= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg \< Placebo (Active is greater in decrease of score), H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo, H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.34|-1.49|<0.001
71857996|NCT00511797|143230626|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.277|<|0.001||95.0|-1.64|-0.55|||t-test, 1 sided|||Second null hypothesis was tested. H02: DRSP 2 mg \>= Placebo vs H12: DRSP 2 mg \< Placebo.||-0.55|-1.64|<0.001
71857997|NCT00511797|143230626|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.28|<|0.001||95.0|-2.0|-0.89|||t-test, 1 sided|||Third null hypotheses was tested. H03: DRSP 1 mg \>= Placebo vs H13: DRSP 1 mg \< Placebo.||-0.89|-2.00|<0.001
71857998|NCT00511797|143230627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-1.74|-0.46|||t-test, 1 sided|||Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.||-0.46|-1.74|<0.001
71857999|NCT00511797|143230627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.306|<|0.001||95.0|-1.95|-0.73|||t-test, 1 sided|||||-0.73|-1.95|<0.001
71858000|NCT00511797|143230627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53|STANDARD_ERROR_OF_MEAN|0.317|<|0.001||95.0|-2.16|-0.9|||t-test, 1 sided|||||-0.90|-2.16|<0.001
71858001|NCT03974100|143230650|EQUIVALENCE|Equivalence criteria (analysis set PPS): 95% CI for difference in means contained in \[-1.45%, 1.45%\]|Mean Difference (Final Values)|-0.145|STANDARD_ERROR_OF_MEAN|0.3325|||TWO_SIDED|95.0|-0.798|0.509|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.509|-0.798|
71858002|NCT03974100|143230651|EQUIVALENCE|Equivalence criteria (analysis set TP1 FAS): 95% CI for difference in means contained in \[-1.45%, 1.45%\] (criteria 1) or in \[-2.00%, 2.00%\] (criteria 2)|Mean Difference (Final Values)|-0.177|STANDARD_ERROR_OF_MEAN|0.3321|||TWO_SIDED|95.0|-0.83|0.475|||Mixed-model repeated measures (MMRM)|MMRM included treatment, prior bisphosphonate use, DXA machine type, visit, visit-treatment interaction, and baseline LS-BMD as a continuous covariate|Difference GP2411 (Test) - EU-Prolia (Reference)|||0.475|-0.830|
71858003|NCT03974100|143230652|EQUIVALENCE|Equivalence criteria (analysis set PDS): 95% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
71858004|NCT03974100|143230652|EQUIVALENCE|Equivalence criteria (analysis set PDS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.98|1.01|||ANCOVA|ANCOVA was performed on log-transformed AUEC including treatment and log baseline CTX value as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.01|0.98|
71858005|NCT03974100|143230653|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.92|1.03|||ANCOVA|ANCOVA was performed on log-transformed Cmax including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.03|0.92|
71858006|NCT03974100|143230654|EQUIVALENCE|Equivalence criteria (analysis set PKS): 90% CI for ratio of geometric means contained in \[0.80, 1.25%\]|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05|||ANCOVA|ANCOVA was performed on log-transformed AUCinf including treatment and weight as a continuous covariate|Geometric mean ratio of GP2411 (Test) to EU-Prolia (Reference)|||1.05|0.93|
71858007|NCT03269695|143230702|SUPERIORITY||Treatment difference|1.8||||1|TWO_SIDED|95.0|-41.0|47.2|||Chan and Zhang (1999)|||||47.2|-41.0|1.0000
71858008|NCT03269695|143230703|SUPERIORITY||Treatment difference|0.0||||1|TWO_SIDED|95.0|-37.0|37.0|||Chan and Zhang (1999)|||||37.0|-37.0|1.0000
71858009|NCT03269695|143230704|SUPERIORITY||Treatment difference|14.3||||0.47|TWO_SIDED|95.0|-23.8|57.9|||Chan and Zhang (1999)|||||57.9|-23.8|0.4700
71906385|NCT01797965|143335079|SUPERIORITY|||||||0.5038|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303||||0.5038
71681230|NCT00772005|142881172|SUPERIORITY_OR_OTHER|||||||0.1342||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1342
71858010|NCT03269695|143230705|SUPERIORITY||Treatment difference|10.0||||0.5221|TWO_SIDED|95.0|-20.7|45.6|||Chan and Zhang (1999)|||||45.6|-20.7|0.5221
71858011|NCT03269695|143230706|SUPERIORITY||Treatment difference|32.1||||0.3166|TWO_SIDED|95.0|-23.7|74.1|||Chan and Zhang (1999)|||||74.1|-23.7|0.3166
71858012|NCT03269695|143230707|SUPERIORITY||Treatment difference|20.0||||0.5234|TWO_SIDED|95.0|-22.9|58.5|||Chan and Zhang (1999)|||||58.5|-22.9|0.5234
71858013|NCT03269695|143230708|SUPERIORITY||Treatment difference|-25.0||||0.7393|TWO_SIDED|95.0|-69.6|29.1|||Chan and Zhang (1999)|||||29.1|-69.6|0.7393
71858014|NCT03269695|143230709|SUPERIORITY||Least squares mean difference|5.8||||0.2705|TWO_SIDED|95.0|-5.08|16.67|||ANCOVA|||||16.67|-5.08|0.2705
71858015|NCT03269695|143230710|SUPERIORITY||Treatment difference|48.2||||0.0732|TWO_SIDED|95.0|-4.4|84.7|||Chan and Zhang (1999)|||||84.7|-4.4|0.0732
71858016|NCT03269695|143230711|SUPERIORITY||Treatment difference|30.0||||0.2633|TWO_SIDED|95.0|-18.4|69.2|||Chan and Zhang (1999)|||||69.2|-18.4|0.2633
71858017|NCT03269695|143230712|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.15|6.54|||Generalized Linear Mixed Model|||At Week 2||6.54|0.15|1.0000
71858018|NCT03269695|143230712|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6691|TWO_SIDED|95.0|0.23|10.0|||Generalized Linear Mixed Model|||At Week 4||10.00|0.23|0.6691
71906386|NCT01797965|143335079|SUPERIORITY|||||||0.6001|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 303||||0.6001
71906387|NCT01797965|143335079|SUPERIORITY|||||||0.8617|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 168 for 303||||0.8617
71906388|NCT01797965|143335079|SUPERIORITY|||||||0.259|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 192 for 303||||0.2590
71906389|NCT01797965|143335079|SUPERIORITY|||||||0.5159|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 216 for 303||||0.5159
71906390|NCT01797965|143335079|SUPERIORITY|||||||0.6123|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (\<=35 vs \>35) and history of prior IFN beta.||Change from Baseline 301 to Week 240 for 303||||0.6123
71858019|NCT03269695|143230712|SUPERIORITY||Odds Ratio (OR)|0.62||||0.6248|TWO_SIDED|95.0|0.09|4.4|||Generalized Linear Mixed Model|||At Week 8||4.40|0.09|0.6248
71858020|NCT03269695|143230712|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9965|TWO_SIDED|95.0|0.12|8.3|||Generalized Linear Mixed Model|||At Week 12||8.30|0.12|0.9965
71858021|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.13||0.23|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.23
71858022|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.07
71858023|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.99|TWO_SIDED||||||Regression, Linear|||Orienting. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.99
71858024|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.16||0.005|TWO_SIDED||||||Regression, Linear|||Fidget. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and BeSAFE).||||.005
71858025|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.11||0.01|TWO_SIDED||||||Regression, Linear|||Overall Behavior. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.01
71858026|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.04|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.04
71906391|NCT00441103|143335107|SUPERIORITY_OR_OTHER||||||<|0.001||||||Non-parametric analysis of variance (ANOVA) with effects for treatment and the absence/presence of Gd-enhancing lesions at baseline as factors|ANOVA|||||||<0.001
71906392|NCT00441103|143335108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.67|STANDARD_DEVIATION|2.33|<|0.001|||||||Wilcoxon signed-rank test|||Mean difference was calculated by subtracting 'Day 1 up to Week 16' from 'Week 17 up to Week 40' and analyzed using Wilcoxon signed-rank test.||||<0.001
71906393|NCT00239837|143335120|SUPERIORITY_OR_OTHER_LEGACY||Wald χ2|7.14||||0.008|TWO_SIDED||||||Regression, Logistic|Data analyzed using repeated logistic regression model (generalized estimating equations). Domain X EV Level X Group interaction tested.|We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).|||||.008
71906394|NCT00738374|143335154|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Chi-squared|||Analysis compared responders and non-responders.||||0.0008
71858027|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.06|TWO_SIDED||||||Regression, Linear|||Appropriate Response. Change-from-baseline analyses were conducted (post-intervention assessment ratings minus pre-intervention assessment ratings) and compared between intervention groups (Floreo and TAU).||||.06
71858028|NCT03605368|143230725|EQUIVALENCE|Simple linear models ('lm' in R) were conducted. Statistical significance was set at p\<.05.|Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.14||0.09|TWO_SIDED||||||Regression, Linear|||||||.09
71858029|NCT03605368|143230726|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|2.67||0.55|TWO_SIDED||||||Regression, Linear|||||||.55
71858030|NCT03605368|143230726|EQUIVALENCE|A linear regression compared change in Police Interaction Knowledge scores by group (Floreo vs. TAU) from pre- to post-intervention. Significance was set at p\<.05.|Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|2.73||0.05|TWO_SIDED||||||Regression, Linear|||||||.05
71858031|NCT00702546|143230727|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-9.4|||||TWO_SIDED|95.0|-19.5|0.7||||||Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (\< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).||0.7|-19.5|
71858032|NCT04088136|143230736|EQUIVALENCE|A one-tailed independent samples t-test was conducted. A p-value of .05 was used to determine statistical significance.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.67|TWO_SIDED|95.0|-0.42|0.55|||t-test, 2 sided|Use of pooled error term, df = 60.|Negative number reflects fewer errors in EMMI group, as predicted.|||0.55|-0.42|.67
71858033|NCT04088136|143230737|SUPERIORITY|Everyday Metacognitive Memory group predicted to have superior scores to Memory Strategy Control|Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.47|TWO_SIDED||||||t-test, 1 sided||pooled error term, equal variance assumption, df = 60|||||<.47
71858034|NCT04088136|143230738|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.0|<|0.13|TWO_SIDED|95.0|-3.7|7.6|||t-test, 1 sided|||||7.6|-3.7|< .13
71858035|NCT04088136|143230739|EQUIVALENCE|Directional hypothesis of fewer errors in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.8||0.57|TWO_SIDED|95.0|-4.8|2.6||A p-value of .05 was used to determine statistical significance.|t-test, 2 sided|Pooled error term, df = 51||||2.6|-4.8|.57
71858036|NCT04088136|143230740|EQUIVALENCE|Two-tailed test of hypothesis of fewer errors in EMMI group|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|2.3||0.72|TWO_SIDED|95.0|-3.8|5.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Pooled error term, df = 49||||5.5|-3.8|.72
71858037|NCT04088136|143230741|OTHER|Test of Group X Time interaction|||||<|0.69|||||||Mixed Models Analysis|pooled df = 59||"We ran a 2 X 2 (Group X Time) mixed model analysis with repeated measures on Time (pretest, posttest).~Hypothesis was that Memory Strategy Control group would show greater improvements from pretest to posttest in recall scores"||||< .69
71858038|NCT04088136|143230742|OTHER|One-tailed test of Group X Time interaction|||||<|0.037|||||||Mixed Models Analysis|||"We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest).~Predicted hypothesis was greater pretest-posttest improvement in the Memory Strategy Contol group"||||< .037
71858039|NCT04088136|143230743|OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|9.9||0.69|TWO_SIDED|95.0|-4.0|8.4|||t-test, 2 sided||one instance of missing data due to computer failure during testing. Pooled error term resulting in df = 59|||8.4|-4.0|.69
71858040|NCT04088136|143230744|EQUIVALENCE|Directional hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|103.3||0.63|TWO_SIDED|95.0|-257.4|157.4||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, DF = 51||||157.4|-257.4|.63
71858041|NCT04088136|143230745|EQUIVALENCE|Two-tailed test of hypothesis of shorter time in Everyday Metacognitive Memory group|Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|43.8||0.81|TWO_SIDED|95.0|-77.4|98.5||A p-value of .05 was used to determine statistical significance|t-test, 2 sided|Use of pooled error term, df = 49||||98.5|-77.4|.81
71858042|NCT04088136|143230746|OTHER||||||<|0.14|||||||Mixed Models Analysis|mixed procedure with unrestricted error covariance matrix. Pooled df for MSWithin = 60||We conducted a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater reduction in memory complaints from pretest to posttest in EMMI group||||< .14
71858043|NCT04088136|143230747|OTHER|||||||0.037|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effect model with repeated measures on Time (pretest-posttest)||||.037
71858044|NCT04088136|143230748|OTHER|Hypothesis was greater increase in memory self-efficacy for Everyday Metacognitive Memory group|||||<|0.33|||||||Mixed Models Analysis|mixed model specified unrestricted residual (error) covariance matrix. Pooled df in MS Error = 60||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest).||||< .33
71858045|NCT04088136|143230749|OTHER||||||<|0.2|||||||Mixed Models Analysis|||We ran a 2 X 2 (Group X Time) mixed effects model with repeated measures on Time (pretest, posttest). Hypothesis was greater increase in memory control in EMMI group||||< .20
71858046|NCT04088136|143230750|OTHER|Hypothesis was greater increase in use of external mnemonics in EMMI group|||||<|0.2|||||||Mixed Models Analysis|||||||< .20
71906395|NCT00738374|143335155|SUPERIORITY_OR_OTHER|||||||0.0795|TWO_SIDED||||||Chi-squared|||||||0.0795
71906396|NCT00738374|143335171|SUPERIORITY_OR_OTHER|||||||0.2712|TWO_SIDED||||||Log Rank|||||||0.2712
71906397|NCT03334396|143335174|SUPERIORITY||Odds Ratio (OR)|2.61||||0.02|TWO_SIDED|95.0|1.17|5.84|||Regression, Logistic|||||5.84|1.17|0.020
71906398|NCT03334396|143335174|SUPERIORITY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|1.93|8.7|||Regression, Logistic|||||8.70|1.93|<0.001
71906399|NCT03334396|143335175|SUPERIORITY||Odds Ratio (OR)|2.72||||0.014|TWO_SIDED|95.0|1.23|6.01|||Regression, Logistic|||||6.01|1.23|0.014
71906400|NCT03334396|143335176|SUPERIORITY||Odds Ratio (OR)|2.03||||0.032|TWO_SIDED|95.0|1.06|3.88|||Regression, Logistic|||||3.88|1.06|0.032
71906401|NCT03334396|143335176|SUPERIORITY||Odds Ratio (OR)|2.46||||0.006|TWO_SIDED|95.0|1.29|4.67|||Regression, Logistic|||||4.67|1.29|0.006
71858047|NCT02979613|143230754|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|2.0|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.||2.0|-1.9|
71858048|NCT02979613|143230755|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-1.9|1.9|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||1.9|-1.9|
71858049|NCT02979613|143230755|SUPERIORITY|||||||0.9953||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.9953
71858050|NCT02979613|143230756|NON_INFERIORITY|Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||TWO_SIDED|95.0|-3.7|3.7|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||3.7|-3.7|
71858051|NCT02979613|143230756|SUPERIORITY|||||||0.98||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.98
71858052|NCT02979613|143230758|NON_INFERIORITY|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.9|||||TWO_SIDED|95.0|-3.5|5.2|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||5.2|-3.5|
71858053|NCT02979613|143230758|SUPERIORITY|||||||0.6863||||||P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.|Cochran-Mantel-Haenszel|||||||0.6863
71858054|NCT02979613|143230760|SUPERIORITY||Difference in the Percentages|1.4||||0.7258|TWO_SIDED|95.0|-7.2|10.1||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||10.1|-7.2|0.7258
71858055|NCT02979613|143230761|SUPERIORITY||Difference in the Percentages|2.7||||0.1348|TWO_SIDED|95.0|-2.3|7.7||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||7.7|-2.3|0.1348
71858056|NCT02979613|143230762|SUPERIORITY||Difference in the Percentages|9.0||||0.1005|TWO_SIDED|95.0|-2.0|20.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||20.1|-2.0|0.1005
71858057|NCT02979613|143230763|SUPERIORITY||Difference in the Percentages|2.5||||0.4154|TWO_SIDED|95.0|-4.5|9.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.|||9.5|-4.5|0.4154
71858058|NCT02979613|143230764|SUPERIORITY||Difference in the Percentages|-2.0||||0.0281|TWO_SIDED|95.0|-4.4|0.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||0.3|-4.4|0.0281
71858059|NCT02979613|143230766|SUPERIORITY||Difference in the Percentages|-0.8||||0.5373|TWO_SIDED|95.0|-3.7|2.1||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.1|-3.7|0.5373
71858060|NCT02979613|143230767|SUPERIORITY||Difference in the Percentages|0.4||||0.5845|TWO_SIDED|95.0|-1.7|2.5||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|||2.5|-1.7|0.5845
71858061|NCT02979613|143230768|SUPERIORITY||Difference in the Percentages|4.5||||0.1405|TWO_SIDED|95.0|-1.6|10.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||10.6|-1.6|0.1405
71906402|NCT03334396|143335176|SUPERIORITY||Odds Ratio (OR)|3.72|||<|0.001|TWO_SIDED|95.0|2.01|6.89|||Regression, Logistic|||||6.89|2.01|<0.001
71906403|NCT03334396|143335177|SUPERIORITY||Odds Ratio (OR)|1.73||||0.21|TWO_SIDED|95.0|0.74|4.05|||Regression, Logistic|||||4.05|0.74|0.210
71906404|NCT03334396|143335177|SUPERIORITY||Odds Ratio (OR)|2.5||||0.029|TWO_SIDED|95.0|1.1|5.7|||Regression, Logistic|||||5.70|1.10|0.029
71906405|NCT03334396|143335177|SUPERIORITY||Odds Ratio (OR)|4.13|||<|0.001|TWO_SIDED|95.0|1.91|8.91|||Regression, Logistic|||||8.91|1.91|<0.001
71858062|NCT02979613|143230768|SUPERIORITY||Difference in the Percentages|3.8||||0.3133|TWO_SIDED|95.0|-3.7|11.4||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||11.4|-3.7|0.3133
71858063|NCT02979613|143230769|SUPERIORITY||Difference in the Percentages|14.1||||0.3381|TWO_SIDED|95.0|-16.4|44.6||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory criteria||44.6|-16.4|0.3381
71858064|NCT02979613|143230769|SUPERIORITY||Difference in the Percentages|23.8||||0.0136|TWO_SIDED|95.0|5.3|42.3||P-value was from the CMH test, stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||42.3|5.3|0.0136
71858065|NCT02979613|143230770|SUPERIORITY||Difference in the Percentages|-2.9||||0.2803|TWO_SIDED|95.0|-8.4|2.6||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||2.6|-8.4|0.2803
71858066|NCT02979613|143230770|SUPERIORITY||Difference in the Percentages|-5.9||||0.0788|TWO_SIDED|95.0|-12.6|0.7||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.7|-12.6|0.0788
71858067|NCT02979613|143230771|SUPERIORITY||Difference in the Percentages|-23.9||||0.088|TWO_SIDED|95.0|-51.2|3.4||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria||3.4|-51.2|0.0880
71858068|NCT02979613|143230771|SUPERIORITY||Difference in the Percentages|-18.6||||0.051|TWO_SIDED|95.0|-37.4|0.2||P-value was from CMH tests stratified by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (\< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria||0.2|-37.4|0.0510
71858069|NCT02979613|143230772|SUPERIORITY||Difference in LSM|-0.02||||0.0186|TWO_SIDED|95.0|-0.03|0.0|||ANOVA|||P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (\< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.00|-0.03|0.0186
71858070|NCT02979613|143230773|SUPERIORITY||Difference in LSM|0.0||||0.6956|TWO_SIDED|95.0|-0.02|0.01|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||0.01|-0.02|0.6956
71858071|NCT02979613|143230774|SUPERIORITY||Difference in LSM|1.167|||<|0.0001|TWO_SIDED|95.0|0.797|1.536|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.536|0.797|< 0.0001
71858072|NCT02979613|143230775|SUPERIORITY||Difference in LSM|0.977||||0.0002|TWO_SIDED|95.0|0.465|1.49|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.490|0.465|0.0002
71858073|NCT02979613|143230776|SUPERIORITY||Difference in LSM|1.881|||<|0.0001|TWO_SIDED|95.0|1.275|2.486|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||2.486|1.275|< 0.0001
71858074|NCT02979613|143230777|SUPERIORITY||Difference in LSM|0.604||||0.097|TWO_SIDED|95.0|-0.11|1.317|||ANOVA|||P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (\<50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.||1.317|-0.110|0.0970
71858075|NCT02979613|143230778|SUPERIORITY||||||<|0.0001||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||< 0.0001
71858076|NCT02979613|143230779|SUPERIORITY|||||||0.7535||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test|||||||0.7535
71858077|NCT00092521|143230780|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|95.1|100.0|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter|||100|95.1|
71858078|NCT00092521|143230781|SUPERIORITY_OR_OTHER||Percent relative risk reduction|100.0||||||95.0|94.9|100.0|||||CI based on binomial tail probabilities and not from a dispersion parameter|||100|94.9|
71858079|NCT01878383|143230782|OTHER|Sensitivity is the percent of non-pregnant women positive for shedding HSV by culture method in which GeneXpert test results is positive. Units equals percent non-pregnant women positive.|Sensitivity|100.0|||||TWO_SIDED|95.0|90.8|100.0|||||95% Clopper-Pearson Exact Confidence Interval|||100|90.8|
71858080|NCT01878383|143230783|OTHER|Positive percent agreement is the percent of pregnant women with positive routine PCR results in which GeneXpert test results is positive. Units equal percent of pregnant women positive.|Positive percent agreement|80.0|||||TWO_SIDED|95.0|73.7|86.3|||||95% large sample confidence interval|||86.3|73.7|
71858081|NCT01878383|143230784|OTHER|Negative percent agreement is the percent of pregnant women with negative routine PCR results in which GeneXpert test results is negative. Units equal percent of pregnant women negative.|Negative percent agreement|99.2|||||TWO_SIDED|95.0|99.0|99.5|||||95% large sample confidence interval|||99.5|99|
71858082|NCT02161406|143230849|SUPERIORITY|||||||0.28|||||||Mixed Models Analysis|||||||0.28
71858083|NCT02161406|143230850|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
71858084|NCT02161406|143230851|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71858085|NCT02161406|143230852|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71858086|NCT02161406|143230853|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
71858087|NCT02161406|143230854|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
71858088|NCT02161406|143230855|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||0.19
71906406|NCT03334396|143335178|SUPERIORITY||Mean Difference (Final Values)|-13.4|STANDARD_ERROR_OF_MEAN|5.78||0.021|TWO_SIDED|95.0|-24.77|-2.03|||Mixed Models Analysis|||||-2.03|-24.77|0.021
71906407|NCT03334396|143335178|SUPERIORITY||Mean Difference (Final Values)|-17.07|STANDARD_ERROR_OF_MEAN|5.57||0.002|TWO_SIDED|95.0|-28.05|-6.1|||Mixed Models Analysis|||||-6.10|-28.05|0.002
71906408|NCT03334396|143335178|SUPERIORITY||Mean Difference (Final Values)|-24.54|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-34.84|-14.24|||Mixed Models Analysis|||||-14.24|-34.84|<0.001
71858089|NCT02161406|143230856|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
71858090|NCT02161406|143230857|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71906409|NCT03334396|143335179|SUPERIORITY||Odds Ratio (OR)|4.28||||0.025|TWO_SIDED|95.0|1.2|15.24|||Regression, Logistic|||||15.24|1.20|0.025
71906410|NCT03334396|143335179|SUPERIORITY||Odds Ratio (OR)|6.14||||0.004|TWO_SIDED|95.0|1.79|20.99|||Regression, Logistic|||||20.99|1.79|0.004
71858091|NCT02161406|143230858|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|||||||0.12
71858092|NCT02161406|143230859|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
71858093|NCT02161406|143230860|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||||||0.37
71858094|NCT02161406|143230861|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.55
71858095|NCT02161406|143230862|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
71858096|NCT02161406|143230863|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71858097|NCT02161406|143230864|SUPERIORITY|||||||0.81|||||||Mixed Models Analysis|||||||0.81
71858098|NCT02161406|143230865|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71858099|NCT02161406|143230866|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
71858100|NCT02161406|143230867|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||||||0.13
71858101|NCT02161406|143230868|SUPERIORITY|||||||0.92|||||||Mixed Models Analysis|||||||0.92
71858102|NCT02161406|143230869|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
71858103|NCT02161406|143230870|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71858104|NCT02161406|143230871|SUPERIORITY|||||||0.03|||||||van Elteren test|The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.||||||0.03
71858105|NCT02161406|143230872|SUPERIORITY|||||||0.1769|||||||Mixed Models Analysis|||||||0.1769
71858106|NCT02161406|143230873|SUPERIORITY|||||||0.9075|||||||Mixed Models Analysis|||||||0.9075
71858107|NCT02161406|143230874|SUPERIORITY|||||||0.5831|||||||Mixed Models Analysis|||||||0.5831
71858108|NCT02161406|143230875|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|||||||0.0193
71858109|NCT02161406|143230876|SUPERIORITY|||||||0.0097|||||||Mixed Models Analysis|||||||0.0097
71858110|NCT02161406|143230877|SUPERIORITY|||||||0.0751|||||||Mixed Models Analysis|||||||0.0751
71858111|NCT02161406|143230878|SUPERIORITY|||||||0.4927|||||||Mixed Models Analysis|||||||0.4927
71858112|NCT02161406|143230879|SUPERIORITY|||||||0.1604|||||||Mixed Models Analysis|||||||0.1604
71858113|NCT02161406|143230880|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
71858114|NCT02161406|143230881|SUPERIORITY|||||||0.1679|||||||Mixed Models Analysis|||||||0.1679
71858115|NCT02161406|143230882|SUPERIORITY|||||||0.2906|||||||Mixed Models Analysis|||||||0.2906
71906411|NCT03334396|143335179|SUPERIORITY||Odds Ratio (OR)|8.76|||<|0.001|TWO_SIDED|95.0|2.68|28.58|||Regression, Logistic|||||28.58|2.68|<0.001
71906412|NCT03334396|143335180|SUPERIORITY||Odds Ratio (OR)|1.6||||0.246|TWO_SIDED|95.0|0.72|3.56|||Regression, Logistic|||||3.56|0.72|0.246
71906413|NCT03334396|143335180|SUPERIORITY||Odds Ratio (OR)|1.73||||0.169|TWO_SIDED|95.0|0.79|3.77|||Regression, Logistic|||||3.77|0.79|0.169
71906414|NCT03334396|143335180|SUPERIORITY||Odds Ratio (OR)|3.62|||<|0.001|TWO_SIDED|95.0|1.82|7.18|||Regression, Logistic|||||7.18|1.82|<0.001
71906415|NCT03334396|143335181|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.103|TWO_SIDED|95.0|-0.82|0.08|||Mixed Models Analysis|||||0.08|-0.82|0.103
71906416|NCT03334396|143335181|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.352|TWO_SIDED|95.0|-0.65|0.23|||Mixed Models Analysis|||||0.23|-0.65|0.352
71906417|NCT03334396|143335181|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.006|TWO_SIDED|95.0|-1.0|-0.17|||Mixed Models Analysis|||||-0.17|-1.00|0.006
71906418|NCT03334396|143335182|SUPERIORITY||Mean Difference (Final Values)|-1.08||||0.005|TWO_SIDED|95.0|-1.84|-0.32|||Mixed Models Analysis|||||-0.32|-1.84|0.005
71906419|NCT03334396|143335182|SUPERIORITY||Mean Difference (Final Values)|-0.74||||0.051|TWO_SIDED|95.0|-1.48|0.0|||Mixed Models Analysis|||||0.00|-1.48|0.051
71858116|NCT00760513|143230889|SUPERIORITY||Mean Difference (Net)|-1.7||||0.48|TWO_SIDED|95.0|-6.3|3.0||The a priori threshold for statistical significance = P\</=0.05|Regression, Linear|Adjusted for baseline value of liver fat percentage||We estimated that a 20% decrease in liver fat with Omacor treatment, assuming a sigma of 0.3, and an alpha of 0.05; with 91 participants completing our trial, we had 86% power to detect a 20% change in liver fat (two tailed test) (see HEPATOLOGY 2014;60:1211-1221).||3.0|-6.3|0.48
71858117|NCT00760513|143230890|SUPERIORITY||Mean Difference (Net)|-0.001||||1|TWO_SIDED|95.0|-0.3|0.3||A priori p value threshold \</=0.5|Regression, Linear|Adjusted for baseline||Based on the available evidence at the time, we assumed that a 0.6-1.0 unit change in fibrosis score might be clinically significant (Hepatology 2008 Feb;47(2):455-460). Consequently, to detect a minimum 0.6 unit change in score (e.g. 9.0 at baseline and 8.4 at the end of the study) with an SD of 1.0, 100 participants would provide \>80% power at the 5% significance level, and with a 15% drop out of participants there would also be \>80% power to detect this effect.||0.3|-0.3|1.0
71858118|NCT00760513|143230891|SUPERIORITY||Mean Difference (Net)|-0.03||||0.9|TWO_SIDED|95.0|-0.4|0.3||A priori threshold for statistical significance p \</=0.05|Regression, Linear|Adjusted for baseline measurement.||There was no power calculation for this end point.||0.3|-0.4|0.9
71858119|NCT00362375|143230912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.05|TWO_SIDED|95.0|1.28|4.5|||Generalized Estimating Equation|||GEE cluster-adjusted odds ratio||4.50|1.28|<0.05
71858120|NCT00362375|143230913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48|||<|0.05|TWO_SIDED|95.0|0.2|1.16|||GEE|||||1.16|0.20|<0.05
71858121|NCT00362375|143230914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39|||<|0.05|TWO_SIDED|95.0|0.99|1.95|||GEE|||||1.95|0.99|<0.05
71858122|NCT00362375|143230915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07|||<|0.05|TWO_SIDED|95.0|0.8|1.44|||GEE|GEE incident rate ratio||||1.44|0.80|<0.05
71906420|NCT03334396|143335182|SUPERIORITY||Mean Difference (Final Values)|-1.09||||0.002|TWO_SIDED|95.0|-1.79|-0.39|||Mixed Models Analysis|||||-0.39|-1.79|0.002
71906421|NCT03334396|143335183|SUPERIORITY||Odds Ratio (OR)|1.9||||0.019|TWO_SIDED|95.0|1.11|3.25|||Regression, Logistic|||||3.25|1.11|0.019
71858123|NCT00362375|143230916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||<|0.05|TWO_SIDED|95.0|0.76|2.71|||GEE|||||2.71|0.76|<0.05
71858124|NCT03491215|143230954|OTHER|Comparison|GMR|0.801|||||TWO_SIDED|90.0|0.49|1.311||||||Group 3 vs Group 2||1.311|0.490|
71858125|NCT03491215|143230954|OTHER|Comparison|GMR|0.991|||||TWO_SIDED|90.0|0.532|1.846||||||Group 3 vs. Group 1||1.846|0.532|
71858126|NCT03491215|143230954|OTHER|Comparison|GMR|1.237|||||TWO_SIDED|90.0|0.639|2.394||||||Group 2 vs. Group 1||2.394|0.639|
71906422|NCT03334396|143335183|SUPERIORITY||Mean Difference (Final Values)|2.44|||<|0.001|TWO_SIDED|95.0|1.44|4.14|||Regression, Logistic|||||4.14|1.44|<0.001
71906423|NCT03334396|143335183|SUPERIORITY||Mean Difference (Final Values)|4.18|||<|0.001|TWO_SIDED|95.0|2.51|6.96|||Regression, Logistic|||||6.96|2.51|<0.001
71906424|NCT03334396|143335184|SUPERIORITY||Odds Ratio (OR)|1.98||||0.424|TWO_SIDED|95.0|0.37|10.63|||Regression, Logistic|||||10.63|0.37|0.424
71858127|NCT03491215|143230955|OTHER|Comparison|GMR|0.709|||||TWO_SIDED|90.0|0.425|1.184||||||Group 3 vs. Group 2||1.184|0.425|
71858128|NCT03491215|143230955|OTHER|Comparison|GMR|0.968|||||TWO_SIDED|90.0|0.506|1.851||||||Group 3 vs. Group 1||1.851|0.506|
71858129|NCT03491215|143230955|OTHER|Comparison|GMR|1.365|||||TWO_SIDED|90.0|0.686|2.714||||||Group 2 vs. Group 1||2.714|0.686|
71858130|NCT03491215|143230957|OTHER|Comparison|GMR|0.759|||||TWO_SIDED|90.0|0.245|2.352||||||Group 3 vs. Group 2||2.352|0.245|
71858131|NCT03491215|143230957|OTHER|Comparison|GMR|0.516|||||TWO_SIDED|90.0|0.15|1.784||||||Group 3 vs. Group 1||1.784|0.150|
71858132|NCT03491215|143230957|OTHER|Comparison|GMR|0.681|||||TWO_SIDED|90.0|0.178|2.597||||||Group 2 vs. Group 1||2.597|0.178|
71858133|NCT03491215|143230965|SUPERIORITY||Odds Ratio (OR)|0.976|||||TWO_SIDED|95.0|0.858|1.109||||||||1.109|0.858|
71858134|NCT03491215|143230965|SUPERIORITY||Odds Ratio (OR)|0.951|||||TWO_SIDED|95.0|0.735|1.232||||||||1.232|0.735|
71858135|NCT03491215|143230966|SUPERIORITY||Hazard Ratio (HR)|1.014|||||TWO_SIDED|95.0|0.921|1.115||||||||1.115|0.921|
71858136|NCT03491215|143230966|SUPERIORITY||Hazard Ratio (HR)|1.029|||||TWO_SIDED|95.0|0.841|1.258||||||||1.258|0.841|
71858137|NCT03491215|143230967|SUPERIORITY||Hazard Ratio (HR)|1.063|||||TWO_SIDED|95.0|1.012|1.117||||||||1.117|1.012|
71858138|NCT03491215|143230967|SUPERIORITY||Hazard Ratio (HR)|1.132|||||TWO_SIDED|95.0|1.025|1.25||||||||1.25|1.025|
71858139|NCT00337285|143230990|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
71858140|NCT00337285|143230992|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||< 0.0001
71858141|NCT01101997|143231012|SUPERIORITY||sucess proportion|0.853|||<|0.001|TWO_SIDED|95.0|0.773|0.91|||Chi-squared|||H0: p= 0.6 and Ha: p ≠ 0.6||.910|.773|<0.001
71858142|NCT01101997|143231013|OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|2.49|||TWO_SIDED|||||||||||||
71858143|NCT01983553|143231015|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.93|||||TWO_SIDED|95.0|0.64|1.36|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Any of the 4 Serotypes||1.36|0.64|
71906425|NCT03334396|143335184|SUPERIORITY||Odds Ratio (OR)|2.89||||0.182|TWO_SIDED|95.0|0.61|13.75|||Regression, Logistic|||||13.75|0.61|0.182
71906426|NCT03334396|143335184|SUPERIORITY||Odds Ratio (OR)|1.94||||0.441|TWO_SIDED|95.0|0.36|10.41|||Regression, Logistic|||||10.41|0.36|0.441
71906427|NCT03334396|143335185|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|3.17||0.093|TWO_SIDED|95.0|-11.57|0.9|||Mixed Models Analysis|||||0.90|-11.57|0.093
71906428|NCT03334396|143335185|SUPERIORITY||Mean Difference (Final Values)|-7.97|STANDARD_ERROR_OF_MEAN|3.07||0.01|TWO_SIDED|95.0|-14.01|-1.92|||Mixed Models Analysis|||||-1.92|-14.01|0.010
71906429|NCT03334396|143335185|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-20.46|-9.13|||Mixed Models Analysis|||||-9.13|-20.46|<0.001
71906430|NCT03334396|143335186|SUPERIORITY||Odds Ratio (OR)|1.17||||0.874|TWO_SIDED|95.0|0.17|7.77|||Regression, Logistic|||||7.77|0.17|0.874
71906431|NCT03334396|143335186|SUPERIORITY||Odds Ratio (OR)|2.88||||0.176|TWO_SIDED|95.0|0.62|13.36|||Regression, Logistic|||||13.36|0.62|0.176
71858144|NCT01983553|143231015|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.96|||||TWO_SIDED|95.0|0.44|2.21|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 1||2.21|0.44|
71858145|NCT01983553|143231015|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.326|||||TWO_SIDED|95.0|0.64|2.94|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 2||2.94|0.64|
71858146|NCT01983553|143231015|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.056|||||TWO_SIDED|95.0|0.48|2.51|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 3||2.51|0.48|
71906432|NCT03334396|143335186|SUPERIORITY||Odds Ratio (OR)|2.72||||0.201|TWO_SIDED|95.0|0.59|12.65|||Regression, Logistic|||||12.65|0.59|0.201
71906433|NCT03334396|143335187|SUPERIORITY||Mean Difference (Final Values)|-5.99|STANDARD_ERROR_OF_MEAN|2.88||0.039|TWO_SIDED|95.0|-11.67|-0.31|||Mixed Models Analysis|||||-0.31|-11.67|0.039
71906434|NCT03334396|143335187|SUPERIORITY||Mean Difference (Final Values)|-5.34|STANDARD_ERROR_OF_MEAN|2.8||0.058|TWO_SIDED|95.0|-10.86|0.18|||Mixed Models Analysis|||||0.18|-10.86|0.058
71906435|NCT03334396|143335187|SUPERIORITY||Mean Difference (Final Values)|-11.16|STANDARD_DEVIATION|2.63|<|0.001|TWO_SIDED|95.0|-16.33|-5.98|||Mixed Models Analysis|||||-5.98|-16.33|<0.001
71906436|NCT03334396|143335188|SUPERIORITY|||||||0.067|||||||Fisher Exact|||||||0.067
71906437|NCT03334396|143335188|SUPERIORITY|||||||0.799|||||||Fisher Exact|||||||0.799
71906438|NCT03334396|143335188|SUPERIORITY|||||||0.782|||||||Fisher Exact|||||||0.782
71906439|NCT03334396|143335189|SUPERIORITY||Mean Difference (Final Values)|-19.25|STANDARD_ERROR_OF_MEAN|7.33||0.009|TWO_SIDED|95.0|-33.69|-4.81|||Mixed Models Analysis|||||-4.81|-33.69|0.009
71906440|NCT03334396|143335189|SUPERIORITY||Mean Difference (Final Values)|-17.39|STANDARD_ERROR_OF_MEAN|7.13||0.015|TWO_SIDED|95.0|-31.43|-3.35|||Mixed Models Analysis|||||-3.35|-31.43|0.015
71906441|NCT03334396|143335189|SUPERIORITY||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|6.71|<|0.001|TWO_SIDED|95.0|-37.71|-11.3|||Mixed Models Analysis|||||-11.30|-37.71|<0.001
71858147|NCT01983553|143231015|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.629|||||TWO_SIDED|95.0|0.27|1.47|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 4||1.47|0.27|
71858148|NCT01983553|143231015|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|1.22|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Unserotyped||1.22|0.00|
71906442|NCT03334396|143335190|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|1.19||0.028|TWO_SIDED|95.0|-4.98|-0.29|||Mixed Models Analysis|||||-0.29|-4.98|0.028
71906443|NCT03334396|143335190|SUPERIORITY||Mean Difference (Final Values)|-3.58|STANDARD_ERROR_OF_MEAN|1.17||0.003|TWO_SIDED|95.0|-5.89|-1.27|||Mixed Models Analysis|||||-1.27|-5.89|0.003
71906444|NCT03334396|143335190|SUPERIORITY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-7.33|-2.99|||Mixed Models Analysis|||||-2.99|-7.33|<0.001
71906445|NCT03334396|143335191|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.069|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.069
71906446|NCT03334396|143335191|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.066|TWO_SIDED|95.0|-0.56|0.02|||Mixed Models Analysis|||||0.02|-0.56|0.066
71906447|NCT03334396|143335191|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.73|-0.19|||Mixed Models Analysis|||||-0.19|-0.73|<0.001
71906448|NCT03334396|143335192|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.43||0.305|TWO_SIDED|95.0|-1.3|0.41|||Mixed Models Analysis|||HADS Anxiety||0.41|-1.30|0.305
71906449|NCT03334396|143335192|SUPERIORITY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.77|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.77|0.029
71906450|NCT03334396|143335192|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.004|TWO_SIDED|95.0|-1.93|-0.36|||Mixed Models Analysis|||HADS Anxiety||-0.36|-1.93|0.004
71906451|NCT03334396|143335192|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.113|TWO_SIDED|95.0|-1.51|0.16|||Mixed Models Analysis|||HADS Depression||0.16|-1.51|0.113
71906452|NCT03334396|143335192|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.42||0.014|TWO_SIDED|95.0|-1.85|-0.22|||Mixed Models Analysis|||HADS Depression||-0.22|-1.85|0.014
71906453|NCT03334396|143335192|SUPERIORITY||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.39||0.004|TWO_SIDED|95.0|-1.91|-0.37|||Mixed Models Analysis|||HADS Depression||-0.37|-1.91|0.004
71906454|NCT03334396|143335193|SUPERIORITY||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.89||0.015|TWO_SIDED|95.0|-3.92|-0.42|||Mixed Models Analysis|||||-0.42|-3.92|0.015
71906455|NCT03334396|143335193|SUPERIORITY||Mean Difference (Final Values)|-1.84|STANDARD_ERROR_OF_MEAN|0.87||0.036|TWO_SIDED|95.0|-3.56|-0.12|||Mixed Models Analysis|||||-0.12|-3.56|0.036
71906456|NCT03334396|143335193|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|0.82|<|0.001|TWO_SIDED|95.0|-5.91|-2.69|||Mixed Models Analysis|||||-2.69|-5.91|<0.001
71906457|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-4.05|STANDARD_ERROR_OF_MEAN|2.7||0.136|TWO_SIDED|95.0|-9.39|1.29|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.29|-9.39|0.136
71906458|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|2.76||0.898|TWO_SIDED|95.0|-5.81|5.1|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||5.10|-5.81|0.898
71906459|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|2.49||0.174|TWO_SIDED|95.0|-8.32|1.52|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||1.52|-8.32|0.174
71858149|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.411|||||TWO_SIDED|95.0|0.64|3.42|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Any Serotype||3.42|0.64|
71858150|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.807|||||TWO_SIDED|95.0|0.53|1.25|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Any Serotype||1.25|0.53|
71858151|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|4.885|||||TWO_SIDED|95.0|0.7|212.02|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 1||212.02|0.70|
71858152|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.557|||||TWO_SIDED|95.0|0.21|1.46|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 1||1.46|0.21|
71858153|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|2.931|||||TWO_SIDED|95.0|0.36|134.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 2||134.83|0.36|
71858154|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.165|||||TWO_SIDED|95.0|0.53|2.74|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 2||2.74|0.53|
71858155|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.221|||||TWO_SIDED|95.0|0.2|12.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 3||12.83|0.20|
71858156|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.013|||||TWO_SIDED|95.0|0.41|2.73|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 3||2.73|0.41|
71906460|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-6.86|STANDARD_ERROR_OF_MEAN|4.19||0.104|TWO_SIDED|95.0|-15.13|1.41|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||1.41|-15.13|0.104
71906461|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-8.64|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.09|-0.19|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-0.19|-17.09|0.045
71906462|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-12.28|STANDARD_ERROR_OF_MEAN|3.9||0.002|TWO_SIDED|95.0|-19.97|-4.59|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-4.59|-19.97|0.002
71858157|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.977|||||TWO_SIDED|95.0|0.21|6.04|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 4||6.04|0.21|
71858158|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.506|||||TWO_SIDED|95.0|0.18|1.44|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 4||1.44|0.18|
71906463|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-8.66|STANDARD_ERROR_OF_MEAN|4.67||0.066|TWO_SIDED|95.0|-17.89|0.57|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||0.57|-17.89|0.066
71906464|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-6.49|STANDARD_ERROR_OF_MEAN|4.76||0.175|TWO_SIDED|95.0|-15.89|2.91|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.91|-15.89|0.175
71906465|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-11.28|STANDARD_ERROR_OF_MEAN|4.34||0.01|TWO_SIDED|95.0|-19.84|-2.72|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||-2.72|-19.84|0.010
71906466|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-7.31|STANDARD_ERROR_OF_MEAN|3.36||0.03|TWO_SIDED|95.0|-13.93|-0.7|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-0.70|-13.93|0.030
71906467|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-5.13|STANDARD_ERROR_OF_MEAN|3.31||0.122|TWO_SIDED|95.0|-11.65|1.39|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||1.39|-11.65|0.122
71906468|NCT03334396|143335194|SUPERIORITY||Mean Difference (Final Values)|-16.52|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-22.64|-10.41|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-10.41|-22.64|<0.001
71906469|NCT03334396|143335195|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.061|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.061
71906470|NCT03334396|143335195|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.06|TWO_SIDED|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.08|-0.00|0.060
71906471|NCT03334396|143335195|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.04|0.12|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.12|0.04|<0.001
71906472|NCT03334396|143335195|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.046|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|0.00|0.046
71906473|NCT03334396|143335195|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.059|TWO_SIDED|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.11|-0.00|0.059
71906474|NCT03334396|143335195|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.06|0.16|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.16|0.06|<0.001
71906475|NCT03334396|143335196|SUPERIORITY||Mean Difference (Final Values)|2.97|STANDARD_ERROR_OF_MEAN|3.21||0.356|TWO_SIDED|95.0|-3.36|9.3|||Mixed Models Analysis|||EQ-5D-5L VAS Score||9.30|-3.36|0.356
71906476|NCT03334396|143335196|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|3.13||0.668|TWO_SIDED|95.0|-4.81|7.5|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.50|-4.81|0.668
71906477|NCT03334396|143335196|SUPERIORITY||Mean Difference (Final Values)|7.05|STANDARD_ERROR_OF_MEAN|2.95||0.017|TWO_SIDED|95.0|1.25|12.86|||Mixed Models Analysis|||EQ-5D-5L VAS Score||12.86|1.25|0.017
71906478|NCT03334396|143335197|SUPERIORITY||Odds Ratio (OR)|1.38||||0.603|TWO_SIDED|95.0|0.41|4.71|||Regression, Logistic|||||4.71|0.41|0.603
71906479|NCT03334396|143335197|SUPERIORITY||Odds Ratio (OR)|4.08||||0.006|TWO_SIDED|95.0|1.5|11.12|||Regression, Logistic|||||11.12|1.50|0.006
71906480|NCT03334396|143335197|SUPERIORITY||Odds Ratio (OR)|4.72||||0.002|TWO_SIDED|95.0|1.78|12.55|||Regression, Logistic|||||12.55|1.78|0.002
71906481|NCT01927419|143335244|SUPERIORITY||Mean Difference (Final Values)|49.5|||||TWO_SIDED|95.0|31.4|61.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|61.8|31.4|
71906482|NCT01927419|143335244|SUPERIORITY||Odds Ratio (OR)|12.52|||||TWO_SIDED|95.0|3.79|52.55|||Fisher Exact|||||52.55|3.79|
71906483|NCT01927419|143335245|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.21|0.59|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.59|0.21|
71906484|NCT01927419|143335246|SUPERIORITY||Mean Difference (Final Values)|44.5|||||TWO_SIDED|95.0|8.2|64.8|||Fisher Exact||Difference of ORR||Exact 95% CI for difference in ORR uses Newcombe's method|64.8|8.2|
71906485|NCT01927419|143335246|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|1.07|511.89|||Fisher Exact|||||511.89|1.07|
71906486|NCT01927419|143335247|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.14|0.97|||Unstratified Cox proportional hazard||Nivolumab + Ipilimumab over Ipilimumab|||0.97|0.14|
71906487|NCT00592553|143335273|OTHER||Least Square (LS) Mean Difference|-30.52|STANDARD_ERROR_OF_MEAN|42.68||0.4756|TWO_SIDED|95.0|-114.8|53.75|||Mixed Models Analysis|||Analysis was performed using mixed model for repeated measures (MMRM) method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (less than \[\<\] 9 years versus \[vs.\] greater than or equal to \[\>=\] 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||53.75|-114.8|0.4756
71906488|NCT00592553|143335273|OTHER||LS Mean Difference|62.65|STANDARD_ERROR_OF_MEAN|43.21||0.149|TWO_SIDED|95.0|-22.66|147.96|||Mixed Models Analysis|||Analysis was performed using MMRM method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (\< 9 years vs. \>= 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.||147.96|-22.66|0.1490
71906489|NCT01244191|143335307|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.8086|TWO_SIDED|95.0|0.841|1.149|||Log Rank||Hazard ratio and the 95% confidence interval from stratified Cox-regression model (adjusting for number of prior therapies, gender, and smoking history).|||1.149|0.841|0.8086
71906490|NCT01511107|143335318|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.172|STANDARD_DEVIATION|0.039|||TWO_SIDED|95.0|-0.253|-0.091||||||The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.||-.091|-.253|
71906491|NCT01511107|143335319|NON_INFERIORITY_OR_EQUIVALENCE|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.096|STANDARD_DEVIATION|0.053|||TWO_SIDED|95.0|-0.209|0.016||||||||.016|-.209|
71906492|NCT01511107|143335320|SUPERIORITY_OR_OTHER|||||||0.45|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.45
71906493|NCT01511107|143335321|SUPERIORITY_OR_OTHER|||||||0.95|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.95
71906494|NCT01511107|143335322|SUPERIORITY_OR_OTHER|||||||0.59|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.59
71906495|NCT01511107|143335323|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||>0.99
71681231|NCT00772005|142881173|SUPERIORITY_OR_OTHER|||||||0.0974||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0974
71858159|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.6|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Unserotyped||2.60|0.00|
71858160|NCT01983553|143231018|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.75|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Unserotyped||19.75|0.00|
71858161|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.174|||||TWO_SIDED|95.0|0.27|7.03|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Any grade||7.03|0.27|
71858162|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade I||4.83|0.00|
71858163|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|2.012|||||TWO_SIDED|95.0|0.2|99.1|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade II||99.10|0.20|
71681232|NCT00772005|142881173|SUPERIORITY_OR_OTHER|||||||0.664||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6640
71858164|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Any grade||39.49|0.01|
71858165|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Grade I||39.49|0.01|
71858166|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||TWO_SIDED|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Any grade||4.83|0.00|
71906496|NCT01511107|143335324|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.||||0.47
71681233|NCT00772005|142881173|SUPERIORITY_OR_OTHER|||||||0.1507||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1507
71858167|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|19.62|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade I||19.62|0.00|
71858168|NCT01983553|143231026|OTHER|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||TWO_SIDED|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade II||39.49|0.01|
71906497|NCT01511107|143335325|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.||||0.05
71921976|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|95.0|-10.3|0.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||0.6|-10.3|
71858169|NCT00469456|143231036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.07||95.0|-0.1|2.8|||ANCOVA|||The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||2.8|-0.1|0.070
71681234|NCT00772005|142881174|SUPERIORITY_OR_OTHER|||||||0.7649||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7649
71858170|NCT00469456|143231037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.022||95.0|0.9|10.9|||ANCOVA|||The secondary efficacy parameter was change from Baseline at Week 12 in the total score of the Social Communication subscale and Communication of Basic Needs subscale of the ASHA FACS. Missing scores at week 12 were imputed using the last-observation-carried-forward (LOCF) approach.||10.9|0.9|0.022
71858171|NCT03634839|143231057|SUPERIORITY||Mean Difference (Final Values)|-5.184||||0.053|TWO_SIDED||||||t-test, 2 sided|||||||0.053
71858172|NCT03634839|143231058|SUPERIORITY||Mean Difference (Final Values)|-1.881||||0.187|TWO_SIDED||||||t-test, 2 sided|||Outcome analyses will be intent-to-treat and using mixed-effects models with flavor as a within-subject factor. A significant main effect of flavor with greater liking of sweet plus cooling flavor than sweet minus cooling flavor will be considered supportive of our hypotheses.||||0.187
71858173|NCT03634839|143231059|SUPERIORITY||Mean Difference (Final Values)|-0.286||||0.135|TWO_SIDED||||||t-test, 2 sided|||||||0.135
71858174|NCT03634839|143231060|SUPERIORITY||Mean Difference (Final Values)|1.942||||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.210
71858175|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.89|1.33||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.33|0.89|
71906498|NCT01511107|143335326|SUPERIORITY_OR_OTHER|||||||0.58|||||||Regression, Logistic|The p-value is adjusted for the culture result at enrollment.||Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up||||0.58
71906499|NCT01511107|143335327|SUPERIORITY_OR_OTHER|||||||0.74|||||||Generalized estimating equations|||Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.||||0.74
71906500|NCT01511107|143335328|SUPERIORITY_OR_OTHER|||||||0.72|||||||Regression, Logistic|The p-value is adjusted for S pn susceptibility at the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.||||0.72
71858176|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.92|||||TWO_SIDED|95.0|0.75|1.12||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.12|0.75|
71858177|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.03|||||TWO_SIDED|95.0|0.85|1.26||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.26|0.85|
71858178|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.12|||||TWO_SIDED|95.0|0.78|1.61||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.61|0.78|
71858179|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.88|
71858180|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.88|||||TWO_SIDED|95.0|0.69|1.13||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.13|0.69|
71906501|NCT01511107|143335329|SUPERIORITY_OR_OTHER|||||||0.05|||||||Generalized estimating equations|The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence.||||||0.05
71906502|NCT01511107|143335330|SUPERIORITY_OR_OTHER|||||||0.47|||||||Regression, Logistic|The p-value is adjusted for H flu susceptibility at onset of the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.||||0.47
71906503|NCT01511107|143335331|SUPERIORITY_OR_OTHER|||||||0.69|||||||Generalized estimating equations|The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence.||||||0.69
71906504|NCT01511107|143335332|SUPERIORITY_OR_OTHER|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.||||0.16
71858181|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.73|1.31||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.31|0.73|
71858182|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.08|||||TWO_SIDED|95.0|0.86|1.37||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.37|0.86|
71858183|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.78|1.25||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.25|0.78|
71858184|NCT02447432|143231061|NON_INFERIORITY|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.28|||||TWO_SIDED|95.0|0.92|1.8||||||(Synflorix/10Pn\_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn\_4d) should be below a limit of 2-fold for each of the 10 serotypes.||1.80|0.92|
71858185|NCT04198948|143231075|EQUIVALENCE|Sample size calculation was performed using SAS Proc Power procedure for equivalence test in 2x2 crossover design. For an equivalence range of 80-125%, the within-subject coefficient of variation for the AUC values for gliclazide of 7.8% based on previous PK studies, and expected test/reference geometric mean ratios between 87-115%, 14 volunteers (7 individuals per sequence) are required to show the lack of interaction with 85% power.|Geometric least square mean ratio|1.13|||||TWO_SIDED|90.0|0.86|1.48|||||The TOST (two one-sided test) test of equivalence showed that the geometric mean ratio and 90% CI for gliclazide AUC(0-24) between omeprazole and placebo phase was 1.13 (0.86-1.48), with upper confidence limit above the usual 1.25 boundary.|The main evaluated outcome was systemic exposure to gliclazide, expressed as AUC(0-t). The geometric mean was calculated for gliclazide AUC(0-24). The ratio of the geometric means with 90% CIs was assessed by linear mixed models between the two treatment assignments: gliclazide and omeprazole co-administration to that of gliclazide and placebo. The obtained 90% CI was compared with the equivalence 0.8-1.25 range.||1.48|0.86|
71858186|NCT04198948|143231076|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
71858187|NCT04198948|143231077|SUPERIORITY|||||||0.055|||||||t-test, 2 sided|||||||0.055
71858188|NCT00913068|143231079|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Chi-squared|||||||0.0012
71858189|NCT00726713|143231087|SUPERIORITY_OR_OTHER||||||=|0.013|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.013
71858190|NCT00726713|143231087|SUPERIORITY_OR_OTHER||||||=|0.033|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 24||||=0.033
71858191|NCT00726713|143231088|SUPERIORITY_OR_OTHER||||||=|0.027|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16||||=0.027
71858192|NCT00726713|143231089|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 16||||=0.0001
71858193|NCT00726713|143231089|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 24||||=0.0001
71681235|NCT00772005|142881174|SUPERIORITY_OR_OTHER|||||||0.4866||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4866
71858194|NCT00726713|143231089|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from Baseline Week 16||||=0.0001
71858195|NCT00726713|143231089|SUPERIORITY_OR_OTHER||||||=|0.0008|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from BL, Week 24||||=0.0008
71858196|NCT00726713|143231089|SUPERIORITY_OR_OTHER||||||=|0.0001||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Homocysteine, Change from BL, Week 16||||=0.0001
71858197|NCT00726713|143231089|SUPERIORITY_OR_OTHER||||||=|0.0001|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total Homocysteine, Change from BL, Week 24||||=0.0001
71858198|NCT00726713|143231090|SUPERIORITY_OR_OTHER||||||=|0.0306||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||SF-36 MCS, Change from BL, Week 24||||=0.0306
71858199|NCT00726713|143231093|SUPERIORITY_OR_OTHER||||||=|0.054|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||HADS Depression, Change from BL, Week 24||||=0.054
71858200|NCT02367105|143231097|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.58|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariate||||||0.58
71858201|NCT02367105|143231098|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
71681236|NCT00772005|142881174|SUPERIORITY_OR_OTHER|||||||0.5002||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5002
71681237|NCT00772005|142881175|SUPERIORITY_OR_OTHER|||||||0.2076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2076
71681238|NCT00772005|142881175|SUPERIORITY_OR_OTHER|||||||0.9355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9355
71681239|NCT00772005|142881175|SUPERIORITY_OR_OTHER|||||||0.189||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1890
71858202|NCT02367105|143231099|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.97|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||.97
71858203|NCT02367105|143231100|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.56|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.56
71858204|NCT02367105|143231101|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71858205|NCT02367105|143231102|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
71858206|NCT02367105|143231103|SUPERIORITY||Mean Difference (Final Values)|-42.0||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
71858207|NCT02367105|143231104|SUPERIORITY||Mean Difference (Final Values)|-29.0||||0.67|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.67
71858208|NCT02367105|143231105|SUPERIORITY||Mean Difference (Final Values)|-0.019||||0.003|TWO_SIDED||||||Mixed Models Analysis|Baseline valued adjusted||||||0.003
71858209|NCT02367105|143231106|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
71858210|NCT02367105|143231107|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.94|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.94
71858211|NCT02367105|143231108|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.41
71858212|NCT02367105|143231109|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.46|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.46
71858213|NCT02367105|143231110|SUPERIORITY|Baseline value adjusted|Mean Difference (Final Values)|0.6||||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
71858214|NCT02367105|143231111|SUPERIORITY||Mean Difference (Final Values)|-0.284||||0.003|TWO_SIDED||||||Mixed Models Analysis|||||||.003
71681240|NCT00772005|142881176|SUPERIORITY_OR_OTHER|||||||0.632||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6320
71858215|NCT02367105|143231112|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.16|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years of education as covariates||||||.16
71858216|NCT02367105|143231113|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.21|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.21
71858217|NCT02367105|143231114|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.41|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.41
71858218|NCT02367105|143231115|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value and years if education as covariates||||||.03
71858219|NCT02367105|143231116|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.03
71858220|NCT02367105|143231117|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.18|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||.18
71858221|NCT02367105|143231118|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.1|TWO_SIDED||||||Mixed Models Analysis|Baseline values and years of education as covariates||||||0.10
71858222|NCT02367105|143231119|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||.65
71858223|NCT02367105|143231120|SUPERIORITY||Mean Difference (Final Values)|0.553||||0.03|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.03
71858224|NCT02367105|143231121|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.04|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.04
71681241|NCT00772005|142881176|SUPERIORITY_OR_OTHER|||||||0.8777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8777
71681242|NCT00772005|142881176|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4378
71858225|NCT02367105|143231122|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.35|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.35
71858226|NCT02367105|143231123|SUPERIORITY||Median Difference (Final Values)|0.01||||0.65|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.65
71858227|NCT02367105|143231124|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.27|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.27
71858228|NCT02367105|143231125|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.39|TWO_SIDED|||||Baseline value adjusted|Mixed Models Analysis|||||||0.39
71858229|NCT02367105|143231126|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.58|TWO_SIDED||||||Mixed Models Analysis|||||||0.58
71858230|NCT02367105|143231127|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.9|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.90
71858231|NCT02367105|143231128|SUPERIORITY||Mean Difference (Final Values)|-252.0|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||<0.001
71858232|NCT02367105|143231129|SUPERIORITY||Mean Difference (Final Values)|-24.9|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline value as covariates||||||<0.001
71858233|NCT02367105|143231130|SUPERIORITY||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||<0.001
71858234|NCT02367105|143231131|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.31|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.31
71858235|NCT02367105|143231132|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.42|TWO_SIDED|||||Baseline values as covariates|Mixed Models Analysis|||||||0.42
71858236|NCT02367105|143231133|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.69
71858237|NCT02367105|143231134|SUPERIORITY||Mean Difference (Final Values)|-13.1||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline value adjusted||||||0.23
71858238|NCT02367105|143231135|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71858239|NCT02367105|143231136|SUPERIORITY||Mean Difference (Net)|-1.0||||0.36|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.36
71858240|NCT02367105|143231137|SUPERIORITY||Mean Difference (Final Values)|-8.6||||0.23|TWO_SIDED||||||Mixed Models Analysis|Baseline values as covariates||||||0.23
71858241|NCT02367105|143231138|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.69|TWO_SIDED||||||Mixed Models Analysis|Baseline values adjusted||||||0.69
71858242|NCT02367105|143231139|SUPERIORITY||Number of participants|0.0|||>|0.05|TWO_SIDED|||||A priori threshold = voxel p\<.001, cluster p\<.05, false discovery rate (FDR) whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design.|t-test, 2 sided|||||||>.05
71858243|NCT02367105|143231140|SUPERIORITY||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate.|t-test, 2 sided|||6 months vs Baseline||||0.37
71858244|NCT02367105|143231140|SUPERIORITY||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|0.12||0.02|TWO_SIDED|||||Using DESeq2 R package. P values were adjusted using the Benjamini and Hochberg's approach for controlling the false discovery rate|t-test, 2 sided|||6 months vs Baseline||||.02
71858245|NCT02367105|143231141|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.05|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||.05
71858246|NCT02367105|143231141|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|1.3||0.3|TWO_SIDED||||||Mixed Models Analysis|Final vs baseline||||||0.3
71858247|NCT01657877|143231144|NON_INFERIORITY_OR_EQUIVALENCE|The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be \<= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice.|Adjusted mean difference|-2.23||||0.2601|TWO_SIDED|95.0|-6.11|1.66|||ANOVA|Based on the mixed effects ANOVA considering treatment and study period as factors, and subject as random effect|Difference is 1500 ppm fluoride as SMFP and 0 % CSP minus 1500 ppm fluoride as SMFP and 5 % CSP such that a positive difference favors 1500 ppm fluoride as SMFP and 0 % CSP|The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.||1.66|-6.11|0.2601
71858248|NCT03398421|143231169|SUPERIORITY||Ratio of adjusted geometric mean|2.005|||||TWO_SIDED|90.0|1.807|2.224||||||||2.224|1.807|
71858249|NCT03398421|143231176|SUPERIORITY||Ratio of adjusted geometric mean|0.802|||||TWO_SIDED|90.0|0.69|0.933||||||||0.933|0.690|
71858250|NCT01313624|143231233|SUPERIORITY_OR_OTHER||Difference in least squares mean|0.8||||0.68|TWO_SIDED|95.0|-3.1|4.7||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||4.7|-3.1|0.68
71858251|NCT01313624|143231234|SUPERIORITY_OR_OTHER||Difference in least squares mean|1.3||||0.56|TWO_SIDED|95.0|-3.0|5.6||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM|||||5.6|-3.0|0.56
71858252|NCT03121612|143231264|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.65||||||Threshold for superiority p\<0.05; primary outcome, so not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.65
71858253|NCT03121612|143231264|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 28-33 gestational weeks (n=41). No adjustment for multiple comparisons.||||0.64
71858254|NCT03121612|143231264|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 34-36 gestational weeks (n=10). No adjustment for multiple comparisons.||||1.0
71858255|NCT03121612|143231265|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.8||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution not normal by visual examination, so non-parametric test (Wilcoxon) used."||||0.80
71858256|NCT03121612|143231266|SUPERIORITY|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.86||||||Threshold for superiority p\<0.05; not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."||||0.86
71858257|NCT03121612|143231270|SUPERIORITY|||||||1||||||Not adjusted for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
71858258|NCT03121612|143231271|SUPERIORITY|||||||0.33||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational group.||||||0.33
71858259|NCT03121612|143231272|SUPERIORITY|||||||0.31||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational age-group.||||||0.31
71681243|NCT00772005|142881177|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5544
71858260|NCT03121612|143231273|SUPERIORITY|||||||0.81||||||Not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||||||0.81
71681244|NCT00772005|142881177|SUPERIORITY_OR_OTHER|||||||0.4446||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4446
71858261|NCT03121612|143231274|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71858262|NCT03121612|143231280|SUPERIORITY|||||||1||||||No adjustment for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.||||||1.0
71858263|NCT03121612|143231282|SUPERIORITY|||||||1|||||||Fisher Exact|No adjustment for multiple comparisons||||||1.0
71858264|NCT01841112|143231289|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3712|||||TWO_SIDED|95.0|0.7272|2.0151|||||The standard error of slope estimate = 0.3038.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||2.0151|0.7272|
71858265|NCT01841112|143231289|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.3652|||||TWO_SIDED|95.0|1.0421|1.6883|||||The standard error of slope estimate = 0.1516.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.6883|1.0421|
71858266|NCT01841112|143231290|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.1998|||||TWO_SIDED|95.0|0.4794|1.9202|||||The standard error of slope estimate = 0.3380.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.9202|0.4794|
71858267|NCT01841112|143231290|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0299|||||TWO_SIDED|95.0|0.7131|1.3466|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3466|0.7131|
71858268|NCT01841112|143231291|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.2015|||||TWO_SIDED|95.0|0.5078|1.8952|||||The standard error of slope estimate = 0.3272.|Dose proportionality was assessed in Chinese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.8952|0.5078|
71858269|NCT01841112|143231291|SUPERIORITY_OR_OTHER_LEGACY||Slope|1.0301|||||TWO_SIDED|95.0|0.7133|1.3469|||||The standard error of slope estimate = 0.1486.|Dose proportionality was assessed in Japanese subjects. For the power model perfect dose proportionality would correspond to a slope of 1.||1.3469|0.7133|
71858270|NCT00878553|143231298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.606|STANDARD_ERROR_OF_MEAN|2.42||0.0118|TWO_SIDED|95.0|-15.284|-1.927||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-1.927|-15.284|0.0118
71858271|NCT00878553|143231298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.98|STANDARD_ERROR_OF_MEAN|2.421||0.0037|TWO_SIDED|95.0|-16.685|-3.275||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes||-3.275|-16.685|0.0037
71858272|NCT00878553|143231298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.153|STANDARD_ERROR_OF_MEAN|2.422||0.0077|TWO_SIDED|95.0|-15.857|-2.448||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo.|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05.|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 20-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||-2.448|-15.857|0.0077
71906505|NCT01511107|143335333|SUPERIORITY_OR_OTHER|||||||0.32|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.||||0.32
71681245|NCT00772005|142881177|SUPERIORITY_OR_OTHER|||||||0.4483||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4483
71681246|NCT00772005|142881178|SUPERIORITY_OR_OTHER|||||||0.1914||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1914
71681247|NCT00772005|142881178|SUPERIORITY_OR_OTHER|||||||0.2543||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2543
71681248|NCT00772005|142881178|SUPERIORITY_OR_OTHER|||||||0.9748||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9748
71681249|NCT00772005|142881179|SUPERIORITY_OR_OTHER|||||||0.5312||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5312
71681250|NCT00772005|142881179|SUPERIORITY_OR_OTHER|||||||0.7522||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7522
71858273|NCT00878553|143231299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.604|STANDARD_ERROR_OF_MEAN|2.755||0.1476|TWO_SIDED|95.0|-13.208|2.0||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.000|-13.208|0.1476
71858274|NCT00878553|143231299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.912|STANDARD_ERROR_OF_MEAN|2.757||0.0757|TWO_SIDED|95.0|-14.546|0.722||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||0.722|-14.546|0.0757
71858275|NCT00878553|143231299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.521|STANDARD_ERROR_OF_MEAN|2.757||0.1553|TWO_SIDED|95.0|-13.154|2.113||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.||2.113|-13.154|0.1553
71858276|NCT00878553|143231300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.831|STANDARD_ERROR_OF_MEAN|2.4||0.0092|TWO_SIDED|95.0|2.208|15.454||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||15.454|2.208|0.0092
71681251|NCT00772005|142881179|SUPERIORITY_OR_OTHER|||||||0.3183||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3183
71681252|NCT00772005|142881180|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
71681253|NCT00772005|142881180|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8910
71681254|NCT00772005|142881180|SUPERIORITY_OR_OTHER|||||||0.1795||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1795
71681255|NCT00772005|142881181|SUPERIORITY_OR_OTHER|||||||0.6378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6378
71858277|NCT00878553|143231300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.425|STANDARD_ERROR_OF_MEAN|2.402||0.0023|TWO_SIDED|95.0|3.775|17.075||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||17.075|3.775|0.0023
71858278|NCT00878553|143231300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.147|STANDARD_ERROR_OF_MEAN|2.402||0.003|TWO_SIDED|95.0|3.498|16.796||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.||16.796|3.498|0.0030
71858279|NCT00878553|143231301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.562|STANDARD_ERROR_OF_MEAN|0.244||0.1005|TWO_SIDED|95.0|-1.235|0.11||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||0.110|-1.235|0.1005
71858280|NCT00878553|143231301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.037|STANDARD_ERROR_OF_MEAN|0.244||0.0028|TWO_SIDED|95.0|-1.712|-0.362||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.362|-1.712|0.0028
71858281|NCT00878553|143231301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.793|STANDARD_ERROR_OF_MEAN|0.244||0.0216|TWO_SIDED|95.0|-1.467|-0.118||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustments for multiple testing were made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.||-0.118|-1.467|0.0216
71858282|NCT00878553|143231302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.452|STANDARD_ERROR_OF_MEAN|0.219||0.219|TWO_SIDED|95.0|-21.98|5.077||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||5.077|-21.980|0.2190
71858283|NCT00878553|143231302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.365|STANDARD_ERROR_OF_MEAN|4.937||0.8441|TWO_SIDED|95.0|-12.327|15.056||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A positive mean change from baseline indicates a worsening.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||15.056|-12.327|0.8441
71906506|NCT01511107|143335334|SUPERIORITY_OR_OTHER|||||||0.23|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.||||0.23
71906507|NCT01511107|143335335|SUPERIORITY_OR_OTHER|||||||0.22|||||||Regression, Poisson|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.||||0.22
71906508|NCT01511107|143335336|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Linear|The p-value is adjusted for site \& the stratification variables and for length of follow-up.||Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.||||<.001
71906509|NCT01511107|143335337|SUPERIORITY_OR_OTHER|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for site \& the stratification variables, episode, day of the diary and AOM-SOS score at the episode.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.||||0.07
71906510|NCT01511107|143335338|SUPERIORITY_OR_OTHER|||||||0.7|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.||||0.70
71906511|NCT01511107|143335339|SUPERIORITY_OR_OTHER|||||||0.86|||||||Regression, Logistic|The p-value is adjusted for site \& the stratification variables, namely age group \& exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.||||0.86
71858284|NCT00878553|143231302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.84|STANDARD_ERROR_OF_MEAN|4.936||0.0894|TWO_SIDED|95.0|-25.522|1.842||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.||1.842|-25.522|0.0894
71858285|NCT00878553|143231303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.469||0.6433|TWO_SIDED|95.0|-1.823|2.943||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||2.943|-1.823|0.6433
71858286|NCT00878553|143231303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.912|STANDARD_ERROR_OF_MEAN|1.523||0.1167|TWO_SIDED|95.0|-4.304|0.481||Analysis included effects for patient, period, sequence and treatment|Mixed Models Analysis||A negative mean difference from baseline indicates a worsening.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||0.481|-4.304|0.1167
71858287|NCT00878553|143231303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|1.626||0.2385|TWO_SIDED|95.0|-0.958|3.826||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.||3.826|-0.958|0.2385
71858288|NCT00878553|143231304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.256||0.0914|TWO_SIDED|95.0|-0.073|0.972|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.972|-0.073|0.0914
71858289|NCT00878553|143231304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.165|STANDARD_ERROR_OF_MEAN|0.259||0.536|TWO_SIDED|95.0|-0.36|0.69|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.690|-0.360|0.5360
71858290|NCT00878553|143231304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.262|STANDARD_ERROR_OF_MEAN|0.237||0.3254|TWO_SIDED|95.0|-0.787|0.263|||Mixed Models Analysis||A negative mean change from baseline indicates a worsening.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.||0.263|-0.787|0.3254
71858291|NCT00878553|143231305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.818||0.719|TWO_SIDED|95.0|-3.175|4.595||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates improvement.|||4.595|-3.175|0.7190
71858292|NCT00878553|143231305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.821|STANDARD_ERROR_OF_MEAN|2.422||0.6784|TWO_SIDED|95.0|-3.08|4.722||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||4.722|-3.080|0.6784
71858293|NCT00878553|143231305|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.314|STANDARD_ERROR_OF_MEAN|2.058||0.2433|TWO_SIDED|95.0|-1.586|6.214||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.|||6.214|-1.586|0.2433
71858294|NCT00878553|143231306|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.39||||0.0009|TWO_SIDED||||||ANOVA|F-test 2 degrees of freedom||Cmax(ng/mL) \[Maximum plasma zaleplon concentration\]||||0.0009
71858295|NCT00878553|143231307|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.9142||95.0|||||ANOVA|F-test two degrees of freedom||Cmax normalized per dose||||0.9142
71858296|NCT00878553|143231308|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.24||||0.1193||95.0|||||ANOVA|F-test 2 degrees of freedom||Time (hour)post-dose of maximum plasma zaleplon concentration||||0.1193
71858297|NCT00878553|143231309|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.85||||0.0003||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC ng\*h/mL)||||0.0003
71858298|NCT00878553|143231310|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.28||||0.2281||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC/Dose (ng\*h/mL/mg)||||0.2281
71858299|NCT00878553|143231311|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.4835||95.0|||||ANOVA|2 degrees of freedom F-test||Half-Life (t1/2 in hours) of plasma zaleplon from each of 3 doses of SKP-1041||||0.4835
71858300|NCT00461123|143231312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.5248||95.0|-4.18|8.05|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of least squares (LS) means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||8.05|-4.18|0.5248
71858301|NCT00461123|143231313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.87||95.0|-3.58|3.04|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||3.04|-3.58|0.8700
71858302|NCT00461123|143231314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.57||||0.4162||95.0|-8.21|19.35|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||19.35|-8.21|0.4162
71906512|NCT01283997|143335340|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.54|TWO_SIDED|95.0|-0.13|0.24|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the fingertip||0.24|-0.13|0.54
71858303|NCT00461123|143231315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5||||0.0588||95.0|-13.25|0.26|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90||0.26|-13.25|0.0588
71858304|NCT00461123|143231316|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.61||||0.7878||95.0|-22.03|16.82|||ANCOVA|Analysis of variance (ANOVA), treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group||16.82|-22.03|0.7878
71858305|NCT02250183|143231335|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|||||A priori threshold for statistical significance was p\<0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.|McNemar|McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.|2-sided|Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).||||1.00
71858306|NCT02250183|143231336|SUPERIORITY||Mean Difference (Final Values)|3.615|STANDARD_ERROR_OF_MEAN|0.79||0.003|TWO_SIDED|95.0|1.149|4.565||The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.|t-test, 2 sided|df = 13||A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p\<.05 level.||4.565|1.149|.003
71858307|NCT05896696|143231338|OTHER||Mean Difference (Final Values)|-1.87|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.26|||Paired sample t-test|||||-1.26|-2.49|<0.0001
71858308|NCT05896696|143231339|OTHER||Mean Difference (Final Values)|-1.22|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.73|||paired sample t-test|||||-0.73|-1.70|<0.0001
71858309|NCT02080403|143231344|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.1159|TWO_SIDED|95.0|-0.4|0.04|||Mixed Models Analysis|||||0.04|-0.40|0.1159
71858310|NCT01468077|143231380|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0164|||||TWO_SIDED|95.0|-0.2685|0.2988|||||The CI (confidence interval) is calculated by Exact method based on binomial distribution.|||0.2988|-0.2685|
71906513|NCT01283997|143335340|OTHER||Mean Difference (Final Values)|0.05||||0.6|TWO_SIDED|95.0|-0.13|0.23|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the palm||0.23|-0.13|0.60
71906514|NCT01283997|143335340|OTHER||Mean Difference (Final Values)|-0.12||||0.37|TWO_SIDED|95.0|-0.4|0.15|||Wilcoxon (Mann-Whitney)|||Difference in the measurements for touch by the forearm||0.15|-0.40|0.37
71906515|NCT01283997|143335341|OTHER||Mean Difference (Final Values)|-0.73||||0.56|TWO_SIDED|95.0|-2.06|0.59|||Wilcoxon (Mann-Whitney)|||Difference in Numbness severity at baseline and week 10.||0.59|-2.06|0.56
71906516|NCT03342937|143335358|SUPERIORITY|1-sided test of single exponential mean with historical null hypothesis of 5.5 months median PFS||||||0.02||||||Sample size of 35 patients was chosen based on detecting the difference between a historical median PFS of 5.5 months and experimental median of 7.3 months, a hazard ratio of 0.75, with 80% power (1-sided test of single exponential mean, α=0.2).|1-sided exponential test|||||||0.02
71906517|NCT01337167|143335369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|9.68|||<|0.001|TWO_SIDED|95.0|4.83|14.83|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=1.0 μg/mL||14.83|4.83|<0.001
71906518|NCT01337167|143335369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
71906519|NCT01337167|143335369|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419-Ctrl)|4.87|||<|0.001|TWO_SIDED|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Secondary Analysis: Non-inferiority for titer \>=0.15 μg/mL||8.14|2.23|<0.001
71906520|NCT01337167|143335370|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|0.84|||<|0.001|TWO_SIDED|95.0|-0.35|2.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.74|-0.35|<0.001
71906521|NCT01337167|143335371|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-3.84||||0.002|TWO_SIDED|95.0|-8.02|0.66|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||0.66|-8.02|0.002
71906522|NCT01337167|143335372|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.39|||<|0.001|TWO_SIDED|95.0|-0.28|1.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.74|-0.28|<0.001
71906523|NCT01337167|143335373|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.33|||<|0.001|TWO_SIDED|95.0|-1.8|1.6|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.60|-1.80|<0.001
71858311|NCT03024996|143231398|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.495|TWO_SIDED|95.0|0.75|1.15|||Log Rank|||||1.15|0.75|0.4950
71858312|NCT03024996|143231399|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8868||95.0|0.67|1.42|||Log Rank|||||1.42|0.67|0.8868
71858313|NCT03024996|143231400|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.201|TWO_SIDED|95.0|0.63|1.1|||Log Rank|||||1.10|0.63|0.2010
71681256|NCT00772005|142881181|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8679
71681257|NCT00772005|142881181|SUPERIORITY_OR_OTHER|||||||0.5489||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5489
71681258|NCT00772005|142881182|SUPERIORITY_OR_OTHER|||||||0.9337||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9337
71858314|NCT03024996|143231401|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.2811|TWO_SIDED|95.0|0.69|1.12|||Log Rank|||||1.12|0.69|0.2811
71858315|NCT03024996|143231402|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0735|TWO_SIDED|95.0|0.55|1.03|||Log Rank|||||1.03|0.55|0.0735
71858316|NCT03024996|143231403|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1396|TWO_SIDED|95.0|0.67|1.06|||Log Rank|||||1.06|0.67|0.1396
71858317|NCT03024996|143231404|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4762|TWO_SIDED|95.0|0.55|1.33|||Log Rank|||||1.33|0.55|0.4762
71858318|NCT03024996|143231405|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.5111|TWO_SIDED|95.0|0.74|1.16|||Log Rank|||||1.16|0.74|0.5111
71906524|NCT01337167|143335374|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-4.7||||0.001|TWO_SIDED|95.0|-8.14|-0.97|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||-0.97|-8.14|0.001
71858319|NCT02106195|143231425|SUPERIORITY|Change from Baseline to Day 28|Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|3.04||0.324|TWO_SIDED|95.0|-3.7|1.4|||t-test, 2 sided|||||1.4|-3.7|0.324
71858320|NCT04469465|143231431|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Interim Efficacy Analysis||||0.0007
71858321|NCT04469465|143231431|SUPERIORITY|||||||0.0007|||||||Re-randomization Test|||Full Analysis||||0.0007
71858322|NCT04469465|143231431|SUPERIORITY||LS Mean Difference|24.44|STANDARD_ERROR_OF_MEAN|3.751|<|0.0001|TWO_SIDED|95.0|16.9|31.99|||Mixed Models Analysis|||Interim Efficacy Analysis||31.99|16.90|<0.0001
71858323|NCT04469465|143231431|SUPERIORITY||Difference|23.46|STANDARD_ERROR_OF_MEAN|3.585|<|0.0001|TWO_SIDED|95.0|16.31|30.61|||Mixed Models Analysis|||Full Analysis||30.61|16.31|<0.0001
71858324|NCT01660256|143231450|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71858325|NCT01660256|143231451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71858326|NCT00551135|143231463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0668|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0668
71858327|NCT00551135|143231463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0334|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0334
71858328|NCT00551135|143231463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
71858329|NCT00551135|143231463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8003|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8003
71858330|NCT00551135|143231463|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6932|TWO_SIDED|||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6932
71858331|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4471|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4471
71858332|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7248|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7248
71858333|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7556|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7556
71858334|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0571|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0571
71858335|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0197|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0197
71681259|NCT00772005|142881182|SUPERIORITY_OR_OTHER|||||||0.9428||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9428
71858336|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2398|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2398
71858337|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0709|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0709
71858338|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9902|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9902
71858339|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0018
71858340|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4639|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4639
71858341|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4845|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4845
71858342|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1641|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1641
71858343|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1025|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1025
71858344|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5615|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5615
71858345|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2904|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2904
71858346|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6017|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6017
71858347|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8549|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8549
71858348|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3386|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3386
71858349|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
71858350|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5244|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5244
71858351|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4245|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4245
71858352|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8624
71858353|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7552|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7552
71858354|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7329|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7329
71858355|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3053|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3053
71858356|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.529|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5290
71858357|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7951|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7951
71858358|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7150
71858359|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4566|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4566
71858360|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.775|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7750
71858361|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9241|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9241
71858362|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8994|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8994
71858363|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2088|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2088
71858364|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2152|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2152
71921977|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.2|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-7.7|3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||3.4|-7.7|
71858365|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7662|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7662
71858366|NCT00551135|143231464|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7579|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7579
71858367|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6896|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6896
71858368|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1934|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1934
71858369|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6034|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6034
71858370|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7992|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7992
71858371|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4770
71858372|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
71858373|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2000
71858374|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5059|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5059
71858375|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
71858376|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3815|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3815
71858377|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4716|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4716
71858378|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1063|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1063
71858379|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3884|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3884
71858380|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3787|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3787
71858381|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2537|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2537
71858382|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0952|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0952
71858383|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7725|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7725
71858384|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.066|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0660
71858385|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3657|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3657
71858386|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7717|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7717
71858387|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5849|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5849
71858388|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.958|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9580
71858389|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9884|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9884
71858390|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6743|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6743
71858391|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2689|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2689
71858392|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6907|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6907
71858393|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4798|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4798
71858394|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5609|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5609
71858395|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9834|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9834
71858396|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8339|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8339
71858397|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8730
71858398|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6327|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6327
71858399|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3986|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3986
71858400|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.637|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6370
71681260|NCT00772005|142881182|SUPERIORITY_OR_OTHER|||||||0.5895||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5895
71858401|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9869
71858402|NCT00551135|143231465|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7550
71858403|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2912
71858404|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3723|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3723
71858405|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6116|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6116
71858406|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0835|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0835
71858407|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1497|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1497
71858408|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.395|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3950
71858409|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5892|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5892
71858410|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6143|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6143
71858411|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0104
71858412|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5666|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5666
71858413|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9008|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9008
71858414|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0967|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0967
71858415|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8353|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8353
71858416|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.453|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4530
71858417|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7297|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7297
71906525|NCT01337167|143335375|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-2.67|||<|0.001|TWO_SIDED|95.0|-7.27|2.23|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||2.23|-7.27|<0.001
71906526|NCT01337167|143335376|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|4.05|||<|0.001|TWO_SIDED|95.0|0.23|8.28|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||8.28|0.23|<0.001
71858418|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0692
71858419|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6333|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6333
71858420|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0325|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0325
71858421|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5788|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5788
71858422|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9224|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9224
71858423|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5527|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5527
71858424|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2624|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2624
71858425|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3263|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3263
71858426|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3746|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3746
71858427|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0050
71858428|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0493|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0493
71858429|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0773|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0773
71858430|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0547|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0547
71858431|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1976
71858432|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3832|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3832
71858433|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4216|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4216
71858434|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5852|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5852
71858435|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7336|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7336
71858436|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1647|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1647
71858437|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2813|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2813
71858438|NCT00551135|143231466|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8423|TWO_SIDED||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8423
71858439|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.397|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.3970
71858440|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.764|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7640
71858441|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5064|TWO_SIDED||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5064
71858442|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1318|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1318
71858443|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9367
71858444|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1259|TWO_SIDED||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1259
71858445|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1812|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1812
71858446|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9600
71858447|NCT00551135|143231467|SUPERIORITY_OR_OTHER_LEGACY|||||||0.105|TWO_SIDED||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.1050
71858448|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2818|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2818
71858449|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8631|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8631
71858450|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5074
71858451|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0401|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0401
71858452|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5509|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5509
71858453|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0004
71858454|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7070
71858455|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.384|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3840
71858456|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2732|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2732
71858457|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4418|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4418
71858458|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8379
71681261|NCT00772005|142881183|SUPERIORITY_OR_OTHER|||||||0.8695||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8695
71858459|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5944|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5944
71858460|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8139|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8139
71858461|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9709|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9709
71858462|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9666|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9666
71858463|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3204|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3204
71858464|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0869|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0869
71858465|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9386|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9386
71858466|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4352|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4352
71858467|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4522|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4522
71858468|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6606|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6606
71858469|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1733|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1733
71858470|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8788|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8788
71858471|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8474|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8474
71858472|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2938|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2938
71858473|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7602|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7602
71858474|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6881|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6881
71858475|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7883|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7883
71858476|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5374|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5374
71858477|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9774|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9774
71858478|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3082|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3082
71858479|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4373|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4373
71858480|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.654|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6540
71858481|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0002
71858482|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0696
71858483|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0029|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0029
71858484|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3695|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3695
71858485|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9346|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9346
71858486|NCT00551135|143231468|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9631|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9631
71858487|NCT00551135|143231469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9025|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.9025
71858488|NCT00551135|143231469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5652|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.5652
71858489|NCT00551135|143231469|SUPERIORITY_OR_OTHER_LEGACY|||||||0.792|TWO_SIDED||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."||||0.7920
71858490|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6679|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6679
71858491|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7308|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7308
71858492|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6781|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6781
71858493|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.093|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0930
71858494|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3751|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3751
71858495|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0111|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0111
71858496|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6811|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6811
71858497|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7426|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7426
71858498|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1619|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1619
71858499|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1132|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1132
71858500|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9822|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9822
71858501|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1883|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1883
71858502|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9391|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9391
71858503|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9664|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9664
71858504|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0747|TWO_SIDED||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0747
71858505|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9681|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9681
71858506|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3246|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3246
71858507|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7984|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7984
71858508|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8581|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8581
71858509|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9677|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9677
71858510|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7104|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7104
71858511|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8978|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8978
71858512|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.626|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6260
71858513|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4047|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4047
71858514|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4461
71858515|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9099|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9099
71858516|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8805|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8805
71858517|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2348|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2348
71858518|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4445|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4445
71858519|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8849|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8849
71858520|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2796|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2796
71858521|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5225|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5225
71858522|NCT00551135|143231470|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7015|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7015
71858523|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3332|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3332
71858524|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0933|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0933
71858525|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0031
71858526|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9451|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9451
71858527|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7312|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7312
71858528|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0348|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0348
71858529|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8936|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8936
71858530|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7672|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7672
71681262|NCT00772005|142881183|SUPERIORITY_OR_OTHER|||||||0.6637||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6637
71858531|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4285|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4285
71858532|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0785|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0785
71858533|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3348|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3348
71858534|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1366|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1366
71858535|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3338|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3338
71858536|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4460
71858537|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1078|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1078
71858538|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8273|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8273
71858539|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6140
71858540|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1684|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1684
71858541|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
71858542|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2640
71858543|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8956|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8956
71858544|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0058|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0058
71858545|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9929|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9929
71858546|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0473|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0473
71858547|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2426|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2426
71858548|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3478|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3478
71858549|NCT00551135|143231474|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1694|TWO_SIDED||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1694
71858550|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0630
71858551|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
71858552|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024|TWO_SIDED||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0024
71858553|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0767|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0767
71858554|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1327|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1327
71858555|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0078
71858556|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0694|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0694
71858557|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2173|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2173
71858558|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193|TWO_SIDED||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0193
71858559|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0673|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0673
71858560|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2629|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2629
71858561|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0388|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0388
71858562|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0651|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0651
71858563|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3242|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3242
71858564|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0345|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0345
71858565|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0487|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0487
71858566|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3384
71858567|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0467|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0467
71858568|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0347|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0347
71858569|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3086|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3086
71858570|NCT00551135|143231475|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0406|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0406
71858571|NCT00551135|143231476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4177|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4177
71858572|NCT00551135|143231476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.441|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4410
71858573|NCT00551135|143231476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.556|TWO_SIDED||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5560
71858574|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
71858575|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
71858576|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
71858577|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5272|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5272
71858578|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4257|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4257
71858579|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1428|TWO_SIDED||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1428
71858580|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2316|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2316
71858581|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3468|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3468
71906527|NCT01337167|143335377|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|1.76|||<|0.001|TWO_SIDED|95.0|0.85|3.59|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.59|0.85|<0.001
71681263|NCT00772005|142881183|SUPERIORITY_OR_OTHER|||||||0.3152||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3152
71858582|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5367|TWO_SIDED||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5367
71858583|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0549|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0549
71858584|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1351|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1351
71681264|NCT00772005|142881184|SUPERIORITY_OR_OTHER|||||||0.7472||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7472
71858585|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9599|TWO_SIDED||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9599
71858586|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4273|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4273
71858587|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4466|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4466
71858588|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3785|TWO_SIDED||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3785
71858589|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2869|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2869
71858590|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9905|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9905
71858591|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9381|TWO_SIDED||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9381
71858592|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2158|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2158
71858593|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7887|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7887
71858594|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.925|TWO_SIDED||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9250
71681265|NCT00772005|142881184|SUPERIORITY_OR_OTHER|||||||0.4503||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4503
71858595|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1472|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1472
71858596|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5383|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5383
71858597|NCT00551135|143231477|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8869|TWO_SIDED||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8869
71858598|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.4024
71858599|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9766|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9766
71858600|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9975|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;||||0.9975
71858601|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9038|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9038
71858602|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.9370
71858603|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2134|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;||||0.2134
71858604|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2482
71858605|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.2207
71858606|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;||||0.9191
71858607|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0686
71858608|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0746
71858609|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0512|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;||||0.0512
71858610|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7118|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.7118
71858611|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9883|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9883
71858612|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.977|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;||||0.9770
71858613|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5457|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.5457
71858614|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2579|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.2579
71858615|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;||||0.1232
71858616|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.288|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.2880
71858617|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0894|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.0894
71858618|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1979|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;||||0.1979
71858619|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0686|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0686
71858620|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0746|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.0746
71858621|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4669|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;||||0.4669
71858622|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.5533
71858623|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
71858624|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1611|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;||||0.1611
71858625|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.4793
71858626|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3533|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.3533
71858627|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8852|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;||||0.8852
71858628|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
71858629|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.3173
71681266|NCT00772005|142881184|SUPERIORITY_OR_OTHER|||||||0.3127||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3127
71858630|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8864|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;||||0.8864
71858631|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8084|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.8084
71858632|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.3173
71858633|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;||||0.2207
71858634|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.3747
71858635|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.1450
71858636|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2054|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;||||0.2054
71858637|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4106|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.4106
71858638|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2199
71858639|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2896|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;||||0.2896
71858640|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||1.0000
71858641|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3173
71858642|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;||||0.3943
71858643|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1703|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.1703
71858644|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0807|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.0807
71858645|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7728|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;||||0.7728
71858646|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.4770
71858647|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3625|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.3625
71858648|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0617|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;||||0.0617
71858649|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3061|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 72 h PS;||||0.3061
71858650|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.2207
71858651|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;||||0.3173
71858652|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.9191
71858653|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.3173
71858654|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;||||0.2207
71858655|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6692|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6692
71858656|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7793|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.7793
71858657|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6065|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;||||0.6065
71858658|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.357|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.3570
71858659|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.9690
71858660|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5299|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;||||0.5299
71858661|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4821|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.4821
71858662|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8295|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.8295
71906528|NCT01337167|143335377|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
71906529|NCT01337167|143335378|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.26|||<|0.001|TWO_SIDED|95.0|-0.22|1.42|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.42|-0.22|<0.001
71906530|NCT01337167|143335378|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.54|<0.001
71906531|NCT01337167|143335379|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -5%|Response Rate Difference (V419 - Ctrl)|0.25|||<|0.001|TWO_SIDED|95.0|-0.24|1.41|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||1.41|-0.24|<0.001
71681267|NCT00772005|142881185|SUPERIORITY_OR_OTHER|||||||0.9193||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9193
71858663|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3304|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;||||0.3304
71858664|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 3 h PS;||||0.2482
71858665|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2482
71858666|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.2207
71858667|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8055|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;||||0.8055
71858668|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9191|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.9191
71858669|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8488|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.8488
71858670|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;||||0.2482
71858671|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
71858672|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2207|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2207
71858673|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;||||0.2482
71858674|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3291|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.3291
71858675|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1391|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.1391
71858676|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6318|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;||||0.6318
71858677|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6319|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.6319
71858678|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8149|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.8149
71858679|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5795|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;||||0.5795
71858680|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.1750
71858681|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0676|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;||||0.0676
71858682|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2943|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.2943
71858683|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0719|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;||||0.0719
71858684|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9283|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9283
71906532|NCT01337167|143335379|SUPERIORITY_OR_OTHER||Response Rate|100.0|||<|0.001|TWO_SIDED|95.0|99.53|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \>=90||||100.00|99.53|<0.001
71906533|NCT01337167|143335380|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.2|1.38|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.38|1.20|<0.001
71858685|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9024|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.9024
71858686|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7655|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;||||0.7655
71906534|NCT01337167|143335381|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.64||||0.786|TWO_SIDED|95.0|0.59|0.7|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.70|0.59|0.786
71906535|NCT01337167|143335382|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.83|||<|0.001|TWO_SIDED|95.0|0.73|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.95|0.73|<0.001
71906536|NCT01337167|143335383|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|TWO_SIDED|95.0|1.15|1.42|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.42|1.15|<0.001
71906537|NCT01337167|143335384|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.88|||<|0.001|TWO_SIDED|95.0|0.39|4.18|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.18|0.39|<0.001
71906538|NCT01337167|143335385|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|1.3|||<|0.001|TWO_SIDED|95.0|-1.67|4.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||4.78|-1.67|<0.001
71906539|NCT01337167|143335386|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|-0.41|||<|0.001|TWO_SIDED|95.0|-3.46|3.1|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||3.10|-3.46|<0.001
71906540|NCT01337167|143335387|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \>= -10%|Response Rate Difference (V419 - Ctrl)|6.18|||<|0.001|TWO_SIDED|95.0|3.26|9.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||||9.78|3.26|<0.001
71906541|NCT01337167|143335388|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.4|||<|0.001|TWO_SIDED|95.0|1.28|1.52|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.52|1.28|<0.001
71858687|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||1.0000
71906542|NCT01337167|143335389|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.0|||<|0.001|TWO_SIDED|95.0|0.91|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.10|0.91|<0.001
71906543|NCT01337167|143335390|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|0.78||||0.014|TWO_SIDED|95.0|0.68|0.89|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||0.89|0.68|0.014
71906544|NCT01337167|143335391|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.58|||<|0.001|TWO_SIDED|95.0|1.41|1.78|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.78|1.41|<0.001
71906545|NCT01337167|143335392|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.62|||<|0.001|TWO_SIDED|95.0|1.32|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.98|1.32|<0.001
71906546|NCT01337167|143335393|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \>=0.67|GMC Ratio (V419/Control)|1.02|||<|0.001|TWO_SIDED|95.0|0.83|1.24|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||||1.24|0.83|<0.001
71906547|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||||TWO_SIDED|95.0|-18.4|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \<38°C||-7.7|-18.4|
71906548|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||||TWO_SIDED|95.0|0.5|9.5|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38°C and \<38.5°C||9.5|0.5|
71906549|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|2.8|11.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=38.5°C and \<39.5°C||11.2|2.8|
71906550|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|||||TWO_SIDED|95.0|-0.6|2.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes \>=39.5°C||2.2|-0.6|
71681268|NCT00772005|142881185|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4814
71858688|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.846|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.8460
71858689|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6419|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;||||0.6419
71858690|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9522|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.9522
71858691|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.5800
71858692|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7675|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;||||0.7675
71858693|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1672|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1672
71858694|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9634|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.9634
71858695|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1161|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;||||0.1161
71858696|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0754|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0754
71858697|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
71858698|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0711|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;||||0.0711
71858699|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
71681269|NCT00772005|142881185|SUPERIORITY_OR_OTHER|||||||0.6097||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6097
71858700|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8091|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.8091
71858701|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2482|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;||||0.2482
71858702|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
71858703|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.3173
71858704|NCT00551135|143231478|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4386|TWO_SIDED|||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;||||0.4386
71858705|NCT00551135|143231479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1723
71858706|NCT00551135|143231479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0639|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS||||0.0639
71858707|NCT00551135|143231479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.0021
71681270|NCT00772005|142881186|SUPERIORITY_OR_OTHER|||||||0.8594||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8594
71858708|NCT00551135|143231479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1127|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.1127
71858709|NCT00551135|143231479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0703|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0703
71906551|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.2|||||TWO_SIDED|95.0|-18.6|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \<38°C||-7.7|-18.6|
71681271|NCT00772005|142881186|SUPERIORITY_OR_OTHER|||||||0.6157||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6157
71858710|NCT00551135|143231479|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|TWO_SIDED|||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.||||0.0012
71858711|NCT00551135|143231481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1927|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.||||0.1927
71858712|NCT00551135|143231481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3865|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS||||0.3865
71858713|NCT00551135|143231481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9869|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.9869
71858714|NCT00551135|143231481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4354|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.4354
71858715|NCT00551135|143231481|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.||||0.8061
71858716|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1682|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1682
71858717|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2821|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2821
71858718|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4781|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4781
71858719|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0557|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0557
71858720|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6098|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6098
71858721|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1821|TWO_SIDED||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1821
71858722|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1628|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1628
71858723|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8999
71858724|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
71858725|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2665|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2665
71858726|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4885|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4885
71858727|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6415|TWO_SIDED||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6415
71906552|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.5|||||TWO_SIDED|95.0|1.9|10.8|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38°C and \<38.5°C||10.8|1.9|
71906553|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||||TWO_SIDED|95.0|2.4|10.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=38.5°C and \<39.5°C||10.7|2.4|
71858728|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2269|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2269
71858729|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3228|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3228
71858730|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1808|TWO_SIDED||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1808
71858731|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3282|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3282
71858732|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0342|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0342
71858733|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4198|TWO_SIDED||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4198
71858734|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9049|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9049
71858735|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0456
71858736|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2463|TWO_SIDED||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2463
71858737|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8231|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8231
71858738|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0221|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0221
71858739|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6974|TWO_SIDED||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6974
71681272|NCT00772005|142881186|SUPERIORITY_OR_OTHER|||||||0.4846||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4846
71858740|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7461|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7461
71858741|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1198|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1198
71858742|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8031|TWO_SIDED||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8031
71858743|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8515|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8515
71858744|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1285|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1285
71858745|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5561|TWO_SIDED||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5561
71858746|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6858|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6858
71858747|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0693|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0693
71858748|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5547|TWO_SIDED||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5547
71858749|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.461|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4610
71858750|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.664|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6640
71858751|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6158|TWO_SIDED||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6158
71858752|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1632|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1632
71858753|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1770
71858754|NCT00551135|143231482|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4882|TWO_SIDED||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4882
71858755|NCT00551135|143231483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7936|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7936
71858756|NCT00551135|143231483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5092|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5092
71858757|NCT00551135|143231483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4233|TWO_SIDED||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4233
71858758|NCT00551135|143231483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2033|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2033
71858759|NCT00551135|143231483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2142|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2142
71858760|NCT00551135|143231483|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1218|TWO_SIDED||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1218
71858761|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.083|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0830
71858762|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2339|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2339
71858763|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0629|TWO_SIDED||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0629
71858764|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5721|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5721
71858765|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9713|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9713
71858766|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4809|TWO_SIDED||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4809
71858767|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1561|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1561
71858768|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5267|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5267
71858769|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1125|TWO_SIDED||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1125
71858770|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2965|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2965
71858771|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7774|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.7774
71858772|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399|TWO_SIDED||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3990
71858773|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4465|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4465
71858774|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4385|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.4385
71858775|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2265|TWO_SIDED||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2265
71858776|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5985|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.5985
71858777|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2146|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.2146
71681273|NCT00772005|142881187|SUPERIORITY_OR_OTHER|||||||0.6076||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6076
71681274|NCT00772005|142881187|SUPERIORITY_OR_OTHER|||||||0.5827||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5827
71858778|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3382|TWO_SIDED||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.3382
71858779|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.043|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0430
71858780|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1128|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.1128
71858781|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0632|TWO_SIDED||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.0632
71858782|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8667|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.8667
71858783|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6365|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.6365
71858784|NCT00551135|143231484|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9275|TWO_SIDED||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.||||0.9275
71858785|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2136
71858786|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0094|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0094
71858787|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2131|TWO_SIDED||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2131
71858788|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3245|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3245
71858789|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.407|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.4070
71858790|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.349|TWO_SIDED||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.3490
71858791|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1122|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1122
71858792|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.138|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.1380
71858793|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2023|TWO_SIDED||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2023
71858794|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2639|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2639
71858795|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2524|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.2524
71858796|NCT00551135|143231486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0832|TWO_SIDED||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.||||0.0832
71858797|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2371|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.2371
71858798|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4435|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.4435
71858799|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1692|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.||||0.1692
71858800|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8169|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.8169
71858801|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.5592
71858802|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4453|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.||||0.4453
71858803|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4795|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.4795
71858804|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2733|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.2733
71858805|NCT00551135|143231487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED|||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.||||0.3173
71858806|NCT00858247|143231492|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
71858807|NCT00858247|143231493|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||||||0.80
71858808|NCT00858247|143231494|SUPERIORITY_OR_OTHER|||||||0.65|||||||ANCOVA|||||||0.65
71858809|NCT00858247|143231495|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||||||0.68
71858810|NCT00858247|143231496|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANCOVA|||||||0.40
71858811|NCT00858247|143231497|SUPERIORITY_OR_OTHER|||||||0.47|||||||ANCOVA|||||||0.47
71858812|NCT00553605|143231498|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.|Least-squares (LS) mean difference|-1.12|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.53|4.3||||||LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.||4.30|-6.53|
71858813|NCT00553605|143231499|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|2.52||0.972|TWO_SIDED|95.0|-5.04|4.86|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||4.86|-5.04|0.972
71858814|NCT00553605|143231501|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|2.56||0.768|TWO_SIDED|95.0|-4.28|5.79|||ANCOVA|||Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.79|-4.28|0.768
71858815|NCT00553605|143231501|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|2.91||0.866|TWO_SIDED|95.0|-6.22|5.24|||ANCOVA|||Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||5.24|-6.22|0.866
71858816|NCT00553605|143231501|SUPERIORITY_OR_OTHER||LS mean difference|0.94|STANDARD_ERROR_OF_MEAN|2.7||0.729|TWO_SIDED|95.0|-4.38|6.26|||ANCOVA|||Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.26|-4.38|0.729
71858817|NCT00553605|143231501|SUPERIORITY_OR_OTHER||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|2.47||0.29|TWO_SIDED|95.0|-2.24|7.48|||ANCOVA|||Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||7.48|-2.24|0.290
71858818|NCT00553605|143231501|SUPERIORITY_OR_OTHER||LS mean difference|2.16|STANDARD_ERROR_OF_MEAN|2.14||0.314|TWO_SIDED|95.0|-2.05|6.37|||ANCOVA|||Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||6.37|-2.05|0.314
71858819|NCT00553605|143231501|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|1.72||0.926|TWO_SIDED|95.0|-3.23|3.55|||ANCOVA|||Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.||3.55|-3.23|0.926
71858820|NCT00553605|143231502|SUPERIORITY_OR_OTHER||LS mean difference|10.13|STANDARD_ERROR_OF_MEAN|13.43||0.451|TWO_SIDED|95.0|-16.3|36.54|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.||36.54|-16.3|0.451
71858821|NCT00553605|143231503|SUPERIORITY_OR_OTHER|||||||0.3982|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.3982
71858822|NCT00553605|143231503|SUPERIORITY_OR_OTHER|||||||0.5552|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.5552
71858823|NCT00553605|143231504|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.007||||0.9785|TWO_SIDED|95.0|0.6|1.69|||Regression, Logistic|||p-value was based on logistic regression model with terms for treatment group and baseline as covariates.||1.69|0.60|0.9785
71858824|NCT00553605|143231505|SUPERIORITY_OR_OTHER|||||||0.2482|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.2482
71858825|NCT00553605|143231505|SUPERIORITY_OR_OTHER|||||||0.7659|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.7659
71858826|NCT00553605|143231506|SUPERIORITY_OR_OTHER|||||||0.9783|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.9783
71858827|NCT00553605|143231506|SUPERIORITY_OR_OTHER|||||||0.6847|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.||||0.6847
71858828|NCT00553605|143231507|SUPERIORITY_OR_OTHER|||||||0.9645|TWO_SIDED||||||Log Rank|||||||0.9645
71858829|NCT02669407|143231514|OTHER|Single group|||||<|0.001|||||||Tukey's method|||||||<0.001
71858830|NCT02669407|143231515|OTHER|Single group||||||0.001|||||||Tukey's method|||Baseline, 30 minutes||||0.001
71858831|NCT02669407|143231516|OTHER|Single group||||||0.007|||||||Tukey's method|||baseline, 30 minutes||||0.007
71858832|NCT02669407|143231520|OTHER|Single group||||||0.237|||||||t-test, 2 sided|||Change in left ventricular end diastolic dimension||||0.237
71858833|NCT02669407|143231520|OTHER|Single group||||||0.586|||||||t-test, 2 sided|||Change in left ventricular end systolic dimension||||0.586
71858834|NCT02669407|143231521|OTHER|Single group||||||0.175|||||||t-test, 2 sided|||||||0.175
71858835|NCT02669407|143231523|OTHER|Single group||||||0.061|||||||t-test, 2 sided|||||||0.061
71858836|NCT02669407|143231524|OTHER|Single group||||||0.787|||||||t-test, 2 sided|||||||0.787
71858837|NCT02669407|143231526|OTHER|Single group||||||0.606|||||||t-test, 2 sided|||Baseline, 90 minutes||||0.606
71858838|NCT02669407|143231526|OTHER|Single group||||||0.045|||||||t-test, 2 sided|||Baseline, 24 hours||||0.045
71858839|NCT01163955|143231675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|1.92|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in the floor.||9|0|<.0005
71858840|NCT01163955|143231675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|1.99|<|0.0005|TWO_SIDED|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in a chair.||9|0|<.0005
71858841|NCT02586415|143231676|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.63|4.7||Criteria to assess superiority was a two-sided P value of \<0.05. The study was terminated early because the pre-specified stopping boundary of P \<0.0025 was crossed at the first interim analysis (N=182)|Cochran-Mantel-Haenszel|||||4.70|1.63|<0.001
71681275|NCT00772005|142881187|SUPERIORITY_OR_OTHER|||||||0.7865||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7865
71681276|NCT00772005|142881188|SUPERIORITY_OR_OTHER|||||||0.3045||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3045
71858842|NCT00846768|143231745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3011||95.0|-0.014|0.044|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.044|-0.014|0.3011
71858843|NCT00846768|143231745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.015||0.1582||95.0|-0.008|0.05|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.050|-0.008|0.1582
71858844|NCT00846768|143231745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.015||0.0003||95.0|0.025|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.083|0.025|0.0003
71858845|NCT00846768|143231745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.7046||95.0|-0.034|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.023|-0.034|0.7046
71858846|NCT00846768|143231745|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.015||0.0248||95.0|0.004|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.063|0.004|0.0248
71858847|NCT00846768|143231746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.052|STANDARD_ERROR_OF_MEAN|0.015||0.0006||95.0|-0.081|-0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.023|-0.081|0.0006
71858848|NCT00846768|143231746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.047|STANDARD_ERROR_OF_MEAN|0.015||0.0019||95.0|-0.076|-0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.017|-0.076|0.0019
71858849|NCT00846768|143231746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012|STANDARD_ERROR_OF_MEAN|0.015||0.4111||95.0|-0.041|0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.017|-0.041|0.4111
71858850|NCT00846768|143231746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.015||0.709||95.0|-0.035|0.024|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.024|-0.035|0.7090
71858851|NCT00846768|143231746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.015||0.0211||95.0|0.005|0.064|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.064|0.005|0.0211
71858852|NCT00846768|143231747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.014||0.1753||95.0|-0.045|0.008|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.008|-0.045|0.1753
71858853|NCT00846768|143231747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.013|STANDARD_ERROR_OF_MEAN|0.014||0.3444||95.0|-0.04|0.014|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.014|-0.040|0.3444
71858854|NCT00846768|143231747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.014||0.1161||95.0|-0.005|0.049|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.049|-0.005|0.1161
71858855|NCT00846768|143231747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.014||0.6789||95.0|-0.033|0.021|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.021|-0.033|0.6789
71858856|NCT00846768|143231747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.014||0.0129||95.0|0.007|0.062|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.062|0.007|0.0129
71858857|NCT00846768|143231748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.017||0.4931||95.0|-0.023|0.047|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.047|-0.023|0.4931
71858858|NCT00846768|143231748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.2597||95.0|-0.015|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.054|-0.015|0.2597
71858859|NCT00846768|143231748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.018||0.0006||95.0|0.027|0.097|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.097|0.027|0.0006
71858860|NCT00846768|143231748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6578||95.0|-0.042|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.027|-0.042|0.6578
71858861|NCT00846768|143231748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.018||0.0175||95.0|0.008|0.077|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.077|0.008|0.0175
71858862|NCT00846768|143231749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.042|STANDARD_ERROR_OF_MEAN|0.02||0.0353||95.0|-0.081|-0.003|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.003|-0.081|0.0353
71858863|NCT00846768|143231749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2875||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.018|-0.060|0.2875
71858864|NCT00846768|143231749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.015|STANDARD_ERROR_OF_MEAN|0.02||0.4553||95.0|-0.024|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.054|-0.024|0.4553
71858865|NCT00846768|143231749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.021|STANDARD_ERROR_OF_MEAN|0.02||0.2902||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.018|-0.060|0.2902
71858866|NCT00846768|143231749|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.036|STANDARD_ERROR_OF_MEAN|0.02||0.0731||95.0|-0.003|0.075|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.075|-0.003|0.0731
71858867|NCT00846768|143231750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.027||0.0917||95.0|-0.008|0.099|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.099|-0.008|0.0917
71858868|NCT00846768|143231750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041|STANDARD_ERROR_OF_MEAN|0.027||0.1273||95.0|-0.012|0.095|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.095|-0.012|0.1273
71858869|NCT00846768|143231750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.027||0.008||95.0|0.019|0.127|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.127|0.019|0.0080
71858870|NCT00846768|143231750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8683||95.0|-0.049|0.058|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.058|-0.049|0.8683
71858871|NCT00846768|143231750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.027||0.2444||95.0|-0.022|0.086|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.086|-0.022|0.2444
71858872|NCT00846768|143231751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.099|STANDARD_ERROR_OF_MEAN|0.032||0.0023||95.0|-0.162|-0.036|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||-0.036|-0.162|0.0023
71858873|NCT00846768|143231751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.103|STANDARD_ERROR_OF_MEAN|0.032||0.0015||95.0|-0.165|-0.04|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||-0.040|-0.165|0.0015
71858874|NCT00846768|143231751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.024|STANDARD_ERROR_OF_MEAN|0.032||0.4508||95.0|-0.087|0.039|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.039|-0.087|0.4508
71858875|NCT00846768|143231751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.032||0.9087||95.0|-0.059|0.066|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.066|-0.059|0.9087
71858876|NCT00846768|143231751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.032||0.0146||95.0|0.016|0.142|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.142|0.016|0.0146
71858877|NCT00846768|143231752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.027|STANDARD_ERROR_OF_MEAN|0.027||0.3291||95.0|-0.08|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.027|-0.080|0.3291
71858878|NCT00846768|143231752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.027||0.2638||95.0|-0.084|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.023|-0.084|0.2638
71858879|NCT00846768|143231752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.027||0.3386||95.0|-0.028|0.08|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.080|-0.028|0.3386
71858880|NCT00846768|143231752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.027||0.8877||95.0|-0.05|0.057|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.057|-0.050|0.8877
71858881|NCT00846768|143231752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0402||95.0|0.003|0.111|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.111|0.003|0.0402
71681277|NCT00772005|142881188|SUPERIORITY_OR_OTHER|||||||0.0617||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0617
71681278|NCT00772005|142881188|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0580
71858882|NCT00846768|143231753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.084|STANDARD_ERROR_OF_MEAN|0.034||0.0133||95.0|0.018|0.151|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.151|0.018|0.0133
71858883|NCT00846768|143231753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.034||0.045||95.0|0.002|0.135|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.135|0.002|0.0450
71858884|NCT00846768|143231753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.092|STANDARD_ERROR_OF_MEAN|0.034||0.0078||95.0|0.025|0.159|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.159|0.025|0.0078
71858885|NCT00846768|143231753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.034||0.6268||95.0|-0.05|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.083|-0.050|0.6268
71858886|NCT00846768|143231753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.034||0.4891||95.0|-0.044|0.091|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.091|-0.044|0.4891
71858887|NCT00846768|143231754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6259||95.0|-0.097|0.059|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid|||0.059|-0.097|0.6259
71858888|NCT00846768|143231754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.039||0.919||95.0|-0.082|0.074|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid|||0.074|-0.082|0.9190
71858889|NCT00846768|143231754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.04||0.0985||95.0|-0.012|0.145|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid|||0.145|-0.012|0.0985
71858890|NCT00846768|143231754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.039||0.6991||95.0|-0.093|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd|||0.063|-0.093|0.6991
71858891|NCT00846768|143231754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.04||0.0802||95.0|-0.009|0.149|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid|||0.149|-0.009|0.0802
71858892|NCT00909532|143231801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.6|12.6||The primary and key secondary endpoints were analyzed using Hochberg's step-up procedure: test 1, primary (α=0.05); test 2, CFQ-R resp domain (Wk24) and sweat chloride (Wk24)(α=0.05).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline values of age and percent predicted FEV1.||12.6|8.6|<0.0001
71858893|NCT00909532|143231802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|8.5|12.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||Analysis of this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were obtained from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for the continuous baseline values of age and percent predicted forced expiratory volume in 1 second (FEV1),using unstructured covariance matrix.||12.5|8.5|<0.0001
71906554|NCT01337167|143335397|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-0.3|2.4|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal \>=39.5°C||2.4|-0.3|
71858894|NCT00909532|143231803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|4.7|11.4||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||Through Week 24: Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, domain score, and percent predicted FEV1, using unstructured covariance matrix.||11.4|4.7|<0.0001
71858895|NCT00909532|143231803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|5.3|11.9||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for the CFQ-R respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age,sweat chloride, and percent predicted FEV1,using unstructured covariance matrix.||11.9|5.3|<0.0001
71858896|NCT00909532|143231804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.9|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.3|-44.5||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.5|-51.3|<0.0001
71858897|NCT00909532|143231804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.0001|TWO_SIDED|95.0|-51.5|-44.7||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.||-44.7|-51.5|<0.0001
71858898|NCT00909532|143231805|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at Week 24|0.4||||0.0016|TWO_SIDED|95.0|0.23|0.71||There was no adjustment for multiple comparisons.|Regression, Cox|||Time to first pulmonary exacerbation through Week 24 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.71|0.23|0.0016
71858899|NCT00909532|143231805|SUPERIORITY_OR_OTHER||Cox Proportional Hazard at 48 Weeks|0.46||||0.0012|TWO_SIDED|95.0|0.28|0.73||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg's on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Regression, Cox|||Time to first pulmonary exacerbation through Week 48 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.||0.73|0.28|0.0012
71858900|NCT00909532|143231806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|1.8|3.7|||Mixed Models Analysis|There was no adjustment for multiple comparisons.||At Week 24: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect, and intercept, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||3.7|1.8|<0.0001
71858901|NCT00909532|143231806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|0.7||0.0001|TWO_SIDED|95.0|1.3|4.1||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg's step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect and visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.1|1.3|0.0001
71858902|NCT00859976|143231807|SUPERIORITY|A superiority test was used to calculate the number of patients that are needed in order to show a difference between the bone mineral density surrounding BoneMaster coated cups compared to plasma HA sprayed cups.||||||0.457|||||||Wilcoxon (Mann-Whitney)|Change in bone mineral density, normalised to baseline levels.||||||0.4570
71858903|NCT00984698|143231824|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
71858904|NCT00984698|143231825|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm||||<.05
71858905|NCT03029819|143231840|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||.52
71858906|NCT01536197|143231863|SUPERIORITY_OR_OTHER|||||||0.19|||||||ANOVA|Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).||||||0.19
71858907|NCT03559829|143231868|OTHER|||||||0.025|||||||paired t-test|||||||0.025
71858908|NCT03559829|143231869|OTHER|||||||0.01|||||||paired t-test|||||||0.01
71858909|NCT03559829|143231870|OTHER|||||||0.3|||||||paired t-test|||||||0.3
71858910|NCT03559829|143231871|OTHER|||||||0.098|||||||paired t-test|||||||0.098
71858911|NCT03559829|143231872|OTHER|||||||0.2|||||||paired t-test|||||||0.2
71858912|NCT03559829|143231873|OTHER|||||||0.07|||||||paired t-test|||||||0.07
71858913|NCT01024036|143232009|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0012|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0012
71858914|NCT01024036|143232009|SUPERIORITY_OR_OTHER||difference in the response rate|34.0||||0.0004|TWO_SIDED|95.0|11.1|54.8|||Fisher Exact|Without adjusting for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms||54.8|11.1|0.0004
71858915|NCT01024036|143232011|SUPERIORITY_OR_OTHER||Difference in overall response rates|33.9||||0.0022|TWO_SIDED|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|||||54.8|11.1|0.0022
71858916|NCT01024036|143232013|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.418||||0.0084|TWO_SIDED|95.0|0.214|0.815|||Log Rank||Hazard ratio and 95% CI from a Cox proportional hazards model|||0.815|0.214|0.0084
71858917|NCT01024036|143232014|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|61.3||||0.0002|TWO_SIDED|95.0|28.3|85.1|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||85.1|28.3|0.0002
71858918|NCT01024036|143232015|SUPERIORITY_OR_OTHER||Difference of hemoglobin response rates|41.9||||0.0195|TWO_SIDED|95.0|7.8|70.7|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care \[BSC\] arm minus hemoglobin response rate for Placebo+BSC arm.|||70.7|7.8|0.0195
71858919|NCT03459612|143232021|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in Least Square (LS) means \< 4.4.|Difference in LS Means|0.98|||<|0.0001|TWO_SIDED|95.0|-0.43|2.39|||Mixed Models Analysis|||||2.39|-0.43|<0.0001
71858920|NCT03459612|143232021|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|0.32|3.2|||Mixed Models Analysis|||||3.20|0.32|<0.0001
71858921|NCT03459612|143232021|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|LS Means|4.98|||<|0.0001|TWO_SIDED|95.0|3.58|6.38|||Mixed Models Analysis|||||6.38|3.58|<0.0001
71858922|NCT03459612|143232022|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.12|||<|0.0001|TWO_SIDED|95.0|-1.28|1.04|||Mixed Models Analysis|||||1.04|-1.28|<0.0001
71858923|NCT03459612|143232022|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-0.32|||<|0.0001|TWO_SIDED|95.0|-1.51|0.88|||Mixed Models Analysis|||||0.88|-1.51|<0.0001
71858924|NCT03459612|143232022|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.31|||<|0.0001|TWO_SIDED|95.0|3.17|5.45|||Mixed Models Analysis|||||5.45|3.17|<0.0001
71858925|NCT03459612|143232023|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Differnce in LS Means|-0.97|||<|0.0001|TWO_SIDED|95.0|-2.3|0.36|||Mixed Models Analysis|||||0.36|-2.30|<0.0001
71858926|NCT03459612|143232023|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|-1.04|||<|0.0001|TWO_SIDED|95.0|-2.4|0.32|||Mixed Models Analysis|||||0.32|-2.40|<0.0001
71858927|NCT03459612|143232023|NON_INFERIORITY|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means \< 4.4.|Difference in LS Means|4.05|||<|0.0001|TWO_SIDED|95.0|2.73|5.38|||Mixed Models Analysis|||||5.38|2.73|<0.0001
71858928|NCT03459612|143232024|SUPERIORITY||Differences of Least Square Mean|0.28|||||TWO_SIDED|95.0|-0.15|0.7||||||||0.70|-0.15|
71858929|NCT03459612|143232024|SUPERIORITY||Difference of Least Square Means|0.66|||||TWO_SIDED|95.0|0.22|1.1||||||||1.10|0.22|
71858930|NCT03459612|143232024|SUPERIORITY||Difference of Least Square Means|0.81|||||TWO_SIDED|95.0|0.39|1.24||||||||1.24|0.39|
71858931|NCT03459612|143232025|SUPERIORITY||Difference of Least Square Means|0.48|||||TWO_SIDED|95.0|0.0|0.96||||||||0.96|0.00|
71858932|NCT03459612|143232025|SUPERIORITY||Differnce of Least Square Means|0.34|||||TWO_SIDED|95.0|-0.14|0.82||||||||0.82|-0.14|
71858933|NCT03459612|143232025|SUPERIORITY||Difference of Least Square Means|1.29|||||TWO_SIDED|95.0|0.81|1.78||||||||1.78|0.81|
71858934|NCT03459612|143232026|SUPERIORITY||Difference of Least Square Means|-0.58|||||TWO_SIDED|95.0|-1.1|-0.06||||||||-0.06|-1.10|
71858935|NCT03459612|143232026|SUPERIORITY||Difference of Least Square Means|-0.4|||||TWO_SIDED|95.0|-0.89|0.09||||||||0.09|-0.89|
71858936|NCT03459612|143232026|SUPERIORITY||Difference of Least Square Means|0.44|||||TWO_SIDED|95.0|-0.09|0.96||||||||0.96|-0.09|
71858937|NCT03459612|143232027|SUPERIORITY||Difference in Least Square Means|0.0|||||TWO_SIDED|95.0|-1.61|1.62||||||||1.62|-1.61|
71858938|NCT03459612|143232027|SUPERIORITY||Difference in Lease Square Means|-0.74|||||TWO_SIDED|95.0|-2.49|1.01||||||||1.01|-2.49|
71858939|NCT03459612|143232027|SUPERIORITY||Difference in Least Square Means|-0.72|||||TWO_SIDED|95.0|-2.32|0.89||||||||0.89|-2.32|
71858940|NCT03459612|143232028|SUPERIORITY||Difference of Least Square Means|-1.79|||||TWO_SIDED|95.0|-3.52|-0.06||||||||-0.06|-3.52|
71858941|NCT03459612|143232028|SUPERIORITY||Difference in Least Square Means|-0.29|||||TWO_SIDED|95.0|-2.0|1.42||||||||1.42|-2.00|
71858942|NCT03459612|143232028|SUPERIORITY||Difference in Least Square Means|-3.81|||||TWO_SIDED|95.0|-5.53|-2.08||||||||-2.08|-5.53|
71858943|NCT03459612|143232029|SUPERIORITY||Difference of Least Square Means|-0.28|||||TWO_SIDED|95.0|-1.71|1.15||||||||1.15|-1.71|
71858944|NCT03459612|143232029|SUPERIORITY||Difference of Least Square Means|-0.31|||||TWO_SIDED|95.0|-1.71|1.08||||||||1.08|-1.71|
71858945|NCT03459612|143232029|SUPERIORITY||Difference of Least Square Means|-2.7|||||TWO_SIDED|95.0|-4.13|-1.27||||||||-1.27|-4.13|
71858946|NCT03459612|143232030|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.3||0.6875|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.6875
71858947|NCT03459612|143232030|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.27||0.375|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.3750
71858948|NCT03459612|143232030|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|1.0||0.0115|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0115
71858949|NCT03459612|143232031|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.42||0.1563|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1563
71858950|NCT03459612|143232031|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.44||0.5938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.5938
71858951|NCT03459612|143232031|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|0.54||0.0938|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0938
71858952|NCT03459612|143232032|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.56||0.125|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.1250
71858953|NCT03459612|143232032|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.94||0.959|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.9590
71858954|NCT03459612|143232032|SUPERIORITY||Mean Difference (Final Values)|0.46|STANDARD_DEVIATION|1.76||0.0097|TWO_SIDED||||||Wilcoxon Signed Rank test|||||||0.0097
71858955|NCT01817712|143232043|SUPERIORITY||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.46|3.14|||Regression, Logistic|||||3.14|1.46|<0.001
71858956|NCT01817712|143232044|SUPERIORITY|||||||0.004|||||||Kruskal-Wallis|Site used as strata||||||0.004
71858957|NCT01817712|143232045|OTHER|Longitudinal analysis of PCL-5 (change from baseline)|Mean Difference (Net)|-1.9||||0.07|TWO_SIDED|95.0|-3.91|0.12|||Mixed Models Analysis|||||0.12|-3.91|0.07
71858958|NCT02034162|143232177|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71858959|NCT02034162|143232178|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||< 0.001
71858960|NCT02034162|143232180|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71858961|NCT02034162|143232181|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||< 0.001
71858962|NCT04702893|143232255|OTHER|No formal hypotheses were tested.||||||0.1185|||||||Z-test of correlation|||||||0.1185
71858963|NCT04702893|143232256|OTHER|No formal hypotheses were tested.||||||0.5135|||||||Z-test of correlation|||||||0.5135
71858964|NCT04702893|143232257|OTHER|No formal hypotheses were tested.||||||0.0764|||||||Z-test of correlation|||||||0.0764
71858965|NCT04702893|143232258|OTHER|No formal hypotheses were tested.||||||0.3478|||||||Z-test of correlation|||||||0.3478
71858966|NCT03831854|143232263|SUPERIORITY||Median Difference (Final Values)|0.0||||0.08|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.08
71858967|NCT03831854|143232264|SUPERIORITY|||||||0.11|||||||Fisher Exact|The relative risk could not be assessed due to zero incidence in the treatment group||||||0.11
71858968|NCT03831854|143232265|SUPERIORITY||Median Difference (Final Values)|-2.3||||0.63|TWO_SIDED|98.5|-9.5|5.0|||Wilcoxon (Mann-Whitney)|||||5.0|-9.5|0.63
71858969|NCT03831854|143232266|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.58|TWO_SIDED|98.3|-1.7|2.6|||t-test, 2 sided|||||2.6|-1.7|0.58
71858970|NCT03831854|143232267|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|98.3|0.3|3.8|||Chi-squared|||||3.8|0.3|1.0
71858971|NCT03305809|143232272|SUPERIORITY||Posterior Mean Difference|-0.89|||||TWO_SIDED|95.0|-2.776|0.969|||||Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.|||0.969|-2.776|
71858972|NCT03305809|143232272|SUPERIORITY||Posterior Mean Difference|-0.08|||||TWO_SIDED|95.0|-1.996|1.879|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.879|-1.996|
71858973|NCT03305809|143232272|SUPERIORITY||Posterior Mean Difference|-0.78|||||TWO_SIDED|95.0|-2.873|1.277|||||Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.|||1.277|-2.873|
71858974|NCT03305809|143232273|SUPERIORITY||Mean Difference (Net)|-0.2||||0.273|TWO_SIDED|95.0|-0.54|0.15|||Mixed Models Analysis|||||0.15|-0.54|0.273
71858975|NCT03305809|143232273|SUPERIORITY||Mean Difference (Net)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.02|-0.3|||Mixed Models Analysis|||||-0.30|-1.02|<0.001
71858976|NCT03305809|143232273|SUPERIORITY||Mean Difference (Net)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.29|-0.53|||Mixed Models Analysis|||||-0.53|-1.29|< 0.001
71858977|NCT03305809|143232274|SUPERIORITY||Mean Difference (Net)|-70.71|STANDARD_ERROR_OF_MEAN|68.495||0.303|TWO_SIDED|95.0|-205.53|64.11|||Mixed Models Analysis|||||64.11|-205.53|0.303
71858978|NCT03305809|143232274|SUPERIORITY||Median Difference (Net)|-107.02|STANDARD_ERROR_OF_MEAN|69.647||0.125|TWO_SIDED|95.0|-244.09|30.06|||Mixed Models Analysis|||||30.06|-244.09|0.125
71858979|NCT03305809|143232274|SUPERIORITY||Mean Difference (Net)|-123.72|STANDARD_ERROR_OF_MEAN|72.892||0.091|TWO_SIDED|95.0|-267.18|19.74|||Mixed Models Analysis|||||19.74|-267.18|0.091
71858980|NCT03305809|143232275|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.985||0.686|TWO_SIDED|95.0|-2.34|1.54|||Mixed Models Analysis|||||1.54|-2.34|0.686
71858981|NCT03305809|143232275|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.011||0.485|TWO_SIDED|95.0|-2.7|1.28|||Mixed Models Analysis|||||1.28|-2.70|0.485
71858982|NCT03305809|143232275|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|1.064||0.406|TWO_SIDED|95.0|-2.98|1.21|||Mixed Models Analysis|||||1.21|-2.98|0.406
71858983|NCT03305809|143232276|SUPERIORITY||Mean Difference (Net)|0.44|STANDARD_ERROR_OF_MEAN|0.603||0.464|TWO_SIDED|95.0|-0.74|1.63|||Mixed Models Analysis|||||1.63|-0.74|0.464
71858984|NCT03305809|143232276|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.623||0.72|TWO_SIDED|95.0|-1.0|1.45|||Mixed Models Analysis|||||1.45|-1.00|0.720
71858985|NCT03305809|143232276|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.655||0.149|TWO_SIDED|95.0|-0.34|2.24|||Mixed Models Analysis|||||2.24|-0.34|0.149
71858986|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.62|STANDARD_ERROR_OF_MEAN|1.213||0.607|TWO_SIDED|95.0|-3.01|1.76|||Mixed Models Analysis|||Total Score||1.76|-3.01|0.607
71858987|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.265||0.18|TWO_SIDED|95.0|-4.19|0.79|||Mixed Models Analysis|||Total Score||0.79|-4.19|0.180
71858988|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.75|STANDARD_ERROR_OF_MEAN|1.325||0.572|TWO_SIDED|95.0|-3.36|1.86|||Mixed Models Analysis|||Total Score||1.86|-3.36|0.572
71858989|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.173||0.32|TWO_SIDED|95.0|-0.51|0.17|||Mixed Models Analysis|||Delusions||0.17|-0.51|0.320
71858990|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.037|TWO_SIDED|95.0|-0.73|-0.02|||Mixed Models Analysis|||Delusions||-0.02|-0.73|0.037
71858991|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.558|TWO_SIDED|95.0|-0.49|0.26|||Mixed Models Analysis|||Delusions||0.26|-0.49|0.558
71858992|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.182||0.924|TWO_SIDED|95.0|-0.38|0.34|||Mixed Models Analysis|||Hallucinations||0.34|-0.38|0.924
71858993|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.189||0.061|TWO_SIDED|95.0|-0.73|0.02|||Mixed Models Analysis|||Hallucinations||0.02|-0.73|0.061
71858994|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.199||0.148|TWO_SIDED|95.0|-0.68|0.1|||Mixed Models Analysis|||Hallucinations||0.10|-0.68|0.148
71858995|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.18||0.552|TWO_SIDED|95.0|-0.46|0.25|||Mixed Models Analysis|||Agitation/Aggression||0.25|-0.46|0.552
71858996|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.188||0.735|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Agitation/Aggression||0.31|-0.43|0.735
71858997|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.197||0.224|TWO_SIDED|95.0|-0.63|0.15|||Mixed Models Analysis|||Agitation/Aggression||0.15|-0.63|0.224
71858998|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.216||0.783|TWO_SIDED|95.0|-0.37|0.48|||Mixed Models Analysis|||Depression/Dysphoria||0.48|-0.37|0.783
71858999|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.226||0.64|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.55|0.640
71859000|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.236||0.592|TWO_SIDED|95.0|-0.59|0.34|||Mixed Models Analysis|||Depression/Dysphoria||0.34|-0.59|0.592
71859001|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.197||0.993|TWO_SIDED|95.0|-0.39|0.39|||Mixed Models Analysis|||Anxiety||0.39|-0.39|0.993
71859002|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.205||0.29|TWO_SIDED|95.0|-0.19|0.62|||Mixed Models Analysis|||Anxiety||0.62|-0.19|0.290
71859003|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.215||0.722|TWO_SIDED|95.0|-0.5|0.35|||Mixed Models Analysis|||Anxiety||0.35|-0.50|0.722
71859004|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.097||0.246|TWO_SIDED|95.0|-0.3|0.08|||Mixed Models Analysis|||Elation/Euphoria||0.08|-0.30|0.246
71859005|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.101||0.175|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||Elation/Euphoria||0.06|-0.34|0.175
71859006|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.106||0.482|TWO_SIDED|95.0|-0.28|0.13|||Mixed Models Analysis|||Elation/Euphoria||0.13|-0.28|0.482
71859007|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.266||0.091|TWO_SIDED|95.0|-0.97|0.07|||Mixed Models Analysis|||Apathy/Indifference||0.07|-0.97|0.091
71859008|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.278||0.248|TWO_SIDED|95.0|-0.87|0.23|||Mixed Models Analysis|||Apathy/Indifference||0.23|-0.87|0.248
71859009|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.29||0.516|TWO_SIDED|95.0|-0.76|0.38|||Mixed Models Analysis|||Apathy/Indifference||0.38|-0.76|0.516
71859010|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.114||0.875|TWO_SIDED|95.0|-0.21|0.24|||Mixed Models Analysis|||Disinhibition||0.24|-0.21|0.875
71859011|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.119||0.005|TWO_SIDED|95.0|0.1|0.57|||Mixed Models Analysis|||Disinhibition||0.57|0.10|0.005
71859012|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.125||0.761|TWO_SIDED|95.0|-0.21|0.28|||Mixed Models Analysis|||Disinhibition||0.28|-0.21|0.761
71859013|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.181||0.183|TWO_SIDED|95.0|-0.6|0.12|||Mixed Models Analysis|||Irritability/Lability||0.12|-0.60|0.183
71859014|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.189||0.765|TWO_SIDED|95.0|-0.43|0.31|||Mixed Models Analysis|||Irritability/Lability||0.31|-0.43|0.765
71859015|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.198||0.279|TWO_SIDED|95.0|-0.18|0.61|||Mixed Models Analysis|||Irritability/Lability||0.61|-0.18|0.279
71859016|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.147||0.252|TWO_SIDED|95.0|-0.12|0.46|||Mixed Models Analysis|||Aberrant Motor Behavior||0.46|-0.12|0.252
71859017|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.154||0.526|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Aberrant Motor Behavior||0.20|-0.40|0.526
71859018|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.161||0.8|TWO_SIDED|95.0|-0.28|0.36|||Mixed Models Analysis|||Aberrant Motor Behavior||0.36|-0.28|0.800
71859019|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.623|TWO_SIDED|95.0|-0.59|0.98|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.98|-0.59|0.623
71859020|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.418||0.354|TWO_SIDED|95.0|-1.21|0.44|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.44|-1.21|0.354
71859021|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.437||0.809|TWO_SIDED|95.0|-0.97|0.75|||Mixed Models Analysis|||Sleep/Nighttime Behavior Disorders||0.75|-0.97|0.809
71859022|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.376||0.79|TWO_SIDED|95.0|-0.84|0.64|||Mixed Models Analysis|||Appetite/Eating Disorders||0.64|-0.84|0.790
71859023|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.392||0.28|TWO_SIDED|95.0|-1.2|0.35|||Mixed Models Analysis|||Appetite/Eating Disorders||0.35|-1.20|0.280
71859024|NCT03305809|143232277|SUPERIORITY||Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.412||0.797|TWO_SIDED|95.0|-0.7|0.92|||Mixed Models Analysis|||Appetite/Eating Disorders||0.92|-0.70|0.797
71859025|NCT03305809|143232278|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.247|TWO_SIDED|95.0|-1.91|0.49|||Mixed Models Analysis|||||0.49|-1.91|0.247
71859026|NCT03305809|143232278|SUPERIORITY||Mean Difference (Net)|-0.88|STANDARD_ERROR_OF_MEAN|0.631||0.164|TWO_SIDED|95.0|-2.12|0.36|||Mixed Models Analysis|||||0.36|-2.12|0.164
71859027|NCT03305809|143232278|SUPERIORITY||Mean Difference (Net)|-1.59|STANDARD_ERROR_OF_MEAN|0.663||0.017|TWO_SIDED|95.0|-2.9|-0.29|||Mixed Models Analysis|||||-0.29|-2.90|0.017
71859028|NCT03305809|143232279|SUPERIORITY||Mean Difference (Net)|-6.41|STANDARD_ERROR_OF_MEAN|2.86||0.026|TWO_SIDED|95.0|-12.04|-0.77|||Mixed Models Analysis|||||-0.77|-12.04|0.026
71859029|NCT03305809|143232279|SUPERIORITY||Mean Difference (Net)|-7.39|STANDARD_ERROR_OF_MEAN|2.969||0.014|TWO_SIDED|95.0|-13.24|-1.53|||Mixed Models Analysis|||||-1.53|-13.24|0.014
71859030|NCT03305809|143232279|SUPERIORITY||Mean Difference (Net)|-10.6|STANDARD_ERROR_OF_MEAN|3.104|<|0.001|TWO_SIDED|95.0|-16.72|-4.48|||Mixed Models Analysis|||||-4.48|-16.72|<0.001
71859031|NCT03305809|143232280|SUPERIORITY||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|1.362||0.683|TWO_SIDED|95.0|-2.13|3.24|||Mixed Models Analysis|||||3.24|-2.13|0.683
71859032|NCT03305809|143232280|SUPERIORITY||Mean Difference (Net)|2.41|STANDARD_ERROR_OF_MEAN|1.413||0.089|TWO_SIDED|95.0|-0.37|5.19|||Mixed Models Analysis|||||5.19|-0.37|0.089
71859033|NCT03305809|143232280|SUPERIORITY||Mean Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|1.489||0.294|TWO_SIDED|95.0|-1.37|4.49|||Mixed Models Analysis|||||4.49|-1.37|0.294
71859034|NCT03305809|143232281|SUPERIORITY||Mean Difference (Net)|0.63|STANDARD_ERROR_OF_MEAN|0.389||0.105|TWO_SIDED|95.0|-0.13|1.4|||Mixed Models Analysis|||||1.40|-0.13|0.105
71859035|NCT03305809|143232281|SUPERIORITY||Mean Difference (Net)|1.07|STANDARD_ERROR_OF_MEAN|0.406||0.009|TWO_SIDED|95.0|0.27|1.87|||Mixed Models Analysis|||||1.87|0.27|0.009
71859036|NCT03305809|143232281|SUPERIORITY||Mean Difference (Net)|0.49|STANDARD_ERROR_OF_MEAN|0.428||0.253|TWO_SIDED|95.0|-0.35|1.33|||Mixed Models Analysis|||||1.33|-0.35|0.253
71859037|NCT03305809|143232282|SUPERIORITY||Mean Difference (Net)|-1.74|STANDARD_ERROR_OF_MEAN|0.923||0.061|TWO_SIDED|95.0|-3.56|0.08|||Mixed Models Analysis|||Motor Experiences of Daily Living||0.08|-3.56|0.061
71859038|NCT03305809|143232282|SUPERIORITY||Mean Difference (Net)|-2.37|STANDARD_ERROR_OF_MEAN|0.96||0.014|TWO_SIDED|95.0|-4.26|-0.47|||Mixed Models Analysis|||Motor Experiences of Daily Living||-0.47|-4.26|0.014
71859039|NCT03305809|143232282|SUPERIORITY||Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|1.013|<|0.001|TWO_SIDED|95.0|-5.5|-1.51|||Mixed Models Analysis|||Motor Experiences of Daily Living||-1.51|-5.50|<0.001
71859040|NCT03305809|143232282|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.822||0.074|TWO_SIDED|95.0|-6.86|0.32|||Mixed Models Analysis|||Motor Exam||0.32|-6.86|0.074
71859041|NCT03305809|143232282|SUPERIORITY||Mean Difference (Net)|-3.27|STANDARD_ERROR_OF_MEAN|1.891||0.085|TWO_SIDED|95.0|-7.0|0.45|||Mixed Models Analysis|||Motor Exam||0.45|-7.00|0.085
71859042|NCT03305809|143232282|SUPERIORITY||Mean Difference (Net)|-4.23|STANDARD_ERROR_OF_MEAN|1.959||0.032|TWO_SIDED|95.0|-8.09|-0.37|||Mixed Models Analysis|||Motor Exam||-0.37|-8.09|0.032
71859043|NCT03305809|143232284|SUPERIORITY||Mean Difference (Net)|0.3||||0.898|TWO_SIDED|95.0|-4.92|5.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.61|-4.92|0.898
71859044|NCT03305809|143232284|SUPERIORITY||Mean Difference (Net)|0.6||||0.821|TWO_SIDED|95.0|-4.71|5.94|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||5.94|-4.71|0.821
71859045|NCT03305809|143232284|SUPERIORITY||Mean Difference (Net)|9.4|||<|0.001|TWO_SIDED|95.0|4.11|14.61|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||14.61|4.11|<0.001
71859046|NCT03305809|143232284|SUPERIORITY||Mean Difference (Net)|0.3||||0.805|TWO_SIDED|95.0|-2.4|3.08|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.08|-2.40|0.805
71859047|NCT03305809|143232284|SUPERIORITY||Mean Difference (Net)|0.9||||0.513|TWO_SIDED|95.0|-1.85|3.69|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.69|-1.85|0.513
71859048|NCT03305809|143232284|SUPERIORITY||Mean Difference (Net)|3.6||||0.011|TWO_SIDED|95.0|0.83|6.28|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||6.28|0.83|0.011
71859049|NCT03305809|143232285|SUPERIORITY||Mean Difference (Net)|2.5||||0.065|TWO_SIDED|95.0|-0.16|5.08|||Mixed Models Analysis|||||5.08|-0.16|0.065
71859050|NCT03305809|143232285|SUPERIORITY||Mean Difference (Net)|3.6||||0.008|TWO_SIDED|95.0|0.93|6.21|||Mixed Models Analysis|||||6.21|0.93|0.008
71859051|NCT03305809|143232285|SUPERIORITY||Mean Difference (Net)|8.7|||<|0.001|TWO_SIDED|95.0|6.06|11.27|||Mixed Models Analysis|||||11.27|6.06|<0.001
71859052|NCT03305809|143232286|SUPERIORITY||Mean Difference (Net)|1.6||||0.339|TWO_SIDED|95.0|-1.72|4.99|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.99|-1.72|0.339
71859053|NCT03305809|143232286|SUPERIORITY||Mean Difference (Net)|1.2||||0.486|TWO_SIDED|95.0|-2.26|4.73|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||4.73|-2.26|0.486
71859054|NCT03305809|143232286|SUPERIORITY||Mean Difference (Net)|4.2||||0.024|TWO_SIDED|95.0|0.56|7.81|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||7.81|0.56|0.024
71859055|NCT03305809|143232286|SUPERIORITY||Mean Difference (Net)|-0.1||||0.935|TWO_SIDED|95.0|-2.04|1.88|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.88|-2.04|0.935
71859056|NCT03305809|143232286|SUPERIORITY||Mean Difference (Net)|0.7||||0.505|TWO_SIDED|95.0|-1.34|2.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||2.72|-1.34|0.505
71859057|NCT03305809|143232286|SUPERIORITY||Mean Difference (Net)|1.22||||0.266|TWO_SIDED|95.0|-0.91|3.3|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.30|-0.91|0.266
71859058|NCT03305809|143232287|SUPERIORITY||Mean Difference (Net)|0.6||||0.55|TWO_SIDED|95.0|-1.28|2.41|||Mixed Models Analysis|||||2.41|-1.28|0.550
71859059|NCT03305809|143232287|SUPERIORITY||Mean Difference (Net)|1.8||||0.069|TWO_SIDED|95.0|-0.14|3.68|||Mixed Models Analysis|||||3.68|-0.14|0.069
71859060|NCT03305809|143232287|SUPERIORITY||Mean Difference (Net)|2.9||||0.005|TWO_SIDED|95.0|0.89|4.83|||Mixed Models Analysis|||||4.83|0.89|0.005
71859061|NCT03305809|143232288|SUPERIORITY||Mean Difference (Net)|-7.0||||0.045|TWO_SIDED|95.0|-13.92|-0.15|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||-0.15|-13.92|0.045
71859062|NCT03305809|143232288|SUPERIORITY||Mean Difference (Net)|3.1||||0.39|TWO_SIDED|95.0|-4.05|10.32|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||10.32|-4.05|0.390
71859063|NCT03305809|143232288|SUPERIORITY||Mean Difference (Net)|-1.1||||0.768|TWO_SIDED|95.0|-8.32|6.16|||Mixed Models Analysis|||Sitting Systolic Blood Pressure||6.16|-8.32|0.768
71859064|NCT03305809|143232288|SUPERIORITY||Mean Difference (Net)|-4.3||||0.041|TWO_SIDED|95.0|-8.48|-0.17|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||-0.17|-8.48|0.041
71859065|NCT03305809|143232288|SUPERIORITY||Mean Difference (Net)|-0.5||||0.802|TWO_SIDED|95.0|-4.81|3.72|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||3.72|-4.81|0.802
71859066|NCT03305809|143232288|SUPERIORITY||Mean Difference (Net)|-2.4||||0.284|TWO_SIDED|95.0|-6.67|1.97|||Mixed Models Analysis|||Sitting Diastolic Blood Pressure||1.97|-6.67|0.284
71859067|NCT03305809|143232289|SUPERIORITY||Mean Difference (Net)|0.0||||0.996|TWO_SIDED|95.0|-4.17|4.19|||Mixed Models Analysis|||||4.19|-4.17|0.996
71859068|NCT03305809|143232289|SUPERIORITY||Mean Difference (Net)|-0.7||||0.767|TWO_SIDED|95.0|-4.99|3.69|||Mixed Models Analysis|||||3.69|-4.99|0.767
71859069|NCT03305809|143232289|SUPERIORITY||Mean Difference (Net)|-0.6||||0.791|TWO_SIDED|95.0|-4.96|3.79|||Mixed Models Analysis|||||3.79|-4.96|0.791
71859070|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|0.98||||0.312|TWO_SIDED|95.0|-0.93|2.88|||ANCOVA|||Week 12||2.88|-0.93|0.312
71859071|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|1.03||||0.289|TWO_SIDED|95.0|-0.89|2.95|||ANCOVA|||Week 12||2.95|-0.89|0.289
71859072|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|1.56||||0.141|TWO_SIDED|95.0|-0.53|3.65|||ANCOVA|||Week 12||3.65|-0.53|0.141
71859073|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|0.06||||0.954|TWO_SIDED|95.0|-1.89|2.01|||ANCOVA|||Week 12||2.01|-1.89|0.954
71859074|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|0.59||||0.584|TWO_SIDED|95.0|-1.53|2.7|||ANCOVA|||||2.70|-1.53|0.584
71859075|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|0.53||||0.623|TWO_SIDED|95.0|-1.59|2.65|||ANCOVA|||Week 12||2.65|-1.59|0.623
71859076|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|1.39||||0.256|TWO_SIDED|95.0|-1.02|3.79|||ANCOVA|||Follow-up||3.79|-1.02|0.256
71859077|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|1.41||||0.258|TWO_SIDED|95.0|-1.04|3.86|||ANCOVA|||Follow-up||3.86|-1.04|0.258
71859078|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|4.59|||<|0.001|TWO_SIDED|95.0|1.93|7.25|||ANCOVA|||Follow-up||7.25|1.93|<0.001
71859079|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|0.02||||0.988|TWO_SIDED|95.0|-2.47|2.51|||ANCOVA|||Follow-up||2.51|-2.47|0.988
71859080|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|3.2||||0.02|TWO_SIDED|95.0|0.51|5.9|||ANCOVA|||Follow-up||5.90|0.51|0.020
71859081|NCT03305809|143232290|SUPERIORITY||Mean Difference (Net)|3.18||||0.022|TWO_SIDED|95.0|0.46|5.91|||ANCOVA|||Follow-up||5.91|0.46|0.022
71859082|NCT00816556|143232292|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||Dryness severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.42
71859083|NCT00816556|143232292|SUPERIORITY_OR_OTHER|||||||0.22|||||||ANOVA|||Dryness bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.22
71859084|NCT00816556|143232292|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANOVA|||Itching severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.37
71859085|NCT00816556|143232292|SUPERIORITY_OR_OTHER|||||||0.27|||||||ANOVA|||Itching bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.27
71859086|NCT00816556|143232292|SUPERIORITY_OR_OTHER|||||||0.46|||||||ANOVA|||Burning severity: P-value for the global F-test testing for all treatment arm effects equal.||||0.46
71859087|NCT00816556|143232292|SUPERIORITY_OR_OTHER|||||||0.67|||||||ANOVA|||Burning bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.||||0.67
71859088|NCT00816556|143232293|SUPERIORITY_OR_OTHER|||||||0.33|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.33
71859089|NCT00816556|143232293|SUPERIORITY_OR_OTHER|||||||0.99|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.99
71859090|NCT00816556|143232293|SUPERIORITY_OR_OTHER|||||||0.58|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.58
71859091|NCT00816556|143232294|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.||||0.007
71859092|NCT00816556|143232294|SUPERIORITY_OR_OTHER|||||||0.32|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.32
71859093|NCT00816556|143232294|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.||||0.02
71859094|NCT03546816|143232295|SUPERIORITY|||||||0.229||||||P-value from a Cochran-Mantel-Haenszel (CMH) test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.229
71859095|NCT03546816|143232296|SUPERIORITY|||||||0.013||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.013
71859096|NCT03546816|143232297|SUPERIORITY|||||||0.236||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||||||0.236
71859097|NCT03546816|143232298|SUPERIORITY|||||||0.083||||||P-values, least squares means (LS Mean) and standard deviations (LS SD) from an analysis of covariance (ANCOVA) with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.083
71859098|NCT03546816|143232298|SUPERIORITY|||||||0.049||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.049
71859099|NCT03546816|143232298|SUPERIORITY|||||||0.081||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 6||||0.081
71859100|NCT03546816|143232298|SUPERIORITY|||||||0.157||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.157
71859101|NCT03546816|143232299|SUPERIORITY|||||||0.151||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 2||||0.151
71859102|NCT03546816|143232299|SUPERIORITY|||||||0.052||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 4||||0.052
71859103|NCT03546816|143232299|SUPERIORITY|||||||0.175||||||P-value from a CMH test stratified by Baseline WI-NRS used for randomization stratification. Value has been adjusted for multiple imputation.|Cochran-Mantel-Haenszel|||At Week 10||||0.175
71859104|NCT03546816|143232300|SUPERIORITY|||||||0.475||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.475
71859105|NCT03546816|143232300|SUPERIORITY|||||||0.02||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.020
71859106|NCT03546816|143232300|SUPERIORITY|||||||0.492||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.492
71859107|NCT03546816|143232301|SUPERIORITY|||||||0.175||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 2||||0.175
71859108|NCT03546816|143232301|SUPERIORITY|||||||0.169||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 4||||0.169
71859109|NCT03546816|143232301|SUPERIORITY|||||||0.516||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.516
71859110|NCT03546816|143232302|SUPERIORITY|||||||0.814||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.814
71859111|NCT03546816|143232303|SUPERIORITY|||||||0.113||||||P-values, LS mean and SD from ANCOVA with treatment group and stratification factor as fixed effects, and baseline value as a covariate.|ANCOVA|||At Week 10||||0.113
71859112|NCT01161446|143232333|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71859113|NCT01161446|143232334|NON_INFERIORITY|Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.61|1.9|||Regression, Logistic|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.90|0.61|
71859114|NCT01161446|143232335|NON_INFERIORITY|Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.|Difference in proportions|-0.068|||||TWO_SIDED|95.0|-0.16|0.016||||||||0.016|-0.16|
71859115|NCT01161446|143232336|NON_INFERIORITY|Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.|Incidence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.64|1.33|||Poisson regression|Used generalized estimating equations with exchangeable working correlation and robust standard errors to account for repeated measures.|The home testing arm represents the numerator and the standard testing arm the denominator.|||1.33|0.64|
71859116|NCT01006616|143232381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.031||||0.325|TWO_SIDED|95.0|-0.03|0.091|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and inhaled corticosteroid (ICS) use (yes/no)||||0.091|-0.030|0.325
71859117|NCT01006616|143232381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.029||||0.37|TWO_SIDED|95.0|-0.091|0.034|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.034|-0.091|0.370
71859118|NCT01006616|143232381|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.037|TWO_SIDED|95.0|0.004|0.131|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)||||0.131|0.004|0.037
71859119|NCT01006616|143232382|SUPERIORITY_OR_OTHER||Difference in percentages|2.6||||0.096|TWO_SIDED|95.0|-0.6|6.9|||Miettinen and Nurminen||Analysis of Week 26 data|||6.9|-0.6|0.096
71859120|NCT01006616|143232382|SUPERIORITY_OR_OTHER||Difference in percentages|12.2|||<|0.001|TWO_SIDED|95.0|7.4|18.4|||Miettinen and Nurminen||Analysis of Week 26 data|||18.4|7.4|<0.001
71859121|NCT01006616|143232382|SUPERIORITY_OR_OTHER||Difference in percentages|19.7|||<|0.001|TWO_SIDED|95.0|13.8|26.9|||Miettinen and Nurminen||Analysis of Week 26 data|||26.9|13.8|<0.001
71859122|NCT03672175|143232413|SUPERIORITY||Least Square (LS) Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.85||0.6638|TWO_SIDED|95.0|-2.0|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Mixed effect model for repeated measures (MMRM)||1.3|-2.0|0.6638
71859123|NCT03672175|143232413|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.89||0.1158|TWO_SIDED|95.0|-3.1|0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||||0.3|-3.1|0.1158
71859124|NCT03672175|143232414|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6905|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.2|-0.4|0.6905
71859125|NCT03672175|143232414|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.1082|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for the analysis. Treatment, BL CGI-S score, BL antidepressant use, assessment time point, and time point-by-treatment interaction were included in the model and were treated as fixed effects.|MMRM|||||0.1|-0.5|0.1082
71859126|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.65||0.5725|TWO_SIDED|95.0|-1.7|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||0.9|-1.7|0.5725
71859127|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.64||0.016|TWO_SIDED|95.0|-2.8|-0.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 3||-0.3|-2.8|0.0160
71859128|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.75||0.445|TWO_SIDED|95.0|-2.1|0.9||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||0.9|-2.1|0.4450
71859129|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0081|TWO_SIDED|95.0|-3.6|-0.5||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 8||-0.5|-3.6|0.0081
71859130|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8219|TWO_SIDED|95.0|-1.6|2.1||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||2.1|-1.6|0.8219
71859131|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.92||0.8166|TWO_SIDED|95.0|-2.0|1.6||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 42||1.6|-2.0|0.8166
71859132|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.11||0.9|TWO_SIDED|95.0|-2.3|2.0||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||2.0|-2.3|0.9000
71859133|NCT03672175|143232415|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.03||0.5004|TWO_SIDED|95.0|-2.7|1.3||MMRM was used for analysis with change from BL in HAM-D total score as dependent variable; treatment, BL HAM-D total score, antidepressant use, assessment time point, time point-by-treatment interaction as explanatory variables and fixed effects.|MMRM|||Day 182||1.3|-2.7|0.5004
71859134|NCT03672175|143232416|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8903|TWO_SIDED|95.0|0.65|1.63||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15: Generalized estimating equation (GEE)||1.63|0.65|0.8903
71859135|NCT03672175|143232416|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1207|TWO_SIDED|95.0|0.91|2.25||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.25|0.91|0.1207
71859136|NCT03672175|143232416|SUPERIORITY||Odds Ratio (OR)|1.07||||0.7897|TWO_SIDED|95.0|0.67|1.7||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.70|0.67|0.7897
71859137|NCT03672175|143232416|SUPERIORITY||Odds Ratio (OR)|1.1||||0.6837|TWO_SIDED|95.0|0.69|1.76||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.76|0.69|0.6837
71859138|NCT03672175|143232416|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6602|TWO_SIDED|95.0|0.51|1.53||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.53|0.51|0.6602
71859139|NCT03672175|143232416|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9268|TWO_SIDED|95.0|0.56|1.69||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||1.69|0.56|0.9268
71859140|NCT03672175|143232417|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8245|TWO_SIDED|95.0|0.62|1.83||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.83|0.62|0.8245
71859141|NCT03672175|143232417|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0756|TWO_SIDED|95.0|0.95|2.67||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||2.67|0.95|0.0756
71859142|NCT03672175|143232417|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5309|TWO_SIDED|95.0|0.7|2.01||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||2.01|0.70|0.5309
71859143|NCT03672175|143232417|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9085|TWO_SIDED|95.0|0.56|1.66||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 42||1.66|0.56|0.9085
71859144|NCT03672175|143232417|SUPERIORITY||Odds Ratio (OR)|1.34||||0.3476|TWO_SIDED|95.0|0.73|2.44||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.44|0.73|0.3476
71859145|NCT03672175|143232417|SUPERIORITY||Odds Ratio (OR)|1.45||||0.206|TWO_SIDED|95.0|0.82|2.57||GEE for binary response model, with factors for treatment, BL HAM-D total score, stratification factor (anti-depressant use at BL), assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 182||2.57|0.82|0.2060
71859146|NCT03672175|143232418|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8303|TWO_SIDED|95.0|0.67|1.65||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||1.65|0.67|0.8303
71859147|NCT03672175|143232418|SUPERIORITY||Odds Ratio (OR)|1.43||||0.1199|TWO_SIDED|95.0|0.91|2.24||GEE for binary response model, with factors for treatment, CGI-S BL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||||2.24|0.91|0.1199
71859148|NCT03672175|143232419|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.71||0.5021|TWO_SIDED|95.0|-1.9|0.9||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.9|-1.9|0.5021
71859149|NCT03672175|143232419|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.7||0.2868|TWO_SIDED|95.0|-2.1|0.6||MMRM with treatment, BL HAM-A total score, anti-depressant use at BL (Yes or No), assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.6|-2.1|0.2868
71859150|NCT03672175|143232420|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.35||0.5987|TWO_SIDED|95.0|-3.4|1.9||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||1.9|-3.4|0.5987
71921978|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-3.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-10.0|2.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||2.3|-10.0|
71921979|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-11.4|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||1.2|-11.4|
71859151|NCT03672175|143232420|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.36||0.1443|TWO_SIDED|95.0|-4.7|0.7||MMRM with treatment, BL MADRS total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||||0.7|-4.7|0.1443
71859152|NCT03672175|143232421|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.87||0.8499|TWO_SIDED|95.0|-3.3|4.0||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.0|-3.3|0.8499
71859153|NCT03672175|143232421|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.88||0.6265|TWO_SIDED|95.0|-4.6|2.8||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.8|-4.6|0.6265
71859154|NCT03672175|143232421|SUPERIORITY||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.97||0.7418|TWO_SIDED|95.0|-3.2|4.5||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.5|-3.2|0.7418
71859155|NCT03672175|143232421|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.94||0.7837|TWO_SIDED|95.0|-4.3|3.3||MMRM with treatment, BL HAM-D core subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.3|-4.3|0.7837
71859156|NCT03672175|143232422|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.74||0.6848|TWO_SIDED|95.0|-4.1|2.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.7|-4.1|0.6848
71859157|NCT03672175|143232422|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.72||0.11|TWO_SIDED|95.0|-6.1|0.6||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.6|-6.1|0.1100
71859158|NCT03672175|143232422|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.86||0.509|TWO_SIDED|95.0|-2.4|4.9||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.9|-2.4|0.5090
71859159|NCT03672175|143232422|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.77||0.8948|TWO_SIDED|95.0|-3.2|3.7||MMRM with treatment, BL HAM-D anxiety subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.7|-3.2|0.8948
71859160|NCT03672175|143232423|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.25||0.9591|TWO_SIDED|95.0|-4.5|4.3||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.3|-4.5|0.9591
71859161|NCT03672175|143232423|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|2.28||0.2713|TWO_SIDED|95.0|-7.0|2.0||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||2.0|-7.0|0.2713
71859162|NCT03672175|143232423|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|2.43||0.8048|TWO_SIDED|95.0|-4.2|5.4||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||5.4|-4.2|0.8048
71859163|NCT03672175|143232423|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|2.35||0.7665|TWO_SIDED|95.0|-5.3|3.9||MMRM with treatment, BL HAM-D Bech-6 subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||3.9|-5.3|0.7665
71859164|NCT03672175|143232424|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.91||0.8575|TWO_SIDED|95.0|-3.4|4.1||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||4.1|-3.4|0.8575
71859165|NCT03672175|143232424|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.94||0.1978|TWO_SIDED|95.0|-6.3|1.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||1.3|-6.3|0.1978
71859166|NCT03672175|143232424|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|2.08||0.9298|TWO_SIDED|95.0|-3.9|4.3||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||4.3|-3.9|0.9298
71859167|NCT03672175|143232424|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.03||0.5487|TWO_SIDED|95.0|-5.2|2.8||MMRM with treatment, BL HAM-D Maier subscale score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.8|-5.2|0.5487
71859168|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.14||0.627|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.3|-0.2|0.6270
71859169|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5463|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Depressed Mood||0.2|-0.4|0.5463
71859170|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.8716|TWO_SIDED|95.0|-0.3|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.3|-0.3|0.8716
71859171|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4383|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Depressed Mood||0.2|-0.4|0.4383
71681279|NCT00772005|142881189|SUPERIORITY_OR_OTHER|||||||0.0194||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0194
71859172|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4794|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.3|-0.1|0.4794
71859173|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9717|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Feelings of Guilt||0.2|-0.2|0.9717
71859174|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3701|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3701
71859175|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3972|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Feelings of Guilt||0.3|-0.1|0.3972
71859176|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.5761|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.5761
71859177|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.4379|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Suicide||0.1|-0.1|0.4379
71859178|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.6087|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.6087
71859179|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9791|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Suicide||0.1|-0.1|0.9791
71859180|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2093|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.2093
71859181|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5189|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early - Early Night||0.1|-0.3|0.5189
71859182|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6617|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.2|-0.2|0.6617
71859183|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.2632|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early - Early Night||0.3|-0.1|0.2632
71859184|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.274|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.1|-0.3|0.2740
71859185|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1185|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Middle - Middle Night||0.0|-0.3|0.1185
71859186|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.945|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.2|-0.2|0.9450
71859187|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6343|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Middle - Middle Night||0.1|-0.2|0.6343
71859188|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3169|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.1|-0.3|0.3169
71859189|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.09||0.0178|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insomnia Early Hours - Morning||0.0|-0.4|0.0178
71859190|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8504|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.2|-0.2|0.8504
71859191|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.5647|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insomnia Early Hours - Morning||0.1|-0.2|0.5647
71859192|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5914|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.3|0.5914
71859193|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4603|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Work and Activities||0.2|-0.4|0.4603
71859194|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5637|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.5637
71859195|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.4638|TWO_SIDED|95.0|-0.4|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Work and Activities||0.2|-0.4|0.4638
71859196|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1846|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|0.0|0.1846
71859197|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4837|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Retardation||0.2|-0.1|0.4837
71859198|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.1178|TWO_SIDED|95.0|0.0|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.2|0.0|0.1178
71859199|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7888|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Retardation||0.1|-0.1|0.7888
71859200|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9496|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.1|-0.1|0.9496
71859201|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0497|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Agitation||0.0|-0.3|0.0497
71859202|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4189|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.1|-0.2|0.4189
71859203|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1342|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Agitation||0.0|-0.3|0.1342
71859204|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9202|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.2|-0.3|0.9202
71859205|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.026|TWO_SIDED|95.0|-0.5|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Psychic||0.0|-0.5|0.0260
71859206|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.937|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.9370
71859207|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.844|TWO_SIDED|95.0|-0.3|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Psychic||0.2|-0.3|0.8440
71859208|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.09||0.448|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.3|-0.1|0.4480
71859209|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6345|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Anxiety Somatic||0.2|-0.1|0.6345
71859210|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4123|TWO_SIDED|95.0|-0.1|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.3|-0.1|0.4123
71859211|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.7523|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Anxiety Somatic||0.2|-0.2|0.7523
71859212|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6505|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6505
71859213|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3674|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Somatic Symptoms Gastrointestinal||0.1|-0.3|0.3674
71859214|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.836|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.2|-0.2|0.8360
71859215|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.687|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Somatic Symptoms Gastrointestinal||0.1|-0.2|0.6870
71859216|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1364|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1364
71859217|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1578|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: General Somatic Symptoms||0.0|-0.3|0.1578
71859218|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9062|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.9062
71859219|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.8596|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: General Somatic Symptoms||0.2|-0.2|0.8596
71859220|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9488|TWO_SIDED|95.0|-0.2|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.2|-0.2|0.9488
71859221|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.1514|TWO_SIDED|95.0|-0.3|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Genital Symptoms||0.0|-0.3|0.1514
71859222|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.5796|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.2|0.5796
71859223|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4739|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Genital Symptoms||0.1|-0.3|0.4739
71859224|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9439|TWO_SIDED|95.0|-0.1|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.1|0.9439
71859225|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.3891|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Hypochondriasis||0.1|-0.2|0.3891
71859226|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0308
71859227|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|0.0|0.3||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Hypochondriasis||0.3|0.0|0.0620
71859228|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.7744|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.1|-0.2|0.7744
71859229|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.9312|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Loss of Weight||0.2|-0.1|0.9312
71859230|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.3105|TWO_SIDED|95.0|-0.2|0.1||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.1|-0.2|0.3105
71859231|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.8406|TWO_SIDED|95.0|-0.1|0.2||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Loss of Weight||0.2|-0.1|0.8406
71859232|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.4834|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.4834
71859233|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.0961|TWO_SIDED|95.0|-0.1|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: Insight||0.0|-0.1|0.0961
71859234|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.829|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.8290
71859235|NCT03672175|143232425|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9546|TWO_SIDED|95.0|0.0|0.0||MMRM with treatment, each BL individual item HAM-D score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: Insight||0.0|0.0|0.9546
71859236|NCT03672175|143232426|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.78||0.1308|TWO_SIDED|95.0|-2.7|0.4||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.4|-2.7|0.1308
71859237|NCT03672175|143232426|SUPERIORITY||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.77||0.0096|TWO_SIDED|95.0|-3.5|-0.5||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||-0.5|-3.5|0.0096
71859238|NCT03672175|143232426|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.86||0.2674|TWO_SIDED|95.0|-0.7|2.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||2.7|-0.7|0.2674
71859239|NCT03672175|143232426|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.9771|TWO_SIDED|95.0|-1.7|1.7||MMRM with treatment, BL ISI total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42||1.7|-1.7|0.9771
71859240|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|4.42||0.611|TWO_SIDED|95.0|-10.9|6.4||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||6.4|-10.9|0.6110
71859241|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|4.19||0.0581|TWO_SIDED|95.0|-16.2|0.3||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sSL||0.3|-16.2|0.0581
71859242|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|5.68||0.4493|TWO_SIDED|95.0|-15.5|6.9||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||6.9|-15.5|0.4493
71859243|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|6.25||0.5587|TWO_SIDED|95.0|-16.0|8.6||MMRM with treatment, BL sSL score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sSL||8.6|-16.0|0.5587
71859244|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.06||0.5976|TWO_SIDED|95.0|-10.1|5.8||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||5.8|-10.1|0.5976
71859245|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|5.05||0.9421|TWO_SIDED|95.0|-9.6|10.3||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sWASO||10.3|-9.6|0.9421
71859246|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.86||0.5581|TWO_SIDED|95.0|-6.7|12.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||12.4|-6.7|0.5581
71859247|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|5.82||0.4997|TWO_SIDED|95.0|-7.5|15.4||MMRM with treatment, BL sWASO score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sWASO||15.4|-7.5|0.4997
71859248|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|24.0|STANDARD_ERROR_OF_MEAN|10.5||0.0224|TWO_SIDED|95.0|3.4|44.7||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||44.7|3.4|0.0224
71859249|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|17.4|STANDARD_ERROR_OF_MEAN|10.93||0.1117|TWO_SIDED|95.0|-4.1|38.9||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: sTST||38.9|-4.1|0.1117
71859250|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|14.1|STANDARD_ERROR_OF_MEAN|14.18||0.3208|TWO_SIDED|95.0|-13.8|42.0||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||42.0|-13.8|0.3208
71859251|NCT03672175|143232427|SUPERIORITY||LS Mean Difference|10.3|STANDARD_ERROR_OF_MEAN|13.4||0.444|TWO_SIDED|95.0|-16.1|36.6||MMRM with treatment, BL sTST score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28: sTST||36.6|-16.1|0.4440
71859252|NCT03672175|143232428|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4737|TWO_SIDED|95.0|-0.3|0.1||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.1|-0.3|0.4737
71859253|NCT03672175|143232428|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0138|TWO_SIDED|95.0|-0.4|0.0||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15||0.0|-0.4|0.0138
71859254|NCT03672175|143232428|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1098|TWO_SIDED|95.0|0.0|0.4||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.4|0.0|0.1098
71859255|NCT03672175|143232428|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6234|TWO_SIDED|95.0|-0.2|0.3||MMRM with treatment, BL sNAW score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 28||0.3|-0.2|0.6234
71859256|NCT03672175|143232429|SUPERIORITY||Odds Ratio (OR)|0.89||||0.6741|TWO_SIDED|95.0|0.52|1.53||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.53|0.52|0.6741
71906555|NCT00884221|143335422|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, ITT|2.2||||0.499|TWO_SIDED|95.0|-4.2|8.6||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin-recombinant FSH, ITT analysis set|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||8.6|-4.2|0.499
71906556|NCT00884221|143335423|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Estradiol||||<0.001
71906557|NCT00884221|143335424|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||FSH||||<0.001
71906558|NCT00884221|143335425|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Free Androgen Index||||<0.001
71906559|NCT00884221|143335426|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Luteinizing hormone||||<0.001
71906560|NCT00884221|143335427|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Progesterone||||0.630
71906561|NCT00884221|143335428|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, PP|3.0||||0.387|TWO_SIDED|95.0|-3.8|9.8||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin - recombinant FSH, PP|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR - π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR - π recombinant FSH \> -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."||9.8|-3.8|0.387
71906562|NCT00884221|143335429|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Prolactin||||0.047
71906563|NCT00884221|143335430|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Sex hormone binding globulin||||0.009
71906564|NCT00884221|143335431|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Testosterone||||<0.001
71906565|NCT00884221|143335432|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>= 12 mm on the last stimulation day||||0.025
71906566|NCT00884221|143335432|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 12-14 mm on the last stimulation day||||0.024
71906567|NCT00884221|143335432|SUPERIORITY_OR_OTHER|||||||0.728||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 15-16 mm on the last stimulation day||||0.728
71906568|NCT00884221|143335432|SUPERIORITY_OR_OTHER|||||||0.285||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles \>=17 mm on the last stimulation day||||0.285
71906569|NCT00884221|143335433|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who underwent the oocyte retrieval procedure were included in the analysis||Treatments were compared using the Wilcoxon test for the average number of oocytes retrieved.||||<0.001
71906570|NCT00884221|143335434|SUPERIORITY_OR_OTHER|||||||0.969||95.0|||||Wilcoxon (Mann-Whitney)|Only participants who had oocytes retrieved were included in the analysis.||||||0.969
71906571|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 1 / 2pn||||0.406
71906572|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.232||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 2 / 2pn||||0.232
71906573|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.412||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 3 / 2pn||||0.412
71906574|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.438||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 4 / 2pn||||0.438
71906575|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 5 / 2pn||||0.390
71906576|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.958||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 4AA / 2pn||||0.958
71906577|NCT00884221|143335435|SUPERIORITY_OR_OTHER|||||||0.954||95.0|||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 5AA / 2pn||||0.954
71859257|NCT03672175|143232429|SUPERIORITY||Odds Ratio (OR)|0.79||||0.3924|TWO_SIDED|95.0|0.46|1.36||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 15||1.36|0.46|0.3924
71859258|NCT03672175|143232429|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7307|TWO_SIDED|95.0|0.51|1.6||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.60|0.51|0.7307
71859259|NCT03672175|143232429|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8358|TWO_SIDED|95.0|0.52|1.7||GEE for binary response model, with factors for treatment, BL sleep quality response, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|GEE|||Day 28||1.70|0.52|0.8358
71859260|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.72||0.7375|TWO_SIDED|95.0|-1.6|1.2||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.2|-1.6|0.7375
71859261|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.74||0.5144|TWO_SIDED|95.0|-1.9|1.0||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: PCS Score||1.0|-1.9|0.5144
71859262|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.79||0.8343|TWO_SIDED|95.0|-1.7|1.4||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||1.4|-1.7|0.8343
71859263|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.85||0.4569|TWO_SIDED|95.0|-1.0|2.3||MMRM with treatment, BL SF-36v2 physical component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: PCS Score||2.3|-1.0|0.4569
71906578|NCT00884221|143335436|SUPERIORITY_OR_OTHER||Comparison of distributions|0.398||||0.398|TWO_SIDED|95.0|-3.6|9.1|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.1|-3.6|0.398
71921980|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-8.7|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-15.2|-2.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||-2.2|-15.2|
71921981|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-5.3|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-12.0|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||1.3|-12.0|
71681280|NCT00772005|142881189|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2270
71859264|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.63||0.4663|TWO_SIDED|95.0|-2.0|4.4||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||4.4|-2.0|0.4663
71859265|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.68||0.1138|TWO_SIDED|95.0|-0.6|6.0||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 15: MCS Score||6.0|-0.6|0.1138
71859266|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.74||0.7901|TWO_SIDED|95.0|-3.0|3.9||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||3.9|-3.0|0.7901
71859267|NCT03672175|143232430|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|1.71||0.3955|TWO_SIDED|95.0|-1.9|4.8||MMRM with treatment, BL SF-36v2 mental component score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction as fixed effects were used for analysis.|MMRM|||Day 42: MCS Score||4.8|-1.9|0.3955
71859268|NCT03672175|143232431|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.8821|TWO_SIDED|95.0|-1.8|1.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||1.5|-1.8|0.8821
71859269|NCT03672175|143232431|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.83||0.151|TWO_SIDED|95.0|-2.8|0.4||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 15||0.4|-2.8|0.1510
71859270|NCT03672175|143232431|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.84||0.2926|TWO_SIDED|95.0|-0.8|2.5||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||2.5|-0.8|0.2926
71859271|NCT03672175|143232431|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.83||0.4785|TWO_SIDED|95.0|-2.2|1.0||MMRM with treatment, BL PHQ-9 total score, anti-depressant use at BL, assessment time point, and time point-by-treatment interaction were used for analysis.|MMRM|||Day 42||1.0|-2.2|0.4785
71859272|NCT01898442|143232499|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||ANCOVA|||||||0.017
71859273|NCT05178979|143232505|SUPERIORITY||Wald Chi-Square|1.94||||0.38|TWO_SIDED|||||Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.38
71906579|NCT00884221|143335437|SUPERIORITY_OR_OTHER||Comparison of distributions|1.8||||0.686|TWO_SIDED|95.0|-5.6|9.2|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in cumulative live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set|||9.2|-5.6|0.686
71906580|NCT02757092|143335438|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906581|NCT02757092|143335439|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71859274|NCT05178979|143232505|SUPERIORITY||unstandardized beta|0.93|STANDARD_ERROR_OF_MEAN|4.63||0.84|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.84
71906582|NCT02757092|143335440|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906583|NCT02757092|143335441|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71859275|NCT05178979|143232505|SUPERIORITY||unstandardized beta|-2.62|STANDARD_ERROR_OF_MEAN|3.87||0.5|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, gender, lifetime experience of intimate partner violence (IPV) and are adjusted for multiple time points.||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.50
71859276|NCT05178979|143232506|SUPERIORITY||Wald Chi-square|2.0||||0.37|TWO_SIDED|||||Models control for clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.37
71859277|NCT05178979|143232506|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.18|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 6-month follow-up|Regression, Linear|Model controls for clinic||Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.18
71859278|NCT05178979|143232506|SUPERIORITY||unstandardized beta|-0.03|STANDARD_ERROR_OF_MEAN|0.02||0.19|TWO_SIDED|||||P-value is adjusted for clinic; this value is the 12-month follow-up|Regression, Linear|Model controls for clinic|Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.||||0.19
71906584|NCT02757092|143335442|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906585|NCT02757092|143335443|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71906586|NCT02757092|143335444|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71906587|NCT02757092|143335445|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906588|NCT02757092|143335446|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906589|NCT02757092|143335447|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906590|NCT02757092|143335448|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906591|NCT02757092|143335449|SUPERIORITY|||||||0.05|||||||Chi-squared|||Descriptive statistics were expressed as mean ± standard deviation or median and interquartile range depending on the nature and distribution of the variables||||0.05
71906592|NCT02757092|143335450|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71906593|NCT02757092|143335451|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906594|NCT02757092|143335452|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906595|NCT02757092|143335453|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71906596|NCT02757092|143335455|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906597|NCT02757092|143335456|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906598|NCT02757092|143335457|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906599|NCT02757092|143335458|SUPERIORITY||||||<|0.05|||||||Chi-squared|||null hypothesis||||<0.05
71906600|NCT02757092|143335459|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71859279|NCT05178979|143232507|SUPERIORITY||Wald Chi-square|10.84||||0.004|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
71859280|NCT05178979|143232507|SUPERIORITY||unstandardized beta|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||<0.001
71859281|NCT05178979|143232507|SUPERIORITY||unstandardized beta|-0.02|STANDARD_ERROR_OF_MEAN|0.09||0.86|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.86
71859282|NCT05178979|143232508|SUPERIORITY||Wald Chi-square|21.42|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Logistic||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71906601|NCT02757092|143335460|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71906602|NCT02757092|143335461|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906603|NCT02757092|143335462|SUPERIORITY||||||<|0.05|||||||ANOVA|||null hypothesis||||<0.05
71906604|NCT02757092|143335464|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906605|NCT02757092|143335465|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906606|NCT02757092|143335466|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71906607|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|0.99|
71859283|NCT05178979|143232508|SUPERIORITY||unstandardized beta|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||0.81
71859284|NCT05178979|143232508|SUPERIORITY||unstandardized beta|-0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||update||||<0.001
71859285|NCT05178979|143232509|SUPERIORITY||Wald Chi-square|150.43|||<|0.001|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71859286|NCT05178979|143232509|SUPERIORITY||unstandardized beta|0.17|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up|Regression, Linear|||||||0.002
71859287|NCT05178979|143232509|SUPERIORITY||unstandardized beta|0.13|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up|Regression, Linear|||||||0.03
71859288|NCT05178979|143232510|SUPERIORITY||Wald Chi-square|8.72||||0.01|TWO_SIDED|||||Models control for clinic, cadre, and gender and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
71859289|NCT05178979|143232510|SUPERIORITY||unstandardized beta|0.42|STANDARD_ERROR_OF_MEAN|0.29||0.15|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.15
71859290|NCT05178979|143232510|SUPERIORITY||unstandardized beta|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.008|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, cadre, and gender and are adjusted for multiple time points.||||||0.008
71859291|NCT05178979|143232511|SUPERIORITY||Wald Chi-square|172.52|||<|0.001|TWO_SIDED|||||Models control for clinic and income and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71906608|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||0.89|0.59|
71859292|NCT05178979|143232511|SUPERIORITY||unstandardized beta|0.14|STANDARD_ERROR_OF_MEAN|0.34||0.68|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||0.68
71859293|NCT05178979|143232511|SUPERIORITY||unstandardized beta|-0.83|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic and income and are adjusted for multiple time points.||||||<0.001
71859294|NCT05178979|143232512|SUPERIORITY|Models control for clinic, income, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|25.27|||<|0.001|TWO_SIDED||||||Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71859295|NCT05178979|143232512|SUPERIORITY||unstandardized beta|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.1|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 6-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points.||||||0.10
71859296|NCT05178979|143232512|SUPERIORITY||unstandardized beta|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.54|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is the 12-month follow-up.|Regression, Linear|Models control for clinic, income, years living with HIV and are adjusted for multiple time points||||||0.54
71859297|NCT05178979|143232513|SUPERIORITY|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Wald Chi-square|36.04|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71859298|NCT05178979|143232513|SUPERIORITY||unstandardized beta|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.97|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||0.97
71859299|NCT05178979|143232513|SUPERIORITY||unstandardized beta|-0.29|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, AUDIT score and are adjusted for multiple time points.||||||<0.001
71906609|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.44|1.96|
71859300|NCT05178979|143232514|SUPERIORITY||Wald Chi-square|9.46||||0.01|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.01
71859301|NCT05178979|143232514|SUPERIORITY||unstandardized beta|0.03|STANDARD_ERROR_OF_MEAN|0.12||0.81|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.81
71859302|NCT05178979|143232514|SUPERIORITY||unstandardized beta|-0.25|STANDARD_ERROR_OF_MEAN|0.13||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, AUDIT score and are adjusted for multiple time points.||||||0.04
71859303|NCT05178979|143232515|SUPERIORITY||Wald Chi-square|14.77|||<|0.001|TWO_SIDED|||||Models control for clinic, gender, years living with HIV and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||<0.001
71859304|NCT05178979|143232515|SUPERIORITY||unstandardized beta|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.45|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.45
71859305|NCT05178979|143232515|SUPERIORITY||unstandardized beta|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.02|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV and are adjusted for multiple time points.||||||0.02
71859306|NCT05178979|143232516|SUPERIORITY||Wald Chi-square|11.06||||0.004|TWO_SIDED|||||Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.004
71859307|NCT05178979|143232516|SUPERIORITY||unstandardized beta|-0.06|STANDARD_ERROR_OF_MEAN|0.06||0.35|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.35
71859308|NCT05178979|143232516|SUPERIORITY||unstandardized beta|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.04|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, AUDIT score, food insecurity and are adjusted for multiple time points.||||||0.04
71859309|NCT05178979|143232517|SUPERIORITY||Wald Chi-square|2.84||||0.24|TWO_SIDED|||||Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points. Models run using generalized estimating equations (GEE) to account for dependence in repeated, clustered data.|Regression, Linear||Wald Chi-Square tests the overall arm\*time intervention effect across the timepoints|||||0.24
71859310|NCT05178979|143232517|SUPERIORITY||unstandardized beta|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.92|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 6-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.92
71859311|NCT05178979|143232517|SUPERIORITY||unstandardized beta|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.21|TWO_SIDED|||||P-value is adjusted for multiple comparisons; this value is for the 12-month follow-up.|Regression, Linear|Models control for clinic, gender, years living with HIV, travel time to clinic and are adjusted for multiple time points.||||||0.21
71681281|NCT00772005|142881189|SUPERIORITY_OR_OTHER|||||||0.1181||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1181
71681282|NCT00772005|142881190|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
71681283|NCT00772005|142881190|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0419
71681284|NCT00772005|142881190|SUPERIORITY_OR_OTHER|||||||0.0146||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0146
71859312|NCT03124550|143232518|OTHER|||||||0.0008|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly average steps over the 6-week intervention.||||.0008
71859313|NCT03124550|143232519|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.01
71859314|NCT03124550|143232520|SUPERIORITY|||||||0.94|||||||t-test, 2 sided|||Pre-test and post-test comparison||||.94
71859315|NCT03124550|143232521|OTHER|||||||0.0007|||||||Multilevel Modeling|||Multilevel modeling with the LMER package in R was used to determine whether participants changed in weekly number of social contact over the 6-week intervention.||||.0007
71859316|NCT03311269|143232544|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.2|-2.3||This p-value corresponds to the change from Baseline to Week 12 for both treatment groups (ClariVein RES 1% Injection and ClariVein RES 3% Injection) combined.|t-test, 2 sided|One-Sample||Continuous variables summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum and maximum. Categorical variables summarized using frequencies and percentages. All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. For efficacy analyses, missing post-treatment data will be imputed using last observation carried forward (LOCF). Missing safety data will not be imputed.||-2.3|-6.2|<0.001
71906610|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.86|2.22|
71906611|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.75|1.10|
71906612|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.74|1.12|
71681285|NCT00772005|142881191|SUPERIORITY_OR_OTHER|||||||0.1292||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1292
71906613|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.24|1.59|
71906614|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.23|0.77|
71906615|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.86|1.61|
71906616|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.92|1.81|
71906617|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.79|1.42|
71906618|NCT01646398|143335470|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.49|1.84|
71681286|NCT00772005|142881191|SUPERIORITY_OR_OTHER|||||||0.3773||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3773
71906619|NCT01646398|143335471|SUPERIORITY_OR_OTHER||Difference in percentage|26.8|||||TWO_SIDED|95.0|19.3|34.0||||||Difference in proportions (13vPnC - 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.||34.0|19.3|
71859317|NCT03311269|143232544|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-3.4||||0.011|TWO_SIDED|95.0|-5.8|-1.0||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.0|-5.8|0.011
71859318|NCT03311269|143232544|OTHER|The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.|Mean Difference (Final Values)|-5.1||||0.01|TWO_SIDED|95.0|-8.7|-1.6||This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group.|t-test, 2 sided|One-Sample||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||-1.6|-8.7|0.010
71859319|NCT03311269|143232544|OTHER|An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate|Least-Squares Mean Difference|-1.2||||0.531|TWO_SIDED|95.0|-3.7|1.3||This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection).|ANCOVA|||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.||1.3|-3.7|0.531
71859320|NCT03311269|143232545|OTHER||Descriptive (Percentage)|94.4|||||TWO_SIDED|95.0|72.7|99.9|||||The count of the combined treatment group for the elimination of saphenous vein reflux at Week 12 posttreatment is 17/18 (94.4%).|The secondary efficacy endpoint, the elimination of saphenous vein reflux at Week 12 posttreatment, will be summarized for both treatments combined using the count and percentage, together with a 95% Wilson (score) confidence interval for the proportion.||99.9|72.7|
71859321|NCT03311269|143232545|OTHER||Percentage Difference|11.1||||1|TWO_SIDED|95.0|-20.5|42.8||All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.|Chi-squared|||For elimination of saphenous vein reflux at Week 12 posttreatment, the treatment difference for ClariVein RES 1% Injection versus ClariVein RES 3% Injection for the proportion was assessed by a chi-square test together with a 95% Wilson (score) confidence interval for the treatment difference.||42.8|-20.5|1.000
71859322|NCT01721746|143232563|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.68|1.08|||||From stratified cox proportional hazard model with treatment group as a single covariate, stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (IVRS source)|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.08|0.68|
71859323|NCT01721746|143232564|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.1|0.78|1.36|||||Stratified Cox proportional hazard model.|Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)||1.36|0.78|
71859324|NCT01721746|143232565|SUPERIORITY||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.44|3.16||||||For \<5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||3.16|0.44|
71859325|NCT01721746|143232565|SUPERIORITY||Odds Ratio (OR)|5.49|||||TWO_SIDED|95.0|1.92|19.08||||||For \>=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice||19.08|1.92|
71859326|NCT01721746|143232566|SUPERIORITY||Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.5|1.01|||||From unstratified Cox proportional hazard model|PD-L1 Positive||1.01|0.50|
71859327|NCT01721746|143232567|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.75|1.41|||||From unstratified Cox proportional hazard model|PD-L1 Negative||1.41|0.75|
71859328|NCT04358068|143232575|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.51||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.51
71859329|NCT04358068|143232576|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.79||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.79
71859330|NCT04358068|143232577|SUPERIORITY|Participant specific AUCs were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.53||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.53
71859331|NCT04358068|143232578|SUPERIORITY|Participant specific durations were compared between randomized arms using a two-sided Wilcoxon test with a two-sided 5% type I error rate||||||0.83||||||Wilcoxon Test was not stratified by high/low risk because of the small number enrolled|Wilcoxon (Mann-Whitney)|||||||0.83
71906620|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|1.3|||||TWO_SIDED|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|0.99|
71859332|NCT00239681|143232591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.46|0.69|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.69|0.46|<0.0001
71859333|NCT00239681|143232592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||<|0.021||95.0|0.67|0.97|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.97|0.67|<0.021
71859334|NCT00239681|143232593|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84|||<|0.172||95.0|0.65|1.08|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.08|0.65|<0.172
71859335|NCT00239681|143232594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27|||<|0.015||95.0|1.05|1.53|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.53|1.05|<0.015
71859336|NCT00239681|143232595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.018||95.0|0.35|0.91|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||0.91|0.35|0.018
71859337|NCT00239681|143232596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.548||95.0|0.88|1.28|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)|||1.28|0.88|0.548
71859338|NCT03599622|143232597|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|4.3||||0.5812|TWO_SIDED|95.0|-11.0|19.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.5|-11.0|0.5812
71681287|NCT00772005|142881191|SUPERIORITY_OR_OTHER|||||||0.1348||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1348
71859339|NCT03599622|143232597|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.2||||0.5812|TWO_SIDED|95.0|0.6|2.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.5|0.6|0.5812
71859340|NCT03599622|143232597|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-6.3||||0.372|TWO_SIDED|95.0|-20.2|7.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||7.6|-20.2|0.3720
71859341|NCT03599622|143232597|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.7||||0.372|TWO_SIDED|95.0|0.3|1.5||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.5|0.3|0.3720
71859342|NCT03599622|143232598|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|15.0||||0.0198|TWO_SIDED|95.0|3.7|26.3||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||26.3|3.7|0.0198
71859343|NCT03599622|143232598|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|3.4||||0.0198|TWO_SIDED|95.0|1.2|9.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.8|1.2|0.0198
71859344|NCT03599622|143232598|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.2||||0.1584|TWO_SIDED|95.0|-2.6|19.0||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||19.0|-2.6|0.1584
71859345|NCT03599622|143232598|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|2.1||||0.1584|TWO_SIDED|95.0|0.7|6.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||6.1|0.7|0.1584
71859346|NCT03599622|143232599|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|7.7||||0.3464|TWO_SIDED|95.0|-8.2|23.6||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||23.6|-8.2|0.3464
71859347|NCT03599622|143232599|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.4||||0.3464|TWO_SIDED|95.0|0.7|2.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||2.8|0.7|0.3464
71859348|NCT03599622|143232599|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-1.2||||0.8857|TWO_SIDED|95.0|-17.0|14.7||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||14.7|-17.0|0.8857
71859349|NCT03599622|143232599|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.0||||0.8857|TWO_SIDED|95.0|0.5|1.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.9|0.5|0.8857
71859350|NCT03599622|143232600|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|8.1||||0.2841|TWO_SIDED|95.0|-6.7|22.9||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||22.9|-6.7|0.2841
71859351|NCT03599622|143232600|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|1.5||||0.2841|TWO_SIDED|95.0|0.7|3.1||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||3.1|0.7|0.2841
71859352|NCT03599622|143232600|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Risk Difference (RD)|-4.2||||0.5417|TWO_SIDED|95.0|-17.6|9.2||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||9.2|-17.6|0.5417
71859353|NCT03599622|143232600|SUPERIORITY|Cochran-Mantel-Haenszel stratified by geographic region (US, Japan, Rest of World), prior exposure to tumor necrosis factor inhibitor (TNFi; Exposed/Naive), and concomitant corticosteroid use (Yes/No).|Odds Ratio (OR)|0.8||||0.5417|TWO_SIDED|95.0|0.3|1.8||Based on a 2-sided test at a significance level of 0.025.|Mantel Haenszel||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||1.8|0.3|0.5417
71859354|NCT03599622|143232601|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|95.0|-4.3|-1.8|||ANCOVA|||||-1.8|-4.3|
71859355|NCT03599622|143232601|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.92||0.0428|TWO_SIDED|95.0|-3.7|-0.1||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||3 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.1|-3.7|0.0428
71681288|NCT00772005|142881192|SUPERIORITY_OR_OTHER|||||||0.9642||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9642
71859356|NCT03599622|143232601|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|95.0|-4.8|-2.0|||ANCOVA|||||-2.0|-4.8|
71859357|NCT03599622|143232601|SUPERIORITY|Adjusted means, 95% confidence intervals, and p-values are from an analysis of covariance model with factors for geographic region, prior exposure to tumor necrosis factor inhibitor, and concomitant corticosteroid use, and the baseline value as a covariate.|Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.95||0.0177|TWO_SIDED|95.0|-4.1|-0.4||Based on a 2-sided test at a significance level of 0.025.|ANCOVA||6 mg BMS-986165 (numerator) vs Placebo (denominator)|||-0.4|-4.1|0.0177
71859358|NCT03599622|143232601|EQUIVALENCE|Mean Change From Baseline|Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|95.0|-2.6|0.3||||||||0.3|-2.6|
71859359|NCT03599622|143232601|EQUIVALENCE|Mean Change from Baseline|Mean Difference (Final Values)|-6.0|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|95.0|-9.7|-2.3|||ANCOVA|||||-2.3|-9.7|
71859360|NCT02143063|143232632|SUPERIORITY||comparison of rank sum|3752.0||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.01
71859361|NCT02143063|143232632|SUPERIORITY||comparison of rank sum|5287.5||||0.78|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.78
71859362|NCT02143063|143232633|SUPERIORITY||comparison of rank sum|3675.5||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Primary Aim 1: Compare the standard care and standard care plus traditional CM conditions||||.02
71859363|NCT02143063|143232633|SUPERIORITY||comparison of rank sum|5189.5||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.61
71859364|NCT00623363|143232634|SUPERIORITY|||||||0.503|||||||Monte Carlo estimates|||Baseline (Day -7)||||0.503
71859365|NCT00623363|143232634|SUPERIORITY||Least Squares (LS) Mean|20.6|||||TWO_SIDED|95.0|1.82|39.37||||||Average of Days 1 and 2||39.37|1.82|
71859366|NCT00623363|143232634|SUPERIORITY||Least Squares (LS) Mean|3.6|||||TWO_SIDED|95.0|-15.18|22.37||||||Change from Baseline||22.37|-15.18|
71859367|NCT00623363|143232634|SUPERIORITY||Least Squares (LS) Mean|36.59|||||TWO_SIDED|95.0|24.04|49.14||||||Average of Days 1 and 2||49.14|24.04|
71859368|NCT00623363|143232634|SUPERIORITY||Least Squares (LS) Mean|19.59||||0.16|TWO_SIDED|95.0|7.04|32.14|||ANCOVA|||Change from Baseline||32.14|7.04|0.160
71859369|NCT01130168|143232653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|||<|0.0005|TWO_SIDED|95.0|-15.3|-10.9|||ANOVA|||||-10.9|-15.3|<0.0005
71859370|NCT01130168|143232653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.016|TWO_SIDED|95.0|-4.9|-0.6|||ANOVA|||||-0.6|-4.9|0.016
71859371|NCT01130168|143232654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.407|TWO_SIDED|95.0|-1.7|4.3|||ANOVA|||||4.3|-1.7|0.407
71859372|NCT01130168|143232654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.0005|TWO_SIDED|95.0|-8.9|-2.9|||ANOVA|||||-2.9|-8.9|<0.0005
71859373|NCT01130168|143232655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|||<|0.0005|TWO_SIDED|95.0|-21.2|-10.1|||ANOVA|||||-10.1|-21.2|<0.0005
71859374|NCT01130168|143232655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3||||0.001|TWO_SIDED|95.0|-17.4|-6.3|||ANOVA|||||-6.3|-17.4|0.001
71859375|NCT01130168|143232656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8||||0.186|TWO_SIDED|95.0|-9.5|1.8|||ANOVA|||||1.8|-9.5|0.186
71859376|NCT01130168|143232656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.1|||<|0.0005|TWO_SIDED|95.0|-21.7|-10.5|||ANOVA|||||-10.5|-21.7|<0.0005
71859377|NCT01130168|143232657|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.2|||<|0.0005|TWO_SIDED|95.0|-12.1|-6.4|||ANOVA|||||-6.4|-12.1|<0.0005
71859378|NCT01130168|143232657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.035|TWO_SIDED|95.0|-6.0|-0.3|||ANOVA|||||-0.3|-6.0|0.035
71859379|NCT01130168|143232658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8||||0.428|TWO_SIDED|95.0|-6.1|2.6|||ANOVA|||||2.6|-6.1|0.428
71859380|NCT01130168|143232658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.8|||<|0.0005|TWO_SIDED|95.0|-13.1|-4.5|||ANOVA|||||-4.5|-13.1|<0.0005
71859381|NCT01130168|143232659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.0005|TWO_SIDED|95.0|-17.5|-10.0|||ANOVA|||||-10.0|-17.5|<0.0005
71859382|NCT01130168|143232659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.015|TWO_SIDED|95.0|-8.5|-1.0|||ANOVA|||||-1.0|-8.5|0.015
71859383|NCT01130168|143232660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.112|TWO_SIDED|95.0|-9.9|1.0|||ANOVA|||||1.0|-9.9|0.112
71859384|NCT01130168|143232660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|||<|0.0005|TWO_SIDED|95.0|-20.7|-9.8|||ANOVA|||||-9.8|-20.7|<0.0005
71859385|NCT01130168|143232661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|||<|0.0005|TWO_SIDED|95.0|-11.8|-6.2|||ANOVA|||||-6.2|-11.8|<0.0005
71859386|NCT01130168|143232661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0||||0.039|TWO_SIDED|95.0|-5.8|-0.2|||ANOVA|||||-0.2|-5.8|0.039
71859387|NCT01130168|143232662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.267|TWO_SIDED|95.0|-6.6|1.8|||ANOVA|||||1.8|-6.6|0.267
71859388|NCT01130168|143232662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0005|TWO_SIDED|95.0|-12.7|-4.3|||ANOVA|||||-4.3|-12.7|<0.0005
71859389|NCT01702519|143232663|NON_INFERIORITY_OR_EQUIVALENCE|Bio-equivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25|Treatment Ratio|0.946|||||TWO_SIDED|90.0|0.912|0.982|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the two treatments.||0.982|0.912|
71859390|NCT01702519|143232664|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25.|Treatment Ratio|0.962|||||TWO_SIDED|90.0|0.92|1.0|||Treatment Ratio||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the treatments.||1.00|0.92|
71859391|NCT01795859|143232669|SUPERIORITY_OR_OTHER||LSMean Difference|-2.49|||<|0.0001|TWO_SIDED|95.0|-3.69|-1.29|||ANCOVA|||||-1.29|-3.69|<0.0001
71859392|NCT01795859|143232670|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.002|TWO_SIDED|95.0|12.4|49.8|||Difference of proportions|||||49.8|12.4|0.0020
71859393|NCT01795859|143232671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.9||||0.0022|TWO_SIDED|95.0|11.4|46.4|||Difference of proportions|||||46.4|11.4|0.0022
71859394|NCT01795859|143232672|SUPERIORITY_OR_OTHER||LSMean Difference|4.34||||0.0308|TWO_SIDED|95.0|0.41|8.27|||Mixed Models Analysis|||||8.27|0.41|0.0308
71859395|NCT01795859|143232673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.1415|TWO_SIDED|95.0|-0.3|2.3|||Mixed Models Analysis|||||2.3|-0.3|0.1415
71859396|NCT03738397|143232674|SUPERIORITY||Adjusted Response Rate Difference|9.7||||0.007|TWO_SIDED|95.0|2.6|16.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||16.7|2.6|0.007
71859397|NCT03738397|143232675|SUPERIORITY||Least Squares (LS) Mean Difference|-18.21|STANDARD_ERROR_OF_MEAN|2.753|<|0.001|TWO_SIDED|95.0|-23.61|-12.8||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-12.80|-23.61|<0.001
71859398|NCT03738397|143232676|SUPERIORITY||Adjusted Response Rate Difference|20.4|||<|0.001|TWO_SIDED|95.0|14.8|26.0||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||26.0|14.8|<0.001
71859399|NCT03738397|143232677|SUPERIORITY||Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|13.8|28.6||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||28.6|13.8|<0.001
71859400|NCT03738397|143232678|SUPERIORITY||LS Mean Difference|-28.02|STANDARD_ERROR_OF_MEAN|3.177|<|0.001|TWO_SIDED|95.0|-34.25|-21.78||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-21.78|-34.25|<0.001
71859401|NCT03738397|143232679|SUPERIORITY||Adjusted Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.3|32.7||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||32.7|19.3|<0.001
71859402|NCT03738397|143232680|SUPERIORITY||LS Mean Difference|-23.02|STANDARD_ERROR_OF_MEAN|2.548|<|0.001|TWO_SIDED|95.0|-28.03|-18.02||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD categories in the model.|Difference = Upadacitinib - Dupilumab|||-18.02|-28.03|<0.001
71859403|NCT03738397|143232681|SUPERIORITY||Adjusted Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.4|27.3||A multiple testing procedure was used to provide a strong control of the type I error rate at alpha = 0.05 (2-sided) across analyses comparing upadacitinib versus dupilumab with respect to the primary and ranked secondary endpoints.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for vIGA-AD categories (moderate \[3\] versus severe \[4\]).|Response rate difference = Upadacitinib - Dupilumab|||27.3|12.4|<0.001
71859404|NCT03448536|143232708|SUPERIORITY||LS Means Difference|4.31|||<|0.001|TWO_SIDED|95.0|2.06|6.56|||ANCOVA|||||6.56|2.06|< 0.001
71859405|NCT03448536|143232709|SUPERIORITY||LS Means Difference|9.8|||<|0.001|TWO_SIDED|95.0|5.75|13.85|||ANCOVA|||||13.85|5.75|< 0.001
71859406|NCT03448536|143232710|SUPERIORITY||LS Means Difference|1.52|||=|0.129|TWO_SIDED|95.0|-0.45|3.49|||ANCOVA|||||3.49|-0.45|= 0.129
71859407|NCT03448536|143232711|SUPERIORITY||LS Means Difference|8.27|||<|0.001|TWO_SIDED|95.0|5.76|10.78|||ANCOVA|||||10.78|5.76|< 0.001
71859408|NCT03448536|143232712|SUPERIORITY||LS Means Difference|0.56|||=|0.307|TWO_SIDED|95.0|-0.52|1.64|||ANCOVA|||||1.64|-0.52|= 0.307
71859409|NCT03448536|143232713|SUPERIORITY||LS Means Difference|3.75|||<|0.001|TWO_SIDED|95.0|2.34|5.16|||ANCOVA|||||5.16|2.34|< 0.001
71859410|NCT03448536|143232714|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||< 0.001
71859411|NCT03448536|143232716|SUPERIORITY||||||=|0.002|||||||Cochran-Mantel-Haenszel|||||||= 0.002
71859412|NCT03783546|143232718|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71859413|NCT03783546|143232720|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71859414|NCT00097669|143232723|SUPERIORITY|"We used Kaplan-Meier methods to construct cumulative time-to-event curves for the two groups, with a comparison by use of the log-rank test.~We used a Cox proportional hazard model analysis to control for any potential imbalance in baseline characteristics and follow-up between the two groups."|Risk Ratio (RR)|0.91||||0.05|TWO_SIDED|95.0|0.82|1.0|||Log Rank|||||1.00|0.82|0.05
71859415|NCT00097669|143232723|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.81|1.0|||Regression, Cox|Analysis before adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.00|0.81|<0.05
71859416|NCT00097669|143232723|SUPERIORITY||Hazard Ratio (HR)|0.91|||<|0.05|TWO_SIDED|95.0|0.81|1.03|||Regression, Cox|Analysis after adjusting for any potential imbalance in the baseline characteristics and follow-up duration between the groups.||||1.03|0.81|<0.05
71859417|NCT00497874|143232728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.003||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(145) = 2.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.003
71859418|NCT00497874|143232729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.002||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(181) = 2.9||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.002
71859419|NCT00497874|143232730|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.04||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(153) = 1.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.04
71859420|NCT00497874|143232731|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.07||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(57) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.07
71859421|NCT00497874|143232732|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.05||95.0|||||t-test, 1 sided|t(94) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, logistic regression-and the results pooled.||||.05
71859422|NCT00497874|143232733|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.13||95.0||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(123) = 1.2||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology-in this case, the t-test-and the results pooled.||||.13
71859423|NCT02330276|143232734|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
71859424|NCT02330276|143232735|OTHER|one way ANOVA between groups|Mean Difference (Final Values)|77.9|STANDARD_DEVIATION|11.9|<|0.05|TWO_SIDED|95.0|70.3|85.5||for change in heart rate at 24 hr post-dosing from baseline between the 3 doses|ANOVA|||Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.||85.5|70.3|<0.05
71859425|NCT02330276|143232736|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
71859426|NCT02330276|143232737|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
71859427|NCT02330276|143232738|SUPERIORITY_OR_OTHER|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models|||||||0.05
71859428|NCT00004146|143232783|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.1|TWO_SIDED|95.0|0.65|1.12|||t-test, 1 sided|||the study design is to detect 30% reduction in hazard of deaths with 78% power at one side alpha level of 0.10. Overall survial time was calculated from time of histological diagnosis until time of death from any event.||1.12|0.65|0.10
71859429|NCT02808975|143232786|SUPERIORITY||||||=|0.049|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.049
71859430|NCT02808975|143232787|SUPERIORITY||||||=|0.067|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.067
71859431|NCT02808975|143232788|SUPERIORITY||||||=|0.003|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.003
71859432|NCT02808975|143232789|SUPERIORITY||||||=|0.313|||||||ANCOVA|Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.||||||=0.313
71859433|NCT02808975|143232790|SUPERIORITY||||||=|0.746|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.||||||=0.746
71859434|NCT03568812|143232827|SUPERIORITY||Mean Difference (Net)|111.8||||0.02|TWO_SIDED|95.0|40.9|182.7||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted CD4 level||182.7|40.9|0.02
71859435|NCT03568812|143232827|SUPERIORITY||Mean Difference (Net)|73.4||||0.03|TWO_SIDED|95.0|5.9|140.8||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted CD4 level||140.8|5.9|0.03
71859436|NCT03568812|143232828|SUPERIORITY||Mean Difference (Net)|0.3||||0.55|TWO_SIDED|95.0|-0.5|1.0||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of unadjusted Th17 change after intervention||1.0|-0.5|0.55
71859437|NCT03568812|143232828|SUPERIORITY||Mean Difference (Net)|0.1||||0.79|TWO_SIDED|95.0|-0.7|0.9||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||There is no difference between probiotics - placebo|The statistical analysis of adjusted Th17 change after intervention||0.9|-0.7|0.79
71859438|NCT03568812|143232830|SUPERIORITY||Mean Difference (Net)|-12.7||||0.03|TWO_SIDED|95.0|-23.9|-1.5||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of unadjusted Fecal Calprotectin Level change after intervention||-1.5|-23.9|0.03
71859439|NCT03568812|143232830|SUPERIORITY||Mean Difference (Net)|-15.6||||0.01|TWO_SIDED|95.0|-27.6|-3.6||The threshold for statistical significance was p = 0.05 The variable was adjusted to duration of ARV regimen and baseline CD4 level|ANCOVA||Treatment difference = Probiotics - Placebo|The statistical analysis of adjusted Fecal Calprotectin Level change after intervention||-3.6|-27.6|0.01
71859440|NCT03568812|143232832|SUPERIORITY|||||||0.551||||||The threshold for statistical significance was p = 0.05|Chi-squared|||The statistical analysis of food frequency change after intervention (12 weeks)||||0.551
71859441|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.9|5.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.6|-3.9|
71859442|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|3.3||||||95.0|-7.3|13.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||13.8|-7.3|
71859443|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|2.3||||||95.0|-2.1|7.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.3|-2.1|
71859444|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|-1.6||||||95.0|-8.2|4.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.7|-8.2|
71859445|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|-2.8|9.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-2.8|
71859446|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|0.7||||||95.0|-3.5|5.1||||||For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||5.1|-3.5|
71859447|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|1.1||||||95.0|-8.4|10.6||||||For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||10.6|-8.4|
71859448|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-4.8|9.2||||||For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.2|-4.8|
71859449|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|-1.7||||||95.0|-7.9|4.2||||||For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||4.2|-7.9|
71859450|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|2.1||||||95.0|-5.6|9.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||9.9|-5.6|
71859451|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-9.9|7.6||||||For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||7.6|-9.9|
71859452|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.0|2.8||||||For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||2.8|-3.0|
71859453|NCT00464945|143232851|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.6|3.5||||||For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated||3.5|-3.6|
71859454|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|1.35||||||95.0|1.1|1.65||||||For serotype 4 the GMC ratio was calculated||1.65|1.10|
71681289|NCT00772005|142881192|SUPERIORITY_OR_OTHER|||||||0.7814||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7814
71859455|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.7|1.31||||||For serotype 6B the GMC ratio was calculated||1.31|0.70|
71859456|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|1.05||||||95.0|0.89|1.24||||||For serotype 9V the GMC ratio was calculated||1.24|0.89|
71859457|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.71|1.22||||||For serotype 14 the GMC ratio was calculated||1.22|0.71|
71681290|NCT00772005|142881192|SUPERIORITY_OR_OTHER|||||||0.1455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1455
71859458|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|1.06||||||95.0|0.86|1.3||||||For serotype 18C the GMC ratio was calculated||1.30|0.86|
71859459|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.98||||||95.0|0.81|1.17||||||For serotype 19F the GMC ratio was calculated||1.17|0.81|
71859460|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.9||||||95.0|0.7|1.15||||||For serotype 23F the GMC ratio was calculated||1.15|0.70|
71859461|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|1.1||||||95.0|0.88|1.37||||||For serotype 1 the GMC ratio was calculated||1.37|0.88|
71859462|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|1.0||||||95.0|0.83|1.2||||||For serotype 3 the GMC ratio was calculated||1.20|0.83|
71859463|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.16||||||For serotype 5 the GMC ratio was calculated||1.16|0.79|
71859464|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.66|1.05||||||For serotype 6A the GMC ratio was calculated||1.05|0.66|
71859465|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.79|1.11||||||For serotype 7F the GMC ratio was calculated||1.11|0.79|
71859466|NCT00464945|143232855|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.79|1.13||||||For serotype 19A the GMC ratio was calculated||1.13|0.79|
71921982|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.4|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-7.6|2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||2.8|-7.6|
71921983|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-9.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||0.8|-9.7|
71921984|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.7|0.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||0.8|-10.7|
71921985|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-4.6|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-10.4|1.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||1.3|-10.4|
71921986|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-9.0|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.6|-3.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-3.4|-14.6|
71921987|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-8.5|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-14.2|-2.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||-2.8|-14.2|
71921988|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-13.8|1.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.5|-13.8|
71921989|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-6.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-14.3|1.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||1.2|-14.3|
71921990|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-8.0|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-15.0|-1.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||-1.0|-15.0|
71921991|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-7.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-14.2|0.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||0|-14.2|
71921992|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-1.7|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|-9.8|6.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||6.4|-9.8|
71921993|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-8.0|8.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||8.5|-8.0|
71921994|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-2.6|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.0|3.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||3.7|-9.0|
71921995|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-7.1|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||5.8|-7.1|
71859467|NCT01777126|143232889|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.0|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.||||<0.001
71859468|NCT01777126|143232892|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.0|||<|0.01|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were \< 0.05.||||<0.01
71906621|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||0.89|0.59|
71906622|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.6|||||TWO_SIDED|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.44|1.96|
71906623|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.86|2.22|
71906624|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.75|1.10|
71906625|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|1.4|||||TWO_SIDED|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.74|1.12|
71906626|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.24|1.59|
71906627|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||1.23|0.77|
71906628|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.1|||||TWO_SIDED|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.86|1.61|
71906629|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.3|||||TWO_SIDED|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.92|1.81|
71906630|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.0|||||TWO_SIDED|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||2.79|1.42|
71906631|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|2.5|||||TWO_SIDED|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.||3.49|1.84|
71906632|NCT01646398|143335472|SUPERIORITY_OR_OTHER||GMT Ratio|3.1|||||TWO_SIDED|95.0|2.38|4.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.||4.14|2.38|
71906633|NCT01517412|143335497|NON_INFERIORITY_OR_EQUIVALENCE|A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.|Least square (LS) mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.079|||TWO_SIDED|95.0|-0.067|0.242|||||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.||0.242|-0.067|
71906634|NCT01517412|143335497|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.079||0.2664|TWO_SIDED|||||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.||||0.2664
71906635|NCT01956240|143335511|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.51|STANDARD_DEVIATION|1.9|<|0.05|TWO_SIDED|95.0|||||ANOVA|A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.||||||<0.05
71906636|NCT01956240|143335512|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.0|||>|0.05|TWO_SIDED|95.0|||||ANOVA|Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.||||||>0.05
71906637|NCT00600028|143335516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||0.001
71906638|NCT00600028|143335517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0||||0.0001|TWO_SIDED|95.0|||||Mixed Models Analysis||The values represents three months on each intervention|||||.0001
71906639|NCT02928380|143335551|OTHER||Least square (LS) mean difference|-0.02||||0.0987|TWO_SIDED|95.0|-0.05|0.0|||ANOVA|ANOVA Model with weight of the peanut particle (food occlusion) as response variable, treatment and period as fixed effect.|Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.|H0: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is no different from using no adhesive H01: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is different from using no adhesive.||0.00|-0.05|0.0987
71906640|NCT03115112|143335557|NON_INFERIORITY|The non-inferiority margin of 0.35% was determined based on a reference clinical trial that demonstrated the effectiveness of sitagliptin, 100 mg, compared to placebo on HbA1c reduction in subjects with type 2 DM. A margin of 0.35% was selected to be approximately half of sitagliptin effect and remained clinically meaningful.|Difference of LS Means|0.08|||||TWO_SIDED|95.0|-0.07|0.22|||||Mixed-effects repeated measures analysis includes region, treatment, visit, treatment-by-visit interaction and the baseline HbA1c value as fixed effect covariates.|||0.22|-0.07|
71681291|NCT00772005|142881193|SUPERIORITY_OR_OTHER|||||||0.5722||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5722
71906641|NCT03115112|143335558|SUPERIORITY||Difference of LS Means|-0.37||||0.0123|TWO_SIDED|95.0|-0.7|-0.05|||Mixed-effects repeated measures|Covariate includes region, treatment, visit, treatment-by-visit interaction and the baseline FPG value as a fixed effect covariate.||||-0.05|-0.70|0.0123
71906642|NCT03115112|143335559|SUPERIORITY||Difference of LS Means|-2.54|||<|0.0001|TWO_SIDED|95.0|-3.15|-1.92|||Mixed-effects repeated measures|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.||||-1.92|-3.15|<0.0001
71906643|NCT03115112|143335560|SUPERIORITY||mixed-effects repeated measures|-2.33||||0.0276|TWO_SIDED|95.0|-4.7|0.05|||t-test, 1 sided|p value was presented based on one sided statistical tests using a 0.025 level of significance|Included region, treatment, visit, treatment-by-visit interaction and the baseline body weight value as fixed effect covariate.|||0.05|-4.70|0.0276
71906644|NCT01709786|143335625|SUPERIORITY_OR_OTHER||Bland-Altman Analysis|1.49|||||TWO_SIDED|||||p-value is not reported since Bland-Altman is not a hypothesis testing framework.|Limits of agreement||Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
71906645|NCT01709786|143335626|SUPERIORITY_OR_OTHER||Limits of agreement|-0.63|||||TWO_SIDED|||||p-value not reported since Bland-Altman is not a hypothesis testing framework.|Bland-Altman Analysis||Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.|||||
71906646|NCT00664755|143335629|SUPERIORITY||Odds Ratio (OR)|2.77||||0.011|TWO_SIDED|95.0|1.17|6.59|||Regression, Logistic|||||6.59|1.17|0.011
71906647|NCT01840228|143335639|SUPERIORITY||Risk Ratio (RR)|1.1||||0.74|TWO_SIDED|95.0|0.63|1.91|||Chi-squared|||||1.91|0.63|0.74
71906648|NCT01840228|143335640|SUPERIORITY||Risk Ratio (RR)|0.43||||0.13|TWO_SIDED|95.0|0.14|1.36|||Fisher Exact|||||1.36|0.14|0.13
71906649|NCT01840228|143335641|SUPERIORITY||Risk Ratio (RR)|1.5||||0.71|TWO_SIDED|95.0|0.51|4.43|||Fisher Exact|||||4.43|0.51|0.71
71906650|NCT01840228|143335642|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71681292|NCT00772005|142881193|SUPERIORITY_OR_OTHER|||||||0.1352||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1352
71859469|NCT01777126|143232893|SUPERIORITY_OR_OTHER||proportion|||||0.487||95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher's Exact Test. Results were considered statistically significant if p-values were \< 0.05.||||0.487
71859470|NCT01777126|143232894|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.302
71859471|NCT01777126|143232895|SUPERIORITY_OR_OTHER||Proportion|||||0.117|TWO_SIDED|95.0|||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher's Exact Test. The result was considered statistically significant if p-values were \< 0.05.||||0.117
71859472|NCT01777126|143232896|SUPERIORITY_OR_OTHER||Proportion|||||0.049||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.049
71859473|NCT01777126|143232897|SUPERIORITY_OR_OTHER||proportion|||||0.698||95.0|||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were \< 0.05.||||0.698
71859474|NCT02312206|143233001|SUPERIORITY||Hazard Ratio (HR)|0.826||||0.3028|TWO_SIDED|95.0|0.5735|1.1889|||Log Rank|||||1.1889|0.5735|0.3028
71859475|NCT04974723|143233017|NON_INFERIORITY|Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.1||||||||1.10|0.81|
71859476|NCT04974723|143233018|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.89|1.3||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.30|0.89|
71859477|NCT04974723|143233019|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.95|1.22||||||Cox proportional hazard model was used to calculate the hazard ratio with teriparatide as reference. Noninferiority of abaloparatide to teriparatide was to be concluded if the upper bound of the 2-sided 95% CI of the HR between abaloparatide versus teriparatide was \<1.3.||1.22|0.95|
71859478|NCT01086384|143233021|SUPERIORITY_OR_OTHER||Regression Cox|0.795|||||TWO_SIDED|95.0|0.642|0.985|||||The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|||0.985|0.642|
71859479|NCT01086384|143233021|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|15.9||||0.036|TWO_SIDED|95.0|13.5|18.2||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||18.2|13.5|0.036
71859480|NCT01086384|143233021|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|12.8||||0.036|TWO_SIDED|95.0|10.7|14.9||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.|||14.9|10.7|0.036
71859481|NCT01196819|143233024|NON_INFERIORITY|Non-inferiority margin is 0.13mm, if the two-sided upper 95% confidence bound is \<Δ, the Firehawk Stent being tested will be considered non-inferior to the control. This corresponds to a P value \<0.05 from a two-sided Student t-test comparing the difference between FirehawkStent and Xience stent to delta.|Mean Difference (Final Values)|0.17||||0.94|TWO_SIDED|95.0|0.0|0.29|||ANCOVA|||H0: Pe - Pc≥ ∆, H1: Pe - Pc \< ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .||0.29|0|0.94
71859482|NCT01196819|143233025|NON_INFERIORITY|Assume the in-stent percent diameter stenosis of both FIREHAWK and XIENCE V are 16 ± 16%, the non-inferiority value is 5%, the level of statistical significance is 0.05 (bilateral test), the power is 85%.||||||0.69|||||||Mixed Models Analysis|||||||0.69
71859483|NCT01196819|143233026|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71859484|NCT01196819|143233027|OTHER|||||||0.76|||||||Fisher Exact|||||||0.76
71859485|NCT01196819|143233028|OTHER|||||||0.77|||||||Fisher Exact|||||||0.77
71859486|NCT01196819|143233029|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71859487|NCT00992992|143233032|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|56.0|||||TWO_SIDED|95.0|37.0|75.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response (CR).|||75|37|
71859488|NCT00992992|143233032|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|19.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response unconfirmed (CRu).|||19|0|
71859489|NCT00992992|143233032|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants|20.0|||||TWO_SIDED|95.0|4.0|36.0|||||The estimated value reflects the percentage of participants with unconfirmed partial response.|||36|4|
71859490|NCT02250534|143233049|SUPERIORITY||Mean Difference (Net)|-5.33|STANDARD_ERROR_OF_MEAN|1.06|<|0.0001|TWO_SIDED|95.0|-7.41|-3.26||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.12 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 4.52 CPD between the 0.8 mg and 0.12 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-3.26|-7.41|<0.0001
71859491|NCT02250534|143233049|SUPERIORITY||Mean Difference (Net)|-7.54|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-9.51|-5.57||The p-value is Bonferroni-corrected for multiple comparisons with a priori threshold of significance P \< 0.0167|ANCOVA||Group difference = 0.03 mg nicotine - 0.8 mg nicotine|The statistical analysis method was ANCOVA, in order to test for statistically significant differences between group means, while controlling for covariates of interest. It was calculated that 207 subjects per group would be required to have at least 90% power to detect a mean difference of 6.07 CPD between the 0.8 mg and 0.03 mg groups at week 12, with significance level alpha of 0.0167. The significance level reflects the Bonferroni correction needed for testing of all pairwise comparisons.||-5.57|-9.51|<0.0001
71859492|NCT00817336|143233081|SUPERIORITY_OR_OTHER||Cohen's d|0.8||||0.02|TWO_SIDED||||||Mixed Models Analysis|||||||0.02
71859493|NCT00817336|143233082|SUPERIORITY||Cohen's d|2.3||||0.001|TWO_SIDED||||||Mixed Models Analysis|||||||0.001
71859494|NCT00817336|143233083|SUPERIORITY_OR_OTHER||Cohen's d|0.41||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||.31
71859495|NCT00817336|143233084|SUPERIORITY||Cohen's d|0.41||||0.41|TWO_SIDED||||||Mixed Models Analysis|||||||.41
71859496|NCT01182181|143233103|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.6|||||TWO_SIDED|90.0|92.34|98.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||98.95|92.34|
71859497|NCT01182181|143233104|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.3|||||TWO_SIDED|90.0|93.14|99.57|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||99.57|93.14|
71859498|NCT01121913|143233105|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
71859499|NCT01121913|143233105|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|105.0|||||TWO_SIDED|90.0|93.9|117.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||117|93.9|
71859500|NCT01121913|143233105|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|95.3|||||TWO_SIDED|90.0|85.5|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.5|
71859501|NCT01121913|143233105|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|97.7|||||TWO_SIDED|90.0|87.7|109.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||109|87.7|
71859502|NCT01121913|143233106|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|102.0|||||TWO_SIDED|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||114|91.8|
71859503|NCT01121913|143233106|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|106.0|||||TWO_SIDED|90.0|95.1|118.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||118|95.1|
71859504|NCT01121913|143233106|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|94.9|||||TWO_SIDED|90.0|85.1|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||106|85.1|
71859505|NCT01121913|143233106|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|98.4|||||TWO_SIDED|90.0|88.3|110.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||110|88.3|
71859506|NCT01121913|143233107|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|73.3|||||TWO_SIDED|90.0|63.2|85.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®|||85|63.2|
71859507|NCT01121913|143233107|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|59.8|||||TWO_SIDED|90.0|51.5|69.4|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®|||69.4|51.5|
71859508|NCT01121913|143233107|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|83.0|||||TWO_SIDED|90.0|71.5|96.4|||||Trazodone Contramid® OAD (prototype 2)/Triticco®|||96.4|71.5|
71681293|NCT00772005|142881193|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0630
71906651|NCT01148563|143335653|SUPERIORITY||Risk Ratio, log|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.094|TWO_SIDED|95.0|-0.65|0.05|||bootstrapping||The hypothesis test was based on ln(relative risk), with the tele-monitoring group value as the relative risk numerator and the control group value as the denominator. The standard error was generated by bootstrapping the sample.|||0.05|-0.65|0.094
71681294|NCT00772005|142881194|SUPERIORITY_OR_OTHER|||||||0.4607||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4607
71681295|NCT00772005|142881194|SUPERIORITY_OR_OTHER|||||||0.2538||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2538
71681296|NCT00772005|142881194|SUPERIORITY_OR_OTHER|||||||0.3406||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3406
71906652|NCT01148563|143335654|SUPERIORITY||Risk Ratio, log|0.7|STANDARD_ERROR_OF_MEAN|0.22||0.105|TWO_SIDED|95.0|0.45|1.08|||bootstrapping|The standard error was generated by bootstrapping the sample.|The hypothesis test was based on ln(relative risk) with the tele-monitoring group value as the numerator and the control group as the denominator.|||1.08|0.45|0.105
71906653|NCT01879319|143335655|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|-2.4|||||TWO_SIDED|95.0|-11.2|6.1||||||||6.1|-11.2|
71906654|NCT01879319|143335656|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.9|9.7||||||||9.7|-2.9|
71906655|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.567|TWO_SIDED|95.0|-0.052|0.14|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.140|-0.052|0.567
71906656|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|0.113||||0.015|TWO_SIDED|95.0|0.018|0.209|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.209|0.018|0.015
71906657|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.059|TWO_SIDED|95.0|-0.003|0.188|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.188|-0.003|0.059
71906658|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|0.069||||0.09|TWO_SIDED|95.0|-0.011|0.15|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.011|0.090
71906659|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|0.049||||0.231|TWO_SIDED|95.0|-0.031|0.129|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.129|-0.031|0.231
71681297|NCT00772005|142881195|SUPERIORITY_OR_OTHER|||||||0.8116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8116
71906660|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|-0.021||||0.612|TWO_SIDED|95.0|-0.101|0.059|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.059|-0.101|0.612
71906661|NCT03084718|143335662|SUPERIORITY||Mean Difference (Final Values)|0.102||||0.011|TWO_SIDED|95.0|0.023|0.18|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.180|0.023|0.011
71681298|NCT00772005|142881195|SUPERIORITY_OR_OTHER|||||||0.687||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6870
71906662|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|0.018||||0.647|TWO_SIDED|95.0|-0.06|0.097|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.097|-0.060|0.647
71906663|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.004|TWO_SIDED|95.0|0.039|0.196|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.196|0.039|0.004
71906664|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|0.071||||0.076|TWO_SIDED|95.0|-0.008|0.149|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.149|-0.008|0.076
71906665|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|0.099||||0.014|TWO_SIDED|95.0|0.02|0.179|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.179|0.020|0.014
71906666|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.192|TWO_SIDED|95.0|-0.026|0.131|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.131|-0.026|0.192
71906667|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.244|TWO_SIDED|95.0|-0.126|0.032|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.032|-0.126|0.244
71906668|NCT03084718|143335663|SUPERIORITY||Mean Difference (Final Values)|0.074||||0.06|TWO_SIDED|95.0|-0.003|0.151|||Mixed Models Analysis|||"Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.151|-0.003|0.060
71859509|NCT01121913|143233107|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|67.7|||||TWO_SIDED|90.0|58.4|78.5|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®|||78.5|58.4|
71859510|NCT04353817|143233134|SUPERIORITY||Least Squares (LS) Mean Difference|-2.26|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.81|||Mixed-effects Model for Repeated Measure|||||-1.81|-2.71|<0.0001
71859511|NCT04353817|143233135|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-47.1||This is the nominal p-value without multiplicity controlled.|Mixed-effects Model for Repeated Measure|||||-47.1|-55.3|<0.0001
71859512|NCT00002597|143233137|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.0309|TWO_SIDED|95.0|1.01|1.35|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.||1.35|1.01|0.0309
71859513|NCT00002597|143233138|SUPERIORITY||Hazard Ratio (HR)|1.86||||0.001|TWO_SIDED|95.0|1.27|2.74|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.74|1.27|0.001
71859514|NCT00002597|143233139|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.0013|TWO_SIDED|95.0|1.17|1.93|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.93|1.17|0.0013
71859515|NCT00002597|143233140|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.035|TWO_SIDED|95.0|1.03|2.06|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.06|1.03|0.035
71859516|NCT00002597|143233141|SUPERIORITY||Hazard Ratio (HR)|1.74|||<|0.001|TWO_SIDED|95.0|1.48|2.04|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||2.04|1.48|<0.001
71859517|NCT00002597|143233142|SUPERIORITY||Hazard Ratio (HR)|1.5|||<|0.001|TWO_SIDED|95.0|1.21|1.85|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||1.85|1.21|<0.001
71906669|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.012||||0.78|TWO_SIDED|95.0|-0.074|0.098|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.098|-0.074|0.780
71906670|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.086|TWO_SIDED|95.0|-0.011|0.162|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.162|-0.011|0.086
71906671|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.043||||0.324|TWO_SIDED|95.0|-0.043|0.129|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.129|-0.043|0.324
71906672|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.063||||0.153|TWO_SIDED|95.0|-0.024|0.15|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.150|-0.024|0.153
71859518|NCT00002597|143233143|SUPERIORITY||Hazard Ratio (HR)|2.06|||<|0.001|TWO_SIDED|95.0|1.34|3.16|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.||3.16|1.34|<0.001
71859519|NCT00002597|143233144|SUPERIORITY||Hazard Ratio (HR)|1.38|||<|0.001|TWO_SIDED|95.0|1.22|1.56|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Treatment arms were compared using the log-rank test (one-sided significance level of 0.025).||1.56|1.22|<0.001
71859520|NCT00002597|143233145|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71859521|NCT02654132|143233146|SUPERIORITY||Hazard Ratio (HR)|0.51||||0.0043|TWO_SIDED|95.0|0.32|0.82|||Log Rank|||||0.82|0.32|0.0043
71859522|NCT02654132|143233147|SUPERIORITY||Odds Ratio (OR)|4.62||||0.0002|TWO_SIDED|95.0|2.05|10.43|||Cochran-Mantel-Haenszel|||||10.43|2.05|0.0002
71859523|NCT02654132|143233148|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0217|TWO_SIDED|95.0|0.37|0.93|||Log Rank|||||0.93|0.37|0.0217
71859524|NCT02485899|143233177|OTHER||Hazard Ratio (HR)|0.14|||<|0.0001|TWO_SIDED|95.0|0.06|0.33|||Cox Proportional Hazards model|||||0.33|0.06|<0.0001
71859525|NCT02485899|143233178|OTHER||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED||||||Cox Proportional Hazards model|||||||<0.0001
71859526|NCT00823836|143233219|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of ropinirole PR/XR tablets to ropinirole IR tablets was assessed with a non-inferiority margin of 2.5.|Median Difference (Net)|0.34||||0.702|TWO_SIDED|95.0|-1.41|2.09||Analysis of covariance (ANCOVA) model: value of change from Week 0 at Week 24 = treatment group + Week 0 value|ANCOVA|||||2.09|-1.41|0.702
71859527|NCT03713320|143233281|SUPERIORITY|||||||0.9539|||||||Cochran-Mantel-Haenszel|||Comparison of the treatment groups is based on a Cochran-Mantel-Haenzel test controlling for the number of tumors at screening (at least one tumor at screening versus no tumors at screening) and number of prognostic factors (0-1 versus 2 prognostic factors). Prognostic factors include age at diagnosis \> 60 years and lactate dehydrogenase level \> upper limit of normal at diagnosis. Number of subjects achieving ORR4 and exact binomial (Clopper-Pearson) confidence intervals are presented.||||.9539
71859528|NCT03713320|143233282|SUPERIORITY|||||||0.011|||||||Regression, Cox|||Hazard ratio (cobomarsen/vorinostat) and p-value comparing the treatment groups is based on a Cox proportional hazards model. A hazard ratio \< 1 favors cobomarsen over vorinostat.||||0.011
71859529|NCT02271230|143233303|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.78|1.11||||||||1.11|0.78|
71906673|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.482|TWO_SIDED|95.0|-0.055|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.117|-0.055|0.482
71859530|NCT02271230|143233303|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.8|1.14||||||||1.14|0.80|
71859531|NCT02271230|143233304|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.81|1.09||||||||1.09|0.81|
71859532|NCT02271230|143233304|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.74|0.998||||||||0.998|0.74|
71859533|NCT03042299|143233312|EQUIVALENCE|The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0731|||||TWO_SIDED|90.0|-0.1088|-0.0373||||||||-0.0373|-0.1088|
71859534|NCT03042299|143233313|EQUIVALENCE|The difference in the LS means between formulations (TAK-536 pediatric formulation \[granules\]-TAK-536 commercial formulation \[tablet\]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0909|||||TWO_SIDED|90.0|-0.1573|-0.0244||||||||-0.0244|-0.1573|
71859535|NCT01438840|143233323|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71859536|NCT02804399|143233334|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|14.74|||||TWO_SIDED|90.0|12.78|17.01||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||17.01|12.78|
71859537|NCT02804399|143233335|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|23.88|||||TWO_SIDED|90.0|21.58|26.43||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||26.43|21.58|
71859538|NCT02804399|143233336|SUPERIORITY_OR_OTHER||Ratio of Geometric Mean|13.96|||||TWO_SIDED|90.0|12.09|16.12||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.||16.12|12.09|
71906674|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.463|TWO_SIDED|95.0|-0.119|0.054|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.054|-0.119|0.463
71906675|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.032||||0.453|TWO_SIDED|95.0|-0.052|0.117|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.117|-0.052|0.453
71859539|NCT04211389|143233357|SUPERIORITY||Odds Ratio (OR)|6.59|||<|0.0001|TWO_SIDED|95.0|3.17|13.7||Stratification by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|IGA Success at Week 8 Odds Ratio||13.70|3.17|<0.0001
71859540|NCT04211389|143233358|SUPERIORITY||Hazard Ratio (HR)|4.207|||<|0.0001|TWO_SIDED|95.0|3.029|5.844|||Log Rank|Unstratified log-rank test|HR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization.|Time to Achieve PASI-50||5.844|3.029|<0.0001
71859541|NCT04211389|143233359|SUPERIORITY||Odds Ratio (OR)|10.42|||<|0.0001|TWO_SIDED|95.0|4.49|24.19|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-75 at Week 8 Odds Ratio||24.19|4.49|<0.0001
71859542|NCT04211389|143233360|SUPERIORITY||Odds Ratio (OR)|8.51||||0.0002|TWO_SIDED|95.0|2.45|28.86|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|PASI-90 at Week 8 Odds Ratio||28.86|2.45|0.0002
71859543|NCT04211389|143233361|SUPERIORITY||Odds Ratio (OR)|11.18||||0.0004|TWO_SIDED|95.0|2.33|53.68|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site and baseline IGA per randomization with multiple imputation of missing data.|I-IGA Success at Week 8 Odds Ratio||53.68|2.33|0.0004
71859544|NCT04211389|143233362|SUPERIORITY||Odds Ratio (OR)|15.27||||0.0002|TWO_SIDED|95.0|3.1|75.35|||Cochran-Mantel-Haenszel|Stratified by pooled study site and baseline IGA with multiple imputation of missing data.|Common odds ratio stratified by pooled study site and baseline IGA with multiple imputation of missing data.|I-IGA Clear at Week 8 Odds Ratio||75.35|3.10|0.0002
71859545|NCT04211389|143233363|SUPERIORITY|WI-NRS Success at Week 2 Odds Ratio|Odds Ratio (OR)|2.56||||0.0026|TWO_SIDED|95.0|1.43|4.58|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||4.58|1.43|0.0026
71859546|NCT04211389|143233363|SUPERIORITY|WI-NRS Success at Week 4 Odds Ratio|Odds Ratio (OR)|4.93|||<|0.0001|TWO_SIDED|95.0|2.65|9.18|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||9.18|2.65|<0.0001
71859547|NCT04211389|143233363|SUPERIORITY|WI-NRS Success at Week 8 Odds Ratio|Odds Ratio (OR)|3.59|||<|0.0001|TWO_SIDED|95.0|2.07|6.23|||Cochran-Mantel-Haenszel|Stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|Common OR stratified by pooled study site, baseline IGA, and baseline intertriginous involvement per randomization with multiple imputation of missing data.|||6.23|2.07|<0.0001
71906676|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.533|TWO_SIDED|95.0|-0.064|0.123|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.123|-0.064|0.533
71681299|NCT00772005|142881195|SUPERIORITY_OR_OTHER|||||||0.8112||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8112
71859548|NCT04211389|143233364|SUPERIORITY||Mean Difference (Final Values)|-26.0|||<|0.0001|TWO_SIDED|95.0|-31.9|-20.0|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 4||-20.0|-31.9|<0.0001
71859549|NCT04211389|143233364|SUPERIORITY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-33.2|-19.7|||ANCOVA|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|Site, baseline IGA, baseline intertriginous involvement, and baseline PSD scores were independent variables, multiple imputation used for missing data|LS Mean Difference at Week 8||-19.7|-33.2|<0.0001
71906677|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.105||||0.029|TWO_SIDED|95.0|0.011|0.199|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.199|0.011|0.029
71906678|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.052||||0.274|TWO_SIDED|95.0|-0.041|0.146|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||0.146|-0.041|0.274
71906679|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.075||||0.119|TWO_SIDED|95.0|-0.019|0.169|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.169|-0.019|0.119
71906680|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.638|TWO_SIDED|95.0|-0.071|0.116|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.116|-0.071|0.638
71906681|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|-0.052||||0.274|TWO_SIDED|95.0|-0.147|0.042|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.042|-0.147|0.274
71906682|NCT03084718|143335664|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.092|TWO_SIDED|95.0|-0.013|0.171|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.171|-0.013|0.092
71906683|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.053|TWO_SIDED|95.0|-0.31|0.0|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.00|-0.31|0.053
71906684|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.001|TWO_SIDED|95.0|-0.42|-0.11|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.11|-0.42|0.001
71906685|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.006|TWO_SIDED|95.0|-0.37|-0.06|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.06|-0.37|0.006
71906686|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.176|TWO_SIDED|95.0|-0.26|0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.26|0.176
71906687|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.423|TWO_SIDED|95.0|-0.22|0.09|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.09|-0.22|0.423
71859550|NCT02357264|143233365|OTHER|||||||0.162|||||||Fisher Exact|||||||.162
71859551|NCT01062971|143233374|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71859552|NCT01062971|143233375|NON_INFERIORITY|Noninferiority was determined if the treatments did not show differences greater than 20%.|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71906688|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.574|TWO_SIDED|95.0|-0.11|0.2|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.20|-0.11|0.574
71906689|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.011|TWO_SIDED|95.0|-0.35|-0.05|||Mixed Models Analysis|||"Week 4~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.35|0.011
71906690|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.215|TWO_SIDED|95.0|-0.27|0.06|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo"||0.06|-0.27|0.215
71906691|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.07|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||0.01|-0.32|0.070
71906692|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.005|TWO_SIDED|95.0|-0.4|-0.07|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.07|-0.40|0.005
71906693|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.566|TWO_SIDED|95.0|-0.21|0.12|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.12|-0.21|0.566
71906694|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.124|TWO_SIDED|95.0|-0.29|0.04|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.04|-0.29|0.124
71906695|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.336|TWO_SIDED|95.0|-0.25|0.08|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.08|-0.25|0.336
71906696|NCT03084718|143335665|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.01|TWO_SIDED|95.0|-0.37|-0.05|||Mixed Models Analysis|||"Week 8~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.05|-0.37|0.010
71681300|NCT00772005|142881196|SUPERIORITY_OR_OTHER|||||||0.9786||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9786
71859553|NCT01182207|143233398|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.74|||||TWO_SIDED|90.0|86.82|107.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||107.79|86.82|
71859554|NCT01182207|143233399|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.16|||||TWO_SIDED|90.0|101.1|105.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||105.27|101.10|
71859555|NCT01182207|143233400|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.72|||||TWO_SIDED|90.0|100.67|104.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||104.80|100.67|
71859556|NCT01182207|143233401|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||TWO_SIDED|90.0|89.45|106.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||106.50|89.45|
71859557|NCT01182207|143233402|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.88|||||TWO_SIDED|90.0|95.62|102.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.25|95.62|
71859558|NCT01182207|143233403|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.2|||||TWO_SIDED|90.0|95.36|101.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.12|95.36|
71859559|NCT02053610|143233478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.0001|TWO_SIDED|95.0|0.41|0.58|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.58|0.41|<0.0001
71859560|NCT02053610|143233480|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.54|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|Stratified by Binet stage at Baseline.|||0.54|0.33|<0.0001
71859561|NCT02053610|143233482|SUPERIORITY_OR_OTHER||Difference in Response Rates|13.22||||0.0001|TWO_SIDED|95.0|6.3|20.1|||Chi-squared|||Includes participants with EOTR: CR, CRi, PR or nPR.||20.1|6.3|0.0001
71859562|NCT02053610|143233483|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.92||||0.0002|TWO_SIDED|95.0|6.1|19.8|||Chi-squared|||Includes participants with best overall response: CR, CRi, PR or nPR.||19.8|6.1|0.0002
71859563|NCT02053610|143233484|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.43|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.43|<0.0001
71859564|NCT02053610|143233485|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.76||||0.0245|TWO_SIDED|95.0|0.6|0.97|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.97|0.60|0.0245
71859565|NCT02053610|143233486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.61|0.41|<0.0001
71859566|NCT02053610|143233488|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73|||Log Rank, Stratified|Stratified by Binet stage at Baseline.||||0.73|0.46|<0.0001
71859567|NCT04486313|143233507|SUPERIORITY|||||||0.8786|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.8786
71859568|NCT04486313|143233508|SUPERIORITY|||||||0.074||||||Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness|Cochran-Mantel-Haenszel|||||||0.0740
71859569|NCT04486313|143233509|SUPERIORITY|||||||0.4479|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 4||||0.4479
71859570|NCT04486313|143233509|SUPERIORITY|||||||0.2814|||||||Cochran-Mantel-Haenszel|||Comparison of proportion positive for SARS-CoV-2 at Day 10||||0.2814
71859571|NCT04486313|143233510|SUPERIORITY|||||||0.0665|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 4||||0.0665
71859572|NCT04486313|143233510|SUPERIORITY|||||||0.4974|||||||t-test, 2 sided|||Comparison of change from Baseline to Day 10||||0.4974
71859573|NCT04486313|143233511|SUPERIORITY|||||||0.1771|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.1771
71859574|NCT04486313|143233512|SUPERIORITY|||||||0.2399|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.2399
71859575|NCT04486313|143233513|SUPERIORITY|||||||0.09|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.09
71859576|NCT04486313|143233514|SUPERIORITY|||||||0.0077|||||||Gehan-Wilcoxon Test|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.0077
71859577|NCT04486313|143233515|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
71859578|NCT04486313|143233516|SUPERIORITY|||||||0.05|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.05
71859579|NCT04486313|143233517|SUPERIORITY|||||||0.08|||||||Cochran-Mantel-Haenszel|Stratified by Baseline COVID-19 severity (mild/moderate), time from onset of symptoms to randomization (\<36 hours/≥36 hours), risk of severe illness||||||0.08
71906697|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.067|TWO_SIDED|95.0|-0.38|0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.01|-0.38|0.067
71906698|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.53|-0.14|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.53|< 0.001
71859580|NCT01657799|143233518|SUPERIORITY|||||||0.933|||||||Log Rank|Log-rank test stratified by graded prognostic assessment (GPA) score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.933
71859581|NCT01657799|143233518|SUPERIORITY|||||||0.909|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.||||0.909
71859582|NCT01657799|143233518|SUPERIORITY||Hazard Ratio (HR)|0.985||||0.927|TWO_SIDED|95.0|0.716|1.355|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.355|0.716|0.927
71859583|NCT01657799|143233518|SUPERIORITY||Hazard Ratio (HR)|0.981||||0.906|TWO_SIDED|95.0|0.71|1.354|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening. Nominal P-values were reported.||||1.354|0.710|0.906
71859584|NCT01657799|143233519|SUPERIORITY|||||||0.535|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.535
71859585|NCT01657799|143233519|SUPERIORITY|||||||0.898|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.898
71906699|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.038|TWO_SIDED|95.0|-0.4|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.40|0.038
71859586|NCT01657799|143233520|SUPERIORITY|||||||0.314|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.314
71859587|NCT01657799|143233520|SUPERIORITY|||||||0.536|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.536
71859588|NCT01657799|143233520|SUPERIORITY||Hazard Ratio (HR)|1.301||||0.313|TWO_SIDED|95.0|0.78|2.168|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.168|0.780|0.313
71859589|NCT01657799|143233520|SUPERIORITY||Hazard Ratio (HR)|1.181||||0.534|TWO_SIDED|95.0|0.698|1.999|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.999|0.698|0.534
71906700|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.13|TWO_SIDED|95.0|-0.35|0.05|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.05|-0.35|0.130
71906701|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.811|TWO_SIDED|95.0|-0.22|0.17|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.17|-0.22|0.811
71859590|NCT01657799|143233521|SUPERIORITY|||||||0.864|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.864
71859591|NCT01657799|143233521|SUPERIORITY|||||||0.301|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||||0.301
71859592|NCT01657799|143233521|SUPERIORITY||Hazard Ratio (HR)|1.047||||0.86|TWO_SIDED|95.0|0.626|1.754|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||1.754|0.626|0.860
71859593|NCT01657799|143233521|SUPERIORITY||Hazard Ratio (HR)|1.295||||0.289|TWO_SIDED|95.0|0.803|2.086|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or \> 2.5) at screening.||||2.086|0.803|0.289
71859594|NCT03539068|143233537|SUPERIORITY||||||<|1e-05|||||||Chi-squared|||||||<0.00001
71859595|NCT04599855|143233548|SUPERIORITY||least square (LS) means difference|-5.1|STANDARD_ERROR_OF_MEAN|1.42|<|0.001|TWO_SIDED|95.0|-7.91|-2.33|||Mixed model for repeated measures|||||-2.33|-7.91|<0.001
71859596|NCT04599855|143233548|SUPERIORITY||LS means difference|-6.8|STANDARD_ERROR_OF_MEAN|1.38|<|0.001|TWO_SIDED|95.0|-9.48|-4.07|||Mixed model for repeated measures|||||-4.07|-9.48|<0.001
71859597|NCT04599855|143233549|SUPERIORITY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.29|=|0.004|TWO_SIDED|95.0|-6.29|-1.22|||Mixed model for repeated measures|||||-1.22|-6.29|=0.004
71859598|NCT04599855|143233549|SUPERIORITY||LS means difference|-3.4|STANDARD_ERROR_OF_MEAN|1.24|=|0.006|TWO_SIDED|95.0|-5.89|-1.0|||Mixed model for repeated measures|||||-1.00|-5.89|=0.006
71859599|NCT02165397|143233550|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.0001|TWO_SIDED|95.0|0.148|0.42||The treatment effect was tested with a stratified log rank test.|Log Rank||The hazard ratio and its 95% confidence interval were based on a Cox regression model stratified by the randomization stratification factors.|||0.420|0.148|< 0.0001
71859600|NCT02165397|143233551|SUPERIORITY||Rate Ratio|2.526|||<|0.0001|TWO_SIDED|95.0|1.753|3.639||Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.|Cochran-Mantel-Haenszel|||||3.639|1.753|< 0.0001
71859601|NCT02165397|143233552|SUPERIORITY||Hazard Ratio (HR)|0.102|||<|0.0001|TWO_SIDED|95.0|0.049|0.212||P-value is from a stratified log-rank test.|Log Rank||Hazard ratio is estimated using a stratified Cox regression model.|||0.212|0.049|< 0.0001
71859602|NCT02165397|143233553|SUPERIORITY||Rate Ratio|1.813|||<|0.0001|TWO_SIDED|95.0|1.357|2.421|||Chi-squared|||||2.421|1.357|< 0.0001
71859603|NCT02165397|143233554|SUPERIORITY||Rate Ratio|1.238||||0.1059|TWO_SIDED|95.0|0.955|1.603||CMH chi squared test|Cochran-Mantel-Haenszel|||||1.603|0.955|0.1059
71859604|NCT02165397|143233555|SUPERIORITY||Hazard Ratio (HR)|0.808||||0.643|TWO_SIDED|95.0|0.328|1.99||P-value is from unstratified log rank test.|Log Rank||Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.|Data cutoff 18 December 2019||1.99|0.328|0.643
71859605|NCT00424554|143233563|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
71859606|NCT00236184|143233574|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||<0.001
71859607|NCT01772563|143233575|OTHER||Geometric mean ratio (GMR) [%]|93.63|||||TWO_SIDED|90.0|82.07|106.81|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=25.1.|"Statistical analysis of Volasertib:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||106.81|82.07|
71859608|NCT01772563|143233575|OTHER||Geometric mean ratio (GMR) [%]|75.77|||||TWO_SIDED|90.0|67.83|84.632|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=21.0.|"Statistical analysis of CD 10899:~AUC0-tz was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||84.632|67.830|
71906702|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.202|TWO_SIDED|95.0|-0.07|0.33|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.33|-0.07|0.202
71906703|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.044|TWO_SIDED|95.0|-0.39|-0.01|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.01|-0.39|0.044
71859609|NCT01772563|143233576|OTHER||Geometric mean ratio (GMR) [%]|79.4|||||TWO_SIDED|90.0|64.896|97.137|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=39.3.|"Statistical analysis of volasertib:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||97.137|64.896|
71859610|NCT01772563|143233576|OTHER||Geometric mean ratio (GMR) [%]|63.48|||||TWO_SIDED|90.0|55.372|72.775|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV%)=26.1.|"Statistical analysis of CD 10899:~Cmax was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||72.775|55.372|
71906704|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.283|TWO_SIDED|95.0|-0.37|0.11|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.11|-0.37|0.283
71906705|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.003|TWO_SIDED|95.0|-0.6|-0.13|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.13|-0.60|0.003
71859611|NCT01772563|143233577|OTHER||Geometric mean ratio (GMR) [%]|97.85|||||TWO_SIDED|90.0|87.09|109.94|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.7.|"Statistical analysis of volasertib:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||109.94|87.09|
71859612|NCT01772563|143233577|OTHER||Geometric mean ratio (GMR) [%]|77.42|||||TWO_SIDED|90.0|69.001|86.871|||||GMR (test/reference) i.e. (Volasertib+Itraconazole/ Volasertib). Intra- individual coefficient of variation (gCV %)=22.5.|"Statistical analysis of CD 10899:~AUC0-∞ was log-transformed prior to fitting an analysis of variance (ANOVA) model. This model included effects for 'treatment' and 'subject'. 90% confidence intervals (CIs) were computed, then back-transformed to the original scale to give the point estimator and interval estimates for the geometric mean ratio (GMR)."||86.871|69.001|
71859613|NCT01192776|143233579|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.76|1.98||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.98|0.76|
71859614|NCT01192776|143233579|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.78|1.87||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.87|0.78|
71859615|NCT01192776|143233579|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.53|1.35||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.53|
71859616|NCT01192776|143233580|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.16|||||TWO_SIDED|95.0|0.55|8.49||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||8.49|0.55|
71859617|NCT01192776|143233580|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|1.06|5.95||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||5.95|1.06|
71859618|NCT01192776|143233580|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.85|||||TWO_SIDED|95.0|0.79|4.31||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||4.31|0.79|
71906706|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.027|TWO_SIDED|95.0|-0.5|-0.03|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.50|0.027
71906707|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.054|TWO_SIDED|95.0|-0.48|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.00|-0.48|0.054
71906708|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.258|TWO_SIDED|95.0|-0.38|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.10|-0.38|0.258
71906709|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.423|TWO_SIDED|95.0|-0.14|0.34|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.34|-0.14|0.423
71906710|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.111|TWO_SIDED|95.0|-0.42|0.04|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.04|-0.42|0.111
71906711|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.135|TWO_SIDED|95.0|-0.36|0.05|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||0.05|-0.36|0.135
71906712|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.14|-0.56|< 0.001
71906713|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.024|TWO_SIDED|95.0|-0.44|-0.03|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.03|-0.44|0.024
71906714|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.067|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.01|-0.40|0.067
71906715|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.444|TWO_SIDED|95.0|-0.29|0.13|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.13|-0.29|0.444
71906716|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.285|TWO_SIDED|95.0|-0.09|0.32|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.32|-0.09|0.285
71859619|NCT01192776|143233585|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||TWO_SIDED|95.0|0.64|2.38||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.38|0.64|
71859620|NCT01192776|143233585|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.36|1.9||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.90|0.36|
71859621|NCT01192776|143233585|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.26|1.57||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.57|0.26|
71906717|NCT03084718|143335666|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.06|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||0.01|-0.40|0.060
71906718|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.115|TWO_SIDED|95.0|-1.1|10.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.0|-1.1|0.115
71859622|NCT01192776|143233587|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|0.63|2.77||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.77|0.63|
71859623|NCT01192776|143233587|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.42|||||TWO_SIDED|95.0|0.09|2.04||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.04|0.09|
71859624|NCT01192776|143233587|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.78|||||TWO_SIDED|95.0|0.2|2.99||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.99|0.20|
71859625|NCT01192776|143233588|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.65|||||TWO_SIDED|95.0|0.14|3.01||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.01|0.14|
71859626|NCT01192776|143233588|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.31|||||TWO_SIDED|95.0|0.44|3.91||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||3.91|0.44|
71859627|NCT01192776|143233588|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.28|||||TWO_SIDED|95.0|0.03|2.89||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.89|0.03|
71859628|NCT01192776|143233589|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.37|2.07||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||2.07|0.37|
71859629|NCT01192776|143233589|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.35||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.35|0.30|
71859630|NCT01192776|143233589|SUPERIORITY|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.13|1.64||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)||1.64|0.13|
71859631|NCT00736125|143233594|EQUIVALENCE|nonparametric data were analyzed using Mann Whitney U Tests|||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71859632|NCT00736125|143233595|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71859633|NCT03732820|143233613|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.81||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.81|0.54|<0.0001
71859634|NCT03732820|143233614|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0544|TWO_SIDED|95.0|0.67|1.0||A multiple testing procedure is employed across primary (rPFS) and key secondary endpoints (OS) to strongly control overall type 1 error at 2.5% one-sided. Alpha spend for OS will not exceed 0.02135.|Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.00|0.67|0.0544
71859635|NCT03732820|143233615|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0025|TWO_SIDED|95.0|0.64|0.9|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.90|0.64|0.0025
71859636|NCT03732820|143233616|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7456|TWO_SIDED|95.0|0.75|1.5|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.50|0.75|0.7456
71859637|NCT03732820|143233617|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.3099|TWO_SIDED|95.0|0.82|1.79|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.79|0.82|0.3099
71906719|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.008|TWO_SIDED|95.0|2.0|13.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|2.0|0.008
71906720|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.099|TWO_SIDED|95.0|-0.9|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-0.9|0.099
71906721|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.275|TWO_SIDED|95.0|-2.5|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.5|0.275
71906722|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.943|TWO_SIDED|95.0|-5.4|5.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.8|-5.4|0.943
71906723|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.308|TWO_SIDED|95.0|-8.6|2.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.7|-8.6|0.308
71906724|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|6.3||||0.024|TWO_SIDED|95.0|0.8|11.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||11.7|0.8|0.024
71906725|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.129|TWO_SIDED|95.0|-1.4|11.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.0|-1.4|0.129
71906726|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.8|15.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||15.2|2.8|0.004
71906727|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.061|TWO_SIDED|95.0|-0.3|12.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.1|-0.3|0.061
71906728|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.18|TWO_SIDED|95.0|-2.0|10.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.5|-2.0|0.180
71906729|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.721|TWO_SIDED|95.0|-5.1|7.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.4|-5.1|0.721
71906730|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|-3.1||||0.328|TWO_SIDED|95.0|-9.4|3.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-9.4|0.328
71681301|NCT00772005|142881196|SUPERIORITY_OR_OTHER|||||||0.5879||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5879
71906731|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.022|TWO_SIDED|95.0|1.0|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.2|1.0|0.022
71906732|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.101|TWO_SIDED|95.0|-0.9|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-0.9|0.101
71906733|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.003|TWO_SIDED|95.0|2.8|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.9|2.8|0.003
71906734|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.061|TWO_SIDED|95.0|-0.2|10.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.8|-0.2|0.061
71906735|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|3.7||||0.196|TWO_SIDED|95.0|-1.9|9.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.3|-1.9|0.196
71906736|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.814|TWO_SIDED|95.0|-4.9|6.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.3|-4.9|0.814
71906737|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.291|TWO_SIDED|95.0|-8.6|2.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||2.6|-8.6|0.291
71906738|NCT03084718|143335667|SUPERIORITY||Mean Difference (Final Values)|6.7||||0.016|TWO_SIDED|95.0|1.3|12.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.1|1.3|0.016
71906739|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71906740|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71906741|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71906742|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.913|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.913
71859638|NCT03732820|143233618|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.3212|TWO_SIDED|95.0|0.55|1.22|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.22|0.55|0.3212
71859639|NCT03732820|143233619|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0534|TWO_SIDED|95.0|0.59|0.99|||Log Rank|Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||0.99|0.59|0.0534
71859640|NCT00832000|143233622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68|STANDARD_DEVIATION|1.24|<|0.001|TWO_SIDED|95.0|-2.66|-0.706|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.706|-2.66|<0.001
71859641|NCT00832000|143233622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_DEVIATION|1.24||0.04||95.0|-3.85|-0.139|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.139|-3.85|0.04
71859642|NCT00832000|143233623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63|STANDARD_DEVIATION|1.19|<|0.001|TWO_SIDED|95.0|-2.0|-1.26|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.26|-2.00|<0.001
71859643|NCT00832000|143233624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_DEVIATION|1.27|<|0.001|TWO_SIDED|95.0|-1.67|-0.861|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.861|-1.67|<0.001
71859644|NCT00832000|143233625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.918|STANDARD_DEVIATION|1.29|<|0.001|TWO_SIDED|95.0|-1.3|-0.532|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.532|-1.30|<0.001
71859645|NCT00832000|143233626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.109|STANDARD_DEVIATION|0.563|<|0.001|TWO_SIDED|95.0|-0.177|-0.056|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.056|-0.177|<0.001
71859646|NCT00832000|143233627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_DEVIATION|13.1||0.09|TWO_SIDED|95.0|-0.68|9.75|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||9.75|-0.680|0.09
71859647|NCT00832000|143233628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.568|STANDARD_DEVIATION|0.6|<|0.001|TWO_SIDED|95.0|-0.812|-0.325|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.325|-0.812|<0.001
71906743|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.871|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.871
71906744|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.958|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.958
71906745|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71906746|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.01|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.010
71906747|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.011|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.011
71906748|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
71859648|NCT00832000|143233629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_DEVIATION|1.083|<|0.001|TWO_SIDED|95.0|-0.633|-0.142|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.142|-0.633|<0.001
71859649|NCT00832000|143233630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.313|STANDARD_DEVIATION|0.889|<|0.001|TWO_SIDED|95.0|-0.602|-0.149|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.149|-0.602|<0.001
71859650|NCT00832000|143233631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.464|STANDARD_DEVIATION|0.516|<|0.001|TWO_SIDED|95.0|-0.675|-0.254|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-0.254|-0.675|<0.001
71859651|NCT00832000|143233632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.69|STANDARD_DEVIATION|12.6||0.5|TWO_SIDED|95.0|-3.34|6.73|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||6.73|-3.34|0.50
71859652|NCT00832000|143233633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_DEVIATION|3.44|<|0.001|TWO_SIDED|95.0|-4.07|-1.3|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||-1.30|-4.07|<0.001
71859653|NCT00832000|143233634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.58|STANDARD_DEVIATION|5.35|<|0.001|TWO_SIDED|95.0|3.44|7.72|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.||7.72|3.44|<0.001
71859654|NCT00832000|143233635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|STANDARD_DEVIATION|6.5||0.9|TWO_SIDED|95.0|-5.87|5.17|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||5.17|-5.87|0.90
71859655|NCT00832000|143233635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|6.5||0.03|TWO_SIDED|95.0|0.941|20.6|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.||20.6|0.941|0.03
71859656|NCT03845075|143233639|SUPERIORITY||LS Mean Difference|3.6||||0.4671|TWO_SIDED|95.0|-6.58|13.78||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||13.78|-6.58|0.4671
71859657|NCT03845075|143233639|SUPERIORITY||LS Mean Difference|10.11||||0.1808|TWO_SIDED|95.0|-5.14|25.36||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||25.36|-5.14|0.1808
71859658|NCT03845075|143233639|SUPERIORITY||LS Mean Difference|4.63||||0.4171|TWO_SIDED|95.0|-7.08|16.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||16.33|-7.08|0.4171
71859659|NCT03845075|143233639|SUPERIORITY||LS Mean Difference|5.33||||0.3116|TWO_SIDED|95.0|-5.43|16.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||16.10|-5.43|0.3116
71906749|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.996|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.996
71906750|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.632|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.632
71906751|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.63|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.630
71906752|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71906753|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.002|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.002
71906754|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.001|TWO_SIDED|95.0|-0.2|0.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||-0.0|-0.2|0.001
71906755|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71859660|NCT03845075|143233639|SUPERIORITY||LS Mean Difference|5.8||||0.2353|TWO_SIDED|95.0|-4.12|15.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||15.72|-4.12|0.2353
71906756|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.96|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.960
71906757|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.725|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||0.1|-0.1|0.725
71906758|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.764|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||0.1|-0.1|0.764
71906759|NCT03084718|143335668|SUPERIORITY||Mean Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.2|-0.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||-0.1|-0.2|< 0.001
71906760|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.316|TWO_SIDED|95.0|-2.8|8.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.7|-2.8|0.316
71906761|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|4.9||||0.097|TWO_SIDED|95.0|-0.9|10.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.7|-0.9|0.097
71906762|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.128|TWO_SIDED|95.0|-1.3|10.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||10.2|-1.3|0.128
71906763|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.511|TWO_SIDED|95.0|-3.9|7.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.8|-3.9|0.511
71906764|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.61|TWO_SIDED|95.0|-4.3|7.3|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.3|-4.3|0.610
71906765|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.882|TWO_SIDED|95.0|-6.3|5.4|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.4|-6.3|0.882
71859661|NCT03845075|143233639|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||17.48|-5.76|0.3037
71906766|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|7.2||||0.013|TWO_SIDED|95.0|1.5|12.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||12.9|1.5|0.013
71906767|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.219|TWO_SIDED|95.0|-2.8|12.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||12.2|-2.8|0.219
71906768|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.166|TWO_SIDED|95.0|-2.2|12.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||12.8|-2.2|0.166
71906769|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.151|TWO_SIDED|95.0|-2.0|12.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.9|-2.0|0.151
71859662|NCT03845075|143233640|SUPERIORITY||LS Mean Difference|-1.31||||0.6543|TWO_SIDED|95.0|-7.33|4.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||4.72|-7.33|0.6543
71906770|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.871|TWO_SIDED|95.0|-6.9|8.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.2|-6.9|0.871
71906771|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.837|TWO_SIDED|95.0|-6.8|8.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.3|-6.8|0.837
71906772|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.966|TWO_SIDED|95.0|-7.4|7.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||7.7|-7.4|0.966
71906773|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|9.5||||0.012|TWO_SIDED|95.0|2.1|16.9|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||16.9|2.1|0.012
71906774|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.233|TWO_SIDED|95.0|-2.5|10.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||10.1|-2.5|0.233
71906775|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|5.1||||0.113|TWO_SIDED|95.0|-1.2|11.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.4|-1.2|0.113
71906776|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.12|TWO_SIDED|95.0|-1.3|11.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.2|-1.3|0.120
71859663|NCT03845075|143233640|SUPERIORITY||LS Mean Difference|0.94||||0.7941|TWO_SIDED|95.0|-6.5|8.38||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||8.38|-6.50|0.7941
71859664|NCT03845075|143233640|SUPERIORITY||LS Mean Difference|-2.0||||0.5937|TWO_SIDED|95.0|-9.72|5.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||5.73|-9.72|0.5937
71859665|NCT03845075|143233640|SUPERIORITY||LS Mean Difference|2.56||||0.5423|TWO_SIDED|95.0|-6.11|11.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||11.23|-6.11|0.5423
71906777|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.691|TWO_SIDED|95.0|-5.1|7.6|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.6|-5.1|0.691
71906778|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.722|TWO_SIDED|95.0|-5.2|7.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||7.5|-5.2|0.722
71906779|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.966|TWO_SIDED|95.0|-6.5|6.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.2|-6.5|0.966
71859666|NCT03845075|143233640|SUPERIORITY||LS Mean Difference|1.2||||0.7226|TWO_SIDED|95.0|-5.77|8.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||8.16|-5.77|0.7226
71859667|NCT03845075|143233640|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||10.16|-7.85|0.7912
71859668|NCT03845075|143233641|SUPERIORITY||LS Mean Difference|-1.35||||0.7023|TWO_SIDED|95.0|-8.67|5.97||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 4; Safety set; LOCF||5.97|-8.67|0.7023
71859669|NCT03845075|143233641|SUPERIORITY||LS Mean Difference|-0.48||||0.9012|TWO_SIDED|95.0|-8.58|7.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 8; Safety set; LOCF||7.61|-8.58|0.9012
71859670|NCT03845075|143233641|SUPERIORITY||LS Mean Difference|2.14||||0.6138|TWO_SIDED|95.0|-6.63|10.92||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 12; Safety set; LOCF||10.92|-6.63|0.6138
71906780|NCT03084718|143335669|SUPERIORITY||Mean Difference (Final Values)|8.3||||0.008|TWO_SIDED|95.0|2.2|14.5|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||14.5|2.2|0.008
71906781|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.426|TWO_SIDED|95.0|-3.4|7.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||7.9|-3.4|0.426
71681302|NCT00772005|142881196|SUPERIORITY_OR_OTHER|||||||0.3973||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3973
71859671|NCT03845075|143233641|SUPERIORITY||LS Mean Difference|1.23||||0.7889|TWO_SIDED|95.0|-8.26|10.72||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 16; Safety set; LOCF||10.72|-8.26|0.7889
71859672|NCT03845075|143233641|SUPERIORITY||LS Mean Difference|0.3||||0.9536|TWO_SIDED|95.0|-10.34|10.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 20; Safety set; LOCF||10.94|-10.34|0.9536
71906782|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.055|TWO_SIDED|95.0|-0.1|11.2|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.2|-0.1|0.055
71906783|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|5.4||||0.059|TWO_SIDED|95.0|-0.2|11.1|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||11.1|-0.2|0.059
71906784|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.263|TWO_SIDED|95.0|-2.5|9.0|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.0|-2.5|0.263
71906785|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.28|TWO_SIDED|95.0|-2.6|8.8|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.8|-2.6|0.280
71859673|NCT03845075|143233641|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24; Safety set; LOCF||12.12|-6.72|0.5551
71859674|NCT03845075|143233645|SUPERIORITY||LS Mean Difference|-2.52||||0.7782|TWO_SIDED|95.0|-21.23|16.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||16.20|-21.23|0.7782
71859675|NCT03845075|143233645|SUPERIORITY||LS Mean Difference|-7.26||||0.313|TWO_SIDED|95.0|-22.09|7.56||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||7.56|-22.09|0.3130
71859676|NCT03845075|143233645|SUPERIORITY||LS Mean Difference|-5.73||||0.4033|TWO_SIDED|95.0|-19.92|8.47||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48||8.47|-19.92|0.4033
71859677|NCT03845075|143233646|SUPERIORITY||LS Mean Difference|-7.5||||0.0325|TWO_SIDED|95.0|-14.29|-0.71||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24||-0.71|-14.29|0.0325
71859678|NCT03845075|143233646|SUPERIORITY||LS Mean Difference|-0.32||||0.9394|TWO_SIDED|95.0|-9.04|8.4||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48||8.40|-9.04|0.9394
71859679|NCT03845075|143233646|SUPERIORITY||LS Mean Difference|6.91||||0.0135|TWO_SIDED|95.0|1.65|12.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 28||12.18|1.65|0.0135
71859680|NCT03845075|143233647|SUPERIORITY||LS Mean Difference|-4.17||||0.1048|TWO_SIDED|95.0|-9.31|0.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed.||0.98|-9.31|0.1048
71859681|NCT03845075|143233647|SUPERIORITY||LS Mean Difference|-0.99||||0.7189|TWO_SIDED|95.0|-6.75|4.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT observed.||4.77|-6.75|0.7189
71859682|NCT03845075|143233647|SUPERIORITY||LS Mean Difference|3.09||||0.1053|TWO_SIDED|95.0|-0.73|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT observed.||6.91|-0.73|0.1053
71859683|NCT03845075|143233648|SUPERIORITY||LS Mean Difference|-3.12||||0.0033|TWO_SIDED|95.0|-5.02|-1.21||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||-1.21|-5.02|0.0033
71859684|NCT03845075|143233648|SUPERIORITY||LS Mean Difference|0.58||||0.6663|TWO_SIDED|95.0|-2.24|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||3.41|-2.24|0.6663
71859685|NCT03845075|143233648|SUPERIORITY||LS Mean Difference|3.59||||0.0058|TWO_SIDED|95.0|1.21|5.98||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||5.98|1.21|0.0058
71859686|NCT03845075|143233649|SUPERIORITY||LS Mean Difference|-3.02||||0.0713|TWO_SIDED|95.0|-6.34|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed||0.30|-6.34|0.0713
71859687|NCT03845075|143233649|SUPERIORITY||LS Mean Difference|-2.48||||0.1457|TWO_SIDED|95.0|-5.92|0.96||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.96|-5.92|0.1457
71859688|NCT03845075|143233649|SUPERIORITY||LS Mean Difference|0.85||||0.1837|TWO_SIDED|95.0|-0.45|2.15||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||2.15|-0.45|0.1837
71859689|NCT03845075|143233650|SUPERIORITY||LS Mean Difference|-0.05||||0.7926|TWO_SIDED|95.0|-0.42|0.33||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT LOCF||0.33|-0.42|0.7926
71906786|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.965|TWO_SIDED|95.0|-5.9|5.6|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||5.6|-5.9|0.965
71906787|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.007|TWO_SIDED|95.0|2.2|13.3|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.3|2.2|0.007
71906788|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.308|TWO_SIDED|95.0|-3.5|11.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.2|-3.5|0.308
71906789|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|5.8||||0.124|TWO_SIDED|95.0|-1.6|13.2|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.2|-1.6|0.124
71906790|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.063|TWO_SIDED|95.0|-0.4|14.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||14.3|-0.4|0.063
71859690|NCT03845075|143233650|SUPERIORITY||LS Mean Difference|-0.27||||0.2124|TWO_SIDED|95.0|-0.72|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 48; mITT LOCF||0.17|-0.72|0.2124
71859691|NCT03845075|143233650|SUPERIORITY||LS Mean Difference|-0.14||||0.6084|TWO_SIDED|95.0|-0.72|0.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Week 24 to Week 48; mITT LOCF||0.43|-0.72|0.6084
71859692|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|16.0||||0.0905|TWO_SIDED|95.0|-2.85|34.85||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to week 24; mITT observed. (Like to eat something fatty)||34.85|-2.85|0.0905
71859693|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|6.65||||0.6285|TWO_SIDED|95.0|-22.05|35.36||P-value from ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Like some meat/fish)||35.36|-22.05|0.6285
71859694|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-6.81||||0.5884|TWO_SIDED|95.0|-33.05|19.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something salty).||19.43|-33.05|0.5884
71859695|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|2.98||||0.8533|TWO_SIDED|95.0|-30.73|36.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate.|Baseline to Week 24; mITT observed. (Eat something sweet).||36.68|-30.73|0.8533
71859696|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-17.33||||0.1529|TWO_SIDED|95.0|-41.87|7.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like to eat something fatty).||7.20|-41.87|0.1529
71859697|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-11.75||||0.3399|TWO_SIDED|95.0|-37.15|13.65||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Like some meat/fish).||13.65|-37.15|0.3399
71906791|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.602|TWO_SIDED|95.0|-5.5|9.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-5.5|0.602
71906792|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.402|TWO_SIDED|95.0|-4.3|10.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||10.6|-4.3|0.402
71906793|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.753|TWO_SIDED|95.0|-6.3|8.6|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||8.6|-6.3|0.753
71906794|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|10.2||||0.006|TWO_SIDED|95.0|2.9|17.4|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||17.4|2.9|0.006
71906795|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.331|TWO_SIDED|95.0|-3.1|9.2|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.2|-3.1|0.331
71681303|NCT00772005|142881197|SUPERIORITY_OR_OTHER|||||||0.403||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4030
71859698|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-23.95||||0.0673|TWO_SIDED|95.0|-49.84|1.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something salty).||1.93|-49.84|0.0673
71859699|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-22.6||||0.1657|TWO_SIDED|95.0|-55.65|10.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Eat something sweet).||10.46|-55.65|0.1657
71859700|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-30.18||||0.0108|TWO_SIDED|95.0|-52.31|-8.06||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like to eat something fatty).||-8.06|-52.31|0.0108
71859701|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-14.79||||0.171|TWO_SIDED|95.0|-36.71|7.13||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Like some meat/fish).||7.13|-36.71|0.1710
71859702|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-19.86||||0.0083|TWO_SIDED|95.0|-33.8|-5.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something salty).||-5.93|-33.80|0.0083
71859703|NCT03845075|143233651|SUPERIORITY||LS Mean Difference|-22.98||||0.0631|TWO_SIDED|95.0|-47.39|1.43||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Eat something sweet).||1.43|-47.39|0.0631
71859704|NCT03845075|143233652|SUPERIORITY||LS Mean Difference|-2.56||||0.8082|TWO_SIDED|95.0|-24.65|19.53||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed.||19.53|-24.65|0.8082
71859705|NCT03845075|143233652|SUPERIORITY||LS Mean Difference|-1.42||||0.9034|TWO_SIDED|95.0|-25.94|23.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||23.10|-25.94|0.9034
71859706|NCT03845075|143233652|SUPERIORITY||LS Mean Difference|-7.0||||0.4658|TWO_SIDED|95.0|-26.93|12.93||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||12.93|-26.93|0.4658
71859707|NCT03845075|143233653|SUPERIORITY||LS Mean Difference|-5.68||||0.0537|TWO_SIDED|95.0|-11.46|0.1||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT LOCF.||0.10|-11.46|0.0537
71859708|NCT03845075|143233653|SUPERIORITY||LS Mean Difference|-2.69||||0.3772|TWO_SIDED|95.0|-8.98|3.61||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF.||3.61|-8.98|0.3772
71859709|NCT03845075|143233653|SUPERIORITY||LS Mean Difference|3.03||||0.1171|TWO_SIDED|95.0|-0.85|6.91||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF.||6.91|-0.85|0.1171
71859710|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|-0.05||||0.8623|TWO_SIDED|95.0|-0.59|0.5||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in total cholesterol)||0.50|-0.59|0.8623
71906796|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.073|TWO_SIDED|95.0|-0.5|11.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||11.9|-0.5|0.073
71906797|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|6.2||||0.048|TWO_SIDED|95.0|0.1|12.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||12.4|0.1|0.048
71681304|NCT00772005|142881197|SUPERIORITY_OR_OTHER|||||||0.3777||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3777
71859711|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.03||||0.8327|TWO_SIDED|95.0|-0.25|0.3||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in HDL cholesterol)||0.30|-0.25|0.8327
71859712|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|-0.06||||0.808|TWO_SIDED|95.0|-0.53|0.42||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in LDL cholesterol)||0.42|-0.53|0.8080
71859713|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.22||||0.5791|TWO_SIDED|95.0|-0.62|1.07|||ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 24; mITT observed. (Change in triglycerides)||1.07|-0.62|0.5791
71859714|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.03||||0.9337|TWO_SIDED|95.0|-0.71|0.77||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in cholesterol)||0.77|-0.71|0.9337
71859715|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.01||||0.9305|TWO_SIDED|95.0|-0.21|0.23||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in HDL cholesterol)||0.23|-0.21|0.9305
71859716|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.09||||0.691|TWO_SIDED|95.0|-0.4|0.59||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in LDL cholesterol)||0.59|-0.40|0.6910
71859717|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.35||||0.2688|TWO_SIDED|95.0|-0.3|1.01||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Baseline to Week 48; mITT LOCF. (Change in triglycerides)||1.01|-0.30|0.2688
71859718|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.06||||0.8262|TWO_SIDED|95.0|-0.54|0.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in cholesterol)||0.67|-0.54|0.8262
71859719|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|-0.02||||0.8293|TWO_SIDED|95.0|-0.2|0.17||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in HDL cholesterol)||0.17|-0.20|0.8293
71859720|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.11||||0.5486|TWO_SIDED|95.0|-0.27|0.49||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in LDL cholesterol)||0.49|-0.27|0.5486
71859721|NCT03845075|143233654|SUPERIORITY||LS Mean Difference|0.24||||0.3226|TWO_SIDED|95.0|-0.26|0.75||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Change in triglycerides)||0.75|-0.26|0.3226
71906798|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|2.6||||0.41|TWO_SIDED|95.0|-3.6|8.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.9|-3.6|0.410
71681305|NCT00772005|142881197|SUPERIORITY_OR_OTHER|||||||0.6493||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6493
71906799|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED|95.0|-3.1|9.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||9.4|-3.1|0.320
71906800|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.867|TWO_SIDED|95.0|-5.7|6.8|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.8|-5.7|0.867
71681306|NCT00772005|142881198|SUPERIORITY_OR_OTHER|||||||0.9871||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9871
71906801|NCT03084718|143335670|SUPERIORITY||Mean Difference (Final Values)|9.0||||0.004|TWO_SIDED|95.0|2.9|15.0|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.0|2.9|0.004
71906802|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|4.0||||0.26|TWO_SIDED|95.0|-3.2|11.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||11.9|-3.2|0.260
71906803|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.387|TWO_SIDED|95.0|-4.2|10.9|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||10.9|-4.2|0.387
71906804|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.574|TWO_SIDED|95.0|-5.4|9.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||9.7|-5.4|0.574
71906805|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.799|TWO_SIDED|95.0|-8.6|6.7|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.7|-8.6|0.799
71906806|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.577|TWO_SIDED|95.0|-9.8|5.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||5.5|-9.8|0.577
71859722|NCT03845075|143233655|SUPERIORITY||LS Mean Difference|0.59||||0.842|TWO_SIDED|95.0|-5.55|6.73||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Physical component score)||6.73|-5.55|0.8420
71859723|NCT03845075|143233655|SUPERIORITY||LS Mean Difference|-1.74||||0.6693|TWO_SIDED|95.0|-10.15|6.67||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Mental component score)||6.67|-10.15|0.6693
71859724|NCT03845075|143233655|SUPERIORITY||LS Mean Difference|-1.83||||0.5444|TWO_SIDED|95.0|-8.12|4.46||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Physical component score)||4.46|-8.12|0.5444
71906807|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.764|TWO_SIDED|95.0|-8.8|6.5|||Mixed Models Analysis|||"Inter-visit period 1~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||6.5|-8.8|0.764
71906808|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.097|TWO_SIDED|95.0|-1.1|13.8|||Mixed Models Analysis|||"Inter-visit period 1~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.8|-1.1|0.097
71906809|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.908|TWO_SIDED|95.0|-9.9|8.8|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||8.8|-9.9|0.908
71681307|NCT00772005|142881198|SUPERIORITY_OR_OTHER|||||||0.5859||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5859
71859725|NCT03845075|143233655|SUPERIORITY||LS Mean Difference|-1.85||||0.5595|TWO_SIDED|95.0|-8.47|4.76||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; mITT LOCF. (Mental component score)||4.76|-8.47|0.5595
71906810|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|7.0||||0.135|TWO_SIDED|95.0|-2.2|16.5|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||16.5|-2.2|0.135
71906811|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.786|TWO_SIDED|95.0|-10.7|8.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo"||8.1|-10.7|0.786
71906812|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.109|TWO_SIDED|95.0|-1.7|17.1|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||17.1|-1.7|0.109
71906813|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-10.1|8.7|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||8.7|-10.1|0.876
71906814|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-8.0||||0.08|TWO_SIDED|95.0|-17.9|1.0|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||1.0|-17.9|0.080
71906815|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.202|TWO_SIDED|95.0|-3.2|15.3|||Mixed Models Analysis|||"Inter-visit period 2~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||15.3|-3.2|0.202
71906816|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|2.0||||0.635|TWO_SIDED|95.0|-5.9|9.7|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment A (CHF 718 pMDI 100 µg TDD) vs Treatment D (Placebo)"||9.7|-5.9|0.635
71859726|NCT03845075|143233655|SUPERIORITY||LS Mean Difference|-2.07||||0.4331|TWO_SIDED|95.0|-7.54|3.41||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Physical component score)||3.41|-7.54|0.4331
71859727|NCT03845075|143233655|SUPERIORITY||LS Mean Difference|-1.44||||0.6427|TWO_SIDED|95.0|-7.9|5.03||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|Week 24 to week 48; mITT LOCF. (Mental component score)||5.03|-7.90|0.6427
71859728|NCT03845075|143233657|SUPERIORITY||LS Mean Difference|5.86||||0.3037|TWO_SIDED|95.0|-5.76|17.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in systolic blood pressure)||17.48|-5.76|0.3037
71859729|NCT03845075|143233657|SUPERIORITY||LS Mean Difference|1.15||||0.7912|TWO_SIDED|95.0|-7.85|10.16||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in diastolic blood pressure)||10.16|-7.85|0.7912
71859730|NCT03845075|143233657|SUPERIORITY||LS Mean Difference|10.29||||0.1773|TWO_SIDED|95.0|-5.25|25.83||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in systolic blood pressure)||25.83|-5.25|0.1773
71859731|NCT03845075|143233657|SUPERIORITY||LS Mean Difference|1.32||||0.798|TWO_SIDED|95.0|-9.55|12.2||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in diastolic blood pressure)||12.20|-9.55|0.7980
71859732|NCT03845075|143233657|SUPERIORITY||LS Mean Difference|7.77||||0.158|TWO_SIDED|95.0|-3.4|18.94||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in systolic blood pressure)||18.94|-3.40|0.1580
71859733|NCT03845075|143233657|SUPERIORITY||LS Mean Difference|1.64||||0.7021|TWO_SIDED|95.0|-7.36|10.64||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in diastolic blood pressure)||10.64|-7.36|0.7021
71859734|NCT03845075|143233658|SUPERIORITY||LS Mean Difference|1.5||||0.8728|TWO_SIDED|95.0|-18.17|21.18||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in systolic blood pressure mean)||21.18|-18.17|0.8728
71859735|NCT03845075|143233658|SUPERIORITY||LS Mean Difference|2.46||||0.5714|TWO_SIDED|95.0|-6.61|11.54||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; mITT LOCF. (Change in diastolic blood pressure mean)||11.54|-6.61|0.5714
71859736|NCT03845075|143233658|SUPERIORITY||LS Mean Difference|-10.15||||0.2322|TWO_SIDED|95.0|-27.51|7.22||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in systolic blood pressure mean)||7.22|-27.51|0.2322
71859737|NCT03845075|143233658|SUPERIORITY||LS Mean Difference|-3.46||||0.4321|TWO_SIDED|95.0|-12.61|5.68||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 12; mITT LOCF. (Change in diastolic blood pressure mean)||5.68|-12.61|0.4321
71859738|NCT03845075|143233661|SUPERIORITY||LS Mean Difference|2.7||||0.5551|TWO_SIDED|95.0|-6.72|12.12||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 24; safety set LOCF. (Change in heart rate)||12.12|-6.72|0.5551
71906817|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.191|TWO_SIDED|95.0|-2.6|13.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment D (Placebo)"||13.1|-2.6|0.191
71906818|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.914|TWO_SIDED|95.0|-7.4|8.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment D (Placebo)"||8.3|-7.4|0.914
71906819|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.407|TWO_SIDED|95.0|-4.6|11.3|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment B (CHF 718 pMDI 400 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||11.3|-4.6|0.407
71906820|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.718|TWO_SIDED|95.0|-9.4|6.4|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment A (CHF 718 pMDI 100 µg TDD)"||6.4|-9.4|0.718
71681308|NCT00772005|142881198|SUPERIORITY_OR_OTHER|||||||0.0328||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0328
71681309|NCT00772005|142881199|SUPERIORITY_OR_OTHER|||||||0.2318||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2318
71681310|NCT00772005|142881199|SUPERIORITY_OR_OTHER|||||||0.6211||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6211
71681311|NCT00772005|142881199|SUPERIORITY_OR_OTHER|||||||0.3125||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3125
71681312|NCT00772005|142881200|SUPERIORITY_OR_OTHER|||||||0.2425||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2425
71859739|NCT03845075|143233661|SUPERIORITY||LS Mean Difference|-2.13||||0.7256|TWO_SIDED|95.0|-14.88|10.63||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From baseline to week 48; safety set LOCF. (Change in heart rate)||10.63|-14.88|0.7256
71859740|NCT03845075|143233661|SUPERIORITY||LS Mean Difference|-3.29||||0.4822|TWO_SIDED|95.0|-13.05|6.48||P-value from an ANCOVA model with treatment as factor and baseline as covariate.|ANCOVA||(Tesofensine/Metoprolol -\> Tesofensine/Metoprolol) - (Placebo -\> Tesofensine/Metoprolol). Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment as factor and baseline as covariate|From week 24 to week 48; safety set LOCF. (Change in heart rate)||6.48|-13.05|0.4822
71859741|NCT00935259|143233662|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|STANDARD_DEVIATION|52.1||0.455||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||||||0.455
71859742|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-51.7||||0.014||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 16:00||||0.014
71859743|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 18:3n3||||<0.001
71859744|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.217||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n6||||0.217
71859745|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.666||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n9||||0.666
71859746|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.776||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:5n6||||0.776
71859747|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.018||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:6n3||||0.018
71859748|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.152||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Lysophosphatidylcholine 20:4n6||||0.152
71859749|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.1||||0.007||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 18:2n6||||0.007
71681313|NCT00772005|142881200|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
71681314|NCT00772005|142881200|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4753
71859750|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8||||0.325||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:3n6||||0.325
71859751|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.3||||0.419||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:4n6||||0.419
71859752|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.07||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n3||||0.070
71859753|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.769||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n6||||0.769
71859754|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylethanolamine 18:2n6||||<0.001
71859755|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-240.8||||0.016||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 16:00||||0.016
71859756|NCT00935259|143233663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.833||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 20:3n9||||0.833
71859757|NCT00935259|143233664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.027||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fasted||||0.027
71681315|NCT00772005|142881201|SUPERIORITY_OR_OTHER|||||||0.1715||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1715
71859758|NCT00935259|143233664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fed||||<0.001
71859759|NCT00935259|143233666|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:4n6 / c20:3n6||||0.247
71859760|NCT00935259|143233666|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||Mixed Models Analysis|||Cholesterol ester c20:5n3 / c20:4n3||||0.151
71859761|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-2.99|STANDARD_ERROR_OF_MEAN|0.81||0.0002|TWO_SIDED|95.0|-4.58|-1.4|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance (ANCOVA) model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-1.40|-4.58|0.0002
71859762|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-3.78|STANDARD_ERROR_OF_MEAN|0.82|<|0.0001|TWO_SIDED|95.0|-5.38|-2.17|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-2.17|-5.38|<.0001
71859763|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-6.07|STANDARD_ERROR_OF_MEAN|0.87|<|0.0001|TWO_SIDED|95.0|-7.77|-4.36|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.36|-7.77|<.0001
71859764|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-6.68|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-8.28|-5.09|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-5.09|-8.28|<.0001
71681316|NCT00772005|142881201|SUPERIORITY_OR_OTHER|||||||0.3056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3056
71681317|NCT00772005|142881201|SUPERIORITY_OR_OTHER|||||||0.0083||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0083
71681318|NCT00772005|142881202|SUPERIORITY_OR_OTHER|||||||0.2681||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2681
71681319|NCT00772005|142881202|SUPERIORITY_OR_OTHER|||||||0.1475||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1475
71906821|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.235|TWO_SIDED|95.0|-12.7|3.1|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment C (CHF 718 pMDI 800 µg TDD) vs Treatment B (CHF 718 pMDI 400 µg TDD)"||3.1|-12.7|0.235
71906822|NCT03084718|143335671|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.118|TWO_SIDED|95.0|-1.6|13.9|||Mixed Models Analysis|||"Entire treatment period~Comparison treatment groups were:~Treatment E (QVAR\^®, 320 µg TDD) vs Treatment D (Placebo)"||13.9|-1.6|0.118
71906823|NCT00844649|143335678|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.617|0.835||P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.835|0.617|<0.0001
71859765|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-7.79|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-9.42|-6.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-6.16|-9.42|<.0001
71859766|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-5.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|-7.61|-4.35|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-4.35|-7.61|<.0001
71859767|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|2.99|STANDARD_ERROR_OF_MEAN|0.82||0.0003|TWO_SIDED|95.0|1.38|4.6|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||4.60|1.38|0.0003
71906824|NCT00844649|143335679|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.581|0.821||P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.|||0.821|0.581|<0.0001
71681320|NCT00772005|142881202|SUPERIORITY_OR_OTHER|||||||0.0647||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0647
71859768|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|2.2|STANDARD_ERROR_OF_MEAN|0.83||0.0082|TWO_SIDED|95.0|0.57|3.84|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||3.84|0.57|0.0082
71859769|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-0.09|STANDARD_ERROR_OF_MEAN|0.88||0.9209|TWO_SIDED|95.0|-1.82|1.64|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||1.64|-1.82|0.9209
71859770|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-0.7|STANDARD_ERROR_OF_MEAN|0.83||0.396|TWO_SIDED|95.0|-2.33|0.92|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||0.92|-2.33|0.3960
71859771|NCT03856047|143233667|SUPERIORITY||Treatment difference (%-points)|-1.81|STANDARD_ERROR_OF_MEAN|0.84||0.0316|TWO_SIDED|95.0|-3.46|-0.16|||ANCOVA|||Week 26 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline (week 0) body weight as covariate. For each treatment arm, multiple (x1000) imputation of intermittend missing data was done using Markov Chain Monte Carlo, followed by sequential regression for monotone missing values of body weight including sex and region as factors.||-0.16|-3.46|0.0316
71681321|NCT00772005|142881203|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1670
71859772|NCT00874497|143233700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0824||||0.1761|TWO_SIDED|95.0|-0.0378|0.2025||P-values are based on Analysis of Covariance (ANCOVA) model of the change FEV1 from baseline to the specified study week using treatment group and current smoking status as fixed effects and the baseline FEV1 value as a covariate.|ANCOVA|||Statistical analysis at Week 104.||0.2025|-0.0378|0.1761
71859773|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.904||||0.139|TWO_SIDED|95.0|-6.77|0.97|||ANCOVA|||Statistical analysis of Right Upper region of the lung at Week 104.||0.97|-6.77|0.139
71859774|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.46|TWO_SIDED|95.0|-4.46|2.04|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||2.04|-4.46|0.460
71859775|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.176||||0.457|TWO_SIDED|95.0|-7.98|3.63|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||3.63|-7.98|0.457
71859776|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.167||||0.362|TWO_SIDED|95.0|-6.88|2.54|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||2.54|-6.88|0.362
71859777|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.225||||0.67|TWO_SIDED|95.0|-6.94|4.48|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||4.48|-6.94|0.670
71859778|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.218||||0.244|TWO_SIDED|95.0|-5.98|1.55|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||1.55|-5.98|0.244
71859779|NCT00874497|143233701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.374||||0.574|TWO_SIDED|95.0|-6.23|3.48|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||3.48|-6.23|0.574
71859780|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97||||0.436|TWO_SIDED|95.0|-1.53|3.47|||ANCOVA|||Statistical analysis of Right Upper region of the Lung at Week 104.||3.47|-1.53|0.436
71859781|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31||||0.067|TWO_SIDED|95.0|-0.17|4.79|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.||4.79|-0.17|0.067
71859782|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97||||0.163|TWO_SIDED|95.0|-0.83|4.77|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.||4.77|-0.83|0.163
71859783|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.27||||0.102|TWO_SIDED|95.0|-0.48|5.02|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.||5.02|-0.48|0.102
71859784|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11||||0.162|TWO_SIDED|95.0|-0.89|5.12|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.||5.12|-0.89|0.162
71859785|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78||||0.16|TWO_SIDED|95.0|-0.73|4.29|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.||4.29|-0.73|0.160
71859786|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.08||||0.122|TWO_SIDED|95.0|-0.58|4.75|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.||4.75|-0.58|0.122
71859787|NCT00874497|143233703|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05||||0.106|TWO_SIDED|95.0|-0.46|4.56|||ANCOVA|||Statistical analysis of Whole Lung region of the Lung at Week 104.||4.56|-0.46|0.106
71859788|NCT00874497|143233704|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.423||||0.469|TWO_SIDED|95.0|-5.32|2.48|||ANCOVA|||LS Mean Difference between Tetomilast and Placebo at Week 104.||2.48|-5.32|0.469
71859789|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.519|TWO_SIDED|95.0|-4.42|2.27|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||2.27|-4.42|0.519
71859790|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.463|TWO_SIDED|95.0|-3.92|1.82|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104.||1.82|-3.92|0.463
71681322|NCT00772005|142881203|SUPERIORITY_OR_OTHER|||||||0.1737||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1737
71681323|NCT00772005|142881203|SUPERIORITY_OR_OTHER|||||||0.372||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3720
71681324|NCT00772005|142881204|SUPERIORITY_OR_OTHER|||||||0.3547||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3547
71859791|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.598|TWO_SIDED|95.0|-6.74|3.94|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104.||3.94|-6.74|0.598
71859792|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.142|TWO_SIDED|95.0|-6.92|1.03|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||1.03|-6.92|0.142
71859793|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.757|TWO_SIDED|95.0|-6.26|4.59|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||4.59|-6.26|0.757
71859794|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27||||0.5|TWO_SIDED|95.0|-5.03|2.5|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||2.50|-5.03|0.500
71859795|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.353|TWO_SIDED|95.0|-6.09|2.23|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||2.23|-6.09|0.353
71859796|NCT00874497|143233705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.438|TWO_SIDED|95.0|-5.43|2.4|||ANCOVA|||Statistical analysis of whole region of the lung at Week 104.||2.40|-5.43|0.438
71859797|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|351487.0||||0.22|TWO_SIDED|95.0|-219976.0|922951.0|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.||922951|-219976|0.220
71681325|NCT00772005|142881204|SUPERIORITY_OR_OTHER|||||||0.6043||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6043
71681326|NCT00772005|142881204|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0463
71859798|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|103036.0||||0.146|TWO_SIDED|95.0|-37651.0|243723.0|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104||243723|-37651|0.146
71859799|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|247358.0||||0.322|TWO_SIDED|95.0|-252728.0|747444.0|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104||747444|-252728|0.322
71859800|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|362384.0||||0.141|TWO_SIDED|95.0|-126518.0|851286.0|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.||851286|-126518|0.141
71859801|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|294202.0||||0.325|TWO_SIDED|95.0|-303329.0|891733.0|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.||891733|-303329|0.325
71859802|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|575882.0||||0.258|TWO_SIDED|95.0|-439692.0|1591457.0|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.||1591457|-439692|0.258
71859803|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|589373.0||||0.247|TWO_SIDED|95.0|-426928.0|1605673.0|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.||1605673|-426928|0.247
71681327|NCT00772005|142881205|SUPERIORITY_OR_OTHER|||||||0.9258||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9258
71906825|NCT00844649|143335680|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|3.19|||<|0.0001|TWO_SIDED|95.0|2.178|4.662|||Chi-squared||Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone|PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.||4.662|2.178|<0.0001
71906826|NCT02767856|143335685|EQUIVALENCE|The study did not enroll enough samples. The stats here are only for reference.|Mean Difference (Net)|0.04||||0.48|TWO_SIDED|95.0|-0.08|0.16|||t-test, 2 sided|||Baseline and primary visit outcome||0.16|-0.08|0.48
71906827|NCT02767856|143335686|EQUIVALENCE|The study did not reach the target sample size. the stats are for reference.|Mean Difference (Final Values)|0.12||||0.26|TWO_SIDED|95.0|-0.75|0.99|||t-test, 2 sided|||||0.99|-0.75|0.26
71906828|NCT02767856|143335687|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|26.3||||0.26|TWO_SIDED|95.0|-21.75|74.2|||t-test, 2 sided|||||74.20|-21.75|0.26
71859804|NCT00874497|143233706|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1156318.0||||0.251|TWO_SIDED|95.0|-855009.0|3167645.0|||ANCOVA|||Statistical analysis of whole lung region of the lung at Week 104.||3167645|-855009|0.251
71859805|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.9||||0.181|TWO_SIDED|95.0|-38.0|193.8|||ANCOVA|||Statistical analysis of right upper lung region (RV) at Week 104.||193.8|-38.0|0.181
71859806|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9||||0.781|TWO_SIDED|95.0|-48.8|36.9|||ANCOVA|||Statistical analysis of right middle lung region (RV) at Week 104.||36.9|-48.8|0.781
71859807|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.7||||0.445|TWO_SIDED|95.0|-77.8|173.2|||ANCOVA|||Statistical analysis of right lower lung region (RV) at Week 104.||173.2|-77.8|0.445
71906829|NCT02767856|143335688|EQUIVALENCE|The study did not reach the target sample size. The stats are for reference.|Mean Difference (Final Values)|11.1||||0.44|TWO_SIDED|95.0|-41.3|19.3|||t-test, 2 sided|||||19.3|-41.3|0.44
71906830|NCT00091026|143335689|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.22|TWO_SIDED|95.0|-13.0|14.0|||Chi-squared|||||14|-13|0.22
71906831|NCT00091026|143335690|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|||||||0.95
71906832|NCT00091026|143335691|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Log Rank|||||||0.86
71906833|NCT00589979|143335692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.78||||0.1006||95.0|0.89|3.55||All statistical tests were 2-sided with a significance level of alpha=0.05.|Cox frailty model|Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.|The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.|The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.||3.55|0.89|0.1006
71921996|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|-0.8|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-5.5|3.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||3.9|-5.5|
71859808|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.6||||0.259|TWO_SIDED|95.0|-48.1|173.2|||ANCOVA|||Statistical analysis of left upper lung region (RV) at Week 104.||173.2|-48.1|0.259
71859809|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.0||||0.639|TWO_SIDED|95.0|-105.6|169.6|||ANCOVA|||Statistical analysis of left lower lung region (RV) at Week 104.||169.6|-105.6|0.639
71859810|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|102.3||||0.408|TWO_SIDED|95.0|-145.9|350.5|||ANCOVA|||Statistical analysis of right whole lung region (RV) at Week 104.||350.5|-145.9|0.408
71859811|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85.2||||0.445|TWO_SIDED|95.0|-138.8|309.2|||ANCOVA|||Statistical analysis of left whole lung region (RV) at Week 104.||309.2|-138.8|0.445
71921997|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.2|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-4.6|4.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||4.9|-4.6|
71921998|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|2.1|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-6.5|10.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.7|-6.5|
71921999|NCT03091920|143364987|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-7.9|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-7.9|
71922000|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|6.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-4.4|16.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||16.8|-4.4|
71922001|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|9.1|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-1.5|19.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 1 hour||19.8|-1.5|
71922002|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-9.0|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||9.0|-9.0|
71922003|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|4.4|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|-4.6|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 4 hour||13.4|-4.6|
71922004|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-7.5|7.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||7.1|-7.5|
71681328|NCT00772005|142881205|SUPERIORITY_OR_OTHER|||||||0.9116||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9116
71859812|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|187.6||||0.421|TWO_SIDED|95.0|-279.6|654.8|||ANCOVA|||Statistical analysis of whole lung region (RV) at Week 104.||654.8|-279.6|0.421
71681329|NCT00772005|142881205|SUPERIORITY_OR_OTHER|||||||0.4848||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4848
71859813|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.7||||0.353|TWO_SIDED|95.0|-58.5|159.9|||ANCOVA|||Statistical analysis of right upper lung region (TLC) at Week 104.||159.9|-58.5|0.353
71859814|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.66|TWO_SIDED|95.0|-35.3|55.0|||ANCOVA|||Statistical analysis of right middle lung region (TLC) at Week 104.||55.0|-35.3|0.660
71681330|NCT00772005|142881206|SUPERIORITY_OR_OTHER|||||||0.7612||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7612
71681331|NCT00772005|142881206|SUPERIORITY_OR_OTHER|||||||0.5761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5761
71681332|NCT00772005|142881206|SUPERIORITY_OR_OTHER|||||||0.1576||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1576
71681333|NCT00772005|142881207|SUPERIORITY_OR_OTHER|||||||0.9565||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9565
71859815|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7||||0.859|TWO_SIDED|95.0|-110.7|132.1|||ANCOVA|||Statistical analysis of right lower lung region (TLC) at Week 104.||132.1|-110.7|0.859
71859816|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.5||||0.253|TWO_SIDED|95.0|-38.4|141.4|||ANCOVA|||Statistical analysis of left upper lung region (TLC)at Week 104.||141.4|-38.4|0.253
71859817|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.3||||0.754|TWO_SIDED|95.0|-126.0|172.6|||ANCOVA|||Statistical analysis of left lower lung region (TLC) at Week 104.||172.6|-126.0|0.754
71859818|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.2||||0.546|TWO_SIDED|95.0|-145.1|269.5|||ANCOVA|||Statistical analysis of right whole lung region (TLC) at Week 104.||269.5|-145.1|0.546
71906834|NCT00589979|143335694|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86||||0.1272||95.0|0.86|4.02||The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.|Regression, Logistic|The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.||4.02|0.86|0.1272
71906835|NCT00589979|143335695|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.0224||95.0|-1.01|-0.08||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.08|-1.01|0.0224
71906836|NCT00589979|143335696|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.2747||95.0|-0.31|1.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects regression||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||1.09|-0.31|0.2747
71906837|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4498||95.0|-0.8|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.80|0.4498
71906838|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.1065||95.0|-1.11|0.11||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.11|-1.11|0.1065
71681334|NCT00772005|142881207|SUPERIORITY_OR_OTHER|||||||0.9178||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9178
71922005|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.6|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.7|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose AM 8 hour||8.9|-5.7|
71859819|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.9||||0.554|TWO_SIDED|95.0|-155.5|285.3|||ANCOVA|||Statistical analysis of left whole lung region (TLC) at Week 104.||285.3|-155.5|0.554
71859820|NCT00874497|143233707|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|132.2||||0.524|TWO_SIDED|95.0|-284.9|549.4|||ANCOVA|||Statistical analysis of whole lung region (TLC) at Week 104.||549.4|-284.9|0.524
71859821|NCT00874497|143233708|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5843|TWO_SIDED|95.0|-0.07|0.04|||ANCOVA|||||0.04|-0.07|0.5843
71859822|NCT00874497|143233709|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249||||0.1252|TWO_SIDED|95.0|-0.073|0.571|||ANCOVA|||||0.571|-0.073|0.1252
71859823|NCT00874497|143233710|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1835||||0.4661|TWO_SIDED|95.0|-0.6892|0.3221|||ANCOVA|||||0.3221|-0.6892|0.4661
71859824|NCT00874497|143233711|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.134|TWO_SIDED|95.0|-0.19|1.4|||ANCOVA|||||1.40|-0.19|0.134
71859825|NCT00874497|143233712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.074|TWO_SIDED|95.0|-1.5|0.07|||ANCOVA|||Statistical analysis for sRaw||0.07|-1.50|0.074
71859826|NCT00874497|143233712|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.155|TWO_SIDED|95.0|-0.09|0.52|||ANCOVA|||Statistical analysis for sGaw||0.52|-0.09|0.155
71859827|NCT00874497|143233713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.845|TWO_SIDED|95.0|-0.77|0.64|||ANCOVA|||Statistical analysis for mean prior daily breath symptoms||0.64|-0.77|0.845
71859828|NCT00874497|143233713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.549|TWO_SIDED|95.0|-0.52|0.94|||ANCOVA|||Statistical analysis for mean prior daily cough symptoms||0.94|-0.52|0.549
71859829|NCT00874497|143233713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.717|TWO_SIDED|95.0|-0.93|0.65|||ANCOVA|||Statistical analysis for mean prior daily sputum symptoms||0.65|-0.93|0.717
71859830|NCT00874497|143233715|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level I (self management) at week 104.||||1.000
71681335|NCT00772005|142881207|SUPERIORITY_OR_OTHER|||||||0.1491||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1491
71859831|NCT00874497|143233715|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Statistical analysis for level II (physician visit) at week 104.||||1.0000
71859832|NCT00874497|143233715|SUPERIORITY_OR_OTHER|||||||0.5092|||||||Fisher Exact|||Statistical analysis for level III (hospital visit) at week 104.||||0.5092
71859833|NCT00874497|143233716|SUPERIORITY_OR_OTHER|||||||0.63||||||Fisher's Exact test was used to determine whether the tetomilast and placebo groups differ in the proportion of participants who experienced Level 2 or higher COPD exacerbations during the study.|Fisher Exact|||Statistical analysis at Week 104||||0.630
71859834|NCT00665223|143233727|SUPERIORITY|This analysis compared ACR16 45 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.36||||0.456|TWO_SIDED|97.5|-1.44|0.72|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.72|-1.44|0.456
71859835|NCT00665223|143233727|SUPERIORITY|This analysis compared ACR16 90 mg vs. placebo during the randomization phase.|Mean Difference (Final Values)|-0.99||||0.042|TWO_SIDED|97.5|-2.08|0.1|||ANCOVA|||The analysis of covariance (ANCOVA) main effects model included a term for treatment and covariates for baseline mMS, gender, and use of antipsychotic medication.||0.10|-2.08|0.042
71859836|NCT00905359|143233735|NON_INFERIORITY_OR_EQUIVALENCE|t-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if \<0.025 or the upper limit of the CI is less than 10%.||||||0.172|||||||t-test, 1 sided|||||||0.172
71859837|NCT00243022|143233750|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||t-test, 2 sided|||||||0.9
71859838|NCT00243022|143233751|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||||||0.12
71859839|NCT00243022|143233752|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||||||0.8
71859840|NCT04706793|143233803|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
71859841|NCT04706793|143233804|OTHER||Risk Difference (RD)|28.57|||||TWO_SIDED|95.0|6.28|50.86||||||||50.86|6.28|
71922006|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-2.0|12.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.1|-2.0|
71681336|NCT00772005|142881208|SUPERIORITY_OR_OTHER|||||||0.7056||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7056
71922007|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.2|STANDARD_ERROR_OF_MEAN|3.4|||TWO_SIDED|95.0|-1.8|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, pre-dose PM||12.3|-1.8|
71681337|NCT00772005|142881208|SUPERIORITY_OR_OTHER|||||||0.5179||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5179
71859842|NCT04706793|143233805|OTHER||Risk Difference (RD)|32.14|||||TWO_SIDED|95.0|9.58|54.71||||||||54.71|9.58|
71859843|NCT04706793|143233806|OTHER||Risk Difference (RD)|21.43|||||TWO_SIDED|95.0|-0.07|42.92||||||||42.92|-0.07|
71859844|NCT04706793|143233807|OTHER||Risk Difference (RD)|17.86|||||TWO_SIDED|95.0|-3.1|38.82||||||||38.82|-3.10|
71859845|NCT04706793|143233808|OTHER||Risk Difference (RD)|7.14|||||TWO_SIDED|95.0|-2.4|16.68||||||||16.68|-2.40|
71859846|NCT02601209|143233812|OTHER||Maximum Tolerated Dose (mg)|30.0|||||TWO_SIDED|||||||||||||
71859847|NCT02601209|143233813|SUPERIORITY||Hazard Ratio (HR)|1.36||||0.1419|ONE_SIDED|85.0||1.7|||Log Rank|1-sided statistical test and p-value||||1.70||0.1419
71859848|NCT03636373|143233825|NON_INFERIORITY|On a 10 point Likert Pain Scale, non-inferiority margin for the difference is 1.04. Using a Student t-test, there was 80% power for the difference in pain levels to exceed -1.04.||||||1|||||||t-test, 1 sided|||Mean Outcome measure Etanercept arm { ( 8 + 0 + 7)/3 = 5} Triamcinolone Arm { (3+0) /2 = 1.5 }||||1.00
71859849|NCT03636373|143233826|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.00
71859850|NCT03636373|143233827|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71859851|NCT03636373|143233828|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71859852|NCT03636373|143233829|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71859853|NCT03636373|143233830|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71859854|NCT01161628|143233877|SUPERIORITY_OR_OTHER||||||<|0.5|TWO_SIDED||||||t-test, 2 sided|||Null hypothesis: p (CR rate) is 0.5 or less versus... Alternative hypothesis: p \>0.5 A sample size of 25 patients gives 90% power with an alpha = 0.05||||<0.5
71859855|NCT00715117|143233886|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
71859856|NCT00715117|143233886|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71859857|NCT00715117|143233887|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Bowel symptoms||||>0.05
71859858|NCT00715117|143233887|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||Social well-being||||0.035
71859859|NCT00715117|143233887|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Emotional well-being||||>0.05
71859860|NCT00715117|143233887|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|95.0||||Systemic symptoms|t-test, 2 sided|||||||0.035
71859861|NCT00715117|143233887|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Body Image||||>0.05
71859862|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Sleep disturbance||||1.0
71859863|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||0.45|||||||Fisher Exact|||Unusual dreams||||0.45
71859864|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Twitching||||1.0
71859865|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Headaches||||1.0
71859866|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Decreased appetite||||1.0
71859867|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Nausea||||1.0
71859868|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Hair loss||||1.0
71859869|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Fatigue||||1.0
71859870|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Flushed ears||||1.0
71859871|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Papules, rash||||1.0
71859872|NCT00715117|143233888|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Double vision||||1.0
71859873|NCT01482429|143233889|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||binomial test|||||||0.03
71859874|NCT01482429|143233890|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71859875|NCT02037256|143233925|OTHER||percentage|0.24|||||TWO_SIDED|95.0|0.07|0.5||||||Median time to engraftment||0.50|0.07|
71859876|NCT02166476|143233932|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Noninferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference for overall success at EOIVT was \>-15%.|Treatment difference|4.5|||||TWO_SIDED|95.0|0.7|9.1|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||9.1|0.7|
71859877|NCT02166476|143233933|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the m-MITT Population.|Treatment difference|9.0|||||TWO_SIDED|95.0|-0.9|18.7|||||Treatment difference is the estimate of the difference in the Eradication rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population||18.7|-0.9|
71859878|NCT02166476|143233934|NON_INFERIORITY_OR_EQUIVALENCE|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the ME Population.|Treatment Difference|5.9|||||TWO_SIDED|95.0|-4.2|16.0|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the ME population||16.0|-4.2|
71906839|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.0484||95.0|-0.94|0.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||-0.00|-0.94|0.0484
71859879|NCT01076244|143233971|SUPERIORITY_OR_OTHER||change from baseline|13.43|STANDARD_DEVIATION|16.55|<|0.0001|TWO_SIDED|95.0|8.42|18.43|||t-test, 2 sided|||||18.43|8.42|<0.0001
71859880|NCT01076244|143233973|SUPERIORITY_OR_OTHER||change from baseline|2.17|STANDARD_DEVIATION|3.29|<|0.0001|TWO_SIDED|95.0|1.17|3.16|||t-test, 2 sided|||||3.16|1.17|<0.0001
71859881|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.05||||0.8916|TWO_SIDED|95.0|-0.81|0.7|||ANCOVA|||||0.70|-0.81|0.8916
71859882|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.22||||0.5569|TWO_SIDED|95.0|-0.95|0.51|||ANCOVA|||||0.51|-0.95|0.5569
71859883|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.53||||0.1544|TWO_SIDED|95.0|-1.25|0.2|||ANCOVA|||||0.20|-1.25|0.1544
71859884|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.94||||0.0137|TWO_SIDED|95.0|-1.69|-0.19|||ANCOVA|||||-0.19|-1.69|0.0137
71859885|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.88||||0.0171|TWO_SIDED|95.0|-1.61|0.16|||ANCOVA|||||0.16|-1.61|0.0171
71859886|NCT01496365|143234000|SUPERIORITY||Least square means|-1.01||||0.006|TWO_SIDED|95.0|-1.74|-0.29|||ANCOVA|||||-0.29|-1.74|0.0060
71859887|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.17||||0.7051|TWO_SIDED|95.0|-1.03|0.69|||ANCOVA|||||0.69|-1.03|0.7051
71859888|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.47||||0.2772|TWO_SIDED|95.0|-1.33|0.38|||ANCOVA|||||0.38|-1.33|0.2772
71859889|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.89||||0.0458|TWO_SIDED|95.0|-1.77|-0.02|||ANCOVA|||||-0.02|-1.77|0.0458
71859890|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.83||||0.0569|TWO_SIDED|95.0|-1.69|0.02|||ANCOVA|||||0.02|-1.69|0.0569
71859891|NCT01496365|143234000|SUPERIORITY||Least squares mean|-0.96||||0.0271|TWO_SIDED|95.0|-1.81|-0.11|||ANCOVA|||||-0.11|-1.81|0.0271
71859892|NCT02706951|143234013|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|26.5|||<|0.001|TWO_SIDED|95.0|17.5|35.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||35.6|17.5|<0.001
71859893|NCT02706951|143234013|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|30.0|||<|0.001|TWO_SIDED|95.0|21.0|38.9||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||38.9|21.0|<0.001
71859894|NCT02706951|143234014|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|25.3|||<|0.001|TWO_SIDED|95.0|16.8|33.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||33.7|16.8|<0.001
71859895|NCT02706951|143234014|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|33.6|||<|0.001|TWO_SIDED|95.0|25.1|42.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||42.1|25.1|<0.001
71859896|NCT02706951|143234015|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Least Squares (LS) Mean Difference|-1.08|||<|0.001|TWO_SIDED|95.0|-1.32|-0.85||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.85|-1.32|<0.001
71859897|NCT02706951|143234015|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.64|-1.17||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-1.17|-1.64|<0.001
71859898|NCT02706951|143234016|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.22||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.22|-0.43|<0.001
71859899|NCT02706951|143234016|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.51|-0.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate|||-0.30|-0.51|<0.001
71859900|NCT02706951|143234017|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|3.97|||<|0.001|TWO_SIDED|95.0|2.52|5.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||5.42|2.52|<0.001
71859901|NCT02706951|143234017|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|5.87|||<|0.001|TWO_SIDED|95.0|4.42|7.32||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||7.32|4.42|<0.001
71859902|NCT02706951|143234018|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|12.8|26.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||26.8|12.8|<0.001
71859903|NCT02706951|143234018|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|32.1|||<|0.001|TWO_SIDED|95.0|24.6|39.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||39.7|24.6|<0.001
71859904|NCT02706951|143234019|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-41.53||||0.001|TWO_SIDED|95.0|-66.56|-16.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-16.50|-66.56|0.001
71859905|NCT02706951|143234019|SUPERIORITY|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-49.31|||<|0.001|TWO_SIDED|95.0|-74.23|-24.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-24.40|-74.23|<0.001
71922008|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-5.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||9.6|-5.1|
71859906|NCT02706951|143234020|SUPERIORITY||Response Rate Difference|26.7|||<|0.001|TWO_SIDED|95.0|18.5|34.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||34.8|18.5|<0.001
71681338|NCT00772005|142881208|SUPERIORITY_OR_OTHER|||||||0.4585||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4585
71859907|NCT02706951|143234020|SUPERIORITY||Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|28.6|45.0||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||45.0|28.6|<0.001
71859908|NCT02706951|143234021|SUPERIORITY||Response Rate Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.8|25.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||25.8|13.8|<0.001
71681339|NCT00772005|142881209|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0690
71859909|NCT02706951|143234021|SUPERIORITY||Response Rate Difference|30.2|||<|0.001|TWO_SIDED|95.0|23.6|36.9||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate|||36.9|23.6|<0.001
71859910|NCT01777334|143234022|SUPERIORITY_OR_OTHER||Least squares mean difference|0.112|||<|0.001|TWO_SIDED|95.0|0.081|0.144|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.|||0.144|0.081|<0.001
71859911|NCT04294667|143234024|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|14.6||||0.011|TWO_SIDED|95.0|3.3|25.8|||Cochran-Mantel-Haenszel|||||25.8|3.3|0.0110
71859912|NCT04294667|143234025|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.9||||0.1776|TWO_SIDED|95.0|-3.6|19.4|||Cochran-Mantel-Haenszel|||||19.4|-3.6|0.1776
71859913|NCT04294667|143234026|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|10.8||||0.0518|TWO_SIDED|95.0|-0.1|21.7|||Cochran-Mantel-Haenszel|||||21.7|-0.1|0.0518
71859914|NCT04294667|143234027|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the CMH risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|11.5||||0.0257|TWO_SIDED|95.0|1.4|21.6|||Cochran-Mantel-Haenszel|||||21.6|1.4|0.0257
71859915|NCT04294667|143234028|SUPERIORITY|The difference in proportion responding between SOC+DZP 24mg/kg and SOC+PBO was estimated and tested using the Cochran-Mantel-Haenszel (CMH) risk difference estimate controlling for the randomization stratification factors, Pooled Region (North America vs Western Europe/Asia-Pacific vs Latin America/Eastern Europe), Screening disease activity (chronic active vs acute flaring) and Screening SLEDAI score (\<10 vs \>=10).|Difference in Proportions (%)|7.2||||0.1042|TWO_SIDED|95.0|-1.5|16.0|||Cochran-Mantel-Haenszel|||||16.0|-1.5|0.1042
71859916|NCT04294667|143234029|SUPERIORITY||Difference of Change(DZP+SOC vs PBO+SOC)|-1.8||||0.0001|TWO_SIDED|95.0|-2.7|-0.9|||MMRM|The Least Squares (LS) Mean, the difference (DZP+SOC versus PBO+SOC), and the 95% CIs was computed from the MMRM.||||-0.9|-2.7|0.0001
71922009|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-6.0|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, post-dose PM 1 hour||8.7|-6.0|
71922010|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.0|6.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.9|-5.0|
71859917|NCT04294667|143234034|SUPERIORITY|||||||0.0111|||||||Log Rank|||||||0.0111
71859918|NCT04294667|143234035|SUPERIORITY|||||||0.0228|||||||Log Rank|||||||0.0228
71859919|NCT01841697|143234066|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.|Difference in least squares mean|-0.03|||||TWO_SIDED|95.0|-0.15|0.08|||||Difference is omarigliptin minus sitagliptin.|Constrained longitudinal data analysis||0.08|-0.15|
71859920|NCT01841697|143234067|SUPERIORITY_OR_OTHER||Difference in percent|-4.3|||||TWO_SIDED|95.0|-11.8|3.2|||||Difference is omarigliptin minus sitagliptin.|||3.2|-11.8|
71859921|NCT01841697|143234068|SUPERIORITY_OR_OTHER||Difference in percent|-1.3|||||TWO_SIDED|95.0|-3.6|0.8|||||Difference is omarigliptin minus sitagliptin.|||0.8|-3.6|
71681340|NCT00772005|142881209|SUPERIORITY_OR_OTHER|||||||0.5324||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5324
71681341|NCT00772005|142881209|SUPERIORITY_OR_OTHER|||||||0.0946||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0946
71859922|NCT01841697|143234069|SUPERIORITY_OR_OTHER||Difference in least squares mean|-4.2||||0.089|TWO_SIDED|95.0|-9.0|0.6|||Constrained logitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|Difference is omarigliptin minus sitagliptin.|||0.6|-9.0|0.089
71859923|NCT01841697|143234070|SUPERIORITY_OR_OTHER||Between-group rate difference|2.0||||0.619|TWO_SIDED|95.0|-5.9|9.9|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||9.9|-5.9|0.619
71859924|NCT01841697|143234071|SUPERIORITY_OR_OTHER||Between-group rate difference|4.4||||0.212|TWO_SIDED|95.0|-2.5|11.4|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.||11.4|-2.5|0.212
71906840|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.4973||95.0|-0.93|0.46||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.46|-0.93|0.4973
71906841|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3966||95.0|-0.16|0.41||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.41|-0.16|0.3966
71906842|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6941||95.0|-0.53|0.35||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.35|-0.53|0.6941
71681342|NCT00772005|142881210|SUPERIORITY_OR_OTHER|||||||0.1878||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1878
71859925|NCT00364377|143234093|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student's two-tailed t-test for paired samples. Between-group comparisons were made using Student's two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose||||>0.05
71859926|NCT00632021|143234095|EQUIVALENCE|In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.|Incidence Rate Ratio (IRR)|0.92|||||TWO_SIDED|95.0|0.77|1.09||||||||1.09|0.77|
71859927|NCT00632021|143234096|EQUIVALENCE|The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.|Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.63|1.28||||||||1.28|0.63|
71681343|NCT00772005|142881210|SUPERIORITY_OR_OTHER|||||||0.4294||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4294
71859928|NCT03563313|143234097|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71859929|NCT03563313|143234098|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71859930|NCT03563313|143234099|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71859931|NCT03563313|143234100|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71859932|NCT03563313|143234101|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71859933|NCT03563313|143234102|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71859934|NCT00458393|143234150|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.577|STANDARD_ERROR_OF_MEAN|0.105||0.002|TWO_SIDED|95.0|0.404|0.824||secondary p-value given.|Log Rank|stratified by site|Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100\*(1-HR)|Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.||.824|.404|0.002
71859935|NCT00458393|143234151|SUPERIORITY||Risk Ratio (RR)|1.33||||0.28|TWO_SIDED|95.0|0.79|2.25||p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p \< 0.05|Fisher Exact||||Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/|2.25|0.79|0.28
71681344|NCT00772005|142881210|SUPERIORITY_OR_OTHER|||||||0.6504||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6504
71859936|NCT00458393|143234152|SUPERIORITY||Risk Ratio (RR)|1.3||||0.54|TWO_SIDED|95.0|0.57|2.96|||Fisher Exact|||||2.96|.57|0.54
71859937|NCT00458393|143234153|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.5|TWO_SIDED|95.0|0.65|1.23|||Log Rank|||||1.23|0.65|0.50
71859938|NCT00458393|143234154|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.92|TWO_SIDED|95.0|0.79|1.23|||Log Rank|||||1.23|0.79|0.92
71859939|NCT00458393|143234155|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Null hypothesis of no difference||||1.00
71859940|NCT00458393|143234155|SUPERIORITY|Desc|Risk Difference (RD)|0.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
71859941|NCT00458393|143234156|SUPERIORITY||Mean Difference (Net)|-0.91||||0.001|TWO_SIDED|||||\< 0.05 for statistical significance. no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.001
71859942|NCT00458393|143234157|SUPERIORITY||Median Difference (Net)|-3.8||||0.009|TWO_SIDED|95.0|-6.6|-0.95|||median regression|||||-0.95|-6.6|0.009
71859943|NCT00458393|143234158|SUPERIORITY||Median Difference (Net)|0.0||||1|TWO_SIDED|95.0|-9.3|9.3|||median regression|||||9.3|-9.3|1.00
71859944|NCT00458393|143234159|SUPERIORITY||Median Difference (Net)|-2.2||||0.19|TWO_SIDED|95.0|-5.5|1.1|||median regression|||||1.1|-5.5|0.19
71859945|NCT00458393|143234160|SUPERIORITY||Mean Difference (Net)|0.08||||0.56|TWO_SIDED|95.0|-0.18|0.33|||t-test, 2 sided|||||0.33|-.18|0.56
71922011|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.7|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-5.3|6.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose AM||6.6|-5.3|
71681345|NCT00772005|142881211|SUPERIORITY_OR_OTHER|||||||0.4022||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4022
71681346|NCT00772005|142881211|SUPERIORITY_OR_OTHER|||||||0.6246||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6246
71859946|NCT00458393|143234161|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||Null hypothesis is the proportion of mutations is identical.|Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/|||1.00
71859947|NCT00458393|143234162|SUPERIORITY||Mean Difference (Net)|-7.0||||0.32|TWO_SIDED|95.0|-69.0|54.0|||Mixed Models Analysis|||||54|-69|0.32
71859948|NCT00458393|143234163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.005||||0.53|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis|||Null hypothesis is equal proportion of pills returned||0.01|-0.02|0.53
71859949|NCT00458393|143234164|SUPERIORITY||Mean Difference (Net)|0.25||||0.7|TWO_SIDED|95.0|-1.1|1.6|||t-test, 2 sided||||Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/|1.6|-1.1|0.70
71859950|NCT00458393|143234165|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|||||Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.99
71859951|NCT00458393|143234166|SUPERIORITY||Median Difference (Final Values)|0.0||||0.76|TWO_SIDED|95.0|-0.42|0.42||Not adjusted for multiple comparisons, a priori threshold for statistical significance, p \< 0.05|Wilcoxon (Mann-Whitney)||||Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497|.42|-.42|0.76
71859952|NCT00458393|143234167|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.008||||0.68|TWO_SIDED|95.0|-0.047|0.03|||Chi-squared|||Null is no difference between arms||0.030|-0.047|0.68
71859953|NCT00458393|143234168|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.3|TWO_SIDED|95.0|0.89|1.43|||Log Rank|||Null hypothesis of no difference between the arms||1.43|0.89|0.30
71859954|NCT00458393|143234169|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.41|TWO_SIDED|95.0|0.8|1.7|||Log Rank||||Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/|1.7|0.8|0.41
71859955|NCT00458393|143234170|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.09|TWO_SIDED|95.0|0.34|1.09|||Log Rank|||||1.09|0.34|0.09
71859956|NCT01587118|143234179|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||<.0001
71859957|NCT01587118|143234180|SUPERIORITY_OR_OTHER|||||||0.0006||||||The a priori threshold for statistical significance was p\</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.||||||.0006
71859958|NCT00537329|143234182|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.1||||||95.0|70.5|95.3||||||Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.||95.3|70.5|
71859959|NCT00537329|143234183|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.2||||||95.0|74.6|97.0||||||EOIT||97.0|74.6|
71859960|NCT00537329|143234183|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|82.8||||||95.0|64.2|94.2||||||2 Wks post EOT||94.2|64.2|
71859961|NCT00537329|143234183|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|89.5||||||95.0|66.9|98.7||||||6 Wks post EOT||98.7|66.9|
71859962|NCT00537329|143234183|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.7||||||95.0|49.8|89.3||||||12 Wks post baseline||89.3|49.8|
71859963|NCT00537329|143234184|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOIT: success (cure/improvement)||99.9|85.1|
71859964|NCT00537329|143234184|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.1||||||95.0|80.3|99.3||||||EOT: success (cure/improvement)||99.3|80.3|
71859965|NCT00537329|143234184|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|92.9||||||95.0|76.5|99.1||||||2 Wks post EOT: success (cure/improvement)||99.1|76.5|
71859966|NCT00537329|143234184|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (cure/improvement)||99.9|72.7|
71859967|NCT00537329|143234184|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|85.0||||||95.0|62.1|96.8||||||12 Wks post baseline: success (cure/improvement)||96.8|62.1|
71859968|NCT00537329|143234185|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.3||||||95.0|85.8|99.9||||||EOIT: success (erad/presumed erad)||99.9|85.8|
71859969|NCT00537329|143234185|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOT: success (erad/presumed erad)||99.9|85.1|
71859970|NCT00537329|143234185|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|86.2||||||95.0|68.3|96.1||||||2 Wks post EOT: success (erad/presumed erad)||96.1|68.3|
71859971|NCT00537329|143234185|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (erad/presumed erad)||99.9|72.7|
71859972|NCT00537329|143234185|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.2||||||95.0|60.4|96.6||||||12 Wks post baseline: success (erad/presumed erad)||96.6|60.4|
71859973|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|50.0||||||95.0|1.3|98.7||||||Neutropenic status: ANC ≤ 500/cmm||98.7|1.3|
71859974|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|75.7||||||95.0|58.8|88.2||||||Neutropenic status: ANC \> 500/cmm||88.2|58.8|
71859975|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|41.9|91.6||||||Baseline pathogen: Candida albicans||91.6|41.9|
71859976|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|66.7||||||95.0|22.3|95.7||||||Baseline pathogen: Candida glabrata||95.7|22.3|
71922012|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.5|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-8.1|13.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||13.2|-8.1|
71859977|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|39.8|100.0||||||Baseline pathogen: Candida parapsilosis||100.0|39.8|
71859978|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|2.5|100.0||||||Baseline pathogen: Candida rugosa||100.0|2.5|
71859979|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|72.2||||||95.0|46.5|90.3||||||Baseline pathogen: Candida tropicalis||90.3|46.5|
71859980|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|84.6||||||95.0|54.6|98.1||||||Previous surgery: Any surgery||98.1|54.6|
71859981|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|87.5||||||95.0|47.3|99.7||||||Previous surgery: Abdominal surgery||99.7|47.3|
71859982|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|58.8||||||95.0|32.9|81.6||||||Elderly: Age ≥ 65 years||81.6|32.9|
71859983|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|54.5||||||95.0|23.4|83.3||||||Renal insufficiency (CCC \< 30 mL/min)||83.3|23.4|
71859984|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|81.0||||||95.0|58.1|94.6||||||Use of Central venous catheter = Yes||94.6|58.1|
71859985|NCT00537329|143234192|SUPERIORITY_OR_OTHER||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|29.0|96.3||||||Receiving chemotherapy = Yes||96.3|29.0|
71859986|NCT02138253|143234205|SUPERIORITY|For the primary efficacy analysis based on the Month 24 biopsy, subjects with a missing Month 24 biopsy had their Ishak fibrosis score imputed. Imputation of missing Ishak fibrosis scores was conducted using multiple imputation (MI). Results were imputed based on age, gender, baseline Ishak fibrosis score, and the Month 12 Ishak fibrosis score.|Risk Difference (RD)|2.9||||0.73|TWO_SIDED|95.0|-20.5|26.4||Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).|Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||26.4|-20.5|0.73
71859987|NCT02138253|143234206|SUPERIORITY||Risk Difference (RD)|4.4||||0.658|TWO_SIDED|95.0|-20.0|28.9|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||28.9|-20.0|0.658
71859988|NCT02138253|143234207|SUPERIORITY||Risk Difference (RD)|-7.9||||0.421|TWO_SIDED|95.0|-28.8|13.1|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.||13.1|-28.8|0.421
71859989|NCT02725528|143234237|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859990|NCT02725528|143234238|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71681347|NCT00772005|142881211|SUPERIORITY_OR_OTHER|||||||0.8655||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8655
71681348|NCT00772005|142881212|SUPERIORITY_OR_OTHER|||||||0.5676||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5676
71859991|NCT02725528|143234239|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859992|NCT02725528|143234240|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859993|NCT02725528|143234241|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859994|NCT02725528|143234242|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859995|NCT02725528|143234243|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859996|NCT02725528|143234244|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859997|NCT02725528|143234245|SUPERIORITY|||||||0.05|||||||ANCOVA|||Between groups analysis for PROMs, QALYs and ROM at 12-months were determined using one-way analysis of covariance (ANCOVA). Group was entered as the independent variable, the 12-month outcome of interest was entered as the dependent variable and the baseline value for the corresponding outcome measure was entered as the covariate. Statistical significance was considered at p \< .05; all analyses were performed using SPSS® version 26.0||||0.05
71859998|NCT03432390|143234329|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.0001
71859999|NCT00763451|143234370|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.583|-0.232||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.232|-0.583|<0.0001
71860000|NCT00763451|143234370|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.317||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0,\>=8.0%) and screening BMI (\<30,\>=30 kg/m\^2), country as fixed effects, baseline HbA1c as covariate."||-0.317|-0.670|<0.0001
71860001|NCT00087555|143234386|SUPERIORITY_OR_OTHER|||||||0.052||95.0|||||Chi-squared|||||||0.052
71922013|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-6.3|15.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 1 hour||15.0|-6.3|
71860002|NCT00087555|143234386|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Chi-squared|||||||0.024
71860003|NCT00087555|143234386|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||||||0.035
71860004|NCT02554383|143234407|SUPERIORITY|||||||0.02||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (2).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of pathogens in the nasopharynx at enrollment, i.e., there is no significant interaction between treatment and pathogens in the nasopharynx.||||0.02
71681349|NCT00772005|142881212|SUPERIORITY_OR_OTHER|||||||0.5239||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5239
71681350|NCT00772005|142881212|SUPERIORITY_OR_OTHER|||||||0.4092||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4092
71681351|NCT00772005|142881213|SUPERIORITY_OR_OTHER|||||||0.5195||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5195
71860005|NCT02554383|143234407|SUPERIORITY||Difference of least-squares means|-1.95|||||TWO_SIDED|95.0|-2.4|-1.51|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of one or more pathogens in the nasopharynx at enrollment.||-1.51|-2.40|
71860006|NCT02554383|143234407|SUPERIORITY||Difference of least-squares means|-0.88|||||TWO_SIDED|95.0|-1.63|-0.12|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of one or more pathogens in the nasopharynx at enrollment.||-0.12|-1.63|
71860007|NCT02554383|143234408|SUPERIORITY|||||||0.37||||||The interactions (1) between treatment \& pathogens and (2) between treatment \& colored nasal discharge are tested simultaneously.|Mixed Models Analysis|The p value is adjusted for PRSS score at enrollment, diary day, study site, treatment, pathogens, colored nasal discharge \& interaction (1).||Null hypothesis: The effect of treatment with antibiotics does not differ in the subgroups of children defined, respectively, by the presence and by the absence of colored nasal discharge at enrollment, i.e., there is no significant interaction between treatment and colored nasal discharge.||||0.37
71860008|NCT02554383|143234408|SUPERIORITY||Difference of least-squares means|-1.62|||||TWO_SIDED|95.0|-2.09|-1.16|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the presence of colored nasal discharge at enrollment.||-1.16|-2.09|
71860009|NCT02554383|143234408|SUPERIORITY||Difference of least-squares means|-1.7|||||TWO_SIDED|95.0|-2.38|-1.03|||||The Amoxicillin-clavulanate group represents the first number in the subtraction and the Placebo group represents the second. The estimates are adjusted for PRSS score at enrollment, diary day and study site.|Null hypothesis: There is no difference between the treatment groups in the subgroup of children defined by the absence of colored nasal discharge at enrollment.||-1.03|-2.38|
71860010|NCT02554383|143234409|SUPERIORITY|||||||0.003|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children experiencing treatment failure.||||0.003
71860011|NCT02554383|143234410|SUPERIORITY|||||||0.007|||||||Fisher Exact|||Null hypothesis: There is no difference between the treatment groups in the proportion of children developing AOM over the first 10 days of follow-up.||||.007
71860012|NCT02554383|143234411|SUPERIORITY||||||<|0.001|||||||Log-binomial regression|The p-value is adjusted for study site and and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children receiving a systemic antibiotic over the first 10 days of follow-up.||||<0.001
71860013|NCT02554383|143234412|SUPERIORITY|||||||0.004|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children for whom diarrhea or generalized rash was reported.||||0.004
71860014|NCT02554383|143234413|SUPERIORITY|||||||0.75|||||||Log-binomial regression|The p-value is adjusted for presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children compliant with study product.||||0.75
71922014|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||11.2|-4.6|
71681352|NCT00772005|142881213|SUPERIORITY_OR_OTHER|||||||0.1732||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1732
71860015|NCT02554383|143234414|SUPERIORITY|||||||0.63|||||||Log-binomial regression|The p-value is adjusted for study site and presence of colored nasal discharge.||Null hypothesis: There is no difference between the treatment groups in the proportion of children with a nonsusceptible pathogen at the follow-up visit.||||0.63
71860016|NCT01185171|143234450|NON_INFERIORITY|The power of the study was conducted as a two-stage, non-inferiority phase II trial with a total sample size of 59 patients to detect a 15% lower rate than 80% achieved with TFHX, with alpha = 0.05 and beta = 0.20. In the first stage, 25 patients were recruited, with a plan to terminate if 16 or less complete responses (CR) were observed. Otherwise, additional 34 patients would be recruited and the treatment would be deemed not inferior to historical if more than 45 CRs were observed.|proportion|0.88|||<|0.01|TWO_SIDED|95.0|0.77|0.95||Ho: CR rate = 0.65 vs Ha: CR rate \> 0.65|Binomial test for a proportion|||||0.95|0.77|< 0.01
71860017|NCT00727506|143234455|SUPERIORITY_OR_OTHER|||||||0.148||95.0||||P-value is from an approximate normal test for the 6 month time point.|z-test|||||||0.148
71860018|NCT00727506|143234455|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value is an approximate normal test for the six month time point.|z-test|||||||0.008
71860019|NCT00727506|143234457|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0000
71860020|NCT00727506|143234457|SUPERIORITY_OR_OTHER|||||||0.1954||95.0|||||Fisher Exact|||||||0.1954
71860021|NCT00727506|143234458|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.78||||0.032|TWO_SIDED|95.0|1.088|2.912|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline Karnofsky Performance Scale (KPS) score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.912|1.088|0.0320
71860022|NCT00727506|143234458|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.392||||0.2044|TWO_SIDED|95.0|0.841|2.301|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (\<=50 vs. \>50 years old) and baseline KPS score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.||2.301|0.841|0.2044
71860023|NCT02647645|143234607|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.02||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = 1.78).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.||||0.02
71860024|NCT02647645|143234608|SUPERIORITY|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.34||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .71).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.34
71860025|NCT02647645|143234609|SUPERIORITY|Power calculation was based on the investigators' estimate of the impact of cognitive training with transcranial direct current stimulation (tDCS) on subjective cognitive problems, as similar studies were not available to develop effect size estimates.||||||0.33||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .63).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.||||0.33
71860026|NCT00356811|143234610|SUPERIORITY_OR_OTHER||percentage of participants|50.9|||||TWO_SIDED|95.0|37.3|64.4|||||The estimated value represents the percentage of participants with a confirmed CR or PR.|||64.4|37.3|
71860027|NCT02007200|143234679|SUPERIORITY_OR_OTHER||||||<|0.005|||||||Linear Repeated Measures Model|||||||<0.005
71860028|NCT04182113|143234687|SUPERIORITY||Mean Difference (Net)|-0.042||||0.32|TWO_SIDED|95.0|-0.129|0.044||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing Target vs. Foil activity following 1Hz rTMS to Target vs. Foil activity following 20 Hz rTMS stimulation.||0.044|-0.129|0.32
71681353|NCT00772005|142881213|SUPERIORITY_OR_OTHER|||||||0.7455||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7455
71860029|NCT04182113|143234687|SUPERIORITY||Mean Difference (Net)|0.043||||0.25|TWO_SIDED|95.0|-0.03|0.12||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activation following 1 Hz rTMS and Target vs. Foil activation following Sham stimulation..||0.12|-0.03|0.25
71860030|NCT04182113|143234687|SUPERIORITY||Mean Difference (Net)|0.078||||0.13|TWO_SIDED|95.0|-0.024|0.181||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test between Target vs. Foil activity following 20 Hz rTMS and Target vs. Foil activity following Sham stimulation.||0.181|-0.024|0.13
71860031|NCT04182113|143234688|SUPERIORITY||Mean Difference (Net)|0.018||||0.038|TWO_SIDED|95.0|0.001|0.034||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.034|0.001|0.038
71860032|NCT04182113|143234688|SUPERIORITY||Mean Difference (Net)|0.009||||0.44|TWO_SIDED|95.0|-0.015|0.033|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 1Hz rTMS to precuneus connectivity following 20 Hz rTMS stimulation.||0.033|-0.015|0.44
71860033|NCT04182113|143234688|SUPERIORITY||Mean Difference (Net)|-0.012||||0.25|TWO_SIDED|95.0|-0.032|0.009|||t-test, 2 sided|||Paired t-test comparing precuneus connectivity following 20Hz rTMS to precuneus connectivity following sham stimulation.||0.009|-0.032|0.25
71860034|NCT04182113|143234689|SUPERIORITY||Mean Difference (Net)|2.7||||0.2|TWO_SIDED|95.0|-1.6|6.9||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following 20 Hz rTMS.||6.9|-1.6|0.20
71860035|NCT04182113|143234689|SUPERIORITY||Mean Difference (Net)|4.0||||0.17|TWO_SIDED|95.0|-1.9|9.9||Not corrected for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 1Hz rTMS to accuracy following sham rTMS.||9.9|-1.9|0.17
71860036|NCT04182113|143234689|SUPERIORITY||Mean Difference (Net)|-1.3||||0.77|TWO_SIDED|95.0|-10.8|8.2||Not adjusted for multiple comparisons.|t-test, 2 sided|||Paired t-test of scene recognition performance accuracy following 20Hz rTMS to accuracy following 20 Hz rTMS.||8.2|-10.8|0.77
71860037|NCT01667406|143234690|OTHER|Fishers exact conditional test was used to confirm significance|Mean Difference (Final Values)|6.0|||||ONE_SIDED|95.0||||||||Data presented using descriptive statistics. Confidence intervals were derived for the difference between the means of different doses.||||
71860038|NCT01667406|143234690|OTHER||||||<|0.05|||||||Fisher Exact|||Phase 2||||<0.05
71860039|NCT01667406|143234690|OTHER||Odds Ratio (OR)|0.05|||<|0.05|ONE_SIDED|95.0|||||Regression, Logistic||Estimate of difference in success rates and estimate of odds ratio for success were derived, with P value comparing 2 treatment groups, 95% conﬁdence intervals.|Phase 3||||<0.05
71860040|NCT01667406|143234691|OTHER|secondary outcomes were analysed using descriptive statistics.||||||||||||||||Study data were summarised using standard descriptive methods. Continuous variables following a normal distribution have been summarised using mean and SD.|secondary outcomes were analysed using descriptive statistics.|||
71860041|NCT02768597|143234696|SUPERIORITY|||||||0.552|||||||ANOVA|||||||.552
71681354|NCT00772005|142881214|SUPERIORITY_OR_OTHER|||||||0.6885||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6885
71860042|NCT02768597|143234697|SUPERIORITY|||||||0.558|||||||ANOVA|||||||.558
71906843|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.5664||95.0|-0.45|0.82||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.82|-0.45|0.5664
71906844|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.6871||95.0|-0.55|0.37||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.37|-0.55|0.6871
71681355|NCT00772005|142881214|SUPERIORITY_OR_OTHER|||||||0.5443||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5443
71860043|NCT02768597|143234698|SUPERIORITY|||||||0.274|||||||Kruskal-Wallis|||||||.274
71860044|NCT02768597|143234699|SUPERIORITY|||||||0.539|||||||Kruskal-Wallis|||||||.539
71860045|NCT02768597|143234700|SUPERIORITY|||||||0.478|||||||Kruskal-Wallis|||||||.478
71860046|NCT02768597|143234701|SUPERIORITY|||||||0.527|||||||ANOVA|||||||.527
71906845|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.2318||95.0|-1.08|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.08|0.2318
71906846|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3383||95.0|-0.64|0.22||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.22|-0.64|0.3383
71681356|NCT00772005|142881214|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9343
71860047|NCT02768597|143234702|SUPERIORITY|||||||0.823|||||||ANOVA|||||||.823
71860048|NCT02768597|143234703|SUPERIORITY|||||||0.231|||||||ANOVA|||||||.231
71860049|NCT02768597|143234704|SUPERIORITY|||||||0.595|||||||Kruskal-Wallis|||||||.595
71860050|NCT02768597|143234705|SUPERIORITY|||||||0.789|||||||Kruskal-Wallis|||||||.789
71860051|NCT02229578|143234706|SUPERIORITY||Mean Difference (Final Values)|0.45|||<|0.05|TWO_SIDED|95.0|-1.2|2.1|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||2.1|-1.2|<0.05
71860052|NCT02229578|143234707|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.79|<|0.05|TWO_SIDED|95.0|-1.77|1.49|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.||1.49|-1.77|<0.05
71860053|NCT02229578|143234708|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|3.61|<|0.05|TWO_SIDED|95.0|-9.62|6.09|||t-test, 2 sided|||Outcome was residual change score calculated by regressing immediate postop hydromorphone on 24 hour hydromorphone. This allows patient to serve as own control for intial values.||6.09|-9.62|<0.05
71860054|NCT01015677|143234726|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.28||||0.488|TWO_SIDED|95.0|-24.2|11.64|||Longitudinal Data Analysis (LDA)|LDA model terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||11.64|-24.20|0.488
71860055|NCT01015677|143234726|SUPERIORITY_OR_OTHER||Difference in the least squares means|-17.45||||0.069|TWO_SIDED|95.0|-36.28|1.38|||Longitudinal Data Analysis|LDA model with terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||1.38|-36.28|0.069
71860056|NCT01015677|143234729|SUPERIORITY_OR_OTHER||Differrence in the least squares means|-6.05||||0.529|TWO_SIDED|95.0|-25.06|12.96|||Longitudinal Data Analysis (LDA)|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||12.96|-25.06|0.529
71860057|NCT01015677|143234729|SUPERIORITY_OR_OTHER||Difference in the least squares means|-11.22||||0.264|TWO_SIDED|95.0|-31.03|8.59|||Longitudinal Data Analysis|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.||||8.59|-31.03|0.264
71906847|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.874||95.0|-0.63|0.73||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.73|-0.63|0.8740
71906848|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.999||95.0|-0.54|0.54||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.54|-0.54|0.9990
71906849|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.4183||95.0|-0.85|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.36|-0.85|0.4183
71906850|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.8227||95.0|-0.71|0.57||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.57|-0.71|0.8227
71906851|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.18||||0.587||95.0|-0.48|0.85||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.85|-0.48|0.5870
71906852|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2181||95.0|-1.15|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.27|-1.15|0.2181
71860058|NCT01015677|143234730|SUPERIORITY_OR_OTHER||Difference in LS means|0.94||||0.827|TWO_SIDED|90.0|-6.19|8.07|||ANCOVA|Analysis of covariance (ANCOVA) with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||8.07|-6.19|0.827
71860059|NCT01015677|143234730|SUPERIORITY_OR_OTHER||Difference in the LS means|-14.52||||0.001|TWO_SIDED|90.0|-21.73|-7.32|||ANCOVA|ANCOVA with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.||||-7.32|-21.73|0.001
71860060|NCT02232399|143234731|OTHER|||||||0.45||||||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.|Mixed Models Analysis|Unstructured covariance pattern was assumed.||To test whether there were any significant differences between the two treatment groups over time (group vs time interaction), a repeated measurement mixed-model approach was used. This assumed an unstructured covariance pattern.||||0.45
71860061|NCT02232399|143234732|OTHER|||||||0.7|||||||Regression, Logistic|||||||0.70
71681357|NCT00772005|142881215|SUPERIORITY_OR_OTHER|||||||0.9093||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9093
71860062|NCT01646385|143234739|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.836||||0.084|TWO_SIDED|95.0|0.683|1.025|||Regression, Cox|||Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis.||1.025|0.683|0.084
71860063|NCT01646385|143234740|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.512||||0.035|TWO_SIDED|95.0|0.276|0.952|||Regression, Cox|||Cox proportional hazards model adjusted for age was used for analysis.||0.952|0.276|0.035
71860064|NCT01646385|143234741|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.019||||0.855|TWO_SIDED|95.0|0.831|1.251|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, baseline DMARDs, methotrexate, disease activity score based on 28-joints count (DAS28), and smoking history was used for analysis.||1.251|0.831|0.855
71860065|NCT01646385|143234742|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.564|0.87|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, and baseline health assessment questionnaire (HAQ) score was used for analysis.||0.870|0.564|0.001
71906853|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.6276||95.0|-0.68|0.42||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.42|-0.68|0.6276
71681358|NCT00772005|142881215|SUPERIORITY_OR_OTHER|||||||0.4701||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4701
71681359|NCT00772005|142881215|SUPERIORITY_OR_OTHER|||||||0.9764||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9764
71860066|NCT01646385|143234743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717||||0.024|TWO_SIDED|95.0|0.537|0.958|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, baseline HAQ score, Charlson index, smoking history, and body mass index was used for analysis.||0.958|0.537|0.024
71860067|NCT01646385|143234746|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71860068|NCT01646385|143234747|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with Analysis of Covariance (ANCOVA) using the General Linear Model (GLM) method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
71860069|NCT01646385|143234747|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
71860070|NCT01646385|143234747|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
71681360|NCT00772005|142881216|SUPERIORITY_OR_OTHER|||||||0.8115||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8115
71860071|NCT01646385|143234747|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||Change at Year 4: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.0001
71860072|NCT01646385|143234747|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANCOVA|||Change at Year 5: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||0.01
71860073|NCT01646385|143234750|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71860074|NCT01646385|143234751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 1: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
71860075|NCT01646385|143234751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
71860076|NCT01646385|143234751|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.||||<0.001
71860077|NCT02818998|143234777|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.01|||<|0.0001|TWO_SIDED|95.0|-1.46|1.47||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.47|-1.46|<0.0001
71860078|NCT02818998|143234777|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|0.95|||<|0.0001|TWO_SIDED|95.0|-0.52|2.42||Non-inferiority was demonstrated if the p-value (adjusted for multiplicity using the Hochberg procedure) was \< 0.025|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||2.42|-0.52|<0.0001
71860079|NCT02818998|143234778|OTHER||Least Square mean difference|14.38||||0.0105|TWO_SIDED|95.0|3.39|25.37|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||25.37|3.39|0.0105
71681361|NCT00772005|142881216|SUPERIORITY_OR_OTHER|||||||0.5378||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5378
71906854|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57||||0.0917||95.0|-1.23|0.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.09|-1.23|0.0917
71906855|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2089||95.0|-1.13|0.25||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.25|-1.13|0.2089
71906856|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4188||95.0|-0.75|0.31||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.31|-0.75|0.4188
71906857|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.6959||95.0|-0.32|0.21||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.21|-0.32|0.6959
71906858|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.4806||95.0|-0.64|0.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.30|-0.64|0.4806
71681362|NCT00772005|142881216|SUPERIORITY_OR_OTHER|||||||0.9144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9144
71681363|NCT00772005|142881217|SUPERIORITY_OR_OTHER|||||||0.9812||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9812
71681364|NCT00772005|142881217|SUPERIORITY_OR_OTHER|||||||0.5464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5464
71922015|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-1.0|14.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose AM 4 hour||14.9|-1.0|
71681365|NCT00772005|142881217|SUPERIORITY_OR_OTHER|||||||0.8811||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8811
71681366|NCT00772005|142881218|SUPERIORITY_OR_OTHER|||||||0.6487||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6487
71681367|NCT00772005|142881218|SUPERIORITY_OR_OTHER|||||||0.4204||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4204
71681368|NCT00772005|142881218|SUPERIORITY_OR_OTHER|||||||0.6955||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6955
71906859|NCT00589979|143335697|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.2291||95.0|-0.74|0.18||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.18|-0.74|0.2291
71906860|NCT00589979|143335698|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.3185||95.0|0.77|2.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.27|0.77|0.3185
71906861|NCT00589979|143335699|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.4748||95.0|0.72|2.06||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||2.06|0.72|0.4748
71681369|NCT00772005|142881219|SUPERIORITY_OR_OTHER|||||||0.6042||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6042
71681370|NCT00772005|142881219|SUPERIORITY_OR_OTHER|||||||0.9783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9783
71860080|NCT02818998|143234778|OTHER||Least Square mean difference|21.22||||0.0023|TWO_SIDED|95.0|7.65|34.8|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||34.80|7.65|0.0023
71860081|NCT02818998|143234779|OTHER||Treatment Difference|0.68|||||TWO_SIDED|95.0|-3.14|4.49|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.49|-3.14|
71860082|NCT02818998|143234779|OTHER||Treatment Difference|2.66|||||TWO_SIDED|95.0|-3.4|8.73|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||8.73|-3.40|
71860083|NCT02818998|143234779|OTHER||Treatment Difference|-0.66|||||TWO_SIDED|95.0|-1.94|0.63|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.63|-1.94|
71860084|NCT02818998|143234779|OTHER||Treatment Difference|-0.13|||||TWO_SIDED|95.0|-3.68|3.41|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||3.41|-3.68|
71860085|NCT02818998|143234779|OTHER||Treatment Difference|1.72|||||TWO_SIDED|95.0|-4.1|7.54|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||7.54|-4.10|
71860086|NCT02818998|143234779|OTHER||Treatment Difference|-0.68|||||TWO_SIDED|95.0|-2.0|0.65|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||0.65|-2.00|
71922016|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
71922017|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|3.5|||TWO_SIDED|95.0|-8.5|5.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, pre-dose PM||5.9|-8.5|
71860087|NCT02818998|143234780|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-2.13|1.52|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||1.52|-2.13|<0.0001
71860088|NCT02818998|143234780|NON_INFERIORITY|Non-inferiority margin: 4 letters|Least Squares mean difference|1.39|||<|0.0001|TWO_SIDED|95.0|-0.4|3.19|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||3.19|-0.40|<0.0001
71860089|NCT02818998|143234781|OTHER||Least Square mean difference|16.14||||0.0416|TWO_SIDED|95.0|0.62|31.66|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||31.66|0.62|0.0416
71860090|NCT02818998|143234781|OTHER||Least Square mean difference|4.12||||0.5524|TWO_SIDED|95.0|-9.52|17.77|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm||17.77|-9.52|0.5524
71860091|NCT02818998|143234782|OTHER||Treatment Difference|0.67|||||TWO_SIDED|95.0|-2.72|4.05|||Cochran-Mantel-Haenszel|||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||4.05|-2.72|
71860092|NCT02818998|143234782|OTHER||Treatment Difference|4.63|||||TWO_SIDED|95.0|-1.73|10.98|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||10.98|-1.73|
71860093|NCT02818998|143234782|OTHER||Treatment Difference|0.66|||||TWO_SIDED|95.0|-1.56|2.87|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.87|-1.56|
71860094|NCT02818998|143234782|OTHER||Treatment Difference|1.9|||||TWO_SIDED|95.0|-1.89|5.69|||Cochran-Mantel-Haenszel|||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||5.69|-1.89|
71860095|NCT02818998|143234782|OTHER||Treatment Difference|7.54|||||TWO_SIDED|95.0|0.81|14.28|||Cochran-Mantel-Haenszel|||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm||14.28|0.81|
71860096|NCT02818998|143234782|OTHER||Treatment Difference|0.63|||||TWO_SIDED|95.0|-1.61|2.88|||Cochran-Mantel-Haenszel|||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm||2.88|-1.61|
71906862|NCT00589979|143335700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.7839||95.0|-0.74|0.98||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.98|-0.74|0.7839
71906863|NCT00589979|143335702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.3773||95.0|-0.02|0.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||0.04|-0.02|0.3773
71906864|NCT00589979|143335703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.2605||95.0|0.38|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.38|0.2605
71906865|NCT00589979|143335704|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.3193||95.0|0.44|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.||1.30|0.44|0.3193
71922018|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.2|9.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.5|-9.2|
71681371|NCT00772005|142881219|SUPERIORITY_OR_OTHER|||||||0.9739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9739
71860097|NCT05043883|143234798|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome specificity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage (%)|87.0||||0.006|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the specificity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Specificity is the ability to correctly detect true negative values of the ground-truth negative EGM classifications. The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that specificity is lower or equal to the superiority limit 80%.||||0.006
71860098|NCT05043883|143234798|SUPERIORITY|This clinical investigation is intended to demonstrate that the performance of the PVI Analyzer software is superior to clinically relevant performance level, and therefore the study is designed as a 1-sample superiority test of the sampled outcome Sensitivity. The lower bound 95% CI (α=0.05) and at a statistical power of 95% (β=0.05).|Percentage|86.0||||0.004|ONE_SIDED|95.0||||The success of the PVI Analyzer output was assumed to follow a binominal distribution with a given true proportion of 87.50%. It was tested whether the sensitivity was superior to the 80% limit.|Z-test|A one-tailed test with a significance level of 95% (α = 0.05) was applied.||Sensitivity of the PVI analyzer is determined by the capability to detect true positive among all ground-truth positive EGM classifications.The PVI Analyzer software classifies an EGM in positive (isolated) or negative (non-isolated), compared to the SOC outcomes. EGMs prior-isolation were labeled as ground-truth negative (non-isolated), EGMs after isolation as ground-truth positive (isolated). The null hypothesis is that sensitivity is lower or equal to the superiority limit 80%.||||0.004
71860099|NCT05043883|143234799|OTHER|Descriptive|Percentage|0.99|STANDARD_DEVIATION|0.1|||TWO_SIDED|95.0|0.02|5.39|||||Only one AE was reported for one subject ( which was considered moderate in severity and not related to the device, but related to the SOC procedure.|A descriptive analysis was performed to evaluate the AEs and device deficiencies, estimating the percentages and 95% CI on each category.||5.39|0.02|
71860100|NCT05043883|143234800|SUPERIORITY||Percentage (%)|94.0||||2e-05|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.00002
71860101|NCT05043883|143234800|SUPERIORITY||Percentage (%)|82.0||||0.32|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Radiofrequency procedure from EP procedure until study completion at discharge (an average of 24 hours), with sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.32
71681372|NCT00772005|142881220|SUPERIORITY_OR_OTHER|||||||0.3466||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3466
71922019|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.5|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 1 hour||9.2|-9.5|
71860102|NCT05043883|143234800|SUPERIORITY||Percentage (%)|79.0||||0.66|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that specificity is below 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a specificity superior to 80%. A superiority Z-test for Specificity was performed.||||0.66
71860103|NCT05043883|143234800|SUPERIORITY||Percentage (%)|92.0||||0.0008|TWO_SIDED|||||Computed p values are the result of running a one sample z-test with a null hypothesis that sensitivity is below 80% and alternative hypothesis that sensitivity is at or above 80%.|Z-test|||Automated PVI Analyzer classification of PV isolation in SR by Cryo-balloon procedure from EP procedure until study completion at discharge (an average of 24 hours), with a sensitivity superior to 80%. A superiority Z-test for Sensitivity was performed.||||0.0008
71860104|NCT05043883|143234801|SUPERIORITY||Percentage (%)|96.0||||5e-06|TWO_SIDED|||||To compute the proportional agreement between two non-overlapping samples, a one-sample Z-test was performed with the alternative hypothesis that agreement was above 90%, which was considered sufficient for a real-time assessment.|Z-test|||This endpoint used the same EGMs extracted for the primary endpoint, including only EGMs from T Baseline and T Final measurements from patients in sinus rhythm.||||0.000005
71860105|NCT05043883|143234802|SUPERIORITY||Percentage (%)|54.0||||1|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the specificity are below 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||1
71860106|NCT05043883|143234802|SUPERIORITY||Percentage (%)|100.0||||0.0007|TWO_SIDED|||||The p values calculated are the result of running a one sample z-test with a null hypothesis that the sensitivity are below 80% and an alternative hypothesis that sensitivity is at or above 80%.|Z-test|||The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.||||0.0007
71860107|NCT05043883|143234803|SUPERIORITY||Percentage (%)|87.0||||0.04|TWO_SIDED||||||Z-test|The estimate was done using a one-sample Z-test with a null hypothesis that sensitivity is at or below 80% and a 95% significance level.||This secondary endpoint aimed to determine the sensitivity of the PVI Analyzer at the time of isolation, which requires the EGMs at the T PVI. A Z-test for sensitivity was performed to assess the sensitivity of the PVI Analyzer analysis to identify expert-defined isolation during the PVI ablation.||||0.04
71860108|NCT05043883|143234804|OTHER|||||||0.0002||||||McNemar test assumes as a null hypothesis that the two datasets cause the PVI Analyzer to have a similar proportion of errors.|McNemars test|A paired McNemars test with an alpha value of 0.05, was applied to analyze the differences in classification performance.||A paired McNemar's Chi-Square test was performed to analyze the differences in classification performances||||0.0002
71860109|NCT01586975|143234811|SUPERIORITY_OR_OTHER|||||||0.0742|TWO_SIDED|||||p-value is not adjusted, and no a priori threshold was used|Kruskal-Wallis|||Kruskal-Wallis non-parametric ANOVA test||||0.0742
71860110|NCT01390441|143234831|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|0.87|1.16|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.16|0.87|
71860111|NCT01390441|143234833|SUPERIORITY_OR_OTHER||Percent difference|-17.2|||||TWO_SIDED|95.0|-38.6|3.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m\^2 - Part A: MabThera 500 mg/m\^2) when \>=4 participants in an arm experienced an event.||3.6|-38.6|
71860112|NCT01390441|143234833|SUPERIORITY_OR_OTHER||Percent difference|-17.5|||||TWO_SIDED|95.0|-44.4|10.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when \>=4 participants in an arm experienced an event.||10.9|-44.4|
71860113|NCT01390441|143234833|SUPERIORITY_OR_OTHER||Percent difference|-5.6|||||TWO_SIDED|95.0|-34.9|24.6|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||24.6|-34.9|
71860114|NCT01390441|143234833|SUPERIORITY_OR_OTHER||Percent differnce|12.0|||||TWO_SIDED|95.0|-15.6|38.9|||Miettinen-Nurminen|||The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when \>=4 participants in an arm experienced an event.||38.9|-15.6|
71860115|NCT01390441|143234835|NON_INFERIORITY_OR_EQUIVALENCE|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.87|1.1|||ANOVA|||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.||1.1|0.87|
71860116|NCT01390441|143234839|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 6 weeks.||0.5|-0.9|
71860117|NCT01390441|143234839|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.4|1.2|||ANCOVA|The model included a term for treatment.||Estimated difference vs MabThera® at 12 weeks.||1.2|-0.4|
71906866|NCT00589979|143335705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.1378||95.0|-0.57|4.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates||4.04|-0.57|0.1378
71906867|NCT00589979|143335706|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.6833||95.0|0.47|1.65||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Logistic|An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|||1.65|0.47|0.6833
71906868|NCT00589979|143335707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.16||||0.1143||95.0|-5.48|49.8||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||49.8|-5.48|0.1143
71906869|NCT00589979|143335707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.9108||95.0|-19.8|22.2||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||22.2|-19.8|0.9108
71906870|NCT00589979|143335707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.31||||0.3769||95.0|-10.3|27.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.||27.0|-10.3|0.3769
71906871|NCT00302718|143335723|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71906872|NCT00302718|143335725|OTHER|||||||0.2114|||||||Chi-squared|||||||0.2114
71906873|NCT00302718|143335727|OTHER|||||||0.6954|||||||Chi-squared|||||||0.6954
71906874|NCT00302718|143335729|OTHER|||||||0.9895|||||||Chi-squared|||||||0.9895
71906875|NCT00383721|143335745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71906876|NCT00383721|143335745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71906877|NCT00383721|143335746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|||||||0.062
71906878|NCT00383721|143335746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.583|||||||ANCOVA|||||||0.583
71906879|NCT00383721|143335747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||ANCOVA|||||||0.020
71906880|NCT00383721|143335747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANCOVA|||||||<0.001
71906881|NCT01146951|143335753|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-26.65||||0.003|TWO_SIDED|90.0|-40.3|-11.8|||Wilcoxon (Mann-Whitney)|||||-11.80|-40.30|0.003
71906882|NCT01146951|143335754|SUPERIORITY_OR_OTHER|||||||0.074|||||||Fisher's exact test|||||||0.074
71906883|NCT01146951|143335755|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-33.3|||<|0.001|TWO_SIDED|90.0|-47.1|-17.0|||Wilcoxon (Mann-Whitney)|||||-17.00|-47.10|<0.001
71906884|NCT01146951|143335756|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-57.15||||0.025|TWO_SIDED|90.0|-104.5|-17.3|||Wilcoxon (Mann-Whitney)|||Analysis for Partial Seizure Frequency||-17.30|-104.50|0.025
71681373|NCT00772005|142881220|SUPERIORITY_OR_OTHER|||||||0.8469||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8469
71860118|NCT02635386|143234842|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measure||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
71860119|NCT02635386|143234843|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860120|NCT02635386|143234844|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860121|NCT02635386|143234845|SUPERIORITY||||||<|0.0001|||||||ANOVA|one way with Bonferroni contrast||One way ANOVA with Bonferroni test to compare differences between groups if significant||||<0.0001
71860122|NCT02635386|143234846|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860123|NCT02635386|143234847|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measure design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
71860124|NCT02635386|143234848|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860125|NCT02635386|143234849|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860126|NCT02635386|143234850|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860127|NCT02635386|143234851|SUPERIORITY||||||<|0.01|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.01
71681374|NCT00772005|142881220|SUPERIORITY_OR_OTHER|||||||0.5439||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5439
71860128|NCT02635386|143234852|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
71860129|NCT02635386|143234853|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860130|NCT02635386|143234854|SUPERIORITY||||||<|0.02|||||||ANOVA|nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.02
71860131|NCT02635386|143234855|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
71860132|NCT02635386|143234856|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860133|NCT02635386|143234857|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
71860134|NCT02635386|143234858|SUPERIORITY||||||>|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||>0.05
71860135|NCT02635386|143234859|SUPERIORITY||||||<|0.04|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.04
71860136|NCT02635386|143234860|SUPERIORITY||||||<|0.0001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.0001
71860137|NCT02635386|143234861|SUPERIORITY||||||<|0.05|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.05
71681375|NCT00772005|142881221|SUPERIORITY_OR_OTHER|||||||0.6059||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6059
71860138|NCT02635386|143234862|SUPERIORITY||||||<|0.001|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.001
71860139|NCT02635386|143234863|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
71860140|NCT02635386|143234864|SUPERIORITY||||||<|0.035|||||||ANOVA|Nested repeated measures design||Repeated Measure general linear model (SS/Drug treatments by visits) including arm of drug treatment as between subjects effect and visit (baseline and post 22-24 weeks treatment) as within subject effect||||<0.035
71860141|NCT02446613|143234865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.41|5.43|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1071.|||5.43|-1.41|
71860142|NCT02446613|143234866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.98|3.75|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2417.|||3.75|-1.98|
71860143|NCT02446613|143234867|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.4|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-1.08|1.87|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2876.|||1.87|-1.08|
71860144|NCT02446613|143234868|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.9|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-1.86|5.34|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1453.|||5.34|-1.86|
71860145|NCT02446613|143234869|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.6|STANDARD_DEVIATION|0.006|||TWO_SIDED|95.0|-10.7|19.71|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2665.|||19.71|-10.70|
71681376|NCT00772005|142881221|SUPERIORITY_OR_OTHER|||||||0.7474||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7474
71860146|NCT02446613|143234870|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.3|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-14.97|24.38|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.3266|||24.38|-14.97|
71860147|NCT02446613|143234871|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.1|STANDARD_DEVIATION|0.008|||TWO_SIDED|95.0|-17.47|19.2|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.4528|||19.20|-17.47|
71860148|NCT02446613|143234872|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.6|STANDARD_DEVIATION|0.007|||TWO_SIDED|95.0|-13.69|28.04|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2525|||28.04|-13.69|
71860149|NCT01062269|143234874|SUPERIORITY_OR_OTHER||||||<|0.05||||||Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p\>0.05),then it was removed from the final model.|measures analysis of variance|Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.||"The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an Importance of Acceptability questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations."||||<0.05
71860150|NCT03178045|143234880|OTHER|Multivariable Logistic Regression|Estimated Increase|0.23|||||TWO_SIDED|95.0|-3.1|3.6||||||||3.6|-3.1|
71860151|NCT03178045|143234881|OTHER|Multivariable logistic regression|Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.69|1.31||||||||1.31|0.69|
71860152|NCT03178045|143234882|OTHER|Longitudinal mixed effects regression|Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.6|1.32||||||||1.32|0.60|
71860153|NCT02706847|143234893|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|36.2|||<|0.001|TWO_SIDED|95.0|26.2|46.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||46.2|26.2|<0.001
71860154|NCT02706847|143234893|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|17.8|38.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.1|17.8|<0.001
71860155|NCT02706847|143234894|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|29.1|||<|0.001|TWO_SIDED|95.0|19.9|38.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||38.3|19.9|<0.001
71860156|NCT02706847|143234894|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.0|37.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||37.4|19.0|<0.001
71860157|NCT02706847|143234895|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.29|||<|0.001|TWO_SIDED|95.0|-1.57|-1.01||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.01|-1.57|<0.001
71860158|NCT02706847|143234895|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.28|||<|0.001|TWO_SIDED|95.0|-1.56|-0.99||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.99|-1.56|<0.001
71860159|NCT02706847|143234896|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.34|-0.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.10|-0.34|<0.001
71860160|NCT02706847|143234896|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.38|-0.13||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.13|-0.38|<0.001
71860161|NCT02706847|143234897|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean DIfference|3.44|||<|0.001|TWO_SIDED|95.0|1.72|5.15||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.15|1.72|<0.001
71906885|NCT01146951|143335756|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-28.65||||0.128|TWO_SIDED|90.0|-72.0|0.9|||Wilcoxon (Mann-Whitney)|||Analysis of atypical absence seizure frequency||0.90|-72.00|0.128
71906886|NCT01146951|143335756|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-54.35||||0.021|TWO_SIDED|90.0|-126.6|-15.4|||Wilcoxon (Mann-Whitney)|||Analysis for myoclonic seizure frequency||-15.40|-126.60|0.021
71906887|NCT01146951|143335756|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-23.2||||0.031|TWO_SIDED|90.0|-40.7|-5.6|||Wilcoxon (Mann-Whitney)|||Analysis of tonic seizure frequency||-5.60|-40.70|0.031
71906888|NCT01146951|143335756|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-71.4||||0.107|TWO_SIDED|90.0|-464.7|30.5|||Wilcoxon (Mann-Whitney)|||Analysis for Tonic-clonic seizure frequency||30.50|-464.70|0.107
71906889|NCT01146951|143335756|SUPERIORITY_OR_OTHER||Hodges-Lehmann method|-52.1||||0.221|TWO_SIDED|90.0|-89.1|10.8|||Wilcoxon (Mann-Whitney)|||Analysis of Atonic seizure frequency||10.80|-89.10|0.221
71681377|NCT00772005|142881221|SUPERIORITY_OR_OTHER|||||||0.4424||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4424
71906890|NCT01146951|143335757|SUPERIORITY_OR_OTHER|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Analysis of Week 12 of the Treatment Period||||0.041
71906891|NCT01146951|143335757|SUPERIORITY_OR_OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Analysis of final assessment (LOCF)||||0.007
71906892|NCT01299610|143335758|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.38|STANDARD_ERROR_OF_MEAN|0.538||0.48|TWO_SIDED|95.0|-1.46|0.7|||Mixed model for repeated measures|||||0.70|-1.46|0.480
71906893|NCT01299610|143335758|SUPERIORITY_OR_OTHER||mixed model for repeated measures|-0.89|STANDARD_ERROR_OF_MEAN|0.557||0.118|TWO_SIDED|95.0|-2.0|0.23|||Mixed model for repeated measures|||||0.23|-2.00|0.118
71906894|NCT01299610|143335758|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.51|STANDARD_ERROR_OF_MEAN|0.572||0.011|TWO_SIDED|95.0|-2.65|-0.36|||Mixed model for repeated measures|||||-0.36|-2.65|0.011
71906895|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.09|STANDARD_ERROR_OF_MEAN|0.16||0.581|TWO_SIDED|95.0|-0.24|0.42|||Mixed model repeated measures|||GW870086, 0.2% cream Vs Placebo: Day 2||0.42|-0.24|0.581
71860162|NCT02706847|143234897|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.63|||<|0.001|TWO_SIDED|95.0|2.89|6.36||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.36|2.89|<0.001
71860163|NCT02706847|143234898|SUPERIORITY||Response Rate Difference|22.3|||<|0.001|TWO_SIDED|95.0|13.6|31.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||31.1|13.6|<0.001
71860164|NCT02706847|143234898|SUPERIORITY||Response Rate Difference|23.9|||<|0.001|TWO_SIDED|95.0|15.1|32.7||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||32.7|15.1|<0.001
71860165|NCT02706847|143234899|SUPERIORITY||Response Rate Difference|5.1||||0.11|TWO_SIDED|95.0|-1.1|11.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||11.2|-1.1|0.110
71860166|NCT02706847|143234899|SUPERIORITY||Response Rate Difference|16.5|||<|0.001|TWO_SIDED|95.0|9.1|23.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||23.9|9.1|<0.001
71860167|NCT02706847|143234900|SUPERIORITY||Response Rate Difference|16.8|||<|0.001|TWO_SIDED|95.0|8.5|25.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||25.1|8.5|<0.001
71860168|NCT02706847|143234900|SUPERIORITY||Response Rate Difference|14.2|||<|0.001|TWO_SIDED|95.0|6.1|22.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo|||22.3|6.1|<0.001
71860169|NCT05594589|143234918|SUPERIORITY||Least Squares Geometric Mean(LSGM) Ratio|0.377||||0.0133|TWO_SIDED|95.0|0.175|0.81|||ANCOVA|P-value was based on analysis of covariance (ANCOVA) model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 5 mg/Placebo.|||0.810|0.175|0.0133
71681378|NCT00772005|142881222|SUPERIORITY_OR_OTHER|||||||0.4874||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4874
71860170|NCT05594589|143234919|SUPERIORITY||LSGM Ratio|0.48||||0.0619|TWO_SIDED|95.0|0.222|1.038|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSGM ratio was calculated as Lemborexant 10 mg/Placebo.|||1.038|0.222|0.0619
71860171|NCT05594589|143234920|SUPERIORITY||Least Square Mean (LSM) Difference|7.38||||0.0689|TWO_SIDED|95.0|-0.59|15.35|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 5 mg - Placebo.|||15.35|-0.59|0.0689
71860172|NCT05594589|143234921|SUPERIORITY||LSM Difference|8.16||||0.0439|TWO_SIDED|95.0|0.23|16.09|||ANCOVA|P-value was based on ANCOVA model with log transformation of baseline LPS and treatment arms as fixed effects.|LSM difference was calculated as Lemborexant 10 mg - Placebo.|||16.09|0.23|0.0439
71906896|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.08|STANDARD_ERROR_OF_MEAN|0.169||0.655|TWO_SIDED|95.0|-0.42|0.27|||Mixed model repeated measures|||GW870086, 2.0% cream Vs Placebo: Day 2||0.27|-0.42|0.655
71860173|NCT01427738|143234927|SUPERIORITY_OR_OTHER||Difference in proportion with clinical e|0.044|||||TWO_SIDED|95.1|-0.077|0.166||||||Repeated confidence intervals (RCIs) were used to control type I error.A interim analysis was conducted by a 99.7% CI. The final analyses use a 95.1% CI, based on the Lan-DeMets error-spending function corresponding to the O'Brien-Fleming boundary.76% of 100 participant in arm GV had cure or improvement of OC after 14 days of treatment, and 71.6% of 102 in arm nystatin had cure or improvement of OC. Difference in clinical efficacy rates between GV and nystatin 95.1% CI is 0.044 (-0.077, 0.166).||0.166|-0.077|
71860174|NCT01214421|143234939|SUPERIORITY||Ratio of geometric means (final values)|0.99||||0.358|TWO_SIDED|95.0|0.96|1.02|||Mixed Models Analysis||||Derived from the least squares (LS) mean difference between the treatment groups at each visit using MMRM model with factors of treatment, visit, region, baseline, baseline hypertensive status, baseline renal volume status, baseline creatinine clearance status, interaction of treatment and visit, and interaction of baseline and visit.|1.02|0.96|0.358
71860175|NCT01214421|143234940|SUPERIORITY||LS mean difference (final values)|3.15||||0.0003|TWO_SIDED|95.0|1.462|4.836|||Mixed Models Analysis||||Derived from MMRM analysis with fixed factors of treatment, visit, treatment visit interaction, hypertensive status, renal volume status and creatinine clearance status at baseline, region, baseline value, and baseline visit interaction as covariates, and with a heterogeneous toeplitz variance covariance matrix.|4.836|1.462|0.0003
71860176|NCT01214421|143234941|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|1.011||||0.0462|TWO_SIDED|95.0|1.0|1.023|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|1.023|1.000|0.0462
71860177|NCT01214421|143234942|NON_INFERIORITY|The non-inferiority for early-treatment and delayed-treatment groups.|Ratio of geometric means (final values)|-0.113||||0.7259|TWO_SIDED|95.0|-0.746|0.52|||Mixed Models Analysis||||Derived from testing interaction of time and treatment using linear mixed model in which intercept and time are treated as random effects.|0.520|-0.746|0.7259
71906897|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.174||0.336||95.0|-0.52|0.18|||Mixed model repeated measures|||FP, 0.05% cream Vs Placebo: Day 2||0.18|-0.52|0.336
71906898|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.03|STANDARD_ERROR_OF_MEAN|0.302||0.923|TWO_SIDED|95.0|-0.58|0.63|||Mixed model repeated measures|||GW870086 0.2% cream Vs Placebo: Day 3||0.63|-0.58|0.923
71906899|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.14|STANDARD_ERROR_OF_MEAN|0.314||0.657|TWO_SIDED|95.0|-0.49|0.77|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 3||0.77|-0.49|0.657
71906900|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.323||0.386|TWO_SIDED|95.0|-0.93|0.36|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 3||0.36|-0.93|0.386
71906901|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.456||0.601|TWO_SIDED|95.0|-1.15|0.67|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 7||0.67|-1.15|0.601
71906902|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.6|STANDARD_ERROR_OF_MEAN|0.472||0.212|TWO_SIDED|95.0|-1.54|0.35|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 7||0.35|-1.54|0.212
71906903|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.29|STANDARD_ERROR_OF_MEAN|0.485||0.01|TWO_SIDED|95.0|-2.26|-0.32|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 7||-0.32|-2.26|0.010
71906904|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.24|STANDARD_ERROR_OF_MEAN|0.462||0.602|TWO_SIDED|95.0|-1.17|0.68|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 14||0.68|-1.17|0.602
71906905|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.65|STANDARD_ERROR_OF_MEAN|0.479||0.18|TWO_SIDED|95.0|-1.61|0.31|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 14||0.31|-1.61|0.180
71906906|NCT01299610|143335759|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-1.39|STANDARD_ERROR_OF_MEAN|0.492||0.006|TWO_SIDED|95.0|-2.37|-0.4|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 14||-0.40|-2.37|0.006
71906907|NCT00804843|143335769|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.27||||0.811|TWO_SIDED|90.0|-0.24|0.78|||ANOVA|||||0.78|-0.24|0.811
71906908|NCT00804843|143335770|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.64||||0.898|TWO_SIDED|90.0|-1.09|8.36|||ANOVA|||||8.36|-1.09|0.898
71906909|NCT04172701|143335785|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
71906910|NCT04172701|143335786|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
71906911|NCT04172701|143335787|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71906912|NCT04172701|143335788|OTHER||Hazard Ratio (HR)|1.475|||<|0.0001|TWO_SIDED|95.0|1.308|1.663|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model.The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.663|1.308|<0.0001
71906913|NCT04172701|143335789|OTHER|||||||0.0003|||||||Individual log-linked Poisson model|||||||0.0003
71906914|NCT04172701|143335790|OTHER|||||||0.001|||||||Individual t-test or Wilcoxon test|||||||0.001
71906915|NCT04172701|143335791|OTHER||Hazard Ratio (HR)|1.145||||0.0006|TWO_SIDED|95.0|1.059|1.237|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.237|1.059|0.0006
71906916|NCT04172701|143335792|OTHER|||||||0.00074|||||||Log Rank|||||||0.00074
71906917|NCT04172701|143335793|OTHER||||||<|0.0001|||||||Individual log-linked Poisson model|||||||<0.0001
71906918|NCT04172701|143335794|OTHER||Hazard Ratio (HR)|1.601|||<|0.0001|TWO_SIDED|95.0|1.404|1.826|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.826|1.404|<0.0001
71906919|NCT04172701|143335795|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71906920|NCT04172701|143335796|OTHER|||||||0.2875|||||||Wilcoxon (Mann-Whitney)|||||||0.2875
71906921|NCT04172701|143335797|OTHER|||||||0.4602|||||||Individual t-test or Wilcoxon test|||||||0.4602
71906922|NCT04172701|143335798|OTHER|||||||0.0062|||||||Wilcoxon (Mann-Whitney)|||||||0.0062
71906923|NCT04172701|143335799|OTHER|||||||0.0002|||||||Individual t-test or Wilcoxon test|||||||0.0002
71906924|NCT04172701|143335800|OTHER|||||||0.4907|||||||Individual t-test or Wilcoxon test|||||||0.4907
71906925|NCT04172701|143335801|OTHER||||||<|0.001|||||||Individual t-test or Wilcoxon test|||||||<0.001
71906926|NCT04172701|143335802|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71906927|NCT04172701|143335803|OTHER|||||||0.543|||||||Individual t-test or Wilcoxon test|||||||0.543
71906928|NCT04172701|143335804|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.080
71906929|NCT04172701|143335805|OTHER|||||||0.363|||||||Individual t-test or Wilcoxon test|||||||0.363
71906930|NCT04172701|143335806|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
71906931|NCT04172701|143335807|OTHER|||||||0.0494|||||||Individual t-test or Wilcoxon test|||||||0.0494
71906932|NCT04172701|143335808|OTHER|||||||0.0091|||||||Individual t-test or Wilcoxon test|||||||0.0091
71906933|NCT04172701|143335809|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
71906934|NCT04172701|143335810|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
71906935|NCT04172701|143335811|OTHER|||||||0.7298|||||||Individual t-test or Wilcoxon test|||||||0.7298
71906936|NCT04172701|143335812|OTHER|||||||0.0093|||||||Individual t-test or Wilcoxon test|||||||0.0093
71906937|NCT04172701|143335813|OTHER||||||<|0.0001|||||||Individual t-test or Wilcoxon test|||||||<0.0001
71906938|NCT04172701|143335814|OTHER||Cost ratio|1.177|||<|0.0001|TWO_SIDED|95.0|1.104|1.255|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.255|1.104|<0.0001
71860178|NCT01214421|143234943|SUPERIORITY||Ratio of geometric means (final values)|0.992||||0.108|TWO_SIDED|95.0|0.982|1.002|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|1.002|0.982|0.1080
71860179|NCT01214421|143234944|SUPERIORITY||Ratio of geometric means (final values)|0.361||||0.2265|TWO_SIDED|95.0|-0.224|0.946|||Mixed Models Analysis||||Derived from linear mixed model with terms of participant, treatment, time, interaction of treatment and time, interaction of participant and time, and baseline for intra-participant comparison between 251 and 271. Time and intercept are treated as random effects.|0.946|-0.224|0.2265
71860180|NCT04887506|143234998|EQUIVALENCE|If the 90% confidence interval (CI) fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|1.0|||||TWO_SIDED|90.0|||||||The 90% CIs for the geometric mean ratio (GMR) were not evaluable.|Primary analysis of equivalence of TAVT 45 and R AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10).||||
71860181|NCT04887506|143234999|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.975|||||TWO_SIDED|90.0|0.944|1.007||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the CS-ITT population.||1.007|0.944|
71860182|NCT04887506|143235000|EQUIVALENCE|If the 90% CI fell within the recommended 0.800-1.250 limits of equivalence when analyzed on a natural log scale, then treatments were therapeutically equivalent based on rounded-up average Days 9 and 10 testosterone levels.|Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.978|1.002||||||Supplementary analysis of equivalence of TAVT-45 and R-AA based on average serum testosterone (ng/dL) (rounded up values of Days 9 and 10) in the mITT population.||1.002|0.978|
71860183|NCT04887506|143235001|EQUIVALENCE|Odds ratio generated using the Wald method.|Odds Ratio (OR)|1.69||||0.3408|TWO_SIDED|95.0|0.574|4.979|||Regression, Logistic|||||4.979|0.574|0.3408
71860184|NCT01999777|143235002|SUPERIORITY|||||||0.1972|||||||Wald asymptotic|P-value based on a standard Wald asymptotic test for equality without a continuity correction.||Assumptions included that the proportion of seizures occurring within 6 hours after placebo administration was \~65% and a relative reduction of 50% would result in a reduction of ≥ 32.5 percentage points. Based on a 2-sided 95% confidence interval (CI) for the differences in proportions, a sample size of 62 analyzable subjects was chosen to detect a 0.35 difference between group. Sample size estimations were based on nQuery Version 7.0 using the table for CIs for differences in 2 proportions.||||0.1972
71906939|NCT04172701|143335815|OTHER||Cost ratio|1.194||||0.0103|TWO_SIDED|95.0|1.043|1.367|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.367|1.043|0.0103
71906940|NCT04172701|143335816|OTHER||Cost ratio|1.104||||0.003|TWO_SIDED|95.0|1.034|1.178|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.178|1.034|0.0030
71906941|NCT04172701|143335817|OTHER||Cost ratio|1.175|||<|0.0001|TWO_SIDED|95.0|1.13|1.221|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.221|1.130|<0.0001
71906942|NCT04172701|143335818|OTHER||Cost ratio|1.236|||<|0.0001|TWO_SIDED|95.0|1.134|1.346|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.346|1.134|<0.0001
71906943|NCT04172701|143335819|OTHER||Cost ratio|1.214||||0.0212|TWO_SIDED|95.0|1.029|1.431|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.431|1.029|0.0212
71906944|NCT04172701|143335820|OTHER||Cost ratio|1.026||||0.5024|TWO_SIDED|95.0|0.952|1.105|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.105|0.952|0.5024
71860185|NCT01999777|143235003|SUPERIORITY|||||||0.1388|||||||Log Rank|||||||0.1388
71882342|NCT00563186|143283612|SUPERIORITY_OR_OTHER|This statistical analysis applies to the overall VRE, CDI and MRSA infection and colonization events expressed as incidence density (per 1000 patient-days at risk).|Incidence Rate ratio|1.6|STANDARD_ERROR_OF_MEAN|0.57||0.18|TWO_SIDED|95.0|0.8|3.22|||Poisson||Numerator is novel ward and denominator is traditional ward.|"It was calculated that this study will require 9750 patient days of observation in the traditional design wards and 19,500 patient days of observation in the novel design ward to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units"||3.22|0.80|0.18
71906945|NCT04172701|143335821|OTHER||Cost ratio|1.304|||<|0.0001|TWO_SIDED|95.0|1.243|1.369|||Individual t-test or Wilcoxon test||cost ratio = cost of ICS/LABA divided by cost of LAMA|||1.369|1.243|<0.0001
71906946|NCT04172701|143335822|OTHER|||||||0.7198|||||||Individual log-linked Poisson model|||||||0.7198
71906947|NCT04172701|143335823|OTHER||Hazard Ratio (HR)|1.072||||0.7341|TWO_SIDED|95.0|0.719|1.598|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.598|0.719|0.7341
71906948|NCT04172701|143335824|OTHER|||||||0.74|||||||Log Rank|||||||0.74
71906949|NCT04172701|143335825|OTHER|||||||0.9985|||||||Individual log-linked Poisson model|||||||0.9985
71922020|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-5.1|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||7.4|-5.1|
71922021|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-3.4|9.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 2, post-dose PM 4 hour||9.2|-3.4|
71922022|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.5|4.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||4.8|-7.5|
71860186|NCT01255761|143235030|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.|Difference in proportion|-0.119|||||TWO_SIDED|95.0|-0.184|-0.053||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||-0.053|-0.184|
71882343|NCT00563186|143283614|SUPERIORITY_OR_OTHER||Rate Ratio|1.929|STANDARD_ERROR_OF_MEAN|0.493||0.175|TWO_SIDED|95.0|0.76|4.9|||Large test for person-time analysis|||||4.9|0.76|0.175
71882344|NCT00135668|143283674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.2|STANDARD_DEVIATION|16.16|<|0.001|TWO_SIDED|95.0|-18.44|-13.97|||t-test, 2 sided|Paired t-test used.||Paired t-test used to test the null hypothesis of no change in MAP from baseline.||-13.97|-18.44|<0.001
71882345|NCT00135668|143283674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_DEVIATION|15.68|<|0.001|TWO_SIDED|95.0|-15.45|-6.55|||t-test, 2 sided|Paired t-test.||||-6.55|-15.45|<0.001
71681379|NCT00772005|142881222|SUPERIORITY_OR_OTHER|||||||0.8243||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8243
71860187|NCT01255761|143235031|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.|Difference in proportion|-0.013|||||TWO_SIDED|95.0|-0.093|0.066||Study was intended to show the comparability of RAPID3 with CDAI. Assessment of whether the study objective was met was based on CIs rather than p-values. Both variables need to be significant to claim comparability between the two assessment tools.|ANCOVA|Difference in proportions from ANCOVA with tool as factor \& Baseline DAS28(ESR), gender, age, prior anti-TNF use \& disease duration as covariates.||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."||0.066|-0.093|
71860188|NCT03506347|143235069|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
71860189|NCT03506347|143235070|SUPERIORITY|||||||0.009|||||||ANOVA|||||||0.009
71860190|NCT05613088|143235083|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.4063|TWO_SIDED|95.0|0.76|2.0|||Log Rank|||||2.00|0.76|0.4063
71860191|NCT03912532|143235084|OTHER|The Multiple Comparison Procedure-Modelling (MCP-Mod) is a 2-stage procedure in which dose-response models are selected at the design stage. These candidate models are used for both dose-response testing (MCP step) and estimation (Mod step). The dose-response testing is performed using a multiple comparison method to account for the multiplicity issue associated with the multiple candidate models. Missing responses were imputed using multiple imputation under the assumption of missing at random.||||||0.5534|||||||Multiple comparison procedure step|||||||0.5534
71860192|NCT02825251|143235136|NON_INFERIORITY|Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.|Treatment difference|0.09|||||TWO_SIDED|95.0|0.01|0.17|||ANOVA|||Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.||0.17|0.01|
71860193|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.098|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS X axis||||0.098
71860194|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Y axis||||0.389
71860195|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||ANS Z axis||||0.780
71860196|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.054|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.054
71860197|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.323|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point Y axis||||0.323
71860198|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.371|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||A point X axis||||0.371
71860199|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level X axis||||0.011
71860200|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.426|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Y axis||||0.426
71860201|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.621|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||UI level Z axis||||0.621
71860202|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.275|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale X axis||||0.275
71860203|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Y axis||||0.361
71860204|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||pronasale Z axis||||0.284
71860205|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.119|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale X axis||||0.119
71860206|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Y axis||||0.019
71860207|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||subnasale Z axis||||0.034
71860208|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious X axis||||0.422
71860209|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.177|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Y axis||||0.177
71860210|NCT01473745|143235231|SUPERIORITY_OR_OTHER|||||||0.133|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||labiale superious Z axis||||0.133
71860211|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Intercanthal distance||||0.218
71860212|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance.||nasal height||||0.336
71860213|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|P- value \< 0.05 was set as statistical significance||||||0.192
71860214|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.135|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal tip protrusion||||0.135
71860215|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.277|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||nasal width||||0.277
71860216|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.505|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.505
71860217|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.299
71860218|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.738|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.738
71860219|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.008
71860220|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.116|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneious height of upper lip||||0.116
71860221|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.528|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.528
71860222|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.123
71906950|NCT04172701|143335826|OTHER||Hazard Ratio (HR)|0.879||||0.5097|TWO_SIDED|95.0|0.6|1.289|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.289|0.600|0.5097
71906951|NCT04172701|143335827|OTHER|||||||0.51|||||||Log Rank|||||||0.51
71906952|NCT04172701|143335828|OTHER|||||||0.6069|||||||Individual log-linked Poisson model|||||||0.6069
71906953|NCT04172701|143335829|OTHER||Hazard Ratio (HR)|1.025||||0.896|TWO_SIDED|95.0|0.705|1.49|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.490|0.705|0.8960
71860223|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.250
71906954|NCT04172701|143335830|OTHER|||||||0.9|||||||Log Rank|||||||0.9
71906955|NCT04172701|143335831|OTHER|||||||0.1354|||||||Individual log-linked Poisson model|||||||0.1354
71906956|NCT04172701|143335832|OTHER||Hazard Ratio (HR)|0.59||||0.1158|TWO_SIDED|95.0|0.305|1.139|||Regression, Cox|||The Cox proportional hazards regression took into account the fact that individual matching (1:1) was performed by considering the exposed patient and his/her matched control as one stratum and including this as a stratum in the Cox proportional hazards model. The presented Hazard Ratio (HR) was estimated using the LAMA as a reference group.||1.139|0.305|0.1158
71906957|NCT04172701|143335833|OTHER|||||||0.11|||||||Log Rank|||||||0.11
71860224|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.706|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.706
71906958|NCT02126670|143335834|SUPERIORITY_OR_OTHER|||||||0.799|TWO_SIDED||||||Chi-squared|||||||0.799
71906959|NCT01975246|143335836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-5.3|-2.4|||ANCOVA|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-2.4|-5.3|<0.0001
71906960|NCT01975246|143335837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-7.6|-3.1|||ANCOVA|Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.||-3.1|-7.6|<0.0001
71860225|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.804|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.804
71860226|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.114|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.114
71860227|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal length||||0.457
71860228|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.565|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||Nasal tip protrusion||||0.565
71860229|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.781|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.781
71860230|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.164|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.164
71860231|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.554
71860232|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.508|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.508
71860233|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.358
71860234|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.049
71860235|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
71860236|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.062
71860237|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.029
71860238|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.011
71860239|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.211|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||intercanthal distance||||0.211
71681380|NCT00772005|142881222|SUPERIORITY_OR_OTHER|||||||0.9562||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9562
71681381|NCT00772005|142881223|SUPERIORITY_OR_OTHER|||||||0.3686||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3686
71681382|NCT00772005|142881223|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0270
71860240|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal height||||0.102
71860241|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.136|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal length||||0.136
71860242|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal tip protrusion||||0.113
71860243|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||nasal width||||0.115
71860244|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.535|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||alar base width||||0.535
71860245|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||R nostril show vertical dimension||||0.850
71860246|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.891|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||L nostril show vertical dimension||||0.891
71860247|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.262|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||columellar length||||0.262
71860248|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.344|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||cutaneous height of upper lip||||0.344
71906961|NCT01975246|143335838|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1|||<|0.0051|TWO_SIDED|95.0|1.2|3.4|||Regression, Logistic|Logistic regression model includes treatment and center as fixed effects.||"The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as failure up to the planned final visit to be reached by all patients."||3.4|1.2|<0.0051
71860249|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.057|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||overall upper lip height||||0.057
71860250|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.995|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||vermillion height of upper lip||||0.995
71860251|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||lower prolabial width||||0.440
71860252|NCT01473745|143235232|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||t-test, 2 sided|P-value \< 0.05 was set as statistical significance(\*).||upper lip protrusion||||0.078
71906962|NCT01263093|143335840|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.77|||||TWO_SIDED|90.0|0.72|0.83|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.83|0.72|
71906963|NCT01263093|143335841|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.59|||||TWO_SIDED|90.0|0.53|0.67|||Mixed Models Analysis||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.|||0.67|0.53|
71906964|NCT01263093|143335843|SUPERIORITY_OR_OTHER||Median of Paired Differences|0.0||||0.3303|TWO_SIDED|90.0|0.0|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|0.00|0.3303
71906965|NCT05263921|143335900|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|107.35|||||TWO_SIDED|90.0|99.66|115.64||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||115.64|99.66|
71860253|NCT01473745|143235233|SUPERIORITY_OR_OTHER|||||||0.104|TWO_SIDED|||||intergroup difference of conventional group|t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.104
71860254|NCT01473745|143235233|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||Intergroup difference of modified group|t-test, 2 sided|P value \<0.05 was set as statistical significance.||||||0.043
71860255|NCT01473745|143235233|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||t-test, 2 sided|P value \< 0.05 was set as statistical significance.||||||0.888
71860256|NCT02366143|143235248|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.74|||Log Rank|||ITT-WT population||0.74|0.52|<0.0001
71860257|NCT02366143|143235248|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.68|||Log Rank|||Teff-high WT Population||0.68|0.38|<0.0001
71860258|NCT02366143|143235249|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.78||||0.0164|TWO_SIDED|95.0|0.64|0.96|||Log Rank|||||0.96|0.64|0.0164
71860259|NCT02366143|143235250|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.842||||0.0528|TWO_SIDED|95.0|0.707|1.002|||Log Rank|||||1.002|0.707|0.0528
71860260|NCT02366143|143235251|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||ITT-WT population||0.85|0.59|0.0002
71860261|NCT02366143|143235251|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.564||||0.0001|TWO_SIDED|95.0|0.418|0.76|||Log Rank|||Teff-high WT Population||0.760|0.418|0.0001
71860262|NCT02366143|143235252|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.492|||<|0.0001|TWO_SIDED|95.0|0.374|0.649|||Log Rank|||Teff-high Population||0.649|0.374|<.0001
71860263|NCT02366143|143235252|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.517|0.72|||Log Rank|||ITT Population||0.720|0.517|<.0001
71860264|NCT02366143|143235254|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.471|||<|0.0001|TWO_SIDED|95.0|0.352|0.647|||Log Rank|||TC2/3 or IC2/3 Subgroup||0.647|0.352|<.0001
71860265|NCT02366143|143235254|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.486|||<|0.0001|TWO_SIDED|95.0|0.386|0.639|||Log Rank|||TC1/2/3 or IC1/2/3 Subgroup||0.639|0.386|<.0001
71906966|NCT05263921|143335900|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.73|||||TWO_SIDED|90.0|112.09|130.03||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.03|112.09|
71906967|NCT05263921|143335900|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|125.04|||||TWO_SIDED|90.0|116.08|134.69||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||134.69|116.08|
71906968|NCT05263921|143335901|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.8|||||TWO_SIDED|90.0|101.06|117.14||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||117.14|101.06|
71906969|NCT05263921|143335901|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|120.95|||||TWO_SIDED|90.0|112.36|130.2||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||130.20|112.36|
71906970|NCT05263921|143335901|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|127.39|||||TWO_SIDED|90.0|118.32|137.15||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||137.15|118.32|
71906971|NCT05263921|143335902|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|115.1|||||TWO_SIDED|90.0|104.03|127.34||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||127.34|104.03|
71906972|NCT05263921|143335902|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|145.6|||||TWO_SIDED|90.0|131.68|160.99||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||160.99|131.68|
71906973|NCT05263921|143335902|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|161.48|||||TWO_SIDED|90.0|145.95|178.66||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||178.66|145.95|
71906974|NCT05263921|143335903|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.85|||||TWO_SIDED|90.0|95.38|128.82||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.82|95.38|
71906975|NCT05263921|143335903|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|106.55|||||TWO_SIDED|90.0|91.76|123.73||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||123.73|91.76|
71906976|NCT05263921|143335903|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.74|||||TWO_SIDED|90.0|92.7|125.21||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.21|92.70|
71906977|NCT05263921|143335904|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|110.19|||||TWO_SIDED|90.0|94.51|128.47||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||128.47|94.51|
71906978|NCT05263921|143335904|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.17|||||TWO_SIDED|90.0|92.0|124.86||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||124.86|92.00|
71906979|NCT05263921|143335904|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|107.83|||||TWO_SIDED|90.0|92.48|125.72||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||125.72|92.48|
71906980|NCT05263921|143335905|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric means|108.72|||||TWO_SIDED|90.0|89.32|132.32||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets; Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with water||132.32|89.32|
71906981|NCT05263921|143335905|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|109.44|||||TWO_SIDED|90.0|90.05|133.0||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with applesauce||133.00|90.05|
71906982|NCT05263921|143335905|OTHER|The ratio and 90% CI were expressed as percentages.|Ratio (%) of Adjusted Geometric Means|117.3|||||TWO_SIDED|90.0|96.37|142.77||||||Reference: Nirmatrelvir/ritonavir 300/100 mg commercial tablets Test: Nirmatrelvir/ritonavir 300/100 mg oral powder mixed with vanilla pudding||142.77|96.37|
71906983|NCT03292952|143335927|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71906984|NCT02667457|143335967|OTHER|||||||0.0095||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0095
71906985|NCT02667457|143335967|OTHER|||||||0.0029||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0029
71906986|NCT02667457|143335968|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
71906987|NCT02667457|143335968|OTHER|||||||0.0334||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0334
71906988|NCT02667457|143335969|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
71906989|NCT02667457|143335969|OTHER|||||||0.0301||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0301
71681383|NCT00772005|142881223|SUPERIORITY_OR_OTHER|||||||0.7322||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7322
71681384|NCT00772005|142881224|SUPERIORITY_OR_OTHER|||||||0.4646||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4646
71681385|NCT00772005|142881224|SUPERIORITY_OR_OTHER|||||||0.8783||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8783
71860266|NCT02366143|143235255|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.824||||0.2765|TWO_SIDED|95.0|0.58|1.169|||Log Rank|||TC2/3 or IC2/3, WT ITT||1.169|0.580|0.2765
71681386|NCT00772005|142881224|SUPERIORITY_OR_OTHER|||||||0.4213||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4213
71681387|NCT00772005|142881225|SUPERIORITY_OR_OTHER|||||||0.6597||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6597
71681388|NCT00772005|142881225|SUPERIORITY_OR_OTHER|||||||0.0262||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0262
71681389|NCT00772005|142881225|SUPERIORITY_OR_OTHER|||||||0.6652||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6652
71860267|NCT02366143|143235255|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.771||||0.0829|TWO_SIDED|95.0|0.575|1.035|||Log Rank|||TC1/2/3 or IC1/2/3, WT ITT||1.035|0.575|0.0829
71860268|NCT02366143|143235256|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.709||||0.0073|TWO_SIDED|95.0|0.551|0.913|||Log Rank|||TC1/2/3 or IC1/2/3 ITT-WT||0.913|0.551|0.0073
71860269|NCT02366143|143235256|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.662||||0.0097|TWO_SIDED|95.0|0.484|0.907|||Log Rank|||TC2/3 or IC2/3 Population||0.907|0.484|0.0097
71860270|NCT02366143|143235257|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.831||||0.2843|TWO_SIDED|95.0|0.592|1.167|||Log Rank|||Teff high-WT||1.167|0.592|0.2843
71860271|NCT02366143|143235257|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.802||||0.1861|TWO_SIDED|95.0|0.579|1.113|||Log Rank|||Teff high||1.113|0.579|0.1861
71860272|NCT02366143|143235257|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.764||||0.006|TWO_SIDED|95.0|0.63|0.926|||Log Rank|||ITT||0.926|0.630|0.0060
71860273|NCT02366143|143235258|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.786||||0.0894|TWO_SIDED|95.0|0.595|1.038|||Log Rank|||Teff high-WT||1.038|0.595|0.0894
71860274|NCT02366143|143235258|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.815||||0.1276|TWO_SIDED|95.0|0.626|1.061|||Log Rank|||Teff high||1.061|0.626|0.1276
71860275|NCT02366143|143235258|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.861||||0.0681|TWO_SIDED|95.0|0.733|1.011|||Log Rank|||ITT||1.011|0.733|0.0681
71860276|NCT02366143|143235259|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.901||||0.4599|TWO_SIDED|95.0|0.683|1.188|||Log Rank|||Teff high-WT ITT||1.188|0.683|0.4599
71860277|NCT02366143|143235260|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.523|||<|0.0001|TWO_SIDED|95.0|0.406|0.675|||Log Rank|||ITT-WT||0.675|0.406|<.0001
71860278|NCT02366143|143235260|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.283|0.624|||Log Rank|||Teff-high WT||0.624|0.283|<.0001
71860279|NCT02366143|143235262|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|6.68||||0.0697|TWO_SIDED|95.0|-0.54|13.9|||Z-test|||1-Year ITT-WT Population||13.90|-0.54|0.0697
71860280|NCT02366143|143235262|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.71||||0.0347|TWO_SIDED|95.0|0.7|18.73|||Z-test|||2-Year ITT-WT Population||18.73|0.70|0.0347
71860281|NCT02366143|143235262|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.89||||0.089|TWO_SIDED|95.0|-1.51|21.29|||Z-test|||1-Year Teff-high WT Population||21.29|-1.51|0.0890
71860282|NCT02366143|143235262|OTHER|Stratified Analysis|Difference in Event Free Rate|10.34||||0.1336|TWO_SIDED|95.0|-3.17|23.84|||Z-test|||2-Year Teff-high WT Population||23.84|-3.17|0.1336
71860283|NCT02366143|143235263|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|4.18||||0.2624|TWO_SIDED|95.0|-3.13|11.48|||Z-test|||1-Year ITT-WT Population||11.48|-3.13|0.2624
71860284|NCT02366143|143235263|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|9.67||||0.0088|TWO_SIDED|95.0|2.43|16.9|||Z-test|||2-Year ITT-WT Population||16.90|2.43|0.0088
71860285|NCT02366143|143235263|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|10.56||||0.0649|TWO_SIDED|95.0|-0.65|21.77|||Z-test|||1-Year Teff-high WT Population||21.77|-0.65|0.0649
71860286|NCT02366143|143235263|SUPERIORITY|Stratified Analysis|Difference in Event Free Rate|7.27||||0.212|TWO_SIDED|95.0|-4.15|18.69|||Z-test|||2-Year Teff-high WT Population||18.69|-4.15|0.2120
71860287|NCT02366143|143235264|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.909||||0.6899|TWO_SIDED|95.0|0.571|1.45|||Log Rank|||Teff-high WT Population||1.450|0.571|0.6899
71860288|NCT02366143|143235264|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.671||||0.1043|TWO_SIDED|95.0|0.413|1.089|||Log Rank|||Teff-high WT Population||1.089|0.413|0.1043
71860289|NCT02366143|143235264|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.232||||0.173||95.0|0.912|1.665|||Log Rank|||ITT WT||1.665|0.912|0.1730
71860290|NCT02366143|143235264|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.084||||0.6145|TWO_SIDED|95.0|0.792|1.483|||Log Rank|||ITT WT||1.483|0.792|0.6145
71860291|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.8816|TWO_SIDED|95.0|0.614|1.763|||Log Rank|||Cough for Teff-high WT ITT population||1.763|0.614|0.8816
71860292|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.741||||0.2995|TWO_SIDED|95.0|0.419|1.309|||Log Rank|||Cough for Teff-high WT ITT Population||1.309|0.419|0.2995
71860293|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.936||||0.7578|TWO_SIDED|95.0|0.616|1.422|||Log Rank|||Dyspnea in Teff-high WT Population||1.422|0.616|0.7578
71860294|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.041||||0.847|TWO_SIDED|95.0|0.694|1.56|||Log Rank|||Dyspnea in Teff-high WT Population||1.560|0.694|0.8470
71860295|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.659||||0.1289|TWO_SIDED|95.0|0.383|1.133|||Log Rank|||Pain in Chest in Teff-high WT Population||1.133|0.383|0.1289
71906990|NCT02667457|143335970|OTHER|||||||0.0066||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0066
71906991|NCT02667457|143335970|OTHER|||||||0.0387||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0387
71906992|NCT02667457|143335971|OTHER|||||||0.0359||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 60 minutes||||0.0359
71906993|NCT02667457|143335971|OTHER|||||||0.0022||||||p-value is based on t-test with unequal variances (Satterthwaite) if p-value of F-test for Equality of variances is significant (p\<0.05) otherwise p-value is based on t-test with equal variances.|t-test, 1 sided|||Timepoint = 120 minutes||||0.0022
71906994|NCT02475850|143335976|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.245|TWO_SIDED|95.0|0.8|1.06||p\<0.05 threshold (primary outcome)|Regression, Cox|multistate model accounting for death as a semi-competing risk||||1.06|0.80|0.245
71906995|NCT02475850|143335977|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.004|TWO_SIDED|99.0|0.83|0.99||p\< 0.01 threshold (secondary outcome)|Regression, Cox|||||0.99|0.83|0.004
71906996|NCT02475850|143335979|SUPERIORITY||Difference in least-squared means across|0.72|STANDARD_ERROR_OF_MEAN|0.71||0.309|TWO_SIDED|99.0|-1.1|2.54||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||2.54|-1.10|0.309
71906997|NCT02475850|143335980|SUPERIORITY||Least squares means|0.59||||0.528|TWO_SIDED|99.0|-1.8|0.93||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||0.93|-1.80|0.528
71906998|NCT02475850|143335981|SUPERIORITY||Least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.43||0.037|TWO_SIDED|99.0|-2.0|0.2||p \< 0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months/24 months)|||0.20|-2.00|0.037
71906999|NCT02475850|143335982|SUPERIORITY||Least squares means|-1.19|STANDARD_ERROR_OF_MEAN|0.45||0.009|TWO_SIDED|99.0|-2.36|-0.02||p\<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness||||-0.02|-2.36|0.009
71907000|NCT02475850|143335983|SUPERIORITY||Least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.51||0.897|TWO_SIDED|99.0|-1.38|1.25||p \<0.01 threshold (secondary outcome)|Mixed Models Analysis|random: patients nested within practices; fixed: baseline score, randomization constraint vars, predictors of missingness|Difference in least-squared means across all follow-up (repeated measures: 12 months, 24 months)|||1.25|-1.38|0.897
71907001|NCT01746940|143335984|SUPERIORITY_OR_OTHER|||||||0.1088||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.1088
71907002|NCT01746940|143335984|SUPERIORITY_OR_OTHER|||||||0.0005||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.||||0.0005
71907003|NCT02700919|143336002|SUPERIORITY|||||||0.012|||||||Log Rank|||Change from Baseline on Day 7||||0.012
71907004|NCT02700919|143336002|SUPERIORITY||||||<|0.001|||||||Log Rank|||Change from Baseline on Day 7||||<0.001
71907005|NCT02700919|143336002|SUPERIORITY|||||||0.102|||||||Log Rank|||Change from Baseline on Day 7||||0.102
71907006|NCT02700919|143336002|SUPERIORITY||Mean Difference (Final Values)|0.027||||0.507|TWO_SIDED|95.0|-0.053|0.107|||Mixed Models Analysis|||Day 7||0.107|-0.053|0.507
71907007|NCT02700919|143336002|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.148|TWO_SIDED|95.0|-0.021|0.136|||Mixed Models Analysis|||Day 7||0.136|-0.021|0.148
71907008|NCT02700919|143336002|SUPERIORITY||Mean Difference (Final Values)|-0.031||||0.443|TWO_SIDED|95.0|-0.109|0.048|||Mixed Models Analysis|||Day 7||0.048|-0.109|0.443
71907009|NCT02700919|143336006|SUPERIORITY|||||||0.399|||||||Log Rank|||||||0.399
71907010|NCT02700919|143336006|SUPERIORITY|||||||0.091|||||||Log Rank|||||||0.091
71907011|NCT02700919|143336006|SUPERIORITY|||||||0.437|||||||Log Rank|||||||0.437
71860296|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.729||||0.2381|TWO_SIDED|95.0|0.43|1.235|||Log Rank|||Pain in Chest in Teff-high WT Population||1.235|0.430|0.2381
71860297|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.09||||0.7163|TWO_SIDED|95.0|0.685|1.732|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.732|0.685|0.7163
71860298|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.693||||0.1502|TWO_SIDED|95.0|0.42|1.145|||Log Rank|||Arm and/or Shoulder Pain in Teff-high WT||1.145|0.420|0.1502
71860299|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.01||||0.9568|TWO_SIDED|95.0|0.713|1.43|||Log Rank|||Cough in ITT-WT Population||1.430|0.713|0.9568
71860300|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.891||||0.5377|TWO_SIDED|95.0|0.619|1.284|||Log Rank|||Cough in ITT-WT Population||1.284|0.619|0.5377
71860301|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.4012|TWO_SIDED|95.0|0.685|1.163|||Log Rank|||Dyspnea in ITT-WT Population||1.163|0.685|0.4012
71907012|NCT02700919|143336010|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.720
71907013|NCT02700919|143336010|SUPERIORITY|||||||0.298|||||||Log Rank|||||||0.298
71907014|NCT02700919|143336010|SUPERIORITY|||||||0.47|||||||Log Rank|||||||0.470
71860302|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.05||||0.7149|TWO_SIDED|95.0|0.809|1.363|||Log Rank|||Dyspnea in ITT-WT Population||1.363|0.809|0.7149
71907015|NCT01253187|143336030|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.03||||||90.0|98.86|113.72||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.72|98.86|
71907016|NCT01253187|143336031|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|103.47||||||90.0|99.16|107.98||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.98|99.16|
71860303|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|1.057||||0.7126|TWO_SIDED|95.0|0.786|1.422|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.422|0.786|0.7126
71860304|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.921||||0.6053|TWO_SIDED|95.0|0.675|1.258|||Log Rank|||Arm and/or Shoulder Pain in ITT-WT||1.258|0.675|0.6053
71860305|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.829||||0.3134|TWO_SIDED|95.0|0.576|1.194|||Log Rank|||Pain in Chest in ITT-WT Population||1.194|0.576|0.3134
71860306|NCT02366143|143235265|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.91||||0.6115|TWO_SIDED|95.0|0.633|1.309|||Log Rank|||Pain in Chest in ITT-WT Population||1.309|0.633|0.6115
71860307|NCT02820597|143235279|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.||Null hypothesis is that the within-participant change from baseline in rTNSS is 0.||||<0.001
71860308|NCT02820597|143235280|SUPERIORITY||||||<|0.001||||||Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.|t-test, 2 sided|||Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.||||<0.001
71860309|NCT00575042|143235283|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||Sample size calculation estimated that with 20 patients, and assuming a 10% drop-out rate, the study would have 80% power to detect a response rate in 35% or more of the study patients. A two-sided p value\<0.05 was considered statistically significant.||||<0.0001
71860310|NCT03898700|143235289|OTHER||Median Difference (Final Values)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
71922023|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.4|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.5|5.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, pre-dose AM||5.8|-6.5|
71922024|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-9.9|5.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||5.3|-9.9|
71922025|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.2|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|9.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 3, post-dose PM 4 hour||9.8|-5.4|
71860311|NCT03898700|143235289|OTHER||Median Difference (Net)|2.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.||||<0.001
71860312|NCT00158197|143235292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98|||<|0.01|TWO_SIDED||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
71860313|NCT00158197|143235292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
71860314|NCT00158197|143235292|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.|||||<0.01
71860315|NCT00158197|143235293|SUPERIORITY_OR_OTHER|||||||0.02||||||Yes, the a priori plan to handle post hoc multiple comparisons was to use the method of Bonferroni adjustment. Thus, the new alpha level for these comparisons was \<0.0125.|ANOVA|||||||0.02
71860316|NCT00158197|143235293|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71860317|NCT00158197|143235293|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71860318|NCT00158197|143235293|SUPERIORITY_OR_OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
71860319|NCT00158197|143235294|SUPERIORITY_OR_OTHER|||||||0.78|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.78
71860320|NCT00158197|143235294|SUPERIORITY_OR_OTHER|||||||0.68|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.68
71907017|NCT01253187|143336032|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|105.24||||||90.0|97.3|113.83||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.83|97.30|
71907018|NCT01253187|143336033|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.48||||||90.0|97.28|103.79||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.79|97.28|
71907019|NCT01253187|143336034|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|91.24|109.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||109.34|91.24|
71907020|NCT01253187|143336035|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.16||||||90.0|93.95|102.57||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.57|93.95|
71907021|NCT01253187|143336036|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.28||||||90.0|93.15|107.95||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||107.95|93.15|
71907022|NCT01253187|143336037|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|95.38|104.58||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.58|95.38|
71907023|NCT01253187|143336039|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.3||||||90.0|97.65|103.02||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE20/DRSP/L-5-MTHF Ca) / YAZ\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|32 volunteers qualified for statistical analysis of BE whereas all 34 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.02|97.65|
71860321|NCT00158197|143235294|SUPERIORITY_OR_OTHER|||||||0.2|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.||||0.20
71681390|NCT00772005|142881226|SUPERIORITY_OR_OTHER|||||||0.3355||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3355
71860322|NCT03616964|143235298|SUPERIORITY||Odds Ratio (OR)|1.07||||0.711|TWO_SIDED|95.0|0.75|1.53|||Regression, Logistic|||||1.53|0.75|0.711
71860323|NCT03616964|143235299|SUPERIORITY||Odds Ratio (OR)|1.05||||0.789|TWO_SIDED|95.0|0.73|1.5|||Regression, Logistic|||||1.50|0.73|0.789
71860324|NCT03616964|143235300|SUPERIORITY||Odds Ratio (OR)|1.1||||0.673|TWO_SIDED|95.0|0.72|1.68|||Regression, Logistic|||||1.68|0.72|0.673
71860325|NCT03616964|143235300|SUPERIORITY||Odds Ratio (OR)|1.15||||0.528|TWO_SIDED|95.0|0.75|1.75|||Regression, Logistic|||||1.75|0.75|0.528
71860326|NCT03616964|143235302|SUPERIORITY||Odds Ratio (OR)|0.91||||0.761|TWO_SIDED|95.0|0.51|1.64|||Regression, Logistic|||||1.64|0.51|0.761
71860327|NCT03616964|143235302|SUPERIORITY||Odds Ratio (OR)|1.17||||0.611|TWO_SIDED|95.0|0.65|2.1|||Regression, Logistic|||||2.10|0.65|0.611
71860328|NCT03616964|143235303|SUPERIORITY||LS Mean difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.2||0.698|TWO_SIDED|95.0|-0.47|0.32|||Mixed Models Analysis|||||0.32|-0.47|0.698
71860329|NCT03616964|143235303|SUPERIORITY||LS Mean difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.2||0.744|TWO_SIDED|95.0|-0.46|0.33|||Mixed Models Analysis|||||0.33|-0.46|0.744
71681391|NCT00772005|142881226|SUPERIORITY_OR_OTHER|||||||0.0953||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0953
71681392|NCT00772005|142881226|SUPERIORITY_OR_OTHER|||||||0.9235||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9235
71681393|NCT00772005|142881227|SUPERIORITY_OR_OTHER|||||||0.4164||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4164
71681394|NCT00772005|142881227|SUPERIORITY_OR_OTHER|||||||0.3003||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3003
71860330|NCT03616964|143235304|SUPERIORITY||LS Mean difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.84||0.665|TWO_SIDED|95.0|-2.0|1.28|||Mixed Models Analysis|||||1.28|-2.00|0.665
71860331|NCT03616964|143235304|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.84||0.723|TWO_SIDED|95.0|-1.95|1.35|||Mixed Models Analysis|||||1.35|-1.95|0.723
71860332|NCT03616964|143235305|SUPERIORITY||Odds Ratio (OR)|0.69||||0.372|TWO_SIDED|95.0|0.31|1.55|||Regression, Logistic|||||1.55|0.31|0.372
71860333|NCT03616964|143235305|SUPERIORITY||Odds Ratio (OR)|0.78||||0.555|TWO_SIDED|95.0|0.34|1.78|||Regression, Logistic|||||1.78|0.34|0.555
71860334|NCT03616964|143235306|SUPERIORITY||LS Mean difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.422||0.251|TWO_SIDED|95.0|-1.31|0.34|||Mixed Models Analysis|||||0.34|-1.31|0.251
71860335|NCT03616964|143235306|SUPERIORITY||LS Mean difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.425||0.333|TWO_SIDED|95.0|-1.74|-0.07|||Mixed Models Analysis|||||-0.07|-1.74|0.333
71860336|NCT03616964|143235307|SUPERIORITY||LS Mean difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.282||0.284|TWO_SIDED|95.0|-0.86|0.25|||Mixed Models Analysis|||||0.25|-0.86|0.284
71860337|NCT03616964|143235307|SUPERIORITY||LS Mean difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.284||0.069|TWO_SIDED|95.0|-1.08|0.04|||Mixed Models Analysis|||||0.04|-1.08|0.069
71860338|NCT00656201|143235310|NON_INFERIORITY_OR_EQUIVALENCE|This was an equivalence comparison. The study was designed to detect a 14% pregnancy difference between the arms with 80% power and one interim analysis using O'Brien-Fleming parameters and an experiment-wise alpha level of 5%.|Odds Ratio (OR)|1.2|||<|0.05|TWO_SIDED|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)||Crinone is the numerator and IM Progesterone is the denominator.|||1.8|0.8|<0.05
71860339|NCT04367480|143235344|SUPERIORITY||Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.81||0.199|TWO_SIDED|95.0|-0.56|2.67|||ANCOVA|||"Missing data were accounted for using multiple imputation (MI) with the fully conditional specification (FCS) method. 100 replicates were imputed.~ANCOVA analysis was applied within each replicate. SAS PROC MI and MIANALYZE were used to calculate the reported estimates. (N: Active TENS=71, Placebo TENS=70)"||2.67|-0.56|0.199
71860340|NCT04367480|143235345|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.36||0.302|TWO_SIDED|95.0|-0.34|1.08|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.08|-0.34|0.302
71860341|NCT04367480|143235345|SUPERIORITY||Mean Difference (Final Values)|1.37|STANDARD_ERROR_OF_MEAN|0.85||0.112|TWO_SIDED|95.0|-0.33|3.08|||ANCOVA|||Subgroup analysis on participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22)||3.08|-0.33|0.112
71860342|NCT04367480|143235346|SUPERIORITY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.35||0.351|TWO_SIDED|95.0|-0.37|1.02|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.02|-0.37|0.351
71860343|NCT04367480|143235346|SUPERIORITY||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.78||0.128|TWO_SIDED|95.0|-0.36|2.79|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23)||2.79|-0.36|0.128
71860344|NCT04367480|143235347|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.38||0.166|TWO_SIDED|95.0|-0.22|1.27|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.27|-0.22|0.166
71860345|NCT04367480|143235347|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.39||0.492|TWO_SIDED|95.0|-0.51|1.05|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50)||1.05|-0.51|0.492
71860346|NCT04367480|143235348|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.38||0.622|TWO_SIDED|95.0|-0.56|0.94|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||0.94|-0.56|0.622
71860347|NCT04367480|143235348|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.43||0.587|TWO_SIDED|95.0|-0.61|1.08|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50)||1.08|-0.61|0.587
71860348|NCT04367480|143235349|SUPERIORITY||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-0.02|1.31|||ANCOVA|||Analysis on the Study Completers (N: Active TENS=67, Placebo TENS=62)||1.31|-0.02|0.058
71860349|NCT04367480|143235349|SUPERIORITY||Mean Difference (Final Values)|1.35|STANDARD_ERROR_OF_MEAN|0.82||0.11|TWO_SIDED|95.0|-0.32|3.02|||ANCOVA|||Subgroup analysis was performed on participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18)||3.02|-0.32|0.110
71882346|NCT00135668|143283674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.0|STANDARD_DEVIATION|12.88|<|0.001|TWO_SIDED|95.0|-20.7|-13.3|||t-test, 2 sided|Paired t-test.||||-13.30|-20.70|<0.001
71882347|NCT00135668|143283674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_DEVIATION|15.95|<|0.001|TWO_SIDED|95.0|-24.38|-15.58|||t-test, 2 sided|Paired t-test.||||-15.58|-24.38|<0.001
71882348|NCT00135668|143283674|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.6|STANDARD_DEVIATION|18.63|<|0.001|TWO_SIDED|95.0|-21.87|-11.39|||t-test, 2 sided|Paired t-test||||-11.39|-21.87|<0.001
71907024|NCT03172481|143336042|OTHER|The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom SKAMP-C scores from each time point as the dependent variable. The repeated measures model adjusted means (LS-means) for PRC-063 and placebo were compared statistically using a t-test with an overall 5% significance level to evaluate efficacy. The LS-means estimate an overall treatment effect across the entire 13-hour classroom evaluation.|||||<|0.0001|||||||ANOVA|||||||<0.0001
71907025|NCT01061736|143336068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.1155|TWO_SIDED|95.0|0.85|4.64||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.||4.64|0.85|0.1155
71907026|NCT01061736|143336068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.84||||0.0041|TWO_SIDED|95.0|1.53|9.63||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||9.63|1.53|0.0041
71907027|NCT01061736|143336068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.7119|TWO_SIDED|95.0|0.52|2.61||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||2.61|0.52|0.7119
71907028|NCT01061736|143336068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0363|TWO_SIDED|95.0|1.06|5.35||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.35|1.06|0.0363
71907029|NCT01061736|143336068|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34||||0.0426|TWO_SIDED|95.0|1.03|5.29||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||||5.29|1.03|0.0426
71907030|NCT01061736|143336069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.773|||<|0.0001|TWO_SIDED|95.0|2.077|3.703||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo was derived. The multiplicity issues for part B were addressed by using a Bonferroni correction for each dose together with a hierarchical testing procedure across the 3 co-primary and the main secondary endpoints. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.||3.703|2.077|<0.0001
71681395|NCT00772005|142881227|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6907
71907031|NCT01061736|143336069|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.975|||<|0.0001|TWO_SIDED|95.0|2.957|5.344||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||5.344|2.957|<0.0001
71907032|NCT01061736|143336070|SUPERIORITY_OR_OTHER||LS mean difference|-0.235|||<|0.0001|TWO_SIDED|95.0|-0.312|-0.157||Threshold for significance = 0.025.|Mixed Models Analysis|||Analysis was performed using a mixed model for repeated measures (MMRM). Differences in least square (LS) mean between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoint was statistically significant).||-0.157|-0.312|<0.0001
71907033|NCT01061736|143336070|SUPERIORITY_OR_OTHER||LS mean difference|-0.258|||<|0.0001|TWO_SIDED|95.0|-0.336|-0.181||Threshold for significance = 0.025.|Mixed Models Analysis|||||-0.181|-0.336|<0.0001
71907034|NCT01061736|143336071|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||Analysis was performed using two-sided rank-based ANCOVA model. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||||<0.0001
71681396|NCT00772005|142881228|SUPERIORITY_OR_OTHER|||||||0.2518||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.2518
71860350|NCT00634842|143235356|NON_INFERIORITY_OR_EQUIVALENCE|The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \< 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|1.86||||0.0411||95.0|1.03|3.37|||Test for Difference in Proportions|||To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.||3.37|1.03|0.0411
71860351|NCT00634842|143235357|NON_INFERIORITY_OR_EQUIVALENCE|The hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level \<= 6.5% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|2.34||||0.0064||95.0|1.27|4.3|||Regression, Logistic|||||4.30|1.27|0.0064
71860352|NCT00634842|143235358|SUPERIORITY_OR_OTHER||LSMean|-0.271||||0.0019||95.0|-0.441|-0.101|||ANCOVA|The analyses for HbA1c were adjusted for baseline HbA1c values.||||-0.101|-0.441|0.0019
71860353|NCT01642147|143235360|SUPERIORITY_OR_OTHER|||||||0.554||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||0.554
71860354|NCT01642147|143235361|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
71907035|NCT01061736|143336071|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||||||<0.0001
71922026|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||13.7|0.2|
71860355|NCT01642147|143235362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
71860356|NCT01642147|143235363|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
71860357|NCT01642147|143235364|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
71860358|NCT01642147|143235365|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"||||<0.001
71860359|NCT01407276|143235402|SUPERIORITY_OR_OTHER||GMR|0.94|||||TWO_SIDED|90.0|0.8|1.11|||Geometric mean ratio (GMR)|GMR of Panel A:Panel B||||1.11|0.80|
71860360|NCT01407276|143235402|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.34|||||TWO_SIDED|90.0|1.12|1.61|||GMR of Panel C:Panel D|||||1.61|1.12|
71907036|NCT01061736|143336072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.661|||<|0.0001|TWO_SIDED|95.0|2.451|8.863||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).||8.863|2.451|<0.0001
71907037|NCT01061736|143336072|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.565|||<|0.0001|TWO_SIDED|95.0|2.946|10.515||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||||10.515|2.946|<0.0001
71907038|NCT01093755|143336073|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.30
71907039|NCT01093755|143336073|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.52
71860361|NCT01407276|143235402|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.56|||||TWO_SIDED|90.0|1.32|1.85|||GMR of Panel E:Panel F|||||1.85|1.32|
71907040|NCT01093755|143336074|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months||||0.70
71907041|NCT01093755|143336074|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months||||0.64
71907042|NCT01295580|143336158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)~Alpha inflation was controlled using pre-planned stepwise hypotheses testing (1) WOMAC Pain over 18 weeks then (2) over 26 weeks, (3) WOMAC Physical Function over 18 weeks then (4) over 26 weeks, (5) Subject Global Assessment over 18 weeks then (6) over 26 weeks, (7) WOMAC Knee Stiffness over 18 weeks then (8) over 26 weeks."|Mean Difference (Final Values)|-0.09|||||TWO_SIDED|95.0|-0.58|0.39||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the first step WOMAC pain over 18 week pain subscale primary analyses.||The second step is to test Durolane WOMAC pain non-inferior to Artz WOMAC pain over 26 weeks.||"Primary Hypothesis:~Ho: μDUR\[18\] - μArtz\[18\] ≥ +1.6 units Ha: μDUR\[18\] - μArtz\[18\] \< +1.6 units~Power Calculations:~Assume the over 18 weeks difference is 0mm, SD 20mm (5 on the Likert scale), 90% power, 2-sided test alpha 5%, and a 8mm non-inferiority margin (1.6 on the Likert scale), the sample size required is 132 subjects per group adjusted to 175 to hold power constant due to loss to follow-up and dropout."||0.39|-0.58|
71922027|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|-1.7|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 4, pre-dose AM||11.8|-1.7|
71860362|NCT01407276|143235402|SUPERIORITY_OR_OTHER||GMR or Panel G:Panel H|1.89|||||TWO_SIDED|90.0|1.4|2.55|||GMR of Panel G:Panel H|||||2.55|1.40|
71860363|NCT01407276|143235402|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.97|||||TWO_SIDED|90.0|1.46|2.66|||GMR of Panel G:Panel H|||||2.66|1.46|
71860364|NCT01407276|143235403|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.94|||||TWO_SIDED|90.0|0.79|1.12|||GMR of Panel A:Panel B|||||1.12|0.79|
71860365|NCT01407276|143235403|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.13|||||TWO_SIDED|90.0|0.91|1.41|||GMR of Panel C:Panel D|||||1.41|0.91|
71860366|NCT01407276|143235403|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.9|||||TWO_SIDED|90.0|0.66|1.23|||GMR of Panel E:Panel F|||||1.23|0.66|
71860367|NCT01407276|143235403|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.74|||||TWO_SIDED|90.0|0.57|0.96|||GMR of Panel E:Panel F|||||0.96|0.57|
71860368|NCT01407276|143235403|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.73|||||TWO_SIDED|90.0|0.56|0.95|||GMR of Panel E:Panel F|||||0.95|0.56|
71860369|NCT01407276|143235404|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.81|1.05|||GMR of Panel A:Panel B|||||1.05|0.81|
71860370|NCT01407276|143235404|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.33||||||90.0|1.07|1.65|||GMR of Panel C:Panel D|||||1.65|1.07|
71860371|NCT01407276|143235404|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.37|||||TWO_SIDED|90.0|1.13|1.65|||GMR of Panel E:Panel F|||||1.65|1.13|
71860372|NCT01407276|143235404|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.38|||||TWO_SIDED|90.0|1.06|1.79|||GMR of Panel G:Panel H|||||1.79|1.06|
71860373|NCT01407276|143235404|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.3|||||TWO_SIDED|90.0|1.0|1.68|||GMR of Panel G:Panel H|||||1.68|1.00|
71860374|NCT01407276|143235405|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.92|||||TWO_SIDED|90.0|0.75|1.12|||GMR of Panel A:Panel B|||||1.12|0.75|
71860375|NCT01407276|143235405|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|1.45|||||TWO_SIDED|90.0|1.19|1.76|||GMR of Panel C:Panel D|||||1.76|1.19|
71860376|NCT01407276|143235405|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|1.83|||||TWO_SIDED|90.0|1.49|2.24|||GMR of Panel E:Panel F|||||2.24|1.49|
71860377|NCT01407276|143235405|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.9|||||TWO_SIDED|90.0|1.41|2.54|||GMR of Panel G:Panel H|||||2.54|1.41|
71681397|NCT00772005|142881228|SUPERIORITY_OR_OTHER|||||||0.0739||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0739
71681398|NCT00772005|142881228|SUPERIORITY_OR_OTHER|||||||0.5644||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5644
71860378|NCT01407276|143235405|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|1.88|||||TWO_SIDED|90.0|1.4|2.52|||GMR of Panel G:Panel H|||||2.52|1.40|
71860379|NCT01407276|143235406|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.11|||||TWO_SIDED|90.0|0.87|1.42|||GMR of Panel A:Panel B|||||1.42|0.87|
71860380|NCT01407276|143235406|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.53|1.07|||GMR of Panel C:Panel D|||||1.07|0.53|
71860381|NCT01407276|143235406|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.68|||||TWO_SIDED|90.0|0.51|0.92|||GMR of Panel E:Panel F|||||0.92|0.51|
71860382|NCT01407276|143235406|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.7|||||TWO_SIDED|90.0|0.5|0.98|||GMR of Panel G:Panel H|||||0.98|0.50|
71860383|NCT01407276|143235406|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.8|||||TWO_SIDED|90.0|0.57|1.12|||GMR of Panel G:Panel H|||||1.12|0.57|
71860384|NCT01407276|143235407|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|1.06|||||TWO_SIDED|90.0|0.9|1.25|||GMR of Panel A:Panel B|||||1.25|0.90|
71860385|NCT01407276|143235407|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.75|||||TWO_SIDED|90.0|0.62|0.89|||GMR of Panel C:Panel D|||||0.89|0.62|
71860386|NCT01407276|143235407|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.64|||||TWO_SIDED|90.0|0.54|0.76|||GMR of Panel E:Panel F|||||0.76|0.54|
71860387|NCT01407276|143235407|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.53|||||TWO_SIDED|90.0|0.39|0.71|||GMR of Panel G:Panel H|||||0.71|0.39|
71860388|NCT01407276|143235407|SUPERIORITY_OR_OTHER||GMR of Panel G:Panel H|0.51|||||TWO_SIDED|90.0|0.38|0.68|||GMR of Panel G:Panel H|||||0.68|0.38|
71860389|NCT01407276|143235408|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.93|||||TWO_SIDED|90.0|0.74|1.18|||GMR of Panel A:Panel B|||||1.18|0.74|
71860390|NCT01407276|143235408|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.73|||||TWO_SIDED|90.0|0.55|0.96|||GMR of Panel C:Panel D|||||0.96|0.55|
71860391|NCT01407276|143235408|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.42|||||TWO_SIDED|90.0|0.33|0.54|||GMR of Panel E:Panel F|||||0.54|0.33|
71860392|NCT01407276|143235409|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
71860393|NCT01407276|143235409|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
71860394|NCT01407276|143235409|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
71860395|NCT01407276|143235410|SUPERIORITY_OR_OTHER||GMR of Panel A:Panel B|0.86|||||TWO_SIDED|90.0|0.69|1.07|||GMR of Panel A:Panel B|||||1.07|0.69|
71860396|NCT01407276|143235410|SUPERIORITY_OR_OTHER||GMR of Panel C:Panel D|0.9|||||TWO_SIDED|90.0|0.7|1.15|||GMR of Panel C:Panel D|||||1.15|0.70|
71860397|NCT01407276|143235410|SUPERIORITY_OR_OTHER||GMR of Panel E:Panel F|0.5|||||TWO_SIDED|90.0|0.37|0.67|||GMR of Panel E:Panel F|||||0.67|0.37|
71860398|NCT01174264|143235436|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.75||||0.003|TWO_SIDED|90.0|1.3|2.34|||t-test, 2 sided|Performed on log-transformed data.||||2.34|1.30|0.003
71860399|NCT01174264|143235436|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.08||||0.65|TWO_SIDED|90.0|0.81|1.44||Performed on log-transformed data.|t-test, 2 sided|||||1.44|0.81|0.65
71860400|NCT01174264|143235437|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.74||||0.008|TWO_SIDED|90.0|1.25|2.42|||t-test, 2 sided|Performed on log-transformed data.||||2.42|1.25|0.008
71860401|NCT01174264|143235437|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12||||0.51|TWO_SIDED|90.0|0.84|1.49|||t-test, 2 sided|Performed on log-transformed data.||||1.49|0.84|0.51
71860402|NCT01174264|143235439|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
71860403|NCT01174264|143235439|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
71860404|NCT01174264|143235440|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71860405|NCT01174264|143235440|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71860406|NCT01174264|143235441|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.16||||0.17|TWO_SIDED|90.0|0.97|1.38|||t-test, 2 sided|Performed on log-transformed data.||||1.38|0.97|0.17
71860407|NCT01174264|143235442|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.13||||0.25|TWO_SIDED|90.0|0.95|1.35|||t-test, 2 sided|Performed on log-transformed data.||||1.35|0.95|0.25
71860408|NCT01174264|143235443|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.22||||0.096|TWO_SIDED|90.0|1.0|1.48||Performed on log-transformed data.|t-test, 2 sided|||||1.48|1.00|0.096
71860409|NCT01174264|143235444|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.27
71882349|NCT04341441|143283735|SUPERIORITY|Sample size was determined with one planned interim analysis when 50% of participants had completed their 8 weeks of treatment using an O'Brien-Fleming alpha spending method to ensure an overall type 1 error of 0.05. With a sample size of 900 per group and alpha = 0.0492, the power to detect a 32% reduction in COVID-19 disease rate (10% vs 6.8%) between the placebo and HCQ treated groups, determined at 87%. Study required 1000 per group with a total of 3000 patients to complete the trial.|Risk Ratio (RR)|0.32||||0.75|TWO_SIDED|||||P-value for the comparison between groups, including the non-randomized active comparator, was 0.75.|Mantel Haenszel||Low number of primary events precluded estimated value of risk ratio.|||||0.75
71681399|NCT00772005|142881229|SUPERIORITY_OR_OTHER|||||||0.4305||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4305
71681400|NCT00772005|142881229|SUPERIORITY_OR_OTHER|||||||0.8299||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8299
71681401|NCT00772005|142881229|SUPERIORITY_OR_OTHER|||||||0.7283||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7283
71882350|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||All sites combined (week 6) - Between-group differences of mean in LBP||-0.7|-1.4|
71882351|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-1.2|-0.5||||||All sites combined (week 12) - Between-group differences of mean in LBP||-0.5|-1.2|
71882352|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.1||||||Walter Reed site (week 6) - Between-group differences of mean in LBP||-0.1|-1.3|
71882353|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2||||||Walter Reed site (week 12) - Between-group differences of mean in LBP||0.2|-1.0|
71882354|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.8|-0.6||||||Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP||-0.6|-1.8|
71882355|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.8|-0.5||||||Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP||-0.5|-1.8|
71882356|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-1.9|-0.8||||||Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP||-0.8|-1.9|
71882357|NCT01692275|143283748|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.7|-0.5||||||Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP||-0.5|-1.7|
71882358|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-3.1|-1.2||||||All sites combined (week 6) - RMDQ Between-Group Differences in Disability||-1.2|-3.1|
71882359|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|95.0|-3.0|-1.0||||||All sites combined (week 12) - RMDQ Between-Group Differences in Disability||-1.0|-3.0|
71882360|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-3.4|-0.2||||||Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability||-0.2|-3.4|
71882361|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.2|0.2||||||Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability||0.2|-3.2|
71882362|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.8|-0.4||||||Pensacola site (week 6) - RMDQ Between-Group Differences in Disability||-0.4|-3.8|
71882363|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-1.9|||||TWO_SIDED|95.0|-3.7|-0.2||||||Pensacola site (week 12) - RMDQ Between-Group Differences in Disability||-0.2|-3.7|
71882364|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.3|-1.1||||||San Diego site (week 6) - RMDQ Between-Group Differences in Disability||-1.1|-4.3|
71882365|NCT01692275|143283749|SUPERIORITY||Mean Difference (Final Values)|-2.7|||||TWO_SIDED|95.0|-4.4|-1.1||||||San Diego site (week 12) - RMDQ Between-Group Differences in Disability||-1.1|-4.4|
71882366|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
71882367|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.6|-0.2||||||All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.6|
71882368|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
71882369|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||0.1|-0.5|
71882370|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
71882371|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.8|-0.2||||||Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.8|
71882372|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.7|-0.2||||||San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.2|-0.7|
71882373|NCT01692275|143283750|SUPERIORITY||Mean Difference (Final Values)|-0.4|||||TWO_SIDED|95.0|-0.7|-0.1||||||San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP||-0.1|-0.7|
71907043|NCT01295580|143336159|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +1.6 units corresponds to an 8% margin on the pain subscale (range 0-20)|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.56|0.37||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first pain over 18 weeks then pain over 26 weeks. This section reports the over 26 week pain subscale results.||The third ordered test is Durolane WOMAC physical function subscale non-inferior to Artz WOMAC physical function subscale over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +1.6 units Ha: μDUR\[26\] - μArtz\[26\] \< +1.6 units||0.37|-0.56|
71907044|NCT01295580|143336160|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.65|||||TWO_SIDED|95.0|-1.81|0.51||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week physical function results.||The fourth step is to test Durolane WOMAC physical function non-inferior to Artz physical function over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +5.44 units Ha: μDUR\[18\] - μArtz\[18\] \< +5.44 units||0.51|-1.81|
71907045|NCT01295580|143336161|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +5.44 units corresponds to an 8% margin on the physical function subscale (range 0-68).|Mean Difference (Final Values)|-0.58|||||TWO_SIDED|95.0|-1.69|0.53||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week physical function subscale results.||The fifth step is to test Durolane subject global assessment non-inferior to Artz global assessment over 18 weeks.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +5.44 units Ha: μDUR\[26\] - μArtz\[26\] \< +5.44 units||0.53|-1.69|
71907046|NCT01295580|143336162|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.15|0.45||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week subject global assessment results.||The sixth step is to test Durolane subject global assessment non-inferior to Artz subject global assessment over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.45|-0.15|
71922028|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.1|9.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||9.0|-3.1|
71922029|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.6|STANDARD_ERROR_OF_MEAN|2.9|||TWO_SIDED|95.0|-3.4|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 5, pre-dose AM||8.7|-3.4|
71681402|NCT00772005|142881230|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7610
71681403|NCT00772005|142881230|SUPERIORITY_OR_OTHER|||||||0.6091||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6091
71681404|NCT00772005|142881230|SUPERIORITY_OR_OTHER|||||||0.3368||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.3368
71882374|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.6|-0.8||||||All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-1.6|
71882375|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|95.0|-1.6|-0.7||||||All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-1.6|
71882376|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.3|-0.02||||||Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.02|-1.3|
71882377|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-0.8|||||TWO_SIDED|95.0|-1.5|-0.1||||||Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.1|-1.5|
71882378|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-2.0|-0.7||||||Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.7|-2.0|
71882379|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-2.3|-0.8||||||Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.8|-2.3|
71882380|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.3|-1.0||||||San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-1.0|-2.3|
71882381|NCT01692275|143283751|SUPERIORITY||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-1.9|-0.5||||||San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean||-0.5|-1.9|
71882382|NCT01692275|143283752|SUPERIORITY||Odds Ratio (OR)|0.73|||||TWO_SIDED|95.0|0.54|0.97||||||Week 6: All 3 sites combined||0.97|0.54|
71882383|NCT01692275|143283752|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.58|1.0||||||Week 12: All 3 sites combined||1.0|0.58|
71882384|NCT01692275|143283753|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.13|0.25||||||All sites combined: 6 weeks||0.25|0.13|
71882385|NCT01692275|143283753|SUPERIORITY||Odds Ratio (OR)|0.26|||||TWO_SIDED|95.0|0.16|0.42||||||Walter Reed site: 6 weeks||0.42|0.16|
71882386|NCT01692275|143283753|SUPERIORITY||Odds Ratio (OR)|0.18|||||TWO_SIDED|95.0|0.1|0.33||||||Naval Hospital Pensacola site: 6 weeks||0.33|0.10|
71882387|NCT01692275|143283753|SUPERIORITY||Odds Ratio (OR)|0.13|||||TWO_SIDED|95.0|0.08|0.21||||||Naval Medical Center San Diego site: 6 weeks||0.21|0.08|
71882388|NCT01692275|143283754|SUPERIORITY||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|2.1|2.8||||||All sites combined: 6 weeks||2.8|2.1|
71882389|NCT01692275|143283754|SUPERIORITY||Mean Difference (Final Values)|2.0|||||TWO_SIDED|95.0|1.4|2.6||||||Walter Reed site: 6 weeks||2.6|1.4|
71681405|NCT00772005|142881231|SUPERIORITY_OR_OTHER|||||||0.8457||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8457
71882390|NCT01692275|143283754|SUPERIORITY||Mean Difference (Final Values)|2.3|||||TWO_SIDED|95.0|1.6|3.0||||||Naval Hospital Pensacola site: 6 weeks||3.0|1.6|
71882391|NCT01692275|143283754|SUPERIORITY||Mean Difference (Final Values)|3.1|||||TWO_SIDED|95.0|2.5|3.7||||||Naval Medical Center San Diego site: 6 weeks||3.7|2.5|
71882392|NCT02813551|143283757|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.53|1.1||||||||1.10|0.53|
71882393|NCT02813551|143283758|SUPERIORITY||Risk Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.3||||||||3.3|0.4|
71882394|NCT02813551|143283759|SUPERIORITY||Risk Ratio (RR)|3.0|||||TWO_SIDED|95.0|0.3|28.0||||||||28|0.3|
71882395|NCT02813551|143283760|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.3||||||||1.3|1.0|
71882396|NCT02813551|143283763|SUPERIORITY||Risk Ratio (RR)|1.1|||||TWO_SIDED|95.0|1.0|1.2||||||||1.2|1.0|
71882397|NCT02813551|143283764|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|1.9||||||||1.9|0.5|
71882398|NCT02813551|143283765|SUPERIORITY||Risk Ratio (RR)|0.4|||||TWO_SIDED|95.0|0.1|2.9||||||||2.9|0.1|
71882399|NCT04649255|143283781|OTHER||Exact binomial|96.4|||<|0.025|TWO_SIDED|95.0|96.4|100.0|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: Ps ≤ PGS, versus HA: PS \> PGS, where where Ps is the population primary safety success rate in the Test group and PGS is the safety performance goal of 82%.||100|96.4|<0.025
71882400|NCT04649255|143283782|OTHER||Exact binomial|89.1|||<|0.025|TWO_SIDED|95.0|89.1|97.5|||One-sided exact binomial test|Exact binomial one-sided lower 97.5% CI for performance goal test \>72% for primary effectiveness and \>82% for primary safety.||Descriptive assessment; H0: PE ≤ PGE, versus HA: PE \> PGE, where PE is the proportion of target lesions with clinical success and PGE is the effectiveness performance goal of 72%.||97.5|89.1|<0.025
71681406|NCT00772005|142881231|SUPERIORITY_OR_OTHER|||||||0.4531||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.4531
71681407|NCT00772005|142881231|SUPERIORITY_OR_OTHER|||||||0.6867||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.6867
71860410|NCT00267098|143235470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.729||||0.999|TWO_SIDED|95.0|0.592|0.889||BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.||0.889|0.592|0.9990
71860411|NCT00267098|143235471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.843||||0.865|TWO_SIDED|95.0|0.632|1.142||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.||1.142|0.632|0.865
71860412|NCT00267098|143235472|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.781||||0.9785|TWO_SIDED|95.0|0.615|0.991||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.||0.991|0.615|0.9785
71860413|NCT00267098|143235473|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.695||||0.9886|TWO_SIDED|95.0|0.558|0.866||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing."||0.866|0.558|0.9886
71882401|NCT01908101|143283871|OTHER|comparison analysis|Median Difference (Final Values)|3.5|||||TWO_SIDED|95.0|2.6|4.6||comparison analysis; no P value|||The estimated value is 3.5 months, not years.|Progression free survival (PFS). We hypothesize that metronomic dosing of eribulin will result in a PFS of 4-6 months.||4.6|2.6|
71882402|NCT00166205|143283872|SUPERIORITY_OR_OTHER||Percent of ITT subjects|69.6||||||95.0|63.8|74.9||||||A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.||74.9|63.8|
71882403|NCT00166205|143283873|SUPERIORITY_OR_OTHER||Mean|75.7|STANDARD_DEVIATION|39.8||||95.0|70.5|80.8||||||||80.8|70.5|
71882404|NCT00166205|143283874|SUPERIORITY_OR_OTHER||Mean|35.7|STANDARD_DEVIATION|6.2||||95.0|34.9|36.5||||||||36.5|34.9|
71882405|NCT00166205|143283875|SUPERIORITY_OR_OTHER||Mean|51.3|STANDARD_DEVIATION|45.8||||95.0|47.6|54.9||||||||54.9|47.6|
71907047|NCT01295580|143336163|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of -0.8 units corresponds to an 8% margin on the subject global assessment (range 0-10). Note that because the assessment interpretation is reversed as compared to the WOMAC assessments the lower bound of the 95%CI is compared to the -0.8 non-inferiority margin.|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-0.16|0.43||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week subject global assessment results.||The seventh step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 18 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≤ -0.8 units Ha: μDUR\[18\] - μArtz\[18\] \> -0.8 units||0.43|-0.16|
71922030|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.4|10.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||10.0|-5.4|
71681408|NCT00772005|142881232|SUPERIORITY_OR_OTHER|||||||0.9705||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9705
71860414|NCT00267098|143235474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.704||||0.9904|TWO_SIDED|95.0|0.522|0.947||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.||0.947|0.522|0.9904
71860415|NCT00267098|143235475|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-1.8||||0.637||||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Difference in Average Ranks|The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.|The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.||||0.637
71860416|NCT00267098|143235476|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.012||||0.591|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.591
71860417|NCT00267098|143235476|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.126||||0.986|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.986
71860418|NCT00267098|143235476|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.039||||0.726|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.726
71882406|NCT00166205|143283876|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4|STANDARD_DEVIATION|10.3||||95.0|9.2|11.7|||||Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)|||11.7|9.2|
71882407|NCT00166205|143283877|SUPERIORITY_OR_OTHER||Mean|5.7|STANDARD_DEVIATION|0.7||||95.0|5.6|5.8||||||||5.8|5.6|
71882408|NCT00166205|143283879|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.||||<0.001
71882409|NCT00166205|143283880|SUPERIORITY_OR_OTHER||Mean|56.4|STANDARD_DEVIATION|14.7||||95.0|54.5|58.4||||||||58.4|54.5|
71681409|NCT00772005|142881232|SUPERIORITY_OR_OTHER|||||||0.0021||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0021
71681410|NCT00772005|142881232|SUPERIORITY_OR_OTHER|||||||0.5013||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.5013
71882410|NCT00166205|143283881|SUPERIORITY_OR_OTHER||Mean|114.5|STANDARD_DEVIATION|32.3||||95.0|110.1|118.8||||||||118.8|110.1|
71882411|NCT00166205|143283882|SUPERIORITY_OR_OTHER||Mean|193.5|STANDARD_DEVIATION|36.9||||95.0|188.6|198.4||||||||198.4|188.6|
71882412|NCT03882970|143283890|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.86|||<|0.001|TWO_SIDED|95.0|-1.0|-0.72|||Mixed Models Analysis|||||-0.72|-1.00|<0.001
71860419|NCT00267098|143235476|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.035||||0.701|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.701
71860420|NCT00267098|143235477|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.002||||0.534|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.534
71860421|NCT00267098|143235477|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.026||||0.825|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.825
71860422|NCT00267098|143235477|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|0.01||||0.651|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote that the BiV arm had better outcomes over time than the RV arm.|Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.651
71860423|NCT00267098|143235477|SUPERIORITY_OR_OTHER||BiV - RV Difference in Average Rank|-0.006||||0.425|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.||||0.425
71860424|NCT00267098|143235481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.9976|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing."||||0.9976
71882413|NCT03882970|143283890|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.17|-0.9|||Mixed Models Analysis|||||-0.90|-1.17|<0.001
71882414|NCT03882970|143283891|NON_INFERIORITY|The study was powered for superiority in HbA1c. The sample size provided \>99% power to show noninferiority assuming a 0.3% NI boundary, 0.35% greater mean reduction in tirzepatide doses compared to insulin degludec, 1:1:1:1 randomization, a common SD of 1.1%, 1 sided significance level of 0.0125, and a dropout rate of 28%.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.73|-0.45|||Mixed Models Analysis|||||-0.45|-0.73|<0.001
71882415|NCT03882970|143283892|SUPERIORITY||LS Mean Difference|-9.8|||<|0.001|TWO_SIDED|95.0|-10.8|-8.8|||Mixed Models Analysis|||||-8.8|-10.8|<0.001
71882416|NCT03882970|143283892|SUPERIORITY||LS Mean Difference|-13.0|||<|0.001|TWO_SIDED|95.0|-14.0|-11.9|||Mixed Models Analysis|||||-11.9|-14.0|<0.001
71882417|NCT03882970|143283892|SUPERIORITY||LS Mean Difference|-15.2|||<|0.001|TWO_SIDED|95.0|-16.2|-14.2|||Mixed Models Analysis|||||-14.2|-16.2|<0.001
71882418|NCT03882970|143283893|SUPERIORITY||LS Mean Difference|7.5||||0.004|TWO_SIDED|95.0|2.4|12.5|||Mixed Models Analysis|||||12.5|2.4|0.004
71882419|NCT03882970|143283893|SUPERIORITY||LS Mean Difference|0.8||||0.751|TWO_SIDED|95.0|-4.3|5.9|||Mixed Models Analysis|||||5.9|-4.3|0.751
71882420|NCT03882970|143283893|SUPERIORITY||LS Mean Difference|-3.6||||0.168|TWO_SIDED|95.0|-8.7|1.5|||Mixed Models Analysis|||||1.5|-8.7|0.168
71882421|NCT03882970|143283894|SUPERIORITY||Odds Ratio (OR)|3.45|||<|0.001|TWO_SIDED|95.0|2.38|5.01|||Regression, Logistic|||||5.01|2.38|<0.001
71882422|NCT03882970|143283894|SUPERIORITY||Odds Ratio (OR)|7.02|||<|0.001|TWO_SIDED|95.0|4.55|10.84|||Regression, Logistic|||||10.84|4.55|<0.001
71860425|NCT00267098|143235482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.9641|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing."||||0.9641
71860426|NCT00267098|143235483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.8416|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing."||||0.8416
71860427|NCT00267098|143235484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.727|TWO_SIDED|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing."||||0.7270
71860428|NCT00267098|143235485|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.334|||||TWO_SIDED|95.0|1.886|4.815||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 6 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing."||4.815|1.886|
71860429|NCT00267098|143235486|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.232|||||TWO_SIDED|95.0|1.618|4.839||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 12 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.||4.839|1.618|
71882423|NCT03882970|143283894|SUPERIORITY||Odds Ratio (OR)|10.79|||<|0.001|TWO_SIDED|95.0|6.65|17.48|||Regression, Logistic|||||17.48|6.65|<0.001
71882424|NCT03882970|143283896|SUPERIORITY||Odds Ratio (OR)|29.78|||<|0.001|TWO_SIDED|95.0|18.35|48.35|||Regression, Logistic|||||48.35|18.35|<0.001
71882425|NCT03882970|143283896|SUPERIORITY||Odds Ratio (OR)|79.88|||<|0.001|TWO_SIDED|95.0|47.56|134.17|||Regression, Logistic|||||134.17|47.56|<0.001
71882426|NCT03882970|143283896|SUPERIORITY||Odds Ratio (OR)|110.77|||<|0.001|TWO_SIDED|95.0|64.73|189.55|||Regression, Logistic|||||189.55|64.73|<0.001
71882427|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|-0.26||||0.096|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Hyperglycemia||0.05|-0.57|0.096
71882428|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|-0.25||||0.113|TWO_SIDED|95.0|-0.57|0.06|||ANCOVA|||Hyperglycemia||0.06|-0.57|0.113
71882429|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|-0.47||||0.003|TWO_SIDED|95.0|-0.78|-0.16|||ANCOVA|||Hyperglycemia||-0.16|-0.78|0.003
71882430|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|-0.41||||0.014|TWO_SIDED|95.0|-0.74|-0.08|||ANCOVA|||Hypoglycemia||-0.08|-0.74|0.014
71681411|NCT00772005|142881233|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.7330
71882431|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|-0.18||||0.28|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Hypoglycemia||0.15|-0.51|0.280
71882432|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|-0.26||||0.129|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Hypoglycemia||0.07|-0.59|0.129
71882433|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|3.01|||<|0.001|TWO_SIDED|95.0|2.26|3.75|||ANCOVA|||Treatment Satisfaction Score||3.75|2.26|<0.001
71882434|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.15|3.65|||ANCOVA|||Treatment Satisfaction Score||3.65|2.15|<0.001
71907048|NCT01295580|143336164|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of +0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.14|||||TWO_SIDED|95.0|-0.33|0.05||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 18 week knee stiffness subscale results.||The eight and last step is to test Durolane WOMAC knee stiffness non-inferior to Artz WOMAC knee stiffness over 26 weeks.||Ho: μDUR\[18\] - μArtz\[18\] ≥ +0.64 units Ha: μDUR\[18\] - μArtz\[18\] \< +0.64 units||0.05|-0.33|
71907049|NCT01295580|143336165|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This is a non-inferiority test. The non-inferiority margin of 0.64 units corresponds to an 8% margin on the knee stiffness subscale (range 0-8).|Mean Difference (Final Values)|-0.15|||||TWO_SIDED|95.0|-0.33|0.03||Alpha inflation due to multiple testing was controlled using preplanned ordered stepwise hypothesis testing first over 18 weeks then over 26 weeks. This section reports the over 26 week knee stiffness subscale results.||This is the eighth and last pre-planned hypothesis test.||Ho: μDUR\[26\] - μArtz\[26\] ≥ +0.64 units Ha: μDUR\[26\] - μArtz\[26\] \< +0.64 units||0.03|-0.33|
71907050|NCT01397448|143336264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.11|||<|0.001|TWO_SIDED|95.0|0.04|0.31|||Log Rank|||||0.31|0.04|<0.001
71907051|NCT01397448|143336264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.05|||<|0.001|TWO_SIDED|95.0|0.01|0.23|||Log Rank|||||0.23|0.01|<0.001
71907052|NCT02180217|143336265|OTHER||Odds Ratio (OR)|13.71|||<|0.001|TWO_SIDED|95.0|3.73|53.44|||Cochran-Mantel-Haenszel|||||53.44|3.73|<.001
71681412|NCT00772005|142881233|SUPERIORITY_OR_OTHER|||||||0.0068||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0068
71681413|NCT00772005|142881233|SUPERIORITY_OR_OTHER|||||||0.104||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.1040
71907053|NCT02475395|143336326|OTHER||Sensitivity|90.0|||||TWO_SIDED|95.0|79.9|95.3|||||Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.|||95.3|79.9|
71907054|NCT02475395|143336326|OTHER||Specificity|93.3|||||TWO_SIDED|95.0|88.7|96.1|||||Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.|||96.1|88.7|
71907055|NCT02475395|143336327|OTHER||Sensitivity|95.0|||||TWO_SIDED|95.0|86.3|98.3||||||||98.3|86.3|
71907056|NCT02475395|143336327|OTHER||Specificity|94.9|||||TWO_SIDED|95.0|90.6|97.3||||||||97.3|90.6|
71907057|NCT02475395|143336328|OTHER||Sensitivity|96.7|||||TWO_SIDED|95.0|88.7|99.1||||||||99.1|88.7|
71907058|NCT02475395|143336328|OTHER||Specificity|93.8|||||TWO_SIDED|95.0|89.2|96.5||||||||96.5|89.2|
71922031|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.4|7.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 6, pre-dose AM||7.0|-8.4|
71922032|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.6|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.8|-1.6|
71922033|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.0|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.7|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, pre-dose AM||11.7|-1.7|
71922034|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-1.6|20.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||20.2|-1.6|
71922035|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|13.0|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|2.1|23.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 1 hour||23.9|2.1|
71922036|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|7.1|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|0.2|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||13.9|0.2|
71922037|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|11.5|STANDARD_ERROR_OF_MEAN|3.3|||TWO_SIDED|95.0|4.6|18.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, post-dose AM 4 hour||18.3|4.6|
71922038|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-4.8|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose AM||8.6|-4.8|
71922039|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|4.1|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-2.6|10.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose||10.8|-2.6|
71922040|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|9.7|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.1|19.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.6|-0.1|
71922041|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|9.6|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-0.3|19.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 1 hour||19.4|-0.3|
71681414|NCT00772005|142881234|SUPERIORITY_OR_OTHER|||||||0.822||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.8220
71860430|NCT00267098|143235487|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|2.24|||||TWO_SIDED|95.0|0.419|4.066||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF at 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.||4.066|0.419|
71860431|NCT00267098|143235488|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|3.623|||||TWO_SIDED|95.0|1.623|5.604||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead, a posterior distribution representing the set of possible values for the BiV - RV difference in improvement in LVEF through 24 months was used|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.||5.604|1.623|
71860432|NCT00267098|143235489|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.204|||||TWO_SIDED|95.0|-10.12|-4.214||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing."||-4.214|-10.12|
71860433|NCT00267098|143235490|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.255|||||TWO_SIDED|95.0|-10.59|-3.829||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.||-3.829|-10.590|
71860434|NCT00267098|143235491|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.242|||||TWO_SIDED|95.0|-11.86|-4.574||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.||-4.574|-11.860|
71860435|NCT00267098|143235492|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-7.268|||||TWO_SIDED|95.0|-11.69|-2.846||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.||-2.846|-11.690|
71882435|NCT03882970|143283897|SUPERIORITY||LS Mean Difference|2.99|||<|0.001|TWO_SIDED|95.0|2.24|3.74|||ANCOVA|||Treatment Satisfaction Score||3.74|2.24|<0.001
71681415|NCT00772005|142881234|SUPERIORITY_OR_OTHER|||||||0.0144||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.0144
71860436|NCT00267098|143235493|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.858|||||TWO_SIDED|95.0|-9.085|-2.562||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.||-2.562|-9.085|
71907059|NCT04390568|143336330|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of the intravenous dose groups.|Slope|1.123|STANDARD_ERROR_OF_MEAN|0.085|||TWO_SIDED|90.0|0.979|1.268|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.268|0.979|
71907060|NCT04390568|143336331|OTHER|The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and the maximum measured concentration of the Spesolimap in plasma (Cmax) of the intravenous dose groups.|Slope|1.072|STANDARD_ERROR_OF_MEAN|0.065|||TWO_SIDED|90.0|0.961|1.183|||||Based on the estimate for slope parameter (β), a 2-sided 90% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|No statistical hypotheses tests were planned for this trial.||1.183|0.961|
71907061|NCT03784027|143336335|SUPERIORITY||Mean Difference (Final Values)|8.7|||<|0.001|TWO_SIDED|95.0|7.4|9.9|||Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||9.9|7.4|<0.001
71907062|NCT03784027|143336336|SUPERIORITY||Mean Difference (Final Values)|-8.5|||<|0.001|TWO_SIDED|95.0|-9.9|-7.1||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-7.1|-9.9|<0.001
71907063|NCT03784027|143336337|SUPERIORITY||Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-0.3|-0.5|<0.001
71907064|NCT03784027|143336338|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED|95.0|-4.9|-2.9|||Mixed Models Analysis|||||-2.9|-4.9|<0.001
71907065|NCT03784027|143336339|SUPERIORITY||Mean Difference (Final Values)|-12.3|||<|0.001|TWO_SIDED|95.0|-14.8|-9.8||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||-9.8|-14.8|<0.001
71907066|NCT03784027|143336340|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.74|TWO_SIDED|95.0|-0.4|0.5||The primary and key secondary end points were tested in hierarchy (Time in range, time \>180mg/dL, HbA1c, mean glucose, time \<70mg/dL) to control the type 1 error with the use of the fixed-sequence method.|Regression, Linear|||||0.5|-0.4|0.74
71907067|NCT03784027|143336341|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-6.2|||||TWO_SIDED|95.0|-7.6|-4.8|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-4.8|-7.6|
71681416|NCT00772005|142881234|SUPERIORITY_OR_OTHER|||||||0.9464||95.0|||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||0.9464
71860437|NCT00267098|143235494|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-5.807|||||TWO_SIDED|95.0|-9.467|-2.038||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing."||-2.038|-9.467|
71882436|NCT05284760|143283915|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|Geometric Mean Ratio (GMR)|97.28|||||TWO_SIDED|90.0|87.66|107.96||||||||107.96|87.66|
71882437|NCT05284760|143283915|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|81.04|||||TWO_SIDED|90.0|73.06|89.89||||||||89.89|73.06|
71882438|NCT05284760|143283915|OTHER||GMR|37.48|||||TWO_SIDED|90.0|31.1|45.17||||||||45.17|31.10|
71882439|NCT05284760|143283915|OTHER||GMR|89.45|||||TWO_SIDED|90.0|74.24|107.79||||||||107.79|74.24|
71882440|NCT05284760|143283916|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|97.52|||||TWO_SIDED|90.0|92.17|103.17||||||||103.17|92.17|
71882441|NCT05284760|143283916|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.88|||||TWO_SIDED|90.0|82.14|91.89||||||||91.89|82.14|
71882442|NCT05284760|143283916|OTHER||GMR|87.63|||||TWO_SIDED|90.0|75.92|101.15||||||||101.15|75.92|
71882443|NCT05284760|143283916|OTHER||GMR|95.49|||||TWO_SIDED|90.0|82.73|110.22||||||||110.22|82.73|
71882444|NCT05284760|143283917|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|99.25|||||TWO_SIDED|90.0|92.84|106.1||||||||106.10|92.84|
71882445|NCT05284760|143283917|EQUIVALENCE|The two treatments were deemed equivalent if the 90% CIs for the GMRs for all of the parameters were each within 80.00% and 125.00%.|GMR|86.98|||||TWO_SIDED|90.0|81.33|93.03||||||||93.03|81.33|
71882446|NCT05284760|143283917|OTHER||GMR|89.28|||||TWO_SIDED|90.0|78.92|100.99||||||||100.99|78.92|
71882447|NCT05284760|143283917|OTHER||GMR|92.77|||||TWO_SIDED|90.0|81.77|105.25||||||||105.25|81.77|
71882448|NCT00440947|143283931|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA \<50 c/mL at Week 84 was -12% or greater.|Risk Difference (RD)|5.4||||0.14|TWO_SIDED|95.0|-1.8|12.5|||Cochran-Mantel-Haenszel|p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (\<100000/\>=100000)||||12.5|-1.8|0.140
71882449|NCT02017327|143284003|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71882450|NCT02017327|143284003|SUPERIORITY|||||||0.0045|||||||Cochran-Mantel-Haenszel|||||||0.0045
71882451|NCT01265797|143284015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare outcome measures between two treatment groups in the run-in month minus blinded month||The a priori alpha level was set at p \< 0.05, and a power of 0.80 (80%) was used to compute the number of subjects needed to find a meaningful difference between the verum and sham groups. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group.||||0.30
71882452|NCT01265797|143284016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.89|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare secondary outcome measures between two treatment groups in the run-in month minus open label month||||||0.89
71882453|NCT01265797|143284017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.30
71882454|NCT01265797|143284018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare the primary and secondary outcome measures between the two treatment groups.||The a priori alpha level was set at p \< 0.05, and beta 0.2. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group. The null hypothesis: No difference in the depression score/14 day recall between the two groups.||||0.98
71882455|NCT01265797|143284019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.75
71882456|NCT01265797|143284020|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
71860438|NCT00267098|143235495|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.844|||||TWO_SIDED|95.0|-12.91|-4.681||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing."||-4.681|-12.910|
71860439|NCT00267098|143235496|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-6.615|||||TWO_SIDED|95.0|-11.37|-1.736||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDVI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.||-1.736|-11.370|
71860440|NCT00267098|143235497|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-3.894|||||TWO_SIDED|95.0|-12.13|3.953||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||3.953|-12.130|
71860441|NCT00267098|143235498|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-10.16|||||TWO_SIDED|95.0|-19.33|-0.857||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||-0.857|-19.330|
71860442|NCT00267098|143235499|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-8.316|||||TWO_SIDED|95.0|-18.19|1.623||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||1.623|-18.190|
71882457|NCT01265797|143284021|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.02|TWO_SIDED|||||Change in mean anxiety score/ 14 day recall from the blinded period to open label period|Wilcoxon (Mann-Whitney)|||||||0.02
71882458|NCT01265797|143284022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.98|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.98
71882459|NCT01265797|143284023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.97|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.97
71882460|NCT01265797|143284024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.87
71882461|NCT01265797|143284025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.83
71882462|NCT01265797|143284026|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.92|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.92
71882463|NCT02813694|143284027|NON_INFERIORITY|non-inferiority margin= 10%|Treatment difference|0.1|||||TWO_SIDED|95.0|-4.4|4.5|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic|||4.5|-4.4|
71882464|NCT02813694|143284028|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.3|3.1|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.1|-6.3|
71860443|NCT00267098|143235500|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-11.08|||||TWO_SIDED|95.0|-21.11|-0.956||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LV Mass through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||-0.956|-21.110|
71860444|NCT00267098|143235501|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.126|||||TWO_SIDED|95.0|-0.235|-0.014||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.014|-0.235|
71860445|NCT00267098|143235502|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.162|||||TWO_SIDED|95.0|-0.287|-0.035||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.035|-0.287|
71860446|NCT00267098|143235503|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.163|||||TWO_SIDED|95.0|-0.293|-0.03||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.030|-0.293|
71907068|NCT03784027|143336342|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values. Differences in percents are shown in percentage points.|Mean Difference (Final Values)|-0.7|||||TWO_SIDED|95.0|-1.5|0.05|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.05|-1.5|
71907069|NCT03784027|143336343|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.1|0.1||The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.1|-0.1|
71907070|NCT03784027|143336344|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-1.6|-0.6|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||-0.6|-1.6|
71907071|NCT03784027|143336345|NON_INFERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.006|0.009|||||Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.009|-0.006|
71907072|NCT03784027|143336346|SUPERIORITY||Mean Difference (Final Values)|0.004||||0.75|TWO_SIDED|95.0|-0.02|0.03|||Regression, Linear|Based on a longitudinal model adjusting for baseline value and period as fixed effects. The model accounts for correlated data from the same subject.||||0.03|-0.02|0.75
71907073|NCT03784027|143336347|SUPERIORITY|The mean adjusted differences are based on a linear mixed model with adjustment for repeated participant measures, with period as a fixed effect and trial site as a random effect; the model also accounted for the baseline values.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.1|0.8|||||(For total daily insulin use) Confidence intervals for the secondary end points were adjusted for multiple comparisons with the use of the Benjamini-Hochberg procedure to control the false discovery rate.|||0.8|-0.1|
71681417|NCT03280225|142881294|OTHER||Odds Ratio (OR)|1.43||||0.302|TWO_SIDED|95.0|0.73|2.82|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a coordinator during the 6 month period following implementation compared to eligible Veterans being assigned a coordinator in the 6 month period prior to implementation.||2.82|0.73|.302
71860447|NCT00267098|143235504|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.245|||||TWO_SIDED|95.0|-0.39|-0.097||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVEDD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.||-0.097|-0.390|
71860448|NCT00267098|143235505|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.066|||||TWO_SIDED|95.0|-0.185|0.055||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.055|-0.185|
71860449|NCT00267098|143235506|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.104|||||TWO_SIDED|95.0|-0.236|0.029||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.029|-0.236|
71860450|NCT00267098|143235507|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.06|||||TWO_SIDED|95.0|-0.204|0.087||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.||0.087|-0.204|
71860451|NCT00267098|143235508|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.18|||||TWO_SIDED|95.0|-0.339|-0.018||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in LVESD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.||-0.018|-0.339|
71882465|NCT02813694|143284028|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-1.6|||||TWO_SIDED|95.0|-6.5|3.3|||||Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.|||3.3|-6.5|
71882466|NCT02813694|143284029|NON_INFERIORITY|non-inferiority margain = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.2|0.5|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\]; PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||0.5|-8.2|
71882467|NCT02813694|143284029|NON_INFERIORITY|non-inferiority margin = 10%|Treatment difference|-3.9|||||TWO_SIDED|95.0|-8.4|0.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.|||0.7|-8.4|
71907074|NCT00915538|143336419|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The expected results for non-inferiority would be +/- 5% of difference between the two groups in the primary efficacy parameter.|AUC|0.0||||0.76|TWO_SIDED||||||t-test, 2 sided|||The cross-over means there were 16 determinants for each time for each treatment. The AUC of FEV-1 was measured in each subject for each treatment arm and the mean of this data was compared.||||0.76
71907075|NCT00915538|143336419|OTHER|Two sample T test|Mean Difference (Net)|0.0|STANDARD_DEVIATION|12.0|>|0.05|TWO_SIDED||||||t-test, 2 sided|||||||>.05
71907076|NCT00915538|143336420|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation was not done for secondary parameter. The comparison was for the FEV-1/FVC expressed as fraction at each time point||||||0.76|TWO_SIDED|95.0|||||t-test, 2 sided|||The cross over means there were 16 determinants for each time for each treatment||||0.76
71907077|NCT02307838|143336421|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.59||||0.0155|TWO_SIDED|95.0|-1.07|-0.11|||ANCOVA|||||-0.11|-1.07|0.0155
71907078|NCT03372603|143336449|OTHER||Ratio|1.336|||||TWO_SIDED|90.0|0.965|1.847|||||Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.|||1.847|0.965|
71907079|NCT02806947|143336468|OTHER|No formal hypothesis test was planned or performed for comparing Day 28 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 90% confidence interval.|Risk Difference (RD)|-0.082|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|90.0|-0.223|0.059|||||The risk difference estimate is the observed proportion of Day 28 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|The primary objective of this Phase II trial was to describe the proportion of patients with Day 28 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 90% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.059|-0.223|
71907080|NCT02806947|143336468|OTHER|No formal hypothesis test was planned or performed for comparing Day 56 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 95% confidence interval.|Risk Difference (RD)|-0.152|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|95.0|-0.315|0.011|||||The risk difference estimate is the observed proportion of Day 56 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|A secondary objective of this Phase II trial was to describe the proportion of patients with Day 56 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 95% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.||0.011|-0.315|
71907081|NCT02806947|143336469|SUPERIORITY||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with CR/PR and steroid dose of 0.25mg/kg/day or less at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||< 0.001
71907082|NCT02806947|143336470|SUPERIORITY|||||||0.32||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 28 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.320
71907083|NCT02806947|143336470|SUPERIORITY|||||||0.014||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 56 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.||||0.014
71907084|NCT02806947|143336471|SUPERIORITY|||||||0.078||||||Statistical significance was determine using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.078
71907085|NCT02806947|143336471|SUPERIORITY|||||||0.068||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 56 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.068
71907086|NCT02806947|143336472|SUPERIORITY|||||||0.785||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with overall survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.785
71907087|NCT02806947|143336473|SUPERIORITY|||||||0.34||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with disease-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.340
71907088|NCT02806947|143336474|SUPERIORITY|||||||0.713||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with event-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.||||0.713
71907089|NCT02806947|143336475|SUPERIORITY|||||||0.726||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with non-relapse mortality between the sirolimus and prednisone arms during the 12 month period post-randomization, with malignancy relapse treated as a competing risk for non-relapse mortality. These proportions were compared between treatment arms using Gray's test.||||0.726
71922042|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|7.8|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.0|15.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||15.5|0|
71922043|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|8.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|0.6|16.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, post-dose AM 4 hour||16.1|0.6|
71860452|NCT00267098|143235509|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.683|||||TWO_SIDED|95.0|-2.828|1.506||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||1.506|-2.828|
71860453|NCT00267098|143235510|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.564|||||TWO_SIDED|95.0|-2.843|1.773||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||1.773|-2.843|
71860454|NCT00267098|143235511|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.016|||||TWO_SIDED|95.0|-2.379|2.425||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||2.425|-2.379|
71860455|NCT00267098|143235512|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.653|||||TWO_SIDED|95.0|-3.337|2.046||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in MR through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||2.046|-3.337|
71860456|NCT00267098|143235513|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.08|||||TWO_SIDED|95.0|-0.031|0.195||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.195|-0.031|
71882468|NCT01087905|143284054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.076|TWO_SIDED|95.0|0.98|1.61|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT)."||1.61|0.98|.076
71882469|NCT01087905|143284054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT)."||1.75|1.06|.017
71882470|NCT01087905|143284054|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.343|TWO_SIDED|95.0|0.69|1.14|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC)."||1.14|0.69|.343
71860457|NCT00267098|143235514|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.086|||||TWO_SIDED|95.0|-0.022|0.198||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.198|-0.022|
71860458|NCT00267098|143235515|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.081|||||TWO_SIDED|95.0|-0.218|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.058|-0.218|
71860459|NCT00267098|143235516|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.047|||||TWO_SIDED|95.0|-0.095|0.192||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in CI through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.192|-0.095|
71860460|NCT00267098|143235517|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|29.3|||||TWO_SIDED|95.0|10.04|48.64||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.||48.640|10.040|
71860461|NCT00267098|143235518|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|21.83|||||TWO_SIDED|95.0|2.841|40.87||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.||40.870|2.841|
71860462|NCT00267098|143235519|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|26.53|||||TWO_SIDED|95.0|6.247|47.19||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.||47.190|6.247|
71882471|NCT01087905|143284055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.029|TWO_SIDED|95.0|1.04|2.14|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.14|1.04|.029
71681418|NCT03280225|142881295|OTHER||Odds Ratio (OR)|1.29||||0.226|TWO_SIDED|95.0|0.86|1.93|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans being assigned a provider during the 6 month period following implementation compared to eligible Veterans being assigned a provider in the 6 month period prior to implementation.||1.93|0.86|0.226
71681419|NCT03280225|142881296|OTHER||Odds Ratio (OR)|1.23||||0.199|TWO_SIDED|95.0|0.9|1.7|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans receiving a care evaluation during the 6 month period following implementation compared to eligible Veterans receiving a care evaluation in the 6 month period prior to implementation.||1.70|0.90|0.199
71681420|NCT03280225|142881297|OTHER||Odds Ratio (OR)|1.38||||0.011|TWO_SIDED|95.0|1.08|1.76|||Regression, Logistic||Odds ratios were estimated using GEE to control for clustering within VAMCs. Fixed effects included a time-dependent variable (pre-post) as well an independent variable of time to account for improvement due to secular trends.|Odds Ratio of eligible Veterans where outreach was attempted during the 6 month period following implementation compared to eligible Veterans where outreach was attempted in the 6 month period prior to implementation.||1.76|1.08|0.011
71681421|NCT03280225|142881298|SUPERIORITY|||||||0.018|||||||ANOVA|F (4, 158) = 3.08||Program Needs||||.018
71860463|NCT00267098|143235520|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|23.32|||||TWO_SIDED|95.0|1.999|44.53||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in IVMD through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.||44.530|1.999|
71860464|NCT00267098|143235521|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.047|||||TWO_SIDED|95.0|-0.18|0.089||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 6 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.||0.089|-0.180|
71860465|NCT00267098|143235522|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|-0.117|||||TWO_SIDED|95.0|-0.287|0.058||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 12 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.||0.058|-0.287|
71907090|NCT02806947|143336476|SUPERIORITY|||||||0.402||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with malignancy relapse between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for malignancy relapse. These proportions were compared between treatment arms using Gray's test.||||0.402
71907091|NCT02806947|143336477|SUPERIORITY|||||||0.296||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the sirolimus and prednisone arms during the 12 month period post-randomization, with death and malignancy relapse treated as competing risks for chronic GVHD. These proportions were compared between treatment arms using Gray's test.||||0.296
71907092|NCT02806947|143336478|SUPERIORITY|||||||0.936||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.936
71681422|NCT03280225|142881298|SUPERIORITY|||||||0.136|||||||ANOVA|F (4, 158) = 1.78||Training Needs||||.136
71681423|NCT03280225|142881298|SUPERIORITY|Pressure for Change||||||0.812|||||||ANOVA|F (4, 158) = 0.39||||||.812
71681424|NCT03280225|142881298|SUPERIORITY|Staffing||||||0.358|||||||ANOVA|F (4, 158) = 1.10||||||.358
71681425|NCT03280225|142881298|SUPERIORITY|Mission||||||0.748|||||||ANOVA|F (4, 158) = 0.48||||||.748
71681426|NCT03280225|142881298|SUPERIORITY|||||||0.748|||||||ANOVA|F (4, 158) = 0.48||Cohesion||||.748
71681427|NCT03280225|142881298|SUPERIORITY|||||||0.005|||||||ANOVA|F (4, 158) = 3.88||Autonomy||||.005
71681428|NCT03280225|142881298|SUPERIORITY|||||||0.224|||||||ANOVA|F (4, 158) = 1.44||Communication||||.224
71681429|NCT03280225|142881298|SUPERIORITY|||||||0.043|||||||ANOVA|F (4, 158) = 2.52||Stress||||.043
71860466|NCT00267098|143235523|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.041|||||TWO_SIDED|95.0|-0.136|0.22||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 18 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.||0.220|-0.136|
71860467|NCT00267098|143235524|SUPERIORITY_OR_OTHER||Posterior BiV - RV Mean Difference|0.11|||||TWO_SIDED|95.0|-0.085|0.311||BLOCK HF is a Bayesian study; a p-value was not used since it is a non-Bayesian statistical tool. Instead,a posterior distribution representing the set of possible values for the BiV - RV difference in change in E/A through 24 months was used.|Bayesian Credible Interval||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.||0.311|-0.085|
71860468|NCT00267098|143235525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1841||||0.9985||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9985
71860469|NCT00267098|143235526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2503||||0.9999||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9999
71860470|NCT00267098|143235527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1978||||0.9978||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9978
71907093|NCT02806947|143336478|SUPERIORITY|||||||0.598||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.||||0.598
71907094|NCT02806947|143336479|SUPERIORITY|||||||0.221||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with serious infections between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for serious infection. These proportions were compared between treatment arms using Gray's test.||||0.221
71907095|NCT00865189|143336488|SUPERIORITY_OR_OTHER|||||||0.015|||||||Binomial test|||This proportion was described for each treatment arm with a 95% confidence interval (CI) and compared with the standard proportion of 10% (CI) for each treatment arm.||||0.015
71907096|NCT00865189|143336488|SUPERIORITY_OR_OTHER|||||||0.906|||||||Binomial test|||This proportion was described for each treatment arm with a 95% CI and compared with the standard proportion of 10% (CI) using for each treatment arm.||||0.906
71907097|NCT01978509|143336499|SUPERIORITY|||||||0.7|||||||ANOVA|||||||0.70
71681430|NCT03280225|142881298|SUPERIORITY|||||||0.096|||||||ANOVA|F (4, 158) = 2.01||Change||||.096
71681431|NCT01260272|142881336|SUPERIORITY_OR_OTHER||||||=|0.033||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.033
71681432|NCT01260272|142881337|SUPERIORITY_OR_OTHER||||||=|0.0468||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.0468
71681433|NCT01260272|142881338|SUPERIORITY_OR_OTHER||||||=|0.2114||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2114
71681434|NCT01260272|142881339|SUPERIORITY_OR_OTHER||||||=|0.1727||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.1727
71681435|NCT01260272|142881340|SUPERIORITY_OR_OTHER||||||=|0.7498||||||Apriori threshold for statistical significance was \<=0.05|Wilcoxon (Mann-Whitney)|||||||=0.7498
71860471|NCT00267098|143235528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2069||||0.9983||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.||||0.9983
71860472|NCT00267098|143235530|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.189|TWO_SIDED|95.0|0.78|2.01||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.||2.01|0.78|0.189
71860473|NCT01527162|143235574|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71860474|NCT01527162|143235575|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.14|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.14
71860475|NCT01527162|143235576|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon Sign Rank TEst||||>.54
71860476|NCT01527162|143235576|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||= 0.20
71907098|NCT03641547|143336503|OTHER||Post prob of tox at dose level 6|0.029|||||TWO_SIDED|95.0|0.0|0.165||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE-CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.165|0|
71681436|NCT01260272|142881341|SUPERIORITY_OR_OTHER||||||=|0.2615||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.2615
71860477|NCT04599907|143235578|SUPERIORITY||||||<|0.05|||||||Cochran-Mantel-Haenszel|||||||<0.05
71860478|NCT04599907|143235579|SUPERIORITY||Mean Difference (Final Values)|-0.91|||<|0.05|TWO_SIDED|95.0|-1.42|-0.04|||Mixed Models Analysis|||"This is the data for the Level of Botherstatistical analysis"||-0.040|-1.42|<0.05
71860479|NCT04599907|143235579|SUPERIORITY||Mean Difference (Final Values)|-0.87|||<|0.05|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||"This is the data for the Level of Impact on Daily Activities Statistical Analysis"||-0.40|-1.35|<0.05
71681437|NCT01260272|142881342|SUPERIORITY_OR_OTHER||||||=|0.6915||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||=0.6915
71681438|NCT01260272|142881343|SUPERIORITY_OR_OTHER|||||||0.106||||||Apriori threshold for statistical significance was \<=0.05|t-test, 2 sided|||||||0.1060
71681439|NCT00435487|142881344|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-2.6||||||95.0|-8.59|3.4|||upper limit of 95% CI <= 10%||95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||3.40|-8.59|
71681440|NCT00435487|142881344|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|1.25||||||95.0|-3.02|5.52|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.52|-3.02|
71860480|NCT05093504|143235622|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71860481|NCT03733899|143235668|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|4.96|||TWO_SIDED|95.0|-7.3|12.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||12.4|-7.3|
71907099|NCT03641547|143336504|OTHER||Post prob of tox at dose level 4|0.185|||||TWO_SIDED|95.0|0.042|0.397||||||The primary analysis is performed using the Time-To-Event Continual Reassessment Method (TiTE CRM). Giving posterior estimates for the probability of toxicity (DLT) at each dose level.||0.397|0.042|
71860482|NCT03733899|143235668|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|5.3|||TWO_SIDED|95.0|-9.6|11.5|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||11.5|-9.6|
71860483|NCT03733899|143235668|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-8.2|9.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||9.8|-8.2|
71860484|NCT03733899|143235668|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|4.67|||TWO_SIDED|95.0|-6.5|12.2|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||12.2|-6.5|
71860485|NCT03733899|143235668|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|4.37|||TWO_SIDED|95.0|-5.7|11.7|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||11.7|-5.7|
71860486|NCT03733899|143235668|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-1.4|16.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||16.8|-1.4|
71860487|NCT03733899|143235669|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|95.0|-10.3|14.4|||Linear Mixed Model||Difference was calculated as Test - Placebo|5-Mintues Post Treatment||14.4|-10.3|
71860488|NCT03733899|143235669|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.0|-12.1|12.9|||Linear Mixed Model||Difference was calculated as Test - Placebo|10-Minutes Post Treatment||12.9|-12.1|
71860489|NCT03733899|143235669|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|5.92|||TWO_SIDED|95.0|-11.4|12.1|||Linear Mixed Model||difference was calculated as Test - Placebo.|5-Minutes Post Treatment||12.1|-11.4|
71860490|NCT03733899|143235669|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.4|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-9.2|14.0|||Linear Mixed Model||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment||14.0|-9.2|
71860491|NCT03733899|143235669|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|STANDARD_ERROR_OF_MEAN|5.76|||TWO_SIDED|95.0|-8.5|14.3|||Linear Mixed Model||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment||14.3|-8.5|
71860492|NCT03733899|143235669|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.6|STANDARD_ERROR_OF_MEAN|5.67|||TWO_SIDED|95.0|-3.7|18.8|||Linear Mixed Model||difference was calculated as Test - Placebo.|10-Mintues Post Treatment||18.8|-3.7|
71860493|NCT03733899|143235670|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.0|STANDARD_ERROR_OF_MEAN|4.61|||TWO_SIDED|95.0|-13.2|5.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|5.1|-13.2|
71860494|NCT03733899|143235670|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|4.85|||TWO_SIDED|95.0|-13.9|5.3|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|5.3|-13.9|
71860495|NCT03733899|143235670|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|4.04|||TWO_SIDED|95.0|-24.4|-8.3|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-8.3|-24.4|
71860496|NCT03733899|143235670|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|4.14|||TWO_SIDED|95.0|-17.8|-1.4|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|-1.4|-17.8|
71860497|NCT03733899|143235670|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-12.3|STANDARD_ERROR_OF_MEAN|4.15|||TWO_SIDED|95.0|-20.6|-4.1|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).|-4.1|-20.6|
71860498|NCT03733899|143235670|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-8.2|STANDARD_ERROR_OF_MEAN|4.25|||TWO_SIDED|95.0|-16.7|0.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).|0.2|-16.7|
71907100|NCT00418379|143336515|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
71907101|NCT00418379|143336515|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||< 0.0001
71907102|NCT01594333|143336519|SUPERIORITY||Cox Proportional Hazard|1.01||||0.91|TWO_SIDED|95.0|0.82|1.25||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(diabetes or metabolic syndrome alone)|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.25|0.82|0.91
71907103|NCT01594333|143336520|SUPERIORITY||Cox Proportional Hazard|0.96||||0.67|TWO_SIDED|95.0|0.79|1.16||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status(metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.16|0.79|0.67
71907104|NCT01594333|143336521|SUPERIORITY||Cox Proportional Hazard|1.16||||0.32|TWO_SIDED|95.0|0.87|1.56||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes at enrollment).|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.56|0.87|0.32
71907105|NCT01594333|143336522|SUPERIORITY||Cox Proportional Hazard|0.95||||0.57|TWO_SIDED|95.0|0.81|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (metabolic syndrome alone or diabetes) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.81|0.57
71907106|NCT01594333|143336523|SUPERIORITY||Cox Proportional Hazard|0.89||||0.54|TWO_SIDED|95.0|0.6|1.31||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, type of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.31|0.60|0.54
71907107|NCT01594333|143336524|SUPERIORITY||Cox Proportional Hazard|0.98||||0.8|TWO_SIDED|95.0|0.84|1.14||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time since qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.14|0.84|0.80
71907108|NCT01594333|143336526|SUPERIORITY||Cox Proportional Hazard|0.81||||0.31|TWO_SIDED|95.0|0.53|1.22||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment.|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.22|0.53|0.31
71907109|NCT01594333|143336527|SUPERIORITY||Cox Proportional Hazard|0.92||||0.38|TWO_SIDED|95.0|0.75|1.12||2-sided unadjusted p-value|Log Rank|Stratified according to type of qualifying event, time of qualifying event and risk status (diabetes or metabolic syndrome alone) at enrollment|Confidence intervals have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.|||1.12|0.75|0.38
71907110|NCT02666508|143336534|OTHER|Test conducted was a test of difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in DPIA from pre to post.|Mean Difference (Net)|-1.02||||0.001|TWO_SIDED|95.0|-1.6|-0.44|||Repeated Measures ANOVA|||||-0.44|-1.60|0.001
71907111|NCT02666508|143336535|OTHER|Test conducted was a test of the difference between plaque identifying toothpaste and non-plaque identifying toothpaste for change in hsCRP|Mean Difference (Net)|-0.18||||0.459|TWO_SIDED|95.0|-0.69|0.32|||Repeated Measures ANOVA|||||0.32|-0.69|0.459
71907112|NCT03428997|143336563|EQUIVALENCE|Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect|Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.274|||||||2-sided t-test|||Testing hypothesis is that the mean score is equal between the compared treatments.||||0.274
71907113|NCT00400712|143336584|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANCOVA|Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05||||||0.44
71907114|NCT00400712|143336585|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.83
71907115|NCT00400712|143336586|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||ANCOVA|||ANCOVA - comparing absolute measures and including baseline as co-variate||||0.45
71907116|NCT00400712|143336587|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||ANCOVA|adjusted for baseline values||||||0.72
71907117|NCT00400712|143336588|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANCOVA|controlled for baseline values||||||0.60
71907118|NCT00400712|143336589|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.66
71907119|NCT00400712|143336590|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA|||||||0.78
71907120|NCT01632735|143336614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.57|0.99|||GEE|Generalized Estimating Equations regression examined primary relapse (measured by urinalysis) over time by condition, controlling for age and gender.||||0.99|0.57|<0.05
71860499|NCT03733899|143235671|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.07|||TWO_SIDED|95.0|-8.7|11.6|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|11.6|-8.7|
71860500|NCT03733899|143235671|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-1.0|18.0|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin|18.0|-1.0|
71907121|NCT01632735|143336615|SUPERIORITY_OR_OTHER||Beta (timexcondition)|0.239|||<|0.001|TWO_SIDED|95.0|0.219|0.248|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the primary outcome measures of recovery behaviors mean days over time (baseline, discharge, 3, 6, and 9-month follow-ups).||0.248|0.219|<0.001
71907122|NCT01632735|143336616|SUPERIORITY_OR_OTHER||Beta (time x condition)|0.115|||<|0.001|TWO_SIDED|95.0|0.106|0.123|||Mixed Models Analysis|A repeated-measures model tested for effects of treatment vs. control on recovery self-confidence over time controlling for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of recovery confidence mean score over time.||0.123|0.106|<0.001
71907123|NCT01632735|143336617|SUPERIORITY_OR_OTHER||Beta effect (timexcondition)|0.217|||<|0.001|TWO_SIDED|95.0|0.2|0.233|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of self-help utilization (mean days in past month) over the study period (baseline, discharge, and 3-, 6-, and 9-month follow-ups).||0.233|0.2|<0.001
71907124|NCT00115765|143336628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.011||95.0|1.06|1.52|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.52|1.06|0.011
71907125|NCT00115765|143336629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.005||95.0|1.11|1.83|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose \< 85 mg/m2, and oxaliplatin dose \> 100 mg/m2||||1.83|1.11|0.005
71907126|NCT00115765|143336633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.738||95.0|0.6|2.05|||Regression, Logistic|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.05|0.60|0.738
71907127|NCT00115765|143336634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.257||95.0|0.77|2.62|||Regression, Cox|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site||||2.62|0.77|0.257
71907128|NCT00115765|143336636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.36||||||95.0|1.04|1.77||||||||1.77|1.04|
71907129|NCT00115765|143336637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||||95.0|0.91|1.71||||||||1.71|0.91|
71907130|NCT00115765|143336638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.89||||||95.0|1.3|2.75||||||||2.75|1.30|
71907131|NCT00115765|143336639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||||95.0|0.67|1.54||||||||1.54|0.67|
71907132|NCT00115765|143336640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||||95.0|0.61|2.66||||||||2.66|0.61|
71907133|NCT00115765|143336641|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||||95.0|0.28|1.67||||||||1.67|0.28|
71907134|NCT04111107|143336732|OTHER|||||||0.966|||||||Wilcoxon signed rank (2 sided)|||H0: Progression-free ratio = 1||||0.966
71907135|NCT04111107|143336735|OTHER|Single proportion was estimated.|proportion|4.2|||||TWO_SIDED|95.0|0.1|21.1|||||exact binomial confidence interval|The proportion with a complete or partial response was estimated and an exact binomial confidence interval was calculated||21.1|0.1|
71907136|NCT03011450|143336755|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907137|NCT03011450|143336756|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907138|NCT03011450|143336757|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907139|NCT03011450|143336758|SUPERIORITY|||||||0.0156|||||||Hodges-Lehmann method|||||||0.0156
71907140|NCT03011450|143336759|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907141|NCT03011450|143336760|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907142|NCT03011450|143336761|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907143|NCT03011450|143336762|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
71907144|NCT03011450|143336763|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907145|NCT03011450|143336764|SUPERIORITY|||||||0.538|||||||Hodges-Lehmann method|||||||0.5380
71907146|NCT03011450|143336765|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907147|NCT03011450|143336766|SUPERIORITY|||||||0.1165|||||||Hodges-Lehmann method|||||||0.1165
71907148|NCT03011450|143336767|SUPERIORITY|||||||0.0142|||||||Hodges-Lehmann method|||||||0.0142
71907149|NCT03011450|143336768|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907150|NCT03011450|143336769|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907151|NCT03011450|143336770|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907152|NCT03011450|143336771|SUPERIORITY|||||||0.4589|||||||Hodges-Lehmann method|||||||0.4589
71907153|NCT03011450|143336772|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907154|NCT03011450|143336773|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907155|NCT03011450|143336774|OTHER||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907156|NCT03011450|143336775|SUPERIORITY|||||||0.2486|||||||Hodges-Lehmann method|||||||0.2486
71907157|NCT03011450|143336776|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907158|NCT03011450|143336777|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71860501|NCT03733899|143235671|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-3.5|17.0|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|17.0|-3.5|
71860502|NCT03733899|143235671|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|4.82|||TWO_SIDED|95.0|1.6|20.8|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin|20.8|1.6|
71860503|NCT03733899|143235672|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|6.12|||TWO_SIDED|95.0|-11.4|12.9|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 10-mintues post treatment - Pre Treatment.|12.9|-11.4|
71860504|NCT03733899|143235672|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|7.8|STANDARD_ERROR_OF_MEAN|6.1|||TWO_SIDED|95.0|-4.9|19.9|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 5-mintues post treatment - Pre Treatment.|19.9|-4.9|
71860505|NCT03733899|143235672|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.19|||TWO_SIDED|95.0|-9.3|15.2|||Mixed Models Analysis|||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 10-mintues post treatment - Pre Treatment.|15.2|-9.3|
71860506|NCT03733899|143235672|SUPERIORITY|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|6.17|||TWO_SIDED|95.0|-4.9|19.6|||Mixed Models Analysis|||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 5-mintues post treatment - Pre Treatment.|19.6|-4.9|
71860507|NCT03733899|143235673|SUPERIORITY|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|-12.4|STANDARD_ERROR_OF_MEAN|4.22|||TWO_SIDED|95.0|-20.9|-3.9|||Mixed Models Analysis||||mean difference was calculated as postremoval minus pre-insertion with Test and corneal region.|-3.9|-20.9|
71860508|NCT00379769|143235765|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication|Hazard Ratio (HR)|0.99||||||95.0|0.85|1.16||||||||1.16|0.85|
71860509|NCT00379769|143235789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||||95.0|0.68|1.08||||||||1.08|0.68|
71860510|NCT00379769|143235790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||||95.0|0.78|1.17||||||||1.17|0.78|
71860511|NCT00379769|143235791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||||95.0|0.79|1.18||||||||1.18|0.79|
71907159|NCT03011450|143336778|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907160|NCT03011450|143336779|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907161|NCT03011450|143336780|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
71860512|NCT00379769|143235792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
71860513|NCT00379769|143235793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21||||||||1.21|0.68|
71860514|NCT00379769|143235794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||||95.0|0.8|1.59||||||||1.59|0.80|
71860515|NCT00379769|143235795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||||95.0|0.82|1.62||||||||1.62|0.82|
71860516|NCT00379769|143235796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||||95.0|0.54|1.14||||||||1.14|0.54|
71860517|NCT00379769|143235797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||||95.0|0.57|1.18||||||||1.18|0.57|
71860518|NCT01641653|143235825|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.||||0.87
71860519|NCT01641653|143235826|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|10.0||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||percent change in glucose levels from preoperative level to maximum perioperative measurement level||||0.56
71860520|NCT01641653|143235827|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED|||||Chi-square with continuity correction|Chi-squared, Corrected|||||||0.12
71860521|NCT02666664|143235841|SUPERIORITY||Difference in LS mean|-18.1|STANDARD_ERROR_OF_MEAN|1.01|<|0.001|TWO_SIDED|95.0|-20.0|-16.1|||ANCOVA|||||-16.1|-20|<0.001
71860522|NCT02666664|143235843|SUPERIORITY||Difference in LS mean|-16.1|STANDARD_ERROR_OF_MEAN|1.07|<|0.001|TWO_SIDED|95.0|-18.2|-14.0|||ANCOVA|||||-14|-18.2|<0.001
71860523|NCT02666664|143235844|SUPERIORITY||Difference in LS mean|-13.3|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-15.1|-11.6|||ANCOVA|||||-11.6|-15.1|<0.001
71860524|NCT02666664|143235845|SUPERIORITY||Difference in LS mean|-11.1|STANDARD_ERROR_OF_MEAN|0.69|<|0.001|TWO_SIDED|95.0|-12.5|-9.8|||ANCOVA|||||-9.8|-12.5|<0.001
71860525|NCT02666664|143235846|SUPERIORITY||Difference in LS mean|-11.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|-13.6|-10.2|||ANCOVA|||||-10.2|-13.6|<0.001
71860526|NCT02666664|143235847|SUPERIORITY||Location shift|-21.5|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-26.96|-16.0|||Wilcoxon (Mann-Whitney)|||||-16|-26.96|<0.001
71860527|NCT02666664|143235848|SUPERIORITY||Difference in LS mean|-13.6|STANDARD_ERROR_OF_MEAN|1.13|<|0.001|TWO_SIDED|95.0|-15.8|-11.3|||ANCOVA|||||-11.3|-15.8|<0.001
71860528|NCT02666664|143235857|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71907162|NCT03011450|143336781|SUPERIORITY|||||||0.2763|||||||Hodges-Lehmann method|||||||0.2763
71907163|NCT03011450|143336782|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907164|NCT03011450|143336783|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907165|NCT03011450|143336784|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907166|NCT03011450|143336785|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907167|NCT03011450|143336786|SUPERIORITY|||||||0.1651|||||||Hodges-Lehmann method|||||||0.1651
71907168|NCT03011450|143336787|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907169|NCT03011450|143336788|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907170|NCT03011450|143336789|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71688699|NCT02634983|142892847|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment\*Day\*time interaction term as fixed factors and patient factor as random factor. Day\*time was repeated within each patient\*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.98|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|90.0|3.56|6.39|||t-test, 2 sided|||FEV1/FVC Day 8 (2 hrs post-dose)||6.39|3.56|<0.0001
71860529|NCT01385748|143235871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.165|TWO_SIDED|95.0|0.387|1.186|||Log Rank|The log rank test at 5% significance level was used.||||1.186|0.387|0.165
71860530|NCT01385748|143235871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.421|TWO_SIDED|95.0|0.495|1.35|||Log Rank|The log rank test at 5% significance level was used.||||1.35|0.495|0.421
71860531|NCT01385748|143235871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.754||||0.211|TWO_SIDED|95.0|0.484|1.175|||Log Rank|The log rank test at 5% significance level was used.||||1.175|0.484|0.211
71860532|NCT01385748|143235874|SUPERIORITY_OR_OTHER|||||||0.807||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.807
71860533|NCT01385748|143235874|SUPERIORITY_OR_OTHER|||||||0.971||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)|||||||0.971
71860534|NCT01385748|143235876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.698||||0.199|TWO_SIDED|95.0|0.398|1.223||Significance threshold = 5%|Log Rank|||||1.223|0.398|0.199
71860535|NCT01385748|143235876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.817||||0.424|TWO_SIDED|95.0|0.493|1.353|||Log Rank|Significance threshold = 5%||||1.353|0.493|0.424
71860536|NCT01385748|143235876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.235|TWO_SIDED|95.0|0.489|1.193|||Log Rank|Significance threshold = 5%||||1.193|0.489|0.235
71860537|NCT01385748|143235877|SUPERIORITY_OR_OTHER|||||||0.176|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.176
71860538|NCT01385748|143235877|SUPERIORITY_OR_OTHER|||||||0.61|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.61
71860539|NCT01385748|143235877|SUPERIORITY_OR_OTHER|||||||0.295|||||||Kruskal-Wallis|Significance threshold = 5%||||||0.295
71860540|NCT01385748|143235878|SUPERIORITY_OR_OTHER|||||||0.063||||||Significance threshold = 5%|Chi-squared|||||||0.063
71860541|NCT01385748|143235878|SUPERIORITY_OR_OTHER|||||||0.169|||||||Chi-squared|||||||0.169
71860542|NCT01385748|143235878|SUPERIORITY_OR_OTHER|||||||0.064|||||||Chi-squared|Significance threshold = 5%||||||0.064
71907171|NCT03011450|143336790|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71860543|NCT01385748|143235879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.824||||0.388|TWO_SIDED|95.0|0.484|1.401|||Log Rank|Significance threshold = 5%||||1.401|0.484|0.388
71860544|NCT01385748|143235879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.601||||0.054|TWO_SIDED|95.0|0.357|1.012|||Log Rank|Significance threshold = 5%||||1.012|0.357|0.054
71860545|NCT01385748|143235879|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.102|TWO_SIDED|95.0|0.444|1.078|||Log Rank|Significance threshold = 5%||||1.078|0.444|0.102
71860546|NCT01458522|143235884|OTHER|||||||0.512|||||||Poisson regression model|||||||0.512
71860547|NCT03121820|143235927|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|93.8||||0.05|TWO_SIDED|90.0|88.25|99.77|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||99.77|88.25|0.05
71860548|NCT03121820|143235928|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|92.3||||0.05|TWO_SIDED|90.0|86.37|98.55|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg||98.55|86.37|0.05
71860549|NCT00730015|143235929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.72|||<|0.0001|TWO_SIDED|95.0|3.41|17.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be at least 90% based on study NCT00402337(MCP-103-201) data.||17.47|3.41|<0.0001
71860550|NCT00730015|143235929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.21|||<|0.0001|TWO_SIDED|95.0|3.14|16.59||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be greater than 96% based on study NCT00402337(MCP-103-201) data.||16.59|3.14|<0.0001
71882472|NCT01087905|143284055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.079|TWO_SIDED|95.0|0.96|1.97|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||1.97|0.96|.079
71907172|NCT03011450|143336791|SUPERIORITY|||||||0.5107|||||||Hodges-Lehmann method|||||||0.5107
71907173|NCT03011450|143336792|SUPERIORITY||Hodges-Lehmann method|||||0.0018|||||||Hodges-Lehmann method|||||||0.0018
71907174|NCT03011450|143336793|SUPERIORITY|||||||0.0742|||||||Hodges-Lehmann method|||||||0.0742
71907175|NCT03011450|143336794|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907176|NCT03011450|143336795|SUPERIORITY|||||||0.2707|||||||Hodges-Lehmann method|||||||0.2707
71907177|NCT03011450|143336796|SUPERIORITY|||||||0.0009|||||||Hodges-Lehmann method|||||||0.0009
71907178|NCT03011450|143336797|SUPERIORITY|||||||0.2879|||||||Hodges-Lehmann method|||||||0.2879
71907179|NCT03011450|143336798|SUPERIORITY|||||||0.9786|||||||Hodges-Lehmann method|||||||0.9786
71907180|NCT03011450|143336799|SUPERIORITY|||||||0.0075|||||||Hodges-Lehmann method|||||||0.0075
71907181|NCT03011450|143336800|SUPERIORITY|||||||0.0241|||||||Hodges-Lehmann method|||||||0.0241
71907182|NCT03011450|143336801|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907183|NCT03011450|143336802|SUPERIORITY|||||||0.0502|||||||Hodges-Lehmann method|||||||0.0502
71907184|NCT03011450|143336803|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907185|NCT03011450|143336804|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<.0001
71907186|NCT03011450|143336805|SUPERIORITY|||||||0.0209|||||||Hodges-Lehmann method|||||||0.0209
71688700|NCT02634983|142892848|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.36||0.982|TWO_SIDED|90.0|-0.62|0.6|||t-test, 2 sided|||Lung Clearance Index||0.60|-0.62|0.9820
71688701|NCT02634983|142892849|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.36||0.0821|TWO_SIDED|90.0|0.04|1.27|||t-test, 2 sided|||Diffusion Capacity of Lung for CO||1.27|0.04|0.0821
71907187|NCT03011450|143336806|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907188|NCT03011450|143336807|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907189|NCT03011450|143336808|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907190|NCT03011450|143336809|SUPERIORITY||||||<|0.0001|||||||non-parametric Hodges-Lehmann method|||||||<0.0001
71907191|NCT03011450|143336810|SUPERIORITY|||||||0.0001|||||||Hodges-Lehmann method|||||||0.0001
71907192|NCT03011450|143336811|SUPERIORITY||||||<|0.0001|||||||Hodges-Lehmann method|||||||<0.0001
71907193|NCT03519516|143336878|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.749|||||||Wilcoxon (Mann-Whitney)|||||||0.749
71907194|NCT03519516|143336879|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.041|||||||Chi-squared|||||||0.041
71907195|NCT03519516|143336880|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.694|||||||Wilcoxon (Mann-Whitney)|||||||0.694
71907196|NCT03519516|143336881|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.495|||||||Wilcoxon (Mann-Whitney)|||||||0.495
71907197|NCT03519516|143336882|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.492||||||statistical analysis between groups for final visit with green lissamine|Chi-squared|||||||0.492
71907198|NCT03519516|143336882|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.238||||||statistical analysis between groups for final visit with fluorescein|Chi-squared, Corrected|||||||0.238
71907199|NCT03519516|143336883|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.213|||||||Chi-squared|||||||0.213
71907200|NCT03519516|143336885|NON_INFERIORITY|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.741|||||||Chi-squared, Corrected|||||||0.741
71907201|NCT03519516|143336887|NON_INFERIORITY|The study drug is considered non-inferior with respect to the comparator if there are no differences above twenty percent||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.110
71907202|NCT01529385|143336893|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907203|NCT01529385|143336894|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<0.05
71907204|NCT01529385|143336895|SUPERIORITY_OR_OTHER||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||<.05
71907205|NCT01529385|143336896|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907206|NCT01529385|143336897|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907207|NCT01529385|143336898|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907208|NCT01529385|143336900|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907209|NCT01529385|143336901|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907210|NCT01529385|143336902|SUPERIORITY_OR_OTHER||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA|||||||>0.05
71907211|NCT00321269|143336903|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Mixed Models Analysis|||Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P\>F=0.90.||||0.90
71907212|NCT00321269|143336904|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Mixed Models Analysis|F(2,110)=2.08; P=0.13||||||0.13
71907213|NCT04009213|143336937|NON_INFERIORITY|H0: δT - δC ≥ 0.9 Ha: δT - δC \< 0.9|||||<|0.025|ONE_SIDED|95.0|||||ANCOVA|||||||< 0.025
71907214|NCT04009213|143336938|NON_INFERIORITY|H0: qT - qC ≥ 10% H1: qT - qC \< 10%|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
71907215|NCT04009213|143336939|NON_INFERIORITY|H0: pC - pT ≥ 10% H1: pC - pT \< 10%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||<0.025
71907216|NCT04009213|143336940|NON_INFERIORITY|H0: πC - πT ≥ 15% H1: πC - πT \< 15%,|||||<|0.025|ONE_SIDED|95.0|||||Farrington-Manning|||||||< 0.025
71922044|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.1|11.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.7|-5.1|
71681441|NCT00435487|142881344|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-1.35||||||95.0|-8.62|5.93|||upper limit of 95% CI <= 10%||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).||5.93|-8.62|
71860551|NCT02641587|143235937|OTHER|"The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|85.01|||<|0.001|TWO_SIDED|95.0|82.06|87.47||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.||87.47|82.06|<0.001
71860552|NCT02641587|143235938|OTHER|"The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|40.2|||<|0.001|TWO_SIDED|95.0|30.25|48.73||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.||48.73|30.25|<0.001
71860553|NCT02641587|143235939|OTHER|"The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|83.9|||<|0.001|TWO_SIDED|95.0|81.61|85.9||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.||85.90|81.61|<0.001
71860554|NCT02641587|143235940|OTHER|"The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|55.74|||<|0.001|TWO_SIDED|95.0|49.03|61.56||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.||61.56|49.03|<0.001
71907217|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.42|STANDARD_ERROR_OF_MEAN|3.11|<|0.001|TWO_SIDED|95.0|-77.55|-65.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.29|-77.55|<0.001
71922045|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|3.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-5.4|11.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 8, pre-dose PM||11.3|-5.4|
71681442|NCT00435487|142881345|SUPERIORITY_OR_OTHER||Difference in proportion|1.27||||1||95.0|-1.2|3.73|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||3.73|-1.20|1.0000
71681443|NCT00435487|142881346|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
71907218|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.16|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-65.94|-52.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-52.38|-65.94|<0.001
71907219|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.6|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-45.81|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.40|-45.81|<0.001
71907220|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.1|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-47.83|-34.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-34.37|-47.83|<0.001
71907221|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-76.29|STANDARD_ERROR_OF_MEAN|5.36|<|0.001|TWO_SIDED|95.0|-86.87|-65.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.72|-86.87|<0.001
71907222|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.51|STANDARD_ERROR_OF_MEAN|4.72|<|0.001|TWO_SIDED|95.0|-79.81|-61.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.20|-79.81|<0.001
71907223|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.2|STANDARD_ERROR_OF_MEAN|5.24|<|0.001|TWO_SIDED|95.0|-57.54|-36.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.86|-57.54|<0.001
71907224|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.88|STANDARD_ERROR_OF_MEAN|4.73|<|0.001|TWO_SIDED|95.0|-48.21|-29.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-29.56|-48.21|<0.001
71907225|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.21|STANDARD_ERROR_OF_MEAN|3.3|<|0.001|TWO_SIDED|95.0|-74.72|-61.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.70|-74.72|<0.001
71907226|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.49|STANDARD_ERROR_OF_MEAN|3.21|<|0.001|TWO_SIDED|95.0|-70.84|-58.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.14|-70.84|<0.001
71681444|NCT00435487|142881347|SUPERIORITY_OR_OTHER||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).||5.95|-6.05|1.0000
71860555|NCT02641587|143235941|OTHER|"The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC \> 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|79.36|||<|0.001|TWO_SIDED|95.0|72.73|84.39||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC \[%\]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.||84.39|72.73|<0.001
71860556|NCT01165177|143235942|OTHER|Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|96.6|||<|0.0001|TWO_SIDED|95.0|89.6|99.3||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||99.3|89.6|<0.0001
71860557|NCT01165177|143235942|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.4|||<|0.0001|TWO_SIDED|95.0|90.1|99.7||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group||99.7|90.1|<0.0001
71907227|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.31|STANDARD_ERROR_OF_MEAN|4.42|<|0.001|TWO_SIDED|95.0|-77.04|-59.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-59.57|-77.04|<0.001
71907228|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.98|STANDARD_ERROR_OF_MEAN|5.23|<|0.001|TWO_SIDED|95.0|-65.31|-44.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.65|-65.31|<0.001
71907229|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-70.56|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-76.72|-64.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.41|-76.72|<0.001
71860558|NCT01165177|143235942|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.9||||0.0001|TWO_SIDED|95.0|87.9|100.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|87.9|0.0001
71860559|NCT01165177|143235942|OTHER|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.2|||<|0.0001|TWO_SIDED|95.0|93.7|99.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group||99|93.7|<0.0001
71860560|NCT01165177|143235943|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0081|TWO_SIDED|95.0|40.9|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group||100|40.9|0.0081
71860561|NCT01165177|143235943|OTHER|Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.5097|TWO_SIDED|95.0|-442.8|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group||100|-442.8|0.5097
71860562|NCT01165177|143235943|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0||||0.0078|TWO_SIDED|95.0|41.4|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group||100|41.4|0.0078
71860563|NCT01165177|143235943|OTHER|Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0001|TWO_SIDED|95.0|77.1|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group||100|77.1|<0.0001
71860564|NCT01663506|143235970|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 3||||<0.01
71860565|NCT01663506|143235970|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
71681445|NCT03301844|142881352|SUPERIORITY|||||||0.071|||||||Chi-squared||||"Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.~Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion."|||0.071
71860566|NCT01663506|143235970|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71860567|NCT01663506|143235972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
71860568|NCT01663506|143235972|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
71860569|NCT01663506|143235973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
71860570|NCT01663506|143235973|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.0001
71860571|NCT01663506|143235975|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
71860572|NCT01663506|143235975|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71860573|NCT01663506|143235976|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71860574|NCT01663506|143235978|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.001
71860575|NCT01663506|143235978|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71860576|NCT01663506|143235979|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.05
71907230|NCT01763866|143336949|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.41|STANDARD_ERROR_OF_MEAN|4.41|<|0.001|TWO_SIDED|95.0|-69.11|-51.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.72|-69.11|<0.001
71922046|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-6.1|9.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.1|-6.1|
71860577|NCT01663506|143235979|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.01
71860578|NCT01663506|143235981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 6||||<0.01
71860579|NCT01663506|143235981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 6||||<0.01
71860580|NCT01663506|143235981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 12||||<0.001
71860581|NCT01663506|143235981|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 12||||<0.01
71860582|NCT01663506|143235982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
71860583|NCT01663506|143235982|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
71860584|NCT01663506|143235983|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6||||<0.01
71860585|NCT01663506|143235983|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12||||<0.001
71860586|NCT00476242|143236001|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||||||.047
71860587|NCT02270671|143236003|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
71860588|NCT02270671|143236004|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.026|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
71860589|NCT02270671|143236005|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \>.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
71860590|NCT02270671|143236006|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: \<.0001|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
71860591|NCT02270671|143236007|SUPERIORITY_OR_OTHER||||||>|0.05||||||Group x Time interaction p-value: \>.05; Gender p-value: =.007|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p \< .025.||||||>.05
71860592|NCT05878873|143236045|OTHER||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.027||0.007|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44.|This estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.007
71860593|NCT05878873|143236045|OTHER||Mean Difference (Net)|-0.089|STANDARD_ERROR_OF_MEAN|0.032||0.008|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF.|Statistical analysis comparing cortical activation between TENS ON and TENS OFF conditions in healthy controls.||||0.008
71922047|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-5.3|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 9, pre-dose AM||9.9|-5.3|
71860594|NCT05878873|143236046|OTHER||Mean Difference (Net)|0.042|STANDARD_ERROR_OF_MEAN|0.0141||0.014|TWO_SIDED|||||This value was adjusted using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|This estimate calculation is TENS ON - TENS OFF at Visit 2.|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.014
71860595|NCT05878873|143236046|OTHER||Mean Difference (Net)|-0.0058|STANDARD_ERROR_OF_MEAN|0.167||0.878|TWO_SIDED|||||This value was corrected with false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF at Visit 2|Statistical analysis comparing savings between TENS ON and TENS OFF conditions in healthy controls.||||0.878
71860596|NCT05878873|143236047|OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.018||0.898|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in people with multiple sclerosis.||||0.898
71860597|NCT05878873|143236047|OTHER||Mean Difference (Final Values)|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.698|TWO_SIDED|||||This value was corrected using false discovery rate.|Mixed Models Analysis|Degrees of freedom = 44|The estimate calculation is TENS ON - TENS OFF|Statistical analysis comparing rate of adaptation between TENS ON and TENS OFF conditions in healthy controls.||||0.698
71860598|NCT00882115|143236057|OTHER||||||<|0.001|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.||||<0.001
71860599|NCT00882115|143236057|OTHER||||||<|0.01|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.||||<0.01
71860600|NCT03865953|143236058|SUPERIORITY|Analysis used a two-period two-treatment crossover design|Mean Difference (Net)|-0.14||||0.67|TWO_SIDED|95.0|-0.76|0.49|||Mixed Models Analysis|||Subject numbers gave a 90% power to demonstrate a statistically significant difference in the mean change from baseline NPRS for the active treatment compared with placebo of at least 1 unit, with a two sided test at a 5% level of significance||0.49|-0.76|0.67
71681446|NCT03301844|142881353|OTHER|||||||0.7353|||||||Chi-squared||||"The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.~Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test."|||0.7353
71860601|NCT02552147|143236073|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||.44
71860602|NCT02552147|143236074|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.38
71860603|NCT02552147|143236078|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
71860604|NCT02552147|143236079|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.13
71860605|NCT02552147|143236080|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.50
71860606|NCT02552147|143236081|SUPERIORITY|||||||1||||||P value was calculated to \>0.99 and thus rounded to 1.0.|Wilcoxon (Mann-Whitney)|Two-tailed||||||1.0
71860607|NCT02552147|143236082|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Two-tailed||||||0.25
71860608|NCT02552147|143236083|SUPERIORITY|||||||0.69|||||||Binomial test|||||||0.69
71860609|NCT00745498|143236106|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||With study power of 80%, a significance level of 0.05, and the assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated.||||<0.05
71860610|NCT02353871|143236143|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71860611|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 8 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71860612|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 15 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71860613|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 57 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71860614|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 85 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71860615|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 113 - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71860616|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 148 - BTX-A-HAC NG solution (50 U) versus placebo||||0.0035
71907231|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.95|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-75.38|-64.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.51|-75.38|<0.001
71907232|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|-69.06|-56.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-56.57|-69.06|<0.001
71907233|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.53|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-43.03|-32.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-32.03|-43.03|<0.001
71907234|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.49|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-49.7|-37.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-37.28|-49.70|<0.001
71907235|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.92|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-84.49|-65.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-65.35|-84.49|<0.001
71907236|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-74.81|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-83.0|-66.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-66.62|-83.00|<0.001
71907237|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.95|STANDARD_ERROR_OF_MEAN|4.75|<|0.001|TWO_SIDED|95.0|-54.32|-35.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.57|-54.32|<0.001
71907238|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.81|STANDARD_ERROR_OF_MEAN|4.19|<|0.001|TWO_SIDED|95.0|-52.06|-35.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.55|-52.06|<0.001
71907239|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.88|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-72.67|-61.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-61.08|-72.67|<0.001
71907240|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.58|STANDARD_ERROR_OF_MEAN|3.05|<|0.001|TWO_SIDED|95.0|-72.6|-60.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.56|-72.60|<0.001
71681447|NCT01267201|142881358|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.11|||||TWO_SIDED|90.0|88.23|96.15||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||96.15|88.23|
71688702|NCT03749109|142892868|OTHER||Difference in LS mean|1.74||||0.78|TWO_SIDED|95.0|-10.45|13.94|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.94|-10.45|0.78
71907241|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.66|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-73.19|-58.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-58.12|-73.19|<0.001
71907242|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.91|STANDARD_ERROR_OF_MEAN|4.27|<|0.001|TWO_SIDED|95.0|-71.37|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.46|-71.37|<0.001
71907243|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.43|STANDARD_ERROR_OF_MEAN|2.74|<|0.001|TWO_SIDED|95.0|-74.86|-64.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-64.01|-74.86|<0.001
71907244|NCT01763866|143336950|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-68.45|STANDARD_ERROR_OF_MEAN|4.17|<|0.001|TWO_SIDED|95.0|-76.68|-60.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.22|-76.68|<0.001
71907245|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-83.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-92.6|-74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-74.6|-92.6|<0.001
71907246|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.7|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-90.2|-69.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-69.2|-90.2|<0.001
71907247|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.4|STANDARD_ERROR_OF_MEAN|4.4|<|0.001|TWO_SIDED|95.0|-53.4|-35.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.3|-53.4|<0.001
71907248|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-65.4|-44.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.6|-65.4|<0.001
71907249|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-69.9|STANDARD_ERROR_OF_MEAN|6.1|<|0.001|TWO_SIDED|95.0|-81.9|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.8|-81.9|<0.001
71907250|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-74.5|-56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.7|-74.5|<0.001
71907251|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-57.7|-33.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.9|-57.7|<0.001
71907252|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.8|STANDARD_ERROR_OF_MEAN|4.5|<|0.001|TWO_SIDED|95.0|-47.8|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.9|-47.8|<0.001
71907253|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.4|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-83.9|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.0|-83.9|<0.001
71922048|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-4.0|12.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose||12.6|-4.0|
71688703|NCT03749109|142892868|OTHER||Difference in LS mean|3.35||||0.29|TWO_SIDED|95.0|-2.89|9.59|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||9.59|-2.89|0.29
71688704|NCT03749109|142892868|OTHER||Difference in LS mean|0.33||||0.95|TWO_SIDED|95.0|-10.33|10.99|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||10.99|-10.33|0.95
71907254|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.9|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-88.0|-67.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.8|-88.0|<0.001
71681448|NCT01267201|142881358|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.22|||||TWO_SIDED|90.0|86.49|94.11||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||94.11|86.49|
71688705|NCT03749109|142892869|OTHER||Difference in LS mean|-6.99||||0.65|TWO_SIDED|95.0|-36.8|22.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||22.82|-36.80|0.65
71860617|NCT02353871|143236144|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0441||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 183 (End of Study) - BTX-A-HAC NG solution (50 U) versus placebo||||0.0441
71860618|NCT02353871|143236145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2422||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 57 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.2422
71860619|NCT02353871|143236145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0917||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 85 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.0917
71860620|NCT02353871|143236145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7064||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 113 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7064
71860621|NCT02353871|143236145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 148 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7010
71860622|NCT02353871|143236145|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7894||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 183 - BTX-A-HAC NG solution (50 U) versus Placebo||||0.7894
71860623|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
71860624|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
71860625|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71860626|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
71860627|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
71860628|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
71860629|NCT02353871|143236146|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0015||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0015
71860630|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
71860631|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
71860632|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71681449|NCT01267201|142881359|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|94.76|||||TWO_SIDED|90.0|88.06|101.98||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||101.98|88.06|
71860633|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
71860634|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||0.0008
71860635|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||0.0065
71860636|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0643||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0643
71860637|NCT02353871|143236147|SUPERIORITY_OR_OTHER_LEGACY|||||||0.367||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.3670
71860638|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
71681450|NCT01267201|142881359|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|83.89|||||TWO_SIDED|90.0|78.06|90.17||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||90.17|78.06|
71860639|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
71860640|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71860641|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
71860642|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - Dysport 50 U versus Placebo at Day 85||||<0.0001
71860643|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
71860644|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||0.0011
71860645|NCT02353871|143236148|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0036||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||0.0036
71907255|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-63.1|-48.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.4|-63.1|<0.001
71907256|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|5.1|<|0.001|TWO_SIDED|95.0|-60.6|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.6|-60.6|<0.001
71681451|NCT00501059|142881362|SUPERIORITY_OR_OTHER|||||||0.597|||||||Log Rank|||Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.||||0.597
71681452|NCT00501059|142881363|SUPERIORITY_OR_OTHER|||||||0.6125|||||||Log Rank|||Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.6125
71681453|NCT00501059|142881364|SUPERIORITY_OR_OTHER|||||||0.4505|||||||Log Rank|||Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4505
71860646|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8||||<0.0001
71860647|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15||||<0.0001
71860648|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29||||<0.0001
71860649|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57||||<0.0001
71860650|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85||||<0.0001
71860651|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113||||<0.0001
71860652|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148||||<0.0001
71860653|NCT02353871|143236149|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183||||<0.0001
71860654|NCT02353871|143236150|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus Placebo||||<0.0001
71860655|NCT02353871|143236150|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|6.561|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|Centre, gender and ILA baseline severity score used as covariates.||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus placebo||||<0.0001
71860656|NCT03434028|143236158|SUPERIORITY||difference in mortality rate|-0.9||||0.61|TWO_SIDED|95.0|-4.4|2.6|||Z-test|||||2.6|-4.4|0.61
71681454|NCT00501059|142881364|SUPERIORITY_OR_OTHER|||||||0.229|||||||Log Rank|||Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.229
71681455|NCT00501059|142881364|SUPERIORITY_OR_OTHER|||||||0.3947|||||||Log Rank|||Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.3947
71860657|NCT03434028|143236159|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||The mean values is an estimate from the Kaplan-Meier curve, thus it is correct as reported.|||1.2|-0.5|
71860658|NCT03434028|143236160|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-0.4|1.6||||||||1.6|-0.4|
71860659|NCT03434028|143236161|SUPERIORITY||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-0.8|1.2||||||||1.2|-0.8|
71860660|NCT03434028|143236162|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.5|1.3||||||||1.3|-0.5|
71860661|NCT03434028|143236163|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.8|1.0||||||||1.0|-0.8|
71860662|NCT03434028|143236164|SUPERIORITY||Mean Difference (Final Values)|0.8|||||TWO_SIDED|95.0|-0.3|1.9||||||||1.9|-0.3|
71860663|NCT03434028|143236165|SUPERIORITY||Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-5.1|1.7||||||||1.7|-5.1|
71860664|NCT03434028|143236166|SUPERIORITY||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-1.8|1.8||||||||1.8|-1.8|
71860665|NCT03434028|143236167|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
71860666|NCT03434028|143236168|SUPERIORITY||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.3|0.4||||||||0.4|-0.3|
71860667|NCT03434028|143236169|SUPERIORITY||Risk Difference (RD)|-0.1|||||TWO_SIDED|95.0|-1.7|1.5||||||||1.5|-1.7|
71860668|NCT03434028|143236170|SUPERIORITY||Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-3.7|1.7||||||||1.7|-3.7|
71860669|NCT03434028|143236171|SUPERIORITY||Risk Difference (RD)|0.5|||||TWO_SIDED|95.0|-3.6|4.7||||||||4.7|-3.6|
71860670|NCT02037776|143236172|SUPERIORITY|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups in Rikkunshito Placebo and Rikkunshito, based on the count of participants categorized in 1 (Significantly improved) through 7 (Much worse), using the Wilcoxon (Mann-Whitney).||||0.038
71860671|NCT02037776|143236173|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in all symptoms of modified FSSG||||0.027
71860672|NCT02037776|143236173|SUPERIORITY|||||||0.089|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in GERD symptoms of modified FSSG||||0.089
71860673|NCT02037776|143236173|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in dyspeptic symptoms of modified FSSG||||0.148
71860674|NCT02037776|143236174|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in total score of PAGI-SYM||||0.051
71860675|NCT02037776|143236174|SUPERIORITY|||||||0.947|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Heartburn/Regurgitation of PAGI-SYM||||0.947
71860676|NCT02037776|143236174|SUPERIORITY|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Nausea/Vomiting of PAGI-SYM||||0.157
71860677|NCT02037776|143236174|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM||||0.004
71860678|NCT02037776|143236174|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Bloating of PAGI-SYM||||0.011
71860679|NCT02037776|143236174|SUPERIORITY|||||||0.245|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Upper Abdominal Pain of PAGI-SYM||||0.245
71860680|NCT02037776|143236174|SUPERIORITY|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Lower Abdominal Pain of PAGI-SYM||||0.387
71860681|NCT02037776|143236175|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||||||0.034
71860682|NCT02037776|143236176|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in PCS of SF-8||||0.270
71860683|NCT02037776|143236176|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in MCS of SF-8||||0.342
71860684|NCT02037776|143236177|SUPERIORITY|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in overall point score of HAD||||0.036
71860685|NCT02037776|143236177|SUPERIORITY|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in depression point score of HAD||||0.084
71860686|NCT02037776|143236177|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in anxiety point score of HAD||||0.022
71860687|NCT01963169|143236178|SUPERIORITY||Effect size|0.54|||<|0.001|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for Knowledge outcome using the revised Osteoporosis Knowledge Test.|At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.||||< 0.001
71860688|NCT01963169|143236178|SUPERIORITY||Effect size|0.33|||<|0.001|TWO_SIDED|||||\<0.05 (threshold)|Mixed Models Analysis||The above values are for the exercise behavior variable assessed by the 9-item Self-Efficacy for Exercise scale.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||<0.001
71860689|NCT01963169|143236178|SUPERIORITY||Effect size|0.2||||0.009|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for calcium outcome expectation..|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.009
71860690|NCT01963169|143236178|SUPERIORITY||Effect Size|0.18||||0.002|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise self-efficacy.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.002
71860691|NCT01963169|143236178|SUPERIORITY||Effect size|0.14||||0.032|TWO_SIDED|||||\<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise outcome expectation.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.||||0.032
71860692|NCT03786744|143236186|SUPERIORITY||Mean Difference (Net)|9.0||||0.049367|TWO_SIDED|||||Alternative hypothesis: can be changed of speech, language, communication skills for Cord Blood versus Placebo groups in 2-month Threshold \<0.05|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.049367
71860693|NCT03786744|143236186|SUPERIORITY||Median Difference (Net)|9.0||||0.004072|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Health/Physical Development/Behaviour for Cord Blood versus Control groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.004072
71907257|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-78.1|STANDARD_ERROR_OF_MEAN|4.1|<|0.001|TWO_SIDED|95.0|-86.2|-70.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.0|-86.2|<0.001
71907258|NCT01763866|143336951|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.1|STANDARD_ERROR_OF_MEAN|5.8|<|0.001|TWO_SIDED|95.0|-91.7|-68.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-68.6|-91.7|<0.001
71907259|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-85.5|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-95.2|-75.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-75.9|-95.2|<0.001
71907260|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-86.8|-64.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-64.9|-86.8|<0.001
71907261|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.8|STANDARD_ERROR_OF_MEAN|4.9|<|0.001|TWO_SIDED|95.0|-56.6|-37.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.1|-56.6|<0.001
71907262|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|5.5|<|0.001|TWO_SIDED|95.0|-62.6|-40.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.9|-62.6|<0.001
71907263|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.7|STANDARD_ERROR_OF_MEAN|6.4|<|0.001|TWO_SIDED|95.0|-84.4|-59.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-59.0|-84.4|<0.001
71907264|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-71.6|-52.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.0|-71.6|<0.001
71907265|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.0|STANDARD_ERROR_OF_MEAN|6.3|<|0.001|TWO_SIDED|95.0|-61.5|-36.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.6|-61.5|<0.001
71907266|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.3|STANDARD_ERROR_OF_MEAN|5.0|<|0.001|TWO_SIDED|95.0|-45.2|-25.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.5|-45.2|<0.001
71907267|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.1|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-86.2|-67.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-67.9|-86.2|<0.001
71907268|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-75.8|STANDARD_ERROR_OF_MEAN|5.3|<|0.001|TWO_SIDED|95.0|-86.3|-65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-65.3|-86.3|<0.001
71907269|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-65.1|-49.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.4|-65.1|<0.001
71681456|NCT00501059|142881364|SUPERIORITY_OR_OTHER|||||||0.5125|||||||Log Rank|||Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.5125
71907270|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.001|TWO_SIDED|95.0|-55.9|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.4|-55.9|<0.001
71681457|NCT00501059|142881365|SUPERIORITY_OR_OTHER|||||||0.9544|||||||Log Rank|||Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.9544
71681458|NCT00501059|142881365|SUPERIORITY_OR_OTHER|||||||0.4422|||||||Log Rank|||Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.4422
71860694|NCT03786744|143236186|SUPERIORITY||Mean Difference (Net)|9.0||||0.017258|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Health/Physical Development/Behaviour for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.||||0.017258
71860695|NCT03786744|143236186|SUPERIORITY||Mean Difference (Net)|10.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 1-month of total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
71860696|NCT03786744|143236186|SUPERIORITY||Mean Difference (Net)|24.0||||0.00194|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 2-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.001940
71860697|NCT03786744|143236186|SUPERIORITY||Mean Difference (Net)|15.0||||0.03121|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 6-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.031210
71681459|NCT00501059|142881365|SUPERIORITY_OR_OTHER|||||||0.611|||||||Log Rank|||Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||||0.611
71681460|NCT00501059|142881366|OTHER||Cox Proportional Hazard|0.99||||0.9459|TWO_SIDED|95.0|0.8|1.24|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.24|0.80|0.9459
71681461|NCT00501059|142881367|OTHER||Cox Proportional Hazard|0.85||||0.2325|TWO_SIDED|95.0|0.64|1.11|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.11|0.64|0.2325
71860698|NCT03786744|143236186|SUPERIORITY||Mean Difference (Net)|16.0||||0.01133|TWO_SIDED|||||"Alternative hypothesis: can be changed average of 12-month of Total score for Cord Blood versus Placebo groups.~Threshold \<0.05"|Wilcoxon (Mann-Whitney)|||The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile||||0.011330
71907271|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.0|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-87.5|-70.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-70.4|-87.5|<0.001
71681462|NCT00501059|142881367|OTHER||Cox Proportional Hazard|1.12||||0.5072||95.0|0.8|1.55|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.55|0.80|0.5072
71681463|NCT00501059|142881367|OTHER||Cox Proportional Hazard|0.97||||0.901||95.0|0.62|1.52|||Log Rank|||Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.52|0.62|0.9010
71681464|NCT00501059|142881367|OTHER||Cox Proportional Hazard|1.0||||0.9979|TWO_SIDED|95.0|0.54|1.86|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.86|0.54|0.9979
71681465|NCT00501059|142881367|OTHER||Cox Proportional Hazard|0.93||||0.7455|TWO_SIDED|95.0|0.61|1.42|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.42|0.61|0.7455
71681466|NCT00501059|142881369|OTHER||Cox Proportional Hazard|0.96||||0.6038|TWO_SIDED|95.0|0.81|1.13|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.13|0.81|0.6038
71681467|NCT00501059|142881369|OTHER||Cox Proportional Hazard|0.95||||0.619|TWO_SIDED|95.0|0.79|1.15|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.15|0.79|0.6190
71681468|NCT00501059|142881369|OTHER||Cox Proportional Hazard|0.9||||0.4562|TWO_SIDED|95.0|0.67|1.2|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.20|0.67|0.4562
71681469|NCT00501059|142881370|OTHER||Cox Proportional Hazard|0.81||||0.0756|TWO_SIDED|95.0|0.64|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.64|0.0756
71860699|NCT04683510|143236199|SUPERIORITY||Odds Ratio (OR)|1.647||||0.2345|TWO_SIDED|95.0|0.724|3.746|||Regression, Logistic|||||3.746|0.724|0.2345
71860700|NCT04683510|143236199|SUPERIORITY||Odds Ratio (OR)|1.897||||0.124|TWO_SIDED|95.0|0.839|4.291|||Regression, Logistic|||||4.291|0.839|0.124
71860701|NCT04683510|143236200|SUPERIORITY||Odds Ratio (OR)|0.905||||0.2352|TWO_SIDED|95.0|0.768|1.067|||Regression, Logistic|||||1.067|0.768|0.2352
71860702|NCT04683510|143236200|SUPERIORITY||Odds Ratio (OR)|0.924||||0.3418|TWO_SIDED|95.0|0.785|1.088|||Regression, Logistic|||||1.088|0.785|0.3418
71860703|NCT04683510|143236201|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1653|TWO_SIDED|95.0|0.921|1.615|||Regression, Logistic|||||1.615|0.921|0.1653
71860704|NCT04683510|143236201|SUPERIORITY||Odds Ratio (OR)|1.213||||0.181|TWO_SIDED|95.0|0.914|1.609|||Regression, Logistic|||||1.609|0.914|0.181
71860705|NCT02353312|143236213|EQUIVALENCE|Pairwise comparisons of VO2 max means with equal variances between participant on and off treatment.||||||0.823|||||||t-test, 2 sided|||||||0.823
71860706|NCT03522389|143236215|SUPERIORITY|||||||0.003|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.003
71860707|NCT03522389|143236215|SUPERIORITY||||||<|0.001|||||||ANOVA|||1-month follow up - Baseline (T3-T1)||||<0.001
71860708|NCT03522389|143236215|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71860709|NCT03522389|143236215|SUPERIORITY|||||||0.006|||||||ANOVA|||Within group comparison||||0.006
71681470|NCT00501059|142881370|OTHER||Cox Proportional Hazard|0.79||||0.0661|TWO_SIDED|95.0|0.61|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.02|0.61|0.0661
71860710|NCT03522389|143236215|SUPERIORITY|||||||0.793|||||||ANOVA|||Within group comparison||||0.793
71860711|NCT03522389|143236216|SUPERIORITY||||||<|0.001|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||<0.001
71860712|NCT03522389|143236216|SUPERIORITY|||||||0.039|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.039
71860713|NCT03522389|143236216|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71860714|NCT03522389|143236216|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
71860715|NCT03522389|143236216|SUPERIORITY|||||||0.117|||||||ANOVA|||Within group comparison||||0.117
71860716|NCT03522389|143236217|SUPERIORITY|||||||0.924|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.924
71860717|NCT03522389|143236217|SUPERIORITY|||||||0.855|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.855
71860718|NCT03522389|143236217|SUPERIORITY|||||||0.937|||||||ANOVA|||Within group comparison||||0.937
71860719|NCT03522389|143236217|SUPERIORITY|||||||0.97|||||||ANOVA|||Within group comparison||||0.970
71860720|NCT03522389|143236217|SUPERIORITY|||||||0.242|||||||ANOVA|||Within group comparison||||0.242
71860721|NCT03522389|143236218|SUPERIORITY|||||||0.161|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.161
71860722|NCT03522389|143236218|SUPERIORITY|||||||0.161|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.161
71860723|NCT03522389|143236218|SUPERIORITY|||||||0.076|||||||ANOVA|||Within group comparison||||0.076
71860724|NCT03522389|143236218|SUPERIORITY|||||||0.211|||||||ANOVA|||Within group comparison||||0.211
71860725|NCT03522389|143236218|SUPERIORITY|||||||0.573|||||||ANOVA|||Within group comparison||||0.573
71860726|NCT03522389|143236219|SUPERIORITY|||||||0.445|||||||ANOVA|||After 4 weeks of training - Baseline (T2-T1)||||0.445
71860727|NCT03522389|143236219|SUPERIORITY|||||||0.046|||||||ANOVA|||1-month follow-up - Baseline (T3-T1)||||0.046
71860728|NCT03522389|143236219|SUPERIORITY||||||<|0.001|||||||ANOVA|||Within group comparison||||<0.001
71860729|NCT03522389|143236219|SUPERIORITY|||||||0.028|||||||ANOVA|||Within group comparison||||0.028
71860730|NCT03522389|143236219|SUPERIORITY|||||||0.002|||||||ANOVA|||Within group comparison||||0.002
71860731|NCT02242643|143236282|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|Seroconversion rate (SCR) Difference (%)|-6.32|||||TWO_SIDED|95.0|-10.34|-2.27|||||For A/California/7/2009 (H1N1) vaccine strain.|||-2.27|-10.34|
71860732|NCT02242643|143236282|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-6.74|||||TWO_SIDED|95.0|-10.68|-2.8|||||For A/Texas/50/2012 (H3N2) vaccine strain|||-2.80|-10.68|
71860733|NCT02242643|143236282|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-16.38|||||TWO_SIDED|95.0|-20.68|-12.02|||||For B/Massachusetts/2/2012 (Yamagata) vaccine strain|||-12.02|-20.68|
71860734|NCT02242643|143236282|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-11.75|||||TWO_SIDED|95.0|-15.28|-8.21|||||For B/Brisbane/60/2008 (Victoria) vaccine strain.|||-8.21|-15.28|
71860735|NCT02242643|143236283|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.77|0.95|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.95|0.77|
71860736|NCT02242643|143236283|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.94|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.94|0.77|
71860737|NCT02242643|143236283|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.65|||||TWO_SIDED|95.0|0.59|0.71|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.71|0.59|
71860738|NCT02242643|143236283|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.62|||||TWO_SIDED|95.0|0.56|0.69|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|||0.69|0.56|
71860739|NCT02633397|143236306|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.19
71860740|NCT02633397|143236307|SUPERIORITY|||||||0.42|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.42
71860741|NCT02633397|143236308|SUPERIORITY|||||||0.52|||||||Regression, Logistic|||P- Value was the exact logistic regression adjusted for clinical site.||||0.52
71860742|NCT02633397|143236310|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.69|TWO_SIDED|90.0|-0.7|0.42|||ANCOVA|||ANCOVA model adjusted for clinic site||0.42|-0.70|0.69
71860743|NCT02633397|143236311|SUPERIORITY||Mean Difference (Final Values)|-39.51||||0.4|TWO_SIDED|90.0|-117.05|38.02|||ANCOVA|||ANCOVA model adjusted for clinic site||38.02|-117.05|0.40
71860744|NCT02633397|143236312|SUPERIORITY||Mean Difference (Final Values)|0.31||||0.23|TWO_SIDED|90.0|-0.11|0.73|||Regression, Linear|||Linear regression model adjusted for clinic site||0.73|-0.11|0.23
71860745|NCT02633397|143236313|SUPERIORITY||Mean Difference (Final Values)|-0.08||||-0.8|TWO_SIDED|90.0|-0.62|0.46|||ANCOVA|||ANCOVA model adjusted for clinic site||0.46|-0.62|-0.80
71860746|NCT02633397|143236314|SUPERIORITY||Mean Difference (Final Values)|-6.96|||<|0.001|TWO_SIDED|90.0|-10.22|-3.69|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in MAP as a function of time, the interaction between time and study arm, and clinic site.||-3.69|-10.22|<0.001
71860747|NCT02633397|143236315|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.15|TWO_SIDED|90.0|-0.31|0.02|||ANCOVA|||ANCOVA model adjusted for clinic site||0.02|-0.31|0.15
71860748|NCT02633397|143236316|SUPERIORITY||Mean Difference (Final Values)|-6.7||||0.003|TWO_SIDED|90.0|-10.28|-3.12|||ANCOVA|||ANCOVA model adjusted for clinic site||-3.12|-10.28|0.003
71860749|NCT02633397|143236317|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|90.0|2.0|5.04|||ANCOVA|||ANCOVA model adjusted for clinic site||5.04|2.00|<0.001
71860750|NCT02633397|143236318|SUPERIORITY||Mean Difference (Final Values)|286.56||||0.51|TWO_SIDED|90.0|-429.86|1002.99|||Regression, Linear|||Linear regression model adjusted for clinic site||1002.99|-429.86|0.51
71681471|NCT00501059|142881370|OTHER||Cox Proportional Hazard|0.53||||0.0014|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.79|0.36|0.0014
71860751|NCT02633397|143236319|SUPERIORITY||Mean Difference (Final Values)|-82.18||||0.14|TWO_SIDED|90.0|-173.69|9.32|||Regression, Linear|||Linear regression model adjusted for clinic site||9.32|-173.69|0.14
71860752|NCT02633397|143236320|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare microalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.78
71860753|NCT02633397|143236321|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare macroalbuminuria frequency as a function of time and the interaction between time and study arm.||||0.30
71860754|NCT02633397|143236322|SUPERIORITY||Mean Difference (Final Values)|-4.91||||0.06|TWO_SIDED|90.0|-9.21|-0.62|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in GFR as a function of time, the interaction between time and study arm, and clinic site.||-0.62|-9.21|0.06
71860755|NCT02633397|143236323|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||Generalized linear mixed model (logit link) with random intercept was used to compare CKD stage frequency as a function of time and the interaction between time and study arm.||||0.56
71907272|NCT01763866|143336952|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-71.9|STANDARD_ERROR_OF_MEAN|6.0|<|0.001|TWO_SIDED|95.0|-83.8|-60.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-60.0|-83.8|<0.001
71907273|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.28|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-65.29|-55.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.27|-65.29|<0.001
71860756|NCT02633397|143236324|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.15|TWO_SIDED|90.0|-0.52|0.03|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in hemoglobin as a function of time, the interaction between time and study arm, and clinic site.||0.03|-0.52|0.15
71907274|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.37|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-63.23|-51.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.51|-63.23|<0.001
71681472|NCT00501059|142881370|OTHER||Cox Proportional Hazard|0.55||||0.0056|TWO_SIDED|95.0|0.36|0.84|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||0.84|0.36|0.0056
71860757|NCT02633397|143236325|SUPERIORITY||Mean Difference (Final Values)|1.47||||0.05|TWO_SIDED|90.0|0.22|2.72|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in reticulocyte count as a function of time, the interaction between time and study arm, and clinic site.||2.72|0.22|0.05
71860758|NCT02633397|143236326|SUPERIORITY||Mean Difference (Final Values)|-0.15||||0.75|TWO_SIDED|90.0|-0.93|0.63|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||0.63|-0.93|0.75
71860759|NCT02633397|143236327|SUPERIORITY||Mean Difference (Final Values)|-29.28||||0.17|TWO_SIDED|90.0|-64.63|6.08|||Mixed Models Analysis|||Linear mixed model with random intercept was used to compare the change in WBC count as a function of time, the interaction between time and study arm, and clinic site.||6.08|-64.63|0.17
71860760|NCT02633397|143236328|SUPERIORITY||Mean Difference (Final Values)|-1.64||||0.07|TWO_SIDED|90.0|-3.13|-0.15|||Regression, Linear|||Linear regression model adjusted for clinic site||-0.15|-3.13|0.07
71860761|NCT03494985|143236332|OTHER||Least square mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.4|0.9||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.4|<0.0001
71860762|NCT03494985|143236332|OTHER||LS mean difference|0.9|||<|0.0001|TWO_SIDED|95.0|0.6|1.2||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||1.2|0.6|<0.0001
71860763|NCT03494985|143236332|OTHER||LS mean difference|0.6|||<|0.0001|TWO_SIDED|95.0|0.3|0.9||p-value was adjusted using Dunnett's method for multiple comparisons.|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.|||0.9|0.3|<0.0001
71860764|NCT03036124|143236339|SUPERIORITY||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
71681473|NCT00501059|142881370|OTHER||Cox Proportional Hazard|1.12||||0.6291||95.0|0.71|1.75|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.75|0.71|0.6291
71681474|NCT00501059|142881370|OTHER||Cox Proportional Hazard|1.03||||0.9161|TWO_SIDED|95.0|0.6|1.77|||Log Rank|||Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.77|0.60|0.9161
71907275|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.77|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-37.84|-27.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.70|-37.84|<0.001
71681475|NCT00501059|142881370|OTHER||Cox Proportional Hazard|0.75||||0.538||95.0|0.3|1.87|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.87|0.30|0.5380
71681476|NCT00501059|142881370|OTHER||Cox Proportional Hazard|1.03||||0.9181|TWO_SIDED|95.0|0.55|1.95|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.95|0.55|0.9181
71860765|NCT03036124|143236340|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001||95.0|0.65|0.85|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.85|0.65|<0.0001
71860766|NCT03036124|143236341|SUPERIORITY||Rate Ratio (RR)|0.75||||0.0002||95.0|0.65|0.88|||LWYY proportional rates model|Stratified by Type 2 Diabetes status at randomization and including the history of hospitalizations due to Heart failure as a factor.||||0.88|0.65|0.0002
71860767|NCT03036124|143236342|SUPERIORITY||Win Ratio (WR)|1.18|||<|0.0001||95.0|1.11|1.26||The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.|Win Ratio|Stratified by Type 2 Diabetes status at randomization and including baseline score as a covariate.|The composite of change from baseline in total symptom score at 8 months, or death before 8 months.|||1.26|1.11|<0.0001
71860768|NCT03036124|143236343|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.1681||95.0|0.44|1.16|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization and including baseline eGFR as a covariate.||||1.16|0.44|0.1681
71860769|NCT03036124|143236344|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.0217||95.0|0.71|0.97|||Regression, Cox|Stratified by Type 2 Diabetes status at randomization.||||0.97|0.71|0.0217
71860770|NCT02272244|143236353|SUPERIORITY||Odds Ratio (OR)|4.83|||<|0.001|TWO_SIDED|95.0|3.08|7.58|||Regression, Logistic|Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage||||7.58|3.08|<0.001
71860771|NCT02272244|143236354|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.55|9.47|||Regression, Logistic|Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.||||9.47|2.55|<0.001
71860772|NCT02272244|143236355|SUPERIORITY||||||<|0.001|||||||Regression, Multinomial|Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.|||<0.001
71907276|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.53|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-45.34|-33.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-33.71|-45.34|<0.001
71860773|NCT02272244|143236355|SUPERIORITY||Odds Ratio (OR)|4.2||||0.001|TWO_SIDED|95.0|2.63|6.7|||Odds Ratio (OR)|Stool Blood Test vs None||||6.70|2.63|0.001
71860774|NCT02272244|143236355|SUPERIORITY|Colonscopy vs None|Odds Ratio (OR)|8.79||||0.001|TWO_SIDED|95.0|4.13|18.74|||Odds Ratio (OR)|||||18.74|4.13|0.001
71860775|NCT02272244|143236356|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.862|TWO_SIDED|95.0|-0.15|0.13|||Regression, Linear|Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.|Model compares DSNI to SI.|||0.13|-0.15|0.862
71860776|NCT02272244|143236356|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.47|0.55|||Regression, Linear|Model of knowledge test score adjusts for all baseline covariates|Model compares DSNI to SI.|||.55|-.47|0.880
71860777|NCT03670277|143236357|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|-0.013|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.081|0.056|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.056|-0.081|
71860778|NCT03670277|143236358|OTHER|Statistically significance of difference. Statistical difference will be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|0.031|STANDARD_ERROR_OF_MEAN|0.035|||TWO_SIDED|95.0|-0.037|0.1|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|This was a pilot study for assessing the investigational test articles. As such, the sample size was not determined based on any power analysis with regard to the primary endpoint.||0.100|-0.037|
71860779|NCT03670277|143236359|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.403|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|2.557|4.248|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At -30°||4.248|2.557|
71860780|NCT03670277|143236359|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|2.431|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|95.0|1.585|3.277|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - Control|At +30°||3.277|1.585|
71860781|NCT03670277|143236360|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|3.039|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|1.854|4.225|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At -30°||4.225|1.854|
71860782|NCT03670277|143236360|OTHER|Statistically significance of difference. Statistical difference would be concluded if the lower limit was greater than 0 or the upper limit was less than 0.|Least Square Mean Difference|1.414|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|95.0|0.228|2.599|||Mixed Models Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test - Control|At +30°||2.599|0.228|
71860783|NCT02660112|143236361|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
71688706|NCT03749109|142892869|OTHER||Difference in LS mean|-1.13||||0.92|TWO_SIDED|95.0|-22.77|20.51|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||20.51|-22.77|0.92
71860784|NCT02104505|143236377|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.18||0.04|TWO_SIDED||||||Mixed Models Analysis||Comparison of change in sputum %PMNs during active treatment vs placebo (crossover design).|||||0.04
71860785|NCT02104505|143236378|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71860786|NCT02104505|143236379|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.6|TWO_SIDED||||||Mixed Models Analysis|||||||0.6
71860787|NCT02104505|143236380|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.33||0.34|TWO_SIDED||||||Mixed Models Analysis|||||||0.34
71860788|NCT03382561|143236414|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.17|TWO_SIDED|95.0|0.55|1.11|||Log Rank||Hazard ratio: Arm A (CEN)/Arm B (CE)|||1.11|0.55|0.17
71860789|NCT01150045|143236453|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.12|TWO_SIDED|95.0|0.76|1.03|||Log Rank|||||1.03|0.76|0.12
71860790|NCT02431052|143236456|OTHER|||||||0.0006|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0006
71860791|NCT02431052|143236457|OTHER|||||||0.0002|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.||||||0.0002
71860792|NCT02431052|143236458|OTHER|||||||0.0055|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).||||||0.0055
71860793|NCT02094898|143236459|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860794|NCT02094898|143236459|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
71860795|NCT02094898|143236460|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
71860796|NCT02094898|143236461|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860797|NCT02094898|143236461|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860798|NCT02094898|143236461|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
71860799|NCT02094898|143236462|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
71860800|NCT02094898|143236463|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860801|NCT02094898|143236463|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
71907277|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.17|STANDARD_ERROR_OF_MEAN|4.37|<|0.001|TWO_SIDED|95.0|-73.78|-56.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.56|-73.78|<0.001
71907278|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-64.76|STANDARD_ERROR_OF_MEAN|3.84|<|0.001|TWO_SIDED|95.0|-72.32|-57.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.19|-72.32|<0.001
71907279|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.25|STANDARD_ERROR_OF_MEAN|4.28|<|0.001|TWO_SIDED|95.0|-46.68|-29.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.81|-46.68|<0.001
71907280|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.52|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-45.15|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.90|-45.15|<0.001
71907281|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.61|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-64.73|-54.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.48|-64.73|<0.001
71907282|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.2|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-64.8|-53.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.60|-64.80|<0.001
71907283|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.27|STANDARD_ERROR_OF_MEAN|3.2|<|0.001|TWO_SIDED|95.0|-64.6|-51.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.94|-64.60|<0.001
71907284|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.31|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-64.29|-50.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.32|-64.29|<0.001
71907285|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.06|STANDARD_ERROR_OF_MEAN|2.59|<|0.001|TWO_SIDED|95.0|-65.18|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.18|<0.001
71681477|NCT00501059|142881370|OTHER||Cox Proportional Hazard|1.1||||0.4796|TWO_SIDED|95.0|0.84|1.45|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.||1.45|0.84|0.4796
71907286|NCT01763866|143336953|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-62.82|STANDARD_ERROR_OF_MEAN|3.75|<|0.001|TWO_SIDED|95.0|-70.22|-55.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-55.42|-70.22|<0.001
71907287|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.84|<|0.001|TWO_SIDED|95.0|-67.25|-56.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-56.03|-67.25|<0.001
71907288|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.93|STANDARD_ERROR_OF_MEAN|3.28|<|0.001|TWO_SIDED|95.0|-61.4|-48.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.46|-61.40|<0.001
71681478|NCT02719938|142881376|SUPERIORITY|||||||0.415|||||||t-test, 2 sided|||||||0.415
71681479|NCT02719938|142881377|SUPERIORITY|||||||0.521|||||||t-test, 2 sided|||||||0.521
71860802|NCT02094898|143236464|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860803|NCT02094898|143236465|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860804|NCT02094898|143236465|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860805|NCT02094898|143236466|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860806|NCT02094898|143236467|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
71860807|NCT02094898|143236467|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
71860808|NCT02094898|143236468|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
71860809|NCT02094898|143236469|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.05
71860810|NCT02094898|143236469|SUPERIORITY||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.08
71907289|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.11|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-40.79|-29.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.44|-40.79|<0.001
71907290|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.72|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-44.15|-31.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.30|-44.15|<0.001
71860811|NCT02094898|143236470|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.001
71860812|NCT02094898|143236471|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860813|NCT02094898|143236471|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.||||<0.01
71860814|NCT03520075|143236483|SUPERIORITY||Geometric Least Squares Mean (Geo LSM)|27.8|||||TWO_SIDED|90.0|8.5|91.2|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||91.2|8.50|
71860815|NCT03520075|143236483|SUPERIORITY||Geo LSM|38.8|||||TWO_SIDED|90.0|11.4|132.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||132|11.4|
71860816|NCT03520075|143236483|SUPERIORITY||Geo LSM|58.9|||||TWO_SIDED|90.0|15.7|222.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||222|15.7|
71860817|NCT03520075|143236483|SUPERIORITY||Geo LSM|47.2|||||TWO_SIDED|90.0|20.7|108.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-24 between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||108|20.7|
71860818|NCT03520075|143236484|SUPERIORITY||Geo LSM|18.1|||||TWO_SIDED|90.0|5.28|61.9|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||61.9|5.28|
71860819|NCT03520075|143236484|SUPERIORITY||Geo LSM|44.1|||||TWO_SIDED|90.0|8.32|234.0|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||234|8.32|
71907291|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.64|STANDARD_ERROR_OF_MEAN|4.69|<|0.001|TWO_SIDED|95.0|-75.88|-57.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-57.39|-75.88|<0.001
71860820|NCT03520075|143236484|SUPERIORITY||Geo LSM|58.7|||||TWO_SIDED|90.0|15.7|220.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||220|15.7|
71860821|NCT03520075|143236484|SUPERIORITY||Geo LSM|40.2|||||TWO_SIDED|90.0|14.3|113.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on AUC0-inf between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||113|14.3|
71860822|NCT03520075|143236485|SUPERIORITY||Geo LSM|17.5|||||TWO_SIDED|90.0|5.62|54.3|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||54.3|5.62|
71860823|NCT03520075|143236485|SUPERIORITY||Geo LSM|34.5|||||TWO_SIDED|90.0|12.0|99.4|||||Ratio of Geo LSM was calculated for Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||99.4|12.0|
71860824|NCT03520075|143236485|SUPERIORITY||Geo LSM|72.6|||||TWO_SIDED|90.0|17.6|299.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||299|17.6|
71860825|NCT03520075|143236485|SUPERIORITY||Geo LSM|72.5|||||TWO_SIDED|90.0|29.1|181.0|||||Ratio of Geo LSM was calculated for Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029.|Comparison of effect of food on Cmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||181|29.1|
71681480|NCT02719938|142881378|SUPERIORITY|||||||0.409|||||||t-test, 2 sided|||||||0.409
71681481|NCT02719938|142881379|SUPERIORITY|||||||0.019|||||||Chi-squared|||||||0.019
71860826|NCT03520075|143236486|SUPERIORITY||Hodges-Lehmann Estimator|-2.275||||0.0388671|TWO_SIDED|90.0|-5.216|-0.083|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% confidence interval (CI) was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C1D1.||-0.0830|-5.2160|0.0388671
71860827|NCT03520075|143236486|SUPERIORITY||Hodges-Lehmann Estimator|1.45||||0.4795001|TWO_SIDED|90.0|-0.917|5.15|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 6 (fed state) and Cohort 9 (fasted state) treatment arm groups of 80 mg ASTX029 in C2D1.||5.1500|-0.9170|0.4795001
71860828|NCT03520075|143236486|SUPERIORITY||Hodges-Lehmann Estimator|-0.45||||0.8272593|TWO_SIDED|90.0|-2.467|0.95|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C1D1.||0.9500|-2.4670|0.8272593
71860829|NCT03520075|143236486|SUPERIORITY||Hodges-Lehmann Estimator|0.583||||0.5126908|TWO_SIDED|90.0|-6.45|3.5|||Wilcoxon (Mann-Whitney)||The Hodges-Lehmann estimator and 90% CI was calculated using the Moses approximation.|Comparison of effect of food on Tmax between Cohort 7 (fed state) and Cohort 10 (fasted state) treatment arm groups of 120 mg ASTX029 in C2D1.||3.5000|-6.4500|0.5126908
71907292|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.01|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-68.49|-51.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.52|-68.49|<0.001
71907293|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.51|STANDARD_ERROR_OF_MEAN|4.59|<|0.001|TWO_SIDED|95.0|-49.55|-31.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.47|-49.55|<0.001
71860830|NCT01234883|143236507|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71860831|NCT01375751|143236544|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.82|STANDARD_ERROR_OF_MEAN|3.92|<|0.001|TWO_SIDED|95.0|-51.56|-36.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference.|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-36.09|-51.56|<0.001
71907294|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.79|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-41.3|-24.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.28|-41.30|<0.001
71907295|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.96|STANDARD_ERROR_OF_MEAN|2.95|<|0.001|TWO_SIDED|95.0|-65.78|-54.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.13|-65.78|<0.001
71681482|NCT02719938|142881380|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71681483|NCT02719938|142881381|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71860832|NCT01375751|143236544|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.36|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-64.06|-48.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.||-48.67|-64.06|<0.001
71860833|NCT01375751|143236545|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-65.5|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-79.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-51.4|-79.6|<0.001
71860834|NCT01375751|143236545|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-84.7|STANDARD_ERROR_OF_MEAN|7.1|<|0.001|TWO_SIDED|95.0|-98.8|-70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-70.7|-98.8|<0.001
71681484|NCT02719938|142881382|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
71681485|NCT00955968|142881383|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.54|TWO_SIDED|95.0|0.19|2.4||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.40|0.19|0.54
71681486|NCT00955968|142881384|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.66|TWO_SIDED|95.0|0.11|4.01||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||4.01|0.11|0.66
71681487|NCT00955968|142881386|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.44|TWO_SIDED|95.0|0.09|2.81||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||2.81|0.09|0.44
71681488|NCT00955968|142881387|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.79|TWO_SIDED|95.0|0.54|1.6||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.60|0.54|0.79
71907296|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.42|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-63.27|-51.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.57|-63.27|<0.001
71907297|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.58|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-66.95|-52.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.21|-66.95|<0.001
71907298|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.76|STANDARD_ERROR_OF_MEAN|4.3|<|0.001|TWO_SIDED|95.0|-58.26|-41.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.27|-58.26|<0.001
71907299|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.91|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-66.57|-55.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.24|-66.57|<0.001
71907300|NCT01763866|143336954|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.63|STANDARD_ERROR_OF_MEAN|4.06|<|0.001|TWO_SIDED|95.0|-64.63|-48.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-48.62|-64.63|<0.001
71907301|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.49|STANDARD_ERROR_OF_MEAN|2.34|<|0.001|TWO_SIDED|95.0|-63.1|-53.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.89|-63.10|<0.001
71907302|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.25|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-57.49|-47.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-47.01|-57.49|<0.001
71907303|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.66|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-38.33|-28.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.98|-38.33|<0.001
71907304|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.01|STANDARD_ERROR_OF_MEAN|2.67|<|0.001|TWO_SIDED|95.0|-45.27|-34.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.74|-45.27|<0.001
71907305|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.34|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-66.61|-52.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.07|-66.61|<0.001
71907306|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.74|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-65.56|-51.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.93|-65.56|<0.001
71907307|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-42.09|-27.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-27.75|-42.09|<0.001
71681489|NCT00955968|142881388|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.71|TWO_SIDED|95.0|0.54|1.52||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||1.52|0.54|0.71
71860835|NCT01375751|143236546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.79|STANDARD_ERROR_OF_MEAN|3.81|<|0.001|TWO_SIDED|95.0|-49.32|-34.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-34.26|-49.32|<0.001
71860836|NCT01375751|143236546|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.46|STANDARD_ERROR_OF_MEAN|3.79|<|0.001|TWO_SIDED|95.0|-60.95|-45.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-45.97|-60.95|<0.001
71860837|NCT01375751|143236547|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|3.55|<|0.001|TWO_SIDED|95.0|-41.77|-27.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.74|-41.77|<0.001
71907308|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.64|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-46.57|-32.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.71|-46.57|<0.001
71907309|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.86|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-59.66|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.05|-59.66|<0.001
71907310|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.14|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-60.66|-51.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.61|-60.66|<0.001
71907311|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.78|STANDARD_ERROR_OF_MEAN|3.01|<|0.001|TWO_SIDED|95.0|-56.72|-44.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.83|-56.72|<0.001
71922049|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-3.2|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 10, pre-dose AM||13.4|-3.2|
71860838|NCT01375751|143236547|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.2|STANDARD_ERROR_OF_MEAN|3.53|<|0.001|TWO_SIDED|95.0|-53.18|-39.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-39.23|-53.18|<0.001
71922050|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-1.5|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-11.0|8.0|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.0|-11.0|
71922051|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.9|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-10.3|8.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 11, pre-dose AM||8.6|-10.3|
71681490|NCT00955968|142881389|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.42|0.8||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART|||0.80|0.42|<0.001
71922052|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|2.9|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-7.7|13.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||13.4|-7.7|
71922053|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.2|STANDARD_ERROR_OF_MEAN|5.1|||TWO_SIDED|95.0|-9.4|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 12, pre-dose AM||11.8|-9.4|
71922054|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.0|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.4|10.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||10.3|-8.4|
71922055|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.1|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.3|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose AM||9.4|-9.3|
71922056|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|7.0|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-1.3|15.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||15.3|-1.3|
71922057|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|9.9|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|1.6|18.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 1 hour||18.2|1.6|
71922058|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|5.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-1.0|12.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||12.3|-1.0|
71922059|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|7.2|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|0.5|13.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, post-dose AM 4 hour||13.9|0.5|
71907312|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.94|STANDARD_ERROR_OF_MEAN|3.12|<|0.001|TWO_SIDED|95.0|-61.11|-48.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.76|-61.11|<0.001
71907313|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.34|STANDARD_ERROR_OF_MEAN|2.33|<|0.001|TWO_SIDED|95.0|-59.94|-50.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.74|-59.94|<0.001
71907314|NCT01763866|143336955|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.87|STANDARD_ERROR_OF_MEAN|3.24|<|0.001|TWO_SIDED|95.0|-63.27|-50.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.46|-63.27|<0.001
71907315|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-58.79|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-64.03|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.55|-64.03|<0.001
71907316|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.36|STANDARD_ERROR_OF_MEAN|2.96|<|0.001|TWO_SIDED|95.0|-53.2|-41.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.52|-53.20|<0.001
71907317|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.92|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-40.23|-29.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.60|-40.23|<0.001
71907318|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.21|STANDARD_ERROR_OF_MEAN|2.97|<|0.001|TWO_SIDED|95.0|-42.06|-30.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.35|-42.06|<0.001
71907319|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-69.27|-53.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-53.54|-69.27|<0.001
71907320|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.01|STANDARD_ERROR_OF_MEAN|3.93|<|0.001|TWO_SIDED|95.0|-60.77|-45.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-45.25|-60.77|<0.001
71907321|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.45|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-45.17|-29.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.74|-45.17|<0.001
71907322|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.31|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-42.15|-26.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.47|-42.15|<0.001
71907323|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|-61.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.40|-61.60|<0.001
71907324|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.21|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-58.29|-48.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.13|-58.29|<0.001
71907325|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.52|STANDARD_ERROR_OF_MEAN|3.31|<|0.001|TWO_SIDED|95.0|-57.06|-43.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-43.99|-57.06|<0.001
71907326|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.95|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-54.43|-39.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.47|-54.43|<0.001
71860839|NCT01375751|143236548|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.66|STANDARD_ERROR_OF_MEAN|3.72|<|0.001|TWO_SIDED|95.0|-44.01|-29.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placbo is the reference|||-29.32|-44.01|<0.001
71860840|NCT01375751|143236548|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.01|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-52.32|-37.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.70|-52.32|<0.001
71860841|NCT01375751|143236549|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.92|STANDARD_ERROR_OF_MEAN|3.45|<|0.001|TWO_SIDED|95.0|-40.72|-27.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-27.11|-40.72|<0.001
71860842|NCT01375751|143236549|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.64|STANDARD_ERROR_OF_MEAN|3.43|<|0.001|TWO_SIDED|95.0|-51.41|-37.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|||-37.86|-51.41|<0.001
71860843|NCT02980523|143236550|NON_INFERIORITY_OR_EQUIVALENCE|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.002|||||||Chi-squared|||||||0.002
71907327|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.3|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-61.47|-51.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-51.14|-61.47|<0.001
71907328|NCT01763866|143336956|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.73|STANDARD_ERROR_OF_MEAN|3.38|<|0.001|TWO_SIDED|95.0|-59.4|-46.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-46.06|-59.40|<0.001
71907329|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.41|STANDARD_ERROR_OF_MEAN|2.16|<|0.001|TWO_SIDED|95.0|-50.66|-42.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.15|-50.66|<0.001
71907330|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.69|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-49.75|-39.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.63|-49.75|<0.001
71860844|NCT02980523|143236551|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.372|||||||Chi-squared, Corrected|||||||0.372
71860845|NCT02980523|143236552|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.341|||||||Chi-squared, Corrected|||||||0.341
71907331|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.06|STANDARD_ERROR_OF_MEAN|2.19|<|0.001|TWO_SIDED|95.0|-30.36|-21.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.75|-30.36|<0.001
71907332|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.59|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-36.61|-26.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.57|-36.61|<0.001
71860846|NCT02980523|143236553|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.001|||||||Chi-squared, Corrected|||||||0.001
71860847|NCT02980523|143236554|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.003|||||||Chi-squared, Corrected|||||||0.003
71860848|NCT02980523|143236555|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.216|||||||Chi-squared, Corrected|||||||0.216
71860849|NCT02980523|143236556|NON_INFERIORITY|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.829|||||||Chi-squared, Corrected|||||||0.829
71860850|NCT01271504|143236580|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.5||||||||1.50|0.56|
71860851|NCT01271504|143236581|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.57|1.5||||||||1.50|0.57|
71860852|NCT01271504|143236583|SUPERIORITY||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.6|1.62||||||||1.62|0.60|
71860853|NCT02229227|143236592|NON_INFERIORITY|If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17||Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.|t-test, 2 sided||Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.|||0.17|-0.05|<0.0001
71907333|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.48|STANDARD_ERROR_OF_MEAN|3.15|<|0.001|TWO_SIDED|95.0|-50.69|-38.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.27|-50.69|<0.001
71907334|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.85|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-52.48|-41.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.21|-52.48|<0.001
71907335|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.001|TWO_SIDED|95.0|-34.39|-22.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.21|-34.39|<0.001
71860854|NCT02229227|143236594|OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.31|0.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||0.60|0.31|<0.0001
71860855|NCT02229227|143236595|SUPERIORITY||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-3.82|-4.93|<0.0001
71860856|NCT02229227|143236596|OTHER||Mean Difference (Net)|-1.21|||||TWO_SIDED|95.0|-1.43|-1.0|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.|Week 4||-1.00|-1.43|
71860857|NCT02229227|143236596|OTHER||Mean Difference (Net)|-1.8|||||TWO_SIDED|95.0|-2.05|-1.55|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.|Week 5||-1.55|-2.05|
71860858|NCT02229227|143236596|OTHER||Mean Difference (Net)|-3.17|||||TWO_SIDED|95.0|-3.51|-2.82|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.|Week 10||-2.82|-3.51|
71860859|NCT02229227|143236596|OTHER||Mean Difference (Net)|-4.01|||||TWO_SIDED|95.0|-4.48|-3.54|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.|Week 18||-3.54|-4.48|
71860860|NCT02229227|143236596|OTHER||Mean Difference (Net)|-4.37|||<|0.0001|TWO_SIDED|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.|Week 26||-3.82|-4.93|<0.0001
71860861|NCT02229227|143236597|SUPERIORITY||Mean Difference (Final Values)|-60.83|||<|0.0001|TWO_SIDED|95.0|-66.57|-55.1|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-55.10|-66.57|<0.0001
71860862|NCT02229227|143236598|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.12|||<|0.0001|TWO_SIDED|95.0|-0.18|-0.07|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.07|-0.18|<0.0001
71860863|NCT02229227|143236598|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.15|-0.02|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||-0.02|-0.15|<0.0001
71860864|NCT02229227|143236598|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.08|||<|0.0001|TWO_SIDED|95.0|-0.01|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.17|-0.01|<0.0001
71907336|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.18|STANDARD_ERROR_OF_MEAN|2.88|<|0.001|TWO_SIDED|95.0|-33.86|-22.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-22.50|-33.86|<0.001
71907337|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.73|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-49.5|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.97|-49.50|<0.001
71907338|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.01|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-52.46|-41.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.57|-52.46|<0.001
71907339|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.59|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-45.38|-35.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.79|-45.38|<0.001
71907340|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.33|STANDARD_ERROR_OF_MEAN|2.87|<|0.001|TWO_SIDED|95.0|-46.0|-34.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.66|-46.00|<0.001
71907341|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.05|STANDARD_ERROR_OF_MEAN|2.38|<|0.001|TWO_SIDED|95.0|-51.76|-42.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.35|-51.76|<0.001
71907342|NCT01763866|143336957|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.62|STANDARD_ERROR_OF_MEAN|2.86|<|0.001|TWO_SIDED|95.0|-54.27|-42.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-42.98|-54.27|<0.001
71907343|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-46.83|STANDARD_ERROR_OF_MEAN|2.48|<|0.001|TWO_SIDED|95.0|-51.73|-41.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-41.94|-51.73|<0.001
71907344|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.86|STANDARD_ERROR_OF_MEAN|2.82|<|0.001|TWO_SIDED|95.0|-48.43|-37.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.30|-48.43|<0.001
71907345|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.6|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-33.56|-23.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.65|-33.56|<0.001
71907346|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.22|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-35.74|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.70|-35.74|<0.001
71860865|NCT02229227|143236598|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.11|||<|0.0001|TWO_SIDED|95.0|0.01|0.21|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||0.21|0.01|<0.0001
71860866|NCT02229227|143236598|NON_INFERIORITY|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.06|||<|0.0001|TWO_SIDED|95.0|-0.05|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||0.17|-0.05|<0.0001
71907347|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.1|STANDARD_ERROR_OF_MEAN|3.33|<|0.001|TWO_SIDED|95.0|-51.66|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-38.54|-51.66|<0.001
71907348|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.43|STANDARD_ERROR_OF_MEAN|3.34|<|0.001|TWO_SIDED|95.0|-49.01|-35.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.85|-49.01|<0.001
71907349|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-30.26|STANDARD_ERROR_OF_MEAN|3.26|<|0.001|TWO_SIDED|95.0|-36.68|-23.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.84|-36.68|<0.001
71907350|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.19|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|-31.79|-18.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.59|-31.79|<0.001
71907351|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.25|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-48.77|-37.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-37.74|-48.77|<0.001
71907352|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.33|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-51.04|-39.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-39.61|-51.04|<0.001
71907353|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.13|STANDARD_ERROR_OF_MEAN|2.79|<|0.001|TWO_SIDED|95.0|-46.65|-35.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-35.61|-46.65|<0.001
71907354|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.99|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-41.72|-28.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.25|-41.72|<0.001
71907355|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.04|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-51.83|-42.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.25|-51.83|<0.001
71860867|NCT02229227|143236599|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||-0.25|-0.86|0.0004
71860868|NCT02229227|143236600|OTHER||Mean Difference (Net)|-0.54|||||TWO_SIDED|95.0|-0.84|-0.24|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-0.24|-0.84|
71860869|NCT02229227|143236600|OTHER||Mean Difference (Net)|-0.19|||||TWO_SIDED|95.0|-0.51|0.13|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||0.13|-0.51|
71860870|NCT02229227|143236600|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-0.85|-0.22|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-0.22|-0.85|
71860871|NCT02229227|143236600|SUPERIORITY||Mean Difference (Net)|-0.55||||0.0004|TWO_SIDED|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||-0.25|-0.86|0.0004
71860872|NCT02229227|143236601|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.31|0.71|0.7026
71860873|NCT02229227|143236602|OTHER||Odds Ratio (OR)|1.17||||0.2883|TWO_SIDED|95.0|0.84|1.64||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4|Week 4||1.64|0.84|0.2883
71860874|NCT02229227|143236602|OTHER||Odds Ratio (OR)|0.82||||0.3034|TWO_SIDED|95.0|0.59|1.15||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.15|0.59|0.3034
71860875|NCT02229227|143236602|OTHER||Odds Ratio (OR)|0.71||||0.0151|TWO_SIDED|95.0|0.52|0.98||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||0.98|0.52|0.0151
71860876|NCT02229227|143236602|OTHER||Odds Ratio (OR)|0.75||||0.0518|TWO_SIDED|95.0|0.54|1.03||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.03|0.54|0.0518
71860877|NCT02229227|143236602|OTHER||Odds Ratio (OR)|0.96||||0.7026|TWO_SIDED|95.0|0.71|1.31||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.31|0.71|0.7026
71907356|NCT01763866|143336958|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.6|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-50.67|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-38.54|-50.67|<0.001
71907357|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.97|STANDARD_ERROR_OF_MEAN|2.51|<|0.001|TWO_SIDED|95.0|-64.91|-55.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.03|-64.91|<0.001
71907358|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.11|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-59.57|-48.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.64|-59.57|<0.001
71922060|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.5|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-8.4|7.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||7.4|-8.4|
71922061|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|1.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-6.0|9.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 13, pre-dose PM||9.9|-6.0|
71681491|NCT00955968|142881390|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1|TWO_SIDED|95.0|0.72|1.03||5% alpha level and 2-sided test|Log Rank|||||1.03|0.72|0.10
71907359|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.54|<|0.001|TWO_SIDED|95.0|-42.8|-32.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.77|-42.80|<0.001
71860878|NCT02229227|143236603|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||1.17|0.63|0.2298
71860879|NCT02229227|143236604|OTHER||Odds Ratio (OR)|1.32||||0.2143|TWO_SIDED|95.0|0.78|2.23||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||2.23|0.78|0.2143
71860880|NCT02229227|143236604|OTHER||Odds Ratio (OR)|1.24||||0.4703|TWO_SIDED|95.0|0.8|1.91||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5||1.91|0.80|0.4703
71860881|NCT02229227|143236604|OTHER||Odds Ratio (OR)|0.81||||0.2139|TWO_SIDED|95.0|0.58|1.14||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||1.14|0.58|0.2139
71860882|NCT02229227|143236604|OTHER||Odds Ratio (OR)|0.81||||0.079|TWO_SIDED|95.0|0.59|1.11||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||1.11|0.59|0.0790
71860883|NCT02229227|143236604|OTHER||Odds Ratio (OR)|0.85||||0.2298|TWO_SIDED|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||1.17|0.63|0.2298
71860884|NCT02229227|143236605|OTHER||Odds Ratio (OR)|1.08||||0.8292|TWO_SIDED|95.0|0.24|4.77||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.77|0.24|0.8292
71860885|NCT02229227|143236607|OTHER||Mean Difference (Final Values)|-56.38|||||TWO_SIDED|95.0|-59.19|-53.57|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.57|-59.19|
71860886|NCT02229227|143236607|OTHER||Mean Difference (Final Values)|-63.7|||||TWO_SIDED|95.0|-67.78|-59.62|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-59.62|-67.78|
71860887|NCT02229227|143236607|OTHER||Mean Difference (Final Values)|-62.0|||||TWO_SIDED|95.0|-67.29|-56.7|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-56.70|-67.29|
71860888|NCT02229227|143236608|SUPERIORITY||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-2.25|0.3|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||0.30|-2.25|
71907360|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.86|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-47.34|-36.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.67|-47.34|<0.001
71907361|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.9|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|95.0|-64.22|-49.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.59|-64.22|<0.001
71907362|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.99|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-68.68|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-55.29|-68.68|<0.001
71907363|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.26|STANDARD_ERROR_OF_MEAN|3.66|<|0.001|TWO_SIDED|95.0|-44.48|-30.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.04|-44.48|<0.001
71860889|NCT02229227|143236608|OTHER||Mean Difference (Final Values)|0.34|||||TWO_SIDED|95.0|-1.64|2.33|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||2.33|-1.64|
71907364|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.29|STANDARD_ERROR_OF_MEAN|3.44|<|0.001|TWO_SIDED|95.0|-50.07|-36.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-36.51|-50.07|<0.001
71907365|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.29|STANDARD_ERROR_OF_MEAN|2.78|<|0.001|TWO_SIDED|95.0|-60.79|-49.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.79|-60.79|<0.001
71907366|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-59.24|STANDARD_ERROR_OF_MEAN|2.49|<|0.001|TWO_SIDED|95.0|-64.16|-54.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.32|-64.16|<0.001
71907367|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.63|STANDARD_ERROR_OF_MEAN|3.13|<|0.001|TWO_SIDED|95.0|-56.82|-44.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-44.45|-56.82|<0.001
71907368|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.78|STANDARD_ERROR_OF_MEAN|3.61|<|0.001|TWO_SIDED|95.0|-63.91|-49.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.64|-63.91|<0.001
71681492|NCT03559868|142881412|SUPERIORITY||||||<|0.01|||||||ANOVA|Ordinary one-way ANOVA Bartlett's test||For IL10||||<0.01
71860890|NCT02229227|143236608|OTHER||Mean Difference (Final Values)|0.24|||||TWO_SIDED|95.0|-2.21|2.69|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||2.69|-2.21|
71860891|NCT02229227|143236608|OTHER||Mean Difference (Final Values)|0.39||||0.7699|TWO_SIDED|95.0|-2.25|3.04|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26||3.04|-2.25|0.7699
71907369|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.75|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-62.51|-52.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.99|-62.51|<0.001
71907370|NCT01763866|143336959|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.06|STANDARD_ERROR_OF_MEAN|2.93|<|0.001|TWO_SIDED|95.0|-61.85|-50.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-50.27|-61.85|<0.001
71907371|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.29|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED|95.0|-65.65|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-54.94|-65.65|<0.001
71907372|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.44|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-54.23|-42.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.65|-54.23|<0.001
71907373|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.66|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-45.09|-34.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-34.23|-45.09|<0.001
71907374|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.32|STANDARD_ERROR_OF_MEAN|2.94|<|0.001|TWO_SIDED|95.0|-43.12|-31.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-31.52|-43.12|<0.001
71907375|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.77|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|95.0|-65.55|-49.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.99|-65.55|<0.001
71681493|NCT01785849|142881433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|32.46|||<|0.001|TWO_SIDED|95.0|18.71|56.31|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (\< 600, ≥ 600 to ≤ 1000, and \> 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with \> 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.||56.31|18.71|<0.001
71860892|NCT02229227|143236609|OTHER||Mean Difference (Final Values)|-56.05|||||TWO_SIDED|95.0|-58.17|-53.94|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4||-53.94|-58.17|
71907376|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.26|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-64.91|-49.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-49.60|-64.91|<0.001
71681494|NCT01785849|142881434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.08|||<|0.001|TWO_SIDED|95.0|11.47|42.48|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by screening PTH category, recent cinacalcet use within 8 weeks before randomization, and region.||||42.48|11.47|<0.001
71681495|NCT01785849|142881435|SUPERIORITY_OR_OTHER||Mean Difference|-71.11|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|-77.77|-64.46|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-64.46|-77.77|<0.001
71681496|NCT01785849|142881436|SUPERIORITY_OR_OTHER||Mean Difference|-8.38|STANDARD_ERROR_OF_MEAN|0.58|<|0.001|TWO_SIDED|95.0|-9.52|-7.23|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-7.23|-9.52|<0.001
71681497|NCT01785849|142881437|SUPERIORITY_OR_OTHER||Mean Difference|-14.99|STANDARD_ERROR_OF_MEAN|2.41|<|0.001|TWO_SIDED|95.0|-19.73|-10.25|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-10.25|-19.73|<0.001
71860893|NCT02229227|143236609|OTHER||Mean Difference (Final Values)|-64.76|||||TWO_SIDED|95.0|-67.68|-61.85|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10||-61.85|-67.68|
71860894|NCT02229227|143236609|OTHER||Mean Difference (Final Values)|-62.92|||||TWO_SIDED|95.0|-66.69|-59.15|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18||-59.15|-66.69|
71860895|NCT02229227|143236609|SUPERIORITY||Mean Difference (Final Values)|-61.83|||<|0.0001|TWO_SIDED|95.0|-65.85|-57.81|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|week 26||-57.81|-65.85|<0.0001
71860896|NCT02229227|143236611|OTHER||Odds Ratio (OR)|3.5|||<|0.0001|TWO_SIDED|95.0|2.52|4.86||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||4.86|2.52|<0.0001
71907377|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.9|STANDARD_ERROR_OF_MEAN|3.87|<|0.001|TWO_SIDED|95.0|-47.53|-32.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-32.26|-47.53|<0.001
71907378|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.57|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-46.26|-30.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-30.88|-46.26|<0.001
71907379|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.41|STANDARD_ERROR_OF_MEAN|2.83|<|0.001|TWO_SIDED|95.0|-59.99|-48.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-48.82|-59.99|<0.001
71907380|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.13|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-61.58|-50.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-50.68|-61.58|<0.001
71907381|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.17|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|-55.8|-42.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-42.53|-55.80|<0.001
71907382|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|4.25|<|0.001|TWO_SIDED|95.0|-57.21|-40.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-40.40|-57.21|<0.001
71681498|NCT01785849|142881438|SUPERIORITY_OR_OTHER||Mean Difference|-7.45|STANDARD_ERROR_OF_MEAN|2.47||0.003|TWO_SIDED|95.0|-12.31|-2.59|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo|||-2.59|-12.31|0.003
71681499|NCT01254851|142881448|SUPERIORITY_OR_OTHER||Standardized test statistic (z-score)|0.39||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.70
71681500|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-3.3|3.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 1||3.0|-3.3|< 0.001
71860897|NCT02229227|143236612|OTHER||Odds Ratio (OR)|2.36|||<|0.0001|TWO_SIDED|95.0|1.54|3.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||3.60|1.54|<0.0001
71860898|NCT02229227|143236613|OTHER||Odds Ratio (OR)|3.78|||<|0.0001|TWO_SIDED|95.0|2.21|6.48||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.|||6.48|2.21|<0.0001
71860899|NCT05186311|143236633|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit (CAL).||||||||||||||||One hundred (100) participants (with paired numerical data) per each analyte provide \> 90% power to ensure that mean biases and confidence intervals are within the clinical acceptance limit (CAL), at medically relevant points, assuming no true bias between the tube types, residual standard deviation (SD) or coefficient of variation (CV) = CAL and collected data cover medically relevant points.|"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860900|NCT05186311|143236634|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71882473|NCT01087905|143284055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.003|TWO_SIDED|95.0|1.2|2.45|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."||2.45|1.20|.003
71907383|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-62.82|-52.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-52.65|-62.82|<0.001
71907384|NCT01763866|143336960|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.04|STANDARD_ERROR_OF_MEAN|3.07|<|0.001|TWO_SIDED|95.0|-58.1|-45.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-45.98|-58.10|<0.001
71907385|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|82.4|||<|0.001|TWO_SIDED|95.0|70.2|88.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.5|70.2|<0.001
71907386|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.3|||<|0.001|TWO_SIDED|95.0|67.9|86.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||86.8|67.9|<0.001
71907387|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.1|||<|0.001|TWO_SIDED|95.0|53.1|78.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||78.1|53.1|<0.001
71907388|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|69.2|||<|0.001|TWO_SIDED|95.0|54.8|78.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||78.5|54.8|<0.001
71907389|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.7|||<|0.001|TWO_SIDED|95.0|67.3|88.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.3|67.3|<0.001
71907390|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.3|||<|0.001|TWO_SIDED|95.0|70.7|89.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.6|70.7|<0.001
71907391|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|43.5|||<|0.001|TWO_SIDED|95.0|29.5|56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||56.7|29.5|<0.001
71860901|NCT05186311|143236635|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860902|NCT05186311|143236636|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860903|NCT05186311|143236637|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860904|NCT05186311|143236638|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860905|NCT05186311|143236639|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71882474|NCT01087905|143284056|SUPERIORITY_OR_OTHER||incremental cost-effectiveness ratio|357.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.||||
71907392|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|30.3|||<|0.001|TWO_SIDED|95.0|16.7|44.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||44.2|16.7|<0.001
71907393|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.7|||<|0.001|TWO_SIDED|95.0|69.5|88.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||88.0|69.5|<0.001
71688707|NCT03749109|142892869|OTHER||Difference in LS mean|-5.92||||0.74|TWO_SIDED|95.0|-40.94|29.1|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||29.10|-40.94|0.74
71681501|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|24.2|||<|0.001|TWO_SIDED|95.0|18.7|30.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar|Type 3||30.0|18.7|< 0.001
71688708|NCT03749109|142892870|OTHER||Odds Ratio (OR)|1.04||||0.95|TWO_SIDED|95.0|0.38|2.82|||Regression, Logistic|||Endometrioma||2.82|0.38|0.95
71860906|NCT05186311|143236640|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860907|NCT05186311|143236641|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71688709|NCT03749109|142892870|OTHER||Odds Ratio (OR)|0.55||||0.39|TWO_SIDED|95.0|0.14|2.17|||Regression, Logistic|||Adenomyosis||2.17|0.14|0.39
71907394|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|73.1|90.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.2|73.1|<0.001
71681502|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|3.0|||<|0.001|TWO_SIDED|95.0|0.0|6.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 4||6.4|0.0|< 0.001
71688710|NCT03749109|142892871|OTHER||Odds Ratio (OR)|0.7||||0.6|TWO_SIDED|95.0|0.19|2.65|||Regression, Logistic|||Endometrioma||2.65|0.19|0.60
71860908|NCT05186311|143236642|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860909|NCT05186311|143236643|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860910|NCT05186311|143236644|EQUIVALENCE|The estimated regression equation was then used to estimate the bias (with two one-sided 95% confidence intervals, referred to as 95% limits in the text) between the evaluation tube and the comparator tube at all prespecified medical decision levels. The biases and 95% limit were compared to the clinical acceptance limit|||||||||||||||||"No p-value were established. Rather a bias between tube types at pre-determined medical decision points were estimated with 95% intervals. The mean biases and 95% limit were compared to the CAL. For equivalence testing the initial alpha level is set at 10%. This corresponds to obtaining 90% confidence intervals (associated with 95% two 1-sided confidence limits). Since the clinical equivalence includes two comparisons, the actual alpha used for each comparison was set to 5%, using a Bonferroni correction. No other adjustment for multiplicity will be made on any other comparisons.~Note that for the confidence intervals (CI) calculated for the intercept and slope of the regression parameters, no multiplicity adjustments on the a level are performed (alpha = 0.05)."|||
71860911|NCT03178344|143236675|EQUIVALENCE|ANOVA||||||0.7||||||P value threshold is 0.05|ANOVA|||||||0.70
71860912|NCT03178344|143236676|EQUIVALENCE|ANOVA||||||0.71||||||P value threshold is 0.05.|ANOVA|||||||0.71
71860913|NCT04560374|143236700|EQUIVALENCE|Power analysis was performed after the completion of the study. 98% power was obtained.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71860914|NCT02489734|143236725|SUPERIORITY||Relative risk (RR)|3.4||||0.003|TWO_SIDED|95.0|1.4|8.1|||Chi-squared|||||8.1|1.4|0.003
71860915|NCT03721172|143236726|SUPERIORITY||Adjusted difference|17.5|||<|0.0001|TWO_SIDED|95.0|12.2|22.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||22.8|12.2|<0.0001
71860916|NCT03721172|143236727|SUPERIORITY||Adjusted difference|25.6|||<|0.0001|TWO_SIDED|95.0|19.1|32.1|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.1|19.1|<0.0001
71860917|NCT03721172|143236728|SUPERIORITY||Least squares mean difference|-3.38|STANDARD_ERROR_OF_MEAN|0.33|<|0.0001|TWO_SIDED|95.0|-4.04|-2.73|||Mixed-effect model for repeated measures|||||-2.73|-4.04|<0.0001
71860918|NCT03721172|143236729|SUPERIORITY||Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.47|-2.39|||Mixed-effect model for repeated measures|||||-2.39|-3.47|<0.0001
71860919|NCT03721172|143236730|SUPERIORITY||Adjusted difference|38.0|||<|0.0001|TWO_SIDED|95.0|29.7|46.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||46.3|29.7|<0.0001
71860920|NCT03721172|143236731|SUPERIORITY||Adjusted difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.5|32.8|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||32.8|16.5|<0.0001
71860921|NCT03721172|143236732|SUPERIORITY||Adjusted difference|27.4|||<|0.0001|TWO_SIDED|95.0|18.6|36.3|||Cochran-Mantel-Haenszel|Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|2-sided 95% CIs based on the stratified Newcombe method. Stratification were based on baseline sPGA (2 \[mild\] vs 3 \[moderate\]).|||36.3|18.6|<0.0001
71860922|NCT03721172|143236733|SUPERIORITY||Least squares mean difference|-2.9|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-3.7|-2.1|||Mixed-effect model for repeated measures|||||-2.1|-3.7|<0.0001
71860923|NCT00420784|143236735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.23|||<|0.001|TWO_SIDED|95.0|4.14|16.36|||Regression, Logistic|||||16.36|4.14|<0.001
71860924|NCT00420784|143236735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.52|||<|0.001|TWO_SIDED|95.0|4.72|19.2|||Regression, Logistic|||||19.20|4.72|<0.001
71860925|NCT00420784|143236735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.31||||0.024|TWO_SIDED|95.0|1.12|4.75|||Regression, Logistic|||||4.75|1.12|0.024
71860926|NCT00420784|143236737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.64|||<|0.001|TWO_SIDED|95.0|3.41|12.96|||Regression, Logistic|||||12.96|3.41|<0.001
71860927|NCT00420784|143236737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.72|||<|0.001|TWO_SIDED|95.0|2.91|11.27|||Regression, Logistic|||||11.27|2.91|<0.001
71860928|NCT00420784|143236737|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.95||||0.067|TWO_SIDED|95.0|0.95|4.0|||Regression, Logistic|||||4.00|0.95|0.067
71860929|NCT03603639|143236752|SUPERIORITY||LS Mean difference|1.38|||||TWO_SIDED|90.0|-0.72|3.48||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.48|-0.72|
71907395|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|54.6|||<|0.001|TWO_SIDED|95.0|39.8|66.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||66.9|39.8|<0.001
71907396|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.7|||<|0.001|TWO_SIDED|95.0|51.0|76.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||76.6|51.0|<0.001
71907397|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|91.7|||<|0.001|TWO_SIDED|95.0|81.6|95.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.3|81.6|<0.001
71907398|NCT01763866|143336961|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|84.6|||<|0.001|TWO_SIDED|95.0|72.8|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||90.0|72.8|<0.001
71907399|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|83.5|||<|0.001|TWO_SIDED|95.0|71.9|89.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||89.2|71.9|<0.001
71860930|NCT03603639|143236752|SUPERIORITY||LS Mean difference|1.07|||||TWO_SIDED|90.0|-0.49|2.63||||||The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.63|-0.49|
71860931|NCT03603639|143236753|SUPERIORITY||LS Mean Difference|0.39|||||TWO_SIDED|90.0|-0.75|1.54||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.54|-0.75|
71907400|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.3|||<|0.001|TWO_SIDED|95.0|65.2|85.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.3|65.2|<0.001
71860932|NCT03603639|143236753|SUPERIORITY||LS Mean Difference|0.3|||||TWO_SIDED|90.0|-0.6|1.21||||||In eye closure condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||1.21|-0.60|
71860933|NCT03603639|143236753|SUPERIORITY||LS Mean Difference|1.62|||||TWO_SIDED|90.0|-1.16|4.39||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||4.39|-1.16|
71860934|NCT03603639|143236753|SUPERIORITY||LS Mean Difference|1.05|||||TWO_SIDED|90.0|-0.89|2.98||||||In eyes closed condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.98|-0.89|
71860935|NCT03603639|143236753|SUPERIORITY||LS Mean Difference|0.21|||||TWO_SIDED|90.0|-1.87|2.28||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||2.28|-1.87|
71860936|NCT03603639|143236753|SUPERIORITY||LS Mean Difference|1.27|||||TWO_SIDED|90.0|-0.57|3.11||||||In eyes open condition. The mixed effects model for the crossover part of the study will include treatment, period, and sequence as fixed effects, baseline (Predose) measurement as a covariate, and subject nested within sequence as a random effect.||3.11|-0.57|
71860937|NCT02402322|143236783|NON_INFERIORITY_OR_EQUIVALENCE|In the preliminary analysis, we studied the possible group differences in demographic data and pretreatment measures with chi-square tests and analysis of variance (ANOVA).||||||0.05|TWO_SIDED||||||ANOVA|||The participants' pre- and posttreatment scores were studied with repeated measures ANOVA. Within- and between-group effect sizes were calculated using the pooled standard deviation, Cohen's d.||||0.05
71860938|NCT02472145|143236794|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4747|TWO_SIDED|95.0|0.8|2.8|||Chi-squared|||Statistical Analysis 1||2.8|0.8|0.4747
71860939|NCT02472145|143236795|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7817|TWO_SIDED|95.0|0.79|1.37|||Log Rank|||Statistical Analysis 1||1.37|0.79|0.7817
71907401|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|47.3|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||73.9|47.3|<0.001
71860940|NCT00409409|143236836|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||||||0.0010
71860941|NCT00820664|143236837|SUPERIORITY_OR_OTHER||Least Squares Mean|0.49|||<|0.001||95.0|0.31|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.31|<0.001
71860942|NCT00820664|143236837|SUPERIORITY_OR_OTHER||Least Squares Mean|0.19||||0.032||95.0|0.02|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.||||1.00|0.02|0.032
71860943|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|1.1||||0.9998|TWO_SIDED|95.0|0.2|4.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||4.9|0.2|0.9998
71860944|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9345|TWO_SIDED|95.0|0.3|7.5|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.5|0.3|0.9345
71860945|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|0.5||||0.5836|TWO_SIDED|95.0|0.1|2.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||2.1|0.1|0.5836
71860946|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|2.4||||0.4844|TWO_SIDED|95.0|0.5|10.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||10.6|0.5|0.4844
71860947|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|1.4||||0.9725|TWO_SIDED|95.0|0.3|6.8|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||6.8|0.3|0.9725
71860948|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|0.4||||0.4715|TWO_SIDED|95.0|0.1|1.9|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.9|0.1|0.4715
71860949|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|2.2||||0.5969|TWO_SIDED|95.0|0.5|9.6|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||9.6|0.5|0.5969
71860950|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|0.3||||0.2043|TWO_SIDED|95.0|0.1|1.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||1.4|0.1|0.2043
71860951|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|1.5||||0.9388|TWO_SIDED|95.0|0.3|7.4|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||7.4|0.3|0.9388
71860952|NCT03635086|143236839|OTHER||Geometric Mean Ratio Estimate|5.2||||0.0251|TWO_SIDED|95.0|1.2|23.1|||Tukey-Kramer|||GMT ratios were estimated by applying an analysis of variance (ANOVA) including the factor treatment group. This was done using log10 transformed data and taking the anti-log of the resulting point estimates for the least squares means, least squares means differences and the corresponding 2-sided 95% confidence intervals (CI). P-values were also provided to compare GMTs between treatment groups adjusted for multiple comparisons according to Tukey-Kramer.||23.1|1.2|0.0251
71860953|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.6||||0.5263|TWO_SIDED|95.0|0.2|1.6|||ANOVA|||Day 0||1.6|0.2|0.5263
71907402|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.9|||<|0.001|TWO_SIDED|95.0|49.8|75.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||75.2|49.8|<0.001
71907403|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|80.1|||<|0.001|TWO_SIDED|95.0|65.8|87.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.9|65.8|<0.001
71860954|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
71907404|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.2|||<|0.001|TWO_SIDED|95.0|67.9|88.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)||||88.1|67.9|<0.001
71907405|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|41.1|||<|0.001|TWO_SIDED|95.0|26.4|55.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||55.1|26.4|<0.001
71907406|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|35.2|||<|0.001|TWO_SIDED|95.0|20.7|49.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||49.3|20.7|<0.001
71907407|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|77.3|||<|0.001|TWO_SIDED|95.0|63.9|84.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||84.7|63.9|<0.001
71907408|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|81.1|||<|0.001|TWO_SIDED|95.0|68.8|87.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||87.5|68.8|<0.001
71860955|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
71860956|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
71860957|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.55|TWO_SIDED|95.0|0.6|4.7|||ANOVA|||Day 0||4.7|0.6|0.5500
71860958|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
71860959|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.5263|TWO_SIDED|95.0|0.6|4.6|||ANOVA|||Day 0||4.6|0.6|0.5263
71860960|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
71860961|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.8|||ANOVA|||Day 0||2.8|0.4|1.0000
71860962|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.4|2.7|||ANOVA|||Day 0||2.7|0.4|1.0000
71860963|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5321|TWO_SIDED|95.0|0.2|1.7|||ANOVA|||Day 28||1.7|0.2|0.5321
71860964|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9983|TWO_SIDED|95.0|0.3|3.9|||ANOVA|||Day 28||3.9|0.3|0.9983
71860965|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8234|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 28||2.1|0.2|0.8234
71688711|NCT03749109|142892871|OTHER||Odds Ratio (OR)|0.35||||0.21|TWO_SIDED|95.0|0.07|1.79|||Regression, Logistic|||Adenomyosis||1.79|0.07|0.21
71860966|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9882|TWO_SIDED|95.0|0.2|2.7|||ANOVA|||Day 28||2.7|0.2|0.9882
71860967|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.3778|TWO_SIDED|95.0|0.6|7.6|||ANOVA|||Day 28||7.6|0.6|0.3778
71860968|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9878|TWO_SIDED|95.0|0.4|4.1|||ANOVA|||Day 28||4.1|0.4|0.9878
71860969|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.8213|TWO_SIDED|95.0|0.5|5.3|||ANOVA|||Day 28||5.3|0.5|0.8213
71860970|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.6716|TWO_SIDED|95.0|0.2|1.9|||ANOVA|||Day 28||1.9|0.2|0.6716
71860971|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.938|TWO_SIDED|95.0|0.2|2.5|||ANOVA|||Day 28||2.5|0.2|0.9380
71860972|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9777|TWO_SIDED|95.0|0.4|4.3|||ANOVA|||Day 28||4.3|0.4|0.9777
71860973|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9997|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 56||4.7|0.3|0.9997
71860974|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9287|TWO_SIDED|95.0|0.3|7.2|||ANOVA|||Day 56||7.2|0.3|0.9287
71907409|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|52.7|||<|0.001|TWO_SIDED|95.0|37.6|65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||65.3|37.6|<0.001
71907410|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.3|||<|0.001|TWO_SIDED|95.0|49.1|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||75.5|49.1|<0.001
71907411|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|92.5|||<|0.001|TWO_SIDED|95.0|82.3|95.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||95.9|82.3|<0.001
71907412|NCT01763866|143336962|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|78.4|||<|0.001|TWO_SIDED|95.0|64.9|85.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).||||85.4|64.9|<0.001
71907413|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.08|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-39.06|-25.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.11|-39.06|<0.001
71860975|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.5598|TWO_SIDED|95.0|0.1|2.0|||ANOVA|||Day 56||2.0|0.1|0.5598
71860976|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|3.0||||0.2117|TWO_SIDED|95.0|0.7|13.1|||ANOVA|||Day 56||13.1|0.7|0.2117
71860977|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9699|TWO_SIDED|95.0|0.3|6.6|||ANOVA|||Day 56||6.6|0.3|0.9699
71860978|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.4||||0.446|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.4460
71860979|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.8||||0.292|TWO_SIDED|95.0|0.6|11.9|||ANOVA|||Day 56||11.9|0.6|0.2920
71907414|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.86|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-29.7|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.03|-29.70|<0.001
71907415|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.45|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|-34.53|-20.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.38|-34.53|<0.001
71922062|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|3.9|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.0|11.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.8|-4.0|
71922063|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|3.8|||TWO_SIDED|95.0|-4.6|11.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, pre-dose AM||11.2|-4.6|
71860980|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.184|TWO_SIDED|95.0|0.1|1.4|||ANOVA|||Day 56||1.4|0.1|0.1840
71860981|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7229|TWO_SIDED|95.0|0.4|9.2|||ANOVA|||Day 56||9.2|0.4|0.7229
71860982|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|6.6||||0.0052|TWO_SIDED|95.0|1.5|28.6|||ANOVA|||Day 56||28.6|1.5|0.0052
71860983|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9777|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 182||3.0|0.2|0.9777
71860984|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9812|TWO_SIDED|95.0|0.3|5.3|||ANOVA|||Day 182||5.3|0.3|0.9812
71860985|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9979|TWO_SIDED|95.0|0.3|4.5|||ANOVA|||Day 182||4.5|0.3|0.9979
71860986|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.588|TWO_SIDED|95.0|0.5|7.9|||ANOVA|||Day 182||7.9|0.5|0.5880
71860987|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7973|TWO_SIDED|95.0|0.4|7.0|||ANOVA|||Day 182||7.0|0.4|0.7973
71860988|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.8992|TWO_SIDED|95.0|0.4|6.0|||ANOVA|||Day 182||6.0|0.4|0.8992
71860989|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.7||||0.2602|TWO_SIDED|95.0|0.7|10.4|||ANOVA|||Day 182||10.4|0.7|0.2602
71860990|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.9991|TWO_SIDED|95.0|0.2|3.6|||ANOVA|||Day 182||3.6|0.2|0.9991
71860991|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9028|TWO_SIDED|95.0|0.4|6.2|||ANOVA|||Day 182||6.2|0.4|0.9028
71860992|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7761|TWO_SIDED|95.0|0.4|6.8|||ANOVA|||Day 182||6.8|0.4|0.7761
71860993|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.7833|TWO_SIDED|95.0|0.2|2.1|||ANOVA|||Day 365||2.1|0.2|0.7833
71860994|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9915|TWO_SIDED|95.0|0.2|2.9|||ANOVA|||Day 365||2.9|0.2|0.9915
71860995|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.9||||0.998|TWO_SIDED|95.0|0.3|3.0|||ANOVA|||Day 365||3.0|0.3|0.9980
71860996|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.909|TWO_SIDED|95.0|0.4|4.9|||ANOVA|||Day 365||4.9|0.4|0.9090
71860997|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9651|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9651
71860998|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9112|TWO_SIDED|95.0|0.4|4.7|||ANOVA|||Day 365||4.7|0.4|0.9112
71860999|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.4||||0.257|TWO_SIDED|95.0|0.7|7.8|||ANOVA|||Day 365||7.8|0.7|0.2570
71861000|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|3.8|||ANOVA|||Day 365||3.8|0.3|0.9999
71907416|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.49|STANDARD_ERROR_OF_MEAN|3.99|<|0.001|TWO_SIDED|95.0|-37.36|-21.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.62|-37.36|<0.001
71907417|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.52|STANDARD_ERROR_OF_MEAN|3.65|<|0.001|TWO_SIDED|95.0|-27.71|-13.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.33|-27.71|<0.001
71861001|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.8||||0.6953|TWO_SIDED|95.0|0.5|6.2|||ANOVA|||Day 365||6.2|0.5|0.6953
71861002|NCT03635086|143236842|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.7523|TWO_SIDED|95.0|0.5|5.4|||ANOVA|||Day 365||5.4|0.5|0.7523
71861003|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups|Geometric Mean Ratio Estimate|0.5||||0.5263|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 0||1.7|0.1|0.5263
71861004|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
71861005|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
71907418|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.96|STANDARD_ERROR_OF_MEAN|4.08|<|0.001|TWO_SIDED|95.0|-37.01|-20.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-20.92|-37.01|<0.001
71922064|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.3|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-8.0|7.3|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||7.3|-8.0|
71861006|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
71861007|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.55|TWO_SIDED|95.0|0.6|7.0|||ANOVA|||Day 0||7.0|0.6|0.5500
71861008|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
71861009|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.5263|TWO_SIDED|95.0|0.6|6.7|||ANOVA|||Day 0||6.7|0.6|0.5263
71861010|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
71861011|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.5|||ANOVA|||Day 0||3.5|0.3|1.0000
71861012|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.3|3.4|||ANOVA|||Day 0||3.4|0.3|1.0000
71861013|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7708|TWO_SIDED|95.0|0.1|2.4|||ANOVA|||Day 28||2.4|0.1|0.7708
71861014|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.2||||0.9966|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9966
71861015|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9503|TWO_SIDED|95.0|0.2|3.0|||ANOVA|||Day 28||3.0|0.2|0.9503
71861016|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.7||||0.9791|TWO_SIDED|95.0|0.2|3.2|||ANOVA|||Day 28||3.2|0.2|0.9791
71861017|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.2||||0.5739|TWO_SIDED|95.0|0.5|9.8|||ANOVA|||Day 28||9.8|0.5|0.5739
71861018|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9918|TWO_SIDED|95.0|0.3|5.4|||ANOVA|||Day 28||5.4|0.3|0.9918
71861019|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.4||||0.9748|TWO_SIDED|95.0|0.3|5.9|||ANOVA|||Day 28||5.9|0.3|0.9748
71861020|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.827|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 28||2.6|0.1|0.8270
71861021|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.893|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 28||2.8|0.1|0.8930
71861022|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.1||||0.9999|TWO_SIDED|95.0|0.3|4.7|||ANOVA|||Day 28||4.7|0.3|0.9999
71861023|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9105|TWO_SIDED|95.0|0.1|3.2|||ANOVA|||Day 56||3.2|0.1|0.9105
71861024|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.5|||ANOVA|||Day 56||5.5|0.2|1.0000
71861025|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3047|TWO_SIDED|95.0|0.1|1.7|||ANOVA|||Day 56||1.7|0.1|0.3047
71861026|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment.|Geometric Mean Ratio Estimate|5.5||||0.0423|TWO_SIDED|95.0|1.0|29.2|||ANOVA|||Day 56||29.2|1.0|0.0423
71861027|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9213|TWO_SIDED|95.0|0.3|9.1|||ANOVA|||Day 56||9.1|0.3|0.9213
71861028|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.8092|TWO_SIDED|95.0|0.1|2.8|||ANOVA|||Day 56||2.8|0.1|0.8092
71861029|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|9.1||||0.004|TWO_SIDED|95.0|1.7|48.5|||ANOVA|||Day 56||48.5|1.7|0.0040
71861030|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.3||||0.3347|TWO_SIDED|95.0|0.1|1.8|||ANOVA|||Day 56||1.8|0.1|0.3347
71861031|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|5.6||||0.0488|TWO_SIDED|95.0|1.0|30.7|||ANOVA|||Day 56||30.7|1.0|0.0488
71861032|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|17.4||||0.0001|TWO_SIDED|95.0|3.3|92.2|||ANOVA|||Day 56||92.2|3.3|0.0001
71861033|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8831|TWO_SIDED|95.0|0.1|3.0|||ANOVA|||Day 182||3.0|0.1|0.8831
71861034|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
71861035|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.8916|TWO_SIDED|95.0|0.1|3.1|||ANOVA|||Day 182||3.1|0.1|0.8916
71861036|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.9||||0.794|TWO_SIDED|95.0|0.4|9.9|||ANOVA|||Day 182||9.9|0.4|0.7940
71861037|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.6||||0.9169|TWO_SIDED|95.0|0.3|8.9|||ANOVA|||Day 182||8.9|0.3|0.9169
71861038|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.0||||1|TWO_SIDED|95.0|0.2|5.2|||ANOVA|||Day 182||5.2|0.2|1.0000
71861039|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2563|TWO_SIDED|95.0|0.6|17.1|||ANOVA|||Day 182||17.1|0.6|0.2563
71861040|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.9237|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 182||3.3|0.1|0.9237
71861041|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7708|TWO_SIDED|95.0|0.4|10.8|||ANOVA|||Day 182||10.8|0.4|0.7708
71688712|NCT03749109|142892872|OTHER||Rate Ratio|2.53||||0.13|TWO_SIDED|95.0|0.76|8.39|||Negative-binomial regression|||Endometrioma - Disappearing Lesions||8.39|0.76|0.13
71861042|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|3.3||||0.2661|TWO_SIDED|95.0|0.6|16.9|||ANOVA|||Day 182||16.9|0.6|0.2661
71861043|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.5||||0.7614|TWO_SIDED|95.0|0.1|2.6|||ANOVA|||Day 365||2.6|0.1|0.7614
71861044|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9905|TWO_SIDED|95.0|0.1|4.3|||ANOVA|||Day 365||4.3|0.1|0.9905
71861045|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.6||||0.933|TWO_SIDED|95.0|0.1|3.3|||ANOVA|||Day 365||3.3|0.1|0.9330
71861046|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9945|TWO_SIDED|95.0|0.2|6.7|||ANOVA|||Day 365||6.7|0.2|0.9945
71861047|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.5||||0.9599|TWO_SIDED|95.0|0.3|8.4|||ANOVA|||Day 365||8.4|0.3|0.9599
71861048|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.3||||0.9942|TWO_SIDED|95.0|0.2|6.4|||ANOVA|||Day 365||6.4|0.2|0.9942
71861049|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.5||||0.4932|TWO_SIDED|95.0|0.5|12.9|||ANOVA|||Day 365||12.9|0.5|0.4932
71861050|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|0.8||||0.9983|TWO_SIDED|95.0|0.2|4.6|||ANOVA|||Day 365||4.6|0.2|0.9983
71907419|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.02|STANDARD_ERROR_OF_MEAN|3.6|<|0.001|TWO_SIDED|95.0|-39.11|-24.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.93|-39.11|<0.001
71861051|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|1.7||||0.9112|TWO_SIDED|95.0|0.3|9.3|||ANOVA|||Day 365||9.3|0.3|0.9112
71861052|NCT03635086|143236851|OTHER|Analysis of variance (ANOVA) for GMT of Chikungunya-ELISA antibodies between treatment groups.|Geometric Mean Ratio Estimate|2.0||||0.7431|TWO_SIDED|95.0|0.4|10.2|||ANOVA|||Day 365||10.2|0.4|0.7431
71861053|NCT00513747|143236857|SUPERIORITY|||||||0.1521|||||||Log Rank|||||||0.1521
71861054|NCT00513747|143236858|SUPERIORITY|||||||0.0097|||||||Log Rank|||||||0.0097
71861055|NCT00513747|143236859|SUPERIORITY|||||||0.4645|||||||Log Rank|||||||0.4645
71861056|NCT01056263|143236866|SUPERIORITY_OR_OTHER||Five year survival probability|20.6|||||TWO_SIDED|95.0|10.94|32.38||||||Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.||32.38|10.94|
71861057|NCT01262092|143236867|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2887||||0.035||95.0||||p values \<0.05 considered statistically significant|Mixed Models Analysis|Used proc GLIMMIX to model group by time (6 study visits)||"test null hypothesis that gbp and pla did not differ in terms of opioid-positive urines during the buprenorphine detox.~For the analysis, data from 2 participants in the GBP groups were excluded due to evidence of medication diversion (N=1) and not being maintained on the 1600 mg/day dose of GBP (N=1)."||||0.035
71861058|NCT04147858|143236868|SUPERIORITY|||||||0.539|||||||t-test, 2 sided|||||||0.539
71861059|NCT04147858|143236868|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
71861060|NCT04147858|143236869|SUPERIORITY|||||||0.824|||||||t-test, 2 sided|||||||0.824
71861061|NCT04147858|143236869|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71861062|NCT04147858|143236870|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
71861063|NCT04147858|143236870|SUPERIORITY|||||||0.603|||||||t-test, 2 sided|||||||0.603
71861064|NCT04147858|143236871|SUPERIORITY|||||||0.871|||||||t-test, 2 sided|||||||0.871
71861065|NCT04147858|143236871|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
71861066|NCT04147858|143236872|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1.000
71861067|NCT04147858|143236872|SUPERIORITY|||||||0.626|||||||t-test, 2 sided|||||||0.626
71861068|NCT04147858|143236873|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||||||0.059
71861069|NCT04147858|143236873|SUPERIORITY|||||||0.726|||||||t-test, 2 sided|||||||0.726
71861070|NCT04147858|143236874|SUPERIORITY|||||||0.888|||||||t-test, 2 sided|||||||0.888
71861071|NCT04147858|143236874|SUPERIORITY|||||||0.832|||||||t-test, 2 sided|||||||0.832
71861072|NCT04147858|143236875|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||||||0.536
71861073|NCT04147858|143236875|SUPERIORITY|||||||0.982|||||||t-test, 2 sided|||||||0.982
71861074|NCT04147858|143236876|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|||||||0.190
71861075|NCT04147858|143236876|SUPERIORITY|||||||0.764|||||||t-test, 2 sided|||||||0.764
71861076|NCT04147858|143236877|SUPERIORITY|||||||0.097|||||||t-test, 2 sided|||||||0.097
71861077|NCT04147858|143236877|SUPERIORITY|||||||0.849|||||||t-test, 2 sided|||||||0.849
71907420|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.42|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-45.61|-29.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.23|-45.61|<0.001
71907421|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.66|STANDARD_ERROR_OF_MEAN|3.69|<|0.001|TWO_SIDED|95.0|-42.94|-28.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.38|-42.94|<0.001
71861078|NCT03771638|143236878|SUPERIORITY|Minimum detectable effects: Under assumptions of the adherence of DBS TFV-DP levels \>=700 fmol/punch in the control condition as 60% and intraclass correlation of repeated binary measures of DBS TFV-DP of 0.69, and retention of 80% of participants at 24 weeks, we will have 80% power in 2-sided tests with a type-1 error rate of 5% to detect average between-group differences in adherence of 23 percentage points.|Risk Ratio (RR)|1.01||||0.94|TWO_SIDED|95.0|0.75|1.36||GEE poisson models with robust standard errors were used to assess DBS adherence rates, averaged across visits.|GEE Poisson models|||Null hypothesis: no difference in PrEP adherence levels between DOT Diary Intervention and Control arms||1.36|0.75|0.94
71861079|NCT03771638|143236879|OTHER||Kappa statistic|0.49|||||TWO_SIDED|95.0|0.36|0.62|||Kappa|||Kappa statistic to assess concordance between DBS measurement and self-reported PrEP use||0.62|0.36|
71907422|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.81|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-35.36|-18.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-18.27|-35.36|<0.001
71861080|NCT04750577|143236889|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0245|||||||MCP-Mod exponential model fit|Model assumption: 20% of the maximum effect is achieved at 3 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0245
71861081|NCT04750577|143236889|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0294|||||||MCP-Mod linear model fit|Model assumption: No assumption was needed.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0294
71861082|NCT04750577|143236889|OTHER|A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||||0.0468||||||MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.|MCP-Mod quadratic model fit|Model assumption: 50 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||||||0.0468
71861083|NCT04750577|143236889|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0586|||||||MCP-Mod Emax model fit|Model assumption: 80% of the maximum effect is achieved at 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0586
71861084|NCT04750577|143236889|OTHER|MMRM estimates were used as input for the MCP-Mod. including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit as well as random effects of patient.||||||0.0659|||||||MCP-Mod Sigmoid emax model fit|Model assumption: 30 % of the maximum effect is achieved at a dose of 3 mg. 90 % of the maximum effect is achieved at a dose of 6 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 685509 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, quadratic, Emax and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.050). The total daily dose was considered for MCP-Mod analysis (placebo, active BI 685509 3 mg, 6 mg, and 9 mg).||||0.0659
71861085|NCT04750577|143236889|OTHER||Mean Difference (Net)|-0.103||||0.3224|TWO_SIDED|95.0|-0.309|0.102|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean ofPlacebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.102|-0.309|0.3224
71907423|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.56|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-40.74|-26.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.37|-40.74|<0.001
71907424|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.19|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-40.8|-23.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-23.58|-40.80|<0.001
71907425|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.07|STANDARD_ERROR_OF_MEAN|3.46|<|0.001|TWO_SIDED|95.0|-34.91|-21.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.23|-34.91|<0.001
71861086|NCT04750577|143236889|OTHER||Mean Difference (Net)|-0.063||||0.5616|TWO_SIDED|95.0|-0.275|0.15|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.150|-0.275|0.5616
71861087|NCT04750577|143236889|OTHER||Mean Difference (Net)|-0.251||||0.0183|TWO_SIDED|95.0|-0.459|-0.043|||Mixed-effect Model Repeat Measurement||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.043|-0.459|0.0183
71861088|NCT04750577|143236890|OTHER||Mean Difference (Net)|-0.211||||0.0396|TWO_SIDED|0.95|-0.413|-0.01|||Mixed Models Analysis||"Least Squares Mean of 1 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.010|-0.413|0.0396
71861089|NCT04750577|143236890|OTHER||Mean Difference (Net)|-0.12||||0.2568|TWO_SIDED|0.95|-0.327|0.088|||Mixed Models Analysis||"Least Squares Mean of 2 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||0.088|-0.327|0.2568
71861090|NCT04750577|143236890|OTHER||Mean Difference (Net)|-0.357||||0.0006|TWO_SIDED|0.95|-0.56|-0.154|||Mixed Models Analysis||"Least Squares Mean of 3 mg BI 685509 TID- Least Squares Mean of Placebo"|Least Square Means difference and 95% confidence interval were estimated by restricted maximum likelihood based Mixed-effect Model for Repeated Measures ((REML)-based MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12 and Week 20) as well as random effects of patient.||-0.154|-0.560|0.0006
71907426|NCT01763866|143336963|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.16|STANDARD_ERROR_OF_MEAN|3.76|<|0.001|TWO_SIDED|95.0|-34.59|-19.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.73|-34.59|<0.001
71907427|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.001|TWO_SIDED|95.0|-40.81|-25.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-25.60|-40.81|<0.001
71861091|NCT04750577|143236891|OTHER||Odds Ratio (OR)|2.25||||0.0519|TWO_SIDED|95.0|0.99|5.1|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||5.10|0.99|0.0519
71907428|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.82|STANDARD_ERROR_OF_MEAN|4.11|<|0.001|TWO_SIDED|95.0|-27.92|-11.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.72|-27.92|<0.001
71907429|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.16|STANDARD_ERROR_OF_MEAN|3.91|<|0.001|TWO_SIDED|95.0|-36.87|-21.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.44|-36.87|<0.001
71861092|NCT04750577|143236891|OTHER||Odds Ratio (OR)|1.43||||0.4159|TWO_SIDED|95.0|0.61|3.36|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.36|0.61|0.4159
71861093|NCT04750577|143236891|OTHER||Odds Ratio (OR)|2.9||||0.0106|TWO_SIDED|95.0|1.28|6.55|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.55|1.28|0.0106
71907430|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.44|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-35.56|-19.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.32|-35.56|<0.001
71907431|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.38|STANDARD_ERROR_OF_MEAN|4.07|<|0.001|TWO_SIDED|95.0|-30.39|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.36|-30.39|<0.001
71907432|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.1|STANDARD_ERROR_OF_MEAN|4.32|<|0.001|TWO_SIDED|95.0|-36.62|-19.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-19.58|-36.62|<0.001
71907433|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.62|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-40.46|-24.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.78|-40.46|<0.001
71907434|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.88|STANDARD_ERROR_OF_MEAN|4.38|<|0.001|TWO_SIDED|95.0|-43.52|-26.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-26.25|-43.52|<0.001
71907435|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.5|STANDARD_ERROR_OF_MEAN|4.15|<|0.001|TWO_SIDED|95.0|-44.69|-28.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-28.30|-44.69|<0.001
71907436|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.34|STANDARD_ERROR_OF_MEAN|4.48|<|0.001|TWO_SIDED|95.0|-34.19|-16.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.49|-34.19|<0.001
71907437|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.48|STANDARD_ERROR_OF_MEAN|3.78|<|0.001|TWO_SIDED|95.0|-43.95|-29.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-29.02|-43.95|<0.001
71907438|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.17|STANDARD_ERROR_OF_MEAN|5.28|<|0.001|TWO_SIDED|95.0|-42.61|-21.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-21.74|-42.61|<0.001
71907439|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.25|STANDARD_ERROR_OF_MEAN|3.62|<|0.001|TWO_SIDED|95.0|-38.4|-24.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-24.10|-38.40|<0.001
71907440|NCT01763866|143336964|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.17|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-36.79|-19.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-19.55|-36.79|<0.001
71907441|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.1|STANDARD_ERROR_OF_MEAN|4.83||0.2|TWO_SIDED|95.0|-21.63|-2.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.58|-21.63|0.20
71907442|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.55|STANDARD_ERROR_OF_MEAN|5.36||0.003|TWO_SIDED|95.0|-33.13|-11.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.97|-33.13|0.003
71907443|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.45|STANDARD_ERROR_OF_MEAN|4.89||1|TWO_SIDED|95.0|-12.09|7.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.19|-12.09|1.00
71681503|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.5|||<|0.001|TWO_SIDED|95.0|-3.9|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 5||2.8|-3.9|< 0.001
71907444|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.95|STANDARD_ERROR_OF_MEAN|5.33||0.053|TWO_SIDED|95.0|-25.46|-4.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.44|-25.46|0.053
71907445|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.43|STANDARD_ERROR_OF_MEAN|4.89||0.073|TWO_SIDED|95.0|-25.06|-5.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.79|-25.06|0.073
71688713|NCT03749109|142892872|OTHER||Rate Ratio|0.49||||0.56|TWO_SIDED|95.0|0.04|5.41|||Negative-binomial regression|||Adenomyosis - Disappearing Lesions||5.41|0.04|0.56
71861094|NCT04750577|143236892|OTHER||Odds Ratio (OR)|2.79||||0.0176|TWO_SIDED|95.0|1.2|6.53|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||6.53|1.20|0.0176
71861095|NCT04750577|143236892|OTHER||Odds Ratio (OR)|1.32||||0.5467|TWO_SIDED|95.0|0.53|3.29|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||3.29|0.53|0.5467
71861096|NCT04750577|143236892|OTHER||Odds Ratio (OR)|4.46||||0.0005|TWO_SIDED|95.0|1.91|10.39|||Regression, Logistic||Odds Ratio was calculated as BI 685509/ Placebo.|Treatment, sodium-Glucose co-Transporter-2 Inhibitor (SGLT2i) use at baseline, and type of diabetes were used as covariates in the logistic regression model.||10.39|1.91|0.0005
71861097|NCT01310699|143236919|SUPERIORITY|||||||0.21|||||||Chi-squared|||||||0.21
71861098|NCT01310699|143236920|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
71861099|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.99|||||TWO_SIDED|95.0|0.65|1.52||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.52|0.65|
71861100|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|2.11|||||TWO_SIDED|95.0|1.5|2.98||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.98|1.5|
71861101|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.68|||||TWO_SIDED|95.0|0.43|1.06||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.06|0.43|
71861102|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.71|||||TWO_SIDED|95.0|0.58|0.87||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.87|0.58|
71907446|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.41|STANDARD_ERROR_OF_MEAN|5.32||0.027|TWO_SIDED|95.0|-24.9|-3.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.92|-24.90|0.027
71861103|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.0|||||TWO_SIDED|95.0|0.92|1.08||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.08|0.92|
71861104|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.78|||||TWO_SIDED|95.0|0.6|1.01||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||1.01|0.6|
71861105|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.27|||||TWO_SIDED|95.0|0.83|1.96||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.96|0.83|
71861106|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|1.6|||||TWO_SIDED|95.0|1.13|2.28||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.28|1.13|
71861107|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.52|||||TWO_SIDED|95.0|0.33|0.81||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||0.81|0.33|
71861108|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.52|0.78||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.78|0.52|
71861109|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.96|||||TWO_SIDED|95.0|0.89|1.04||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.04|0.89|
71861110|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||TWO_SIDED|95.0|0.49|0.84||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.84|0.49|
71861111|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.02|||||TWO_SIDED|95.0|0.66|1.58||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1||1.58|0.66|
71688714|NCT03749109|142892873|OTHER||Difference in LS mean|0.23||||0.97|TWO_SIDED|95.0|-12.78|13.23|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||13.23|-12.78|0.97
71861112|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|1.62|||||TWO_SIDED|95.0|1.14|2.3||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50||2.3|1.14|
71907447|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.17|STANDARD_ERROR_OF_MEAN|4.8||1|TWO_SIDED|95.0|-10.63|8.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.30|-10.63|1.00
71907448|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.51|STANDARD_ERROR_OF_MEAN|5.38||0.63|TWO_SIDED|95.0|-12.12|9.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.11|-12.12|0.63
71907449|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.72|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-32.9|-12.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.54|-32.90|<0.001
71907450|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.52|STANDARD_ERROR_OF_MEAN|5.69||0.007|TWO_SIDED|95.0|-30.76|-8.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.28|-30.76|0.007
71861113|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.74|||||TWO_SIDED|95.0|0.47|1.17||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1||1.17|0.47|
71861114|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.46|||||TWO_SIDED|95.0|0.38|0.57||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50||0.57|0.38|
71861115|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.94|||||TWO_SIDED|95.0|0.87|1.02||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1||1.02|0.87|
71907451|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-17.59|STANDARD_ERROR_OF_MEAN|4.62||0.002|TWO_SIDED|95.0|-26.71|-8.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.46|-26.71|0.002
71907452|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.18|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-35.76|-16.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-16.59|-35.76|<0.001
71907453|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.97|STANDARD_ERROR_OF_MEAN|5.78|<|0.001|TWO_SIDED|95.0|-32.38|-9.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.55|-32.38|<0.001
71907454|NCT01763866|143336965|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.71|STANDARD_ERROR_OF_MEAN|5.64|<|0.001|TWO_SIDED|95.0|-40.84|-18.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.57|-40.84|<0.001
71861116|NCT02035696|143236927|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.57|||||TWO_SIDED|95.0|0.44|0.75||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50||0.75|0.44|
71861117|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|10.0|||||TWO_SIDED|95.0|0.0|18.9||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||18.9|0|
71861118|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|2.0|||||TWO_SIDED|95.0|-4.0|8.0||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||8|-4|
71861119|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-11.0|||||TWO_SIDED|95.0|-21.1|-1.5||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1.5|-21.1|
71861120|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|7.0|||||TWO_SIDED|95.0|-2.5|16.8||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||16.8|-2.5|
71861121|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-3.0|||||TWO_SIDED|95.0|-9.5|4.1||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||4.1|-9.5|
71907455|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-12.06|STANDARD_ERROR_OF_MEAN|6.41||0.2|TWO_SIDED|95.0|-24.69|0.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||0.57|-24.69|0.20
71907456|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.6|STANDARD_ERROR_OF_MEAN|7.23||0.003|TWO_SIDED|95.0|-41.86|-13.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.35|-41.86|0.003
71907457|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-3.37|STANDARD_ERROR_OF_MEAN|6.49||1|TWO_SIDED|95.0|-16.16|9.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.43|-16.16|1.00
71907458|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.13|STANDARD_ERROR_OF_MEAN|7.18||0.053|TWO_SIDED|95.0|-32.28|-3.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-3.99|-32.28|0.053
71907459|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.72|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.34|-6.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.10|-27.34|0.073
71907460|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.31|STANDARD_ERROR_OF_MEAN|6.39||0.027|TWO_SIDED|95.0|-21.92|3.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||3.29|-21.92|0.027
71907461|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-2.67|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-13.05|7.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.72|-13.05|1.00
71907462|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|2.02|STANDARD_ERROR_OF_MEAN|6.43||0.63|TWO_SIDED|95.0|-10.66|14.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.69|-10.66|0.63
71907463|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.03|STANDARD_ERROR_OF_MEAN|7.08|<|0.001|TWO_SIDED|95.0|-32.03|-4.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.04|-32.03|<0.001
71907464|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.83|STANDARD_ERROR_OF_MEAN|6.52||0.007|TWO_SIDED|95.0|-32.71|-6.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-6.96|-32.71|0.007
71907465|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.55|STANDARD_ERROR_OF_MEAN|5.71||0.002|TWO_SIDED|95.0|-27.84|-5.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.26|-27.84|0.002
71907466|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-20.51|STANDARD_ERROR_OF_MEAN|5.33|<|0.001|TWO_SIDED|95.0|-31.04|-9.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.98|-31.04|<0.001
71907467|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.78|STANDARD_ERROR_OF_MEAN|5.62|<|0.001|TWO_SIDED|95.0|-32.88|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.68|-32.88|<0.001
71907468|NCT01763866|143336966|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.36|STANDARD_ERROR_OF_MEAN|6.45|<|0.001|TWO_SIDED|95.0|-44.1|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-18.62|-44.10|<0.001
71922065|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.5|STANDARD_ERROR_OF_MEAN|3.7|||TWO_SIDED|95.0|-7.2|8.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 15, Discharge||8.1|-7.2|
71861122|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-11.0|||||TWO_SIDED|95.0|-20.5|-1.0||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-1|-20.5|
71681504|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-5.6|||<|0.001|TWO_SIDED|95.0|-10.0|-1.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6A||-1.6|-10.0|< 0.001
71861123|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|6.0|||||TWO_SIDED|95.0|-4.2|15.4||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1||15.4|-4.2|
71861124|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-6.0|||||TWO_SIDED|95.0|-13.4|1.3||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2||1.3|-13.4|
71861125|NCT02035696|143236928|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-18.0|||||TWO_SIDED|95.0|-27.8|-7.2||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B||-7.2|-27.8|
71861126|NCT02035696|143236929|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
71861127|NCT02035696|143236929|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
71861128|NCT02035696|143236929|SUPERIORITY_OR_OTHER||Desirability Index Score|0.0|||||TWO_SIDED||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.|||||
71861129|NCT01536587|143236957|SUPERIORITY_OR_OTHER|||||||0.5062||95.0|||||paired t-Test, 2-sided|||||||0.5062
71861130|NCT01515943|143236999|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.0||||0.56|TWO_SIDED|97.5|-19.0|11.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Biniomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||11|-19|0.56
71861131|NCT01515943|143237000|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.0||||0.52|TWO_SIDED|97.5|-12.0|22.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Binomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (\<28 points vs ≥28 points), mean NPC break (\<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs \<15 pd).||22|-12|0.52
71907469|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.36|STANDARD_ERROR_OF_MEAN|4.38||0.088|TWO_SIDED|95.0|-21.99|-4.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.74|-21.99|0.088
71922066|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-11.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||10.2|-11.5|
71688715|NCT03749109|142892873|OTHER||Difference in LS mean|0.72||||0.74|TWO_SIDED|95.0|-3.63|5.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||5.07|-3.63|0.74
71861132|NCT01515943|143237006|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.0|||<|0.01|TWO_SIDED|95.0|-27.0|17.0|||Bernard's exact test|A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.||For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.||17|-27|<0.01
71861133|NCT05224843|143237013|OTHER||Percentage of enrolled from eligible|82.5|||||TWO_SIDED|95.0|73.7|88.8||||||||88.8|73.7|
71861134|NCT05224843|143237014|OTHER||Percentage of enrolled from eligible|100.0|||||TWO_SIDED|95.0|95.4|100.0||||||||100|95.4|
71861135|NCT05224843|143237016|OTHER||Percentage screened positive for EM|7.5|||||TWO_SIDED|95.0|3.5|15.4||||||||15.4|3.5|
71861136|NCT05224843|143237018|OTHER||Percentage who changed after BNI|25.0|||||TWO_SIDED|95.0|4.6|69.9||||||||69.9|4.6|
71861137|NCT05224843|143237019|OTHER||Percentage reported APS from EM positive|20.0|||||TWO_SIDED|95.0|3.6|62.4||||||||62.4|3.6|
71861138|NCT01245140|143237061|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5731||||0.9705|TWO_SIDED|95.0|-30.9738|32.12|||ANCOVA|||||32.1200|-30.9738|0.9705
71907470|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.31|STANDARD_ERROR_OF_MEAN|5.41||0.005|TWO_SIDED|95.0|-31.98|-10.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-10.64|-31.98|0.005
71907471|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.5|STANDARD_ERROR_OF_MEAN|4.45||1|TWO_SIDED|95.0|-10.27|7.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.27|-10.27|1.00
71907472|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-13.54|STANDARD_ERROR_OF_MEAN|5.39||0.056|TWO_SIDED|95.0|-24.17|-2.91||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-2.91|-24.17|0.056
71907473|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.21|STANDARD_ERROR_OF_MEAN|4.91||0.073|TWO_SIDED|95.0|-24.88|-5.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.54|-24.88|0.073
71907474|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.69|STANDARD_ERROR_OF_MEAN|5.21||0.027|TWO_SIDED|95.0|-24.97|-4.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.42|-24.97|0.027
71907475|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.44|STANDARD_ERROR_OF_MEAN|4.82||1|TWO_SIDED|95.0|-9.94|9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.05|-9.94|1.00
71907476|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-0.25|STANDARD_ERROR_OF_MEAN|5.28||0.62|TWO_SIDED|95.0|-10.66|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.16|-10.66|0.62
71907477|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.07|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-34.64|-15.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-15.50|-34.64|<0.001
71907478|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-19.79|STANDARD_ERROR_OF_MEAN|5.58||0.007|TWO_SIDED|95.0|-30.81|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.77|-30.81|0.007
71907479|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.15|STANDARD_ERROR_OF_MEAN|4.61||0.005|TWO_SIDED|95.0|-25.27|-7.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-7.03|-25.27|0.005
71907480|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.18|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|95.0|-32.11|-14.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-14.25|-32.11|<0.001
71907481|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-23.21|STANDARD_ERROR_OF_MEAN|4.95|<|0.001|TWO_SIDED|95.0|-33.0|-13.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-13.43|-33.00|<0.001
71907482|NCT01763866|143336967|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.87|STANDARD_ERROR_OF_MEAN|5.43|<|0.001|TWO_SIDED|95.0|-43.6|-22.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-22.14|-43.60|<0.001
71907483|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-14.47|STANDARD_ERROR_OF_MEAN|4.92||0.088|TWO_SIDED|95.0|-24.16|-4.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.78|-24.16|0.088
71907484|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-26.47|STANDARD_ERROR_OF_MEAN|7.22||0.005|TWO_SIDED|95.0|-40.71|-12.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-12.24|-40.71|0.005
71907485|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.54|STANDARD_ERROR_OF_MEAN|5.0||1|TWO_SIDED|95.0|-11.41|8.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.32|-11.41|1.00
71922067|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|6.7|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|-4.1|17.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 21, Follow-up||17.5|-4.1|
71907486|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-15.19|STANDARD_ERROR_OF_MEAN|7.21||0.056|TWO_SIDED|95.0|-29.4|-0.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-0.97|-29.40|0.056
71681505|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-5.7|4.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6B||4.0|-5.7|< 0.001
71681506|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.7|||<|0.001|TWO_SIDED|95.0|-1.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 7F||2.7|-1.1|< 0.001
71907487|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.42|STANDARD_ERROR_OF_MEAN|5.39||0.073|TWO_SIDED|95.0|-27.05|-5.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.80|-27.05|0.073
71907488|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-9.6|STANDARD_ERROR_OF_MEAN|6.13||0.027|TWO_SIDED|95.0|-21.68|2.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||2.48|-21.68|0.027
71907489|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-1.78|STANDARD_ERROR_OF_MEAN|5.27||1|TWO_SIDED|95.0|-12.16|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.61|-12.16|1.00
71907490|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.94|STANDARD_ERROR_OF_MEAN|6.18||0.62|TWO_SIDED|95.0|-7.25|17.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||17.14|-7.25|0.62
71907491|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-21.98|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-34.24|-9.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-9.73|-34.24|<0.001
71907492|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.75|STANDARD_ERROR_OF_MEAN|6.5||0.007|TWO_SIDED|95.0|-31.6|-5.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-5.90|-31.60|0.007
71907493|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-16.19|STANDARD_ERROR_OF_MEAN|5.7||0.005|TWO_SIDED|95.0|-27.46|-4.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-4.92|-27.46|0.005
71907494|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-18.54|STANDARD_ERROR_OF_MEAN|5.31|<|0.001|TWO_SIDED|95.0|-29.04|-8.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-8.05|-29.04|<0.001
71907495|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-22.45|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-33.09|-11.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||-11.81|-33.09|<0.001
71907496|NCT01763866|143336968|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.83|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-48.96|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||-24.70|-48.96|<0.001
71907497|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.53|STANDARD_ERROR_OF_MEAN|1.84||0.034|TWO_SIDED|95.0|2.91|10.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.15|2.91|0.034
71688716|NCT03749109|142892874|OTHER||Difference in LS mean|10.13||||0.42|TWO_SIDED|95.0|-14.74|35.0|||ANCOVA|ANCOVA adjusted for baseline lesion size.||||35.00|-14.74|0.42
71922068|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.3|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-9.1|9.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||9.6|-9.1|
71922069|NCT03091920|143364988|OTHER|No statistical testing was performed.|Least squares mean difference|0.8|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|-8.5|10.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 42, End of trial||10.2|-8.5|
71861139|NCT01245140|143237062|SUPERIORITY_OR_OTHER|||||||0.4564||95.0||||PPPASI 50 response|Fisher Exact|||||||0.4564
71861140|NCT01245140|143237062|SUPERIORITY_OR_OTHER|||||||0.6595||95.0||||PPPASI 75 response|Fisher Exact|||||||0.6595
71861141|NCT01245140|143237064|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||Change in Total Pustule Count: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.51
71861142|NCT01245140|143237065|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||Relative change in mPASI score: BL to Last Visit|Wilcoxon test: Exact Test|||||||0.12
71861143|NCT01245140|143237066|SUPERIORITY_OR_OTHER||Least squared estimation|49.4927||||0.2358|TWO_SIDED|95.0|-49.083|148.07|||ANCOVA|||||148.07|-49.0830|0.2358
71861144|NCT01245140|143237067|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 50 response|Fisher Exact|||||||0.1667
71861145|NCT01245140|143237067|SUPERIORITY_OR_OTHER|||||||0.1667||95.0||||mPASI 75 response|Fisher Exact|||||||0.1667
71861146|NCT04836559|143237086|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.3571|TWO_SIDED|95.0|0.41|1.38|||t-test, 1 sided|||||1.38|0.41|0.3571
71861147|NCT04836559|143237086|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.6306|TWO_SIDED|95.0|0.4|1.75|||t-test, 1 sided|||||1.75|0.40|0.6306
71861148|NCT02701062|143237126|SUPERIORITY|||||||0.2593|||||||Fisher Exact|||||||0.2593
71861149|NCT02701062|143237127|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71861150|NCT02701062|143237128|SUPERIORITY|||||||0.1238|||||||Fisher Exact|||||||0.1238
71861151|NCT02701062|143237129|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||LOS (Total)||||0.6603
71861152|NCT02701062|143237129|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
71861153|NCT02701062|143237129|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
71861154|NCT02701062|143237130|SUPERIORITY|||||||0.6603|||||||t-test, 2 sided|||||||0.6603
71861155|NCT02701062|143237130|SUPERIORITY|||||||0.0783|||||||t-test, 2 sided|||LOS (Post-Procedure)||||0.0783
71861156|NCT02701062|143237130|SUPERIORITY|||||||0.4282|||||||t-test, 2 sided|||Readmission LOS (per subject)||||0.4282
71861157|NCT02701062|143237131|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Reoperation||||0.5442
71861158|NCT02701062|143237131|SUPERIORITY|||||||0.2598|||||||Fisher Exact|||ED Visit||||0.2598
71861159|NCT02701062|143237131|SUPERIORITY|||||||0.5442|||||||Fisher Exact|||Neurologic Consult||||0.5442
71907498|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.11|STANDARD_ERROR_OF_MEAN|2.37||0.017|TWO_SIDED|95.0|3.43|12.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.79|3.43|0.017
71688717|NCT03749109|142892875|OTHER||Difference in LS mean|1.09||||0.1|TWO_SIDED|95.0|-0.2|2.38|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma||2.38|-0.20|0.10
71861160|NCT02701062|143237131|SUPERIORITY|||||||0.2921|||||||Fisher Exact|||Hospital Readmission (per subject)||||0.2921
71861161|NCT00781937|143237133|SUPERIORITY_OR_OTHER||Treatment Contrast|-6.06|||<|0.0001||95.0|-7.5|-4.62||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||-4.62|-7.50|<0.0001
71861162|NCT00781937|143237134|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.82|||<|0.0001||95.0|3.01|7.71||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||7.71|3.01|<0.0001
71861163|NCT00781937|143237135|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.44|6.09||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.||6.09|2.44|<0.0001
71861164|NCT00781937|143237136|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3|||<|0.0001||95.0|2.79|10.08||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.08|2.79|<0.0001
71861165|NCT00781937|143237137|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.09|||<|0.0001||95.0|0.03|0.26||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||0.26|0.03|<0.0001
71861166|NCT00781937|143237139|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.86|||<|0.0001||95.0|3.12|10.98||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||10.98|3.12|<0.0001
71861167|NCT00781937|143237140|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.02|||<|0.0001||95.0|3.65|9.92||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||||9.92|3.65|<0.0001
71861168|NCT00781937|143237141|SUPERIORITY_OR_OTHER||Treatment Contrast|-5.86|||<|0.0001||95.0|-7.3|-4.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-4.43|-7.30|<0.0001
71861169|NCT00781937|143237142|SUPERIORITY_OR_OTHER||Treatment Contrast|-4.23|||<|0.0001||95.0|-6.04|-2.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.43|-6.04|<0.0001
71861170|NCT00781937|143237143|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.72||||0.0068||95.0|-4.69|-0.76||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in systolic blood pressure.||-0.76|-4.69|0.0068
71861171|NCT00781937|143237143|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.34||||0.6386||95.0|-1.74|1.07||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in diastolic blood pressure.||1.07|-1.74|0.6386
71861172|NCT00781937|143237144|SUPERIORITY_OR_OTHER||Treatment Contrast|0.97||||0.1968||95.0|-0.51|2.45||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||2.45|-0.51|0.1968
71861173|NCT00781937|143237145|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.031||95.0|-0.2|-0.01||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.01|-0.20|0.0310
71861174|NCT00781937|143237146|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.09||||0.1098||95.0|-0.2|0.02||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.02|-0.20|0.1098
71861175|NCT00781937|143237147|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.11||||0.1149||95.0|-0.24|0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||0.03|-0.24|0.1149
71861176|NCT00781937|143237148|SUPERIORITY_OR_OTHER||Treatment Contrast|-13.01||||0.0141||95.0|-23.4|-2.64||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.64|-23.40|0.0141
71861177|NCT00781937|143237149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.1199||95.0|0.36|1.12||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.||||1.12|0.36|0.1199
71861178|NCT00781937|143237150|SUPERIORITY_OR_OTHER||Treatment Contrast|-3.5|||<|0.0001||95.0|-4.84|-2.15||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-2.15|-4.84|<0.0001
71861179|NCT00781937|143237151|SUPERIORITY_OR_OTHER||Treatment Contrast|-2.05|||<|0.0001||95.0|-2.53|-1.57||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-1.57|-2.53|<0.0001
71861180|NCT00781937|143237152|SUPERIORITY_OR_OTHER||Treatment Contrast|2.35||||0.3689||95.0|-2.79|7.49||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||7.49|-2.79|0.3689
71861181|NCT00781937|143237153|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.1||||0.0053||95.0|-0.16|-0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.03|-0.16|0.0053
71861182|NCT00781937|143237154|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.38|||<|0.0001||95.0|-0.5|-0.26||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.26|-0.50|<0.0001
71861183|NCT00781937|143237155|SUPERIORITY_OR_OTHER||Treatment Contrast|-1.85||||0.0147||95.0|-3.34|-0.37||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.37|-3.34|0.0147
71861184|NCT00781937|143237156|SUPERIORITY_OR_OTHER||Treatment Contrast|-0.27|||<|0.0001||95.0|-0.33|-0.21||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||||-0.21|-0.33|<0.0001
71861185|NCT00013611|143237159|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.47|TWO_SIDED|95.0|0.7|1.18|||Regression, Cox|Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.||Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.||1.18|0.70|0.47
71861186|NCT00013611|143237160|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.73|TWO_SIDED|95.0|0.77|1.44|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.44|0.77|0.73
71861187|NCT00013611|143237161|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1|TWO_SIDED|95.0|0.51|1.06|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.||||1.06|0.51|0.10
71861188|NCT00013611|143237162|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.35|TWO_SIDED|95.0|0.9|1.34|||Regression, Cox|||||1.34|0.90|0.35
71861189|NCT00013611|143237163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.0|STANDARD_ERROR_OF_MEAN|6.5|<|0.001|TWO_SIDED|95.0|40.3|65.7|||Mixed Models Analysis|||||65.7|40.3|< 0.001
71907499|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.67|STANDARD_ERROR_OF_MEAN|1.86||0.001|TWO_SIDED|95.0|3.0|10.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.34|3.00|0.001
71907500|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.57|STANDARD_ERROR_OF_MEAN|2.36||0.006|TWO_SIDED|95.0|3.93|13.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.22|3.93|0.006
71861190|NCT01013961|143237169|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|TWO_SIDED||||||Fisher Exact|||||||0.722
71861191|NCT01013961|143237170|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0
71922070|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|3.07|||TWO_SIDED|95.0|-9.68|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.04|-9.68|
71861192|NCT00607672|143237229|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||Mixed Models Analysis|||||||0.28
71922071|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-2.55|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|95.0|-8.76|3.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||3.66|-8.76|
71861193|NCT00607672|143237230|SUPERIORITY_OR_OTHER|||||||0.84||95.0|||||Mixed Models Analysis|||||||0.84
71861194|NCT00607672|143237231|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Kruskal-Wallis|||||||0.67
71861195|NCT00607672|143237232|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Chi-squared|||||||0.73
71861196|NCT00607672|143237233|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||For plasma transfusion comparison. Ramipril and Candesartan versus placebo|Chi-squared|||||||0.04
71861197|NCT00607672|143237234|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||Comparison for norepinephrine use|Chi-squared|||||||0.27
71861198|NCT00607672|143237235|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||Chi-squared|||||||0.62
71861199|NCT00607672|143237236|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|||||||0.51
71861200|NCT00607672|143237237|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Chi-squared|||||||0.87
71861201|NCT00607672|143237238|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|||||||0.04
71861202|NCT00607672|143237239|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Mixed Models Analysis|||||||0.69
71861203|NCT00607672|143237240|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||Mixed Models Analysis|||||||0.97
71861204|NCT00607672|143237241|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Mixed Models Analysis|||||||0.46
71861205|NCT04593823|143237260|SUPERIORITY||Win Ratio|1.11|||||TWO_SIDED|95.0|0.48|2.5|||||A win ratio parameter signifies the percentage of wins that a treatment group has achieved when compared against a comparator.|||2.50|0.48|
71861206|NCT04593823|143237261|SUPERIORITY||Mean Difference (Final Values)|2.9|||>|0.999|TWO_SIDED|95.0|-17.0|15.9|||Chi-squared|||||15.9|-17.0|>0.999
71861207|NCT04593823|143237262|SUPERIORITY||Median Difference (Final Values)|-8.8||||0.459|TWO_SIDED|95.0|-36.4|13.6|||Chi-squared|||||13.6|-36.4|0.459
71861208|NCT04593823|143237264|SUPERIORITY||Least Squares Mean Difference|8.887||||0.547|TWO_SIDED|95.0|-20.01|37.784|||ANOVA|Repeated measures analysis||||37.784|-20.010|0.547
71861209|NCT04593823|143237265|SUPERIORITY|||||||0.336|||||||Wilcoxon (Mann-Whitney)|||||||0.336
71861210|NCT00443209|143237290|SUPERIORITY_OR_OTHER||Treatment Difference|-6.2|||<|0.001|TWO_SIDED|95.0|-10.4|-2.6|||Miettenen and Nurminen method||Treatment Difference was compared using the Miettinen and Nurminen (MN) method.|||-2.6|-10.4|<0.001
71861211|NCT00443209|143237291|SUPERIORITY_OR_OTHER||Treatment Difference|-5.2|||||TWO_SIDED|95.0|-11.7|1.4|||||Treatment Difference was compared using the MN method.|||1.4|-11.7|
71861212|NCT00443209|143237292|SUPERIORITY_OR_OTHER||Treatment Difference|0.3|||||TWO_SIDED|95.0|-2.0|2.0|||||Treatment Difference was compared using the MN method.|||2.0|-2.0|
71861213|NCT00443209|143237294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||Based on mixed logistic regression model with a fixed effect term for treatment, baseline pain severity and a random effect term for participant, with the random effect following a normal distribution. An odds ratio \>1 is in favor of telcagepant.|||0.75|0.45|
71861214|NCT01653210|143237302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||ANOVA|||||||0.023
71861215|NCT01827046|143237344|SUPERIORITY||Risk Difference (RD)|2.0||||0.73|TWO_SIDED|95.0|-6.8|10.7|||Chi-squared|||||10.7|-6.8|0.73
71861216|NCT01827046|143237344|SUPERIORITY||Risk Difference (RD)|4.0||||0.33|TWO_SIDED|95.0|-4.0|12.0|||Multivariate logit model|||Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location||12|-4|0.33
71861217|NCT01827046|143237345|SUPERIORITY||Risk Difference (RD)|0.03||||0.55|TWO_SIDED|95.0|-0.06|0.11|||Chi-squared|||||0.11|-0.06|0.55
71861218|NCT01827046|143237345|SUPERIORITY||Risk Difference (RD)|1.26||||0.27|TWO_SIDED|95.0|0.82|1.97|||Multivariate logit model|Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location||||1.97|0.82|0.27
71861219|NCT01827046|143237346|SUPERIORITY|||||||0.08|TWO_SIDED|95.0|||||Log Rank|||||||0.08
71861220|NCT01827046|143237346|SUPERIORITY||Cox Proportional Hazard|0.67||||0.037|TWO_SIDED|95.0|0.45|0.98|||Adjusted Cox proportional Hazard|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.||||0.98|0.45|0.037
71861221|NCT01827046|143237347|SUPERIORITY||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.62|0.8|||Logit model|||||0.80|0.62|<0.001
71861222|NCT01827046|143237347|SUPERIORITY||Odds Ratio (OR)|0.68|||<|0.001|TWO_SIDED|95.0|0.59|0.78|||Multivariate logit model|Adjusted for age, GCS, stability IVH volume, and ICH deep location||||0.78|0.59|<0.001
71861223|NCT01827046|143237348|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71861224|NCT01827046|143237349|SUPERIORITY||Risk Difference (RD)|0.04||||0.34|TWO_SIDED|95.0|-0.04|0.11|||Chi-squared|||||0.11|-0.04|0.34
71861225|NCT01827046|143237350|SUPERIORITY||Risk Difference (RD)|-0.01||||0.76|TWO_SIDED|95.0|-0.1|0.07|||Chi-squared|||||0.07|-0.10|0.76
71861226|NCT01827046|143237350|SUPERIORITY||Odds Ratio (OR)|1.25||||0.31|TWO_SIDED|95.0|0.81|1.94|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.94|0.81|0.31
71861227|NCT01827046|143237351|SUPERIORITY||Risk Difference (RD)|0.01||||0.79|TWO_SIDED|95.0|-0.07|0.09|||Chi-squared|||||0.09|-0.07|0.79
71861228|NCT01827046|143237351|SUPERIORITY||Odds Ratio (OR)|1.24||||0.35|TWO_SIDED|95.0|0.79|1.97|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location||||1.97|0.79|0.35
71861229|NCT01827046|143237352|SUPERIORITY|||||||0.46|||||||Median test|||||||0.46
71861230|NCT01827046|143237353|SUPERIORITY|||||||0.75|||||||Median test|||||||0.75
71861231|NCT01827046|143237354|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71861232|NCT01827046|143237355|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
71861233|NCT01827046|143237356|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
71861234|NCT01827046|143237357|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71861235|NCT01827046|143237358|SUPERIORITY|||||||0.32|||||||Chi-squared|||||||0.32
71861236|NCT01827046|143237359|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71861237|NCT01827046|143237360|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71861238|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|2.39|||||TWO_SIDED|95.0|1.39|4.1|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||4.1|1.39|
71861239|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.71|||||TWO_SIDED|95.0|0.42|1.2|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||1.2|0.42|
71861240|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|1.68|||||TWO_SIDED|95.0|0.98|2.9|||ANOVA|||Day 1, Men A, Pairwise comparison of geometric mean titer||2.9|0.98|
71861241|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|1.31|||||TWO_SIDED|95.0|0.59|2.91|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||2.91|0.59|
71861242|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|11.0|52.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||52|11|
71907501|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.95|STANDARD_ERROR_OF_MEAN|2.1||0.85|TWO_SIDED|95.0|-0.19|8.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.09|-0.19|0.85
71907502|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.13|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|4.68|13.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.58|4.68|<0.001
71907503|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.57|STANDARD_ERROR_OF_MEAN|2.06||0.003|TWO_SIDED|95.0|3.51|11.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.64|3.51|0.003
71861243|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|31.0|||||TWO_SIDED|95.0|14.0|69.0|||ANOVA|||Day 8, Men A, Pairwise comparison of geometric mean titer||69|14|
71861244|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|1.3|||||TWO_SIDED|95.0|0.7|2.42|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||2.42|0.7|
71861245|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|5.56|||||TWO_SIDED|95.0|3.01|10.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||10|3.01|
71861246|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|7.22|||||TWO_SIDED|95.0|3.86|13.0|||ANOVA|||Day 29, Men A, Pairwise comparison of geometric mean titer||13|3.86|
71861247|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|2.64|||||TWO_SIDED|95.0|1.4|4.99|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||4.99|1.4|
71861248|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|1.05|||||TWO_SIDED|95.0|0.56|1.97|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||1.97|0.56|
71861249|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|2.78|||||TWO_SIDED|95.0|1.47|5.27|||ANOVA|||Day 1, Men C, Pairwise comparison of geometric mean titer||5.27|1.47|
71861250|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.52|||||TWO_SIDED|95.0|0.23|1.13|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||1.13|0.23|
71861251|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|45.0|||||TWO_SIDED|95.0|21.0|97.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||97|21|
71861252|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|23.0|||||TWO_SIDED|95.0|10.0|51.0|||ANOVA|||Day 8, Men C, Pairwise comparison of geometric mean titer||51|10|
71861253|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.4|||||TWO_SIDED|95.0|0.2|0.82|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||0.82|0.2|
71861254|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|24.0|||||TWO_SIDED|95.0|12.0|48.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||48|12|
71861255|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|9.61|||||TWO_SIDED|95.0|4.69|20.0|||ANOVA|||Day 29, Men C, Pairwise comparison of geometric mean titer||20|4.69|
71861256|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|1.11|||||TWO_SIDED|95.0|0.55|2.21|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||2.21|0.55|
71861257|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|2.51|||||TWO_SIDED|95.0|1.27|4.96|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||4.96|1.27|
71861258|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|2.77|||||TWO_SIDED|95.0|1.38|5.57|||ANOVA|||Day 1, Men W-135, Pairwise comparison of geometric mean titer||5.57|1.38|
71861259|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.54|||||TWO_SIDED|95.0|0.28|1.04|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.28|
71861260|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|50.0|||||TWO_SIDED|95.0|26.0|94.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||94|26|
71861261|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|27.0|||||TWO_SIDED|95.0|14.0|52.0|||ANOVA|||Day 8, Men W-135, Pairwise comparison of geometric mean titer||52|14|
71861262|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.6|||||TWO_SIDED|95.0|0.34|1.04|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||1.04|0.34|
71861263|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|35.0|||||TWO_SIDED|95.0|20.0|60.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||60|20|
71861264|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|21.0|||||TWO_SIDED|95.0|12.0|36.0|||ANOVA|||Day 29, Men W-135, Pairwise comparison of geometric mean titer||36|12|
71861265|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.9|||||TWO_SIDED|95.0|0.48|1.69|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||1.69|0.48|
71861266|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|3.61|||||TWO_SIDED|95.0|1.94|6.74||||||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.74|1.94|
71861267|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|3.24|||||TWO_SIDED|95.0|1.71|6.13|||ANOVA|||Day 1, Men Y, Pairwise comparison of geometric mean titer||6.13|1.71|
71861268|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.33|||||TWO_SIDED|95.0|0.16|0.66|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||0.66|0.16|
71861269|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|121.0|||||TWO_SIDED|95.0|61.0|241.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||241|61|
71861270|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|40.0|||||TWO_SIDED|95.0|20.0|80.0|||ANOVA|||Day 8, Men Y, Pairwise comparison of geometric mean titer||80|20|
71861271|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|0.58|||||TWO_SIDED|95.0|0.32|1.05|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||1.05|0.32|
71861272|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|33.0|||||TWO_SIDED|95.0|18.0|60.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||60|18|
71861273|NCT01018732|143237397|SUPERIORITY_OR_OTHER||ratio of titer|19.0|||||TWO_SIDED|95.0|10.0|35.0|||ANOVA|||Day 29, Men Y, Pairwise comparison of geometric mean titer||35|10|
71861274|NCT02781311|143237505|SUPERIORITY||Least-squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|4.45||0.9239|TWO_SIDED|95.0|-8.38|9.23||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.|ANCOVA|||||9.23|-8.38|0.9239
71861275|NCT02781311|143237506|SUPERIORITY||Least-squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.9101|TWO_SIDED|95.0|-0.42|0.37||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.|ANCOVA|||||0.37|-0.42|0.9101
71861276|NCT02165826|143237511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.017|TWO_SIDED|95.0|0.47|0.93||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.93|0.47|0.017
71861277|NCT02165826|143237511|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.68|||||TWO_SIDED|95.0|0.51|0.92|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||0.92|0.51|
71861278|NCT02165826|143237511|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.114|TWO_SIDED|95.0|0.55|1.07||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.07|0.55|0.114
71861279|NCT02165826|143237511|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.77|||||TWO_SIDED|95.0|0.58|1.02|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.||1.02|0.58|
71861280|NCT02165826|143237512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.63||||0.001|TWO_SIDED|95.0|0.47|0.83||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||0.83|0.47|0.001
71861281|NCT02165826|143237512|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.59|1.04||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.||1.04|0.59|0.091
71861282|NCT00250432|143237540|NON_INFERIORITY_OR_EQUIVALENCE|Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).|Rate Difference|1.1|STANDARD_ERROR_OF_MEAN|5.6||||95.0|-4.1|6.8|||||The confidence interval computation was based on the method by Miettinen and Nurminen.|A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.||6.8|-4.1|
71861283|NCT00250432|143237541|SUPERIORITY_OR_OTHER||Rate Difference|6.3|STANDARD_ERROR_OF_MEAN|12.1||||95.0|-5.9|18.4|||||The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.|There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.||18.4|-5.9|
71861284|NCT06314438|143237543|EQUIVALENCE|paired samples t test with significance set at 0.05 p value||||||0.34|||||||t-test, 2 sided|||||||0.34
71861285|NCT06314438|143237544|EQUIVALENCE|paired samples t test with significance level at 0.05||||||0.05|||||||t-test, 2 sided|||||||0.05
71861286|NCT06314438|143237545|EQUIVALENCE|paired samples t test with significance set at 0.05 p value|||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71861287|NCT03512197|143237548|SUPERIORITY||Hazard Ratio (HR)|1.0239|||||TWO_SIDED|95.0|0.8|1.31||||||||1.31|0.8|
71861288|NCT03512197|143237549|SUPERIORITY||Hazard Ratio (HR)|0.8728|||||TWO_SIDED|95.0|0.59|1.29||||||||1.29|0.59|
71861289|NCT03512197|143237554|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.6|1.63||||||||1.63|0.60|
71861290|NCT03512197|143237555|SUPERIORITY||Hazard Ratio (HR)|1.5866|||||TWO_SIDED|95.0|0.88|2.87||||||||2.87|0.88|
71861291|NCT03512197|143237556|SUPERIORITY||Hazard Ratio (HR)|0.7937|||||TWO_SIDED|95.0|0.41|1.54||||||||1.54|0.41|
71861292|NCT03512197|143237558|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.16||||||partial neutrophil recovery||1.16|0.75|
71861293|NCT03512197|143237558|SUPERIORITY||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.72|1.14||||||full neutrophil recovery||1.14|0.72|
71861294|NCT03512197|143237559|SUPERIORITY||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.87|1.52||||||partial platelet recovery||1.52|0.87|
71861295|NCT03512197|143237559|SUPERIORITY||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.67|1.0||||||full platelet recovery||1.00|0.67|
71861296|NCT02201901|143237584|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
71681507|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.3|||<|0.001|TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 9V||4.6|-1.9|< 0.001
71861297|NCT02201901|143237584|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
71861298|NCT02201901|143237584|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.||||<0.001
71861299|NCT03358238|143237592|OTHER||Proportion|0.404|||||TWO_SIDED|95.0|0.264|0.557|||||Type of confidence interval = Clopper-Pearson|||0.557|0.264|
71861300|NCT03358238|143237593|SUPERIORITY||Difference in Average Proportions|0.0017||||0.99|TWO_SIDED|95.0|-0.1774|0.1807||Statistical significance was an alpha level of 0.05.|t-test, 2 sided|Two-sample t test. Degrees of freedom = 45.|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates of self-reporting between arms was zero.||0.1807|-0.1774|0.99
71861301|NCT03358238|143237594|SUPERIORITY||Risk Difference (RD)|-0.0189||||0.85|TWO_SIDED|95.0|-0.2215|0.1837||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|Two-sample t-test. Degrees of freedom = 45|Two-sample t confidence intervals|Null hypothesis was that the difference in average adherence rates to activity tracking between arms was zero.||0.1837|-0.2215|0.85
71861302|NCT03358238|143237595|OTHER||Proportion|0.5385|||||TWO_SIDED|95.0|0.3718|0.6991|||||Type of confidence interval = Clopper-Pearson|Estimating proportion of individuals with higher adherence rates for self-report over activity tracking among individuals with unequal adherence rates||0.6991|0.3718|
71861303|NCT03358238|143237595|SUPERIORITY|||||||0.0828|||||||Chi-squared|Degrees of freedom = 1||Null hypothesis is that among individuals with unequal adherence rates, the proportion of individuals with greater adherence to self-report over activity tracking in the Review Arm is equal to the proportion of individuals with greater adherence to self-report over activity tracking in the No Review Arm.||||0.0828
71861304|NCT03358238|143237596|OTHER||Mean Difference (Net)|0.79||||0.2|TWO_SIDED|95.0|-0.42|1.99||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t-test. Degrees of freedom = 46.|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~One-sample t confidence intervals."|"One participant had a single item missing on the Young Mania Rating Scale administered at study start. A zero was imputed for the missing item to recover a total score.~Null hypothesis was that the average change in total scores was zero."||1.99|-0.42|0.20
71861305|NCT03358238|143237597|OTHER||Mean Difference (Net)|0.89||||0.32|TWO_SIDED|95.0|-0.91|2.7||Statistical significance was considered an alpha level of 0.05.|t-test, 2 sided|One-sample t test. Degrees of freedom = 46|One-sample t confidence intervals|Null hypothesis was that average change in scores on the structured interview guide for the Hamilton rating scale for depression is zero.||2.70|-0.91|0.32
71861306|NCT01867047|143237614|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for intraoperative mild hypotension||||0.140
71861307|NCT01867047|143237614|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Statistical analysis for postoperative mild hypotension||||1.000
71861308|NCT01867047|143237616|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||Analysis for number of participants given vasopressors intraoperatively||||0.102
71861309|NCT01867047|143237619|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.700
71861310|NCT01867047|143237620|SUPERIORITY|||||||0.702|||||||t-test, 2 sided|||||||0.702
71861311|NCT00349466|143237621|SUPERIORITY|||||||0.027|||||||ANCOVA|||||||0.027
71907504|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.35|STANDARD_ERROR_OF_MEAN|2.28||0.003|TWO_SIDED|95.0|3.86|12.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.84|3.86|0.003
71907505|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.36|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|1.68|9.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.04|1.68|<0.001
71688718|NCT03749109|142892875|OTHER||Difference in LS mean|0.28||||0.67|TWO_SIDED|95.0|-1.02|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE||1.58|-1.02|0.67
71688719|NCT03749109|142892875|OTHER||Difference in LS mean|0.32||||0.64|TWO_SIDED|95.0|-1.06|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis||1.71|-1.06|0.64
71861312|NCT00349466|143237622|SUPERIORITY|||||||0.083|||||||ANCOVA|||||||0.083
71861313|NCT00349466|143237623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|TWO_SIDED|95.0|||||Fisher Exact|||||||0.028
71861314|NCT00349466|143237624|SUPERIORITY|||||||0.655|||||||Fisher Exact|||||||0.655
71861315|NCT00349466|143237625|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.387
71861316|NCT00349466|143237626|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
71861317|NCT00349466|143237627|SUPERIORITY|||||||0.807|||||||ANCOVA|||||||.807
71907506|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.66|STANDARD_ERROR_OF_MEAN|3.11||0.01|TWO_SIDED|95.0|2.51|14.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||14.80|2.51|0.010
71907507|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.46|STANDARD_ERROR_OF_MEAN|1.91||0.013|TWO_SIDED|95.0|1.69|9.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.23|1.69|0.013
71907508|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.75|STANDARD_ERROR_OF_MEAN|2.2||0.002|TWO_SIDED|95.0|2.4|11.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.10|2.40|0.002
71907509|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|10.23|STANDARD_ERROR_OF_MEAN|2.58|<|0.001|TWO_SIDED|95.0|5.13|15.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.32|5.13|<0.001
71907510|NCT01763866|143336969|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.85|STANDARD_ERROR_OF_MEAN|2.09|<|0.001|TWO_SIDED|95.0|4.73|12.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||12.97|4.73|<0.001
71907511|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|6.83|STANDARD_ERROR_OF_MEAN|2.11||0.034|TWO_SIDED|95.0|2.66|10.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||10.99|2.66|0.034
71907512|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|2.46||0.017|TWO_SIDED|95.0|3.01|12.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.73|3.01|0.017
71907513|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.81|STANDARD_ERROR_OF_MEAN|2.14||0.001|TWO_SIDED|95.0|4.58|13.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.03|4.58|0.001
71907514|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.28|STANDARD_ERROR_OF_MEAN|2.45||0.006|TWO_SIDED|95.0|3.46|13.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.11|3.46|0.006
71907515|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.07|STANDARD_ERROR_OF_MEAN|2.28||0.85|TWO_SIDED|95.0|-0.42|8.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||8.57|-0.42|0.85
71861318|NCT01434680|143237643|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.82|||<|0.05|TWO_SIDED|95.0|0.67|1.0|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.00|0.67|<0.05
71861319|NCT01434680|143237643|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|1.14|||<|0.05|TWO_SIDED|95.0|0.92|1.41|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).||1.41|0.92|<0.05
71861320|NCT01434680|143237644|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.72|||<|0.05|TWO_SIDED|95.0|0.58|0.89|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).||0.89|0.58|<0.05
71861321|NCT01952847|143237661|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71861322|NCT01952847|143237662|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71861323|NCT01952847|143237665|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71861324|NCT01952847|143237666|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
71861325|NCT01952847|143237667|SUPERIORITY|||||||0.73|||||||Fisher Exact|||||||0.73
71861326|NCT01952847|143237668|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71861327|NCT01952847|143237669|OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71861328|NCT01952847|143237670|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71861329|NCT01952847|143237671|SUPERIORITY|||||||0.57|||||||Log Rank|||||||0.57
71861330|NCT01952847|143237675|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||||||0.83
71861331|NCT01952847|143237676|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71861332|NCT03334253|143237724|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.02|||||TWO_SIDED|95.0|-0.19|0.15|||||Atropine - Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.15|-0.19|
71861333|NCT03334253|143237725|SUPERIORITY|"The following assumptions were used in the power calculation:~* 2:1 randomization~* treatment group difference of 0.50D~* standard deviation of 0.80D~* type 1 error of 5% (2-sided)~* up to 10% loss to follow up"|Adjusted mean difference|-0.04|||||TWO_SIDED|95.0|-0.25|0.17|||||Atropine-Placebo Adjusted mean difference, adjusting for baseline refractive error, age, iris color (brown vs. not brown), and race (East Asian vs. non-East Asian).|Null Hypothesis: no difference in mean change in SER from baseline to 24 months between the atropine and placebo groups||0.17|-0.25|
71861334|NCT00203047|143237726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.11820976||0.8023|TWO_SIDED|95.0|-0.26|0.2|||ANCOVA|||||0.20|-0.26|0.8023
71861335|NCT00340704|143237750|SUPERIORITY_OR_OTHER||Slope|1.0039|STANDARD_ERROR_OF_MEAN|0.1725||||95.0|0.6499|1.3579|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality for Cmax,ss was explored based on the regression model.||1.3579|0.6499|
71688720|NCT03749109|142892876|OTHER||Difference in LS mean|0.21||||0.73|TWO_SIDED|95.0|-1.02|1.44|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 1||1.44|-1.02|0.73
71861336|NCT00340704|143237754|SUPERIORITY_OR_OTHER||Slope|0.98|STANDARD_ERROR_OF_MEAN|0.1884||||95.0|0.5934|1.3666|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.|Dose proportionality for AUCτ,ss was explored based on the regression model.||1.3666|0.5934|
71861337|NCT00121667|143237762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.92|-0.53||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.53|-0.92|<.0001
71907516|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.05|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|2.22|11.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.89|2.22|<0.001
71922072|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-2.93|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-8.62|2.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.75|-8.62|
71861338|NCT00121667|143237762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.02|-0.63||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.63|-1.02|<.0001
71861339|NCT00121667|143237762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.91|-0.52||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-0.52|-0.91|<.0001
71907517|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|8.47|STANDARD_ERROR_OF_MEAN|2.23||0.003|TWO_SIDED|95.0|4.07|12.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||12.87|4.07|0.003
71688721|NCT03749109|142892876|OTHER||Difference in LS mean|0.42||||0.54|TWO_SIDED|95.0|-0.97|1.82|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||1.82|-0.97|0.54
71861340|NCT00121667|143237763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.55|STANDARD_ERROR_OF_MEAN|3.56|<|0.0001|TWO_SIDED|95.0|-22.55|-8.55||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-8.55|-22.55|<.0001
71861341|NCT00121667|143237763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.28|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-30.29|-16.27||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-16.27|-30.29|<.0001
71861342|NCT00121667|143237763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.74|STANDARD_ERROR_OF_MEAN|3.6|<|0.0001|TWO_SIDED|95.0|-28.81|-14.68||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-14.68|-28.81|<.0001
71861343|NCT00121667|143237764|SUPERIORITY_OR_OTHER||Difference in Proportions|20.5|||<|0.0001|TWO_SIDED|95.0|10.6|30.5||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||30.5|10.6|<.0001
71861344|NCT00121667|143237764|SUPERIORITY_OR_OTHER||Difference in Proportions|27.0|||<|0.0001|TWO_SIDED|95.0|17.0|36.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||36.7|17.0|<.0001
71861345|NCT00121667|143237764|SUPERIORITY_OR_OTHER||Difference in Proportions|27.9|||<|0.0001|TWO_SIDED|95.0|17.7|37.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.||||37.7|17.7|<.0001
71861346|NCT00121667|143237765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5599.0|STANDARD_ERROR_OF_MEAN|1168.2|<|0.0001|TWO_SIDED|95.0|-7894.0|-3305.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3305|-7894|<.0001
71861347|NCT00121667|143237765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6294.0|STANDARD_ERROR_OF_MEAN|1176.8|<|0.0001|TWO_SIDED|95.0|-8606.0|-3983.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-3983|-8606|<.0001
71861348|NCT00121667|143237765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4845.0|STANDARD_ERROR_OF_MEAN|1175.1|<|0.0001|TWO_SIDED|95.0|-7153.0|-2537.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment|||-2537|-7153|<.0001
71861349|NCT01453023|143237797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||||TWO_SIDED|95.0|-8.8|0.4|||||Day 1 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||0.4|-8.8|
71907518|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.14|STANDARD_ERROR_OF_MEAN|2.46||0.003|TWO_SIDED|95.0|2.29|11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||11.99|2.29|0.003
71861350|NCT01453023|143237797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7|||||TWO_SIDED|95.0|-1.1|8.5|||||Day 14 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||8.5|-1.1|
71861351|NCT01453023|143237798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|-4.4|6.7|||||Day 1 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||6.7|-4.4|
71922073|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-3.23|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-10.37|3.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||3.92|-10.37|
71861352|NCT01453023|143237798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-6.0|5.5|||||Day 14 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.|||5.5|-6.0|
71681508|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-0.2|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 14||4.7|-0.2|< 0.001
71681509|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.2|||<|0.001|TWO_SIDED|95.0|-2.1|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 18C||4.7|-2.1|< 0.001
71688722|NCT03749109|142892876|OTHER||Difference in LS mean|-0.5||||0.46|TWO_SIDED|95.0|-1.86|0.85|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 3||0.85|-1.86|0.46
71861353|NCT01512797|143237849|OTHER|||||||0.028||||||P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.|t-test, 2 sided|||Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120' post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power \> 90%.||||0.028
71861354|NCT01080300|143237858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|0.311||0.0003|TWO_SIDED|95.0|-2.31|-1.09||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Eltereen|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 4."||-1.09|-2.31|0.0003
71861355|NCT01080300|143237858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.14|STANDARD_ERROR_OF_MEAN|0.335||0.1|TWO_SIDED|95.0|-1.8|-0.48||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12."||-0.48|-1.80|0.1000
71861356|NCT01080300|143237859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|-0.31|-0.1||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 4."||-0.10|-0.31|<0.0001
71861357|NCT01080300|143237859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.072||0.0004|TWO_SIDED|95.0|-0.33|-0.04||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 12."||-0.04|-0.33|0.0004
71861358|NCT01080300|143237860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.08|STANDARD_ERROR_OF_MEAN|0.453||0.151|TWO_SIDED|95.0|-1.98|-0.19|||Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily number of moderate to severe hot flashes at Week 24."||-0.19|-1.98|0.1510
71861359|NCT01080300|143237861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.11||0.0004|TWO_SIDED|95.0|-0.44|0.0|||Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily severity score of moderate to severe hot flashes at Week 24."||-0.00|-0.44|0.0004
71861360|NCT01080300|143237862|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.6||||0.0008|TWO_SIDED|95.0|5.7|21.6|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the PGIC score at week 12.."||21.6|5.7|0.0008
71861361|NCT01080300|143237862|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|13.4||||0.0009|TWO_SIDED|95.0|5.5|21.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 24."||21.3|5.5|0.0009
71907519|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|3.2|STANDARD_ERROR_OF_MEAN|2.3|<|0.001|TWO_SIDED|95.0|-1.33|7.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||7.73|-1.33|<0.001
71907520|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|7.35|STANDARD_ERROR_OF_MEAN|3.23||0.01|TWO_SIDED|95.0|0.97|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||13.72|0.97|0.010
71907521|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|5.04|STANDARD_ERROR_OF_MEAN|2.29||0.013|TWO_SIDED|95.0|0.52|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.56|0.52|0.013
71907522|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|4.84|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|0.07|9.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||9.60|0.07|0.002
71907523|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.78|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|4.05|15.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||||15.51|4.05|<0.001
71861362|NCT01080300|143237863|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.4|||<|0.0001|TWO_SIDED|95.0|8.4|24.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the CGIC score at week 12."||24.3|8.4|<0.0001
71861363|NCT01080300|143237863|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.007|TWO_SIDED|95.0|3.0|19.0|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||19.0|3.0|0.0070
71861364|NCT01080300|143237864|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.5||||0.0609|TWO_SIDED|95.0|-0.3|15.2|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||15.2|-0.3|0.0609
71861365|NCT01080300|143237864|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|7.3||||0.072|TWO_SIDED|95.0|-0.7|15.3|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||15.3|-0.7|0.0720
71861366|NCT01080300|143237865|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|3.8||||0.1825|TWO_SIDED|95.0|-1.8|9.4|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12||9.4|-1.8|0.1825
71861367|NCT01080300|143237865|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|4.4||||0.1662|TWO_SIDED|95.0|-1.8|10.7|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24||10.7|-1.8|0.1662
71861368|NCT01080300|143237866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|STANDARD_ERROR_OF_MEAN|0.196|<|0.0001|TWO_SIDED|95.0|-1.75|-0.97||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily sleep interference rating.||-0.97|-1.75|<0.0001
71861369|NCT01080300|143237866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.92|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|-1.36|-0.47||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily sleep interference rating.||-0.47|-1.36|<0.0001
71861370|NCT01080300|143237866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.95|STANDARD_ERROR_OF_MEAN|0.237|<|0.0001|TWO_SIDED|95.0|-1.42|-0.49||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily sleep interference rating.||-0.49|-1.42|<0.0001
71861371|NCT01080300|143237867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.62|STANDARD_ERROR_OF_MEAN|0.537|<|0.0001|TWO_SIDED|95.0|-3.67|-1.56||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily insomnia severity index (ISI) rating.||-1.56|-3.67|<0.0001
71861372|NCT01080300|143237867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.85|STANDARD_ERROR_OF_MEAN|0.543||0.0007|TWO_SIDED|95.0|-2.92|-0.78||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily insomnia severity index (ISI) rating.||-0.78|-2.92|0.0007
71861373|NCT01080300|143237867|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.76|STANDARD_ERROR_OF_MEAN|0.548||0.0014|TWO_SIDED|95.0|-2.84|-0.69|||ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily insomnia severity index (ISI) rating.||-0.69|-2.84|0.0014
71861374|NCT01080300|143237868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.084||0.0137|TWO_SIDED|95.0|-0.37|-0.04||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 4||-0.04|-0.37|0.0137
71861375|NCT01080300|143237868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.084||0.0872|TWO_SIDED|95.0|-0.31|0.02||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 12||0.02|-0.31|0.0872
71861376|NCT01080300|143237868|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.091||0.5607|TWO_SIDED|95.0|-0.23|0.13||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 24||0.13|-0.23|0.5607
71861377|NCT00965497|143237897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|95.0||||0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.||||0.01
71861378|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861379|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861380|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861381|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861382|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861383|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861384|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861385|NCT01299480|143237903|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861386|NCT01299480|143237905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB80 \[A22\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861387|NCT01299480|143237905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2001 \[A56\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861388|NCT01299480|143237905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2948 \[B24\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861389|NCT01299480|143237905|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Binomial Distribution|||PMB2707 \[B44\]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value \<0.0125 was considered significant.||||<0.001
71861390|NCT02296892|143237914|SUPERIORITY||Difference in Rates|0.7588|||<|0.0001|TWO_SIDED|95.0|0.6903|0.8274|||Cochran-Mantel-Haenszel|||||0.8274|0.6903|<0.0001
71861391|NCT01936467|143237920|OTHER||Sensitivity|93.7|||||TWO_SIDED|||||||||||||
71861392|NCT01936467|143237920|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
71861393|NCT01936467|143237921|OTHER||Sensitivity|88.6|||||TWO_SIDED|||||||||||||
71861394|NCT01936467|143237921|OTHER||Specificity|100.0|||||TWO_SIDED|||||||||||||
71861395|NCT01936467|143237922|OTHER|||||||0.47|||||||Chi-squared|||||||0.47
71861396|NCT01936467|143237923|SUPERIORITY_OR_OTHER|||||||0.71|||||||Chi-squared|||||||0.71
71861397|NCT01936467|143237924|SUPERIORITY_OR_OTHER|||||||0.15|||||||Chi-squared|||||||0.15
71861398|NCT01936467|143237925|SUPERIORITY_OR_OTHER|||||||0.46|||||||Chi-squared|||||||0.46
71861399|NCT04547023|143237926|OTHER||Mean Difference (Final Values)|18.7||||0.002|TWO_SIDED|95.0|7.2|30.1|||Fisher Exact|||||30.1|7.2|0.002
71861400|NCT03784820|143237954|SUPERIORITY||Odds Ratio (OR)|0.35||||0.36|TWO_SIDED|95.0|0.04|3.27||Comparison of Patients at Post (T2) \[CBT-E is the reference\]|Mixed Models Analysis|||||3.27|0.04|0.36
71861401|NCT03784820|143237954|SUPERIORITY||Odds Ratio (OR)|0.29||||0.38|TWO_SIDED|95.0|0.02|4.6||Comparison of Patients at 3 Month Fup (T3) \[CBT-E is the reference\]|Mixed Models Analysis|||||4.60|0.02|0.38
71861402|NCT03784820|143237954|SUPERIORITY||Odds Ratio (OR)|2.2||||0.54|TWO_SIDED|95.0|0.18|27.39||Comparison of Patients at 6 Month Fup (T4) \[CBT-E is the reference\]|Mixed Models Analysis|||||27.39|0.18|0.54
71861403|NCT03784820|143237955|SUPERIORITY||LS mean difference|0.51||||0.52|TWO_SIDED|95.0|-1.06|2.09||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.09|-1.06|0.52
71861404|NCT03784820|143237955|SUPERIORITY||LS mean difference|0.04||||0.97|TWO_SIDED|95.0|-1.99|2.07||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.07|-1.99|0.97
71861405|NCT03784820|143237955|SUPERIORITY||LS mean difference|0.62||||0.59|TWO_SIDED|95.0|-1.66|2.89||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.89|-1.66|0.59
71907524|NCT01763866|143336970|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|9.06|STANDARD_ERROR_OF_MEAN|2.36|<|0.001|TWO_SIDED|95.0|4.4|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||||13.72|4.40|<0.001
71907525|NCT03245723|143336974|OTHER|Descriptive statistics||||||0.38|||||||Wilcoxon Rank Sum test|||||||0.38
71907526|NCT03245723|143336975|OTHER|Descriptive statistics||||||0.12|||||||Wilcoxon Rank Sum test|||||||0.12
71907527|NCT03337139|143336976|SUPERIORITY|||||||0.98||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week weight loss, prior to randomization.||||.98
71907528|NCT03337139|143336976|SUPERIORITY|||||||0.75||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 26 week weight loss||||.75
71907529|NCT03337139|143336976|SUPERIORITY|||||||0.02||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I weight loss||Comparing groups on 52 week weight loss||||.02
71907530|NCT03337139|143336977|SUPERIORITY|||||||0.12||||||A priori threshold for statistical significance was p \<.05.|ANCOVA|||Comparing groups on 13 week MVPA||||.12
71907531|NCT03337139|143336977|SUPERIORITY|||||||0.16||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for changes in Phase I MVPA||Comparing groups on 52 week MVPA||||.16
71907532|NCT03337139|143336978|SUPERIORITY|||||||0.43||||||A priori threshold for statistical significant was p\<.05.|Fisher Exact|||Comparing groups on 26 week retention rates||||.43
71907533|NCT03337139|143336978|SUPERIORITY|||||||0.48||||||A priori threshold for statistical significance was p\<.05.|Fisher Exact|||Comparing groups on 52 week retention rates.||||.48
71907534|NCT03337139|143336979|SUPERIORITY|||||||0.64||||||A priori threshold of statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on phone calls completed in Phase II (52 weeks)||||.64
71907535|NCT03337139|143336979|SUPERIORITY|||||||0.499||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on text messages completed in Phase II (52 weeks)||||.499
71907536|NCT03337139|143336980|SUPERIORITY|||||||0.86||||||A priori threshold for statistical significance was p\<.05.|Permutation test|Permutation test (nonparametric test) was chosen due to the violation of t-test assumptions in the data set.||Comparing groups on TAQ scores at 52 weeks||||.86
71907537|NCT03337139|143336981|SUPERIORITY|||||||0.002||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of weight during Phase II||||.002
71907538|NCT03337139|143336981|SUPERIORITY|||||||0.001||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of eating during Phase II||||.001
71861406|NCT03784820|143237956|SUPERIORITY||LS mean difference|0.05||||0.86|TWO_SIDED|95.0|-0.45|0.54||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.54|-0.45|0.86
71861407|NCT03784820|143237956|SUPERIORITY||LS mean difference|0.3||||0.44|TWO_SIDED|95.0|-0.46|1.06||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||1.06|-0.46|0.44
71907539|NCT03337139|143336981|SUPERIORITY|||||||0.25||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I engagement in self-monitoring||Comparing groups on percent days of self-monitoring of physical activity during Phase II||||.25
71907540|NCT03337139|143336982|SUPERIORITY|||||||0.005||||||A priori threshold for statistical significance was p\<.05.|ANCOVA|Controlling for Phase I perceived supportive accountability||Comparing groups on changes in perceived accountability during Phase II||||.005
71907541|NCT02554253|143336983|SUPERIORITY|Pilot study||||||0.23|||||||Fisher Exact|||Raw scores converted to z-scores using published references. Percentage of patients experiencing a decline of \> 1 standard deviation was compared between groups using Fisher's exact test. The outcome of postoperative cognitive dysfunction (POCD) was defined a-priori as a decline of decline of \>1 standard deviation (i.e. z-score decline of \> 1) on at least 2 neurocognitive tests and was compared between groups using Fisher's exact test.||||0.23
71907542|NCT02554253|143336984|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
71907543|NCT02554253|143336985|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71907544|NCT01998269|143337007|SUPERIORITY_OR_OTHER||correlation coefficient|0.6|||<|0.001|TWO_SIDED||||||Correlation||r= 0.60, p-value\<0.001. P values below 0.05 are considered statistically significant in this study.|We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.||||<.001
71907545|NCT02559206|143337014|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||mixed model repeated measures (MMRM)|||||0.076|-1.214|0.0839
71907546|NCT02559206|143337014|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.297||||0.3661|TWO_SIDED|95.0|-0.942|0.348|||MMRM|||||0.348|-0.942|0.3661
71907547|NCT02559206|143337014|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.286||||0.3869|TWO_SIDED|95.0|-0.936|0.363|||MMRM|||||0.363|-0.936|0.3869
71907548|NCT02559206|143337014|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.771||||0.0199|TWO_SIDED|95.0|-1.419|-0.123|||MMRM|||||-0.123|-1.419|0.0199
71907549|NCT02559206|143337014|SUPERIORITY|||||||0.0276||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0276
71907550|NCT02559206|143337015|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|TWO_SIDED|95.0|-1.214|0.076|||MMRM|||||0.076|-1.214|0.0839
71861408|NCT03784820|143237956|SUPERIORITY||LS mean difference|0.31||||0.36|TWO_SIDED|95.0|-0.36|0.98||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.98|-0.36|0.36
71861409|NCT03784820|143237957|SUPERIORITY||LS mean difference|2.47||||0.33|TWO_SIDED|95.0|-2.54|7.49||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||7.49|-2.54|0.33
71907551|NCT02559206|143337015|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.455||||0.1669|TWO_SIDED|95.0|-1.102|0.191|||MMRM|||||0.191|-1.102|0.1669
71907552|NCT02559206|143337015|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.299||||0.3637|TWO_SIDED|95.0|-0.947|0.348|||MMRM|||||0.348|-0.947|0.3637
71907553|NCT02559206|143337015|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.258||||0.4333|TWO_SIDED|95.0|-0.905|0.389|||MMRM|||||0.389|-0.905|0.4333
71907554|NCT02559206|143337015|SUPERIORITY|||||||0.5528||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.5528
71907555|NCT02559206|143337016|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
71907556|NCT02559206|143337016|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.048||||0.9013|TWO_SIDED|95.0|-0.716|0.812|||MMRM|||||0.812|-0.716|0.9013
71907557|NCT02559206|143337016|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.299||||0.4447|TWO_SIDED|95.0|-0.469|1.067|||MMRM|||||1.067|-0.469|0.4447
71907558|NCT02559206|143337016|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.662||||0.0904|TWO_SIDED|95.0|-0.104|1.428|||MMRM|||||1.428|-0.104|0.0904
71907559|NCT02559206|143337016|SUPERIORITY|||||||0.07||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.0700
71907560|NCT02559206|143337017|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.992||||0.011|TWO_SIDED|95.0|0.228|1.756|||MMRM|||||1.756|0.228|0.0110
71907561|NCT02559206|143337017|SUPERIORITY||LS Mean Difference (Lin-Placebo)|0.161||||0.6801|TWO_SIDED|95.0|-0.604|0.925|||MMRM|||||0.925|-0.604|0.6801
71861410|NCT03784820|143237957|SUPERIORITY||LS mean difference|2.18||||0.46|TWO_SIDED|95.0|-3.59|7.95||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-3.59|0.46
71861411|NCT03784820|143237957|SUPERIORITY||LS mean difference|3.83||||0.27|TWO_SIDED|95.0|-2.94|10.6||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||10.60|-2.94|0.27
71861412|NCT03784820|143237958|SUPERIORITY||LS mean difference|1.06||||0.62|TWO_SIDED|95.0|-3.14|5.25||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||5.25|-3.14|0.62
71861413|NCT03784820|143237958|SUPERIORITY||LS mean difference|1.83||||0.54|TWO_SIDED|95.0|-4.07|7.73||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||7.73|-4.07|0.54
71861414|NCT03784820|143237959|SUPERIORITY||LS mean difference|4.8||||0.1|TWO_SIDED|95.0|-0.91|10.51||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||10.51|-0.91|0.10
71907562|NCT02559206|143337017|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.095||||0.8069|TWO_SIDED|95.0|-0.861|0.67|||MMRM|||||0.670|-0.861|0.8069
71681510|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.9|2.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19A||2.6|-1.9|< 0.001
71681511|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.0|1.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19F||1.9|-1.0|< 0.001
71861415|NCT03784820|143237959|SUPERIORITY||LS mean difference|1.08||||0.76|TWO_SIDED|95.0|-5.97|8.13||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.13|-5.97|0.76
71861416|NCT03784820|143237959|SUPERIORITY||LS mean difference|3.26||||0.23|TWO_SIDED|95.0|-2.03|8.55||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||8.55|-2.03|0.23
71861417|NCT03784820|143237959|SUPERIORITY||LS mean difference|-0.25||||0.94|TWO_SIDED|95.0|-6.63|6.14||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||6.14|-6.63|0.94
71861418|NCT03784820|143237959|SUPERIORITY||LS mean difference|-1.46||||0.68|TWO_SIDED|95.0|-8.38|5.46||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||5.46|-8.38|0.68
71861419|NCT03784820|143237959|SUPERIORITY||LS mean difference|-0.61||||0.89|TWO_SIDED|95.0|-9.06|7.84||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||7.84|-9.06|0.89
71861420|NCT03784820|143237960|SUPERIORITY||LS mean difference|-0.41||||0.91|TWO_SIDED|95.0|-7.61|6.79||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.79|-7.61|0.91
71861421|NCT03784820|143237960|SUPERIORITY||LS mean difference|4.72||||0.2|TWO_SIDED|95.0|-2.49|11.93||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||11.93|-2.49|0.20
71861422|NCT03784820|143237960|SUPERIORITY||LS mean difference|4.78||||0.14|TWO_SIDED|95.0|-1.63|11.2||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||11.20|-1.63|0.14
71861423|NCT03784820|143237960|SUPERIORITY||LS mean difference|3.86||||0.25|TWO_SIDED|95.0|-2.76|10.49||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||10.49|-2.76|0.25
71861424|NCT03784820|143237960|SUPERIORITY||LS mean difference|4.22||||0.14|TWO_SIDED|95.0|-1.45|9.89||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||9.89|-1.45|0.14
71861425|NCT03784820|143237960|SUPERIORITY||LS mean difference|3.15||||0.28|TWO_SIDED|95.0|-2.58|8.87||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||8.87|-2.58|0.28
71861426|NCT03784820|143237961|SUPERIORITY||LS mean difference|1.73||||0.85|TWO_SIDED|95.0|-16.73|20.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||20.19|-16.73|0.85
71861427|NCT03784820|143237961|SUPERIORITY||LS mean difference|7.94||||0.47|TWO_SIDED|95.0|-13.59|29.48||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||29.48|-13.59|0.47
71861428|NCT03784820|143237961|SUPERIORITY||LS mean difference|9.79||||0.37|TWO_SIDED|95.0|-11.5|31.08||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||31.08|-11.50|0.37
71861429|NCT03784820|143237961|SUPERIORITY||LS mean difference|0.36||||0.97|TWO_SIDED|95.0|-19.31|20.03||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||20.03|-19.31|0.97
71907563|NCT02559206|143337017|SUPERIORITY||LS Mean Difference (Lin-Placebo)|-0.246||||0.5275|TWO_SIDED|95.0|-1.011|0.519|||MMRM|||||0.519|-1.011|0.5275
71907564|NCT02559206|143337017|SUPERIORITY|||||||0.4201||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test|||||||0.4201
71907565|NCT02559206|143337018|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
71688723|NCT03749109|142892876|OTHER||Difference in LS mean|0.53||||0.49|TWO_SIDED|95.0|-0.99|2.05|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||2.05|-0.99|0.49
71861430|NCT03784820|143237961|SUPERIORITY||LS mean difference|-5.88||||0.52|TWO_SIDED|95.0|-23.85|12.09||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||12.09|-23.85|0.52
71861431|NCT03784820|143237961|SUPERIORITY||LS mean difference|-3.55||||0.68|TWO_SIDED|95.0|-20.33|13.23||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||13.23|-20.33|0.68
71861432|NCT03784820|143237962|SUPERIORITY||LS mean difference|-0.27||||0.91|TWO_SIDED|95.0|-5.02|4.47||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.47|-5.02|0.91
71861433|NCT03784820|143237962|SUPERIORITY||LS mean difference|4.73||||0.07|TWO_SIDED|95.0|-0.36|9.81||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||9.81|-0.36|0.07
71861434|NCT03784820|143237962|SUPERIORITY||LS mean difference|1.75||||0.65|TWO_SIDED|95.0|-5.73|9.23||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.23|-5.73|0.65
71861435|NCT03784820|143237962|SUPERIORITY||LS mean difference|-2.05||||0.52|TWO_SIDED|95.0|-8.21|4.12|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||4.12|-8.21|0.52
71861436|NCT03784820|143237962|SUPERIORITY||LS mean difference|-6.62||||0.07|TWO_SIDED|95.0|-13.74|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-13.74|0.07
71861437|NCT03784820|143237962|SUPERIORITY||LS mean difference|-6.64||||0.03|TWO_SIDED|95.0|-12.73|-0.56||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.56|-12.73|0.03
71861438|NCT03784820|143237963|SUPERIORITY||LS mean difference|0.88||||0.9|TWO_SIDED|95.0|-13.43|15.19||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||15.19|-13.43|0.90
71861439|NCT03784820|143237963|SUPERIORITY||LS mean difference|-0.64||||0.95|TWO_SIDED|95.0|-18.95|17.66||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||17.66|-18.95|0.95
71861440|NCT03784820|143237963|SUPERIORITY||LS mean difference|1.37||||0.89|TWO_SIDED|95.0|-17.17|19.9||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||19.90|-17.17|0.89
71861441|NCT03784820|143237963|SUPERIORITY||LS mean difference|5.81||||0.39|TWO_SIDED|95.0|-7.37|18.98|||Mixed Models Analysis|||Comparison of Partners at Post (T2)||18.98|-7.37|0.39
71861442|NCT03784820|143237963|SUPERIORITY||LS mean difference|6.29||||0.36|TWO_SIDED|95.0|-7.26|19.84||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||19.84|-7.26|0.36
71907566|NCT02559206|143337018|SUPERIORITY||Odds Ratio (OR)|1.39||||0.4399|TWO_SIDED|95.0|0.61|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.61|0.4399
71907567|NCT02559206|143337018|SUPERIORITY||Odds Ratio (OR)|1.27||||0.554|TWO_SIDED|95.0|0.57|2.85|||Cochran-Mantel-Haenszel|||||2.85|0.57|0.5540
71907568|NCT02559206|143337018|SUPERIORITY||Odds Ratio (OR)|2.39||||0.0262|TWO_SIDED|95.0|1.1|5.19|||Cochran-Mantel-Haenszel|||||5.19|1.10|0.0262
71907569|NCT02559206|143337018|SUPERIORITY|||||||0.0249||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.0249
71907570|NCT02559206|143337019|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1663|TWO_SIDED|95.0|0.79|3.7|||Cochran-Mantel-Haenszel|||||3.70|0.79|0.1663
71907571|NCT02559206|143337019|SUPERIORITY||Odds Ratio (OR)|1.13||||0.771|TWO_SIDED|95.0|0.49|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.49|0.7710
71907572|NCT02559206|143337019|SUPERIORITY||Odds Ratio (OR)|1.11||||0.8021|TWO_SIDED|95.0|0.48|2.58|||Cochran-Mantel-Haenszel|||||2.58|0.48|0.8021
71907573|NCT02559206|143337019|SUPERIORITY||Odds Ratio (OR)|0.89||||0.8011|TWO_SIDED|95.0|0.37|2.14|||Cochran-Mantel-Haenszel|||||2.14|0.37|0.8011
71907574|NCT02559206|143337019|SUPERIORITY|||||||0.8578||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test|||||||0.8578
71907575|NCT04656418|143337057|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical Testing H01) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
71907576|NCT04656418|143337058|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
71907577|NCT04656418|143337059|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
71907578|NCT04656418|143337059|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
71907579|NCT04656418|143337059|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
71907580|NCT04656418|143337060|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||6 Months of treatment||||<0.001
71907581|NCT04656418|143337060|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
71907582|NCT04656418|143337060|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
71907583|NCT04656418|143337061|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||First 3-months of treatment||||<0.001
71907584|NCT04656418|143337061|OTHER|Test for differences|||||<|0.001||||||Tested the differences between the active and placebo arms using a two-sided Wilcoxon test at alpha = 5%.|Two-sided Wilcoxon test|||Second 3-months of treatment||||<0.001
71907585|NCT04656418|143337062|OTHER|Test for differences|||||<|0.001||||||Compared the time-normalized number of HAE attacks in the active and placebo arms by using a two-sided Wilcoxon test (Hierarchical testing H02) at alpha = 5%.|Two-sided Wilcoxon test|||||||<0.001
71907586|NCT03097614|143337130|SUPERIORITY|||||||0.0001|TWO_SIDED||||||ANCOVA|||||||0.0001
71907587|NCT00751179|143337161|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
71907588|NCT00751179|143337162|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
71907589|NCT00751179|143337164|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
71907590|NCT00751179|143337166|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.||||<0.0001
71907591|NCT02678312|143337187|SUPERIORITY||Cox Proportional Hazard|1.0655||||0.7958|TWO_SIDED|95.0|0.6589|1.7232||The adjusted hazard ratio and the p-values are based on a Cox proportional hazard model, stratified by modified age group with treatment and NYHA/ROSS class group included as factor.|Cox Proportional Hazard|||||1.7232|0.6589|0.7958
71907592|NCT01784588|143337298|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Adjusted Difference in Percentages|-0.4|||||TWO_SIDED|90.0|-8.2|7.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||7.4|-8.2|
71907593|NCT01784588|143337298|NON_INFERIORITY|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Unadjusted Treatment Difference (%)|1.5|||||TWO_SIDED|90.0|-5.4|8.4||Non-inferiority was evaluated using a two-sided 90% confidence interval (CI) for the treatment difference (SIS minus TMUS). The CI was calculated based on the pooling of treatment differences across propensity score strata for a binary endpoint.||||Available Cases Only - Intent-to-Treat||8.4|-5.4|
71681512|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.8|||<|0.001|TWO_SIDED|95.0|-2.9|6.5|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 23F||6.5|-2.9|< 0.001
71681513|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-2.0|3.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 1||3.9|-2.0|< 0.001
71861443|NCT03784820|143237963|SUPERIORITY||LS mean difference|-1.55||||0.87|TWO_SIDED|95.0|-20.0|16.91||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||16.91|-20.00|0.87
71907594|NCT02988219|143337303|SUPERIORITY_OR_OTHER|||||||0.3861|||||||Chi-squared|||Bradycardia during surgery||||0.3861
71907595|NCT02988219|143337303|SUPERIORITY_OR_OTHER|||||||0.2591|||||||Chi-squared|||No bradycardia observed in the perioperative period||||0.2591
71907596|NCT02988219|143337304|SUPERIORITY_OR_OTHER|||||||0.597|||||||Chi-squared|||Arrhythmia before surgery||||0.597
71861444|NCT03784820|143237964|SUPERIORITY||LS mean difference|0.27||||0.84|TWO_SIDED|95.0|-2.29|2.83||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||2.83|-2.29|0.84
71861445|NCT03784820|143237964|SUPERIORITY||LS mean difference|-0.82||||0.57|TWO_SIDED|95.0|-3.66|2.01||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||2.01|-3.66|0.57
71861446|NCT03784820|143237964|SUPERIORITY||LS mean difference|0.6||||0.67|TWO_SIDED|95.0|-2.15|3.35||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.35|-2.15|0.67
71861447|NCT03784820|143237964|SUPERIORITY||LS mean difference|0.46||||0.63|TWO_SIDED|95.0|-1.43|2.35||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.35|-1.43|0.63
71861448|NCT03784820|143237964|SUPERIORITY||LS mean difference|1.44||||0.21|TWO_SIDED|95.0|-0.82|3.7||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||3.70|-0.82|0.21
71861449|NCT03784820|143237964|SUPERIORITY||LS mean difference|1.07||||0.34|TWO_SIDED|95.0|-1.14|3.28||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||3.28|-1.14|0.34
71861450|NCT03784820|143237965|SUPERIORITY||LS mean difference|-3.42||||0.5|TWO_SIDED|95.0|-13.36|6.52||Demand/Withdraw score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.52|-13.36|0.50
71681514|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|22.3|||<|0.001|TWO_SIDED|95.0|16.5|28.3|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 3||28.3|16.5|< 0.001
71681515|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.9|||<|0.001|TWO_SIDED|95.0|-1.4|5.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 4||5.4|-1.4|< 0.001
71861451|NCT03784820|143237965|SUPERIORITY||LS mean difference|-0.47||||0.89|TWO_SIDED|95.0|-7.49|6.54||Demand/Withdraw Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||6.54|-7.49|0.89
71861452|NCT03784820|143237965|SUPERIORITY||LS mean difference|-0.63||||0.86|TWO_SIDED|95.0|-7.56|6.3||Demand/Withdraw Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||6.30|-7.56|0.86
71861453|NCT03784820|143237965|SUPERIORITY||LS mean difference|2.55||||0.25|TWO_SIDED|95.0|-1.83|6.93||Constructive Communication Score: Comparison of Patients at Post (T2)|Mixed Models Analysis|||||6.93|-1.83|0.25
71861454|NCT03784820|143237965|SUPERIORITY||LS mean difference|2.05||||0.56|TWO_SIDED|95.0|-4.83|8.92||Constructive Communication Score: Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||8.92|-4.83|0.56
71861455|NCT03784820|143237965|SUPERIORITY||LS mean difference|3.13||||0.34|TWO_SIDED|95.0|-3.27|9.54||Constructive Communication Score: Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||9.54|-3.27|0.34
71861456|NCT03784820|143237965|SUPERIORITY||LS mean difference|-10.24||||0.02|TWO_SIDED|95.0|-19.05|-1.42||Demand/Withdraw score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||-1.42|-19.05|0.02
71861457|NCT03784820|143237965|SUPERIORITY||LS mean difference|-0.12||||0.98|TWO_SIDED|95.0|-8.18|7.95||Demand/Withdraw score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||7.95|-8.18|0.98
71861458|NCT03784820|143237965|SUPERIORITY||LS mean difference|-2.2||||0.59|TWO_SIDED|95.0|-10.1|5.7||Demand/Withdraw score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||5.70|-10.10|0.59
71861459|NCT03784820|143237965|SUPERIORITY||LS mean difference|2.41||||0.16|TWO_SIDED|95.0|-0.99|5.82||Constructive Communication Score: Comparison of Partners at Post (T2)|Mixed Models Analysis|||||5.82|-0.99|0.16
71861460|NCT03784820|143237965|SUPERIORITY||LS mean difference|3.94||||0.12|TWO_SIDED|95.0|-1.05|8.93||Constructive Communication Score: Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||8.93|-1.05|0.12
71861461|NCT03784820|143237965|SUPERIORITY||LS mean difference|2.26||||0.34|TWO_SIDED|95.0|-2.35|6.87||Constructive Communication Score: Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||6.87|-2.35|0.34
71861462|NCT03784820|143237966|SUPERIORITY||LS mean difference|0.09||||0.7|TWO_SIDED|95.0|-0.35|0.53||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||0.53|-0.35|0.70
71861463|NCT03784820|143237966|SUPERIORITY||LS mean difference|-0.03||||0.9|TWO_SIDED|95.0|-0.48|0.42||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||0.42|-0.48|0.90
71907597|NCT02988219|143337304|SUPERIORITY_OR_OTHER|||||||0.4|||||||Chi-squared|||arrhythmia during surgery||||0.4
71907598|NCT02988219|143337304|SUPERIORITY_OR_OTHER|||||||0.6544|||||||Chi-squared|||arrhythmia after surgery||||0.6544
71907599|NCT02988219|143337304|SUPERIORITY_OR_OTHER|||||||0.077|||||||Chi-squared|||long QTc \> 0.45s after surgery||||0.077
71907600|NCT02988219|143337304|SUPERIORITY_OR_OTHER|||||||0.0174|||||||Chi-squared|||long QTc \> 0.24 s in the perioperative time||||0.0174
71861464|NCT03784820|143237966|SUPERIORITY||LS mean difference|0.25||||0.38|TWO_SIDED|95.0|-0.31|0.82||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||0.82|-0.31|0.38
71861465|NCT03784820|143237967|SUPERIORITY||LS mean difference|-0.33||||0.89|TWO_SIDED|95.0|-5.1|4.43||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||4.43|-5.10|0.89
71861466|NCT03784820|143237967|SUPERIORITY||LS mean difference|0.45||||0.85|TWO_SIDED|95.0|-4.14|5.04||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||5.04|-4.14|0.85
71861467|NCT03784820|143237967|SUPERIORITY||LS mean difference|-0.85||||0.72|TWO_SIDED|95.0|-5.54|3.85||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||3.85|-5.54|0.72
71861468|NCT03784820|143237967|SUPERIORITY||LS mean difference|-3.05||||0.29|TWO_SIDED|95.0|-8.73|2.63||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.63|-8.73|0.29
71907601|NCT00065442|143337310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.775||||0.032|TWO_SIDED|95.0|0.614|0.979|||Regression, Cox|Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.|sipuleucel-T/placebo|||0.979|0.614|0.032
71681516|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 5||2.7|-4.1|< 0.001
71681517|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|TWO_SIDED|95.0|-4.2|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6A||2.8|-4.2|< 0.001
71907602|NCT00065442|143337310|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.766||||0.023|TWO_SIDED|95.0|0.608|0.965|||Log Rank|Stratified by randomization strata.|Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)|||0.965|0.608|0.023
71907603|NCT00065442|143337311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.951||||0.628|TWO_SIDED|95.0|0.773|1.169|||Log Rank|Stratified by randomization strata|Cox regression model with treatment as the independent variable, stratified by randomization strata|||1.169|0.773|0.628
71907604|NCT01764256|143337312|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.44|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event (related or unrelated)||||0.44
71907605|NCT01764256|143337312|EQUIVALENCE|Definition of equivalence: p\<0.05||||||0.7446|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event: potentially related||||0.7446
71907606|NCT01764256|143337313|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.5694|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.5694
71861469|NCT03784820|143237967|SUPERIORITY||LS mean difference|-4.69||||0.08|TWO_SIDED|95.0|-9.9|0.51||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||0.51|-9.90|0.08
71861470|NCT03784820|143237967|SUPERIORITY||LS mean difference|-3.29||||0.19|TWO_SIDED|95.0|-8.23|1.65||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||1.65|-8.23|0.19
71688724|NCT03749109|142892876|OTHER||Difference in LS mean|-0.01||||0.99|TWO_SIDED|95.0|-1.32|1.3|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 1||1.30|-1.32|0.99
71861471|NCT03784820|143237968|SUPERIORITY||LS mean difference|-1.2||||0.41|TWO_SIDED|95.0|-4.08|1.67||Comparison of Patients at Post (T2)|Mixed Models Analysis|||||1.67|-4.08|0.41
71861472|NCT03784820|143237968|SUPERIORITY||LS mean difference|0.33||||0.84|TWO_SIDED|95.0|-2.87|3.54||Comparison of Patients at 3 Month Fup (T3)|Mixed Models Analysis|||||3.54|-2.87|0.84
71861473|NCT03784820|143237968|SUPERIORITY||LS mean difference|-1.21||||0.5|TWO_SIDED|95.0|-4.76|2.34||Comparison of Patients at 6 Month Fup (T4)|Mixed Models Analysis|||||2.34|-4.76|0.50
71861474|NCT03784820|143237968|SUPERIORITY||LS mean difference|-1.09||||0.52|TWO_SIDED|95.0|-4.43|2.24||Comparison of Partners at Post (T2)|Mixed Models Analysis|||||2.24|-4.43|0.52
71861475|NCT03784820|143237968|SUPERIORITY||LS mean difference|-1.38||||0.3|TWO_SIDED|95.0|-3.96|1.21||Comparison of Partners at 3 Month Fup (T3)|Mixed Models Analysis|||||1.21|-3.96|0.30
71861476|NCT03784820|143237968|SUPERIORITY||LS mean difference|-2.52||||0.03|TWO_SIDED|95.0|-4.78|-0.25||Comparison of Partners at 6 Month Fup (T4)|Mixed Models Analysis|||||-0.25|-4.78|0.03
71861477|NCT03784820|143237969|SUPERIORITY||Mean Difference (Final Values)|0.53||||0.79|TWO_SIDED|95.0|-3.66|4.72||Comparison of Patients at Post (T2)|t-test, 2 sided|||||4.72|-3.66|0.79
71861478|NCT00658606|143237974|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||||||0.032
71861479|NCT00658606|143237975|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||No adjustments were made to multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.037
71861480|NCT00658606|143237976|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to 'Change from Baseline'||||0.001
71861481|NCT00658606|143237977|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.382
71861482|NCT00658606|143237978|SUPERIORITY_OR_OTHER|||||||0.052||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.052
71907607|NCT01764256|143337313|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1.0000
71907608|NCT01764256|143337313|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
71907609|NCT01764256|143337314|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||0.6004|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||0.6004
71907610|NCT01764256|143337314|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)||||1
71907611|NCT01764256|143337314|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.00
71907612|NCT01764256|143337315|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
71907613|NCT01764256|143337315|EQUIVALENCE|Equivalence defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
71907614|NCT01764256|143337315|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
71907615|NCT01764256|143337316|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)||||1.0000
71907616|NCT01764256|143337316|EQUIVALENCE|Equivalence was defined as p\<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)||||1.0000
71907617|NCT01764256|143337316|EQUIVALENCE|Equivalence was defined as p\<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)||||1.0000
71907618|NCT02466412|143337347|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|63.9326|||||TWO_SIDED|95.0|49.6045|82.3991|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.||82.3991|49.6045|
71907619|NCT02466412|143337348|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|60.0052|||||TWO_SIDED|95.0|44.9517|80.0997|||ANOVA|The model included terms for sequence, subject nested within sequence, period, and product as fixed effect factors.|"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.||80.0997|44.9517|
71907620|NCT02553317|143337349|SUPERIORITY||||||=|0.0099||||||The resulting p-value was compared with a significance level of 5%.|Log Rank|||Time to platelet count response in the caplacizumab arm and placebo arm was compared by conducting a two-sided stratified log-rank test based on a KM analysis, with severity of neurological involvement (according to the Glasgow coma scale \[GCS\] category, stratification factor used in randomization: ≤12 / 13-15) as stratification factor.||||= 0.0099
71907621|NCT02553317|143337349|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|1.095|2.195|||||The HR was estimated from a Cox proportional Hazards regression model.|Time to platelet count response was analyzed using a Cox proportional hazards regression model with time to platelet count response as dependent variable, and treatment group and GCS category as independent variables. The hazard (or platelet count normalization rate) ratio from the Cox model was reported along with 95% CI.||2.195|1.095|
71907622|NCT02553317|143337350|SUPERIORITY||||||<|0.0001||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was conducted with adjustment for GCS category (stratification factor used in randomization).||||< 0.0001
71907623|NCT02553317|143337351|SUPERIORITY||||||=|0.0004||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0004
71907624|NCT02553317|143337352|SUPERIORITY||||||=|0.0572||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).||||= 0.0572
71907625|NCT02219087|143337363|SUPERIORITY_OR_OTHER|||||||0.137|||||||t-test, 2 sided|||||||0.137
71907626|NCT02219087|143337364|SUPERIORITY_OR_OTHER|||||||0.343|||||||t-test, 2 sided|||||||0.343
71681518|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|TWO_SIDED|95.0|-3.7|5.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6B||5.6|-3.7|< 0.001
71907627|NCT02219087|143337365|SUPERIORITY_OR_OTHER|||||||0.208|||||||t-test, 2 sided|||||||0.208
71907628|NCT02219087|143337366|SUPERIORITY_OR_OTHER|||||||0.385|||||||t-test, 2 sided|||||||0.385
71907629|NCT02219087|143337367|SUPERIORITY_OR_OTHER|||||||0.843|||||||Chi-squared|||||||0.843
71907630|NCT02219087|143337368|SUPERIORITY_OR_OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
71907631|NCT03956225|143337379|NON_INFERIORITY|Noninferiority in change from baseline in MGS was declared if the lower confidence limit (LCL) was greater than -5.|Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.07|||ONE_SIDED|95.0|-2.2||||Mixed effects repeated measures||Standard Error of the Least Squares Mean is presented. Least squares mean difference (iLux minus LipiFlow). Lower Confidence Limit is presented.||||-2.2|
71907632|NCT04093258|143337380|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.33|6.85|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test/Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||6.85|0.33|
71907633|NCT04093258|143337381|NON_INFERIORITY|Non-inferiority will be concluded if the lower limit is above 0.67. Superiority will be concluded if the lower limit is above 1.0.|Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.1|1.19|||Generalized Linear Mixed Model Analysis|Finite-sample corrected Akaike's Information Criterion|Odds ratio was calculated as Test over Control|"The proportion of response (1) was analyzed using a generalized linear mixed model with a binary distribution and logit link function for all questions."||1.19|0.10|
71681519|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|TWO_SIDED|95.0|-1.7|2.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 7F||2.4|-1.7|< 0.001
71688725|NCT03749109|142892876|OTHER||Difference in LS mean|0.17||||0.83|TWO_SIDED|95.0|-1.38|1.71|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||1.71|-1.38|0.83
71861483|NCT00658606|143237979|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'||||0.026
71861484|NCT00658606|143237980|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'PASI 90 = Yes'||||0.147
71861485|NCT00658606|143237981|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.566
71861486|NCT00658606|143237982|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.001
71861487|NCT00658606|143237983|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||No adjustments were made for multiple comparisons.|Log Rank|||||||0.007
71861488|NCT00658606|143237984|SUPERIORITY_OR_OTHER|||||||0.539||95.0||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'||||0.539
71861489|NCT03170518|143237990|SUPERIORITY|Imputed datasets were analyzed using analysis of covariance (ANCOVA) with terms for treatment, stratification factors (antihyperglycemic agent background and age group), and baseline HbA1c.|Least square mean difference|-0.76|||=|0.002|TWO_SIDED|95.0|-1.25|-0.27|||ANCOVA|||||-0.27|-1.25|= 0.002
71861490|NCT03023423|143238045|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.03|1.92||||||||1.92|0.03|
71861491|NCT01227616|143238060|NON_INFERIORITY|The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non-inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.|Mean Difference (Final Values)|0.5|||<|0.05|TWO_SIDED||||||ANCOVA|Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.||||||<0.05
71861492|NCT01431950|143238063|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077||||||95.0|-0.039|0.192||||||||0.192|-0.039|
71861493|NCT02559310|143238068|NON_INFERIORITY|Non-inferiority Margin = 12.5%.|Treatment Difference (Lef - Mox)|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic.|||2.8|-8.5|
71688726|NCT03749109|142892876|OTHER||Difference in LS mean|-0.74||||0.28|TWO_SIDED|95.0|-2.11|0.63|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 3||0.63|-2.11|0.28
71861494|NCT02559310|143238069|NON_INFERIORITY|Non-inferiority Margin = 10%.|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-8.9|3.9|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.9|-8.9|
71861495|NCT02559310|143238069|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.6|||||TWO_SIDED|95.0|-9.2|4.1|||||Difference in percentage of Success for IACR at test of cure visit. CI computed using continuity-corrected Z-statistic.|||4.1|-9.2|
71861496|NCT02559310|143238070|NON_INFERIORITY|Non-Inferiority Margin = 10%.|Treatment Difference|-2.5|||||TWO_SIDED|95.0|-8.4|3.4|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \[Y vs. N\] and PORT risk class \[III vs. IV/V\], using CMH stratum weights.|||3.4|-8.4|
71861497|NCT02559310|143238070|NON_INFERIORITY|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.5|||||TWO_SIDED|95.0|-8.7|3.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic|||3.7|-8.7|
71861498|NCT02726945|143238113|SUPERIORITY|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.023
71861499|NCT02726945|143238113|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."||||0.043
71861500|NCT03728985|143238114|NON_INFERIORITY|Performance Goal 80%|Absolute Percentage with Success|77.5||||0.5908|TWO_SIDED|90.0|69.6|84.1|||Fisher Exact||The lower estimated confidence interval above the Performance Goal of 80% would be considered success.|||84.1|69.6|0.5908
71861501|NCT03728985|143238115|NON_INFERIORITY|Performance Goal 68%|Percentage with Success|70.6||||0.7017|TWO_SIDED|90.0|61.4|78.7|||Fisher Exact|||||78.7|61.4|0.7017
71861502|NCT02783573|143238194|SUPERIORITY||LS Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.64||0.129|TWO_SIDED|95.0|-0.752|5.776|||Mixed Models Analysis|||||5.776|-0.752|0.129
71861503|NCT02783573|143238194|SUPERIORITY||LS Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|1.76||0.903|TWO_SIDED|95.0|-3.725|3.296|||Mixed Models Analysis|||||3.296|-3.725|0.903
71861504|NCT02783573|143238195|SUPERIORITY||LS Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|1.78||0.1|TWO_SIDED|95.0|-6.488|0.58|||Mixed Models Analysis|||||0.580|-6.488|0.100
71861505|NCT02783573|143238195|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|1.86||0.092|TWO_SIDED|95.0|-6.876|0.525|||Mixed Models Analysis|||||0.525|-6.876|0.092
71861506|NCT02783573|143238196|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|1.14||0.285|TWO_SIDED|95.0|-1.045|3.499|||Mixed Models Analysis|||||3.499|-1.045|0.285
71861507|NCT02783573|143238196|SUPERIORITY||LS Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.19||0.661|TWO_SIDED|95.0|-2.889|1.843|||Mixed Models Analysis|||||1.843|-2.889|0.661
71861508|NCT02783573|143238197|SUPERIORITY||LS Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|2.69||0.079|TWO_SIDED|95.0|-10.103|0.56|||Mixed Models Analysis|||||0.56|-10.103|0.079
71907634|NCT04093258|143337382|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least square mean difference|-5.98|STANDARD_ERROR_OF_MEAN|3.202|||TWO_SIDED|95.0|-12.48|0.52|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|||0.52|-12.48|
71907635|NCT00594204|143337383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.78|||<|0.0001||95.0|2.97|7.68||p-values are obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||7.68|2.97|<0.0001
71907636|NCT00594204|143337384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0|||<|0.0001||95.0|3.3|7.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 12||7.5|3.3|<0.0001
71907637|NCT00594204|143337384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.3|||<|0.0001||95.0|2.8|6.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 24||6.5|2.8|<0.0001
71907638|NCT00594204|143337385|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.76|||<|0.0001||95.0|3.74|8.88|||Regression, Logistic|p-value are obtained from a logistic regression model including the main effects of treatment and country|Odds Ratios obtained from a logistic regression model including the main effects of treatment and country|||8.88|3.74|<0.0001
71907639|NCT01401465|143337386|SUPERIORITY_OR_OTHER||Slope|88.235|||<|0.0001||||||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Two-sided Signed Rank Test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Total Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. For the primary endpoint of the Total Preference Score, assuming an SD of 40, a sample size of 155 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.025 two-sided significance level.||||<0.0001
71907640|NCT01401465|143337387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.9|||<|0.0001|TWO_SIDED|95.0|11.22|16.58||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline.||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||16.58|11.22|<0.0001
71907641|NCT01401465|143337387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|2.2|7.56||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.||7.56|2.20|<0.0001
71907642|NCT01401465|143337388|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|88.889|||<|0.0001||||||If both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|Two-sided signed-rank test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Treatment Process Composite Preference Score = 50. Values \> 50 indicate preference for ciclesonide, while values \< 50 indicate preference for mometasone. Assuming an SD of 40, as observed in Study 060-301, a sample size of 128 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.05 two-sided significant level||||<0.0001
71907643|NCT01401465|143337389|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CI of the LS mean difference of ciclesonide nasal aerosol minus mometasone aqueous nasal spray was calculated from the ANCOVA model, and the upper bound of the CI was compared to the non-inferiority margin of 0.5. Non-inferiority was declared if the upper bound of the 95% CI of this difference was \< 0.5.|Difference in LS Means|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||f both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|ANCOVA|Site, treatment, period, treatment sequence as fixed effects, subject nested within sequence as a random effect, and baseline rTNSS as a covariate.|Ciclesonide 74 mcg minus Mometasone 200 mcg|The null hypothesis is that the change from baseline in rTNSS for ciclesonide 74 mcg nasal aerosol minus the change from baseline in rTNSS for mometasone AQ 200 mcg is greater than 0.5.||0.1|-0.3|
71907644|NCT01115738|143337421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.24||||0.188|TWO_SIDED|95.0|-10.98|55.47||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||55.47|-10.98|0.188
71907645|NCT01115738|143337421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.93||||0.809|TWO_SIDED|95.0|-28.2|36.07||P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||36.07|-28.20|0.809
71907646|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93||||0.37|TWO_SIDED|95.0|-20.26|54.12||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||54.12|-20.26|0.370
71681520|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|TWO_SIDED|95.0|-1.1|5.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 9V||5.2|-1.1|< 0.001
71861509|NCT02783573|143238197|SUPERIORITY||LS Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|2.82||0.486|TWO_SIDED|95.0|-7.573|3.62|||Mixed Models Analysis|||||3.62|-7.573|0.486
71861510|NCT02783573|143238198|SUPERIORITY||LS Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.57||0.663|TWO_SIDED|95.0|-0.89|1.391|||Mixed Models Analysis|||||1.391|-0.890|0.663
71861511|NCT02783573|143238198|SUPERIORITY||LS Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.6||0.717|TWO_SIDED|95.0|-1.423|0.983|||Mixed Models Analysis|||||0.983|-1.423|0.717
71861512|NCT02783573|143238200|SUPERIORITY||LS Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|2.34||0.899|TWO_SIDED|95.0|-4.297|4.889|||Mixed Models Analysis|||||4.889|-4.297|0.899
71861513|NCT02783573|143238200|SUPERIORITY||LS Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|2.16||0.164|TWO_SIDED|95.0|-7.267|1.238|||Mixed Models Analysis|||||1.238|-7.267|0.164
71907647|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.89||||0.052|TWO_SIDED|95.0|-0.29|72.06||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||72.06|-0.29|0.052
71907648|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.703|TWO_SIDED|95.0|-39.55|58.45||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||58.45|-39.55|0.703
71907649|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.45||||0.823|TWO_SIDED|95.0|-42.53|53.44||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||53.44|-42.53|0.823
71907650|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.69||||0.054|TWO_SIDED|95.0|-0.47|57.84||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||57.84|-0.47|0.054
71907651|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.436|TWO_SIDED|95.0|-17.29|39.9||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||39.90|-17.29|0.436
71907652|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.87||||0.463|TWO_SIDED|95.0|-14.96|32.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||32.71|-14.96|0.463
71907653|NCT01115738|143337422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.34||||0.777|TWO_SIDED|95.0|-26.62|19.94||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||19.94|-26.62|0.777
71907654|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31||||0.505|TWO_SIDED|95.0|-13.1|6.48||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||6.48|-13.10|0.505
71861514|NCT02783573|143238201|SUPERIORITY||LS Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.82||0.126|TWO_SIDED|95.0|-2.891|0.362|||Mixed Models Analysis|||||0.362|-2.891|0.126
71861515|NCT02783573|143238201|SUPERIORITY||LS Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.86||0.862|TWO_SIDED|95.0|-1.867|1.566|||Mixed Models Analysis|||||1.566|-1.867|0.862
71861516|NCT02783573|143238202|SUPERIORITY||LS Mean Difference (Final Values)|-37.55|STANDARD_ERROR_OF_MEAN|37.49||0.343|TWO_SIDED|95.0|-122.35|47.26|||ANCOVA|||||47.26|-122.35|0.343
71861517|NCT02783573|143238202|SUPERIORITY||LS Mean Difference (Final Values)|-40.72|STANDARD_ERROR_OF_MEAN|35.12||0.276|TWO_SIDED|95.0|-120.17|38.73|||ANCOVA|||||38.73|-120.17|0.276
71861518|NCT02783573|143238203|SUPERIORITY||LS Mean Difference (Final Values)|-61.94|STANDARD_ERROR_OF_MEAN|31.3||0.079|TWO_SIDED|95.0|-132.75|8.87|||ANCOVA|||||8.87|-132.75|0.079
71861519|NCT02783573|143238203|SUPERIORITY||LS Mean Difference (Final Values)|-34.15|STANDARD_ERROR_OF_MEAN|31.27||0.303|TWO_SIDED|95.0|-104.88|36.59|||ANCOVA|||||36.59|-104.88|0.303
71861520|NCT02783573|143238204|SUPERIORITY||LS Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|14.29||0.283|TWO_SIDED|95.0|-16.015|48.659|||ANCOVA|||||48.659|-16.015|0.283
71861521|NCT02783573|143238204|SUPERIORITY||LS Mean Difference (Final Values)|-13.05|STANDARD_ERROR_OF_MEAN|13.21||0.349|TWO_SIDED|95.0|-42.929|16.82|||ANCOVA|||||16.820|-42.929|0.349
71861522|NCT02783573|143238205|SUPERIORITY||LS Mean Difference (Final Values)|1.59|STANDARD_ERROR_OF_MEAN|2.23||0.494|TWO_SIDED|95.0|-3.457|6.64|||ANCOVA|||||6.640|-3.457|0.494
71861523|NCT02783573|143238205|SUPERIORITY||LS Mean Difference (Final Values)|-2.13|STANDARD_ERROR_OF_MEAN|2.04||0.323|TWO_SIDED|95.0|-6.743|2.481|||ANCOVA|||||2.481|-6.743|0.323
71681521|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.2|||<|0.001|TWO_SIDED|95.0|-2.8|3.1|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 14||3.1|-2.8|< 0.001
71861524|NCT02783573|143238206|SUPERIORITY||LS Mean Difference (Final Values)|2.22|STANDARD_ERROR_OF_MEAN|13.76||0.873|TWO_SIDED|95.0|-26.569|31.017|||ANCOVA|||||31.017|-26.569|0.873
71907655|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.23||||0.278|TWO_SIDED|95.0|-14.74|4.27||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.27|-14.74|0.278
71861525|NCT02783573|143238206|SUPERIORITY||LS Mean Difference (Final Values)|-15.2|STANDARD_ERROR_OF_MEAN|15.43||0.337|TWO_SIDED|95.0|-47.488|17.096|||ANCOVA|||||17.096|-47.488|0.337
71861526|NCT02783573|143238207|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.927|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.927
71861527|NCT02783573|143238207|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.93|TWO_SIDED|95.0|-0.015|0.017|||ANCOVA|||||0.017|-0.015|0.930
71861528|NCT02783573|143238208|SUPERIORITY||LS Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|1.06||0.127|TWO_SIDED|95.0|-3.708|0.464|||ANCOVA|||||0.464|-3.708|0.127
71861529|NCT02783573|143238208|SUPERIORITY||LS Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.06||0.004|TWO_SIDED|95.0|-5.172|-0.991|||ANCOVA|||||-0.991|-5.172|0.004
71861530|NCT00159263|143238211|OTHER|Friedman ANOVA followed Dunn's pairwise comparisons||||||0.04|||||||ANOVA|||||||0.04
71907656|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.749|TWO_SIDED|95.0|-19.44|14.02||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||14.02|-19.44|0.749
71861531|NCT00159263|143238212|OTHER|Friedman Anova||||||0.01|||||||ANOVA|||||||0.01
71907657|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.89|TWO_SIDED|95.0|-15.24|17.53||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||17.53|-15.24|0.890
71681522|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.6|||<|0.001|TWO_SIDED|95.0|-0.3|5.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 18C||5.9|-0.3|< 0.001
71861532|NCT00159263|143238213|OTHER|Friedman Anova||||||0.04|||||||ANOVA|||||||0.04
71861533|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|3.4||||95.0|17.2|17.3||||||IOP 1 year (n=11602)||17.3|17.2|
71861534|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|2.9||||95.0|16.8|17.0||||||IOP 1 year (n=4450)||17.0|16.8|
71861535|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.3|STANDARD_DEVIATION|2.2||||95.0|17.1|17.5||||||IOP 1 year (n=357)||17.5|17.1|
71861536|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.2||||95.0|16.4|17.3||||||IOP 1 year (n=220)||17.3|16.4|
71861537|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.6|STANDARD_DEVIATION|4.1||||95.0|17.5|17.8||||||IOP 1 year (n=3277)||17.8|17.5|
71861538|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|17.0|17.1||||||IOP 2 years (n=8051)||17.1|17.0|
71861539|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|2.9||||95.0|16.7|16.9||||||IOP 2 years (n=2808)||16.9|16.7|
71861540|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.2|STANDARD_DEVIATION|1.8||||95.0|17.0|17.5||||||IOP 2 years (n=175)||17.5|17.0|
71861541|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.6|STANDARD_DEVIATION|2.8||||95.0|15.9|17.2||||||IOP 2 years (n=83)||17.2|15.9|
71861542|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.1|STANDARD_DEVIATION|3.7||||95.0|16.9|17.2||||||IOP 2 years (n=2002)||17.2|16.9|
71861543|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.0|STANDARD_DEVIATION|3.4||||95.0|16.9|17.1||||||IOP 3 years (n=5469)||17.1|16.9|
71861544|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.8|STANDARD_DEVIATION|3.2||||95.0|16.7|17.0||||||IOP 3 years (n=1932)||17.0|16.7|
71861545|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|17.5|STANDARD_DEVIATION|2.5||||95.0|16.9|18.1||||||IOP 3 years (n=64)||18.1|16.9|
71861546|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.5|STANDARD_DEVIATION|2.8||||95.0|15.7|17.4||||||IOP 3 years (n=44)||17.4|15.7|
71861547|NCT01012245|143238214|SUPERIORITY_OR_OTHER_LEGACY||Mean value|16.9|STANDARD_DEVIATION|3.6||||95.0|16.7|17.1||||||IOP 3 years (n=1251)||17.1|16.7|
71861548|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 1 year (n=11966)||0.47|0.46|
71861549|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.44|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Vertical C/D ratio 1 year (n=4944)||0.44|0.43|
71861550|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.19||||95.0|0.35|0.43||||||Vertical C/D ratio 1 year (n=88)||0.43|0.35|
71861551|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.24||||95.0|0.47|0.53||||||Vertical C/D ratio 1 year (n=241)||0.53|0.47|
71861552|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Vertical C/D ratio 1 year (n=2949)||0.52|0.50|
71861553|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.46|STANDARD_DEVIATION|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 2 years (n=8783)||0.47|0.46|
71861554|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.23||||95.0|0.42|0.44||||||Vertical C/D ratio 2 years (n=3396)||0.44|0.42|
71861555|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.39|STANDARD_DEVIATION|0.16||||95.0|0.33|0.45||||||Vertical C/D ratio 2 years (n=31)||0.45|0.33|
71861556|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.24||||95.0|0.44|0.54||||||Vertical C/D ratio 2 years (n=95)||0.54|0.44|
71861557|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.53||||||Vertical C/D ratio 2 years (n=1934)||0.53|0.50|
71861558|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.24||||95.0|0.44|0.45||||||Vertical C/D ratio 3 years (n=6344)||0.45|0.44|
71681523|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|TWO_SIDED|95.0|-2.5|2.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19A||2.2|-2.5|< 0.001
71861559|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.22||||95.0|0.41|0.43||||||Vertical C/D ratio 3 years (n=2372)||0.43|0.41|
71861560|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.33|STANDARD_DEVIATION|0.14||||95.0|0.27|0.39||||||Vertical C/D ratio 3 years (n=25)||0.39|0.27|
71861561|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.47|STANDARD_DEVIATION|0.18||||95.0|0.41|0.53||||||Vertical C/D ratio 3 years (n=36)||0.53|0.41|
71861562|NCT01012245|143238216|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.26||||95.0|0.48|0.51||||||Vertical C/D ratio 3 years (n=1283)||0.51|0.48|
71688727|NCT03749109|142892876|OTHER||Difference in LS mean|0.75||||0.26|TWO_SIDED|95.0|-0.57|2.07|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||2.07|-0.57|0.26
71861563|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.45|0.46||||||Horizontal C/D ratio 1 year (n=11433)||0.46|0.45|
71861564|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.42|STANDARD_DEVIATION|0.23||||95.0|0.42|0.43||||||Horizontal C/D ratio 1 year (n=4810)||0.43|0.42|
71861565|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.37|STANDARD_DEVIATION|0.19||||95.0|0.33|0.42||||||Horizontal C/D ratio 1 year (n=87)||0.42|0.33|
71861566|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.47|0.53||||||Horizontal C/D ratio 1 year (n=232)||0.53|0.47|
71861567|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.5|0.52||||||Horizontal C/D ratio 1 year (n=2703)||0.52|0.50|
71861568|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.45|STANDARD_DEVIATION|0.25||||95.0|0.44|0.45||||||Horizontal C/D ratio 2 years (n=8427)||0.45|0.44|
71861569|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.41|STANDARD_DEVIATION|0.23||||95.0|0.4|0.42||||||Horizontal C/D ratio 2 years (n=3276)||0.42|0.40|
71861570|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.38|STANDARD_DEVIATION|0.19||||95.0|0.31|0.45||||||Horizontal C/D ratio 2 years (n=31)||0.45|0.31|
71861571|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.5|STANDARD_DEVIATION|0.25||||95.0|0.45|0.56||||||Horizontal C/D ratio 2 years (n=92)||0.56|0.45|
71861572|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.51|STANDARD_DEVIATION|0.27||||95.0|0.49|0.52||||||Horizontal C/D ratio 2 years (n=1812)||0.52|0.49|
71861573|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.43|STANDARD_DEVIATION|0.24||||95.0|0.43|0.44||||||Horizontal C/D ratio 3 years (n=6102)||0.44|0.43|
71861574|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.4|STANDARD_DEVIATION|0.22||||95.0|0.39|0.41||||||Horizontal C/D ratio 3 years (n=2289)||0.41|0.39|
71861575|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.31|STANDARD_DEVIATION|0.15||||95.0|0.25|0.38||||||Horizontal C/D ratio 3 years (n=25)||0.38|0.25|
71861576|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.49|STANDARD_DEVIATION|0.21||||95.0|0.42|0.57||||||Horizontal C/D ratio 3 years (n=35)||0.57|0.42|
71861577|NCT01012245|143238217|SUPERIORITY_OR_OTHER_LEGACY||Mean value|0.48|STANDARD_DEVIATION|0.26||||95.0|0.47|0.5||||||Horizontal C/D ratio 3 years (n=1204)||0.50|0.47|
71861578|NCT01475305|143238260|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|||2.05|0.00|
71861579|NCT01475305|143238261|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by quantitative real-time RT-PCR||6.24|0.16|
71861580|NCT01475305|143238261|SUPERIORITY_OR_OTHER||Relative Risk|0.0|||||TWO_SIDED|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by DFA||2.05|0.00|
71861581|NCT01475305|143238261|SUPERIORITY_OR_OTHER||Relative Risk|1.0|||||TWO_SIDED|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by Any Method||6.24|0.16|
71861582|NCT00132678|143238284|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.001||95.0|0.27|0.59|||Log Rank|Adjusting for country|RISPERDAL CONSTA hazard in numerator, placebo hazard in denominator.|||0.59|0.27|<0.001
71861583|NCT00132678|143238285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.09|<|0.001||95.0|-8.08|-3.79|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-3.79|-8.08|<0.001
71861584|NCT00132678|143238286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.87||0.02||95.0|-3.75|-0.32|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.|||-0.32|-3.75|0.020
71861585|NCT05146206|143238303|OTHER||||||<|0.001|||||||ANOVA|||||||<.001
71861586|NCT05146206|143238304|OTHER||||||<|0.001|||||||MANOVA|||||||<0.001
71861587|NCT02577003|143238305|SUPERIORITY||Difference in least squares means|-0.77|||<|0.001|TWO_SIDED|95.0|-0.98|-0.57|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-0.57|-0.98|<0.001
71861588|NCT02577003|143238308|SUPERIORITY||Difference in least squares means|-28.1|||<|0.001|TWO_SIDED|95.0|-34.8|-21.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-21.5|-34.8|<0.001
71861589|NCT02577003|143238309|SUPERIORITY||Difference in least squares means|-48.5|||<|0.001|TWO_SIDED|95.0|-59.6|-37.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-37.5|-59.6|<0.001
71861590|NCT02577003|143238310|SUPERIORITY||Difference in least squares means|-84.6|||<|0.001|TWO_SIDED|95.0|-102.6|-66.6|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-66.6|-102.6|<0.001
71861591|NCT02577003|143238311|SUPERIORITY||Difference in least squares means|-1.8|||<|0.001|TWO_SIDED|95.0|-2.5|-1.1|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.||||-1.1|-2.5|<0.001
71861592|NCT01677299|143238315|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-22.5|||<|0.05|TWO_SIDED|95.0|-37.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment A.||||-8|-37|<0.05
71861593|NCT01677299|143238315|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-20.0|||<|0.05|TWO_SIDED|95.0|-30.0|-9.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment B.||||-9|-30|<0.05
71861594|NCT01677299|143238315|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-16.0|||<|0.05|TWO_SIDED|95.0|-24.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment C.||||-8|-24|<0.05
71688728|NCT03749109|142892876|OTHER||Difference in LS mean|0.91||||0.19|TWO_SIDED|95.0|-0.49|2.31|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 1||2.31|-0.49|0.19
71861595|NCT01677299|143238315|SUPERIORITY_OR_OTHER||LS mean diff (Day 5 - Baseline)|-21.0|||<|0.05|TWO_SIDED|95.0|-31.0|-11.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment D.||||-11|-31|<0.05
71861596|NCT01677299|143238316|SUPERIORITY_OR_OTHER||Geometric LS mean ration|1.6|||<|0.05|TWO_SIDED|95.0|1.4|1.9|||Mixed Models Analysis|||||1.9|1.4|<0.05
71861597|NCT01677299|143238316|SUPERIORITY_OR_OTHER||Geo LSmean ratio of (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
71861598|NCT01677299|143238316|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.7|||<|0.05|TWO_SIDED|95.0|1.4|2.0|||Mixed Models Analysis|||||2.0|1.4|<0.05
71861599|NCT01677299|143238316|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.9|||<|0.05|TWO_SIDED|95.0|1.5|2.3|||Mixed Models Analysis|||||2.3|1.5|<0.05
71861600|NCT01677299|143238317|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.8|||Mixed Models Analysis|||||1.8|1.4|<0.05
71861601|NCT01677299|143238317|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.4|||<|0.05|TWO_SIDED|95.0|1.2|1.6|||Mixed Models Analysis|||||1.6|1.2|<0.05
71861602|NCT01677299|143238317|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.3|1.6|||Mixed Models Analysis|||||1.6|1.3|<0.05
71861603|NCT01677299|143238317|SUPERIORITY_OR_OTHER||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|TWO_SIDED|95.0|1.4|1.6|||Mixed Models Analysis|||||1.6|1.4|<0.05
71861604|NCT00559377|143238322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.42|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO Hypoxic Volume to overall survival||||.42
71861605|NCT00559377|143238322|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.87|TWO_SIDED||||||Regression, Cox|||This outcome is for comparing FMISO T:Bmax to overall survival||||.87
71861606|NCT00559377|143238323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.58|TWO_SIDED||||||Regression, Cox|||This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival||||.58
71861607|NCT00559377|143238323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.98|TWO_SIDED||||||Regression, Cox|||This outcome is for comarison of FMISO T:Bmax to progression-free survival||||.98
71861608|NCT00559377|143238324|SUPERIORITY_OR_OTHER||Spearman Correlation|0.004|||<|0.05|TWO_SIDED||||||Spearman Correlation|||The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.||||<0.05
71861609|NCT00940875|143238328|SUPERIORITY_OR_OTHER||Difference in Response Rates|-3.3|||||TWO_SIDED|95.0|-17.5|10.9|||||The 95% CI for the difference of 2 rates was estimated using the Hauck-Anderson method.|||10.9|-17.5|
71861610|NCT00940875|143238329|SUPERIORITY_OR_OTHER|||||||0.4798|TWO_SIDED||||||Log Rank|||Difference between treatment groups in PFS||||0.4798
71861611|NCT00940875|143238329|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.3||||0.4805|TWO_SIDED|95.0|0.63|2.68|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), disease stage, histology, and smoking status.|||2.68|0.63|0.4805
71861612|NCT00940875|143238330|SUPERIORITY_OR_OTHER||Difference in Response Rates|-11.54|||||TWO_SIDED|95.0|-40.3|17.2|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 8||17.2|-40.3|
71861613|NCT00940875|143238330|SUPERIORITY_OR_OTHER||Difference in Response Rates|-13.46|||||TWO_SIDED|95.0|-36.0|9.0|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 16||9.0|-36.0|
71861614|NCT00940875|143238332|SUPERIORITY_OR_OTHER|||||||0.5393|TWO_SIDED||||||Log Rank|||Difference between treatment groups in OS||||0.5393
71861615|NCT00940875|143238332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.5399|TWO_SIDED|95.0|0.38|1.66|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by ECOG PS, disease stage, histology, and smoking status.|||1.66|0.38|0.5399
71861616|NCT01575873|143238369|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -1.1 percentage points for the glucocorticoid-initiating subpopulation.|LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.|ANCOVA||Least Squares (LS) Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction."||3.9|2.0|< 0.001
71861617|NCT01575873|143238369|NON_INFERIORITY|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of -0.7 percentage points for the glucocorticoid-continuing subpopulation.|LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
71861618|NCT01575873|143238370|SUPERIORITY||LS Mean Difference|2.9|||<|0.001|TWO_SIDED|95.0|2.0|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.0|< 0.001
71861619|NCT01575873|143238370|SUPERIORITY||LS Mean Difference|2.2|||<|0.001|TWO_SIDED|95.0|1.4|3.0||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.0|1.4|< 0.001
71861620|NCT01575873|143238371|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|0.8|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||2.1|0.8|< 0.001
71861621|NCT01575873|143238371|SUPERIORITY||LS Mean Difference|1.5|||<|0.001|TWO_SIDED|95.0|1.0|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||2.1|1.0|< 0.001
71861622|NCT01575873|143238372|SUPERIORITY||LS Mean Difference|4.5|||<|0.001|TWO_SIDED|95.0|3.2|5.8||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||5.8|3.2|< 0.001
71861623|NCT01575873|143238372|SUPERIORITY||LS Mean Difference|3.2|||<|0.001|TWO_SIDED|95.0|2.0|4.3||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||4.3|2.0|< 0.001
71907658|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.89||||0.223|TWO_SIDED|95.0|-18.02|4.24||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||4.24|-18.02|0.223
71907659|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.808|TWO_SIDED|95.0|-9.44|12.1||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||12.10|-9.44|0.808
71688729|NCT03749109|142892876|OTHER||Difference in LS mean|0.07||||0.93|TWO_SIDED|95.0|-1.45|1.58|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||1.58|-1.45|0.93
71681524|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|TWO_SIDED|95.0|-2.9|0.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19F||0.9|-2.9|< 0.001
71688730|NCT03749109|142892876|OTHER||Difference in LS mean|-0.13||||0.85|TWO_SIDED|95.0|-1.58|1.32|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 3||1.32|-1.58|0.85
71861624|NCT01575873|143238373|SUPERIORITY||LS Mean Difference|3.1|||<|0.001|TWO_SIDED|95.0|2.2|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."||3.9|2.2|< 0.001
71861625|NCT01575873|143238373|SUPERIORITY||LS Mean Difference|2.5|||<|0.001|TWO_SIDED|95.0|1.7|3.2||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (\< 12 months vs ≥ 12 months)."||3.2|1.7|< 0.001
71861626|NCT00762476|143238374|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
71861627|NCT00762476|143238375|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|95.0|||||Poisson regression|||||||>0.5000
71688731|NCT03749109|142892876|OTHER||Difference in LS mean|0.01||||0.99|TWO_SIDED|95.0|-1.68|1.69|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||1.69|-1.68|0.99
71861628|NCT00762476|143238376|SUPERIORITY_OR_OTHER|||||||0.3451|TWO_SIDED|95.0|||||Poisson regression|||||||0.3451
71861629|NCT01637077|143238414|SUPERIORITY|||||||0.56|||||||Kruskal-Wallis|||||||0.56
71861630|NCT01637077|143238415|SUPERIORITY|||||||0.48|||||||Kruskal-Wallis|||||||0.48
71861631|NCT01637077|143238416|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||Worst pain over the past 24 hours||||0.62
71861632|NCT01637077|143238416|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||Average pain over the past 24 hours||||0.22
71861633|NCT01637077|143238416|SUPERIORITY|||||||0.07|||||||Kruskal-Wallis|||Least pain over the past 24 hours||||0.07
71681525|NCT02987972|142881454|NON_INFERIORITY|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|4.2|||<|0.001|TWO_SIDED|95.0|-0.1|8.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 23F||8.7|-0.1|< 0.001
71681526|NCT02987972|142881455|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.64|
71907660|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07||||0.049|TWO_SIDED|95.0|-20.11|-0.04||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||-0.04|-20.11|0.049
71907661|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.99||||0.842|TWO_SIDED|95.0|-10.85|8.86||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.86|-10.85|0.842
71907662|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.03||||0.247|TWO_SIDED|95.0|-13.58|3.52||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||3.52|-13.58|0.247
71907663|NCT01115738|143337425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.942|TWO_SIDED|95.0|-8.09|8.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values \<0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.||||8.71|-8.09|0.942
71907664|NCT01115738|143337428|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.449||||0.8711|TWO_SIDED|95.0|-38.81|45.71|||ANOVA|||A linear ANOVA model with PRU values at baseline for clopidogrel treated participants as response and CYP2C19 metabolizer status as covariate of main interest.||45.71|-38.81|0.8711
71907665|NCT01115738|143337429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.714||||0.7875|TWO_SIDED|95.0|-72.78|55.36|||ANOVA|||A linear ANOVA model with PRU values of 6 hours post Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||55.36|-72.78|0.7875
71861634|NCT01637077|143238418|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
71861635|NCT01637077|143238419|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
71861636|NCT01637077|143238420|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
71861637|NCT01637077|143238421|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||0.12
71861638|NCT01637077|143238422|SUPERIORITY|||||||0.78|||||||Chi-squared|||||||0.78
71861639|NCT01637077|143238423|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71861640|NCT01637077|143238424|SUPERIORITY|||||||0.46|||||||Kruskal-Wallis|||Sensory neuropathy||||0.46
71861641|NCT01637077|143238424|SUPERIORITY|||||||0.86|||||||Kruskal-Wallis|||Autonomic neuropathy||||0.86
71861642|NCT01637077|143238424|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Motor neuropathy||||0.40
71861643|NCT01011868|143238441|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.78|-0.33||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo~* H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo"||-0.33|-0.78|<0.0001
71861644|NCT01011868|143238441|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|97.5|-0.93|-0.47||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~* H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo~* H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo"||-0.47|-0.93|<0.0001
71861645|NCT01011868|143238442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.518|||<|0.0001|TWO_SIDED|95.0|3.262|9.334|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c.||Empagliflozin 10 mg vs Placebo at 18 weeks||9.334|3.262|<0.0001
71861646|NCT01011868|143238442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.883|||<|0.0001|TWO_SIDED|95.0|2.859|8.338|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||8.338|2.859|<0.0001
71861647|NCT01011868|143238442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.471|||<|0.0001|TWO_SIDED|95.0|2.077|5.802|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||5.802|2.077|<0.0001
71861648|NCT01011868|143238442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.825|||<|0.0001|TWO_SIDED|95.0|2.268|6.451|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||6.451|2.268|<0.0001
71861649|NCT01011868|143238442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.802||||0.0002|TWO_SIDED|95.0|1.639|4.789|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.789|1.639|0.0002
71861650|NCT01011868|143238442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.527|||<|0.0001|TWO_SIDED|95.0|2.051|6.066|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.066|2.051|<0.0001
71681527|NCT02987972|142881455|OTHER||GMC Ratio|1.98|||||TWO_SIDED|95.0|1.75|2.23|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.23|1.75|
71681528|NCT02987972|142881455|OTHER||GMC Ratio|1.04|||||TWO_SIDED|95.0|0.92|1.16|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.16|0.92|
71861651|NCT01011868|143238443|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.4|STANDARD_ERROR_OF_MEAN|4.65|<|0.0001|TWO_SIDED|95.0|-37.54|-19.27|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-19.27|-37.54|<0.0001
71861652|NCT01011868|143238443|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.21|STANDARD_ERROR_OF_MEAN|4.81|<|0.0001|TWO_SIDED|95.0|-43.67|-24.76|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks||-24.76|-43.67|<0.0001
71861653|NCT01011868|143238443|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.75|STANDARD_ERROR_OF_MEAN|5.02||0.0328|TWO_SIDED|95.0|-20.62|-0.89|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks||-0.89|-20.62|0.0328
71861654|NCT01011868|143238443|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.16|STANDARD_ERROR_OF_MEAN|5.16||0.0002|TWO_SIDED|95.0|-29.31|-9.01|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-9.01|-29.31|0.0002
71861655|NCT01011868|143238443|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.03|STANDARD_ERROR_OF_MEAN|5.07||0.3216|TWO_SIDED|95.0|-15.01|4.94|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||4.94|-15.01|0.3216
71688732|NCT03749109|142892877|OTHER||Difference in LS mean|-7.35||||0.75|TWO_SIDED|95.0|-53.97|39.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 2||39.27|-53.97|0.75
71861656|NCT01011868|143238443|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.95|STANDARD_ERROR_OF_MEAN|5.23||0.0229|TWO_SIDED|95.0|-22.24|-1.67|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-1.67|-22.24|0.0229
71861657|NCT01011868|143238444|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.12|STANDARD_ERROR_OF_MEAN|5.22|<|0.0001|TWO_SIDED|95.0|-35.38|-14.86|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-14.86|-35.38|<0.0001
71861658|NCT01011868|143238444|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.01|||<|0.0001|TWO_SIDED|95.0|-41.62|-20.39|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||-20.39|-41.62|<0.0001
71861659|NCT01011868|143238444|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.2|STANDARD_ERROR_OF_MEAN|5.15|<|0.0484|TWO_SIDED|95.0|-20.33|-0.07|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.07|-20.33|<0.0484
71861660|NCT01011868|143238444|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.42|STANDARD_ERROR_OF_MEAN|5.3||0.0003|TWO_SIDED|95.0|-29.84|-8.99|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-8.99|-29.84|0.0003
71861661|NCT01011868|143238444|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.73|STANDARD_ERROR_OF_MEAN|5.07||0.3517||95.0|-14.71|5.25|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||5.25|-14.71|0.3517
71861662|NCT01011868|143238444|SUPERIORITY_OR_OTHER||Adjusted mean difference|-12.39|STANDARD_ERROR_OF_MEAN|5.23||0.0185|TWO_SIDED|95.0|-22.69|-2.1|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-2.10|-22.69|0.0185
71861663|NCT01011868|143238445|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.58|STANDARD_ERROR_OF_MEAN|2.4||0.0213|TWO_SIDED|95.0|-10.32|-0.84|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.|Empagliflozin versus Placebo 10 mg at 54 weeks||-0.84|-10.32|0.0213
71861664|NCT01011868|143238445|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.69|STANDARD_ERROR_OF_MEAN|2.49||0.0237|TWO_SIDED|95.0|-10.62|-0.77|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Empagliflozin versus Placebo 25 mg at 54 weeks||-0.77|-10.62|0.0237
71861665|NCT01011868|143238445|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.18||0.0024|TWO_SIDED|97.5|-11.56|-1.77||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 10 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo"||-1.77|-11.56|0.0024
71861666|NCT01011868|143238445|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.92|STANDARD_ERROR_OF_MEAN|2.25||0.009|TWO_SIDED|97.5|-11.0|-0.85||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 25 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo"||-0.85|-11.00|0.0090
71861667|NCT01011868|143238446|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.04|STANDARD_ERROR_OF_MEAN|0.95||0.032|TWO_SIDED|95.0|-3.9|-0.18|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 10 mg vs Placebo||-0.18|-3.90|0.0320
71861668|NCT01011868|143238446|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.99||0.3818|TWO_SIDED|95.0|-2.81|1.08|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 25 mg vs Placebo||1.08|-2.81|0.3818
71861669|NCT01011868|143238446|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.0001|TWO_SIDED|95.0|-2.89|-1.05|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-1.05|-2.89|<0.0001
71861670|NCT01011868|143238446|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.17|STANDARD_ERROR_OF_MEAN|0.49|<|0.0001|TWO_SIDED|95.0|-3.13|-1.22|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-1.22|-3.13|<0.0001
71907666|NCT01115738|143337429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.435||||0.8913|TWO_SIDED|95.0|-53.23|46.37|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||46.37|-53.23|0.8913
71907667|NCT01115738|143337429|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.6229|TWO_SIDED|95.0|-35.43|58.83|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.||58.83|-35.43|0.6229
71907668|NCT01709981|143337431|EQUIVALENCE|Mann-Whitney||||||0.31|||||||Wilcoxon (Mann-Whitney)|2-sided||||||0.31
71681529|NCT02987972|142881455|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.68|0.89|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.89|0.68|
71861671|NCT01011868|143238446|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.63|STANDARD_ERROR_OF_MEAN|1.1||0.0012|TWO_SIDED|95.0|-5.81|-1.45|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 10 mg vs Placebo||-1.45|-5.81|0.0012
71861672|NCT01011868|143238446|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.12|STANDARD_ERROR_OF_MEAN|1.15||0.0073|TWO_SIDED|95.0|-5.39|-0.85|||Mixed Models Analysis|Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects|Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 25 mg vs Placebo||-0.85|-5.39|0.0073
71861673|NCT01011868|143238448|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.68|-0.26|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo||-0.26|-0.68|<0.0001
71861674|NCT01011868|143238448|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.95|-0.52|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo||-0.52|-0.95|<0.0001
71861675|NCT01011868|143238448|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|97.5|-0.73|-0.19||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 10 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo \<0.3%"||-0.19|-0.73|0.0001
71907669|NCT01669811|143337446|SUPERIORITY_OR_OTHER||Difference in proportions|23.8|||<|0.0001|TWO_SIDED|95.0|14.9|32.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||32.6|14.9|<0.0001
71681530|NCT02987972|142881455|OTHER||GMC Ratio|0.54|||||TWO_SIDED|95.0|0.47|0.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.63|0.47|
71861676|NCT01011868|143238448|NON_INFERIORITY_OR_EQUIVALENCE|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|97.5|-0.9|-0.34||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 25 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo \<0.3%"||-0.34|-0.90|<0.0001
71861677|NCT01011868|143238450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.096||||0.0005|TWO_SIDED|95.0|1.846|9.088|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 18 weeks||9.088|1.846|0.0005
71861678|NCT01011868|143238450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.636||||0.0002|TWO_SIDED|95.0|2.083|10.321|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks||10.321|2.083|0.0002
71907670|NCT01669811|143337447|SUPERIORITY_OR_OTHER||Difference in proportions|32.8|||<|0.0001|TWO_SIDED|95.0|21.9|42.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd||42.6|21.9|<0.0001
71681531|NCT02987972|142881455|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.84|1.26|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.26|0.84|
71907671|NCT01669811|143337448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.1452|TWO_SIDED|95.0|0.91|1.83|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||1.83|0.91|0.1452
71907672|NCT01669811|143337449|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46||||0.0837|TWO_SIDED|95.0|0.97|2.18|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.18|0.97|0.0837
71907673|NCT01669811|143337450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.2678|TWO_SIDED|95.0|0.8|2.26|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.26|0.80|0.2678
71907674|NCT01669811|143337451|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6389|TWO_SIDED|95.0|0.62|2.12|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.12|0.62|0.6389
71907675|NCT01669811|143337452|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.38||||0.4485|TWO_SIDED|95.0|0.8|2.38|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd||2.38|0.80|0.4485
71907676|NCT00077376|143337453|SUPERIORITY_OR_OTHER||Objective response rate|41.0|||||TWO_SIDED|95.0|26.0|58.0||||||||58|26|
71907677|NCT00077376|143337454|SUPERIORITY_OR_OTHER||Objective response rate|44.0|||||TWO_SIDED|95.0|31.0|58.0||||||||58|31|
71907678|NCT00225147|143337513|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
71907679|NCT00225147|143337513|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
71907680|NCT00225147|143337514|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Log Rank|||||||0.040
71907681|NCT00225147|143337514|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
71907682|NCT00868166|143337549|SUPERIORITY|||||||0.71|||||||Stratified Log-Rank Test|||||||0.71
71907683|NCT00868166|143337550|SUPERIORITY|||||||0.83|||||||Stratified Log-Rank Test|||||||0.83
71907684|NCT00868166|143337550|SUPERIORITY|||||||0.73|||||||Non-stratified Log-Rank Test|||||||0.73
71861679|NCT01011868|143238450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.1248|TWO_SIDED|95.0|0.856|3.575|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks||3.575|0.856|0.1248
71907685|NCT00868166|143337552|SUPERIORITY|||||||0.21|||||||Stratified Log-Rank Test|||||||0.21
71907686|NCT00868166|143337552|SUPERIORITY|||||||0.2|||||||Non-stratified Log-Rank Test|||||||0.20
71907687|NCT00868166|143337554|SUPERIORITY|||||||0.56|||||||Stratified Log-Rank Test|||||||0.56
71907688|NCT00074802|143337557|SUPERIORITY||Mean Difference (Net)|-5.43||||0.267|TWO_SIDED|95.0|-15.05|4.19|||Mixed Models Analysis|||||4.19|-15.05|.267
71907689|NCT00074802|143337558|SUPERIORITY|||||||0.018||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of responder status.||||.018
71907690|NCT00074802|143337558|SUPERIORITY|||||||0.034||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of remitter status.||||.034
71907691|NCT00074802|143337559|SUPERIORITY||Mean Difference (Net)|-3.21||||0.0005|TWO_SIDED|95.0|-5.02|-1.39|||Mixed Models Analysis|||||-1.39|-5.02|.0005
71907692|NCT00074802|143337560|SUPERIORITY||Mean Difference (Net)|-5.61||||0.0775|TWO_SIDED|95.0|-11.84|0.62|||Mixed Models Analysis|||||0.62|-11.84|.0775
71907693|NCT00074802|143337561|SUPERIORITY||Mean Difference (Net)|-5.53||||0.0006|TWO_SIDED|95.0|-8.7|-2.35|||Mixed Models Analysis||Paroxetine+CBT \> Paroxetine alone in BFNE change.|||-2.35|-8.70|.0006
71907694|NCT00074802|143337562|SUPERIORITY||Mean Difference (Net)|0.2||||0.871|TWO_SIDED|95.0|-2.16|2.55|||Mixed Models Analysis|||||2.55|-2.16|.871
71907695|NCT00074802|143337563|SUPERIORITY||Median Difference (Net)|0.41||||0.949|TWO_SIDED|95.0|-11.95|12.76|||Mixed Models Analysis|||||12.76|-11.95|.949
71861680|NCT01011868|143238450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.423||||0.0132|TWO_SIDED|95.0|1.203|4.879|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks||4.879|1.203|0.0132
71861681|NCT01011868|143238450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.939||||0.0986|TWO_SIDED|95.0|0.884|4.256|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks||4.256|0.884|0.0986
71861682|NCT01011868|143238450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.239||||0.0024|TWO_SIDED|95.0|1.518|6.911|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks||6.911|1.518|0.0024
71861683|NCT01210651|143238480|SUPERIORITY_OR_OTHER|||||||0.034||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value \< 0.05 required a priori to reject the null hypothesis.|Regression, Generalized Least Squares|||A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.||||0.034
71861684|NCT01210651|143238481|SUPERIORITY_OR_OTHER|||||||0.02||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.||||0.02
71861685|NCT01210651|143238482|SUPERIORITY_OR_OTHER|||||||0.018||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value \< 0.05 required a priori to reject the null hypothesis.|Fisher Exact|||Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.||||0.018
71861686|NCT01210651|143238483|SUPERIORITY_OR_OTHER|||||||0.5||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.||||0.50
71907696|NCT00654953|143337571|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|degrees of freedom for medication group = 2 (group)||The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.||||0.05
71861687|NCT01210651|143238484|SUPERIORITY_OR_OTHER|||||||0.053||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value \< 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.||||0.053
71861688|NCT04855734|143238528|SUPERIORITY||Mean ratio|0.962||||0.835|TWO_SIDED|95.0|0.661|1.396||Threshold for significance was \<0.05.|Mixed Models Analysis|||||1.396|0.661|0.835
71861689|NCT04855734|143238529|SUPERIORITY||Mean ratio|0.826||||0.032|TWO_SIDED|95.0|0.75|0.986||\<0.05 was threshold for significance level.|Mixed Models Analysis|||Meaning/Peace subscale which was a primary outcome.||0.986|0.75|0.032
71861690|NCT04855734|143238535|SUPERIORITY||Mean ratio|1.052||||0.284|TWO_SIDED|95.0|0.959|1.157||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver strain subscale scores at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels.||1.157|0.959|0.284
71861691|NCT04855734|143238535|SUPERIORITY||Mean ratioj|0.931||||0.228|TWO_SIDED|95.0|0.827|1.048||\<0.05 threshold for significance level.|Mixed Models Analysis|||Caregiver distress subscale controlling for baseline levels.||1.048|0.827|0.228
71861692|NCT04855734|143238535|SUPERIORITY||Mean ratio|0.984||||0.504|TWO_SIDED|95.0|0.94|1.032||\<0.05 significance level.|Mixed Models Analysis|||Family well-being subscale controlling for baseline levels.||1.032|0.94|0.504
71861693|NCT04855734|143238535|SUPERIORITY||Mean ratio|0.995||||0.741|TWO_SIDED|95.0|0.967|1.024||\<0.05 significance level.|Mixed Models Analysis|||Positive Caregiving Appraisals subscale at 3 month follow up, controlling for baseline levels.||1.024|0.967|0.741
71861694|NCT03732677|143238546|SUPERIORITY||Odds Ratio (OR)|1.6||||0.0005|TWO_SIDED|95.0|1.227|2.084|||Regression, Logistic|Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .||||2.084|1.227|0.0005
71861695|NCT03732677|143238547|SUPERIORITY||Hazard Ratio (HR)|0.68|||<|0.0001|TWO_SIDED|95.877|0.554|824.0||Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Log Rank||The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)||95% CI for hazard ratio: 0.558 - 0.817|0824|0.554|<0.0001
71861696|NCT03732677|143238548|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0021|TWO_SIDED|95.0|0.62|0.9|||Chi-squared|P-value is based on a chi-squared test with one degree of freedom.|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.90|0.62|0.0021
71861697|NCT03732677|143238549|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0265|TWO_SIDED|95.0|1.047|2.095|||Regression, Logistic|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|Strata adjusted odds ratio by the logistic regression method. Stratified by adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative).|||2.095|1.047|0.0265
71861698|NCT03732677|143238550|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.0106|TWO_SIDED|98.457|0.563|0.985|||Log Rank|Stratified by renal function (adequate vs borderline),tumor stage(T2N0vs \>T2N0), PDL1 status(high vs low/negative)|||95% CI: 0.594 to 0.934|0.985|0.563|0.0106
71681532|NCT02987972|142881455|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.92|0.73|
71681533|NCT02987972|142881455|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.00|0.77|
71681534|NCT02987972|142881455|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.75|1.03|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.03|0.75|
71907697|NCT01231607|143337572|SUPERIORITY_OR_OTHER||Least-squares (LS) mean difference|22.0||||0.046|TWO_SIDED|98.33|-4.4|48.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.|||48.4|-4.4|0.046
71907698|NCT01231607|143337572|SUPERIORITY_OR_OTHER||LS mean difference|67.9|||<|0.001|TWO_SIDED|98.33|41.6|94.2|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.|||94.2|41.6|<0.001
71907699|NCT01231607|143337572|SUPERIORITY_OR_OTHER||LS mean difference|94.4|||<|0.001|TWO_SIDED|98.33|67.8|121.0|||General linear model|Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.|Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.|||121.0|67.8|<0.001
71907700|NCT01231607|143337572|SUPERIORITY_OR_OTHER||Least squares mean difference|61.4|||<|0.001|TWO_SIDED|98.33|34.4|88.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.|||88.4|34.4|<0.001
71907701|NCT01231607|143337572|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|-39.4|||<|0.001||99.165|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
71907702|NCT01231607|143337572|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|6.5||||0.28||99.165|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.28
71907703|NCT01231607|143337572|NON_INFERIORITY_OR_EQUIVALENCE|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|33.0||||0.002||99.165|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.002
71907704|NCT01231607|143337572|SUPERIORITY_OR_OTHER||Least squares mean difference|-39.4|||<|0.001|TWO_SIDED|98.33|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.|||-12.7|-66.1|<0.001
71907705|NCT01231607|143337572|SUPERIORITY_OR_OTHER||Least squares mean difference|6.5||||0.56|TWO_SIDED|98.33|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.|||33.1|-20.1|0.56
71907706|NCT01231607|143337572|SUPERIORITY_OR_OTHER||Least squares mean difference|33.0||||0.003|TWO_SIDED|98.33|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.|||60|6.1|0.003
71922074|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|0.52|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-6.46|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.49|-6.46|
71922075|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-7.74|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||5.03|-7.74|
71688733|NCT03749109|142892877|OTHER||Difference in LS mean|17.31||||0.42|TWO_SIDED|95.0|-25.41|60.04|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Endometrioma at cycle 4||60.04|-25.41|0.42
71681535|NCT02987972|142881455|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.66|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||0.84|0.66|
71907707|NCT01797445|143337592|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentages|3.1||||0.13|TWO_SIDED|95.002|-1.0|7.1|||Cochran-Mantel-Haenszel|P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or \> 100,000 copies/mL) and region (US vs ex-US).|The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was \< 12% worse than the E/C/F/TDF group.||7.1|-1.0|0.13
71907708|NCT04547998|143337609|SUPERIORITY|The difference in the proportion of responders (RECELL-Control) was tested for superiority of RECELL treatment (with a 10% superiority margin). For the null hypothesis to be rejected and super-superiority of RECELL to Control to be established, the lower limit of the 2-sided 95% CI of the difference in the proportion of responders (RECELL-Control) had to be greater than 10%.||||||0.012|||||||continuity-corrected method|Liu et al 2002||||||0.012
71907709|NCT04547998|143337610|SUPERIORITY||||||<|0.001||||||P-value based on Wilcoxon signed rank test at 2-sided 0.05 significance level. The Wilcoxon signed rank test was based on the following repigmentation categories: 0% to 25%, 26% to 50%, 51% to 79%, and 80% to 100%.|Wilcoxon (Mann-Whitney)|||||||<0.001
71907710|NCT04547998|143337611|SUPERIORITY|||||||1||||||2-sided (0.05 significance level), based on 19 participants with assessable color matching outcomes for both treatments|Wilcoxon (Mann-Whitney)|||||||1.000
71907711|NCT04904614|143337637|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
71907712|NCT04904614|143337638|SUPERIORITY|||||||0.13|||||||Chi-squared|||||||0.13
71907713|NCT04904614|143337639|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.6
71907714|NCT04904614|143337641|SUPERIORITY|||||||0.97|||||||Chi-squared|||||||0.97
71907715|NCT00881361|143337646|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||0.003
71907716|NCT01413542|143337652|SUPERIORITY_OR_OTHER||Estimate of Difference||||<|0.001|TWO_SIDED|||||Effect of ACE inhibition on FBF response to bradykinin (p\<0.001). Other comparisons: Effect of DPP4 inhibition on FBF response to bradykinin (p=0.89); Effect of ACE (p=0.16), DPP4 (p=0.82), or combined inhibition (p=0.35) on FBF response to sub P.|Mixed Models Analysis|"Effect of DPP4 inhibition on vasodilator response to GLP-1 (p=0.14) or BNP (p=0.85).~p\<0.05 threshold for statistical significance."||"Group 1: The effect of treatment (placebo, ACE or DPP4 inhibitor, or the combination) on vasodilator response to peptide, measured as forearm blood flow was determined.~Group 2: The effect of treatment (placebo, DPP4 inhibitor) on vasodilator response to peptide, measured as percent change in forearm blood flow was determined."||||<0.001
71907717|NCT01413542|143337653|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Effect of DPP4 inhibition on tPA release during sub P in women (p=0.02 vs. placebo).Effect of ACE inhibition on tPA release during sub P in women (p\<0.001); effect of DPP4 inhibition on tPA release during sub P and (p=0.001 vs. ACE inhibition alone).|Mixed Models Analysis|p\<0.05 threshold for statistical significance||||||0.02
71907718|NCT01413542|143337654|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Effect of combined ACE and DPP4 inhibition on change in heart rate in response to max dose substance P (p=0.011 vs placebo; ).|Wilcoxon signed rank|p\<0.05 threshold for statistical significance.||||||0.011
71907719|NCT01413542|143337655|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with placebo.|Wilcoxon signed rank|||||||0.05
71907720|NCT01413542|143337655|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with ACE inhibition alone (p=0.007).|Wilcoxon signed rank|||||||0.007
71907721|NCT01413542|143337656|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during placebo (p=0.01).|wilxocon signed rank test|||||||0.01
71907722|NCT01413542|143337656|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during sitagliptin (p=0.01).|Wilcoxon signed rank|||||||0.01
71907723|NCT01413542|143337656|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|||||Effect of DPP4 inhibition on venous GLP-1 levels at high dose of intra-arterial GLP-1 (p=0.04 vs. placebo).|Wilcoxon signed rank|||||||0.04
71907724|NCT02505542|143337657|SUPERIORITY||Odds Ratio (OR)|18.822|||<|0.001|TWO_SIDED|95.0|9.605|38.864||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||38.864|9.605|<0.001
71907725|NCT02505542|143337657|SUPERIORITY||Odds Ratio (OR)|14.069|||<|0.001|TWO_SIDED|95.0|7.395|27.955||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio \> 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.||27.955|7.395|<0.001
71907726|NCT02505542|143337661|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
71907727|NCT02505542|143337661|OTHER||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).||||<0.001
71861699|NCT03732677|143238551|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0002|TWO_SIDED|95.0|0.541|0.826|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.826|0.541|0.0002
71861700|NCT03732677|143238552|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0081|TWO_SIDED|95.0|0.516|0.907|||Log Rank|Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)|The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)|||0.907|0.516|0.0081
71861701|NCT04535544|143238814|SUPERIORITY||Difference of percentage|23.7||||0.011|TWO_SIDED|95.0|3.52|43.96|||Mantel-Haenszel|||Stratum-adjusted Mantel-Haenszel (MH) test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||43.96|3.52|0.011
71861702|NCT04535544|143238815|SUPERIORITY||Difference of percentage|26.8||||0.003|TWO_SIDED|95.0|7.38|46.21|||Mantel-Haenszel|||Stratum-adjusted MH test was used to assess the difference of percentage based on stratification factor: HBeAg status at screening (positive vs negative).||46.21|7.38|0.003
71861703|NCT05131477|143238824|SUPERIORITY||LS Mean Difference|-32.1|STANDARD_ERROR_OF_MEAN|6.01|<|0.0001|TWO_SIDED|95.0|-43.9|-20.3|||ANCOVA||LS Mean Difference|||-20.3|-43.9|<0.0001
71861704|NCT05131477|143238824|SUPERIORITY||LS Mean Difference|-27.3|STANDARD_ERROR_OF_MEAN|5.98|<|0.0001|TWO_SIDED|95.0|-39.1|-15.6|||ANCOVA||LS Mean Difference|||-15.6|-39.1|<0.0001
71861705|NCT05131477|143238824|SUPERIORITY||LS Mean Difference|-22.2|STANDARD_ERROR_OF_MEAN|6.01||0.0002|TWO_SIDED|95.0|-34.0|-10.4|||ANCOVA||LS Mean Difference|||-10.4|-34.0|0.0002
71861706|NCT05131477|143238824|SUPERIORITY||Mean Difference (Final Values)|-30.2|STANDARD_ERROR_OF_MEAN|5.95|<|0.0001|TWO_SIDED|95.0|-41.9|-18.5|||ANCOVA|||||-18.5|-41.9|<0.0001
71861707|NCT05131477|143238825|SUPERIORITY||LS Mean Difference|-36.8|STANDARD_ERROR_OF_MEAN|6.62|<|0.0001|TWO_SIDED|95.0|-49.8|-23.8|||ANCOVA||LS Mean Difference|||-23.8|-49.8|<0.0001
71861708|NCT05131477|143238825|SUPERIORITY||LS Mean Difference|-24.6|STANDARD_ERROR_OF_MEAN|6.67||0.0002|TWO_SIDED|95.0|-37.7|-11.6|||ANCOVA||LS Mean Difference|||-11.6|-37.7|0.0002
71861709|NCT05131477|143238825|SUPERIORITY||LS Mean Difference|-26.2|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.2|-13.1|||ANCOVA||LS Mean Difference|||-13.1|-39.2|<0.0001
71861710|NCT05131477|143238825|SUPERIORITY||LS Mean Difference|-26.8|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|-39.7|-13.9|||ANCOVA||LS Mean Difference|||-13.9|-39.7|<0.0001
71861711|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|< 0.0001
71681536|NCT02987972|142881455|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
71681537|NCT02987972|142881455|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.98|0.79|
71681538|NCT02987972|142881455|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.13|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.13|0.84|
71861712|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.27|||<|0.0001|TWO_SIDED|95.0|0.14|0.4|||Cochran-Mantel-Haenszel|||Week 16||0.40|0.14|< 0.0001
71681539|NCT02987972|142881455|OTHER||GMC Ratio|92.05|||||TWO_SIDED|95.0|80.84|104.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||104.81|80.84|
71681540|NCT02987972|142881455|OTHER||GMC Ratio|34.41|||||TWO_SIDED|95.0|28.5|41.54|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||41.54|28.50|
71681541|NCT02987972|142881455|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.74|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.94|0.74|
71861713|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.18|0.44|||Cochran-Mantel-Haenszel|||Week 16||0.44|0.18|<0.0001
71861714|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.42|||Cochran-Mantel-Haenszel|||Week 16||0.42|0.16|<0.0001
71861715|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.5|||Cochran-Mantel-Haenszel|||Week 24||0.5|0.23|<0.0001
71861716|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.21||||0.004|TWO_SIDED|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.07|0.0040
71861717|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.31|||<|0.0001|TWO_SIDED|95.0|0.17|0.45|||Cochran-Mantel-Haenszel|||||0.45|0.17|<0.0001
71861718|NCT05131477|143238826|SUPERIORITY||Proportion Difference|0.23||||0.0016|TWO_SIDED|95.0|0.09|0.36|||Cochran-Mantel-Haenszel|||||0.36|0.09|0.0016
71907728|NCT02505542|143337663|SUPERIORITY||Odds Ratio (OR)|17.94|||<|0.001|TWO_SIDED|95.0|8.95|35.961|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||35.961|8.950|<0.001
71907729|NCT02505542|143337663|SUPERIORITY||Odds Ratio (OR)|11.385|||<|0.001|TWO_SIDED|95.0|5.952|21.778|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||21.778|5.952|<0.001
71907730|NCT02505542|143337663|SUPERIORITY||Odds Ratio (OR)|17.653|||<|0.001|TWO_SIDED|95.0|8.333|37.399|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||37.399|8.333|<0.001
71907731|NCT02505542|143337663|SUPERIORITY||Odds Ratio (OR)|11.863|||<|0.001|TWO_SIDED|95.0|5.67|24.822|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.||24.822|5.670|<0.001
71907732|NCT02505542|143337664|SUPERIORITY||Odds Ratio (OR)|20.205|||<|0.001|TWO_SIDED|95.0|9.851|41.439|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||41.439|9.851|<0.001
71907733|NCT02505542|143337664|SUPERIORITY||Odds Ratio (OR)|12.07|||<|0.001|TWO_SIDED|95.0|6.275|23.218|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.218|6.275|<0.001
71907734|NCT02505542|143337665|SUPERIORITY||Odds Ratio (OR)|20.891|||<|0.001|TWO_SIDED|95.0|10.21|42.744|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||42.744|10.210|<0.001
71907735|NCT02505542|143337665|SUPERIORITY||Odds Ratio (OR)|10.377|||<|0.001|TWO_SIDED|95.0|5.456|19.738|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||19.738|5.456|<0.001
71907736|NCT02505542|143337666|SUPERIORITY||Odds Ratio (OR)|16.9|||<|0.001|TWO_SIDED|95.0|8.211|34.785|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.785|8.211|<0.001
71907737|NCT02505542|143337666|SUPERIORITY||Odds Ratio (OR)|12.072|||<|0.001|TWO_SIDED|95.0|5.954|24.476|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||24.476|5.954|<0.001
71907738|NCT02505542|143337667|SUPERIORITY||Odds Ratio (OR)|17.082|||<|0.001|TWO_SIDED|95.0|8.561|34.085|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||34.085|8.561|<0.001
71907739|NCT02505542|143337667|SUPERIORITY||Odds Ratio (OR)|11.503|||<|0.001|TWO_SIDED|95.0|5.939|22.278|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||22.278|5.939|<0.001
71907740|NCT02505542|143337668|OTHER||LS Mean Difference vs Placebo|-1.42|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.66|-1.17|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.17|-1.66|<0.001
71861719|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.17||||0.0022|TWO_SIDED|95.0|0.06|0.27|||Cochran-Mantel-Haenszel|||Week 16||0.27|0.06|0.0022
71861720|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.09||||0.0562|TWO_SIDED|95.0|0.0|0.18|||Cochran-Mantel-Haenszel|||Week 16||0.18|0|0.0562
71861721|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.14||||0.0054|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0054
71861722|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.2||||0.0003|TWO_SIDED|95.0|0.1|0.31|||Cochran-Mantel-Haenszel|||Week 16||0.31|0.1|0.0003
71861723|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.34|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||Cochran-Mantel-Haenszel|||Week 24||0.47|0.21|<0.0001
71861724|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.22||||0.0008|TWO_SIDED|95.0|0.1|0.34|||Cochran-Mantel-Haenszel|||Week 24||0.34|0.1|0.0008
71861725|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.16|0.41|||Cochran-Mantel-Haenszel|||Week 24||0.41|0.16|<0.0001
71681542|NCT02987972|142881455|OTHER||GMC Ratio|1.93|||||TWO_SIDED|95.0|1.71|2.18|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.18|1.71|
71861726|NCT05131477|143238827|SUPERIORITY||Proportion Difference|0.18||||0.0046|TWO_SIDED|95.0|0.06|0.3|||Cochran-Mantel-Haenszel|||Week 24||0.3|0.06|0.0046
71861727|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.19||||0.0006|TWO_SIDED|95.0|0.09|0.3|||Cochran-Mantel-Haenszel|||Week 16||0.3|0.09|0.0006
71861728|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.14||||0.0057|TWO_SIDED|95.0|0.04|0.24|||Cochran-Mantel-Haenszel|||Week 16||0.24|0.04|0.0057
71861729|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.16||||0.0038|TWO_SIDED|95.0|0.05|0.26|||Cochran-Mantel-Haenszel|||Week 16||0.26|0.05|0.0038
71861730|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.18||||0.0011|TWO_SIDED|95.0|0.07|0.28|||Cochran-Mantel-Haenszel|||Week 16||0.28|0.07|0.0011
71861731|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.23||||0.0002|TWO_SIDED|95.0|0.11|0.35|||Cochran-Mantel-Haenszel|||Week 24||0.35|0.11|0.0002
71861732|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.17||||0.0038|TWO_SIDED|95.0|0.06|0.28|||Cochran-Mantel-Haenszel|||Week 24||0.28|0.06|0.0038
71861733|NCT05131477|143238828|SUPERIORITY||Proportion Difference|0.21||||0.0006|TWO_SIDED|95.0|0.09|0.32|||Cochran-Mantel-Haenszel|||Week 24||0.32|0.09|0.0006
71861734|NCT05131477|143238828|SUPERIORITY||Proportion Difference|20.0||||0.0008|TWO_SIDED|95.0|9.0|32.0|||Cochran-Mantel-Haenszel|||Week 24||32|9|0.0008
71861735|NCT05101993|143238889|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71861736|NCT01124838|143238899|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.004|TWO_SIDED|95.0|0.39|0.84|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.||0.84|0.39|0.004
71861737|NCT01124838|143238899|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.37|0.74|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.||0.74|0.37|<0.001
71861738|NCT01124838|143238900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.14||||0.218|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|From ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.08|-0.37|0.218
71861739|NCT01124838|143238900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.15||||0.164|TWO_SIDED|95.0|-0.36|0.06|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.06|-0.36|0.164
71861740|NCT01124838|143238901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.13||||0.07|TWO_SIDED|95.0|-0.28|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.28|0.070
71861741|NCT01124838|143238901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.17||||0.016|TWO_SIDED|95.0|-0.31|-0.03|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||-0.03|-0.31|0.016
71681543|NCT02987972|142881455|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.14|0.90|
71861742|NCT01124838|143238902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.096|TWO_SIDED|95.0|-0.08|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.01|-0.08|0.096
71681544|NCT02987972|142881455|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.94|0.72|
71861743|NCT01124838|143238902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.04||||0.044|TWO_SIDED|95.0|-0.09|0.0|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||0.00|-0.09|0.044
71861744|NCT01124838|143238903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.491|TWO_SIDED|95.0|0.34|1.69|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.69|0.34|0.491
71861745|NCT01124838|143238903|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6||||0.185|TWO_SIDED|95.0|0.28|1.28|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.28|0.28|0.185
71861746|NCT01124838|143238904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-2.3||||0.451|TWO_SIDED|95.0|-8.5|3.8|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.8|-8.5|0.451
71861747|NCT01124838|143238904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-3.9||||0.174|TWO_SIDED|95.0|-9.7|1.8|||ANOVA|From ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||1.8|-9.7|0.174
71861748|NCT01124838|143238905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.12||||0.16|TWO_SIDED|95.0|-0.84|5.08|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.08|-0.84|0.160
71861749|NCT01124838|143238905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.77||||0.205|TWO_SIDED|95.0|-0.97|4.52|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.52|-0.97|0.205
71861750|NCT01124838|143238906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|1.88||||0.401|TWO_SIDED|95.0|-2.53|6.29|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.29|-2.53|0.401
71861751|NCT01124838|143238906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|2.36||||0.256|TWO_SIDED|95.0|-1.73|6.45|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||6.45|-1.73|0.256
71861752|NCT01124838|143238907|SUPERIORITY_OR_OTHER_LEGACY||Mena Difference|-0.1||||0.967|TWO_SIDED|95.0|-4.81|4.61|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.61|-4.81|0.967
71861753|NCT01124838|143238907|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.87||||0.714|TWO_SIDED|95.0|-5.53|3.79|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||3.79|-5.53|0.714
71681545|NCT02987972|142881455|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.49|0.66|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.66|0.49|
71681546|NCT02987972|142881455|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.1|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.10|0.74|
71861754|NCT01124838|143238908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|0.56||||0.83|TWO_SIDED|95.0|-4.56|5.68|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||5.68|-4.56|0.830
71861755|NCT01124838|143238908|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference|-0.49||||0.842|TWO_SIDED|95.0|-5.32|4.34|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.||4.34|-5.32|0.842
71861756|NCT04297618|143238909|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71861757|NCT04297618|143238910|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71861758|NCT00953147|143238940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||1.04|0.35|<0.0001
71861759|NCT00953147|143238940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54||||0.0005|TWO_SIDED|95.0|0.24|0.84||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.||0.84|0.24|0.0005
71861760|NCT00953147|143238941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.0014|TWO_SIDED|95.0|0.25|0.92|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.92|0.25|0.0014
71861761|NCT00953147|143238941|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.42||||0.0122|TWO_SIDED|95.0|0.12|0.72|||ANCOVA|||Dmitrienko's tree-structured gatekeeping method was used for multiple comparisons||0.72|0.12|0.0122
71861762|NCT00078338|143238954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.943||||0.643|TWO_SIDED|95.0|0.74|1.21|||Cox proportional hazards model|||||1.21|0.74|0.643
71861763|NCT03258723|143238955|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
71861764|NCT03258723|143238956|SUPERIORITY|||||||0.0005|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0005
71861765|NCT03258723|143238957|SUPERIORITY|||||||0.1809|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.1809
71861766|NCT03258723|143238958|SUPERIORITY|||||||0.0973|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.0973
71681547|NCT02987972|142881455|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.72|0.91|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.91|0.72|
71861767|NCT03258723|143238960|SUPERIORITY|||||||0.1992|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.1992
71861768|NCT03258723|143238961|SUPERIORITY|||||||0.7017|||||||t-test, 2 sided|||Within subject change on matched cases.||||0.7017
71861769|NCT03258723|143238962|SUPERIORITY|||||||0.1573|||||||McNemar|||Within group change from baseline assessed on matched cases in low activity group at baseline.||||0.1573
71861770|NCT03258723|143238962|SUPERIORITY|||||||0.4328|||||||McNemar|||Within group change from baseline assessed on matched cases in medium activity group at baseline.||||0.4328
71861771|NCT03258723|143238962|SUPERIORITY|||||||0.6698|||||||McNemar|||Within group change from baseline assessed on matched cases in high activity group at baseline.||||0.6698
71861772|NCT03258723|143238963|SUPERIORITY|||||||0.5271|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||0.5271
71861773|NCT03258723|143238964|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||Within group change from baseline assessed on matched cases.||||<0.0001
71861774|NCT00592293|143238968|OTHER||Cumulative incidence|17.0|||||TWO_SIDED|95.0|9.1|27.6||||||||27.6|9.1|
71861775|NCT00592293|143238969|OTHER||Percent Survival, Local Control|87.1|||||TWO_SIDED|95.0|78.1|93.7||||||||93.7|78.1|
71861776|NCT01606319|143238971|SUPERIORITY_OR_OTHER||relative rate|0.94||||0.67|TWO_SIDED|95.0|0.69|1.28|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.28|.69|0.67
71861777|NCT01606319|143238972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.5|TWO_SIDED|95.0|-0.039|0.0019|||ANCOVA|||||.0019|-0.039|0.5
71861778|NCT01606319|143238973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.69|TWO_SIDED|95.0|-0.9|0.6|||ANCOVA|||||0.6|-0.9|0.69
71861779|NCT01606319|143238974|SUPERIORITY_OR_OTHER||relative rate|0.99||||0.94|TWO_SIDED|95.0|0.72|1.37|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator|||1.37|0.72|.94
71861780|NCT01124097|143238997|SUPERIORITY_OR_OTHER|||||||0.9321|||||||Dunnett's test|||||||0.9321
71861781|NCT01124097|143238997|SUPERIORITY_OR_OTHER|||||||0.261|||||||Dunnett's test|||||||0.2610
71861782|NCT01124097|143238997|SUPERIORITY_OR_OTHER|||||||0.4764|||||||Dunnett's test|||||||0.4764
71922076|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-2.71|STANDARD_ERROR_OF_MEAN|4.21|||TWO_SIDED|95.0|-11.46|6.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.04|-11.46|
71861783|NCT00609947|143239009|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.2|STANDARD_DEVIATION|21.8|<|0.001|ONE_SIDED|95.0||||"The null and alternative hypotheses were:~H0: µSVS ≥µM H1: µSVS \< µM where µSVS was the mean in-segment 8-month percent diameter stenosis for the SVS study and µM was the mean in-segment 6-month percent diameter stenosis for Micro-Driver."|t-test, 2 sided|The sample size was not reduced below 158 evaluable subjects in order to support the analysis of the primary safety endpoint.||The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.||||<0.001
71861784|NCT00609947|143239010|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|13.5|STANDARD_ERROR_OF_MEAN|6.5||0.0041|ONE_SIDED|95.0||20.0|||t-test, 1 sided|||"The null and alternative hypotheses of interest are:~H0: xSVS \>= 20% vs. H1: xSVS \< 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%."||20||0.0041
71861785|NCT01304498|143239011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16||1.11|0.85|<0.001
71861786|NCT01304498|143239011|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was \>0.67|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.91|1.29|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18||1.29|0.91|<0.001
71861787|NCT01667549|143239025|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).||||||0.02||||||Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.|planned comparison|Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||0.02
71861788|NCT01667549|143239026|OTHER||||||<|0.02|||||||ANOVA|||Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor||||<0.02
71861789|NCT01667549|143239027|OTHER|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).|||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.|planned comparison|a Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
71861790|NCT01667549|143239028|OTHER||||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P\<0.02 were considered significant.|planned comparison|A Bonferroni adjustment was calculated and only planned comparison with P's\<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).||||<0.02
71861791|NCT01667549|143239029|OTHER||||||<|0.05|||||||ANOVA|||General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.||||<0.05
71861792|NCT02844777|143239039|OTHER|||||||0.9518|||||||ANCOVA|||||||0.9518
71861793|NCT02844777|143239039|OTHER|||||||0.2458|||||||ANCOVA|||||||0.2458
71861794|NCT02844777|143239040|OTHER|||||||0.6201|||||||Fisher Exact|||||||0.6201
71861795|NCT02844777|143239040|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71861796|NCT02844777|143239041|OTHER|||||||0.2912|||||||ANCOVA|||||||0.2912
71861797|NCT02844777|143239041|OTHER|||||||0.4168|||||||ANCOVA|||||||0.4168
71861798|NCT02844777|143239042|OTHER|||||||0.6458|||||||ANCOVA|||||||0.6458
71861799|NCT02844777|143239042|OTHER|||||||0.0721|||||||ANCOVA|||||||0.0721
71681548|NCT02987972|142881455|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.94|1.22|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||1.22|0.94|
71861800|NCT02844777|143239043|OTHER|||||||0.42|||||||ANCOVA|||||||0.4200
71861801|NCT02844777|143239043|OTHER|||||||0.0241|||||||ANCOVA|||||||0.0241
71861802|NCT00150618|143239044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||ANCOVA|||||||0.0041
71861803|NCT00150618|143239044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0176||95.0|||||ANCOVA|||||||0.0176
71861804|NCT00150618|143239044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||ANCOVA|||||||0.0016
71861805|NCT00150618|143239044|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006||95.0|||||ANCOVA|||||||0.0006
71861806|NCT00150618|143239045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0|||||ANCOVA|||||||0.0010
71861807|NCT00150618|143239045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0468||95.0|||||ANCOVA|||||||0.0468
71861808|NCT00150618|143239045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||ANCOVA|||||||0.0056
71861809|NCT00150618|143239045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237||95.0|||||ANCOVA|||||||0.0237
71681549|NCT02987972|142881455|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.71|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.97|0.71|
71681550|NCT02987972|142881455|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.88|1.12|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.12|0.88|
71907741|NCT02505542|143337668|OTHER||LS Mean Difference vs Placebo|-1.21|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.45|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.45|<0.001
71681551|NCT02987972|142881455|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.92|0.73|
71907742|NCT02505542|143337669|OTHER||LS Mean Difference vs Placebo|-2.46|STANDARD_ERROR_OF_MEAN|0.268|<|0.001|TWO_SIDED|95.0|-2.99|-1.94|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.94|-2.99|<0.001
71907743|NCT02505542|143337669|OTHER||LS Mean Difference vs Placebo|-2.24|STANDARD_ERROR_OF_MEAN|0.267|<|0.001|TWO_SIDED|95.0|-2.77|-1.72|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.72|-2.77|<0.001
71681552|NCT02987972|142881455|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.81|1.01|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.01|0.81|
71681553|NCT02987972|142881455|OTHER||GMC Ratio|1.18|||||TWO_SIDED|95.0|1.01|1.37|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.37|1.01|
71861810|NCT00150618|143239046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074||95.0|||||Cochran-Mantel-Haenszel|||||||0.0074
71861811|NCT00150618|143239046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0|||||Cochran-Mantel-Haenszel|||||||0.1404
71861812|NCT00150618|143239046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0055||95.0|||||Cochran-Mantel-Haenszel|||||||0.0055
71861813|NCT00150618|143239046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0041||95.0|||||Cochran-Mantel-Haenszel|||||||0.0041
71861814|NCT00150618|143239047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0303||95.0|||||Cochran-Mantel-Haenszel|||||||0.0303
71861815|NCT00150618|143239047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4982||95.0|||||Cochran-Mantel-Haenszel|||||||0.4982
71907744|NCT02505542|143337670|OTHER||LS Mean Difference vs Placebo|-1.57|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-2.04|-1.11|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-1.11|-2.04|<0.001
71907745|NCT02505542|143337670|OTHER||LS Mean Difference vs Placebo|-1.43|STANDARD_ERROR_OF_MEAN|0.238|<|0.001|TWO_SIDED|95.0|-1.9|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.96|-1.90|<0.001
71907746|NCT02505542|143337671|OTHER||LS Mean Difference vs Placebo|-0.2|STANDARD_ERROR_OF_MEAN|0.112|=|0.074|TWO_SIDED|95.0|-0.42|0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||0.02|-0.42|=0.074
71907747|NCT02505542|143337671|OTHER||LS Mean Difference vs Placebo|-0.24|STANDARD_ERROR_OF_MEAN|0.113|=|0.036|TWO_SIDED|95.0|-0.46|-0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.||-0.02|-0.46|=0.036
71907748|NCT02505542|143337672|SUPERIORITY||Odds Ratio (OR)|18.308|||<|0.001|TWO_SIDED|95.0|9.084|36.898|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||36.898|9.084|<0.001
71907749|NCT02505542|143337672|SUPERIORITY||Odds Ratio (OR)|12.02|||<|0.001|TWO_SIDED|95.0|6.255|23.098|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.||23.098|6.255|<0.001
71907750|NCT02505542|143337673|OTHER||LS Mean Difference vs Placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.76|=|0.195|TWO_SIDED|95.0|-2.5|0.51|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.51|-2.50|=0.195
71907751|NCT02505542|143337673|OTHER||LS Mean Difference vs Placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.76|=|0.432|TWO_SIDED|95.0|-2.11|0.91|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.91|-2.11|=0.432
71861816|NCT00150618|143239047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0|||||Cochran-Mantel-Haenszel|||||||0.0017
71861817|NCT00150618|143239047|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Cochran-Mantel-Haenszel|||||||0.0063
71861818|NCT00150618|143239048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0383||95.0|||||ANCOVA|||Psychosocial category||||0.0383
71861819|NCT00150618|143239048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5859||95.0|||||ANCOVA|||Psychosocial category||||0.5859
71861820|NCT00150618|143239048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2136||95.0|||||ANCOVA|||Psychosocial category||||0.2136
71861821|NCT00150618|143239048|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1483||95.0|||||ANCOVA|||Psychosocial category||||0.1483
71861822|NCT00825305|143239051|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean|-0.2|||||TWO_SIDED|95.0|-0.81|0.4|||ANOVA||Ratio of log2 mean (Zagreb/Essen) on day 14|||0.4|-0.81|
71861823|NCT00825305|143239052|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day7)|-0.21|||||TWO_SIDED|95.0|-0.77|0.35|||ANOVA||Ratio of log2 means (Zagreb/Essen) on day 7|||0.35|-0.77|
71861824|NCT00825305|143239052|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day 42)|-0.07|||||TWO_SIDED|95.0|-0.72|0.58|||ANOVA||Ratio of log2 mean (Zagreb/(Essen) on day 42|||0.58|-0.72|
71861825|NCT03617289|143239060|SUPERIORITY|||||||0.771||||||Threshold for statistical significance set at p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.771
71861826|NCT03617289|143239061|SUPERIORITY||||||<|0.046||||||Threshold for statistical significance was set at p\<0.05|Chi-squared|||||||<0.046
71681554|NCT02987972|142881455|OTHER||GMC Ratio|80.09|||||TWO_SIDED|95.0|70.3|91.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||91.24|70.30|
71681555|NCT02987972|142881455|OTHER||GMC Ratio|32.92|||||TWO_SIDED|95.0|27.25|39.78|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||39.78|27.25|
71681556|NCT02987972|142881456|OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-3.1|3.2||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||3.2|-3.1|
71861827|NCT02493946|143239062|SUPERIORITY||Treatment difference|80.8|||<|0.0001|TWO_SIDED|95.0|73.7|88.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders.||88.0|73.7|<0.0001
71861828|NCT02493946|143239063|SUPERIORITY||Treatment difference|75.0|||<|0.0001|TWO_SIDED|95.0|67.1|82.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||82.8|67.1|<0.0001
71861829|NCT02493946|143239063|SUPERIORITY||Treatment difference|74.1|||<|0.0001|TWO_SIDED|95.0|66.2|82.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||82.1|66.2|<0.0001
71861830|NCT02493946|143239063|SUPERIORITY||Treatment difference|53.6|||<|0.0001|TWO_SIDED|95.0|44.2|63.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||63.1|44.2|<0.0001
71861831|NCT02493946|143239065|SUPERIORITY||Treatment difference|58.0|||<|0.0001|TWO_SIDED|95.0|44.5|71.6||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||71.6|44.5|<0.0001
71861832|NCT02493946|143239065|SUPERIORITY||Treatment difference|56.8|||<|0.0001|TWO_SIDED|95.0|44.5|69.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||69.0|44.5|<0.0001
71861833|NCT02493946|143239065|SUPERIORITY||Treatment difference|62.5|||<|0.0001|TWO_SIDED|95.0|52.1|72.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||72.9|52.1|<0.0001
71861834|NCT02493946|143239065|SUPERIORITY||Treatment difference|42.6|||<|0.0001|TWO_SIDED|95.0|29.5|55.7||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||55.7|29.5|<0.0001
71861835|NCT02493946|143239066|SUPERIORITY||Treatment difference|61.1|||<|0.0001|TWO_SIDED|95.0|51.9|70.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||70.3|51.9|<0.0001
71861836|NCT02493946|143239066|SUPERIORITY||Treatment difference|65.8|||<|0.0001|TWO_SIDED|95.0|56.8|74.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||74.8|56.8|<0.0001
71861837|NCT02493946|143239066|SUPERIORITY||Treatment difference|70.5|||<|0.0001|TWO_SIDED|95.0|62.2|78.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||78.8|62.2|<0.0001
71861838|NCT02493946|143239066|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|24.0|42.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||42.0|24.0|<0.0001
71861839|NCT02493946|143239067|SUPERIORITY||Treatment difference|68.2|||<|0.0001|TWO_SIDED|95.0|58.2|78.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Linear|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.||78.3|58.2|<0.0001
71907752|NCT02505542|143337674|OTHER||LS Mean Difference vs Placebo|-0.4|STANDARD_ERROR_OF_MEAN|0.19|=|0.04|TWO_SIDED|95.0|-0.78|-0.02|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||-0.02|-0.78|=0.040
71861840|NCT02493946|143239067|SUPERIORITY||Treatment difference|77.4|||<|0.0001|TWO_SIDED|95.0|68.6|86.2||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.||86.2|68.6|<0.0001
71861841|NCT02493946|143239067|SUPERIORITY||Treatment difference|74.4|||<|0.0001|TWO_SIDED|95.0|65.7|83.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.||83.1|65.7|<0.0001
71861842|NCT02493946|143239067|SUPERIORITY||Treatment difference|51.0|||<|0.0001|TWO_SIDED|95.0|42.0|59.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.||59.9|42.0|<0.0001
71861843|NCT02493946|143239068|SUPERIORITY||Hazard Ratio (HR)|15.296|||<|0.0001|TWO_SIDED||||||Cox proportional hazard model|The cox proportional hazard model used centre, gender and ILA baseline severity score as covariates.||Treatment difference in median time to onset of treatment response.||||<0.0001
71861844|NCT02493946|143239069|SUPERIORITY||Treatment difference|8.6|||<|0.0001|TWO_SIDED|95.0|5.2|12.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference ( BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||12.0|5.2|<0.0001
71861845|NCT02493946|143239069|SUPERIORITY||Treatment difference|11.1|||<|0.0001|TWO_SIDED|95.0|7.4|14.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||14.8|7.4|<0.0001
71861846|NCT02493946|143239069|SUPERIORITY||Treatment difference|10.4|||<|0.0001|TWO_SIDED|95.0|6.8|14.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||14.0|6.8|<0.0001
71861847|NCT02493946|143239069|SUPERIORITY||Treatment difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.9|13.3||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||13.3|5.9|<0.0001
71861848|NCT02493946|143239070|SUPERIORITY||Treatment difference|9.3|||<|0.0001|TWO_SIDED|95.0|5.0|13.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||13.6|5.0|<0.0001
71861849|NCT02493946|143239070|SUPERIORITY||Treatment difference|11.4|||<|0.0001|TWO_SIDED|95.0|6.7|16.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||16.0|6.7|<0.0001
71861850|NCT02493946|143239070|SUPERIORITY||Treatment difference|11.2|||<|0.0001|TWO_SIDED|95.0|6.4|15.9||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||15.9|6.4|<0.0001
71861851|NCT02493946|143239070|SUPERIORITY||Treatment difference|8.1||||0.0004|TWO_SIDED|95.0|3.7|12.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||12.6|3.7|0.0004
71861852|NCT02493946|143239071|SUPERIORITY||Treatment difference|-0.6||||0.0174|TWO_SIDED|95.0|-1.1|-0.1||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 8 Cycle 1.||-0.1|-1.1|0.0174
71861853|NCT02493946|143239071|SUPERIORITY||Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.7|-0.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 29 Cycle 1.||-0.6|-1.7|<0.0001
71861854|NCT02493946|143239071|SUPERIORITY||Treatment difference|-1.4||||0.0001|TWO_SIDED|95.0|-2.0|-0.7||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 57 Cycle 1.||-0.7|-2.0|0.0001
71861855|NCT02493946|143239071|SUPERIORITY||Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.1|-0.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution - Placebo) at Day 85 Cycle 1.||-0.8|-2.1|<0.0001
71861856|NCT01727505|143239088|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon signed rank test|||||||0.44
71861857|NCT01727505|143239089|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon signed rank test|||||||.75
71861858|NCT01727505|143239090|SUPERIORITY_OR_OTHER|||||||0.2|||||||Wilcoxon signed rank test|||||||0.2
71861859|NCT01727505|143239091|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon signed rank test|||||||0.02
71861860|NCT01727505|143239092|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon signed rank test|||||||.049
71861861|NCT01727505|143239093|SUPERIORITY_OR_OTHER|||||||0.006|||||||Paired t-test|||||||0.006
71861862|NCT01814072|143239138|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<.001
71861863|NCT01814072|143239139|SUPERIORITY||Estimated Change|0.1244||||0.567|TWO_SIDED|95.0|-0.3026|0.5513|||Mixed Models Analysis|||||.5513|-.3026|0.567
71861864|NCT01814072|143239139|SUPERIORITY||Estimated Change|-0.0226||||0.917|TWO_SIDED|95.0|-0.4495|0.4044|||Mixed Models Analysis|||||.4044|-.4495|0.917
71861865|NCT01814072|143239139|SUPERIORITY||Estimated Change|0.084||||0.699|TWO_SIDED|95.0|-0.3429|0.5109|||Mixed Models Analysis|||||.5109|-.3429|0.699
71861866|NCT01814072|143239139|SUPERIORITY||Estimated Change|0.1081||||0.619|TWO_SIDED|95.0|-0.3188|0.535|||Mixed Models Analysis|||||.5350|-.3188|0.619
71861867|NCT01814072|143239139|SUPERIORITY||Estimated Change|-0.4353||||0.046|TWO_SIDED|95.0|-0.8622|-0.0084|||Mixed Models Analysis|||||-.0084|-.8622|0.046
71861868|NCT01814072|143239140|OTHER||Estimated Change|0.424||||0.051|TWO_SIDED|95.0|-0.002|0.85|||Mixed Models Analysis|||Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.||0.850|-0.002|0.051
71861869|NCT01782690|143239165|SUPERIORITY_OR_OTHER|||||||0.2361|||||||Log Rank|||Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm||||0.2361
71861870|NCT04121897|143239188|OTHER|||||||0.024|||||||t-test, 2 sided|||||||0.024
71861871|NCT01948076|143239205|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
71861872|NCT01948076|143239206|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|95.0|||||McNemar|||||||0.043
71907753|NCT02505542|143337674|OTHER||LS Mean Difference vs Placebo|-0.3|STANDARD_ERROR_OF_MEAN|0.19|=|0.074|TWO_SIDED|95.0|-0.73|0.03|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."||0.03|-0.73|=0.074
71907754|NCT01668030|143337692|SUPERIORITY|||||||0.0853|||||||t-test, 2 sided|||||||.0853
71861873|NCT00078377|143239320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.0024||95.0|1.02|4.61|||ANCOVA|The corresponding baseline value as a covariate.||Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group||4.61|1.02|0.0024
71861874|NCT00078377|143239321|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71861875|NCT00581893|143239322|SUPERIORITY|||||||0.5|||||||McNemar|||||||0.50
71861876|NCT00233480|143239323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED|95.0|||||paired t test|||||||0.025
71861877|NCT00790400|143239331|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Clopper-Pearson|||||||<0.0001
71861878|NCT04292470|143239355|SUPERIORITY|||||||0.41|||||||ANOVA|||||||0.41
71861879|NCT04292470|143239356|SUPERIORITY|||||||0.09|||||||ANOVA|||For statistical testing, we used a general linear model of change in GERD symptoms from baseline to 8 weeks adjusted for the natural log of the index value (of the ratio of the change in skin conductance between patient and physician at baseline) and randomization assignment.||||0.09
71861880|NCT02906020|143239368|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.87|=|0.1679|TWO_SIDED|95.0|-1.1|6.27||The threshold for statistical significance was 0.05.|MMRM|||Least-squares (LS) mean, standard errors (SE) and p-value were estimated from mixed-effect model with repeated measures (MMRM) analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||6.27|-1.10|=0.1679
71861881|NCT02906020|143239369|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|1.85|=|0.5996|TWO_SIDED|95.0|-4.63|2.68||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time point interaction.||2.68|-4.63|=0.5996
71861882|NCT02906020|143239370|SUPERIORITY||LS mean difference|4.13|STANDARD_ERROR_OF_MEAN|2.13|=|0.0535|TWO_SIDED|95.0|-0.06|8.32||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value were estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction||8.32|-0.06|=0.0535
71861883|NCT02906020|143239371|SUPERIORITY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.08|=|0.74|TWO_SIDED|95.0|-0.12|0.17||The threshold for statistical significance was 0.05.|MMRM|||LS mean, SE and P-value: estimated from MMRM analysis which included fixed categorical effects of treatment group, randomization strata, time point, treatment-by-time point and strata-by-time point interaction and continuous fixed covariates Baseline value and Baseline value-by-time-interaction.||0.17|-0.12|=0.7400
71861884|NCT01634269|143239388|SUPERIORITY_OR_OTHER_LEGACY||Proportion of IF implanted subjects|87.5||||0.002|TWO_SIDED|95.0|61.7|98.4|||Exact binomial|||||98.4|61.7|0.002
71861885|NCT01607879|143239472|SUPERIORITY|||||||0.1497|||||||t-test, 1 sided|||||||0.1497
71861886|NCT01607879|143239473|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.17
71861887|NCT01607879|143239474|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||0.75
71861888|NCT01607879|143239475|SUPERIORITY|||||||0.925|||||||Wilcoxon (Mann-Whitney)|||||||0.925
71861889|NCT01607879|143239476|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71907755|NCT00618995|143337693|NON_INFERIORITY_OR_EQUIVALENCE|Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|0.97||||||90.0|0.8|1.18||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.18|0.8|
71907756|NCT00618995|143337693|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.77|1.14||||||||1.14|0.77|
71907757|NCT00618995|143337693|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.05||||||||1.05|0.71|
71907758|NCT00618995|143337693|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.84||||||90.0|0.69|1.02||||||||1.02|0.69|
71907759|NCT00618995|143337693|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.92||||||90.0|0.76|1.13||||||||1.13|0.76|
71907760|NCT00618995|143337693|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.9||||||90.0|0.74|1.09||||||||1.09|0.74|
71907761|NCT00618995|143337694|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.06||||||||1.06|0.84|
71907762|NCT00618995|143337694|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.05||||||||1.05|0.84|
71907763|NCT00618995|143337694|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
71907764|NCT00618995|143337694|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.54||||||90.0|0.48|0.6||||||||0.60|0.48|
71907765|NCT00618995|143337694|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.6||||||90.0|0.54|0.67||||||||0.67|0.54|
71907766|NCT00618995|143337694|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64||||||||0.64|0.51|
71907767|NCT01522443|143337695|SUPERIORITY_OR_OTHER|||||||0.773|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||0.773
71907768|NCT01522443|143337696|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||||<0.001
71907769|NCT01522443|143337697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.121|TWO_SIDED|95.0|0.44|1.1|||Log Rank|The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.||||1.10|0.44|0.121
71907770|NCT02940626|143337734|OTHER|||||||0.547|||||||Wald Test on equality of proportions|||Subjects were analyzed for efficacy in the group to which they randomized. Sponsor defined outcomes were based on review of microbiology results from samples tested at the central lab. If sample was not sent to the central lab., determination was based on results from the local microbiology lab. In cases where both local \& central lab results were available, concordance was confirmed for S. aureus. Therefore, the analysis used local microbiology data in order to utilize a more complete dataset.||||.5470
71907771|NCT01802554|143337754|SUPERIORITY_OR_OTHER|||||||0.039|||||||Mixed Models Analysis|||||||.039
71907772|NCT01802554|143337755|SUPERIORITY_OR_OTHER|||||||0.701|||||||Mixed Models Analysis|||||||.701
71907773|NCT01802554|143337756|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
71907774|NCT01802554|143337757|SUPERIORITY_OR_OTHER|||||||0.268|||||||Mixed Models Analysis|||||||.268
71907775|NCT01802554|143337758|SUPERIORITY_OR_OTHER|||||||0.021|||||||Mixed Models Analysis|||||||.021
71907776|NCT01167582|143337762|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 1 Post Randomization||||<0.001
71907777|NCT01167582|143337762|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 2 Post Randomization||||<0.001
71907778|NCT01167582|143337762|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Day 3 Post Randomization||||<0.001
71907779|NCT01167582|143337763|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71907780|NCT01167582|143337764|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.38|||||TWO_SIDED|95.0|0.99|5.73|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||5.73|0.99|
71907781|NCT01167582|143337765|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.7||||||95.0|-5.3|24.7|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|||24.7|-5.3|
71907782|NCT01167582|143337766|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|7.13|||||TWO_SIDED|95.0|0.91|56.02|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Mortality||56.02|0.91|
71907783|NCT01167582|143337766|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.48|4.22|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Myocardial Infarction||4.22|0.48|
71907784|NCT00094887|143337803|OTHER||||||=|0.8085|||||||Wilcoxon (Mann-Whitney)|||||||= 0.8085
71907785|NCT01714817|143337830|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.08||||0.7264|TWO_SIDED|95.0|0.7077|1.6421|||Stratified logistic regression||Abatacept IV:Placebo IV 95%CI for Odds Ratio|||1.6421|0.7077|0.7264
71907786|NCT01714817|143337831|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.4148|1.5956|||||Abatacept IV:Placebo IV|||1.5956|0.4148|
71907787|NCT01714817|143337832|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.17||||0.571|TWO_SIDED|95.0|-0.76|0.42|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.42|-0.76|0.571
71907788|NCT01714817|143337833|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-0.09||||0.561|TWO_SIDED|95.0|-0.41|0.22|||Mixed Models Analysis||Adjusted mean difference from placebo|||0.22|-0.41|0.561
71907789|NCT01714817|143337836|SUPERIORITY||Estimate of Difference|1.651|||||TWO_SIDED|95.0|-7.595828|10.897784||||||CR - Day 365||10.897784|-7.595828|
71907790|NCT01714817|143337836|SUPERIORITY||Estimate of Difference|-0.8828|||||TWO_SIDED|95.0|-8.848056|7.082461||||||PR - Day 365||7.082461|-8.848056|
71907791|NCT01714817|143337836|SUPERIORITY||Estimate of Difference|-0.7682|||||TWO_SIDED|95.0|-10.446714|8.910353||||||NR - Day 365||8.910353|-10.446714|
71907792|NCT01714817|143337845|SUPERIORITY|Day 365|Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.3251|6.2849||||||||6.2849|0.3251|
71907793|NCT01714817|143337845|SUPERIORITY|Day 729|Estimate of Difference vs Drug|3.4|||||TWO_SIDED|95.0|-8.4|15.1||||||||15.1|-8.4|
71907794|NCT01714817|143337865|SUPERIORITY||Estimate of Difference|-0.9682|||||TWO_SIDED|95.0|-4.760178|2.823876||||||Lupus treatment failure - Day 365||2.823876|-4.760178|
71907795|NCT01714817|143337865|SUPERIORITY||Estimate of Difference|-0.4707|||||TWO_SIDED|95.0|-4.588691|3.647365||||||Overall treatment failure - Day 365||3.647365|-4.588691|
71907796|NCT01714817|143337865|SUPERIORITY|Lupus treatment failure - Day 729|Estimate of Difference|0.8|||||TWO_SIDED|95.0|-4.5|6.1||||||||6.1|-4.5|
71681557|NCT02987972|142881456|OTHER||Difference in Percentages|2.0|||||TWO_SIDED|95.0|-0.7|5.0||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||5.0|-0.7|
71861890|NCT03994731|143239479|SUPERIORITY||Stratified difference in proportions|32.31|STANDARD_ERROR_OF_MEAN|8.157|<|0.0001|TWO_SIDED|95.0|16.3|48.3||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (Pegloticase+MTX - Pegloticase+Placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tophi presence at baseline: yes, no) were combined with Cochran-Mantel-Haenszel (CMH) weights.|||48.3|16.3|< 0.0001
71861891|NCT03994731|143239480|SUPERIORITY||response rate difference|29.05|STANDARD_ERROR_OF_MEAN|8.084||0.0003|TWO_SIDED|95.0|13.2|44.9||The 2-sided p-value was calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||response rate difference (Peg+MTX - Peg+Placebo)|||44.9|13.2|0.0003
71861892|NCT03994731|143239481|SUPERIORITY||Difference|22.8||||0.0482|TWO_SIDED|95.0|1.2|44.4||The comparison of complete response between groups is performed using an unstratified chi-squared test.|Chi-squared||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||44.4|1.2|0.0482
71861893|NCT03994731|143239482|SUPERIORITY||Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.084||0.6287|TWO_SIDED|95.0|-0.21|0.13||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||0.13|-0.21|0.6287
71861894|NCT03994731|143239483|SUPERIORITY||Difference|-8.43|STANDARD_ERROR_OF_MEAN|3.766||0.0272|TWO_SIDED|95.0|-15.88|-0.97||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-0.97|-15.88|0.0272
71907797|NCT01714817|143337865|SUPERIORITY|Overall treatment failure - Day 729|Estimate of Difference|2.7|||||TWO_SIDED|95.0|-3.3|8.8||||||||8.8|-3.3|
71907798|NCT02921763|143337875|SUPERIORITY||||||=|0.0533|||||||Sign test|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst, the values before treatment initiation and at last observation were compared, frequency of increase and decrease was summarized and the sign test was performed separately in the efficacy analysis set and study completers."||||=0.0533
71907799|NCT02921763|143337877|SUPERIORITY||||||=|0.7328|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.7328
71922077|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-1.87|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-10.09|6.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.35|-10.09|
71681558|NCT02987972|142881457|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
71861895|NCT03994731|143239484|SUPERIORITY||Difference|-10.16|STANDARD_ERROR_OF_MEAN|2.531||0.0222|TWO_SIDED|95.0|-18.84|-1.48||Based on mixed models repeated measures (MMRM) analysis of covariance (ANCOVA) model including the following terms: baseline value, tophi presence (Y/N), treatment group, visit, visit-by-treatment interaction, and visit-by-baseline value interaction.|MMRM ANCOVA||Difference (Pegloticase+MTX - Pegloticase+Placebo)|||-1.48|-18.84|0.0222
71861896|NCT03812029|143239496|SUPERIORITY|||||||0.0015||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0015
71861897|NCT03812029|143239496|SUPERIORITY|||||||0.0121||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0121
71861898|NCT03812029|143239496|SUPERIORITY|||||||0.0371||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0371
71861899|NCT03812029|143239497|SUPERIORITY|||||||0.003||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.003
71861900|NCT03812029|143239497|SUPERIORITY|||||||0.04||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.04
71861901|NCT03812029|143239498|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.0017
71861902|NCT03812029|143239498|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
71861903|NCT03812029|143239498|SUPERIORITY|||||||0.13||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.13
71861904|NCT03812029|143239499|SUPERIORITY|||||||0.001||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.001
71861905|NCT03812029|143239499|SUPERIORITY|||||||0.002||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.002
71861906|NCT03812029|143239499|SUPERIORITY|||||||0.018||||||a priori threshold for statistical significance : \<0.05.|ANCOVA|||||||0.018
71861907|NCT03812029|143239500|SUPERIORITY|||||||0.09||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.09
71861908|NCT03812029|143239500|SUPERIORITY|||||||0.47||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.47
71861909|NCT03812029|143239500|SUPERIORITY|||||||0.14||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.14
71861910|NCT03812029|143239501|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
71861911|NCT03812029|143239501|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||<0.0001
71861912|NCT03812029|143239501|SUPERIORITY|||||||0.0002||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0002
71861913|NCT03812029|143239502|SUPERIORITY|||||||0.017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.017
71861914|NCT03812029|143239502|SUPERIORITY|||||||0.0006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0006
71861915|NCT03812029|143239502|SUPERIORITY|||||||0.006||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.006
71861916|NCT03812029|143239503|SUPERIORITY|||||||0.16||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.16
71861917|NCT03812029|143239503|SUPERIORITY|||||||0.01||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.01
71861918|NCT03812029|143239503|SUPERIORITY|||||||0.57||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.57
71861919|NCT03812029|143239504|SUPERIORITY|||||||0.0017||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0017
71861920|NCT03812029|143239504|SUPERIORITY|||||||0.0093||||||a priori threshold for statistical significance : \<0.05.|Mixed Models Analysis|||||||0.0093
71861921|NCT00790205|143239515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.88|1.09|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.09|0.88|<0.001
71861922|NCT00790205|143239516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|TWO_SIDED|95.0|0.89|1.08|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.08|0.89|<0.001
71861923|NCT00790205|143239517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.11|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.11|0.89|<0.001
71861924|NCT00790205|143239518|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|TWO_SIDED|95.0|0.89|1.1|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||1.10|0.89|<0.001
71861925|NCT00790205|143239519|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.06||||0.435|TWO_SIDED|95.0|0.91|1.24|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.24|0.91|0.435
71861926|NCT00790205|143239520|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.875|TWO_SIDED|95.0|0.9|1.14|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.14|0.90|0.875
71861927|NCT00790205|143239521|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.81|1.19|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.19|0.81|0.858
71861928|NCT00790205|143239522|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.983|TWO_SIDED|95.0|0.83|1.2|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.||1.20|0.83|0.983
71861929|NCT00790205|143239529|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.001|TWO_SIDED|95.0|0.61|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.61|<0.001
71861930|NCT00790205|143239530|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.79|0.63|<0.001
71861931|NCT00790205|143239531|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7|||<|0.001|TWO_SIDED|95.0|0.65|0.75|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.75|0.65|<0.001
71861932|NCT00790205|143239532|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.72|||<|0.001|TWO_SIDED|95.0|0.68|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.||||0.77|0.68|<0.001
71861933|NCT04937920|143239533|OTHER||Mean Paired Change from Baseline|-29620.0||||0.2|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.2
71861934|NCT04937920|143239533|OTHER||Mean Paired Change from Baseline|127195.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
71861935|NCT04937920|143239533|OTHER||Mean Paired Change from Baseline|-41659.0||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||0.6
71681559|NCT02987972|142881457|OTHER||Difference in Percentages|0.3|||||TWO_SIDED|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.||1.6|-0.8|
71681560|NCT02987972|142881458|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.3|12.8|||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||12.8|-0.3|
71681561|NCT02987972|142881458|OTHER||Difference in Percentages|6.3|||||TWO_SIDED|95.0|-0.2|12.9|||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||12.9|-0.2|
71681562|NCT02987972|142881459|OTHER||Difference in Percentages|0.7||||0.772|TWO_SIDED|95.0|-3.9|5.2|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.|||5.2|-3.9|0.772
71681563|NCT02987972|142881459|OTHER||Difference in Percentages|2.6||||0.235|TWO_SIDED|95.0|-1.7|7.0|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.|||7.0|-1.7|0.235
71681564|NCT02987972|142881460|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.62|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.76|0.62|
71861936|NCT04937920|143239533|OTHER||Mean Paired Change from Baseline|-483.0||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.||||1.0
71861937|NCT04092452|143239554|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|9.69||0.4696|TWO_SIDED|90.0|-15.2|16.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||16.7|-15.2|0.4696
71861938|NCT04092452|143239554|SUPERIORITY||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|9.71||0.0298|TWO_SIDED|90.0|2.7|34.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||34.6|2.7|0.0298
71861939|NCT04092452|143239554|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.79||0.3606|TWO_SIDED|90.0|-12.6|19.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.||19.6|-12.6|0.3606
71861940|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|7.19|||TWO_SIDED|90.0|-15.6|8.0||||||Week 1||8.0|-15.6|
71861941|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|7.28|||TWO_SIDED|90.0|-12.9|11.1||||||Week 1||11.1|-12.9|
71861942|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|7.99|||TWO_SIDED|90.0|-8.5|17.8||||||Week 1||17.8|-8.5|
71861943|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|7.9|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|90.0|-6.9|22.8||||||Week 2||22.8|-6.9|
71861944|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|8.91|||TWO_SIDED|90.0|-7.1|22.2||||||Week 2||22.2|-7.1|
71861945|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|3.5|STANDARD_ERROR_OF_MEAN|9.0|||TWO_SIDED|90.0|-11.3|18.3||||||Week 2||18.3|-11.3|
71861946|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|9.0|STANDARD_ERROR_OF_MEAN|9.79|||TWO_SIDED|90.0|-7.1|25.1||||||Week 4||25.1|-7.1|
71861947|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|9.57|||TWO_SIDED|90.0|-8.0|23.5||||||Week 4||23.5|-8.0|
71861948|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|9.37|||TWO_SIDED|90.0|-19.4|11.4||||||Week 4||11.4|-19.4|
71861949|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|0.8|STANDARD_ERROR_OF_MEAN|9.96|||TWO_SIDED|90.0|-15.6|17.2||||||Week 6||17.2|-15.6|
71861950|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|6.7|STANDARD_ERROR_OF_MEAN|9.81|||TWO_SIDED|90.0|-9.4|22.9||||||Week 6||22.9|-9.4|
71861951|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|3.7|STANDARD_ERROR_OF_MEAN|10.05|||TWO_SIDED|90.0|-12.8|20.2||||||Week 6||20.2|-12.8|
71861952|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-7.8|STANDARD_ERROR_OF_MEAN|9.98||0.7798|TWO_SIDED|90.0|-24.2|8.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||8.7|-24.2|0.7798
71681565|NCT02987972|142881460|OTHER||GMC Ratio|2.0|||||TWO_SIDED|95.0|1.75|2.28|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.28|1.75|
71681566|NCT02987972|142881460|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.86|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.07|0.86|
71861953|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|9.92||0.4819|TWO_SIDED|90.0|-15.9|16.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||16.8|-15.9|0.4819
71861954|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-2.4|STANDARD_ERROR_OF_MEAN|10.19||0.5933|TWO_SIDED|90.0|-19.2|14.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||14.4|-19.2|0.5933
71861955|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-9.9|STANDARD_ERROR_OF_MEAN|9.81||0.8421|TWO_SIDED|90.0|-26.1|6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||6.2|-26.1|0.8421
71861956|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|8.0|STANDARD_ERROR_OF_MEAN|9.85||0.209|TWO_SIDED|90.0|-8.2|24.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||24.2|-8.2|0.2090
71861957|NCT04092452|143239555|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|10.12||0.5183|TWO_SIDED|90.0|-17.1|16.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.2|-17.1|0.5183
71861958|NCT04092452|143239556|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|7.54||0.515|TWO_SIDED|90.0|-12.7|12.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||12.1|-12.7|0.5150
71861959|NCT04092452|143239556|SUPERIORITY||Risk Difference (RD)|12.2|STANDARD_ERROR_OF_MEAN|8.28||0.0737|TWO_SIDED|90.0|-1.4|25.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||25.8|-1.4|0.0737
71861960|NCT04092452|143239556|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|8.11||0.2081|TWO_SIDED|90.0|-6.7|20.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0 or 1||20.0|-6.7|0.2081
71861961|NCT04092452|143239556|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|8.9||0.2957|TWO_SIDED|90.0|-9.9|19.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||19.4|-9.9|0.2957
71861962|NCT04092452|143239556|SUPERIORITY||Risk Difference (RD)|15.6|STANDARD_ERROR_OF_MEAN|9.07||0.0456|TWO_SIDED|90.0|0.7|30.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||30.5|0.7|0.0456
71861963|NCT04092452|143239556|SUPERIORITY||Risk Difference (RD)|9.2|STANDARD_ERROR_OF_MEAN|9.05||0.1558|TWO_SIDED|90.0|-5.7|24.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Total AN Count of 0, 1 or 2||24.1|-5.7|0.1558
71861964|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-11.98|STANDARD_ERROR_OF_MEAN|8.622|||TWO_SIDED|90.0|-26.16|2.2||||||Week 1||2.20|-26.16|
71861965|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|8.526|||TWO_SIDED|90.0|-29.09|-1.04||||||Week 1||-1.04|-29.09|
71861966|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-17.45|STANDARD_ERROR_OF_MEAN|8.758|||TWO_SIDED|90.0|-31.86|-3.05||||||Week 1||-3.05|-31.86|
71861967|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|9.465|||TWO_SIDED|90.0|-28.09|3.05||||||Week 2||3.05|-28.09|
71861968|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-2.86|STANDARD_ERROR_OF_MEAN|9.338|||TWO_SIDED|90.0|-18.22|12.5||||||Week 2||12.50|-18.22|
71861969|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-5.5|STANDARD_ERROR_OF_MEAN|9.438|||TWO_SIDED|90.0|-21.02|10.03||||||Week 2||10.03|-21.02|
71907800|NCT02921763|143337877|SUPERIORITY||||||=|0.1193|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.1193
71907801|NCT02921763|143337878|SUPERIORITY|||||||0.7221|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.7221
71688734|NCT03749109|142892877|OTHER||Difference in LS mean|-17.66||||0.47|TWO_SIDED|95.0|-66.3|30.98|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 2||30.98|-66.30|0.47
71861970|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-4.52|STANDARD_ERROR_OF_MEAN|11.214|||TWO_SIDED|90.0|-22.96|13.93||||||Week 4||13.93|-22.96|
71861971|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-17.54|STANDARD_ERROR_OF_MEAN|11.131|||TWO_SIDED|90.0|-35.84|0.77||||||Week 4||0.77|-35.84|
71861972|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-3.92|STANDARD_ERROR_OF_MEAN|11.507|||TWO_SIDED|90.0|-22.85|15.0||||||Week 4||15.00|-22.85|
71861973|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|7.09|STANDARD_ERROR_OF_MEAN|13.452|||TWO_SIDED|90.0|-15.04|29.22||||||Week 6||29.22|-15.04|
71861974|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-14.57|STANDARD_ERROR_OF_MEAN|13.688|||TWO_SIDED|90.0|-37.08|7.95||||||Week 6||7.95|-37.08|
71861975|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-8.95|STANDARD_ERROR_OF_MEAN|13.808|||TWO_SIDED|90.0|-31.66|13.76||||||Week 6||13.76|-31.66|
71681567|NCT02987972|142881460|OTHER||GMC Ratio|0.87|||||TWO_SIDED|95.0|0.78|0.96|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.96|0.78|
71681568|NCT02987972|142881460|OTHER||GMC Ratio|0.57|||||TWO_SIDED|95.0|0.5|0.65|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.65|0.50|
71681569|NCT02987972|142881460|OTHER||GMC Ratio|1.21|||||TWO_SIDED|95.0|1.06|1.39|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.39|1.06|
71681570|NCT02987972|142881460|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.82|0.67|
71681571|NCT02987972|142881460|OTHER||GMC Ratio|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.95|0.74|
71861976|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|11.5|STANDARD_ERROR_OF_MEAN|13.057||0.8108|TWO_SIDED|90.0|-9.98|32.98||One-sided p-value|ANCOVA|||Week 8||32.98|-9.98|0.8108
71861977|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-16.15|STANDARD_ERROR_OF_MEAN|12.845||0.1043|TWO_SIDED|90.0|-37.28|4.98||One-sided p-value|ANCOVA|||Week 8||4.98|-37.28|0.1043
71861978|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-15.07|STANDARD_ERROR_OF_MEAN|13.355||0.1296|TWO_SIDED|90.0|-37.04|6.9||One-sided p-value|ANCOVA|||Week 8||6.90|-37.04|0.1296
71907802|NCT02921763|143337878|SUPERIORITY|||||||0.0861|||||||Wilcoxon (Mann-Whitney)|||"For the volume calculated from the major and minor axes of ovarian chocolate cyst (a total volume if there were two or more cysts), the value, difference from the value before treatment and change rate were calculated using the summary statistics at each measurement point and last observation in each analysis set, namely efficacy analysis set and study completers, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||0.0861
71907803|NCT02921763|143337882|SUPERIORITY||||||=|0.002|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0020
71861979|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-6.54|STANDARD_ERROR_OF_MEAN|16.384||0.345|TWO_SIDED|90.0|-33.49|20.42||One-sided p-value|ANCOVA|||Week 12||20.42|-33.49|0.3450
71861980|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-17.18|STANDARD_ERROR_OF_MEAN|14.116||0.1119|TWO_SIDED|90.0|-40.4|6.04||One-sided p-value|ANCOVA|||Week 12||6.04|-40.40|0.1119
71861981|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-19.99|STANDARD_ERROR_OF_MEAN|14.806||0.0885|TWO_SIDED|90.0|-44.34|4.37||One-sided p-value|ANCOVA|||Week 12||4.37|-44.34|0.0885
71861982|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|10.85|STANDARD_ERROR_OF_MEAN|20.14||0.705|TWO_SIDED|90.0|-22.28|43.98||One-sided p-value|ANCOVA|||Week 16||43.98|-22.28|0.7050
71861983|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-17.62|STANDARD_ERROR_OF_MEAN|19.519||0.1833|TWO_SIDED|90.0|-49.73|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-49.73|0.1833
71861984|NCT04092452|143239557|SUPERIORITY||Risk Difference (RD)|-9.41|STANDARD_ERROR_OF_MEAN|20.277||0.3213|TWO_SIDED|90.0|-42.76|23.94||One-sided p-value|ANCOVA|||Week 16||23.94|-42.76|0.3213
71907804|NCT02921763|143337882|SUPERIORITY||||||=|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||=0.0001
71907805|NCT02921763|143337882|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
71907806|NCT02921763|143337882|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
71681572|NCT02987972|142881460|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.76|0.58|
71681573|NCT02987972|142881460|OTHER||GMC Ratio|0.8|||||TWO_SIDED|95.0|0.72|0.9||||||Type 18C|IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|0.90|0.72|
71861985|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
71861986|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|2.6|||TWO_SIDED|90.0|-6.3|2.2||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.2|-6.3|
71861987|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-5.9|2.9||||||Week 1 - Statistical Analysis (MI) - Absolute Score||2.9|-5.9|
71861988|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|2.59|||TWO_SIDED|90.0|-5.2|3.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||3.3|-5.2|
71861989|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|90.0|-4.3|4.1||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.1|-4.3|
71861990|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|90.0|-4.3|4.3||||||Week 2 - Statistical Analysis (MI) - Absolute Score||4.3|-4.3|
71861991|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|90.0|-4.5|3.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||3.8|-4.5|
71861992|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|90.0|-5.4|2.8||||||Week 4 - Statistical Analysis (MI) - Absolute Score||2.8|-5.4|
71907807|NCT02921763|143337882|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The score value and difference from the value before treatment were calculated at the same points using the summary statistics, and the Wilcoxon signed-rank test was performed.||||<0.0001
71907808|NCT02921763|143337883|SUPERIORITY||||||=|0.0024|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0024
71907809|NCT02921763|143337883|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907810|NCT02921763|143337883|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907811|NCT02921763|143337883|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907812|NCT02921763|143337883|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907813|NCT02921763|143337884|SUPERIORITY||||||=|0.0037|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0037
71907814|NCT02921763|143337884|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907815|NCT02921763|143337884|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907816|NCT02921763|143337884|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||<0.0001
71907817|NCT02921763|143337884|SUPERIORITY||||||=|0.0003|||||||Wilcoxon (Mann-Whitney)|||The difference from the value before treatment and change rate were calculated using the summary statistics at each observation point and last observation, and the Wilcoxon signed-rank test was performed for the difference and change rate.||||=0.0003
71907818|NCT02921763|143337885|SUPERIORITY||||||=|0.8035|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8035
71907819|NCT02921763|143337886|SUPERIORITY||||||=|0.8185|||||||Wilcoxon (Mann-Whitney)|||"Separately in the efficacy analysis set and study completers, the values before treatment initiation and at last observation were compared, the value, difference from the value before treatment and change rate were calculated using the summary statistics, and the Wilcoxon signed-rank test was performed for the difference and change rate."||||=0.8185
71907820|NCT02007954|143337905|OTHER|||||||0.01||||||P-values \< 0.05 considered statistically significant.|t-test, 2 sided|||Shapiro-Wilk test was run for normality. Baseline and follow-up AFP compared using two-tailed Student's t-test.||||.01
71907821|NCT02659605|143337912|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.572|||||||Student's t-test|||||||0.572
71907822|NCT02659605|143337913|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.849|||||||Student's t-test|||||||0.849
71907823|NCT02659605|143337914|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.886|||||||Student's t-test|||||||0.886
71907824|NCT02659605|143337915|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.612|||||||Student's t-test|||||||0.612
71907825|NCT02659605|143337916|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.728|||||||Student's t-test|||||||0.728
71907826|NCT02659605|143337917|EQUIVALENCE|The sample size was based on a previous study by Rabe et al. (Obstet Gynecol. 2011;117(2 Pt 1):205-11), who were also evaluating neonatal hematocrit after delayed cord clamping with the intention of detecting a 10% difference with a p-value of 0.05 and a power of 80% for a two-sided t-test. That study determined that 26 patients in each group were needed for a total of 52 subjects.||||||0.584|||||||Student's t-test|||||||0.584
71681574|NCT02987972|142881460|OTHER||GMC Ratio|0.79|||||TWO_SIDED|95.0|0.69|0.91|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.91|0.69|
71681575|NCT02987972|142881460|OTHER||GMC Ratio|0.74|||||TWO_SIDED|95.0|0.65|0.85|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.85|0.65|
71861993|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-4.5|STANDARD_ERROR_OF_MEAN|2.58|||TWO_SIDED|90.0|-8.8|-0.3||||||Week 4 - Statistical Analysis (MI) - Absolute Score||-0.3|-8.8|
71861994|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-1.6|STANDARD_ERROR_OF_MEAN|2.99|||TWO_SIDED|90.0|-6.5|3.3||||||Week 6 - Statistical Analysis (MI) - Absolute Score||3.3|-6.5|
71688735|NCT03749109|142892877|OTHER||Difference in LS mean|25.61||||0.27|TWO_SIDED|95.0|-21.05|72.27|||ANCOVA|ANCOVA adjusted for baseline lesion size.||DIE at cycle 4||72.27|-21.05|0.27
71861995|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-4.7|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|90.0|-9.5|0.1||||||Week 6 - Statistical Analysis (MI) - Absolute Score||0.1|-9.5|
71861996|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-5.4|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|90.0|-10.5|-0.4||||||Week 6 - Statistical Analysis (MI) - Absolute Score||-0.4|-10.5|
71861997|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|1.0|STANDARD_ERROR_OF_MEAN|2.78||0.6393|TWO_SIDED|90.0|-3.6|5.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||5.6|-3.6|0.6393
71861998|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|2.72||0.5178|TWO_SIDED|90.0|-4.4|4.6||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||4.6|-4.4|0.5178
71861999|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-3.8|STANDARD_ERROR_OF_MEAN|2.82||0.0864|TWO_SIDED|90.0|-8.5|0.8||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Absolute Score||0.8|-8.5|0.0864
71862000|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|2.61||0.3172|TWO_SIDED|90.0|-5.5|3.1||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||3.1|-5.5|0.3172
71862001|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-2.7|STANDARD_ERROR_OF_MEAN|2.51||0.1384|TWO_SIDED|90.0|-6.8|1.4||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.4|-6.8|0.1384
71862002|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-2.8|STANDARD_ERROR_OF_MEAN|2.66||0.1427|TWO_SIDED|90.0|-7.2|1.5||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Absolute Score||1.5|-7.2|0.1427
71862003|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-2.5|STANDARD_ERROR_OF_MEAN|2.99||0.1975|TWO_SIDED|90.0|-7.5|2.4||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.4|-7.5|0.1975
71862004|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|2.76||0.0755|TWO_SIDED|90.0|-8.5|0.6||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||0.6|-8.5|0.0755
71862005|NCT04092452|143239558|SUPERIORITY||Risk Difference (RD)|-2.6|STANDARD_ERROR_OF_MEAN|2.89||0.1869|TWO_SIDED|90.0|-7.3|2.2||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Absolute Score||2.2|-7.3|0.1869
71862006|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-3.65|STANDARD_ERROR_OF_MEAN|8.659|||TWO_SIDED|90.0|-17.9|10.59||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||10.59|-17.90|
71862007|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-13.77|STANDARD_ERROR_OF_MEAN|8.749|||TWO_SIDED|90.0|-28.16|0.62||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||0.62|-28.16|
71862008|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-17.51|STANDARD_ERROR_OF_MEAN|8.752|||TWO_SIDED|90.0|-31.91|-3.12||||||Week 1 - Statistical Analysis (MI) - Percent Change from Baseline||-3.12|-31.91|
71862009|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-4.29|STANDARD_ERROR_OF_MEAN|10.103|||TWO_SIDED|90.0|-20.91|12.33||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||12.33|-20.91|
71862010|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-2.05|STANDARD_ERROR_OF_MEAN|9.904|||TWO_SIDED|90.0|-18.34|14.24||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||14.24|-18.34|
71862011|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|0.17|STANDARD_ERROR_OF_MEAN|10.039|||TWO_SIDED|90.0|-16.34|16.68||||||Week 2 - Statistical Analysis (MI) - Percent Change from Baseline||16.68|-16.34|
71862012|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|10.227|||TWO_SIDED|90.0|-17.29|16.36||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||16.36|-17.29|
71862013|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-8.07|STANDARD_ERROR_OF_MEAN|10.155|||TWO_SIDED|90.0|-24.77|8.63||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||8.63|-24.77|
71862014|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-6.06|STANDARD_ERROR_OF_MEAN|10.509|||TWO_SIDED|90.0|-23.35|11.22||||||Week 4 - Statistical Analysis (MI) - Percent Change from Baseline||11.22|-23.35|
71862015|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-3.54|STANDARD_ERROR_OF_MEAN|12.262|||TWO_SIDED|90.0|-23.71|16.63||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||16.63|-23.71|
71862016|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-16.26|STANDARD_ERROR_OF_MEAN|12.51|||TWO_SIDED|90.0|-36.84|4.32||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||4.32|-36.84|
71862017|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-12.52|STANDARD_ERROR_OF_MEAN|12.61|||TWO_SIDED|90.0|-33.27|8.22||||||Week 6 - Statistical Analysis (MI) - Percent Change from Baseline||8.22|-33.27|
71862018|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|5.79|STANDARD_ERROR_OF_MEAN|11.045||0.7|TWO_SIDED|90.0|-12.38|23.96||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||23.96|-12.38|0.7000
71862019|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-5.81|STANDARD_ERROR_OF_MEAN|10.876||0.2965|TWO_SIDED|90.0|-23.7|12.08||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||12.08|-23.70|0.2965
71862020|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-11.33|STANDARD_ERROR_OF_MEAN|11.247||0.1568|TWO_SIDED|90.0|-29.83|7.17||One-sided p-value|ANCOVA|||Week 8 - Statistical Analysis (MI) - Percent Change from Baseline||7.17|-29.83|0.1568
71862021|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-6.78|STANDARD_ERROR_OF_MEAN|10.912||0.2672|TWO_SIDED|90.0|-24.73|11.17||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||11.17|-24.73|0.2672
71681576|NCT02987972|142881460|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.07|0.79|
71681577|NCT02987972|142881460|OTHER||GMC Ratio|27.82|||||TWO_SIDED|95.0|24.64|31.4|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|type 22F||31.40|24.64|
71862022|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-16.57|STANDARD_ERROR_OF_MEAN|10.517||0.0576|TWO_SIDED|90.0|-33.87|0.73||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||0.73|-33.87|0.0576
71681578|NCT02987972|142881460|OTHER||GMC Ratio|25.57|||||TWO_SIDED|95.0|22.61|28.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||28.92|22.61|
71681579|NCT02987972|142881460|OTHER||GMC ratio|0.77|||||TWO_SIDED|95.0|0.69|0.85|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.85|0.69|
71681580|NCT02987972|142881460|OTHER||GMC Ratio|2.1|||||TWO_SIDED|95.0|1.84|2.39|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||2.39|1.84|
71681581|NCT02987972|142881460|OTHER||GMC Ratio|0.94|||||TWO_SIDED|95.0|0.85|1.05|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.05|0.85|
71681582|NCT02987972|142881460|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.77|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.95|0.77|
71681583|NCT02987972|142881460|OTHER||GMC Ratio|0.65|||||TWO_SIDED|95.0|0.57|0.74|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.74|0.57|
71681584|NCT02987972|142881460|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.97|1.28|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.28|0.97|
71681585|NCT02987972|142881460|OTHER||GMC Ratio|0.78|||||TWO_SIDED|95.0|0.7|0.86|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.86|0.70|
71681586|NCT02987972|142881460|OTHER||GMC Ratio|0.86|||||TWO_SIDED|95.0|0.76|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.97|0.76|
71681587|NCT02987972|142881460|OTHER||GMC Ratio|0.61|||||TWO_SIDED|95.0|0.53|0.7|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.70|0.53|
71907827|NCT02373371|143338008|SUPERIORITY|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||"Main analysis:~* nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~* nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0"||||0.8460
71907828|NCT02373371|143338010|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71907829|NCT02373371|143338011|SUPERIORITY|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71681588|NCT02987972|142881460|OTHER||GMC Ratio|1.2|||||TWO_SIDED|95.0|1.07|1.34|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.34|1.07|
71681589|NCT02987972|142881460|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.71|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.94|0.71|
71681590|NCT02987972|142881460|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.73|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||0.94|0.73|
71681591|NCT02987972|142881460|OTHER||GMC Ratio|1.16|||||TWO_SIDED|95.0|0.99|1.35|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.35|0.99|
71681592|NCT02987972|142881460|OTHER||GMC Ratio|26.3|||||TWO_SIDED|95.0|23.31|29.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||29.68|23.31|
71681593|NCT02987972|142881460|OTHER||GMC Ratio|24.1|||||TWO_SIDED|95.0|21.32|27.25|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||27.25|21.32|
71907830|NCT00880763|143338099|SUPERIORITY_OR_OTHER||Adjusted difference in percent|65.1|||<|0.001|TWO_SIDED|95.0|37.0|82.8|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||82.8|37.0|<0.001
71907831|NCT00880763|143338099|SUPERIORITY_OR_OTHER||Adjusted difference in percent|74.5|||<|0.001|TWO_SIDED|95.0|47.6|89.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||89.0|47.6|<0.001
71907832|NCT00880763|143338099|SUPERIORITY_OR_OTHER||Adjusted difference in percent|55.4|||<|0.001|TWO_SIDED|95.0|24.9|76.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).|||76.0|24.9|<0.001
71907833|NCT00880763|143338100|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-11.3|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-11.3|
71862023|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-13.65|STANDARD_ERROR_OF_MEAN|11.603||0.1197|TWO_SIDED|90.0|-32.74|5.44||One-sided p-value|ANCOVA|||Week 12 - Statistical Analysis (MI) - Percent Change from Baseline||5.44|-32.74|0.1197
71862024|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-5.63|STANDARD_ERROR_OF_MEAN|13.545||0.3388|TWO_SIDED|90.0|-27.91|16.65||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||16.65|-27.91|0.3388
71862025|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-14.8|STANDARD_ERROR_OF_MEAN|13.567||0.1376|TWO_SIDED|90.0|-37.12|7.51||One-sided p-value|ANCOVA|||Week 16 - Statistical Analysis (MI) - Percent Change from Baseline||7.51|-37.12|0.1376
71862026|NCT04092452|143239559|SUPERIORITY||Risk Difference (RD)|-8.32|STANDARD_ERROR_OF_MEAN|13.86||0.2741|TWO_SIDED|90.0|-31.12|14.48||One-sided p-value|ANCOVA|||Week 16||14.48|-31.12|0.2741
71862027|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|7.06|||TWO_SIDED|90.0|-13.0|10.3||||||Week 4||10.3|-13.0|
71862028|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|90.0|-18.7|1.8||||||Week 4||1.8|-18.7|
71862029|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|7.55|||TWO_SIDED|90.0|-10.7|14.1||||||Week 4||14.1|-10.7|
71862030|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|6.6|STANDARD_ERROR_OF_MEAN|6.8||0.8372|TWO_SIDED|90.0|-4.6|17.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||17.7|-4.6|0.8372
71862031|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-6.4|STANDARD_ERROR_OF_MEAN|4.68||0.0819|TWO_SIDED|90.0|-14.1|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||1.3|-14.1|0.0819
71862032|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|4.34||0.0242|TWO_SIDED|90.0|-15.2|-0.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||-0.9|-15.2|0.0242
71862033|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-12.7|STANDARD_ERROR_OF_MEAN|6.33||0.0264|TWO_SIDED|90.0|-23.1|-2.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-2.3|-23.1|0.0264
71862034|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-14.5|STANDARD_ERROR_OF_MEAN|6.47||0.0127|TWO_SIDED|90.0|-25.1|-3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-3.9|-25.1|0.0127
71862035|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-16.6|STANDARD_ERROR_OF_MEAN|6.33||0.0059|TWO_SIDED|90.0|-27.0|-6.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||-6.2|-27.0|0.0059
71862036|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-9.6|STANDARD_ERROR_OF_MEAN|7.97||0.1185|TWO_SIDED|90.0|-22.7|3.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||3.5|-22.7|0.1185
71862037|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|6.39||0.004|TWO_SIDED|90.0|-26.6|-5.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-5.6|-26.6|0.0040
71862038|NCT04092452|143239560|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|7.09||0.0418|TWO_SIDED|90.0|-24.5|-1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||-1.1|-24.5|0.0418
71862039|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|12.1|STANDARD_ERROR_OF_MEAN|7.75||0.0559|TWO_SIDED|90.0|-0.7|24.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||24.8|-0.7|0.0559
71862040|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|9.8|STANDARD_ERROR_OF_MEAN|7.09||0.0758|TWO_SIDED|90.0|-1.9|21.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||21.4|-1.9|0.0758
71862041|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|11.3|STANDARD_ERROR_OF_MEAN|7.21||0.0637|TWO_SIDED|90.0|-0.6|23.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Pain at its Worst)||23.2|-0.6|0.0637
71862042|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|4.2|STANDARD_ERROR_OF_MEAN|8.84||0.3179|TWO_SIDED|90.0|-10.3|18.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||18.8|-10.3|0.3179
71862043|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|11.0|STANDARD_ERROR_OF_MEAN|8.82||0.1078|TWO_SIDED|90.0|-3.5|25.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||25.5|-3.5|0.1078
71862044|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|8.86||0.1976|TWO_SIDED|90.0|-7.0|22.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Pain at its Worst)||22.2|-7.0|0.1976
71862045|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-18.9|STANDARD_ERROR_OF_MEAN|9.32||0.9738|TWO_SIDED|90.0|-34.3|-3.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||-3.6|-34.3|0.9738
71688736|NCT03749109|142892877|OTHER||Difference in LS mean|-20.95||||0.41|TWO_SIDED|95.0|-71.83|29.92|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 2||29.92|-71.83|0.41
71681594|NCT02987972|142881461|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.81|0.62|
71681595|NCT02987972|142881461|OTHER||GMC Ratio|1.44|||||TWO_SIDED|95.0|1.27|1.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.63|1.27|
71862046|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|5.8|STANDARD_ERROR_OF_MEAN|10.4||0.2925|TWO_SIDED|90.0|-11.3|22.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||22.9|-11.3|0.2925
71862047|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-3.1|STANDARD_ERROR_OF_MEAN|10.18||0.6178|TWO_SIDED|90.0|-19.8|13.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Pain at its Worst)||13.7|-19.8|0.6178
71681596|NCT02987972|142881461|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||1.02|0.76|
71681597|NCT02987972|142881461|OTHER||GMC Ratio|0.73|||||TWO_SIDED|95.0|0.63|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.84|0.63|
71862048|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-20.9|STANDARD_ERROR_OF_MEAN|10.04||0.9769|TWO_SIDED|90.0|-37.4|-4.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||-4.4|-37.4|0.9769
71862049|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-4.2|STANDARD_ERROR_OF_MEAN|10.57||0.6529|TWO_SIDED|90.0|-21.6|13.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||13.2|-21.6|0.6529
71907834|NCT00880763|143338100|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.9|||||TWO_SIDED|95.0|-12.4|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.4|
71907835|NCT00880763|143338100|SUPERIORITY_OR_OTHER||Adjusted difference in percent|4.8|||||TWO_SIDED|95.0|-12.0|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||24.2|-12.0|
71907836|NCT00880763|143338101|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.5|||||TWO_SIDED|95.0|-2.5|36.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.2|-2.5|
71907837|NCT00880763|143338101|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.6|||||TWO_SIDED|95.0|-3.4|36.3|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.3|-3.4|
71907838|NCT00880763|143338101|SUPERIORITY_OR_OTHER||Adjusted difference in percent|14.4|||||TWO_SIDED|95.0|-3.3|36.1|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)|||36.1|-3.3|
71907839|NCT00880763|143338102|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.8|||||TWO_SIDED|95.0|-2.3|-1.2|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.2|-2.3|
71907840|NCT00880763|143338102|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.9|||||TWO_SIDED|95.0|-2.4|-1.3|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.3|-2.4|
71907841|NCT00880763|143338102|SUPERIORITY_OR_OTHER||Difference in least squares mean|-1.6|||||TWO_SIDED|95.0|-2.2|-1.1|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.|||-1.1|-2.2|
71907842|NCT01293006|143338116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|||||TWO_SIDED|90.0|-0.12|0.91|||Difference of Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.91|-0.12|
71907843|NCT01293006|143338119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03|||||TWO_SIDED|90.0|-1.3|3.36|||Difference of the Least Means Squares|||Day 1, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||3.36|-1.30|
71907844|NCT01293006|143338119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|||||TWO_SIDED|90.0|-0.08|0.5|||Difference of the Least Squares Means|||Day 1, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.50|-0.08|
71907845|NCT01293006|143338119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|90.0|-5.77|7.41|||Difference of the Least Squares Means|||Day 4, SaO2 \<90%, Difference (Suvorexant - Placebo) of Least Squares Means||7.41|-5.77|
71907846|NCT01293006|143338119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|||||TWO_SIDED|90.0|0.0|0.63|||Difference of the Least Squares Means|||Day 4, SaO2 \<85%, Difference (Suvorexant - Placebo) of Least Squares Means||0.63|0.00|
71907847|NCT01293006|143338120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|||||TWO_SIDED|90.0|-0.6|2.04|||Difference of the Least Squares Means|||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means||2.04|-0.60|
71907848|NCT01293006|143338120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|||||TWO_SIDED|90.0|0.33|3.77|||Difference of the Least Squares Means|||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means||3.77|0.33|
71907849|NCT01293006|143338121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|||||TWO_SIDED|90.0|-0.41|0.47|||Difference in the Least Squares Means|||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.47|-0.41|
71907850|NCT01293006|143338121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|||||TWO_SIDED|90.0|-0.53|0.27|||Difference of the Least Squares Means|||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.27|-0.53|
71907851|NCT01293006|143338121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|||||TWO_SIDED|90.0|-0.61|0.18|||Difference of the Least Squares Means|||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.18|-0.61|
71907852|NCT01293006|143338121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|||||TWO_SIDED|90.0|-0.32|0.98|||Difference of the Least Squares Means|||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.98|-0.32|
71862050|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-12.8|STANDARD_ERROR_OF_MEAN|10.36||0.8878|TWO_SIDED|90.0|-29.8|4.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Pain at its Worst)||4.3|-29.8|0.8878
71862051|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-6.2|STANDARD_ERROR_OF_MEAN|10.11||0.7259|TWO_SIDED|90.0|-22.9|10.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||10.4|-22.9|0.7259
71862052|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|14.8|STANDARD_ERROR_OF_MEAN|10.24||0.0826|TWO_SIDED|90.0|-2.1|31.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||31.6|-2.1|0.0826
71862053|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-8.0|STANDARD_ERROR_OF_MEAN|9.75||0.7884|TWO_SIDED|90.0|-24.1|8.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Pain at its Worst)||8.0|-24.1|0.7884
71862054|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-16.1|STANDARD_ERROR_OF_MEAN|10.43||0.9326|TWO_SIDED|90.0|-33.2|1.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||1.1|-33.2|0.9326
71862055|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-4.9|STANDARD_ERROR_OF_MEAN|10.41||0.681|TWO_SIDED|90.0|-22.1|12.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||12.2|-22.1|0.6810
71862056|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.52||0.8308|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Pain at its Worst)||7.0|-27.6|0.8308
71862057|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|-8.5|STANDARD_ERROR_OF_MEAN|9.71||0.8063|TWO_SIDED|90.0|-24.5|7.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||7.4|-24.5|0.8063
71862058|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|10.27||0.2649|TWO_SIDED|90.0|-10.4|23.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||23.4|-10.4|0.2649
71862059|NCT04092452|143239561|SUPERIORITY||Risk Difference (RD)|5.3|STANDARD_ERROR_OF_MEAN|10.35||0.3029|TWO_SIDED|90.0|-11.7|22.4||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Pain at its Worst)||22.4|-11.7|0.3029
71862060|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|7.7|STANDARD_ERROR_OF_MEAN|8.2||0.1687|TWO_SIDED|90.0|-5.7|21.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||21.2|-5.7|0.1687
71862061|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|13.8|STANDARD_ERROR_OF_MEAN|8.03||0.0376|TWO_SIDED|90.0|0.6|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||27.0|0.6|0.0376
71862062|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-1.5|STANDARD_ERROR_OF_MEAN|6.9||0.5883|TWO_SIDED|90.0|-12.9|9.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 1 (Average Pain)||9.8|-12.9|0.5883
71862063|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|9.07||0.3829|TWO_SIDED|90.0|-12.2|17.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||17.6|-12.2|0.3829
71862064|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|18.2|STANDARD_ERROR_OF_MEAN|9.54||0.0316|TWO_SIDED|90.0|2.5|33.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||33.9|2.5|0.0316
71862065|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|4.6|STANDARD_ERROR_OF_MEAN|9.17||0.3072|TWO_SIDED|90.0|-10.5|19.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 2 (Average Pain)||19.7|-10.5|0.3072
71862066|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-13.1|STANDARD_ERROR_OF_MEAN|10.18||0.8952|TWO_SIDED|90.0|-29.8|3.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||3.7|-29.8|0.8952
71862067|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|10.76||0.1157|TWO_SIDED|90.0|-4.6|30.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||30.8|-4.6|0.1157
71862068|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|10.93||0.4672|TWO_SIDED|90.0|-17.1|18.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 4 (Average Pain)||18.9|-17.1|0.4672
71681598|NCT02987972|142881461|OTHER||GMC Ratio|0.72|||||TWO_SIDED|95.0|0.62|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.82|0.62|
71862069|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-16.9|STANDARD_ERROR_OF_MEAN|11.29||0.9287|TWO_SIDED|90.0|-35.5|1.6||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||1.6|-35.5|0.9287
71862070|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|10.85||0.4984|TWO_SIDED|90.0|-17.8|17.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||17.9|-17.8|0.4984
71862071|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-14.7|STANDARD_ERROR_OF_MEAN|11.27||0.9001|TWO_SIDED|90.0|-33.2|3.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 6 (Average Pain)||3.9|-33.2|0.9001
71862072|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-10.3|STANDARD_ERROR_OF_MEAN|10.53||0.8319|TWO_SIDED|90.0|-27.6|7.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||7.0|-27.6|0.8319
71862073|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|19.7|STANDARD_ERROR_OF_MEAN|10.55||0.034|TWO_SIDED|90.0|2.3|37.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||37.0|2.3|0.0340
71862074|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-6.8|STANDARD_ERROR_OF_MEAN|10.7||0.7359|TWO_SIDED|90.0|-24.4|10.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8 (Average Pain)||10.8|-24.4|0.7359
71862075|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-16.0|STANDARD_ERROR_OF_MEAN|10.51||0.9291|TWO_SIDED|90.0|-33.3|1.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||1.3|-33.3|0.9291
71862076|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|10.44||0.5087|TWO_SIDED|90.0|-17.4|16.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||16.9|-17.4|0.5087
71862077|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-9.5|STANDARD_ERROR_OF_MEAN|10.74||0.8098|TWO_SIDED|90.0|-27.2|8.1||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12 (Average Pain)||8.1|-27.2|0.8098
71907853|NCT01293006|143338121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|90.0|-0.26|0.78|||Difference of the Least Squares Means|||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means||0.78|-0.26|
71907854|NCT01293006|143338121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|||||TWO_SIDED|90.0|0.1|0.8|||Difference of the Least Squares Means|||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means||0.80|0.10|
71907855|NCT01293006|143338122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.5|0.31|||Difference in the Least Squares Means|||Difference (Suvorexant - Placebo) of Least Squares Means||0.31|-0.50|
71862078|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|-8.8|STANDARD_ERROR_OF_MEAN|9.76||0.8114|TWO_SIDED|90.0|-24.8|7.2||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||7.2|-24.8|0.8114
71862079|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|10.8|STANDARD_ERROR_OF_MEAN|10.44||0.1531|TWO_SIDED|90.0|-6.4|28.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||28.0|-6.4|0.1531
71862080|NCT04092452|143239562|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|10.58||0.3784|TWO_SIDED|90.0|-14.1|20.7||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16 (Average Pain)||20.7|-14.1|0.3784
71862081|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-7.44|STANDARD_ERROR_OF_MEAN|6.661||0.1321|TWO_SIDED|90.0|-18.39|3.52||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||3.52|-18.39|0.1321
71862082|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-10.52|STANDARD_ERROR_OF_MEAN|6.308||0.0477|TWO_SIDED|90.0|-20.9|-0.14||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-0.14|-20.90|0.0477
71862083|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-14.13|STANDARD_ERROR_OF_MEAN|6.379||0.0134|TWO_SIDED|90.0|-24.62|-3.63||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||-3.63|-24.62|0.0134
71862084|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-5.66|STANDARD_ERROR_OF_MEAN|8.38||0.2496|TWO_SIDED|90.0|-19.45|8.12||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||8.12|-19.45|0.2496
71862085|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-11.92|STANDARD_ERROR_OF_MEAN|7.972||0.0675|TWO_SIDED|90.0|-25.03|1.2||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.20|-25.03|0.0675
71862086|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-11.71|STANDARD_ERROR_OF_MEAN|8.054||0.073|TWO_SIDED|90.0|-24.96|1.54||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||1.54|-24.96|0.0730
71862087|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|3.25|STANDARD_ERROR_OF_MEAN|8.892||0.6426|TWO_SIDED|90.0|-11.38|17.88||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||17.88|-11.38|0.6426
71862088|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-7.82|STANDARD_ERROR_OF_MEAN|8.457||0.1776|TWO_SIDED|90.0|-21.73|6.09||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||6.09|-21.73|0.1776
71862089|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-1.17|STANDARD_ERROR_OF_MEAN|8.579||0.4458|TWO_SIDED|90.0|-15.28|12.94||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||12.94|-15.28|0.4458
71862090|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|7.94|STANDARD_ERROR_OF_MEAN|9.566||0.7969|TWO_SIDED|90.0|-7.79|23.68||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||23.68|-7.79|0.7969
71907856|NCT01494987|143338123|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.71|-0.32||P-value is from a mixed-effect model including terms for baseline HbA1c value, prior antihyperglycemia therapy, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.||-0.32|-0.71|<0.001
71862091|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-11.09|STANDARD_ERROR_OF_MEAN|9.12||0.112|TWO_SIDED|90.0|-26.09|3.91||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||3.91|-26.09|0.1120
71907857|NCT02215616|143338145|OTHER||Least square (LS) mean difference|0.78||||0.4853|TWO_SIDED|95.0|-1.42|2.98||Threshold for significance at 0.045 level.|Mixed Models Analysis|||Analysis was performed using Mixed Model Repeated Measures model (MMRM) with treatment group (3 levels: placebo, laquinimod 0.5 mg and laquinimod 1 mg), categorical week (4 levels: Weeks 4, 13, 26, and 52), treatment by week interaction, country, TMS baseline value and TMS baseline by week interaction as fixed effects. Unstructured variance-covariance structure was used in the initial model.||2.98|-1.42|0.4853
71862092|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|9.188||0.5021|TWO_SIDED|90.0|-15.06|15.16||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||15.16|-15.06|0.5021
71862093|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|2.83|STANDARD_ERROR_OF_MEAN|9.296||0.6197|TWO_SIDED|90.0|-12.46|18.12||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||18.12|-12.46|0.6197
71862094|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-11.3|STANDARD_ERROR_OF_MEAN|8.825||0.1003|TWO_SIDED|90.0|-25.81|3.22||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||3.22|-25.81|0.1003
71907858|NCT03532776|143338219|EQUIVALENCE|BE limits: -20.0% to 20.0%|Equivalence ratio|0.98|||||TWO_SIDED|90.0|-12.0|7.0||||||||7|-12|
71681599|NCT02987972|142881461|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.22|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||1.22|0.93|
71862095|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|8.908||0.507|TWO_SIDED|90.0|-14.5|14.81||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||14.81|-14.50|0.5070
71862096|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|0.67|STANDARD_ERROR_OF_MEAN|9.368||0.5283|TWO_SIDED|90.0|-14.74|16.08||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||16.08|-14.74|0.5283
71862097|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-15.31|STANDARD_ERROR_OF_MEAN|8.921||0.0431|TWO_SIDED|90.0|-29.98|-0.63||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||-0.63|-29.98|0.0431
71862098|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-6.39|STANDARD_ERROR_OF_MEAN|9.02||0.2395|TWO_SIDED|90.0|-21.22|8.45||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||8.45|-21.22|0.2395
71862099|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|2.57|STANDARD_ERROR_OF_MEAN|9.617||0.6054|TWO_SIDED|90.0|-13.25|18.39||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||18.39|-13.25|0.6054
71862100|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-21.54|STANDARD_ERROR_OF_MEAN|9.344||0.0106|TWO_SIDED|90.0|-36.91|-6.17||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-6.17|-36.91|0.0106
71862101|NCT04092452|143239563|SUPERIORITY||Risk Difference (RD)|-12.54|STANDARD_ERROR_OF_MEAN|9.305||0.089|TWO_SIDED|90.0|-27.84|2.77||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||2.77|-27.84|0.0890
71862102|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-6.17|STANDARD_ERROR_OF_MEAN|5.963||0.1505|TWO_SIDED|90.0|-15.98|3.64||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.64|-15.98|0.1505
71862103|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-11.06|STANDARD_ERROR_OF_MEAN|5.555||0.0233|TWO_SIDED|90.0|-20.19|-1.92||One-sided p-value|ANCOVA|||Week 1 Average Pain||-1.92|-20.19|0.0233
71862104|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-6.34|STANDARD_ERROR_OF_MEAN|5.926||0.1423|TWO_SIDED|90.0|-16.09|3.41||One-sided p-value|ANCOVA|||Week 1 Average Pain||3.41|-16.09|0.1423
71862105|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-2.15|STANDARD_ERROR_OF_MEAN|7.202||0.3827|TWO_SIDED|90.0|-14.0|9.7||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.70|-14.00|0.3827
71862106|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-10.35|STANDARD_ERROR_OF_MEAN|6.741||0.0624|TWO_SIDED|90.0|-21.44|0.74||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.74|-21.44|0.0624
71907859|NCT02513771|143338250|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank-sum test stratified by screening CD4 count (\<= or \> 350 cells/mm\^3) and statin use.||Null hypothesis: There is no difference between the two arms in the change in sCD14 from baseline to week 15/16.||||1.000
71681600|NCT02987972|142881461|OTHER||GMC Ratio|0.67|||||TWO_SIDED|95.0|0.59|0.77|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.77|0.59|
71681601|NCT02987972|142881461|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.79|0.60|
71862107|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-2.25|STANDARD_ERROR_OF_MEAN|7.171||0.3771|TWO_SIDED|90.0|-14.04|9.55||One-sided p-value|ANCOVA|||Week 2 Average Pain||9.55|-14.04|0.3771
71862108|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|8.04|STANDARD_ERROR_OF_MEAN|8.614||0.8247|TWO_SIDED|90.0|-6.13|22.21||One-sided p-value|ANCOVA|||Week 4 Average Pain||22.21|-6.13|0.8247
71862109|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-8.97|STANDARD_ERROR_OF_MEAN|8.09||0.1337|TWO_SIDED|90.0|-22.28|4.33||One-sided p-value|ANCOVA|||Week 4 Average Pain||4.33|-22.28|0.1337
71862110|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|5.37|STANDARD_ERROR_OF_MEAN|8.523||0.7357|TWO_SIDED|90.0|-8.65|19.39||One-sided p-value|ANCOVA|||Week 4 Average Pain||19.39|-8.65|0.7357
71862111|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|13.78|STANDARD_ERROR_OF_MEAN|8.977||0.9377|TWO_SIDED|90.0|-0.98|28.55||One-sided p-value|ANCOVA|||Week 6 Average Pain||28.55|-0.98|0.9377
71862112|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-9.39|STANDARD_ERROR_OF_MEAN|8.45||0.1332|TWO_SIDED|90.0|-23.29|4.51||One-sided p-value|ANCOVA|||Week 6 Average Pain||4.51|-23.29|0.1332
71862113|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|6.05|STANDARD_ERROR_OF_MEAN|8.907||0.7514|TWO_SIDED|90.0|-8.6|20.7||One-sided p-value|ANCOVA|||Week 6 Average Pain||20.70|-8.60|0.7514
71907860|NCT01595438|143338266|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
71862114|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|8.97|STANDARD_ERROR_OF_MEAN|8.902||0.8433|TWO_SIDED|90.0|-5.67|23.62||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.62|-5.67|0.8433
71862115|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-8.84|STANDARD_ERROR_OF_MEAN|8.392||0.1461|TWO_SIDED|90.0|-22.64|4.96||One-sided p-value|ANCOVA|||Week 8 Average Pain||4.96|-22.64|0.1461
71862116|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|8.64|STANDARD_ERROR_OF_MEAN|8.818||0.8364|TWO_SIDED|90.0|-5.86|23.15||One-sided p-value|ANCOVA|||Week 8 Average Pain||23.15|-5.86|0.8364
71862117|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|2.35|STANDARD_ERROR_OF_MEAN|8.527||0.6085|TWO_SIDED|90.0|-11.68|16.37||One-sided p-value|ANCOVA|||Week 12 Average Pain||16.37|-11.68|0.6085
71862118|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-14.38|STANDARD_ERROR_OF_MEAN|8.022||0.0365|TWO_SIDED|90.0|-27.58|-1.19||One-sided p-value|ANCOVA|||Week 12 Average Pain||-1.19|-27.58|0.0365
71862119|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|8.469||0.5201|TWO_SIDED|90.0|-13.5|14.36||One-sided p-value|ANCOVA|||Week 12 Average Pain||14.36|-13.50|0.5201
71681602|NCT02987972|142881461|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||1.02|0.76|
71862120|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|4.04|STANDARD_ERROR_OF_MEAN|8.564||0.6813|TWO_SIDED|90.0|-10.05|18.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||18.12|-10.05|0.6813
71862121|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-18.38|STANDARD_ERROR_OF_MEAN|8.23||0.0128|TWO_SIDED|90.0|-31.91|-4.84||One-sided p-value|ANCOVA|||Week 16 Average Pain||-4.84|-31.91|0.0128
71862122|NCT04092452|143239564|SUPERIORITY||Risk Difference (RD)|-4.09|STANDARD_ERROR_OF_MEAN|8.639||0.3181|TWO_SIDED|90.0|-18.3|10.12||One-sided p-value|ANCOVA|||Week 16 Average Pain||10.12|-18.30|0.3181
71862123|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.301||0.1536|TWO_SIDED|90.0|-0.8|0.19||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.19|-0.80|0.1536
71862124|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.289||0.0581|TWO_SIDED|90.0|-0.93|0.02||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.02|-0.93|0.0581
71862125|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.3||0.0532|TWO_SIDED|90.0|-0.98|0.01||One-sided p-value|ANCOVA|||Week 1 Pain at its Worst||0.01|-0.98|0.0532
71862126|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.383||0.2007|TWO_SIDED|90.0|-0.95|0.31||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.31|-0.95|0.2007
71862127|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.55|STANDARD_ERROR_OF_MEAN|0.37||0.0694|TWO_SIDED|90.0|-1.16|0.06||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.06|-1.16|0.0694
71862128|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.382||0.1509|TWO_SIDED|90.0|-1.02|0.23||One-sided p-value|ANCOVA|||Week 2 Pain at its Worst||0.23|-1.02|0.1509
71681603|NCT02987972|142881461|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.81|1.08|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.08|0.81|
71862129|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.431||0.5663|TWO_SIDED|90.0|-0.64|0.78||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.78|-0.64|0.5663
71862130|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.416||0.1396|TWO_SIDED|90.0|-1.13|0.23||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.23|-1.13|0.1396
71862131|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.432||0.5227|TWO_SIDED|90.0|-0.69|0.74||One-sided p-value|ANCOVA|||Week 4 Pain at its Worst||0.74|-0.69|0.5227
71862132|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.45||0.8656|TWO_SIDED|90.0|-0.24|1.24||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||1.24|-0.24|0.8656
71862133|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.434||0.1671|TWO_SIDED|90.0|-1.13|0.29||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.29|-1.13|0.1671
71862134|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.45||0.6063|TWO_SIDED|90.0|-0.62|0.86||One-sided p-value|ANCOVA|||Week 6 Pain at its Worst||0.86|-0.62|0.6063
71862135|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.458||0.6402|TWO_SIDED|90.0|-0.59|0.92||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.92|-0.59|0.6402
71862136|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.38|STANDARD_ERROR_OF_MEAN|0.441||0.1916|TWO_SIDED|90.0|-1.11|0.34||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.34|-1.11|0.1916
71862137|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.13|STANDARD_ERROR_OF_MEAN|0.456||0.6119|TWO_SIDED|90.0|-0.62|0.88||One-sided p-value|ANCOVA|||Week 8 Pain at its Worst||0.88|-0.62|0.6119
71862138|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.45||0.5568|TWO_SIDED|90.0|-0.68|0.8||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.80|-0.68|0.5568
71862139|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.433||0.0976|TWO_SIDED|90.0|-1.27|0.15||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.15|-1.27|0.0976
71862140|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.451||0.5001|TWO_SIDED|90.0|-0.74|0.74||One-sided p-value|ANCOVA|||Week 12 Pain at its Worst||0.74|-0.74|0.5001
71681604|NCT02987972|142881461|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.78|1.01|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||1.01|0.78|
71862141|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.451||0.581|TWO_SIDED|90.0|-0.65|0.83||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.83|-0.65|0.5810
71862142|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-1.07|STANDARD_ERROR_OF_MEAN|0.442||0.0079|TWO_SIDED|90.0|-1.8|-0.34||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||-0.34|-1.80|0.0079
71862143|NCT04092452|143239565|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.455||0.1068|TWO_SIDED|90.0|-1.31|0.18||One-sided p-value|ANCOVA|||Week 16 Pain at its Worst||0.18|-1.31|0.1068
71862144|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.284||0.1898|TWO_SIDED|90.0|-0.72|0.22||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.22|-0.72|0.1898
71862145|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.273||0.0562|TWO_SIDED|90.0|-0.88|0.02||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.02|-0.88|0.0562
71681605|NCT02987972|142881461|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.10|0.85|
71681606|NCT02987972|142881461|OTHER||GMC Ratio|0.75|||||TWO_SIDED|95.0|0.64|0.87|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||0.87|0.64|
71862146|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.284||0.1382|TWO_SIDED|90.0|-0.78|0.16||One-sided p-value|ANCOVA|||Week 1 Average Pain||0.16|-0.78|0.1382
71681607|NCT02987972|142881461|OTHER||GMC Ratio|149.69|||||TWO_SIDED|95.0|130.23|172.06|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||172.06|130.23|
71862147|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.343||0.2039|TWO_SIDED|90.0|-0.85|0.28||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.28|-0.85|0.2039
71862148|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.45|STANDARD_ERROR_OF_MEAN|0.332||0.0855|TWO_SIDED|90.0|-1.0|0.09||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.09|-1.00|0.0855
71907861|NCT01595438|143338267|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
71907862|NCT01595438|143338268|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
71907863|NCT01595438|143338269|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
71907864|NCT01595438|143338270|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
71907865|NCT01595438|143338271|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
71907866|NCT01595438|143338272|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
71907867|NCT01595438|143338273|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
71907868|NCT01595438|143338274|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
71907869|NCT01595438|143338275|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
71907870|NCT01595438|143338276|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
71907871|NCT01595438|143338277|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
71907872|NCT01595438|143338278|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
71907873|NCT01595438|143338279|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
71907874|NCT01595438|143338280|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
71907875|NCT01595438|143338281|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
71907876|NCT01595438|143338282|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
71907877|NCT01595438|143338283|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
71907878|NCT01595438|143338284|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
71907879|NCT01595438|143338285|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
71907880|NCT01595438|143338286|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
71907881|NCT01595438|143338287|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
71907882|NCT01595438|143338288|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
71907883|NCT01595438|143338289|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
71907884|NCT01595438|143338290|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
71907885|NCT01595438|143338291|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
71907886|NCT01595438|143338292|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
71907887|NCT01595438|143338293|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
71907888|NCT01595438|143338294|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
71907889|NCT01595438|143338295|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
71907890|NCT01595438|143338296|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
71907891|NCT01595438|143338297|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
71688737|NCT03749109|142892877|OTHER||Difference in LS mean|2.25||||0.93|TWO_SIDED|95.0|-49.57|54.06|||ANCOVA|ANCOVA adjusted for baseline lesion size.||Adenomyosis at cycle 4||54.06|-49.57|0.93
71907892|NCT01595438|143338298|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
71907893|NCT03373110|143338334|OTHER|||||||0.973||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models fit via maximum likelihood to examine the effect of the interventions on daily steps. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction. We used separate models to assess the intervention effects across the 8-week intervention period as well as the complete 16-week follow-up period.|The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.973
71907894|NCT03373110|143338334|OTHER|||||||0.005||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.005
71907895|NCT03373110|143338334|OTHER|||||||0.004||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 8 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||.004
71907896|NCT03373110|143338334|OTHER|||||||0.627||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.627
71907897|NCT03373110|143338334|OTHER|||||||0.359||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.359
71922078|NCT03091920|143364993|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.67|||TWO_SIDED|95.0|-9.93|5.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||5.35|-9.93|
71681608|NCT02987972|142881461|OTHER||GMC Ratio|90.35|||||TWO_SIDED|95.0|79.93|102.12|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||102.12|79.93|
71681609|NCT02987972|142881461|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.71|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1||0.93|0.71|
71907898|NCT03373110|143338334|OTHER|||||||0.597||||||A two-sided significance level of 0.05 was used for all analyses.|Mixed Models Analysis|||We used linear mixed effects models to examine the effect of the interventions on average daily steps at 16 weeks into the study. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to adjust for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|We used linear mixed effects models to examine the effect of the interventions on daily steps. These models account for the covariance of repeated measurements within subjects, and we used maximum likelihood estimation to account for missing daily step counts. The models include a random intercept and fixed effects for intervention, time, and an intervention by time interaction.|||0.597
71907899|NCT01804036|143338356|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|||||||0.84
71907900|NCT01804036|143338357|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANCOVA|||||||0.11
71907901|NCT01804036|143338358|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
71907902|NCT01804036|143338359|SUPERIORITY_OR_OTHER|||||||0.08|||||||ANCOVA|||||||0.08
71907903|NCT01804036|143338360|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANCOVA|||||||0.20
71907904|NCT01804036|143338361|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
71907905|NCT01804036|143338362|SUPERIORITY_OR_OTHER|||||||0.52|||||||ANCOVA|||||||0.52
71681610|NCT02987972|142881461|OTHER||GMC Ratio|1.48|||||TWO_SIDED|95.0|1.31|1.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3||1.68|1.31|
71907906|NCT01804036|143338363|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
71907907|NCT01804036|143338364|SUPERIORITY_OR_OTHER|||||||0.94|||||||ANCOVA|||||||0.94
71681611|NCT02987972|142881461|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.7|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4||0.94|0.70|
71681612|NCT02987972|142881461|OTHER||GMC Ratio|0.69|||||TWO_SIDED|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5||0.79|0.60|
71907908|NCT01804036|143338365|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
71907909|NCT01804036|143338366|SUPERIORITY_OR_OTHER|||||||0.49|||||||ANCOVA|||||||0.49
71907910|NCT01804036|143338367|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71907911|NCT01804036|143338368|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71907912|NCT01804036|143338369|SUPERIORITY_OR_OTHER|||||||0.13|||||||ANCOVA|||||||0.13
71907913|NCT03483116|143338371|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%.|Response rate|0.1553|||||TWO_SIDED|95.0|0.039|0.272||||||||0.272|0.039|
71907914|NCT03483116|143338371|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Response rate|0.001|||||TWO_SIDED|95.0|-0.115|0.117||||||||0.117|-0.115|
71907915|NCT03483116|143338371|NON_INFERIORITY|Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%|Difference Response rate|0.1543|||||TWO_SIDED|95.0|0.038|0.27||||||Non-inferiority of the lower titre vaccine was demonstrated if the upper bound of the CI was below 20%||0.270|0.038|
71907916|NCT01181102|143338381|NON_INFERIORITY_OR_EQUIVALENCE|"(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.~(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)"|Cox Proportional Hazard|-6.5|||<|0.001|TWO_SIDED|95.0|-11.5|-1.6||non-inferiority:P \< 0.001 superiority:P = 0.010|non-inferiority:Z test. superiority:χ2 t|||The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).||-1.6|-11.5|<0.001
71907917|NCT01181102|143338382|SUPERIORITY_OR_OTHER||χ2 test|2.5|||||TWO_SIDED|95.0|-0.8|5.9||||||||5.9|-0.8|
71907918|NCT01315002|143338384|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.||||<0.05
71907919|NCT05053126|143338385|SUPERIORITY||Mean Difference (Final Values)|36.83|STANDARD_ERROR_OF_MEAN|3.132|<|0.0001|ONE_SIDED|95.0|31.65||||Mixed Models Analysis|||"The sensitivity and integrity of the study was validated by comparing the mean responses of oxycodone HCl, the positive control (C), to the placebo (P):~H0: μC - μP ≤ δ1 versus Ha: μC - μP \> δ1 where δ1 =15"|||31.65|<0.0001
71907920|NCT05053126|143338385|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|3.49||0.2469|ONE_SIDED|95.0||3.4|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||3.4||0.2469
71681613|NCT02987972|142881461|OTHER||GMC Ratio|0.66|||||TWO_SIDED|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A||0.76|0.58|
71907921|NCT05053126|143338385|NON_INFERIORITY|Non-inferiority margin = 0|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|3.48||0.1756|ONE_SIDED|95.0||2.5|||Mixed Models Analysis|||"The primary analysis evaluated whether pregabalin plus oxycodone HCl (T) produced mean responses that showed abuse potential that was no higher than oxycodone HCl (C). The margin for showing no significant difference was defined as 20% of the difference between oxycodone HCl (C) and Placebo (P):~H0: μT - μC ≥ 0.2(μC - μP) versus Ha: μT - μC \<0.2(μC - μP)."||2.5||0.1756
71907922|NCT05053126|143338385|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.84||0.0001|ONE_SIDED|95.0||4.3|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||4.3||0.0001
71907923|NCT05053126|143338385|NON_INFERIORITY|Non-inferiority margin = 10|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|2.84||0.0099|ONE_SIDED|95.0||8.0|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show less abuse potential than oxycodone HCl (C) were:~H0: μC - μL ≤ 0.2 (μC - 50) versus Ha: μC - μL \> 0.2 (μC - 50)"||8.0||0.0099
71907924|NCT05053126|143338385|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|18.2|STANDARD_ERROR_OF_MEAN|3.13||0.9888|ONE_SIDED|95.0||23.4|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||23.4||0.9888
71907925|NCT05053126|143338385|NON_INFERIORITY|Non-inferiority margin = 11|Mean Difference (Final Values)|22.0|STANDARD_ERROR_OF_MEAN|3.13||0.9997|ONE_SIDED|95.0||27.1|||Mixed Models Analysis|||"The null and alternative hypotheses for evaluating whether pregabalin (L) produced mean responses that show abuse potential similar to placebo(P) were:~H0: μL - μp ≥ δ2 versus Ha: μL - μp \< δ2 where δ2 = 11"||27.1||0.9997
71907926|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|75.6|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|65.79|85.42|||Mixed Models Analysis|||||85.42|65.79|<0.0001
71907927|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|44.84|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|35.03|54.65|||Mixed Models Analysis|||||54.65|35.03|<0.0001
71907928|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|49.93|STANDARD_ERROR_OF_MEAN|5.945|<|0.0001|TWO_SIDED|90.0|40.12|59.75|||Mixed Models Analysis|||||59.75|40.12|<0.0001
71907929|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|80.8|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|70.99|90.61|||Mixed Models Analysis|||||90.61|70.99|<0.0001
71907930|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|81.91|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|72.09|91.73|||Mixed Models Analysis|||||91.73|72.09|<0.0001
71681614|NCT02987972|142881461|OTHER||GMC Ratio|0.83|||||TWO_SIDED|95.0|0.72|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B||0.95|0.72|
71907931|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|-30.8|STANDARD_ERROR_OF_MEAN|5.948|<|0.0001|TWO_SIDED|90.0|-40.6|-20.9|||Mixed Models Analysis|||||-20.9|-40.6|<0.0001
71907932|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|-25.7|STANDARD_ERROR_OF_MEAN|5.942|<|0.0001|TWO_SIDED|90.0|-35.5|-15.9|||Mixed Models Analysis|||||-15.9|-35.5|<0.0001
71907933|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.945||0.3829|TWO_SIDED|90.0|-4.62|15.01|||Mixed Models Analysis|||||15.01|-4.62|0.3829
71907934|NCT05053126|143338386|OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|5.942||0.2896|TWO_SIDED|90.0|-3.5|16.11|||Mixed Models Analysis|||||16.11|-3.50|0.2896
71907935|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|23.47|STANDARD_ERROR_OF_MEAN|2.247|<|0.0001|TWO_SIDED|90.0|19.77|27.17|||Mixed Models Analysis|||||27.17|19.77|<0.0001
71907936|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|10.4|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|6.71|14.09|||Mixed Models Analysis|||||14.09|6.71|<0.0001
71907937|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|11.29|STANDARD_ERROR_OF_MEAN|2.248|<|0.0001|TWO_SIDED|90.0|7.59|14.99|||Mixed Models Analysis|||||14.99|7.59|<0.0001
71907938|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|24.33|STANDARD_ERROR_OF_MEAN|2.251|<|0.0001|TWO_SIDED|90.0|20.62|28.03|||Mixed Models Analysis|||||28.03|20.62|<0.0001
71907939|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|22.34|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|18.65|26.04|||Mixed Models Analysis|||||26.04|18.65|<0.0001
71907940|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.245|<|0.0001|TWO_SIDED|90.0|-16.8|-9.38|||Mixed Models Analysis|||||-9.38|-16.8|<0.0001
71907941|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.252|<|0.0001|TWO_SIDED|90.0|-15.9|-8.47|||Mixed Models Analysis|||||-8.47|-15.9|<0.0001
71907942|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|2.258||0.7051|TWO_SIDED|90.0|-2.86|4.57|||Mixed Models Analysis|||||4.57|-2.86|0.7051
71907943|NCT05053126|143338387|OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|2.246||0.616|TWO_SIDED|90.0|-4.82|2.57|||Mixed Models Analysis|||||2.57|-4.82|0.6160
71907944|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|21.99|STANDARD_ERROR_OF_MEAN|2.235|<|0.0001|TWO_SIDED|90.0|18.31|25.67|||Mixed Models Analysis|||||25.67|18.31|<0.0001
71907945|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|6.4|STANDARD_ERROR_OF_MEAN|2.227||0.0042|TWO_SIDED|90.0|2.73|10.07|||Mixed Models Analysis|||||10.07|2.73|0.0042
71907946|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|2.236|<|0.0001|TWO_SIDED|90.0|6.12|13.48|||Mixed Models Analysis|||||13.48|6.12|<0.0001
71907947|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|21.12|STANDARD_ERROR_OF_MEAN|2.239|<|0.0001|TWO_SIDED|90.0|17.44|24.81|||Mixed Models Analysis|||||24.81|17.44|<0.0001
71907948|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|21.27|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|17.59|24.95|||Mixed Models Analysis|||||24.95|17.59|<0.0001
71907949|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|2.233|<|0.0001|TWO_SIDED|90.0|-19.3|-11.9|||Mixed Models Analysis|||||-11.9|-19.3|<0.0001
71907950|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|2.24|<|0.0001|TWO_SIDED|90.0|-15.9|-8.5|||Mixed Models Analysis|||||-8.50|-15.9|<0.0001
71681615|NCT02987972|142881461|OTHER||GMC Ratio|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F||0.81|0.62|
71907951|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|2.246||0.7001|TWO_SIDED|90.0|-4.56|2.83|||Mixed Models Analysis|||||2.83|-4.56|0.7001
71907952|NCT05053126|143338388|OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|2.233||0.7479|TWO_SIDED|90.0|-4.4|2.96|||Mixed Models Analysis|||||2.96|-4.40|0.7479
71907953|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|27.82|STANDARD_ERROR_OF_MEAN|1.439|<|0.0001|TWO_SIDED|90.0|25.45|30.19|||Mixed Models Analysis|||||30.19|25.45|<0.0001
71907954|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|14.53|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|12.17|16.89|||Mixed Models Analysis|||||16.89|12.17|<0.0001
71907955|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|17.85|STANDARD_ERROR_OF_MEAN|1.437|<|0.0001|TWO_SIDED|90.0|15.49|20.22|||Mixed Models Analysis|||||20.22|15.49|<0.0001
71907956|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|34.4|STANDARD_ERROR_OF_MEAN|1.438|<|0.0001|TWO_SIDED|90.0|34.4|36.77|||Mixed Models Analysis|||||36.77|34.40|<0.0001
71907957|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|38.84|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|90.0|36.47|41.21|||Mixed Models Analysis|||||41.21|36.47|<0.0001
71907958|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|-13.3|STANDARD_ERROR_OF_MEAN|1.434|<|0.0001|TWO_SIDED|90.0|-15.6|-10.9|||Mixed Models Analysis|||||-10.9|-15.6|<0.0001
71907959|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|-9.97|STANDARD_ERROR_OF_MEAN|1.435|<|0.0001|TWO_SIDED|90.0|-12.3|-7.61|||Mixed Models Analysis|||||-7.61|-12.3|<0.0001
71907960|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|6.58|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|4.22|8.94|||Mixed Models Analysis|||||8.94|4.22|<0.0001
71907961|NCT05053126|143338389|OTHER||Mean Difference (Final Values)|11.02|STANDARD_ERROR_OF_MEAN|1.436|<|0.0001|TWO_SIDED|90.0|8.65|13.38|||Mixed Models Analysis|||||13.38|8.65|<0.0001
71907962|NCT05127421|143338424|SUPERIORITY||Odds Ratio (OR)|2.81||||0.091|TWO_SIDED|95.0|0.83|9.47|||Cochran-Mantel-Haenszel|stratified by the stratification factor (face and/or neck Investigator's Global Assessment \[IGA\] score of 2 or 3 at screening).||||9.47|0.83|0.091
71681616|NCT02987972|142881461|OTHER||GMC Ratio|0.77|||||TWO_SIDED|95.0|0.67|0.88|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V||0.88|0.67|
71907963|NCT05127421|143338424|SUPERIORITY||response rate difference|19.5|STANDARD_ERROR_OF_MEAN|10.23|||TWO_SIDED|95.0|-0.5|39.6|||||The 95% confidence interval was computed based on a large-sample normal approximation with continuity correction.|||39.6|-0.5|
71907964|NCT03488914|143338431|SUPERIORITY||Slope|-1.09||||0.19|TWO_SIDED|95.0|-2.78|0.56|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 3-months||||.56|-2.78|.19
71907965|NCT03488914|143338431|SUPERIORITY||negative binomial regression|-1.66||||0.12|TWO_SIDED|95.0|-3.78|0.48|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 6-months||||.48|-3.78|.12
71907966|NCT03488914|143338431|SUPERIORITY||Slope|0.01||||0.99|TWO_SIDED|95.0|-2.05|2.07|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 9-months||||2.07|-2.05|.99
71907967|NCT03488914|143338431|SUPERIORITY||Slope|-0.78||||0.42|TWO_SIDED|95.0|-2.67|1.11|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 12-months||||1.11|-2.67|.42
71907968|NCT03488914|143338431|SUPERIORITY||Slope|-1.09||||0.18|TWO_SIDED|95.0|-2.69|0.51|||negative binomial regression|Model testing whether condition predicted illicit drug use days at 15-months||||.51|-2.69|.18
71907969|NCT03488914|143338432|SUPERIORITY||Slope|0.03||||0.96|TWO_SIDED|95.0|-0.86|0.99|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 3-months||||.99|-.86|.96
71907970|NCT03488914|143338432|SUPERIORITY||Slope|-1.19||||0.03|TWO_SIDED|95.0|-2.25|-0.14|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 6-months||||-.14|-2.25|.03
71907971|NCT03488914|143338432|SUPERIORITY||Slope|0.13||||0.79|TWO_SIDED|95.0|-0.83|1.1|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 9-months||||1.10|-.83|.79
71907972|NCT03488914|143338432|SUPERIORITY||Slope|0.06||||0.91|TWO_SIDED|95.0|-0.99|1.11|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 12-months||||1.11|-.99|.91
71907973|NCT03488914|143338432|SUPERIORITY||Slope|-0.42||||0.44|TWO_SIDED|95.0|-1.5|0.65|||negative binomial regression|Model testing whether condition predicted condomless anal sex acts at 15-months||||.65|-1.50|.44
71907974|NCT03488914|143338433|SUPERIORITY||Slope|-0.26||||0.54|TWO_SIDED|95.0|-1.09|0.58|||negative binomial regression|Model testing whether condition predicted marijuana use days at 3-months||||.58|-1.09|.54
71907975|NCT03488914|143338433|SUPERIORITY||Slope|0.38||||0.49|TWO_SIDED|95.0|-0.7|1.46|||negative binomial regression|Model testing whether condition predicted marijuana use days at 6-months||||1.46|-.70|.49
71907976|NCT03488914|143338433|SUPERIORITY||Slope|-0.26||||0.59|TWO_SIDED|95.0|-1.18|0.66|||negative binomial regression|Model testing whether condition predicted marijuana use days at 9-months||||.66|-1.18|.59
71907977|NCT03488914|143338433|SUPERIORITY||Slope|0.26||||0.65|TWO_SIDED|95.0|-0.86|1.37|||negative binomial regression|Model testing whether condition predicted marijuana use days at 12-months||||1.37|-.86|.65
71907978|NCT03488914|143338433|SUPERIORITY||Slope|-0.36||||0.49|TWO_SIDED|95.0|-1.4|0.67|||negative binomial regression|Model testing whether condition predicted marijuana use days at 15-months||||.67|-1.40|.49
71907979|NCT03488914|143338434|SUPERIORITY||Slope|-0.36||||0.31|TWO_SIDED|995.0|-1.07|0.34|||negative binomial regression|Model testing whether condition predicted alcohol use days at 3-months||||.34|-1.07|.31
71907980|NCT03488914|143338434|SUPERIORITY||Slope|-0.71||||0.1|TWO_SIDED|95.0|-1.57|0.15|||negative binomial regression|Model testing whether condition predicted alcohol use days at 6-months||||.15|-1.57|.10
71907981|NCT03488914|143338434|SUPERIORITY||Slope|-0.53||||0.2|TWO_SIDED|95.0|-1.34|0.28|||negative binomial regression|Model testing whether condition predicted alcohol use days at 9-months||||.28|-1.34|.20
71907982|NCT03488914|143338434|SUPERIORITY||Slope|-0.25||||0.58|TWO_SIDED|95.0|-1.14|0.64|||negative binomial regression|Model testing whether condition predicted alcohol use days at 12-months||||.64|-1.14|.58
71907983|NCT03488914|143338434|SUPERIORITY||Slope|-0.45||||0.34|TWO_SIDED|95.0|-1.37|0.47|||negative binomial regression|Model testing whether condition predicted alcohol use days at 15-months||||.47|-1.37|.34
71907984|NCT00138424|143338449|SUPERIORITY_OR_OTHER||Spearman Correlation|0.24||||0.57|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.57
71907985|NCT00138424|143338449|SUPERIORITY_OR_OTHER||Spearman Correlation|0.26||||0.53|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.53
71907986|NCT00138424|143338449|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.3||||0.62|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter||||0.62
71907987|NCT00138424|143338449|SUPERIORITY_OR_OTHER||Spearman Correlation|0.8||||0.1|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter||||0.10
71907988|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.07||||0.87|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.87
71907989|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.31||||0.46|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.46
71907990|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|-0.41||||0.49|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter||||0.49
71907991|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.87||||0.05|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter||||0.05
71907992|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.12||||0.78|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.78
71907993|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.52||||0.18|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.18
71907994|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter||||0.75
71907995|NCT00138424|143338450|SUPERIORITY_OR_OTHER||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter||||0.75
71681617|NCT02987972|142881461|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.73|0.98|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14||0.98|0.73|
71907996|NCT01056341|143338515|SUPERIORITY_OR_OTHER||||||<|0.0001||||||"P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.~P-value linked to the 3 mg/kg/day 6 months selected arm ."|One-sided Z-tests|One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance||The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0||||< 0.0001
71907997|NCT01056341|143338516|SUPERIORITY_OR_OTHER||||||<|0.0001||||||The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.|combination tests|Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes' adjustment.||"The objective is to test the superiority of the selected arm using the approach of Posch et al.~The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm."||||< 0.0001
71907998|NCT01583452|143338520|SUPERIORITY_OR_OTHER|||||||0.665|TWO_SIDED||||||Kaplan-Meier survival analysis|||With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.||||0.665
71907999|NCT01583452|143338521|SUPERIORITY_OR_OTHER|||||||0.094|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.094
71908000|NCT01583452|143338522|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.059
71908001|NCT01583452|143338523|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Kaplan-Meier survival analysis|||||||0.830
71908002|NCT03103906|143338536|OTHER||Difference in proportion|2.56||||0.3334|TWO_SIDED|95.0|-19.99|25.07|||Chi-squared|||||25.07|-19.99|0.3334
71908003|NCT03571256|143338544|OTHER||LS mean difference|-0.8||||0.6|TWO_SIDED|95.0|-3.9|2.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||||2.3|-3.9|0.600
71908004|NCT00868452|143338555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|1.25||0.005|||||||Mixed Models Analysis|||||||0.005
71908005|NCT00868452|143338556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.15||0.003|||||||Mixed Models Analysis|||||||0.003
71908006|NCT00868452|143338557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|STANDARD_ERROR_OF_MEAN|1.01||0.012|||||||ANCOVA|||||||0.012
71908007|NCT01512108|143338582|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.27||||0.0026||95.0|-0.44|-0.09|||ANOVA|||||-0.09|-0.44|0.0026
71908008|NCT01512108|143338583|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.3||||0.0458||95.0|-0.6|-0.01|||ANOVA|||||-0.01|-0.60|0.0458
71908009|NCT03864536|143338607|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
71681618|NCT02987972|142881461|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C||1.24|0.93|
71908010|NCT03864536|143338608|SUPERIORITY||||||<|0.05||||||The statistical significance level was set using alpha of 0.05 without multiplicity correction. This pilot study was not powered for all the outcomes so the magnitude and estimates of intervention efficacy was of primary interest.|Mixed Models Analysis|||||||<0.05
71908011|NCT00640146|143338609|OTHER|||||||0.0213|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 2 hours of the first dose of study drug, testing MNTX against placebo.||||0.0213
71908012|NCT00640146|143338610|OTHER|||||||0.0463|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 4 hours of the first dose of study drug, testing MNTX against placebo.||||0.0463
71908013|NCT01357980|143338622|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.54||||0.11|TWO_SIDED|95.0|-3.47|0.39||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.39|-3.47|0.11
71908014|NCT01357980|143338622|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.61||||0.07|TWO_SIDED|95.0|-1.27|0.05||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.||0.05|-1.27|0.07
71908015|NCT01357980|143338623|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|219.5|||<|0.01|TWO_SIDED|95.0|69.6|369.5|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||369.5|69.6|<0.01
71908016|NCT01357980|143338623|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|224.1|||<|0.01|TWO_SIDED|95.0|140.9|307.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||307.4|140.9|<0.01
71681619|NCT02987972|142881461|OTHER||GMC Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A||0.93|0.72|
71908017|NCT01357980|143338623|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|117.0||||0.09||95.0|-20.0|254.0|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||254.0|-20.0|0.09
71908018|NCT01357980|143338623|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|223.7|||<|0.01|TWO_SIDED|95.0|94.3|353.1|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||353.1|94.3|<0.01
71908019|NCT01357980|143338623|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|138.5||||0.01|TWO_SIDED|95.0|34.7|242.2|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||242.2|34.7|0.01
71908020|NCT01357980|143338623|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|186.3|||<|0.01|TWO_SIDED|95.0|53.2|319.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.||319.4|53.2|<0.01
71908021|NCT01357980|143338624|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-23.8||||0.25|TWO_SIDED|95.0|-66.6|18.9|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||18.9|-66.6|0.25
71681620|NCT02987972|142881461|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.03|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F||1.03|0.79|
71681621|NCT02987972|142881461|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.08|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F||1.08|0.79|
71908022|NCT01357980|143338624|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-67.1|||<|0.01|TWO_SIDED|95.0|-112.9|-21.2|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-21.2|-112.9|<0.01
71908023|NCT01357980|143338624|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-35.1||||0.03|TWO_SIDED|95.0|-65.6|-4.6|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-4.6|-65.6|0.03
71908024|NCT01357980|143338624|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-51.0||||0.01|TWO_SIDED|95.0|-89.5|-12.4|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-12.4|-89.5|0.01
71908025|NCT01357980|143338624|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-32.3|||<|0.01|TWO_SIDED|95.0|-53.7|-11.0|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-11.0|-53.7|<0.01
71908026|NCT01357980|143338624|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-45.3|||<|0.01|TWO_SIDED|95.0|-76.6|-14.1|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.||-14.1|-76.6|<0.01
71908027|NCT01357980|143338625|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.7||||0.05||95.0|||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
71681622|NCT02987972|142881461|OTHER||GMC Ratio|131.23|||||TWO_SIDED|95.0|114.05|151.0|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F||151.00|114.05|
71681623|NCT02987972|142881461|OTHER||GMC Ratio|78.99|||||TWO_SIDED|95.0|69.82|89.36|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F||89.36|69.82|
71681624|NCT05365958|142881497|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
71681625|NCT05365958|142881498|SUPERIORITY||||||<|0.001|||||||Repeated Measures t-test of differences|||||||<.001
71681626|NCT04676412|142881505|OTHER|Percent difference and 95% CI were calculated using Miettinen and Nurminen method with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Difference in percentage|-8.4||||0.79262|TWO_SIDED|95.0|-27.4|11.9|||Stratified Miettinen and Nurminen|One-sided p-value for testing. H0: difference in percentage =0 versus H1: difference in percentage \> 0||||11.9|-27.4|0.79262
71908028|NCT01357980|143338625|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
71908029|NCT01357980|143338626|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.3||||0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.01
71908030|NCT01357980|143338626|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.8|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
71908031|NCT01357980|143338627|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|1.9||||0.05|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||0.05
71908032|NCT01357980|143338627|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|2.1|||<|0.01|||||||Satterthwaite-Welch's t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.||||<0.01
71681627|NCT04676412|142881508|OTHER|Difference in LS means and 95% CI were calculated using the Constrained longitudinal data analysis (cLDA) model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in Least Square (LS) Means|-0.25||||0.9519|TWO_SIDED|95.0|-8.59|8.09|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||8.09|-8.59|0.9519
71688738|NCT03951753|142892914|OTHER||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.107|<|0.001|TWO_SIDED|95.0|0.87|1.29|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.29|0.87|<0.001
71908033|NCT01357980|143338628|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.13|||<|0.01|TWO_SIDED|95.0|-1.91|-0.35|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.35|-1.91|<0.01
71908034|NCT01357980|143338628|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.18||||0.7|TWO_SIDED|95.0|-1.26|0.9|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.90|-1.26|0.7
71908035|NCT01357980|143338628|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.52||||0.3|TWO_SIDED|95.0|-1.56|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.56|0.3
71908036|NCT01357980|143338628|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.48||||0.3|TWO_SIDED|95.0|-1.47|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.52|-1.47|0.3
71908037|NCT01357980|143338628|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-1.38|||<|0.01|TWO_SIDED|95.0|-2.02|-0.73|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||-0.73|-2.02|<0.01
71908038|NCT01357980|143338628|SUPERIORITY_OR_OTHER_LEGACY||Mean Treatment Difference|-0.4||||0.4|TWO_SIDED|95.0|-1.35|0.55|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.||0.55|-1.35|0.4
71908039|NCT00873288|143338650|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||t-test, 2 sided|||||||> 0.05
71908040|NCT00873288|143338652|SUPERIORITY|||||||0.207|||||||Chi-squared|The Pearson Chi-squared value = 1.590||||||0.207
71908041|NCT00873288|143338653|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||t-test, 2 sided|||||||0.66
71908042|NCT04131933|143338658|SUPERIORITY|It was hypothesized that there would be a 50% reduction in Oncotype DX assay requests following the intervention.||||||0.37|||||||Fisher Exact|Fisher's exact test to compare number of patients with Oncotype DX ordered at 0-6 months (pre-intervention) vs 7-12 months (post-intervention)||Pre-Intervention (Period 1 and Period 2) vs Post-Intervention (Period 3 and Period 4)||||0.37
71908043|NCT04295356|143338682|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of Cmax was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|102.6|||||TWO_SIDED|90.0|94.08|111.9|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in Cmax between CT-P17 AI and CT-P17 PFS||111.90|94.08|
71908044|NCT04295356|143338683|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-inf was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|103.64|||||TWO_SIDED|90.0|93.98|114.29|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-inf between CT-P17 AI and CT-P17 PFS||114.29|93.98|
71908045|NCT04295356|143338684|EQUIVALENCE|The 90% confidence interval of the ratio of geometric least squares means of AUC0-last was estimated to assess the PK similarity between CT-P17 AI and CT-P17 PFS (bioequivalence margin of 80% to 125%).|Ratio of geometric least squares means|105.36|||||TWO_SIDED|90.0|91.09|121.86|||ANCOVA|The stratification factors (gender \[male or female\], study center, and body weight as measured on Day -1) were included in ANCOVA model as covariates.||Equivalence test in AUC0-last between CT-P17 AI and CT-P17 PFS||121.86|91.09|
71908046|NCT01106391|143338692|SUPERIORITY_OR_OTHER_LEGACY||Rate of technical success (%)|90.0|||||TWO_SIDED|95.0|79.5|96.2|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||96.2|79.5|
71908047|NCT01106391|143338693|SUPERIORITY_OR_OTHER_LEGACY||Rate of achieved primary safety(%)|97.0|||||TWO_SIDED|95.0|88.1|99.6|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.||99.6|88.1|
71908048|NCT04268004|143338707|OTHER|Chi-squared test was used to determine if study arm is associated with FP uptake.|||||=|0.64|||||||Chi-squared|df=(1, 19)||Chi-square test was used to determine if study arm is associated with FP uptake.||||=.64
71908049|NCT03783442|143338712|SUPERIORITY||Stratified Hazard Ratio|0.66|||<|0.0001|TWO_SIDED|95.0|0.54|0.8|||Stratified Log-rank Test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.80|0.54|<0.0001
71908050|NCT03783442|143338713|SUPERIORITY||Stratified Hazard Ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.75|0.52|<0.0001
71908051|NCT03783442|143338714|SUPERIORITY||Odds Ratio (OR)|2.38|||<|0.0001|TWO_SIDED|95.0|1.73|3.27|||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.|||3.27|1.73|<0.0001
71908052|NCT03783442|143338715|SUPERIORITY||Stratified Hazard Ratio|0.62||||0.0029|TWO_SIDED|95.0|0.44|0.87|||Stratified Log-rank test|One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.|Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.|||0.87|0.44|0.0029
71908053|NCT03783442|143338717|SUPERIORITY||Least Squares (LS) Mean Difference|4.4||||0.1372|TWO_SIDED|95.0|-1.4|10.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Dysphagia Score at Cycle 6||10.3|-1.4|0.1372
71908054|NCT03783442|143338717|SUPERIORITY||LS Mean Difference|0.6||||0.713|TWO_SIDED|95.0|-2.5|3.7|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Eating Score at Cycle 6||3.7|-2.5|0.7130
71908055|NCT03783442|143338717|SUPERIORITY||LS Mean Difference|-1.4||||0.3001|TWO_SIDED|95.0|-4.1|1.3|||Mixed Models Analysis|Two-sided p-value estimated from a mixed effect model|Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Reflux Score at Cycle 6||1.3|-4.1|0.3001
71908056|NCT03783442|143338717|OTHER||LS Mean Difference|-1.9|||||TWO_SIDED|95.0|-3.9|0.2|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Pain Score at Cycle 6||0.2|-3.9|
71908057|NCT03783442|143338717|OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-2.1|1.4|||||Based on a mixed effect model analysis with QLQ-OES18 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in EORTC QLQ-OES18 Index Score at Cycle 6||1.4|-2.1|
71908058|NCT03783442|143338718|OTHER||LS Mean Difference|3.3|||||TWO_SIDED|95.0|0.4|6.2|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6||6.2|0.4|
71862149|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.344||0.3089|TWO_SIDED|90.0|-0.74|0.39||One-sided p-value|ANCOVA|||Week 2 Average Pain||0.39|-0.74|0.3089
71862150|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.407||0.6124|TWO_SIDED|90.0|-0.55|0.79||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.79|-0.55|0.6124
71908059|NCT03783442|143338718|OTHER||LS Mean Difference|2.6|||||TWO_SIDED|95.0|0.0|5.1|||||Based on a mixed effect model analysis, with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|Analysis of Change from Baseline in Physical Functioning at Cycle 6||5.1|0.0|
71908060|NCT03783442|143338719|OTHER||LS Mean Difference|-1.4|||||TWO_SIDED|95.0|-4.7|1.9|||||Based on a mixed effect model analysis with QLQ-C30 scores until cycle 18 as the response variable, and treatment by study visit interaction, Baseline mean score, and randomization stratification factors as covariates.|||1.9|-4.7|
71908061|NCT04190186|143338722|SUPERIORITY||Mean Difference (Final Values)|0.49||||0.594|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.594
71908062|NCT04015440|143338737|OTHER|Linear Regression|||||<|0.001|||||||Regression, Linear|||||||<.001
71688739|NCT03951753|142892914|OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.166|<|0.001|TWO_SIDED|95.0|1.59|2.24|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||2.24|1.59|<0.001
71862151|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|0.395||0.1003|TWO_SIDED|90.0|-1.15|0.14||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.14|-1.15|0.1003
71862152|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.408||0.6875|TWO_SIDED|90.0|-0.47|0.87||One-sided p-value|ANCOVA|||Week 4 Average Pain||0.87|-0.47|0.6875
71862153|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.51|STANDARD_ERROR_OF_MEAN|0.427||0.8833|TWO_SIDED|90.0|-0.19|1.21||One-sided p-value|ANCOVA|||Week 6 Average Pain||1.21|-0.19|0.8833
71862154|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.43|STANDARD_ERROR_OF_MEAN|0.413||0.1502|TWO_SIDED|90.0|-1.11|0.25||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.25|-1.11|0.1502
71862155|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.428||0.6788|TWO_SIDED|90.0|-0.5|0.9||One-sided p-value|ANCOVA|||Week 6 Average Pain||0.90|-0.50|0.6788
71862156|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.441||0.6835|TWO_SIDED|90.0|-0.51|0.94||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.94|-0.51|0.6835
71862157|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.425||0.2237|TWO_SIDED|90.0|-1.02|0.38||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.38|-1.02|0.2237
71862158|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.439||0.7234|TWO_SIDED|90.0|-0.46|0.98||One-sided p-value|ANCOVA|||Week 8 Average Pain||0.98|-0.46|0.7234
71862159|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.424||0.4773|TWO_SIDED|90.0|-0.72|0.67||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.67|-0.72|0.4773
71862160|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.41||0.0818|TWO_SIDED|90.0|-1.25|0.1||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.10|-1.25|0.0818
71862161|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.424||0.6397|TWO_SIDED|90.0|-0.55|0.85||One-sided p-value|ANCOVA|||Week 12 Average Pain||0.85|-0.55|0.6397
71862162|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|0.03|STANDARD_ERROR_OF_MEAN|0.428||0.5321|TWO_SIDED|90.0|-0.67|0.74||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.74|-0.67|0.5321
71862163|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.89|STANDARD_ERROR_OF_MEAN|0.42||0.0167|TWO_SIDED|90.0|-1.59|-0.2||One-sided p-value|ANCOVA|||Week 16 Average Pain||-0.20|-1.59|0.0167
71862164|NCT04092452|143239566|SUPERIORITY||Risk Difference (RD)|-0.37|STANDARD_ERROR_OF_MEAN|0.434||0.1963|TWO_SIDED|90.0|-1.09|0.34||One-sided p-value|ANCOVA|||Week 16 Average Pain||0.34|-1.09|0.1963
71862165|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|-2.2|STANDARD_ERROR_OF_MEAN|4.98|||TWO_SIDED|90.0|-10.3|6.0||||||Week 1||6.0|-10.3|
71862166|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|2.0|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-7.3|11.3||||||Week 1||11.3|-7.3|
71862167|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|6.8|STANDARD_ERROR_OF_MEAN|6.47|||TWO_SIDED|90.0|-3.9|17.4||||||Week 1||17.4|-3.9|
71862168|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|10.7|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-2.0|23.4||||||Week 2||23.4|-2.0|
71862169|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|7.34|||TWO_SIDED|90.0|-4.5|19.7||||||Week 2||19.7|-4.5|
71862170|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|7.5|STANDARD_ERROR_OF_MEAN|7.36|||TWO_SIDED|90.0|-4.6|19.6||||||Week 2||19.6|-4.6|
71862171|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|7.4|STANDARD_ERROR_OF_MEAN|7.95|||TWO_SIDED|90.0|-5.7|20.5||||||Week 4||20.5|-5.7|
71862172|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|15.1|STANDARD_ERROR_OF_MEAN|8.33|||TWO_SIDED|90.0|1.4|28.7||||||Week 4||28.7|1.4|
71862173|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|4.8|STANDARD_ERROR_OF_MEAN|7.74|||TWO_SIDED|90.0|-8.0|17.5||||||Week 4||17.5|-8.0|
71862174|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|14.3|STANDARD_ERROR_OF_MEAN|8.3|||TWO_SIDED|90.0|0.7|28.0||||||Week 6||28.0|0.7|
71862175|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|10.9|STANDARD_ERROR_OF_MEAN|7.96|||TWO_SIDED|90.0|-2.2|24.0||||||Week 6||24.0|-2.2|
71862176|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|10.6|STANDARD_ERROR_OF_MEAN|8.06|||TWO_SIDED|90.0|-2.6|23.9||||||Week 6||23.9|-2.6|
71908063|NCT04015440|143338738|OTHER|Regression||||||0.027|||||||Regression, Linear|||||||.027
71908064|NCT04015440|143338739|OTHER|Logistic Regression||||||0.004|||||||Regression, Logistic|||||||.004
71908065|NCT00830960|143338768|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference in PRU|-183.0|||<|0.0001|TWO_SIDED|95.0|-229.0|-137.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-137|-229|<0.0001
71681628|NCT04676412|142881509|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|8.81||||0.0628|TWO_SIDED|95.0|-0.49|18.11|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||18.11|-0.49|0.0628
71681629|NCT04676412|142881510|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|3.59||||0.3298|TWO_SIDED|95.0|-3.7|10.87|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.87|-3.70|0.3298
71681630|NCT04676412|142881511|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-0.28||||0.9594|TWO_SIDED|95.0|-11.32|10.75|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||10.75|-11.32|0.9594
71908066|NCT00830960|143338768|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-139.0|||<|0.0001|TWO_SIDED|95.0|-177.0|-102.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.||||-102|-177|<0.0001
71908067|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-57.0||||0.0058|TWO_SIDED|95.0|-97.0|-17.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-17|-97|0.0058
71908068|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-35.0||||0.0365|TWO_SIDED|95.0|-68.0|-2.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel"|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-2|-68|0.0365
71908069|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-68.0||||0.0004|TWO_SIDED|95.0|-104.0|-32.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-32|-104|0.0004
71908070|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-160.0|||<|0.0001|TWO_SIDED|95.0|-211.0|-110.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-110|-211|<0.0001
71908071|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-115.0|||<|0.0001|TWO_SIDED|95.0|-156.0|-73.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-156|<0.0001
71908072|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-171.0|||<|0.0001|TWO_SIDED|95.0|-216.0|-125.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-125|-216|<0.0001
71908073|NCT00830960|143338769|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-212.0|||<|0.0001|TWO_SIDED|95.0|-259.0|-167.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-167|-259|<0.0001
71908074|NCT00830960|143338770|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-119.0|||<|0.0001|TWO_SIDED|95.0|-166.0|-73.0||"P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|LS Mean Difference in PRU|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-166|<0.0001
71908075|NCT00830960|143338770|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-113.0|||<|0.0001|TWO_SIDED|95.0|-154.0|-73.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-73|-154|<0.0001
71908076|NCT00830960|143338770|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-85.0|||<|0.0001|TWO_SIDED|95.0|-121.0|-48.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-48|-121|<0.0001
71908077|NCT00830960|143338770|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-35.0||||0.0647|TWO_SIDED|95.0|-72.0|2.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||2|-72|0.0647
71908078|NCT00830960|143338770|SUPERIORITY_OR_OTHER||LS Mean Difference in PRU|-100.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-57.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-57|-143|<0.0001
71908079|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|15.0||||0.0072|TWO_SIDED|95.0|4.0|27.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|4|0.0072
71908080|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|9.0||||0.0647|TWO_SIDED|95.0|-1.0|18.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||18|-1|0.0647
71908081|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.0054|TWO_SIDED|95.0|3.0|19.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||19|3|0.0054
71908082|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|51.0|||<|0.0001|TWO_SIDED|95.0|36.0|66.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||66|36|<0.0001
71908083|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|36.0|||<|0.0001|TWO_SIDED|95.0|23.0|48.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||48|23|<0.0001
71908084|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|49.0|||<|0.0001|TWO_SIDED|95.0|36.0|61.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||61|36|<0.0001
71908085|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|62.0|||<|0.0001|TWO_SIDED|95.0|47.0|76.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||76|47|<0.0001
71908086|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|48.0|||<|0.0001|TWO_SIDED|95.0|36.0|59.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||59|36|<0.0001
71908087|NCT00830960|143338771|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|56.0|||<|0.0001|TWO_SIDED|95.0|44.0|68.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||68|44|<0.0001
71908088|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|38.0|||<|0.0001|TWO_SIDED|95.0|27.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|27|<0.0001
71688740|NCT03951753|142892914|OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.192|<|0.001|TWO_SIDED|95.0|0.46|1.21|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||1.21|0.46|<0.001
71688741|NCT03951753|142892915|OTHER||Least Squares Mean Difference|-38.1|||<|0.001|TWO_SIDED|95.0|-45.4|-30.7|||ANCOVA|||||-30.7|-45.4|<0.001
71688742|NCT03951753|142892915|OTHER||Least Squares Mean Difference|-47.1|||<|0.001|TWO_SIDED|95.0|-54.6|-39.5|||ANCOVA|||||-39.5|-54.6|<0.001
71862177|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|10.1|STANDARD_ERROR_OF_MEAN|8.38||0.1162|TWO_SIDED|90.0|-3.6|23.9||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||23.9|-3.6|0.1162
71862178|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|13.1|STANDARD_ERROR_OF_MEAN|8.43||0.0642|TWO_SIDED|90.0|-0.8|27.0||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||27.0|-0.8|0.0642
71862179|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|8.1|STANDARD_ERROR_OF_MEAN|8.36||0.1664|TWO_SIDED|90.0|-5.7|21.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 8||21.8|-5.7|0.1664
71862180|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|7.2|STANDARD_ERROR_OF_MEAN|8.1||0.1882|TWO_SIDED|90.0|-6.1|20.5||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||20.5|-6.1|0.1882
71862181|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.43||0.0423|TWO_SIDED|90.0|1.1|28.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||28.8|1.1|0.0423
71862182|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|3.3|STANDARD_ERROR_OF_MEAN|7.9||0.3396|TWO_SIDED|90.0|-9.7|16.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 12||16.3|-9.7|0.3396
71908089|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|21.0|42.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||42|21|<0.0001
71908090|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|17.0||||0.0026|TWO_SIDED|95.0|6.0|28.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||28|6|0.0026
71862183|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|2.7|STANDARD_ERROR_OF_MEAN|7.35||0.3584|TWO_SIDED|90.0|-9.4|14.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||14.8|-9.4|0.3584
71862184|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|14.9|STANDARD_ERROR_OF_MEAN|8.17||0.0367|TWO_SIDED|90.0|1.5|28.3||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||28.3|1.5|0.0367
71862185|NCT04092452|143239567|SUPERIORITY||Risk Difference (RD)|5.2|STANDARD_ERROR_OF_MEAN|7.65||0.2486|TWO_SIDED|90.0|-7.4|17.8||One-sided p-value|MR weighting strategy|P-value method for risk difference (RD) was minimum risk (MR) weighting strategy by Mehrotra and Railkar (2000).||Week 16||17.8|-7.4|0.2486
71862186|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
71862187|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
71862188|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
71862189|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
71862190|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
71862191|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
71862192|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
71862193|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
71862194|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
71862195|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
71688743|NCT03951753|142892915|OTHER||Least Squares Mean Difference|-9.0||||0.006|TWO_SIDED|95.0|-15.4|-2.6|||ANCOVA|||||-2.6|-15.4|0.006
71862196|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
71862197|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
71862198|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
71862199|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
71862200|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
71862201|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
71862202|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
71908091|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|37.0|||<|0.0001|TWO_SIDED|95.0|24.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||50|24|<0.0001
71908092|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|35.0||||0.0001|TWO_SIDED|95.0|18.0|52.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||52|18|0.0001
71908093|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|28.0||||0.0005|TWO_SIDED|95.0|13.0|44.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||44|13|0.0005
71908094|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|11.0||||0.1898|TWO_SIDED|95.0|-5.0|27.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||27|-5|0.1898
71908095|NCT00830960|143338772|SUPERIORITY_OR_OTHER||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|TWO_SIDED|95.0|18.0|45.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||45|18|<0.0001
71908096|NCT00830960|143338774|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-110.0|||<|0.0001|TWO_SIDED|95.0|-143.0|-76.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-76|-143|<0.0001
71908097|NCT00830960|143338774|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-92.0|||<|0.0001|TWO_SIDED|95.0|-123.0|-60.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-60|-123|<0.0001
71908098|NCT00830960|143338774|SUPERIORITY_OR_OTHER||LS mean difference in PRU|-51.0||||0.002|TWO_SIDED|95.0|-83.0|-19.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.||||-19|-83|0.0020
71908099|NCT00830960|143338781|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
71908100|NCT00830960|143338781|SUPERIORITY_OR_OTHER|||||||0.427||95.0|||||Fisher Exact|||||||0.427
71908101|NCT00830960|143338781|SUPERIORITY_OR_OTHER|||||||0.683||95.0|||||Fisher Exact|||||||0.683
71908102|NCT00830960|143338781|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Fisher Exact|||||||0.034
71908103|NCT02855450|143338788|SUPERIORITY||Least square means difference|4.7||||0.04|TWO_SIDED|95.0|0.2|9.2|||ANCOVA|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.||These statistics refer to Day 7 and primary eye||9.2|0.2|0.040
71908104|NCT02855450|143338788|SUPERIORITY||least square mean difference|2.4||||0.457|TWO_SIDED|95.0|-4.1|9.0||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 28 and primary eye||9.0|-4.1|0.457
71908105|NCT02855450|143338788|SUPERIORITY||least square mean difference|4.0||||0.283|TWO_SIDED|95.0|-3.5|11.5||Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|ANCOVA|||These statistics refer to Day 56 and primary eye||11.5|-3.5|0.283
71908106|NCT02855450|143338788|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|Least square means difference|3.5||||0.147|TWO_SIDED|95.0|-1.3|8.3|||ANCOVA|||These statistics refer to Day 7 and secondary eye||8.3|-1.3|0.147
71908107|NCT02855450|143338788|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|3.0||||0.421|TWO_SIDED|95.0|-4.4|10.4|||ANCOVA|||These statistics refer to Day 28 and secondary eye||10.4|-4.4|0.421
71908108|NCT02855450|143338788|SUPERIORITY|Analysis results are obtained from an ANCOVA with treatment as factor and baseline value as covariate.|least square mean difference|4.3||||0.327|TWO_SIDED|95.0|-4.4|13.0|||ANCOVA|||These statistics refer to Day 56 and secondary eye||13.0|-4.4|0.327
71908109|NCT02703987|143338793|SUPERIORITY||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0801|TWO_SIDED|95.0|-0.04|0.67|||Mixed Models Analysis|||||0.67|-0.04|0.0801
71688744|NCT03951753|142892916|OTHER||Least Squares Mean Difference|-14696.1|||<|0.001|TWO_SIDED|95.0|-17045.0|-12347.3|||ANCOVA|||||-12347.3|-17045.0|<0.001
71681631|NCT04676412|142881512|OTHER|Difference in LS means and 95% CI were calculated using the cLDA model with covariates for treatment by study visit interaction \& stratified by ECOG performance status (0 versus 1) and baseline PD-L1 Status (1% to 49% versus \>=50%).|Difference in LS Means|-5.53||||0.162|TWO_SIDED|95.0|-13.37|2.31|||cLDA model|Two-sided p-value based on cLDA model with covariates for treatment by study visit interaction; stratified by ECOG and baseline PDL-1.||||2.31|-13.37|0.1620
71688745|NCT03951753|142892916|OTHER||Least Squares Mean Difference|-17873.2|||<|0.001|TWO_SIDED|95.0|-20239.0|-15507.4|||ANCOVA|||||-15507.4|-20239.0|<0.001
71908110|NCT02703987|143338794|SUPERIORITY||Mean Difference (Net)|0.34|STANDARD_ERROR_OF_MEAN|0.18||0.0714|TWO_SIDED|95.0|-0.03|0.71|||Mixed Models Analysis|||||0.71|-0.03|0.0714
71908111|NCT02703987|143338795|SUPERIORITY||Mean Difference (Net)|9.56|STANDARD_ERROR_OF_MEAN|4.85||0.0609|TWO_SIDED|95.0|-0.48|19.6|||Mixed Models Analysis|||||19.6|-0.48|0.0609
71908112|NCT01309841|143338809|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.062|1.795|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.795|1.062|0.015
71908113|NCT01309841|143338809|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.509||||0.001|TWO_SIDED|95.0|1.168|1.949|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).||1.949|1.168|0.001
71908114|NCT01309841|143338810|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.479||||0.028|TWO_SIDED|95.0|1.038|2.107||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.107|1.038|0.028
71908115|NCT01309841|143338810|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.691||||0.002|TWO_SIDED|95.0|1.205|2.373||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel|||||2.373|1.205|0.002
71908116|NCT01309841|143338812|SUPERIORITY_OR_OTHER||LS mean difference|0.55|||<|0.001|TWO_SIDED|95.0|0.24|0.86|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.86|0.24|<0.001
71908117|NCT01309841|143338812|SUPERIORITY_OR_OTHER||Ls mean difference|0.82|||<|0.001|TWO_SIDED|95.0|0.51|1.13|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||1.13|0.51|<0.001
71908118|NCT01309841|143338813|SUPERIORITY_OR_OTHER||LS mean difference|-0.09||||0.176|TWO_SIDED|95.0|-0.23|0.04|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.04|-0.23|0.176
71908119|NCT01309841|143338813|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.008|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.05|-0.32|0.008
71908120|NCT01309841|143338814|SUPERIORITY_OR_OTHER||LS mean difference|0.05||||0.564|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.23|-0.12|0.564
71908121|NCT01309841|143338814|SUPERIORITY_OR_OTHER||LS mean difference|0.18||||0.042|TWO_SIDED|95.0|0.01|0.36|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.36|0.01|0.042
71908122|NCT01309841|143338815|SUPERIORITY_OR_OTHER||LS mean difference|3.87||||0.094|TWO_SIDED|95.0|-0.66|8.39|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||8.39|-0.66|0.094
71908123|NCT01309841|143338815|SUPERIORITY_OR_OTHER||LS mean difference|8.59|||<|0.001|TWO_SIDED|95.0|4.04|13.14|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||13.14|4.04|<0.001
71908124|NCT01309841|143338816|SUPERIORITY_OR_OTHER||LS mean difference|0.54||||0.011|TWO_SIDED|95.0|0.12|0.96|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||0.96|0.12|0.011
71908125|NCT01309841|143338816|SUPERIORITY_OR_OTHER||LS mean difference|0.99|||<|0.001|TWO_SIDED|95.0|0.57|1.41|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.||1.41|0.57|<0.001
71908126|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.08||||0.273|TWO_SIDED|95.0|-0.21|0.06||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.21|0.273
71908127|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.12||||0.089|TWO_SIDED|95.0|-0.26|0.02||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.02|-0.26|0.089
71908128|NCT01309841|143338818|SUPERIORITY_OR_OTHER||Slope|0.02||||0.849|TWO_SIDED|95.0|-0.14|0.17||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.17|-0.14|0.849
71908129|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.03||||0.749|TWO_SIDED|95.0|-0.18|0.13||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.13|-0.18|0.749
71908130|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.13||||0.062|TWO_SIDED|95.0|-0.26|0.01||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.26|0.062
71862203|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
71862204|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
71862205|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
71862206|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
71862207|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
71862208|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
71862209|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
71862210|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
71862211|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
71862212|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
71862213|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
71862214|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
71862215|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
71862216|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
71862217|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
71862218|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
71862219|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
71862220|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
71862221|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
71862222|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
71862223|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
71908131|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.21||||0.003|TWO_SIDED|95.0|-0.35|-0.07||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||-0.07|-0.35|0.003
71862224|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
71862225|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
71862226|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
71862227|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
71862228|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
71862229|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
71862230|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
71862231|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
71862232|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
71862233|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
71862234|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
71862235|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
71862236|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
71862237|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
71681632|NCT04676412|142881513|OTHER|HR and 95% CI were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.03||||0.9419|TWO_SIDED|95.0|0.47|2.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.26|0.47|0.9419
71908132|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.11||||0.202|TWO_SIDED|95.0|-0.29|0.06||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.06|-0.29|0.202
71908133|NCT01309841|143338818|SUPERIORITY_OR_OTHER||LS mean difference|-0.16||||0.072|TWO_SIDED|95.0|-0.34|0.01||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.||0.01|-0.34|0.072
71908134|NCT01309841|143338819|SUPERIORITY_OR_OTHER||LS mean difference|-0.02||||0.831|TWO_SIDED|95.0|-0.25|0.2|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.20|-0.25|0.831
71908135|NCT01309841|143338819|SUPERIORITY_OR_OTHER||LS mean difference|-0.18||||0.141|TWO_SIDED|95.0|-0.41|0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.||0.06|-0.41|0.141
71908136|NCT00643604|143338821|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||0.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.69
71908137|NCT00643604|143338822|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71908138|NCT00643604|143338823|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
71908139|NCT00643604|143338824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0||||p value for Symptom Score|Wilcoxon signed rank test|||Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
71908140|NCT00643604|143338824|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0||||p value for Activity Score.|Wilcoxon signed rank test|||Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71862238|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
71908141|NCT00643604|143338824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||95.0|||||Wilcoxon signed-rank test|||Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.31
71908142|NCT00643604|143338824|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||"Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.~Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values."||||0.13
71908143|NCT00643604|143338825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
71862239|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
71862240|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
71862241|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
71908144|NCT00643604|143338825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||95.0|||||Wilcoxon signed-rank test|||Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.19
71908145|NCT00643604|143338825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Wilcoxon signed-rank test|||Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.03
71908146|NCT00643604|143338825|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
71681633|NCT04676412|142881514|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.01||||0.9789|TWO_SIDED|95.0|0.43|2.38|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.38|0.43|0.9789
71681634|NCT04676412|142881515|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.08||||0.8856|TWO_SIDED|95.0|0.36|3.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.28|0.36|0.8856
71862242|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
71862243|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
71908147|NCT00643604|143338826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon signed-rank test|||Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
71908148|NCT00643604|143338826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||Wilcoxon signed-rank test|||Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.06
71681635|NCT04676412|142881516|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.55||||0.3264|TWO_SIDED|95.0|0.64|3.75|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||3.75|0.64|0.3264
71862244|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
71862245|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
71862246|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
71862247|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
71908149|NCT00643604|143338826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Wilcoxon signed-rank test|||Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.63
71862248|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
71862249|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
71862250|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
71862251|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
71862252|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
71862253|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
71862254|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
71862255|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
71862256|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
71862257|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
71862258|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
71862259|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
71862260|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
71862261|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
71862262|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
71862263|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
71862264|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
71862265|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
71862266|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
71862267|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
71688746|NCT03951753|142892916|OTHER||Least Squares Mean Difference|-3177.1||||0.002|TWO_SIDED|95.0|-5194.3|-1159.8|||ANCOVA|||||-1159.8|-5194.3|0.002
71862268|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
71862269|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
71862270|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
71862271|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
71862272|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
71862273|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
71862274|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
71862275|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
71862276|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
71908150|NCT00643604|143338826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88||95.0|||||Wilcoxon signed-rank test|||Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.88
71908151|NCT00643604|143338826|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13||95.0|||||Wilcoxon signed-rank test|||Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.13
71862277|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
71862278|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
71862279|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
71862280|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
71862281|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
71862282|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
71862283|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
71862284|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
71862285|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
71908152|NCT00643604|143338827|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.5
71862286|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
71862287|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
71862288|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
71862289|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
71862290|NCT04092452|143239573|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
71862291|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.69|0.29||||||Week 1-HSS0101-Pain At It's Worst||0.29|-0.69|
71862292|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.48|STANDARD_ERROR_OF_MEAN|0.287|||TWO_SIDED|90.0|-0.96|-0.01||||||Week 1-HSS0101-Pain At It's Worst||-0.01|-0.96|
71862293|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.42|STANDARD_ERROR_OF_MEAN|0.295|||TWO_SIDED|90.0|-0.91|0.06||||||Week 1-HSS0101-Pain At It's Worst||0.06|-0.91|
71862294|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.392|||TWO_SIDED|90.0|-0.95|0.35||||||Week 2-HSS0101-Pain At It's Worst||0.35|-0.95|
71862295|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.71|STANDARD_ERROR_OF_MEAN|0.377|||TWO_SIDED|90.0|-1.33|-0.08||||||Week 2-HSS0101-Pain At It's Worst||-0.08|-1.33|
71862296|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.391|||TWO_SIDED|90.0|-1.21|0.08||||||Week 2-HSS0101-Pain At It's Worst||0.08|-1.21|
71862297|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.481|||TWO_SIDED|90.0|-0.54|1.05||||||Week 4-HSS0101-Pain At It's Worst||1.05|-0.54|
71862298|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.39|STANDARD_ERROR_OF_MEAN|0.458|||TWO_SIDED|90.0|-1.15|0.37||||||Week 4-HSS0101-Pain At It's Worst||0.37|-1.15|
71862299|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.06|STANDARD_ERROR_OF_MEAN|0.478|||TWO_SIDED|90.0|-0.85|0.73||||||Week 4-HSS0101-Pain At It's Worst||0.73|-0.85|
71688747|NCT03951753|142892917|OTHER||Least Squares Mean Difference|-1.93|||<|0.001|TWO_SIDED|95.0|-2.18|-1.67|||Mixed Models Analysis|||||-1.67|-2.18|<0.001
71681636|NCT04676412|142881517|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.31||||0.4068|TWO_SIDED|95.0|0.7|2.46|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||2.46|0.70|0.4068
71681637|NCT04676412|142881518|OTHER|HR and 95% CI were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1) and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|7.81||||0.002|TWO_SIDED|95.0|1.71|35.62|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status and baseline PD-L1 status.||||35.62|1.71|0.0020
71681638|NCT04676412|142881519|OTHER|Hazard ratio (HR) and 95% confidence interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).|Hazard Ratio (HR)|1.18||||0.71084|TWO_SIDED|95.0|0.61|2.25|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||||2.25|0.61|0.71084
71681639|NCT04676412|142881520|OTHER||Hazard Ratio (HR)|1.53||||0.8197|TWO_SIDED|95.0|0.61|3.87|||Stratified Log Rank|One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of enrolling site and baseline PD-L1 status.||HR and 95% CIs were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 status (1-49% versus ≥50%).||3.87|0.61|0.81970
71862300|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.62|STANDARD_ERROR_OF_MEAN|0.524|||TWO_SIDED|90.0|-0.24|1.49||||||Week 6-HSS0101-Pain At It's Worst||1.49|-0.24|
71862301|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.19|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.03|0.64||||||Week 6-HSS0101-Pain At It's Worst||0.64|-1.03|
71862302|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.526|||TWO_SIDED|90.0|-0.66|1.08||||||Week 6-HSS0101-Pain At It's Worst||1.08|-0.66|
71908153|NCT00643604|143338828|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25||95.0|||||Wilcoxon sign-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.25
71908154|NCT00643604|143338829|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71908155|NCT00643604|143338830|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||0.50
71681640|NCT04765722|142881535|SUPERIORITY||% change relative to placebo|18.0||||0.99|TWO_SIDED|95.0|-46.4|160.1||The model included treatment group, week, the interaction between treatment group and week, and baseline log-transformed 24-hour cough frequency as fixed effects.|Generalized estimating equations|Hypothesis tests were two-sided, a p\<0.05 indicated statistical significance. We made no adjustments for multiple comparisons across outcomes.||The primary outcome was the change from baseline in log-transformed 24-hour cough frequency (coughs/hour) at week 14.||160.1|-46.4|0.99
71688748|NCT03951753|142892917|OTHER||Least Squares Mean Difference|-2.33|||<|0.001|TWO_SIDED|95.0|-2.58|-2.08|||Mixed Models Analysis|||||-2.08|-2.58|<0.001
71688749|NCT03951753|142892917|OTHER||Least Squares Mean Difference|-0.41|||<|0.001|TWO_SIDED|95.0|-0.63|-0.19|||Mixed Models Analysis|||||-0.19|-0.63|<0.001
71862303|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.558|||TWO_SIDED|90.0|-0.69|1.16||||||Week 8-HSS0101-Pain At It's Worst||1.16|-0.69|
71862304|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.539|||TWO_SIDED|90.0|-1.21|0.57||||||Week 8-HSS0101-Pain At It's Worst||0.57|-1.21|
71862305|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.565|||TWO_SIDED|90.0|-0.49|1.38||||||Week 8-HSS0101-Pain At It's Worst||1.38|-0.49|
71862306|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.578|||TWO_SIDED|90.0|-0.79|1.12||||||Week 12-HSS0101-Pain At It's Worst||1.12|-0.79|
71862307|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.68|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-1.59|0.23||||||Week 12-HSS0101-Pain At It's Worst||0.23|-1.59|
71862308|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.576|||TWO_SIDED|90.0|-0.88|1.03||||||Week 12-HSS0101-Pain At It's Worst||1.03|-0.88|
71862309|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.08|STANDARD_ERROR_OF_MEAN|0.631|||TWO_SIDED|90.0|-0.96|1.13||||||Week 16-HSS0101-Pain At It's Worst||1.13|-0.96|
71862310|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-1.25|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.24|-0.25||||||Week 16-HSS0101-Pain At It's Worst||-0.25|-2.24|
71908156|NCT00643604|143338831|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71908157|NCT00643604|143338832|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71908158|NCT00643604|143338833|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of \< 0.05 was considered statistically significant. No imputation was used for missing values.||||1.00
71862311|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.91|STANDARD_ERROR_OF_MEAN|0.628|||TWO_SIDED|90.0|-1.95|0.13||||||Week 16-HSS0101-Pain At It's Worst||0.13|-1.95|
71862312|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.47|0.48||||||Week 1-HSS0102-Tenderness At It's Worst||0.48|-0.47|
71862313|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.28|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.75|0.18||||||Week 1-HSS0102-Tenderness At It's Worst||0.18|-0.75|
71862314|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.31|STANDARD_ERROR_OF_MEAN|0.286|||TWO_SIDED|90.0|-0.78|0.17||||||Week 1-HSS0102-Tenderness At It's Worst||0.17|-0.78|
71862315|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.22|STANDARD_ERROR_OF_MEAN|0.361|||TWO_SIDED|90.0|-0.81|0.38||||||Week 2-HSS0102-Tenderness At It's Worst||0.38|-0.81|
71862316|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.347|||TWO_SIDED|90.0|-0.97|0.18||||||Week 2-HSS0102-Tenderness At It's Worst||0.18|-0.97|
71862317|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-1.05|0.14||||||Week 2-HSS0102-Tenderness At It's Worst||0.14|-1.05|
71862318|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.471|||TWO_SIDED|90.0|-0.56|1.0||||||Week 4-HSS0102-Tenderness At It's Worst||1.00|-0.56|
71862319|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.448|||TWO_SIDED|90.0|-0.99|0.49||||||Week 4-HSS0102-Tenderness At It's Worst||0.49|-0.99|
71862320|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.11|STANDARD_ERROR_OF_MEAN|0.468|||TWO_SIDED|90.0|-0.88|0.67||||||Week 4-HSS0102-Tenderness At It's Worst||0.67|-0.88|
71862321|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.48|STANDARD_ERROR_OF_MEAN|0.52|||TWO_SIDED|90.0|-0.38|1.34||||||Week 6-HSS0102-Tenderness At It's Worst||1.34|-0.38|
71862322|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.501|||TWO_SIDED|90.0|-1.06|0.6||||||Week 6-HSS0102-Tenderness At It's Worst||0.60|-1.06|
71862323|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.01|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-0.86|0.87||||||Week 6-HSS0102-Tenderness At It's Worst||0.87|-0.86|
71862324|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.542|||TWO_SIDED|90.0|-0.81|0.99||||||Week 8-HSS0102-Tenderness At It's Worst||0.99|-0.81|
71862325|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.25|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.11|0.62||||||Week 8-HSS0102-Tenderness At It's Worst||0.62|-1.11|
71862326|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.35|STANDARD_ERROR_OF_MEAN|0.549|||TWO_SIDED|90.0|-0.56|1.25||||||Week 8-HSS0102-Tenderness At It's Worst||1.25|-0.56|
71862327|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.554|||TWO_SIDED|90.0|-0.87|0.97||||||Week 12-HSS0102-Tenderness At It's Worst||0.97|-0.87|
71862328|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.49|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.36|0.38||||||Week 12-HSS0102-Tenderness At It's Worst||0.38|-1.36|
71862329|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.552|||TWO_SIDED|90.0|-0.9|0.93||||||Week 12-HSS0102-Tenderness At It's Worst||0.93|-0.90|
71862330|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.606|||TWO_SIDED|90.0|-0.96|1.04||||||Week 16-HSS0102-Tenderness At It's Worst||1.04|-0.96|
71862331|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-1.24|STANDARD_ERROR_OF_MEAN|0.577|||TWO_SIDED|90.0|-2.19|-0.29||||||Week 16-HSS0102-Tenderness At It's Worst||-0.29|-2.19|
71862332|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.603|||TWO_SIDED|90.0|-2.11|-0.11||||||Week 16-HSS0102-Tenderness At It's Worst||-0.11|-2.11|
71862333|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.284|||TWO_SIDED|90.0|-0.57|0.37||||||Week 1-HSS0103-Swelling At It's Worst||0.37|-0.57|
71862334|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.23|STANDARD_ERROR_OF_MEAN|0.278|||TWO_SIDED|90.0|-0.69|0.22||||||Week 1-HSS0103-Swelling At It's Worst||0.22|-0.69|
71862335|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.285|||TWO_SIDED|90.0|-0.94|0.01||||||Week 1-HSS0103-Swelling At It's Worst||0.01|-0.94|
71862336|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.24|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.83|0.35||||||Week 2-HSS0103-Swelling At It's Worst||0.35|-0.83|
71862337|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.46|STANDARD_ERROR_OF_MEAN|0.345|||TWO_SIDED|90.0|-1.03|0.11||||||Week 2-HSS0103-Swelling At It's Worst||0.11|-1.03|
71862338|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.99|0.19||||||Week 2-HSS0103-Swelling At It's Worst||0.19|-0.99|
71862339|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.446|||TWO_SIDED|90.0|-0.58|0.9||||||Week 4-HSS0103-Swelling At It's Worst||0.90|-0.58|
71862340|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.424|||TWO_SIDED|90.0|-0.87|0.53||||||Week 4-HSS0103-Swelling At It's Worst||0.53|-0.87|
71862341|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.443|||TWO_SIDED|90.0|-0.65|0.82||||||Week 4-HSS0103-Swelling At It's Worst||0.82|-0.65|
71862342|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.7|STANDARD_ERROR_OF_MEAN|0.51|||TWO_SIDED|90.0|-0.15|1.54||||||Week 6-HSS0103-Swelling At It's Worst||1.54|-0.15|
71862343|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.493|||TWO_SIDED|90.0|-0.83|0.8||||||Week 6-HSS0103-Swelling At It's Worst||0.80|-0.83|
71862344|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.513|||TWO_SIDED|90.0|-0.62|1.08||||||Week 6-HSS0103-Swelling At It's Worst||1.08|-0.62|
71862345|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.29|STANDARD_ERROR_OF_MEAN|0.507|||TWO_SIDED|90.0|-0.55|1.13||||||Week 8-HSS0103-Swelling At It's Worst||1.13|-0.55|
71862346|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.489|||TWO_SIDED|90.0|-0.81|0.81||||||Week 8-HSS0103-Swelling At It's Worst||0.81|-0.81|
71862347|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.514|||TWO_SIDED|90.0|-0.35|1.35||||||Week 8-HSS0103-Swelling At It's Worst||1.35|-0.35|
71862348|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.07|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-0.81|0.95||||||Week 12-HSS0103-Swelling At It's Worst||0.95|-0.81|
71862349|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.47|STANDARD_ERROR_OF_MEAN|0.505|||TWO_SIDED|90.0|-1.3|0.37||||||Week 12-HSS0103-Swelling At It's Worst||0.37|-1.30|
71862350|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.04|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-0.92|0.84||||||Week 12-HSS0103-Swelling At It's Worst||0.84|-0.92|
71862351|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.589|||TWO_SIDED|90.0|-0.75|1.2||||||Week 16-HSS0103-Swelling At It's Worst||1.20|-0.75|
71862352|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-1.06|STANDARD_ERROR_OF_MEAN|0.561|||TWO_SIDED|90.0|-1.99|-0.13||||||Week 16-HSS0103-Swelling At It's Worst||-0.13|-1.99|
71862353|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-1.02|STANDARD_ERROR_OF_MEAN|0.586|||TWO_SIDED|90.0|-1.99|-0.05||||||Week 16-HSS0103-Swelling At It's Worst||-0.05|-1.99|
71862354|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.16|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.27|0.59||||||Week 1-HSS0104-Tiredness At It's Worst||0.59|-0.27|
71862355|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.57|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|90.0|-0.99|-0.15||||||Week 1-HSS0104-Tiredness At It's Worst||-0.15|-0.99|
71862356|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.262|||TWO_SIDED|90.0|-0.35|0.52||||||Week 1-HSS0104-Tiredness At It's Worst||0.52|-0.35|
71862357|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.06|STANDARD_ERROR_OF_MEAN|0.357|||TWO_SIDED|90.0|-0.54|0.65||||||Week 2-HSS0104-Tiredness At It's Worst||0.65|-0.54|
71862358|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.44|STANDARD_ERROR_OF_MEAN|0.344|||TWO_SIDED|90.0|-1.01|0.13||||||Week 2-HSS0104-Tiredness At It's Worst||0.13|-1.01|
71862359|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.26|STANDARD_ERROR_OF_MEAN|0.356|||TWO_SIDED|90.0|-0.33|0.85||||||Week 2-HSS0104-Tiredness At It's Worst||0.85|-0.33|
71862360|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.12|STANDARD_ERROR_OF_MEAN|0.434|||TWO_SIDED|90.0|-0.83|0.6||||||Week 4-HSS0104-Tiredness At It's Worst||0.60|-0.83|
71862361|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.414|||TWO_SIDED|90.0|-1.49|-0.12||||||Week 4-HSS0104-Tiredness At It's Worst||-0.12|-1.49|
71862362|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.14|STANDARD_ERROR_OF_MEAN|0.431|||TWO_SIDED|90.0|-0.86|0.57||||||Week 4-HSS0104-Tiredness At It's Worst||0.57|-0.86|
71862363|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.04|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.76|0.84||||||Week 6-HSS0104-Tiredness At It's Worst||0.84|-0.76|
71862364|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.52|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.29|0.26||||||Week 6-HSS0104-Tiredness At It's Worst||0.26|-1.29|
71862365|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.485|||TWO_SIDED|90.0|-0.68|0.92||||||Week 6-HSS0104-Tiredness At It's Worst||0.92|-0.68|
71908159|NCT02702011|143338842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|65.1|STANDARD_ERROR_OF_MEAN|10.81|<|0.0001|TWO_SIDED|95.0|43.29|86.9|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 2.5 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||86.90|43.29|<0.0001
71922079|NCT03091920|143364994|OTHER|No statistical testing was performed.|Least squares mean difference|-7.06|STANDARD_ERROR_OF_MEAN|3.6|||TWO_SIDED|95.0|-14.52|0.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.40|-14.52|
71862366|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.17|STANDARD_ERROR_OF_MEAN|0.483|||TWO_SIDED|90.0|-0.96|0.63||||||Week 8-HSS0104-Tiredness At It's Worst||0.63|-0.96|
71862367|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.53|STANDARD_ERROR_OF_MEAN|0.466|||TWO_SIDED|90.0|-1.31|0.24||||||Week 8-HSS0104-Tiredness At It's Worst||0.24|-1.31|
71862368|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.11|STANDARD_ERROR_OF_MEAN|0.488|||TWO_SIDED|90.0|-0.69|0.92||||||Week 8-HSS0104-Tiredness At It's Worst||0.92|-0.69|
71862369|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.34|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-1.21|0.53||||||Week 12-HSS0104-Tiredness At It's Worst||0.53|-1.21|
71862370|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.81|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-1.64|0.02||||||Week 12-HSS0104-Tiredness At It's Worst||0.02|-1.64|
71862371|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.15|STANDARD_ERROR_OF_MEAN|0.527|||TWO_SIDED|90.0|-0.72|1.02||||||Week 12-HSS0104-Tiredness At It's Worst||1.02|-0.72|
71862372|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.22|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-0.7|1.15||||||Week 16-HSS0104-Tiredness At It's Worst||1.15|-0.70|
71862373|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.56|STANDARD_ERROR_OF_MEAN|0.532|||TWO_SIDED|90.0|-1.44|0.32||||||Week 16-HSS0104-Tiredness At It's Worst||0.32|-1.44|
71862374|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.557|||TWO_SIDED|90.0|-0.83|1.01||||||Week 16-HSS0104-Tiredness At It's Worst||1.01|-0.83|
71862375|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.264|||TWO_SIDED|90.0|-0.39|0.49||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.49|-0.39|
71862376|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.32|STANDARD_ERROR_OF_MEAN|0.257|||TWO_SIDED|90.0|-0.75|0.1||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.10|-0.75|
71862377|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.02|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.46|0.42||||||Week 1-HSS0105-Bothered By Appearance HS Lesion||0.42|-0.46|
71862378|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.65|0.45||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.45|-0.65|
71862379|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|0.321|||TWO_SIDED|90.0|-1.33|-0.27||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||-0.27|-1.33|
71862380|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.36|STANDARD_ERROR_OF_MEAN|0.333|||TWO_SIDED|90.0|-0.91|0.19||||||Week 2-HSS0105-Bothered By Appearance HS Lesion||0.19|-0.91|
71862381|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.36|1.0||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||1.00|-0.36|
71862382|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.94|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|90.0|-1.59|-0.29||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||-0.29|-1.59|
71862383|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.29|STANDARD_ERROR_OF_MEAN|0.411|||TWO_SIDED|90.0|-0.97|0.39||||||Week 4-HSS0105-Bothered By Appearance HS Lesion||0.39|-0.97|
71681641|NCT05175131|142881549|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.0042|TWO_SIDED|95.0|0.3|1.8|||ANCOVA||Mean difference of Mebeverine+Simethicone combination to Mebeverine. Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||1.8|0.3|0.0042
71862384|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.55|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-0.2|1.3||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||1.30|-0.20|
71862385|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.69|STANDARD_ERROR_OF_MEAN|0.439|||TWO_SIDED|90.0|-1.41|0.04||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.04|-1.41|
71862386|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.456|||TWO_SIDED|90.0|-0.85|0.66||||||Week 6-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.85|
71862387|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.15|STANDARD_ERROR_OF_MEAN|0.491|||TWO_SIDED|90.0|-0.96|0.66||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.66|-0.96|
71862388|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-1.11|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|90.0|-1.89|-0.33||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||-0.33|-1.89|
71862389|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.3|STANDARD_ERROR_OF_MEAN|0.497|||TWO_SIDED|90.0|-1.13|0.52||||||Week 8-HSS0105-Bothered By Appearance HS Lesion||0.52|-1.13|
71862390|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.86|0.95||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||0.95|-0.86|
71908160|NCT02702011|143338842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|81.19|STANDARD_ERROR_OF_MEAN|11.1|<|0.0001|TWO_SIDED|95.0|58.8|103.58|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 10 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||103.58|58.80|<0.0001
71908161|NCT02702011|143338842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|98.11|STANDARD_ERROR_OF_MEAN|11.01|<|0.0001|TWO_SIDED|95.0|75.91|120.31|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 25 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.||120.31|75.91|<0.0001
71908162|NCT01369212|143338852|SUPERIORITY|||||||0.72|||||||Wald test|Proportion with HBsAg loss at week 240 in each group is estimated by Kaplan-Meier and then equality of proportion is tested using Wald test.||||||0.72
71908163|NCT01369212|143338853|SUPERIORITY|||||||0.09||||||The cumulative percentages with HBsAg loss at week 192 were estimated using Kaplan-Meier method and then the equality is tested using Wald test.|Wald Test|||||||0.09
71908164|NCT01369212|143338854|SUPERIORITY|||||||0.46|||||||Fisher Exact|||||||0.46
71908165|NCT01369212|143338855|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71908166|NCT01369212|143338856|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71908167|NCT01369212|143338857|SUPERIORITY|||||||0.039|||||||Fisher Exact|||||||0.039
71908168|NCT01369212|143338858|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71908169|NCT01369212|143338859|SUPERIORITY|||||||0.44|||||||Fisher Exact|||||||0.44
71908170|NCT01369212|143338860|SUPERIORITY|||||||0.06|||||||Fisher Exact|||||||0.06
71908171|NCT01369212|143338861|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
71908172|NCT01369212|143338862|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
71908173|NCT01369212|143338863|SUPERIORITY|||||||0.55|||||||Fisher Exact|||||||0.55
71908174|NCT01369212|143338864|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71908175|NCT01369212|143338865|SUPERIORITY|||||||0.87|||||||Fisher Exact|||||||0.87
71862391|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.87|STANDARD_ERROR_OF_MEAN|0.523|||TWO_SIDED|90.0|-1.73|-0.01||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||-0.01|-1.73|
71862392|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.547|||TWO_SIDED|90.0|-0.78|1.03||||||Week 12-HSS0105-Bothered By Appearance HS Lesion||1.03|-0.78|
71862393|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.602|||TWO_SIDED|90.0|-0.6|1.39||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||1.39|-0.60|
71862394|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.95|STANDARD_ERROR_OF_MEAN|0.574|||TWO_SIDED|90.0|-1.9|0.0||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.00|-1.90|
71862395|NCT04092452|143239574|SUPERIORITY||Risk Difference (RD)|-0.01|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-1.0|0.99||||||Week 16-HSS0105-Bothered By Appearance HS Lesion||0.99|-1.00|
71862396|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
71862397|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
71862398|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
71862399|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
71862400|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
71908176|NCT01369212|143338866|SUPERIORITY|||||||0.02|||||||Fisher Exact|||||||0.02
71908177|NCT01369212|143338867|SUPERIORITY|||||||0.66|||||||Fisher Exact|||||||0.66
71908178|NCT01369212|143338869|SUPERIORITY|||||||0.66|||||||Log Rank|||||||0.66
71908179|NCT01369212|143338870|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
71922080|NCT03091920|143364994|OTHER|No statistical testing was performed.|Least squares mean difference|-4.19|STANDARD_ERROR_OF_MEAN|3.54|||TWO_SIDED|95.0|-11.52|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.14|-11.52|
71688750|NCT03951753|142892918|OTHER||Least Squares Mean Difference|279.14|STANDARD_ERROR_OF_MEAN|17.366|<|0.001|TWO_SIDED|95.0|245.1|313.18|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||313.18|245.10|<0.001
71862401|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
71862402|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
71862403|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
71862404|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
71862405|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
71862406|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
71862407|NCT04092452|143239575|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
71862408|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-1.7|2.6||||||Week 4||2.6|-1.7|
71862409|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-2.7|1.7||||||Week 4||1.7|-2.7|
71862410|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|0.9|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.4|3.2||||||Week 4||3.2|-1.4|
71862411|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-0.5|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-2.7|1.6||||||Week 8||1.6|-2.7|
71862412|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-1.1|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-3.3|1.0||||||Week 8||1.0|-3.3|
71862413|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|1.34|||TWO_SIDED|90.0|-2.2|2.2||||||Week 8||2.2|-2.2|
71862414|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-0.8|STANDARD_ERROR_OF_MEAN|1.44|||TWO_SIDED|90.0|-3.2|1.6||||||Week 12||1.6|-3.2|
71862415|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-2.0|STANDARD_ERROR_OF_MEAN|1.39|||TWO_SIDED|90.0|-4.3|0.3||||||Week 12||0.3|-4.3|
71862416|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-2.6|2.2||||||Week 12||2.2|-2.6|
71862417|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|1.7|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.7|4.2||||||Week 16||4.2|-0.7|
71862418|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-3.6|1.2||||||Week 16||1.2|-3.6|
71862419|NCT04092452|143239576|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.4|2.6||||||Week 16||2.6|-2.4|
71862420|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-9.1|9.5||||||Week 4||9.5|-9.1|
71862421|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|5.25|||TWO_SIDED|90.0|-7.4|9.8||||||Week 4||9.8|-7.4|
71862422|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|-4.0|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|90.0|-11.4|3.4||||||Week 4||3.4|-11.4|
71862423|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|4.3|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|90.0|-3.3|11.8||||||Week 8||11.8|-3.3|
71862424|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|6.2|STANDARD_ERROR_OF_MEAN|4.87|||TWO_SIDED|90.0|-1.8|14.2||||||Week 8||14.2|-1.8|
71862425|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|2.5|STANDARD_DEVIATION|4.42|||TWO_SIDED|90.0|-4.8|9.8||||||Week 8||9.8|-4.8|
71862426|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.43|||TWO_SIDED|90.0|-1.3|16.5||||||Week 12||16.5|-1.3|
71862427|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|6.9|STANDARD_ERROR_OF_MEAN|5.4|||TWO_SIDED|90.0|-2.0|15.7||||||Week 12||15.7|-2.0|
71862428|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|2.9|STANDARD_ERROR_OF_MEAN|5.09|||TWO_SIDED|90.0|-5.5|11.3||||||Week 12||11.3|-5.5|
71862429|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|3.88|||TWO_SIDED|90.0|-6.3|6.4||||||Week 16||6.4|-6.3|
71862430|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|6.5|STANDARD_ERROR_OF_MEAN|5.63|||TWO_SIDED|90.0|-2.8|15.7||||||Week 16||15.7|-2.8|
71862431|NCT04092452|143239577|SUPERIORITY||Risk Difference (RD)|7.6|STANDARD_ERROR_OF_MEAN|5.64|||TWO_SIDED|90.0|-1.6|16.9||||||Week 16||16.9|-1.6|
71862432|NCT02127125|143239579|SUPERIORITY||||||<|0.025||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||<0.025
71862433|NCT02127125|143239579|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
71862434|NCT02127125|143239580|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
71862435|NCT02127125|143239580|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in insulin sensitivity compared to placebo treated subjects.||||>0.05
71862436|NCT02127125|143239581|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Sevelamer treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
71908180|NCT00862121|143338871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.212||||0.231|TWO_SIDED|95.0|0.017|2.683|||Regression, Logistic|||The odds ratio (OR) for Baseline CDAI measures the effect of an increase of one unit on the outcome. The OR \[95% CI\] and p-value (likelihood-based) are for Pentasa versus placebo estimated in a logistic regression analysis including TREATMENT and CDAI at baseline as covariates. Power to demonstrate superiority of PENTASA Sachet 6 g/day over placebo in the primary efficacy analysis was 90% for a planned sample size of 255 participants per treatment arm (assuming 10% nonassessable participants).||2.683|0.017|0.231
71908181|NCT00475540|143338886|SUPERIORITY|Statistical analysis was performed using SAS 9.1 software. One patient did not receive the assigned mesh treatment because the surgeon felt there was inadequate vaginal caliber, so non mesh repair was performed. This subject was analyzed in the non mesh group for the 3-month and 1-year outcomes rather than intent-to-treat approach. This subject was lost to follow-up after 12 months and not included in the 3-year analysis.|||||<|0.05|||||||t-test, 2 sided|t-tests, Wilcoxon signed rank, Wilcoxon rank-sum tests continuous variables; X2 for categorical variables. Combined cure outcomes Fisher's exact test||Sample size primary outcome 1 year: 45 participants per arm, 20% difference success (70% no mesh and 90% mesh), alpha of .05 and 80% power, 15% loss to follow-up.||||<0.05
71908182|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0507|STANDARD_ERROR_OF_MEAN|0.0339|||ONE_SIDED|90.0|0.0059||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90 percent (%) confidence interval (CI) was reported.|||0.0059|
71908183|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0788|STANDARD_ERROR_OF_MEAN|0.027|||ONE_SIDED|90.0|0.0431||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0431|
71908184|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0927|STANDARD_ERROR_OF_MEAN|0.0277|||ONE_SIDED|90.0|0.056||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0560|
71908185|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0613|STANDARD_ERROR_OF_MEAN|0.03|||ONE_SIDED|90.0|0.0215||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|||0.0215|
71908186|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0105|STANDARD_ERROR_OF_MEAN|0.0309|||ONE_SIDED|80.0|-0.0371||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0371|
71908187|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0175|STANDARD_ERROR_OF_MEAN|0.0246|||ONE_SIDED|80.0|-0.0037||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||-0.0037|
71908188|NCT01033487|143338898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0315|STANDARD_ERROR_OF_MEAN|0.0294|||ONE_SIDED|80.0|0.0062||||Emax Model|||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|||0.0062|
71908189|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0989|STANDARD_ERROR_OF_MEAN|0.242|||ONE_SIDED|90.0|0.0676||||ANOVA|||Mixed effects analysis of variance (ANOVA) was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0676|
71908190|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1748|STANDARD_ERROR_OF_MEAN|0.0245|||ONE_SIDED|90.0|0.1431||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1431|
71862437|NCT02127125|143239581|SUPERIORITY||||||>|0.05||||||p-value not adjusted for multiple comparison, a priori threshold for significance set at p\<0.025 for multiple comparisons.|Generalized Estimating Equation|||Null hypothesis is that Synbiotic treated Obese subjects with normal glucose tolerance will show no post-treatment change in Lactulose:Mannitol ratio compared to placebo treated subjects.||||>0.05
71862438|NCT00855413|143239616|OTHER|one sided ANOVA.|Mean Difference (Final Values)|4.23|STANDARD_DEVIATION|0.15||0.03|TWO_SIDED|||||The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.|ANOVA|||An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.||||0.03
71862439|NCT00855413|143239618|OTHER|Spearman correlation|spearman correlation|-0.82|||<|0.005|TWO_SIDED|||||R = -0.82|Spearman correlation|||Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|Correlation between time (days) to HIV RNA suppression \<200 copies/mL and total z score (mean) was assessed by Spearman correlation|||<.005
71862440|NCT00848484|143239629|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.277
71862441|NCT00848484|143239630|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
71862442|NCT00848484|143239631|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.933
71862443|NCT00848484|143239632|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
71862444|NCT00848484|143239633|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|Wilcoxon (Mann-Whitney)|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
71862445|NCT00848484|143239634|SUPERIORITY_OR_OTHER|||||||0.686||95.0||||The Benjamini \& Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence \* time with a restriction of the same baseline mean across treatment sequences.||||||0.686
71862446|NCT03355209|143239639|SUPERIORITY||Median Difference (A-P)|-19.88||||0.0008|TWO_SIDED|95.0|-31.02|-8.74|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||-8.74|-31.02|0.0008
71862447|NCT03355209|143239642|SUPERIORITY||Median Difference (A-P)|-10.5||||0.146|TWO_SIDED|95.0|-24.99|3.99|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann (HL) method|||3.99|-24.99|0.1460
71862448|NCT03355209|143239643|SUPERIORITY||Odds Ratio (OR)|3.3||||0.0051|TWO_SIDED|95.0|1.43|7.59|||Regression, Logistic|||||7.59|1.43|0.0051
71862449|NCT03355209|143239643|SUPERIORITY||Odds Ratio (OR)|2.87||||0.015|TWO_SIDED|95.0|1.23|6.7|||Regression, Logistic|||||6.70|1.23|0.0150
71862450|NCT03355209|143239644|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1565|TWO_SIDED|95.0|0.84|2.97|||Cochran-Mantel-Haenszel|||Visit 12||2.97|0.84|0.1565
71862451|NCT03355209|143239644|SUPERIORITY||Odds Ratio (OR)|1.86||||0.0567|TWO_SIDED|95.0|0.98|3.52|||Cochran-Mantel-Haenszel|||Visit 12||3.52|0.98|0.0567
71862452|NCT02097303|143239689|OTHER||||||<|1e-05||||||Comparison of ALP levels before and after treatment|t-test, 2 sided|||||||<.00001
71862453|NCT02097303|143239689|OTHER|||||||0.487||||||Comparison of PSA levels before and after treatment|t-test, 2 sided|||||||0.4870
71862454|NCT02975102|143239708|NON_INFERIORITY|A sample size of 33 evaluable patients per treatment group was calculated to provide at least 90% power to demonstrate non-inferiority of CBL-101 to Vismed Multi. Assumptions included a non-inferiority margin of 2 grades and a standard deviation of 2.5|Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-1.2|0.3|||||Treatment difference : CBL-101 - Vismed Multi|||0.3|-1.2|
71862455|NCT02975102|143239709|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71862456|NCT02975102|143239710|SUPERIORITY|||||||0.0002||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0002
71862457|NCT02975102|143239711|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71862458|NCT02975102|143239712|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71862459|NCT02975102|143239713|SUPERIORITY|||||||0.0186||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0186
71681642|NCT05175131|142881549|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.0001|TWO_SIDED|95.0|0.9|2.4|||ANCOVA||Adjusted least squares mean (difference between Mebeverine+Simethicone combination and Mebeverine) from ANCOVA is presented here|Mean difference of Mebeverine+Simethicone combination to Simethicone. ANCOVA was used for primary end point analysis. The model included the change from baseline of the NRS\_11 score as dependent variable and treatment and site as independent factors, and baseline NRS-11 as covariate.||2.4|0.9|<0.0001
71681643|NCT00310466|142881556|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||ANOVA|||||||0.87
71681644|NCT00310466|142881557|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||||||0.04
71681645|NCT00310466|142881559|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||ANOVA|||||||0.55
71681646|NCT00585013|142881560|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This p value applies to all time points for all variables.|Wilcoxon (Mann-Whitney)|||||||>0.05
71681647|NCT00585013|142881561|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies for measurements at preoperative and 0 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
71862460|NCT02975102|143239714|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71908191|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1909|STANDARD_ERROR_OF_MEAN|0.0243|||ONE_SIDED|90.0|0.1594||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1594|
71908192|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1528|STANDARD_ERROR_OF_MEAN|0.0237|||ONE_SIDED|90.0|0.1222||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1222|
71908193|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0539|STANDARD_ERROR_OF_MEAN|0.0239|||ONE_SIDED|90.0|-0.0849||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0849|
71908194|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_DEVIATION|0.0238|||ONE_SIDED|90.0|-0.0088||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0088|
71908195|NCT01033487|143338907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0381|STANDARD_ERROR_OF_MEAN|0.0242|||ONE_SIDED|90.0|0.0068||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0068|
71908196|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0852|STANDARD_ERROR_OF_MEAN|0.0214|||ONE_SIDED|90.0|0.0576||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.0576|
71908197|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1418|STANDARD_ERROR_OF_MEAN|0.0219|||ONE_SIDED|90.0|0.1136||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1136|
71908198|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1692|STANDARD_ERROR_OF_MEAN|0.0216|||ONE_SIDED|90.0|0.1413||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1413|
71862461|NCT02975102|143239715|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71862462|NCT02975102|143239716|SUPERIORITY|||||||0.0011||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0011
71862463|NCT02975102|143239717|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71908199|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1526|STANDARD_ERROR_OF_MEAN|0.0212|||ONE_SIDED|90.0|0.1252||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||0.1252|
71908200|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0674|STANDARD_ERROR_OF_MEAN|0.0211|||ONE_SIDED|90.0|-0.0946||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0946|
71862464|NCT02975102|143239718|SUPERIORITY||||||>|0.05||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||> 0.05
71862465|NCT02975102|143239719|SUPERIORITY|||||||0.005||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.005
71862466|NCT02975102|143239720|SUPERIORITY|||||||0.0008||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0008
71681648|NCT00585013|142881561|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to measurements at time points 12 h, 24 h, and 48 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
71862467|NCT02975102|143239721|SUPERIORITY|||||||0.0026||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0026
71862468|NCT02975102|143239722|SUPERIORITY|||||||0.077||||||Significance level of 0.05 . P-Value result provided only for Global Question|ANCOVA|Adjustment for baseline||||||0.077
71862469|NCT02975102|143239723|SUPERIORITY|||||||0.6097||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.6097
71862470|NCT02975102|143239724|SUPERIORITY|||||||0.231||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.231
71862471|NCT02975102|143239725|SUPERIORITY|||||||0.0135||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.0135
71862472|NCT02975102|143239726|SUPERIORITY|||||||0.575||||||Significance level of 0.05|ANCOVA|Adjustment for baseline||||||0.575
71862473|NCT04069585|143239727|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0002||||||One-sided paired t-test|t-test, 1 sided|||||||<0.0002
71862474|NCT01441635|143239743|SUPERIORITY||LS Mean Difference|-205.9|STANDARD_ERROR_OF_MEAN|45.1|<|0.001|TWO_SIDED|95.0|-295.77|-116.01|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-116.01|-295.77|< 0.001
71862475|NCT01441635|143239743|SUPERIORITY||LS Mean Difference|-189.9|STANDARD_ERROR_OF_MEAN|44.36|<|0.001|TWO_SIDED|95.0|-278.33|-101.53|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-101.53|-278.33|< 0.001
71862476|NCT01441635|143239743|SUPERIORITY||LS Mean Difference|-138.0|STANDARD_ERROR_OF_MEAN|40.86||0.001|TWO_SIDED|95.0|-220.18|-55.76|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-55.76|-220.18|0.001
71862477|NCT01441635|143239743|SUPERIORITY||LS Mean Difference|-130.6|STANDARD_ERROR_OF_MEAN|37.68||0.001|TWO_SIDED|95.0|-206.7|-54.6|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-54.60|-206.70|0.001
71862478|NCT01441635|143239744|SUPERIORITY||LS Mean Difference|-75.6|STANDARD_ERROR_OF_MEAN|13.71|<|0.001|TWO_SIDED|95.0|-102.93|-48.28|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-48.28|-102.93|< 0.001
71862479|NCT01441635|143239744|SUPERIORITY||LS Mean Difference|-64.27|STANDARD_ERROR_OF_MEAN|13.48|<|0.001|TWO_SIDED|95.0|-91.14|-37.39|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-37.39|-91.14|< 0.001
71681649|NCT00585013|142881562|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||This applies to measurements at preoperative, 0 h, and 48 h time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
71908201|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0108|STANDARD_ERROR_OF_MEAN|0.0213|||ONE_SIDED|90.0|-0.0383||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0383|
71908202|NCT01033487|143338908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0166|STANDARD_ERROR_OF_MEAN|0.213|||ONE_SIDED|90.0|-0.011||||ANOVA|||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|||-0.0110|
71908203|NCT03788967|143338958|NON_INFERIORITY|The non-inferiority hypothesis test was a 1-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in overall response was greater than -12.5%, non-inferiority was declared.|Risk Difference|-3.3|||||TWO_SIDED|95.0|-9.7|3.2||||||||3.2|-9.7|
71908204|NCT03788967|143338960|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-11.3|1.9||||||||1.9|-11.3|
71908205|NCT03788967|143338961|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-0.1|3.4||||||Statistical Analysis 1 (EOT)||3.4|-0.1|
71908206|NCT03788967|143338961|OTHER||Risk Difference|-0.6|||||TWO_SIDED|95.0|-4.0|2.8||||||Statistical Analysis 2 (TOC)||2.8|-4|
71908207|NCT03788967|143338961|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-5.7|2.6||||||Statistical Analysis 3 (LFU)||2.6|-5.7|
71908208|NCT03788967|143338962|OTHER||Risk Difference|0.7|||||TWO_SIDED|95.0|-0.3|2.0||||||||2.0|-0.3|
71908209|NCT03788967|143338963|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-3.8|0.6||||||||0.6|-3.8|
71908210|NCT03788967|143338964|OTHER||Risk Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.3||||||||2.3|-3.3|
71908211|NCT03788967|143338965|OTHER||Risk Difference|1.3|||||TWO_SIDED|95.0|-0.2|3.2||||||||3.2|-0.2|
71908212|NCT03788967|143338966|OTHER||Risk Difference|-2.2|||||TWO_SIDED|95.0|-5.3|0.8||||||||0.8|-5.3|
71908213|NCT03788967|143338967|OTHER||Risk Difference|-1.2|||||TWO_SIDED|95.0|-5.1|2.6||||||||2.6|-5.1|
71908214|NCT03788967|143338968|OTHER||Risk Difference|1.5|||||TWO_SIDED|95.0|-0.8|4.1||||||Statistical Analysis 1 (EOT)||4.1|-0.8|
71908215|NCT03788967|143338968|OTHER||Risk Difference|-4.5|||||TWO_SIDED|95.0|-10.8|1.9||||||Statistical Analysis 2 (TOC)||1.9|-10.8|
71908216|NCT03788967|143338968|OTHER||Risk Difference|-1.5|||||TWO_SIDED|95.0|-7.9|5.0||||||||5|-7.9|
71908217|NCT03788967|143338972|OTHER||Risk Difference|-0.2|||||TWO_SIDED|95.0|-1.6|1.2||||||||1.2|-1.6|
71908218|NCT03788967|143338973|OTHER||Risk Difference|-5.9|||||TWO_SIDED|95.0|-12.4|0.7||||||||0.7|-12.4|
71908219|NCT03788967|143338974|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-8.5|5.3||||||||5.3|-8.5|
71908220|NCT03788967|143338978|OTHER||Risk Difference|-4.7|||||TWO_SIDED|95.0|-13.5|4.1||||||Overall response for participants with AP||4.1|-13.5|
71908221|NCT03788967|143338978|OTHER||Risk Difference|-1.6|||||TWO_SIDED|95.0|-11.0|7.7||||||Overall response in participants with cUTI||7.7|-11.0|
71908222|NCT03788967|143338979|OTHER||Risk Difference|1.4|||||TWO_SIDED|95.0|-7.2|9.9||||||||9.9|-7.2|
71908223|NCT03788967|143338979|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-20.6|3.8||||||≥65 to \<75 years||3.8|-20.6|
71908224|NCT03788967|143338979|OTHER||Risk Difference (RD)|-7.5|||||TWO_SIDED|95.0|-23.8|8.7||||||≥75 years||8.7|-23.8|
71908225|NCT03788967|143338980|OTHER||Risk Difference|-3.1|||||TWO_SIDED|95.0|-9.6|3.5||||||Central and Eastern Europe||3.5|-9.6|
71908226|NCT03788967|143338981|OTHER|||||||0.044|||||||Log Rank|||||||0.044
71681650|NCT00585013|142881562|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This applies to time points at 12 h and 24 h.|Wilcoxon (Mann-Whitney)|||||||<0.05
71681651|NCT00585013|142881563|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||Applies to all time points.|Wilcoxon (Mann-Whitney)|||||||>0.05
71681652|NCT03747302|142881565|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||||||.003
71908227|NCT03788967|143338982|OTHER|||||||0.736|||||||Log Rank|||||||0.736
71908228|NCT04847141|143338996|SUPERIORITY||Difference in Percentage|-3.6||||0.5167|TWO_SIDED|95.0|-14.6|7.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 1 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||7.4|-14.6|0.5167
71908229|NCT04847141|143338996|SUPERIORITY||Difference in Percentage|1.2||||0.8197|TWO_SIDED|95.0|-9.6|12.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants meeting the primary efficacy endpoint between C19-IG 20% 2 g and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||12.0|-9.6|0.8197
71908230|NCT04847141|143338997|SUPERIORITY||Least squares (LS) Mean Difference|0.1||||0.5756|TWO_SIDED|95.0|-0.24|0.44|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.44|-0.24|0.5756
71908231|NCT04847141|143338997|SUPERIORITY||LS Mean Difference|-0.17||||0.3289|TWO_SIDED|95.0|-0.52|0.17|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 7||0.17|-0.52|0.3289
71908232|NCT04847141|143338997|SUPERIORITY||LS Mean Difference|0.11||||0.3418|TWO_SIDED|95.0|-0.12|0.34|||ANCOVA||95% CI for the difference in LS Mean between 1 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.34|-0.12|0.3418
71908233|NCT04847141|143338997|SUPERIORITY||LS Mean Difference|-0.11||||0.3688|TWO_SIDED|95.0|-0.34|0.13|||ANCOVA||95% CI for the difference in LS Mean between 2 g C19-IG 20% dose group \& placebo was calculated using ANCOVA model, including CFB value as dependent variable; treatment group as fixed effect; \& baseline viral load value, age, \& gender as covariates.|Day 14||0.13|-0.34|0.3688
71908234|NCT04847141|143338998|SUPERIORITY||Difference in Percentage|-1.3||||0.1506|TWO_SIDED|95.0|-4.7|1.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||1.2|-4.7|0.1506
71908235|NCT04847141|143338998|SUPERIORITY||Difference in Percentage|1.3||||0.1655|TWO_SIDED|95.0|-1.3|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||4.6|-1.3|0.1655
71908236|NCT04847141|143338998|SUPERIORITY||Difference in Percentage|-2.0||||0.2337|TWO_SIDED|95.0|-6.5|1.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||1.7|-6.5|0.2337
71908237|NCT04847141|143338998|SUPERIORITY||Difference in Percentage|-0.8||||0.7212|TWO_SIDED|95.0|-6.1|4.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 1 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||4.2|-6.1|0.7212
71908238|NCT04847141|143338998|SUPERIORITY||Difference in Percentage|-2.1||||0.3897|TWO_SIDED|95.0|-7.8|3.1||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who remained in an outpatient setting \& maintained SpO2≥94% between C19-IG 20% 2 g \& placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||3.1|-7.8|0.3897
71908239|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|3.1||||0.5489|TWO_SIDED|95.0|-7.1|13.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 3||13.3|-7.1|0.5489
71908240|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|4.4||||0.392|TWO_SIDED|95.0|-5.8|14.7||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 3||14.7|-5.8|0.3920
71908241|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|1.7||||0.7632|TWO_SIDED|95.0|-9.5|12.9||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 7||12.9|-9.5|0.7632
71908242|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|7.9||||0.1702|TWO_SIDED|95.0|-3.6|19.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 7||19.2|-3.6|0.1702
71908243|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|-2.0||||0.7316|TWO_SIDED|95.0|-13.3|9.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 14||9.4|-13.3|0.7316
71908244|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|6.9||||0.2104|TWO_SIDED|95.0|-4.2|18.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 14||18.0|-4.2|0.2104
71908245|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|4.9||||0.2059|TWO_SIDED|95.0|-2.9|13.2||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|Day 29||13.2|-2.9|0.2059
71681653|NCT03747302|142881566|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||Change in mean scores for behavioral intent to vaccine: negative values: smaller values indicate more likely to vaccinate.||||>.05
71908246|NCT04847141|143338999|SUPERIORITY||Difference in Percentage|1.9||||0.6463|TWO_SIDED|95.0|-6.5|10.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who had a negative test result between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|Day 29||10.3|-6.5|0.6463
71908247|NCT04847141|143339000|SUPERIORITY|||||||0.9033|||||||Log Rank|||||||0.9033
71908248|NCT04847141|143339000|SUPERIORITY|||||||0.5456|||||||Log Rank|||||||0.5456
71908249|NCT04847141|143339001|SUPERIORITY||Difference in Percentage|0.79||||0.6311|TWO_SIDED|95.0|-2.9|4.6||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 1 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||4.6|-2.9|0.6311
71908250|NCT04847141|143339001|SUPERIORITY||Difference in Percentage|2.6||||0.1441|TWO_SIDED|95.0|-1.2|7.3||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required oxygen supplementation between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between each of 2 g C19-IG 20% dose group and placebo was calculated using the exact unconditional method.|||7.3|-1.2|0.1441
71908251|NCT04847141|143339002|SUPERIORITY||LS Mean (LSM) Difference|0.02||||0.8555|TWO_SIDED|95.0|-0.23|0.27|||ANCOVA||95% CI for difference in LSM between 1 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.27|-0.23|0.8555
71908252|NCT04847141|143339002|SUPERIORITY||LS Mean Difference|0.03||||0.8108|TWO_SIDED|95.0|-0.22|0.28|||ANCOVA||95% CI for difference in LSM between 2 g C19-IG 20% \& placebo was calculated using an ANCOVA model,with number of days on oxygen as dependent variable \& treatment group as fixed effect,adjusting for baseline characteristics(including age \& gender).|||0.28|-0.22|0.8108
71908253|NCT04847141|143339004|SUPERIORITY||LS Mean Difference|0.03||||0.0692|TWO_SIDED|95.0|0.0|0.07||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.07|-0.00|0.0692
71908254|NCT04847141|143339004|SUPERIORITY||LS Mean Difference|0.01||||0.4956|TWO_SIDED|95.0|-0.02|0.05||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.05|-0.02|0.4956
71908255|NCT04847141|143339004|SUPERIORITY||LS Mean Difference|-0.05||||0.22|TWO_SIDED|95.0|-0.13|0.03||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.03|-0.13|0.2200
71908256|NCT04847141|143339004|SUPERIORITY||LS Mean Difference|-0.07||||0.0906|TWO_SIDED|95.0|-0.14|0.01||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.01|-0.14|0.0906
71908257|NCT04847141|143339004|SUPERIORITY||LS Mean Difference|-0.04||||0.0439|TWO_SIDED|95.0|-0.07|0.0||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||-0.00|-0.07|0.0439
71908258|NCT04847141|143339004|SUPERIORITY||LS Mean Difference|-0.01||||0.4128|TWO_SIDED|95.0|-0.05|0.02||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.02|-0.05|0.4128
71908259|NCT04847141|143339006|SUPERIORITY||LS Mean Difference|-0.01||||0.9713|TWO_SIDED|95.0|-0.28|0.27||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.27|-0.28|0.9713
71681654|NCT02635542|142881582|SUPERIORITY|||||||1|||||||Chi-squared|||||||1.00
71908260|NCT04847141|143339006|SUPERIORITY||LS Mean Difference|0.07||||0.5985|TWO_SIDED|95.0|-0.2|0.35||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 7||0.35|-0.20|0.5985
71908261|NCT04847141|143339006|SUPERIORITY||LS Mean Difference|0.01||||0.9209|TWO_SIDED|95.0|-0.25|0.28||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.28|-0.25|0.9209
71908262|NCT04847141|143339006|SUPERIORITY||LS Mean Difference|-0.01||||0.9181|TWO_SIDED|95.0|-0.28|0.25||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 14||0.25|-0.28|0.9181
71908263|NCT04847141|143339006|SUPERIORITY||LS Mean Difference|0.15||||0.2443|TWO_SIDED|95.0|-0.11|0.41||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.41|-0.11|0.2443
71862480|NCT01441635|143239744|SUPERIORITY||LS Mean Difference|-67.67|STANDARD_ERROR_OF_MEAN|22.73||0.005|TWO_SIDED|95.0|-113.39|-21.96|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-21.96|-113.39|0.005
71908264|NCT04847141|143339006|SUPERIORITY||LS Mean Difference|0.13||||0.3233|TWO_SIDED|95.0|-0.13|0.39||p-value was calculated using restricted maximum likelihood with the Kenward-Roger method.|Kenward-Roger||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Day 29||0.39|-0.13|0.3233
71908265|NCT04847141|143339007|SUPERIORITY||Difference in Percentage|3.0||||0.4676|TWO_SIDED|95.0|-5.3|11.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||11.5|-5.3|0.4676
71908266|NCT04847141|143339007|SUPERIORITY||Difference in Percentage|4.9||||0.2507|TWO_SIDED|95.0|-3.6|13.4||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required at least 1 COVID-19 related MAV between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||13.4|-3.6|0.2507
71908267|NCT04847141|143339008|SUPERIORITY||Difference in Percentage|0.1||||0.9744|TWO_SIDED|95.0|-3.8|4.0||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||4.0|-3.8|0.9744
71908268|NCT04847141|143339008|SUPERIORITY||Difference in Percentage|2.7||||0.1878|TWO_SIDED|95.0|-1.6|7.5||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required hospital admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||7.5|-1.6|0.1878
71908269|NCT04847141|143339009|SUPERIORITY||LS Mean Difference|0.01||||0.9485|TWO_SIDED|95.0|-0.38|0.4|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.40|-0.38|0.9485
71908270|NCT04847141|143339009|SUPERIORITY||LS Mean Difference|0.14||||0.4734|TWO_SIDED|95.0|-0.25|0.54|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.54|-0.25|0.4734
71908271|NCT04847141|143339010|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
71908272|NCT04847141|143339010|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants who required ICU admission between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
71681655|NCT02635542|142881583|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71862481|NCT01441635|143239744|SUPERIORITY||LS mean Difference|-56.84|STANDARD_ERROR_OF_MEAN|8.12|<|0.001|TWO_SIDED|95.0|-73.24|-40.45|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-40.45|-73.24|< 0.001
71862482|NCT01441635|143239745|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862483|NCT01441635|143239745|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862484|NCT01441635|143239745|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862485|NCT01441635|143239745|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862486|NCT01441635|143239746|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862487|NCT01441635|143239746|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862488|NCT01441635|143239746|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862489|NCT01441635|143239746|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862490|NCT01441635|143239747|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862491|NCT01441635|143239747|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862492|NCT01441635|143239747|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862493|NCT01441635|143239747|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862494|NCT01441635|143239749|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|0.97|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|0.97|< 0.001
71862495|NCT01441635|143239749|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|1.0|2.56|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||2.56|1.00|< 0.001
71862496|NCT01441635|143239749|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.4||0.024|TWO_SIDED|95.0|0.13|1.75|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.75|0.13|0.024
71862497|NCT01441635|143239749|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|0.3||0.005|TWO_SIDED|95.0|0.28|1.51|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.51|0.28|0.005
71862498|NCT01441635|143239750|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.14||0.011|TWO_SIDED|95.0|-0.63|-0.08|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.08|-0.63|0.011
71681656|NCT01432275|142881593|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Binomial test|Comparison to 27 participants that preferred their usual method to FreeStyle InsuLinx. Twelve(12) participants did not have a preference.||||||<0.0001
71862499|NCT01441635|143239750|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.03|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.03|-0.59|0.030
71862500|NCT01441635|143239750|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.109|TWO_SIDED|95.0|-0.59|0.06|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||0.06|-0.59|0.109
71908273|NCT04847141|143339011|SUPERIORITY||LS Mean Difference|0.03||||0.578|TWO_SIDED|95.0|-0.07|0.12|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 1 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.12|-0.07|0.5780
71681657|NCT01935700|142881613|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in median survival between the colchicine group and the sorafenib treated group.||||||0.4593|||||||Mann-Whitney U test|||||||0.4593
71862501|NCT01441635|143239750|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.002|TWO_SIDED|95.0|-0.8|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-0.80|0.002
71862502|NCT01441635|143239751|SUPERIORITY||LS Mean Difference|-10.29|STANDARD_ERROR_OF_MEAN|4.32||0.02|TWO_SIDED|95.0|-18.9|-1.67|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.67|-18.90|0.020
71862503|NCT01441635|143239751|SUPERIORITY||LS Mean Difference|-7.62|STANDARD_ERROR_OF_MEAN|4.39||0.087|TWO_SIDED|95.0|-16.36|1.13|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.13|-16.36|0.087
71862504|NCT01441635|143239751|SUPERIORITY||LS Mean Difference|-8.81|STANDARD_ERROR_OF_MEAN|4.28||0.045|TWO_SIDED|95.0|-17.43|-0.19|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-0.19|-17.43|0.045
71862505|NCT01441635|143239751|SUPERIORITY||LS Mean Difference|-13.69|STANDARD_ERROR_OF_MEAN|4.14||0.002|TWO_SIDED|95.0|-22.06|-5.32|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-5.32|-22.06|0.002
71862506|NCT01441635|143239752|SUPERIORITY||LS Mean Difference|-5.51|STANDARD_ERROR_OF_MEAN|2.03||0.008|TWO_SIDED|95.0|-9.56|-1.47|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-1.47|-9.56|0.008
71908274|NCT04847141|143339011|SUPERIORITY||LS Mean Difference|0.01||||0.9065|TWO_SIDED|95.0|-0.09|0.1|||ANCOVA||95% CI for difference in LS Mean between C19-IG 20% 2 g dose group and placebo was calculated using ANCOVA model, including length of hospital stay as dependent variable \& treatment group as fixed effect, adjusting for baseline.|||0.10|-0.09|0.9065
71908275|NCT04847141|143339015|SUPERIORITY||Difference in Percentage|0.02||||0.9853|TWO_SIDED|95.0|-3.05|3.12||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 1 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 1 g dose group and placebo was calculated using the exact unconditional method.|||3.12|-3.05|0.9853
71681658|NCT01935700|142881613|NON_INFERIORITY|Non-inferiority was defined as no statistically significant difference (P value \> 0.05) in survival between the colchicine group and the sorafenib treated group.||||||0.329|||||||Log Rank|||||||0.3290
71862507|NCT01441635|143239752|SUPERIORITY||LS Mean Difference|-4.95|STANDARD_ERROR_OF_MEAN|2.08||0.02|TWO_SIDED|95.0|-9.11|-0.8|||ANCOVA|||||-0.80|-9.11|0.020
71862508|NCT01441635|143239752|SUPERIORITY||LS Mean Difference|-3.63|STANDARD_ERROR_OF_MEAN|2.75||0.194|TWO_SIDED|95.0|-9.18|1.91|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||1.91|-9.18|0.194
71862509|NCT01441635|143239752|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.04||0.001|TWO_SIDED|95.0|-11.33|-3.07|||ANCOVA|ANCOVA model with treatment as a factor and baseline as a covariate.||||-3.07|-11.33|0.001
71862510|NCT01441635|143239755|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
71862511|NCT01441635|143239755|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
71862512|NCT01441635|143239755|SUPERIORITY|||||||0.052|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.052
71862513|NCT01441635|143239755|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||< 0.001
71862514|NCT01441635|143239756|SUPERIORITY|||||||0.003|||||||Fisher Exact|||||||0.003
71862515|NCT01441635|143239756|SUPERIORITY|||||||0.016|||||||Fisher Exact|||||||0.016
71862516|NCT01441635|143239756|SUPERIORITY|||||||0.012|||||||Fisher Exact|||||||0.012
71862517|NCT01441635|143239756|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71862518|NCT01441635|143239757|SUPERIORITY|||||||0.161|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor||||||0.161
71862519|NCT01441635|143239757|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.173
71862520|NCT01441635|143239757|SUPERIORITY|||||||0.072|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.072
71862521|NCT01441635|143239757|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|One-way Kruskal-Wallis test with treatment as a factor.||||||0.003
71862522|NCT01441635|143239758|SUPERIORITY|||||||0.203|||||||Fisher Exact|||||||0.203
71862523|NCT01441635|143239758|SUPERIORITY|||||||0.342|||||||Fisher Exact|||||||0.342
71862524|NCT01441635|143239758|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||0.038
71862525|NCT01441635|143239758|SUPERIORITY|||||||0.111|||||||Fisher Exact|||||||0.111
71862526|NCT01825577|143239763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9||||0.55|TWO_SIDED||||||t-test, 2 sided|||||||.55
71862527|NCT01825577|143239764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||.67
71862528|NCT00358644|143239765|SUPERIORITY_OR_OTHER||Percentage of Participants|23.6||||||95.0|13.2|37.0||||||||37.0|13.2|
71862529|NCT03332784|143239799|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
71862530|NCT03332784|143239799|SUPERIORITY||||||<|0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||<0.0001
71862531|NCT03332784|143239799|SUPERIORITY|||||||0.0001||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||||||0.0001
71862532|NCT01055704|143239805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.389||0.902|TWO_SIDED|95.0|-0.835|0.739|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.739|-0.835|0.902
71862533|NCT01055704|143239805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.351||0.709|TWO_SIDED|95.0|-0.578|0.841|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.841|-0.578|0.709
71862534|NCT01055704|143239806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.971|STANDARD_ERROR_OF_MEAN|4.669||0.675|TWO_SIDED|95.0|-11.415|7.472|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||7.472|-11.415|0.675
71862535|NCT01055704|143239806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.28|STANDARD_ERROR_OF_MEAN|4.208||0.591|TWO_SIDED|95.0|-10.792|6.233|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||6.233|-10.792|0.591
71862536|NCT01055704|143239807|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-34.425|STANDARD_ERROR_OF_MEAN|14.67||0.024|TWO_SIDED|95.0|-64.097|-4.753|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||-4.753|-64.097|0.024
71862537|NCT01055704|143239807|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.181|STANDARD_ERROR_OF_MEAN|13.24||0.989|TWO_SIDED|95.0|-26.962|26.598|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||26.598|-26.962|0.989
71908276|NCT04847141|143339015|SUPERIORITY||Difference in Percentage|0.01||||0.989|TWO_SIDED|95.0|-2.99|3.07||p-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentage of participants with critical COVID-19 illness between C19-IG 20% 2 g dose group and placebo.|Chi-squared||95% CI for percentage difference between C19-IG 20% 2 g dose group and placebo was calculated using the exact unconditional method.|||3.07|-2.99|0.9890
71908277|NCT04058158|143339018|EQUIVALENCE|Pre-defined equivalence margin was \[-337.2 to 337.2\].|Least squares mean difference|34.48|||||TWO_SIDED|95.0|-47.66|116.62||||||||116.62|-47.66|
71908278|NCT04058158|143339019|EQUIVALENCE|Pre-defined equivalence margin was \[0.77 to 1.29\].|Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.95|1.23||||||||1.23|0.95|
71908279|NCT01634113|143339020|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.117||0.4963|TWO_SIDED|95.0|-0.312|0.152||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.152|-0.312|0.4963
71908280|NCT01634113|143339020|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.123||0.6936|TWO_SIDED|95.0|-0.292|0.195||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.195|-0.292|0.6936
71862538|NCT01055704|143239808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.401|STANDARD_ERROR_OF_MEAN|0.211||0.064|TWO_SIDED|95.0|-0.827|0.025|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.025|-0.827|0.064
71862539|NCT01055704|143239808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.19||0.61|TWO_SIDED|95.0|-0.287|0.482|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.482|-0.287|0.610
71862540|NCT01055704|143239809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.728|STANDARD_ERROR_OF_MEAN|0.497||0.151|TWO_SIDED|95.0|-0.278|1.734|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.734|-0.278|0.151
71862541|NCT01055704|143239809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.448||0.806|TWO_SIDED|95.0|-0.795|1.017|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||1.017|-0.795|0.806
71862542|NCT01055704|143239810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.772|STANDARD_ERROR_OF_MEAN|12.583||0.889|TWO_SIDED|95.0|-23.678|27.223|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates||27.223|-23.678|0.889
71862543|NCT01055704|143239810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.607|STANDARD_ERROR_OF_MEAN|11.356||0.274|TWO_SIDED|95.0|-10.362|35.577|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||35.577|-10.362|0.274
71862544|NCT01055704|143239811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.178||0.236|TWO_SIDED|95.0|-0.572|0.145|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.145|-0.572|0.236
71862545|NCT01055704|143239811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.19||0.885|TWO_SIDED|95.0|-0.412|0.357|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.357|-0.412|0.885
71862546|NCT01055704|143239812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.497|STANDARD_ERROR_OF_MEAN|0.374||0.192|TWO_SIDED|95.0|-1.255|0.261|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.261|-1.255|0.192
71908281|NCT01634113|143339022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083|STANDARD_ERROR_OF_MEAN|0.157||0.5995|TWO_SIDED|95.0|-0.229|0.394||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.394|-0.229|0.5995
71908282|NCT01634113|143339022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015|STANDARD_ERROR_OF_MEAN|0.16||0.9251|TWO_SIDED|95.0|-0.303|0.333||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.333|-0.303|0.9251
71908283|NCT01634113|143339023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.25|STANDARD_ERROR_OF_MEAN|10.324||0.8279|TWO_SIDED|95.0|-18.243|22.743||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||22.743|-18.243|0.8279
71908284|NCT01634113|143339023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.497|STANDARD_ERROR_OF_MEAN|10.826||0.8181|TWO_SIDED|95.0|-23.987|18.994||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||18.994|-23.987|0.8181
71908285|NCT01634113|143339025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.061|STANDARD_ERROR_OF_MEAN|0.112||0.5869|TWO_SIDED|95.0|-0.161|0.283||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo|||0.283|-0.161|0.5869
71908286|NCT01634113|143339025|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075|STANDARD_ERROR_OF_MEAN|0.116||0.523|TWO_SIDED|95.0|-0.305|0.156||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo|||0.156|-0.305|0.5230
71908287|NCT02528253|143339046|SUPERIORITY||Least Square (LS) Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1117|TWO_SIDED|95.0|-0.66|0.07|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||0.07|-0.66|0.1117
71908288|NCT02528253|143339046|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0281|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.||-0.04|-0.76|0.0281
71908289|NCT02528253|143339047|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
71908290|NCT02528253|143339047|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
71908291|NCT02528253|143339048|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.17||0.3118|TWO_SIDED|95.0|-0.5|0.16|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.50|0.3118
71681659|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0552||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pneumonia between two groups||||0.0552
71908292|NCT02528253|143339048|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.0958|TWO_SIDED|95.0|-0.6|0.05|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.05|-0.60|0.0958
71908293|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.12||0.0015|TWO_SIDED|95.0|-0.6|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.14|-0.60|0.0015
71908294|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.12||0.0004|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.19|-0.65|0.0004
71908295|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.11||0.0959|TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.03|-0.39|0.0959
71908296|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.11||0.037|TWO_SIDED|95.0|-0.44|-0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.01|-0.44|0.0370
71908297|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.20|-0.76|0.0008
71908298|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.96|-0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.39|-0.96|<.0001
71908299|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0711|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0711
71908300|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.13||0.0661|TWO_SIDED|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.02|-0.50|0.0661
71908301|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.13||0.0009|TWO_SIDED|95.0|-0.7|-0.18|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.18|-0.70|0.0009
71908302|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.16||0.0008|TWO_SIDED|95.0|-0.84|-0.22|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.22|-0.84|0.0008
71908303|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.0|-0.38|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.38|-1.00|<.0001
71908304|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.15||0.0274|TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.04|-0.61|0.0274
71908305|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.15||0.1495|TWO_SIDED|95.0|-0.5|0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.08|-0.50|0.1495
71908306|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.0123|TWO_SIDED|95.0|-0.65|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.08|-0.65|0.0123
71908307|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.17||0.0307|TWO_SIDED|95.0|-0.71|-0.03|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.03|-0.71|0.0307
71908308|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0009|TWO_SIDED|95.0|-0.91|-0.24|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.24|-0.91|0.0009
71908309|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2103|TWO_SIDED|95.0|-0.51|0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.11|-0.51|0.2103
71908310|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.16||0.2656|TWO_SIDED|95.0|-0.48|0.13|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.13|-0.48|0.2656
71908311|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.16||0.0152|TWO_SIDED|95.0|-0.68|-0.07|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||-0.07|-0.68|0.0152
71681660|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0184||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of biliary tract obstruction between two groups||||0.0184
71908312|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.19||0.5164|TWO_SIDED|95.0|-0.5|0.25|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.25|-0.50|0.5164
71908313|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.19||0.1488|TWO_SIDED|95.0|-0.66|0.1|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.10|-0.66|0.1488
71908314|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.19||0.2431|TWO_SIDED|95.0|-0.6|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.15|-0.60|0.2431
71908315|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2428|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.16|-0.62|0.2428
71908316|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4561|TWO_SIDED|95.0|-0.54|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.24|-0.54|0.4561
71908317|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3523|TWO_SIDED|95.0|-0.56|0.2|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.20|-0.56|0.3523
71908318|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.4403|TWO_SIDED|95.0|-0.53|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.23|-0.53|0.4403
71908319|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3205|TWO_SIDED|95.0|-0.58|0.19|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.19|-0.58|0.3205
71908320|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5763|TWO_SIDED|95.0|-0.51|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.28|-0.51|0.5763
71908321|NCT02528253|143339049|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2887|TWO_SIDED|95.0|-0.61|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.||0.18|-0.61|0.2887
71681661|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0931||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of cholangitis between two groups||||0.0931
71908322|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.84|STANDARD_ERROR_OF_MEAN|0.34||0.0121|TWO_SIDED|95.0|-1.5|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-1.50|0.0121
71908323|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.05|-0.71|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.71|-2.05|<.0001
71908324|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.31||0.3697|TWO_SIDED|95.0|-0.89|0.33|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.33|-0.89|0.3697
71908325|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0658|TWO_SIDED|95.0|-1.16|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-1.16|0.0658
71908326|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.31||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.50|-1.70|0.0004
71922081|NCT03091920|143364994|OTHER|No statistical testing was performed.|Least squares mean difference|-3.82|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-11.47|3.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.83|-11.47|
71908327|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.22|STANDARD_ERROR_OF_MEAN|0.38||0.0013|TWO_SIDED|95.0|-1.96|-0.48|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.48|-1.96|0.0013
71908328|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.96|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.7|-1.21|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.21|-2.70|<.0001
71908329|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.35||0.3906|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.39|-0.99|0.3906
71908330|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.35||0.0082|TWO_SIDED|95.0|-1.6|-0.24|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-1.60|0.0082
71908331|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|0.35|<|0.0001|TWO_SIDED|95.0|-2.34|-0.97|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.97|-2.34|<.0001
71862547|NCT01055704|143239812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.063|STANDARD_ERROR_OF_MEAN|0.342||0.855|TWO_SIDED|95.0|-0.756|0.63|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.||0.630|-0.756|0.855
71862548|NCT01430468|143239827|EQUIVALENCE|With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.||||||0.11||||||P-value was calculated. Threshold for statistical significance (p\<0.05)|t-test, 2 sided|||The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p \< 0.05.||||0.11
71862549|NCT03518567|143239849|SUPERIORITY||Slope|0.78||||4e-08|TWO_SIDED||||||Regression, Linear|"hits purchased on the MPT predicting hits actually purchased and smoked in the laboratory.~covariate: baseline total individual income"||||||.00000004
71862550|NCT03518567|143239850|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_DEVIATION|1.09||9e-09|TWO_SIDED||||||t-test, 2 sided|||||||.000000009
71862551|NCT03518567|143239851|SUPERIORITY||correlation|0.02||||0.87|TWO_SIDED||||||correlation|Correlation between puffs on the topography device and grams of cannabis used per week.||||||.87
71862552|NCT02065882|143239886|OTHER|Confirmatory t-test testing of the MCF difference (1 h post-dose minus pre-dose)|||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71862553|NCT00475644|143239927|SUPERIORITY||Odds Ratio (OR)|0.031|||||TWO_SIDED|95.0|0.001|0.86||||||||0.860|0.001|
71862554|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (CI) of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
71862555|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.07||||||Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.07|-1.14|
71862556|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.14|2.08||||||Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.08|-1.14|
71862557|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
71862558|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||TWO_SIDED|95.0|-1.15|2.09||||||Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.09|-1.15|
71681662|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.0506||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of peritonitis between two groups||||0.0506
71681663|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of sepsis between two groups||||1
71681664|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5374||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of diarrhea between two groups||||0.5374
71862559|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||1.40|-1.48|
71862560|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.56|||||TWO_SIDED|95.0|-3.93|2.69||||||Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||2.69|-3.93|
71908332|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|0.4||0.0006|TWO_SIDED|95.0|-2.15|-0.58|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.58|-2.15|0.0006
71908333|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.73|-1.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-1.16|-2.73|<.0001
71908334|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.37||0.0385|TWO_SIDED|95.0|-1.47|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-1.47|0.0385
71908335|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.06|-0.61|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.61|-2.06|0.0003
71908336|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|-2.21|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.43|-2.21|0.0035
71908337|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.46||0.0002|TWO_SIDED|95.0|-2.64|-0.83|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.83|-2.64|0.0002
71908338|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.42||0.5412|TWO_SIDED|95.0|-1.09|0.57|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.57|-1.09|0.5412
71908339|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.42||0.0107|TWO_SIDED|95.0|-1.87|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.87|0.0107
71908340|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.42||0.0004|TWO_SIDED|95.0|-2.29|-0.66|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.66|-2.29|0.0004
71908341|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.49||0.0464|TWO_SIDED|95.0|-1.94|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-1.94|0.0464
71908342|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|0.49||0.0068|TWO_SIDED|95.0|-2.3|-0.37|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||-0.37|-2.30|0.0068
71908343|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.5||0.1485|TWO_SIDED|95.0|-1.7|0.26|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-1.70|0.1485
71908344|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.5||0.0507|TWO_SIDED|95.0|-1.94|0.0|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-1.94|0.0507
71908345|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.51||0.248|TWO_SIDED|95.0|-1.6|0.41|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.41|-1.60|0.2480
71862561|NCT01411241|143239928|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.36|||||TWO_SIDED|95.0|-4.87|4.06||||||Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.||4.06|-4.87|
71862562|NCT02356705|143239937|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71862563|NCT02356705|143239938|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71862564|NCT02356705|143239939|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||0.88
71862565|NCT02356705|143239941|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71862566|NCT02356705|143239942|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71862567|NCT01107899|143239947|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.|Regression, Linear|||||||<0.001
71908346|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.51||0.1605|TWO_SIDED|95.0|-1.71|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-1.71|0.1605
71908347|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.52||0.3654|TWO_SIDED|95.0|-1.5|0.55|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.55|-1.50|0.3654
71862568|NCT01107899|143239949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
71862569|NCT01107899|143239949|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||<0.001
71862570|NCT01107899|143239949|SUPERIORITY_OR_OTHER|||||||0.025||95.0|||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.||||||0.025
71862571|NCT01810939|143240008|SUPERIORITY_OR_OTHER_LEGACY||Proportion|0.76|||||TWO_SIDED|95.0|0.7|0.81||||||||0.81|0.7|
71862572|NCT01810939|143240009|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L||||<0.001
71862573|NCT01810939|143240010|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L||||<0.001
71862574|NCT01810939|143240011|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Longitudinal mixed models|Test that the mean change is significantly different from zero.||Estimation of mean change in serum potassium from Part A Baseline to Part A Week 4 and test mean change different from zero.||||<0.001
71862575|NCT01810939|143240012|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Test for difference between treatment groups in serum potassium change in Part B||||< 0.001
71862576|NCT02349152|143240019|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.|Risk Ratio (RR)|1.9||||0.001|TWO_SIDED|95.0|1.3|3.0|||Chi-squared|||The null hypothesis that there was no difference in the percentage of patients with two or more blood glucose values greater than 180mg/dl between the two groups. Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%.||3.0|1.3|0.001
71862577|NCT02349152|143240020|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||||||0.004
71862578|NCT02349152|143240021|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG\>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.||||||0.01|||||||Fisher Exact|||||||0.01
71862579|NCT02349152|143240022|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0001|||||||t-test, 2 sided|||Mean Intraoperative Blood Glucose||||0.0001
71908348|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1782|TWO_SIDED|95.0|-1.71|0.32|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.32|-1.71|0.1782
71922082|NCT03091920|143364994|OTHER|No statistical testing was performed.|Least squares mean difference|1.42|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-6.1|8.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.94|-6.10|
71922083|NCT03091920|143364994|OTHER|No statistical testing was performed.|Least squares mean difference|-6.44|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-16.36|3.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||3.47|-16.36|
71681665|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of anorexia between two groups||||0.14
71681666|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.4584||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of abdominal pain between two groups||||0.4584
71681667|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of skin rash between two groups||||1
71862580|NCT02349152|143240022|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0003|||||||t-test, 2 sided|||Peak Intraoperative Blood Glucose||||0.0003
71862581|NCT02349152|143240022|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.98|||||||t-test, 2 sided|||Lowest Intraoperative Blood Glucose||||0.98
71862582|NCT02349152|143240023|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.14|||||||t-test, 2 sided|||Mean post-operative glucose||||0.14
71862583|NCT02349152|143240023|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.25|||||||t-test, 2 sided|||Peak Postoperative Blood Glucose||||0.25
71862584|NCT02349152|143240024|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.49|||||||t-test, 2 sided|||||||0.49
71862585|NCT02349152|143240026|SUPERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.401|||||||t-test, 2 sided|||Prebypass||||0.401
71862586|NCT02349152|143240026|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||30 minutes after the start of CPB||||<0.0001
71862587|NCT02349152|143240026|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of CPB||||<0.0001
71862588|NCT02349152|143240026|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of Surgery||||<0.0001
71862589|NCT02349152|143240026|NON_INFERIORITY|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG \> 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.021|||||||t-test, 2 sided|||Postoperative (8 hours)||||0.021
71862590|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.58|||||||t-test, 2 sided|||Analyzing the IL-1b Pre bypass||||0.580
71862591|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.815|||||||t-test, 2 sided|||Analyzing the IL-1b CPB-30||||0.815
71862592|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.715|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.715
71862593|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.33|||||||t-test, 2 sided|||Analyzing the IL-1b post-bypass||||0.330
71862594|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.651|||||||t-test, 2 sided|||Analyzing the IL-1b 8 HR||||0.651
71862595|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.439|||||||t-test, 2 sided|||Analyzing the IL-6 Pre bypass||||0.439
71862596|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.284|||||||t-test, 2 sided|||Analyzing the IL-6 CPB-30||||0.284
71862597|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.779|||||||t-test, 2 sided|||Analyzing the CPB-END||||0.779
71862598|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.274|||||||t-test, 2 sided|||Analyzing the IL-6 post-bypass||||0.274
71908349|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.3981|TWO_SIDED|95.0|-1.47|0.58|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.58|-1.47|0.3981
71908350|NCT02528253|143339051|SUPERIORITY||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|0.52||0.1089|TWO_SIDED|95.0|-1.84|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-1.84|0.1089
71862599|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.601|||||||t-test, 2 sided|||Analyzing the IL-6 8HR||||0.601
71862600|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.315|||||||t-test, 2 sided|||Analyzing the TNFa Pre-bypass||||0.315
71862601|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the TNFa CPB-30||||0.062
71862602|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.09|||||||t-test, 2 sided|||Analyzing the TNFa CPB-END||||0.090
71862603|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||Analyzing the TNFa- post-bypass||||0.004
71922084|NCT03091920|143364994|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|4.52|||TWO_SIDED|95.0|-10.44|8.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||8.38|-10.44|
71862604|NCT02349152|143240027|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.074|||||||t-test, 2 sided|||Analyzing the TNFa-8HR||||0.074
71862605|NCT02349152|143240028|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.74|||||||t-test, 2 sided|||Analyzing the ACTH Pre-bypass group||||0.740
71862606|NCT02349152|143240028|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-30 group.||||<0.0001
71862607|NCT02349152|143240028|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-END||||<0.0001
71862608|NCT02349152|143240028|NON_INFERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH post-bypass||||<0.0001
71862609|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.014|||||||t-test, 2 sided|||Analyzing the ACTH 8-hr||||0.014
71862610|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.1|||||||t-test, 2 sided|||Analyzing the GH- Pre-bypass||||0.100
71862611|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||GH-CPB-30||||<0.0001
71922085|NCT03091920|143364995|OTHER|No statistical testing was performed.|Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-6.97|6.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.54|-6.97|
71681668|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of palmar-plantar erythrodysesthesia syndrome between two groups||||1
71681669|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypertension between two groups||||1
71681670|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.5958||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hemorrhage between two groups||||0.5958
71681671|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||0.14||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypoglycemia between two groups||||0.14
71862612|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.009|||||||t-test, 2 sided|||Analyzing the GH-CPB-END||||0.009
71862613|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.046|||||||t-test, 2 sided|||GH-Post-bypass||||0.046
71862614|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.695|||||||t-test, 2 sided|||Analyzing the GH-8-hr||||0.695
71862615|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.455|||||||t-test, 2 sided|||Analyzing the Glucagon Pre Bypass||||0.455
71862616|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.059|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-30||||0.059
71862617|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.175|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-END||||0.175
71862618|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the Glucagon Post-bypass||||0.062
71908351|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.1472|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1472
71862619|NCT02349152|143240028|SUPERIORITY|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.261|||||||t-test, 2 sided|||Analyzing the Glucagon 8-hr||||0.261
71862620|NCT02349152|143240029|SUPERIORITY|||||||0.06|||||||Chi-squared|||30-day mortality||||0.06
71862621|NCT02349152|143240029|SUPERIORITY|||||||0.03|||||||Chi-squared|||30-day readmission||||0.03
71862622|NCT02349152|143240029|SUPERIORITY|||||||0.24|||||||Chi-squared|||Cerebral Vascular Accident||||0.24
71862623|NCT02349152|143240029|SUPERIORITY|||||||0.93|||||||Chi-squared|||Prolonged Mechanical Ventilation||||0.93
71862624|NCT02349152|143240029|SUPERIORITY|||||||1|||||||Chi-squared|||Renal Failure||||1
71862625|NCT02349152|143240029|SUPERIORITY|||||||0.1|||||||Chi-squared|||Atrial Fibrillation||||0.10
71862626|NCT02349152|143240029|SUPERIORITY|||||||1|||||||Chi-squared|||cardiac arrest||||1
71862627|NCT02349152|143240030|SUPERIORITY|||||||0.205|||||||t-test, 2 sided|||Hrs 0-6||||0.205
71862628|NCT02349152|143240030|SUPERIORITY|||||||0.339|||||||t-test, 2 sided|||Hrs 7-12||||0.339
71862629|NCT02349152|143240030|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Hrs 13-18||||0.006
71862630|NCT02349152|143240030|SUPERIORITY|||||||0.747|||||||t-test, 2 sided|||Hrs 19-24||||0.747
71862631|NCT02349152|143240030|SUPERIORITY|||||||0.568|||||||t-test, 2 sided|||Hrs 25-30||||0.568
71862632|NCT02349152|143240030|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||Hrs 31-36||||0.924
71862633|NCT02349152|143240030|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Hrs 37-42||||0.501
71862634|NCT02349152|143240030|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||Hrs 43-48||||0.977
71862635|NCT02349152|143240034|SUPERIORITY|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.350
71862636|NCT03054337|143240038|SUPERIORITY||Least squares mean difference|0.9|STANDARD_ERROR_OF_MEAN|0.301||0.0045|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|The analysis of covariance (ANCOVA) model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||1.51|0.29|0.0045
71862637|NCT03054337|143240038|SUPERIORITY||Least squares mean difference|1.59|STANDARD_ERROR_OF_MEAN|0.306|<|0.0001|TWO_SIDED|95.0|0.98|2.21|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.21|0.98|<0.0001
71862638|NCT03054337|143240038|SUPERIORITY||Least squares mean difference|2.09|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|1.49|2.7|||ANCOVA|The ANCOVA model included treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||||2.70|1.49|<0.0001
71862639|NCT03054337|143240044|SUPERIORITY||Least squares mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.103||0.0018|TWO_SIDED|95.0|0.13|0.55|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.55|0.13|0.0018
71862640|NCT03054337|143240044|SUPERIORITY||Least squares mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.103|<|0.0001|TWO_SIDED|95.0|0.3|0.72|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.72|0.30|<0.0001
71862641|NCT03054337|143240044|SUPERIORITY||Least squares mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|0.45|0.86|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||RBC Count||0.86|0.45|<0.0001
71862642|NCT03054337|143240044|SUPERIORITY||Least squares mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.005||0.7804|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.01|-0.01|0.7804
71862643|NCT03054337|143240044|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.0986|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.0986
71922086|NCT03091920|143364995|OTHER|No statistical testing was performed.|Least squares mean difference|-1.6|STANDARD_ERROR_OF_MEAN|3.2|||TWO_SIDED|95.0|-8.24|5.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||5.03|-8.24|
71862644|NCT03054337|143240044|SUPERIORITY||Least squares mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.005||0.1661|TWO_SIDED|95.0|0.0|0.02|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Absolute Reticulocyte Count||0.02|-0.00|0.1661
71681672|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hyperglycemia between two groups||||1
71862645|NCT03054337|143240046|SUPERIORITY||Least squares mean difference|3.3|STANDARD_ERROR_OF_MEAN|0.942||0.001|TWO_SIDED|95.0|1.4|5.2|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||5.20|1.40|0.0010
71681673|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of hypocalcemia between two groups||||1
71862646|NCT03054337|143240046|SUPERIORITY||Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|0.953|<|0.0001|TWO_SIDED|95.0|3.38|7.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||7.22|3.38|<0.0001
71862647|NCT03054337|143240046|SUPERIORITY||Least squares mean difference|7.24|STANDARD_ERROR_OF_MEAN|0.93|<|0.0001|TWO_SIDED|95.0|5.37|9.11|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Hematocrit||9.11|5.37|<0.0001
71862648|NCT03054337|143240046|SUPERIORITY||Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.152||0.5889|TWO_SIDED|95.0|-0.39|0.22|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.22|-0.39|0.5889
71862649|NCT03054337|143240046|SUPERIORITY||Least squares mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.151||0.8074|TWO_SIDED|95.0|-0.27|0.34|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.34|-0.27|0.8074
71862650|NCT03054337|143240046|SUPERIORITY||Least squares mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.148||0.6952|TWO_SIDED|95.0|-0.36|0.24|||ANCOVA|The ANCOVA model will include treatment assignment (3 dosed groups; 1 placebo group) and pre-treatment Hb value as a covariate.||Reticulocytes||0.24|-0.36|0.6952
71862651|NCT03054337|143240048|SUPERIORITY|||||||0.3702|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.3702
71862652|NCT03054337|143240048|SUPERIORITY|||||||0.5524|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.5524
71862653|NCT03054337|143240048|SUPERIORITY|||||||0.1589|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Iron||||0.1589
71862654|NCT03054337|143240048|SUPERIORITY|||||||0.0092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||0.0092
71862655|NCT03054337|143240048|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
71681674|NCT01935700|142881614|EQUIVALENCE|The threshold for statistically significant difference in incidence was P = 0.05.||||||1||||||The threshold for statistically significant difference in incidence was P = 0.05.|Fisher Exact|||Comparison the incidence of grade III adverse event of pleural effusion between two groups||||1
71862656|NCT03054337|143240048|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||TIBC||||<0.0001
71862657|NCT03054337|143240050|SUPERIORITY|||||||0.9092|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.9092
71862658|NCT03054337|143240050|SUPERIORITY|||||||0.1484|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1484
71862659|NCT03054337|143240050|SUPERIORITY|||||||0.1313|||||||ANCOVA|test of treatment group difference based on ANCOVA model||||||0.1313
71862660|NCT03054337|143240052|SUPERIORITY|||||||0.108|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.1080
71862661|NCT03054337|143240052|SUPERIORITY|||||||0.0002|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||0.0002
71862662|NCT03054337|143240052|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Ferritin||||<0.0001
71862663|NCT03054337|143240052|SUPERIORITY|||||||0.0672|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0672
71862664|NCT03054337|143240052|SUPERIORITY|||||||0.0004|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||0.0004
71862665|NCT03054337|143240052|SUPERIORITY||||||<|0.0001|||||||ANCOVA|test of treatment group difference based on ANCOVA model||Hepcidin||||<0.0001
71862666|NCT03054337|143240059|SUPERIORITY|||||||0.0895|||||||Fisher Exact|||||||0.0895
71862667|NCT03054337|143240059|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71862668|NCT03054337|143240059|SUPERIORITY|||||||0.3845|||||||Fisher Exact|||||||0.3845
71862669|NCT01150461|143240064|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.02
71862670|NCT01150461|143240065|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test||||0.06
71862671|NCT01681992|143240066|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-5.48|||||TWO_SIDED|97.5|-7.65|-3.43|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-3.43|-7.65|
71862672|NCT01681992|143240066|NON_INFERIORITY|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-2.08|||||TWO_SIDED|97.5|-3.96|-0.27|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.||-0.27|-3.96|
71862673|NCT01681992|143240067|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.42|||||TWO_SIDED|97.5|-1.91|1.04|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||1.04|-1.91|
71862674|NCT01681992|143240067|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.58|||||TWO_SIDED|97.5|-2.11|0.91|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||0.91|-2.11|
71862675|NCT01681992|143240068|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-9.41|||||TWO_SIDED|97.5|-13.2|-5.62|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-5.62|-13.20|
71862676|NCT01681992|143240068|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-7.22|||||TWO_SIDED|97.5|-10.94|-3.49|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.||-3.49|-10.94|
71862677|NCT01681992|143240069|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Min minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.71|||||TWO_SIDED|97.5|-3.11|-0.42|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Min vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||-0.42|-3.11|
71681675|NCT00231283|142881615|SUPERIORITY_OR_OTHER||Percentage of participants|97.0|STANDARD_ERROR_OF_MEAN|1.71||||95.0|91.5|99.4|||Qualitative Comparison|Reported in qualitative/semi-quantitative comparitive fashion due to study design.||||99.4|91.5|
71681676|NCT00231283|142881616|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.6|||No formal statistical testing|||||8.6|0.6|
71681677|NCT00231283|142881617|SUPERIORITY_OR_OTHER||Percentage of participants|3.0||||||95.0|0.6|8.5|||Descriptive statistics|||||8.5|0.6|
71681678|NCT00231283|142881618|SUPERIORITY_OR_OTHER||Percentage of participants|10.4||||||95.0|5.1|18.3|||Descriptive statistics|||||18.3|5.1|
71862678|NCT01681992|143240069|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group difference (Inv\_MMR\_Med minus Com\_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.18|||||TWO_SIDED|97.5|-2.5|0.05|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv\_MMR\_Med vaccine compared to Com\_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.||0.05|-2.50|
71862679|NCT01681992|143240070|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.79|||||TWO_SIDED|97.5|0.72|0.88|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||0.88|0.72|
71862680|NCT01681992|143240070|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.91|||||TWO_SIDED|97.5|0.83|1.01|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.||1.01|0.83|
71862681|NCT01681992|143240071|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.82|||||TWO_SIDED|97.5|0.76|0.89|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.89|0.76|
71862682|NCT01681992|143240071|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.84|||||TWO_SIDED|97.5|0.78|0.91|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.91|0.78|
71862683|NCT01681992|143240072|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.6|||||TWO_SIDED|97.5|0.53|0.68|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.68|0.53|
71862684|NCT01681992|143240072|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.65|||||TWO_SIDED|97.5|0.57|0.74|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed titers with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.||0.74|0.57|
71862685|NCT01681992|143240073|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Min over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.89|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Min vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
71908352|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.05||0.0135|TWO_SIDED|95.0|-0.24|-0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.24|0.0135
71862686|NCT01681992|143240073|NON_INFERIORITY|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv\_MMR\_Med over pooled Com\_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.88|||||TWO_SIDED|97.5|0.83|0.95|||ANOVA|97.5% CI for GMC ratio was computed using ANOVA model on the log-transformed concentrations with vaccine group and the country as fixed effects.||Non-inferiority of Inv\_MMR\_Med vaccine compared to COM\_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.||0.95|0.83|
71862687|NCT02838979|143240103|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.34||0.15|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.15
71862688|NCT02838979|143240104|SUPERIORITY||Mean Difference (Final Values)|-7.39|STANDARD_DEVIATION|22.18||0.86|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.86
71862689|NCT02838979|143240105|SUPERIORITY||Median Difference (Final Values)|-0.1|STANDARD_DEVIATION|1.04||0.44|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.44
71862690|NCT02838979|143240106|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.21||0.36|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.36
71862691|NCT02838979|143240107|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_DEVIATION|7.87||0.6|TWO_SIDED|||||P-value for the interaction of treatment and sequence|ANOVA|Two-way ANOVA was used to assess differences between the groups||||||0.60
71681679|NCT01225289|142881619|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.01
71688751|NCT03951753|142892918|OTHER||Least Squares Mean Difference|381.23|STANDARD_ERROR_OF_MEAN|21.399|<|0.001|TWO_SIDED|95.0|339.29|423.17|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||423.17|339.29|<0.001
71862692|NCT01762904|143240109|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71688752|NCT03951753|142892918|OTHER||Least Squares Mean Difference|102.09|STANDARD_ERROR_OF_MEAN|25.635|<|0.001|TWO_SIDED|95.0|51.84|152.33|||ANCOVA|Data were analysed with ANCOVA in log transformed data.|Data were analysed with ANCOVA in log transformed data. Results were converted back to original scale.|||152.33|51.84|<0.001
71908353|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.05||0.0893|TWO_SIDED|95.0|-0.18|0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.18|0.0893
71908354|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.0044|TWO_SIDED|95.0|-0.23|-0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.23|0.0044
71908355|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.0025|TWO_SIDED|95.0|-0.28|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.28|0.0025
71908356|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.32|0.0002
71908357|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.05||0.8348|TWO_SIDED|95.0|-0.11|0.09|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.11|0.8348
71908358|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.05||0.002|TWO_SIDED|95.0|-0.26|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.26|0.0020
71908359|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.05||0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.30|0.0001
71908360|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0272|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0272
71908361|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0009|TWO_SIDED|95.0|-0.31|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.31|0.0009
71908362|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.05||0.168|TWO_SIDED|95.0|-0.18|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.18|0.1680
71908363|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.05||0.2968|TWO_SIDED|95.0|-0.16|0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.16|0.2968
71908364|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0219|TWO_SIDED|95.0|-0.23|-0.02|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.23|0.0219
71908365|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0717|TWO_SIDED|95.0|-0.25|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.25|0.0717
71922087|NCT03091920|143364995|OTHER|No statistical testing was performed.|Least squares mean difference|-3.12|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.88|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||4.65|-10.88|
71862693|NCT01762904|143240110|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71862694|NCT01762904|143240111|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71862695|NCT01028677|143240114|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 1 sided|||Analysis of fear emotion||||.61
71862696|NCT01028677|143240115|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||Positive Symptoms||||0.008
71862697|NCT01028677|143240115|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||Negative Symptoms||||0.002
71862698|NCT01028677|143240115|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||General Symptoms||||0.04
71862699|NCT01028677|143240115|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Positive Symptoms||||0.05
71862700|NCT01028677|143240115|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Negative Symptoms||||0.08
71862701|NCT01028677|143240115|SUPERIORITY|||||||0.025|||||||t-test, 2 sided|||General Symptoms||||0.025
71862702|NCT01028677|143240117|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||||||.03
71862703|NCT01028677|143240119|SUPERIORITY_OR_OTHER|||||||0.784|TWO_SIDED|||||Not adjusted for multiple comparisons|t-test, 2 sided|||IRI-total||||.784
71862704|NCT01028677|143240119|SUPERIORITY_OR_OTHER|||||||1|||||||t-test, 2 sided|||Distress analysis||||1.00
71862705|NCT01028677|143240119|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||Perspective-Taking||||.03
71908366|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0207|TWO_SIDED|95.0|-0.29|-0.02|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.29|0.0207
71862706|NCT01028677|143240119|SUPERIORITY_OR_OTHER|||||||0.135|||||||t-test, 2 sided|||Emotional empathy analysis||||.135
71862707|NCT01028677|143240119|SUPERIORITY_OR_OTHER|||||||0.681|TWO_SIDED||||||t-test, 2 sided|||Fantasy Analysis||||.681
71862708|NCT01028677|143240119|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||t-test, 2 sided|||Distress analysis||||1.00
71862709|NCT04148989|143240120|SUPERIORITY||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-18.6|-7.0|||Regression, gamma||Change in emergency department door-to-antibiotic time (minutes) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||-7.0|-18.6|<0.001
71862710|NCT04148989|143240121|SUPERIORITY||Odds Ratio (OR)|0.89||||0.45|TWO_SIDED|95.0|0.68|1.19|||Regression, Logistic||Change in all-cause 30-day mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.19|0.68|0.45
71862711|NCT04148989|143240122|SUPERIORITY||Odds Ratio (OR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Logistic||Change in all-cause 1-year mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.04|0.67|0.10
71862712|NCT04148989|143240123|SUPERIORITY||Odds Ratio (OR)|0.77||||0.15|TWO_SIDED|95.0|0.53|1.1|||Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Change in all-cause in-hospital mortality risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|1.10|0.53|0.15
71862713|NCT04148989|143240124|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.71|TWO_SIDED|95.0|-1.4|2.1|||Regression, gamma||Change in hospital charges ($1000s) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.1|-1.4|0.71
71862714|NCT04148989|143240125|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.19|TWO_SIDED|95.0|-0.4|0.1|||Regression, gamma||Change in hospital length of stay (days) associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable gamma regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.1|-0.4|0.19
71862715|NCT04148989|143240126|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.1||||0.005|TWO_SIDED|95.0|1.03|1.17||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic||Change in antimicrobial treatment risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.17|1.03|0.005
71922088|NCT03091920|143364995|OTHER|No statistical testing was performed.|Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-8.45|6.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||6.80|-8.45|
71862716|NCT04148989|143240127|SUPERIORITY||Odds Ratio (OR)|1.09||||0.73|TWO_SIDED|95.0|0.68|1.75|||Regression, Logistic||Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||1.75|0.68|0.73
71862717|NCT04148989|143240128|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.02||||0.9|TWO_SIDED|95.0|0.78|1.33||Model adjusted for age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.|Regression, Logistic|||Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.|Change in risk for possible antimicrobial-associated adverse event associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|1.33|0.78|0.90
71908367|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8399|TWO_SIDED|95.0|-0.11|0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.11|0.8399
71908368|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.06||0.0299|TWO_SIDED|95.0|-0.25|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.25|0.0299
71908369|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.29|-0.05|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.29|0.0060
71908370|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.1974|TWO_SIDED|95.0|-0.24|0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.24|0.1974
71908371|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.278|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.22|0.2780
71908372|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.433|TWO_SIDED|95.0|-0.21|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.21|0.4330
71908373|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.4946|TWO_SIDED|95.0|-0.2|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.20|0.4946
71908374|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.1884|TWO_SIDED|95.0|-0.25|0.05|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.25|0.1884
71908375|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.521|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.20|0.5210
71908376|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.3329|TWO_SIDED|95.0|-0.23|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.23|0.3329
71908377|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.08||0.5173|TWO_SIDED|95.0|-0.21|0.1|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.21|0.5173
71908378|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.2346|TWO_SIDED|95.0|-0.25|0.06|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.25|0.2346
71688753|NCT03951753|142892919|OTHER||Least Squares Mean Difference|11.3|||<|0.001|TWO_SIDED|95.0|4.9|17.7|||ANCOVA|||||17.7|4.9|<0.001
71908379|NCT02528253|143339053|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.08||0.3634|TWO_SIDED|95.0|-0.23|0.09|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.23|0.3634
71908380|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0007|TWO_SIDED|95.0|1.26|2.39|||Regression, Logistic|||Week 2, \>=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.26|0.0007
71908381|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0004|TWO_SIDED|95.0|1.29|2.44|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|1.29|0.0004
71908382|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3456|TWO_SIDED|95.0|0.87|1.5|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.87|0.3456
71908383|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2771|TWO_SIDED|95.0|0.89|1.53|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.89|0.2771
71908384|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0594|TWO_SIDED|95.0|0.98|2.41|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.41|0.98|0.0594
71908385|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0105|TWO_SIDED|95.0|1.14|2.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.75|1.14|0.0105
71908386|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.29||||0.236|TWO_SIDED|95.0|0.85|1.98|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|0.85|0.2360
71908387|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.19||||0.3746|TWO_SIDED|95.0|0.81|1.75|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|0.81|0.3746
71908388|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0974|TWO_SIDED|95.0|0.94|1.99|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.94|0.0974
71908389|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.94||||0.0806|TWO_SIDED|95.0|0.92|4.08|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.08|0.92|0.0806
71908390|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.15||||0.0407|TWO_SIDED|95.0|1.03|4.47|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.47|1.03|0.0407
71908391|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5966|TWO_SIDED|95.0|0.58|2.58|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.58|0.58|0.5966
71908392|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.59||||0.1492|TWO_SIDED|95.0|0.85|2.96|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.96|0.85|0.1492
71908393|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.76||||0.072|TWO_SIDED|95.0|0.95|3.24|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.24|0.95|0.0720
71908394|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9926|TWO_SIDED|95.0|0.25|4.0|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.00|0.25|0.9926
71908395|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.75||||0.3726|TWO_SIDED|95.0|0.51|6.04|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.04|0.51|0.3726
71908396|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.83||||0.7874|TWO_SIDED|95.0|0.22|3.12|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.22|0.7874
71908397|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.19||||0.795|TWO_SIDED|95.0|0.32|4.46|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.46|0.32|0.7950
71908398|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2065|TWO_SIDED|95.0|0.66|6.68|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||6.68|0.66|0.2065
71908399|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0006|TWO_SIDED|95.0|1.23|2.17|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.17|1.23|0.0006
71908400|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.55|2.72|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.72|1.55|<.0001
71688754|NCT03951753|142892919|OTHER||Least Squares Mean Difference|19.8|||<|0.001|TWO_SIDED|95.0|13.4|26.1|||ANCOVA|||||26.1|13.4|<0.001
71862718|NCT04148989|143240129|SUPERIORITY||Odds Ratio (OR)|1.03||||0.94|TWO_SIDED|95.0|0.49|2.17|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||2.17|0.49|0.94
71862719|NCT04148989|143240130|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.6% of eligible patients.|Odds Ratio (OR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.14|||Regression, Logistic||Change in new-onset Clostridium difficile colitis risk associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis.|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||2.14|0.93|0.10
71862720|NCT04148989|143240131|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 3.1% of eligible patients.|Odds Ratio (OR)|1.15||||0.59|TWO_SIDED|95.0|0.69|1.93|||Regression, Logistic||Change in risk for antimicrobial administration in the ED associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable logistic regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||1.93|0.69|0.59
71862721|NCT04148989|143240132|SUPERIORITY||Mean Difference (Final Values)|0.32||||0.02|TWO_SIDED|95.0|0.06|0.58|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable ??? regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for subjects' age, sex, Elixhauser Comorbidity Score, ED arrival via ambulance, English language preference, temperature, systolic blood pressure, Acute Physiology Score, Sequential Organ Failure Assessment score, and ED-diagnosed source of infection.||0.58|0.06|0.02
71862722|NCT04148989|143240133|SUPERIORITY|Multiple imputation was employed to account for missing covariate data affecting 2.0% of eligible patients.|Mean Difference (Final Values)|0.17||||0.02|TWO_SIDED|95.0|0.03|0.31|||Regression, Linear||Change in total spectrum score of antibiotics administered within 24 hours of ED arrival associated with Code Sepsis implementation derived from adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable linear regression to estimate the change in outcome after versus before intervention implementation at the intervention site adjusted for the change observed at control sites and for prespecified covariates.||0.31|0.03|0.02
71862723|NCT00706654|143240150|NON_INFERIORITY_OR_EQUIVALENCE|The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.|Mean Difference (Final Values)|-0.64||||0.7871|TWO_SIDED|95.0|-5.26|3.99|||z-statistics||The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.|Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.||3.99|-5.26|0.7871
71862724|NCT00706654|143240150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.68||||0.0006|TWO_SIDED|95.0|-23.09|-6.27||Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).|z-statistics|The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.||For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.||-6.27|-23.09|0.0006
71862725|NCT00706654|143240152|SUPERIORITY_OR_OTHER|||||||0.875||95.0|||||z-statistics|||||||0.8750
71862726|NCT00706654|143240152|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||z-statistics|||||||0.0001
71862727|NCT00706654|143240153|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||z-statistics|||||||0.3700
71862728|NCT00706654|143240153|SUPERIORITY_OR_OTHER|||||||0.1097||95.0|||||z-statistics|||||||0.1097
71862729|NCT00594022|143240165|SUPERIORITY_OR_OTHER|||||||0.1275|||||||t-test, 1 sided|||||||.1275
71862730|NCT01151215|143240186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.485|TWO_SIDED|95.0|0.77|1.75||Statistical significance threshold at this interim analysis was 5%|Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \<1 favours AZD8931 40mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||1.75|0.77|0.485
71908401|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0387|TWO_SIDED|95.0|1.01|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.01|0.0387
71908402|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.24||||0.0903|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.60|0.97|0.0903
71862731|NCT01151215|143240186|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.37||||0.135|TWO_SIDED|95.0|0.91|2.06|||Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio \< 1 favours AZD8931 20mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.||2.06|0.91|0.135
71862732|NCT03392168|143240207|SUPERIORITY||Least squares mean difference|-28.5||||0.0007|TWO_SIDED|95.0|-44.6|-12.4|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-12.4|-44.6|0.0007
71862733|NCT03392168|143240207|SUPERIORITY||Least squares mean difference|-27.8||||0.0011|TWO_SIDED|95.0|-44.2|-11.5|||Mixed Models Analysis|||LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-11.5|-44.2|0.0011
71862734|NCT03392168|143240208|SUPERIORITY||Least squares mean difference|-3.2||||0.5493|TWO_SIDED|95.0|-13.7|7.3|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.3|-13.7|0.5493
71862735|NCT03392168|143240208|SUPERIORITY||Least squares mean difference|-4.9||||0.365|TWO_SIDED|95.0|-15.7|5.9|||Mixed Models Analysis|||At week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.9|-15.7|0.3650
71862736|NCT03392168|143240208|SUPERIORITY||Least squares mean difference|-18.3||||0.0064|TWO_SIDED|95.0|-31.3|-5.3|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-5.3|-31.3|0.0064
71862737|NCT03392168|143240208|SUPERIORITY||Least squares mean difference|-19.8||||0.0039|TWO_SIDED|95.0|-33.0|-6.5|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.5|-33.0|0.0039
71862738|NCT03392168|143240208|SUPERIORITY||Least squares mean difference|-28.9||||0.0001|TWO_SIDED|95.0|-42.9|-14.8|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-14.8|-42.9|0.0001
71862739|NCT03392168|143240208|SUPERIORITY||Least squares mean difference|-23.0||||0.0019|TWO_SIDED|95.0|-37.3|-8.7|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-8.7|-37.3|0.0019
71862740|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-4.3||||0.3626|TWO_SIDED|95.0|-13.6|5.0|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.0|-13.6|0.3626
71862741|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-8.1||||0.1011|TWO_SIDED|95.0|-17.8|1.6|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||1.6|-17.8|0.1011
71862742|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-15.5||||0.0017|TWO_SIDED|95.0|-25.1|-6.0|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-6.0|-25.1|0.0017
71862743|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-19.3||||0.0002|TWO_SIDED|95.0|-29.1|-9.4|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-9.4|-29.1|0.0002
71862744|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-21.3||||0.0003|TWO_SIDED|95.0|-32.4|-10.2|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.2|-32.4|0.0003
71862745|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-21.8||||0.0003|TWO_SIDED|95.0|-33.2|-10.4|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.4|-33.2|0.0003
71862746|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-18.7||||0.001|TWO_SIDED|95.0|-29.5|-7.8|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-7.8|-29.5|0.0010
71862747|NCT03392168|143240209|SUPERIORITY||Least squares mean difference|-21.8||||0.0002|TWO_SIDED|95.0|-32.9|-10.6|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-10.6|-32.9|0.0002
71681680|NCT01606202|142881623|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.08||||0.708|TWO_SIDED|95.0|-0.51|0.35|||ANCOVA|||The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.||0.35|-0.51|0.708
71862748|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|2.67||||0.3209|TWO_SIDED|95.0|-2.65|7.99|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||7.99|-2.65|0.3209
71688755|NCT03951753|142892919|OTHER||Least Squares Mean Difference|8.5||||0.003|TWO_SIDED|95.0|3.0|14.0|||ANCOVA|||||14.0|3.0|0.003
71688756|NCT03951753|142892920|OTHER||Least Squares Mean Difference|-3.6|||<|0.001|TWO_SIDED|95.0|-5.5|-1.8|||ANCOVA|||||-1.8|-5.5|<0.001
71681681|NCT01606202|142881624|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.57||||0.852|TWO_SIDED|95.0|-6.62|5.48|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.||5.48|-6.62|0.852
71688757|NCT03951753|142892920|OTHER||Least Squares Mean Difference|-4.5|||<|0.001|TWO_SIDED|95.0|-6.3|-2.6|||ANCOVA|||||-2.6|-6.3|<0.001
71862749|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|3.6||||0.1947|TWO_SIDED|95.0|-1.88|9.08|||Mixed Models Analysis|||At Week 1; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||9.08|-1.88|0.1947
71862750|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|-4.58||||0.3561|TWO_SIDED|95.0|-14.4|5.24|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||5.24|-14.40|0.3561
71862751|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|-5.82||||0.249|TWO_SIDED|95.0|-15.79|4.16|||Mixed Models Analysis|||At Week 2; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.16|-15.79|0.2490
71862752|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|-12.68||||0.0276|TWO_SIDED|95.0|-23.992|-1.44|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.44|-23.992|0.0276
71862753|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|-7.04||||0.2223|TWO_SIDED|95.0|-18.44|4.36|||Mixed Models Analysis|||At Week 3; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||4.36|-18.44|0.2223
71862754|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|-20.27||||0.0108|TWO_SIDED|95.0|-35.72|-4.82|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-4.82|-35.72|0.0108
71862755|NCT03392168|143240210|SUPERIORITY||Least squares mean difference|-16.67||||0.0372|TWO_SIDED|95.0|-32.34|-1.01|||Mixed Models Analysis|||At Week 4; LS mean difference from vehicle; Estimates for LS means and accompanying 95% confidence intervals and P values are from a mixed model for repeated measures (MMRM) with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects, and baseline value as a covariate.||-1.01|-32.34|0.0372
71862756|NCT01721954|143240211|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.43|TWO_SIDED|95.0|||||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.||||0.43
71862757|NCT01721954|143240212|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED||||||Log Rank|||A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.||||<0.05
71908403|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0006|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.21|0.0006
71908404|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0166|TWO_SIDED|95.0|1.08|2.09|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.09|1.08|0.0166
71688758|NCT03951753|142892920|OTHER||Least Squares Mean Difference|-0.8||||0.277|TWO_SIDED|95.0|-2.4|0.7|||ANCOVA|||||0.7|-2.4|0.277
71862758|NCT03274895|143240258|NON_INFERIORITY|Non-inferiority margin= 0.20|difference in proportion of resolution r|-0.036|||||TWO_SIDED|95.0|-0.154|0.081||||||||0.081|-0.154|
71862759|NCT03274895|143240259|OTHER|||||||0.042|||||||Log Rank|||||||0.042
71862760|NCT03274895|143240260|OTHER|||||||0.577|||||||ANCOVA|||||||0.577
71862761|NCT00401258|143240262|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71862762|NCT00401258|143240263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain severity statistical analysis||||<.001
71862763|NCT00401258|143240263|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||Average pain interference statistical analysis||||<.001
71862764|NCT00401258|143240264|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||.001
71862765|NCT00401258|143240265|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71862766|NCT00401258|143240267|SUPERIORITY_OR_OTHER|||||||0.031|||||||Mixed Models Analysis|||||||0.031
71862767|NCT00401258|143240268|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71908405|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.89||||0.0001|TWO_SIDED|95.0|1.36|2.62|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.62|1.36|0.0001
71908406|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1389|TWO_SIDED|95.0|0.93|1.73|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.73|0.93|0.1389
71908407|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2504|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2504
71908408|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0057|TWO_SIDED|95.0|1.12|1.98|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.98|1.12|0.0057
71908409|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0126|TWO_SIDED|95.0|1.14|2.93|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.93|1.14|0.0126
71908410|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.69|||<|0.0001|TWO_SIDED|95.0|1.71|4.22|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||4.22|1.71|<.0001
71908411|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3485|TWO_SIDED|95.0|0.79|1.99|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|0.79|0.3485
71908412|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0642|TWO_SIDED|95.0|0.98|2.19|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.98|0.0642
71908413|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.16|||<|0.0001|TWO_SIDED|95.0|1.48|3.14|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.14|1.48|<.0001
71908414|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9819|TWO_SIDED|95.0|0.42|2.31|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.31|0.42|0.9819
71908415|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4333|TWO_SIDED|95.0|0.62|3.02|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.02|0.62|0.4333
71908416|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.91||||0.814|TWO_SIDED|95.0|0.41|2.0|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.41|0.8140
71908417|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.09||||0.8331|TWO_SIDED|95.0|0.49|2.4|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.40|0.49|0.8331
71908418|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.51||||0.2682|TWO_SIDED|95.0|0.73|3.12|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.12|0.73|0.2682
71908419|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0001|TWO_SIDED|95.0|1.31|2.29|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.29|1.31|0.0001
71908420|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.49|2.61|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.61|1.49|<.0001
71908421|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0071|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0071
71908422|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1187|TWO_SIDED|95.0|0.95|1.57|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.95|0.1187
71688759|NCT03951753|142892921|OTHER||Slope|-296.1||||0.044|TWO_SIDED|95.0|-584.8|-7.5|||ANCOVA|||||-7.5|-584.8|0.044
71908423|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.39||||0.011|TWO_SIDED|95.0|1.08|1.79|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|1.08|0.0110
71908424|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0003|TWO_SIDED|95.0|1.3|2.39|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.30|0.0003
71908425|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.12|||<|0.0001|TWO_SIDED|95.0|1.57|2.87|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.87|1.57|<.0001
71908426|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0069|TWO_SIDED|95.0|1.11|1.97|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.11|0.0069
71688760|NCT03951753|142892921|OTHER||Least Squares Mean Difference|-637.7|||<|0.001|TWO_SIDED|95.0|-925.2|-350.2|||ANCOVA|||||-350.2|-925.2|<0.001
71908427|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2076|TWO_SIDED|95.0|0.91|1.55|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.91|0.2076
71908428|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.86|1.10|0.0072
71908429|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0694|TWO_SIDED|95.0|0.97|2.22|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.97|0.0694
71908430|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.53|3.36|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||3.36|1.53|<.0001
71908431|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.36||||0.121|TWO_SIDED|95.0|0.92|2.0|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.92|0.1210
71908432|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.08||||0.6706|TWO_SIDED|95.0|0.76|1.54|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.76|0.6706
71908433|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0022|TWO_SIDED|95.0|1.2|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.32|1.20|0.0022
71908434|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.12||||0.7546|TWO_SIDED|95.0|0.56|2.22|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.22|0.56|0.7546
71908435|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7347|TWO_SIDED|95.0|0.57|2.24|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|0.57|0.7347
71862768|NCT00401258|143240269|SUPERIORITY_OR_OTHER|||||||0.004||||||Refers to work/school sub-scale|Mixed Models Analysis|||||||0.004
71862769|NCT00401258|143240269|SUPERIORITY_OR_OTHER|||||||0.087||||||Refers to social sub scale|Mixed Models Analysis|||||||0.087
71862770|NCT00401258|143240269|SUPERIORITY_OR_OTHER|||||||0.006||||||Refers to family sub scale|Mixed Models Analysis|||||||0.006
71862771|NCT05672771|143240281|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.355|TWO_SIDED||||||ANOVA|||||||0.355
71862772|NCT05672771|143240282|SUPERIORITY||Mean Difference (Final Values)|0.56|||<|0.02|TWO_SIDED||||||ANOVA||This is the difference between the Different Mixed and Placebo Control conditions.|||||<.02
71862773|NCT05672771|143240283|OTHER||||||<|0.05||||||for contrasts of DM, DS, and ST groups relative to the PC group.|Mixed Models Analysis|||||||<.05
71862774|NCT00760747|143240284|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|-0.7|STANDARD_ERROR_OF_MEAN|1.7||0.692|TWO_SIDED|95.0|-4.0|2.6|||Mixed Models Analysis|||||2.6|-4.0|0.692
71862775|NCT00760747|143240285|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.456|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.456
71862776|NCT00760747|143240286|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.517|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|||||0.7|-0.3|0.517
71862777|NCT00760747|143240287|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.526|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.526
71862778|NCT00760747|143240288|SUPERIORITY_OR_OTHER||Least square mean differences at week 10|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.898|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||||0.4|-0.4|0.898
71862779|NCT00760747|143240293|SUPERIORITY_OR_OTHER||Least square mean differences at week 2|-0.1|STANDARD_ERROR_OF_MEAN|1.4||0.927|TWO_SIDED|95.0|-2.9|2.6|||Mixed Models Analysis|||||2.6|-2.9|0.927
71862780|NCT00455741|143240335|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||effect of age on estrogen negative feedback ( nadir LH as % of baseline LH)||||0.90
71862781|NCT00455741|143240335|SUPERIORITY||||||<|0.03||||||a priori threshold for significance is p\<0.05|ANOVA|||positive feedback||||<0.03
71862782|NCT00455741|143240336|SUPERIORITY||||||=|0.03||||||a priori significance level p\<0.05|ANOVA|||||||=0.03
71862783|NCT00455741|143240337|SUPERIORITY|||||||0.49||||||threshold for significance p\<0.05|t-test, 2 sided|||||||0.49
71862784|NCT00455741|143240338|SUPERIORITY||||||<|0.02||||||a priori threshold for significance p\<0.05|t-test, 2 sided|||||||<0.02
71862785|NCT00455741|143240339|SUPERIORITY||||||<|0.03|||||||t-test, 2 sided|||||||<0.03
71862786|NCT00455741|143240340|SUPERIORITY|||||||0.07||||||a priori significance set at p\<0.05|t-test, 2 sided|||||||0.07
71862787|NCT00935532|143240384|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (\<8.5%, \>=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.|Least Squares Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.59|-0.26||No adjustments for multiplicity will be performed|ANCOVA|||The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).||-0.26|-0.59|<.001
71862788|NCT00935532|143240385|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
71862789|NCT00935532|143240386|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c\<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.||||<.001
71862790|NCT00935532|143240387|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.28|STANDARD_ERROR_OF_MEAN|3.23||0.103|TWO_SIDED|95.0|-11.62|1.07|||ANCOVA|||Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.||1.07|-11.62|0.103
71862791|NCT00935532|143240388|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.46|-1.56|||ANCOVA|||Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.||-1.56|-2.46|<.001
71862792|NCT00935532|143240389|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.89|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-12.33|-3.45|||ANCOVA|||Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.||-3.45|-12.33|<.001
71862793|NCT00935532|143240390|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.69||0.689|TWO_SIDED|95.0|-1.64|1.09|||ANCOVA|||Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.||1.09|-1.64|0.689
71862794|NCT00935532|143240391|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|1.03||0.99|TWO_SIDED|95.0|0.94|1.06|||ANCOVA|||Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.||1.06|0.94|0.990
71688761|NCT03951753|142892921|OTHER||Least Squares Mean Difference|-341.6||||0.006|TWO_SIDED|95.0|-585.2|-97.9|||ANCOVA|||||-97.9|-585.2|0.006
71908436|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.96||||0.9029|TWO_SIDED|95.0|0.5|1.84|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.84|0.50|0.9029
71688762|NCT03951753|142892922|OTHER||Least Squares Mean Difference|-245.5|||<|0.001|TWO_SIDED|95.0|-357.7|-133.3|||Mixed Models Analysis|||||-133.3|-357.7|<0.001
71908437|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6402|TWO_SIDED|95.0|0.62|2.18|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.18|0.62|0.6402
71908438|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.17||||0.6199|TWO_SIDED|95.0|0.62|2.2|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.20|0.62|0.6199
71908439|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0229|TWO_SIDED|95.0|1.05|1.83|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.05|0.0229
71908440|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.73||||0.0002|TWO_SIDED|95.0|1.3|2.3|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.30|1.30|0.0002
71908441|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.14||||0.315|TWO_SIDED|95.0|0.88|1.47|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.47|0.88|0.3150
71908442|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.21||||0.137|TWO_SIDED|95.0|0.94|1.57|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.57|0.94|0.1370
71908443|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0018|TWO_SIDED|95.0|1.17|1.97|||Regression, Logistic|||Week 12, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.97|1.17|0.0018
71908444|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0342|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.81|1.02|0.0342
71908445|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.69||||0.0003|TWO_SIDED|95.0|1.27|2.24|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.24|1.27|0.0003
71908446|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2561|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2561
71908447|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2358|TWO_SIDED|95.0|0.9|1.51|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.90|0.2358
71908448|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.45||||0.004|TWO_SIDED|95.0|1.13|1.87|||Regression, Logistic|||Week 12, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.87|1.13|0.0040
71908449|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0723|TWO_SIDED|95.0|0.97|2.02|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.97|0.0723
71908450|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.45|2.92|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|1.45|<.0001
71908451|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0653|TWO_SIDED|95.0|0.98|1.94|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.94|0.98|0.0653
71908452|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9177|TWO_SIDED|95.0|0.74|1.4|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.40|0.74|0.9177
71908453|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0088|TWO_SIDED|95.0|1.11|2.01|||Regression, Logistic|||Week 12, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.01|1.11|0.0088
71908454|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1197|TWO_SIDED|95.0|0.89|2.83|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.83|0.89|0.1197
71908455|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0913|TWO_SIDED|95.0|0.92|2.92|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.92|0.92|0.0913
71908456|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4317|TWO_SIDED|95.0|0.72|2.19|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.19|0.72|0.4317
71908457|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.27||||0.3498|TWO_SIDED|95.0|0.77|2.08|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.08|0.77|0.3498
71681682|NCT01606202|142881625|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.05||||0.86|TWO_SIDED|95.0|-0.54|0.65|||ANCOVA|||The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.||0.65|-0.54|0.860
71688763|NCT03951753|142892922|OTHER||Least Squares Mean Difference|-309.8|||<|0.001|TWO_SIDED|95.0|-423.0|-196.6|||Mixed Models Analysis|||||-196.6|-423.0|<0.001
71688764|NCT03951753|142892922|OTHER||Least Squares Mean Difference|-64.3||||0.187|TWO_SIDED|95.0|-160.3|31.7|||Mixed Models Analysis|||||31.7|-160.3|0.187
71908458|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.31||||0.2768|TWO_SIDED|95.0|0.8|2.15|||Regression, Logistic|||Week 12, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.15|0.80|0.2768
71908459|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.92|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.92|1.09|0.0101
71908460|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0054|TWO_SIDED|95.0|1.13|1.99|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.99|1.13|0.0054
71908461|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5493|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.39|0.84|0.5493
71908462|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0269|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.74|1.03|0.0269
71908463|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.80|1.07|0.0144
71908464|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0846|TWO_SIDED|95.0|0.97|1.7|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.97|0.0846
71908465|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0101|TWO_SIDED|95.0|1.09|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.91|1.09|0.0101
71908466|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0848|TWO_SIDED|95.0|0.97|1.62|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.97|0.0848
71908467|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.02||||0.8732|TWO_SIDED|95.0|0.79|1.32|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.32|0.79|0.8732
71908468|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2734|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.89|0.2734
71908469|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2839|TWO_SIDED|95.0|0.86|1.7|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|0.86|0.2839
71908470|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0238|TWO_SIDED|95.0|1.05|2.07|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.07|1.05|0.0238
71908471|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5212|TWO_SIDED|95.0|0.81|1.53|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.81|0.5212
71908472|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5954|TWO_SIDED|95.0|0.8|1.48|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.80|0.5954
71908473|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0638|TWO_SIDED|95.0|0.98|1.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.79|0.98|0.0638
71908474|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2661|TWO_SIDED|95.0|0.78|2.44|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.44|0.78|0.2661
71908475|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.24||||0.4717|TWO_SIDED|95.0|0.69|2.21|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.21|0.69|0.4717
71908476|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5798|TWO_SIDED|95.0|0.68|2.0|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.00|0.68|0.5798
71908477|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5027|TWO_SIDED|95.0|0.72|1.95|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.95|0.72|0.5027
71862795|NCT04954326|143240395|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for AUCinf should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|102.8||||0.05|TWO_SIDED|90.0|91.4|115.6|||ANOVA|||AUCinf was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||115.6|91.4|0.05
71862796|NCT04954326|143240396|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cmax should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|93.5||||0.05|TWO_SIDED|90.0|82.9|105.5|||ANOVA|||Cmax was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||105.5|82.9|0.05
71862797|NCT04954326|143240397|EQUIVALENCE|The 90% Confidence Interval of the geometric mean ratios of the Lyophilisate compared to the Liquid formulations for Cday14 should be completely contained within the predefined \[80.00%-125.00%\] equivalence interval.|Geometric Mean Ratio (%)|121.5||||0.05|TWO_SIDED|90.0|98.7|149.6|||ANOVA|||Cday14 was natural log-transformed and analyzed using an analysis of variance (ANOVA) with fixed effect for formulation. The two one-sided tests procedures were performed on the geometric mean ratio (GMR) between test (S95014 lyophilizate) and reference (S95014 liquid formulation) treatments. The 90% confidence interval for the ratio was obtained within the framework of the ANOVA.||149.6|98.7|0.05
71862798|NCT04982575|143240400|OTHER||Treatment difference|-0.3||||0.2284|TWO_SIDED|95.0|-0.79|0.19|||Mixed Models Analysis|||The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification.||0.19|-0.79|0.2284
71862799|NCT01151423|143240410|SUPERIORITY||Hazard Ratio (HR)|2.2|||=|0.005|TWO_SIDED|95.0|1.28|3.78||Caplacizumab was compared to placebo using a one-sided log-rank test in order to assess superiority at 2.5% significance level.|Stratified log-rank test||The HR was estimated from a Cox proportional Hazards regression model with presence (yes) / absence (no) of 1 PE session prior to randomization as covariate.|The primary analysis consisted of a Kaplan-Meier analysis with time-to-response as endpoint and treatment group as the independent variable and stratified for absence/presence of one PE session prior to randomization.||3.78|1.28|= 0.005
71862800|NCT00475228|143240431|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71862801|NCT03931746|143240435|SUPERIORITY||Hodges-Lehmann median difference|-3.5||||0.04|TWO_SIDED|95.0|-8.0|-0.5|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||-0.5|-8.0|0.04
71862802|NCT03931746|143240436|SUPERIORITY||Hodges-Lehmann median difference|-2.5||||0.75|TWO_SIDED|95.0|-9.0|12.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft minus No Porcine Xenograft.|||12|-9|0.75
71862803|NCT03931746|143240437|SUPERIORITY||Hodges-Lehmann median difference|1.0||||1|TWO_SIDED|95.0|-19.0|20.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||20.0|-19.0|1
71862804|NCT03931746|143240438|SUPERIORITY||Hodges-Lehmann median difference|0.01||||1|TWO_SIDED|95.0|-0.26|0.33|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft vs. No Porcine Xenograft.|||0.33|-0.26|1
71862805|NCT03931746|143240439|SUPERIORITY||Hodges-Lehmann median difference|0.0||||1|TWO_SIDED|95.0|-6.0|4.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||4|-6|1
71862806|NCT03931746|143240440|SUPERIORITY||Hodges-Lehmann median difference|0.5||||0.54|TWO_SIDED|95.0|-1.0|2.0|||Wilcoxon (Mann-Whitney)|An exact Wilcoxon two-sample test was performed owing to the small sample size and number of tied observations.|Median difference is for Porcine Xenograft group minus No Porcine Xenograft group.|||2|-1|0.54
71862807|NCT03931746|143240441|SUPERIORITY||Odds Ratio (OR)|0.69||||1|TWO_SIDED|95.0|0.03|13.3|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||13.3|0.03|1
71862808|NCT03931746|143240442|SUPERIORITY||Risk Difference (RD)|-0.167||||0.43|TWO_SIDED|95.0|-0.564|0.185|||Fisher Exact||"The risk difference is calculated as the outcome risk in the Porcine Xenograft group minus the outcome risk in the No Porcine Xenograft group. The confidence interval for the risk difference was calculated using the Newcombe hybrid score method."|||0.185|-0.564|0.43
71862809|NCT03931746|143240443|SUPERIORITY||Odds Ratio (OR)|0.6||||1|TWO_SIDED|95.0|0.006|55.9|||Fisher Exact||"The No Porcine Xenograft group is the reference group."|||55.9|0.006|1
71681683|NCT01606202|142881626|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.64||||0.873|TWO_SIDED|95.0|-8.56|7.27|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.||7.27|-8.56|0.873
71862810|NCT02473965|143240450|SUPERIORITY||Odds Ratio (OR)|0.868|||=|1|TWO_SIDED|95.0|0.27|2.787||The statistical inference was tested as 2-sided with alpha=0.05.|Fisher Exact|||An unstratified analysis using Fisher's exact test was used for treatment comparison without adjustment for stratified baseline prednisone equivalent dose level due to the small cell size. The odds ratio and confidence intervals are calculated overall (i.e. all mITT subjects).||2.787|0.270|=1.00
71862811|NCT02473965|143240451|SUPERIORITY||LS mean difference|1.58|STANDARD_ERROR_OF_MEAN|12.536|=|0.9|TWO_SIDED|95.0|-23.52|26.68|||ANCOVA|||Treatment comparison of percent change in daily CS dose from baseline to Week 39. The Analysis of Covariance model included the percent change from baseline in daily CS dose as the dependent variable, treatment as a fixed effect and baseline daily CS dose as covariate.||26.68|-23.52|=0.900
71862812|NCT01183390|143240453|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.6|||||TWO_SIDED|90.0|95.1|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.28|95.10|
71862813|NCT01183390|143240454|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||TWO_SIDED|90.0|96.99|101.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.80|96.99|
71862814|NCT01730950|143240480|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.7|1.38|||Log Rank|Two-side significance level = 0.05|Reference level = Bevacizumab|Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.||1.38|0.70|0.46
71862815|NCT01730950|143240481|SUPERIORITY|||||||0.18|||||||Chi-squared|Two-sided significance level = 0.05||||||0.18
71862816|NCT01730950|143240482|SUPERIORITY|||||||0.001|||||||Chi-squared|Two-sided significance level = 0.05||||||0.001
71862817|NCT01730950|143240483|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.05|TWO_SIDED|95.0|0.53|1.0|||Log Rank|Two-sided significance level = 0.05|Reference level = Bevacizumab|||1.00|0.53|0.05
71862818|NCT00667459|143240486|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.032||||0.995|TWO_SIDED|95.0|-0.07|0.134||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.134|-0.070|0.995
71862819|NCT00667459|143240486|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.||||0.736
71882475|NCT01087905|143284056|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|712.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.||||
71681684|NCT01606202|142881627|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.07||||0.83|TWO_SIDED|95.0|-0.61|0.75|||ANCOVA|||The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.||0.75|-0.61|0.830
71681685|NCT01606202|142881628|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.4||||0.86|TWO_SIDED|95.0|-4.08|4.88|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.||4.88|-4.08|0.860
71681686|NCT01606202|142881629|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.14||||0.142|TWO_SIDED|95.0|-0.33|0.05|||ANCOVA|||The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.||0.05|-0.33|0.142
71681687|NCT01606202|142881630|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.11||||0.824|TWO_SIDED|95.0|-1.13|0.9|||ANCOVA|||The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.||0.90|-1.13|0.824
71681688|NCT01606202|142881631|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-0.04||||0.847|TWO_SIDED|95.0|-0.49|0.4|||ANCOVA|||The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.||0.40|-0.49|0.847
71681689|NCT01606202|142881632|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.29||||0.287|TWO_SIDED|95.0|-3.74|1.16|||ANCOVA|||The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.||1.16|-3.74|0.287
71862820|NCT00667459|143240487|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.048||||1|TWO_SIDED|95.0|-0.02|0.118||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 \> -d \| data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint."||0.118|-0.020|1.0
71862821|NCT00667459|143240487|SUPERIORITY_OR_OTHER_LEGACY|||||||0.912||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.912
71862822|NCT00667459|143240488|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.099||||1|TWO_SIDED|95.0|0.038|0.161||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.161|0.038|1.0
71862823|NCT00667459|143240488|SUPERIORITY_OR_OTHER_LEGACY|||||||0.999||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.999
71862824|NCT00667459|143240489|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.034||||0.992|TWO_SIDED|95.0|-0.085|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.085|0.992
71862825|NCT00667459|143240489|SUPERIORITY_OR_OTHER_LEGACY|||||||0.097||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.097
71681690|NCT01606202|142881633|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|33.86|||<|0.001|TWO_SIDED|95.0|17.07|50.64|||Fisher Exact|||The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.||50.64|17.07|<0.001
71681691|NCT01606202|142881634|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-1.93||||0.032|TWO_SIDED|95.0|-3.69|-0.16|||ANCOVA|||The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.||-0.16|-3.69|0.032
71882476|NCT01087905|143284056|SUPERIORITY_OR_OTHER||Incremental cost-effectiveness ratio|1290.0||||||95.0||||There is no p-value for the incremental cost-effectiveness ratio (ICER).|Incremental cost-effectiveness ratio|Unit of measurement for ICER is U.S. dollars.||In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.||||
71681692|NCT03019003|142881637|OTHER||||||<|0.036|||||||t-test, 2 sided|||||||<0.036
71681693|NCT02124759|142881653|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|Paired T-test||Null hypothesis is that high fat diet will have no effect on M value, the measure of insulin sensitivity for each intervention as assessed by clamp.||||>0.05
71681694|NCT04250298|142881681|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71681695|NCT04250298|142881682|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
71882477|NCT01179009|143284074|SUPERIORITY|||||||0.53||||||The p-value above represents the interaction between the treatment group and time.|ANOVA|||||||0.53
71681696|NCT04250298|142881683|OTHER|||||||0.228|||||||t-test, 2 sided|||||||0.228
71681697|NCT04250298|142881684|OTHER|||||||0.267|||||||t-test, 2 sided|||||||0.267
71681698|NCT04250298|142881685|OTHER||||||>|0.999|||||||Fisher Exact|||||||>0.999
71681699|NCT04250298|142881686|OTHER|||||||0.318|||||||Fisher Exact|||||||0.318
71681700|NCT04250298|142881687|OTHER|||||||0.348|||||||Fisher Exact|||||||0.348
71681701|NCT04250298|142881688|OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.548
71681702|NCT04250298|142881689|OTHER|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
71681703|NCT04250298|142881690|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
71681704|NCT04250298|142881691|OTHER|||||||0.506|||||||Wilcoxon (Mann-Whitney)|||||||0.506
71862826|NCT00667459|143240490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.043|0.023||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.023|-0.043|1.0
71862827|NCT00667459|143240490|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.273
71862828|NCT00667459|143240491|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.019||||1|TWO_SIDED|95.0|-0.018|0.058||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.058|-0.018|1.0
71862829|NCT00667459|143240491|SUPERIORITY_OR_OTHER_LEGACY|||||||0.845||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.845
71862830|NCT00667459|143240492|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.047||||0.936|TWO_SIDED|95.0|-0.113|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.021|-0.113|0.936
71908478|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8165|TWO_SIDED|95.0|0.64|1.77|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.64|0.8165
71908479|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.18||||0.1996|TWO_SIDED|95.0|0.92|1.52|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.52|0.92|0.1996
71908480|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0074|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.83|1.10|0.0074
71908481|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3557|TWO_SIDED|95.0|0.87|1.45|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.45|0.87|0.3557
71908482|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.36||||0.017|TWO_SIDED|95.0|1.06|1.75|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.75|1.06|0.0170
71882478|NCT01179009|143284075|SUPERIORITY|||||||0.06||||||The p-value above comes from a model where the treatment group is used to predict the CGI improvement score.|Ordinal regression|||||||0.06
71882479|NCT02943564|143284100|SUPERIORITY||Least Squares Mean Difference|0.1||||0.8862|TWO_SIDED|95.0|-1.5|1.73|||Mixed Model Repeated Measures (MMRM)|||||1.73|-1.50|0.8862
71882480|NCT02943564|143284100|SUPERIORITY||Least Squares Mean Difference|-0.5||||0.5772|TWO_SIDED|95.0|-2.07|1.16|||Mixed Model Repeated Measures (MMRM)|||||1.16|-2.07|0.5772
71882481|NCT02943564|143284101|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.8967|TWO_SIDED|95.0|-1.48|1.29|||Mixed Model Repeated Measures (MMRM)|||||1.29|-1.48|0.8967
71882482|NCT02943564|143284101|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9963|TWO_SIDED|95.0|-1.38|1.39|||Mixed Model Repeated Measures (MMRM)|||||1.39|-1.38|0.9963
71908483|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8641|TWO_SIDED|95.0|0.76|1.38|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.38|0.76|0.8641
71908484|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1768|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1768
71908485|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7696|TWO_SIDED|95.0|0.55|1.55|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.55|0.7696
71908486|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.09||||0.7433|TWO_SIDED|95.0|0.66|1.78|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.78|0.66|0.7433
71862831|NCT00667459|143240493|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.105||||1|TWO_SIDED|95.0|0.02|0.19||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d \> p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 \> -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."||0.190|0.020|1.0
71882483|NCT01225731|143284108|SUPERIORITY_OR_OTHER||% Difference in Response Rate|28.89||||0.001|TWO_SIDED|95.0|13.41|44.36|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||44.36|13.41|0.001
71882484|NCT01225731|143284108|SUPERIORITY_OR_OTHER||% Difference in Response Rate|60.0|||<|0.001|TWO_SIDED|95.0|48.42|71.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||71.58|48.42|<0.001
71882485|NCT01225731|143284108|SUPERIORITY_OR_OTHER||% Difference in Response Rate|61.85|||<|0.001|TWO_SIDED|95.0|50.33|73.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||73.37|50.33|<0.001
71882486|NCT01225731|143284108|SUPERIORITY_OR_OTHER||% Difference in Response Rate|69.97|||<|0.001|TWO_SIDED|95.0|58.96|80.99|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||80.99|58.96|<0.001
71882487|NCT01225731|143284109|SUPERIORITY_OR_OTHER||% Difference in Response Rate|19.37||||0.009|TWO_SIDED|95.0|5.15|33.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||33.58|5.15|0.009
71882488|NCT01225731|143284109|SUPERIORITY_OR_OTHER||% Difference in Response Rate|54.44|||<|0.001|TWO_SIDED|95.0|42.63|66.26|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.26|42.63|<0.001
71882489|NCT01225731|143284109|SUPERIORITY_OR_OTHER||% Difference in Response Rate|56.23|||<|0.001|TWO_SIDED|95.0|44.43|68.03|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||68.03|44.43|<0.001
71882490|NCT01225731|143284109|SUPERIORITY_OR_OTHER||% Difference in Response Rate|67.65|||<|0.001|TWO_SIDED|95.0|56.42|78.88|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||78.88|56.42|<0.001
71882491|NCT01225731|143284110|SUPERIORITY_OR_OTHER||% Difference in Response Rate|31.11|||<|0.001|TWO_SIDED|95.0|16.22|46.0|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||46.0|16.22|<0.001
71882492|NCT01225731|143284110|SUPERIORITY_OR_OTHER||% Difference in Response Rate|55.56|||<|0.001|TWO_SIDED|95.0|44.48|66.63|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||66.63|44.48|<0.001
71882493|NCT01225731|143284110|SUPERIORITY_OR_OTHER||% Difference in Response Rate|59.58|||<|0.001|TWO_SIDED|95.0|48.6|70.55|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||70.55|48.60|<0.001
71882494|NCT01225731|143284110|SUPERIORITY_OR_OTHER||% Difference in Response Rate|72.2|||<|0.001|TWO_SIDED|95.0|62.02|82.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or \>90 kg) and prior use of biologics for psoriasis (Yes/No).||||82.37|62.02|<0.001
71882495|NCT00577642|143284121|OTHER|single group|||||<|0.05|||||||t-test, 1 sided|||Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.||||<0.05
71882496|NCT01556425|143284122|SUPERIORITY||Odds Ratio (OR)|2.26||||0.48|TWO_SIDED|95.0|0.2|21.6|||General Estimating Equation (GEE)|||||21.6|0.2|0.48
71882497|NCT01556425|143284122|SUPERIORITY||Odds Ratio (OR)|0.58||||0.61|TWO_SIDED|95.0|0.1|4.6|||General Estimating Equation (GEE)|||||4.6|0.1|0.61
71882498|NCT01556425|143284122|SUPERIORITY||Odds Ratio (OR)|6.0||||0.11|TWO_SIDED|95.0|0.7|54.9|||General Estimating Equation (GEE)|||||54.9|0.7|0.11
71882499|NCT01556425|143284122|SUPERIORITY||Odds Ratio (OR)|2.66||||0.39|TWO_SIDED|95.0|0.3|24.9|||General Estimating Equation (GEE)|||||24.9|0.3|0.39
71882500|NCT01556425|143284122|SUPERIORITY||Odds Ratio (OR)|10.4||||0.03|TWO_SIDED|95.0|1.3|85.5|||General Estimating Equation (GEE)|||||85.5|1.3|0.03
71882501|NCT01556425|143284123|SUPERIORITY||Odds Ratio (OR)|0.36||||0.3|TWO_SIDED|95.0|0.1|2.4|||General Estimating Equation (GEE)|||||2.4|0.1|0.30
71882502|NCT01556425|143284123|SUPERIORITY||Odds Ratio (OR)|0.2||||0.08|TWO_SIDED|95.0|0.03|1.2|||General Estimating Equation (GEE)|||||1.2|0.03|0.08
71882503|NCT01556425|143284123|SUPERIORITY||Odds Ratio (OR)|0.91||||0.91|TWO_SIDED|95.0|0.1|5.8|||General Estimating Equation (GEE)|||||5.8|0.1|0.91
71882504|NCT01556425|143284123|SUPERIORITY||Odds Ratio (OR)|2.47||||0.34|TWO_SIDED|95.0|0.4|15.8|||General Estimating Equation (GEE)|||||15.8|0.4|0.34
71882505|NCT01556425|143284123|SUPERIORITY||Odds Ratio (OR)|4.46||||0.09|TWO_SIDED|95.0|0.8|26.1|||General Estimating Equation (GEE)|||||26.1|0.8|0.09
71882506|NCT01505634|143284124|NON_INFERIORITY|Non-inferiority for the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-3.1||||0.005|TWO_SIDED|95.0|-11.2|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Difference (Diff) in Favorable MR||3.2|-11.2|0.005
71882507|NCT01505634|143284124|NON_INFERIORITY|Non-inferiority for the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-0.1|||<|0.001|TWO_SIDED|95.0|-6.4|5.9|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Favorable MR||5.9|-6.4|< 0.001
71862832|NCT00667459|143240493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992||95.0||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.||||0.992
71862833|NCT00667459|143240495|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the operative time in two treatment groups was assessed.||||0.013
71862834|NCT00667459|143240496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.769||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the blood loss in two treatment groups was assessed.||||0.769
71862835|NCT00667459|143240497|SUPERIORITY_OR_OTHER_LEGACY|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the hospital stay in two treatment groups was assessed.||||0.273
71908487|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0562|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0562
71908488|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0274|TWO_SIDED|95.0|1.03|1.71|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|1.03|0.0274
71908489|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1206|TWO_SIDED|95.0|0.95|1.58|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.95|0.1206
71908490|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0365|TWO_SIDED|95.0|1.02|1.69|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.69|1.02|0.0365
71908491|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0964|TWO_SIDED|95.0|0.96|1.71|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.96|0.0964
71862836|NCT04546217|143240513|SUPERIORITY|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
71862837|NCT04546217|143240514|OTHER|Since this is a descriptive analysis, no power calculation was conducted.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
71882508|NCT01505634|143284125|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with Event of Clinical Interest (ECI) #1||5.5|-2.7|0.315
71862838|NCT04546217|143240515|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.||||||||||||||||Considering the small sample size, a descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits.|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
71862839|NCT04546217|143240516|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
71862840|NCT04546217|143240517|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
71862841|NCT04546217|143240518|OTHER|A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessments visits. Changes in scores post-treatment vs. pre-treatment, and 3 and 6-month follow up vs. post-treatment were calculated.|||||||||||||||||A descriptive analysis of means and standard deviations was conducted comparing scores obtained on pre-, post-treatment, at the 3- and 6-month follow up assessment visits. Changes in the scores obtained on all time points compared to pre-treatment were also identified.|||
71862842|NCT01888874|143240541|SUPERIORITY||Difference in percentage rates|11.9||||0.1236|TWO_SIDED|95.0|-3.1|26.9|||Regression, Logistic|P-value has been corrected for multiplicity according to Hommel's closed-testing method.||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||26.9|-3.1|0.1236
71862843|NCT01888874|143240541|SUPERIORITY||Difference in percentage rates|19.3||||0.0435|TWO_SIDED|95.0|4.7|34.0||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||34|4.7|0.0435
71862844|NCT01888874|143240541|SUPERIORITY||Difference in percentage rates|24.4||||0.0068|TWO_SIDED|95.0|10.1|38.8||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||38.8|10.1|0.0068
71862845|NCT01888874|143240541|SUPERIORITY||Difference in percentage rates|12.8||||0.1236|TWO_SIDED|95.0|-2.0|27.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||27.6|-2|0.1236
71862846|NCT01888874|143240541|SUPERIORITY||Difference in percentage rates|15.8||||0.1056|TWO_SIDED|95.0|1.0|30.6||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||30.6|1|0.1056
71862847|NCT01888874|143240541|SUPERIORITY||Difference in percentage rates|34.4|||<|0.0001|TWO_SIDED|95.0|20.7|48.1||P-value has been corrected for multiplicity according to Hommel's closed-testing method.|Regression, Logistic|||Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.||48.1|20.7|< 0.0001
71862848|NCT02980042|143240553|SUPERIORITY||Risk Ratio (RR)|0.6616||||0.1996|TWO_SIDED|95.0|0.3666|1.1942|||Generalized estimating equations|GEE was necessary because there are repeated measures on subjects.|This is comparing the Switching group to the Comparator group|||1.1942|.3666|0.1996
71862849|NCT02980042|143240554|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.5299|1.8872|||Generalized estimating equations|GEE was used because there are repeated measures on subjects|Comparing Switching group Day 1 to combined Comparator group|||1.8872|.5299|1.0000
71862850|NCT02980042|143240554|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0053|TWO_SIDED|95.0|0.1006|0.8114|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|Switching group Day 15 was compared to combined Comparator group.|||.8114|.1006|0.0053
71862851|NCT02980042|143240554|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.6474|TWO_SIDED|95.0|0.4385|1.6753|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.6753|.4385|0.6474
71862852|NCT02980042|143240558|SUPERIORITY||Risk Ratio (RR)|0.2857||||0.0075|TWO_SIDED|95.0|0.1072|0.7613|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||.7613|.1072|0.0075
71862853|NCT02980042|143240558|SUPERIORITY||Risk Ratio (RR)|0.8571||||0.593|TWO_SIDED|95.0|0.4868|1.5093|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||1.5093|.4868|0.5930
71862854|NCT02980042|143240558|SUPERIORITY||Risk Ratio (RR)|3.0||||0.0209|TWO_SIDED|95.0|1.126|7.9932|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.||||7.9932|1.1260|0.0209
71862855|NCT02980042|143240563|OTHER||Mean Difference (Net)|0.0||||0.005|TWO_SIDED|95.0|-27.05|-5.01||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.01|-27.05|0.005
71908492|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.19||||0.2515|TWO_SIDED|95.0|0.89|1.59|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.89|0.2515
71908493|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.06||||0.8122|TWO_SIDED|95.0|0.66|1.71|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.71|0.66|0.8122
71908494|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.36||||0.1848|TWO_SIDED|95.0|0.86|2.13|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.13|0.86|0.1848
71908495|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2622|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2622
71908496|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1579|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.54|0.93|0.1579
71908497|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2773|TWO_SIDED|95.0|0.89|1.49|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.89|0.2773
71908498|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1032|TWO_SIDED|95.0|0.96|1.59|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.59|0.96|0.1032
71908499|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4418|TWO_SIDED|95.0|0.84|1.5|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.50|0.84|0.4418
71908500|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1608|TWO_SIDED|95.0|0.92|1.63|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.63|0.92|0.1608
71908501|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.29||||0.2628|TWO_SIDED|95.0|0.83|2.02|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.02|0.83|0.2628
71908502|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0447|TWO_SIDED|95.0|1.01|2.39|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.39|1.01|0.0447
71908503|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.16||||0.256|TWO_SIDED|95.0|0.9|1.49|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.49|0.90|0.2560
71908504|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1741|TWO_SIDED|95.0|0.93|1.53|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.53|0.93|0.1741
71908505|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1647|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.55|0.93|0.1647
71908506|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0619|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.65|0.99|0.0619
71908507|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2025|TWO_SIDED|95.0|0.9|1.61|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.61|0.90|0.2025
71908508|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2601|TWO_SIDED|95.0|0.88|1.58|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.88|0.2601
71908509|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.14||||0.5635|TWO_SIDED|95.0|0.73|1.77|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.77|0.73|0.5635
71908510|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.38||||0.1338|TWO_SIDED|95.0|0.91|2.11|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||2.11|0.91|0.1338
71862856|NCT02980042|143240564|OTHER||Mean Difference (Net)|2.55|||<|0.0001|TWO_SIDED|95.0|1.54|3.56||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||3.56|1.54|<0.0001
71862857|NCT02980042|143240565|OTHER||Median Difference (Net)|8.58|||<|0.0001|TWO_SIDED|95.0|6.33|10.82||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||10.82|6.33|<0.0001
71862858|NCT02980042|143240566|OTHER||Mean Difference (Net)|-7.37|||<|0.0001|TWO_SIDED|95.0|-10.19|-4.55||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.55|-10.19|<0.0001
71862859|NCT02980042|143240567|OTHER||Mean Difference (Net)|44.32|||<|0.0001|TWO_SIDED|95.0|29.59|59.05||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||59.05|29.59|<0.0001
71862860|NCT02980042|143240568|OTHER||Mean Difference (Net)|353.35||||0.0002|TWO_SIDED|95.0|175.23|531.46||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||531.46|175.23|0.0002
71908511|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2137|TWO_SIDED|95.0|0.91|1.51|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.51|0.91|0.2137
71908512|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0256|TWO_SIDED|95.0|1.04|1.72|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|1.04|0.0256
71908513|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3531|TWO_SIDED|95.0|0.87|1.46|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.46|0.87|0.3531
71908514|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0358|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.70|1.02|0.0358
71908515|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.22||||0.184|TWO_SIDED|95.0|0.91|1.62|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.62|0.91|0.1840
71908516|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.25||||0.125|TWO_SIDED|95.0|0.94|1.67|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.67|0.94|0.1250
71908517|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8266|TWO_SIDED|95.0|0.61|1.48|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.48|0.61|0.8266
71908518|NCT02528253|143339056|SUPERIORITY||Odds Ratio (OR)|1.13||||0.5673|TWO_SIDED|95.0|0.74|1.72|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.72|0.74|0.5673
71908519|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0076|TWO_SIDED|95.0|1.12|2.08|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.08|1.12|0.0076
71908520|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.98|||<|0.0001|TWO_SIDED|95.0|1.46|2.69|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.69|1.46|<.0001
71908521|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.31||||0.07|TWO_SIDED|95.0|0.98|1.74|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|0.98|0.0700
71908522|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.17||||0.2655|TWO_SIDED|95.0|0.89|1.54|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.89|0.2655
71908523|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0022|TWO_SIDED|95.0|1.16|1.98|||Regression, Logistic|||Week 2, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.98|1.16|0.0022
71908524|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0125|TWO_SIDED|95.0|1.11|2.35|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.11|0.0125
71908525|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0032|TWO_SIDED|95.0|1.21|2.54|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.21|0.0032
71908526|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.3||||0.1528|TWO_SIDED|95.0|0.91|1.85|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|0.91|0.1528
71908527|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1863|TWO_SIDED|95.0|0.9|1.72|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|0.90|0.1863
71681705|NCT04250298|142881697|OTHER|Mann-Whitney U test, Fisher Exact, Chi-Squared, Kolmogorv-Smirnow||||||0.919|||||||Wilcoxon (Mann-Whitney)|||"sub-population 1 vs. sub-population 2: Parametric and nonparametric univariate tests: t-test for independent samples, Mann-Whitney-U test, Fisher's exact test, chi-square homogeneity test; normal distribution check by Kolmogorov-Smirnov test with Lilliefors -significance correction, type I error = 10%).~Estimate the true effect size:~Two-sided 95% confidence intervals (depending on the nature of the data sets: parametric, non-parametric or Clopper-Pearson) are calculated for all parameters."||||0.919
71681706|NCT04250298|142881699|OTHER|||||||0.033|||||||t-test, 2 sided|||||||0.033
71681707|NCT04250298|142881700|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
71681708|NCT04250298|142881701|OTHER|||||||0.676|||||||t-test, 2 sided|||||||0.676
71681709|NCT04250298|142881702|OTHER|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71681710|NCT04250298|142881707|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71681711|NCT04250298|142881708|OTHER|||||||0.862|||||||t-test, 2 sided|||||||0.862
71681712|NCT04250298|142881709|OTHER|||||||0.25|||||||Fisher Exact|||||||0.250
71681713|NCT04250298|142881710|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71681714|NCT04250298|142881711|OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
71681715|NCT04250298|142881712|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
71681716|NCT04250298|142881713|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
71681717|NCT04250298|142881714|OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
71681718|NCT04250298|142881717|OTHER|||||||0.111|||||||Wilcoxon (Mann-Whitney)|||||||0.111
71681719|NCT04250298|142881718|OTHER|||||||0.213|||||||Wilcoxon (Mann-Whitney)|||||||0.213
71681720|NCT02923245|142881744|OTHER||Mean Difference (Final Values)|49.7|||||TWO_SIDED|95.0|23.4|77.2|||||These confidence intervals correspond to the bootstrap analysis|||77.2|23.4|
71862861|NCT02980042|143240569|OTHER||Mean Difference (Net)|176.9|||<|0.0001|TWO_SIDED|95.0|124.5|229.31||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||229.31|124.50|<0.0001
71908528|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0667|TWO_SIDED|95.0|0.98|1.86|||Regression, Logistic|||Week 2, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|0.98|0.0667
71681721|NCT02923245|142881745|OTHER||Difference in percentages|15.3||||0.006|TWO_SIDED|95.0|5.3|25.0|||Test of proportions|||||25.0|5.3|0.006
71862862|NCT02980042|143240570|OTHER||Mean Difference (Net)|0.19||||0.002|TWO_SIDED|95.0|0.07|0.32||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.32|0.07|0.0020
71862863|NCT02980042|143240571|OTHER||Mean Difference (Net)|0.55|||<|0.0001|TWO_SIDED|95.0|0.32|0.77||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.77|0.32|<0.0001
71862864|NCT02980042|143240572|OTHER||Mean Difference (Net)|-46.16||||0.0091|TWO_SIDED|95.0|-80.61|-11.72||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-11.72|-80.61|0.0091
71862865|NCT02980042|143240573|OTHER||Mean Difference (Net)|55.26||||0.0002|TWO_SIDED|95.0|27.0|83.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||83.52|27.00|0.0002
71862866|NCT02980042|143240574|OTHER||Mean Difference (Net)|-17.24||||0.0044|TWO_SIDED|95.0|-28.96|-5.51||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.51|-28.96|0.0044
71862867|NCT02980042|143240575|OTHER||Mean Difference (Net)|16.01|||<|0.0001|TWO_SIDED|95.0|9.75|22.28||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||22.28|9.75|<0.0001
71862868|NCT02980042|143240576|OTHER||Mean Difference (Net)|429.08|||<|0.0001|TWO_SIDED|95.0|296.07|562.1||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||562.10|296.07|<0.0001
71862869|NCT02980042|143240577|OTHER||Mean Difference (Net)|1.23||||0.0101|TWO_SIDED|95.0|0.3|2.16||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.16|0.30|0.0101
71862870|NCT02980042|143240578|OTHER||Mean Difference (Net)|8.69|||<|0.0001|TWO_SIDED|95.0|4.87|12.52||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||12.52|4.87|<0.0001
71862871|NCT02980042|143240579|OTHER||Mean Difference (Net)|1.53|||<|0.0001|TWO_SIDED|95.0|1.04|2.03||Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 1 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 99.|Mean of post minus pre.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.03|1.04|<0.0001
71862872|NCT02980042|143240580|OTHER||Mean Difference (Net)|-33.17|||<|0.0001|TWO_SIDED|95.0|-38.91|-27.44||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-27.44|-38.91|<0.0001
71908529|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0101|TWO_SIDED|95.0|1.18|3.39|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.39|1.18|0.0101
71908530|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.91||||0.0162|TWO_SIDED|95.0|1.13|3.25|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.13|0.0162
71908531|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.17||||0.5599|TWO_SIDED|95.0|0.69|1.99|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|0.69|0.5599
71681722|NCT00793624|142881776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.193|0.110|<0.0001
71908532|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.71||||0.0202|TWO_SIDED|95.0|1.09|2.68|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.68|1.09|0.0202
71908533|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0335|TWO_SIDED|95.0|1.04|2.57|||Regression, Logistic|||Week 2, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.57|1.04|0.0335
71908534|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.53||||0.0416|TWO_SIDED|95.0|1.04|6.17|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||6.17|1.04|0.0416
71908535|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0075|TWO_SIDED|95.0|1.37|7.69|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||7.69|1.37|0.0075
71908536|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.33||||0.5374|TWO_SIDED|95.0|0.53|3.34|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.34|0.53|0.5374
71908537|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.89||||0.082|TWO_SIDED|95.0|0.92|3.89|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.89|0.92|0.0820
71908538|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.43||||0.0108|TWO_SIDED|95.0|1.23|4.81|||Regression, Logistic|||Week 2, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.81|1.23|0.0108
71908539|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.65||||0.0006|TWO_SIDED|95.0|1.24|2.2|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.24|0.0006
71908540|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.47|2.59|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.59|1.47|<.0001
71908541|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.25||||0.0963|TWO_SIDED|95.0|0.96|1.63|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.63|0.96|0.0963
71908542|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0332|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0332
71908543|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0007|TWO_SIDED|95.0|1.21|2.01|||Regression, Logistic|||Week 4, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.01|1.21|0.0007
71908544|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0001|TWO_SIDED|95.0|1.37|2.64|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.64|1.37|0.0001
71908545|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.6|3.05|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.05|1.60|<.0001
71908546|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0235|TWO_SIDED|95.0|1.05|1.95|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.05|0.0235
71908547|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0459|TWO_SIDED|95.0|1.01|1.76|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.76|1.01|0.0459
71908548|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.54||||0.002|TWO_SIDED|95.0|1.17|2.04|||Regression, Logistic|||Week 4, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.04|1.17|0.0020
71908549|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.93||||0.0019|TWO_SIDED|95.0|1.27|2.91|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.91|1.27|0.0019
71908550|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.42|||<|0.0001|TWO_SIDED|95.0|1.62|3.62|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.62|1.62|<.0001
71908551|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6765|TWO_SIDED|95.0|0.72|1.65|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.72|0.6765
71908552|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.23|2.54|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.54|1.23|0.0022
71908553|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.56|3.15|||Regression, Logistic|||Week 4, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.15|1.56|<.0001
71908554|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.98||||0.027|TWO_SIDED|95.0|1.08|3.63|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.63|1.08|0.0270
71908555|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.43||||0.003|TWO_SIDED|95.0|1.35|4.38|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.38|1.35|0.0030
71908556|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|0.74||||0.377|TWO_SIDED|95.0|0.38|1.44|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.44|0.38|0.3770
71681723|NCT00793624|142881776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.124|<0.0001
71908557|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.68||||0.0009|TWO_SIDED|95.0|1.49|4.79|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.79|1.49|0.0009
71908558|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|3.29|||<|0.0001|TWO_SIDED|95.0|1.87|5.78|||Regression, Logistic|||Week 4, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.78|1.87|<.0001
71908559|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0011|TWO_SIDED|95.0|1.2|2.1|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.10|1.20|0.0011
71908560|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.87|||<|0.0001|TWO_SIDED|95.0|1.41|2.47|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.41|<.0001
71908561|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.33||||0.0273|TWO_SIDED|95.0|1.03|1.72|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.72|1.03|0.0273
71908562|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1736|TWO_SIDED|95.0|0.93|1.54|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.54|0.93|0.1736
71681724|NCT00793624|142881776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.136|<0.0001
71681725|NCT00793624|142881777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.037|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|0.037|0.0002
71908563|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.4||||0.0092|TWO_SIDED|95.0|1.09|1.81|||Regression, Logistic|||Week 8, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.09|0.0092
71908564|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0015|TWO_SIDED|95.0|1.2|2.2|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.20|0.0015
71908565|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.95|||<|0.0001|TWO_SIDED|95.0|1.45|2.63|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.63|1.45|<.0001
71908566|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0164|TWO_SIDED|95.0|1.06|1.86|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.06|0.0164
71908567|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2857|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.51|0.89|0.2857
71908568|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0149|TWO_SIDED|95.0|1.07|1.8|||Regression, Logistic|||Week 8, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.80|1.07|0.0149
71908569|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0001|TWO_SIDED|95.0|1.43|3.02|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.02|1.43|0.0001
71908570|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.57|3.28|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.28|1.57|<.0001
71908571|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.34||||0.118|TWO_SIDED|95.0|0.93|1.92|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.92|0.93|0.1180
71908572|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0062|TWO_SIDED|95.0|1.13|2.14|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.14|1.13|0.0062
71908573|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0009|TWO_SIDED|95.0|1.24|2.32|||Regression, Logistic|||Week 8, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.24|0.0009
71681726|NCT00793624|142881777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.044|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.125|0.044|<0.0001
71862873|NCT02980042|143240581|OTHER||Mean Difference (Net)|-0.62||||0.0008|TWO_SIDED|95.0|-0.98|-0.26||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.26|-0.98|0.0008
71862874|NCT02980042|143240582|OTHER||Mean Difference (Net)|2.01|||<|0.0001|TWO_SIDED|95.0|1.23|2.79||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||2.79|1.23|<0.0001
71862875|NCT02980042|143240583|OTHER||Mean Difference (Net)|-7.84|||<|0.0001|TWO_SIDED|95.0|-9.87|-5.81||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.81|-9.87|<0.0001
71862876|NCT02980042|143240584|OTHER||Mean Difference (Net)|-14.2||||0.0022|TWO_SIDED|95.0|-23.15|-5.25||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-5.25|-23.15|0.0022
71862877|NCT02980042|143240585|OTHER||Mean Difference (Net)|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.43||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.43|0.17|<0.0001
71862878|NCT02980042|143240586|OTHER||Mean Difference (Net)|0.41|||<|0.0001|TWO_SIDED|95.0|0.22|0.61||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||0.61|0.22|<0.0001
71862879|NCT02980042|143240587|OTHER||Mean Difference (Net)|-0.72|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.5||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.50|-0.95|<0.0001
71862880|NCT02980042|143240588|OTHER||Mean Difference (Net)|-19.31|||<|0.0001|TWO_SIDED|95.0|-22.64|-15.98||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-15.98|-22.64|<0.0001
71908574|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.69||||0.0003|TWO_SIDED|95.0|1.56|4.61|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||4.61|1.56|0.0003
71908575|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|3.1|||<|0.0001|TWO_SIDED|95.0|1.82|5.28|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||5.28|1.82|<.0001
71862881|NCT02980042|143240589|OTHER||Mean Difference (Net)|-6.96|||<|0.0001|TWO_SIDED|95.0|-9.85|-4.08||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.08|-9.85|<0.0001
71862882|NCT02980042|143240590|OTHER||Mean Difference (Net)|-23.22||||0.0061|TWO_SIDED|95.0|-39.66|-6.78||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-6.78|-39.66|0.0061
71862883|NCT02980042|143240591|OTHER||Mean Difference (Net)|-5.69|||<|0.0001|TWO_SIDED|95.0|-7.24|-4.14||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-4.14|-7.24|<0.0001
71908576|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.33||||0.312|TWO_SIDED|95.0|0.76|2.32|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|0.76|0.3120
71908577|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0019|TWO_SIDED|95.0|1.3|3.14|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.14|1.30|0.0019
71908578|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0001|TWO_SIDED|95.0|1.52|3.59|||Regression, Logistic|||Week 8, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.59|1.52|0.0001
71908579|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0064|TWO_SIDED|95.0|1.12|1.95|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.95|1.12|0.0064
71681727|NCT00793624|142881777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.021||0.0088||95.0|0.014|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.095|0.014|0.0088
71681728|NCT00793624|142881778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.343||0.5843||95.0|-0.485|0.86|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.860|-0.485|0.5843
71681729|NCT00793624|142881778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.345||0.9494||95.0|-0.656|0.699|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.699|-0.656|0.9494
71681730|NCT00793624|142881778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.288|STANDARD_ERROR_OF_MEAN|0.346||0.5099||95.0|-0.908|0.451|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.451|-0.908|0.5099
71681731|NCT00793624|142881779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.442|STANDARD_ERROR_OF_MEAN|1.401||0.0816||95.0|-5.19|0.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.307|-5.190|0.0816
71681732|NCT00793624|142881779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.394|STANDARD_ERROR_OF_MEAN|1.4||0.0155||95.0|-6.141|-0.648|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.648|-6.141|0.0155
71862884|NCT02980042|143240592|OTHER||Mean Difference (Net)|-0.84||||0.0077|TWO_SIDED|95.0|-1.45|-0.23||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.23|-1.45|0.0077
71862885|NCT02980042|143240593|OTHER||Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.27||99 patients with non-missing change scores used. Controlled for the false discovery rate (alpha = 0.05) for all cytokines on day 15 using the Benjamini-Hochberg procedure.|t-test, 2 sided|Paired T-test. Degrees of freedom = 98.|Mean of post minus pre. 99 usable change scores.|Paired T-test for change in means. Null hypothesis: no pre-post difference.||-0.27|-0.37|<0.0001
71862886|NCT00725270|143240597|SUPERIORITY_OR_OTHER|||||||0.812|||||||Mixed Models Analysis|||Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication \* time interaction.||||.812
71862887|NCT00725270|143240598|SUPERIORITY_OR_OTHER||eta sq|0.157||||0.203|TWO_SIDED||||||Mixed Models Analysis|||||||.203
71862888|NCT01483144|143240607|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.121|TWO_SIDED|95.0|0.4|1.3||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and sulindac plus eflornithine placebo is the denominator.|Intent to treat population with all FAP-related events||1.3|0.4|0.1210
71862889|NCT01483144|143240607|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.1076|TWO_SIDED|95.0|0.4|1.2||The threshold for statistical significance is p=0.05|stratified Cox proportional (Score)||Eflornithine plus sulindac is the numerator and eflornithine plus sulindac placebo is the denominator.|Intent to treat population with all FAP-related events||1.2|0.4|0.1076
71862890|NCT01483144|143240607|SUPERIORITY||Hazard Ratio (HR)|0.2||||0.0201|TWO_SIDED|95.0|0.0|0.8||Threshold for statistical significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and sulindac and eflornithine placebo is the denominator. Reduction in relative risk for FAP-related events with the combination.|Lower GI population||0.8|0.0|0.0201
71862891|NCT01483144|143240607|SUPERIORITY||Hazard Ratio (HR)|0.17||||0.0101|TWO_SIDED|95.0|0.0|0.7||Threshold of significance was p=0.05|stratified Cox proportional (Score)||Eflornithine and sulindac is the numerator and eflornithine and sulindac placebo is the denominator.|Lower GI population||0.7|0|0.0101
71862892|NCT01483144|143240608|SUPERIORITY|||||||0.8127||||||The threshold of significance was p=0.05|Mantel Haenszel|||||||0.8127
71862893|NCT01483144|143240608|SUPERIORITY|||||||0.8133||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.8133
71862894|NCT01483144|143240609|SUPERIORITY|||||||0.999||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.999
71862895|NCT01483144|143240609|SUPERIORITY|||||||0.2152||||||The threshold for significance was p=0.05|Mantel Haenszel|||||||0.2152
71862896|NCT02870972|143240612|SUPERIORITY||Difference in Least Square Means|-0.458|||<|0.001|TWO_SIDED|95.0|-0.703|-0.214|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.214|-0.703|<0.001
71862897|NCT02870972|143240612|SUPERIORITY||Difference in Least Square Means|-0.433||||0.006|TWO_SIDED|95.0|-0.74|-0.127|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.127|-0.740|0.006
71862898|NCT02870972|143240612|SUPERIORITY||Difference in Least Square Means|-0.425||||0.012|TWO_SIDED|95.0|-0.755|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.095|-0.755|0.012
71908580|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.32|2.31|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.32|0.0001
71862899|NCT02870972|143240612|SUPERIORITY||Difference in Least Square Means|-0.703|||<|0.001|TWO_SIDED|95.0|-1.033|0.373|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.373|-1.033|<0.001
71862900|NCT02870972|143240612|SUPERIORITY||Difference in Least Square Means|-0.1||||0.639|TWO_SIDED|95.0|-0.52|0.32|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.32|-0.52|0.639
71862901|NCT02870972|143240613|SUPERIORITY||Difference vs placebo (%)|17.7||||0.155|TWO_SIDED|95.0|-3.4|38.8|||Fisher Exact|||||38.8|-3.4|0.155
71862902|NCT02870972|143240613|SUPERIORITY||Difference vs placebo (%)|16.9||||0.277|TWO_SIDED|95.0|-6.3|40.1|||Fisher Exact|||||40.1|-6.3|0.277
71862903|NCT02870972|143240613|SUPERIORITY||Difference vs placebo (%)|24.0||||0.064|TWO_SIDED|95.0|-1.2|49.2|||Fisher Exact|||||49.2|-1.2|0.064
71862904|NCT02870972|143240613|SUPERIORITY||Difference vs placebo (%)|-4.5||||1|TWO_SIDED|95.0|-13.2|4.2|||Fisher Exact|||||4.2|-13.2|1.000
71862905|NCT02870972|143240613|SUPERIORITY||Difference vs placebo (%)|-16.2||||0.097|TWO_SIDED|95.0|-30.2|-2.2|||Fisher Exact|||||-2.2|-30.2|0.097
71862906|NCT02870972|143240614|SUPERIORITY||Difference in Least Square Means|-0.061||||0.439|TWO_SIDED|95.0|-0.216|0.094|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.094|-0.216|0.439
71862907|NCT02870972|143240614|SUPERIORITY||Difference in Least Square Means|-0.004||||0.968|TWO_SIDED|95.0|-0.198|0.19|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.190|-0.198|0.968
71862908|NCT02870972|143240614|SUPERIORITY||Difference in Least Square Means|-0.045||||0.667|TWO_SIDED|95.0|-0.254|0.164|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.164|-0.254|0.667
71862909|NCT02870972|143240614|SUPERIORITY||Difference in Least Square Means|-0.197||||0.065|TWO_SIDED|95.0|-0.406|0.012|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.012|-0.406|0.065
71862910|NCT02870972|143240614|SUPERIORITY||Difference in Least Square Means|0.035||||0.797|TWO_SIDED|95.0|-0.232|0.301|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.301|-0.232|0.797
71862911|NCT02870972|143240615|SUPERIORITY||Difference in Least Square Means|-0.364|||<|0.001|TWO_SIDED|95.0|-0.547|-0.181|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.181|-0.547|<0.001
71862912|NCT02870972|143240615|SUPERIORITY||Difference in Least Square Means|-0.384||||0.001|TWO_SIDED|95.0|-0.613|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.613|0.001
71862913|NCT02870972|143240615|SUPERIORITY||Difference in Least Square Means|-0.401||||0.002|TWO_SIDED|95.0|-0.647|-0.154|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.154|-0.647|0.002
71862914|NCT02870972|143240615|SUPERIORITY||Difference in Least Square Means|-0.445|||<|0.001|TWO_SIDED|95.0|-0.692|-0.198|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||-0.198|-0.692|<0.001
71862915|NCT02870972|143240615|SUPERIORITY||Difference in Least Square Means|-0.08||||0.614|TWO_SIDED|95.0|-0.394|0.234|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the adjusted qualifying attack rate as the covariate.||0.234|-0.394|0.614
71862916|NCT02870972|143240616|SUPERIORITY||Difference in Least Square Means|-0.326||||0.006|TWO_SIDED|95.0|-0.557|-0.095|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.095|-0.557|0.006
71862917|NCT02870972|143240616|SUPERIORITY||Difference in Least Square Means|-0.293||||0.047|TWO_SIDED|95.0|-0.582|0.004|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.004|-0.582|0.047
71862918|NCT02870972|143240616|SUPERIORITY||Difference in Least Square Means|-0.327||||0.04|TWO_SIDED|95.0|-0.638|-0.016|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.016|-0.638|0.040
71862919|NCT02870972|143240616|SUPERIORITY||Difference in Least Square Means|-0.558|||<|0.001|TWO_SIDED|95.0|-0.87|-0.247|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-0.247|-0.870|<0.001
71862920|NCT02870972|143240616|SUPERIORITY||Difference in Least Square Means|0.057||||0.775|TWO_SIDED|95.0|-0.339|0.454|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.454|-0.339|0.775
71862921|NCT02870972|143240617|SUPERIORITY||Difference in Least Square Means|-4.449||||0.209|TWO_SIDED|95.0|-11.453|2.555|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.555|-11.453|0.209
71862922|NCT02870972|143240617|SUPERIORITY||Difference in Least Square Means|-9.103||||0.019|TWO_SIDED|95.0|-16.639|-1.567|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-1.567|-16.639|0.019
71862923|NCT02870972|143240617|SUPERIORITY||Difference in Least Square Means|-11.263||||0.004|TWO_SIDED|95.0|-18.808|-3.718|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-3.718|-18.808|0.004
71862924|NCT02870972|143240617|SUPERIORITY||Difference in Least Square Means|4.04||||0.405|TWO_SIDED|95.0|-5.586|13.665|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||13.665|-5.586|0.405
71862925|NCT02870972|143240618|SUPERIORITY||Difference in Least Square Means|-8.12||||0.135|TWO_SIDED|95.0|-18.826|2.584|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.584|-18.826|0.135
71681733|NCT00793624|142881779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.952|STANDARD_ERROR_OF_MEAN|1.396||0.4954||95.0|-3.691|1.787|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.787|-3.691|0.4954
71908581|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2757|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2757
71908582|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0575|TWO_SIDED|95.0|0.99|1.65|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.65|0.99|0.0575
71908583|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.52||||0.0015|TWO_SIDED|95.0|1.17|1.96|||Regression, Logistic|||Week 16, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.96|1.17|0.0015
71908584|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
71908585|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0001|TWO_SIDED|95.0|1.31|2.31|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.31|1.31|0.0001
71908586|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0124|TWO_SIDED|95.0|1.07|1.79|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.79|1.07|0.0124
71908587|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0025|TWO_SIDED|95.0|1.15|1.91|||Regression, Logistic|||Week 16, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.15|0.0025
71908588|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0002|TWO_SIDED|95.0|1.33|2.51|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.51|1.33|0.0002
71908589|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.48|2.79|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.79|1.48|<.0001
71908590|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5701|TWO_SIDED|95.0|0.8|1.49|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.49|0.80|0.5701
71908591|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.67||||0.0004|TWO_SIDED|95.0|1.26|2.22|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.22|1.26|0.0004
71908592|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.86|||<|0.0001|TWO_SIDED|95.0|1.4|2.46|||Regression, Logistic|||Week 16, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.46|1.40|<.0001
71908593|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0008|TWO_SIDED|95.0|1.35|3.17|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.17|1.35|0.0008
71908594|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.84||||0.0059|TWO_SIDED|95.0|1.19|2.83|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.83|1.19|0.0059
71908595|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|0.94||||0.7741|TWO_SIDED|95.0|0.6|1.46|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.46|0.60|0.7741
71908596|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.5|3.25|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.25|1.50|<.0001
71908597|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.96||||0.0008|TWO_SIDED|95.0|1.32|2.9|||Regression, Logistic|||Week 16, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.90|1.32|0.0008
71908598|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.25||||0.089|TWO_SIDED|95.0|0.97|1.6|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.97|0.0890
71908599|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0067|TWO_SIDED|95.0|1.1|1.83|||Regression, Logistic|||Week 24, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.83|1.10|0.0067
71908600|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0072|TWO_SIDED|95.0|1.1|1.85|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.85|1.10|0.0072
71908601|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0004|TWO_SIDED|95.0|1.23|2.06|||Regression, Logistic|||Week 24, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.06|1.23|0.0004
71862926|NCT02870972|143240618|SUPERIORITY||Difference in Least Square Means|-8.92||||0.121|TWO_SIDED|95.0|-20.26|2.41|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.410|-20.260|0.121
71862927|NCT02870972|143240618|SUPERIORITY||Difference in Least Square Means|-24.49|||<|0.001|TWO_SIDED|95.0|-35.834|-13.137|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-13.137|-35.834|<0.001
71862928|NCT02870972|143240618|SUPERIORITY||Difference in Least Square Means|-7.84||||0.284|TWO_SIDED|95.0|-22.316|6.64|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||6.640|-22.316|0.284
71862929|NCT02870972|143240619|SUPERIORITY||Difference in Least Square Means|-8.27||||0.067|TWO_SIDED|95.0|-17.132|0.592|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||0.592|-17.132|0.067
71862930|NCT02870972|143240619|SUPERIORITY||Difference in Least Square Means|-7.073||||0.136|TWO_SIDED|95.0|-16.432|2.287|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.287|-16.432|0.136
71862931|NCT02870972|143240619|SUPERIORITY||Difference in Least Square Means|-11.484||||0.015|TWO_SIDED|95.0|-20.642|-2.325|||ANOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||-2.325|-20.642|0.015
71862932|NCT02870972|143240619|SUPERIORITY||Difference in Least Square Means|-9.785||||0.114|TWO_SIDED|95.0|-22.001|2.431|||ANCOVA|||The primary analysis of treatment-effect was performed using an ANCOVA with the terms of treatment and adjusted qualifying attack rate as the covariate.||2.431|-22.001|0.114
71862933|NCT02179177|143240620|OTHER||Mean Difference (Net)|1.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71862934|NCT04052425|143240638|SUPERIORITY||Odds Ratio (OR)|5.28|||<|0.0001|TWO_SIDED|95.0|2.341|11.903||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||11.903|2.341|< 0.0001
71862935|NCT04052425|143240639|SUPERIORITY||Odds Ratio (OR)|5.18|||<|0.0001|TWO_SIDED|95.0|2.831|9.482||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.482|2.831|< 0.0001
71862936|NCT04052425|143240640|SUPERIORITY||Odds Ratio (OR)|8.49||||0.0038|TWO_SIDED|95.0|1.997|36.048||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||36.048|1.997|0.0038
71862937|NCT04052425|143240641|SUPERIORITY||Odds Ratio (OR)|4.93||||0.002|TWO_SIDED|95.0|1.795|13.566||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||13.566|1.795|0.0020
71862938|NCT04052425|143240642|SUPERIORITY||Odds Ratio (OR)|9.53||||0.0002|TWO_SIDED|95.0|2.9|31.29||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||31.290|2.900|0.0002
71862939|NCT04052425|143240643|SUPERIORITY||least squares mean difference|-19.3|STANDARD_ERROR_OF_MEAN|3.93|<|0.0001|TWO_SIDED|95.0|-27.05|-11.64||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-11.64|-27.05|< 0.0001
71862940|NCT04052425|143240646|SUPERIORITY||Odds Ratio (OR)|5.56|||<|0.0001|TWO_SIDED|95.0|3.226|9.578||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.578|3.226|< 0.0001
71862941|NCT04052425|143240648|SUPERIORITY||least squares mean difference|-30.61|STANDARD_ERROR_OF_MEAN|4.28|<|0.0001|TWO_SIDED|95.0|-39.03|-22.19|||mixed-effect model; repeated measurement|||||-22.19|-39.03|<0.0001
71862942|NCT04052425|143240651|SUPERIORITY||least squares mean difference|-16.98|STANDARD_ERROR_OF_MEAN|3.2|<|0.0001|TWO_SIDED|95.0|-23.28|-10.68|||mixed-effect model; repeated measurement|||||-10.68|-23.28|<0.0001
71862943|NCT04052425|143240653|SUPERIORITY||least squares mean difference|-9.07|STANDARD_ERROR_OF_MEAN|2.49||0.0003|TWO_SIDED|95.0|-13.96|-4.18|||mixed-effect model; repeated measurement|||||-4.18|-13.96|0.0003
71862944|NCT04052425|143240655|SUPERIORITY||Odds Ratio (OR)|3.04|||<|0.0001|TWO_SIDED|95.0|1.746|5.307||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||5.307|1.746|< 0.0001
71862945|NCT04052425|143240655|SUPERIORITY||Odds Ratio (OR)|2.3||||0.2921|TWO_SIDED|95.0|0.489|10.823||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||10.823|0.489|0.2921
71862946|NCT04052425|143240655|SUPERIORITY||Odds Ratio (OR)|0.49||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
71862947|NCT04052425|143240658|SUPERIORITY||least squares mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.497|TWO_SIDED|95.0|-1.26|0.62|||mixed-effect model; repeated measurement|||||0.62|-1.26|0.4970
71862948|NCT02330094|143240669|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.7
71862949|NCT02330094|143240670|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
71862950|NCT02330094|143240671|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
71862951|NCT01189110|143240711|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81|STANDARD_ERROR_OF_MEAN|0.42||0.74|TWO_SIDED|95.0|0.23|2.83|||Chi-squared|||A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.||2.83|0.23|0.74
71681734|NCT00793624|142881780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.785|STANDARD_ERROR_OF_MEAN|1.387||0.045||95.0|-5.507|-0.063|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.063|-5.507|0.0450
71908602|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0013|TWO_SIDED|95.0|1.2|2.15|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.15|1.20|0.0013
71908603|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.79|||<|0.0001|TWO_SIDED|95.0|1.34|2.39|||Regression, Logistic|||Week 24, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.39|1.34|<.0001
71908604|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.23|||<|0.0001|TWO_SIDED|95.0|1.51|3.3|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.30|1.51|<.0001
71908605|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|2.53|||<|0.0001|TWO_SIDED|95.0|1.72|3.71|||Regression, Logistic|||Week 24, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||3.71|1.72|<.0001
71908606|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.26||||0.0732|TWO_SIDED|95.0|0.98|1.62|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.62|0.98|0.0732
71908607|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.3||||0.0399|TWO_SIDED|95.0|1.01|1.68|||Regression, Logistic|||Week 32, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.68|1.01|0.0399
71908608|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.29||||0.0536|TWO_SIDED|95.0|1.0|1.67|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.67|1.00|0.0536
71908609|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0043|TWO_SIDED|95.0|1.12|1.88|||Regression, Logistic|||Week 32, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.12|0.0043
71908610|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0143|TWO_SIDED|95.0|1.07|1.91|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.91|1.07|0.0143
71908611|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.63||||0.0007|TWO_SIDED|95.0|1.23|2.16|||Regression, Logistic|||Week 32, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.16|1.23|0.0007
71908612|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.67||||0.005|TWO_SIDED|95.0|1.17|2.38|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.38|1.17|0.0050
71908613|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0043|TWO_SIDED|95.0|1.18|2.4|||Regression, Logistic|||Week 32, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.18|0.0043
71908614|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.15||||0.2777|TWO_SIDED|95.0|0.89|1.48|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.48|0.89|0.2777
71908615|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0326|TWO_SIDED|95.0|1.02|1.7|||Regression, Logistic|||Week 40, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.70|1.02|0.0326
71908616|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.19||||0.1823|TWO_SIDED|95.0|0.92|1.55|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.92|0.1823
71908617|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.32||||0.035|TWO_SIDED|95.0|1.02|1.71|||Regression, Logistic|||Week 40, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.71|1.02|0.0350
71908618|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0164|TWO_SIDED|95.0|1.07|1.88|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.88|1.07|0.0164
71908619|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0257|TWO_SIDED|95.0|1.04|1.84|||Regression, Logistic|||Week 40, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.84|1.04|0.0257
71908620|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.64||||0.007|TWO_SIDED|95.0|1.14|2.35|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.35|1.14|0.0070
71908621|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0085|TWO_SIDED|95.0|1.13|2.32|||Regression, Logistic|||Week 40, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.32|1.13|0.0085
71908622|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.09||||0.4925|TWO_SIDED|95.0|0.85|1.41|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.41|0.85|0.4925
71908623|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1534|TWO_SIDED|95.0|0.93|1.55|||Regression, Logistic|||Week 48, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.55|0.93|0.1534
71908624|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1202|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1202
71681735|NCT00793624|142881780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.144|STANDARD_ERROR_OF_MEAN|1.386||0.0002||95.0|-7.864|-2.425|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-2.425|-7.864|0.0002
71681736|NCT00793624|142881780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.754|STANDARD_ERROR_OF_MEAN|1.386||0.2061||95.0|-4.474|0.966|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.966|-4.474|0.2061
71681737|NCT00793624|142881781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.871|STANDARD_ERROR_OF_MEAN|1.419||0.1878||95.0|-4.655|0.914|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.914|-4.655|0.1878
71862952|NCT01516749|143240714|SUPERIORITY_OR_OTHER|||||||0.024||||||significance was accepted at p\<0.05|t-test, 2 sided|||Significance of decrease in modified Sartorius score from Baseline to 8 weeks||||0.024
71862953|NCT01516749|143240715|SUPERIORITY_OR_OTHER|||||||0.006||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy||||0.006
71862954|NCT01516749|143240715|SUPERIORITY_OR_OTHER|||||||0.019||||||Significance was accepted at p\<0.05|t-test, 2 sided|||Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy||||0.019
71862955|NCT01732549|143240727|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0315||||||Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.|Log Rank|||Stratified\[a\]||||=0.0315
71862956|NCT01732549|143240727|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.0344|||||||Log Rank|||Unstratified\[b\]||||=0.0344
71862957|NCT01732549|143240728|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.443|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.4430
71862958|NCT01732549|143240729|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5219|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||0.5219
71862959|NCT01732549|143240730|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.5442|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.5442
71862960|NCT01732549|143240731|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.112|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.1120
71862961|NCT01732549|143240732|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.2491|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) \& region (Eastern Europe, Western Europe). One-sided p-value||Stratified\[a\]||||=0.2491
71862962|NCT00584077|143240735|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|95.0|||||ANOVA|||Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)||||<0.01
71862963|NCT00584077|143240736|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value was adjusted for multiple comparisons using Bonferroni test|ANOVA|||For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.||||<0.01
71862964|NCT00447590|143240811|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||2-sided Exact Binomial Test|||p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.||||<0.0001
71862965|NCT04079634|143240880|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71862966|NCT03321253|143240916|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71862967|NCT02358668|143240956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.57|TWO_SIDED|95.0|-6.28|11.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.20|-6.28|0.57
71862968|NCT02358668|143240956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.57||||0.72|TWO_SIDED|95.0|-10.3|7.11||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||7.11|-10.3|0.72
71862969|NCT02358668|143240957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.66|TWO_SIDED|95.0|-0.91|1.42||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.42|-0.91|0.66
71862970|NCT02358668|143240957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9|TWO_SIDED|95.0|-1.03|1.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.18|-1.03|0.90
71908625|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1222|TWO_SIDED|95.0|0.95|1.6|||Regression, Logistic|||Week 48, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.60|0.95|0.1222
71908626|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0179|TWO_SIDED|95.0|1.06|1.9|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.90|1.06|0.0179
71908627|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.49||||0.0065|TWO_SIDED|95.0|1.12|1.99|||Regression, Logistic|||Week 48, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.99|1.12|0.0065
71908628|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0223|TWO_SIDED|95.0|1.06|2.2|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.20|1.06|0.0223
71908629|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0045|TWO_SIDED|95.0|1.17|2.4|||Regression, Logistic|||Week 48, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.40|1.17|0.0045
71908630|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9385|TWO_SIDED|95.0|0.77|1.28|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.28|0.77|0.9385
71862971|NCT02358668|143240958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.86|TWO_SIDED|95.0|-0.5|0.59||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.59|-0.50|0.86
71862972|NCT02358668|143240958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.59|TWO_SIDED|95.0|-0.66|0.38||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.38|-0.66|0.59
71908631|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.23||||0.1093|TWO_SIDED|95.0|0.95|1.59|||Regression, Logistic|||Week 56, \>=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.59|0.95|0.1093
71908632|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.21||||0.1631|TWO_SIDED|95.0|0.93|1.57|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.57|0.93|0.1631
71908633|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.34||||0.0285|TWO_SIDED|95.0|1.03|1.74|||Regression, Logistic|||Week 56, \>=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.74|1.03|0.0285
71908634|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.36||||0.0389|TWO_SIDED|95.0|1.02|1.81|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.81|1.02|0.0389
71908635|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.39||||0.024|TWO_SIDED|95.0|1.04|1.86|||Regression, Logistic|||Week 56, \>=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||1.86|1.04|0.0240
71908636|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.64||||0.0063|TWO_SIDED|95.0|1.15|2.34|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.34|1.15|0.0063
71908637|NCT02528253|143339057|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0021|TWO_SIDED|95.0|1.22|2.47|||Regression, Logistic|||Week 56, \>=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.||2.47|1.22|0.0021
71908638|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.13||0.0003|TWO_SIDED|95.0|-0.75|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.75|0.0003
71908639|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.85|-0.33|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.33|-0.85|<.0001
71922089|NCT03091920|143364995|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|4.19|||TWO_SIDED|95.0|-7.84|9.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||9.58|-7.84|
71862973|NCT02358668|143240959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.62|TWO_SIDED|95.0|-0.44|0.73||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.73|-0.44|0.62
71862974|NCT02358668|143240959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.97|TWO_SIDED|95.0|-0.52|0.55||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.55|-0.52|0.97
71908640|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0615|TWO_SIDED|95.0|-0.47|0.01|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.47|0.0615
71908641|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.12||0.0356|TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.50|0.0356
71908642|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.0032|TWO_SIDED|95.0|-0.6|-0.12|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.60|0.0032
71908643|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.16||0.0003|TWO_SIDED|95.0|-0.88|-0.27|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.27|-0.88|0.0003
71908644|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.08|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.08|<.0001
71908645|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.15||0.0844|TWO_SIDED|95.0|-0.54|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.54|0.0844
71908646|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.6|-0.04|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.60|0.0258
71908647|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.15||0.0004|TWO_SIDED|95.0|-0.8|-0.23|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.23|-0.80|0.0004
71908648|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0079|TWO_SIDED|95.0|-0.78|-0.12|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.78|0.0079
71908649|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.08|-0.41|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-1.08|<.0001
71908650|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.16||0.0977|TWO_SIDED|95.0|-0.57|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.57|0.0977
71908651|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.215|TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.50|0.2150
71908652|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.15||0.0016|TWO_SIDED|95.0|-0.79|-0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.79|0.0016
71908653|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0058|TWO_SIDED|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.88|0.0058
71681738|NCT00793624|142881781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.565|STANDARD_ERROR_OF_MEAN|1.427||0.0126||95.0|-6.364|-0.767|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.767|-6.364|0.0126
71862975|NCT02358668|143240960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.4|TWO_SIDED|95.0|-0.2|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-0.20|0.40
71862976|NCT02358668|143240960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.49|TWO_SIDED|95.0|-0.21|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.21|0.49
71862977|NCT02358668|143240961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84||||0.41|TWO_SIDED|95.0|-2.88|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-2.88|0.41
71862978|NCT02358668|143240961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.34||||0.15|TWO_SIDED|95.0|-3.18|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.51|-3.18|0.15
71862979|NCT02358668|143240962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.64|TWO_SIDED|95.0|-0.29|0.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.18|-0.29|0.64
71862980|NCT02358668|143240962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.41|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.12|-0.30|0.41
71862981|NCT02358668|143240963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.19||||0.46|TWO_SIDED|95.0|-4.43|2.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.05|-4.43|0.46
71862982|NCT02358668|143240963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.75||||0.24|TWO_SIDED|95.0|-4.72|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.21|-4.72|0.24
71862983|NCT02358668|143240964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.83|TWO_SIDED|95.0|-0.13|0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.10|-0.13|0.83
71862984|NCT02358668|143240964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.48|TWO_SIDED|95.0|-0.16|0.08||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.08|-0.16|0.48
71862985|NCT02358668|143240965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.14||||0.83|TWO_SIDED|95.0|-9.17|11.45||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||11.45|-9.17|0.83
71862986|NCT02358668|143240965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.92||||0.86|TWO_SIDED|95.0|-11.1|9.27||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||9.27|-11.1|0.86
71862987|NCT02358668|143240966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6||||0.75|TWO_SIDED|95.0|-99.6|72.3||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||72.3|-99.6|0.75
71862988|NCT02358668|143240966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.0||||0.34|TWO_SIDED|95.0|-43.9|123.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||123.9|-43.9|0.34
71862989|NCT02358668|143240967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-980.0||||0.23|TWO_SIDED|95.0|-2604.0|643.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||643.8|-2604|0.23
71862990|NCT02358668|143240967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|323.9||||0.68|TWO_SIDED|95.0|-1269.0|1916.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1916.6|-1269|0.68
71862991|NCT02358668|143240968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.0||||0.79|TWO_SIDED|95.0|-99.6|129.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||129.6|-99.6|0.79
71862992|NCT02358668|143240968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|60.1||||0.29|TWO_SIDED|95.0|-52.5|172.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||172.6|-52.5|0.29
71862993|NCT02358668|143240969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-120.2||||0.37|TWO_SIDED|95.0|-385.3|144.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||144.9|-385.3|0.37
71862994|NCT02358668|143240969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|49.0||||0.69|TWO_SIDED|95.0|-198.1|296.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||296.2|-198.1|0.69
71862995|NCT02358668|143240971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.57|TWO_SIDED|95.0|-9.8|5.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||5.5|-9.8|0.57
71862996|NCT02358668|143240971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.79|TWO_SIDED|95.0|-6.6|8.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||8.6|-6.6|0.79
71862997|NCT02358668|143240972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.54|TWO_SIDED|95.0|-3.4|1.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.8|-3.4|0.54
71862998|NCT02358668|143240972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.68|TWO_SIDED|95.0|-2.0|3.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.1|-2.0|0.68
71681739|NCT00793624|142881781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|1.426||0.9913||95.0|-2.782|2.814|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||2.814|-2.782|0.9913
71681740|NCT00793624|142881782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.846|STANDARD_ERROR_OF_MEAN|0.972||0.0034||95.0|-4.751|-0.94|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||-0.940|-4.751|0.0034
71862999|NCT02358668|143240973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.03|TWO_SIDED|95.0|-3.2|-0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||-0.1|-3.2|0.03
71908654|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.19||0.0038|TWO_SIDED|95.0|-0.91|-0.18|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.91|0.0038
71908655|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.17||0.1707|TWO_SIDED|95.0|-0.58|0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.58|0.1707
71908656|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.17||0.1083|TWO_SIDED|95.0|-0.62|0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.62|0.1083
71908657|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0734|TWO_SIDED|95.0|-0.64|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.64|0.0734
71908658|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.21||0.4603|TWO_SIDED|95.0|-0.56|0.25|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.56|0.4603
71908659|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0799|TWO_SIDED|95.0|-0.74|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.74|0.0799
71863000|NCT02358668|143240973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.86|TWO_SIDED|95.0|-1.7|1.4||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.4|-1.7|0.86
71863001|NCT02358668|143240974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.9|TWO_SIDED|95.0|-0.39|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.44|-0.39|0.90
71863002|NCT02358668|143240974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.3|TWO_SIDED|95.0|-0.63|0.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.20|-0.63|0.30
71863003|NCT02358668|143240975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.52|TWO_SIDED|95.0|-1.32|2.57||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||2.57|-1.32|0.52
71863004|NCT02358668|143240975|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.13||||0.24|TWO_SIDED|95.0|-0.75|3.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||3.05|-0.75|0.24
71863005|NCT02358668|143240976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.002||||0.93|TWO_SIDED|95.0|-0.035|0.038||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.038|-0.035|0.93
71863006|NCT02358668|143240976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.015||||0.4|TWO_SIDED|95.0|-0.021|0.051||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.051|-0.021|0.40
71863007|NCT02358668|143240977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.36|TWO_SIDED|95.0|-1.2|0.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||0.5|-1.2|0.36
71863008|NCT02358668|143240977|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.36|TWO_SIDED|95.0|-0.4|1.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA|||||1.2|-0.4|0.36
71863009|NCT02358668|143240978|SUPERIORITY_OR_OTHER|||||||0.09||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.09
71863010|NCT02358668|143240978|SUPERIORITY_OR_OTHER|||||||0.82||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.82
71863011|NCT02358668|143240979|SUPERIORITY_OR_OTHER|||||||0.68||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.68
71863012|NCT02358668|143240979|SUPERIORITY_OR_OTHER|||||||0.26||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.26
71863013|NCT02358668|143240980|SUPERIORITY_OR_OTHER|||||||0.67||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.67
71863014|NCT02358668|143240980|SUPERIORITY_OR_OTHER|||||||0.3||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.30
71863015|NCT02358668|143240981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.01|TWO_SIDED|95.0|-0.48|-0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.11|-0.48|<0.01
71863016|NCT02358668|143240981|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.13|TWO_SIDED|95.0|-0.32|0.04||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.04|-0.32|0.13
71863017|NCT02358668|143240982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.01|TWO_SIDED|95.0|-1.01|-0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.18|-1.01|0.01
71863018|NCT02358668|143240982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.42|TWO_SIDED|95.0|-0.57|0.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.24|-0.57|0.42
71863019|NCT02358668|143240983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.74||||0.02|TWO_SIDED|95.0|-1.35|-0.14||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.14|-1.35|0.02
71863020|NCT02358668|143240983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.57|TWO_SIDED|95.0|-0.75|0.42||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.42|-0.75|0.57
71863021|NCT02358668|143240984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32|||<|0.01|TWO_SIDED|95.0|-0.52|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.52|<0.01
71863022|NCT02358668|143240984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.14|TWO_SIDED|95.0|-0.34|0.05||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.05|-0.34|0.14
71863023|NCT02358668|143240985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|||<|0.01|TWO_SIDED|95.0|-0.52|-0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.10|-0.52|<0.01
71863024|NCT02358668|143240985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.38|TWO_SIDED|95.0|-0.3|0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.12|-0.30|0.38
71863025|NCT02358668|143240986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.01|TWO_SIDED|95.0|-0.48|-0.07||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.07|-0.48|0.01
71681741|NCT00793624|142881782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.434|STANDARD_ERROR_OF_MEAN|0.973||0.0004||95.0|-5.343|-1.525|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||-1.525|-5.343|0.0004
71681742|NCT00793624|142881782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.248|STANDARD_ERROR_OF_MEAN|0.976||0.2009||95.0|-3.161|0.665|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 10 mcg qd minus Placebo||0.665|-3.161|0.2009
71863026|NCT02358668|143240986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.41|TWO_SIDED|95.0|-0.28|0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.11|-0.28|0.41
71863027|NCT02358668|143240987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.40|0.08
71863028|NCT02358668|143240987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.1|TWO_SIDED|95.0|-0.38|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.03|-0.38|0.10
71863029|NCT02358668|143240988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.01|TWO_SIDED|95.0|-0.67|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.12|-0.67|0.01
71863030|NCT02358668|143240988|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.54|TWO_SIDED|95.0|-0.35|0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.18|-0.35|0.54
71863031|NCT02358668|143240989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.03|TWO_SIDED|95.0|-0.81|-0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.03|-0.81|0.03
71908660|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.21||0.2339|TWO_SIDED|95.0|-0.66|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.66|0.2339
71681743|NCT00793624|142881783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.146|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.226|0.146|<0.0001
71863032|NCT02358668|143240989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.63|TWO_SIDED|95.0|-0.48|0.29||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.29|-0.48|0.63
71863033|NCT02358668|143240990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.18|TWO_SIDED|95.0|-0.13|0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.02|-0.13|0.18
71863034|NCT02358668|143240990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.73|TWO_SIDED|95.0|-0.06|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-0.06|0.73
71863035|NCT02358668|143240991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
71863036|NCT02358668|143240991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
71863037|NCT02358668|143240992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.06|TWO_SIDED|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.00|-0.15|0.06
71863038|NCT02358668|143240992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.46|TWO_SIDED|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.10|-0.05|0.46
71863039|NCT02358668|143240993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.16||||0.03|TWO_SIDED|95.0|-0.31|-0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||-0.02|-0.31|0.03
71863040|NCT02358668|143240993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.87|TWO_SIDED|95.0|-0.13|0.15||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.15|-0.13|0.87
71863041|NCT02358668|143240994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.34|TWO_SIDED|95.0|-1.46|0.5||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.50|-1.46|0.34
71863042|NCT02358668|143240994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.64|TWO_SIDED|95.0|-0.73|1.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.18|-0.73|0.64
71863043|NCT02358668|143240995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.62||||0.17|TWO_SIDED|95.0|-1.5|0.26||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.26|-1.50|0.17
71863044|NCT02358668|143240995|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.37|TWO_SIDED|95.0|-0.46|1.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.24|-0.46|0.37
71863045|NCT02358668|143240996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.18|TWO_SIDED|95.0|-1.62|0.31||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.31|-1.62|0.18
71863046|NCT02358668|143240996|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.42||||0.37|TWO_SIDED|95.0|-0.51|1.36||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||1.36|-0.51|0.37
71863047|NCT02358668|143240997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.14||||0.06|TWO_SIDED|95.0|-4.36|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||0.09|-4.36|0.06
71863048|NCT02358668|143240997|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.43||||0.69|TWO_SIDED|95.0|-1.71|2.58||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis|||||2.58|-1.71|0.69
71908661|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.21||0.1199|TWO_SIDED|95.0|-0.73|0.08|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.08|-0.73|0.1199
71908662|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.21||0.384|TWO_SIDED|95.0|-0.6|0.23|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.60|0.3840
71908663|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.21||0.2|TWO_SIDED|95.0|-0.68|0.14|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.68|0.2000
71908664|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2997|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2997
71908665|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.1778|TWO_SIDED|95.0|-0.71|0.13|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.71|0.1778
71908666|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3438|TWO_SIDED|95.0|-0.65|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.65|0.3438
71908667|NCT02528253|143339059|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.22||0.1876|TWO_SIDED|95.0|-0.71|0.14|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.14|-0.71|0.1876
71908668|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.13||0.0002|TWO_SIDED|95.0|-0.72|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.72|0.0002
71908669|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.79|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.79|<.0001
71908670|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0193|TWO_SIDED|95.0|-0.5|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.50|0.0193
71908671|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0845|TWO_SIDED|95.0|-0.42|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.42|0.0845
71908672|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.12||0.0212|TWO_SIDED|95.0|-0.49|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.49|0.0212
71908673|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.81|-0.24|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.81|0.0003
71908674|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.99|-0.41|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.41|-0.99|<.0001
71908675|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.14||0.079|TWO_SIDED|95.0|-0.5|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.50|0.0790
71908676|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.14||0.0336|TWO_SIDED|95.0|-0.55|-0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.55|0.0336
71681744|NCT00793624|142881783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.126|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.206|0.126|<0.0001
71908677|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.14||0.0008|TWO_SIDED|95.0|-0.73|-0.19|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.73|0.0008
71908678|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.16||0.0034|TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.77|0.0034
71908679|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.01|-0.39|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.01|<.0001
71908680|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.15||0.0361|TWO_SIDED|95.0|-0.59|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.59|0.0361
71908681|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.15||0.2786|TWO_SIDED|95.0|-0.44|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.44|0.2786
71908682|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0058|TWO_SIDED|95.0|-0.68|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.68|0.0058
71908683|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.18||0.0365|TWO_SIDED|95.0|-0.71|-0.02|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.71|0.0365
71908684|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0092|TWO_SIDED|95.0|-0.8|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.80|0.0092
71908685|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.2923|TWO_SIDED|95.0|-0.49|0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.49|0.2923
71908686|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.2231|TWO_SIDED|95.0|-0.51|0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.51|0.2231
71908687|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0724|TWO_SIDED|95.0|-0.6|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.60|0.0724
71908688|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.19||0.4776|TWO_SIDED|95.0|-0.5|0.23|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.50|0.4776
71908689|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.19||0.1482|TWO_SIDED|95.0|-0.64|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.64|0.1482
71908690|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.19||0.3249|TWO_SIDED|95.0|-0.56|0.18|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.56|0.3249
71922090|NCT03091920|143364995|OTHER|No statistical testing was performed.|Least squares mean difference|-2.98|STANDARD_ERROR_OF_MEAN|3.96|||TWO_SIDED|95.0|-11.23|5.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.26|-11.23|
71681745|NCT00793624|142881783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.166|0.246|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.246|0.166|<0.0001
71908691|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.19||0.1997|TWO_SIDED|95.0|-0.62|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.62|0.1997
71908692|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4823|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.25|-0.53|0.4823
71908693|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.2||0.2754|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2754
71908694|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5861|TWO_SIDED|95.0|-0.5|0.29|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.50|0.5861
71908695|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.2||0.4346|TWO_SIDED|95.0|-0.54|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.54|0.4346
71908696|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8752|TWO_SIDED|95.0|-0.42|0.36|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.36|-0.42|0.8752
71908697|NCT02528253|143339061|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.2||0.2663|TWO_SIDED|95.0|-0.6|0.17|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.60|0.2663
71908698|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0013|TWO_SIDED|95.0|-0.77|-0.19|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.19|-0.77|0.0013
71908699|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.15||0.0001|TWO_SIDED|95.0|-0.87|-0.28|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.87|0.0001
71908700|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.14||0.2272|TWO_SIDED|95.0|-0.43|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.43|0.2272
71908701|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0209|TWO_SIDED|95.0|-0.58|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.58|0.0209
71908702|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.14||0.0029|TWO_SIDED|95.0|-0.67|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.67|0.0029
71908703|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.92|-0.28|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-0.92|0.0002
71908704|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.1|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.46|-1.10|<.0001
71908705|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1198|TWO_SIDED|95.0|-0.53|0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.53|0.1198
71908706|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.15||0.016|TWO_SIDED|95.0|-0.66|-0.07|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.07|-0.66|0.0160
71863049|NCT02358668|143240998|SUPERIORITY_OR_OTHER|||||||0.29||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.29
71908707|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.15||0.0003|TWO_SIDED|95.0|-0.85|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.85|0.0003
71908708|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.17||0.0091|TWO_SIDED|95.0|-0.77|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.77|0.0091
71908709|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.90|0.0007
71908710|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2264|TWO_SIDED|95.0|-0.48|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.48|0.2264
71908711|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0961|TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.56|0.0961
71908712|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.15||0.0121|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0121
71908713|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.18||0.027|TWO_SIDED|95.0|-0.77|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.77|0.0270
71908714|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.18||0.0019|TWO_SIDED|95.0|-0.94|-0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.94|0.0019
71681746|NCT00793624|142881784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.136|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.217|0.136|<0.0001
71863050|NCT02358668|143240998|SUPERIORITY_OR_OTHER|||||||0.22||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.22
71863051|NCT02358668|143240999|SUPERIORITY_OR_OTHER|||||||0.41||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.41
71908715|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3906|TWO_SIDED|95.0|-0.48|0.19|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.48|0.3906
71863052|NCT02358668|143240999|SUPERIORITY_OR_OTHER|||||||0.48||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.48
71863053|NCT02358668|143241000|SUPERIORITY_OR_OTHER|||||||0.61||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.61
71863054|NCT02358668|143241000|SUPERIORITY_OR_OTHER|||||||0.89||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided|||||||0.89
71863055|NCT04057573|143241001|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0004|TWO_SIDED|95.0|1.737|6.835||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.835|1.737|0.0004
71863056|NCT04057573|143241002|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.0001|TWO_SIDED|95.0|2.296|6.949||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.949|2.296|< 0.0001
71681747|NCT00793624|142881784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.119|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.119|<0.0001
71863057|NCT04057573|143241003|SUPERIORITY||Odds Ratio (OR)|15.29||||0.0065|TWO_SIDED|95.0|2.15|108.739||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||108.739|2.150|0.0065
71863058|NCT04057573|143241004|SUPERIORITY||Odds Ratio (OR)|4.29||||0.0006|TWO_SIDED|95.0|1.865|9.853||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||9.853|1.865|0.0006
71863059|NCT04057573|143241005|SUPERIORITY||Odds Ratio (OR)|4.86||||0.0013|TWO_SIDED|95.0|1.851|12.755||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||12.755|1.851|0.0013
71863060|NCT04057573|143241006|SUPERIORITY||Least squares mean difference|-19.5|STANDARD_ERROR_OF_MEAN|4.59|<|0.0001|TWO_SIDED|95.0|-28.46|-10.45||Response Variable = Treatment + Stratification Factors (Skin Type Fitzpatrick scale Type I, II versus Type III, IV, V, and VI, Region North America/Europe) + Baseline|ANCOVA|||||-10.45|-28.46|< 0.0001
71863061|NCT04057573|143241009|SUPERIORITY||Odds Ratio (OR)|3.76|||<|0.0001|TWO_SIDED|95.0|2.267|6.246||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||||6.246|2.267|< 0.0001
71863062|NCT04057573|143241011|SUPERIORITY||Least squares mean difference|-28.59|STANDARD_ERROR_OF_MEAN|4.94|<|0.0001|TWO_SIDED|95.0|-38.33|-18.86|||mixed-effect model; repeated measurement|||||-18.86|-38.33|<0.0001
71863063|NCT04057573|143241014|SUPERIORITY||least squares mean difference|-19.85|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001|TWO_SIDED|95.0|-26.55|-13.16|||mixed-effect model; repeated measurement|||||-13.16|-26.55|<0.0001
71863064|NCT04057573|143241016|SUPERIORITY||least squares mean difference|-11.95|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-17.23|-6.67|||mixed-effect model; repeated measurement|||||-6.67|-17.23|<0.0001
71681748|NCT00793624|142881784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.152|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.152|<0.0001
71863065|NCT04057573|143241018|SUPERIORITY||Odds Ratio (OR)|3.75|||<|0.0001|TWO_SIDED|95.0|2.121|6.63||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI25||6.630|2.121|< 0.0001
71863066|NCT04057573|143241018|SUPERIORITY||Odds Ratio (OR)|4.59||||0.0436|TWO_SIDED|95.0|1.045|20.192||The model included the treatment group (1.5% BID and vehicle) and stratification factors (skin type and region).|exact logistic regression|||T-VASI75||20.192|1.045|0.0436
71863067|NCT04057573|143241018|SUPERIORITY||Odds Ratio (OR)|1.35||||||||||The p value was not evaluable because the response rate in the vehicle group was too low.||||T-VASI90||||
71863068|NCT04057573|143241021|SUPERIORITY||least squares mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.51||0.235|TWO_SIDED|95.0|-1.6|0.39|||mixed-effect model; repeated measurement|||||0.39|-1.60|0.2350
71863069|NCT01381575|143241034|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.08|0.78||||||Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.78|-1.08|
71863070|NCT01381575|143241034|NON_INFERIORITY|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||TWO_SIDED|95.0|-1.0|0.77||||||Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.77|-1.00|
71863071|NCT01381575|143241035|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|1.09|||||TWO_SIDED|95.0|0.97|1.22||||||Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||1.22|0.97|
71882509|NCT01505634|143284125|OTHER|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|TWO_SIDED|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #1||5.5|-2.7|0.315
71882510|NCT01505634|143284126|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff Participants with ECI #2||3.8|-3.7|> 0.999
71908716|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.17||0.1209|TWO_SIDED|95.0|-0.59|0.07|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.59|0.1209
71908717|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.17||0.0107|TWO_SIDED|95.0|-0.76|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.76|0.0107
71908718|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.19||0.2396|TWO_SIDED|95.0|-0.61|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.61|0.2396
71908719|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.19||0.1088|TWO_SIDED|95.0|-0.69|0.07|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.69|0.1088
71908720|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1673|TWO_SIDED|95.0|-0.65|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.65|0.1673
71908721|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1751|TWO_SIDED|95.0|-0.66|0.12|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.66|0.1751
71908722|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3164|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3164
71908723|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2253|TWO_SIDED|95.0|-0.62|0.15|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.62|0.2253
71908724|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3408|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3408
71908725|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.3391|TWO_SIDED|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.58|0.3391
71908726|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.2||0.5818|TWO_SIDED|95.0|-0.5|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.50|0.5818
71908727|NCT02528253|143339063|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2562|TWO_SIDED|95.0|-0.62|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.62|0.2562
71908728|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.0137|TWO_SIDED|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.69|0.0137
71908729|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0044|TWO_SIDED|95.0|-0.76|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.14|-0.76|0.0044
71908730|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.14||0.6194|TWO_SIDED|95.0|-0.35|0.21|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.35|0.6194
71922091|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|3.84|||TWO_SIDED|95.0|-13.51|2.41|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-13.51|
71863072|NCT01381575|143241035|NON_INFERIORITY|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.76|0.95||||||Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.||0.95|0.76|
71908731|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.0271|TWO_SIDED|95.0|-0.59|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.59|0.0271
71908732|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0085|TWO_SIDED|95.0|-0.66|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.66|0.0085
71908733|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.18||0.0027|TWO_SIDED|95.0|-0.87|-0.18|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.87|0.0027
71908734|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.78|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.13|-0.44|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.44|-1.13|<.0001
71908735|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1859|TWO_SIDED|95.0|-0.54|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.54|0.1859
71908736|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.16||0.0573|TWO_SIDED|95.0|-0.63|0.01|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.01|-0.63|0.0573
71908737|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0005|TWO_SIDED|95.0|-0.88|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-0.88|0.0005
71908738|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.18||0.0841|TWO_SIDED|95.0|-0.66|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.66|0.0841
71908739|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.18||0.0074|TWO_SIDED|95.0|-0.85|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.85|0.0074
71908740|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.16||0.316|TWO_SIDED|95.0|-0.49|0.16|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.16|-0.49|0.3160
71908741|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.17||0.3763|TWO_SIDED|95.0|-0.47|0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.47|0.3763
71908742|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0505|TWO_SIDED|95.0|-0.65|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.00|-0.65|0.0505
71908743|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0118|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.88|0.0118
71922092|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-2.47|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|95.0|-10.41|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||5.47|-10.41|
71863073|NCT01443403|143241072|SUPERIORITY_OR_OTHER||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.605||0.0003|TWO_SIDED|95.0|1.02|3.41|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.||||3.41|1.02|0.0003
71908744|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.0012|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.25|-1.03|0.0012
71908745|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2966|TWO_SIDED|95.0|-0.54|0.17|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.54|0.2966
71908746|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0956|TWO_SIDED|95.0|-0.66|0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.66|0.0956
71863074|NCT01443403|143241072|SUPERIORITY_OR_OTHER||LS Mean Difference|1.95|STANDARD_ERROR_OF_MEAN|0.604||0.0014|TWO_SIDED|95.0|0.76|3.14|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.14|0.76|0.0014
71863075|NCT01443403|143241072|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|0.599||0.3504|TWO_SIDED|95.0|-0.62|1.74|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.74|-0.62|0.3504
71863076|NCT01443403|143241074|SUPERIORITY_OR_OTHER||LS Mean Difference|1.93|STANDARD_ERROR_OF_MEAN|0.568||0.0008|TWO_SIDED|95.0|0.81|3.05|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.05|0.81|0.0008
71863077|NCT01443403|143241074|SUPERIORITY_OR_OTHER||LS Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|0.569||0.0009|TWO_SIDED|95.0|0.79|3.04|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.04|0.79|0.0009
71863078|NCT01443403|143241074|SUPERIORITY_OR_OTHER||LS Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.558||0.2572|TWO_SIDED|95.0|-0.47|1.73|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.73|-0.47|0.2572
71908747|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0117|TWO_SIDED|95.0|-0.81|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||-0.10|-0.81|0.0117
71908748|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.2||0.3732|TWO_SIDED|95.0|-0.57|0.21|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.57|0.3732
71863079|NCT01443403|143241076|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.484||0.0065|TWO_SIDED|95.0|0.38|2.28|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.28|0.38|0.0065
71863080|NCT01443403|143241076|SUPERIORITY_OR_OTHER||LS Mean Difference|1.64|STANDARD_ERROR_OF_MEAN|0.482||0.0008|TWO_SIDED|95.0|0.69|2.58|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.58|0.69|0.0008
71863081|NCT01443403|143241076|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.476||0.2921|TWO_SIDED|95.0|-0.43|1.44|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.44|-0.43|0.2921
71863082|NCT01443403|143241078|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|STANDARD_ERROR_OF_MEAN|0.495||0.0039|TWO_SIDED|95.0|0.47|2.42|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.42|0.47|0.0039
71863083|NCT01443403|143241078|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.492||0.0007|TWO_SIDED|95.0|0.73|2.67|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.67|0.73|0.0007
71863084|NCT01443403|143241078|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.488||0.3077|TWO_SIDED|95.0|-0.46|1.46|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.46|-0.46|0.3077
71863085|NCT01443403|143241080|SUPERIORITY_OR_OTHER||Difference|27.3||||0.003|TWO_SIDED|95.0|10.0|44.6|||Chi-squared|||||44.6|10.0|0.0030
71863086|NCT01443403|143241080|SUPERIORITY_OR_OTHER||Difference|31.8||||0.0005|TWO_SIDED|95.0|15.0|48.7|||Chi-squared|||||48.7|15.0|0.0005
71863087|NCT01443403|143241080|SUPERIORITY_OR_OTHER||Difference|13.1||||0.1461|TWO_SIDED|95.0|-4.4|30.6|||Chi-squared|||||30.6|-4.4|0.1461
71863088|NCT01443403|143241082|SUPERIORITY_OR_OTHER||Difference|24.3||||0.005|TWO_SIDED|95.0|7.8|40.8|||Chi-squared|||||40.8|7.8|0.0050
71863089|NCT01443403|143241082|SUPERIORITY_OR_OTHER||Difference|24.5||||0.0045|TWO_SIDED|95.0|8.1|40.8|||Chi-squared|||||40.8|8.1|0.0045
71863090|NCT01443403|143241082|SUPERIORITY_OR_OTHER||Difference|8.2||||0.2984|TWO_SIDED|95.0|-7.2|23.6|||Chi-squared|||||23.6|-7.2|0.2984
71863091|NCT01443403|143241084|SUPERIORITY_OR_OTHER||LS Mean Difference|1.54|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|0.9|2.17|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.17|0.90|<0.0001
71863092|NCT01443403|143241084|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|0.32||0.0002|TWO_SIDED|95.0|0.59|1.85|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.85|0.59|0.0002
71863093|NCT01443403|143241084|SUPERIORITY_OR_OTHER||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.317||0.0698|TWO_SIDED|95.0|-0.05|1.2|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.20|-0.05|0.0698
71863094|NCT01443403|143241086|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|0.307||0.0001|TWO_SIDED|95.0|0.58|1.79|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.79|0.58|0.0001
71681749|NCT00793624|142881785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.137|0.219|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.219|0.137|<0.0001
71681750|NCT00793624|142881785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.129|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.211|0.129|<0.0001
71681751|NCT00793624|142881785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.144|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.144|<0.0001
71681752|NCT00793624|142881786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.145|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.103|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.103|<0.0001
71863095|NCT01443403|143241086|SUPERIORITY_OR_OTHER||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.305||0.0004|TWO_SIDED|95.0|0.49|1.7|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.70|0.49|0.0004
71863096|NCT01443403|143241086|SUPERIORITY_OR_OTHER||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.302||0.1648|TWO_SIDED|95.0|-0.17|1.02|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.02|-0.17|0.1648
71863097|NCT01443403|143241088|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0004
71863098|NCT01443403|143241088|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71863099|NCT01443403|143241088|SUPERIORITY_OR_OTHER|||||||0.0118||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0118
71863100|NCT01443403|143241089|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71863101|NCT01443403|143241089|SUPERIORITY_OR_OTHER|||||||0.0011||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0011
71863102|NCT01443403|143241089|SUPERIORITY_OR_OTHER|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
71863103|NCT01443403|143241092|SUPERIORITY_OR_OTHER||LS Mean Difference|1.33|STANDARD_ERROR_OF_MEAN|0.358||0.0003|TWO_SIDED|95.0|0.62|2.03|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.03|0.62|0.0003
71863104|NCT01443403|143241092|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|0.359|<|0.0001|TWO_SIDED|95.0|0.8|2.22|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||2.22|0.80|<0.0001
71863105|NCT01443403|143241092|SUPERIORITY_OR_OTHER||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.352||0.1211|TWO_SIDED|95.0|-0.15|1.24|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.24|-0.15|0.1211
71863106|NCT01443403|143241094|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|STANDARD_ERROR_OF_MEAN|0.551|<|0.0001|TWO_SIDED|95.0|1.28|3.45|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.45|1.28|<0.0001
71863107|NCT01443403|143241094|SUPERIORITY_OR_OTHER||LS Mean Difference|2.07|STANDARD_ERROR_OF_MEAN|0.549||0.0002|TWO_SIDED|95.0|0.99|3.15|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||3.15|0.99|0.0002
71863108|NCT01443403|143241094|SUPERIORITY_OR_OTHER||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.542||0.2022|TWO_SIDED|95.0|-0.37|1.76|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.||||1.76|-0.37|0.2022
71863109|NCT01443403|143241097|SUPERIORITY_OR_OTHER|||||||0.0272||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0272
71863110|NCT01443403|143241097|SUPERIORITY_OR_OTHER|||||||0.1355||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1355
71863111|NCT01443403|143241097|SUPERIORITY_OR_OTHER|||||||0.3689||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3689
71863112|NCT01443403|143241099|SUPERIORITY_OR_OTHER|||||||0.2126||95.0|||||Welch's t-test|||||||0.2126
71863113|NCT01443403|143241099|SUPERIORITY_OR_OTHER|||||||0.2799||95.0|||||Welch's t-test|||||||0.2799
71863114|NCT01443403|143241099|SUPERIORITY_OR_OTHER|||||||0.6466||95.0|||||Welch's t-test|||||||0.6466
71863115|NCT01443403|143241101|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Welch's t-test|||||||0.9826
71863116|NCT01443403|143241101|SUPERIORITY_OR_OTHER|||||||0.5188||95.0|||||Welch's t-test|||||||0.5188
71863117|NCT01443403|143241101|SUPERIORITY_OR_OTHER|||||||0.5029||95.0|||||Welch's t-test|||||||0.5029
71863118|NCT01681277|143241110|SUPERIORITY_OR_OTHER||Slope|1.2208|STANDARD_ERROR_OF_MEAN|0.1386|||TWO_SIDED|95.0|0.9354|1.5062|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.||1.5062|0.9354|
71863119|NCT01681277|143241112|SUPERIORITY_OR_OTHER||Slope|1.3135|STANDARD_ERROR_OF_MEAN|0.1206|||TWO_SIDED|95.0|1.0652|1.5618|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.||1.5618|1.0652|
71863120|NCT00474526|143241119|SUPERIORITY_OR_OTHER||Ratio of GMTs|4.53|||||TWO_SIDED|95.0|3.04|6.74|||ANOVA||A (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||6.74|3.04|
71863121|NCT00474526|143241119|SUPERIORITY_OR_OTHER||Ratio of GMTs|6.39|||||TWO_SIDED|95.0|4.16|9.79|||ANOVA||C (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||9.79|4.16|
71681753|NCT00793624|142881786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.105|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.188|0.105|<0.0001
71863122|NCT00474526|143241119|SUPERIORITY_OR_OTHER||Ratio of GMTs|37.0|||||TWO_SIDED|95.0|24.0|58.0|||ANOVA||W (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.||58|24|
71863123|NCT00474526|143241119|SUPERIORITY_OR_OTHER||Ratio of GMTs|38.0|||||TWO_SIDED|95.0|24.0|60.0|||ANOVA||Y (Post-vaccination GMT; group ratio US1A:US2)|"Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was \>= 2.0.~Ratio of GMTs"||60|24|
71863124|NCT00474526|143241128|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.55|0.95|||ANOVA|||Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)||0.95|0.55|
71863125|NCT00474526|143241128|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.81|1.31|||ANOVA|||Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)||1.31|0.81|
71863126|NCT00474526|143241128|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.42|||||TWO_SIDED|95.0|1.18|1.72|||ANOVA|||Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)||1.72|1.18|
71863127|NCT00474526|143241128|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be \> 0.5.|Ratio of GMTs|1.27|||||TWO_SIDED|95.0|1.02|1.58|||ANOVA|||Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)||1.58|1.02|
71863128|NCT00474526|143241131|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-15.0|||||TWO_SIDED|95.0|-21.2|-8.5|||ANOVA|||Serogroup A (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||-8.5|-21.2|
71863129|NCT00474526|143241131|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.3|||ANOVA|||Serogroup C (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||0.3|-7|
71863130|NCT00474526|143241131|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|1.0|||||TWO_SIDED|95.0|-1.3|3.1|||ANOVA|||Serogroup W (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||3.1|-1.3|
71863131|NCT00474526|143241131|NON_INFERIORITY_OR_EQUIVALENCE|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 - PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.7|||ANOVA|||Serogroup Y (post-vaccination percentage of subjects with hSBA titer \>=8, group difference (PLA1 - PLA3))||1.7|-4|
71863132|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.87|||||TWO_SIDED|95.0|0.74|1.04|||ANOVA|||Diphtheria (Post-vaccination GMT; group ratio US1:US2)||1.04|0.74|
71863133|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.08|||||TWO_SIDED|95.0|0.92|1.28|||ANOVA|||Tetanus (Post-vaccination GMT; group ratio US1:US2)||1.28|0.92|
71863134|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.79|1.26|||ANOVA|||PT (Post-vaccination GMT; group ratio US1:US2)||1.26|0.79|
71863135|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||FHA (Post-vaccination GMT; group ratio US1:US2)||1.25|0.85|
71681754|NCT00793624|142881786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.13|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.214|0.130|<0.0001
71863136|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.04|||||TWO_SIDED|95.0|0.83|1.32|||ANOVA|||Pertactin (Post-vaccination GMT; group ratio US1:US2||1.32|0.83|
71922093|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-8.05|STANDARD_ERROR_OF_MEAN|4.49|||TWO_SIDED|95.0|-17.36|1.25|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.25|-17.36|
71681755|NCT00793624|142881787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.048|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.126|0.048|<0.0001
71863137|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.96|||||TWO_SIDED|95.0|0.75|1.23|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)||1.23|0.75|
71863138|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.2|||||TWO_SIDED|95.0|0.93|1.55|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)||1.55|0.93|
71908749|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.2||0.1922|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1922
71908750|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2986|TWO_SIDED|95.0|-0.63|0.19|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.63|0.2986
71908751|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.21||0.2584|TWO_SIDED|95.0|-0.65|0.17|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.65|0.2584
71908752|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5195|TWO_SIDED|95.0|-0.57|0.29|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.29|-0.57|0.5195
71908753|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.21||0.3752|TWO_SIDED|95.0|-0.6|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.60|0.3752
71908754|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5157|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5157
71908755|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.5065|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5065
71863139|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.15|||||TWO_SIDED|95.0|0.85|1.56|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)||1.56|0.85|
71863140|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.88||||||95.0|0.65|1.2|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio US1:US2)||1.2|0.65|
71863141|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.31|||||TWO_SIDED|95.0|0.97|1.77|||ANOVA|||HIb (Post-vaccination GMT; group ratio US1:US2)||1.77|0.97|
71908756|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.21||0.8373|TWO_SIDED|95.0|-0.47|0.38|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.38|-0.47|0.8373
71908757|NCT02528253|143339065|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.22||0.5146|TWO_SIDED|95.0|-0.56|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.56|0.5146
71908758|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.16||0.0059|TWO_SIDED|95.0|-0.76|-0.13|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.76|0.0059
71908759|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.93|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-0.93|0.0002
71908760|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.15||0.0756|TWO_SIDED|95.0|-0.56|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.56|0.0756
71908761|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.2197|TWO_SIDED|95.0|-0.47|0.11|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.47|0.2197
71908762|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.15||0.0208|TWO_SIDED|95.0|-0.63|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.63|0.0208
71908763|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
71908764|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.08|-0.39|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.39|-1.08|<.0001
71908765|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1873|TWO_SIDED|95.0|-0.53|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.53|0.1873
71908766|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0305|TWO_SIDED|95.0|-0.66|-0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.66|0.0305
71908767|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0013|TWO_SIDED|95.0|-0.84|-0.2|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.20|-0.84|0.0013
71908768|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0158|TWO_SIDED|95.0|-0.78|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.08|-0.78|0.0158
71863142|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.84|||||TWO_SIDED|95.0|0.7|1.0|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio US1:US2)||1|0.7|
71908769|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.91|-0.21|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.21|-0.91|0.0015
71908770|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.16||0.4173|TWO_SIDED|95.0|-0.45|0.19|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.45|0.4173
71863143|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.56|1.03|||ANOVA|||PnC 6B (Post-vaccination GMT; group ratio US1:US2)||1.03|0.56|
71908771|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0659|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0659
71908772|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.74|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.74|0.0078
71908773|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.0737|TWO_SIDED|95.0|-0.72|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.03|-0.72|0.0737
71908774|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.19||0.0021|TWO_SIDED|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.97|0.0021
71908775|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.18||0.4535|TWO_SIDED|95.0|-0.48|0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.48|0.4535
71908776|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.18||0.2271|TWO_SIDED|95.0|-0.56|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.56|0.2271
71908777|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0086|TWO_SIDED|95.0|-0.81|-0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.12|-0.81|0.0086
71908778|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.2||0.2243|TWO_SIDED|95.0|-0.63|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.63|0.2243
71908779|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.0331|TWO_SIDED|95.0|-0.81|-0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.81|0.0331
71908780|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.2||0.1838|TWO_SIDED|95.0|-0.66|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.66|0.1838
71908781|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.2||0.0795|TWO_SIDED|95.0|-0.75|0.04|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.75|0.0795
71908782|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.21||0.2847|TWO_SIDED|95.0|-0.63|0.18|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.18|-0.63|0.2847
71681756|NCT00793624|142881787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.118|0.040|<0.0001
71908783|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0745|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0745
71681757|NCT00793624|142881787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
71681758|NCT00793624|142881788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.047|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.125|0.047|<0.0001
71908784|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.311|TWO_SIDED|95.0|-0.59|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.59|0.3110
71681759|NCT00793624|142881788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|STANDARD_ERROR_OF_MEAN|0.02||0.0001||95.0|0.038|0.117|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.117|0.038|0.0001
71681760|NCT00793624|142881788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.039|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.039|<0.0001
71681761|NCT00793624|142881789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.043|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|0.043|<0.0001
71908785|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1375|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.70|0.1375
71908786|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.21||0.4036|TWO_SIDED|95.0|-0.58|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.58|0.4036
71908787|NCT02528253|143339067|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0641|TWO_SIDED|95.0|-0.79|0.02|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.79|0.0641
71908788|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.85|0.0037
71908789|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0013|TWO_SIDED|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.22|-0.91|0.0013
71908790|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.16||0.1712|TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.53|0.1712
71908791|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.16||0.0686|TWO_SIDED|95.0|-0.6|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.60|0.0686
71908792|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0289|TWO_SIDED|95.0|-0.66|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.04|-0.66|0.0289
71908793|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.18||0.0003|TWO_SIDED|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.30|-1.02|0.0003
71908794|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.22|-0.49|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.49|-1.22|<.0001
71908795|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2056|TWO_SIDED|95.0|-0.55|0.12|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.12|-0.55|0.2056
71681762|NCT00793624|142881789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.02||0.0002||95.0|0.035|0.114|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.114|0.035|0.0002
71908796|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.17||0.0084|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.78|0.0084
71908797|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.17||0.0002|TWO_SIDED|95.0|-0.98|-0.31|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.31|-0.98|0.0002
71908798|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.0063|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.15|-0.90|0.0063
71908799|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.19||0.0002|TWO_SIDED|95.0|-1.09|-0.34|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.34|-1.09|0.0002
71908800|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1155|TWO_SIDED|95.0|-0.63|0.07|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.63|0.1155
71908801|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.18||0.1652|TWO_SIDED|95.0|-0.59|0.1|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.59|0.1652
71908802|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.18||0.0129|TWO_SIDED|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.78|0.0129
71908803|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.0236|TWO_SIDED|95.0|-0.87|-0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.06|-0.87|0.0236
71908804|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0136|TWO_SIDED|95.0|-0.93|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.93|0.0136
71908805|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6624|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.47|0.6624
71908806|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.19||0.0468|TWO_SIDED|95.0|-0.75|-0.01|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.01|-0.75|0.0468
71908807|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.19||0.025|TWO_SIDED|95.0|-0.81|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.05|-0.81|0.0250
71908808|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1539|TWO_SIDED|95.0|-0.72|0.11|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.11|-0.72|0.1539
71922094|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-8.28|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|-17.42|0.87|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.87|-17.42|
71922095|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-9.34|STANDARD_ERROR_OF_MEAN|4.86|||TWO_SIDED|95.0|-19.43|0.74|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.74|-19.43|
71922096|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-3.05|STANDARD_ERROR_OF_MEAN|4.77|||TWO_SIDED|95.0|-12.95|6.84|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||6.84|-12.95|
71922097|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-4.74|11.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||11.47|-4.74|
71863144|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.85||||||95.0|0.7|1.04|||ANOVA|||PnC 9V (Post-vaccination GMT; group ratio US1:US2)||1.04|0.7|
71863145|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.84|1.26|||ANOVA|||PnC 14 (Post-vaccination GMT; group ratio US1:US2)||1.26|0.84|
71863146|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.77|||||TWO_SIDED|95.0|0.64|0.93|||ANOVA|||PnC 18C (Post-vaccination GMT; group ratio US1:US2)||0.93|0.64|
71908809|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0169|TWO_SIDED|95.0|-0.91|-0.09|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.91|0.0169
71908810|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.21||0.1049|TWO_SIDED|95.0|-0.77|0.07|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.77|0.1049
71908811|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0599|TWO_SIDED|95.0|-0.82|0.02|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.82|0.0599
71908812|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.3041|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.3041
71908813|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0737|TWO_SIDED|95.0|-0.83|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.83|0.0737
71908814|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.23||0.2293|TWO_SIDED|95.0|-0.71|0.17|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.17|-0.71|0.2293
71681763|NCT00793624|142881789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.02||0.0037||95.0|0.019|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.100|0.019|0.0037
71908815|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.22||0.0806|TWO_SIDED|95.0|-0.82|0.05|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.05|-0.82|0.0806
71908816|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.368|TWO_SIDED|95.0|-0.62|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.23|-0.62|0.3680
71908817|NCT02528253|143339069|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.0893|TWO_SIDED|95.0|-0.79|0.06|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.||0.06|-0.79|0.0893
71908818|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.16||0.0007|TWO_SIDED|95.0|-0.88|-0.24|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.24|-0.88|0.0007
71908819|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.03|-0.38|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.38|-1.03|<.0001
71908820|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.15||0.1291|TWO_SIDED|95.0|-0.53|0.07|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.07|-0.53|0.1291
71908821|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.029|TWO_SIDED|95.0|-0.63|-0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.03|-0.63|0.0290
71908822|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.15||0.0015|TWO_SIDED|95.0|-0.77|-0.18|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.18|-0.77|0.0015
71908823|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.17|-0.87|0.0041
71908824|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.89|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.25|-0.54|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.54|-1.25|<.0001
71908825|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.1799|TWO_SIDED|95.0|-0.55|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.10|-0.55|0.1799
71908826|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0696|TWO_SIDED|95.0|-0.62|0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.02|-0.62|0.0696
71908827|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.35|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.35|-0.99|<.0001
71908828|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.18||0.0387|TWO_SIDED|95.0|-0.74|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.02|-0.74|0.0387
71681764|NCT00793624|142881790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.02||0.0016||95.0|0.025|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|0.025|0.0016
71908829|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.18||0.0005|TWO_SIDED|95.0|-1.0|-0.28|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.28|-1.00|0.0005
71908830|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.2768|TWO_SIDED|95.0|-0.51|0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.51|0.2768
71908831|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.2408|TWO_SIDED|95.0|-0.53|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.53|0.2408
71908832|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.17||0.0064|TWO_SIDED|95.0|-0.78|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.13|-0.78|0.0064
71908833|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.0115|TWO_SIDED|95.0|-0.9|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.11|-0.90|0.0115
71908834|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.2||0.0006|TWO_SIDED|95.0|-1.08|-0.29|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.29|-1.08|0.0006
71908835|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.2028|TWO_SIDED|95.0|-0.59|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.13|-0.59|0.2028
71908836|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.1351|TWO_SIDED|95.0|-0.64|0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.09|-0.64|0.1351
71908837|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.18||0.0133|TWO_SIDED|95.0|-0.82|-0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||-0.09|-0.82|0.0133
71908838|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.2||0.2157|TWO_SIDED|95.0|-0.65|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.15|-0.65|0.2157
71908839|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.2||0.0781|TWO_SIDED|95.0|-0.76|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.04|-0.76|0.0781
71908840|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3527|TWO_SIDED|95.0|-0.62|0.22|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.22|-0.62|0.3527
71681765|NCT00793624|142881790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.02||0.0276||95.0|0.005|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.005|0.0276
71908841|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.22||0.2994|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.20|-0.65|0.2994
71908842|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.22||0.3326|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.21|-0.63|0.3326
71908843|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.2822|TWO_SIDED|95.0|-0.65|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.65|0.2822
71908844|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.22||0.4932|TWO_SIDED|95.0|-0.57|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.28|-0.57|0.4932
71908845|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.22||0.4571|TWO_SIDED|95.0|-0.58|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.26|-0.58|0.4571
71908846|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.22||0.5586|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.30|-0.56|0.5586
71908847|NCT02528253|143339071|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.22||0.2664|TWO_SIDED|95.0|-0.67|0.19|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.||0.19|-0.67|0.2664
71908848|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|2.14||||0.001|TWO_SIDED|95.0|1.36|3.36|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.36|1.36|0.0010
71908849|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|2.68|||<|0.0001|TWO_SIDED|95.0|1.73|4.16|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||4.16|1.73|<.0001
71908850|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.62||||0.03|TWO_SIDED|95.0|1.05|2.51|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.51|1.05|0.0300
71908851|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|2.03|||<|0.0001|TWO_SIDED|95.0|1.44|2.86|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.86|1.44|<.0001
71908852|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|2.37|||<|0.0001|TWO_SIDED|95.0|1.69|3.32|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.32|1.69|<.0001
71908853|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.44||||0.029|TWO_SIDED|95.0|1.04|1.99|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.99|1.04|0.0290
71908854|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.8||||0.0003|TWO_SIDED|95.0|1.31|2.47|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.47|1.31|0.0003
71908855|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.62|3.03|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||3.03|1.62|<.0001
71908856|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0033|TWO_SIDED|95.0|1.16|2.1|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.10|1.16|0.0033
71908857|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0179|TWO_SIDED|95.0|1.06|1.88|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.88|1.06|0.0179
71908858|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.56||||0.0021|TWO_SIDED|95.0|1.18|2.08|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||2.08|1.18|0.0021
71908859|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.06||||0.6629|TWO_SIDED|95.0|0.81|1.38|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.38|0.81|0.6629
71908860|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.35||||0.0251|TWO_SIDED|95.0|1.04|1.75|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.75|1.04|0.0251
71908861|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.22||||0.1278|TWO_SIDED|95.0|0.94|1.59|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.59|0.94|0.1278
71908862|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.27||||0.0749|TWO_SIDED|95.0|0.98|1.65|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.65|0.98|0.0749
71908863|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0633|TWO_SIDED|95.0|0.99|1.66|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.66|0.99|0.0633
71908864|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.28||||0.0626|TWO_SIDED|95.0|0.99|1.67|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.67|0.99|0.0626
71908865|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.16||||0.2727|TWO_SIDED|95.0|0.89|1.51|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.51|0.89|0.2727
71908866|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.2||||0.1749|TWO_SIDED|95.0|0.92|1.57|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.57|0.92|0.1749
71908867|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.09||||0.5239|TWO_SIDED|95.0|0.84|1.42|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.42|0.84|0.5239
71908868|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.14||||0.3336|TWO_SIDED|95.0|0.87|1.49|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.49|0.87|0.3336
71908869|NCT02528253|143339073|SUPERIORITY||Odds Ratio (OR)|1.18||||0.2163|TWO_SIDED|95.0|0.91|1.54|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.||1.54|0.91|0.2163
71908870|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.28||||0.326|TWO_SIDED|95.0|0.78|2.08|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.08|0.78|0.3260
71908871|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0445|TWO_SIDED|95.0|1.01|2.56|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.56|1.01|0.0445
71908872|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9263|TWO_SIDED|95.0|0.65|1.61|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.61|0.65|0.9263
71908873|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.25||||0.3194|TWO_SIDED|95.0|0.81|1.94|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.81|0.3194
71863147|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.82|||||TWO_SIDED|95.0|0.69|0.97|||ANOVA|||PnC 19F (Post-vaccination GMT; group ratio US1:US2)||0.97|0.69|
71863148|NCT00474526|143241133|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.79|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 23F (Post-vaccination GMT; group ratio US1:US2)||1.02|0.62|
71863149|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Diphtheria (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
71863150|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Tetanus (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
71863151|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-7.0|12.0|||ANOVA|||PT (Seroconversion percentage difference (PUS1 - PUS2))||12|-7|
71863152|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|6.0|||||TWO_SIDED|95.0|-4.0|17.0|||ANOVA|||FHA(Seroconversion percentage difference (PUS1 - PUS2))||17|-4|
71863153|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-12.0|10.0|||ANOVA|||Pertactin (Seroconversion percentage difference (PUS1 - PUS2))||10|-12|
71863154|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
71863155|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.0|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PUS1 - PUS2))||4|-2|
71863156|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
71863157|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||Hepatitis B(Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
71863158|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||3|-3|
71863159|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|5.0|||||TWO_SIDED|95.0|-3.0|14.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 - PUS2))||14|-3|
71863160|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.0|2.0|||ANOVA|||PnC 4(Seroconversion percentage difference (PUS1 - PUS2))||2|-5|
71863161|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-8.0|||||TWO_SIDED|95.0|-14.0|-1.0|||ANOVA|||PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))||-1|-14|
71863162|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-4.0|5.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PUS1 - PUS2))||5|-4|
71863163|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Diphtheria (Seroconversion percentage di|1.0|||||TWO_SIDED|95.0|-1.0|5.0|||ANOVA|||PnC 14 (Seroconversion percentage difference (PUS1 - PUS2))||5|-1|
71863164|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-6.0|1.0|||ANOVA|||PnC 18C (Seroconversion percentage difference (PUS1 - PUS2))||1|-6|
71681766|NCT00793624|142881790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.021||0.0426||95.0|0.001|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.082|0.001|0.0426
71681767|NCT00793624|142881791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0237||95.0|0.006|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.087|0.006|0.0237
71681768|NCT00793624|142881791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.049|STANDARD_ERROR_OF_MEAN|0.021||0.0175||95.0|0.009|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.090|0.009|0.0175
71681769|NCT00793624|142881791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.021||0.0339||95.0|0.003|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.085|0.003|0.0339
71681770|NCT00793624|142881792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.021||0.0537||95.0|-0.001|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.081|-0.001|0.0537
71908874|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.58||||0.0308|TWO_SIDED|95.0|1.04|2.38|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.38|1.04|0.0308
71908875|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0048|TWO_SIDED|95.0|1.2|2.69|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.69|1.20|0.0048
71908876|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.68||||0.0114|TWO_SIDED|95.0|1.12|2.51|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.51|1.12|0.0114
71908877|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7857|TWO_SIDED|95.0|0.71|1.56|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.71|0.7857
71908878|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.7||||0.0041|TWO_SIDED|95.0|1.18|2.44|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.44|1.18|0.0041
71908879|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.59||||0.0109|TWO_SIDED|95.0|1.11|2.28|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.28|1.11|0.0109
71908880|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.53||||0.0363|TWO_SIDED|95.0|1.03|2.27|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.27|1.03|0.0363
71908881|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.76||||0.004|TWO_SIDED|95.0|1.2|2.59|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.59|1.20|0.0040
71908882|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.27||||0.1992|TWO_SIDED|95.0|0.88|1.84|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.84|0.88|0.1992
71908883|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3084|TWO_SIDED|95.0|0.85|1.7|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.70|0.85|0.3084
71908884|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.38||||0.0586|TWO_SIDED|95.0|0.99|1.94|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.94|0.99|0.0586
71908885|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.39||||0.063|TWO_SIDED|95.0|0.98|1.97|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.97|0.98|0.0630
71681771|NCT00793624|142881792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.021||0.0808||95.0|-0.004|0.078|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.078|-0.004|0.0808
71681772|NCT00793624|142881792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.021||0.2579||95.0|-0.017|0.065|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.065|-0.017|0.2579
71908886|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0347|TWO_SIDED|95.0|1.03|2.04|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.04|1.03|0.0347
71908887|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|0.96||||0.79|TWO_SIDED|95.0|0.69|1.33|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.33|0.69|0.7900
71908888|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.45||||0.0207|TWO_SIDED|95.0|1.06|2.0|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.00|1.06|0.0207
71908889|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0093|TWO_SIDED|95.0|1.11|2.07|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.07|1.11|0.0093
71908890|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.39||||0.04|TWO_SIDED|95.0|1.02|1.91|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.91|1.02|0.0400
71908891|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.21||||0.2478|TWO_SIDED|95.0|0.88|1.65|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.65|0.88|0.2478
71908892|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0304|TWO_SIDED|95.0|1.03|1.96|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.96|1.03|0.0304
71908893|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.12||||0.4763|TWO_SIDED|95.0|0.81|1.56|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.56|0.81|0.4763
71908894|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0178|TWO_SIDED|95.0|1.07|2.01|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||2.01|1.07|0.0178
71908895|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5223|TWO_SIDED|95.0|0.8|1.53|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.53|0.80|0.5223
71908896|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.25||||0.1708|TWO_SIDED|95.0|0.91|1.72|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.72|0.91|0.1708
71908897|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6022|TWO_SIDED|95.0|0.79|1.5|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.50|0.79|0.6022
71908898|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.32||||0.0846|TWO_SIDED|95.0|0.96|1.81|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.81|0.96|0.0846
71908899|NCT02528253|143339074|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9626|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.||1.39|0.73|0.9626
71908900|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.64||0.6508|TWO_SIDED|95.0|-2.49|3.98|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.98|-2.49|0.6508
71908901|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|1.66||0.9629|TWO_SIDED|95.0|-3.33|3.18|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.18|-3.33|0.9629
71908902|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.57||0.7007|TWO_SIDED|95.0|-2.48|3.69|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.69|-2.48|0.7007
71908903|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|1.58||0.8902|TWO_SIDED|95.0|-3.32|2.88|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.88|-3.32|0.8902
71908904|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.53||0.5698|TWO_SIDED|95.0|-3.89|2.15|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.15|-3.89|0.5698
71908905|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.8464|TWO_SIDED|95.0|-3.32|2.72|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.72|-3.32|0.8464
71908906|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-4.03|STANDARD_ERROR_OF_MEAN|2.39||0.0919|TWO_SIDED|95.0|-8.72|0.66|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.66|-8.72|0.0919
71908907|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|2.4||0.0477|TWO_SIDED|95.0|-9.47|-0.05|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.05|-9.47|0.0477
71908908|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-1.65|STANDARD_ERROR_OF_MEAN|2.3||0.4735|TWO_SIDED|95.0|-6.17|2.87|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.87|-6.17|0.4735
71908909|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-2.38|STANDARD_ERROR_OF_MEAN|2.26||0.2935|TWO_SIDED|95.0|-6.82|2.06|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.06|-6.82|0.2935
71908910|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-3.11|STANDARD_ERROR_OF_MEAN|2.27||0.1714|TWO_SIDED|95.0|-7.56|1.35|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.35|-7.56|0.1714
71908911|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|2.75||0.7521|TWO_SIDED|95.0|-6.3|4.56|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||4.56|-6.30|0.7521
71908912|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|2.75||0.3078|TWO_SIDED|95.0|-8.24|2.61|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.61|-8.24|0.3078
71908913|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-3.95|STANDARD_ERROR_OF_MEAN|2.46||0.109|TWO_SIDED|95.0|-8.78|0.88|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.88|-8.78|0.1090
71908914|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-5.41|STANDARD_ERROR_OF_MEAN|2.47||0.0289|TWO_SIDED|95.0|-10.27|-0.56|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.56|-10.27|0.0289
71908915|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.37||0.4613|TWO_SIDED|95.0|-6.41|2.91|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.91|-6.41|0.4613
71681773|NCT00793624|142881793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.021||0.0011||95.0|0.027|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.109|0.027|0.0011
71681774|NCT00793624|142881793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.021||0.0069||95.0|0.018|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.018|0.0069
71908916|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|2.33||0.346|TWO_SIDED|95.0|-6.78|2.38|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.38|-6.78|0.3460
71908917|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|2.34||0.1179|TWO_SIDED|95.0|-8.26|0.93|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.93|-8.26|0.1179
71681775|NCT00793624|142881793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.119|0.040|<0.0001
71681776|NCT00793624|142881794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.135|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.220|0.135|<0.0001
71908918|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-1.93|STANDARD_ERROR_OF_MEAN|2.97||0.5151|TWO_SIDED|95.0|-7.78|3.92|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.92|-7.78|0.5151
71908919|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|2.96||0.255|TWO_SIDED|95.0|-9.22|2.46|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.46|-9.22|0.2550
71908920|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0157|TWO_SIDED|95.0|-7.57|-0.79|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.79|-7.57|0.0157
71908921|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-4.18|STANDARD_ERROR_OF_MEAN|1.73||0.0159|TWO_SIDED|95.0|-7.57|-0.78|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||-0.78|-7.57|0.0159
71908922|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.62||0.0896|TWO_SIDED|95.0|-5.94|0.43|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||0.43|-5.94|0.0896
71908923|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.6||0.3749|TWO_SIDED|95.0|-4.57|1.72|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.72|-4.57|0.3749
71908924|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-1.42|STANDARD_ERROR_OF_MEAN|1.59||0.3733|TWO_SIDED|95.0|-4.55|1.71|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||1.71|-4.55|0.3733
71908925|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|2.17||0.8056|TWO_SIDED|95.0|-4.8|3.73|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||3.73|-4.80|0.8056
71908926|NCT02528253|143339078|SUPERIORITY||LS Mean Difference|-1.16|STANDARD_ERROR_OF_MEAN|2.08||0.5764|TWO_SIDED|95.0|-5.25|2.93|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.||2.93|-5.25|0.5764
71908927|NCT02528253|143339079|SUPERIORITY||Odds Ratio (OR)|0.93||||0.7366|TWO_SIDED|95.0|0.62|1.41|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.41|0.62|0.7366
71908928|NCT02528253|143339079|SUPERIORITY||Odds Ratio (OR)|1.06||||0.771|TWO_SIDED|95.0|0.71|1.58|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.||1.58|0.71|0.7710
71908929|NCT02528253|143339080|SUPERIORITY|||||||0.4724|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.4724
71908930|NCT02528253|143339080|SUPERIORITY|||||||0.7142|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.||||0.7142
71908931|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.12||||0.396|TWO_SIDED|95.0|0.87|1.44|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.87|0.3960
71908932|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.93||||0.5932|TWO_SIDED|95.0|0.73|1.2|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.20|0.73|0.5932
71908933|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.13||||0.3326|TWO_SIDED|95.0|0.88|1.46|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.46|0.88|0.3326
71908934|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.84||||0.1765|TWO_SIDED|95.0|0.65|1.08|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.08|0.65|0.1765
71908935|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5619|TWO_SIDED|95.0|0.84|1.39|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.39|0.84|0.5619
71908936|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.89||||0.3909|TWO_SIDED|95.0|0.69|1.16|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.16|0.69|0.3909
71908937|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7562|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7562
71908938|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9476|TWO_SIDED|95.0|0.78|1.31|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.31|0.78|0.9476
71908939|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7746|TWO_SIDED|95.0|0.79|1.36|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.36|0.79|0.7746
71908940|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.94||||0.6377|TWO_SIDED|95.0|0.71|1.23|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.23|0.71|0.6377
71908941|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8532|TWO_SIDED|95.0|0.79|1.33|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.79|0.8532
71681777|NCT00793624|142881794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.108|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.108|<0.0001
71908942|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.08||||0.5644|TWO_SIDED|95.0|0.83|1.4|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.40|0.83|0.5644
71908943|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.04||||0.769|TWO_SIDED|0.769|0.8|1.35|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7690
71908944|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.11||||0.4321|TWO_SIDED|95.0|0.85|1.44|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.44|0.85|0.4321
71908945|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.04||||0.7714|TWO_SIDED|95.0|0.8|1.35|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.35|0.80|0.7714
71908946|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.03||||0.8389|TWO_SIDED|95.0|0.79|1.34|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.34|0.79|0.8389
71908947|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9383|TWO_SIDED|95.0|0.76|1.29|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.29|0.76|0.9383
71908948|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|1.02||||0.88|TWO_SIDED|95.0|0.78|1.33|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.33|0.78|0.8800
71908949|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.97||||0.7946|TWO_SIDED|95.0|0.74|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.26|0.74|0.7946
71908950|NCT02528253|143339081|SUPERIORITY||Odds Ratio (OR)|0.96||||0.7803|TWO_SIDED|95.0|0.74|1.25|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.||1.25|0.74|0.7803
71908951|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.16|STANDARD_ERROR_OF_MEAN|0.11||0.1272|TWO_SIDED|95.0|0.96|1.41|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.41|0.96|0.1272
71908952|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.1||0.6322|TWO_SIDED|95.0|0.86|1.27|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.86|0.6322
71908953|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.12||0.3559|TWO_SIDED|95.0|0.89|1.36|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.36|0.89|0.3559
71908954|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.96||||0.6798|TWO_SIDED|95.0|0.77|1.18|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.18|0.77|0.6798
71908955|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.14||||0.267|TWO_SIDED|95.0|0.9|1.44|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.44|0.90|0.2670
71908956|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.94||||0.5865|TWO_SIDED|95.0|0.74|1.19|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.19|0.74|0.5865
71908957|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.13||||0.3378|TWO_SIDED|95.0|0.88|1.47|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.47|0.88|0.3378
71908958|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.92||||0.551|TWO_SIDED|95.0|0.71|1.2|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.71|0.5510
71908959|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.2|STANDARD_ERROR_OF_MEAN|0.18||0.2088|TWO_SIDED|95.0|0.9|1.6|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.90|0.2088
71908960|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8692|TWO_SIDED|95.0|0.73|1.3|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.30|0.73|0.8692
71908961|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.03|STANDARD_ERROR_OF_MEAN|0.14||0.8444|TWO_SIDED|95.0|0.78|1.35|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.35|0.78|0.8444
71908962|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8936|TWO_SIDED|95.0|0.78|1.34|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.78|0.8936
71908963|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8716|TWO_SIDED|95.0|0.75|1.28|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.28|0.75|0.8716
71908964|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14||0.8827|TWO_SIDED|95.0|0.75|1.29|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.29|0.75|0.8827
71908965|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.14||0.8996|TWO_SIDED|95.0|0.77|1.34|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.34|0.77|0.8996
71908966|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.488|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.4880
71908967|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.14||0.7938|TWO_SIDED|95.0|0.73|1.27|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.27|0.73|0.7938
71908968|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.91|STANDARD_ERROR_OF_MEAN|0.13||0.5092|TWO_SIDED|95.0|0.69|1.2|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.20|0.69|0.5092
71908969|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.13||0.6148|TWO_SIDED|95.0|0.71|1.22|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.22|0.71|0.6148
71908970|NCT02528253|143339083|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.12||0.2844|TWO_SIDED|95.0|0.66|1.13|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.13|0.66|0.2844
71908971|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.1|STANDARD_ERROR_OF_MEAN|0.25||0.6764|TWO_SIDED|95.0|0.7|1.73|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.73|0.70|0.6764
71681778|NCT00793624|142881794|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.148|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.233|0.148|<0.0001
71681779|NCT00793624|142881795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.124|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.124|<0.0001
71908972|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.23||0.9351|TWO_SIDED|95.0|0.65|1.6|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.65|0.9351
71908973|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.97|STANDARD_ERROR_OF_MEAN|0.2||0.8731|TWO_SIDED|95.0|0.64|1.46|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.64|0.8731
71908974|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.14|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|0.75|1.72|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.72|0.75|0.5370
71908975|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.22||0.8031|TWO_SIDED|95.0|0.7|1.59|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.59|0.70|0.8031
71908976|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.24||0.8192|TWO_SIDED|95.0|0.57|1.55|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.55|0.57|0.8192
71908977|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.22||0.6345|TWO_SIDED|95.0|0.54|1.46|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.54|0.6345
71908978|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.89|STANDARD_ERROR_OF_MEAN|0.21||0.6103|TWO_SIDED|95.0|0.56|1.4|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.40|0.56|0.6103
71908979|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.25||0.7949|TWO_SIDED|95.0|0.67|1.67|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.67|0.7949
71908980|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.23||0.992|TWO_SIDED|95.0|0.63|1.57|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.57|0.63|0.9920
71908981|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.27||0.8772|TWO_SIDED|95.0|0.55|1.67|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.67|0.55|0.8772
71908982|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7614|TWO_SIDED|95.0|0.53|1.6|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.60|0.53|0.7614
71908983|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.22||0.5629|TWO_SIDED|95.0|0.52|1.43|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.43|0.52|0.5629
71908984|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.29||0.6821|TWO_SIDED|95.0|0.67|1.85|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.85|0.67|0.6821
71908985|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.28||0.8049|TWO_SIDED|95.0|0.64|1.77|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.77|0.64|0.8049
71908986|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.87|STANDARD_ERROR_OF_MEAN|0.27||0.6673|TWO_SIDED|95.0|0.47|1.62|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.62|0.47|0.6673
71908987|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.79|STANDARD_ERROR_OF_MEAN|0.25||0.4475|TWO_SIDED|95.0|0.43|1.46|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.46|0.43|0.4475
71908988|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.86|STANDARD_ERROR_OF_MEAN|0.25||0.5925|TWO_SIDED|95.0|0.49|1.5|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.50|0.49|0.5925
71908989|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.29||0.9486|TWO_SIDED|95.0|0.58|1.79|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.79|0.58|0.9486
71908990|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.7673|TWO_SIDED|95.0|0.52|1.61|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.61|0.52|0.7673
71908991|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.11|STANDARD_ERROR_OF_MEAN|0.39||0.7635|TWO_SIDED|95.0|0.56|2.2|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.20|0.56|0.7635
71908992|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.98|STANDARD_ERROR_OF_MEAN|0.34||0.9564|TWO_SIDED|95.0|0.5|1.94|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.94|0.50|0.9564
71908993|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.3||0.8359|TWO_SIDED|95.0|0.5|1.75|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.75|0.50|0.8359
71908994|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.19|STANDARD_ERROR_OF_MEAN|0.38||0.5914|TWO_SIDED|95.0|0.64|2.21|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||2.21|0.64|0.5914
71908995|NCT02528253|143339085|SUPERIORITY||LS Mean Ratio|1.05|STANDARD_ERROR_OF_MEAN|0.33||0.8826|TWO_SIDED|95.0|0.56|1.95|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.||1.95|0.56|0.8826
71908996|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|7.02|STANDARD_ERROR_OF_MEAN|2.01||0.0005|TWO_SIDED|95.0|3.07|10.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.97|3.07|0.0005
71908997|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|6.21|STANDARD_ERROR_OF_MEAN|2.01||0.0021|TWO_SIDED|95.0|2.26|10.15|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||10.15|2.26|0.0021
71908998|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|4.72|STANDARD_ERROR_OF_MEAN|1.89||0.0125|TWO_SIDED|95.0|1.02|8.42|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.42|1.02|0.0125
71908999|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.87||0.2176|TWO_SIDED|95.0|-1.36|5.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|-1.36|0.2176
71909000|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|1.86||0.4235|TWO_SIDED|95.0|-2.16|5.14|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.14|-2.16|0.4235
71909001|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.96||0.0143|TWO_SIDED|95.0|2.5|22.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.11|2.50|0.0143
71909002|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|12.55|STANDARD_ERROR_OF_MEAN|4.96||0.0124|TWO_SIDED|95.0|2.76|22.35|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||22.35|2.76|0.0124
71909003|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|3.88|STANDARD_ERROR_OF_MEAN|4.29||0.3675|TWO_SIDED|95.0|-4.6|12.36|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||12.36|-4.60|0.3675
71909004|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|8.42|STANDARD_ERROR_OF_MEAN|3.89||0.0319|TWO_SIDED|95.0|0.74|16.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.11|0.74|0.0319
71909005|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|8.67|STANDARD_ERROR_OF_MEAN|3.9||0.0276|TWO_SIDED|95.0|0.97|16.38|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.38|0.97|0.0276
71909006|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|1.38||0.0627|TWO_SIDED|95.0|-0.14|5.27|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.27|-0.14|0.0627
71909007|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|3.26|STANDARD_ERROR_OF_MEAN|1.38||0.0187|TWO_SIDED|95.0|0.54|5.97|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.97|0.54|0.0187
71909008|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.3||0.2419|TWO_SIDED|95.0|-1.03|4.06|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.06|-1.03|0.2419
71909009|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|1.28||0.4124|TWO_SIDED|95.0|-1.46|3.56|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||3.56|-1.46|0.4124
71909010|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|1.27||0.173|TWO_SIDED|95.0|-0.76|4.24|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.24|-0.76|0.1730
71909011|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|5.42|STANDARD_ERROR_OF_MEAN|1.86||0.0037|TWO_SIDED|95.0|1.77|9.08|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||9.08|1.77|0.0037
71909012|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|3.74|STANDARD_ERROR_OF_MEAN|1.86||0.0449|TWO_SIDED|95.0|0.09|7.39|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||7.39|0.09|0.0449
71909013|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|1.75||0.2038|TWO_SIDED|95.0|-1.21|5.65|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.65|-1.21|0.2038
71909014|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.73||0.0644|TWO_SIDED|95.0|-0.19|6.59|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.59|-0.19|0.0644
71909015|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.52|STANDARD_ERROR_OF_MEAN|1.72||0.3775|TWO_SIDED|95.0|-1.86|4.9|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.90|-1.86|0.3775
71909016|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.62||0.5806|TWO_SIDED|95.0|-3.7|6.6|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.60|-3.70|0.5806
71909017|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|2.53||0.6084|TWO_SIDED|95.0|-3.68|6.27|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||6.27|-3.68|0.6084
71909018|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|6.95||0.6991|TWO_SIDED|95.0|-11.56|16.99|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||16.99|-11.56|0.6991
71909019|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|13.17|STANDARD_ERROR_OF_MEAN|5.6||0.0265|TWO_SIDED|95.0|1.66|24.68|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||24.68|1.66|0.0265
71909020|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|1.99||0.8795|TWO_SIDED|95.0|-3.61|4.21|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||4.21|-3.61|0.8795
71909021|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.92||0.2758|TWO_SIDED|95.0|-1.68|5.87|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||5.87|-1.68|0.2758
71909022|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|3.54|STANDARD_ERROR_OF_MEAN|2.27||0.1197|TWO_SIDED|95.0|-0.92|8.0|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.00|-0.92|0.1197
71909023|NCT02528253|143339094|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.19||0.0743|TWO_SIDED|95.0|-0.39|8.24|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.||8.24|-0.39|0.0743
71909024|NCT04507776|143339113|OTHER|||||||0.75|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.75
71909025|NCT04507776|143339113|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
71909026|NCT04507776|143339113|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||<0.05
71909027|NCT04507776|143339113|OTHER|||||||0.43|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.43
71863165|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-1.0|||||TWO_SIDED|95.0|-4.0|3.0|||ANOVA|||PnC 19F (Seroconversion percentage difference (PUS1 - PUS2))||3|-4|
71863166|NCT00474526|143241134|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 - PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PUS1 - PUS2))||5|-8|
71863167|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.16|||||TWO_SIDED|95.0|0.96|1.4|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.96|
71909028|NCT04507776|143339114|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
71909029|NCT04507776|143339114|OTHER|||||||0.247|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.247
71909030|NCT04507776|143339115|OTHER|||||||0.21|||||||t-test, 2 sided|||Year 1 Adherence: Baseline||||0.21
71909031|NCT04507776|143339115|OTHER||||||<|0.05|||||||t-test, 2 sided|||Year 1 Adherence: Year 1 (Month 12)||||<0.05
71909032|NCT04507776|143339115|OTHER|||||||0.62|||||||t-test, 2 sided|||Year 7 Adherence: Baseline||||0.62
71909033|NCT04507776|143339115|OTHER|||||||0.18|||||||t-test, 2 sided|||Year 7 Adherence: Year 7||||0.18
71909034|NCT04507776|143339116|OTHER|||||||0.0001|||||||t-test, 2 sided|||Year 1 Adherence: Change at Year 1 (Month 12)||||0.0001
71909035|NCT04507776|143339116|OTHER|||||||0.003|||||||t-test, 2 sided|||Year 7 Adherence: Change at Year 7||||0.003
71863168|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.1|||||TWO_SIDED|95.0|0.96|1.27|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.96|
71909036|NCT00962754|143339119|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority since our hypothesis was that there would be no difference in outcome between the intervention and the control group.|Adjusted ratio of geometric means|1.0|||<|0.05|TWO_SIDED|95.0|0.81|1.19||"log transformation of mean duration of hospitalization,difference between two groups expressed as ratio of geometric means for duration. 95% confidence intervals calculated using bootstrapping method.~correction by linear regression model"|t-test, 2 sided|||We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.||1.19|0.81|<0.05
71909037|NCT00132314|143339122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.39|TWO_SIDED|95.0|0.63|1.2|||Log Rank|||Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.||1.20|0.63|0.39
71909038|NCT00132314|143339123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.63|1.2||95% Confidence Interval: 0.63 to 1.20|Regression, Cox|||||1.20|0.63|
71863169|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.04|||||TWO_SIDED|95.0|0.87|1.25|||ANOVA|||PT (Post-vaccination GMC; group ratio LA1:LA2)||1.25|0.87|
71909039|NCT02514772|143339136|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
71909040|NCT02514772|143339137|OTHER||Difference (%)|-1.7|||||TWO_SIDED|95.0|-20.6|16.9||||||||16.9|-20.6|
71909041|NCT02514772|143339138|OTHER||Difference (%)|-1.9|||||TWO_SIDED|95.0|-21.2|17.6||||||||17.6|-21.2|
71909042|NCT02514772|143339139|OTHER||Mean Difference (Final Values)|-5.4|||||TWO_SIDED|95.0|-24.2|13.3||||||Incidence difference of infusion-related reactions, occurred on day of or on day after first infusion (i.e. on study day 1 or on study day 2).||13.3|-24.2|
71909043|NCT02514772|143339139|OTHER||Mean Difference (Final Values)|-5.3|||||TWO_SIDED|95.0|-24.5|13.6||||||Incidence difference of infusion-related reactions, occurred on day of or on day after second infusion (i.e. on study day 14 or on study day 15).||13.6|-24.5|
71909044|NCT02514772|143339139|OTHER||Mean Difference (Final Values)|-7.2|||||TWO_SIDED|95.0|-26.0|11.4||||||Incidence difference of infusion-related reactions overall on day(s) of or day(s) after either infusion (i.e. on day 1 or 2 and on day 14 or day 15).||11.4|-26.0|
71909045|NCT00698035|143339185|SUPERIORITY_OR_OTHER||||||>|0.05||||||Significant at p\<0.05|t-test, 2 sided|||Comparison of baseline estradiol between LC/MS and RIA||||>0.05
71909046|NCT00698035|143339185|SUPERIORITY_OR_OTHER||||||>|0.05||||||singificant at p\<0.05|t-test, 2 sided|||Comparison of week 4 estradiol between LC/MS and RIA||||>0.05
71909047|NCT00698035|143339188|SUPERIORITY_OR_OTHER|||||||0.021||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.021
71909048|NCT00698035|143339188|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
71909049|NCT00698035|143339188|SUPERIORITY_OR_OTHER|||||||0.0228||||||Significant at p\<0.05|t-test, 2 sided|||Change in SI from BL to W12||||0.0228
71909050|NCT00698035|143339188|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Change in SD from BL to W12||||<0.001
71909051|NCT00698035|143339189|SUPERIORITY_OR_OTHER|||||||0.004||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.004
71909052|NCT00698035|143339189|SUPERIORITY_OR_OTHER|||||||0.139||||||Significant at p\<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12||||0.139
71909053|NCT00698035|143339190|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12||||<0.001
71909054|NCT00698035|143339190|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significant at p\<0.05|t-test, 2 sided|||Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks||||<0.001
71909055|NCT00698035|143339190|SUPERIORITY_OR_OTHER|||||||0.0061||||||Significant at p\<0.05|t-test, 2 sided|||Difference in petechiae between baseline and week 12||||0.0061
71909056|NCT03657810|143339191|SUPERIORITY||||||<|0.001|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator.|Regression, Logistic|||||||<0.001
71909057|NCT03657810|143339192|SUPERIORITY|||||||0.052|TWO_SIDED|95.0||||Type III P-Value are from the likelihood ration test from the logistic regression model with factors of treatment, gender, and investigator|Regression, Logistic|||||||0.052
71909058|NCT04426890|143339200|EQUIVALENCE|Therapeutic equivalence was declared if the two-sided 90% confidence interval (CI) for the treatment difference was entirely within an equivalence margin of \[-2.5, 2.0\].|Mean Difference (Net)|0.7|||||TWO_SIDED|90.0|-0.22|1.63||||||The statistical analysis of mean change from baseline in ISS7 at Week 12 between CT-P39 300 mg treatment arm (Arm 1) and Xolair 300 mg treatment arm (Arm 2), using ANCOVA with multiple imputation based on the MAR assumption was performed for the mITT Set.||1.63|-0.22|
71909059|NCT01082367|143339259|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55|||<|0.001|TWO_SIDED|95.0|4.67|99.52|||Regression, Logistic|||||99.52|4.67|<0.001
71909060|NCT02016898|143339262|OTHER||Risk Ratio (RR)|0.93||||0.7|TWO_SIDED|95.0|0.67|1.29|||Chi-squared|||||1.29|0.67|0.7
71909061|NCT02016898|143339263|OTHER||Median Difference (Final Values)|0.2|STANDARD_DEVIATION|2.01||0.539|TWO_SIDED||||||t-test, 1 sided|||||||0.539
71909062|NCT02151682|143339280|NON_INFERIORITY|A logistic regression model was fitted to the response using baseline pain, age group, treatment, and underlying pain condition as explanatory variables, followed by a Farrington-Manning test for non-inferiority, based on Full Analysis Set.|Risk Difference (RD)|-0.06||||0.079|TWO_SIDED|80.0|-0.19|0.06||The p-value is based on Farrington-Manning variance estimator using a pre-specified non-inferiority margin of -0.2. A 1-sided alpha of 0.1 was used. A p-value \<0.1 represents non-inferiority.|Farrington-Manning test|Non-inferiority of tapentadol prolonged-release versus morphine prolonged-release has been demonstrated.|A confidence interval for the risk difference (RD) completely above the pre-specified non-inferiority margin of -0.2 represents non-inferiority of tapentadol prolonged-release versus morphine prolonged-release.|||0.06|-0.19|0.0790
71909063|NCT01306032|143339300|SUPERIORITY_OR_OTHER|||||||0.034|||||||Log Rank|||||||0.034
71909064|NCT01306032|143339300|SUPERIORITY_OR_OTHER|||||||0.68|||||||Log Rank|||||||0.68
71909065|NCT00168064|143339310|NON_INFERIORITY_OR_EQUIVALENCE|The PG formulation was determined to be non-inferior to the AP formulation if the lower limit of the 95% confidence interval around the ratio of the response rates (PG/AP) was \> = 0.75.|ratio of proportions|1.226|||||TWO_SIDED|95.0|0.974|1.552|||ANCOVA||ratio is response rate of PG formulation divided by response rate of AP formulation|||1.552|0.974|
71909066|NCT01376245|143339320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|||<|0.001|TWO_SIDED|95.0|0.089|0.191|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.191|0.089|<0.001
71909067|NCT01376245|143339320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.179|||<|0.001|TWO_SIDED|95.0|0.129|0.23|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.230|0.129|<0.001
71909068|NCT01376245|143339320|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.194|||<|0.001|TWO_SIDED|95.0|0.143|0.245|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)||||0.245|0.143|<0.001
71909069|NCT01357889|143339354|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.937|||||TWO_SIDED|90.0|0.842|1.042|||ANOVA|||||1.042|0.842|
71909070|NCT01357889|143339355|NON_INFERIORITY_OR_EQUIVALENCE|To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.927|||||TWO_SIDED|90.0|0.813|1.056|||ANOVA|||||1.056|0.813|
71909071|NCT03970824|143339356|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|105.79|||||TWO_SIDED|90.0|97.19|115.16||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||115.16|97.19|
71909072|NCT03970824|143339356|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|92.63|||||TWO_SIDED|90.0|85.29|100.61||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||100.61|85.29|
71909073|NCT03970824|143339356|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.0|||||TWO_SIDED|90.0|90.06|106.63||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.63|90.06|
71909074|NCT03970824|143339357|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|107.3|||||TWO_SIDED|90.0|98.29|117.13||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||117.13|98.29|
71909075|NCT03970824|143339357|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|93.93|||||TWO_SIDED|90.0|86.08|102.5||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||102.50|86.08|
71909076|NCT03970824|143339357|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.79|||||TWO_SIDED|90.0|92.42|109.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||109.92|92.42|
71909077|NCT03970824|143339358|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|101.89|||||TWO_SIDED|90.0|95.33|108.89||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||108.89|95.33|
71909078|NCT03970824|143339358|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|98.2|||||TWO_SIDED|90.0|91.91|104.92||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||104.92|91.91|
71909079|NCT03970824|143339358|EQUIVALENCE|PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.|Ratio of geometric least squares means|100.05|||||TWO_SIDED|90.0|93.69|106.85||||||Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.||106.85|93.69|
71909080|NCT00305604|143339370|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.81|<|0.001||95.0|-0.94|-0.47|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-0.47|-0.94|<0.001
71909081|NCT00305604|143339371|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|STANDARD_DEVIATION|45.0|<|0.001||95.0|-40.0|-13.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-13.5|-40.0|<0.001
71909082|NCT00305604|143339372|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-61.0|STANDARD_DEVIATION|63.0|<|0.001||95.0|-82.1|-40.0|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-40.0|-82.1|<0.001
71909083|NCT00305604|143339373|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.5|STANDARD_DEVIATION|25.2|<|0.001||95.0|-32.6|-14.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\< 75/\>= 75 yr); baseline creatinine clearance (\< 50/\>= 50 mL/min)||||-14.4|-32.6|<0.001
71909084|NCT01248364|143339374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.279|TWO_SIDED|95.0|-0.16|0.55|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.55|-0.16|0.2790
71909085|NCT01248364|143339375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.2||0.2438|TWO_SIDED|95.0|-0.16|0.62|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.62|-0.16|0.2438
71909086|NCT01248364|143339376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.75||0.6931|TWO_SIDED|95.0|-1.19|1.79|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||1.79|-1.19|0.6931
71909087|NCT01248364|143339377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.84|STANDARD_ERROR_OF_MEAN|1.12||0.1028|TWO_SIDED|95.0|-0.38|4.07|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||4.07|-0.38|0.1028
71909088|NCT01248364|143339378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|2.52||0.0326|TWO_SIDED|95.0|0.47|10.5|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||10.50|0.47|0.0326
71922098|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|2.82|STANDARD_ERROR_OF_MEAN|3.82|||TWO_SIDED|95.0|-5.1|10.75|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.75|-5.10|
71909089|NCT01248364|143339379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58|STANDARD_ERROR_OF_MEAN|0.81||0.0552|TWO_SIDED|95.0|-3.2|0.04|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||0.04|-3.20|0.0552
71909090|NCT01248364|143339380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.99||0.7561|TWO_SIDED|95.0|-1.66|2.27|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||2.27|-1.66|0.7561
71909091|NCT01248364|143339381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.13|STANDARD_ERROR_OF_MEAN|1.89||0.1024|TWO_SIDED|95.0|-0.64|6.9|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||6.90|-0.64|0.1024
71909092|NCT01248364|143339382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|STANDARD_ERROR_OF_MEAN|2.93||0.6576|TWO_SIDED|95.0|-4.53|7.14|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||7.14|-4.53|0.6576
71909093|NCT01248364|143339383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.68|STANDARD_ERROR_OF_MEAN|3.38||0.2795|TWO_SIDED|95.0|-10.41|3.05|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.||3.05|-10.41|0.2795
71909094|NCT02431468|143339412|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0||||LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.|t-test, 1 sided|||The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)||||<0.1
71909095|NCT02431468|143339412|SUPERIORITY||Mean Difference (Net)|6.5|||<|0.1|TWO_SIDED|80.0|||||t-test, 1 sided|||Change from baseline in SIB in the Completer Analysis Set (CAS)||||<0.1
71909096|NCT00039741|143339428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.13||0.26|TWO_SIDED|95.0|-0.41|0.11|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.11|-0.41|0.26
71909097|NCT00039741|143339428|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.56|TWO_SIDED|95.0|-0.2|0.32|||Interval regression|Adjusted for baseline HIV-1 RNA, age (\<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.||||0.32|-0.20|0.56
71909098|NCT00507416|143339457|SUPERIORITY_OR_OTHER|||||||0.458||||||The global difference among arms was based on the Wald test.|Wald test|||||||0.458
71909099|NCT02157506|143339475|SUPERIORITY||||||=|0.0059|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||=0.0059
71909100|NCT02157506|143339475|SUPERIORITY||||||=|0.0001|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0001
71909101|NCT02157506|143339475|SUPERIORITY||||||=|0.0062|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0062
71909102|NCT02157506|143339475|SUPERIORITY||||||=|0.0086|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0086
71909103|NCT02157506|143339476|SUPERIORITY||||||=|0.0076|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0076
71909104|NCT02157506|143339476|SUPERIORITY||||||=|0.0052|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0052
71909105|NCT02157506|143339476|SUPERIORITY||||||=|0.1064|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1064
71909106|NCT02157506|143339476|SUPERIORITY||||||=|0.1151|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1151
71909107|NCT02157506|143339477|SUPERIORITY||||||=|0.4241|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4241
71909108|NCT02157506|143339477|SUPERIORITY||||||=|0.4035|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4035
71909109|NCT02157506|143339477|SUPERIORITY||||||=|0.8308|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8308
71909110|NCT02157506|143339477|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1180
71909111|NCT02157506|143339478|SUPERIORITY||||||=|0.0048|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0048
71909112|NCT02157506|143339478|SUPERIORITY||||||=|0.0022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0022
71909113|NCT02157506|143339478|SUPERIORITY||||||=|0.0045|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0045
71909114|NCT02157506|143339478|SUPERIORITY||||||=|0.0294|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0294
71909115|NCT02157506|143339479|SUPERIORITY||||||=|0.2022|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2022
71909116|NCT02157506|143339479|SUPERIORITY||||||=|0.0658|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0658
71909117|NCT02157506|143339479|SUPERIORITY||||||=|0.0741|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0741
71909118|NCT02157506|143339479|SUPERIORITY||||||=|0.0497|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.0497
71909119|NCT02157506|143339480|SUPERIORITY||||||=|0.1842|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1842
71909120|NCT02157506|143339480|SUPERIORITY||||||=|0.3328|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.3328
71909121|NCT02157506|143339480|SUPERIORITY||||||=|0.1465|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1465
71909122|NCT02157506|143339480|SUPERIORITY||||||=|0.2799|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2799
71909123|NCT02157506|143339481|SUPERIORITY||||||=|0.2499|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2499
71909124|NCT02157506|143339481|SUPERIORITY||||||=|0.8281|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8281
71909125|NCT02157506|143339481|SUPERIORITY||||||=|0.4121|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4121
71909126|NCT02157506|143339481|SUPERIORITY||||||=|0.8592|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.8592
71909127|NCT02157506|143339482|SUPERIORITY||||||=|0.1391|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1391
71909128|NCT02157506|143339482|SUPERIORITY||||||=|0.1724|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1724
71909129|NCT02157506|143339482|SUPERIORITY||||||=|0.1245|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1245
71909130|NCT02157506|143339482|SUPERIORITY||||||=|0.169|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.1690
71909131|NCT02157506|143339483|SUPERIORITY||||||=|0.4936|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.4936
71909132|NCT02157506|143339483|SUPERIORITY||||||=|0.992|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9920
71909133|NCT02157506|143339483|SUPERIORITY||||||=|0.2789|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.2789
71909134|NCT02157506|143339483|SUPERIORITY||||||=|0.91|||||||Mixed Models Analysis|Statistical significance was defined by a P-value \< 0.05. No adjustments were made for multiplicity.||||||= 0.9100
71909135|NCT01021813|143339491|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-1.1|1.4|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any sleep paralysis AEs between the Suvorexant group and Placebo group .||1.4|-1.1|
71909136|NCT01021813|143339492|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.482|TWO_SIDED|95.0|-1.3|1.1|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any complex sleep-related behaviors AEs between the Suvorexant group and Placebo group.||1.1|-1.3|0.482
71909137|NCT01021813|143339493|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.8||||0.508|TWO_SIDED|95.0|-3.9|1.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any falls AEs between the Suvorexant group and Placebo group.||1.5|-3.9|0.508
71909138|NCT01021813|143339494|SUPERIORITY_OR_OTHER||Difference in Percentage of AEs|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any suicidal ideation/behavior AEs considered an ECI between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
71909139|NCT01021813|143339495|SUPERIORITY_OR_OTHER||Difference in Percentage|0.8||||0.159|TWO_SIDED|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any Hypnagogic/hypnopompic hallucinations AEs between the Suvorexant group and Placebo group.||2.0|-0.7|0.159
71909140|NCT01021813|143339496|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4||||0.767|TWO_SIDED|95.0|-3.8|2.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any selected AEs associated with potential abuse between the Suvorexant group and Placebo group.||2.2|-3.8|0.767
71909141|NCT01021813|143339497|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|-0.81||||0.567|TWO_SIDED|95.0|-5.1|3.1|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.1|-5.1|0.567
71909142|NCT01021813|143339497|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|-2.4||||0.185|TWO_SIDED|95.0|-7.3|1.6|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||1.6|-7.3|0.185
71909143|NCT01021813|143339497|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|-0.78||||0.68|TWO_SIDED|95.0|-5.6|3.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||3.9|-5.6|0.680
71909144|NCT01021813|143339497|SUPERIORITY_OR_OTHER||Difference in Percentage: Across Nights|0.0||||1|TWO_SIDED|95.0|-6.4|6.4|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms across Nights 1, 2, and 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.||6.4|-6.4|1.000
71909145|NCT01021813|143339498|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|5.03||||0.365|TWO_SIDED|95.0|-5.8|15.8|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.8|-5.8|0.365
71909146|NCT01021813|143339498|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|8.72||||0.109|TWO_SIDED|95.0|-2.0|19.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||19.2|-2.0|0.109
71909147|NCT01021813|143339498|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|6.02||||0.287|TWO_SIDED|95.0|-5.1|16.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||16.9|-5.1|0.287
71909148|NCT01021813|143339498|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|10.82||||0.057|TWO_SIDED|95.0|-0.3|21.7|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||21.7|-0.3|0.057
71909149|NCT01021813|143339499|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 1|4.46||||0.386|TWO_SIDED|95.0|-5.7|14.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||14.5|-5.7|0.386
71909150|NCT01021813|143339499|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 2|5.31||||0.311|TWO_SIDED|95.0|-5.0|15.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.5|-5.0|0.311
71909151|NCT01021813|143339499|SUPERIORITY_OR_OTHER||Difference in Percentage: Night 3|4.96||||0.351|TWO_SIDED|95.0|-5.5|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-5.5|0.351
71922099|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.23|6.37|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.37|-15.23|
71681780|NCT00793624|142881795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.109|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.109|<0.0001
71909152|NCT01021813|143339499|SUPERIORITY_OR_OTHER||Difference in Percentage:Night 1, 2 or 3|4.58||||0.409|TWO_SIDED|95.0|-6.3|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.||15.3|-6.3|0.409
71909153|NCT01021813|143339500|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|22.7|||<|0.0001|TWO_SIDED|95.0|16.4|29.0||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSTm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||29.0|16.4|<0.0001
71909154|NCT01021813|143339501|SUPERIORITY_OR_OTHER||Difference in LS Means: Month 1|-9.5||||0.0002|TWO_SIDED|95.0|-14.6|-4.5||To account for multiplicity, Hochberg's procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSOm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.||-4.5|-14.6|0.0002
71909155|NCT00764478|143339503|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.41||0.0136|TWO_SIDED|95.0|-6.3|-0.7||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.7|-6.3|0.0136
71909156|NCT00764478|143339503|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.0|STANDARD_ERROR_OF_MEAN|1.43||0.01|TWO_SIDED|95.0|-6.9|-1.2||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-1.2|-6.9|0.0100
71909157|NCT00764478|143339504|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.01|TWO_SIDED|95.0|-0.8|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-0.2|-0.8|0.0100
71909158|NCT00764478|143339504|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0052|TWO_SIDED|95.0|-0.9|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID|||-0.2|-0.9|0.0052
71909159|NCT00764478|143339505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5352||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.5352
71909160|NCT00764478|143339505|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4274||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel|||||||0.4274
71909161|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-2.7|STANDARD_ERROR_OF_MEAN|0.78||0.0007|TWO_SIDED|95.0|-4.2|-1.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-1.1|-4.2|0.0007
71909162|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|0.79||0.0003|TWO_SIDED|95.0|-4.4|-1.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-1.3|-4.4|0.0003
71909163|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-1.8|-5.4|<0.0001
71909164|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.7|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-5.5|-1.9|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-1.9|-5.5|<0.0001
71909165|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.5|STANDARD_ERROR_OF_MEAN|1.12||0.0021|TWO_SIDED|95.0|-5.7|-1.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-1.3|-5.7|0.0021
71909166|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.2|STANDARD_ERROR_OF_MEAN|1.13||0.0002|TWO_SIDED|95.0|-6.4|-2.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-2.0|-6.4|0.0002
71909167|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.35||0.1907|TWO_SIDED|95.0|-4.4|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-4.4|0.1907
71909168|NCT00764478|143339506|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.1|STANDARD_ERROR_OF_MEAN|1.37||0.0238|TWO_SIDED|95.0|-5.8|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.4|-5.8|0.0238
71909169|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2922|||||||Cochran-Mantel-Haenszel|||Day 2||||0.2922
71909170|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1001|||||||Cochran-Mantel-Haenszel|||Day 2||||0.1001
71909171|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
71909172|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0011
71909173|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0194|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0194
71909174|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0841|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0841
71909175|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4858|||||||Cochran-Mantel-Haenszel|||Day 14||||0.4858
71909176|NCT00764478|143339507|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2496|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2496
71909177|NCT00764478|143339508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2912|||||||Cochran-Mantel-Haenszel|||||||0.2912
71909178|NCT00764478|143339508|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1151|||||||Cochran-Mantel-Haenszel|||||||0.1151
71909179|NCT00764478|143339510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|||Day 7||||0.0019
71909180|NCT00764478|143339510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0045|||||||ANCOVA|||Day 7||||0.0045
71909181|NCT00764478|143339510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0112|||||||ANCOVA|||Day 21||||0.0112
71909182|NCT00764478|143339510|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||ANCOVA|||Day 21||||0.0021
71909183|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.4|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2||-0.1|-0.4|<0.0001
71909184|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.3|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2||-0.1|-0.3|0.0076
71909185|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||-0.2|-0.6|0.0004
71909186|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.004|TWO_SIDED|95.0|-0.5|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4||-0.1|-0.5|0.0040
71909187|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0061|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0061
71909188|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0031|TWO_SIDED|95.0|-0.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.1|-0.6|0.0031
71909189|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1086|TWO_SIDED|95.0|-0.5|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-0.5|0.1086
71909190|NCT00764478|143339511|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.0376|TWO_SIDED|95.0|-0.6|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.0|-0.6|0.0376
71909191|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||ANCOVA|||Day 2||||0.0005
71909192|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||ANCOVA|||Day 2||||0.0026
71909193|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|||||||ANCOVA|||Day 4||||0.0007
71909194|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002|||||||ANCOVA|||Day 4||||0.0002
71909195|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0387|||||||ANCOVA|||Day 7||||0.0387
71909196|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0059|||||||ANCOVA|||Day 7||||0.0059
71909197|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|||||||ANCOVA|||Day 14||||0.3110
71909198|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0613|||||||ANCOVA|||Day 14||||0.0613
71909199|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064|||||||ANCOVA|||Day 21||||0.0640
71909200|NCT00764478|143339512|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139|||||||ANCOVA|||Day 21||||0.0139
71909201|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9708|||||||ANCOVA|||Day 2||||0.9708
71909202|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7891|||||||ANCOVA|||Day 2||||0.7891
71909203|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5222|||||||ANCOVA|||Day 4||||0.5222
71909204|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8686|||||||ANCOVA|||Day 4||||0.8686
71909205|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0696|||||||ANCOVA|||Day 7||||0.0696
71909206|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||ANCOVA|||Day 7||||0.0049
71863170|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.89|1.23|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA1:LA2)||1.23|0.89|
71909207|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||ANCOVA|||Day 14||||0.0196
71909208|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0032|||||||ANCOVA|||Day 14||||0.0032
71909209|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0061|||||||ANCOVA|||Day 21||||0.0061
71909210|NCT00764478|143339513|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012|||||||ANCOVA|||Day 21||||0.0012
71909211|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0147
71909212|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0720
71909213|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1213|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1213
71909214|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0588|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0588
71681781|NCT00793624|142881795|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.139|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.226|0.139|<0.0001
71863171|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.99|||||TWO_SIDED|95.0|0.81|1.21|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA1:LA2)||1.21|0.81|
71909215|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0200
71909216|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0017
71909217|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2401|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2401
71909218|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0009
71909219|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0525|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0525
71909220|NCT00764478|143339514|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0025
71909221|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0377|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0377
71909222|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0771|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0771
71909223|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1264|||||||Cochran-Mantel-Haenszel|||Day 4||||0.1264
71909224|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0280
71909225|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0583|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0583
71909226|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0021|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0021
71909227|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0866
71909228|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0048|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0048
71909229|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0147
71909230|NCT00764478|143339515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0030
71909231|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0104|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0104
71909232|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Day 2||||0.0005
71909233|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0692
71909234|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0128|||||||Cochran-Mantel-Haenszel|||Day 4||||0.0128
71909235|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0809|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0809
71909236|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|||||||Cochran-Mantel-Haenszel|||Day 7||||0.0260
71909237|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2576|||||||Cochran-Mantel-Haenszel|||Day 14||||0.2576
71909238|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077|||||||Cochran-Mantel-Haenszel|||Day 14||||0.0077
71909239|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.396|||||||Cochran-Mantel-Haenszel|||Day 21||||0.3960
71909240|NCT00764478|143339516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0141|||||||Cochran-Mantel-Haenszel|||Day 21||||0.0141
71909241|NCT00764478|143339517|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0056|TWO_SIDED|95.0|-5.1|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.9|-5.1|0.0056
71909242|NCT00764478|143339517|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.9|STANDARD_ERROR_OF_MEAN|1.08||0.0068|TWO_SIDED|95.0|-5.0|-0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.8|-5.0|0.0068
71909243|NCT00764478|143339517|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.33||0.0743|TWO_SIDED|95.0|-5.0|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-5.0|0.0743
71909244|NCT00764478|143339517|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.35||0.0177|TWO_SIDED|95.0|-5.9|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-5.9|0.0177
71863172|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.68|1.17|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)||1.17|0.68|
71863173|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.97|||||TWO_SIDED|95.0|0.73|1.28|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)||1.28|0.73|
71863174|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.95||||||95.0|0.69|1.31|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)||1.31|0.69|
71909245|NCT00764478|143339517|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.8|STANDARD_ERROR_OF_MEAN|1.41||0.0081|TWO_SIDED|95.0|-6.6|-1.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-1.0|-6.6|0.0081
71909246|NCT00764478|143339517|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.2|STANDARD_ERROR_OF_MEAN|1.43||0.0247|TWO_SIDED|95.0|-6.1|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.4|-6.1|0.0247
71863175|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)||1.4|0.88|
71909247|NCT00764478|143339518|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9808|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-0.6|0.9808
71909248|NCT00764478|143339518|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.283|TWO_SIDED|95.0|-0.9|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-0.9|0.2830
71909249|NCT00764478|143339518|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9751|TWO_SIDED|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.6|-0.6|0.9751
71909250|NCT00764478|143339518|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.33||0.7879|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.7879
71681782|NCT00793624|142881796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.122|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.208|0.122|<0.0001
71863176|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.27|||||TWO_SIDED|95.0|0.98|1.65|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA1:LA2)||1.65|0.98|
71909251|NCT00764478|143339518|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.9654|TWO_SIDED|95.0|-0.8|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-0.8|0.9654
71909252|NCT00764478|143339518|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.39||0.3917|TWO_SIDED|95.0|-0.4|1.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.1|-0.4|0.3917
71909253|NCT00764478|143339519|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.41||0.012|TWO_SIDED|95.0|-1.8|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.8|0.0120
71909254|NCT00764478|143339519|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.42||0.0011|TWO_SIDED|95.0|-2.2|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.5|-2.2|0.0011
71863177|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.92|||||TWO_SIDED|95.0|0.78|1.09|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)||1.09|0.78|
71863178|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.97|||||TWO_SIDED|95.0|0.74|1.27|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)||1.27|0.74|
71863179|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.71|1.04|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)||1.04|0.71|
71863180|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.72|1.14|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)||1.14|0.72|
71863181|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.74|1.08|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)||1.08|0.74|
71863182|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)||1.1|0.74|
71863183|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.6|0.99|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)||0.99|0.6|
71863184|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.69|0.99|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)||0.99|0.69|
71863185|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.95|||||TWO_SIDED|95.0|0.83|1.09|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3:LA4)||1.09|0.83|
71863186|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.93||||||95.0|0.78|1.1|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.78|
71863187|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.75|1.03|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3:LA4)||1.03|0.75|
71863188|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.66|0.97|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3:LA4||0.97|0.66|
71909255|NCT00764478|143339519|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6885|TWO_SIDED|95.0|-1.2|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.8|-1.2|0.6885
71909256|NCT00764478|143339519|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.52||0.0398|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-2.1|0.0398
71863189|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.78|||||TWO_SIDED|95.0|0.6|1.02|||ANOVA|||Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)||1.02|0.6|
71863190|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.83|||||TWO_SIDED|95.0|0.63|1.09|||ANOVA|||Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)||1.09|0.63|
71863191|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.81|||||TWO_SIDED|95.0|0.59|1.11|||ANOVA|||Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)||1.11|0.59|
71863192|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.76|1.19|||ANOVA|||Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)||1.19|0.76|
71863193|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|1.07|||||TWO_SIDED|95.0|0.83|1.37|||ANOVA|||HIb (Post-vaccination GMC; group ratio LA3:LA4)||1.37|0.83|
71863194|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.68|0.95|||ANOVA|||PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)||0.95|0.68|
71863195|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.87|||||TWO_SIDED|95.0|0.67|1.14|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)||1.14|0.67|
71909257|NCT00764478|143339519|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.51||0.0258|TWO_SIDED|95.0|-2.1|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.1|-2.1|0.0258
71909258|NCT00764478|143339519|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.5|STANDARD_ERROR_OF_MEAN|0.51||0.0031|TWO_SIDED|95.0|-2.5|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.5|-2.5|0.0031
71863196|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.83|||||TWO_SIDED|95.0|0.69|1.0|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)||1|0.69|
71863197|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.84||||||95.0|0.67|1.05|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)||1.05|0.67|
71909259|NCT00764478|143339520|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.64||0.0033|TWO_SIDED|95.0|-3.2|-0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.6|-3.2|0.0033
71909260|NCT00764478|143339520|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.65||0.0622|TWO_SIDED|95.0|-2.5|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-2.5|0.0622
71909261|NCT00764478|143339520|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|0.79||0.0083|TWO_SIDED|95.0|-3.6|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-3.6|0.0083
71909262|NCT00764478|143339520|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0064|TWO_SIDED|95.0|-3.8|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.6|-3.8|0.0064
71909263|NCT00764478|143339520|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|0.84||0.0022|TWO_SIDED|95.0|-4.3|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.9|-4.3|0.0022
71909264|NCT00764478|143339520|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.85||0.0196|TWO_SIDED|95.0|-3.7|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-3.7|0.0196
71909265|NCT00764478|143339521|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.1883|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.1883
71909266|NCT00764478|143339521|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.4||0.1684|TWO_SIDED|95.0|-1.3|0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.2|-1.3|0.1684
71863198|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.62|0.9|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)||0.9|0.62|
71863199|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.75|1.1|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)||1.1|0.75|
71863200|NCT00474526|143241135|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||TWO_SIDED|95.0|0.69|1.12|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)||1.12|0.69|
71863201|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.2|4.4|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))||4.4|-2.2|
71863202|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.9|2.6|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA1 - PLA2))||2.6|-1.9|
71863203|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-7.7|7.1|||ANOVA|||PT (Seroconversion percentage difference (PLA1 - PLA2))||7.1|-7.7|
71863204|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.2|5.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA1 - PLA2))||5.8|-9.2|
71863205|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-6.0||||||95.0|-12.9|2.2|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA1 - PLA2))||2.2|-12.9|
71863206|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|1.0|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))||1.0|-4.8|
71863207|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.6|2.3|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))||2.3|-4.6|
71863208|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.2|5.1|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))||5.1|-3.2|
71863209|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-1.5|3.5|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))||3.5|-1.5|
71863210|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|5.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||5|-1.1|
71863211|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0||||||95.0|-2.8|7.7|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))||7.7|-2.8|
71863212|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.0|3.3|||ANOVA|||PnC 4(Seroconversion percentage difference (PLA1 - PLA2))||3.3|-3|
71909267|NCT00764478|143339521|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.46||0.9522|TWO_SIDED|95.0|-0.9|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.9|0.9522
71909268|NCT00764478|143339521|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0514|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.0|-1.8|0.0514
71909269|NCT00764478|143339521|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.47||0.0531|TWO_SIDED|95.0|-1.8|0.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.0|-1.8|0.0531
71909270|NCT00764478|143339521|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.3|STANDARD_ERROR_OF_MEAN|0.48||0.0078|TWO_SIDED|95.0|-2.2|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-2.2|0.0078
71909271|NCT00764478|143339522|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.32||0.7746|TWO_SIDED|95.0|-0.7|0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.5|-0.7|0.7746
71909272|NCT00764478|143339522|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2754|TWO_SIDED|95.0|-1.0|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.3|-1.0|0.2754
71909273|NCT00764478|143339522|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.34||0.9109|TWO_SIDED|95.0|-0.6|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.7|-0.6|0.9109
71909274|NCT00764478|143339522|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7295|TWO_SIDED|95.0|-0.6|0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.8|-0.6|0.7295
71909275|NCT00764478|143339522|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.38||0.98|TWO_SIDED|95.0|-0.7|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.8|-0.7|0.9800
71909276|NCT00764478|143339522|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.38||0.5122|TWO_SIDED|95.0|-0.5|1.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||1.0|-0.5|0.5122
71909277|NCT00764478|143339523|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2191|TWO_SIDED|95.0|-0.9|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.9|0.2191
71909278|NCT00764478|143339523|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0589|TWO_SIDED|95.0|-1.1|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.0|-1.1|0.0589
71909279|NCT00764478|143339523|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.36||0.3683|TWO_SIDED|95.0|-1.0|0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.0|0.3683
71909280|NCT00764478|143339523|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.37||0.0982|TWO_SIDED|95.0|-1.3|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||0.1|-1.3|0.0982
71909281|NCT00764478|143339523|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.38||0.1969|TWO_SIDED|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.3|-1.3|0.1969
71681783|NCT00793624|142881796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.116|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.203|0.116|<0.0001
71909282|NCT00764478|143339523|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5615|TWO_SIDED|95.0|-1.0|0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||0.5|-1.0|0.5615
71909283|NCT00764478|143339524|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.33||0.0101|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0101
71909284|NCT00764478|143339524|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.34||0.0146|TWO_SIDED|95.0|-1.5|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||-0.2|-1.5|0.0146
71909285|NCT00764478|143339524|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0861|TWO_SIDED|95.0|-1.4|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.1|-1.4|0.0861
71909286|NCT00764478|143339524|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.39||0.0342|TWO_SIDED|95.0|-1.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.1|-1.6|0.0342
71909287|NCT00764478|143339524|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0037|TWO_SIDED|95.0|-2.0|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.4|-2.0|0.0037
71909288|NCT00764478|143339524|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0096|TWO_SIDED|95.0|-1.9|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.3|-1.9|0.0096
71909289|NCT00764478|143339525|SUPERIORITY_OR_OTHER_LEGACY||Least Square (LS) means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.32||0.0019|TWO_SIDED|95.0|-1.7|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||-0.4|-1.7|0.0019
71909290|NCT00764478|143339525|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.33||0.0791|TWO_SIDED|95.0|-1.2|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7||0.1|-1.2|0.0791
71909291|NCT00764478|143339525|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.36||0.0006|TWO_SIDED|95.0|-2.0|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||-0.5|-2.0|0.0006
71909292|NCT00764478|143339525|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.37||0.0123|TWO_SIDED|95.0|-1.6|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14||-0.2|-1.6|0.0123
71909293|NCT00764478|143339525|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.41||0.0054|TWO_SIDED|95.0|-2.0|-0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||-0.3|-2.0|0.0054
71909294|NCT00764478|143339525|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.41||0.035|TWO_SIDED|95.0|-1.7|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21||-0.1|-1.7|0.0350
71909295|NCT00676793|143339594|SUPERIORITY_OR_OTHER||||||=|0.078||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.078
71909296|NCT00676793|143339595|SUPERIORITY_OR_OTHER||||||=|0.094||95.0|||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.||||=0.094
71909297|NCT02259127|143339608|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.004|TWO_SIDED|95.0|-0.14|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Primary: Diff in adj. KM estimates (\>=14kg)~Number of subjects included in analysis: 707~Analysis specification: Pre-specified"||-0.03|-0.14|= 0.004
71909298|NCT02259127|143339608|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18|||=|0.057|TWO_SIDED|95.0|-0.36|0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Diff in adj. KM estimates (Frequentist \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.02|-0.36|=0.057
71681784|NCT00793624|142881796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.13|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.218|0.130|<0.0001
71863213|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|4.0|||||TWO_SIDED|95.0|-2.2|12.3|||ANOVA|||PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))||12.3|-2.2|
71863214|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.9|3.6|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))||3.6|-3.9|
71863215|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-1.1|6.2|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))||6.2|-1.1|
71863216|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
71863217|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-4.8|2.9|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))||2.9|-4.8|
71863218|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 - PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-4.0|||||TWO_SIDED|95.0|-8.0|1.9|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))||1.9|-8|
71863219|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|3.8|||ANOVA|||Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))||3.8|-2.3|
71863220|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0||||||95.0|-1.3|2.7|||ANOVA|||Tetanus (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-1.3|
71863221|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.8|10.7|||Seroconversion Percentage difference|||PT (Seroconversion percentage difference (PLA3 - PLA4))||10.7|-4.8|
71863222|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-7.1|8.8|||ANOVA|||FHA(Seroconversion percentage difference (PLA3 - PLA4))||8.8|-7.1|
71863223|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-8.0|5.7|||ANOVA|||Pertactin (Seroconversion percentage difference (PLA3 - PLA4))||5.7|-8|
71863224|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.0|4.7|||ANOVA|||Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))||4.7|-2|
71863225|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-3.0|4.8|||ANOVA|||Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))||4.8|-3|
71863226|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.4|4.5|||ANOVA|||Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))||4.5|-4.4|
71863227|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||TWO_SIDED|95.0|-2.3|2.7|||ANOVA|||Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))||2.7|-2.3|
71863228|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||TWO_SIDED|95.0|-5.3|1.0|||ANOVA|||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||1|-5.3|
71922100|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-4.85|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-15.65|5.94|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.94|-15.65|
71909299|NCT02259127|143339608|NON_INFERIORITY|Bayesian estimation was used for the primary analysis of the difference in treatment failure by 96 weeks by arm in \<14kg cohort. An informative prior distribution was used based on the treatment effect observed in \>=14kg cohort, with relative weight defined by clinical opinion, solicited prior to the main trial results.|Risk Difference (RD)|-0.1||||0.02|TWO_SIDED|95.0|-0.19|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Primary: diff in adj. KM estimates (Bayesian \<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-0.02|-0.19|0.02
71909300|NCT02259127|143339608|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12||||0.003|TWO_SIDED|95.0|-0.21|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A\>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.04|-0.21|0.003
71909301|NCT02259127|143339608|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05||||0.22|TWO_SIDED|95.0|-0.12|0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (primary endpoint) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.03|-0.12|0.22
71681785|NCT00793624|142881797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.104|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.191|0.104|<0.0001
71863229|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0||||||95.0|-6.6|3.0|||ANOVA|||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))||3|-6.6|
71863230|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-4.2|3.0|||ANOVA|||PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))||3|-4.2|
71863231|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-4.0|9.0|||ANOVA|||PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))||9|-4|
71863232|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||TWO_SIDED|95.0|-2.8|6.0|||ANOVA|||PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))||6|-2.8|
71863233|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||TWO_SIDED|95.0|-3.7|3.4|||ANOVA|||PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))||3.4|-3.7|
71863234|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-3.0|||||TWO_SIDED|95.0|-7.2|0.8|||ANOVA|||PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))||0.8|-7.2|
71863235|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||TWO_SIDED|95.0|-0.8|7.5|||ANOVA|||PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))||7.5|-0.8|
71863236|NCT00474526|143241136|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 - PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0||||||95.0|-3.7|7.0|||ANOVA|||PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))||7|-3.7|
71863237|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.9|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
71863238|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.62|1.02|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)||1.02|0.62|
71863239|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.67|1.2|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)||1.2|0.67|
71863240|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||TWO_SIDED|95.0|0.63|1.03|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)||1.03|0.63|
71863241|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.02|||||TWO_SIDED|95.0|0.78|1.34|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.78|
71681786|NCT00793624|142881797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.112|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.200|0.112|<0.0001
71681787|NCT00793624|142881797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.123|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.211|0.123|<0.0001
71681788|NCT00793624|142881798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.183|0.095|<0.0001
71681789|NCT00793624|142881798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.095|0.184|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.184|0.095|<0.0001
71681790|NCT00793624|142881798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.117|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.206|0.117|<0.0001
71909302|NCT02259127|143339609|SUPERIORITY||Risk Difference (RD)|5.0|||=|0.1377|TWO_SIDED|95.0|-1.0|11.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 665~Analysis Specification: Pre-specified"||11|-1|= 0.1377
71909303|NCT02259127|143339609|SUPERIORITY||Risk Difference (RD)|-1.0|||=|0.8895|TWO_SIDED|95.0|-10.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||8|-10|= 0.8895
71909304|NCT02259127|143339609|SUPERIORITY||Risk Difference (RD)|9.0|||=|0.0435|TWO_SIDED|95.0|0.4|17.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 381~Analysis Specification: Pre-specified"||17|0.4|=0.0435
71909305|NCT02259127|143339609|SUPERIORITY||Risk Difference (RD)|26.0||||0.021|TWO_SIDED|95.0|6.0|47.0|||Regression, Logistic|||||47|6|0.021
71909306|NCT02259127|143339610|SUPERIORITY||Risk Difference (RD)|3.0|||=|0.2256|TWO_SIDED|95.0|-2.0|8.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 670~Analysis Specification: Pre-specified"||8|-2|= 0.2256
71909307|NCT02259127|143339610|SUPERIORITY||Risk Difference (RD)|0.0|||=|0.9536|TWO_SIDED|95.0|-8.0|7.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 286~Analysis Specification: Pre-specified"||7|-8|= 0.9536
71909308|NCT02259127|143339610|SUPERIORITY||Risk Difference (RD)|6.0|||=|0.1104|TWO_SIDED|95.0|-1.0|12.0|||Regression, Logistic|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 384~Analysis Specification: Pre-specified"||12|-1|= 0.1104
71909309|NCT02259127|143339610|SUPERIORITY||Risk Difference (RD)|19.0||||0.038|TWO_SIDED|95.0|2.0|37.0|||Regression, Logistic|||||37|2|0.038
71909310|NCT02259127|143339611|SUPERIORITY||Mean Difference (Final Values)|35.0|||=|0.144|TWO_SIDED|95.0|-12.0|82.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusted for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||82|-12|= 0.144
71909311|NCT02259127|143339611|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.185|TWO_SIDED|95.0|-21.0|109.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||109|-21|0.185
71909312|NCT02259127|143339611|SUPERIORITY||Mean Difference (Final Values)|27.0|||=|0.427|TWO_SIDED|95.0|-39.0|93.0|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of CD4 at week 96, adjusting for randomised arm, baseline CD4 and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||93|-39|= 0.427
71909313|NCT02259127|143339611|SUPERIORITY||Median Difference (Final Values)|30.0||||0.86|TWO_SIDED|95.0|-308.0|368.0|||Regression, Linear|||||368|-308|0.86
71909314|NCT02259127|143339612|SUPERIORITY||Mean Difference (Final Values)|-15.1|||<|0.001|TWO_SIDED|95.0|-19.0|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-11.1|-19|< 0.001
71909315|NCT02259127|143339612|SUPERIORITY||Mean Difference (Final Values)|-24.4|||=|0.0032|TWO_SIDED|95.0|-40.3|-8.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\<14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||-8.5|-40.3|= 0.0032
71909316|NCT02259127|143339612|SUPERIORITY||Mean Difference (Final Values)|-17.5|||<|0.001|TWO_SIDED|95.0|-23.9|-11.1|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-11.1|-23.9|< 0.001
71909317|NCT02259127|143339612|SUPERIORITY||Mean Difference (Final Values)|-13.4|||<|0.001|TWO_SIDED|95.0|-18.5|-8.4|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of total cholesterol at week 96, adjusting for randomised arm, baseline total cholesterol and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-8.4|-18.5|< 0.001
71909318|NCT02259127|143339613|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.53|TWO_SIDED|95.0|0.55|1.36|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.36|0.55|= 0.53
71909319|NCT02259127|143339613|SUPERIORITY||Hazard Ratio (HR)|1.08|||=|0.86|TWO_SIDED|95.0|0.47|2.49|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2.49|0.47|= 0.86
71863242|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.04||||||95.0|0.81|1.34|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)||1.34|0.81|
71863243|NCT00474526|143241151|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.69|1.29|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)||1.29|0.69|
71863244|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|1.0|||||TWO_SIDED|95.0|-8.0|10.0|||ANOVA|||PnC 4 (percentage difference (US1A - US1B))||10|-8|
71863245|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|0.0|10.0|||ANOVA|||PnC 6B (percentage difference (US1A - US1B))||10|0|
71863246|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-4.0|||||TWO_SIDED|95.0|-13.0|5.0|||ANOVA|||PnC 9V (percentage difference (US1A - US1B))||5|-13|
71863247|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0|||ANOVA|||PnC 14 (percentage difference (US1A - US1B))||3|-6|
71863248|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-6.0|||||TWO_SIDED|95.0|-15.0|3.0|||ANOVA|||PnC 18C (percentage difference (US1A:US1B))||3|-15|
71863249|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||TWO_SIDED|95.0|-4.0|11.0|||ANOVA|||PnC 19F (percentage difference (US1A:US1B))||11|-4|
71863250|NCT00474526|143241152|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A - PUS1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||PnC 239F (percentage difference (US1A:US1B))||5|-10|
71863251|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.61|1.02|||ANOVA|||PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)||1.02|0.61|
71863252|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.81|||||TWO_SIDED|95.0|0.54|1.2|||ANOVA|||PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)||1.2|0.54|
71863253|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.58|0.94|||ANOVA|||PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)||0.94|0.58|
71863254|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.65|||||TWO_SIDED|95.0|0.51|0.82|||ANOVA|||PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)||0.82|0.51|
71863255|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.6|1.01|||ANOVA|||PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.6|
71863256|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.56|1.04|||ANOVA|||PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.04|0.56|
71863257|NCT00474526|143241153|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||TWO_SIDED|95.0|0.54|1.01|||ANOVA|||PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)||1.01|0.54|
71863258|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-9.6|5.2|||ANOVA|||PnC 4 (percentage difference (LA1A - LA1B))||5.2|-9.6|
71863259|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||TWO_SIDED|95.0|-11.9|7.3|||ANOVA|||PnC 6B (percentage difference (LA1A - LA1B))||7.3|-11.9|
71863260|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-10.9|4.3|||ANOVA|||PnC 9V (percentage difference (LA1A - LA1B))||4.3|-10.9|
71863261|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-1.0|||||TWO_SIDED|95.0|-5.6|2.7|||ANOVA|||PnC 14 (percentage difference (LA1A - LA1B))||2.7|-5.6|
71863262|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-14.0|||||TWO_SIDED|95.0|-24.1|-5.6|||ANOVA|||PnC 18C (percentage difference (LA1A - LA1B))||-5.6|-24.1|
71681791|NCT00793624|142881799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.149|0.297|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.297|0.149|<0.0001
71681792|NCT00793624|142881799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.309|0.161|<0.0001
71681793|NCT00793624|142881799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.307|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.233|0.381|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.381|0.233|<0.0001
71681794|NCT00793624|142881800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.161|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.161|<0.0001
71681795|NCT00793624|142881800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.249|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.175|0.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.324|0.175|<0.0001
71681796|NCT00793624|142881800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.235|0.384|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.384|0.235|<0.0001
71681797|NCT00793624|142881801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.135|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.285|0.135|<0.0001
71681798|NCT00793624|142881801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.254|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.179|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.329|0.179|<0.0001
71863263|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||TWO_SIDED|95.0|-11.6|5.2|||ANOVA|||PnC 19F (percentage difference (LA1A - LA1B))||5.2|-11.6|
71863264|NCT00474526|143241154|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A - PLA1B) had to be greater than -10%.|Percentage difference|0.0|||||TWO_SIDED|95.0|-7.0|7.0|||ANOVA|||PnC 23F (percentage difference (LA1A - LA1B))||7|-7|
71863265|NCT00474526|143241155|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.05|||||TWO_SIDED|95.0|0.86|1.27|||ANOVA|||Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)||1.27|0.86|
71863266|NCT00474526|143241155|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.94|||||TWO_SIDED|95.0|0.75|1.18|||ANOVA|||Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)||1.18|0.75|
71909320|NCT02259127|143339613|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.52|TWO_SIDED|95.0|0.48|1.46|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.46|0.48|= 0.52
71863267|NCT00474526|143241155|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.11|||||TWO_SIDED|95.0|0.88|1.4|||ANOVA|||PT (Post-vaccination GMC; group ratio LA3A:LA3B)||1.4|0.88|
71863268|NCT00474526|143241155|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.9|1.44|||ANOVA|||FHA (Post-vaccination GMC; group ratio LA3A:LA3B)||1.44|0.9|
71863269|NCT00474526|143241155|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.21|||||TWO_SIDED|95.0|0.92|1.59|||ANOVA|||Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B||1.59|0.92|
71863270|NCT00474526|143241155|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.63|1.16|||ANOVA|||Hib (Post-vaccination GMC; group ratio LA3A:LA3B)||1.16|0.63|
71863271|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0||||||95.0|-4.2|5.4|||ANOVA|||Diphtheria (percentage difference (LA3A - LA3B))||5.4|-4.2|
71863272|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-4.2|5.4|||ANOVA|||Tetanus (percentage difference (LA3A - LA3B))||5.4|-4.2|
71863273|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|6.0||||||95.0|-3.6|15.2|||ANOVA|||PT (percentage difference (LA3A - LA3B))||15.2|-3.6|
71863274|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|-1.0|||||TWO_SIDED|95.0|-10.2|8.2|||ANOVA|||FHA (percentage difference (LA3A - LA3B))||8.2|-10.2|
71863275|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|2.0|||||TWO_SIDED|95.0|-7.2|10.6|||ANOVA|||Pertactin (percentage difference (LA3A - LA3B))||10.6|-7.2|
71863276|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||TWO_SIDED|95.0|-3.1|3.6|||ANOVA|||Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))||3.6|-3.1|
71909321|NCT02259127|143339613|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.86|TWO_SIDED|95.0|0.42|2.04|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||2.04|0.42|= 0.86
71909322|NCT02259127|143339614|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.24|TWO_SIDED|95.0|0.61|1.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.13|0.61|= 0.24
71909323|NCT02259127|143339614|SUPERIORITY||Hazard Ratio (HR)|0.93|||=|0.83|TWO_SIDED|95.0|0.5|1.74|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||1.74|0.5|= 0.83
71863277|NCT00474526|143241156|NON_INFERIORITY_OR_EQUIVALENCE|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|1.0|||||TWO_SIDED|95.0|-2.2|5.3|||ANOVA|||Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))||5.3|-2.2|
71863278|NCT01251770|143241165|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||Serum Sodium difference at the beginning||||0.030
71863279|NCT01251770|143241165|SUPERIORITY_OR_OTHER|||||||0.871||95.0|||||t-test, 2 sided|||Serum Sodium at the end of the study||||0.871
71863280|NCT01251770|143241166|SUPERIORITY_OR_OTHER|||||||0.895|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.895
71863281|NCT01020877|143241182|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test\[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.0|||||TWO_SIDED|90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
71863282|NCT01020877|143241183|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|98.2|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|98.2|
71863283|NCT01020877|143241184|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||TWO_SIDED|90.0|97.6|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||115|97.6|
71863284|NCT04307940|143241185|SUPERIORITY||LS Mean Difference|14.81||||0.001|TWO_SIDED|95.0|6.1|23.51||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||23.51|6.10|0.001
71863285|NCT04307940|143241185|SUPERIORITY||LS Mean Difference|39.63|||<|0.001|TWO_SIDED|95.0|29.08|50.18||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||50.18|29.08|<0.001
71863286|NCT04307940|143241185|SUPERIORITY||LS Mean Difference|24.82|||<|0.001|TWO_SIDED|95.0|14.26|35.39||All p-values were presented using two-sided test with alpha 0.05 and were considered statistically significant.|ANCOVA|||||35.39|14.26|<0.001
71863287|NCT04624243|143241194|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-2.8||||0.241|TWO_SIDED|97.5|-8.3|2.6|||ANCOVA|||||2.6|-8.3|0.241
71863288|NCT04624243|143241194|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS change from baseline|LS Mean Difference|-0.7||||0.784|TWO_SIDED|97.5|-6.3|4.9|||ANCOVA|||||4.9|-6.3|0.784
71863289|NCT04624243|143241196|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.3||||0.096|TWO_SIDED|97.5|-3.1|0.5|||ANCOVA|||||0.5|-3.1|0.096
71863290|NCT04624243|143241196|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 PANSS PSS change from baseline|LS Mean Difference|-1.4||||0.094|TWO_SIDED|97.5|-3.2|0.5|||ANCOVA|||||0.5|-3.2|0.094
71909324|NCT02259127|143339614|SUPERIORITY||Hazard Ratio (HR)|1.13|||=|0.57|TWO_SIDED|95.0|0.75|1.7|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.7|0.75|= 0.57
71909325|NCT02259127|143339614|SUPERIORITY||Hazard Ratio (HR)|0.54|||=|0.01|TWO_SIDED|95.0|0.33|0.88|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.88|0.33|= 0.01
71909326|NCT02259127|143339615|SUPERIORITY||Hazard Ratio (HR)|0.29|||=|0.01|TWO_SIDED|95.0|0.11|0.77|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.77|0.11|= 0.01
71863291|NCT04624243|143241197|SUPERIORITY|It was hypothesized that MK-8189 16 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|-0.2||||0.254|TWO_SIDED|97.5|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.254
71863292|NCT04624243|143241197|SUPERIORITY|It was hypothesized that MK-8189 24 mg is superior to placebo in reducing Week 6 CGI-S change from baseline|LS Mean Difference|0.0||||0.959|TWO_SIDED|97.5|-0.3|0.3|||ANCOVA|||||0.3|-0.3|0.959
71863293|NCT04624243|143241201|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-8.5|||<|0.001|TWO_SIDED|97.5|-10.4|-6.5|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-6.5|-10.4|<0.001
71909327|NCT02259127|143339615|SUPERIORITY||Hazard Ratio (HR)|0.35|||=|0.13|TWO_SIDED|95.0|0.09|1.33|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||1.33|0.09|= 0.13
71863294|NCT04624243|143241201|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-7.3|||<|0.001|TWO_SIDED|97.5|-9.3|-5.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-5.2|-9.3|<0.001
71863295|NCT04624243|143241202|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-6.0|||<|0.001|TWO_SIDED|97.5|-7.4|-4.6|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.6|-7.4|<0.001
71863296|NCT04624243|143241202|SUPERIORITY|Estimated Treatment Difference vs Risperidone|LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.0|-4.2|||ANCOVA|Covariates were treatment, stratum (US Black, US-Non-Black, Other), gender (male, female), and with baseline value, the duration of illness and age||||-4.2|-7.0|<0.001
71909328|NCT02259127|143339615|SUPERIORITY||Hazard Ratio (HR)|0.22||||0.055|TWO_SIDED|95.0|0.05|1.03|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.03|0.05|0.055
71909329|NCT02259127|143339616|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.06|||=|0.003|TWO_SIDED|95.0|-0.1|-0.02|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.02|-0.1|= 0.003
71909330|NCT02259127|143339616|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.035|TWO_SIDED|95.0|-0.13|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.01|-0.13|= 0.035
71909331|NCT02259127|143339616|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.05|||=|0.039|TWO_SIDED|95.0|-0.11|-0.004|||Bootstrap method||The probability of having virological or clinical treatment failure by 48 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 48 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||-0.004|-0.11|= 0.039
71909332|NCT02259127|143339616|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.18||||0.057|TWO_SIDED|95.0|-0.36|0.02|||Other [Bootstrap method]|||||0.02|-0.36|0.057
71909333|NCT02259127|143339617|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.09|||=|0.003|TWO_SIDED|95.0|-0.16|-0.04|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||-0.04|-0.16|= 0.003
71909334|NCT02259127|143339617|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.12|||=|0.009|TWO_SIDED|95.0|-0.21|-0.03|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||-0.03|-0.21|= 0.009
71909335|NCT02259127|143339617|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.08|||=|0.079|TWO_SIDED|95.0|-0.16|0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 144 weeks was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 144 weeks after randomisation.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.01|-0.16|= 0.079
71909336|NCT02259127|143339618|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.993|TWO_SIDED|95.0|0.38|2.68|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||2.68|0.38|= 0.993
71909337|NCT02259127|143339618|SUPERIORITY||Hazard Ratio (HR)|0.5|||=|0.33|TWO_SIDED|95.0|0.13|2.0|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (\<14kg)~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||2|0.13|= 0.33
71909338|NCT02259127|143339618|SUPERIORITY||Hazard Ratio (HR)|1.01|||=|0.991|TWO_SIDED|95.0|0.32|3.12|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY A \>=14kg)~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||3.12|0.32|= 0.991
71909339|NCT02259127|143339618|SUPERIORITY||Hazard Ratio (HR)|1.0|||=|0.997|TWO_SIDED|95.0|0.14|7.13|||Regression, Cox|||"Statistical Analysis Title: Adjusted time to first event (ODYSSEY B \>=14kg)~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||7.13|0.14|= 0.997
71909340|NCT02259127|143339619|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.07|||=|0.015|TWO_SIDED|95.0|-0.12|-0.01|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Diff in adj. KM estimates (\>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 677~Analysis Specification: Pre-specified"||-0.01|-0.12|= 0.015
71863297|NCT04896008|143241224|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.13|0.43||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||HR and associated 95% confidence interval were based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.43|0.13|<0.0001
71863298|NCT04896008|143241225|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0313|TWO_SIDED|95.0|0.17|1.07||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||1.07|0.17|0.0313
71863299|NCT04896008|143241226|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0039|TWO_SIDED|95.0|0.15|0.78||One-sided p-value based on log-rank test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||0.78|0.15|0.0039
71863300|NCT04896008|143241227|SUPERIORITY||Treatment Difference|-7.29||||0.135|TWO_SIDED|95.0|-17.65|2.41||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype)|||2.41|-17.65|0.135
71863301|NCT04896008|143241228|SUPERIORITY||Treatment Difference|-3.1|||<|0.001|TWO_SIDED|95.0|-4.25|-1.88||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by a randomization stratification factor (PAH subtype).|||-1.88|-4.25|<0.001
71863302|NCT04896008|143241229|SUPERIORITY||Treatment Difference|33.05|||<|0.001|TWO_SIDED|95.0|18.41|46.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by a randomization stratification factor (PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by a randomization stratification factors (PAH subtype).|||46.98|18.41|<0.001
71863303|NCT04896008|143241230|SUPERIORITY||Treatment Difference|-2339.1|||<|0.001|TWO_SIDED|95.0|-3378.74|-1299.44||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-1299.44|-3378.74|<0.001
71863304|NCT04896008|143241231|SUPERIORITY||Treatment Difference|-21.2|||<|0.001|TWO_SIDED|95.0|-27.78|-14.59||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-14.59|-27.78|<0.001
71863305|NCT04896008|143241232|SUPERIORITY||Treatment Difference|-339.6|||<|0.001|TWO_SIDED|95.0|-511.09|-168.06||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||-168.06|-511.09|<0.001
71863306|NCT04896008|143241233|SUPERIORITY||Treatment Difference|27.41|||<|0.001|TWO_SIDED|95.0|12.85|40.98||Two-sided p-value is calculated based on Cochran-Mantel-Haenszel method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|Cochran-Mantel-Haenszel||Based on Miettinen and Nurminen method stratified by the randomization stratification factors (REVEAL Lite 2.0 risk score and PAH subtype).|||40.98|12.85|<0.001
71863307|NCT04896008|143241234|SUPERIORITY||Treatment Difference|63.0|||<|0.001|TWO_SIDED|95.0|23.22|102.73||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||102.73|23.22|<0.001
71863308|NCT04896008|143241235|SUPERIORITY||Treatment Difference|0.5||||0.119|TWO_SIDED|95.0|-0.18|1.16||Two-sided p-value is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype)|Aligned Rank Stratified Wilcoxon||Hodges-Lehmann location shift estimate with 95% CI is provided using aligned rank stratified Wilcoxon test stratified by randomization stratification factor (REVEAL Lite 2.0 risk score and PAH subtype).|||1.16|-0.18|0.119
71922101|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-0.81|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED|95.0|-9.1|7.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||7.47|-9.10|
71863309|NCT01270828|143241246|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
71863310|NCT01270828|143241247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.||||<0.0001
71863311|NCT01270828|143241248|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
71863312|NCT01270828|143241249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.||||<0.0001
71922102|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-2.63|STANDARD_ERROR_OF_MEAN|3.76|||TWO_SIDED|95.0|-10.42|5.16|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.16|-10.42|
71909341|NCT02259127|143339619|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.172|||=|0.075|TWO_SIDED|95.0|-0.362|0.029|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for trial cohort (ODYSSEY A or ODYSSEY B)|"Statistical Analysis Title: Adjusted difference (frequentist \<14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 85~Analysis Specification: Pre-specified"||0.029|-0.362|= 0.075
71909342|NCT02259127|143339619|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.126|||=|0.004|TWO_SIDED|95.0|-0.21|-0.036|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 295~Analysis Specification: Pre-specified"||-0.036|-0.21|= 0.004
71909343|NCT02259127|143339619|NON_INFERIORITY|"\>=14kg cohort: Non-inferiority margin 10% in total population and 12% in ODYSSEY A/ODYSSEY B.~\<14kg cohort: power for efficacy was not prespecified for this cohort."|Risk Difference (RD)|-0.023|||=|0.547|TWO_SIDED|95.0|-0.096|0.056|||Bootstrap method||The probability of having virological or clinical treatment failure by 96 weeks (per protocol analysis) was estimated using Kaplan-Meier curves adjusted for stratification factors.|"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Difference in adjusted (for stratification factors) Kaplan-Meier survival function estimates at 96 weeks after randomisation.~Number of subjects included in analysis: 382~Analysis Specification: Pre-specified"||0.056|-0.096|= 0.547
71909344|NCT02259127|143339634|SUPERIORITY||Mean Difference (Final Values)|1.0|||=|0.004|TWO_SIDED|95.0|0.3|1.7|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||1.7|0.3|= 0.004
71909345|NCT02259127|143339634|SUPERIORITY||Mean Difference (Final Values)|1.4|||=|0.024|TWO_SIDED|95.0|0.2|2.5|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||2.5|0.2|= 0.024
71909346|NCT02259127|143339634|SUPERIORITY||Mean Difference (Final Values)|0.8|||=|0.075|TWO_SIDED|95.0|-0.1|1.6|||Regression, Linear|||"Statistical Analysis Title: Adjusting Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of weight at week 96, adjusting for randomised arm, baseline weight and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||1.6|-0.1|= 0.075
71909347|NCT02259127|143339634|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.67|TWO_SIDED|95.0|-0.8|0.5|||Regression, Linear|||||0.5|-0.8|0.67
71909348|NCT02259127|143339635|SUPERIORITY||Mean Difference (Final Values)|0.13|||=|0.036|TWO_SIDED|95.0|0.01|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (\>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 707~Analysis Specification: Pre-specified"||0.25|0.01|= 0.036
71909349|NCT02259127|143339635|SUPERIORITY||Mean Difference (Final Values)|0.17|||=|0.092|TWO_SIDED|95.0|-0.03|0.36|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY A \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 311~Analysis Specification: Pre-specified"||0.36|-0.03|=0.092
71909350|NCT02259127|143339635|SUPERIORITY||Mean Difference (Final Values)|0.1|||=|0.176|TWO_SIDED|95.0|-0.05|0.25|||Regression, Linear|||"Statistical Analysis Title: Adjusted Difference (ODYSSEY B \>=14kg)~Statistical analysis description: Linear regression of BMI-for-age at week 96, adjusting for randomised arm, baseline BMI-for-age and stratification factors. Presenting mean difference between arms.~Number of subjects included in analysis: 396~Analysis Specification: Pre-specified"||0.25|-0.05|=0.176
71909351|NCT02259127|143339635|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5|TWO_SIDED|95.0|-1.1|0.5|||Regression, Linear|||||0.5|-1.1|0.50
71909352|NCT02455388|143339638|EQUIVALENCE|No equivalence margin set.|||||<|0.001|||||||Intraclass correlation coefficient|||||||<0.001
71909353|NCT02455388|143339639|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71909354|NCT02455388|143339640|OTHER||Odds Ratio (OR)|1.7|||<|0.01|TWO_SIDED||||||Regression, Logistic|||||||<0.01
71909355|NCT01316939|143339642|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.9|4.8||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.8|-12.9|
71909356|NCT01316939|143339642|SUPERIORITY_OR_OTHER||Percent difference of participants|-6.6|||||TWO_SIDED|95.0|-14.8|1.6||||||Placebo Vs GSK1605786A 500 mg BID at Week 28 and 52||1.6|-14.8|
71909357|NCT01316939|143339643|SUPERIORITY_OR_OTHER||Percent difference of participants|-4.0|||||TWO_SIDED|95.0|-12.2|4.2||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52||4.2|-12.2|
71909358|NCT01316939|143339643|SUPERIORITY_OR_OTHER||Percent difference of participants|-5.3|||||TWO_SIDED|95.0|-13.1|2.6||||||||2.6|-13.1|
71909359|NCT01016678|143339673|SUPERIORITY_OR_OTHER||Difference in percentages|18.0||||0.0038|TWO_SIDED||||||Chi-squared|||Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)||||0.0038
71909360|NCT01016678|143339674|SUPERIORITY_OR_OTHER||difference in percentages|8.0||||0.1294|TWO_SIDED||||||Chi-squared|||||||0.1294
71681799|NCT00793624|142881801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.276|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.201|0.352|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.352|0.201|<0.0001
71681800|NCT00793624|142881802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.107|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.258|0.107|<0.0001
71681801|NCT00793624|142881802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.139|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.291|0.139|<0.0001
71863313|NCT01270828|143241250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.26|-0.62|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.62|-1.26|<0.0001
71863314|NCT01270828|143241250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.21|-0.61|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.61|-1.21|<0.0001
71863315|NCT01270828|143241251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.47|-0.75|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.75|-1.47|<0.0001
71909361|NCT00093470|143339712|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.76||||0.026|TWO_SIDED|95.0|0.538|1.072||one-sided p-value; threshold for statistical significance \<0.025|Log Rank|stratified log rank test|Hazard ratio of DFS for Arm A to Arm B|||1.072|0.538|0.026
71909362|NCT00093470|143339713|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.809||||0.056|TWO_SIDED|95.0|0.567|1.155||one-sided p-value; threshold for statistical significance \< 0.025|Log Rank|stratified log rank test|Hazard ratio of OS for Arm A to Arm B|||1.155|0.567|0.056
71909363|NCT00877006|143339724|SUPERIORITY_OR_OTHER|||||||0.0005||||||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.|ANCOVA|||The hypothesis of interest is superiority of BR over standard treatment.||||0.0005
71909364|NCT00877006|143339725|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9677|TWO_SIDED|95.0|0.58|1.68|||Log Rank|Stratified log-rank test by preassigned standard treatment and lymphoma type.|BR/RCHOP-RCVP|||1.68|0.58|0.9677
71909365|NCT02034552|143339742|SUPERIORITY|||||||0.0109||||||\[80% CI\]: \[10.1%- 39.6%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||0.0109
71909366|NCT02034552|143339742|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[40.8% - 73.7%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
71909367|NCT02034552|143339742|SUPERIORITY||||||<|0.0001||||||\[80% CI\]: \[31.8% - 68.2%\]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.||||<0.0001
71909368|NCT01779648|143339776|SUPERIORITY_OR_OTHER|||||||0.785||95.0|||||Chi-squared|||||||0.785
71909369|NCT01779648|143339777|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.195
71681802|NCT00793624|142881802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.318|0.166|<0.0001
71863316|NCT01270828|143241251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.65|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.65|-1.34|<0.0001
71863317|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0324|TWO_SIDED|95.0|-6.1|-0.3|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-6.1|0.0324
71863318|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0223|TWO_SIDED|95.0|-6.1|-0.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.5|-6.1|0.0223
71909370|NCT01779648|143339778|SUPERIORITY_OR_OTHER|||||||0.722||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.722
71909371|NCT01779648|143339779|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.158
71909372|NCT01779648|143339780|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.||||0.301
71909373|NCT01779648|143339781|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline TVF (total volume flow) are controlled as fixed-effects parameters.||||||<0.001
71909374|NCT01779648|143339782|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PVF (peak volume flow) are controlled as fixed-effects parameters.||||||<0.001
71909375|NCT01779648|143339783|SUPERIORITY_OR_OTHER|||||||0.929||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline PV (peak velocity)are controlled as fixed-effects parameters.||||||0.929
71909376|NCT01779648|143339785|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline peak volume flow are controlled as fixed-effects parameters.||||||0.008
71909377|NCT01779648|143339786|SUPERIORITY_OR_OTHER|||||||0.132||95.0|||||Mixed Models Analysis|Age, sex, body mass index, and baseline total volume flow are controlled as fixed-effects parameters.||||||0.132
71681803|NCT00793624|142881803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.103|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.256|0.103|<0.0001
71909378|NCT03004976|143339836|OTHER||Wilcoxon Mann-Whitney Odds|0.9|STANDARD_ERROR_OF_MEAN|0.248||0.71|TWO_SIDED|95.0|0.53|1.55||Wilcoxon Two Sample Test|Wilcoxon (Mann-Whitney)|||Primary efficacy analysis (mRS shift from baseline to 90 days)||1.55|0.53|0.71
71909379|NCT03004976|143339836|OTHER||Odds Ratio (OR)|0.9|STANDARD_ERROR_OF_MEAN|0.223||0.87|TWO_SIDED|95.0|0.4|2.3|||Cumulative Logit Proportional Odds Model|||Additional analysis of the primary endpoint (mRS score at 90 days), adjusted for baseline mRS, baseline NIHSS, and institution.||2.3|0.4|0.87
71909380|NCT03807245|143339862|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 25mcg/placebo||||<0.0001
71909381|NCT03807245|143339862|OTHER||||||<|0.0001|||||||ANOVA|||Adjusted geometric mean fold increase from Day 1 to Day 85: adjusted geometric mean ratio GBS-NN/NN2 50mcg/placebo||||<0.0001
71909382|NCT00291499|143339865|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.016
71909383|NCT00291499|143339866|SUPERIORITY||Mean Difference (Final Values)|-2.14||||0.008|TWO_SIDED||||||t-test, 2 sided|||||||0.008
71909384|NCT00291499|143339867|SUPERIORITY|||||||0.043||||||Threshold p \<0.05|Cochran-Mantel-Haenszel|||||||0.043
71909385|NCT00291499|143339868|SUPERIORITY|||||||0.132||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.132
71909386|NCT00291499|143339869|SUPERIORITY|||||||0.031||||||Threshold p\<0.05|Wilcoxon (Mann-Whitney)|||||||0.031
71909387|NCT00291499|143339870|SUPERIORITY||Mean Difference (Final Values)|0.363|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71909388|NCT01807949|143339894|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.62||||0.0004|TWO_SIDED|95.0|1.18|4.06|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than \[\<\] 18 versus greater than equal to \[\>=\]18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.06|1.18|0.0004
71909389|NCT01807949|143339894|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0|||<|0.0001|TWO_SIDED|95.0|1.56|4.44|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.44|1.56|<0.0001
71909390|NCT01807949|143339895|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42||||0.0007|TWO_SIDED|95.0|1.86|6.98|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||6.98|1.86|0.0007
71909391|NCT01807949|143339895|SUPERIORITY_OR_OTHER||LS Mean Difference|5.25|||<|0.0001|TWO_SIDED|95.0|2.69|7.81|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||7.81|2.69|<0.0001
71909392|NCT01807949|143339896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41|||<|0.0001|TWO_SIDED|95.0|0.23|0.59|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.59|0.23|<0.0001
71909393|NCT01807949|143339896|SUPERIORITY_OR_OTHER||LS Mean Difference|0.36||||0.0001|TWO_SIDED|95.0|0.17|0.54|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.54|0.17|0.0001
71909394|NCT01807949|143339897|SUPERIORITY_OR_OTHER||LS Mean Difference|2.21||||0.1651|TWO_SIDED|95.0|-0.91|5.33|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||5.33|-0.91|0.1651
71909395|NCT01807949|143339897|SUPERIORITY_OR_OTHER||LS Mean Difference|2.85||||0.0736|TWO_SIDED|95.0|-0.27|5.98|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||5.98|-0.27|0.0736
71909396|NCT01807949|143339898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9568|||<|0.0001|TWO_SIDED|95.0|1.8829|4.6431||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.6431|1.8829|<0.0001
71909397|NCT01807949|143339898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3834||||0.0001|TWO_SIDED|95.0|1.5234|3.7286||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.7286|1.5234|0.0001
71909398|NCT01807949|143339899|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6912||||0.0116|TWO_SIDED|95.0|0.5187|0.9209||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9209|0.5187|0.0116
71909399|NCT01807949|143339899|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.5659||||0.0002|TWO_SIDED|95.0|0.4191|0.7641||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.7641|0.4191|0.0002
71909400|NCT01807949|143339900|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13|||<|0.0001|TWO_SIDED|95.0|0.62|1.64|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||1.64|0.62|<0.0001
71909401|NCT01807949|143339900|SUPERIORITY_OR_OTHER||LS Mean Difference|0.95||||0.0003|TWO_SIDED|95.0|0.43|1.46|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||1.46|0.43|0.0003
71909402|NCT01807949|143339901|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2313||||0.0005|TWO_SIDED|95.0|0.1037|0.3589|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.3589|0.1037|0.0005
71909403|NCT01807949|143339901|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2217||||0.0006|TWO_SIDED|95.0|0.0961|0.3473|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.3473|0.0961|0.0006
71909404|NCT01807949|143339902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0384|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0384
71909405|NCT01807949|143339902|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.533||||0.0003|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0003
71909406|NCT01807949|143339903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6373||||0.0393|TWO_SIDED|95.0|0.416|0.9764|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||0.9764|0.4160|0.0393
71909407|NCT01807949|143339903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4429||||0.0002|TWO_SIDED|95.0|0.2863|0.6851|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||0.6851|0.2863|0.0002
71909408|NCT01807949|143339904|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0028||||0.7679|TWO_SIDED|95.0|-0.0211|0.0156|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0156|-0.0211|0.7679
71909409|NCT01807949|143339904|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0009||||0.9214|TWO_SIDED|95.0|-0.0192|0.0174|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0174|-0.0192|0.9214
71909410|NCT01807949|143339905|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4||||0.1034|TWO_SIDED|95.0|-0.5|5.3|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||5.3|-0.5|0.1034
71909411|NCT01807949|143339905|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.0262|TWO_SIDED|95.0|0.4|6.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||6.2|0.4|0.0262
71909412|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|8.64||||0.0005|TWO_SIDED|95.0|3.77|13.51|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||13.51|3.77|0.0005
71909413|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|11.61|||<|0.0001|TWO_SIDED|95.0|6.75|16.48|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||16.48|6.75|<0.0001
71909414|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.0403|TWO_SIDED|95.0|-6.21|-0.14|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-0.14|-6.21|0.0403
71909415|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.29||||0.0054|TWO_SIDED|95.0|-7.31|-1.28|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.28|-7.31|0.0054
71922103|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-5.54|STANDARD_ERROR_OF_MEAN|3.98|||TWO_SIDED|95.0|-13.8|2.72|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.72|-13.80|
71922104|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-0.01|STANDARD_ERROR_OF_MEAN|3.97|||TWO_SIDED|95.0|-8.25|8.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||8.23|-8.25|
71863319|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.0098|TWO_SIDED|95.0|-6.6|-0.9|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-0.9|-6.6|0.0098
71863320|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0033|TWO_SIDED|95.0|-6.7|-1.4|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-1.4|-6.7|0.0033
71863321|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3||||0.0002|TWO_SIDED|95.0|-11.1|-3.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.5|-11.1|0.0002
71863322|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|||<|0.0001|TWO_SIDED|95.0|-12.2|-5.2|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-5.2|-12.2|<0.0001
71863323|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4||||0.5264|TWO_SIDED|95.0|-2.8|5.6|||ANCOVA|||This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.6|-2.8|0.5264
71863324|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.452|TWO_SIDED|95.0|-5.2|2.3|||ANCOVA|||This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.3|-5.2|0.4520
71863325|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.3714|TWO_SIDED|95.0|-4.7|1.8|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||1.8|-4.7|0.3714
71909416|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||1|TWO_SIDED|95.0|-4.07|4.07|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.07|-4.07|1.0000
71863326|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.5639|TWO_SIDED|95.0|-4.2|2.3|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||2.3|-4.2|0.5639
71863327|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.3223|TWO_SIDED|95.0|-2.4|7.3|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.3|-2.4|0.3223
71863328|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.7||||0.2742|TWO_SIDED|95.0|-2.2|7.6|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.6|-2.2|0.2742
71863329|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9816|TWO_SIDED|95.0|-3.2|3.1|||ANCOVA|||This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.1|-3.2|0.9816
71863330|NCT01270828|143241252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9282|TWO_SIDED|95.0|-2.9|3.2|||ANCOVA|||This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.2|-2.9|0.9282
71863331|NCT01270828|143241253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.1635|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.4|-0.1|0.1635
71863332|NCT01270828|143241253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.0363||95.0|0.0|0.5|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||0.5|0.0|0.0363
71863333|NCT01270828|143241254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.432|||||||Chi-squared|||This analysis is for Week 6||||0.432
71863334|NCT01270828|143241254|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987|||||||Chi-squared|||This analysis is for Week 19||||0.987
71863335|NCT01270828|143241255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85||||0.0007|TWO_SIDED|95.0|1.3|2.65|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.||2.65|1.30|0.0007
71863336|NCT01270828|143241255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.32||||0.0009|TWO_SIDED|95.0|1.41|3.81|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio \> 1 is in favor of Pregabalin DB."|This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.||3.81|1.41|0.0009
71909417|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|0.32||||0.8777|TWO_SIDED|95.0|-3.74|4.37|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||4.37|-3.74|0.8777
71909418|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|4.64||||0.0668|TWO_SIDED|95.0|-0.32|9.61|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||9.61|-0.32|0.0668
71863337|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4||||0.0003|TWO_SIDED|95.0|3.4|11.5|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.5|3.4|0.0003
71863338|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.7|||<|0.0001|TWO_SIDED|95.0|4.0|11.3|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||11.3|4.0|<0.0001
71863339|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.0275|TWO_SIDED|95.0|0.4|6.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||6.0|0.4|0.0275
71863340|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4|||<|0.0001|TWO_SIDED|95.0|2.8|8.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||8.0|2.8|<0.0001
71909419|NCT01807949|143339906|SUPERIORITY_OR_OTHER||LS Mean Difference|7.16||||0.0045|TWO_SIDED|95.0|2.23|12.08|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||12.08|2.23|0.0045
71909420|NCT05014542|143339913|SUPERIORITY||Mean Difference (Final Values)|-42.8|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 15) - mean (WOMAC total of group C in Week 15)|WOMAC total analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
71909421|NCT05014542|143339914|SUPERIORITY||Mean Difference (Final Values)|-8.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 15) - mean (WOMAC pain of group C at Week 15)|WOMAC pain analysis between groups at Week 15. The Shapiro-Wilk test (S-W) was used for testing the normality of the data distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at assessments.||||<.001
71909422|NCT05014542|143339915|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A at Week 15) - mean (WOMAC stiffness of group C at Week 15)|WOMAC stiffness between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
71909423|NCT05014542|143339916|SUPERIORITY||Mean Difference (Final Values)|-30.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 15) - mean (WOMAC functional disability of group C in Week 15)|WOMAC functional disability between groups at Week 15. The Shapiro-Wilk test (S-W) tests normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with a power of 95 % and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment (the mid-spread).||||<0.001
71909424|NCT05014542|143339917|SUPERIORITY||Mean Difference (Final Values)|-48.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS of group A in Week 15) - mean (VAS of group C in Week 15)|Visual Analogue Scale (VAS) was compared between groups at Week 15, when the acupuncture of group A ended. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) presented the statistical dispersion of sample data at specified assessments.||||<0.001
71863341|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0735|TWO_SIDED|95.0|-0.3|6.4|||ANCOVA|||This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.3|0.0735
71863342|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.0684|TWO_SIDED|95.0|-0.2|6.2|||ANCOVA|||This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.2|-0.2|0.0684
71681804|NCT00793624|142881803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.126|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.280|0.126|<0.0001
71863343|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1197|TWO_SIDED|95.0|-0.7|6.4|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.4|-0.7|0.1197
71863344|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.1||||0.221|TWO_SIDED|95.0|-1.3|5.5|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.5|-1.3|0.2210
71863345|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.0847|TWO_SIDED|95.0|-0.5|7.1|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.1|-0.5|0.0847
71863346|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0||||0.0365|TWO_SIDED|95.0|0.3|7.8|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||7.8|0.3|0.0365
71863347|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.2749|TWO_SIDED|95.0|-1.2|4.3|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||4.3|-1.2|0.2749
71863348|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.0806|TWO_SIDED|95.0|-0.3|5.2|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||5.2|-0.3|0.0806
71863349|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0||||0.0082|TWO_SIDED|95.0|0.5|3.4|||ANCOVA|||This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.4|0.5|0.0082
71863350|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.0008|TWO_SIDED|95.0|1.0|3.7|||ANCOVA|||This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||3.7|1.0|0.0008
71909425|NCT05014542|143339918|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ of group A in Week 15) - mean (KDSQ of group C in Week 15)|The Kidney Deficiency Syndrome Questionnaire (KDSQ) was compared between groups in Week 15. The Shapiro-Wilk test (S-W) tests the normality of data distribution. The comparability of groups regarding the null hypothesis of similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were used to analyse the statistical dispersion of specified sample data at specified assessment.||||<0.001
71909426|NCT05014542|143339919|SUPERIORITY||Mean Difference (Final Values)|-774.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG of A group in Week 15) - mean (DRUG of C group in Week 15)|In Week 15, DRUG was compared between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||<0.001
71909427|NCT05014542|143339920|SUPERIORITY||Mean Difference (Final Values)|0.009||||0.8493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group L knee in Week 15) - mean (C group L knee in Week 15)|Active extension of left (L) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.8493
71909428|NCT05014542|143339920|SUPERIORITY||Mean Difference (Final Values)|-0.107||||0.69654|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (A group R knee in Week 15) - mean (C group R knee in Week 15)|Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.69654
71909429|NCT05014542|143339921|SUPERIORITY||Mean Difference (Final Values)|3.9||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion L knee of group A at Week 15) - mean (active flexion L knee of group C at Week 15)|L knee flexion between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.490
71922105|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-2.89|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-12.01|6.23|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||6.23|-12.01|
71922106|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|4.32|||TWO_SIDED|95.0|-6.78|11.13|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||11.13|-6.78|
71909430|NCT05014542|143339921|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.517|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (active flexion R knee of group A at Week 15) - mean (active flexion R knee of group C at Week 15)|Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.517
71909431|NCT05014542|143339922|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.083|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A at Week 15) - mean (circumference of L upper leg of group C at Week 15)|Circumference of the left (L) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessment.||||0.083
71909432|NCT05014542|143339922|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.084|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A at Week 15) - mean (circumference of R upper leg of group C at Week 15)|Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments.||||0.084
71909433|NCT05014542|143339923|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.341|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knee of group A at Week 15) - mean (circumference of L knee of group C at Week 15)|Circumference of the left (L) knee in Week 15 was analysed between groups. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.341
71909434|NCT05014542|143339923|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.317|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knee of group A at Week 15) - mean (circumference of R knee of group C at Week 15)|Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments.||||0.317
71909435|NCT05014542|143339924|SUPERIORITY||Mean Difference (Final Values)|-33.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 24) -mean (WOMAC total of group C in Week 24)|WOMAC total was analysed in Week 24 between groups, nine weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tested the normality of the distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
71909436|NCT05014542|143339925|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain of group A at Week 24) - mean (WOMAC pain of group C at Week 24)|WOMAC pain was analysed between groups 9 weeks after acupuncture ended in Week 24. The Shapiro-Wilk test (S-W) tested the normality distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data (the mid-spread).||||<.001
71909437|NCT05014542|143339926|SUPERIORITY||Mean Difference (Final Values)|-2.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness of group A in Week 24) - mean (WOMAC stiffness of group C in Week 24)|WOMAC stiffness between groups A and C in Week 24, 9 weeks after acupuncture ended. The Shapiro-Wilk test (S-W) tests the normality of distribution. Group comparability was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
71909438|NCT05014542|143339927|SUPERIORITY||Mean Difference (Final Values)|-24.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability of group A in Week 24) - mean (WOMAC functional disability of group C in Week 24)|WOMAC functional disability at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests the normality of data. The comparability of groups regarding specified variables (to accept or reject the null hypothesis of comparability) was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of specified sample data at specified assessments.||||<0.001
71909439|NCT05014542|143339928|SUPERIORITY||Mean Difference (Final Values)|-45.7|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 24 of group A) - mean (VAS in Week 24 of group C)|VAS was compared between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
71909440|NCT05014542|143339929|SUPERIORITY||Mean Difference (Final Values)|-11.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 24 of group A) - mean (KDSQ in Week 24 of group C)|KDSQ between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. The comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
71681805|NCT00793624|142881803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.166|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.320|0.166|<0.0001
71909441|NCT05014542|143339930|SUPERIORITY||Mean Difference (Final Values)|-581.5|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 24 of group A) - mean (DRUG in Week 24 of group C)|The DRUG between groups in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data.||||<0.001
71909442|NCT05014542|143339931|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext L of A group in Week 24) - mean (Act ext L of C group in Week 24)|Left (L) knee analysis between groups A and C in Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability was tested with the Mann-Whitney U test, with 95% statistical power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessment.||||
71909443|NCT05014542|143339931|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED||||||||mean (Act ext R knee of A group in Week 24) - mean (Act ext R knee of C group in Week 24)|Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment.||||
71909444|NCT05014542|143339932|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.953|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (L knee act flexion of group A in Week 24) - mean (L knee act flexion of group C in Week 24)|Left (L) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of specified sample data at a specified assessment (time-point).||||0.953
71909445|NCT05014542|143339932|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.491|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (R knee act flexion of group A in Week 24) - mean (R knee act flexion of group C in Week 24)|Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment.||||0.491
71909446|NCT05014542|143339933|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.261|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L upper leg of group A in Week 24) - mean (circumference of L upper leg of group C in Week 24)|Circumference of the left (L) upper leg between groups in Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of a distribution. The comparability of groups regarding specified variables to accept or reject the hypothesis of groups comparability was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.261
71909447|NCT05014542|143339933|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.273|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R upper leg of group A in Week 24) - mean (circumference of R upper leg of group C in Week 24)|Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments.||||0.273
71909448|NCT05014542|143339934|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.445|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of L knees in Week 24 of group A) - mean (circumference of L knees in Week 24 of group C)|Circumference of left (L) knees in Week 24, in between-groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at an assessment.||||0.445
71909449|NCT05014542|143339934|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.26|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (circumference of R knees in Week 24 of group A) - mean (circumference of R knees in Week 24 of group C)|Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments.||||0.260
71681806|NCT00793624|142881804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.039||0.0781||95.0|-0.008|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.143|-0.008|0.0781
71863351|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.2097|TWO_SIDED|95.0|-0.8|2.5|||ANCOVA|||This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.5|-0.8|0.2097
71863352|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.1669|TWO_SIDED|95.0|-0.5|2.8|||ANCOVA|||This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||2.8|-0.5|0.1669
71863353|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.1466|TWO_SIDED|95.0|-1.0|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|-1.0|0.1466
71863354|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4||||0.0439|TWO_SIDED|95.0|0.1|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||6.7|0.1|0.0439
71863355|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.025|TWO_SIDED|95.0|0.6|9.3|||ANCOVA|||This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.3|0.6|0.0250
71863356|NCT01270828|143241256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.0107|TWO_SIDED|95.0|1.3|9.5|||ANCOVA|||This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||9.5|1.3|0.0107
71909450|NCT05014542|143339935|SUPERIORITY||Mean Difference (Final Values)|-34.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total of group A in Week 39) - mean (WOMAC total of group A in Week 0)|Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total of group A in Week 39 (24 weeks after acupunctures ended) was compared with the pre-experimental baseline assessment by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. The null hypothesis at weeks 0 and 39 was tested with the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of the sample.||||<0.001
71909451|NCT05014542|143339935|SUPERIORITY||Mean Difference (Final Values)|-39.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC total in Week 39 of group C) - mean (WOMAC total in Week 0 of group C).|WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample.||||< 0.001
71922107|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|4.68|||TWO_SIDED|95.0|-13.93|5.47|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||5.47|-13.93|
71863357|NCT01270828|143241257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.64|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.64|-1.23|<0.0001
71863358|NCT01270828|143241257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.12|-0.58|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.||-0.58|-1.12|<0.0001
71863359|NCT01270828|143241258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0154|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0154
71863360|NCT01270828|143241258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0027|TWO_SIDED|95.0|-1.3|-0.3|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.3|-1.3|0.0027
71863361|NCT01270828|143241258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0166|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.2|0.0166
71863362|NCT01270828|143241258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0217|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-0.1|-1.1|0.0217
71863363|NCT01270828|143241259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.5|-3.0|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-3.0|-5.5|<0.0001
71863364|NCT01270828|143241259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.7|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.||-2.7|-5.0|<0.0001
71922108|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|1.37|STANDARD_ERROR_OF_MEAN|4.59|||TWO_SIDED|95.0|-8.14|10.88|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||10.88|-8.14|
71909452|NCT05014542|143339936|SUPERIORITY||Mean Difference (Final Values)|-6.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group A) - mean (WOMAC pain in Week 0 of group A)|The pain subscale of the WOMAC index of group A in Week 39 (24 weeks after acupunctures ended) was compared with baseline by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of sample data at assessments.||||<0.001
71909453|NCT05014542|143339936|SUPERIORITY||Mean Difference (Final Values)|-7.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC pain in Week 39 of group C) - mean (WOMAC pain in Week 0 of group C)|The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
71909454|NCT05014542|143339937|SUPERIORITY||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group A) - mean (WOMAC stiffness in Week 0 of group A)|The stiffness subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71909455|NCT05014542|143339937|SUPERIORITY||Mean Difference (Final Values)|-3.0|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC stiffness in Week 39 of group C) - mean (WOMAC stiffness in Week 0 of group C)|The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data.||||<0.001
71909456|NCT05014542|143339938|SUPERIORITY||Mean Difference (Final Values)|-25.3|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group A) - mean(WOMAC functional disability in Week 0 of group A)|The functional disability subscale of the WOMAC index of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71909457|NCT05014542|143339938|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (WOMAC functional disability in Week 39 of group C) - mean (WOMAC functional disability in Week 0 of group C)|The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71909458|NCT05014542|143339939|SUPERIORITY||Mean Difference (Final Values)|-41.2|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group A) - mean (VAS in Week 0 of group A)|VAS of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71909459|NCT05014542|143339939|SUPERIORITY||Mean Difference (Final Values)|-31.1|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (VAS in Week 39 of group C) - mean (VAS in Week 0 of group C)|VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||< 0.001
71909460|NCT05014542|143339940|SUPERIORITY||Mean Difference (Final Values)|-12.6|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group A) - mean (KDSQ in Week 0 of group A)|KDSQ of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71909461|NCT05014542|143339940|SUPERIORITY||Mean Difference (Final Values)|-11.4|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (KDSQ in Week 39 of group C) - mean (KDSQ in Week 0 of group C)|KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||<0.001
71681807|NCT00793624|142881804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.077|STANDARD_ERROR_OF_MEAN|0.039||0.0455||95.0|0.002|0.153|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.153|0.002|0.0455
71681808|NCT00793624|142881804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.039||0.029||95.0|0.009|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.160|0.009|0.0290
71863365|NCT01270828|143241259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.5|-2.7|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.7|-6.5|<0.0001
71681809|NCT00793624|142881805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.039||0.0043||95.0|0.035|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.186|0.035|0.0043
71681810|NCT00793624|142881805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.039||0.0007||95.0|0.055|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.207|0.055|0.0007
71922109|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-0.57|STANDARD_ERROR_OF_MEAN|4.7|||TWO_SIDED|95.0|-10.32|9.18|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||9.18|-10.32|
71922110|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|2.49|STANDARD_ERROR_OF_MEAN|4.6|||TWO_SIDED|95.0|-7.04|12.02|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||12.02|-7.04|
71922111|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-7.89|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-18.33|2.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||2.55|-18.33|
71922112|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.03|||TWO_SIDED|95.0|-16.92|3.95|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||3.95|-16.92|
71922113|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-3.84|STANDARD_ERROR_OF_MEAN|4.91|||TWO_SIDED|95.0|-14.03|6.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.35|-14.03|
71922114|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|0.78|STANDARD_ERROR_OF_MEAN|4.62|||TWO_SIDED|95.0|-8.8|10.35|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||10.35|-8.80|
71922115|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-7.13|STANDARD_ERROR_OF_MEAN|5.12|||TWO_SIDED|95.0|-17.79|3.53|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.53|-17.79|
71922116|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|1.66|STANDARD_ERROR_OF_MEAN|4.93|||TWO_SIDED|95.0|-8.59|11.91|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||11.91|-8.59|
71922117|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-6.31|STANDARD_ERROR_OF_MEAN|4.74|||TWO_SIDED|95.0|-16.17|3.55|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||3.55|-16.17|
71922118|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-1.17|STANDARD_ERROR_OF_MEAN|4.54|||TWO_SIDED|95.0|-10.6|8.27|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||8.27|-10.60|
71922119|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-7.01|STANDARD_ERROR_OF_MEAN|5.83|||TWO_SIDED|95.0|-19.13|5.11|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||5.11|-19.13|
71922120|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-4.11|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-15.55|7.34|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||7.34|-15.55|
71922121|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|1.77|STANDARD_ERROR_OF_MEAN|5.48|||TWO_SIDED|95.0|-9.63|13.17|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||13.17|-9.63|
71922122|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-3.47|STANDARD_ERROR_OF_MEAN|5.18|||TWO_SIDED|95.0|-14.25|7.31|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.31|-14.25|
71922123|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-1.73|STANDARD_ERROR_OF_MEAN|4.57|||TWO_SIDED|95.0|-11.24|7.77|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||7.77|-11.24|
71922124|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|-5.55|STANDARD_ERROR_OF_MEAN|4.46|||TWO_SIDED|95.0|-14.83|3.73|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.73|-14.83|
71909462|NCT05014542|143339941|SUPERIORITY||Mean Difference (Final Values)|-361.4||||0.204|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group A) - mean (DRUG in Week 0 of group A)|The DRUG of group A in Week 39 (24 weeks after acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.204
71909463|NCT05014542|143339941|SUPERIORITY||Mean Difference (Final Values)|-305.4||||0.134|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (DRUG in Week 39 of group C) - mean (DRUG in Week 0 of group C)|The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data.||||0.134
71909464|NCT05014542|143339942|SUPERIORITY||Mean Difference (Final Values)|-7.53|||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||mean (Lequesne index in Week 24 of A group) - mean (Lequesne index in Week 24 of C group)|The Lequesne index in Week 24 compared two confirmed comparable groups (at baseline), 9 weeks after acupuncture treatment in group A ended, while the C group was still a control. The Shapiro-Wilk test (S-W) tests normality distribution. The between-group comparability test at Week 24 was provided to accept or reject the null hypothesis by the Mann-Whitney U test, with 95 % power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion.||||< 0.001
71909465|NCT00318565|143339978|SUPERIORITY_OR_OTHER||Binomial distribution|93.3||||0.05|ONE_SIDED|95.0|90.1||||Exact binomial distribution|||An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.|||90.1|.05
71681811|NCT00793624|142881805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.039||0.0005||95.0|0.06|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.212|0.060|0.0005
71909466|NCT00318565|143339979|SUPERIORITY_OR_OTHER||Binomial Distribution|1.5||||0.05|ONE_SIDED|95.0||7.0|||Exact Binomial Distribution|||The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%||7||.05
71909467|NCT00493974|143340032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Wilcoxon (Mann-Whitney)|||||||.3876
71909468|NCT00493974|143340033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6413||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6413
71909469|NCT00493974|143340034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6433||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6433
71909470|NCT00493974|143340035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||95.0|||||Chi-squared|||||||0.63
71909471|NCT00493974|143340036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957||95.0|||||t-test, 2 sided|||||||0.4957
71681812|NCT00793624|142881806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.097|STANDARD_ERROR_OF_MEAN|0.039||0.0136||95.0|0.02|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.173|0.020|0.0136
71909472|NCT00493974|143340037|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71909473|NCT00493974|143340038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0|||||t-test, 2 sided|||||||0.006
71909474|NCT02555657|143340039|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0574|TWO_SIDED|95.0|0.57|1.06|||Regression, Cox|||||1.06|0.57|0.0574
71909475|NCT02555657|143340040|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0728|TWO_SIDED|95.0|0.69|1.06|||Regression, Cox|||||1.06|0.69|0.0728
71909476|NCT02555657|143340041|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3802|TWO_SIDED|95.0|0.82|1.15|||Regression, Cox|||||1.15|0.82|0.3802
71909477|NCT02555657|143340042|SUPERIORITY||Difference in percentages|8.3||||0.0457|TWO_SIDED|95.0|-1.4|18.4|||Miettinen & Nurminen method|||||18.4|-1.4|0.0457
71909478|NCT02555657|143340043|SUPERIORITY||Difference in percentages|2.9||||0.1752|TWO_SIDED|95.0|-3.3|9.2|||Miettinen & Nurminen method|||||9.2|-3.3|0.1752
71681813|NCT00793624|142881806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.039||0.0076||95.0|0.028|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.028|0.0076
71909479|NCT02555657|143340044|SUPERIORITY||Difference in percentages|-1.0||||0.6629|TWO_SIDED|95.0|-5.9|3.8|||Miettinen & Nurminen method|||||3.8|-5.9|0.6629
71909480|NCT02555657|143340045|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.7936|TWO_SIDED|95.0|0.82|1.59|||Regression, Cox|||||1.59|0.82|0.7936
71909481|NCT02555657|143340046|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.9964|TWO_SIDED|95.0|1.08|1.68|||Regression, Cox|||||1.68|1.08|0.9964
71909482|NCT02555657|143340047|SUPERIORITY||Hazard Ratio (HR)|1.6||||1|TWO_SIDED|95.0|1.33|1.92|||Regression, Cox|||||1.92|1.33|1.0000
71909483|NCT02555657|143340051|SUPERIORITY||Difference in percentages|2.3||||0.3388|TWO_SIDED|95.0|-8.7|13.5|||Miettinen & Nurminen method|||||13.5|-8.7|0.3388
71909484|NCT02555657|143340052|SUPERIORITY||Difference in percentages|-1.6||||0.6701|TWO_SIDED|95.0|-8.6|5.5|||Miettinen & Nurminen method|||||5.5|-8.6|0.6701
71909485|NCT02555657|143340053|SUPERIORITY||Difference in percentages|-6.5||||0.9877|TWO_SIDED|95.0|-12.2|-0.8|||Miettinen & Nurminen method|||||-0.8|-12.2|0.9877
71909486|NCT00599027|143340068|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Endpoint after 28 days of treatment|ANCOVA|Overall treatment effect tested using F-test(alpha=0.05;two-sided). Diff between least square means of the 2 groups calculated with two-sided 95% C.I||||||0.001
71909487|NCT00476996|143340069|SUPERIORITY||Weighted Difference|20.4|||<|0.0001|TWO_SIDED|95.0|12.8|27.9|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.9|12.8|< 0.0001
71909488|NCT00476996|143340069|SUPERIORITY||Weighted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|17.7|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|17.7|< 0.0001
71909489|NCT00476996|143340069|SUPERIORITY||Weighted Difference|29.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||36.6|21.6|< 0.0001
71909490|NCT00476996|143340069|SUPERIORITY||Weighted Difference|30.3|||<|0.0001|TWO_SIDED|95.0|22.8|37.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||37.7|22.8|< 0.0001
71909491|NCT00476996|143340070|SUPERIORITY||Weighted Difference|2.1||||0.1885|TWO_SIDED|95.0|-1.0|5.2|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||5.2|-1.0|0.1885
71909492|NCT00476996|143340070|SUPERIORITY||Weighted Difference|3.6||||0.033|TWO_SIDED|95.0|0.3|6.8|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy||6.8|0.3|0.0330
71681814|NCT00793624|142881806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.039||0.0294||95.0|0.009|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.163|0.009|0.0294
71909493|NCT00476996|143340071|SUPERIORITY||Weighted Difference|4.2||||0.0175|TWO_SIDED|95.0|0.7|7.6|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.6|0.7|0.0175
71909494|NCT00476996|143340071|SUPERIORITY||Weighted Difference|4.3||||0.0134|TWO_SIDED|95.0|0.9|7.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||7.8|0.9|0.0134
71909495|NCT00476996|143340071|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.8|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.8|6.2|< 0.0001
71909496|NCT00476996|143340071|SUPERIORITY||Weighted Difference|10.5|||<|0.0001|TWO_SIDED|95.0|6.2|14.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||14.7|6.2|< 0.0001
71909497|NCT00476996|143340072|SUPERIORITY||Adjusted Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.8|-0.3|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.3|-0.8|< 0.0001
71909498|NCT00476996|143340072|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.6|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.6|-1.1|< 0.0001
71909499|NCT00476996|143340072|SUPERIORITY||Adjusted Mean Difference|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.7|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.7|-1.2|< 0.0001
71909500|NCT00476996|143340072|SUPERIORITY||Adjusted Mean Difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment||-0.9|-1.5|< 0.0001
71909501|NCT00476996|143340073|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.0001|TWO_SIDED|95.0|1.85|3.66|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||3.66|1.85|< 0.0001
71909502|NCT00476996|143340073|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.0001|TWO_SIDED|95.0|2.49|4.91|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy||4.91|2.49|< 0.0001
71909503|NCT00476996|143340073|SUPERIORITY||Odds Ratio (OR)|4.18|||<|0.0001|TWO_SIDED|95.0|2.93|5.96|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||5.96|2.93|< 0.0001
71909504|NCT00476996|143340073|SUPERIORITY||Odds Ratio (OR)|5.04|||<|0.0001|TWO_SIDED|95.0|3.54|7.18|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy||7.18|3.54|< 0.0001
71909505|NCT00476996|143340074|SUPERIORITY||Weighted Difference|13.2|||<|0.0001|TWO_SIDED|95.0|7.4|19.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||19.1|7.4|< 0.0001
71863366|NCT01270828|143241259|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.2|||<|0.0001|TWO_SIDED|95.0|-6.0|-2.4|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."||-2.4|-6.0|<0.0001
71863367|NCT01270828|143241260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.77||||0.0161|TWO_SIDED|95.0|1.34|17.0|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||17.00|1.34|0.0161
71909506|NCT00476996|143340074|SUPERIORITY||Weighted Difference|16.2|||<|0.0001|TWO_SIDED|95.0|10.2|22.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||22.1|10.2|< 0.0001
71909507|NCT00476996|143340074|SUPERIORITY||Weighted Difference|19.3|||<|0.0001|TWO_SIDED|95.0|12.9|25.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||25.6|12.9|< 0.0001
71909508|NCT00476996|143340074|SUPERIORITY||Weighted Difference|20.8|||<|0.0001|TWO_SIDED|95.0|14.5|27.1|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||27.1|14.5|< 0.0001
71909509|NCT00476996|143340075|SUPERIORITY||Weighted Difference|4.6||||0.0203|TWO_SIDED|95.0|0.7|8.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||8.5|0.7|0.0203
71909510|NCT00476996|143340075|SUPERIORITY||Weighted Difference|6.7||||0.0014|TWO_SIDED|95.0|2.6|10.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||10.8|2.6|0.0014
71909511|NCT00476996|143340075|SUPERIORITY||Weighted Difference|6.6||||0.0042|TWO_SIDED|95.0|2.1|11.2|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||11.2|2.1|0.0042
71909512|NCT00476996|143340075|SUPERIORITY||Weighted Difference|13.4|||<|0.0001|TWO_SIDED|95.0|8.2|18.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||18.6|8.2|< 0.0001
71909513|NCT00476996|143340076|SUPERIORITY||Weighted Difference|19.4|||<|0.0001|TWO_SIDED|95.0|11.3|27.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||27.5|11.3|< 0.0001
71909514|NCT00476996|143340076|SUPERIORITY||Weighted Difference|24.7|||<|0.0001|TWO_SIDED|95.0|16.8|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy||32.7|16.8|< 0.0001
71909515|NCT00476996|143340076|SUPERIORITY||Weighted Difference|27.2|||<|0.0001|TWO_SIDED|95.0|19.5|34.9|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||34.9|19.5|< 0.0001
71909516|NCT00476996|143340076|SUPERIORITY||Weighted Difference|27.6|||<|0.0001|TWO_SIDED|95.0|20.0|35.3|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy||35.3|20.0|< 0.0001
71681815|NCT00793624|142881807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.039||0.8674||95.0|-0.071|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|-0.071|0.8674
71863368|NCT01270828|143241260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.48||||0.0378|TWO_SIDED|95.0|1.05|5.85|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||5.85|1.05|0.0378
71909517|NCT01181778|143340087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Daily Pill|-0.4||||0.705|TWO_SIDED|95.0|-2.6|1.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.||1.8|-2.6|0.705
71909518|NCT01181778|143340087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Weekly Patch|3.8|||<|0.0001|TWO_SIDED|95.0|2.6|5.0|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.||5.0|2.6|<0.0001
71909519|NCT01181778|143340087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Monthy Ring|16.0|||<|0.0001|TWO_SIDED|95.0|14.3|17.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.||17.8|14.3|<0.0001
71909520|NCT01181778|143340087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Other Method|-3.6|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.2|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.||-2.2|-5.0|<0.0001
71909521|NCT01181778|143340087|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage: Undecided|-15.8|||<|0.0001|TWO_SIDED|95.0|-17.6|-14.1|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.||-14.1|-17.6|<0.0001
71909522|NCT00223652|143340175|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||=.001
71909523|NCT00223652|143340175|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71909524|NCT00223652|143340175|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED||||||Mixed Models Analysis|||||||0.95
71909525|NCT00223652|143340176|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
71909526|NCT00223652|143340177|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<.0001
71909527|NCT00223652|143340177|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Mixed Models Analysis|||||||0.61
71909528|NCT00223652|143340177|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Mixed Models Analysis|||||||0.20
71909529|NCT00223652|143340178|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Generalized estimating equations models|||||||<0.0001
71909530|NCT00223652|143340178|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Generalized estimating equations models|||||||0.12
71909531|NCT00223652|143340178|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Generalized estimating equations models|||||||0.86
71909532|NCT00223652|143340179|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Mixed Models Analysis|||||||>0.37
71909533|NCT00223652|143340180|SUPERIORITY_OR_OTHER||||||>|0.37|TWO_SIDED||||||Generalized estimating equations models|||||||>0.37
71909534|NCT01878097|143340236|SUPERIORITY||F-stat|7.12||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
71909535|NCT01878097|143340237|SUPERIORITY||F-stat|7.18||||0.0003|TWO_SIDED||||||Mixed Models Analysis|||||||0.0003
71909536|NCT03325556|143340242|SUPERIORITY||Hazard Ratio (HR)|0.353|STANDARD_ERROR_OF_MEAN|0.3676||0.0023|TWO_SIDED|95.0|0.172|0.727||1-sided p-value reported. The protocol-defined O'Brien Flemming stopping boundary for the planned IA was a 1-sided p-value equal to 0.0033|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.727|0.172|0.0023
71909537|NCT03325556|143340243|SUPERIORITY||Hazard Ratio (HR)|0.452|STANDARD_ERROR_OF_MEAN|0.2812||0.0024|TWO_SIDED|95.0|0.261|0.785||1-sided p-value|Regression, Cox||Model included covariates for Treatment group, dementia subtype, and region, and robust sandwich-type variance estimator.|||0.785|0.261|0.0024
71909538|NCT02119026|143340244|SUPERIORITY|||||||0.967|||||||Mantel Haenszel|||||||0.967
71909539|NCT02119026|143340245|SUPERIORITY|||||||0.474|||||||Mantel Haenszel|||||||0.474
71909540|NCT02119026|143340246|SUPERIORITY|||||||0.464|||||||Mantel Haenszel|||||||0.464
71909541|NCT02119026|143340247|SUPERIORITY|||||||0.854|||||||Fisher Exact|||||||0.854
71909542|NCT02119026|143340248|SUPERIORITY|||||||0.728|||||||Mantel Haenszel|||||||0.728
71909543|NCT02119026|143340249|SUPERIORITY|||||||0.668|||||||Mantel Haenszel|||||||0.668
71909544|NCT02119026|143340250|SUPERIORITY|||||||0.618|||||||Mantel Haenszel|||||||0.618
71909545|NCT02119026|143340251|SUPERIORITY|||||||0.792||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.792
71909546|NCT02119026|143340252|SUPERIORITY|||||||0.371||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)|||||||0.371
71909547|NCT05034614|143340288|SUPERIORITY|||||||0.75|||||||Chi-squared|||||||.75
71909548|NCT03892707|143340292|SUPERIORITY|The between-group comparison on primary endpoint - change from baseline in pain intensity as measured on 0-10 points NRS scale at 10 days after the start of treatment was performed using analysis of covariance (ANCOVA). The difference between pain intensity at 10 days after the start of treatment and baseline (V3-V1) as response variable, treatment group as fixed factor and baseline pain intensity as a covariate was included into the model.|||||<|0.001|||||||ANCOVA|||"Since the superiority of one treatment over the other is investigated and taking into consideration that smaller negative values of the primary variable correspond to the greater reduction of pain, the statistical hypotheses are:~Null hypothesis (H0):~H0: μ2 - μ1 ≥ 0~Alternative hypothesis (HA):~HA: μ2 - μ1 \< 0, where μ1 и μ2 are the mean changes from baseline in pain intensity for (1) modern NSAIDs therapy and for (2) modern NSAIDs + Milgamma\\ Milgamma compositum therapy, correspondingly."||||<0.001
71909549|NCT03892707|143340293|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Changes from baseline in pain intensity measured on 0-10 points NRS scale at 5, 24 and 38 days after were compared between groups using ANCOVA models similar to those used for the analysis of the primary variable.||||<0.001
71909550|NCT03892707|143340294|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71909551|NCT03892707|143340295|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 2 (5 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 2)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
71909552|NCT03892707|143340295|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.|||||<|0.001|||||||Regression, Logistic|||For Visit 3 (10 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 3)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||<0.001
71909553|NCT03892707|143340295|SUPERIORITY|Between-group comparison was carried out using logistic regression with treatment group as fixed factor and baseline pain intensity as a covariate. Treatment effect was tested using the corresponding p-value.||||||0.061|||||||Regression, Logistic|||For Visit 4 (24 days after the start of treatment) relief in pain intensity was defined as 100%\*(pain intensity at baseline - pain intensity at Visit 4)/ pain intensity at baseline. The denominator for the proportion of patients was the number of patients with available pain intensity measurements after imputation using Last observation carried forward (LOCF) method.||||0.061
71909554|NCT03892707|143340296|SUPERIORITY||||||<|0.001|||||||ANCOVA|||Change from baseline in pain-related disability as measured by Roland Morris disability questionnaire at 10 days after the start of treatment was compared between groups using analysis of covariance (ANCOVA) model with treatment group as fixed factor and baseline value disability score as a covariate.||||<0.001
71909555|NCT03892707|143340297|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||Episode of pain flare-up was defined as presence of at least 1 day with pain following a period without pain lasting at least 4 weeks . The denominator for the proportion was the number of FAS patients who had at least one pain-free period with approximately 4 weeks duration registered during the study.||||<0.001
71909556|NCT03892707|143340298|SUPERIORITY||Difference in proportion|28.6|||||TWO_SIDED|95.0|-3.6|60.7||||||Difference in proportion of patients with at least one pain flare-up resulting in consultancy with physician||60.7|-3.6|
71909557|NCT03892707|143340298|SUPERIORITY||Difference in proportion|-17.1|||||TWO_SIDED|95.0|-51.6|17.4||||||Difference in proportion of patients with at least one pain flare-up resulting in disruption of daily activity||17.4|-51.6|
71909558|NCT03892707|143340298|SUPERIORITY||Difference in proportion|25.7|||||TWO_SIDED|95.0|-4.1|55.5||||||Difference in proportion of patients with at least one pain flare-up resulting in NSAIDs intake||55.5|-4.1|
71909559|NCT03892707|143340299|SUPERIORITY|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||NSAIDs intake during the study was analyzed. In order to calculate the total number of treatment days with NSAIDs, first, intersecting or adjacent records were collapsed, irrespective of the specific drug used; the duration of each of the resulting intake periods was determined as (End date - Start date + 1) and, finally, all individual duration values were summed up. In case medication intake was ongoing at the end of study, end date was imputed by the date of study completion.||||0.986
71909560|NCT03892707|143340302|SUPERIORITY|||||||0.921|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 5 days since the start of study treatment.||||0.921
71909561|NCT03892707|143340302|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 10 days since the start of study treatment||||0.051
71909562|NCT03892707|143340302|SUPERIORITY|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 38 days since the start of study treatment||||0.651
71909563|NCT03892707|143340302|SUPERIORITY|||||||0.106|||||||Wilcoxon (Mann-Whitney)|||Comparison of patient satisfaction with treatment between treatment groups after 3 months since the start of study treatment||||0.106
71909564|NCT02141217|143340378|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|1.5|||||TWO_SIDED|95.0|-4.9|8.0||||||||8.0|-4.9|
71909565|NCT02141217|143340379|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|0.9|||||TWO_SIDED|95.0|-5.6|7.4||||||||7.4|-5.6|
71909566|NCT02141217|143340380|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|2.3|||||TWO_SIDED|95.0|-4.4|9.0||||||||9.0|-4.4|
71909567|NCT01181141|143340395|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-3.5|||||TWO_SIDED|95.0|-18.8|6.0|||Wilcoxon (Mann-Whitney)|||||6.0|-18.8|
71909568|NCT01226706|143340401|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||"A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.~Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics."||||.016
71909569|NCT01226706|143340402|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.152
71909570|NCT01226706|143340403|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
71909571|NCT01226706|143340404|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.067
71909572|NCT01226706|143340408|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
71909573|NCT01226706|143340409|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.095
71909574|NCT01226706|143340410|SUPERIORITY_OR_OTHER|||||||0.038|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.038
71909575|NCT01226706|143340414|SUPERIORITY_OR_OTHER|||||||0.904|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.904
71909576|NCT01226706|143340415|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.080
71909577|NCT01226706|143340416|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
71909578|NCT01226706|143340420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.021|TWO_SIDED|95.0|-2.1|-0.2|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.2|-2.1|0.021
71909579|NCT01226706|143340421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.007|TWO_SIDED|95.0|-2.1|-0.5|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.5|-2.1|0.007
71681816|NCT00793624|142881807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|STANDARD_ERROR_OF_MEAN|0.04||0.6487||95.0|-0.06|0.096|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.096|-0.060|0.6487
71681817|NCT00793624|142881807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.04||0.9267||95.0|-0.074|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.081|-0.074|0.9267
71909580|NCT01226706|143340422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.013|TWO_SIDED|95.0|-2.0|-0.4|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||-0.4|-2.0|0.013
71909581|NCT01226706|143340423|SUPERIORITY_OR_OTHER|||||||0.173|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.173
71681818|NCT00793624|142881808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|STANDARD_ERROR_OF_MEAN|0.04||0.1603||95.0|-0.022|0.134|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.134|-0.022|0.1603
71681819|NCT00793624|142881808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.04||0.0399||95.0|0.004|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.160|0.004|0.0399
71863369|NCT01270828|143241260|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.61||||0.0901|TWO_SIDED|95.0|0.93|2.81|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio \> 1 was in favor of pregabalin CR.|This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.||2.81|0.93|0.0901
71863370|NCT00709228|143241276|SUPERIORITY_OR_OTHER||simple proportion|0.097|||||TWO_SIDED|95.0|0.06|0.15||||||||0.15|0.06|
71863371|NCT03322540|143241282|SUPERIORITY||Difference in Percentages|-6.5||||0.8|TWO_SIDED|95.0|-21.5|8.7|||Stratified Miettinen and Nurminen method|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Point estimate was assessed based on Miettinen \& Nurminen method stratified by predominant tumor histology (squamous vs non-squamous).|||8.7|-21.5|0.8000
71863372|NCT03445533|143241292|SUPERIORITY|||||||0.9394||||||p-value was calculated for percentage difference (B-A) using a Cochran-Mantel-Haenszel (CMH) test stratified by metastasis stage and BRAF mutation.|Cochran-Mantel-Haenszel|ORR and OS comprise a primary endpoint family; both have a priori hypotheses and were tested for statistical significance.||The ORR was defined as a percentage of subjects meeting criteria of CR and PR to calculate the p-value.||||0.9394
71863373|NCT03445533|143241293|SUPERIORITY||Cox Proportional Hazard|0.955||||0.6775|TWO_SIDED|95.0|0.77|1.186||The p-value was calculated using the log rank test stratified by metastasis stage and BRAF mutation.|Log Rank|ORR and OS comprise a primary endpoint family; both have a priori hypotheses. ORR will be tested first followed by OS.|Hazard ratio and 95% CI (B/A) are estimated using a Cox proportional hazards model stratified by metastasis stage and BRAF mutation.|||1.186|0.770|0.6775
71863374|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|3.959||0.9779|TWO_SIDED|90.0|-6.49|6.71|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.71|-6.49|0.9779
71863375|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|3.815||0.8801|TWO_SIDED|90.0|-5.79|6.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.94|-5.79|0.8801
71863376|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|3.845||0.9412|TWO_SIDED|90.0|-6.13|6.7|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.70|-6.13|0.9412
71863377|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|4.223||0.7486|TWO_SIDED|90.0|-8.38|5.66|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||5.66|-8.38|0.7486
71909582|NCT01226706|143340424|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
71863378|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|8.18|STANDARD_ERROR_OF_MEAN|4.171||0.0534|TWO_SIDED|90.0|1.24|15.12|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.12|1.24|0.0534
71863379|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|3.776||0.998|TWO_SIDED|90.0|-6.29|6.31|||Mixed Models Analysis|||Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.31|-6.29|0.9980
71863380|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|3.35|STANDARD_ERROR_OF_MEAN|3.958||0.4004|TWO_SIDED|90.0|-3.25|9.94|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||9.94|-3.25|0.4004
71863381|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|1.81|STANDARD_ERROR_OF_MEAN|4.214||0.6685|TWO_SIDED|90.0|-5.2|8.82|||Mixed Models Analysis|||Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||8.82|-5.20|0.6685
71909583|NCT01226706|143340425|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.051
71909584|NCT01226706|143340426|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.557
71681820|NCT00793624|142881808|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019|STANDARD_ERROR_OF_MEAN|0.04||0.6328||95.0|-0.059|0.098|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.098|-0.059|0.6328
71681821|NCT00793624|142881809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.04||0.127||95.0|-0.017|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.139|-0.017|0.1270
71909585|NCT01226706|143340427|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.029
71909586|NCT01226706|143340428|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
71909587|NCT01226706|143340429|SUPERIORITY_OR_OTHER|||||||0.085|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.085
71909588|NCT01226706|143340430|SUPERIORITY_OR_OTHER|||||||0.099|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.099
71909589|NCT01226706|143340431|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.132
71909590|NCT01226706|143340432|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.072
71909591|NCT01226706|143340433|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.230
71909592|NCT01226706|143340434|SUPERIORITY_OR_OTHER|||||||0.314|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.314
71909593|NCT01226706|143340435|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.013
71909594|NCT01226706|143340436|SUPERIORITY_OR_OTHER|||||||0.888|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||||||0.888
71909595|NCT01899677|143340441|SUPERIORITY_OR_OTHER|||||||0.32|||||||Mann whitney U|||Mann Whitney U test was used to compare cytokine levels between groups.||||0.32
71909596|NCT01899677|143340442|SUPERIORITY_OR_OTHER|||||||0.73|||||||Mann whitney U|||||||0.73
71909597|NCT01899677|143340443|SUPERIORITY_OR_OTHER|||||||0.66|||||||Mann whitney U|||||||0.66
71909598|NCT01899677|143340444|SUPERIORITY_OR_OTHER|||||||0.76|||||||Mann whitney U|||||||0.76
71909599|NCT00118911|143340459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.631|STANDARD_DEVIATION|7.337|<|0.03|TWO_SIDED|95.0|-8.3|-0.963|||ANCOVA|We used multiple imputation.||Hypothesis was that CBT would be superior to RES||-0.963|-8.30|<.03
71681822|NCT00793624|142881809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.04||0.1076||95.0|-0.014|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.014|0.1076
71909600|NCT00118911|143340460|SUPERIORITY_OR_OTHER||Slope|-0.12|STANDARD_DEVIATION|0.59|>|0.05|TWO_SIDED|95.0|-0.41|0.18|||Mixed Models Analysis||Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up|We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.||.18|-.41|>.05
71909601|NCT03037307|143340485|OTHER||Least square (LS) mean difference|2.76|||<|0.0001|TWO_SIDED|95.0|1.89|3.63||Treatment Comparison for study validity.|ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.63|1.89|<.0001
71909602|NCT03037307|143340486|OTHER||Least Square (LS) mean difference|2.12|||<|0.0001|TWO_SIDED|95.0|1.25|3.0|||ANCOVA|ANCOVA: factors for participant (random effect); period \& treatment, participant-level \& period-level pre-treatment baseline bite force as covariates|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.|||3.00|1.25|<.0001
71909603|NCT01700985|143340531|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71909604|NCT01700985|143340532|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
71909605|NCT01700985|143340533|SUPERIORITY||||||<|0.0001||||||At Day 15.|Fisher Exact|||||||<0.0001
71909606|NCT05067452|143340537|SUPERIORITY||Slope|-0.092|STANDARD_ERROR_OF_MEAN|0.721||0.9|TWO_SIDED|95.0|-1.59|1.4|||ANCOVA|||||1.40|-1.59|0.900
71909607|NCT05067452|143340538|SUPERIORITY||Slope|1.37|STANDARD_ERROR_OF_MEAN|0.945||0.146|TWO_SIDED|95.0|-0.478|3.23|||Mixed Models Analysis|||||3.23|-0.478|0.146
71909608|NCT05067452|143340539|SUPERIORITY||Risk Difference (RD)|0.235|STANDARD_ERROR_OF_MEAN|0.212||0.281|TWO_SIDED|95.0|-0.207|0.677|||ANCOVA|Linear regression used with the binary outcome (linear probability model)||||0.677|-0.207|0.281
71909609|NCT05067452|143340540|SUPERIORITY||Risk Difference (RD)|0.354|STANDARD_ERROR_OF_MEAN|0.211||0.094|TWO_SIDED|95.0|-0.06|0.768|||Mixed Models Analysis|Linear regression used with the binary outcome (linear probability model)||||0.768|-0.060|0.094
71909610|NCT05067452|143340541|SUPERIORITY||Slope|2.18|STANDARD_ERROR_OF_MEAN|5.11||0.669|TWO_SIDED|95.0|-7.83|12.2|||Mixed Models Analysis|||||12.2|-7.83|0.669
71909611|NCT05067452|143340542|SUPERIORITY||Slope|-0.024|STANDARD_ERROR_OF_MEAN|0.367||0.949|TWO_SIDED|95.0|-0.695|0.743|||Mixed Models Analysis|||||0.743|-0.695|0.949
71909612|NCT05067452|143340543|SUPERIORITY||Slope|-0.54|STANDARD_ERROR_OF_MEAN|0.53||0.308|TWO_SIDED|95.0|-1.58|0.679|||Mixed Models Analysis|||||0.679|-1.58|0.308
71909613|NCT05067452|143340544|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|1.91||0.593|TWO_SIDED|95.0|-4.77|0.499|||Mixed Models Analysis|||||0.499|-4.77|0.593
71909614|NCT05067452|143340545|SUPERIORITY||Slope|-2.63|STANDARD_ERROR_OF_MEAN|1.65||0.112|TWO_SIDED|95.0|-5.86|0.611|||Mixed Models Analysis|||||0.611|-5.86|0.112
71909615|NCT05067452|143340548|SUPERIORITY||Slope|-2.66|STANDARD_ERROR_OF_MEAN|2.85||0.349|TWO_SIDED|95.0|-8.25|2.92|||Mixed Models Analysis|||||2.92|-8.25|0.349
71909616|NCT03859960|143340549|OTHER|||||||0.006|||||||Pearson correlation test|||||||0.006
71909617|NCT03859960|143340549|OTHER|||||||0.23||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.23
71909618|NCT03859960|143340550|OTHER|||||||0.001||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.001
71909619|NCT03859960|143340550|OTHER|||||||0.731|||||||Pearson correlation test|||||||0.731
71909620|NCT03859960|143340551|OTHER|||||||0.214|||||||Pearson correlation test|||||||0.214
71909621|NCT03859960|143340551|OTHER|||||||0.993||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.993
71909622|NCT03859960|143340552|OTHER|||||||0.41|||||||Pearson correlation test|||||||0.41
71909623|NCT03859960|143340552|OTHER|||||||0.676|||||||Pearson correlation test|||||||0.676
71909624|NCT03859960|143340553|OTHER|||||||0.511||||||p\<0.05 was considered statisticaly significant.|Pearson correlation test|||||||0.511
71909625|NCT03859960|143340553|OTHER|||||||0.248|||||||Pearson correlation test|||||||0.248
71909626|NCT03859960|143340554|OTHER|||||||0.654|||||||Pearson correlation test|||||||0.654
71909627|NCT03859960|143340554|OTHER|||||||0.025|||||||Pearson correlation test|||||||0.025
71909628|NCT00067470|143340555|SUPERIORITY_OR_OTHER||Mean Difference (Net)|92.0|STANDARD_ERROR_OF_MEAN|40.0||0.025||95.0|11.0|172.0|||Regression, Linear|||||172|11|0.025
71909629|NCT00067470|143340556|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|2.9||0.053||95.0|-0.1|11.5|||Regression, Linear|The raw data were adjusted for the observed differences in baseline between the groups and fitted to a longitudinal repeated measures linear model.||||11.5|-0.1|0.053
71681823|NCT00793624|142881809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1492||95.0|-0.021|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.137|-0.021|0.1492
71909630|NCT01192204|143340571|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED|||||Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|We used a 2-tailed Mann Whitney U test to evaluate these data.||Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)||||0.048
71909631|NCT01192204|143340571|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED|||||Statistical analyses reflect percent change pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|||Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)||||0.50
71909632|NCT01192204|143340572|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|specifically, we used the Wilcoxon matched-pairs signed rank test.||||||<0.002
71909633|NCT01192204|143340572|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Wilcoxon matched-pairs signed rank test|||||||0.036
71909634|NCT01192204|143340573|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||2-tailed unpaired t test|||||||0.002
71909635|NCT01192204|143340573|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||two-tailed unpaired t test|||||||0.16
71909636|NCT02146248|143340574|SUPERIORITY_OR_OTHER|||||||0.4795||||||The two-tailed P value equals 0.4795|McNemar|||McNemar paired. Hypothesis is no change in tubal patency status. All subjects know to have bilateral patency in one of the exams during natural cycle||||0.4795
71909637|NCT03589885|143340587|SUPERIORITY||Odds Ratio (OR)|1014.07|||<|0.0001|TWO_SIDED|95.0|68.83|14940.62|||Regression, Logistic|||PASI 75||14940.62|68.83|<0.0001
71909638|NCT03589885|143340587|SUPERIORITY||Odds Ratio (OR)|96.23|||<|0.0001|TWO_SIDED|95.0|17.22|537.78|||Regression, Logistic|||PASI 75||537.78|17.22|<0.0001
71909639|NCT03589885|143340588|SUPERIORITY||Odds Ratio (OR)|51.46|||<|0.0001|TWO_SIDED|95.0|11.95|221.64|||Regression, Logistic|||||221.64|11.95|<0.0001
71909640|NCT03589885|143340588|SUPERIORITY||Odds Ratio (OR)|29.7|||<|0.0001||95.0|7.38|119.57|||Regression, Logistic|||||119.57|7.38|<0.0001
71909641|NCT03589885|143340589|SUPERIORITY||Odds Ratio (OR)|88.46|||<|0.0001|TWO_SIDED|95.0|16.15|484.52|||Regression, Logistic|||||484.52|16.15|<0.0001
71909642|NCT03589885|143340589|SUPERIORITY||Odds Ratio (OR)|37.9|||<|0.0001|TWO_SIDED|95.0|7.6|189.01|||Regression, Logistic|||||189.01|7.60|<0.0001
71909643|NCT01861054|143340633|OTHER|||||||0.3149||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Comparison on ALDH+ cells by ALDEFLUOR assay||||0.3149
71909644|NCT01861054|143340633|OTHER|||||||0.8148||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Comparison on CD44+/CD24- by flow citometry||||0.8148
71909645|NCT01861054|143340634|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho AKT Extent||||>0.9999
71909646|NCT01861054|143340634|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-AKT Intensity||||>0.9999
71909647|NCT01861054|143340634|OTHER|||||||0.2245|||||||Wilcoxon (Mann-Whitney)|||AKT Extent||||0.2245
71909648|NCT01861054|143340634|OTHER|||||||0.5785|||||||Wilcoxon (Mann-Whitney)|||AKT Intensity||||0.5785
71909649|NCT01861054|143340634|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Extent||||>0.9999
71909650|NCT01861054|143340634|OTHER|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||Phospho-FAK Intensity||||0.3139
71909651|NCT01861054|143340634|OTHER|||||||0.212|||||||Wilcoxon (Mann-Whitney)|||FAK Extent||||0.2120
71909652|NCT01861054|143340634|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||FAK Intensity||||>0.9999
71863382|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|4.522||0.2968|TWO_SIDED|90.0|-2.77|12.25|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.25|-2.77|0.2968
71681824|NCT00793624|142881810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.04||0.0385||95.0|0.004|0.162|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.162|0.004|0.0385
71863383|NCT00945672|143241375|SUPERIORITY_OR_OTHER_LEGACY||L S Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|4.494||0.772|TWO_SIDED|90.0|-8.77|6.16|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||6.16|-8.77|0.7720
71863384|NCT00945672|143241376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|8.789||0.8205|TWO_SIDED|90.0|-12.68|16.69|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||16.69|-12.68|0.8205
71863385|NCT00945672|143241376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|11.37|STANDARD_ERROR_OF_MEAN|8.789||0.2007|TWO_SIDED|90.0|-3.31|26.06|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||26.06|-3.31|0.2007
71863386|NCT00945672|143241376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|8.9|STANDARD_ERROR_OF_MEAN|0.8789||0.3152|TWO_SIDED|90.0|-5.78|23.59|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||23.59|-5.78|0.3152
71863387|NCT00945672|143241376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|8.964||0.8071|TWO_SIDED|90.0|-17.18|12.79|||Mixed Models Analysis|||Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.79|-17.18|0.8071
71863388|NCT00945672|143241376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|9.354||0.9918|TWO_SIDED|90.0|-15.72|15.52|||Mixed Models Analysis|||Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||15.52|-15.72|0.9918
71863389|NCT00945672|143241376|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.01|STANDARD_ERROR_OF_MEAN|9.415||0.7498|TWO_SIDED|90.0|-18.73|12.7|||Mixed Models Analysis|||Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.||12.70|-18.73|0.7498
71863390|NCT00945672|143241377|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|1.91||0.4855|TWO_SIDED|90.0|-1.9|4.6|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||4.60|-1.90|0.4855
71863391|NCT00945672|143241377|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.45|STANDARD_ERROR_OF_MEAN|2.185||0.5132|TWO_SIDED|90.0|-2.27|5.16|||ANCOVA|||Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.||5.16|-2.27|0.5132
71863392|NCT03926195|143241392|OTHER||Difference in Percentage|5.8|||||TWO_SIDED|95.0|-7.5|19.2|||||Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test.|||19.2|-7.5|
71863393|NCT03926195|143241394|OTHER||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-6.4|3.5|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||3.5|-6.4|
71909653|NCT01861054|143340634|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Extent||||>0.9999
71909654|NCT01861054|143340634|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||C-PTEN Intensity||||0.8728
71863394|NCT03926195|143241396|OTHER||Median Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-37.1|36.8|||||Difference in medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||36.8|-37.1|
71863395|NCT03926195|143241398|OTHER||Median Difference (Final Values)|7.4|||||TWO_SIDED|95.0|-6.0|20.8|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||20.8|-6.0|
71863396|NCT03926195|143241400|OTHER||Median Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-0.6|0.1|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||0.1|-0.6|
71863397|NCT03926195|143241402|OTHER||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-3.0|1.0|||||Difference in Medians and 95% CI for change from baseline at Week 13 was based on quantile regression.|||1|-3|
71863398|NCT00479882|143241419|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least squares mean|2.4|||||TWO_SIDED|95.0|1.3|3.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||3.4|1.3|
71863399|NCT00479882|143241419|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least Squares Mean|1.4|||||TWO_SIDED|95.0|0.4|2.4|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||2.4|0.4|
71863400|NCT00479882|143241420|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.2|||||TWO_SIDED|95.0|-1.4|1.0|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||1.0|-1.4|
71863401|NCT00479882|143241420|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.8|||||TWO_SIDED|95.0|-1.9|0.2|||ANOVA|Factors for sequence, participant within sequence, period and treatment||||0.2|-1.9|
71863402|NCT00479882|143241421|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.685|TWO_SIDED|95.0|-1.2|0.8|||Fisher Exact||Wilson's Method|Periods I/II||0.8|-1.2|0.685
71863403|NCT00479882|143241421|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||Wilson's Method|Period III||1.1|-1.8|
71909655|NCT01861054|143340634|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Extent||||>0.9999
71909656|NCT01861054|143340634|OTHER|||||||0.8728|||||||Wilcoxon (Mann-Whitney)|||D-PTEN Intensity||||0.8728
71681825|NCT00793624|142881810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.142||95.0|-0.02|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.138|-0.020|0.1420
71681826|NCT00793624|142881810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.04||0.0965||95.0|-0.012|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.147|-0.012|0.0965
71681827|NCT00793624|142881811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.04||0.1394||95.0|-0.019|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.138|-0.019|0.1394
71863404|NCT00479882|143241421|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.753|TWO_SIDED|95.0|-1.6|0.9|||Fisher Exact||Wilson's Method|Periods I/II||0.9|-1.6|0.753
71863405|NCT00479882|143241421|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.8|1.4|||||Wilson's Method|Period III||1.4|-0.8|
71863406|NCT00479882|143241422|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
71863407|NCT00479882|143241422|SUPERIORITY_OR_OTHER||Difference in Percentage|0.4|||||TWO_SIDED|95.0|-0.5|1.5|||||Wilson's Method|Period III||1.5|-0.5|
71863408|NCT00479882|143241422|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.617|TWO_SIDED|95.0|-0.6|1.1|||Fisher Exact||Wilson's Method|Periods I/II||1.1|-0.6|0.617
71863409|NCT00479882|143241422|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
71863410|NCT00479882|143241423|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
71863411|NCT00479882|143241423|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
71863412|NCT00479882|143241423|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
71863413|NCT00479882|143241423|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
71863414|NCT00479882|143241424|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-0.7|
71863415|NCT00479882|143241424|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.9|0.8|||||Wilson's Method|Period III||0.8|-0.9|
71863416|NCT00479882|143241424|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.7|||Fisher Exact||Wilson's Method|Periods I/II||0.7|-0.6|
71863417|NCT00479882|143241424|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.8|0.9|||||Wilson's Method|Period III||0.9|-0.8|
71863418|NCT00479882|143241425|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2||||0.497|TWO_SIDED|95.0|-0.9|0.5|||Fisher Exact|||Periods I/II||0.5|-0.9|0.497
71863419|NCT00479882|143241426|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3||||0.449|TWO_SIDED|95.0|-1.4|0.6|||Fisher Exact||Wilson's Method|Periods I/II||0.6|-1.4|0.449
71863420|NCT00479882|143241426|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
71863421|NCT00479882|143241426|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2||||0.685|TWO_SIDED|95.0|-0.8|1.2|||Fisher Exact||Wilson's Method|Period I/II||1.2|-0.8|0.685
71909657|NCT01861054|143340634|OTHER|||||||0.2265|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Extent||||0.2265
71863422|NCT00479882|143241426|SUPERIORITY_OR_OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-1.0|1.6|||||Wilson's Method|Period III||1.6|-1.0|
71863423|NCT00479882|143241427|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.2||||0.02|TWO_SIDED|95.0|-2.4|-0.2|||Fisher Exact||Wilson's Method|Periods I/II||-0.2|-2.4|0.020
71863424|NCT00479882|143241427|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.3|||||TWO_SIDED|95.0|-1.6|0.9|||||Wilson's Method|Period III||0.9|-1.6|
71863425|NCT00479882|143241427|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.5||||0.452|TWO_SIDED|95.0|-1.6|0.5|||Fisher Exact||Wilson's Method|Periods I/II||0.5|-1.6|0.452
71863426|NCT00479882|143241427|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.4|||||TWO_SIDED|95.0|-1.9|1.0|||||Wilson's Method|Period III||1.0|-1.9|
71863427|NCT00479882|143241428|SUPERIORITY_OR_OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Wilson's Method|Periods I/II||0.6|-0.6|
71863428|NCT00479882|143241428|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.7|1.2|||||Wilson's Method|Period III||1.2|-0.7|
71863429|NCT00479882|143241428|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Method|Periods I/II||0.9|-0.5|
71863430|NCT00479882|143241428|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.6|1.3|||||Wilson's Method|Period III||1.3|-0.6|
71863431|NCT00479882|143241429|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.4|||||TWO_SIDED|95.0|-6.6|3.8|||||Wilson's Score Method|Periods I/II||3.8|-6.6|
71863432|NCT00479882|143241429|SUPERIORITY_OR_OTHER||Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-8.1|4.3|||||Wilson's Score Method|Period III||4.3|-8.1|
71863433|NCT00479882|143241429|SUPERIORITY_OR_OTHER||Difference in Percentage|0.1|||||TWO_SIDED|95.0|-5.2|5.3|||||Wilson's Score Method|Periods I/II||5.3|-5.2|
71863434|NCT00479882|143241429|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8|||||TWO_SIDED|95.0|-8.9|3.4|||||Wilson's Score Method|Period III||3.4|-8.9|
71863435|NCT00479882|143241430|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-2.5|2.1|||||Wilson's Score Method|Periods I/II||2.1|-2.5|
71863436|NCT00479882|143241430|SUPERIORITY_OR_OTHER||Difference in Percentage|2.3|||||TWO_SIDED|95.0|-0.5|5.2|||||Wilson's Score Method|Period III||5.2|-0.5|
71863437|NCT00479882|143241430|SUPERIORITY_OR_OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-1.0|4.2|||||Wilson's Score Method|Periods I/II||4.2|-1.0|
71863438|NCT00479882|143241430|SUPERIORITY_OR_OTHER||Difference in Percentage|2.0|||||TWO_SIDED|95.0|-0.8|5.0|||||Wilson's Score Method|Period III||5.0|-0.8|
71863439|NCT00479882|143241433|SUPERIORITY_OR_OTHER||Difference in Percentage|0.2|||||TWO_SIDED|95.0|-0.5|0.9|||||Wilson's Score Method|Periods I/II||0.9|-0.5|
71863440|NCT00479882|143241433|SUPERIORITY_OR_OTHER||Difference in Percentage|-0.2|||||TWO_SIDED|95.0|-0.9|0.5|||||Wilson's Score Method|Periods I/II||0.5|-0.9|
71681828|NCT00793624|142881811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.04||0.1532||95.0|-0.022|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.137|-0.022|0.1532
71863441|NCT00479882|143241434|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.0||||0.341|TWO_SIDED|95.0|-1.1|3.1|||ANOVA|Factors for treatment, country and gender||||3.1|-1.1|0.341
71863442|NCT00479882|143241434|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|3.7||||0.004|TWO_SIDED|95.0|1.2|6.1|||ANOVA|Factors for treatment, country and gender.||||6.1|1.2|0.004
71863443|NCT00479882|143241435|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.4||||0.69|TWO_SIDED|95.0|-2.3|1.5|||ANOVA|Factors for treatment, country and gender||||1.5|-2.3|0.690
71863444|NCT00479882|143241435|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|0.2||||0.879|TWO_SIDED|95.0|-1.9|2.3|||ANOVA|Factors for treatment, country and gender||||2.3|-1.9|0.879
71863445|NCT03738475|143241436|SUPERIORITY|||||||0.0056||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0056
71863446|NCT03738475|143241440|SUPERIORITY|||||||0.0799||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.0799
71863447|NCT03738475|143241442|SUPERIORITY|||||||0.289||||||Based on Wilcoxon Rank Sum test for the change from baseline between treatment groups.|Wilcoxon Rank Sum test|||||||0.2890
71909658|NCT01861054|143340634|OTHER|||||||0.2403|||||||Wilcoxon (Mann-Whitney)|||CXCR1 Intensity||||0.2403
71909659|NCT01861054|143340635|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 1 Beta||||>0.9999
71909660|NCT01861054|143340635|OTHER|||||||0.6945||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups|Wilcoxon (Mann-Whitney)|||Interleukin 6||||0.6945
71909661|NCT01861054|143340635|OTHER|||||||0.9448||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Interleukin 8||||0.9448
71681829|NCT00793624|142881811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.041||0.5511||95.0|-0.055|0.104|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.104|-0.055|0.5511
71863448|NCT01370655|143241466|NON_INFERIORITY_OR_EQUIVALENCE|"Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is~≤0 mmHg"|Difference in Least square (LS) means|-7.4|||||TWO_SIDED|80.0|-10.6|-4.1|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||-4.1|-10.6|
71909662|NCT01861054|143340635|OTHER|||||||0.6292||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Tumor Necrosis Factor - alpha||||0.6292
71909663|NCT01861054|143340635|OTHER|||||||0.2354||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Granulocyte Macrophage Colony Stm Factor||||0.2354
71909664|NCT01861054|143340635|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Vascular Endothelial Growth Factor||||>0.9999
71909665|NCT01861054|143340635|OTHER|||||||0.4719||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|Wilcoxon (Mann-Whitney)|||Basic Fibroblast Growth Factor||||0.4719
71909666|NCT01861054|143340636|OTHER|||||||0.0951|||||||Wilcoxon (Mann-Whitney)|||CD31 Extent||||0.0951
71909667|NCT01861054|143340636|OTHER|||||||0.1643|||||||Wilcoxon (Mann-Whitney)|||CD31 Intensity||||0.1643
71681830|NCT00793624|142881812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.264|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.264|0.108|<0.0001
71863449|NCT01370655|143241466|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the upper bound of the two-sided 90% CI (equivalent to a one-sided upper 95% CI) for the difference ≤ 3.8 mmHg.|Difference in LS means|-5.4|||||TWO_SIDED|90.0|-9.2|-1.6|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|Type I error rate of alpha=0.05 (1-sided) is specified for testing of the hypothesis.||-1.6|-9.2|
71863450|NCT01370655|143241466|SUPERIORITY_OR_OTHER||Difference in LS means|-4.8|||||TWO_SIDED|90.0|-9.0|-0.5|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.5|-9.0|
71863451|NCT01370655|143241466|SUPERIORITY_OR_OTHER||Difference in LS Means|-6.7|||||TWO_SIDED|90.0|-11.2|-2.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-2.2|-11.2|
71863452|NCT01370655|143241466|SUPERIORITY_OR_OTHER||Difference in LS Means|-1.9|||||TWO_SIDED|90.0|-6.2|2.3|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.3|-6.2|
71863453|NCT01370655|143241467|SUPERIORITY_OR_OTHER||Difference in LS means|-3.2|||||TWO_SIDED|90.0|-6.1|-0.3|||||MK-7145 6 mg LS mean minus Placebo LS mean|||-0.3|-6.1|
71863454|NCT01370655|143241467|SUPERIORITY_OR_OTHER||Difference in LS means|-2.9|||||TWO_SIDED|90.0|-5.5|-0.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||-0.2|-5.5|
71863455|NCT01370655|143241467|SUPERIORITY_OR_OTHER||Difference in LS means|-3.0|||||TWO_SIDED|90.0|-6.0|-0.1|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-0.1|-6.0|
71909668|NCT01861054|143340637|OTHER|||||||0.4183|||||||Wilcoxon (Mann-Whitney)|||P62 Extent||||0.4183
71909669|NCT01861054|143340637|OTHER|||||||0.3702|||||||Wilcoxon (Mann-Whitney)|||P62 Intensity||||0.3702
71909670|NCT01861054|143340642|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Lymphocyte in WBC||||0.6168
71909671|NCT01861054|143340642|OTHER|||||||0.6168||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Total T cell in lymphocytes||||0.6168
71909672|NCT01861054|143340642|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||B cell in lymphocytes||||0.1453
71909673|NCT01861054|143340642|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||T-helper cell in lymphocytes||||0.1453
71863456|NCT01370655|143241467|SUPERIORITY_OR_OTHER||Difference in LS means|-3.4|||||TWO_SIDED|90.0|-6.5|-0.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||-0.2|-6.5|
71909674|NCT01861054|143340642|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CTL in lymphocytes||||0.1453
71909675|NCT01861054|143340642|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||NKT cell in lymphocytes||||>0.9999
71909676|NCT01861054|143340642|OTHER|||||||0.7634||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||ADCC NK subsets in lymphocytes||||0.7634
71909677|NCT01861054|143340642|OTHER|||||||0.5487||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Regulatory NK subsets in lymphocytes||||0.5487
71909678|NCT01861054|143340642|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Exhausted NK subsets in lymphocytes||||>0.9999
71909679|NCT01861054|143340642|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD56-CD16+ NK subsets in lymphocytes||||>0.9999
71909680|NCT01861054|143340642|OTHER|||||||0.1451||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - IL-8||||0.1451
71681831|NCT00793624|142881812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.128|0.284|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.284|0.128|<0.0001
71863457|NCT01370655|143241467|SUPERIORITY_OR_OTHER||Difference in LS means|-0.3|||||TWO_SIDED|90.0|-3.3|2.7|||||HCTZ 25 mg LS mean minus Placebo LS mean|||2.7|-3.3|
71909681|NCT01861054|143340642|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - IL-8||||0.2779
71909682|NCT01861054|143340642|OTHER|||||||0.1444||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - IL-8||||0.1444
71909683|NCT01861054|143340642|OTHER|||||||0.1453||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - IL-8||||0.1453
71909684|NCT01861054|143340642|OTHER|||||||0.92||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - IL-8||||0.9200
71909685|NCT01861054|143340642|OTHER|||||||0.2779||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD11b in PMNs - US||||0.2779
71909686|NCT01861054|143340642|OTHER|||||||0.6164||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||CD18 in PMNs - US||||0.6164
71909687|NCT01861054|143340642|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD11b - US||||>0.9999
71909688|NCT01861054|143340642|OTHER|||||||0.2032||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD66b - US||||0.2032
71863458|NCT01370655|143241468|NON_INFERIORITY_OR_EQUIVALENCE|Hypothesis supported if the lower bound of the two-sided 80% CI (equivalent to a one-sided lower 90% CI) is \> 89.0 mmol/day.|Difference in LS means|76.5|||||TWO_SIDED|80.0|49.2|103.8|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.||103.8|49.2|
71863459|NCT01370655|143241468|SUPERIORITY_OR_OTHER||Difference in LS means|-63.7|||||TWO_SIDED|90.0|-100.8|-26.7|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||-26.7|-100.8|
71863460|NCT01370655|143241468|SUPERIORITY_OR_OTHER||Difference in LS means|-18.1|||||TWO_SIDED|90.0|-49.1|12.9|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||12.9|-49.1|
71909689|NCT01861054|143340642|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||MFI of CD18 - US||||>0.9999
71909690|NCT01861054|143340642|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - IL-8||||0.5250
71909691|NCT01861054|143340642|OTHER|||||||0.6706||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - IL-8||||0.6706
71909692|NCT01861054|143340642|OTHER|||||||0.8312||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - IL-8||||0.8312
71909693|NCT01861054|143340642|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - IL-8||||0.3992
71909694|NCT01861054|143340642|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - IL-8||||0.2952
71909695|NCT01861054|143340642|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - IL-8||||0.3992
71909696|NCT01861054|143340642|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - IL-8||||0.2952
71909697|NCT01861054|143340642|OTHER|||||||0.525||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - IL-8||||0.5250
71909698|NCT01861054|143340642|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - US||||0.3992
71909699|NCT01861054|143340642|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - US||||0.2952
71681832|NCT00793624|142881812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.205|0.361|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.361|0.205|<0.0001
71681833|NCT00793624|142881813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.131|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.131|<0.0001
71681834|NCT00793624|142881813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.231|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.310|0.153|<0.0001
71681835|NCT00793624|142881813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.187|0.344|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.344|0.187|<0.0001
71863461|NCT01370655|143241468|SUPERIORITY_OR_OTHER||Difference in LS means|30.9|||||TWO_SIDED|90.0|-7.0|68.7|||||MK-7145 3 mg LS mean minus Placebo LS mean|||68.7|-7.0|
71681836|NCT00793624|142881814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|0.108|0.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.267|0.108|<0.0001
71863462|NCT01370655|143241468|SUPERIORITY_OR_OTHER||Difference in LS means|94.6|||||TWO_SIDED|90.0|58.8|130.4|||||HCTZ 25 mg LS mean minus Placebo LS mean|||130.4|58.8|
71863463|NCT01370655|143241472|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|7.9|||||TWO_SIDED|80.0|-2.3|18.2|||||MK-7145 3 mg LS mean minus Placebo LS mean|||18.2|-2.3|
71863464|NCT01370655|143241472|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is \<13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 - placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|1.1|||||TWO_SIDED|80.0|-8.5|10.7|||||MK-7145 6 mg LS mean minus Placebo LS mean|||10.7|-8.5|
71863465|NCT01370655|143241472|SUPERIORITY_OR_OTHER||Difference in LS means|3.0|||||TWO_SIDED|90.0|-9.6|15.6|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean|||15.6|-9.6|
71863466|NCT01370655|143241472|SUPERIORITY_OR_OTHER||Difference in LS means|-3.9|||||TWO_SIDED|90.0|-15.0|7.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|||7.2|-15.0|
71863467|NCT01370655|143241472|SUPERIORITY_OR_OTHER||Difference in LS means|5.0|||||TWO_SIDED|90.0|-7.7|17.6|||||HCTZ 25 mg LS mean minus Placebo LS mean|||17.6|-7.7|
71863468|NCT01993849|143241513|SUPERIORITY||Mean Difference (Final Values)|0.61||||0.69|TWO_SIDED|95.0|-3.81|2.59||The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||||2.59|-3.81|0.69
71863469|NCT03443414|143241514|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.139|||<|0.001|TWO_SIDED|95.0|0.069|0.21|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.210|0.069|<0.001
71863470|NCT03443414|143241514|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.2|||<|0.001|TWO_SIDED|95.0|0.131|0.27|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.270|0.131|<0.001
71863471|NCT03443414|143241514|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.153|||<|0.001|TWO_SIDED|95.0|0.083|0.222|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.222|0.083|<0.001
71863472|NCT03443414|143241514|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.146|||<|0.001|TWO_SIDED|95.0|0.075|0.216|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.216|0.075|<0.001
71863473|NCT03443414|143241515|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.002|||=|0.953|TWO_SIDED|95.0|-0.061|0.065|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).||0.065|-0.061|=0.953
71863474|NCT03443414|143241515|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.068|||=|0.032|TWO_SIDED|95.0|0.006|0.13|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).||0.130|0.006|=0.032
71863475|NCT03443414|143241515|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.009|||=|0.773|TWO_SIDED|95.0|-0.053|0.072|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).||0.072|-0.053|=0.773
71863476|NCT03443414|143241515|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.035|||=|0.272|TWO_SIDED|95.0|-0.028|0.099|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).||0.099|-0.028|=0.272
71863477|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.087|||<|0.001|TWO_SIDED|95.0|0.045|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Day 1.||0.129|0.045|<0.001
71909700|NCT01861054|143340642|OTHER||||||>|0.9999||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - US||||>0.9999
71909701|NCT01861054|143340642|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - US||||0.3992
71909702|NCT01861054|143340642|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - US||||0.3992
71909703|NCT01861054|143340642|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - US||||0.2952
71681837|NCT00793624|142881814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.159|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.318|0.159|<0.0001
71681838|NCT00793624|142881814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.177|0.336|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.336|0.177|<0.0001
71681839|NCT00793624|142881815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.173|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.092|0.253|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.253|0.092|<0.0001
71681840|NCT00793624|142881815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.127|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.127|<0.0001
71681841|NCT00793624|142881815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.137|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.298|0.137|<0.0001
71681842|NCT00793624|142881816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.041||0.0003||95.0|0.07|0.231|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.231|0.070|0.0003
71681843|NCT00793624|142881816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001||95.0|0.096|0.259|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.259|0.096|<0.0001
71681844|NCT00793624|142881816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.141|0.304|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.304|0.141|<0.0001
71681845|NCT00793624|142881817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.067|STANDARD_ERROR_OF_MEAN|4.639||0.0012|TWO_SIDED|95.0|5.962|24.173|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.173|5.962|0.0012
71681846|NCT00793624|142881817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.999|STANDARD_ERROR_OF_MEAN|4.611||0.0012||95.0|5.949|24.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||24.049|5.949|0.0012
71681847|NCT00793624|142881817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.642|STANDARD_ERROR_OF_MEAN|4.601||0.0001|TWO_SIDED|95.0|8.61|26.673|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR||26.673|8.610|0.0001
71681848|NCT00793624|142881817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.721|STANDARD_ERROR_OF_MEAN|4.606||0.0001|TWO_SIDED|95.0|8.68|26.762|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.762|8.680|0.0001
71681849|NCT00793624|142881817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.471|STANDARD_ERROR_OF_MEAN|4.579|<|0.0001|TWO_SIDED|95.0|9.484|27.458|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||27.458|9.484|<0.0001
71909704|NCT01861054|143340642|OTHER|||||||0.3992||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - US||||0.3992
71863478|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.053|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Day 1.||0.137|0.053|<0.001
71681850|NCT00793624|142881817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.873|STANDARD_ERROR_OF_MEAN|4.548|<|0.0001|TWO_SIDED|95.0|8.947|26.799|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR||26.799|8.947|<0.0001
71681851|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.403|STANDARD_ERROR_OF_MEAN|0.133||0.0026|TWO_SIDED|95.0|-0.665|-0.141|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.141|-0.665|0.0026
71909705|NCT01861054|143340642|OTHER|||||||0.2952||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - US||||0.2952
71909706|NCT01861054|143340642|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS||||0.2238
71681852|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.327|STANDARD_ERROR_OF_MEAN|0.133||0.0141|TWO_SIDED|95.0|-0.587|-0.066|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||-0.066|-0.587|0.0141
71681853|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.147|STANDARD_ERROR_OF_MEAN|0.132||0.2677|TWO_SIDED|95.0|-0.406|0.113|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use||0.113|-0.406|0.2677
71909707|NCT01861054|143340642|OTHER|||||||0.2238||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS||||0.2238
71909708|NCT01861054|143340642|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS||||0.1543
71909709|NCT01861054|143340642|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS||||0.1547
71909710|NCT01861054|143340642|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS||||0.1547
71909711|NCT01861054|143340642|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS||||0.1547
71909712|NCT01861054|143340642|OTHER|||||||0.4314||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS||||0.4314
71909713|NCT01861054|143340642|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS||||0.3153
71909714|NCT01861054|143340642|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL6 - LPS+IL-8||||0.4700
71909715|NCT01861054|143340642|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL1b - LPS+IL-8||||0.1605
71909716|NCT01861054|143340642|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing IL8 - LPS+IL-8||||0.1605
71909717|NCT01861054|143340642|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Monocytes expressing TNFa - LPS+IL-8||||0.1605
71909718|NCT01861054|143340642|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL6 - LPS+IL-8||||0.1547
71909719|NCT01861054|143340642|OTHER|||||||0.1547||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL1b - LPS+IL-8||||0.1547
71909720|NCT01861054|143340642|OTHER|||||||0.3153||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing IL8 - LPS+IL-8||||0.3153
71909721|NCT01861054|143340642|OTHER|||||||0.1543||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent Neutrophils expressing TNFa - LPS+IL-8||||0.1543
71909722|NCT01861054|143340642|OTHER|||||||0.1601||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Control||||0.1601
71909723|NCT01861054|143340642|OTHER|||||||0.2368||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent FITC eColi Test||||0.2368
71909724|NCT01861054|143340642|OTHER|||||||0.1605||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs unstimulated||||0.1605
71909725|NCT01861054|143340642|OTHER|||||||0.47||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent PMNs fMLP||||0.4700
71909726|NCT01861054|143340642|OTHER|||||||0.3392||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin unstimulated||||0.3392
71909727|NCT01861054|143340642|OTHER|||||||0.808||||||P-Value is based on two-sample t-test or Wilcoxon Rank-Sum test, where appropriate, comparing the 2 study groups.|t-test, 2 sided|||Percent L-selectin fMLP||||0.8080
71909728|NCT00405821|143340643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75|||<|0.05|TWO_SIDED|95.0|0.58|0.99||P-value was adjusted to include multiple looks at data including an interim efficacy review at 50% and 75% accrual of person-years on study|Regression, Cox|adjusted for baseline log10 viral load, baseline CD4 count, gender, and age||Intent-to-treat analysis used Cox proportional hazards (CPH) models, adjusting for baseline log10 viral load (VL), CD4 cell count, gender and age to assess the risk of disease progression||0.99|0.58|<0.05
71909729|NCT00405821|143340644|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31|||<|0.05|TWO_SIDED|95.0|0.19|0.48||we included multiple GUD events per subject in the estimate of GUD incidence|rate ratio with 95% CI|||Null hypothesis is no difference by treatment arm in rate of GUD.||0.48|0.19|<0.05
71909730|NCT00405821|143340645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.463||||0.05|TWO_SIDED|95.0|-0.731|-0.194|||t-test, 2 sided|||Null hypothesis is no difference in annual rate of change in log10 viral load by arm.||-0.194|-0.731|0.05
71909731|NCT04962503|143340649|OTHER|||||||0.0313||||||Change from baseline to Day 3|Wilcoxon (Mann-Whitney)|||||||0.0313
71909732|NCT04962503|143340649|OTHER|||||||0.0625||||||Change from baseline to Day 9|Wilcoxon (Mann-Whitney)|||||||0.0625
71909733|NCT01769469|143340657|OTHER|||||||0.2085|||||||Wilcoxon (Mann-Whitney)|||Test of difference at Week 48 from baseline||||0.2085
71909734|NCT01769469|143340661|SUPERIORITY|||||||0.2452|||||||Wilcoxon Signed Rank Test|||||||0.2452
71909735|NCT01769469|143340669|SUPERIORITY|||||||0.0806|||||||Wilcoxon Signed Rank Test|||||||.0806
71909736|NCT01769469|143340680|OTHER|||||||0.6545|||||||Wilcoxon Signed Rank Test|||||||0.6545
71909737|NCT01769469|143340684|OTHER|||||||0.8739|||||||Wilcoxon Signed Rank Test|||||||0.8739
71909738|NCT01769469|143340692|OTHER|||||||0.5014|||||||Wilcoxon Signed Rank Test|||||||0.5014
71681854|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.602|STANDARD_ERROR_OF_MEAN|0.171||0.0005|TWO_SIDED|95.0|-0.939|-0.266|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.266|-0.939|0.0005
71909739|NCT01769469|143340693|OTHER|||||||0.2431|||||||Wilcoxon Signed Rank Test|||||||0.2431
71909740|NCT01769469|143340694|OTHER|||||||0.7209|||||||Wilcoxon Signed Rank Test|||||||0.7209
71909741|NCT01769469|143340695|OTHER|||||||0.5379|||||||Wilcoxon Signed Rank Test|||||||0.5379
71909742|NCT01769469|143340696|OTHER|||||||0.7986|||||||Wilcoxon Signed Rank Test|||||||0.7986
71909743|NCT01769469|143340716|OTHER|||||||0.8507|||||||Wilcoxon Signed Rank Test|||||||0.8507
71909744|NCT01769469|143340717|OTHER|||||||0.3483|||||||Wilcoxon Signed Rank Test|||||||0.3483
71909745|NCT01769469|143340724|OTHER|||||||0.4043|||||||Wilcoxon (Mann-Whitney)|||||||0.4043
71909746|NCT01769469|143340725|OTHER|||||||0.2927|||||||Wilcoxon (Mann-Whitney)|||||||0.2927
71909747|NCT01769469|143340726|OTHER|||||||0.1134|||||||Wilcoxon (Mann-Whitney)|||||||0.1134
71909748|NCT01769469|143340727|OTHER|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||||||0.5782
71909749|NCT01769469|143340728|OTHER|||||||0.8658|||||||Wilcoxon (Mann-Whitney)|||||||0.8658
71909750|NCT01769469|143340729|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
71909751|NCT01769469|143340730|OTHER|||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
71909752|NCT01769469|143340731|OTHER|||||||0.1172|||||||Wilcoxon (Mann-Whitney)|||||||0.1172
71909753|NCT01769469|143340732|OTHER|||||||0.122|||||||Wilcoxon (Mann-Whitney)|||||||0.1220
71909754|NCT01769469|143340733|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71909755|NCT01769469|143340735|OTHER|||||||0.7785|||||||Wilcoxon (Mann-Whitney)|||||||0.7785
71909756|NCT01769469|143340736|OTHER|||||||0.4933|||||||Wilcoxon (Mann-Whitney)|||||||0.4933
71909757|NCT01769469|143340737|OTHER|||||||0.5491|||||||Wilcoxon (Mann-Whitney)|||||||0.5491
71909758|NCT01769469|143340738|OTHER|||||||0.5161|||||||Wilcoxon (Mann-Whitney)|||||||0.5161
71909759|NCT01769469|143340739|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.5990
71909760|NCT01769469|143340740|OTHER|||||||0.8579|||||||Wilcoxon (Mann-Whitney)|||||||0.8579
71909761|NCT01769469|143340741|OTHER|||||||0.0719|||||||Wilcoxon (Mann-Whitney)|||||||0.0719
71909762|NCT01769469|143340742|OTHER|||||||0.3148|||||||Wilcoxon (Mann-Whitney)|||||||0.3148
71909763|NCT01769469|143340743|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.1390
71909764|NCT01769469|143340744|OTHER|||||||0.2726|||||||Wilcoxon (Mann-Whitney)|||||||0.2726
71681855|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.17||0.0007|TWO_SIDED|95.0|-0.914|-0.247|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.247|-0.914|0.0007
71681856|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.169||0.0391|TWO_SIDED|95.0|-0.683|-0.018|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use||-0.018|-0.683|0.0391
71681857|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.991|STANDARD_ERROR_OF_MEAN|0.269||0.0002|TWO_SIDED|95.0|-1.518|-0.464|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.464|-1.518|0.0002
71681858|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.902|STANDARD_ERROR_OF_MEAN|0.267||0.0008|TWO_SIDED|95.0|-1.426|-0.378|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||-0.378|-1.426|0.0008
71863479|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.07|||=|0.001|TWO_SIDED|95.0|0.028|0.112|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Day 1.||0.112|0.028|=0.001
71863480|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.038|0.122|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Day 1.||0.122|0.038|<0.001
71863481|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.065|||=|0.048|TWO_SIDED|95.0|0.001|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Week 4.||0.129|0.001|=0.048
71863482|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.119|||<|0.001|TWO_SIDED|95.0|0.055|0.183|||LS mean difference|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Week 4.||0.183|0.055|<0.001
71863483|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.085|||=|0.008|TWO_SIDED|95.0|0.022|0.149|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Week 4.||0.149|0.022|=0.008
71863484|NCT03443414|143241516|OTHER|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.072|||=|0.028|TWO_SIDED|95.0|0.008|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Week 4.||0.137|0.008|=0.028
71863485|NCT02103114|143241533|EQUIVALENCE|T1 (Baseline)||||||0.982|||||||t-test, 2 sided|||||||0.982
71863486|NCT02103114|143241533|EQUIVALENCE|T2 (30 minutes after study drug)|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71863487|NCT02103114|143241533|EQUIVALENCE|T3 (30 minutes on CPB)||||||0.001|||||||t-test, 2 sided|||||||0.001
71863488|NCT02103114|143241533|EQUIVALENCE|T5 (Arrival in ICU)||||||0.003|||||||t-test, 2 sided|||||||0.003
71863489|NCT02103114|143241533|EQUIVALENCE|T6 (POD 2)||||||0.84|||||||t-test, 2 sided|||||||0.840
71863490|NCT02103114|143241533|EQUIVALENCE|T7 (POD 4)||||||0.475|||||||t-test, 2 sided|||||||0.475
71909765|NCT01769469|143340745|OTHER|||||||0.537|||||||Wilcoxon (Mann-Whitney)|||||||0.5370
71909766|NCT01769469|143340746|OTHER|||||||0.2926|||||||Wilcoxon (Mann-Whitney)|||||||0.2926
71909767|NCT01769469|143340747|OTHER|||||||0.1906|||||||Wilcoxon (Mann-Whitney)|||||||0.1906
71909768|NCT01769469|143340748|OTHER|||||||0.2255|||||||Wilcoxon (Mann-Whitney)|||||||0.2255
71681859|NCT00793624|142881818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.473|STANDARD_ERROR_OF_MEAN|0.266||0.0758|TWO_SIDED|95.0|-0.994|0.049|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use||0.049|-0.994|0.0758
71863491|NCT02103114|143241534|EQUIVALENCE|T4 (just prior to coming off of CPB)||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
71863492|NCT02103114|143241535|EQUIVALENCE|T1 (Baseline)||||||0.855|||||||Wilcoxon (Mann-Whitney)|||||||0.855
71863493|NCT02103114|143241535|EQUIVALENCE|T5 (Arrival in ICU)||||||0.225|||||||Wilcoxon (Mann-Whitney)|||||||0.225
71863494|NCT02103114|143241535|EQUIVALENCE|T6 (POD 2)||||||0.313|||||||Wilcoxon (Mann-Whitney)|||||||0.313
71863495|NCT02103114|143241535|EQUIVALENCE|T7 (POD 4)||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71863496|NCT02103114|143241538|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.056|||||||Wilcoxon (Mann-Whitney)|||||||0.056
71863497|NCT02103114|143241539|EQUIVALENCE|T1 (Baseline) to T5 (Arrival in ICU)||||||0.545|||||||Wilcoxon (Mann-Whitney)|||||||0.545
71863498|NCT02103114|143241541|EQUIVALENCE|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||||0.757|||||||Wilcoxon (Mann-Whitney)|||||||0.757
71863499|NCT02103114|143241544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2741|||||||t-test, 2 sided|24 hour postop Fresh Frozen Plasma exposures||||||0.2741
71863500|NCT02103114|143241544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0351|||||||t-test, 2 sided|24 hour postop Platelet exposures||||||0.0351
71863501|NCT02103114|143241544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||t-test, 2 sided|24 hour postop Cryoprecipitate exposures||||||0.073
71863502|NCT02103114|143241544|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0196|||||||t-test, 2 sided|24 hour postop Red Blood Cell exposures||||||0.0196
71909769|NCT01769469|143340749|OTHER|||||||0.6285|||||||Wilcoxon (Mann-Whitney)|||||||0.6285
71909770|NCT01769469|143340750|OTHER|||||||0.0148|||||||Wilcoxon (Mann-Whitney)|||||||0.0148
71909771|NCT01769469|143340751|OTHER|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||||||0.0166
71909772|NCT01769469|143340752|OTHER|||||||0.0277|||||||Wilcoxon (Mann-Whitney)|||||||0.0277
71909773|NCT01769469|143340753|OTHER|||||||0.261|||||||Wilcoxon (Mann-Whitney)|||||||0.2610
71681860|NCT00793624|142881819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0003||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.2|-0.6|0.0003
71681861|NCT00793624|142881819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0073||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0073
71863503|NCT02103114|143241545|EQUIVALENCE|protamine time plus 24 hours||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71863504|NCT02103114|143241547|EQUIVALENCE|24 Hours Post-Operatively||||||0.0004|||||||Fisher Exact|||||||0.0004
71863505|NCT02103114|143241548|SUPERIORITY_OR_OTHER_LEGACY|||||||0.927|||||||t-test, 2 sided|||||||0.927
71863506|NCT02103114|143241549|SUPERIORITY_OR_OTHER_LEGACY|||||||0.738|||||||t-test, 2 sided|||||||0.738
71863507|NCT02103114|143241550|SUPERIORITY_OR_OTHER_LEGACY|||||||0.231|||||||Fisher Exact|||||||0.231
71863508|NCT02103114|143241551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.661|||||||Fisher Exact|||||||0.661
71863509|NCT02103114|143241553|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||||||1.0
71863510|NCT02103114|143241554|SUPERIORITY_OR_OTHER_LEGACY|||||||0.342|||||||Fisher Exact|||||||0.342
71863511|NCT02103114|143241555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.961|||||||t-test, 2 sided|||||||0.961
71863512|NCT03933462|143241556|SUPERIORITY|"Categorical preference endpoints that answered at the final visit (e.g., Which device do you prefer?) were analyzed with a One-sample Binomial Test that compared the observed proportion to a 50/50 split."|||||<|0.001|||||||One Sample Binomial|||||||<0.001
71863513|NCT04692467|143241565|SUPERIORITY||Mean Difference (Final Values)|-5.88|||<|0.0001|TWO_SIDED|95.0|-8.77|-3.01|||Mixed Models Analysis||The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).|||-3.01|-8.77|<0.0001
71863514|NCT00422734|143241584|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
71863515|NCT00422734|143241585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
71863516|NCT00422734|143241585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
71863517|NCT00422734|143241586|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863518|NCT00422734|143241587|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863519|NCT00422734|143241588|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for subject scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71863520|NCT00422734|143241588|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for partner scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71863521|NCT00422734|143241589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
71863522|NCT00422734|143241589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.||||<0.001
71863523|NCT00422734|143241590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 4|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863524|NCT00422734|143241590|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for SEP Question 5|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863525|NCT00422734|143241591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863526|NCT00422734|143241592|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863527|NCT00422734|143241593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71863528|NCT00422734|143241593|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71863529|NCT00422734|143241594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71863530|NCT00422734|143241594|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p\<0.10||||||<0.001
71863531|NCT00422734|143241595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 1|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863532|NCT00422734|143241595|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEP Question 2|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863533|NCT00422734|143241596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Total Score|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863534|NCT00422734|143241596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Sexual Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863535|NCT00422734|143241596|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Confidence|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863536|NCT00422734|143241597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Self-Esteem|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863537|NCT00422734|143241597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is for SEAR Overall Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p\<0.10.||||||<0.001
71863538|NCT02078492|143241609|NON_INFERIORITY_OR_EQUIVALENCE|We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.||||||0.783|||||||ANOVA|2 degrees of freedom||The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.||||.783
71863539|NCT03041792|143241618|SUPERIORITY||Least Square Mean Difference|-235.75|STANDARD_ERROR_OF_MEAN|43.13||0|TWO_SIDED|95.0|-322.25|-149.25||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-149.25|-322.25|0.0000
71863540|NCT03041792|143241618|SUPERIORITY||Least Square Mean Difference|-243.63|STANDARD_ERROR_OF_MEAN|47.6||0|TWO_SIDED|95.0|-339.1|-148.15||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-148.15|-339.10|0.0000
71863541|NCT03041792|143241623|SUPERIORITY||Least Square Mean Difference|-859.58|STANDARD_ERROR_OF_MEAN|167.76||0|TWO_SIDED|95.0|-1196.1|-523.1||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 4||-523.10|-1196.1|0.0000
71863542|NCT03041792|143241623|SUPERIORITY||Least Square Mean Difference|-928.56|STANDARD_ERROR_OF_MEAN|193.8||0|TWO_SIDED|95.0|-1317.3|-539.86||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of \<0.05.|Mixed Models Analysis|||Visit 5||-539.86|-1317.3|0.0000
71863543|NCT03041792|143241624|SUPERIORITY||Least Square Mean Difference|4.95|STANDARD_ERROR_OF_MEAN|2.16||0.0263|TWO_SIDED|95.0|0.61|9.29|||Mixed Models Analysis|||Visit 4||9.29|0.61|0.0263
71863544|NCT03041792|143241624|SUPERIORITY||Least Square Mean Difference|5.35|STANDARD_ERROR_OF_MEAN|2.06||0.0121|TWO_SIDED|95.0|1.22|9.48|||Mixed Models Analysis|||Visit 5||9.48|1.22|0.0121
71681862|NCT00793624|142881819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0017||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0017
71681863|NCT00793624|142881820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0021||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0021
71863545|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|3.98|STANDARD_ERROR_OF_MEAN|2.91||0.1768|TWO_SIDED|95.0|-1.85|9.82|||Mixed Models Analysis|||Satiety (Visit 4)||9.82|-1.85|0.1768
71863546|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|2.13||0.1137|TWO_SIDED|95.0|-0.85|7.7|||Mixed Models Analysis|||Satiety (Visit 5)||7.70|-0.85|0.1137
71863547|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|2.12||0.1858|TWO_SIDED|95.0|-1.41|7.11|||Mixed Models Analysis|||Fullness (Visit 4)||7.11|-1.41|0.1858
71863548|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|1.41|STANDARD_ERROR_OF_MEAN|2.22||0.5288|TWO_SIDED|95.0|-3.05|5.86|||Mixed Models Analysis|||Fullness (Visit 5)||5.86|-3.05|0.5288
71863549|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|-8.46|STANDARD_ERROR_OF_MEAN|2.91||0.0054|TWO_SIDED|95.0|-14.3|-2.61|||Mixed Models Analysis|||Prospective food consumption (Visit 4)||-2.61|-14.30|0.0054
71863550|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|-9.78|STANDARD_ERROR_OF_MEAN|3.75||0.0117|TWO_SIDED|95.0|-17.29|-2.27|||Mixed Models Analysis|||Prospective food consumption (Visit 5)||-2.27|-17.29|0.0117
71863551|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|-6.58|STANDARD_ERROR_OF_MEAN|2.44||0.0093|TWO_SIDED|95.0|-11.48|-1.69|||Mixed Models Analysis|||Hunger (Visit 4)||-1.69|-11.48|0.0093
71863552|NCT03041792|143241625|SUPERIORITY||Least Square Mean Difference|-6.39|STANDARD_ERROR_OF_MEAN|2.86||0.0296|TWO_SIDED|95.0|-12.12|-0.66|||Mixed Models Analysis|||Hunger (Visit 5)||-0.66|-12.12|0.0296
71863553|NCT03041792|143241626|SUPERIORITY||Least Square Mean Difference|35.56|STANDARD_ERROR_OF_MEAN|52.46||0.5008|TWO_SIDED|95.0|-69.64|140.76|||Mixed Models Analysis|||AUC0-60min (Visit 4)||140.76|-69.64|0.5008
71863554|NCT03041792|143241626|SUPERIORITY||Least Square Mean Difference|106.15|STANDARD_ERROR_OF_MEAN|48.95||0.0348|TWO_SIDED|95.0|7.86|204.44|||Mixed Models Analysis|||AUC0-60min (Visit 5)||204.44|7.86|0.0348
71863555|NCT03041792|143241626|SUPERIORITY||Least Square Mean Difference|214.24|STANDARD_ERROR_OF_MEAN|129.48||0.104|TWO_SIDED|95.0|-45.59|474.07|||Mixed Models Analysis|||AUC0-300min (Visit 4)||474.07|-45.59|0.1040
71863556|NCT03041792|143241626|SUPERIORITY||Least Square Mean Difference|348.43|STANDARD_ERROR_OF_MEAN|138.29||0.0152|TWO_SIDED|95.0|70.2|626.66|||Mixed Models Analysis|||AUC0-300min (Visit 5)||626.66|70.20|0.0152
71863557|NCT00305344|143241737|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Fisher Exact|||Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion||||>0.05
71863558|NCT02209181|143241758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.38|STANDARD_ERROR_OF_MEAN|2.522|<|0.001|TWO_SIDED|95.0|11.42|21.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.35|11.42|<0.001
71863559|NCT02209181|143241758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|2.503||0.068|TWO_SIDED|95.0|-0.35|9.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||9.51|-0.35|0.068
71863560|NCT02209181|143241758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.2|STANDARD_ERROR_OF_MEAN|2.531|<|0.001|TWO_SIDED|95.0|11.21|21.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.18|11.21|<0.001
71863561|NCT02209181|143241758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.81|STANDARD_ERROR_OF_MEAN|2.503|<|0.001|TWO_SIDED|95.0|-16.73|-6.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-6.88|-16.73|<0.001
71863562|NCT02209181|143241758|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|2.531||0.941|TWO_SIDED|95.0|-5.17|4.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.80|-5.17|0.941
71863563|NCT02209181|143241759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.15||0.448|TWO_SIDED|95.0|-0.19|0.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.42|-0.19|0.448
71863564|NCT02209181|143241759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.15||0.618|TWO_SIDED|95.0|-0.38|0.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.22|-0.38|0.618
71863565|NCT02209181|143241759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.15||0.621|TWO_SIDED|95.0|-0.23|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.23|0.621
71863566|NCT02209181|143241759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.207|TWO_SIDED|95.0|-0.49|0.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.11|-0.49|0.207
71909774|NCT01769469|143340754|OTHER|||||||0.4154|||||||Wilcoxon (Mann-Whitney)|||||||0.4154
71909775|NCT01769469|143340755|OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||||||0.7125
71681864|NCT00793624|142881820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.2|-0.6|<0.0001
71681865|NCT00793624|142881820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0121||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||-0.1|-0.5|0.0121
71681866|NCT00793624|142881821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.032||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||-0.0|-0.4|0.0320
71681867|NCT00793624|142881821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0447||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||-0.0|-0.4|0.0447
71681868|NCT00793624|142881821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1332||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1332
71863567|NCT02209181|143241759|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.15||0.794|TWO_SIDED|95.0|-0.34|0.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.26|-0.34|0.794
71909776|NCT01617187|143340813|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) means difference|-1.3|STANDARD_ERROR_OF_MEAN|2.46||0.6043|TWO_SIDED|95.0|-6.1|3.6||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|Mixed Model Repeated Measures (MMRM)||Asenapine 2.5 mg BID minus Placebo BID|||3.6|-6.1|0.6043
71863568|NCT02209181|143241760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|0.82|1.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.86|0.82|<0.001
71863569|NCT02209181|143241760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.26||0.42|TWO_SIDED|95.0|-0.3|0.72||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.72|-0.30|0.420
71863570|NCT02209181|143241760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.083|TWO_SIDED|95.0|-0.06|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.06|0.083
71863571|NCT02209181|143241760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.64|-0.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.62|-1.64|<0.001
71863572|NCT02209181|143241760|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.4|-0.37||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.37|-1.40|<0.001
71909777|NCT01617187|143340813|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.5|STANDARD_ERROR_OF_MEAN|2.32||0.0356|TWO_SIDED|95.0|-10.1|-1.0||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID|||-1.0|-10.1|0.0356
71909778|NCT01617187|143340813|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-5.4|STANDARD_ERROR_OF_MEAN|2.86||0.0587|TWO_SIDED|95.0|-11.1|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-11.1|0.0587
71863573|NCT02209181|143241761|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.93|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|2.28|3.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.59|2.28|<0.001
71863574|NCT02209181|143241761|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.33||0.058|TWO_SIDED|95.0|-0.02|1.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.29|-0.02|0.058
71863575|NCT02209181|143241761|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.23|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|0.57|1.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.89|0.57|<0.001
71863576|NCT02209181|143241761|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-2.96|-1.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.65|-2.96|<0.001
71863577|NCT02209181|143241761|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.71|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.37|-1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.04|-2.37|<0.001
71863578|NCT02209181|143241762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|3.01|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|3.01|<0.001
71863579|NCT02209181|143241762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|0.36||0.035|TWO_SIDED|95.0|0.06|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|0.06|0.035
71909779|NCT01617187|143340814|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.9083|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.3|-0.3|0.9083
71909780|NCT01617187|143340814|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0601|TWO_SIDED|95.0|-0.6|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||0.0|-0.6|0.0601
71909781|NCT01617187|143340814|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3898|TWO_SIDED|95.0|-0.5|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||0.2|-0.5|0.3898
71909782|NCT01617187|143340815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.3700
71909783|NCT01617187|143340815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1708||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)||||0.1708
71909784|NCT01617187|143340815|SUPERIORITY_OR_OTHER_LEGACY|||||||0.262||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||||||0.2620
71909785|NCT01617187|143340816|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.6||0.0491|TWO_SIDED|95.0|-2.4|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 2.5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.4|0.0491
71909786|NCT01617187|143340816|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.57||0.0491|TWO_SIDED|95.0|-2.3|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 5 mg BID minus Olanzapine 15 mg QD|||-0.0|-2.3|0.0491
71909787|NCT01617187|143340816|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.51||0.0567|TWO_SIDED|95.0|0.0|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|||2.0|-0.0|0.0567
71909788|NCT01617187|143340816|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.48||0.0391|TWO_SIDED|95.0|0.0|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|||1.9|0.0|0.0391
71909789|NCT01617187|143340816|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|2.2|STANDARD_ERROR_OF_MEAN|0.58||0.0003|TWO_SIDED|95.0|1.0|3.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|||3.3|1.0|0.0003
71909790|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.8|STANDARD_ERROR_OF_MEAN|1.09||0.4849|TWO_SIDED|95.0|-1.4|2.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||2.9|-1.4|0.4849
71909791|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.06||0.8902|TWO_SIDED|95.0|-2.2|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.9|-2.2|0.8902
71909792|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.36||0.5826|TWO_SIDED|95.0|-3.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.9|-3.4|0.5826
71909793|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|1.61||0.9271|TWO_SIDED|95.0|-3.3|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||3.0|-3.3|0.9271
71909794|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|1.56||0.1902|TWO_SIDED|95.0|-5.1|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||1.0|-5.1|0.1902
71909795|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|2.0||0.271|TWO_SIDED|95.0|-6.2|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.7|-6.2|0.2710
71909796|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.79||0.6773|TWO_SIDED|95.0|-2.8|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||4.3|-2.8|0.6773
71909797|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|1.72||0.2895|TWO_SIDED|95.0|-5.2|1.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.6|-5.2|0.2895
71909798|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.7|STANDARD_ERROR_OF_MEAN|2.18||0.4261|TWO_SIDED|95.0|-6.0|2.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||2.6|-6.0|0.4261
71909799|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.3|STANDARD_ERROR_OF_MEAN|2.13||0.5505|TWO_SIDED|95.0|-2.9|5.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||5.5|-2.9|0.5505
71909800|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.03||0.4286|TWO_SIDED|95.0|-5.6|2.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||2.4|-5.6|0.4286
71909801|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|2.56||0.4423|TWO_SIDED|95.0|-7.0|3.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||3.1|-7.0|0.4423
71909802|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|3.2|STANDARD_ERROR_OF_MEAN|2.3||0.1691|TWO_SIDED|95.0|-1.4|7.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||7.7|-1.4|0.1691
71909803|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.17||0.4682|TWO_SIDED|95.0|-5.8|2.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||2.7|-5.8|0.4682
71909804|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|2.71||0.4961|TWO_SIDED|95.0|-7.2|3.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||3.5|-7.2|0.4961
71909805|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|2.26||0.4697|TWO_SIDED|95.0|-6.1|2.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||2.8|-6.1|0.4697
71863580|NCT02209181|143241762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.94|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|1.21|2.67||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.67|1.21|<0.001
71863581|NCT02209181|143241762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-3.68|-2.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.24|-3.68|<0.001
71863582|NCT02209181|143241762|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.52|-1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.07|-2.52|<0.001
71863583|NCT02209181|143241763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.99|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|3.21|4.77||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.77|3.21|<0.001
71863584|NCT02209181|143241763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.39||0.028|TWO_SIDED|95.0|0.09|1.64||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.64|0.09|0.028
71863585|NCT02209181|143241763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.48|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|1.7|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|1.70|<0.001
71863586|NCT02209181|143241763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.12|STANDARD_ERROR_OF_MEAN|0.39|<|0.001|TWO_SIDED|95.0|-3.9|-2.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.35|-3.90|<0.001
71863587|NCT02209181|143241763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.51|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.29|-0.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.73|-2.29|<0.001
71863588|NCT02209181|143241764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.92|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.92|<0.001
71863589|NCT02209181|143241764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.02|STANDARD_ERROR_OF_MEAN|0.44||0.021|TWO_SIDED|95.0|0.16|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|0.16|0.021
71863590|NCT02209181|143241764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.06|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|2.19|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|2.19|<0.001
71863591|NCT02209181|143241764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED|95.0|-3.63|-1.91||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.91|-3.63|<0.001
71863592|NCT02209181|143241764|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.44||0.104|TWO_SIDED|95.0|-1.59|0.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.15|-1.59|0.104
71863593|NCT02209181|143241765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.18|4.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.07|2.18|<0.001
71863594|NCT02209181|143241765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.98|STANDARD_ERROR_OF_MEAN|0.48||0.041|TWO_SIDED|95.0|0.04|1.92||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.92|0.04|0.041
71863595|NCT02209181|143241765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.14|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|2.19|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|2.19|<0.001
71863596|NCT02209181|143241765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.15|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-3.09|-1.21||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.21|-3.09|<0.001
71863597|NCT02209181|143241765|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.48||0.973|TWO_SIDED|95.0|-0.93|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-0.93|0.973
71863598|NCT02209181|143241766|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.87|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.87|3.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.87|1.87|<0.001
71863599|NCT02209181|143241766|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|0.5||0.079|TWO_SIDED|95.0|-0.1|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.88|-0.10|0.079
71863600|NCT02209181|143241766|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|2.27|4.27||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.27|2.27|<0.001
71863601|NCT02209181|143241766|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.98|-1.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.00|-2.98|<0.001
71863602|NCT02209181|143241766|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.51||0.44|TWO_SIDED|95.0|-0.61|1.4||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.40|-0.61|0.440
71863603|NCT02209181|143241767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.52|3.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.57|1.52|<0.001
71863604|NCT02209181|143241767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.118|TWO_SIDED|95.0|-0.21|1.83||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.83|-0.21|0.118
71863605|NCT02209181|143241767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.13|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|2.1|4.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.16|2.10|<0.001
71863606|NCT02209181|143241767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.73|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|-2.75|-0.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.71|-2.75|<0.001
71863607|NCT02209181|143241767|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.262|TWO_SIDED|95.0|-0.44|1.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.62|-0.44|0.262
71863608|NCT02209181|143241768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.92|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|0.88|2.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.96|0.88|<0.001
71863609|NCT02209181|143241768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.58|STANDARD_ERROR_OF_MEAN|0.52||0.271|TWO_SIDED|95.0|-0.45|1.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.61|-0.45|0.271
71863610|NCT02209181|143241768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.95|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.91|3.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.99|1.91|<0.001
71863611|NCT02209181|143241768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.52||0.011|TWO_SIDED|95.0|-2.37|-0.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.32|-2.37|0.011
71863612|NCT02209181|143241768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.03|STANDARD_ERROR_OF_MEAN|0.53||0.052|TWO_SIDED|95.0|-0.01|2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.07|-0.01|0.052
71863613|NCT02209181|143241769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|0.21|2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.29|0.21|0.018
71863614|NCT02209181|143241769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.52||0.31|TWO_SIDED|95.0|-0.5|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.50|0.310
71863615|NCT02209181|143241769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.8|STANDARD_ERROR_OF_MEAN|0.53|<|0.001|TWO_SIDED|95.0|1.76|3.85||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.85|1.76|<0.001
71863616|NCT02209181|143241769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.52||0.172|TWO_SIDED|95.0|-1.75|0.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.31|-1.75|0.172
71863617|NCT02209181|143241769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.55|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|0.51|2.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.60|0.51|0.004
71863618|NCT02209181|143241770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.84|STANDARD_ERROR_OF_MEAN|0.51||0.102|TWO_SIDED|95.0|-0.17|1.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.84|-0.17|0.102
71863619|NCT02209181|143241770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.51||0.479|TWO_SIDED|95.0|-0.64|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.64|0.479
71863620|NCT02209181|143241770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.85|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.85|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.85|<0.001
71863621|NCT02209181|143241770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.51||0.345|TWO_SIDED|95.0|-1.47|0.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.52|-1.47|0.345
71863622|NCT02209181|143241770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.01|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.01|3.02||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.02|1.01|<0.001
71863623|NCT02209181|143241771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.338|TWO_SIDED|95.0|-0.52|1.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.51|-0.52|0.338
71863624|NCT02209181|143241771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.51||0.299|TWO_SIDED|95.0|-0.47|1.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.54|-0.47|0.299
71863625|NCT02209181|143241771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.72|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.7|3.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.73|1.70|<0.001
71863626|NCT02209181|143241771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.51||0.942|TWO_SIDED|95.0|-0.97|1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.04|-0.97|0.942
71863627|NCT02209181|143241771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.22|STANDARD_ERROR_OF_MEAN|0.52|<|0.001|TWO_SIDED|95.0|1.21|3.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.24|1.21|<0.001
71863628|NCT02209181|143241772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.51||0.306|TWO_SIDED|95.0|-0.48|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.48|0.306
71863629|NCT02209181|143241772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.51||0.335|TWO_SIDED|95.0|-0.51|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.49|-0.51|0.335
71863630|NCT02209181|143241772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.78|3.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.80|1.78|<0.001
71863631|NCT02209181|143241772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.51||0.946|TWO_SIDED|95.0|-1.03|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.97|-1.03|0.946
71863632|NCT02209181|143241772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.27|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.25|3.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.28|1.25|<0.001
71863633|NCT02209181|143241773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.51||0.279|TWO_SIDED|95.0|-0.45|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.56|-0.45|0.279
71863634|NCT02209181|143241773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.54|STANDARD_ERROR_OF_MEAN|0.51||0.292|TWO_SIDED|95.0|-0.46|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.53|-0.46|0.292
71863635|NCT02209181|143241773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.66|3.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.68|1.66|<0.001
71863636|NCT02209181|143241773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.51||0.971|TWO_SIDED|95.0|-1.02|0.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.98|-1.02|0.971
71909806|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-3.6|STANDARD_ERROR_OF_MEAN|2.14||0.0947|TWO_SIDED|95.0|-7.8|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.6|-7.8|0.0947
71909807|NCT01617187|143340817|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-4.9|STANDARD_ERROR_OF_MEAN|2.68||0.0675|TWO_SIDED|95.0|-10.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.4|-10.2|0.0675
71909808|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
71909809|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1736||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.1736
71909810|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.285||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.2850
71909811|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.3290
71863637|NCT02209181|143241773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.11|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.11|3.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.12|1.11|<0.001
71863638|NCT02209181|143241774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.329|TWO_SIDED|95.0|-0.5|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-0.50|0.329
71863639|NCT02209181|143241774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.32|STANDARD_ERROR_OF_MEAN|0.5||0.531|TWO_SIDED|95.0|-0.68|1.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.31|-0.68|0.531
71863640|NCT02209181|143241774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.53|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.53|3.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.54|1.53|<0.001
71863641|NCT02209181|143241774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.5||0.722|TWO_SIDED|95.0|-1.17|0.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.81|-1.17|0.722
71909812|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6938||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.6938
71909813|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1105||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1105
71909814|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6804||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6804
71909815|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9704||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.9704
71909816|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6604||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.6604
71909817|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2447||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.2447
71909818|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4834||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4834
71909819|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9189||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.9189
71909820|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.437||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.4370
71909821|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2894||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.2894
71909822|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6953||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.6953
71909823|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4892||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.4892
71909824|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1954||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.1954
71909825|NCT01617187|143340818|SUPERIORITY_OR_OTHER_LEGACY|||||||0.799||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.7990
71909826|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.07||0.4255|TWO_SIDED|95.0|-0.1|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.2|-0.1|0.4255
71909827|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9564|TWO_SIDED|95.0|-0.1|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.1|-0.1|0.9564
71909828|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.08||0.6363|TWO_SIDED|95.0|-0.2|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.1|-0.2|0.6363
71909829|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8759|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.8759
71909830|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.9598|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9598
71909831|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.9789|TWO_SIDED|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-0.2|0.9789
71909832|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.4671|TWO_SIDED|95.0|-0.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.1|-0.3|0.4671
71909833|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.6359|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.2|-0.3|0.6359
71909834|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.14||0.5454|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.2|-0.4|0.5454
71909835|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.13||0.4188|TWO_SIDED|95.0|-0.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.4|-0.2|0.4188
71909836|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.5318|TWO_SIDED|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.2|-0.3|0.5318
71909837|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.5683|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.2|-0.4|0.5683
71909838|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2972|TWO_SIDED|95.0|-0.1|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||0.4|-0.1|0.2972
71909839|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.482|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.2|-0.4|0.4820
71909840|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.9901|TWO_SIDED|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.3|-0.3|0.9901
71909841|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.6682|TWO_SIDED|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.2|-0.4|0.6682
71909842|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1111|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.1111
71909843|NCT01617187|143340819|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.24|TWO_SIDED|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.1|-0.5|0.2400
71909844|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6205||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.6205
71909845|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4829||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.4829
71909846|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3945||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4||||0.3945
71909847|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4076||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.4076
71909848|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.969||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.9690
71909849|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.117||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7||||0.1170
71909850|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5088||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.5088
71909851|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3426||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.3426
71909852|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0762||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14||||0.0762
71909853|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5531||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.5531
71909854|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4875||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.4875
71909855|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0692||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21||||0.0692
71909856|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7482||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.7482
71909857|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8037||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.8037
71909858|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0859||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28||||0.0859
71909859|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.585||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.5850
71909860|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9698||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.9698
71909861|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0132||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35||||0.0132
71909862|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7129||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.7129
71909863|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5074||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.5074
71909864|NCT01617187|143340820|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42||||0.0040
71909865|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.4||0.8829|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.8829
71909866|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.39||0.5488|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5488
71909867|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.783|TWO_SIDED|95.0|-1.1|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.1|0.7830
71909868|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.45||0.807|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.8|-1.0|0.8070
71909869|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.44||0.528|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5280
71909870|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.57||0.4025|TWO_SIDED|95.0|-1.6|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.6|0.4025
71909871|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6471|TWO_SIDED|95.0|-0.8|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.2|-0.8|0.6471
71909872|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2504|TWO_SIDED|95.0|-1.5|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.5|0.2504
71909873|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.9223|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.9223
71909874|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8839|TWO_SIDED|95.0|-1.0|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-1.0|0.8839
71909875|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8077|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.2|0.8077
71909876|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.68||0.6216|TWO_SIDED|95.0|-1.0|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-1.0|0.6216
71909877|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.61||0.4248|TWO_SIDED|95.0|-0.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.7|-0.7|0.4248
71909878|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.7667|TWO_SIDED|95.0|-1.3|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.3|0.7667
71909879|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.72||0.6282|TWO_SIDED|95.0|-1.1|1.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.8|-1.1|0.6282
71909880|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.315|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.6|-1.9|0.3150
71909881|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.61||0.1908|TWO_SIDED|95.0|-2.0|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-2.0|0.1908
71909882|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.77||0.3128|TWO_SIDED|95.0|-2.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.7|-2.3|0.3128
71909883|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8812|TWO_SIDED|95.0|-1.5|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.3|-1.5|0.8812
71909884|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.69||0.1143|TWO_SIDED|95.0|-2.4|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-2.4|0.1143
71909885|NCT01617187|143340821|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.84||0.4418|TWO_SIDED|95.0|-2.3|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.0|-2.3|0.4418
71909886|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.4||0.216|TWO_SIDED|95.0|-0.3|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.3|-0.3|0.2160
71909887|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.39||0.9494|TWO_SIDED|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.7|0.9494
71909888|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.5||0.1834|TWO_SIDED|95.0|-1.6|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.3|-1.6|0.1834
71909889|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.53||0.6347|TWO_SIDED|95.0|-0.8|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.3|-0.8|0.6347
71909890|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.6917|TWO_SIDED|95.0|-1.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.8|-1.2|0.6917
71909891|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.66||0.1431|TWO_SIDED|95.0|-2.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.3|-2.3|0.1431
71909892|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.61||0.6267|TWO_SIDED|95.0|-0.9|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-0.9|0.6267
71909893|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.58||0.726|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-1.3|0.7260
71909894|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.74||0.3326|TWO_SIDED|95.0|-2.2|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-2.2|0.3326
71909895|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.5|STANDARD_ERROR_OF_MEAN|0.72||0.4575|TWO_SIDED|95.0|-0.9|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.9|-0.9|0.4575
71909896|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.493|TWO_SIDED|95.0|-1.8|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-1.8|0.4930
71681869|NCT00793624|142881822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.4105||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo|||0.1|-0.3|0.4105
71909897|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.86||0.1886|TWO_SIDED|95.0|-2.8|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.6|-2.8|0.1886
71909898|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.8||0.2643|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2643
71909899|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.76||0.3516|TWO_SIDED|95.0|-2.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.8|-2.2|0.3516
71909900|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|0.94||0.2068|TWO_SIDED|95.0|-3.1|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.7|-3.1|0.2068
71909901|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.82||0.7284|TWO_SIDED|95.0|-1.3|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.9|-1.3|0.7284
71909902|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.77||0.2698|TWO_SIDED|95.0|-2.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-2.4|0.2698
71909903|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.96||0.151|TWO_SIDED|95.0|-3.3|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-3.3|0.1510
71909904|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.88||0.8039|TWO_SIDED|95.0|-2.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.5|-2.0|0.8039
71909905|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.8|STANDARD_ERROR_OF_MEAN|0.83||0.0306|TWO_SIDED|95.0|-3.5|-0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.2|-3.5|0.0306
71909906|NCT01617187|143340822|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.1|STANDARD_ERROR_OF_MEAN|1.03||0.0406|TWO_SIDED|95.0|-4.1|-0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.1|-4.1|0.0406
71909907|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.66||0.7819|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-1.1|0.7819
71909908|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.703|TWO_SIDED|95.0|-1.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-1.5|0.7030
71909909|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.83||0.952|TWO_SIDED|95.0|-1.7|1.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.6|-1.7|0.9520
71681870|NCT00793624|142881822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0584||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo|||0.0|-0.4|0.0584
71681871|NCT00793624|142881822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1006||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo|||0.0|-0.4|0.1006
71909910|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.95||0.7907|TWO_SIDED|95.0|-2.1|1.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.6|-2.1|0.7907
71909911|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.91||0.1391|TWO_SIDED|95.0|-3.1|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-3.1|0.1391
71909912|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.18||0.4901|TWO_SIDED|95.0|-3.1|1.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.5|-3.1|0.4901
71909913|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|1.0||0.8079|TWO_SIDED|95.0|-1.7|2.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||2.2|-1.7|0.8079
71909914|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.95||0.3889|TWO_SIDED|95.0|-2.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.1|-2.7|0.3889
71909915|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.21||0.3907|TWO_SIDED|95.0|-3.4|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-3.4|0.3907
71909916|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|1.15||0.5363|TWO_SIDED|95.0|-1.5|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||3.0|-1.5|0.5363
71909917|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|1.09||0.5075|TWO_SIDED|95.0|-2.9|1.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.4|-2.9|0.5075
71909918|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.38||0.4526|TWO_SIDED|95.0|-3.7|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.7|-3.7|0.4526
71909919|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.8|STANDARD_ERROR_OF_MEAN|1.26||0.1548|TWO_SIDED|95.0|-0.7|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||4.3|-0.7|0.1548
71909920|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|1.19||0.6589|TWO_SIDED|95.0|-2.9|1.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.8|-2.9|0.6589
71909921|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|1.48||0.5171|TWO_SIDED|95.0|-3.9|2.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||2.0|-3.9|0.5171
71909922|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.2|STANDARD_ERROR_OF_MEAN|1.2||0.3133|TWO_SIDED|95.0|-3.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.2|-3.6|0.3133
71909923|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.13||0.1723|TWO_SIDED|95.0|-3.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.7|-3.8|0.1723
71681872|NCT00793624|142881823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.571|STANDARD_ERROR_OF_MEAN|0.335||0.0882||95.0|-0.085|1.227|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.227|-0.085|0.0882
71909924|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.6|STANDARD_ERROR_OF_MEAN|1.42||0.0663|TWO_SIDED|95.0|-5.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.2|-5.4|0.0663
71909925|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|1.32||0.5128|TWO_SIDED|95.0|-3.5|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.7|-3.5|0.5128
71909926|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.2|STANDARD_ERROR_OF_MEAN|1.24||0.0842|TWO_SIDED|95.0|-4.6|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-4.6|0.0842
71909927|NCT01617187|143340823|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.4|STANDARD_ERROR_OF_MEAN|1.52||0.1217|TWO_SIDED|95.0|-5.4|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.6|-5.4|0.1217
71909928|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.7|STANDARD_ERROR_OF_MEAN|0.39||0.0584|TWO_SIDED|95.0|0.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.5|-0.0|0.0584
71909929|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5197|TWO_SIDED|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||1.0|-0.5|0.5197
71909930|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.49||0.9693|TWO_SIDED|95.0|-0.9|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||1.0|-0.9|0.9693
71909931|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.56||0.6161|TWO_SIDED|95.0|-0.8|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.4|-0.8|0.6161
71909932|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.54||0.788|TWO_SIDED|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-1.2|0.7880
71909933|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.5526|TWO_SIDED|95.0|-1.8|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||1.0|-1.8|0.5526
71909934|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.67||0.7647|TWO_SIDED|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.5|-1.1|0.7647
71909935|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.64||0.89|TWO_SIDED|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||1.3|-1.2|0.8900
71681873|NCT00793624|142881823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.664|STANDARD_ERROR_OF_MEAN|0.336||0.0484||95.0|0.005|1.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.324|0.005|0.0484
71863642|NCT02209181|143241774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.001|TWO_SIDED|95.0|1.03|3.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.04|1.03|<0.001
71863643|NCT02209181|143241775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.5||0.38|TWO_SIDED|95.0|-0.54|1.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.42|-0.54|0.380
71863644|NCT02209181|143241775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.49||0.767|TWO_SIDED|95.0|-0.83|1.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.12|-0.83|0.767
71863645|NCT02209181|143241775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.52|3.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.49|1.52|<0.001
71863646|NCT02209181|143241775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.49||0.557|TWO_SIDED|95.0|-1.27|0.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.68|-1.27|0.557
71863647|NCT02209181|143241775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.08|3.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.05|1.08|<0.001
71863648|NCT02209181|143241776|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.55||0.64|TWO_SIDED|95.0|-0.83|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.35|-0.83|0.640
71863649|NCT02209181|143241776|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.55||0.798|TWO_SIDED|95.0|-0.94|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-0.94|0.798
71863650|NCT02209181|143241776|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.32|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|1.23|3.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.42|1.23|<0.001
71863651|NCT02209181|143241776|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.55||0.829|TWO_SIDED|95.0|-1.2|0.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-1.20|0.829
71863652|NCT02209181|143241776|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.06|STANDARD_ERROR_OF_MEAN|0.55|<|0.001|TWO_SIDED|95.0|0.97|3.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.16|0.97|<0.001
71863653|NCT02209181|143241777|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.16||0.117|TWO_SIDED|95.0|-0.06|0.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.57|-0.06|0.117
71681874|NCT00793624|142881823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.758|STANDARD_ERROR_OF_MEAN|0.338||0.0252||95.0|0.094|1.421|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.421|0.094|0.0252
71863654|NCT02209181|143241777|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.687|TWO_SIDED|95.0|-0.25|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.38|-0.25|0.687
71863655|NCT02209181|143241777|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.16||0.497|TWO_SIDED|95.0|-0.21|0.43||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.43|-0.21|0.497
71863656|NCT02209181|143241777|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.239|TWO_SIDED|95.0|-0.51|0.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.13|-0.51|0.239
71863657|NCT02209181|143241777|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.16||0.376|TWO_SIDED|95.0|-0.46|0.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.18|-0.46|0.376
71863658|NCT02209181|143241778|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.78|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|1.14|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|1.14|<0.001
71863659|NCT02209181|143241778|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.32||0.35|TWO_SIDED|95.0|-0.33|0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.94|-0.33|0.350
71863660|NCT02209181|143241778|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.183|TWO_SIDED|95.0|-0.21|1.08||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.08|-0.21|0.183
71863661|NCT02209181|143241778|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.11|-0.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.84|-2.11|<0.001
71863662|NCT02209181|143241778|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.98|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.70|-1.98|<0.001
71863663|NCT02209181|143241779|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.78|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|2.94|4.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.61|2.94|<0.001
71863664|NCT02209181|143241779|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.42||0.037|TWO_SIDED|95.0|0.05|1.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.71|0.05|0.037
71863665|NCT02209181|143241779|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.47|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.63|2.3||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.30|0.63|<0.001
71863666|NCT02209181|143241779|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-3.73|-2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.07|-3.73|<0.001
71863667|NCT02209181|143241779|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|-3.15|-1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.47|-3.15|<0.001
71863668|NCT02209181|143241780|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|3.43|5.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.25|3.43|<0.001
71863669|NCT02209181|143241780|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.46||0.067|TWO_SIDED|95.0|-0.06|1.75||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.75|-0.06|0.067
71863670|NCT02209181|143241780|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.26|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|1.34|3.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.17|1.34|<0.001
71909936|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.81||0.7097|TWO_SIDED|95.0|-1.9|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.3|-1.9|0.7097
71863671|NCT02209181|143241780|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.49|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-4.4|-2.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.59|-4.40|<0.001
71909937|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.76||0.4601|TWO_SIDED|95.0|-0.9|2.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||2.1|-0.9|0.4601
71909938|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.72||0.6288|TWO_SIDED|95.0|-1.8|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.1|-1.8|0.6288
71909939|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.91||0.6099|TWO_SIDED|95.0|-2.3|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.3|-2.3|0.6099
71909940|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.9|STANDARD_ERROR_OF_MEAN|0.82||0.279|TWO_SIDED|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.5|-0.7|0.2790
71909941|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.77||0.4253|TWO_SIDED|95.0|-2.1|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.9|-2.1|0.4253
71909942|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.0|STANDARD_ERROR_OF_MEAN|0.96||0.3014|TWO_SIDED|95.0|-2.9|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.9|-2.9|0.3014
71909943|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.87||0.972|TWO_SIDED|95.0|-1.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.7|-1.7|0.9720
71909944|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.82||0.4758|TWO_SIDED|95.0|-2.2|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||1.0|-2.2|0.4758
71909945|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|1.03||0.4419|TWO_SIDED|95.0|-2.8|1.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.2|-2.8|0.4419
71909946|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.91||0.4762|TWO_SIDED|95.0|-2.4|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-2.4|0.4762
71909947|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.4|STANDARD_ERROR_OF_MEAN|0.86||0.1046|TWO_SIDED|95.0|-3.1|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-3.1|0.1046
71909948|NCT01617187|143340824|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1411|TWO_SIDED|95.0|-3.7|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.5|-3.7|0.1411
71909949|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2754|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2754
71863672|NCT02209181|143241780|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|0.46|<|0.001|TWO_SIDED|95.0|-3.0|-1.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.17|-3.00|<0.001
71863673|NCT02209181|143241781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.87|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|3.9|5.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.84|3.90|<0.001
71909950|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.39||0.85|TWO_SIDED|95.0|-0.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.8|0.8500
71909951|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8439|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.9|-1.1|0.8439
71909952|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.51||0.4741|TWO_SIDED|95.0|-1.4|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.4|0.4741
71909953|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.2158|TWO_SIDED|95.0|-1.6|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.4|-1.6|0.2158
71909954|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.63||0.506|TWO_SIDED|95.0|-1.7|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.8|-1.7|0.5060
71909955|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9956|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-1.1|0.9956
71909956|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.1624|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.3|-1.8|0.1624
71909957|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.68||0.7662|TWO_SIDED|95.0|-1.5|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||1.1|-1.5|0.7662
71909958|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.61||0.8363|TWO_SIDED|95.0|-1.3|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.1|-1.3|0.8363
71863674|NCT02209181|143241781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.13|STANDARD_ERROR_OF_MEAN|0.49||0.023|TWO_SIDED|95.0|0.16|2.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.09|0.16|0.023
71863675|NCT02209181|143241781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.96|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|1.98|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.93|1.98|<0.001
71863676|NCT02209181|143241781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|0.49|<|0.001|TWO_SIDED|95.0|-4.71|-2.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.78|-4.71|<0.001
71863677|NCT02209181|143241781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-2.89|-0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.94|-2.89|<0.001
71863678|NCT02209181|143241782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.71|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|3.64|5.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.78|3.64|<0.001
71863679|NCT02209181|143241782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|0.54||0.012|TWO_SIDED|95.0|0.3|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.42|0.30|0.012
71863680|NCT02209181|143241782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.73|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|2.66|4.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.81|2.66|<0.001
71863681|NCT02209181|143241782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.35|STANDARD_ERROR_OF_MEAN|0.54|<|0.001|TWO_SIDED|95.0|-4.41|-2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-2.29|-4.41|<0.001
71863682|NCT02209181|143241782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|0.54||0.074|TWO_SIDED|95.0|-2.05|0.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.09|-2.05|0.074
71863683|NCT02209181|143241783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.8|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|2.63|4.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.97|2.63|<0.001
71863684|NCT02209181|143241783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|0.59||0.026|TWO_SIDED|95.0|0.16|2.48||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.48|0.16|0.026
71863685|NCT02209181|143241783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.82|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|2.64|4.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.99|2.64|<0.001
71863686|NCT02209181|143241783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.59|<|0.001|TWO_SIDED|95.0|-3.64|-1.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.32|-3.64|<0.001
71863687|NCT02209181|143241783|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.6||0.978|TWO_SIDED|95.0|-1.16|1.19||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.19|-1.16|0.978
71863688|NCT02209181|143241784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.18|4.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.62|2.18|<0.001
71863689|NCT02209181|143241784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|0.61||0.081|TWO_SIDED|95.0|-0.13|2.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.28|-0.13|0.081
71909959|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.58||0.2388|TWO_SIDED|95.0|-1.8|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.5|-1.8|0.2388
71909960|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.9435|TWO_SIDED|95.0|-1.5|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-1.5|0.9435
71909961|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4267|TWO_SIDED|95.0|-0.8|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.9|-0.8|0.4267
71909962|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.681|TWO_SIDED|95.0|-1.6|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.0|-1.6|0.6810
71863690|NCT02209181|143241784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.91|STANDARD_ERROR_OF_MEAN|0.62|<|0.001|TWO_SIDED|95.0|2.69|5.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||5.14|2.69|<0.001
71681875|NCT00793624|142881824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.381|STANDARD_ERROR_OF_MEAN|0.34||0.2625||95.0|-0.285|1.047|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||1.047|-0.285|0.2625
71863691|NCT02209181|143241784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-2.32|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|-3.53|-1.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-1.11|-3.53|<0.001
71909963|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.82||0.7673|TWO_SIDED|95.0|-1.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.9|-1.4|0.7673
71909964|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.7||0.483|TWO_SIDED|95.0|-1.9|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.9|-1.9|0.4830
71909965|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.66||0.2128|TWO_SIDED|95.0|-2.1|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.5|-2.1|0.2128
71909966|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.83||0.1756|TWO_SIDED|95.0|-2.8|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.5|-2.8|0.1756
71909967|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.4246|TWO_SIDED|95.0|-0.8|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||2.0|-0.8|0.4246
71909968|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.68||0.2873|TWO_SIDED|95.0|-2.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.6|-2.1|0.2873
71909969|NCT01617187|143340825|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.7308|TWO_SIDED|95.0|-1.9|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.4|-1.9|0.7308
71909970|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2116|TWO_SIDED|95.0|-0.2|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||1.0|-0.2|0.2116
71909971|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9039|TWO_SIDED|95.0|-0.6|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.7|-0.6|0.9039
71909972|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.2959|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.4|-1.2|0.2959
71909973|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.44||0.5909|TWO_SIDED|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.6|-1.1|0.5909
71909974|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1489|TWO_SIDED|95.0|-1.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.2|-1.4|0.1489
71909975|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.9|STANDARD_ERROR_OF_MEAN|0.54||0.1|TWO_SIDED|95.0|-2.0|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.2|-2.0|0.1000
71909976|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.49||0.783|TWO_SIDED|95.0|-0.8|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.1|-0.8|0.7830
71909977|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.47||0.2679|TWO_SIDED|95.0|-1.4|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.4|0.2679
71909978|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2321|TWO_SIDED|95.0|-1.9|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.5|-1.9|0.2321
71909979|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.56||0.7368|TWO_SIDED|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||0.9|-1.3|0.7368
71909980|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.53||0.4606|TWO_SIDED|95.0|-1.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.7|-1.4|0.4606
71909981|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.3241|TWO_SIDED|95.0|-2.0|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.7|-2.0|0.3241
71909982|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.57||0.986|TWO_SIDED|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.1|-1.1|0.9860
71909983|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.53||0.189|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||0.3|-1.8|0.1890
71909984|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.67||0.303|TWO_SIDED|95.0|-2.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-2.0|0.3030
71909985|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.58||0.055|TWO_SIDED|95.0|-2.3|0.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||0.0|-2.3|0.0550
71909986|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.55||0.0415|TWO_SIDED|95.0|-2.2|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||-0.0|-2.2|0.0415
71909987|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.9|STANDARD_ERROR_OF_MEAN|0.69||0.0058|TWO_SIDED|95.0|-3.3|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||-0.6|-3.3|0.0058
71909988|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.1|STANDARD_ERROR_OF_MEAN|0.62||0.0691|TWO_SIDED|95.0|-2.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||0.1|-2.3|0.0691
71909989|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-1.6|STANDARD_ERROR_OF_MEAN|0.58||0.0063|TWO_SIDED|95.0|-2.7|-0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||-0.5|-2.7|0.0063
71909990|NCT01617187|143340826|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-2.0|STANDARD_ERROR_OF_MEAN|0.71||0.0056|TWO_SIDED|95.0|-3.4|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||-0.6|-3.4|0.0056
71909991|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.7847|TWO_SIDED|95.0|-0.6|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.8|-0.6|0.7847
71909992|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5859|TWO_SIDED|95.0|-0.5|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.8|-0.5|0.5859
71909993|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.43||0.6413|TWO_SIDED|95.0|-1.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.6|-1.0|0.6413
71863692|NCT02209181|143241784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.62||0.407|TWO_SIDED|95.0|-0.71|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.71|0.407
71681876|NCT00793624|142881824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.543|STANDARD_ERROR_OF_MEAN|0.341||0.1109||95.0|-0.125|1.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.211|-0.125|0.1109
71863693|NCT02209181|143241785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.83|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.56|4.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.10|1.56|<0.001
71909994|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.38||0.7307|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7307
71909995|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.37||0.7176|TWO_SIDED|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.9|-0.6|0.7176
71909996|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.48||0.486|TWO_SIDED|95.0|-1.3|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.6|-1.3|0.4860
71909997|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.9321|TWO_SIDED|95.0|-0.8|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||0.8|-0.8|0.9321
71909998|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.39||0.7691|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.9|-0.7|0.7691
71909999|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.3|STANDARD_ERROR_OF_MEAN|0.5||0.5694|TWO_SIDED|95.0|-1.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.7|-1.3|0.5694
71863694|NCT02209181|143241785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.64||0.17|TWO_SIDED|95.0|-0.38|2.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.14|-0.38|0.170
71863695|NCT02209181|143241785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.6|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.33|4.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.87|2.33|<0.001
71910000|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.45||0.5583|TWO_SIDED|95.0|-0.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.2|-0.6|0.5583
71910001|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.43||0.7307|TWO_SIDED|95.0|-0.7|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||1.0|-0.7|0.7307
71910002|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.54||0.1715|TWO_SIDED|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||0.3|-1.8|0.1715
71910003|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.4|STANDARD_ERROR_OF_MEAN|0.55||0.4219|TWO_SIDED|95.0|-0.6|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||1.5|-0.6|0.4219
71681877|NCT00793624|142881824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.394|STANDARD_ERROR_OF_MEAN|0.343||0.2507||95.0|-0.278|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||1.066|-0.278|0.2507
71863696|NCT02209181|143241785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|0.64||0.002|TWO_SIDED|95.0|-3.21|-0.69||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.69|-3.21|0.002
71910004|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.52||0.7437|TWO_SIDED|95.0|-0.9|1.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.2|-0.9|0.7437
71910005|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.65||0.311|TWO_SIDED|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||0.6|-1.9|0.3110
71910006|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.5||0.9805|TWO_SIDED|95.0|-1.0|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.0|-1.0|0.9805
71910007|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.8741|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.8|-1.0|0.8741
71910008|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.6|STANDARD_ERROR_OF_MEAN|0.58||0.3288|TWO_SIDED|95.0|-1.7|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||0.6|-1.7|0.3288
71910009|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.56||0.9336|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.9336
71910010|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.7|STANDARD_ERROR_OF_MEAN|0.52||0.1722|TWO_SIDED|95.0|-1.7|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.3|-1.7|0.1722
71910011|NCT01617187|143340827|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.8|STANDARD_ERROR_OF_MEAN|0.64||0.1909|TWO_SIDED|95.0|-2.1|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||0.4|-2.1|0.1909
71910012|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.9851|TWO_SIDED|95.0|-0.7|0.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4||0.7|-0.7|0.9851
71681878|NCT00793624|142881825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.232|STANDARD_ERROR_OF_MEAN|0.342||0.4895||95.0|-0.439|0.902|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.902|-0.439|0.4895
71910013|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.2|STANDARD_ERROR_OF_MEAN|0.36||0.4912|TWO_SIDED|95.0|-0.9|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4||0.5|-0.9|0.4912
71910014|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.46||0.8559|TWO_SIDED|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4||0.8|-1.0|0.8559
71910015|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.41||0.5635|TWO_SIDED|95.0|-0.6|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7||1.1|-0.6|0.5635
71910016|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.4||0.2321|TWO_SIDED|95.0|-1.3|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7||0.3|-1.3|0.2321
71910017|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.52||0.8867|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7||0.9|-1.1|0.8867
71910018|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.42||0.1499|TWO_SIDED|95.0|-0.2|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14||1.4|-0.2|0.1499
71910019|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.4|STANDARD_ERROR_OF_MEAN|0.4||0.286|TWO_SIDED|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14||0.4|-1.2|0.2860
71910020|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.8978|TWO_SIDED|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14||0.9|-1.1|0.8978
71910021|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.0|STANDARD_ERROR_OF_MEAN|0.44||0.0283|TWO_SIDED|95.0|0.1|1.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21||1.8|0.1|0.0283
71910022|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.8667|TWO_SIDED|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21||0.9|-0.7|0.8667
71910023|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.3|STANDARD_ERROR_OF_MEAN|0.52||0.5044|TWO_SIDED|95.0|-0.7|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21||1.4|-0.7|0.5044
71910024|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|1.4|STANDARD_ERROR_OF_MEAN|0.49||0.004|TWO_SIDED|95.0|0.5|2.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28||2.4|0.5|0.0040
71910025|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.46||0.633|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28||1.1|-0.7|0.6330
71910026|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.6|STANDARD_ERROR_OF_MEAN|0.57||0.2981|TWO_SIDED|95.0|-0.5|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28||1.7|-0.5|0.2981
71910027|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.2|STANDARD_ERROR_OF_MEAN|0.45||0.6556|TWO_SIDED|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35||1.1|-0.7|0.6556
71910028|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.43||0.2889|TWO_SIDED|95.0|-1.3|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35||0.4|-1.3|0.2889
71910029|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.0|STANDARD_ERROR_OF_MEAN|0.53||0.9399|TWO_SIDED|95.0|-1.1|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35||1.0|-1.1|0.9399
71910030|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|0.1|STANDARD_ERROR_OF_MEAN|0.54||0.8955|TWO_SIDED|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42||1.1|-1.0|0.8955
71910031|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.3681|TWO_SIDED|95.0|-1.5|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42||0.5|-1.5|0.3681
71910032|NCT01617187|143340828|SUPERIORITY_OR_OTHER_LEGACY||LS means difference|-0.1|STANDARD_ERROR_OF_MEAN|0.62||0.8215|TWO_SIDED|95.0|-1.4|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42||1.1|-1.4|0.8215
71910033|NCT00595868|143340841|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.06|TWO_SIDED|95.0|1.0|2.9|||Chi-squared|||||2.9|1.0|0.06
71910034|NCT00595868|143340842|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.1||||0.1|TWO_SIDED|95.0|0.9|5.2|||Chi-squared|||||5.2|0.9|0.10
71910035|NCT04268303|143340847|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71910036|NCT04268303|143340847|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71910037|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
71910038|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
71910039|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
71910040|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
71910041|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
71910042|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
71910043|NCT04268303|143340848|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||<0.0001
71910044|NCT04268303|143340848|SUPERIORITY|||||||0.0075|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0075
71910045|NCT04268303|143340848|SUPERIORITY|||||||0.0032|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0032
71910046|NCT04268303|143340848|SUPERIORITY|||||||0.4097|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.4097
71910047|NCT04268303|143340848|SUPERIORITY|||||||0.0457|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 10 minutes post-dose||||0.0457
71681879|NCT00793624|142881825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.434|STANDARD_ERROR_OF_MEAN|0.344||0.2073||95.0|-0.24|1.107|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.107|-0.240|0.2073
71910048|NCT04268303|143340848|SUPERIORITY|||||||0.972|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 10 minutes post-dose||||0.9720
71910049|NCT05742841|143340854|SUPERIORITY||Median Difference (Final Values)|-16.5|||||TWO_SIDED|||||||||||||
71910050|NCT00510484|143340855|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910051|NCT00510484|143340856|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910052|NCT00510484|143340857|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910053|NCT00510484|143340858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910054|NCT00510484|143340859|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910055|NCT00510484|143340860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910056|NCT00510484|143340861|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.013
71910057|NCT00510484|143340862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71910058|NCT00961441|143340863|SUPERIORITY_OR_OTHER||Point estimate for ratio|1.0271|||||TWO_SIDED|90.0|0.8817|1.1964|||ANOVA|Point estimates for the geometric means ratios children/adults for Cmax normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.1964|0.8817|
71910059|NCT00961441|143340864|SUPERIORITY_OR_OTHER||Point estimate for ratio|0.9914|||||TWO_SIDED|90.0|0.811|1.2118|||ANOVA|Point estimates for the geometric means ratios children/adults for AUCtau normalized by dose and body weight and 90% CIs have been calculated.||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).||1.2118|0.8110|
71910060|NCT00835003|143340914|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group|Risk Ratio (RR)|0.86||||0.31|TWO_SIDED|95.0|0.65|1.15|||Chi-squared|||||1.15|0.65|0.31
71910061|NCT04024072|143340959|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-0.93|0.01||||||||0.01|-0.93|
71910062|NCT04024072|143340959|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.23|||||TWO_SIDED|95.0|-0.7|0.24||||||||0.24|-0.70|
71910063|NCT04024072|143340959|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.24|||||TWO_SIDED|95.0|-0.74|0.27||||||||0.27|-0.74|
71910064|NCT04024072|143340959|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.51|0.51||||||||0.51|-0.51|
71910065|NCT01170221|143340993|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|0.1||||||95.0|-6.1|6.2|||||Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.||6.2|-6.1|
71910066|NCT01170221|143340994|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI will be calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-2.6|||||TWO_SIDED|95.0|-9.6|4.2||Hierarchical testing procedure of Westfall and Krishen used to control for inflation of the overall type I error rate. If NI is declared for the primary, NI will be tested for the secondary outcomes in this order: Secondary Outcomes Measures 2 to 5.|||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||4.2|-9.6|
71681880|NCT00793624|142881825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.345||0.9462||95.0|-0.653|0.7|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.700|-0.653|0.9462
71681881|NCT00793624|142881826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.345||0.6309||95.0|-0.511|0.842|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.842|-0.511|0.6309
71681882|NCT00793624|142881826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|STANDARD_ERROR_OF_MEAN|0.348||0.9227||95.0|-0.717|0.649|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.649|-0.717|0.9227
71863697|NCT02209181|143241785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.65||0.235|TWO_SIDED|95.0|-0.5|2.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.04|-0.50|0.235
71863698|NCT02209181|143241786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|0.65||0.001|TWO_SIDED|95.0|0.82|3.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.39|0.82|0.001
71863699|NCT02209181|143241786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.65||0.355|TWO_SIDED|95.0|-0.68|1.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.87|-0.68|0.355
71863700|NCT02209181|143241786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.36|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|2.07|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.65|2.07|<0.001
71863701|NCT02209181|143241786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.65||0.021|TWO_SIDED|95.0|-2.78|-0.23||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.23|-2.78|0.021
71863702|NCT02209181|143241786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.26|STANDARD_ERROR_OF_MEAN|0.65||0.056|TWO_SIDED|95.0|-0.03|2.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.55|-0.03|0.056
71863703|NCT02209181|143241787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|0.66||0.067|TWO_SIDED|95.0|-0.09|2.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.50|-0.09|0.067
71863704|NCT02209181|143241787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.65||0.547|TWO_SIDED|95.0|-0.89|1.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.68|-0.89|0.547
71863705|NCT02209181|143241787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.16|STANDARD_ERROR_OF_MEAN|0.66|<|0.001|TWO_SIDED|95.0|1.86|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.46|1.86|<0.001
71863706|NCT02209181|143241787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.65||0.214|TWO_SIDED|95.0|-2.1|0.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.47|-2.10|0.214
71863707|NCT02209181|143241787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.96|STANDARD_ERROR_OF_MEAN|0.66||0.003|TWO_SIDED|95.0|0.66|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.26|0.66|0.003
71863708|NCT02209181|143241788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.64||0.281|TWO_SIDED|95.0|-0.57|1.95||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.95|-0.57|0.281
71863709|NCT02209181|143241788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.63||0.729|TWO_SIDED|95.0|-1.03|1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.47|-1.03|0.729
71863710|NCT02209181|143241788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.21|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.95|4.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.47|1.95|<0.001
71863711|NCT02209181|143241788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.63||0.459|TWO_SIDED|95.0|-1.72|0.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.78|-1.72|0.459
71681883|NCT00793624|142881826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.234|STANDARD_ERROR_OF_MEAN|0.349||0.503||95.0|-0.451|0.919|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.919|-0.451|0.5030
71922125|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|1.98|STANDARD_ERROR_OF_MEAN|5.21|||TWO_SIDED|95.0|-8.85|12.81|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||12.81|-8.85|
71681884|NCT00793624|142881827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.112|STANDARD_ERROR_OF_MEAN|0.347||0.7459||95.0|-0.793|0.568|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.568|-0.793|0.7459
71681885|NCT00793624|142881827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.065|STANDARD_ERROR_OF_MEAN|0.351||0.8534||95.0|-0.753|0.623|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.623|-0.753|0.8534
71681886|NCT00793624|142881827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.377|STANDARD_ERROR_OF_MEAN|0.352||0.5099||95.0|-1.068|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.314|-1.068|0.5099
71681887|NCT00793624|142881828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095|STANDARD_ERROR_OF_MEAN|0.348||0.785||95.0|-0.587|0.777|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.777|-0.587|0.7850
71681888|NCT00793624|142881828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.383|STANDARD_ERROR_OF_MEAN|0.352||0.2755||95.0|-0.306|1.073|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||1.073|-0.306|0.2755
71863712|NCT02209181|143241788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.26|3.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.78|1.26|<0.001
71863713|NCT02209181|143241789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.65||0.674|TWO_SIDED|95.0|-1.0|1.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.55|-1.00|0.674
71863714|NCT02209181|143241789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.64||0.417|TWO_SIDED|95.0|-0.74|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.74|0.417
71863715|NCT02209181|143241789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.05|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.77|4.33||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.33|1.77|<0.001
71681889|NCT00793624|142881828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.107|STANDARD_ERROR_OF_MEAN|0.353||0.7618||95.0|-0.584|0.798|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo|||0.798|-0.584|0.7618
71681890|NCT00793624|142881829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.162|STANDARD_ERROR_OF_MEAN|0.19||0.3424||95.0|0.843|1.603|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.603|0.843|0.3424
71681891|NCT00793624|142881829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.186|STANDARD_ERROR_OF_MEAN|0.195||0.3023||95.0|0.859|1.636|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.636|0.859|0.3023
71681892|NCT00793624|142881829|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.854|STANDARD_ERROR_OF_MEAN|0.15||0.3589||95.0|0.605|1.205|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.205|0.605|0.3589
71681893|NCT00793624|142881830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.818|STANDARD_ERROR_OF_MEAN|0.841||0.191||95.0|0.734|4.503|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||4.503|0.734|0.1910
71681894|NCT00793624|142881830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.743|STANDARD_ERROR_OF_MEAN|0.817||0.2274||95.0|0.695|4.369|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||4.369|0.695|0.2274
71681895|NCT00793624|142881830|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.346|STANDARD_ERROR_OF_MEAN|0.664||0.5538||95.0|0.512|3.538|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||3.538|0.512|0.5538
71681896|NCT00793624|142881831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.101|STANDARD_ERROR_OF_MEAN|0.195||0.5577||95.0|0.778|1.557|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.557|0.778|0.5577
71910067|NCT01170221|143340995|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-7.7|5.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|||5.4|-7.7|
71681897|NCT00793624|142881831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.017|STANDARD_ERROR_OF_MEAN|0.184||0.9423||95.0|0.714|1.448|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.448|0.714|0.9423
71863716|NCT02209181|143241789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.64||0.698|TWO_SIDED|95.0|-1.02|1.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.52|-1.02|0.698
71863717|NCT02209181|143241789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.77|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.49|4.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.05|1.49|<0.001
71910068|NCT01170221|143340996|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.5|||||TWO_SIDED|95.0|-5.8|4.9|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||4.9|-5.8|
71910069|NCT01170221|143340997|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.8|||||TWO_SIDED|95.0|-4.6|3.0|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.|||3.0|-4.6|
71681898|NCT00793624|142881831|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.735|STANDARD_ERROR_OF_MEAN|0.143||0.1097||95.0|0.502|1.076|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum|||1.076|0.502|0.1097
71863718|NCT02209181|143241790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.64||0.541|TWO_SIDED|95.0|-0.87|1.66||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.66|-0.87|0.541
71863719|NCT02209181|143241790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.64||0.409|TWO_SIDED|95.0|-0.73|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.79|-0.73|0.409
71863720|NCT02209181|143241790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|3.12|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.85|4.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.39|1.85|<0.001
71863721|NCT02209181|143241790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.64||0.834|TWO_SIDED|95.0|-1.12|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.12|0.834
71863722|NCT02209181|143241790|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.45|4.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.00|1.45|<0.001
71863723|NCT02209181|143241791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.64||0.573|TWO_SIDED|95.0|-0.9|1.63||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.63|-0.90|0.573
71863724|NCT02209181|143241791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|0.64||0.448|TWO_SIDED|95.0|-0.77|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.74|-0.77|0.448
71863725|NCT02209181|143241791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.98|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.71|4.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.25|1.71|<0.001
71863726|NCT02209181|143241791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.64||0.848|TWO_SIDED|95.0|-1.13|1.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.38|-1.13|0.848
71863727|NCT02209181|143241791|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.62|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|1.35|3.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.89|1.35|<0.001
71863728|NCT02209181|143241792|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.64||0.72|TWO_SIDED|95.0|-1.04|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.04|0.720
71863729|NCT02209181|143241792|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.64||0.763|TWO_SIDED|95.0|-1.07|1.45||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.45|-1.07|0.763
71863730|NCT02209181|143241792|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.82|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.55|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.09|1.55|<0.001
71863731|NCT02209181|143241792|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.64||0.952|TWO_SIDED|95.0|-1.3|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.30|0.952
71863732|NCT02209181|143241792|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.59|STANDARD_ERROR_OF_MEAN|0.65|<|0.001|TWO_SIDED|95.0|1.31|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.86|1.31|<0.001
71681899|NCT00793624|142881832|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2521|STANDARD_ERROR_OF_MEAN|0.2064||0.1729||95.0|0.906|1.7304|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7304|0.9060|0.1729
71681900|NCT00793624|142881832|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.222|STANDARD_ERROR_OF_MEAN|0.2039||0.2297||95.0|0.8808|1.6954|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.6954|0.8808|0.2297
71681901|NCT00793624|142881832|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.8968|STANDARD_ERROR_OF_MEAN|0.1575||0.5354||95.0|0.6353|1.2659|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.2659|0.6353|0.5354
71681902|NCT00793624|142881833|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.8821|STANDARD_ERROR_OF_MEAN|1.0358||0.2508||95.0|0.6391|5.543|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||5.5430|0.6391|0.2508
71910070|NCT01170221|143340998|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.5|||||TWO_SIDED|95.0|-1.4|8.5|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||8.5|-1.4|
71910071|NCT01170221|143340999|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.7|||||TWO_SIDED|95.0|-2.8|6.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.||6.4|-2.8|
71910072|NCT01488409|143341001|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED||||||t-test, 2 sided|||||||0.97
71910073|NCT01488409|143341002|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
71910074|NCT01488409|143341003|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
71910075|NCT01488409|143341004|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
71910076|NCT01488409|143341005|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||||||0.007
71910077|NCT01948141|143341014|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||||||0.59
71910078|NCT01948141|143341017|SUPERIORITY_OR_OTHER|||||||0.36|||||||Log Rank|||||||0.36
71910079|NCT03796182|143341028|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|98.5|||||TWO_SIDED|90.0|82.09|118.2||||||||118.20|82.09|
71910080|NCT03796182|143341029|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|93.49|||||TWO_SIDED|90.0|85.15|102.65||||||||102.65|85.15|
71910081|NCT03796182|143341030|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|88.07|||||TWO_SIDED|90.0|80.99|95.76||||||||95.76|80.99|
71910082|NCT03796182|143341032|EQUIVALENCE|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|94.25|||||TWO_SIDED|90.0|88.19|100.73||||||||100.73|88.19|
71910083|NCT04682353|143341045|OTHER||Geometric Mean Ratio|0.976|||||TWO_SIDED|90.0|0.748|1.274||||||||1.274|0.748|
71910084|NCT04682353|143341045|OTHER||Geometric Mean Ratio|1.226|||||TWO_SIDED|90.0|0.94|1.598||||||||1.598|0.940|
71910085|NCT04682353|143341045|OTHER||Geometric Mean Ratio|1.817|||||TWO_SIDED|90.0|1.38|2.392||||||||2.392|1.380|
71910086|NCT04682353|143341047|OTHER||Geometric Mean Ratio|1.202|||||TWO_SIDED|90.0|0.96|1.506||||||||1.506|0.960|
71910087|NCT04682353|143341047|OTHER||Geometric Mean Ratio|1.393|||||TWO_SIDED|90.0|1.07|1.815||||||||1.815|1.070|
71910088|NCT04682353|143341047|OTHER||Geometric Mean Ratio|2.301|||||TWO_SIDED|90.0|1.806|2.933||||||||2.933|1.806|
71910089|NCT04682353|143341048|OTHER||Geometric Mean Ratio|1.699|||||TWO_SIDED|90.0|0.921|3.135||||||||3.135|0.921|
71910090|NCT04682353|143341048|OTHER||Geometric Mean Ratio|2.364|||||TWO_SIDED|90.0|1.273|4.39||||||||4.390|1.273|
71910091|NCT04682353|143341048|OTHER||Geometric Mean Ratio|3.748|||||TWO_SIDED|90.0|2.033|6.908||||||||6.908|2.033|
71910092|NCT04682353|143341049|OTHER||Geometric Mean Ratio|1.904|||||TWO_SIDED|90.0|0.886|4.093||||||||4.093|0.886|
71910093|NCT04682353|143341049|OTHER||Geometric Mean Ratio|3.317|||||TWO_SIDED|90.0|1.585|6.942||||||||6.942|1.585|
71910094|NCT04682353|143341049|OTHER||Geometric Mean Ratio|5.824|||||TWO_SIDED|90.0|2.796|12.135||||||||12.135|2.796|
71910095|NCT04682353|143341050|OTHER||Geometric Mean Ratio|1.095|||||TWO_SIDED|90.0|0.92|1.302||||||||1.302|0.920|
71910096|NCT04682353|143341050|OTHER||Geometric Mean Ratio|1.415|||||TWO_SIDED|90.0|1.148|1.744||||||||1.744|1.148|
71910097|NCT04682353|143341050|OTHER||Geometric Mean Ratio|2.017|||||TWO_SIDED|90.0|1.692|2.405||||||||2.405|1.692|
71910098|NCT04682353|143341051|OTHER||Geometric Mean Ratio|1.112|||||TWO_SIDED|90.0|0.948|1.303||||||||1.303|0.948|
71910099|NCT04682353|143341051|OTHER||Geometric Mean Ratio|1.439|||||TWO_SIDED|90.0|1.174|1.762||||||||1.762|1.174|
71910100|NCT04682353|143341051|OTHER||Geometric Mean Ratio|2.075|||||TWO_SIDED|90.0|1.751|2.459||||||||2.459|1.751|
71910101|NCT04682353|143341052|OTHER||Geometric Mean Ratio|1.115|||||TWO_SIDED|90.0|0.993|1.252||||||||1.252|0.993|
71910102|NCT04682353|143341052|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|90.0|1.277|1.833||||||||1.833|1.277|
71910103|NCT04682353|143341052|OTHER||Geometric Mean Ratio|2.14|||||TWO_SIDED|90.0|1.888|2.425||||||||2.425|1.888|
71681903|NCT00793624|142881833|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.3877|STANDARD_ERROR_OF_MEAN|1.3119||0.1135||95.0|0.8122|7.0194|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||7.0194|0.8122|0.1135
71681904|NCT00793624|142881833|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0289|STANDARD_ERROR_OF_MEAN|0.6013||0.9611||95.0|0.3268|3.2395|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||3.2395|0.3268|0.9611
71681905|NCT00793624|142881834|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1621|STANDARD_ERROR_OF_MEAN|0.2075||0.4002||95.0|0.8187|1.6497|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.6497|0.8187|0.4002
71910104|NCT00862654|143341074|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||<0.01
71910105|NCT00862654|143341074|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.||||0.039
71910106|NCT03219567|143341094|OTHER|||||||0.35|||||||t-test, 2 sided|||OCT compared to MRI||||0.35
71910107|NCT03954444|143341114|EQUIVALENCE|90% Confidence Interval, should be within -20% to +20%|Mean Difference (Net)|2.7|||||TWO_SIDED|90.0|-2.6|8.0||||||||8.0|-2.6|
71910108|NCT03954444|143341114|SUPERIORITY|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
71910109|NCT03954444|143341114|SUPERIORITY|||||||0.1126|||||||Cochran-Mantel-Haenszel|||||||0.1126
71910110|NCT03846219|143341174|SUPERIORITY||rate ratio|0.38||||0.0002|TWO_SIDED|95.0|0.22|0.64||A one-sided alpha level of 0.1 was used.|generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 45 mg IMU-838 / placebo|H0: cumulative number of CUA MRI lesions up to Week 24 with 45 mg IMU-838 equal to or higher than that with placebo. A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term. 51 patients per group were necessary to have 80% power to detect a difference of 3.5 in mean event rate with a significance level 0.1, 1-sided.||0.64|0.22|0.0002
71910111|NCT03846219|143341175|SUPERIORITY||Rate ratio|0.3|||<|0.0001|TWO_SIDED|95.0|0.17|0.53||A hierarchical testing procedure with a one-sided alpha level of 0.1 was used.|Generalized linear model|Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1).|Rate ratio of 30 mg IMU-838 / placebo|A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term.||0.53|0.17|<.0001
71910112|NCT04491240|143341239|SUPERIORITY||Mean Difference (Net)|73.29|STANDARD_DEVIATION|82.91404||0.020875|TWO_SIDED|95.0|13.97687|132.6031|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||132.6031|13.97687|0.020875
71910113|NCT04491240|143341239|SUPERIORITY||Mean Difference (Net)|69.56|STANDARD_DEVIATION|45.67648||0.000953|TWO_SIDED|95.0|36.88502|102.235|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||102.2350|36.88502|0.000953
71910114|NCT04491240|143341239|SUPERIORITY||Mean Difference (Net)|53.21|STANDARD_DEVIATION|39.85531||0.002233|TWO_SIDED|95.0|24.69923|81.72077|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||81.72077|24.69923|0.002233
71922126|NCT03091920|143364996|OTHER|No statistical testing was performed.|Least squares mean difference|1.07|STANDARD_ERROR_OF_MEAN|4.69|||TWO_SIDED|95.0|-8.68|10.82|||||Least squares mean difference and associated 95% CI are from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||10.82|-8.68|
71922127|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-2.12|STANDARD_ERROR_OF_MEAN|2.06|||TWO_SIDED|95.0|-6.38|2.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.15|-6.38|
71922128|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-2.39|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|95.0|-6.59|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.80|-6.59|
71681906|NCT00793624|142881834|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0733|STANDARD_ERROR_OF_MEAN|0.1957||0.6983||95.0|0.7503|1.5352|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.5352|0.7503|0.6983
71910115|NCT04491240|143341240|SUPERIORITY||Mean Difference (Net)|331.52|STANDARD_DEVIATION|315.823||0.008948|TWO_SIDED|95.0|105.5938|557.4462|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||557.4462|105.5938|0.008948
71910116|NCT04491240|143341240|SUPERIORITY||Mean Difference (Net)|366.63|STANDARD_DEVIATION|414.9726||0.020921|TWO_SIDED|95.0|69.77651|663.4835|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||663.4835|69.77651|0.020921
71910117|NCT04491240|143341240|SUPERIORITY||Mean Difference (Net)|239.2|STANDARD_DEVIATION|204.0934||0.004873|TWO_SIDED|95.0|93.20037|385.1996|||t-test, 2 sided|||The study results were statistically processed using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of inhalation and after were compared using the T-test for depended group criterion, data between the main group and the control group were compared using the non-parametric method, box-plot. The data in the table presented as a Mean with full range (min-max). The difference calculated as Mean difference with 95% confidence interval and Standard Deviation (SD)||385.1996|93.20037|0.004873
71910118|NCT03549117|143341241|SUPERIORITY||Least square (LS) mean difference|0.15||||0.8142|TWO_SIDED|95.0|-1.14|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.45|-1.14|0.8142
71910119|NCT03549117|143341241|SUPERIORITY||LS mean difference|-0.7||||0.369|TWO_SIDED|95.0|-2.23|0.84||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||0.84|-2.23|0.3690
71910120|NCT03549117|143341241|SUPERIORITY||LS mean difference|-0.18||||0.7995|TWO_SIDED|95.0|-1.61|1.25||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline; between treatment 95% CI.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||1.25|-1.61|0.7995
71910121|NCT03549117|143341241|SUPERIORITY||LS mean difference|0.15||||0.7285|TWO_SIDED|95.0|-0.69|0.98||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.98|-0.69|0.7285
71910122|NCT03549117|143341242|SUPERIORITY||LS mean difference|-0.18||||0.7961|TWO_SIDED|95.0|-1.52|1.17||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||1.17|-1.52|0.7961
71910123|NCT03549117|143341242|SUPERIORITY||LS mean difference|-0.86||||0.271|TWO_SIDED|95.0|-2.41|0.68||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.68|-2.41|0.2710
71910124|NCT03549117|143341242|SUPERIORITY||LS mean difference|-0.07||||0.9236|TWO_SIDED|95.0|-1.6|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||1.45|-1.60|0.9236
71910125|NCT03549117|143341242|SUPERIORITY||LS mean difference|-0.05||||0.8756|TWO_SIDED|95.0|-0.87|0.75||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.75|-0.87|0.8756
71910126|NCT03549117|143341243|SUPERIORITY||LS mean difference|0.02||||0.9314|TWO_SIDED|95.0|-0.38|0.42||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.42|-0.38|0.9314
71910127|NCT03549117|143341243|SUPERIORITY||LS mean difference|-0.05||||0.8005|TWO_SIDED|95.0|-0.45|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.45|0.8005
71681907|NCT00793624|142881834|SUPERIORITY_OR_OTHER||Incidence rate ratio|0.781|STANDARD_ERROR_OF_MEAN|0.1516||0.2033||95.0|0.5336|1.1433|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo|||1.1433|0.5336|0.2033
71863733|NCT02209181|143241793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.63||0.821|TWO_SIDED|95.0|-1.1|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.39|-1.10|0.821
71863734|NCT02209181|143241793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.63||0.978|TWO_SIDED|95.0|-1.25|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.22|-1.25|0.978
71863735|NCT02209181|143241793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.63|4.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.13|1.63|<0.001
71681908|NCT00793624|142881837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.509|STANDARD_ERROR_OF_MEAN|0.23||0.027||95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo||0.960|0.058|0.0270
71863736|NCT02209181|143241793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.63||0.799|TWO_SIDED|95.0|-1.39|1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.07|-1.39|0.799
71681909|NCT00793624|142881837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.525|STANDARD_ERROR_OF_MEAN|0.226||0.0203||95.0|0.082|0.967||See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|pattern mixture model||"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo||0.967|0.082|0.0203
71863737|NCT02209181|143241793|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.73|STANDARD_ERROR_OF_MEAN|0.63|<|0.001|TWO_SIDED|95.0|1.49|3.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.98|1.49|<0.001
71863738|NCT02209181|143241794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.7||0.726|TWO_SIDED|95.0|-1.62|1.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.13|-1.62|0.726
71681910|NCT00793624|142881837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.355|STANDARD_ERROR_OF_MEAN|0.226||0.1166||95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455-1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1\) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo||0.799|-0.088|0.1166
71863739|NCT02209181|143241794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.69||0.869|TWO_SIDED|95.0|-1.48|1.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.25|-1.48|0.869
71863740|NCT02209181|143241794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.52|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.13|3.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||3.90|1.13|<0.001
71863741|NCT02209181|143241794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.69||0.851|TWO_SIDED|95.0|-1.24|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.50|-1.24|0.851
71863742|NCT02209181|143241794|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.76|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.38|4.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||4.15|1.38|<0.001
71863743|NCT02209181|143241795|SUPERIORITY_OR_OTHER|||||||0.042||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.042
71863744|NCT02209181|143241795|SUPERIORITY_OR_OTHER|||||||0.779||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.779
71863745|NCT02209181|143241795|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||<0.001
71910128|NCT03549117|143341243|SUPERIORITY||LS mean difference|0.01||||0.9613|TWO_SIDED|95.0|-0.38|0.4||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.38|0.9613
71910129|NCT03549117|143341243|SUPERIORITY||LS mean difference|-0.14||||0.4966|TWO_SIDED|95.0|-0.54|0.26||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.26|-0.54|0.4966
71910130|NCT03549117|143341244|SUPERIORITY||LS mean difference|0.03||||0.8775|TWO_SIDED|95.0|-0.39|0.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.45|-0.39|0.8775
71910131|NCT03549117|143341244|SUPERIORITY||LS mean difference|-0.06||||0.7747|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.35|-0.47|0.7747
71910132|NCT03549117|143341244|SUPERIORITY||LS mean difference|0.04||||0.8535|TWO_SIDED|95.0|-0.39|0.47||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.47|-0.39|0.8535
71681911|NCT00710684|142881838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.279|TWO_SIDED|95.0|-1.9|0.5|||mixed model for repeated measures (MMRM)|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15mg versus placebo at Week 24||0.5|-1.9|0.279
71910133|NCT03549117|143341244|SUPERIORITY||LS mean difference|-0.06||||0.772|TWO_SIDED|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.35|-0.47|0.7720
71910134|NCT03549117|143341245|SUPERIORITY|||||||0.9258|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.9258
71910135|NCT03549117|143341245|SUPERIORITY|||||||0.2368|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.2368
71863746|NCT02209181|143241795|SUPERIORITY_OR_OTHER|||||||0.196||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.196
71863747|NCT02209181|143241795|SUPERIORITY_OR_OTHER|||||||0.006||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.||||0.006
71863748|NCT02209181|143241796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|1.1|1.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.9|1.1|<0.001
71863749|NCT02209181|143241796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.077|TWO_SIDED|95.0|0.0|0.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.8|-0.0|0.077
71863750|NCT02209181|143241796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|0.8|1.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.6|0.8|<0.001
71863751|NCT02209181|143241796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.6|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||-0.7|-1.6|<0.001
71863752|NCT02209181|143241796|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.148|TWO_SIDED|95.0|-0.7|0.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.1|-0.7|0.148
71863753|NCT02271984|143241878|SUPERIORITY_OR_OTHER||Ratio (%)|39.9|||||TWO_SIDED|90.0|34.7|46.0|||||Percentage of Geometric Least Squares (LS) Mean Ratio (Treatment A/Treatment B) is reported.|||46.0|34.7|
71863754|NCT02271984|143241878|SUPERIORITY_OR_OTHER||Ratio (%)|27.3|||||TWO_SIDED|90.0|22.5|33.2|||||Percentage of Geometric LS Mean Ratio (Treatment C1/Treatment A) is reported.|||33.2|22.5|
71863755|NCT02271984|143241878|SUPERIORITY_OR_OTHER||Ratio (%)|260.2|||||TWO_SIDED|90.0|214.0|316.4|||||Percentage of Geometric LS Mean Ratio (Treatment C2/Treatment A) is reported.|||316.4|214.0|
71863756|NCT02271984|143241878|SUPERIORITY_OR_OTHER||Ratio (%)|167.1|||||TWO_SIDED|90.0|143.9|194.0|||||Percentage of Geometric LS Mean Ratio (Treatment A/Treatment D) is reported.|||194.0|143.9|
71863757|NCT02271984|143241878|SUPERIORITY_OR_OTHER||Ratio (%)|115.7|||||TWO_SIDED|90.0|99.8|134.1|||||Percentage of Geometric LS Mean Ratio (Treatment E/Treatment A) is reported.|||134.1|99.8|
71863758|NCT04024462|143241896|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8.|Geometric Mean Ratio|1.07|||||TWO_SIDED|90.0|0.99|1.15|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of pertuzumab (Arm B) relative to the pertuzumab IV dose (Arm A).|The null hypothesis was that the pertuzumab Arm B SC dose is inferior to the pertuzumab Arm A IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of pertuzumab relative to the IV dose is not greater than 0.8).||1.15|0.99|
71863759|NCT04024462|143241897|NON_INFERIORITY|The null hypothesis could be rejected and non-inferiority concluded if the lower bound of the 90% confidence interval of the geometric mean ratio was ≥0.8. Non-inferiority was tested in hierarchical order after the primary outcome measure, to adjust for multiple statistical testing and control the type I error at one sided 5% significance level.|Geometric Mean Ratio|1.55|||||TWO_SIDED|90.0|1.44|1.67|||||The CtroughSC/CtroughIV geometric mean ratio was calculated as the SC dose of trastuzumab (Arm B) relative to the trastuzumab IV dose (Arm A).|The null hypothesis was that the trastuzumab Arm B SC dose is inferior to the Arm A trastuzumab IV dose (i.e., the CtroughSC/CtroughIV geometric mean ratio of the SC dose of trastuzumab relative to the IV dose is not greater than 0.8).||1.67|1.44|
71681912|NCT00710684|142881838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.012|TWO_SIDED|95.0|-2.7|-0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35mg versus placebo at Week 24||-0.3|-2.7|0.012
71863760|NCT04024462|143241898|OTHER|Descriptive analysis only. tpCR was analyzed outside of a hypothesis-testing framework and according to the methodology outlined in the outcome measure description.|Difference in tpCR Rate|-0.88|||||TWO_SIDED|95.0|-15.21|13.45|||||Difference in tpCR rate was calculated as Arm B: PH FDC SC minus Arm A: P+H IV.|||13.45|-15.21|
71863761|NCT00789360|143241910|OTHER||Maximum LS mean change difference|0.0917|||||TWO_SIDED|90.0|-0.028|0.212|||||Maximum difference occurred at 10 hours|The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry||0.212|-0.028|
71863762|NCT00789360|143241911|OTHER||Maximum LS mean change difference|-0.154|||||TWO_SIDED|90.0|-0.29|-0.019|||||Greatest difference occurred at 9 hours after Dose 1|||-0.019|-0.290|
71863763|NCT03559062|143241932|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
71863764|NCT03559062|143241933|OTHER||||||<|0.0001|||||||Mixed-effects model for repeated measure|||||||<0.0001
71863765|NCT03559062|143241934|OTHER|||||||0.0546|||||||Mixed-effects model for repeated measure|||||||0.0546
71863766|NCT00955708|143241983|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|95.3|||||ONE_SIDED|95.0|94.0||||||The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.|The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.|||94.0|
71910136|NCT03549117|143341245|SUPERIORITY|||||||0.4432|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4432
71910137|NCT03549117|143341245|SUPERIORITY|||||||0.9856|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.9856
71910138|NCT03549117|143341245|SUPERIORITY|||||||0.7854|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.7854
71910139|NCT03549117|143341245|SUPERIORITY|||||||0.4141|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.4141
71910140|NCT03549117|143341245|SUPERIORITY|||||||0.3028|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.3028
71910141|NCT03549117|143341245|SUPERIORITY|||||||0.3955|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3955
71910142|NCT03549117|143341246|SUPERIORITY|||||||0.3826|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.3826
71910143|NCT03549117|143341246|SUPERIORITY|||||||0.6251|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.6251
71910144|NCT03549117|143341246|SUPERIORITY|||||||0.2381|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.2381
71910145|NCT03549117|143341246|SUPERIORITY|||||||0.4245|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4245
71910146|NCT03549117|143341246|SUPERIORITY|||||||0.8213|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.8213
71910147|NCT03549117|143341246|SUPERIORITY|||||||0.1823|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.1823
71910148|NCT03549117|143341246|SUPERIORITY|||||||0.7744|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.7744
71910149|NCT03549117|143341246|SUPERIORITY|||||||0.5811|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.5811
71910150|NCT00605072|143341258|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||p-value for between group comparison (group\*visit)|Mixed Models Analysis|Adjusted for baseline AGE and Mini-Mental-State-Examination||||||0.008
71910151|NCT00605072|143341259|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Mixed Models Analysis|adjusted for age||||||0.74
71910152|NCT00605072|143341260|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||Mixed Models Analysis|Adjusted for age at baseline||||||0.81
71910153|NCT00605072|143341261|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Mixed Models Analysis|||||||0.87
71910154|NCT00605072|143341262|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Mixed Models Analysis|||||||0.79
71910155|NCT05064332|143341263|OTHER||Ratio of Adjusted Geometric Means|101.43|||||TWO_SIDED|90.0|93.01|110.61||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||110.61|93.01|
71910156|NCT05064332|143341264|OTHER||Ratio of Adjusted Geometric Means|108.51|||||TWO_SIDED|90.0|98.85|119.11||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed AUClast was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||119.11|98.85|
71910157|NCT05064332|143341265|OTHER||Ratio of Adjusted Geometric Means|95.07|||||TWO_SIDED|90.0|84.44|107.04||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||107.04|84.44|
71910158|NCT05064332|143341266|OTHER||Ratio of Adjusted Geometric Means|117.99|||||TWO_SIDED|90.0|101.82|136.73||||||OC alone as the Reference and co-administration of PF-06650833 and OC as the Test. Natural log transformed Cmax was analyzed using a mixed effects model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% CIs were obtained from the model and were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.||136.73|101.82|
71922129|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|95.0|-6.11|1.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||1.60|-6.11|
71910159|NCT00523614|143341277|NON_INFERIORITY_OR_EQUIVALENCE|"Size of the study adapted to the use of DNG/EE in female fertile age. Market share of DNG/EE of 13% in Germany. Assuming that 30% of women in the fertile age range were current users of OCs, a prevalence of current use of DNG/EE of about 4% was estimated.~Based on these data the number of cases needed to exclude a twofold increased VTE risk was estimated at about 500-700 cases (based on four controls per case)."|Odds Ratio (OR)|0.89|||<|0.05||95.0|0.57|1.39|||Regression, Logistic|||Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)||1.39|0.57|<0.05
71910160|NCT02293902|143341278|SUPERIORITY||Odds Ratio (OR)|12.185|||<|0.0001|TWO_SIDED|95.0|5.583|26.594||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 150 mg|26.594|5.583|<0.0001
71910161|NCT02293902|143341278|SUPERIORITY||Odds Ratio (OR)|7.227|||<|0.0001|TWO_SIDED|95.0|3.446|15.158||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (\<55 kg, \>=55 kg).|Placebo vs. Sarilumab 200 mg|15.158|3.446|<0.0001
71910162|NCT01281189|143341312|SUPERIORITY||LS Mean Difference (Final Values)|2.91||||0.8568|TWO_SIDED|95.0|-28.751|34.576|||ANCOVA|Includes treatment as a fixed effect and adjusts for baseline ALSFRS-R total score, duration from sx onset, site of onset, and use of riluzole.||||34.576|-28.751|0.8568
71910163|NCT01281189|143341313|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8375|TWO_SIDED|95.0|0.75|1.427|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole.|||Hazard Ratio (HR) (Dex/PBO)|1.427|0.750|0.8375
71910164|NCT01281189|143341314|SUPERIORITY||LS Mean Difference (Net)|0.076||||0.9019|TWO_SIDED|95.0|-1.128|1.28|||mixed-effects repeated-measures model|Mixed-effects repeated-measures model with treatment, visit, treatment-by visit interaction, baseline ALSFRS-R score, baseline-by-visit interaction|The mixed-effects repeated-measures model also adjusted for the following covariates: duration from symptom onset, site of onset, and use of riluzole.|||1.280|-1.128|0.9019
71910165|NCT01281189|143341315|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7715|TWO_SIDED|95.0|0.801|1.348|||Cox Proportional Hazards model|Adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.348|0.801|0.7715
71910166|NCT01281189|143341316|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9033|TWO_SIDED|95.0|0.745|1.298|||Cox Proportional Hazards model|adjusted for baseline ALSFRS-R total score, duration from symptom onset to the first dose of study treatment, site of onset, and use of riluzole||||1.298|0.745|0.9033
71910167|NCT01281189|143341317|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.772|TWO_SIDED|95.0|0.789|1.192|||Cox Proportional Hazards model||Hazard ratio (Dex/PBO)|||1.192|0.789|0.7720
71910168|NCT05355818|143341318|SUPERIORITY||Diff. in proportion of responders in %|37.9|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian|Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.|There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.|Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
71910169|NCT05355818|143341319|SUPERIORITY||Diff. in proportion of responders in %|36.4|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 12.3% to 59.9%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
71910170|NCT05355818|143341320|SUPERIORITY||Diff. in proportion of responders in %|31.7|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 5.6% to 51.1%.|||||
71910171|NCT05355818|143341321|SUPERIORITY||Diff. in proportion of responders in %|31.2|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 8.7% to 49.4%|||||
71910172|NCT05355818|143341322|SUPERIORITY||Diff. in proportion of responders in %|25.1|||||TWO_SIDED|||||There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \> 0 is used.|Bayesian||There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 3.9% to 42.3%.|Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.||||
71910173|NCT05355818|143341323|SUPERIORITY||Risk Difference (RD)|17.47||||0.0054|TWO_SIDED|95.0|5.16|29.78|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||29.78|5.16|0.0054
71681913|NCT00710684|142881839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.711|TWO_SIDED|95.0|-0.4|0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.3|-0.4|0.711
71910174|NCT05355818|143341324|SUPERIORITY||Risk Difference (RD)|21.21||||0.0248|TWO_SIDED|95.0|2.69|39.72|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||39.72|2.69|0.0248
71910175|NCT05355818|143341325|SUPERIORITY||Risk Difference (RD)|11.08||||0.332|TWO_SIDED|95.0|-11.3|33.46|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||33.46|-11.30|0.3320
71863767|NCT00955708|143241983|OTHER|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|100.0|||||ONE_SIDED|95.0|100.0|||||||The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.|||100|
71863768|NCT01016262|143241984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0047||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between MAX-002 and placebo during the DB phase with respect to the primary outcome measure was the single pre-specified primary analysis, and the null hypothesis was that the percentages were equal between the two groups.||||0.0047
71863769|NCT01016262|143241984|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0346||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between Canasa® and placebo during the DB phase with respect to the primary outcome measure was a pre-specified tertiary analysis only.||||0.0346
71863770|NCT03119233|143241994|OTHER||Lower 97.5% Exact Confidence Limit|68.1|||||ONE_SIDED|97.5|60.9|||||||"The primary effectiveness endpoint is defined as primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR)~≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. The primary effectiveness endpoint hypotheses are:~* H0: 12-month success rate of the PQ Bypass System ≤60.4%~* HA: 12-month success rate of the PQ Bypass System \>60.4%"|||60.9|
71863771|NCT03119233|143241995|OTHER|The rate of freedom from 30-day MAE is expected to be no less than 92%. Based on a PG of 84% and an estimated 30-day freedom from MAE rate of 92% for the PQ Bypass System, a sample size of 169 evaluable subjects provides 88% power to test the primary safety hypothesis at the one-sided alpha level of 0.025. The Exact Test Method and Commercial software PASS14 was used to determine the sample size.|Lower 97.5% Exact Confidence Limit|93.0|||||ONE_SIDED|97.5|88.5|||||||"The primary safety endpoint hypotheses are:~* H0: 30-day Freedom from MAE rate of the PQ Bypass System~  ≤84%~* HA: 30-day Freedom from MAE rate of the PQ Bypass System \>84%"|||88.5|
71863772|NCT02057575|143242002|SUPERIORITY||||||<|0.0001||||||PG324 0.01% vs netarsudil|t-test, 2 sided|||||||<0.0001
71910176|NCT05355818|143341326|SUPERIORITY||Risk Difference (RD)|33.02||||0.0016|TWO_SIDED|95.0|12.51|53.52|||Regression, Logistic||Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.|The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.||53.52|12.51|0.0016
71910177|NCT05355818|143341327|SUPERIORITY||Mean Difference (Net)|-2.65||||0.0038|TWO_SIDED|95.0|-4.42|-0.88|||ANCOVA|||Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).||-0.88|-4.42|0.0038
71910178|NCT00092677|143341339|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.96||||0.591||95.0|0.826|1.115|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.115|0.826|0.591
71910179|NCT00092677|143341340|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.973||||0.732||95.0|0.833|1.137|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.137|0.833|0.732
71910180|NCT00092677|143341341|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.78||||0.024||95.0|0.628|0.967|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.967|0.628|0.024
71863773|NCT02057575|143242002|SUPERIORITY||||||<|0.0001||||||PG324 0.02% vs. netarsudil|t-test, 2 sided|||||||<0.0001
71863774|NCT02057575|143242002|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.01% vs. latanoprost||||||<0.0001
71863775|NCT02057575|143242002|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|PG324 0.02% vs. latanoprost||||||<0.0001
71882511|NCT01505634|143284126|OTHER|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP \<2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|TWO_SIDED|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #2||3.8|-3.7|> 0.999
71882512|NCT01505634|143284127|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.7||||||95.0|-14.3|10.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||10.9|-14.3|
71910181|NCT00092677|143341342|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.829||||0.344||95.0|0.563|1.222|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.222|0.563|0.344
71681914|NCT00710684|142881839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.462|TWO_SIDED|95.0|-0.5|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||0.2|-0.5|0.462
71863776|NCT01735175|143242010|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|The difference between LA-EP2006 and reference pegfilgrastim was 0.07 days (95% CI \[-0.12, 0.26\]). 95% CIs were within the predefined margin of ±1 day confirming equivalence.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
71863777|NCT01735175|143242010|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|TWO_SIDED|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days.|"The hierarchical test procedure aimed to show that~1. LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~2. LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."||0.26|-0.12|0.05
71863778|NCT00755417|143242054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.38||0.0117|TWO_SIDED|97.5|-1.81|-0.11||Based on F test of type III analysis for pairwise comparison at 0.025 level.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4||-0.11|-1.81|0.0117
71863779|NCT00755417|143242054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|97.5|-2.35|-0.66||Based on F test of type III analysis|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4.||-0.66|-2.35|<0.0001
71863780|NCT00755417|143242055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.42||0.183|TWO_SIDED|97.5|-1.49|0.38||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12||0.38|-1.49|0.1830
71863781|NCT00755417|143242055|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.41||0.1975|TWO_SIDED|97.5|-1.46|0.4||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12.||0.40|-1.46|0.1975
71863782|NCT00755417|143242056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.0016|TWO_SIDED|97.5|-0.44|-0.08||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.08|-0.44|0.0016
71863783|NCT00755417|143242056|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.51|-0.14||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.||-0.14|-0.51|<0.0001
71863784|NCT00755417|143242057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0433|TWO_SIDED|97.5|-0.43|0.02||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.02|-0.43|0.0433
71863785|NCT00755417|143242057|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0468|TWO_SIDED|97.5|-0.42|0.03||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.||0.03|-0.42|0.0468
71681915|NCT00710684|142881840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.174|TWO_SIDED|95.0|-5.8|1.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||1.1|-5.8|0.174
71863786|NCT02362503|143242058|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.81|-0.441||Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.|ANCOVA||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||-0.441|-0.810|<0.0001
71863787|NCT02362503|143242059|OTHER||Mean Difference (Net)|45.69|||||TWO_SIDED|95.0|32.95|55.45|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>0.5 log10 c/mL.|||55.45|32.95|
71863788|NCT02362503|143242059|OTHER||Mean Difference (Net)|35.67|||||TWO_SIDED|95.0|24.16|44.25|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for \>1.0 log10 c/mL.|||44.25|24.16|
71863789|NCT02362503|143242065|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-16.8|16.0|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||16.0|-16.8|
71863790|NCT02362503|143242066|OTHER||Mean Difference (Net)|0.617|||||TWO_SIDED|95.0|0.082|1.151|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.|||1.151|0.082|
71863791|NCT03325777|143242119|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.29|=|0.014|TWO_SIDED|95.0|0.14|1.27||a priori threshold is p\<.05|Mixed Models Analysis|Generalized Linear Mixed Models||||1.27|.14|=.014
71863792|NCT03325777|143242120|SUPERIORITY||Mean Difference (Final Values)|172.0|STANDARD_ERROR_OF_MEAN|33.2|<|0.001|TWO_SIDED|95.0|106.0|238.0||a priori threshold for significance was p\<.05|Mixed Models Analysis|||||238|106|<.001
71863793|NCT03004404|143242125|OTHER||Slope|0.748|STANDARD_ERROR_OF_MEAN|0.0743|||TWO_SIDED|95.0|0.5959|0.9001|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1.|In the SRD part of the trial, dose proportionality for AUC0-inf was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.9001|0.5959|
71863794|NCT03004404|143242125|OTHER||Ratio T/R|118.71|STANDARD_ERROR_OF_MEAN|1.11|||TWO_SIDED|90.0|94.57|149.03|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of AUC0-inf for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an Analysis of Variance (ANOVA) model on the logarithmic scale.||149.03|94.57|
71863795|NCT03004404|143242125|OTHER||Geometric mean ratio T1/R (%)|124.79|STANDARD_ERROR_OF_MEAN|1.036|||TWO_SIDED|90.0|116.858|133.255|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Auc0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|133.255|116.858|
71863796|NCT03004404|143242125|OTHER||Geometric mean ratio T2/R (%)|125.17|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|112.89|138.8|||||Standard error of the mean is actually geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of AUC0-inf was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fed (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of AUC0-inf and their two-sided 90% confidence intervals . No hypothesis was tested.|138.80|112.89|
71863797|NCT03004404|143242126|OTHER||Slope|0.7065|STANDARD_ERROR_OF_MEAN|0.0587|||TWO_SIDED|95.0|0.5863|0.8267|||||Standard error of the mean is actually standard error of the slope. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1|In the SRD part of the trial, dose proportionality for Cmax was assessed in the 25 mg to 400 mg dose groups (BI 730357 tablets administered under fasted conditions) using a power model (regression model applied to log-transformed data).||0.8267|0.5863|
71882513|NCT01505634|143284127|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-0.7|||||TWO_SIDED|95.0|-13.4|12.0|||||Relebactam minus Placebo|Percent Diff in Participants with AEs||12.0|-13.4|
71863798|NCT03004404|143242126|OTHER||Ratio T/R|151.22|STANDARD_ERROR_OF_MEAN|1.107|||TWO_SIDED|90.0|122.781|186.248|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet 400mg fed1 (T)/400mg fed2(R), T/R.|Relative bioavailability of the Cmax for the SRD part was performed to test the effect of food intake on the PK of 400 mg BI 730357 tablets. The intra-individual comparison of fed conditions was done using an ANOVA model on the logarithmic scale.||186.248|122.781|
71863799|NCT03004404|143242126|OTHER||Geometric mean ratio T1/R (%)|293.21|STANDARD_ERROR_OF_MEAN|1.069|||TWO_SIDED|90.0|259.044|331.891|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: oral solution in fasted state (test treatment T1)/tablet in fasted state (reference treatment R), T1/R.|Estimation of relative bioavailability of Cmax based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for Oral solution (PfOS) fasted (T1) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|331.891|259.044|
71863800|NCT03004404|143242126|OTHER||Geometric mean ratio T2/R (%)|180.53|STANDARD_ERROR_OF_MEAN|1.059|||TWO_SIDED|90.0|162.369|200.732|||||Standard error of the mean is the geometric standard error of the mean. The geometric mean ratio was calculated as: tablet in fed state (test treatment T2)/tablet in fasted state (reference treatment R), T2/R.|Estimation of relative bioavailability of Cmax was based on ANOVA model on the logarithmic scale, included effects: 'sequence', 'period' and 'treatment' as fixed and 'subjects within sequences' as random|Relative bioavailability of BI 730357 for tablet fasted (T2) vs. tablet fasted (R) was assessed by the point estimators (geometric means) of the intra-subject ratio of Cmax and their two-sided 90% confidence intervals . No hypothesis was tested.|200.732|162.369|
71863801|NCT01937975|143242127|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.87|1.09|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.09|0.87|
71863802|NCT01937975|143242127|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.85|||||TWO_SIDED|90.0|0.58|1.25|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.25|0.58|
71863803|NCT01937975|143242127|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.83|||||TWO_SIDED|90.0|0.56|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.22|0.56|
71863804|NCT01937975|143242127|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.65|||||TWO_SIDED|90.0|1.09|2.49|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.49|1.09|
71863805|NCT01937975|143242128|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.81|1.19|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.19|0.81|
71863806|NCT01937975|143242128|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.54|1.16|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.16|0.54|
71910182|NCT00092677|143341343|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.997||||0.968||95.0|0.842|1.179|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.179|0.842|0.968
71910183|NCT00092677|143341344|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.088||||0.771||95.0|0.617|1.917|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.917|0.617|0.771
71910184|NCT00092677|143341345|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.636||||0.147||95.0|0.345|1.173|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.173|0.345|0.147
71910185|NCT00092677|143341346|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.683||||0.015||95.0|0.503|0.929|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||0.929|0.503|0.015
71910186|NCT00092677|143341347|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.456||||||95.0|0.197|1.057||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.057|0.197|
71863807|NCT01937975|143242128|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.78|||||TWO_SIDED|90.0|0.53|1.14|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.14|0.53|
71863808|NCT01937975|143242128|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.6|||||TWO_SIDED|90.0|1.06|2.42|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.42|1.06|
71863809|NCT01937975|143242129|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|90.0|0.75|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.22|0.75|
71863810|NCT01937975|143242129|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.57|1.48|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.48|0.57|
71863811|NCT01937975|143242129|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.54|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.42|0.54|
71863812|NCT01937975|143242129|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|0.99|2.77|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.77|0.99|
71863813|NCT01937975|143242132|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.92|1.15|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.15|0.92|
71863814|NCT01937975|143242132|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18|||||TWO_SIDED|90.0|0.8|1.73|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.73|0.80|
71863815|NCT01937975|143242132|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|0.82|1.78|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.78|0.82|
71863816|NCT01937975|143242132|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.4|0.92|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.92|0.40|
71910187|NCT00092677|143341348|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.608||||||95.0|0.199|1.86||The p-value was not provided as there were less than 40 patients who reported the specific endpoint.|Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.860|0.199|
71910188|NCT00092677|143341349|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.124||||0.647||95.0|0.682|1.85|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.850|0.682|0.647
71681916|NCT00710684|142881840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.776|TWO_SIDED|95.0|-3.6|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||2.7|-3.6|0.776
71681917|NCT00710684|142881841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.631|TWO_SIDED|95.0|-1.2|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.7|-1.2|0.631
71681918|NCT00710684|142881841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.006|TWO_SIDED|95.0|-2.2|-0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||-0.4|-2.2|0.006
71681919|NCT00710684|142881841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.947|TWO_SIDED|95.0|-1.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||1.2|-1.3|0.947
71681920|NCT00710684|142881841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.5|0.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.0|-2.5|0.057
71681921|NCT00710684|142881841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.925|TWO_SIDED|95.0|-1.6|1.5|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.5|-1.6|0.925
71681922|NCT00710684|142881841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.024|TWO_SIDED|95.0|-3.1|-0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||-0.2|-3.1|0.024
71681923|NCT00710684|142881842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.387|TWO_SIDED|95.0|-0.4|0.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||0.1|-0.4|0.387
71681924|NCT00710684|142881842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.018|TWO_SIDED|95.0|-0.5|-0.1|||MMRM|||SB-742457 35 mg versus placebo at Week 12||-0.1|-0.5|0.018
71681925|NCT00710684|142881842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.439|TWO_SIDED|95.0|-0.3|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||0.6|-0.3|0.439
71681926|NCT00710684|142881842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.336|TWO_SIDED|95.0|-0.6|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||0.2|-0.6|0.336
71681927|NCT00710684|142881842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.8|-0.2|0.190
71681928|NCT00710684|142881842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.787|TWO_SIDED|95.0|-0.5|0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||0.4|-0.5|0.787
71681929|NCT00710684|142881843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.337|TWO_SIDED|95.0|-4.0|1.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||1.4|-4.0|0.337
71863817|NCT01937975|143242133|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.63|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.42|0.63|
71863818|NCT01937975|143242133|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.61|||||TWO_SIDED|90.0|0.39|0.94|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.94|0.39|
71863819|NCT01937975|143242134|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.14|||||TWO_SIDED|90.0|1.08|1.21|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.21|1.08|
71863820|NCT01937975|143242134|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|90.0|0.65|1.14|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.14|0.65|
71863821|NCT01937975|143242134|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.75|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.30|0.75|
71910189|NCT00092677|143341350|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.036||||0.799||95.0|0.788|1.363|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||1.363|0.788|0.799
71863822|NCT01937975|143242134|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.86|||||TWO_SIDED|90.0|1.38|2.51|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.51|1.38|
71922130|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-8.25|1.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.47|-8.25|
71863823|NCT01937975|143242135|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.24|||||TWO_SIDED|90.0|1.17|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.32|1.17|
71863824|NCT01937975|143242135|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.77|||||TWO_SIDED|90.0|0.56|1.06|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.06|0.56|
71863825|NCT01937975|143242135|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.69|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.32|0.69|
71863826|NCT01937975|143242135|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.07|||||TWO_SIDED|90.0|1.46|2.93|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.93|1.46|
71863827|NCT01937975|143242136|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.0|1.26|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||1.26|1.00|
71863828|NCT01937975|143242136|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.84|||||TWO_SIDED|90.0|0.62|1.13|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.13|0.62|
71863829|NCT01937975|143242136|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.7|1.27|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.27|0.70|
71863830|NCT01937975|143242136|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.66|||||TWO_SIDED|90.0|1.21|2.28|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||2.28|1.21|
71863831|NCT01937975|143242139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.88|||||TWO_SIDED|90.0|0.83|0.92|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10||0.92|0.83|
71863832|NCT01937975|143242139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.16|||||TWO_SIDED|90.0|0.88|1.53|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10||1.53|0.88|
71910190|NCT00092677|143341351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.667||||0.052||95.0|0.996|2.791|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.791|0.996|0.052
71910191|NCT00092677|143341352|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.504||||0.008||95.0|1.111|2.035|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo|||2.035|1.111|0.008
71910192|NCT00092677|143341353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.029||0.829||95.0|-0.063|0.051|||ANCOVA|Model terms: treatment and baseline peak transaortic jet velocity|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||0.051|-0.063|0.829
71910193|NCT00092677|143341354|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-32.1|STANDARD_ERROR_OF_MEAN|0.6|<=|0.001||95.0|-33.3|-31.0|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-31.0|-33.3|<=0.001
71910194|NCT00092677|143341355|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-50.0|STANDARD_ERROR_OF_MEAN|0.9|<=|0.001||95.0|-51.8|-48.2|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-48.2|-51.8|<=0.001
71910195|NCT00092677|143341356|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.8|<=|0.001||95.0|2.4|5.5|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||5.5|2.4|<=0.001
71910196|NCT00092677|143341357|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|STANDARD_ERROR_OF_MEAN|1.3|<=|0.001||95.0|-22.6|-17.3|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo|||-17.3|-22.6|<=0.001
71910197|NCT00010803|143341369|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.21|TWO_SIDED|95.0|0.94|1.33|||Log Rank|Time to dementia in Ginkgo vs placebo groups. The Cox proportional hazards model was used to compute hazard ratios and log-rank tests.||The null hypothesis is that the instantaneous hazard rate for Ginkgo biloba and placebo are the same. Assumptions were based on 4%/yr dementia and 6%/yr mortality and dropout combined. A sample size of 3000 with an average follow up of 5 years resulted in 96% power to detecting a 30% reduction in the rate of dementia at a 2-sided significance level of 0.5.||1.33|0.94|0.21
71910198|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.04||||0.7|TWO_SIDED|95.0|0.85|1.27|||Log Rank|||Total Mortality||1.27|0.85|0.70
71910199|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.06||||0.78|TWO_SIDED|95.0|0.7|1.62|||Log Rank|||Atherosclerotic CHD mortality||1.62|0.70|0.78
71910200|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.12||||0.54|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||Incident Myocardial Infarction||1.58|0.79|0.54
71910201|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.84||||0.32|TWO_SIDED|95.0|0.61|1.18|||Log Rank|||Incident Angina||1.18|0.61|0.32
71910202|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.94||||0.66|TWO_SIDED|95.0|0.72|1.23|||Log Rank|||Incident CHD||1.23|0.72|0.66
71910203|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously Provided|Hazard Ratio (HR)|0.91||||0.48|TWO_SIDED|95.0|0.71|1.18|||Log Rank|||Incident CHF||1.18|0.71|0.48
71910204|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.25|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident Stroke||1.45|0.52|0.25
71910205|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|0.87||||0.59|TWO_SIDED|95.0|0.52|1.45|||Log Rank|||Incident TIA||1.45|0.52|0.59
71910206|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Cox Proportional Hazard|1.12||||0.42|TWO_SIDED|95.0|0.84|1.5|||Log Rank|||Incident CVD||1.50|0.84|0.42
71910207|NCT00010803|143341370|NON_INFERIORITY_OR_EQUIVALENCE|Previously provided|Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.8|1.25|||Log Rank|||Total CHD and CVD combined||1.25|0.80|0.98
71910208|NCT00010803|143341371|SUPERIORITY_OR_OTHER||Treatment X Time interaction|-0.002||||0.65|TWO_SIDED|95.0|-0.009|0.005|||Mixed Models Analysis|||Linear mixed models comparing rates of change in global cognition scores (z-scores) by treatment group||0.005|-0.009|.65
71910209|NCT01019252|143341372|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.24|||<|0.0001|TWO_SIDED|95.0|3.28|7.21|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||7.21|3.28|<.0001
71910210|NCT01019252|143341373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.17|||<|0.0001|TWO_SIDED|95.0|0.94|1.39|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||1.39|.94|<.0001
71681930|NCT00710684|142881843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.596|TWO_SIDED|95.0|-1.7|3.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.0|-1.7|0.596
71681931|NCT00710684|142881843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.634|TWO_SIDED|95.0|-4.4|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36||2.7|-4.4|0.634
71681932|NCT00710684|142881843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1||||0.238|TWO_SIDED|95.0|-1.4|5.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||5.6|-1.4|0.238
71681933|NCT00710684|142881843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.292|TWO_SIDED|95.0|-6.0|1.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||1.8|-6.0|0.292
71681934|NCT00710684|142881843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.161|TWO_SIDED|95.0|-1.0|6.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||6.2|-1.0|0.161
71681935|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.396|TWO_SIDED|95.0|-0.8|2.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12||2.1|-0.8|0.396
71681936|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.019|TWO_SIDED|95.0|0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12||3.2|0.3|0.019
71681937|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.11|TWO_SIDED|95.0|-0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||3.2|-0.3|0.110
71681938|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0||||0.024|TWO_SIDED|95.0|0.3|3.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||3.7|0.3|0.024
71681939|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.944|TWO_SIDED|95.0|-2.1|2.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo ate Week 36||2.0|-2.1|0.944
71681940|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.037|TWO_SIDED|95.0|0.1|3.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36||3.8|0.1|0.037
71681941|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.705|TWO_SIDED|95.0|-1.9|2.9|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||2.9|-1.9|0.705
71681942|NCT00710684|142881844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.088|TWO_SIDED|95.0|-0.3|4.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||4.2|-0.3|0.088
71681943|NCT00710684|142881845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.6|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24||0.6|-0.6|0.962
71681944|NCT00710684|142881845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.134|TWO_SIDED|95.0|-0.1|1.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24||1.0|-0.1|0.134
71681945|NCT00710684|142881845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.782|TWO_SIDED|95.0|-1.0|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48||0.7|-1.0|0.782
71681946|NCT00710684|142881845|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.268|TWO_SIDED|95.0|-0.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48||1.2|-0.3|0.268
71681947|NCT02542293|142881893|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0808|TWO_SIDED|95.0|0.485|1.045||The 2-sided p-value was calculated using an unstratified log-rank test.|Log Rank||The HR and confidence interval (CI) were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"Global: Durvalumab + Tremelimumab versus (Vs) Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.045|0.485|0.0808
71681948|NCT02542293|142881894|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.322|1.109|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.109|0.322|
71681949|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.629|1.201|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.201|0.629|
71681950|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.726|1.213|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.213|0.726|
71681951|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.786|1.464|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.464|0.786|
71681952|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.835|1.302|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB \<20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.302|0.835|
71681953|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.758|1.353|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB non-evaluable analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.353|0.758|
71681954|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|0.57|||||TWO_SIDED|95.0|0.309|1.008|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.008|0.309|
71681955|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.56|1.35|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.350|0.560|
71681956|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.614|1.251|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.251|0.614|
71681957|NCT02542293|142881895|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.564|1.08|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.080|0.564|
71681958|NCT02542293|142881896|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.871|1.186|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.186|0.871|
71681959|NCT02542293|142881896|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.48|1.018|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25 and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.018|0.480|
71681960|NCT02542293|142881896|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.654|1.078|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.078|0.654|
71681961|NCT02542293|142881896|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.289|1.065|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.065|0.289|
71681962|NCT02542293|142881896|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.587|1.081|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||1.081|0.587|
71863833|NCT01937975|143242139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.77|1.34|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10||1.34|0.77|
71863834|NCT01937975|143242139|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|90.0|0.4|0.72|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10||0.72|0.40|
71863835|NCT01937975|143242140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95|||||TWO_SIDED|90.0|0.7|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|||1.30|0.70|
71863836|NCT01937975|143242140|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.63|||||TWO_SIDED|90.0|0.45|0.89|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|||0.89|0.45|
71863837|NCT01266161|143242149|SUPERIORITY||Mean Difference (Final Values)|23.76|||<|0.001|TWO_SIDED|95.0|16.45|31.07||p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||31.07|16.45|<0.001
71863838|NCT01266161|143242150|SUPERIORITY||Mean Difference (Final Values)|8.42|||<|0.001|TWO_SIDED|95.0|4.13|12.71||p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA|||||12.71|4.13|<0.001
71863839|NCT01266161|143242151|SUPERIORITY||Least-squares means|8.95|||<|0.001|TWO_SIDED|95.0|5.94|11.95||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-12.||11.95|5.94|<0.001
71863840|NCT01266161|143242151|SUPERIORITY||Least-squares means|3.15|||<|0.001|TWO_SIDED|95.0|1.45|4.85||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 8-12.||4.85|1.45|<0.001
71863841|NCT01266161|143242151|SUPERIORITY||Least-squares means|6.56|||<|0.001|TWO_SIDED|95.0|2.84|10.27||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 12-24.||10.27|2.84|<0.001
71863842|NCT01266161|143242151|SUPERIORITY||Least-squares means|2.02||||0.091|TWO_SIDED|95.0|-0.33|4.37||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 20-24.||4.37|-0.33|0.091
71863843|NCT01266161|143242151|SUPERIORITY||Least-squares means|14.95|||<|0.001|TWO_SIDED|95.0|9.12|20.79||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-24.||20.79|9.12|<0.001
71863844|NCT01266161|143242151|SUPERIORITY||Least-squares means|5.87||||0.01|TWO_SIDED|95.0|1.42|10.33||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-36.||10.33|1.42|0.010
71910211|NCT01019252|143341374|SUPERIORITY||Mean Difference (Net)|10.93|||<|0.0001|TWO_SIDED|95.0|8.93|12.93|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.||||12.93|8.93|<.0001
71922131|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|2.31|||TWO_SIDED|95.0|-6.4|3.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.18|-6.40|
71863845|NCT01266161|143242151|SUPERIORITY||Least-squares means|3.48||||0.004|TWO_SIDED|95.0|1.13|5.83||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 32-36.||5.83|1.13|0.004
71863846|NCT01266161|143242151|SUPERIORITY||Least-squares means|6.09||||0.006|TWO_SIDED|95.0|1.82|10.36||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 36-48.||10.36|1.82|0.006
71863847|NCT01266161|143242151|SUPERIORITY||Least-squares means|2.41||||0.042|TWO_SIDED|95.0|0.09|4.73||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 44-48.||4.73|0.09|0.042
71863848|NCT01266161|143242151|SUPERIORITY||Least-squares means|10.97||||0.004|TWO_SIDED|95.0|3.49|18.45||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-48.||18.45|3.49|0.004
71863849|NCT01266161|143242152|SUPERIORITY||Hazard Ratio (HR)|0.18|||<|0.001||95.0|0.1|0.34|||proportional hazards model|||||0.34|0.10|<0.001
71863850|NCT01266161|143242153|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.46|-31.56||p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the first dosing interval (0 to 12 hours).||-31.56|-64.46|<0.001
71863851|NCT01266161|143242153|SUPERIORITY||Treatment Difference|-25.53|||<|0.001||95.0|-39.78|-11.28||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the second dosing interval (12 to 24 hours).||-11.28|-39.78|<0.001
71863852|NCT01266161|143242153|SUPERIORITY||Treatment Difference|-24.05||||0.002||95.0|-38.93|-9.18||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the third dosing interval (24 to 36 hours).||-9.18|-38.93|0.002
71863853|NCT01266161|143242153|SUPERIORITY||Treatment Difference|-13.6||||0.035||95.0|-26.41|-0.79||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the fourth dosing interval (36 to 48 hours).||-0.79|-26.41|0.035
71863854|NCT01266161|143242153|SUPERIORITY||Treatment Difference|-48.01|||<|0.001||95.0|-64.42|-31.6||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the study overall (0 to 48 hours).||-31.60|-64.42|<0.001
71863855|NCT01266161|143242153|SUPERIORITY||Cox proportional hazard models|0.086||||0.011|TWO_SIDED|95.0|0.01|0.57|||Andersen-Gill (AG)|||Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)||0.57|0.01|0.011
71863856|NCT01266161|143242154|SUPERIORITY||Least squares means|0.84|||<|0.001||95.0|0.5|1.19||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.19|0.50|<0.001
71863857|NCT01266161|143242154|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|1.11|1.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.94|1.11|<0.001
71863858|NCT01266161|143242154|SUPERIORITY||Least squares means|2.0|||<|0.001||95.0|1.56|2.44||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||2.44|1.56|<0.001
71863859|NCT01266161|143242154|SUPERIORITY||Least squares means|2.29|||<|0.001||95.0|1.86|2.73||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||2.73|1.86|<0.001
71863860|NCT01266161|143242154|SUPERIORITY||Least squares means|2.18|||<|0.001||95.0|1.69|2.68||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||2.68|1.69|<0.001
71863861|NCT01266161|143242154|SUPERIORITY||Least squares means|0.92|||<|0.001||95.0|0.46|1.38||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.|Ibuprofen versus placebo at 6 hours.||1.38|0.46|<0.001
71863862|NCT01266161|143242154|SUPERIORITY||Least squares means|1.04|||<|0.001||95.0|0.54|1.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||1.54|0.54|<0.001
71863863|NCT01266161|143242154|SUPERIORITY||Least squares means|1.1|||<|0.001||95.0|0.59|1.6||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||1.60|0.59|<0.001
71863864|NCT01266161|143242154|SUPERIORITY||Least squares means|0.5||||0.052||95.0|0.0|1.01||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.01|-0.00|0.052
71863865|NCT01266161|143242155|SUPERIORITY||Least squares means|0.37|||<|0.001||95.0|0.16|0.59||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||0.59|0.16|<0.001
71863866|NCT01266161|143242155|SUPERIORITY||Least squares means|0.9|||<|0.001||95.0|0.63|1.18||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||1.18|0.63|<0.001
71863867|NCT01266161|143242155|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.91|1.52||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||1.52|0.91|<0.001
71863868|NCT01266161|143242155|SUPERIORITY||Least squares means|1.4|||<|0.001||95.0|1.1|1.71||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||1.71|1.10|<0.001
71863869|NCT01266161|143242155|SUPERIORITY||Least squares means|1.32|||<|0.001||95.0|0.97|1.67||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||1.67|0.97|<0.001
71863870|NCT01266161|143242155|SUPERIORITY||Least squares means|0.61|||<|0.001||95.0|0.3|0.91||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||0.91|0.30|<0.001
71863871|NCT01266161|143242155|SUPERIORITY||Least squares means|0.64|||<|0.001||95.0|0.31|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||0.97|0.31|<0.001
71863872|NCT01266161|143242155|SUPERIORITY||Least squares means|0.66|||<|0.001||95.0|0.36|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||0.97|0.36|<0.001
71863873|NCT01266161|143242155|SUPERIORITY||Least squares means|0.27||||0.089||95.0|-0.04|0.59||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||0.59|-0.04|0.089
71910212|NCT03351478|143341384|SUPERIORITY||Difference in Least Square (LS) Means|-0.43|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.62|-0.25|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||-0.25|-0.62|< 0.0001
71910213|NCT03351478|143341384|SUPERIORITY||Difference in LS Means|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.145|TWO_SIDED|95.0|-0.04|0.28|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline HbA1c as a covariate.||0.28|-0.04|0.145
71910214|NCT03351478|143341385|SUPERIORITY||Difference in LS Means|-2.05|STANDARD_ERROR_OF_MEAN|1.43||0.1529|TWO_SIDED|95.0|-4.87|0.76|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||0.76|-4.87|0.1529
71910215|NCT03351478|143341385|SUPERIORITY||Difference in LS Means|1.17|STANDARD_ERROR_OF_MEAN|1.21||0.3377|TWO_SIDED|95.0|-1.21|3.55|||ANCOVA|||The change from baseline to Week 12 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||3.55|-1.21|0.3377
71910216|NCT03351478|143341386|SUPERIORITY||Difference in LS Means|-0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.33|-0.5|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||-0.5|-1.33|<0.0001
71910217|NCT03351478|143341386|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.17||0.8397|TWO_SIDED|95.0|-0.37|0.3|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥ 130 mmHg) at screening, and the country as fixed effects, and baseline 2-hour postprandial glucose as a covariate.||0.3|-0.37|0.8397
71922132|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-2.5|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|95.0|-6.9|1.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.90|-6.90|
71863874|NCT01266161|143242155|SUPERIORITY||Least squares means|1.0|||<|0.001||95.0|0.7|1.29||Ibuprofen versus placebo at 0.5 hours.|ANOVA|||Ibuprofen versus placebo at 16 hours.||1.29|0.70|<0.001
71863875|NCT01266161|143242155|SUPERIORITY||Least squares means|0.47||||0.004||95.0|0.15|0.78||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 20 hours.||0.78|0.15|0.004
71863876|NCT01266161|143242155|SUPERIORITY||Least squares means|0.04||||0.821||95.0|-0.28|0.35||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 24 hours.||0.35|-0.28|0.821
71863877|NCT01266161|143242155|SUPERIORITY||Least squares means|0.56||||0.001||95.0|0.23|0.9||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 28 hours.||0.90|0.23|0.001
71681963|NCT02542293|142881896|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.222|0.955|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC."||0.955|0.222|
71681964|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.514|1.146|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.146|0.514|
71863878|NCT01266161|143242155|SUPERIORITY||Least squares means|0.62|||<|0.001||95.0|0.3|0.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 32 hours.||0.94|0.30|<0.001
71863879|NCT01266161|143242155|SUPERIORITY||Least squares means|0.25||||0.127||95.0|-0.07|0.57||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 36 hours.||0.57|-0.07|0.127
71863880|NCT01266161|143242155|SUPERIORITY||Least squares means|0.67|||<|0.001||95.0|0.35|1.0||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 40 hours.||1.00|0.35|<0.001
71863881|NCT01266161|143242155|SUPERIORITY||Least squares means|0.34||||0.036||95.0|0.02|0.67||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 44 hours.||0.67|0.02|0.036
71910218|NCT03351478|143341387|SUPERIORITY||Difference in LS Means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0005|TWO_SIDED|95.0|-1.25|-0.35|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||-0.35|-1.25|0.0005
71910219|NCT03351478|143341387|SUPERIORITY||Difference in LS Means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1339|TWO_SIDED|95.0|-0.09|0.7|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline fasting plasma glucose as a covariate.||0.7|-0.09|0.1339
71681965|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.623|1.189|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.189|0.623|
71681966|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.714|1.193|||||The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.193|0.714|
71681967|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.258|0.818|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||0.818|0.258|
71681968|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.524|1.228|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.228|0.524|
71681969|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.585|1.177|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.177|0.585|
71681970|NCT02542293|142881897|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.534|1.017|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.017|0.534|
71863882|NCT01266161|143242155|SUPERIORITY||Least squares means|0.26||||0.091||95.0|-0.04|0.56||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 48 hours.||0.56|-0.04|0.091
71863883|NCT01266161|143242156|SUPERIORITY||Least squares means|1.22|||<|0.001||95.0|0.69|1.74||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.||1.74|0.69|<0.001
71863884|NCT01266161|143242156|SUPERIORITY||Least squares means|2.43|||<|0.001||95.0|1.77|3.09||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.||3.09|1.77|<0.001
71863885|NCT01266161|143242156|SUPERIORITY||Least squares means|3.22|||<|0.001||95.0|2.49|3.95||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.||3.95|2.49|<0.001
71863886|NCT01266161|143242156|SUPERIORITY||Least squares means|3.7|||<|0.001||95.0|2.98|4.42||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.||4.42|2.98|<0.001
71863887|NCT01266161|143242156|SUPERIORITY||Least squares means|3.5|||<|0.001||95.0|2.67|4.33||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.||4.33|2.67|<0.001
71863888|NCT01266161|143242156|SUPERIORITY||Least squares means|1.53|||<|0.001||95.0|0.79|2.27||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.||2.27|0.79|<0.001
71863889|NCT01266161|143242156|SUPERIORITY||Least squares means|1.67|||<|0.001||95.0|0.87|2.48||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.||2.48|0.87|<0.001
71863890|NCT01266161|143242156|SUPERIORITY||Least squares means|1.76|||<|0.001||95.0|0.97|2.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.||2.54|0.97|<0.001
71863891|NCT01266161|143242156|SUPERIORITY||Least squares means|0.78||||0.056||95.0|-0.02|1.58||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.||1.58|-0.02|0.056
71863892|NCT01266161|143242157|SUPERIORITY||Least squares means|14.82|||<|0.001|TWO_SIDED|95.0|10.38|19.25||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0 to 12 hours.||19.25|10.38|<0.001
71863893|NCT01266161|143242157|SUPERIORITY||Least squares means|5.27|||<|0.001|TWO_SIDED|95.0|2.57|7.98||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo from 8 to 12 hours.||7.98|2.57|<0.001
71863894|NCT01266161|143242158|SUPERIORITY||CMH-adjusted proportion|-0.73|||<|0.001|TWO_SIDED|95.0|-0.91|-0.55||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the first dosing interval.||-0.55|-0.91|<0.001
71863895|NCT01266161|143242158|SUPERIORITY||CMH-adjusted proportions|-0.72|||<|0.001|TWO_SIDED|95.0|-1.05|-0.4||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.|Cochran-Mantel-Haenszel|||For the second dosing interval.||-0.40|-1.05|<0.001
71863896|NCT01266161|143242158|SUPERIORITY||CMH-adjusted proportions|-0.48||||0.002|TWO_SIDED|95.0|-0.9|-0.06||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the third dosing interval.||-0.06|-0.90|0.002
71863897|NCT01266161|143242158|SUPERIORITY||CMH-adjusted proportion|-0.68||||0.021|TWO_SIDED|95.0|-1.02|-0.35||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the fourth dosing interval.||-0.35|-1.02|0.021
71863898|NCT01266161|143242158|SUPERIORITY||CMH-adjusted proportion|-0.7|||<|0.001|TWO_SIDED|95.0|-0.89|-0.51||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the overall study duration.||-0.51|-0.89|<0.001
71863899|NCT01266161|143242161|SUPERIORITY||Gamma statistic|0.85|||<|0.001|TWO_SIDED|95.0|0.74|0.95||p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.|Cochran-Mantel-Haenszel|||Ibuprofen versus placebo at 24 hours||0.95|0.74|<0.001
71863900|NCT01266161|143242161|SUPERIORITY||Gamma statistic|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.92|||Cochran-Mantel-Haenszel|p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.||Ibuprofen versus placebo at 48 hours||0.92|0.66|<0.001
71863901|NCT02567708|143242201|OTHER||Posterior median difference.|0.007|STANDARD_DEVIATION|0.0468||0.57|TWO_SIDED|95.0|-0.083|0.102||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.102|-0.083|0.57
71863902|NCT02567708|143242202|OTHER||Posterior median difference.|0.013|STANDARD_DEVIATION|0.0501||0.61|TWO_SIDED|95.0|-0.084|0.113||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.113|-0.084|0.61
71863903|NCT02567708|143242203|OTHER|The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Posterior median difference|0.05|STANDARD_DEVIATION|0.0818||0.731|TWO_SIDED|95.0|-0.111|0.21|||Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.210|-0.111|0.731
71863904|NCT02567708|143242204|OTHER||Posterior median difference|-0.009|STANDARD_DEVIATION|0.0712||0.44|TWO_SIDED|95.0|-0.151|0.131||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.131|-0.151|0.44
71882514|NCT01505634|143284128|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-5.8|5.9|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||5.9|-5.8|
71882515|NCT01505634|143284128|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-7.6|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs||2.8|-7.6|
71882516|NCT01505634|143284129|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-7.5|9.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||9.8|-7.5|
71882517|NCT01505634|143284129|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.1|||||TWO_SIDED|95.0|-8.4|8.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs||8.6|-8.4|
71863905|NCT02567708|143242204|OTHER||Posterior median difference|0.024|STANDARD_DEVIATION|0.057||0.66|TWO_SIDED|95.0|-0.087|0.137||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.137|-0.087|0.66
71863906|NCT02567708|143242205|OTHER||Posterior median difference|-0.021|STANDARD_DEVIATION|0.0609||0.35|TWO_SIDED|95.0|-0.14|0.099||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.099|-0.140|0.35
71863907|NCT02567708|143242205|OTHER||Posterior median difference|0.04|STANDARD_DEVIATION|0.0578||0.76|TWO_SIDED|95.0|-0.071|0.156||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.156|-0.071|0.76
71863908|NCT02567708|143242205|OTHER||Posterior median difference|0.038|STANDARD_DEVIATION|0.0559||0.76|TWO_SIDED|95.0|-0.073|0.148||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||0.148|-0.073|0.76
71863909|NCT02567708|143242206|OTHER||Posterior median difference|0.083|STANDARD_DEVIATION|0.6175||0.56|TWO_SIDED|95.0|-1.102|1.346||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.346|-1.102|0.56
71863910|NCT02567708|143242206|OTHER||Posterior median difference|0.014|STANDARD_DEVIATION|0.6672||0.51|TWO_SIDED|95.0|-1.271|1.341||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.341|-1.271|0.51
71863911|NCT02567708|143242206|OTHER||Posterior median difference|-0.113|STANDARD_DEVIATION|0.5148||0.41|TWO_SIDED|95.0|-1.125|0.908||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo..|||0.908|-1.125|0.41
71863912|NCT02567708|143242207|OTHER||Posterior median difference|0.5|STANDARD_DEVIATION|0.59||0.81|TWO_SIDED|95.0|-0.6|1.7||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.|||1.7|-0.6|0.81
71863913|NCT02567708|143242210|OTHER||Posterior median ratio|0.89|STANDARD_DEVIATION|0.063||0.97|TWO_SIDED|95.0|0.78|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.00|0.78|0.97
71863914|NCT02567708|143242210|OTHER||Posterior median ratio|0.95|STANDARD_DEVIATION|0.071||0.76|TWO_SIDED|95.0|0.83|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.09|0.83|0.76
71863915|NCT02567708|143242210|OTHER||Posterior median ratio|1.0|STANDARD_DEVIATION|0.085||0.51|TWO_SIDED|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than one.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.|||1.18|0.84|0.51
71863916|NCT05262751|143242228|OTHER||gMean Ratio|16.69|||||TWO_SIDED|90.0|7.28|38.24|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.24|7.28|
71863917|NCT05262751|143242228|OTHER||gMean Ratio|13.54|||||TWO_SIDED|90.0|8.1|22.64|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 34.1|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||22.64|8.10|
71922133|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-4.96|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|95.0|-11.22|1.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.31|-11.22|
71863918|NCT05262751|143242228|OTHER||gMean Ratio|41.8|||||TWO_SIDED|90.0|34.24|51.04|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||51.04|34.24|
71863919|NCT05262751|143242228|OTHER||gMean Ratio|42.91|||||TWO_SIDED|90.0|34.9|52.76|||||gMean Ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 28.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||52.76|34.90|
71863920|NCT05262751|143242229|OTHER||gMean Ratio|9.36|||||TWO_SIDED|90.0|5.91|14.8|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||14.80|5.91|
71863921|NCT05262751|143242229|OTHER||gMean Ratio|12.41|||||TWO_SIDED|90.0|7.93|19.43|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 44.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||19.43|7.93|
71863922|NCT05262751|143242229|OTHER||gMean Ratio|37.9|||||TWO_SIDED|90.0|29.25|49.11|||||gMean Ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||49.11|29.25|
71863923|NCT05262751|143242229|OTHER||gMean Ratio|35.89|||||TWO_SIDED|90.0|27.66|46.55|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 40.4|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||46.55|27.66|
71863924|NCT05262751|143242230|OTHER||gMean Ratio|12.09|||||TWO_SIDED|90.0|6.73|21.71|||||gMean Ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||21.71|6.73|
71863925|NCT05262751|143242230|OTHER||gMean Ratio|23.94|||||TWO_SIDED|90.0|13.51|42.42|||||gMean Ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 58.8|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||42.42|13.51|
71863926|NCT05262751|143242230|OTHER||gMean Ratio|68.55|||||TWO_SIDED|90.0|50.07|93.86|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||93.86|50.07|
71863927|NCT05262751|143242230|OTHER||gMean Ratio|66.85|||||TWO_SIDED|90.0|48.77|91.64|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 50.0|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||91.64|48.77|
71863928|NCT05262751|143242231|OTHER||gMean Ratio|11.96|||||TWO_SIDED|90.0|8.88|16.11|||||gMean ratio: MR1-1/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||16.11|8.88|
71863929|NCT05262751|143242231|OTHER||gMean Ratio|13.98|||||TWO_SIDED|90.0|10.59|18.46|||||gMean ratio: MR1-2/R. Intra-individual Geometric coefficient of variation \[%\] = 23.5|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||18.46|10.59|
71863930|NCT05262751|143242231|OTHER||gMean Ratio|32.13|||||TWO_SIDED|90.0|26.46|39.01|||||gMean ratio: MR2-1/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||39.01|26.46|
71863931|NCT05262751|143242231|OTHER||gMean Ratio|31.38|||||TWO_SIDED|90.0|25.71|38.3|||||gMean ratio: MR2-2/R. Intra-individual Geometric coefficient of variation \[%\] = 29.3.|Analysis of Variance (ANOVA) model (logarithmic scale) with the effects: sequence, subjects within sequences, period, and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||38.30|25.71|
71863932|NCT01154140|143242232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.454|||<|0.0001|TWO_SIDED|95.0|0.346|0.596||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group performance status (ECOG PS),race,brain metastases. 1-sided log-rank test at 0.0247 level of significance was used to compare PFS between the 2 arms.|Log Rank|||||0.596|0.346|<0.0001
71863933|NCT01154140|143242233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.0489|TWO_SIDED|95.0|0.548|1.053||P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.|Log Rank||HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.|||1.053|0.548|0.0489
71863934|NCT01154140|143242235|SUPERIORITY_OR_OTHER||Difference in Percentage|29.4|||<|0.0001|TWO_SIDED|95.0|19.5|39.3||P-value was obtained from a Pearson chi-square test.|Pearson chi-square test||95% CI was calculated based on normal distribution.|If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)\<= 0.0494.||39.3|19.5|<0.0001
71863935|NCT01154140|143242238|SUPERIORITY_OR_OTHER||Difference in Percentage|10.067||||0.0381|TWO_SIDED|95.0|0.8|19.4|||Pearson chi-square test|||The confidence interval for the difference in percentage was based on normal distribution.||19.4|0.8|0.0381
71863936|NCT01154140|143242239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.335|0.582||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR \<1 indicated a reduction in hazard rate in favor of Crizotinib.||0.582|0.335|<0.0001
71863937|NCT01154140|143242240|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.595||||0.0347|TWO_SIDED|95.0|0.338|1.048||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||1.048|0.338|0.0347
71863938|NCT01154140|143242241|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.387|||<|0.0001|TWO_SIDED|95.0|0.286|0.524||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.||0.524|0.286|<0.0001
71863939|NCT01154140|143242248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.591||||0.0002|TWO_SIDED|95.0|0.452|0.773||Two-sided p-value from the unstratified log rank test was used.|Log Rank|||HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.||0.773|0.452|0.0002
71863940|NCT01154140|143242249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.8303|||<|0.0001|TWO_SIDED|95.0|10.74|16.92|||Mixed Models Analysis|||QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.92|10.74|<0.0001
71863941|NCT01154140|143242249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3532||||0.017|TWO_SIDED|95.0|0.6|6.11|||Mixed Models Analysis|||QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||6.11|0.60|0.0170
71863942|NCT01154140|143242249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.5165|||<|0.0001|TWO_SIDED|95.0|4.57|10.46|||Mixed Models Analysis|||QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||10.46|4.57|<0.0001
71863943|NCT01154140|143242249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.4035|||<|0.0001|TWO_SIDED|95.0|7.48|13.32|||Mixed Models Analysis|||QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||13.32|7.48|<0.0001
71863944|NCT01154140|143242249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|15.5513|||<|0.0001|TWO_SIDED|95.0|11.29|19.81|||Mixed Models Analysis|||QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||19.81|11.29|<0.0001
71863945|NCT01154140|143242249|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7641|||<|0.0001|TWO_SIDED|95.0|4.69|12.84|||Mixed Models Analysis|||QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||12.84|4.69|<0.0001
71863946|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.4976|||<|0.0001|TWO_SIDED|95.0|-18.03|-8.97|||Mixed Models Analysis|||QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-8.97|-18.03|<0.0001
71863947|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.4336||||0.057|TWO_SIDED|95.0|-9.0|0.13|||Mixed Models Analysis|||QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||0.13|-9.00|0.0570
71863948|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.4906|||<|0.0001|TWO_SIDED|95.0|8.98|16.0|||Mixed Models Analysis|||QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||16.00|8.98|<0.0001
71863949|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Median Difference (Net)|-13.4622|||<|0.0001|TWO_SIDED|95.0|-17.2|-9.73|||Mixed Models Analysis|||QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-9.73|-17.20|<0.0001
71863950|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.9987|||<|0.0001|TWO_SIDED|95.0|-18.52|-11.48|||Mixed Models Analysis|||QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-11.48|-18.52|<0.0001
71863951|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8186||||0.6681|TWO_SIDED|95.0|-4.56|2.92|||Mixed Models Analysis|||QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||2.92|-4.56|0.6681
71910220|NCT03351478|143341388|SUPERIORITY||Difference in LS Means|-2.25|STANDARD_ERROR_OF_MEAN|0.36|<|0.0001|TWO_SIDED|95.0|-2.95|-1.54|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||-1.54|-2.95|<0.0001
71863952|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.043|||<|0.0001|TWO_SIDED|95.0|-14.22|-5.87|||Mixed Models Analysis|||QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-5.87|-14.22|<0.0001
71863953|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4446||||0.0468|TWO_SIDED|95.0|-6.84|-0.05|||Mixed Models Analysis|||QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-0.05|-6.84|0.0468
71863954|NCT01154140|143242250|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.9277|||<|0.0001|TWO_SIDED|95.0|-13.23|-6.62|||Mixed Models Analysis|||QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).||-6.62|-13.23|<0.0001
71863955|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.8149||||0.0108|TWO_SIDED|95.0|-8.52|-1.11|||Mixed Models Analysis|||QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-1.11|-8.52|0.0108
71863956|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.3926|||<|0.0001|TWO_SIDED|95.0|-12.06|-4.72|||Mixed Models Analysis|||QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.72|-12.06|<0.0001
71863957|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6651||||0.5938|TWO_SIDED|95.0|-1.78|3.11|||Mixed Models Analysis|||QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||3.11|-1.78|0.5938
71863958|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.008|||<|0.0001|TWO_SIDED|95.0|-11.96|-6.06|||Mixed Models Analysis|||QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-6.06|-11.96|<0.0001
71863959|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8828||||0.0656|TWO_SIDED|95.0|-1.82|0.06|||Mixed Models Analysis|||QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.06|-1.82|0.0656
71863960|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.0475||||0.0002|TWO_SIDED|95.0|-9.22|-2.88|||Mixed Models Analysis|||QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-2.88|-9.22|0.0002
71863961|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0959|||<|0.0001|TWO_SIDED|95.0|-11.35|-4.84|||Mixed Models Analysis|||QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-4.84|-11.35|<0.0001
71863962|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7717||||0.0001|TWO_SIDED|95.0|-10.24|-3.31|||Mixed Models Analysis|||QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||-3.31|-10.24|0.0001
71863963|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3521||||0.0427|TWO_SIDED|95.0|0.11|6.59|||Mixed Models Analysis|||QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||6.59|0.11|0.0427
71863964|NCT01154140|143242251|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1521||||0.1382|TWO_SIDED|95.0|-5.0|0.69|||Mixed Models Analysis|||QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).||0.69|-5.00|0.1382
71863965|NCT01154140|143242252|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.9908||||0.0139|TWO_SIDED|95.0|0.81|7.17|||Mixed Models Analysis|||Analysis was based on a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EQ-5D VAS subscale baseline score (intercept and time from first dose were included as random effects).||7.17|0.81|0.0139
71863966|NCT00478192|143242256|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.028
71863967|NCT00478192|143242256|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||0.019
71863968|NCT00478192|143242256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."||||<0.001
71922134|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-4.5|STANDARD_ERROR_OF_MEAN|2.84|||TWO_SIDED|95.0|-10.41|1.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.40|-10.41|
71863969|NCT00478192|143242261|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||ANCOVA|||||||0.079
71863970|NCT00664534|143242276|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm|Least squares mean difference|-0.14|||||TWO_SIDED|95.0|-0.42|0.13|||||Least squares mean difference = (Premix insulin Lispro -Glargine)|||0.13|-0.42|
71863971|NCT00664534|143242278|SUPERIORITY_OR_OTHER||Least squares mean difference|0.05|||||TWO_SIDED|95.0|-0.18|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks|||0.29|-0.18|
71863972|NCT00664534|143242278|SUPERIORITY_OR_OTHER||Least squares mean difference|0.04|||||TWO_SIDED|95.0|-0.22|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks|||0.29|-0.22|
71863973|NCT00664534|143242278|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.08|||||TWO_SIDED|95.0|-0.33|0.18|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks|||0.18|-0.33|
71863974|NCT00664534|143242279|SUPERIORITY_OR_OTHER|||||||0.2127||95.0||||P-value is for Week 16 HbA1c \<=7.0%.|Chi-squared|||||||0.2127
71863975|NCT00664534|143242279|SUPERIORITY_OR_OTHER|||||||0.3281||95.0||||P-value is for Week 16 HbA1c \<=6.5%|Chi-squared|||||||0.3281
71863976|NCT00664534|143242279|SUPERIORITY_OR_OTHER|||||||0.2812||95.0||||P-value is for Week 32 HbA1c \<=7.0%|Chi-squared|||||||0.2812
71863977|NCT00664534|143242279|SUPERIORITY_OR_OTHER|||||||0.6963||95.0||||P-value is for Week 32 HbA1c \<=6.5%|Chi-squared|||||||0.6963
71863978|NCT00664534|143242279|SUPERIORITY_OR_OTHER|||||||0.0643||95.0||||P-value is for Week 48 HbA1c \<=7.0%|Chi-squared|||||||0.0643
71863979|NCT00664534|143242279|SUPERIORITY_OR_OTHER|||||||0.2524||95.0||||P-value is for Week 48 HbA1c \<=6.5%|Chi-squared|||||||0.2524
71863980|NCT00664534|143242281|SUPERIORITY_OR_OTHER|||||||0.6615||95.0||||P-value for Baseline|Wilcoxon (Mann-Whitney)|||||||0.6615
71863981|NCT00664534|143242281|SUPERIORITY_OR_OTHER|||||||0.9798||95.0||||P-value is for Week 16|Wilcoxon (Mann-Whitney)|||||||0.9798
71863982|NCT00664534|143242281|SUPERIORITY_OR_OTHER|||||||0.6169||95.0||||P-value for Week 32|Wilcoxon (Mann-Whitney)|||||||0.6169
71863983|NCT00664534|143242281|SUPERIORITY_OR_OTHER|||||||0.7834||95.0||||P-value for Week 48|Wilcoxon (Mann-Whitney)|||||||0.7834
71863984|NCT00664534|143242283|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|-0.89|0.7|||||Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.|||0.70|-0.89|
71863985|NCT00664534|143242284|SUPERIORITY_OR_OTHER|||||||0.4935||95.0|||||Fisher Exact|||||||0.4935
71863986|NCT00630734|143242307|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||Threshold of significance was P\<0.05.|ANOVA|||Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).||||0.43
71863987|NCT00630734|143242308|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||ANOVA|||||||0.28
71863988|NCT00630734|143242309|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||ANOVA|||||||0.66
71863989|NCT00630734|143242310|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||ANOVA|||||||0.85
71863990|NCT00630734|143242311|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||ANOVA|||||||0.11
71863991|NCT00630734|143242312|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||ANOVA|||||||0.15
71863992|NCT00630734|143242313|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||ANOVA|||||||0.22
71863993|NCT00630734|143242314|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||ANOVA|||||||0.67
71863994|NCT00630734|143242315|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||||||0.006
71863995|NCT00630734|143242316|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||||||0.08
71863996|NCT06152224|143242317|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|4.0||0.918|TWO_SIDED|||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.918
71863997|NCT06152224|143242322|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.801||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.801
71863998|NCT06152224|143242322|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.317||||||a priori threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline||||0.317
71863999|NCT06152224|143242323|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline Brink Score: Pressure||||<0.001
71864000|NCT06152224|143242323|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Pressure||||<0.001
71864001|NCT06152224|143242324|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Change from baseline in Brink Score: Vertical Displacement||||<0.001
71864002|NCT06152224|143242324|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Vertical Displacement||||<0.001
71864003|NCT06152224|143242325|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
71864004|NCT06152224|143242325|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.|||||<|0.001||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||change from baseline in Brink Score: Duration Contraction||||<0.001
71864005|NCT06152224|143242335|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.035||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q1. The app was easy to use||||0.035
71864006|NCT06152224|143242335|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.063||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q2. It was easy for me to learn to use the app||||0.063
71864007|NCT06152224|143242335|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.587||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q11. I would use this app again||||0.587
71864008|NCT06152224|143242335|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.107||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q12. Overall, I am satisfied with this app||||0.107
71864009|NCT06152224|143242335|EQUIVALENCE|Power analysis was determined based on a 3 point improvement on the Vaizey score in both groups. With an allowable difference of 1 point between randomized groups, type I error level = 0.05, power = 0.8, and standard deviation of outcome of 4.||||||0.486||||||a prior threshold 0.05|t-test, 2 sided|continuous outcome||Q15. The app helped me manage my health effectively||||0.486
71864010|NCT05239598|143242442|SUPERIORITY||Mean Difference (Net)|4.5||||0.287|TWO_SIDED|95.0|-4.0|13.0|||t-test, 2 sided|||||13.0|-4.0|0.287
71910221|NCT03351478|143341388|SUPERIORITY||Difference in LS Means|0.51|STANDARD_ERROR_OF_MEAN|0.34||0.1407|TWO_SIDED|95.0|-0.17|1.19|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and the country as fixed effects, and baseline weight as a covariate.||1.19|-0.17|0.1407
71910222|NCT03351478|143341389|SUPERIORITY||Difference in LS Means|-2.03|STANDARD_ERROR_OF_MEAN|0.95||0.0325|TWO_SIDED|95.0|-3.89|-0.17|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||-0.17|-3.89|0.0325
71910223|NCT03351478|143341389|SUPERIORITY||Difference in LS Means|1.1|STANDARD_ERROR_OF_MEAN|0.78||0.1565|TWO_SIDED|95.0|-0.42|2.63|||ANCOVA|||The change from baseline to Week 26 is analyzed using an ANCOVA model using multiple imputations to fill in missing data and is parameterized with treatment groups, randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No) and the country as fixed effects, and baseline SBP as a covariate.||2.63|-0.42|0.1565
71864011|NCT05239598|143242443|SUPERIORITY||Mean Difference (Net)|1.7||||0.625|TWO_SIDED|95.0|-5.2|8.6|||t-test, 2 sided|||5 minutes post intervention||8.6|-5.2|0.625
71910224|NCT03351478|143341390|SUPERIORITY||percentage difference|8.1||||0.0048|TWO_SIDED|95.0|3.36|12.89|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||12.89|3.36|0.0048
71864012|NCT05239598|143242443|SUPERIORITY||Mean Difference (Net)|2.5||||0.526|TWO_SIDED|95.0|-5.5|10.5|||t-test, 2 sided|||30 minutes post intervention||10.5|-5.5|0.526
71864013|NCT05239598|143242444|SUPERIORITY||Median Difference (Net)|0.04||||0.511|TWO_SIDED|95.0|-4.2|8.1|||Signed Rank|||Povidone-iodine: 5 minutes Post-Intervention||8.1|-4.2|0.511
71864014|NCT05239598|143242444|SUPERIORITY||Median Difference (Net)|5.4||||0.408|TWO_SIDED|95.0|-10.7|18.6|||Signed Rank|||Povidone-iodine: 30 minutes post-intervention||18.6|-10.7|0.408
71910225|NCT03351478|143341391|SUPERIORITY||Percentage Difference|16.9||||0.0001|TWO_SIDED|95.0|9.26|24.52|||Cochran-Mantel-Haenszel|||The percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of metformin use at screening (Yes, No), and the randomization strata of mean SBP (\<130, ≥130 mmHg) at the screening.||24.52|9.26|0.0001
71864015|NCT05239598|143242444|SUPERIORITY||Median Difference (Net)|-4.9||||0.907|TWO_SIDED|95.0|-15.2|17.5|||Signed Rank|||Povidone-iodine: 60 minutes post-intervention||17.5|-15.2|0.907
71864016|NCT05239598|143242444|SUPERIORITY||Median Difference (Net)|-2.4||||0.008|TWO_SIDED|95.0|-6.5|-0.9|||Signed Rank|||Placebo: 5 minutes post intervention||-0.9|-6.5|0.008
71864017|NCT05239598|143242444|SUPERIORITY||Median Difference (Net)|-6.6||||0.08|TWO_SIDED|95.0|-10.1|-2.2|||Signed Rank|||Placebo: 30 minutes post-intervention||-2.2|-10.1|0.080
71864018|NCT05239598|143242444|SUPERIORITY||Median Difference (Net)|-8.6||||0.001|TWO_SIDED|95.0|-22.3|-3.9|||Signed Rank|||Placebo: 60 minutes post-intervention||-3.9|-22.3|0.001
71864019|NCT05239598|143242445|SUPERIORITY||Median Difference (Net)|3.1||||0.212|TWO_SIDED|95.0|-2.2|5.8|||Signed Rank|||Povidone-iodine 5 minutes post-intervention||5.8|-2.2|0.212
71864020|NCT05239598|143242445|SUPERIORITY||Median Difference (Net)|1.8||||0.334|TWO_SIDED|95.0|-2.3|6.9|||Signed Rank|||Povidone-iodine 30 minutes post-intervention||6.9|-2.3|0.334
71681971|NCT02542293|142881898|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.517|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.517|0.810|
71864021|NCT05239598|143242445|SUPERIORITY||Median Difference (Net)|1.5||||0.269|TWO_SIDED|95.0|-3.1|6.8|||Signed Rank|||Povidone-iodine 60 minutes post-intervention||6.8|-3.1|0.269
71864022|NCT05239598|143242445|SUPERIORITY||Median Difference (Net)|-4.1||||0.026|TWO_SIDED|95.0|-7.1|-0.7|||Signed Rank|||Placebo 5 minutes post-intervention||-0.7|-7.1|0.026
71864023|NCT05239598|143242445|SUPERIORITY||Median Difference (Net)|-0.7||||0.182|TWO_SIDED|95.0|-9.4|2.0|||Signed Rank|||Placebo 30 minutes post-intervention||2.0|-9.4|0.182
71864024|NCT05239598|143242445|SUPERIORITY||Median Difference (Net)|-3.6||||0.353|TWO_SIDED|95.0|-7.7|4.0|||Signed Rank|||Placebo 60 minutes post-intervention||4.0|-7.7|0.353
71864025|NCT04991753|143242460|SUPERIORITY||Least square mean difference|-0.45|||=|0.224|TWO_SIDED|95.0|-1.17|0.28|||ANCOVA|||||0.28|-1.17|=0.224
71864026|NCT03299049|143242476|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval (CI) for the Cochran-Mantel Haenzel (CMH) adjusted treatment difference (Q8W minus Q4W) is less than 4%.|Adjusted difference|0.8|||||TWO_SIDED|95.0|-0.6|2.2|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \>=50 c/mL between each treatment group (Q8W - Q4W) and corresponding 95% CI is presented.|||2.2|-0.6|
71864027|NCT03299049|143242477|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the two-sided 95% CI for the CMH adjusted treatment difference (Q8W minus Q4W) is greater than -10%|Adjusted difference|0.8|||||TWO_SIDED|95.0|-2.1|3.7|||||Adjusted CMH estimate of the difference in the percentage of participants with Plasma HIV-1 \<50 c/mL between each treatment group (Q8W-Q4W) and corresponding 95% CI is presented.|||3.7|-2.1|
71864028|NCT01901419|143242524|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||||||0.618
71864029|NCT01901419|143242525|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.410
71864030|NCT01901419|143242526|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71864031|NCT01901419|143242527|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
71864032|NCT01901419|143242528|SUPERIORITY|||||||0.512|||||||t-test, 2 sided|||||||0.512
71864033|NCT01901419|143242529|SUPERIORITY|||||||0.144|||||||t-test, 2 sided|||||||0.144
71864034|NCT01901419|143242530|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
71864035|NCT01901419|143242531|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
71864036|NCT01901419|143242532|SUPERIORITY|||||||0.478|||||||t-test, 2 sided|||||||0.478
71864037|NCT01901419|143242533|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
71864038|NCT01901419|143242534|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71864039|NCT01901419|143242535|SUPERIORITY|||||||0.227|||||||t-test, 2 sided|||||||0.227
71864040|NCT01901419|143242536|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
71864041|NCT01901419|143242537|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71864042|NCT01901419|143242538|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
71864043|NCT01901419|143242539|SUPERIORITY|||||||0.948|||||||t-test, 2 sided|||||||0.948
71864044|NCT01901419|143242540|SUPERIORITY|||||||0.682|||||||t-test, 2 sided|||||||0.682
71864045|NCT01901419|143242541|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||||||0.928
71864046|NCT01901419|143242542|SUPERIORITY|||||||0.672|||||||t-test, 2 sided|||||||0.672
71864047|NCT01901419|143242543|SUPERIORITY|||||||0.894|||||||t-test, 2 sided|||||||0.894
71864048|NCT01901419|143242544|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
71864049|NCT01901419|143242545|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||||||0.038
71864050|NCT01901419|143242546|SUPERIORITY|||||||0.852|||||||t-test, 2 sided|||||||0.852
71864051|NCT01901419|143242547|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||||||0.454
71864052|NCT01901419|143242548|SUPERIORITY|||||||0.663|||||||t-test, 2 sided|||||||0.663
71864053|NCT01901419|143242549|SUPERIORITY|||||||0.872|||||||t-test, 2 sided|||||||0.872
71864054|NCT01901419|143242550|SUPERIORITY|||||||0.318|||||||t-test, 2 sided|||||||0.318
71864055|NCT01901419|143242551|SUPERIORITY|||||||0.365|||||||t-test, 2 sided|||||||0.365
71864056|NCT01901419|143242552|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||||||0.077
71864057|NCT01901419|143242553|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||||||0.640
71910226|NCT00762268|143341403|SUPERIORITY_OR_OTHER|||||||1|||||||Regression, Linear|||||||1.0
71864058|NCT04486625|143242558|OTHER|Analysis of variance (ANOVA) was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% confidence intervals (CIs) for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|79.48|||||TWO_SIDED|90.0|66.52|94.96||||||||94.96|66.52|
71910227|NCT00762268|143341404|OTHER|||||||0.05|||||||Chi-squared|||Change from intake scores.||||0.05
71681972|NCT02542293|142881898|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.592|2.141|||||The HR and CI interval were calculated using an stratified Cox proportional hazards model, adjusting histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||2.141|0.592|
71864059|NCT04486625|143242559|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|75.58|||||TWO_SIDED|90.0|66.1|86.43||||||||86.43|66.10|
71864060|NCT04486625|143242560|OTHER|ANOVA was used to compare the natural log transformed AUC0-24,ss between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of of adjusted geometric means|124.19|||||TWO_SIDED|90.0|100.18|153.97||||||||153.97|100.18|
71864061|NCT04486625|143242561|OTHER|ANOVA was used to compare the natural log transformed Cmax between the normal renal function group (Reference) and the severe renal impairment group (Test). The geometric least squares mean point estimate and the associated 90% CIs for the difference of each comparison was estimated.|Ratio (%) of adjusted geometric means|102.42|||||TWO_SIDED|90.0|87.55|119.83||||||||119.83|87.55|
71864062|NCT02412735|143242587|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2072.|||
71864063|NCT02412735|143242587|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.6427.|||
71864064|NCT02412735|143242588|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2754.|||
71864065|NCT02412735|143242588|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.9087.|||
71864066|NCT02412735|143242589|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2835.|||
71864067|NCT02412735|143242589|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.4739.|||
71864068|NCT02412735|143242590|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2650.|||
71864069|NCT02412735|143242590|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.7004.|||
71864070|NCT02412735|143242591|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1945.|||
71864071|NCT02412735|143242591|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.8093.|||
71864072|NCT02412735|143242592|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.7842|TWO_SIDED|95.0|0.5|2.46|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% confidence interval (CI) were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.46|0.50|0.7842
71864073|NCT02412735|143242592|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.8754|TWO_SIDED|95.0|0.41|2.14|||Regression, Cox|P-value was calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|Hazard ratio and 95% CI were calculated from a Cox regression model with treatment, pooled site, and opioid/non opioid use at Baseline as covariates.|||2.14|0.41|0.8754
71864074|NCT02412735|143242593|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.2309.|||
71864075|NCT02412735|143242593|SUPERIORITY|The superiority threshold was 0.9875.|||||||||||||||||The posterior probability of superiority to placebo was 0.1241.|||
71910228|NCT00762268|143341405|OTHER|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71910229|NCT04446299|143341435|NON_INFERIORITY|The predetermined non-inferiority margin was 10%.|Risk Difference (RD)|3.42|||<|0.001|TWO_SIDED|95.0|-1.68|8.52|||Mantel Haenszel|||||8.52|-1.68|<0.001
71910230|NCT03819478|143341436|SUPERIORITY|||||||0.488|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4880
71910231|NCT03819478|143341436|SUPERIORITY|||||||0.1683|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1683
71864076|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.08||0.9072|TWO_SIDED|95.0|-5.71|6.43|||Mixed Model for Repeated Measures (MMRM)|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||6.43|-5.71|0.9072
71864077|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|3.14||0.2883|TWO_SIDED|95.0|-9.51|2.83|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 1||2.83|-9.51|0.2883
71864078|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|3.23||0.6314|TWO_SIDED|95.0|-7.9|4.8|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||4.80|-7.90|0.6314
71864079|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|3.29||0.1366|TWO_SIDED|95.0|-11.37|1.56|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 3||1.56|-11.37|0.1366
71864080|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.34||0.2497|TWO_SIDED|95.0|-10.43|2.72|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||2.72|-10.43|0.2497
71864081|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|3.42||0.0666|TWO_SIDED|95.0|-13.0|0.43|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 6||0.43|-13.00|0.0666
71864082|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.4||0.2147|TWO_SIDED|95.0|-10.91|2.46|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||2.46|-10.91|0.2147
71864083|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-8.4|STANDARD_ERROR_OF_MEAN|3.47||0.0162|TWO_SIDED|95.0|-15.19|-1.55|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 12||-1.55|-15.19|0.0162
71864084|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|3.67||0.223|TWO_SIDED|95.0|-11.69|2.74|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||2.74|-11.69|0.2230
71864085|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.74||0.1152|TWO_SIDED|95.0|-13.27|1.45|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 18||1.45|-13.27|0.1152
71864086|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|3.66||0.4884|TWO_SIDED|95.0|-9.75|4.67|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||4.67|-9.75|0.4884
71864087|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|3.74||0.0426|TWO_SIDED|95.0|-14.98|-0.25|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 24||-0.25|-14.98|0.0426
71864088|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|3.77||0.3056|TWO_SIDED|95.0|-11.27|3.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||3.54|-11.27|0.3056
71864089|NCT02412735|143242594|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|3.85||0.1184|TWO_SIDED|95.0|-13.59|1.54|||MMRM|MMRM was used with fixed effects of pooled site,baseline use of opioids,treatment,visit,treatment-by-visit interaction\&continuous covariate baseline.||Mean Change from Baseline in Low Back Pain VAS Score at Month 36||1.54|-13.59|0.1184
71864090|NCT01757197|143242608|OTHER|Not evaluable.|Other|0.0|||||TWO_SIDED|||||Not evaluable.||||Not evaluable.|Not evaluable.|||
71864091|NCT00186017|143242664|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
71864092|NCT00186017|143242665|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
71864093|NCT00186017|143242666|SUPERIORITY_OR_OTHER||||||>|0.1|||||||Wilcoxon (Mann-Whitney)|||||||>.1
71864094|NCT00874731|143242668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|||||TWO_SIDED|90.0|-2.8|3.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.76|-2.80|
71864095|NCT00874731|143242671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||||TWO_SIDED|95.0|-3.83|2.74|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.74|-3.83|
71864096|NCT00874731|143242672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-4.5|2.14|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|2.14|-4.50|
71864097|NCT00874731|143242673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-2.85|3.79|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|3.79|-2.85|
71864098|NCT00874731|143242674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18|||||TWO_SIDED|95.0|-2.1|4.47|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|4.47|-2.10|
71864099|NCT00874731|143242675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||||TWO_SIDED|95.0|-0.79|5.78|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.78|-0.79|
71864100|NCT00874731|143242676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48|||||TWO_SIDED|95.0|-0.8|5.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|5.76|-0.80|
71864101|NCT00874731|143242677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.89|||||TWO_SIDED|95.0|0.6|7.17|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|7.17|0.60|
71864102|NCT00874731|143242678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-4.85|1.86|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.|1.86|-4.85|
71864103|NCT01602510|143242797|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.438|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Treatment Group as covariate|||1.25|0.59|=0.438
71864104|NCT01602510|143242797|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.212|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with Site as covariate|||1.25|0.59|=0.212
71864105|NCT01602510|143242797|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.86|||=|0.724|TWO_SIDED|95.0|0.59|1.25|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.25|0.59|=0.724
71681973|NCT02542293|142881898|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.924|1.253|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.253|0.924|
71864106|NCT01602510|143242798|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.869|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Treatment Group as covariate|||1.66|0.55|=0.869
71864107|NCT01602510|143242798|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.061|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with Site as covariate|||1.66|0.55|=0.061
71864108|NCT01602510|143242798|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.95|||=|0.505|TWO_SIDED|95.0|0.55|1.66|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.66|0.55|=0.505
71864109|NCT01602510|143242799|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.369|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Treatment Group as covariate|||1.32|0.48|=0.369
71864110|NCT01602510|143242799|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.955|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with Site as covariate|||1.32|0.48|=0.955
71864111|NCT01602510|143242799|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|0.79|||=|0.874|TWO_SIDED|95.0|0.48|1.32|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.32|0.48|=0.874
71864112|NCT01602510|143242800|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.927|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Treatment Group as covariate|||1.40|0.73|=0.927
71864113|NCT01602510|143242800|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.036|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with Site as covariate|||1.40|0.73|=0.036
71864114|NCT01602510|143242800|SUPERIORITY_OR_OTHER||Adjusted Hazard Ratio|1.02|||=|0.509|TWO_SIDED|95.0|0.73|1.4|||Regression, Cox||p value with CGI-S Baseline Score as covariate|||1.40|0.73|=0.509
71864115|NCT01602510|143242801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||=|0.833|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||||0.5|-0.4|=0.833
71864116|NCT01602510|143242802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|||=|0.245|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.245
71864117|NCT01602510|143242803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||=|0.155|TWO_SIDED|95.0|-3.0|0.5|||ANCOVA|||||0.5|-3.0|=0.155
71864118|NCT01602510|143242804|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||=|0.661|TWO_SIDED|95.0|-1.4|2.2|||ANCOVA|||||2.2|-1.4|= 0.661
71864119|NCT01602510|143242805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||=|0.945|TWO_SIDED|95.0|-3.7|3.5|||ANCOVA|||||3.5|-3.7|= 0.945
71864120|NCT01602510|143242806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||=|0.047|TWO_SIDED|95.0|-1.66|-0.01|||ANCOVA|||||-0.01|-1.66|=0.047
71864121|NCT03519204|143242807|SUPERIORITY||Responder Rate Difference|84.7|||<|0.0001|TWO_SIDED|95.0|68.2|94.2||P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.|Fisher Exact|||||94.2|68.2|<0.0001
71864122|NCT03519204|143242809|SUPERIORITY||Median Difference|0.558|STANDARD_ERROR_OF_MEAN|0.109492|<|0.0001|TWO_SIDED|95.0|0.3447|0.7739||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||0.77390|0.34470|<0.0001
71864123|NCT03519204|143242810|SUPERIORITY||Median Difference|13.04|STANDARD_ERROR_OF_MEAN|2.122|<|0.0001|TWO_SIDED|95.0|8.861|17.18||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.|||17.180|8.861|<0.0001
71864124|NCT02627118|143242814|OTHER|||||||0.05|||||||t-test, 1 sided|||||||0.05
71864125|NCT01572740|143242815|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.3|||<|0.0001||95.0|-1.47|-1.13|||ANCOVA|||||-1.13|-1.47|<0.0001
71864126|NCT01572740|143242816|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.81|||<|0.0001||95.0|-0.99|-0.63|||ANCOVA|||||-0.63|-0.99|<0.0001
71864127|NCT01572740|143242817|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.83|||<|0.0006||95.0|-1.3|-0.36|||ANCOVA|||||-0.36|-1.30|<0.0006
71864128|NCT01572740|143242818|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.26||||0.2511||95.0|-0.7|0.18|||ANCOVA|||||0.18|-0.70|0.2511
71864129|NCT01572740|143242819|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.87|||<|0.0001||95.0|-2.37|-1.38|||ANCOVA|||||-1.38|-2.37|<0.0001
71864130|NCT01572740|143242820|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-1.28|||<|0.0001||95.0|-1.73|-0.83|||ANCOVA|||||-0.83|-1.73|<0.0001
71864131|NCT01572740|143242821|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.73||||0.0023||95.0|-1.2|-0.26|||ANCOVA|||||-0.26|-1.20|0.0023
71864132|NCT01572740|143242822|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.39||||0.1787||95.0|-0.97|0.18|||ANCOVA|||||0.18|-0.97|0.1787
71864133|NCT01572740|143242823|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.14||||0.4806||95.0|-0.54|0.25|||ANCOVA|||||0.25|-0.54|0.4806
71864134|NCT01572740|143242824|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-0.35||||0.2074||95.0|-0.91|0.2|||ANCOVA|||||0.20|-0.91|0.2074
71864135|NCT00477490|143242834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9303|TWO_SIDED|95.0|-0.221|0.242||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.242|-0.221|0.9303
71864136|NCT00477490|143242834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3104|TWO_SIDED|95.0|-0.353|0.112||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||0.112|-0.353|0.3104
71864137|NCT00477490|143242834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.277||||0.0207|TWO_SIDED|95.0|-0.511|-0.042||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.042|-0.511|0.0207
71864138|NCT00477490|143242834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.848|-0.378||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||-0.378|-0.848|<0.0001
71864139|NCT00477490|143242835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.017||||0.942|TWO_SIDED|95.0|0.647|1.598||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids||||1.598|0.647|0.9420
71864140|NCT00477490|143242835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.147||||0.5527|TWO_SIDED|95.0|0.729|1.807||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||||1.807|0.729|0.5527
71864141|NCT00477490|143242835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.296||||0.2662|TWO_SIDED|95.0|0.821|2.05||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||2.050|0.821|0.2662
71864142|NCT00477490|143242835|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.893|||<|0.0001|TWO_SIDED|95.0|1.795|4.715||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.||4.715|1.795|<0.0001
71864143|NCT00137969|143242846|SUPERIORITY_OR_OTHER|||||||0.4875||||||One-sided p-value.|Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.4875
71864144|NCT00137969|143242847|SUPERIORITY_OR_OTHER|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)||||0.8230
71864145|NCT00137969|143242848|SUPERIORITY_OR_OTHER|||||||0.4318|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.4318
71864146|NCT00137969|143242849|SUPERIORITY_OR_OTHER|||||||0.9069|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.9069
71864147|NCT00137969|143242850|SUPERIORITY_OR_OTHER|||||||0.5602|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.5602
71864148|NCT00137969|143242851|SUPERIORITY_OR_OTHER|||||||0.8979|||||||Log Rank|||Stratified by randomization factors (race and initial prednisone dose)||||0.8979
71910232|NCT03819478|143341437|SUPERIORITY|||||||0.7636|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.7636
71910233|NCT03819478|143341438|SUPERIORITY|||||||0.1584|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1584
71910234|NCT03819478|143341438|SUPERIORITY|||||||0.1623|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1623
71910235|NCT03819478|143341439|SUPERIORITY|||||||0.035|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0350
71910236|NCT03819478|143341440|SUPERIORITY|||||||0.2422|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.2422
71864149|NCT00137969|143242852|SUPERIORITY_OR_OTHER|||||||0.1277|||||||ANCOVA|||Stratified by randomization factors (race and initial prednisone dose)||||0.1277
71864150|NCT00137969|143242853|SUPERIORITY_OR_OTHER|||||||0.6202|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)||||0.6202
71864151|NCT01646177|143242861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864152|NCT01646177|143242861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864153|NCT01646177|143242861|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864154|NCT01646177|143242862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864155|NCT01646177|143242862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864156|NCT01646177|143242862|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864157|NCT01646177|143242863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864158|NCT01646177|143242863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864159|NCT01646177|143242863|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864160|NCT01646177|143242864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864161|NCT01646177|143242864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864162|NCT01646177|143242864|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864163|NCT01646177|143242865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864164|NCT01646177|143242865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71910237|NCT03819478|143341440|SUPERIORITY|||||||0.5082|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5082
71864165|NCT01646177|143242865|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864166|NCT01646177|143242866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864167|NCT01646177|143242866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864168|NCT01646177|143242866|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864169|NCT01646177|143242867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71910238|NCT03819478|143341441|SUPERIORITY|||||||0.5119|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5119
71910239|NCT03819478|143341441|SUPERIORITY|||||||0.4902|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.4902
71910240|NCT03819478|143341442|SUPERIORITY|||||||0.85|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.8500
71864170|NCT01646177|143242867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864171|NCT01646177|143242867|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864172|NCT01646177|143242868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864173|NCT01646177|143242868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864174|NCT01646177|143242868|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864175|NCT01646177|143242869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864176|NCT01646177|143242869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864177|NCT01646177|143242869|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864178|NCT01646177|143242870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864179|NCT01646177|143242870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864180|NCT01646177|143242870|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864181|NCT01646177|143242871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473|TWO_SIDED||||||ANCOVA|||||||0.473
71864182|NCT01646177|143242871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED||||||ANCOVA|||||||0.015
71910241|NCT03819478|143341443|SUPERIORITY|||||||0.3685|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.3685
71910242|NCT03819478|143341443|SUPERIORITY|||||||0.0894|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.0894
71910243|NCT03819478|143341444|SUPERIORITY|||||||0.5334|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.5334
71910244|NCT03819478|143341445|SUPERIORITY|||||||0.1573|||||||ANCOVA|Adjusted for age, sex, race, and baseline bone measure||||||0.1573
71922135|NCT03091920|143364997|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.67|||TWO_SIDED|95.0|-10.27|0.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.81|-10.27|
71922136|NCT03091920|143364998|OTHER|No statistical testing was performed.|Least squares mean difference|-4.87|STANDARD_ERROR_OF_MEAN|2.86|||TWO_SIDED|95.0|-10.8|1.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.06|-10.80|
71864183|NCT01646177|143242871|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71864184|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.006
71864185|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.045
71864186|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||Includes analysis only from Absenteeism Score.||||0.012
71864187|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
71864188|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
71864189|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Activity Impairment Score.||||<0.001
71864190|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
71864191|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
71864192|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Presenteeism Score.||||<0.001
71910245|NCT01135017|143341446|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean difference|-59.13|STANDARD_ERROR_OF_MEAN|0.275||0.0015|TWO_SIDED|95.0|-76.322|-29.457||No adjustment for multiplicity was made. The priori threshold for statistical significance was ≤0.05.|ANCOVA|ANCOVA model on log-transformed AF burden data with treatment arm as a fixed effect term and baseline log-transformed AF burden as a covariate|"Percent change in AF burden with dronedarone relative to placebo~LS Mean difference from the ANCOVA model on log-transformed AF burden data was exponentiated to convert back to percent change."|"The planned sample size of 286 participants was estimated to have 70% power to detect a reduction in mean AF burden of 30% relative to the placebo group.~Due to the smaller-than-planned sample size, the power to detect this difference was estimated to be only 44%, based on the original assumption. However, the power to detect larger treatment effects (\>40% reduction) remained high and the posthoc power to detect a 60% reduction in AF burden was 99%."||-29.457|-76.322|0.0015
71910246|NCT01148693|143341452|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%||||<0.05
71910247|NCT00091962|143341547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED|95.0||||repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.|Mixed Models Analysis|||||||0.001
71864193|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
71864194|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
71864195|NCT01646177|143242872|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.||||<0.001
71864196|NCT01646177|143242873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
71864197|NCT01646177|143242873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
71864198|NCT01646177|143242873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from PCS.||||<0.001
71864199|NCT01646177|143242873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.031|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||0.031
71864200|NCT01646177|143242873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
71864201|NCT01646177|143242873|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||ANCOVA|||Includes analysis only from MCS.||||<0.001
71864202|NCT01646177|143242874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864203|NCT01646177|143242874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864204|NCT01646177|143242874|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71864205|NCT01646177|143242875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864206|NCT01646177|143242875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864207|NCT01646177|143242875|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864208|NCT01646177|143242876|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864209|NCT01646177|143242876|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864210|NCT01646177|143242876|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864211|NCT01646177|143242877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864212|NCT01646177|143242877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864213|NCT01646177|143242877|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71864214|NCT00402051|143242895|SUPERIORITY_OR_OTHER||6-Month PFS Rate|52.8|||||TWO_SIDED|95.0|40.3|65.3||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||65.3|40.3|
71864215|NCT00402051|143242895|SUPERIORITY_OR_OTHER||6-Month PFS Rate|39.3|||||TWO_SIDED|95.0|27.8|50.8||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).||50.8|27.8|
71864216|NCT00402051|143242897|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|32.3||||||95.0|21.2|45.1||||||Response rates were evaluated separately for each treatment arm||45.1|21.2|
71864217|NCT00402051|143242897|SUPERIORITY_OR_OTHER||Best Overall Response Rate (%)|20.0||||||95.0|11.1|31.8||||||Response rates were evaluated separately for each treatment arm||31.8|11.1|
71864218|NCT01791972|143242907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|STANDARD_ERROR_OF_MEAN|1.982|<|0.0001|TWO_SIDED|95.0|-20.19|-12.14||Significance level is 0.05.|mixed-effect analysis of covariance|Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.||||-12.14|-20.19|<0.0001
71864219|NCT01791972|143242908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|0.53|0.84||Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.|Regression, Logistic|||||0.84|0.53|<0.0001
71864220|NCT02755129|143242940|OTHER||||||||||||||||||"To assess the similarity between the Reveal LINQ measures and those from the reference system, correlation coefficients were used.~The correlation coefficient was calculated over windows of 4 seconds and averaged for each exercise. Then, the average correlation coefficient over all patients and exercise was calculated."|||
71864221|NCT01424813|143242965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_ERROR_OF_MEAN|0.128|<|0.0001|TWO_SIDED|95.0|0.57|1.08||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.08|0.57|<0.0001
71864222|NCT01424813|143242966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|0.68|1.46||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.46|0.68|<0.0001
71864223|NCT01424813|143242981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.164|<|0.0001|TWO_SIDED|95.0|0.41|1.06||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||1.06|0.41|<0.0001
71864224|NCT01424813|143242982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.154|<|0.0001|TWO_SIDED|95.0|0.38|0.99||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially \[day 1, then day 8, then day 85\] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.||||0.99|0.38|<0.0001
71910248|NCT00587834|143341564|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact Bionomial Test|||Superiority relative to a pre-defined standard (50% success)||||<0.0001
71864225|NCT02614183|143242987|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.48|-1.37|||Mixed Models Analysis|||||-1.37|-2.48|<.001
71864226|NCT02614183|143242987|SUPERIORITY||Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.31|-1.2|||Mixed Models Analysis|||||-1.20|-2.31|<.001
71864227|NCT02614183|143242988|SUPERIORITY||Odds Ratio (OR)|2.63|||||TWO_SIDED|95.0|2.05|3.37||||||Reduction from Baseline ≥50%||3.37|2.05|
71910249|NCT00587834|143341565|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red||||<0.0001
71910250|NCT00587834|143341566|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||McNemar|||Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm||||<0.0001
71864228|NCT02614183|143242988|SUPERIORITY||Odds Ratio (OR)|2.48|||||TWO_SIDED|95.0|1.94|3.18||||||Reduction from Baseline ≥50%||3.18|1.94|
71864229|NCT02614183|143242988|SUPERIORITY||Odds Ratio (OR)|2.65|||||TWO_SIDED|95.0|2.04|3.45||||||Reduction from Baseline ≥75%||3.45|2.04|
71864230|NCT02614183|143242988|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|2.01|3.41||||||Reduction from Baseline ≥75%||3.41|2.01|
71910251|NCT00587834|143341567|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||Superiority relative to a pre-defined threshold (80%) success||||<0.0001
71864231|NCT02614183|143242988|SUPERIORITY||Odds Ratio (OR)|2.8|||||TWO_SIDED|95.0|1.96|4.01||||||Reduction from Baseline = 100%||4.01|1.96|
71864232|NCT02614183|143242988|SUPERIORITY||Odds Ratio (OR)|2.61|||||TWO_SIDED|95.0|1.81|3.75||||||Reduction from Baseline = 100%||3.75|1.81|
71864233|NCT02614183|143242989|SUPERIORITY||Mean Difference (Final Values)|7.74|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|5.2|10.28|||Mixed Models Analysis|||||10.28|5.20|<.001
71864234|NCT02614183|143242989|SUPERIORITY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|1.31|<|0.001|TWO_SIDED|95.0|4.83|9.97|||Mixed Models Analysis|||||9.97|4.83|<.001
71864235|NCT02614183|143242990|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.28|-1.33|||Mixed Models Analysis|||||-1.33|-2.28|<.001
71864236|NCT02614183|143242990|SUPERIORITY||Odds Ratio (OR)|-1.61|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.09|-1.14|||Mixed Models Analysis|||||-1.14|-2.09|<.001
71910252|NCT00587834|143341568|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Exact binomial test|||The proportion of Gintuit as the preferred procedure.||||<0.0001
71910253|NCT00587834|143341569|SUPERIORITY_OR_OTHER|||||||0.3173||95.0|||||McNemar|McNemar's paired comparison test||Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.||||0.3173
71910254|NCT01654523|143341634|SUPERIORITY_OR_OTHER||Mean change in the single arm trial|6.695|STANDARD_DEVIATION|5.505|<|0.05|TWO_SIDED|95.0|4.041|9.348|||Paired t-test|||||9.348|4.041|<0.05
71910255|NCT00435994|143341643|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||0.0020
71910256|NCT00435994|143341644|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANOVA|||||||.0020
71864237|NCT02614183|143242991|SUPERIORITY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.52|-0.12|||Mixed Models Analysis|||||-0.12|-0.52|<.001
71864238|NCT02614183|143242991|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.48|-0.07|||Mixed Models Analysis|||||-0.07|-0.48|<.001
71864239|NCT02614183|143242992|SUPERIORITY||Mean Difference (Final Values)|-13.98|STANDARD_ERROR_OF_MEAN|2.55|<|0.001|TWO_SIDED|95.0|-18.99|-8.97|||Mixed Models Analysis|||||-8.97|-18.99|<.001
71864240|NCT02614183|143242992|SUPERIORITY||Mean Difference (Final Values)|-13.64|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED|95.0|-18.68|-8.6|||Mixed Models Analysis|||||-8.60|-18.68|<.001
71910257|NCT05109702|143341647|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.094||0.764|TWO_SIDED|95.0|-0.214|0.157|||MMRM|||The Least Square (LS) means, LS mean difference, Standard Errors (SEs), two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the Mixed model repeated measures (MMRM) model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.157|-0.214|0.764
71864241|NCT02614183|143242993|SUPERIORITY||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.61|<|0.001|TWO_SIDED|95.0|-9.45|-3.13|||Mixed Models Analysis|||||-3.13|-9.45|<.001
71864242|NCT02614183|143242993|SUPERIORITY||Mean Difference (Final Values)|-5.19|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-8.39|-1.98|||Mixed Models Analysis|||||-1.98|-8.39|<.001
71864243|NCT02614183|143242994|SUPERIORITY||||||<|0.16|||||||Fisher Exact|||TE ADA Positive.||||<.160
71864244|NCT02614183|143242994|SUPERIORITY|||||||0.02|||||||Fisher Exact|||TE ADA Positive.||||.020
71864245|NCT02614183|143242994|SUPERIORITY|||||||0.131|||||||Fisher Exact|||Neutralizing Antibodies.||||.131
71864246|NCT02614183|143242994|SUPERIORITY|||||||0.009|||||||Fisher Exact|||Neutralizing Antibodies.||||.009
71864247|NCT01088984|143243006|SUPERIORITY_OR_OTHER|||||||1||||||1-sided p-value is calculated against the null hypothesis of a response rate of 5%.|binomial parameter exact method|||||||1.0000
71864248|NCT01006980|143243039|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.26|0.55|||Log Rank||The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.|The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.||0.55|0.26|<0.0001
71864249|NCT01006980|143243040|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.2|0.33|||Log Rank||Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.|The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).||0.33|0.20|<.0001
71864250|NCT01182441|143243086|SUPERIORITY|Success for this endpoint was achieved if the probability of experiencing an event was statistically less than the performance goal, defined as 2.67%, with an upper bound of the one-sided 95% credible interval less than the performance goal.|probability of experiencing an event|2.2|||||ONE_SIDED|95.0||2.652||||||Bayesian calculations were used to incorporate the data from PROTECT AF CAP Registry through a conjugate beta-binomial model. A one-sided upper 95% credible interval for the event rate was calculated based off this posterior distribution.||2.652||
71864251|NCT01182441|143243087|NON_INFERIORITY|This endpoint is met if the 95% Credible Interval for the rate ratio of WATCHMAN versus Warfarin is entirely less than 1.75.|Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.57|1.89||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval model were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately by treatment group and event type. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||1.89|0.57|
71864252|NCT01182441|143243088|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Difference (RD)|0.0053|||||TWO_SIDED|95.0|-0.019|0.0273||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||0.0273|-0.0190|
71864253|NCT01182441|143243088|NON_INFERIORITY|This endpoint is met if either the 95% Credible Interval for the risk ratio \< 2.0 or the 95% Credible Interval for the risk difference is \< 0.0275.|Risk Ratio (RR)|1.6|||||TWO_SIDED|95.0|0.5|4.2||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.||4.2|0.5|
71864254|NCT02304705|143243138|SUPERIORITY|||||||0.052|||||||t-test, 2 sided|||||||.052
71864255|NCT05504954|143243156|SUPERIORITY||Odds Ratio (OR)|0.26||||0.15|TWO_SIDED|95.0|0.04|1.59|||Regression, Logistic|||||1.59|0.04|0.15
71864256|NCT05504954|143243158|SUPERIORITY||Odds Ratio (OR)|2.83||||0.1|TWO_SIDED|95.0|0.81|9.89|||Regression, Logistic|||||9.89|0.81|0.10
71910258|NCT05109702|143341648|SUPERIORITY||LS Mean Difference|4.34|STANDARD_ERROR_OF_MEAN|2.969||0.144|TWO_SIDED|95.0|-1.483|10.155|||MMRM|||The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.155|-1.483|0.144
71864257|NCT05504954|143243159|SUPERIORITY||beta coefficient|5.0||||0.65|TWO_SIDED|95.0|-17.78|27.78|||Regression, Linear|||||27.78|-17.78|0.65
71864258|NCT05504954|143243160|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||0.70
71864259|NCT05504954|143243161|SUPERIORITY|||||||0.7|||||||Fisher Exact|||||||.70
71864260|NCT05504954|143243162|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71864261|NCT05504954|143243163|SUPERIORITY|||||||0.64|||||||Fisher Exact|||||||0.64
71864262|NCT01174446|143243176|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence will be established if 90% C.I. of ratio is contained completely in the margins of equivalence of 0.8 to 1.25.|Ratio of Geometric Means|1.063|||||TWO_SIDED|90.0|1.03|1.09||||||||1.09|1.03|
71864263|NCT01174446|143243203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.779||95.0|||||Paired t-test|||||||0.7790
71864264|NCT01174446|143243203|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8999||95.0|||||Paired t-test|||||||0.8999
71864265|NCT01174446|143243204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0056||95.0|||||Paired t-test|||||||0.0056
71864266|NCT01174446|143243204|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413||95.0|||||Paired t-test|||||||0.4130
71864267|NCT01174446|143243205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9059||95.0|||||Paired t-test|||||||0.9059
71864268|NCT01174446|143243205|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4098||95.0|||||Paired t-test|||||||0.4098
71864269|NCT01174446|143243206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0189||95.0|||||Paired t-test|||||||0.0189
71864270|NCT01174446|143243206|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2974||95.0|||||Paired t-test|||||||0.2974
71864271|NCT01174446|143243207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2009||95.0|||||Paired t-test|||||||0.2009
71864272|NCT01174446|143243207|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3552||95.0|||||Paired t-test|||||||0.3552
71864273|NCT01174446|143243208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5143||95.0|||||Paired t-test|||||||0.5143
71864274|NCT01174446|143243208|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9223||95.0|||||Paired t-test|||||||0.9223
71864275|NCT01174446|143243209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0162||95.0|||||Paired t-test|||||||0.0162
71864276|NCT01174446|143243209|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3176||95.0|||||Paired t-test|||||||0.3176
71864277|NCT01174446|143243210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.821||95.0|||||Paired t-test|||||||0.8210
71864278|NCT01174446|143243210|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5565||95.0|||||Paired t-test|||||||0.5565
71864279|NCT01174446|143243211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146||95.0|||||Paired t-test|||||||0.0146
71864280|NCT01174446|143243211|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4048||95.0|||||Paired t-test|||||||0.4048
71864281|NCT01174446|143243212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1258||95.0|||||Paired t-test|||||||0.1258
71864282|NCT01174446|143243212|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2567||95.0|||||Paired t-test|||||||0.2567
71864283|NCT01174446|143243213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1048||95.0|||||Paired t-test|||||||0.1048
71864284|NCT01174446|143243213|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||95.0|||||Paired t-test|||||||0.6410
71864285|NCT01174446|143243214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0663||95.0|||||Paired t-test|||||||0.0663
71864286|NCT01174446|143243214|SUPERIORITY_OR_OTHER_LEGACY|||||||0.489||95.0|||||Paired t-test|||||||0.4890
71864287|NCT01174446|143243215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0562||95.0|||||Paired t-test|||||||0.0562
71864288|NCT01174446|143243215|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3864||95.0|||||Paired t-test|||||||0.3864
71864289|NCT01174446|143243216|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5792||95.0|||||Paired t-test|||||||0.5792
71864290|NCT01174446|143243217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4208||95.0|||||Paired t-test|||||||0.4208
71864291|NCT01174446|143243218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5||95.0|||||Paired t-test|||||||0.5000
71864292|NCT01174446|143243219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0633||95.0|||||Paired t-test|||||||0.0633
71864293|NCT01174446|143243219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363||95.0|||||Paired t-test|||||||0.9363
71864294|NCT00847626|143243227|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.001|TWO_SIDED|95.0|-15.8|-9.5||Tested at 5% significance level.|ANCOVA|||Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-9.5|-15.8|<0.001
71864295|NCT00847626|143243227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.8|||<|0.001|TWO_SIDED|95.0|-16.7|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.9|-16.7|<0.001
71864296|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|||<|0.001|TWO_SIDED|95.0|-16.2|-9.2||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.2|-16.2|<0.001
71864297|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9|||<|0.001|TWO_SIDED|95.0|-13.4|-6.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-6.4|-13.4|<0.001
71864298|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|||<|0.001|TWO_SIDED|95.0|-19.2|-12.1||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.1|-19.2|<0.001
71864299|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.4|||<|0.001|TWO_SIDED|95.0|-15.8|-8.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.9|-15.8|<0.001
71864300|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.8|||<|0.001|TWO_SIDED|95.0|-19.3|-12.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.3|-19.3|<0.001
71864301|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.0|||<|0.001|TWO_SIDED|95.0|-16.5|-9.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.5|-16.5|<0.001
71681974|NCT02542293|142881898|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.655|1.362|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥ 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.362|0.655|
71681975|NCT02542293|142881898|SUPERIORITY||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.621|1.024|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.024|0.621|
71864302|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|||<|0.001|TWO_SIDED|95.0|-17.5|-10.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.5|-17.5|<0.001
71864303|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|||<|0.001|TWO_SIDED|95.0|-20.6|-13.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.7|-20.6|<0.001
71864304|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.5|||<|0.001|TWO_SIDED|95.0|-17.0|-9.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.9|-17.0|<0.001
71681976|NCT02542293|142881898|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.389|1.317|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.317|0.389|
71681977|NCT02542293|142881898|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.542|1.01|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.010|0.542|
71681978|NCT02542293|142881898|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.335|1.251|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC."||1.251|0.335|
71681979|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.236|1.03||||||"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.030|0.236|
71681980|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|0.53|||||TWO_SIDED|95.0|0.288|0.968||||||"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.968|0.288|
71681981|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.336|0.908||||||"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.908|0.336|
71681982|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|1.96|||||TWO_SIDED|95.0|0.752|5.234||||||"tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.234|0.752|
71681983|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.482|2.214||||||"tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||2.214|0.482|
71681984|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.43|1.548||||||"tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.548|0.430|
71681985|NCT02542293|142881899|SUPERIORITY||Odds Ratio (OR)|0.83|||||TWO_SIDED|95.0|0.456|1.486||||||"tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.486|0.456|
71681986|NCT02542293|142881900|SUPERIORITY||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.245|0.869|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.869|0.245|
71864305|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2|||<|0.001|TWO_SIDED|95.0|-19.7|-12.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.7|-19.7|<0.001
71681987|NCT02542293|142881900|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.42|||||TWO_SIDED|95.0|0.124|1.337|||Binomial exact test|||"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.337|0.124|
71864306|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.3|-9.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.3|-16.3|<0.001
71864307|NCT00847626|143243228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0|||<|0.001|TWO_SIDED|95.0|-19.4|-12.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-12.6|-19.4|<0.001
71864308|NCT00847626|143243229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8||||0.255|TWO_SIDED|95.0|-13.0|3.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||3.5|-13.0|0.255
71864309|NCT00847626|143243229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-25.9|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.||-10.6|-25.9|<0.001
71864310|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.3|||<|0.001|TWO_SIDED|95.0|-13.6|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.6|< 0.001
71864311|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||<|0.001|TWO_SIDED|95.0|-13.7|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.0|-13.7|<0.001
71864312|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|||<|0.001|TWO_SIDED|95.0|-15.1|-8.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.4|-15.1|<0.001
71864313|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|||<|0.001|TWO_SIDED|95.0|-17.3|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.6|-17.3|<0.001
71864314|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|||<|0.001|TWO_SIDED|95.0|-17.1|-10.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.3|-17.1|<0.001
71864315|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0|||<|0.001|TWO_SIDED|95.0|-15.4|-8.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.7|-15.4|<0.001
71864316|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-14.2|-7.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.6|-14.2|<0.001
71864317|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.2|||<|0.001|TWO_SIDED|95.0|-17.6|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-10.9|-17.6|<0.001
71864318|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.6|||<|0.001|TWO_SIDED|95.0|-15.0|-8.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-8.3|-15.0|<0.001
71864319|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.0|||<|0.001|TWO_SIDED|95.0|-20.4|-13.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-13.6|-20.4|<0.001
71864320|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.2|||<|0.001|TWO_SIDED|95.0|-14.7|-7.8||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-7.8|-14.7|<0.001
71864321|NCT00847626|143243242|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||<|0.001|TWO_SIDED|95.0|-16.2|-9.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.||-9.4|-16.2|<0.001
71864322|NCT00659880|143243269|SUPERIORITY_OR_OTHER|||||||0.06|||||||Friedman|||||||0.06
71864323|NCT01465763|143243291|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).||16.3|4.3|0.0070
71864324|NCT01465763|143243292|SUPERIORITY_OR_OTHER||Percent Difference|15.7||||0.0005|TWO_SIDED|95.0|8.1|23.4|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||23.4|8.1|0.0005
71864325|NCT01465763|143243293|SUPERIORITY_OR_OTHER||Percent Difference|27.1|||<|0.0001|TWO_SIDED|95.0|17.7|36.5|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.5|17.7|<0.0001
71922137|NCT03091920|143364998|OTHER|No statistical testing was performed.|Least squares mean difference|-5.02|STANDARD_ERROR_OF_MEAN|2.82|||TWO_SIDED|95.0|-10.87|0.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||0.83|-10.87|
71864326|NCT01465763|143243294|SUPERIORITY_OR_OTHER||Percent Difference|5.1||||0.0345|TWO_SIDED|95.0|1.9|8.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.3|1.9|0.0345
71864327|NCT01465763|143243295|SUPERIORITY_OR_OTHER||Percent Difference|10.3||||0.007|TWO_SIDED|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||16.3|4.3|0.0070
71864328|NCT01465763|143243296|SUPERIORITY_OR_OTHER||Percent Difference|6.0||||0.0601|TWO_SIDED|95.0|1.0|11.1|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||11.1|1.0|0.0601
71864329|NCT01465763|143243297|SUPERIORITY_OR_OTHER||Percent Difference|6.5||||0.0043|TWO_SIDED|95.0|4.3|8.7|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.7|4.3|0.0043
71864330|NCT01465763|143243299|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||Mixed-Effects Model|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.5|-1.3|<0.0001
71864331|NCT01465763|143243299|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed-Effects Model|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-0.7|-1.5|<0.0001
71864332|NCT01465763|143243299|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.9|-1.1|||Mixed-Effects Model|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.||-1.1|-1.9|<0.0001
71864333|NCT01465763|143243300|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.5|-1.4|||ANCOVA|||The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.4|-2.5|<0.0001
71864334|NCT01711853|143243319|SUPERIORITY_OR_OTHER|||||||0.5186|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.5186
71864335|NCT01711853|143243319|SUPERIORITY_OR_OTHER|||||||0.9883|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9883
71864336|NCT01711853|143243319|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.7853
71864337|NCT01711853|143243320|SUPERIORITY_OR_OTHER|||||||0.4692|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: \> median GFR).~Median is calculated based on trial data of treated set"||||0.4692
71864338|NCT01711853|143243320|SUPERIORITY_OR_OTHER|||||||0.9734|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: \> median age).~Median is calculated based on trial data of treated set"||||0.9734
71864339|NCT01711853|143243320|SUPERIORITY_OR_OTHER|||||||0.9201|TWO_SIDED||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.||||0.9201
71864340|NCT02992691|143243330|OTHER||Mean Difference (Net)|-0.01||||0.6674|TWO_SIDED|95.0|-0.06|0.04||From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.|ANCOVA|||This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments||0.04|-0.06|0.6674
71864341|NCT00392925|143243386|SUPERIORITY_OR_OTHER|||||||0.0004|||||||ANCOVA|||Based on an Analysis of Covariance model including factors for treatment group, sex, enrollment body mass index (BMI) category, lead-in body weight loss category, and baseline (Day 1) weight as a covariate. The p-value is for testing the null hypothesis of no difference between treatments. Analysis performed two-sided at a 5% significance level to compare treatment groups.||||0.0004
71864342|NCT01621776|143243412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.1|STANDARD_DEVIATION|78.04||0.971||95.0|129.73|160.47|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||160.47|129.73|.971
71864343|NCT01621776|143243413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|161.09|STANDARD_DEVIATION|62.67||0.698|TWO_SIDED|95.0|144.91|177.28|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||177.28|144.91|.698
71864344|NCT01621776|143243414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|220.46|STANDARD_DEVIATION|89.97||0.806|TWO_SIDED|95.0|197.22|243.71|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.|||243.71|197.22|.806
71864345|NCT02269423|143243423|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
71864346|NCT02269423|143243423|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
71864347|NCT02269423|143243423|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
71864348|NCT02269423|143243423|OTHER|||||||0.161||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.161
71864349|NCT02269423|143243423|OTHER|||||||0.008||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.008
71681988|NCT02542293|142881900|SUPERIORITY||Odds Ratio (OR)|0.48|||||TWO_SIDED|95.0|0.356|0.647|||||The analysis was performed using logistic regression adjusting for PD-L1 status (≥25% Vs \<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||0.647|0.356|
71882518|NCT01505634|143284130|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||4.6|-4.5|
71681989|NCT02542293|142881900|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.45|1.66|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.660|0.450|
71864350|NCT02269423|143243423|OTHER|||||||0.173||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.173
71681990|NCT02542293|142881900|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.443|1.079|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥25% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.079|0.443|
71681991|NCT02542293|142881900|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.658|4.919|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥ 25% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||4.919|0.658|
71681992|NCT02542293|142881900|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.449|1.291|||||The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||1.291|0.449|
71681993|NCT02542293|142881900|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.585|5.27|||||The analysis was performed using logistic regression, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|"PD-L1 TC ≥50% analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~An odds ratio \>1 favors Durvalumab + Tremelimumab combination therapy over SoC."||5.270|0.585|
71681994|NCT02542293|142881901|SUPERIORITY||Hazard Ratio (HR)|0.25|||||TWO_SIDED|95.0|0.113|0.532|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.532|0.113|
71681995|NCT02542293|142881901|SUPERIORITY||Hazard Ratio (HR)|0.36|||||TWO_SIDED|95.0|0.196|0.639|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.639|0.196|
71681996|NCT02542293|142881901|SUPERIORITY||Hazard Ratio (HR)|0.38|||||TWO_SIDED|95.0|0.233|0.611|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.611|0.233|
71681997|NCT02542293|142881902|SUPERIORITY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.199|0.787|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.787|0.199|
71681998|NCT02542293|142881902|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.183|2.86|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||2.860|0.183|
71681999|NCT02542293|142881902|SUPERIORITY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.324|0.588|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.588|0.324|
71682000|NCT02542293|142881902|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.193|0.761|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC."||0.761|0.193|
71682001|NCT02542293|142881905|SUPERIORITY||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.494|1.058|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.058|0.494|
71682002|NCT02542293|142881905|SUPERIORITY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.607|1.151|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.151|0.607|
71682003|NCT02542293|142881905|SUPERIORITY||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.689|1.146|||||The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.|"bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.146|0.689|
71864351|NCT02269423|143243424|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
71864352|NCT02269423|143243424|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
71910259|NCT05109702|143341649|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.094||0.056|TWO_SIDED|95.0|-0.005|0.363|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.363|-0.005|0.056
71910260|NCT05109702|143341649|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.094||0.064|TWO_SIDED|95.0|-0.01|0.359|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.359|-0.010|0.064
71864353|NCT02269423|143243424|OTHER||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||<0.001
71864354|NCT02269423|143243424|OTHER|||||||0.102||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.102
71864355|NCT02269423|143243424|OTHER|||||||0.124||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.124
71864356|NCT02269423|143243424|OTHER|||||||0.918||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28||||0.918
71864357|NCT00755105|143243431|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||||||< 0.05
71864358|NCT01281839|143243433|SUPERIORITY_OR_OTHER||Difference in proportions of SVR12|43.8|||<|0.001|TWO_SIDED|95.0|34.6|53.0|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.||53.0|34.6|<0.001
71864359|NCT01281839|143243434|SUPERIORITY_OR_OTHER||Difference in proportions of SVR72|43.3|||<|0.001|TWO_SIDED|95.0|34.1|52.5|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR72 between the treatment groups.||52.5|34.1|<0.001
71864360|NCT01281839|143243435|SUPERIORITY_OR_OTHER||Difference in proportions of SVR24|44.1|||<|0.001|TWO_SIDED|95.0|34.9|53.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||53.2|34.9|<0.001
71864361|NCT01281839|143243436|SUPERIORITY_OR_OTHER||Difference in proportions of SVR4|41.0|||<|0.001|TWO_SIDED|95.0|32.1|49.9|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.||49.9|32.1|<0.001
71864362|NCT03168542|143243503|SUPERIORITY|Superiority was concluded if the lower 95% of the confidence limit of the proportion of subjects who require no more than one modification was greater than 50%.|Proportion|0.952|||||TWO_SIDED|95.0|0.756|1.0|||Agresti-Coull confidence interval|Agresti-Coull method was used to estimate the confidence interval of the binomial proportions.||||1.000|0.756|
71864363|NCT00203268|143243514|SUPERIORITY_OR_OTHER|||||||0.3025|||||||clustered survival analysis|||||||.3025
71864364|NCT02514551|143243527|SUPERIORITY||Hazard Ratio (HR)|0.617|||||TWO_SIDED|95.0|0.447|0.853|||||Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)|"This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)"||0.853|0.447|
71864365|NCT02514551|143243528|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.727|1.274|||||Unstratified cox proportional hazards model.|||1.274|0.727|
71864366|NCT04944290|143243549|EQUIVALENCE|8AM Day 14|Mean Difference (Net)|-0.14|||||TWO_SIDED|95.0|-0.71|0.51||||||||0.51|-0.71|
71864367|NCT04944290|143243549|EQUIVALENCE|10AM Day 14|Mean Difference (Net)|-0.35|||||TWO_SIDED|95.0|-0.86|0.26||||||10AM Day 14||0.26|-0.86|
71864368|NCT04944290|143243549|EQUIVALENCE|8AM Day 42|Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.58|0.58||||||||0.58|-0.58|
71864369|NCT04944290|143243549|EQUIVALENCE|10AM Day 42|Mean Difference (Net)|-0.16|||||TWO_SIDED|95.0|-0.7|0.47||||||||0.47|-0.70|
71864370|NCT03838731|143243550|SUPERIORITY||Hazard Ratio (HR)|0.36|||=|0.0083|TWO_SIDED|95.0|0.17|0.77|||Cox Proportional Hazard|||||0.77|0.17|= 0.0083
71864371|NCT03838731|143243551|SUPERIORITY||Hazard Ratio (HR)|0.24|||<|0.0001|TWO_SIDED|95.0|0.12|0.48|||Cox Hazard Model|||Day 29||0.48|0.12|< 0.0001
71864372|NCT03838731|143243551|SUPERIORITY||Hazard Ratio (HR)|0.45|||=|0.0222||95.0|0.22|0.89|||Cox Hazard Model|||Day 57||0.89|0.22|= 0.0222
71864373|NCT03838731|143243551|SUPERIORITY||Hazard Ratio (HR)|0.27|||=|0.0003||95.0|0.13|0.56|||Cox Hazard Model|||Day 85||0.56|0.13|= 0.0003
71864374|NCT03838731|143243552|SUPERIORITY|Day 8|LS Mean Difference|13.56|STANDARD_ERROR_OF_MEAN|3.59|<|0.001|TWO_SIDED|95.0|6.35|20.77|||MMRM|||||20.77|6.35|<0.001
71864375|NCT03838731|143243552|SUPERIORITY|Day 29|LS Mean Difference|16.21|STANDARD_ERROR_OF_MEAN|4.97|=|0.002|TWO_SIDED|95.0|6.18|26.24|||MMRM|||||26.24|6.18|= 0.002
71910261|NCT05109702|143341649|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.095||0.328|TWO_SIDED|95.0|-0.093|0.279|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.279|-0.093|0.328
71864376|NCT03838731|143243552|SUPERIORITY|Day 57|LS Mean Difference|12.3|STANDARD_ERROR_OF_MEAN|4.94|=|0.016|TWO_SIDED|95.0|2.4|22.2|||MMRM|||||22.20|2.40|= 0.016
71864377|NCT03838731|143243552|SUPERIORITY|Day 85|LS Mean Difference|12.54|STANDARD_ERROR_OF_MEAN|4.54|=|0.008|TWO_SIDED|95.0|3.43|21.65|||MMRM|||||21.65|3.43|= 0.008
71864378|NCT03838731|143243553|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.21|0.53|||MMRM|||Day 8||0.53|0.21|< 0.001
71864379|NCT03838731|143243553|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|0.23|0.68|||MMRM|||Day 29||0.68|0.23|<0.001
71864380|NCT03838731|143243553|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.13|0.55|||MMRM|||Day 57||0.55|0.13|= 0.002
71864381|NCT03838731|143243553|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.11|=|0.002|TWO_SIDED|95.0|0.15|0.47|||MMRM|||Day 85||0.47|0.15|= 0.002
71864382|NCT03838731|143243554|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.53|=|0.675|TWO_SIDED|95.0|-0.85|1.29|||MMRM|||Day 8||1.29|-0.85|= 0.675
71864383|NCT03838731|143243554|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.51|=|0.182|TWO_SIDED|95.0|-1.7|0.33|||MMRM|||Day 29||0.33|-1.70|= 0.182
71864384|NCT03838731|143243554|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.61|=|0.866|TWO_SIDED|95.0|-1.12|1.32|||MMRM|||Day 57||1.32|-1.12|= 0.866
71864385|NCT03838731|143243554|SUPERIORITY||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|0.6|=|0.146|TWO_SIDED|95.0|-2.08|0.32|||MMRM|||Day 85||0.32|-2.08|= 0.146
71864386|NCT03838731|143243555|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.24|=|0.572|TWO_SIDED|95.0|-0.35|0.63|||MMRM|||Day 8||0.63|-0.35|= 0.572
71864387|NCT03838731|143243555|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.2|=|0.997|TWO_SIDED|95.0|-0.41|0.41|||MMRM|||Day 29||0.41|-0.41|= 0.997
71864388|NCT03838731|143243555|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.21|=|0.756|TWO_SIDED|95.0|-0.36|0.49|||MMRM|||Day 57||0.49|-0.36|= 0.756
71864389|NCT03838731|143243555|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.15|=|0.333|TWO_SIDED|95.0|-0.46|0.16|||MMRM|||Day 85||0.16|-0.46|= 0.333
71864390|NCT03838731|143243556|SUPERIORITY||LS Mean Difference|39.5|STANDARD_ERROR_OF_MEAN|12.5|=|0.003|TWO_SIDED|95.0|14.36|64.65|||MMRM|||Day 8||64.65|14.36|= 0.003
71864391|NCT03838731|143243556|SUPERIORITY||LS Mean Difference|54.07|STANDARD_ERROR_OF_MEAN|11.97|<|0.001|TWO_SIDED|95.0|30.01|78.12|||MMRM|||Day 29||78.12|30.01|< 0.001
71864392|NCT03838731|143243556|SUPERIORITY||LS Mean Difference|33.44|STANDARD_ERROR_OF_MEAN|14.28|=|0.023|TWO_SIDED|95.0|4.79|62.08|||MMRM|||Day 57||62.08|4.79|= 0.023
71864393|NCT03838731|143243556|SUPERIORITY||LS Mean Difference|41.1|STANDARD_ERROR_OF_MEAN|12.92|=|0.003|TWO_SIDED|95.0|15.1|67.09|||MMRM|||Day 85||67.09|15.10|= 0.003
71864394|NCT03838731|143243557|SUPERIORITY||LS Mean Difference|205.43|STANDARD_ERROR_OF_MEAN|102.09|=|0.049|TWO_SIDED|95.0|0.69|410.17|||MMRM|||Day 8||410.17|0.69|= 0.049
71864395|NCT03838731|143243557|SUPERIORITY||LS Mean Difference|244.6|STANDARD_ERROR_OF_MEAN|99.05|=|0.017|TWO_SIDED|95.0|45.6|443.59|||MMRM|||Day 29||443.59|45.60|= 0.017
71864396|NCT03838731|143243557|SUPERIORITY||LS Mean Difference|183.03|STANDARD_ERROR_OF_MEAN|96.91|=|0.064|TWO_SIDED|95.0|-11.29|377.35|||MMRM|||Day 57||377.35|-11.29|= 0.064
71864397|NCT03838731|143243557|SUPERIORITY||LS Mean Difference|241.01|STANDARD_ERROR_OF_MEAN|114.0|=|0.039|TWO_SIDED|95.0|12.44|469.57|||MMRM|||Day 85||469.57|12.44|= 0.039
71864398|NCT00770029|143243578|SUPERIORITY_OR_OTHER||Difference response rate|0.6|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001|TWO_SIDED|95.0|0.52|0.68|||Fisher Exact|||The efficacy of the treatment was confirmed if H0 was rejected at a given α of 5%, that means if the two sided p-value was ≤0.05. Power of 90%||0.68|0.52|<0.0001
71864399|NCT01294397|143243631|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.96|||||TWO_SIDED|90.0|0.85|1.08|||||Two one-sided tests|Log-transformed AUC0-168 was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.08|0.85|
71864400|NCT01294397|143243632|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio of Day 22/Day 1|0.92|||||TWO_SIDED|90.0|0.81|1.05|||||Two one-sided tests|Log-transformed Cmax was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.||1.05|0.81|
71864401|NCT04421950|143243700|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71864402|NCT01725126|143243758|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.19|||||TWO_SIDED|95.0|-1.38|1.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.||1.75|-1.38|
71864403|NCT01725126|143243758|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.08|||||TWO_SIDED|95.0|-0.2|2.36|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.||2.36|-0.20|
71864404|NCT01725126|143243759|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.11|||||TWO_SIDED|95.0|-1.64|1.87|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.||1.87|-1.64|
71882519|NCT01505634|143284130|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-5.5|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs||2.8|-5.5|
71910262|NCT05109702|143341649|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.096||0.837|TWO_SIDED|95.0|-0.208|0.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.168|-0.208|0.837
71910263|NCT05109702|143341650|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.686|TWO_SIDED|95.0|-0.123|0.187|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.123|0.686
71910264|NCT05109702|143341650|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.079||0.68|TWO_SIDED|95.0|-0.123|0.188|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.188|-0.123|0.680
71864405|NCT01725126|143243759|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-0.24|2.75|||ANCOVA|Repeated measures analysis of variance was used with terms for treatment, visit, treatment by visit interaction and Baseline.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.||2.75|-0.24|
71864406|NCT01725126|143243760|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-1.694|1.331|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||1.331|-1.694|
71864407|NCT01725126|143243760|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.356|||||TWO_SIDED|95.0|-1.409|0.698|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.698|-1.409|
71864408|NCT01725126|143243760|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.853|||||TWO_SIDED|95.0|-2.232|0.526|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.||0.526|-2.232|
71864409|NCT01725126|143243760|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-1.219|||||TWO_SIDED|95.0|-2.447|0.009|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.||0.009|-2.447|
71864410|NCT01725126|143243761|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.155|||||TWO_SIDED|95.0|-1.277|1.587|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B -Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.||1.587|-1.277|
71864411|NCT01725126|143243761|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.524|||||TWO_SIDED|95.0|-1.939|0.892|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.||0.892|-1.939|
71864412|NCT01725126|143243763|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.065|||||TWO_SIDED|95.0|-0.495|0.365|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.||0.365|-0.495|
71864413|NCT01725126|143243763|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.219|||||TWO_SIDED|95.0|-0.91|0.472|||ANCOVA|Terms for treatment and Baseline were included in the model.|Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.||0.472|-0.910|
71864414|NCT01725126|143243767|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.046|||||TWO_SIDED|90.0|0.729|1.5008|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.5008|0.7290|
71682004|NCT02542293|142881906|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.748|1.388|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.388|0.748|
71682005|NCT02542293|142881906|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.36|1.219|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"PD-L1-negative analysis set:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.219|0.360|
71682006|NCT02542293|142881906|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.845|1.147|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\>= 25% Vs \< 25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.|"FAS:~Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.147|0.845|
71682007|NCT02542293|142881906|OTHER|The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.|Hazard Ratio (HR)|0.71|||||TWO_SIDED|95.0|0.492|1.03|||||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.|"FAS:~China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy~A HR \<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC."||1.030|0.492|
71682008|NCT01458951|142881915|SUPERIORITY_OR_OTHER||Percentage difference|13.0||||0.0005|TWO_SIDED|95.0|8.1|17.9|||CMH Chi-square Test|||P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).||17.9|8.1|0.0005
71682009|NCT01458951|142881916|SUPERIORITY_OR_OTHER||Percentage difference|16.8||||0.0002|TWO_SIDED|95.0|9.5|24.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||24.1|9.5|0.0002
71682010|NCT01458951|142881917|SUPERIORITY_OR_OTHER||Percentage difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||36.0|16.8|<0.0001
71682011|NCT01458951|142881918|SUPERIORITY_OR_OTHER||Percentage difference|5.2||||0.0425|TWO_SIDED|95.0|1.8|8.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||8.6|1.8|0.0425
71682012|NCT01458951|142881919|SUPERIORITY_OR_OTHER||Difference in percentage|13.2||||0.0004|TWO_SIDED|95.0|8.3|18.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||18.1|8.3|0.0004
71682013|NCT01458951|142881920|SUPERIORITY_OR_OTHER||Percentage difference|8.0||||0.009|TWO_SIDED|95.0|3.9|12.2|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||12.2|3.9|0.0090
71682014|NCT01458951|142881921|SUPERIORITY_OR_OTHER||Percentage difference|3.3||||0.1408|TWO_SIDED|95.0|0.1|6.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.||6.6|0.1|0.1408
71682015|NCT01458951|142881923|SUPERIORITY_OR_OTHER||Least square mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.6|-1.4|<0.0001
71682016|NCT01458951|142881923|SUPERIORITY_OR_OTHER||Least square mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.7|-1.6|<0.0001
71682017|NCT01458951|142881923|SUPERIORITY_OR_OTHER||Least square mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.7|-0.9|||Mixed Models Analysis|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.||-0.9|-1.7|<0.0001
71682018|NCT01458951|142881924|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||ANCOVA|||The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.||-1.0|-2.2|<0.0001
71864415|NCT01725126|143243768|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.0334|||||TWO_SIDED|90.0|0.781|1.3673|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.||1.3673|0.7810|
71864416|NCT01725126|143243770|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.675|||||TWO_SIDED|90.0|0.585|0.779|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.779|0.585|
71864417|NCT01725126|143243771|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.662|||||TWO_SIDED|90.0|0.578|0.757|||Mixed Models Analysis|The PK parameter was log-transformed prior to analysis.|The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.||0.757|0.578|
71864418|NCT01128270|143243776|SUPERIORITY_OR_OTHER||Mean of one group (2A)|1.64|STANDARD_DEVIATION|0.4|||TWO_SIDED|95.0|1.31|1.97||||Analysis applies only to Arm 2A. (Period 3)|Only arm 2A is relevant to this variable. There is no intended statistical comparison, but the point estimate for the mean level and 95% confidence interval are provided.|No comparison is relevant. The statistical method is how we obtained the point estimate and confidence interval. No test was intended.||1.97|1.31|
71864419|NCT01128270|143243777|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2432.0|STANDARD_DEVIATION|1403.0||0.0017|TWO_SIDED|95.0|1260.0|3606.0|||t-test, 2 sided|||Only relevant to Arm 2B.||3606|1260|0.0017
71864420|NCT01128270|143243778|SUPERIORITY_OR_OTHER||Mean|0.38|STANDARD_DEVIATION|0.17|||TWO_SIDED|95.0|0.24|0.51||||||Only relevant for arm 2B||0.51|0.24|
71864421|NCT03296800|143243780|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|118.66|||||TWO_SIDED|90.0|111.12|126.72|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||126.72|111.12|
71864422|NCT03296800|143243780|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|119.62|||||TWO_SIDED|90.0|94.39|151.59||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|151.59|94.39|
71864423|NCT03296800|143243780|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|106.05|||||TWO_SIDED|90.0|88.81|126.65||||||Geometric LS Mean was used as PK parameters|Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|126.65|88.81|
71864424|NCT03296800|143243783|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|140.98|||||TWO_SIDED|90.0|131.39|151.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||151.26|131.39|
71864425|NCT03296800|143243783|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|86.12|||||TWO_SIDED|90.0|70.24|105.59|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||105.59|70.24|
71864426|NCT03296800|143243783|EQUIVALENCE|The acceptance range for bioequivalence is 80.0 - 125.00%.|Point Estimate (%)|97.93|||||TWO_SIDED|90.0|90.26|106.26|||||Point Estimate is the estimated ratio of exponentiated mean difference of log-transformed PK parameter from ANOVA. Confidence interval is obtained from ANOVA with treatment as a fixed effect, and subject as a random effect.|Geometric LS Mean was used as PK parameters||106.26|90.26|
71864427|NCT02224703|143243838|SUPERIORITY||Treatment Ratio|0.743||||0.0299|TWO_SIDED|95.0|0.568|0.971|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.971|0.568|0.0299
71882520|NCT01505634|143284131|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-4.4|6.8|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||6.8|-4.4|
71882521|NCT01505634|143284131|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-6.1|3.7|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs||3.7|-6.1|
71882522|NCT01505634|143284132|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||TWO_SIDED|95.0|-3.6|6.2|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||6.2|-3.6|
71882523|NCT01505634|143284132|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs||4.6|-4.5|
71882524|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||TWO_SIDED|95.0|-5.5|7.8|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||7.8|-5.5|
71882525|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea||3.6|-8.1|
71864428|NCT02224703|143243838|SUPERIORITY||Treatment Ratio|0.702||||0.0095|TWO_SIDED|95.0|0.538|0.916|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.||0.916|0.538|0.0095
71864429|NCT02224703|143243839|SUPERIORITY||Treatment Ratio|0.749||||0.0255|TWO_SIDED|95.0|0.581|0.965|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.965|0.581|0.0255
71864430|NCT02224703|143243839|SUPERIORITY||Treatment Ratio|0.62||||0.0003|TWO_SIDED|95.0|0.481|0.799|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.||0.799|0.481|0.0003
71864431|NCT02224703|143243840|SUPERIORITY||Odds Ratio (OR)|2.74||||0.0069|TWO_SIDED|95.0|1.32|5.7|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||5.70|1.32|0.0069
71864432|NCT02224703|143243840|SUPERIORITY||Odds Ratio (OR)|2.21||||0.0332|TWO_SIDED|95.0|1.06|4.62|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-12, and 13-18 years).||||4.62|1.06|0.0332
71864433|NCT02224703|143243841|SUPERIORITY||Odds Ratio (OR)|2.02||||0.0279|TWO_SIDED|95.0|1.08|3.78|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||3.78|1.08|0.0279
71864434|NCT02224703|143243841|SUPERIORITY||Odds Ratio (OR)|2.93||||0.0009|TWO_SIDED|95.0|1.56|5.53|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.|||5.53|1.56|0.0009
71864435|NCT03596762|143243846|SUPERIORITY||Difference in LS means|-1.52|||=|0.1946|TWO_SIDED|95.0|-3.83|0.78|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.78|-3.83|= 0.1946
71864436|NCT03596762|143243846|SUPERIORITY||Difference in LS means|1.29|||=|0.3682|TWO_SIDED|95.0|-4.11|1.53|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||1.53|-4.11|= 0.3682
71864437|NCT03596762|143243846|SUPERIORITY||Difference in LS means|-3.93|||=|0.0002|TWO_SIDED|95.0|-5.94|-1.92|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-1.92|-5.94|= 0.0002
71864438|NCT03596762|143243846|SUPERIORITY||Difference in LS means|-2.63|||=|0.0115|TWO_SIDED|95.0|-4.66|-0.6|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||-0.6|-4.66|= 0.0115
71864439|NCT03596762|143243847|SUPERIORITY||Difference in LS means|-1.67|||=|0.2097|TWO_SIDED|95.0|-4.28|-0.95|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.95|-4.28|= 0.2097
71864440|NCT03596762|143243847|SUPERIORITY||Difference in LS means|-0.77|||=|0.6369|TWO_SIDED|95.0|-3.97|2.44|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||2.44|-3.97|= 0.6369
71864441|NCT03596762|143243847|SUPERIORITY||Difference in LS means|-2.95|||=|0.0116|TWO_SIDED|95.0|-5.22|-0.67|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||-0.67|-5.22|= 0.0116
71864442|NCT03596762|143243847|SUPERIORITY||Difference in LS means|-1.78|||=|0.1346|TWO_SIDED|95.0|-4.12|0.56|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.56|-4.12|= 0.1346
71922138|NCT03091920|143364998|OTHER|No statistical testing was performed.|Least squares mean difference|-4.23|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.55|1.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.10|-9.55|
71864443|NCT03596762|143243848|SUPERIORITY||Difference in LS means|-0.05|||=|0.7033|TWO_SIDED|95.0|-0.3|0.2|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.2|-0.3|= 0.7033
71864444|NCT03596762|143243848|SUPERIORITY||Difference in LS means|-0.14|||=|0.3724|TWO_SIDED|95.0|-0.45|0.17|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.17|-0.45|= 0.3724
71864445|NCT03596762|143243848|SUPERIORITY||Difference in LS means|-0.19|||=|0.0896|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.0896
71864446|NCT03596762|143243848|SUPERIORITY||Difference in LS means|-0.19|||=|0.09|TWO_SIDED|95.0|-0.41|0.03|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 4||0.03|-0.41|= 0.09
71864447|NCT03596762|143243849|SUPERIORITY||Difference in LS means|-0.09|||=|0.5511|TWO_SIDED|95.0|-0.39|0.21|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.21|-0.39|= 0.5511
71864448|NCT03596762|143243849|SUPERIORITY||Difference in LS means|0.16|||=|0.3822|TWO_SIDED|95.0|-0.2|0.52|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.52|-0.2|= 0.3822
71864449|NCT03596762|143243849|SUPERIORITY||Difference in LS means|-0.15|||=|0.2606|TWO_SIDED|95.0|-0.41|0.11|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0.11|-0.41|= 0.2606
71864450|NCT03596762|143243849|SUPERIORITY||Difference in LS means|-0.27|||=|0.0479|TWO_SIDED|95.0|-0.53|0.0|||Mixed-Effect Model Repeated Measures|||Change from Baseline to Week 12||0|-0.53|= 0.0479
71864451|NCT00895895|143243904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.424|TWO_SIDED|95.0|-1.0|2.3|||Mixed Models Analysis|Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(\*)visit visit treatment treatment\*visit.||Analysis of adjusted difference in change from baseline.||2.3|-1.0|0.424
71864452|NCT00895895|143243904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.849|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-1.8|0.849
71864453|NCT00895895|143243904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.2|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.2|0.520
71864454|NCT00895895|143243904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.258|TWO_SIDED|95.0|-2.6|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-2.6|0.258
71864455|NCT00895895|143243905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.367|TWO_SIDED|95.0|-5.2|1.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.9|-5.2|0.367
71864456|NCT00895895|143243905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.91|TWO_SIDED|95.0|-3.3|3.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.7|-3.3|0.910
71864457|NCT00895895|143243905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.16|TWO_SIDED|95.0|-1.0|6.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.0|-1.0|0.160
71864458|NCT00895895|143243905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.06|TWO_SIDED|95.0|-0.1|6.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.9|-0.1|0.060
71864459|NCT00895895|143243906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.931|TWO_SIDED|95.0|-2.8|3.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||3.1|-2.8|0.931
71864460|NCT00895895|143243906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9||||0.054|TWO_SIDED|95.0|-5.8|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-5.8|0.054
71864461|NCT00895895|143243906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.246|TWO_SIDED|95.0|-4.6|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.6|0.246
71864462|NCT00895895|143243906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.426|TWO_SIDED|95.0|-4.1|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-4.1|0.426
71864463|NCT00895895|143243907|SUPERIORITY_OR_OTHER|||||||0.265|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.265
71864464|NCT00895895|143243907|SUPERIORITY_OR_OTHER|||||||0.682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.682
71864465|NCT00895895|143243907|SUPERIORITY_OR_OTHER|||||||0.532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.532
71864466|NCT00895895|143243907|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.087
71864467|NCT00895895|143243907|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.751
71864468|NCT00895895|143243908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.553|TWO_SIDED|95.0|-3.9|7.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.3|-3.9|0.553
71864469|NCT00895895|143243908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.886|TWO_SIDED|95.0|-6.0|5.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||5.2|-6.0|0.886
71864470|NCT00895895|143243908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.712|TWO_SIDED|95.0|-6.6|4.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||4.5|-6.6|0.712
71864471|NCT00895895|143243908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8||||0.785|TWO_SIDED|95.0|-4.8|6.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||6.4|-4.8|0.785
71864472|NCT00895895|143243909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.251|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.1|-0.5|0.251
71864473|NCT00895895|143243909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.993|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-0.3|0.993
71864474|NCT00895895|143243909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.553|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.553
71864475|NCT00895895|143243909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.611|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-0.4|0.611
71864476|NCT00895895|143243910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.34|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-1.5|0.340
71864477|NCT00895895|143243910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.63|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.630
71864478|NCT00895895|143243910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.678|TWO_SIDED|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-0.8|0.678
71864479|NCT00895895|143243910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.518|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.3|0.518
71682019|NCT03309696|142881946|EQUIVALENCE|A p value of \<.0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.59||||0.055|TWO_SIDED|||||The p value is not adjusted because it was a planned contrast.|Mixed Models Analysis||Active tDCS - sham tDCS.|Examines the effect of tDCS preconditioning on P100 amplitudes. The effect size for this comparison was .33 (Cohen's).||||.055
71682020|NCT03309696|142881946|EQUIVALENCE|A p value of \<.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|0.36||||0.0418|TWO_SIDED|||||This p value is not adjusted for multiple comparisons because it was a planned contrast.|Mixed Models Analysis||Sham tDCS - Sham tDCS and Active rTMS|Examines the effect of rTMS on the P100 amplitude. The calculated effect size is .35 (Cohen's).||||0.0418
71682021|NCT03309696|142881946|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.19||||0.4|TWO_SIDED|||||The p value is not adjusted as this was a planned contrast.|Mixed Models Analysis||Effect of tDCS preconditioning on active rTMS: active tDCS preconditioning of active rTMS - sham tDCS preconditioning of active rTMS.|Examines the additive effect of tDCS preconditioning on the P100 amplitude after rTMS. The effect size for this comparison was 0.14.||||0.40
71682022|NCT03309696|142881946|EQUIVALENCE|A p value less than 0.05 is taken as evidence of nonequivalence.|Mean Difference (Net)|-0.48||||0.086|TWO_SIDED|||||The p value was not adjusted for this planned contrast.|Mixed Models Analysis||Active tDCS and Active rTMS - Sham tDCS and Sham rTMS.|Examines the combined effect of tDCS and rTMS on the P100 amplitude. The effect size for this comparison was .29 (Cohen's).||||.086
71682023|NCT01573767|142881947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4||||0.227|TWO_SIDED|95.0|-2.7|11.4||Inference for VI 12.5 µg versus (vs) placebo was dependent upon statistical significance (SS) having first been achieved for VI 25 µg vs placebo; inference for VI 6.25 µg vs placebo was dependent on SS having been achieved for VI 12.5 µg vs placebo.|ANCOVA|||||11.4|-2.7|0.227
71682024|NCT01573767|142881947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.073|TWO_SIDED|95.0|-0.6|13.5|||ANCOVA|||||13.5|-0.6|0.073
71682025|NCT01573767|142881947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5||||0.127|TWO_SIDED|95.0|-1.6|12.5|||ANCOVA|||||12.5|-1.6|0.127
71682026|NCT01573767|142881948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.057|||||TWO_SIDED|95.0|-0.138|0.024||||||||0.024|-0.138|
71682027|NCT01573767|142881948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.063|0.096||||||||0.096|-0.063|
71682028|NCT01573767|142881948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.051||||||||0.051|-0.110|
71682029|NCT01573767|142881949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.3|||||TWO_SIDED|95.0|-10.5|6.0||||||||6.0|-10.5|
71682030|NCT01573767|142881949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-6.9|9.6||||||||9.6|-6.9|
71864480|NCT00895895|143243911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.953|TWO_SIDED|95.0|-0.7|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-0.7|0.953
71682031|NCT01573767|142881949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|||||TWO_SIDED|95.0|0.4|17.0||||||||17.0|0.4|
71682032|NCT01573767|142881950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.5|||||TWO_SIDED|95.0|-1.2|12.3||||||||12.3|-1.2|
71682033|NCT01573767|142881950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|||||TWO_SIDED|95.0|0.7|14.2||||||||14.2|0.7|
71682034|NCT01573767|142881950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2||||||95.0|0.4|14.0||||||||14.0|0.4|
71682035|NCT01573767|142881951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|||||TWO_SIDED|95.0|-6.1|13.1||||||||13.1|-6.1|
71682036|NCT01573767|142881951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.8|17.4||||||||17.4|-1.8|
71682037|NCT01573767|142881951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.2|||||TWO_SIDED|95.0|-4.4|14.9||||||||14.9|-4.4|
71682038|NCT01573767|142881952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|-3.7|15.6||||||||15.6|-3.7|
71682039|NCT01573767|142881952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.7|||||TWO_SIDED|95.0|0.0|19.3||||||||19.3|0.0|
71682040|NCT01573767|142881952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0||||||95.0|-2.7|16.7||||||||16.7|-2.7|
71682041|NCT01573767|142881953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-7.2|7.5||||||||7.5|-7.2|
71682042|NCT01573767|142881953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3|||||TWO_SIDED|95.0|1.0|15.7||||||||15.7|1.0|
71682043|NCT01573767|142881953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|2.3|17.2||||||||17.2|2.3|
71758547|NCT02205736|143019222|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 14 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
71864481|NCT00895895|143243911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.956|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.6|-0.7|0.956
71864482|NCT00895895|143243911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.216|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.1|0.216
71758548|NCT02205736|143019222|SUPERIORITY|||||||0.6547||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 15 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.6547
71864483|NCT00895895|143243911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.665|TWO_SIDED|95.0|-0.8|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.5|-0.8|0.665
71864484|NCT00895895|143243912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.373|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.6|0.373
71864485|NCT00895895|143243912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.781|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.3|-1.0|0.781
71864486|NCT00895895|143243912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.417|TWO_SIDED|95.0|-0.7|1.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.6|-0.7|0.417
71864487|NCT00895895|143243912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.853|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.0|-1.3|0.853
71864488|NCT00895895|143243913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.428|TWO_SIDED|95.0|-2.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-2.6|0.428
71864489|NCT00895895|143243913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.763|TWO_SIDED|95.0|-2.1|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.5|-2.1|0.763
71864490|NCT00895895|143243913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.312|TWO_SIDED|95.0|-2.7|0.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.9|-2.7|0.312
71864491|NCT00895895|143243913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.215|TWO_SIDED|95.0|-3.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-3.0|0.215
71864492|NCT00895895|143243914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.956|TWO_SIDED|95.0|-2.7|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.7|0.956
71864493|NCT00895895|143243914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-2.6|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.5|-2.6|0.988
71864494|NCT00895895|143243914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.89|TWO_SIDED|95.0|-2.7|2.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||2.4|-2.7|0.890
71864495|NCT00895895|143243914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.28|TWO_SIDED|95.0|-4.0|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.2|-4.0|0.280
71864496|NCT00895895|143243915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.154|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.2|-1.5|0.154
71864497|NCT00895895|143243915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.74|TWO_SIDED|95.0|-1.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.7|-1.0|0.740
71864498|NCT00895895|143243915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.179|TWO_SIDED|95.0|-1.4|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||0.3|-1.4|0.179
71864499|NCT00895895|143243915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.543|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-0.6|0.543
71864500|NCT00895895|143243916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.4||||0.861|TWO_SIDED|95.0|-739.7|618.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||618.8|-739.7|0.861
71864501|NCT00895895|143243916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-926.6||||0.007|TWO_SIDED|95.0|-1596.9|-256.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-256.3|-1596.9|0.007
71864502|NCT00895895|143243916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|141.3||||0.676|TWO_SIDED|95.0|-522.1|804.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||804.6|-522.1|0.676
71864503|NCT00895895|143243916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|230.6||||0.505|TWO_SIDED|95.0|-449.7|910.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||910.9|-449.7|0.505
71864504|NCT00895895|143243917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8||||0.267|TWO_SIDED|95.0|-2.2|7.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.8|-2.2|0.267
71864505|NCT00895895|143243917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.6||||0.145|TWO_SIDED|95.0|-1.3|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.3|0.145
71864506|NCT00895895|143243917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.139|TWO_SIDED|95.0|-1.2|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||8.6|-1.2|0.139
71864507|NCT00895895|143243917|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2||||0.386|TWO_SIDED|95.0|-2.8|7.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||7.2|-2.8|0.386
71864508|NCT00895895|143243918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2||||0.032|TWO_SIDED|95.0|-2.3|-0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||-0.1|-2.3|0.032
71864509|NCT00895895|143243918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.264|TWO_SIDED|95.0|-0.5|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.7|-0.5|0.264
71864510|NCT00895895|143243918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.893|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.1|-1.0|0.893
71864511|NCT00895895|143243918|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.525|TWO_SIDED|95.0|-0.7|1.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||1.4|-0.7|0.525
71864512|NCT00895895|143243919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|60.9||||0.056|TWO_SIDED|95.0|-1.6|123.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||123.5|-1.6|0.056
71864513|NCT00895895|143243919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.8||||0.488|TWO_SIDED|95.0|-40.0|83.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||83.5|-40.0|0.488
71864514|NCT00895895|143243919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6||||0.783|TWO_SIDED|95.0|-52.6|69.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||69.8|-52.6|0.783
71864515|NCT00895895|143243919|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.578|TWO_SIDED|95.0|-44.6|79.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||79.8|-44.6|0.578
71910265|NCT05109702|143341650|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.08||0.529|TWO_SIDED|95.0|-0.107|0.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.207|-0.107|0.529
71864516|NCT00895895|143243920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.1||||0.175|TWO_SIDED|95.0|-13.9|76.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||76.1|-13.9|0.175
71864517|NCT00895895|143243920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.0||||0.352|TWO_SIDED|95.0|-23.3|65.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.4|-23.3|0.352
71864518|NCT00895895|143243920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.797|TWO_SIDED|95.0|-38.1|49.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||49.6|-38.1|0.797
71864519|NCT00895895|143243920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.9||||0.633|TWO_SIDED|95.0|-55.6|33.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||33.9|-55.6|0.633
71864520|NCT00895895|143243921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.2||||0.066|TWO_SIDED|95.0|-4.7|147.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||147.0|-4.7|0.066
71864521|NCT00895895|143243921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0||||0.598|TWO_SIDED|95.0|-54.6|94.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||94.7|-54.6|0.598
71864522|NCT00895895|143243921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.766|TWO_SIDED|95.0|-62.9|85.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.3|-62.9|0.766
71864523|NCT00895895|143243921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.8||||0.378|TWO_SIDED|95.0|-41.5|109.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||109.1|-41.5|0.378
71864524|NCT00895895|143243922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.5||||0.481|TWO_SIDED|95.0|-40.2|85.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||85.2|-40.2|0.481
71864525|NCT00895895|143243922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.894|TWO_SIDED|95.0|-57.5|65.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||65.9|-57.5|0.894
71864526|NCT00895895|143243922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.991|TWO_SIDED|95.0|-61.5|60.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||60.8|-61.5|0.991
71864527|NCT00895895|143243922|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.5||||0.422|TWO_SIDED|95.0|-87.9|36.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline \* visit visit treatment treatment \* visit.||Analysis of adjusted difference in change from baseline.||36.9|-87.9|0.422
71864528|NCT00895895|143243923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.581|TWO_SIDED|95.0|0.24|2.22|||Regression, Logistic|||||2.22|0.24|0.581
71864529|NCT00895895|143243923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.77|TWO_SIDED|95.0|0.42|3.19|||Regression, Logistic|||||3.19|0.42|0.770
71864530|NCT00895895|143243923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.216|TWO_SIDED|95.0|0.71|4.55|||Regression, Logistic|||||4.55|0.71|0.216
71864531|NCT00895895|143243923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61||||0.037|TWO_SIDED|95.0|1.06|6.42|||Regression, Logistic|||||6.42|1.06|0.037
71864532|NCT00504777|143243925|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71864533|NCT00504777|143243928|SUPERIORITY_OR_OTHER|||||||0.0054|||||||t-test, 2 sided|||||||0.0054
71864534|NCT03995316|143243932|SUPERIORITY||Slope|-0.76|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.003
71864535|NCT03995316|143243933|SUPERIORITY||Slope|-0.18|STANDARD_ERROR_OF_MEAN|0.17||0.283|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.283
71864536|NCT03995316|143243934|SUPERIORITY||Slope|-0.51|STANDARD_ERROR_OF_MEAN|0.22||0.019|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.019
71864537|NCT03995316|143243935|SUPERIORITY||Slope|0.34|STANDARD_ERROR_OF_MEAN|0.44||0.44|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.440
71864538|NCT03995316|143243936|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.055|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.055
71864539|NCT03995316|143243937|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.041|TWO_SIDED||||||t-test, 2 sided||The slope value reflects the mean difference between conditions in the linear slope from the pretest to posttest assessment.|||||.041
71864540|NCT03197766|143243977|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analysis for the primary endpoint.|ANCOVA|Two subjects in the BMN 111 group discontinued from the study before Week 52. The values for these 2 subjects were imputed for this analysis.||||||< 0.0001
71864541|NCT03197766|143243978|SUPERIORITY||||||<|0.0001||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||< 0.0001
71864542|NCT03197766|143243979|SUPERIORITY||||||=|0.506||||||Confirmatory statistical testing controlling for the Type I error rate was performed on the primary analyses for the two key secondary endpoints.|ANCOVA|Missing assessments at Week 52 were imputed||||||= 0.506
71864543|NCT00672737|143243981|SUPERIORITY_OR_OTHER||Slope|0.0025|||<|0.05|TWO_SIDED|95.0|0.0009|0.0041|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level the cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0041|0.0009|<0.05
71864544|NCT00672737|143243981|SUPERIORITY_OR_OTHER||Slope|-0.9694||||0.05|TWO_SIDED|95.0|-1.9127|-0.0261|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2 the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0261|-1.9127|0.05
71864545|NCT00672737|143243982|SUPERIORITY_OR_OTHER||Slope|-0.0001|||<|0.05|TWO_SIDED|95.0|-0.0001|-0.0001|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||-0.0001|-0.0001|<0.05
71864546|NCT00672737|143243982|SUPERIORITY_OR_OTHER||Slope|-0.0172|||<|0.05|TWO_SIDED|95.0|-0.018|0.0556|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.||0.0556|-0.018|<0.05
71882526|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||TWO_SIDED|95.0|-6.4|6.5|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||6.5|-6.4|
71864547|NCT01460225|143243988|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.003|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal||||0.003
71864548|NCT01460225|143243988|EQUIVALENCE|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.122|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal||||0.122
71864549|NCT03852719|143244011|OTHER||Difference in percentages|46.0|||<|0.0001|TWO_SIDED|96.0|30.5|61.4||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||61.4|30.5|<0.0001
71864550|NCT03852719|143244011|OTHER||Difference in percentages|42.9|||<|0.0001|TWO_SIDED|96.0|27.0|58.5||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed Treatment using a significance level of 0.04 at Week 48.|Fisher Exact|||||58.5|27.0|<0.0001
71864551|NCT03852719|143244012|OTHER||Difference in percentages|7.8||||0.4139|TWO_SIDED|96.0|-8.5|24.3||Fisher's exact test was used for the comparison of bulevirtide 10 mg versus bulevirtide 2 mg using a significance level of 0.04 at Week 48.|Fisher Exact|||||24.3|-8.5|0.4139
71864552|NCT03852719|143244013|OTHER||Difference in percentages|39.3|||<|0.0001|TWO_SIDED|95.0|20.0|55.8||Fisher's exact test was used for comparison of bulevirtide 2 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||55.8|20.0|<0.0001
71864553|NCT03852719|143244013|OTHER||Difference in percentage|44.2|||<|0.0001|TWO_SIDED|95.0|25.8|59.9||Fisher's exact test was used for comparison of bulevirtide 10 mg versus Delayed treatment using a significance level of 0.05.|Fisher Exact|||||59.9|25.8|<0.0001
71864554|NCT03852719|143244014|OTHER||Difference in LS Mean|-4.02||||0.001|TWO_SIDED|95.0|-6.39|-1.65|||ANCOVA|||||-1.65|-6.39|0.0010
71910266|NCT05109702|143341650|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.081||0.745|TWO_SIDED|95.0|-0.132|0.185|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.185|-0.132|0.745
71910267|NCT05109702|143341651|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.085||0.765|TWO_SIDED|95.0|-0.141|0.192|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.192|-0.141|0.765
71864555|NCT03852719|143244014|OTHER||Difference in LS Mean|-3.93||||0.0009|TWO_SIDED|95.0|-6.23|-1.63|||ANCOVA|||||-1.63|-6.23|0.0009
71864556|NCT03852719|143244015|OTHER||Difference in Least Square (LS) Mean|0.57||||0.5156|TWO_SIDED|95.0|-1.16|2.3|||MMRM|||||2.30|-1.16|0.5156
71864557|NCT03852719|143244016|OTHER||Difference in Least Square (LS) Mean|-1.21||||0.2977|TWO_SIDED|95.0|-3.5|1.08|||MMRM|||||1.08|-3.50|0.2977
71864558|NCT03852719|143244017|SUPERIORITY||LS-Mean of Diffrence|-0.04||||0.9719|TWO_SIDED|95.0|-2.23|2.15||P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||2.15|-2.23|0.9719
71864559|NCT03852719|143244018|SUPERIORITY|P-value was based on the mixed-effects model for repeated measurements (MMRM) model.|LS-Mean of Difference|2.11||||0.2369|TWO_SIDED|95.0|-1.41|5.63|||MMRM||Least squares (LS) means, standard errors (SE), 95% CIs and p-values were based on the mixed-effects model for repeated measurements (MMRM) model for change from baseline.|||5.63|-1.41|0.2369
71864560|NCT03852719|143244019|SUPERIORITY||Response Rate Difference|7.6||||0.4695|TWO_SIDED|95.0|-9.6|24.4||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||24.4|-9.6|0.4695
71864561|NCT03852719|143244019|SUPERIORITY||Response Rate Difference|-0.4||||1|TWO_SIDED|95.0|-16.3|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||15.5|-16.3|1.0000
71864562|NCT03852719|143244020|SUPERIORITY||Response Rate Difference|7.7||||0.4539|TWO_SIDED|95.0|-8.8|24.0||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented|||24.0|-8.8|0.4539
71864563|NCT03852719|143244020|SUPERIORITY||Response Rate Difference|-0.3||||1|TWO_SIDED|95.0|-15.6|15.5||P-value was based on Fisher's Exact Test.|Fisher Exact||For response rate difference, the 95% exact unconditional confidence interval (CI) based on the score statistic was presented.|||15.5|-15.6|1.0000
71864564|NCT02819024|143244032|OTHER|||||||0.087|||||||t-test, 2 sided|||||||0.087
71864565|NCT05472740|143244041|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71864566|NCT03832595|143244051|EQUIVALENCE|We determined that 1,653 patients provide 80% power to detect a hazard ratio of 0.64, or a 5% absolute risk reduction in intervention arm, assuming a primary end-point rate of 15% in the usual care group at 24 months, 20% loss to follow-up, α = 0.05, and within-practice intra-class correlation of 0.01|Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38|||Mixed Models Analysis|||||1.38|0.67|0.82
71864567|NCT03832595|143244052|EQUIVALENCE|α = 0.05|Slope difference|0.011|||||TWO_SIDED|95.0|-0.008|0.029||||||||0.029|-0.008|
71758549|NCT02205736|143019222|SUPERIORITY|||||||0.1797||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 16 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.1797
71864568|NCT03832595|143244053|EQUIVALENCE|α = 0.05|Rate ratio|1.21|||||TWO_SIDED|95.0|1.02|1.43||||||||1.43|1.02|
71864569|NCT03832595|143244054|EQUIVALENCE|α = 0.05|Rate ratio|0.8|||||TWO_SIDED|95.0|0.51|1.25||||||||1.25|0.51|
71864570|NCT03832595|143244055|EQUIVALENCE|α = 0.05|Rate ratio|1.18|||||TWO_SIDED|95.0|0.03|53.78||||||||53.78|0.03|
71864571|NCT03832595|143244056|EQUIVALENCE|α = 0.05|Rate ratio|1.12|||||TWO_SIDED|95.0|0.12|9.96||||||||9.96|0.12|
71864572|NCT03238963|143244103|OTHER||Risk Difference (RD)|0.057|STANDARD_ERROR_OF_MEAN|0.039|||TWO_SIDED|95.0|-0.053|0.192|||Chan and Zhang method|95% confidence interval was calculating using the Chan and Zhang method.|Risk difference of BI 1467335 10 milligram (mg) group minus Placebo group.|||0.192|-0.053|
71864573|NCT03031496|143244139|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|91.52|||||TWO_SIDED|90.0|87.77|95.43|||||Comparison of AUC (0-t) of hydrochlorothiazide for test and reference product has been presented.|||95.43|87.77|
71864574|NCT03031496|143244139|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|102.42|||||TWO_SIDED|90.0|98.12|106.91|||||Comparison of AUC (0-t) of amiloride for test and reference product has been presented.|||106.91|98.12|
71864575|NCT03031496|143244140|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|82.86|||||TWO_SIDED|90.0|77.37|88.74|||||Comparison of Cmax of hydrochlorothiazide for test and reference product has been presented.|||88.74|77.37|
71864576|NCT03031496|143244140|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|103.92|||||TWO_SIDED|90.0|97.42|110.86|||||Comparison of Cmax of amiloride for test and reference product has been presented.|||110.86|97.42|
71864577|NCT03031496|143244141|EQUIVALENCE|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|92.37|||||TWO_SIDED|90.0|88.75|96.12|||||Comparison of Tmax of hydrochlorothiazide for test and reference product has been presented.|||96.12|88.75|
71864578|NCT03031496|143244141|OTHER||Least square mean ratio|101.47|||||TWO_SIDED|90.0|97.84|105.23|||||Comparison of Tmax of amiloride for test and reference product has been presented.|||105.23|97.84|
71864579|NCT01254552|143244155|OTHER||rate|0.071|||||TWO_SIDED|95.0|0.043|0.1||||||||0.100|0.043|
71864580|NCT02579135|143244158|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.32|TWO_SIDED||||||Regression, Linear|||Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||.32
71864581|NCT02579135|143244159|SUPERIORITY|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|8.31|STANDARD_ERROR_OF_MEAN|2.71|<|0.001|TWO_SIDED||||||Regression, Linear|||We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.||||<.001
71864582|NCT01146600|143244160|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|ANOVA, comparing baseline, clarithromycin, and placebo||||||0.47
71864583|NCT01146600|143244161|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.63
71864584|NCT01146600|143244162|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.64
71864585|NCT01146600|143244163|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
71864586|NCT01146600|143244164|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.002
71864587|NCT01146600|143244165|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.01
71864588|NCT01146600|143244166|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo||||||0.76
71864589|NCT01038427|143244292|EQUIVALENCE|If the 90% confidence intervals were contained within the interval 80.0% to 125.0%, then the two products were considered to be therapeutically equivalent.|Ratio Test/Ref. Least Squares (LS) Means|106.644|||||TWO_SIDED|90.0|91.86|123.997||||||||123.997|91.860|
71864590|NCT01038427|143244293|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71864591|NCT01038427|143244293|SUPERIORITY|||||||0.0001|||||||ANCOVA|||||||0.0001
71864592|NCT01038427|143244294|EQUIVALENCE|90% confidence intervals within the interval 80.0% to 125.0%.|Ratio Test/Ref. LS Means|109.716|||||TWO_SIDED|90.0|93.316|129.159||||||||129.159|93.316|
71864593|NCT01038427|143244295|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71864594|NCT01038427|143244295|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71864595|NCT01038427|143244296|SUPERIORITY|||||||0.2655|||||||Cochran-Mantel-Haenszel|||||||0.2655
71864596|NCT01038427|143244296|SUPERIORITY|||||||0.0009|||||||Cochran-Mantel-Haenszel|||||||0.0009
71864597|NCT01038427|143244296|SUPERIORITY|||||||0.1093|||||||Cochran-Mantel-Haenszel|||||||0.1093
71864598|NCT01038427|143244297|SUPERIORITY|||||||0.9915|||||||Cochran-Mantel-Haenszel|||||||0.9915
71864599|NCT01038427|143244297|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
71864600|NCT01038427|143244297|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
71682044|NCT00869557|142881959|NON_INFERIORITY_OR_EQUIVALENCE|"A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA \< 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.~A total of 71 participants were enrolled in the study (4 fewer than planned)."|Difference in the response rates (%)|2.8|||||TWO_SIDED|95.0|-14.5|20.1|||||The 95% confidence interval was computed using normal approximation stratified by baseline HIV-1 RNA stratum (≤ 100,000 or \> 100,000 copies/mL).|The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.||20.1|-14.5|
71864601|NCT00588692|143244301|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||For 25-49% Ejection Fraction Subgroup||||<0.05
71864602|NCT00588692|143244301|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||35-49% Ejection Fraction Subgroup||||<0.05
71864603|NCT00588692|143244303|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANOVA|||||||0.06
71864604|NCT00588692|143244304|SUPERIORITY_OR_OTHER|||||||0.5|||||||ANOVA|||||||0.5
71864605|NCT00588692|143244304|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864606|NCT00588692|143244304|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864607|NCT00588692|143244305|SUPERIORITY_OR_OTHER|||||||0.26|||||||ANOVA|||||||0.26
71864608|NCT00588692|143244305|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864609|NCT00588692|143244305|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864610|NCT00588692|143244306|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
71864611|NCT00588692|143244307|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
71864612|NCT00588692|143244307|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864613|NCT00588692|143244307|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864614|NCT00588692|143244308|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
71864615|NCT00588692|143244309|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
71864616|NCT00588692|143244310|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|||||||0.3
71864617|NCT00588692|143244311|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
71864618|NCT00588692|143244311|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864619|NCT00588692|143244311|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
71864620|NCT00588692|143244312|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANOVA|||||||0.6
71682045|NCT02368210|142881965|SUPERIORITY||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||||||<0.001
71864621|NCT00588692|143244313|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
71864622|NCT00588692|143244313|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864623|NCT00588692|143244313|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864624|NCT00588692|143244314|SUPERIORITY_OR_OTHER|||||||0.11|||||||ANOVA|||||||0.11
71864625|NCT00588692|143244314|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864626|NCT00588692|143244314|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71864627|NCT00588692|143244315|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|||||||0.4
71864628|NCT00588692|143244315|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864629|NCT00588692|143244315|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864630|NCT00588692|143244316|SUPERIORITY_OR_OTHER|||||||0.9|||||||ANOVA|||||||0.9
71864631|NCT00588692|143244316|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71864632|NCT00588692|143244316|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline||||<0.05
71882527|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|2.1|||||TWO_SIDED|95.0|-4.6|9.2|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea||9.2|-4.6|
71882528|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||1.9|-9.0|
71882529|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||TWO_SIDED|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria||3.6|-8.1|
71882530|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
71882531|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||TWO_SIDED|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive||1.9|-9.0|
71882532|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|3.1|||||TWO_SIDED|95.0|-3.7|10.4|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||10.4|-3.7|
71882533|NCT01505634|143284133|OTHER|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||TWO_SIDED|95.0|-7.2|5.1|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache||5.1|-7.2|
71864633|NCT02833077|143244378|SUPERIORITY||Responder Rate Difference|28.85||||0.0019|TWO_SIDED|95.0|11.16|45.6||If the 2-sided p-value is \< 0.05, the responder rate is greater for treatment than for control group, and point estimate of the responder rater for treatment group is greater than 50%, then treatment will be considered superior to control group.|Fisher's exact test|||Superiority of treatment group was established if responder rate at month 6 was statistically greater than that for the control group at month 6 and the observed responder rate at month 6 for the treatment group was greater than 50%.||45.60|11.16|0.0019
71864634|NCT02833077|143244379|OTHER||||||<|0.0001||||||P-value is based on a 2-sided paired t-test at the 5% level to demonstrate that the mean overall satisfaction score at month 6 visit is statistically greater than that at the baseline for the treatment group.|Two sided paired t-test|||||||<.0001
71864635|NCT00972322|143244382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|8.7||0.083|TWO_SIDED|90.0|-29.87|-0.82|||Least Squares Means Difference||Placebo - MK-8245 on Day 28|||-0.82|-29.87|0.083
71864636|NCT01077518|143244385|SUPERIORITY||Stratified Cox propor.hazards regression|0.82||||0.139|TWO_SIDED|95.0|0.62|1.07|||Stratified Log-Rank|||||1.07|0.62|0.1390
71864637|NCT01077518|143244386|OTHER||Stratified Cox propor.hazards regression|0.76||||0.1076|TWO_SIDED|95.0|0.55|1.06|||Stratified Log-Rank|||||1.06|0.55|0.1076
71864638|NCT01077518|143244387|OTHER|||||||0.8003|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for All participants||||0.8003
71864639|NCT01077518|143244388|OTHER|||||||0.613|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for Follicular Lymphoma (FL) participants||||0.6130
71864640|NCT01077518|143244389|OTHER||Hazard Ratio (HR)|0.87||||0.4046|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|||for All patients||1.21|0.62|0.4046
71864641|NCT01077518|143244390|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3768|TWO_SIDED|95.0|0.55|1.25|||Stratified Log Rank|||for FL participants||1.25|0.55|0.3768
71864642|NCT01495598|143244414|OTHER|Other = Kaplan Meier||||||0.43|||||||Log Rank|||||||0.43
71864643|NCT01495598|143244424|OTHER|\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.19||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.19
71864644|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.72||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.72
71864645|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
71864646|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
71864647|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
71864648|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
71864649|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
71910268|NCT05109702|143341651|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.085||0.053|TWO_SIDED|95.0|-0.002|0.331|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.331|-0.002|0.053
71864650|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.06
71864651|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
71864652|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0003||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0003
71910269|NCT05109702|143341651|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.086||0.552|TWO_SIDED|95.0|-0.117|0.219|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.219|-0.117|0.552
71922139|NCT03091920|143364998|OTHER|No statistical testing was performed.|Least squares mean difference|-2.15|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-7.4|3.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.11|-7.40|
71864653|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0002
71864654|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.01||||||The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.01
71864655|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.03
71864656|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.91||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.91
71864657|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.64||||||The reported p-value is representative of the changes in levels of IL10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.64
71864658|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.7||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.70
71864659|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.59||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.59
71864660|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.26||||||The reported p-value is representative of the changes in levels of IL12 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.26
71864661|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0008||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.0008
71864662|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||<0.0001
71864663|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of IL13 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
71864664|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.005||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.005
71864665|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
71910270|NCT05109702|143341651|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.087||0.593|TWO_SIDED|95.0|-0.216|0.124|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.124|-0.216|0.593
71910271|NCT05109702|143341652|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.087||0.884|TWO_SIDED|95.0|-0.183|0.158|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.158|-0.183|0.884
71910272|NCT05109702|143341652|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.474|TWO_SIDED|95.0|-0.109|0.233|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.233|-0.109|0.474
71910273|NCT05109702|143341652|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.088||0.202|TWO_SIDED|95.0|-0.06|0.285|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.285|-0.060|0.202
71864666|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007||||||The reported p-value is representative of the changes in levels of TNFα among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.007
71864667|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.42||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.42
71864668|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.85||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.85
71864669|NCT01495598|143244424|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.16||||||The reported p-value is representative of the changes in levels of IP-10 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.|Wilcoxon signed rank test|||||||0.16
71682046|NCT02368210|142881966|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Scaling.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71682047|NCT02368210|142881966|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: erythema.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71864670|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.07||||||The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.07
71864671|NCT01495598|143244425|NON_INFERIORITY|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.13
71864672|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.15||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.|Wilcoxon signed rank test|||||||0.15
71910274|NCT05109702|143341652|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.089||0.013|TWO_SIDED|95.0|0.047|0.396|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.396|0.047|0.013
71910275|NCT05109702|143341653|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.604|TWO_SIDED|95.0|-0.131|0.224|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.224|-0.131|0.604
71910276|NCT05109702|143341653|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.091||0.519|TWO_SIDED|95.0|-0.119|0.236|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.236|-0.119|0.519
71910277|NCT05109702|143341653|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.092||0.299|TWO_SIDED|95.0|-0.085|0.275|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.275|-0.085|0.299
71922140|NCT03091920|143364998|OTHER|No statistical testing was performed.|Least squares mean difference|-8.74|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-15.64|-1.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.85|-15.64|
71864673|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.03
71922141|NCT03091920|143364998|OTHER|No statistical testing was performed.|Least squares mean difference|-5.34|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|95.0|-11.84|1.15|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.15|-11.84|
71682048|NCT02368210|142881966|SUPERIORITY||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Plaque Elevation.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71864674|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.06
71864675|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.79||||||The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.|Wilcoxon rank sum test|||||||0.79
71864676|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.03||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.03
71910278|NCT05109702|143341653|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.093||0.124|TWO_SIDED|95.0|-0.039|0.324|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.324|-0.039|0.124
71910279|NCT05109702|143341654|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.215||0.293|TWO_SIDED|95.0|-0.196|0.647|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.647|-0.196|0.293
71910280|NCT05109702|143341654|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.215||0.094|TWO_SIDED|95.0|-0.062|0.783|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.783|-0.062|0.094
71910281|NCT05109702|143341654|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.217||0.404|TWO_SIDED|95.0|-0.245|0.608|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.608|-0.245|0.404
71910282|NCT05109702|143341654|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.22||0.806|TWO_SIDED|95.0|-0.485|0.377|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.377|-0.485|0.806
71910283|NCT05109702|143341655|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.157||0.824|TWO_SIDED|95.0|-0.273|0.343|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.343|-0.273|0.824
71910284|NCT05109702|143341655|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.157||0.437|TWO_SIDED|95.0|-0.186|0.431|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.431|-0.186|0.437
71910285|NCT05109702|143341655|SUPERIORITY||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.159||0.193|TWO_SIDED|95.0|-0.105|0.519|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.519|-0.105|0.193
71910286|NCT05109702|143341655|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.161||0.024|TWO_SIDED|95.0|0.048|0.679|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.679|0.048|0.024
71910287|NCT05109702|143341656|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.43|TWO_SIDED|95.0|-0.386|0.907|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.907|-0.386|0.430
71910288|NCT05109702|143341656|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.33||0.143|TWO_SIDED|95.0|-0.164|1.132|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.132|-0.164|0.143
71910289|NCT05109702|143341656|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.333||0.245|TWO_SIDED|95.0|-0.267|1.042|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.042|-0.267|0.245
71910290|NCT05109702|143341656|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.337||0.359|TWO_SIDED|95.0|-0.352|0.97|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.970|-0.352|0.359
71864677|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.008||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.008
71864678|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.12||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.12
71864679|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
71864680|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.02||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.02
71864681|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.|Wilcoxon signed rank test|||||||0.36
71864682|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.002
71864683|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.0002||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||0.0002
71864684|NCT01495598|143244425|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.|||||<|0.0001||||||The reported p-value is representative of the changes in levels of CD19+ cells/µL among all participants.|Wilcoxon signed rank test|||||||<0.0001
71864685|NCT01495598|143244426|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.13|||||||Wilcoxon signed rank test|||||||0.13
71864686|NCT01495598|143244426|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
71864687|NCT01495598|143244426|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.32|||||||Wilcoxon signed rank test|||||||0.32
71864688|NCT01495598|143244426|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.06|||||||Wilcoxon signed rank test|||||||0.06
71864689|NCT01495598|143244426|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.007|||||||Wilcoxon signed rank test|||||||0.007
71864690|NCT01495598|143244427|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
71864691|NCT01495598|143244427|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.65|||||||Wilcoxon signed rank test|||||||0.65
71864692|NCT01495598|143244427|OTHER|P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.||||||0.56|||||||Wilcoxon signed rank test|||||||0.56
71864693|NCT05140915|143244456|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||.77
71864694|NCT03746392|143244488|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
71864695|NCT04777864|143244501|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Parent group only||||0.18
71864696|NCT04777864|143244501|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Adolescent group only||||0.91
71864697|NCT04777864|143244502|SUPERIORITY|||||||0.975|||||||Regression, Linear|||Parent: Post-Index Visit||||0.975
71864698|NCT04777864|143244502|SUPERIORITY|||||||0.854|||||||Regression, Linear|||Adolescent: Post-Index Visit||||0.854
71864699|NCT04777864|143244505|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Post-Index Visit||||0.03
71864700|NCT04777864|143244505|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.21
71864701|NCT04777864|143244506|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Baseline||||0.76
71864702|NCT04777864|143244506|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||Post-Index Visit||||0.96
71864703|NCT04777864|143244506|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||3 months after initial clinic visit||||0.96
71864704|NCT01647542|143244507|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.27|-0.78||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.78|-1.27|<0.001
71864705|NCT01647542|143244507|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.126|<|0.001|TWO_SIDED|95.0|-1.07|-0.57||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was \<=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2-sided significance level of 0.05.||-0.57|-1.07|<0.001
71864706|NCT01647542|143244508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.66|||<|0.001|TWO_SIDED|95.0|2.99|10.72||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||10.72|2.99|<0.001
71864707|NCT01647542|143244508|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001|TWO_SIDED|95.0|1.81|6.49||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.||||6.49|1.81|<0.001
71682049|NCT00078949|142881971|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The literature has suggested that the ORR is approximately 50% for this patient population treated with DHAP. The treatment difference is defined as the response rate for the DHAP arm minus that of GDP arm. We would consider GDP to be non-inferior to DHAP if we are 95% sure that the true difference is less than 10%. In order to rule out that the 10% difference with 80% power, we need to accrue a total of 630 eligible patients. The actual sample size for this final analysis is 619 patients.|Risk Difference (RD)|-1.2||||0.005|TWO_SIDED|95.0|-9.0|6.7||p-value for non-inferiority|Cochran-Mantel-Haenszel|||||6.7|-9.0|0.005
71864708|NCT01647542|143244509|SUPERIORITY_OR_OTHER||Least squares mean difference|-35.6|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.2|-26.9||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value covariate.||||-26.9|-44.2|<0.001
71682050|NCT00078949|142881972|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.1||||0.55||95.0|-10.0|5.8|||Cochran-Mantel-Haenszel|||||5.8|-10.0|0.55
71682051|NCT00078949|142881973|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.17|TWO_SIDED|95.0|0.52|1.12|||Log Rank|||It was estimated that 240 patients will be eligible for the maintenance question, and randomized with a 1:1 ratio to either rituximab or observation. It is expected that the 2-year event-free survival will be 50% on the observation arm. In order to detect a 15% difference in the 2-year event-free survival with an 80% power using a two-sided 5% level test, 142 events are required to detect an HR of 0.622.||1.12|0.52|0.17
71864709|NCT01647542|143244509|SUPERIORITY_OR_OTHER||Least Squares mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-44.3|-27.1||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||||-27.1|-44.3|<0.001
71864710|NCT01647542|143244510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9|STANDARD_ERROR_OF_MEAN|29.72||0.846|TWO_SIDED|95.0|-57.9|69.6||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||69.6|-57.9|0.846
71864711|NCT01647542|143244510|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|30.4||0.427|TWO_SIDED|95.0|-90.1|40.3||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.||||40.3|-90.1|0.427
71864712|NCT03086655|143244511|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.9|1.93|||||This is the 'inflation part' of the zero inflated negative binomial model. We used cluster robust standard errors due to the multiple observations over time being nested within participant. Result shows odds of intervention group relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing a large number of 0. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 1: the odds of having 0 openings is lower in intervention than control group."||1.93|0.90|
71864713|NCT03086655|143244511|SUPERIORITY||incidence rate ratio (IRR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||||This is the negative binomial part of the model. We used cluster robust standard errors due to the multiple observations being nested within participant. Result shows intervention group had lower rate of openings relative to control.|"We used zero inflated negative binomial regression due to the count variable being overdispersed and containing many 0s. The analysis aggregated over multiple time points per participant. It simultaneously tests the odds of having 0 openings and the difference in the rate of openings between the 2 intervention groups. These 2 results are reported separately.~Null hypothesis 2: the incidence rate ratio for # days with box opening is \>1, i.e. more openings in intervention than control group."||0.98|0.61|
71864714|NCT03086655|143244512|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (2 d.f.), simultaneously testing if parameters for both 6 mo. by intervention and 12 mo. by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of undetectable VL as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of undetectable VL will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
71864715|NCT03086655|143244513|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|95.0|-0.11|0.43||a priori threshold for statistical significance was p=0.05.|t-test, 2 sided|(equal variances assumed)|Difference = control group - treatment group|||0.43|-0.11|<0.05
71864716|NCT03086655|143244514|SUPERIORITY|||||||0.08|||||||Chi-squared|overall Wald chi2 (4 d.f.), simultaneously testing if parameters for all follow-ups by intervention are different from 0.||"statistical analyses is a GEE model with logit link function and binomial distribution with odds of optimal adherence as outcome and as predictors: intervention, time and time\*intervention. We hypothesize that over time, the odds of optimal adherence will be higher for the intervention than the control group, which would be reflected in a significant interaction effect time\*intervention.~H0: no significant interaction effect time\*intervention"||||0.08
71864717|NCT05576662|143244516|OTHER||Pooled treatment coefficient|0.026||||0.903|TWO_SIDED|||||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Nonparametric permutation test||Weighted average of treatment coefficients. A pooled treatment coefficient \< 0 favors nirmatrelvir plus ritonavir; a pooled treatment coefficient \> 0 favors placebo plus ritonavir.|A proportional odds logistic regression model was fit for severity of each core symptom at week 10, adjusting for baseline severity of the corresponding symptom and fit using only those who experienced the symptom at baseline. A test statistic for overall efficacy was calculated as the weighted average of the treatment coefficient in the proportional odds model for each symptom with inverse variance weighting. The p-value was obtained by a nonparametric permutation test.||||0.903
71864718|NCT05576662|143244517|OTHER||Odds Ratio (OR)|1.55||||0.174|TWO_SIDED|95.0|0.82|2.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of fatigue score at day 15||2.94|0.82|0.174
71864719|NCT05576662|143244517|OTHER||Odds Ratio (OR)|1.21||||0.548|TWO_SIDED|95.0|0.65|2.25||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of brain fog score at day 15||2.25|0.65|0.548
71864720|NCT05576662|143244517|OTHER||Odds Ratio (OR)|0.62||||0.134|TWO_SIDED|95.0|0.33|1.16||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of dyspnea score at day 15||1.16|0.33|0.134
71922142|NCT03091920|143364999|OTHER|No statistical testing was performed.|Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|95.0|-4.86|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.96|-4.86|
71922143|NCT03091920|143364999|OTHER|No statistical testing was performed.|Least squares mean difference|-0.71|STANDARD_ERROR_OF_MEAN|2.1|||TWO_SIDED|95.0|-5.07|3.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||3.65|-5.07|
71682052|NCT04027075|142882014|SUPERIORITY||Odds Ratio (OR)|1.02||||0.962|TWO_SIDED|95.0|0.51|2.02|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.02|0.51|.962
71682053|NCT04027075|142882015|SUPERIORITY||Odds Ratio (OR)|0.47||||0.109|TWO_SIDED|95.0|0.19|1.18|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||1.18|0.19|.109
71864721|NCT05576662|143244517|OTHER||Odds Ratio (OR)|1.45||||0.241|TWO_SIDED|95.0|0.78|2.69||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of body aches score at day 15||2.69|0.78|0.241
71864722|NCT05576662|143244517|OTHER||Odds Ratio (OR)|1.03||||0.922|TWO_SIDED|95.0|0.55|1.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of gastrointestinal symptoms score at day 15||1.92|0.55|0.922
71864723|NCT05576662|143244517|OTHER||Odds Ratio (OR)|0.5||||0.032|TWO_SIDED|95.0|0.26|0.94||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of cardiovascular symptoms score at day 15||0.94|0.26|0.032
71864724|NCT05576662|143244518|OTHER||Odds Ratio (OR)|0.55||||0.09|TWO_SIDED|95.0|0.27|1.09||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||1.09|0.27|0.09
71682054|NCT04027075|142882016|SUPERIORITY||Odds Ratio (OR)|1.58||||0.227|TWO_SIDED|95.0|0.75|3.29|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.29|0.75|.227
71682055|NCT04027075|142882017|SUPERIORITY||Odds Ratio (OR)|1.2||||0.681|TWO_SIDED|95.0|0.5|2.87|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.87|0.50|.681
71682056|NCT04027075|142882018|SUPERIORITY||Odds Ratio (OR)|1.18||||0.65|TWO_SIDED|95.0|0.58|2.42|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.42|0.58|.650
71864725|NCT05576662|143244519|OTHER||Odds Ratio (OR)|0.72||||0.6|TWO_SIDED|95.0|0.21|2.44||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|||2.44|0.21|.60
71864726|NCT05576662|143244520|OTHER||Odds Ratio (OR)|1.62||||0.156|TWO_SIDED|95.0|0.83|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 5||3.15|0.83|0.156
71682057|NCT04027075|142882019|SUPERIORITY||Odds Ratio (OR)|1.41||||0.304|TWO_SIDED|95.0|0.73|2.73|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||2.73|0.73|.304
71682058|NCT04027075|142882020|SUPERIORITY||Odds Ratio (OR)|1.44||||0.97|TWO_SIDED|95.0|0.69|3.0|||Chi-squared||The odds ratio applies to the group comparison (Intervention vs. Services as Usual) at 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||3.00|0.69|0.97
71910291|NCT05109702|143341657|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.067||0.016|TWO_SIDED|95.0|0.03|0.292|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.292|0.030|0.016
71910292|NCT05109702|143341657|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.067||0.099|TWO_SIDED|95.0|-0.021|0.242|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.242|-0.021|0.099
71910293|NCT05109702|143341657|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.068||0.493|TWO_SIDED|95.0|-0.086|0.179|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.179|-0.086|0.493
71910294|NCT05109702|143341657|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.068||0.987|TWO_SIDED|95.0|-0.133|0.135|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.135|-0.133|0.987
71910295|NCT05109702|143341658|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.072||0.655|TWO_SIDED|95.0|-0.109|0.173|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.173|-0.109|0.655
71864727|NCT05576662|143244520|OTHER||Odds Ratio (OR)|1.99||||0.03|TWO_SIDED|95.0|1.06|3.72||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 10||3.72|1.06|0.03
71864728|NCT05576662|143244520|OTHER||Odds Ratio (OR)|2.42||||0.01|TWO_SIDED|95.0|1.27|4.6||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, odds|Proportional odds regression coefficient Wald test|An odds ratio \< 1 favors nirmatrelvir plus ritonavir; an odds ratio \> 1 favors placebo plus ritonavir.|Analysis of severity at week 15||4.60|1.27|0.01
71864729|NCT05576662|143244521|OTHER||Hazard Ratio (HR)|0.9||||0.744|TWO_SIDED|95.0|0.45|1.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - fatigue"||1.77|0.45|0.744
71864730|NCT05576662|143244521|OTHER||Hazard Ratio (HR)|0.67||||0.259|TWO_SIDED|95.0|0.32|1.37||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - brain fog"||1.37|0.32|0.259
71864731|NCT05576662|143244521|OTHER||Hazard Ratio (HR)|1.61||||0.286|TWO_SIDED|95.0|0.65|3.99||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - body aches"||3.99|0.65|0.286
71864732|NCT05576662|143244521|OTHER||Hazard Ratio (HR)|0.92||||0.846|TWO_SIDED|95.0|0.38|2.24||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - cardiovascular symptoms"||2.24|0.38|0.846
71864733|NCT05576662|143244521|OTHER||Hazard Ratio (HR)|1.56||||0.41|TWO_SIDED|95.0|0.51|4.73||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test|A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.||"Analysis of data for Time to relief - shortness of breath"||4.73|0.51|0.410
71864734|NCT05576662|143244521|OTHER||Hazard Ratio (HR)|0.94||||0.88|TWO_SIDED|95.0|0.42|2.11||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|"Analysis of data for Time to relief - gastrointestinal symptoms"||2.11|0.42|0.880
71864735|NCT05576662|143244522|OTHER||Hazard Ratio (HR)|0.74||||0.33|TWO_SIDED|95.0|0.4|1.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Cox PH coefficient Wald test||A hazard ratio \< 1 favors nirmatrelvir plus ritonavir; a hazard ratio \> 1 favors placebo plus ritonavir.|||1.38|0.40|0.33
71682059|NCT04027075|142882021|SUPERIORITY||Mean Difference (Final Values)|-1.78|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.005
71682060|NCT04027075|142882022|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.09||0.46|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.460
71682061|NCT04027075|142882023|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.26||0.851|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.851
71682062|NCT04027075|142882024|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.23||0.977|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.977
71682063|NCT04027075|142882025|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.27||0.456|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.456
71910296|NCT05109702|143341658|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.072||0.826|TWO_SIDED|95.0|-0.157|0.125|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.125|-0.157|0.826
71910297|NCT05109702|143341658|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.073||0.861|TWO_SIDED|95.0|-0.155|0.13|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.130|-0.155|0.861
71910298|NCT05109702|143341658|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.073||0.556|TWO_SIDED|95.0|-0.101|0.187|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.187|-0.101|0.556
71910299|NCT05109702|143341659|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.087||0.527|TWO_SIDED|95.0|-0.116|0.226|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.226|-0.116|0.527
71910300|NCT05109702|143341659|SUPERIORITY||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.087||0.005|TWO_SIDED|95.0|0.077|0.418|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.418|0.077|0.005
71910301|NCT05109702|143341659|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.088||0.92|TWO_SIDED|95.0|-0.164|0.181|||MMRM|||Wek 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.181|-0.164|0.920
71922144|NCT03091920|143364999|OTHER|No statistical testing was performed.|Least squares mean difference|-3.32|STANDARD_ERROR_OF_MEAN|2.64|||TWO_SIDED|95.0|-8.79|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.14|-8.79|
71922145|NCT03091920|143364999|OTHER|No statistical testing was performed.|Least squares mean difference|-1.74|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|-7.14|3.67|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||3.67|-7.14|
71682064|NCT04027075|142882026|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.31||0.874|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.874
71682065|NCT04027075|142882027|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.24||0.069|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.069
71922146|NCT03091920|143364999|OTHER|No statistical testing was performed.|Least squares mean difference|-1.88|STANDARD_ERROR_OF_MEAN|3.22|||TWO_SIDED|95.0|-8.58|4.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||4.83|-8.58|
71922147|NCT03091920|143364999|OTHER|No statistical testing was performed.|Least squares mean difference|-4.3|STANDARD_ERROR_OF_MEAN|3.08|||TWO_SIDED|95.0|-10.69|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.10|-10.69|
71682066|NCT04027075|142882028|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.658|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.658
71864736|NCT05576662|143244523|OTHER||Mean Difference (Net)|0.57||||0.66|TWO_SIDED|95.0|-1.96|3.1||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.10|-1.96|.66
71864737|NCT05576662|143244524|OTHER||Mean Difference (Net)|0.38||||0.79|TWO_SIDED|95.0|-2.4|3.15||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.15|-2.40|0.79
71864738|NCT05576662|143244525|OTHER||Mean Difference (Net)|0.6||||0.7|TWO_SIDED|95.0|-2.55|3.75||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||3.75|-2.55|.70
71864739|NCT05576662|143244526|OTHER||Mean Difference (Net)|0.03||||0.98|TWO_SIDED|95.0|-3.21|3.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.28|-3.21|.98
71864740|NCT05576662|143244527|OTHER||Mean Difference (Net)|1.73||||0.555|TWO_SIDED|95.0|-4.06|7.53||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of systolic blood pressure||7.53|-4.06|0.555
71864741|NCT05576662|143244527|OTHER||Mean Difference (Net)|-0.68||||0.764|TWO_SIDED|95.0|-5.15|3.79||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of data for change of diastolic blood pressure||3.79|-5.15|0.764
71864742|NCT05576662|143244528|OTHER||Mean Difference (Net)|-0.51||||0.856|TWO_SIDED|95.0|-6.15|5.12||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|||5.12|-6.15|0.856
71682067|NCT04027075|142882029|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.783|TWO_SIDED||||||t-test, 2 sided||The mean difference applies to the group comparison (Intervention vs. Services as Usual) in trajectory differences from baseline through 3-months. Group was coded 1 = Intervention and 0 = Services as Usual.|||||.783
71682068|NCT00455520|142882060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.7|-0.92|||ANCOVA|||Analysis of Covariance Model with factors of treatment, country, prior opioid use, and baseline dose level and start of DB pain score as factors.||-0.92|-1.7|<0.001
71910302|NCT05109702|143341659|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.089||0.286|TWO_SIDED|95.0|-0.08|0.269|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.269|-0.080|0.286
71910303|NCT05109702|143341660|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.098||0.071|TWO_SIDED|95.0|-0.015|0.369|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.369|-0.015|0.071
71910304|NCT05109702|143341660|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.098||0.384|TWO_SIDED|95.0|-0.107|0.278|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.278|-0.107|0.384
71910305|NCT05109702|143341660|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.391|TWO_SIDED|95.0|-0.109|0.28|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.280|-0.109|0.391
71910306|NCT05109702|143341660|SUPERIORITY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.1||0.802|TWO_SIDED|95.0|-0.171|0.222|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.222|-0.171|0.802
71910307|NCT05109702|143341661|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.098||0.884|TWO_SIDED|95.0|-0.206|0.178|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.178|-0.206|0.884
71910308|NCT05109702|143341661|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.098||0.303|TWO_SIDED|95.0|-0.091|0.293|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.293|-0.091|0.303
71910309|NCT05109702|143341661|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.099||0.554|TWO_SIDED|95.0|-0.135|0.253|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.253|-0.135|0.554
71910310|NCT05109702|143341661|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.051|TWO_SIDED|95.0|-0.001|0.391|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.391|-0.001|0.051
71682069|NCT00628095|142882082|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0221||||0.591|TWO_SIDED|90.0|-0.17|0.13|||Normal Approximation method|No adjustments for multiple comparisons were performed.|Power of 80% and a Type I error at 0.10 in a 1-sided test was calculated. Null hypothesis stated that there was no difference between the CE-224,535 and placebo arm groups, on the percentage of ACR 20 responders at Week 12.|Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.13|-0.17|0.591
71682070|NCT00628095|142882083|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.1232||||0.941|TWO_SIDED|80.0|-0.22|-0.02|||Normal Approximation method|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||-0.02|-0.22|0.941
71682071|NCT00628095|142882083|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0622||||0.742|TWO_SIDED|80.0|-0.18|0.05|||Normal Approximation method|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.05|-0.18|0.742
71910311|NCT05109702|143341662|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.17||0.131|TWO_SIDED|95.0|-0.077|0.591|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.591|-0.077|0.131
71910312|NCT05109702|143341662|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.171||0.04|TWO_SIDED|95.0|0.016|0.685|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.685|0.016|0.040
71910313|NCT05109702|143341662|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.172||0.767|TWO_SIDED|95.0|-0.287|0.389|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.389|-0.287|0.767
71910314|NCT05109702|143341662|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.174||0.41|TWO_SIDED|95.0|-0.198|0.485|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.198|0.410
71910315|NCT05109702|143341663|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.17||0.324|TWO_SIDED|95.0|-0.166|0.501|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.501|-0.166|0.324
71910316|NCT05109702|143341663|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.17||0.262|TWO_SIDED|95.0|-0.143|0.525|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.525|-0.143|0.262
71910317|NCT05109702|143341663|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.172||0.391|TWO_SIDED|95.0|-0.19|0.485|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.485|-0.190|0.391
71910318|NCT05109702|143341663|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.174||0.192|TWO_SIDED|95.0|-0.114|0.568|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.568|-0.114|0.192
71910319|NCT05109702|143341664|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.29||0.14|TWO_SIDED|95.0|-0.141|0.999|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.999|-0.141|0.140
71910320|NCT05109702|143341664|SUPERIORITY||LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.291||0.061|TWO_SIDED|95.0|-0.025|1.117|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.117|-0.025|0.061
71910321|NCT05109702|143341664|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.294||0.49|TWO_SIDED|95.0|-0.374|0.78|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.780|-0.374|0.490
71910322|NCT05109702|143341664|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.297||0.212|TWO_SIDED|95.0|-0.212|0.953|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.953|-0.212|0.212
71682072|NCT00628095|142882083|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.004||||0.482|TWO_SIDED|80.0|-0.11|0.12|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.12|-0.11|0.482
71682073|NCT00628095|142882084|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0072||||0.989|TWO_SIDED|80.0|-0.08|0.06|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.06|-0.08|0.989
71682074|NCT00628095|142882084|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.0096||||0.957|TWO_SIDED|80.0|-0.08|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.08|0.957
71682075|NCT00628095|142882084|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0044||||0.473|TWO_SIDED|80.0|-0.08|0.09|||Normal Approximation method|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.09|-0.08|0.473
71682076|NCT00628095|142882084|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-0.057||||0.793|TWO_SIDED|80.0|-0.15|0.03|||Normal Approximation method|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the normal approximation method.||0.03|-0.15|0.793
71682077|NCT00628095|142882085|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 2: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
71910323|NCT05109702|143341665|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.784|TWO_SIDED|95.0|-0.134|0.101|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.101|-0.134|0.784
71910324|NCT05109702|143341665|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.06||0.324|TWO_SIDED|95.0|-0.058|0.176|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.176|-0.058|0.324
71910325|NCT05109702|143341665|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.06||0.13|TWO_SIDED|95.0|-0.027|0.21|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.210|-0.027|0.130
71910326|NCT05109702|143341665|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.061||0|TWO_SIDED|95.0|0.11|0.35|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.350|0.110|0.000
71910327|NCT05109702|143341666|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.623||0.532|TWO_SIDED|95.0|-0.834|1.613|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.613|-0.834|0.532
71922148|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-4.45|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-11.3|2.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.41|-11.30|
71682078|NCT00628095|142882085|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0141||||0.421|TWO_SIDED|80.0|-0.05|0.07|||Barnard exact test|||Week 4: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.07|-0.05|0.421
71682079|NCT00628095|142882085|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0566||||0.058|TWO_SIDED|80.0|0.01|0.12|||Barnard exact test|||Week 8: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.12|0.01|0.058
71922149|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-5.17|STANDARD_ERROR_OF_MEAN|3.34|||TWO_SIDED|95.0|-12.1|1.75|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.75|-12.10|
71922150|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-5.23|STANDARD_ERROR_OF_MEAN|3.69|||TWO_SIDED|95.0|-12.87|2.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||2.42|-12.87|
71682080|NCT00628095|142882085|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|0.0377||||0.121|TWO_SIDED|80.0|0.0|0.09|||Barnard exact test|||Week 12: Treatment effect was estimated by the difference of percentages between the treatment groups, and tested using the Barnard exact test.||0.09|-0.00|0.121
71682081|NCT00628095|142882093|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 2: p-value was analyzed using Barnard Exact Test.||||1.0000
71682082|NCT00628095|142882093|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 4: p-value was analyzed using Barnard Exact Test.||||1.0000
71682083|NCT00628095|142882093|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED||||||Barnard exact test|||Week 8: p-value was analyzed using Barnard Exact Test.||||1.0000
71682084|NCT00628095|142882093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 12: p-value was analyzed using Barnard Exact Test.||||0.0637
71682085|NCT00628095|142882093|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED||||||Barnard exact test|||Week 14: p-value was analyzed using Barnard Exact Test.||||0.0637
71910328|NCT05109702|143341666|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.63||0.252|TWO_SIDED|95.0|-0.515|1.959|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||1.959|-0.515|0.252
71910329|NCT05109702|143341666|SUPERIORITY||LS Mean Difference|1.98|STANDARD_ERROR_OF_MEAN|0.636||0.002|TWO_SIDED|95.0|0.732|3.231|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||3.231|0.732|0.002
71910330|NCT05109702|143341667|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.167||0.723|TWO_SIDED|95.0|-0.386|0.268|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.268|-0.386|0.723
71910331|NCT05109702|143341667|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.167||0.254|TWO_SIDED|95.0|-0.519|0.137|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.137|-0.519|0.254
71910332|NCT05109702|143341667|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.169||0.034|TWO_SIDED|95.0|-0.69|-0.028|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||-0.028|-0.690|0.034
71910333|NCT05109702|143341667|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.171||0.64|TWO_SIDED|95.0|-0.255|0.414|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.414|-0.255|0.640
71910334|NCT05109702|143341668|SUPERIORITY|Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.|LS Mean Difference|1.45|STANDARD_DEVIATION|2.893||0.615|TWO_SIDED|95.0|-4.223|7.133|||MMRM|||||7.133|-4.223|0.615
71910335|NCT05109702|143341668|SUPERIORITY||LS Mean Difference|4.81|STANDARD_DEVIATION|2.894||0.097|TWO_SIDED|95.0|-0.866|10.494|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.494|-0.866|0.097
71910336|NCT05109702|143341668|SUPERIORITY||LS Mean Difference|1.06|STANDARD_DEVIATION|2.93||0.718|TWO_SIDED|95.0|-4.69|6.81|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.810|-4.690|0.718
71910337|NCT05109702|143341668|SUPERIORITY||LS Mean Difference|3.09|STANDARD_ERROR_OF_MEAN|2.963||0.298|TWO_SIDED|95.0|-2.728|8.903|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.903|-2.728|0.298
71910338|NCT05109702|143341669|SUPERIORITY||LS Mean Difference|2.67|STANDARD_ERROR_OF_MEAN|2.814||0.343|TWO_SIDED|95.0|-2.854|8.191|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.191|-2.854|0.343
71682086|NCT00006305|142882106|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.005||||0.97|TWO_SIDED|95.0|-0.031|0.02||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Revascularization compared with Medical therapy|||0.020|-0.031|0.97
71682087|NCT00006305|142882106|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.003||||0.89|TWO_SIDED|95.0|-0.029|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.022|-0.029|0.89
71682088|NCT00006305|142882107|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.013||||0.7|TWO_SIDED|95.0|-0.049|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Revascularization compared with Medical Therapy|||0.022|-0.049|0.70
71682089|NCT00006305|142882107|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.024||||0.13||95.0|-0.06|0.012||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy|||0.012|-0.060|0.13
71682090|NCT01928797|142882108|SUPERIORITY|||||||0.37|||||||Chi-squared|||||||0.37
71682091|NCT01928797|142882109|SUPERIORITY|||||||0.33|||||||Chi-squared|||||||0.33
71682092|NCT00662558|142882111|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.|Risk Difference (RD)|0.091||||||95.0|0.0255|0.1565||||||||0.1565|0.0255|
71682093|NCT00662558|142882111|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|||If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.||||0.008
71682094|NCT00662558|142882112|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.17||0.234||95.0|-0.53|0.13|||ANCOVA||The mean difference reported is the least squares (LS) mean difference.|The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.||0.13|-0.53|0.234
71682095|NCT00662558|142882113|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.94|STANDARD_ERROR_OF_MEAN|1.76||0.595||95.0|-4.39|2.52|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.52|-4.39|0.595
71682096|NCT00662558|142882114|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.829
71682097|NCT00662558|142882115|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.470
71682098|NCT00662558|142882116|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.32||0.339||95.0|-0.95|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.95|0.339
71682099|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.741||95.0|-0.36|0.25|||ANCOVA||The mean difference reported is the LS mean difference.|How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.25|-0.36|0.741
71682100|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.17||0.796||95.0|-0.38|0.29|||ANCOVA||The mean difference reported is the LS mean difference.|Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.29|-0.38|0.796
71682101|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.16||0.492||95.0|-0.41|0.2|||ANCOVA||The mean difference reported is the LS mean difference.|Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.20|-0.41|0.492
71682102|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.893||95.0|-0.28|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.28|0.893
71682103|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.16||0.618||95.0|-0.4|0.24|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.24|-0.40|0.618
71682104|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.16||0.44||95.0|-0.19|0.43|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.43|-0.19|0.440
71682105|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.14||0.806||95.0|-0.25|0.32|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.32|-0.25|0.806
71682106|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.17||0.739||95.0|-0.38|0.27|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.27|-0.38|0.739
71682107|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.17||0.992||95.0|-0.32|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.33|-0.32|0.992
71864743|NCT05576662|143244529|OTHER||Mean Difference (Net)|-0.41||||0.833|TWO_SIDED|95.0|-4.24|3.42||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors placebo plus ritonavir; a mean difference \> 0 favors nirmatrelvir plus ritonavir.|||3.42|-4.24|0.833
71864744|NCT05576662|143244530|OTHER||Mean Difference (Final Values)|0.32||||0.096|TWO_SIDED|95.0|-0.06|0.7||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.70|-0.06|0.096
71910339|NCT05109702|143341669|SUPERIORITY||LS Mean Difference|3.71|STANDARD_ERROR_OF_MEAN|2.814||0.188|TWO_SIDED|95.0|-1.813|9.232|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.232|-1.813|0.188
71910340|NCT05109702|143341669|SUPERIORITY||LS Mean Difference|2.55|STANDARD_ERROR_OF_MEAN|2.849||0.371|TWO_SIDED|95.0|-3.04|8.143|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||8.143|-3.040|0.371
71910341|NCT05109702|143341669|SUPERIORITY||LS Mean Difference|6.92|STANDARD_ERROR_OF_MEAN|2.883||0.017|TWO_SIDED|95.0|1.259|12.573|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||12.573|1.259|0.017
71910342|NCT05109702|143341670|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|2.7||0.754|TWO_SIDED|95.0|-4.452|6.147|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.147|-4.452|0.754
71910343|NCT05109702|143341670|SUPERIORITY||LS Mean Difference|2.43|STANDARD_ERROR_OF_MEAN|2.7||0.368|TWO_SIDED|95.0|-2.865|7.731|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.731|-2.865|0.368
71910344|NCT05109702|143341670|SUPERIORITY||LS Mean Difference|1.35|STANDARD_ERROR_OF_MEAN|2.734||0.621|TWO_SIDED|95.0|-4.014|6.715|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||6.715|-4.014|0.621
71910345|NCT05109702|143341670|SUPERIORITY||LS Mean Difference|4.74|STANDARD_ERROR_OF_MEAN|2.766||0.087|TWO_SIDED|95.0|-0.688|10.168|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.168|-0.688|0.087
71864745|NCT05576662|143244530|OTHER||Mean Difference (Final Values)|0.22||||0.293|TWO_SIDED|95.0|-0.2|0.64||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.64|-0.20|0.293
71864746|NCT05576662|143244530|OTHER||Mean Difference (Final Values)|0.19||||0.396|TWO_SIDED|95.0|-0.25|0.62||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.62|-0.25|0.396
71864747|NCT05576662|143244530|OTHER||Mean Difference (Final Values)|0.37||||0.064|TWO_SIDED|95.0|-0.02|0.77||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.77|-0.02|0.064
71864748|NCT05576662|143244531|OTHER||Mean Difference (Final Values)|0.19||||0.444|TWO_SIDED|95.0|-0.3|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of day 15 data||0.67|-0.30|0.444
71922151|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-8.22|STANDARD_ERROR_OF_MEAN|3.58|||TWO_SIDED|95.0|-15.64|-0.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||-0.79|-15.64|
71864749|NCT05576662|143244531|OTHER||Mean Difference (Final Values)|-0.25||||0.346|TWO_SIDED|95.0|-0.78|0.28||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||0.28|-0.78|0.346
71864750|NCT05576662|143244531|OTHER||Mean Difference (Final Values)|0.1||||0.738|TWO_SIDED|95.0|-0.48|0.67||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.67|-0.48|0.738
71864751|NCT05576662|143244531|OTHER||Mean Difference (Final Values)|0.17||||0.578|TWO_SIDED|95.0|-0.43|0.76||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||0.76|-0.43|0.578
71864752|NCT05576662|143244532|OTHER||Mean Difference (Final Values)|-0.19||||0.758|TWO_SIDED|95.0|-1.41|1.03||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 5 data||1.03|-1.41|0.758
71864753|NCT05576662|143244532|OTHER||Mean Difference (Final Values)|-0.24||||0.693|TWO_SIDED|95.0|-1.46|0.97||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 10 data||0.97|-1.46|0.693
71864754|NCT05576662|143244532|OTHER||Mean Difference (Final Values)|0.37||||0.558|TWO_SIDED|95.0|-0.87|1.61||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Linear|Linear regression coefficient Wald test|A mean difference \< 0 favors nirmatrelvir plus ritonavir; a mean difference \> 0 favors placebo plus ritonavir.|Analysis of week 15 data||1.61|-0.87|0.558
71864755|NCT05576662|143244533|OTHER||Odds Ratio (OR)|0.55||||0.02|TWO_SIDED|95.0|0.33|0.92||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of fatigue data||0.92|0.33|0.02
71864756|NCT05576662|143244533|OTHER||Odds Ratio (OR)|0.5||||0.01|TWO_SIDED|95.0|0.31|0.82||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of brain fog data||0.82|0.31|0.01
71864757|NCT05576662|143244533|OTHER||Odds Ratio (OR)|1.32||||0.34|TWO_SIDED|95.0|0.74|2.33||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of body aches data||2.33|0.74|0.34
71864758|NCT05576662|143244533|OTHER||Odds Ratio (OR)|1.37||||0.29|TWO_SIDED|95.0|0.76|2.48||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of cardiovascular symptoms data||2.48|0.76|0.29
71864759|NCT05576662|143244533|OTHER||Odds Ratio (OR)|1.32||||0.35|TWO_SIDED|95.0|0.73|2.38||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of shortness of breath data||2.38|0.73|0.35
71864760|NCT05576662|143244533|OTHER||Odds Ratio (OR)|1.4||||0.25|TWO_SIDED|95.0|0.79|2.47||Uncorrected p-value. A p-value less than the a priori threshold of 0.05 is considered statistically significant.|Regression, Logistic|Logistic regression coefficient Wald test|An odds ratio \< 1 favors placebo plus ritonavir; an odds ratio \> 1 favors nirmatrelvir plus ritonavir.|Post-hoc analysis of gastrointestinal symptoms data||2.47|0.79|0.25
71864761|NCT03008005|143244534|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
71864762|NCT03008005|143244535|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||< 0.05
71864763|NCT01040169|143244563|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71864764|NCT01040169|143244564|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71910346|NCT05109702|143341671|SUPERIORITY||LS Mean Difference|4.23|STANDARD_ERROR_OF_MEAN|2.646||0.11|TWO_SIDED|95.0|-0.958|9.425|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.425|-0.958|0.110
71910347|NCT05109702|143341671|SUPERIORITY||LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|2.647||0.315|TWO_SIDED|95.0|-2.535|7.855|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.855|-2.535|0.315
71864765|NCT00558792|143244605|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||Chi-squared|||||||0.0099
71864766|NCT00558792|143244606|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71864767|NCT00558792|143244607|SUPERIORITY_OR_OTHER|||||||0.1212||95.0|||||Chi-squared|||||||0.1212
71864768|NCT00558792|143244609|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||||||0.0200
71864769|NCT00558792|143244610|SUPERIORITY_OR_OTHER|||||||0.0044||95.0|||||ANOVA|||||||0.0044
71864770|NCT00558792|143244611|SUPERIORITY_OR_OTHER|||||||0.0371||95.0|||||ANOVA|||||||0.0371
71864771|NCT00558792|143244612|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|14.1||||0.2758|TWO_SIDED|95.0|-11.4|39.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||39.6|-11.4|0.2758
71864772|NCT00558792|143244612|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|12.3||||0.3102|TWO_SIDED|95.0|-11.1|35.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.6|-11.1|0.3102
71864773|NCT00558792|143244612|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|1.9||||0.8893|TWO_SIDED|95.0|-24.6|28.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||28.4|-24.6|0.8893
71864774|NCT00558792|143244613|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.7||||0.2511|TWO_SIDED|95.0|-4.7|1.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.3|-4.7|0.2511
71864775|NCT00558792|143244613|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|1.3||||0.4985|TWO_SIDED|95.0|-2.6|5.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||5.3|-2.6|0.4985
71864776|NCT00558792|143244613|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.1||||0.0693|TWO_SIDED|95.0|-6.5|0.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.4|-6.5|0.0693
71864777|NCT00558792|143244614|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-1.5||||0.9104|TWO_SIDED|95.0|-27.9|24.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||24.8|-27.9|0.9104
71864778|NCT00558792|143244614|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|-12.6||||0.2857|TWO_SIDED|95.0|-35.7|10.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||10.5|-35.7|0.2857
71864779|NCT00558792|143244614|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|11.1||||0.3664|TWO_SIDED|95.0|-13.3|35.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||35.5|-13.3|0.3664
71864780|NCT00558792|143244615|SUPERIORITY_OR_OTHER||Difference in Specifcity between Doses|-3.7||||0.1322|TWO_SIDED|95.0|-8.7|1.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.2|-8.7|0.1322
71864781|NCT00558792|143244615|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-1.3||||0.6381|TWO_SIDED|95.0|-6.9|4.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.2|-6.9|0.6381
71864782|NCT00558792|143244615|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-2.4||||0.3217|TWO_SIDED|95.0|-7.2|2.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||2.4|-7.2|0.3217
71864783|NCT00558792|143244616|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|7.6||||0.5843|TWO_SIDED|95.0|-19.6|34.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||34.7|-19.6|0.5843
71864784|NCT00558792|143244616|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|4.6||||0.7197|TWO_SIDED|95.0|-20.5|29.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||29.7|-20.5|0.7197
71864785|NCT00558792|143244616|SUPERIORITY_OR_OTHER||Difference in Sensitivity between Doses|3.0||||0.8292|TWO_SIDED|95.0|-24.1|30.1||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||30.1|-24.1|0.8292
71864786|NCT00558792|143244617|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-4.2||||0.0888|TWO_SIDED|95.0|-9.0|0.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||0.7|-9.0|0.0888
71864787|NCT00558792|143244617|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-0.8||||0.7796|TWO_SIDED|95.0|-6.4|4.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||4.8|-6.4|0.7796
71864788|NCT00558792|143244617|SUPERIORITY_OR_OTHER||Difference in Specificity between Doses|-3.4||||0.1662|TWO_SIDED|95.0|-8.2|1.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared|||||1.5|-8.2|0.1662
71864789|NCT02284009|143244663|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|0.0|0.24|||||Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide - Placebo) \>= 0.2 nmol/L = 0.097.|||0.24|0.00|
71864790|NCT04092530|143244741|OTHER||Risk Ratio (RR)|0.82||||0.12|TWO_SIDED|95.0|0.64|1.05|||Mixed Models Analysis|Adjusted for time; clustering by clinical site accounted for with random intercept||Please note that there were only 7 units (community health clinics) analyzed at Level 2 of this multilevel study, but due to the crossover design of the study, they were each observed under both the Control and Intervention conditions. Therefore, the Units Analyzed entered above reflect the 7 clinics under both conditions and should not be summed to 14.||1.05|0.64|0.12
71864791|NCT04092530|143244742|OTHER||Risk Ratio (RR)|0.89||||0.33|TWO_SIDED|95.0|0.7|1.13|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||1.13|0.70|0.33
71864792|NCT04092530|143244743|OTHER||Risk Ratio (RR)|1.1||||0.88|TWO_SIDED|95.0|0.33|3.73|||Mixed Models Analysis|Adjusted for time; random intercept for clinical site||||3.73|0.33|0.88
71864793|NCT03301155|143244753|SUPERIORITY|||||||0.001|||||||Regression, Logistic|Comparison performed on the regression parameters scale. Estimates for mean time obtained under assumption of exponentially distributed time-to-event.||||||0.001
71864794|NCT03301155|143244753|SUPERIORITY|superiority margin for hazard ratio was prespecified as 0.846. Lower hazard is better thus the upper confidence limit of HR expected to be lesser than margin|Hazard Ratio (HR)|0.645||||0.0218|TWO_SIDED|95.0|0.496|0.839|||Regression, Cox||Lower HR is better|||0.839|0.496|0.0218
71864795|NCT03301155|143244754|SUPERIORITY|||||||0.0003||||||Adjusted with Holm method for multiple comparrisons|Fisher Exact|||Comparison between groups on week 4||||0.0003
71864796|NCT03301155|143244754|SUPERIORITY|Adjusted with Holm method for multiple comparrisons||||||0.0003|||||||Fisher Exact|||Comparison between groups on week 8||||0.0003
71864797|NCT03301155|143244754|SUPERIORITY|||||||0.0021|||||||Fisher Exact|||Comparison between groups on week 12||||0.0021
71864798|NCT03301155|143244755|SUPERIORITY|||||||0.1372|||||||Fisher Exact|||||||0.1372
71864799|NCT03301155|143244756|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71864800|NCT03301155|143244757|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71864801|NCT00384189|143244763|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|9.8|STANDARD_ERROR_OF_MEAN|4.3||0.0116|TWO_SIDED|95.0|1.4|18.3|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||18.3|1.4|0.0116
71864802|NCT00384189|143244763|SUPERIORITY_OR_OTHER||Least Square Means Difference|9.4|STANDARD_ERROR_OF_MEAN|4.3||0.0148|TWO_SIDED|95.0|0.9|17.8|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||17.8|0.9|0.0148
71864803|NCT00384189|143244763|SUPERIORITY_OR_OTHER||Least Squares Means Difference|12.0|STANDARD_ERROR_OF_MEAN|4.3||0.0028|TWO_SIDED|95.0|3.5|20.4|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.||||20.4|3.5|0.0028
71864804|NCT00384189|143244764|SUPERIORITY_OR_OTHER|||||||0.1362||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1362
71864805|NCT00384189|143244764|SUPERIORITY_OR_OTHER|||||||0.0891||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.0891
71864806|NCT00384189|143244764|SUPERIORITY_OR_OTHER|||||||0.1574||||||Two-sided p-value, significance level 5%.|Log Rank|||||||0.1574
71864807|NCT00384189|143244765|SUPERIORITY_OR_OTHER|||||||0.001||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0010
71864808|NCT00384189|143244765|SUPERIORITY_OR_OTHER|||||||0.0006||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0006
71864809|NCT00384189|143244765|SUPERIORITY_OR_OTHER|||||||0.0002||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)|||||||0.0002
71864810|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference :|-13.5|||||TWO_SIDED|95.0|-18.3|-8.7|||||2-Sided 95% CIs were calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1||-8.7|-18.3|
71864811|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-17.9|||||TWO_SIDED|95.0|-23.2|-12.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-12.4|-23.2|
71864812|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-11.0|||||TWO_SIDED|95.0|-16.0|-5.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||-5.9|-16.0|
71864813|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-12.6|||||TWO_SIDED|95.0|-17.8|-7.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||-7.2|-17.8|
71864814|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.1|||||TWO_SIDED|95.0|-19.5|-8.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||-8.6|-19.5|
71864815|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-15.8|||||TWO_SIDED|95.0|-21.0|-10.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||-10.6|-21.0|
71864816|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-2.6|||||TWO_SIDED|95.0|-6.3|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||1.1|-6.3|
71864817|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-14.3|||||TWO_SIDED|95.0|-19.7|-8.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||-8.9|-19.7|
71864818|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-3.3|||||TWO_SIDED|95.0|-7.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||1.4|-7.9|
71922152|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-6.72|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.29|0.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||0.86|-14.29|
71864819|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-5.5|||||TWO_SIDED|95.0|-10.6|-0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||-0.4|-10.6|
71864820|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.7|||||TWO_SIDED|95.0|-4.8|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.3|-4.8|
71864821|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-1.4|||||TWO_SIDED|95.0|-4.0|1.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.2|-4.0|
71864822|NCT04546425|143244795|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent Difference|-18.3|||||TWO_SIDED|95.0|-23.6|-12.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||-12.9|-23.6|
71864823|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|59.9|||||TWO_SIDED|95.0|55.6|64.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||64.1|55.6|
71864824|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-7.6|||||TWO_SIDED|95.0|-13.1|-2.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 10A||-2.1|-13.1|
71864825|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.6|||||TWO_SIDED|95.0|53.1|61.9|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 11A||61.9|53.1|
71864826|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|-6.2|||||TWO_SIDED|95.0|-11.7|-0.7|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 12F||-0.7|-11.7|
71864827|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 15B||62.1|53.3|
71864828|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|57.8|||||TWO_SIDED|95.0|53.3|62.1|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 22F||62.1|53.3|
71864829|NCT04546425|143244795|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC - lowest 13vPnC) was greater than -10%.|Percent difference|10.3|||||TWO_SIDED|95.0|4.5|16.0|||||2-Sided 95% CI based on the Percent difference for the difference in proportions expressed as a percentage.|Serotype 33F||16.0|4.5|
71864830|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.61|||||TWO_SIDED|95.0|0.54|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.69|0.54|
71864831|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.79|0.64|
71864832|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.69|0.52|
71922153|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-3.14|STANDARD_ERROR_OF_MEAN|3.63|||TWO_SIDED|95.0|-10.66|4.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||4.38|-10.66|
71682108|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.793||95.0|-0.28|0.36|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.36|-0.28|0.793
71910348|NCT05109702|143341671|SUPERIORITY||LS Mean Difference|2.67|STANDARD_DEVIATION|2.678||0.318|TWO_SIDED|95.0|-2.582|7.928|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.928|-2.582|0.318
71910349|NCT05109702|143341671|SUPERIORITY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.71||0.303|TWO_SIDED|95.0|-2.525|8.111|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.111|-2.525|0.303
71910350|NCT05109702|143341672|SUPERIORITY||LS Mean Difference|4.44|STANDARD_ERROR_OF_MEAN|2.975||0.136|TWO_SIDED|95.0|-1.402|10.273|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||10.273|-1.402|0.136
71910351|NCT05109702|143341672|SUPERIORITY||LS Mean Difference|4.13|STANDARD_ERROR_OF_MEAN|2.972||0.165|TWO_SIDED|95.0|-1.7|9.966|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||9.966|-1.700|0.165
71910352|NCT05109702|143341672|SUPERIORITY||LS Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|3.008||0.665|TWO_SIDED|95.0|-4.6|7.207|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||7.207|-4.600|0.665
71910353|NCT05109702|143341672|SUPERIORITY||LS Mean Difference|5.02|STANDARD_ERROR_OF_MEAN|3.043||0.099|TWO_SIDED|95.0|-0.95|10.995|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||10.995|-0.950|0.099
71910354|NCT05109702|143341673|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|2.926||0.861|TWO_SIDED|95.0|-5.232|6.254|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.254|-5.232|0.861
71910355|NCT05109702|143341673|SUPERIORITY||LS Mean Difference|1.76|STANDARD_ERROR_OF_MEAN|2.925||0.548|TWO_SIDED|95.0|-3.983|7.497|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.497|-3.983|0.548
71910356|NCT05109702|143341673|SUPERIORITY||LS Mean Difference|3.97|STANDARD_ERROR_OF_MEAN|2.96||0.18|TWO_SIDED|95.0|-1.839|9.777|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.777|-1.839|0.180
71910357|NCT05109702|143341673|SUPERIORITY||LS Mean Difference|3.93|STANDARD_ERROR_OF_MEAN|2.993||0.189|TWO_SIDED|95.0|-1.941|9.807|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.807|-1.941|0.189
71864833|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.7|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.70|0.52|
71864834|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.45|0.65|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.65|0.45|
71864835|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.51|||||TWO_SIDED|95.0|0.43|0.61|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.61|0.43|
71864836|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.64|
71864837|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.5|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.69|0.50|
71864838|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.7|0.96|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.96|0.70|
71864839|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.79|||||TWO_SIDED|95.0|0.67|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.92|0.67|
71864840|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.69|0.51|
71864841|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.82|0.64|
71864842|NCT04546425|143244796|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.52|||||TWO_SIDED|95.0|0.44|0.62|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.62|0.44|
71864843|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.55|||||TWO_SIDED|95.0|22.98|30.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||30.67|22.98|
71864844|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.67|||||TWO_SIDED|95.0|2.25|3.17|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||3.17|2.25|
71922154|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|0.37|STANDARD_ERROR_OF_MEAN|2.45|||TWO_SIDED|95.0|-4.71|5.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||5.45|-4.71|
71922155|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-0.02|STANDARD_ERROR_OF_MEAN|2.37|||TWO_SIDED|95.0|-4.94|4.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16||4.91|-4.94|
71922156|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-2.33|STANDARD_ERROR_OF_MEAN|3.73|||TWO_SIDED|95.0|-10.07|5.41|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.41|-10.07|
71864845|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|22.95|30.82|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||30.82|22.95|
71864846|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.48|||||TWO_SIDED|95.0|2.08|2.97|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||2.97|2.08|
71864847|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|54.6|||||TWO_SIDED|95.0|46.35|64.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||64.30|46.35|
71864848|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|36.8|||||TWO_SIDED|95.0|31.57|42.89|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||42.89|31.57|
71864849|NCT04546425|143244796|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.03|||||TWO_SIDED|95.0|4.27|5.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||5.92|4.27|
71864850|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.67|||||TWO_SIDED|95.0|0.6|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 1||0.75|0.60|
71864851|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.59|0.73|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 3||0.73|0.59|
71864852|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 4||0.87|0.68|
71864853|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||TWO_SIDED|95.0|0.64|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 5||0.81|0.64|
71864854|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.66|||||TWO_SIDED|95.0|0.57|0.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6A||0.75|0.57|
71864855|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.57|||||TWO_SIDED|95.0|0.48|0.67|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 6B||0.67|0.48|
71910358|NCT05109702|143341674|SUPERIORITY||LS Mean Difference|1.32|STANDARD_ERROR_OF_MEAN|2.608||0.613|TWO_SIDED|95.0|-3.799|6.438|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.438|-3.799|0.613
71910359|NCT05109702|143341674|SUPERIORITY||LS Mean Difference|4.53|STANDARD_ERROR_OF_MEAN|2.609||0.083|TWO_SIDED|95.0|-0.586|9.653|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.653|-0.586|0.083
71922157|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-2.45|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-10.26|5.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.37|-10.26|
71682109|NCT00662558|142882117|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.973||95.0|-0.27|0.28|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.28|-0.27|0.973
71682110|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|1.51||0.392||95.0|-4.26|1.67|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.67|-4.26|0.392
71682111|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|1.67||0.691||95.0|-3.94|2.61|||ANCOVA||The mean difference reported is the LS mean difference.|Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||2.61|-3.94|0.691
71864856|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.67|0.8|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 7F||0.80|0.67|
71864857|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.73|||||TWO_SIDED|95.0|0.66|0.81|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 9V||0.81|0.66|
71864858|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.92|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 14||0.92|0.69|
71864859|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.75|||||TWO_SIDED|95.0|0.67|0.84|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 18C||0.84|0.67|
71864860|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.82|||||TWO_SIDED|95.0|0.72|0.93|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19A||0.93|0.72|
71864861|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 19F||0.87|0.68|
71864862|NCT04546425|143244797|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC to the corresponding serotype in 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.6|||||TWO_SIDED|95.0|0.52|0.69|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 23F||0.69|0.52|
71864863|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.48|||||TWO_SIDED|95.0|1.32|1.66|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 8||1.66|1.32|
71864864|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.02|||||TWO_SIDED|95.0|1.77|2.3|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 10A||2.30|1.77|
71864865|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.55|||||TWO_SIDED|95.0|1.37|1.75|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 11A||1.75|1.37|
71682112|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|1.45||0.549||95.0|-3.7|1.97|||ANCOVA||The mean difference reported is the LS mean difference.|Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.97|-3.70|0.549
71682113|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.336||95.0|-0.67|0.23|||ANCOVA||The mean difference reported is the LS mean difference.|Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||0.23|-0.67|0.336
71682114|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.51|STANDARD_ERROR_OF_MEAN|1.69||0.37||95.0|-4.83|1.8|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.80|-4.83|0.370
71682115|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|1.34||0.341||95.0|-3.9|1.35|||ANCOVA||The mean difference reported is the LS mean difference.|Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.35|-3.90|0.341
71682116|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.604||95.0|-2.85|1.66|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.66|-2.85|0.604
71682117|NCT00662558|142882118|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|1.14||0.547||95.0|-2.92|1.55|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.55|-2.92|0.547
71682118|NCT00662558|142882119|SUPERIORITY_OR_OTHER_LEGACY|||||||0.196||95.0|||||Cochran-Mantel-Haenszel|||Optimal sleep was analyzed using CMH general association test.||||0.196
71864866|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 12F||0.87|0.68|
71864867|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|5.42|||||TWO_SIDED|95.0|4.82|6.1|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 15B||6.10|4.82|
71864868|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|3.84|||||TWO_SIDED|95.0|3.4|4.34|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 22F||4.34|3.40|
71682119|NCT00662558|142882120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.19|STANDARD_ERROR_OF_MEAN|1.91||0.252||95.0|-1.56|5.94|||ANCOVA||The mean difference reported is the LS mean difference.|Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||5.94|-1.56|0.252
71682120|NCT00662558|142882120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|1.88||0.798||95.0|-3.21|4.17|||ANCOVA||The mean difference reported is the LS mean difference.|Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.17|-3.21|0.798
71682121|NCT00662558|142882120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74|STANDARD_ERROR_OF_MEAN|1.92||0.7||95.0|-3.03|4.51|||ANCOVA||The mean difference reported is the LS mean difference.|Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||4.51|-3.03|0.700
71682122|NCT00662558|142882120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|1.72||0.902||95.0|-3.16|3.59|||ANCOVA||The mean difference reported is the LS mean difference.|Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||3.59|-3.16|0.902
71910360|NCT05109702|143341674|SUPERIORITY||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|2.639||0.165|TWO_SIDED|95.0|-1.508|8.851|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.851|-1.508|0.165
71910361|NCT05109702|143341674|SUPERIORITY||LS Mean Difference|4.28|STANDARD_ERROR_OF_MEAN|2.672||0.11|TWO_SIDED|95.0|-0.964|9.522|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||9.522|-0.964|0.110
71910362|NCT05109702|143341675|SUPERIORITY||LS Mean Difference|3.57|STANDARD_ERROR_OF_MEAN|1.743||0.041|TWO_SIDED|95.0|0.154|6.994|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.994|0.154|0.041
71910363|NCT05109702|143341675|SUPERIORITY||LS Mean Difference|2.7|STANDARD_ERROR_OF_MEAN|1.743||0.122|TWO_SIDED|95.0|-0.723|6.118|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||6.118|-0.723|0.122
71910364|NCT05109702|143341675|SUPERIORITY||LS Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.76||0.009|TWO_SIDED|95.0|1.146|8.056|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||8.056|1.146|0.009
71910365|NCT05109702|143341675|SUPERIORITY||LS Mean Difference|4.04|STANDARD_ERROR_OF_MEAN|1.781||0.024|TWO_SIDED|95.0|0.544|7.536|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||7.536|0.544|0.024
71910366|NCT05109702|143341676|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.282|TWO_SIDED|95.0|-0.115|0.394|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.115|0.282
71910367|NCT05109702|143341676|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.353|TWO_SIDED|95.0|-0.134|0.375|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.375|-0.134|0.353
71910368|NCT05109702|143341676|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.131||0.764|TWO_SIDED|95.0|-0.297|0.218|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.218|-0.297|0.764
71910369|NCT05109702|143341676|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.133||0.104|TWO_SIDED|95.0|-0.044|0.476|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.476|-0.044|0.104
71864869|NCT04546425|143244797|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 5 (13vPnC serotype with the lowest GMC, not including serotype 3) in the 13vPnC group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/lowest 13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|2.64|||||TWO_SIDED|95.0|2.33|2.99|||||2-sided 95% CI was calculated by exponentiating the CI (based on the Student's t distribution) for the mean difference of the logarithm of the concentrations.|Serotype 33F||2.99|2.33|
71864870|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|-0.2|||||TWO_SIDED|95.0|-1.3|0.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Diphtheria||0.8|-1.3|
71910370|NCT05109702|143341677|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.15||0.969|TWO_SIDED|95.0|-0.3|0.288|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.288|-0.300|0.969
71910371|NCT05109702|143341677|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.504|TWO_SIDED|95.0|-0.194|0.394|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.394|-0.194|0.504
71910372|NCT05109702|143341677|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.152||0.915|TWO_SIDED|95.0|-0.281|0.314|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.314|-0.281|0.915
71910373|NCT05109702|143341677|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.153||0.195|TWO_SIDED|95.0|-0.102|0.499|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.499|-0.102|0.195
71910374|NCT05109702|143341678|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.148||0.287|TWO_SIDED|95.0|-0.133|0.449|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.449|-0.133|0.287
71910375|NCT05109702|143341678|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.148||0.26|TWO_SIDED|95.0|-0.124|0.458|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.458|-0.124|0.260
71910376|NCT05109702|143341678|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.15||0.987|TWO_SIDED|95.0|-0.296|0.291|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.291|-0.296|0.987
71910377|NCT05109702|143341678|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.151||0.143|TWO_SIDED|95.0|-0.075|0.519|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.519|-0.075|0.143
71910378|NCT05109702|143341679|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.151||-0.198|TWO_SIDED|95.0|-0.102|0.49|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.490|-0.102|-0.198
71910379|NCT05109702|143341679|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.151||0.076|TWO_SIDED|95.0|-0.028|0.564|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.564|-0.028|0.076
71910380|NCT05109702|143341679|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.152||0.656|TWO_SIDED|95.0|-0.231|0.367|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.367|-0.231|0.656
71922158|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|95.0|-6.62|5.13|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.13|-6.62|
71682123|NCT00662558|142882120|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.46||0.581||95.0|-0.65|1.16|||ANCOVA||The mean difference reported is the LS mean difference.|Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.||1.16|-0.65|0.581
71682124|NCT00662558|142882121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 1.||||0.614
71682125|NCT00662558|142882121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 3.||||0.786
71910381|NCT05109702|143341679|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.154||0.324|TWO_SIDED|95.0|-0.15|0.454|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors.||0.454|-0.150|0.324
71910382|NCT05109702|143341680|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.146||0.477|TWO_SIDED|95.0|-0.182|0.39|||MMRM|||Week 1 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.390|-0.182|0.477
71910383|NCT05109702|143341680|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.146||0.033|TWO_SIDED|95.0|0.026|0.598|||MMRM|||Week 2 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.598|0.026|0.033
71910384|NCT05109702|143341680|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.147||0.374|TWO_SIDED|95.0|-0.158|0.42|||MMRM|||Week 4 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.420|-0.158|0.374
71910385|NCT05109702|143341680|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.149||0.114|TWO_SIDED|95.0|-0.056|0.529|||MMRM|||Week 8 : The LS means, LS mean difference, SEs, two-sided 95% CIs, and pvalues of the LS mean difference will be reported from the MMRM model. MMRM p-value calculated using the final model defined for the primary analysis endpoints, including terms for baseline, grouped sites, visit (as categorical term), treatment group and the interaction of treatment group and visit as fixed effects with correlated errors||0.529|-0.056|0.114
71910386|NCT05109702|143341681|SUPERIORITY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.329||0.598|TWO_SIDED|95.0|-0.822|0.475|||t-test, 2 sided|||Immediately Upon Instillation at Week 1||0.475|-0.822|0.598
71910387|NCT05109702|143341681|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.268||0.343|TWO_SIDED|95.0|-0.783|0.273|||t-test, 2 sided|||1 Minute Post Instillation at Week 1||0.273|-0.783|0.343
71910388|NCT05109702|143341681|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.359|TWO_SIDED|95.0|-0.721|0.262|||t-test, 2 sided|||2 Minutes Post Instillation at Week 1||0.262|-0.721|0.359
71910389|NCT03812588|143341682|SUPERIORITY||Slope|7.9|STANDARD_ERROR_OF_MEAN|7.261||0.292|TWO_SIDED|||||Linear regression model of condition in predicting change in HRSD-24. P-value and coefficient are Medication:Track. Medication (Escitalopram or Placebo) with Track (RFM or CFM) as co-variates. The threshold for statistical significance was p\>0.05.|Regression, Linear|||||||0.292
71910390|NCT00180271|143341685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.66|||<|0.001|TWO_SIDED|95.0|0.52|0.84||The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.|Log Rank||A Hazard ratio \< 1.0 would indicate that the result favors CRT-D.|The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.||0.84|0.52|< 0.001
71910391|NCT00180271|143341686|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.001|TWO_SIDED|95.0|0.53|0.86|||Andersen-Gill|Andersen-Gill model performed, adjusted for a previous HF event in the study, stratified by ischemic status and using robust variance estimation.|Model adjusted for previously experienced heart failure event in the study. Hazard Ratio (95% CI) comparing patients with a previous heart failure event to those patients without a prior heart failure event equaled 8.84 (6084, 11.43), p\<0.001.|||0.86|0.53|0.001
71910392|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0856|TWO_SIDED|95.0|0.69|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.69|0.0856
71910393|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.8546|TWO_SIDED|95.0|0.84|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.84|0.8546
71910394|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.73||||0.0012|TWO_SIDED|95.0|0.62|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.62|0.0012
71910395|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.8414|TWO_SIDED|95.0|0.87|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.87|0.8414
71910396|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2412|TWO_SIDED|95.0|0.64|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.64|0.2412
71682126|NCT00662558|142882121|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 6/ET.||||0.044
71682127|NCT00662558|142882122|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.870
71910397|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.4548|TWO_SIDED|95.0|0.88|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.88|0.4548
71910398|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.69||||0.0093|TWO_SIDED|95.0|0.53|0.88||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.88|0.53|0.0093
71910399|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.8414|TWO_SIDED|95.0|0.86|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.86|0.8414
71910400|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.1749|TWO_SIDED|95.0|0.75|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.75|0.1749
71910401|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.3121|TWO_SIDED|95.0|0.96|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.96|0.3121
71910402|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.1351|TWO_SIDED|95.0|0.78|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.78|0.1351
71910403|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.8414|TWO_SIDED|95.0|0.93|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.93|0.8414
71910404|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.83||||0.2158|TWO_SIDED|95.0|0.67|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.67|0.2158
71910405|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.3279|TWO_SIDED|95.0|0.71|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.71|0.3279
71910406|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2472|TWO_SIDED|95.0|0.72|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.72|0.2472
71910407|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.8414|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.8414
71910408|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6193|TWO_SIDED|95.0|0.81|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.81|0.6193
71910409|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
71910410|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0191|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0191
71910411|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.8414|TWO_SIDED|95.0|0.97|1.33||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.33|0.97|0.8414
71910412|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.76|0.2412
71864871|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-0.6|||||TWO_SIDED|95.0|-1.8|0.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Tetanus||0.2|-1.8|
71910413|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.99|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.99|0.3121
71910414|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.8||||0.0135|TWO_SIDED|95.0|0.68|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.68|0.0135
71910415|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.87|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.87|0.8414
71910416|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.1749|TWO_SIDED|95.0|0.66|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.66|0.1749
71910417|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.15||||0.3121|TWO_SIDED|95.0|0.93|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|0.93|0.3121
71910418|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.7||||0.0038|TWO_SIDED|95.0|0.57|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.57|0.0038
71910419|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.8414|TWO_SIDED|95.0|0.84|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.27|0.84|0.8414
71910420|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
71910421|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.2||||0.2053|TWO_SIDED|95.0|1.02|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.41|1.02|0.2053
71910422|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.0241|TWO_SIDED|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.70|0.0241
71910423|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.8414
71910424|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.0732|TWO_SIDED|95.0|0.69|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.94|0.69|0.0732
71910425|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.609|TWO_SIDED|95.0|0.82|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.82|0.6090
71682128|NCT00662558|142882123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.545||95.0|||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.||||0.545
71864872|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|-2.3|||||TWO_SIDED|95.0|-5.3|0.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PT||0.7|-5.3|
71864873|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.2|||||TWO_SIDED|95.0|-2.6|2.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|FHA||2.9|-2.6|
71910426|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.65|||<|0.0001|TWO_SIDED|95.0|0.56|0.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.76|0.56|<0.0001
71910427|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.8414|TWO_SIDED|95.0|0.82|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.82|0.8414
71910428|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7828|TWO_SIDED|95.0|0.82|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.82|0.7828
71910429|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.21||||0.2053|TWO_SIDED|95.0|1.02|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|1.02|0.2053
71910430|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0093|TWO_SIDED|95.0|0.65|0.92||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.92|0.65|0.0093
71910431|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.93|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.93|0.8414
71910432|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2412|TWO_SIDED|95.0|0.73|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.73|0.2412
71910433|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.14||||0.3121|TWO_SIDED|95.0|0.95|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.95|0.3121
71910434|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.77||||0.0135|TWO_SIDED|95.0|0.64|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.64|0.0135
71910435|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.8414|TWO_SIDED|95.0|0.92|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.92|0.8414
71910436|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.79|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.79|0.2412
71910437|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.6652|TWO_SIDED|95.0|0.91|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.91|0.6652
71910438|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.0275|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.0275
71910439|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.8414|TWO_SIDED|95.0|0.93|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.93|0.8414
71910440|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.2412|TWO_SIDED|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.76|0.2412
71682129|NCT00662558|142882124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.218||95.0|||||Cochran-Mantel-Haenszel|||CMH test adjusted for center was used to compare the two treatment groups.||||0.218
71682130|NCT00783224|142882129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71682131|NCT00783224|142882129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||ANCOVA|||||||0.0001
71864874|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.6|||||TWO_SIDED|95.0|-0.9|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|PRN||4.2|-0.9|
71682132|NCT01711619|142882130|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 4% was predefined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation of the proportion for ITT.||||<0.0001
71682133|NCT01711619|142882131|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Regression, Linear|||||||<0.0001
71682134|NCT01711619|142882132|SUPERIORITY_OR_OTHER|||||||0.0002||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||0.0002
71682135|NCT01711619|142882133|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.||||<0.0001
71682136|NCT00475878|142882149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64|STANDARD_ERROR_OF_MEAN|0.22||0.19|TWO_SIDED|95.0|0.33|1.24|||Chi-squared|||||1.24|.33|.19
71682137|NCT00475878|142882150|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.16||0.18|TWO_SIDED|95.0|-2.79|5.84|||t-test, 2 sided|||||5.84|-2.79|.18
71682138|NCT02584959|142882169|OTHER||Difference in LS means|-2.32|||<|0.0001|TWO_SIDED|95.0|-2.895|-1.744|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.744|-2.895|<0.0001
71682139|NCT02584959|142882171|OTHER||Difference in LS means|-2.323|||<|0.0001|TWO_SIDED|95.0|-2.969|-1.677|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-1.677|-2.969|<0.0001
71922159|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|95.0|-6.83|4.58|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.58|-6.83|
71922160|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-5.13|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-10.72|0.47|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||0.47|-10.72|
71922161|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-3.64|STANDARD_ERROR_OF_MEAN|2.72|||TWO_SIDED|95.0|-9.29|2.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||2.01|-9.29|
71922162|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-3.92|STANDARD_ERROR_OF_MEAN|3.52|||TWO_SIDED|95.0|-11.22|3.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.38|-11.22|
71922163|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-2.46|STANDARD_ERROR_OF_MEAN|3.42|||TWO_SIDED|95.0|-9.54|4.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||4.63|-9.54|
71922164|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-4.75|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-10.9|1.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||1.39|-10.90|
71922165|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-1.25|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.35|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||4.85|-7.35|
71922166|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-2.11|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-8.57|4.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.35|-8.57|
71922167|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|0.05|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-6.21|6.31|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||6.31|-6.21|
71922168|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-6.66|STANDARD_ERROR_OF_MEAN|3.65|||TWO_SIDED|95.0|-14.22|0.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.90|-14.22|
71922169|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-6.38|STANDARD_ERROR_OF_MEAN|3.68|||TWO_SIDED|95.0|-14.01|1.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||1.25|-14.01|
71922170|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-2.29|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-9.3|4.71|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.71|-9.30|
71922171|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-0.17|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-6.97|6.64|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.64|-6.97|
71682140|NCT02584959|142882174|OTHER||Difference in LS means|-4.881|||<|0.0001|TWO_SIDED|95.0|-6.113|-3.649|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.||-3.649|-6.113|<0.0001
71682141|NCT02584959|142882175|OTHER||Difference in LS means|5.435|||<|0.0001|TWO_SIDED|95.0|3.981|6.889|||Mixed Models Analysis|||||6.889|3.981|<0.0001
71682142|NCT02584959|142882176|OTHER||Difference in LS means|-2.175|||<|0.0001|TWO_SIDED|95.0|-2.75|-1.599|||Mixed Models Analysis|||||-1.599|-2.750|<0.0001
71682143|NCT02584959|142882191|OTHER||Difference in LS means|-31.735||||0.0001|TWO_SIDED|95.0|-42.696|-20.773|||Mixed Models Analysis|||The Least Square means, 95% confidence intervals and p-values are based on mixed effect linear model with period, sequence, use of prophylactic therapy with C1 INH at randomization and treatment as fixed effects and subject nested within sequence as a random effect.||-20.773|-42.696|0.0001
71910441|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.3121|TWO_SIDED|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.96|0.3121
71910442|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.0387|TWO_SIDED|95.0|0.72|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.72|0.0387
71910443|NCT01392378|143341687|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.8414|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.8414
71910444|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.82|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.82|0.9350
71910445|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.7918|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.7918
71910446|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.6922|TWO_SIDED|95.0|0.8|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.80|0.6922
71910447|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.11||||0.9765|TWO_SIDED|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.93|0.9765
71910448|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6915|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6915
71682144|NCT00195494|142882203|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.0|||<|0.001|||||||Fisher Exact||E+M (49.8%) - M (27.8%) creates the risk difference estimated value.|||||<0.001
71910449|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.94|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.94|0.7918
71910450|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.4389|TWO_SIDED|95.0|0.75|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.75|0.4389
71910451|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.85|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.85|0.9765
71910452|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.935|TWO_SIDED|95.0|0.87|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.87|0.9350
71910453|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.7918|TWO_SIDED|95.0|0.9|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.90|0.7918
71910454|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.943|TWO_SIDED|95.0|0.88|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.88|0.9430
71910455|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.9765|TWO_SIDED|95.0|0.85|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.85|0.9765
71910456|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.5167|TWO_SIDED|95.0|0.74|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.74|0.5167
71864875|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|1.1|||||TWO_SIDED|95.0|-1.1|4.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hepatitis B||4.0|-1.1|
71864876|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC -13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 1||4.2|-4.6|
71864877|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 2||4.2|-4.6|
71864878|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-4.6|4.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Poliovirus Type 3||4.2|-4.6|
71864879|NCT04546425|143244798|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC-13vPnC) was greater than -10%.|Percent difference|0.0|||||TWO_SIDED|95.0|-2.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnc - 13vPnC) expressed as a percentage.|Hib||2.2|-2.0|
71864880|NCT04546425|143244799|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.79|1.42|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Measles||1.42|0.79|
71864881|NCT04546425|143244800|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.04|||||TWO_SIDED|95.0|0.76|1.44|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Mumps||1.44|0.76|
71864882|NCT04546425|143244801|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.83|||||TWO_SIDED|95.0|0.63|1.1|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Rubella||1.10|0.63|
71864883|NCT04546425|143244802|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|1.24|||||TWO_SIDED|95.0|0.98|1.57|||||GMR and 2-sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the concentrations (20vPnC - 13vPnC) and the corresponding CIs (based on the Student's t distribution).|Varicella||1.57|0.98|
71864884|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.0|||||TWO_SIDED|95.0|-3.1|0.9|||||2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.|Serotype 1 \\||0.9|-3.1|
71864885|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-10.6|||||TWO_SIDED|95.0|-14.7|-6.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 3||-6.7|-14.7|
71864886|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 4||1.3|-1.4|
71864887|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.4|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 5||2.2|-1.4|
71864888|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.6|1.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6A||1.5|-1.6|
71864889|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.8|||||TWO_SIDED|95.0|-1.1|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 6B||2.7|-1.1|
71864890|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.4|||||TWO_SIDED|95.0|-1.5|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 7F||0.4|-1.5|
71864891|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.4|||||TWO_SIDED|95.0|-1.0|1.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 9V||1.9|-1.0|
71864892|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-1.5|||||TWO_SIDED|95.0|-3.7|0.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 14||0.6|-3.7|
71910457|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.7918|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.7918
71910458|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.2514|TWO_SIDED|95.0|0.73|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.73|0.2514
71910459|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.84|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.84|0.9872
71910460|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2582|TWO_SIDED|95.0|0.73|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.73|0.2582
71910461|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.91|0.7918
71910462|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.2514
71910463|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
71682145|NCT00195494|142882204|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.0|||<|0.001|||||||Fisher Exact||E+M (79.7%) - M (58.7%) creates the risk difference estimated value.|||||<0.001
71910464|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.6915|TWO_SIDED|95.0|0.86|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.86|0.6915
71910465|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.13||||0.7918|TWO_SIDED|95.0|0.93|1.38||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.38|0.93|0.7918
71910466|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.78|0.6922
71910467|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.9872|TWO_SIDED|95.0|0.83|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.83|0.9872
71910468|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.3609|TWO_SIDED|95.0|0.7|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.70|0.3609
71910469|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.7918|TWO_SIDED|95.0|0.89|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.89|0.7918
71910470|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.2514|TWO_SIDED|95.0|0.71|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.71|0.2514
71910471|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.9765|TWO_SIDED|95.0|0.86|1.26||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.26|0.86|0.9765
71910472|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.79|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.79|0.6304
71910473|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.7918|TWO_SIDED|95.0|0.91|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.91|0.7918
71910474|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.2514|TWO_SIDED|95.0|0.75|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.75|0.2514
71910475|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.9765|TWO_SIDED|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.88|0.9765
71910476|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.2582|TWO_SIDED|95.0|0.71|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.71|0.2582
71910477|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.9279|TWO_SIDED|95.0|0.84|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.18|0.84|0.9279
71910478|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.72|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.72|0.2514
71910479|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.9765|TWO_SIDED|95.0|0.76|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.76|0.9765
71910480|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.1424|TWO_SIDED|95.0|0.71|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.71|0.1424
71910481|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.7918|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.7918
71910482|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.2514|TWO_SIDED|95.0|0.73|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.73|0.2514
71910483|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.9765|TWO_SIDED|95.0|0.79|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.79|0.9765
71910484|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.6304|TWO_SIDED|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.78|0.6304
71682146|NCT01217385|142882215|EQUIVALENCE|under the NULL, it is assume that there is no difference between a 40% decrease in TOI, and a less than 40% decrease or an increase in TOI in their ability to predict pCR+|Odds Ratio (OR)|4.667||||0.059|TWO_SIDED|95.0|0.95|23.04||5% alpha threshold for significance.|Regression, Logistic|||"This analysis will look at the ability of the % change in DOSI measured tumor Optical Index (TOI) from baseline to mid-therapy to predict pathologic response using logistic regression.~Pathologic response (dichotomized into responders and non-responders) will be used as the reference standard and %change in TOI ratio (dichotomized at -40%) will be used to estimate pCR (+/-)= alpha + beta1(%change TOI)"||23.04|0.95|0.059
71910485|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
71910486|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.6922
71910487|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.9765|TWO_SIDED|95.0|0.82|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.82|0.9765
71910488|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6572|TWO_SIDED|95.0|0.84|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.84|0.6572
71910489|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.7918|TWO_SIDED|95.0|0.86|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.86|0.7918
71910490|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.2514|TWO_SIDED|95.0|0.79|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.79|0.2514
71910491|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.9872|TWO_SIDED|95.0|0.88|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.88|0.9872
71910492|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.6304|TWO_SIDED|95.0|0.78|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.78|0.6304
71910493|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.7918|TWO_SIDED|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.88|0.7918
71910494|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.6922|TWO_SIDED|95.0|0.8|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.80|0.6922
71910495|NCT01392378|143341689|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.9765|TWO_SIDED|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.81|0.9765
71864893|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|1.0|||||TWO_SIDED|95.0|-0.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 18C||2.7|-0.5|
71682147|NCT01217385|142882216|EQUIVALENCE|test for the equivalence of %change in TOI ratio (dichotomized at \<=-40%), between PR+ and PR- groups, with interaction|Slope|0.4463|STANDARD_ERROR_OF_MEAN|1.953||0.8193|TWO_SIDED|||||significance at alpha=0.05|Regression, Logistic|p-value represents the interaction between %TOI (dichotomized at \<=-40%), and PR status|Multivariate logistic regression model using % change in TOI ratio (T/N) (baseline to mid-therapy) dichotomized at -40%, PR status, and the corresponding interaction.|The Null is that the odd ratio is the same in both the PR+ and PR- subjects fro the model including %change in TOI form baseline to mid-therapy (dichotomized at \<=-40%), PR status (+/-) and the interaction between them.||||0.8193
71682148|NCT01217385|142882217|OTHER||Odds Ratio (OR)|16.5||||0.043|TWO_SIDED|95.0|1.09|250.15|||Regression, Logistic|||||250.15|1.09|0.043
71682149|NCT01217385|142882217|OTHER||Odds Ratio (OR)|2.86||||0.406|TWO_SIDED|95.0|0.24|33.9|||Regression, Logistic|||||33.90|0.24|0.406
71682150|NCT02431806|142882247|SUPERIORITY||Least Squares (LS) Mean Difference|-0.38||||0.8035|TWO_SIDED|95.0|-3.41|2.64|||Mixed Model Repeated Measures (MMRM)||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||2.64|-3.41|0.8035
71682151|NCT02431806|142882247|SUPERIORITY||LS Mean Difference|0.26||||0.8681|TWO_SIDED|95.0|-2.8|3.31|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||3.31|-2.80|0.8681
71682152|NCT02431806|142882247|SUPERIORITY||LS Mean|-1.47||||0.3439|TWO_SIDED|95.0|-4.52|1.58|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||1.58|-4.52|0.3439
71682153|NCT02431806|142882248|SUPERIORITY||LS Mean Difference|0.02||||0.8788|TWO_SIDED|95.0|-0.25|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.25|0.8788
71682154|NCT02431806|142882248|SUPERIORITY||LS Mean Difference|0.01||||0.923|TWO_SIDED|95.0|-0.26|0.29|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.29|-0.26|0.9230
71682155|NCT02431806|142882248|SUPERIORITY||LS Mean Difference|-0.15||||0.2895|TWO_SIDED|95.0|-0.42|0.13|||MMRM||Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.|||0.13|-0.42|0.2895
71682156|NCT05072106|142882300|OTHER|Bioequivalence|Least-squares geometric mean ratio|96.83|||||TWO_SIDED|90.0|81.09|115.62|||||The reported results are the same as the ones reported in the CSR of the trial.|||115.62|81.09|
71682157|NCT05072106|142882301|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.81|||||TWO_SIDED|90.0|64.78|98.32||||||||98.32|64.78|
71682158|NCT05072106|142882302|OTHER|Bioequivalence|Least-squares geometric mean ratio|79.2|||||TWO_SIDED|90.0|64.12|97.82||||||||97.82|64.12|
71682159|NCT05072106|142882303|OTHER|Bioequivalence|Least-squares geometric mean ratio|125.3|||||TWO_SIDED|90.0|101.71|154.36||||||||154.36|101.71|
71682160|NCT05072106|142882304|OTHER|Bioequivalence|Least-squares geometric mean ratio|106.79|||||TWO_SIDED|90.0|74.63|152.8||||||||152.8|74.63|
71682161|NCT05072106|142882305|OTHER|Bioequivalence|Least-squares geometric mean ratio|104.93|||||TWO_SIDED|90.0|69.49|158.44||||||||158.44|69.49|
71682162|NCT05072106|142882306|OTHER|bioequivalence|Least-squares geometric mean ratio|88.44|||||TWO_SIDED|90.0|65.62|119.19||||||||119.19|65.62|
71682163|NCT05072106|142882307|OTHER|bioequivalence|Least-squares geometric mean ratio|81.8|||||TWO_SIDED|90.0|54.8|119.96||||||||119.96|54.8|
71682164|NCT05072106|142882308|OTHER|bioequivalence|Least-squares geometric mean ratio|80.26|||||TWO_SIDED|90.0|54.26|118.72||||||||118.72|54.26|
71682165|NCT05072106|142882309|OTHER|bioequivalence|Least-squares geometric mean ratio|123.34|||||TWO_SIDED|90.0|83.36|182.49||||||||182.49|83.36|
71682166|NCT05072106|142882310|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
71682167|NCT05072106|142882311|OTHER|bioequivalence|Least-squares geometric mean ratio|120.5|||||TWO_SIDED|90.0|64.79|224.13||||||||224.13|64.79|
71682168|NCT05072106|142882312|OTHER|bioequivalence|Least-squares geometric mean ratio|188.13|||||TWO_SIDED|90.0|132.93|266.26||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized Cmax.||266.26|132.93|
71682169|NCT05072106|142882313|OTHER|bioequivalence|Least-squares geometric mean ratio|245.46|||||TWO_SIDED|90.0|133.4|451.65||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M1 dose-normalized AUC0-t.||451.65|133.4|
71682170|NCT05072106|142882314|OTHER|bioequivalence|Least-squares geometric mean ratio|104.94|||||TWO_SIDED|90.0|94.07|117.05||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized Cmax.||117.05|94.07|
71682171|NCT05072106|142882315|OTHER|bioequivalence|Least-squares geometric mean ratio|91.02|||||TWO_SIDED|90.0|71.39|116.04||||||PK parameter used was the log-transformed metabolite/parent ratio (MPR) of M4 dose-normalized AUC0-t.||116.04|71.39|
71682172|NCT02304380|142882330|OTHER||Difference in differences|-0.0064|||||TWO_SIDED|95.0|-0.0469|0.034|||||Linear model difference in incidences.|||0.0340|-0.0469|
71682173|NCT02304380|142882331|OTHER||Difference in Differences|0.0506|||||TWO_SIDED|95.0|0.029|0.0722|||||Linear model difference in incidences.|||0.0722|0.0290|
71682174|NCT02304380|142882332|OTHER||Difference in Differences|-0.0005|||||TWO_SIDED|95.0|-0.0109|0.0099|||||Linear model difference in incidences.|||0.0099|-0.0109|
71864894|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.0|||||TWO_SIDED|95.0|-1.1|1.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19A||1.1|-1.1|
71864895|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|0.2|||||TWO_SIDED|95.0|-0.9|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 19F||1.4|-0.9|
71864896|NCT04546425|143244816|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC is to the corresponding serotype in 13vPnC group.|Percent difference|-0.9|||||TWO_SIDED|95.0|-3.2|1.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 23F||1.4|-3.2|
71864897|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 8||3.9|0.4|
71864898|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|0.6|||||TWO_SIDED|95.0|-1.5|2.7|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 10A||2.7|-1.5|
71864899|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.2|||||TWO_SIDED|95.0|-0.7|3.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 11A||3.2|-0.7|
71864900|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|-0.6|||||TWO_SIDED|95.0|-2.9|1.6|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 12F||1.6|-2.9|
71864901|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.2|||||TWO_SIDED|95.0|0.7|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 15B||4.1|0.7|
71864902|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F(13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|2.0|||||TWO_SIDED|95.0|0.4|3.9|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 22F||3.9|0.4|
71910496|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7148|TWO_SIDED|95.0|0.82|1.66||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.66|0.82|0.7148
71864903|NCT04546425|143244816|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC serotype with the lowest percentage, not including serotype 3) in the 13vPnC group.|Percent difference|1.4|||||TWO_SIDED|95.0|-0.4|3.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.|Serotype 33F||3.4|-0.4|
71864904|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.5|||||TWO_SIDED|95.0|-11.2|2.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Diphtheria||2.1|-11.2|
71864905|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.0|||||TWO_SIDED|95.0|-7.0|0.4|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Tetanus||0.4|-7.0|
71910497|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.7907|TWO_SIDED|95.0|0.75|1.45||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.45|0.75|0.7907
71910498|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.4765|TWO_SIDED|95.0|0.81|1.6||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.60|0.81|0.4765
71910499|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5037|TWO_SIDED|95.0|0.89|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.89|0.5037
71910500|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.52|2.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.17|0.52|0.9414
71910501|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.45|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.45|0.7907
71910502|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.29|TWO_SIDED|95.0|0.32|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.32|0.2900
71864906|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-0.5|||||TWO_SIDED|95.0|-5.2|4.1|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PT||4.1|-5.2|
71682175|NCT02304380|142882333|OTHER||Difference in differences|-0.0207|||||TWO_SIDED|95.0|-0.0318|0.0096||||||||0.0096|-0.0318|
71682176|NCT02304380|142882334|OTHER||Difference in differences|0.0163|||||TWO_SIDED|95.0|0.0036|0.0289|||||Linear model difference in incidences.|||0.0289|0.0036|
71682177|NCT02304380|142882335|OTHER||Difference in differences|0.0046|||||TWO_SIDED|95.0|-0.002|0.0111|||||||Linear model difference in incidences.|0.0111|-0.0020|
71682178|NCT02304380|142882336|OTHER||Difference in differences|0.0151|||||TWO_SIDED|95.0|-0.0129|0.0431|||||Linear model difference in incidences.|||0.0431|-0.0129|
71682179|NCT02304380|142882337|OTHER||Difference in Differences|-0.0066|||||TWO_SIDED|95.0|-0.0328|0.0197|||||Linear model difference in incidences.|||0.0197|-0.0328|
71682180|NCT02304380|142882338|OTHER||Difference in Differences|-0.0105|||||TWO_SIDED|95.0|-0.0374|0.0163|||||Linear model difference in incidences.|||0.0163|-0.0374|
71682181|NCT02304380|142882339|OTHER||Difference in Differences|0.0006|||||TWO_SIDED|95.0|-0.0031|0.0044|||||Linear model difference in incidences.|||0.0044|-0.0031|
71864907|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|FHA||3.3|-6.4|
71864908|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-1.5|||||TWO_SIDED|95.0|-6.4|3.3|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|PRN||3.3|-6.4|
71864909|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-3.3|||||TWO_SIDED|95.0|-10.0|2.2|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 1||2.2|-10.0|
71864910|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-2.8|||||TWO_SIDED|95.0|-11.8|5.8|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 2||5.8|-11.8|
71864911|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|-4.2|||||TWO_SIDED|95.0|-10.2|-0.5|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Poliovirus Type 3||-0.5|-10.2|
71864912|NCT04546425|143244820|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC/13vPnC) was greater than 0.5 (2-fold criterion).|Percent difference|0.0|||||TWO_SIDED|95.0|-1.8|2.0|||||2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions (20vPnC - 13vPnC) expressed as a percentage.|Hib||2.0|-1.8|
71864913|NCT01399697|143244873|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||ANCOVA|||||||0.700
71682182|NCT02304380|142882340|OTHER||Difference in Differences|-0.0293|||||TWO_SIDED|95.0|-0.1025|0.044||||Linear model difference in incidences.||||0.0440|-0.1025|
71682183|NCT02304380|142882341|OTHER||Difference in Differences|-0.0579|||||TWO_SIDED|95.0|-0.1492|0.0116|||||Linear model difference in incidences.|||0.0116|-0.1492|
71864914|NCT01399697|143244874|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Chi-squared|||||||0.328
71682184|NCT02304380|142882342|OTHER||Difference in differences|0.0072|||||TWO_SIDED|95.0|0.001|0.0134|||||Linear model difference in incidences.|||0.0134|0.0010|
71864915|NCT01399697|143244875|SUPERIORITY_OR_OTHER|||||||0.518|TWO_SIDED||||||Chi-squared|||||||0.518
71864916|NCT01399697|143244876|SUPERIORITY_OR_OTHER|||||||0.358|TWO_SIDED||||||Chi-squared|||||||0.358
71682185|NCT02304380|142882343|OTHER||Difference in Differences|0.0058|||||TWO_SIDED|95.0|0.0009|0.0107||||||||0.0107|0.0009|
71682186|NCT02304380|142882344|OTHER||Difference in Differences|0.0054|||||TWO_SIDED|95.0|0.0001|0.0106|||||Linear model difference in incidences.|||0.0106|0.0001|
71682187|NCT02304380|142882345|OTHER||Difference in Differences|-0.0039|||||TWO_SIDED|95.0|-0.0096|0.0017|||||Linear model difference in incidences.|||0.0017|-0.0096|
71682188|NCT02304380|142882346|OTHER||Difference in Differences|-0.011|||||TWO_SIDED|95.0|-0.0178|-0.0043|||||Linear model difference in incidences.|||-0.0043|-0.0178|
71682189|NCT02304380|142882347|OTHER||Difference in Differences|0.0026|||||TWO_SIDED|95.0|-0.0036|0.0086|||||Linear model difference in incidences.|||0.0086|-0.0036|
71682190|NCT02304380|142882348|OTHER||Difference in differences|0.0197|||||TWO_SIDED|95.0|0.011|0.0284|||||Linear model difference in incidences.|||0.0284|0.0110|
71682191|NCT02102100|142882349|OTHER||Mean Difference (Net)|0.9436|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Least square means and standard errors were calculated to describe the patterns of means for each outcome. Effect slices were tested to explain significant interactions in the models. Pairwise comparisons of least square means were used to describe significant main effects.||||<.0001
71682192|NCT00328094|142882350|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29||||0.23|TWO_SIDED|95.0|0.85|1.97|||Chi-squared|||||1.97|0.85|0.23
71682193|NCT00985426|142882362|NON_INFERIORITY|Non-inferiority is achieved if the lower limit of the two-sided 95% CI was greater than -10%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3|||||SPR difference = SPR for HEPLISAV-B minus SPR for Engerix-B.|Two-sided 95% confidence intervals (CIs) of the difference in seroprotection rates (SPR) between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
71682194|NCT00985426|142882362|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|8.0|||||TWO_SIDED|95.0|1.7|14.3||||||Two-sided 95% CIs of the difference in SPR between the HEPLISAV-B group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||14.3|1.7|
71682195|NCT00985426|142882367|SUPERIORITY|Superiority is achieved if the lower limit of the two-sided 95% CI was greater than 0%.|SPR Difference (%)|12.9|||||TWO_SIDED|95.0|4.4|21.2||||||Two-sided 95% CIs of the difference in SPRs between the HEPLISAV group and the Engerix-B group at 28 weeks was computed using the Newcombe score method with continuity correction.||21.2|4.4|
71910503|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.44|1.77||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.77|0.44|0.8826
71910504|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.5823|TWO_SIDED|95.0|0.18|1.4||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.40|0.18|0.5823
71910505|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.27|1.8||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.80|0.27|0.7636
71910506|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.4||||0.2407|TWO_SIDED|95.0|0.14|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.14|0.2407
71910507|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.8826|TWO_SIDED|95.0|0.43|3.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||3.22|0.43|0.8826
71910508|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.5||||0.0961|TWO_SIDED|95.0|0.26|0.81||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.81|0.26|0.0961
71910509|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.7636|TWO_SIDED|95.0|0.38|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.38|0.7636
71910510|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.29|TWO_SIDED|95.0|0.39|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.39|0.2900
71758550|NCT02205736|143019222|SUPERIORITY|||||||0.285||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 17 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.2850
71910511|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.8826|TWO_SIDED|95.0|0.6|1.82||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.82|0.60|0.8826
71910512|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.0||||0.9925|TWO_SIDED|95.0|0.65|1.54||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.54|0.65|0.9925
71910513|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.52|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.52|0.7636
71910514|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3929|TWO_SIDED|95.0|0.53|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.53|0.3929
71910515|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.62|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.62|0.8826
71864917|NCT01399697|143244877|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Mean|0.032||||0.674|TWO_SIDED|95.0|-0.119|0.184|||ANCOVA||Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.|||0.184|-0.119|0.674
71864918|NCT01399697|143244878|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.873||||0.204|TWO_SIDED|95.0|-4.775|1.03|||ANCOVA||ANCOVA model with treatment as factor and mental component score (MCS) as covariate.|||1.030|-4.775|0.204
71864919|NCT01399697|143244879|SUPERIORITY_OR_OTHER||Difference in LS Mean|3.376||||0.015|TWO_SIDED|95.0|0.676|6.076|||ANCOVA||ANCOVA model with treatment as factor and physical component score (PCS) as covariate.|||6.076|0.676|0.015
71864920|NCT01399697|143244880|SUPERIORITY_OR_OTHER||Difference in LS Mean|0.969||||0.769|TWO_SIDED|95.0|-5.526|7.464|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.|||7.464|-5.526|0.769
71864921|NCT01399697|143244881|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.216||||0.655|TWO_SIDED|95.0|-6.573|4.141|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.|||4.141|-6.573|0.655
71864922|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.86||||0.0648|TWO_SIDED|95.0|0.75|0.99||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group||0.99|0.75|0.0648
71864923|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.85||||0.0241|TWO_SIDED|95.0|0.74|0.98||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group||0.98|0.74|0.0241
71864924|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Cox Proportional Hazard|0.93||||0.1895|TWO_SIDED|95.0|0.8|1.07||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE|H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.||1.07|0.80|0.1895
71864925|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.572|TWO_SIDED|95.0|0.77|1.16||2-sided unadjusted p-value|Regression, Cox||CV death|||1.16|0.77|0.572
71864926|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.296|TWO_SIDED|95.0|0.73|1.1||2-sided unadjusted p-value|Regression, Cox||CV death|||1.10|0.73|0.296
71864927|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.91||||0.369|TWO_SIDED|95.0|0.73|1.12||2-sided unadjusted p-value|Regression, Cox||CV death|||1.12|0.73|0.369
71864928|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.84||||0.067|TWO_SIDED|95.0|0.69|1.01||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.01|0.69|0.067
71864929|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76||||0.006|TWO_SIDED|95.0|0.63|0.92||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||0.92|0.63|0.006
71864930|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.542|TWO_SIDED|95.0|0.78|1.14||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)|||1.14|0.78|0.542
71864931|NCT01327846|143244910|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.68|1.0|||||MI (non-fatal)|||1.00|0.68|
71864932|NCT01327846|143244910|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.62|0.92|||||MI (non-fatal)|||0.92|0.62|
71864933|NCT01327846|143244910|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.78|1.14|||||MI (non-fatal)|||1.14|0.78|
71910516|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7433|TWO_SIDED|95.0|0.7|2.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.20|0.70|0.7433
71910517|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.7636|TWO_SIDED|95.0|0.46|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.35|0.46|0.7636
71910518|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.2407|TWO_SIDED|95.0|0.34|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.34|0.2407
71910519|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8826|TWO_SIDED|95.0|0.61|1.83||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.83|0.61|0.8826
71864934|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8||||0.19|TWO_SIDED|95.0|0.56|1.12||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.12|0.56|0.190
71864935|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.912|TWO_SIDED|95.0|0.71|1.35||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.35|0.71|0.912
71864936|NCT01327846|143244910|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.03||||0.871|TWO_SIDED|95.0|0.74|1.43||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)|||1.43|0.74|0.871
71864937|NCT01327846|143244910|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.57|1.13|||||Stroke (nonfatal)|||1.13|0.57|
71910520|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.9414|TWO_SIDED|95.0|0.51|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.71|0.51|0.9414
71910521|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.2||||0.7636|TWO_SIDED|95.0|0.68|2.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.14|0.68|0.7636
71910522|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.738|TWO_SIDED|95.0|0.5|1.63||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.63|0.50|0.7380
71682196|NCT02327013|142882368|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|1.8||0.9723|TWO_SIDED|95.0|-3.6|3.5|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.||3.5|-3.6|0.9723
71864938|NCT01327846|143244910|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.72|1.37|||||Stroke (nonfatal)|||1.37|0.72|
71682197|NCT02327013|142882368|SUPERIORITY|The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|Mean Difference (Final Values)|1.0|STANDARD_DEVIATION|1.9||0.601|TWO_SIDED|95.0|-2.8|4.8|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||||4.8|-2.8|0.6010
71682198|NCT00355706|142882436|SUPERIORITY_OR_OTHER_LEGACY|||||||0.964||95.0|||||ANOVA|||||||0.964
71864939|NCT01327846|143244910|OTHER|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.75|1.45|||||Stroke (nonfatal)|||1.45|0.75|
71864940|NCT01327846|143244913|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.82||||0.0648|TWO_SIDED|95.0|0.72|0.94||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.94|0.72|0.0648
71864941|NCT01327846|143244913|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.83||||0.0241|TWO_SIDED|95.0|0.73|0.95||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||0.95|0.73|0.0241
71682199|NCT00355706|142882437|SUPERIORITY_OR_OTHER_LEGACY|||||||0.892||95.0|||||ANOVA|||||||0.892
71682200|NCT00355706|142882438|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||95.0|||||ANOVA|||||||0.560
71864942|NCT01327846|143244913|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.1895|TWO_SIDED|95.0|0.79|1.03||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank||MACE or unstable angina|||1.03|0.79|0.1895
71864943|NCT01327846|143244913|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.58||||0.007|TWO_SIDED|95.0|0.39|0.86||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.86|0.39|0.007
71864944|NCT01327846|143244913|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.64||||0.022|TWO_SIDED|95.0|0.44|0.94||2-sided unadjusted p-value|Regression, Cox||unstable angina|||0.94|0.44|0.022
71864945|NCT01327846|143244913|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.71||||0.086|TWO_SIDED|95.0|0.48|1.05||2-sided unadjusted p-value|Regression, Cox||unstable angina|||1.05|0.48|0.086
71864946|NCT01327846|143244914|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.01||||0.8456|TWO_SIDED|95.0|0.83|1.23||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.23|0.83|0.8456
71864947|NCT01327846|143244914|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|1.06||||0.8456|TWO_SIDED|95.0|0.87|1.29||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.29|0.87|0.8456
71864948|NCT01327846|143244914|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.6541|TWO_SIDED|95.0|0.8|1.2||1-sided adjusted for multiplicity using weighted Dunnett test. \[significance level 0.0245\]|Log Rank|||||1.20|0.80|0.6541
71864949|NCT01327846|143244915|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.028|TWO_SIDED|95.0|0.77|0.99||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.99|0.77|0.028
71864950|NCT01327846|143244915|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.011|TWO_SIDED|95.0|0.75|0.96||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||0.96|0.75|0.011
71864951|NCT01327846|143244915|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.377|TWO_SIDED|95.0|0.83|1.07||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke|||1.07|0.83|0.377
71864952|NCT01327846|143244916|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.93||||0.406|TWO_SIDED|95.0|0.79|1.1||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.10|0.79|0.406
71864953|NCT01327846|143244916|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.92||||0.329|TWO_SIDED|95.0|0.78|1.09||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.09|0.78|0.329
71864954|NCT01327846|143244916|SUPERIORITY|A HR \< 1 favors Canakinumab|Hazard Ratio (HR)|0.96||||0.597|TWO_SIDED|95.0|0.81|1.13||2-sided unadjusted p-value|Regression, Cox||All-cause mortality|||1.13|0.81|0.597
71864955|NCT03617835|143244974|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.67|||||TWO_SIDED|90.0|78.48|111.8|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||111.80|78.48|
71864956|NCT03617835|143244974|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.95|||||TWO_SIDED|90.0|117.26|167.03|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.03|117.26|
71864957|NCT03617835|143244975|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.84|||||TWO_SIDED|90.0|102.08|145.41|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.0.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.41|102.08|
71864958|NCT03617835|143244976|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|99.17|||||TWO_SIDED|90.0|83.77|117.39|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||117.39|83.77|
71864959|NCT03617835|143244976|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|156.2|||||TWO_SIDED|90.0|131.95|184.9|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||184.90|131.95|
71864960|NCT03617835|143244977|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|138.34|||||TWO_SIDED|90.0|116.87|163.77|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 24.8.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||163.77|116.87|
71864961|NCT03617835|143244978|OTHER|Relative bioavailability|Ratio of the geometric means (T1/R) [%]|93.58|||||TWO_SIDED|90.0|78.11|112.11|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||112.11|78.11|
71682201|NCT01313494|142882442|SUPERIORITY_OR_OTHER||LSM Difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.095|||Repeated measures ANCOVA|Independent variables: treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction.||The primary endpoint was tested in a confirmatory manner with a 2-sided significance level of 5%.||0.095|0.046|<0.0001
71682202|NCT00956631|142882466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2|||<|0.0001|TWO_SIDED|95.0|2.29|4.13|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.||4.13|2.29|<0.0001
71682203|NCT00956631|142882467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.58|||<|0.0001|TWO_SIDED|95.0|12.33|22.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.||22.83|12.33|<0.0001
71864962|NCT03617835|143244978|OTHER|Relative bioavailability|Ratio of the geometric means (T2/R) [%]|139.73|||||TWO_SIDED|90.0|116.64|167.4|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||167.40|116.64|
71864963|NCT03617835|143244979|OTHER|Relative bioavailability|Ratio of the geometric means (T3/R) [%]|121.34|||||TWO_SIDED|90.0|101.28|145.37|||||The geometric means are adjusted by treatment. The geometric Coefficient of (within matched pair) Variation (gCV) \[%\] = 26.6.|Exploratory trial, no formal hypotheses were tested. Analysis of Variance (ANOVA) model on the logarithmic scale was used which included effects accounting for sources of variation: 'treatment' (fixed effect), 'matched pair' (random effect). For each matched pair in the study (participant in test treatment group matched to participant in reference treatment group), a pair number was assigned for analysis purpose.||145.37|101.28|
71864964|NCT04608773|143244982|SUPERIORITY||||||<|0.501|||||||ANCOVA|||Null hypothesis is that there was no difference in change of Dry mouth score between Refresh and Biotene. ANCOVA model was performed by regressing the difference in after-treatment measurement between Refresh and Biotene over the difference of baseline between Refresh and Biotene. The test was performed with a significance level of 0.05 (two- sided)||||<0.501
71864965|NCT04608773|143244983|SUPERIORITY|||||||0.109|||||||ANCOVA|||||||.109
71864966|NCT04608773|143244984|SUPERIORITY|||||||0.107|||||||ANCOVA|||||||.107
71864967|NCT04608773|143244985|SUPERIORITY|||||||0.489|||||||ANCOVA|||||||.489
71864968|NCT04608773|143244986|SUPERIORITY|||||||0.213|||||||ANCOVA|||||||.213
71864969|NCT04608773|143244987|SUPERIORITY|||||||0.486|||||||ANCOVA|||||||.486
71864970|NCT02387970|143244989|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71864971|NCT02387970|143244990|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
71682204|NCT03422159|142882469|NON_INFERIORITY|Based on the results of the preliminary study of Marik et al, 5 we projected that the combination of ascorbic acid, thiamine, and hydrocortisone could reduce time to vasopressor discontinuation from 54 (+/-30 hours) vs 30 hours. For the additional primary outcome, we projected a greater change of SOFA score of 4 (+/-3) vs 2. Assuming a type 1 error of 5% (alpha of 0.05) and a power of 80%, this study would require a sample size of 94 patients.|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71682205|NCT01256385|142882531|SUPERIORITY_OR_OTHER|||||||0.73|||||||Log Rank|||||||0.73
71864972|NCT02387970|143244991|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||||||0.165
71864973|NCT02387970|143244992|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
71864974|NCT02387970|143244993|SUPERIORITY|||||||0.121|||||||t-test, 2 sided|||||||0.121
71864975|NCT02387970|143244994|SUPERIORITY|||||||0.248|||||||t-test, 2 sided|||||||0.248
71864976|NCT02387970|143244995|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
71864977|NCT01310231|143244996|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.71|TWO_SIDED|95.0|0.63|2.31||One-sided p-value for group-effect obtained from Cox model. The prespecified threshold was 0.20 (one-sided).|Regression, Cox|Cox model for PFS with metf/plac and the two randomization stratification variables line of chemotherapy and hormone receptor status.|Ratio of hazard of progression in the Metformin group relative to hazard in the Placebo group|Power: Final study plan called for 40 progression events, giving 80% power to detect a hazard ratio (HR) of 0.58 for PFS with a one-sided type I error of 20%, where the relatively high type I error reflects the Phase II status of the trial||2.31|0.63|0.71
71864978|NCT01310231|143244997|SUPERIORITY||Odds Ratio (OR)|1.77||||0.41|TWO_SIDED|95.0|0.45|6.99||Two-side p-value from a logistic regression model.|Regression, Logistic|Logistic regression model included metf/plac and the two stratification variables line of chemotherapy and hormone receptor status.||||6.99|0.45|0.41
71864979|NCT04662060|143245006|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
71864980|NCT04662060|143245007|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
71864981|NCT04662060|143245009|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
71864982|NCT04662060|143245010|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
71682206|NCT01256385|142882532|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
71682207|NCT01256385|142882533|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
71682208|NCT01256385|142882534|SUPERIORITY|||||||0.006|||||||Chi-squared|||PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.006
71682209|NCT01256385|142882534|SUPERIORITY|||||||0.037||||||1-sided.|Chi-squared|||PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).||||0.037
71682210|NCT01256385|142882535|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
71682211|NCT00725101|142882591|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P-value for age over 65.|Regression, Logistic|||||||0.0074
71682212|NCT00725101|142882591|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||P-value for female physicians.|Regression, Logistic|||||||0.0028
71682213|NCT00725101|142882591|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Rheumatology versus PCP.|Regression, Logistic|||||||<0.0001
71910523|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.49|1.58||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.58|0.49|0.8826
71910524|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.9414|TWO_SIDED|95.0|0.67|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.67|0.9414
71910525|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7907|TWO_SIDED|95.0|0.58|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.58|0.7907
71910526|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2407|TWO_SIDED|95.0|0.43|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.43|0.2407
71910527|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.02||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.02|0.42|0.2670
71910528|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.62|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.62|0.5823
71910529|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.65|0.7636
71910530|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.6||||0.0422|TWO_SIDED|95.0|0.48|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.86|0.48|0.0422
71910531|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.53|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.53|0.2670
71910532|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.8454|TWO_SIDED|95.0|0.72|1.78||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.78|0.72|0.8454
71910533|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.7636|TWO_SIDED|95.0|0.81|2.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.00|0.81|0.7636
71910534|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2824|TWO_SIDED|95.0|0.45|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.45|0.2824
71910535|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.3||||0.5155|TWO_SIDED|95.0|0.83|2.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||2.06|0.83|0.5155
71910536|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.5823|TWO_SIDED|95.0|0.5|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.50|0.5823
71682214|NCT00725101|142882591|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for other specialty versus PCP.|Regression, Logistic|||||||<0.0001
71910537|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7636|TWO_SIDED|95.0|0.78|1.7||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.70|0.78|0.7636
71910538|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.4644|TWO_SIDED|95.0|0.56|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.56|0.4644
71922172|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-7.74|STANDARD_ERROR_OF_MEAN|3.51|||TWO_SIDED|95.0|-15.03|-0.44|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-0.44|-15.03|
71682215|NCT00725101|142882591|SUPERIORITY_OR_OTHER|||||||0.0064||95.0||||P-value for use of opioids.|Regression, Logistic|||||||0.0064
71682216|NCT00725101|142882591|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for use of NSAIDs.|Regression, Logistic|||||||<0.0001
71682217|NCT00725101|142882591|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for number of medications participants were taking.|Regression, Logistic|||||||<0.0001
71682218|NCT00725101|142882592|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||P-value for GAD-7 score.|Regression, Logistic|||||||0.026
71864983|NCT04662060|143245011|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
71864984|NCT04531982|143245039|SUPERIORITY|||||||0.4825||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||Difference between LSM changes for adjunctive pimavanserin and adjunctive placebo (pimavanserin - placebo) at the specified visit from MMRM analysis.||||0.4825
71682219|NCT00725101|142882592|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pregabalin use.|Regression, Logistic|||||||0.021
71682220|NCT00725101|142882592|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for NSAID use.|Regression, Logistic|||||||0.050
71682221|NCT02889835|142882644|SUPERIORITY|||||||0.686|||||||Log Rank|||Kaplan-Meier analysis was performed to assess survival over 36 months. Test of survival distributions for the three arms were calculated using Log Rank (Mantel-Cox). Sample size is based on guidelines of the American Dental Association for obtaining approval as an amalgam replacement for posterior restorations - minimum of 40 restorations in a minimum of 20 subjects at 18 months. Sample size is based by taking subject attrition into account over the 36 month clinical evaluation.||||0.686
71682222|NCT02889835|142882645|SUPERIORITY|||||||0.701|||||||Kruskal-Wallis|||||||0.701
71864985|NCT04531982|143245040|SUPERIORITY|||||||0.8872||||||Two-sided p-value for treatment difference at Week 26 from MMRM analysis.|Mixed Models Analysis|||||||0.8872
71864986|NCT03841526|143245042|OTHER|Parameters that did not meet normality criterion were analyzed non-parametrically. Overall treatment effect was assessed using Friedman's test.||||||0.0002|||||||ANOVA|||The primary efficacy analysis was analyzed by analysis of variance (ANOVA) comparing the mean incidence rates among the 3 treatment groups in the Outpatient Phase. If the performed Friedman's test yielded an overall p-value less than 0.05, post-hoc analysis of groups means were conducted to statistically determine which group means differed.||||0.0002
71864987|NCT03841526|143245042|OTHER||||||<|0.0001|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||<0.0001
71864988|NCT03841526|143245042|OTHER|||||||0.0032|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.0032
71864989|NCT03841526|143245042|OTHER|||||||0.2072|||||||Tukey Test/Kruskal-Wallis Test|Tukey Test (if the difference between 2 treatments was normally distributed) or Kruskal-Wallis Test (if not normally distributed).||If the overall treatment effect was significant, pairwise treatment comparisons were assessed using: If a difference between 2 treatments was normally distributed, the Tukey Test was used or if not normally distributed and the distribution was highly skewed, the sign test/Kruskal-Allis test was used.||||0.2072
71864990|NCT03841526|143245045|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71682223|NCT02889835|142882646|SUPERIORITY|||||||0.812|||||||Kruskal-Wallis|||||||0.812
71864991|NCT03841526|143245046|OTHER|||||||0.859|||||||Chi-squared|||||||0.8590
71864992|NCT04266795|143245054|SUPERIORITY||Hazard Ratio (HR)|0.99|||=|0.477|TWO_SIDED|95.0|0.61|1.6|||Log Rank|P-value was comparison of EFS between treatment groups and was based on the 1-sided stratified log-rank test statistic.|Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (randomization strata of age and AML subtype) and treatment as a factor in the model.|||1.60|0.61|=0.477
71864993|NCT03317990|143245146|SUPERIORITY||Mean Difference (Final Values)|3.18|||<|0.0001|TWO_SIDED|95.0|1.62|4.75|||Regression, Linear|||Normal linear regression model adjusted for recruitment site, participant's age, and IIEF-5 at baseline, in participants with available data||4.75|1.62|<0.0001
71864994|NCT03317990|143245147|SUPERIORITY||Mean Difference (Final Values)|-1.41||||0.006|TWO_SIDED|95.0|-2.42|-0.41|||Regression, Linear|||||-0.41|-2.42|0.006
71864995|NCT04833127|143245187|EQUIVALENCE|Null hypothesis: no difference between the groups|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.56|1.8||generalized linear models (GLM) and generalized estimating equations (GEE) for clustering within recruitment chain|GLM (logit link) with GEE|||||1.80|0.56|1.0
71864996|NCT04833127|143245187|EQUIVALENCE|Null H: No difference between the groups|Odds Ratio (OR)|1.13||||0.69|TWO_SIDED|95.0|0.62|2.07||GLM with GEE to account for clustering by recruitment chain.|GLM (logit link) with GEE|Adjusted for age, education, if has a main male partner, which differed between the two groups at baseline.||||2.07|0.62|0.69
71864997|NCT04833127|143245188|EQUIVALENCE|Null hypothesis: No difference between the groups.|Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.35|2.85|||GLM with GEE|GLM with GEE accounting for clustering by recruitment chain||||2.85|0.35|1.00
71864998|NCT04833127|143245188|EQUIVALENCE|Null H: No difference between the 2 groups|Odds Ratio (OR)|0.95||||0.927|TWO_SIDED|95.0|0.31|2.9||GLM (logit link) with GEE to account for clustering by recruitment chain|GLM (logit link) with GEE|adjusted for baseline differences in age, educational status, and whether has a primary male partner.||||2.90|0.31|0.927
71864999|NCT04833127|143245189|EQUIVALENCE|Null Hypothesis: No difference between the groups|Odds Ratio (OR)|1.72||||0.215|TWO_SIDED|95.0|0.73|4.04|||GLM (logit link) with GEE|Used GEE to account for clustering by recruitment chain.||||4.04|0.73|0.215
71865000|NCT04833127|143245189|EQUIVALENCE|Null hypothesis: No difference between the groups|Odds Ratio (OR)|1.64||||0.295|TWO_SIDED|95.0|0.65|4.13|||GLM (logit link) with GEE|GEE used to account for clustering by recruitment chain|adjusted for baseline differences in age, education, and whether has a main male partner.|||4.13|0.65|0.295
71865001|NCT04552899|143245194|SUPERIORITY||Difference in Change from Baseline|-20.83|STANDARD_ERROR_OF_MEAN|34.11||0.54|TWO_SIDED|95.0|-87.94|46.29|||RCRM|Random Coefficient Regression Model (RCRM)||||46.29|-87.94|0.54
71682224|NCT02889835|142882647|SUPERIORITY|||||||0.104|||||||Kruskal-Wallis|||||||0.104
71682225|NCT02889835|142882648|SUPERIORITY|||||||0.44|||||||Kruskal-Wallis|||||||0.440
71865002|NCT04552899|143245197|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.2512|TWO_SIDED|95.0|0.91|1.47|||Log Rank|||||1.47|0.91|0.2512
71865003|NCT04552899|143245198|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9833|TWO_SIDED|95.0|0.51|1.97|||Log Rank|||||1.97|0.51|0.9833
71865004|NCT04552899|143245201|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.7005|TWO_SIDED|95.0|0.4|1.86|||Log Rank|||||1.86|0.40|0.7005
71910539|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.8826|TWO_SIDED|95.0|0.59|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.59|0.8826
71910540|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.61|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.61|0.5823
71910541|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.9||||0.7636|TWO_SIDED|95.0|0.65|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.65|0.7636
71910542|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.3299|TWO_SIDED|95.0|0.6|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.13|0.60|0.3299
71910543|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.54|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.03|0.54|0.2670
71910544|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.5823|TWO_SIDED|95.0|0.48|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.48|0.5823
71682226|NCT02889835|142882649|SUPERIORITY|||||||0.676|||||||Kruskal-Wallis|||||||0.676
71682227|NCT02889835|142882650|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
71682228|NCT02889835|142882651|SUPERIORITY|||||||0.764|||||||Kruskal-Wallis|||||||0.764
71682229|NCT02889835|142882652|SUPERIORITY|||||||0.323|||||||Kruskal-Wallis|||||||0.323
71682230|NCT02889835|142882653|SUPERIORITY|||||||0.714|||||||Kruskal-Wallis|||||||0.714
71682231|NCT02889835|142882654|SUPERIORITY|||||||0.846|||||||Kruskal-Wallis|||||||0.846
71682232|NCT02889835|142882655|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||||||1.000
71682233|NCT02889835|142882656|SUPERIORITY|||||||0.424|||||||Kruskal-Wallis|||||||0.424
71865005|NCT00461981|143245221|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.6||||||95.0|-79.7|-31.7||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-31.7|-79.7|
71865006|NCT00461981|143245222|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-60.9||||||95.0|-83.8|-26.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-26.0|-83.8|
71865007|NCT00461981|143245223|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|44.2||||||95.0|12.0|67.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||67.8|12.0|
71682234|NCT02502266|142882704|SUPERIORITY||Hazard Ratio (HR)|0.649|||||TWO_SIDED|95.0|0.424|0.995|||||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||0.995|0.424|
71682235|NCT02502266|142882704|SUPERIORITY||Hazard Ratio (HR)|0.832|||||TWO_SIDED|95.0|0.539|1.284|||||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.284|0.539|
71682236|NCT02502266|142882704|SUPERIORITY||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.745|1.773|||||The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \<1.0.|Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \< 0.83) were recommended for further evaluation in the phase III trial.||1.773|0.745|
71682237|NCT02502266|142882705|SUPERIORITY||Hazard Ratio (HR)|0.796||||0.145|TWO_SIDED|98.0|0.597|1.06||The log rank test was stratified by the factors provided at randomization|Log Rank||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.060|0.597|0.145
71682238|NCT02502266|142882705|SUPERIORITY||Hazard Ratio (HR)|0.972||||1|TWO_SIDED|98.0|0.726|1.0|||Log Rank|The log rank test was stratified by the factors provided at randomization.|The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.00|0.726|1.0
71682239|NCT02502266|142882706|SUPERIORITY||Hazard Ratio (HR)|1.027|||||TWO_SIDED|98.0|0.771|1.368||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.368|0.771|
71682240|NCT02502266|142882706|OTHER|No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|Hazard Ratio (HR)|1.06|||||TWO_SIDED|98.0|0.795|1.413||No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.|||The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.|Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.||1.413|0.795|
71682241|NCT02921750|142882714|NON_INFERIORITY|In this non-inferiority study the primary efficacy analysis included constructing a two sided 95% confidence interval, using Fisher's non-parametric permutation test, for between-treatment differences (Exufiber - Aquacel Extra) in the mean percentage area change from baseline to 6 weeks. This means that if the lower limit of this confidence interval was found to be greater than 12%, non-inferiority will be established.|Mean Difference (Final Values)|-29.4||||0.093|TWO_SIDED|95.0|-63.5|3.2|||Fisher Exact|||||3.2|-63.5|0.093
71682242|NCT04007107|142882878|OTHER|Comparison|Estimated treatment difference|30.7|||<|0.0001|TWO_SIDED|95.0|26.6|34.8|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||34.8|26.6|<0.0001
71682243|NCT04068688|142882879|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71682244|NCT04068688|142882879|OTHER|||||||0.914|||||||Wilcoxon (Mann-Whitney)|||||||0.914
71682245|NCT04068688|142882880|OTHER|||||||0.655|||||||Wilcoxon (Mann-Whitney)|||||||0.655
71682246|NCT04068688|142882880|OTHER|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
71682247|NCT04068688|142882881|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71865008|NCT00461981|143245224|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|16.2||||||95.0|-17.6|45.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||45.4|-17.6|
71865009|NCT00461981|143245225|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-18.2||||||95.0|-40.0|4.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.9|-40.0|
71865010|NCT00461981|143245226|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.6||||||95.0|-27.4|13.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||13.3|-27.4|
71865011|NCT00461981|143245227|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|35.7||||||95.0|9.5|57.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||57.1|9.5|
71922173|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-10.88|3.16|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||3.16|-10.88|
71682248|NCT04068688|142882881|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
71682249|NCT04068688|142882882|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||||||0.096
71682250|NCT04068688|142882882|OTHER|||||||0.732|||||||Wilcoxon (Mann-Whitney)|||||||0.732
71682251|NCT04068688|142882883|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71682252|NCT04068688|142882883|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||||||0.705
71865012|NCT00461981|143245228|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-5.0||||||95.0|-27.7|16.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||16.0|-27.7|
71865013|NCT00461981|143245229|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|14.7||||||95.0|-6.5|38.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||38.4|-6.5|
71865014|NCT00461981|143245230|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|38.1||||||95.0|0.9|65.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||65.9|0.9|
71865015|NCT00461981|143245231|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|11.7||||||95.0|-13.0|34.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||34.9|-13.0|
71865016|NCT00461981|143245232|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-15.8||||||95.0|-40.7|8.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||8.0|-40.7|
71865017|NCT00461981|143245233|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|0.43||||||95.0|0.24|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.24|
71865018|NCT00461981|143245234|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.2||||||95.0|0.09|0.48||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.48|0.09|
71865019|NCT00461981|143245235|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.36||||||95.0|1.54|7.13||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||7.13|1.54|
71865020|NCT00461981|143245236|SUPERIORITY_OR_OTHER_LEGACY||GMT ratio|3.26||||||95.0|1.44|7.19||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.19|1.44|
71865021|NCT00461981|143245237|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.06||||||95.0|0.56|1.96||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.96|0.56|
71682253|NCT04068688|142882884|OTHER|||||||0.442|||||||Wilcoxon (Mann-Whitney)|||||||0.442
71682254|NCT04068688|142882884|OTHER|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||||||0.458
71682255|NCT04068688|142882885|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71682256|NCT04068688|142882885|OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71682257|NCT04068688|142882889|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71910545|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|1.1||||0.7907|TWO_SIDED|95.0|0.68|1.69||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.69|0.68|0.7907
71910546|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.2742|TWO_SIDED|95.0|0.43|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.43|0.2742
71910547|NCT01392378|143341691|SUPERIORITY_OR_OTHER||GMT Ratio|0.7||||0.267|TWO_SIDED|95.0|0.42|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.42|0.2670
71910548|NCT01392378|143341692|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.813|TWO_SIDED|95.0|0.71|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.71|0.813
71910549|NCT01392378|143341692|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.845|TWO_SIDED|95.0|0.79|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.34|0.79|0.845
71910550|NCT01392378|143341692|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.461|TWO_SIDED|95.0|0.65|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.65|0.461
71910551|NCT01392378|143341692|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.545|TWO_SIDED|95.0|0.68|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.68|0.545
71910552|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.712|TWO_SIDED|95.0|0.79|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.79|0.712
71910553|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.97||||0.837|TWO_SIDED|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.84|0.837
71910554|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.357|TWO_SIDED|95.0|0.78|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.78|0.357
71910555|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.88||||0.19|TWO_SIDED|95.0|0.76|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.76|0.190
71910556|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.813|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.813
71910557|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.136|TWO_SIDED|95.0|0.73|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.96|0.73|0.136
71910558|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.85||||0.104|TWO_SIDED|95.0|0.74|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.74|0.104
71910559|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.73|||<|0.001|TWO_SIDED|95.0|0.64|0.85||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.85|0.64|<0.001
71682258|NCT04068688|142882890|OTHER|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||||||0.084
71682259|NCT04068688|142882891|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71682260|NCT04068688|142882891|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
71910560|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.712|TWO_SIDED|95.0|0.72|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.04|0.72|0.712
71910561|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.206|TWO_SIDED|95.0|0.7|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.01|0.70|0.206
71910562|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.78||||0.066|TWO_SIDED|95.0|0.65|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.93|0.65|0.066
71910563|NCT01392378|143341693|SUPERIORITY_OR_OTHER||GMC Ratio|0.81||||0.085|TWO_SIDED|95.0|0.67|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.67|0.085
71910564|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|0.9||||0.712|TWO_SIDED|95.0|0.77|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.77|0.712
71910565|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.206|TWO_SIDED|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.00|0.74|0.206
71910566|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|0.84||||0.104|TWO_SIDED|95.0|0.72|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.72|0.104
71910567|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|0.74||||0.001|TWO_SIDED|95.0|0.63|0.87||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.87|0.63|0.001
71910568|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|0.95||||0.813|TWO_SIDED|95.0|0.82|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.82|0.813
71910569|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.837|TWO_SIDED|95.0|0.9|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.19|0.90|0.837
71910570|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.534|TWO_SIDED|95.0|0.81|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.81|0.534
71910571|NCT01392378|143341694|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.87|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.87|0.961
71910572|NCT01392378|143341695|SUPERIORITY_OR_OTHER||GMC Ratio|1.03||||0.85|TWO_SIDED|95.0|0.75|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.42|0.75|0.850
71682261|NCT04068688|142882892|OTHER|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||||||0.011
71910573|NCT01392378|143341695|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.837|TWO_SIDED|95.0|0.77|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.44|0.77|0.837
71910574|NCT01392378|143341695|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.695|TWO_SIDED|95.0|0.69|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.69|0.695
71910575|NCT01392378|143341695|SUPERIORITY_OR_OTHER||GMC Ratio|0.82||||0.408|TWO_SIDED|95.0|0.6|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.60|0.408
71682262|NCT04068688|142882892|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71682263|NCT04068688|142882896|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71682264|NCT04068688|142882896|OTHER|||||||0.139|||||||Wilcoxon (Mann-Whitney)|||||||0.139
71682265|NCT04679051|142882901|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||Two-tailed paired t-tests were used to compare variables between time in bed conditions.||||0.36
71910576|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.813|TWO_SIDED|95.0|0.69|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.30|0.69|0.813
71910577|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.837|TWO_SIDED|95.0|0.68|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.25|0.68|0.837
71910578|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.695|TWO_SIDED|95.0|0.68|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.68|0.695
71910579|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.961|TWO_SIDED|95.0|0.71|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.36|0.71|0.961
71910580|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|1.18||||0.808|TWO_SIDED|95.0|0.85|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.65|0.85|0.808
71910581|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.837|TWO_SIDED|95.0|0.8|1.5||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.50|0.80|0.837
71910582|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.92||||0.695|TWO_SIDED|95.0|0.66|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.66|0.695
71910583|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.82||||0.408|TWO_SIDED|95.0|0.58|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.58|0.408
71910584|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|1.07||||0.813|TWO_SIDED|95.0|0.78|1.46||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.46|0.78|0.813
71910585|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.8||||0.343|TWO_SIDED|95.0|0.59|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.08|0.59|0.343
71910586|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|1.12||||0.695|TWO_SIDED|95.0|0.82|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.82|0.695
71910587|NCT01392378|143341696|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.925|TWO_SIDED|95.0|0.69|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.31|0.69|0.925
71910588|NCT01392378|143341697|SUPERIORITY_OR_OTHER||GMC Ratio|1.08||||0.91|TWO_SIDED|95.0|0.81|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.43|0.81|0.910
71910589|NCT01392378|143341697|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.79|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.79|0.850
71910590|NCT01392378|143341697|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.868|TWO_SIDED|95.0|0.7|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.70|0.868
71682266|NCT04679051|142882902|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Paired t-test comparing the two time in bed protocols.||||0.51
71682267|NCT04679051|142882903|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Paired t-test comparing peak forearm blood flow between sleep protocols.||||0.03
71865022|NCT00461981|143245238|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.58||||||95.0|0.31|1.12||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.12|0.31|
71910591|NCT01392378|143341697|SUPERIORITY_OR_OTHER||GMC Ratio|0.87||||0.914|TWO_SIDED|95.0|0.67|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.15|0.67|0.914
71910592|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|1.05||||0.91|TWO_SIDED|95.0|0.89|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.89|0.910
71682268|NCT04679051|142882904|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Paired t-test used to compare carotid-femoral pulse wave velocity (index of arterial stiffness) between sleep protocols.||||0.29
71865023|NCT00461981|143245239|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.4||||||95.0|1.48|3.97||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.97|1.48|
71865024|NCT00461981|143245240|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.48||||||95.0|0.27|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.87|0.27|
71865025|NCT00461981|143245241|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.45||||||95.0|0.8|2.66||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.66|0.80|
71865026|NCT00461981|143245242|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.75||||||95.0|0.88|3.39||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.39|0.88|
71865027|NCT00461981|143245243|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.49||||||95.0|0.8|2.69||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||2.69|0.80|
71865028|NCT00461981|143245244|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.62||||||95.0|0.33|1.16||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.16|0.33|
71865029|NCT00461981|143245245|SUPERIORITY_OR_OTHER_LEGACY||Rate differences|-45.9||||||95.0|-71.7|-11.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-11.6|-71.7|
71865030|NCT00461981|143245246|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-25.0||||||95.0|-57.2|4.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||4.8|-57.2|
71865031|NCT00461981|143245247|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|65.0||||||95.0|34.4|85.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||85.3|34.4|
71865032|NCT00461981|143245248|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-0.6||||||95.0|-30.4|30.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||30.3|-30.4|
71865033|NCT00461981|143245249|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-37.0||||||95.0|-57.8|-17.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||-17.5|-57.8|
71865034|NCT00461981|143245250|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-8.3||||||95.0|-38.5|14.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||14.5|-38.5|
71865035|NCT00461981|143245251|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|21.9||||||95.0|-6.7|48.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||48.1|-6.7|
71865036|NCT00461981|143245252|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-22.4||||||95.0|-54.4|12.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||12.2|-54.4|
71865037|NCT00461981|143245253|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|33.3||||||95.0|-81.1|90.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||90.6|-81.1|
71865038|NCT00461981|143245254|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|0.0||||||95.0|-97.5|84.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||84.2|-97.5|
71865039|NCT00461981|143245255|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-9.5||||||95.0|-65.2|58.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||58.8|-65.2|
71865040|NCT00461981|143245256|SUPERIORITY_OR_OTHER_LEGACY||Rate difference|-20.0||||||95.0|-71.6|33.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).||33.9|-71.6|
71865041|NCT00461981|143245257|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.23||||||95.0|0.15|0.35||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.35|0.15|
71865042|NCT00461981|143245258|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.11||||||95.0|0.05|0.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||0.22|0.05|
71865043|NCT00461981|143245259|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.85||||||95.0|2.51|9.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||9.22|2.51|
71865044|NCT00461981|143245260|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|3.31||||||95.0|1.46|7.54||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||7.54|1.46|
71865045|NCT00461981|143245261|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|1.35||||||95.0|0.58|3.04||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.04|0.58|
71865046|NCT00461981|143245262|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.44||||||95.0|0.16|1.07||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.07|0.16|
71865047|NCT00461981|143245263|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|2.46||||||95.0|1.26|5.06||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||5.06|1.26|
71865048|NCT00461981|143245264|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.89||||||95.0|0.7|1.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.00|0.70|
71682269|NCT04679051|142882905|SUPERIORITY||||||<|0.001||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on Manikin throughput scores.||||<0.001
71682270|NCT04679051|142882906|SUPERIORITY|||||||0.04||||||Null hypothesis is that there was no difference in the change of executive function following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on the number of correct answers during a Stroop color-word test.||||0.04
71682271|NCT04679051|142882907|SUPERIORITY|||||||0.02||||||Null hypothesis is that there was no difference in change of spatial ability following one day of aerobic exercise. The ANOVA test was performed with a significance level of 0.05 (two-sided).|ANOVA|||A two-way repeated measures ANOVA was used to evaluate the main effect of exercise (before vs. after exercise) on throughput scores from a Switching task.||||0.02
71682272|NCT00033657|142882915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED|95.0|||||Log Rank|||||||0.48
71682273|NCT02248974|142882918|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.01
71682274|NCT02248974|142882919|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.||||0.47
71682275|NCT02248974|142882920|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.12
71682276|NCT02248974|142882921|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.||||0.79
71682277|NCT02248974|142882922|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71682278|NCT02248974|142882923|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71682279|NCT02248974|142882924|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71682280|NCT02248974|142882925|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71682281|NCT02248974|142882926|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71682282|NCT02248974|142882927|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71682283|NCT02248974|142882928|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71682284|NCT02248974|142882930|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71682285|NCT02248974|142882931|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71682286|NCT02248974|142882935|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71682287|NCT02248974|142882936|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71682288|NCT02248974|142882937|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71682289|NCT02248974|142882938|SUPERIORITY|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||||||0.006
71682290|NCT02248974|142882939|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71682291|NCT02248974|142882940|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71682292|NCT02248974|142882942|SUPERIORITY|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||||||0.77
71682293|NCT02248974|142882943|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71682294|NCT02248974|142882944|SUPERIORITY|||||||0.12|||||||Fisher Exact|||||||0.12
71682295|NCT02248974|142882951|SUPERIORITY|||||||0.98|||||||Fisher Exact|||||||0.98
71682296|NCT02248974|142882952|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71682297|NCT02332239|142882953|SUPERIORITY||Mean Difference (Final Values)|-7.48|STANDARD_ERROR_OF_MEAN|4.11||0.07|TWO_SIDED||||||Mixed effects longitudinal regression||d=0.37|BDI Score where baseline \>=20: 8 week||||0.07
71682298|NCT02332239|142882954|SUPERIORITY||Median Difference (Final Values)|-7.29|STANDARD_ERROR_OF_MEAN|2.62||0.01|TWO_SIDED||||||quantile regression models|Controlled for baseline and gender|d=0.46|CTS Score where baseline \>=4: 8 week||||0.01
71682299|NCT02332239|142882957|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||||||0.33
71682300|NCT00396877|142882968|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|11.1||||0.434|TWO_SIDED|95.0|-19.2|33.6||The a-priori threshold for statistical significance was \< 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.|Log Rank|A two-sided log-rank test was used.|The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.|"Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.~The study was designed with 80% power and an overall type I error rate of 5%."||33.6|-19.2|0.4340
71682301|NCT02945254|142882971|SUPERIORITY|||||||0.011||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.011
71682302|NCT02945254|142882972|SUPERIORITY|||||||0.13||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.13
71682303|NCT03436199|142882974|SUPERIORITY||Risk Difference (RD)|0.064||||0.0811|TWO_SIDED|95.0|-0.008|0.136|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.136|-0.008|0.0811
71682304|NCT03436199|142882974|SUPERIORITY||Risk Difference (RD)|0.098||||0.0104|TWO_SIDED|95.0|0.023|0.174|||Farrington-Manning score test|The Miettinen-Nurminen method was used to obtain the 95% confidence intervals.||||0.174|0.023|0.0104
71682305|NCT03436199|142882975|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.048||0.0162|TWO_SIDED|95.0|0.02|0.21|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.21|0.02|0.0162
71682306|NCT03436199|142882975|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.05||0.0142|TWO_SIDED|95.0|0.02|0.22|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.22|0.02|0.0142
71682307|NCT03436199|142882976|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.538||0.1424|TWO_SIDED|95.0|-1.85|0.27|||Mixed Models Analysis|Mixed models analysis with repeated measures||||0.27|-1.85|0.1424
71682308|NCT03436199|142882976|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.56||0.9467|TWO_SIDED|95.0|-1.14|1.06|||Mixed Models Analysis|Mixed models analysis with repeated measures||||1.06|-1.14|0.9467
71682309|NCT03436199|142882977|SUPERIORITY||Mean Difference (Net)|4.143|STANDARD_ERROR_OF_MEAN|1.7389||0.0176|TWO_SIDED|95.0|0.726|7.56|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.560|0.726|0.0176
71682310|NCT03436199|142882977|SUPERIORITY||Mean Difference (Net)|3.529|STANDARD_ERROR_OF_MEAN|1.8196||0.053|TWO_SIDED|95.0|-0.046|7.104|||Mixed Models Analysis|Mixed models analysis with repeated measures||||7.104|-0.046|0.0530
71682311|NCT02631070|142882978|SUPERIORITY||Common Risk Difference on Response Rate|24.56|||<|0.0001|TWO_SIDED|95.0|14.48|34.64|||Cochran-Mantel-Haenszel|||||34.64|14.48|<0.0001
71682312|NCT02631070|142882978|SUPERIORITY||Odds Ratio (OR)|5.065|||<|0.0001|TWO_SIDED|95.0|2.278|11.259|||Cochran-Mantel-Haenszel|||||11.259|2.278|<0.0001
71682313|NCT02631070|142882979|SUPERIORITY||Common Risk Difference on Response Rate|20.0||||0.0002|TWO_SIDED|95.0|10.92|29.08|||Cochran-Mantel-Haenszel|||||29.08|10.92|0.0002
71682314|NCT02631070|142882979|SUPERIORITY||Odds Ratio (OR)|5.071||||0.0002|TWO_SIDED|95.0|2.002|12.844|||Cochran-Mantel-Haenszel|||||12.844|2.002|0.0002
71682315|NCT02631070|142882980|SUPERIORITY||Common Risk Difference on Response Rate|21.37||||0.0003|TWO_SIDED|95.0|11.23|31.51|||Cochran-Mantel-Haenszel|||||31.51|11.23|0.0003
71682316|NCT02631070|142882980|SUPERIORITY||Odds Ratio (OR)|4.045||||0.0003|TWO_SIDED|95.0|1.827|8.956|||Cochran-Mantel-Haenszel|||||8.956|1.827|0.0003
71682317|NCT02631070|142882981|SUPERIORITY||Common Risk Difference on Response Rate|29.55|||<|0.0001|TWO_SIDED|95.0|18.73|40.36|||Cochran-Mantel-Haenszel|||||40.36|18.73|<0.0001
71682318|NCT02631070|142882981|SUPERIORITY||Odds Ratio (OR)|5.306|||<|0.0001|TWO_SIDED|95.0|2.526|11.146|||Cochran-Mantel-Haenszel|||||11.146|2.526|<0.0001
71682319|NCT02631070|142882983|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||<0.0001
71682320|NCT02631070|142882983|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||<0.0001
71682321|NCT02631070|142882984|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 24||||<0.0001
71682322|NCT02631070|142882984|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 48||||<0.0001
71682323|NCT02631070|142882985|SUPERIORITY||Hazard Ratio (HR)|0.446||||0.0445|TWO_SIDED|95.0|0.196|1.013|||Log Rank||HR is from the Cox proportional hazards model|||1.013|0.196|0.0445
71682324|NCT02631070|142882986|SUPERIORITY||Hazard Ratio (HR)|0.784||||0.5121|TWO_SIDED|95.0|0.362|1.699|||Log Rank||HR is from the Cox proportional hazards model|||1.699|0.362|0.5121
71682325|NCT02631070|142882988|SUPERIORITY|||||||0.2382|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.2382
71682326|NCT02631070|142882988|SUPERIORITY|||||||0.5127|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.5127
71682327|NCT02631070|142882989|SUPERIORITY|||||||0.5479|||||||Cochran-Mantel-Haenszel|||Week 1 -24||||0.5479
71682328|NCT02631070|142882989|SUPERIORITY|||||||0.298|||||||Cochran-Mantel-Haenszel|||Week 1 - 48||||0.2980
71682329|NCT02631070|142882990|SUPERIORITY||LS Mean Difference|-229.1|STANDARD_ERROR_OF_MEAN|74.43||0.0024|TWO_SIDED|95.0|-375.8|-82.4|||ANCOVA|||Week 9 Through 24||-82.4|-375.8|0.0024
71682330|NCT02631070|142882990|SUPERIORITY||LS Mean Difference|-319.5|STANDARD_ERROR_OF_MEAN|144.57||0.0294|TWO_SIDED|95.0|-606.3|-32.7|||ANCOVA|||Week 33 Through 48||-32.7|-606.3|0.0294
71682331|NCT02631070|142882991|SUPERIORITY||LS Mean Difference|-41.0|STANDARD_ERROR_OF_MEAN|40.18||0.3087|TWO_SIDED|95.0|-120.3|38.2|||ANCOVA|||Weeks 9 Through 24||38.2|-120.3|0.3087
71682332|NCT02631070|142882991|SUPERIORITY||LS Mean Difference|-24.9|STANDARD_ERROR_OF_MEAN|93.42||0.7903|TWO_SIDED|95.0|-210.7|160.8|||ANCOVA|||Weeks 33 Through 48||160.8|-210.7|0.7903
71682333|NCT02631070|142882996|SUPERIORITY||Hazard Ratio (HR)|0.986||||0.958|TWO_SIDED|95.0|0.595|1.636|||Log Rank||HR is from the Cox proportional hazards model|||1.636|0.595|0.9580
71682334|NCT01153620|142883012|SUPERIORITY_OR_OTHER||||||=|0.006||95.0|||||Wilcoxon (Mann-Whitney)|||||||=0.006
71682335|NCT01886781|142883016|NON_INFERIORITY_OR_EQUIVALENCE|To determine an effect size of 0.64 with 80% power, a sample size of 27 for each group (D-IBS, C-IBS and controls), with a type 1 error of 5% using a two sided test was sufficient. Sample size based on expected behaviour of primary outcome measure. The minimally clinically important difference based on the primary outcome measure with the instrument used was 50 points.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) \& time as factors.||||<0.05
71682336|NCT01832818|142883056|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71682337|NCT01832818|142883057|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< 0.05
71922174|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-9.53|STANDARD_ERROR_OF_MEAN|3.16|||TWO_SIDED|95.0|-16.1|-2.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8||-2.95|-16.10|
71922175|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-5.66|STANDARD_ERROR_OF_MEAN|2.96|||TWO_SIDED|95.0|-11.82|0.5|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||0.50|-11.82|
71922176|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-8.62|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-17.77|0.54|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||0.54|-17.77|
71922177|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-6.05|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-14.79|2.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||2.69|-14.79|
71922178|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|4.4|||TWO_SIDED|95.0|-10.51|7.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.79|-10.51|
71682338|NCT01672294|142883069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5376|||<|0.511|TWO_SIDED|95.0|-1.0776|2.1528||Between Outlook Intervention and Attention Control caregivers at 5 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.1528|-1.0776|<0.511
71682339|NCT01672294|142883069|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4275||||0.6348|TWO_SIDED|95.0|-1.3505|2.2055||Between Outlook Intervention and Attention Control caregivers at 8 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.2055|-1.3505|0.6348
71865049|NCT00461981|143245265|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.51||||||95.0|0.23|1.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.22|0.23|
71865050|NCT00461981|143245266|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|4.0||||||95.0|4.0|4.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||4.00|4.00|
71865051|NCT00461981|143245267|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.8||||||95.0|0.22|3.63||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||3.63|0.22|
71865052|NCT00461981|143245268|SUPERIORITY_OR_OTHER_LEGACY||GMT Ratio|0.66||||||95.0|0.25|1.73||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.||1.73|0.25|
71865053|NCT00461981|143245273|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71865054|NCT00731133|143245314|SUPERIORITY_OR_OTHER||Slope|2.6466|STANDARD_ERROR_OF_MEAN|0.9016||0.05|TWO_SIDED|95.0|0.7858|4.5073|||Mixed Models Analysis|7,24||Open-label study testing for change in side-effects ratings over time (i.e., slope).||4.5073|.7858|0.05
71865055|NCT00731133|143245315|SUPERIORITY_OR_OTHER||Slope|-0.373|STANDARD_ERROR_OF_MEAN|0.2196||0.05|TWO_SIDED|95.0|-0.8075|0.0615|||Mixed Models Analysis|7,24||Open label study testing changes in amphetamine use over time (i.e., slope).||0.06150|-0.8075|0.05
71865056|NCT03098563|143245337|SUPERIORITY|||||||0.021|||||||ANOVA|||||||.021
71865057|NCT02964325|143245363|NON_INFERIORITY|An NI analysis was carried out to assess the primary efficacy endpoint with the null hypothesis being the MIRASOL group is inferior to the CONTROL group and the alternative hypothesis being the MIRASOL group is non-inferior to the CONTROL group. In this study, the NI margin was 1.6.|Relative Rate|2.79|||||TWO_SIDED|95.0|1.67|4.67|||||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative rate. For days during off-protocol intervals, bleeding data were simulated using an estimate of the individual-specific bleeding rate.|The MIRASOL and CONTROL groups were compared with respect to the number of days of WHO ≥ Grade 2 bleeding. This was carried out by fitting a negative binomial regression model with an offset defined as the natural logarithm (LN) of the number of days that bleeding was assessed in order to account for the fact that subjects had different numbers of bleeding assessment days.||4.67|1.67|
71682340|NCT01672294|142883070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6836||||0.5225|TWO_SIDED|95.0|-1.4278|2.795|||Mixed Models Analysis|||Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.7950|-1.4278|0.5225
71682341|NCT01672294|142883070|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2764||||0.1972|TWO_SIDED|95.0|-0.6728|3.2257|||Mixed Models Analysis|||Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||3.2257|-0.6728|0.1972
71865058|NCT02964325|143245365|NON_INFERIORITY|A non-inferiority margin of 1.2 was used to evaluated this endpoint.|Relative Risk|1.32||||0.7274|TWO_SIDED|95.0|0.97|1.81|||Wald Non-inferiority Test||The MIRASOL group represents the numerator and the CONTROL group represents the denominator for the relative risk.|The null hypothesis was H0: pt/pc \> 1.2 (ie, MIRASOL had more than a 20% higher probability of a patient experiencing at least one WHO ≥ Grade 2 bleed compared to CONTROL).||1.81|0.97|0.7274
71865059|NCT02964325|143245366|OTHER|||||||0.07|||||||Log-rank test|||||||0.07
71865060|NCT02964325|143245367|OTHER|||||||0.1649|||||||Fisher Exact|||||||0.1649
71865061|NCT02964325|143245368|OTHER||Risk Ratio (RR)|2.15||||0.0015|TWO_SIDED|95.0|1.32|3.49|||Fisher Exact|||||3.49|1.32|0.0015
71865062|NCT04145700|143245439|SUPERIORITY||Posterior Mean Hazard Ratio|2.62||||0.051|TWO_SIDED|80.0|1.19|4.46|||Bayesian hierarchical model|||To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 \[i.e., Pr(HR \< 1) \> 99%\]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.||4.46|1.19|0.051
71865063|NCT04978493|143245451|OTHER||Difference of adjusted means|1.92|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|95.0|-0.99|4.84|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||4.84|-0.99|
71865064|NCT04978493|143245452|OTHER||Difference of adjusted means|13.34|STANDARD_ERROR_OF_MEAN|11.32|||TWO_SIDED|95.0|-9.46|36.14|||||(Adjusted mean BI 706321 and ustekinumab) - (adjusted mean Placebo and ustekinumab)|The analysis was a restricted maximum likelihood (REML) based analysis of covariance (ANCOVA). For the ANCOVA model, absolute change in SES-CD score was the dependent variable, treatment group and baseline corticosteroid use (yes/no) were fixed effects and baseline SES-CD score was a continuous covariate.||36.14|-9.46|
71865065|NCT04978493|143245453|OTHER||Unadjusted risk difference|-27.5|||||TWO_SIDED|95.0|-48.42|-2.64|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||-2.64|-48.42|
71865066|NCT04978493|143245454|OTHER||Unadjusted risk difference|0.67|||||TWO_SIDED|95.0|-20.49|22.12|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||22.12|-20.49|
71865067|NCT04978493|143245455|OTHER||Unadjusted risk difference|-3.83|||||TWO_SIDED|95.0|-21.14|13.25|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||13.25|-21.14|
71865068|NCT04978493|143245456|OTHER||Unadjusted risk difference|0.33|||||TWO_SIDED|95.0|-17.67|18.78|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.78|-17.67|
71865069|NCT04978493|143245457|OTHER||Unadjusted risk difference|-3.33|||||TWO_SIDED|95.0|-24.91|18.85|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||18.85|-24.91|
71865070|NCT04978493|143245458|OTHER||Unadjusted risk difference|-3.5|||||TWO_SIDED|95.0|-23.86|17.34|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||17.34|-23.86|
71865071|NCT04978493|143245459|OTHER||Unadjusted risk difference|-18.5|||||TWO_SIDED|95.0|-42.32|8.89|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||8.89|-42.32|
71865072|NCT04978493|143245460|OTHER||Unadjusted risk difference|0.83|||||TWO_SIDED|95.0|-21.53|23.41|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||23.41|-21.53|
71865073|NCT04978493|143245461|OTHER||Unadjusted risk difference|-22.17|||||TWO_SIDED|95.0|-45.42|5.19|||||BI 706321 and ustekinumab - Placebo and ustekinumab|Unadjusted risk difference between treatment groups were calculated simply as the difference in the observed percentage of patients. The method to provide confidence intervals for the unadjusted risk differences was derived from the Newcombe method.||5.19|-45.42|
71865074|NCT00316017|143245480|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.||||0.91
71865075|NCT00316017|143245481|SUPERIORITY_OR_OTHER|||||||0.94||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.||||0.94
71865076|NCT00316017|143245482|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.73
71865077|NCT00316017|143245483|SUPERIORITY_OR_OTHER|||||||0.8||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.||||0.8
71682342|NCT01672294|142883071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9358|||<|0.3332|TWO_SIDED|95.0|-0.9726|2.8443|||Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||2.8443|-0.9726|<0.3332
71682343|NCT01672294|142883071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6929||||0.3842|TWO_SIDED|95.0|-0.8783|2.2642||Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks||2.2642|-0.8783|0.3842
71682344|NCT01672294|142883072|SUPERIORITY_OR_OTHER||expected change in difference in logs|0.0593||||0.8748|TWO_SIDED|95.0|-0.6784|0.797|||Standard negative binomial with offset||The expected change in the difference of the logs of expected Days in VA inpatient care or ED.|||0.797|-0.6784|0.8748
71682345|NCT01672294|142883073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01777||||0.7687|TWO_SIDED|95.0|-0.1372|0.1017||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 5 weeks|Mixed Models Analysis|||"Between Outlook Intervention caregivers and active control caregivers at 5 weeks.~Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks."||0.1017|-0.1372|0.7687
71682346|NCT01672294|142883073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.00087||||0.9863|TWO_SIDED|95.0|-0.1003|0.09861||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.||0.09861|-0.1003|0.9863
71682347|NCT01672294|142883074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01166||||0.9221|TWO_SIDED|95.0|-0.2475|0.2241|||Mixed Models Analysis|||At 5 weeks - Completion subscale||0.2241|-0.2475|0.9221
71682348|NCT01672294|142883074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1154||||0.3249|TWO_SIDED|95.0|-0.3466|0.1158||Between Caregiver Outlook - Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.||0.1158|-0.3466|0.3249
71682349|NCT01273155|142883080|OTHER|Belinostat|Kendall's Tau|0.096||||0.327|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.327
71682350|NCT01273155|142883080|OTHER|Belinostat glucuronide|Kendall's Tau|-0.178||||0.063|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.063
71682351|NCT01273155|142883080|OTHER|Methyl belinostat|Kendall's Tau|0.382|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71682352|NCT01273155|142883080|OTHER|M21|Kendall's Tau|0.253||||0.009|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.009
71865078|NCT00316017|143245484|SUPERIORITY_OR_OTHER|||||||0.69||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.69
71865079|NCT00316017|143245485|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.||||0.57
71865080|NCT00316017|143245486|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.66
71865081|NCT00316017|143245487|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.||||0.82
71865082|NCT00316017|143245488|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.||||0.98
71865083|NCT00316017|143245489|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.||||0.85
71865084|NCT00316017|143245490|SUPERIORITY_OR_OTHER|||||||0.48||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.||||0.48
71865085|NCT00316017|143245491|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.||||<0.01
71865086|NCT00316017|143245492|SUPERIORITY_OR_OTHER||||||<|0.02||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.||||<0.02
71910593|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|1.04||||0.85|TWO_SIDED|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.22|0.89|0.850
71682353|NCT01273155|142883080|OTHER|M24|Kendall's Tau|-0.278||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
71865087|NCT00316017|143245493|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.||||<0.01
71865088|NCT00316017|143245494|SUPERIORITY_OR_OTHER|||||||0.51||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.||||0.51
71865089|NCT00316017|143245495|SUPERIORITY_OR_OTHER|||||||0.73||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.||||0.73
71865090|NCT00316017|143245496|SUPERIORITY_OR_OTHER|||||||0.83||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.||||0.83
71865091|NCT00316017|143245497|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.||||0.31
71910594|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|1.0||||0.961|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.961
71682354|NCT01273155|142883080|OTHER|M26|Kendall's Tau|0.098||||0.312|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.312
71682355|NCT01273155|142883081|OTHER|Belinostat|Kendall's Tau|0.215||||0.025|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.025
71682356|NCT01273155|142883081|OTHER|Methyl belinostat|Kendall's Tau|0.426|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71682357|NCT01273155|142883081|OTHER|M21|Kendall's Tau|0.337|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71682358|NCT01273155|142883081|OTHER|M24|Kendall's Tau|-0.061||||0.524|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.524
71682359|NCT01273155|142883081|OTHER|M26|Kendall's Tau|0.246||||0.01|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.010
71682360|NCT01273155|142883082|OTHER||Kendall's Tau|0.057||||0.548|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.548
71682361|NCT01273155|142883083|OTHER|Belinostat|Kendall's Tau|0.091||||0.34|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.340
71682362|NCT01273155|142883083|OTHER|Belinostat glucuronide|Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
71910595|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.916|TWO_SIDED|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.16|0.85|0.916
71682363|NCT01273155|142883083|OTHER|Methyl belinostat|Kendall's Tau|0.268||||0.005|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.005
71682364|NCT01273155|142883083|OTHER|M21|Kendall's Tau|0.242||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
71682365|NCT01273155|142883083|OTHER|M24|Kendall's Tau|-0.114||||0.231|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.231
71682366|NCT01273155|142883083|OTHER|M26|Kendall's Tau|0.22||||0.021|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.021
71682367|NCT01273155|142883084|OTHER||Kendall's Tau|-0.216||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
71910596|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.99||||0.91|TWO_SIDED|95.0|0.87|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.87|0.910
71910597|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|1.01||||0.909|TWO_SIDED|95.0|0.89|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.89|0.909
71865092|NCT00316017|143245498|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.||||0.97
71910598|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|1.06||||0.868|TWO_SIDED|95.0|0.93|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.20|0.93|0.868
71910599|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.81|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.05|0.81|0.914
71865093|NCT00316017|143245500|SUPERIORITY_OR_OTHER|||||||0.35||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.||||0.35
71865094|NCT00316017|143245501|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.||||0.34
71865095|NCT04854850|143245533|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865096|NCT01123070|143245575|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.93||||0.4265|TWO_SIDED|90.0|0.797|1.084|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator and MabThera arm is the denominator|||1.084|0.797|0.4265
71865097|NCT01123070|143245576|EQUIVALENCE|Bioequivalence declared if the back transformed 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.862||||0.0368|TWO_SIDED|90.0|0.768|0.968|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|||0.968|0.768|0.0368
71865098|NCT01123070|143245578|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.909||||0.1484|TWO_SIDED|90.0|0.814|1.014|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax1||1.014|0.814|0.1484
71865099|NCT01123070|143245578|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.766||||0.0241|TWO_SIDED|90.0|0.633|0.927|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|Cmax2||0.927|0.633|0.0241
71865100|NCT01123070|143245579|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.969||||0.652|TWO_SIDED|90.0|0.863|1.088|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011 arm is the numerator, MabThera arm is the denominator|AUC1||1.088|0.863|0.6520
71865101|NCT01123070|143245579|EQUIVALENCE|Bioequivalence declared if the 90% CI of geometric mean ratio is within the predefined limits of 0.75 to 1.33|Geometric mean ratio|0.961||||0.7835|TWO_SIDED|90.0|0.757|1.222|||ANCOVA|PK parameters were calculated using a logarithmic transformation. Covariates included body weight at screening, gender and treatment.|TL011/MabThera|AUC2||1.222|0.757|0.7835
71865102|NCT01498887|143245615|SUPERIORITY_OR_OTHER|||||||0.3118|||||||Wilcoxon (Mann-Whitney)|||||||0.3118
71865103|NCT03079297|143245622|SUPERIORITY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.5||0.4128|TWO_SIDED|95.0|-3.56|7.56|||t-test, 2 sided|||||7.56|-3.56|0.4128
71865104|NCT03079297|143245623|SUPERIORITY|||||||0.4286|||||||Fisher Exact|||||||0.4286
71865105|NCT03079297|143245624|SUPERIORITY|||||||0.999|||||||Fisher Exact|||||||.999
71865106|NCT03079297|143245625|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
71865107|NCT03079297|143245625|SUPERIORITY|||||||0.9932||||||P-value for Adverse effect burden 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9932
71910600|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.91|TWO_SIDED|95.0|0.76|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.11|0.76|0.910
71910601|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.91||||0.85|TWO_SIDED|95.0|0.76|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.09|0.76|0.850
71910602|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.93||||0.868|TWO_SIDED|95.0|0.78|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.78|0.868
71682368|NCT01273155|142883085|OTHER||Kendall's Tau|0.06||||0.531|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.531
71682369|NCT01273155|142883086|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.224||||0.023|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.023
71682370|NCT01273155|142883086|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.295||||0.011|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.011
71682371|NCT01273155|142883086|OTHER|M21/belinostat|Kendall's Tau|0.335||||0.004|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.004
71865108|NCT03079297|143245625|SUPERIORITY|||||||0.2242||||||P-value for Adverse effect burden 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2242
71865109|NCT03079297|143245626|SUPERIORITY|||||||0.7282||||||P-value for General fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7282
71865110|NCT03079297|143245626|SUPERIORITY|||||||0.8781||||||P-value for General fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.8781
71910603|NCT01392378|143341698|SUPERIORITY_OR_OTHER||GMC Ratio|0.92||||0.914|TWO_SIDED|95.0|0.76|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.76|0.914
71910604|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.96||||0.91|TWO_SIDED|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.83|0.910
71910605|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.94||||0.85|TWO_SIDED|95.0|0.82|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.07|0.82|0.850
71910606|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.939|TWO_SIDED|95.0|0.86|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.12|0.86|0.939
71865111|NCT03079297|143245626|SUPERIORITY|||||||0.226||||||P-value for General fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.226
71682372|NCT01273155|142883086|OTHER|M24/belinostat|Kendall's Tau|-0.24||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
71682373|NCT01273155|142883086|OTHER|M26/belinostat|Kendall's Tau|0.127||||0.275|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.275
71865112|NCT03079297|143245626|SUPERIORITY|||||||0.2158||||||P-value for Mental fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2158
71865113|NCT03079297|143245626|SUPERIORITY|||||||0.0081||||||P-value for Mental fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0081
71865114|NCT03079297|143245626|SUPERIORITY|||||||0.6768||||||P-value for Mental fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6768
71865115|NCT03079297|143245626|SUPERIORITY|||||||0.0076||||||P-value for Physical fatigue 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0076
71865116|NCT03079297|143245626|SUPERIORITY|||||||0.0858||||||P-value for Physical fatigue 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0858
71865117|NCT03079297|143245626|SUPERIORITY|||||||0.2065||||||P-value for Physical fatigue 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2065
71865118|NCT03079297|143245626|SUPERIORITY|||||||0.9712||||||P-value for Reduced motivation 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9712
71865119|NCT03079297|143245626|SUPERIORITY|||||||0.7572||||||P-value for Reduced motivation 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7572
71865120|NCT03079297|143245626|SUPERIORITY|||||||0.0588||||||P-value for Reduced motivation 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0588
71865121|NCT03079297|143245626|SUPERIORITY|||||||0.1857||||||P-value for Reduced activity 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.1857
71910607|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.279|TWO_SIDED|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.98|0.75|0.279
71910608|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.86||||0.149|TWO_SIDED|95.0|0.76|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.97|0.76|0.149
71865122|NCT03079297|143245626|SUPERIORITY|||||||0.9225||||||P-value for Reduced activity 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.9225
71865123|NCT03079297|143245626|SUPERIORITY|||||||0.0414||||||P-value for Reduced activity 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0414
71865124|NCT03079297|143245627|SUPERIORITY|||||||0.4603||||||P-value for Psychosocial function 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.4603
71865125|NCT03079297|143245627|SUPERIORITY|||||||0.2521||||||P-value for Psychosocial function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.2521
71865126|NCT03079297|143245627|SUPERIORITY|||||||0.6635||||||P-value for Psychosocial function 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.6635
71865127|NCT03079297|143245628|SUPERIORITY|||||||0.7839||||||P-value for Anhedonia 3 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.7839
71865128|NCT03079297|143245628|SUPERIORITY|||||||0.0248||||||P-value for Anhedonia function 7 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0248
71865129|NCT03079297|143245628|SUPERIORITY|||||||0.0199||||||P-value for Anhedonia 14 days Change. Model: Change from baseline=Baseline, Visit, Treatment, Treatment\*Visit|MMRM|||||||0.0199
71910609|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|1.02||||0.85|TWO_SIDED|95.0|0.91|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.14|0.91|0.850
71922179|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-4.95|STANDARD_ERROR_OF_MEAN|4.11|||TWO_SIDED|95.0|-13.5|3.6|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.60|-13.50|
71865130|NCT02993406|143245631|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.004|TWO_SIDED|95.0|0.79|0.96|||Log Rank|||||0.96|0.79|0.004
71865131|NCT02993406|143245632|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0058|TWO_SIDED|95.0|0.76|0.96|||Log Rank|||||0.96|0.76|0.0058
71865132|NCT02993406|143245633|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0016|TWO_SIDED|95.0|0.66|0.91|||Log Rank|||||0.91|0.66|0.0016
71865133|NCT02993406|143245634|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.0013|TWO_SIDED|95.0|0.72|0.92|||Log Rank|||||0.92|0.72|0.0013
71865134|NCT02993406|143245635|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1593|TWO_SIDED|95.0|0.67|1.07|||Log Rank|||||1.07|0.67|0.1593
71865135|NCT02993406|143245636|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6227|TWO_SIDED|95.0|0.88|1.24|||Log Rank|||||1.24|0.88|0.6227
71865136|NCT02993406|143245637|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6608|TWO_SIDED|95.0|0.9|1.18|||Log Rank|||||1.18|0.90|0.6608
71865137|NCT05262517|143245654|OTHER||Least square (LS) mean difference|-0.15|||||TWO_SIDED|95.0|-1.78|1.48||||||LS means and CIs were estimated by an analysis of covariance (ANCOVA) model, using restricted maximum likelihood (REML) with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||1.48|-1.78|
71865138|NCT05262517|143245655|OTHER||LS mean difference|5.12|||||TWO_SIDED|95.0|-21.35|31.59||||||LS means and CIs were estimated by an analysis of covariance model using REML with baseline NRS value as a covariate and treatment group and stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms) as the main effects.||31.59|-21.35|
71865139|NCT05262517|143245656|OTHER||LS mean difference|0.21|||||TWO_SIDED|95.0|-0.99|1.41||||||LS means, and CIs were based on a generalized linear mixed effect model (GLMEM) that included the baseline value as a covariate and fixed effects for treatment group, stratification factor (use of daily medications/ oral devices to reduce the intensity of TMD symptoms; yes or no), scheduled time point, and time point by-treatment group interaction.||1.41|-0.99|
71865140|NCT05262517|143245657|OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-21.3|10.9||||||Stratified by use of daily medications/ oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenzsel weighting.||10.9|-21.3|
71865141|NCT05262517|143245660|OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.7|16.6||||||Stratified by use of daily medications/oral devices to reduce the intensity of TMD symptoms at randomization with Mantel-Haenszel weighting.||16.6|-8.7|
71865142|NCT04325282|143245661|OTHER|||||||0.04||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after active rTMS (post-rTMS compared to pre-rTMS).||||0.04
71865143|NCT04325282|143245661|OTHER|||||||0.46||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Within-group analysis of change after sham rTMS (post-rTMS compared to pre-rTMS).||||0.46
71865144|NCT04325282|143245661|OTHER|||||||0.12||||||The a priori threshold for statistical significance was \<0.05.|Wilcoxon signed rank test|||Between-group analysis of change induced by active rTMS versus sham rTMS||||0.12
71865145|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed-rank test|||Within-group analysis of change in cF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
71682374|NCT01273155|142883086|OTHER|M24/M26|Kendall's Tau|-0.308||||0.002|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.002
71682375|NCT01273155|142883086|OTHER|M26/M21|Kendall's Tau|-0.159||||0.095|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.095
71910610|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.89||||0.394|TWO_SIDED|95.0|0.79|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||0.99|0.79|0.394
71910611|NCT01392378|143341699|SUPERIORITY_OR_OTHER||GMC Ratio|0.98||||0.916|TWO_SIDED|95.0|0.87|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.10|0.87|0.916
71910612|NCT01392378|143341700|SUPERIORITY_OR_OTHER||GMC Ratio|1.26||||0.869|TWO_SIDED|95.0|0.9|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.76|0.90|0.869
71910613|NCT01392378|143341700|SUPERIORITY_OR_OTHER||GMC Ratio|1.07||||0.85|TWO_SIDED|95.0|0.78|1.48||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.48|0.78|0.850
71910614|NCT01392378|143341700|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.868|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.868
71910615|NCT01392378|143341700|SUPERIORITY_OR_OTHER||GMC Ratio|1.1||||0.916|TWO_SIDED|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.52|0.80|0.916
71910616|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.91|TWO_SIDED|95.0|0.78|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.24|0.78|0.910
71910617|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|1.05||||0.85|TWO_SIDED|95.0|0.83|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.32|0.83|0.850
71910618|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|1.09||||0.868|TWO_SIDED|95.0|0.87|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.37|0.87|0.868
71910619|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|1.02||||0.916|TWO_SIDED|95.0|0.81|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.28|0.81|0.916
71910620|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.99||||0.91|TWO_SIDED|95.0|0.79|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.79|0.910
71910621|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.94||||0.85|TWO_SIDED|95.0|0.76|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.76|0.850
71910622|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.95||||0.868|TWO_SIDED|95.0|0.77|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.17|0.77|0.868
71910623|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.916|TWO_SIDED|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.79|0.916
71922180|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-3.43|STANDARD_ERROR_OF_MEAN|3.55|||TWO_SIDED|95.0|-10.81|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.96|-10.81|
71682376|NCT01273155|142883087|OTHER|Belinostat glucuronide/belinostat|Kendall's Tau|-0.055||||0.568|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.568
71865146|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
71910624|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.97||||0.91|TWO_SIDED|95.0|0.77|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.77|0.910
71922181|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-5.38|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-12.64|1.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||1.89|-12.64|
71682377|NCT01273155|142883087|OTHER|Methyl belinostat/belinostat|Kendall's Tau|0.38|||<|0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||<0.001
71865147|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iT connectivity induced by active versus sham rTMS.||||<0.0001
71865148|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||<0.0001
71865149|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.43||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.43
71865150|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.|||||<|0.0001||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-iT connectivity induced by active versus sham rTMS.||||<0.0001
71865151|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
71865152|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.54||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.54
71865153|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.007||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cM connectivity induced by active versus sham rTMS.||||0.007
71865154|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.002||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.002
71865155|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.32||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.32
71865156|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iT connectivity induced by active versus sham rTMS.||||0.01
71682378|NCT01273155|142883087|OTHER|M21/belinostat|Kendall's Tau|0.315||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
71682379|NCT01273155|142883087|OTHER|M24/belinostat|Kendall's Tau|-0.205||||0.037|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.037
71682380|NCT01273155|142883087|OTHER|M26/belinostat|Kendall's Tau|0.218||||0.033|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.033
71682381|NCT01273155|142883087|OTHER|M24/M26|Kendall's Tau|-0.309||||0.001|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.001
71910625|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.84||||0.85|TWO_SIDED|95.0|0.67|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.06|0.67|0.850
71910626|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.98||||0.939|TWO_SIDED|95.0|0.78|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.23|0.78|0.939
71910627|NCT01392378|143341701|SUPERIORITY_OR_OTHER||GMT Ratio|0.96||||0.916|TWO_SIDED|95.0|0.76|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.||1.21|0.76|0.916
71910628|NCT02713789|143341722|SUPERIORITY|||||||0.827|||||||ANCOVA|||SEP2||||0.827
71910629|NCT02713789|143341722|SUPERIORITY|||||||0.594|||||||ANCOVA|||SEP2||||0.594
71910630|NCT02713789|143341722|SUPERIORITY|||||||0.274|||||||ANCOVA|||SEP3||||0.274
71910631|NCT02713789|143341722|SUPERIORITY|||||||0.766|||||||ANCOVA|||SEP3||||0.766
71910632|NCT02713789|143341723|SUPERIORITY|||||||0.384|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.384
71682382|NCT01273155|142883087|OTHER|M26/M21|Kendall's Tau|-0.205||||0.032|TWO_SIDED||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p\<0.05.||||0.032
71910633|NCT02713789|143341723|SUPERIORITY|||||||0.144|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.144
71910634|NCT02713789|143341723|SUPERIORITY|||||||0.022|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.022
71910635|NCT02713789|143341723|SUPERIORITY|||||||0.137|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.137
71910636|NCT02713789|143341723|SUPERIORITY|||||||0.123|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.123
71910637|NCT02713789|143341724|SUPERIORITY|||||||0.16|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.160
71910638|NCT02713789|143341724|SUPERIORITY|||||||0.208|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.208
71910639|NCT02713789|143341724|SUPERIORITY|||||||0.316|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.316
71910640|NCT02713789|143341724|SUPERIORITY|||||||0.221|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.221
71682383|NCT00336323|142883090|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 1.25 mg injection at baseline and at 6 weeks treatment group||||0.009
71682384|NCT00336323|142883090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 2.5mg injection at baseline and 6 weeks treatment group||||<0.001
71910641|NCT02713789|143341724|SUPERIORITY|||||||0.172|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.172
71910642|NCT02713789|143341725|SUPERIORITY|||||||0.199|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.199
71910643|NCT02713789|143341725|SUPERIORITY|||||||0.203|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.203
71910644|NCT02713789|143341725|SUPERIORITY|||||||0.5|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.500
71910645|NCT02713789|143341725|SUPERIORITY|||||||0.296|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.296
71910646|NCT02713789|143341725|SUPERIORITY|||||||0.286|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.286
71910647|NCT02713789|143341726|SUPERIORITY|||||||0.449|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.449
71910648|NCT02713789|143341726|SUPERIORITY|||||||0.381|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.381
71910649|NCT02713789|143341726|SUPERIORITY|||||||0.011|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.011
71682385|NCT00336323|142883090|SUPERIORITY_OR_OTHER|||||||0.66||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.66
71910650|NCT02713789|143341726|SUPERIORITY|||||||0.05|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.05
71910651|NCT02713789|143341726|SUPERIORITY|||||||0.09|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.09
71910652|NCT02713789|143341727|SUPERIORITY|||||||0.074|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.074
71910653|NCT02713789|143341727|SUPERIORITY|||||||0.468|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.468
71910654|NCT02713789|143341727|SUPERIORITY|||||||0.109|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level||||||0.109
71910655|NCT02713789|143341727|SUPERIORITY|||||||0.493|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.493
71910656|NCT02713789|143341727|SUPERIORITY|||||||0.235|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis||||||0.235
71910657|NCT02713789|143341728|SUPERIORITY|||||||0.136|||||||ANCOVA|||SEP1||||0.136
71910658|NCT02713789|143341728|SUPERIORITY|||||||0.498|||||||ANCOVA|||SEP1||||0.498
71910659|NCT02713789|143341728|SUPERIORITY|||||||0.369|||||||ANCOVA|||SEP4||||0.369
71910660|NCT02713789|143341728|SUPERIORITY|||||||0.337|||||||ANCOVA|||SEP4||||0.337
71682386|NCT00336323|142883090|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.49
71910661|NCT02713789|143341728|SUPERIORITY|||||||0.16|||||||ANCOVA|||SEP5||||0.160
71910662|NCT00014911|143341740|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|44.0|||||TWO_SIDED|95.0|30.0|61.0|||Fisher Exact|||||61|30|
71910663|NCT00014911|143341741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.0|||||TWO_SIDED|95.0|16.0|44.0|||Fisher Exact|||||44|16|
71910664|NCT00014911|143341742|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.0|||||TWO_SIDED|95.0|42.0|63.0|||Fisher Exact|||||63|42|
71910665|NCT03296787|143341775|SUPERIORITY|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.7265|||||||ANOVA|||||||0.7265
71910666|NCT03296787|143341775|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.9839|||||||ANOVA|||||||0.9839
71910667|NCT03296787|143341775|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.9393|||||||ANOVA|||||||0.9393
71910668|NCT03296787|143341775|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of Cmax (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.1321|||||||ANOVA|||||||0.1321
71910669|NCT03296787|143341776|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.36|||||||ANOVA|||||||0.3600
71910670|NCT03296787|143341776|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC(0-72) (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0816|||||||ANOVA|||||||0.0816
71910671|NCT03296787|143341776|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.2686|||||||ANOVA|||||||0.2686
71910672|NCT03296787|143341776|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC(0-72) (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0059|||||||ANOVA|||||||0.0059
71910673|NCT03296787|143341777|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0998|||||||ANOVA|||||||0.0998
71910674|NCT03296787|143341777|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0155|||||||ANOVA|||||||0.0155
71910675|NCT03296787|143341777|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0916|||||||ANOVA|||||||0.0916
71910676|NCT03296787|143341777|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUClast (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0014|||||||ANOVA|||||||0.0014
71910677|NCT03296787|143341778|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0038|||||||ANOVA|||||||0.0038
71910678|NCT03296787|143341778|SUPERIORITY|TAK-954 (Total): An ANOVA were performed on log transformed AUC∞ (total TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0004|||||||ANOVA|||||||0.0004
71910679|NCT03296787|143341778|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare moderate renal impairment group with the normal renal function group.||||||0.0389|||||||ANOVA|||||||0.0389
71910680|NCT03296787|143341778|SUPERIORITY|TAK-954 (Free): An ANOVA were performed on natural logarithm of AUC∞ (free TAK-954) to compare severe renal impairment group with the normal renal function group.||||||0.0011|||||||ANOVA|||||||0.0011
71910681|NCT01626989|143341790|NON_INFERIORITY_OR_EQUIVALENCE|Friedman Test comparing all 3 nights||||||0.001|||||||nonparametric Wilcoxon Signed Rank test|||||||.001
71910682|NCT02437487|143341804|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
71910683|NCT02437487|143341806|SUPERIORITY||Relative Risk|1.2624|||||TWO_SIDED|95.0|0.7668|2.0785||||||||2.0785|0.7668|
71910684|NCT02437487|143341807|SUPERIORITY||Relative Risk|1.2217|||||TWO_SIDED|95.0|0.7919|1.8849||||||||1.8849|0.7919|
71910685|NCT02437487|143341808|SUPERIORITY||Relative Risk|1.0878|||||TWO_SIDED|95.0|0.7383|1.6029||||||||1.6029|0.7383|
71910686|NCT01379924|143341809|SUPERIORITY||Odds Ratio (OR)|0.25||||0.037|TWO_SIDED|95.0|0.07|0.92|||Regression, Logistic|Adjusted for group differences at baseline and variables associated with differential study retention.|Usual care arm is reference group|Multiple logistic regression modeling used to compute adjusted odds ratios for 12-month follow-up data.||.92|.07|.037
71910687|NCT01379924|143341810|SUPERIORITY||Odds Ratio (OR)|0.24||||0.029|TWO_SIDED|95.0|0.07|0.86|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is reference group.|||.86|.07|.029
71910688|NCT01379924|143341811|SUPERIORITY||Odds Ratio (OR)|0.2||||0.017|TWO_SIDED|95.0|0.06|0.75|||Regression, Logistic|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.|Usual care arm is the reference group|||.75|.06|.017
71910689|NCT01379924|143341812|SUPERIORITY||Group by time interaction term coefficie|4.75|STANDARD_ERROR_OF_MEAN|3.84||0.217|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.217
71910690|NCT01379924|143341813|SUPERIORITY||Group by time interaction term coefficie|2.89|STANDARD_ERROR_OF_MEAN|3.77||0.444|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.444
71910691|NCT01379924|143341814|SUPERIORITY||Group by time interaction term coefficie|9.76|STANDARD_ERROR_OF_MEAN|3.82||0.011|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.011
71910692|NCT01379924|143341816|SUPERIORITY||Group by time interaction term coefficie|0.64|STANDARD_ERROR_OF_MEAN|0.59||0.758|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.758
71910693|NCT01379924|143341817|SUPERIORITY||Group by time interaction term coefficie|1.36|STANDARD_ERROR_OF_MEAN|0.6||0.024|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.024
71910694|NCT01379924|143341818|SUPERIORITY||Group by time interaction term coefficie|2.67|STANDARD_ERROR_OF_MEAN|2.88||0.354|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up||||||.354
71910695|NCT01379924|143341819|SUPERIORITY||Group by time interaction term coefficie|4.43|STANDARD_ERROR_OF_MEAN|2.85||0.121|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.121
71910696|NCT01379924|143341820|SUPERIORITY||Group by time interaction term coefficie|3.67|STANDARD_ERROR_OF_MEAN|2.89||0.205|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.205
71910697|NCT01379924|143341821|SUPERIORITY||Group by time interaction term coefficie|0.65|STANDARD_ERROR_OF_MEAN|2.6||0.803|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.803
71910698|NCT01379924|143341822|SUPERIORITY||Group by time interaction term coefficie|2.41|STANDARD_ERROR_OF_MEAN|2.56||0.347|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.347
71910699|NCT01379924|143341823|SUPERIORITY||Group by time interaction term coefficie|-1.39|STANDARD_ERROR_OF_MEAN|2.59||0.591|TWO_SIDED||||||Mixed Models Analysis|Adjusted for any variables that differed between groups at baseline, and variables associated with likelihood of study retention at follow-up.||||||.591
71682387|NCT00336323|142883090|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.45
71682388|NCT00336323|142883090|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.90
71865157|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
71865158|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.29||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cF connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.29
71910700|NCT01230749|143341828|SUPERIORITY_OR_OTHER||Difference in LSM|-27.4||||0.006|TWO_SIDED|95.0|-46.792|-8.008|||ANCOVA|||||-8.008|-46.792|0.006
71910701|NCT01230749|143341828|SUPERIORITY_OR_OTHER||Difference in LSM|-20.47||||0.038|TWO_SIDED|95.0|-39.801|-1.142|||ANCOVA|||||-1.142|-39.801|0.038
71910702|NCT01230749|143341828|SUPERIORITY_OR_OTHER||Difference in LSM|-13.24||||0.178|TWO_SIDED|95.0|-32.635|6.151|||ANCOVA|||||6.151|-32.635|0.178
71910703|NCT01230749|143341829|SUPERIORITY_OR_OTHER||Difference in LSM|-28.28||||0.005|TWO_SIDED|95.0|-47.606|-8.957|||ANCOVA|||||-8.957|-47.606|0.005
71910704|NCT01230749|143341829|SUPERIORITY_OR_OTHER||Difference in LSM|-21.97||||0.025|TWO_SIDED|95.0|-41.154|-2.786|||ANCOVA|||||-2.786|-41.154|0.025
71910705|NCT01230749|143341829|SUPERIORITY_OR_OTHER||Difference in LSM|-17.71||||0.069|TWO_SIDED|95.0|-36.86|1.431|||ANCOVA|||||1.431|-36.860|0.069
71910706|NCT01230749|143341830|SUPERIORITY_OR_OTHER||Difference in LSM|2.76||||0.628|TWO_SIDED|95.0|-8.542|14.054|||ANCOVA|||||14.054|-8.542|0.628
71910707|NCT01230749|143341830|SUPERIORITY_OR_OTHER||Difference in LSM|13.7||||0.018|TWO_SIDED|95.0|2.392|25.008|||ANCOVA|||||25.008|2.392|0.018
71682389|NCT00336323|142883091|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit||||0.42
71910708|NCT01230749|143341830|SUPERIORITY_OR_OTHER||Difference in LSM|5.87||||0.303|TWO_SIDED|95.0|-5.417|17.148|||ANCOVA|||||17.148|-5.417|0.303
71865159|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cF connectivity induced by active versus sham rTMS.||||0.02
71910709|NCT01230749|143341831|SUPERIORITY_OR_OTHER||Difference in LSM|-1.86||||0.041|TWO_SIDED|95.0|-3.634|-0.082|||ANCOVA|||||-0.082|-3.634|0.041
71910710|NCT01230749|143341831|SUPERIORITY_OR_OTHER||Difference in LSM|-0.26||||0.769|TWO_SIDED|95.0|-2.033|1.509|||ANCOVA|||||1.509|-2.033|0.769
71682390|NCT00336323|142883091|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit||||0.67
71910711|NCT01230749|143341831|SUPERIORITY_OR_OTHER||Difference in LSM|-0.69||||0.444|TWO_SIDED|95.0|-2.463|1.091|||ANCOVA|||||1.091|-2.463|0.444
71910712|NCT01230749|143341832|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|95.1||||0.774|TWO_SIDED|90.0|71.031|127.324|||ANCOVA|||||127.324|71.031|0.774
71910713|NCT01230749|143341832|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|89.9||||0.555|TWO_SIDED|90.0|66.567|121.403|||ANCOVA|||||121.403|66.567|0.555
71910714|NCT01230749|143341833|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|100.17||||0.968|TWO_SIDED|90.0|93.217|107.647|||ANCOVA|||||107.647|93.217|0.968
71910715|NCT01230749|143341833|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|101.18||||0.785|TWO_SIDED|90.0|94.179|108.7|||ANCOVA|||||108.700|94.179|0.785
71910716|NCT01230749|143341834|SUPERIORITY_OR_OTHER||GMR multiplied by 100 percent|133.27||||0.097|TWO_SIDED|90.0|100.275|177.115|||ANCOVA|||||177.115|100.275|0.097
71910717|NCT01230749|143341834|SUPERIORITY_OR_OTHER||GMR mulitplied by 100 percent|101.82||||0.917|TWO_SIDED|90.0|76.26|135.942|||ANCOVA|||||135.942|76.260|0.917
71910718|NCT01230749|143341835|SUPERIORITY_OR_OTHER||Difference in LSM|0.46||||0.295|TWO_SIDED|95.0|-0.408|1.323|||ANCOVA|||||1.323|-0.408|0.295
71910719|NCT01230749|143341835|SUPERIORITY_OR_OTHER||Difference in LSM|0.03||||0.941|TWO_SIDED|95.0|-0.838|0.904|||ANCOVA|||||0.904|-0.838|0.941
71910720|NCT01230749|143341835|SUPERIORITY_OR_OTHER||Difference in LSM|1.02||||0.022|TWO_SIDED|95.0|0.15|1.892|||ANCOVA|||||1.892|0.150|0.022
71910721|NCT00713284|143341867|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71910722|NCT03127852|143341868|SUPERIORITY|||||||0.48|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 physical component summary score.||||.48
71910723|NCT03127852|143341868|SUPERIORITY|||||||0.73|||||||t-test, 2 sided|||Poststudy between-group comparison of SF-36 mental component summary score.||||.73
71910724|NCT03127852|143341869|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of hospital visits.||||.02
71910725|NCT03127852|143341869|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported emergency department visits.||||.12
71910726|NCT03127852|143341869|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of clinic visits.||||.39
71910727|NCT03127852|143341869|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Poststudy between-group comparison of self-reported number of family physician visits.||||.28
71910728|NCT03127852|143341870|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI maintenance sub-scale.||||.74
71910729|NCT03127852|143341870|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI management sub-scale.||||.67
71910730|NCT03127852|143341870|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Poststudy between-group comparison of SCHFI confidence sub-scale.||||.92
71910731|NCT03127852|143341871|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ total score.||||.67
71910732|NCT03127852|143341871|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ physical domain score.||||.43
71910733|NCT03127852|143341871|SUPERIORITY|||||||0.64|||||||t-test, 2 sided|||Poststudy between-group comparison of MLHFQ emotional domain score.||||.64
71910734|NCT03127852|143341872|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS anxiety sub-scale.||||.06
71910735|NCT03127852|143341872|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||Poststudy between-group comparison of HADS depression sub-scale.||||.77
71910736|NCT03127852|143341873|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Poststudy between-group comparison of SEMCD6.||||.13
71910737|NCT01432457|143341892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.57||||0.006|TWO_SIDED|95.0|0.44|2.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.69|0.44|0.006
71910738|NCT01432457|143341892|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.96|||<|0.001|TWO_SIDED|95.0|0.84|3.08||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||3.08|0.84|< 0.001
71910739|NCT01432457|143341893|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.36||||0.014|TWO_SIDED|95.0|0.28|2.45|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.45|0.28|0.014
71910740|NCT01432457|143341893|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.67||||0.002|TWO_SIDED|95.0|0.59|2.74|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.74|0.59|0.002
71910741|NCT01432457|143341894|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||0.029
71910742|NCT01432457|143341894|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||||< 0.001
71910743|NCT01432457|143341895|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2||||0.009|TWO_SIDED|95.0|0.05|0.34|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|0.05|0.009
71910744|NCT01432457|143341895|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.28|||<|0.001|TWO_SIDED|95.0|0.13|0.43|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.43|0.13|< 0.001
71910745|NCT01432457|143341896|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17||||0.062|TWO_SIDED|95.0|-0.01|0.34|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.34|-0.01|0.062
71910746|NCT01432457|143341896|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.22||||0.014|TWO_SIDED|95.0|0.04|0.39|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.39|0.04|0.014
71910747|NCT01432457|143341897|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.242||||0.198|TWO_SIDED|95.0|0.893|1.726|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.726|0.893|0.198
71910748|NCT01432457|143341897|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.378||||0.054|TWO_SIDED|95.0|0.995|1.91|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.910|0.995|0.054
71682391|NCT00336323|142883091|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit||||0.48
71682392|NCT00336323|142883091|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Least squares regression|||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit||||0.82
71682393|NCT00336323|142883091|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 1.25mg injection at baseline and at 6 weeks treatment group||||0.01
71682394|NCT00336323|142883091|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 2.5mg injection at baseline and at 6 weeks treatment group||||0.003
71865160|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.003||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.003
71865161|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.66||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.66
71865162|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.008||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cT connectivity induced by active versus sham rTMS.||||0.008
71682395|NCT00336323|142883094|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to those that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||<0.0001
71682396|NCT00336323|142883095|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Least squares regression|Adjusted for baseline score||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline visual acuity letter score that was \<65 letters compared to those that had baseline visual acuity letter score that was ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.31
71865163|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.005||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.005
71865164|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.87||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.87
71865165|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.11||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-cT connectivity induced by active versus sham rTMS.||||0.11
71922182|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-0.08|STANDARD_ERROR_OF_MEAN|3.59|||TWO_SIDED|95.0|-7.55|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||7.39|-7.55|
71922183|NCT03091920|143365000|OTHER|No statistical testing was performed.|Least squares mean difference|-1.89|STANDARD_ERROR_OF_MEAN|3.37|||TWO_SIDED|95.0|-8.89|5.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||5.12|-8.89|
71922184|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.17|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.59|-4.17|
71682397|NCT00336323|142883096|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between those that were ≤66 years old compared to those that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.44
71682398|NCT00336323|142883097|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.55
71682399|NCT00336323|142883098|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had no history of treatment for diabetic macular edema compared to those that had history or treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.16
71682400|NCT00336323|142883099|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline retinopathy severity that was \<severe nonproliferative diabetic retinopathy (NPDR) compared to those that had baseline retinopathy severity that was proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.53
71682401|NCT00336323|142883100|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline clinical diabetic macular edema characterized as typical/predominantly focal, neither predominantly focal or diffuse, or typical/predominantly diffuse. Eyes included all of those from the pooled Bevacizumab group.||||0.93
71682402|NCT00336323|142883101|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline subretinal fluid that was definite/questionable compared to eyes that had no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.52
71682403|NCT00336323|142883102|SUPERIORITY_OR_OTHER|||||||0.22||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had baseline central subfield thickness of \<400 microns compared to eyes that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.||||0.22
71682404|NCT00336323|142883103|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline visual acuity letter score of \<65 letters compared to eyes that had baseline visual acuity letter score of ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.||||0.006
71865166|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.012||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.012
71865167|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.46||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.46
71865168|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.02||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iF-iM connectivity induced by active versus sham rTMS.||||0.02
71865169|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
71865170|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.99||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iT-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.99
71865171|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iT-cT connectivity induced by active versus sham rTMS.||||0.04
71682405|NCT00336323|142883104|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that were ≤66 years old at baseline compared to eyes that were \>66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.23
71682406|NCT00336323|142883105|SUPERIORITY_OR_OTHER|||||||0.37||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.||||0.37
71682407|NCT00336323|142883106|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that did not have a prior history of treatment for diabetic macular edema compared to eyes that did have a prior history of treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.||||0.04
71682408|NCT00336323|142883107|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline retinopathy severity of \<severe nonproliferative diabetic retinopathy (NPDR) compared to eyes that had baseline retinopathy severity of proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.||||0.38
71682409|NCT00336323|142883108|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline clinical diabetic macular edema (DME) characterization of typical/predominantly focal compared to neither predominantly focal or diffuse characterization at baseline and compared to typical/predominantly diffuse characterization at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.45
71682410|NCT00336323|142883109|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline subretinal fluid presence that was definite/questionable compared to eyes that there was no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.||||0.06
71682411|NCT01438814|142883122|NON_INFERIORITY_OR_EQUIVALENCE|One-sided test relative to 0.35|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|<0.0001
71682412|NCT01438814|142883122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.06||0.8924||95.0|-0.13|0.12|||ANCOVA|||||0.12|-0.13|0.8924
71910749|NCT01432457|143341898|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.105||||0.615|TWO_SIDED|95.0|0.749|1.631|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||1.631|0.749|0.615
71910750|NCT01432457|143341898|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.412||||0.072|TWO_SIDED|95.0|0.969|2.057|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||2.057|0.969|0.072
71910751|NCT01432457|143341899|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.09||||0.837|TWO_SIDED|95.0|-0.98|0.8||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.80|-0.98|0.837
71910752|NCT01432457|143341899|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.32||||0.471|TWO_SIDED|95.0|-1.19|0.55||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).||0.55|-1.19|0.471
71910753|NCT02574481|143341915|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
71910754|NCT02574481|143341916|NON_INFERIORITY|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions..|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is \<0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning|||||||<0.0001
71910755|NCT04134728|143341929|SUPERIORITY||Odds Ratio (OR)|1.38||||0.2868|TWO_SIDED|0.95|0.76|2.48|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12||2.48|0.76|0.2868
71910756|NCT04134728|143341929|SUPERIORITY||Odds Ratio (OR)|1.75||||0.0596|TWO_SIDED|0.95|0.98|3.15|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and placebo in the percentage of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from placebo in the percentage of participants with ACR20 response at Week 12||3.15|0.98|0.0596
71910757|NCT04134728|143341929|SUPERIORITY||Odds Ratio (OR)|2.34||||0.0049|TWO_SIDED|0.95|1.29|4.23|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 200 mg dose of Sarilumab alternating with placebo every week and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 200 mg dose of Sarilumab alternating with placebo every week differs from placebo in the proportion of participants with ACR20 response at Week 12||4.23|1.29|0.0049
71910758|NCT04134728|143341929|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0293|TWO_SIDED|0.95|0.36|0.95|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||0.95|0.36|0.0293
71682413|NCT01438814|142883123|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8201||95.0|0.672|1.37|||Regression, Logistic|Model includes treatment and continuous baseline HbA1c||||1.370|0.672|0.8201
71682414|NCT01438814|142883124|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.022||||0.9397|TWO_SIDED|95.0|0.582|1.796|||Regression, Logistic|Model includes treatment and baseline HbA1c.||||1.796|0.582|0.9397
71910759|NCT04134728|143341929|SUPERIORITY||Odds Ratio (OR)|0.75||||0.2308|TWO_SIDED|0.95|0.47|1.2|||Regression, Logistic|OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category.||The null hypothesis is that there is no difference between 150 mg dose of GSK3196165 and 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 150 mg dose of GSK3196165 differs from 200 mg dose of sarilumab alternating with placebo every week in the proportion of participants with ACR20 response at Week 12||1.20|0.47|0.2308
71910760|NCT03404219|143342022|OTHER|Single group pre-post, follow-up|Mean Difference (Final Values)|2.56||||0.09|TWO_SIDED||||||General Linear Model (repeated measures)|||Single arm||||0.09
71910761|NCT02038790|143342025|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||>0.5000
71910762|NCT02038790|143342026|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0196
71910763|NCT02038790|143342027|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.0006
71910764|NCT02038790|143342028|SUPERIORITY_OR_OTHER|||||||0.4422|TWO_SIDED|||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared|||||||0.4422
71910765|NCT02038790|143342029|SUPERIORITY_OR_OTHER|||||||0.2377|TWO_SIDED||||||Chi-squared|||||||0.2377
71910766|NCT02038790|143342030|SUPERIORITY_OR_OTHER|||||||0.0603|TWO_SIDED||||||Chi-squared|||||||0.0603
71910767|NCT02038790|143342031|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.0010
71910768|NCT00438464|143342079|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71910769|NCT00438464|143342080|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
71910770|NCT00438464|143342081|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71910771|NCT00438464|143342082|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.805
71910772|NCT00438464|143342083|SUPERIORITY_OR_OTHER|||||||0.254|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.254
71910773|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.7|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within GG3||||0.70
71910774|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG3||||0.38
71910775|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG3||||0.41
71910776|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG3||||0.75
71910777|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3||||0.57
71910778|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3||||0.12
71910779|NCT00438464|143342084|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Cleaved Caspase 3 (Caspase), Within GG3||||0.03
71682415|NCT01438814|142883125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|2.1||0.3352||95.0|-2.1|6.1|||ANCOVA|||||6.1|-2.1|0.3352
71682416|NCT01438814|142883126|SUPERIORITY_OR_OTHER|||||||0.0308|||||||Fisher Exact|Fishers exact p-value presented due to small cell counts||||||0.0308
71682417|NCT01438814|142883127|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0545||95.0|0.0|1.0|||ANCOVA|||||1.0|-0.0|0.0545
71682418|NCT01438814|142883128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.997||||0.9886||95.0|0.689|1.445|||Regression, Logistic|||||1.445|0.689|0.9886
71682419|NCT01438814|142883129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.797||||0.2108||95.0|0.558|1.137|||Regression, Logistic|||||1.137|0.558|0.2108
71910780|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Vascular Epithelial Growth Factor (VEGF3), Within GG4||||0.45
71910781|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG4||||0.83
71910782|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG4||||0.04
71910783|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG4||||0.80
71910784|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4||||0.61
71910785|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within GG4||||0.86
71910786|NCT00438464|143342085|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within GG4||||0.02
71910787|NCT00438464|143342090|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Finasteride Arm||||0.84
71910788|NCT00438464|143342090|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Finasteride Arm||||0.36
71910789|NCT00438464|143342090|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Finasteride||||0.09
71910790|NCT00438464|143342090|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Finasteride Arm||||0.46
71910791|NCT00438464|143342090|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Finasteride Arm||||0.88
71910792|NCT00438464|143342090|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Finasteride Arm||||0.18
71910793|NCT00438464|143342090|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Finasteride Arm||||<0.001
71910794|NCT00438464|143342091|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Placebo Arm||||0.32
71865172|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.01||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.01
71865173|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.31||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.31
71865174|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cT connectivity induced by active versus sham rTMS.||||0.05
71865175|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.03|||||||Wilcoxon signed rank test|The threshold for statistical significance was p \< 0.0076.||Within-group analysis of change in cF-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.03
71865176|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.2||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.20
71865177|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-cM connectivity induced by active versus sham rTMS.||||0.04
71910795|NCT00438464|143342091|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Placebo Arm||||0.83
71865178|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.05||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.05
71865179|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.59||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cF-iM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.59
71865180|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cF-iM connectivity induced by active versus sham rTMS.||||0.12
71682420|NCT01438814|142883130|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.9972||95.0|0.712|1.402|||Regression, Logistic|||||1.402|0.712|0.9972
71865181|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.1||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.10
71910796|NCT00438464|143342091|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||AR, Within Placebo Arm||||0.77
71910797|NCT00438464|143342091|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Placebo Arm||||0.87
71910798|NCT00438464|143342091|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Placebo Arm||||0.91
71910799|NCT00438464|143342091|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Placebo Arm||||0.90
71910800|NCT00438464|143342091|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Placebo Arm||||<0.001
71910801|NCT03943446|143342096|SUPERIORITY||Estimated Difference in ER Rate|-0.1|||=|0.59|TWO_SIDED|95.0|-0.44|0.23|||Fisher Exact|||||0.23|-0.44|=0.590
71910802|NCT03943446|143342096|SUPERIORITY||Estimated difference in ERR|-0.01|||=|1|TWO_SIDED|95.0|-0.34|0.31|||Fisher Exact|||||0.31|-0.34|=1.000
71910803|NCT01090102|143342137|SUPERIORITY_OR_OTHER|||||||0.63||||||Significant at p\<0.05|t-test, 2 sided|||||||0.63
71910804|NCT01090102|143342138|SUPERIORITY_OR_OTHER|||||||0.77||||||significant at p\<0.05|t-test, 2 sided|||||||0.77
71682421|NCT01438814|142883131|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.832||||0.2816||95.0|0.594|1.163|||Regression, Logistic|||||1.163|0.594|0.2816
71682422|NCT01438814|142883132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.19||0.0011||95.0|0.25|0.98|||ANCOVA|||||0.98|0.25|0.0011
71682423|NCT01438814|142883133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.7682||95.0|0.681|1.328|||Regression, Logistic|||||1.328|0.681|0.7682
71682424|NCT00337779|142883151|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0732|STANDARD_ERROR_OF_MEAN|0.1013||0.4859|TWO_SIDED|95.0|0.8799|1.309|||Regression, Poisson||980 subjects randomized into two arms provide approximately 90% power to detect significant difference between groups of 30% or more in rate of confirmed relapses.|||1.3090|0.8799|0.4859
71682425|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.12|||||TWO_SIDED|95.0|1.0|1.24||||||||1.24|1|
71682426|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.05|||||TWO_SIDED|95.0|0.95|1.17||||||||1.17|0.95|
71865182|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.57||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-iT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.57
71682427|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|0.94|||||TWO_SIDED|95.0|0.85|1.05||||||||1.05|0.85|
71682428|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|1.01|||||TWO_SIDED|95.0|0.92|1.11||||||||1.11|0.92|
71682429|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.99|||||TWO_SIDED|95.0|0.9|1.08||||||||1.08|0.9|
71922185|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-1.09|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|95.0|-4.47|2.29|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||2.29|-4.47|
71922186|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|95.0|-4.02|2.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||2.14|-4.02|
71922187|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-2.67|STANDARD_ERROR_OF_MEAN|1.89|||TWO_SIDED|95.0|-6.6|1.26|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||1.26|-6.60|
71922188|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-5.77|2.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.10|-5.77|
71682430|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.98|||||TWO_SIDED|95.0|0.89|1.07||||||||1.07|0.89|
71682431|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|1.0|||||TWO_SIDED|95.0|0.91|1.1||||||||1.1|0.91|
71682432|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
71682433|NCT01162122|142883154|NON_INFERIORITY_OR_EQUIVALENCE|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||TWO_SIDED|95.0|0.87|1.05||||||||1.05|0.87|
71922189|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-2.25|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-5.83|1.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||1.32|-5.83|
71922190|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-3.97|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-9.5|1.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.56|-9.50|
71922191|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-9.52|1.18|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||1.18|-9.52|
71922192|NCT03091920|143365001|OTHER|No statistical testing was performed.|Least squares mean difference|-4.07|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-9.01|0.87|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||0.87|-9.01|
71922193|NCT03091920|143365002|OTHER|No statistical testing was performed.|Least squares mean difference|-3.4|STANDARD_ERROR_OF_MEAN|2.22|||TWO_SIDED|95.0|-8.01|1.21|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.21|-8.01|
71922194|NCT03091920|143365002|OTHER|No statistical testing was performed.|Least squares mean difference|-3.6|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-8.21|1.02|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||1.02|-8.21|
71922195|NCT03091920|143365002|OTHER|No statistical testing was performed.|Least squares mean difference|-3.3|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-7.53|0.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||0.92|-7.53|
71865183|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.06||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-iT connectivity induced by active versus sham rTMS.||||0.06
71865184|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
71865185|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.69||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in cM-cT connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.69
71865186|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.14||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in cM-cT connectivity induced by active versus sham rTMS.||||0.14
71865187|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.12||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during active rTMS (post-rTMS versus pre-rTMS).||||0.12
71865188|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.6||||||The threshold for statistical significance was p \< 0.0076.|Wilcoxon signed rank test|||Within-group analysis of change in iM-cM connectivity during sham rTMS (post-rTMS versus pre-rTMS).||||0.60
71865189|NCT04325282|143245662|OTHER|Given the multiple ROIs investigated, we adjusted significance thresholds using principal component analysis, which accounts for the effective number of independent tests. This method is suitable when data in each comparison are not completely independent, as is the case with EEG where signal represents summated activity from multiple regions.||||||0.04||||||The threshold for statistical significance was p \< 0.0071.|Wilcoxon signed rank test|||Between-group analysis of change in iM-cM connectivity induced by active versus sham rTMS.||||0.04
71865190|NCT00527787|143245665|SUPERIORITY_OR_OTHER||proportions|4.1||||0.001|TWO_SIDED|95.0|1.9|7.7|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||7.7|1.9|0.001
71865191|NCT00527787|143245666|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71865192|NCT00527787|143245667|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71865193|NCT00527787|143245668|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|||||||0.003
71865194|NCT00527787|143245669|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71865195|NCT02783027|143245715|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|Two sample t-test on the change in sleep quality from baseline to 4 months.||||||0.76
71865196|NCT02783027|143245716|SUPERIORITY||||||<|0.0001||||||Test for group\*time interaction.|Mixed Models Analysis|||||||<0.0001
71865197|NCT02783027|143245717|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
71865198|NCT02783027|143245718|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Test for group\*time interaction.||||||<0.0001
71865199|NCT02783027|143245719|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|Two sample t-test for change in Occupational Fatigue Exhaustion Recovery (OFER) inter-shift recovery between groups||||||0.91
71865200|NCT02383940|143245720|SUPERIORITY||Least squares mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.207||0.1|TWO_SIDED|95.0|-0.76|0.06||Threshold for significance = 0.05|MMRM||Difference is sotagliflozin - placebo|Between-group comparison was based on MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.||0.06|-0.76|0.10
71865201|NCT02672852|143245725|OTHER||Adjusted percentage difference|70.8|||<|0.001|TWO_SIDED|95.0|65.7|76.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||76.0|65.7|< 0.001
71865202|NCT02672852|143245726|OTHER||Adjusted percentage difference|76.5|||<|0.001|TWO_SIDED|95.0|70.4|82.5|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||82.5|70.4|< 0.001
71865203|NCT02672852|143245727|OTHER||Adjusted percentage difference|25.9|||<|0.001|TWO_SIDED|95.0|17.3|34.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||34.6|17.3|< 0.001
71865204|NCT02672852|143245728|OTHER||Adjusted percentage difference|80.6|||<|0.001|TWO_SIDED|95.0|74.5|86.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||86.6|74.5|< 0.001
71865205|NCT02672852|143245729|OTHER||Adjusted percentage difference|45.5|||<|0.001|TWO_SIDED|95.0|40.3|50.8|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.8|40.3|< 0.001
71865206|NCT02672852|143245730|OTHER||Adjusted percentage difference|44.8|||<|0.001|TWO_SIDED|95.0|39.5|50.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||50.0|39.5|< 0.001
71865207|NCT02672852|143245731|OTHER||Adjusted percentage difference|62.1|||<|0.001|TWO_SIDED|95.0|56.4|67.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||67.9|56.4|< 0.001
71865208|NCT02672852|143245732|OTHER||Adjusted percentage difference|73.9|||<|0.001|TWO_SIDED|95.0|66.0|81.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||81.9|66.0|< 0.001
71865209|NCT02672852|143245733|OTHER||Adjusted percentage difference|21.2|||<|0.001|TWO_SIDED|95.0|13.7|28.7|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||28.7|13.7|< 0.001
71865210|NCT02672852|143245734|OTHER||Adjusted percentage difference|33.1|||<|0.001|TWO_SIDED|95.0|24.0|42.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||42.2|24.0|< 0.001
71865211|NCT02672852|143245735|OTHER||Adjusted percentage difference|33.7|||<|0.001|TWO_SIDED|95.0|23.2|44.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count \<5).||44.2|23.2|< 0.001
71865212|NCT04308590|143245736|EQUIVALENCE|The primary analysis will determine whether there is a difference between treatment groups in terms of change from Baseline to Week 22 in 24-hour average SBP. This was performed using a linear mixed-model-for-repeated-measures (MMRM) analysis using a placebo wash-out multiple imputation for treatment discontinuation and for patients that use rescue medication.|Least squares mean difference|-2.67||||0.416|TWO_SIDED|95.0|-9.096|3.766|||Mixed Models Analysis|||||3.766|-9.096|0.4160
71910805|NCT01601704|143342139|NON_INFERIORITY_OR_EQUIVALENCE|At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.|Cox Proportional Hazard|0.88|||||TWO_SIDED|99.7|0.57|1.34|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.34|0.57|
71910806|NCT01601704|143342140|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93|||||TWO_SIDED|99.7|0.66|1.33|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.33|0.66|
71910807|NCT01601704|143342141|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.5|||||TWO_SIDED|99.7|0.21|1.19|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.19|0.21|
71910808|NCT01601704|143342142|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.96|||||TWO_SIDED|99.7|0.55|1.67|||||Hazard ratio is based on CPH model with treatment as a factor.|||1.67|0.55|
71910809|NCT01601704|143342143|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04|||||TWO_SIDED|99.7|0.43|2.55|||||Hazard ratio is based on CPH model with treatment as a factor.|||2.55|0.43|
71910810|NCT03518034|143342145|NON_INFERIORITY|Noninferiority margin in terms of HR is 1.5.|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.78|1.17|||||HR of AndroGel to placebo and 95% CI were estimated from Cox proportional-hazards regression model, with adjustment for pre-existing CVD.|The hazard ratio (HR) and 2-sided 95% confidence interval (CI) were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing cardiovascular disease (CVD) status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of MACE. If a subject does not experience a MACE during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.17|0.78|
71910811|NCT03518034|143342147|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.86|1.21|||||HR of AndroGel to placebo and 2-sided 95% CI were estimated from a Cox proportional-hazards regression model with adjustment of pre-existing CVD status.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a participant is defined as the time from randomization to the first component event of CV safety endpoint. If a participant does not experience a CV safety endpoint during the study, the time is right-censored at the time of participant's last available follow-up observation.||1.21|0.86|
71910812|NCT03518034|143342148|SUPERIORITY||Hazard Ratio (HR)|1.62|||||TWO_SIDED|95.0|0.39|6.77|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior cardiovascular disease (CVD).|The high grade prostate cancer endpoint was analyzed using a discrete time proportional hazard regression model with event time intervals based on scheduled visits, and adjusting for pre-existing CVD status. The HR of AndroGel to Placebo and its 2-sided 95% CI were provided.||6.77|0.39|
71682434|NCT01162122|142883155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.4|||||TWO_SIDED|95.0|1.32|1.49||||||||1.49|1.32|
71682435|NCT01162122|142883155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.61|||||TWO_SIDED|95.0|1.52|1.7||||||||1.7|1.52|
71865213|NCT02551653|143245819|OTHER||Mean Ratio|0.832|||||TWO_SIDED|95.0|0.682|0.979|||||||Volume of Distribution - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|0.979|0.682|
71865214|NCT02551653|143245819|OTHER||Mean Ratio|1.472|||||TWO_SIDED|95.0|1.113|1.891|||||||Volume of Distribution - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.891|1.113|
71865215|NCT02551653|143245819|OTHER||Mean Ratio|0.958|||||TWO_SIDED|95.0|0.692|1.241|||||||Volume of Distribution - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.241|0.692|
71865216|NCT02551653|143245820|OTHER||Mean Ratio|1.013|||||TWO_SIDED|95.0|0.846|1.189|||||||Mean Standardized Uptake Values - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.189|0.846|
71865217|NCT02551653|143245820|OTHER||Mean Ratio|1.056|||||TWO_SIDED|95.0|0.853|1.269|||||||Mean Standardized Uptake Values - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.269|0.853|
71682436|NCT01162122|142883155|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.15|||||TWO_SIDED|95.0|1.08|1.21||||||||1.21|1.08|
71865218|NCT02551653|143245820|OTHER||Mean Ratio|1.047|||||TWO_SIDED|95.0|0.786|1.34|||||||Mean Standardized Uptake Values - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.|1.340|0.786|
71865219|NCT02683785|143245821|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value,Treatment Group,Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used.p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented.|||0.58|-1.31|0.442
71682437|NCT01162122|142883156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H1N1 strain)|9.2|||||TWO_SIDED|95.0|7.1|11.3||||||||11.3|7.1|
71865220|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.46||||0.046|TWO_SIDED|95.0|-0.9|-0.01||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||-0.01|-0.90|0.046
71865221|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.38||||0.257|TWO_SIDED|95.0|-1.05|0.29||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.29|-1.05|0.257
71865222|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.5||||0.22|TWO_SIDED|95.0|-1.31|0.31||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.31|-1.31|0.220
71865223|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.74||||0.085|TWO_SIDED|95.0|-1.59|0.11||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.11|-1.59|0.085
71865224|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.36||||0.442|TWO_SIDED|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.58|-1.31|0.442
71682438|NCT01162122|142883156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.5|14.9||||||||14.9|10.5|
71682439|NCT01162122|142883156|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (B strain)|5.2|||||TWO_SIDED|95.0|3.0|7.4||||||||7.4|3.0|
71682440|NCT01162122|142883157|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.37|||||TWO_SIDED|95.0|1.29|1.46||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.46|1.29|
71682441|NCT01162122|142883157|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.6|||||TWO_SIDED|95.0|1.51|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.51|
71682442|NCT01162122|142883157|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.14|||||TWO_SIDED|95.0|1.08|1.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.2|1.08|
71865225|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.83||||0.139|TWO_SIDED|95.0|-1.93|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.28|-1.93|0.139
71865226|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.9||||0.103|TWO_SIDED|95.0|-2.0|0.19||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||0.19|-2.00|0.103
71865227|NCT02683785|143245822|OTHER||Mean Difference (Net)|-0.89||||0.132|TWO_SIDED|95.0|-2.06|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.28|-2.06|0.132
71865228|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.45||||0.082|TWO_SIDED|95.0|-0.97|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented.|||0.06|-0.97|0.082
71865229|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.27||||0.426|TWO_SIDED|95.0|-0.96|0.41||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||0.41|-0.96|0.426
71865230|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.6||||0.129|TWO_SIDED|95.0|-1.38|0.18||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented|||0.18|-1.38|0.129
71865231|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.78||||0.067|TWO_SIDED|95.0|-1.63|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented.|||0.06|-1.63|0.067
71682443|NCT01162122|142883158|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|8.9|||||TWO_SIDED|95.0|6.9|10.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||10.9|6.9|
71682444|NCT01162122|142883158|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|12.7|||||TWO_SIDED|95.0|10.6|14.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||14.8|10.6|
71865232|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.33||||0.494|TWO_SIDED|95.0|-1.28|0.63||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||0.63|-1.28|0.494
71865233|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.94||||0.107|TWO_SIDED|95.0|-2.08|0.21||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented.|||0.21|-2.08|0.107
71865234|NCT02683785|143245823|OTHER||Mean Difference (Net)|-0.98||||0.092|TWO_SIDED|95.0|-2.13|0.17||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented.|||0.17|-2.13|0.092
71865235|NCT02683785|143245823|OTHER||Mean Difference (Net)|-1.01||||0.098|TWO_SIDED|95.0|-2.22|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.|||0.20|-2.22|0.098
71682445|NCT01162122|142883158|SUPERIORITY_OR_OTHER||Group difference (B strain)|5.1|||||TWO_SIDED|95.0|2.9|7.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||7.2|2.9|
71682446|NCT01162122|142883162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H1N1 strain)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||||1.52|1.25|
71865236|NCT02683785|143245828|OTHER||Mean Difference (Net)|-2.8||||0.061|TWO_SIDED|95.0|-5.6|0.1||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 1|||0.1|-5.6|0.061
71865237|NCT02683785|143245828|OTHER||Mean Difference (Net)|-2.0||||0.282|TWO_SIDED|95.0|-5.6|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Pain component, Week 2|||1.7|-5.6|0.282
71865238|NCT02683785|143245828|OTHER||Mean Difference (Net)|-3.7||||0.113|TWO_SIDED|95.0|-8.4|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component Week 4|||0.9|-8.4|0.113
71865239|NCT02683785|143245828|OTHER||Mean Difference (Net)|-1.0||||0.695|TWO_SIDED|95.0|-5.9|4.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 6|||4.0|-5.9|0.695
71865240|NCT02683785|143245828|OTHER||Mean Difference (Net)|-3.8||||0.176|TWO_SIDED|95.0|-9.4|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 8|||1.8|-9.4|0.176
71865241|NCT02683785|143245828|OTHER||Mean Difference (Net)|-5.5||||0.041|TWO_SIDED|95.0|-10.8|-0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 10|||-0.2|-10.8|0.041
71865242|NCT02683785|143245828|OTHER||Mean Difference (Net)|-4.7||||0.082|TWO_SIDED|95.0|-10.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 12|||0.6|-10.1|0.082
71865243|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.2||||0.587|TWO_SIDED|95.0|-1.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 1|||0.6|-1.1|0.587
71865244|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.4||||0.457|TWO_SIDED|95.0|-1.3|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 2|||0.6|-1.3|0.457
71865245|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.6||||0.298|TWO_SIDED|95.0|-1.8|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 4|||0.6|-1.8|0.298
71865246|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.2||||0.726|TWO_SIDED|95.0|-1.3|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 6|||0.9|-1.3|0.726
71865247|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.7||||0.213|TWO_SIDED|95.0|-1.9|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 8|||0.4|-1.9|0.213
71865248|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.6||||0.331|TWO_SIDED|95.0|-1.9|0.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 10|||0.7|-1.9|0.331
71865249|NCT02683785|143245828|OTHER||Mean Difference (Net)|-0.8||||0.248|TWO_SIDED|95.0|-2.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 12|||0.6|-2.1|0.248
71865250|NCT02683785|143245828|OTHER||Mean Difference (Net)|-2.9||||0.35|TWO_SIDED|95.0|-9.0|3.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 1|||3.3|-9.0|0.350
71922196|NCT03091920|143365002|OTHER|No statistical testing was performed.|Least squares mean difference|-2.01|STANDARD_ERROR_OF_MEAN|2.04|||TWO_SIDED|95.0|-6.24|2.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.23|-6.24|
71922197|NCT03091920|143365002|OTHER|No statistical testing was performed.|Least squares mean difference|-7.29|STANDARD_ERROR_OF_MEAN|2.65|||TWO_SIDED|95.0|-12.8|-1.79|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||-1.79|-12.80|
71922198|NCT03091920|143365002|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-10.43|0.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||0.23|-10.43|
71910813|NCT03518034|143342149|SUPERIORITY|||||||0.011||||||P-value is derived from the omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using linear mixed regression model.|linear mixed regression model|Omnibus likelihood-ratio chi-square test from linear mixed regression model||A linear mixed regression model was used to analyze the change in PDQ-Q4 from baseline to months 6, 12, and 24, with the dependent variable being the change in PDQ-Q4 score. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CVD status. An unstructured covariance matrix was used to account for correlations among repeated measures within-subject.||||0.011
71865251|NCT02683785|143245828|OTHER||Mean Difference (Net)|-3.0||||0.383|TWO_SIDED|95.0|-9.8|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 2|||3.8|-9.8|0.383
71865252|NCT02683785|143245828|OTHER||Mean Difference (Net)|-4.8||||0.271|TWO_SIDED|95.0|-13.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 4|||3.9|-13.5|0.271
71865253|NCT02683785|143245828|OTHER||Mean Difference (Net)|-2.7||||0.565|TWO_SIDED|95.0|-12.1|6.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 6|||6.7|-12.1|0.565
71865254|NCT02683785|143245828|OTHER||Mean Difference (Net)|-4.9||||0.343|TWO_SIDED|95.0|-15.2|5.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 8|||5.4|-15.2|0.343
71865255|NCT02683785|143245828|OTHER||Mean Difference (Net)|-6.2||||0.266|TWO_SIDED|95.0|-17.3|4.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 10|||4.9|-17.3|0.266
71865256|NCT02683785|143245828|OTHER||Mean Difference (Net)|-8.2||||0.136|TWO_SIDED|95.0|-19.1|2.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 12|||2.7|-19.1|0.136
71865257|NCT02683785|143245828|OTHER||Mean Difference (Net)|-5.5||||0.23|TWO_SIDED|95.0|-14.5|3.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 1|||3.6|-14.5|0.230
71865258|NCT02683785|143245828|OTHER||Mean Difference (Net)|-4.6||||0.381|TWO_SIDED|95.0|-15.2|5.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 2|||5.9|-15.2|0.381
71865259|NCT02683785|143245828|OTHER||Mean Difference (Net)|-8.7||||0.207|TWO_SIDED|95.0|-22.4|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 4|||5.0|-22.4|0.207
71865260|NCT02683785|143245828|OTHER||Mean Difference (Net)|-3.4||||0.648|TWO_SIDED|95.0|-18.4|11.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 6|||11.6|-18.4|0.648
71865261|NCT02683785|143245828|OTHER||Mean Difference (Net)|-9.0||||0.278|TWO_SIDED|95.0|-25.4|7.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 8|||7.5|-25.4|0.278
71865262|NCT02683785|143245828|OTHER||Mean Difference (Net)|-12.1||||0.16|TWO_SIDED|95.0|-29.1|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 10|||5.0|-29.1|0.160
71865263|NCT02683785|143245828|OTHER||Mean Difference (Net)|-13.3||||0.127|TWO_SIDED|95.0|-30.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 12|||3.9|-30.5|0.127
71910814|NCT03518034|143342149|SUPERIORITY||LS Mean of Difference|0.49|||||TWO_SIDED|95.0|0.19|0.79|||||LS mean difference (AndroGel - Placebo) at month 6 was derived from linear mixed regression model.|Month 6 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.79|0.19|
71682447|NCT01162122|142883162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (H3N2 strain)|1.57|||||TWO_SIDED|95.0|1.44|1.72||||||||1.72|1.44|
71865264|NCT02683785|143245829|OTHER||Mean Difference (Net)|0.0||||0.957|TWO_SIDED|95.0|-1.9|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||1.8|-1.9|0.957
71865265|NCT02683785|143245829|OTHER||Mean Difference (Net)|0.3||||0.775|TWO_SIDED|95.0|-2.1|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.8|-2.1|0.775
71865266|NCT02683785|143245829|OTHER||Mean Difference (Net)|-0.5||||0.624|TWO_SIDED|95.0|-2.7|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||1.7|-2.7|0.624
71865267|NCT02683785|143245829|OTHER||Mean Difference (Net)|1.4||||0.243|TWO_SIDED|95.0|-1.0|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.8|-1.0|0.243
71865268|NCT02683785|143245829|OTHER||Mean Difference (Net)|0.2||||0.875|TWO_SIDED|95.0|-2.5|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.9|-2.5|0.875
71865269|NCT02683785|143245829|OTHER||Mean Difference (Net)|-0.3||||0.848|TWO_SIDED|95.0|-3.4|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||2.8|-3.4|0.848
71865270|NCT02683785|143245829|OTHER||Mean Difference (Net)|-0.2||||0.883|TWO_SIDED|95.0|-2.8|2.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||2.4|-2.8|0.883
71865271|NCT02683785|143245830|OTHER||Mean Difference (Net)|-1.2||||0.463|TWO_SIDED|95.0|-4.4|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented|||2.0|-4.4|0.463
71865272|NCT02683785|143245830|OTHER||Mean Difference (Net)|-0.4||||0.809|TWO_SIDED|95.0|-3.7|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||2.9|-3.7|0.809
71865273|NCT02683785|143245830|OTHER||Mean Difference (Net)|-1.9||||0.324|TWO_SIDED|95.0|-5.8|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||2.0|-5.8|0.324
71865274|NCT02683785|143245830|OTHER||Mean Difference (Net)|-0.5||||0.783|TWO_SIDED|95.0|-4.2|3.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented|||3.2|-4.2|0.783
71865275|NCT02683785|143245830|OTHER||Mean Difference (Net)|-1.4||||0.464|TWO_SIDED|95.0|-5.4|2.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||2.5|-5.4|0.464
71865276|NCT02683785|143245830|OTHER||Mean Difference (Net)|-0.7||||0.736|TWO_SIDED|95.0|-4.9|3.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented|||3.5|-4.9|0.736
71865277|NCT02683785|143245830|OTHER||Mean Difference (Net)|-0.5||||0.806|TWO_SIDED|95.0|-4.8|3.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||3.7|-4.8|0.806
71865278|NCT02683785|143245831|OTHER||Mean Difference (Net)|0.3||||0.586|TWO_SIDED|95.0|-0.9|1.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented|||1.6|-0.9|0.586
71865279|NCT02683785|143245831|OTHER||Mean Difference (Net)|-0.5||||0.416|TWO_SIDED|95.0|-1.9|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.8|-1.9|0.416
71682448|NCT01162122|142883162|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was \>0.67.|GMT ratio (B strain)|1.12|||||TWO_SIDED|95.0|1.03|1.21||||||||1.21|1.03|
71865280|NCT02683785|143245831|OTHER||Mean Difference (Net)|-1.2||||0.12|TWO_SIDED|95.0|-2.8|0.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.3|-2.8|0.120
71865281|NCT02683785|143245831|OTHER||Mean Difference (Net)|-0.3||||0.687|TWO_SIDED|95.0|-2.1|1.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||1.4|-2.1|0.687
71865282|NCT02683785|143245832|OTHER||Mean Difference (Net)|-0.2||||0.651|TWO_SIDED|95.0|-1.3|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented.|||0.8|-1.3|0.651
71865283|NCT02683785|143245832|OTHER||Mean Difference (Net)|-0.7||||0.271|TWO_SIDED|95.0|-1.9|0.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented|||0.5|-1.9|0.271
71865284|NCT02683785|143245832|OTHER||Mean Difference (Net)|-0.9||||0.186|TWO_SIDED|95.0|-2.2|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented|||0.4|-2.2|0.186
71865285|NCT02683785|143245832|OTHER||Mean Difference (Net)|-1.1||||0.109|TWO_SIDED|95.0|-2.4|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented|||0.2|-2.4|0.109
71865286|NCT01346072|143245847|SUPERIORITY|||||||0.853|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.853
71865287|NCT01346072|143245848|SUPERIORITY|||||||0.035|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported||||||0.035
71865288|NCT02233803|143245849|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority (NI) is demonstrated as the lower limit of CI for the difference is greater than the pre-specified NI margin of -1.25ML. The lower limit of the 95% CI for the treatment difference (NEUMOTEROL 400 -Symbicort Forte) was greater than the pre-specified non-inferiority margin of -1.25 mL.|Difference of LS means|0.044|||||TWO_SIDED|95.0|-0.008|0.096||||||Sample size calculations are based on the primary efficacy endpoint (change from baseline in trough FEV1 at day 29). Assuming a within-subject standard deviation of 210 mL, 168 completed subjects are required to demonstrate the non-inferiority of BFF 400/12 mcg SINGLE CAPSULE INHALER and BFF 320/9 mcg TURBUHALER BID, assuming a true difference of -50 mL with 90% power and a 2.5% one-sided significance level. The pre-specified NI margin is set at -1.25mL.||0.096|-0.008|
71865289|NCT02233803|143245850|SUPERIORITY_OR_OTHER||Difference of LS means|0.98|||||TWO_SIDED|95.0|0.576|1.384||||||||1.384|0.576|
71865290|NCT02233803|143245851|SUPERIORITY_OR_OTHER||Difference of LS means|0.6|||||TWO_SIDED|95.0|0.1|1.1||||||||1.1|0.1|
71865291|NCT03635099|143245852|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
71865292|NCT03635099|143245852|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
71865293|NCT03635099|143245852|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
71865294|NCT03635099|143245852|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
71865295|NCT03635099|143245852|OTHER||Risk Difference (RD)|25.6|||||TWO_SIDED|95.0|12.5|38.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||38.6|12.5|
71922199|NCT03091920|143365003|OTHER|No statistical testing was performed.|Least squares mean difference|0.99|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-2.97|4.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.95|-2.97|
71922200|NCT03091920|143365003|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|-3.41|4.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||4.52|-3.41|
71922201|NCT03091920|143365003|OTHER|No statistical testing was performed.|Least squares mean difference|-2.54|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.63|2.56|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.56|-7.63|
71922202|NCT03091920|143365003|OTHER|No statistical testing was performed.|Least squares mean difference|-2.26|STANDARD_ERROR_OF_MEAN|2.46|||TWO_SIDED|95.0|-7.36|2.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||2.85|-7.36|
71682449|NCT01162122|142883163|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H1N1 strain)|11.1|||||TWO_SIDED|95.0|7.5|14.6||||||||14.6|7.5|
71682450|NCT01162122|142883163|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H3N2 strain)|13.5|||||TWO_SIDED|95.0|9.8|17.2||||||||17.2|9.8|
71865296|NCT03635099|143245852|OTHER||Risk Difference (RD)|23.8|||||TWO_SIDED|95.0|10.9|36.7|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.7|10.9|
71865297|NCT03635099|143245852|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0004
71865298|NCT03635099|143245852|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0012||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0012
71865299|NCT03635099|143245852|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0008||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0008
71865300|NCT03635099|143245852|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0217||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0217
71865301|NCT03635099|143245852|OTHER|First the response rate of PASI 75 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline PASI score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
71865302|NCT03635099|143245853|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
71865303|NCT03635099|143245853|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
71682451|NCT01162122|142883163|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (B strain)|5.0|||||TWO_SIDED|95.0|1.4|8.5||||||||8.5|1.4|
71865304|NCT03635099|143245853|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
71865305|NCT03635099|143245853|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
71865306|NCT03635099|143245853|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0007||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Linear model fit.|||||||0.0007
71865307|NCT03635099|143245853|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0023||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Logistic model fit.|Model assumption: 10% of the maximum effect is achieved at 25 mg and 80% of the maximum effect is achieved at 100 mg.||||||0.0023
71922203|NCT03091920|143365003|OTHER|No statistical testing was performed.|Least squares mean difference|-1.03|STANDARD_ERROR_OF_MEAN|3.13|||TWO_SIDED|95.0|-7.55|5.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||5.49|-7.55|
71865308|NCT03635099|143245853|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0018||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax1 model fit.|Model assumption: 30% of the maximum effect is achieved at 50 mg.||||||0.0018
71910815|NCT03518034|143342149|SUPERIORITY||LS Mean of Difference|0.47|||||TWO_SIDED|95.0|0.11|0.83|||||LS mean difference (AndroGel - Placebo) at month 12 was derived from linear mixed regression model.|Month 12 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.83|0.11|
71910816|NCT03518034|143342149|SUPERIORITY||LS Mean of Difference|0.48|||||TWO_SIDED|95.0|-0.01|0.96|||||LS mean difference (AndroGel - Placebo) at month 24 was derived from linear mixed regression model.|Month 24 (results were derived from a linear mixed regression model that had a dependent variable of the change in PDQ-Q4 from baseline to months 6, 12, and 24. The model included fixed effects for treatment, visit, and the interaction between treatment and visit, while adjusting for baseline PDQ-Q4 score and pre-existing CV disease status. Additionally, an unstructured covariance matrix was used to account for correlations among repeated measures within participants).||0.96|-0.01|
71910817|NCT03518034|143342150|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.96|3.86||||||Month 6 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.86|0.96|
71910818|NCT03518034|143342150|SUPERIORITY||Risk Ratio (RR)|1.52|||||TWO_SIDED|95.0|0.64|3.63||||||Month 12 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||3.63|0.64|
71910819|NCT03518034|143342150|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.42|1.94||||||Month 24 risk ratio of remission of LG-PDD in the AndroGel versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||1.94|0.42|
71910820|NCT03518034|143342150|SUPERIORITY|||||||0.197||||||The omnibus test p value is a test of the null hypothesis of no difference between AndroGel and placebo groups across all time points.|GEE Poisson regression model|||Risk ratio of remission of LG-PDD in the TRT versus placebo group was estimated by a repeated measures generalized estimating equations (GEE) Poisson regression model with fixed effects for treatment, visit, treatment-visit interaction, pre- existing CVD, and an unstructured working correlation matrix to account for repeated measures at multiple visits.||||0.197
71910821|NCT03518034|143342152|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|1.04|1.97|||||Cox proportional-hazards model.|The HR and 2-sided 95% CI were calculated using a Cox proportional-hazards regression model, with adjustment for pre-existing CVD status. In this analysis, the time to event for a subject is defined as the time from randomization to the first occurrence of a clinical fracture. If a subject does not experience a clinic fracture during the study, the follow-up time is right-censored at the time of subject's last available follow-up observation.||1.97|1.04|
71910822|NCT03518034|143342153|OTHER|||||||0.002||||||p-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|omnibus likelihood-ratio chi-square test|||Repeated measures log-binomial regression with effects for treatment, visit, treatment-by-visit interaction, and adjusted for pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.002
71910823|NCT03518034|143342154|SUPERIORITY|||||||0.494||||||P-value is from an omnibus likelihood-ratio chi-square test of the current model versus the null (intercept) model using repeated measure log-binomial regression.|Repeated measures log-binomial regr.|||The risk ratio of progression to diabetes in the AndroGel versus placebo group was estimated by a repeated measures log-binomial regression with fixed effects for treatment, visit, treatment-visit interaction, and pre-existing CVD, and an unstructured covariance matrix to account for correlations among repeated measures within-subject.||||0.494
71682452|NCT01162122|142883164|SUPERIORITY_OR_OTHER||GMT ratio (H1N1 strain)|1.32|||||TWO_SIDED|95.0|1.2|1.45||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.45|1.2|
71910824|NCT03518034|143342155|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.78|1.23|||||Cox proportional-hazards model adjusting for prior CVD.|||1.23|0.78|
71910825|NCT03518034|143342156|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.76|1.62|||||Cox proportional-hazards model adjusting for prior CVD.|||1.62|0.76|
71910826|NCT03518034|143342157|SUPERIORITY||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|0.92|2.32|||||Cox proportional-hazards model adjusting for prior CVD.|||2.32|0.92|
71910827|NCT03518034|143342158|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.56|1.51|||||Cox proportional-hazards model adjusting for prior CVD.|||1.51|0.56|
71910828|NCT03518034|143342159|SUPERIORITY||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.55|2.31|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.31|0.55|
71910829|NCT03518034|143342160|SUPERIORITY||Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.47|2.42|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.42|0.47|
71910830|NCT03518034|143342161|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.65|2.41|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||2.41|0.65|
71865309|NCT03635099|143245853|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0386||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Emax2 model fit.|Model assumption: 80% of the maximum effect is achieved at 50 mg.||||||0.0386
71910831|NCT03518034|143342162|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.87|1.54|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||1.54|0.87|
71910832|NCT03518034|143342163|SUPERIORITY||Hazard Ratio (HR)|1.91|||||TWO_SIDED|95.0|0.95|3.84|||||Discrete-time proportional hazards model with event time intervals based on scheduled visits, and adjusting for prior CVD.|||3.84|0.95|
71682453|NCT01162122|142883164|SUPERIORITY_OR_OTHER||GMT ratio (H3N2 strain)|1.54|||||TWO_SIDED|95.0|1.42|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.68|1.42|
71910833|NCT00150345|143342194|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.493||||0.258|TWO_SIDED|95.0|0.129|1.755|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event IFI=yes is modeled.|Hypothesis: H0: rv - rp = 0 vs H1: rv - rp does not equal 0, where ri is rate of IFI (i=v for voriconazole group, i=p for deferred voriconazole group). Logit model (including important covariates) used. The adjusted odds ratio and 95 percent (%) confidence interval (CI) for adjusted odds ratio calculated. If 95% CI around odds ratio does not contain a value of 1, then the null hypothesis of equal rates of IFI between immediate voriconazole and deferred voriconazole to be rejected.||1.755|0.129|0.258
71910834|NCT00150345|143342195|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.596|TWO_SIDED|95.0|0.398|1.696|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.696|0.398|0.596
71910835|NCT00150345|143342196|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.864|TWO_SIDED|95.0|0.441|1.988|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.|||1.988|0.441|0.864
71910836|NCT00150345|143342197|SUPERIORITY_OR_OTHER|||||||0.955|TWO_SIDED||||||Log Rank|||||||0.955
71910837|NCT00150345|143342199|SUPERIORITY_OR_OTHER||Difference in % participants that died|5.85|||||TWO_SIDED|95.0|-5.08|16.78|||||Approximate 2-sided confidence interval (CI).|Difference in proportions expressed as a percent: immediate voriconazole versus (vs) deferred voriconazole treatment||16.78|-5.08|
71910838|NCT00150345|143342200|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Log Rank|||||||0.190
71910839|NCT00150345|143342201|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.031|STANDARD_ERROR_OF_MEAN|10.888||0.049|TWO_SIDED|95.0|-44.004|-0.059||SAS PROC REG with SELECTION=STEPWISE option of SLENTRY=0.05 and SLSTAY=0.10 utilized. Stepwise option combined forward stepping (with a 0.05 level to enter) with elimination of variables already in model that do not stay significant at 0.10 level.|Regression, Linear|Variables: association with age, c-reactive protein, and time to continuous defervescence not significant at 0.05 level; not included in final model||Continuous defervescence achieved=Yes||-0.059|-44.004|0.049
71910840|NCT00150345|143342221|SUPERIORITY_OR_OTHER||Difference in percentages|2.51|||||TWO_SIDED|95.0|-14.96|19.97||||||Difference in proportions expressed as a percent: immediate voriconazole vs deferred voriconazole treatment||19.97|-14.96|
71682454|NCT01162122|142883164|SUPERIORITY_OR_OTHER||GMT ratio (B strain)|1.11|||||TWO_SIDED|95.0|1.03|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was \>1.5.||1.21|1.03|
71682455|NCT01162122|142883168|SUPERIORITY_OR_OTHER||Group difference (H1N1 strain)|9.9|||||TWO_SIDED|95.0|6.4|13.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||13.3|6.4|
71865310|NCT03635099|143245853|OTHER|First the response rate of sPGA 0/1 at week 12 for each dosage group was estimated by a logistic regression model including the fixed effect of treatment (categorical dose) and baseline sPGA score as covariate was performed. The dose-response relationships were then tested using the Multiple Comparison Procedures and Modelling (MCP-Mod) approach based on the estimates from logistic regression.||||||0.0004||||||The multiple comparison procedure was implemented using optimal contrast tests which control the family-wise type I error rate at one-sided α = 0.05.|MCPMod Exponential model fit.|Model assumption: 5% of the maximum effect is achieved at 25 mg.||||||0.0004
71865311|NCT03635099|143245854|OTHER||Risk Difference (RD)|0.0||||1|TWO_SIDED|95.0|-11.7|11.7|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.7|-11.7|1.0000
71865312|NCT03635099|143245854|OTHER||Risk Difference (RD)|20.6||||0.054|TWO_SIDED|95.0|3.9|37.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||37.3|3.9|0.0540
71865313|NCT03635099|143245854|OTHER||Risk Difference (RD)|15.5||||0.1167|TWO_SIDED|95.0|-0.4|31.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||31.4|-0.4|0.1167
71865314|NCT03635099|143245854|OTHER||Risk Difference (RD)|45.0||||0.0006|TWO_SIDED|95.0|26.8|63.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||63.2|26.8|0.0006
71865315|NCT03635099|143245854|OTHER||Risk Difference (RD)|45.8|||||TWO_SIDED|95.0|22.0|69.6|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||69.6|22.0|
71865316|NCT03635099|143245854|OTHER||Risk Difference (RD)|35.2|||||TWO_SIDED|95.0|11.3|59.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||59.2|11.3|
71922204|NCT03091920|143365003|OTHER|No statistical testing was performed.|Least squares mean difference|-3.68|STANDARD_ERROR_OF_MEAN|3.04|||TWO_SIDED|95.0|-10.0|2.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||2.65|-10.00|
71865317|NCT03635099|143245855|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
71865318|NCT03635099|143245855|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
71865319|NCT03635099|143245855|OTHER||Risk Difference (RD)|17.5||||0.0465|TWO_SIDED|95.0|5.7|29.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||29.3|5.7|0.0465
71865320|NCT03635099|143245855|OTHER||Risk Difference (RD)|9.3|||||TWO_SIDED|95.0|0.6|18.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||18.0|0.6|
71865321|NCT03635099|143245855|OTHER||Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-1.7|11.2|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||11.2|-1.7|
71865322|NCT03635099|143245856|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
71865323|NCT03635099|143245856|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
71865324|NCT03635099|143245856|OTHER||Risk Difference (RD)|2.3|||||TWO_SIDED|95.0|-2.2|6.8|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||6.8|-2.2|
71865325|NCT03635099|143245856|OTHER||Risk Difference (RD)|2.4|||||TWO_SIDED|95.0|-2.2|7.0|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||7.0|-2.2|
71865326|NCT03635099|143245857|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
71865327|NCT03635099|143245857|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
71865328|NCT03635099|143245857|OTHER||Risk Difference (RD)|12.8||||0.0942|TWO_SIDED|95.0|2.3|23.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||23.3|2.3|0.0942
71682456|NCT01162122|142883168|SUPERIORITY_OR_OTHER||Group difference (H3N2 strain)|13.0|||||TWO_SIDED|95.0|9.5|16.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||16.6|9.5|
71682457|NCT01162122|142883168|SUPERIORITY_OR_OTHER||Group difference (B strain)|4.9|||||TWO_SIDED|95.0|1.5|8.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was \>10%.||8.3|1.5|
71910841|NCT01457924|143342228|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||Note: There is a discrepancy in the number of par. in ITT populations at Wk 24 and Wk 48: 228 and 229 respectively. This resulted from a data issue: one par was incorrectly excluded from ITT pop. at Wk 24, but correctly included in Wk 48. This error affects all source tables, analyses relating to ITT and per protocol populations, primary endpoint and secondary MRI endpoints reported at Wk 24. This discrepancy affects all statistical analyses, but not summary statistics.||0.548|0.221|<0.001
71910842|NCT01457924|143342228|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
71910843|NCT01457924|143342228|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
71910844|NCT01457924|143342228|SUPERIORITY_OR_OTHER||Ratio|0.35|||<|0.001|TWO_SIDED|95.0|0.221|0.548|||Non-Linear Emax Model|||||0.548|0.221|<0.001
71910845|NCT01457924|143342229|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
71910846|NCT01457924|143342229|SUPERIORITY_OR_OTHER||Ratio|0.38||||0.003|TWO_SIDED|95.0|0.2|0.72|||Generalized Linear Model|||||0.72|0.20|0.003
71910847|NCT01457924|143342229|SUPERIORITY_OR_OTHER||Ratio|0.35||||0.001|TWO_SIDED|95.0|0.19|0.65|||Generalized Linear Model|||||0.65|0.19|0.001
71910848|NCT01457924|143342229|SUPERIORITY_OR_OTHER||Ratio|0.23|||<|0.001|TWO_SIDED|95.0|0.13|0.39|||Generalized Linear Model|||||0.39|0.13|<0.001
71910849|NCT01457924|143342232|SUPERIORITY_OR_OTHER||Ratio|0.31|||<|0.001|TWO_SIDED|95.0|0.16|0.6|||Generalized Linear Model|||||0.60|0.16|<0.001
71910850|NCT01457924|143342232|SUPERIORITY_OR_OTHER||Ratio|0.56||||0.075|TWO_SIDED|95.0|0.29|1.06|||Generalized Linear Model|||||1.06|0.29|0.075
71910851|NCT01457924|143342232|SUPERIORITY_OR_OTHER||Ratio|0.51||||0.035|TWO_SIDED|95.0|0.27|0.95|||Generalized Linear Model|||||0.95|0.27|0.035
71910852|NCT01457924|143342232|SUPERIORITY_OR_OTHER||Ratio|0.32|||<|0.001|TWO_SIDED|95.0|0.19|0.55|||Generalized Linear Model|||||0.55|0.19|<0.001
71910853|NCT01457924|143342233|SUPERIORITY_OR_OTHER||Ratio|0.22||||0.026|TWO_SIDED|95.0|0.06|0.84|||Generalized Linear Model|||||0.84|0.06|0.026
71682458|NCT01162122|142883169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Brisbane-overall)|1.45|||||TWO_SIDED|95.0|1.29|1.63||||||||1.63|1.29|
71682459|NCT01162122|142883169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (H3N2/Wisconsin-overall)|1.36|||||TWO_SIDED|95.0|1.23|1.5||||||||1.5|1.23|
71910854|NCT01457924|143342233|SUPERIORITY_OR_OTHER||Ratio|0.49||||0.296|TWO_SIDED|95.0|0.13|1.86|||Generalized Linear Model|||||1.86|0.13|0.296
71910855|NCT01457924|143342233|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.285|TWO_SIDED|95.0|0.14|1.78|||Generalized Linear Model|||||1.78|0.14|0.285
71910856|NCT01457924|143342233|SUPERIORITY_OR_OTHER||Ratio|0.25||||0.009|TWO_SIDED|95.0|0.09|0.71|||Non-Linear Emax Model|||||0.71|0.09|0.009
71910857|NCT01457924|143342234|SUPERIORITY_OR_OTHER||Ratio|0.18||||0.004|TWO_SIDED|95.0|0.05|0.58|||Generalized Linear Model|||||0.58|0.05|0.004
71910858|NCT01457924|143342234|SUPERIORITY_OR_OTHER||Ratio|0.5||||0.248|TWO_SIDED|95.0|0.15|1.63|||Generalized Linear Model|||||1.63|0.15|0.248
71910859|NCT01457924|143342234|SUPERIORITY_OR_OTHER||Ratio|0.46||||0.181|TWO_SIDED|95.0|0.15|1.43|||Generalized Linear Model|||||1.43|0.15|0.181
71910860|NCT01457924|143342234|SUPERIORITY_OR_OTHER||Ratio|0.24||||0.003|TWO_SIDED|95.0|0.1|0.62|||Generalized Linear Model|||||0.62|0.10|0.003
71910861|NCT01457924|143342235|SUPERIORITY_OR_OTHER||Ratio|0.29|||<|0.001|TWO_SIDED|95.0|0.15|0.58|||Generalized Linear Model|||||0.58|0.15|<0.001
71910862|NCT01457924|143342235|SUPERIORITY_OR_OTHER||Ratio|0.34||||0.002|TWO_SIDED|95.0|0.17|0.68|||Generalized Linear Model|||||0.68|0.17|0.002
71910863|NCT01457924|143342235|SUPERIORITY_OR_OTHER||Ratio|0.4||||0.006|TWO_SIDED|95.0|0.21|0.77|||Generalized Linear Model|||||0.77|0.21|0.006
71910864|NCT01457924|143342235|SUPERIORITY_OR_OTHER||Ratio|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.35|||Generalized Linear Model|||||0.35|0.11|<0.001
71910865|NCT00270998|143342253|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||<0.0492
71910866|NCT00270998|143342253|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.02||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.02
71910867|NCT00270998|143342253|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.49||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.||||0.49
71910868|NCT00270998|143342254|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.006|||||||Regression, Logistic|||||||0.006
71865329|NCT03635099|143245857|OTHER||Risk Difference (RD)|27.5||||0.0095|TWO_SIDED|95.0|13.7|41.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||41.3|13.7|0.0095
71865330|NCT03635099|143245857|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
71865331|NCT03635099|143245857|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
71865332|NCT03635099|143245857|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
71865333|NCT03635099|143245857|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
71865334|NCT03635099|143245857|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
71910869|NCT00270998|143342254|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
71682460|NCT01162122|142883169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.|GMT Ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.98|1.21||||||||1.21|0.98|
71865335|NCT03635099|143245857|OTHER||Risk Difference (RD)|35.0||||0.0025|TWO_SIDED|95.0|20.2|49.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||49.8|20.2|0.0025
71865336|NCT03635099|143245858|OTHER||Risk Difference (RD)|2.6||||0.4701|TWO_SIDED|95.0|-2.4|7.5|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.5|-2.4|0.4701
71865337|NCT03635099|143245858|OTHER||Risk Difference (RD)|5.0||||0.3091|TWO_SIDED|95.0|-1.8|11.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||11.8|-1.8|0.3091
71865338|NCT03635099|143245859|OTHER||Risk Difference (RD)|2.5||||0.4758|TWO_SIDED|95.0|-2.3|7.3|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||7.3|-2.3|0.4758
71865339|NCT03635099|143245859|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
71865340|NCT03635099|143245859|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
71865341|NCT03635099|143245859|OTHER||Risk Difference (RD)|30.0||||0.0062|TWO_SIDED|95.0|15.8|44.2|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||44.2|15.8|0.0062
71865342|NCT03635099|143245859|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
71865343|NCT03635099|143245859|OTHER||Risk Difference (RD)|5.1||||0.3028|TWO_SIDED|95.0|-1.8|12.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||12.1|-1.8|0.3028
71865344|NCT03635099|143245859|OTHER||Risk Difference (RD)|25.0||||0.0143|TWO_SIDED|95.0|11.6|38.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||38.4|11.6|0.0143
71865345|NCT03635099|143245859|OTHER||Risk Difference (RD)|7.7||||0.203|TWO_SIDED|95.0|-0.7|16.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||16.1|-0.7|0.2030
71865346|NCT03635099|143245859|OTHER||Risk Difference (RD)|10.3||||0.138|TWO_SIDED|95.0|0.7|19.8|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||19.8|0.7|0.1380
71865347|NCT03635099|143245859|OTHER||Risk Difference (RD)|32.5||||0.004|TWO_SIDED|95.0|18.0|47.0|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||47.0|18.0|0.0040
71865348|NCT03635099|143245860|OTHER||Adjusted mean|0.5|STANDARD_ERROR_OF_MEAN|1.2||0.7008|TWO_SIDED|95.0|-1.9|2.8|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||2.8|-1.9|0.7008
71865349|NCT03635099|143245860|OTHER||Adjusted mean|0.6|STANDARD_ERROR_OF_MEAN|1.2||0.6268|TWO_SIDED|95.0|-1.8|3.0|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||3.0|-1.8|0.6268
71865350|NCT03635099|143245860|OTHER||Adjusted mean|2.7|STANDARD_ERROR_OF_MEAN|1.2||0.0266|TWO_SIDED|95.0|0.3|5.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.1|0.3|0.0266
71865351|NCT03635099|143245860|OTHER||Adjusted mean|4.0|STANDARD_ERROR_OF_MEAN|1.2||0.0009|TWO_SIDED|95.0|1.7|6.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||6.3|1.7|0.0009
71910870|NCT00270998|143342254|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.42|||||||Regression, Logistic|||||||0.42
71865352|NCT03635099|143245860|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
71865353|NCT03635099|143245860|OTHER||Adjusted mean|3.1|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|95.0|0.4|5.8|||||MMRM model included treatment, visit and treatment by visit as fixed effects, baseline PSS score and baseline PSS by visit as covariates, patient as a random effect, and an unstructured covariance structure for within patient variation.|||5.8|0.4|
71865354|NCT03635099|143245861|OTHER||Risk Difference (RD)|2.5||||0.7144|TWO_SIDED|95.0|-10.1|15.1|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.1|-10.1|0.7144
71865355|NCT03635099|143245861|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
71865356|NCT03635099|143245861|OTHER||Risk Difference (RD)|2.7||||0.697|TWO_SIDED|95.0|-10.0|15.4|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||15.4|-10.0|0.6970
71865357|NCT03635099|143245861|OTHER||Risk Difference (RD)|15.0||||0.125|TWO_SIDED|95.0|-0.6|30.6|||Chi-squared||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|||30.6|-0.6|0.1250
71865358|NCT03635099|143245861|OTHER||Risk Difference (RD)|7.9|||||TWO_SIDED|95.0|-20.3|36.1|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||36.1|-20.3|
71865359|NCT03635099|143245861|OTHER||Risk Difference (RD)|6.2|||||TWO_SIDED|95.0|-21.9|34.3|||||Statistics for the difference were calculated using unadjusted risk differences (BI dose group - Placebo).|The 95% confidence interval for the unadjusted absolute difference in proportion (%) between active group and placebo group was estimated by Chi-square method. As pre-specified, no hypothesis testing was carried out for Part 2 of this trial and no p-values were provided.||34.3|-21.9|
71865360|NCT01840410|143245900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.94|STANDARD_ERROR_OF_MEAN|1.502|<|0.001|TWO_SIDED|95.0|6.97|12.91|||Mixed Models Analysis|||||12.91|6.97|<0.001
71865361|NCT02671500|143245927|SUPERIORITY||||||<|0.001|||||||2-sided 1 sample exact binomial test|||A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.||||<0.001
71865362|NCT00798434|143245952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.12|-0.97|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.||Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).||-0.97|-2.12|<0.0001
71865363|NCT00798434|143245953|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-14.44|||<|0.0001|TWO_SIDED|95.0|-14.67|-14.25|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and confidence interval (CI)|Week 12 LOCF||-14.25|-14.67|<0.0001
71865364|NCT00798434|143245954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.22||0.0001|TWO_SIDED|95.0|-1.28|-0.42|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes||Week 12 LOCF||-0.42|-1.28|0.0001
71865365|NCT00798434|143245955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0005|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.0005
71865366|NCT00798434|143245956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.33|-0.64|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions||Week 12 LOCF||-0.64|-1.33|<0.0001
71865367|NCT00798434|143245957|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.31|||<|0.0001|TWO_SIDED|95.0|-7.4|-7.19|||2-sided Van Elteren's test|||Week 12 LOCF||-7.19|-7.40|<0.0001
71865368|NCT00798434|143245958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0026|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions||Week 12 LOCF||-0.09|-0.40|0.0026
71865369|NCT00798434|143245959|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-9.52||||0.0012|TWO_SIDED|95.0|-9.52|-9.09|||2-sided Van Elteren's test|||Week 12 LOCF||-9.09|-9.52|0.0012
71865370|NCT00798434|143245960|SUPERIORITY_OR_OTHER||Hodges-Lehman estimate|0.0||||0.1005|TWO_SIDED|95.0|0.0|0.0||The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.|Van-Elteren's Test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF||0.00|0.00|0.1005
71865371|NCT00798434|143245961|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.0218|TWO_SIDED|95.0|0.0|0.0|||2-sided Van Elteren's test|||Week 12 LOCF||0.00|0.00|0.0218
71865372|NCT00798434|143245962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|0.81|<|0.0001|TWO_SIDED|95.0|-6.3|-3.1|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline||Week 12 LOCF||-3.10|-6.30|<0.0001
71865373|NCT00798434|143245963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.515||||0.1113|TWO_SIDED|95.0|0.909|2.528||Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.|Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||LOCF||2.528|0.909|0.1113
71865374|NCT00798434|143245964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11||0.023|TWO_SIDED|95.0|-0.47|-0.04|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours||Incontinence pads at Week 12 LOCF||-0.04|-0.47|0.0230
71682461|NCT01162122|142883169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Brisbane-high risk group)|1.35||||||95.0|1.13|1.61||||||||1.61|1.13|
71682462|NCT01162122|142883169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio(H3N2/Wisconsin-high risk group|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||||1.5|1.1|
71865375|NCT00798434|143245964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.0909|TWO_SIDED|95.0|-0.12|0.01|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours||Creams at Week 12 LOCF||0.01|-0.12|0.0909
71910871|NCT00270998|143342255|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910872|NCT00270998|143342255|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910873|NCT00270998|143342255|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910874|NCT00270998|143342256|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910875|NCT00270998|143342256|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910876|NCT00270998|143342256|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910877|NCT00270998|143342257|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910878|NCT00270998|143342257|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910879|NCT00270998|143342257|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910880|NCT00270998|143342258|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910881|NCT00270998|143342258|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910882|NCT00270998|143342258|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71682463|NCT01162122|142883169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was \>0.67.|GMT Ratio (B strain-high risk group)|1.11|||||TWO_SIDED|95.0|0.95|1.3||||||||1.3|0.95|
71910883|NCT00270998|143342259|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.03|||||||Regression, Logistic|||||||0.03
71910884|NCT00270998|143342259|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic|||||||0.048
71910885|NCT00270998|143342259|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910886|NCT00270998|143342260|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71682464|NCT01162122|142883170|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-overall)|1.49|||||TWO_SIDED|95.0|1.33|1.67||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.67|1.33|
71682465|NCT01162122|142883170|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-overall)|1.38|||||TWO_SIDED|95.0|1.25|1.52||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.52|1.25|
71682466|NCT01162122|142883170|SUPERIORITY_OR_OTHER||GMT ratio (B strain-overall)|1.09|||||TWO_SIDED|95.0|0.99|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.21|0.99|
71865376|NCT00798434|143245964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.2039|TWO_SIDED|95.0|-0.08|0.02|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours||Powder at Week 12 LOCF||0.02|-0.08|0.2039
71682467|NCT01162122|142883170|SUPERIORITY_OR_OTHER||GMT ratio (H3N2/Brisbane-high risk)|1.36|||||TWO_SIDED|95.0|1.15|1.61||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.61|1.15|
71865377|NCT00798434|143245965|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.096|||<|0.0001|TWO_SIDED|95.0|2.181|4.395|||Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||Week 12 LOCF||4.395|2.181|<0.0001
71865378|NCT00798434|143245968|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.506|||<|0.0001|TWO_SIDED|95.0|1.767|3.556||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPBC category||Week 12 LOCF||3.556|1.767|<0.0001
71865379|NCT00798434|143245972|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.916||||0.0009|TWO_SIDED|95.0|1.305|2.811||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPUS category||LOCF||2.811|1.305|0.0009
71865380|NCT00798434|143245974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.12|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|-9.65|-4.59|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score||Week 12 LOCF||-4.59|-9.65|<0.0001
71865381|NCT00798434|143245975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.48|STANDARD_ERROR_OF_MEAN|1.14|<|0.0001|TWO_SIDED|95.0|2.24|6.73|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.||Week 12 LOCF||6.73|2.24|<0.0001
71865382|NCT00798434|143245976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.44||0.0002|TWO_SIDED|95.0|2.57|8.22|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Coping Subscale at Week 12; LOCF||8.22|2.57|0.0002
71865383|NCT00798434|143245976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|1.29|<|0.0001|TWO_SIDED|95.0|2.84|7.93|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Concern Subscale at Week 12; LOCF||7.93|2.84|<0.0001
71865384|NCT00798434|143245976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.09|STANDARD_ERROR_OF_MEAN|1.38||0.0032|TWO_SIDED|95.0|1.38|6.81|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Sleep Subscale at Week 12; LOCF||6.81|1.38|0.0032
71865385|NCT00798434|143245976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.51|STANDARD_ERROR_OF_MEAN|1.03||0.0152|TWO_SIDED|95.0|0.49|4.53|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Social Subscale at Week 12; LOCF||4.53|0.49|0.0152
71865386|NCT00798434|143245977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.537|||<|0.001|TWO_SIDED|95.0|2.281|5.484||Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||5.484|2.281|<0.001
71865387|NCT00798434|143245978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|2.045|4.058||Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF||4.058|2.045|<0.0001
71865388|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.18|STANDARD_ERROR_OF_MEAN|4.12||0.3163|TWO_SIDED|95.0|-4.13|12.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||General Health Perception; LOCF||12.49|-4.13|0.3163
71865389|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|8.63||0.4698|TWO_SIDED|95.0|-23.7|11.11|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Incontinence Impact; LOCF||11.11|-23.70|0.4698
71910887|NCT00270998|143342260|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71865390|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|STANDARD_ERROR_OF_MEAN|9.28||0.5321|TWO_SIDED|95.0|-24.58|12.88|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Role Limitations; LOCF||12.88|-24.58|0.5321
71865391|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81|STANDARD_ERROR_OF_MEAN|8.39||0.6523|TWO_SIDED|95.0|-20.74|13.12|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Physical Limitations; LOCF||13.12|-20.74|0.6523
71865392|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|6.8||0.6344|TWO_SIDED|95.0|-10.47|16.99|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Social Limitations; LOCF||16.99|-10.47|0.6344
71865393|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|STANDARD_ERROR_OF_MEAN|8.38||0.2013|TWO_SIDED|95.0|-28.71|6.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Personal Relationships; LOCF||6.49|-28.71|0.2013
71865394|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.07|STANDARD_ERROR_OF_MEAN|6.88||0.3831|TWO_SIDED|95.0|-19.96|7.83|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Emotions; LOCF||7.83|-19.96|0.3831
71910888|NCT00270998|143342260|NON_INFERIORITY|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic|||||||<0.0492
71910889|NCT00763243|143342268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|2.17||0.766|TWO_SIDED|95.0|-1.44|1.89|||t-test, 2 sided|t(8)=0.31||Change during waiting period (no intervention); no change was hypothesized||1.89|-1.44|0.766
71682468|NCT01162122|142883170|SUPERIORITY_OR_OTHER||GMT ratio(H3N2/Wisconsin-high risk)|1.28|||||TWO_SIDED|95.0|1.1|1.48||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.48|1.1|
71682469|NCT01162122|142883170|SUPERIORITY_OR_OTHER||GMT ratio (B strain-high risk)|1.13|||||TWO_SIDED|95.0|0.97|1.31||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was \>1.5.||1.31|0.97|
71682470|NCT01162122|142883171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (H3N2/Brisbane-overall)|11.3|||||TWO_SIDED|95.0|6.7|15.9||||||||15.9|6.7|
71682471|NCT01162122|142883171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Wisconsin-overall)|11.9|||||TWO_SIDED|95.0|7.3|16.6||||||||16.6|7.3|
71682472|NCT01162122|142883171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Slope|4.0|||||TWO_SIDED|95.0|-0.4|8.4||||||||8.4|-0.4|
71682473|NCT01162122|142883171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Brisbane-high risk|12.3|||||TWO_SIDED|95.0|4.8|19.9||||||||19.9|4.8|
71682474|NCT01162122|142883171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference(H3N2Wisconsin-high risk|12.6|||||TWO_SIDED|95.0|5.0|20.2||||||||20.2|5.0|
71865395|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.46|STANDARD_ERROR_OF_MEAN|6.82||0.5167|TWO_SIDED|95.0|-9.3|18.23|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Sleep/Energy; LOCF||18.23|-9.30|0.5167
71865396|NCT00798434|143245979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.19|STANDARD_ERROR_OF_MEAN|5.12||0.0532|TWO_SIDED|95.0|-20.53|0.15|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Severity of Urinary Symptoms; LOCF||0.15|-20.53|0.0532
71865397|NCT00798434|143245980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0016|STANDARD_ERROR_OF_MEAN|0.0125||0.8959|TWO_SIDED|95.0|-0.0229|0.0262|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline single utility score||||0.0262|-0.0229|0.8959
71865398|NCT03898167|143245989|OTHER||Relative Participation|2.36|||||TWO_SIDED|95.0|1.99|2.8||95% CIs were calculated.||||Bivariable tables, Pearson chi-square and Kruskal-Wallis nonparametric tests were used to compare demographic/health care characteristics by study group. Log binomial regression was used to calculate screening proportion, participation difference, and relative participation (calculated as relative risk), with 95% CIs. Overall participation difference and relative participation for SC and SC with patient navigation vs TR were calculated by combining numerators and denominators from each group.||2.80|1.99|
71865399|NCT05292586|143245992|SUPERIORITY||Adjusted mean difference|0.104|||<|0.001|TWO_SIDED|95.0|0.061|0.148|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.148|0.061|<0.001
71865400|NCT05292586|143245993|SUPERIORITY||Adjusted mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.076|0.173|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.173|0.076|<0.001
71910890|NCT00763243|143342268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_DEVIATION|1.0|<|0.001|TWO_SIDED|95.0|0.9|2.44|||t-test, 2 sided|t(8)=5.0||Change during the training period||2.44|0.90|<0.001
71910891|NCT00763243|143342268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.78|STANDARD_DEVIATION|1.86||0.021|TWO_SIDED|95.0|0.35|3.2|||t-test, 2 sided|t(8)=2.87||Change from pre-training through follow-up period||3.20|0.35|0.021
71910892|NCT00763243|143342268|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|1.12||0.4|TWO_SIDED|95.0|-0.53|1.19|||t-test, 2 sided|t(8)=0.89||Change from pretraining to 6 month follow up||1.19|-0.53|0.40
71910893|NCT00763243|143342269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33|STANDARD_DEVIATION|2.24||0.11|TWO_SIDED|95.0|-0.39|3.05|||t-test, 2 sided|t(8)=1.79||Change during waiting period of no intervention||3.05|-0.39|0.11
71910894|NCT00763243|143342269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44|STANDARD_DEVIATION|1.81||0.004|TWO_SIDED|95.0|1.05|3.84|||t-test, 2 sided|t(8)=4.05||Change during training period||3.84|1.05|0.004
71910895|NCT00763243|143342269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.11|STANDARD_DEVIATION|3.06||0.072|TWO_SIDED|95.0|-0.24|4.46|||t-test, 2 sided|t(8)=2.07||1 Month Follow Up change from pre-training||4.46|-0.24|0.072
71910896|NCT00763243|143342269|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|2.28||0.34|TWO_SIDED|95.0|-0.97|2.53|||t-test, 2 sided|t(8)=1.02||6 month follow up change from pre-training||2.53|-0.97|0.34
71910897|NCT00763243|143342270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|1.86||0.729|TWO_SIDED|95.0|-1.2|1.65|||t-test, 2 sided|t(8)=0.36||Waiting period - no treatment||1.65|-1.20|0.729
71910898|NCT00763243|143342270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|2.17||0.039|TWO_SIDED|95.0|-3.44|-0.11|||t-test, 2 sided|t(8)=2.46||Training Period - Pretraining to Post-Training Visit||-0.11|-3.44|0.039
71910899|NCT00763243|143342270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_DEVIATION|2.98||0.4|TWO_SIDED|95.0|-3.17|1.4|||t-test, 2 sided|t(8)=0.90||1 Month Follow Up Period from Pretraining||1.40|-3.17|0.40
71910900|NCT00763243|143342270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|2.5||0.4|TWO_SIDED|95.0|-2.59|1.26|||t-test, 2 sided|t(8)=0.89||6 Month Follow Up period from pretraining||1.26|-2.59|0.40
71910901|NCT02157168|143342271|SUPERIORITY|||||||0.624||||||This comparison reflects intent to treat and is the main comparison in the study.|Chi-squared|||CG and IG (IG1+IG2)||||0.624
71682475|NCT01162122|142883171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (B strain-high risk)|4.8|||||TWO_SIDED|95.0|-2.1|11.8||||||||11.8|-2.1|
71910902|NCT02157168|143342271|SUPERIORITY|||||||0.001||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.001
71910903|NCT02157168|143342272|SUPERIORITY|||||||0.278||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.278
71910904|NCT02157168|143342272|SUPERIORITY|||||||0.056||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.056
71910905|NCT02157168|143342273|SUPERIORITY|||||||0.889||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.889
71910906|NCT02157168|143342273|SUPERIORITY|||||||0.691||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.691
71910907|NCT02157168|143342274|SUPERIORITY|||||||0.741||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)||||0.741
71682476|NCT01162122|142883172|SUPERIORITY_OR_OTHER||Group difference (H3N2/Brisbane-overall)|12.5|||||TWO_SIDED|95.0|8.1|16.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||16.9|8.1|
71865401|NCT05292586|143245994|SUPERIORITY||Adjusted mean difference|0.101|||<|0.001|TWO_SIDED|95.0|0.063|0.139|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.139|0.063|<0.001
71865402|NCT05292586|143245995|SUPERIORITY||Adjusted mean difference|0.113|||<|0.001|TWO_SIDED|95.0|0.071|0.154|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.154|0.071|<0.001
71865403|NCT05292586|143245996|SUPERIORITY||Adjusted mean difference|0.069||||0.003|TWO_SIDED|95.0|0.023|0.115|||ANCOVA|||"1\_Change from baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.115|0.023|0.003
71865404|NCT05292586|143245997|SUPERIORITY||Adjusted mean difference|0.044||||0.05|TWO_SIDED|95.0|0.0|0.088|||ANCOVA|||"1\_Change from baseline -- Week 4~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.088|0.000|0.050
71910908|NCT02157168|143342274|SUPERIORITY|||||||0.966||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared|||||||0.966
71910909|NCT02157168|143342275|SUPERIORITY|||||||0.117||||||This comparison captures the change over the intervention period.|Chi-squared|||||||.117
71910910|NCT02157168|143342275|SUPERIORITY|||||||0.638||||||This comparison is an indication of whether the change seen between baseline and 6 months in the IG1 was due to the intervention or simply due to 6 months' enrollment.|Chi-squared|||||||.638
71910911|NCT02781454|143342298|SUPERIORITY||linear contrast active vs placebo|-5.558||||0.039|TWO_SIDED|95.0|-10.8|-0.315|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||-0.315|-10.80|0.039
71682477|NCT01162122|142883172|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-overall)|12.6|||||TWO_SIDED|95.0|8.1|17.1||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||17.1|8.1|
71910912|NCT02781454|143342299|SUPERIORITY||linear contrast active vs placebo|0.792||||0.332|TWO_SIDED|95.0|0.484|1.296||linear contrast active vs placebo|Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.296|0.484|0.332
71910913|NCT02781454|143342300|SUPERIORITY||linear contrast active vs placebo|0.411||||0.013|TWO_SIDED|95.0|0.208|0.81|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||0.810|0.208|0.013
71910914|NCT02781454|143342301|SUPERIORITY||linear contrast active vs placebo|0.343||||0.986|TWO_SIDED|95.0|-41.36|42.042|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||42.042|-41.36|0.986
71910915|NCT02781454|143342302|SUPERIORITY||linear contrast active vs placebo|0.994||||0.915|TWO_SIDED|95.0|0.876|1.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0||1.126|0.876|0.915
71910916|NCT02781454|143342303|SUPERIORITY||linear contrast active vs placebo|1.089||||0.694|TWO_SIDED|95.0|-4.609|6.786|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||6.786|-4.609|0.694
71865405|NCT05292586|143245997|SUPERIORITY||Adjusted mean difference|0.041||||0.098|TWO_SIDED|95.0|-0.007|0.089|||ANCOVA|||"2\_Change from baseline -- Week 8~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.089|-0.007|0.098
71865406|NCT05292586|143245997|SUPERIORITY||Adjusted mean difference|0.043||||0.056|TWO_SIDED|95.0|-0.001|0.086|||ANCOVA|||"3\_Change from baseline -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.086|-0.001|0.056
71865407|NCT05292586|143245998|SUPERIORITY||Odds Ratio (OR)|1.327||||0.098|TWO_SIDED|95.0|0.949|1.855|||Logistic regression model|||1\_Responders at Week 4||1.855|0.949|0.098
71865408|NCT05292586|143245998|SUPERIORITY||Odds Ratio (OR)|1.262||||0.18|TWO_SIDED|95.0|0.898|1.772|||Logistic regression model|||2\_Responders at Week 8||1.772|0.898|0.180
71865409|NCT05292586|143245998|SUPERIORITY||Odds Ratio (OR)|1.568||||0.009|TWO_SIDED|95.0|1.117|2.203|||Logistic regression model|||3\_Responders at Week 12||2.203|1.117|0.009
71865410|NCT05292586|143245999|SUPERIORITY||Odds Ratio (OR)|1.822|||<|0.001|TWO_SIDED|95.0|1.284|2.587|||Logistic regression model|||1\_Responders at Week 12||2.587|1.284|<0.001
71865411|NCT05292586|143246000|SUPERIORITY||Adjusted mean difference|8.78||||0.002|TWO_SIDED|95.0|3.3|14.27|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.27|3.30|0.002
71865412|NCT05292586|143246001|SUPERIORITY||Adjusted mean difference|8.73||||0.002|TWO_SIDED|95.0|3.32|14.14|||ANCOVA|||"1\_Change From Baseline; Week 0 -- Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||14.14|3.32|0.002
71865413|NCT05292586|143246002|SUPERIORITY||Adjusted mean difference|-0.112||||0.026|TWO_SIDED|95.0|-0.211|-0.013|||ANCOVA|||"1\_Change From Baseline in ACQ-7 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||-0.013|-0.211|0.026
71865414|NCT05292586|143246002|SUPERIORITY||Adjusted mean difference|0.02||||0.686|TWO_SIDED|95.0|-0.077|0.118|||ANCOVA|||"2\_Change from baseline in ACQ-5 at Week 12~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||0.118|-0.077|0.686
71865415|NCT05292586|143246003|SUPERIORITY||Adjusted mean difference|3.82||||0.033|TWO_SIDED|95.0|0.31|7.33|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.330|0.310|0.033
71865416|NCT05292586|143246004|SUPERIORITY||Adjusted mean difference|3.78||||0.078|TWO_SIDED|95.0|-0.425|7.985|||ANCOVA|||"1\_Change From Baseline~Statistical analysis used all available data and imputed missing data (i.e., whether due to missed visits, unperformed or unevaluable assessments at intermediate timepoints, or early study discontinuation) in ITT population (overall population N=283 in CHF 1535 pMDI 800/24 μg study group; N=280 in the CHF 718 pMDI 800 μg study group)."||7.985|-0.425|0.078
71865417|NCT05177354|143246005|SUPERIORITY||Proportion|89.3|||<|0.001|ONE_SIDED|97.5|71.8|||"It is hypothesized that the proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Closed Loop On compared to Closed Loop Off period exceeds a performance goal of 50%.~H0: p ≤ 50% HA: p \> 50%"|Binomial Exact Test||||||71.8|<0.001
71865418|NCT03548220|143246014|SUPERIORITY||||||<|0.0001||||||2-sided p-value|Exact Cochran-Mantel-Haenszel|||||||<0.0001
71865419|NCT03548220|143246015|SUPERIORITY||LS Mean Difference|18.21|||<|0.0001|TWO_SIDED|95.0|12.41|24.01|||Mixed-effect Model Repeated Measure||Standard error = 2.913|||24.01|12.41|<0.0001
71865420|NCT03548220|143246018|SUPERIORITY||LS Mean Difference|-26.26|||<|0.0001|TWO_SIDED|95.0|-37.82|-14.7|||Mixed-effect Model Repeated Measure||Standard error = 5.788|||-14.70|-37.82|<0.0001
71865421|NCT03548220|143246019|SUPERIORITY||LS Mean Difference|-70.81||||0.0027|TWO_SIDED|95.0|-115.88|-25.74|||Mixed-effect Model Repeated Measure||Standard error = 22.488|||-25.74|-115.88|0.0027
71865422|NCT03548220|143246020|SUPERIORITY||LS Mean Difference|0.158||||0.0079|TWO_SIDED|95.0|0.043|0.273|||Mixed-effect Model Repeated Measure||Standard error = 0.0578|||0.273|0.043|0.0079
71865423|NCT03548220|143246021|SUPERIORITY||LS Mean Difference|-0.1011|||<|0.0001|TWO_SIDED|95.0|-0.1391|-0.0632|||Mixed-effect Model Repeated Measure||Standard error = 0.01904|||-0.0632|-0.1391|<0.0001
71865424|NCT03548220|143246022|SUPERIORITY||LS Mean Difference|-3.11||||0.0247|TWO_SIDED|95.0|-5.8|-0.41|||Mixed-effect Model Repeated Measure||Standard error = 1.352|||-0.41|-5.80|0.0247
71865425|NCT03548220|143246023|SUPERIORITY||LS Mean Difference|-3.25||||0.0421|TWO_SIDED|95.0|-6.39|-0.12|||Mixed-effect Model Repeated Measure||Standard error = 1.574|||-0.12|-6.39|0.0421
71865426|NCT03570892|143246034|SUPERIORITY||Unadjusted stratified cox model hazard r|1.07|||=|0.694|TWO_SIDED|95.0|0.82|1.4|||Stratified log-rank test one-sided|||||1.40|0.82|= 0.694
71865427|NCT00515671|143246094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8868|TWO_SIDED||||||Mixed Models Analysis|||||||.8868
71865428|NCT00515671|143246095|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3328|TWO_SIDED||||||Mixed Models Analysis|||||||.3328
71910917|NCT02781454|143342304|SUPERIORITY||linear contrast active vs placebo|0.242||||0.969|TWO_SIDED|95.0|-12.64|13.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||13.126|-12.64|0.969
71865429|NCT00288639|143246097|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.72|STANDARD_DEVIATION|55.232||||95.0|-34.16|-11.28|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-11.28|-34.16|
71865430|NCT00288639|143246098|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-17.26|STANDARD_DEVIATION|48.797||||95.0|-27.36|-7.15|||||Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-7.15|-27.36|
71910918|NCT02781454|143342305|SUPERIORITY||linear contrast active vs placebo|2.597||||0.323|TWO_SIDED|95.0|-2.772|7.966|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||7.966|-2.772|0.323
71910919|NCT02781454|143342306|SUPERIORITY||linear contrast active vs placebo|-2.017||||0.273|TWO_SIDED|95.0|-5.767|1.733|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.733|-5.767|0.273
71910920|NCT02781454|143342307|SUPERIORITY||linear contrast active vs placebo|0.708||||0.713|TWO_SIDED|95.0|0.111|4.535|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo||4.535|0.111|0.713
71910921|NCT02781454|143342309|SUPERIORITY||linear contrast active vs placebo|-0.399||||0.601|TWO_SIDED|95.0|-1.966|1.169|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||1.169|-1.966|0.601
71910922|NCT02781454|143342310|SUPERIORITY||linear contrast active vs placebo|-2.734||||0.285|TWO_SIDED|95.0|-7.938|2.471|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4||2.471|-7.938|0.285
71910923|NCT02372097|143342321|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed AUC(0-168) of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|Least square (LS) mean difference|-0.017|||||TWO_SIDED|90.0|-0.0344|0.0004||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-168) as a dependent variable, and product, group and period as fixed effects.||0.0004|-0.0344|
71910924|NCT02372097|143342322|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed Cmax of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|LS mean difference|-0.1292|||||TWO_SIDED|90.0|-0.2177|-0.0406||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the Cmax as a dependent variable, and product, group and period as fixed effects.||-0.0406|-0.2177|
71910925|NCT02372097|143342323|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.021||||||90.0|-0.0362|-0.0058||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-inf) as a dependent variable, and product, group and period as fixed effects.||-0.0058|-0.0362|
71910926|NCT02372097|143342324|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.375|||||TWO_SIDED|90.0|-0.1452|0.8952||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with Tmax as a dependent variable, and product, group and period as fixed effects.||0.8952|-0.1452|
71910927|NCT02372097|143342325|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.0168|||||TWO_SIDED|90.0|-0.0504|0.0169||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the MRT as a dependent variable, and product, group and period as fixed effects.||0.0169|-0.0504|
71910928|NCT02372097|143342326|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.1099|||||TWO_SIDED|90.0|0.0235|0.1963||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the λz as a dependent variable, and product, group and period as fixed effects.||0.1963|0.0235|
71910929|NCT01313208|143342340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.055|TWO_SIDED|95.0|0.99|3.41|||Mantel Haenszel|P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).|Etanercept/Placebo|||3.41|0.99|0.055
71682478|NCT01162122|142883172|SUPERIORITY_OR_OTHER||Group difference (B strain-overall)|4.6|||||TWO_SIDED|95.0|0.4|8.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||8.8|0.4|
71910930|NCT01957787|143342382|OTHER|||||||0.41||||||Estimates of the log odds and Wald standard error from a random effects logistic regression model were combined across imputed datasets for reference.|Random effects logistic regression model|||The null hypothesis was tested comparing the lower bound of the Wald 97.5% 1-sided confidence interval for the estimated rate of local tumor control to the performance goal of 84.0%. If the lower bound was greater than 84.0%, the null hypothesis was rejected and the endpoint was considered met.||||0.410
71910931|NCT03258632|143342394|SUPERIORITY||Odds Ratio (OR)|1.17|||<|0.05|TWO_SIDED|95.0|0.73|1.9|||Mixed Models Analysis|||||1.90|0.73|<.05
71865431|NCT00288639|143246099|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.43|STANDARD_DEVIATION|56.615||||95.0|-34.16|-10.71|||||1-28 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts.Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-10.71|-34.16|
71910932|NCT04046341|143342400|OTHER|||||||0.008||||||A priori statistical significance threshold = p\<.05|McNemar|||||||.008
71910933|NCT04046341|143342401|SUPERIORITY|||||||0.014||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.014
71910934|NCT04046341|143342402|SUPERIORITY|||||||0.013||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.013
71910935|NCT04046341|143342403|SUPERIORITY|||||||0.001||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.001
71910936|NCT04046341|143342404|SUPERIORITY|||||||0.209||||||A priori statistical significance threshold = p\<.05|t-test, 2 sided|||||||.209
71910937|NCT00004732|143342442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.81|1.51|||||HR (95% CI) adjusted for age, sex and symptomatic status|||1.51|0.81|
71910938|NCT00004732|143342443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.82|2.23|||||HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)|||2.23|0.82|
71910939|NCT01183312|143342444|SUPERIORITY_OR_OTHER|||||||0.77||95.0|||||wilcoxon signed rank (paired)|||||||0.77
71910940|NCT01183312|143342445|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.51
71910941|NCT01183312|143342446|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.32
71910942|NCT01183312|143342447|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.56
71910943|NCT01183312|143342448|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.14
71910944|NCT01183312|143342449|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.89
71910945|NCT01183312|143342450|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||Wilcoxon Signed Rank (paired)|||||||0.13
71910946|NCT00247273|143342539|NON_INFERIORITY_OR_EQUIVALENCE|In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.|Least Square (LS) Mean Difference|-0.115|||||TWO_SIDED|95.0|-0.505|0.274|||ANOVA|Fixed effects for treatment and pooled center||||0.274|-0.505|
71910947|NCT00247273|143342540|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.076|||||TWO_SIDED|95.0|-0.475|0.323|||ANOVA|Fixed effects for treatment and pooled center.||||0.323|-0.475|
71910948|NCT00247273|143342541|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0005|||||TWO_SIDED|95.0|-0.0035|0.0024|||ANOVA|Fixed effects for treatment and pooled center.||||0.0024|-0.0035|
71910949|NCT00247273|143342542|NON_INFERIORITY_OR_EQUIVALENCE|The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001).|LS Mean Difference|-0.239|||||TWO_SIDED|95.0|-0.727|0.249|||ANOVA|Fixed effects for treatment and pooled centers.||The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%.||0.249|-0.727|
71910950|NCT00247273|143342543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.085|||||TWO_SIDED|95.0|-0.609|0.439|||ANOVA|Fixed Effects for treatment \& pooled center||||0.439|-0.609|
71910951|NCT00247273|143342544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0009|||||TWO_SIDED|95.0|-0.0048|0.0029|||ANOVA|Fixed effects for treatment and pooled center.||||0.0029|-0.0048|
71910952|NCT00247273|143342545|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||||TWO_SIDED|95.0|-2.83|3.28|||ANOVA|Fixed effects for treatment and pooled center.||||3.28|-2.83|
71682479|NCT01162122|142883172|SUPERIORITY_OR_OTHER||Group difference(H3N2/Brisbane-high risk|12.4|||||TWO_SIDED|95.0|5.2|19.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||19.6|5.2|
71682480|NCT01162122|142883172|SUPERIORITY_OR_OTHER||Group difference(H3N2/Wisconsin-highrisk|13.0|||||TWO_SIDED|95.0|5.8|20.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||20.3|5.8|
71682481|NCT01162122|142883172|SUPERIORITY_OR_OTHER||Group difference (B strain-high risk)|5.1|||||TWO_SIDED|95.0|-1.6|11.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was \>10%.||11.8|-1.6|
71682482|NCT03313310|142883193|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.98||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.98
71682483|NCT03313310|142883193|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.05||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.05
71682484|NCT03313310|142883194|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.39||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.39
71682485|NCT03313310|142883194|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.76||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.76
71682486|NCT03313310|142883195|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.|||||<|0.001||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||<0.001
71865432|NCT00288639|143246099|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.83|STANDARD_DEVIATION|57.543||||95.0|-34.74|-10.91|||||29-56 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-10.91|-34.74|
71865433|NCT00288639|143246099|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-27.18|STANDARD_DEVIATION|59.323||||95.0|-39.9|-14.46|||||57-84 Days. Response ratio = 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. .|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-14.46|-39.90|
71865434|NCT00288639|143246099|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-30.75|STANDARD_DEVIATION|58.11||||95.0|-43.44|-18.06|||||85-112 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-18.06|-43.44|
71865435|NCT00288639|143246099|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-38.75|STANDARD_DEVIATION|59.368||||95.0|-51.79|-25.7|||||113-140 Days. Response ratio=100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-25.70|-51.79|
71865436|NCT00288639|143246099|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-44.24|STANDARD_DEVIATION|62.703||||95.0|-58.47|-30.01|||||\>140 Days. Response ratio= 100 x \[(t - b)/(t + b)\] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.||-30.01|-58.47|
71865437|NCT00288639|143246100|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|7.19|STANDARD_DEVIATION|84.425||||95.0|-17.6|31.98|||||Simple Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||31.98|-17.60|
71865438|NCT00288639|143246100|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-22.24|STANDARD_DEVIATION|68.058||||95.0|-37.8|-6.69|||||Complex Partial Seizures. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.69|-37.80|
71910953|NCT00247273|143342546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57|||||TWO_SIDED|95.0|-4.47|1.33|||ANOVA|Fixed effects for treatment and pooled center||||1.33|-4.47|
71910954|NCT00247273|143342547|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.54|4.53|||ANOVA|Fixed effects for treatment and pooled center||||4.53|-2.54|
71910955|NCT00247273|143342548|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83|||||TWO_SIDED|95.0|-6.45|0.8|||ANOVA|Fixed effects for treatment and pooled center.||||0.80|-6.45|
71865439|NCT00288639|143246100|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-23.85|STANDARD_DEVIATION|84.313||||95.0|-55.33|7.64|||||Evolved to Generalized. Response ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||7.64|-55.33|
71865440|NCT00288639|143246104|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-24.93|STANDARD_DEVIATION|60.867||||95.0|-43.66|-6.2|||||Seizure freq. ≤3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.20|-43.66|
71865441|NCT00288639|143246104|SUPERIORITY_OR_OTHER_LEGACY||Mean Response Ratio|-20.78|STANDARD_DEVIATION|50.334||||95.0|-35.24|-6.33|||||Seizure freq. \>3 / 28 d. Resp. ratio = 100 x \[(t - b)/(t + b)\] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.||-6.33|-35.24|
71865442|NCT02385240|143246124|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.034|||||TWO_SIDED|90.0|-7.52|10.72|||Wald's method|||||10.72|-7.52|
71865443|NCT02385240|143246125|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.05|||||TWO_SIDED|90.0|-6.94|11.33|||Wald's method|||||11.33|-6.94|
71865444|NCT02385240|143246126|EQUIVALENCE|provides 85% power of success|Equivalence ratio|1.26|||||TWO_SIDED|90.0|-1.77|15.46|||Wald's method|||||15.46|-1.77|
71865445|NCT01014208|143246127|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.333|TWO_SIDED|95.0|0.89|1.42||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-rank test||The Pike estimator was the statistical method used to estimate the hazard ratio.|||1.42|0.89|0.333
71865446|NCT01014208|143246128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4053|TWO_SIDED|95.0|0.56|1.24||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||1.24|0.56|0.4053
71865447|NCT01014208|143246128|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.1167|TWO_SIDED|95.0|0.39|1.1||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||1.10|0.39|0.1167
71865448|NCT01014208|143246129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.8209|TWO_SIDED|95.0|0.55|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR|||2.43|0.55|0.8209
71865449|NCT01014208|143246129|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6313|TWO_SIDED|95.0|0.62|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR|||2.43|0.62|0.6313
71865450|NCT01014208|143246130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.346|TWO_SIDED|95.0|0.9|1.36||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.36|0.90|0.346
71865451|NCT01014208|143246131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.377|TWO_SIDED|95.0|0.7|1.15||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.15|0.70|0.377
71910956|NCT00247273|143342549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.05|0.0|||ANOVA|Fixed effects for treatment and pooled center||||0.00|-0.05|
71682487|NCT03313310|142883195|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.02||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.02
71865452|NCT01014208|143246132|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.57||||0.1161|TWO_SIDED|95.0|0.83|9.5||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel|||||9.50|0.83|0.1161
71865453|NCT01014208|143246133|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4481|TWO_SIDED|95.0|0.56|1.27||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||Statistics are presented for Completion rate|||1.27|0.56|0.4481
71865454|NCT01014208|143246134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.978|TWO_SIDED|95.0|-2.11|2.17|||ANCOVA|||||2.170|-2.110|0.978
71865455|NCT01014208|143246135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.129||||0.387|TWO_SIDED|95.0|-1.434|3.691|||ANCOVA|||||3.691|-1.434|0.387
71865456|NCT01014208|143246136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.479|TWO_SIDED|95.0|0.74|1.16||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.16|0.74|0.479
71865457|NCT01014208|143246136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.059|TWO_SIDED|95.0|0.64|1.02||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.02|0.64|0.059
71910957|NCT00247273|143342550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-7.98|-0.36|||ANOVA|Fixed effects for treatment and pooled center||||-0.36|-7.98|
71910958|NCT00247273|143342551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.01|||ANOVA|Fixed effects for treatment and pooled center||||0.01|-0.06|
71910959|NCT00247273|143342552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.69|||||TWO_SIDED|95.0|-12.04|0.66|||ANOVA|Fixed effects for treatment and pooled center||||0.66|-12.04|
71910960|NCT00247273|143342553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-0.29|0.64|||ANOVA|Fixed effects for treatment and pooled center||||0.64|-0.29|
71910961|NCT00247273|143342554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31|||||TWO_SIDED|95.0|-0.85|3.48|||ANOVA|Fixed effects for treatment and pooled center||||3.48|-0.85|
71865458|NCT01014208|143246136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.451|TWO_SIDED|95.0|0.83|1.48||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.48|0.83|0.451
71865459|NCT01014208|143246136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.597|TWO_SIDED|95.0|0.86|1.29||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.29|0.86|0.597
71682488|NCT03313310|142883196|OTHER|A one-sample non-parametric test for change between baseline and 8-month follow-up was conducted.||||||0.51||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.51
71682489|NCT03313310|142883196|OTHER|A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted.||||||0.17||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|Wilcoxon Signed Rank|||||||0.17
71682490|NCT03313310|142883197|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71682491|NCT03313310|142883197|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71682492|NCT03313310|142883198|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71865460|NCT01014208|143246136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.199|TWO_SIDED|95.0|0.7|1.1||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.10|0.70|0.199
71682493|NCT03313310|142883198|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.5||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.50
71682494|NCT03313310|142883199|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.63||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.63
71865461|NCT01014208|143246136|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.102|TWO_SIDED|95.0|0.93|1.59||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||1.59|0.93|0.102
71865462|NCT01014208|143246137|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.035|TWO_SIDED|95.0|0.36|1.0||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio \<1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|||1.00|0.36|0.035
71865463|NCT00225017|143246149|NON_INFERIORITY_OR_EQUIVALENCE|25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%|Mean Difference (Net)|-0.384|STANDARD_DEVIATION|1.0||0.601|TWO_SIDED|95.0|-2.08|1.312|||Wilcoxon (Mann-Whitney)|||||1.312|-2.080|0.601
71865464|NCT00225017|143246150|SUPERIORITY_OR_OTHER||||||<|0.009||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.009
71865465|NCT00225017|143246151|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.141
71865466|NCT04020185|143246196|OTHER||maximum tolerated dose (monotherapy)|1200.0|||||TWO_SIDED|||||||||||||
71865467|NCT03433677|143246203|SUPERIORITY||Median Difference (Final Values)|0.0||||0.375|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon signed-rank test|||||0.00|0.00|0.375
71865468|NCT03433677|143246204|SUPERIORITY|||||||0.468|||||||Prescott's Exact test|||||||0.468
71865469|NCT03433677|143246205|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71865470|NCT03433677|143246206|SUPERIORITY||LSMean Difference|-1.8||||0.304|TWO_SIDED|95.0|-5.3|1.7|||Mixed Models Analysis|||||1.7|-5.3|0.304
71865471|NCT03433677|143246207|SUPERIORITY||LSMean Difference|-2.4||||0.057|TWO_SIDED|95.0|-4.8|0.1|||Mixed Models Analysis|||||0.1|-4.8|0.057
71865472|NCT03433677|143246208|SUPERIORITY||LSMeans|0.11||||0.177|TWO_SIDED|95.0|-0.05|0.27|||Mixed Models Analysis||LSMean Difference|||0.27|-0.05|0.177
71865473|NCT02175641|143246293|OTHER|Generalized linear mixed-effects models with a logistic link|Odds Ratio (OR)|1.07|||>|0.05|TWO_SIDED|95.0|0.62|1.84|||Regression, Logistic|||||1.84|0.62|>0.05
71865474|NCT02175641|143246294|OTHER|Mixed effect models controlling for study site.|Time by treatment interaction coefficien|0.15|STANDARD_ERROR_OF_MEAN|0.59||0.804|TWO_SIDED||||||Mixed Models Analysis|||||||0.804
71865475|NCT02175641|143246295|OTHER||Time*treatment interaction coefficient|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.91|TWO_SIDED||||||Mixed Models Analysis|||||||0.91
71865476|NCT02175641|143246296|OTHER|Mixed effect models controlling for study site.|time*treatment interaction coefficient|-0.34|STANDARD_ERROR_OF_MEAN|0.74||0.64|TWO_SIDED||||||Mixed Models Analysis|||||||0.64
71865477|NCT02175641|143246297|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.08|STANDARD_ERROR_OF_MEAN|0.09||0.38|TWO_SIDED||||||Mixed Models Analysis|||||||0.38
71865478|NCT02175641|143246298|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.39|TWO_SIDED||||||Mixed Models Analysis|||||||0.39
71865479|NCT02175641|143246299|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|0.23|STANDARD_ERROR_OF_MEAN|0.37||0.52|TWO_SIDED||||||Mixed Models Analysis|||||||0.52
71865480|NCT02175641|143246300|OTHER|Mixed effect models controlling for study site.|Time*treatment interaction coefficient|3.83|STANDARD_ERROR_OF_MEAN|3.28||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71682495|NCT03313310|142883199|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71865481|NCT03921723|143246302|EQUIVALENCE|Bioequivalence is established when the 90 percent (%) confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
71865482|NCT03921723|143246302|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to t) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.12|||||TWO_SIDED|90.0|1.05|1.2||||||||1.20|1.05|
71865483|NCT03921723|143246321|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
71865484|NCT03921723|143246321|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for AUC (0 to inf) between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.13||||||90.0|1.06|1.2||||||||1.20|1.06|
71682496|NCT03313310|142883200|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71910962|NCT00247273|143342555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.45|0.7|||ANOVA|Fixed effects for treatment and pooled center||||0.70|-0.45|
71682497|NCT03313310|142883200|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.25||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.25
71865485|NCT03921723|143246322|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype A versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.09|||||TWO_SIDED|90.0|1.01|1.19||||||||1.19|1.01|
71865486|NCT03921723|143246322|EQUIVALENCE|Bioequivalence is established when the 90% confidence interval of the ratio for Cmax between treatment formulations (Prototype B versus DTG Reference Treatment) are within the range of 0.80 to 1.25|Ratio|1.22|||||TWO_SIDED|90.0|1.13|1.33||||||||1.33|1.13|
71865487|NCT03733314|143246346|SUPERIORITY||Difference|10.3|||||TWO_SIDED|95.0|-24.9|45.4|||||The difference of percentage was calculated as E6011 minus placebo.|||45.4|-24.9|
71865488|NCT03733314|143246351|SUPERIORITY||Difference|-7.1|||||TWO_SIDED|95.0|-32.1|18.0|||||The difference of percentage was calculated as E6011 minus placebo.|||18.0|-32.1|
71865489|NCT03733314|143246352|SUPERIORITY||Difference|8.3|||||TWO_SIDED|95.0|-7.3|24.0|||||The difference of percentage was calculated as E6011 minus placebo.|||24.0|-7.3|
71865490|NCT01240915|143246363|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.223||0.96|TWO_SIDED|80.0|0.12|0.69||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||0.69|0.12|0.96
71865491|NCT01240915|143246364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.161||0.54|TWO_SIDED|80.0|-0.19|0.22||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 4)||0.22|-0.19|0.54
71865492|NCT01240915|143246365|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.174||0.67|TWO_SIDED|80.0|-0.15|0.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 8)||0.30|-0.15|0.67
71865493|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.02||||0.53|TWO_SIDED|80.0|0.73|1.42||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.42|0.73|0.53
71865494|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.48||||0.91|TWO_SIDED|80.0|1.02|2.14||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||2.14|1.02|0.91
71865495|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.38||||0.81|TWO_SIDED|80.0|0.86|2.23||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.23|0.86|0.81
71865496|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.94||||0.44|TWO_SIDED|80.0|0.59|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.51|0.59|0.44
71865497|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.18||||0.67|TWO_SIDED|80.0|0.72|1.94||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.94|0.72|0.67
71865498|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.12||||0.62|TWO_SIDED|80.0|0.68|1.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||1.84|0.68|0.62
71865499|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.95||||0.95|TWO_SIDED|80.0|0.58|1.57||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.57|0.58|0.95
71865500|NCT01240915|143246372|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.81||||0.3|TWO_SIDED|80.0|0.49|1.36||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.36|0.49|0.30
71865501|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.17||||0.79|TWO_SIDED|80.0|0.91|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||1.51|0.91|0.79
71865502|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.21||||0.8|TWO_SIDED|80.0|0.9|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||1.63|0.90|0.80
71865503|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.75||||0.99|TWO_SIDED|80.0|1.63|4.64||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||4.64|1.63|0.99
71865504|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.96||||0.96|TWO_SIDED|80.0|1.19|3.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.25|1.19|0.96
71865505|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.98||||0.95|TWO_SIDED|80.0|1.15|3.41||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||3.41|1.15|0.95
71865506|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|2.3||||0.99|TWO_SIDED|80.0|1.52|3.48||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||3.48|1.52|0.99
71865507|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.1||||0.62|TWO_SIDED|80.0|0.74|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.63|0.74|0.62
71865508|NCT01240915|143246373|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.51||||0.89|TWO_SIDED|80.0|0.98|2.32||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||2.32|0.98|0.89
71910963|NCT00247273|143342556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-3.96|2.43|||ANOVA|Fixed effects for treatment and pooled center||||2.43|-3.96|
71910964|NCT00247273|143342557|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||1|TWO_SIDED|95.0|0.36|2.54|||Fisher Exact|||||2.54|0.36|1.0000
71910965|NCT00247273|143342558|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98||||1|TWO_SIDED|95.0|0.47|2.03|||Fisher Exact|||||2.03|0.47|1.0000
71910966|NCT00607919|143342567|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71910967|NCT02007252|143342658|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.1037|||||||ANCOVA|||Month 3||||= 0.1037
71910968|NCT02007252|143342658|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.4806|||||||ANCOVA|||Month 12||||= 0.4806
71910969|NCT01628393|143342659|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71910970|NCT01628393|143342659|SUPERIORITY||||||<|0.0001||||||To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71910971|NCT01628393|143342660|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71910972|NCT01628393|143342660|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71910973|NCT01628393|143342661|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71910974|NCT01628393|143342661|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.||||||<0.0001
71910975|NCT01628393|143342662|SUPERIORITY||Rate Ratio|0.47||||0.0531|TWO_SIDED|95.0|0.22|1.01|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.01|0.22|0.0531
71910976|NCT01628393|143342662|SUPERIORITY||Rate Ratio|0.69||||0.2714|TWO_SIDED|95.0|0.36|1.34|||Poisson regression model|Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.|Rate ratio = Ozanimod / Placebo|||1.34|0.36|0.2714
71910977|NCT02001688|143342667|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|||||||0.0005
71910978|NCT02001688|143342667|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.020
71910979|NCT02001688|143342667|SUPERIORITY|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0192
71910980|NCT02001688|143342668|SUPERIORITY|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|p-value of Stratified Wilcoxon test||||||0.0005
71910981|NCT02001688|143342668|SUPERIORITY|||||||0.0193|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.0193
71910982|NCT02001688|143342668|SUPERIORITY|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance||||||0.2485
71910983|NCT02001688|143342669|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg,Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
71910984|NCT02001688|143342670|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg, Kamada-AAT for Inhalation, 160mg and placebo)||||||<0.0001
71910985|NCT05441540|143342678|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71910986|NCT05441540|143342679|OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71910987|NCT05441540|143342680|OTHER|||||||0.7613|||||||Kruskal-Wallis|||||||0.7613
71910988|NCT05441540|143342681|OTHER|||||||0.764|||||||Wilcoxon (Mann-Whitney)|||||||0.7640
71910989|NCT00813917|143342682|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.|Chi-squared|1 sided||Data were compared between treatment groups using Chi Square test.||||0.126
71910990|NCT00792701|143342705|OTHER|Correlation|Correlation Coefficient|0.39||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71910991|NCT00792701|143342708|SUPERIORITY_OR_OTHER_LEGACY||Correlation Coefficient|0.39||||0.0003|TWO_SIDED||||||Chi-squared|||Comparing RRM1 levels and ERCC1 levels between all patients.||||.0003
71910992|NCT00563368|143342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|0.831||0.0009|TWO_SIDED|95.0|1.13|4.39||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.39|1.13|0.0009
71910993|NCT00563368|143342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.15|STANDARD_ERROR_OF_MEAN|0.825||0.0001|TWO_SIDED|95.0|1.53|4.77||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.77|1.53|0.0001
71910994|NCT00563368|143342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|0.83|<|0.0001|TWO_SIDED|95.0|5.86|9.12||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||9.12|5.86|<0.0001
71910995|NCT00563368|143342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|STANDARD_ERROR_OF_MEAN|0.832|<|0.0001|TWO_SIDED|95.0|1.69|4.96||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.96|1.69|<0.0001
71910996|NCT00563368|143342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.01|STANDARD_ERROR_OF_MEAN|0.828||0.0003|TWO_SIDED|95.0|1.38|4.63||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.63|1.38|0.0003
71910997|NCT00563368|143342734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.75|STANDARD_ERROR_OF_MEAN|0.831|<|0.0001|TWO_SIDED|95.0|5.11|8.38||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||8.38|5.11|<0.0001
71910998|NCT00563368|143342735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.028|STANDARD_ERROR_OF_MEAN|0.5832||0.014|TWO_SIDED|95.0|1.154|3.563||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.563|1.154|0.0140
71910999|NCT00563368|143342735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.246|STANDARD_ERROR_OF_MEAN|0.6418||0.0046|TWO_SIDED|95.0|1.283|3.932||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.932|1.283|0.0046
71911000|NCT00563368|143342735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.623|STANDARD_ERROR_OF_MEAN|3.644|<|0.0001|TWO_SIDED|95.0|5.424|20.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||20.81|5.424|<0.0001
71911001|NCT00563368|143342735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.568|STANDARD_ERROR_OF_MEAN|0.7391||0.0011|TWO_SIDED|95.0|1.46|4.514||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||4.514|1.460|0.0011
71911002|NCT00563368|143342735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.166|STANDARD_ERROR_OF_MEAN|0.6158||0.0066|TWO_SIDED|95.0|1.241|3.781||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||3.781|1.241|0.0066
71911003|NCT00563368|143342735|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.063|STANDARD_ERROR_OF_MEAN|3.0857|<|0.0001|TWO_SIDED|95.0|4.65|17.66||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.||17.66|4.650|<0.0001
71911004|NCT00879437|143342736|NON_INFERIORITY|if 19 evaluable patients enrolled for DIPG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control if 21 evaluable patients enrolled for HGG, study is powered at 80% to detect a 20% improvement in 1-year EFS compared to historical control|||||<|0.05|||||||Log Rank|one sample log-rank||comparing 1-year EFS of DIPG on this trial versus historical control (1-year EFS of 17% from CCG-9941; PMID 12177103) comparing 1-year EFS of HGG on this trial versus historical control (1-year EFS of 36% from ACNS0126; PMID 21339192)||||< 0.05
71911005|NCT00879437|143342776|OTHER|The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the median EFS for each cohort with 95% confidence intervals.|||
71911006|NCT00879437|143342777|OTHER|The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals. All analyses were performed in SAS version 9.4 statistical software (SAS Institute Inc) and R (https://cran.r-project.org/).|||||||TWO_SIDED|95.0|||||||||The Kaplan-Meier method was used to estimate the one-year EFS for each cohort with 95% confidence intervals.|||
71911007|NCT00879437|143342778|OTHER|||||||||||||||||partial response defined as 51% to 99% reduction in tumor size,determined using WHO bi-dimensional criteria (product of the greatest tumor diameter and its perpendicular diameter)|Not applicable (8 partial responses in 16 patients = 50%)|||
71911008|NCT01112982|143342781|OTHER|||||||0.34|||||||t-test, 2 sided|||Presence of synovial pannus and the serum urate level.||||0.34
71911009|NCT01112982|143342783|OTHER|Spearman Correlation Coefficient||||||0.73|||||||t-test, 1 sided|||The Severity of Synovial Pannus and the Serum Urate level.||||0.73
71911010|NCT01112982|143342784|OTHER|correlation between severity of synovial pannus and the serum urate level.||||||0.73|||||||t-test, 1 sided|||||||0.73
71911011|NCT01112982|143342785|OTHER|||||||0.32||||||"The presence of synovial pannus in the index joint."|t-test, 1 sided|||||||0.32
71911012|NCT01112982|143342786|OTHER|Kappa Coefficient||||||0.09|||||||t-test, 2 sided|||The absence of erosive changes.||||0.09
71911013|NCT01112982|143342786|OTHER|the absence of Intraosseous Tophi.||||||0.33|||||||t-test, 2 sided|||||||0.33
71911014|NCT01112982|143342786|OTHER|The absence of Soft Tissue Tophi||||||0.09|||||||t-test, 2 sided|||||||0.09
71911015|NCT01112982|143342786|OTHER|The absence of Joint Effusion.||||||0.31|||||||t-test, 2 sided|||||||0.31
71911016|NCT01112982|143342786|OTHER|The absence of Bone Marrow Edema.||||||0.25|||||||t-test, 2 sided|||||||0.25
71911017|NCT01112982|143342786|OTHER|The absence of Soft Tissue Edema.||||||0.14|||||||t-test, 2 sided|||||||0.14
71911018|NCT01112982|143342787|OTHER|||||||0.32||||||"The Presence of synovial Pannus in the index joint."|t-test, 1 sided|||||||0.32
71911019|NCT01112982|143342787|OTHER|||||||0.99||||||"The Severity of Synovial Pannus in the index joint."|t-test, 1 sided|||||||0.99
71865509|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.34|TWO_SIDED|80.0|0.66|2.19||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||2.19|0.66|0.34
71865510|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.33|TWO_SIDED|80.0|0.68|2.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||2.23|0.68|0.33
71865511|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37||||0.1|TWO_SIDED|80.0|0.99|5.67||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||5.67|0.99|0.10
71865512|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.74|TWO_SIDED|80.0|0.28|1.55||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.55|0.28|0.74
71865513|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.48|TWO_SIDED|80.0|0.41|2.64||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||2.64|0.41|0.48
71865514|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.58|TWO_SIDED|80.0|0.38|2.03||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.03|0.38|0.58
71865515|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.68|TWO_SIDED|80.0|0.33|1.66||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.66|0.33|0.68
71865516|NCT01240915|143246374|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.84|TWO_SIDED|80.0|0.21|1.23||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.23|0.21|0.84
71865517|NCT01240915|143246375|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.57|TWO_SIDED|80.0|0.22|3.07||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||3.07|0.22|0.57
71865518|NCT01240915|143246376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39||||0.85|TWO_SIDED|80.0|0.12|1.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.23|0.12|0.85
71865519|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27||||0.05|TWO_SIDED|80.0|1.21|4.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)||4.24|1.21|0.05
71865520|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.43|TWO_SIDED|80.0|0.61|1.95||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)||1.95|0.61|0.43
71865521|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.44|TWO_SIDED|80.0|0.45|2.76||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)||2.76|0.45|0.44
71865522|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.38|TWO_SIDED|80.0|0.5|3.04||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)||3.04|0.50|0.38
71865523|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38||||0.89|TWO_SIDED|80.0|0.14|1.04||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.04|0.14|0.89
71865524|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.47|TWO_SIDED|80.0|0.45|2.42||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.42|0.45|0.47
71865525|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.24|TWO_SIDED|80.0|0.7|3.57||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)||3.57|0.70|0.24
71865526|NCT01240915|143246377|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.81|TWO_SIDED|80.0|0.22|1.32||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.32|0.22|0.81
71865527|NCT01240915|143246378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.84|TWO_SIDED|80.0|0.2|1.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||1.24|0.20|0.84
71865528|NCT01240915|143246379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.96|TWO_SIDED|80.0|0.12|0.73||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo||0.73|0.12|0.96
71865529|NCT01240915|143246380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.513||0.87|TWO_SIDED|80.0|-0.08|1.24||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.24|-0.08|0.87
71865530|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.345||0.8|TWO_SIDED|80.0|-0.15|0.74||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.74|-0.15|0.80
71911020|NCT01001234|143342804|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.025|TWO_SIDED|95.0|1.06|2.26||The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.|Regression, Logistic|Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.||The comparison of rizatriptan versus placebo with respect to the primary outcome was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (United States \[US\] or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.26|1.06|0.025
71922205|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-2.58|STANDARD_ERROR_OF_MEAN|2.49|||TWO_SIDED|95.0|-7.76|2.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||2.59|-7.76|
71865531|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.418||0.77|TWO_SIDED|80.0|-0.23|0.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.84|-0.23|0.77
71865532|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.666||0.74|TWO_SIDED|80.0|-0.42|1.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||1.30|-0.42|0.74
71865533|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.645||0.88|TWO_SIDED|80.0|-0.08|1.59||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||1.59|-0.08|0.88
71865534|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.705||0.72|TWO_SIDED|80.0|-0.5|1.33||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||1.33|-0.50|0.72
71865535|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21|STANDARD_ERROR_OF_MEAN|0.656||0.97|TWO_SIDED|80.0|0.37|2.06||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||2.06|0.37|0.97
71682498|NCT03313310|142883201|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71682499|NCT03313310|142883201|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71682500|NCT03313310|142883202|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 8-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71682501|NCT03313310|142883202|OTHER||||||||||||||||||A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts.|||
71865536|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.635||0.75|TWO_SIDED|80.0|-0.39|1.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||1.25|-0.39|0.75
71865537|NCT01240915|143246381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.692||0.85|TWO_SIDED|80.0|-0.16|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||1.63|-0.16|0.85
71865538|NCT01240915|143246382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.753||0.75|TWO_SIDED|80.0|-0.46|1.49||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo||1.49|-0.46|0.75
71865539|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.144||0.51|TWO_SIDED|80.0|-0.18|0.19||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)||0.19|-0.18|0.51
71865540|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.158||0.62|TWO_SIDED|80.0|-0.16|0.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)||0.25|-0.16|0.62
71865541|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.213||0.29|TWO_SIDED|80.0|-0.39|0.16||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)||0.16|-0.39|0.29
71865542|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.209||0.74|TWO_SIDED|80.0|-0.14|0.4||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)||0.40|-0.14|0.74
71865543|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.226||0.36|TWO_SIDED|80.0|-0.37|0.21||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)||0.21|-0.37|0.36
71865544|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.234||0.56|TWO_SIDED|80.0|-0.26|0.34||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)||0.34|-0.26|0.56
71682502|NCT03313310|142883204|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71682503|NCT03313310|142883204|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71682504|NCT03313310|142883205|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71682505|NCT03313310|142883205|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.75||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.75
71865545|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.231||0.18|TWO_SIDED|80.0|-0.51|0.09||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)||0.09|-0.51|0.18
71865546|NCT01240915|143246383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.31|TWO_SIDED|80.0|-0.45|0.2||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)||0.20|-0.45|0.31
71865547|NCT02574845|143246386|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.95|||||TWO_SIDED|90.0|89.49|116.15|||ANOVA|Analysis of variance (ANOVA) model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||116.15|89.49|
71865548|NCT02574845|143246386|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.09|||||TWO_SIDED|90.0|96.12|117.11|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.11|96.12|
71865549|NCT02574845|143246386|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|152.18|||||TWO_SIDED|90.0|135.12|171.41|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||171.41|135.12|
71922206|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-4.06|STANDARD_ERROR_OF_MEAN|2.53|||TWO_SIDED|95.0|-9.32|1.19|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||1.19|-9.32|
71922207|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-3.86|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-9.51|1.8|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||1.80|-9.51|
71865550|NCT02574845|143246386|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.97|||||TWO_SIDED|90.0|94.34|121.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.30|94.34|
71865551|NCT02574845|143246386|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|115.92|||||TWO_SIDED|90.0|101.93|131.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||131.82|101.93|
71911021|NCT01001234|143342805|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|95.0|0.96|1.9||Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.|Regression, Logistic|This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 12 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.90|0.96|0.080
71911022|NCT01001234|143342806|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.52||||0.01|TWO_SIDED|95.0|1.1|2.1||This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain freedom at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||2.10|1.10|0.010
71911023|NCT01001234|143342807|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.178|TWO_SIDED|95.0|0.91|1.63||This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio \>1 is in favor of the rizatriptan group.||1.63|0.91|0.178
71911024|NCT00753623|143342810|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71911025|NCT03332303|143342811|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Responders in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-5.1|||||TWO_SIDED|90.0|-13.0|2.8||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||2.8|-13.0|
71911026|NCT03332303|143342811|SUPERIORITY||% Difference|23.4|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
71911027|NCT03332303|143342811|SUPERIORITY||% Difference|28.7|||<|0.0001|TWO_SIDED|||||The a priori threshold for statistical significance is p \< 0.05.|Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the primary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||<0.0001
71911028|NCT03332303|143342812|EQUIVALENCE|If the 90% confidence interval (calculated using Yates' continuity correction) on the absolute difference between the proportion of patients identified as Treatment Successes in the Test and Reference groups (pT - pR) is contained within the range \[-20%, +20%\] then therapeutic equivalence of the Test product to the Reference product was considered to have been demonstrated.|Mean Difference (Final Values)|-2.0|||||TWO_SIDED|90.0|-10.7|6.7||||||Therapeutic equivalence was evaluated for both primary and secondary endpoints in the per-protocol (PP) population.||6.7|-10.7|
71911029|NCT03332303|143342812|SUPERIORITY|To conclude superiority of the Test product over Placebo, the proportion of Treatment Successes in the Test product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|-0.8||||0.8068|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8068
71911030|NCT03332303|143342812|SUPERIORITY|To conclude superiority of the Reference product over Placebo, the proportion of Treatment Successes in the Reference product group must be numerically and statistically superior to that of the Placebo (p \< 0.05; using a two-sided Cochran-Mantel-Haenszel \[CMH\] test).|% Difference|1.8||||0.8003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Superiority of the Test and Reference products against the Placebo product for the secondary endpoint was evaluated in the modified Intent-to-Treat (mITT) population using last observation carried forward (LOCF).||||0.8003
71682506|NCT03313310|142883206|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.55||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.55
71682507|NCT03313310|142883206|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||1||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||1.00
71682508|NCT03313310|142883207|OTHER|A one-sample test for change between baseline and 8-month follow-up was conducted.||||||0.45||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.45
71682509|NCT03313310|142883207|OTHER|A one-sample test for change between baseline and 3-month follow-up was conducted.||||||0.07||||||The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons.|McNemar|||||||0.07
71682510|NCT03434249|142883236|OTHER|||||||0.0001|||||||Chi-squared|||"According to the results of a previous trial that looked at a probiotic's effect on infants with CI, it was estimated that when the sample size in each group is 33, the study has 80% power to detect an absolute difference of 35% in the treatment success rate (15% in the Placebo group and 50% in the treatment group) with a 0,05 alpha level.~The number of infants that was included in the study was 80, with an expected maximum dropout rate of 20%."||||0.0001
71682511|NCT03434249|142883237|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71682512|NCT03434249|142883239|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71682513|NCT00561470|142883250|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.817||||0.0032|TWO_SIDED|95.34|0.713|0.937||Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|||0.937|0.713|0.0032
71865552|NCT02574845|143246387|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|102.47|||||TWO_SIDED|90.0|87.19|120.42|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||120.42|87.19|
71865553|NCT02574845|143246387|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|106.98|||||TWO_SIDED|90.0|92.54|123.69|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||123.69|92.54|
71865554|NCT02574845|143246387|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|154.07|||||TWO_SIDED|90.0|131.7|180.24|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||180.24|131.70|
71865555|NCT02574845|143246387|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|106.81|||||TWO_SIDED|90.0|91.78|124.3|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||124.30|91.78|
71865556|NCT02574845|143246387|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|117.98|||||TWO_SIDED|90.0|98.27|141.65|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||141.65|98.27|
71682514|NCT00561470|142883251|SUPERIORITY_OR_OTHER||Stratified Hazard ratio|0.758||||7e-05|TWO_SIDED|99.99|0.578|0.995||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.|||0.995|0.578|0.00007
71682515|NCT00561470|142883252|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Stratified Cochran-Mantel-Haenszel|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||||||0.0001
71682516|NCT01592292|142883280|SUPERIORITY_OR_OTHER|||||||0.3037||||||Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.|ANCOVA|||||||0.3037
71682517|NCT01592292|142883281|SUPERIORITY_OR_OTHER|||||||0.0951||||||Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.0951
71682518|NCT01592292|142883282|SUPERIORITY_OR_OTHER|||||||0.239||||||Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA|||||||0.2390
71682519|NCT01592292|142883283|SUPERIORITY_OR_OTHER|||||||0.3212||||||Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3212
71682520|NCT01592292|142883283|SUPERIORITY_OR_OTHER|||||||0.7097||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7097
71682521|NCT01592292|142883284|SUPERIORITY_OR_OTHER|||||||0.2444||||||Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2444
71682522|NCT01592292|142883284|SUPERIORITY_OR_OTHER|||||||0.3903||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.3903
71682523|NCT01592292|142883285|SUPERIORITY_OR_OTHER|||||||0.5306||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5306
71682524|NCT01592292|142883285|SUPERIORITY_OR_OTHER|||||||0.2542||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2542
71865557|NCT02574845|143246388|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T1/REF (%)|101.22|||||TWO_SIDED|90.0|89.23|114.82|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||114.82|89.23|
71865558|NCT02574845|143246388|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T2/REF (%)|107.26|||||TWO_SIDED|90.0|97.65|117.81|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||117.81|97.65|
71865559|NCT02574845|143246388|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T3/REF (%)|146.45|||||TWO_SIDED|90.0|135.21|158.62|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.||158.62|135.21|
71865560|NCT02574845|143246388|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T4/REF (%)|105.63|||||TWO_SIDED|90.0|92.2|121.0|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.||121.00|92.20|
71865561|NCT02574845|143246388|SUPERIORITY_OR_OTHER_LEGACY||Adjusted geometric mean ratio T5/REF (%)|118.1|||||TWO_SIDED|90.0|106.75|130.67|||ANOVA|ANOVA model on the logarithmic scale including the effects: 'sequence', 'subjects within sequence', 'period' and 'treatment'.||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.||130.67|106.75|
71865562|NCT04091061|143246400|OTHER|90% Confidence Intervals (CIs) for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.99|||||TWO_SIDED|90.0|83.14|296.44|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference.|||296.44|83.14|
71865563|NCT04091061|143246400|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|125.58|||||TWO_SIDED|90.0|66.51|237.13|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||237.13|66.51|
71865564|NCT04091061|143246400|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|123.75|||||TWO_SIDED|90.0|65.54|233.68|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||233.68|65.54|
71865565|NCT04091061|143246401|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.25|||||TWO_SIDED|90.0|81.07|301.16|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||301.16|81.07|
71865566|NCT04091061|143246401|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.66|||||TWO_SIDED|90.0|85.95|319.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||319.29|85.95|
71865567|NCT04091061|143246401|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.18|||||TWO_SIDED|90.0|78.96|293.32|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.32|78.96|
71865568|NCT04091061|143246402|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|156.0|||||TWO_SIDED|90.0|80.95|300.6|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 1: Mild Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||300.60|80.95|
71865569|NCT04091061|143246402|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|165.38|||||TWO_SIDED|90.0|85.82|318.67|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 2: Moderate Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||318.67|85.82|
71865570|NCT04091061|143246402|OTHER|90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|Ratio (%)|152.2|||||TWO_SIDED|90.0|78.99|293.29|||||90% CIs for the ratios of adjusted geometric means (Test/Reference): Analysis 3: Severe Hepatic Impairment = Test, Without Hepatic Impairment = Reference|||293.29|78.99|
71865571|NCT00821587|143246407|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|95.0||||We hypothesize that subjects on CsA are more likely to achieve undetectable viral level in patients receiving antiviral therapy for recurrent HCV after Liver Transplant|Chi-squared|||We hypothesize that subjects on CsA are more likely to achieve undetectable viral levels after liver transplant. Comparisons between the two groups (Undetectable viral level vs. Detectable viral level) were performed with Pearson Chi-square tests or Fisher's exact test for categorical variables, and Mann-Whitney U test for continuous variables.||||<0.05
71882534|NCT02054897|143284140|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.|Treatment difference|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.25|||Mixed Models Analysis||Semaglutide 1.0 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.25|-1.81|< 0.0001
71865572|NCT01253135|143246509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.7||0.3393|TWO_SIDED|95.0|-3.08|0.84|||Prentice-Wilcoxon test||The Confidence Interval was based on a t-distribution|||0.84|-3.08|.3393
71911031|NCT00425100|143342825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.1|<|0.0001||95.0|-3.2|-2.7||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-2.7|-3.2|<0.0001
71911032|NCT00425100|143342826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.4|<|0.0001||95.0|-2.0|-1.4||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-1.4|-2.0|<0.0001
71911033|NCT00425100|143342827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.0|STANDARD_DEVIATION|4.8|<|0.0001||95.0|-5.4|-4.5||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.||-4.5|-5.4|<0.0001
71911034|NCT00425100|143342829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2 sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911035|NCT00425100|143342830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.5|STANDARD_DEVIATION|4.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911036|NCT00425100|143342831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911037|NCT00425100|143342832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8|STANDARD_DEVIATION|1.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911038|NCT00425100|143342834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71865573|NCT01253135|143246510|SUPERIORITY_OR_OTHER|||||||0.4771|TWO_SIDED||||||Log Rank|Testing was by a Log Rank test with significance being at P \< 0.05||||||.4771
71865574|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|77.4||||||95.0||||||||||||
71865575|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|28.4||||||95.0||||||||||||
71865576|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.7||||||95.0||||||||||||
71865577|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|4.9||||||95.0||||||||||||
71865578|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|79.2||||||95.0||||||||||||
71865579|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.1||||||95.0||||||||||||
71865580|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|3.8||||||95.0||||||||||||
71865581|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|6.1||||||95.0||||||||||||
71865582|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|82.4||||||95.0||||||||||||
71865583|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|23.5||||||95.0||||||||||||
71865584|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|5.9||||||95.0||||||||||||
71865585|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|5.8||||||95.0||||||||||||
71865586|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with TEAEs|76.9||||||95.0||||||||||||
71865587|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with related AEs|20.0||||||95.0||||||||||||
71865588|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with severe AEs|6.2||||||95.0||||||||||||
71865589|NCT00379288|143246547|SUPERIORITY_OR_OTHER_LEGACY||percentage of subjects with serious AEs|3.1||||||95.0||||||||||||
71865590|NCT00918879|143246548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.139||0.0011||95.0|-0.73|-0.18|||ANCOVA|\* adjusted for baseline HbA1c||||-0.18|-0.73|0.0011
71865591|NCT00918879|143246549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.19|STANDARD_ERROR_OF_MEAN|5.438||0.0623||95.0|-20.91|0.53|||ANCOVA|\* Adjusted for baseline FPG||||0.53|-20.91|0.0623
71865592|NCT00918879|143246550|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.302||0.0623||95.0|-1.17|0.02|||ANCOVA|\* Adjusted for baseline FPG||||0.02|-1.17|0.0623
71865593|NCT00918879|143246551|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.8||||||95.0|-1.7|19.3|||Fisher Exact|||||19.3|-1.7|
71865594|NCT05602727|143246570|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|2.1||||0.186|TWO_SIDED|97.5|-1.6|5.8|||Longitudinal ANCOVA|||||5.8|-1.6|0.186
71865595|NCT05602727|143246570|SUPERIORITY|Difference in LS Means (MK-1942 - Placebo)|LS Mean Difference|-1.4||||0.4|TWO_SIDED|97.5|-5.2|2.4|||Longitudinal ANCOVA|||||2.4|-5.2|0.400
71865596|NCT05602727|143246574|SUPERIORITY|Difference in LS Means|LS Mean Difference|-2.9||||0.196|TWO_SIDED|97.5|-8.0|2.2|||Longitudinal ANCOVA|||||2.2|-8.0|0.196
71865597|NCT05602727|143246574|SUPERIORITY|Difference in LS Means|LS Mean Difference|-4.2||||0.081|TWO_SIDED|97.5|-9.6|1.3|||Longitudinal ANCOVA|||||1.3|-9.6|0.081
71865598|NCT01712061|143246601|SUPERIORITY_OR_OTHER||Ratio of geometric mean changes|0.92|||||TWO_SIDED|95.0|0.75|1.09|||ANCOVA|Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).||||1.09|0.75|
71865599|NCT02278484|143246630|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71865600|NCT01401153|143246632|NON_INFERIORITY_OR_EQUIVALENCE|Power calculation based on parallel group design --\> revealed that 68 children are needed to detect a difference of 45ms in the mean reaction time between the groups, with α=.05 and a power of 0.8.||||||0.79|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||Power calculation had been performed.||||0.79
71865601|NCT01401153|143246633|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.07|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.07
71865602|NCT01401153|143246634|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.61|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.61
71865603|NCT01401153|143246635|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been perfomed based on this measure||||||0.03|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.03
71865604|NCT01401153|143246636|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.25|||||||Generalized linear models|The fixed statement considered treatment, test day and the interaction between treatment and test day||||||0.25
71911039|NCT00425100|143342836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.6|STANDARD_DEVIATION|26.4|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911040|NCT00425100|143342837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.6|STANDARD_DEVIATION|26.6|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911041|NCT00425100|143342838|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|27.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71911042|NCT00425100|143342839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.8|STANDARD_DEVIATION|21.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71865605|NCT01401153|143246637|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.7|||||||Generalized linear models|||||||0.70
71911043|NCT00425100|143342840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.1|STANDARD_DEVIATION|22.8|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71865606|NCT01401153|143246638|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.33|||||||Generalized linear models|||||||0.33
71865607|NCT01401153|143246639|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.63|||||||Generalized linear models|||||||0.63
71865608|NCT01401153|143246640|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.62|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.62
71865609|NCT01401153|143246641|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.11|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.11
71865610|NCT01401153|143246642|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.45|||||||t-test, 2 sided|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.45
71865611|NCT01401153|143246643|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.13|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.13
71865612|NCT01401153|143246644|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.68|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.68
71865613|NCT01401153|143246645|NON_INFERIORITY_OR_EQUIVALENCE|No power calculation had been performed based on this measure||||||0.67|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||||||0.67
71865614|NCT03846453|143246657|SUPERIORITY||Least Squares (LS) Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.064||0.1871|TWO_SIDED|95.0|-0.04|0.21||P-value calculated using a model with treatment, baseline score, and site as covariates.|ANCOVA|||||0.21|-0.04|0.1871
71865615|NCT03846453|143246658|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.09||0.5549|TWO_SIDED|95.0|-0.12|0.23|||ANCOVA|P-value calculated using a model with treatment, baseline score, and site as covariates.||||0.23|-0.12|0.5549
71865616|NCT00368927|143246770|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Fisher Exact|||With a sample size of 60 evaluable participants per intervention arm, we would have 90% power to detect a bronchial dysplasia response rate of 54% and 82% power to detect a bronchial dysplasia response rate of\> 51% among participants assigned to receive active sulindac (2-sided chi-square test with continuity correction; alpha=0.05).||||0.85
71682525|NCT01592292|142883286|SUPERIORITY_OR_OTHER|||||||0.2549||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2549
71682526|NCT01592292|142883286|SUPERIORITY_OR_OTHER|||||||0.7644||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.7644
71682527|NCT01592292|142883287|SUPERIORITY_OR_OTHER|||||||0.8987||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.8987
71865617|NCT00368927|143246771|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||A sample size of 60 participants per intervention arm would provide 90% power and 80% power to detect effect sizes of 60% and 52%, respectively, using a two-sample t-test(alpha=0.05).||||0.63
71865618|NCT02229851|143246802|SUPERIORITY||Treatment difference|-1.53|||=|0.009|TWO_SIDED|95.0|-2.68|-0.38|||ANCOVA||Somapacitan-Placebo|Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm.||-0.38|-2.68|=0.0090
71865619|NCT01607476|143246942|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865620|NCT01607476|143246942|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865621|NCT01607476|143246942|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865622|NCT01607476|143246943|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865623|NCT01607476|143246943|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865624|NCT01607476|143246943|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71865625|NCT02299414|143246944|SUPERIORITY||Risk Ratio (RR)|0.82|||<|0.001|TWO_SIDED|95.0|0.73|0.92|||Chi-squared|||||.92|.73|<0.001
71865626|NCT02299414|143246944|SUPERIORITY||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.7|0.9||||||||.90|.70|
71865627|NCT02299414|143246944|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.6|0.89||||||||.89|.60|
71865628|NCT02299414|143246944|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.49|1.64||||||||1.64|.49|
71865629|NCT02299414|143246944|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.54|1.21||||||||1.21|.54|
71865630|NCT02299414|143246945|SUPERIORITY||Risk Ratio (RR)|1.07||||0.56|TWO_SIDED|95.0|0.85|1.36|||Chi-squared|||||1.36|0.85|0.56
71865631|NCT02299414|143246946|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.45|1.26||||||||1.26|.45|
71865632|NCT02299414|143246947|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.77|0.91||||||||0.91|0.77|
71865633|NCT02299414|143246948|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.77|0.99||||||||.99|.77|
71865634|NCT02299414|143246949|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.45|1.3||||||||1.3|.45|
71865635|NCT02299414|143246950|SUPERIORITY||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.98|1.18||||||||1.18|.98|
71865636|NCT02299414|143246951|SUPERIORITY||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.69|0.89||||||||.89|.69|
71865637|NCT02299414|143246952|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.68|1.04||||||||1.04|0.68|
71865638|NCT02299414|143246953|SUPERIORITY||Risk Ratio (RR)|0.82|||||TWO_SIDED|95.0|0.74|0.9||||||||.90|.74|
71865639|NCT02299414|143246954|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.93|1.1||||||||1.10|.93|
71865640|NCT02299414|143246955|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.59|1.27||||||||1.27|.59|
71865641|NCT02299414|143246956|SUPERIORITY||Risk Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.81|1.02||||||||1.02|.81|
71865642|NCT02299414|143246957|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.71|0.97||||||||.97|.71|
71865643|NCT02299414|143246958|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.11|0.43||||||||0.43|-0.11|
71865644|NCT02299414|143246959|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|0.05|0.56||||||||0.56|0.05|
71865645|NCT02299414|143246960|SUPERIORITY||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-17.6|20.9||||||||20.9|-17.6|
71865646|NCT02299414|143246961|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.81|1.17||||||||1.17|.81|
71865647|NCT02299414|143246962|SUPERIORITY||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.55|1.42||||||||1.42|.55|
71865648|NCT02299414|143246963|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.18|1.05||||||||1.05|.18|
71865649|NCT02299414|143246964|SUPERIORITY||Risk Ratio (RR)|0.87|||||TWO_SIDED|95.0|0.71|1.06||||||||1.06|.71|
71865650|NCT02299414|143246965|SUPERIORITY||Risk Ratio (RR)|0.57|||||TWO_SIDED|95.0|0.24|1.35||||||||1.35|.24|
71865651|NCT02299414|143246966|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.85|1.12||||||||1.12|.85|
71865652|NCT02299414|143246967|SUPERIORITY||Risk Ratio (RR)|0.64|||||TWO_SIDED|95.0|0.3|1.37||||||||1.37|0.30|
71865653|NCT02299414|143246968|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.14|7.06||||||||7.06|.14|
71865654|NCT02299414|143246969|SUPERIORITY||Risk Ratio (RR)|0.93|||||TWO_SIDED|95.0|0.81|1.08||||||||1.08|.81|
71865655|NCT02299414|143246970|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.62|1.16||||||||1.16|0.62|
71865656|NCT02299414|143246971|SUPERIORITY||Risk Ratio (RR)|0.61|||||TWO_SIDED|95.0|0.36|1.05||||||||1.05|.36|
71865657|NCT02299414|143246972|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.2|0.03||||||||0.03|-0.2|
71865658|NCT02299414|143246973|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
71865659|NCT02299414|143246974|SUPERIORITY||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.12|0.002||||||||0.002|-0.12|
71865660|NCT02299414|143246975|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.02|0.04||||||||0.04|-0.02|
71865661|NCT02299414|143246976|SUPERIORITY||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.9|1.06||||||||1.06|0.90|
71865662|NCT04655027|143247003|OTHER|Treatment effect|Difference in Estimate (LSM)|19.5|STANDARD_ERROR_OF_MEAN|15.62||0.212|TWO_SIDED|95.0|-11.155|50.15|||ANCOVA|||||50.150|-11.155|0.212
71865663|NCT04655027|143247004|OTHER|Baseline hepcidin by treatment effect|Difference in Estimate|-0.13|STANDARD_ERROR_OF_MEAN|0.17||0.441|TWO_SIDED|95.0|-0.477|0.208|||ANCOVA|||||0.208|-0.477|0.441
71865664|NCT04655027|143247004|OTHER|Baseline hs CRP by treatment effect|Difference in Estimates|-2.34|STANDARD_ERROR_OF_MEAN|3.76||0.532|TWO_SIDED|95.0|-9.707|5.017|||ANCOVA|||||5.017|-9.707|0.532
71865665|NCT04655027|143247005|OTHER|Treatment effect|Ratio of Estimates|1.09|STANDARD_ERROR_OF_MEAN|1.23||0.688|TWO_SIDED|95.0|0.723|1.635|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.635|0.723|0.688
71865666|NCT04655027|143247005|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.43|STANDARD_ERROR_OF_MEAN|0.2||0.029|TWO_SIDED|95.0|0.045|0.822|||ANCOVA|||||0.822|0.045|0.029
71865667|NCT04655027|143247005|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.568|TWO_SIDED|95.0|-0.201|0.366|||ANCOVA|||||0.366|-0.201|0.568
71865668|NCT04655027|143247006|OTHER|Treatment effect|Ratio of Estimates|0.84|STANDARD_ERROR_OF_MEAN|1.11||0.096|TWO_SIDED|95.0|0.687|1.031|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.031|0.687|0.096
71865669|NCT04655027|143247006|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.63|TWO_SIDED|95.0|-0.282|0.171|||ANCOVA|||||0.171|-0.282|0.630
71865670|NCT04655027|143247006|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.015|TWO_SIDED|95.0|0.037|0.342|||ANCOVA|||||0.342|0.037|0.015
71865671|NCT04655027|143247007|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.123|1.354|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.354|1.123|< 0.001
71911044|NCT00425100|143342841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.7|STANDARD_DEVIATION|22.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71865672|NCT04655027|143247007|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.171|TWO_SIDED|95.0|-0.027|0.149|||ANCOVA|||||0.149|-0.027|0.171
71865673|NCT04655027|143247007|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.03|STANDARD_ERROR_OF_MEAN|0.04||0.387|TWO_SIDED|95.0|-0.039|0.101|||ANCOVA|||||0.101|-0.039|0.387
71865674|NCT04655027|143247008|OTHER|Treatment effect|Ratio of Estimates|0.89|STANDARD_ERROR_OF_MEAN|1.22||0.561|TWO_SIDED|95.0|0.606|1.312|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.312|0.606|0.561
71865675|NCT04655027|143247008|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.38|STANDARD_ERROR_OF_MEAN|0.19||0.043|TWO_SIDED|95.0|0.013|0.75|||ANCOVA|||||0.750|0.013|0.043
71865676|NCT04655027|143247008|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.13||0.766|TWO_SIDED|95.0|-0.222|0.302|||ANCOVA|||||0.302|-0.222|0.766
71865677|NCT04655027|143247009|OTHER|Treatment effect|Ratio of Estimates|1.23|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.108|1.369|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.369|1.108|< 0.001
71865678|NCT04655027|143247009|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.351|TWO_SIDED|95.0|-0.059|0.159|||ANCOVA|||||0.159|-0.059|0.351
71865679|NCT04655027|143247009|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.248|TWO_SIDED|95.0|-0.031|0.114|||ANCOVA|||||0.114|-0.031|0.248
71865680|NCT04655027|143247010|OTHER|Treatment effect|Ratio of Estimates|1.29|STANDARD_ERROR_OF_MEAN|1.11||0.021|TWO_SIDED|95.0|1.043|1.598|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||1.598|1.043|0.021
71865681|NCT04655027|143247010|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.826|TWO_SIDED|95.0|-0.276|0.223|||ANCOVA|||||0.223|-0.276|0.826
71865682|NCT04655027|143247010|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|-0.04|STANDARD_ERROR_OF_MEAN|0.08||0.634|TWO_SIDED|95.0|-0.212|0.132|||ANCOVA|||||0.132|-0.212|0.634
71911045|NCT00425100|143342843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.2|STANDARD_DEVIATION|14.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.||||<0.0001
71865683|NCT04655027|143247011|OTHER|Treatment effect|Ratio of Estimates|0.45|STANDARD_ERROR_OF_MEAN|1.31||0.007|TWO_SIDED|95.0|0.257|0.786|||Geometric ANCOVA|Geometric ANCOVA of relative change from baseline. The Standard error of Mean (SEM) refers to Geometric SEM.||||0.786|0.257|0.007
71865684|NCT04655027|143247011|OTHER|Baseline hepcidin-by-treatment effect|Difference in Estimates|-0.16|STANDARD_ERROR_OF_MEAN|0.31||0.61|TWO_SIDED|95.0|-0.798|0.48|||ANCOVA|||||0.480|-0.798|0.610
71865685|NCT04655027|143247011|OTHER|Baseline hs-CRP-by-treatment effect|Difference in Estimates|0.07|STANDARD_ERROR_OF_MEAN|0.22||0.74|TWO_SIDED|95.0|-0.387|0.536|||ANCOVA|||||0.536|-0.387|0.740
71865686|NCT03578887|143247035|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<0.001
71865687|NCT03578887|143247036|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
71865688|NCT01531673|143247067|SUPERIORITY||Least Squares (LS) Mean Difference|4.77||||0.0647|TWO_SIDED|95.0|-0.3|9.84|||Mixed-effect repeated measure (MMRM)|||||9.84|-0.3|0.0647
71865689|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-3.91||||0.1686|TWO_SIDED|95.0|-9.5|1.68|||MMRM|||||1.68|-9.5|0.1686
71865690|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-4.2||||0.0348|TWO_SIDED|95.0|-8.1|-0.31|||MMRM|||||-0.31|-8.1|0.0348
71865691|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-19.58|||<|0.0001|TWO_SIDED|95.0|-24.57|-14.59|||MMRM|||||-14.59|-24.57|<0.0001
71865692|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-5.14||||0.0101|TWO_SIDED|95.0|-9.03|-1.25|||MMRM|||||-1.25|-9.03|0.0101
71865693|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-5.19||||0.011|TWO_SIDED|95.0|-9.16|-1.21|||MMRM|||||-1.21|-9.16|0.011
71865694|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-9.6||||0.0001|TWO_SIDED|95.0|-14.38|-4.82|||MMRM|||||-4.82|-14.38|0.0001
71865695|NCT01531673|143247067|SUPERIORITY||LS Mean Difference|-1.77||||0.3745|TWO_SIDED|95.0|-5.71|2.17|||MMRM|||||2.17|-5.71|0.3745
71865696|NCT01531673|143247068|SUPERIORITY||LS Mean Difference|-6.7||||0.0357|TWO_SIDED|95.0|-12.94|-0.46|||MMRM|||||-0.46|-12.94|0.0357
71865697|NCT01531673|143247069|SUPERIORITY||LS Mean Difference|-17.2||||0.0238|TWO_SIDED|95.0|-31.75|-2.65|||MMRM|||||-2.65|-31.75|0.0238
71865698|NCT00568178|143247084|SUPERIORITY_OR_OTHER_LEGACY||Ratio in Geometric Mean|0.63||||0.001|TWO_SIDED|95.0|0.54|0.74|||Mixed Models Analysis|||||0.74|0.54|0.001
71911046|NCT03162458|143342864|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71911047|NCT03162458|143342865|SUPERIORITY|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||||||0.0004
71911048|NCT03162458|143342866|SUPERIORITY|||||||0.055|||||||Log Rank|||||||0.055
71911049|NCT03162458|143342867|SUPERIORITY|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||||||0.051
71911050|NCT03162458|143342868|SUPERIORITY|||||||0.19|||||||ANOVA|||Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)||||0.19
71682528|NCT01592292|142883287|SUPERIORITY_OR_OTHER|||||||0.5808||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA|||||||0.5808
71865699|NCT00568178|143247085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4||||||95.0|-9.9|-1.0|||Mixed Models Analysis|||||-1.0|-9.9|
71865700|NCT00568178|143247086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6||||||95.0|-9.2|-0.1|||Mixed Models Analysis|||||-0.1|-9.2|
71865701|NCT00568178|143247087|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio|1.18|||||TWO_SIDED|95.0|0.86|1.6||No P Value was calculated for this outcome.|Mixed Models Analysis|An unstructured variance-covariance was used.||||1.60|0.86|
71865702|NCT00568178|143247088|SUPERIORITY_OR_OTHER_LEGACY||Least Square Mean|-3.8||||||95.0|-15.2|7.6||A P-Value was not calculated for this outcome.|Mixed Models Analysis|||||7.6|-15.2|
71865703|NCT01008553|143247089|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Log Rank|||||||0.0003
71865704|NCT02187159|143247114|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.183||0.0008|TWO_SIDED|95.0|-0.97|-0.25|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.25|-0.97|0.0008
71865705|NCT02187159|143247114|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.183||0.0392|TWO_SIDED|95.0|-0.74|-0.02|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.02|-0.74|0.0392
71865706|NCT02187159|143247114|SUPERIORITY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.183||0.2192|TWO_SIDED|95.0|-0.58|0.13|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.13|-0.58|0.2192
71865707|NCT02187159|143247114|SUPERIORITY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.184||0.2095|TWO_SIDED|95.0|-0.13|0.59|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.59|-0.13|0.2095
71865708|NCT02187159|143247114|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.185||0.0381|TWO_SIDED|95.0|0.02|0.75|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.75|0.02|0.0381
71865709|NCT02187159|143247116|SUPERIORITY||Mean Difference (Final Values)|-7.67|STANDARD_ERROR_OF_MEAN|1.598|<|0.0001|TWO_SIDED|95.0|-10.71|-4.44|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-4.44|-10.71|<0.0001
71865710|NCT02187159|143247116|SUPERIORITY||Mean Difference (Final Values)|-3.52|STANDARD_ERROR_OF_MEAN|1.613||0.0289|TWO_SIDED|95.0|-6.68|-0.36|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||-0.36|-6.68|0.0289
71865711|NCT02187159|143247116|SUPERIORITY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.625||0.1148|TWO_SIDED|95.0|-5.75|0.62|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||0.62|-5.75|0.1148
71865712|NCT02187159|143247116|SUPERIORITY||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|1.621||0.0125|TWO_SIDED|95.0|0.87|7.23|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||7.23|0.87|0.0125
71865713|NCT02187159|143247116|SUPERIORITY||Mean Difference (Final Values)|5.01|STANDARD_ERROR_OF_MEAN|1.647||0.0023|TWO_SIDED|95.0|1.78|8.24|||Difference of means|||Analysis was based on multiple imputation and pattern mixture model with delta shifting.||8.24|1.78|0.0023
71865714|NCT02187159|143247118|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-1.8|-0.7|||ANCOVA|||||-0.7|-1.8|<0.0001
71911051|NCT03162458|143342868|SUPERIORITY|||||||0.44|||||||ANOVA|||Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)||||0.44
71911052|NCT03162458|143342869|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
71911053|NCT03162458|143342870|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
71865715|NCT02187159|143247118|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0247|TWO_SIDED|95.0|-1.2|-0.1|||ANCOVA|||||-0.1|-1.2|0.0247
71865716|NCT02187159|143247118|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0411|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||-0.0|-1.1|0.0411
71865717|NCT02187159|143247118|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.29||0.0352|TWO_SIDED|95.0|0.0|1.2|||ANCOVA|||||1.2|0.0|0.0352
71865718|NCT02187159|143247118|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0214|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||||1.2|0.1|0.0214
71911054|NCT03162458|143342871|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71911055|NCT03162458|143342872|SUPERIORITY|||||||0.63|||||||ANOVA|||||||0.63
71911056|NCT03162458|143342873|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71911057|NCT00788697|143342876|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|11.3||||0.0754|TWO_SIDED|95.0|-1.0|23.6|||McNemar|||||23.6|-1.0|0.0754
71911058|NCT00788697|143342876|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|19.4||||0.0011|TWO_SIDED|95.0|8.3|30.5|||McNemar|||||30.5|8.3|0.0011
71911059|NCT00788697|143342876|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|-19.4||||0.0016|TWO_SIDED|95.0|-30.9|-7.8|||McNemar|||||-7.8|-30.9|0.0016
71911060|NCT00788697|143342877|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|47.4|||<|0.0001|TWO_SIDED|95.0|37.4|57.4|||McNemar|||||57.4|37.4|<.0001
71911061|NCT00788697|143342877|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|60.3|||<|0.0001|TWO_SIDED|95.0|50.5|70.2|||McNemar|||||70.2|50.5|<.0001
71911062|NCT00788697|143342877|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|29.3|||<|0.0001|TWO_SIDED|95.0|19.7|38.9|||McNemar|||||38.9|19.7|<.0001
71911063|NCT00788697|143342878|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|28.8|||<|0.0001|TWO_SIDED|95.0|20.5|37.0|||McNemar|||||37.0|20.5|<.0001
71911064|NCT00788697|143342878|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|39.2|||<|0.0001|TWO_SIDED|95.0|31.3|47.1|||McNemar|||||47.1|31.3|<.0001
71682529|NCT01592292|142883288|SUPERIORITY_OR_OTHER|||||||0.2282||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.2282
71682530|NCT01592292|142883288|SUPERIORITY_OR_OTHER|||||||0.5849||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.5849
71865719|NCT02187159|143247119|SUPERIORITY||Difference of least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.26||0.0003|TWO_SIDED|95.0|-1.5|-0.4|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||-0.4|-1.5|0.0003
71865720|NCT02187159|143247119|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.5066|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.3|-0.7|0.5066
71865721|NCT02187159|143247119|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.26||0.1462|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.1|-0.9|0.1462
71865722|NCT02187159|143247119|SUPERIORITY||Difference of least squares means|0.8|STANDARD_ERROR_OF_MEAN|0.26||0.0035|TWO_SIDED|95.0|0.3|1.3|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.3|0.3|0.0035
71865723|NCT02187159|143247119|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.0338|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.1|0.0|0.0338
71865724|NCT02187159|143247119|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0116|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||-0.2|-1.3|0.0116
71865725|NCT02187159|143247119|SUPERIORITY||Difference of least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7085|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.7085
71865726|NCT02187159|143247119|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.9392|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.5|0.9392
71865727|NCT02187159|143247119|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0311|TWO_SIDED|95.0|0.1|1.2|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.2|0.1|0.0311
71865728|NCT02187159|143247119|SUPERIORITY||Difference in least squares means|0.7|STANDARD_ERROR_OF_MEAN|0.28||0.0094|TWO_SIDED|95.0|0.2|1.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.3|0.2|0.0094
71865729|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|1.256|STANDARD_ERROR_OF_MEAN|0.6027||0.0373|TWO_SIDED|95.0|0.074|2.439|||ANCOVA|||Physical Component: Placebo vs Pregabalin||2.439|0.074|0.0373
71865730|NCT02187159|143247120|SUPERIORITY||Difference of least squares means|0.364|STANDARD_ERROR_OF_MEAN|0.602||0.5458|TWO_SIDED|95.0|-0.817|1.545|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||1.545|-0.817|0.5458
71911065|NCT00788697|143342878|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|4.2||||0.3173|TWO_SIDED|95.0|-4.0|12.3|||McNemar|||||12.3|-4.0|0.3173
71682531|NCT01592292|142883289|SUPERIORITY_OR_OTHER|||||||0.49||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.4900
71682532|NCT01592292|142883289|SUPERIORITY_OR_OTHER|||||||0.1826||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1826
71682533|NCT01592292|142883290|SUPERIORITY_OR_OTHER|||||||0.1894||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1894
71865731|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|0.235|STANDARD_ERROR_OF_MEAN|0.6038||0.6968|TWO_SIDED|95.0|-0.949|1.42|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||1.420|-0.949|0.6968
71865732|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|-0.893|STANDARD_ERROR_OF_MEAN|0.6014||0.1379|TWO_SIDED|95.0|-2.073|0.287|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg QD||0.287|-2.073|0.1379
71865733|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|-1.021|STANDARD_ERROR_OF_MEAN|0.6033||0.0908|TWO_SIDED|95.0|-2.205|0.163|||ANCOVA|||Physical Component: Pregabalin vs DS-5565 15 mg BID||0.163|-2.205|0.0908
71865734|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|1.89|STANDARD_ERROR_OF_MEAN|0.6965||0.0068|TWO_SIDED|95.0|0.523|3.256|||ANCOVA|||Mental Component: Placebo vs Pregabalin||3.256|0.523|0.0068
71865735|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|0.406|STANDARD_ERROR_OF_MEAN|0.6956||0.5594|TWO_SIDED|95.0|-0.959|1.771|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.771|-0.959|0.5594
71865736|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|0.023|STANDARD_ERROR_OF_MEAN|0.6979||0.9736|TWO_SIDED|95.0|-1.346|1.392|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.392|-1.346|0.9736
71865737|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|-1.484|STANDARD_ERROR_OF_MEAN|0.6953||0.0331|TWO_SIDED|95.0|-2.848|-0.119|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg QD||-0.119|-2.848|0.0331
71865738|NCT02187159|143247120|SUPERIORITY||Difference in least squares means|-1.867|STANDARD_ERROR_OF_MEAN|0.6976||0.0076|TWO_SIDED|95.0|-3.235|-0.498|||ANCOVA|||Mental Component: Pregabalin vs DS-5565 15 mg BID||-0.498|-3.235|0.0076
71865739|NCT02187159|143247121|SUPERIORITY||Difference in least squares means|0.0309|STANDARD_ERROR_OF_MEAN|0.01328||0.0201|TWO_SIDED|95.0|0.0048|0.057|||ANCOVA|||||0.0570|0.0048|0.0201
71865740|NCT02187159|143247121|SUPERIORITY||Difference of least squares means|0.0178|STANDARD_ERROR_OF_MEAN|0.01324||0.1798|TWO_SIDED|95.0|-0.0082|0.0438|||ANCOVA|||||0.0438|-0.0082|0.1798
71911066|NCT00788697|143342879|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71911067|NCT00788697|143342879|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71911068|NCT00788697|143342879|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Wald Test|||||||0.0004
71911069|NCT00788697|143342880|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71911070|NCT00788697|143342880|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71911071|NCT00788697|143342880|SUPERIORITY_OR_OTHER|||||||0.761|||||||Wald Test|||||||0.7610
71911072|NCT01412060|143342890|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.001|TWO_SIDED|95.0|0.28|0.73|||Log Rank||Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.|||0.73|0.28|0.0010
71682534|NCT01592292|142883290|SUPERIORITY_OR_OTHER|||||||0.1805||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA|||||||0.1805
71865741|NCT02187159|143247121|SUPERIORITY||Difference of least squares means|0.0071|STANDARD_ERROR_OF_MEAN|0.01329||0.5922|TWO_SIDED|95.0|-0.0189|0.0332|||ANCOVA|||||0.0332|-0.0189|0.5922
71865742|NCT02187159|143247121|SUPERIORITY||Difference in least squares means|-0.0131|STANDARD_ERROR_OF_MEAN|0.01326||0.3221|TWO_SIDED|95.0|-0.0392|0.0129|||ANCOVA|||||0.0129|-0.0392|0.3221
71865743|NCT02187159|143247121|SUPERIORITY||Difference in least squares means|-0.0238|STANDARD_ERROR_OF_MEAN|0.0133||0.0739|TWO_SIDED|95.0|-0.0499|0.0023|||ANCOVA|||||0.0023|-0.0499|0.0739
71865744|NCT02187159|143247122|SUPERIORITY||Difference in least squares means|-0.49|STANDARD_ERROR_OF_MEAN|0.153||0.0015|TWO_SIDED|95.0|-0.79|-0.19|||Mixed Models Analysis|||||-0.19|-0.79|0.0015
71865745|NCT02187159|143247122|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.153||0.0003|TWO_SIDED|95.0|-0.86|-0.26|||Mixed Models Analysis|||||-0.26|-0.86|0.0003
71865746|NCT02187159|143247122|SUPERIORITY||Difference in least squares means|-0.51|STANDARD_ERROR_OF_MEAN|0.153||0.0008|TWO_SIDED|95.0|-0.81|-0.21|||Mixed Models Analysis|||||-0.21|-0.81|0.0008
71865747|NCT02187159|143247122|SUPERIORITY||Difference in least squares means|-0.07|STANDARD_ERROR_OF_MEAN|0.154||0.6464|TWO_SIDED|95.0|-0.37|0.23|||Mixed Models Analysis|||||0.23|-0.37|0.6464
71865748|NCT02187159|143247122|SUPERIORITY||Difference in least squares means|-0.03|STANDARD_ERROR_OF_MEAN|0.154||0.8543|TWO_SIDED|95.0|-0.33|0.27|||Mixed Models Analysis|||||0.27|-0.33|0.8543
71865749|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.0014|TWO_SIDED|95.0|-1.0|0.2|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.2|-1.0|0.0014
71911073|NCT01062009|143342935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||Chi square analysis comparing number of participants with new fever in each group||||0.24
71911074|NCT01468701|143342938|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.6|0.9|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.90|0.60|
71865750|NCT02187159|143247124|SUPERIORITY||Difference of least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1285|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1285
71865751|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.6595|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6595
71865752|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0938|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0938
71865753|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0061|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0061
71865754|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0235|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.1|-0.8|0.0235
71682535|NCT01592292|142883291|SUPERIORITY_OR_OTHER|||||||0.0568||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.0568
71865755|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3652|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3652
71865756|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.6885|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.3|-0.4|0.6885
71865757|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1726|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1726
71865758|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.0|0.0627
71865759|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.0026|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.2|-0.8|0.0026
71865760|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1362|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.1362
71865761|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4344|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.4|0.4344
71865762|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1264|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.1|0.1264
71865763|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.16||0.026|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|0.0|0.0260
71865764|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|0.0002
71865765|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0597|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0597
71865766|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1198|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.1|-0.7|0.1198
71865767|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.563|STANDARD_ERROR_OF_MEAN|0.1644||0.0006|TWO_SIDED|95.0|-0.885|-0.24|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.240|-0.885|0.0006
71911075|NCT01468701|143342940|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.63|0.98|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.98|0.63|
71865768|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.261|STANDARD_ERROR_OF_MEAN|0.164||0.1118|TWO_SIDED|95.0|-0.583|0.061|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.061|-0.583|0.1118
71865769|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.142|STANDARD_ERROR_OF_MEAN|0.1646||0.387|TWO_SIDED|95.0|-0.465|0.18|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.180|-0.465|0.3870
71865770|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.302|STANDARD_ERROR_OF_MEAN|0.1642||0.0633|TWO_SIDED|95.0|-0.02|0.624|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.624|-0.020|0.0633
71865771|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.42|STANDARD_ERROR_OF_MEAN|0.1647||0.0108|TWO_SIDED|95.0|0.097|0.744|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.744|0.097|0.0108
71865772|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|7.5|STANDARD_ERROR_OF_MEAN|2.41||0.002|TWO_SIDED|95.0|2.7|12.2|||ANCOVA|||Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID||12.2|2.7|0.0020
71865773|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|3.0|STANDARD_ERROR_OF_MEAN|2.41||0.2188|TWO_SIDED|95.0|-1.8|7.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg QD||7.7|-1.8|0.2188
71865774|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|4.0|STANDARD_ERROR_OF_MEAN|2.41||0.0991|TWO_SIDED|95.0|-0.8|8.7|||ANCOVA|||Relief by treatment of pain: Placebo vs DS-5565 15 mg BID||8.7|-0.8|0.0991
71865775|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-4.5|STANDARD_ERROR_OF_MEAN|2.41||0.0611|TWO_SIDED|95.0|-9.2|0.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.2|-9.2|0.0611
71865776|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-3.5|STANDARD_ERROR_OF_MEAN|2.41||0.1489|TWO_SIDED|95.0|-8.2|1.2|||ANCOVA|||Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.2|-8.2|0.1489
71865777|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-6.04|STANDARD_ERROR_OF_MEAN|1.751||0.0006|TWO_SIDED|95.0|-9.47|-2.6|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-2.60|-9.47|0.0006
71865778|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-4.09|STANDARD_ERROR_OF_MEAN|1.747||0.0193|TWO_SIDED|95.0|-7.52|-0.67|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||-0.67|-7.52|0.0193
71865779|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-1.64|STANDARD_ERROR_OF_MEAN|1.752||0.3506|TWO_SIDED|95.0|-5.07|1.8|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.80|-5.07|0.3506
71865780|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|1.94|STANDARD_ERROR_OF_MEAN|1.748||0.266|TWO_SIDED|95.0|-1.48|5.37|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.37|-1.48|0.2660
71865781|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|4.4|STANDARD_ERROR_OF_MEAN|1.754||0.0122|TWO_SIDED|95.0|0.96|7.84|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||7.84|0.96|0.0122
71865782|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.2||0.0119|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0119
71865783|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0659|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0659
71865784|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5104|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5104
71865785|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.4934|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.4934
71865786|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0634|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0634
71865787|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.0007|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.3|-1.1|0.0007
71865788|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0837|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.0|-0.8|0.0837
71865789|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.2379|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.7|0.2379
71865790|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.098|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.0980
71865791|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0283|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0283
71865792|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2179|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2179
71865793|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6683|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6683
71865794|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2247|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.7|-0.2|0.2247
71865795|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.21||0.4198|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.2|0.4198
71865796|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0146|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0146
71865797|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0662|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.0|-0.8|0.0662
71682536|NCT01592292|142883292|SUPERIORITY_OR_OTHER|||||||0.1167||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA|||||||0.1167
71682537|NCT03660475|142883326|SUPERIORITY|||||||0.967|||||||t-test, 2 sided|||||||0.967
71682538|NCT03660475|142883327|SUPERIORITY|||||||0.836|||||||t-test, 2 sided|||||||0.836
71865798|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.2282|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.2|-0.7|0.2282
71865799|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7336|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.7336
71682539|NCT03660475|142883328|SUPERIORITY|||||||0.166|||||||t-test, 2 sided|||||||0.166
71682540|NCT03660475|142883329|SUPERIORITY|||||||0.638|||||||t-test, 2 sided|||||||0.638
71682541|NCT03660475|142883330|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
71865800|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.524|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.5240
71865801|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1349|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1349
71865802|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0464|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0464
71865803|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0975|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.0975
71865804|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6088|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.5|-0.3|0.6088
71865805|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7341|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.7341
71865806|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0125|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.1|0.0125
71865807|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-1.0|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-1.4|-0.5|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.5|-1.4|<0.0001
71865808|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.23||0.0003|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||-0.4|-1.3|0.0003
71865809|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.23||0.004|TWO_SIDED|95.0|-1.1|-0.2|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.2|-1.1|0.0040
71865810|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5801|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5801
71865811|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.1869|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1869
71865812|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.22||0.0002|TWO_SIDED|95.0|-1.3|-0.4|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||-0.4|-1.3|0.0002
71865813|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0271|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||-0.1|-0.9|0.0271
71865814|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.1123|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.1|-0.8|0.1123
71865815|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.1183|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1183
71865816|NCT02187159|143247124|SUPERIORITY||Difference in least squares means|0.5|STANDARD_ERROR_OF_MEAN|0.22||0.0299|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|0.0|0.0299
71865817|NCT02187159|143247125|SUPERIORITY||Difference in least squares means|-0.015|STANDARD_ERROR_OF_MEAN|0.0249||0.5578|TWO_SIDED|95.0|-0.063|0.034|||ANCOVA|||||0.034|-0.063|0.5578
71682542|NCT03660475|142883331|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
71682543|NCT03660475|142883332|SUPERIORITY|||||||0.085|||||||t-test, 2 sided|||||||0.085
71682544|NCT03660475|142883334|SUPERIORITY|||||||0.903|||||||t-test, 2 sided|||||||0.903
71682545|NCT03660475|142883335|SUPERIORITY|||||||0.898|||||||t-test, 2 sided|||||||0.898
71682546|NCT03660475|142883336|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
71682547|NCT03660475|142883337|SUPERIORITY|||||||0.459|||||||t-test, 2 sided|||||||0.459
71682548|NCT00224406|142883367|SUPERIORITY||Mean Difference (Final Values)|5.022||||0.8541|ONE_SIDED|95.0||50.26|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at ICU Admission (Time 0).||50.26||0.8541
71682549|NCT00224406|142883367|SUPERIORITY||Mean Difference (Final Values)|10.426||||0.6996|ONE_SIDED|95.0||55.17|||t-test, 1 sided|||Repeated Measurements Analysis of PaO2/FiO2 ratio corrected for the altitude at 0 and 24hours after ICU admission using a one-sided test excluding missing data. Herein analysis at 24 Hours Post ICU Admission.||55.17||0.6996
71682550|NCT00224406|142883368|SUPERIORITY||Mean Difference (Final Values)|4.377||||0.8654|ONE_SIDED|95.0||47.15|||t-test, 1 sided|||ICU Admission (Time 0)||47.15||0.8654
71682551|NCT00224406|142883368|SUPERIORITY||Median Difference (Final Values)|13.386||||0.6789|ONE_SIDED|95.0||66.91|||t-test, 1 sided|||24 Hours Post ICU Admission||66.91||0.6789
71682552|NCT00224406|142883368|SUPERIORITY||Mean Difference (Final Values)|-19.968||||0.6345|ONE_SIDED|95.0||49.56|||t-test, 1 sided|||48 Hours Post ICU Admission||49.56||0.6345
71682553|NCT00224406|142883368|SUPERIORITY||Mean Difference (Final Values)|0.908||||0.9858|ONE_SIDED|95.0||85.49|||t-test, 1 sided|||72 Hours Post ICU Admission||85.49||0.9858
71865818|NCT02187159|143247125|SUPERIORITY||Difference in least squares means|-0.009|STANDARD_ERROR_OF_MEAN|0.0248||0.7034|TWO_SIDED|95.0|-0.058|0.039|||ANCOVA|||||0.039|-0.058|0.7034
71865819|NCT02187159|143247125|SUPERIORITY||Difference in least squares means|-0.02|STANDARD_ERROR_OF_MEAN|0.0249||0.4143|TWO_SIDED|95.0|-0.069|0.028|||ANCOVA|||||0.028|-0.069|0.4143
71865820|NCT02187159|143247125|SUPERIORITY||Difference in least squares means|0.005|STANDARD_ERROR_OF_MEAN|0.0249||0.8365|TWO_SIDED|95.0|-0.044|0.054|||ANCOVA|||||0.054|-0.044|0.8365
71865821|NCT02187159|143247125|SUPERIORITY||Difference in least squares means|-0.006|STANDARD_ERROR_OF_MEAN|0.0249||0.8189|TWO_SIDED|95.0|-0.055|0.043|||ANCOVA|||||0.043|-0.055|0.8189
71865822|NCT00567567|143247126|SUPERIORITY_OR_OTHER_LEGACY||Log Rank Test Statistic|6.9883||||0.0082|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.||||0.0082
71865823|NCT00567567|143247127|SUPERIORITY_OR_OTHER_LEGACY||Chi-squared test statistic|8.5751||||0.0034|TWO_SIDED|95.0|||||Chi-squared|||Chi-square test of proportions in all patients to compare the proportion of responders (complete response \[CR\]+ very good partial response \[VGPR\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.||||0.0034
71865824|NCT00567567|143247128|SUPERIORITY_OR_OTHER_LEGACY||Gray's test statistic|0.33709||||0.5615|TWO_SIDED|95.0|||||Gray's test for competing risks|||The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.||||0.5615
71865825|NCT00567567|143247129|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.0557||||0.0939|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.0939
71865826|NCT00567567|143247130|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.0543||||0.3277|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.3277
71865827|NCT00567567|143247131|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4328||||0.7598|TWO_SIDED|95.0|0.4105|5.001|||Fisher Exact|Fisher's exact test was used instead of chi-square test due to small expected cell counts.||Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population||5.001|0.4105|0.7598
71865828|NCT00567567|143247135|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.015||||0.6853|TWO_SIDED|95.0|||||Regression, Cox|||The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.||||0.6853
71865829|NCT03268603|143247147|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71865830|NCT04514510|143247159|SUPERIORITY|||||||0.64|||||||ANCOVA with Multiple Imputation|||||||0.64
71865831|NCT04514510|143247165|SUPERIORITY|||||||0.149|||||||Wilcoxon (Mann-Whitney)|||||||0.149
71865832|NCT00406692|143247169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.0003|TWO_SIDED|95.0||||Null Hypothesis: No difference in the mean daily standard drinks consumed for the baseline period and the zonisamide treatment weeks|Mixed Models Analysis|||Null Hypothesis: No difference in the mean daily standard drinks consumed between the baseline period and the zonisamide treatment weeks.||||<0.0003
71865833|NCT00406692|143247170|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.7|STANDARD_ERROR_OF_MEAN|3.9|<|0.22|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant change in the mean number of words produced during phonetic portion of the Controlled Word Association Test between the baseline period and the treatment weeks.||||<0.22
71865834|NCT00406692|143247171|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|4.0|<|0.55|TWO_SIDED|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant difference for mean scores obtained for baseline, week 4 and week 12.||||< 0.55
71865835|NCT01145898|143247172|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANCOVA|||There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.||||.6261
71865836|NCT01145898|143247173|SUPERIORITY_OR_OTHER|||||||0.6081||95.0|||||ANCOVA|||||||.6081
71865837|NCT01145898|143247174|SUPERIORITY_OR_OTHER|||||||0.1822||95.0|||||ANCOVA|||||||.1822
71865838|NCT01145898|143247175|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
71865839|NCT01145898|143247176|SUPERIORITY_OR_OTHER|||||||0.2383||95.0|||||ANCOVA|||||||.2383
71865840|NCT01145898|143247177|SUPERIORITY_OR_OTHER|||||||0.1564||95.0|||||ANCOVA|||||||.1564
71865841|NCT01145898|143247178|SUPERIORITY_OR_OTHER|||||||0.2265||95.0|||||ANCOVA|||||||.2265
71865842|NCT01145898|143247179|SUPERIORITY_OR_OTHER|||||||0.4645||95.0|||||ANCOVA|||||||.4645
71865843|NCT01145898|143247180|SUPERIORITY_OR_OTHER|||||||0.5998||95.0|||||ANCOVA|||||||.5998
71865844|NCT01145898|143247181|SUPERIORITY_OR_OTHER|||||||0.8119||95.0|||||ANCOVA|||||||.8119
71865845|NCT01145898|143247182|SUPERIORITY_OR_OTHER|||||||0.1319||95.0|||||ANCOVA|||||||.1319
71865846|NCT01145898|143247183|SUPERIORITY_OR_OTHER|||||||0.0199||95.0|||||ANCOVA|||||||.0199
71865847|NCT01145898|143247184|SUPERIORITY_OR_OTHER|||||||0.7597||95.0|||||ANCOVA|||||||.7597
71865848|NCT01145898|143247185|SUPERIORITY_OR_OTHER|||||||0.2528||95.0|||||ANCOVA|||||||.2528
71865849|NCT00403767|143247219|NON_INFERIORITY_OR_EQUIVALENCE|Alternative hypothesis of non-inferiority (NI) by a NI margin of 1.46 in hazard ratio (HR) based on on-treatment data from the per protocol population. The required number of primary efficacy endpoint events was determined based on the following assumptions: NI margin of 1.46, 1-sided alpha of 0.025, power of \>95% when true HR is 1, and exponential distributions. The margin was selected based on clinical appropriateness and quantitative analysis of relevant studies in Hart et al.|Hazard Ratio (HR)|0.79|||<|0.001|TWO_SIDED|95.0|0.66|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.025 (1-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||||0.96|0.66|<0.001
71682554|NCT00224406|142883369|SUPERIORITY||Odds Ratio (OR)|2.867||||0.7985|TWO_SIDED|95.0|0.727|11.302|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at ICU Admission (Time 0). One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||11.302|0.727|0.7985
71682555|NCT00224406|142883369|SUPERIORITY||Odds Ratio (OR)|0.837||||0.5606|TWO_SIDED|95.0|0.226|3.092|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 24h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||3.092|0.226|0.5606
71865850|NCT00403767|143247220|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.015|TWO_SIDED|95.0|0.65|0.95||The p-value Is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.95|0.65|0.015
71911076|NCT01468701|143342941|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.57|1.11|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.11|0.57|
71682556|NCT00224406|142883369|SUPERIORITY||Odds Ratio (OR)|1.716||||0.8786|TWO_SIDED|95.0|0.531|5.552|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 48h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.552|0.531|0.8786
71911077|NCT01468701|143342943|OTHER||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.57|1.14|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||1.14|0.57|
71682557|NCT00224406|142883369|SUPERIORITY||Odds Ratio (OR)|1.337||||0.8499|TWO_SIDED|95.0|0.352|5.072|||Cochran-Mantel-Haenszel||Odds ratio is Repertaxin:Placebo ratio of PGD scores 0-2:PGD score 3 odds|Analysis of PGD score was performed separately at time 0, and at 24, 48, 72 hours after ICU admission. Herein analysis at 72h post-ICU admission. One patient of placebo group is excluded from analysis of PGD score because the cause of graft dysfunction is Cardiogenic pulmonary edema.||5.072|0.352|0.8499
71865851|NCT00403767|143247221|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.442|TWO_SIDED|95.0|0.96|1.11||The p-value is not adjusted for mulitple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternate hypothesis of superiority based on on-treatment data from the safety population.||1.11|0.96|0.442
71865852|NCT00403767|143247222|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.034|TWO_SIDED|95.0|0.74|0.99||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.99|0.74|0.034
71911078|NCT01468701|143342951|OTHER||Hazard Ratio (HR)|0.52|||||TWO_SIDED|95.0|0.38|0.73|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.||0.73|0.38|
71911079|NCT01468701|143342955|OTHER||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.6|1.57|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.||1.57|0.60|
71911080|NCT01468701|143342957|OTHER||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.54|0.8|||Regression, Cox||Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).|A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.||0.80|0.54|
71865853|NCT00403767|143247223|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.01|TWO_SIDED|95.0|0.74|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.96|0.74|0.010
71911081|NCT01068717|143342960|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric least squares (LS) mean|109.53|||||TWO_SIDED|90.0|102.67|116.85||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||116.85|102.67|
71865854|NCT00403767|143247224|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.092|TWO_SIDED|95.0|0.7|1.03||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.03|0.70|0.092
71865855|NCT00403767|143247225|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.23||||0.003|TWO_SIDED|95.0|0.09|0.61||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||0.61|0.09|0.003
71865856|NCT00403767|143247226|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.121|TWO_SIDED|95.0|0.63|1.06||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.06|0.63|0.121
71865857|NCT00403767|143247227|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.289|TWO_SIDED|95.0|0.73|1.1||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.10|0.73|0.289
71865858|NCT00403767|143247228|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.073|TWO_SIDED|95.0|0.7|1.02||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.||1.02|0.70|0.073
71865859|NCT02206061|143247242|OTHER|Repeated measure analyses testing the overall treatment effect were performed by fitting the Generalized Estimating Equation (GEE) with SFD at the three follow-up time points (3, 5, 7 months) as the dependent variable and treatment as independent variable. Normal error and identity link was specified and standard error was calculated using Sandwich estimator. Baseline SFDs, poverty level, and the presence of smokers in the home were controlled in the regression model.|Mean Difference (Net)|0.9|STANDARD_DEVIATION|2.6|<|0.05|TWO_SIDED||||||Regression, Linear|||||||<.05
71865860|NCT02193490|143247265|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71865861|NCT02193490|143247266|OTHER|||||||0.078|||||||Kruskal-Wallis|||||||0.078
71865862|NCT02193490|143247267|OTHER||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71865863|NCT02628028|143247282|SUPERIORITY|||||||0.473|||||||Regression, Logistic|||||||0.473
71865864|NCT02628028|143247282|SUPERIORITY|||||||0.67|||||||Regression, Logistic|||||||0.670
71922208|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-4.73|STANDARD_ERROR_OF_MEAN|2.73|||TWO_SIDED|95.0|-10.4|0.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||0.93|-10.40|
71682558|NCT00224406|142883370|SUPERIORITY|at 24 hrs from mechanical ventilation|difference in event probability|0.0091||||0.7076|TWO_SIDED|95.0|-0.1867|0.2049|||Log Rank|||||0.2049|-0.1867|0.7076
71865865|NCT02628028|143247282|SUPERIORITY|||||||0.823|||||||Regression, Logistic|||||||0.823
71865866|NCT02628028|143247283|SUPERIORITY|||||||0.743|||||||Regression, Logistic|||||||0.743
71865867|NCT02628028|143247283|SUPERIORITY|||||||0.124|||||||Regression, Logistic|||||||0.124
71865868|NCT02628028|143247283|SUPERIORITY|||||||0.858|||||||Regression, Logistic|||||||0.858
71865869|NCT02628028|143247284|SUPERIORITY|||||||0.199|||||||Regression, Logistic|||||||0.199
71865870|NCT02628028|143247284|SUPERIORITY|||||||0.028|||||||Regression, Logistic|||||||0.028
71865871|NCT02628028|143247284|SUPERIORITY|||||||0.863|||||||Regression, Logistic|||||||0.863
71865872|NCT02628028|143247285|SUPERIORITY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.863|TWO_SIDED|95.0|-0.53|0.44|||Mixed-effects Model for Repeated Measure|||||0.44|-0.53|0.863
71865873|NCT02628028|143247285|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.503|TWO_SIDED|95.0|-0.32|0.65|||Mixed-effects Model for Repeated Measure|||||0.65|-0.32|0.503
71865874|NCT02628028|143247285|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.25||0.289|TWO_SIDED|95.0|-0.77|0.23|||Mixed-effects Model for Repeated Measure|||||0.23|-0.77|0.289
71865875|NCT02628028|143247286|SUPERIORITY|||||||0.626|||||||Regression, Logistic|||||||0.626
71865876|NCT02628028|143247286|SUPERIORITY|||||||0.418|||||||Regression, Logistic|||||||0.418
71865877|NCT02628028|143247286|SUPERIORITY|||||||0.951|||||||Regression, Logistic|||||||0.951
71865878|NCT02628028|143247287|SUPERIORITY|||||||0.905|||||||Regression, Logistic|||||||0.905
71865879|NCT02628028|143247287|SUPERIORITY|||||||0.069|||||||Regression, Logistic|||||||0.069
71865880|NCT02628028|143247287|SUPERIORITY|||||||0.547|||||||Regression, Logistic|||||||0.547
71865881|NCT02145468|143247289|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.238|TWO_SIDED|95.0|0.91|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.47|0.91|0.238
71865882|NCT02145468|143247290|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.38|||Log Rank||"Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk.~with the treatment compared with placebo."|||1.38|0.90|0.329
71865883|NCT02145468|143247291|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.338|TWO_SIDED|95.0|0.88|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.88|0.338
71922209|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-5.1|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-12.06|1.86|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||1.86|-12.06|
71682559|NCT00224406|142883370|SUPERIORITY||difference in event probability|-0.0316||||0.7076|TWO_SIDED|95.0|-0.2092|0.146|||Log Rank|||at 48 hrs from mechanical ventilation||0.1460|-0.2092|0.7076
71682560|NCT00224406|142883370|SUPERIORITY||difference in event probability|-0.0661||||0.7076|TWO_SIDED|95.0|-0.2314|0.0993|||Log Rank|||at 72 hrs from mechanical ventilation||0.0993|-0.2314|0.7076
71865884|NCT02145468|143247291|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.41|TWO_SIDED|95.0|0.88|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.88|0.410
71865885|NCT02145468|143247292|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.472|TWO_SIDED|95.0|0.86|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death, MI or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.38|0.86|0.472
71865886|NCT02145468|143247293|SUPERIORITY||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.91|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of arterial CV events (CV death, MI, SRI-UR or stroke), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.91|
71865887|NCT02145468|143247294|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.505|TWO_SIDED|95.0|0.86|1.36|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of coronary events (CHD death, MI, SRI-UR or any unplanned coronary artery revascularization), Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.36|0.86|0.505
71865888|NCT02145468|143247295|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.536|TWO_SIDED|95.0|0.64|1.26|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.26|0.64|0.536
71865889|NCT02145468|143247295|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6|TWO_SIDED|95.0|0.69|1.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.24|0.69|0.6
71865890|NCT02145468|143247296|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.356|TWO_SIDED|95.0|0.88|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI or stroke, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.88|0.356
71865891|NCT02145468|143247297|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.329|TWO_SIDED|95.0|0.9|1.39|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI, SRI-UR, stroke or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.39|0.9|0.329
71865892|NCT02145468|143247298|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.285|TWO_SIDED|95.0|0.89|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death, MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.47|0.89|0.285
71865893|NCT02145468|143247299|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.401|TWO_SIDED|95.0|0.86|1.46|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.46|0.86|0.401
71682561|NCT00224406|142883371|SUPERIORITY||Difference in event probability|-0.0364||||0.9632|TWO_SIDED|95.0|-0.0858|0.0131|||Log Rank|||Analysis at 24 hours||0.0131|-0.0858|0.9632
71682562|NCT00224406|142883371|SUPERIORITY||Difference in event probability|0.0352||||0.9632|TWO_SIDED|95.0|-0.1458|0.2162|||Log Rank|||Analysis at 48 h||0.2162|-0.1458|0.9632
71682563|NCT00224406|142883371|SUPERIORITY||Difference in event probability|-0.0179||||0.9632|TWO_SIDED|95.0|-0.2143|0.1785|||Log Rank|||analysis at 72 h||0.1785|-0.2143|0.9632
71865894|NCT02145468|143247300|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.295|TWO_SIDED|95.0|0.89|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death, MI or SRI-UR,Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.44|0.89|0.295
71865895|NCT02145468|143247301|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.412|TWO_SIDED|95.0|0.86|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.43|0.86|0.412
71865896|NCT02145468|143247302|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469|TWO_SIDED|95.0|0.83|1.49|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, type I (spontaneous) MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.49|0.83|0.469
71865897|NCT02145468|143247303|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.664|TWO_SIDED|95.0|0.78|1.48|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or type I (spontaneous) MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.48|0.78|0.664
71865898|NCT02145468|143247304|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.13|TWO_SIDED|95.0|0.27|1.19|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with first occurrence of definite or probable stent thrombosis, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.19|0.27|0.130
71865899|NCT02145468|143247305|SUPERIORITY||Odds Ratio (OR)|1.03||||0.744|TWO_SIDED|95.0|0.84|1.27|||Wald chi-squared||Odds ratio is estimated using a logistic regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. An odds ratio \<1 indicates a lower risk with the treatment compared with placebo.|||1.27|0.84|0.744
71865900|NCT02145468|143247306|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.309|TWO_SIDED|95.0|0.53|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Participants with all-cause mortality, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.53|0.309
71865901|NCT02145468|143247307|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.398|TWO_SIDED|95.0|0.53|1.28|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.28|0.53|0.398
71865902|NCT02145468|143247307|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.264|TWO_SIDED|95.0|0.55|1.18|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.18|0.55|0.264
71865903|NCT02145468|143247308|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.251|TWO_SIDED|95.0|0.47|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|CHD death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.22|0.47|0.251
71865904|NCT02145468|143247309|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.182|TWO_SIDED|95.0|0.91|1.67|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.67|0.91|0.182
71865905|NCT02145468|143247309|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.158|TWO_SIDED|95.0|0.93|1.58|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.58|0.93|0.158
71865906|NCT02145468|143247310|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.21|TWO_SIDED|95.0|0.85|2.12|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Type I (spontaneous) MI events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.12|0.85|0.21
71865907|NCT02145468|143247311|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.697|TWO_SIDED|95.0|0.58|2.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|SRI-UR events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||2.24|0.58|0.697
71865908|NCT02145468|143247312|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.883|TWO_SIDED|95.0|0.46|1.96|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Stroke (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.96|0.46|0.883
71865909|NCT02145468|143247313|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.457|TWO_SIDED|95.0|0.54|1.32|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.32|0.54|0.457
71865910|NCT02145468|143247313|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.736|TWO_SIDED|95.0|0.63|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24||1.38|0.63|0.736
71865911|NCT02145468|143247314|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.581|TWO_SIDED|95.0|0.77|1.59|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio \<1 indicates a lower risk with the treatment compared with placebo.|Any unplanned coronary revascularization, Placebo Vs Losmapimod 7.5 mg BID at Week 12||1.59|0.77|0.581
71865912|NCT04157400|143247315|OTHER||||||<|0.01|||||||Kruskal-Wallis|||||||<0.01
71865913|NCT04157400|143247316|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71922210|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-2.96|STANDARD_ERROR_OF_MEAN|3.33|||TWO_SIDED|95.0|-9.87|3.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||3.96|-9.87|
71682564|NCT00224406|142883376|SUPERIORITY||Difference in event probability|-0.0566||||0.0111|TWO_SIDED|95.0|-0.1188|0.0056|||Log Rank|||Herein analysis up to month 3 was reported.||0.0056|-0.1188|0.0111
71922211|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|0.87|STANDARD_ERROR_OF_MEAN|2.69|||TWO_SIDED|95.0|-4.7|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.45|-4.70|
71682565|NCT00224406|142883376|SUPERIORITY||Difference in event probability|-0.0943||||0.0111|TWO_SIDED|95.0|-0.173|-0.0156|||Log Rank|||Herein analysis up to month 6 was reported.||-0.0156|-0.1730|0.0111
71682566|NCT00224406|142883376|SUPERIORITY||Difference in event probability|-0.1132||||0.0111|TWO_SIDED|95.0|-0.1985|-0.0279|||Log Rank|||Herein analysis up to month 9 was reported.||-0.0279|-0.1985|0.0111
71865914|NCT04157400|143247317|OTHER||||||||||||||||||Segments of EMG recorded during walking at self-selected walking speed were used to investigate complexity of muscle synergies using a nonnegative matrix factorization (NNMF) algorithm (MATLAB®, Mathworks, Natick, MA). The approach involves calculation of an mxt matrix of the original EMG data (EMG0), where m represents the number of muscles being measured and t represents a time base normalized to percentage of gait cycle. The algorithm also calculates two surrogate matrices, mxn and nxt, where n is the amplitude of muscle activation. The product of the surrogate matrices are considered a reconstruction of EMG (EMGr). EMGr for each module is then compared to EMG0 by finding the variability accounted for (VAF). A threshold necessary for module classification was chosen to be 90% for all conditions (8 muscles + 6 phases of gait) based on similar studies in the literature. Classifications were not increased unless the higher module VAF was at least 5% higher than the preceding module.|||
71865915|NCT00186888|143247336|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|88.9|||||TWO_SIDED|95.0|71.3|96.9||||||||96.9|71.3|
71865916|NCT00186888|143247337|SUPERIORITY_OR_OTHER_LEGACY||Binomial Proportion|91.7|||||TWO_SIDED|95.0|65.1|99.6||||||||99.6|65.1|
71865917|NCT00186888|143247338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.452||95.0|||||ANOVA|||CYP3A4\*1B: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.452
71865918|NCT00186888|143247338|SUPERIORITY_OR_OTHER_LEGACY|||||||0.106||95.0|||||ANOVA|||CYP3A5\*3: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.106
71865919|NCT00186888|143247339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0|||||ANOVA|||BCRP 1143: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.245
71911082|NCT01068717|143342960|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.37|||||TWO_SIDED|90.0|85.7|117.56||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||117.56|85.70|
71922212|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|0.55|STANDARD_ERROR_OF_MEAN|2.63|||TWO_SIDED|95.0|-4.9|6.01|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||6.01|-4.90|
71682567|NCT00224406|142883376|SUPERIORITY||Slope|-0.1334||||0.0111|TWO_SIDED|95.0|-0.2254|-0.0413|||Log Rank|||Herein analysis up to month 12 was reported.||-0.0413|-0.2254|0.0111
71865920|NCT00186888|143247339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.297||95.0|||||ANOVA|||BCRP 15622: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.297
71865921|NCT00186888|143247339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||95.0|||||ANOVA|||BCRP Exon 2: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.372
71865922|NCT00186888|143247339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.844||95.0|||||ANOVA|||BCRP Exon 5: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.844
71865923|NCT00186888|143247339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.616||95.0|||||ANOVA|||Pgp Exon 21: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.616
71865924|NCT00186888|143247339|SUPERIORITY_OR_OTHER_LEGACY|||||||0.424||95.0|||||ANOVA|||Pgp Exon 26: The null hypothesis is there is not a statistically significant difference between the genotype groups.||||0.424
71682568|NCT01556997|142883379|SUPERIORITY_OR_OTHER|||||||0.025|ONE_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
71865925|NCT04711837|143247390|NON_INFERIORITY|Non-inferiority margin equals to -8%|Risk Difference (RD)|-0.0057|STANDARD_ERROR_OF_MEAN|0.0246|||TWO_SIDED|95.0|-0.054|0.042||Non-inferiority margin equals to -8%: 95% CI; (-5.4%, 4.2%)|Farrington-Manning method|||||0.042|-0.054|
71865926|NCT02344290|143247433|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.84|||||Hazard ratio is shown as pitavastatin/placebo. Two-sided 95% repeated confidence interval that adjusts for interim looks according to the realized Lan and DeMets implementation of the O'Brien-Fleming sequential stopping boundary is presented.|||0.84|0.48|
71865927|NCT02344290|143247434|SUPERIORITY||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.36|0.87|||||Hazard ratio is shown as pitavastatin/placebo.|||0.87|0.36|
71865928|NCT02344290|143247435|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.4|0.97|||||Hazard ratio is shown as pitavastatin/placebo.|||0.97|0.40|
71865929|NCT02344290|143247436|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.11|4.02|||||Hazard ratio is shown as pitavastatin/placebo.|||4.02|0.11|
71865930|NCT02344290|143247437|SUPERIORITY||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.35|1.38|||||Hazard ratio is shown as pitavastatin/placebo.|||1.38|0.35|
71865931|NCT02344290|143247438|SUPERIORITY||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||Hazard ratio is shown as pitavastatin/placebo.|||1.03|0.44|
71865932|NCT02344290|143247439|SUPERIORITY||Hazard Ratio (HR)|0.62|||||TWO_SIDED|95.0|0.36|1.05|||||||Hazard ratio is shown as pitavastatin/placebo.|1.05|0.36|
71922213|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|-7.22|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.10|-7.22|
71682569|NCT01556997|142883380|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (\<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA|||||||0.025
71865933|NCT02344290|143247441|SUPERIORITY||Hazard Ratio (HR)|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||||Hazard ratio is shown as pitavastatin/placebo. Estimation of the confidence interval used a Bayes analysis with a non-informative prior using adaptive rejection Metropolis sampling. In this case, the interval shown is a 95% highest posterior density (HPD) interval.|0.54|0.00|
71682570|NCT01149421|142883399|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.79|||<|0.001|TWO_SIDED|97.3|-4.58|-1.0||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-1.00|-4.58|<0.001
71865934|NCT02344290|143247442|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.64|0.94|||||Hazard ratio is shown as pitavastatin/placebo.|||0.94|0.64|
71865935|NCT02344290|143247443|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.7|1.12|||||Hazard ratio is shown as pitavastatin/placebo.|||1.12|0.70|
71865936|NCT02344290|143247444|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.76|1.13|||||Hazard ratio is shown as pitavastatin/placebo.|||1.13|0.76|
71865937|NCT02344290|143247445|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.71|1.2|||||Hazard ratio is shown as pitavastatin/placebo.|||1.20|0.71|
71865938|NCT02344290|143247446|SUPERIORITY||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.68|1.31|||||Hazard ratio is shown as pitavastatin/placebo.|||1.31|0.68|
71865939|NCT02344290|143247447|SUPERIORITY||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.14|2.51|||||Hazard ratio is shown as pitavastatin/placebo.|||2.51|0.14|
71865940|NCT02344290|143247448|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.42|2.02|||||Hazard ratio is shown as pitavastatin/placebo.|||2.02|0.42|
71865941|NCT02344290|143247449|SUPERIORITY||Incidence rate ratio|1.0|||||TWO_SIDED|95.0|0.9|1.1|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.10|0.90|
71865942|NCT02344290|143247450|SUPERIORITY||Incidence rate ratio|1.29|||||TWO_SIDED|95.0|1.07|1.57|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.57|1.07|
71865943|NCT02344290|143247451|SUPERIORITY||Incidence rate ratio|1.58|||||TWO_SIDED|95.0|1.14|2.19|||||Incidence rate ratio is shown as pitavastatin/placebo.|||2.19|1.14|
71865944|NCT02344290|143247452|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.17|3.37|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.37|0.17|
71865945|NCT02344290|143247453|SUPERIORITY||Incidence rate ratio|1.34|||||TWO_SIDED|95.0|0.56|3.18|||||Incidence rate ratio is shown as pitavastatin/placebo.|||3.18|0.56|
71865946|NCT02344290|143247454|SUPERIORITY||Incidence rate ratio|1.04|||||TWO_SIDED|95.0|0.97|1.12|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.12|0.97|
71865947|NCT02344290|143247457|SUPERIORITY||Incidence rate ratio|0.75|||||TWO_SIDED|95.0|0.52|1.08|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.08|0.52|
71865948|NCT02344290|143247458|SUPERIORITY||Incidence rate ratio|1.05|||||TWO_SIDED|95.0|0.96|1.16|||||Incidence rate ratio is shown as pitavastatin/placebo.|||1.16|0.96|
71682571|NCT01149421|142883399|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.07|||<|0.001|TWO_SIDED|97.3|-2.83|0.68||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.68|-2.83|<0.001
71911083|NCT01068717|143342961|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.02|||||TWO_SIDED|90.0|91.29|107.41||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states||107.41|91.29|
71911084|NCT01068717|143342961|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.21|||||TWO_SIDED|90.0|96.86|103.67||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.67|96.86|
71911085|NCT01068717|143342963|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
71911086|NCT01068717|143342963|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.78|||||TWO_SIDED|90.0|96.61|103.05||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||103.05|96.61|
71911087|NCT01068717|143342968|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||TWO_SIDED|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||106.91|97.96|
71922214|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-0.47|STANDARD_ERROR_OF_MEAN|3.28|||TWO_SIDED|95.0|-7.27|6.34|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.34|-7.27|
71922215|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|1.72|STANDARD_ERROR_OF_MEAN|2.4|||TWO_SIDED|95.0|-3.26|6.69|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.69|-3.26|
71682572|NCT01149421|142883399|SUPERIORITY_OR_OTHER||||||<|0.001||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||<0.001
71682573|NCT01149421|142883399|SUPERIORITY_OR_OTHER|||||||0.149||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.149
71682574|NCT01149421|142883400|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.66|||<|0.001|TWO_SIDED|97.3|-4.53|-0.79||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||-0.79|-4.53|<0.001
71865949|NCT02344290|143247459|SUPERIORITY||Mean Difference (Net)|-4.3||||0.04|TWO_SIDED|95.0|-8.6|-0.1|||Regression, Linear||Treatment group difference was estimated as baseline-adjusted mean difference in change at year 2, using linear regression.|||-0.1|-8.6|0.04
71865950|NCT02344290|143247460|SUPERIORITY||Risk Ratio (RR)|0.67||||0.003|TWO_SIDED|95.0|0.52|0.88|||Chi-squared||Treatment effect was estimated as relative risk (pitavastatin/placebo), adjusted for presence of NCP at entry.|||0.88|0.52|0.003
71865951|NCT02344290|143247461|SUPERIORITY||Mean Difference (Net)|-4.3|||||TWO_SIDED|95.0|-9.2|0.62|||||Treatment group difference was estimated as baseline-adjusted difference in mean change at year 2, using linear regression.|||0.62|-9.2|
71865952|NCT02344290|143247462|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of LpPla2 Levels at Month 24||||<0.001
71865953|NCT02344290|143247463|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in LpPla2 from Baseline at Month 24||||<0.001
71865954|NCT02344290|143247464|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Comparison of hsCRP Levels at Month 24||||0.02
71865955|NCT02344290|143247465|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in hsCRP from Baseline at Month 24||||0.09
71865956|NCT02344290|143247466|SUPERIORITY|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Comparison of soluble CD163 Levels at Month 24.||||0.65
71865957|NCT02344290|143247467|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Comparison of Change in soluble CD163 from Baseline at Month 24||||0.88
71865958|NCT02344290|143247468|SUPERIORITY|||||||0.98|||||||Regression, Cox|Treatment effect modification by sex was evaluated via interaction of treatment and sex in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by sex (i.e. pitavastatin effect differing in females compared to males).||||0.98
71865959|NCT02344290|143247468|SUPERIORITY||Hazard Ratio (HR)|0.63|||||TWO_SIDED|95.0|0.39|1.04|||||Hazard ratio is shown as pitavastatin/placebo among females.|Evaluation of pitavastatin effect among females.||1.04|0.39|
71865960|NCT02344290|143247468|SUPERIORITY||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.48|0.86|||||Hazard ratio is shown as pitavastatin/placebo among males.|Evaluation of pitavastatin effect among males.||0.86|0.48|
71865961|NCT02344290|143247469|SUPERIORITY|||||||0.14|||||||Regression, Cox|Treatment effect modification by race was evaluated via interaction of treatment and race in the Cox proportional hazards regression model.||Evaluation of treatment effect modification by race (i.e. pitavastatin effect differing between races).||||0.14
71865962|NCT02344290|143247469|SUPERIORITY||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.09|0.59||||||Pitavastatin effect among Asians from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Asians.|0.59|0.09|
71865963|NCT02344290|143247469|SUPERIORITY||Hazard Ratio (HR)|0.66|||||TWO_SIDED|95.0|0.46|0.96|||||Hazard ratio is shown as pitavastatin/placebo among Blacks.|Pitavastatin effect among Blacks from subgroup analysis by race.||0.96|0.46|
71865964|NCT02344290|143247469|SUPERIORITY||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.49|1.13|||||Hazard ratio is shown as pitavastatin/placebo among Whites.|Pitavastatin effect among Whites from subgroup analysis by race.||1.13|0.49|
71865965|NCT02344290|143247469|SUPERIORITY||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.36|2.1||||||Pitavastatin effect among Other race from subgroup analysis by race.|Hazard ratio is shown as pitavastatin/placebo among Other race.|2.10|0.36|
71865966|NCT03826030|143247492|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||The null hypothesis was no overall difference in FM-UE scale change between the three groups on day 15. The change in FM-UE was modelled using a linear mixed-effects repeated measures model adjusted for visit (ie, day 15, day 45, and day 105), treatment group, treatment group by visit interaction, baseline FM-UE, time from stroke (30-90 vs. 91-180 days), and enrolment site. An AR(1) autocorrelation structure was used for visit, and variance components structure for sites.||||0.39
71865967|NCT05014568|143247496|SUPERIORITY||Risk Ratio, log|2.6|||<|0.0001|TWO_SIDED|95.0|1.66|4.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|H0: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is equal between tapinarof cream, 1% and vehicle cream; H1: The proportion of subjects who achieve a vIGA-AD score of clear (0) or almost clear (1) and at least a 2-grade reduction from Baseline at Week 8 is different between the tapinarof cream, 1% and vehicle cream.||4.09|1.66|<0.0001
71865968|NCT05014568|143247497|SUPERIORITY||Risk Ratio, log|2.17|||<|0.0001|TWO_SIDED|95.0|1.57|3.0|||Cochran-Mantel-Haenszel|Stratified by vIGA-AD score at Baseline (vIGA-AD scores of 3 or 4) and age group (2-6 yrs, 7-11 yrs, 12-17 yrs, 18+ yrs)|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||3.00|1.57|<0.0001
71922216|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|0.25|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-4.69|5.2|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||5.20|-4.69|
71865969|NCT05014568|143247498|SUPERIORITY||Least squares mean difference|-6.17|STANDARD_ERROR_OF_MEAN|0.657|<|0.0001|TWO_SIDED|95.0|-7.69|-4.66|||ANCOVA|age\*vIGA cohort and treatment as categorical covariates, and baseline %BSA as a continuous covariate||||-4.66|-7.69|<0.0001
71865970|NCT05014568|143247499|SUPERIORITY||Risk Ratio, log|3.74|||<|0.0001|TWO_SIDED|95.0|1.98|7.09|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||7.09|1.98|<0.0001
71865971|NCT05014568|143247500|SUPERIORITY||Risk Ratio, log|1.54||||0.0366|TWO_SIDED|95.0|1.03|2.31|||Cochran-Mantel-Haenszel|Stratified by Baseline vIGA-AD Score and Age Group|Adjusted logit-based estimate of the common relative risk of success (Tapinarof Cream 1%/Vehicle Cream) over all strata. Multiple imputation p-value is for null hypothesis that the log (Relative Risk) equals 0.|||2.31|1.03|0.0366
71865972|NCT04893460|143247501|SUPERIORITY|This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Cost activity|Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|0.33||0.003|TWO_SIDED||||||t-test, 2 sided|||||||.003
71922217|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-4.43|STANDARD_ERROR_OF_MEAN|1.96|||TWO_SIDED|95.0|-8.5|-0.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.36|-8.50|
71922218|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-4.17|STANDARD_ERROR_OF_MEAN|1.99|||TWO_SIDED|95.0|-8.3|-0.03|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||-0.03|-8.30|
71865973|NCT04893460|143247501|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.44|<|0.001|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Quit Letter activity||||<.001
71865974|NCT04893460|143247501|SUPERIORITY||Mean Difference (Final Values)|-1.44|STANDARD_ERROR_OF_MEAN|0.41||0.004|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Pitfalls activity||||.004
71865975|NCT04893460|143247501|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.48||0.098|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Smoke Free activity||||.098
71865976|NCT04893460|143247501|SUPERIORITY||Mean Difference (Final Values)|-1.46|STANDARD_ERROR_OF_MEAN|0.68||0.042|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to after the Letter to Youth activity||||.042
71865977|NCT04893460|143247501|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.22||0.364|TWO_SIDED||||||t-test, 2 sided|||This model is a paired t-test that tests for change in cognitive dissonance from baseline to 6 weeks post baseline.||||.364
71865978|NCT04893460|143247502|SUPERIORITY||median pairwise average|17.67|||<|0.001|TWO_SIDED||||||Wilcoxson Signed Rank Test|||The non-parametric Wilcoxon signed-rank test was used to evaluate whether participants were smoking fewer cigarettes per day.||||<.001
71865979|NCT04893460|143247503|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Cost activity|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.42||0.776|TWO_SIDED||||||t-test, 2 sided|||||||.776
71865980|NCT04893460|143247503|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Quit Latter activity|Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.45||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
71865981|NCT04893460|143247503|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Pitfalls activity|Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.55||0.043|TWO_SIDED||||||t-test, 2 sided|||||||.043
71865982|NCT04893460|143247503|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Smoke Free activity|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.67||0.219|TWO_SIDED||||||t-test, 2 sided|||||||.219
71865983|NCT04893460|143247503|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to after the Letter to Youth activity|Mean Difference (Final Values)|-1.41|STANDARD_ERROR_OF_MEAN|0.54||0.11|TWO_SIDED||||||t-test, 2 sided|||||||.110
71865984|NCT04893460|143247503|SUPERIORITY|This model is a paired t-test that tests for change in readiness to quit smoking from baseline to 6 week post baseline assessment|Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.26||0.868|TWO_SIDED||||||t-test, 2 sided|||||||.868
71865985|NCT05718466|143247587|SUPERIORITY|||||||0.11|||||||Log Rank|||||||0.11
71865986|NCT05718466|143247588|SUPERIORITY|||||||0.001|||||||Log Rank|||||||0.001
71865987|NCT01325311|143247600|SUPERIORITY_OR_OTHER|||||||0.922|TWO_SIDED||||||t-test, 2 sided|||Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.||||0.922
71682575|NCT01149421|142883400|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.71|||<|0.001|TWO_SIDED|97.3|-3.54|0.12||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||0.12|-3.54|<0.001
71865988|NCT01732822|143247615|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.65|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.650
71865989|NCT01732822|143247616|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.738|TWO_SIDED|95.0|0.92|1.12||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.12|0.92|0.738
71865990|NCT01732822|143247617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.4|TWO_SIDED|95.0|0.92|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.92|0.400
71865991|NCT01732822|143247618|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.482|TWO_SIDED|95.0|0.91|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.23|0.91|0.482
71865992|NCT01732822|143247619|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.913|TWO_SIDED|95.0|0.89|1.11||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.11|0.89|0.913
71865993|NCT01732822|143247620|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.724|TWO_SIDED|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.13|0.92|0.724
71682576|NCT01149421|142883400|SUPERIORITY_OR_OTHER|||||||0.002||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.002
71682577|NCT01149421|142883400|SUPERIORITY_OR_OTHER|||||||0.36||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.36
71865994|NCT01732822|143247621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.846|TWO_SIDED|95.0|0.79|1.33||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.33|0.79|0.846
71865995|NCT01732822|143247622|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.298|TWO_SIDED|95.0|0.87|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.87|0.298
71865996|NCT01732822|143247623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.462|TWO_SIDED|95.0|0.9|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.05|0.90|0.462
71865997|NCT01732822|143247624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.793|TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|||||1.12|0.92|0.793
71865998|NCT01732822|143247625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.92|1.09|||Regression, Cox|||||1.09|0.92|1.000
71865999|NCT01732822|143247626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.829|TWO_SIDED|95.0|0.91|1.08|||Regression, Cox|||||1.08|0.91|0.829
71866000|NCT01732822|143247627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.949|TWO_SIDED|95.0|0.92|1.08|||Regression, Cox|||||1.08|0.92|0.949
71866001|NCT01732822|143247628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.377|TWO_SIDED|95.0|0.78|1.1|||Regression, Cox|||||1.10|0.78|0.377
71866002|NCT01732822|143247632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.164|TWO_SIDED|95.0|0.71|1.06|||Regression, Cox|||||1.06|0.71|0.164
71866003|NCT01732822|143247633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.306|TWO_SIDED|95.0|0.67|1.14|||Regression, Cox|||||1.14|0.67|0.306
71911088|NCT01068717|143342968|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|101.82|||||TWO_SIDED|90.0|96.1|107.88||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.88|96.10|
71922219|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-3.39|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|95.0|-9.82|3.04|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||3.04|-9.82|
71682578|NCT01149421|142883401|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.32|||<|0.001|TWO_SIDED|97.3|-0.8|1.43||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.43|-0.80|<0.001
71866004|NCT01732822|143247634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.887|TWO_SIDED|95.0|0.93|1.09|||Regression, Cox|||||1.09|0.93|0.887
71866005|NCT01732822|143247635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.489|TWO_SIDED|95.0|0.84|1.43|||Regression, Cox|||||1.43|0.84|0.489
71866006|NCT01732822|143247636|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.138|TWO_SIDED|95.0|0.95|1.43|||Regression, Cox|||||1.43|0.95|0.138
71866007|NCT01732822|143247637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.139|TWO_SIDED|95.0|0.95|1.41|||Regression, Cox|||||1.41|0.95|0.139
71866008|NCT01732822|143247638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58|||<|0.001|TWO_SIDED|95.0|1.24|2.0|||Regression, Cox|||||2.00|1.24|<0.001
71866009|NCT00384774|143247647|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Headache Response||||1.0000
71866010|NCT00384774|143247647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0991|||||||Fisher Exact|||Headache Response||||0.0991
71866011|NCT00384774|143247647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4851|||||||Chi-squared|||Headache Response||||0.4851
71866012|NCT00384774|143247647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1178|||||||Chi-squared|||Headache Response||||0.1178
71866013|NCT00384774|143247647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1093|||||||Chi-squared|||Headache Response||||0.1093
71866014|NCT00384774|143247647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3364|||||||Fisher Exact|||Headache Response||||0.3364
71866015|NCT02815579|143247662|SUPERIORITY||Difference in log odds|-0.08||||0.86|TWO_SIDED|95.0|-1.0|0.84|||Mixed Models Analysis|||The investigators produced a difference-in-difference estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.84|-1.0|0.86
71866016|NCT02815579|143247663|SUPERIORITY||Difference in log odds|0.32||||0.23|TWO_SIDED|95.0|-0.28|0.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.92|-0.28|0.23
71866017|NCT02815579|143247664|SUPERIORITY||Mean Difference (Net)|1.39||||0.26|TWO_SIDED|95.0|-1.01|3.78|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||3.78|-1.01|0.26
71866018|NCT02815579|143247665|SUPERIORITY||Difference in log odds|0.84||||0.31|TWO_SIDED|95.0|-0.79|2.47|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||2.47|-0.79|0.31
71866019|NCT02815579|143247666|SUPERIORITY||Difference in log odds|-0.34||||0.44|TWO_SIDED|95.0|-1.22|0.53|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||0.53|-1.22|0.44
71866020|NCT02815579|143247667|SUPERIORITY||Mean Difference (Net)|-3.54|||<|0.001|TWO_SIDED|95.0|-4.16|-2.92|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-2.92|-4.16|<0.001
71866021|NCT02815579|143247668|SUPERIORITY||Mean Difference (Net)|-0.21||||0.02|TWO_SIDED|95.0|-0.39|-0.04|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.04|-0.39|0.02
71866022|NCT02815579|143247669|SUPERIORITY||Mean Difference (Net)|0.01||||0.98|TWO_SIDED|95.0|-0.82|0.84|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||0.84|-0.82|0.98
71866023|NCT02815579|143247670|SUPERIORITY||Mean Difference (Net)|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2.||-0.15|-0.59|0.001
71866024|NCT02815579|143247671|SUPERIORITY||Difference in log odds|-0.83||||0.001|TWO_SIDED|95.0|-1.45|-0.2|||Mixed Models Analysis|||The investigators analyzed longitudinal data measured every 6 months to assess trends in the two study arms and produced a difference-in-differences estimate between baseline and year 2 using multi-level logistic regression. Units are in log odds.||-0.20|-1.45|0.001
71866025|NCT02815579|143247672|SUPERIORITY||Mean Difference (Net)|-0.42|||<|0.001|TWO_SIDED|95.0|-0.52|-0.31|||Mixed Models Analysis|||||-0.31|-0.52|<0.001
71911089|NCT01068717|143342969|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|102.64|||||TWO_SIDED|90.0|98.31|107.16||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||107.16|98.31|
71911090|NCT01068717|143342969|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|99.22||||||90.0|96.48|102.04||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||102.04|96.48|
71922220|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.06|STANDARD_ERROR_OF_MEAN|3.11|||TWO_SIDED|95.0|-7.51|5.38|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||5.38|-7.51|
71922221|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-2.82|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-8.12|2.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||2.48|-8.12|
71922222|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|95.0|-6.63|3.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||3.91|-6.63|
71866026|NCT00264303|143247673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.005||95.0|0.08|0.43|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.||||0.43|0.08|0.005
71922223|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.19|STANDARD_ERROR_OF_MEAN|2.97|||TWO_SIDED|95.0|-7.35|4.97|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.97|-7.35|
71866027|NCT00264303|143247674|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.041||95.0|0.01|0.34|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate||||0.34|0.01|0.041
71866028|NCT00264303|143247675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.004||95.0|0.04|0.22|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.||||0.22|0.04|0.004
71866029|NCT00264303|143247676|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.002||95.0|0.06|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.||||0.26|0.06|0.002
71866030|NCT00264303|143247677|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.009||95.0|0.03|0.22|||ANCOVA|ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.||||0.22|0.03|0.009
71866031|NCT00264303|143247678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|||<|0.001||95.0|0.07|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline severity as covariate.||The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg||0.26|0.07|<0.001
71866032|NCT02389452|143247679|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Paired t-test|||||||<0.0001
71866033|NCT02311673|143247697|OTHER||Least Squares (LS) Mean Difference|-0.3||||0.42|TWO_SIDED|95.0|-3.1|2.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-3.1|0.420
71866034|NCT02311673|143247697|OTHER||LS Mean Difference|-0.4||||0.348|TWO_SIDED|95.0|-2.3|1.6|||Longitudinal mixed analysis of variance|One sided p-value.|A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.348
71866035|NCT02311673|143247697|OTHER||LS Mean Difference|0.8||||0.779|TWO_SIDED|95.0|-1.3|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-1.3|0.779
71866036|NCT02311673|143247699|OTHER||LS Mean Difference|21.5||||0.901|TWO_SIDED|95.0|-11.8|54.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.8|-11.8|0.901
71866037|NCT02311673|143247699|OTHER||LS Mean Difference|-3.9||||0.362|TWO_SIDED|95.0|-26.3|18.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.5|-26.3|0.362
71866038|NCT02311673|143247699|OTHER||LS Mean Difference|-3.7||||0.378|TWO_SIDED|95.0|-28.0|20.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||20.5|-28.0|0.378
71866039|NCT02311673|143247700|OTHER||LS Mean Difference|20.6||||0.84|TWO_SIDED|95.0|-20.9|62.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||62.2|-20.9|0.840
71911091|NCT01068717|143342970|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.04|||||TWO_SIDED|95.0|92.9|105.59||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||105.59|92.90|
71922224|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.26|STANDARD_ERROR_OF_MEAN|2.91|||TWO_SIDED|95.0|-7.3|4.77|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||4.77|-7.30|
71866040|NCT02311673|143247700|OTHER||LS Mean Difference|-10.2||||0.236|TWO_SIDED|95.0|-38.7|18.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||18.4|-38.7|0.236
71866041|NCT02311673|143247700|OTHER||LS Mean Difference|-13.4||||0.191|TWO_SIDED|95.0|-44.2|17.4|||Longitudinal mixed analysis of variance|One sided p-value.||||17.4|-44.2|0.191
71866042|NCT02311673|143247701|OTHER||LS Mean Difference|19.5||||0.812|TWO_SIDED|95.0|-24.8|63.8||One sided p-value.|Longitudinal mixed analysis of variance||||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|63.8|-24.8|0.812
71922225|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-5.86|STANDARD_ERROR_OF_MEAN|3.29|||TWO_SIDED|95.0|-12.68|0.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.95|-12.68|
71866043|NCT02311673|143247701|OTHER||LS Mean Difference|-1.3||||0.464|TWO_SIDED|95.0|-29.9|27.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.4|-29.9|0.464
71866044|NCT02311673|143247701|OTHER||LS Mean Difference|-2.6||||0.432|TWO_SIDED|95.0|-33.6|28.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||28.4|-33.6|0.432
71866045|NCT02311673|143247702|OTHER||LS Mean Difference|49.9||||0.988|TWO_SIDED|95.0|6.7|93.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||93.2|6.7|0.988
71682579|NCT01149421|142883401|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.42|||<|0.001|TWO_SIDED|97.3|-0.67|1.52||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.52|-0.67|<0.001
71682580|NCT01149421|142883401|SUPERIORITY_OR_OTHER|||||||0.87||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.870
71682581|NCT01149421|142883401|SUPERIORITY_OR_OTHER|||||||0.915||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.915
71866046|NCT02311673|143247702|OTHER||LS Mean Difference|16.0||||0.859|TWO_SIDED|95.0|-13.7|45.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||45.6|-13.7|0.859
71866047|NCT02311673|143247702|OTHER||LS Mean Difference|22.2||||0.916|TWO_SIDED|95.0|-9.8|54.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||54.3|-9.8|0.916
71866048|NCT02311673|143247703|OTHER||LS Mean Difference|32.7||||0.943|TWO_SIDED|95.0|-8.4|73.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||73.8|-8.4|0.943
71866049|NCT02311673|143247703|OTHER||LS Mean Difference|-4.2||||0.339|TWO_SIDED|95.0|-24.4|16.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||16.1|-24.4|0.339
71866050|NCT02311673|143247703|OTHER||LS Mean Difference|1.1||||0.533|TWO_SIDED|95.0|-25.0|27.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||27.2|-25.0|0.533
71866051|NCT02311673|143247711|OTHER||LS Mean Difference|-0.2||||0.439|TWO_SIDED|95.0|-3.0|2.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.6|-3.0|0.439
71866052|NCT02311673|143247711|OTHER||LS Mean Difference|-0.3||||0.366|TWO_SIDED|95.0|-2.3|1.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.6|-2.3|0.366
71866053|NCT02311673|143247711|OTHER||LS Mean Difference|0.7||||0.744|TWO_SIDED|95.0|-1.4|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-1.4|0.744
71866054|NCT02311673|143247712|OTHER||LS Mean Difference|1.0||||0.883|TWO_SIDED|95.0|-0.7|2.8||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.8|-0.7|0.883
71866055|NCT02311673|143247712|OTHER||LS Mean Difference|-0.2||||0.338|TWO_SIDED|95.0|-1.3|0.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||0.9|-1.3|0.338
71866056|NCT02311673|143247712|OTHER||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-1.6|1.2||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.2|-1.6|0.381
71866057|NCT02311673|143247714|OTHER||LS Mean Difference|1.3||||0.679|TWO_SIDED|95.0|-4.5|7.0||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||7.0|-4.5|0.679
71866058|NCT02311673|143247714|OTHER||LS Mean Difference|0.7||||0.641|TWO_SIDED|95.0|-3.3|4.7||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||4.7|-3.3|0.641
71911092|NCT01068717|143342970|NON_INFERIORITY_OR_EQUIVALENCE|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.77|||||TWO_SIDED|95.0|96.82|109.09||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log\[AUC(INF)\], and log\[AUC(0-T)\] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.||109.09|96.82|
71911093|NCT02758119|143342973|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71911094|NCT01569087|143342983|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
71911095|NCT01602549|143342990|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.965|||||TWO_SIDED|95.0|0.831|1.12|||||Day 1: The adjusted means (AMs) and ratios were estimated using a mixed model (MM) fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 1||1.120|0.831|
71911096|NCT01602549|143342990|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.886|||||TWO_SIDED|95.0|0.763|1.029|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 8||1.029|0.763|
71911097|NCT01602549|143342990|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.937|||||TWO_SIDED|95.0|0.85|1.033|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8: Day 1||1.033|0.850|
71911098|NCT01602549|143342990|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.02|||||TWO_SIDED|95.0|0.89|1.17|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8:Day 1 Placebo||1.170|0.890|
71911099|NCT01602549|143342992|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.864|||||TWO_SIDED|95.0|0.702|1.064|||||Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||1.064|0.702|
71911100|NCT01602549|143342992|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.824|1.257|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||1.257|0.824|
71911101|NCT01602549|143342992|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|1.018|||||TWO_SIDED|95.0|0.889|1.166|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 VS Day 1 GSK962040 50 mg||1.166|0.889|
71911102|NCT01602549|143342992|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|0.865|||||TWO_SIDED|95.0|0.709|1.055|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment\*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 Vs Day 1 Placebo||1.055|0.709|
71911103|NCT01602549|143342993|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||Wilcoxon rank-sum test|||Day 1||||0.157
71911104|NCT01602549|143342993|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Wilcoxon rank-sum test|||Day 8||||0.186
71911105|NCT01602549|143342995|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.239|||||TWO_SIDED|95.0|-16.015|7.537|||||Day 1: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1||7.537|-16.015|
71682582|NCT01149421|142883401|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.5|||<|0.001|TWO_SIDED|97.3|-0.68|1.68||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.68|-0.68|<0.001
71911106|NCT01602549|143342995|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.327|||||TWO_SIDED|95.0|-17.567|6.914|||||Day 8: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8||6.914|-17.567|
71911107|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.16||||||95.0|-3.9|-0.41|||||Day 1; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 1||-0.41|-3.90|
71911108|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.63|||||TWO_SIDED|95.0|-5.41|-1.85|||||Day 8; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 8||-1.85|-5.41|
71911109|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.29|||||TWO_SIDED|95.0|-4.65|0.07|||||Day 1; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 1||0.07|-4.65|
71911110|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.46|||||TWO_SIDED|95.0|-4.85|-0.07|||||Day 8; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 8||-0.07|-4.85|
71866059|NCT02311673|143247714|OTHER||LS Mean Difference|1.9||||0.809|TWO_SIDED|95.0|-2.6|6.4||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|Statistical analysis is provided for percent change from baseline at Day 56.||6.4|-2.6|0.809
71866060|NCT02311673|143247715|OTHER||LS Mean Difference|0.5||||0.633|TWO_SIDED|95.0|-2.6|3.6||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.6|-2.6|0.633
71866061|NCT02311673|143247715|OTHER||LS Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-2.1|2.3||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.3|-2.1|0.528
71866062|NCT02311673|143247715|OTHER||LS Mean Difference|0.5||||0.648|TWO_SIDED|95.0|-2.0|2.9||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.9|-2.0|0.648
71866063|NCT02311673|143247717|OTHER||LS Mean Difference|0.7||||0.712|TWO_SIDED|95.0|-1.8|3.1||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||3.1|-1.8|0.712
71866064|NCT02311673|143247717|OTHER||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-1.9|1.5||One sided p-value.|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||1.5|-1.9|0.414
71911111|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.38|||||TWO_SIDED|95.0|-10.28|-0.49|||||Day 8; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III -GSK962040 50 mg Vs Placebo Day 8||-0.49|-10.28|
71911112|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.56|||||TWO_SIDED|95.0|-1.65|0.54|||||Day 1; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 1||0.54|-1.65|
71911113|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.9|||||TWO_SIDED|95.0|-2.02|0.22|||||Day 8; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 8||0.22|-2.02|
71911114|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.69|||||TWO_SIDED|95.0|-13.77|0.39|||||Day 1; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 1||0.39|-13.77|
71911115|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-12.5|||||TWO_SIDED|95.0|-19.67|-5.29|||||Day 8; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 8||-5.29|-19.67|
71911116|NCT01602549|143342996|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.7|||||TWO_SIDED|95.0|-6.53|3.13|||||Day 1; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III- GSK962040 50 mg Vs Placebo Day 1||3.13|-6.53|
71922226|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-6.2|STANDARD_ERROR_OF_MEAN|3.36|||TWO_SIDED|95.0|-13.16|0.76|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||0.76|-13.16|
71922227|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.61|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-7.87|4.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||4.65|-7.87|
71922228|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-0.63|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-6.85|5.59|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||5.59|-6.85|
71922229|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-6.91|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|95.0|-12.74|-1.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||-1.08|-12.74|
71922230|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.74|||TWO_SIDED|95.0|-9.73|1.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||1.66|-9.73|
71922231|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-8.25|STANDARD_ERROR_OF_MEAN|2.57|||TWO_SIDED|95.0|-13.59|-2.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-2.91|-13.59|
71922232|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-5.56|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-10.76|-0.35|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||-0.35|-10.76|
71866065|NCT02311673|143247717|OTHER||LS Mean Difference|0.6||||0.732|TWO_SIDED|95.0|-1.3|2.5||One sided p-value|Longitudinal mixed analysis of variance||A longitudinal mixed analysis of variance model with fixed effects for treatment, time, treatment-by-time interaction, treatment-by-baseline weight interaction, baseline weight as covariate and participant as random effect was used.|||2.5|-1.3|0.732
71866066|NCT00414908|143247729|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||<0.0001
71866067|NCT00414908|143247730|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.||||0.0002
71911117|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.14|||||TWO_SIDED|95.0|-9.07|2.78|||||Day 1; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 1||2.78|-9.07|
71911118|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.18|||||TWO_SIDED|95.0|-9.11|2.75|||||Day 1; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||2.75|-9.11|
71911119|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.66|||||TWO_SIDED|95.0|-9.59|2.27|||||Day 1; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1:||2.27|-9.59|
71911120|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.15|||||TWO_SIDED|95.0|-10.07|1.76|||||Day 1; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||1.76|-10.07|
71911121|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.8|||||TWO_SIDED|95.0|-12.79|-0.81|||||Day 8; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 8||-0.81|-12.79|
71911122|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.97|||||TWO_SIDED|95.0|-9.96|2.03|||||Day 8; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||2.03|-9.96|
71911123|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-5.29|||||TWO_SIDED|95.0|-11.29|0.71|||||Day 8; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||0.71|-11.29|
71911124|NCT01602549|143342997|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-8.9|||||TWO_SIDED|95.0|-14.88|-2.91|||||Day 8; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment\*visit\*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||-2.91|-14.88|
71911125|NCT01602549|143342998|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.31|||||TWO_SIDED|95.0|-3.71|-0.9|||||OFF: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|OFF: Treatment Period||-0.90|-3.71|
71911126|NCT01602549|143342998|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.88|||||TWO_SIDED|95.0|0.28|3.48|||||ON: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|ON: Treatment Period||3.48|0.28|
71911127|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.83|||||TWO_SIDED|95.0|-21.79|16.13|||||Day 1, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: Day GSK962040 50 mg Vs Placebo Day 1||16.13|-21.79|
71911128|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.58|||||TWO_SIDED|95.0|-18.39|19.56|||||Day 1, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 1||19.56|-18.39|
71911129|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|1.84|||||TWO_SIDED|95.0|-17.18|20.86|||||Day 1, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Day 1, 30 min PD||20.86|-17.18|
71911130|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.28|||||TWO_SIDED|95.0|-18.72|19.28|||||Day 1, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 1||19.28|-18.72|
71682583|NCT01149421|142883401|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.16|||<|0.001|TWO_SIDED|97.3|-1.0|1.31||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||1.31|-1.00|<0.001
71866068|NCT00414908|143247731|SUPERIORITY_OR_OTHER||LS Means difference|-112.45|||<|0.0001||95.0|-147.04|-77.87|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool fat at baseline as a covariate."||-77.87|-147.04|<0.0001
71866069|NCT00414908|143247732|SUPERIORITY_OR_OTHER||LS Means difference|-11.68|||<|0.0001||95.0|-17.3|-6.06|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo. For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool nitrogen at baseline as a covariate."||-6.06|-17.30|<0.0001
71866070|NCT00414908|143247733|SUPERIORITY_OR_OTHER||LS Means difference|-0.76||||0.005||95.0|-1.27|-0.24|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal). The hypothesis was to show superior efficacy of pancrelipase capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool frequency at baseline as a covariate."||-0.24|-1.27|0.005
71866071|NCT00414908|143247737|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Paired t-test|Mean difference based on all subjects combined using the paired t-test between baseline and visit 8 or early termination||||||<0.001
71866072|NCT00921687|143247767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.04|TWO_SIDED|95.0|1.01|2.3|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||2.30|1.01|0.04
71866073|NCT00921687|143247768|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.44||95.0|0.84|1.49|||Generalized Estimating Equation||Intervention clinic (vs control clinic)|||1.49|0.84|0.44
71866074|NCT00316602|143247769|NON_INFERIORITY|The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.|Difference in seroconversion rates (%)|-1.2|||||ONE_SIDED|97.5|-4.3||||||||||-4.3|
71866075|NCT00626990|143247781|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.76|TWO_SIDED|99.1|0.73|1.28|||Regression, Cox|||||1.28|0.73|0.76
71866076|NCT00626990|143247781|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.52|0.79|||Regression, Cox|||||0.79|0.52|<0.0001
71866077|NCT00626990|143247782|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.11|TWO_SIDED|95.0|0.72|1.03|||Regression, Cox|||||1.03|0.72|0.11
71866078|NCT00626990|143247782|SUPERIORITY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.49|0.7|||Regression, Cox|||||0.70|0.49|<0.0001
71911131|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.38|||||TWO_SIDED|95.0|-22.35|15.58|||||Day 1, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 1||15.58|-22.35|
71866079|NCT01008410|143247828|SUPERIORITY|||||||0.0324||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).||||0.0324
71866080|NCT03248882|143247840|SUPERIORITY||Mean Difference (Net)|-10.7|||||TWO_SIDED|80.0|-19.4|-1.1||||||||-1.1|-19.4|
71866081|NCT03248882|143247840|SUPERIORITY||Mean Difference (Net)|-46.0|||||TWO_SIDED|80.0|-51.3|-40.1||||||||-40.1|-51.3|
71866082|NCT03248882|143247840|SUPERIORITY||Mean Difference (Net)|-52.4|||||TWO_SIDED|80.0|-57.2|-47.1||||||||-47.1|-57.2|
71866083|NCT03248882|143247840|SUPERIORITY||Mean Difference (Net)|-62.1|||||TWO_SIDED|80.0|-66.0|-57.8||||||||-57.8|-66.0|
71866084|NCT03248882|143247841|SUPERIORITY||Mean Difference (Net)|-4.4|||||TWO_SIDED|80.0|-14.0|6.3||||||||6.3|-14.0|
71866085|NCT03248882|143247841|SUPERIORITY||Mean Difference (Net)|-21.0|||||TWO_SIDED|80.0|-29.0|-12.2||||||||-12.2|-29.0|
71866086|NCT03248882|143247841|SUPERIORITY||Mean Difference (Net)|-25.0|||||TWO_SIDED|80.0|-32.8|-16.1||||||||-16.1|-32.8|
71866087|NCT03248882|143247841|SUPERIORITY||Mean Difference (Net)|-41.8|||||TWO_SIDED|80.0|-47.9|-35.0||||||||-35.0|-47.9|
71866088|NCT01167452|143247883|SUPERIORITY_OR_OTHER||Slope|-0.74|STANDARD_DEVIATION|0.19||0.0004|TWO_SIDED||||||Regression, Linear|Multivariate adaptive regression spline (MARS) analysis||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed weight for each participant.||||0.0004
71866089|NCT01167452|143247883|SUPERIORITY_OR_OTHER||Slope|-0.56|STANDARD_DEVIATION|0.2|<|0.0001|TWO_SIDED||||||Regression, Linear|Multiple Adaptive Regression Spline (MARS)||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed body mass index for each participant.||||<0.0001
71866090|NCT01417104|143247945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.16|||<|0.031|TWO_SIDED|95.0|0.85|9.47|||t-test, 2 sided|||||9.47|0.85|<0.031
71866091|NCT01417104|143247946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.041|TWO_SIDED|95.0|0.44|4.36|||t-test, 2 sided|||||4.36|0.44|0.041
71866092|NCT03101462|143247948|OTHER|ANOVA||||||0.89|||||||t-test, 2 sided|||A/H1N1 Day 0||||0.89
71866093|NCT03101462|143247948|OTHER|||||||0.00082||||||This is the calculated p-value.|t-test, 2 sided|||A/H1N1 Day 7||||0.00082
71866094|NCT03101462|143247948|OTHER|||||||7.6e-05||||||This is the calculated p-value|t-test, 2 sided|||A/H1N1 Day 45||||0.000076
71866095|NCT03101462|143247948|OTHER|||||||0.63|||||||t-test, 2 sided|||A/H3N2 Day 0||||0.63
71922233|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-7.07|STANDARD_ERROR_OF_MEAN|3.91|||TWO_SIDED|95.0|-15.2|1.05|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.05|-15.20|
71866096|NCT03101462|143247948|OTHER|||||||0.0186||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 7||||0.0186
71682584|NCT01149421|142883401|SUPERIORITY_OR_OTHER|||||||0.929||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.929
71866097|NCT03101462|143247948|OTHER|||||||0.0052||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 45||||0.0052
71866098|NCT03101462|143247948|OTHER|||||||0.25|||||||t-test, 2 sided|||Influenza B Day 0||||0.25
71866099|NCT03101462|143247948|OTHER|||||||0.061|||||||t-test, 2 sided|||Influenza B Day 7||||0.061
71866100|NCT03101462|143247948|OTHER|||||||0.0025|||||||t-test, 2 sided|||Influenza B Day 45||||0.0025
71866101|NCT03101462|143247949|OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.24
71866102|NCT03101462|143247949|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.76
71866103|NCT03101462|143247949|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.06
71866104|NCT03101462|143247949|OTHER|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.56
71866105|NCT03101462|143247949|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.04
71682585|NCT01149421|142883401|SUPERIORITY_OR_OTHER|||||||0.776||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.776
71866106|NCT03101462|143247949|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.16
71866107|NCT03101462|143247949|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7||||0.02
71866108|NCT03101462|143247949|OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45||||0.94
71866109|NCT03101462|143247949|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7||||0.002
71866110|NCT03101462|143247949|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45||||0.16
71866111|NCT03101462|143247949|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7||||0.02
71866112|NCT03101462|143247949|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45||||0.98
71866113|NCT03101462|143247950|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.04
71866114|NCT03101462|143247950|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.02
71866115|NCT03101462|143247950|OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.95
71866116|NCT03101462|143247950|OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.17
71866117|NCT03101462|143247950|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.06
71866118|NCT03101462|143247950|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.14
71866119|NCT03101462|143247950|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.02
71866120|NCT03101462|143247950|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.09
71866121|NCT03101462|143247950|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.01
71866122|NCT03101462|143247950|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.08
71866123|NCT03101462|143247950|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.16
71866124|NCT03101462|143247950|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.76
71866125|NCT03101462|143247950|OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.84
71866126|NCT03101462|143247950|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.04
71866127|NCT03101462|143247950|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.07
71866128|NCT03101462|143247950|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.27
71866129|NCT03101462|143247950|OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.11
71866130|NCT03101462|143247950|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.46
71866131|NCT03101462|143247950|OTHER|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7||||0.006
71866132|NCT03101462|143247950|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45||||0.41
71866133|NCT03101462|143247951|OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.72
71866134|NCT03101462|143247951|OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and 45||||0.06
71866135|NCT03101462|143247951|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.75
71866136|NCT03101462|143247951|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45||||0.05
71866137|NCT03101462|143247951|OTHER|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and Day 45||||0.0004
71866138|NCT03101462|143247951|OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45||||0.02
71866139|NCT03101462|143247952|OTHER|||||||0.02|||||||Fisher Exact|||Fold increase IgA anti-H1N1 HA, Day 7||||0.02
71866140|NCT03101462|143247952|OTHER|||||||0.67|||||||Fisher Exact|||Fold increase IgA anti-H3N2, Day 7||||0.67
71866141|NCT03101462|143247952|OTHER|||||||0.3|||||||Fisher Exact|||Fold increase IgA anti-influenza B HA, Day 7||||0.30
71866142|NCT01696955|143247956|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71866143|NCT01696955|143247959|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
71866144|NCT01696955|143247960|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
71866145|NCT01696955|143247961|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
71682586|NCT01149421|142883402|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|2.84||||0.556|TWO_SIDED|97.3|1.52|4.16||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.16|1.52|0.556
71682587|NCT01149421|142883402|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.62||||0.018|TWO_SIDED|97.3|0.32|2.92||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.92|0.32|0.018
71682588|NCT01149421|142883402|SUPERIORITY_OR_OTHER|||||||1||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||1.00
71682589|NCT01149421|142883402|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|3.5||||0.904|TWO_SIDED|97.3|2.1|4.91||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||4.91|2.10|0.904
71682590|NCT01149421|142883402|NON_INFERIORITY_OR_EQUIVALENCE|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.26||||0.005|TWO_SIDED|97.3|-0.13|2.64||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||2.64|-0.13|0.005
71682591|NCT01149421|142883402|SUPERIORITY_OR_OTHER|||||||0.996||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis|||||||0.996
71682592|NCT01149421|142883403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05|||<|0.001|TWO_SIDED|95.0|-4.0|-2.09||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-2.09|-4.00|<0.001
71682593|NCT01149421|142883403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.001|TWO_SIDED|95.0|-2.51|-0.64||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||-0.64|-2.51|0.001
71682594|NCT01149421|142883403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.1|-2.09||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-2.09|-4.10|<0.001
71682595|NCT01149421|142883403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|||<|0.001|TWO_SIDED|95.0|-2.98|-1.0||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-1.00|-2.98|<0.001
71682596|NCT01149421|142883404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.218|TWO_SIDED|95.0|-1.84|0.42||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||0.42|-1.84|0.218
71682597|NCT01149421|142883404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.931|TWO_SIDED|95.0|-1.16|1.06||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||1.06|-1.16|0.931
71682598|NCT01149421|142883404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.315|TWO_SIDED|95.0|-1.72|0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.55|-1.72|0.315
71866146|NCT03192475|143247965|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71866147|NCT03192475|143247966|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
71866148|NCT03192475|143247967|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71866149|NCT03192475|143247968|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||||||0.11
71866150|NCT03192475|143247969|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71866151|NCT03192475|143247970|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|||||||0.53
71866152|NCT03192475|143247971|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71866153|NCT03192475|143247972|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||||||0.60
71866154|NCT03192475|143247973|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|||||||0.15
71866155|NCT03192475|143247974|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
71866156|NCT03192475|143247975|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||||||0.96
71866157|NCT03192475|143247976|SUPERIORITY|||||||0.0009|||||||Mantel Haenszel|||||||0.0009
71866158|NCT03192475|143247977|SUPERIORITY|||||||0.18|||||||Mixed Models Analysis|||||||0.18
71866159|NCT03192475|143247978|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||||||0.34
71911132|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-4.18|||||TWO_SIDED|95.0|-23.13|14.76|||||Day 1, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1||14.76|-23.13|
71911133|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-6.39|||||TWO_SIDED|95.0|-25.36|12.58|||||Day 1, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1||12.58|-25.36|
71866160|NCT03192475|143247979|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
71866161|NCT00573859|143247990|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||A 2 (ADHD medication versus Placebo) repeated measure ANOVA||||<0.05
71866162|NCT00573859|143247991|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Four-way repeated measure ANOVA||||<0.05
71866163|NCT00573859|143247992|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||Friedman's two analysis of ranks|||Friedman's two-way analysis of variance by ranks.||||<0.05
71866164|NCT05319912|143247993|OTHER||Geometric Mean Ratio (%)|75.81|||||TWO_SIDED|90.0|52.23|110.02||||||Analysis was performed using analysis of variance (ANOVA).||110.02|52.23|
71866165|NCT05319912|143247993|OTHER||Geometric Mean Ratio (%)|25.2|||||TWO_SIDED|90.0|17.21|36.89||||||Analysis was performed using ANOVA.||36.89|17.21|
71866166|NCT05319912|143247994|OTHER||Geometric Mean Ratio (%)|82.65|||||TWO_SIDED|90.0|63.91|106.9||||||Analysis was performed using ANOVA.||106.90|63.91|
71866167|NCT05319912|143247994|OTHER||Geometric Mean Ratio (%)|40.49|||||TWO_SIDED|90.0|31.12|52.68||||||Analysis was performed using ANOVA.||52.68|31.12|
71866168|NCT01204710|143248020|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.29||||0.2201|TWO_SIDED|95.0|0.87|1.9||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as IMC-3G3 + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.90|0.87|0.2201
71866169|NCT01204710|143248021|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.7291|TWO_SIDED|95.0|0.72|1.61||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as Olaratumab + Mitoxantrone / Mitoxantrone and estimated from Cox model.|||1.61|0.72|0.7291
71866170|NCT01204710|143248022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3465|TWO_SIDED||||||Fisher Exact|||||||0.3465
71866171|NCT01204710|143248023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6571|TWO_SIDED||||||Fisher Exact|||||||0.6571
71866172|NCT01204710|143248024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Fisher Exact|||||||0.4986
71866173|NCT01276379|143248032|SUPERIORITY||Hazard Ratio (HR)|2.01||||0.004|TWO_SIDED|95.0|1.23|3.29|||Log Rank|||||3.29|1.23|0.004
71866174|NCT01276379|143248033|SUPERIORITY||Hazard Ratio (HR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.33|3.96|||Log Rank|||||3.96|1.33|<0.0001
71866175|NCT00864253|143248038|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.792||||0.044|TWO_SIDED|95.1|0.631|0.992||An interim safety review was performed by DMC. An alpha spending function was utilized to preserve the overall Type 1 error at 0.050. The spending function allocated alpha of 0.001 and 0.049 to the interim and final analyses of PFS, respectively.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||Two hundred fifty-seven (257) patients were to be randomized to each treatment group for a total of 514 patients. This sample size was chosen to provide at least 80% power for the final analysis (with a two-sided type I error of 0.049) to reject the null hypothesis that the ABI 007/dacarbazine hazard ratio (HR) for PFS is equal to 1.0. This sample size calculation was based on estimates of HR = 0.750. Proportional hazards were assumed.||0.992|0.631|0.044
71866176|NCT00864253|143248039|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.831||||0.094|TWO_SIDED|99.9|0.578|1.196||At the time of the final PFS analysis, an interim analysis of survival was reported. The spending function allocated an alpha of 0.001 and 0.049 for the interim and final analysis, respectively, to preserve the overall Type I error at 0.050.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||For the participant survival, at the time at least 417 events are recorded, this sample size provides at least 80% power with a two-sided Type 1 error of 0.049 to reject the null hypothesis that the ABI-007/dacarbazine hazard ratio is equal to 1.0. This was based on a HR = 0.760. Proportional hazards were assumed.||1.196|0.578|0.094
71866177|NCT00864253|143248040|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.845||||0.086|TWO_SIDED|95.0|0.696|1.025|||Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||||1.025|0.696|0.086
71866178|NCT00864253|143248041|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.305||||0.239|TWO_SIDED|95.0|0.837|2.035|||Chi-squared|||||2.035|0.837|0.239
71866179|NCT00864253|143248042|SUPERIORITY_OR_OTHER_LEGACY||Response Rate Ratio|1.442||||0.004|TWO_SIDED|95.0|1.123|1.582|||Chi-squared|||||1.582|1.123|0.004
71866180|NCT00864253|143248043|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.201||||0.057|TWO_SIDED|95.0|0.959|5.053|||Log Rank|||||5.053|0.959|0.057
71866181|NCT02001064|143248157|SUPERIORITY||Odds Ratio (OR)|2.3||||0.32|TWO_SIDED||||||t-test, 1 sided|||||||0.32
71866182|NCT02001064|143248158|SUPERIORITY|||||||0.073||||||Cohen's d (ranks) = -.049|Wilcoxon (Mann-Whitney)|||||||0.073
71866183|NCT02001064|143248159|SUPERIORITY|||||||0.24||||||Cohen's d=0.31|Wilcoxon (Mann-Whitney)|||||||0.24
71866184|NCT01743989|143248188|SUPERIORITY|||||||0.383|||||||Chi-squared|||||||0.383
71866185|NCT00515723|143248211|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) as the independent variable, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.002
71866186|NCT00515723|143248211|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) and treatment group as independent variables, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.002
71866187|NCT00515723|143248212|SUPERIORITY|||||||0.05||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) as the independent variable, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).||||0.05
71866188|NCT00515723|143248212|SUPERIORITY|||||||0.22||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) and treatment group as the independent variables, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).||||0.22
71866189|NCT02314780|143248241|OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
71866190|NCT02314780|143248242|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
71866191|NCT02314780|143248243|OTHER||||||=|0.002|||||||ANOVA|||||||=0.002
71866192|NCT02314780|143248244|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71866193|NCT02314780|143248245|OTHER||||||=|0.138|||||||ANOVA|||||||=0.138
71866194|NCT02314780|143248246|OTHER||||||=|0.696|||||||ANOVA|||||||=0.696
71866195|NCT00215137|143248257|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.||||0.0002
71866196|NCT00215137|143248257|SUPERIORITY_OR_OTHER|||||||0.0417|TWO_SIDED|95.0|||||Wilcoxon Rank Sum Test|||A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.||||.0417
71866197|NCT01006252|143248264|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.121
71866198|NCT01006252|143248265|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.048||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|Analysis adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group||||||0.048
71866199|NCT01006252|143248266|SUPERIORITY_OR_OTHER|||||||0.396||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates||||||0.396
71866200|NCT01006252|143248268|SUPERIORITY_OR_OTHER|||||||0.483||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates.||||||0.483
71866201|NCT01006252|143248269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.505||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|||||||0.505
71866202|NCT01006252|143248270|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
71866203|NCT01006252|143248270|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
71866204|NCT01006252|143248272|SUPERIORITY_OR_OTHER|||||||0.902||95.0||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.902
71866205|NCT01006252|143248272|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||P-value given for Overall Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.970
71866206|NCT01006252|143248273|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
71866207|NCT01006252|143248273|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
71866208|NCT01006252|143248275|SUPERIORITY_OR_OTHER|||||||0.547||95.0||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.547
71866209|NCT01006252|143248275|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.||||||0.414
71866210|NCT02683772|143248300|NON_INFERIORITY|The method proposed for this analysis was a one-sided paired t-test using a significance level of 0.05 and a non-inferiority margin of 2 events/hour|Mean Difference (Final Values)|-4.45|STANDARD_DEVIATION|17.23||0.0134|TWO_SIDED||||||t-test, 1 sided|||||||0.0134
71866211|NCT00297427|143248321|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71866212|NCT00297427|143248322|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
71866213|NCT00297427|143248323|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.16
71866214|NCT00297427|143248324|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.18
71866215|NCT00297427|143248326|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71866216|NCT00297427|143248327|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.38
71866217|NCT00297427|143248328|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
71866218|NCT00297427|143248330|SUPERIORITY_OR_OTHER|||||||0.04|||||||Repeated measures using GEE|||||||0.04
71866219|NCT00297427|143248331|SUPERIORITY_OR_OTHER|||||||0.01|||||||Repeated measures using GEE|||||||0.01
71866220|NCT00297427|143248332|SUPERIORITY_OR_OTHER|||||||0.41|||||||Repeated measures using GEE|||||||0.41
71866221|NCT00297427|143248333|SUPERIORITY_OR_OTHER|||||||0.04||||||Bivariate (unadjusted) analysis|t-test, 2 sided|||||||0.04
71866222|NCT00297427|143248333|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.208||||0.014|TWO_SIDED|95.0|1.039|1.405|||Regression, Logistic||These are the adjusted results of a multivariate logistic regression.|||1.405|1.039|0.014
71866223|NCT00297427|143248334|SUPERIORITY_OR_OTHER|||||||0.023||||||This is the result from the bivariate (unadjusted) analysis.|t-test, 2 sided|||||||0.023
71866224|NCT00297427|143248334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.936||||0.03|TWO_SIDED|95.0|0.881|0.994|||Regression, Logistic||These are the adjusted results from a multivariate logistic regression analysis.|||0.994|0.881|0.030
71866225|NCT00297427|143248335|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||||||0.64
71866226|NCT00297427|143248336|SUPERIORITY_OR_OTHER|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71866227|NCT00297427|143248338|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<.001
71866228|NCT00297427|143248339|SUPERIORITY_OR_OTHER|||||||0.48|||||||t-test, 2 sided|||||||0.48
71866229|NCT00297427|143248340|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||||||0.86
71866230|NCT02787044|143248347|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.21|TWO_SIDED|95.0|0.97|1.17|||Regression, Cox|||Note, each participant can be included in the primary analysis up to 3 times (participating seasons).||1.17|0.97|0.21
71866231|NCT02787044|143248348|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.44|TWO_SIDED|95.0|0.94|1.15|||Regression, Cox|||||1.15|0.94|0.44
71866232|NCT02787044|143248349|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.16|TWO_SIDED|95.0|0.97|1.2|||Regression, Cox|||Each participant can be analyzed up to three times (seasons)||1.2|.97|0.16
71866233|NCT02787044|143248350|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.26|TWO_SIDED|95.0|0.96|1.15|||Regression, Cox|||||1.15|.96|0.26
71866234|NCT02787044|143248351|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.96|TWO_SIDED|95.0|0.84|1.21|||Regression, Cox|||||1.21|0.84|0.96
71866235|NCT02071290|143248452|SUPERIORITY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
71866236|NCT02071290|143248453|SUPERIORITY|||||||0.287|||||||Mixed Models Analysis|||||||0.287
71866237|NCT02071290|143248454|SUPERIORITY|||||||0.597|||||||Mixed Models Analysis|||||||0.597
71866238|NCT02071290|143248455|SUPERIORITY|||||||0.307|||||||Mixed Models Analysis|||||||0.307
71866239|NCT02071290|143248456|SUPERIORITY|||||||0.646|||||||Mixed Models Analysis|||||||0.646
71866240|NCT02071290|143248457|SUPERIORITY|||||||0.757|||||||Mixed Models Analysis|||||||0.757
71866241|NCT02071290|143248458|SUPERIORITY|||||||0.075|||||||Mixed Models Analysis|||||||0.075
71866242|NCT02071290|143248459|SUPERIORITY|||||||0.967|||||||Mixed Models Analysis|||||||0.967
71866243|NCT02071290|143248460|SUPERIORITY|||||||0.637|||||||Mixed Models Analysis|||||||0.637
71866244|NCT02071290|143248461|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.664
71866245|NCT02071290|143248462|SUPERIORITY|||||||0.661|||||||Mixed Models Analysis|||||||0.661
71866246|NCT02071290|143248463|SUPERIORITY|||||||0.916|||||||Mixed Models Analysis|||||||0.916
71866247|NCT02071290|143248464|SUPERIORITY|||||||0.437|||||||Mixed Models Analysis|||||||0.437
71866248|NCT02071290|143248465|SUPERIORITY|||||||0.353|||||||Mixed Models Analysis|||||||0.353
71911134|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.77|||||TWO_SIDED|95.0|-18.2|19.75|||||Day 1, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1||19.75|-18.20|
71911135|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|0.51|||||TWO_SIDED|95.0|-18.51|19.52|||||Day 8, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: GSK962040 50 mg Vs Placebo Day 8||19.52|-18.51|
71911136|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.32|||||TWO_SIDED|95.0|-15.7|22.33|||||Day 8, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 8||22.33|-15.70|
71911137|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-2.94|||||TWO_SIDED|95.0|-21.97|16.08|||||Day 8, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|30 min PD: GSK962040 50 mg Vs Placebo Day 8||16.08|-21.97|
71911138|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-3.12|||||TWO_SIDED|95.0|-22.13|15.88|||||Day 8, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 8||15.88|-22.13|
71911139|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-1.38|||||TWO_SIDED|95.0|-20.4|17.63|||||Day 8, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 8||17.63|-20.40|
71911140|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|-0.71|||||TWO_SIDED|95.0|-19.7|18.28|||||Day 8, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8||18.28|-19.70|
71911141|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|3.02|||||TWO_SIDED|95.0|-15.98|22.02|||||Day 8, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8||22.02|-15.98|
71911142|NCT01602549|143342999|SUPERIORITY_OR_OTHER||Difference in AMs of change from BL|4.08|||||TWO_SIDED|95.0|-14.91|23.07|||||Day 8, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment\*visit\*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8||23.07|-14.91|
71911143|NCT00771173|143343021|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.||||.745
71911144|NCT00719862|143343022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05|STANDARD_DEVIATION|0.3782||0.005||95.0|-1.8|-0.31|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.31|-1.80|0.005
71866249|NCT02071290|143248466|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||||||0.99
71866250|NCT02071290|143248467|SUPERIORITY|||||||0.085|||||||Mixed Models Analysis|||||||0.085
71866251|NCT02071290|143248468|SUPERIORITY|||||||0.371|||||||Mixed Models Analysis|||||||0.371
71911145|NCT00719862|143343023|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.2987|STANDARD_DEVIATION|0.1881||0.112||95.0|-0.67|0.07|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||0.07|-0.67|0.112
71866252|NCT02071290|143248469|SUPERIORITY|||||||0.106|||||||Mixed Models Analysis|||||||0.106
71866253|NCT02071290|143248470|SUPERIORITY|||||||0.829|||||||Mixed Models Analysis|||||||0.829
71866254|NCT02071290|143248471|SUPERIORITY|||||||0.323|||||||Wilcoxon (Mann-Whitney)|||||||0.323
71866255|NCT02071290|143248472|SUPERIORITY|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||||||0.287
71866256|NCT02071290|143248473|SUPERIORITY|||||||0.151|||||||Wilcoxon (Mann-Whitney)|||||||0.151
71866257|NCT02071290|143248474|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.510
71866258|NCT02071290|143248475|SUPERIORITY|||||||0.348|||||||Chi-squared|||||||0.348
71866259|NCT02071290|143248476|SUPERIORITY|||||||0.911|||||||Chi-squared|||||||0.911
71911146|NCT00719862|143343024|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8617|STANDARD_DEVIATION|0.3803||0.023||95.0|-1.61|-0.12|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.12|-1.61|0.023
71911147|NCT00719862|143343025|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7395|STANDARD_DEVIATION|0.3305||0.025||95.0|-1.39|-0.09|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||-0.09|-1.39|0.025
71911148|NCT00719862|143343026|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANOVA|||Change from baseline||||0.051
71911149|NCT00892957|143343043|SUPERIORITY_OR_OTHER||||||<|0.0001|ONE_SIDED|95.0|||||Likelihood ratio chi-square test|||||||<0.0001
71911150|NCT00892957|143343044|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.001
71911151|NCT00892957|143343045|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.012
71866260|NCT04488770|143248529|OTHER||Ratio of Geometric Mean|0.75|||||TWO_SIDED|90.0|0.61|0.93|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-24). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Unstructured covariance structure is used.|||0.93|0.61|
71866261|NCT04488770|143248530|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
71866262|NCT04488770|143248531|OTHER||Ratio of Geometric Mean|0.8|||||TWO_SIDED|90.0|0.65|0.98|||||Mixed Effect Model was used to assess Food Effect for log transformed parameter AUC(0-infinity). Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.98|0.65|
71866263|NCT04488770|143248532|OTHER||Ratio of Geometric Mean|0.59|||||TWO_SIDED|90.0|0.46|0.75|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||0.75|0.46|
71866264|NCT04488770|143248533|OTHER||Ratio of Geometric Mean|0.91|||||TWO_SIDED|90.0|0.74|1.11|||||Mixed Effect Model was used to assess Food Effect for the log transformed parameter C24h. Treatment in the fed/fasted state was fitted as Fixed Effect. Participant was fitted as Random Effect. Unstructured covariance structure was used.|||1.11|0.74|
71866265|NCT04488770|143248534|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|2.0|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tmax.|||2.000|0.000|
71866266|NCT04488770|143248535|OTHER||Median Difference (Net)|0.0|||||TWO_SIDED|90.0|0.0|0.25|||||Wilcoxon matched pair test was used to assess Food Effect for the parameter Tlag.|||0.250|0.000|
71866267|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|7.11|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71911152|NCT00892957|143343046|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.158
71911153|NCT00892957|143343048|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.380
71911154|NCT00892957|143343049|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED|95.0|||||Likelihood ratio chi-square test|||||||0.545
71922234|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-5.85|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-13.68|1.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||1.98|-13.68|
71922235|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|4.2|||TWO_SIDED|95.0|-10.14|7.33|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||7.33|-10.14|
71922236|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-5.16|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|-13.46|3.14|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||3.14|-13.46|
71922237|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-2.37|STANDARD_ERROR_OF_MEAN|3.74|||TWO_SIDED|95.0|-10.14|5.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||5.40|-10.14|
71922238|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-4.51|STANDARD_ERROR_OF_MEAN|3.72|||TWO_SIDED|95.0|-12.25|3.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||3.23|-12.25|
71922239|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-0.44|STANDARD_ERROR_OF_MEAN|3.44|||TWO_SIDED|95.0|-7.6|6.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||6.72|-7.60|
71922240|NCT03091920|143365004|OTHER|No statistical testing was performed.|Least squares mean difference|-1.98|STANDARD_ERROR_OF_MEAN|3.32|||TWO_SIDED|95.0|-8.88|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.92|-8.88|
71922241|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|3.19|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|-0.1|6.48|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.48|-0.10|
71922242|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|3.53|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.25|6.82|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.82|0.25|
71922243|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|3.36|STANDARD_ERROR_OF_MEAN|1.43|||TWO_SIDED|95.0|0.4|6.32|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 1||6.32|0.40|
71922244|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|4.59|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|95.0|0.95|8.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.23|0.95|
71922245|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|4.49|STANDARD_ERROR_OF_MEAN|1.75|||TWO_SIDED|95.0|0.86|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.12|0.86|
71911155|NCT01060098|143343116|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.003
71911156|NCT01060098|143343116|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.04
71866268|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|5.98|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866269|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|7.17||||0.0006|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0006
71866270|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|4.75|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866271|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|5.95||||0.0002|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0002
71866272|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 500 lux is reported."|Slope|6.92||||0.0285|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0285
71866273|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 500 lux is reported."|Slope|6.99|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71911157|NCT01060098|143343116|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12||||0.48
71911158|NCT00107172|143343117|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.01||||0.98|TWO_SIDED|95.0|0.51|1.98|||Log Rank|Competing risk P-value = 0.91.||The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.||1.98|0.51|0.98
71911159|NCT00107172|143343118|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.07||||0.75|TWO_SIDED|95.0|0.71|1.61|||Log Rank|||||1.61|0.71|0.75
71911160|NCT00107172|143343123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.||||0.37
71911161|NCT00107172|143343123|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.||||0.25
71911162|NCT00107172|143343124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.||||0.35
71911163|NCT00107172|143343124|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31|TWO_SIDED||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.||||0.31
71911164|NCT00107172|143343127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.03
71682599|NCT01149421|142883404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.465|TWO_SIDED|95.0|-1.54|0.7||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||0.70|-1.54|0.465
71911165|NCT00107172|143343127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.18
71682600|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||<|0.001|TWO_SIDED|95.0|-5.04|-1.61||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||-1.61|-5.04|<0.001
71682601|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.153|TWO_SIDED|95.0|-2.91|0.46||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.46|-2.91|0.153
71911166|NCT00107172|143343128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.||||0.38
71911167|NCT00107172|143343128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.||||0.16
71911168|NCT02061748|143343146|SUPERIORITY_OR_OTHER|||||||0.0111|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0111
71911169|NCT02061748|143343147|SUPERIORITY_OR_OTHER|||||||0.0861|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0861
71911170|NCT02061748|143343148|SUPERIORITY_OR_OTHER|||||||0.0011|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0011
71911171|NCT02061748|143343149|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0019
71911172|NCT02061748|143343150|SUPERIORITY_OR_OTHER|||||||0.0808|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0808
71911173|NCT02061748|143343151|SUPERIORITY_OR_OTHER|||||||0.3502|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3502
71911174|NCT02061748|143343152|SUPERIORITY_OR_OTHER|||||||0.0068|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0068
71911175|NCT02061748|143343153|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0271
71911176|NCT02061748|143343154|SUPERIORITY_OR_OTHER|||||||0.0749|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0749
71911177|NCT02061748|143343155|SUPERIORITY_OR_OTHER|||||||0.0072|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0072
71911178|NCT02061748|143343156|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0055
71911179|NCT02061748|143343157|SUPERIORITY_OR_OTHER|||||||0.0284|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0284
71911180|NCT02061748|143343158|SUPERIORITY_OR_OTHER|||||||0.907|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.907
71911181|NCT02061748|143343159|SUPERIORITY_OR_OTHER|||||||0.8208|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8208
71911182|NCT02061748|143343160|SUPERIORITY_OR_OTHER|||||||0.1534|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.1534
71911183|NCT02061748|143343161|SUPERIORITY_OR_OTHER|||||||0.3055|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.3055
71911184|NCT02061748|143343162|SUPERIORITY_OR_OTHER|||||||0.9573|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.9573
71911185|NCT02061748|143343163|SUPERIORITY_OR_OTHER|||||||0.8465|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8465
71911186|NCT02061748|143343164|SUPERIORITY_OR_OTHER|||||||0.0006|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0006
71911187|NCT02061748|143343165|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||<0.0001
71911188|NCT02061748|143343166|SUPERIORITY_OR_OTHER|||||||0.0185|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0185
71911189|NCT02061748|143343167|SUPERIORITY_OR_OTHER|||||||0.0138|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0138
71911190|NCT02061748|143343168|SUPERIORITY_OR_OTHER|||||||0.261|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.261
71911191|NCT02061748|143343169|SUPERIORITY_OR_OTHER|||||||0.4407|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.4407
71911192|NCT02061748|143343170|SUPERIORITY_OR_OTHER|||||||0.2665|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.2665
71911193|NCT02061748|143343171|SUPERIORITY_OR_OTHER|||||||0.8017|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.8017
71911194|NCT02061748|143343172|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||<0.0001
71911195|NCT02061748|143343173|SUPERIORITY_OR_OTHER|||||||0.2083|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2083
71911196|NCT02061748|143343174|SUPERIORITY_OR_OTHER|||||||0.0023|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0023
71911197|NCT02061748|143343175|SUPERIORITY_OR_OTHER|||||||0.5331|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.5331
71911198|NCT02061748|143343176|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0003
71911199|NCT02061748|143343177|SUPERIORITY_OR_OTHER|||||||0.2646|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.2646
71911200|NCT02061748|143343178|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.||||0.0004
71911201|NCT02061748|143343179|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.||||0.0004
71911202|NCT03706040|143343185|SUPERIORITY||Adjusted Difference|13.0||||0.084|TWO_SIDED|95.0|-1.7|27.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||27.7|-1.7|0.084
71911203|NCT03706040|143343185|SUPERIORITY||Adjusted Difference|10.0||||0.179|TWO_SIDED|95.0|-4.6|24.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.6|-4.6|0.179
71911204|NCT03706040|143343186|SUPERIORITY||Adjusted Difference|8.7||||0.129|TWO_SIDED|95.0|-2.5|20.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||20.0|-2.5|0.129
71911205|NCT03706040|143343186|SUPERIORITY||Adjusted Difference|0.0||||0.994|TWO_SIDED|95.0|-9.4|9.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||9.4|-9.4|0.994
71911206|NCT03706040|143343187|SUPERIORITY||Adjusted Difference|13.7||||0.001|TWO_SIDED|95.0|5.4|22.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||22.1|5.4|0.001
71911207|NCT03706040|143343187|SUPERIORITY||Adjusted Difference|15.3|||<|0.001|TWO_SIDED|95.0|6.6|24.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.0|6.6|<0.001
71911208|NCT03706040|143343188|SUPERIORITY||Least Squares (LS) Mean Difference|-10.32|STANDARD_ERROR_OF_MEAN|11.073||0.353|TWO_SIDED|95.0|-32.25|11.61|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||11.61|-32.25|0.353
71911209|NCT03706040|143343188|SUPERIORITY||LS Mean Difference|-16.86|STANDARD_ERROR_OF_MEAN|11.305||0.139|TWO_SIDED|95.0|-39.24|5.53|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||5.53|-39.24|0.139
71911210|NCT03706040|143343191|SUPERIORITY||Adjusted Difference|12.9||||0.171|TWO_SIDED|95.0|-5.6|31.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.4|-5.6|0.171
71682602|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.002|TWO_SIDED|95.0|-4.66|-1.09||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-1.09|-4.66|0.002
71866274|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|6.8|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866275|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|5.94||||0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0001
71866276|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|5.85||||0.012|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.012
71866277|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NYmass at 500 lux is reported."|Slope|-9.62||||0.0174|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0174
71866278|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 500 lux is reported."|Slope|-9.15||||0.013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.013
71882535|NCT02054897|143284140|SUPERIORITY|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Treatment difference|-1.43|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.15|||Mixed Models Analysis||Semaglutide 0.5 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.||-1.15|-1.71|< 0.0001
71882536|NCT00677014|143284151|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.66||95.0|||||ANOVA|As LVESV values were non normal by Q-Q analysis and Shapiro-Wilk test (p\<.05), a square root transform was used. model adjusted for baseline LVESV.||Gate keeping strategy utilized for Type 1 error control described in design paper - negative results observed for initial comparisons - (each at alpha = .05) between fixed and algorithm optimized AV delay and fixed and Echo optimzied AV. Results from both of these comparisons were non-significant.||||.66
71882537|NCT02374099|143284153|SUPERIORITY||Hazard Ratio (HR)|0.87|||=|0.599|TWO_SIDED|95.0|0.54|1.42|||Log Rank||||Hazard ratio and associated two-sided 95% confidence intervals (CI) were estimated by the Cox proportional hazard models.|1.42|0.54|= 0.599
71882538|NCT02374099|143284154|SUPERIORITY||Difference in Response Rates|6.3|||=|0.1479|TWO_SIDED|95.0|-2.47|15.06|||Fisher Exact||||The two-sided 95% confidence interval for the difference in ORR was estimated by the Wilson method.|15.06|-2.47|= 0.1479
71682603|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82||||0.042|TWO_SIDED|95.0|-3.57|-0.07||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.07|-3.57|0.042
71682604|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.221|TWO_SIDED|95.0|-3.23|0.75||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||0.75|-3.23|0.221
71866279|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-4.06|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866280|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|0.99||||0.0068|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0068
71866281|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|1.12||||0.0485|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0485
71866282|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 50 lux is reported."|Slope|2.08||||0.0031|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0031
71866283|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|1.18||||0.0036|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0036
71866284|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|1.05||||0.0089|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0089
71866285|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-4.04|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866286|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|1.62||||0.0239|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0239
71866287|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|0.93||||0.0435|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0435
71682605|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.884|TWO_SIDED|95.0|-2.1|1.81||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||1.81|-2.10|0.884
71866288|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Ctime at 500 lux is reported."|Slope|1.26||||0.0126|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0126
71866289|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 50 lux is reported."|Slope|-0.73||||0.0294|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0294
71866290|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D1m at 50 lux is reported."|Slope|0.96||||0.0204|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0204
71882539|NCT02374099|143284155|SUPERIORITY||Difference in Clinical Benefit Rate|0.7|||=|0.1732|TWO_SIDED|95.0|-17.76|19.04|||Fisher Exact||||The two-sided 95% confidence interval for the difference in clinical benefit rate was estimated by the Wilson method.|19.04|-17.76|= 0.1732
71882540|NCT02374099|143284156|SUPERIORITY||Hazard Ratio (HR)|0.59|||=|0.2725|TWO_SIDED|95.0|0.23|1.53|||Log Rank||||Hazard Ratio and associated two-sided 95% CI were estimated by the Cox proportional hazard model.|1.53|0.23|= 0.2725
71882541|NCT01033825|143284187|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-0.5|||>|0.05|TWO_SIDED|95.0|-13.9|13.0|||ANCOVA||Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)\<38|Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||13.0|-13.9|>0.05
71882542|NCT01033825|143284187|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-2.4||||0.025|TWO_SIDED|95.0|-15.1|10.2|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||10.2|-15.1|0.025
71882543|NCT01033825|143284187|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is \<Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL|Mean Difference (Final Values)|10.4|||>|0.05|TWO_SIDED|95.0|-4.7|25.5|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.||25.5|-4.7|>0.05
71882544|NCT00894556|143284235|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
71882545|NCT00894556|143284236|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.||||||<0.001
71882546|NCT04294901|143284340|SUPERIORITY||Odds Ratio (OR)|1.21||||0.008|TWO_SIDED|95.0|1.05|1.38|||Mixed Models Analysis|Binary mixed effect model with patients nested in providers nested in facilities||It is pre-specified in the Study Protocol and Statistical Analysis Plan to assess all medication groups combined within the Intervention and Control Arms/Groups.||1.38|1.05|0.008
71682606|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.19|TWO_SIDED|95.0|-4.31|-0.39||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||-0.39|-4.31|0.19
71682607|NCT01149421|142883405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.159|TWO_SIDED|95.0|-3.31|0.54||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||0.54|-3.31|0.159
71682608|NCT01149421|142883405|SUPERIORITY_OR_OTHER|||||||0.122||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.122
71882547|NCT02909985|143284355|SUPERIORITY||F|23.68|||<|0.0001|TWO_SIDED||||||ANOVA|(9, 129)||||||<0.0001
71882548|NCT02909985|143284355|SUPERIORITY||F|9.4394|||<|0.0001|TWO_SIDED||||||ANOVA|(11, 52)||||||<0.0001
71682609|NCT01149421|142883405|SUPERIORITY_OR_OTHER|||||||0.601||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis|||||||0.601
71682610|NCT01149421|142883405|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.012
71682611|NCT01149421|142883405|SUPERIORITY_OR_OTHER|||||||0.274||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis|||||||0.274
71682612|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.717|TWO_SIDED|95.0|-0.91|1.32||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.32|-0.91|0.717
71682613|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44||||0.427|TWO_SIDED|95.0|-0.65|1.54||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||1.54|-0.65|0.427
71882549|NCT03187769|143284388|SUPERIORITY||Least Squares Mean Difference|-1.87||||0.012|TWO_SIDED|95.0|-3.33|-0.41|||ANCOVA|||||-.41|-3.33|.012
71882550|NCT00879229|143284407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.0|STANDARD_ERROR_OF_MEAN|67.0||0.696|TWO_SIDED|95.0|-54.0|17.0||This is an exact Wilcoxon rank sum test p-value for testing equality of ambrisentan and placebo distributions.|Wilcoxon (Mann-Whitney)|||||17|-54|0.696
71882551|NCT01097746|143284418|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.33|TWO_SIDED|95.0|0.58|4.98|||t-test, 2 sided|||Participants for optimal ≤ 1 cm||4.98|0.58|0.33
71882552|NCT01097746|143284418|SUPERIORITY||Hazard Ratio (HR)|3.75||||0.04|TWO_SIDED|95.0|1.05|13.34|||t-test, 2 sided|||suboptimal \> 1 cm||13.34|1.05|0.04
71882553|NCT00631371|143284439|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.8|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and Memorial Sloan Kettering Cancer Center \[MSKCC\] risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.8
71882554|NCT00631371|143284440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.9|TWO_SIDED|95.0|1.0|1.4|||Log Rank|||P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.4|1.0|0.9
71882555|NCT00631371|143284441|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.8|1.3|||Cochran-Mantel-Haenszel|||P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.||1.3|0.8|1.0
71882556|NCT00631371|143284442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.6|TWO_SIDED|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy \[yes/no\] and MSKCC risk factors \[good/intermediate/poor\] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.||1.3|0.9|0.6
71882557|NCT00812214|143284456|SUPERIORITY|For the purpose of the power calculation, it was assumed that the difference in total sleep time between the treatment groups is 40 minutes, with a standard deviation of 60. The pilot nature of the study allowed the use of alpha = 0.05 and beta = 0.2, with two-sided comparison, generating a required sample size of 37 subjects per arm.||||||0.33|||||||t-test, 2 sided|two-tailed student's t-test for independent samples||The null hypothesis is that there is no difference in the 6 week average total sleep time||||0.33
71882558|NCT00812214|143284457|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between the eszopiclone and placebo groups in the number of awakenings/night at 6 weeks.||||0.03
71882559|NCT00812214|143284459|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in sleep quality averaged over 6 weeks of treatment.||||0.1
71882560|NCT00812214|143284459|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime alertness averaged over 6 weeks of treatment.||||0.29
71882561|NCT00812214|143284459|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime fatigue averaged over 6 weeks of treatment.||||0.05
71882562|NCT00812214|143284459|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between Eszopiclone and placebo groups in daytime functioning averaged over 6 weeks of treatment.||||0.76
71882563|NCT00812214|143284461|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in average days/week between eszopiclone and placebo groups at 6 weeks.||||0.89
71882564|NCT00812214|143284462|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache duration between eszopiclone and placebo groups at 6 weeks.||||0.98
71882565|NCT00812214|143284463|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||The null hypothesis is that there is no difference in headache intensity between eszopiclone and placebo groups at 6 weeks.||||0.82
71882566|NCT00129766|143284466|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.|Risk Ratio (RR)|0.74|||||TWO_SIDED|95.0|0.503|1.083|||t-test, 2 sided||Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.|ITT population||1.083|0.503|
71882567|NCT00129766|143284475|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.11||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Cochran-Mantel-Haenszel|||||||0.110
71866291|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for D2m at 50 lux is reported."|Slope|1.41||||0.0004|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0004
71866292|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-0.95||||0.0013|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0013
71866293|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-0.77||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
71866294|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-0.94|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866295|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 50 lux is reported."|Slope|0.81|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866296|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for NCdiff at 500 lux is reported."|Slope|-0.87||||0.0096|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0096
71866297|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Redness at 500 lux is reported."|Slope|0.36||||0.0003|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0003
71882568|NCT00129766|143284476|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.005||95.0||||No adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF||||||0.005
71882569|NCT00129766|143284477|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.476||95.0|||||Van Eleteren test|Test stratified by presence or absence of CLD of prematurity specified on the CRF||P-value is for overall incidence||||0.476
71882570|NCT00129766|143284478|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.493||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.493
71882571|NCT00129766|143284479|NON_INFERIORITY_OR_EQUIVALENCE|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.652||95.0||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test|||||||0.652
71882572|NCT04091087|143284489|SUPERIORITY||Least square (LS) mean difference|-14.36|STANDARD_ERROR_OF_MEAN|7.47||0.0299|TWO_SIDED|90.0|-26.87|-1.86||1-sided|ANOVA|||||-1.86|-26.87|0.0299
71682614|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.3|TWO_SIDED|95.0|-0.53|1.73||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.73|-0.53|0.300
71866298|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 50 lux is reported."|Slope|2.13||||0.0063|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0063
71882573|NCT04091087|143284490|SUPERIORITY||Difference in percentage of participants|3.33||||0.1546|TWO_SIDED|90.0|-2.06|8.72||1-sided|Normal approximation test|||||8.72|-2.06|0.1546
71682615|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.788|TWO_SIDED|95.0|-0.96|1.26||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.26|-0.96|0.788
71682616|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.08||||0.098|TWO_SIDED|95.0|-0.2|2.37||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.37|-0.20|0.098
71682617|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.203|TWO_SIDED|95.0|-0.44|2.08||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||2.08|-0.44|0.203
71866299|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 50 lux is reported."|Slope|2.3||||0.0018|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0018
71882574|NCT04091087|143284491|SUPERIORITY||Difference in percentage of participants|9.0||||0.0819|TWO_SIDED|90.0|-1.63|19.62||1-sided|Normal approximation test|||Week 1||19.62|-1.63|0.0819
71882575|NCT04091087|143284491|SUPERIORITY||Difference in percentage of participants|-0.47||||0.4789|TWO_SIDED|90.0|-15.2|14.25||1-sided|Normal approximation test|||Week 2||14.25|-15.20|0.4789
71882576|NCT04091087|143284491|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 3||13.03|-13.79|0.4815
71882577|NCT04091087|143284491|SUPERIORITY||Difference in percentage of participants|-0.38||||0.4815|TWO_SIDED|90.0|-13.79|13.03||1-sided|Normal approximation test|||Week 4||13.03|-13.79|0.4815
71882578|NCT04091087|143284491|SUPERIORITY||Difference in percentage of participants|8.9||||0.1197|TWO_SIDED|90.0|-3.55|21.35||1-sided|Normal approximation test|||Week 5||21.35|-3.55|0.1197
71882579|NCT04091087|143284491|SUPERIORITY||Difference in percentage of participants|18.18||||0.0034|TWO_SIDED|90.0|7.14|29.23||1-sided|Normal approximation test|||Week 6||29.23|7.14|0.0034
71882580|NCT04091087|143284492|SUPERIORITY||Difference in percentage of participants|5.13||||0.2896|TWO_SIDED|90.0|-10.09|20.34||1-sided|Normal approximation test|||||20.34|-10.09|0.2896
71882581|NCT04091087|143284493|SUPERIORITY||Difference in percentage of participants|7.77||||0.2648|TWO_SIDED|90.0|-12.55|28.08||1-sided|Normal approximation test|||Week 1||28.08|-12.55|0.2648
71882582|NCT04091087|143284493|SUPERIORITY||Difference in percentage of participants|17.05||||0.0809|TWO_SIDED|90.0|-2.99|37.08||1-sided|Normal approximation test|||Week 2||37.08|-2.99|0.0809
71882583|NCT04091087|143284493|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 3||21.99|-18.58|0.4450
71882584|NCT04091087|143284493|SUPERIORITY||Difference in percentage of participants|1.7||||0.445|TWO_SIDED|90.0|-18.58|21.99||1-sided|Normal approximation test|||Week 4||21.99|-18.58|0.4450
71882585|NCT04091087|143284493|SUPERIORITY||Difference in percentage of participants|20.45||||0.0385|TWO_SIDED|90.0|1.43|39.48||1-sided|Normal approximation test|||Week 5||39.48|1.43|0.0385
71882586|NCT04091087|143284493|SUPERIORITY||Difference in percentage of participants|29.64||||0.0045|TWO_SIDED|90.0|10.95|48.33||1 sided|Normal approximation test|||Week 6||48.33|10.95|0.0045
71882587|NCT04091087|143284494|SUPERIORITY||LS mean Difference|3.88|STANDARD_ERROR_OF_MEAN|13.49||0.3874|TWO_SIDED|90.0|-18.67|26.43||1-sided|Normal approximation test|||Week 1||26.43|-18.67|0.3874
71882588|NCT04091087|143284494|SUPERIORITY||LS mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|11.59||0.3506|TWO_SIDED|90.0|-23.85|14.91||1-sided|Normal approximation test|||Week 2||14.91|-23.85|0.3506
71882589|NCT04091087|143284494|SUPERIORITY||LS mean Difference|9.81|STANDARD_ERROR_OF_MEAN|14.23||0.2466|TWO_SIDED|90.0|-13.97|33.6||1-sided|Normal approximation test|||Week 3||33.60|-13.97|0.2466
71882590|NCT04091087|143284494|SUPERIORITY||LS mean Difference|34.74|STANDARD_ERROR_OF_MEAN|15.74||0.0157|TWO_SIDED|90.0|8.43|61.05||1-sided|Normal approximation test|||Week 4||61.05|8.43|0.0157
71882591|NCT04091087|143284494|SUPERIORITY||LS mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|14.55||0.4548|TWO_SIDED|90.0|-25.99|22.68||1-sided|Normal approximation test|||Week 5||22.68|-25.99|0.4548
71882592|NCT04091087|143284494|SUPERIORITY||LS mean Difference|-42.19|STANDARD_ERROR_OF_MEAN|11.99||0.0004|TWO_SIDED|90.0|-62.24|-22.15||1-sided|Normal approximation test|||Week 6||-22.15|-62.24|0.0004
71882593|NCT04091087|143284495|SUPERIORITY||LS mean difference|6.91|STANDARD_ERROR_OF_MEAN|9.65||0.2383|TWO_SIDED|90.0|-9.23|23.06||1 sided|ANOVA|||||23.06|-9.23|0.2383
71882594|NCT04091087|143284496|SUPERIORITY||LS mean Difference|-29.95|STANDARD_ERROR_OF_MEAN|21.01||0.0797|TWO_SIDED|90.0|-65.09|5.18||1-sided|Normal approximation test|||Week 1||5.18|-65.09|0.0797
71882595|NCT04091087|143284496|SUPERIORITY||LS mean Difference|-14.39|STANDARD_ERROR_OF_MEAN|18.79||0.2236|TWO_SIDED|90.0|-45.81|17.04||1-sided|Normal approximation test|||Week 2||17.04|-45.81|0.2236
71882596|NCT04091087|143284496|SUPERIORITY||LS mean Difference|-9.94|STANDARD_ERROR_OF_MEAN|15.05||0.2559|TWO_SIDED|90.0|-35.12|15.24||1-sided|Normal approximation test|||Week 3||15.24|-35.12|0.2559
71882597|NCT04091087|143284496|SUPERIORITY||LS mean Difference|-16.01|STANDARD_ERROR_OF_MEAN|22.44||0.2392|TWO_SIDED|90.0|-53.54|21.52||1-sided|Normal approximation test|||Week 4||21.52|-53.54|0.2392
71882598|NCT04091087|143284496|SUPERIORITY||LS mean Difference|-13.01|STANDARD_ERROR_OF_MEAN|19.65||0.2553|TWO_SIDED|90.0|-45.87|19.85||1-sided|Normal approximation test|||Week 5||19.85|-45.87|0.2553
71882599|NCT04091087|143284496|SUPERIORITY||LS mean Difference|-53.01|STANDARD_ERROR_OF_MEAN|30.05||0.0416|TWO_SIDED|90.0|-103.26|-2.75||1-sided|Normal approximation test|||Week 6||-2.75|-103.26|0.0416
71882600|NCT04152161|143284503|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
71882601|NCT04152161|143284503|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
71882602|NCT04152161|143284504|SUPERIORITY||Vaccine Efficacy|-0.009|||||TWO_SIDED|95.0|-0.395|0.27|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.270|-0.395|
71866300|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Pa at 50 lux is reported."|Slope|3.22||||0.0134|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0134
71866301|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dbase at 50 lux is reported."|Slope|-1.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71911211|NCT03706040|143343191|SUPERIORITY||Adjusted Difference|5.7||||0.552|TWO_SIDED|95.0|-13.1|24.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.5|-13.1|0.552
71911212|NCT03706040|143343193|SUPERIORITY||Adjusted Difference|11.6||||0.022|TWO_SIDED|95.0|1.7|21.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||21.6|1.7|0.022
71866302|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 50 lux is reported."|Slope|-2.48|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866303|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 50 lux is reported."|Slope|-1.264|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866304|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 50 lux is reported."|Slope|-1.47|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866305|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 50 lux is reported."|Slope|-1.64|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866306|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 50 lux is reported."|Slope|-1.63|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866307|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for PESC at 50 lux is reported."|Slope|1.43||||0.0313|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0313
71911213|NCT03706040|143343193|SUPERIORITY||Adjusted Difference|5.8||||0.192|TWO_SIDED|95.0|-2.9|14.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||14.4|-2.9|0.192
71911214|NCT03706040|143343196|SUPERIORITY||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|4.506||0.169|TWO_SIDED|95.0|-15.15|2.68|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.68|-15.15|0.169
71866308|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM5 at 500 lux is reported."|Slope|1.92||||0.0481|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0481
71866309|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM10 at 500 lux is reported."|Slope|2.57||||0.0171|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0171
71882603|NCT04152161|143284504|SUPERIORITY||Hazard Ratio (HR)|1.009||||0.5224|TWO_SIDED|95.0|0.73|1.395|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.395|0.730|0.5224
71882604|NCT04152161|143284505|SUPERIORITY||Vaccine Efficacy|-0.049|||||TWO_SIDED|95.0|-0.431|0.23|||||Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)|||0.230|-0.431|
71882605|NCT04152161|143284505|SUPERIORITY||Hazard Ratio (HR)|1.049||||0.6193|TWO_SIDED|95.0|0.77|1.431|||Log Rank|The 1-sided p-value from the log-rank test was stratified by sex and age group.|Calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \>14 years) as stratification variables.|||1.431|0.770|0.6193
71882606|NCT03703102|143284515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
71882607|NCT03703102|143284515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
71882608|NCT03703102|143284515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
71882609|NCT03703102|143284515|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||< 0.001
71882610|NCT05074251|143284550|SUPERIORITY||Risk Ratio (RR)|1.41|||<|0.05|TWO_SIDED|95.0|1.14|1.75|||Regression, Logistic|||||1.75|1.14|<0.05
71882611|NCT03548935|143284570|SUPERIORITY||Treatment difference|-12.44|||<|0.0001|TWO_SIDED|95.0|-13.37|-11.51|||ANCOVA|||Treatment policy estimand||-11.51|-13.37|<.0001
71882612|NCT03548935|143284570|SUPERIORITY||Treatment difference|-14.42|||<|0.0001|TWO_SIDED|95.0|-15.29|-13.55|||ANCOVA|||Hypothetical estimand||-13.55|-15.29|<0.0001
71882613|NCT03548935|143284571|SUPERIORITY||Odds Ratio (OR)|11.22|||<|0.0001|TWO_SIDED|95.0|8.88|14.19|||Regression, Logistic|||Treatment policy estimand||14.19|8.88|<0.0001
71882614|NCT03548935|143284571|SUPERIORITY||Odds Ratio (OR)|37.03|||<|0.0001|TWO_SIDED|95.0|28.02|48.95|||Regression, Logistic|||Hypothetical estimand||48.95|28.02|<0.0001
71882615|NCT00763815|143284612|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.731|-0.386||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.386|-0.731|<0.0001
71882616|NCT02706873|143284635|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|23.7|||<|0.001|TWO_SIDED|95.0|16.3|31.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||31.1|16.3|<0.001
71882617|NCT02706873|143284635|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|28.0|||<|0.001|TWO_SIDED|95.0|20.6|35.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||35.4|20.6|<0.001
71866310|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MM30 at 500 lux is reported."|Slope|3.84||||0.0007|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||0.0007
71911215|NCT03706040|143343196|SUPERIORITY||LS Mean Difference|-5.86|STANDARD_ERROR_OF_MEAN|4.589||0.204|TWO_SIDED|95.0|-14.94|3.22|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.22|-14.94|0.204
71866311|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for dbase at 500 lux is reported."|Slope|-2.15|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866312|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCV at 500 lux is reported."|Slope|-2.2|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866313|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dcon at 500 lux is reported."|Slope|-2.44|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866314|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for Dend at 500 lux is reported."|Slope|-3.01|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866315|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for MCA at 500 lux is reported."|Slope|-1.82|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866316|NCT05731999|143248543|OTHER|"The hypothesis was that k = 0. If the hypothesis could be rejected (p\<0.05), then the pupillometric variable was considered correlated with plasma concentration for the particular key feature, medicinal product and ambient light condition.~Here the p-value for RMCA at 500 lux is reported."|Slope|-1.83|||<|0.0001|TWO_SIDED||||||Regression, Linear|||The correlation between pupillometric variables and concentration in plasma over time for designated medicinal product and ambient light condition was evaluated by collecting all pairs of (key feature value) and (plasma concentration). For each key feature, medicinal product, and ambient light condition, a linear regression was conducted producing an estimate of k and m in the following equation (key feature value) = k \* (plasma concentration) + m||||<0.0001
71866317|NCT05731999|143248545|OTHER||probability|0.000244|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The smallest odds ratio from the group false positives and false negative is reported.||||<0.05
71866318|NCT05731999|143248545|OTHER||probability|0.00586|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
71866319|NCT05731999|143248545|OTHER||probability|0.0193|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
71911216|NCT03706040|143343198|SUPERIORITY||Adjusted Difference|6.7||||0.422|TWO_SIDED|95.0|-9.7|23.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||23.1|-9.7|0.422
71682618|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.493|TWO_SIDED|95.0|-0.88|1.82||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.82|-0.88|0.493
71682619|NCT01149421|142883406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.692|TWO_SIDED|95.0|-1.06|1.6||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||1.60|-1.06|0.692
71682620|NCT01149421|142883406|SUPERIORITY_OR_OTHER|||||||0.99||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.990
71682621|NCT01149421|142883406|SUPERIORITY_OR_OTHER|||||||0.173||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis|||||||0.173
71682622|NCT01149421|142883406|SUPERIORITY_OR_OTHER|||||||0.972||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.972
71682623|NCT01149421|142883406|SUPERIORITY_OR_OTHER|||||||0.904||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis|||||||0.904
71682624|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.49|||<|0.001|TWO_SIDED|95.0|1.17|3.8||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||3.80|1.17|<0.001
71866320|NCT05731999|143248545|OTHER||probability|0.000488|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
71866321|NCT05731999|143248545|OTHER||probability|0.1133|||<|0.05|TWO_SIDED||||||Regression, Logistic|||The null hypothesis is that the logistic regression classifier is unable to correctly classify subjects into sober or under the influence of D1-D4. The greatest p value from the group false positives and false negative is reported.||||<0.05
71682625|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.15||||0.08|TWO_SIDED|95.0|-0.14|2.45||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||2.45|-0.14|0.080
71911217|NCT03706040|143343198|SUPERIORITY||Adjusted Difference|-5.2||||0.505|TWO_SIDED|95.0|-20.3|10.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||10.0|-20.3|0.505
71911218|NCT03706040|143343200|SUPERIORITY||Adjusted Difference|10.1||||0.005|TWO_SIDED|95.0|3.0|17.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||17.3|3.0|0.005
71682626|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.57|||<|0.001|TWO_SIDED|95.0|2.23|4.91||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||4.91|2.23|<0.001
71682627|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92||||0.168|TWO_SIDED|95.0|-0.39|2.24||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||2.24|-0.39|0.168
71682628|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||<|0.001|TWO_SIDED|95.0|2.62|5.28||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||5.28|2.62|<0.001
71682629|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.78|||<|0.001|TWO_SIDED|95.0|1.47|4.09||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||4.09|1.47|<0.001
71682630|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.98|||<|0.001|TWO_SIDED|95.0|2.49|5.47||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||5.47|2.49|<0.001
71682631|NCT01149421|142883407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.003|TWO_SIDED|95.0|0.78|3.7||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||3.70|0.78|0.003
71682632|NCT01149421|142883407|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||<0.001
71682633|NCT01149421|142883407|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis|||||||0.014
71682634|NCT01149421|142883407|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||<0.001
71682635|NCT01149421|142883407|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis|||||||0.005
71682636|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.47|||<|0.001|TWO_SIDED|95.0|-4.5|-2.43||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-2.43|-4.50|<0.001
71682637|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-2.79|-0.75||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-0.75|-2.79|<0.001
71866322|NCT05731999|143248545|OTHER||probability|0.0107|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71866323|NCT01305408|143248572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.2717|TWO_SIDED|95.0|-3.76|1.06||Statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||1.06|-3.76|0.2717
71866324|NCT00799981|143248612|OTHER|||||||0.8762|||||||Wilcoxon (Mann-Whitney)|||The hypothesis that a 10 cm catheter provides equal emptying of the bladder as a 7 cm catheter was tested.||||0.8762
71911219|NCT03706040|143343200|SUPERIORITY||Adjusted Difference|2.9||||0.151|TWO_SIDED|95.0|-1.1|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||6.8|-1.1|0.151
71911220|NCT03706040|143343202|SUPERIORITY||Adjusted Difference|5.9||||0.035|TWO_SIDED|95.0|0.4|11.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.3|0.4|0.035
71866325|NCT00799981|143248613|OTHER|||||||0.7905|||||||McNemar|||||||0.7905
71682638|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4|||<|0.001|TWO_SIDED|95.0|-4.52|-2.28||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-2.28|-4.52|<0.001
71866326|NCT00799981|143248614|OTHER|||||||1|||||||McNemar|||||||1.00
71866327|NCT00799981|143248617|OTHER|||||||0.0273|||||||Wilcoxon (Mann-Whitney)|||In the table 0=No and 1=Yes.||||0.0273
71866328|NCT03653208|143248625|OTHER||Slope|1.01||||0.1075|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.1075
71866329|NCT03653208|143248626|OTHER||Slope|1.2||||0.0548|TWO_SIDED|90.0|||||Kruskal-Wallis|||||||0.0548
71682639|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13|||<|0.001|TWO_SIDED|95.0|-3.23|-1.03||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.03|-3.23|<0.001
71866330|NCT03752970|143248694|OTHER||Risk Difference (RD)|-0.609|||||TWO_SIDED|95.0|-0.88|-0.186||||||||-0.186|-0.880|
71866331|NCT03752970|143248695|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
71682640|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|||<|0.001|TWO_SIDED|95.0|-3.43|-1.07||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||-1.07|-3.43|<0.001
71682641|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.113|TWO_SIDED|95.0|-2.09|0.22||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis|||||0.22|-2.09|0.113
71866332|NCT03752970|143248696|OTHER||Risk Difference (RD)|-0.509|||||TWO_SIDED|95.0|-0.816|-0.087||||||||-0.087|-0.816|
71866333|NCT01669577|143248717|SUPERIORITY_OR_OTHER||GEE(Generalyzed Estimation Equation)|0.989214|||<|0.001|TWO_SIDED|95.0|0.982855|0.995613||arterial hemoglobin Oxygen saturation|ANOVA|Non parametric(NPar) ANOVA|GEE model (dichotomous response variable)with logit link function. The NPar ANOVA (p\<0.1 for death) was the test used for inclusion in the model variables for the final models - backward method, with alpha equal to 0.05.|"significance level of 0.05, power of 0.80, moderate correlation of 0.5 between time periods and assumption that the variability is equal within each factor (non-sphericity). Due to the effect size between 0.1 and 0.5, there was no need for samples larger than 140 patients. A total of 200 patients was defined conservatively, with a margin for possible deaths. The software G\*Power 3.1.7 was used for sample size calculation.~Fischer's test, Mann-Whitney, t-test; Non parametric ANOVA and GEE"||0.995613|0.982855|< 0.001
71866334|NCT01669577|143248717|SUPERIORITY_OR_OTHER||GEE|0.99728|||<|0.001|TWO_SIDED|95.0|0.995791|0.998772|||ANOVA|||diastolic arterial blood pressure||0.998772|0.995791|< 0.001
71866335|NCT01669577|143248717|SUPERIORITY_OR_OTHER||GEE|1.046961|||<|0.004|TWO_SIDED|95.0|1.012521|1.082572|||ANOVA|||lactate||1.082572|1.012521|< 0.004
71866336|NCT01669577|143248717|SUPERIORITY_OR_OTHER||GEE|0.973987|||<|0.001|TWO_SIDED|95.0|0.965308|0.982744|||ANOVA|||Glasgow coma score||0.982744|0.965308|<0.001
71866337|NCT01669577|143248717|SUPERIORITY_OR_OTHER||GEE|1.000013|||<|0.023|TWO_SIDED|95.0|1.0|1.000025|||ANOVA|||amount of Infused crystalloids||1.000025|1.000000|<0.023
71866338|NCT02045875|143248748|SUPERIORITY|||||||0.046||||||Effect of interaction of time and treatment group|ANOVA|||||||0.046
71866339|NCT02045875|143248749|OTHER||correlation coefficient|-0.508|||||TWO_SIDED||||||||correlation of asthma control and adherence|||||
71866340|NCT01114880|143248756|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71866341|NCT01114880|143248758|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71866342|NCT01114880|143248760|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71866343|NCT01114880|143248762|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71866344|NCT01114880|143248764|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71866345|NCT01114880|143248766|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared, Corrected|||||||< 0.001
71866346|NCT01114880|143248768|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71866347|NCT01114880|143248770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71866348|NCT01114880|143248772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||< 0.001
71866349|NCT01114880|143248774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71866350|NCT01114880|143248776|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||< 0.001
71866351|NCT02626455|143248779|SUPERIORITY|Comparison of PFS|Hazard Ratio (HR)|1.125|||=|0.827974|TWO_SIDED|95.0|0.881|1.437||Significance level is 0.025.|Log Rank|PFS was evaluated with a one-sided stratified log- rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.437|0.881|= 0.827974
71866352|NCT02626455|143248782|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-1.25|||=|0.658652|TWO_SIDED|95.0|-7.25|4.75||Significance level is 0.025. P-values are descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||4.75|-7.25|= 0.658652
71866353|NCT02626455|143248783|SUPERIORITY|ORR of Copa+R-B/R-CHOP minus ORR of Pbo+R-B/R-CHOP|Difference|-0.8|||=|0.605183|TWO_SIDED|95.0|-6.64|5.05||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.05|-6.64|=0.605183
71866354|NCT02626455|143248784|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.145|||=|0.846204|TWO_SIDED|95.0|0.883|1.484||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.484|0.883|= 0.846204
71866355|NCT02626455|143248785|SUPERIORITY|Comparison of DOR|Hazard Ratio (HR)|1.117|||=|0.801735|TWO_SIDED|95.0|0.865|1.443||Significance level is 0.025, P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|DOR was evaluated with a one-sided stratified log-rank test. HR and its 95% CI were based on the stratified Cox regression model.||||1.443|0.865|= 0.801735
71866356|NCT02626455|143248786|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.74|||=|0.741153|TWO_SIDED|95.0|-11.06|5.57||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||5.57|-11.06|= 0.741153
71866357|NCT02626455|143248787|SUPERIORITY|CRR of Copa+R-B/R-CHOP minus CRR of Pbo+R-B/R-CHOP|Difference|-2.21|||=|0.696482|TWO_SIDED|95.0|-10.62|6.2||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference.||||6.20|-10.62|= 0.696482
71866358|NCT02626455|143248788|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.95|||=|0.936009|TWO_SIDED|95.0|-9.04|1.14||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||1.14|-9.04|= 0.936009
71911221|NCT03706040|143343202|SUPERIORITY||Adjusted Difference|1.5||||0.311|TWO_SIDED|95.0|-1.4|4.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||4.4|-1.4|0.311
71682642|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74|||<|0.001|TWO_SIDED|95.0|-3.86|-1.62||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-1.62|-3.86|<0.001
71682643|NCT01149421|142883408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.004|TWO_SIDED|95.0|-2.72|-0.51||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis|||||-0.51|-2.72|0.004
71682644|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.128|TWO_SIDED|95.0|-2.22|0.28||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||0.28|-2.22|0.128
71911222|NCT03706040|143343204|SUPERIORITY||Adjusted Difference|-0.3||||0.965|TWO_SIDED|95.0|-12.0|11.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||11.5|-12.0|0.965
71911223|NCT03706040|143343204|SUPERIORITY||Adjusted Difference|-3.1||||0.583|TWO_SIDED|95.0|-14.3|8.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||8.1|-14.3|0.583
71911224|NCT03706040|143343208|SUPERIORITY||Adjusted Difference|5.9||||0.539|TWO_SIDED|95.0|-13.0|24.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||24.9|-13.0|0.539
71911225|NCT03706040|143343208|SUPERIORITY||Adjusted Difference|12.2||||0.213|TWO_SIDED|95.0|-7.0|31.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline disease severity (moderate \[vIGA-AD 3\] versus severe \[vIGA-AD 4\]).|Between Group Difference = Risankizumab - Placebo|||31.5|-7.0|0.213
71911226|NCT03706040|143343210|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.82||0.988|TWO_SIDED|95.0|-3.6|3.6|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||3.6|-3.6|0.988
71911227|NCT03706040|143343210|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.86||0.594|TWO_SIDED|95.0|-4.7|2.7|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||2.7|-4.7|0.594
71911228|NCT03706040|143343214|SUPERIORITY||LS Mean Difference|-1.318|STANDARD_ERROR_OF_MEAN|0.6137||0.033|TWO_SIDED|95.0|-2.531|-0.105|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.105|-2.531|0.033
71911229|NCT03706040|143343214|SUPERIORITY||LS Mean Difference|-1.648|STANDARD_ERROR_OF_MEAN|0.626||0.009|TWO_SIDED|95.0|-2.885|-0.411|||Mixed Effect Model Repeated Measurement|MMRM analysis with treatment, visit, treatment-by-visit interaction, vIGA-AD categories (moderate vs severe) and Baseline value in the model.|Between Group Difference = Risankizumab - Placebo|||-0.411|-2.885|0.009
71911230|NCT03788616|143343224|EQUIVALENCE|assuming 95% power of the study|Median Difference (Final Values)|0.05||||0.478|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.478
71911231|NCT01783470|143343232|EQUIVALENCE|All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||||0.001|||||||Wilcoxon sign-ranks test|||Since the sample size of twelve subjects limited the ability to demonstrate that measurements were normally distributed, we used the non-parametric Wilcoxon sign-ranks test to assess the primary and secondary endpoints. All p values presented are two tailed. p values \< 0.05 were considered to indicate statistical significance for the primary outcome.||||0.001
71911232|NCT01510834|143343234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.824|STANDARD_DEVIATION|14.148||0.001|TWO_SIDED|95.0|-10.578|-3.07|||t-test, 2 sided|||||-3.070|-10.578|.001
71911233|NCT01510834|143343235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0872|STANDARD_DEVIATION|15.731||0.001|TWO_SIDED|95.0|2.91|11.26|||t-test, 2 sided|||||11.26|2.91|.001
71911234|NCT01510834|143343236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.78|STANDARD_DEVIATION|7.78|<|0.001|TWO_SIDED|95.0|-5.84|-1.7|||t-test, 2 sided|||||-1.70|-5.84|<.001
71911235|NCT01510834|143343237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_DEVIATION|6.269||0.015|TWO_SIDED|95.0|-3.751|-0.4244|||t-test, 2 sided|||||-.4244|-3.751|.015
71911236|NCT00527072|143343247|SUPERIORITY_OR_OTHER||Proportion|0.654||||0.05|TWO_SIDED|95.0|0.586|0.718|||exact binomial distribution|||null hypothesis H0: proportion = 0.30||0.718|0.586|0.05
71911237|NCT00527072|143343248|SUPERIORITY_OR_OTHER||proportion|0.791||||0.05|TWO_SIDED|95.0|0.73|0.844|||exact binomial distribution|||||0.844|0.730|0.05
71911238|NCT00527072|143343249|SUPERIORITY_OR_OTHER||proportion|0.646||||0.05|TWO_SIDED|95.0|0.577|0.711|||exact binomial distribution|||||0.711|0.577|0.05
71911239|NCT02980692|143343268|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
71911240|NCT02980692|143343268|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|||||||0.0006
71911241|NCT02980692|143343268|SUPERIORITY|||||||0.0088|||||||Cochran-Mantel-Haenszel|||||||0.0088
71911242|NCT02980692|143343268|SUPERIORITY|||||||0.0041|||||||Cochran-Mantel-Haenszel|||||||0.0041
71911243|NCT02980692|143343269|SUPERIORITY||% response rate|92.54|STANDARD_ERROR_OF_MEAN|3.21|||TWO_SIDED|95.0|86.24|98.83||||||||98.83|86.24|
71911244|NCT02980692|143343269|SUPERIORITY||% response rate|89.06|STANDARD_ERROR_OF_MEAN|3.9|||TWO_SIDED|95.0|81.42|96.71||||||||96.71|81.42|
71911245|NCT02980692|143343269|SUPERIORITY||% response rate|86.67|STANDARD_ERROR_OF_MEAN|4.39|||TWO_SIDED|95.0|78.07|95.27||||||||95.27|78.07|
71911246|NCT02980692|143343269|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
71911247|NCT02980692|143343269|SUPERIORITY||% response rate|81.33|STANDARD_ERROR_OF_MEAN|4.5|||TWO_SIDED|95.0|72.52|90.15||||||||90.15|72.52|
71911248|NCT02980692|143343270|SUPERIORITY||% response rate|79.1|STANDARD_ERROR_OF_MEAN|4.97|||TWO_SIDED|95.0|69.37|88.84||||||||88.84|69.37|
71911249|NCT02980692|143343270|SUPERIORITY||% response rate|75.0|STANDARD_ERROR_OF_MEAN|5.41|||TWO_SIDED|95.0|64.39|85.61||||||||85.61|64.39|
71682645|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.883|TWO_SIDED|95.0|-1.32|1.13||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.13|-1.32|0.883
71682646|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.39|TWO_SIDED|95.0|-1.84|0.72||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.72|-1.84|0.390
71911250|NCT02980692|143343270|SUPERIORITY||% response rate|72.13|STANDARD_ERROR_OF_MEAN|5.74|||TWO_SIDED|95.0|60.88|83.38||||||||83.38|60.88|
71911251|NCT02980692|143343270|SUPERIORITY||% response rate|68.0|STANDARD_ERROR_OF_MEAN|5.39|||TWO_SIDED|95.0|57.44|78.56||||||||78.56|57.44|
71911252|NCT02980692|143343270|SUPERIORITY||% response rate|62.67|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|51.72|73.61||||||||73.61|51.72|
71911253|NCT02980692|143343271|SUPERIORITY||% response rate|58.21|STANDARD_ERROR_OF_MEAN|6.03|||TWO_SIDED|95.0|46.4|70.02||||||||70.02|46.40|
71911254|NCT02980692|143343271|SUPERIORITY||% response rate|48.44|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|36.19|60.68||||||||60.68|36.19|
71911255|NCT02980692|143343271|SUPERIORITY||% response rate|39.34|STANDARD_ERROR_OF_MEAN|6.25|||TWO_SIDED|95.0|27.09|51.6||||||||51.60|27.09|
71911256|NCT02980692|143343271|SUPERIORITY||% response rate|40.0|STANDARD_ERROR_OF_MEAN|5.66|||TWO_SIDED|95.0|28.91|51.09||||||||51.09|28.91|
71911257|NCT02980692|143343271|SUPERIORITY||% response rate|37.33|STANDARD_ERROR_OF_MEAN|5.59|||TWO_SIDED|95.0|26.39|48.28||||||||48.28|26.39|
71911258|NCT02980692|143343272|SUPERIORITY|||||||0.085|||||||Cochran-Mantel-Haenszel|||||||0.0850
71911259|NCT02980692|143343272|SUPERIORITY|||||||0.0234|||||||Cochran-Mantel-Haenszel|||||||0.0234
71911260|NCT02980692|143343272|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||0.0140
71911261|NCT02980692|143343272|SUPERIORITY|||||||0.0731|||||||Cochran-Mantel-Haenszel|||||||0.0731
71911262|NCT02980692|143343273|SUPERIORITY||Mean Difference (Net)|-12.3|STANDARD_DEVIATION|11.47|||TWO_SIDED|||||||||||||
71911263|NCT02980692|143343273|SUPERIORITY||Mean Difference (Net)|-13.7|STANDARD_DEVIATION|11.92|||TWO_SIDED|||||||||||||
71911264|NCT02980692|143343273|SUPERIORITY||Mean Difference (Net)|-16.0|STANDARD_DEVIATION|12.83|||TWO_SIDED|||||||||||||
71911265|NCT02980692|143343273|SUPERIORITY||Mean Difference (Net)|-14.0|STANDARD_DEVIATION|10.65|||TWO_SIDED|||||||||||||
71911266|NCT02980692|143343273|SUPERIORITY||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|12.02|||TWO_SIDED|||||||||||||
71911267|NCT02980692|143343274|SUPERIORITY|||||||0.0111|||||||Cochran-Mantel-Haenszel|||||||0.0111
71911268|NCT02980692|143343274|SUPERIORITY|||||||0.0774|||||||Cochran-Mantel-Haenszel|||||||0.0774
71911269|NCT02980692|143343274|SUPERIORITY|||||||0.019|||||||Cochran-Mantel-Haenszel|||||||0.0190
71911270|NCT02980692|143343274|SUPERIORITY|||||||0.1282|||||||Cochran-Mantel-Haenszel|||||||0.1282
71911271|NCT02980692|143343275|SUPERIORITY||Mean Difference (Net)|-8.7|STANDARD_DEVIATION|6.88|||TWO_SIDED|||||||||||||
71911272|NCT02980692|143343275|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|7.07|||TWO_SIDED|||||||||||||
71911273|NCT02980692|143343275|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|7.62|||TWO_SIDED|||||||||||||
71911274|NCT02980692|143343275|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_DEVIATION|5.78|||TWO_SIDED|||||||||||||
71911275|NCT02980692|143343275|SUPERIORITY||Mean Difference (Net)|-9.0|STANDARD_DEVIATION|8.8|||TWO_SIDED|||||||||||||
71911276|NCT02980692|143343276|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
71911277|NCT02980692|143343276|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
71911278|NCT02980692|143343276|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
71911279|NCT02980692|143343276|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
71911280|NCT02980692|143343277|SUPERIORITY||Mean Difference (Net)|-40.0|STANDARD_DEVIATION|17.38|||TWO_SIDED|||||||||||||
71911281|NCT02980692|143343277|SUPERIORITY||Mean Difference (Net)|-44.3|STANDARD_DEVIATION|19.73|||TWO_SIDED|||||||||||||
71911282|NCT02980692|143343277|SUPERIORITY||Mean Difference (Net)|-45.3|STANDARD_DEVIATION|19.84|||TWO_SIDED|||||||||||||
71911283|NCT02980692|143343277|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|19.18|||TWO_SIDED|||||||||||||
71911284|NCT02980692|143343277|SUPERIORITY||Mean Difference (Net)|-42.0|STANDARD_DEVIATION|20.41|||TWO_SIDED|||||||||||||
71911285|NCT02980692|143343278|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71911286|NCT02980692|143343278|SUPERIORITY|||||||0.0012|||||||Cochran-Mantel-Haenszel|||||||0.0012
71911287|NCT02980692|143343278|SUPERIORITY|||||||0.0011|||||||Cochran-Mantel-Haenszel|||||||0.0011
71911288|NCT02980692|143343278|SUPERIORITY|||||||0.0167|||||||Cochran-Mantel-Haenszel|||||||0.0167
71911289|NCT02980692|143343279|SUPERIORITY||Mean Difference (Net)|-42.2|STANDARD_DEVIATION|22.74|||TWO_SIDED|||||||||||||
71911290|NCT02980692|143343279|SUPERIORITY||Mean Difference (Net)|-43.8|STANDARD_DEVIATION|24.01|||TWO_SIDED|||||||||||||
71911291|NCT02980692|143343279|SUPERIORITY||Mean Difference (Net)|-38.4|STANDARD_DEVIATION|27.9|||TWO_SIDED|||||||||||||
71911292|NCT02980692|143343279|SUPERIORITY||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|24.65|||TWO_SIDED|||||||||||||
71911293|NCT02980692|143343279|SUPERIORITY||Mean Difference (Net)|-40.5|STANDARD_DEVIATION|28.13|||TWO_SIDED|||||||||||||
71911294|NCT02980692|143343280|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71911295|NCT02980692|143343280|SUPERIORITY|||||||0.0055|||||||Cochran-Mantel-Haenszel|||||||0.0055
71911296|NCT02980692|143343280|SUPERIORITY|||||||0.0039|||||||Cochran-Mantel-Haenszel|||||||0.0039
71911297|NCT02980692|143343280|SUPERIORITY|||||||0.0487|||||||Cochran-Mantel-Haenszel|||||||0.0487
71911298|NCT02980692|143343281|SUPERIORITY||Mean Difference (Net)|-40.7|STANDARD_DEVIATION|21.59|||TWO_SIDED|||||||||||||
71911299|NCT02980692|143343281|SUPERIORITY||Mean Difference (Net)|-42.7|STANDARD_DEVIATION|25.67|||TWO_SIDED|||||||||||||
71911300|NCT02980692|143343281|SUPERIORITY||Mean Difference (Net)|-38.0|STANDARD_DEVIATION|29.26|||TWO_SIDED|||||||||||||
71911301|NCT02980692|143343281|SUPERIORITY||Mean Difference (Net)|-37.6|STANDARD_DEVIATION|26.63|||TWO_SIDED|||||||||||||
71911302|NCT02980692|143343281|SUPERIORITY||Mean Difference (Net)|-41.0|STANDARD_DEVIATION|29.83|||TWO_SIDED|||||||||||||
71911303|NCT02980692|143343282|SUPERIORITY|||||||0.0987|||||||Cochran-Mantel-Haenszel|||||||0.0987
71911304|NCT02980692|143343282|SUPERIORITY|||||||0.036|||||||Cochran-Mantel-Haenszel|||||||0.0360
71911305|NCT02980692|143343282|SUPERIORITY|||||||0.0346|||||||Cochran-Mantel-Haenszel|||||||0.0346
71911306|NCT02980692|143343282|SUPERIORITY|||||||0.4442|||||||Cochran-Mantel-Haenszel|||||||0.4442
71682647|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.463|TWO_SIDED|95.0|-1.72|0.79||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||0.79|-1.72|0.463
71866359|NCT02626455|143248789|SUPERIORITY|DCR of Copa+R-B/R-CHOP minus DCR of Pbo+R-B/R-CHOP|Difference|-3.89|||=|0.944242|TWO_SIDED|95.0|-8.68|0.9||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Cochran-Mantel-Haenszel|Point estimate and 95% CI are based on Mantel-Haenszel weighted treatment difference||||0.90|-8.68|= 0.944242
71866360|NCT02626455|143248790|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|1.006|||=|0.517849|TWO_SIDED|95.0|0.777|1.303||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.303|0.777|= 0.517849
71911307|NCT02980692|143343283|SUPERIORITY||Mean Difference (Net)|-0.4869|STANDARD_DEVIATION|0.52093|||TWO_SIDED|||||||||||||
71911308|NCT02980692|143343283|SUPERIORITY||Mean Difference (Net)|-0.543|STANDARD_DEVIATION|0.59145|||TWO_SIDED|||||||||||||
71911309|NCT02980692|143343283|SUPERIORITY||Mean Difference (Net)|-0.4857|STANDARD_DEVIATION|0.56968|||TWO_SIDED|||||||||||||
71911310|NCT02980692|143343283|SUPERIORITY||Mean Difference (Net)|-0.4583|STANDARD_DEVIATION|0.52285|||TWO_SIDED|||||||||||||
71911311|NCT02980692|143343283|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.54013|||TWO_SIDED|||||||||||||
71911312|NCT02980692|143343284|SUPERIORITY|||||||0.0064|||||||Cochran-Mantel-Haenszel|||||||0.0064
71911313|NCT02980692|143343284|SUPERIORITY|||||||0.0516|||||||Cochran-Mantel-Haenszel|||||||0.0516
71911314|NCT02980692|143343284|SUPERIORITY|||||||0.0114|||||||Cochran-Mantel-Haenszel|||||||0.0114
71911315|NCT02980692|143343284|SUPERIORITY|||||||0.082|||||||Cochran-Mantel-Haenszel|||||||0.0820
71911316|NCT02980692|143343285|SUPERIORITY||Mean Difference (Net)|-3.43|STANDARD_DEVIATION|12.506|||TWO_SIDED|||||||||||||
71911317|NCT02980692|143343285|SUPERIORITY||Mean Difference (Net)|-3.68|STANDARD_DEVIATION|10.77|||TWO_SIDED|||||||||||||
71911318|NCT02980692|143343285|SUPERIORITY||Mean Difference (Net)|-6.05|STANDARD_DEVIATION|19.004|||TWO_SIDED|||||||||||||
71911319|NCT02980692|143343285|SUPERIORITY||Mean Difference (Net)|-4.61|STANDARD_DEVIATION|9.508|||TWO_SIDED|||||||||||||
71911320|NCT02980692|143343285|SUPERIORITY||Mean Difference (Net)|-6.75|STANDARD_DEVIATION|19.649|||TWO_SIDED|||||||||||||
71911321|NCT02980692|143343286|SUPERIORITY|||||||0.0351|||||||Cochran-Mantel-Haenszel|||||||0.0351
71911322|NCT02980692|143343286|SUPERIORITY|||||||0.0876|||||||Cochran-Mantel-Haenszel|||||||0.0876
71911323|NCT02980692|143343286|SUPERIORITY|||||||0.0269|||||||Cochran-Mantel-Haenszel|||||||0.0269
71911324|NCT02980692|143343286|SUPERIORITY|||||||0.0185|||||||Cochran-Mantel-Haenszel|||||||0.0185
71911325|NCT02980692|143343287|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|19.58|||TWO_SIDED|||||||||||||
71911326|NCT02980692|143343287|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_DEVIATION|15.26|||TWO_SIDED|||||||||||||
71911327|NCT02980692|143343287|SUPERIORITY||Median Difference (Net)|-8.9|STANDARD_DEVIATION|20.48|||TWO_SIDED|||||||||||||
71911328|NCT02980692|143343287|SUPERIORITY||Mean Difference (Net)|-9.7|STANDARD_DEVIATION|19.02|||TWO_SIDED|||||||||||||
71911329|NCT02980692|143343287|SUPERIORITY||Mean Difference (Net)|-9.2|STANDARD_DEVIATION|20.47|||TWO_SIDED|||||||||||||
71911330|NCT02980692|143343288|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
71911331|NCT02980692|143343288|SUPERIORITY||Proportion with Adjustment of Background|1.3|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|95.0|0.0|3.83||||||||3.83|0.00|
71911332|NCT02980692|143343288|SUPERIORITY||Proportion with Adjustment of Background|2.56|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|95.0|0.0|6.07||||||||6.07|0.00|
71911333|NCT02980692|143343288|SUPERIORITY||Proportion with Adjustment of Background|1.27|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|95.0|0.0|3.73||||||||3.73|0.00|
71911334|NCT02980692|143343289|SUPERIORITY||% response rate|85.07|STANDARD_ERROR_OF_MEAN|4.35|||TWO_SIDED|95.0|76.54|93.61||||||||93.61|76.54|
71911335|NCT02980692|143343289|SUPERIORITY||% response rate|81.25|STANDARD_ERROR_OF_MEAN|4.88|||TWO_SIDED|95.0|71.69|90.81||||||||90.81|71.69|
71866361|NCT02626455|143248791|SUPERIORITY|Comparison of TTP|Hazard Ratio (HR)|0.971|||=|0.411398|TWO_SIDED|95.0|0.75|1.257||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTP was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.257|0.750|= 0.411398
71866362|NCT02626455|143248792|SUPERIORITY|Comparison of TTNT|Hazard Ratio (HR)|1.289|||=|0.955865|TWO_SIDED|95.0|0.962|1.728||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|TTNT was evaluated with a one-sided stratified log-rank test. HR and its 95% CI are based on the stratified Cox regression model.||||1.728|0.962|= 0.955865
71911336|NCT02980692|143343289|SUPERIORITY||% response rate|76.27|STANDARD_ERROR_OF_MEAN|5.54|||TWO_SIDED|95.0|65.42|87.13||||||||87.13|65.42|
71911337|NCT02980692|143343289|SUPERIORITY||% response rate|71.05|STANDARD_ERROR_OF_MEAN|5.2|||TWO_SIDED|95.0|60.86|81.25||||||||81.25|60.86|
71911338|NCT02980692|143343289|SUPERIORITY||% response rate|65.33|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|54.56|76.1||||||||76.10|54.56|
71911339|NCT02980692|143343290|SUPERIORITY||% response rate|56.92|STANDARD_ERROR_OF_MEAN|6.14|||TWO_SIDED|95.0|44.88|68.96||||||||68.96|44.88|
71911340|NCT02980692|143343290|SUPERIORITY||% response rate|64.41|STANDARD_ERROR_OF_MEAN|6.23|||TWO_SIDED|95.0|52.19|76.62||||||||76.62|52.19|
71911341|NCT02980692|143343290|SUPERIORITY||% response rate|45.0|STANDARD_ERROR_OF_MEAN|6.42|||TWO_SIDED|95.0|32.41|57.59||||||||57.59|32.41|
71911342|NCT02980692|143343290|SUPERIORITY||% response rate|47.06|STANDARD_ERROR_OF_MEAN|6.05|||TWO_SIDED|95.0|35.2|58.92||||||||58.92|35.20|
71911343|NCT02980692|143343290|SUPERIORITY||% response rate|42.03|STANDARD_ERROR_OF_MEAN|5.94|||TWO_SIDED|95.0|30.38|53.68||||||||53.68|30.38|
71911344|NCT02980692|143343291|SUPERIORITY|||||||0.7081|||||||Cochran-Mantel-Haenszel|||||||0.7081
71911345|NCT02980692|143343291|SUPERIORITY|||||||0.9244|||||||Cochran-Mantel-Haenszel|||||||0.9244
71911346|NCT02980692|143343291|SUPERIORITY|||||||0.5365|||||||Cochran-Mantel-Haenszel|||||||0.5365
71911347|NCT02980692|143343291|SUPERIORITY|||||||0.2925|||||||Cochran-Mantel-Haenszel|||||||0.2925
71911348|NCT02980692|143343292|SUPERIORITY||Mean Difference (Net)|-14.453|STANDARD_DEVIATION|31.9358|||TWO_SIDED|||||||||||||
71911349|NCT02980692|143343292|SUPERIORITY||Mean Difference (Net)|-18.883|STANDARD_DEVIATION|57.1147|||TWO_SIDED|||||||||||||
71682648|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.671|TWO_SIDED|95.0|-1.13|1.76||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.76|-1.13|0.671
71682649|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.471|TWO_SIDED|95.0|-0.9|1.95||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis|||||1.95|-0.90|0.471
71866363|NCT02626455|143248793|SUPERIORITY|Comparison of OS|Hazard Ratio (HR)|1.132|||=|0.758563|TWO_SIDED|95.0|0.8|1.603||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|OS was evaluated with a one-sided stratified log-rank test. HR and 95% CI are based on the stratified Cox regression model.||||1.603|0.800|= 0.758563
71866364|NCT02626455|143248794|SUPERIORITY|Comparison of time to deterioration in DRS-P|Hazard Ratio (HR)|1.394|||=|0.999695|TWO_SIDED|95.0|1.149|1.691||Significance level IS 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to deterioration in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on stratified Cox regression model.||||1.691|1.149|= 0.999695
71866365|NCT02626455|143248795|SUPERIORITY|Comparison of time to improvement in DRS-P|Hazard Ratio (HR)|0.81|||=|0.965639|TWO_SIDED|95.0|0.642|1.02||Significance level is 0.025. P-value is descriptive (nominal) due to multiplicity testing.|Log Rank|Time to improvement in DRS-P was evaluated with one-sided stratified log-rank test.HR and its 95% CI are based on the stratified Cox regression model.||||1.020|0.642|= 0.965639
71866366|NCT01882543|143248821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.061|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||A sample size of 28 subjects per group had 80% power to detect a 1.5-point difference in the change from baseline pain score between AQX-1125 and placebo assuming a between-subject SD of 2.0 and a 2-sided 5% significance level. Average daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the primary efficacy end point of average daily pain score||0.0|-2.1|0.061
71866367|NCT01882543|143248822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.03|TWO_SIDED|95.0|-2.5|-0.1|||ANCOVA|||E-diary maximum daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the secondary efficacy variable of maximum daily pain score||-0.1|-2.5|0.030
71866368|NCT01882543|143248823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.008|TWO_SIDED|95.0|-2.8|-0.5|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-2.8|0.008
71866369|NCT01882543|143248824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.028|TWO_SIDED|95.0|-3.0|-0.2|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.2|-3.0|0.028
71866370|NCT01882543|143248825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.4||||0.011|TWO_SIDED|95.0|-9.5|-1.3|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.3|-9.5|0.011
71682650|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.543|TWO_SIDED|95.0|-1.95|1.03||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.03|-1.95|0.543
71682651|NCT01149421|142883409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.728|TWO_SIDED|95.0|-1.72|1.2||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis|||||1.20|-1.72|0.728
71682652|NCT01149421|142883422|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||<0.001
71866371|NCT01882543|143248826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.007|TWO_SIDED|95.0|-8.8|-1.4||ICSI/PI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-1.4|-8.8|0.007
71866372|NCT01882543|143248826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.005|TWO_SIDED|95.0|-4.6|-0.9||ICSI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.9|-4.6|0.005
71866373|NCT01882543|143248826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.5||||0.014|TWO_SIDED|95.0|-4.5|-0.5||ICPI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.5|-4.5|0.014
71866374|NCT01882543|143248827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.592|TWO_SIDED|95.0|-6.3|3.6||Mental Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||3.6|-6.3|0.592
71866375|NCT01882543|143248827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5||||0.221|TWO_SIDED|95.0|-1.6|6.7||Physical Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.||6.7|-1.6|0.221
71866376|NCT01882543|143248828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.8||||0.04|TWO_SIDED|95.0|-5.5|-0.1|||ANOVA|||Analyses of the secondary variable was based on observed data without imputation.||-0.1|-5.5|0.040
71682653|NCT01149421|142883422|SUPERIORITY_OR_OTHER|||||||0.005||||||Treatment comparison at 16 weeks.|Mixed Models Analysis|||||||0.005
71682654|NCT01149421|142883422|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||<0.001
71682655|NCT01149421|142883422|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||||0.012
71682656|NCT04108988|142883429|SUPERIORITY|||||||0.248|||||||Chi-squared|||P value at 4 months||||0.248
71682657|NCT04108988|142883429|SUPERIORITY|||||||0.022|||||||Chi-squared|||P value at 1 month||||0.022
71682658|NCT04108988|142883429|SUPERIORITY|||||||0.193|||||||Chi-squared|||P value at baseline||||0.193
71682659|NCT04108988|142883430|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at 4 months||||0.246
71682660|NCT04108988|142883430|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at 1 month||||0.467
71682661|NCT04108988|142883430|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline||||0.550
71682662|NCT04108988|142883431|SUPERIORITY|||||||0.596|||||||Chi-squared|||P value at month 4||||0.596
71682663|NCT04108988|142883431|SUPERIORITY|||||||0.974|||||||Chi-squared|||P value at 1 month||||0.974
71682664|NCT04108988|142883431|SUPERIORITY|||||||0.651|||||||Chi-squared|||P value at baseline.||||0.651
71682665|NCT04108988|142883432|SUPERIORITY|||||||0.089|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.089
71682666|NCT04108988|142883433|SUPERIORITY|||||||0.095|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.095
71682667|NCT04108988|142883434|SUPERIORITY|||||||0.136|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.136
71682668|NCT04108988|142883435|SUPERIORITY|||||||0.133|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.133
71682669|NCT04108988|142883436|SUPERIORITY|||||||0.21|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.210
71682670|NCT04108988|142883437|SUPERIORITY|||||||0.392|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.392
71682671|NCT04108988|142883438|SUPERIORITY|||||||0.411|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.411
71682672|NCT04108988|142883439|SUPERIORITY|||||||0.294|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.294
71911350|NCT02980692|143343292|SUPERIORITY||Mean Difference (Net)|-27.084|STANDARD_DEVIATION|76.2272|||TWO_SIDED|||||||||||||
71911351|NCT02980692|143343292|SUPERIORITY||Mean Difference (Net)|-26.173|STANDARD_DEVIATION|87.5367|||TWO_SIDED|||||||||||||
71911352|NCT02980692|143343292|SUPERIORITY||Mean Difference (Net)|-50.399|STANDARD_DEVIATION|141.677|||TWO_SIDED|||||||||||||
71911353|NCT02980692|143343293|SUPERIORITY|||||||0.0203|||||||Cochran-Mantel-Haenszel|||||||0.0203
71911354|NCT02980692|143343293|SUPERIORITY|||||||0.5194|||||||Cochran-Mantel-Haenszel|||||||0.5194
71911355|NCT02980692|143343293|SUPERIORITY|||||||0.0599|||||||Cochran-Mantel-Haenszel|||||||0.0599
71911356|NCT02980692|143343293|SUPERIORITY|||||||0.122|||||||Cochran-Mantel-Haenszel|||||||0.1220
71911357|NCT02980692|143343294|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_DEVIATION|1.86|||TWO_SIDED|||||||||||||
71911358|NCT02980692|143343294|SUPERIORITY||Mean Difference (Net)|-1.0|STANDARD_DEVIATION|1.56|||TWO_SIDED|||||||||||||
71911359|NCT02980692|143343294|SUPERIORITY||Mean Difference (Net)|-1.7|STANDARD_DEVIATION|2.08|||TWO_SIDED|||||||||||||
71911360|NCT02980692|143343294|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.75|||TWO_SIDED|||||||||||||
71911361|NCT02980692|143343294|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_DEVIATION|1.82|||TWO_SIDED|||||||||||||
71911362|NCT01819506|143343313|SUPERIORITY|||||||0.912|||||||ANOVA|||||||0.912
71911363|NCT03000686|143343316|OTHER||Median Difference (Net)|0.021|STANDARD_DEVIATION|1.1339|||TWO_SIDED|95.0|-2.249|2.295|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||2.295|-2.249|
71911364|NCT03000686|143343316|OTHER||Median Difference (Net)|-4.021|STANDARD_DEVIATION|2.5923|||TWO_SIDED|95.0|-9.168|1.146|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||1.146|-9.168|
71911365|NCT03000686|143343316|OTHER||Median Difference (Net)|-1.668|STANDARD_DEVIATION|4.4927|||TWO_SIDED|95.0|-10.576|7.231|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise|||7.231|-10.576|
71911366|NCT03000686|143343316|OTHER||Median Difference (Net)|-0.824|STANDARD_DEVIATION|1.6695|||TWO_SIDED|95.0|-4.142|2.506|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||2.506|-4.142|
71911367|NCT03000686|143343317|OTHER||Median Difference (Net)|-0.662|STANDARD_DEVIATION|2.1933|||TWO_SIDED|95.0|-5.037|3.815|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion|||3.815|-5.037|
71911368|NCT03000686|143343317|OTHER||Median Difference (Net)|-2.796|STANDARD_DEVIATION|3.4297|||TWO_SIDED|95.0|-9.729|4.027|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.|||4.027|-9.729|
71911369|NCT03000686|143343317|OTHER||Median Difference (Net)|-0.018|STANDARD_DEVIATION|4.145|||TWO_SIDED|95.0|-8.475|8.086|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start|||8.086|-8.475|
71911370|NCT03000686|143343317|OTHER||Median Difference (Net)|-0.291|STANDARD_DEVIATION|2.3277|||TWO_SIDED|95.0|-4.96|4.386|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit|||4.386|-4.960|
71911371|NCT03000686|143343324|OTHER||Median Difference (Net)|-0.148|STANDARD_DEVIATION|0.5622|||TWO_SIDED|95.0|-1.264|0.973|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||0.973|-1.264|
71911372|NCT03000686|143343324|OTHER||Median Difference (Net)|-1.172|STANDARD_DEVIATION|2.072|||TWO_SIDED|95.0|-5.271|2.942|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||2.942|-5.271|
71866377|NCT00926497|143248840|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|||The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.||||0.002
71911373|NCT03000686|143343324|OTHER||Median Difference (Net)|-0.169|STANDARD_DEVIATION|2.2351|||TWO_SIDED|95.0|-4.624|4.258|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.|||4.258|-4.624|
71911374|NCT03000686|143343324|OTHER||Median Difference (Net)|-0.367|STANDARD_DEVIATION|0.5649|||TWO_SIDED|95.0|-1.498|0.753|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.753|-1.498|
71911375|NCT03000686|143343325|OTHER||Median Difference (Net)|0.203|STANDARD_DEVIATION|0.8872|||TWO_SIDED|95.0|-1.578|1.968|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.|||1.968|-1.578|
71911376|NCT03000686|143343325|OTHER||Median Difference (Net)|3.76|STANDARD_DEVIATION|1.8799|||TWO_SIDED|95.0|-0.001|7.495|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.|||7.495|-0.001|
71911377|NCT03000686|143343325|OTHER||Median Difference (Net)|-1.029|STANDARD_DEVIATION|2.8146|||TWO_SIDED|95.0|-6.673|4.578|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.|||4.578|-6.673|
71911378|NCT03000686|143343325|OTHER||Median Difference (Net)|-0.873|STANDARD_DEVIATION|0.762|||TWO_SIDED|95.0|-2.38|0.669|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.|||0.669|-2.380|
71911379|NCT04153929|143343390|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911380|NCT04153929|143343390|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911381|NCT04153929|143343390|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911382|NCT04153929|143343390|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911383|NCT04153929|143343390|OTHER|Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71866378|NCT00926497|143248841|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|||||||0.012
71682673|NCT04108988|142883440|SUPERIORITY|||||||0.031|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.031
71866379|NCT00926497|143248841|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.004
71866380|NCT00574873|143248915|SUPERIORITY_OR_OTHER|||||||0.667||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.667
71866381|NCT00574873|143248916|SUPERIORITY_OR_OTHER|||||||0.002||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel|||||||0.002
71911384|NCT04153929|143343390|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.76|||<|0.0001|TWO_SIDED|95.0|-1.06|-0.46||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.46|-1.06|<0.0001
71922246|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|4.54|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|1.27|7.81|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 7||7.81|1.27|
71866382|NCT00574873|143248917|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.31|1.31|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.31|0.31|
71866383|NCT00574873|143248918|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.32|1.08|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||1.08|0.32|
71866384|NCT00574873|143248919|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.25|||||TWO_SIDED|95.0|0.9|11.72|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.|||11.72|0.90|
71866385|NCT00574873|143248920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.13|1.29|||||The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.|||1.29|0.13|
71866386|NCT00201643|143248921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|STANDARD_ERROR_OF_MEAN|0.1162||0.002|TWO_SIDED|95.0|0.27|0.75||Analysis were also conducted in all randomized women with a known outcome \& in randomized treatment group(modified intent to treat). Analysis of the primary outcome used a repeated measures approach where each baby was considered a repeated measure|Fisher Exact|||Our Hypothesis was that administration of a rescue ACS would show a 40% reduction in incidence of composite neonatal morbity in patients delivering \< 34 weeks. Sample size estimates based on composite morbidity of 28%. Each arm required 217 subjects to have 80% power to detect a 40% reduction to 16.8%(2-tailed,alpha =0.05)using comparison for proportions/groups(Fisher exact test) OR,95% CI \& P values were determined using a repeated measure model where each twin is considered a repeat measure.||0.75|0.27|0.002
71866387|NCT01638429|143248953|SUPERIORITY_OR_OTHER|||||||0.16|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.16
71866388|NCT01638429|143248955|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.028
71866389|NCT01638429|143248956|SUPERIORITY_OR_OTHER|||||||0.01|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment||||0.01
71866390|NCT01638429|143248957|SUPERIORITY_OR_OTHER|||||||0.97|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.97
71866391|NCT01638429|143248957|SUPERIORITY_OR_OTHER|||||||0.85|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.85
71866392|NCT01638429|143248958|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.61
71866393|NCT01638429|143248958|SUPERIORITY_OR_OTHER|||||||0.45|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.45
71866394|NCT01638429|143248959|SUPERIORITY_OR_OTHER|||||||0.018|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.018
71866395|NCT01638429|143248959|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.14
71866396|NCT01638429|143248960|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.43
71866397|NCT01638429|143248960|SUPERIORITY_OR_OTHER|||||||0.44|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.44
71866398|NCT01638429|143248961|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.13
71866399|NCT01638429|143248961|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.25
71866400|NCT01638429|143248962|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.29
71866401|NCT01638429|143248962|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.27
71866402|NCT01638429|143248963|SUPERIORITY_OR_OTHER|||||||0.22|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.22
71866403|NCT01638429|143248963|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.059
71866404|NCT01638429|143248964|SUPERIORITY_OR_OTHER|||||||0.33|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment||||0.33
71866405|NCT01638429|143248964|SUPERIORITY_OR_OTHER|||||||0.075|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment||||0.075
71922247|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.94|||TWO_SIDED|95.0|-1.45|6.61|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.61|-1.45|
71682674|NCT04108988|142883441|SUPERIORITY|||||||0.262|||||||ANOVA|Test for the interaction between treatment and time||Test of interaction with treatment and time.||||0.262
71922248|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|3.17|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|95.0|-0.78|7.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.11|-0.78|
71922249|NCT03091920|143365005|OTHER|No statistical testing was performed.|Least squares mean difference|2.87|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|95.0|-0.71|6.45|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 14||6.45|-0.71|
71922250|NCT03091920|143365006|OTHER|No statistical testing was performed.|Least squares mean difference|2.17|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.65|6.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.99|-2.65|
71922251|NCT03091920|143365006|OTHER|No statistical testing was performed.|Least squares mean difference|4.09|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-0.73|8.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||8.91|-0.73|
71922252|NCT03091920|143365006|OTHER|No statistical testing was performed.|Least squares mean difference|4.56|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.6|8.51|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||8.51|0.60|
71922253|NCT03091920|143365006|OTHER|No statistical testing was performed.|Least squares mean difference|4.02|STANDARD_ERROR_OF_MEAN|1.91|||TWO_SIDED|95.0|0.07|7.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||7.98|0.07|
71922254|NCT03091920|143365006|OTHER|No statistical testing was performed.|Least squares mean difference|3.12|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|-1.15|7.39|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.39|-1.15|
71922255|NCT03091920|143365006|OTHER|No statistical testing was performed.|Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|2.01|||TWO_SIDED|95.0|-0.44|7.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.92|-0.44|
71922256|NCT03091920|143365007|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|1.54|||TWO_SIDED|95.0|1.1|7.49|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||7.49|1.10|
71922257|NCT03091920|143365007|OTHER|No statistical testing was performed.|Least squares mean difference|2.94|STANDARD_ERROR_OF_MEAN|1.53|||TWO_SIDED|95.0|-0.23|6.1|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1||6.10|-0.23|
71922258|NCT03091920|143365007|OTHER|No statistical testing was performed.|Least squares mean difference|4.8|STANDARD_ERROR_OF_MEAN|2.07|||TWO_SIDED|95.0|0.5|9.11|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.11|0.50|
71922259|NCT03091920|143365007|OTHER|No statistical testing was performed.|Least squares mean difference|5.1|STANDARD_ERROR_OF_MEAN|2.05|||TWO_SIDED|95.0|0.84|9.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7||9.36|0.84|
71922260|NCT03091920|143365007|OTHER|No statistical testing was performed.|Least squares mean difference|1.89|STANDARD_ERROR_OF_MEAN|2.32|||TWO_SIDED|95.0|-2.93|6.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||6.70|-2.93|
71922261|NCT03091920|143365007|OTHER|No statistical testing was performed.|Least squares mean difference|2.55|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.15|7.25|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14||7.25|-2.15|
71922262|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|6.81|STANDARD_ERROR_OF_MEAN|2.61|||TWO_SIDED|95.0|1.4|12.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||12.22|1.40|
71922263|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|1.12|11.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 0-4 hours||11.99|1.12|
71922264|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|-0.95|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-8.18|6.28|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||6.28|-8.18|
71922265|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|1.85|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|-5.39|9.09|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 4-8 hours||9.09|-5.39|
71922266|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-5.98|5.23|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||5.23|-5.98|
71922267|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|3.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|95.0|-2.5|8.7|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 8-12 hours||8.70|-2.50|
71682675|NCT04108988|142883442|SUPERIORITY|||||||0.116|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.116
71682676|NCT04108988|142883443|SUPERIORITY|||||||0.016|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.016
71911385|NCT04153929|143343390|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.31|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.01||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.01|-1.60|<0.0001
71911386|NCT04153929|143343390|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.56|||<|0.0001|TWO_SIDED|95.0|-1.87|-1.26||P-value is considered nominal.|Mixed Model for Repeated Measures|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.26|-1.87|<0.0001
71911387|NCT04153929|143343390|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.1||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.10|-1.72|<0.0001
71911388|NCT04153929|143343390|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.49|||<|0.0001|TWO_SIDED|95.0|-1.78|-1.19||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.19|-1.78|<0.0001
71911389|NCT04153929|143343390|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.53|||<|0.0001|TWO_SIDED|95.0|-1.84|-1.22||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 5, 8, 12, 16 and 17) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.22|-1.84|<0.0001
71911390|NCT04153929|143343391|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod linear model fit|Model assumption: The maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911391|NCT04153929|143343391|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod exponential model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71682677|NCT04108988|142883444|SUPERIORITY|||||||0.667|||||||ANOVA|Test for the interaction between treatment and time.||Test for the interaction between treatment and time.||||0.667
71682678|NCT04108988|142883445|SUPERIORITY|||||||0.09|||||||Chi-squared|||P value at month 4||||0.09
71682679|NCT04108988|142883445|SUPERIORITY|||||||0.72|||||||Chi-squared|||P value 1 month||||0.72
71682680|NCT04108988|142883445|SUPERIORITY|||||||0.97|||||||Chi-squared|||P value at baseline||||0.97
71682681|NCT04108988|142883446|SUPERIORITY|||||||0.53|||||||Chi-squared|||P value at month 4||||0.53
71911392|NCT04153929|143343391|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 1 model fit|Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911393|NCT04153929|143343391|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Emax 2 model fit|Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911394|NCT04153929|143343391|OTHER|"Mixed Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod.~MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements."|||||<|0.0001|||||||MCP-Mod Sigmoid Emax model fit|Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.||A flat vs. non-flat dose-response relationship across the 6 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.025). For the twice weekly dosing schemes the total dose per week was considered for the MCP-Mod analysis.||||<0.0001
71911395|NCT04153929|143343391|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.11||||0.2228|TWO_SIDED|95.0|-2.9|0.68||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.68|-2.90|0.2228
71911396|NCT04153929|143343391|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.79|||<|0.0001|TWO_SIDED|95.0|-5.56|-2.01||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.01|-5.56|<0.0001
71911397|NCT04153929|143343391|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.61|||<|0.0001|TWO_SIDED|95.0|-7.41|-3.81||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.81|-7.41|<0.0001
71911398|NCT04153929|143343391|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.12|-4.38||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.38|-8.12|<0.0001
71682682|NCT04108988|142883446|SUPERIORITY|||||||0.303|||||||Chi-squared|||P value at month 1||||0.303
71682683|NCT04108988|142883446|SUPERIORITY|||||||0.042|||||||Chi-squared|||P value at baseline.||||0.042
71682684|NCT04108988|142883447|SUPERIORITY|||||||0.246|||||||Chi-squared|||P value at month 4.||||0.246
71682685|NCT04108988|142883447|SUPERIORITY|||||||0.467|||||||Chi-squared|||P value at month 1.||||0.467
71682686|NCT04108988|142883447|SUPERIORITY|||||||0.55|||||||Chi-squared|||P value at baseline.||||0.55
71682687|NCT04108988|142883448|SUPERIORITY|||||||0.987|||||||Chi-squared|||P value at month 4.||||0.987
71682688|NCT04108988|142883448|SUPERIORITY|||||||0.898|||||||Chi-squared|||P value at month 1.||||0.898
71682689|NCT04108988|142883448|SUPERIORITY|||||||0.238|||||||Chi-squared|||P value at baseline.||||0.238
71682690|NCT04108988|142883449|SUPERIORITY|||||||0.148|||||||Chi-squared|||P value at month 4.||||0.148
71682691|NCT04108988|142883449|SUPERIORITY|||||||0.557|||||||Chi-squared|||P value at month 1.||||0.557
71682692|NCT04108988|142883450|SUPERIORITY|||||||0.653|||||||Chi-squared|||||||0.653
71682693|NCT04108988|142883451|SUPERIORITY|||||||0.977|||||||Chi-squared|||||||0.977
71866406|NCT02040584|143248973|SUPERIORITY_OR_OTHER|||||||0.9423|||||||Fisher Exact|Week 52||"Null hypothesis (H0): there were no differences in kidney function between the two groups, in contrast with the alternative hypothesis (H1), in which there were differences:~HO: CBS = CBC versus H1: CBS ≠ CBC, where CBS and CBC were percentages of patients who showed clinical benefit at Week 52 for the study group and control group, respectively."||||0.9423
71866407|NCT00996476|143248984|SUPERIORITY_OR_OTHER||LS means difference|-2.4|||||TWO_SIDED|95.0|-2.83|-1.97|||ANCOVA||TMC435 50 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.97|-2.83|
71866408|NCT00996476|143248984|SUPERIORITY_OR_OTHER||LS Means difference|-2.41|||||TWO_SIDED|95.0|-2.85|-1.98|||ANCOVA||TMC435 100 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group||-1.98|-2.85|
71866409|NCT00996476|143248989|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-24.6|||||TWO_SIDED|95.0|-58.3|11.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group||11.8|-58.3|
71866410|NCT00996476|143248989|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-27.5|||||TWO_SIDED|95.0|-61.1|9.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group||9.8|-61.1|
71866411|NCT00996476|143248989|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-23.3|||||TWO_SIDED|95.0|-59.9|19.4|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group||19.4|-59.9|
71866412|NCT00996476|143248989|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-32.3|||||TWO_SIDED|95.0|-66.6|8.3|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group||8.3|-66.6|
71911399|NCT04153929|143343391|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-6.25|||<|0.0001|TWO_SIDED|95.0|-8.02|-4.47||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.47|-8.02|<0.0001
71911400|NCT04153929|143343391|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.68|||<|0.0001|TWO_SIDED|95.0|-9.52|-5.83||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.83|-9.52|<0.0001
71911401|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.66||||0.4439|TWO_SIDED|95.0|-2.34|1.03||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.03|-2.34|0.4439
71911402|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.28||||0.0001|TWO_SIDED|95.0|-4.95|-1.61||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-1.61|-4.95|0.0001
71911403|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.93|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.23||P-value is considered nominal|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.23|-6.62|<0.0001
71911404|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.76|||<|0.0001|TWO_SIDED|95.0|-7.53|-4.0||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-4.00|-7.53|<0.0001
71922268|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|6.46|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|95.0|2.02|10.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||10.89|2.02|
71682694|NCT04108988|142883452|SUPERIORITY|||||||0.735|||||||t-test, 2 sided|||P value at month 4.||||0.735
71682695|NCT04108988|142883452|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||P value at month 1.||||0.159
71682696|NCT04108988|142883453|SUPERIORITY|||||||3.19|||||||t-test, 2 sided|||P value at month 4.||||3.19
71682697|NCT04108988|142883453|SUPERIORITY|||||||0.487|||||||t-test, 2 sided|||P value at month 1.||||0.487
71866413|NCT05540717|143248998|SUPERIORITY||relative difference (%)|-20.25||||0.00048|TWO_SIDED|95.0|-31.0|-9.49|||Mixed Models Analysis|||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-9.49|-31.0|0.00048
71866414|NCT05540717|143248999|SUPERIORITY||relative difference (%)|-20.2||||0.00032|TWO_SIDED|95.0|-30.13|-10.27|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect||-10.27|-30.13|0.00032
71866415|NCT05540717|143249000|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-26.54||||0.0008|TWO_SIDED|95.0|-41.15|-11.94|||Mixed Models Analysis|||Comparison of dMS of CSMS on peak GPS||-11.94|-41.15|0.00080
71866416|NCT05540717|143249000|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect.|relative difference (%)|-26.6||||0.00031|TWO_SIDED|95.0|-40.49|-12.72|||Mixed Models Analysis|||Comparison of dMS of CSMS on entire GPS||-12.72|-40.49|0.00031
71866417|NCT05540717|143249001|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.35||||0.00223|TWO_SIDED|95.0|-26.27|-6.44|||Mixed Models Analysis|||Comparison of dSS of CSMS on peak GPS||-6.44|-26.27|0.00223
71866418|NCT05540717|143249001|SUPERIORITY|Linear mixed model using treatment group as fixed effect and pooled geographical region as random effect|relative difference (%)|-16.58||||0.00076|TWO_SIDED|95.0|||||Mixed Models Analysis|||Comparison of dSS of CSMS on entire GPS||||0.00076
71866419|NCT05540717|143249002|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.00032|TWO_SIDED|95.0|-0.76|-0.23|||Mixed Models Analysis|Linear mixed model using treatment group as fixed effect, Baseline total RQLQ score as covariate and pooled geographical region as random effect||Average Total RQLQ Score During Peak GPS||-0.23|-0.76|0.00032
71866420|NCT05540717|143249003|SUPERIORITY||Mean Difference (Final Values)|3.99|||<|1e-05|TWO_SIDED|95.0|3.28|4.7|||Mixed Models Analysis|||Change from baseline to Visit 7 of serum grass-specific IgG4 \[mg/L\]||4.7|3.28|<0.00001
71866421|NCT05540717|143249004|SUPERIORITY||Odds Ratio (OR)|1.254||||0.10846|TWO_SIDED|95.0|0.951|1.652|||Regression, Logistic|The probability of a well day was calculated using a generalized estimating equation (GEE) or similar approaches as appropriate.||Probability of Well Days During Peak (truncated) GPS||1.652|0.951|0.10846
71866422|NCT01470001|143249039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.7||||0.1135|TWO_SIDED|95.0|-4.3|39.7|||Mixed Models Analysis|mixed model with repeated measurements||A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.||39.7|-4.3|.1135
71922269|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.57|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|95.0|1.19|9.95|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 12-16 hours||9.95|1.19|
71866423|NCT01470001|143249040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.3||||0.0919|TWO_SIDED|95.0|-2.3|30.8|||Regression, Logistic|logistic regression with repeated measurements||||30.8|-2.3|.0919
71866424|NCT01470001|143249041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7||||0.44|TWO_SIDED|95.0|-17.5|6.2||p value was adjusted for age.|ANCOVA||we calculated the estimated difference in change between the placebo and treatment groups.|the difference in change between the groups was measured||6.2|-17.5|0.44
71866425|NCT02236988|143249080|OTHER||Ratio of Adjusted Geometric Means|65.3|||||TWO_SIDED|90.0|55.0|77.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an analysis of variance (ANOVA) was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||77.6|55.0|
71866426|NCT02236988|143249080|OTHER||Ratio of Adjusted Geometric Means|80.4|||||TWO_SIDED|90.0|67.8|95.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||95.5|67.8|
71866427|NCT02236988|143249080|OTHER||Ratio of Adjusted Geometric Means|84.2|||||TWO_SIDED|90.0|70.9|99.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||99.9|70.9|
71866428|NCT02236988|143249082|OTHER||Ratio of Adjusted Geometric Means|61.8|||||TWO_SIDED|90.0|51.7|73.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||73.9|51.7|
71682698|NCT04108988|142883453|SUPERIORITY|||||||0.165|||||||t-test, 2 sided|||P value at baseline.||||0.165
71682699|NCT04108988|142883454|SUPERIORITY|||||||0.473|||||||t-test, 2 sided|||P value at month 4.||||0.473
71866429|NCT02236988|143249082|OTHER||Ratio of Adjusted Geometric Means|71.2|||||TWO_SIDED|90.0|59.6|85.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.1|59.6|
71866430|NCT02236988|143249082|OTHER||Ratio of Adjusted Geometric Means|73.8|||||TWO_SIDED|90.0|61.7|88.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.2|61.7|
71682700|NCT04108988|142883454|SUPERIORITY|||||||0.316|||||||t-test, 2 sided|||P value at month 1.||||0.316
71682701|NCT04108988|142883454|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||P value at baseline.||||0.345
71866431|NCT02236988|143249083|OTHER||Ratio of Adjusted Geometric Means|62.3|||||TWO_SIDED|90.0|52.1|74.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 1 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.4|52.1|
71866432|NCT02236988|143249083|OTHER||Ratio of Adjusted Geometric Means|71.3|||||TWO_SIDED|90.0|59.7|85.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 2 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.2|59.7|
71866433|NCT02236988|143249083|OTHER||Ratio of Adjusted Geometric Means|74.0|||||TWO_SIDED|90.0|62.0|88.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 3 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.4|62.0|
71866434|NCT02236988|143249084|OTHER||Median Difference|1.0||||0.009|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 1 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.5|0.0090
71866435|NCT02236988|143249084|OTHER||Median Difference|1.26||||0.0073|TWO_SIDED|90.0|0.5|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 2 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|0.50|0.0073
71866436|NCT02236988|143249084|OTHER||Median Difference|2.0|||<|0.0001|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 3 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|<0.0001
71682702|NCT04108988|142883455|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||P value at month 4.||||0.141
71866437|NCT02236988|143249090|OTHER||Ratio of Adjusted Geometric Means|90.9|||||TWO_SIDED|90.0|81.8|101.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||101.1|81.8|
71866438|NCT02236988|143249090|OTHER||Ratio of Adjusted Geometric Means|73.7|||||TWO_SIDED|90.0|66.3|82.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||82.0|66.3|
71866439|NCT02236988|143249090|OTHER||Ratio of Adjusted Geometric Means|80.2|||||TWO_SIDED|90.0|72.2|89.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.2|72.2|
71866440|NCT02236988|143249091|OTHER||Ratio of Adjusted Geometric Means|84.9|||||TWO_SIDED|90.0|77.5|93.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.0|77.5|
71866441|NCT02236988|143249091|OTHER||Ratio of Adjusted Geometric Means|72.0|||||TWO_SIDED|90.0|65.8|78.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||78.9|65.8|
71866442|NCT02236988|143249091|OTHER||Ratio of Adjusted Geometric Means|78.0|||||TWO_SIDED|90.0|71.2|85.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.5|71.2|
71866443|NCT02236988|143249092|OTHER||Ratio of Adjusted Geometric Means|85.5|||||TWO_SIDED|90.0|78.1|93.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 4 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||93.6|78.1|
71922270|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|3.63|STANDARD_ERROR_OF_MEAN|1.59|||TWO_SIDED|95.0|0.34|6.91|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||6.91|0.34|
71922271|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|2.41|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|95.0|-0.84|5.66|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 16-20 hours||5.66|-0.84|
71682703|NCT04108988|142883455|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||P value at month 1.||||0.314
71682704|NCT04108988|142883455|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||P value at baseline.||||0.444
71866444|NCT02236988|143249092|OTHER||Ratio of Adjusted Geometric Means|72.6|||||TWO_SIDED|90.0|66.3|79.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 5 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||79.5|66.3|
71866445|NCT02236988|143249092|OTHER||Ratio of Adjusted Geometric Means|78.9|||||TWO_SIDED|90.0|72.0|86.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 6 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.4|72.0|
71866446|NCT02236988|143249093|OTHER||Median Difference|2.0||||0.0002|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 4 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0002
71866447|NCT02236988|143249093|OTHER||Median Difference|1.02||||0.0049|TWO_SIDED|90.0|0.5|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 5 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|0.50|0.0049
71911405|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-5.44|||<|0.0001|TWO_SIDED|95.0|-7.11|-3.77||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.77|-7.11|<0.0001
71866448|NCT02236988|143249093|OTHER||Median Difference|1.5||||0.001|TWO_SIDED|90.0|1.0|2.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 6 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||2.00|1.00|0.0010
71866449|NCT02236988|143249099|OTHER||Ratio of Adjusted Geometric Means|91.0|||||TWO_SIDED|90.0|80.4|103.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||103.0|80.4|
71866450|NCT02236988|143249099|OTHER||Ratio of Adjusted Geometric Means|88.4|||||TWO_SIDED|90.0|78.1|100.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||100.0|78.1|
71866451|NCT02236988|143249100|OTHER||Ratio of Adjusted Geometric Means|80.6|||||TWO_SIDED|90.0|73.8|88.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.0|73.8|
71911406|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-7.05|||<|0.0001|TWO_SIDED|95.0|-8.79|-5.31||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-5.31|-8.79|<0.0001
71911407|NCT04153929|143343392|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.85|||<|0.0001|TWO_SIDED|95.0|-5.52|-2.18||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 2, 3, 4, 5, 6, 7, 8, 12, 16 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-2.18|-5.52|<0.0001
71911408|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-0.62||||0.7708|TWO_SIDED|95.0|-4.82|3.57||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||3.57|-4.82|0.7708
71866452|NCT02236988|143249100|OTHER||Ratio of Adjusted Geometric Means|78.5|||||TWO_SIDED|90.0|71.9|85.7|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||85.7|71.9|
71866453|NCT02236988|143249101|OTHER||Ratio of Adjusted Geometric Means|81.1|||||TWO_SIDED|90.0|74.3|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 8 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|74.3|
71866454|NCT02236988|143249101|OTHER||Ratio of Adjusted Geometric Means|79.0|||||TWO_SIDED|90.0|72.3|86.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 9 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||86.3|72.3|
71866455|NCT02236988|143249102|OTHER||Median Difference|0.98||||0.0374|TWO_SIDED|90.0|0.02|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 8 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.02|0.0374
71866456|NCT02236988|143249102|OTHER||Median Difference|0.51||||0.1907|TWO_SIDED|90.0|0.0|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 9 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.00|0.1907
71866457|NCT02236988|143249108|OTHER||Ratio of Adjusted Geometric Means|109.4|||||TWO_SIDED|90.0|98.6|121.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||121.3|98.6|
71866458|NCT02236988|143249108|OTHER||Ratio of Adjusted Geometric Means|107.2|||||TWO_SIDED|90.0|96.4|119.2|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||119.2|96.4|
71682705|NCT01642485|142883473|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The effect of insulin, C-peptide and glucose on QTcF was investigated using linear mixed effect concentration-response models with the double difference of QTcF (difference to time matched placebo of the change from average baseline) as dependent variable and up to two of the variables change from time matched placebo in insulin, C-peptide and glucose as covariates.||||0.05
71682706|NCT01642485|142883474|SUPERIORITY_OR_OTHER|||||||0.05|||||||t-test, 1 sided|||The relevant confirmatory null hypotheses could all be rejected on the 5% level (one sided), i.e. a difference in QTcF between continental breakfast and placebo; between FDA breakfast and placebo could be ascertained.||||0.05
71866459|NCT02236988|143249108|OTHER||Ratio of Adjusted Geometric Means|72.7|||||TWO_SIDED|90.0|65.5|80.8|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||80.8|65.5|
71866460|NCT02236988|143249108|OTHER||Ratio of Adjusted Geometric Means|103.5|||||TWO_SIDED|90.0|93.1|114.9|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed Cmax value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||114.9|93.1|
71866461|NCT02236988|143249109|OTHER||Ratio of Adjusted Geometric Means|81.5|||||TWO_SIDED|90.0|75.2|88.3|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.3|75.2|
71866462|NCT02236988|143249109|OTHER||Ratio of Adjusted Geometric Means|82.4|||||TWO_SIDED|90.0|75.9|89.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||89.5|75.9|
71866463|NCT02236988|143249109|OTHER||Ratio of Adjusted Geometric Means|68.2|||||TWO_SIDED|90.0|62.9|74.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.0|62.9|
71922272|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|1.74|STANDARD_ERROR_OF_MEAN|2.23|||TWO_SIDED|95.0|-2.89|6.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||6.36|-2.89|
71682707|NCT01642485|142883474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|||||TWO_SIDED|90.0|-10.4|-5.5||||||||-5.5|-10.4|
71682708|NCT01642485|142883474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-6.8|||||TWO_SIDED|90.0|-9.3|-4.3||||||||-4.3|-9.3|
71682709|NCT00766467|142883479|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3
71866464|NCT02236988|143249109|OTHER||Ratio of Adjusted Geometric Means|77.4|||||TWO_SIDED|90.0|71.3|84.0|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-t value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.0|71.3|
71866465|NCT02236988|143249110|OTHER||Ratio of Adjusted Geometric Means|81.9|||||TWO_SIDED|90.0|75.6|88.6|||||Ratio of adjusted geometric means (Apremilast Modified Release 11 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||88.6|75.6|
71866466|NCT02236988|143249110|OTHER||Ratio of Adjusted Geometric Means|83.0|||||TWO_SIDED|90.0|76.5|90.1|||||Ratio of adjusted geometric means (Apremilast Modified Release 12 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||90.1|76.5|
71866467|NCT02236988|143249110|OTHER||Ratio of Adjusted Geometric Means|68.8|||||TWO_SIDED|90.0|63.4|74.5|||||Ratio of adjusted geometric means (Apremilast Modified Release 13 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||74.5|63.4|
71866468|NCT02236988|143249110|OTHER||Ratio of Adjusted Geometric Means|77.8|||||TWO_SIDED|90.0|71.8|84.4|||||Ratio of adjusted geometric means (Apremilast Modified Release 14 / Apremilast Immediate Release) expressed as a percentage.|To compare each test formulation with the reference formulation in each group, an ANOVA was performed on the natural log-transformed AUC0-∞ value. The ANOVA model included treatment, sequence, and period as fixed effects and subject nested within sequence as a random effect.||84.4|71.8|
71866469|NCT02236988|143249111|OTHER||Median Difference|0.98||||0.0523|TWO_SIDED|90.0|0.03|1.5|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 11 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.50|0.03|0.0523
71866470|NCT02236988|143249111|OTHER||Median Difference|0.5||||0.2598|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 12 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.2598
71866471|NCT02236988|143249111|OTHER||Median Difference|1.5||||0.0053|TWO_SIDED|90.0|1.0|3.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 13 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||3.00|1.00|0.0053
71866472|NCT02236988|143249111|OTHER||Median Difference|0.5||||0.1093|TWO_SIDED|90.0|0.0|1.0|||Wilcoxon signed-rank test||Median difference (Apremilast Modified Release 14 - Apremilast Immediate Release) calculated from the Hodges-Lehmann estimate.|Tmax was analyzed by nonparametric methods. The median difference and 90% CI of the median difference were calculated from the Hodges-Lehrmann estimate.||1.00|0.00|0.1093
71911409|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.68||||0.7462|TWO_SIDED|95.0|-3.44|4.79||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||4.79|-3.44|0.7462
71866473|NCT04032613|143249120|OTHER|Paired sample t-test||||||0.2||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.20
71866474|NCT04032613|143249121|OTHER|Paired sample t-test||||||0.05||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.05
71866475|NCT04032613|143249122|OTHER|Paired sample t-test||||||0.004||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.004
71866476|NCT04032613|143249123|OTHER|Paired sample t-test||||||0.14||||||Statistically significant p-value is \<0.05|Paired sample t-test|||||||0.14
71911410|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-3.32||||0.1302|TWO_SIDED|95.0|-7.62|0.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||0.98|-7.62|0.1302
71911411|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-4.61||||0.0414|TWO_SIDED|95.0|-9.03|-0.18||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-0.18|-9.03|0.0414
71922273|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.25|||TWO_SIDED|95.0|-4.33|4.99|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 1, 20-24 hours||4.99|-4.33|
71682710|NCT00676572|142883483|SUPERIORITY||||||<|0.05||||||calculated p values|t-test, 2 sided|||||||<0.05
71866477|NCT01232738|143249136|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.07|TWO_SIDED|95.0|-0.53|0.02|||Chi-squared|||Difference in slope of decline||0.02|-0.53|0.07
71866478|NCT01232738|143249137|SUPERIORITY|||||||0.58|||||||Log Rank|||||||0.58
71866479|NCT03151993|143249158|NON_INFERIORITY|The non-inferiority hypothesis would be declared if the lower limit of the 95% CI for an mRS score of 0-1 on day 90 did not cross the margin of noninferiority of 16%. The non-inferiority hypothesis was tested using Welch's t-test for the primary outcome only.|Odds Ratio (OR)|9.5|||<|0.01|TWO_SIDED|95.0|-1.7|20.7|||Welch's t-test|||||20.7|-1.7|<0.01
71911412|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.55||||0.2273|TWO_SIDED|95.0|-6.71|1.6||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.2 twice weekly (2.4) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.60|-6.71|0.2273
71866480|NCT04155047|143249165|SUPERIORITY||Least Squares Mean Difference|-0.323|STANDARD_ERROR_OF_MEAN|0.1861||0.0987|TWO_SIDED|95.0|-0.711|0.066|||Mixed Models Analysis|||||0.066|-0.711|0.0987
71911413|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-8.4||||0.0002|TWO_SIDED|95.0|-12.81|-3.98||P-value is considered nominal.|Mixed Model for Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as BI 456906 1.8 twice weekly (3.6) mg - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||-3.98|-12.81|0.0002
71911414|NCT04153929|143343393|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-2.72||||0.1967|TWO_SIDED|95.0|-6.86|1.42||P-value is considered nominal.|Mixed Model Repeated Measures (MMRM)|Kenward-Roger was used to estimate denominator degrees of freedom.|"Difference was calculated as Semaglutide - Placebo at Week 17."|Mixed Model Repeated Measures (MMRM) with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (Week 6 and 17 ) as repeated measures, subject as random effect, unstructured covariance matrix to model within subject measurements.||1.42|-6.86|0.1967
71911415|NCT04153929|143343394|OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.28|5.2|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||5.20|0.28|
71911416|NCT04153929|143343394|OTHER||Odds Ratio (OR)|7.92|||||TWO_SIDED|95.0|2.43|25.74|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||25.74|2.43|
71911417|NCT04153929|143343394|OTHER||Odds Ratio (OR)|17.68|||||TWO_SIDED|95.0|5.21|60.03|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||60.03|5.21|
71911418|NCT04153929|143343394|OTHER||Odds Ratio (OR)|25.87|||||TWO_SIDED|95.0|7.31|91.55|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||91.55|7.31|
71911419|NCT04153929|143343394|OTHER||Odds Ratio (OR)|21.75|||||TWO_SIDED|95.0|6.57|72.04|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||72.04|6.57|
71911420|NCT04153929|143343394|OTHER||Odds Ratio (OR)|35.0|||||TWO_SIDED|95.0|9.84|124.47|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||124.47|9.84|
71911421|NCT04153929|143343394|OTHER||Odds Ratio (OR)|8.22|||||TWO_SIDED|95.0|2.52|26.79|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model for body weight loss with treatment as fixed effect.||26.79|2.52|
71911422|NCT04153929|143343395|OTHER||Odds Ratio (OR)|3.67|||||TWO_SIDED|95.0|0.14|95.73|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||95.73|0.14|
71682711|NCT00334802|142883551|SUPERIORITY_OR_OTHER|||||||0.169||95.0||||P-value for Dose Level 1 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.169
71866481|NCT03361605|143249171|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli."|Mean Difference (Net)|-0.349|STANDARD_DEVIATION|0.223|<|0.0001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline.||||<0.0001
71911423|NCT04153929|143343395|OTHER||Odds Ratio (OR)|7.97|||||TWO_SIDED|95.0|0.39|163.56|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||163.56|0.39|
71911424|NCT04153929|143343395|OTHER||Odds Ratio (OR)|25.17|||||TWO_SIDED|95.0|1.35|471.09|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||471.09|1.35|
71911425|NCT04153929|143343395|OTHER||Odds Ratio (OR)|33.01|||||TWO_SIDED|95.0|1.78|613.51||||||Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||613.51|1.78|
71911426|NCT04153929|143343395|OTHER||Odds Ratio (OR)|42.44|||||TWO_SIDED|95.0|2.37|761.44|||||Odds Ratio was calculated as BI 456906 / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||761.44|2.37|
71911427|NCT04153929|143343395|OTHER||Odds Ratio (OR)|84.53|||||TWO_SIDED|95.0|4.71|999.0|||||Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||999|4.71|
71866482|NCT03361605|143249172|SUPERIORITY|"Our study adopted a within-subject design, which is not a randomized controlled trial (RCT) such as testing if one treatment is superior to another. Therefore, here the Superiority indicates if propofol administration has a statistically significant impact on the squeeze pressure in response to verbal instructions."|Mean Difference (Net)|-2.16|STANDARD_DEVIATION|3.09||0.00148|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|The null hypothesis is no difference in squeeze pressure between sedated state and baseline.||||0.00148
71866483|NCT02770612|143249175|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on discharge||||<0.001
71866484|NCT02369068|143249184|OTHER|||||||0.072|||||||Kruskal-Wallis|This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.||The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.||||0.072
71866485|NCT02369068|143249185|OTHER|||||||0.624|||||||Kruskal-Wallis|||The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05||||0.624
71866486|NCT02369068|143249186|OTHER|||||||0.571|||||||Kruskal-Wallis|||The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05||||0.571
71866487|NCT02369068|143249187|OTHER|||||||0.285|||||||Kruskal-Wallis|||The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05||||0.285
71866488|NCT01989169|143249316|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.215|||||TWO_SIDED|90.0|1.116|1.323|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.323|1.116|
71866489|NCT01989169|143249317|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.216|||||TWO_SIDED|90.0|1.115|1.327|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.327|1.115|
71866490|NCT01989169|143249318|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.383|||||TWO_SIDED|90.0|1.282|1.491|||Mixed-effects Model||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.||1.491|1.282|
71911428|NCT04153929|143343395|OTHER||Odds Ratio (OR)|22.44|||||TWO_SIDED|95.0|1.22|413.33|||||Odds Ratio was calculated as Semaglutide / Placebo.|Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.||413.33|1.22|
71866491|NCT02406677|143249319|SUPERIORITY||Hazard Ratio (HR)|1.073||||0.3503|TWO_SIDED|95.0|0.925|1.246|||Regression, Cox|Cox proportional hazards model accounting for within hospital clustering using robust standard errors|Usual Care arm is the reference group|||1.246|0.925|0.3503
71866492|NCT02406677|143249320|SUPERIORITY||Odds Ratio (OR)|0.838||||0.026|TWO_SIDED|95.0|0.717|0.979|||Regression, Logistic|Logistic regression model with parameters estimated using GEE to account for within hospital clustering for selected patient characteristics||||0.979|0.717|0.0260
71866493|NCT02406677|143249321|SUPERIORITY||Odds Ratio (OR)|2.035|||<|0.0001|TWO_SIDED|95.0|1.564|2.649|||Regression, Logistic|Logistic regression with GEE to account for within hospital clustering||||2.649|1.564|<0.0001
71866494|NCT05384938|143249354|OTHER|Single group|Median time to response|100.0|||||TWO_SIDED|95.0|65.0|160.0|||||Estimate for Time to Response using Kaplan-Meier method|Estimate for Time to Response (Days)||160.0|65.00|
71866495|NCT05384938|143249358|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 4 (Visit 2)||||<0.0001
71866496|NCT05384938|143249358|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 16 (Visit 4)||||<0.0001
71911429|NCT01963780|143343396|SUPERIORITY|Performance goal is 65%.|Proportion|0.544||||0.9663|TWO_SIDED|95.0|0.428|0.657|||one-sided exact binomial test|||||0.657|0.428|0.9663
71911430|NCT01963780|143343397|OTHER|No statistical hypothesis testing|Proportion|0.167|||||TWO_SIDED|95.0|0.092|0.268||||||||0.268|0.092|
71911431|NCT01963780|143343398|OTHER|No statistical hypothesis testing|Proportion|0.064|||||TWO_SIDED|95.0|0.021|0.143||||||||0.143|0.021|
71911432|NCT01963780|143343399|OTHER|No statistical hypothesis testing|Mean|0.3|||||TWO_SIDED|95.0|0.1|0.4||||||||0.4|0.1|
71911433|NCT02971293|143343463|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71866497|NCT05384938|143249358|OTHER|Parametric Test|||||<|0.0001|||||||paired t-test|||Week 24 (Visit 5)||||<0.0001
71682712|NCT00334802|142883551|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Dose Level 2 Responders (Complete Response + Partial Response)|t-test, 2 sided|||||||0.001
71682713|NCT00926536|142883619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|71.6|||<|0.001|TWO_SIDED|||||Decrease in DAP in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||<.001
71866498|NCT00128102|143249419|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.858|TWO_SIDED|95.0|0.83|1.17|||Log Rank|||||1.17|0.83|0.858
71866499|NCT00128102|143249423|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.63|0.88|||Likelihood Based Score Test|||||0.88|0.63|<0.001
71866500|NCT00128102|143249424|SUPERIORITY||Difference in Percentage|0.3||||0.621|TWO_SIDED|95.0|-1.18|1.97|||Fisher Exact|||||1.97|-1.18|0.621
71866501|NCT00128102|143249425|SUPERIORITY||Difference in Percent Change|-52.4||||0.259|TWO_SIDED|95.0|-143.5|38.6|||Longitudinal Model|||||38.6|-143.5|0.259
71866502|NCT00128102|143249426|SUPERIORITY||Difference in Percentage|-1.3||||0.736|TWO_SIDED|95.0|-7.2|4.53|||Fisher Exact|||||4.53|-7.20|0.736
71866503|NCT00128102|143249427|SUPERIORITY||Difference in Percent Change|-0.06||||0.979|TWO_SIDED|95.0|-4.61|4.49|||Longitudinal Model|||||4.49|-4.61|0.979
71866504|NCT00128102|143249428|SUPERIORITY||Difference in Percentage|3.1||||0.488|TWO_SIDED|95.0|-4.97|11.17|||Fisher Exact|||||11.17|-4.97|0.488
71866505|NCT04143945|143249444|OTHER|Comparison|Estimated treatment difference|2.6||||0.0395|TWO_SIDED|95.0|0.1|5.1|||ANOVA|||The intensity of pain was analysed by a fixed analysis of variance model with VAS pain score as the dependent variable, and product, injection side (right side, left side), injection number (first injection, second injection), and participant as fixed effects.||5.1|0.1|0.0395
71866506|NCT00503139|143249463|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
71866507|NCT00503139|143249464|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.||||<0.001
71866508|NCT02731690|143249473|SUPERIORITY|||||||0.5303||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5303
71866509|NCT02731690|143249473|SUPERIORITY|||||||0.1646||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1646
71866510|NCT02731690|143249473|SUPERIORITY|||||||0.1189||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1189
71866511|NCT02731690|143249473|SUPERIORITY|||||||0.0706||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0706
71866512|NCT02731690|143249474|SUPERIORITY|||||||0.0715||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0715
71866513|NCT02731690|143249474|SUPERIORITY|||||||0.1697||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.1697
71682714|NCT00926536|142883620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|158.3||||0.017|TWO_SIDED|||||Decrease in CD in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis|||||||0.017
71866514|NCT02731690|143249474|SUPERIORITY|||||||0.3428||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.3428
71866515|NCT02731690|143249474|SUPERIORITY|||||||0.0642||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0642
71866516|NCT02731690|143249475|SUPERIORITY|||||||0.0568||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0568
71866517|NCT02731690|143249475|SUPERIORITY|||||||0.0533||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0533
71866518|NCT02731690|143249475|SUPERIORITY|||||||0.0459||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0459
71911434|NCT02971293|143343463|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911435|NCT02971293|143343463|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
71911436|NCT02971293|143343475|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.002
71911437|NCT02971293|143343475|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71866519|NCT02731690|143249475|SUPERIORITY|||||||0.5678||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.5678
71866520|NCT02731690|143249476|SUPERIORITY|||||||0.581||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.5810
71866521|NCT02731690|143249476|SUPERIORITY|||||||0.0465||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0465
71866522|NCT02731690|143249476|SUPERIORITY|||||||0.1047||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.1047
71911438|NCT02971293|143343475|SUPERIORITY|||||||0.011|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.011
71911439|NCT02971293|143343476|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71911440|NCT02971293|143343476|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911441|NCT02971293|143343476|SUPERIORITY|||||||0.201|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.201
71911442|NCT02971293|143343477|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71866523|NCT02731690|143249476|SUPERIORITY|||||||0.0661||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0661
71866524|NCT02731690|143249477|SUPERIORITY|||||||0.1615||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.1615
71866525|NCT02731690|143249477|SUPERIORITY|||||||0.6201||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6201
71866526|NCT02731690|143249477|SUPERIORITY|||||||0.9229||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.9229
71911443|NCT02971293|143343477|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911444|NCT02971293|143343477|SUPERIORITY|||||||0.02|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.020
71911445|NCT02971293|143343478|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71911446|NCT02971293|143343478|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911447|NCT02971293|143343478|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
71911448|NCT02971293|143343479|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71911449|NCT02971293|143343479|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911450|NCT02971293|143343479|SUPERIORITY|||||||0.092|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.092
71911451|NCT02971293|143343480|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71911452|NCT02971293|143343480|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911453|NCT02971293|143343480|SUPERIORITY|||||||0.279|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.279
71911454|NCT02971293|143343481|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo||||<0.001
71866527|NCT02731690|143249477|SUPERIORITY|||||||0.6307||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.6307
71866528|NCT02731690|143249478|SUPERIORITY|||||||0.0088||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0088
71866529|NCT02731690|143249478|SUPERIORITY|||||||0.2213||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.2213
71866530|NCT02731690|143249478|SUPERIORITY|||||||0.018||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0180
71866531|NCT02731690|143249478|SUPERIORITY|||||||0.197||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.1970
71866532|NCT02731690|143249479|SUPERIORITY|||||||0.0752||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0752
71866533|NCT02731690|143249479|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.6403||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.6403
71866534|NCT02731690|143249479|SUPERIORITY|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.2316||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.2316
71866535|NCT02731690|143249479|SUPERIORITY|||||||0.7635||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.7635
71866536|NCT02731690|143249480|SUPERIORITY|||||||0.0872||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12||||0.0872
71866537|NCT02731690|143249480|SUPERIORITY|||||||0.0073||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24||||0.0073
71911455|NCT02971293|143343481|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911456|NCT02971293|143343481|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment\*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||<0.001
71911457|NCT02971293|143343482|SUPERIORITY|||||||0.205|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.205
71911458|NCT02971293|143343482|SUPERIORITY|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.002
71911459|NCT02971293|143343482|SUPERIORITY|||||||0.06|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.060
71911460|NCT02971293|143343483|SUPERIORITY|||||||0.111|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.111
71911461|NCT02971293|143343483|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911462|NCT02971293|143343483|SUPERIORITY|||||||0.015|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.015
71911463|NCT02971293|143343484|SUPERIORITY|||||||0.621|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.621
71911464|NCT02971293|143343484|SUPERIORITY|||||||0.138|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.138
71911465|NCT02971293|143343484|SUPERIORITY|||||||0.333|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.333
71911466|NCT02971293|143343485|SUPERIORITY|||||||0.748|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.748
71911467|NCT02971293|143343485|SUPERIORITY|||||||0.005|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.005
71911468|NCT02971293|143343485|SUPERIORITY|||||||0.013|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.013
71866538|NCT02731690|143249480|SUPERIORITY|||||||0.0086||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36||||0.0086
71866539|NCT02731690|143249480|SUPERIORITY|||||||0.0489||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48||||0.0489
71866540|NCT00833833|143249483|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.73|||||TWO_SIDED|95.0|0.54|0.99||||||With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.||0.99|0.54|
71866541|NCT00833833|143249488|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|6.25|||||TWO_SIDED|95.0|0.84|46.66||||||||46.66|0.84|
71682715|NCT01080391|142883624|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.57|0.834||Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)|Log Rank|The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).||||0.834|0.570|< 0.0001
71866542|NCT00833833|143249489|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.070
71866543|NCT00833833|143249490|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.57|1.29||||||||1.29|0.57|
71866544|NCT01262677|143249524|SUPERIORITY||Mean Difference|-0.99||||0.9076|TWO_SIDED|95.0|-16.28|17.11||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||17.11|-16.28|0.9076
71866545|NCT01262677|143249524|SUPERIORITY||Mean Difference|-13.05||||0.0907|TWO_SIDED|95.0|-26.07|2.25||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.||2.25|-26.07|0.0907
71866546|NCT01262677|143249525|SUPERIORITY|||||||0.752||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.752
71866547|NCT01262677|143249525|SUPERIORITY|||||||0.125||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.||||0.125
71911469|NCT02971293|143343486|SUPERIORITY|||||||0.064|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.064
71866548|NCT01262677|143249526|SUPERIORITY||LS Mean Difference|-9.3||||0.5404|TWO_SIDED|95.0|-39.16|20.56||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||20.56|-39.16|0.5404
71866549|NCT01262677|143249526|SUPERIORITY||LS Mean Difference|-25.84||||0.0786|TWO_SIDED|95.0|-54.64|2.97||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.||2.97|-54.64|0.0786
71911470|NCT02971293|143343486|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911471|NCT02971293|143343486|SUPERIORITY|||||||0.03|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.030
71911472|NCT02971293|143343487|SUPERIORITY|||||||0.018|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.018
71911473|NCT02971293|143343487|SUPERIORITY||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||<0.001
71911474|NCT02971293|143343487|SUPERIORITY|||||||0.047|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.047
71911475|NCT02971293|143343488|SUPERIORITY|||||||0.477|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.477
71911476|NCT02971293|143343488|SUPERIORITY|||||||0.014|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.014
71911477|NCT02971293|143343488|SUPERIORITY|||||||0.084|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.084
71911478|NCT02971293|143343489|SUPERIORITY|||||||0.213|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo||||0.213
71911479|NCT02971293|143343489|SUPERIORITY|||||||0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo||||0.001
71911480|NCT02971293|143343489|SUPERIORITY|||||||0.046|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg||||0.046
71911481|NCT00729326|143343490|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.|ANCOVA|Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.||Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.||||<.001
71911482|NCT00729326|143343491|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911483|NCT00729326|143343492|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||ANCOVA|||||||.766
71911484|NCT00729326|143343493|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911485|NCT00729326|143343494|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911486|NCT00729326|143343495|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||ANCOVA|||||||.117
71911487|NCT00729326|143343496|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911488|NCT00729326|143343497|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911489|NCT00729326|143343498|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911490|NCT00729326|143343499|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911491|NCT00729326|143343500|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911492|NCT00729326|143343501|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911493|NCT00729326|143343502|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<.001
71911494|NCT03418051|143343519|SUPERIORITY|||||||0.824||||||A priori alpha level was set to 0.05|ANOVA|||||||0.824
71911495|NCT03418051|143343519|SUPERIORITY|||||||0.426||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.426
71911496|NCT03418051|143343520|SUPERIORITY|||||||0.722||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.722
71866550|NCT01262677|143249527|SUPERIORITY||LS Mean Difference|-0.11||||0.6073|TWO_SIDED|95.0|-0.53|0.31||Statistical testing was done at alpha = 0.05 level, two-sided.|Generalized linear model (GLM)|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.31|-0.53|0.6073
71866551|NCT01262677|143249527|SUPERIORITY||LS Mean Difference|-0.16||||0.4109|TWO_SIDED|95.0|-0.53|0.22||Statistical testing was done at alpha = 0.05 level, two-sided.|GLM|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.||0.22|-0.53|0.4109
71866552|NCT01262677|143249528|SUPERIORITY||LS Mean Difference|-1.38||||0.8268|TWO_SIDED|95.0|-12.97|11.75||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||11.75|-12.97|0.8268
71866553|NCT01262677|143249528|SUPERIORITY||LS Mean Difference|0.75||||0.9024|TWO_SIDED|95.0|-10.69|13.66||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||13.66|-10.69|0.9024
71866554|NCT01262677|143249529|SUPERIORITY|||||||0.67||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.670
71866555|NCT01262677|143249529|SUPERIORITY|||||||0.927||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.||||0.927
71866556|NCT01262677|143249530|SUPERIORITY||LS Mean Difference|2.28||||0.8034|TWO_SIDED|95.0|-14.37|22.15||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||22.15|-14.37|0.8034
71866557|NCT01262677|143249530|SUPERIORITY||LS Mean Difference|-10.78||||0.1905|TWO_SIDED|95.0|-24.81|5.87||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.87|-24.81|0.1905
71866558|NCT01262677|143249531|SUPERIORITY||LS Mean Difference|-0.3||||0.465|TWO_SIDED|95.0|-1.1|0.5||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.5|-1.1|0.4650
71866559|NCT01262677|143249531|SUPERIORITY||LS Mean Difference|0.0||||0.9692|TWO_SIDED|95.0|-0.8|0.8||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.8|-0.8|0.9692
71911497|NCT03418051|143343520|SUPERIORITY|||||||0.843||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.843
71866560|NCT01262677|143249532|SUPERIORITY||LS Mean Difference|-0.5||||0.2693|TWO_SIDED|95.0|-1.3|0.4||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.4|-1.3|0.2693
71866561|NCT01262677|143249532|SUPERIORITY||LS Mean Difference|-0.5||||0.1893|TWO_SIDED|95.0|-1.4|0.3||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.||0.3|-1.4|0.1893
71866562|NCT01262677|143249533|SUPERIORITY||LS Mean Difference|-0.8||||0.7347|TWO_SIDED|95.0|-5.2|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-5.2|0.7347
71911498|NCT03418051|143343521|SUPERIORITY|||||||0.046||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.046
71911499|NCT03418051|143343521|SUPERIORITY|||||||0.845||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.845
71911500|NCT03418051|143343522|SUPERIORITY|||||||0.138||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.138
71911501|NCT03418051|143343522|SUPERIORITY|||||||0.523||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.523
71866563|NCT01262677|143249533|SUPERIORITY||LS Mean Difference|0.3||||0.8971|TWO_SIDED|95.0|-4.0|4.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.6|-4.0|0.8971
71866564|NCT01262677|143249534|SUPERIORITY||LS Mean Difference|-2.7||||0.3972|TWO_SIDED|95.0|-9.1|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.6|-9.1|0.3972
71866565|NCT01262677|143249534|SUPERIORITY||LS Mean Difference|6.7||||0.0319|TWO_SIDED|95.0|0.6|12.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||12.9|0.6|0.0319
71866566|NCT01262677|143249535|SUPERIORITY||LS Mean Difference|0.8||||0.7708|TWO_SIDED|95.0|-4.4|5.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.9|-4.4|0.7708
71866567|NCT01262677|143249535|SUPERIORITY||LS Mean Difference|2.4||||0.356|TWO_SIDED|95.0|-2.7|7.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||7.4|-2.7|0.3560
71866568|NCT01262677|143249536|SUPERIORITY||LS Mean Difference|0.2||||0.1129|TWO_SIDED|95.0|-0.1|0.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.5|-0.1|0.1129
71866569|NCT01262677|143249536|SUPERIORITY||LS Mean Difference|0.0||||0.9388|TWO_SIDED|95.0|-0.3|0.3||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||0.3|-0.3|0.9388
71682716|NCT01080391|142883625|SUPERIORITY|The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).|Hazard Ratio (HR)|0.794||||0.0045|TWO_SIDED|95.0|0.667|0.945|||Log Rank|Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).||The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).||0.945|0.667|0.0045
71866570|NCT01262677|143249537|SUPERIORITY||LS Mean Difference|-0.4||||0.9053|TWO_SIDED|95.0|-7.5|6.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||6.6|-7.5|0.9053
71911502|NCT03418051|143343523|SUPERIORITY|||||||0.069||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.069
71866571|NCT01262677|143249537|SUPERIORITY||LS Mean Difference|-1.6||||0.6371|TWO_SIDED|95.0|-8.5|5.2||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||5.2|-8.5|0.6371
71866572|NCT01262677|143249538|SUPERIORITY||LS Mean Difference|-6.4||||0.0119|TWO_SIDED|95.0|-11.4|-1.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||-1.4|-11.4|0.0119
71866573|NCT01262677|143249538|SUPERIORITY||LS Mean Difference|0.0||||0.9909|TWO_SIDED|95.0|-4.9|4.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.8|-4.9|0.9909
71911503|NCT03418051|143343523|SUPERIORITY|||||||0.413||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.413
71911504|NCT03418051|143343524|SUPERIORITY|||||||0.604||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.604
71911505|NCT03418051|143343524|SUPERIORITY|||||||0.499||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.499
71911506|NCT03418051|143343525|SUPERIORITY|||||||0.005||||||A priori threshold was set at 0.05.|ANOVA|||||||0.005
71911507|NCT03418051|143343525|SUPERIORITY|||||||0.853||||||A priori threshold set at 0.05.|ANOVA|||||||0.853
71911508|NCT03418051|143343526|SUPERIORITY|||||||0.142||||||A priori threshold set to 0.05|ANOVA|||||||0.142
71911509|NCT03418051|143343526|SUPERIORITY|||||||0.167||||||A priori threshold set at 0.05.|ANOVA|||||||0.167
71866574|NCT01262677|143249539|SUPERIORITY||LS Mean Difference|-1.1||||0.5903|TWO_SIDED|95.0|-5.0|2.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||2.8|-5.0|0.5903
71866575|NCT01262677|143249539|SUPERIORITY||LS Mean Difference|0.7||||0.7126|TWO_SIDED|95.0|-3.1|4.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||4.5|-3.1|0.7126
71866576|NCT01262677|143249540|SUPERIORITY||LS Mean Difference|-2.1||||0.2431|TWO_SIDED|95.0|-5.8|1.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||1.5|-5.8|0.2431
71866577|NCT01262677|143249540|SUPERIORITY||LS Mean Difference|0.3||||0.8654|TWO_SIDED|95.0|-3.2|3.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).||3.8|-3.2|0.8654
71866578|NCT01262677|143249541|SUPERIORITY||Odds Ratio (OR)|1.36||||0.3241|TWO_SIDED|95.0|0.74|2.5||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||2.50|0.74|0.3241
71682717|NCT01080391|142883626|SUPERIORITY||Odds Ratio (OR)|3.472|||<|0.0001|TWO_SIDED|95.0|2.411|5.001|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||5.001|2.411|< 0.0001
71911510|NCT03418051|143343527|SUPERIORITY|||||||0.849||||||A priori alpha set at 0.05.|ANOVA|||||||0.849
71911511|NCT03418051|143343527|SUPERIORITY|||||||0.993||||||A priori threshold set at 0.05.|ANOVA|||||||0.993
71911512|NCT03418051|143343528|SUPERIORITY|||||||0.535||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.535
71682718|NCT01080391|142883627|SUPERIORITY||Odds Ratio (OR)|1.897||||0.0044|TWO_SIDED|95.0|1.17|3.08|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.|||3.08|1.17|0.0044
71682719|NCT00672841|142883631|SUPERIORITY_OR_OTHER||Sensitivity|100.0||||||95.0|||||Sensitivity %||Sensitivity \[1\] = (True positives \[n=6\]/ True positives + False negatives \[n=6\])|Clinical sensitivity of the BDG test was calculated for both study groups combined||||
71866579|NCT01262677|143249541|SUPERIORITY||Odds Ratio (OR)|0.96||||0.8932|TWO_SIDED|95.0|0.54|1.71||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.||1.71|0.54|0.8932
71866580|NCT02055781|143249564|SUPERIORITY|||||||0.0011|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0011
71866581|NCT02055781|143249564|SUPERIORITY|||||||0.0173|||||||Fisher Exact|||||||0.0173
71866582|NCT02055781|143249564|SUPERIORITY|||||||0.0007|||||||Fisher Exact|||||||0.0007
71866583|NCT02055781|143249565|SUPERIORITY|||||||0.0791|||||||Fisher Exact|||BAT arm compared to pooled pacritinib arms (QD + BID - ITT Efficacy)||||0.0791
71866584|NCT02055781|143249565|SUPERIORITY|||||||0.6524|||||||Fisher Exact|||||||0.6524
71866585|NCT02055781|143249565|SUPERIORITY|||||||0.0106|||||||Fisher Exact|||||||0.0106
71866586|NCT00734591|143249602|SUPERIORITY_OR_OTHER||Exact method|2.81|||||TWO_SIDED|95.0|0.5|28.46|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||28.46|0.50|
71911513|NCT03418051|143343528|SUPERIORITY|||||||0.569||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.569
71911514|NCT03418051|143343529|SUPERIORITY|||||||0.405||||||A priori threshold was 0.05.|ANOVA|||||||0.405
71911515|NCT03418051|143343529|SUPERIORITY|||||||0.229||||||A priori threshold set to 0.05.|ANOVA|||||||0.229
71911516|NCT03418051|143343530|SUPERIORITY|||||||0.609||||||A priori threshold set at 0.05.|ANOVA|||||||0.609
71911517|NCT03418051|143343530|SUPERIORITY|||||||0.027||||||A priori threshold was set at 0.05.|ANOVA|||||||0.027
71911518|NCT03418051|143343531|SUPERIORITY|||||||0.613||||||A priori alpha set at 0.05.|Independent sample Mann-Whitney U|||||||0.613
71911519|NCT03418051|143343532|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Independent sample Mann-Whitney U|||||||0.925
71911520|NCT03418051|143343533|SUPERIORITY|||||||0.641||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.641
71911521|NCT03418051|143343533|SUPERIORITY|||||||0.897||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.897
71911522|NCT03418051|143343534|SUPERIORITY|||||||0.561||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.561
71911523|NCT03418051|143343534|SUPERIORITY|||||||0.925||||||A priori threshold set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.925
71911524|NCT03418051|143343535|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05|ANOVA|||||||0.233
71911525|NCT03418051|143343535|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05|ANOVA|||||||0.634
71911526|NCT03418051|143343536|SUPERIORITY|||||||0.233||||||A priori threshold set at 0.05.|ANOVA|||||||0.233
71866587|NCT00734591|143249603|SUPERIORITY_OR_OTHER||Exact method|2.29|||||TWO_SIDED|95.0|0.37|24.01|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||24.01|0.37|
71866588|NCT00734591|143249604|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.81|||||TWO_SIDED|95.0|0.6|1.1||||||||1.10|0.60|
71866589|NCT00734591|143249605|SUPERIORITY_OR_OTHER||Exact method|3.75|||||TWO_SIDED|95.0|1.01|20.68|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.|||20.68|1.01|
71866590|NCT01072630|143249613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.1302|TWO_SIDED|95.0|-4.67|0.6||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.60|-4.67|0.1302
71866591|NCT01072630|143249613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.135|TWO_SIDED|95.0|-4.51|0.61||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.||||0.61|-4.51|0.1350
71866592|NCT00338962|143249637|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.|Mixed Models Analysis|F=49.633||||||0.00
71866593|NCT00338962|143249639|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||ANOVA|||Gastrointestinal symptoms compared||||0.007
71682720|NCT00672841|142883631|SUPERIORITY_OR_OTHER||Specificity|50.0||||||95.0|||||% Specificity||Specificity \[0.50\]= True negatives \[n=28\]/ True negatives + False positives \[56\])|Clinical specificity of the BDG test was calculated for the study groups combined||||
71866594|NCT03547739|143249657|SUPERIORITY||Risk Ratio (RR)|4.22|||<|0.001|TWO_SIDED|95.0|2.88|6.18|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|Home visits as compared to Standard Care||6.18|2.88|<0.001
71682721|NCT00672841|142883633|SUPERIORITY_OR_OTHER||Percent Sensitivity|100.0||||||95.0|||||Sensitivity||Sensitivity = (true positives \[n=6\]/true positives + false negative \[n=6\])|The clinic sensitivity of the BDG test was calculated for both study groups combined||||
71866595|NCT03547739|143249657|SUPERIORITY||Risk Ratio (RR)|3.69|||<|0.001|TWO_SIDED|95.0|2.5|5.45|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and couple age disparity.|HIV Self-testing as compared to Standard Care||5.45|2.50|<0.001
71866596|NCT03547739|143249658|SUPERIORITY||Risk Ratio (RR)|1.21||||0.001|TWO_SIDED|95.0|1.12|1.31|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.31|1.12|.001
71866597|NCT03547739|143249658|SUPERIORITY||Risk Ratio (RR)|1.26||||0.001|TWO_SIDED|95.0|1.17|1.36|||Chi-squared||Generalized Estimating Equation model with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth index, length of couple relationship, previous couple testing at baseline, and and couple age disparity.|Comparison of HIVST arm with Standard Care arm||1.36|1.17|.001
71866598|NCT03547739|143249672|SUPERIORITY||Risk Ratio (RR)|1.08||||0.011|TWO_SIDED|95.0|1.03|1.12|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the Home Visit arm with Standard Care||1.12|1.03|.011
71866599|NCT03547739|143249672|SUPERIORITY||Risk Ratio (RR)|1.02||||0.011|TWO_SIDED|95.0|0.97|1.08|||Chi-squared||Generalized Estimating Equation model (binomial family and log link) with robust standard errors used. Risk Ratios reported were adjusted for baseline education level, wealth, length of couple relationship, and couple age disparity.|Comparison of the HIVST arm with Standard Care||1.08|0.97|0.011
71866600|NCT03547739|143249673|OTHER||Kaplan Meier estimates|0.92||||0.087|TWO_SIDED|95.0|0.86|0.95|||Log Rank|||||0.95|0.86|0.087
71866601|NCT03547739|143249673|OTHER||Kaplan Meier estimates|0.96||||0.087|TWO_SIDED|95.0|0.91|0.98|||Log Rank|||||0.98|0.91|0.087
71866602|NCT03547739|143249673|OTHER||Kaplan Meier estimates|0.98||||0.087|TWO_SIDED|95.0|0.93|0.99|||Log Rank|||||0.99|0.93|0.087
71866603|NCT02003222|143249728|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.003|TWO_SIDED|95.0|0.25|0.76|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||0.76|0.25|0.003
71866604|NCT02003222|143249729|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015|TWO_SIDED|95.0|0.31|0.89|||Log Rank||hazard ratio: Blinatumomab + Chemotherapy vs. Chemotherapy alone|||0.89|0.31|0.015
71866605|NCT02003222|143249730|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.67|TWO_SIDED|95.0|0.22|2.65|||Log Rank|||||2.65|0.22|0.67
71682722|NCT00672841|142883633|SUPERIORITY_OR_OTHER||Percent Specificity|52.0||||||95.0|||||Specificity||Specificity \[0.52\]= (True negatives \[n=30\]/True negatives + false positives \[n=58\])|The clinical specificity of the BDG test was calculated for both study groups combined||||
71866606|NCT02003222|143249731|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.28|3.63|||Log Rank|||||3.63|0.28|1.00
71866607|NCT02003222|143249732|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.41|TWO_SIDED|95.0|0.17|2.11|||Log Rank||hazard ratio: blinatumomab + chemotherapy vs. chemotherapy alone|||2.11|0.17|0.41
71866608|NCT02310100|143249748|OTHER|This is a one-group comparison to a performance goal.|binomial proportion|0.673||||0.0008|ONE_SIDED|95.0|0.608||||Exact binomial|||H0: PE ≤ 54.9% Ha: PE \> 54.9% Where PE is the primary effectiveness endpoint rate.|||0.608|0.0008
71866609|NCT02310100|143249749|OTHER|One group comparison to a performance goal.|binomial proportion|0.081||||0.0013|ONE_SIDED|95.0||0.124|||Exact binomial|||H0: PS ≥ 16.2% Ha: PS \< 16.2% where PS is the primary safety endpoint rate||0.124||0.0013
71911527|NCT03418051|143343536|SUPERIORITY|||||||0.634||||||A priori threshold set at 0.05.|ANOVA|||||||0.634
71911528|NCT03418051|143343537|SUPERIORITY|||||||0.03||||||A priori threshold set at 0.05.|ANOVA|||||||0.030
71911529|NCT03418051|143343537|SUPERIORITY|||||||0.618||||||A priori threshold set at 0.05.|ANOVA|||||||0.618
71911530|NCT03418051|143343538|SUPERIORITY|||||||0.456||||||A priori threshold set at 0.05.|ANOVA|||||||0.456
71866610|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 4||3.3|-6.8|
71866611|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 6B||4.3|-4.6|
71682723|NCT03578146|142883635|SUPERIORITY||Least Squares Means (Difference)|-73.14||||0.0121|TWO_SIDED||||||ANCOVA|||||||0.0121
71682724|NCT03578146|142883635|SUPERIORITY||Least Squares Means (Difference)|-153.99|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71866612|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 9V||3.3|-6.8|
71911531|NCT03418051|143343538|SUPERIORITY|||||||0.568||||||A priori threshold set to 0.05.|ANOVA|||||||0.568
71911532|NCT03418051|143343539|SUPERIORITY|||||||0.919||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.919
71911533|NCT03418051|143343539|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
71911534|NCT03418051|143343540|SUPERIORITY|||||||0.796||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.796
71911535|NCT03418051|143343540|SUPERIORITY|||||||0.558||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.558
71682725|NCT03578146|142883635|SUPERIORITY||Least Squares Means (Difference)|-189.57|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682726|NCT03578146|142883635|SUPERIORITY||Least Squares Means (Difference)|-239.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682727|NCT03578146|142883635|SUPERIORITY||Least Squares Means (Difference)|-231.12|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682728|NCT03578146|142883636|SUPERIORITY||Least Squares Means (Difference)|52837.94|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682729|NCT03578146|142883636|SUPERIORITY||Least Squares Means (Difference)|110388.3|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682730|NCT03578146|142883636|SUPERIORITY||Least Squares Means (Difference)|163880.7|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71866613|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 14||4.3|-4.6|
71866614|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.3|||Chan and Zhang|||Common serotypes - serotype 18C||4.3|-4.6|
71866615|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||TWO_SIDED|95.0|-6.8|3.3|||Chan and Zhang|||Common serotypes - serotype 19F||3.3|-6.8|
71682731|NCT03578146|142883636|SUPERIORITY||Least Squares Means (Difference)|263236.5|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682732|NCT03578146|142883636|SUPERIORITY||Least Squares Means (Difference)|270297.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71911536|NCT03418051|143343541|SUPERIORITY|||||||0.701||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.701
71911537|NCT03418051|143343541|SUPERIORITY|||||||0.68||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.68
71911538|NCT03418051|143343542|SUPERIORITY|||||||0.883||||||A priori threshold set at 0.05.|ANOVA|||||||0.883
71911539|NCT03418051|143343542|SUPERIORITY|||||||0.401||||||A priori threshold set at 0.05.|ANOVA|||||||0.401
71911540|NCT03418051|143343543|SUPERIORITY|||||||0.393||||||A priori threshold set at 0.05.|ANOVA|||||||0.393
71911541|NCT03418051|143343543|SUPERIORITY|||||||0.779||||||A priori threshold set at 0.05.|ANOVA|||||||0.779
71911542|NCT03418051|143343544|SUPERIORITY|||||||0.246||||||A priori threshold set at 0.05.|ANOVA|||||||0.246
71911543|NCT03418051|143343544|SUPERIORITY|||||||0.191||||||A priori threshold set at 0.05.|ANOVA|||||||0.191
71911544|NCT03418051|143343545|SUPERIORITY|||||||0.703||||||A priori threshold set at 0.05.|ANOVA|||||||0.703
71911545|NCT03418051|143343545|SUPERIORITY|||||||0.282||||||A priori threshold set at 0.05.|ANOVA|||||||0.282
71911546|NCT03418051|143343546|SUPERIORITY|||||||0.925||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.925
71911547|NCT03418051|143343546|SUPERIORITY|||||||0.551||||||A priori alpha level was set to 0.05.|ANOVA|||||||0.551
71911548|NCT03418051|143343547|SUPERIORITY|||||||0.506||||||A priori threshold set at 0.05.|ANOVA|||||||0.506
71911549|NCT03418051|143343547|SUPERIORITY|||||||0.753||||||A priori threshold at 0.05.|ANOVA|||||||0.753
71911550|NCT03418051|143343548|SUPERIORITY|||||||0.777||||||A priori threshold set at 0.05.|ANOVA|||||||0.777
71911551|NCT03418051|143343548|SUPERIORITY|||||||0.475||||||A priori threshold set at 0.05.|ANOVA|||||||0.475
71911552|NCT03418051|143343549|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
71911553|NCT03418051|143343549|SUPERIORITY|||||||0.042||||||A priori threshold set at 0.05.|ANOVA|||||||0.042
71911554|NCT03418051|143343550|SUPERIORITY|||||||0.738||||||A priori threshold set at 0.05.|ANOVA|||||||0.738
71911555|NCT03418051|143343550|SUPERIORITY|||||||0.83||||||A priori threshold set at 0.05.|ANOVA|||||||0.830
71911556|NCT03418051|143343551|SUPERIORITY|||||||0.7||||||A priori threshold set at 0.05.|ANOVA|||||||0.700
71911557|NCT03418051|143343551|SUPERIORITY|||||||0.492||||||A priori threshold set at 0.05.|ANOVA|||||||0.492
71911558|NCT03418051|143343552|SUPERIORITY|||||||0.82||||||A priori threshold set at 0.05.|ANOVA|||||||0.820
71911559|NCT03418051|143343552|SUPERIORITY|||||||0.526||||||A priori threshold set at 0.05.|ANOVA|||||||0.526
71911560|NCT02193828|143343565|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
71911561|NCT02193828|143343565|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
71682733|NCT03578146|142883637|SUPERIORITY||Least Squares Means (Difference)|-9.91||||0.002|TWO_SIDED||||||ANCOVA|||||||0.002
71911562|NCT02193828|143343565|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||For surface area||||<.0001
71911563|NCT02193828|143343565|SUPERIORITY_OR_OTHER|||||||0.0713|TWO_SIDED||||||ANOVA|||For surface area||||.0713
71911564|NCT02193828|143343565|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||ANOVA|||For volume||||.0002
71911565|NCT02193828|143343565|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
71911566|NCT02193828|143343565|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||For volume||||.0001
71911567|NCT02193828|143343565|SUPERIORITY_OR_OTHER|||||||0.0446|TWO_SIDED||||||ANOVA|||For volume||||.0446
71911568|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.2431|TWO_SIDED||||||ANOVA|||For surface area||||.2431
71911569|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.0625|TWO_SIDED||||||ANOVA|||For surface area||||.0625
71911570|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANOVA|||For surface area||||.3409
71911571|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.704|TWO_SIDED||||||ANOVA|||For surface area||||.7040
71911572|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.3556|TWO_SIDED||||||ANOVA|||For volume||||0.3556
71682734|NCT03578146|142883637|SUPERIORITY||Least Squares Means (Difference)|-15.06|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71911573|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.1275|TWO_SIDED||||||ANOVA|||For volume||||.1275
71911574|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.7883|TWO_SIDED||||||ANOVA|||For volume||||.7883
71911575|NCT02193828|143343566|SUPERIORITY_OR_OTHER|||||||0.9123|TWO_SIDED||||||ANOVA|||For volume||||.9123
71911576|NCT02193828|143343567|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Kruskal-Wallis|||||||.0002
71911577|NCT02193828|143343567|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<.0001
71911578|NCT02193828|143343567|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0002
71911579|NCT02193828|143343567|SUPERIORITY_OR_OTHER|||||||0.0139|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0139
71911580|NCT02193828|143343568|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED||||||ANOVA|||||||.0004
71911581|NCT02193828|143343568|SUPERIORITY_OR_OTHER|||||||0.0075|TWO_SIDED||||||ANOVA|||||||.0075
71911582|NCT02193828|143343568|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|||||||<.0001
71911583|NCT02193828|143343568|SUPERIORITY_OR_OTHER|||||||0.0031|TWO_SIDED||||||ANOVA|||||||.0031
71911584|NCT02193828|143343569|SUPERIORITY_OR_OTHER|||||||0.3135|TWO_SIDED||||||ANOVA|||||||.3135
71911585|NCT02193828|143343569|SUPERIORITY_OR_OTHER|||||||0.7249|TWO_SIDED||||||ANOVA|||||||.7249
71911586|NCT02193828|143343569|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED||||||ANOVA|||||||.1573
71911587|NCT02193828|143343569|SUPERIORITY_OR_OTHER|||||||0.1234|TWO_SIDED||||||ANOVA|||||||.1234
71911588|NCT02193828|143343570|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Kruskal-Wallis|||||||.0006
71911589|NCT02193828|143343570|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0014
71911590|NCT02193828|143343570|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0012
71911591|NCT02193828|143343570|SUPERIORITY_OR_OTHER|||||||0.1298|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.1298
71911592|NCT02193828|143343571|SUPERIORITY_OR_OTHER|||||||0.0048|TWO_SIDED||||||Kruskal-Wallis|||||||.0048
71911593|NCT02193828|143343571|SUPERIORITY_OR_OTHER|||||||0.0034|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0034
71911594|NCT02193828|143343571|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.0079
71911595|NCT02193828|143343571|SUPERIORITY_OR_OTHER|||||||0.3216|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.3216
71911596|NCT02193828|143343572|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Fisher Exact|||||||.0065
71911597|NCT02193828|143343572|SUPERIORITY_OR_OTHER|||||||0.0349|TWO_SIDED||||||Fisher Exact|||||||.0349
71911598|NCT02193828|143343572|SUPERIORITY_OR_OTHER|||||||0.0033|TWO_SIDED||||||Fisher Exact|||||||.0033
71911599|NCT02193828|143343572|SUPERIORITY_OR_OTHER|||||||0.3423|TWO_SIDED||||||Fisher Exact|||||||.3423
71911600|NCT01686958|143343590|OTHER|This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.|||||||ONE_SIDED|95.0||||Confidence intervals \[CI\] will be constructed for outcomes of interest at the alpha=0.05 level of significance, i.e. 95% CI.||||A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.|For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.|||
71911601|NCT00187889|143343598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.6|STANDARD_ERROR_OF_MEAN|6.7||0.15|TWO_SIDED|95.0|-22.8|3.6||The P-value applies to this comparison, without adjustment, to the completers of the trial.|Satterthwaite corrected t-test||An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.|The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.||3.6|-22.8|0.15
71911602|NCT00187889|143343598|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.39||0.92|TWO_SIDED|95.0|-0.79|0.72|||Satterthwaite corrected t-test||The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.|The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.||0.72|-0.79|0.92
71911603|NCT01998880|143343611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.36|0.59||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.59|0.36|<0.0001
71911604|NCT01998880|143343613|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.31|0.5|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.50|0.31|<0.0001
71911605|NCT01998880|143343614|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2841|TWO_SIDED|95.0|0.61|1.16|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||1.16|0.61|0.2841
71911606|NCT01998880|143343615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.31|||<|0.0001|TWO_SIDED|95.0|23.5|45.1|||Chi-squared|||||45.1|23.5|<0.0001
71911607|NCT01998880|143343617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.35|0.61|||Log-ranked, Stratified||Stratified by Binet stage at Baseline.|||0.61|0.35|<0.0001
71911608|NCT01998880|143343621|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.4|||<|0.0001|TWO_SIDED|95.0|0.3|0.53|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.53|0.30|<0.0001
71911609|NCT01998880|143343622|SUPERIORITY_OR_OTHER||Hazard Ratio (stratified)|0.45|||<|0.0001|TWO_SIDED|95.0|0.31|0.65|||Log Rank, Stratified||Stratified by Binet stage at Baseline.|||0.65|0.31|<0.0001
71911610|NCT01998880|143343623|SUPERIORITY||Difference in Response Rates|33.04|||<|0.0001|TWO_SIDED|95.0|22.1|43.9|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.||43.9|22.1|< 0.0001
71911611|NCT01575899|143343644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.629|STANDARD_ERROR_OF_MEAN|3.1526||0.008|TWO_SIDED|95.0|1.28|5.42|||Chi-squared|||||5.42|1.28|0.008
71682735|NCT03578146|142883637|SUPERIORITY||Least Squares Means (Difference)|-17.53|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682736|NCT03578146|142883637|SUPERIORITY||Least Squares Means (Difference)|-17.05|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71911612|NCT01575899|143343646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.87|STANDARD_ERROR_OF_MEAN|3.2589||0.004|TWO_SIDED|95.0|1.5|10.02|||Chi-squared|||||10.02|1.5|0.004
71911613|NCT00141037|143343750|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon Nonparametric Test|||The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.||||0.79
71911614|NCT00141037|143343751|SUPERIORITY_OR_OTHER|||||||0.85|||||||Fisher Exact|||The difference was analyzed using a Fisher's exact test.||||0.85
71911615|NCT00861380|143343759|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|100.0|||<|0.0001|TWO_SIDED|95.0|82.8|100.0||P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 =(vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||100|82.8|<0.0001
71911616|NCT00861380|143343760|SUPERIORITY|VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1vsControl). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect.|VE (1-RR)|91.8|||=|0.0009|TWO_SIDED|95.0|58.3|99.6||p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints.|Regression, Linear|||Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type \[VT\] IPD VE = 0%) was lower than (\<) 5%.||99.6|58.3|= 0.0009
71922274|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|2.66|||TWO_SIDED|95.0|-1.17|9.88|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||9.88|-1.17|
71922275|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.41|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|95.0|-0.14|10.96|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 0-4 hours||10.96|-0.14|
71682737|NCT03578146|142883637|SUPERIORITY||Least Squares Means (Difference)|-19.33|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71682738|NCT01260584|142883673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7|STANDARD_ERROR_OF_MEAN|4.11||0.0624|TWO_SIDED|95.0|-0.4|15.8|||Mixed Models Analysis|||For the sample size calculations for the co-primary endpoints, no Type 1 error rate was adjusted and both co-primary endpoints will be tested at the 0.05 level.||15.8|-0.4|0.0624
71866616|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-5.0|||||TWO_SIDED|95.0|-12.3|-0.3|||Chan and Zhang|||Common serotypes - serotype 23F||-0.3|-12.3|
71866617|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|96.3|||||TWO_SIDED|95.0|89.4|99.2|||Chan and Zhang|||Additional serotypes - serotype 1||99.2|89.4|
71866618|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.1|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 3||98.6|87.7|
71866619|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|37.2|||||TWO_SIDED|95.0|26.2|48.9|||Chan and Zhang|||Additional serotypes - serotype 5||48.9|26.2|
71866620|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|22.9|||||TWO_SIDED|95.0|14.4|33.4|||Chan and Zhang|||Additional serotypes - serotype 6A||33.4|14.4|
71866621|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|97.6|||||TWO_SIDED|95.0|91.6|99.7|||Chan and Zhang|||Additional serotypes - serotype 7F||99.7|91.6|
71866622|NCT00688870|143249753|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.5|||Chan and Zhang|||Additional serotypes - serotype 19A||4.5|-4.6|
71866623|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 4||3.1|-6.9|
71866624|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 6B||4.4|-4.6|
71866625|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 9V||3.1|-6.9|
71866626|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 14||4.4|-4.6|
71866627|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 18C||4.4|-4.6|
71866628|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||TWO_SIDED|95.0|-6.9|3.1|||Chan and Zhang|||Common serotypes - serotype 19F||3.1|-6.9|
71866629|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Common serotypes - serotype 23F||4.4|-4.6|
71866630|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.0|||||TWO_SIDED|95.0|87.7|98.6|||Chan and Zhang|||Additional serotypes - serotype 1||98.6|87.7|
71866631|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|82.5|||||TWO_SIDED|95.0|72.0|90.1|||Chan and Zhang|||Additional serotypes - serotype 3||90.1|72.0|
71866632|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|9.6|||||TWO_SIDED|95.0|3.8|18.1|||Chan and Zhang|||Additional serotypes - serotype 5||18.1|3.8|
71682739|NCT01260584|142883673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.8|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|95.0|25.1|38.4|||Mixed Models Analysis|||||38.4|25.1|<0.0001
71682740|NCT01260584|142883673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|4.08||0.244|TWO_SIDED|95.0|-3.3|12.8|||Mixed Models Analysis|||||12.8|-3.3|0.2440
71682741|NCT01260584|142883673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|34.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|28.4|41.0|||Mixed Models Analysis|||||41.0|28.4|<0.0001
71866633|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||TWO_SIDED|95.0|-4.6|4.4|||Chan and Zhang|||Additional serotypes - serotype 6A||4.4|-4.6|
71866634|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|93.8|||||TWO_SIDED|95.0|86.0|97.9|||Chan and Zhang|||Additional serotypes - serotype 7F||97.9|86.0|
71866635|NCT00688870|143249754|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.2|||||TWO_SIDED|95.0|-3.4|6.5|||Chan and Zhang|||Additional serotypes - serotype 19A||6.5|-3.4|
71866636|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.62|||||TWO_SIDED|95.0|0.5|0.78|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.78|0.50|
71866637|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.91|||||TWO_SIDED|95.0|0.7|1.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.17|0.70|
71866638|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.67|||||TWO_SIDED|95.0|0.55|0.82|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||0.82|0.55|
71866639|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.67|1.06|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||1.06|0.67|
71866640|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.78|||||TWO_SIDED|95.0|0.63|0.97|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.97|0.63|
71911617|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|14.657|||||TWO_SIDED|95.0|13.229|16.197|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.197|13.229|
71922276|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.88|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|0.36|9.4|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||9.40|0.36|
71866641|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.6|0.94|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||0.94|0.60|
71866642|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.59|||||TWO_SIDED|95.0|0.46|0.77|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.77|0.46|
71866643|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|202.58|||||TWO_SIDED|95.0|157.04|261.32|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||261.32|157.04|
71866644|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|24.11|||||TWO_SIDED|95.0|18.46|31.49|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||31.49|18.46|
71866645|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.69|||||TWO_SIDED|95.0|4.37|7.41|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||7.41|4.37|
71866646|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|5.82|||||TWO_SIDED|95.0|4.42|7.67|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||7.67|4.42|
71866647|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|96.1|||||TWO_SIDED|95.0|75.6|122.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||122.17|75.60|
71866648|NCT00688870|143249755|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||1.83|1.23|
71866649|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMC|0.64|||||TWO_SIDED|95.0|0.49|0.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4||0.84|0.49|
71866650|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.03|||||TWO_SIDED|95.0|0.77|1.36|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B||1.36|0.77|
71866651|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.82|||||TWO_SIDED|95.0|0.64|1.05|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V||1.05|0.64|
71866652|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.68|||||TWO_SIDED|95.0|0.51|0.91|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14||0.91|0.51|
71866653|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.75|||||TWO_SIDED|95.0|0.57|0.99|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C||0.99|0.57|
71866654|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|1.09|||||TWO_SIDED|95.0|0.83|1.43|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F||1.43|0.83|
71911618|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|13.582|||||TWO_SIDED|95.0|11.691|15.693|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.693|11.691|
71682742|NCT01260584|142883673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.0|STANDARD_ERROR_OF_MEAN|4.14|<|0.0001|TWO_SIDED|95.0|18.8|35.2|||Mixed Models Analysis|||||35.2|18.8|<0.0001
71922277|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.18|||TWO_SIDED|95.0|-0.22|8.83|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 4-8 hours||8.83|-0.22|
71922278|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.04|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-0.65|8.72|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||8.72|-0.65|
71866655|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|0.69|||||TWO_SIDED|95.0|0.52|0.92|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F||0.92|0.52|
71866656|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|303.73|||||TWO_SIDED|95.0|213.63|431.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1||431.83|213.63|
71682743|NCT01260584|142883674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.2|STANDARD_ERROR_OF_MEAN|12.65||0.0048|TWO_SIDED|95.0|-61.1|-11.2|||Mixed Models Analysis|||||-11.2|-61.1|0.0048
71866657|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|10.65|||||TWO_SIDED|95.0|7.77|14.62|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3||14.62|7.77|
71866658|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.79|||||TWO_SIDED|95.0|3.78|6.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5||6.08|3.78|
71866659|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|3.05|||||TWO_SIDED|95.0|2.28|4.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A||4.08|2.28|
71866660|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|105.0|||||TWO_SIDED|95.0|75.6|145.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F||145.84|75.60|
71866661|NCT00688870|143249756|SUPERIORITY_OR_OTHER_LEGACY||ratio of GMCs|4.45|||||TWO_SIDED|95.0|3.54|5.6|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A||5.60|3.54|
71866662|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.735
71866663|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.533
71682744|NCT01260584|142883674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-93.8|STANDARD_ERROR_OF_MEAN|11.54|<|0.0001|TWO_SIDED|95.0|-116.7|-71.0|||Mixed Models Analysis|||||-71.0|-116.7|<0.0001
71682745|NCT01260584|142883674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.2|STANDARD_ERROR_OF_MEAN|12.53||0.0924|TWO_SIDED|95.0|-45.9|3.5|||Mixed Models Analysis|||||3.5|-45.9|0.0924
71866664|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.039
71866665|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.059||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.059
71866666|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||>0.99
71866667|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||>0.99
71866668|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71866669|NCT00688870|143249757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.275
71866670|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
71866671|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.617||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||0.617
71911619|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|8.452|||||TWO_SIDED|95.0|7.376|9.639|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.639|7.376|
71682746|NCT01260584|142883674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-108.8|STANDARD_ERROR_OF_MEAN|10.85|<|0.0001|TWO_SIDED|95.0|-130.3|-87.3|||Mixed Models Analysis|||||-87.3|-130.3|<0.0001
71866672|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.810
71866673|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.810
71866674|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.674||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.674
71866675|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71866676|NCT00688870|143249758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.497||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.497
71866677|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||>0.99
71866678|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.||||>0.99
71866679|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.044
71866680|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||0.076
71866681|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.496
71866682|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.361||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.361
71866683|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.635||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||0.635
71866684|NCT00688870|143249759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.244
71866685|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.076||95.0|||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.||||0.076
71866686|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.735||95.0|||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.||||0.735
71866687|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71866688|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.||||0.477
71866689|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.805||95.0|||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.||||0.805
71866690|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.||||>0.99
71866691|NCT00688870|143249760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.477||95.0|||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.||||0.477
71866692|NCT00688870|143249761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.633||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.633
71866693|NCT00688870|143249761|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
71866694|NCT00688870|143249761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.527||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.527
71866695|NCT00688870|143249761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.613||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.613
71866696|NCT00688870|143249761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.753
71866697|NCT00688870|143249761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.748||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.748
71866698|NCT00688870|143249762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.327
71866699|NCT00688870|143249762|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
71866700|NCT00688870|143249762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.522
71911620|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|7.603|||||TWO_SIDED|95.0|6.206|9.221|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.221|6.206|
71866701|NCT00688870|143249762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.872||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.872
71866702|NCT00688870|143249762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.868||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.868
71911621|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735.|PYAR|1.637|||||TWO_SIDED|95.0|1.185|2.205|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.205|1.185|
71922279|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|2.26|STANDARD_ERROR_OF_MEAN|2.26|||TWO_SIDED|95.0|-2.42|6.94|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 8-12 hours||6.94|-2.42|
71922280|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|6.9|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|1.91|11.89|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.89|1.91|
71922281|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|6.15|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|1.22|11.08|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 12-16 hours||11.08|1.22|
71866703|NCT00688870|143249762|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.237
71866704|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.329||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.329
71866705|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.492||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||0.492
71866706|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.496||95.0|||||Fisher Exact|||For Fever \>40 degrees C, Fisher exact test was used to calculate p-value.||||0.496
71866707|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.322||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.322
71866708|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||0.610
71866709|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.726||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||0.726
71922282|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.99|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|0.05|9.93|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||9.93|0.05|
71866710|NCT00688870|143249763|SUPERIORITY_OR_OTHER_LEGACY|||||||0.855||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.855
71866711|NCT00688870|143249764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.326||95.0|||||Fisher Exact|||For Fever \>=38 but \<=39 degrees C, Fisher exact test was used to calculate p-value.||||0.326
71866712|NCT00688870|143249764|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Fever \>39 but \<=40 degrees C, Fisher exact test was used to calculate p-value.||||>0.99
71866713|NCT00688870|143249764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714||95.0|||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.||||0.714
71866714|NCT00688870|143249764|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.||||>0.99
71866715|NCT00688870|143249764|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99||95.0|||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.||||>0.99
71866716|NCT00688870|143249764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525||95.0|||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.||||0.525
71866717|NCT01821352|143249777|SUPERIORITY_OR_OTHER||||||<|5e-05|TWO_SIDED||||||Fisher Exact|||||||<0.00005
71866718|NCT01821352|143249778|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71866719|NCT01821352|143249779|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71682747|NCT01260584|142883674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.6|STANDARD_ERROR_OF_MEAN|12.73|<|0.0001|TWO_SIDED|95.0|-97.8|-47.5|||Mixed Models Analysis|||||-47.5|-97.8|<0.0001
71682748|NCT01260584|142883675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.6|STANDARD_ERROR_OF_MEAN|3.72||0.0423|TWO_SIDED|95.0|-15.0|-0.3|||Mixed Models Analysis|||||-0.3|-15.0|0.0423
71682749|NCT01260584|142883675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.7|STANDARD_ERROR_OF_MEAN|3.19|<|0.0001|TWO_SIDED|95.0|-29.0|-16.4|||Mixed Models Analysis|||||-16.4|-29.0|<0.0001
71682750|NCT01260584|142883675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.7||0.1184|TWO_SIDED|95.0|-13.1|1.5|||Mixed Models Analysis|||||1.5|-13.1|0.1184
71682751|NCT01260584|142883675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.5|STANDARD_ERROR_OF_MEAN|3.02|<|0.0001|TWO_SIDED|95.0|-30.5|-18.5|||Mixed Models Analysis|||||-18.5|-30.5|<0.0001
71866720|NCT02917603|143249782|EQUIVALENCE|Null hypothesis is that there would be no mean difference between baseline and last measure between intervention and control groups with p\<.05|Mean Difference (Net)|0.12|||<|0.009|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the mean differences between baseline and last measure in the PHQ- 9 score will not differ between groups. Study is powered a two-tailed test of significance, allowing the detection of a significant difference in either direction and the following assumptions: expected difference in PHQ-9 is 5 points, the documented clinically significant effect;78 (2) the variance of scores is 5.33; (3) error protection: α =.10, β = .20 and, (4) anticipated attrition of 15%||||<.009
71866721|NCT02917603|143249783|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.46|||<|0.21|TWO_SIDED||||||t-test, 2 sided|||||||<.21
71866722|NCT02917603|143249784|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|1.02|||<|0.06|TWO_SIDED||||||t-test, 2 sided|||||||<.06
71682752|NCT01260584|142883675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|3.76|<|0.0001|TWO_SIDED|95.0|-24.3|-9.5|||Mixed Models Analysis|||||-9.5|-24.3|<0.0001
71911622|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702.|PYAR|1.845|||||TWO_SIDED|95.0|1.194|2.724|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.724|1.194|
71911623|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as . 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 2626735.|PYAR|3.997|||||TWO_SIDED|95.0|3.269|4.839|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||4.839|3.269|
71911624|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 1354702.|PYAR|3.322|||||TWO_SIDED|95.0|2.423|4.445|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||4.445|2.423|
71911625|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|14.487|||||TWO_SIDED|95.0|13.071|16.015|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||16.015|13.071|
71911626|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|13.74|||||TWO_SIDED|95.0|11.841|15.857|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||15.857|11.841|
71911627|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|7.813|||||TWO_SIDED|95.0|6.782|8.955|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||8.955|6.782|
71911628|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|7.789|||||TWO_SIDED|95.0|6.377|9.42|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.420|6.377|
71922283|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.34|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|0.45|10.22|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 16-20 hours||10.22|0.45|
71866723|NCT02917603|143249785|EQUIVALENCE|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.23|||<|0.73|TWO_SIDED||||||t-test, 2 sided|||||||<.73
71866724|NCT01253018|143249786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||"Sample size and power calculations were performed based on the difference in the FM score between the two groups with an assumed within group SD of 15.9, the correlation of 0.5 among repeated measures. 30 subjects enrolled in each arm of the study would give 80% power for detecting a difference of 8 points on the FM.~Two sample t-tests were conducted to compare changes in FM between the two interventions groups at final training (12 week)."||||<0.05
71866725|NCT01253018|143249786|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in FM between the two interventions groups at retention (24 weeks).||||<0.05
71866726|NCT01253018|143249788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at final training 12 week.||||<0.05
71866727|NCT01253018|143249788|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at retention 24 weeks.||||<0.05
71866728|NCT01253018|143249789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at final training week 12.||||<0.05
71866729|NCT01253018|143249789|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at retention week 24.||||<0.05
71866730|NCT05260021|143249841|SUPERIORITY||LS Mean difference (Final Values)|-1.8|||<|0.001|TWO_SIDED|95.0|-2.35|-1.25|||ANCOVA|||||-1.25|-2.35|<0.001
71911629|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|2.313|||||TWO_SIDED|95.0|1.77|2.972|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||2.972|1.770|
71866731|NCT05260021|143249842|SUPERIORITY||LS Mean difference (Final Values)|-1.67|||<|0.001|TWO_SIDED|95.0|-2.31|-1.02|||ANCOVA|||||-1.02|-2.31|<0.001
71866732|NCT05260021|143249842|SUPERIORITY||LS Mean difference (Final Values)|-1.93|||<|0.001|TWO_SIDED|95.0|-2.57|-1.29|||ANCOVA|||||-1.29|-2.57|<0.001
71866733|NCT05260021|143249843|SUPERIORITY||Risk Difference (RD)|40.1|||<|0.001|TWO_SIDED|95.0|18.6|61.7|||Regression, Logistic|||||61.7|18.6|<0.001
71866734|NCT05260021|143249843|SUPERIORITY||Risk Difference (RD)|51.6|||<|0.001|TWO_SIDED|95.0|31.1|72.2|||Regression, Logistic|||||72.2|31.1|<0.001
71866735|NCT05260021|143249843|SUPERIORITY||Risk Difference (RD)|45.8|||<|0.001|TWO_SIDED|95.0|27.5|64.1|||Regression, Logistic|||||64.1|27.5|<0.001
71866736|NCT05260021|143249844|SUPERIORITY||LS Mean difference (Final Values)|-0.36|||<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||||-0.16|-0.55|< 0.001
71866737|NCT05260021|143249844|SUPERIORITY||LS Mean difference (Final Values)|-0.66|||<|0.001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA|||||-0.47|-0.86|<0.001
71866738|NCT05260021|143249844|SUPERIORITY||LS Mean difference (Final Values)|-0.51|||<|0.001|TWO_SIDED|95.0|-0.68|-0.34|||ANCOVA|||||-0.34|-0.68|< 0.001
71866739|NCT05260021|143249845|SUPERIORITY||LS Mean difference (Final Values)|-28.9||||0.007|TWO_SIDED|95.0|-49.7|-8.0|||ANCOVA|||||-8.0|-49.7|0.007
71866740|NCT05260021|143249845|SUPERIORITY||LS Mean difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-64.3|-23.6|||ANCOVA|||||-23.6|-64.3|< 0.001
71866741|NCT05260021|143249845|SUPERIORITY||LS Mean difference (Final Values)|-36.4|||<|0.001|TWO_SIDED|95.0|-54.2|-18.6|||ANCOVA|||||-18.6|-54.2|< 0.001
71866742|NCT05260021|143249846|SUPERIORITY||LS Mean difference (Final Values)|-6.18|||<|0.001|TWO_SIDED|95.0|-9.31|-3.05|||ANCOVA|||||-3.05|-9.31|< 0.001
71866743|NCT05260021|143249846|SUPERIORITY||LS Mean difference (Final Values)|-10.52|||<|0.001|TWO_SIDED|95.0|-13.67|-7.38|||ANCOVA|||||-7.38|-13.67|< 0.001
71866744|NCT05260021|143249846|SUPERIORITY||LS Mean difference (Final Values)|-8.35|||<|0.001|TWO_SIDED|95.0|-11.05|-5.66|||ANCOVA|||||-5.66|-11.05|< 0.001
71866745|NCT05260021|143249847|SUPERIORITY||Risk Difference (RD)|29.5||||0.006|TWO_SIDED|95.0|8.6|50.3|||Regression, Logistic|||||50.3|8.6|0.006
71866746|NCT05260021|143249847|SUPERIORITY||Risk Difference (RD)|39.5|||<|0.001|TWO_SIDED|95.0|18.8|60.2|||Regression, Logistic|||||60.2|18.8|< 0.001
71866747|NCT05260021|143249847|SUPERIORITY||Risk Difference (RD)|34.6|||<|0.001|TWO_SIDED|95.0|17.0|52.1|||Regression, Logistic|||||52.1|17|< 0.001
71866748|NCT05260021|143249848|SUPERIORITY||Risk Difference (RD)|43.4|||<|0.001|TWO_SIDED|95.0|22.3|64.4|||Regression, Logistic|||||64.4|22.3|< 0.001
71866749|NCT05260021|143249848|SUPERIORITY||Risk Difference (RD)|47.1|||<|0.001|TWO_SIDED|95.0|26.4|67.7|||Regression, Logistic|||||67.7|26.4|< 0.001
71866750|NCT05260021|143249848|SUPERIORITY||Risk Difference (RD)|45.2|||<|0.001|TWO_SIDED|95.0|26.3|64.1|||Regression, Logistic|||||64.1|26.3|< 0.001
71866751|NCT05260021|143249850|SUPERIORITY||LS Mean difference (Final Values)|0.014||||0.708|TWO_SIDED|95.0|-0.061|0.089|||Mixed Models Analysis|||||0.089|-0.061|0.708
71866752|NCT05260021|143249850|SUPERIORITY||LS Mean difference (Final Values)|-0.001||||0.976|TWO_SIDED|95.0|-0.076|0.074|||Mixed Models Analysis|||||0.074|-0.076|0.976
71866753|NCT05260021|143249850|SUPERIORITY||LS Mean difference (Final Values)|0.007||||0.841|TWO_SIDED|95.0|-0.058|0.071|||Mixed Models Analysis|||||0.071|-0.058|0.841
71866754|NCT05260021|143249851|SUPERIORITY||LS Mean difference (Final Values)|-0.29|||<|0.001|TWO_SIDED|95.0|-0.45|-0.12|||Mixed Models Analysis|||||-0.12|-0.45|< 0.001
71682753|NCT01260584|142883676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.1331|TWO_SIDED|95.0|0.8|5.32|||Regression, Logistic|||||5.32|0.80|0.1331
71866755|NCT05260021|143249851|SUPERIORITY||LS Mean difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.57|-0.24|||Mixed Models Analysis|||||-0.24|-0.57|< 0.001
71866756|NCT05260021|143249851|SUPERIORITY||LS Mean difference (Final Values)|-0.34|||<|0.001|TWO_SIDED|95.0|-0.49|-0.2|||Mixed Models Analysis|||||-0.2|-0.49|< 0.001
71866757|NCT03843554|143249863|SUPERIORITY|Primary hypothesis. Null hypothesis is that the proportion of patients with a successful outcome of WHO OM severity grades 0-2 at the post study evaluation will not differ between the two randomized intervention groups. The estimated proportion of successes from our pilot trial is 0.30 with SOC. The alternative hypothesis is that the proportion of patients with a successful outcome differs between the two groups from the SOC proportion of 0.30 by +/-0.265 or more.||||||0.999|||||||Fisher Exact|OM WHO grading scale (less or equal to 2) severity employed a two-sided Fisher's exact test to compare the two arms at Visit 9.||||||0.999
71866758|NCT03843554|143249864|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|174.6||0.6336|TWO_SIDED|95.0||||The above t-test p-value is for IL1a.|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t-test was used to compare the change in inflammatory markers between the two groups.||||0.6336
71866759|NCT03843554|143249864|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|52.1||0.351|TWO_SIDED|95.0||||IL1b|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
71866760|NCT03843554|143249864|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-102.2|STANDARD_ERROR_OF_MEAN|252.8||0.351|TWO_SIDED|95.0||||IL2|t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.3510
71866761|NCT03843554|143249864|SUPERIORITY|IL4|Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|46.0||0.8371|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.8371
71866762|NCT03843554|143249864|SUPERIORITY|IL5|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|10.7||0.2991|TWO_SIDED|95.0|||||t-test, 2 sided|||The change in the inflammatory marker from baseline to the final intervention visit was analyzed using 95% confidence intervals and presented by treatment group. The two-sided t- test was used to compare the change in inflammatory markers between the two groups.||||0.2991
71866763|NCT03843554|143249865|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.2293|STANDARD_ERROR_OF_MEAN|0.8555||0.2373|TWO_SIDED|95.0|-1.906|1.4475|||t-test, 2 sided|||||1.4475|-1.9060|0.2373
71866764|NCT03843554|143249866|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|0.0569|STANDARD_ERROR_OF_MEAN|0.116||0.6263|TWO_SIDED|95.0|-0.1755|0.2893||A Week 8 general linear mixed effects model (GLM) was used to compare the change in saliva flow rate from Baseline (day 0) to week 8 (day 56) between the two groups. The change was calculated by subtracting week 8 saliva flow rate from the Baseline.|ANCOVA||Estimation of the difference in least-square means for the change from Baseline to FIV in saliva flow rate.|||0.2893|-0.1755|0.6263
71866765|NCT03843554|143249867|SUPERIORITY|OMDP-STANDARD|Mean Difference (Net)|-1.94||||0.6956|TWO_SIDED|95.0|||||Regression, Linear|A Week 8 (Day 56) GLM analyzing the pain change Week 8 relative to Baseline (Day 0) was used with treatment and Baseline pain as covariates.|Difference in least-square mean change from baseline to Visit 9 in pain score.|||||0.6956
71866766|NCT03843554|143249868|SUPERIORITY|OMDP-STANDARD|Mean Difference (Final Values)|-0.188|STANDARD_ERROR_OF_MEAN|0.113||0.1153|TWO_SIDED|95.0|-0.4095|0.0334|||ANCOVA|ANCOVA via generalized linear mixed repeated measures model (GLMER)||The statistical analysis comprised an ANCOVA for a longitudinal response based on a generalized linear mixed effects repeated measures model (GLMER). The response variable is the mean change from Baseline to Visit 9 in EORTC QLQ-C30 Questions 31-48 (total).||0.0334|-0.4095|0.1153
71866767|NCT03446781|143249883|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.002
71866768|NCT03446781|143249884|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71866769|NCT03446781|143249885|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71682754|NCT01260584|142883676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99||||0.5813|TWO_SIDED|95.0|0.17|23.65|||Regression, Logistic|||||23.65|0.17|0.5813
71682755|NCT01260584|142883676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.54||||0.0127|TWO_SIDED|95.0|1.85|148.23|||Regression, Logistic|||||148.23|1.85|0.0127
71682756|NCT01260584|142883676|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.11||||0.0013|TWO_SIDED|95.0|3.13|93.65|||Regression, Logistic|||||93.65|3.13|0.0013
71682757|NCT01260584|142883677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5684|TWO_SIDED|95.0|0.49|3.67|||Regression, Logistic|||||3.67|0.49|0.5684
71866770|NCT03446781|143249886|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71866771|NCT03446781|143249887|SUPERIORITY|||||||0.033|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||0.033
71866772|NCT03446781|143249888|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71866773|NCT03446781|143249889|SUPERIORITY||||||<|0.001|||||||ANCOVA|With factors of treatment group and analysis center adjusted for baseline values in the model||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71866774|NCT03446781|143249890|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71866775|NCT03446781|143249891|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for analysis center||CCH 0.84 mg/Buttock versus Placebo||||<0.001
71866776|NCT03568318|143249905|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.4|43.8|<0.001
71911630|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|1.984|||||TWO_SIDED|95.0|1.307|2.886|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.886|1.307|
71911631|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =2636783.|PYAR|4.172|||||TWO_SIDED|95.0|3.429|5.028|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.028|3.429|
71911632|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =1360966.|PYAR|3.968|||||TWO_SIDED|95.0|2.981|5.177|||Negative Binomial model without strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.177|2.981|
71911633|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|14.017|||||TWO_SIDED|95.0|12.628|15.516|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||15.516|12.628|
71911634|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|15.066|||||TWO_SIDED|95.0|13.079|17.269|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||17.269|13.079|
71911635|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.916|||||TWO_SIDED|95.0|5.026|6.917|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||6.917|5.026|
71922284|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|1.67|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-3.17|6.52|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||6.52|-3.17|
71922285|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.03|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-0.86|8.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 7, 20-24 hours||8.92|-0.86|
71866777|NCT03568318|143249905|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.1|||<|0.001|TWO_SIDED|95.0|30.8|45.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||45.4|30.8|<0.001
71866778|NCT03568318|143249906|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|47.6|||<|0.001|TWO_SIDED|95.0|41.1|54.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||54.0|41.1|<0.001
71866779|NCT03568318|143249906|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|28.5|||<|0.001|TWO_SIDED|95.0|22.1|34.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response rate difference = Upadacitinib - Placebo|||34.9|22.1|<0.001
71866780|NCT03568318|143249907|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|48.8|||<|0.001|TWO_SIDED|95.0|41.9|55.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||55.7|41.9|<0.001
71866781|NCT03568318|143249907|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|36.8|||<|0.001|TWO_SIDED|95.0|29.7|43.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.8|29.7|<0.001
71866782|NCT03568318|143249908|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|49.9|||<|0.001|TWO_SIDED|95.0|43.3|56.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||56.4|43.3|<0.001
71866783|NCT03568318|143249908|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|29.5|||<|0.001|TWO_SIDED|95.0|22.8|36.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||36.3|22.8|<0.001
71866784|NCT03568318|143249909|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|50.6|||<|0.001|TWO_SIDED|95.0|43.8|57.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||57.3|43.8|<0.001
71866785|NCT03568318|143249909|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.4|||<|0.001|TWO_SIDED|95.0|30.4|44.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.3|30.4|<0.001
71911636|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|8.557|||||TWO_SIDED|95.0|7.077|10.255|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.255|7.077|
71922286|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|4.05|STANDARD_ERROR_OF_MEAN|2.51|||TWO_SIDED|95.0|-1.18|9.27|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||9.27|-1.18|
71922287|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-1.38|8.9|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 0-4 hours||8.90|-1.38|
71866786|NCT03568318|143249910|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|57.6|||<|0.001|TWO_SIDED|95.0|51.2|63.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||63.9|51.2|<0.001
71682758|NCT01260584|142883677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7||||0.0447|TWO_SIDED|95.0|1.05|42.92|||Regression, Logistic|||||42.92|1.05|0.0447
71682759|NCT01260584|142883677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|58.64||||0.0003|TWO_SIDED|95.0|6.8|505.58|||Regression, Logistic|||||505.58|6.80|0.0003
71922288|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.18|STANDARD_ERROR_OF_MEAN|3.31|||TWO_SIDED|95.0|-1.7|12.06|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.06|-1.70|
71682760|NCT01260584|142883677|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.71||||0.0006|TWO_SIDED|95.0|2.95|46.52|||Regression, Logistic|||||46.52|2.95|0.0006
71682761|NCT01260584|142883678|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|110.7|||||TWO_SIDED|90.0|93.7|130.8|||Mixed Models Analysis|||Prasugrel active metabolite R-138727||130.8|93.7|
71682762|NCT01260584|142883678|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|118.4|||||TWO_SIDED|90.0|99.8|140.4|||Mixed Models Analysis|||active metabolite R-130964||140.4|99.8|
71922289|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.61|STANDARD_ERROR_OF_MEAN|3.25|||TWO_SIDED|95.0|-1.14|12.37|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 4-8 hours||12.37|-1.14|
71922290|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|-0.21|STANDARD_ERROR_OF_MEAN|2.47|||TWO_SIDED|95.0|-5.35|4.92|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||4.92|-5.35|
71922291|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|1.61|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.42|6.65|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 8-12 hours||6.65|-3.42|
71922292|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.08|STANDARD_ERROR_OF_MEAN|3.02|||TWO_SIDED|95.0|-1.19|11.36|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.36|-1.19|
71922293|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|5.3|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-0.83|11.42|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 12-16 hours||11.42|-0.83|
71922294|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|1.3|STANDARD_ERROR_OF_MEAN|2.56|||TWO_SIDED|95.0|-4.02|6.63|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||6.63|-4.02|
71922295|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|2.93|STANDARD_ERROR_OF_MEAN|2.5|||TWO_SIDED|95.0|-2.26|8.12|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 16-20 hours||8.12|-2.26|
71922296|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|-1.34|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-7.52|4.85|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.85|-7.52|
71922297|NCT03091920|143365008|OTHER|No statistical testing was performed.|Least squares mean difference|-1.14|STANDARD_ERROR_OF_MEAN|2.94|||TWO_SIDED|95.0|-7.25|4.98|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate.|Day 14, 20-24 hours||4.98|-7.25|
71922298|NCT03091920|143365009|OTHER|No statistical testing was performed.|Least squares mean difference|-0.288|STANDARD_ERROR_OF_MEAN|0.274|||TWO_SIDED|95.0|-0.857|0.282|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.282|-0.857|
71922299|NCT03091920|143365009|OTHER|No statistical testing was performed.|Least squares mean difference|-0.105|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.708|0.498|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.498|-0.708|
71922300|NCT03091920|143365009|OTHER|No statistical testing was performed.|Least squares mean difference|-0.196|STANDARD_ERROR_OF_MEAN|0.255|||TWO_SIDED|95.0|-0.727|0.335|||||Least Squares mean difference and associated 95% CI is from an ANCOVA model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|||0.335|-0.727|
71922301|NCT03091920|143365014|OTHER|No statistical testing was performed.|Least squares mean difference|-23.188|STANDARD_ERROR_OF_MEAN|27.97|||TWO_SIDED|95.0|-84.13|37.753|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||37.753|-84.130|
71922302|NCT03091920|143365014|OTHER|No statistical testing was performed.|Least squares mean difference|-14.033|STANDARD_ERROR_OF_MEAN|26.092|||TWO_SIDED|95.0|-70.883|42.817|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||42.817|-70.883|
71866787|NCT03568318|143249910|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|43.8|||<|0.001|TWO_SIDED|95.0|37.0|50.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||50.5|37.0|<0.001
71911637|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =2654010.|PYAR|2.977|||||TWO_SIDED|95.0|2.357|3.71|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||3.710|2.357|
71911638|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =1367343.|PYAR|2.048|||||TWO_SIDED|95.0|1.361|2.96|||Regression, Linear|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||2.960|1.361|
71911639|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|5.011|||||TWO_SIDED|95.0|4.196|5.939|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||5.939|4.196|
71911640|NCT00861380|143343764|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|4.315|||||TWO_SIDED|95.0|3.285|5.566|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine \& non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||5.566|3.285|
71922303|NCT03091920|143365014|OTHER|No statistical testing was performed.|Least squares mean difference|-18.611|STANDARD_ERROR_OF_MEAN|24.138|||TWO_SIDED|95.0|-71.204|33.982|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 8||33.982|-71.204|
71866788|NCT03568318|143249911|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|37.2|||<|0.001|TWO_SIDED|95.0|31.0|43.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||43.3|31.0|<0.001
71866789|NCT03568318|143249911|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|24.0|||<|0.001|TWO_SIDED|95.0|18.1|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||29.9|18.1|<0.001
71922304|NCT03091920|143365014|OTHER|No statistical testing was performed.|Least squares mean difference|-25.389|STANDARD_ERROR_OF_MEAN|16.885|||TWO_SIDED|95.0|-62.551|11.774|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||11.774|-62.551|
71922305|NCT03091920|143365014|OTHER|No statistical testing was performed.|Least squares mean difference|-21.176|STANDARD_ERROR_OF_MEAN|16.221|||TWO_SIDED|95.0|-56.879|14.527|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||14.527|-56.879|
71866790|NCT03568318|143249912|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|32.8|44.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||44.8|32.8|<0.001
71866791|NCT03568318|143249912|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|23.3|||<|0.001|TWO_SIDED|95.0|17.7|28.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||28.9|17.7|<0.001
71866792|NCT03568318|143249913|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|21.2|||<|0.001|TWO_SIDED|95.0|16.3|26.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||26.1|16.3|<0.001
71866793|NCT03568318|143249914|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|16.2|||<|0.001|TWO_SIDED|95.0|11.3|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.3|<0.001
71866794|NCT03568318|143249914|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer.|Adjusted Response Rate Difference|9.2|||<|0.001|TWO_SIDED|95.0|4.9|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for strata (Baseline vIGA-AD categories and age \[adolescent vs. adult\])|Response Rate Difference = Upadacitinib - Placebo|||13.4|4.9|<0.001
71866795|NCT03568318|143249915|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|Least Squares (LS) Mean Difference|-41.79|STANDARD_ERROR_OF_MEAN|4.417|<|0.001|TWO_SIDED|95.0|-50.46|-33.11|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-33.11|-50.46|<0.001
71866796|NCT03568318|143249915|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes only.|LS Mean Difference|-33.08|STANDARD_ERROR_OF_MEAN|4.403|<|0.001|TWO_SIDED|95.0|-41.72|-24.44|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-24.44|-41.72|<0.001
71866797|NCT03568318|143249916|SUPERIORITY||LS Mean Difference|-41.45|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-46.68|-36.22|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 30 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.||-36.22|-46.68|<0.001
71866798|NCT03568318|143249916|SUPERIORITY|The overall type I error rate of the coprimary and all key secondary endpoints for upadacitinib 15 mg was controlled at the 0.05 level using a graphical multiple testing procedure following a pre-specified α transfer path which includes downstream transfer along the endpoints sequence within each dose as well as cross-dose transfer. This endpoint was a multiplicity-controlled key secondary endpoint for EU/EMA regulatory purposes only.|LS Mean Difference|-32.13|STANDARD_ERROR_OF_MEAN|2.659|<|0.001|TWO_SIDED|95.0|-37.35|-26.91|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, Baseline vIGA-AD category and age in the model.|Difference = Upadacitinib - Placebo|||-26.91|-37.35|<0.001
71866799|NCT03568318|143249917|SUPERIORITY||Adjusted Response Rate Difference|53.1|||<|0.001|TWO_SIDED|95.0|38.8|67.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||67.4|38.8|<0.001
71866800|NCT03568318|143249917|SUPERIORITY||Adjusted Response Rate Difference|32.7|||<|0.001|TWO_SIDED|95.0|16.3|49.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.0|16.3|<0.001
71866801|NCT03568318|143249918|SUPERIORITY||Adjusted Response Rate Difference|55.4|||<|0.001|TWO_SIDED|95.0|41.4|69.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||69.5|41.4|<0.001
71866802|NCT03568318|143249918|SUPERIORITY||Adjusted Response Rate Difference|26.3|||<|0.001|TWO_SIDED|95.0|12.1|40.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.4|12.1|<0.001
71866803|NCT03568318|143249919|SUPERIORITY||Adjusted Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|14.1|46.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||46.8|14.1|<0.001
71866804|NCT03568318|143249919|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.003|TWO_SIDED|95.0|8.2|40.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.8|8.2|0.003
71866805|NCT03568318|143249920|SUPERIORITY||Adjusted Response Rate Difference|52.0|||<|0.001|TWO_SIDED|95.0|37.3|66.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||66.7|37.3|<0.001
71866806|NCT03568318|143249920|SUPERIORITY||Adjusted Response Rate Difference|27.1||||0.001|TWO_SIDED|95.0|11.1|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|11.1|0.001
71911641|NCT00861380|143343772|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2626735.|PYAR|9.218|||||TWO_SIDED|95.0|9.103|9.335|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||9.335|9.103|
71911642|NCT00861380|143343772|OTHER|In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1354702.|PYAR|9.212|||||TWO_SIDED|95.0|9.052|9.375|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||9.375|9.052|
71911643|NCT00861380|143343772|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783.|PYAR|10.5|||||TWO_SIDED|95.0|10.378|10.624|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.624|10.378|
71911644|NCT00861380|143343772|OTHER|In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966.|PYAR|10.429|||||TWO_SIDED|95.0|10.259|10.601|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.601|10.259|
71922306|NCT03091920|143365014|OTHER|No statistical testing was performed.|Least squares mean difference|-23.282|STANDARD_ERROR_OF_MEAN|14.691|||TWO_SIDED|95.0|-55.618|9.053|||||Least Squares mean difference and associated 95% confidence interval (CI) is from an analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline as covariate. Standard Error of the Mean=Standard Error of the LS Mean Difference.|Day 15||9.053|-55.618|
71866807|NCT03568318|143249921|SUPERIORITY||Adjusted Response Rate Difference|23.5||||0.006|TWO_SIDED|95.0|6.9|40.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||40.1|6.9|0.006
71866808|NCT03568318|143249921|SUPERIORITY||Adjusted Response Rate Difference|22.7||||0.007|TWO_SIDED|95.0|6.2|39.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||39.2|6.2|0.007
71866809|NCT03568318|143249922|SUPERIORITY||Adjusted Response Rate Difference|49.3|||<|0.001|TWO_SIDED|95.0|34.1|64.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||64.6|34.1|<0.001
71911645|NCT00861380|143343772|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010.|PYAR|10.118|||||TWO_SIDED|95.0|9.997|10.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||10.239|9.997|
71911646|NCT00861380|143343772|OTHER|In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343.|PYAR|9.921|||||TWO_SIDED|95.0|9.755|10.088|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||10.088|9.755|
71911647|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|22.624|||||TWO_SIDED|95.0|22.02|23.24|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||23.240|22.020|
71911648|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|22.747|||||TWO_SIDED|95.0|21.912|23.606|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||23.606|21.912|
71911649|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|24.503|||||TWO_SIDED|95.0|23.852|25.166|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||25.166|23.852|
71911650|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|26.236|||||TWO_SIDED|95.0|25.308|27.189|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.189|25.308|
71682763|NCT01260584|142883679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|117.9|||||TWO_SIDED|90.0|94.4|147.3|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Prasugrel active metabolite R-138727||147.3|94.4|
71682764|NCT01260584|142883679|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|123.8|||||TWO_SIDED|90.0|98.6|155.4|||Mixed Models Analysis||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Clopidogrel active metabolite R-130964||155.4|98.6|
71682765|NCT00824382|142883770|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.091|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.051|0.131|||ANCOVA|||Olodaterol 2mcg - Placebo||0.131|0.051|<0.0001
71682766|NCT00824382|142883770|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.091|0.172|||ANCOVA|||Olodaterol 5mcg - Placebo||0.172|0.091|<0.0001
71682767|NCT00824382|142883770|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.132|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.092|0.172|||ANCOVA|||Olodaterol 10mcg - Placebo||0.172|0.092|<0.0001
71682768|NCT00824382|142883771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.021||0.0002||95.0|0.039|0.124|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.124|0.039|0.0002
71866810|NCT03568318|143249922|SUPERIORITY||Adjusted Response Rate Difference|26.2||||0.002|TWO_SIDED|95.0|9.4|43.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||43.1|9.4|0.002
71866811|NCT03568318|143249923|SUPERIORITY||Adjusted Response Rate Difference|41.5|||<|0.001|TWO_SIDED|95.0|27.8|55.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||55.1|27.8|<0.001
71866812|NCT03568318|143249923|SUPERIORITY||Adjusted Response Rate Difference|24.4||||0.001|TWO_SIDED|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.4|10.3|0.001
71866813|NCT03568318|143249924|SUPERIORITY||Adjusted Response Rate Difference|34.9|||<|0.001|TWO_SIDED|95.0|20.6|49.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||49.3|20.6|<0.001
71866814|NCT03568318|143249924|SUPERIORITY||Adjusted Response Rate Difference|24.5||||0.001|TWO_SIDED|95.0|10.4|38.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||38.7|10.4|0.001
71866815|NCT03568318|143249925|SUPERIORITY||Adjusted Response Rate Difference|19.8||||0.001|TWO_SIDED|95.0|7.8|31.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||31.8|7.8|0.001
71866816|NCT03568318|143249926|SUPERIORITY||Adjusted Response Rate Difference|6.2||||0.306|TWO_SIDED|95.0|-5.7|18.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||18.2|-5.7|0.306
71911651|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|27.502|||||TWO_SIDED|95.0|26.81|28.207|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||28.207|26.810|
71866817|NCT03568318|143249926|SUPERIORITY||Adjusted Response Rate Difference|-1.0||||0.855|TWO_SIDED|95.0|-11.2|9.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratum (Baseline vIGA-AD categories)|Response Rate Difference = Upadacitinib - Placebo|||9.3|-11.2|0.855
71866818|NCT03568318|143249927|SUPERIORITY||LS Mean Difference|-16.05|STANDARD_ERROR_OF_MEAN|11.956||0.18|TWO_SIDED|95.0|-39.59|7.48|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||7.48|-39.59|0.180
71866819|NCT03568318|143249927|SUPERIORITY||LS Mean Difference|-26.38|STANDARD_ERROR_OF_MEAN|11.986||0.029|TWO_SIDED|95.0|-49.97|-2.79|||Mixed Effect Model Repeated Measurement|Mixed-effect model repeat measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-2.79|-49.97|0.029
71866820|NCT03568318|143249928|SUPERIORITY||LS Mean Difference|-35.69|STANDARD_ERROR_OF_MEAN|5.354|<|0.001|TWO_SIDED|95.0|-46.28|-25.11|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-25.11|-46.28|<0.001
71866821|NCT03568318|143249928|SUPERIORITY||LS Mean Difference|-24.37|STANDARD_ERROR_OF_MEAN|5.423|<|0.001|TWO_SIDED|95.0|-35.1|-13.65|||Mixed Effect Model Repeated Measurement|Mixed-Effect Model Repeat Measurement with Baseline, treatment, visit, treatment by visit interaction, and Baseline vIGA-AD category in the model.|Difference = Upadacitinib - Placebo|||-13.65|-35.10|<0.001
71866822|NCT05126563|143249933|SUPERIORITY||LS Means|0.054|STANDARD_ERROR_OF_MEAN|0.738||0.9416|TWO_SIDED|95.0|-1.42|1.53|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Extreme fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.53|-1.42|0.9416
71911652|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|26.1||||||95.0|25.171|27.055|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||27.055|25.171|
71911653|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|28.661|||||TWO_SIDED|95.0|27.958|29.377|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||29.377|27.958|
71911654|NCT00861380|143343780|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|29.835|||||TWO_SIDED|95.0|28.843|30.85|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||30.850|28.843|
71911655|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|816.813|||||TWO_SIDED|95.0|815.226|818.392|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||818.392|815.226|
71911656|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|841.176|||||TWO_SIDED|95.0|839.098|843.239|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||843.239|839.098|
71911657|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978.|PYAR|702.245|||||TWO_SIDED|95.0|700.372|704.114|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for Acute Otitis Media (AOM)/Respiratory Tract Infections (RTI), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||704.114|700.372|
71682769|NCT00824382|142883771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.098|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.184|0.098|<0.0001
71682770|NCT00824382|142883771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.115|0.199|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.199|0.115|<0.0001
71682771|NCT00824382|142883772|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.138|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.095|0.182|||ANCOVA|||Olodaterol 2mcg - Placebo||0.182|0.095|<0.0001
71682772|NCT00824382|142883772|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.197|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.154|0.241|||ANCOVA|||Olodaterol 5mcg - Placebo||0.241|0.154|<0.0001
71866823|NCT05126563|143249934|SUPERIORITY||LS Means|-0.172|STANDARD_ERROR_OF_MEAN|0.685||0.8021|TWO_SIDED|95.0|-1.54|1.2|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.20|-1.54|0.8021
71866824|NCT05126563|143249935|SUPERIORITY||LS Means|0.399|STANDARD_ERROR_OF_MEAN|0.515||0.4417|TWO_SIDED|95.0|-0.63|1.43|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms. - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.43|-0.63|0.4417
71911658|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190.|PYAR|720.9|||||TWO_SIDED|95.0|718.355|723.435|||negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||723.435|718.355|
71911659|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|929.844|||||TWO_SIDED|95.0|928.755|930.923|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||930.923|928.755|
71911660|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|953.025|||||TWO_SIDED|95.0|951.77|954.257|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||954.257|951.770|
71911661|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181.|PYAR|804.703|||||TWO_SIDED|95.0|803.017|806.38|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||806.380|803.017|
71682773|NCT00824382|142883772|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.193|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001||95.0|0.15|0.236|||ANCOVA|||Olodaterol 10mcg - Placebo||0.236|0.150|<0.0001
71682774|NCT00824382|142883773|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.146|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.101|0.191|||ANCOVA|||Olodaterol 2mcg - Placebo||0.191|0.101|<0.0001
71866825|NCT05126563|143249936|SUPERIORITY||Slope|0.542|STANDARD_ERROR_OF_MEAN|0.721||0.455|TWO_SIDED|95.0|-0.9|1.98|||ANCOVA|||The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.98|-0.90|0.4550
71682775|NCT00824382|142883773|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.202|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.157|0.247|||ANCOVA|||Olodaterol 5mcg - Placebo||0.247|0.157|<0.0001
71866826|NCT05126563|143249937|SUPERIORITY||LS Means|-0.047|STANDARD_ERROR_OF_MEAN|0.466||0.92|TWO_SIDED|95.0|-0.98|0.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.89|-0.98|0.9200
71682776|NCT00824382|142883773|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.196|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.151|0.24|||ANCOVA|||Olodaterol 10mcg - Placebo||0.240|0.151|<0.0001
71866827|NCT05126563|143249938|SUPERIORITY||LS Means|-0.16|STANDARD_ERROR_OF_MEAN|0.36||0.6589|TWO_SIDED|95.0|-0.88|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-0.88|0.6589
71866828|NCT05126563|143249939|SUPERIORITY||LS Means|0.162|STANDARD_ERROR_OF_MEAN|0.725||0.824|TWO_SIDED|95.0|-1.29|1.61|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms Extreme Fatigue scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.61|-1.29|0.8240
71866829|NCT05126563|143249940|SUPERIORITY||LS Means|-0.009|STANDARD_ERROR_OF_MEAN|0.686||0.9892|TWO_SIDED|95.0|-1.38|1.36|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Brain Fog scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.36|-1.38|0.9892
71866830|NCT05126563|143249941|SUPERIORITY||LS Means|0.439|STANDARD_ERROR_OF_MEAN|0.513||0.3952|TWO_SIDED|95.0|-0.59|1.47|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Headache scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.47|-0.59|0.3952
71866831|NCT05126563|143249942|SUPERIORITY||LS Means|0.535|STANDARD_ERROR_OF_MEAN|0.704||0.4504|TWO_SIDED|95.0|-0.87|1.94|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Sleep Disturbances scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.87|0.4504
71866832|NCT05126563|143249943|SUPERIORITY||LS Means|-0.161|STANDARD_ERROR_OF_MEAN|0.469||0.7318|TWO_SIDED|95.0|-1.1|0.78|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Taste scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.78|-1.10|0.7318
71866833|NCT05126563|143249944|SUPERIORITY||LS Means|-0.215|STANDARD_ERROR_OF_MEAN|0.357||0.5485|TWO_SIDED|95.0|-0.93|0.5|||RMA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Neurological Symptoms - Loss of Smell scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.50|-0.93|0.5485
71866834|NCT05126563|143249975|SUPERIORITY||LS Means|-0.377|STANDARD_ERROR_OF_MEAN|0.407||0.3577|TWO_SIDED|95.0|-1.19|0.44|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea at rest scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.44|-1.19|0.3577
71866835|NCT05126563|143249976|SUPERIORITY||LS Means|-0.203|STANDARD_ERROR_OF_MEAN|0.563||0.7196|TWO_SIDED|95.0|-1.33|0.92|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Dyspnea during activity scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.92|-1.33|0.7196
71866836|NCT05126563|143249977|SUPERIORITY||LS Means|-0.306|STANDARD_ERROR_OF_MEAN|0.435||0.4847|TWO_SIDED|95.0|-1.18|0.56|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Cough scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||0.56|-1.18|0.4847
71866837|NCT05126563|143249978|SUPERIORITY||LS Means|0.619|STANDARD_ERROR_OF_MEAN|0.661||0.3535|TWO_SIDED|95.0|-0.71|1.94|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Body aches scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.94|-0.71|0.3535
71866838|NCT05126563|143249979|SUPERIORITY||LS Means|0.472|STANDARD_ERROR_OF_MEAN|0.655||0.4746|TWO_SIDED|95.0|-0.84|1.78|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Visual Analog Scale of Non-Neurological Symptoms. - Joint Pain scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||1.78|-0.84|0.4746
71866839|NCT05126563|143249980|SUPERIORITY||LS Means|-1.433|STANDARD_ERROR_OF_MEAN|2.141||0.5059|TWO_SIDED|95.0|-5.72|2.85|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in Subject's energy - Fatigue Assessment form scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.85|-5.72|0.5059
71866840|NCT05126563|143249981|SUPERIORITY||LS Means|-6.095|STANDARD_ERROR_OF_MEAN|4.99||0.2269|TWO_SIDED|95.0|-16.08|3.89|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups.|The null hypothesis is that the difference in change from baseline to Weeks 26 in Short Form 36 Health Survey Questionnaire (General Health) between treatment groups (HB-adMSCs - Placebo) is equal to zero.||3.89|-16.08|0.2269
71866841|NCT05126563|143249982|SUPERIORITY||LS Means|-0.122|STANDARD_ERROR_OF_MEAN|1.392||0.8735|TWO_SIDED|95.0|-2.91|2.66|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||2.66|-2.91|0.8735
71682777|NCT00824382|142883774|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.107|0.275|||ANCOVA|||Olodaterol 2mcg - Placebo||0.275|0.107|<0.0001
71682778|NCT00824382|142883774|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.191|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001||95.0|0.106|0.276|||ANCOVA|||Olodaterol 5mcg - Placebo||0.276|0.106|<0.0001
71866842|NCT05126563|143249983|SUPERIORITY||LS Means|-3.424|STANDARD_ERROR_OF_MEAN|4.82||0.4802|TWO_SIDED|95.0|-13.07|6.22|||ANCOVA||The value described represents the difference value of the mean change from baseline between HB-adMSC and Placebo groups|The null hypothesis is that the difference in change from baseline to Weeks 26 in PHQ-9 scale score between treatment groups (HB-adMSCs - Placebo) is equal to zero.||6.22|-13.07|0.4802
71866843|NCT06612255|143249984|OTHER|Ratio (%) of adjusted geometric means with comparison presented as test (powder)/reference (tablet).|Fixed Effect Analysis|51.68|||||TWO_SIDED|90.0|45.71|58.43||||||Results obtained from mixed effects model of natural log transformed pharmacokinetic parameters including terms for regimen, period and sequence fitted as fixed effects and subject nested within sequence fitted as a random effect.||58.43|45.71|
71866844|NCT03691909|143250003|OTHER|||||||0.743|||||||Wilcoxon-signed rank test|Effect Size: 0.09||||||0.743
71866845|NCT03691909|143250004|OTHER|||||||0.714|||||||Wilcoxon-signed rank test|Effect Size: 0.10||||||0.714
71866846|NCT03691909|143250005|OTHER|||||||0.183|||||||Wilcoxon-signed rank test|Effect Size: 0.37||||||0.183
71866847|NCT03691909|143250006|OTHER|||||||0.775|||||||Wilcoxon-signed rank test|Effect Size: 0.05||||||0.775
71866848|NCT03691909|143250007|OTHER|||||||0.0008|||||||Wilcoxon-signed rank test|Effect Size: 0.93||Tender Joint Count||||0.0008
71866849|NCT03691909|143250007|OTHER|||||||0.003|||||||Wilcoxon-signed rank test|Effect Size: 0.83||Swollen Joint Count||||0.003
71866850|NCT04150068|143250028|SUPERIORITY|The difference in percentage between 2 treatment groups was compared using an unconditional exact method using 2 invert 1-sided tests with an alpha level at 0.05 to evaluate superiority.|Percentage Difference|70.8|||<|0.0001|TWO_SIDED|95.0|34.9|90.0||The P value and 95% confidence interval (CI) for the point estimate of treatment difference in proportions was estimated and constructed using the Chan and Zhang method.|Chan & Zhang method|||||90.0|34.9|< 0.0001
71866851|NCT05316701|143250037|SUPERIORITY||Hazard Ratio (HR)|0.26|||<|1e-05|TWO_SIDED|95.0|0.14|0.47|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.47|0.14|<0.00001
71866852|NCT05316701|143250038|SUPERIORITY||Hazard Ratio (HR)|0.19||||2e-05|TWO_SIDED|95.0|0.08|0.43|||Gray's test|||Gray's test was stratified by randomization stratification factors.||0.43|0.08|0.00002
71866853|NCT05316701|143250039|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.11823|TWO_SIDED|95.0|0.2|1.22|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||1.22|0.20|0.11823
71866854|NCT05316701|143250040|SUPERIORITY||Hazard Ratio (HR)|0.37||||3e-05|TWO_SIDED|95.0|0.23|0.6|||Log Rank|||Log-rank test was stratified by randomization stratification factors.||0.60|0.23|0.00003
71866855|NCT04696653|143250041|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
71866856|NCT04696653|143250042|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.2|1.8||||||hypertension||1.8|0.2|
71866857|NCT04696653|143250042|SUPERIORITY||Mean Difference (Net)|1.1|||||TWO_SIDED|95.0|0.0|2.1||||||dyslipidemia||2.1|0.0|
71866858|NCT04696653|143250042|SUPERIORITY||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.1|2.0||||||diabetes||2.0|0.1|
71866859|NCT04696653|143250043|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||Evidenced based practice||0.1|-0.6|
71866860|NCT04696653|143250043|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.1||||||CUSP strategy||0.1|-0.6|
71866861|NCT04696653|143250044|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.6|0.2||||||CUSP strategy||0.2|-0.6|
71866862|NCT04696653|143250044|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||Evidenced based practice||0.1|-0.5|
71866863|NCT04696653|143250045|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.5|0.1||||||evidenced based practice||0.1|-0.5|
71866864|NCT04696653|143250045|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.5|0.2||||||CUSP strategy||0.2|-0.5|
71866865|NCT04696653|143250046|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.9|2.2||||||||2.2|0.9|
71866866|NCT04696653|143250047|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.1|1.9||||||||1.9|1.1|
71866867|NCT04696653|143250048|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.7|1.4||||||||1.4|0.7|
71866868|NCT04696653|143250049|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
71866869|NCT04696653|143250054|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|1.0|1.6||||||||1.6|1.0|
71866870|NCT04696653|143250055|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
71866871|NCT04696653|143250056|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
71866872|NCT04696653|143250057|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.1||||||||0.1|-0.2|
71866873|NCT04696653|143250058|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
71866874|NCT04696653|143250059|SUPERIORITY||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
71866875|NCT04696653|143250060|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.3|0.0||||||||0.0|-0.3|
71866876|NCT04696653|143250061|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
71866877|NCT04696653|143250062|SUPERIORITY||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.2||||||||0.2|-0.1|
71866878|NCT04696653|143250063|SUPERIORITY||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.2|0.2||||||||0.2|-0.2|
71866879|NCT04696653|143250064|SUPERIORITY||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.4|0.0||||||||0.0|-0.4|
71866880|NCT04696653|143250065|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.0|3.3||||||||3.3|1.0|
71866881|NCT04679935|143250076|OTHER|Analysis was purely descriptive.|Difference|-3.74|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|95.0|-7.47|-0.01|||MMRM model|||Week 40||-0.01|-7.47|
71866882|NCT04679935|143250076|OTHER|Analysis was purely descriptive.|Difference|-4.15|STANDARD_ERROR_OF_MEAN|2.3|||TWO_SIDED|95.0|-8.78|-0.48|||MMRM model|||Week 44||-0.48|-8.78|
71866883|NCT04679935|143250076|OTHER|Analysis was purely descriptive.|Difference|-5.35|STANDARD_ERROR_OF_MEAN|2.38|||TWO_SIDED|95.0|-10.13|-0.58|||MMRM model|||Week 48||-0.58|-10.13|
71866884|NCT04679935|143250076|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|0.39|||MMRM model|||Week 52||0.39|-8.77|
71866885|NCT04679935|143250076|OTHER|Analysis was purely descriptive.|Difference|-4.36|STANDARD_ERROR_OF_MEAN|2.09|||TWO_SIDED|95.0|-8.56|-0.16|||MMRM model|||Mean of Week 40 to Week 52||-0.16|-8.56|
71866886|NCT04679935|143250084|OTHER|Analysis was purely descriptive.|Difference|-4.19|STANDARD_ERROR_OF_MEAN|2.28|||TWO_SIDED|95.0|-8.77|-0.39|||MMRM model|||Week 52||-0.39|-8.77|
71866887|NCT04362189|143250102|SUPERIORITY||Slope|-1.93|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866888|NCT04362189|143250103|SUPERIORITY||Slope|-1.31|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|||||
71866889|NCT04362189|143250104|SUPERIORITY||Slope|1.36|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866890|NCT04362189|143250105|SUPERIORITY||Slope|0.23|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866891|NCT04362189|143250106|SUPERIORITY||Slope|-0.15|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866892|NCT04362189|143250107|SUPERIORITY||Odds Ratio (OR)|0.2|||||TWO_SIDED||||||||HB-adMSCs represents Numerator and Placebo represents Denominator.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866893|NCT04362189|143250114|SUPERIORITY||Slope|-0.17|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866894|NCT04362189|143250115|SUPERIORITY||Slope|0.55|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866895|NCT04362189|143250116|SUPERIORITY||Slope|0.26|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866896|NCT04362189|143250117|SUPERIORITY||Slope|0.81|||||TWO_SIDED||||||||Slope represents beta coefficient for arm \* time interaction.|Analyses relied on Bayesian inference for test of superiority via generalized linear mixed model.||||
71866897|NCT05116540|143250177|SUPERIORITY||Mean Difference (Final Values)|22.121|STANDARD_ERROR_OF_MEAN|4.616||0.0002|TWO_SIDED|95.0|12.282|31.959|||ANCOVA|||||31.959|12.282|0.0002
71866898|NCT05116540|143250178|SUPERIORITY||Mean Difference (Final Values)|15.764|STANDARD_ERROR_OF_MEAN|5.844||0.0166|TWO_SIDED|95.0|3.307|28.221|||ANCOVA|||||28.221|3.307|0.0166
71866899|NCT05116540|143250179|SUPERIORITY||Mean Difference (Final Values)|22.137|STANDARD_DEVIATION|4.962||0.9905|TWO_SIDED|95.0|12.361|32.006|||ANCOVA|||||32.006|12.361|0.9905
71866900|NCT05116540|143250180|SUPERIORITY||Mean Difference (Final Values)|15.747|STANDARD_DEVIATION|6.274||0.8292|TWO_SIDED|95.0|3.329|28.177|||ANCOVA|||||28.177|3.329|0.8292
71866901|NCT05116540|143250181|SUPERIORITY||Mean Difference (Final Values)|-1.554|STANDARD_ERROR_OF_MEAN|0.638||0.0278|TWO_SIDED|95.0|-2.914|-0.195|||ANCOVA|||||-0.195|-2.914|0.0278
71866902|NCT05116540|143250182|SUPERIORITY||Mean Difference (Final Values)|5.453|STANDARD_ERROR_OF_MEAN|2.757||0.0666|TWO_SIDED|95.0|-0.424|11.33|||ANCOVA|||||11.330|-0.424|0.0666
71866903|NCT05116540|143250183|SUPERIORITY||Mean Difference (Final Values)|10.112|STANDARD_ERROR_OF_MEAN|5.508||0.0863|TWO_SIDED|95.0|-1.629|21.853|||ANCOVA|||||21.853|-1.629|0.0863
71682779|NCT00824382|142883774|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.187|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001||95.0|0.103|0.27|||ANCOVA|||Olodaterol 10mcg - Placebo||0.270|0.103|<0.0001
71866904|NCT05116540|143250184|SUPERIORITY||Mean Difference (Final Values)|0.977|STANDARD_ERROR_OF_MEAN|1.633||0.5588|TWO_SIDED|95.0|-2.504|4.457|||ANCOVA|||||4.457|-2.504|0.5588
71866905|NCT05116540|143250185|SUPERIORITY||Mean Difference (Final Values)|-4.593|STANDARD_ERROR_OF_MEAN|1.023||0.0004|TWO_SIDED|95.0|-6.773|-2.413|||ANCOVA|||||-2.413|-6.773|0.0004
71866906|NCT04348435|143250222|SUPERIORITY||Mean Difference (Net)|0.253|STANDARD_ERROR_OF_MEAN|0.49||0.6113|TWO_SIDED|95.0|||||ANCOVA|||||||0.6113
71866907|NCT04348435|143250222|SUPERIORITY||Mean Difference (Net)|-0.434|STANDARD_ERROR_OF_MEAN|0.638||0.5039|TWO_SIDED|95.0|||||ANCOVA|||||||0.5039
71866908|NCT04348435|143250222|SUPERIORITY||Mean Difference (Net)|0.077|STANDARD_ERROR_OF_MEAN|0.555||0.8903|TWO_SIDED|95.0|||||ANCOVA|||||||0.8903
71866909|NCT04348435|143250223|SUPERIORITY||Mean Difference (Net)|-0.247|STANDARD_ERROR_OF_MEAN|1.056||0.8171|TWO_SIDED|95.0|||||ANCOVA|||||||0.8171
71866910|NCT04348435|143250223|SUPERIORITY||Mean Difference (Net)|-0.913|STANDARD_ERROR_OF_MEAN|1.342||0.5034|TWO_SIDED|95.0|||||ANCOVA|||||||0.5034
71866911|NCT04348435|143250223|SUPERIORITY||Mean Difference (Net)|0.008|STANDARD_ERROR_OF_MEAN|1.193||0.9948|TWO_SIDED|95.0|||||ANCOVA|||||||0.9948
71866912|NCT04348435|143250224|SUPERIORITY||Mean Difference (Net)|0.179|STANDARD_ERROR_OF_MEAN|0.156||0.2641|TWO_SIDED|95.0|||||ANCOVA|||||||0.2641
71866913|NCT04348435|143250224|SUPERIORITY||Mean Difference (Net)|-0.045|STANDARD_ERROR_OF_MEAN|0.198||0.822|TWO_SIDED|95.0|||||ANCOVA|||||||0.8220
71866914|NCT04348435|143250224|SUPERIORITY||Median Difference (Net)|0.178|STANDARD_ERROR_OF_MEAN|0.171||0.3097|TWO_SIDED|95.0|||||ANCOVA|||||||0.3097
71866915|NCT04348435|143250225|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.07||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
71866916|NCT04348435|143250225|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.087||1|TWO_SIDED|95.0|||||ANCOVA|||||||1.000
71866917|NCT04348435|143250225|SUPERIORITY||Mean Difference (Net)|0.112|STANDARD_ERROR_OF_MEAN|0.079||0.1713|TWO_SIDED|95.0|||||ANCOVA|||||||0.1713
71866918|NCT04348435|143250226|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.091||0.3868|TWO_SIDED|95.0|||||ANCOVA|||||||0.3868
71866919|NCT04348435|143250226|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.115||0.9429|TWO_SIDED|95.0|||||ANCOVA|||||||0.9429
71866920|NCT04348435|143250226|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|0.103||0.9362|TWO_SIDED|95.0|||||ANCOVA|||||||0.9362
71866921|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|-0.708|STANDARD_ERROR_OF_MEAN|8.38||0.9333|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.9333
71866922|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|8.78|STANDARD_ERROR_OF_MEAN|9.483||0.3627|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.3627
71866923|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|6.282|STANDARD_ERROR_OF_MEAN|7.604||0.416|TWO_SIDED|95.0|||||ANCOVA|||Average Energy/Fatigue - Treatment Contrast||||0.4160
71866924|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.32||0.8768|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.8768
71866925|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|-7.719|STANDARD_ERROR_OF_MEAN|4.344||0.0869|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.0869
71866926|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|1.434|STANDARD_ERROR_OF_MEAN|3.514||0.6864|TWO_SIDED|95.0|||||ANCOVA|||Average Social Functioning - Treatment Contrast||||0.6864
71866927|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|-4.12|STANDARD_ERROR_OF_MEAN|3.571||0.2587|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.2587
71866928|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|8.417|STANDARD_ERROR_OF_MEAN|5.316||0.125|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.1250
71866929|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|-0.104|STANDARD_ERROR_OF_MEAN|3.732||0.978|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Physical Health - Treatment Contrast||||0.9780
71866930|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|0.963|STANDARD_ERROR_OF_MEAN|5.925||0.8721|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.8721
71866931|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|3.34|STANDARD_ERROR_OF_MEAN|7.735||0.6694|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.6694
71866932|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|5.498|STANDARD_ERROR_OF_MEAN|6.073||0.3733|TWO_SIDED|95.0|||||ANCOVA|||Average General Health - Treatment Contrast||||0.3733
71866933|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|2.433|STANDARD_ERROR_OF_MEAN|4.116||0.5594|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.5594
71866934|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|6.878|STANDARD_ERROR_OF_MEAN|5.389||0.2127|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.2127
71866935|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|3.67|STANDARD_ERROR_OF_MEAN|4.303||0.4012|TWO_SIDED|95.0|||||ANCOVA|||Average Physical Functioning - Treatment Contrast||||0.4012
71866936|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|11.678|STANDARD_ERROR_OF_MEAN|5.748||0.0521|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0521
71866937|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|5.635|STANDARD_ERROR_OF_MEAN|7.696||0.4704|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.4704
71866938|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|12.101|STANDARD_ERROR_OF_MEAN|6.017||0.0544|TWO_SIDED|95.0|||||ANCOVA|||Average Pain - Treatment Contrast||||0.0544
71866939|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|2.333|STANDARD_ERROR_OF_MEAN|3.888||0.5535|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5535
71866940|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|3.689|STANDARD_ERROR_OF_MEAN|4.969||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.4642
71866941|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|2.268|STANDARD_ERROR_OF_MEAN|3.936||0.5692|TWO_SIDED|95.0|||||ANCOVA|||Average Emotional Well Being - Treatment Contrast||||0.5692
71866942|NCT04348435|143250227|SUPERIORITY||Median Difference (Net)|2.667|STANDARD_ERROR_OF_MEAN|3.592||0.4642|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||0.4642
71866943|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|4.444||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
71866944|NCT04348435|143250227|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|3.526||1|TWO_SIDED|95.0|||||ANCOVA|||Avg. Role Limitations Due to Emotional Problems - Treatment Contrast||||1.0000
71866945|NCT04348435|143250228|SUPERIORITY||Mean Difference (Net)|-0.144|STANDARD_ERROR_OF_MEAN|0.825||0.8628|TWO_SIDED|95.0|||||ANCOVA|||||||0.8628
71866946|NCT04348435|143250228|SUPERIORITY||Mean Difference (Net)|-0.605|STANDARD_ERROR_OF_MEAN|0.94||0.5257|TWO_SIDED|95.0|||||ANCOVA|||||||0.5257
71866947|NCT04348435|143250228|SUPERIORITY||Mean Difference (Net)|-0.403|STANDARD_ERROR_OF_MEAN|0.659||0.5467|TWO_SIDED|95.0|||||ANCOVA|||||||0.5467
71866948|NCT01982448|143250275|SUPERIORITY||Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|0.39|23.68|||||Association between HRD status and pathologic response was measured by the odds ratio (OR).|In the Cisplatin treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 52% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 5.7.||23.68|0.39|
71866949|NCT01982448|143250275|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.19|4.95||||||In the Paclitaxel treated patients, the relationship between HRD status and pathologic response was conducted by arm using a univariate logistic regression model and a likelihood ratio test with a one-sided type I error of alpha 0.05. Assuming 12.5% unevaluable, prevalence of HR deficiency 60%, 70 evaluable patients per in a given arm, there is \~80% power to detect a response rate of 37% in HR-deficient patients vs a 16% in HR non-deficient patients, corresponding to the Odds Ratio 0.62.||4.95|0.19|
71866950|NCT01982448|143250276|SUPERIORITY||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.23|118.07||||||||118.07|0.23|
71866951|NCT01982448|143250276|SUPERIORITY||Odds Ratio (OR)|0.55|||||TWO_SIDED|95.0|0.09|4.14||||||||4.14|0.09|
71866952|NCT02898077|143250282|SUPERIORITY||Hazard Ratio (HR)|0.765||||0.0184|TWO_SIDED|95.0|0.613|0.955|||Log Rank|||||0.955|0.613|0.0184
71866953|NCT02898077|143250283|SUPERIORITY||Hazard Ratio (HR)|0.963|||||TWO_SIDED|95.0|0.771|1.203||||||||1.203|0.771|
71866954|NCT02898077|143250284|SUPERIORITY||Hazard Ratio (HR)|0.761|||||TWO_SIDED|95.0|0.598|0.968||||||||0.968|0.598|
71866955|NCT02898077|143250285|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.5|1.2||||||||1.2|0.5|
71866956|NCT02898077|143250286|SUPERIORITY||Hazard Ratio (HR)|0.905|||||TWO_SIDED|95.0|0.577|1.421||||||||1.421|0.577|
71866957|NCT04410523|143250294|SUPERIORITY||Least Squares mean|0.122|STANDARD_ERROR_OF_MEAN|0.0541||0.025|TWO_SIDED|95.0|0.016|0.229|||MMRM||Treatment difference (CSJ117-placebo)|||0.229|0.016|0.025
71866958|NCT04410523|143250294|SUPERIORITY||Least Squares mean|0.058|STANDARD_ERROR_OF_MEAN|0.0542||0.286|TWO_SIDED|95.0|-0.049|0.165|||MMRM||Treatment difference (CCSJ117-placebo)|||0.165|-0.049|0.286
71866959|NCT04410523|143250294|SUPERIORITY||Least Squares mean|0.065|STANDARD_ERROR_OF_MEAN|0.0521||0.212|TWO_SIDED|95.0|-0.037|0.168|||MMRM||Treatment difference (CCSJ117-placebo)|||0.168|-0.037|0.212
71866960|NCT04410523|143250294|SUPERIORITY||Least Squares mean|0.009|STANDARD_ERROR_OF_MEAN|0.043||0.831|TWO_SIDED|95.0|-0.076|0.094|||MMRM||Treatment difference (CCSJ117-placebo)|||0.094|-0.076|0.831
71866961|NCT04410523|143250294|SUPERIORITY||Least Squares mean|-0.008|STANDARD_ERROR_OF_MEAN|0.0434||0.852|TWO_SIDED|95.0|-0.094|0.077|||MMRM||Treatment difference (CCSJ117-placebo)|||0.077|-0.094|0.852
71866962|NCT04410523|143250295|SUPERIORITY||Least Squares mean|-1.568|STANDARD_ERROR_OF_MEAN|2.363||0.508|TWO_SIDED|95.0|-6.219|3.083|||MMRM||Treatment difference (CSJ117-placebo)|||3.083|-6.219|0.508
71866963|NCT04410523|143250295|SUPERIORITY||Least Squares mean|-3.998|STANDARD_ERROR_OF_MEAN|2.384||0.095|TWO_SIDED|95.0|-8.691|0.695|||MMRM||Treatment difference (CCSJ117-placebo)|||0.695|-8.691|0.095
71866964|NCT04410523|143250295|SUPERIORITY||Least Squares mean|-2.889|STANDARD_ERROR_OF_MEAN|2.2943||0.209|TWO_SIDED|95.0|-7.405|1.627|||MMRM||Treatment difference (CCSJ117-placebo)|||1.627|-7.405|0.209
71866965|NCT04410523|143250295|SUPERIORITY||Least Squares mean|-0.287|STANDARD_ERROR_OF_MEAN|1.8718||0.878|TWO_SIDED|95.0|-3.971|3.398|||MMRM||Treatment difference (CCSJ117-placebo)|||3.398|-3.971|0.878
71866966|NCT04410523|143250295|SUPERIORITY||Least Squares mean|1.093|STANDARD_ERROR_OF_MEAN|1.8652||0.558|TWO_SIDED|95.0|-2.578|4.765|||MMRM||Treatment difference (CCSJ117-placebo)|||4.765|-2.578|0.558
71866967|NCT04410523|143250298|SUPERIORITY||Least Squares mean|-0.042|STANDARD_ERROR_OF_MEAN|0.1493||0.78|TWO_SIDED|95.0|-0.336|0.252|||MMRM||Treatment difference (CSJ117-placebo)|||0.252|-0.336|0.780
71866968|NCT04410523|143250298|SUPERIORITY||Least Squares mean|-0.42|STANDARD_ERROR_OF_MEAN|0.1489||0.005|TWO_SIDED|95.0|-0.713|-0.127|||MMRM||Treatment difference (CCSJ117-placebo)|||-0.127|-0.713|0.005
71866969|NCT04410523|143250298|SUPERIORITY||Least Squares mean|-0.289|STANDARD_ERROR_OF_MEAN|0.1446||0.047|TWO_SIDED|95.0|-0.573|0.004|||MMRM||Treatment difference (CCSJ117-placebo)|||0.004|-0.573|0.047
71866970|NCT04410523|143250298|SUPERIORITY||Least Squares mean|-0.017|STANDARD_ERROR_OF_MEAN|0.1182||0.887|TWO_SIDED|95.0|-0.249|0.216|||MMRM||Treatment difference (CCSJ117-placebo)|||0.216|-0.249|0.887
71866971|NCT04410523|143250298|SUPERIORITY||Least Squares mean|-0.115|STANDARD_ERROR_OF_MEAN|0.1184||0.333|TWO_SIDED|95.0|-0.348|0.118|||MMRM||Treatment difference (CCSJ117-placebo)|||0.118|-0.348|0.333
71866972|NCT04410523|143250299|SUPERIORITY||Least Squares mean|-0.097|STANDARD_ERROR_OF_MEAN|0.1485||0.515|TWO_SIDED|95.0|-0.389|0.195|||MMRM||Treatment difference (CSJ117-placebo)|||0.195|-0.389|0.515
71866973|NCT04410523|143250299|SUPERIORITY||Least Squares mean|0.218|STANDARD_ERROR_OF_MEAN|0.1484||0.143|TWO_SIDED|95.0|-0.074|0.51|||MMRM||Treatment difference (CCSJ117-placebo)|||0.510|-0.074|0.143
71866974|NCT04410523|143250299|SUPERIORITY||Least Squares mean|0.078|STANDARD_ERROR_OF_MEAN|0.145||0.59|TWO_SIDED|95.0|-0.207|0.364|||MMRM||Treatment difference (CCSJ117-placebo)|||0.364|-0.207|0.590
71866975|NCT04410523|143250299|SUPERIORITY||Least Squares mean|0.033|STANDARD_ERROR_OF_MEAN|0.118||0.778|TWO_SIDED|95.0|-0.199|0.265|||MMRM||Treatment difference (CCSJ117-placebo)|||0.265|-0.199|0.778
71866976|NCT04410523|143250299|SUPERIORITY||Least Squares mean|0.073|STANDARD_ERROR_OF_MEAN|0.118||0.539|TWO_SIDED|95.0|-0.16|0.305|||MMRM||Treatment difference (CCSJ117-placebo)|||0.305|-0.160|0.539
71866977|NCT03651622|143250374|SUPERIORITY|||||||0.98|||||||ANOVA|||||||0.98
71866978|NCT03651622|143250375|SUPERIORITY|||||||0.85|||||||ANOVA|||||||0.85
71866979|NCT03651622|143250376|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.40
71866980|NCT03651622|143250377|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.02
71866981|NCT03651622|143250378|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
71866982|NCT03651622|143250379|SUPERIORITY|||||||0.18|||||||ANOVA|||||||0.18
71866983|NCT03651622|143250380|SUPERIORITY|||||||0.79|||||||ANOVA|||||||0.79
71866984|NCT03651622|143250381|SUPERIORITY|||||||0.39|||||||ANOVA|||The proposed sample size of n=72 was sufficient to ensure 60% power to detect a moderate effect size (Cohen h=0.68) and 80% to detect a large effect size (Cohen h=0.85) at a significance level of 0.10 for comparing difference in change among the 3 diets. By design, our primary goal for this pilot work is to inform the final efficacy design of a fully powered SMART, and the pilot SMART was therefore not designed to be fully powered for all analyses.||||0.39
71866985|NCT03651622|143250382|SUPERIORITY|||||||0.75|||||||ANOVA|||||||0.75
71866986|NCT03651622|143250383|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
71866987|NCT03651622|143250384|SUPERIORITY|||||||0.96|||||||ANOVA|||||||0.96
71866988|NCT03651622|143250385|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.34
71866989|NCT03651622|143250386|SUPERIORITY|||||||0.58|||||||ANOVA|||||||0.58
71866990|NCT03651622|143250387|SUPERIORITY|||||||0.95|||||||ANOVA|||||||0.95
71866991|NCT03651622|143250388|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
71866992|NCT00127205|143250427|OTHER|||||||0.49|||||||Log Rank|||||||0.49
71866993|NCT00127205|143250427|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.24|TWO_SIDED|95.0|0.94|1.26|||Regression, Cox|||||1.26|0.94|0.24
71866994|NCT00127205|143250427|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5|TWO_SIDED|95.0|0.9|1.24|||Regression, Cox|||||1.24|0.90|0.50
71866995|NCT00127205|143250428|OTHER|||||||0.5|||||||Log Rank|||||||0.50
71866996|NCT00127205|143250429|OTHER|||||||0.93|||||||Log Rank|||Statistical analysis for recurrence to bone||||0.93
71866997|NCT00307684|143250442|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.89||||0.2586||95.0|-2.2055|7.9774||No adjustment for multiplicity was performed. threshold for significance: 0.05 (2-sided)|ANCOVA|treatment, sex and country as factors, age and baseline sum of inattention and hyperactivity/impulsivity scores as covariate||Based on preliminary results of a controlled study in adults with MPH, the mean (SD=9) change in CAARS total score from randomization to the 4 week post-randomization endpoint was estimated as +2.5 for PR OROS MPH and +14 for placebo. slightly more conservative, a mean change of 3 in the PR OROS MPH group and a mean increase of 10 in the placebo group were expected. With a two-sided type-I error of 5% and a power of 90%, 37 eligible subjects per group were required.||7.9774|-2.2055|0.2586
71866998|NCT00307684|143250445|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3942||||0.2616||95.0|-12.1928|3.4044||No adjustment for multiplicity was performed.|ANCOVA|ANCOVA on the ranks with sex, treatment and country as factors and age and baseline score as a covariate||||3.4044|-12.1928|0.2616
71866999|NCT00307684|143250446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.5458||95.0|-5.5469|10.3213|||ANCOVA|treatment and country as factors baseline score as covariate||||10.3213|-5.5469|0.5458
71682780|NCT00824382|142883775|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.16|0.345|||ANCOVA|||Olodaterol 2mcg - Placebo||0.345|0.160|<0.0001
71911662|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060.|PYAR|818.66|||||TWO_SIDED|95.0|816.391|820.912|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||820.912|816.391|
71911663|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|916.079|||||TWO_SIDED|95.0|914.891|917.256|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||917.256|914.891|
71911664|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|928.568|||||TWO_SIDED|95.0|927.038|930.076|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||930.076|927.038|
71911665|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914.|PYAR|796.894||||||95.0|795.175|798.605|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||798.605|795.175|
71911666|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071.|PYAR|803.918|||||TWO_SIDED|95.0|801.571|806.25|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||806.250|801.571|
71911667|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|865.679|||||TWO_SIDED|95.0|864.227|867.121|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||867.121|864.227|
71682781|NCT00824382|142883775|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.25|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.156|0.343|||ANCOVA|||Olodaterol 5mcg - Placebo||0.343|0.156|<0.0001
71867000|NCT03377699|143250447|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.11|||<|0.0001|TWO_SIDED|95.0|-0.31|0.08|||ANCOVA|||Primary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.08|-0.31|<0.0001
71867001|NCT03377699|143250447|EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI for mean treatment difference in HbA1c is strictly below 0.4%.|Mean treatment difference|-0.08||||0.3881|TWO_SIDED|95.0|-0.27|0.11|||ANCOVA|||Secondary Estimand. Imputation of missing data was done within two groups of participants defined by randomised treatment arm based on a multiple imputation approach (x1000). For each of the 1000 imputed datasets last planned HbA1c prior to delivery after GW 16 was analysed using an ANCOVA with treatment, region and the stratification factor as categorical fixed effects and a pregnancy status at randomisation-by-baseline HbA1c interaction.||0.11|-0.27|0.3881
71867002|NCT02580305|143250471|SUPERIORITY|||||||0.41||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.41
71867003|NCT02580305|143250471|SUPERIORITY|||||||0.9||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.90
71867004|NCT02580305|143250472|SUPERIORITY|||||||0.46||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.46
71682782|NCT00824382|142883775|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.233|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001||95.0|0.141|0.325|||ANCOVA|||Olodaterol 10mcg - Placebo||0.325|0.141|<0.0001
71867005|NCT02580305|143250472|SUPERIORITY|||||||0.48||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.48
71867006|NCT02580305|143250473|SUPERIORITY|||||||0.83||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.83
71867007|NCT02580305|143250473|SUPERIORITY|||||||0.24||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.24
71867008|NCT02580305|143250474|SUPERIORITY|||||||0.17||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.17
71682783|NCT00824382|142883776|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.253|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.155|0.351|||ANCOVA|||Olodaterol 2mcg - Placebo||0.351|0.155|<0.0001
71867009|NCT02580305|143250474|SUPERIORITY|||||||0.14||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.14
71867010|NCT02580305|143250475|SUPERIORITY|||||||0.79||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.79
71867011|NCT02580305|143250475|SUPERIORITY|||||||0.92||||||Threshold for statistical significance was p≤0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures||||||0.92
71867012|NCT03582943|143250490|SUPERIORITY|A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.|Mean Difference (Net)|0.74||||0.984|TWO_SIDED|||||Test of differences between groups.|Mixed Models Analysis|||||||0.984
71867013|NCT03582943|143250490|SUPERIORITY||Mean Difference (Net)|-0.023||||0.455|TWO_SIDED|||||Test of interaction between age and RLIC vs. sham|Mixed Models Analysis|||||||.455
71867014|NCT03582943|143250490|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.803|TWO_SIDED|||||Test of interaction between sex and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.803
71867015|NCT03582943|143250490|SUPERIORITY||Mean Difference (Net)|0.25||||0.233|TWO_SIDED|||||Test of interaction between BMI and RLIC vs. sham conditioning|Mixed Models Analysis|||||||0.233
71867016|NCT03582943|143250490|SUPERIORITY|Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning|Mean Difference (Net)|4.12||||0.29|TWO_SIDED||||||Mixed Models Analysis|||||||0.29
71867017|NCT05032872|143250491|SUPERIORITY|||||||0.49||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time by condition interaction||||.49
71867018|NCT05032872|143250492|SUPERIORITY|||||||0.48||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.48
71867019|NCT05032872|143250493|SUPERIORITY|||||||0.04||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quality||||.04
71867020|NCT05032872|143250493|SUPERIORITY|||||||0.44||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting dissatisfaction with contact quantity||||.44
71867021|NCT05032872|143250493|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting satisfaction with contact quantity||||.99
71867022|NCT05032872|143250493|SUPERIORITY|||||||0.87||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting knowing others' experience||||.87
71867023|NCT05032872|143250493|SUPERIORITY|||||||0.98||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting shared understanding||||.98
71867024|NCT05032872|143250493|SUPERIORITY|||||||0.76||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relationship salience||||.76
71867025|NCT05032872|143250494|SUPERIORITY|||||||0.29||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.29
71867026|NCT05032872|143250495|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting positive affect||||.51
71867027|NCT05032872|143250495|SUPERIORITY|||||||0.83||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition predicting negative affect||||.83
71867028|NCT05032872|143250496|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.51
71867029|NCT05032872|143250497|SUPERIORITY|||||||0.65||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.65
71867030|NCT05032872|143250498|SUPERIORITY|||||||0.01||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of distress||||.01
71867031|NCT05032872|143250498|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||time x condition interaction predicting caregiver overload||||.75
71867032|NCT05032872|143250498|SUPERIORITY|||||||0.59||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting relational deprivation||||.59
71867033|NCT05032872|143250498|SUPERIORITY|||||||0.51||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting job caregiving conflict||||.51
71867034|NCT05032872|143250498|SUPERIORITY|||||||0.25||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting role captivity||||.25
71867035|NCT05032872|143250498|SUPERIORITY|||||||0.34||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting sense of self||||.34
71867036|NCT05032872|143250498|SUPERIORITY|||||||0.75||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting personal gain||||.75
71867037|NCT05032872|143250498|SUPERIORITY|||||||0.99||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting caregiving competence||||.99
71867038|NCT05032872|143250498|SUPERIORITY|||||||0.61||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of situition||||.61
71867039|NCT05032872|143250498|SUPERIORITY|||||||0.92||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting management of meaning||||.92
71867040|NCT05032872|143250498|SUPERIORITY|||||||0.96||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction predicting expressive support||||.96
71867041|NCT05032872|143250499|SUPERIORITY|||||||0.37||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.37
71867042|NCT05032872|143250500|SUPERIORITY|||||||0.89||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.89
71867043|NCT05032872|143250501|SUPERIORITY|||||||0.3||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.30
71867044|NCT05032872|143250502|SUPERIORITY|||||||0.52||||||Controlled for age, sex, education, and self-reported functional health|Mixed Models Analysis|||Time x condition interaction||||.52
71867045|NCT05032872|143250503|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Independent sample T-test comparing the treatment and control group||||.45
71867046|NCT02946853|143250543|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.14|7.21|||Regression, Logistic|||||7.21|0.14|1.00
71867047|NCT02946853|143250544|SUPERIORITY||Mean Difference (Net)|-1.0||||0.974|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.974
71867048|NCT02946853|143250545|SUPERIORITY||Mean Difference (Net)|0.5||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Some patients did not undergo 6 month echocardiogram due to restrictions related to COVID-19.||||1.00
71867049|NCT02946853|143250546|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.1|84.4|||Fisher Exact|||||84.4|0.1|1.00
71867050|NCT02946853|143250547|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED||||||Fisher Exact|||||||1.00
71867051|NCT02946853|143250548|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.00|0.00|1.00
71867052|NCT02946853|143250549|SUPERIORITY||Mean Difference (Final Values)|20.6||||0.005|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.005
71867053|NCT02946853|143250550|SUPERIORITY||Median Difference (Final Values)|23.7||||0.565|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.565
71867054|NCT02946853|143250551|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|42.0|||Fisher Exact|||||42.0|0.0|1.00
71867055|NCT01404429|143250554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14||||0.6|TWO_SIDED|95.0|-0.26|0.54|||t-test, 2 sided|||||0.54|-0.26|0.6
71867056|NCT01163292|143250577|SUPERIORITY_OR_OTHER|||||||0.144||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.144
71867057|NCT01163292|143250577|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.004
71867058|NCT01163292|143250577|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.006
71867059|NCT01163292|143250578|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Fisher Exact|||Week 0||||0.290
71867060|NCT01163292|143250578|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Week 26||||1.000
71867061|NCT01163292|143250578|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||Week 52||||0.001
71867062|NCT01163292|143250579|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Wilcoxon Rank Sum|||||||0.335
71867063|NCT01163292|143250580|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Wilcoxon Rank Sum|||Week 0||||0.266
71867064|NCT01163292|143250580|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||Wilcoxon Rank Sum|||Week 26||||0.440
71867065|NCT01163292|143250580|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||Wilcoxon Rank Sum|||Week 52||||0.609
71867066|NCT02217475|143250589|SUPERIORITY||Odds Ratio (OR)|0.816||||0.5194|TWO_SIDED|95.0|0.439|1.516|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||1.516|0.439|0.5194
71867067|NCT02217475|143250590|SUPERIORITY||Odds Ratio (OR)|1.934||||0.0388|TWO_SIDED|95.0|1.035|3.614|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.614|1.035|0.0388
71867068|NCT02217475|143250591|SUPERIORITY||Odds Ratio (OR)|1.249||||0.592|TWO_SIDED|95.0|0.553|2.821|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.821|0.553|0.5920
71867069|NCT02217475|143250592|SUPERIORITY||Odds Ratio (OR)|1.396||||0.4941|TWO_SIDED|95.0|0.537|3.628|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||3.628|0.537|0.4941
71867070|NCT02217475|143250593|SUPERIORITY||Odds Ratio (OR)|1.142||||0.8434|TWO_SIDED|95.0|0.305|4.277|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.277|0.305|0.8434
71867071|NCT02217475|143250594|SUPERIORITY||Odds Ratio (OR)|2.201||||0.0234|TWO_SIDED|95.0|1.113|4.352|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||4.352|1.113|0.0234
71867072|NCT02217475|143250595|SUPERIORITY||Odds Ratio (OR)|1.154||||0.7474|TWO_SIDED|95.0|0.484|2.752|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.||||2.752|0.484|0.7474
71867073|NCT02643472|143250641|SUPERIORITY|||||||0.73|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.73
71867074|NCT02643472|143250642|SUPERIORITY|||||||0.12|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||STAI Y-1 data was used in these statistical analyses.||||0.12
71867075|NCT02643472|143250643|SUPERIORITY|||||||0.03|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.03
71867076|NCT02643472|143250646|SUPERIORITY|||||||0.06|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||||||0.06
71867077|NCT02643472|143250647|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71867078|NCT02643472|143250648|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71867079|NCT02643472|143250649|SUPERIORITY|||||||0.6|||||||Chi-squared|||||||0.60
71867080|NCT02643472|143250650|SUPERIORITY|||||||0.92|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Cognitive subscale.||||0.92
71867081|NCT02643472|143250650|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Language subscale.||||0.58
71867082|NCT02643472|143250650|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Motor subscale.||||0.87
71867083|NCT00673400|143250689|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Lifestyle (LS)||||0.1340
71867084|NCT00673400|143250689|SUPERIORITY_OR_OTHER|||||||0.088||95.0||||based on 29 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Coping/behavior (C/B)||||0.088
71867085|NCT00673400|143250689|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Depression/self-perception (D/S)||||0.0012
71867086|NCT00673400|143250689|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Embarrassment (E)||||0.0074
71867087|NCT00673400|143250692|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
71867088|NCT00673400|143250692|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
71867089|NCT00673400|143250692|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
71867090|NCT00673400|143250693|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
71911668|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|871.749|||||TWO_SIDED|95.0|869.771|873.707|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||873.707|869.771|
71911669|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913.|PYAR|753.423|||||TWO_SIDED|95.0|751.591|755.249|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).||755.249|751.591|
71911670|NCT00861380|143343784|OTHER|In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414.|PYAR|755.542|||||TWO_SIDED|95.0|753.008|758.064|||Negative Binomial model with strata|Analysis performed on non-vaccinated persons, not enrolled in the study, but living in cluster areas in which study participants received vaccine.||For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).||758.064|753.008|
71911671|NCT00637377|143343796|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.2|||||TWO_SIDED|95.0|-4.86|2.46|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q4).||2.46|-4.86|
71911672|NCT00637377|143343796|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.84|||||TWO_SIDED|95.0|-5.4|1.71|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 0.5mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 0.5mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 0.5mg Q4).||1.71|-5.40|
71682784|NCT00824382|142883776|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.242|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.142|0.341|||ANCOVA|||Olodaterol 5mcg - Placebo||0.341|0.142|<0.0001
71867091|NCT00673400|143250693|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
71867092|NCT00673400|143250693|SUPERIORITY_OR_OTHER||||||<|1e-07||95.0|||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method||||||<0.0000001
71867093|NCT00673400|143250694|SUPERIORITY_OR_OTHER|||||||0.65||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Physical component summary (PCS)||||0.65
71867094|NCT00673400|143250694|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Mental component summary (MCS)||||0.010
71682785|NCT00824382|142883776|SUPERIORITY_OR_OTHER||Least Squares Mean for the difference|0.226|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.129|0.324|||ANCOVA|||Olodaterol 10mcg - Placebo||0.324|0.129|<0.0001
71682786|NCT00824382|142883777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.039||0.0045||95.0|0.035|0.188|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.188|0.035|0.0045
71682787|NCT00824382|142883777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.14|0.293|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.293|0.140|<0.0001
71911673|NCT00637377|143343796|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.13|||||TWO_SIDED|95.0|-4.81|2.55|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q8 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q8, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q8).||2.55|-4.81|
71682788|NCT00824382|142883777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.142|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.292|0.142|<0.0001
71867095|NCT01680640|143250695|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_DEVIATION|0.8|=|0.05|TWO_SIDED|95.0||||The threshold for statistical significance was p=0.05|Regression, Linear|||A total sample size of 100 participants, with a 14% drop out during the study and 43 participants in each group completing the study provided 85% power to detect a difference of 40% in liver fat (in the treatment arm compared with the placebo), using a power calculation test with a 0.05 two-sided significance level. For change in liver fat percentage (and other secondary outcomes), ANCOVA will also be undertaken to assess effect sizes in the intervention group and placebo.||||=0.05
71867096|NCT01680640|143250695|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71867097|NCT01680640|143250696|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end-of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.1||||1|TWO_SIDED||||||Regression, Linear|||||||1.00
71867098|NCT01680640|143250697|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Mean Difference (Final Values)|0.2||||0.8|TWO_SIDED||||||Regression, Linear|||||||0.80
71867099|NCT01680640|143250698|SUPERIORITY|For each primary outcome, a change variable was calculated as the difference between end of study and baseline measurements. Multiple regression analysis was used to assess the effect of synbiotic treatment on each of the change variables of interest.|Median Difference (Final Values)|0.97|||<|0.001|TWO_SIDED||||||Beta-diversity indexes|Beta-diversity indexes were first visualized through a Principal Coordinates Analysis (PCoA)||||||<0.001
71682789|NCT00824382|142883778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.039||0.0348||95.0|0.006|0.159|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.159|0.006|0.0348
71682790|NCT00824382|142883778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.176|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001||95.0|0.1|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||0.252|0.100|<0.0001
71682791|NCT00824382|142883778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001||95.0|0.115|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||0.265|0.115|<0.0001
71682792|NCT00824382|142883779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.256|STANDARD_ERROR_OF_MEAN|5.476|<|0.0001||95.0|16.477|38.036|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||38.036|16.477|<0.0001
71867100|NCT00291642|143250715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|0.64|<|0.001|TWO_SIDED|95.0|-4.61|-2.09|||ANCOVA|||||-2.09|-4.61|<0.001
71867101|NCT00291642|143250715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.25|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.5|-2.0|||ANCOVA|||||-2.00|-4.50|<0.001
71867102|NCT00291642|143250715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.13|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-5.38|-2.88|||ANCOVA|||||-2.88|-5.38|<0.001
71867103|NCT00291642|143250715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.637|<|0.001|TWO_SIDED|95.0|-4.99|-2.49|||ANCOVA|||||-2.49|-4.99|<0.001
71867104|NCT02576587|143250729|OTHER|Conditional logistic regression was used to assess the relationship of PAF and AHI on matched pairs of case and control.|Odds Ratio (OR)|0.98|STANDARD_ERROR_OF_MEAN|0.007||0.054|TWO_SIDED|95.0|0.97|1.0|||Conditional logistic regression|||||1.00|0.97|0.054
71867105|NCT02576587|143250729|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume on matched pairs of case and control.|Odds Ratio (OR)|1.02|STANDARD_ERROR_OF_MEAN|0.007||0.014|TWO_SIDED|95.0|1.0|1.03|||Conditional logistic regression|N = 270 (135 cases and 135 controls)||||1.03|1.00|0.014
71682793|NCT00824382|142883779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.383|STANDARD_ERROR_OF_MEAN|5.574|<|0.0001||95.0|18.41|40.357|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||40.357|18.410|<0.0001
71867106|NCT02576587|143250729|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA volume index on matched pairs of case and control.|Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.015||0.03|TWO_SIDED|95.0|1.0|1.06|||Conditional logistic regression|N=268 (134 cases and 134 controls)||||1.06|1.00|0.030
71867107|NCT02576587|143250729|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical four-chamber (A4C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.39|TWO_SIDED|95.0|0.96|1.01|||Conditional logistic regression|N=214 (107 cases and 107 controls)||||1.01|0.96|0.39
71867108|NCT02576587|143250729|OTHER|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical two-chamber (A2C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|STANDARD_ERROR_OF_MEAN|0.013||0.49|TWO_SIDED|95.0|0.97|1.02|||Conditional logistic regression|N=212 (106 cases and 106 controls)||||1.02|0.97|0.49
71867109|NCT02576587|143250730|OTHER||median of change|3.4||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|||Inter-Quartile Range of the change (post minus pre) is (-7.0, 13.7).|||0.16
71867110|NCT02576587|143250731|OTHER||median of change|1.8||||0.088|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-2.0, 6.0).|||||0.088
71867111|NCT02576587|143250732|OTHER||median of change|-3.7||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-8.0, -0.57).|||||0.006
71867112|NCT02576587|143250733|OTHER||median of change|-0.7||||0.59|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-6.2, 10.7).|||||0.59
71867113|NCT02576587|143250734|OTHER||mean of change|0.62|STANDARD_DEVIATION|4.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
71867114|NCT02576587|143250735|OTHER||mean of change|-1.7|STANDARD_DEVIATION|12.2||0.65|TWO_SIDED||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.||||||0.65
71867115|NCT00738894|143250751|SUPERIORITY|This is the first of two primary outcomes for this study. Assumptions for power calculations: expected event free for medical management 92% at 24 months; expected event free for device closure 96.4% at 24 months (55% risk reduction); 664 subjects randomly assigned 2:1 to device closure or medical management provides 80% power with 15% attrition (over 5 years) and 1-sided alpha = 0.024 to allow for interim analysis (interim analysis later rescinded from plan).|Hazard Ratio (HR)|0.23||||0.001|TWO_SIDED|95.0|0.09|0.62||1-sided p-value was adjusted for multiplicity with 2nd primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|Log Rank||Hazard ratio (test/control) obtained from Cox proportional hazards model with treatment arm as sole explanatory variable, the exponentiated coefficient of which provided the hazard ratio. Unadjusted for multiplicity.|"Test null hypothesis of equal or lower recurrent stroke-free survivorship for device closure compared to medical management.~H0: Sd(t) ≤ Sm(t) for all t, versus H1: Sd(t) \> Sm(t) for all t, where Sd(t) and Sm(t) are true Kaplan-Meier product-limit survivor functions for the device closure and medical management arms and t is time from randomization to event or censoring.~Event-free subjects were censored at time of last follow-up. Significance threshold (1-sided alpha) = 0.025."||0.62|0.09|0.001
71867116|NCT00738894|143250752|SUPERIORITY|This is the second of two primary outcomes for this study. Assumptions for power calculations: expected proportion of brain infarct is 3-7 times the clinical stroke rate; expected brain infarct proportion for medical management 14.5% (2.9% clinical stroke x 5); expected brain infarct for device closure 6.5% (55% risk reduction); 597 subjects (10% attrition from 664) provides 73% power with 1-sided alpha = 0.0125 (based conservatively on a Bonferroni adjustment of alpha/2).|Risk Difference (RD)|0.056||||0.024|TWO_SIDED|95.0|0.003|0.108||1-sided p-value was adjusted for multiplicity with 1st primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|z-test, 1-sided||Unadjusted for multiplicity.|"Test null hypothesis of equal or higher proportion with brain infarct for device closure compared to medical management.~H0: Pm - Pd ≤ 0, versus H1: Pm - Pd \> 0, where Pd and Pm are true proportions of subjects with brain infarct for the device closure and medical management arms.~Significance threshold (1-sided alpha) = 0.025."||0.108|0.003|0.024
71867117|NCT05745701|143250755|OTHER||test/reference ratios|195.9|||||TWO_SIDED|90.0|162.13|236.71||||||Natural loge transformed Cmax of PF-07081532 administered without cyclosporine (Reference) or coadministered with cyclosporine (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||236.71|162.13|
71867118|NCT05745701|143250755|OTHER||test/reference ratios|282.13|||||TWO_SIDED|90.0|258.81|307.55||||||Natural loge transformed Cmax of PF-07081532 administered without itraconazole (Reference) or coadministered with itraconazole (Test) were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. Estimates of the adjusted mean differences (Test/Reference) and corresponding 90% CIs was obtained from the models. The ratios (and 90% CIs) were expressed as percentages.||307.55|258.81|
71867119|NCT00719329|143250768|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.75|||||TWO_SIDED|95.0|0.7|0.81|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Single CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.81|0.70|
71867120|NCT00719329|143250768|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.71|||||TWO_SIDED|95.0|0.66|0.77|||Binomial Regression, Log Link|General Estimating Equations (GEE) to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.77|0.66|
71867121|NCT00719329|143250769|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.78|||||TWO_SIDED|95.0|0.74|0.82|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.82|0.74|
71867122|NCT00719329|143250769|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.61|||||TWO_SIDED|95.0|0.57|0.65|||Binomial Regression, Log Link|Generalized Estimating Equations to account for clustered allocation|Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.65|0.57|
71867123|NCT00719329|143250770|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.92|||||TWO_SIDED|95.0|0.89|0.96|||Binomial Regression, Log Link|General Estimating Equations to adjust for clustered allocation|Prevalence Rate Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.96|0.89|
71867124|NCT00719329|143250770|SUPERIORITY_OR_OTHER||Prevalence Rate Ratio|0.57|||||TWO_SIDED|95.0|0.53|0.63|||Binomial Regression, Log Link|General Estimating Equations to account for clustered allocation|Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group||0.63|0.53|
71867125|NCT00422812|143250808|SUPERIORITY|||||||0.0012||||||Overall effect at 2 hr (by Cochran-Mantel-Haenszel) for TREATMENT|Cochran-Mantel-Haenszel|||||||0.0012
71867126|NCT00422812|143250809|SUPERIORITY|||||||0.281|||||||Fisher Exact|||||||0.281
71867127|NCT00422812|143250809|SUPERIORITY|||||||0.0226|||||||Fisher Exact|||||||0.0226
71867128|NCT00422812|143250809|SUPERIORITY|||||||0.0019|||||||Fisher Exact|||||||0.0019
71867129|NCT00422812|143250810|SUPERIORITY|||||||0.0007||||||Overall effect (0-4 hr) for TREATMENT by Log-rank p-value|Log Rank|There was no adjustment for multiple comparisons.||||||0.0007
71867130|NCT00422812|143250810|SUPERIORITY|||||||0.0008|||||||Log Rank|No adjustments were made for multiple comparisons||||||0.0008
71867131|NCT00422812|143250810|SUPERIORITY|||||||0.0008||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0008
71867132|NCT00422812|143250810|SUPERIORITY|||||||0.0003||||||No adjustments were made for multiple comparisons|Log Rank|||||||0.0003
71867133|NCT01397422|143250811|SUPERIORITY||Least Squares Mean Difference|-11.3||||0.0051|TWO_SIDED|95.0|-19.1|-3.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.||-3.5|-19.1|0.0051
71867134|NCT01397422|143250811|SUPERIORITY||Least Squares Mean Difference|-10.0||||0.0131|TWO_SIDED|95.0|-17.8|-2.2|||ANCOVA|||||-2.2|-17.8|0.0131
71867135|NCT01397422|143250811|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.1595|TWO_SIDED|95.0|-13.4|2.2|||ANCOVA|||||2.2|-13.4|0.1595
71867136|NCT01397422|143250812|SUPERIORITY||Least Squares Mean Difference|-0.3||||0.4314|TWO_SIDED|95.0|-1.1|0.5|||ANCOVA|||||0.5|-1.1|0.4314
71867137|NCT01397422|143250812|SUPERIORITY||Least Squares Mean Difference|0.3||||0.5223|TWO_SIDED|95.0|-0.5|1.0|||ANCOVA|||||1.0|-0.5|0.5223
71867138|NCT01397422|143250812|SUPERIORITY||Least Squares Mean Difference|0.2||||0.6298|TWO_SIDED|95.0|-0.6|1.0|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, baseline value is a covariate||||1.0|-0.6|0.6298
71867139|NCT01397422|143250813|SUPERIORITY||Least Squares Mean Difference|-5.2||||0.0038|TWO_SIDED|95.0|-8.7|-1.7|||ANCOVA|||||-1.7|-8.7|0.0038
71867140|NCT01397422|143250813|SUPERIORITY||Least Squares Mean Difference|-6.4||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||||-2.9|-9.8|0.0004
71867141|NCT01397422|143250813|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.1469|TWO_SIDED|95.0|-6.0|0.9|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||||0.9|-6.0|0.1469
71867142|NCT01397422|143250814|SUPERIORITY||Least Squares Mean Difference|3.0||||0.0078|TWO_SIDED|95.0|0.8|5.2|||ANCOVA|||||5.2|0.8|0.0078
71867143|NCT01397422|143250814|SUPERIORITY||Least Squares Mean Difference|2.7||||0.0179|TWO_SIDED|95.0|0.5|5.0|||ANCOVA|||||5.0|0.5|0.0179
71867144|NCT01397422|143250814|SUPERIORITY||Least Squares Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.1|5.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||5.5|1.1|0.0040
71867145|NCT01397422|143250815|SUPERIORITY||Least Squares Mean Difference|-2.2||||0.6355|TWO_SIDED|95.0|-11.2|6.9|||ANCOVA|||||6.9|-11.2|0.6355
71867146|NCT01397422|143250815|SUPERIORITY||Least Squares Mean Difference|1.7||||0.7053|TWO_SIDED|95.0|-7.2|10.6|||ANCOVA|||||10.6|-7.2|0.7053
71867147|NCT01397422|143250815|SUPERIORITY||Least Squares Mean Difference|1.2||||0.7862|TWO_SIDED|95.0|-7.7|10.1|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate||||10.1|-7.7|0.7862
71867148|NCT01397422|143250816|SUPERIORITY|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
71867149|NCT01397422|143250816|SUPERIORITY|||||||0.2158|||||||Cochran-Mantel-Haenszel|||||||0.2158
71867150|NCT01397422|143250816|SUPERIORITY|||||||0.1042|||||||Cochran-Mantel-Haenszel|Equally spaced scores||||||0.1042
71867151|NCT00513305|143250837|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED|95.0||||The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.|Chi-squared|There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced||The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.||||0.425
71867152|NCT00513305|143250838|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.829|TWO_SIDED|95.0|0.535|1.973|||Log Rank|||||1.973|0.535|0.829
71867153|NCT00513305|143250839|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|2.31||||0.527|TWO_SIDED|95.0|0.16|33.343|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||33.343|0.160|0.527
71867154|NCT00513305|143250842|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.027||||0.8289|TWO_SIDED|95.0|0.535|1.973|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.|||1.973|0.535|0.8289
71867155|NCT03798691|143250843|SUPERIORITY|||||||0.16|||||||Mann-Whitney U test|||one month after series completion of two dose series||||0.16
71867156|NCT01133418|143250915|SUPERIORITY_OR_OTHER|||||||0.36||||||a priori threshold for statistical significance was .05|General Linear Model|||||||.36
71867157|NCT01133418|143250916|SUPERIORITY_OR_OTHER|||||||0.86|||||||General Linear Model|||||||.86
71867158|NCT01133418|143250917|SUPERIORITY_OR_OTHER|||||||0.79|||||||General Linear Model|||||||.79
71867159|NCT01133418|143250918|SUPERIORITY_OR_OTHER|||||||0.77|||||||General Linear Model|||||||.77
71867160|NCT03333876|143250926|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Each group was compared to baseline.||||<.001
71867161|NCT00095498|143250931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.264|||||||van Elteren stratified rank test|||||||0.264
71867162|NCT00095498|143250931|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||van Elteren stratified rank test|||||||0.018
71867163|NCT00095498|143250932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.032|||||||van Elteren Stratified Rank Test|||||||0.032
71867164|NCT00095498|143250932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren Stratified Rank Test|||||||0.180
71867165|NCT00095498|143250933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.602|||||||van Elteren Stratified Rank Test|||||||0.602
71867166|NCT00095498|143250933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||van Elteren Stratified Rank Test|||||||0.181
71867167|NCT00095498|143250934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||van Elteren Stratified Rank Test|||||||0.012
71867168|NCT00095498|143250934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||van Elteren Stratified Rank Test|||||||0.007
71867169|NCT00095498|143250935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277|||||||van Elteren Stratified Rank Test|||||||0.277
71867170|NCT00095498|143250935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.019|||||||van Elteren Stratified Rank Test|||||||0.019
71911674|NCT00637377|143343797|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.9484||||0.076|TWO_SIDED|95.0|-4.1009|0.204||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||0.2040|-4.1009|0.076
71867171|NCT00095498|143250936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.382|||||||van Elteren Stratified Rank Test|||||||0.382
71867172|NCT00095498|143250936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.488|||||||van Elteren Stratified Rank Test|||||||0.488
71867173|NCT00095498|143250937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.236|||||||van Elteren Stratified Rank Test|||||||0.236
71867174|NCT00095498|143250937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.712|||||||van Elteren Stratified Rank Test|||||||0.712
71867175|NCT00095498|143250938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.93||||0.026||95.0|0.11|1.74|||Repeated Measures Model|||||1.74|0.11|0.026
71867176|NCT00095498|143250938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.59||||0.155||95.0|-0.23|1.41|||Repeated measures model|||||1.41|-0.23|0.155
71867177|NCT00095498|143250939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.67||||0.002||95.0|0.62|2.72|||Repeated Measures Model|||||2.72|0.62|0.002
71867178|NCT00095498|143250939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.89|||<|0.001||95.0|0.84|2.94|||Repeated Measures Model|||||2.94|0.84|<0.001
71867179|NCT00095498|143250940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|||<|0.001||95.0|1.1|3.29|||Repeated Measures Model|||||3.29|1.1|<0.001
71867180|NCT00095498|143250940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.29|||<|0.001||95.0|2.18|4.39|||Repeated Measures Model|||||4.39|2.18|<0.001
71867181|NCT00095498|143250941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01||||0.986||95.0|-1.06|1.08|||Repeated Measures Model|||||1.08|-1.06|0.986
71867182|NCT00095498|143250941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.141||95.0|-0.27|1.86|||Repeated Measures Model|||||1.86|-0.27|0.141
71867183|NCT00095498|143250942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.95||||0.073||95.0|-0.09|1.99|||Repeated Measures Model|||||1.99|-0.09|0.073
71867184|NCT00095498|143250942|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89||||0.09||95.0|-0.14|1.93|||Repeated Measures Model|||||1.93|-0.14|0.09
71867185|NCT00095498|143250943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.81||||0.007||95.0|0.51|3.12|||Repeated Measures Model|||||3.12|0.51|0.007
71867186|NCT00095498|143250943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98||||0.003||95.0|0.67|3.29|||Repeated Measures Model|||||3.29|0.67|0.003
71867187|NCT00095498|143250944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.938||95.0|-0.58|0.63|||Repeated Measures Model|||||0.63|-0.58|0.938
71867188|NCT00095498|143250944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08||||0.787||95.0|-0.53|0.69|||Repeated Measures Model|||||0.69|-0.53|0.787
71867189|NCT00095498|143250945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.004||95.0|0.33|1.67|||Repeated Measures Model|||||1.67|0.33|0.004
71867190|NCT00095498|143250945|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|||<|0.001||95.0|0.51|1.85|||Repeated Measures Model|||||1.85|0.51|<0.001
71867191|NCT00095498|143250946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.94|||<|0.001||95.0|1.02|2.85|||Repeated Measures Model|||||2.85|1.02|<0.001
71867192|NCT00095498|143250946|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.04|||<|0.001||95.0|1.13|2.96|||Repeated Measures Model|||||2.96|1.13|<0.001
71867193|NCT00095498|143250947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867194|NCT00095498|143250947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867195|NCT00095498|143250948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867196|NCT00095498|143250948|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867197|NCT00095498|143250949|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867198|NCT00095498|143250949|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867199|NCT00095498|143250950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867200|NCT00095498|143250950|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867201|NCT00095498|143250951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71911675|NCT00637377|143343797|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.062||||0.9555|TWO_SIDED|95.0|-2.2398|2.1158||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||2.1158|-2.2398|0.9555
71911676|NCT00637377|143343797|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.9014||||0.4131|TWO_SIDED|95.0|-3.0615|1.2587||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.||1.2587|-3.0615|0.4131
71911677|NCT00637377|143343798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-4.57||||0.229|TWO_SIDED|95.0|-12.02|2.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q4 group|The null hypothesis is that the two proportions are equal.||2.88|-12.02|0.229
71911678|NCT00637377|143343798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.78||||0.843|TWO_SIDED|95.0|-6.91|8.46||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 0.5mg Q4 group|The null hypothesis is that the two proportions are equal.||8.46|-6.91|0.843
71911679|NCT00637377|143343798|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.65||||0.49|TWO_SIDED|95.0|-10.18|4.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The null hypothesis is that the two proportions are equal.||4.88|-10.18|0.490
71911680|NCT00637377|143343799|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-2.7885||||0.0097|TWO_SIDED|95.0|-4.9012|-0.6757||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||-0.6757|-4.9012|0.0097
71911681|NCT00637377|143343799|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.932||||0.3917|TWO_SIDED|95.0|-3.0658|1.2019||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||1.2019|-3.0658|0.3917
71911682|NCT00637377|143343799|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.947||||0.0717|TWO_SIDED|95.0|-4.0659|0.1718||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.||0.1718|-4.0659|0.0717
71911683|NCT00637377|143343800|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-1.18||||0.0038|TWO_SIDED|95.0|-1.979|-0.382||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||-0.382|-1.979|0.0038
71911684|NCT00637377|143343800|SUPERIORITY_OR_OTHER||Differences in Least Squares means|0.17||||0.6784|TWO_SIDED|95.0|-0.632|0.972||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.972|-0.632|0.6784
71911685|NCT00637377|143343800|SUPERIORITY_OR_OTHER||Differences in Least Squares means|-0.733||||0.0727|TWO_SIDED|95.0|-1.534|0.068||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.||0.068|-1.534|0.0727
71911686|NCT01938001|143343801|SUPERIORITY||Hazard Ratio (HR)|0.46|||<|0.0001|TWO_SIDED|95.0|0.34|0.62|||Log Rank|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.62|0.34|< 0.0001
71911687|NCT01938001|143343802|SUPERIORITY|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||0.0006
71911688|NCT01938001|143343803|SUPERIORITY||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.37|0.95||||||Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||0.95|0.37|
71911689|NCT01938001|143343804|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||< 0.0001
71911690|NCT01938001|143343805|SUPERIORITY||||||=|0.001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||||= 0.0010
71867202|NCT00095498|143250951|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867203|NCT00095498|143250952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016|||||||van Elteren Stratified Rank Test|||||||0.016
71911691|NCT01938001|143343806|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0015|TWO_SIDED|95.0|0.36|0.79|||Log Rank|||||0.79|0.36|0.0015
71911692|NCT01938001|143343807|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.2993|TWO_SIDED|95.0|0.32|1.43|||Log Rank|||||1.43|0.32|0.2993
71911693|NCT01938001|143343808|SUPERIORITY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.38|0.67|||Stratified Log-Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).|Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.|||0.67|0.38|< 0.0001
71911694|NCT01938001|143343809|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.39|0.71|||Stratified Log Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).||||0.71|0.39|<0.0001
71911695|NCT02483078|143343846|SUPERIORITY|||||||0.0032|||||||Fisher Exact|The Fisher's Exact test if the count in any cell was less than 5; otherwise Chi-Square test was to be used||||||.0032
71911696|NCT02483078|143343847|SUPERIORITY|||||||0.0377|||||||Fisher Exact|||||||.0377
71911697|NCT02483078|143343848|SUPERIORITY|||||||0.1201|||||||Fisher Exact|||||||.1201
71911698|NCT02483078|143343849|SUPERIORITY|||||||0.0013|||||||ANCOVA|||||||.0013
71911699|NCT02483078|143343853|SUPERIORITY|||||||0.7123|||||||ANCOVA|||The raw and change from baseline in CD4 cell count at the end of the 1-week double blind treatment period was to be summarized by treatment group for the first week during the double-blind treatment phase. For change from baseline summaries, subjects with an undefined change from baseline, because of missing data, were to be excluded.||||.7123
71867204|NCT00095498|143250952|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867205|NCT00095498|143250953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867206|NCT00095498|143250953|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||van Elteren Stratified Rank Test|||||||<0.001
71867207|NCT00095498|143250954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|||||||van Elteren Stratified Rank Test|||||||0.673
71867208|NCT00095498|143250954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.589|||||||van Elteren Stratified Rank Test|||||||0.589
71867209|NCT00095498|143250955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||van Elteren Stratified Rank Test|||||||0.175
71867210|NCT00095498|143250955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.133|||||||van Elteren Stratified Rank Test|||||||0.133
71867211|NCT03439254|143251088|OTHER||Response ratio(Mantel-Haenszel estimate)|1.13||||0.6172|TWO_SIDED|95.0|0.71|1.79|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.79|0.71|0.6172
71867212|NCT03439254|143251088|OTHER||Response ratio(Mantel-Haenszel estimate)|1.2||||0.4184|TWO_SIDED|95.0|0.77|1.89|||Cochran-Mantel-Haenszel||Treatment / Placebo Response Ratio = Percentage of Responders in Active Treatment Arm / Percentage of Responders in Placebo, stratified by Baseline diabetes status (yes/no).|||1.89|0.77|0.4184
71867213|NCT02075476|143251102|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.048|||||||Mixed Models Analysis|||||||0.048
71911700|NCT02483078|143343855|SUPERIORITY|||||||0.0993|||||||Fisher Exact|||||||.0993
71911701|NCT04532918|143343884|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|255.3|||||TWO_SIDED|90.0|208.7|312.3|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax||312.3|208.7|
71911702|NCT04532918|143343884|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|189.5|||||TWO_SIDED|90.0|154.0|233.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax||233.1|154.0|
71911703|NCT04532918|143343885|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|238.4|||||TWO_SIDED|90.0|207.6|273.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||273.8|207.6|
71911704|NCT04532918|143343885|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|148.9|||||TWO_SIDED|90.0|129.1|171.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf||171.7|129.1|
71911705|NCT04532918|143343886|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|261.8|||||TWO_SIDED|90.0|229.8|298.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast||298.1|229.8|
71911706|NCT04532918|143343886|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|163.2|||||TWO_SIDED|90.0|142.8|186.6|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast||186.6|142.8|
71911707|NCT04532918|143343887|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|273.4|||||TWO_SIDED|90.0|227.9|328.1|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||328.1|227.9|
71867214|NCT02075476|143251103|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.001|||||||Mixed Models Analysis|||||||0.001
71867215|NCT02075476|143251104|EQUIVALENCE|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.011|||||||Mixed Models Analysis|||||||0.011
71911708|NCT04532918|143343887|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|275.9|||||TWO_SIDED|90.0|228.7|332.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||332.7|228.7|
71911709|NCT04532918|143343887|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|24.65|||||TWO_SIDED|90.0|19.15|31.72|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||31.72|19.15|
71911710|NCT04532918|143343887|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|37.82|||||TWO_SIDED|90.0|29.18|49.03|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M8||49.03|29.18|
71911711|NCT04532918|143343888|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|291.8|||||TWO_SIDED|90.0|260.6|326.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M1||326.8|260.6|
71911712|NCT04532918|143343888|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|215.8|||||TWO_SIDED|90.0|192.0|242.4|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for metabolite: M1||242.4|192.0|
71911713|NCT04532918|143343888|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|55.31|||||TWO_SIDED|90.0|47.19|64.83|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||64.83|47.19|
71911714|NCT04532918|143343888|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|68.28|||||TWO_SIDED|90.0|57.99|80.39|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for metabolite: M8||80.39|57.99|
71911715|NCT04532918|143343889|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|306.4|||||TWO_SIDED|90.0|273.3|343.6|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||343.6|273.3|
71911716|NCT04532918|143343889|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|227.4|||||TWO_SIDED|90.0|202.1|255.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M1||255.8|202.1|
71911717|NCT04532918|143343889|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|51.03|||||TWO_SIDED|90.0|43.8|59.45|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||59.45|43.80|
71867216|NCT00923260|143251118|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||t-test, 2 sided|||||||0.79
71867217|NCT00923260|143251119|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||t-test, 2 sided|||||||0.49
71867218|NCT00923260|143251120|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
71867219|NCT00923260|143251121|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||||||.86
71682794|NCT00824382|142883779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.678|STANDARD_ERROR_OF_MEAN|5.431|<|0.0001||95.0|25.987|47.369|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.369|25.987|<0.0001
71867220|NCT00923260|143251122|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||t-test, 2 sided|||||||0.60
71682795|NCT00824382|142883780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.052|STANDARD_ERROR_OF_MEAN|5.534|<|0.0001||95.0|18.159|39.946|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||39.946|18.159|<0.0001
71867221|NCT00923260|143251123|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|||||||0.76
71867222|NCT00923260|143251124|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||||||0.45
71867223|NCT00923260|143251125|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||||||0.81
71867224|NCT00923260|143251126|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
71867225|NCT00923260|143251127|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||||||0.01
71867226|NCT00923260|143251128|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|||||||0.15
71867227|NCT00923260|143251129|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||t-test, 2 sided|||||||0.20
71867228|NCT00923260|143251130|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
71867229|NCT00923260|143251131|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||t-test, 2 sided|||||||0.92
71911718|NCT04532918|143343889|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|70.45|||||TWO_SIDED|90.0|60.21|82.44|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for metabolite: M8||82.44|60.21|
71911719|NCT04532918|143343890|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|74.84|||||TWO_SIDED|90.0|59.42|94.26|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||94.26|59.42|
71682796|NCT00824382|142883780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.955|STANDARD_ERROR_OF_MEAN|5.635|<|0.0001||95.0|19.861|42.049|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||42.049|19.861|<0.0001
71682797|NCT00824382|142883780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.191|STANDARD_ERROR_OF_MEAN|5.489|<|0.0001||95.0|26.386|47.996|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||47.996|26.386|<0.0001
71682798|NCT00824382|142883781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.191|STANDARD_ERROR_OF_MEAN|0.149||0.2016||95.0|-0.485|0.103|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo|||0.103|-0.485|0.2016
71682799|NCT00824382|142883781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.454|STANDARD_ERROR_OF_MEAN|0.151||0.0029||95.0|-0.752|-0.156|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo|||-0.156|-0.752|0.0029
71682800|NCT00824382|142883781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|STANDARD_ERROR_OF_MEAN|0.148||0.0095||95.0|-0.678|-0.095|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo|||-0.095|-0.678|0.0095
71682801|NCT01362244|142883788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0|||||Fisher Exact|||Statistical data is presented for NR||||0.003
71682802|NCT01362244|142883788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.016||95.0|||||Fisher Exact|||Statistical data is presented for LOCF||||0.016
71911720|NCT04532918|143343890|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|80.99|||||TWO_SIDED|90.0|63.88|102.7|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for allopurinol||102.7|63.88|
71911721|NCT04532918|143343890|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.86|||||TWO_SIDED|90.0|92.11|101.8|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||101.8|92.11|
71911722|NCT04532918|143343890|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.07|||||TWO_SIDED|90.0|94.36|104.0|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of Cmax for oxypurinol||104.0|94.36|
71911723|NCT04532918|143343891|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.29|||||TWO_SIDED|90.0|91.26|105.9|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||105.9|91.26|
71911724|NCT04532918|143343891|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.2|||||TWO_SIDED|90.0|93.72|109.2|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for allopurinol||109.2|93.72|
71911725|NCT04532918|143343891|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|99.16|||||TWO_SIDED|90.0|95.02|103.5|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||103.5|95.02|
71911726|NCT04532918|143343891|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|96.05|||||TWO_SIDED|90.0|92.15|100.1|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUCinf for oxypurinol||100.1|92.15|
71911727|NCT04532918|143343892|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.25|||||TWO_SIDED|90.0|91.1|106.0|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||106.0|91.10|
71911728|NCT04532918|143343892|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|101.6|||||TWO_SIDED|90.0|93.99|109.8|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Statistical comparison of AUClast for allopurinol||109.8|93.99|
71911729|NCT04532918|143343892|OTHER|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects|Geometric Mean Ratio (%)|98.05|||||TWO_SIDED|90.0|94.5|101.7|||||Pairwise comparisons of Test 1/ reference (verinurad+allopurinol+cyclosporine/ verinurad+allopurinol alone)|Statistical comparison of AUClast for oxypurinol||101.7|94.50|
71911730|NCT04532918|143343892|OTHER||Geometric Mean Ratio (%)|95.98|||||TWO_SIDED|90.0|92.61|99.48|||||Pairwise comparisons of Test 2/ reference (verinurad+allopurinol+rifampicin/ verinurad+allopurinol alone)|Analysis of variance of log transformed PK parameter with treatment and participant as fixed effects||99.48|92.61|
71911731|NCT02564029|143343911|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.86|-8.60|
71682803|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74||||0.71|TWO_SIDED|95.0|0.15|3.64|||Regression, Logistic||Week 1|||3.64|0.15|0.710
71867230|NCT00923260|143251132|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71867231|NCT00923260|143251133|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
71867232|NCT00923260|143251134|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
71867233|NCT00923260|143251135|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||t-test, 2 sided|||||||0.33
71867234|NCT00923260|143251136|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||t-test, 2 sided|||||||0.39
71867235|NCT00923260|143251137|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
71682804|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.4||||0.674|TWO_SIDED|95.0|0.29|6.87|||Regression, Logistic||Week 2|||6.87|0.29|0.674
71682805|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.94||||0.942|TWO_SIDED|95.0|0.2|4.49|||Regression, Logistic||Week 5|||4.49|0.20|0.942
71682806|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.9||||0.091|TWO_SIDED|95.0|0.8|18.96|||Regression, Logistic||Week 9|||18.96|0.80|0.091
71682807|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.66||||0.004|TWO_SIDED|95.0|2.18|62.33|||Regression, Logistic||Week 13|||62.33|2.18|0.004
71867236|NCT00923260|143251138|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||t-test, 2 sided|||||||0.75
71682808|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.74||||0.224|TWO_SIDED|95.0|0.54|13.9|||Regression, Logistic||Week 17|||13.90|0.54|0.224
71682809|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.69|||Regression, Logistic||Week 21|||30.69|1.11|0.037
71682810|NCT01362244|142883789|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.22||||0.051|TWO_SIDED|95.0|0.99|27.44|||Regression, Logistic||Week 25|||27.44|0.99|0.051
71867237|NCT00923260|143251139|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||||||0.94
71867238|NCT00923260|143251140|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
71867239|NCT00923260|143251141|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
71867240|NCT00923260|143251142|SUPERIORITY_OR_OTHER|||||||0.67||95.0|||||t-test, 2 sided|||||||0.67
71867241|NCT00923260|143251143|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
71867242|NCT00923260|143251144|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||||||0.038
71867243|NCT00923260|143251145|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||t-test, 2 sided|||||||0.14
71867244|NCT00923260|143251146|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||||||0.21
71867245|NCT00923260|143251147|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
71867246|NCT00923260|143251148|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
71867247|NCT00923260|143251149|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||t-test, 2 sided|||||||0.10
71867248|NCT00923260|143251150|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||||||0.16
71867249|NCT00923260|143251151|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||t-test, 2 sided|||||||0.18
71867250|NCT00923260|143251152|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|||||||0.40
71867251|NCT00923260|143251153|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
71867252|NCT00923260|143251154|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|||||||0.035
71867253|NCT00923260|143251155|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||t-test, 2 sided|||||||0.07
71867254|NCT00923260|143251156|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||t-test, 2 sided|||||||0.99
71867255|NCT00923260|143251157|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||t-test, 2 sided|||||||0.96
71867256|NCT00923260|143251158|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||||||0.44
71867257|NCT00923260|143251159|SUPERIORITY_OR_OTHER|||||||0.97||95.0|||||t-test, 2 sided|||||||0.97
71867258|NCT00923260|143251160|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||||||0.85
71867259|NCT00923260|143251161|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||||||0.61
71867260|NCT00923260|143251162|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||t-test, 2 sided|||||||0.55
71867261|NCT00923260|143251163|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||t-test, 2 sided|||||||0.65
71867262|NCT00923260|143251164|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||||||0.74
71867263|NCT00923260|143251165|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
71867264|NCT00923260|143251166|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||t-test, 2 sided|||||||0.87
71867265|NCT00923260|143251167|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||||||0.28
71682811|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.567|TWO_SIDED|95.0|-0.1|0.19|||repeated measures model||Week 2|||0.19|-0.10|0.567
71867266|NCT00923260|143251168|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
71867267|NCT00923260|143251169|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||t-test, 2 sided|||||||0.42
71911732|NCT02564029|143343911|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-3.06|-7.78|
71911733|NCT02564029|143343911|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||-2.84|-7.60|
71911734|NCT02564029|143343911|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||3.20|-1.58|
71911735|NCT02564029|143343911|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repreated Measure Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||1.41|-3.43|
71911736|NCT02564029|143343911|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.||2.16|-2.56|
71911737|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-6.23|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-8.6|-3.86|||Mixed Model Repeated Measure Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.86|-8.60|
71911738|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-7.78|-3.06|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.06|-7.78|
71911739|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-5.22|STANDARD_ERROR_OF_MEAN|1.37|||TWO_SIDED|90.0|-7.6|-2.84|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-2.84|-7.60|
71911740|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-1.58|3.2|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||3.20|-1.58|
71682812|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05||||0.495|TWO_SIDED|95.0|-0.1|0.21|||repeated measures model||Week 5|||0.21|-0.10|0.495
71682813|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.365|TWO_SIDED|95.0|-0.1|0.28|||repeated measures model||Week 9|||0.28|-0.10|0.365
71682814|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17||||0.058|TWO_SIDED|95.0|-0.01|0.34|||repeated measures model||Week 13|||0.34|-0.01|0.058
71682815|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21||||0.056|TWO_SIDED|95.0|-0.01|0.43|||repeated measures model||Week 17|||0.43|-0.01|0.056
71682816|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23||||0.028|TWO_SIDED|95.0|0.03|0.42|||repeated measures model||Week 21|||0.42|0.03|0.028
71867268|NCT00923260|143251170|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
71682817|NCT01362244|142883806|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16||||0.077|TWO_SIDED|95.0|-0.02|0.34|||repeated measures model||Week 25|||0.34|-0.02|0.077
71867269|NCT00923260|143251171|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||||||0.68
71867270|NCT00923260|143251172|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
71867271|NCT00923260|143251173|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||t-test, 2 sided|||||||0.71
71867272|NCT00923260|143251174|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||t-test, 2 sided|||||||0.32
71867273|NCT00923260|143251175|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||t-test, 2 sided|||||||0.64
71867274|NCT00923260|143251176|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||t-test, 2 sided|||||||0.52
71867275|NCT00923260|143251177|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||t-test, 2 sided|||||||0.59
71867276|NCT00923260|143251178|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||t-test, 2 sided|||||||0.57
71867277|NCT00923260|143251179|SUPERIORITY_OR_OTHER|||||||0.43||95.0|||||t-test, 2 sided|||||||0.43
71867278|NCT00923260|143251180|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||t-test, 2 sided|||||||0.72
71867279|NCT00923260|143251181|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||t-test, 2 sided|||||||0.56
71867280|NCT00660543|143251182|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.003
71867281|NCT00660543|143251182|SUPERIORITY_OR_OTHER|||||||0.008|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.||||||.008
71867282|NCT03829475|143251184|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71867283|NCT00943852|143251233|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
71867284|NCT00943852|143251234|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period||||||<0.001
71867285|NCT01247285|143251252|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.81|||||TWO_SIDED|90.0|97.37|119.38|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||119.38|97.37|
71911741|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-1.01|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|-3.43|1.41|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.41|-3.43|
71911742|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|1.36|||TWO_SIDED|90.0|-2.56|2.16|||Mixed Model Repeated Measures Analysis|||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||2.16|-2.56|
71911743|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-6.51|STANDARD_ERROR_OF_MEAN|0.79|||TWO_SIDED|90.0|-8.01|-5.01|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-5.01|-8.01|
71911744|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-6.44|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|90.0|-7.93|-4.95|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.95|-7.93|
71911745|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-5.74|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-7.2|-4.28|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-4.28|-7.20|
71911746|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-1.31|1.46|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.46|-1.31|
71911747|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-2.19|0.65|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.65|-2.19|
71911748|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|90.0|-2.09|0.7|||Mixed Model Repeated Measures Analysis|||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||0.70|-2.09|
71911749|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-4.42|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|90.0|-5.6|-3.25|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.25|-5.60|
71911750|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.17|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.17|-5.57|
71911751|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-4.38|STANDARD_ERROR_OF_MEAN|0.69|||TWO_SIDED|90.0|-5.57|-3.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||-3.19|-5.57|
71911752|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.08|1.19|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.19|-1.08|
71911753|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|90.0|-1.18|1.1|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.10|-1.18|
71911754|NCT02564029|143343912|OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.65|||TWO_SIDED|90.0|-1.11|1.13|||Mixed Model Repeated Measures Analysis|||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.||1.13|-1.11|
71911755|NCT00617656|143343957|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.56|TWO_SIDED|95.0|0.76|1.67|||Log Rank|||This is a futility analysis. The initial hypothesis of the clinical trial was that the experimental group as a whole was superior to the control group.||1.67|0.76|0.56
71911756|NCT00617656|143343957|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.79|TWO_SIDED|95.0|0.73|1.51|||Log Rank|||||1.51|0.73|0.79
71911757|NCT00617656|143343957|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.0001|TWO_SIDED|95.0|1.38|2.95|||Log Rank|||||2.95|1.38|0.0001
71911758|NCT00617656|143343958|SUPERIORITY||Hazard Ratio (HR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.12|||Log Rank|||||2.12|1.13|0.006
71911759|NCT03366844|143343959|OTHER||Proportion|0.6|||||TWO_SIDED|95.0|0.465|0.724|||||95% confidence interval for one proportion were estimated using the Exact (Clopper-Pearson) method.|||0.724|0.465|
71911760|NCT00789724|143343965|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANOVA|||||||0.033
71911761|NCT02688153|143343974|SUPERIORITY||Median Difference (Final Values)|-4.5||||0.366|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.3660
71911762|NCT02688153|143343975|SUPERIORITY||Median Difference (Final Values)|2.0||||0.8377|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.8377
71911763|NCT01135394|143344003|OTHER|The genes with p-values below 10\^-6 were identified|Pearson correlation p-value|0.0000001|||<|1e-07|TWO_SIDED|||||The genes with p-values below 10\^-6 were identified|Genes with p-values below 10^-6|||After the change (end-of-treatment minus baseline) in HOMA-IR index had been calculated for each subject, the change (end-of-treatment minus baseline) in expression of each of approximately 45,000 transcripts contained in a human gene array was calculated. A Pearson correlation p-value was calculated for the correlation between change in gene expression and change in HOMA-IR index, with the purpose of identifying the genes whose expression changed in concert with changes in HOMA-IR index.|The genes with P-values below 10\^-6 were identified|||<0.0000001
71911764|NCT00191386|143344006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 6 Months|Paired t-test|||||||<0.001
71911765|NCT00191386|143344006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 12 Months|Paired t-test|||||||<0.001
71911766|NCT00191386|143344006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 2 Years.|Paired t-test|||||||<0.001
71911767|NCT00191386|143344006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 3 Years.|Paired t-test|||||||<0.001
71911768|NCT00191386|143344006|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for Total Score 4 Years.|Paired t-test|||||||<0.001
71911769|NCT00191386|143344007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 6 Months.|Paired t-test|||||||<0.001
71911770|NCT00191386|143344007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 12 Months.|Paired t-test|||||||<0.001
71911771|NCT00191386|143344007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 2 Years.|Paired t-test|||||||<0.001
71911772|NCT00191386|143344007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 3 Years.|Paired t-test|||||||<0.001
71911773|NCT00191386|143344007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-Value for 4 Years.|Paired t-test|||||||<0.001
71911774|NCT00439725|143344015|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.185|STANDARD_ERROR_OF_MEAN|0.3858|<|0.0001||95.0|0.087|0.393||1st test in a hierarchy, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing).||0.393|0.087|< 0.0001
71911775|NCT00439725|143344016|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|STANDARD_ERROR_OF_MEAN|0.385|<|0.0001||95.0|0.085|0.383||2nd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the 1st test in hierarchy was significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.383|0.085|< 0.0001
71911776|NCT00439725|143344017|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.198|STANDARD_ERROR_OF_MEAN|0.3659|<|0.0001||95.0|0.096|0.405||3rd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.405|0.096|< 0.0001
71911777|NCT00439725|143344018|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.278|STANDARD_ERROR_OF_MEAN|0.3274|<|0.0001||95.0|0.146|0.528||4th test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).||0.528|0.146|< 0.0001
71911778|NCT00439725|143344021|SUPERIORITY_OR_OTHER|||||||0.1121||||||No adjustment for multiple comparison.|Log Rank|||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||||0.1121
71911779|NCT00439725|143344022|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.185|STANDARD_ERROR_OF_MEAN|0.4131|<|0.0001||95.0|2.307|11.652||No adjustment for multiple comparison, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment done for treatment-emergent (time window: 2 days)||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.||11.652|2.307|< 0.0001
71911780|NCT01673490|143344048|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71911781|NCT01673490|143344049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 3|t-test, 2 sided|||||||<0.001
71911782|NCT01673490|143344049|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||for Month 6|t-test, 2 sided|||||||<0.001
71911783|NCT00379236|143344051|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANCOVA|Screening pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.008
71911784|NCT00379236|143344052|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is purely nominal|ANCOVA|||||||0.001
71911785|NCT00379236|143344053|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Chi-squared|||||||0.202
71911786|NCT00379236|143344054|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||Chi-squared|||||||0.047
71911787|NCT00379236|143344055|SUPERIORITY_OR_OTHER|||||||0.618||95.0|||||Chi-squared|||||||0.618
71911788|NCT00379236|143344056|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Chi-squared|||||||0.028
71911789|NCT00379236|143344057|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|Baseline pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.||||||0.002
71911790|NCT00379236|143344068|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
71867286|NCT01247285|143251253|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.69|||||TWO_SIDED|90.0|92.9|109.14|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.14|92.90|
71682818|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.486|TWO_SIDED|95.0|-0.1|0.22|||repeated measures model||Week 2|||0.22|-0.10|0.486
71867287|NCT01247285|143251254|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.77|||||TWO_SIDED|90.0|93.53|108.56|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||108.56|93.53|
71682819|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07||||0.384|TWO_SIDED|95.0|-0.08|0.22|||repeated measures model||Week 5|||0.22|-0.08|0.384
71867288|NCT01247285|143251255|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.88|||||TWO_SIDED|90.0|98.53|111.64|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.64|98.53|
71867289|NCT01247285|143251256|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.64|||||TWO_SIDED|90.0|99.97|111.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||111.56|99.97|
71867290|NCT01247285|143251257|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.05|||||TWO_SIDED|90.0|94.76|107.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.|||107.77|94.76|
71867291|NCT01416389|143251258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.344|||||||t-test, 1 sided|||This measure is compared between two treatment arms using a one-sided t-test. This measure followed a normal distribution.||||0.344
71867292|NCT01416389|143251259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.608|||||||Chi-squared|||||||0.608
71867293|NCT01416389|143251261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.365|||||||Chi-squared|||||||0.365
71867294|NCT00858364|143251284|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.83|1.01|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.01|0.83|
71867295|NCT00858364|143251284|NON_INFERIORITY|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.83|1.0|||||A hazard ratio \< 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.00|0.83|
71867296|NCT00858364|143251284|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.07|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin)||||||0.070
71867297|NCT00858364|143251284|SUPERIORITY|||||||0.047|||||||Log Rank|Unstratified log rank test||||||0.047
71867298|NCT00858364|143251284|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.84|1.02||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.02|0.84|
71867299|NCT00858364|143251285|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.||1.04|0.87|
71867300|NCT00858364|143251285|NON_INFERIORITY|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.87|1.04|||||A hazard ratio \< 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.||1.04|0.87|
71867301|NCT00858364|143251285|SUPERIORITY|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.31|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||||||0.31
71867302|NCT00858364|143251285|SUPERIORITY|||||||0.27|||||||Log Rank|Unstratified log rank test||||||0.27
71867303|NCT00858364|143251285|OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.05||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).||1.05|0.88|
71682820|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06||||0.546|TWO_SIDED|95.0|-0.14|0.26|||repeated measures model||Week 9|||0.26|-0.14|0.546
71867304|NCT00858364|143251286|SUPERIORITY|If non-inferiority was declared for OS and PFS, superiority would be declared for the transfusion endpoint if the p-value from a two-sided test of significance using the Cochran-Mantel-Haenszel method was less than 0.05 in favor of the darbepoetin alfa group.|Odds Ratio (OR)|0.704|||<|0.001|TWO_SIDED|95.0|0.573|0.864|||Cochran-Mantel-Haenszel||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).||0.864|0.573|< 0.001
71867305|NCT00858364|143251286|OTHER||Odds Ratio (OR)|0.705|||<|0.001|TWO_SIDED|95.0|0.574|0.866|||Regression, Logistic||An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).||0.866|0.574|< 0.001
71682821|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.05|TWO_SIDED|95.0|0.0|0.39|||repeated measures model||Week 13|||0.39|0.00|0.050
71682822|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22||||0.061|TWO_SIDED|95.0|-0.01|0.45|||repeated measures model||Week 17|||0.45|-0.01|0.061
71682823|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.016|TWO_SIDED|95.0|0.05|0.51|||repeated measures model||Week 21|||0.51|0.05|0.016
71867306|NCT00858364|143251288|OTHER||Odds Ratio (OR)|1.173||||0.076|TWO_SIDED|95.0|0.983|1.401|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||1.401|0.983|0.076
71867307|NCT00858364|143251288|OTHER||Odds Ratio (OR)|1.173||||0.078|TWO_SIDED|95.0|0.982|1.401|||Cochran-Mantel-Haenszel|Unstratified analysis||||1.401|0.982|0.078
71867308|NCT00858364|143251290|OTHER||Odds Ratio (OR)|0.741||||0.003|TWO_SIDED|95.0|0.61|0.901|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio \< 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|||0.901|0.610|0.003
71867309|NCT00858364|143251290|OTHER||Odds Ratio (OR)|0.758||||0.003|TWO_SIDED|95.0|0.63|0.913|||Cochran-Mantel-Haenszel|Unstratified analysis||||0.913|0.630|0.003
71867310|NCT02186600|143251382|OTHER|Hierarchical linear modeling for intent-to-treat analysis to analyze time X group interactions, adjusted for baseline total body lean mass and height.||||||0.7|||||||hierarchical linear modeling|controlled for total lean mass and height||||||0.7
71867311|NCT02186600|143251383|OTHER|hierarchical linear modeling||||||0.01|||||||hierarchical linear modeling|||||||0.01
71867312|NCT02186600|143251384|OTHER|Hierarchical linear modeling|||||<|0.007|||||||hierarchical linear modeling|||||||<0.007
71867313|NCT03026075|143251385|SUPERIORITY||||||<|0.01|||||||McNemar|||"The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)"||||<0.01
71911791|NCT02940860|143344073|NON_INFERIORITY|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.08|||||TWO_SIDED|95.0|-0.06|0.23|||||The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."||0.23|-0.06|
71911792|NCT02940860|143344074|OTHER||95% two-sided CI (iron isomaltoside)|0.3|||||TWO_SIDED|95.0|0.06|0.86||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."||0.86|0.06|
71911793|NCT02940860|143344074|OTHER||Risk Difference (RD)|0.29|||||TWO_SIDED|95.0|-0.19|0.77||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.77|-0.19|
71911794|NCT02940860|143344074|NON_INFERIORITY|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.||0.48|-0.57|
71867314|NCT01468181|143251388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.77|||<|0.001|TWO_SIDED|95.0|-1.87|-1.67|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 26 Weeks||-1.67|-1.87|<0.001
71867315|NCT01468181|143251388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|||<|0.001|TWO_SIDED|95.0|-1.75|-1.55|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 52 Weeks||-1.55|-1.75|<0.001
71867316|NCT01468181|143251390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-43.9|||<|0.001|TWO_SIDED|95.0|-47.8|-40.0|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 26 Weeks||-40.0|-47.8|<0.001
71867317|NCT01468181|143251390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.4|-38.7|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 52 Weeks||-38.7|-46.4|<0.001
71867318|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.42|||<|0.001|TWO_SIDED|95.0|-46.55|-38.29|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 26 Weeks||-38.29|-46.55|<0.001
71682824|NCT01362244|142883807|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18||||0.094|TWO_SIDED|95.0|-0.03|0.4|||repeated measures model||Week 25|||0.40|-0.03|0.094
71867319|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.6|||<|0.001|TWO_SIDED|95.0|-46.44|-38.76|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 52 Weeks||-38.76|-46.44|<0.001
71867320|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-68.48|||<|0.001|TWO_SIDED|95.0|-74.18|-62.79|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 26 Weeks||-62.79|-74.18|<0.001
71867321|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.08|||<|0.001|TWO_SIDED|95.0|-72.12|-60.04|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 52 Weeks||-60.04|-72.12|<0.001
71911795|NCT02940860|143344075|SUPERIORITY|||||||0.0248|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher's exact test.||||0.0248
71911796|NCT02940860|143344076|SUPERIORITY|||||||0.0185|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.||||0.0185
71911797|NCT02940860|143344078|SUPERIORITY||Odds Ratio (OR)|1.37||||0.0478|TWO_SIDED|95.0|1.0|1.87|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥1 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.87|1.00|0.0478
71911798|NCT02940860|143344078|SUPERIORITY||Odds Ratio (OR)|1.81|||<|0.0001|TWO_SIDED|95.0|1.39|2.36|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥1 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||2.36|1.39|<0.0001
71911799|NCT02940860|143344078|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0048|TWO_SIDED|95.0|1.11|1.79|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥1 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.79|1.11|0.0048
71911800|NCT02940860|143344078|SUPERIORITY||Odds Ratio (OR)|1.01||||0.944|TWO_SIDED|95.0|0.8|1.27|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥1 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."||1.27|0.80|0.9440
71911801|NCT02940860|143344079|SUPERIORITY|||||||0.0174|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.||||0.0174
71911802|NCT02940860|143344080|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5074|TWO_SIDED|95.0|0.83|1.45|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of \>12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.||1.45|0.83|0.5074
71911803|NCT02940860|143344081|SUPERIORITY||Odds Ratio (OR)|1.24||||0.1035|TWO_SIDED|95.0|0.96|1.6|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."||1.60|0.96|0.1035
71911804|NCT02940860|143344082|SUPERIORITY||Odds Ratio (OR)|1.82|||<|0.0001|TWO_SIDED|95.0|1.38|2.4|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."||2.40|1.38|<0.0001
71911805|NCT02940860|143344083|SUPERIORITY||Mean Difference (Final Values)|0.22|||<|0.0001|TWO_SIDED|95.0|0.12|0.31|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.31|0.12|<0.0001
71911806|NCT02940860|143344083|SUPERIORITY||Mean Difference (Final Values)|0.25|||<|0.0001|TWO_SIDED|95.0|0.14|0.36|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.36|0.14|<0.0001
71911807|NCT02940860|143344083|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0208|TWO_SIDED|95.0|0.02|0.28|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."||0.28|0.02|0.0208
71911808|NCT02940860|143344084|SUPERIORITY||Mean Difference (Final Values)|309.2|||<|0.0001|TWO_SIDED|95.0|280.7|337.8|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||337.8|280.7|<0.0001
71911809|NCT02940860|143344084|SUPERIORITY||Mean Difference (Final Values)|95.8|||<|0.0001|TWO_SIDED|95.0|67.9|123.7|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||123.7|67.9|<0.0001
71911810|NCT02940860|143344084|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.7834|TWO_SIDED|95.0|-21.2|28.1|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||28.1|-21.2|0.7834
71911811|NCT02940860|143344084|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.7621|TWO_SIDED|95.0|-18.1|24.7|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||24.7|-18.1|0.7621
71682825|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.11||||0.686|TWO_SIDED|95.0|-19.91|30.12|||repeated measures model||Week 2|||30.12|-19.91|0.686
71867322|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.21|||<|0.001|TWO_SIDED|95.0|-53.32|-43.09|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 26 Weeks||-43.09|-53.32|<0.001
71867323|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-47.51|||<|0.001|TWO_SIDED|95.0|-52.77|-42.24|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 52 Weeks||-42.24|-52.77|<0.001
71867324|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-67.06|||<|0.001|TWO_SIDED|95.0|-73.02|-61.11|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 26 Weeks||-61.11|-73.02|<0.001
71867325|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-63.17|||<|0.001|TWO_SIDED|95.0|-69.16|-57.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 52 Weeks||-57.18|-69.16|<0.001
71867326|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.0|||<|0.001|TWO_SIDED|95.0|-49.67|-38.34|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 26 Weeks||-38.34|-49.67|<0.001
71867327|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.88|||<|0.001|TWO_SIDED|95.0|-49.55|-38.21|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 52 Weeks||-38.21|-49.55|<0.001
71867328|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-62.91|||<|0.001|TWO_SIDED|95.0|-69.32|-56.5|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 26 Weeks||-56.50|-69.32|<0.001
71867329|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.84|||<|0.001|TWO_SIDED|95.0|-66.95|-54.74|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 52 Weeks||-54.74|-66.95|<0.001
71867330|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.15|||<|0.001|TWO_SIDED|95.0|-66.93|-55.37|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 26 Weeks||-55.37|-66.93|<0.001
71867331|NCT01468181|143251391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.16|||<|0.001|TWO_SIDED|95.0|-66.07|-54.25|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 52 Weeks||-54.25|-66.07|<0.001
71867332|NCT01468181|143251392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|||<|0.277|TWO_SIDED|95.0|-0.4|0.12|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 26 Weeks||0.12|-0.40|<0.277
71867333|NCT01468181|143251392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.382|TWO_SIDED|95.0|-0.42|0.16|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 52 Weeks||0.16|-0.42|0.382
71867334|NCT01468181|143251393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.59|||<|0.001|TWO_SIDED|95.0|26.0|31.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 26 Weeks||31.18|26.00|<0.001
71867335|NCT01468181|143251393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.57|||<|0.001|TWO_SIDED|95.0|24.73|30.41|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 52 Weeks||30.41|24.73|<0.001
71867336|NCT01468181|143251393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.57||||0.194|TWO_SIDED|95.0|-6.46|1.32|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 26 Weeks||1.32|-6.46|0.194
71867337|NCT01468181|143251393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.4|TWO_SIDED|65.0|-5.68|2.27|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 52 Weeks||2.27|-5.68|0.400
71867338|NCT00611975|143251520|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.8
71867339|NCT00611975|143251520|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.4
71867340|NCT00611975|143251521|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||Asex questionnaires were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for ASEX scores were re-assigned to phase based on time to onset of next menstrual period. Follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-2 days before NMP).||||>0.6
71867341|NCT00611975|143251521|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.6|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on ASEX scores||||>0.6
71867342|NCT00611975|143251522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||<.01
71867343|NCT00611975|143251522|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.01|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<0.01
71867344|NCT00611975|143251523|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.4|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.4
71867345|NCT00611975|143251523|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
71867346|NCT00611975|143251524|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.7
71867347|NCT00611975|143251524|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
71867348|NCT00611975|143251525|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
71867349|NCT00611975|143251525|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||<.0001
71682826|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.55||||0.321|TWO_SIDED|95.0|-14.4|43.5|||repeated measures model||Week 5|||43.50|-14.40|0.321
71867350|NCT00611975|143251526|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.9
71867351|NCT00611975|143251526|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.9|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.9
71867352|NCT00611975|143251527|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.1|||||||Mixed Models Analysis|||Blood draws were scheduled for early follicular, ovulatory and luteal phases. Menstrual phase for blood samples were re-assigned to phase based on time to onset of next menstrual period. Early follicular(35-21 days before next menstrual period (NMP)), Ovulatory (16-12 before NMP) luteal (11-3 days before NMP).||||>0.1
71867353|NCT00611975|143251527|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.7|||||||Mixed Models Analysis|||This secondary analysis examined main effect of menstrual cycle phase on hormone levels||||>0.7
71867354|NCT00359216|143251531|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9219||95.0|||||ANCOVA|||The p-value is obtained by F-test in ANCOVA to assess the treatment group difference in changes from baseline, adjusted for baseline.||||0.9219
71867355|NCT04075994|143251585|SUPERIORITY|||||||0.22||||||A priori threshold for statistical significance p\<0.05.|t-test, 2 sided|||Proportion of days covered assessed as a continuous measure (range 0-1) at 12 months between study arms adjusted for trial stratification factors (type of anticoagulant treatment). We determined that a sample size of 120 in the intervention group and 120 in the control group enables us to detect a minimum difference in PDC as small as 12.6% with 90% power. Power calculations assume use of 2-sided tests with 0.05 significance level.||||0.22
71867356|NCT01141647|143251591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.56|||||TWO_SIDED|90.0|1.8|7.07||||||||7.07|1.80|
71867357|NCT01941719|143251605|EQUIVALENCE|This trial aims to show the enhanced education is no better and no worse than the standard education|Mean Difference (Final Values)|-0.1212||||0.077|TWO_SIDED|||||significance level set at 0.05|ANCOVA|At each follow-up point, multivariate ANCOVA models were used to test for significant changes from the baseline||A mixed-effect model with repeated measures is used to compare the difference of group over time.||||0.0770
71867358|NCT01941719|143251606|EQUIVALENCE|This trial aims to show the new treatment is no better and no worse||||||0.6638||||||The threshold of significance level set at 0.05|Mixed Models Analysis|||||||0.6638
71867359|NCT01941719|143251607|EQUIVALENCE|The test will compare the number of complications between the two groups|||||<|0.05|||||||ANOVA|||||||< 0.05
71867360|NCT01480219|143251608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.74||||0.042|TWO_SIDED|95.0|1.02|2.96|||Regression, Cox|||Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.||2.96|1.02|0.042
71867361|NCT01480219|143251608|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.453|TWO_SIDED|95.0|0.71|2.14|||Regression, Cox|||HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.||2.14|0.71|0.453
71867362|NCT01744392|143251610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.2||||0.73|TWO_SIDED||||||t-test, 2 sided|||Difference between percentages. Increases in value indicate improvement in adherence.||||.73
71867363|NCT03980808|143251623|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.33|STANDARD_ERROR_OF_MEAN|0.56||0.95|TWO_SIDED||||||ANOVA|Total degrees of freedom (dof) = 17, with between groups dof = 1 and within groups dof = 16.||Composite scores were calculated for the knowledge based tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.95
71867364|NCT03980808|143251624|EQUIVALENCE|A priori significance levels were set to 0.05. As this was a pilot study on a demonstration intervention, power analysis were not performed.|Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.5376||0.093|TWO_SIDED||||||ANOVA|||Composite scores were calculated for the behavioral self-report tests tests. Differences in the pre and post test composite scores were compared using ANOVA. We tested the null hypothesis that score changes in the intervention group and control group were the same.||||0.093
71867365|NCT01655693|143251625|SUPERIORITY||Hazard Ratio (HR)|1.0|||>|0.991|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Initial 24 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||>0.991
71867366|NCT01655693|143251625|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.796|TWO_SIDED|95.0||||Treatment comparison of DT pooled with BCS used non-stratified Log-rank test at significance level p=0.05.|Log Rank|Log rank test is used after checking the proportional hazards (PH) assumption is valid. The Wilcoxon test is used when the PH assumption fails.|The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) corresponding to 95% confidence interval (CI) and type II error rate as 15%.|Follow-up 45 month assessment: the primary aim was to demonstrate the superiority of DT pooled (20 mg/m2 and 30 mg/m2) compared to BSC treatment and not individual DT groups per protocol. OS was estimated using the Kaplan-Meier method. The comparison of treatment groups (pooled DT groups versus BSC group) was performed using a non-stratified log-rank test as the primary analysis. The Cox model and Wilcoxon test was used for sensitivity analysis.||||0.796
71867367|NCT01655693|143251626|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7|TWO_SIDED|95.0||||Treatment comparison with BCS using non-stratified Log-rank test at significance level p=0.05.|Log Rank||Hazard ratio for treatment variable was determined by Cox model. The hazard ratio was controlled for the overall type I error rate at 5% (2-sided) and type II error rate as 15%.|PFS was estimated using Kaplan-Meier methods and plotted as curves by treatment group. For comparison between treatment groups (pooled DT 20 mg/m2 and 30 mg/m2 versus BSC) used Log-rank test as primary analysis. Hazard ratio, mean, and mean PFS rate were given with corresponding 95% CI.||||0.7
71682827|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.91||||0.622|TWO_SIDED|95.0|-26.79|44.6|||repeated measures model||Week 9|||44.60|-26.79|0.622
71682828|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|23.24||||0.178|TWO_SIDED|95.0|-10.75|57.22|||repeated measures model||Week 13|||57.22|-10.75|0.178
71682829|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.16||||0.052|TWO_SIDED|95.0|-0.33|76.66|||repeated measures model||Week 17|||76.66|-0.33|0.052
71867368|NCT01655693|143251627|SUPERIORITY|||||||1||||||Treatment comparison with BCS using Fisher's exact test at significance level p=0.05.|Fisher Exact|||The comparisons between groups (pooled DT 20 mg/m2 and 30mg/m2 versus BSC) used Fisher's exact test.||||1.0
71867369|NCT02285153|143251678|SUPERIORITY||Cox Proportional Hazard|0.434|STANDARD_ERROR_OF_MEAN|1.225||0.57|TWO_SIDED|95.0|0.039|4.792||Due to the low number of participants, the results of the statistical tests must be interpreted with caution!|Chi-squared|||||4.792|0.039|0.57
71867370|NCT02285153|143251679|SUPERIORITY|||||||0.057|||||||Chi-squared|||||||0.057
71867371|NCT02285153|143251680|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71867372|NCT02285153|143251681|SUPERIORITY|||||||0.467|||||||Chi-squared|||||||0.467
71867373|NCT01472549|143251705|SUPERIORITY||Risk Ratio (RR)|0.55||||0.02|TWO_SIDED|95.0|0.34|0.9|||Chi-squared|||||0.90|0.34|0.02
71867374|NCT01472549|143251706|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||||||0.24
71867375|NCT01472549|143251707|SUPERIORITY||Risk Ratio (RR)|0.76||||0.37|TWO_SIDED|95.0|0.43|1.37|||Chi-squared|||||1.37|0.43|0.37
71867376|NCT01472549|143251708|SUPERIORITY||Risk Ratio (RR)|0.73||||0.49|TWO_SIDED|95.0|0.3|1.8|||Chi-squared|||||1.80|0.30|0.49
71867377|NCT01472549|143251709|SUPERIORITY|||||||0.08|||||||Fisher Exact|||||||0.08
71867378|NCT01472549|143251710|SUPERIORITY||Risk Ratio (RR)|2.02||||0.56|TWO_SIDED|95.0|0.18|22.11|||Fisher Exact|||||22.11|0.18|0.56
71867379|NCT01489891|143251713|NON_INFERIORITY_OR_EQUIVALENCE|Beta 0.1; Alpha 0.05|Median Difference (Final Values)|30.6|STANDARD_DEVIATION|42.1|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.05
71867380|NCT03001076|143251722|SUPERIORITY||Difference in LS mean|-28.45|STANDARD_ERROR_OF_MEAN|3.022|<|0.001|TWO_SIDED|95.0|-34.376|-22.531|||ANCOVA|||||-22.531|-34.376|<0.001
71867381|NCT03001076|143251723|SUPERIORITY||Difference in LS mean|-23.56|STANDARD_ERROR_OF_MEAN|2.777|<|0.001|TWO_SIDED|95.0|-29.005|-18.121|||ANCOVA|||||-18.121|-29.005|<0.001
71867382|NCT03001076|143251724|SUPERIORITY||Difference in LS mean|-17.99|STANDARD_ERROR_OF_MEAN|2.018|<|0.001|TWO_SIDED|95.0|-21.94|-14.03|||ANCOVA|||||-14.030|-21.940|<0.001
71867383|NCT03001076|143251725|SUPERIORITY||Difference in LS mean|-19.32|STANDARD_ERROR_OF_MEAN|2.341|<|0.001|TWO_SIDED|95.0|-23.908|-14.732|||ANCOVA|||||-14.732|-23.908|<0.001
71867384|NCT03001076|143251726|SUPERIORITY||Location shift|-31.045|||<|0.001|TWO_SIDED|95.0|-44.761|-17.401|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.|||-17.401|-44.761|<0.001
71867385|NCT03001076|143251727|SUPERIORITY||Difference in LS mean|-4.53|STANDARD_ERROR_OF_MEAN|5.24|=|0.388|TWO_SIDED|95.0|-14.877|5.812|||ANCOVA|||||5.812|-14.877|=0.388
71867386|NCT03001076|143251728|SUPERIORITY||Difference in LS mean|-5.89|STANDARD_ERROR_OF_MEAN|1.845|=|0.002|TWO_SIDED|95.0|-9.528|-2.25|||ANCOVA|||||-2.250|-9.528|=0.002
71867387|NCT03001076|143251730|SUPERIORITY||Difference in LS mean|-31.09|STANDARD_ERROR_OF_MEAN|2.238|<|0.001|TWO_SIDED|95.0|-35.498|-26.682|||ANCOVA|||Change from Baseline to Week 4||-26.682|-35.498|<0.001
71867388|NCT03001076|143251730|SUPERIORITY||Difference in LS mean|-29.12|STANDARD_ERROR_OF_MEAN|2.513|<|0.001|TWO_SIDED|95.0|-34.074|-24.168|||ANCOVA|||Change from Baseline to Week 8||-24.168|-34.074|<0.001
71867389|NCT03001076|143251731|SUPERIORITY||Difference in LS mean|-25.26|STANDARD_ERROR_OF_MEAN|2.004|<|0.001|TWO_SIDED|95.0|-29.204|-21.308|||ANCOVA|||Change from Baseline to Week 4||-21.308|-29.204|<0.001
71867390|NCT03001076|143251731|SUPERIORITY||Difference in LS mean|-23.75|STANDARD_ERROR_OF_MEAN|2.268|<|0.001|TWO_SIDED|95.0|-28.219|-19.276|||ANCOVA|||Change from Baseline to Week 8||-19.276|-28.219|<0.001
71867391|NCT03001076|143251732|SUPERIORITY||Difference in LS mean|-20.41|STANDARD_ERROR_OF_MEAN|1.513|<|0.001|TWO_SIDED|95.0|-23.39|-17.43|||ANCOVA|||Change from Baseline to Week 4||-17.430|-23.390|<0.001
71867392|NCT03001076|143251732|SUPERIORITY||Difference in LS mean|-18.46|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-21.71|-15.206|||ANCOVA|||Change from Baseline to Week 8||-15.206|-21.710|<0.001
71867393|NCT03001076|143251733|SUPERIORITY||Difference in LS mean|-0.8|STANDARD_ERROR_OF_MEAN|4.99|=|0.873|TWO_SIDED|95.0|-10.663|9.059|||ANCOVA|||Change from Baseline to Week 4||9.059|-10.663|=0.873
71867394|NCT03001076|143251733|SUPERIORITY||Difference in LS mean|-0.08|STANDARD_ERROR_OF_MEAN|5.131|=|0.988|TWO_SIDED|95.0|-10.215|10.055|||ANCOVA|||Change from Baseline to Week 8||10.055|-10.215|=0.988
71867395|NCT03001076|143251734|SUPERIORITY||Difference in LS mean|-8.59|STANDARD_ERROR_OF_MEAN|1.619|<|0.001|TWO_SIDED|95.0|-11.778|-5.394|||ANCOVA|||Change from Baseline to Week 4||-5.394|-11.778|<0.001
71867396|NCT03001076|143251734|SUPERIORITY||Difference in LS mean|-6.42|STANDARD_ERROR_OF_MEAN|1.712|<|0.001|TWO_SIDED|95.0|-9.798|-3.049|||ANCOVA|||Change from Baseline to Week 8||-3.049|-9.798|<0.001
71867397|NCT00293059|143251758|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||inverting 2 one-sided tests|||||||< 0.0001
71867398|NCT00878826|143251845|SUPERIORITY_OR_OTHER|||||||0.4|||||||Kruskal-Wallis|||at 14-18 weeks gestational age||||0.4
71867399|NCT00878826|143251845|SUPERIORITY_OR_OTHER|||||||0.9|||||||Kruskal-Wallis|||at 24-28 weeks gestational age||||0.9
71867400|NCT00878826|143251845|SUPERIORITY_OR_OTHER|||||||0.3|||||||Kruskal-Wallis|||at 32-34 weeks gestational age||||0.3
71867401|NCT05453201|143251889|OTHER|||||||0.06|||||||paired t-test|||This analysis uses the functional disability subscale from pre- to post-intervention.||||.06
71867402|NCT05453201|143251889|OTHER|||||||0.004|||||||paired t-test|||This analysis uses the symptom severity subscale from pre- to post-intervention.||||.004
71867403|NCT05453201|143251889|OTHER|||||||0.1|||||||paired t-test|||This analysis uses the perceived overall health now subscale (1 item) from pre- to post-intervention.||||.10
71867404|NCT05453201|143251890|OTHER|||||||0.46|||||||paired t-test|||This analysis uses domain 1 from pre- to post-intervention.||||.46
71867405|NCT05453201|143251890|OTHER|||||||0.2|||||||paired t-test|||This analysis uses domain 2 from pre- to post-intervention.||||.20
71867406|NCT05453201|143251890|OTHER|||||||0.42|||||||paired t-test|||This analysis uses domain 3 from pre- to post-intervention.||||.42
71867407|NCT05453201|143251890|OTHER|||||||0.84|||||||paired t-test|||This analysis uses domain 4 from pre- to post-intervention.||||.84
71867408|NCT05453201|143251890|OTHER|||||||0.25|||||||paired t-test|||This analysis uses domain 5 (part 1) from pre- to post-intervention.||||.25
71867409|NCT05453201|143251890|OTHER|||||||0.26|||||||paired t-test|||This analysis uses domain 6 from pre- to post-intervention.||||.26
71867410|NCT05453201|143251891|OTHER|||||||0.89|||||||Wilcoxon test|||This analysis uses the SBQ-R total score from pre- to post-intervention.||||.89
71867411|NCT05453201|143251892|OTHER|||||||0.8|||||||paired t-test|||This analysis uses the MOCS (part A) from pre- to post-intervention.||||.80
71867412|NCT05453201|143251893|OTHER|||||||0.92|||||||paired t-test|||This analysis uses the FSCQ score (all items) from pre- to post-intervention.||||.92
71867413|NCT05453201|143251893|OTHER|||||||0.9|||||||Wilcoxon test (paired)|||This analysis uses the FSCQ similarity subscale from pre- to post-intervention.||||.90
71867414|NCT05453201|143251893|OTHER|||||||0.74|||||||paired t-test|||This analysis uses the FSCQ vividness subscale from pre- to post-intervention.||||.74
71867415|NCT05453201|143251893|OTHER|||||||0.44|||||||paired t-test|||This analysis uses the FSCQ positivity subscale from pre- to post-intervention.||||.44
71867416|NCT05453201|143251894|OTHER|||||||0.003|||||||paired t-test|||This analysis uses the PHQ-9 from pre- to post-intervention.||||.003
71867417|NCT05453201|143251895|OTHER|||||||0.01|||||||paired t-test|||This analysis uses the GAD-7 from pre- to post-intervention.||||.01
71867418|NCT05453201|143251896|OTHER|||||||0.04|||||||paired t-test|||This analysis uses the QOLS from pre- to post-intervention.||||.04
71867419|NCT05453201|143251897|OTHER|"The AIM measures an intervention's acceptability. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention acceptability. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the AIM at pre- and post-intervention."||||||0.24|||||||Paired t-test|||||||.24
71867420|NCT05453201|143251897|OTHER|"The IAM measures an intervention's appropriateness. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention appropriateness. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the IAM at pre- and post-intervention."||||||0.82|||||||Paired t-test|||||||.82
71867421|NCT05453201|143251897|OTHER|||||||0.38|||||||Paired t-test|||"The FIM measures an intervention's feasibility. Therefore, the goal is not change over time, the goal is to assess, descriptively, post-intervention feasibility. Because we assessed this measure at baseline (with expectations of the future treatment), we provide a paired t-test with the FIM at pre- and post-intervention."||||.38
71867422|NCT04688320|143251902|NON_INFERIORITY|The margin of the non-inferiority was established as a difference in the primary efficacy endpoints between compared groups|Odds Ratio (OR)|0.75|||<|0.05|TWO_SIDED|95.0|0.11|4.52|||Welch's t-test|||||4.52|0.11|<0.05
71867423|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.324|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.324
71867424|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.031
71867425|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.076|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.076
71867426|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.013
71867427|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.553
71867428|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.132
71867429|NCT01200290|143251916|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.230
71867430|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.335|TWO_SIDED|||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement|||||||0.335
71867431|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED|||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement|||||||0.043
71867432|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.073|TWO_SIDED|||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement|||||||0.073
71867433|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement|||||||0.004
71867434|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED|||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement|||||||0.699
71867435|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.095|TWO_SIDED|||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement|||||||0.095
71867436|NCT01200290|143251917|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED|||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement|||||||0.082
71867437|NCT00728910|143251924|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that the sequential addition of a fibrate and niacin to baseline atorvastatin therapy would not have any effect on apo-AI catabolism.||||>0.5
71867438|NCT00728910|143251925|SUPERIORITY_OR_OTHER||||||>|0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on apo-A1 production rates||||>0.5
71867439|NCT00728910|143251926|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||Null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on post-prandial triglyceride levels following an oral fat load||||<0.0005
71867440|NCT00728910|143251926|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0005
71682830|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|38.72||||0.042|TWO_SIDED|95.0|1.41|76.02|||repeated measures model||Week 21|||76.02|1.41|0.042
71867441|NCT04155203|143251927|EQUIVALENCE|The primary efficacy endpoint was the proportion of subjects in each treatment group with clinical cure, defined as a SIRS score of 0 for all signs and symptoms at Visit 4/Follow-up (7 days after the end of treatment).|equivalence ratio|0.97|||||TWO_SIDED|90.0|-8.19|2.7||||||||2.70|-8.19|
71911812|NCT02940860|143344085|SUPERIORITY||Mean Difference (Final Values)|8.8|||<|0.0001|TWO_SIDED|95.0|6.9|10.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||10.7|6.9|<0.0001
71911813|NCT02940860|143344085|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.0129|TWO_SIDED|95.0|0.3|2.4|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||2.4|0.3|0.0129
71911814|NCT02940860|143344085|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.2403|TWO_SIDED|95.0|-0.4|1.5|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.5|-0.4|0.2403
71911815|NCT02940860|143344085|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8094|TWO_SIDED|95.0|-0.9|1.2|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."||1.2|-0.9|0.8094
71867442|NCT02489968|143251934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.97|-0.67|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)|||-0.67|-0.97|<0.0001
71867443|NCT02489968|143251934|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.73|-0.45|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)|||-0.45|-0.73|<0.0001
71867444|NCT01241604|143251941|EQUIVALENCE|Equivalent non-parametric tests||||||0.753|||||||Wilcoxon signed ranks test|||||||.753
71867445|NCT01865747|143251978|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Log Rank|The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.||||0.74|0.45|<0.0001
71867446|NCT01865747|143251979|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.53|0.83|||Log Rank|The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.||||0.83|0.53|0.0003
71867447|NCT01865747|143251980|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71867448|NCT03465904|143251987|SUPERIORITY|Our power analysis indicated that a minimum of 239 patients per group was needed to provide 90% power to detect a 13.4% difference in the primary outcome, pain freedom at 2 h. Accounting for an estimated attrition rate of 20%, we aimed to enroll 299 patients per group.|||||<|0.05||||||All analyses were performed using SPSS, version 26.0 with two-sided levels of statistical significance established at p \< 0.05|Chi-squared|A Chi-square test of independent proportions was used to compare primary and secondary efficacy outcomes between groups.||Identical statistical analyses were performed for the intent-to-treat (ITT) and the per protocol (PP) populations. The ITT population consisted of all randomized patients, who received any duration of sham or verum treatment and returned completed study materials. The PP population consisted of patients who strictly met inclusion criteria and completed at least 60 min of treatment.||||<0.05
71867449|NCT01209234|143252008|SUPERIORITY||Cox Proportional Hazard|0.7|STANDARD_ERROR_OF_MEAN|0.024||0.026|TWO_SIDED|95.0|0.52|0.96|||Regression, Cox||This is the estimated standard error of the log hazard ratio|||0.96|0.52|0.026
71867450|NCT01209234|143252009|SUPERIORITY||Cox Proportional Hazard|0.84|STANDARD_ERROR_OF_MEAN|0.009||0.061|TWO_SIDED|95.0|0.7|1.01||Not adjusted for multiple comparisons|Regression, Cox||CDC-defined all-cause infection secondary outcome This is the estimated standard error of the log hazard ratio|||1.01|0.70|0.061
71867451|NCT01209234|143252009|SUPERIORITY||Cox Proportional Hazard|0.83|STANDARD_ERROR_OF_MEAN|0.008||0.035|TWO_SIDED|95.0|0.7|0.99||Not adjusted for multiple comparisons|Regression, Cox||Clinical criteria for all-cause infection This is the estimated standard error of the log hazard ratio|||0.99|0.70|0.035
71867452|NCT00591721|143252041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.53|STANDARD_DEVIATION|6.47|<|0.05|TWO_SIDED|95.0|-15.47|10.41|||t-test, 2 sided|Each baseline subscale score was subtracted from 7 week subscale score; t-tests assessed mean individual differences between groups.||Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.||10.41|-15.47|<0.05
71682831|NCT01362244|142883808|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.13||||0.484|TWO_SIDED|95.0|-25.76|54.02|||repeated measures model||Week 25|||54.02|-25.76|0.484
71682832|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.16||||0.005|TWO_SIDED|95.0|6.49|35.83|||repeated measures model||Week 2|||35.83|6.49|0.005
71867453|NCT02716818|143252046|SUPERIORITY||Mean Difference (Final Values)|-0.069|||=|0.5521|TWO_SIDED|95.0|-0.299|0.161|||ANCOVA|||The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS profile for the natural logarithm of 17-OHP. The SDS profile was calculated as the SDS of log transformed 17-OHP concentration unsigned. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs, with the first and last (13th) weighted one half relative to the intermediate SDSs.||0.161|-0.299|=0.5521
71867454|NCT02716818|143252047|SUPERIORITY||Mean Difference (Final Values)|0.047|||=|0.7405|TWO_SIDED|95.0|-0.234|0.329|||ANCOVA|||Change from Baseline to 24 Weeks in A4 Using an ANCOVA Model - The analysis conducted for the primary endpoint variable analysis of 17-OHP was repeated for A4.||0.329|-0.234|=0.7405
71867455|NCT02716818|143252048|SUPERIORITY||Mean Difference (Final Values)|-0.037|||=|0.8186|TWO_SIDED|95.0|-0.354|0.281|||ANCOVA|||||0.281|-0.354|=0.8186
71867456|NCT02716818|143252048|SUPERIORITY||Mean Difference (Final Values)|-0.135|||=|0.4655|TWO_SIDED|95.0|-0.508|0.237|||ANCOVA|||||0.237|-0.508|=0.4655
71867457|NCT02716818|143252048|SUPERIORITY||Mean Difference (Final Values)|0.065|||=|0.9081|TWO_SIDED|95.0|-1.32|1.451|||ANCOVA|||||1.451|-1.32|=0.9081
71867458|NCT02716818|143252048|SUPERIORITY||Median Difference (Final Values)|0.092|||=|0.6729|TWO_SIDED|95.0|-0.343|0.527|||ANCOVA|||||0.527|-0.343|=0.6729
71867459|NCT02716818|143252048|SUPERIORITY||Mean Difference (Final Values)|0.116|||=|0.5322|TWO_SIDED|95.0|-0.257|0.489|||ANCOVA|||||0.489|-0.257|=0.5322
71867460|NCT02716818|143252048|SUPERIORITY||Mean Difference (Final Values)|-0.568|||=|0.2885|TWO_SIDED|95.0|-1.799|0.662|||ANCOVA|||||0.662|-1.799|=0.2885
71867461|NCT02716818|143252049|SUPERIORITY||Odds Ratio (OR)|0.99|||=|0.9877|TWO_SIDED|95.0|0.45|2.19|||Regression, Logistic|||||2.19|0.45|=0.9877
71867462|NCT02716818|143252049|SUPERIORITY||Odds Ratio (OR)|0.93|||=|0.8498|TWO_SIDED|95.0|0.43|2.02|||Regression, Logistic|||||2.02|0.43|=0.8498
71867463|NCT02716818|143252050|SUPERIORITY||Mean Difference (Final Values)|-0.96|||=|0.156|TWO_SIDED|95.0|-2.294|0.374|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||0.374|-2.294|=0.156
71867464|NCT02716818|143252050|SUPERIORITY||Median Difference (Final Values)|0.425|||=|0.3392|TWO_SIDED|95.0|-0.455|1.305|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.||1.305|-0.455|=0.3392
71867465|NCT02716818|143252051|SUPERIORITY||Median Difference (Final Values)|0.009|||=|0.2614|TWO_SIDED|95.0|-0.007|0.025|||ANCOVA|||||0.025|-0.007|=0.2614
71867466|NCT00581555|143252060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|7.5||0.999|TWO_SIDED|95.0|-14.7|14.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 8.||14.7|-14.7|0.999
71867467|NCT00581555|143252060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|7.5||0.795|TWO_SIDED|95.0|-12.8|16.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 10.||16.7|-12.8|0.795
71867468|NCT00581555|143252060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|7.6||0.758|TWO_SIDED|95.0|-12.5|17.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 12.||17.1|-12.5|0.758
71867469|NCT00581555|143252060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|STANDARD_ERROR_OF_MEAN|7.6||0.381|TWO_SIDED|95.0|-8.3|21.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 16.||21.6|-8.3|0.381
71867470|NCT00581555|143252060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|7.8||0.041|TWO_SIDED|95.0|0.8|31.4||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis at randomization to Week 20.||31.4|0.8|0.041
71867471|NCT00581555|143252060|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.5|STANDARD_ERROR_OF_MEAN|8.0|<|0.001|TWO_SIDED|95.0|14.8|46.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 24.||46.3|14.8|<0.001
71867472|NCT00581555|143252061|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.049|TWO_SIDED|95.0|0.0|1.2||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||1.2|0.0|0.049
71867473|NCT00581555|143252062|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from randomization to Week 24.||||0.002
71867474|NCT00581555|143252063|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||Log Rank|Time to first relapse was estimated using the Kaplan-Meier's, and comparisons between groups was performed using log rank tests.||||||0.0003
71867475|NCT00581555|143252064|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|2.1|7.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||7.3|2.1|<0.001
71867476|NCT00581555|143252065|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|135.2|STANDARD_ERROR_OF_MEAN|42.3||0.001|TWO_SIDED|95.0|52.3|218.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||218.1|52.3|0.001
71682833|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.89||||0.029|TWO_SIDED|95.0|1.77|32.01|||repeated measures model||Week 5|||32.01|1.77|0.029
71867477|NCT00581555|143252066|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.6||0.139||95.0|-0.8|5.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.||5.5|-0.8|0.139
71682834|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.2||||0.472|TWO_SIDED|95.0|-12.64|27.03|||repeated measures model||Week 9|||27.03|-12.64|0.472
71682835|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.71||||0.009|TWO_SIDED|95.0|7.19|48.23|||repeated measures model||Week 13|||48.23|7.19|0.009
71867478|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.956|TWO_SIDED|95.0|-2.3|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 2.||2.5|-2.3|0.956
71867479|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.41|TWO_SIDED|95.0|-3.6|1.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 4.||1.5|-3.6|0.41
71867480|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|2.2||0.844|TWO_SIDED|95.0|-4.8|3.9||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 6.||3.9|-4.8|0.844
71867481|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.9||0.968|TWO_SIDED|95.0|-1.8|1.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 8.||1.8|-1.8|0.968
71867482|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.9||0.441|TWO_SIDED|95.0|-1.1|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 10.||2.5|-1.1|0.441
71867483|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.9||0.3|TWO_SIDED|95.0|-0.9|2.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 12.||2.8|-0.9|0.3
71867484|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|0.7|4.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 16.||4.5|0.7|0.008
71867485|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|1.0||0.005|TWO_SIDED|95.0|0.9|5.0||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 20.||5.0|0.9|0.005
71867486|NCT00581555|143252067|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.1||0.031|TWO_SIDED|95.0|0.2|4.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 24.||4.6|0.2|0.031
71867487|NCT00581555|143252068|SUPERIORITY_OR_OTHER|||||||0.1196||95.0||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square or Fisher exact test|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from baseline to Week 24.||||0.1196
71867488|NCT03828747|143252069|SUPERIORITY||Least Squares Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|0.849||0.0008|TWO_SIDED|95.0|-4.56|-1.21|||Mixed Models Analysis|||Change from Baseline at Week 49||-1.21|-4.56|0.0008
71867489|NCT03828747|143252069|SUPERIORITY||Least Squares Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|1.287||0.0351|TWO_SIDED|95.0|-5.31|-0.2|||Mixed Models Analysis|||Change from Baseline at Week 61||-0.20|-5.31|0.0351
71867490|NCT03828747|143252070|SUPERIORITY||Least Squares Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.295||0.5207||95.0|-3.39|1.72|||Mixed Models Analysis|||Change from Baseline at Week 49||1.72|-3.39|0.5207
71867491|NCT03828747|143252070|SUPERIORITY||Least Squares Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|1.911||0.3704||95.0|-5.5|2.07|||Mixed Models Analysis|||Change from Baseline at Week 61||2.07|-5.50|0.3704
71867492|NCT03828747|143252071|SUPERIORITY||Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.282||0.3501||95.0|-0.29|0.82|||Mixed Models Analysis|||Change from Baseline at Week 49||0.82|-0.29|0.3501
71867493|NCT03828747|143252071|SUPERIORITY||Least Squares Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.525||0.7431|TWO_SIDED|95.0|-0.87|1.22|||Mixed Models Analysis|||Change from Baseline at Week 61||1.22|-0.87|0.7431
71867494|NCT03828747|143252072|SUPERIORITY||Least Squares Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.429||0.5366||95.0|-0.58|1.11|||Mixed Models Analysis|||Change from Baseline at Week 49||1.11|-0.58|0.5366
71867495|NCT03828747|143252072|SUPERIORITY||Least Squares Mean Difference|1.08|STANDARD_ERROR_OF_MEAN|0.618||0.0851||95.0|-0.15|2.3|||Mixed Models Analysis|||Change from Baseline at Week 61||2.30|-0.15|0.0851
71867496|NCT00700427|143252169|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
71867497|NCT00700427|143252171|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
71867498|NCT00700427|143252172|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
71867499|NCT00700427|143252172|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||0.002
71867500|NCT00700427|143252172|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||0.009
71867501|NCT00700427|143252172|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||0.003
71867502|NCT00700427|143252173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA|||||||<0.001
71867503|NCT00700427|143252173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA|||||||<0.001
71867504|NCT00700427|143252173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Inattention Subscale Imputed Score.|ANCOVA|||||||<0.001
71867505|NCT00700427|143252173|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA|||||||<0.001
71867506|NCT00700427|143252174|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
71867507|NCT00700427|143252175|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANCOVA|||||||0.006
71867508|NCT00355199|143252182|SUPERIORITY||Hazard Ratio (HR)|0.99|||<|0.05|TWO_SIDED|95.0|0.66|1.48|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.48|0.66|<0.05
71682836|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4||||0.114|TWO_SIDED|95.0|-3.8|34.59|||repeated measures model||Week 17|||34.59|-3.80|0.114
71867509|NCT00355199|143252184|SUPERIORITY||Hazard Ratio (HR)|0.6|||<|0.05|TWO_SIDED|95.0|0.29|1.21|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.21|0.29|<0.05
71867510|NCT00355199|143252185|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.57|1.52|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)|||1.52|0.57|<0.05
71867511|NCT02503852|143252189|SUPERIORITY|||||||0.032|||||||ANCOVA|||||||0.032
71867512|NCT02503852|143252189|OTHER|||||||0.0318||||||P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24|ANCOVA|||Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.||||0.0318
71867513|NCT03231800|143252191|SUPERIORITY||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.059|<|0.001|TWO_SIDED|95.0|-7.351|-3.137|||ANCOVA|||Least squares means, SEs, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects.||-3.137|-7.351|<0.001
71867514|NCT03231800|143252194|SUPERIORITY||Mean Difference (Final Values)|13.86|STANDARD_ERROR_OF_MEAN|5.612||0.016|TWO_SIDED|95.0|2.694|25.017|||ANCOVA|||||25.017|2.694|0.016
71867515|NCT03231800|143252195|SUPERIORITY||Mean Difference (Final Values)|12.06|STANDARD_ERROR_OF_MEAN|5.508||0.031|TWO_SIDED|95.0|1.105|23.017|||ANCOVA|||||23.017|1.105|0.031
71867516|NCT01670760|143252214|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.69||||0.69|TWO_SIDED||||||ANOVA|||||||0.69
71867517|NCT00741390|143252220|SUPERIORITY_OR_OTHER||Percentage|99.59||||||95.0|98.09|99.59||||||||99.59|98.09|
71867518|NCT00741390|143252220|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|98.79|100.0||||||||100|98.79|
71867519|NCT00741390|143252220|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|97.61|100.0||||||||100|97.61|
71867520|NCT00741390|143252220|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.36|100.0||||||||100|95.36|
71867521|NCT00741390|143252220|SUPERIORITY_OR_OTHER||Percentage|100.0||||||95.0|95.13|100.0||||||||100|95.13|
71682837|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.51||||0.014|TWO_SIDED|95.0|6.06|52.96|||repeated measures model||Week 21|||52.96|6.06|0.014
71867522|NCT00741390|143252221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.84|||<|0.001||95.0|6.8|10.84|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||10.84|6.80|<0.001
71867523|NCT00741390|143252221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.55||||0.003||95.0|3.63|8.55|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||8.55|3.63|0.003
71867524|NCT00741390|143252221|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23||||0.46||95.0|-3.57|0.23|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||0.23|-3.57|0.460
71867525|NCT00741390|143252222|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.9||||0.017||95.0|1.14|4.9|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.||||4.90|1.14|0.017
71867526|NCT00741390|143252223|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.001
71867527|NCT00741390|143252223|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.002
71867528|NCT00741390|143252223|SUPERIORITY_OR_OTHER|||||||0.761||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.761
71682838|NCT01362244|142883810|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.65||||0.027|TWO_SIDED|95.0|3.1|50.21|||repeated measures model||Week 25|||50.21|3.10|0.027
71867529|NCT00741390|143252223|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.||||0.004
71867530|NCT01056718|143252249|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.||||<0.05
71867531|NCT01056718|143252250|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867532|NCT01056718|143252251|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867533|NCT01056718|143252252|SUPERIORITY_OR_OTHER||||||=|0.078|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.078
71867534|NCT01056718|143252253|SUPERIORITY_OR_OTHER||||||=|0.186|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.186
71867535|NCT01056718|143252254|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867536|NCT01056718|143252255|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867537|NCT01056718|143252256|SUPERIORITY_OR_OTHER||||||=|0.06|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.06
71867538|NCT01056718|143252257|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867539|NCT01056718|143252258|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867540|NCT01056718|143252259|SUPERIORITY_OR_OTHER||||||=|0.85|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.85
71867541|NCT01056718|143252260|SUPERIORITY_OR_OTHER||||||=|0.4|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.40
71867542|NCT01056718|143252261|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
71867543|NCT01056718|143252262|SUPERIORITY_OR_OTHER||||||=|0.49|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.49
71867544|NCT01056718|143252263|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.47
71867545|NCT01056718|143252264|SUPERIORITY_OR_OTHER||||||=|0.55|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.55
71867546|NCT01056718|143252265|SUPERIORITY_OR_OTHER||||||=|0.64|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=0.64
71867547|NCT01056718|143252266|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71911816|NCT02940860|143344086|SUPERIORITY||Mean Difference (Final Values)|26.5|||<|0.0001|TWO_SIDED|95.0|20.4|32.7|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||32.7|20.4|<0.0001
71911817|NCT02940860|143344086|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.2229|TWO_SIDED|95.0|-1.2|5.1|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||5.1|-1.2|0.2229
71911818|NCT02940860|143344086|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.9046|TWO_SIDED|95.0|-2.9|2.6|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||2.6|-2.9|0.9046
71911819|NCT02940860|143344086|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.1307|TWO_SIDED|95.0|-5.8|0.8|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."||0.8|-5.8|0.1307
71911820|NCT02940860|143344087|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8196|TWO_SIDED|95.0|-0.73|0.92|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.92|-0.73|0.8196
71911821|NCT02940860|143344087|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.7132|TWO_SIDED|95.0|-1.06|0.73|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||0.73|-1.06|0.7132
71911822|NCT02940860|143344087|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.586|TWO_SIDED|95.0|-0.71|1.25|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."||1.25|-0.71|0.5860
71911823|NCT04914819|143344093|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.048|TWO_SIDED|95.0|0.04|10.8|||Mixed Models Analysis|||Change in weight among participants who completed final assessment||10.8|0.04|0.048
71911824|NCT04914819|143344094|SUPERIORITY|||||||0.3|||||||Chi-squared|||||||0.3
71911825|NCT04914819|143344095|SUPERIORITY|||||||0.331|||||||Chi-squared|||||||0.331
71911826|NCT04914819|143344096|SUPERIORITY|||||||0.734|||||||Fisher Exact|||||||0.734
71867548|NCT01056718|143252267|SUPERIORITY_OR_OTHER||||||=|0.526|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.526
71911827|NCT04038385|143344108|SUPERIORITY||Mean Difference (Net)|-42.87||||0.001|TWO_SIDED|95.0|-65.25|-20.49|||Mixed Models Analysis|||||-20.49|-65.25|0.001
71911828|NCT04038385|143344109|SUPERIORITY||Median Difference (Net)|23.91||||0.031|TWO_SIDED|95.0|2.21|45.62|||Mixed Models Analysis|||||45.62|2.21|0.031
71911829|NCT04038385|143344110|SUPERIORITY||Median Difference (Net)|-0.06||||0.662|TWO_SIDED|95.0|-0.33|0.21|||Mixed Models Analysis|||||0.21|-0.33|0.662
71911830|NCT04038385|143344111|SUPERIORITY||Mean Difference (Net)|0.28||||0.047|TWO_SIDED|95.0|0.0|0.55|||Mixed Models Analysis|||||0.55|0.00|0.047
71867549|NCT01056718|143252268|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71867550|NCT01056718|143252269|SUPERIORITY_OR_OTHER||||||=|0.925|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.925
71867551|NCT01056718|143252270|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||<0.05
71911831|NCT04038385|143344112|SUPERIORITY||Odds Ratio (OR)|17.39|||<|0.01|TWO_SIDED|95.0|8.64|35.02|||Regression, Logistic|||||35.02|8.64|<0.01
71911832|NCT04038385|143344113|SUPERIORITY||Odds Ratio (OR)|3.9||||0.056|TWO_SIDED|95.0|1.0|16.1|||Mixed Models Analysis|||||16.1|1.0|0.056
71911833|NCT04038385|143344114|SUPERIORITY||Odds Ratio (OR)|4.0||||0.05|TWO_SIDED|95.0|1.0|16.3|||Mixed Models Analysis|||||16.3|1.0|0.050
71911834|NCT04038385|143344115|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.5|-1.0|||Mixed Models Analysis|||||-1.0|-2.5|0.001
71911835|NCT04038385|143344116|SUPERIORITY||Median Difference (Net)|-0.7||||0.082|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|||||0.1|-1.4|0.082
71911836|NCT04038385|143344117|SUPERIORITY||Mean Difference (Net)|-1.5||||0.001|TWO_SIDED|95.0|-2.2|-0.8|||Mixed Models Analysis|||||-0.8|-2.2|0.001
71911837|NCT04038385|143344118|SUPERIORITY||Median Difference (Net)|-0.7||||0.039|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|||||-0.0|-1.4|0.039
71911838|NCT04038385|143344119|SUPERIORITY||Mean Difference (Net)|0.0||||0.962|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.962
71911839|NCT04038385|143344120|SUPERIORITY||Mean Difference (Net)|-0.2||||0.277|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|.277
71911840|NCT04038385|143344121|SUPERIORITY||Median Difference (Net)|-0.4||||0.155|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis|||||0.2|-1.0|0.155
71911841|NCT04038385|143344122|SUPERIORITY||Mean Difference (Net)|0.1||||0.74|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||||0.7|-0.5|0.740
71911842|NCT04038385|143344123|SUPERIORITY||Median Difference (Net)|-0.2||||0.122|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.122
71911843|NCT04038385|143344124|SUPERIORITY||Mean Difference (Net)|-0.2||||0.177|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|.177
71911844|NCT04038385|143344125|SUPERIORITY||Median Difference (Net)|0.1||||0.514|TWO_SIDED|95.0|-0.3|0.5|||Mixed Models Analysis|||||0.5|-0.3|0.514
71911845|NCT04038385|143344126|SUPERIORITY||Median Difference (Net)|0.2||||0.335|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.335
71911846|NCT04038385|143344127|SUPERIORITY||Mean Difference (Net)|0.1||||0.75|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||||0.6|-0.4|0.750
71911847|NCT04038385|143344128|SUPERIORITY||Mean Difference (Net)|-0.2||||0.455|TWO_SIDED|95.0|-0.7|0.3|||Mixed Models Analysis|||||0.3|-0.7|0.455
71911848|NCT04038385|143344129|SUPERIORITY||Mean Difference (Net)|0.9||||0.053|TWO_SIDED|95.0|0.0|1.8|||Mixed Models Analysis|||||1.8|-0.0|0.053
71911849|NCT04038385|143344130|SUPERIORITY||Mean Difference (Net)|0.0||||0.986|TWO_SIDED|95.0|-0.9|0.9|||Mixed Models Analysis|||||0.9|-0.9|.986
71911850|NCT04038385|143344131|SUPERIORITY||Odds Ratio (OR)|1.1||||0.81|TWO_SIDED|95.0|0.6|2.2|||Mixed Models Analysis|||||2.2|0.6|0.810
71911851|NCT04038385|143344132|SUPERIORITY||Odds Ratio (OR)|0.8||||0.591|TWO_SIDED|95.0|0.4|1.7|||Mixed Models Analysis|||||1.7|0.4|0.591
71911852|NCT03961295|143344136|OTHER||Ratio of Geometric LSMs|1.2984|||||TWO_SIDED|90.0|1.0786|1.5486||||||Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5486|1.0786|
71911853|NCT03961295|143344137|OTHER||Ratio of Geometric LSMs|1.3274|||||TWO_SIDED|90.0|1.1147|1.5807||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.5807|1.1147|
71911854|NCT03961295|143344138|OTHER||Ratio of Geometric LSMs|1.1978|||||TWO_SIDED|90.0|1.0394|1.3804||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.||1.3804|1.0394|
71911855|NCT02657434|143344180|OTHER|Unstratified Analysis|Hazard Ratio, log|0.562|||<|0.0001|TWO_SIDED|95.0|0.471|0.671|||Log Rank|||||0.671|0.471|<0.0001
71911856|NCT02657434|143344181|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.866||||0.1559|TWO_SIDED|95.0|0.709|1.056|||Log Rank|||||1.056|0.709|0.1559
71911857|NCT02657434|143344181|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.864||||0.1546|TWO_SIDED|95.0|0.707|1.056|||Log Rank|||||1.056|0.707|0.1546
71911858|NCT02657434|143344182|SUPERIORITY||Difference in event free rate|4.68||||0.2606|TWO_SIDED|95.0|-3.47|12.83|||z test|||||12.83|-3.47|0.2606
71911859|NCT02657434|143344183|SUPERIORITY||Difference in Event Free Rate|5.12||||0.209|TWO_SIDED|95.0|-2.87|13.11|||Z-test|||||13.11|-2.87|0.2090
71911860|NCT02657434|143344184|SUPERIORITY||Difference in response rate|14.3||||0.0005|TWO_SIDED|95.0|5.9|22.7|||Cochran-Mantel-Haenszel|||||22.7|5.9|0.0005
71911861|NCT02657434|143344185|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.0024|TWO_SIDED|95.0|0.45|0.85|||Log Rank|||||0.85|0.45|0.0024
71911862|NCT00608881|143344195|SUPERIORITY_OR_OTHER||π hat|0.494|||||TWO_SIDED|95.0|0.454|0.534|||||π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.|In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.||0.534|0.454|
71911863|NCT00608881|143344196|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|-0.44|0.91||||||||0.91|-0.44|
71911864|NCT00608881|143344197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|||||TWO_SIDED|95.0|-1.4|1.58||||||||1.58|-1.40|
71911865|NCT00608881|143344198|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.44|||||TWO_SIDED|95.0|-6.68|3.79||||||||3.79|-6.68|
71911866|NCT00608881|143344199|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|||||TWO_SIDED|95.0|-4.4|2.16||||||||2.16|-4.40|
71911867|NCT00608881|143344200|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-1.48|1.39||||||||1.39|-1.48|
71911868|NCT00608881|143344201|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|||||TWO_SIDED|95.0|-4.78|3.23||||||||3.23|-4.78|
71911869|NCT00608881|143344202|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||||TWO_SIDED|95.0|-1.32|2.14||||||||2.14|-1.32|
71911870|NCT00608881|143344203|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.71|1.51||||||||1.51|-2.71|
71911871|NCT00608881|143344204|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|||||TWO_SIDED|95.0|-2.28|2.87||||||||2.87|-2.28|
71911872|NCT00608881|143344205|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.88|||||TWO_SIDED|95.0|0.31|7.44||||||||7.44|0.31|
71911873|NCT00608881|143344206|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|-1.1|3.18||||||||3.18|-1.10|
71911874|NCT00608881|143344207|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.81|1.2||||||||1.20|0.81|
71911875|NCT00608881|143344208|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.75|1.15||||||||1.15|0.75|
71911876|NCT00810043|143344232|SUPERIORITY_OR_OTHER|||||||0.43|||||||t-test, 2 sided|||Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.430
71911877|NCT00810043|143344232|SUPERIORITY_OR_OTHER|||||||0.643|||||||t-test, 2 sided|||Middle vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.643
71911878|NCT00810043|143344232|SUPERIORITY_OR_OTHER|||||||0.165|||||||t-test, 2 sided|||Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)||||0.165
71911879|NCT00810043|143344233|SUPERIORITY_OR_OTHER|||||||0.402|||||||t-test, 2 sided|||Anterior VBH restored||||0.402
71911880|NCT00810043|143344233|SUPERIORITY_OR_OTHER|||||||0.578|||||||t-test, 2 sided|||Middle VBH restored||||0.578
71911881|NCT00810043|143344233|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Posterior VBH restored||||0.166
71911882|NCT00810043|143344235|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||Anterior VBH gained by postural reduction||||0.900
71911883|NCT00810043|143344235|SUPERIORITY_OR_OTHER|||||||0.62|||||||t-test, 2 sided|||Middle VBH gained by postural reduction||||0.620
71911884|NCT00810043|143344235|SUPERIORITY_OR_OTHER|||||||0.349|||||||t-test, 2 sided|||Posterior VBH gained by postural reduction||||0.349
71911885|NCT00810043|143344236|SUPERIORITY_OR_OTHER|||||||0.889|||||||t-test, 2 sided|||||||0.889
71911886|NCT00810043|143344237|SUPERIORITY_OR_OTHER|||||||0.486|||||||t-test, 2 sided|||||||0.486
71911887|NCT00810043|143344238|SUPERIORITY_OR_OTHER|||||||0.144|||||||t-test, 2 sided|||||||0.144
71911888|NCT00810043|143344239|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.360
71911889|NCT01989754|143344240|SUPERIORITY||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.57|0.73|||Cox proportional hazard method|||||0.73|0.57|<.0001
71682839|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09||||0.79|TWO_SIDED|95.0|-0.61|0.79|||repeated measures model||MNS, Week 2|||0.79|-0.61|0.790
71911890|NCT01989754|143344241|SUPERIORITY||Hazard Ratio (HR)|0.72|||=|0.0148|TWO_SIDED|95.0|0.55|0.94|||Stratified Cox proportional hazard|||||0.94|0.55|=0.0148
71911891|NCT01989754|143344242|SUPERIORITY||Hazard Ratio (HR)|0.86|||=|0.4067|TWO_SIDED|95.0|0.61|1.22|||Stratified Cox proportional hazard|||||1.22|0.61|=0.4067
71911892|NCT03364491|143344253|SUPERIORITY|Model included treatment and preoperative hemoglobin level \<8 g/dL (yes/no) as covariates. We estimated that a total sample size of 11,000 participants (5,500 per group) would achieve 85% power to detect a 33% lower incidence of the primary outcome (1.67%) in the TXA group, at a type I error rate (two-sided) of 5%.|Risk Ratio (RR)|0.89||||0.19|TWO_SIDED|95.26|0.74|1.07||Following two interim analyses, a two-tailed P value of less than 0.047 was considered to indicate statistical significance.|Other (Log-binomial regression model)|||||1.07|0.74|0.19
71911893|NCT00294684|143344276|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.14||||0.43|TWO_SIDED|95.0|0.83|1.57|||Log binomial|||RR greater than one indicates benefit of steriods and a P value of treatment success from a log-binomial model with these covariates: Treatment group, age a HPE, BASM as fixed effects, and site as a random effect.||1.57|0.83|0.43
71682840|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14||||0.008|TWO_SIDED|95.0|0.3|1.97|||repeated measures model||MNS, Week 5|||1.97|0.30|0.008
71911894|NCT00294684|143344277|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED|95.0|0.6|1.8|||Regression, Cox|||||1.8|0.6|0.99
71911895|NCT00294684|143344278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6||||0.0973|TWO_SIDED|95.0|-3.49|0.3|||Mixed Models Analysis|||LS Mean difference reported as steroid minus placebo (negative values mean larger average values of total bilirubin in placebo).||0.3|-3.49|0.0973
71911896|NCT00294684|143344279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.3||||0.0552|TWO_SIDED|95.0|-4.65|0.05|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average values of bilirubin in placebo)||0.05|-4.65|0.0552
71911897|NCT00294684|143344280|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.39||||0.6607||95.0|-2.16|1.38|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average bilirubin in placebo)||1.38|-2.16|0.6607
71911898|NCT00294684|143344281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1603|||||||Mixed Models Analysis|||||||0.1603
71911899|NCT00294684|143344282|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2801|||||||Mixed Models Analysis|||||||0.2801
71911900|NCT00294684|143344283|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.4||||0.41|TWO_SIDED|95.0|0.62|3.14|||Log Binomial|||||3.14|0.62|0.41
71911901|NCT00294684|143344284|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.3||||0.29|TWO_SIDED|95.0|0.03|2.92|||Log Binomial|||||2.92|0.03|0.29
71911902|NCT01150760|143344322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0007|||||||Chi-squared|||||||0.0007
71911903|NCT01150760|143344323|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.9|||<|0.0001|||||||Chi-squared|||||||< 0.0001
71911904|NCT01150760|143344324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.0001|||||||Chi-squared|||||||0.0001
71911905|NCT01150760|143344325|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.1022|||||||Chi-squared|||||||0.1022
71911906|NCT01150760|143344326|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||<|0.0001|||||||Chi-squared|||||||< 0.0001
71911907|NCT01150760|143344327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71911908|NCT01150760|143344328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0012|||||||Chi-squared|||||||0.0012
71911909|NCT01150760|143344329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.003|||||||Chi-squared|||||||0.0030
71911910|NCT01150760|143344330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.7637|||||||Chi-squared|||||||0.7637
71911911|NCT01150760|143344331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.0402|||||||Chi-squared|||||||0.0402
71682841|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.79||||0.066|TWO_SIDED|95.0|-0.05|1.64|||repeated measures model||MNS, Week 9|||1.64|-0.05|0.066
71682842|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.73||||0.127|TWO_SIDED|95.0|-0.21|1.67|||repeated measures model||MNS, Week 13|||1.67|-0.21|0.127
71911912|NCT01150760|143344332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0755|||||||Chi-squared|||||||0.0755
71911913|NCT01150760|143344333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.0532|||||||Chi-squared|||||||0.0532
71911914|NCT01150760|143344334|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||< 0.0001
71911915|NCT01150760|143344335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71911916|NCT03238352|143344342|OTHER||Difference of Least Square mean|-1.22|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.657|-0.782|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Negative Control at Week 8 is a primary endpoint comparison.||-0.782|-1.657|<0.0001
71911917|NCT03238352|143344342|OTHER||Difference of Least Square mean|-1.28|STANDARD_ERROR_OF_MEAN|0.213|<|0.0001|TWO_SIDED|95.0|-1.705|-0.858|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.858|-1.705|<.0001
71911918|NCT03238352|143344342|OTHER||Difference of Least Square mean|-1.25|STANDARD_ERROR_OF_MEAN|0.176|<|0.0001|TWO_SIDED|95.0|-1.6|-0.901|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.||-0.901|-1.600|<0.0001
71911919|NCT03238352|143344343|OTHER||Diference of Least Square mean|37.46|STANDARD_ERROR_OF_MEAN|7.306|<|0.0004|TWO_SIDED|95.0|22.916|51.995||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||51.995|22.916|<0.0004
71911920|NCT03238352|143344343|OTHER||Diference of Least Square mean|49.88|STANDARD_ERROR_OF_MEAN|7.079|<|0.0001|TWO_SIDED|95.0|35.791|63.966||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|||63.966|35.791|<.0001
71911921|NCT03238352|143344343|OTHER||Diference of Least Square mean|43.67|STANDARD_ERROR_OF_MEAN|5.862|<|0.0001|TWO_SIDED|95.0|32.001|55.334||P-value from Van Elteren test.|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model||55.334|32.001|<.0001
71911922|NCT00108953|143344381|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.6||||0.016||95.0|0.33|0.95|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.||0.95|0.33|0.016
71911923|NCT00108953|143344382|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52||||0.007||95.0|0.37|0.74|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.74|0.37|0.007
71911924|NCT00108953|143344383|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.018||95.0|0.45|0.83|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||0.83|0.45|0.018
71682843|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.38||||0.481|TWO_SIDED|95.0|-0.69|1.46|||repeated measures model||MNS, Week 17|||1.46|-0.69|0.481
71867552|NCT01056718|143252271|SUPERIORITY_OR_OTHER||||||=|0.458|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.458
71682844|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65||||0.308|TWO_SIDED|95.0|-0.61|1.9|||repeated measures model||MNS, Week 21|||1.90|-0.61|0.308
71867553|NCT01056718|143252272|SUPERIORITY_OR_OTHER||||||=|0.561|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.561
71867554|NCT01056718|143252273|SUPERIORITY_OR_OTHER||||||=|0.734|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.734
71867555|NCT01056718|143252274|SUPERIORITY_OR_OTHER||||||=|0.129|TWO_SIDED||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.||||=.129
71911925|NCT00108953|143344385|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.038||95.0|0.4|1.05|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups||1.05|0.40|0.038
71911926|NCT01125293|143344408|OTHER|||||||0.69|||||||Two stage design, exact method|||In a two-stage Simon design, a VGPR or better rate of at least 18% is considered promising versus a 5% or less rate. In stage 1, if 1 or fewer of 23 evaluable participants achieve VGPR, the regimen is considered non-promising else continue with 24 more patients enrolled. If \</=4 of 47 evaluable patients have VGPR or better, the regimen is considered non-promising. If \>/=5, then the regimen is considered promising for further study. With this design, there is 90% power and 1-sided 10% alpha.|The study did not continue to stage 2 given 1 VGPR or better response was observed in 23 evaluable participants in stage 1.|||0.69
71867556|NCT05086276|143252276|SUPERIORITY||Odds Ratio (OR)|1.4||||0.525|TWO_SIDED|95.0|0.51|3.73||P value for statistical significance is \<0.05|Chi-squared|||||3.73|0.51|0.525
71682845|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71||||0.233|TWO_SIDED|95.0|-0.46|1.88|||repeated measures model||MNS, Week 25|||1.88|-0.46|0.233
71682846|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28||||0.444|TWO_SIDED|95.0|-0.45|1.02|||repeated measures model||WNS, Week 2|||1.02|-0.45|0.444
71682847|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.31||||0.002|TWO_SIDED|95.0|0.5|2.12|||repeated measures model||WNS, Week 5|||2.12|0.50|0.002
71682848|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.68||||0.143|TWO_SIDED|95.0|-0.24|1.6|||repeated measures model||WNS, Week 9|||1.60|-0.24|0.143
71682849|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62||||0.24|TWO_SIDED|95.0|-0.42|1.65|||repeated measures model||WNS, Week 13|||1.65|-0.42|0.240
71682850|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-0.98|1.35|||repeated measures model||WNS, Week 17|||1.35|-0.98|0.750
71682851|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.64||||0.324|TWO_SIDED|95.0|-0.64|1.91|||repeated measures model||WNS, Week 21|||1.91|-0.64|0.324
71867557|NCT05086276|143252276|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.525|TWO_SIDED|95.0|-7.52|14.71||P value for statistical significance is \<0.05|Chi-squared|||||14.71|-7.52|0.525
71867558|NCT05086276|143252277|SUPERIORITY||Least squares mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.491||0.973|TWO_SIDED|95.0|-0.954|0.987||P value for statistical significance is \<0.05|Mixed Models Analysis|||||0.987|-0.954|0.973
71867559|NCT05086276|143252279|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.16|TWO_SIDED|95.0|-0.06|0.34||P value for statistical significance is \<0.05|ANCOVA|||||0.34|-0.06|0.160
71867560|NCT05086276|143252280|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.1||0.027|TWO_SIDED|95.0|0.03|0.41||P value for statistical significance is \<0.05|ANCOVA|||||0.41|0.03|0.027
71682852|NCT01362244|142883811|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44||||0.468|TWO_SIDED|95.0|-0.77|1.66|||repeated measures model||WNS, Week 25|||1.66|-0.77|0.468
71867561|NCT00777088|143252281|NON_INFERIORITY|The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up|||||<|0.001|||||||Bayesian|||||||<.001
71867562|NCT00777088|143252282|NON_INFERIORITY_OR_EQUIVALENCE|The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability \>0.975.|||||<|0.001|||||||Bayesian|||||||<0.001
71867563|NCT03592745|143252293|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|32.0||||0.002|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in bicep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.002
71867564|NCT03592745|143252293|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to DC immediately following 3 weeks of training was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|87.0||||0.445|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median absolute change in tricep peak sEMG amplitude from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.445
71867565|NCT03592745|143252293|EQUIVALENCE|Statistical analysis of the median absolute change in bicep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|95.0||||0.678|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in bicep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.678
71867566|NCT03592745|143252293|EQUIVALENCE|Statistical analysis of the median absolute change in tricep peak sEMG amplitude from baseline to week 16 (3 month follow-up after training) was measured in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median absolute change in bicep peak sEMG amplitude between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|98.0||||0.777|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare the median absolute change in tricep peak sEMG from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.777
71867567|NCT03592745|143252294|EQUIVALENCE|Statistical analysis of median change from baseline to DC immediately following 3 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|112.0||||1|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 3 weeks (discharge) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||1.000
71867568|NCT03592745|143252294|EQUIVALENCE|Statistical analysis of median change from baseline to week 16 (3 month follow-up) was assessed with the Upper Extremity Fugl Meyer score in the active vs. sham tVNS conditions. Null hypothesis is that there is no difference in median change in Upper Extremity Fugl Meyer score between the active and sham tVNS conditions. A significance level of 0.05 was used (two-tailed).|U value|110.5||||0.95|TWO_SIDED|||||The Mann-Whitney Wilcoxon test was performed to compare median change in Upper Extremity Fugl Meyer score from baseline to 16 weeks (follow-up) across two separate study conditions (active vs. sham tVNS).|Wilcoxon (Mann-Whitney)|||||||0.950
71867569|NCT03406078|143252308|SUPERIORITY||Cumulative Odds Ratio|1.28||||0.434|TWO_SIDED|95.0|0.69|2.35|||Proportional odds model|Response variable: categorised % reduction from baseline in final OCS dose. Covariates in the model: treatment, region and daily OCS dose at baseline.||||2.35|0.69|0.434
71867570|NCT00350103|143252353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.041|TWO_SIDED|95.0|-0.88|-0.02|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||-0.02|-0.88|=0.0410
71867571|NCT00350103|143252353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|||=|0.2902|TWO_SIDED|95.0|-0.65|0.2|||ANCOVA||Estimated value is the difference of Least Square Means.|Last Observation Carried Forward (LOCF) procedure was applied for missing daily diary entries between start of trial medication and Visit 8 or last intake of trial medication in the case of discontinuation during the Titration or Maintenance Phase.||0.20|-0.65|=0.2902
71867572|NCT04828837|143252412|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|Mean Difference (Final Values)|0.39|||<|0.05|TWO_SIDED|95.0||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|Wilcoxon (Mann-Whitney)|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
71911927|NCT02481596|143344415|SUPERIORITY|||||||0.045||||||Beta=.083. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.045
71682853|NCT01362244|142883812|SUPERIORITY_OR_OTHER_LEGACY||Mixed effects model|-13.2||||0.005|TWO_SIDED|95.0|-22.2|-4.22|||ANCOVA|||||-4.22|-22.2|0.005
71682854|NCT01362244|142883813|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||||0.07|-0.06|
71682855|NCT01362244|142883814|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.68|||||TWO_SIDED|95.0|-1.33|12.68||||||||12.68|-1.33|
71867573|NCT04828837|143252413|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
71867574|NCT04828837|143252414|SUPERIORITY|The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.|||||<|0.05||||||We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies \<5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.|The generalized estimating equation (GEE|||Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.||||<0.05
71867575|NCT04828837|143252415|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71867576|NCT03014479|143252428|SUPERIORITY||Differences of Least Square Means|2.418||||0.2305|TWO_SIDED|95.0|-1.546|6.382|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||6.382|-1.546|0.2305
71867577|NCT03014479|143252429|SUPERIORITY||Differences of Least Square Means|1.938||||0.4536|TWO_SIDED|95.0|-3.15|7.027|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||7.027|-3.150|0.4536
71867578|NCT03014479|143252430|SUPERIORITY||Differences of Least Square Means|4.16||||0.0896|TWO_SIDED|95.0|-0.649|8.968|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.968|-0.649|0.0896
71867579|NCT03014479|143252431|SUPERIORITY||Differences of Least Square Means|-0.563||||0.8506|TWO_SIDED|95.0|-6.448|5.323|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||5.323|-6.448|0.8506
71867580|NCT03014479|143252432|SUPERIORITY||Differences of Least Square Means|2.696||||0.3533|TWO_SIDED|95.0|-3.018|8.41|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||8.410|-3.018|0.3533
71867581|NCT03014479|143252434|SUPERIORITY||Differences of Least Square Means|0.613||||0.5451|TWO_SIDED|95.0|-1.38|2.605|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors|||2.605|-1.380|0.5451
71867582|NCT01781078|143252451|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.3|||<|0.0001|ONE_SIDED|95.0||3.9|||Farrington-Manning score test|||||3.9||<0.0001
71867583|NCT01781078|143252452|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.1||||0.0006|ONE_SIDED|95.0||5.0|||Farrington-Manning score test|||||5.0||0.0006
71867584|NCT01781078|143252452|NON_INFERIORITY|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|0.0||||0.0002|ONE_SIDED|95.0||4.7|||Farrington-Manning score test|||||4.7||0.0002
71867585|NCT01081132|143252455|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.026|||<|0.001|TWO_SIDED|95.0|-8.865|-3.187|||Mixed Models Repeated Measures Analysis|||||-3.187|-8.865|<0.001
71867586|NCT01081132|143252456|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Cochran-Mantel-Haenszel|||||||0.010
71867587|NCT01081132|143252457|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.115||||0.104|TWO_SIDED|95.0|-0.254|0.024|||Mixed Models Repeated Measures Analysis|||||0.024|-0.254|0.104
71867588|NCT01081132|143252458|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.057||||0.408|TWO_SIDED|95.0|-0.192|0.078|||Mixed Models Repeated Measures Analysis|||||0.078|-0.192|0.408
71867589|NCT01081132|143252459|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.083||||0.176|TWO_SIDED|95.0|-0.203|0.037|||Mixed Models Repeated Measures Analysis|||||0.037|-0.203|0.176
71867590|NCT01081132|143252460|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05||||0.253|TWO_SIDED|95.0|-0.136|-0.036|||Mixed Models Repeated Measures Analysis|||||-0.036|-0.136|0.253
71867591|NCT01081132|143252461|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.004||||0.912|TWO_SIDED|95.0|-0.061|0.068|||Mixed Models Repeated Measures Analysis|||||0.068|-0.061|0.912
71867592|NCT01081132|143252462|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.029||||0.606|TWO_SIDED|95.0|-0.139|0.081|||Mixed Models Repeated Measures Analysis|||||0.081|-0.139|0.606
71867593|NCT01081132|143252463|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102||||0.228|TWO_SIDED|95.0|-0.064|0.268|||Mixed Models Repeated Measures Analysis|||||0.268|-0.064|0.228
71867594|NCT01081132|143252464|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.047||||0.41|TWO_SIDED|95.0|-0.159|0.065|||Mixed Models Repeated Measures Analysis|||||0.065|-0.159|0.410
71867595|NCT01081132|143252465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.208||||0.082|TWO_SIDED|95.0|-0.443|0.026|||Mixed Models Repeated Measures Analysis|||||0.026|-0.443|0.082
71867596|NCT01081132|143252466|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71867597|NCT01081132|143252467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.134|TWO_SIDED|95.0|-5.3|0.7|||Mixed Models Repeated Measures Analysis|||Global Executive Composite||0.7|-5.3|0.134
71867598|NCT01081132|143252467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.579|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Repeated Measures Analysis|||Behavioral Regulation Index||2.3|-4.0|0.579
71867599|NCT01081132|143252467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.072|TWO_SIDED|95.0|-5.6|0.2|||Mixed Models Repeated Measures Analysis|||Metacognition Index||0.2|-5.6|0.072
71867600|NCT01081132|143252468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.465|TWO_SIDED|95.0|-1.8|0.8|||Mixed Models Repeated Measures Analysis|||||0.8|-1.8|0.465
71867601|NCT05038163|143252488|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.63|-0.39|||Regression, Linear|||||-0.39|-0.63|<0.001
71867602|NCT05038163|143252488|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear|||||-0.33|-0.57|<0.001
71867603|NCT05038163|143252488|SUPERIORITY||Treatment Effect|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.24|||Regression, Linear|||||-0.24|-0.44|<0.001
71867604|NCT05038163|143252489|SUPERIORITY||Treatment Effect|-0.33||||0.003|TWO_SIDED|95.0|-0.55|-0.11|||Regression, Linear|||||-0.11|-0.55|0.003
71867605|NCT05038163|143252489|SUPERIORITY||Treatment Effect|-0.61|||<|0.001|TWO_SIDED|95.0|-0.87|-0.35|||Regression, Linear|||||-0.35|-0.87|<0.001
71867606|NCT05038163|143252489|SUPERIORITY||Treatment Effect|-0.25|||<|0.001|TWO_SIDED|95.0|-0.48|-0.17|||Regression, Linear|||||-0.17|-0.48|<0.001
71867607|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.67|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.32|-0.67|<0.001
71867608|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.53|||<|0.001|TWO_SIDED|95.0|-0.7|-0.36|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.36|-0.70|<0.001
71867609|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.57|-0.25|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.25|-0.57|<0.001
71867610|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.32|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Male||-0.32|-0.65|<0.001
71867611|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.28|||<|0.001|TWO_SIDED|95.0|-0.42|-0.14|||Regression, Linear||Unit: $ per 12-pack|Gender subgroup: Female or other||-0.14|-0.42|<0.001
71867612|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.57|||<|0.001|TWO_SIDED|95.0|-0.57|-0.27|||Regression, Linear|||Gender subgroup: Male|Unit: $ per 12-pack|-0.27|-0.57|<0.001
71867613|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-2.23|||<|0.001|TWO_SIDED|95.0|-3.34|-1.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-1.12|-3.34|<0.001
71867614|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.69|||<|0.001|TWO_SIDED|95.0|-1.15|-0.23|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.23|-1.15|<0.001
71867615|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
71867616|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.45|||<|0.001|TWO_SIDED|95.0|-0.24|1.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||1.14|-0.24|<0.001
71867617|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.5|||<|0.001|TWO_SIDED|95.0|-0.63|-0.37|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.37|-0.63|<0.001
71867618|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.96|||<|0.001|TWO_SIDED|95.0|-1.67|-0.25|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.25|-1.67|<0.001
71867619|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-1.16|0.4|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.40|-1.16|<0.001
71867620|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-1.07|0.19|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||0.19|-1.07|<0.001
71867621|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.54|||<|0.001|TWO_SIDED|95.0|-0.91|-0.17|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.17|-0.91|<0.001
71867622|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.00|0.00|<0.001
71867623|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.16|||<|0.001|TWO_SIDED|95.0|-0.36|0.68|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.68|-0.36|<0.001
71867624|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: white||-0.31|-0.57|<0.001
71867625|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-1.18|||<|0.001|TWO_SIDED|95.0|-2.04|-0.32|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.32|-2.04|<0.001
71867626|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.38|||<|0.001|TWO_SIDED|95.0|-0.9|0.14|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.14|-0.90|<0.001
71867627|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.54|-0.04|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: American Indian or Alaska Native||-0.04|-1.54|<0.001
71867628|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.51|||<|0.001|TWO_SIDED|95.0|-0.9|-0.12|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Asian||-0.12|-0.90|<0.001
71867629|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.8|||<|0.001|TWO_SIDED|95.0|0.8|0.8|||Regression, Logistic||Unit: $ per 12-pack|Race subgroup: Native Hawaiian or Pacific Islander||0.80|0.80|<0.001
71867630|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.04|||<|0.001|TWO_SIDED|95.0|-0.79|0.71|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Black or African American||0.71|-0.79|<0.001
71867631|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.33|||<|0.001|TWO_SIDED|95.0|-0.44|-0.22|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: White||-0.22|-0.44|<0.001
71867632|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.41|||<|0.001|TWO_SIDED|95.0|-0.76|-0.06|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: More Than One Race||-0.06|-0.76|<0.001
71867633|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.27|||<|0.001|TWO_SIDED|95.0|-0.85|0.31|||Regression, Linear||Unit: $ per 12-pack|Race subgroup: Unknown or Not Reported||0.31|-0.85|<0.001
71867634|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.23|||<|0.001|TWO_SIDED|95.0|-0.45|0.91|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.91|-0.45|<0.001
71867635|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.52|||<|0.001|TWO_SIDED|95.0|-0.65|-0.39|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.39|-0.65|<0.001
71867636|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.93|||<|0.001|TWO_SIDED|95.0|-1.48|-0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.38|-1.48|<0.001
71867637|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.16|||<|0.001|TWO_SIDED|95.0|-0.7|0.38|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.38|-0.70|<0.001
71867638|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.45|||<|0.001|TWO_SIDED|95.0|-0.57|-0.33|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.33|-0.57|<0.001
71867639|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.79|||<|0.001|TWO_SIDED|95.0|-1.42|-0.16|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Other or Prefer Not to Say||-0.16|-1.42|<0.001
71867640|NCT05038163|143252490|SUPERIORITY||Treatment Effect|0.01||||0.98|TWO_SIDED|95.0|-0.4|0.41|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Hispanic||0.41|-0.40|0.980
71867641|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.36|||<|0.001|TWO_SIDED|95.0|-0.47|-0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity subgroup: Not Hispanic||-0.25|-0.47|<0.001
71867642|NCT05038163|143252490|SUPERIORITY||Treatment Effect|-0.39|||<|0.001|TWO_SIDED|95.0|-1.03|0.25|||Regression, Linear||Unit: $ per 12-pack|Ethnicity Subgroup: Other or Prefer Not to Say||0.25|-1.03|<0.001
71867643|NCT03762200|143252496|OTHER|Confidence Interval|percentage of sucesses|87.4|||||TWO_SIDED|95.0|79.4|93.1||||||||93.1|79.4|
71867644|NCT03762200|143252497|OTHER|Confidence Interval|Percentage of Successes|77.7|||||TWO_SIDED|95.0|68.4|85.3||||||||85.3|68.4|
71867645|NCT03762200|143252498|OTHER|Confidence Interval|Percentage of Successes|92.2|||||TWO_SIDED|95.0|85.3|96.6||||||||96.6|85.3|
71867646|NCT03973931|143252508|NON_INFERIORITY|Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations|||||<|0.05|||||||GEE|To account for multiple treatment comparisons significance levels of 0.05/3||||||<0.05
71867647|NCT03973931|143252509|NON_INFERIORITY|Analysis of the longitudinal data (12 observations per patient) and estimated absolute differences in PDC between treatment group and usual care was analyzed using Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure was used.|||||<|0.05||||||To account for multiple treatment comparisons significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, R=number of significant stage 1 tests.|GEE|||||||<0.05
71911928|NCT02481596|143344415|SUPERIORITY|||||||0.006||||||Beta=.126. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.006
71911929|NCT02481596|143344416|SUPERIORITY|||||||0.518||||||Beta=.031. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.518
71911930|NCT02481596|143344416|SUPERIORITY|||||||0.092||||||Beta=.092. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.092
71911931|NCT02481596|143344417|SUPERIORITY|||||||0.53||||||Beta=-.027. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations||||.53
71867648|NCT00925353|143252516|SUPERIORITY_OR_OTHER||Actual lab results shown|1.0|||<|0.05||95.0|||||non-compartmental pharmacokinetic|The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.||Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.||||<0.05
71867649|NCT01302067|143252526|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.16|-0.66||Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.|ANCOVA|Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.|Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.||-0.66|-1.16|<0.0001
71867650|NCT01302067|143252526|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.11||0.0109|TWO_SIDED|95.0|-0.48|-0.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.06|-0.48|0.0109
71867651|NCT01302067|143252526|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.89|-0.39||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.||-0.39|-0.89|<0.0001
71867652|NCT01302067|143252527|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.48|-0.79||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.79|-1.48|<0.0001
71867653|NCT01302067|143252527|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.14||0.0082|TWO_SIDED|95.0|-0.67|-0.1||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.10|-0.67|0.0082
71867654|NCT01302067|143252527|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.41||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.41|-1.10|<0.0001
71867655|NCT01302067|143252528|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.76|-1.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.03|-1.76|<0.0001
71867656|NCT01302067|143252528|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.15||0.0006|TWO_SIDED|95.0|-0.83|-0.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.23|-0.83|0.0006
71867657|NCT01302067|143252528|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.23|-0.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.51|-1.23|<0.0001
71867658|NCT01302067|143252529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867659|NCT01302067|143252529|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0040
71867660|NCT01302067|143252529|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71911932|NCT02481596|143344417|SUPERIORITY|||||||0.41||||||Beta=-.037. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.41
71911933|NCT02481596|143344418|SUPERIORITY|||||||0.024||||||Beta=.088. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.024
71911934|NCT02481596|143344418|SUPERIORITY|||||||0.003||||||Beta=.128. Threshold p\<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.003
71911935|NCT02481596|143344419|SUPERIORITY|||||||0.001||||||Beta=-.133. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.||||.001
71911936|NCT02481596|143344419|SUPERIORITY|||||||0.012||||||Beta=-.115. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.||||.012
71911937|NCT02481596|143344420|SUPERIORITY|||||||0.015||||||Beta=.114. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.||||.015
71911938|NCT02481596|143344420|SUPERIORITY|||||||0.034||||||Beta=.101. Threshold p\<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.||||.034
71911939|NCT03205982|143344436|EQUIVALENCE|If the difference (between treatment and control arm) is greater than the minimal clinically important difference (MCID), we consider the treatment arm is different from the control arm. MCID is calculated as 0.25-0.5\* standard deviation (SD). Conversely, the equivalence margin is the biggest difference (between 2 arms) to be considered no difference between 2 arms. Therefore, the equivalence margin should be smaller than MCID, i.e., it should be smaller than the smallest possible MCID.|Odds Ratio (OR)|0.9943|STANDARD_ERROR_OF_MEAN|0.0005|<|0.0001|TWO_SIDED|95.0|0.993|0.995|||Mixed Models Analysis|generalized linear mixed model with logit link (logistic model)||Compares difference in adherence changes between Intervention and Control arms||0.995|0.993|<0.0001
71911940|NCT00631540|143344459|SUPERIORITY_OR_OTHER||Mean Patency Rate|91.7|||<|0.0001|TWO_SIDED|95.0|84.2|95.9|||Z-test, 1-sided||GEE model estimate.|Alternative hypothesis is 9-month primary patency rate greater than 60%.||95.9|84.2|<0.0001
71911941|NCT03136367|143344522|SUPERIORITY|||||||0.045||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.045
71911942|NCT03136367|143344522|SUPERIORITY|||||||0.2||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.20
71911943|NCT03136367|143344522|SUPERIORITY|||||||0.82||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.82
71911944|NCT03136367|143344523|SUPERIORITY|||||||0.048||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.048
71682856|NCT05153148|142883827|SUPERIORITY||Risk Difference (RD)|5.9|||=|0.446|TWO_SIDED|95.0|-9.3|21.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel (MH) risk difference was summarized along with the 2-sided 95% confidence interval (CI) using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional disease-modifying antirheumatic drugs (DMARDs) and region.|21.1|-9.3|=0.446
71911945|NCT03136367|143344523|SUPERIORITY|||||||0.015||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.015
71911946|NCT03136367|143344523|SUPERIORITY|||||||0.43||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.43
71911947|NCT03136367|143344524|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.46
71911948|NCT03136367|143344524|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.34
71911949|NCT03136367|143344524|SUPERIORITY|||||||0.165|||||||Mixed Models Analysis|Mixed effects linear regression that accounted clustering and was adjusted for surgeon and patient characteristics.||||||0.165
71911950|NCT03136367|143344526|SUPERIORITY|||||||0.25||||||Adjusted for repeated within-patient measurements|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.25
71911951|NCT03136367|143344526|SUPERIORITY|||||||0.89||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.89
71911952|NCT03136367|143344526|SUPERIORITY|||||||0.54||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.54
71911953|NCT03136367|143344527|SUPERIORITY|||||||0.72||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.72
71911954|NCT03136367|143344527|SUPERIORITY|||||||0.41||||||Adjusted for repeated within-patient measurements.|McNemar|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.41
71911955|NCT03136367|143344527|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
71911956|NCT03136367|143344528|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.01
71911957|NCT03136367|143344528|SUPERIORITY|||||||0.12|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.12
71911958|NCT03136367|143344528|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.78
71682857|NCT05153148|142883827|SUPERIORITY||Risk Difference (RD)|24.1|||=|0.002|TWO_SIDED|95.0|8.6|39.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.6|8.6|=0.002
71867661|NCT01302067|143252530|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71682858|NCT05153148|142883827|SUPERIORITY||Risk Difference (RD)|24.5|||=|0.002|TWO_SIDED|95.0|9.0|39.9|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR20 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|39.9|9.0|=0.002
71867662|NCT01302067|143252530|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867663|NCT01302067|143252530|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867664|NCT01302067|143252531|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.02|-0.5||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.50|-1.02|<0.0001
71867665|NCT01302067|143252531|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0662|TWO_SIDED|95.0|-0.41|0.01||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||0.01|-0.41|0.0662
71867666|NCT01302067|143252531|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.82|-0.3||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||-0.30|-0.82|<0.0001
71867667|NCT01302067|143252532|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867668|NCT01302067|143252532|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867669|NCT01302067|143252533|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867670|NCT01302067|143252533|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0006
71867671|NCT01302067|143252533|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0001
71867672|NCT01302067|143252534|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-2.04|-1.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.06|-2.04|<0.0001
71867673|NCT01302067|143252534|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.21||0.0121|TWO_SIDED|95.0|-0.92|-0.11||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.11|-0.92|0.0121
71867674|NCT01302067|143252534|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.25|<|0.0001|TWO_SIDED|95.0|-1.52|-0.55||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.55|-1.52|<0.0001
71867675|NCT01302067|143252535|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.55|-1.49||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-1.49|-2.55|<0.0001
71911959|NCT03136367|143344529|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
71911960|NCT03136367|143344529|SUPERIORITY||||||<|0.01|||||||Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||<0.01
71911961|NCT03136367|143344530|SUPERIORITY|||||||0.06||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.06
71911962|NCT03136367|143344530|SUPERIORITY|||||||0.65||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.65
71911963|NCT03136367|143344530|SUPERIORITY|||||||0.36||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.36
71911964|NCT03136367|143344531|SUPERIORITY|||||||0.11||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.11
71911965|NCT03136367|143344531|SUPERIORITY|||||||0.037||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.037
71911966|NCT03136367|143344531|SUPERIORITY|||||||0.28||||||Adjusted for repeated within-patient measurements.|Mixed Models Analysis|Mixed effects linear regression that accounted for clinician and site clustering and was adjusted for surgeon and patient characteristics.||||||0.28
71911967|NCT00676208|143344537|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
71911968|NCT00676208|143344538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.04
71911969|NCT02088541|143344571|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4221|TWO_SIDED|95.0|0.79|1.75|||Log Rank|||||1.75|0.79|0.4221
71911970|NCT02088541|143344572|SUPERIORITY|||||||0.9464|||||||Log Rank|||||||0.9464
71911971|NCT02088541|143344573|SUPERIORITY|||||||0.0986|||||||Cochran-Mantel-Haenszel|||||||0.0986
71911972|NCT02088541|143344575|SUPERIORITY|||||||0.0844|||||||Cochran-Mantel-Haenszel|||||||0.0844
71911973|NCT03170258|143344606|OTHER|||||||0.0015|||||||t-test, 2 sided|One-sample 2-sided t-test against a mean of 0 used to evaluate the main effect of VTA activation during neurofeedback.||||||0.0015
71911974|NCT03170258|143344607|OTHER||||||>|0.1|||||||t-test, 1 sided|One-sample t-test against 0 for the ratio of Beta to Theta power.||||||>0.10
71911975|NCT01391468|143344645|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71911976|NCT01391468|143344646|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.744
71911977|NCT01391468|143344647|SUPERIORITY_OR_OTHER|||||||0.0042|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0042
71911978|NCT01391468|143344648|SUPERIORITY_OR_OTHER|||||||0.0099|TWO_SIDED|||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)|||||||0.0099
71911979|NCT00511108|143344673|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-29.7||||0.002||95.0|-48.7|-10.6|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-10.6|-48.7|0.002
71911980|NCT00511108|143344674|SUPERIORITY_OR_OTHER||Geometric Mean Difference|73.8|||<|0.001||95.0|44.2|104.4|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and log-scaled baseline value as a covariate|The outcome was analyzed by ANCOVA on the log scale. Results have been back-transformed to the original scale.|||104.4|44.2|<0.001
71911981|NCT00511108|143344675|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-407.8|||<|0.001||95.0|-513.4|-302.1|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate||||-302.1|-513.4|<0.001
71911982|NCT00968708|143344725|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.962||||0.315|ONE_SIDED|97.5||1.16|||Cox proportional hazards|||Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.||1.160||0.315
71911983|NCT00968708|143344725|NON_INFERIORITY_OR_EQUIVALENCE|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was \<1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was \<1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.965||||0.332|ONE_SIDED|97.5||1.169||Stratified by endpoint renal function (defined as the last observed postbaseline renal function (normal renal function/mild renal impairment vs moderate/severe renal impairment including end-stage renal disease)) and geographic region.|Cox proportional hazards|||Stratified by endpoint renal function and geographic region||1.169||0.332
71867676|NCT01302067|143252535|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.22||0.0005|TWO_SIDED|95.0|-1.22|-0.34||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.34|-1.22|0.0005
71867677|NCT01302067|143252535|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-1.77|-0.71||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.||-0.71|-1.77|<0.0001
71867678|NCT01302067|143252536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71911984|NCT00968708|143344726|NON_INFERIORITY_OR_EQUIVALENCE|If the upper bound of the confidence interval for the primary MACE composite was \<1.0, then statistical superiority of alogliptin to placebo for the secondary MACE composite would be demonstrated.|Hazard Ratio (HR)|0.952|||||ONE_SIDED|97.5||1.135||||||||1.135||
71911985|NCT01975675|143344745|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
71911986|NCT01975675|143344745|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test|||||||< 0.001
71911987|NCT01975675|143344746|SUPERIORITY_OR_OTHER||Difference in proportions|-3.6|||||TWO_SIDED|95.0|-10.2|1.0|||||The 95% confidence interval (CI) on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||1.0|-10.2|
71911988|NCT01975675|143344746|SUPERIORITY_OR_OTHER||Difference in proportions|0.0|||||TWO_SIDED|95.0|-4.2|4.2|||||The 95% CI on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).|||4.2|-4.2|
71911989|NCT00871572|143344772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0296|TWO_SIDED|90.0|-1.64|-0.23|||Mixed Models Analysis|||||-0.23|-1.64|0.0296
71911990|NCT00871572|143344772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0418|TWO_SIDED|90.0|-1.37|-0.15|||Mixed Models Analysis|||||-0.15|-1.37|0.0418
71911991|NCT00871572|143344772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0514|TWO_SIDED|90.0|-1.41|-0.12|||Mixed Models Analysis|||||-0.12|-1.41|0.0514
71867679|NCT01302067|143252536|SUPERIORITY_OR_OTHER|||||||0.0348|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0348
71867680|NCT01302067|143252536|SUPERIORITY_OR_OTHER|||||||0.0003|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0003
71911992|NCT00871572|143344773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.62||||0.2565|TWO_SIDED|95.0|-4.46|1.21|||Mixed Models Analysis|||||1.21|-4.46|0.2565
71911993|NCT00871572|143344773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.1245|TWO_SIDED|95.0|-4.25|0.53|||Mixed Models Analysis|||||0.53|-4.25|0.1245
71911994|NCT00871572|143344773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.41||||0.0594|TWO_SIDED|95.0|-4.92|0.1|||Mixed Models Analysis|||||0.10|-4.92|0.0594
71911995|NCT00871572|143344774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-124.56||||0.4978|TWO_SIDED|95.0|-490.02|240.9|||ANCOVA|||||240.90|-490.02|0.4978
71911996|NCT00871572|143344774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-338.64||||0.0372|TWO_SIDED|95.0|-656.55|-20.72|||ANCOVA|||||-20.72|-656.55|0.0372
71911997|NCT00871572|143344774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-466.83||||0.0068|TWO_SIDED|95.0|-799.48|-134.18|||ANCOVA|||||-134.18|-799.48|0.0068
71911998|NCT00871572|143344775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.814|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.814
71911999|NCT00871572|143344775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.681|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||||0.7|-0.4|0.681
71912000|NCT00871572|143344775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.715|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||||0.5|-0.7|0.715
71912001|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.56||||0.0248|TWO_SIDED|95.0|-44.03|-3.09||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-3.09|-44.03|0.0248
71912002|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.28||||0.0002|TWO_SIDED|95.0|-53.08|-17.48||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-17.48|-53.08|0.0002
71912003|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.32|||<|0.0001|TWO_SIDED|95.0|-58.12|-20.53||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis|||||-20.53|-58.12|<0.0001
71912004|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42||||0.6513|TWO_SIDED|95.0|-34.66|21.82||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||21.82|-34.66|0.6513
71912005|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.2||||0.5045|TWO_SIDED|95.0|-32.61|16.21||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||16.21|-32.61|0.5045
71912006|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2||||0.5774|TWO_SIDED|95.0|-32.9|18.49||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis|||||18.49|-32.90|0.5774
71912007|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.81||||0.0045|TWO_SIDED|95.0|-60.1|-11.53||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-11.53|-60.10|0.0045
71912008|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.15||||0.0024|TWO_SIDED|95.0|-54.1|-12.21||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-12.21|-54.10|0.0024
71912009|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.87||||0.0011|TWO_SIDED|95.0|-59.98|-15.75||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis|||||-15.75|-59.98|0.0011
71912010|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.48||||0.0389|TWO_SIDED|95.0|-55.47|-1.49||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||-1.49|-55.47|0.0389
71912011|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65||||0.1896|TWO_SIDED|95.0|-39.24|7.94||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||7.94|-39.24|0.1896
71912012|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.56||||0.0729|TWO_SIDED|95.0|-47.28|2.16||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis|||||2.16|-47.28|0.0729
71912013|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.78||||0.0041|TWO_SIDED|95.0|-74.79|-14.77||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-14.77|-74.79|0.0041
71912014|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.45|||<|0.0001|TWO_SIDED|95.0|-80.42|-28.48||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-28.48|-80.42|<0.0001
71912015|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.19||||0.0013|TWO_SIDED|95.0|-73.57|-18.81||P-value is for Pre Evening Meal.|Mixed Models Analysis|||||-18.81|-73.57|0.0013
71682859|NCT05153148|142883828|SUPERIORITY||Risk Difference (RD)|5.7|||=|0.312|TWO_SIDED|95.0|-5.3|16.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|16.6|-5.3|=0.312
71912016|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.82||||0.0118|TWO_SIDED|95.0|-70.51|-9.13||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-9.13|-70.51|0.0118
71912017|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.8||||0.0016|TWO_SIDED|95.0|-70.42|-17.18||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-17.18|-70.42|0.0016
71912018|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.56||||0.0065|TWO_SIDED|95.0|-67.63|-11.48||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis|||||-11.48|-67.63|0.0065
71912019|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.88||||0.0154|TWO_SIDED|95.0|-66.43|-7.33||P-value is for Bedtime.|Mixed Models Analysis|||||-7.33|-66.43|0.0154
71912020|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.5||||0.0006|TWO_SIDED|95.0|-71.93|-21.07||P-value is for Bedtime.|Mixed Models Analysis|||||-21.07|-71.93|0.0006
71912021|NCT00871572|143344778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.07||||0.0029|TWO_SIDED|95.0|-69.13|-15.01||P-value is for Bedtime.|Mixed Models Analysis|||||-15.01|-69.13|0.0029
71912022|NCT00871572|143344779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.62||||0.3815|TWO_SIDED|95.0|-32.44|83.68|||Mixed Models Analysis|||||83.68|-32.44|0.3815
71912023|NCT00871572|143344779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.4||||0.8315|TWO_SIDED|95.0|-45.12|55.93|||Mixed Models Analysis|||||55.93|-45.12|0.8315
71912024|NCT00871572|143344779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.25||||0.3658|TWO_SIDED|95.0|-28.93|77.44|||Mixed Models Analysis|||||77.44|-28.93|0.3658
71912025|NCT00871572|143344780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|55.06||||0.2131|TWO_SIDED|95.0|-32.24|142.37|||Mixed Models Analysis|||||142.37|-32.24|0.2131
71912026|NCT00871572|143344780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|89.68||||0.022|TWO_SIDED|95.0|13.27|166.1|||Mixed Models Analysis|||||166.10|13.27|0.0220
71912027|NCT00871572|143344780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|107.26||||0.0101|TWO_SIDED|95.0|26.29|188.22|||Mixed Models Analysis|||||188.22|26.29|0.0101
71912028|NCT00871572|143344781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.87||||0.1596|TWO_SIDED|95.0|-0.75|4.49|||Mixed Models Analysis|||||4.49|-0.75|0.1596
71912029|NCT00871572|143344781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.03||||0.0791|TWO_SIDED|95.0|-0.24|4.31|||Mixed Models Analysis|||||4.31|-0.24|0.0791
71912030|NCT00871572|143344781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.1564|TWO_SIDED|95.0|-0.67|4.1|||Mixed Models Analysis|||||4.10|-0.67|0.1564
71912031|NCT00871572|143344782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8018.51||||0.45|TWO_SIDED|95.0|-13104.14|29141.16|||ANCOVA|||||29141.16|-13104.14|0.4500
71912032|NCT00871572|143344782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5174.85||||0.5739|TWO_SIDED|95.0|-13158.65|23508.35|||ANCOVA|||||23508.35|-13158.65|0.5739
71912033|NCT00871572|143344782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18153.92||||0.0653|TWO_SIDED|95.0|-1188.23|37496.06|||ANCOVA|||||37496.06|-1188.23|0.0653
71912034|NCT00871572|143344783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18094.32||||0.6209|TWO_SIDED|95.0|-54734.08|90922.71|||ANCOVA|||||90922.71|-54734.08|0.6209
71912035|NCT00871572|143344783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5783.59||||0.8581|TWO_SIDED|95.0|-58650.71|70217.89|||ANCOVA|||||70217.89|-58650.71|0.8581
71912036|NCT00871572|143344783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36218.98||||0.285|TWO_SIDED|95.0|-30955.5|103393.46|||ANCOVA|||||103393.46|-30955.50|0.2850
71912037|NCT00871572|143344784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.584|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.584
71912038|NCT00871572|143344784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.426|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.426
71912039|NCT00871572|143344784|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.657|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||||0.4|-0.6|0.657
71912040|NCT00871572|143344785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.365|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.365
71912041|NCT00871572|143344785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.191|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.191
71912042|NCT00871572|143344785|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.297|TWO_SIDED|95.0|-0.1|0.4|||ANCOVA|||||0.4|-0.1|0.297
71912043|NCT00871572|143344786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.523|TWO_SIDED|95.0|-0.8|0.4|||ANCOVA|||||0.4|-0.8|0.523
71867681|NCT01302067|143252537|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867682|NCT01302067|143252537|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||0.0002
71867683|NCT01302067|143252537|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.||||<0.0001
71867684|NCT01302067|143252538|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||<0.0001
71867685|NCT01302067|143252538|SUPERIORITY_OR_OTHER|||||||0.0057|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0057
71867686|NCT01302067|143252538|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0008
71867687|NCT01302067|143252539|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0007
71867688|NCT01302067|143252539|SUPERIORITY_OR_OTHER|||||||0.0091|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.0091
71867689|NCT01302067|143252539|SUPERIORITY_OR_OTHER|||||||0.3901|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.||||0.3901
71867690|NCT01302067|143252540|SUPERIORITY_OR_OTHER||Least squares mean difference|-12.47|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-15.49|-9.45||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-9.45|-15.49|<0.0001
71867691|NCT01302067|143252540|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.69|STANDARD_ERROR_OF_MEAN|1.26||0.0002|TWO_SIDED|95.0|-7.15|-2.22||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-2.22|-7.15|0.0002
71867692|NCT01302067|143252540|SUPERIORITY_OR_OTHER||Least squares mean difference|-7.78|STANDARD_ERROR_OF_MEAN|1.53|<|0.0001|TWO_SIDED|95.0|-10.78|-4.78||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.||-4.78|-10.78|<0.0001
71867693|NCT01302067|143252541|SUPERIORITY_OR_OTHER||Least squares mean difference|10.46|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|7.2|13.73||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||13.73|7.20|<0.0001
71912044|NCT00871572|143344786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.476|TWO_SIDED|95.0|-0.7|0.3|||ANCOVA|||||0.3|-0.7|0.476
71912045|NCT00871572|143344786|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.634|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||||0.4|-0.7|0.634
71912046|NCT00871572|143344787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.6|0.6|||ANCOVA|||||0.6|-0.6|0.919
71912047|NCT00871572|143344787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.864|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.864
71912048|NCT00871572|143344787|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.726|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|||||0.7|-0.5|0.726
71912049|NCT00735670|143344788|SUPERIORITY_OR_OTHER|||||||0.445|||||||Fisher Exact|||||||0.445
71912050|NCT00735670|143344789|SUPERIORITY_OR_OTHER||REML|-0.31||||0.725|TWO_SIDED|95.0|-0.48|-0.15||Comparison of venlafaxine vs. placebo on change of PHQ-9 over time controlling for baseline PHQ-9 score.|Mixed Models Analysis|||A linear mixed model (LMM) analysis was used and included a random intercept effect based on lowest Akaike's Information Criterion values when we compared three random coefficient models (intercept, slope and intercept and slope). To examine whether allocation group influenced the effect of time and baseline PHQ-9 sore on the trajectory of PHQ-9 scores, we included two interaction terms (time by allocation group and baseline PHQ-9 score by allocation group).||-0.15|-0.48|0.725
71912051|NCT03920865|143344825|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.802|||||TWO_SIDED|90.0|0.627|1.03||||||||1.03|0.627|
71912052|NCT03920865|143344825|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.842|||||TWO_SIDED|90.0|0.588|1.21||||||||1.21|0.588|
71867694|NCT01302067|143252541|SUPERIORITY_OR_OTHER||Least squares mean difference|4.68|STANDARD_ERROR_OF_MEAN|1.36||0.0006|TWO_SIDED|95.0|2.01|7.36||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.36|2.01|0.0006
71867695|NCT01302067|143252541|SUPERIORITY_OR_OTHER||Least squares mean difference|5.78|STANDARD_ERROR_OF_MEAN|1.66||0.0005|TWO_SIDED|95.0|2.53|9.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.03|2.53|0.0005
71867696|NCT01302067|143252542|SUPERIORITY_OR_OTHER||Least squares mean difference|10.91|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|7.73|14.09||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||14.09|7.73|<0.0001
71867697|NCT01302067|143252542|SUPERIORITY_OR_OTHER||Least squares mean difference|4.36|STANDARD_ERROR_OF_MEAN|1.33||0.001|TWO_SIDED|95.0|1.76|6.96||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.96|1.76|0.0010
71867698|NCT01302067|143252542|SUPERIORITY_OR_OTHER||Least squares mean difference|6.55|STANDARD_ERROR_OF_MEAN|1.61|<|0.0001|TWO_SIDED|95.0|3.39|9.72||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.72|3.39|<0.0001
71867699|NCT01302067|143252543|SUPERIORITY_OR_OTHER||Least squares mean difference|7.46|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|4.4|10.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||10.51|4.40|<0.0001
71867700|NCT01302067|143252543|SUPERIORITY_OR_OTHER||Least squares mean difference|3.74|STANDARD_ERROR_OF_MEAN|1.27||0.0034|TWO_SIDED|95.0|1.24|6.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.23|1.24|0.0034
71867701|NCT01302067|143252543|SUPERIORITY_OR_OTHER||Least squares mean difference|3.72|STANDARD_ERROR_OF_MEAN|1.55||0.0164|TWO_SIDED|95.0|0.68|6.76||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.76|0.68|0.0164
71867702|NCT01302067|143252544|SUPERIORITY_OR_OTHER||Least squares mean difference|7.5|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|5.03|9.97||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||9.97|5.03|<0.0001
71867703|NCT01302067|143252544|SUPERIORITY_OR_OTHER||Least squares mean difference|3.68|STANDARD_ERROR_OF_MEAN|1.03||0.0004|TWO_SIDED|95.0|1.65|5.7||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||5.70|1.65|0.0004
71867704|NCT01302067|143252544|SUPERIORITY_OR_OTHER||Least squares mean difference|3.82|STANDARD_ERROR_OF_MEAN|1.25||0.0023|TWO_SIDED|95.0|1.36|6.28||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.28|1.36|0.0023
71867705|NCT01302067|143252545|SUPERIORITY_OR_OTHER||Least squares mean difference|9.37|STANDARD_ERROR_OF_MEAN|1.43|<|0.0001|TWO_SIDED|95.0|6.56|12.18||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||12.18|6.56|<0.0001
71867706|NCT01302067|143252545|SUPERIORITY_OR_OTHER||Least squares mean difference|4.23|STANDARD_ERROR_OF_MEAN|1.17||0.0003|TWO_SIDED|95.0|1.93|6.53||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||6.53|1.93|0.0003
71912053|NCT03920865|143344827|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.95|||||TWO_SIDED|90.0|0.695|1.3||||||||1.30|0.695|
71912054|NCT03920865|143344827|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.953|||||TWO_SIDED|90.0|0.715|1.27||||||||1.27|0.715|
71912055|NCT03920865|143344828|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|0.83|1.39||||||||1.39|0.830|
71912056|NCT03920865|143344828|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.947|||||TWO_SIDED|90.0|0.74|1.21||||||||1.21|0.740|
71912057|NCT03920865|143344830|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|1.2|||||TWO_SIDED|90.0|0.962|1.49||||||||1.49|0.962|
71912058|NCT03920865|143344830|OTHER|Descriptive statistics.|Ratio of Geometric Least Squares Means|0.991|||||TWO_SIDED|90.0|0.81|1.21||||||||1.21|0.810|
71912059|NCT00753688|143344851|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.26|0.48||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.48|0.26|<0.001
71912060|NCT00753688|143344852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.256|TWO_SIDED|95.0|0.67|1.12||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||1.12|0.67|0.256
71912061|NCT00753688|143344856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.23|0.6||Stratified two-sided log rank p-value for leiomyosarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.23|<0.001
71912062|NCT00753688|143344856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.43||||0.005|TWO_SIDED|95.0|0.19|0.98||Stratified two-sided log rank p-value for synovial sarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.98|0.19|0.005
71912063|NCT00753688|143344856|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.001|TWO_SIDED|95.0|0.25|0.6||Stratified two-sided log rank p-value for other STS histologies|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).|||0.60|0.25|<0.001
71912064|NCT01854593|143344862|SUPERIORITY_OR_OTHER|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||||||0.025
71912065|NCT01854593|143344863|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||||||0.006
71912066|NCT01854593|143344864|SUPERIORITY_OR_OTHER|||||||0.033|||||||Fisher Exact|||||||0.033
71912067|NCT01854593|143344865|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71912068|NCT01854593|143344866|SUPERIORITY_OR_OTHER|||||||0.667|||||||Wilcoxon (Mann-Whitney)|||||||0.667
71912069|NCT01854593|143344867|SUPERIORITY_OR_OTHER|||||||0.593|||||||Fisher Exact|||||||0.593
71912070|NCT01854593|143344868|SUPERIORITY_OR_OTHER|||||||0.298|||||||Wilcoxon (Mann-Whitney)|||||||0.298
71912071|NCT01854593|143344869|SUPERIORITY_OR_OTHER|||||||0.929|||||||Wilcoxon (Mann-Whitney)|||||||0.929
71912072|NCT01854593|143344870|SUPERIORITY_OR_OTHER|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||||||0.445
71682860|NCT05153148|142883828|SUPERIORITY||Risk Difference (RD)|17.0|||=|0.005|TWO_SIDED|95.0|5.0|29.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.1|5.0|=0.005
71912073|NCT01854593|143344871|SUPERIORITY_OR_OTHER|||||||0.131|||||||Chi-squared|||||||0.131
71912074|NCT01854593|143344872|SUPERIORITY_OR_OTHER|||||||0.149|||||||Fisher Exact|||||||0.149
71912075|NCT01854593|143344873|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|||||||0.670
71912076|NCT01854593|143344874|SUPERIORITY_OR_OTHER|||||||0.378|||||||Chi-squared|||||||0.378
71912077|NCT03803202|143344933|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.7|1.85|||t-test, 2 sided|||Serotype 1, Day 1||1.85|0.70|
71912078|NCT03803202|143344933|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.72|1.9|||t-test, 2 sided|||Serotype 1, Day 1||1.90|0.72|
71912079|NCT03803202|143344933|OTHER||Ratio of GMT|1.17|||||TWO_SIDED|95.0|0.74|1.87|||t-test, 2 sided|||Serotype 1, Day 1||1.87|0.74|
71912080|NCT03803202|143344933|OTHER||Ratio of GMT|1.57|||||TWO_SIDED|95.0|0.68|3.63|||t-test, 2 sided|||Serotype 3, Day 1||3.63|0.68|
71912081|NCT03803202|143344933|OTHER||Ratio of GMT|2.04|||||TWO_SIDED|95.0|0.86|4.82|||t-test, 2 sided|||Serotype 3, Day 1||4.82|0.86|
71912082|NCT03803202|143344933|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.31|1.46|||t-test, 2 sided|||Serotype 3, Day 1||1.46|0.31|
71912083|NCT03803202|143344933|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.27|4.55|||t-test, 2 sided|||Serotype 4, Day 1||4.55|0.27|
71912084|NCT03803202|143344933|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.19|2.61|||t-test, 2 sided|||Serotype 4, Day 1||2.61|0.19|
71912085|NCT03803202|143344933|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|0.49|6.85|||t-test, 2 sided|||Serotype 4, Day 1||6.85|0.49|
71912086|NCT03803202|143344933|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|0.76|4.73|||t-test, 2 sided|||Serotype 5, Day 1||4.73|0.76|
71912087|NCT03803202|143344933|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.62|2.4|||t-test, 2 sided|||Serotype 5, Day 1||2.40|0.62|
71912088|NCT03803202|143344933|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.52|1.65|||t-test, 2 sided|||Serotype 5, Day 1||1.65|0.52|
71912089|NCT03803202|143344933|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.25|2.82|||t-test, 2 sided|||Serotype 6A, Day 1||2.82|0.25|
71912090|NCT03803202|143344933|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.24|2.23|||t-test, 2 sided|||Serotype 6A, Day 1||2.23|0.24|
71912091|NCT03803202|143344933|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Serotype 6A, Day 1||3.41|0.31|
71912092|NCT03803202|143344933|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.32|4.46|||t-test, 2 sided|||Serotype 6B,Day 1||4.46|0.32|
71912093|NCT03803202|143344933|OTHER||Ratio of GMT|1.3|||||TWO_SIDED|95.0|0.42|4.05|||t-test, 2 sided|||Serotype 6B, Day 1||4.05|0.42|
71912094|NCT03803202|143344933|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.24|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.24|
71912095|NCT03803202|143344933|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.26|2.17|||t-test, 2 sided|||Serotype 7F, Day 1||2.17|0.26|
71912096|NCT03803202|143344933|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.11|0.89|||t-test, 2 sided|||Serotype 7F, Day 1||0.89|0.11|
71912097|NCT03803202|143344933|OTHER||Ratio of GMT|0.31|||||TWO_SIDED|95.0|0.1|0.93|||t-test, 2 sided|||Serotype 7F, Day 1||0.93|0.10|
71912098|NCT03803202|143344933|OTHER||Ratio of GMT|1.92|||||TWO_SIDED|95.0|0.74|4.99|||t-test, 2 sided|||Serotype 9V, Day 1||4.99|0.74|
71867707|NCT01302067|143252545|SUPERIORITY_OR_OTHER||Least squares mean difference|5.14|STANDARD_ERROR_OF_MEAN|1.43||0.0003|TWO_SIDED|95.0|2.34|7.94||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.||7.94|2.34|0.0003
71867708|NCT01302067|143252546|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0016
71867709|NCT01302067|143252546|SUPERIORITY_OR_OTHER|||||||0.8121|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.8121
71867710|NCT01302067|143252546|SUPERIORITY_OR_OTHER|||||||0.0015|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0015
71867711|NCT01302067|143252547|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||<0.0001
71867712|NCT01302067|143252547|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0006
71867713|NCT01302067|143252547|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED|||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.||||0.0027
71867714|NCT03507777|143252592|SUPERIORITY||||||<|0.0001|||||||Linear mixed model|||||||<0.0001
71867715|NCT03507777|143252593|SUPERIORITY|||||||0.2487|||||||A Cox regression model|||||||0.2487
71867716|NCT03507777|143252594|SUPERIORITY|||||||0.2952|||||||A Cox regression model|||||||0.2952
71867717|NCT00006011|143252617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||"Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.~Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1."||1.17|0.69|
71867718|NCT02015455|143252633|SUPERIORITY||Percent Difference in Median|-0.7||||0.54|TWO_SIDED|95.0|-2.9|1.5|||Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, and site time trends. Random effects for clinic and provider.|Percent difference in median of the intervention group with respect to the control group.|||1.5|-2.9|0.54
71682861|NCT05153148|142883828|SUPERIORITY||Risk Difference (RD)|16.4|||=|0.009|TWO_SIDED|95.0|4.2|28.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of ACR50 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.6|4.2|=0.009
71867719|NCT02015455|143252634|SUPERIORITY||Odds Ratio (OR)|0.95||||0.04|TWO_SIDED|95.0|0.91|1.0||A p-value \<0.05 was considered significant.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.00|0.91|0.04
71867720|NCT02015455|143252635|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.9|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.90|0.02
71867721|NCT02015455|143252636|SUPERIORITY||Odds Ratio (OR)|0.95||||0.02|TWO_SIDED|95.0|0.91|0.99||The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, prior opioid use, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||0.99|0.91|0.02
71867722|NCT02015455|143252640|SUPERIORITY||Odds Ratio (OR)|0.99||||0.74|TWO_SIDED|95.0|0.91|1.07||Statistical significance defined as P\<0.05|Mixed Models Analysis|Adjusted for site, clinic size, age, sex, image modality, comorbidity, site time trends. Random effects for clinic and provider.|Odds ratio is for the intervention group with respect to the control group.|||1.07|0.91|0.74
71867723|NCT00774930|143252646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0165|TWO_SIDED||||||ANCOVA|This analysis does not include any imputation for the early roll over subjects||||||0.0165
71867724|NCT00774930|143252647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2544|||||||ANCOVA|ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening||||||0.2544
71867725|NCT01177800|143252744|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71867726|NCT01177800|143252745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 10: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
71867727|NCT01177800|143252746|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71867728|NCT01177800|143252747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 26: p-value was calculated by Non parametric ANOVA by van der Waerden method.||||<0.001
71867729|NCT03527550|143252749|SUPERIORITY|||||||0.95|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in negative urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in negative urgency as a function of condition (interaction of condition X time; reported below).||||0.95
71867730|NCT03527550|143252750|SUPERIORITY|||||||0.64|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in positive urgency at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in positive urgency as a function of condition (interaction of condition X time; reported below).||||0.64
71682862|NCT05153148|142883829|SUPERIORITY||Risk Difference (RD)|2.9|||=|0.532|TWO_SIDED|95.0|-6.6|12.7|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||12.7|-6.6|=0.532
71867731|NCT03527550|143252751|SUPERIORITY|||||||0.91||||||Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).|ANOVA|||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in stop-signal reaction time at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in stop-signal reaction time as a function of condition (interaction of condition X time; reported below).||||0.91
71867732|NCT03527550|143252755|SUPERIORITY|||||||0.24|||||||ANOVA|Repeated-measures ANOVA. P-value reflects the significance of the interaction term (condition x time).||A 2 (condition: TAU, TAU + cognitive training) x 2 (time) repeated-measures Analysis of Variance (ANOVA) was used to test change in distress intolerance at time 1 (admission) and time 2 (discharge), and whether participants differ in their average change in distress intolerance as a function of condition (interaction of condition X time; reported below).||||.24
71867733|NCT00911937|143252757|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.37|-0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.08|-0.37|0.0030
71867734|NCT00911937|143252758|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.0772|TWO_SIDED|95.0|-0.27|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.27|0.0772
71912099|NCT03803202|143344933|OTHER||Ratio of GMT|0.48|||||TWO_SIDED|95.0|0.15|1.61|||t-test, 2 sided|||Serotype 9V, Day 1||1.61|0.15|
71912100|NCT03803202|143344933|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.21|1.9|||t-test, 2 sided|||Serotype 9V, Day 1||1.90|0.21|
71912101|NCT03803202|143344933|OTHER||Ratio of GMT|4.2|||||TWO_SIDED|95.0|1.17|15.09|||t-test, 2 sided|||Serotype 14, Day 1||15.09|1.17|
71912102|NCT03803202|143344933|OTHER||Ratio of GMT|1.91|||||TWO_SIDED|95.0|0.52|7.07|||t-test, 2 sided|||Serotype 14, Day 1||7.07|0.52|
71912103|NCT03803202|143344933|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.23|4.25|||t-test, 2 sided|||Serotype 14, Day 1||4.25|0.23|
71912104|NCT03803202|143344933|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.21|2.62|||t-test, 2 sided|||Serotype 18C, Day 1||2.62|0.21|
71912105|NCT03803202|143344933|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.37|3.77|||t-test, 2 sided|||Serotype 18C, Day 1||3.77|0.37|
71912106|NCT03803202|143344933|OTHER||Ratio of GMT|1.22|||||TWO_SIDED|95.0|0.38|3.94|||t-test, 2 sided|||Serotype 18C, Day 1||3.94|0.38|
71912107|NCT03803202|143344933|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.51|2.45|||t-test, 2 sided|||Serotype 19A, Day 1||2.45|0.51|
71912108|NCT03803202|143344933|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.31|1.63|||t-test, 2 sided|||Serotype 19A, Day 1||1.63|0.31|
71912109|NCT03803202|143344933|OTHER||Ratio of GMT|0.74|||||TWO_SIDED|95.0|0.36|1.53|||t-test, 2 sided|||Serotype 19A, Day 1||1.53|0.36|
71912110|NCT03803202|143344933|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.24|2.08|||t-test, 2 sided|||Serotype 19F, Day 1||2.08|0.24|
71912111|NCT03803202|143344933|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.44|3.5|||t-test, 2 sided|||Serotype 19F, Day 1||3.50|0.44|
71912112|NCT03803202|143344933|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.58|3.61|||t-test, 2 sided|||Serotype 19F, Day 1||3.61|0.58|
71912113|NCT03803202|143344933|OTHER||Ratio of GMT|2.22|||||TWO_SIDED|95.0|0.46|10.69|||t-test, 2 sided|||Serotype 23F, Day 1||10.69|0.46|
71912114|NCT03803202|143344933|OTHER||Ratio of GMT|1.36|||||TWO_SIDED|95.0|0.31|5.99|||t-test, 2 sided|||Serotype 23F, Day 1||5.99|0.31|
71912115|NCT03803202|143344933|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.15|3.01|||t-test, 2 sided|||Serotype 23F, Day 1||3.01|0.15|
71912116|NCT03803202|143344933|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.5|1.74|||t-test, 2 sided|||Serotype 1, Day 30||1.74|0.50|
71912117|NCT03803202|143344933|OTHER||Ratio of GMT|0.72|||||TWO_SIDED|95.0|0.39|1.32|||t-test, 2 sided|||Serotype 1, Day 30||1.32|0.39|
71912118|NCT03803202|143344933|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.35|1.39|||t-test, 2 sided|||Serotype 1, Day 30||1.39|0.35|
71912119|NCT03803202|143344933|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.66|1.8|||t-test, 2 sided|||Serotype 3, Day 30||1.80|0.66|
71912120|NCT03803202|143344933|OTHER||Ratio of GMT|1.44|||||TWO_SIDED|95.0|0.9|2.29|||t-test, 2 sided|||Serotype 3, Day 30||2.29|0.90|
71912121|NCT03803202|143344933|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.76|2.17|||t-test, 2 sided|||Serotype 3, Day 30||2.17|0.76|
71912122|NCT03803202|143344933|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.5|1.35|||t-test, 2 sided|||Serotype 4, Day 30||1.35|0.50|
71912123|NCT03803202|143344933|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.24|1.02|||t-test, 2 sided|||Serotype 4, Day 30||1.02|0.24|
71912124|NCT03803202|143344933|OTHER||Ratio of GMT|1.06|||||TWO_SIDED|95.0|0.6|1.89|||t-test, 2 sided|||Serotype 4, Day 30||1.89|0.60|
71912125|NCT03803202|143344933|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.41|1.15|||t-test, 2 sided|||Serotype 5, Day 30||1.15|0.41|
71912126|NCT03803202|143344933|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.2|||t-test, 2 sided|||Serotype 5, Day 30||1.20|0.31|
71912127|NCT03803202|143344933|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.48|1.32|||t-test, 2 sided|||Serotype 5, Day 30||1.32|0.48|
71912128|NCT03803202|143344933|OTHER||Ratio of GMT|0.52|||||TWO_SIDED|95.0|0.28|0.98|||t-test, 2 sided|||Serotype 6A, Day 30||0.98|0.28|
71912129|NCT03803202|143344933|OTHER||Ratio of GMT|0.32|||||TWO_SIDED|95.0|0.15|0.68|||t-test, 2 sided|||Serotype 6A, Day 30||0.68|0.15|
71912130|NCT03803202|143344933|OTHER||Ratio of GMT|0.37|||||TWO_SIDED|95.0|0.21|0.66|||t-test, 2 sided|||Serotype 6A, Day 30||0.66|0.21|
71912131|NCT03803202|143344933|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.42|1.18|||t-test, 2 sided|||Serotype 6B, Day 30||1.18|0.42|
71912132|NCT03803202|143344933|OTHER||Ratio of GMT|0.45|||||TWO_SIDED|95.0|0.25|0.83|||t-test, 2 sided|||Serotype 6B, Day 30||0.83|0.25|
71912133|NCT03803202|143344933|OTHER||Ratio of GMT|0.43|||||TWO_SIDED|95.0|0.24|0.76|||t-test, 2 sided|||Serotype 6B, Day 30||0.76|0.24|
71912134|NCT03803202|143344933|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.51|1.29|||t-test, 2 sided|||Serotype 7F, Day 30||1.29|0.51|
71912135|NCT03803202|143344933|OTHER||Ratio of GMT|0.68|||||TWO_SIDED|95.0|0.47|0.99|||t-test, 2 sided|||Serotype 7F, Day 30||0.99|0.47|
71912136|NCT03803202|143344933|OTHER||Ratio of GMT|0.82|||||TWO_SIDED|95.0|0.53|1.25|||t-test, 2 sided|||Serotype 7F, Day 30||1.25|0.53|
71912137|NCT03803202|143344933|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.35|1.08|||t-test, 2 sided|||Serotype 9V, Day 30||1.08|0.35|
71912138|NCT03803202|143344933|OTHER||Ratio of GMT|0.57|||||TWO_SIDED|95.0|0.31|1.03|||t-test, 2 sided|||Serotype 9V, Day 30||1.03|0.31|
71912139|NCT03803202|143344933|OTHER||Ratio of GMT|0.77|||||TWO_SIDED|95.0|0.46|1.28|||t-test, 2 sided|||Serotype 9V, Day 30||1.28|0.46|
71912140|NCT03803202|143344933|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.27|1.08|||t-test, 2 sided|||Serotype 14, Day 30||1.08|0.27|
71912141|NCT03803202|143344933|OTHER||Ratio of GMT|0.28|||||TWO_SIDED|95.0|0.1|0.77|||t-test, 2 sided|||Serotype 14, Day 30||0.77|0.10|
71912142|NCT03803202|143344933|OTHER||Ratio of GMT|1.13|||||TWO_SIDED|95.0|0.56|2.3|||t-test, 2 sided|||Serotype 14, Day 30||2.30|0.56|
71912143|NCT03803202|143344933|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.53|1.5|||t-test, 2 sided|||Serotype 18C, Day 30||1.50|0.53|
71912144|NCT03803202|143344933|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.23|||t-test, 2 sided|||Serotype 18C, Day 30||1.23|0.39|
71912145|NCT03803202|143344933|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.5|1.28|||t-test, 2 sided|||Serotype 18C, Day 30||1.28|0.50|
71912146|NCT03803202|143344933|OTHER||Ratio of GMT|0.5|||||TWO_SIDED|95.0|0.32|0.79|||t-test, 2 sided|||Serotype 19A, Day 30||0.79|0.32|
71912147|NCT03803202|143344933|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.45|1.09|||t-test, 2 sided|||Serotype 19A, Day 30||1.09|0.45|
71912148|NCT03803202|143344933|OTHER||Ratio of GMT|0.63|||||TWO_SIDED|95.0|0.42|0.96|||t-test, 2 sided|||Serotype 19A, Day 30||0.96|0.42|
71912149|NCT03803202|143344933|OTHER||Ratio of GMT|0.56|||||TWO_SIDED|95.0|0.34|0.92|||t-test, 2 sided|||Serotype 19F, Day 30||0.92|0.34|
71912150|NCT03803202|143344933|OTHER||Ratio of GMT|0.64|||||TWO_SIDED|95.0|0.37|1.1|||t-test, 2 sided|||Serotype 19F, Day 30||1.10|0.37|
71912151|NCT03803202|143344933|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.56|1.55|||t-test, 2 sided|||Serotype 19F, Day 30||1.55|0.56|
71912152|NCT03803202|143344933|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.46|||t-test, 2 sided|||Serotype 23F, Day 30||0.46|0.08|
71912153|NCT03803202|143344933|OTHER||Ratio of GMT|0.2|||||TWO_SIDED|95.0|0.08|0.47|||t-test, 2 sided|||Serotype 23F, Day 30||0.47|0.08|
71912154|NCT03803202|143344933|OTHER||Ratio of GMT|0.23|||||TWO_SIDED|95.0|0.09|0.57|||t-test, 2 sided|||Serotype 23F, Day 30||0.57|0.09|
71912155|NCT03803202|143344934|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.52|2.23|||t-test, 2 sided|||Serotype 1, Day 1||2.23|0.52|
71912156|NCT03803202|143344934|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.51|1.98|||t-test, 2 sided|||Serotype 1, Day 1||1.98|0.51|
71912157|NCT03803202|143344934|OTHER||Ratio of GMC|1.43|||||TWO_SIDED|95.0|0.72|2.83|||t-test, 2 sided|||Serotype 1, Day 1||2.83|0.72|
71912158|NCT03803202|143344934|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.59|2.68|||t-test, 2 sided|||Serotype 3, Day 1||2.68|0.59|
71912159|NCT03803202|143344934|OTHER||Ratio of GMC|1.65|||||TWO_SIDED|95.0|0.9|3.05|||t-test, 2 sided|||Serotype 3, Day 1||3.05|0.90|
71912160|NCT03803202|143344934|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.68|2.25|||t-test, 2 sided|||Serotype 3, Day 1||2.25|0.68|
71912161|NCT03803202|143344934|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.49|2.15|||t-test, 2 sided|||Serotype 4, Day 1||2.15|0.49|
71912162|NCT03803202|143344934|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.39|1.74|||t-test, 2 sided|||Serotype 4, Day 1||1.74|0.39|
71912163|NCT03803202|143344934|OTHER||Ratio of GMC|1.24|||||TWO_SIDED|95.0|0.59|2.59|||t-test, 2 sided|||Serotype 4, Day 1||2.59|0.59|
71912164|NCT03803202|143344934|OTHER||Ratio of GMC|1.71|||||TWO_SIDED|95.0|0.75|3.91|||t-test, 2 sided|||Serotype 5, Day 1||3.91|0.75|
71912165|NCT03803202|143344934|OTHER||Ratio of GMC|0.72|||||TWO_SIDED|95.0|0.36|1.46|||t-test, 2 sided|||Serotype 5, Day 1||1.46|0.36|
71912166|NCT03803202|143344934|OTHER||Ratio of GMC|0.93|||||TWO_SIDED|95.0|0.47|1.84|||t-test, 2 sided|||Serotype 5, Day 1||1.84|0.47|
71912167|NCT03803202|143344934|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.57|2.52|||t-test, 2 sided|||Serotype 6A, Day 1||2.52|0.57|
71912168|NCT03803202|143344934|OTHER||Ratio of GMC|1.28|||||TWO_SIDED|95.0|0.64|2.56|||t-test, 2 sided|||Serotype 6A, Day 1||2.56|0.64|
71912169|NCT03803202|143344934|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.52|2.28|||t-test, 2 sided|||Serotype 6A, Day 1||2.28|0.52|
71912170|NCT03803202|143344934|OTHER||Ratio of GMC|1.23|||||TWO_SIDED|95.0|0.49|3.09|||t-test, 2 sided|||Serotype 6B, Day 1||3.09|0.49|
71912171|NCT03803202|143344934|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.43|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.43|
71912172|NCT03803202|143344934|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.37|1.73|||t-test, 2 sided|||Serotype 6B, Day 1||1.73|0.37|
71912173|NCT03803202|143344934|OTHER||Ratio of GMC|1.51|||||TWO_SIDED|95.0|0.76|3.01|||t-test, 2 sided|||Serotype 7F, Day 1||3.01|0.76|
71912174|NCT03803202|143344934|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.69|1.94|||t-test, 2 sided|||Serotype 7F, Day 1||1.94|0.69|
71912175|NCT03803202|143344934|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|0.98|2.91|||t-test, 2 sided|||Serotype 7F, Day 1||2.91|0.98|
71912176|NCT03803202|143344934|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.54|2.22|||t-test, 2 sided|||Serotype 9V, Day 1||2.22|0.54|
71912177|NCT03803202|143344934|OTHER||Ratio of GMC|0.74|||||TWO_SIDED|95.0|0.41|1.36|||t-test, 2 sided|||Serotype 9V, Day 1||1.36|0.41|
71912178|NCT03803202|143344934|OTHER||Ratio of GMC|0.85|||||TWO_SIDED|95.0|0.47|1.55|||t-test, 2 sided|||Serotype 9V, Day 1||1.55|0.47|
71912179|NCT03803202|143344934|OTHER||Ratio of GMC|2.05|||||TWO_SIDED|95.0|0.84|4.99|||t-test, 2 sided|||Serotype 14, Day 1||4.99|0.84|
71912180|NCT03803202|143344934|OTHER||Ratio of GMC|2.6|||||TWO_SIDED|95.0|1.13|5.98|||t-test, 2 sided|||Serotype 14, Day 1||5.98|1.13|
71912181|NCT03803202|143344934|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.37|2.15|||t-test, 2 sided|||Serotype 14, Day 1||2.15|0.37|
71912182|NCT03803202|143344934|OTHER||Ratio of GMC|1.37|||||TWO_SIDED|95.0|0.61|3.06|||t-test, 2 sided|||Serotype 18C, Day 1||3.06|0.61|
71912183|NCT03803202|143344934|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.55|2.09|||t-test, 2 sided|||Serotype 18C, Day 1||2.09|0.55|
71912184|NCT03803202|143344934|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.59|2.65|||t-test, 2 sided|||Serotype 18C, Day 1||2.65|0.59|
71912185|NCT03803202|143344934|OTHER||Ratio of GMC|1.61|||||TWO_SIDED|95.0|0.74|3.49|||t-test, 2 sided|||Serotype 19A, Day 1||3.49|0.74|
71682863|NCT05153148|142883829|SUPERIORITY||Risk Difference (RD)|9.1|||=|0.101|TWO_SIDED|95.0|-1.0|20.1|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||20.1|-1.0|=0.101
71867735|NCT00911937|143252759|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0001
71867736|NCT00911937|143252761|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.07||0.0827|TWO_SIDED|95.0|-0.25|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.01|-0.25|0.0827
71867737|NCT00911937|143252761|SUPERIORITY_OR_OTHER||Least Squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.07||0.0112|TWO_SIDED|95.0|-0.33|-0.04||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.04|-0.33|0.0112
71867738|NCT00911937|143252762|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0023
71867739|NCT00911937|143252764|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.15||0.0026|TWO_SIDED|95.0|-0.74|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-0.74|0.0026
71867740|NCT00911937|143252764|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.17||0.0014|TWO_SIDED|95.0|-0.9|-0.22||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.22|-0.90|0.0014
71867741|NCT00911937|143252765|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0016
71867742|NCT00911937|143252765|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0004
71867743|NCT00911937|143252767|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.22||0.0072|TWO_SIDED|95.0|-1.03|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.16|-1.03|0.0072
71867744|NCT00911937|143252767|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED|95.0|-1.25|-0.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.32|-1.25|0.0009
71867745|NCT00911937|143252768|SUPERIORITY_OR_OTHER|||||||0.0041|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||0.0041
71867746|NCT00911937|143252768|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.||||<0.0001
71867747|NCT00911937|143252770|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.17||0.3954|TWO_SIDED|95.0|-0.47|0.19||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.19|-0.47|0.3954
71867748|NCT00911937|143252770|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.15||0.2166|TWO_SIDED|95.0|-0.48|0.11||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.11|-0.48|0.2166
71912186|NCT03803202|143344934|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.42|1.65|||t-test, 2 sided|||Serotype 19A, Day 1||1.65|0.42|
71912187|NCT03803202|143344934|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.05|||t-test, 2 sided|||Serotype 19A, Day 1||2.05|0.49|
71912188|NCT03803202|143344934|OTHER||Ratio of GMC|1.47|||||TWO_SIDED|95.0|0.63|3.39|||t-test, 2 sided|||Serotype 19F, Day 1||3.39|0.63|
71682864|NCT05153148|142883829|SUPERIORITY||Risk Difference (RD)|8.3|||=|0.158|TWO_SIDED|95.0|-1.7|19.4|||Fisher Exact||Comparisons of ACR70 responder rates at Week 12 were made independently between each dose group and the placebo group using Fischer's exact Method.|||19.4|-1.7|=0.158
71682865|NCT05153148|142883830|SUPERIORITY||Treatment Difference|-1.7|||=|0.268|TWO_SIDED|95.0|-4.8|1.3|||Mixed Model Repeated Measure (MMRM)||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-4.8|=0.268
71867749|NCT00911937|143252773|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.24||0.1018|TWO_SIDED|95.0|-0.85|0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||0.08|-0.85|0.1018
71867750|NCT00911937|143252773|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.24||0.0027|TWO_SIDED|95.0|-1.2|-0.25||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.25|-1.20|0.0027
71912189|NCT03803202|143344934|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.64|3.07|||t-test, 2 sided|||Serotype 19F, Day 1||3.07|0.64|
71912190|NCT03803202|143344934|OTHER||Ratio of GMC|1.12|||||TWO_SIDED|95.0|0.53|2.34|||t-test, 2 sided|||Serotype 19F, Day 1||2.34|0.53|
71912191|NCT03803202|143344934|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.49|2.09|||t-test, 2 sided|||Serotype 23F, Day 1||2.09|0.49|
71912192|NCT03803202|143344934|OTHER||Ratio of GMC|0.94|||||TWO_SIDED|95.0|0.5|1.75|||t-test, 2 sided|||Serotype 23F, Day 1||1.75|0.50|
71912193|NCT03803202|143344934|OTHER||Ratio of GMC|0.91|||||TWO_SIDED|95.0|0.42|2.0|||t-test, 2 sided|||Serotype 23F, Day 1||2.00|0.42|
71912194|NCT03803202|143344934|OTHER||Ratio of GMC|0.7|||||TWO_SIDED|95.0|0.38|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.38|
71912195|NCT03803202|143344934|OTHER||Ratio of GMC|0.95|||||TWO_SIDED|95.0|0.52|1.73|||t-test, 2 sided|||Serotype 1, Day 30||1.73|0.52|
71912196|NCT03803202|143344934|OTHER||Ratio of GMC|1.5|||||TWO_SIDED|95.0|0.84|2.66|||t-test, 2 sided|||Serotype 1, Day 30||2.66|0.84|
71912197|NCT03803202|143344934|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.84|2.28|||t-test, 2 sided|||Serotype 3, Day 30||2.28|0.84|
71912198|NCT03803202|143344934|OTHER||Ratio of GMC|2.68|||||TWO_SIDED|95.0|1.71|4.19|||t-test, 2 sided|||Serotype 3, Day 30||4.19|1.71|
71912199|NCT03803202|143344934|OTHER||Ratio of GMC|3.87|||||TWO_SIDED|95.0|2.47|6.06|||t-test, 2 sided|||Serotype 3, Day 30||6.06|2.47|
71912200|NCT03803202|143344934|OTHER||Ratio of GMC|1.27|||||TWO_SIDED|95.0|0.7|2.3|||t-test, 2 sided|||Serotype 4, Day 30||2.30|0.70|
71912201|NCT03803202|143344934|OTHER||Ratio of GMC|1.02|||||TWO_SIDED|95.0|0.57|1.81|||t-test, 2 sided|||Serotype 4, Day 30||1.81|0.57|
71912202|NCT03803202|143344934|OTHER||Ratio of GMC|2.24|||||TWO_SIDED|95.0|1.21|4.15|||t-test, 2 sided|||Serotype 4, Day 30||4.15|1.21|
71912203|NCT03803202|143344934|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.7|3.57|||t-test, 2 sided|||Serotype 5, Day 30||3.57|0.70|
71912204|NCT03803202|143344934|OTHER||Ratio of GMC|0.84|||||TWO_SIDED|95.0|0.35|2.05|||t-test, 2 sided|||Serotype 5, Day 30||2.05|0.35|
71912205|NCT03803202|143344934|OTHER||Ratio of GMC|1.49|||||TWO_SIDED|95.0|0.65|3.39|||t-test, 2 sided|||Serotype 5, Day 30||3.39|0.65|
71912206|NCT03803202|143344934|OTHER||Ratio of GMC|0.89|||||TWO_SIDED|95.0|0.41|1.93|||t-test, 2 sided|||Serotype 6A, Day 30||1.93|0.41|
71912207|NCT03803202|143344934|OTHER||Ratio of GMC|0.77|||||TWO_SIDED|95.0|0.33|1.79|||t-test, 2 sided|||Serotype 6A, Day 30||1.79|0.33|
71912208|NCT03803202|143344934|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.32|1.48|||t-test, 2 sided|||Serotype 6A, Day 30||1.48|0.32|
71912209|NCT03803202|143344934|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.57|2.83|||t-test, 2 sided|||Serotype 6B, Day 30||2.83|0.57|
71912210|NCT03803202|143344934|OTHER||Ratio of GMC|0.75|||||TWO_SIDED|95.0|0.31|1.81|||t-test, 2 sided|||Serotype 6B, Day 30||1.81|0.31|
71912211|NCT03803202|143344934|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.39|1.97|||t-test, 2 sided|||Serotype 6B, Day 30||1.97|0.39|
71912212|NCT03803202|143344934|OTHER||Ratio of GMC|1.86|||||TWO_SIDED|95.0|1.05|3.3|||t-test, 2 sided|||Serotype 7F, Day 30||3.30|1.05|
71912213|NCT03803202|143344934|OTHER||Ratio of GMC|1.98|||||TWO_SIDED|95.0|1.1|3.55|||t-test, 2 sided|||Serotype 7F, Day 30||3.55|1.10|
71912214|NCT03803202|143344934|OTHER||Ratio of GMC|2.88|||||TWO_SIDED|95.0|1.62|5.12|||t-test, 2 sided|||Serotype 7F, Day 30||5.12|1.62|
71912215|NCT03803202|143344934|OTHER||Ratio of GMC|0.96|||||TWO_SIDED|95.0|0.49|1.87|||t-test, 2 sided|||Serotype 9V, Day 30||1.87|0.49|
71912216|NCT03803202|143344934|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.74|2.62|||t-test, 2 sided|||Serotype 9V, Day 30||2.62|0.74|
71912217|NCT03803202|143344934|OTHER||Ratio of GMC|1.68|||||TWO_SIDED|95.0|0.87|3.27|||t-test, 2 sided|||Serotype 9V, Day 30||3.27|0.87|
71912218|NCT03803202|143344934|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.41|2.53|||t-test, 2 sided|||Serotype 14, Day 30||2.53|0.41|
71912219|NCT03803202|143344934|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.45|2.6|||t-test, 2 sided|||Serotype 14, Day 30||2.60|0.45|
71912220|NCT03803202|143344934|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|0.86|5.04|||t-test, 2 sided|||Serotype 14, Day 30||5.04|0.86|
71912221|NCT03803202|143344934|OTHER||Ratio of GMC|1.09|||||TWO_SIDED|95.0|0.57|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.57|
71912222|NCT03803202|143344934|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.53|1.89|||t-test, 2 sided|||Serotype 18C, Day 30||1.89|0.53|
71912223|NCT03803202|143344934|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.56|2.07|||t-test, 2 sided|||Serotype 18C, Day 30||2.07|0.56|
71912224|NCT03803202|143344934|OTHER||Ratio of GMC|0.68|||||TWO_SIDED|95.0|0.4|1.14|||t-test, 2 sided|||Serotype 19A, Day 30||1.14|0.40|
71912225|NCT03803202|143344934|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.46|1.61|||t-test, 2 sided|||Serotype 19A, Day 30||1.61|0.46|
71912226|NCT03803202|143344934|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.47|1.6|||t-test, 2 sided|||Serotype 19A, Day 30||1.60|0.47|
71912227|NCT03803202|143344934|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.49|2.01|||t-test, 2 sided|||Serotype 19F, Day 30||2.01|0.49|
71912228|NCT03803202|143344934|OTHER||Ratio of GMC|1.38|||||TWO_SIDED|95.0|0.75|2.53|||t-test, 2 sided|||Serotype 19F, Day 30||2.53|0.75|
71912229|NCT03803202|143344934|OTHER||Ratio of GMC|1.41|||||TWO_SIDED|95.0|0.68|2.96|||t-test, 2 sided|||Serotype 19F, Day 30||2.96|0.68|
71912230|NCT03803202|143344934|OTHER||Ratio of GMC|0.46|||||TWO_SIDED|95.0|0.2|1.07|||t-test, 2 sided|||Serotype 23F, Day 30||1.07|0.20|
71912231|NCT03803202|143344934|OTHER||Ratio of GMC|0.5|||||TWO_SIDED|95.0|0.22|1.11|||t-test, 2 sided|||Serotype 23F, Day 30||1.11|0.22|
71912232|NCT03803202|143344934|OTHER||Ratio of GMC|0.64|||||TWO_SIDED|95.0|0.29|1.44|||t-test, 2 sided|||Serotype 23F, Day 30||1.44|0.29|
71912233|NCT03803202|143344938|OTHER||Ratio of GMT|0.8|||||TWO_SIDED|95.0|0.56|1.14|||t-test, 2 sided|||Serotype 1, Day 1||1.14|0.56|
71912234|NCT03803202|143344938|OTHER||Ratio of GMT|1.39|||||TWO_SIDED|95.0|0.89|2.16|||t-test, 2 sided|||Serotype 1, Day 1||2.16|0.89|
71912235|NCT03803202|143344938|OTHER||Ratio of GMT|0.73|||||TWO_SIDED|95.0|0.51|1.06|||t-test, 2 sided|||Serotype 1, Day 1||1.06|0.51|
71912236|NCT03803202|143344938|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.85|2.09|||t-test, 2 sided|||Serotype 3, Day 1||2.09|0.85|
71912237|NCT03803202|143344938|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.91|2.3|||t-test, 2 sided|||Serotype 3, Day 1||2.30|0.91|
71912238|NCT03803202|143344938|OTHER||Ratio of GMT|0.95|||||TWO_SIDED|95.0|0.6|1.49|||t-test, 2 sided|||Serotype 3, Day 1||1.49|0.60|
71912239|NCT03803202|143344938|OTHER||Ratio of GMT|0.81|||||TWO_SIDED|95.0|0.46|1.4|||t-test, 2 sided|||Serotype 4, Day 1||1.40|0.46|
71912240|NCT03803202|143344938|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.62|1.91|||t-test, 2 sided|||Serotype 4, Day 1||1.91|0.62|
71912241|NCT03803202|143344938|OTHER||Ratio of GMT|0.7|||||TWO_SIDED|95.0|0.4|1.23|||t-test, 2 sided|||Serotype 4, Day 1||1.23|0.40|
71912242|NCT03803202|143344938|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 5, Day 1||1.68|0.58|
71912243|NCT03803202|143344938|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.76|2.29|||t-test, 2 sided|||Serotype 5, Day 1||2.29|0.76|
71912244|NCT03803202|143344938|OTHER||Ratio of GMT|0.88|||||TWO_SIDED|95.0|0.51|1.53|||t-test, 2 sided|||Serotype 5, Day 1||1.53|0.51|
71912245|NCT03803202|143344938|OTHER||Ratio of GMT|0.96|||||TWO_SIDED|95.0|0.54|1.72|||t-test, 2 sided|||Serotype 6A, Day 1||1.72|0.54|
71912246|NCT03803202|143344938|OTHER||Ratio of GMT|1.1|||||TWO_SIDED|95.0|0.57|2.14|||t-test, 2 sided|||Serotype 6B, Day 1||2.14|0.57|
71912247|NCT03803202|143344938|OTHER||Ratio of GMT|1.63|||||TWO_SIDED|95.0|0.86|3.1|||t-test, 2 sided|||Serotype 6A, Day 1||3.10|0.86|
71912248|NCT03803202|143344938|OTHER||Ratio of GMT|1.61|||||TWO_SIDED|95.0|0.83|3.14|||t-test, 2 sided|||Serotype 6A, Day 1||3.14|0.83|
71912249|NCT03803202|143344938|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.59|2.24|||t-test, 2 sided|||Serotype 6B, Day 1||2.24|0.59|
71912250|NCT03803202|143344938|OTHER||Ratio of GMT|1.18|||||TWO_SIDED|95.0|0.58|2.39|||t-test, 2 sided|||Serotype 6B, Day 1||2.39|0.58|
71912251|NCT03803202|143344938|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.4|1.8|||t-test, 2 sided|||Serotype 7F, Day 1||1.80|0.40|
71912252|NCT03803202|143344938|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.63|2.87|||t-test, 2 sided|||Serotype 7F, Day 1||2.87|0.63|
71912253|NCT03803202|143344938|OTHER||Ratio of GMT|1.03|||||TWO_SIDED|95.0|0.45|2.37|||t-test, 2 sided|||Serotype 7F, Day 1||2.37|0.45|
71912254|NCT03803202|143344938|OTHER||Ratio of GMT|0.65||||||95.0|0.32|1.32|||t-test, 2 sided|||Serotype 9V, Day 1||1.32|0.32|
71912255|NCT03803202|143344938|OTHER||Ratio of GMT|0.78|||||TWO_SIDED|95.0|0.37|1.64|||t-test, 2 sided|||Serotype 9V, Day 1||1.64|0.37|
71912256|NCT03803202|143344938|OTHER||Ratio of GMT|0.66|||||TWO_SIDED|95.0|0.3|1.49|||t-test, 2 sided|||Serotype 9V, Day 1||1.49|0.30|
71912257|NCT03803202|143344938|OTHER||Ratio of GMT|0.61|||||TWO_SIDED|95.0|0.31|1.18|||t-test, 1 sided|||Serotype 14, Day 1||1.18|0.31|
71912258|NCT03803202|143344938|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.54|2.18|||t-test, 2 sided|||Serotype 14, Day 1||2.18|0.54|
71912259|NCT03803202|143344938|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.66|2.65|||t-test, 2 sided|||Serotype 14, Day 1||2.65|0.66|
71912260|NCT03803202|143344938|OTHER||Ratio of GMT|0.54|||||TWO_SIDED|95.0|0.3|0.95|||t-test, 2 sided|||Serotype 18C, Day 1||0.95|0.30|
71912261|NCT03803202|143344938|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.73|2.57|||t-test, 2 sided|||Serotype 18C, Day 1||2.57|0.73|
71912262|NCT03803202|143344938|OTHER||Ratio of GMT|0.58|||||TWO_SIDED|95.0|0.32|1.04|||t-test, 2 sided|||Serotype 18C, Day 1||1.04|0.32|
71912263|NCT03803202|143344938|OTHER||Ratio of GMT|0.76|||||TWO_SIDED|95.0|0.44|1.32|||t-test, 2 sided|||Serotype 19A, Day 1||1.32|0.44|
71912264|NCT03803202|143344938|OTHER||Ratio of GMT|1.15|||||TWO_SIDED|95.0|0.66|2.01|||t-test, 2 sided|||Serotype 19A, Day 1||2.01|0.66|
71912265|NCT03803202|143344938|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.48|1.5|||t-test, 2 sided|||Serotype 19A, Day 1||1.50|0.48|
71912266|NCT03803202|143344938|OTHER||Ratio of GMT|0.79|||||TWO_SIDED|95.0|0.45|1.38|||t-test, 2 sided|||Serotype 19F, Day 1||1.38|0.45|
71912267|NCT03803202|143344938|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.47|1.52|||t-test, 2 sided|||Serotype 19F, Day 1||1.52|0.47|
71912268|NCT03803202|143344938|OTHER||Ratio of GMT|0.62|||||TWO_SIDED|95.0|0.34|1.12|||t-test, 2 sided|||Serotype 19F, Day 1||1.12|0.34|
71912269|NCT03803202|143344938|OTHER||Ratio of GMT|1.11|||||TWO_SIDED|95.0|0.64|1.94|||t-test, 2 sided|||Serotype 23F, Day 1||1.94|0.64|
71912270|NCT03803202|143344938|OTHER||Ratio of GMT|1.37|||||TWO_SIDED|95.0|0.77|2.42|||t-test, 2 sided|||Serotype 23F, Day 1||2.42|0.77|
71912271|NCT03803202|143344938|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.66|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.66|
71912272|NCT03803202|143344938|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.47|1.47|||t-test, 2 sided|||Serotype 1, Day 30||1.47|0.47|
71912273|NCT03803202|143344938|OTHER||Ratio of GMT|0.87|||||TWO_SIDED|95.0|0.5|1.53|||t-test, 2 sided|||Serotype 1, Day 30||1.53|0.50|
71912274|NCT03803202|143344938|OTHER||Ratio of GMT|1.28|||||TWO_SIDED|95.0|0.74|2.2|||t-test, 2 sided|||Serotype 1, Day 30||2.20|0.74|
71682866|NCT05153148|142883830|SUPERIORITY||Treatment Difference|-3.0|||=|0.051|TWO_SIDED|95.0|-6.1|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-6.1|=0.051
71682867|NCT05153148|142883830|SUPERIORITY||Treatment Difference|-2.5|||=|0.112|TWO_SIDED|95.0|-5.6|0.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.6|-5.6|=0.112
71867751|NCT00911937|143252775|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.63||0.0131|TWO_SIDED|95.0|-2.79|-0.33||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-0.33|-2.79|0.0131
71867752|NCT00911937|143252775|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.43|STANDARD_ERROR_OF_MEAN|0.69||0.0004|TWO_SIDED|95.0|-3.78|-1.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.08|-3.78|0.0004
71912275|NCT03803202|143344938|OTHER||Ratio of GMT|25.03|||||TWO_SIDED|95.0|16.33|38.34|||t-test, 2 sided|||Serotype 2, Day 30||38.34|16.33|
71912276|NCT03803202|143344938|OTHER||Ratio of GMT|21.99|||||TWO_SIDED|95.0|14.31|33.77|||t-test, 2 sided|||Serotype 2, Day 30||33.77|14.31|
71912277|NCT03803202|143344938|OTHER||Ratio of GMT|35.38|||||TWO_SIDED|95.0|23.09|54.22|||t-test, 2 sided|||Serotype 2, Day 30||54.22|23.09|
71912278|NCT03803202|143344938|OTHER||Ratio of GMT|1.81|||||TWO_SIDED|95.0|1.25|2.62|||t-test, 2 sided|||Serotype 3, Day 30||2.62|1.25|
71912279|NCT03803202|143344938|OTHER||Ratio of GMT|2.55|||||TWO_SIDED|95.0|1.83|3.56|||t-test, 2 sided|||Serotype 3, Day 30||3.56|1.83|
71912280|NCT03803202|143344938|OTHER||Ratio of GMT|3.14|||||TWO_SIDED|95.0|2.2|4.48|||t-test, 2 sided|||Serotype 3, Day 30||4.48|2.20|
71912281|NCT03803202|143344938|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.59|1.62|||t-test, 2 sided|||Serotype 4, Day 30||1.62|0.59|
71912282|NCT03803202|143344938|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 4, Day 30||1.51|0.59|
71912283|NCT03803202|143344938|OTHER||Ratio of GMT|1.23|||||TWO_SIDED|95.0|0.76|1.99|||t-test, 2 sided|||Serotype 4, Day 30||1.99|0.76|
71682868|NCT05153148|142883831|SUPERIORITY||Treatment Difference|-0.9|||=|0.28|TWO_SIDED|95.0|-2.4|0.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.7|-2.4|=0.280
71912284|NCT03803202|143344938|OTHER||Ratio of GMT|1.25|||||TWO_SIDED|95.0|0.71|2.21|||t-test, 2 sided|||Serotype 5, Day 30||2.21|0.71|
71912285|NCT03803202|143344938|OTHER||Ratio of GMT|1.45|||||TWO_SIDED|95.0|0.85|2.46|||t-test, 2 sided|||Serotype 5, Day 30||2.46|0.85|
71912286|NCT03803202|143344938|OTHER||Ratio of GMT|2.15|||||TWO_SIDED|95.0|1.25|3.72|||t-test, 2 sided|||Serotype 5, Day 30||3.72|1.25|
71912287|NCT03803202|143344938|OTHER||Ratio of GMT|0.94|||||TWO_SIDED|95.0|0.59|1.51|||t-test, 2 sided|||Serotype 6B, Day 30||1.51|0.59|
71912288|NCT03803202|143344938|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.56|1.29|||t-test, 2 sided|||Serotype 6B, Day 30||1.29|0.56|
71912289|NCT03803202|143344938|OTHER||Ratio of GMT|0.84|||||TWO_SIDED|95.0|0.54|1.3|||t-test, 2 sided|||Serotype 6B, Day 30||1.30|0.54|
71912290|NCT03803202|143344938|OTHER||Ratio of GMT|0.85|||||TWO_SIDED|95.0|0.61|1.18|||t-test, 2 sided|||Serotype 7F, Day 30||1.18|0.61|
71912291|NCT03803202|143344938|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.65|1.21|||t-test, 2 sided|||Serotype 7F, Day 30||1.21|0.65|
71912292|NCT03803202|143344938|OTHER||Ratio of GMT|1.05|||||TWO_SIDED|95.0|0.73|1.5|||t-test, 2 sided|||Serotype 7F, Day 30||1.50|0.73|
71912293|NCT03803202|143344938|OTHER||Ratio of GMT|19.46|||||TWO_SIDED|95.0|12.26|30.87|||t-test, 2 sided|||Serotype 8, Day 30||30.87|12.26|
71912294|NCT03803202|143344938|OTHER||Ratio of GMT|19.65|||||TWO_SIDED|95.0|12.07|32.0|||t-test, 2 sided|||Serotype 8, Day 30||32.00|12.07|
71912295|NCT03803202|143344938|OTHER||Ratio of GMT|41.87|||||TWO_SIDED|95.0|26.2|66.9|||t-test, 2 sided|||Serotype 8, Day 30||66.90|26.20|
71912296|NCT03803202|143344938|OTHER||Ratio of GMT|4.75|||||TWO_SIDED|95.0|3.06|7.36|||t-test, 2 sided|||Serotype 9N, Day 30||7.36|3.06|
71912297|NCT03803202|143344938|OTHER||Ratio of GMT|5.66|||||TWO_SIDED|95.0|3.83|8.37|||t-test, 2 sided|||Serotype 9N, Day 30||8.37|3.83|
71912298|NCT03803202|143344938|OTHER||Ratio of GMT|7.84|||||TWO_SIDED|95.0|5.19|11.82|||t-test, 2 sided|||Serotype 9N, Day 30||11.82|5.19|
71912299|NCT03803202|143344938|OTHER||Ratio of GMT|0.83|||||TWO_SIDED|95.0|0.49|1.42|||t-test, 2 sided|||Serotype 9V, Day 30||1.42|0.49|
71912300|NCT03803202|143344938|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.44|1.14|||t-test, 2 sided|||Serotype 9V, Day 30||1.14|0.44|
71912301|NCT03803202|143344938|OTHER||Ratio of GMT|1.21|||||TWO_SIDED|95.0|0.76|1.95|||t-test, 2 sided|||Serotype 9V, Day 30||1.95|0.76|
71912302|NCT03803202|143344938|OTHER||Ratio of GMT|0.69|||||TWO_SIDED|95.0|0.39|1.21|||t-test, 2 sided|||Serotype 6A, Day 30||1.21|0.39|
71912303|NCT03803202|143344938|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.5|||t-test, 2 sided|||Serotype 6A, Day 30||1.50|0.54|
71912304|NCT03803202|143344938|OTHER||Ratio of GMT|0.93|||||TWO_SIDED|95.0|0.53|1.64|||t-test, 2 sided|||Serotype 6A, Day 30||1.64|0.53|
71912305|NCT03803202|143344938|OTHER||Ratio of GMT|1.33|||||TWO_SIDED|95.0|0.84|2.11|||t-test, 2 sided|||Serotype 14, Day 30||2.11|0.84|
71912306|NCT03803202|143344938|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.43|||t-test, 2 sided|||Serotype 14, Day 30||1.43|0.55|
71912307|NCT03803202|143344938|OTHER||Ratio of GMT|1.54|||||TWO_SIDED|95.0|0.95|2.5|||t-test, 2 sided|||Serotype 14, Day 30||2.50|0.95|
71912308|NCT03803202|143344938|OTHER||Ratio of GMT|0.89|||||TWO_SIDED|95.0|0.55|1.44|||t-test, 2 sided|||Serotype 18C, Day 30||1.44|0.55|
71912309|NCT03803202|143344938|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.63|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.63|
71912310|NCT03803202|143344938|OTHER||Ratio of GMT|1.32|||||TWO_SIDED|95.0|0.82|2.12|||t-test, 2 sided|||Serotype 18C, Day 30||2.12|0.82|
71867753|NCT00911937|143252777|SUPERIORITY_OR_OTHER||Least squares mean difference|1.32|STANDARD_ERROR_OF_MEAN|7.2||0.8547|TWO_SIDED|95.0|-12.82|15.46||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||15.46|-12.82|0.8547
71867754|NCT00911937|143252779|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.22||0.8396|TWO_SIDED|95.0|-9.14|7.44||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||7.44|-9.14|0.8396
71867755|NCT00911937|143252781|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.37|STANDARD_ERROR_OF_MEAN|1.26||0.0006|TWO_SIDED|95.0|-6.84|-1.89||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||-1.89|-6.84|0.0006
71867756|NCT00911937|143252783|SUPERIORITY_OR_OTHER||Least squares mean difference|3.42|STANDARD_ERROR_OF_MEAN|1.34||0.011|TWO_SIDED|95.0|0.79|6.05||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.05|0.79|0.0110
71867757|NCT00911937|143252783|SUPERIORITY_OR_OTHER||Least squares mean difference|3.14|STANDARD_ERROR_OF_MEAN|1.35||0.02|TWO_SIDED|95.0|0.5|5.79||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.79|0.50|0.0200
71867758|NCT00911937|143252783|SUPERIORITY_OR_OTHER||Least squares mean difference|3.48|STANDARD_ERROR_OF_MEAN|1.51||0.0218|TWO_SIDED|95.0|0.51|6.45||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||6.45|0.51|0.0218
71867759|NCT00911937|143252783|SUPERIORITY_OR_OTHER||Least squares mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.93||0.0458|TWO_SIDED|95.0|0.03|3.68||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||3.68|0.03|0.0458
71867760|NCT00911937|143252783|SUPERIORITY_OR_OTHER||Least squares mean difference|3.02|STANDARD_ERROR_OF_MEAN|1.17||0.01|TWO_SIDED|95.0|0.72|5.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.||5.32|0.72|0.0100
71867761|NCT01498679|143252789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|51.0|||<|0.001|TWO_SIDED|95.0|42.2|59.7|||ANCOVA|||||59.7|42.2|<0.001
71867762|NCT00620282|143252833|SUPERIORITY_OR_OTHER||Least squares mean|7.43||||0.0549||95.0|-0.164|15.025||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||15.025|-0.164|0.0549
71867763|NCT00620282|143252833|SUPERIORITY_OR_OTHER||Least squares mean|2.08||||0.5681||95.0|-5.215|9.375||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||9.375|-5.215|0.5681
71867764|NCT00620282|143252833|SUPERIORITY_OR_OTHER||Least squares mean|5.35||||0.1668||95.0|-2.323|13.024||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||13.024|-2.323|0.1668
71867765|NCT00620282|143252834|SUPERIORITY_OR_OTHER||Least squares mean|4.499||||0.2648||95.0|-3.535|12.534||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||12.534|-3.535|0.2648
71867766|NCT00620282|143252834|SUPERIORITY_OR_OTHER||Least squares mean|0.709||||0.8518||95.0|-6.904|8.322||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||8.322|-6.904|0.8518
71912311|NCT03803202|143344938|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.7|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.70|
71912312|NCT03803202|143344938|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.71|1.37|||t-test, 2 sided|||Serotype 19A, Day 30||1.37|0.71|
71867767|NCT00620282|143252834|SUPERIORITY_OR_OTHER||Least squares mean|3.79||||0.3435||95.0|-4.194|11.774||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.||11.774|-4.194|0.3435
71867768|NCT00620282|143252835|SUPERIORITY_OR_OTHER||Least squares mean|-0.536||||0.0023||95.0|-0.868|-0.203||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.203|-0.868|0.0023
71867769|NCT00620282|143252835|SUPERIORITY_OR_OTHER||Least squares mean|-0.077||||0.6207||95.0|-0.391|0.236||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||0.236|-0.391|0.6207
71867770|NCT00620282|143252835|SUPERIORITY_OR_OTHER||Least squares mean|-0.458||||0.0098||95.0|-0.8|-0.116||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.||-0.116|-0.8|0.0098
71912313|NCT03803202|143344938|OTHER||Ratio of GMT|1.14|||||TWO_SIDED|95.0|0.78|1.67|||t-test, 2 sided|||Serotype 19A, Day 30||1.67|0.78|
71912314|NCT03803202|143344938|OTHER||Ratio of GMT|1.52||||||95.0|0.99|2.32|||t-test, 2 sided|||Serotype 19F, Day 30||2.32|0.99|
71912315|NCT03803202|143344938|OTHER||Ratio of GMT|1.48|||||TWO_SIDED|95.0|1.0|2.18|||t-test, 2 sided|||Serotype 19F, Day 30||2.18|1.00|
71912316|NCT03803202|143344938|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.35|3.22|||t-test, 2 sided|||Serotype 19F, Day 30||3.22|1.35|
71867771|NCT00620282|143252836|SUPERIORITY_OR_OTHER||Least squares mean|-35.605||||||95.0|-46.797|-24.413||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-24.413|-46.797|
71867772|NCT00620282|143252836|SUPERIORITY_OR_OTHER||Least squares mean|-9.653||||0.0677||95.0|-20.041|0.736||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||0.736|-20.041|0.0677
71867773|NCT00620282|143252836|SUPERIORITY_OR_OTHER||Least squares mean|-25.952||||||95.0|-37.429|-14.475||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.||-14.475|-37.429|
71867774|NCT00620282|143252837|SUPERIORITY_OR_OTHER||Least squares mean|-11.871||||0.4121||95.0|-40.943|17.201||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||17.201|-40.943|0.4121
71867775|NCT00620282|143252837|SUPERIORITY_OR_OTHER||Least squares mean|3.815||||0.7622||95.0|-21.618|29.247||2-sided significance level of 5%|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||29.247|-21.618|0.7622
71867776|NCT00620282|143252837|SUPERIORITY_OR_OTHER||Least squares mean|-15.686||||0.2651||95.0|-43.838|12.466||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.||12.466|-43.838|0.2651
71867777|NCT00620282|143252838|SUPERIORITY_OR_OTHER||Least squares mean|-1.528||||0.0268||95.0|-2.873|-0.184||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-0.184|-2.873|0.0268
71867778|NCT00620282|143252838|SUPERIORITY_OR_OTHER||Least squares mean|-2.859||||||95.0|-4.139|-1.579||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||-1.579|-4.139|
71867779|NCT00620282|143252838|SUPERIORITY_OR_OTHER||Least squares mean|1.331||||0.0486||95.0|0.009|2.653||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.||2.653|0.0090|0.0486
71867780|NCT00620282|143252839|SUPERIORITY_OR_OTHER||Least squares mean|-2.237||||0.7736||95.0|-17.829|13.354||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||13.354|-17.829|0.7736
71867781|NCT00620282|143252839|SUPERIORITY_OR_OTHER||Least squares mean|1.912||||0.7993||95.0|-13.168|16.991||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||16.991|-13.168|0.7993
71867782|NCT00620282|143252839|SUPERIORITY_OR_OTHER||Least squares mean|-4.149||||0.5903||95.0|-19.582|11.284||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.||11.284|-19.582|0.5903
71867783|NCT00620282|143252840|SUPERIORITY_OR_OTHER||Least squares mean|3.702||||0.5583||95.0|-8.96|16.365||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||16.365|-8.96|0.5583
71867784|NCT00620282|143252840|SUPERIORITY_OR_OTHER||Least squares mean|2.773||||0.6517||95.0|-9.537|15.082||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||15.082|-9.537|0.6517
71867785|NCT00620282|143252840|SUPERIORITY_OR_OTHER||Least squares mean|0.929||||0.8822||95.0|-11.646|13.505||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.||13.505|-11.646|0.8822
71867786|NCT00620282|143252841|SUPERIORITY_OR_OTHER||Least squares mean|-0.169||||0.9131||95.0|-3.273|2.935||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.935|-3.273|0.9131
71867787|NCT00620282|143252841|SUPERIORITY_OR_OTHER||Least squares mean|-0.723||||0.6362||95.0|-3.785|2.339||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||2.339|-3.785|0.6362
71867788|NCT00620282|143252841|SUPERIORITY_OR_OTHER||Least squares mean|0.554||||0.7283||95.0|-2.643|3.751||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.||3.751|-2.643|0.7283
71867789|NCT00620282|143252842|SUPERIORITY_OR_OTHER||Least squares mean|-36.709||||0.0694||95.0|-76.467|3.048||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||3.048|-76.467|0.0694
71912317|NCT03803202|143344938|OTHER||Ratio of GMT|0.67|||||TWO_SIDED|95.0|0.36|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.36|
71912318|NCT03803202|143344938|OTHER||Ratio of GMT|0.71|||||TWO_SIDED|95.0|0.4|1.26|||t-test, 2 sided|||Serotype 23F, Day 30||1.26|0.40|
71912319|NCT03803202|143344938|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.47|1.73|||t-test, 2 sided|||Serotype 23F, Day 30||1.73|0.47|
71912320|NCT03803202|143344939|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.57|1.42|||t-test, 2 sided|||Serotype 1, Day 1||1.42|0.57|
71867790|NCT00620282|143252842|SUPERIORITY_OR_OTHER||Least squares mean|-3.786||||0.844||95.0|-42.373|34.801||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||34.801|-42.373|0.844
71682869|NCT05153148|142883831|SUPERIORITY||Treatment Difference|-1.1|||=|0.177|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.177
71867791|NCT00620282|143252842|SUPERIORITY_OR_OTHER||Least squares mean|-32.923||||0.0994||95.0|-72.353|6.507||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.||6.507|-72.353|0.0994
71912321|NCT03803202|143344939|OTHER||Ratio of GMC|1.85|||||TWO_SIDED|95.0|1.12|3.08|||t-test, 2 sided|||Serotype 1, Day 1||3.08|1.12|
71912322|NCT03803202|143344939|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.49|||t-test, 2 sided|||Serotype 1, Day 1||1.49|0.53|
71912323|NCT03803202|143344939|OTHER||Ratio of GMC|1.25|||||TWO_SIDED|95.0|0.84|1.87|||t-test, 2 sided|||Serotype 3, Day 1||1.87|0.84|
71912324|NCT03803202|143344939|OTHER||Ratio of GMC|1.79|||||TWO_SIDED|95.0|1.18|2.73|||t-test, 2 sided|||Serotype 3, Day 1||2.73|1.18|
71912325|NCT03803202|143344939|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.69|1.69|||t-test, 2 sided|||Serotype 3, Day 1||1.69|0.69|
71912326|NCT03803202|143344939|OTHER||Ratio of GMC|0.81|||||TWO_SIDED|95.0|0.54|1.21|||t-test, 2 sided|||Serotype 4, Day 1||1.21|0.54|
71912327|NCT03803202|143344939|OTHER||Ratio of GMC|1.16|||||TWO_SIDED|95.0|0.74|1.81|||t-test, 2 sided|||Serotype 4, Day 1||1.81|0.74|
71912328|NCT03803202|143344939|OTHER||Ratio of GMC|0.67|||||TWO_SIDED|95.0|0.44|1.0|||t-test, 2 sided|||Serotype 4, Day 1||1.00|0.44|
71912329|NCT03803202|143344939|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.65|1.78|||t-test, 2 sided|||Serotype 5, Day 1||1.78|0.65|
71912330|NCT03803202|143344939|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.96|2.63|||t-test, 2 sided|||Serotype 5, Day 1||2.63|0.96|
71912331|NCT03803202|143344939|OTHER||Ratio of GMC|1.0|||||TWO_SIDED|95.0|0.58|1.72|||t-test, 2 sided|||Serotype 5, Day 1||1.72|0.58|
71912332|NCT03803202|143344939|OTHER||Ratio of GMC|0.88|||||TWO_SIDED|95.0|0.53|1.47|||t-test, 2 sided|||Serotype 6A, Day 1||1.47|0.53|
71912333|NCT03803202|143344939|OTHER||Ratio of GMC|1.39|||||TWO_SIDED|95.0|0.83|2.3|||t-test, 2 sided|||Serotype 6A, Day 1||2.30|0.83|
71912334|NCT03803202|143344939|OTHER||Ratio of GMC|1.4|||||TWO_SIDED|95.0|0.8|2.44|||t-test, 2 sided|||Serotype 6A, Day 1||2.44|0.80|
71912335|NCT03803202|143344939|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.69|1.99|||t-test, 2 sided|||Serotype 6B, Day 1||1.99|0.69|
71912336|NCT03803202|143344939|OTHER||Ratio of GMC|2.09|||||TWO_SIDED|95.0|1.19|3.67|||t-test, 2 sided|||Serotype 6B, Day 1||3.67|1.19|
71912337|NCT03803202|143344939|OTHER||Ratio of GMC|1.59|||||TWO_SIDED|95.0|0.88|2.88|||t-test, 2 sided|||Serotype 6B, Day 1||2.88|0.88|
71912338|NCT03803202|143344939|OTHER||Ratio of GMC|1.01|||||TWO_SIDED|95.0|0.62|1.65|||t-test, 2 sided|||Serotype 7F, Day 1||1.65|0.62|
71912339|NCT03803202|143344939|OTHER||Ratio of GMC|1.58|||||TWO_SIDED|95.0|0.94|2.67|||t-test, 2 sided|||Serotype 7F, Day 1||2.67|0.94|
71912340|NCT03803202|143344939|OTHER||Ratio of GMC|0.9|||||TWO_SIDED|95.0|0.5|1.64|||t-test, 2 sided|||Serotype 7F, Day 1||1.64|0.50|
71912341|NCT03803202|143344939|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.52|1.21|||t-test, 2 sided|||Serotype 9V, Day 1||1.21|0.52|
71912342|NCT03803202|143344939|OTHER||Ratio of GMC|1.57|||||TWO_SIDED|95.0|0.97|2.54|||t-test, 2 sided|||Serotype 9V, Day 1||2.54|0.97|
71912343|NCT03803202|143344939|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.6|1.6|||t-test, 2 sided|||Serotype 9V, Day 1||1.60|0.60|
71912344|NCT03803202|143344939|OTHER||Ratio of GMC|0.73|||||TWO_SIDED|95.0|0.4|1.33|||t-test, 2 sided|||Serotype 14, Day 1||1.33|0.40|
71912345|NCT03803202|143344939|OTHER||Ratio of GMC|1.33|||||TWO_SIDED|95.0|0.73|2.44|||t-test, 2 sided|||Serotype 14, Day 1||2.44|0.73|
71912346|NCT03803202|143344939|OTHER||Ratio of GMC|0.87|||||TWO_SIDED|95.0|0.46|1.63|||t-test, 2 sided|||Serotype 14, Day 1||1.63|0.46|
71912347|NCT03803202|143344939|OTHER||Ratio of GMC|0.69|||||TWO_SIDED|95.0|0.42|1.12|||t-test, 2 sided|||Serotype 18C, Day 1||1.12|0.42|
71912348|NCT03803202|143344939|OTHER||Ratio of GMC|1.53|||||TWO_SIDED|95.0|0.92|2.55|||t-test, 2 sided|||Serotype 18C, Day 1||2.55|0.92|
71912349|NCT03803202|143344939|OTHER||Ratio of GMC|0.78|||||TWO_SIDED|95.0|0.44|1.37|||t-test, 2 sided|||Serotype 18C, Day 1||1.37|0.44|
71912350|NCT03803202|143344939|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.54|1.25|||t-test, 2 sided|||Serotype 19A, Day 1||1.25|0.54|
71912351|NCT03803202|143344939|OTHER||Ratio of GMC|1.34|||||TWO_SIDED|95.0|0.84|2.12|||t-test, 2 sided|||Serotype 19A, Day 1||2.12|0.84|
71912352|NCT03803202|143344939|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.66|||t-test, 2 sided|||Serotype 19A, Day 1||1.66|0.66|
71912353|NCT03803202|143344939|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.37|||t-test, 2 sided|||Serotype 19F, Day 1||1.37|0.51|
71912354|NCT03803202|143344939|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.75|2.11|||t-test, 2 sided|||Serotype 19F, Day 1||2.11|0.75|
71912355|NCT03803202|143344939|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.57|1.72|||t-test, 2 sided|||Serotype 19F, Day 1||1.72|0.57|
71912356|NCT03803202|143344939|OTHER||Ratio of GMC|1.08|||||TWO_SIDED|95.0|0.63|1.86|||t-test, 2 sided|||Serotype 23F, Day 1||1.86|0.63|
71912357|NCT03803202|143344939|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.69|2.08|||t-test, 2 sided|||Serotype 23F, Day 1||2.08|0.69|
71912358|NCT03803202|143344939|OTHER||Ratio of GMC|1.19|||||TWO_SIDED|95.0|0.67|2.14|||t-test, 2 sided|||Serotype 23F, Day 1||2.14|0.67|
71912359|NCT03803202|143344939|OTHER||Ratio of GMC|0.82|||||TWO_SIDED|95.0|0.52|1.29|||t-test, 2 sided|||Serotype 1, Day 30||1.29|0.52|
71912360|NCT03803202|143344939|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.68|1.59|||t-test, 2 sided|||Serotype 1, Day 30||1.59|0.68|
71912361|NCT03803202|143344939|OTHER||Ratio of GMC|1.17|||||TWO_SIDED|95.0|0.76|1.8|||t-test, 2 sided|||Serotype 1, Day 30||1.80|0.76|
71912362|NCT03803202|143344939|OTHER||Ratio of GMC|2.07|||||TWO_SIDED|95.0|1.42|3.01|||t-test, 2 sided|||Serotype 3, Day 30||3.01|1.42|
71912363|NCT03803202|143344939|OTHER||Ratio of GMC|3.29|||||TWO_SIDED|95.0|2.37|4.58|||t-test, 2 sided|||Serotype 3, Day 30||4.58|2.37|
71912364|NCT03803202|143344939|OTHER||Ratio of GMC|4.05|||||TWO_SIDED|95.0|2.83|5.79|||t-test, 2 sided|||Serotype 3, Day 30||5.79|2.83|
71912365|NCT03803202|143344939|OTHER||Ratio of GMC|0.79|||||TWO_SIDED|95.0|0.49|1.27|||t-test, 2 sided|||Serotype 4, Day 30||1.27|0.49|
71912366|NCT03803202|143344939|OTHER||Ratio of GMC|0.97|||||TWO_SIDED|95.0|0.63|1.48|||t-test, 2 sided|||Serotype 4, Day 30||1.48|0.63|
71682870|NCT05153148|142883831|SUPERIORITY||Treatment Difference|-1.0|||=|0.196|TWO_SIDED|95.0|-2.6|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-2.6|=0.196
71682871|NCT05153148|142883832|SUPERIORITY||Treatment Difference|-1.9|||=|0.637|TWO_SIDED|95.0|-9.6|5.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|5.9|-9.6|=0.637
71912367|NCT03803202|143344939|OTHER||Ratio of GMC|1.05|||||TWO_SIDED|95.0|0.66|1.65|||t-test, 2 sided|||Serotype 4, Day 30||1.65|0.66|
71912368|NCT03803202|143344939|OTHER||Ratio of GMC|1.31|||||TWO_SIDED|95.0|0.75|2.29|||t-test, 2 sided|||Serotype 5, Day 30||2.29|0.75|
71912369|NCT03803202|143344939|OTHER||Ratio of GMC|1.3|||||TWO_SIDED|95.0|0.77|2.19|||t-test, 2 sided|||Serotype 5, Day 30||2.19|0.77|
71912370|NCT03803202|143344939|OTHER||Ratio of GMC|1.91|||||TWO_SIDED|95.0|1.08|3.37|||t-test, 2 sided|||Serotype 5, Day 30||3.37|1.08|
71912371|NCT03803202|143344939|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.49|||t-test, 2 sided|||Serotype 6A, Day 30||1.49|0.50|
71912372|NCT03803202|143344939|OTHER||Ratio of GMC|1.06|||||TWO_SIDED|95.0|0.65|1.72|||t-test, 2 sided|||Serotype 6A, Day 30||1.72|0.65|
71912373|NCT03803202|143344939|OTHER||Ratio of GMC|1.22|||||TWO_SIDED|95.0|0.71|2.1|||t-test, 2 sided|||Serotype 6A, Day 30||2.10|0.71|
71912374|NCT03803202|143344939|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.56|1.75|||t-test, 2 sided|||Serotype 6B, Day 30||1.75|0.56|
71912375|NCT03803202|143344939|OTHER||Ratio of GMC|1.44|||||TWO_SIDED|95.0|0.84|2.47|||t-test, 2 sided|||Serotype 6B, Day 30||2.47|0.84|
71912376|NCT03803202|143344939|OTHER||Ratio of GMC|1.77|||||TWO_SIDED|95.0|1.0|3.15|||t-test, 2 sided|||Serotype 6B, Day 30||3.15|1.00|
71912377|NCT03803202|143344939|OTHER||Ratio of GMC|1.54|||||TWO_SIDED|95.0|1.02|2.3|||t-test, 2 sided|||Serotype 7F, Day 30||2.30|1.02|
71912378|NCT03803202|143344939|OTHER||Ratio of GMC|1.55|||||TWO_SIDED|95.0|1.06|2.26|||t-test, 2 sided|||Serotype 7F, Day 30||2.26|1.06|
71912379|NCT03803202|143344939|OTHER||Ratio of GMC|1.66|||||TWO_SIDED|95.0|1.09|2.53|||t-test, 2 sided|||Serotype 7F, Day 30||2.53|1.09|
71912380|NCT03803202|143344939|OTHER||Ratio of GMC|1.29|||||TWO_SIDED|95.0|0.81|2.07|||t-test, 2 sided|||Serotype 9V, Day 30||2.07|0.81|
71912381|NCT03803202|143344939|OTHER||Ratio of GMC|1.64|||||TWO_SIDED|95.0|1.04|2.57|||t-test, 2 sided|||Serotype 9V, Day 30||2.57|1.04|
71912382|NCT03803202|143344939|OTHER||Ratio of GMC|2.16|||||TWO_SIDED|95.0|1.35|3.47|||t-test, 2 sided|||Serotype 9V, Day 30||3.47|1.35|
71912383|NCT03803202|143344939|OTHER||Ratio of GMC|0.99|||||TWO_SIDED|95.0|0.58|1.68|||t-test, 2 sided|||Serotype 14, Day 30||1.68|0.58|
71912384|NCT03803202|143344939|OTHER||Ratio of GMC|1.26|||||TWO_SIDED|95.0|0.77|2.05|||t-test, 2 sided|||Serotype 14, Day 30||2.05|0.77|
71912385|NCT03803202|143344939|OTHER||Ratio of GMC|1.67|||||TWO_SIDED|95.0|0.99|2.81|||t-test, 2 sided|||Serotype 14, Day 30||2.81|0.99|
71912386|NCT03803202|143344939|OTHER||Ratio of GMC|0.61|||||TWO_SIDED|95.0|0.39|0.95|||t-test, 2 sided|||Serotype 18C, Day 30||0.95|0.39|
71912387|NCT03803202|143344939|OTHER||Ratio of GMC|1.04|||||TWO_SIDED|95.0|0.7|1.54|||t-test, 2 sided|||Serotype 18C, Day 30||1.54|0.70|
71912388|NCT03803202|143344939|OTHER||Ratio of GMC|1.03|||||TWO_SIDED|95.0|0.67|1.57|||t-test, 2 sided|||Serotype 18C, Day 30||1.57|0.67|
71912389|NCT03803202|143344939|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.56|1.25|||t-test, 2 sided|||Serotype 19A, Day 30||1.25|0.56|
71912390|NCT03803202|143344939|OTHER||Ratio of GMC|1.07|||||TWO_SIDED|95.0|0.75|1.52|||t-test, 2 sided|||Serotype 19A, Day 30||1.52|0.75|
71912391|NCT03803202|143344939|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.77|1.86|||t-test, 2 sided|||Serotype 19A, Day 30||1.86|0.77|
71912392|NCT03803202|143344939|OTHER||Ratio of GMC|1.2|||||TWO_SIDED|95.0|0.76|1.9|||t-test, 2 sided|||Serotype 19F, Day 30||1.90|0.76|
71912393|NCT03803202|143344939|OTHER||Ratio of GMC|1.69|||||TWO_SIDED|95.0|1.11|2.58|||t-test, 2 sided|||Serotype 19F, Day 30||2.58|1.11|
71912394|NCT03803202|143344939|OTHER||Ratio of GMC|2.23|||||TWO_SIDED|95.0|1.41|3.52|||t-test, 2 sided|||Serotype 19F, Day 30||3.52|1.41|
71912395|NCT03803202|143344939|OTHER||Ratio of GMC|0.86|||||TWO_SIDED|95.0|0.5|1.47|||t-test, 2 sided|||Serotype 23F, Day 30||1.47|0.50|
71912396|NCT03803202|143344939|OTHER||Ratio of GMC|0.83|||||TWO_SIDED|95.0|0.51|1.35|||t-test, 2 sided|||Serotype 23F, Day 30||1.35|0.51|
71912397|NCT03803202|143344939|OTHER||Ratio of GMC|1.18|||||TWO_SIDED|95.0|0.69|2.02|||t-test, 2 sided|||Serotype 23F, Day 30||2.02|0.69|
71912398|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.4|0.805
71912399|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.102|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.102
71912400|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.158|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 1, Day 30||0.9|-0.1|0.158
71912401|NCT03803202|143344942|OTHER||Mean Difference|-0.1||||0.596|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Serotype 2, Day 30||0.2|-0.4|0.596
71912402|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.025|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.025
71912403|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.005|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.1|0.005
71912404|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.037|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 3, Day 30||0.7|0.0|0.037
71912405|NCT03803202|143344942|OTHER||Mean Difference|0.6||||0.002|TWO_SIDED|95.0|0.2|0.9|||ANCOVA|||Serotype 3, Day 30||0.9|0.2|0.002
71912406|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.23|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.230
71912407|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 4, Day 30||0.4|-0.4|0.984
71912408|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.262
71912409|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.264|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.264
71912410|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.638|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 5, Day 30||0.6|-0.4|0.638
71682872|NCT05153148|142883832|SUPERIORITY||Treatment Difference|-9.2|||=|0.021|TWO_SIDED|95.0|-17.0|-1.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.4|-17.0|=0.021
71867792|NCT00620282|143252843|SUPERIORITY_OR_OTHER||Least squares mean|-0.42||||0.2282||95.0|-1.118|0.278||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.278|-1.118|0.2282
71867793|NCT00620282|143252843|SUPERIORITY_OR_OTHER||Least squares mean|-0.018||||0.9569||95.0|-0.697|0.661||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.661|-0.697|0.9569
71867794|NCT00620282|143252843|SUPERIORITY_OR_OTHER||Least squares mean|-0.402||||0.2465||95.0|-1.097|0.293||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.||0.293|-1.097|0.2465
71867795|NCT00548262|143252861|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Success at EOT||73.6|44.6|
71867796|NCT00548262|143252862|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|EIVT Success||73.6|44.6|
71867797|NCT00548262|143252862|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Week 2 Follow-up Success||62.5|33.0|
71912411|NCT03803202|143344942|OTHER||Mean Difference|0.5||||0.036|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 5, Day 30||1.0|0.0|0.036
71867798|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
71912412|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.094|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.094
71867799|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|0.0|100.0|||||95% CI based on normal approximation to the binomial.|Candida famata: Success||100.0|0.0|
71867800|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
71867801|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
71867802|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
71912413|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.266|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.266
71867803|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
71912414|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.25|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 6A, Day 30||0.8|-0.2|0.250
71867804|NCT00548262|143252863|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
71867805|NCT00548262|143252864|SUPERIORITY_OR_OTHER||percentage of participants with success|52.4|||||TWO_SIDED|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||73.7|31.0|
71867806|NCT00548262|143252864|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success||100.0|13.3|
71867807|NCT00548262|143252864|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
71867808|NCT00548262|143252864|SUPERIORITY_OR_OTHER||percentage of participants with success|16.7|||||TWO_SIDED|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success||46.5|0.0|
71867809|NCT00548262|143252864|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||100.0|55.2|
71867810|NCT00548262|143252864|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||93.8|20.5|
71867811|NCT00548262|143252865|SUPERIORITY_OR_OTHER||percentage of participants with success|47.6|||||TWO_SIDED|95.0|26.3|69.0|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success||69.0|26.3|
71867812|NCT00548262|143252865|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success||100.0|13.3|
71912415|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.927|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Serotype 6A, Day 30||0.5|-0.5|0.927
71912416|NCT03803202|143344942|OTHER||Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.5|0.679
71912417|NCT03803202|143344942|OTHER||Mean Difference|-0.1||||0.589|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 6B, Day 30||0.3|-0.6|0.589
71912418|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.88|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 6B, Day 30||0.4|-0.5|0.880
71912419|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.623|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.2|0.623
71912420|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.232|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 7F, Day 30||0.6|-0.1|0.232
71912421|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.451|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.2|0.451
71912422|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.785|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.785
71682873|NCT05153148|142883832|SUPERIORITY||Treatment Difference|-8.7|||=|0.03|TWO_SIDED|95.0|-16.5|-0.9|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-0.9|-16.5|=0.030
71682874|NCT05153148|142883833|SUPERIORITY||Treatment Difference|-0.9|||=|0.812|TWO_SIDED|95.0|-8.4|6.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|6.6|-8.4|=0.812
71912423|NCT03803202|143344942|OTHER||Mean Difference|0.8|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
71912424|NCT03803202|143344942|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.4|1.1|||ANCOVA|||Serotype 8, Day 30||1.1|0.4|<.001
71912425|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.146|TWO_SIDED|95.0|-0.1|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.1|0.146
71912426|NCT03803202|143344942|OTHER||Mean Difference|0.5||||0.003|TWO_SIDED|95.0|0.2|0.8|||ANCOVA|||Serotype 9N, Day 30||0.8|0.2|0.003
71912427|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.113|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9N, Day 30||0.6|-0.1|0.113
71912428|NCT03803202|143344942|OTHER||Mean Difference|-0.2||||0.453|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 9V, Day 30||0.3|-0.6|0.453
71912429|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 9V, Day 30||0.8|-0.1|0.111
71912430|NCT03803202|143344942|OTHER||Mean Difference|0.5||||0.02|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 9V, Day 30||1.0|0.1|0.020
71912431|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.218|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.218
71912432|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.125|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 10A, Day 30||0.9|-0.1|0.125
71912433|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.706|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.4|0.706
71912434|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.246|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 11A, Day 30||0.6|-0.1|0.246
71912435|NCT03803202|143344942|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.1|||ANCOVA|||Serotype 11A, Day 30||1.1|0.3|<.001
71912436|NCT03803202|143344942|OTHER||Mean Difference|0.5||||0.01|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 11A, Day 30||0.9|0.1|0.010
71912437|NCT03803202|143344942|OTHER||Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Serotype 12F, Day 30||0.2|-0.7|0.260
71912438|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.366|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.3|0.366
71912439|NCT03803202|143344942|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 12F, Day 30||1.0|0.0|0.046
71912440|NCT03803202|143344942|OTHER||Mean Difference|-0.4||||0.101|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||Serotype 14, Day 30||0.1|-0.8|0.101
71912441|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.522||95.0|-0.3|0.6|||ANCOVA|||Serotype 14, Day 30||0.6|-0.3|0.522
71912442|NCT03803202|143344942|OTHER||Mean Difference|0.5||||0.026|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.1|0.026
71912443|NCT03803202|143344942|OTHER||Mean Difference|-0.2||||0.236|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Serotype 15B, Day 30||0.2|-0.6|0.236
71912444|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.528|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 15B, Day 30||0.5|-0.3|0.528
71912445|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.081|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 15B, Day 30||0.8|0.0|0.081
71912446|NCT03803202|143344942|OTHER||Mean Difference|-0.1||||0.388|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Serotype 17F, Day 30||0.2|-0.5|0.388
71912447|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.151|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.151
71912448|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.024|TWO_SIDED|95.0|0.1|0.7|||ANCOVA|||Serotype 17F, Day 30||0.7|0.1|0.024
71912449|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.476|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 18C, Day 30||0.5|-0.3|0.476
71912450|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.077|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 18C, Day 30||0.8|0.0|0.077
71912451|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.262|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 18C, Day 30||0.6|-0.2|0.262
71912452|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.767|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 19A, Day 30||0.4|-0.3|0.767
71912453|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.364
71912454|NCT03803202|143344942|OTHER||Mean Difference|0.1||||0.522|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.2|0.522
71912455|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.962|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 19F, Day 30||0.4|-0.4|0.962
71912456|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.091|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.091
71912457|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.093|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.1|0.093
71912458|NCT03803202|143344942|OTHER||Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Serotype 20B, Day 30||0.3|-0.6|0.455
71912459|NCT03803202|143344942|OTHER||Mean Difference|0.4||||0.093|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|-0.1|0.093
71912460|NCT03803202|143344942|OTHER||Mean Difference|0.6||||0.017|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Serotype 20B, Day 30||1.1|0.1|0.017
71912461|NCT03803202|143344942|OTHER||Mean Difference|-0.1||||0.561|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Serotype 22F, Day 30||0.3|-0.5|0.561
71912462|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.343|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 22F, Day 30||0.6|-0.2|0.343
71912463|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.132|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 22F, Day 30||0.7|-0.1|0.132
71912464|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 23F, Day 30||0.6|-0.5|0.898
71912465|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.313|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||Serotype 23F, Day 30||0.9|-0.3|0.313
71867813|NCT00548262|143252865|SUPERIORITY_OR_OTHER||percentage of participants with success|70.0|||||TWO_SIDED|95.0|41.6|98.4|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success||98.4|41.6|
71912466|NCT03803202|143344942|OTHER||Mean Difference|0.3||||0.366|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.3|0.366
71912467|NCT03803202|143344942|OTHER||Mean Difference|0.0||||0.961|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.961
71912468|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.269|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.269
71912469|NCT03803202|143344942|OTHER||Mean Difference|0.2||||0.245|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 33F, Day 30||0.6|-0.2|0.245
71912470|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.213|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 1, Day 30||0.7|-0.1|0.213
71912471|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.097|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 1, Day 30||0.8|-0.1|0.097
71912472|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.631|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 1, Day 30||0.5|-0.3|0.631
71912473|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 2, Day 30||0.4|-0.3|0.699
71912474|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.042|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|0.0|0.042
71912475|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.092|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 2, Day 30||0.7|-0.1|0.092
71912476|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.007|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 3, Day 30||0.8|0.1|0.007
71912477|NCT03803202|143344943|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 3, Day 30||1.0|0.3|<.001
71912478|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.237|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 3, Day 30||0.6|-0.1|0.237
71912479|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.248|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 4, Day 30||0.6|-0.2|0.248
71912480|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.193|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 4, Day 30||0.7|-0.1|0.193
71912481|NCT03803202|143344943|OTHER||Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Serotype 4, Day 30||0.5|-0.4|0.838
71912482|NCT03803202|143344943|OTHER||Mean Difference|0.0||||0.898|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 5, Day 30||0.4|-0.5|0.898
71912483|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.143|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.143
71912484|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.108|TWO_SIDED|95.0|-0.1|0.9|||ANCOVA|||Serotype 5, Day 30||0.9|-0.1|0.108
71912485|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.396|TWO_SIDED|95.0|-0.3|0.7|||ANCOVA|||Serotype 6A, Day 30||0.7|-0.3|0.396
71912486|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.182|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6A, Day 30||0.9|-0.2|0.182
71912487|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.593|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Serotype 6A, Day 30||0.6|-0.4|0.593
71912488|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Serotype 6B, Day 30||0.9|-0.2|0.186
71912489|NCT03803202|143344943|OTHER||Mean Difference|0.6||||0.038|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||Serotype 6B, Day 30||1.1|0.0|0.038
71912490|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.408|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Serotype 6B, Day 30||0.8|-0.3|0.408
71912491|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.805|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.3|0.805
71912492|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.711|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 7F, Day 30||0.5|-0.3|0.711
71912493|NCT03803202|143344943|OTHER||Mean Difference|0.0||||0.891|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 7F, Day 30||0.4|-0.4|0.891
71912494|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.649|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 8, Day 30||0.4|-0.3|0.649
71912495|NCT03803202|143344943|OTHER||Mean Difference|0.7|||<|0.001|TWO_SIDED|95.0|0.3|1.0|||ANCOVA|||Serotype 8, Day 30||1.0|0.3|<.001
71912496|NCT03803202|143344943|OTHER||Mean Difference|0.6|||<|0.001|TWO_SIDED|95.0|0.3|0.9|||ANCOVA|||Serotype 8, Day 30||0.9|0.3|<.001
71912497|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.454|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Serotype 9N, Day 30||0.5|-0.2|0.454
71912498|NCT03803202|143344943|OTHER||Mean Difference|0.6||||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 9N, Day 30||1.0|0.2|0.003
71912499|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.021|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9N, Day 30||0.9|0.1|0.021
71912500|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.205|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 9V, Day 30||0.6|-0.1|0.205
71912501|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.015|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 9V, Day 30||0.9|0.1|0.015
71912502|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.209|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 9V, Day 30||0.7|-0.1|0.209
71912503|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.502|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Serotype 10A, Day 30||0.6|-0.3|0.502
71912504|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.054|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 10A, Day 30||1.0|0.0|0.054
71912505|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 10A, Day 30||0.8|-0.2|0.190
71912506|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 11A, Day 30||0.4|-0.3|0.616
71912507|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.018|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 11A, Day 30||0.8|0.1|0.018
71912508|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.056|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Serotype 11A, Day 30||0.7|0.0|0.056
71912509|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.527|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Serotype 12F, Day 30||0.7|-0.4|0.527
71912510|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.444|TWO_SIDED|95.0|-0.4|0.8|||ANCOVA|||Serotype 12F, Day 30||0.8|-0.4|0.444
71912511|NCT03803202|143344943|OTHER||Mean Difference|0.0||||0.869|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Serotype 12F, Day 30||0.6|-0.5|0.869
71912512|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.305|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 14, Day 30||0.7|-0.2|0.305
71912513|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.046|TWO_SIDED|95.0|0.0|1.0|||ANCOVA|||Serotype 14, Day 30||1.0|0.0|0.046
71912514|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.299|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|||Serotype 14, Day 30||0.8|-0.2|0.299
71867814|NCT00548262|143252865|SUPERIORITY_OR_OTHER||percentage of participants with success|28.6|||||TWO_SIDED|95.0|0.0|62.0|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success||62.0|0.0|
71867815|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
71867816|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
71867817|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
71867818|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
71912515|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.14|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 15B, Day 30||0.7|-0.1|0.140
71912516|NCT03803202|143344943|OTHER||Mean Difference|0.9|||<|0.001|TWO_SIDED|95.0|0.4|1.3|||ANCOVA|||Serotype 15B, Day 30||1.3|0.4|<.001
71912517|NCT03803202|143344943|OTHER||Mean Difference|0.6||||0.012|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 15B, Day 30||1.0|0.1|0.012
71912518|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.2|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.1|0.200
71912519|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.037|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Serotype 17F, Day 30||0.8|0.0|0.037
71912520|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.38|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Serotype 17F, Day 30||0.6|-0.2|0.380
71912521|NCT03803202|143344943|OTHER||Mean Difference|0.6||||0.006|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.2|0.006
71912522|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.018|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Serotype 18C, Day 30||1.0|0.1|0.018
71912523|NCT03803202|143344943|OTHER||Mean Difference|-0.1||||0.81|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 18C, Day 30||0.4|-0.5|0.810
71912524|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.173|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Serotype 19A, Day 30||0.7|-0.1|0.173
71912525|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.096|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19A, Day 30||0.8|-0.1|0.096
71912526|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.71|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 19A, Day 30||0.5|-0.3|0.710
71912527|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.1|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 19F, Day 30||0.8|-0.1|0.100
71867819|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
71867820|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
71867821|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
71867822|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
71867823|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
71867824|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|67.7|||||TWO_SIDED|95.0|51.3|84.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||84.2|51.3|
71912528|NCT03803202|143344943|OTHER||Mean Difference|0.6||||0.007|TWO_SIDED|95.0|0.2|1.1|||ANCOVA|||Serotype 19F, Day 30||1.1|0.2|0.007
71912529|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.251|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 19F, Day 30||0.7|-0.2|0.251
71912530|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.618|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Serotype 20B, Day 30||0.5|-0.3|0.618
71912531|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.041|TWO_SIDED|95.0|0.0|0.9|||ANCOVA|||Serotype 20B, Day 30||0.9|0.0|0.041
71912532|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.111|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 20B, Day 30||0.8|-0.1|0.111
71912533|NCT03803202|143344943|OTHER||Mean Difference|0.1||||0.758|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Serotype 22F, Day 30||0.4|-0.3|0.758
71912534|NCT03803202|143344943|OTHER||Mean Difference|0.5||||0.012|TWO_SIDED|95.0|0.1|0.9|||ANCOVA|||Serotype 22F, Day 30||0.9|0.1|0.012
71912535|NCT03803202|143344943|OTHER||Mean Difference|0.4||||0.025|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Serotype 22F, Day 30||0.8|0.1|0.025
71912536|NCT03803202|143344943|OTHER||Mean Difference|0.0||||0.912|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Serotype 23F, Day 30||0.4|-0.5|0.912
71912537|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.174|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.174
71912538|NCT03803202|143344943|OTHER||Mean Difference|0.3||||0.138|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Serotype 23F, Day 30||0.8|-0.1|0.138
71912539|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.267|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.267
71912540|NCT03803202|143344943|OTHER||Mean Difference|0.2||||0.3|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Serotype 33F, Day 30||0.7|-0.2|0.300
71912541|NCT03803202|143344943|OTHER||Mean Difference|0.0||||0.982|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Serotype 33F, Day 30||0.4|-0.4|0.982
71912542|NCT03803202|143344944|OTHER||Ratio of GMT|1.49|||||TWO_SIDED|95.0|1.06|2.08|||t-test, 2 sided|||Serotype 2||2.08|1.06|
71912543|NCT03803202|143344944|OTHER||Ratio of GMT|0.97|||||TWO_SIDED|95.0|0.68|1.37|||t-test, 2 sided|||Serotype 8||1.37|0.68|
71912544|NCT03803202|143344944|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.92|2.0|||t-test, 2 sided|||Serotype 9N||2.00|0.92|
71867825|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
71867826|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
71867827|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|57.9|||||TWO_SIDED|95.0|35.7|80.1|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||80.1|35.7|
71867828|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|60.0|||||TWO_SIDED|95.0|40.8|79.2|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||79.2|40.8|
71867829|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
71867830|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
71867831|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
71867832|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
71867833|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|20.0|||||TWO_SIDED|95.0|0.0|55.1|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||55.1|0.0|
71867834|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|64.1|||||TWO_SIDED|95.0|49.0|79.2|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||79.2|49.0|
71867835|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|21.7|78.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||78.3|21.7|
71867836|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|62.5|||||TWO_SIDED|95.0|45.7|79.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||79.3|45.7|
71867837|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
71867838|NCT00548262|143252866|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
71867839|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|56.3|||||TWO_SIDED|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||73.4|39.1|
71867840|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||93.3|40.0|
71867841|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|54.5|||||TWO_SIDED|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||71.5|37.6|
71867842|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
71867843|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|56.4|||||TWO_SIDED|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||72.0|40.8|
71867844|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|80.0|||||TWO_SIDED|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||100.0|44.9|
71912545|NCT03803202|143344944|OTHER||Ratio of GMT|2.18|||||TWO_SIDED|95.0|1.25|3.79|||t-test, 2 sided|||Serotype 10A||3.79|1.25|
71912546|NCT03803202|143344944|OTHER||Ratio of GMT|1.19|||||TWO_SIDED|95.0|0.8|1.77|||t-test, 2 sided|||Serotype 11A||1.77|0.80|
71867845|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|55.3|||||TWO_SIDED|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||71.1|39.5|
71867846|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|83.3|||||TWO_SIDED|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||100.0|53.5|
71867847|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|46.2|||||TWO_SIDED|95.0|19.1|73.3|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||73.3|19.1|
71867848|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|64.5|||||TWO_SIDED|95.0|47.7|81.4|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||81.4|47.7|
71867849|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||79.5|6.2|
71867850|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||77.8|46.5|
71867851|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|63.2|||||TWO_SIDED|95.0|41.5|84.8|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||84.8|41.5|
71867852|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|56.0|||||TWO_SIDED|95.0|36.5|75.5|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||75.5|36.5|
71867853|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|59.1|||||TWO_SIDED|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||73.6|44.6|
71867854|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|42.9|||||TWO_SIDED|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||79.5|6.2|
71867855|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|62.2|||||TWO_SIDED|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||77.8|46.5|
71867856|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|58.1|||||TWO_SIDED|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||72.9|43.4|
71867857|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
71867858|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|61.5|||||TWO_SIDED|95.0|46.3|76.8|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||76.8|46.3|
71867859|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|58.3|||||TWO_SIDED|95.0|30.4|86.2|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||86.2|30.4|
71867860|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|59.4|||||TWO_SIDED|95.0|42.4|76.4|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||76.4|42.4|
71867861|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
71867862|NCT00548262|143252867|SUPERIORITY_OR_OTHER||percentage of participants with success|62.1|||||TWO_SIDED|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||79.7|44.4|
71912547|NCT03803202|143344944|OTHER||Ratio of GMT|1.2|||||TWO_SIDED|95.0|0.73|2.0|||t-test, 2 sided|||Serotype 12F||2.00|0.73|
71867863|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|37.5|||||TWO_SIDED|95.0|20.7|54.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success||54.3|20.7|
71867864|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|75.0|||||TWO_SIDED|95.0|50.5|99.5|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success||99.5|50.5|
71867865|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|39.4|||||TWO_SIDED|95.0|22.7|56.1|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success||56.1|22.7|
71867866|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|72.7|||||TWO_SIDED|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success||99.0|46.4|
71867867|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success||64.4|33.0|
71867868|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success||82.9|0.0|
71867869|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|47.4|||||TWO_SIDED|95.0|31.5|63.2|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success||63.2|31.5|
71867870|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|10.0|90.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success||90.0|10.0|
71867871|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|38.5|||||TWO_SIDED|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success||64.9|12.0|
71867872|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|51.6|||||TWO_SIDED|95.0|34.0|69.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success||69.2|34.0|
71912548|NCT03803202|143344944|OTHER||Ratio of GMT|1.47|||||TWO_SIDED|95.0|0.94|2.29|||t-test, 2 sided|||Serotype 15B||2.29|0.94|
71912549|NCT03803202|143344944|OTHER||Ratio of GMT|2.61|||||TWO_SIDED|95.0|1.68|4.04|||t-test, 2 sided|||Serotype 17F||4.04|1.68|
71912550|NCT03803202|143344944|OTHER||Ratio of GMT|9.05|||||TWO_SIDED|95.0|5.65|14.5|||t-test, 2 sided|||Serotype 20B||14.50|5.65|
71682875|NCT05153148|142883833|SUPERIORITY||Treatment Difference|-6.7|||=|0.079|TWO_SIDED|95.0|-14.2|0.8|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.8|-14.2|=0.079
71867873|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success||40.2|0.0|
71682876|NCT05153148|142883833|SUPERIORITY||Treatment Difference|-6.3|||=|0.102|TWO_SIDED|95.0|-13.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-13.9|=0.102
71867874|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success||70.1|38.0|
71867875|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|42.1|||||TWO_SIDED|95.0|19.9|64.3|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success||64.3|19.9|
71867876|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|52.0|||||TWO_SIDED|95.0|32.4|71.6|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success||71.6|32.4|
71867877|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|47.7|||||TWO_SIDED|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success||62.5|33.0|
71867878|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|14.3|||||TWO_SIDED|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success||40.2|0.0|
71867879|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|54.1|||||TWO_SIDED|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success||70.1|38.0|
71867880|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|46.5|||||TWO_SIDED|95.0|31.6|61.4|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success||61.4|31.6|
71867881|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|40.0|||||TWO_SIDED|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success||82.9|0.0|
71867882|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|48.7|||||TWO_SIDED|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success||64.4|33.0|
71867883|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|41.7|||||TWO_SIDED|95.0|13.8|69.6|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success||69.6|13.8|
71867884|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|50.0|||||TWO_SIDED|95.0|32.7|67.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success||67.3|32.7|
71867885|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|66.7|||||TWO_SIDED|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success||100.0|13.3|
71867886|NCT00548262|143252868|SUPERIORITY_OR_OTHER||percentage of participants with success|51.7|||||TWO_SIDED|95.0|33.5|69.9|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success||69.9|33.5|
71867887|NCT00548262|143252869|SUPERIORITY_OR_OTHER||percentage of participants with success|68.6|||||TWO_SIDED|95.0|53.2|84.0|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EIVT): Success||84.0|53.2|
71867888|NCT00548262|143252869|SUPERIORITY_OR_OTHER||percentage of participants with success|22.2|||||TWO_SIDED|95.0|0.0|49.4|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EIVT): Success||49.4|0.0|
71867889|NCT00548262|143252869|SUPERIORITY_OR_OTHER||percentage of participants with success|71.4|||||TWO_SIDED|95.0|56.5|86.4|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (EOT): Success||86.4|56.5|
71867890|NCT00548262|143252869|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EOT): Success||31.6|0.0|
71867891|NCT00548262|143252869|SUPERIORITY_OR_OTHER||percentage of participants with success|57.1|||||TWO_SIDED|95.0|40.7|73.5|||||95% CI based on normal approximation to the binomial.|APACHE \<20 (Week 2 F/U): Success||73.5|40.7|
71867892|NCT00548262|143252869|SUPERIORITY_OR_OTHER||percentage of participants with success|11.1|||||TWO_SIDED|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (Week 2 F/U): Success||31.6|0.0|
71867893|NCT02729831|143252904|SUPERIORITY||Mean Difference (Net)|9.0|||<|0.001|TWO_SIDED|95.0|6.0|12.0|||Regression, Linear|||The comparison groups were: Interactive decision versus Video decision aid.||12|6|<0.001
71867894|NCT02729831|143252905|SUPERIORITY||Odds Ratio (OR)|1.03||||0.86|TWO_SIDED|95.0|0.74|1.44|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.||1.44|0.74|0.86
71912551|NCT03803202|143344944|OTHER||Ratio of GMT|1.79|||||TWO_SIDED|95.0|1.09|2.95|||t-test, 2 sided|||Serotype 22F||2.95|1.09|
71912552|NCT03803202|143344944|OTHER|Serotype 33F|Ratio of GMT|1.34|||||TWO_SIDED|95.0|0.86|2.11|||t-test, 2 sided|||||2.11|0.86|
71912553|NCT03803202|143344944|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.93|1.83|||t-test, 2 sided|||Serotype 2||1.83|0.93|
71912554|NCT03803202|143344944|OTHER||Ratio of GMT|0.98|||||TWO_SIDED|95.0|0.67|1.43|||t-test, 2 sided|||Serotype 8||1.43|0.67|
71912555|NCT03803202|143344944|OTHER||Ratio of GMT|1.62|||||TWO_SIDED|95.0|1.62|2.26|||t-test, 2 sided|||Serotype 9N||2.26|1.62|
71912556|NCT03803202|143344944|OTHER||Ratio of GMT|2.87|||||TWO_SIDED|95.0|1.68|4.9|||t-test, 2 sided|||Serotype 10A||4.90|1.68|
71912557|NCT03803202|143344944|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.06|||t-test, 2 sided|||Serotype 11A||2.06|0.98|
71912558|NCT03803202|143344944|OTHER||Ratio of GMT|0.9|||||TWO_SIDED|95.0|0.54|1.48|||t-test, 2 sided|||Serotype 12F||1.48|0.54|
71912559|NCT03803202|143344944|OTHER||Ratio of GMT|1.09|||||TWO_SIDED|95.0|0.73|1.64|||t-test, 2 sided|||Serotype 15B||1.64|0.73|
71682877|NCT05153148|142883834|SUPERIORITY||Treatment Difference|-8.9|||=|0.016|TWO_SIDED|95.0|-16.2|-1.7|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.7|-16.2|=0.016
71682878|NCT05153148|142883834|SUPERIORITY||Treatment Difference|-10.6|||=|0.004|TWO_SIDED|95.0|-17.8|-3.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.4|-17.8|=0.004
71912560|NCT03803202|143344944|OTHER||Ratio of GMT|2.13|||||TWO_SIDED|95.0|1.4|3.25|||t-test, 2 sided|||Serotype 17F||3.25|1.40|
71912561|NCT03803202|143344944|OTHER||Ratio of GMT|7.28|||||TWO_SIDED|95.0|4.61|11.5|||t-test, 2 sided|||Serotype 20B||11.50|4.61|
71682879|NCT05153148|142883834|SUPERIORITY||Treatment Difference|-10.9|||=|0.003|TWO_SIDED|95.0|-18.2|-3.6|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-3.6|-18.2|=0.003
71867895|NCT02729831|143252905|SUPERIORITY||Odds Ratio (OR)|1.06||||0.75|TWO_SIDED|95.0|0.76|1.47|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid||1.47|0.76|0.75
71867896|NCT02729831|143252906|SUPERIORITY||Risk Difference (RD)|18.5|||<|0.001|TWO_SIDED|95.0|12.8|24.5|||Chi-squared|Compared patients who reported using all of the DA compared to everyone else.||Comparison groups were: patients who reported using all of the DA versus everyone else.||24.5|12.8|<0.001
71867897|NCT02729831|143252907|SUPERIORITY||Mean Difference (Net)|0.04|||<|0.001|TWO_SIDED|95.0|0.016|0.065|||Regression, Linear|Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint.||We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.||0.065|0.016|<0.001
71867898|NCT02729831|143252908|SUPERIORITY||Odds Ratio (OR)|25.7|||<|0.001|TWO_SIDED|95.0|16.5|40.1|||Regression, Logistic|General estimating equations were used to account for clustering of patients within surgeons.||We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.||40.1|16.5|<0.001
71867899|NCT01747551|143252909|SUPERIORITY|||||||0.72|||||||Log Rank|||||||0.72
71867900|NCT01142115|143252913|NON_INFERIORITY_OR_EQUIVALENCE|The estimated difference VAS(Monza) minus VAS(SpeediCath)(i.e. the upper confidence limit) shall be less than 1cm to demonstrate non-inferiority.|Mean Difference (Final Values)|1.052||||0.0018|TWO_SIDED|95.0|0.412|1.692|||Mixed Models Analysis|||||1.692|0.412|0.0018
71867901|NCT01142115|143252914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.805|||<|0.0001|TWO_SIDED|95.0|2.604|12.939|||Regression, Logistic|||||12.939|2.604|<0.0001
71867902|NCT01142115|143252915|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.616|TWO_SIDED|95.0|0.382|1.767|||Proportional odds regression model|||||1.767|0.382|0.6160
71867903|NCT01142115|143252916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.117||||0.8014|TWO_SIDED|95.0|0.472|2.646|||Proportional odds regression model|||||2.646|0.472|0.8014
71867904|NCT01142115|143252917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.503||||0.3085|TWO_SIDED|95.0|0.314|39.106|||Regression, Logistic|||||39.106|0.314|0.3085
71867905|NCT01142115|143252918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.398||||0.4324|TWO_SIDED|95.0|0.606|3.225|||Proportional odds regression model|||||3.225|0.606|0.4324
71867906|NCT04927247|143252929|OTHER||Difference in percentage|7.9||||0.6302|TWO_SIDED|95.0|-15.8|31.7|||Exact Cochran-Mantel-Haenszel test|||||31.7|-15.8|0.6302
71867907|NCT04927247|143252930|OTHER||Hazard Ratio (HR)|0.97||||0.9382|TWO_SIDED|95.0|0.43|2.16|||Stratified log-rank test|||||2.16|0.43|0.9382
71867908|NCT04927247|143252931|OTHER||Difference in percentage|-16.8||||0.1143|TWO_SIDED|95.0|-34.4|0.8|||Exact Cochran-Mantel-Haenszel test|||||0.8|-34.4|0.1143
71867909|NCT04927247|143252932|OTHER||Rate ratio|1.09||||0.7549|TWO_SIDED|95.0|0.63|1.89|||Negative binomial model|||||1.89|0.63|0.7549
71867910|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_DEVIATION|0.157||0.083||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glu/Cr posterior insula||||0.083
71867911|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.436||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr posterior insula||||0.436
71867912|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.306||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.306
71867913|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr posterior insula||||0.809
71867914|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.116|STANDARD_DEVIATION|0.177||0.016|||||||t-test, 2 sided|Significance was set at p \<0.05.|Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.016
71912562|NCT03803202|143344944|OTHER||Ratio of GMT|1.55|||||TWO_SIDED|95.0|0.96|2.48|||t-test, 2 sided|||Serotype 22F||2.48|0.96|
71912563|NCT03803202|143344944|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.83|1.84|||t-test, 2 sided|||Serotype 33F||1.84|0.83|
71912564|NCT03803202|143344944|OTHER||Ratio of GMT|2.1|||||TWO_SIDED|95.0|1.51|2.94|||t-test, 2 sided|||Serotype 2||2.94|1.51|
71867915|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.029|STANDARD_DEVIATION|0.308||0.708||||||Significance was set at p \<0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula||||0.708
71867916|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.809||95.0||||Significance was set at p \<0.050.|t-test, 2 sided|||Glu/Cr anterior insula||||0.809
71867917|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.154||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glu/Cr anterior insula||||0.154
71867918|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.960
71867919|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.937||95.0|||||t-test, 2 sided|Significance was set at p \<0.05.||Gln/Cr anterior insula||||0.937
71867920|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.897||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.897
71867921|NCT00760474|143252933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.309||95.0||||Significance was set at p \<0.05.|t-test, 2 sided|||Glx/Cr anterior insula||||0.309
71867922|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.032||||0.6347|TWO_SIDED|95.0|-0.1081|0.1714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Anterior Cingulate||0.1714|-0.1081|0.6347
71912565|NCT03803202|143344944|OTHER||Ratio of GMT|2.08|||||TWO_SIDED|95.0|1.46|2.97|||t-test, 2 sided|||Serotype 8||2.97|1.46|
71912566|NCT03803202|143344944|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.56|3.2|||t-test, 2 sided|||Serotype 9N||3.20|1.56|
71867923|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.079||||0.5181|TWO_SIDED|95.0|-0.3356|0.1771||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA22||0.1771|-0.3356|0.5181
71867924|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.072||||0.2987|TWO_SIDED|95.0|-0.2161|0.0714||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA40||0.0714|-0.2161|0.2987
71867925|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.029||||0.5151|TWO_SIDED|95.0|-0.064|0.1219||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_anIns||0.1219|-0.0640|0.5151
71867926|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.2369|TWO_SIDED|95.0|-0.2228|0.0599||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Amygdala||0.0599|-0.2228|0.2369
71867927|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.077||||0.0758|TWO_SIDED|95.0|-0.1642|0.0092||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Cerebellum||0.0092|-0.1642|0.0758
71867928|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.025||||0.4609|TWO_SIDED|95.0|-0.0947|0.0452||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_DLPFC||0.0452|-0.0947|0.4609
71867929|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.111||||0.3813|TWO_SIDED|95.0|-0.3745|0.1524||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Insula||0.1524|-0.3745|0.3813
71867930|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.02||||0.72|TWO_SIDED|95.0|-0.0964|0.1361||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Mid Temporal Pole||0.1361|-0.0964|0.7200
71912567|NCT03803202|143344944|OTHER||Ratio of GMT|3.24|||||TWO_SIDED|95.0|1.79|5.89|||t-test, 2 sided|||Serotype 10A||5.89|1.79|
71912568|NCT03803202|143344944|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.63|3.62|||t-test, 2 sided|||Serotype 11A||3.62|1.63|
71867931|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.168||||0.2099|TWO_SIDED|95.0|-0.1065|0.4434||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Orbito Front||0.4434|-0.1065|0.2099
71867932|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.003||||0.9551|TWO_SIDED|95.0|-0.1047|0.0992||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||PAG||0.0992|-0.1047|0.9551
71867933|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.994|TWO_SIDED|95.0|-0.0855|0.0848||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Posterior Insula||0.0848|-0.0855|0.9940
71912569|NCT03803202|143344944|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|0.89|2.55|||t-test, 2 sided|||Serotype 12 F||2.55|0.89|
71912570|NCT03803202|143344944|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 15B||2.57|1.11|
71912571|NCT03803202|143344944|OTHER||Ratio of GMT|3.37|||||TWO_SIDED|95.0|2.18|5.2|||t-test, 2 sided|||Serotype 17F||5.20|2.18|
71912572|NCT03803202|143344944|OTHER||Ratio of GMT|13.7|||||TWO_SIDED|95.0|8.26|22.72|||t-test, 2 sided|||Serotype 20B||22.72|8.26|
71912573|NCT03803202|143344944|OTHER||Ratio of GMT|2.17|||||TWO_SIDED|95.0|1.36|3.46|||t-test, 2 sided|||Serotype 22F||3.46|1.36|
71912574|NCT03803202|143344944|OTHER||Ratio of GMT|1.69|||||TWO_SIDED|95.0|1.11|2.57|||t-test, 2 sided|||Serotype 33F||2.57|1.11|
71682880|NCT05153148|142883835|SUPERIORITY||Treatment Difference|-0.07|||=|0.357|TWO_SIDED|95.0|-0.21|0.08|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.08|-0.21|=0.357
71682881|NCT05153148|142883835|SUPERIORITY||Treatment Difference|-0.1|||=|0.195|TWO_SIDED|95.0|-0.24|0.05|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.05|-0.24|=0.195
71867934|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.049||||0.4291|TWO_SIDED|95.0|-0.1792|0.0806||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Posterior Cingulate||0.0806|-0.1792|0.4291
71867935|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.027||||0.467|TWO_SIDED|95.0|-0.0496|0.1028||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Precuneus||0.1028|-0.0496|0.4670
71867936|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.044||||0.4443|TWO_SIDED|95.0|-0.0752|0.1624||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_Putamen||0.1624|-0.0752|0.4443
71867937|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.127||||0.2823|TWO_SIDED|95.0|-0.3704|0.1165||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_S2||0.1165|-0.3704|0.2823
71867938|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.105||||0.1369|TWO_SIDED|95.0|-0.2481|0.0378||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_DLPFC||0.0378|-0.2481|0.1369
71867939|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.078||||0.2376|TWO_SIDED|95.0|-0.0573|0.2127||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_anIns||0.2127|-0.0573|0.2376
71867940|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.153||||0.0968|TWO_SIDED|95.0|-0.3365|0.0313||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Amygdala||0.0313|-0.3365|0.0968
71912575|NCT03803202|143344945|OTHER||Ratio of GMT|1.35|||||TWO_SIDED|95.0|0.95|1.93|||t-test, 2 sided|||Serotype 2||1.93|0.95|
71912576|NCT03803202|143344945|OTHER||Ratio of GMT|1.51|||||TWO_SIDED|95.0|1.07|2.13|||t-test, 2 sided|||Serotype 8||2.13|1.07|
71912577|NCT03803202|143344945|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|1.09|2.33|||t-test, 2 sided|||Serotype 9N||2.33|1.09|
71912578|NCT03803202|143344945|OTHER||Ratio of GMT|2.24|||||TWO_SIDED|95.0|1.45|3.47|||t-test, 2 sided|||Serotype 10A||3.47|1.45|
71912579|NCT03803202|143344945|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.27|2.65|||t-test, 2 sided|||Serotype 11A||2.65|1.27|
71912580|NCT03803202|143344945|OTHER||Ratio of GMT|1.31|||||TWO_SIDED|95.0|0.77|2.23|||t-test, 2 sided|||Serotype 12F||2.23|0.77|
71912581|NCT03803202|143344945|OTHER||Ratio of GMT|1.24|||||TWO_SIDED|95.0|0.8|1.91|||t-test, 2 sided|||Serotype 15B||1.91|0.80|
71912582|NCT03803202|143344945|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.7|4.07|||t-test, 2 sided|||Serotype 17F||4.07|1.70|
71912583|NCT03803202|143344945|OTHER||Ratio of GMT|2.43|||||TWO_SIDED|95.0|1.61|3.67|||t-test, 2 sided|||Serotype 20B||3.67|1.61|
71912584|NCT03803202|143344945|OTHER||Ratio of GMT|2.49|||||TWO_SIDED|95.0|1.7|3.65|||t-test, 2 sided|||Serotype 22F||3.65|1.70|
71912585|NCT03803202|143344945|OTHER||Ratio of GMT|1.67|||||TWO_SIDED|95.0|1.1|2.54|||t-test, 2 sided|||Serotype 33F||2.54|1.10|
71912586|NCT03803202|143344945|OTHER||Ratio of GMT|1.42|||||TWO_SIDED|95.0|0.98|2.07|||t-test, 2 sided|||Serotype 2||2.07|0.98|
71912587|NCT03803202|143344945|OTHER||Ratio of GMT|1.58|||||TWO_SIDED|95.0|1.11|2.26|||t-test, 2 sided|||Serotype 8||2.26|1.11|
71912588|NCT03803202|143344945|OTHER||Ratio of GMT|1.83|||||TWO_SIDED|95.0|1.23|2.72|||t-test, 2 sided|||Serotype 9N||2.72|1.23|
71912589|NCT03803202|143344945|OTHER||Ratio of GMT|2.59|||||TWO_SIDED|95.0|1.66|4.05||||||Serotype 10A||4.05|1.66|
71912590|NCT03803202|143344945|OTHER||Ratio of GMT|1.9|||||TWO_SIDED|95.0|1.32|2.73|||t-test, 2 sided|||Serotype 11A||2.73|1.32|
71912591|NCT03803202|143344945|OTHER||Ratio of GMT|1.59|||||TWO_SIDED|95.0|0.93|2.71|||t-test, 2 sided|||Serotype 12F||2.71|0.93|
71912592|NCT03803202|143344945|OTHER||Ratio of GMT|1.68|||||TWO_SIDED|95.0|1.11|2.53|||t-test, 2 sided|||Serotype 15B||2.53|1.11|
71912593|NCT03803202|143344945|OTHER||Ratio of GMT|3.27|||||TWO_SIDED|95.0|2.17|4.93|||t-test, 2 sided|||Serotype 17F||4.93|2.17|
71912594|NCT03803202|143344945|OTHER||Ratio of GMT|2.79|||||TWO_SIDED|95.0|1.85|4.22|||t-test, 2 sided|||Serotype 20B||4.22|1.85|
71912595|NCT03803202|143344945|OTHER||Ratio of GMT|2.63|||||TWO_SIDED|95.0|1.79|3.88|||t-test, 2 sided|||Serotype 22F||3.88|1.79|
71912596|NCT03803202|143344945|OTHER||Ratio of GMT|2.05|||||TWO_SIDED|95.0|1.4|3.01|||t-test, 2 sided|||Serotype 33F||3.01|1.40|
71912597|NCT03803202|143344945|OTHER||Ratio of GMT|1.97|||||TWO_SIDED|95.0|1.37|2.84|||t-test, 2 sided|||Serotype 2||2.84|1.37|
71912598|NCT03803202|143344945|OTHER||Ratio of GMT|2.98|||||TWO_SIDED|95.0|2.12|4.18|||t-test, 2 sided|||Serotype 8||4.18|2.12|
71912599|NCT03803202|143344945|OTHER||Ratio of GMT|2.99|||||TWO_SIDED|95.0|2.02|4.44|||t-test, 2 sided|||Serotype 9N||4.44|2.02|
71912600|NCT03803202|143344945|OTHER||Ratio of GMT|3.63|||||TWO_SIDED|95.0|2.25|5.86|||t-test, 2 sided|||Serotype 10A||5.86|2.25|
71912601|NCT03803202|143344945|OTHER||Ratio of GMT|2.86|||||TWO_SIDED|95.0|1.96|4.18|||t-test, 2 sided|||Serotype 11A||4.18|1.96|
71912602|NCT03803202|143344945|OTHER||Ratio of GMT|1.64|||||TWO_SIDED|95.0|0.91|2.96|||t-test, 2 sided|||Serotype 12F||2.96|0.91|
71912603|NCT03803202|143344945|OTHER||Ratio of GMT|2.93|||||TWO_SIDED|95.0|1.87|4.61|||t-test, 2 sided|||Serotype 15B||4.61|1.87|
71867941|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.023||||0.572|TWO_SIDED|95.0|-0.061|0.1062||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_BA23\_base||0.1062|-0.0610|0.5720
71867942|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.027||||0.5822|TWO_SIDED|95.0|-0.1303|0.0761||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_IPL\_base||0.0761|-0.1303|0.5822
71912604|NCT03803202|143344945|OTHER||Ratio of GMT|4.0|||||TWO_SIDED|95.0|2.55|6.26|||t-test, 2 sided|||Serotype 17F||6.26|2.55|
71867943|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.044||||0.6851|TWO_SIDED|95.0|-0.2697|0.1824||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Insula\_base||0.1824|-0.2697|0.6851
71867944|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.013||||0.8656|TWO_SIDED|95.0|-0.1699|0.1446||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Insula||0.1446|-0.1699|0.8656
71867945|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.094||||0.1562|TWO_SIDED|95.0|-0.2296|0.0407||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Front\_DLPFC||0.0407|-0.2296|0.1562
71867946|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.012||||0.7752|TWO_SIDED|95.0|-0.0991|0.0754||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Mid Temporal Pole||0.0754|-0.0991|0.7752
71867947|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.01||||0.9182|TWO_SIDED|95.0|-0.1912|0.2109||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Orbito Front||0.2109|-0.1912|0.9182
71867948|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.022||||0.6544|TWO_SIDED|95.0|-0.0829|0.1278||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L\_PAG||0.1278|-0.0829|0.6544
71867949|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.087||||0.0813|TWO_SIDED|95.0|-0.0123|0.1863||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.1863|-0.0123|0.0813
71867950|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.052||||0.4605|TWO_SIDED|95.0|-0.0956|0.2004||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_pIns||0.2004|-0.0956|0.4605
71867951|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.081||||0.3136|TWO_SIDED|95.0|-0.2484|0.0856||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Posterior Cingulate||0.0856|-0.2484|0.3136
71867952|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9929|TWO_SIDED|95.0|-0.0885|0.0893||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus||0.0893|-0.0885|0.9929
71867953|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.002||||0.949|TWO_SIDED|95.0|-0.0815|0.0767||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Precuneus\_base||0.0767|-0.0815|0.9490
71867954|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.065||||0.5668|TWO_SIDED|95.0|-0.3019|0.1722||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Superior Temporal||0.1722|-0.3019|0.5668
71867955|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.0||||0.9958|TWO_SIDED|95.0|-0.1398|0.1391||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Premotor||0.1391|-0.1398|0.9958
71867956|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.057||||0.3379|TWO_SIDED|95.0|-0.0659|0.1795||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Putamen||0.1795|-0.0659|0.3379
71867957|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.085||||0.2186|TWO_SIDED|95.0|-0.2262|0.0565||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_S1||0.0565|-0.2262|0.2186
71912605|NCT03803202|143344945|OTHER||Ratio of GMT|3.82|||||TWO_SIDED|95.0|2.46|5.91|||t-test, 2 sided|||Serotype 22F||5.91|2.46|
71912606|NCT03803202|143344945|OTHER||Ratio of GMT|4.02|||||TWO_SIDED|95.0|2.74|5.9|||t-test, 2 sided|||Serotype 22F||5.90|2.74|
71912607|NCT03803202|143344945|OTHER||Ratio of GMT|2.11|||||TWO_SIDED|95.0|1.38|3.23|||t-test, 2 sided|||Serotype 33F||3.23|1.38|
71682882|NCT05153148|142883835|SUPERIORITY||Treatment Difference|-0.05|||=|0.467|TWO_SIDED|95.0|-0.2|0.09|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.09|-0.20|=0.467
71682883|NCT05153148|142883836|SUPERIORITY||Treatment Difference|1.3|||=|0.031|TWO_SIDED|95.0|0.1|2.4|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|2.4|0.1|=0.031
71682884|NCT05153148|142883836|SUPERIORITY||Treatment Difference|0.1|||=|0.86|TWO_SIDED|95.0|-1.1|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-1.1|=0.860
71682885|NCT05153148|142883836|SUPERIORITY||Treatment Difference|0.2|||=|0.758|TWO_SIDED|95.0|-0.9|1.3|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.3|-0.9|=0.758
71867958|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|-0.008||||0.8191|TWO_SIDED|95.0|-0.0843|0.0678||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R\_Thalamus||0.0678|-0.0843|0.8191
71867959|NCT00760474|143252934|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean difference|0.012||||0.7647|TWO_SIDED|95.0|-0.0698|0.093||Significance was set at p \<0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Precuneus||0.0930|-0.0698|0.7647
71867960|NCT04664400|143252950|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.043|||||||t-test, 1 sided|||||||0.043
71867961|NCT04664400|143252951|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.036|||||||t-test, 1 sided|||||||0.036
71867962|NCT04664400|143252952|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.012|||||||t-test, 1 sided|||||||0.012
71867963|NCT04664400|143252953|OTHER|Paired t test, testing whether the within participant difference is larger than 0.||||||0.835|||||||t-test, 1 sided|||||||0.835
71867964|NCT01011153|143252961|NON_INFERIORITY_OR_EQUIVALENCE|Sample sizes computed based on data from smaller studies provided 90% power for the comparison of sensitivity. Under the alternative hypothesis that the biopsy sensitivity of MelaFind would be 0.10 greater than the average biopsy/referral sensitivity of physicians (combined or separate), the probability that a 95% CI lies entirely above zero will be at least 90% when the standard error of the estimated difference is at most 0.0308.|Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.18|0.32|||ANOVA|||Using True Positives/All Positives, sensitivity values were calculated for MelaFind as well as the average of the 110 dermatologists.||0.32|0.18|<0.0001
71867965|NCT01011153|143252962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.19|0.34|||ANOVA|||Sensitivity||0.34|0.19|<0.0001
71867966|NCT01011153|143252962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24|STANDARD_DEVIATION|0.04|<|0.0001|TWO_SIDED|95.0|0.16|0.31|||ANOVA|||Sensitivity||0.31|0.16|<0.0001
71867967|NCT01011153|143252962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_DEVIATION|0.03|<|0.0001|TWO_SIDED|95.0|0.19|0.33|||ANOVA|||Sensitivity||0.33|0.19|<0.0001
71867968|NCT01011153|143252962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.46|-0.25|||ANOVA|||Specificity||-0.25|-0.46|<0.0001
71867969|NCT01011153|143252962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.31|||ANOVA|||Specificity||-0.31|-0.53|<0.0001
71867970|NCT01011153|143252962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_DEVIATION|0.05|<|0.0001|TWO_SIDED|95.0|-0.51|-0.3|||ANOVA|||Specificity||-0.30|-0.51|<0.0001
71867971|NCT01011153|143252963|SUPERIORITY_OR_OTHER||Kappa|0.313|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made.|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
71867972|NCT01011153|143252963|SUPERIORITY_OR_OTHER||Kappa|0.276|STANDARD_ERROR_OF_MEAN|0.002||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
71867973|NCT01011153|143252963|SUPERIORITY_OR_OTHER||Kappa|0.2|STANDARD_ERROR_OF_MEAN|0.003||||0.0||||No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
71867974|NCT01011153|143252963|SUPERIORITY_OR_OTHER||Kappa|0.256|STANDARD_ERROR_OF_MEAN|0.001||||0.0||||N/A - No comparison is being made|ANOVA||There is no threshold level-this is a measurement of variability among responses provided by the participants.|||||
71867975|NCT00383110|143252971|SUPERIORITY_OR_OTHER|||||||0.648|||||||ANOVA|||||||0.648
71867976|NCT00383110|143252972|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANOVA|||||||0.14
71867977|NCT00383110|143252973|SUPERIORITY_OR_OTHER|||||||0.675|||||||ANOVA|||||||0.675
71867978|NCT00383110|143252974|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
71867979|NCT00383110|143252975|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71867980|NCT00383110|143252976|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71867981|NCT00432666|143253014|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.97|STANDARD_ERROR_OF_MEAN|1.49|<|0.001|TWO_SIDED|95.0|1.9|8.3|||Regression, Logistic|||The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.||8.30|1.90|<0.001
71867982|NCT02980731|143253104|SUPERIORITY||||||=|0.004||||||P-value is derived from a paired t-test of H0: mean difference (Week 48 - baseline) ≤ 5 versus H1: mean difference (Week 48 - baseline) \> 5|t-test, 2 sided|||||||=0.004
71867983|NCT02516332|143253134|OTHER|||||||0.038|||||||ANCOVA|||||||0.038
71867984|NCT02516332|143253134|OTHER|||||||0.002|||||||ANCOVA|||||||0.002
71867985|NCT02516332|143253139|OTHER|||||||0.011|||||||Regression, Linear|||||||0.011
71867986|NCT02516332|143253139|OTHER|||||||0.036|||||||Regression, Linear|||||||0.036
71867987|NCT00605215|143253145|OTHER||Risk Ratio (RR)|0.823|STANDARD_ERROR_OF_MEAN|0.09||0.0746|TWO_SIDED|95.0|0.664|1.02||Threshold for significance at 0.05 level.|Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||1.020|0.664|0.0746
71867988|NCT00605215|143253145|OTHER||Risk Ratio (RR)|0.741|STANDARD_ERROR_OF_MEAN|0.082||0.0067|TWO_SIDED|95.0|0.596|0.92|||Negative Binomial Regression|||Analysis was performed using baseline-adjusted negative binomial regression, where a participant's number of relapses during the double-blind, placebo-controlled phase served as the response variable and an offset based on the log of participant's exposure in years was employed to adjust for variability of treatment exposure. The model included baseline EDSS score, log of (prior 2-year number of relapses+1) and CGR as covariates.||0.920|0.596|0.0067
71912608|NCT00293241|143344955|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.72|TWO_SIDED|95.0|0.612|1.405|||Log Rank||"Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition~CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism"|"Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600"||1.405|0.612|0.72
71912609|NCT00293241|143344956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.127||||0.48|TWO_SIDED|95.0|0.808|1.57|||Log Rank|||"Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization"||1.570|0.808|0.48
71912610|NCT00293241|143344957|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.521||||0.08|TWO_SIDED|95.0|0.954|2.424|||Log Rank|||Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF||2.424|0.954|0.08
71912611|NCT00293241|143344958|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.425||||0.44|TWO_SIDED|95.0|0.573|3.543|||Log Rank|||Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF||3.543|0.573|0.44
71912612|NCT00293241|143344959|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:"||||<0.0001
71912613|NCT00293241|143344960|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Regression, Linear|||||||0.048
71912614|NCT00293241|143344962|SUPERIORITY_OR_OTHER|||||||0.78|TWO_SIDED|95.0|||||Repeated measures logistic regression|||Analysis:Repeated measures logistic regression||||0.78
71912615|NCT00293241|143344963|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers||||0.34
71912616|NCT00293241|143344963|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin||||0.65
71912617|NCT00293241|143344963|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists||||0.55
71912618|NCT00293241|143344963|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug||||0.53
71912619|NCT00293241|143344965|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.243||||0.33|TWO_SIDED|95.0|0.803|1.923|||Log Rank|||"Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF"||1.923|0.803|0.33
71912620|NCT00293241|143344966|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.492||||0.24|TWO_SIDED|95.0|0.148|1.637|||Log Rank|||||1.637|0.148|0.24
71912621|NCT00293241|143344967|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Statistical test for Number of subjects with CV hospitalization||||0.83
71912622|NCT00293241|143344970|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval||||0.34
71682886|NCT05153148|142883837|SUPERIORITY||Treatment Difference|-0.5|||=|0.131|TWO_SIDED|95.0|-1.2|0.2|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.2|-1.2|=0.131
71912623|NCT00293241|143344970|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration||||0.19
71912624|NCT00293241|143344970|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration||||0.29
71912625|NCT00293241|143344971|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|95.0|||||Fisher Exact|||No Symptoms (Baseline)||||0.24
71912626|NCT00293241|143344971|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Fisher Exact|||No Symptoms (12 months)||||0.92
71912627|NCT00293241|143344971|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||No Symptoms (24 Months)||||1.0
71912628|NCT00293241|143344972|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.03
71912629|NCT01367860|143344976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|1.06||0.05|TWO_SIDED|95.0|-4.05|0.26|||t-test, 2 sided|||||0.26|-4.05|0.05
71912630|NCT01367860|143344977|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71912631|NCT01367860|143344978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.9|<|0.05|TWO_SIDED|95.0|-2.21|1.43|||t-test, 2 sided|||||1.43|-2.21|<0.05
71912632|NCT01367860|143344979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|1.01|<|0.05|TWO_SIDED|95.0|-2.76|1.33|||t-test, 2 sided|||||1.33|-2.76|<0.05
71912633|NCT01367860|143344981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.13|<|0.05|TWO_SIDED|95.0|-2.58|2.01|||t-test, 2 sided|||||2.01|-2.58|<0.05
71912634|NCT01367860|143344982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|1.14|<|0.05|TWO_SIDED|95.0|-1.3|3.3|||t-test, 2 sided|||||3.3|-1.3|<0.05
71912635|NCT01367860|143344983|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.77|<|0.05|TWO_SIDED|95.0|-2.36|8.8|||t-test, 2 sided|||||8.8|-2.36|<0.05
71912636|NCT01367860|143344984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|3.3|<|0.05|TWO_SIDED|95.0|-4.4|8.9|||t-test, 2 sided|||||8.9|-4.4|<0.05
71912637|NCT01367860|143344985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|3.6|<|0.05|TWO_SIDED|95.0|-7.15|7.55|||t-test, 2 sided|||||7.55|-7.15|<0.05
71912638|NCT01367860|143344986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|3.65|<|0.05|TWO_SIDED|95.0|-7.14|7.67|||t-test, 2 sided|||||7.67|-7.14|<0.05
71912639|NCT01367860|143344987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.18|<|0.05|TWO_SIDED|95.0|-8.16|4.76|||t-test, 2 sided|||||4.76|-8.16|<0.05
71912640|NCT01367860|143344988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.67|STANDARD_ERROR_OF_MEAN|0.88|<|0.05|TWO_SIDED|95.0|-0.12|3.46|||t-test, 2 sided|||||3.46|-0.12|<0.05
71912641|NCT01367860|143344989|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|1.09|<|0.05|TWO_SIDED|95.0|-2.0|2.4|||t-test, 2 sided|||||2.4|-2|<0.05
71912642|NCT01367860|143344990|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|1.08|<|0.05|TWO_SIDED|95.0|-2.55|1.85|||t-test, 2 sided|||||1.85|-2.55|<0.05
71867989|NCT02914275|143253154|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% confidence interval (CI) of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.79|||||TWO_SIDED|95.0|0.72|0.88||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||0.88|0.72|
71867990|NCT02914275|143253154|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.27|||||TWO_SIDED|95.0|1.15|1.42||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.42|1.15|
71867991|NCT02914275|143253154|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.12|||||TWO_SIDED|95.0|1.01|1.24||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.24|1.01|
71867992|NCT02914275|143253154|NON_INFERIORITY|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.97|||||TWO_SIDED|95.0|0.86|1.09||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination||1.09|0.86|
71867993|NCT02914275|143253155|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|-10.3|||||TWO_SIDED|95.0|-15.4|-5.1||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||-5.1|-15.4|
71867994|NCT02914275|143253155|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|2.6|||||TWO_SIDED|95.0|-2.54|7.8||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||7.8|-2.54|
71867995|NCT02914275|143253155|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|3.1|||||TWO_SIDED|95.0|-2.1|8.2||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||8.2|-2.1|
71867996|NCT02914275|143253155|NON_INFERIORITY|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|0.9|||||TWO_SIDED|95.0|-4.2|6.1||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination||6.1|-4.2|
71867997|NCT02704754|143253166|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71867998|NCT03809429|143253171|OTHER||Difference|1.31||||0.0185|TWO_SIDED|95.0|0.22|2.4|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.40|0.22|0.0185
71867999|NCT03809429|143253174|OTHER||Difference|1.14||||0.0281|TWO_SIDED|95.0|0.12|2.15|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=10 mm at end of stimulation||2.15|0.12|0.0281
71868000|NCT03809429|143253174|OTHER||Difference|0.99||||0.0258|TWO_SIDED|95.0|0.12|1.86|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=12 mm at end of stimulation||1.86|0.12|0.0258
71868001|NCT03809429|143253174|OTHER||Difference|0.58||||0.0672|TWO_SIDED|95.0|-0.04|1.2|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=15 mm at end of stimulation||1.20|-0.04|0.0672
71868002|NCT03809429|143253174|OTHER||Difference|0.21||||0.339|TWO_SIDED|95.0|-0.22|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||\>=17 mm at end of stimulation||0.63|-0.22|0.3390
71868003|NCT03809429|143253176|OTHER||Difference|1.11||||0.0962|TWO_SIDED|95.0|-0.2|2.41|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||||2.41|-0.20|0.0962
71868004|NCT03809429|143253178|OTHER||Difference|0.51||||0.1894|TWO_SIDED|95.0|-0.25|1.27|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of embryos||1.27|-0.25|0.1894
71868005|NCT03809429|143253178|OTHER||Difference|-0.03||||0.9361|TWO_SIDED|95.0|-0.68|0.63|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of Good-quality embryos||0.63|-0.68|0.9361
71868006|NCT03809429|143253179|OTHER||Difference|0.37||||0.2025|TWO_SIDED|95.0|-0.2|0.94|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Total number of blastocysts||0.94|-0.20|0.2025
71868007|NCT03809429|143253179|OTHER||Difference|0.12||||0.5946|TWO_SIDED|95.0|-0.31|0.54|||Negative binomial regression|Negative binomial regression model with treatment, age strata, and AMH group as factors.||Number of good-quality blastocysts||0.54|-0.31|0.5946
71868008|NCT03809429|143253185|OTHER||Difference|16.94|||<|0.0001|TWO_SIDED|95.0|12.13|21.74|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||21.74|12.13|<0.0001
71868009|NCT03809429|143253186|OTHER||Difference|1.56|||<|0.0001|TWO_SIDED|95.0|1.19|1.92|||ANOVA|ANOVA model with treatment, age strata, and AMH group as factors.||||1.92|1.19|<0.0001
71912643|NCT01367860|143344991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|1.11|<|0.05|TWO_SIDED|95.0|-2.29|2.23|||t-test, 2 sided|||||2.23|-2.29|<0.05
71912644|NCT01367860|143344992|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.17|<|0.05|TWO_SIDED|95.0|-1.67|3.08|||t-test, 2 sided|||||3.08|-1.67|<0.05
71912645|NCT01270958|143344993|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912646|NCT01270958|143344994|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912647|NCT01270958|143344995|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912648|NCT01270958|143344996|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912649|NCT01270958|143344997|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912650|NCT01270958|143344998|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912651|NCT01270958|143344999|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912652|NCT01270958|143345000|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912653|NCT01270958|143345001|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||<0.01
71912654|NCT01270958|143345002|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912655|NCT01270958|143345003|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912656|NCT01270958|143345004|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912657|NCT01270958|143345005|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912658|NCT01270958|143345006|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912659|NCT01270958|143345007|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912660|NCT01270958|143345008|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71868010|NCT03809429|143253187|OTHER||Difference|6.99||||0.1579|TWO_SIDED|95.0|-2.71|16.7|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.70|-2.71|0.1579
71912661|NCT01270958|143345009|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912662|NCT01270958|143345010|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912663|NCT01270958|143345011|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Comparison between Screening value and Visit 3 value|t-test, 2 sided|||||||>0.05
71912664|NCT01216397|143345032|SUPERIORITY_OR_OTHER||adjusted gMean ratio|99.4||||||90.0|94.2|105.0|||ANOVA|||Standard batch vs. Side batch||105.0|94.2|
71912665|NCT01216397|143345033|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|96.1|104.2|||ANOVA|||Standard batch vs. Side batch||104.2|96.1|
71912666|NCT01216397|143345034|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.1||||||90.0|94.7|105.8|||ANOVA|||Standard batch vs. Side batch||105.8|94.7|
71912667|NCT01216397|143345042|SUPERIORITY_OR_OTHER||adjusted gMean ratio|97.9||||||90.0|92.5|103.7|||ANOVA|||Standard batch vs. Side batch||103.7|92.5|
71912668|NCT01216397|143345043|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.4||||||90.0|95.7|105.4|||ANOVA|||||105.4|95.7|
71912669|NCT01216397|143345044|SUPERIORITY_OR_OTHER||adjusted gMean ratio|100.3||||||90.0|95.7|105.2|||ANOVA|||Standard batch vs. Side batch||105.2|95.7|
71912670|NCT02925312|143345057|SUPERIORITY|||||||0.05|||||||McNemar|||The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.||||0.05
71912671|NCT00971633|143345069|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.904|||||TWO_SIDED|95.0|0.796|1.028|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||1.028|0.796|
71912672|NCT00971633|143345069|NON_INFERIORITY_OR_EQUIVALENCE|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.991|||||TWO_SIDED|95.0|0.873|1.126|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.126|0.873|
71682887|NCT05153148|142883837|SUPERIORITY||Treatment Difference|-0.7|||=|0.043|TWO_SIDED|95.0|-1.3|0.0|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.0|-1.3|=0.043
71682888|NCT05153148|142883837|SUPERIORITY||Treatment Difference|-0.1|||=|0.687|TWO_SIDED|95.0|-0.8|0.5|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.5|-0.8|=0.687
71682889|NCT05153148|142883838|SUPERIORITY||Risk Difference (RD)|5.6|||=|0.349|TWO_SIDED|95.0|-6.1|17.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|17.4|-6.1|=0.349
71868011|NCT03809429|143253189|OTHER||Difference|7.66||||0.1134|TWO_SIDED|95.0|-1.82|17.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||17.14|-1.82|0.1134
71868012|NCT03809429|143253190|OTHER||Difference|8.81||||0.0642|TWO_SIDED|95.0|-0.52|18.14|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||18.14|-0.52|0.0642
71868013|NCT03809429|143253191|OTHER||Difference|7.74||||0.1002|TWO_SIDED|95.0|-1.49|16.97|||Regression, Logistic|Logistic regression model with treatment, age strata, and AMH group as factors.||||16.97|-1.49|0.1002
71868014|NCT02366468|143253201|NON_INFERIORITY|non-inferiority margin: -4 letters|Median Difference (Final Values)|-0.9||||0.002|TWO_SIDED|95.0|-3.04|1.27|||ANCOVA|including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.||The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.||1.27|-3.04|0.002
71868015|NCT02366468|143253205|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.62|TWO_SIDED|95.0|-17.1|28.56|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||28.56|-17.10|0.620
71912673|NCT00971633|143345070|NON_INFERIORITY_OR_EQUIVALENCE|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K.) ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.886|||||TWO_SIDED|95.0|0.813|0.966|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally||0.966|0.813|
71912674|NCT00971633|143345070|NON_INFERIORITY_OR_EQUIVALENCE|§ Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.951|||||TWO_SIDED|95.0|0.872|1.037|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally. Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally||1.037|0.872|
71912675|NCT01455415|143345076|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.3287|TWO_SIDED|95.0|0.83|1.73||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||1.73|0.83|0.3287
71912676|NCT01455415|143345077|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.0625|TWO_SIDED|95.0|0.98|2.51||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.||2.51|0.98|0.0625
71912677|NCT01455415|143345078|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.9448|TWO_SIDED|95.0|-0.21|0.22||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.22|-0.21|0.9448
71682890|NCT05153148|142883838|SUPERIORITY||Risk Difference (RD)|15.5|||=|0.017|TWO_SIDED|95.0|2.8|28.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|28.3|2.8|=0.017
71868016|NCT02366468|143253206|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.925|TWO_SIDED|95.0|-33.66|30.59|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates||||30.59|-33.66|0.925
71868017|NCT04797650|143253214|SUPERIORITY||Risk Difference (RD)|0.31|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.25|0.37||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.37|0.25|<0.0001
71868018|NCT04797650|143253214|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.27|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.45|0.27|<0.0001
71868019|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.38|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.31|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.46|0.31|<0.0001
71868020|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.36|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.26|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.45|0.26|<0.0001
71868021|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.3|0.45||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.45|0.30|<0.0001
71868022|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.4|STANDARD_ERROR_OF_MEAN|0.049|<|0.0001|TWO_SIDED|95.0|0.31|0.5||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.50|0.31|<0.0001
71868023|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.39|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.32|0.46||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.46|0.32|<0.0001
71868024|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.41|0.59||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.59|0.41|<0.0001
71868025|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.45|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.38|0.52||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.38|<0.0001
71868026|NCT04797650|143253215|SUPERIORITY||Risk Difference (RD)|0.49|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|0.4|0.58||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.58|0.40|<0.0001
71868027|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.004||0.3175|TWO_SIDED|95.0|0.0|0.01||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 4||0.01|-0.00|0.3175
71868028|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.102|TWO_SIDED|95.0|0.0|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.00|0.1020
71912678|NCT01455415|143345079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.12||0.4548|TWO_SIDED|95.0|-0.32|0.14||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.14|-0.32|0.4548
71912679|NCT01455415|143345080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.11||0.0272|TWO_SIDED|95.0|-0.44|-0.03||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.||-0.03|-0.44|0.0272
71912680|NCT01455415|143345081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.18||0.7344|TWO_SIDED|95.0|-0.42|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.42|0.7344
71912681|NCT01455415|143345082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.6007|TWO_SIDED|95.0|-0.42|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.42|0.6007
71912682|NCT01455415|143345083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|1.04||0.2987|TWO_SIDED|95.0|-3.13|0.96||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.96|-3.13|0.2987
71912683|NCT01455415|143345084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1769|TWO_SIDED|95.0|-0.85|0.16||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.16|-0.85|0.1769
71868029|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.3103|TWO_SIDED|95.0|-0.01|0.05||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 8||0.05|-0.01|0.3103
71868030|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.06|0.14||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.14|0.06|<0.0001
71868031|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.17|0.06|<0.0001
71868032|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.19|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.14|0.24||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.24|0.14|<0.0001
71868033|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|0.13|0.27||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.27|0.13|<0.0001
71868034|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.23|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.18|0.29||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo|Mantel Haenszel|||Week 20||0.29|0.18|<0.0001
71868035|NCT04797650|143253216|SUPERIORITY||Risk Difference (RD)|0.27|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.19|0.35||P-value was calculated by Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.35|0.19|<0.0001
71868036|NCT04797650|143253217|SUPERIORITY||Least Square (LS) Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.97||0.0039|TWO_SIDED|95.0|-4.7|-0.9||P-value was calculated by mixed model repeated measures (MMRM) analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-0.9|-4.7|0.0039
71682891|NCT05153148|142883838|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.014|TWO_SIDED|95.0|3.3|29.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of MDA responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.3|3.3|=0.014
71868037|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.12||0.0027|TWO_SIDED|95.0|-5.6|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 4||-1.2|-5.6|0.0027
71912684|NCT01455415|143345085|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.5119|TWO_SIDED|95.0|-0.48|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.24|-0.48|0.5119
71912685|NCT01455415|143345086|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.62||0.4335|TWO_SIDED|95.0|-1.72|0.74||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.74|-1.72|0.4335
71912686|NCT01455415|143345087|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.16||0.9653|TWO_SIDED|95.0|-0.31|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.30|-0.31|0.9653
71912687|NCT01455415|143345088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12||0.269|TWO_SIDED|95.0|-0.38|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.38|0.2690
71912688|NCT01455415|143345089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.9951|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9951
71912689|NCT01455415|143345090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.9726|TWO_SIDED|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.05|-0.05|0.9726
71912690|NCT01455415|143345091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.5497|TWO_SIDED|95.0|-0.04|0.08||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.08|-0.04|0.5497
71868038|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.0001|TWO_SIDED|95.0|-13.6|-5.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-5.1|-13.6|<0.0001
71868039|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-14.2|STANDARD_ERROR_OF_MEAN|2.47|<|0.0001|TWO_SIDED|95.0|-19.0|-9.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 8||-9.3|-19|<0.0001
71868040|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-23.0|STANDARD_ERROR_OF_MEAN|2.92|<|0.0001|TWO_SIDED|95.0|-28.8|-17.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-17.3|-28.8|<0.0001
71868041|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-29.3|STANDARD_ERROR_OF_MEAN|3.36|<|0.0001|TWO_SIDED|95.0|-35.9|-22.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-22.7|-35.9|< 0.0001
71868042|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-34.8|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|-41.4|-28.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-28.2|-41.4|< 0.0001
71868043|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-40.2|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|95.0|-47.8|-32.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-32.6|-47.8|< 0.0001
71682892|NCT05153148|142883839|SUPERIORITY||Treatment Difference|-3.73|||=|0.167|TWO_SIDED|95.0|-9.04|1.57|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|1.57|-9.04|=0.167
71682893|NCT05153148|142883839|SUPERIORITY||Treatment Difference|-6.43|||=|0.018|TWO_SIDED|95.0|-11.73|-1.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|-1.13|-11.73|=0.018
71682894|NCT05153148|142883839|SUPERIORITY||Treatment Difference|-5.23|||=|0.056|TWO_SIDED|95.0|-10.59|0.13|||MMRM||Point estimate and 95% CI were obtained from a MMRM model.||MMRM model included fixed effects for treatment group, visit, and treatment group-by-visit interaction, with baseline value and the randomization stratification factors (prior treatment with biologics or non-traditional DMARDs and region) as covariates, and the change from baseline as the dependent variable.|0.13|-10.59|=0.056
71868044|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-38.7|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|95.0|-45.9|-31.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-31.6|-45.9|< 0.0001
71868045|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-46.6|STANDARD_ERROR_OF_MEAN|4.17|<|0.0001|TWO_SIDED|95.0|-54.8|-38.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-38.4|-54.8|< 0.0001
71868046|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-45.9|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-53.4|-38.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-38.5|-53.4|< 0.0001
71868047|NCT04797650|143253217|SUPERIORITY||LS Mean Difference|-52.8|STANDARD_ERROR_OF_MEAN|4.36|<|0.0001|TWO_SIDED|95.0|-61.4|-44.2|||MMRM|||Week 24||-44.2|-61.4|< 0.0001
71868048|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by cochran mantel haenszel (CMH) test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
71868049|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
71868050|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
71868051|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
71868052|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
71868053|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
71868054|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71868055|NCT04797650|143253218|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71868056|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
71868057|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 12||||< 0.0001
71868058|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
71868059|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 16||||< 0.0001
71868060|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
71868061|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 20||||< 0.0001
71868062|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71868063|NCT04797650|143253219|SUPERIORITY||||||<|0.0001||||||P-value was calculated by CMH test stratified by baseline scalp hair loss (partial vs complete/near-complete) for responders in each treatment group compared to placebo.|Cochran-Mantel-Haenszel|||Week 24||||< 0.0001
71682895|NCT05153148|142883840|SUPERIORITY||Risk Difference (RD)|11.9|||=|0.186|TWO_SIDED|95.0|-5.7|29.4|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|29.4|-5.7|=0.186
71868064|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.5|< 0.0001
71868065|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-1.7|< 0.0001
71868066|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.3|-1.9|< 0.0001
71868067|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.2|-1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.5|-2.2|< 0.0001
71868068|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-2.0|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2|< 0.0001
71868069|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.7|-2.5|< 0.0001
71868070|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.5|-1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.5|< 0.0001
71868071|NCT04797650|143253220|SUPERIORITY||LS Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-2.8|-2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-2|-2.8|< 0.0001
71868072|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.8|-1.0||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1|-1.8|< 0.0001
71868073|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||-1.1|-2|< 0.0001
71868074|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-2.0|-1.2||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.2|-2|< 0.0001
71868075|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|-2.3|-1.4||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 16||-1.4|-2.3|< 0.0001
71868076|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.2|-1.3||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.3|-2.2|< 0.0001
71868077|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.4|-1.5||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 20||-1.5|-2.4|< 0.0001
71868078|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-2.5|-1.7||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.7|-2.5|< 0.0001
71868079|NCT04797650|143253221|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|-2.8|-1.8||P-value was calculated by MMRM with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||-1.8|-2.8|< 0.0001
71868080|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.05|0.12||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.12|0.05|< 0.0001
71868081|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.12|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.06|0.17||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 12||0.17|0.06|< 0.0001
71868082|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.33|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.27|0.38||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.38|0.27|< 0.0001
71868083|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.37|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.28|0.45||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||75% Relative Reduction: Week 24||0.45|0.28|< 0.0001
71868084|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.02|STANDARD_ERROR_OF_MEAN|0.009||0.0409|TWO_SIDED|95.0|0.0|0.03||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.03|0.00|0.0409
71868085|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.012|TWO_SIDED|95.0|0.01|0.09||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 12||0.09|0.01|0.012
71868086|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.21|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.16|0.26||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.26|0.16|< 0.0001
71868087|NCT04797650|143253222|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.038|<|0.0001|TWO_SIDED|95.0|0.16|0.31||P-value was calculated by mantel-haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||90% Relative Reduction: Week 24||0.31|0.16|< 0.0001
71912691|NCT01455415|143345092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1495|TWO_SIDED|95.0|-0.02|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.11|-0.02|0.1495
71912692|NCT01455415|143345093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.03||0.1297|TWO_SIDED|95.0|-0.11|0.01||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.01|-0.11|0.1297
71912693|NCT01455415|143345094|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.4279|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.4279
71912694|NCT01455415|143345095|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.5505|TWO_SIDED|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.||0.02|-0.04|0.5505
71912695|NCT01455415|143345096|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0604|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.0604
71912696|NCT01455415|143345097|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.038|STANDARD_ERROR_OF_MEAN|0.106||0.7174|TWO_SIDED|95.0|-0.248|0.171||Primary analysis was two-sided and performed at the 0.05 significance level.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.||0.171|-0.248|0.7174
71912697|NCT01455415|143345098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1511|TWO_SIDED|||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.||||0.1511
71912698|NCT01496274|143345118|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.|Wilcoxon signed-rank test|||A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.||||<0.0001
71868088|NCT04797650|143253223|SUPERIORITY||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|0.7|1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.4|0.7|< 0.0001
71868089|NCT04797650|143253223|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
71868090|NCT04797650|143253223|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|1.1|1.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||1.8|1.1|< 0.0001
71868091|NCT04797650|143253223|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|1.3|2.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.2|1.3|< 0.0001
71868092|NCT04797650|143253224|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|0.7|1.5||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.5|0.7|< 0.0001
71868093|NCT04797650|143253224|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|0.23|<|0.0001|TWO_SIDED|95.0|0.7|1.6||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 12||1.6|0.7|< 0.0001
71868094|NCT04797650|143253224|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|1.0|2.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2|1|< 0.0001
71868095|NCT04797650|143253224|SUPERIORITY||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|1.0|2.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Week 24||2.1|1|< 0.0001
71868096|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.4|< 0.0001
71868097|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 12||-0.9|-1.5|< 0.0001
71868098|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.1|-1.6|< 0.0001
71868099|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 16||-1.2|-1.8|< 0.0001
71868100|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.1|-1.6|< 0.0001
71868101|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 20||-1.4|-2|< 0.0001
71868102|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.3|-1.8|< 0.0001
71868103|NCT04797650|143253225|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-2.1|-1.4||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, and baseline value.|MMRM|||Week 24||-1.4|-2.1|< 0.0001
71868104|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.34|STANDARD_ERROR_OF_MEAN|0.046|<|0.0001|TWO_SIDED|95.0|0.25|0.43||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.43|0.25|< 0.0001
71868105|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|0.33|0.54||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 12||0.54|0.33|< 0.0001
71868106|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.35|0.51||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.51|0.35|< 0.0001
71868107|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.47|STANDARD_ERROR_OF_MEAN|0.052|<|0.0001|TWO_SIDED|95.0|0.37|0.57||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 16||0.57|0.37|< 0.0001
71868108|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.42|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.34|0.5||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.5|0.34|< 0.0001
71868109|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.54|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.44|0.63||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 20||0.63|0.44|< 0.0001
71912699|NCT01293084|143345159|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.2||||0.62|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.62
71912700|NCT01293084|143345160|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|2.3||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.32
71912701|NCT02690168|143345180|OTHER|||||||0.0053|||||||t-test, 2 sided|||||||0.0053
71912702|NCT02690168|143345181|OTHER|||||||0.477|||||||t-test, 2 sided|||||||0.477
71912703|NCT02690168|143345182|OTHER|||||||0.917|||||||t-test, 2 sided|||||||0.917
71912704|NCT02690168|143345184|OTHER|||||||0.53|||||||t-test, 2 sided|||||||0.53
71912705|NCT02823080|143345215|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71912706|NCT02823080|143345216|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71912707|NCT02823080|143345217|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71912708|NCT02823080|143345221|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71912709|NCT01375647|143345222|SUPERIORITY||Risk Difference (RD)|-2.9||||0.4|TWO_SIDED|95.0|-9.6|3.9|||Chi-squared|2 sided, not adjusted||||3.9|-9.6|0.4
71912710|NCT01375647|143345223|SUPERIORITY||Risk Difference (RD)|13.4||||4e-05|TWO_SIDED|95.0|7.0|19.8||2-sided, no adjustment|Chi-squared|||||19.8|7.0|0.00004
71912711|NCT01375647|143345224|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.5|TWO_SIDED||||||t-test, 2 sided|||Sabin type 1 shedding||||0.5
71912712|NCT01375647|143345224|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.2|TWO_SIDED||||||t-test, 2 sided|||Sabin type 2 shedding||||0.2
71912713|NCT01375647|143345224|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.1|TWO_SIDED||||||t-test, 2 sided|||Sabin type 3 shedding||||0.1
71912714|NCT01375647|143345226|SUPERIORITY||Risk Difference (RD)|-1.4|||||TWO_SIDED|95.0|-7.3|4.5||||||Sabin type 1||4.5|-7.3|
71912715|NCT01375647|143345226|SUPERIORITY||Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-7.2|0.9||||||Sabin type 2||0.9|-7.2|
71912716|NCT01375647|143345226|SUPERIORITY||Risk Difference (RD)|1.4|||||TWO_SIDED|95.0|-3.2|6.1||||||||6.1|-3.2|
71912717|NCT01375647|143345227|SUPERIORITY||Risk Difference (RD)|-33.7|||||TWO_SIDED|95.0|-40.7|-26.5||||||||-26.5|-40.7|
71912718|NCT01375647|143345227|SUPERIORITY||Risk Difference (RD)|-24.3|||||TWO_SIDED|95.0|-31.1|-17.5||||||||-17.5|-31.1|
71912719|NCT01375647|143345227|SUPERIORITY||Risk Difference (RD)|-45.6|||||TWO_SIDED|95.0|-52.6|-38.0||||||||-38.0|-52.6|
71912720|NCT01375647|143345228|SUPERIORITY|||||||0.981|||||||Wilcoxon (Mann-Whitney)|||||||0.981
71912721|NCT01375647|143345229|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71912722|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for RVR at Week 4.||||0.000
71912723|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Linear|||Binary logistic regression for gender at Week 4.||||0.018
71912724|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 4.||||0.062
71912725|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for HCV genotype at Week 4.||||0.050
71912726|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 4.||||0.001
71912727|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 4.||||0.001
71912728|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for EVR at Week 12.||||0.037
71912729|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for gender at Week 12.||||0.018
71912730|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.092|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 12.||||0.092
71912731|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for height at Week 12.||||0.001
71912732|NCT01392742|143345264|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 12.||||0.042
71912733|NCT02911519|143345299|SUPERIORITY||Risk Ratio (RR)|0.95||||0.59|TWO_SIDED|95.0|0.77|1.16|||Mixed Models Analysis||This is intention-to-treat analysis. The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk.|||1.16|0.77|0.59
71912734|NCT02911519|143345300|SUPERIORITY||Risk Ratio (RR)|0.98||||0.73|TWO_SIDED|95.0|0.87|1.1|||Mixed Models Analysis||The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk. This is intention-to-treat analysis.|||1.10|0.87|0.73
71912735|NCT02911519|143345301|SUPERIORITY||Slope|0.01||||0.94|TWO_SIDED|95.0|-0.36|0.39|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.39|-0.36|0.94
71912736|NCT02911519|143345301|SUPERIORITY||Slope|-0.19||||0.3|TWO_SIDED|95.0|-0.57|0.18|||Mixed Models Analysis||This is intention-to-treat analysis.|||0.18|-0.57|0.30
71912737|NCT02911519|143345303|SUPERIORITY||Slope|0.03||||0.61|TWO_SIDED|95.0|-0.1|0.17|||Mixed Models Analysis||This is an intention to treat analysis.|||0.17|-0.10|0.61
71912738|NCT02911519|143345304|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|Slope|0.04||||0.81|TWO_SIDED|95.0|-0.38|0.3|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|||0.30|-0.38|0.81
71912739|NCT02911519|143345304|SUPERIORITY|This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|Slope|-0.04||||0.81|TWO_SIDED|95.0|-0.38|0.29|||Mixed Models Analysis||This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|||0.29|-0.38|0.81
71912740|NCT02911519|143345304|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|Slope|0.16||||0.52|TWO_SIDED|95.0|-0.33|0.65|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|||0.65|-0.33|0.52
71912741|NCT02911519|143345304|SUPERIORITY|This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|Slope|0.19||||0.27|TWO_SIDED|95.0|-0.15|0.53|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|||0.53|-0.15|0.27
71912742|NCT02911519|143345305|SUPERIORITY|This analysis applies to SSFB objective domain in the first row.|Slope|-0.01||||0.33|TWO_SIDED|95.0|-0.01|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB objective domain in the first row.|||0.01|-0.01|0.33
71912743|NCT02911519|143345305|SUPERIORITY|This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|Slope|-0.01||||0.19|TWO_SIDED|95.0|-0.02|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|||0.01|-0.02|0.19
71868110|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.44|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.36|0.52||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.52|0.36|< 0.0001
71868111|NCT04797650|143253226|SUPERIORITY||Risk Difference (RD)|0.52|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.42|0.62||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||Week 24||0.62|0.42|< 0.0001
71868112|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.2|< 0.0001
71912744|NCT02911519|143345306|SUPERIORITY||Slope|0.01||||0.97|TWO_SIDED|95.0|-0.19|0.19|||Mixed Models Analysis||This is an intention to treat analysis.|||0.19|-0.19|0.97
71912745|NCT01444898|143345316|SUPERIORITY_OR_OTHER|||||||0.07|||||||Mixed Models Analysis|||||||.07
71912746|NCT01444898|143345317|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71912747|NCT01444898|143345318|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
71912748|NCT01444898|143345319|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
71912749|NCT01444898|143345320|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mixed Models Analysis|||||||.8
71912750|NCT01444898|143345321|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
71912751|NCT01444898|143345322|SUPERIORITY_OR_OTHER|||||||0.2|||||||Mixed Models Analysis|||||||.2
71912752|NCT01444898|143345323|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||.04
71912753|NCT01444898|143345324|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||.004
71912754|NCT02580591|143345326|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|99.0|-0.46|-0.11|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.11|-0.46|<0.0001
71912755|NCT02580591|143345326|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.6|-0.3|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.30|-0.60|<0.0001
71912756|NCT02580591|143345326|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.68|-0.37|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.37|-0.68|<0.0001
71912757|NCT02580591|143345327|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.4|-0.14|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.14|-0.40|
71912758|NCT02580591|143345327|SUPERIORITY||Median Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.59|-0.28|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.28|-0.59|<0.0001
71912759|NCT02580591|143345327|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.66|-0.35|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.35|-0.66|<0.0001
71912760|NCT02580591|143345328|SUPERIORITY||Adjusted Rate Ratio (%)|0.94|||||TWO_SIDED|95.0|0.673|1.314|||Negative binomial model||Empagliflozin 2.5 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.314|0.673|
71682896|NCT05153148|142883840|SUPERIORITY||Risk Difference (RD)|14.6|||=|0.101|TWO_SIDED|95.0|-2.8|32.1|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|32.1|-2.8|=0.101
71868113|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 12||-0.8|-1.4|< 0.0001
71868114|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-0.9|-1.3|< 0.0001
71912761|NCT02580591|143345328|SUPERIORITY||Adjusted Rate Ratio (%)|1.202||||0.2752|TWO_SIDED|97.75|0.818|1.766|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.766|0.818|0.2752
71912762|NCT02580591|143345328|SUPERIORITY||Adjusted Rate Ratio (%)|1.02||||0.9077|TWO_SIDED|97.75|0.693|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.501|0.693|0.9077
71912763|NCT02580591|143345328|SUPERIORITY||Adjusted Rate Ratio (%)|0.932|||||TWO_SIDED|95.0|0.682|1.274|||Negative binomial model|||For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.274|0.682|
71912764|NCT02580591|143345328|SUPERIORITY||Adjusted Rate Ratio (%)|1.258||||0.1438|TWO_SIDED|95.0|0.925|1.713||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.713|0.925|0.1438
71912765|NCT02580591|143345328|SUPERIORITY||Adjusted Rate Ratio (%)|1.051||||0.7543|TWO_SIDED|95.0|0.771|1.433||This is a nominal p-value.|Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk \[days\]) was used as offset.||1.433|0.771|0.7543
71912766|NCT02580591|143345329|SUPERIORITY||Mean Difference (Final Values)|-1.76|||||TWO_SIDED|95.0|-2.32|-1.2|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.20|-2.32|
71912767|NCT02580591|143345329|SUPERIORITY||Mean Difference (Final Values)|-3.04|||<|0.0001|TWO_SIDED|99.75|-3.91|-2.18|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.18|-3.91|<0.0001
71912768|NCT02580591|143345329|SUPERIORITY||Mean Difference (Final Values)|-3.43|||<|0.0001|TWO_SIDED|99.75|-4.3|-2.57|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-2.57|-4.30|<0.0001
71912769|NCT02580591|143345330|SUPERIORITY||Mean Difference (Final Values)|-0.049|||||TWO_SIDED|95.0|-0.069|-0.03|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.030|-0.069|
71912770|NCT02580591|143345330|SUPERIORITY||Mean Difference (Final Values)|-0.07|||<|0.0001|TWO_SIDED|99.75|-0.101|-0.039|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.039|-0.101|<0.0001
71868115|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 16||-1.1|-1.6|< 0.0001
71682897|NCT05153148|142883840|SUPERIORITY||Risk Difference (RD)|29.0|||=|0.002|TWO_SIDED|95.0|10.5|47.6|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PASI-75 responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|47.6|10.5|=0.002
71868116|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1|-1.5|< 0.0001
71868117|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.9|-1.3||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 20||-1.3|-1.9|< 0.0001
71868118|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.1|-1.6|< 0.0001
71682898|NCT05153148|142883841|SUPERIORITY||Risk Difference (RD)|4.5|||=|0.54|TWO_SIDED|95.0|-10.0|19.0|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.0|-10.0|=0.540
71868119|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied Thickness Hair Coverage: Week 24||-1.2|-1.8|< 0.0001
71868120|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.7|-1.1|< 0.0001
71868121|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 12||-0.8|-1.3|< 0.0001
71868122|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.7|-1.2|< 0.0001
71868123|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 16||-0.9|-1.4|< 0.0001
71868124|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-0.9|-1.3|< 0.0001
71912771|NCT02580591|143345330|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.01|<|0.0001|TWO_SIDED|99.75|-0.122|-0.06|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.060|-0.122|<0.0001
71912772|NCT02580591|143345331|SUPERIORITY||Median Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-3.9|-0.2|||Mixed effect Model Repeat MeasurementMix||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.2|-3.9|
71912773|NCT02580591|143345331|SUPERIORITY||Mean Difference (Final Values)|-3.9|||<|0.0001|TWO_SIDED|99.75|-6.8|-1.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, , treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-1.1|-6.8|<0.0001
71682899|NCT05153148|142883841|SUPERIORITY||Risk Difference (RD)|5.2|||=|0.466|TWO_SIDED|95.0|-8.8|19.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|19.3|-8.8|=0.466
71682900|NCT05153148|142883841|SUPERIORITY||Risk Difference (RD)|16.3|||=|0.034|TWO_SIDED|95.0|1.2|31.3|||Cochran-Mantel-Haenszel||MH risk difference was summarized along with the 2-sided 95% CI using MH stratum weights and the Sato variance estimator.||Comparisons of PhGA-PSO responder rates at Week 12 were made independently between each dose group and the placebo group using two-sided MH tests stratified on randomization stratification factors: prior treatment with biologics or non-traditional DMARDs and region.|31.3|1.2|=0.034
71912774|NCT02580591|143345331|SUPERIORITY||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|99.75|-6.6|-0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||-0.9|-6.6|<0.0001
71682901|NCT01953432|142883844|OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED||||||||Probability of 0.75 that the OR exceeded 1.00 (OR = 1.01, 95% CI = 0.98-1.05)|||||
71868125|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 20||-1.1|-1.6|< 0.0001
71868126|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.0|-1.5|< 0.0001
71868127|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||Satisfied evenness hair coverage: Week 24||-1.2|-1.8|< 0.0001
71868128|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.3|< 0.0001
71868129|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 12||-0.8|-1.4|< 0.0001
71868130|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-0.8|-1.3|< 0.0001
71868131|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 16||-1|-1.6|< 0.0001
71868132|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.0|-1.5|< 0.0001
71868133|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 20||-1.1|-1.7|< 0.0001
71868134|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.0|-1.5|< 0.0001
71912775|NCT02580591|143345331|SUPERIORITY||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.5|0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.9|-1.5|
71912776|NCT02580591|143345331|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.0047|TWO_SIDED|99.75|-3.6|0.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.1|-3.6|0.0047
71912777|NCT02580591|143345331|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.0202|TWO_SIDED|99.75|-3.3|0.4|||Mixed effect Model Repeat Measurement|||For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre-existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.||0.4|-3.3|0.0202
71912778|NCT03051217|143345339|SUPERIORITY||Estimated difference in responder rate|65.1|||||TWO_SIDED|95.0|48.22|81.9|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||81.90|48.22|
71912779|NCT03051217|143345339|SUPERIORITY||Estimated difference in responder rate|79.1|||||TWO_SIDED|95.0|65.1|93.17|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||93.17|65.10|
71912780|NCT03051217|143345339|SUPERIORITY||Odds Ratio (OR)|31.695|||<|0.0001|TWO_SIDED|97.5|5.129|195.877||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||195.877|5.129|<0.0001
71912781|NCT03051217|143345339|SUPERIORITY||Odds Ratio (OR)|79.112|||<|0.0001|TWO_SIDED|97.5|11.739|533.168||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||533.168|11.739|<0.0001
71912782|NCT03051217|143345340|SUPERIORITY||Estimated difference in responder rate|52.7|||||TWO_SIDED|95.0|29.95|75.39|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||75.39|29.95|
71868135|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.8|-1.2||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyebrows: Week 24||-1.2|-1.8|< 0.0001
71868136|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.1|< 0.0001
71868137|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 12||-0.7|-1.2|< 0.0001
71868138|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.7|-1.2|< 0.0001
71912783|NCT03051217|143345340|SUPERIORITY||Estimated difference in responder rate|66.7|||||TWO_SIDED|95.0|43.34|90.15|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||90.15|43.34|
71912784|NCT03051217|143345340|SUPERIORITY||Odds Ratio (OR)|38.193|||<|0.0001|TWO_SIDED|97.5|6.113|238.619||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||238.619|6.113|<0.0001
71912785|NCT03051217|143345340|SUPERIORITY||Odds Ratio (OR)|69.58|||<|0.0001|TWO_SIDED|97.5|11.138|434.659||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||434.659|11.138|<0.0001
71912786|NCT03051217|143345341|SUPERIORITY||Estimated difference in responder rate|53.6|||||TWO_SIDED|95.0|30.67|76.47|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||76.47|30.67|
71912787|NCT03051217|143345341|SUPERIORITY||Estimated difference in responder rate|75.5|||||TWO_SIDED|95.0|51.95|99.04|||Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||99.04|51.95|
71912788|NCT03051217|143345341|SUPERIORITY||Odds Ratio (OR)|38.696|||<|0.0001|TWO_SIDED|97.5|6.047|247.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||247.634|6.047|<0.0001
71912789|NCT03051217|143345341|SUPERIORITY||Odds Ratio (OR)|100.459|||<|0.0001|TWO_SIDED|97.5|15.54|649.437||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||649.437|15.540|<0.0001
71912790|NCT03051217|143345342|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.1|-3.844||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.844|-9.100|<0.0001
71912791|NCT03051217|143345342|SUPERIORITY||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|TWO_SIDED|97.5|-9.099|-3.91||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.910|-9.099|<0.0001
71912792|NCT03051217|143345343|SUPERIORITY||Adjusted Mean Treatment Difference|-3.1|||<|0.0001|TWO_SIDED|95.0|-4.265|-2.002||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-2.002|-4.265|<0.0001
71912793|NCT03051217|143345343|SUPERIORITY||Adjusted Mean Treatment Difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.295|-3.069||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.||-3.069|-5.295|<0.0001
71912794|NCT00109772|143345346|SUPERIORITY_OR_OTHER|||||||0.894||95.0|||||Cochran-Mantel-Haenszel|controlled for centers||||||.8940
71912795|NCT03437044|143345363|SUPERIORITY|||||||0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||0.001
71912796|NCT03437044|143345364|SUPERIORITY||||||<|0.001|||||||ANCOVA|the corresponding baseline value of platelet reactivity was used as covariate||||||<0.001
71912797|NCT01359046|143345365|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.30
71912798|NCT01359046|143345366|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71912799|NCT04539262|143345367|SUPERIORITY||Least Square Mean Difference by Day 7|-0.66|STANDARD_ERROR_OF_MEAN|0.4||0.1117|TWO_SIDED|95.0|-1.49|0.16||Least square (LS) Mean, Standard Error (SE), 95% CI and p-value were from Analysis of covariance (ANCOVA) with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.49|0.1117
71912800|NCT04539262|143345367|SUPERIORITY||LS Mean Difference by Day 7|-0.35|STANDARD_ERROR_OF_MEAN|0.4||0.3793|TWO_SIDED|95.0|-1.16|0.46||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.46|-1.16|0.3793
71912801|NCT04539262|143345367|SUPERIORITY||LS Mean Difference by Day 7|-0.24|STANDARD_ERROR_OF_MEAN|0.37||0.5248|TWO_SIDED|95.0|-1.0|0.52||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate|ANCOVA|||||0.52|-1.00|0.5248
71912802|NCT04539262|143345367|SUPERIORITY||LS Mean Difference by Day 7|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.461|TWO_SIDED|95.0|-0.94|0.44|||ANCOVA|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate||||0.44|-0.94|0.4610
71912803|NCT04539262|143345367|SUPERIORITY||LS Mean Difference by Day 7|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5006|TWO_SIDED|95.0|-0.4|0.81||LS Mean (SE), 95% CI and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.81|-0.40|0.5006
71912804|NCT04539262|143345368|SUPERIORITY||LS Mean Difference by Day 7|0.33|STANDARD_ERROR_OF_MEAN|0.34||0.3417|TWO_SIDED|95.0|-0.37|1.02||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.02|-0.37|0.3417
71912805|NCT04539262|143345368|SUPERIORITY||LS Mean Difference by Day 7|0.49|STANDARD_ERROR_OF_MEAN|0.35||0.1803|TWO_SIDED|95.0|-0.24|1.21||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||1.21|-0.24|0.1803
71912806|NCT04539262|143345368|SUPERIORITY||LS Mean Difference by Day 7|-0.55|STANDARD_ERROR_OF_MEAN|0.35||0.1233|TWO_SIDED|95.0|-1.27|0.16||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.16|-1.27|0.1233
71912807|NCT04539262|143345368|SUPERIORITY||LS Mean Difference by Day 7|0.08|STANDARD_ERROR_OF_MEAN|0.35||0.8203|TWO_SIDED|95.0|-0.64|0.8||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.80|-0.64|0.8203
71912808|NCT04539262|143345368|SUPERIORITY||LS Mean Difference by Day 7|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.6458|TWO_SIDED|95.0|-0.65|0.41||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.41|-0.65|0.6458
71912809|NCT04539262|143345369|SUPERIORITY||LS Mean Difference by Day 7|-0.22|STANDARD_ERROR_OF_MEAN|0.4||0.5951|TWO_SIDED|95.0|-1.05|0.61||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.61|-1.05|0.5951
71912810|NCT04539262|143345369|SUPERIORITY|LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|LS Mean Difference by Day 7|-0.71|STANDARD_ERROR_OF_MEAN|0.4||0.0872|TWO_SIDED|95.0|-1.54|0.11|||ANCOVA|||||0.11|-1.54|0.0872
71682902|NCT01953432|142883844|OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED||||||||Probability of 0.96 that the odds ratio exceeded 1.00 (OR = 1.03, 95% CI = 1.00-1.07)|||||
71682903|NCT01712334|142883845|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%-125%.|Ratio (Fieller's theorem)|100.9|||||TWO_SIDED|90.0|99.5|102.3||||||||102.3|99.5|
71912811|NCT04539262|143345369|SUPERIORITY||LS Mean Difference by Day 7|-0.19|STANDARD_ERROR_OF_MEAN|0.36||0.6031|TWO_SIDED|95.0|-0.94|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.94|0.6031
71912812|NCT04539262|143345369|SUPERIORITY||LS Mean Difference by Day 7|0.12|STANDARD_ERROR_OF_MEAN|0.37||0.7578|TWO_SIDED|95.0|-0.64|0.87||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.87|-0.64|0.7578
71912813|NCT04539262|143345369|SUPERIORITY||LS Mean Difference by Day 7|0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8846|TWO_SIDED|95.0|-0.48|0.56||LS Mean (SE), 95% CI, and p-value were from ANCOVA with baseline viral load as a covariate.|ANCOVA|||||0.56|-0.48|0.8846
71912814|NCT02665468|143345402|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71912815|NCT00047853|143345419|OTHER||||||<|0.001|||||||ANOVA|||||||< 0.001
71912816|NCT00047853|143345420|OTHER|||||||9.3e-05|||||||t-test, 2 sided|||||||0.000093
71912817|NCT02443805|143345422|SUPERIORITY||||||<|0.0001||||||Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.|ANCOVA|||||||<0.0001
71912818|NCT04362813|143345425|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2874|TWO_SIDED|95.0|0.76|2.54|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5).||2.54|0.76|0.2874
71912819|NCT04362813|143345426|SUPERIORITY||Odds Ratio (OR)|0.67||||0.3303|TWO_SIDED|95.0|0.3|1.5|||Regression, Logistic|||Odds ratio is based on a Logistic regression model adjusted by treatment, region (North America vs Europe), and baseline 9-point ordinal scale (\<=4, \>=5)||1.50|0.30|0.3303
71912820|NCT01142193|143345469|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
71912821|NCT01142193|143345469|SUPERIORITY_OR_OTHER||Median Difference (Net)|18.5|||||TWO_SIDED|95.0|8.53|28.1|||Hodges-Lehmann|||||28.1|8.53|
71912822|NCT01142193|143345470|SUPERIORITY_OR_OTHER||Difference in Percentages|14.7||||0.013|||||||Fisher Exact|||||||0.013
71912823|NCT01142193|143345471|SUPERIORITY_OR_OTHER||Difference in Percentages|16.3||||0.007|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.007
71912824|NCT01142193|143345472|SUPERIORITY_OR_OTHER||Median Difference (Net)|25.36|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71912825|NCT01142193|143345473|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71912826|NCT01142193|143345477|SUPERIORITY_OR_OTHER||Median Difference (Net)|23.61||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71682904|NCT00232596|142883847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA|||||||<0.001
71682905|NCT00232596|142883848|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71868139|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 16||-0.8|-1.3|< 0.0001
71912827|NCT01142193|143345478|SUPERIORITY_OR_OTHER||Difference in Percentages|13.4||||0.048|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.||||||0.048
71912828|NCT01459068|143345479|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.59|-0.4||a priori threshold for statistical significance was 0.05.|longitudinal model|longitudinal to model within-person change in mean scores||||-0.40|-0.59|<0.001
71912829|NCT01459068|143345480|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|power calculations were not done for secondary outcomes|Mean Difference (Net)|-0.44|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.59|-0.28|||longitudinal model|||||-0.28|-0.59|<0.001
71912830|NCT01459068|143345481|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|95.0|-0.51|-0.35||a priori threshold for significance set at 0.05|longitudinal model|longitudinal analysis modeling within-person change in mean scores||||-0.35|-0.51|<0.001
71912831|NCT01459068|143345482|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations on secondary outcomes|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.61|-0.34|||longitudinal model|||||-0.34|-0.61|<0.001
71912832|NCT01459068|143345483|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||longitudinal model|||||-0.15|-0.34|<0.001
71912833|NCT01459068|143345484|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|no power calculations for secondary measures|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.26||0.896|TWO_SIDED|95.0|-0.44|0.5|||longitudinal model|||||0.50|-0.44|0.896
71912834|NCT01015820|143345500|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.001
71912835|NCT01015820|143345501|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05||||0.03
71912836|NCT00701441|143345502|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||For comparing pre versus post, paired t tests were used. We considered tests in the hypothesized direction conclusive|t-test, 2 sided|For each comparison, we tested at the 0.05 level with double-sided P values. We used no correction for multiple testing when declaring significance.||Flow mediated dilation = \[(average maximum dilation post cuff deflation - average baseline diameter)/ average baseline diameter\]100||||0.02
71912837|NCT00701441|143345503|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||We only consider tests in the hypothesized direction conclusive, so testing is conservative from that perspective. However, we used no correction for multiple testing when declaring significance|t-test, 2 sided|||For comparing pre- versus post-treatment, paired t tests were used. For each variable and comparison, we tested at the 0.05 level with double-sided P values.||||0.02
71912838|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.||||||0.09|||||||Paired t-test|||P-value comparing AL between G6 and IOLM||||0.09
71912839|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing AL between G6 and LS||||<0.001
71912840|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing AL between IOLM and LS||||<0.0001
71912841|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing CCT between G6 and LS||||<0.0001
71912842|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing ACD between G6 and IOLM||||<0.0001
71912843|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing ACD between G6 and LS||||<0.01
71912844|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.02|||||||Paired t-test|||P-value comparing ACD between IOLM and LS||||0.02
71912845|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing LT between G6 and LS||||<0.01
71912846|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and IOLM||||<0.0001
71912847|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and LS||||<0.0001
71912848|NCT01961089|143345508|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing WtW between IOLM and LS||||<0.001
71912849|NCT01961089|143345509|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||ANOVA|||Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.||||0.05
71912850|NCT01961089|143345510|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.13|||||||Paired t-test|||P-value comparing SimK between G6 and IOLM||||0.13
71912851|NCT01961089|143345510|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.25|||||||Paired t-test|||P-value comparing SimK between G6 and LS||||0.25
71912852|NCT01961089|143345510|EQUIVALENCE|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.21|||||||Paired t-test|||P-value comparing SimK between IOLM and LS||||0.21
71912853|NCT04209400|143345513|NON_INFERIORITY|P \< 0.05 is considered a statistically significant difference in seroconversion between the two groups.||||||1|||||||Chi-squared|||The null hypothesis is that the vaccines equally affect the achievement of seroconversion level.||||1
71912854|NCT01203787|143345542|SUPERIORITY_OR_OTHER|||||||0.0262|TWO_SIDED||||||Wilcoxon rank sum test|||||||0.0262
71912855|NCT01041404|143345587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Log Rank|||||0.85|0.59|0.0002
71868140|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-0.8|-1.3|< 0.0001
71868141|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.5|-1.0||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 20||-1.0|-1.5|< 0.0001
71868142|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-0.9|-1.4|< 0.0001
71912856|NCT01041404|143345589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.0|0.58|0.85|||Log Rank|||||0.85|0.58|0.0003
71912857|NCT01041404|143345590|SUPERIORITY_OR_OTHER||Difference in Response Rates|12.8||||0.0017|TWO_SIDED|95.0|4.7|20.9|||Chi-squared|||||20.9|4.7|0.0017
71912858|NCT01041404|143345592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.73|||Log Rank|||||0.73|0.40|<0.0001
71868143|NCT04797650|143253227|SUPERIORITY||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.6|-1.1||P-value was calculated by MMRM analysis with effects for treatment, visit, treatment-by-visit interaction, baseline value, and baseline SALT score.|MMRM|||How satisfied with your eyelashes: Week 24||-1.1|-1.6|< 0.0001
71912859|NCT01041404|143345593|SUPERIORITY_OR_OTHER||Difference in Clinical Benefit Rate|9.6||||0.0081|TWO_SIDED|95.0|2.4|16.9|||Chi-squared|||||16.9|2.4|0.0081
71868144|NCT04797650|143253228|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.29||0.1206|TWO_SIDED|95.0|-0.1|1.0||P-value was calculated by analysis of covariance (ANCOVA) analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||1.0|-0.1|0.1206
71912860|NCT01041404|143345593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66|||||TWO_SIDED|95.0|1.14|2.41||||||||2.41|1.14|
71912861|NCT01041404|143345594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.0046|TWO_SIDED|95.0|0.6|0.91|||Log Rank|||||0.91|0.60|0.0046
71912862|NCT01685203|143345606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381|TWO_SIDED||||||Regression, Logistic|Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors||||||0.381
71912863|NCT01685203|143345606|SUPERIORITY_OR_OTHER_LEGACY|||||||0.086|TWO_SIDED|||||Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.|Stratum-adjusted Mantel-Haenszel|||||||0.086
71912864|NCT00383708|143345610|OTHER||||||<|0.0001|||||||Exact test|One-sided p value||The percentage of subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71912865|NCT00383708|143345611|OTHER|||||||0.1654||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with pegvisomant (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.1654
71912866|NCT00383708|143345611|OTHER|||||||0.0115||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with lanreotide Autogel (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0115
71912867|NCT00383708|143345611|OTHER|||||||0.0003||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with octreotide LAR (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.0003
71868145|NCT04797650|143253228|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.34||0.5367|TWO_SIDED|95.0|-0.5|0.9||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Anxiety||0.9|-0.5|0.5367
71868146|NCT04797650|143253228|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.29||0.0064|TWO_SIDED|95.0|0.2|1.3||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.3|0.2|0.0064
71868147|NCT04797650|143253228|SUPERIORITY||LS Mean Difference|1.1|STANDARD_ERROR_OF_MEAN|0.33||0.0011|TWO_SIDED|95.0|0.4|1.7||P-value was calculated by ANCOVA analysis with effects for treatment, visit, baseline SALT score, and baseline HADS value.|ANCOVA|||Depression||1.7|0.4|0.0011
71868148|NCT04797650|143253229|SUPERIORITY||Risk Difference (RD)|0.24|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.19|0.3||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.3|0.19|< 0.0001
71868149|NCT04797650|143253229|SUPERIORITY||Risk Difference (RD)|0.25|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.18|0.33||P-value was calculated by the Mantel-Haenszel estimate stratified by baseline scalp hair loss (partial vs complete/near-complete) for each treatment group compared to placebo.|Mantel Haenszel|||||0.33|0.18|< 0.0001
71868150|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||ANOVA|||Region of Interest is left anterior insula.||||0.2960
71868151|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.345||95.0|||||ANOVA|||Region of interest is left anterior insula.||||0.3450
71868152|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.1192||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.1192
71868153|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||ANOVA|||Region of interest is left anterior putamen.||||0.6639
71868154|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.8295||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.8295
71868155|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.0078||95.0|||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.||||0.0078
71868156|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex.||||0.7153
71912868|NCT00383708|143345612|OTHER|||||||0.084||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||0.084
71912869|NCT00383708|143345612|OTHER||||||<|0.0001||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup non diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71868157|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.8511||95.0|||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex||||0.8511
71868158|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.4228||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.4228
71868159|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.0611||95.0|||||ANOVA|||Region of interest is left parietal cortex||||0.0611
71868160|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.9879||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.9879
71868161|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.2065||95.0|||||ANOVA|||Region of interest is left premotor cortex||||0.2065
71868162|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.1837||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.1837
71868163|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.8195||95.0|||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area||||0.8195
71868164|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||ANOVA|||Region of interest is left thalamus||||0.6420
71868165|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.7475||95.0|||||ANOVA|||Region of interest is left thalamus||||0.7475
71868166|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.9049||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.9049
71868167|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||ANOVA|||Region of interest is left visual cortex||||0.1830
71868168|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.5318||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.5318
71868169|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.9588||95.0|||||ANOVA|||Region of interest is right anterior insula||||0.9588
71868170|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.7551||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7551
71868171|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.7895||95.0|||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex||||0.7895
71868172|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.9494||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.9494
71868173|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.4482||95.0|||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex||||0.4482
71868174|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.9343||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.9343
71868175|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.7711||95.0|||||ANOVA|||Region of interest is right parietal cortex||||0.7711
71868176|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.4755||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.4755
71868177|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.3982||95.0|||||ANOVA|||Region of interest is right premotor cortex||||0.3982
71868178|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.4622||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4622
71868179|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.4604||95.0|||||ANOVA|||Region of interest is right thalamus||||0.4604
71868180|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.2485||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.2485
71868181|NCT00657020|143253242|SUPERIORITY_OR_OTHER|||||||0.1931||95.0|||||ANOVA|||Region of interest is right visual cortex||||0.1931
71682906|NCT01253174|142883871|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|102.26||||||90.0|96.65|108.2||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||108.20|96.65|
71682907|NCT01253174|142883872|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|101.13||||||90.0|97.65|104.75||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.75|97.65|
71682908|NCT01253174|142883873|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.66||||||90.0|93.37|104.24||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||104.24|93.37|
71868182|NCT00657020|143253243|SUPERIORITY_OR_OTHER|||||||0.4535||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.4535
71682909|NCT01253174|142883874|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.45||||||90.0|96.7|102.28||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||102.28|96.70|
71868183|NCT00657020|143253243|SUPERIORITY_OR_OTHER|||||||0.1811||95.0|||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.||||0.1811
71868184|NCT00657020|143253244|SUPERIORITY_OR_OTHER|||||||0.6261||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.6261
71868185|NCT00657020|143253244|SUPERIORITY_OR_OTHER|||||||0.0106||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.0106
71868186|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.5544
71868187|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.6716||95.0|||||ANOVA|||Region of interest is left parietal cortex.||||0.6716
71868188|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.7511||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7511
71868189|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.7959||95.0|||||ANOVA|||Region of interest is left superior occipital cortex.||||0.7959
71868190|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.6418||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.6418
71868191|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.2205||95.0|||||ANOVA|||Region of interest is left visual cortex.||||0.2205
71868192|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.5135||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.5135
71868193|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.9781||95.0|||||ANOVA|||Region of interest is right parietal cortex.||||0.9781
71868194|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.3755||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.3755
71868195|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.2612||95.0|||||ANOVA|||Region of interest is right premotor cortex.||||0.2612
71868196|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.8486||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8486
71868197|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.8318||95.0|||||ANOVA|||Region of interest is right superior occipital cortex.||||0.8318
71868198|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.7554||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.7554
71868199|NCT00657020|143253245|SUPERIORITY_OR_OTHER|||||||0.5421||95.0|||||ANOVA|||Region of interest is right visual cortex.||||0.5421
71868200|NCT00657020|143253246|SUPERIORITY_OR_OTHER|||||||0.1963||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.1963
71868201|NCT00657020|143253246|SUPERIORITY_OR_OTHER|||||||0.0959||95.0|||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.||||0.0959
71868202|NCT00657020|143253247|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.||||0.5400
71868203|NCT00657020|143253247|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||ANOVA|||Null hypothesis considered the treatments in comparison to be equal.||||0.1800
71868204|NCT01144052|143253248|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed as this was a pilot study serving to generate first data and hypotheses.||||||0.125||95.0|||||Log Rank|||||||0.125
71868205|NCT01144052|143253249|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||non-parametric|||||||0.447
71868206|NCT01144052|143253250|SUPERIORITY_OR_OTHER|||||||0.447|||||||non-parametric|||||||0.447
71868207|NCT01144052|143253251|SUPERIORITY_OR_OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71868208|NCT01144052|143253253|NON_INFERIORITY_OR_EQUIVALENCE|No statistical hypothesis tests for efficacy were performed, as this was pilot study serving to generate first data and hypotheses.||||||0.234||95.0|||||Wilcoxon (Mann-Whitney)|p-value refers to nT2L at month 12||||||0.234
71868209|NCT00105001|143253257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.09
71868210|NCT00105001|143253257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.1|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u\[|||1.1|0.4|0.10
71868211|NCT00105001|143253257|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.62||||0.04|TWO_SIDED|95.0|0.6|1.0|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||1.0|0.6|0.04
71868212|NCT00105001|143253258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.55
71868213|NCT00105001|143253259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.009
71868214|NCT00105001|143253259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.51|TWO_SIDED|95.0|0.5|1.4|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up|||1.4|0.5|0.51
71868215|NCT00105001|143253259|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.004|TWO_SIDED|95.0|0.3|0.8|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up|||0.8|0.3|0.004
71912870|NCT00383708|143345613|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'while taking final dose during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71868216|NCT00105001|143253260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.93
71868217|NCT00105001|143253261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96|TWO_SIDED|||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox|||||||0.96
71868218|NCT01534689|143253281|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71868219|NCT01534689|143253282|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||results at 12 weeks compared to baseline||||<0.0001
71868220|NCT05383508|143253311|OTHER||Geometric LS Mean Ratio (%)|17.05|||||TWO_SIDED|95.0|10.69|27.19||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||27.19|10.69|
71868221|NCT05383508|143253311|OTHER||Geometric LS Mean Ratio (%)|19.47|||||TWO_SIDED|95.0|11.89|31.87||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the Cmax ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||31.87|11.89|
71868222|NCT05383508|143253312|OTHER||Median Difference (Net)|3.0|||||TWO_SIDED|95.0|0.0|11.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||11.00|0.00|
71868223|NCT05383508|143253312|OTHER||Mean Difference (Net)|2.0|||||TWO_SIDED|95.0|0.0|4.0||95% confidence intervals are provided for this analysis.|Wilcoxon signed rank test||Hodges-Lehmann estimator of location shift and Moses 95% CI|The objective of this study was to determine the Tmax difference of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||4.00|0.00|
71868224|NCT05383508|143253313|OTHER||Geometric LS Mean Ratio (%)|28.29|||||TWO_SIDED|95.0|16.0|50.04||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||50.04|16.00|
71912871|NCT00383708|143345613|OTHER||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'at any time during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor \> 0.3.||||<0.0001
71912872|NCT01576406|143345652|SUPERIORITY||Geometric mean ratio|91.2|||||TWO_SIDED|90.0|57.47|144.72||||||Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.||144.72|57.47|
71868225|NCT05383508|143253313|OTHER||Geometric LS Mean Ratio (%)|26.16|||||TWO_SIDED|95.0|12.74|53.69||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the AUC0-infinity ratio of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||53.69|12.74|
71912873|NCT01576406|143345652|SUPERIORITY||Geometric mean ratio|143.82|||||TWO_SIDED|90.0|89.11|232.12||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||232.12|89.11|
71868226|NCT05383508|143253314|OTHER||Geometric LS Mean Ratio (%)|10.84|||||TWO_SIDED|95.0|5.57|21.1||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||21.10|5.57|
71868227|NCT05383508|143253314|OTHER||Geometric LS Mean Ratio (%)|16.83|||||TWO_SIDED|95.0|9.93|28.53||95% confidence intervals are provided for this analysis.|Mixed Models Analysis|The model included terms for sequence, period, and product exposure as fixed effects and subject as a categorical random effect.|Analysis was performed on log transformed data with Kenward Roger degrees of freedom approximation. Ratio and related 95% CI were derived by exponentiating the estimates obtained on the log scale.|The objective of this study was to determine the maximum ratio of background-corrected concentration over time of P4M3 variants:Cigarettes along with the corresponding 95% confidence intervals||28.53|9.93|
71868228|NCT03484273|143253327|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated Measures ANOVA||Repeated Measured ANOVA was used to compare the 4 compression garment configurations.||||<0.001
71868229|NCT03484273|143253328|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
71868230|NCT03484273|143253329|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
71868231|NCT03484273|143253330|SUPERIORITY|||||||0.01|||||||Repeated Measures ANOVA|||||||0.01
71868232|NCT03484273|143253331|SUPERIORITY||||||<|0.001|||||||Repeated Measures ANOVA|||||||<0.001
71912874|NCT01576406|143345652|SUPERIORITY||Geometric mean ratio|108.87|||||TWO_SIDED|90.0|70.13|168.99||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||168.99|70.13|
71912875|NCT01576406|143345652|SUPERIORITY||Geometric mean ratio|72.63|||||TWO_SIDED|90.0|49.07|107.5||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||107.50|49.07|
71912876|NCT01576406|143345678|SUPERIORITY||Percentage of ratio of geometric mean|91.12|||||TWO_SIDED|90.0|56.56|146.79||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||146.79|56.56|
71912877|NCT01576406|143345678|SUPERIORITY||Percentage of ratio of geometric mean|149.54|||||TWO_SIDED|90.0|91.85|243.46||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||243.46|91.85|
71868233|NCT03484273|143253332|SUPERIORITY|||||||0.001|||||||Repeated Measures ANOVA|||||||0.001
71868234|NCT03484273|143253333|SUPERIORITY|||||||0.04|||||||Repeated Measures ANOVA|||||||0.04
71868235|NCT00294515|143253363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4|||<=|0.0002|TWO_SIDED|95.0|0.25|0.66|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.66|0.25|<=0.0002
71868236|NCT00294515|143253364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.2|||<|0.0001||95.0|0.11|0.37|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.37|0.11|<0.0001
71868237|NCT00294515|143253365|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||0.0001||95.0|0.22|0.6|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.60|0.22|0.0001
71868238|NCT00294515|143253366|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.0126||95.0|0.35|0.88|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.88|0.35|0.0126
71868239|NCT00294515|143253367|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.01||95.0|0.34|0.86|||Cochran-Mantel-Haenszel|Stratified by Center Pools||||0.86|0.34|0.0100
71868240|NCT01151410|143253424|NON_INFERIORITY_OR_EQUIVALENCE|Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.|Mean Difference (Net)|0.31||||0.004|ONE_SIDED|95.0|-2.4||||ANCOVA||||||-2.40|0.0040
71868241|NCT02327351|143253459|SUPERIORITY||survival distribution function|86.0||||0.95|TWO_SIDED|95.0|79.0|94.0|||Gray test|||||94|79|0.95
71868242|NCT02327351|143253465|SUPERIORITY|||||||0.35|||||||Log Rank|||||||0.35
71868243|NCT03988920|143253556|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7439|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.7439
71868244|NCT01237587|143253568|SUPERIORITY||LS mean change difference|-0.65|STANDARD_ERROR_OF_MEAN|0.33||0.052|TWO_SIDED|95.0|-1.3|0.0|||Repeated Measures|||||0.00|-1.30|0.052
71868245|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.36||0.059|TWO_SIDED|95.0|-1.4|0.03|||Mixed Models Analysis|||Worst Pain||0.03|-1.40|.059
71868246|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.319||0.059|TWO_SIDED|95.0|-1.24|0.02|||Mixed Models Analysis|||Least Pain||0.02|-1.24|0.059
71868247|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.365||0.165|TWO_SIDED|95.0|-1.23|0.21|||Mixed Models Analysis|||Pain Right Now||0.21|-1.23|.165
71868248|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.344||0.005|TWO_SIDED|95.0|-1.65|-0.3|||Mixed Models Analysis|||General Activity||-0.30|-1.65|0.005
71868249|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.356||0.128|TWO_SIDED|95.0|-1.25|0.16|||Mixed Models Analysis|||Mood||0.16|-1.25|.128
71912878|NCT01576406|143345678|SUPERIORITY||Percentage of ratio of geometric mean|114.08|||||TWO_SIDED|90.0|73.57|176.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||176.89|73.57|
71912879|NCT01576406|143345678|SUPERIORITY||Percentage of ratio of geometric mean|64.67|||||TWO_SIDED|90.0|39.5|105.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||105.89|39.50|
71868250|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.352||0.56|TWO_SIDED|95.0|-0.9|0.49|||Mixed Models Analysis|||Walking ability||0.49|-0.90|.560
71868251|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.371||0.448|TWO_SIDED|95.0|-1.01|0.45|||Mixed Models Analysis|||Normal Work||0.45|-1.01|0.448
71868252|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.312||0.011|TWO_SIDED|95.0|-1.42|-0.19|||Mixed Models Analysis|||Relations With Other||-0.19|-1.42|.011
71868253|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.454||0.443|TWO_SIDED|95.0|-1.25|0.55|||Mixed Models Analysis|||Sleep||0.55|-1.25|.443
71868254|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.338||0.39|TWO_SIDED|95.0|-0.96|0.38|||Mixed Models Analysis|||Enjoyment of Life||0.38|-0.96|.390
71868255|NCT01237587|143253569|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.424||0.16|TWO_SIDED|95.0|-1.44|0.24|||Mixed Models Analysis|||School Work||0.24|-1.44|.160
71868256|NCT01237587|143253571|SUPERIORITY|||||||0.051|||||||Fisher Exact|||||||.051
71868257|NCT01237587|143253572|SUPERIORITY|||||||0.038|||||||Fisher Exact|||||||.038
71868258|NCT01237587|143253573|SUPERIORITY||Mean Difference (Final Values)|1.62||||0.669|TWO_SIDED|95.0|-9.1|5.86|||ANCOVA|||Average Pain Score||5.86|-9.10|.669
71868259|NCT01237587|143253573|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.169|TWO_SIDED|95.0|-14.32|2.53|||ANCOVA|||Worst Pain Score||2.53|-14.32|.169
71868260|NCT01237587|143253573|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.647|TWO_SIDED|95.0|-9.53|5.94|||ANCOVA|||Pain Score Right Now||5.94|-9.53|.647
71868261|NCT01237587|143253574|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.146|TWO_SIDED|95.0|-0.52|0.08|||ANCOVA|||||0.08|-0.52|.146
71868262|NCT01237587|143253575|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.927|TWO_SIDED|95.0|-0.23|0.21|||ANCOVA|||||0.21|-0.23|.927
71868263|NCT01237587|143253576|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.431|TWO_SIDED|95.0|-1.54|3.59|||ANCOVA|||||3.59|-1.54|.431
71868264|NCT01237587|143253577|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.529|TWO_SIDED|95.0|-1.95|3.79|||ANCOVA|||||3.79|-1.95|.529
71868265|NCT01237587|143253578|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.335|TWO_SIDED|95.0|-2.52|0.86|||ANCOVA|||||0.86|-2.52|.335
71868266|NCT01237587|143253579|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.955|TWO_SIDED|95.0|-1.59|1.68|||ANCOVA|||Physical Symptoms Score||1.68|-1.59|.955
71868267|NCT01237587|143253579|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.381|TWO_SIDED|95.0|-1.82|0.7|||ANCOVA|||Harm Avoidance||0.70|-1.82|.381
71868268|NCT01237587|143253579|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.486|TWO_SIDED|95.0|-1.66|0.79|||ANCOVA|||Social Anxiety||0.79|-1.66|.486
71868269|NCT01237587|143253579|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.7|TWO_SIDED|95.0|-1.17|0.79|||ANCOVA|||Separation/Panic||0.79|-1.17|.700
71868270|NCT01237587|143253579|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.54|TWO_SIDED|95.0|-5.12|2.69|||ANCOVA|||Total Score||2.69|-5.12|.540
71868271|NCT02656329|143253588|NON_INFERIORITY|Non-inferiority of AdreView™ group over SoC group was demonstrated if upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) (AdreView™ group / SoC) was equal to 1.20.|Hazard Ratio (HR)|1.047||||0.8459|TWO_SIDED|95.0|0.295|3.719||Threshold for significance at 0.025 level.|Log Rank||AdreView™ vs. Standard of Care|Analysis was performed using the Cox proportional hazards model stratified by country, with method of treatment guidance (SoC vs AdreView™ group) as the only covariate.||3.719|0.295|0.8459
71868272|NCT01139580|143253597|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71868273|NCT01139580|143253600|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71868274|NCT00633880|143253611|SUPERIORITY_OR_OTHER|||||||0.509||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the primary endpoint was not positive, statistical analysis was not performed on secondary endpoints.|Wilcoxon (Mann-Whitney)|||||||0.509
71868275|NCT00633880|143253616|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71868276|NCT03208036|143253622|SUPERIORITY||||||=|0.69|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .69
71868277|NCT03208036|143253622|SUPERIORITY||||||=|0.74|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .74
71868278|NCT03208036|143253623|SUPERIORITY||||||=|0.62|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .62
71868279|NCT03208036|143253623|SUPERIORITY||||||=|0.24|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .24
71868280|NCT03208036|143253624|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
71868281|NCT03208036|143253624|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
71868282|NCT03208036|143253624|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
71868283|NCT03208036|143253624|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
71868284|NCT03208036|143253624|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
71868285|NCT03208036|143253624|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5 month assessment.||||= .46
71868286|NCT03208036|143253625|SUPERIORITY||||||=|0.68|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .68
71868287|NCT03208036|143253625|SUPERIORITY||||||=|0.45|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .45
71912880|NCT01576406|143345679|SUPERIORITY||Percentage of ratio of geometric mean|108.43|||||TWO_SIDED|90.0|63.47|185.26||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||185.26|63.47|
71912881|NCT01576406|143345679|SUPERIORITY||Percentage of ratio of geometric mean|202.89|||||TWO_SIDED|90.0|120.96|340.3||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||340.30|120.96|
71912882|NCT01576406|143345679|SUPERIORITY||Percentage of ratio of geometric mean|130.78|||||TWO_SIDED|90.0|86.61|197.47||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||197.47|86.61|
71868288|NCT03208036|143253626|SUPERIORITY||||||=|0.81|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .81
71868289|NCT03208036|143253626|SUPERIORITY||||||=|0.31|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .31
71868290|NCT03208036|143253627|SUPERIORITY||||||=|0.79|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .79
71868291|NCT03208036|143253627|SUPERIORITY||||||=|0.5|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .50
71868292|NCT03208036|143253628|SUPERIORITY||||||=|0.47|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .47
71868293|NCT03208036|143253628|SUPERIORITY||||||=|0.09|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .09
71868294|NCT03208036|143253628|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .02
71868295|NCT03208036|143253628|SUPERIORITY||||||=|0.48|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .48
71868296|NCT03208036|143253628|SUPERIORITY||||||=|0.66|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .66
71912883|NCT01576406|143345679|SUPERIORITY||Percentage of ratio of geometric mean|62.82|||||TWO_SIDED|90.0|42.54|92.78||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.||92.78|42.54|
71912884|NCT01962688|143345694|OTHER|||||||0.002|||||||Chi-squared|||||||0.002
71912885|NCT00669032|143345698|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|ONE_SIDED||||||Chi-squared|||||||0.004
71912886|NCT00669032|143345699|SUPERIORITY_OR_OTHER_LEGACY|||||||0.525|TWO_SIDED||||||Chi-squared|||||||0.525
71912887|NCT00669032|143345700|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||Chi-squared|||||||0.030
71912888|NCT00669032|143345701|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
71912889|NCT00669032|143345702|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|TWO_SIDED||||||Chi-squared|||||||0.049
71868297|NCT03208036|143253628|SUPERIORITY||||||=|0.46|||||||t-test, 2 sided|||Within group change assessed between baseline and the 5.5 month assessment.||||= .46
71868298|NCT03208036|143253629|SUPERIORITY||||||=|0.99|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .99
71868299|NCT03208036|143253629|SUPERIORITY||||||=|0.84|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .84
71868300|NCT03208036|143253630|SUPERIORITY||||||=|0.25|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .25
71868301|NCT03208036|143253630|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
71868302|NCT03208036|143253630|SUPERIORITY||||||=|0.14|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .14
71868303|NCT03208036|143253630|SUPERIORITY||||||=|0.02|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .02
71868304|NCT03208036|143253630|SUPERIORITY||||||=|0.24|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .24
71868305|NCT03208036|143253630|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .93
71868306|NCT03208036|143253631|SUPERIORITY||||||=|0.98|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Group x Time interaction.||||= .98
71912890|NCT00669032|143345703|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
71912891|NCT00669032|143345704|SUPERIORITY_OR_OTHER_LEGACY|||||||0.021|TWO_SIDED||||||Chi-squared|||||||0.021
71912892|NCT00669032|143345705|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025|TWO_SIDED||||||Chi-squared|||||||0.025
71912893|NCT00669032|143345706|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||Chi-squared|||||||0.023
71912894|NCT00669032|143345707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Chi-squared|||||||0.002
71912895|NCT00669032|143345708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9129|TWO_SIDED||||||Chi-squared|||||||0.9129
71912896|NCT03627494|143345764|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.03|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.03|0.84|
71912897|NCT03627494|143345765|OTHER||Ratio|0.93|||||TWO_SIDED|90.0|0.84|1.04|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.04|0.84|
71912898|NCT03627494|143345766|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.79|1.01|||||"Analysis was performed using Mixed Effect Model with treatment and period as fixed effect and participant as random effect. Variance Components covariance structure was used."|||1.01|0.79|
71912899|NCT03906136|143345784|SUPERIORITY||Odds Ratio (OR)|0.69||||0.119|TWO_SIDED|95.0|0.43|1.1|||Regression, Logistic|||Week 24||1.10|0.43|0.119
71912900|NCT03906136|143345785|SUPERIORITY||Odds Ratio (OR)|0.59||||0.029|TWO_SIDED|95.0|0.37|0.95|||Regression, Logistic|||Week 12||0.95|0.37|0.029
71868307|NCT03208036|143253631|SUPERIORITY||||||=|0.08|||||||Mixed Models Analysis|||Mixed effect, repeated measure ANOVA to assess change between baseline, 4-month, and 5.5 month assessments. Test for a Main Effect of Time.||||= .08
71868308|NCT03208036|143253631|SUPERIORITY||||||=|0.08|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .08
71868309|NCT03208036|143253631|SUPERIORITY||||||=|0.06|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .06
71868310|NCT03208036|143253631|SUPERIORITY||||||=|0.28|||||||t-test, 2 sided|||Within group change assessed between baseline and 4-month assessment.||||= .28
71868311|NCT03208036|143253631|SUPERIORITY||||||=|0.23|||||||t-test, 2 sided|||Within group change assessed between baseline and 5.5-month assessment.||||= .23
71868312|NCT00515853|143253649|SUPERIORITY|||||||0.54|||||||Regression, Linear|||CCI final||||0.54
71868313|NCT02217501|143253665|SUPERIORITY|||||||0.6595||||||Alpha of 0.05|Cochran-Mantel-Haenszel|||||||0.6595
71868314|NCT05121246|143253666|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
71868315|NCT05121246|143253667|EQUIVALENCE|CI 90% of least squares geometric means must be entirely contained within the range \[80%-125%\].||||||||||||||||PK parameters will be determined using a non-compartmental analysis method. Bioequivalence between MB05 and EU-Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be established by analysis of variance for the PK parameters AUC0-inf, and Cmax.|PK parameters for each participant will be listed and summarised by treatment using descriptive statistics.|||
71868316|NCT00435591|143253689|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.23|||||TWO_SIDED|95.0|-0.37|0.83||||||"Aggregated data were used to determine differences between groups. Statistical analysis is relevant to the aggregated data of all rows except the no assessment row."||0.83|-0.37|
71868317|NCT02245737|143253695|SUPERIORITY||LS Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.77||0.232|TWO_SIDED|95.0|-2.447|0.594|||Mixed Models Analysis|||||0.594|-2.447|0.232
71868318|NCT02245737|143253695|SUPERIORITY||LS Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.78||0.599|TWO_SIDED|95.0|-1.124|1.947|||Mixed Models Analysis|||||1.947|-1.124|0.599
71868319|NCT02245737|143253696|SUPERIORITY||LS Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.83||0.971|TWO_SIDED|95.0|-1.609|1.669|||Mixed Models Analysis|||||1.669|-1.609|0.971
71868320|NCT02245737|143253696|SUPERIORITY||LS Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.85||0.923|TWO_SIDED|95.0|-1.58|1.743|||Mixed Models Analysis|||||1.743|-1.580|0.923
71868321|NCT02245737|143253697|SUPERIORITY||LS Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.53||0.796|TWO_SIDED|95.0|-1.172|0.899|||Mixed Models Analysis|||||0.899|-1.172|0.796
71868322|NCT02245737|143253697|SUPERIORITY||LS Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.53||0.252|TWO_SIDED|95.0|-0.437|1.66|||Mixed Models Analysis|||||1.660|-0.437|0.252
71868323|NCT02245737|143253698|SUPERIORITY||LS Mean Difference (Final Values)|1.11|STANDARD_ERROR_OF_MEAN|1.4||0.428|TWO_SIDED|95.0|-1.637|3.852|||Mixed Models Analysis|||||3.852|-1.637|0.428
71868324|NCT02245737|143253698|SUPERIORITY||LS Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|1.42||0.926|TWO_SIDED|95.0|-2.918|2.655|||Mixed Models Analysis|||||2.655|-2.918|0.926
71868325|NCT02245737|143253699|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.533|TWO_SIDED|95.0|-0.322|0.622|||Mixed Models Analysis|||||0.622|-0.322|0.533
71868326|NCT02245737|143253699|SUPERIORITY||LS Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.24||0.537|TWO_SIDED|95.0|-0.328|0.63|||Mixed Models Analysis|||||0.630|-0.328|0.537
71868327|NCT02245737|143253701|SUPERIORITY||LS Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|1.13||0.116|TWO_SIDED|95.0|-0.441|3.986|||Mixed Models Analysis|||||3.986|-0.441|0.116
71868328|NCT02245737|143253701|SUPERIORITY||LS Mean Difference (Final Values)|1.45|STANDARD_ERROR_OF_MEAN|1.15||0.208|TWO_SIDED|95.0|-0.808|3.704|||Mixed Models Analysis|||||3.704|-0.808|0.208
71868329|NCT02245737|143253702|SUPERIORITY||LS Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.36||0.379|TWO_SIDED|95.0|-0.391|1.027|||Mixed Models Analysis|||||1.027|-0.391|0.379
71868330|NCT02245737|143253702|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.37||0.992|TWO_SIDED|95.0|-0.714|0.721|||Mixed Models Analysis|||||0.721|-0.714|0.992
71868331|NCT02245737|143253703|SUPERIORITY||LS Mean Difference (Final Values)|-51.27|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-56.963|-45.578|||ANCOVA|||||-45.578|-56.963|<0.001
71868332|NCT02245737|143253703|SUPERIORITY||LS Mean Difference (Final Values)|-65.48|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-70.947|-60.022|||ANCOVA|||||-60.022|-70.947|<0.001
71868333|NCT02245737|143253704|SUPERIORITY||LS Mean Difference (Final Values)|-57.99|STANDARD_ERROR_OF_MEAN|2.47|<|0.001|TWO_SIDED|95.0|-62.865|-53.108|||ANCOVA|||||-53.108|-62.865|<0.001
71868334|NCT02245737|143253704|SUPERIORITY||LS Mean Difference (Final Values)|-73.25|STANDARD_ERROR_OF_MEAN|2.37|<|0.001|TWO_SIDED|95.0|-77.926|-68.575|||ANCOVA|||||-68.575|-77.926|<0.001
71868335|NCT02245737|143253705|SUPERIORITY||LS Mean Difference (Final Values)|-19.87|STANDARD_ERROR_OF_MEAN|11.33||0.081|TWO_SIDED|95.0|-42.21|2.464|||ANCOVA|||||2.464|-42.210|0.081
71868336|NCT02245737|143253705|SUPERIORITY||LS Mean Difference (Final Values)|-15.31|STANDARD_ERROR_OF_MEAN|10.78||0.157|TWO_SIDED|95.0|-36.555|5.938|||ANCOVA|||||5.938|-36.555|0.157
71868337|NCT02245737|143253706|SUPERIORITY||LS Mean Difference (Final Values)|-2.62|STANDARD_ERROR_OF_MEAN|1.33||0.05|TWO_SIDED|95.0|-5.243|-0.002|||ANCOVA|||||-0.002|-5.243|0.050
71868338|NCT02245737|143253706|SUPERIORITY||LS Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|1.27||0.095|TWO_SIDED|95.0|-4.618|0.373|||ANCOVA|||||0.373|-4.618|0.095
71868339|NCT02245737|143253707|SUPERIORITY||LS Mean Difference (Final Values)|-13.68|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-18.785|-8.574|||ANCOVA|||||-8.574|-18.785|<0.001
71868340|NCT02245737|143253707|SUPERIORITY||LS Mean Difference (Final Values)|-17.66|STANDARD_ERROR_OF_MEAN|2.66|<|0.001|TWO_SIDED|95.0|-22.887|-12.428|||ANCOVA|||||-12.428|-22.887|<0.001
71868341|NCT02245737|143253708|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.426|TWO_SIDED|95.0|-0.033|0.014|||ANCOVA|||||0.014|-0.033|0.426
71682910|NCT01253174|142883875|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.19||||||90.0|99.18|113.68||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||113.68|99.18|
71868342|NCT02245737|143253708|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.66|TWO_SIDED|95.0|-0.029|0.018|||ANCOVA|||||0.018|-0.029|0.660
71868343|NCT02245737|143253709|SUPERIORITY||LS Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.21|TWO_SIDED|95.0|-0.015|0.003|||ANCOVA|||||0.003|-0.015|0.210
71868344|NCT02245737|143253709|SUPERIORITY||LS Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.568|TWO_SIDED|95.0|-0.013|0.007|||ANCOVA|||||0.007|-0.013|0.568
71868345|NCT02245737|143253710|SUPERIORITY||LS Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|-3.258|-1.413|||ANCOVA|||||-1.413|-3.258|<0.001
71868346|NCT02245737|143253710|SUPERIORITY||LS Mean Difference (Final Values)|-3.18|STANDARD_ERROR_OF_MEAN|0.48|<|0.001|TWO_SIDED|95.0|-4.118|-2.247|||ANCOVA|||||-2.247|-4.118|<0.001
71868347|NCT00618618|143253715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.2|-1.0|0.005
71868348|NCT00618618|143253715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.001|TWO_SIDED|95.0|-1.4|-0.4|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||-0.4|-1.4|0.001
71868349|NCT00618618|143253715|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.069|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||0.0|-0.8|0.069
71868350|NCT00618618|143253716|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.005|TWO_SIDED|95.0|0.6|3.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||3.0|0.6|0.005
71868351|NCT00618618|143253716|SUPERIORITY_OR_OTHER||LS Mean Difference|2.5||||0.001|TWO_SIDED|95.0|1.0|4.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.0|1.0|0.001
71868352|NCT00618618|143253716|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0||||0.122|TWO_SIDED|95.0|-0.3|2.2|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||2.2|-0.3|0.122
71868353|NCT00618618|143253717|SUPERIORITY_OR_OTHER||Difference from Placebo|38.3||||0.008|TWO_SIDED|95.0|11.0|65.7|||Fisher Exact|||||65.7|11.0|0.008
71868354|NCT00618618|143253717|SUPERIORITY_OR_OTHER||Difference from Placebo|32.9||||0.172|TWO_SIDED|95.0|1.0|64.8|||Fisher Exact|||||64.8|1.0|0.172
71868355|NCT00618618|143253717|SUPERIORITY_OR_OTHER||Difference from Placebo|22.9||||0.252|TWO_SIDED|95.0|-8.4|54.2|||Fisher Exact|||||54.2|-8.4|0.252
71868356|NCT00618618|143253718|SUPERIORITY_OR_OTHER||Difference from Placebo|46.1||||0.011|TWO_SIDED|95.0|16.3|75.9|||Fisher Exact|||||75.9|16.3|0.011
71868357|NCT00618618|143253718|SUPERIORITY_OR_OTHER||Difference from Placebo|54.3||||0.013|TWO_SIDED|95.0|23.0|85.5|||Fisher Exact|||||85.5|23.0|0.013
71868358|NCT00618618|143253718|SUPERIORITY_OR_OTHER||Difference from Placebo|24.3||||0.296|TWO_SIDED|95.0|-8.7|57.3|||Fisher Exact|||||57.3|-8.7|0.296
71868359|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.46|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.5|0.460
71868360|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.906|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.5|0.906
71868361|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.404|TWO_SIDED|95.0|-0.6|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.6|0.404
71912901|NCT03906136|143345786|SUPERIORITY||Odds Ratio (OR)|0.71||||0.154|TWO_SIDED|95.0|0.45|1.14|||Regression, Logistic|||Week 12||1.14|0.45|0.154
71912902|NCT03906136|143345786|SUPERIORITY||Odds Ratio (OR)|0.87||||0.562|TWO_SIDED|95.0|0.54|1.39|||Regression, Logistic|||Week 24||1.39|0.54|0.562
71912903|NCT03906136|143345787|SUPERIORITY||Odds Ratio (OR)|0.55||||0.029|TWO_SIDED|95.0|0.32|0.94|||Regression, Logistic|||Week 12||0.94|0.32|0.029
71868362|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.791|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.3|-0.5|0.791
71868363|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.41|TWO_SIDED|95.0|-0.3|0.6|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.6|-0.3|0.410
71868364|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.733|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.5|-0.3|0.733
71868365|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.542|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.3|0.542
71912904|NCT03906136|143345787|SUPERIORITY||Odds Ratio (OR)|0.74||||0.264|TWO_SIDED|95.0|0.44|1.25|||Regression, Logistic|||Week 24||1.25|0.44|0.264
71912905|NCT03906136|143345788|SUPERIORITY||Odds Ratio (OR)|0.49||||0.008|TWO_SIDED|95.0|0.29|0.83|||Regression, Logistic|||Week 12||0.83|0.29|0.008
71912906|NCT03906136|143345788|SUPERIORITY||Odds Ratio (OR)|0.47||||0.005|TWO_SIDED|95.0|0.28|0.8|||Regression, Logistic|||Week 24||0.80|0.28|0.005
71868366|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.882|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.5|-0.4|0.882
71868367|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.4|-0.4|0.934
71868368|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.838|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.4|0.838
71868369|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.777|TWO_SIDED|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.4|-0.5|0.777
71868370|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.795|TWO_SIDED|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.5|-0.4|0.795
71868371|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS mean Difference|0.0||||0.852|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.4|-0.4|0.852
71868372|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.444|TWO_SIDED|95.0|-0.6|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.3|-0.6|0.444
71868373|NCT00618618|143253719|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.724|TWO_SIDED|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||0.5|-0.3|0.724
71868374|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.934|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.4|-0.4|0.934
71868375|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.286|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.2|-0.7|0.286
71912907|NCT03906136|143345789|SUPERIORITY||Odds Ratio (OR)|0.72||||0.263|TWO_SIDED|95.0|0.4|1.28|||Regression, Logistic|||Week 12||1.28|0.40|0.263
71912908|NCT03906136|143345789|SUPERIORITY||Odds Ratio (OR)|0.61||||0.103|TWO_SIDED|95.0|0.34|1.1|||Regression, Logistic|||Week 24||1.10|0.34|0.103
71912909|NCT03906136|143345790|SUPERIORITY||Odds Ratio (OR)|0.64||||0.055|TWO_SIDED|95.0|0.4|1.01|||Regression, Logistic|||Week 12||1.01|0.40|0.055
71912910|NCT03906136|143345790|SUPERIORITY||Odds Ratio (OR)|0.82||||0.409|TWO_SIDED|95.0|0.52|1.31|||Regression, Logistic|||Week 24||1.31|0.52|0.409
71912911|NCT03906136|143345791|SUPERIORITY||Odds Ratio (OR)|0.85||||0.477|TWO_SIDED|95.0|0.53|1.34|||Regression, Logistic|||Week 12||1.34|0.53|0.477
71912912|NCT03906136|143345791|SUPERIORITY||Odds Ratio (OR)|1.01||||0.968|TWO_SIDED|95.0|0.63|1.61|||Regression, Logistic|||Week 24||1.61|0.63|0.968
71868376|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.19|TWO_SIDED|95.0|-0.1|0.7|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4||0.7|-0.1|0.190
71868377|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.402|TWO_SIDED|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.5|0.402
71868378|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.29|TWO_SIDED|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.2|-0.7|0.290
71868379|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8||0.4|-0.4|0.863
71868380|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.128|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.1|-0.7|0.128
71868381|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.018|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||-0.1|-0.9|0.018
71868382|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.489|TWO_SIDED|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12||0.3|-0.5|0.489
71912913|NCT03906136|143345792|SUPERIORITY||Odds Ratio (OR)|0.3||||0.205|TWO_SIDED|95.0|-0.16|0.75|||Regression, Logistic|||Week 12||0.75|-0.16|0.205
71912914|NCT03906136|143345792|SUPERIORITY||Odds Ratio (OR)|0.37||||0.108|TWO_SIDED|95.0|-0.08|0.82|||Regression, Logistic|||Week 24||0.82|-0.08|0.108
71912915|NCT03906136|143345793|SUPERIORITY||Mean Difference (Net)|0.06||||0.525|TWO_SIDED|95.0|-0.12|0.23|||Mixed Models Analysis|||Week 12||0.23|-0.12|0.525
71912916|NCT03906136|143345793|SUPERIORITY||Mean Difference (Net)|-0.06||||0.577|TWO_SIDED|95.0|-0.25|0.14|||Mixed Models Analysis|||Week 24||0.14|-0.25|0.577
71912917|NCT03906136|143345794|SUPERIORITY||Odds Ratio (OR)|-0.89||||0.22|TWO_SIDED|95.0|-2.32|0.54|||Mixed Models Analysis|||Week 12||0.54|-2.32|0.220
71912918|NCT03906136|143345794|SUPERIORITY||Median Difference (Net)|-0.1||||0.745|TWO_SIDED|95.0|-0.7|0.5|||Regression, Logistic|||Week 24||0.50|-0.70|0.745
71912919|NCT03906136|143345795|SUPERIORITY||Mean Difference (Net)|-0.13||||0.768|TWO_SIDED|95.0|-1.01|0.74|||Mixed Models Analysis|||Week 12||0.74|-1.01|0.768
71912920|NCT03906136|143345795|SUPERIORITY||Mean Difference (Net)|-0.37||||0.451|TWO_SIDED|95.0|-1.34|0.6|||Mixed Models Analysis|||Week 24||0.60|-1.34|0.451
71682911|NCT01253174|142883876|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|97.98||||||90.0|94.19|101.93||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.93|94.19|
71682912|NCT01253174|142883877|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|104.9||||||90.0|98.83|111.34||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||111.34|98.83|
71682913|NCT01253174|142883878|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.63||||||90.0|95.73|103.69||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Metafolin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||103.69|95.73|
71682914|NCT01253174|142883880|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.57||||||90.0|97.32|101.87||The equivalence test was done using a 90% confidence interval, no p-value was to be calculated.|ANOVA||Point estimate for the ratio \[(EE30/DRSP/L-5-MTHF Ca) / Yasmin\]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis||101.87|97.32|
71682915|NCT02892513|142883885|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71682916|NCT02407054|142883888|SUPERIORITY||Hazard Ratio (HR)|0.5871|||||TWO_SIDED|95.0|0.3967|0.869||||||||0.8690|0.3967|
71682917|NCT02407054|142883889|SUPERIORITY||Hazard Ratio (HR)|0.6515|||||TWO_SIDED|95.0|0.4123|1.0294||||||||1.0294|0.4123|
71868383|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.007|TWO_SIDED|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.1|-0.9|0.007
71682918|NCT02044874|142883900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.0027|TWO_SIDED|95.0|1.47|6.22|||Regression, Logistic|||||6.22|1.47|0.0027
71868384|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.3|-0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||-0.4|-1.3|<0.001
71868385|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.122|TWO_SIDED|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16||0.1|-0.7|0.122
71868386|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.005|TWO_SIDED|95.0|-0.9|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-0.9|0.005
71868387|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.3|-1.2|<0.001
71868388|NCT00618618|143253720|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.007|TWO_SIDED|95.0|-1.0|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24||-0.2|-1.0|0.007
71868389|NCT00618618|143253722|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9||||0.573|TWO_SIDED|95.0|-8.6|4.8|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||4.8|-8.6|0.573
71912921|NCT03906136|143345796|SUPERIORITY||Mean Difference (Net)|0.26||||0.477|TWO_SIDED|95.0|-0.46|0.97|||Mixed Models Analysis|||Week 12||0.97|-0.46|0.477
71682919|NCT02044874|142883900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.2427|TWO_SIDED|95.0|0.73|3.51|||Regression, Logistic|||||3.51|0.73|0.2427
71682920|NCT02044874|142883900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.0477|TWO_SIDED|95.0|1.01|3.56|||Regression, Logistic|||||3.56|1.01|0.0477
71682921|NCT02044874|142883901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84||||0.0784|TWO_SIDED|95.0|0.89|9.08|||Regression, Logistic|||||9.08|0.89|0.0784
71682922|NCT02044874|142883901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.365|TWO_SIDED|95.0|0.51|6.17|||Regression, Logistic|||||6.17|0.51|0.3650
71868390|NCT00618618|143253722|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8||||0.653|TWO_SIDED|95.0|-6.3|9.9|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||9.9|-6.3|0.653
71868391|NCT00618618|143253722|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.688|TWO_SIDED|95.0|-5.4|8.1|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.||||8.1|-5.4|0.688
71912922|NCT03906136|143345796|SUPERIORITY||Mean Difference (Net)|-0.17||||0.66|TWO_SIDED|95.0|-0.92|0.58|||Mixed Models Analysis|||Week 24||0.58|-0.92|0.660
71682923|NCT02044874|142883901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.3438|TWO_SIDED|95.0|0.61|4.21|||Regression, Logistic|||||4.21|0.61|0.3438
71682924|NCT02044874|142883902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0379|TWO_SIDED|95.0|1.04|3.55|||Regression, Logistic|||||3.55|1.04|0.0379
71682925|NCT02044874|142883902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8628|TWO_SIDED|95.0|0.54|2.09|||Regression, Logistic|||||2.09|0.54|0.8628
71682926|NCT02044874|142883902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0556|TWO_SIDED|95.0|0.99|3.31|||Regression, Logistic|||||3.31|0.99|0.0556
71682927|NCT02044874|142883903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92||||0.0219|TWO_SIDED|95.0|1.1|3.35|||Regression, Logistic|||||3.35|1.10|0.0219
71682928|NCT02044874|142883903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.545|TWO_SIDED|95.0|0.66|2.18|||Regression, Logistic|||||2.18|0.66|0.5450
71682929|NCT02044874|142883903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.0868|TWO_SIDED|95.0|0.93|2.72|||Regression, Logistic|||||2.72|0.93|0.0868
71682930|NCT02044874|142883904|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.97||||0.0004|TWO_SIDED|95.0|-1.51|-0.43|||Mixed-effects repeated measures|||||-0.43|-1.51|0.0004
71682931|NCT02044874|142883904|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.34||||0.2268|TWO_SIDED|95.0|-0.89|0.21|||mixed effects repeated measures|||||0.21|-0.89|0.2268
71682932|NCT02044874|142883904|SUPERIORITY_OR_OTHER||Difference in LS Means|-0.63||||0.0217|TWO_SIDED|95.0|-1.17|-0.09|||mixed effects repeated measures|||||-0.09|-1.17|0.0217
71682933|NCT00415597|142883906|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
71912923|NCT03906136|143345797|SUPERIORITY||Mean Difference (Net)|0.17||||0.586|TWO_SIDED|95.0|-0.45|0.79|||Mixed Models Analysis|||Week 12||0.79|-0.45|0.586
71912924|NCT03906136|143345797|SUPERIORITY||Median Difference (Net)|0.21||||0.491|TWO_SIDED|95.0|-0.39|0.82|||Mixed Models Analysis|||Week 24||0.82|-0.39|0.491
71912925|NCT03906136|143345798|SUPERIORITY|Week 12|Mean Difference (Net)|4.49||||0.082|TWO_SIDED|95.0|-0.58|9.56|||Mixed Models Analysis|||||9.56|-0.58|0.082
71912926|NCT03906136|143345798|SUPERIORITY||Median Difference (Net)|2.73||||0.292|TWO_SIDED|95.0|-2.35|7.81|||Mixed Models Analysis|||Week 24||7.81|-2.35|0.292
71912927|NCT00323310|143345809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.46|<|0.0001|TWO_SIDED|95.0|1.1|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.1|<0.0001
71912928|NCT00323310|143345810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.45|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
71912929|NCT00323310|143345811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_DEVIATION|1.42|<|0.0001|TWO_SIDED|95.0|0.4|0.9||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.9|0.4|<0.0001
71912930|NCT00323310|143345812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|1.56|<|0.001|TWO_SIDED|95.0|1.1|1.6||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.6|1.1|<0.001
71912931|NCT00323310|143345813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|1.49|<|0.001|TWO_SIDED|95.0|0.8|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.8|<0.001
71912932|NCT00323310|143345814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|1.2|<|0.0001|TWO_SIDED|95.0|0.4|0.8||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||0.8|0.4|<0.0001
71912933|NCT00323310|143345815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.57|<|0.0001|TWO_SIDED|95.0|1.0|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.5|1.0|<0.0001
71912934|NCT00323310|143345816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.49|<|0.0001|TWO_SIDED|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.4|0.9|<0.0001
71912935|NCT00323310|143345817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|1.54|<|0.0001|TWO_SIDED|95.0|0.6|1.1||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose||1.1|0.6|<0.0001
71912936|NCT00446641|143345874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.654||95.0|||||Chi-squared|||We assumed that the prevalence of AR would be 12 % among ischemic stroke patients who were treated with aspirin 100 per day. The prevalence could be reduced to 4% with additional cilostazol therapy||||0.654
71912937|NCT02971007|143345931|OTHER|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.||||||||||||||||No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.|||
71912938|NCT02707601|143345954|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
71912939|NCT02707601|143345954|SUPERIORITY|||||||0.042||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.042
71912940|NCT02707601|143345955|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
71912941|NCT02707601|143345955|SUPERIORITY|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test|||||||0.002
71912942|NCT02707601|143345956|OTHER||Difference in Percentages|0.0||||1|TWO_SIDED|95.0|-6.1|6.1|||Fisher exact test||The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||6.1|-6.1|1.00
71868392|NCT02929329|143253724|SUPERIORITY|"The overall type I error was 0.05 for 2-sided testing across primary and secondary outcomes.~Control for multiple comparisons was achieved using the following testing algorithm: if the primary outcome met the P-value threshold of 0.05, the alpha error would be divided unequally between cardiovascular death (96% of the overall alpha error, or 0.048) and change from baseline to week 24 in the Kansas City Cardiomyopathy Questionnaire total symptom score (4% of the overall alpha error, or 0.002)."|Hazard Ratio (HR)|0.92||||0.0252|TWO_SIDED|95.0|0.86|0.99|||Regression, Cox|Stratified by randomization setting and region, including terms for baseline estimated glomerular filtration rate (eGFR) and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||0.99|0.86|0.0252
71868393|NCT02929329|143253724|SUPERIORITY|||||||0.0211|||||||Stratified log-rank test|Log-rank test stratified by randomization setting and region.||||||0.0211
71868394|NCT02929329|143253724|SUPERIORITY||Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.86|0.99|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||0.99|0.86|
71868395|NCT02929329|143253725|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8555|TWO_SIDED|95.0|0.92|1.11||If significance for the primary outcome was determined, cardiovascular death was tested against an alpha of 0.048.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|||1.11|0.92|0.8555
71868396|NCT02929329|143253725|SUPERIORITY||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.11|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the treatment group and baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint were considered as the competing risk.||1.11|0.92|
71868397|NCT02929329|143253726|OTHER||Least Squares (LS) Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|95.0|-1.4|0.48|||||Treatment difference = Omecamtiv mecarbil - Placebo|||0.48|-1.40|
71868398|NCT02929329|143253726|OTHER||LS Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|95.0|0.54|4.46|||||Treatment difference = Omecamtiv mecarbil - Placebo|||4.46|0.54|
71868399|NCT02929329|143253726|SUPERIORITY|If significance for the primary outcome was determined, change from baseline in the KCCQ total symptom score was tested against an alpha of 0.002.||||||0.0278|||||||Omnibus F-test|||||||0.0278
71868400|NCT02929329|143253726|OTHER||Pooled treatment difference|0.75|||||TWO_SIDED|95.0|-2.55|4.51|||||Overall pooled estimate of treatment difference (Omecamtiv mecarbil - Placebo) using random effects meta-analysis approach.|||4.51|-2.55|
71868401|NCT02929329|143253726|SUPERIORITY||LS Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.62|0.2|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||0.20|-1.62|
71868402|NCT02929329|143253726|SUPERIORITY||LS mean difference|2.31|||||TWO_SIDED|95.0|0.8|3.82|||||Treatment difference = Omecamtiv mecarbil - Placebo|As a sensitivity for missing data due to death, joint longitudinal and survival models were fit using KCCQ TSS observed values with random subject slopes and intercepts for the longitudinal models with terms for baseline eGFR, region, and treatment by slope. The survival models were fit for all-cause death with baseline eGFR and treatment in the proportional hazard part of the models, KCCQ TSS modeled values as the shared parameterization, stratified by region with Weibull baseline functions.||3.82|0.80|
71868403|NCT02929329|143253727|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.1902|TWO_SIDED|95.0|0.87|1.03||If statistical significance was achieved for both the time to CV death and change from baseline in the KCCQ TSS, time to first heart failure hospitalization was to be tested at the full alpha.|Regression, Cox|Stratified by randomization setting and region, including terms for baseline eGFR and treatment group.|Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.03|0.87|0.1902
71868404|NCT02929329|143253727|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.88|1.04|||||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|Competing risk subdistribution hazard ratio and associated 95% confidence intervals for treatment were computed. Deaths not included in the endpoint are considered as the competing risk.||1.04|0.88|
71868405|NCT02929329|143253728|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9633|TWO_SIDED|95.0|0.92|1.09||If time to first heart failure hospitalization was statistically significant, time to all-cause death was to be tested with the same alpha as time to first heart failure hospitalization.|Regression, Cox||Cox proportional-hazards model with baseline hazards stratified according to the randomization setting and geographic region and with the trial group and the baseline eGFR as covariates.|||1.09|0.92|0.9633
71868406|NCT00560560|143253749|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED|||||The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.|Test of probability of 6 month survival|p-Value \>0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.||The hypotheses for each group were H0:p=0.45 vs H1:p\>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.||||>0.05
71912943|NCT02009930|143345958|OTHER||Wilson Method used|16.0|||||TWO_SIDED|95.0|9.4|22.9||||||||22.9|9.4|
71912944|NCT02009930|143345959|OTHER||||||||||||||||||Only descriptive statistics were calculated (frequency, percent). Inferential statistics were not necessary, nor appropriate|||
71912945|NCT02009930|143345960|OTHER|||||||0.79||||||Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor expressed as a p-value|Spearman's Rank Correlation Coefficient|Correlation between FRS and CAC risk categories in participants with at least 1 additional risk factor. Spearman's rho = 0.04||Compare risk categories (FRS and CAC)||||0.79
71912946|NCT02009930|143345961|OTHER|||||||0.063||||||Relationship between FRS and metabolic syndrome. FRS risk category (low, mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||FRS risk category (low, mod, mod-high, high, very high risk)||||0.063
71912947|NCT02009930|143345961|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
71912948|NCT02009930|143345962|OTHER|||||||0.56||||||Relationship between FRS and living in the dorms. FRS risk category (low, mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||FRS risk categories (low, moderate, mod -high, high, and very high)||||0.56
71912949|NCT02009930|143345962|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
71912950|NCT02009930|143345963|OTHER|||||||0.44||||||Relationship between FRS and PT failures. FRS risk category (low, mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, PT failure - with/without PT failure) expressed as a p-value||FRS risk categories (low, moderate, moderate-high, high, and very high)||||0.44
71912951|NCT02009930|143345963|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
71912952|NCT02009930|143345964|OTHER|||||||0.11||||||Relationship between FRS and overall years of service. FRS risk category (low, mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (FRS - each risk category, overall years of service) expressed as a p-value||FRS risk categories (low, moderate, moderate -high, high, and very high)||||0.11
71682934|NCT00415597|142883907|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0||||<0.0001
71912953|NCT02009930|143345964|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
71912954|NCT02009930|143345966|OTHER|||||||0.21||||||Relationship between CAC and metabolic syndrome. CAC risk category (low, low-mod, mod-high, high, very high risk) and metabolic syndrome (presence/absence of metabolic syndrome)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, metabolic syndrome - presence/absence) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high)||||0.21
71682935|NCT01447927|142883908|SUPERIORITY_OR_OTHER|||||||0.7981|||||||Wilcoxon Rank-Rum Test (1-sided)|||The null hypothesis was that the percent change in mean pS6K1 values (from pre to post) was the same or increased for the metformin arm as compared to placebo. Assuming equal standard deviations (i.e. 50%) across the metformin and placebo groups, 30 participants per arm yielded 84% power to detect at least a 35% decrease in the metformin arm as compared to placebo, using a 1-sided t-test with a significant level of 0.05.||||0.7981
71682936|NCT01650545|142883928|SUPERIORITY|||||||0.03|||||||Log Rank|||||||0.03
71912955|NCT02009930|143345967|OTHER|||||||0.13||||||Relationship between CAC and living in the dorms. CAC risk category (low, low-mod, mod-high, high, very high risk) and living in the dorms (\< 5 years, \> 5 years)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, living in the dorms - \<5 years/\> 5 years) expressed as a p-value||CAC risk category (low, low-mod, moderate - high, high, and very high)||||0.13
71912956|NCT02009930|143345968|OTHER|||||||0.49||||||Relationship between CAC and PT failures. CAC risk category (low, low-mod, mod-high, high, very high risk) and PT failures (with, without PT failure)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, PT failure - with/without PT failure) expressed as a p-value||CAC risk categories (low, low-moderate, mod -high, high, and very high)||||0.49
71912957|NCT02009930|143345969|OTHER|||||||0.003||||||Relationship between CAC and overall years of service. CAC risk category (low, low-mod, mod-high, high, very high risk) and overall years of service (15-19, 20-24, 25+)|Fisher Exact|Relationship between 2 variables (CAC - each risk category, overall years of service) expressed as a p-value||CAC risk category (low, low-mod, mod-high, high, very high risk)||||0.003
71868407|NCT00768079|143253792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
71868408|NCT00768079|143253792|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71868409|NCT00768079|143253792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.312|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.312
71868410|NCT00768079|143253792|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71868411|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
71868412|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71868413|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.343|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.343
71868414|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 4, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71868415|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
71868416|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, non-adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71912958|NCT03300427|143346002|SUPERIORITY||difference in least square means|-900.0||||0.7594|TWO_SIDED|95.0|-6781.7|4981.8|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||4981.8|-6781.7|0.7594
71912959|NCT03300427|143346004|SUPERIORITY||difference in least square means|-575.5||||0.8422|TWO_SIDED|95.0|-6365.5|5214.5|||ANCOVA|||The study hypothesis is that short-term therapy with sacubitril/valsartan added on standard HF therapy improves cardiac efficiency in subjects with systolic HF.||5214.5|-6365.5|0.8422
71682937|NCT01172808|142883961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.236|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.181|0.291|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.291|0.181|<0.0001
71868417|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||0.474|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||0.474
71868418|NCT00768079|143253794|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Fisher Exact|||Week 24, adjudicated exacerbations: Fisher's exact test was used for statistical analysis.||||1.000
71868419|NCT01859988|143253832|SUPERIORITY_OR_OTHER||Least square (LS) mean difference|-55.7|STANDARD_ERROR_OF_MEAN|6.74|<|0.0001|TWO_SIDED|95.0|-68.9|-42.4||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w \& 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.||-42.4|-68.9|<0.0001
71868420|NCT01859988|143253832|SUPERIORITY_OR_OTHER||LS mean difference|-50.1|STANDARD_ERROR_OF_MEAN|6.67|<|0.0001|TWO_SIDED|95.0|-63.3|-37.0||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.0|-63.3|<0.0001
71868421|NCT01859988|143253832|SUPERIORITY_OR_OTHER||LS mean difference|-47.4|STANDARD_ERROR_OF_MEAN|6.76|<|0.0001|TWO_SIDED|95.0|-60.6|-34.1||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 200 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-34.1|-60.6|<0.0001
71868422|NCT01859988|143253832|SUPERIORITY_OR_OTHER||LS mean difference|-45.4|STANDARD_ERROR_OF_MEAN|6.66|<|0.0001|TWO_SIDED|95.0|-58.5|-32.3||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-32.3|-58.5|<0.0001
71868423|NCT01859988|143253832|SUPERIORITY_OR_OTHER||LS mean difference|-26.8|STANDARD_ERROR_OF_MEAN|6.65|<|0.0001|TWO_SIDED|95.0|-39.8|-13.7||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 100 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.7|-39.8|<0.0001
71868424|NCT02081417|143253860|NON_INFERIORITY|Based on the PCL-C if the interventions fell within 2.5 points of each other|Mean Difference (Net)|0.18||||0.01|TWO_SIDED|95.0|-3.4|3.8|||Mixed Models Analysis|||||3.8|-3.4|0.01
71868425|NCT03097484|143253866|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71912960|NCT00671970|143346022|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71912961|NCT00671970|143346023|SUPERIORITY_OR_OTHER|||||||0.613||95.0|||||Fisher Exact|||||||.613
71912962|NCT00671970|143346024|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71912963|NCT00671970|143346025|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71912964|NCT00671970|143346026|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71912965|NCT00671970|143346027|SUPERIORITY_OR_OTHER|||||||0.179||95.0|||||Wilcoxon (Mann-Whitney)|||||||.179
71912966|NCT00671970|143346028|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Wilcoxon (Mann-Whitney)|||||||.008
71682938|NCT01172808|142883961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.142|0.253|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre , week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.253|0.142|<0.0001
71682939|NCT01172808|142883962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.126|0.244|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.244|0.126|<0.0001
71682940|NCT01172808|142883962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.092|0.211|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction.||0.211|0.092|<0.0001
71868426|NCT03097484|143253867|SUPERIORITY|||||||0.05||||||0.05 is the calculated p-value (not the threshold for statistical significance)|t-test, 2 sided|||||||0.05
71868427|NCT00371683|143253937|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% confidence interval (CI) for the Relative Risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Ratio (RR)|1.02||||0.0635|TWO_SIDED|95.0|0.78|1.32||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||1.32|0.78|0.0635
71868428|NCT00371683|143253937|NON_INFERIORITY_OR_EQUIVALENCE|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be \< 1.25, and the upper bound of the 95% CI for the risk difference should be \< 5.6%.|Risk Difference (RD)|0.11|||<|0.0001|TWO_SIDED|95.0|-2.22|2.44||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided|||||2.44|-2.22|<0.0001
71868429|NCT00371683|143253938|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.7|2.23|||||If the upper bound of the two-sided 95% CI for the Relative Risk was \< 1 then superiority for the key secondary efficacy endpoint was demonstrated.|||2.23|0.70|
71868430|NCT00371683|143253938|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.36|||||TWO_SIDED|95.0|-0.68|1.4||||||||1.40|-0.68|
71868431|NCT00371683|143253938|SUPERIORITY_OR_OTHER|||||||0.7779|TWO_SIDED||||||t-test, 1 sided|||||||0.7779
71868432|NCT00371683|143253939|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||||1.35|0.80|
71912967|NCT00633893|143346029|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3283|||<|0.0001|TWO_SIDED|95.0|0.2225|0.4844||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4844|0.2225|<0.0001
71912968|NCT00633893|143346029|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3615|||<|0.0001|TWO_SIDED|95.0|0.2475|0.5281||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.||0.5281|0.2475|<0.0001
71868433|NCT00371683|143253939|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-2.04|2.59||||||||2.59|-2.04|
71868434|NCT00371683|143253939|SUPERIORITY_OR_OTHER|||||||0.7754|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7754
71868435|NCT00371683|143253940|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.41|||||TWO_SIDED|95.0|0.77|2.6||||||||2.60|0.77|
71868436|NCT00371683|143253940|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.53|||||TWO_SIDED|95.0|-0.47|1.52||||||||1.52|-0.47|
71868437|NCT00371683|143253940|SUPERIORITY_OR_OTHER|||||||0.2626|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2626
71868438|NCT00371683|143253941|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.63|1.87||||||||1.87|0.63|
71868439|NCT00371683|143253941|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11|||||TWO_SIDED|95.0|-0.99|1.21||||||||1.21|-0.99|
71868440|NCT00371683|143253941|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.7700
71868441|NCT00371683|143253942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19|||||TWO_SIDED|95.0|0.68|2.11||||||||2.11|0.68|
71868442|NCT00371683|143253942|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.28|||||TWO_SIDED|95.0|-0.78|1.33||||||||1.33|-0.78|
71868443|NCT00371683|143253942|SUPERIORITY_OR_OTHER|||||||0.5443|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||||||0.5443
71868444|NCT00371683|143253943|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.2|4.93||||||||4.93|0.20|
71868445|NCT00371683|143253943|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||||0.30|-0.30|
71868446|NCT00371683|143253943|SUPERIORITY_OR_OTHER|||||||0.9975|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.9975
71682941|NCT01172808|142883963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.114|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.233|0.114|<0.0001
71868447|NCT00371683|143253944|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.05|0.3||||||||0.30|-0.05|
71868448|NCT00371683|143253944|SUPERIORITY_OR_OTHER|||||||0.1578|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.1578
71868449|NCT00371683|143253945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.65|2.4||||||||2.40|0.65|
71868450|NCT00371683|143253945|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.25|||||TWO_SIDED|95.0|-0.47|0.98||||||||0.98|-0.47|
71868451|NCT00371683|143253946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.46|||||TWO_SIDED|95.0|0.72|2.95||||||||2.95|0.72|
71868452|NCT00371683|143253946|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.38|||||TWO_SIDED|95.0|-0.3|1.06||||||||1.06|-0.30|
71868453|NCT00371683|143253946|SUPERIORITY_OR_OTHER|||||||0.2873|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.2873
71868454|NCT00371683|143253947|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.74|1.2||||||||1.20|0.74|
71868455|NCT00371683|143253947|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.83|||||TWO_SIDED|95.0|-3.3|1.63||||||||1.63|-3.30|
71868456|NCT00371683|143253947|SUPERIORITY_OR_OTHER|||||||0.6145|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||||||0.6145
71868457|NCT00371683|143253950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.55|0.05||||||Adjusted difference of event rates of MI/Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.55|
71868458|NCT00371683|143253950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.19|||||TWO_SIDED|95.0|-0.46|0.09||||||Adjusted difference of event rates of MI. Type of surgery was taken into consideration as a stratification factor.||0.09|-0.46|
71868459|NCT00371683|143253950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of Stroke. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
71868460|NCT00371683|143253950|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.13|||||TWO_SIDED|95.0|-0.3|0.05||||||Adjusted difference of event rates of thrombocytopenia. Type of surgery was taken into consideration as a stratification factor.||0.05|-0.30|
71868461|NCT00371683|143253951|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.81|||||TWO_SIDED|95.0|-1.49|-0.14||||||Adjusted difference of event rates of Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.14|-1.49|
71868462|NCT00371683|143253951|SUPERIORITY_OR_OTHER|||||||0.0533|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Major Bleeding Endpoint||||0.0533
71868463|NCT00371683|143253951|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.77|||||TWO_SIDED|95.0|-1.87|0.33||||||Adjusted difference of event rates of Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.33|-1.87|
71868464|NCT00371683|143253951|SUPERIORITY_OR_OTHER|||||||0.1709|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Clinically relevant Non-Major Bleeding endpoint||||0.1709
71868465|NCT00371683|143253951|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.46|||||TWO_SIDED|95.0|-2.75|-0.17||||||Adjusted difference of event rates of Major or Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.||-0.17|-2.75|
71868466|NCT00371683|143253951|SUPERIORITY_OR_OTHER|||||||0.0338|TWO_SIDED||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||Major or Clinically Relevant Non-Major Bleeding endpoint.||||0.0338
71868467|NCT00371683|143253951|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.52|||||TWO_SIDED|95.0|-3.18|0.13||||||Adjusted difference of event rates of Any Bleeding. Type of surgery was taken into consideration as a stratification factor.||0.13|-3.18|
71868468|NCT00371683|143253951|SUPERIORITY_OR_OTHER|||||||0.0816|TWO_SIDED|||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Any Bleeding Endpoint.||||0.0816
71868469|NCT00589121|143253997|SUPERIORITY_OR_OTHER|The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).||||||0.0005|||||||Fisher Exact|||Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.||||0.0005
71868470|NCT03748992|143254013|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||Non Applicable||Non Applicable||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
71868471|NCT03748992|143254015|OTHER|Since no hypothesis testing was planned, no power analysis was required||||||||||||||||This was a single arm trial. there is no comparator group.|The overall response rates were calculated, and exact binomial confidence intervals was constructed.|||
71868472|NCT03924765|143254030|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed by setting an alpha value to 0.05.||||||5e-06|||||||ANOVA|||Primary Outcome Measure - Arm/Group 1||||0.000005
71868473|NCT03924765|143254031|OTHER|A one-way repeated measures analysis of variance (ANOVA) was performed on different exoskeleton assistance strategies (including the baseline of not wearing the exoskeleton) on the subject's step length asymmetry by setting an alpha value to 0.05.||||||0.131|||||||ANOVA|||Secondary Outcome Measure - Arm/Group 1||||0.131
71868474|NCT04548544|143254040|OTHER|||||||0.38|||||||ANOVA|||timepoint × group interaction|timepoint × group interaction F = 0.77, p = 0.38|||0.38
71868475|NCT01370590|143254059|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet was considered equivalent to co-administration of ezetimibe 10 mg and atorvastatin 20 mg, if the two-sided 97.5% expanded confidence intervals of the treatment difference in least squares means for percent change in LDL-C from baseline after 6 weeks of treatment (combination minus co-administration) was contained within -4% and 4% (equivalence margins).|Difference in Least-square Means|-0.2|||||TWO_SIDED|97.5|-1.7|3.3|||ANCOVA|||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.4% and that the standard deviation of the difference is 12.8%.||3.3|-1.7|
71868476|NCT01370590|143254060|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-square means|0.3|||||TWO_SIDED|97.5|-0.8|1.4|||ANCOVA|||||1.4|-0.8|
71868477|NCT01370590|143254061|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-squares mean|0.8|||||TWO_SIDED|97.5|-0.6|2.2|||ANCOVA|||||2.2|-0.6|
71868478|NCT01370590|143254062|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.0|||||TWO_SIDED|97.5|-1.3|1.4|||ANCOVA|||||1.4|-1.3|
71868479|NCT01370590|143254063|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|0.7|||||TWO_SIDED|97.5|-0.6|1.9|||ANCOVA|||||1.9|-0.6|
71868480|NCT01370590|143254064|SUPERIORITY_OR_OTHER_LEGACY||Difference in least-squares means|1.6|||||TWO_SIDED|97.5|-3.2|6.3|||Constrained Longitudinal Data Analysis|||Analyses were based on log-transformed data.||6.3|-3.2|
71868481|NCT05172050|143254065|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|9.99||||0.0109|TWO_SIDED|95.0|1.781||Upper limit is not estimable (NE) due to the low number of events||Regression, Logistic||||||1.781|0.0109
71868482|NCT05172050|143254065|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Odds Ratio (OR)|5.414||||0.0673|TWO_SIDED|95.0|0.858||The upper limit is not estimable (NE), due to the low number of events||Regression, Logistic||||||0.858|0.0673
71868483|NCT05172050|143254065|SUPERIORITY||Odds Ratio (OR)|12.186||||0.0061|TWO_SIDED|95.0|2.147||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm.|||2.147|0.0061
71868484|NCT05172050|143254065|SUPERIORITY||Odds Ratio (OR)|5.936||||0.0567|TWO_SIDED|95.0|0.938||The upper limit was not estimable due to the low number of events|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm|||0.938|0.0567
71868485|NCT05172050|143254066|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|1.663||||0.7121|TWO_SIDED|95.0|0.337|9.053|||Regression, Logistic|||||9.053|0.337|0.7121
71868486|NCT05172050|143254066|SUPERIORITY|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects|Odds Ratio (OR)|0.963|||>|0.999|TWO_SIDED|95.0|0.185|4.977|||Regression, Logistic|||||4.977|0.185|>0.999
71868487|NCT05172050|143254066|SUPERIORITY||Odds Ratio (OR)|2.34||||0.5378|TWO_SIDED|95.0|0.35|20.153||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||20.153|0.350|0.5378
71868488|NCT05172050|143254066|SUPERIORITY||Odds Ratio (OR)|1.209|||>|0.999|TWO_SIDED|95.0|0.185|8.589||Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.|Regression, Logistic|||This sensitivity analysis is conducted on the per protocol (PP) population: n=18 in the Raloxifene 60 mg arm; n=17 in the Raloxifene 120 mg arm; and n=17 in the Placebo arm||8.589|0.185|>0.999
71868489|NCT05172050|143254067|SUPERIORITY||Odds Ratio (OR)|1.114|||>|0.999|TWO_SIDED|95.0|0.219|5.708|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 14||5.708|0.219|>0.999
71868490|NCT05172050|143254067|SUPERIORITY||Odds Ratio (OR)|3.202||||0.2553|TWO_SIDED|95.0|0.541|22.116|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||At day 14||22.116|0.541|0.2553
71868491|NCT05172050|143254067|SUPERIORITY||Odds Ratio (OR)|2.16||||0.6189|TWO_SIDED|95.0|0.294|18.532|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||18.532|0.294|0.6189
71868492|NCT05172050|143254067|SUPERIORITY||Odds Ratio (OR)|7.22||||0.1662|TWO_SIDED|95.0|0.586|413.499|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects.||at Day 28||413.499|0.586|0.1662
71868493|NCT05172050|143254068|SUPERIORITY||Odds Ratio (OR)|0.972|||>|0.999|TWO_SIDED|95.0|0.193|4.906|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||4.906|0.193|>0.999
71868494|NCT05172050|143254068|SUPERIORITY||Odds Ratio (OR)|1.156|||>|0.999|TWO_SIDED|95.0|0.2|6.822|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 7||6.822|0.200|>0.999
71912969|NCT00633893|143346030|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2891|||<|0.0001|TWO_SIDED|95.0|0.1902|0.4395||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4395|0.1902|<0.0001
71868495|NCT05172050|143254068|SUPERIORITY||Odds Ratio (OR)|1.066|||>|0.999|TWO_SIDED|95.0|0.208|5.478|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||5.478|0.208|>0.999
71868496|NCT05172050|143254068|SUPERIORITY||Odds Ratio (OR)|2.068||||0.5465|TWO_SIDED|95.0|0.369|12.58|||Regression, Logistic|Analysis is based on Exact Binary logistic regression model with treatment group, age group and status as main effects||at Day 28||12.580|0.369|0.5465
71868497|NCT05172050|143254071|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R60 vs Placebo||||0.3899
71868498|NCT05172050|143254071|SUPERIORITY|||||||0.4075||||||P-Value comparing % among treatment groups Raloxifene 120 mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 7 R120 vs placebo||||0.4075
71868499|NCT05172050|143254071|SUPERIORITY|||||||0.3899||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R60 vs placebo||||0.3899
71868500|NCT05172050|143254071|SUPERIORITY|||||||0.4075|||||||Fisher Exact|P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 14 R120 vs placebo||||0.4075
71868501|NCT05172050|143254071|SUPERIORITY|||||||0.6846||||||P-Value comparing % among treatment groups Raloxifene 60mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R60 vs placebo||||0.6846
71868502|NCT05172050|143254071|SUPERIORITY|||||||0.6614||||||P-Value comparing % among treatment groups Raloxifene 120mg versus Placebo using Fisher's Exact test.|Fisher Exact|||The proportion of hospitalized participants who at the beginning of the study were at domicile isolation at Day 7, Day 14 and Day 28 after randomization was analysed using comparison of proportions (i.e. comparisons of each active treatment group versus placebo at each assessment day) through Fisher's exact test and was summarized using frequency and percent by treatment and visit. Herein Day 28 R120 vs placebo||||0.6614
71868503|NCT05172050|143254073|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0|||Log Rank|||||1.00|1.00|
71868504|NCT05172050|143254073|SUPERIORITY||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|1.0|1.0||p value= not estimable|Log Rank|||||1.00|1.00|
71868505|NCT00604825|143254086|SUPERIORITY||Adjusted Mean Difference|0.75||||0.215|TWO_SIDED|95.0|-0.44|1.93||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||1.93|-0.44|0.215
71868506|NCT00604825|143254086|SUPERIORITY||Adjusted Mean Difference|1.21||||0.041|TWO_SIDED|95.0|0.05|2.37||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||2.37|0.05|0.041
71868507|NCT00604825|143254086|SUPERIORITY||Adjusted Mean Difference|-2.06|||<|0.001|TWO_SIDED|95.0|-3.2|-0.92||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.92|-3.20|<0.001
71868508|NCT00604825|143254087|SUPERIORITY||Adjusted Mean Difference|0.15||||0.202|TWO_SIDED|95.0|-0.08|0.38||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg||0.38|-0.08|0.202
71868509|NCT00604825|143254087|SUPERIORITY||Adjusted Mean Difference|0.31||||0.008|TWO_SIDED|95.0|0.08|0.54||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg||0.54|0.08|0.008
71868510|NCT00604825|143254087|SUPERIORITY||Adjusted Mean Difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.75|-0.3||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg||-0.30|-0.75|<0.001
71868511|NCT04617275|143254130|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.5863|TWO_SIDED|90.0|-15.23|19.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||19.85|-15.23|0.5863
71868512|NCT04617275|143254130|SUPERIORITY||Mean Difference (Final Values)|-17.41||||0.0494|TWO_SIDED|90.0|-34.75|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-34.75|0.0494
71868513|NCT04617275|143254130|SUPERIORITY||Mean Difference (Final Values)|-30.85||||0.0019|TWO_SIDED|90.0|-48.09|-13.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-13.61|-48.09|0.0019
71868514|NCT04617275|143254130|SUPERIORITY||Mean Difference (Final Values)|-33.66||||0.0009|TWO_SIDED|90.0|-51.0|-16.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-16.32|-51.00|0.0009
71868515|NCT04617275|143254130|SUPERIORITY||Mean Difference (Final Values)|-19.52||||0.0343|TWO_SIDED|90.0|-37.12|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-37.12|0.0343
71868516|NCT04617275|143254131|SUPERIORITY||Mean Difference (Final Values)|-3.33||||0.3804|TWO_SIDED|90.0|-21.41|14.76||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||14.76|-21.41|0.3804
71868517|NCT04617275|143254131|SUPERIORITY||Mean Difference (Final Values)|-19.65||||0.0348|TWO_SIDED|90.0|-37.44|-1.87||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.87|-37.44|0.0348
71868518|NCT04617275|143254131|SUPERIORITY||Mean Difference (Final Values)|-32.8||||0.0014|TWO_SIDED|90.0|-50.54|-15.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-15.05|-50.54|0.0014
71868519|NCT04617275|143254131|SUPERIORITY||Mean Difference (Final Values)|-35.85||||0.0007|TWO_SIDED|90.0|-53.9|-17.81||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-17.81|-53.90|0.0007
71868520|NCT04617275|143254131|SUPERIORITY||Mean Difference (Final Values)|-28.49||||0.0052|TWO_SIDED|90.0|-46.6|-10.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-10.37|-46.60|0.0052
71868521|NCT04617275|143254132|SUPERIORITY||Mean Difference (Final Values)|-25.58||||0.025|TWO_SIDED|90.0|-46.97|-4.18||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.18|-46.97|0.0250
71868522|NCT04617275|143254132|SUPERIORITY||Mean Difference (Final Values)|-32.95||||0.0053|TWO_SIDED|90.0|-53.95|-11.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-11.95|-53.95|0.0053
71868523|NCT04617275|143254132|SUPERIORITY||Mean Difference (Final Values)|-40.07||||0.0012|TWO_SIDED|90.0|-61.41|-18.73|||Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-18.73|-61.41|0.0012
71912970|NCT00633893|143346030|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3774|||<|0.0001|TWO_SIDED|95.0|0.2577|0.5525||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5525|0.2577|<0.0001
71912971|NCT00633893|143346031|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2422|||<|0.0001|TWO_SIDED|95.0|0.1476|0.3975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3975|0.1476|<0.0001
71912972|NCT00633893|143346031|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.1861|||<|0.0001|TWO_SIDED|95.0|0.1062|0.3261||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.3261|0.1062|<0.0001
71868524|NCT04617275|143254132|SUPERIORITY||Mean Difference (Final Values)|-45.47||||0.0003|TWO_SIDED|90.0|-66.85|-24.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-24.10|-66.85|0.0003
71868525|NCT04617275|143254132|SUPERIORITY||Mean Difference (Final Values)|-33.63||||0.0055|TWO_SIDED|90.0|-55.19|-12.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-12.08|-55.19|0.0055
71868526|NCT04617275|143254133|SUPERIORITY||Mean Difference (Final Values)|-27.79||||0.0127|TWO_SIDED|90.0|-48.12|-7.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-7.47|-48.12|0.0127
71868527|NCT04617275|143254133|SUPERIORITY||Mean Difference (Final Values)|-25.67||||0.0171|TWO_SIDED|90.0|-45.51|-5.83||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-5.83|-45.51|0.0171
71868528|NCT04617275|143254133|SUPERIORITY||Mean Difference (Final Values)|-46.94||||0.0001|TWO_SIDED|90.0|-67.16|-26.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-26.72|-67.16|0.0001
71868529|NCT04617275|143254133|SUPERIORITY||Mean Difference (Final Values)|-33.79||||0.0037|TWO_SIDED|90.0|-54.32|-13.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-13.27|-54.32|0.0037
71868530|NCT04617275|143254133|SUPERIORITY||Mean Difference (Final Values)|-42.13||||0.0005|TWO_SIDED|90.0|-62.85|-21.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-21.40|-62.85|0.0005
71868531|NCT04617275|143254134|SUPERIORITY||Mean Difference (Final Values)|-12.85||||0.1678|TWO_SIDED|90.0|-34.9|9.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||9.21|-34.90|0.1678
71868532|NCT04617275|143254134|SUPERIORITY||Mean Difference (Final Values)|-14.82||||0.1223|TWO_SIDED|90.0|-35.85|6.21||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||6.21|-35.85|0.1223
71868533|NCT04617275|143254134|SUPERIORITY||Mean Difference (Final Values)|-33.97||||0.0054|TWO_SIDED|90.0|-55.66|-12.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-12.28|-55.66|0.0054
71868534|NCT04617275|143254134|SUPERIORITY||Mean Difference (Final Values)|1.31||||0.5398|TWO_SIDED|90.0|-20.38|22.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||22.99|-20.38|0.5398
71868535|NCT04617275|143254134|SUPERIORITY||Mean Difference (Final Values)|-14.42||||0.1409|TWO_SIDED|90.0|-36.56|7.72||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||7.72|-36.56|0.1409
71868536|NCT04617275|143254135|SUPERIORITY||Mean Difference (Final Values)|-28.65||||0.0236|TWO_SIDED|90.0|-52.31|-4.99||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.99|-52.31|0.0236
71868537|NCT04617275|143254135|SUPERIORITY||Mean Difference (Final Values)|-27.32||||0.0226|TWO_SIDED|90.0|-49.67|-4.97||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-4.97|-49.67|0.0226
71868538|NCT04617275|143254135|SUPERIORITY||Mean Difference (Final Values)|-40.85||||0.0022|TWO_SIDED|90.0|-64.11|-17.59||1-Sided|Mixed Models Analysis|MMRM|Test = PF06882961 Reference = Placebo|||-17.59|-64.11|0.0022
71868539|NCT04617275|143254135|SUPERIORITY||Mean Difference (Final Values)|-10.25||||0.2335|TWO_SIDED|90.0|-33.59|13.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||13.08|-33.59|0.2335
71682942|NCT01172808|142883963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|STANDARD_ERROR_OF_MEAN|0.031||0.0008|TWO_SIDED|95.0|0.042|0.162|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model. Spatial power used as covariance structure. The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||0.162|0.042|0.0008
71682943|NCT01172808|142883964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.032||0.0001|TWO_SIDED|95.0|0.062|0.189|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.189|0.062|0.0001
71682944|NCT01172808|142883964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.033||0.02|TWO_SIDED|95.0|0.012|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.140|0.012|0.0200
71682945|NCT01172808|142883965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.224|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.171|0.278|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.278|0.171|<0.0001
71868540|NCT04617275|143254135|SUPERIORITY||Mean Difference (Final Values)|-24.38||||0.0494|TWO_SIDED|90.0|-48.69|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-48.69|0.0494
71868541|NCT04617275|143254136|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.2485|TWO_SIDED|90.0|-0.31|0.13||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.13|-0.31|0.2485
71868542|NCT04617275|143254136|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.0252|TWO_SIDED|90.0|-0.48|-0.04||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.04|-0.48|0.0252
71868543|NCT04617275|143254136|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0053|TWO_SIDED|90.0|-0.56|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-0.56|0.0053
71868544|NCT04617275|143254136|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.009|TWO_SIDED|90.0|-0.54|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-0.54|0.0090
71868545|NCT04617275|143254136|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.1066|TWO_SIDED|90.0|-0.39|0.05||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.05|-0.39|0.1066
71868546|NCT04617275|143254137|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.274|TWO_SIDED|90.0|-0.4|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-0.40|0.2740
71868547|NCT04617275|143254137|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.0196|TWO_SIDED|90.0|-0.66|-0.08||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.08|-0.66|0.0196
71682946|NCT01172808|142883965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.195|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001|TWO_SIDED|95.0|0.141|0.249|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.249|0.141|<0.0001
71682947|NCT01172808|142883966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001|TWO_SIDED|95.0|0.1|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.215|0.100|<0.0001
71868548|NCT04617275|143254137|SUPERIORITY||Mean Difference (Final Values)|-0.59||||0.0006|TWO_SIDED|90.0|-0.88|-0.3|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.30|-0.88|0.0006
71868549|NCT04617275|143254137|SUPERIORITY||Mean Difference (Final Values)|-0.53||||0.0019|TWO_SIDED|90.0|-0.82|-0.23||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.23|-0.82|0.0019
71868550|NCT04617275|143254137|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0243|TWO_SIDED|90.0|-0.66|-0.06||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.06|-0.66|0.0243
71868551|NCT04617275|143254138|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.1587|TWO_SIDED|90.0|-0.62|0.15||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.15|-0.62|0.1587
71868552|NCT04617275|143254138|SUPERIORITY||Mean Difference (Final Values)|-0.66||||0.0027|TWO_SIDED|90.0|-1.04|-0.27||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.27|-1.04|0.0027
71868553|NCT04617275|143254138|SUPERIORITY||Mean Difference (Final Values)|-0.85||||0.0002|TWO_SIDED|90.0|-1.24|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.24|0.0002
71868554|NCT04617275|143254138|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.0016|TWO_SIDED|90.0|-1.1|-0.32||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.32|-1.10|0.0016
71868555|NCT04617275|143254138|SUPERIORITY||Mean Difference (Final Values)|-0.67||||0.0027|TWO_SIDED|90.0|-1.07|-0.28||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.28|-1.07|0.0027
71868556|NCT04617275|143254139|SUPERIORITY||Mean Difference (Final Values)|-0.43||||0.0472|TWO_SIDED|90.0|-0.86|-0.01||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.01|-0.86|0.0472
71868557|NCT04617275|143254139|SUPERIORITY||Mean Difference (Final Values)|-0.87||||0.0004|TWO_SIDED|90.0|-1.29|-0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.45|-1.29|0.0004
71868558|NCT04617275|143254139|SUPERIORITY||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|90.0|-1.53|-0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.68|-1.53|<0.0001
71868559|NCT04617275|143254139|SUPERIORITY||Mean Difference (Final Values)|-0.93||||0.0003|TWO_SIDED|90.0|-1.36|-0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.50|-1.36|0.0003
71868560|NCT04617275|143254139|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.0004|TWO_SIDED|90.0|-1.34|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-1.34|0.0004
71868561|NCT04617275|143254140|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.0116|TWO_SIDED|90.0|-1.18|-0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.19|-1.18|0.0116
71868562|NCT04617275|143254140|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.0008|TWO_SIDED|90.0|-1.43|-0.46|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.43|0.0008
71868563|NCT04617275|143254140|SUPERIORITY||Mean Difference (Final Values)|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.66|-0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.67|-1.66|<0.0001
71868564|NCT04617275|143254140|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0017|TWO_SIDED|90.0|-1.4|-0.4||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.40|-1.40|0.0017
71868565|NCT04617275|143254140|SUPERIORITY||Mean Difference (Final Values)|-1.05||||0.0004|TWO_SIDED|90.0|-1.55|-0.55||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.55|-1.55|0.0004
71868566|NCT04617275|143254141|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0132|TWO_SIDED|90.0|-1.32|-0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.20|-1.32|0.0132
71868567|NCT04617275|143254141|SUPERIORITY||Mean Difference (Final Values)|-1.0||||0.0014|TWO_SIDED|90.0|-1.55|-0.46||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.46|-1.55|0.0014
71868568|NCT04617275|143254141|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.8|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.80|0.0002
71868569|NCT04617275|143254141|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.0174|TWO_SIDED|90.0|-1.29|-0.16|||Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.16|-1.29|0.0174
71868570|NCT04617275|143254141|SUPERIORITY||Mean Difference (Final Values)|-1.25||||0.0002|TWO_SIDED|90.0|-1.82|-0.69||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.69|-1.82|0.0002
71868571|NCT04617275|143254142|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.2843|TWO_SIDED|90.0|-1.02|0.5||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.50|-1.02|0.2843
71868572|NCT04617275|143254142|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.431|TWO_SIDED|90.0|-0.84|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-0.84|0.4310
71868573|NCT04617275|143254142|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.2402|TWO_SIDED|90.0|-1.07|0.43||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.43|-1.07|0.2402
71868574|NCT04617275|143254142|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1397|TWO_SIDED|90.0|-1.24|0.26||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.26|-1.24|0.1397
71868575|NCT04617275|143254142|SUPERIORITY||Mean Difference (Final Values)|-0.07||||0.4393|TWO_SIDED|90.0|-0.85|0.71||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.71|-0.85|0.4393
71868576|NCT04617275|143254143|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.1491|TWO_SIDED|90.0|-2.0|0.45||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.45|-2.00|0.1491
71868577|NCT04617275|143254143|SUPERIORITY||Median Difference (Final Values)|0.12||||0.5664|TWO_SIDED|90.0|-1.09|1.34||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.34|-1.09|0.5664
71868578|NCT04617275|143254143|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.0632|TWO_SIDED|90.0|-2.33|0.09||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.09|-2.33|0.0632
71868579|NCT04617275|143254143|SUPERIORITY||Median Difference (Final Values)|-1.01||||0.0847|TWO_SIDED|90.0|-2.23|0.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.20|-2.23|0.0847
71868580|NCT04617275|143254143|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5264|TWO_SIDED|90.0|-1.2|1.3||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.30|-1.20|0.5264
71868581|NCT04617275|143254144|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.0395|TWO_SIDED|90.0|-2.86|-0.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.10|-2.86|0.0395
71868582|NCT04617275|143254144|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.3726|TWO_SIDED|90.0|-1.63|1.1||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.10|-1.63|0.3726
71868583|NCT04617275|143254144|SUPERIORITY||Mean Difference (Final Values)|-2.36||||0.0028|TWO_SIDED|90.0|-3.74|-0.98||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.98|-3.74|0.0028
71868584|NCT04617275|143254144|SUPERIORITY||Mean Difference (Final Values)|-1.85||||0.0139|TWO_SIDED|90.0|-3.23|-0.47||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.47|-3.23|0.0139
71868585|NCT04617275|143254144|SUPERIORITY||Mean Difference (Final Values)|-0.78||||0.1815|TWO_SIDED|90.0|-2.19|0.64||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.64|-2.19|0.1815
71868586|NCT04617275|143254145|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.0112|TWO_SIDED|90.0|-3.71|-0.61||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.61|-3.71|0.0112
71868587|NCT04617275|143254145|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.2161|TWO_SIDED|90.0|-2.24|0.8||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.80|-2.24|0.2161
71868588|NCT04617275|143254145|SUPERIORITY||Mean Difference (Final Values)|-3.47||||0.0002|TWO_SIDED|90.0|-5.02|-1.92||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.92|-5.02|0.0002
71868589|NCT04617275|143254145|SUPERIORITY||Mean Difference (Final Values)|-2.05||||0.0147|TWO_SIDED|90.0|-3.59|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-3.59|0.0147
71868590|NCT04617275|143254145|SUPERIORITY||Mean Difference (Final Values)|-2.97||||0.0013|TWO_SIDED|90.0|-4.56|-1.37||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.37|-4.56|0.0013
71868591|NCT04617275|143254146|SUPERIORITY||Mean Difference (Final Values)|-2.46||||0.0111|TWO_SIDED|90.0|-4.22|-0.7||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.70|-4.22|0.0111
71912973|NCT00633893|143346032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2799|||<|0.0001|TWO_SIDED|95.0|0.1844|0.4247||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.4247|0.1844|<0.0001
71912974|NCT00633893|143346032|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3653|||<|0.0001|TWO_SIDED|95.0|0.25|0.5338||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.5338|0.2500|<0.0001
71912975|NCT00633893|143346033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2615|||<|0.0001|TWO_SIDED|95.0|0.1593|0.4292||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.||0.4292|0.1593|<0.0001
71912976|NCT00633893|143346033|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3972|||<|0.0001|TWO_SIDED|95.0|0.2595|0.6079||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||0.6079|0.2595|<0.0001
71682948|NCT01172808|142883966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.029||0.0003|TWO_SIDED|95.0|0.049|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.164|0.049|0.0003
71868592|NCT04617275|143254146|SUPERIORITY||Mean Difference (Final Values)|-1.03||||0.16|TWO_SIDED|90.0|-2.75|0.68||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.68|-2.75|0.1600
71868593|NCT04617275|143254146|SUPERIORITY||Mean Difference (Final Values)|-4.27|||<|0.0001|TWO_SIDED|90.0|-6.03|-2.52||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.52|-6.03|<0.0001
71868594|NCT04617275|143254146|SUPERIORITY||Mean Difference (Final Values)|-2.68||||0.0061|TWO_SIDED|90.0|-4.42|-0.94||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.94|-4.42|0.0061
71868595|NCT04617275|143254146|SUPERIORITY||Mean Difference (Final Values)|-3.71||||0.0005|TWO_SIDED|90.0|-5.52|-1.89||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.89|-5.52|0.0005
71868596|NCT04617275|143254147|SUPERIORITY||Mean Difference (Final Values)|-3.21||||0.0047|TWO_SIDED|90.0|-5.22|-1.2||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-1.20|-5.22|0.0047
71868597|NCT04617275|143254147|SUPERIORITY||Mean Difference (Final Values)|-1.51||||0.1003|TWO_SIDED|90.0|-3.45|0.44||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.44|-3.45|0.1003
71868598|NCT04617275|143254147|SUPERIORITY||Mean Difference (Final Values)|-4.95|||<|0.0001|TWO_SIDED|90.0|-6.96|-2.95||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.95|-6.96|<0.0001
71868599|NCT04617275|143254147|SUPERIORITY||Mean Difference (Final Values)|-2.5||||0.0197|TWO_SIDED|90.0|-4.49|-0.51||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.51|-4.49|0.0197
71868600|NCT04617275|143254147|SUPERIORITY||Mean Difference (Final Values)|-4.94|||<|0.0001|TWO_SIDED|90.0|-7.03|-2.85||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-2.85|-7.03|<0.0001
71868601|NCT04617275|143254148|SUPERIORITY||Mean Difference (Final Values)|-0.96||||0.0836|TWO_SIDED|90.0|-2.12|0.19||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.19|-2.12|0.0836
71868602|NCT04617275|143254149|SUPERIORITY||Mean Difference (Final Values)|-1.59||||0.0386|TWO_SIDED|90.0|-3.07|-0.12||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||-0.12|-3.07|0.0386
71868603|NCT04617275|143254150|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.1566|TWO_SIDED|90.0|-3.99|1.0||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||1.00|-3.99|0.1566
71868604|NCT04617275|143254151|SUPERIORITY||Mean Difference (Final Values)|-2.62||||0.0916|TWO_SIDED|90.0|-5.91|0.67||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.67|-5.91|0.0916
71868605|NCT04617275|143254152|SUPERIORITY||Mean Difference (Final Values)|-3.07||||0.059|TWO_SIDED|90.0|-6.31|0.17||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.17|-6.31|0.0590
71912977|NCT00633893|143346034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6087||||0.1084|TWO_SIDED|95.0|0.3653|1.0145||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0145|0.3653|0.1084
71912978|NCT00633893|143346034|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6846||||0.1329|TWO_SIDED|95.0|0.4164|1.1257||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1257|0.4164|0.1329
71868606|NCT04617275|143254153|SUPERIORITY||Mean Difference (Final Values)|-3.74||||0.0826|TWO_SIDED|90.0|-8.23|0.75||1-Sided|Mixed Models Analysis|MMRM|Test = PF-06882961 Reference = Placebo|||0.75|-8.23|0.0826
71868607|NCT05593445|143254187|SUPERIORITY||Odds Ratio (OR)|0.83||||0.737|TWO_SIDED|95.0|0.29|2.41|||Chi-squared|||||2.41|0.29|0.737
71868608|NCT05593445|143254187|SUPERIORITY||response rate difference|-4.3|STANDARD_ERROR_OF_MEAN|12.73|||TWO_SIDED|95.0|-29.2|20.7|||||The 95% confidence interval for the response rate difference was constructed from approximately normal distribution.|||20.7|-29.2|
71868609|NCT05593445|143254188|SUPERIORITY||least squares mean difference|-2.76|STANDARD_ERROR_OF_MEAN|1.14||0.0188|TWO_SIDED|95.0|-5.05|-0.47|||Mixed Model Repeated Measures (MMRM)|||||-0.47|-5.05|0.0188
71868610|NCT05593445|143254189|SUPERIORITY||least squares mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.72||0.4674|TWO_SIDED|95.0|-1.96|0.91|||MMRM|||||0.91|-1.96|0.4674
71868611|NCT05593445|143254190|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9072|TWO_SIDED|95.0|0.503|1.869|||Log Rank||Cox regression model was conducted to compare the difference in hazard rate.|||1.869|0.503|0.9072
71868612|NCT05559476|143254199|NON_INFERIORITY|The non-inferiority is demonstrated if the Upper Limit (UL) of the 2-sided 95% Confidence Interval (CI) of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is less than or equal (\<=)1.5.|GMT Ratio|1.18|||||TWO_SIDED|95.0|1.03|1.35|||||The comparison is done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.35|1.03|
71868613|NCT05559476|143254200|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|95.0|0.85|1.16|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.16|0.85|
71868614|NCT05559476|143254200|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.8|1.09|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.09|0.80|
71868615|NCT05559476|143254200|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.95|||||TWO_SIDED|95.0|0.88|1.03|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.03|0.88|
71868616|NCT05559476|143254200|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.02|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.02|0.84|
71868617|NCT05559476|143254201|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSVPreF3 OA vaccine is \<=1.5.|GMT Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||The comparison was done using the adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.15|0.89|
71868618|NCT05559476|143254202|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-1.71|||||TWO_SIDED|95.0|-8.15|4.74||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||4.74|-8.15|
71868619|NCT05559476|143254202|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-4.11|||||TWO_SIDED|95.0|-10.67|2.48||||||To evaluate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||2.48|-10.67|
71868620|NCT05559476|143254202|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-8.56|||||TWO_SIDED|95.0|-14.75|-2.29||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||-2.29|-14.75|
71868621|NCT05559476|143254202|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|-5.89|||||TWO_SIDED|95.0|-12.28|0.56||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||0.56|-12.28|
71868622|NCT00969709|143254219|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.23||||0.0186|TWO_SIDED|95.0|-5.92|-0.54|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.54|-5.92|0.0186
71868623|NCT00969709|143254219|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.99||||0.0038|TWO_SIDED|95.0|-6.69|-1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-1.29|-6.69|0.0038
71868624|NCT00969709|143254219|SUPERIORITY_OR_OTHER||Least squares mean difference|-4.86||||0.0005|TWO_SIDED|95.0|-7.59|-2.12|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-2.12|-7.59|0.0005
71868625|NCT00969709|143254220|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.41||||0.1687|TWO_SIDED|95.0|-3.42|0.6|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||0.60|-3.42|0.1687
71868626|NCT00969709|143254220|SUPERIORITY_OR_OTHER||least squares mean difference|-2.51||||0.0151|TWO_SIDED|95.0|-4.54|-0.49|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.49|-4.54|0.0151
71868627|NCT00969709|143254220|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.57||||0.0141|TWO_SIDED|95.0|-4.62|-0.52|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.52|-4.62|0.0141
71868628|NCT02233543|143254235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.2419|TWO_SIDED|95.0|-1.21|0.32|||Mixed Models Analysis|||||0.32|-1.21|0.2419
71868629|NCT02233543|143254236|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.79||||0.2016|TWO_SIDED|95.0|-4.51|20.08|||Mixed Models Analysis|||||20.08|-4.51|0.2016
71868630|NCT00266227|143254247|SUPERIORITY_OR_OTHER|||||||0.0195|||||||Cochran-Mantel-Haenszel|||||||0.0195
71868631|NCT00266227|143254249|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||||95.0|-0.7|-0.1|||ANOVA|Adjusted mean for Arm A (Rituxan) is -1.9 and adjusted mean for Arm B (Placebo) is -1.5.||Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.||-0.1|-0.7|
71868632|NCT03573583|143254267|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.03|TWO_SIDED|95.0|0.22|4.36||No formal adjustment for type I error due to the pilot nature of the study. All significance tests were 2-tailed and an alpha level of 0.05 was required for significance.|ANCOVA|Adjusted for baseline score.||Continuous variables were expressed as mean (SD) and categorical variables were as frequencies and percentages. A 2-sided independent-sample t test was used to compare group differences in change scores. Change scores were calculated as Week 16 measurements minus baseline measurements. Statistical analyses were done by a blinded statistician without knowledge of group membership.||4.36|0.22|0.03
71868633|NCT03573583|143254268|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.009|TWO_SIDED|95.0|0.31|1.77|||ANCOVA|Adjusted for baseline score.||||1.77|0.31|0.009
71868634|NCT03573583|143254269|SUPERIORITY||Mean Difference (Final Values)|1.29||||0.07|TWO_SIDED|95.0|-0.1|2.67|||ANCOVA|Baseline as covariate||||2.67|-0.10|0.07
71868635|NCT03573583|143254270|OTHER|Pearson's correlation coefficients, along with their 95% confidence intervals (CIs)|Pearson's Correlation coefficient|0.19||||0.49|TWO_SIDED|95.0|-0.35|0.64|||Pearson's Correlation coefficient|||||0.64|-0.35|0.49
71868636|NCT00210470|143254281|EQUIVALENCE|The correlation of each of the above variables at biopsy/Day 1, surgery/Day 21, and change with percent change in the longest diameter (LD) of the primary tumor was calculated using Spearman rank correlations (183 correlations). Due to outliers in the distribution of percent change in the longest diameter, it was felt that the Spearman rank correlations would be more appropriate than Pearson correlations.|||||<|0.1|||||||Spearman Rank|||||||<0.10
71868637|NCT00037830|143254326|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.||||<0.0001
71912979|NCT00633893|143346035|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.647||||0.3059|TWO_SIDED|95.0|0.3543|1.1813||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1813|0.3543|0.3059
71912980|NCT00633893|143346035|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9416||||0.8288|TWO_SIDED|95.0|0.5458|1.6245||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.6245|0.5458|0.8288
71868638|NCT00037830|143254327|SUPERIORITY_OR_OTHER|||||||0.0368|||||||t-test, 2 sided|||The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.||||0.0368
71868639|NCT00037830|143254328|SUPERIORITY_OR_OTHER|||||||0.1903|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.1903
71868640|NCT00037830|143254328|SUPERIORITY_OR_OTHER|||||||0.0063||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0063
71868641|NCT00037830|143254329|SUPERIORITY_OR_OTHER|||||||0.0502|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure||||||0.0502
71868642|NCT00037830|143254329|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||estimate slope of change over time|random intercept model and a variance components covariance structure||||||0.0003
71868643|NCT00037830|143254330|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71868644|NCT00037830|143254331|SUPERIORITY_OR_OTHER|||||||0.131|||||||t-test, 2 sided|||||||0.1310
71868645|NCT00037830|143254332|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 2 sided|||Analysis was paired sample t-test on change from baseline.||||<0.05
71868646|NCT00037830|143254333|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71868647|NCT00037830|143254334|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71868648|NCT00037830|143254335|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 2 sided|||||||<0.01
71868649|NCT01014143|143254349|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71868650|NCT02029872|143254350|OTHER|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.||||||||||||||||Due to low enrollment in the intervention, statistical analysis was not possible.|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.|||
71868651|NCT02065687|143254380|EQUIVALENCE|The null hypothesis is that there is no relationship between BMI and metformin treatment (i.e. the parameter associated with the interaction term of BMI \* treatment is equal to 0).|Cox Proportional Hazard|-0.01787|STANDARD_ERROR_OF_MEAN|0.27472||0.9482|TWO_SIDED||||||Regression, Cox|||The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. Historical data indicate that approximately 50% of people are obese (BMI\>=30). For the purposes of examining the relationship, we will classify patients into two levels (high versus low) at the median BMI, which will increase the likelihood of detecting an interaction between metformin treatment and obesity.||||0.9482
71868652|NCT01871805|143254387|SUPERIORITY|||||||0.0056||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0056
71868653|NCT01871805|143254388|SUPERIORITY|||||||0.0251||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0251
71868654|NCT01871805|143254388|SUPERIORITY|||||||0.0203||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0203
71868655|NCT01871805|143254390|SUPERIORITY|||||||0.001||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided|||||||0.0010
71868656|NCT03412747|143254416|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|39.3|||||TWO_SIDED|95.0|30.9|47.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||47.7|30.9|
71868657|NCT03412747|143254416|SUPERIORITY||Odds Ratio (OR)|7.459|||<|0.001|TWO_SIDED|95.0|4.709|11.816||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.816|4.709|<0.001
71682949|NCT01172808|142883967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.907|STANDARD_ERROR_OF_MEAN|4.994|<|0.0001|TWO_SIDED|95.0|28.113|47.7|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||47.700|28.113|<0.0001
71912981|NCT00633893|143346036|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5794||||0.1316|TWO_SIDED|95.0|0.3215|1.0443||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.0443|0.3215|0.1316
71868658|NCT03412747|143254417|NON_INFERIORITY|The evaluation of non-inferiority is tested at a 1-sided alpha level of 0.025 and based on a 1-sided 97.5% CI and a non-inferiority margin of 10%.|Risk Difference (RD)|28.2|||||TWO_SIDED|95.0|19.7|36.7||||||Risk Difference: BKZ-ADA calculated using stratified CMH.||36.7|19.7|
71868659|NCT03412747|143254417|SUPERIORITY||Odds Ratio (OR)|4.341|||<|0.001|TWO_SIDED|95.0|2.785|6.765||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||6.765|2.785|<0.001
71868660|NCT03412747|143254418|SUPERIORITY||Odds Ratio (OR)|6.231|||<|0.001|TWO_SIDED|95.0|3.515|11.046||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||11.046|3.515|<0.001
71868661|NCT03412747|143254418|SUPERIORITY||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.657|9.041||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||9.041|3.657|<0.001
71868662|NCT03412747|143254419|SUPERIORITY||Odds Ratio (OR)|4.724|||<|0.001|TWO_SIDED|95.0|2.683|8.318||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.318|2.683|<0.001
71868663|NCT03412747|143254419|SUPERIORITY||Odds Ratio (OR)|4.762|||<|0.001|TWO_SIDED|95.0|3.014|7.523||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.523|3.014|<0.001
71868664|NCT03412747|143254420|SUPERIORITY||Odds Ratio (OR)|7.103|||<|0.001|TWO_SIDED|95.0|4.637|10.88||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||10.880|4.637|<0.001
71868665|NCT03412747|143254421|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.23|7.661||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||7.661|3.230|<0.001
71868666|NCT03412747|143254422|SUPERIORITY||Odds Ratio (OR)|5.249|||<|0.001|TWO_SIDED|95.0|3.207|8.593||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||8.593|3.207|<0.001
71868667|NCT03412747|143254422|SUPERIORITY||Odds Ratio (OR)|4.974|||<|0.001|TWO_SIDED|95.0|3.257|7.594||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: BKZ/ADA calculated using stratified CMH test with region and prior biologic exposure as stratification variables.||7.594|3.257|<0.001
71868668|NCT00468104|143254431|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.||||<0.001
71868669|NCT01131182|143254476|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0||||Assessed for relative risk using prior therapy (monotherapy or combination therapy) as a stratification factor.|Cochran-Mantel-Haenszel|||||||0.0005
71868670|NCT00662818|143254478|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.329|TWO_SIDED|95.0|0.62|4.25|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.25|0.62|0.329
71868671|NCT00662818|143254479|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.42|TWO_SIDED|95.0|0.59|3.5|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.50|0.59|0.420
71868672|NCT00662818|143254483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.648|TWO_SIDED|95.0|0.52|2.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.85|0.52|0.648
71868673|NCT00662818|143254484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.647|TWO_SIDED|95.0|0.31|2.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||2.07|0.31|0.647
71868674|NCT00662818|143254485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.201|TWO_SIDED|95.0|0.73|4.6|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||4.60|0.73|0.201
71868675|NCT00662818|143254486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.579|TWO_SIDED|95.0|0.47|3.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.||||3.85|0.47|0.579
71868676|NCT04602221|143254487|OTHER||Difference of adjusted means|-0.339|STANDARD_ERROR_OF_MEAN|3.8242||0.9296|TWO_SIDED|95.0|-7.975|7.297|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||7.297|-7.975|0.9296
71868677|NCT04602221|143254487|OTHER||Difference of adjusted means|4.002|STANDARD_ERROR_OF_MEAN|3.8224||0.299|TWO_SIDED|95.0|-3.631|11.634|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||11.634|-3.631|0.2990
71868678|NCT04602221|143254487|OTHER||Difference of adjusted means|-1.258|STANDARD_ERROR_OF_MEAN|3.6608||0.7322|TWO_SIDED|95.0|-8.565|6.05|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the primary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||6.050|-8.565|0.7322
71868679|NCT04602221|143254488|OTHER||Difference of adjusted means|0.347|STANDARD_ERROR_OF_MEAN|1.563||0.8249|TWO_SIDED|95.0|-2.776|3.471|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||3.471|-2.776|0.8249
71868680|NCT04602221|143254488|OTHER||Difference of adjusted means|-1.085|STANDARD_ERROR_OF_MEAN|1.5889||0.4973|TWO_SIDED|95.0|-4.26|2.091|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||2.091|-4.260|0.4973
71912982|NCT00633893|143346036|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8433||||0.5288|TWO_SIDED|95.0|0.4959|1.4341||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.4341|0.4959|0.5288
71912983|NCT00633893|143346037|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6577||||0.2361|TWO_SIDED|95.0|0.3874|1.1169||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.1169|0.3874|0.2361
71868681|NCT04602221|143254488|OTHER||Difference of adjusted means|-2.858|STANDARD_ERROR_OF_MEAN|1.5266||0.0658|TWO_SIDED|95.0|-5.909|0.192|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.192|-5.909|0.0658
71868682|NCT04602221|143254489|OTHER||Difference of adjusted means|0.0053|STANDARD_ERROR_OF_MEAN|0.00798||0.5081|TWO_SIDED|95.0|-0.0106|0.0213|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0213|-0.0106|0.5081
71868683|NCT04602221|143254489|OTHER||Difference of adjusted means|0.0058|STANDARD_ERROR_OF_MEAN|0.00798||0.4723|TWO_SIDED|95.0|-0.0102|0.0217|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0217|-0.0102|0.4723
71868684|NCT04602221|143254489|OTHER||Difference of adjusted means|0.0333|STANDARD_ERROR_OF_MEAN|0.00767|<|0.0001|TWO_SIDED|95.0|0.018|0.0486|||ANCOVA||The difference was calculated as treatment group minus placebo group.|A linear mixed effects model, i.e. analyses of covariance (ANCOVA) was used for analysis of the secondary endpoint. This model included effects for sequence, subject within sequence, period, baseline values (pre-ketamine baseline and on-ketamine baseline) and treatment. The effect 'subject within sequence' were considered as random, whereas the other effects were considered as fixed.||0.0486|0.0180|< .0001
71868685|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.002||||||This is the PCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.002
71868686|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.23||||||This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.23
71682950|NCT01172808|142883967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.677|STANDARD_ERROR_OF_MEAN|5.023|<|0.0001|TWO_SIDED|95.0|23.825|43.529|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||43.529|23.825|<0.0001
71868687|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.18||||||This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.18
71868688|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
71868689|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.004||||||This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.004
71868690|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
71868691|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.21||||||This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.21
71868692|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
71868693|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
71868694|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.14||||||This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.14
71868695|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.45||||||This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.45
71868696|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.79||||||This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.79
71868697|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.77
71868698|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.03||||||This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.03
71868699|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.12||||||This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.12
71868700|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.29||||||This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.29
71868701|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.01||||||This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.01
71868702|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.08||||||This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.08
71868703|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.61||||||This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.61
71868704|NCT02270515|143254496|SUPERIORITY_OR_OTHER|||||||0.02||||||This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."||||0.02
71868705|NCT00911768|143254502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.416|<|0.05||95.0|-0.647|1.008|||t-test, 2 sided|||||1.008|-0.647|<0.05
71868706|NCT00911768|143254503|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.346|STANDARD_ERROR_OF_MEAN|0.116|<|0.05||95.0|-0.576|-0.115|||t-test, 2 sided|||||-0.115|-0.576|<0.05
71682951|NCT01172808|142883968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.066||0.2717|TWO_SIDED|95.0|-0.057|0.203|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.203|-0.057|0.2717
71868707|NCT00911768|143254504|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.086|STANDARD_ERROR_OF_MEAN|0.035|<|0.05||95.0|-0.155|-0.017|||t-test, 2 sided|||||-0.017|-0.155|<0.05
71868708|NCT00467350|143254505|SUPERIORITY_OR_OTHER_LEGACY|"Similar to previous studies, the main outcome measure was the change in the child's main symptom. Changes were determined by the question Has your child's main symptom improved, stayed the same or gotten worse? The main symptom was defined as the chief complaint identified during the triage process. For analysis, responses were dichotomized into 2 groups: improved/better versus worse/same."|||||||||||||||||A χ2 test was used to examine the difference in probabilities of experiencing an outcome between treatment arms and differences were expressed by Mantel-Haenszel common OR estimate with 95% confidence interval (CI).|||
71868709|NCT03538301|143254507|SUPERIORITY||Slope|-0.004153||||0.049|TWO_SIDED|95.0|-0.008284|-0.000021|||random coefficient model|||Slope in FVC (L/week) in the 45 mg cohort versus placebo||-0.000021|-0.008284|0.049
71868710|NCT03538301|143254507|SUPERIORITY||Slope|-0.002112||||0.316|TWO_SIDED|95.0|-0.00626|0.002036|||random coefficient model|||Slope in FVC (L/week) in the 90 mg cohort versus placebo||0.002036|-0.006260|0.316
71868711|NCT03538301|143254508|SUPERIORITY||Slope|-0.091238||||0.098|TWO_SIDED|95.0|-0.199456|0.016979|||random coefficient model|||||0.016979|-0.199456|0.098
71868712|NCT03538301|143254508|SUPERIORITY||Slope|-0.039596||||0.473|TWO_SIDED|95.0|-0.148248|0.069056|||random coefficient model|||||0.069056|-0.148248|0.473
71868713|NCT03538301|143254509|SUPERIORITY||Mean Difference (Final Values)|-0.0997||||0.049|TWO_SIDED|95.0|-0.1988|-0.0005|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 45 mg cohort versus placebo||-0.0005|-0.1988|0.049
71868714|NCT03538301|143254509|SUPERIORITY||Mean Difference (Final Values)|-0.0507||||0.316|TWO_SIDED|95.0|-0.1502|0.0489|||random coefficient model|||Change from Baseline to Week 24 in FVC (L) in the 90 mg cohort versus placebo||0.0489|-0.1502|0.316
71868715|NCT03538301|143254510|SUPERIORITY||Median Difference (Final Values)|-3.16||||0.668|TWO_SIDED|95.0|-17.59|11.28|||random coefficient model|||||11.28|-17.59|0.668
71868716|NCT03538301|143254510|SUPERIORITY||Median Difference (Final Values)|-1.72||||0.821|TWO_SIDED|95.0|-16.57|13.13|||random coefficient model|||||13.13|-16.57|0.821
71868717|NCT03538301|143254511|SUPERIORITY||Median Difference (Final Values)|-2.1897||||0.098|TWO_SIDED|95.0|-4.7869|0.4075|||random coefficient model|||Change from baseline to Week 24 in ppFVC||0.4075|-4.7869|0.098
71868718|NCT03538301|143254511|SUPERIORITY||Median Difference (Final Values)|-0.9503||||0.473|TWO_SIDED|95.0|-3.5579|1.6573|||random coefficient model|||Change from Baseline to Week 24 in ppFVC||1.6573|-3.5579|0.473
71868719|NCT03538301|143254512|SUPERIORITY||Median Difference (Final Values)|-2.53||||0.7|TWO_SIDED|95.0|-15.4|10.34|||random coefficient model|||||10.34|-15.40|0.700
71868720|NCT03538301|143254512|SUPERIORITY||Median Difference (Final Values)|-1.12||||0.867|TWO_SIDED|95.0|-14.31|12.07|||random coefficient model|||||12.07|-14.31|0.867
71868721|NCT03538301|143254515|SUPERIORITY||Mean Difference (Final Values)|0.146||||0.708|TWO_SIDED|95.0|-0.6226|0.9147|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.9147|-0.6226|0.708
71868722|NCT03538301|143254515|SUPERIORITY||Mean Difference (Final Values)|0.7038||||0.074|TWO_SIDED|95.0|-0.0695|1.4771|||random coefficient|||Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.4771|-0.0695|0.074
71868723|NCT03538301|143254515|SUPERIORITY||Mean Difference (Final Values)|0.114||||0.765|TWO_SIDED|95.0|-0.6362|0.8641|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 45 mg cohort versus placebo||0.8641|-0.6362|0.765
71868724|NCT03538301|143254515|SUPERIORITY||Mean Difference (Final Values)|0.556||||0.148|TWO_SIDED|95.0|-0.1986|1.3107|||random coefficient model|||Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg) in the 90 mg cohort versus placebo||1.3107|-0.1986|0.148
71868725|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-0.48||||0.765|TWO_SIDED|95.0|-3.68|2.71|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 45 mg cohort versus placebo||2.71|-3.68|0.765
71868726|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.37|TWO_SIDED|95.0|-1.68|4.47|||random coefficient model|||Change from Baseline to Week 24 in QLF Score (% of whole lung field volume) in the 90 mg cohort versus placebo||4.47|-1.68|0.370
71868727|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.499|TWO_SIDED|95.0|-0.7|0.34|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 45 mg cohort versus placebo||0.34|-0.70|0.499
71868728|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.901|TWO_SIDED|95.0|-0.47|0.54|||random coefficient model|||Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume) in the 90 mg cohort versus placebo||0.54|-0.47|0.901
71868729|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.676|TWO_SIDED|95.0|-2.25|3.46|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 45 mg cohort versus placebo||3.46|-2.25|0.676
71868730|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|1.64||||0.242|TWO_SIDED|95.0|-1.13|4.42|||random coefficient model|||Change from Baseline to Week 24 in Reticulation (% of whole lung field volume) in the 90 mg cohort versus placebo||4.42|-1.13|0.242
71868731|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-1.21||||0.14|TWO_SIDED|95.0|-2.82|0.4|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 45 mg cohort versus placebo||0.40|-2.82|0.140
71912984|NCT00633893|143346037|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7708||||0.3155|TWO_SIDED|95.0|0.4631|1.2832||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.||1.2832|0.4631|0.3155
71868732|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-0.98||||0.211|TWO_SIDED|95.0|-2.53|0.56|||random coefficient model|||Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume) in the 90 mg cohort versus placebo||0.56|-2.53|0.211
71868733|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.568|TWO_SIDED|95.0|-2.16|3.91|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 45 mg cohort versus placebo||3.91|-2.16|0.568
71868734|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.573|TWO_SIDED|95.0|-3.76|2.09|||random coefficient model|||Change from Baseline to Week 24 in Normal Lung (% of whole lung field volume) in the 90 mg cohort versus placebo||2.09|-3.76|0.573
71868735|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.012|TWO_SIDED|95.0|-6.35|-0.81|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 45 mg cohort versus placebo||-0.81|-6.35|0.012
71868736|NCT03538301|143254516|SUPERIORITY||Mean Difference (Final Values)|-2.16||||0.112|TWO_SIDED|95.0|-4.82|0.51|||random coefficient model|||Change from Baseline to Week 24 in Emphysema (% of whole lung field volume) in the 90 mg cohort versus placebo||0.51|-4.82|0.112
71868737|NCT03538301|143254517|SUPERIORITY|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||||||0.256
71868738|NCT03538301|143254517|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||||||0.241
71868739|NCT03538301|143254518|SUPERIORITY||Hazard Ratio (HR)|0.649||||0.517|TWO_SIDED|95.0|0.189|2.225|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 45 mg cohort versus placebo||2.225|0.189|0.517
71868740|NCT03538301|143254518|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.506|TWO_SIDED|95.0|0.198|2.324|||Log Rank|||Time to First IPF Exacerbation or Death (weeks) in the 90 mg cohort versus placebo||2.324|0.198|0.506
71868741|NCT03538301|143254518|SUPERIORITY||Proportion Difference (Final Values)|-9.3||||0.313|TWO_SIDED|95.0|-25.2|5.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of First IPF Exacerbation (%) in the 45 mg cohort versus placebo||5.5|-25.2|0.313
71868742|NCT03538301|143254518|SUPERIORITY|The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Proportion Difference (Final Values)|-6.7||||0.376|TWO_SIDED|95.0|-22.6|9.2|||Chi-squared|||Rate of First IPF Exacerbation (%) in the 90 mg cohort versus placebo||9.2|-22.6|0.376
71868743|NCT03538301|143254519|SUPERIORITY||Proportion Difference (Final Values)|-4.6||||0.713|TWO_SIDED|95.0|-19.2|9.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 45 mg cohort versus placebo||9.6|-19.2|0.713
71868744|NCT03538301|143254519|SUPERIORITY||Proportion Difference (Final Values)|-4.4||||0.713|TWO_SIDED|95.0|-19.2|10.7|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Hospitalization for Respiratory Ailments (%) in the 90 mg cohort versus placebo||10.7|-19.2|0.713
71868745|NCT03538301|143254520|SUPERIORITY|||||||0.937|||||||Log Rank|||Overall Survival (weeks) in the 45 mg cohort versus placebo||||0.937
71868746|NCT03538301|143254520|SUPERIORITY|||||||0.414|||||||Log Rank|||Overall Survival (weeks) in the 90 mg cohort versus placebo||||0.414
71868747|NCT03538301|143254520|SUPERIORITY||Proportion Difference (Final Values)|0.1|||>|0.999|TWO_SIDED|95.0|-10.4|10.9|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 45 mg cohort versus placebo||10.9|-10.4|>0.999
71868748|NCT03538301|143254520|SUPERIORITY||Proportion Difference (Final Values)|-2.4|||>|0.999|TWO_SIDED|95.0|-13.1|6.8|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Mortality (%) in the 90 mg cohort versus placebo||6.8|-13.1|>0.999
71868749|NCT03538301|143254521|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.6|4.6|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 45 mg cohort versus placebo||4.6|-16.6|0.494
71868750|NCT03538301|143254521|SUPERIORITY||Proportion Difference (Final Values)|-4.8||||0.494|TWO_SIDED|95.0|-16.2|4.5|||Fisher Exact||The 95% Confidence Interval for difference in proportions are based on the Chan-Zhang method.|Rate of Deterioration of IPF Resulting in Lung Transplantation (%) in the 90 mg cohort versus placebo||4.5|-16.2|0.494
71868751|NCT02842151|143254538|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.346|||TWO_SIDED|90.0|-0.03|0.13||||||To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.13|-0.03|
71868752|NCT02842151|143254538|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.07|STANDARD_DEVIATION|0.595|||TWO_SIDED|90.0|-0.21|0.07||||||To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.||0.07|-0.21|
71868753|NCT02842151|143254538|EQUIVALENCE|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.13|STANDARD_DEVIATION|0.34|||TWO_SIDED|90.0|-0.22|-0.04||||||To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.||-0.04|-0.22|
71868754|NCT02559895|143254550|SUPERIORITY||Mean Difference (Final Values)|-1.11|STANDARD_DEVIATION|3.4||0.0001|TWO_SIDED|95.0|-1.68|-0.54|||ANCOVA|||||-0.54|-1.68|0.0001
71868755|NCT02559895|143254550|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_DEVIATION|3.4||0.0182|TWO_SIDED|95.0|-1.25|-0.12|||ANCOVA|||||-0.12|-1.25|0.0182
71868756|NCT02559895|143254550|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_DEVIATION|3.4||0.0046|TWO_SIDED|95.0|-1.39|-0.25|||ANCOVA|||||-0.25|-1.39|0.0046
71868757|NCT02559895|143254551|SUPERIORITY||Mean Difference (Final Values)|13.5||||0.0007|TWO_SIDED|95.0|5.8|21.2|||Cochran-Mantel-Haenszel|||||21.2|5.8|0.0007
71868758|NCT02559895|143254551|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.1126|TWO_SIDED|95.0|-1.4|13.3|||Cochran-Mantel-Haenszel|||||13.3|-1.4|0.1126
71868759|NCT02559895|143254551|SUPERIORITY||Mean Difference (Final Values)|8.4||||0.0272|TWO_SIDED|95.0|1.0|15.9|||Cochran-Mantel-Haenszel|||||15.9|1.0|0.0272
71868760|NCT02559895|143254552|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0066|TWO_SIDED|95.0|3.2|19.3|||Cochran-Mantel-Haenszel|||||19.3|3.2|0.0066
71868761|NCT02559895|143254552|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.0112|TWO_SIDED|95.0|2.4|18.6|||Cochran-Mantel-Haenszel|||||18.6|2.4|0.0112
71868762|NCT02559895|143254552|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.017|TWO_SIDED|95.0|1.8|17.8|||Cochran-Mantel-Haenszel|||||17.8|1.8|0.0170
71868763|NCT02559895|143254553|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.0001|TWO_SIDED|95.0|9.8|28.0|||Cochran-Mantel-Haenszel|||||28.0|9.8|0.0001
71868764|NCT02559895|143254553|SUPERIORITY||Mean Difference (Final Values)|12.4||||0.0085|TWO_SIDED|95.0|3.2|21.5|||Cochran-Mantel-Haenszel|||||21.5|3.2|0.0085
71868765|NCT02559895|143254553|SUPERIORITY||Mean Difference (Final Values)|12.8||||0.0064|TWO_SIDED|95.0|3.7|22.0|||Cochran-Mantel-Haenszel|||||22.0|3.7|0.0064
71868766|NCT02559895|143254554|SUPERIORITY|||||||0.0159|||||||Cochran-Mantel-Haenszel|||||||0.0159
71868767|NCT02559895|143254554|SUPERIORITY|||||||0.0312|||||||Cochran-Mantel-Haenszel|||||||0.0312
71868768|NCT02559895|143254554|SUPERIORITY|||||||0.1539|||||||Cochran-Mantel-Haenszel|||||||0.1539
71868769|NCT00775463|143254611|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Cochran-Mantel-Haenszel|||A Cochran-Mantel Haenszel mean score test was used on the standardized reverse mid-ranks (overall reverse ranks divided by the number of ranks +1, or modified ridit scores; largely negative changes had ranks near 1 and largely positive changes had ranks near 0)of the residuals from an ordinary least squares regression with change in net ulcer burden at Week 20 as a linear function of Baseline PDEI or prostacyclin use (binary variable:Yes/No) and net ulcer burden at Baseline(continuous variable).||0.0|-1.0|0.20
71868770|NCT00775463|143254612|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-0.4||||0.31|TWO_SIDED|95.0|-1.4|0.4||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.40|-1.40|0.31
71868771|NCT00775463|143254613|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.12|TWO_SIDED|95.0|-21.3|2.7||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||2.7|-21.3|0.12
71868772|NCT00775463|143254614|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.04|TWO_SIDED|95.0|-18.0|0.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.||0.0|-18.0|0.04
71868773|NCT00775463|143254615|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.47|TWO_SIDED|95.0|-4.0|2.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline in CHFS Score were tested using the Wilcoxon rank-sum test.||2.0|-4.0|0.47
71868774|NCT00775463|143254617|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.68|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||he difference between treatment groups for the change from Baseline and at Week 20 in the mRSS was tested using the Wilcoxon rank-sum test.||1.0|0.0|0.68
71868775|NCT00775463|143254618|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.54|TWO_SIDED|95.0|-3.0|2.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||2.0|-3.0|0.54
71868776|NCT00775463|143254618|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Ef|-0.6||||0.18|TWO_SIDED|95.0|-1.6|0.3||P value for Pain VAS|Wilcoxon (Mann-Whitney)|||P value for Pain VAS||0.3|-1.6|0.18
71868777|NCT00775463|143254618|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.1|TWO_SIDED|95.0|-1.0|0.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score||0.0|-1.0|0.10
71868778|NCT00452426|143254633|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||ANOVA|||||||0.028
71868779|NCT00452426|143254635|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANOVA|||||||0.007
71868780|NCT00452426|143254636|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71868781|NCT00091169|143254642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.57
71868782|NCT00091169|143254643|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.64
71868783|NCT00091169|143254644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.93
71912985|NCT00633893|143346039|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.485||||0.3925|TWO_SIDED|95.0|0.0891|2.6391||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.||2.6391|0.0891|0.3925
71912986|NCT00633893|143346039|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2457||||0.3551|TWO_SIDED|95.0|0.0269|2.2437||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.||2.2437|0.0269|0.3551
71912987|NCT00633893|143346040|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2027||||0.5148|TWO_SIDED|95.0|0.6897|2.0975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.0975|0.6897|0.5148
71868784|NCT00091169|143254645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.61
71868785|NCT00091169|143254646|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-05|TWO_SIDED||||||Fisher Exact|||||||0.00001
71868786|NCT00091169|143254647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677|TWO_SIDED||||||Fisher Exact|||||||0.677
71868787|NCT00872989|143254648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.49|TWO_SIDED|80.0|0.79|1.26|||Regression, Cox|||||1.26|0.79|0.49
71868788|NCT00872989|143254650|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.25||||0.83|TWO_SIDED|80.0|0.93|1.68|||Regression, Cox|||||1.68|0.93|0.83
71868789|NCT00852540|143254710|SUPERIORITY_OR_OTHER||percentage of participants|56.9|||||TWO_SIDED|95.0|45.5|68.4|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||68.4|45.5|
71868790|NCT00852540|143254710|SUPERIORITY_OR_OTHER||Percentage of participants|84.2|||||TWO_SIDED|95.0|72.6|95.8|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.|||95.8|72.6|
71868791|NCT01639495|143254721|SUPERIORITY_OR_OTHER||Percentage of subjects|60.6|||||TWO_SIDED|95.0|51.9|68.8|||||The 2-sided 95% confidence intervals are based on exact binomial|||68.8|51.9|
71868792|NCT01639495|143254723|SUPERIORITY_OR_OTHER||Percentage of subjects with primary AEs|17.4|||||TWO_SIDED|95.0|11.6|24.6|||||The 2-sided 95% confidence interval is exact binomial|||24.6|11.6|
71868793|NCT01639495|143254724|SUPERIORITY_OR_OTHER||Percentage of subjects|97.2|||||TWO_SIDED|95.0|95.6|98.2|||||The 2-sided 95% confidence intervals are exact binomial|||98.2|95.6|
71868794|NCT01183234|143254726|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.953|||||TWO_SIDED|90.0|0.915|0.993|||Mixed Models Analysis|||||0.993|0.915|
71868795|NCT01183234|143254727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.988|||||TWO_SIDED|90.0|0.931|1.05|||Mixed Models Analysis|||||1.05|0.931|
71868796|NCT01183234|143254728|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.0|||||TWO_SIDED|90.0|-0.15|0.492|||Wilcoxon (Hodges-Lehmann)|||||0.492|-0.150|
71868797|NCT00704379|143254729|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.6|||<|0.05|TWO_SIDED|95.0|1.1|16.2|||Log Rank|||||16.2|1.1|<0.05
71868798|NCT03292432|143254741|SUPERIORITY||Risk Difference (RD)|-3.5||||0.8|TWO_SIDED|95.0|-21.8|15.2|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 50 copies/mL in TERA arm minus SOC arm|||15.2|-21.8|0.80
71868799|NCT03292432|143254742|SUPERIORITY||Risk Difference (RD)|-0.7|||>|0.99|TWO_SIDED|95.0|-20.9|19.6|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/ml in TERA arm minus SOC arm|||19.6|-20.9|>0.99
71868800|NCT03292432|143254743|SUPERIORITY||Risk Difference (RD)|-13.1||||0.24|TWO_SIDED|95.0|-32.1|7.2|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.2|-32.1|0.24
71868801|NCT03292432|143254743|SUPERIORITY||Risk Difference (RD)|3.8||||0.76|TWO_SIDED|95.0|-16.0|22.6|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||22.6|-16.0|0.76
71868802|NCT03292432|143254743|SUPERIORITY||Risk Difference (RD)|3.6|||>|0.99|TWO_SIDED|95.0|-21.8|27.4|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||27.4|-21.8|>0.99
71868803|NCT03292432|143254744|SUPERIORITY||Risk Difference (RD)|-13.0||||0.26|TWO_SIDED|95.0|-32.7|7.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 24 in TERA arm minus SOC arm|Comparison of percentages at Week 24||7.3|-32.7|0.26
71868804|NCT03292432|143254744|SUPERIORITY||Risk Difference (RD)|11.5||||0.42|TWO_SIDED|95.0|-11.2|32.8|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 36 in TERA arm minus SOC arm|Comparison of percentages at Week 36||32.8|-11.2|0.42
71868805|NCT03292432|143254744|SUPERIORITY||Risk Difference (RD)|-4.4||||0.77|TWO_SIDED|95.0|-29.5|20.7|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 in TERA arm minus SOC arm|Comparison of percentages at Week 48||20.7|-29.5|0.77
71868806|NCT03292432|143254745|SUPERIORITY||Risk Difference (RD)|5.8||||0.67|TWO_SIDED|95.0|-14.6|25.3|||Fisher Exact||Risk difference reflects percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 12 and maintained to Week 48 in TERA arm minus SOC arm|||25.3|-14.6|0.67
71868807|NCT03292432|143254746|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken from Weeks 0 -12||||<0.001
71868808|NCT03292432|143254746|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>12 to 24||||<0.001
71868809|NCT03292432|143254746|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>24 to 36||||0.06
71868810|NCT03292432|143254746|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken from Weeks \>36 to 48||||0.50
71868811|NCT03292432|143254747|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks 0 - 12||||<0.001
71868812|NCT03292432|143254747|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of percentage of doses taken on time from Weeks \>12 - 24||||<0.001
71868813|NCT03292432|143254747|SUPERIORITY|||||||0.05||||||p-value equal to a priori threshold for statistical significance|Wilcoxon (Mann-Whitney)|||Comparison of percentages of doses taken on time from Weeks \>24 - 36||||0.05
71868814|NCT03292432|143254747|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Comparison of doses taken on time from Weeks \>36 - 48||||0.49
71868815|NCT03292432|143254748|SUPERIORITY||Risk Ratio (RR)|2.51|||<|0.001|TWO_SIDED|95.0|1.9|3.33|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks 0 - 12||3.33|1.90|<0.001
71868816|NCT03292432|143254748|SUPERIORITY||Risk Ratio (RR)|1.56|||<|0.001|TWO_SIDED|95.0|1.29|1.89|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>12 - 24||1.89|1.29|<0.001
71868817|NCT03292432|143254748|SUPERIORITY||Risk Ratio (RR)|1.23||||0.02|TWO_SIDED|95.0|1.03|1.47|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|P-value from Pearson Chi-square test from generalized linear model with Poisson link|Comparison of incidence rates from Weeks \>24 - 36||1.47|1.03|0.020
71868818|NCT03292432|143254748|SUPERIORITY||Risk Ratio (RR)|1.08||||0.39|TWO_SIDED|95.0|0.9|1.3|||Chi-squared|Pearson Chi-square test from generalized linear model with Poisson link|Risk ratio for SOC arm relative to TERA arm|Comparison of incidence rates from Weeks \>36 - 48||1.30|0.90|0.39
71868819|NCT03292432|143254749|SUPERIORITY||Risk Difference (RD)|2.3|||>|0.99|TWO_SIDED|95.0|-16.4|21.1|||Fisher Exact||Risk difference reflects percentage of participants achieving HIV-1 RNA \< 200 copies/mL in TERA arm minus SOC arm|||21.1|-16.4|>0.99
71868820|NCT03292432|143254750|SUPERIORITY||Risk Difference (RD)|4.7||||0.71|TWO_SIDED|95.0|-9.0|19.4|||Fisher Exact||Risk difference reflects percentage of participants achieving sustained virologic control in TERA arm minus SOC arm|||19.4|-9.0|0.71
71868821|NCT03699085|143254762|EQUIVALENCE|A p value of \< 0.05 suggests the groups are different.||||||0.38||||||A p value of \< 0.05 suggests the groups are different.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test is used, which ranks the values in each group, sums the ranks and determines the probability that they are the same. The probability p-value is reported.||||0.38
71912988|NCT00633893|143346040|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.616||||0.1412|TWO_SIDED|95.0|0.9554|2.7336||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.||2.7336|0.9554|0.1412
71912989|NCT00633893|143346041|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2928||||0.3932|TWO_SIDED|95.0|0.7158|2.3348||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||2.3348|0.7158|0.3932
71912990|NCT00633893|143346041|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8235||||0.0621||95.0|1.047|3.176||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.||3.1760|1.0470|0.0621
71868822|NCT03699085|143254763|SUPERIORITY|Adjusted mixed effects regression models were used to determine whether patients in the intervention and control group manifested different patterns of change in days of heroin use in the past 30 days in terms of incidence-rate ratio. We applied a negative binomial distribution to help account for overdispersion of outcome data.|Incidence rate ratio|1.29||||0.68|TWO_SIDED|95.0|0.38|4.37||A p value of \< 0.05 suggests the groups are different.|Regression, Cox||A number greater than 1.0 indicates a higher incidence rate of heroin use in past 30 days for intervention group compared to control group|Comparison of control and intervention populations based on substance use measured utilizing a time-line follow back (TLFB) calendar administered by the research assistant to for past 30-day heroin use. This is a covariate-adjusted mixed effects regression model at TLFB timepoint of 6 months. A number greater than 1.0 indicates a higher incidence of heroin use in the past 30 days at the 6 month timepoint for intervention group compared to control group.||4.37|0.38|0.68
71868823|NCT00495586|143254765|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.5|<|0.05|TWO_SIDED|95.0|3.7|24.3|||Chi-squared|||For the comparison of the efficacy of antibiotic versus placebo, we accepted a null hypothesis if the cure rate in the intervention group was the same or ±7% as that observed in the placebo arm. Based on previous studies, the expected rate of cure among patients assigned to antibiotic therapy was 90%. For an alpha of 0.05 and a beta of 0.2 and accepting possible losses of 15%, we calculated that the sample size is 677 patients in total.||24.3|3.7|<0.05
71868824|NCT00158860|143254769|SUPERIORITY||Kaplan-Meier estimates|27.3|||<|0.001|TWO_SIDED|95.0|16.0|38.6|||Log Rank|||||38.6|16.0|<0.001
71868825|NCT00158860|143254769|SUPERIORITY||Hazard Ratio (HR)|0.401|||<|0.001|TWO_SIDED|95.0|0.282|0.57|||Log Rank|||||0.570|0.282|<0.001
71868826|NCT00158860|143254770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon rank sum test|||||||<0.001
71868827|NCT00964886|143254814|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANCOVA|||In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).||||0.7
71868828|NCT00964886|143254815|SUPERIORITY_OR_OTHER|||||||0.84|||||||ANCOVA|Means are adjusted for baseline Roland and Morris scores.||In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.||||0.84
71868829|NCT00964886|143254816|SUPERIORITY_OR_OTHER|||||||0.6|||||||ANCOVA|||||||0.6
71868830|NCT00964886|143254817|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANCOVA|||This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)||||0.8
71868831|NCT04587752|143254821|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||.047
71868832|NCT04587752|143254822|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71868833|NCT04587752|143254823|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71868834|NCT00652327|143254833|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0026|||||||Wilcoxon rank sum test|||||||.0026
71868835|NCT02926898|143254839|SUPERIORITY||Percent difference|-54.0|||<|0.001|TWO_SIDED|95.0|-67.2|-35.6||Analysis of covariance (ANCOVA) model with treatment group (ZX008 or placebo) and age group (\< 6 years, ≥ 6 years) as factors, and with log baseline frequency as a covariate, and log CSF as the outcome variable.|ANCOVA|||||-35.6|-67.2|<0.001
71868836|NCT02926898|143254840|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|A logistic regression model using a categorical response variable as a function of Treatment group, Baseline seizure frequency, and age group.||||||<0.001
71868837|NCT02926898|143254841|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71868838|NCT02224690|143254843|SUPERIORITY||Median Difference (Final Values)|-17.21||||0.0135|TWO_SIDED|95.0|-30.32|-4.09|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-4.09|-30.32|0.0135
71868839|NCT02224690|143254844|SUPERIORITY||Odds Ratio (OR)|2.57||||0.0043|TWO_SIDED|95.0|1.33|4.97|||Cochran-Mantel-Haenszel|Calculated using a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)||||4.97|1.33|0.0043
71868840|NCT02224690|143254845|SUPERIORITY||Mean Difference (Final Values)|-21.13||||0.0005|TWO_SIDED|95.0|-33.26|-9.37|||Wilcoxon rank-sum test||Calculated using the Hodges-Lehmann approach|||-9.37|-33.26|0.0005
71868841|NCT02224690|143254846|SUPERIORITY||Odds Ratio (OR)|2.54||||0.0012|TWO_SIDED|95.0|1.45|4.47|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor.|Odds of participants recording a lower score (improvement) on a continuous scale|||4.47|1.45|0.0012
71682952|NCT01172808|142883968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.067||0.2956|TWO_SIDED|95.0|-0.061|0.201|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.201|-0.061|0.2956
71682953|NCT01172808|142883969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.202|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|-0.318|-0.085|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.085|-0.318|0.0007
71868842|NCT00141219|143254847|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.115||||0.289||95.0|0.785|1.583||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||1.583|0.785|0.289
71868843|NCT00141219|143254848|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.644||||0.041||95.0|0.915|2.954||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.||2.954|0.915|0.041
71868844|NCT00141219|143254849|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.252||0.049||95.0|-1.0|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from the general linear model with treatment and center fitted as factors and the baseline value as a covariate.||Null hypotheses stated there was no difference in pregabalin and placebo in the primary endpoint versus the alternative that there was. The target sample size was 234 subjects (156 and 78 respectively pregabalin vs placebo using a 2:1 ratio). The calculations assumed a 2-sided comparison at 0.05 alpha, 80% power and 3% dropout. Also, a treatment difference of 1 point and a standard deviation for endpoint mean pain scores of 2.5 were assumed based on previous studies.||-0.00|-1.00|0.049
71868845|NCT00141219|143254849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.729||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 1, a treatment by center independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across centers.||||0.729
71868846|NCT00141219|143254849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.979||95.0||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|"In supportive model 2, a treatment by baseline mean pain independent variable added to the main model."||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across different baseline values.||||0.979
71868847|NCT00141219|143254850|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.267||0.077||95.0|-1.0|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center fitted as factors and the baseline value as a covariate.||"Endpoint Mean Pain Score~Pregabalin minus Placebo"||0.05|-1.00|0.077
71868848|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.042||95.0|-0.75|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center, and treatment by week interaction as factors and baseline value as a covariate.||"Mean Pain Score Weeks 1 to 8~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.01|-0.75|0.042
71912991|NCT00633893|143346042|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2579||||0.1691|TWO_SIDED|95.0|0.9064|1.7457||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||1.7457|0.9064|0.1691
71912992|NCT00633893|143346042|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6971||||0.0013|TWO_SIDED|95.0|1.2468|2.3102||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.||2.3102|1.2468|0.0013
71912993|NCT00633893|143346043|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2374||||0.1466|TWO_SIDED|95.0|0.9276|1.6507||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.||1.6507|0.9276|0.1466
71682954|NCT01172808|142883969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|STANDARD_ERROR_OF_MEAN|0.06||0.0262|TWO_SIDED|95.0|-0.25|-0.016|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||-0.016|-0.250|0.0262
71868849|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.071||95.0|-0.79|0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Mean Pain Score~Pregabalin minus Placebo"||0.03|-0.79|0.071
71868850|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.212||0.149||95.0|-0.72|0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Mean Pain Score~Pregabalin minus Placebo"||0.11|-0.72|0.149
71868851|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.213||0.057||95.0|-0.82|0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Mean Pain Score~Pregabalin minus Placebo"||0.01|-0.82|0.057
71868852|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.215||0.044||95.0|-0.85|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Mean Pain Score~Pregabalin minus Placebo"||-0.01|-0.85|0.044
71868853|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.216||0.051||95.0|-0.85|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Mean Pain Score~Pregabalin minus Placebo"||0.00|-0.85|0.051
71682955|NCT01172808|142883970|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.47||||0.0377|TWO_SIDED|95.0|1.02|2.11||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||2.11|1.02|0.0377
71682956|NCT01172808|142883970|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.0022|TWO_SIDED|95.0|1.22|2.54||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||2.54|1.22|0.0022
71868854|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.216||0.178||95.0|-0.72|0.13||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Mean Pain Score~Pregabalin minus Placebo"||0.13|-0.72|0.178
71868855|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.218||0.104||95.0|-0.78|0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Mean Pain Score~Pregabalin minus Placebo"||0.07|-0.78|0.104
71868856|NCT00141219|143254851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.218||0.039||95.0|-0.88|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Mean Pain Score~Pregabalin minus Placebo"||-0.02|-0.88|0.039
71868857|NCT00141219|143254852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.186||0.044||95.0|-0.74|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Duration Adjusted Average Change (DAAC)~Pregabalin minus Placebo"||-0.01|-0.74|0.044
71868858|NCT00141219|143254853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.272||0.018||95.0|-1.19|-0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Sleep Interference Score~Pregabalin minus Placebo"||-0.11|-1.19|0.018
71912994|NCT00633893|143346043|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6468||||0.0005|TWO_SIDED|95.0|1.2552|2.1606||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.||2.1606|1.2552|0.0005
71682957|NCT01172808|142883971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.591|STANDARD_ERROR_OF_MEAN|4.52|<|0.0001|TWO_SIDED|95.0|21.726|39.455|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||39.455|21.726|<0.0001
71682958|NCT01172808|142883971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.66|STANDARD_ERROR_OF_MEAN|4.533|<|0.0001|TWO_SIDED|95.0|14.772|32.549|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||32.549|14.772|<0.0001
71682959|NCT01172808|142883972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.16|STANDARD_ERROR_OF_MEAN|4.447|<|0.0001|TWO_SIDED|95.0|19.44|36.88|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||36.880|19.440|<0.0001
71868859|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.226||0.024||95.0|-0.96|-0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Weeks 1 to 8 Mean Sleep Score~Overall Comparison (8-week average)~Pregabalin minus Placebo"||-0.07|-0.96|0.024
71868860|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.245||0.12||95.0|-0.86|0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Sleep Interference Score~Pregabalin minus Placebo"||0.10|-0.86|0.120
71868861|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.246||0.041||95.0|-0.99|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Sleep Interference Score~Pregabalin minus Placebo"||-0.02|-0.99|0.041
71868862|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.248||0.017||95.0|-1.07|-0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Sleep Interference Score~Pregabalin minus Placebo"||-0.10|-1.07|0.017
71868863|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.249||0.033||95.0|-1.02|-0.04||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Sleep Interference Score~Pregabalin minus Placebo"||-0.04|-1.02|0.033
71868864|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.25||0.078||95.0|-0.93|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Sleep Interference Score~Pregabalin minus Placebo"||0.05|-0.93|0.078
71682960|NCT01172808|142883972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.37|STANDARD_ERROR_OF_MEAN|4.462|<|0.0001|TWO_SIDED|95.0|15.619|33.12|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||33.120|15.619|<0.0001
71868865|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.25||0.038||95.0|-1.01|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.01|0.038
71868866|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.252||0.037||95.0|-1.02|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Sleep Interference Score~Pregabalin minus Placebo"||-0.03|-1.02|0.037
71868867|NCT00141219|143254854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.252||0.015||95.0|-1.11|-0.12||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Sleep Interference Score~Pregabalin minus Placebo"||-0.12|-1.11|0.015
71868868|NCT00141219|143254855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|2.639||0.034||95.0|-10.82|-0.42||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Disturbance~Pregabalin minus Placebo"||-0.42|-10.82|0.034
71868869|NCT00141219|143254856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.05|STANDARD_ERROR_OF_MEAN|3.309||0.128||95.0|-1.47|11.58||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Snoring Score~Pregabalin minus Placebo"||11.58|-1.47|0.128
71868870|NCT00141219|143254857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.887||0.103||95.0|-6.81|0.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Awaken Short of Breath or Headache~Pregabalin minus Placebo"||0.63|-6.81|0.103
71868871|NCT00141219|143254858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.182||0.018||95.0|0.08|0.8||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Quantity~Pregabalin minus Placebo"||0.80|0.08|0.018
71682961|NCT01172808|142883973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.558|STANDARD_ERROR_OF_MEAN|0.603||0.355|TWO_SIDED|95.0|-1.74|0.624|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.624|-1.740|0.3550
71682962|NCT01172808|142883973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58|STANDARD_ERROR_OF_MEAN|0.608||0.0094|TWO_SIDED|95.0|0.388|2.771|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||2.771|0.388|0.0094
71682963|NCT01172808|142883974|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.03||0.0069|TWO_SIDED|95.0|0.022|0.139|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.139|0.022|0.0069
71682964|NCT01172808|142883974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|STANDARD_ERROR_OF_MEAN|0.03||0.081|TWO_SIDED|95.0|-0.006|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.006|0.0810
71682965|NCT01172808|142883975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.031||0.0363|TWO_SIDED|95.0|0.004|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.126|0.004|0.0363
71682966|NCT01172808|142883975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.031||0.2077|TWO_SIDED|95.0|-0.022|0.1|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.100|-0.022|0.2077
71682967|NCT01172808|142883976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.162|STANDARD_ERROR_OF_MEAN|0.14||0.2447|TWO_SIDED|95.0|-0.436|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.111|-0.436|0.2447
71682968|NCT01172808|142883976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.14||0.3046|TWO_SIDED|95.0|-0.131|0.419|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.419|-0.131|0.3046
71868872|NCT00141219|143254859|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23|STANDARD_ERROR_OF_MEAN|0.37||0.504||95.0|0.67|2.24||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Regression, Logistic|OR estimated from model with Optimal sleep status (Yes/No) as response variable, and treatment, baseline Optimal sleep status as explanatory variables|"The OR estimates ratio of Odds of optimal sleep between Pregabalin and Placebo (ie, the former to the latter). Odds of optimal sleep in treatment group is ratio of Probability of having optimal sleep vs Probability of Not having optimal sleep"|"Week 8 Optimal Sleep~Optimal Sleep is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.~Odds ratio measured the odds of optimal sleep in pregabalin to that in placebo.~Standard Error of the Mean equals Standard Error of the Odds Ratio (OR)."||2.24|0.67|.504
71868873|NCT00141219|143254860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|3.796||0.571||95.0|-5.33|9.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Adequacy~Pregabalin minus Placebo"||9.63|-5.33|0.571
71682969|NCT01172808|142883977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.029||0.1178|TWO_SIDED|95.0|-0.011|0.102|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.102|-0.011|0.1178
71682970|NCT01172808|142883977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.029||0.888|TWO_SIDED|95.0|-0.061|0.053|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.||0.053|-0.061|0.8880
71912995|NCT02741310|143346051|OTHER|The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.|LS Mean Difference|-0.04|||||TWO_SIDED|90.0|-2.16|2.08||||||A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.||2.08|-2.16|
71912996|NCT02741310|143346053|OTHER||Geometric Least Squares Mean Ratio|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.03|0.93|
71912997|NCT02741310|143346054|OTHER||Geometric Least Squares Mean Ratio|1.0|||||TWO_SIDED|90.0|0.96|1.05||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.05|0.96|
71912998|NCT02741310|143346055|OTHER||Geometric Least Squares Mean Ratio|0.95|||||TWO_SIDED|90.0|0.82|1.09||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.||1.09|0.82|
71868874|NCT00141219|143254861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|2.349||0.046||95.0|0.08|9.34||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Somnolence~Pregabalin minus Placebo"||9.34|0.08|0.046
71868875|NCT00141219|143254862|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.12|STANDARD_ERROR_OF_MEAN|2.044||0.3||95.0|-6.15|1.91||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Overall Sleep Problem~Pregabalin minus Placebo"||1.91|-6.15|0.300
71868876|NCT00141219|143254863|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.026|STANDARD_ERROR_OF_MEAN|0.0325||0.429||95.0|-0.038|0.09||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Utility Score~Pregabalin minus Placebo"||0.090|-0.038|0.429
71868877|NCT00141219|143254864|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|2.375||0.142||95.0|-1.18|8.18||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint VAS Score~Pregabalin minus Placebo"||8.18|-1.18|0.142
71912999|NCT03417505|143346091|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|Paired t-test comparison||||||<0.01
71913000|NCT03417505|143346092|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparisons, one-sided||||||<0.05
71913001|NCT03417505|143346093|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|paired 1-sided t-test||||||<0.01
71868878|NCT00141219|143254865|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.409||0.038||95.0|-1.66|-0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Anxiety Score~Pregabalin minus Placebo"||-0.05|-1.66|0.038
71868879|NCT00141219|143254866|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.438||0.664||95.0|-1.05|0.67||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Depression Score~Pregabalin minus Placebo"||0.67|-1.05|0.664
71868880|NCT00141219|143254867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.473||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance. p-value is from comparing Pregabalin versus Placebo.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.473
71868881|NCT00141219|143254868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119||95.0||||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.||||0.119
71868882|NCT01506609|143254872|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.227|TWO_SIDED|95.0|0.536|1.162|||Log Rank|||||1.162|0.536|0.227
71868883|NCT01506609|143254872|SUPERIORITY||Hazard Ratio (HR)|1.858||||0.001|TWO_SIDED|95.0|1.278|2.702|||Log Rank|||||2.702|1.278|0.001
71868884|NCT01506609|143254873|SUPERIORITY||Hazard Ratio (HR)|0.848||||0.368|TWO_SIDED|95.0|0.59|1.218|||Log Rank|||||1.218|0.590|0.368
71868885|NCT01506609|143254873|SUPERIORITY||Hazard Ratio (HR)|1.512||||0.017|TWO_SIDED|95.0|1.074|2.127|||Log Rank|||||2.127|1.074|0.017
71868886|NCT01506609|143254874|SUPERIORITY|||||||0.434||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.434
71868887|NCT01506609|143254874|SUPERIORITY|||||||0.019||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.019
71868888|NCT01506609|143254875|SUPERIORITY|||||||0.027||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||0.027
71868889|NCT01506609|143254875|SUPERIORITY||||||<|0.001||||||P-value is from Cochran-Mantel-Haenszel test stratified by estrogen receptor/progesterone receptor status and prior cytotoxic therapy use.|Cochran-Mantel-Haenszel|||||||< 0.001
71913002|NCT03417505|143346094|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparison, one sided p value||||||<0.01
71913003|NCT03417505|143346095|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|t-test, 1 sided|paired||||||>0.05
71913004|NCT03417505|143346096|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
71913005|NCT03417505|143346097|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.01
71913006|NCT03417505|143346098|SUPERIORITY||||||<|0.05||||||Calculated p value was \<0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||<0.05
71913007|NCT03417505|143346099|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided||||||>0.05
71913008|NCT03689972|143346137|SUPERIORITY||Ratio of Mean|4.24|||=|0.0755|TWO_SIDED|95.0|0.86|20.85|||Negative Binomial Regression|The model included treatment as classification variable \& baseline body weight, duration of natalizumab exposure at baseline, \& region as covariates.||||20.85|0.86|=0.0755
71682971|NCT01172808|142883978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.0308|TWO_SIDED|95.0|1.03|1.72||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo|||1.72|1.03|0.0308
71868890|NCT01506609|143254876|SUPERIORITY||Least Squares (LS) Mean of Difference|-2.302|STANDARD_ERROR_OF_MEAN|2.476||0.354|TWO_SIDED|95.0|-7.2|2.6||ANCOVA with treatment arm and baseline value as covariate.|ANCOVA|||||2.60|-7.20|0.354
71868891|NCT00122460|143254877|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.036|TWO_SIDED|95.0|0.644|0.986|||Stratified Log Rank|||"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) \[no vs. yes\] and Karnofsky Performance Status (KPS) \[\<80 vs. ≥80\]).~Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.986|0.644|0.036
71868892|NCT00122460|143254878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.538|||<|0.0001|TWO_SIDED|95.0|0.431|0.672|||Stratified Log Rank|||"To test the equality of PFS between treatment groups, a two-sided stratified log-rank test (α=5%)was used, taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median PFS time was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.672|0.431|<0.0001
71868893|NCT00122460|143254879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.326||||0.0001|TWO_SIDED|95.0|1.504|3.6|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||3.600|1.504|0.0001
71913009|NCT03689972|143346138|SUPERIORITY||Percentage|87.8|||||TWO_SIDED|95.0|80.68|93.01|||Exact Binomial method|Percentage of participants preferring natalizumab SC at end of crossover period of Part 2, and 95% CI was calculated using the exact binomial method.||||93.01|80.68|
71913010|NCT03689972|143346140|SUPERIORITY||Ratio of annualized relapse rate|1.32481|||=|0.6312|TWO_SIDED|95.0|0.42016|4.17725|||Poisson Regression|Poisson regression model was adjusted for baseline body weight, duration of natalizumab exposure at baseline, and region.||||4.17725|0.42016|=0.6312
71913011|NCT03689972|143346146|SUPERIORITY||Difference|0.47|||=|0.764|TWO_SIDED|95.0|-2.61|3.54||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||3.54|-2.61|=0.764
71913012|NCT03689972|143346153|SUPERIORITY||Difference|0.08|||=|0.357|TWO_SIDED|95.0|-0.09|0.25||Performed with factors:route of administration,period,sequence,body weight,duration of natalizumab exposure,stratification factor,baseline TSQM score.|Linear Mixed Effects Model|||||0.25|-0.09|=0.357
71913013|NCT00324272|143346163|SUPERIORITY_OR_OTHER|||||||0.704||95.0|||||t-test, 2 sided|||||||0.704
71913014|NCT00324272|143346163|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||t-test, 2 sided|||||||0.217
71913015|NCT00324272|143346165|SUPERIORITY_OR_OTHER|||||||0.988||95.0|||||t-test, 2 sided|||||||0.988
71913016|NCT00324272|143346165|SUPERIORITY_OR_OTHER|||||||0.426||95.0|||||t-test, 2 sided|||||||0.426
71913017|NCT00324272|143346166|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Fisher Exact|||||||0.351
71913018|NCT00324272|143346166|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Fisher Exact|||||||0.480
71913019|NCT00324272|143346167|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71913020|NCT00324272|143346167|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.400
71913021|NCT00324272|143346168|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||1.00
71913022|NCT00324272|143346168|SUPERIORITY_OR_OTHER|||||||0.301||95.0|||||Fisher Exact|||In transit or regional recurrence in the groin cohort.||||0.301
71913023|NCT00324272|143346168|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||Fisher Exact|||Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.474
71913024|NCT00324272|143346168|SUPERIORITY_OR_OTHER|||||||0.606||95.0|||||Fisher Exact|||Local recurrence in the groin cohort.||||0.606
71868894|NCT00122460|143254880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.881|||<|0.0001|TWO_SIDED|95.0|1.87|4.441|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.||4.441|1.870|<0.0001
71868895|NCT00122460|143254881|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.593|||<|0.0001|TWO_SIDED|95.0|0.484|0.727|||Stratified Log Rank|||"Treatment groups were compared applying a two-sided stratified log-rank test (α=5%), taking into account strata used for randomization (previous CTX \[yes/no\] and KPS \[\<80 vs. ≥80\]).~Median time to treatment failure was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||0.727|0.484|<0.0001
71868896|NCT00122460|143254882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.762||||0.21|TWO_SIDED|95.0|0.497|1.168|||Stratified Log Rank|||"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX \[no vs. yes\] and KPS \[\<80 vs. ≥80\]).~Median duration of response was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."||1.168|0.497|0.21
71868897|NCT02595073|143254886|SUPERIORITY|||||||0.3353|||||||z-test, 2-tailed|||||||0.3353
71868898|NCT02595073|143254887|SUPERIORITY|||||||0.619|||||||ANCOVA|||||||0.6190
71868899|NCT03143166|143254939|OTHER||Adjusted gMean ratio Test/Reference (%)|28.85|STANDARD_ERROR_OF_MEAN|86.7|||TWO_SIDED|90.0|21.346|38.996|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||38.996|21.346|
71868900|NCT03143166|143254940|OTHER||Adjusted gMean ratio Test/Reference (%)|26.37|STANDARD_ERROR_OF_MEAN|76.6|||TWO_SIDED|90.0|20.066|34.665|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||34.665|20.066|
71868901|NCT03143166|143254941|OTHER||Adjusted gMean ratio Test/Reference (%)|28.02|STANDARD_ERROR_OF_MEAN|83.4|||TWO_SIDED|90.0|20.914|37.537|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||37.537|20.914|
71913025|NCT00324272|143346168|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||In transit or regional recurrence in the axillary cohort.||||1.000
71868902|NCT03143166|143254942|OTHER||Adjusted gMean ratio Test/Reference (%)|27.56|STANDARD_ERROR_OF_MEAN|75.6|||TWO_SIDED|90.0|21.023|36.118|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||36.118|21.023|
71868903|NCT03143166|143254943|OTHER||Adjusted gMean ratio Test/Reference (%)|30.59|STANDARD_ERROR_OF_MEAN|76.8|||TWO_SIDED|90.0|23.26|40.234|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.234|23.260|
71868904|NCT03143166|143254944|OTHER||Adjusted gMean ratio Test/Reference (%)|30.61|STANDARD_ERROR_OF_MEAN|74.9|||TWO_SIDED|90.0|23.404|40.037|||ANOVA|An analysis of variance (ANOVA) was used on the logarithmic scale including effects for 'subjects' and 'treatment'.|The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).|||40.037|23.404|
71868905|NCT05326815|143254980|OTHER|Spearman Correlation.|||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71868906|NCT02545933|143254987|SUPERIORITY||least square mean difference|27.0||||0.011|TWO_SIDED|95.0|19.0|34.0|||ANOVA||DAPT group vs DAPT plus vorapaxar group|We hypothesized that adjunctive vorapaxar would result in a significant reduction of CAT-induced platelet aggregation. Assuming a 10% absolute reduction in CAT-induced maximal platelet aggregation with a common standard deviation of 13%, 37 patients per group with valid primary endpoint data were required to detect a significant difference with a 90% power and 2-sided alpha=0.05.||34|19|0.011
71868907|NCT00935818|143254990|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.03|TWO_SIDED|95.0|1.05|2.12|||Regression, Logistic|||Logistic regression with covariate included for study site.||2.12|1.05|0.03
71868908|NCT00935818|143254991|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.03|TWO_SIDED|95.0|1.04|2.22|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.22|1.04|0.03
71868909|NCT00935818|143254992|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||< 0.001
71868910|NCT00935818|143254993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.93|||Regression, Logistic|||Logistic regression adjusted for study site||1.93|0.95|0.09
71868911|NCT00935818|143254994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.14|TWO_SIDED|95.0|0.91|1.91|||Regression, Logistic|||Logistic Regression adjusting for study site||1.91|0.91|0.14
71913026|NCT00324272|143346168|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).||||0.486
71913027|NCT00324272|143346169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.963|TWO_SIDED|95.0|0.4|2.58|||Regression, Cox|||Death from metastatic disease in the groin cohort.||2.58|0.40|0.963
71913028|NCT00324272|143346169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.338|TWO_SIDED|95.0|0.03|3.2|||Regression, Cox|||Death from an unrelated cause in the groin cohort.||3.20|0.03|0.338
71913029|NCT00324272|143346169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.88|TWO_SIDED|95.0|0.35|2.47|||Regression, Cox|||Death from metastatic disease in the axillary cohort.||2.47|0.35|0.880
71913030|NCT00324272|143346169|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.923||||0.923|TWO_SIDED|95.0|0.05|13.95|||Regression, Cox|||Death from an unrelated cause in the axillary cohort.||13.95|0.05|0.923
71913031|NCT02417064|143346170|SUPERIORITY||Difference of Least Square (LS) Means|-3.2||||0.088|TWO_SIDED|95.0|-6.88|0.45|||Mixed Model for Repeated Measures|||||0.45|-6.88|0.088
71913032|NCT02417064|143346170|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.67|-0.49||||||||-0.49|-7.67|
71913033|NCT02417064|143346171|SUPERIORITY||Difference of Least Square (LS) Means|-2.0|||=|0.25|TWO_SIDED|95.0|-5.52|1.42|||ANCOVA|||||1.42|-5.52|= 0.250
71682972|NCT01172808|142883978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.0348|TWO_SIDED|95.0|1.02|1.71||Calculated as 2\*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|||1.71|1.02|0.0348
71868912|NCT00935818|143254995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.11|TWO_SIDED|95.0|0.93|2.07|||Regression, Logistic|||Logistic Regression - adjusting for study site||2.07|0.93|0.11
71868913|NCT00935818|143254996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.08|TWO_SIDED|95.0|0.96|2.05|||Regression, Logistic|||Logistic Regression - adjusting for site||2.05|0.96|0.08
71868914|NCT01846494|143255009|OTHER|||||||0.6173|||||||Log Rank|||||||0.6173
71868915|NCT05180500|143255010|OTHER|||||||0.7|||||||Fisher Exact|||||||.70
71868916|NCT05180500|143255011|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
71868917|NCT05180500|143255014|OTHER|||||||0.28|||||||Fisher Exact|||||||0.28
71868918|NCT05180500|143255015|OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.60
71868919|NCT05180500|143255016|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
71868920|NCT05180500|143255017|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
71868921|NCT05180500|143255018|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Concentrations that were below the lower limit of quantification (\<15 ng/mL) were set to 7.5 ng/mL for analyses.||||<.001
71868922|NCT05180500|143255019|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71868923|NCT02317432|143255027|SUPERIORITY||Slope|-0.12|||<|0.01|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.01
71868924|NCT02317432|143255028|SUPERIORITY||Slope|0.6||||0.03|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.03
71868925|NCT02317432|143255029|SUPERIORITY||Slope|6.0||||0.02|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.02
71868926|NCT02317432|143255030|SUPERIORITY||Slope|-1.24||||0.15|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.15
71868927|NCT02317432|143255031|SUPERIORITY||Slope|-0.49||||0.35|TWO_SIDED|||||Threshold for statistical significance was p\<0.05|Mixed Models Analysis|||||||0.35
71868928|NCT03992846|143255041|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|2.56|||<|0.001|TWO_SIDED|97.5|1.46|4.49|||Bonferroni-corrected p-value|||||4.49|1.46|<0.001
71868929|NCT03992846|143255041|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 1.10 or greater from baseline pain for Dysmenorrhea (DYS).|Odds Ratio (OR)|8.8|||<|0.001|TWO_SIDED|97.5|4.86|15.91|||Bonferroni-corrected p-value|||||15.91|4.86|<0.001
71868930|NCT03992846|143255042|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|1.43||||0.279|TWO_SIDED|97.5|0.83|2.45|||Bonferroni-corrected p-value|||||2.45|0.83|0.279
71868931|NCT03992846|143255042|OTHER|The criterion for defining a subject as a responder over the last 28 days of randomized treatment up to Month 3 was a reduction of 0.80 or greater from baseline pain for Non-Menstrual Pelvic Pain (NMPP).|Odds Ratio (OR)|2.01||||0.007|TWO_SIDED|97.5|1.18|3.42|||Bonferroni-corrected p-value|||||3.42|1.18|0.007
71868932|NCT03541174|143255075|SUPERIORITY||LS Mean difference to placebo|-3.79||||0.0042|TWO_SIDED|97.5|-6.76|-0.82||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.82|-6.76|0.0042
71868933|NCT03541174|143255075|SUPERIORITY||LS Mean difference to placebo|-3.73||||0.0046|TWO_SIDED|97.5|-6.67|-0.78||Mixed effects model for Repeated Measures: Change from baseline in SiSBP = baseline SiSBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-0.78|-6.67|0.0046
71868934|NCT03541174|143255076|SUPERIORITY||LS mean difference to placebo.|-5.82|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.71||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiSBP = DB-WD baseline SiSBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + DB-WD baseline x visit.|Mixed Models Analysis|||||-3.71|-7.94|<0.0001
71868935|NCT03541174|143255077|OTHER||LS Mean difference to placebo|-3.94|||<|0.0001|TWO_SIDED|95.0|-5.57|-2.31||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.31|-5.57|<0.0001
71682973|NCT01010009|142883983|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||>0.05
71682974|NCT01010009|142883983|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.||||<0.05
71868936|NCT03541174|143255077|OTHER||LS Mean difference to placebo|-4.47|||<|0.0001|TWO_SIDED|95.0|-6.09|-2.85||Mixed effects model for Repeated Measures: Change from baseline in SiDBP = baseline SiDBP + treatment + visit + treatment x visit + baseline x visit.|Mixed Models Analysis|||||-2.85|-6.09|<0.0001
71868937|NCT03541174|143255078|OTHER||LS Mean difference to placebo|-4.18|||<|0.0001|TWO_SIDED|95.0|-6.25|-2.12|||ANCOVA|||24-hour mean systolic (SBP)||-2.12|-6.25|<0.0001
71868938|NCT03541174|143255078|OTHER||LS Mean difference to placebo|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.94|-3.85|||ANCOVA|||24-hour mean systolic (SBP)||-3.85|-7.94|<0.0001
71868939|NCT03541174|143255078|OTHER||LS Mean difference to placebo|-4.32|||<|0.0001|TWO_SIDED|95.0|-5.66|-2.98|||ANCOVA|||24-hour mean diastolic (DBP)||-2.98|-5.66|<0.0001
71868940|NCT03541174|143255078|OTHER||LS Mean|-5.81|||<|0.0001|TWO_SIDED|95.0|-7.14|-4.49|||ANCOVA|||24-hour mean diastolic (DBP)||-4.49|-7.14|<0.0001
71868941|NCT03541174|143255079|OTHER||LS Mean difference to placebo|-5.19|||<|0.0001|TWO_SIDED|95.0|-6.62|-3.76||Mixed effects model for Repeated Measures: Change from DB-WD baseline in SiDBP = Double-blind withdrawal baseline SiDBP + stratum (randomized treatment in DB part) + treatment + visit + treatment x visit + Double-blind withdrawal baseline x visit.|Mixed Models Analysis|||||-3.76|-6.62|<0.0001
71682975|NCT01010009|142883984|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
71682976|NCT01010009|142883984|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.||||>0.05
71868942|NCT03541174|143255080|OTHER||LS Mean difference to placebo|-6.53|||<|0.0001|TWO_SIDED|95.0|-8.5|-4.56|||ANCOVA|||24-hour mean systolic (SBP)||-4.56|-8.50|<0.0001
71868943|NCT03541174|143255080|OTHER||LSM Mean difference to placebo|-6.75|||<|0.0001|TWO_SIDED|95.0|-7.98|-5.52|||ANCOVA|||24-hour mean diastolic (DBP)||-5.52|-7.98|<0.0001
71868944|NCT02217332|143255083|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 6 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'.||||< 0.001
71868945|NCT02217332|143255084|SUPERIORITY|||||||0.885||||||Month 6/LOCF was used for the analysis of change from Baseline to Month 6 within the dexpramipexole group.|t-test, 2 sided|||||||0.885
71868946|NCT02217332|143255088|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Paired t-test comparing baseline to month 3 on log scale within the dexpramipexole treatment group.||Null hypothesis is the ratio of Month 3 to Baseline within the dexpramipexole group equals '1'.||||<.001
71868947|NCT02217332|143255089|SUPERIORITY|||||||1||||||Month 3/LOCF was used for the analysis of change from Baseline to Month 3 within the dexpramipexole group.|t-test, 2 sided|Paired t-test comparing baseline to month 3 within the dexpramipexole treatment group||||||1.0
71868948|NCT02217332|143255090|SUPERIORITY||log scale|||||0.001|||||||Wilcoxon Signed Rank Test (paired)|||Null hypothesis is the ratio of Month 6 to Baseline within the dexpramipexole group equals '1'; 68% confidence interval is equal to plus/minus 1 standard error||||0.001
71868949|NCT03730480|143255115|OTHER|count of number of results within 15% of reference analyzer||||||||||||||||count of number of responses|The number of results that are within 15% of reference analyzer is reported.|||
71913034|NCT02417064|143346171|SUPERIORITY||Difference of Least Square (LS) Means|-4.1|||||TWO_SIDED|95.0|-7.53|-0.6||||||||-0.6|-7.53|
71868950|NCT02480153|143255117|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if the 2-sided 95% CI fell within (-14%, 14%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|95.0|-10.38|4.44||||||||4.44|-10.38|
71868951|NCT02480153|143255117|NON_INFERIORITY_OR_EQUIVALENCE|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if 2-sided 90% CI fell within (-12%, 15%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||TWO_SIDED|90.0|-9.25|3.28||||||||3.28|-9.25|
71868952|NCT00007345|143255180|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.|Cochran-Armitage trend test|||||||<0.01
71868953|NCT04433585|143255185|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
71868954|NCT04433585|143255185|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
71868955|NCT04433585|143255185|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
71868956|NCT04433585|143255186|SUPERIORITY||Odds Ratio (OR)|1.89||||0.131|TWO_SIDED|95.0|0.83|4.3|||Regression, Logistic|||||4.30|0.83|0.131
71682977|NCT01010009|142883985|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
71682978|NCT01010009|142883985|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.||||<0.05
71682979|NCT05459558|142884013|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71682980|NCT05459558|142884013|SUPERIORITY||||||<|0.0001||||||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71682981|NCT05459558|142884014|SUPERIORITY||||||<|0.0001|||||||Mixed Models with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71682982|NCT05459558|142884014|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Test for non-zero within group change from Baseline.||||<0.0001
71868957|NCT04433585|143255186|SUPERIORITY||Odds Ratio (OR)|1.09||||0.844|TWO_SIDED|95.0|0.47|2.5|||Regression, Logistic|||||2.50|0.47|0.844
71913035|NCT00371540|143346186|SUPERIORITY_OR_OTHER|||||||0.65|||||||Fisher Exact|||Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.||||0.65
71913036|NCT00371540|143346187|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71913037|NCT00371540|143346188|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71868958|NCT04433585|143255186|SUPERIORITY||Odds Ratio (OR)|0.57||||0.218|TWO_SIDED|95.0|0.24|1.39|||Regression, Logistic|||||1.39|0.24|0.218
71868959|NCT04433585|143255187|SUPERIORITY||Odds Ratio (OR)|0.97||||0.944|TWO_SIDED|95.0|0.47|2.03|||Regression, Logistic|||||2.03|0.47|0.944
71868960|NCT04433585|143255187|SUPERIORITY||Odds Ratio (OR)|1.46||||0.309|TWO_SIDED|95.0|0.7|3.04|||Regression, Logistic|||||3.04|0.70|0.309
71868961|NCT04433585|143255187|SUPERIORITY||Odds Ratio (OR)|0.84||||0.649|TWO_SIDED|95.0|0.4|1.78|||Regression, Logistic|||||1.78|0.40|0.649
71868962|NCT04433585|143255188|SUPERIORITY||Odds Ratio (OR)|1.91||||0.203|TWO_SIDED|95.0|0.71|5.2|||Regression, Logistic|||||5.20|0.71|0.203
71868963|NCT04433585|143255188|SUPERIORITY||Odds Ratio (OR)|1.1||||0.865|TWO_SIDED|95.0|0.38|3.16|||Regression, Logistic|||||3.16|0.38|0.865
71868964|NCT04433585|143255188|SUPERIORITY||Odds Ratio (OR)|1.07||||0.896|TWO_SIDED|95.0|0.38|3.05|||Regression, Logistic|||||3.05|0.38|0.896
71868965|NCT02342743|143255190|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71868966|NCT02342743|143255191|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71868967|NCT02342743|143255192|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71868968|NCT02342743|143255193|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71868969|NCT02342743|143255194|SUPERIORITY|||||||0.012||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.012
71868970|NCT02342743|143255195|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71868971|NCT02342743|143255197|SUPERIORITY|||||||0.03||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)|||||||0.030
71913038|NCT01548417|143346190|SUPERIORITY_OR_OTHER|||||||0.003|||||||Mixed Models Analysis|||Linear Mixed Effects Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in alcohol-cued craving..||||.003
71682983|NCT05459558|142884015|SUPERIORITY||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.88|-1.62|||Mixed Model with Repeated Measures|||Week 4||-1.62|-1.88|<0.0001
71868972|NCT02937454|143255209|OTHER||Annualised event rate ratio (RR)|0.79||||0.059|TWO_SIDED|95.0|0.62|1.01|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.01|0.62|0.059
71868973|NCT02937454|143255209|OTHER||Annualised event rate ratio (RR)|0.75||||0.024|TWO_SIDED|95.0|0.59|0.96|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Covid-19 Sensitivity Analysis||0.96|0.59|0.024
71868974|NCT02937454|143255210|OTHER||Annualised event rate ratio (RR)|0.8||||0.05|TWO_SIDED|95.0|0.64|1.0|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||1.0|0.64|0.050
71868975|NCT02937454|143255210|OTHER||Annualised event rate ratio (RR)|0.77||||0.024|TWO_SIDED|95.0|0.62|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.97|0.62|0.024
71868976|NCT02937454|143255211|OTHER||Annualised event rate ratio (RR)|0.74||||0.013|TWO_SIDED|95.0|0.58|0.94|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.94|0.58|0.013
71868977|NCT02937454|143255211|OTHER||Annualised event rate ratio (RR)|0.7||||0.005|TWO_SIDED|95.0|0.55|0.9|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||COVID-19 sensitivity analyses||0.90|0.55|0.005
71868978|NCT02937454|143255212|OTHER||Hazard Ratio (HR)|0.96||||0.809|TWO_SIDED|95.0|0.7|1.32|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||1.32|0.70|0.809
71868979|NCT02937454|143255212|OTHER||Hazard Ratio (HR)|0.94||||0.687|TWO_SIDED|95.0|0.68|1.29|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||1.29|0.68|0.687
71868980|NCT02937454|143255213|OTHER||Hazard Ratio (HR)|0.8||||0.03|TWO_SIDED|95.0|0.66|0.98|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||0.98|0.66|0.030
71868981|NCT02937454|143255213|OTHER||Hazard Ratio (HR)|0.79||||0.023|TWO_SIDED|95.0|0.65|0.97|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Covid-19 Sensitivity Analysis||0.97|0.65|0.023
71868982|NCT02937454|143255214|OTHER||Annualised event rate ratio (RR)|0.67||||0.035|TWO_SIDED|95.0|0.47|0.97|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country.||Full Analysis Set (FAS)||0.97|0.47|0.035
71868983|NCT02937454|143255214|OTHER||Annualised event rate ratio (RR)|0.61||||0.009|TWO_SIDED|95.0|0.42|0.88|||Negative binomial model|Negative binomial model adjusted for baseline covariates: sex, age, HF aetiology, HF duration, and country||Covid-19 Sensitivity Analysis||0.88|0.42|0.009
71868984|NCT02937454|143255215|OTHER||Hazard Ratio (HR)|0.73||||0.006|TWO_SIDED|95.0|0.59|0.92|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.92|0.59|0.006
71868985|NCT02937454|143255216|OTHER||Hazard Ratio (HR)|0.77||||0.009|TWO_SIDED|95.0|0.63|0.94|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline.||Full Analysis Set (FAS)||0.94|0.63|0.009
71868986|NCT02937454|143255217|OTHER||Hazard Ratio (HR)|0.99||||0.944|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|Cox regression adjusted for sex, age, HF aetiology, HF duration, and country at baseline||Full Analysis Set (FAS)||1.31|0.75|0.944
71913039|NCT01548417|143346191|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||Linear Mixed Effect Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in changes in drinking.||||.05
71913040|NCT01548417|143346191|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||Data represent the estimated marginal mean + or - SEM. \*P\<0.05, mifepristone vs. placebo (linear mixed effects modeling).||||<0.05
71913041|NCT04583969|143346195|SUPERIORITY||Odds Ratio (OR)|1.13||||0.691|TWO_SIDED|95.0|0.63|2.02|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||2.02|0.63|0.691
71868987|NCT02937454|143255218|OTHER||Odds Ratio (OR)|1.14||||0.196|TWO_SIDED|95.0|0.93|1.39|||Generalised Estimating Equations (GEE)|The following variables are included in the GEE model: treatment, visit, baseline NYHA class, sex, age, HF aetiology, HF duration, and country||Full Analysis Set (FAS)||1.39|0.93|0.196
71868988|NCT02937454|143255219|OTHER|||||||0.208|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.208
71868989|NCT02937454|143255219|OTHER|||||||0.408|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.408
71868990|NCT02937454|143255219|OTHER|||||||0.999|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.999
71868991|NCT02937454|143255220|OTHER|||||||0.227|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 2||||0.227
71868992|NCT02937454|143255220|OTHER|||||||0.018|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 4||||0.018
71868993|NCT02937454|143255220|OTHER|||||||0.005|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 6||||0.005
71868994|NCT02937454|143255220|OTHER|||||||0.006|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 12||||0.006
71868995|NCT02937454|143255220|OTHER|||||||0.028|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 24||||0.028
71868996|NCT02937454|143255220|OTHER|||||||0.136|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 36||||0.136
71868997|NCT02937454|143255220|OTHER|||||||0.329|||||||Mixed-effect model of repeated measures|MMRM using unstructured covariance matrix: Change score = Baseline score + Treatment + Visit + Treatment\*Visit + Baseline covariates.||Week 52||||0.329
71868998|NCT02630693|143255221|OTHER|As stated in the protocol, the primary objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for progression free survival.|Hazard Ratio (HR)|0.93|||||TWO_SIDED|90.0|0.66|1.3|||||Hazard ratio of Palbociclib100mg arm vs 125 mg arm|||1.30|0.66|
71868999|NCT02630693|143255224|OTHER|As stated in the protocol, the objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for overall survival.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|90.0|0.67|1.69|||||Hazard ratio for Palbociclib 100mg arm vs 125 mg arm|||1.69|0.67|
71682984|NCT05459558|142884015|SUPERIORITY||Mean Difference (Final Values)|-1.74|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-1.87|-1.61|||Mixed Model with Repeated Measures|||Week 4||-1.61|-1.87|<0.0001
71869000|NCT01639560|143255241|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.7|||<|0.001|TWO_SIDED|95.0|2.5|18.1|||Regression, Logistic|||||18.1|2.5|<0.001
71869001|NCT01639560|143255242|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.001|TWO_SIDED|95.0|2.2|24.0|||Regression, Logistic|||||24.0|2.2|0.001
71869002|NCT01639560|143255243|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.047|TWO_SIDED|95.0|1.0|6.3|||Regression, Logistic|||||6.3|1.0|0.047
71869003|NCT01639560|143255244|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.009|TWO_SIDED|95.0|1.5|16.5|||Regression, Logistic|||||16.5|1.5|0.009
71869004|NCT01160289|143255245|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.5
71869005|NCT01160289|143255245|SUPERIORITY_OR_OTHER|||||||0.498||95.0||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp\*baseline IIEF, tx grp\*testosterone level interactions.||Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.||||0.498
71869006|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.178|STANDARD_ERROR_OF_MEAN|3.312||0.722||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.722
71869007|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.552|STANDARD_ERROR_OF_MEAN|3.253||0.634||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.634
71913042|NCT04583969|143346196|SUPERIORITY||Odds Ratio (OR)|1.24||||0.378|TWO_SIDED|95.0|0.77|1.99|||Regression, Logistic||Odds ratio above 1 favors Remdesivir plus Lenzilumab.|Odds ratio, CI, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline OS, age (continuous), and baseline CRP. Missing data imputed using the 3-stage multiple imputation procedure described in the statistical analysis plan.||1.99|0.77|0.378
71869008|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-4.674|STANDARD_ERROR_OF_MEAN|3.218||0.147||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.147
71869009|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.404|STANDARD_ERROR_OF_MEAN|3.157||0.02||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.020
71869010|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.33|STANDARD_ERROR_OF_MEAN|4.658||0.775||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.775
71869011|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|1.844|STANDARD_ERROR_OF_MEAN|4.573||0.687||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.687
71869012|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.092|STANDARD_ERROR_OF_MEAN|4.535||0.119||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.119
71869013|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-6.578|STANDARD_ERROR_OF_MEAN|4.45||0.14||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.140
71869014|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|6.703|STANDARD_ERROR_OF_MEAN|5.302||0.207||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.207
71869015|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|9.159|STANDARD_ERROR_OF_MEAN|5.206||0.079||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.079
71869016|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-5.349|STANDARD_ERROR_OF_MEAN|5.165||0.301||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.301
71869017|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-2.893|STANDARD_ERROR_OF_MEAN|5.067||0.568||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.568
71869018|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.079|STANDARD_ERROR_OF_MEAN|5.566||0.464||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.464
71869019|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.054|STANDARD_ERROR_OF_MEAN|5.463||0.356||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.356
71869020|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-11.266|STANDARD_ERROR_OF_MEAN|5.418||0.038||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.038
71869021|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-10.292|STANDARD_ERROR_OF_MEAN|5.312||0.054||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.054
71869022|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|4.202|STANDARD_ERROR_OF_MEAN|5.603||0.454||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.454
71869023|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|5.796|STANDARD_ERROR_OF_MEAN|5.499||0.293||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.293
71869024|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-8.808|STANDARD_ERROR_OF_MEAN|5.457||0.107||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.107
71869025|NCT01160289|143255246|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-7.214|STANDARD_ERROR_OF_MEAN|5.349||0.178||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis|||||||0.178
71869026|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.079|STANDARD_ERROR_OF_MEAN|0.472||0.867||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.867
71869027|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.039|STANDARD_ERROR_OF_MEAN|0.458||0.931||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.931
71869028|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.652|STANDARD_ERROR_OF_MEAN|0.46||0.158||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.158
71869029|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.612|STANDARD_ERROR_OF_MEAN|0.447||0.172||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.172
71869030|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.223|STANDARD_ERROR_OF_MEAN|0.401||0.579||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.579
71869031|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.616|STANDARD_ERROR_OF_MEAN|0.39||0.115||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.115
71869032|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.168|STANDARD_ERROR_OF_MEAN|0.392||0.668||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.668
71869033|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.561|STANDARD_ERROR_OF_MEAN|0.38||0.141||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.141
71869034|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.088|STANDARD_ERROR_OF_MEAN|0.258||0.734||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.734
71869035|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.179|STANDARD_ERROR_OF_MEAN|0.251||0.477||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.477
71869036|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.3|STANDARD_ERROR_OF_MEAN|0.252||0.235||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.235
71869037|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.391|STANDARD_ERROR_OF_MEAN|0.245||0.111||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.111
71869038|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.349|STANDARD_ERROR_OF_MEAN|0.343||0.31||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.310
71869039|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.568|STANDARD_ERROR_OF_MEAN|0.334||0.09||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.090
71869040|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.729|STANDARD_ERROR_OF_MEAN|0.335||0.03||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.030
71682985|NCT05459558|142884015|SUPERIORITY||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.08|-1.81||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.81|-2.08|<0.0001
71682986|NCT05459558|142884015|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001|TWO_SIDED|95.0|-2.18|-1.9||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.90|-2.18|<0.0001
71869041|NCT01160289|143255247|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.948|STANDARD_ERROR_OF_MEAN|0.326||0.004||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.004
71869042|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.656||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.656
71869043|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.46||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.460
71869044|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level \<340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.198
71869045|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.009
71682987|NCT05459558|142884016|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-1.0|-0.62|||Mixed Model with Repeated Measures|||Week 4||-0.62|-1.00|<0.0001
71869046|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.671||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.671
71869047|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.259||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.259
71869048|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.441||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.441
71869049|NCT01160289|143255249|SUPERIORITY_OR_OTHER|||||||0.433||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA|||||||0.433
71869050|NCT01160289|143255250|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.13||||0.423||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.423
71869051|NCT01160289|143255250|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.12||||0.443||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.443
71869052|NCT01160289|143255250|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.084||||0.599||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.599
71869053|NCT01160289|143255250|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.334||||0.029||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.029
71869054|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.152||||0.148||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.148
71869055|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.216||||0.033||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.033
71869056|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.124||||0.224||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.224
71869057|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.189||||0.056||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.056
71869058|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.211||||0.031||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.031
71869059|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.227||||0.017||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.017
71682988|NCT05459558|142884016|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.097|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41|||Mixed Model with Repeated Measures|||Week 4||-0.41|-0.79|<0.0001
71869060|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.016||||0.866||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.866
71869061|NCT01160289|143255251|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.032||||0.726||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.726
71869062|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-9.014|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71869063|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.547|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71869064|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-9.216|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71869065|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-18.75|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||<0.001
71869066|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.977||||0.776||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
71869067|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.78||||0.814||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.814
71869068|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.629||||0.627||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.627
71869069|NCT01160289|143255252|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.128||||0.968||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.968
71869070|NCT01160289|143255253|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|-0.006||||0.984||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.984
71869071|NCT01160289|143255253|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.465||||0.076||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.076
71869072|NCT01160289|143255253|SUPERIORITY_OR_OTHER||LS mean of treatment difference|0.387||||0.142||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.142
71869073|NCT01160289|143255253|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-0.072||||0.776||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.776
71869074|NCT01160289|143255254|SUPERIORITY_OR_OTHER||LS Mean of treatment difference|5.031||||0.103||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.103
71869075|NCT01160289|143255254|SUPERIORITY_OR_OTHER||LS mean treatment difference|-3.225||||0.277||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.277
71869076|NCT01160289|143255254|SUPERIORITY_OR_OTHER||LS mean of treatment difference|7.056||||0.019||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.019
71869077|NCT01160289|143255254|SUPERIORITY_OR_OTHER||LS mean of treatment difference|-1.201||||0.676||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis|||||||0.676
71869078|NCT04193436|143255272|OTHER||Ratio (%) of Adjusted Means|92.89|||||TWO_SIDED|90.0|68.15|126.6||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way analysis of variance (ANOVA) model based on natural log transformed data.||126.60|68.15|
71869079|NCT04193436|143255272|OTHER||Ratio (%) of Adjusted Means|134.4|||||TWO_SIDED|90.0|98.61|183.17||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||183.17|98.61|
71869080|NCT04193436|143255272|OTHER||Ratio (%) of Adjusted Means|139.33|||||TWO_SIDED|90.0|100.69|192.78||||||The effect of the hepatic impairment on PK parameter AUCinf were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||192.78|100.69|
71869081|NCT04193436|143255273|OTHER||Ratio (%) of Adjusted Means|87.2|||||TWO_SIDED|90.0|63.61|119.53||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||119.53|63.61|
71869082|NCT04193436|143255273|OTHER||Ratio (%) of Adjusted Means|102.24|||||TWO_SIDED|90.0|74.59|140.15||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||140.15|74.59|
71869083|NCT04193436|143255273|OTHER||Ratio (%) of Adjusted Means|83.78|||||TWO_SIDED|90.0|60.18|116.62||||||The effect of the hepatic impairment on PK parameter Cmax were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||116.62|60.18|
71913043|NCT04583969|143346197|SUPERIORITY|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline CRP.|Hazard Ratio, log|0.96||||0.689|TWO_SIDED|95.0|0.76|1.2|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|||1.20|0.76|0.689
71682989|NCT05459558|142884016|SUPERIORITY||Mean Difference (Final Values)|-1.68|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-2.06|-1.31||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.31|-2.06|<0.0001
71682990|NCT05459558|142884016|SUPERIORITY||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.191|<|0.0001|TWO_SIDED|95.0|-2.19|-1.44||p-value adjusted for multiplicity using Graphical Approach.|Mixed Model with Repeated Measures|||Week 8||-1.44|-2.19|<0.0001
71869084|NCT04193436|143255274|OTHER||Ratio (%) of Adjusted Means|121.81|||||TWO_SIDED|90.0|88.69|167.31||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||167.31|88.69|
71869085|NCT04193436|143255274|OTHER||Ratio (%) of Adjusted Means|178.5|||||TWO_SIDED|90.0|129.96|245.18||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||245.18|129.96|
71869086|NCT04193436|143255274|OTHER||Ratio (%) of Adjusted Means|195.73|||||TWO_SIDED|90.0|140.31|273.03||||||The effect of the hepatic impairment on PK parameter AUCinf,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||273.03|140.31|
71869087|NCT04193436|143255275|OTHER||Ratio (%) of Adjusted Means|114.45|||||TWO_SIDED|90.0|88.13|148.63||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||148.63|88.13|
71913044|NCT04583969|143346198|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.718|TWO_SIDED|95.0|0.79|1.18|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab.|Hazard ratio, confidence intervals, and p-value estimated from a Cox model adjusted for baseline dexamethasone use, baseline ordinal Score, age, and baseline CRP.||1.18|0.79|0.718
71682991|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
71869088|NCT04193436|143255275|OTHER||Ratio (%) of Adjusted Means|136.04|||||TWO_SIDED|90.0|104.75|176.67||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||176.67|104.75|
71869089|NCT04193436|143255275|OTHER||Ratio (%) of Adjusted Means|117.87|||||TWO_SIDED|90.0|89.61|155.03||||||The effect of the hepatic impairment on PK parameter Cmax,u were assessed by constructing 90% confidence intervals around the estimated difference between each of the Test (impaired) cohorts and the Reference (without hepatic impairment) cohort using a one-way ANOVA model based on natural log transformed data.||155.03|89.61|
71869090|NCT01156792|143255280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.026|||=|0.268|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||||0.07|-0.02|=0.268
71682992|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.092|<|0.0001|TWO_SIDED|95.0|-2.41|-2.05|||Mixed Model with Repeated Measures|||Gingival Sites, Week 4||-2.05|-2.41|<0.0001
71682993|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.5|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.69|-2.31|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.31|-2.69|<0.0001
71682994|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-2.81|-2.44|||Mixed Model with Repeated Measures|||Gingival Sites, Week 8||-2.44|-2.81|<0.0001
71682995|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.22|-1.91|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.91|-2.22|<0.0001
71682996|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001|TWO_SIDED|95.0|-2.2|-1.89|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 4||-1.89|-2.20|<0.0001
71869091|NCT01156792|143255280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|||=|0.08|TWO_SIDED|95.0|0.0|0.09|||Mixed Models Analysis|||||0.09|-0.00|=0.080
71869092|NCT01156792|143255280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.056|||=|0.017|TWO_SIDED|95.0|0.01|0.1|||Mixed Models Analysis|||||0.10|0.01|=0.017
71869093|NCT01156792|143255280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.074|||=|0.002|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||||0.12|0.03|=0.002
71913045|NCT04583969|143346199|SUPERIORITY||Odds Ratio (OR)|1.02||||0.907|TWO_SIDED|95.0|0.75|1.39|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Lenzilumab.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.39|0.75|0.907
71869094|NCT01156792|143255281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.946|||=|0.751|TWO_SIDED|95.0|-4.91|6.81|||Mixed Models Analysis|||||6.81|-4.91|=0.751
71869095|NCT01156792|143255281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.771|||=|0.049|TWO_SIDED|95.0|0.03|11.51|||Mixed Models Analysis|||||11.51|0.03|=0.049
71869096|NCT01156792|143255281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.983|||=|0.123|TWO_SIDED|95.0|-1.35|11.32|||Mixed Models Analysis|||||11.32|-1.35|=0.123
71869097|NCT01156792|143255281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.14|||<|0.001|TWO_SIDED|95.0|5.93|18.35|||Mixed Models Analysis|||||18.35|5.93|<0.001
71869098|NCT01156792|143255282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.651|||=|0.563|TWO_SIDED|95.0|-3.97|7.27|||Mixed Models Analysis|||||7.27|-3.97|=0.563
71869099|NCT01156792|143255282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|||=|0.072|TWO_SIDED|95.0|-0.47|10.67|||Mixed Models Analysis|||||10.67|-0.47|=0.072
71869100|NCT01156792|143255282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.822|||=|0.126|TWO_SIDED|95.0|-1.37|11.02|||Mixed Models Analysis|||||11.02|-1.37|=0.126
71869101|NCT01156792|143255282|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.292|||=|0.001|TWO_SIDED|95.0|4.21|16.38|||Mixed Models Analysis|||||16.38|4.21|=0.001
71869102|NCT01156792|143255283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.154|||||TWO_SIDED|95.0|-9.36|1.06||||||||1.06|-9.36|
71869103|NCT01156792|143255283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.364|||||TWO_SIDED|95.0|-6.22|5.5||||||||5.50|-6.22|
71869104|NCT01156792|143255284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|||=|0.957|TWO_SIDED|95.0|-0.18|0.17|||Mixed Models Analysis|||||0.17|-0.18|=0.957
71869105|NCT01156792|143255284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108|||=|0.213|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|||||0.06|-0.28|=0.213
71869106|NCT01156792|143255284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||=|0.647|TWO_SIDED|95.0|-0.2|0.12|||Mixed Models Analysis|||||0.12|-0.20|=0.647
71913046|NCT04583969|143346233|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.609|TWO_SIDED|95.0|0.87|1.27|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.27|0.87|0.609
71913047|NCT04583969|143346234|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.708|TWO_SIDED|95.0|0.85|1.26|||Regression, Cox||HR greater than 1 favors Remdesivir plus Lenzilumab|||1.26|0.85|0.708
71869107|NCT01156792|143255284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.011|||=|0.894|TWO_SIDED|95.0|-0.17|0.15|||Mixed Models Analysis|||||0.15|-0.17|=0.894
71869108|NCT01156792|143255285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||=|0.811|TWO_SIDED|95.0|-0.23|0.18|||Mixed Models Analysis|||||0.18|-0.23|=0.811
71869109|NCT01156792|143255285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.133|||=|0.2|TWO_SIDED|95.0|-0.34|0.07|||Mixed Models Analysis|||||0.07|-0.34|=0.200
71869110|NCT01156792|143255285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.076|||=|0.415|TWO_SIDED|95.0|-0.26|0.11|||Mixed Models Analysis|||||0.11|-0.26|=0.415
71869111|NCT01156792|143255285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||=|0.358|TWO_SIDED|95.0|-0.26|0.1|||Mixed Models Analysis|||||0.10|-0.26|=0.358
71869112|NCT01156792|143255286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.666|||=|0.285|TWO_SIDED|95.0|-2.24|7.57|||Mixed Models Analysis|||||7.57|-2.24|=0.285
71869113|NCT01156792|143255286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|||=|0.035|TWO_SIDED|95.0|0.38|10.22|||Mixed Models Analysis|||||10.22|0.38|=0.035
71869114|NCT01156792|143255286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.036|||=|0.09|TWO_SIDED|95.0|-0.63|8.7|||Mixed Models Analysis|||||8.70|-0.63|=0.090
71869115|NCT01156792|143255286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.602|||=|0.047|TWO_SIDED|95.0|0.06|9.14|||Mixed Models Analysis|||||9.14|0.06|=0.047
71869116|NCT01156792|143255287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
71869117|NCT01156792|143255287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
71869118|NCT01156792|143255287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
71869119|NCT01156792|143255287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
71869120|NCT01156792|143255288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.992|||=|0.367|TWO_SIDED|95.0|-2.35|6.33|||Mixed Models Analysis|||||6.33|-2.35|=0.367
71869121|NCT01156792|143255288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.147|||=|0.332|TWO_SIDED|95.0|-2.2|6.49|||Mixed Models Analysis|||||6.49|-2.20|=0.332
71869122|NCT01156792|143255288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.331|||=|0.277|TWO_SIDED|95.0|-1.88|6.55|||Mixed Models Analysis|||||6.55|-1.88|=0.277
71869123|NCT01156792|143255288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.521|||=|0.467|TWO_SIDED|95.0|-2.59|5.63|||Mixed Models Analysis|||||5.63|-2.59|=0.467
71869124|NCT01156792|143255289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.575|||=|0.789|TWO_SIDED|95.0|-3.65|4.8|||Mixed Models Analysis|||||4.80|-3.65|=0.789
71869125|NCT01156792|143255289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.669|||=|0.087|TWO_SIDED|95.0|-0.54|7.87|||Mixed Models Analysis|||||7.87|-0.54|=0.087
71869126|NCT01156792|143255289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||=|0.923|TWO_SIDED|95.0|-3.84|4.24|||Mixed Models Analysis|||||4.24|-3.84|=0.923
71869127|NCT01156792|143255289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.137|||=|0.571|TWO_SIDED|95.0|-5.08|2.81|||Mixed Models Analysis|||||2.81|-5.08|=0.571
71869128|NCT01156792|143255290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.014|||=|0.668|TWO_SIDED|95.0|-3.64|5.67|||Mixed Models Analysis|||||5.67|-3.64|=0.668
71869129|NCT01156792|143255290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.349|||=|0.156|TWO_SIDED|95.0|-1.29|7.98|||Mixed Models Analysis|||||7.98|-1.29|=0.156
71869130|NCT01156792|143255290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.496|||=|0.822|TWO_SIDED|95.0|-3.83|4.82|||Mixed Models Analysis|||||4.82|-3.83|=0.822
71869131|NCT01156792|143255290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|||=|0.555|TWO_SIDED|95.0|-2.94|5.46|||Mixed Models Analysis|||||5.46|-2.94|=0.555
71682997|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.29|STANDARD_ERROR_OF_MEAN|0.081|<|0.0001|TWO_SIDED|95.0|-2.45|-2.13|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.13|-2.45|<0.0001
71869132|NCT01156792|143255291|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
71869133|NCT01156792|143255291|SUPERIORITY_OR_OTHER||||||=|0.138||95.0|||||Fisher Exact|||||||=0.138
71869134|NCT01156792|143255291|SUPERIORITY_OR_OTHER||||||=|0.797||95.0|||||Fisher Exact|||||||=0.797
71869135|NCT01156792|143255291|SUPERIORITY_OR_OTHER||||||=|0.408||95.0|||||Fisher Exact|||||||=0.408
71869136|NCT00952120|143255333|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Regression, Logistic|robust standard errors were used to account for the multiple observations per patient||||||0.80
71913048|NCT01057862|143346237|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|6.0|STANDARD_DEVIATION|9.35|||TWO_SIDED||||||||The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
71682998|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-2.41|STANDARD_ERROR_OF_MEAN|0.082|<|0.0001|TWO_SIDED|95.0|-2.57|-2.25|||Mixed Model with Repeated Measures|||Interproximal Sites, Week 8||-2.25|-2.57|<0.0001
71869137|NCT03618823|143255340|EQUIVALENCE|All pain scores were included due to the sample size. Alpha =.05 Power = .80 Desired effect size of 0.30 Size of n=145 in each group was determined, however this was not reached for sufficient power.||||||0.912|||||||Mixed Models Analysis|Two-way mixed-model analysis of variance||There will be no difference in pain scores between opioid and non-opioid groups from before medication to after while controlling for total duration of mediation use (duration mean=10.11 days).||||.912
71869138|NCT03618823|143255341|SUPERIORITY||Odds Ratio (OR)|1.311||||0.63|TWO_SIDED|95.0|0.494|3.478|||Fisher Exact|||There will be no difference in ED (Emergency Department) or urgent care visits between opioid and non-opioid pain control groups.||3.478|.494|.630
71869139|NCT00523640|143255354|SUPERIORITY_OR_OTHER||Proportion responding|0.24|||||TWO_SIDED|95.0|0.1|0.44||||||||0.44|0.10|
71869140|NCT03535597|143255391|OTHER||Risk Ratio (RR)|0.99||||0.906|TWO_SIDED|95.0|0.89|1.11|||Chi-squared|||||1.11|0.89|0.906
71869141|NCT03535597|143255391|OTHER||Risk Ratio (RR)|1.27||||0.002|TWO_SIDED|95.0|1.09|1.53|||Chi-squared|||||1.53|1.09|0.002
71869142|NCT03535597|143255391|OTHER||Risk Ratio (RR)|0.97||||0.613|TWO_SIDED|95.0|0.86|1.09|||Chi-squared|||||1.09|0.86|0.613
71869143|NCT03535597|143255392|OTHER||Mean Difference (Net)|-98.5|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71869144|NCT03535597|143255392|OTHER||Mean Difference (Net)|-120.6|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
71869145|NCT03535597|143255392|OTHER||Mean Difference (Net)|-94.3|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||< 0.001
71869146|NCT03535597|143255393|OTHER||Risk Ratio (RR)|0.77||||0.744|TWO_SIDED|95.0|0.23|2.57|||Fisher Exact|||||2.57|0.23|0.744
71869147|NCT03535597|143255393|OTHER||Risk Ratio (RR)|1.02|||>|0.999|TWO_SIDED|95.0|0.31|3.41|||Fisher Exact|||||3.41|0.31|>0.999
71869148|NCT03535597|143255393|OTHER||Risk Ratio (RR)|0.67||||0.724|TWO_SIDED|95.0|0.18|2.46|||Fisher Exact|||||2.46|0.18|0.724
71869149|NCT03535597|143255394|OTHER||Risk Ratio (RR)|1.44||||0.594|TWO_SIDED|95.0|0.56|3.76|||Fisher Exact|||||3.76|0.56|0.594
71869150|NCT03535597|143255394|OTHER||Risk Ratio (RR)|1.1|||>|0.999|TWO_SIDED|95.0|0.37|3.26|||Fisher Exact|||||3.26|0.37|>0.999
71869151|NCT03535597|143255394|OTHER||Risk Ratio (RR)|1.45||||0.581|TWO_SIDED|95.0|0.55|3.88|||Fisher Exact|||||3.88|0.55|0.581
71869152|NCT03535597|143255395|OTHER||Risk Ratio (RR)|1.92||||0.284|TWO_SIDED|95.0|0.71|5.22|||Fisher Exact|||||5.22|0.71|0.284
71869153|NCT03535597|143255395|OTHER||Risk Ratio (RR)|2.1||||0.243|TWO_SIDED|95.0|0.75|5.9|||Fisher Exact|||||5.9|0.75|0.243
71869154|NCT03535597|143255395|OTHER||Risk Ratio (RR)|2.01||||0.266|TWO_SIDED|95.0|0.74|5.54|||Fisher Exact|||||5.54|0.74|0.266
71869155|NCT02632526|143255426|SUPERIORITY_OR_OTHER||Slope|1.24|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|1.17|1.31||||||||1.31|1.17|
71682999|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.76|-0.5|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.50|-0.76|<0.0001
71869156|NCT02632526|143255426|SUPERIORITY_OR_OTHER||Slope|0.322|STANDARD_ERROR_OF_MEAN|0.182|||TWO_SIDED|90.0|-0.0124|0.656||||||||0.656|-0.0124|
71869157|NCT02632526|143255427|SUPERIORITY_OR_OTHER||Slope|1.22|STANDARD_ERROR_OF_MEAN|0.0813|||TWO_SIDED|90.0|1.08|1.36||||||Day 1||1.36|1.08|
71869158|NCT02632526|143255429|SUPERIORITY_OR_OTHER||Slope|1.23|STANDARD_ERROR_OF_MEAN|0.0851|||TWO_SIDED|90.0|1.08|1.38||||||Day 10||1.38|1.08|
71869159|NCT02632526|143255430|SUPERIORITY_OR_OTHER||Slope|1.55|STANDARD_ERROR_OF_MEAN|0.0692|||TWO_SIDED|90.0|1.43|1.66||||||||1.66|1.43|
71869160|NCT02632526|143255430|SUPERIORITY_OR_OTHER||Slope|0.35|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|0.0315|0.669||||||||0.669|0.0315|
71869161|NCT02632526|143255431|SUPERIORITY_OR_OTHER||Slope|1.48|STANDARD_ERROR_OF_MEAN|0.0839|||TWO_SIDED|90.0|1.34|1.63||||||For Day 1||1.63|1.34|
71869162|NCT02632526|143255431|SUPERIORITY_OR_OTHER||Slope|1.43|STANDARD_ERROR_OF_MEAN|0.104|||TWO_SIDED|90.0|1.25|1.6||||||Day 10||1.60|1.25|
71869163|NCT02632526|143255444|SUPERIORITY_OR_OTHER||Ratio|28.13|||||TWO_SIDED|90.0|20.98|37.73||||||Cmax||37.73|20.98|
71869164|NCT02632526|143255445|SUPERIORITY_OR_OTHER||Ratio|64.58|||||TWO_SIDED|90.0|54.34|76.74||||||AUC(0-τ)||76.74|54.34|
71869165|NCT03954392|143255458|OTHER||||||<|0.05|||||||ANCOVA|Only one statistical test was conducted, therefore no adjustments for multiple comparisons was needed.||Statistical analysis will compare the post-intervention scores on the primary outcome (Faux Pas Recognition Test scores), controlling for pre-intervention scores.||||< 0.05
71869166|NCT03954392|143255459|OTHER||||||<|0.05|||||||ANCOVA|||||||< 0.05
71869167|NCT01226095|143255644|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||||||<0.0001
71869168|NCT00857272|143255653|NON_INFERIORITY_OR_EQUIVALENCE|Fifteen percent has been established as an acceptable non-inferiority margin for evaluation of investigational bowel preparations in previous studies of FDA approved preparations (e.g. NuLytely, MoviPrep).|Difference in success rates|-2.5||||0.005|TWO_SIDED|95.0|-11.9|6.8|||Chi-squared|||"The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2\<=D0 versus Alternative Hypothesis H1: P1-P2=D1\>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%."||6.8|-11.9|0.005
71683000|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.77|-0.51|||Mixed Model with Repeated Measures|||Body Sites, Week 4||-0.51|-0.77|<0.0001
71683001|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
71869169|NCT01285609|143255664|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.907||||0.2517|TWO_SIDED|95.0|0.767|1.072|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.072|0.767|0.2517
71869170|NCT01285609|143255665|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.917||||0.2421|TWO_SIDED|95.0|0.792|1.061||p-value based on stratified 2-sided log-rank test|Log Rank||Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.061|0.792|0.2421
71869171|NCT01285609|143255666|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.869||||0.0678|TWO_SIDED|95.0|0.749|1.009|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin||1.009|0.749|0.0678
71869172|NCT03283072|143255681|SUPERIORITY|||||||0.592|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.592
71869173|NCT03283072|143255682|SUPERIORITY|||||||0.721|||||||ANCOVA|Within, within repeated measures ANCOVA (gender as co-variate).||||||0.721
71869174|NCT03283072|143255683|SUPERIORITY|||||||0.553|||||||ANCOVA|Within, within repeated measures ANVOA (gender as covariate)||||||0.553
71869175|NCT02552368|143255700|SUPERIORITY|||||||0.002|||||||Paired t-Test|||||||0.002
71869176|NCT02552368|143255701|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Performance COPM between Baseline and 12 weeks||||0.022
71869177|NCT02552368|143255701|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks||||0.031
71869178|NCT00715962|143255720|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|Fisher's exact test used as the rate of falling was low.||||||<.05
71869179|NCT00715962|143255721|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
71869180|NCT03241225|143255749|SUPERIORITY||Mean Difference (Final Values)|3.59||||0.16|TWO_SIDED|95.0|-1.43|8.61|||t-test, 2 sided||Mean change in EM/PROTECT group not significantly different from mean change in EM/MH group, at week 12.|Week 12||8.61|-1.43|0.16
71869181|NCT03241225|143255750|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.79|TWO_SIDED|95.0|-1.37|1.05|||t-test, 2 sided|||Domain #1, Week 12||1.05|-1.37|0.79
71869182|NCT03241225|143255750|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.19|TWO_SIDED|95.0|-0.7|3.46|||t-test, 2 sided|||Domain #2, Week 12||3.46|-0.70|0.19
71869183|NCT03241225|143255750|SUPERIORITY||Mean Difference (Final Values)|-4.53||||0.37|TWO_SIDED|95.0|-14.99|5.93|||t-test, 2 sided|||Domain #3, Week 12||5.93|-14.99|0.37
71683002|NCT05459558|142884017|SUPERIORITY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.81|-0.57|||Mixed Model with Repeated Measures|||Body Sites, Week 8||-0.57|-0.81|<0.0001
71683003|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.97|-0.82|||Mixed Model with Repeated Measures|||Area, Week 4||-0.82|-0.97|<0.0001
71869184|NCT03241225|143255750|SUPERIORITY||Mean Difference (Final Values)|-5.24||||0.026|TWO_SIDED|95.0|-9.75|-0.73|||t-test, 2 sided|||Domain #4, Week 12||-0.73|-9.75|0.026
71869185|NCT03241225|143255750|SUPERIORITY||Mean Difference (Final Values)|-0.62||||0.66|TWO_SIDED|95.0|-3.51|2.27|||t-test, 2 sided|||Domain #5, Week 12||2.27|-3.51|0.66
71869186|NCT03241225|143255751|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.14|TWO_SIDED|95.0|-0.26|1.66|||t-test, 2 sided|||Domain #1, Week 12||1.66|-0.26|0.14
71869187|NCT03241225|143255751|SUPERIORITY||Mean Difference (Final Values)|0.78||||0.047|TWO_SIDED|95.0|0.011|1.55||Domain #2|t-test, 2 sided|||Domain #2, Week 12||1.55|0.011|0.047
71869188|NCT03241225|143255751|SUPERIORITY||Mean Difference (Final Values)|0.65||||0.18|TWO_SIDED|95.0|-0.34|1.64|||t-test, 2 sided|||Domain #3, Week 12||1.64|-0.34|0.18
71869189|NCT02074553|143255773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|100.5|||||TWO_SIDED|90.0|93.14|108.44|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% confidence interval (CI).||108.44|93.14|
71869190|NCT02074553|143255773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.82|||||TWO_SIDED|90.0|90.71|105.48|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.48|90.71|
71869191|NCT02074553|143255773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.66|||||TWO_SIDED|90.0|80.32|93.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.5|80.32|
71869192|NCT02074553|143255773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.62|||||TWO_SIDED|90.0|85.15|92.24|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.24|85.15|
71869193|NCT02074553|143255773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.17|||||TWO_SIDED|90.0|77.08|83.39|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.39|77.08|
71869194|NCT02074553|143255773|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|79.95|||||TWO_SIDED|90.0|76.84|83.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||83.19|76.84|
71869195|NCT02074553|143255774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|99.12|||||TWO_SIDED|90.0|91.83|106.99|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.99|91.83|
71683004|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|-0.95|-0.79|||Mixed Model with Repeated Measures|||Area, Week 4||-0.79|-0.95|<0.0001
71683005|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.15|-1.01|||Mixed Model with Repeated Measures|||Area, Week 8||-1.01|-1.15|<0.0001
71683006|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001|TWO_SIDED|95.0|-1.22|-1.07|||Mixed Model with Repeated Measures|||Area, Week 8||-1.07|-1.22|<0.0001
71869196|NCT02074553|143255774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.79|||||TWO_SIDED|90.0|86.94|101.17|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.17|86.94|
71869197|NCT02074553|143255774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.32|||||TWO_SIDED|90.0|74.41|86.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.7|74.41|
71869198|NCT02074553|143255774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.42|||||TWO_SIDED|90.0|83.92|91.07|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.07|83.92|
71869199|NCT02074553|143255774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.87|||||TWO_SIDED|90.0|75.76|82.11|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.11|75.76|
71869200|NCT02074553|143255774|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.66|||||TWO_SIDED|90.0|75.53|81.92|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.92|75.53|
71869201|NCT02074553|143255775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.34|||||TWO_SIDED|90.0|82.33|99.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.12|82.33|
71869202|NCT02074553|143255775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.28|||||TWO_SIDED|90.0|60.45|72.68|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.68|60.45|
71913049|NCT01057862|143346238|OTHER|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|14.2|STANDARD_DEVIATION|9.45|||TWO_SIDED||||||||The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.||||
71869203|NCT02074553|143255775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|41.04|||||TWO_SIDED|90.0|37.4|45.03|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||45.03|37.40|
71869204|NCT02074553|143255775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.3|||||TWO_SIDED|90.0|81.77|91.09|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.09|81.77|
71869205|NCT02074553|143255775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.0|||||TWO_SIDED|90.0|73.01|81.2|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||81.20|73.01|
71869206|NCT02074553|143255775|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.65|||||TWO_SIDED|90.0|71.71|79.82|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.82|71.71|
71913050|NCT03434041|143346318|SUPERIORITY||Difference of Least Square (LS) Means|-2.0||||0.123|TWO_SIDED|95.0|-4.64|0.55||2-sided|Mixed-effects Model for Repeated Measure|||||0.55|-4.64|0.123
71913051|NCT03434041|143346319|SUPERIORITY||Difference of LS Means|-3.3|||||TWO_SIDED|95.0|-5.33|-1.33||||||||-1.33|-5.33|
71913052|NCT03434041|143346320|SUPERIORITY||Difference of LS Means|-1.0|||||TWO_SIDED|95.0|-2.96|0.97||||||||0.97|-2.96|
71913053|NCT00444080|143346332|OTHER|||||||0.013|||||||Fisher Exact|||||||0.013
71683007|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
71869207|NCT02074553|143255777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.67|||||TWO_SIDED|90.0|82.34|102.05|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.05|82.34|
71869208|NCT02074553|143255777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.24|||||TWO_SIDED|90.0|60.44|74.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.79|60.44|
71869209|NCT02074553|143255777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|34.32|||||TWO_SIDED|90.0|30.83|38.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||38.21|30.83|
71869210|NCT02074553|143255777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.15|||||TWO_SIDED|90.0|89.1|101.62|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||101.62|89.10|
71869211|NCT02074553|143255777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|68.67|78.16|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.16|68.67|
71869212|NCT02074553|143255777|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.76|||||TWO_SIDED|90.0|63.48|72.33|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.33|63.48|
71869213|NCT02074553|143255779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.77|||||TWO_SIDED|90.0|87.54|104.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||104.79|87.54|
71869214|NCT02074553|143255779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.69|||||TWO_SIDED|90.0|71.97|86.04|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||86.04|71.97|
71869215|NCT02074553|143255779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|53.91|||||TWO_SIDED|90.0|49.27|58.98|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||58.98|49.27|
71869216|NCT02074553|143255779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.16|||||TWO_SIDED|90.0|86.14|94.37|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.37|86.14|
71869217|NCT02074553|143255779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.76|||||TWO_SIDED|90.0|70.52|77.15|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.15|70.52|
71869218|NCT02074553|143255779|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|70.94|||||TWO_SIDED|90.0|67.8|74.22|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||74.22|67.80|
71683008|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|-0.93|-0.8|||Mixed Model with Repeated Measures|||Intensity, Week 4||-0.80|-0.93|<0.0001
71913054|NCT03363165|143346339|SUPERIORITY||Mean Difference (Final Values)|-13.54||||0.7586|ONE_SIDED|90.0|-38.52||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-38.52|0.7586
71683009|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.04|-0.9|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.90|-1.04|<0.0001
71913055|NCT03363165|143346340|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.0298|ONE_SIDED|90.0|0.78||||ANCOVA|Adjusted for baseline maximal treadmill walking time, age, race, former smoker|||||0.78|0.0298
71913056|NCT03363165|143346341|SUPERIORITY||Mean Difference (Final Values)|0.69||||0.4019|ONE_SIDED|90.0|-3.1||||ANCOVA|Adjusted for baseline perfusion, age, race, former smoker.|||||-3.10|0.4019
71913057|NCT03363165|143346342|SUPERIORITY||Mean Difference (Final Values)|8.28||||0.208|ONE_SIDED|90.0|-5.37||||ANCOVA|Adjusted for baseline muscle measure, age, race, former smoker.|||||-5.37|0.2080
71913058|NCT03363165|143346343|SUPERIORITY||Mean Difference (Final Values)|2.02||||0.398|ONE_SIDED|90.0|-8.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker|||||-8.11|0.3980
71913059|NCT03363165|143346344|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.7852|ONE_SIDED|90.0|-14.5||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-14.50|0.7852
71913060|NCT03363165|143346345|SUPERIORITY||Mean Difference (Final Values)|-5.14||||0.8414|ONE_SIDED|90.0|-11.76||||ANCOVA|Adjusted for baseline SF-36 physical functioning score, age, race, former smoker.|||||-11.76|0.8414
71913061|NCT03363165|143346346|SUPERIORITY||Mean Difference (Final Values)|-2.13||||0.5912|ONE_SIDED|90.0|-14.11||||ANCOVA|Adjusted for baseline WIQ distance score, age, race, former smoker.|||||-14.11|0.5912
71913062|NCT03363165|143346347|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.5442|ONE_SIDED|90.0|-25.47||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-25.47|0.5442
71913063|NCT03363165|143346348|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6603|ONE_SIDED|90.0|-2.11|||Adjusted for baseline pain-free treadmill walking time, age, race, former smoker.|ANCOVA||||||-2.11|0.6603
71913064|NCT03363165|143346349|SUPERIORITY||Mean Difference (Final Values)|-2.78||||0.5647|ONE_SIDED|90.0|-24.99||||ANCOVA|Adjusted for baseline six-minute walk distance, age, race, former smoker.|||||-24.99|0.5647
71913065|NCT02052141|143346374|SUPERIORITY||Mean difference|-0.4|STANDARD_DEVIATION|0.58||0.03|TWO_SIDED|90.0|-0.71|-0.1|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.10|-0.71|0.03
71683010|NCT05459558|142884018|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|-1.08|-0.95|||Mixed Model with Repeated Measures|||Intensity, Week 8||-0.95|-1.08|<0.0001
71913066|NCT02052141|143346375|SUPERIORITY||Mean difference|-0.7|STANDARD_DEVIATION|1.06||0.05|TWO_SIDED|90.0|-1.2|-0.11|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.11|-1.20|0.05
71913067|NCT02052141|143346376|SUPERIORITY||Mean difference|-1.9|STANDARD_DEVIATION|2.82||0.04|TWO_SIDED|90.0|-3.31|-0.38|||Paired t-test||The difference between treatment B over treatment A was estimated.|||-0.38|-3.31|0.04
71913068|NCT02052141|143346377|SUPERIORITY||Mean difference|-0.2|STANDARD_DEVIATION|0.37||0.07|TWO_SIDED|90.0|-0.41|-0.03|||Paired t-test||The difference between treatment B over treatment A was estimated|||-0.03|-0.41|0.07
71913069|NCT02420990|143346383|SUPERIORITY||Slope|-0.31|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71913070|NCT02420990|143346383|SUPERIORITY||Slope|-0.67|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71913071|NCT02420990|143346383|SUPERIORITY||Slope|0.05||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
71913072|NCT02420990|143346383|SUPERIORITY||Slope|0.56||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
71913073|NCT02420990|143346383|SUPERIORITY||Slope|-0.72||||0.05|TWO_SIDED||||||Latent Growth Curve Modeling|||||||0.05
71913074|NCT02420990|143346384|SUPERIORITY||Slope|-1.78|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
71913075|NCT02420990|143346384|SUPERIORITY||Slope|-0.64|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71913076|NCT02420990|143346384|SUPERIORITY||Slope|0.07|||||TWO_SIDED||||||Linear Growth Curve Modeling|||||||
71913077|NCT02420990|143346384|SUPERIORITY||Slope|0.0|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71913078|NCT02420990|143346384|SUPERIORITY||Slope|-1.44|||||TWO_SIDED||||||Latent Growth Curve Modeling|||||||
71913079|NCT02420990|143346385|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.56|TWO_SIDED||||||Regression, Linear|||||||.56
71913080|NCT01484561|143346386|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.92|||||TWO_SIDED|90.0|0.86|0.98|||ANCOVA||Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.86|
71913081|NCT01484561|143346387|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|0.97|1.11|||ANCOVA||ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.11|0.97|
71913082|NCT01484561|143346388|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.09|||||TWO_SIDED|90.0|1.02|1.16|||ANCOVA||ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.16|1.02|
71913083|NCT01484561|143346389|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.94|||||TWO_SIDED|90.0|0.91|0.97|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.97|0.91|
71913084|NCT01484561|143346390|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.96|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.96|
71913085|NCT01484561|143346391|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.0|1.08|||ANCOVA||ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.00|
71913086|NCT01484561|143346392|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.95|||||TWO_SIDED|90.0|0.92|0.98|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||0.98|0.92|
71913087|NCT01484561|143346393|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||TWO_SIDED|90.0|0.97|1.02|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.02|0.97|
71913088|NCT01484561|143346394|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||TWO_SIDED|90.0|1.01|1.07|||ANCOVA||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.07|1.01|
71913089|NCT01484561|143346395|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.05|||||TWO_SIDED|90.0|1.02|1.08|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.08|1.02|
71913090|NCT01484561|143346396|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|1.01|||||TWO_SIDED|90.0|0.98|1.04|||ANCOVA||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.04|0.98|
71913091|NCT01484561|143346397|SUPERIORITY_OR_OTHER||Ratio of Adjusted Geo Mean-Fold Change|0.97|||||TWO_SIDED|90.0|0.94|1.0|||ANCOVA||ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)||1.00|0.94|
71913092|NCT01484561|143346398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|36.16|STANDARD_ERROR_OF_MEAN|7.64|<|0.001|TWO_SIDED|90.0|23.6|48.73||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 1||48.73|23.60|<0.001
71913093|NCT01484561|143346398|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.95|STANDARD_ERROR_OF_MEAN|8.14||0.05|TWO_SIDED|90.0|2.56|29.34||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 2||29.34|2.56|0.050
71913094|NCT01484561|143346399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.02|STANDARD_ERROR_OF_MEAN|5.94|<|0.001|TWO_SIDED|90.0|11.24|30.8||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 1||30.80|11.24|<0.001
71913095|NCT01484561|143346399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.0|STANDARD_ERROR_OF_MEAN|6.13||0.006|TWO_SIDED|90.0|6.92|27.08||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 2||27.08|6.92|0.006
71913096|NCT01484561|143346400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.56|STANDARD_ERROR_OF_MEAN|3.95|<|0.001|TWO_SIDED|90.0|12.06|25.05||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 1||25.05|12.06|<0.001
71913097|NCT01484561|143346400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.32|STANDARD_ERROR_OF_MEAN|3.53||0.038|TWO_SIDED|90.0|1.51|13.12||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 2||13.12|1.51|0.038
71913098|NCT01484561|143346401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|90.0|-1.53|-0.78||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.78|-1.53|<0.001
71913099|NCT01484561|143346402|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.21||0.028|TWO_SIDED|90.0|-0.83|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.83|0.028
71913100|NCT01484561|143346403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|0.22||0.002|TWO_SIDED|90.0|0.32|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|0.32|0.002
71913101|NCT01484561|143346404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|90.0|-1.67|-0.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.84|-1.67|<0.001
71913102|NCT01484561|143346405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.031|TWO_SIDED|90.0|-0.88|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.12|-0.88|0.031
71913103|NCT01484561|143346406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|90.0|0.36|1.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.15|0.36|0.002
71683011|NCT03292458|142884027|SUPERIORITY|The primary efficacy outcome was analyzed using a restricted maximum likelihood (REML)-based linear mixed-effect model. The analysis included group, treatment, and treatment period as interacting fixed effects and subject as random effect. An unstructured covariance structure was used to model the within-patient errors.||||||0.01|TWO_SIDED|98.75|||||Mixed Models Analysis|||||||0.01
71869219|NCT02074553|143255780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.05|||||TWO_SIDED|90.0|84.24|102.78|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||102.78|84.24|
71683012|NCT03292458|142884028|OTHER|The minimum and average efficacy (in % symptom change) of sodium oxybate versus placebo in improving symptoms compared to the baseline was determined using binomial logistic regression.||||||0.05|TWO_SIDED|98.75|||||Regression, Logistic|||The minimum and average efficacy of sodium oxybate vs. placebo in improving symptoms compared to the baseline were determined using binomial logistic regression.||||0.05
71869220|NCT02074553|143255780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|74.35|||||TWO_SIDED|90.0|67.37|82.06|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||82.06|67.37|
71869221|NCT02074553|143255780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|43.94|||||TWO_SIDED|90.0|39.78|48.53|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||48.53|39.78|
71869222|NCT02074553|143255780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.21|||||TWO_SIDED|90.0|86.12|94.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.49|86.12|
71869223|NCT02074553|143255780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|72.72|||||TWO_SIDED|90.0|69.48|76.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||76.12|69.48|
71869224|NCT02074553|143255780|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|69.34|||||TWO_SIDED|90.0|66.23|72.61|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||72.61|66.23|
71869225|NCT02074553|143255783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|98.79|||||TWO_SIDED|90.0|91.25|106.95|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||106.95|91.25|
71869226|NCT02074553|143255783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.58|||||TWO_SIDED|90.0|84.65|99.08|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||99.08|84.65|
71869227|NCT02074553|143255783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.41|||||TWO_SIDED|90.0|67.81|79.47|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.47|67.81|
71869228|NCT02074553|143255783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.81|||||TWO_SIDED|90.0|85.62|92.13|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||92.13|85.62|
71869229|NCT02074553|143255783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.74|||||TWO_SIDED|90.0|74.99|80.6|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||80.60|74.99|
71683013|NCT03292458|142884029|OTHER||Mean Difference (Final Values)|98.75||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71683014|NCT03292458|142884030|OTHER|||||||0.01|TWO_SIDED|98.75|||||ANOVA|||||||0.01
71913104|NCT01484561|143346407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.09|STANDARD_ERROR_OF_MEAN|2.02||0.045|TWO_SIDED|90.0|-7.44|-0.74||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.74|-7.44|0.045
71913105|NCT01484561|143346408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|1.76||0.936|TWO_SIDED|90.0|-2.78|3.06||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.06|-2.78|0.936
71913106|NCT01484561|143346409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.23|STANDARD_ERROR_OF_MEAN|1.93||0.03|TWO_SIDED|90.0|1.04|7.42||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||7.42|1.04|0.030
71913107|NCT01484561|143346410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|1.03||0.03|TWO_SIDED|90.0|-3.96|-0.55||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.55|-3.96|0.030
71913108|NCT01484561|143346411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|1.11||0.472|TWO_SIDED|90.0|-2.64|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||1.04|-2.64|0.472
71913109|NCT01484561|143346412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|1.03||0.158|TWO_SIDED|90.0|-0.24|3.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||3.15|-0.24|0.158
71913110|NCT01484561|143346413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.73|STANDARD_ERROR_OF_MEAN|3.71|<|0.001|TWO_SIDED|90.0|-19.87|-7.59||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.59|-19.87|<0.001
71913111|NCT01484561|143346414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.89|STANDARD_ERROR_OF_MEAN|4.04||0.029|TWO_SIDED|90.0|-15.58|-2.21||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-2.21|-15.58|0.029
71913112|NCT01484561|143346415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.84|STANDARD_ERROR_OF_MEAN|2.98||0.107|TWO_SIDED|90.0|-0.1|9.77||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||9.77|-0.10|0.107
71913113|NCT01484561|143346416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|4.87||0.001|TWO_SIDED|90.0|-23.96|-7.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.84|-23.96|0.001
71913114|NCT01484561|143346417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|4.95||0.251|TWO_SIDED|90.0|-13.9|2.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.50|-13.90|0.251
71913115|NCT01484561|143346418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.19|STANDARD_ERROR_OF_MEAN|4.42||0.023|TWO_SIDED|90.0|2.87|17.52||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.52|2.87|0.023
71913116|NCT01484561|143346419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.12|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|90.0|-21.58|-8.67||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-8.67|-21.58|<0.001
71913117|NCT01484561|143346420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|4.77||0.616|TWO_SIDED|90.0|-10.3|5.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||5.50|-10.30|0.616
71683015|NCT03292458|142884031|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
71683016|NCT03292458|142884032|OTHER|||||||0.01|TWO_SIDED|98.75|||||Pearson correlation|||||||0.01
71683017|NCT04643964|142884133|SUPERIORITY|||||||0.54|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. No covariates were included.||||.54
71869230|NCT02074553|143255783|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.65|||||TWO_SIDED|90.0|73.92|79.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.49|73.92|
71869231|NCT02074553|143255784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|89.41|||||TWO_SIDED|90.0|81.7|97.84|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||97.84|81.7|
71869232|NCT02074553|143255784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.84|||||TWO_SIDED|90.0|61.12|73.1|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.1|61.12|
71869233|NCT02074553|143255784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|42.32|||||TWO_SIDED|90.0|38.68|46.32|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||46.32|38.68|
71869234|NCT02074553|143255784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.76|||||TWO_SIDED|90.0|84.21|93.56|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||93.56|84.21|
71869235|NCT02074553|143255784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.82|||||TWO_SIDED|90.0|71.99|79.86|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.86|71.99|
71869236|NCT02074553|143255784|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||TWO_SIDED|90.0|69.53|77.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||77.19|69.53|
71869237|NCT02074553|143255785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.23|||||TWO_SIDED|90.0|89.85|105.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||105.21|89.85|
71869238|NCT02074553|143255785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.16|||||TWO_SIDED|90.0|80.59|94.26|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||94.26|80.59|
71869239|NCT02074553|143255785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.86|||||TWO_SIDED|90.0|62.71|73.43|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||73.43|62.71|
71869240|NCT02074553|143255785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.28|||||TWO_SIDED|90.0|85.06|91.63|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||91.63|85.06|
71869241|NCT02074553|143255785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.79|||||TWO_SIDED|90.0|74.03|79.65|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||79.65|74.03|
71913118|NCT01484561|143346421|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.72|STANDARD_ERROR_OF_MEAN|4.17||0.003|TWO_SIDED|90.0|5.82|19.62||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||19.62|5.82|0.003
71683018|NCT04643964|142884134|SUPERIORITY|||||||0.92|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.92
71869242|NCT02074553|143255785|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.43|||||TWO_SIDED|90.0|72.7|78.27|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.||78.27|72.70|
71869243|NCT04187989|143255826|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.006|STANDARD_ERROR_OF_MEAN|0.239||0.98|TWO_SIDED|95.0|-0.478|0.466|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.466|-.478|.980
71869244|NCT04187989|143255827|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.265|STANDARD_ERROR_OF_MEAN|0.18||0.14|TWO_SIDED|95.0|-0.092|0.621||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.621|-.092|.140
71869245|NCT04187989|143255829|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.064|STANDARD_ERROR_OF_MEAN|0.181||0.724|TWO_SIDED|95.0|-0.294|0.421||Two-sided test of the null hypothesis of no difference between groups|t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.421|-.294|.724
71869246|NCT04187989|143255830|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.078|STANDARD_ERROR_OF_MEAN|0.175||0.656|TWO_SIDED|95.0|-0.425|0.269|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.269|-.425|.656
71869247|NCT04187989|143255831|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.339|STANDARD_ERROR_OF_MEAN|0.205||0.158|TWO_SIDED|95.0|-0.746|0.067||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|||0.067|-.746|.158
71869248|NCT04187989|143255832|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.143|STANDARD_ERROR_OF_MEAN|0.178||0.422|TWO_SIDED|95.0|-0.21|0.495|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.495|-.210|.422
71913119|NCT01484561|143346422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|4.52|<|0.001|TWO_SIDED|90.0|-22.78|-7.82||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-7.82|-22.78|<0.001
71913120|NCT01484561|143346423|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.62|STANDARD_ERROR_OF_MEAN|4.83||0.247|TWO_SIDED|90.0|-13.62|2.38||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||2.38|-13.62|0.247
71869249|NCT04187989|143255833|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.027|STANDARD_ERROR_OF_MEAN|0.179||0.882|TWO_SIDED|95.0|-0.328|0.381|||t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.381|-.328|.882
71869250|NCT04187989|143255834|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.197|STANDARD_ERROR_OF_MEAN|0.268||0.497|TWO_SIDED|95.0|-0.728|0.334||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.334|-.728|.497
71869251|NCT04187989|143255835|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.042|STANDARD_ERROR_OF_MEAN|0.18||0.813|TWO_SIDED|95.0|-0.398|0.313||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.313|-.398|.813
71869252|NCT04187989|143255836|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.034|STANDARD_ERROR_OF_MEAN|0.176||0.849|TWO_SIDED|95.0|-0.381|0.314||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.314|-.381|.849
71869253|NCT04187989|143255837|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.118|STANDARD_ERROR_OF_MEAN|0.247||0.667|TWO_SIDED|95.0|-0.607|0.371||The p-value is for the coefficient of the treatment/control indicator in the above mixed model|t-test, 2 sided||The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.371|-.607|.667
71869254|NCT04187989|143255838|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.342|STANDARD_ERROR_OF_MEAN|0.175||0.051|TWO_SIDED|95.0|-0.689|0.005|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs||.005|-.689|.051
71913121|NCT01484561|143346424|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.68|STANDARD_ERROR_OF_MEAN|4.67||0.04|TWO_SIDED|90.0|1.95|17.41||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||17.41|1.95|0.040
71913122|NCT01484561|143346425|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|90.0|-0.56|-0.23||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.23|-0.56|<0.001
71683019|NCT04643964|142884135|SUPERIORITY|||||||0.37|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There were three covariates in this model: QIDS at Time 1, gender, and COVID interference.||||.37
71913123|NCT01484561|143346426|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.09||0.053|TWO_SIDED|90.0|-0.31|-0.03||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||-0.03|-0.31|0.053
71913124|NCT01484561|143346427|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|90.0|0.1|0.35||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect|||0.35|0.10|0.003
71913125|NCT03371251|143346429|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: SRI-4 Response||18.5|-14.5|0.8434
71913126|NCT03371251|143346429|SUPERIORITY||Observed Difference vs. Placebo|2.0||||0.8434|TWO_SIDED|90.0|-14.5|18.5|||Pearson's chi-square test|||Statistical Analysis: \>= 4-Point Reduction from Baseline in SLEDAI-2K Global Score||18.5|-14.5|0.8434
71913127|NCT03371251|143346429|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No New BILAG A or More than One BILAG B Organ Score Compared with Baseline||30.9|4.5|0.0141
71913128|NCT03371251|143346429|SUPERIORITY||Observed Difference vs. Placebo|17.7||||0.0141|TWO_SIDED|90.0|4.5|30.9|||Pearson's chi-square test|||Statistical Analysis: No Deterioration from Baseline in PGA by \>=30mm||30.9|4.5|0.0141
71913129|NCT03371251|143346445|SUPERIORITY||Observed Difference vs. Placebo|-2.6||||0.7985|TWO_SIDED|90.0|-19.8|14.5|||Pearson's chi-square test|||||14.5|-19.8|0.7985
71913130|NCT03371251|143346446|SUPERIORITY||Observed Difference vs. Placebo|-6.9||||0.3498|TWO_SIDED|90.0|-22.9|9.8|||Pearson's chi-square test|||Statistical Analysis for Overall||9.8|-22.9|0.3498
71913131|NCT03371251|143346447|SUPERIORITY||Observed Difference vs. Placebo|-21.8||||0.0072|TWO_SIDED|90.0|-36.2|-7.4|||Pearson's chi-square test|||Statistical analysis for Overall||-7.4|-36.2|0.0072
71913132|NCT03371251|143346447|SUPERIORITY||Observed Difference vs. Placebo|-17.7||||0.0141|TWO_SIDED|90.0|-30.9|-4.5|||Pearson's chi-square test|||Statistical Analysis for Day 210||-4.5|-30.9|0.0141
71913133|NCT03371251|143346448|SUPERIORITY||Observed Difference vs. Placebo|4.9||||0.6107|TWO_SIDED|90.0|-10.7|20.5|||Pearson's chi-square test|||||20.5|-10.7|0.6107
71913134|NCT03371251|143346449|SUPERIORITY||Observed Difference vs. Placebo|15.4||||0.1237|TWO_SIDED|90.0|-0.9|31.8|||Pearson's chi-square test|||||31.8|-0.9|0.1237
71913135|NCT03371251|143346450|SUPERIORITY||Observed Difference vs. Placebo|-13.7||||0.0581|TWO_SIDED|90.0|-26.7|-0.7|||Pearson's chi-square test|||Statistical Analysis for Overall||-0.7|-26.7|0.0581
71913136|NCT03371251|143346450|SUPERIORITY||Observed Difference vs. Placebo|-14.3||||0.0471|TWO_SIDED|90.0|-31.2|3.2|||Pearson's chi-square test|||Statistical Analysis for Day 210||3.2|-31.2|0.0471
71913137|NCT03371251|143346451|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|-0.3|STANDARD_ERROR_OF_MEAN|0.78||0.6596|TWO_SIDED|90.0|-1.63|0.94|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-A (Total Activity)||0.94|-1.63|0.6596
71913138|NCT03371251|143346451|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.3|STANDARD_ERROR_OF_MEAN|0.33||0.4105|TWO_SIDED|90.0|-0.27|0.81|||ANCOVA||This is based on LS Means|Statistical Analysis for CLASI-B (Total Damage)||0.81|-0.27|0.4105
71913139|NCT03371251|143346452|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|4.11||0.8546|TWO_SIDED|90.0|-6.07|7.58|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 210||7.58|-6.07|0.8546
71913140|NCT03371251|143346453|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4455|TWO_SIDED|90.0|-0.63|1.71|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Swelling for Day 210||1.71|-0.63|0.4455
71913141|NCT03371251|143346453|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.9|STANDARD_ERROR_OF_MEAN|0.94||0.3367|TWO_SIDED|90.0|-0.65|2.47|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Tenderness for Day 210||2.47|-0.65|0.3367
71913142|NCT03371251|143346453|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.66||0.255|TWO_SIDED|90.0|-0.34|1.86|||ANCOVA||This is based on LS Means|Statistical Analysis for Sum of Active Joints for Day 210||1.86|-0.34|0.2550
71913143|NCT03371251|143346454|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.8|STANDARD_ERROR_OF_MEAN|0.68||0.2498|TWO_SIDED|90.0|-0.34|1.93|||ANCOVA||This is based on LS Means|||1.93|-0.34|0.2498
71913144|NCT03371251|143346455|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.2558|TWO_SIDED|90.0|-0.02|0.12|||ANCOVA||This is based on LS Means|Statistical Analysis for Day 180||0.12|-0.02|0.2558
71913145|NCT03371251|143346456|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0479|TWO_SIDED|90.0|0.18|0.88|||Log Rank||Hazard rate of BOS161721 120 mg / Hazard rate of placebo|||0.88|0.18|0.0479
71913146|NCT03371251|143346458|SUPERIORITY||Treatment Difference (BOS161721-Placebo)|4.4|STANDARD_ERROR_OF_MEAN|16.4||0.7898|TWO_SIDED|90.0|-22.92|31.7|||ANOVA||This is based on LS Means|||31.70|-22.92|0.7898
71913147|NCT03371251|143346459|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0083|TWO_SIDED|90.0|0.16|0.68|||Log-Rank Test (2-Sided)||Hazard rate of BOS161721 120mg / Hazard rate of placebo|||0.68|0.16|0.0083
71913148|NCT00291187|143346461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|||<|0.001|TWO_SIDED|95.0|-33.1|-9.9|||ANCOVA|||||-9.9|-33.1|<0.001
71913149|NCT00291187|143346461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.3|||<|0.001|TWO_SIDED|95.0|-37.8|-14.7|||ANCOVA|||||-14.7|-37.8|<0.001
71913150|NCT00291187|143346461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.8|||<|0.001|TWO_SIDED|95.0|-34.2|-11.3|||ANCOVA|||||-11.3|-34.2|<0.001
71913151|NCT00291187|143346462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.2||||0.017|TWO_SIDED|95.0|-44.1|-4.3|||ANCOVA|||||-4.3|-44.1|0.017
71913152|NCT00291187|143346462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.7||||0.001|TWO_SIDED|95.0|-53.6|-13.9|||ANCOVA|||||-13.9|-53.6|0.001
71913153|NCT00291187|143346462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4||||0.081|TWO_SIDED|95.0|-37.0|2.1|||ANCOVA|||||2.1|-37.0|0.081
71913154|NCT00291187|143346463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.7||||0.002|TWO_SIDED|95.0|13.0|54.5|||ANCOVA|||||54.5|13.0|0.002
71913155|NCT00291187|143346463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.9|||<|0.001|TWO_SIDED|95.0|27.2|68.6|||ANCOVA|||||68.6|27.2|<0.001
71913156|NCT00291187|143346463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.6||||0.005|TWO_SIDED|95.0|9.1|50.0|||ANCOVA|||||50.0|9.1|0.005
71913157|NCT00291187|143346464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1||||0.006|TWO_SIDED|95.0|-18.9|-3.3|||ANCOVA|||||-3.3|-18.9|0.006
71913158|NCT00291187|143346464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.3|||<|0.001|TWO_SIDED|95.0|-22.1|-6.5|||ANCOVA|||||-6.5|-22.1|<0.001
71913159|NCT00291187|143346464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.3||||0.002|TWO_SIDED|95.0|-20.0|-4.6|||ANCOVA|||||-4.6|-20.0|0.002
71913160|NCT03168555|143346469|EQUIVALENCE|compares visit 1 with visit 2||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71913161|NCT03168555|143346471|EQUIVALENCE|compares visit 1 with visit 2||||||0.63|||||||paired t-test|lognormalized values||compares visit 1 with visit 2||||0.63
71913162|NCT03168555|143346472|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71913163|NCT03168555|143346473|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71913164|NCT03168555|143346474|OTHER|Spearman correlation||||||0.41|||||||Spearman correlation|||||||0.41
71913165|NCT03168555|143346475|OTHER|Spearman correlation||||||0.35|||||||Spearman correlation|||||||0.35
71913166|NCT03168555|143346475|OTHER|||||||0.03|||||||Spearman correlation|||||||0.03
71913167|NCT03168555|143346476|EQUIVALENCE|comparing visit 1 with visit 2||||||0.36|||||||paired t-test|||||||0.36
71913168|NCT03168555|143346477|SUPERIORITY|||||||0.29|||||||paired t-test|||||||0.29
71913169|NCT03168555|143346478|OTHER|Spearman correlation||||||0.73|||||||Spearman correlation|||||||0.73
71913170|NCT03168555|143346478|OTHER|||||||0.77|||||||Spearman correlation|||||||0.77
71913171|NCT03168555|143346479|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
71913172|NCT01515488|143346522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.3|STANDARD_ERROR_OF_MEAN|5.2|<|0.0005|TWO_SIDED|95.0|22.1|42.6|||t-test, 2 sided|DF=331.2||||42.6|22.1|<0.0005
71913173|NCT04445688|143346539|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.2|-4.4|||ANOVA|||||-4.4|-10.2|<0.0001
71913174|NCT04445688|143346540|SUPERIORITY||difference in Least Squares Mean|-21.8|||<|0.0001|TWO_SIDED|95.0|-29.5|-14.1|||ANOVA|||||-14.1|-29.5|<0.0001
71913175|NCT04445688|143346541|SUPERIORITY||difference in Least Squares Mean|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.5|-4.2|||ANOVA|||||-4.2|-10.5|<0.0001
71913176|NCT01262599|143346548|SUPERIORITY|Applies to primary and secondary outcomes: Data were analyzed using one-way analysis of variance, one-way repeated measures analysis of variance, t test, or Mann-Whitney rank sum test, as appropriate. (SigmaStat 3.5; Systat Software, Inc., San Jose, Calif.). Intention-to-treat using last value carried forward was used for missing data.|||||<|0.01|||||||ANOVA|||Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.||||<0.01
71913177|NCT01998399|143346551|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED||||||Chi-squared|||Total enrollment only 25 patients and the study was terminated early due to low enrollment. No further statistical analysis was done.||||0.41
71913178|NCT01269047|143346565|OTHER||Mean Difference (Final Values)|-2.2|STANDARD_DEVIATION|2.4||0.04|TWO_SIDED|95.0|-4.2|-0.2|||ANOVA|||||-0.2|-4.2|0.04
71913179|NCT01269047|143346565|OTHER||Mean Difference (Final Values)|-3.5|STANDARD_DEVIATION|2.7||0.008|TWO_SIDED|95.0|-5.8|-1.3|||ANOVA|||||-1.3|-5.8|0.008
71913180|NCT01269047|143346565|OTHER||Mean Difference (Final Values)|-4.2|STANDARD_DEVIATION|2.6||0.003|TWO_SIDED|95.0|-6.4|-2.0|||ANOVA|||||-2.0|-6.4|0.003
71913181|NCT01269047|143346565|OTHER||Mean Difference (Final Values)|-0.66|STANDARD_DEVIATION|2.0||0.37|TWO_SIDED|95.0|-2.3|0.98|||ANOVA|||||0.98|-2.3|0.37
71913182|NCT01269047|143346566|OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.8||0.2|TWO_SIDED|95.0|-0.21|0.81|||t-test, 2 sided|||||0.81|-0.21|0.2
71913183|NCT01269047|143346566|OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|0.6||0.48|TWO_SIDED|95.0|-0.25|0.5|||t-test, 2 sided|||||0.50|-0.25|0.48
71913184|NCT01269047|143346566|OTHER||Mean Difference (Final Values)|0.23|STANDARD_DEVIATION|0.6||0.18|TWO_SIDED|95.0|-0.12|0.57|||t-test, 2 sided|||||0.57|-0.12|0.18
71913185|NCT01269047|143346566|OTHER||Mean Difference (Final Values)|-0.004|STANDARD_DEVIATION|1.0||1|TWO_SIDED|95.0|-0.62|0.61|||t-test, 2 sided|||||0.61|-0.62|1.0
71913186|NCT05302804|143346599|SUPERIORITY|||||||0.742||||||p-value reflects main effect of treatment.|ANOVA|||"Null hypothesis was there was no difference between menthol gel and control gel~time x trial ANOVA statistical analysis"||||0.742
71913187|NCT05302804|143346600|SUPERIORITY|||||||0.742||||||p-value is main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.742
71913188|NCT05302804|143346601|SUPERIORITY|||||||0.048||||||p-value reflects main effect of menthol|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||0.048
71913189|NCT05302804|143346602|SUPERIORITY|||||||0.104|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.104
71913190|NCT05302804|143346603|SUPERIORITY|||||||0.051|||||||t-test, 2 sided|||The null hypothesis is that there is no difference between menthol and control trials||||.051
71913191|NCT05302804|143346604|SUPERIORITY||||||<|0.001||||||Main effect of treatment|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||< 0.001
71913192|NCT05302804|143346605|SUPERIORITY|||||||0.026|||||||ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.026
71913193|NCT05302804|143346606|SUPERIORITY|||||||0.001||||||p-value at time 30 min of exercise|ANOVA|||The null hypothesis is that there is no difference between menthol and control trials||||.001
71913194|NCT05302804|143346607|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71913195|NCT03250624|143346674|SUPERIORITY||Least Square (LS) Mean Difference|-0.28||||0.632|TWO_SIDED|95.0|-1.46|0.89|||ANCOVA|||||0.89|-1.46|0.632
71683020|NCT04643964|142884136|SUPERIORITY|||||||0.87|||||||ANCOVA|||In this model, the condition included the following levels: entrée, sampler, and control. There was one covariate in this model: QIDS at Time 1.||||.87
71683021|NCT01472939|142884160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.06||||0.128|TWO_SIDED|95.0|-1.743|13.862|||Mixed Models Repeated Measures Analysis|||||13.862|-1.743|0.128
71683022|NCT01472939|142884160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.42||||0.062|TWO_SIDED|95.0|-0.378|15.212|||Mixed Models Repeated Measures Analysis|||||15.212|-0.378|0.062
71683023|NCT01472939|142884160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.83||||0.65|TWO_SIDED|95.0|-6.1|9.765|||Mixed Models Repeated Measures Analysis|||||9.765|-6.100|0.650
71683024|NCT01472939|142884161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.75||||0.102|TWO_SIDED|95.0|-1.344|14.85|||Mixed Models Repeated Measures Analysis|||||14.850|-1.344|0.102
71883061|NCT00385255|143285393|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertussis toxoid (PT) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.74|||||TWO_SIDED|95.0|0.67|0.82|||ANCOVA|||Difference in adjusted GMC ratios for anti-PT antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.||0.82|0.67|
71913196|NCT00948428|143346720|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the PP population were contained within the interval -0.20 to +0.20, and each of these rates was greater than, and statistically different (p\<0.05) from, the Vehicle rate in the ITT population, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent|Mean Difference (Net)|-0.85|||||TWO_SIDED|90.0|-10.84|9.15||||||||9.15|-10.84|
71913197|NCT00948428|143346720|SUPERIORITY|||||||0.0001|||||||ANOVA|||Based on Intent-to-Treat Population||||0.0001
71913198|NCT00948428|143346721|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Partial Clearance rates in the PP population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-12.11|5.95||||||||5.95|-12.11|
71913199|NCT00948428|143346722|EQUIVALENCE|If the 90% confidence interval around the difference between the Generic Imiquimod and Aldara Complete Clearance rates in the ITT population were contained within the interval -0.20 to +0.20, then Generic Imiquimod and Aldara were considered to be therapeutically equivalent.|Mean Difference (Net)|-0.5|||||TWO_SIDED|90.0|-9.92|8.88||||||||8.88|-9.92|
71913200|NCT02408484|143346735|OTHER|||||||0.0028||||||p-value for the change in MCF from baseline to 1 hour post infusion for the firstBLEED population|ANOVA|||||||0.0028
71913201|NCT02408484|143346735|OTHER|||||||0.0002||||||p-value for the change in MCF from baseline to 1 hour post infusion for the BLEED population|ANOVA|||||||0.0002
71913202|NCT04839393|143346771|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|108.86|||||TWO_SIDED|90.0|87.24|135.84|||Mixed Models Analysis|||||135.84|87.24|
71913203|NCT04839393|143346772|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio|113.14|||||TWO_SIDED|90.0|89.34|143.28|||Mixed Models Analysis|||||143.28|89.34|
71913204|NCT04839393|143346773|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|38.73|||||TWO_SIDED|90.0|32.8|45.74|||Mixed Models Analysis|||The test treatment was PF-06865571 300 mg + PF-06882961 200 mg BID (Period 3 - Day 47), which was reported separately in comparison to the reference treatment of PF-06865571 300 mg (Period 1 - Day 1).||45.74|32.80|
71913205|NCT04839393|143346774|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.91|||||TWO_SIDED|90.0|67.95|80.4|||Mixed Models Analysis|||||80.40|67.95|
71913206|NCT04839393|143346775|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|73.2|||||TWO_SIDED|90.0|66.82|80.18|||Mixed Models Analysis|||||80.18|66.82|
71913207|NCT04839393|143346776|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|115.3|||||TWO_SIDED|90.0|85.37|155.73|||Mixed Models Analysis|||||155.73|85.37|
71913208|NCT04839393|143346777|OTHER|The ratio and 90% confidence interval were expressed as percentages|Adjusted Geometric Mean Ratio|118.64|||||TWO_SIDED|90.0|94.05|149.66|||Mixed Models Analysis|||||149.66|94.05|
71913209|NCT00407550|143346835|SUPERIORITY|||||||0.015|||||||Log Rank|||||||0.015
71913210|NCT00407550|143346836|SUPERIORITY|||||||0.56|||||||Log Rank|||||||0.56
71913211|NCT00443846|143346913|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was concluded if the lower bound of the 95% confidence interval of the difference (Group 1 - Group 2) in seroprotection rate was greater than -10%.|Difference (Group 1 - Group 2)|0.0|||||TWO_SIDED|95.0|-3.7|3.7||||||Analysis of non-inferiority was based on the Miettinen and Nurminen method||3.7|-3.7|
71913212|NCT01599806|143346945|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Difference of symp resolution rates|4.0|||||TWO_SIDED|95.0|-2.39|10.42|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin||10.42|-2.39|
71913213|NCT01599806|143346946|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable combined resp rates|6.7|||||TWO_SIDED|95.0|0.3|13.12|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin||13.12|0.30|
71913214|NCT01599806|143346947|NON_INFERIORITY_OR_EQUIVALENCE|-12.5%|Diff of favorable response rates|6.4|||||TWO_SIDED|95.0|0.33|12.36|||Unstratified Miettinen & Nurminen method|||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin||12.36|0.33|
71913215|NCT01599806|143346948|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.4|||||TWO_SIDED|95.0|-2.7|3.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||3.56|-2.70|
71913216|NCT01599806|143346949|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.68|13.81|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.81|0.68|
71869255|NCT04187989|143255839|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.064|STANDARD_ERROR_OF_MEAN|0.176||0.714|TWO_SIDED|95.0|-0.412|0.284|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model||We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|.284|-.412|.714
71869256|NCT04187989|143255840|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.11|STANDARD_ERROR_OF_MEAN|0.212||0.603|TWO_SIDED|95.0|-0.531|0.311|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|: We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.311|-.531|.603
71869257|NCT04187989|143255841|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|0.162|STANDARD_ERROR_OF_MEAN|0.219||0.457|TWO_SIDED|95.0|-0.273|0.597|||Cohen's D|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.597|-.273|.457
71869258|NCT04187989|143255842|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.265|STANDARD_ERROR_OF_MEAN|0.212||0.209|TWO_SIDED|95.0|-0.686|0.156|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects).|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.156|-.686|.209
71869259|NCT04187989|143255843|OTHER|Two-sided test of the null hypothesis of no difference between groups|Cohen's D|-0.107|STANDARD_ERROR_OF_MEAN|0.219||0.623|TWO_SIDED|95.0|-0.541|0.328|||t-test, 2 sided|The p-value is for the coefficient of the treatment/control indicator in the above mixed model|The effect size used is the adjusted Cohen's D, calculated from the coefficient for treatment group in the mixed model, divided by total pooled SD (the square root of the sum of the residual variance+the variance of the group-level random effects)|We fixed linear mixed effects models adjusted for baseline values, balancing factors (age, sex, recreational cannabis), and included a random intercept for group because this is an individually randomized group treatment trial. We tested for treatment effects with a two-sided test of the coefficient for the treatment/control indicator, and estimated Cohen's D (mean difference between the 2 groups at follow-up divided by the total variation not captured by the fixed effects) along with 95% CIs.||.328|-.541|.623
71869260|NCT00092495|143255858|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869261|NCT00092495|143255858|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869262|NCT00092495|143255859|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869263|NCT00092495|143255859|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869264|NCT00092495|143255860|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869265|NCT00092495|143255860|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869266|NCT00092495|143255860|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71913217|NCT01599806|143346950|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.21|1.72|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.72|-1.21|
71913218|NCT01599806|143346951|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.8|||||TWO_SIDED|95.0|2.27|15.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||15.24|2.27|
71913219|NCT01599806|143346952|SUPERIORITY_OR_OTHER||Diff of favorable response rates|10.9|||||TWO_SIDED|95.0|2.86|18.85|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||18.85|2.86|
71869267|NCT00092495|143255861|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869268|NCT00092495|143255861|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869269|NCT00092495|143255861|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869270|NCT00092495|143255862|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71913220|NCT01599806|143346953|SUPERIORITY_OR_OTHER||Diff of favorable response rates|0.2|||||TWO_SIDED|95.0|-1.17|1.68|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||1.68|-1.17|
71869271|NCT00092495|143255862|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869272|NCT00092495|143255863|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
71869273|NCT00092495|143255863|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
71869274|NCT00092495|143255864|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869275|NCT00092495|143255864|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869276|NCT00092495|143255864|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869277|NCT00092495|143255865|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71913221|NCT01599806|143346954|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.3|||||TWO_SIDED|95.0|0.88|13.74|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||13.74|0.88|
71913222|NCT01599806|143346955|SUPERIORITY_OR_OTHER||Diff of favorable response rates|9.7|||||TWO_SIDED|95.0|1.72|17.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||17.55|1.72|
71913223|NCT01599806|143346956|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.4|||||TWO_SIDED|95.0|-4.07|1.02|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.02|-4.07|
71683025|NCT01472939|142884161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.92||||0.031|TWO_SIDED|95.0|0.814|17.021|||Mixed Models Repeated Measures Analysis|||||17.021|0.814|0.031
71869278|NCT00092495|143255865|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group||||||<0.001
71869279|NCT00092495|143255865|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869280|NCT00092495|143255866|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869281|NCT00092495|143255866|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869282|NCT00092495|143255867|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869283|NCT00092495|143255867|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869284|NCT00092495|143255868|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.01||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.01
71869285|NCT00092495|143255868|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869286|NCT00092495|143255868|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869287|NCT00092495|143255869|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869288|NCT00092495|143255869|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869289|NCT00092495|143255869|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869290|NCT00092495|143255870|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869291|NCT00092495|143255870|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869292|NCT00092495|143255871|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869293|NCT00092495|143255871|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869294|NCT00092495|143255872|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869295|NCT00092495|143255872|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869296|NCT00092495|143255872|NON_INFERIORITY_OR_EQUIVALENCE|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001||95.0|||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"||||||<0.001
71869297|NCT00092495|143255873|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869298|NCT00092495|143255873|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869299|NCT00092495|143255873|NON_INFERIORITY_OR_EQUIVALENCE|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001||95.0|||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.||||||<0.001
71869300|NCT04601870|143255882|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $50 arm vs. $0 arm|||3.973|.566|0.4137
71869301|NCT04601870|143255882|SUPERIORITY||Odds Ratio (OR)|1.5||||0.4137|TWO_SIDED|95.0|0.566|3.973|||Chi-squared|Chi squared equals 0.668 with 1 degrees of freedom|Odds ratio for completing counseling in $100 arm vs. $0 arm|||3.973|.566|0.4137
71869302|NCT04601870|143255882|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3383|TWO_SIDED|95.0|0.653|3.446|||Chi-squared|Chi squared equals 0.917 with 1 degrees of freedom|Odds ratio for completing counseling in $50 or $100 arm vs. $0 arm|$0 vs. $50 or $100||3.446|.653|.3383
71869303|NCT04601870|143255883|SUPERIORITY||Odds Ratio (OR)|2.333||||0.265|TWO_SIDED|95.0|0.51|10.6751|||Chi-squared|Chi squared equals 1.243 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 arm vs. $0 arm|||10.6751|.5100|.2650
71869304|NCT04601870|143255883|SUPERIORITY||Odds Ratio (OR)|0.8333||||0.8472|TWO_SIDED|95.0|0.1301|5.3369|||Chi-squared|Chi squared equals 0.037 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $0 arm|||5.3369|.1301|.8472
71683026|NCT01472939|142884161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.71||||0.175|TWO_SIDED|95.0|-2.54|13.957|||Mixed Models Repeated Measures Analysis|||||13.957|-2.540|0.175
71869305|NCT04601870|143255883|SUPERIORITY||Odds Ratio (OR)|1.541||||0.5478|TWO_SIDED|95.0|0.3731|6.364|||Chi-squared|Chi squared equals 0.361 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $50 or $100 arms vs. $0 arm|$0 vs. $50 or $100||6.3640|.3731|.5478
71869306|NCT04601870|143255883|SUPERIORITY||Odds Ratio (OR)|0.3571||||0.2276|TWO_SIDED|95.0|0.06355|2.007|||Chi-squared|Chi squared equals 1.456 with 1 degrees of freedom|Odds ratio for achieving confirmed abstinence at 6 months post-tqd in $100 arm vs. $50 arm|||2.0070|.06355|.2276
71869307|NCT03932812|143255892|SUPERIORITY||Mean Difference (Net)|1.128|STANDARD_ERROR_OF_MEAN|1.622||0.206|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.206
71869308|NCT03932812|143255893|SUPERIORITY||Mean Difference (Final Values)|2.376|STANDARD_ERROR_OF_MEAN|1.793||0.101|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.101
71869309|NCT03932812|143255894|SUPERIORITY||Mean Difference (Net)|-0.201|STANDARD_ERROR_OF_MEAN|1.174||0.836|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.836
71869310|NCT03932812|143255895|SUPERIORITY||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.414||0.567|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|The outcome for this analyses is use of emergency care.||||0.567
71869311|NCT03932812|143255896|SUPERIORITY||Mean Difference (Final Values)|-0.363|STANDARD_ERROR_OF_MEAN|0.165||0.014|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.014
71869312|NCT03932812|143255897|SUPERIORITY||Mean Difference (Final Values)|0.467|STANDARD_ERROR_OF_MEAN|0.301||0.01|TWO_SIDED||||||Chi-squared||Estimated value: presented value is for month 6. Since the outcome measure is count data, a log link function is used. The reported p-value is the significance of the interaction effect between time and intervention.|||||0.010
71869313|NCT03932812|143255898|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|2.682||0.188|TWO_SIDED||||||Regression, Linear|We used generalized estimating equations to fit linear regression model for longitudinal data under the unstructured correlation matrix.|Estimated value: presented value is mean difference at month 6 from BL. Information from month 3 is included in the linear regression model. The reported p-value is the significance of the interaction effect between time and the intervention.|||||0.188
71869314|NCT02585232|143255899|SUPERIORITY|||||||0.483|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline caregiver burden scores were included in the model as covariates.||||||.483
71869315|NCT02585232|143255900|SUPERIORITY|||||||0.169|||||||ANCOVA|Caregiver education, cognitive status of the person with dementia, and baseline Dyadic Adjustment Scale scores were included as covariates.||Only caregivers that were currently or previously in a romantic relationship (e.g., spouses, partners) with the person with dementia reported on the Dyadic Adjustment Scale (i.e., N = 20, n = 9 in CC group and n = 11 in CC+C group).||||0.169
71869316|NCT02585232|143255901|SUPERIORITY|||||||0.763|||||||ANCOVA|Baseline quality of life scores, education, and cognitive status were included as covariates in the model.||||||0.763
71869317|NCT02585232|143255902|SUPERIORITY|||||||0.78|||||||ANCOVA|Baseline depression scores, cognitive status scores (i.e., MoCA), and education were included in the model as covariates.||||||0.780
71869318|NCT02313233|143255906|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71869319|NCT02313233|143255907|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71869320|NCT02313233|143255910|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71869321|NCT02313233|143255911|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 1 sided|||||||<0.05
71869322|NCT01288521|143255970|SUPERIORITY|The null hypothesis is that the tacrolimus biovailability alone is equal to the tacrolimus bioavailability when given with ketoconazole.||||||0.006|||||||Regression, Linear|The bioavailability with Tac alone vs. Tac +keto was compared using linear model adjusting for sex and creatinine clearance.||The bioavailability of Tac alone vs. Tac +keto was compared using a general linear model including sex and creatinine clearance as covariates.||||0.006
71913224|NCT01599806|143346957|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-4.23|4.03|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.03|-4.23|
71913225|NCT01599806|143346958|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.3|||||TWO_SIDED|95.0|-3.71|6.3|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.30|-3.71|
71683027|NCT01472939|142884162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.47||||0.064|TWO_SIDED|95.0|-5.087|0.141|||Mixed Models Repeated Measures Analysis|||||0.141|-5.087|0.064
71683028|NCT01472939|142884162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.017|TWO_SIDED|95.0|-5.818|-0.573|||Mixed Models Repeated Measures Analysis|||||-0.573|-5.818|0.017
71913226|NCT01599806|143346959|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.3|||||TWO_SIDED|95.0|-3.64|0.55|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.55|-3.64|
71683029|NCT01472939|142884162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.114|TWO_SIDED|95.0|-4.813|0.519|||Mixed Models Repeated Measures Analysis|||||0.519|-4.813|0.114
71683030|NCT05070468|142884184|SUPERIORITY|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
71683031|NCT05070468|142884185|SUPERIORITY|||||||0.483|||||||Wilcoxon (Mann-Whitney)|||||||0.483
71683032|NCT05070468|142884186|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
71683033|NCT00308750|142884187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Log Rank|||||||0.40
71683034|NCT00308750|142884187|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Log Rank|||||||0.19
71683035|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.96||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.96
71683036|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15||||||P-value is for the change in Total FACT-L at Cycle 1 (Week 3).|ANCOVA|||||||0.15
71683037|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.92
71683038|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97||||||P-value is for the change in Total FACT-L at Cycle 2 (Week 6).|ANCOVA|||||||0.97
71683039|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.71
71683040|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66||||||P-value is for the change in Total FACT-L at Cycle 3 (Week 9).|ANCOVA|||||||0.66
71683041|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.93
71869323|NCT02679573|143255973|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|-0.2|||||TWO_SIDED|95.0|-4.4|4.1|||||Difference = Difference in responder rates (Delafloxacin treatment group minus Moxifloxacin treatment group). Confidence intervals are calculated using Miettinen and Nurminen method without stratification.|"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125 where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) were presented, and the Miettinen-Nurminen test, without stratification, was used for the 2 sided 95% CI on the difference in response rate."||4.1|-4.4|
71869324|NCT02679573|143255974|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|9.7|||||TWO_SIDED|95.0|3.0|16.3||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||16.3|3.0|
71869325|NCT02679573|143255975|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.3|4.8||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.8|-3.3|
71869326|NCT02679573|143255976|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||TWO_SIDED|95.0|-3.0|4.6||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||4.6|-3.0|
71869327|NCT02679573|143255977|NON_INFERIORITY|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.5|||||TWO_SIDED|95.0|-4.8|5.9||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ -0.125 Ha: Pd - Pm \> -0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."||5.9|-4.8|
71869328|NCT02679573|143255978|OTHER|||||||0.5951||||||The log-rank test was used to compare the time to all-cause mortality between the 2 treatment groups.|Log Rank|||||||0.5951
71869329|NCT00682890|143255979|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANOVA|||P value on change at 3 months for placebo group||||0.63
71869330|NCT00682890|143255979|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANOVA|||||||0.42
71869331|NCT00682890|143255980|SUPERIORITY_OR_OTHER|||||||0.51|||||||ANOVA|||||||0.51
71869332|NCT00682890|143255980|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANOVA|||||||0.03
71869333|NCT03028220|143255982|OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71869334|NCT03028220|143255983|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71913227|NCT01599806|143346960|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.2|||||TWO_SIDED|95.0|-2.03|4.56|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.56|-2.03|
71913228|NCT01599806|143346961|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.2|||||TWO_SIDED|95.0|-2.9|7.24|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.24|-2.90|
71913229|NCT01599806|143346962|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-1.9|||||TWO_SIDED|95.0|-4.3|0.04|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||0.04|-4.30|
71913230|NCT01599806|143346963|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|1.1|||||TWO_SIDED|95.0|-2.07|4.32|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||4.32|-2.07|
71869335|NCT03028220|143255984|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71869336|NCT03028220|143255985|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71913231|NCT01599806|143346964|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|2.0|||||TWO_SIDED|95.0|-2.94|6.91|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||6.91|-2.94|
71913232|NCT01599806|143346965|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|-0.1|||||TWO_SIDED|95.0|-1.99|1.61|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||1.61|-1.99|
71913233|NCT01599806|143346966|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|3.7|||||TWO_SIDED|95.0|0.41|7.16|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||7.16|0.41|
71869337|NCT03028220|143255986|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71869338|NCT03028220|143255987|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
71869339|NCT03028220|143255988|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
71869340|NCT03028220|143255989|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.570
71869341|NCT03028220|143255990|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71869342|NCT03028220|143255991|OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
71869343|NCT03028220|143255992|OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.460
71869344|NCT03028220|143255993|OTHER|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
71869345|NCT02884908|143255994|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.8|||||||Mixed Models Analysis|||||||0.80
71869346|NCT02884908|143255995|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.9|||||||Mixed Models Analysis|||||||0.90
71869347|NCT02884908|143255996|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at baseline (any difference was assumed due to random sampling error).||||||0.38|||||||Mixed Models Analysis|||||||0.38
71869348|NCT00324116|143256007|SUPERIORITY_OR_OTHER||percent responders|85.0||||||95.0|76.0|95.0|||||Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.|||95|76|
71869349|NCT00324116|143256008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.29||||||95.0|-6.83|-1.75|||||95% CI for the change in mean value obtained from one sample t-test.|6 weeks||-1.75|-6.83|
71869350|NCT00324116|143256008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.86||||||95.0|-9.06|-2.67|||||95% CI for the change in mean value obtained from one sample t-test.|12 weeks||-2.67|-9.06|
71869351|NCT00324116|143256008|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.12||||||95.0|-16.28|-5.96|||||95% CI for the change in mean value obtained from one sample t-test.|54 weeks||-5.96|-16.28|
71913234|NCT01599806|143346967|SUPERIORITY_OR_OTHER||Diff of clinical cure rates|4.0|||||TWO_SIDED|95.0|-1.0|9.05|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates||9.05|-1.00|
71869352|NCT00324116|143256009|SUPERIORITY_OR_OTHER||percentage of subjects|5.0||||||95.0|1.61|11.32|||||Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations|||11.32|1.61|
71869353|NCT00324116|143256010|SUPERIORITY_OR_OTHER||percentage of subjects|22.5||||||95.0|14.22|32.11|||||Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||32.11|14.22|
71869354|NCT00324116|143256011|SUPERIORITY_OR_OTHER||percentage of subjects|13.75||||||95.0|7.39|22.24|||||Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||22.24|7.39|
71869355|NCT00324116|143256012|SUPERIORITY_OR_OTHER||percentage of subjects|25.97||||||95.0|16.28|34.81|||||Proportion of subjects progressing to \<=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.|||34.81|16.28|
71869356|NCT01451827|143256043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0127|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0127
71913235|NCT01599806|143346968|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|0.0|||||TWO_SIDED|95.0|-10.4|10.1|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.1|-10.4|
71913236|NCT01599806|143346969|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.4|||||TWO_SIDED|95.0|-7.8|10.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||10.2|-7.8|
71913237|NCT01599806|143346970|SUPERIORITY_OR_OTHER||Diff of clin cure rates in All patients|1.2|||||TWO_SIDED|95.0|-7.5|9.2|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen||9.2|-7.5|
71913238|NCT01599806|143346971|SUPERIORITY_OR_OTHER||Diff of favorable response rates|2.0|||||TWO_SIDED|95.0|-13.18|16.89|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||16.89|-13.18|
71913239|NCT01599806|143346972|SUPERIORITY_OR_OTHER||Diff of favorable response rates|8.0|||||TWO_SIDED|95.0|-10.03|25.21|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||25.21|-10.03|
71913240|NCT01599806|143346973|SUPERIORITY_OR_OTHER||Diff of favorable response rates|7.5|||||TWO_SIDED|95.0|-9.91|24.01|||Unstratified Miettinen & Nurminen method|||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates||24.01|-9.91|
71913241|NCT01599806|143346974|SUPERIORITY_OR_OTHER|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.038
71913242|NCT01599806|143346975|SUPERIORITY_OR_OTHER|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.129
71869357|NCT01451827|143256043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0108|TWO_SIDED|95.0|0.95|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.95|0.0108
71869358|NCT01451827|143256043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.0155|TWO_SIDED|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.00|0.96|0.0155
71913243|NCT01599806|143346976|SUPERIORITY_OR_OTHER|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.080
71913244|NCT01599806|143346977|SUPERIORITY_OR_OTHER|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.||||0.155
71913245|NCT01263314|143347047|OTHER||Mean Difference (Final Values)|-1.25||||0.3551|TWO_SIDED|90.0|-7.01|4.5|||ANOVA|||||4.50|-7.01|0.3551
71913246|NCT01263314|143347047|OTHER||Mean Difference (Final Values)|-1.32||||0.3474|TWO_SIDED|90.0|-7.08|4.48|||ANOVA|||||4.48|-7.08|0.3474
71913247|NCT01263314|143347047|OTHER||Mean Difference (Final Values)|-1.67||||0.3105|TWO_SIDED|90.0|-7.42|4.09|||ANOVA|||||4.09|-7.42|0.3105
71683042|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33||||||P-value is for the change in Total FACT-L at Cycle 4 (Week 12).|ANCOVA|||||||0.33
71913248|NCT01263314|143347047|OTHER||Mean Difference (Final Values)|-6.25||||0.1346|TWO_SIDED|90.0|-15.8|3.27|||ANOVA|||||3.27|-15.8|0.1346
71913249|NCT01263314|143347047|OTHER||Mean Difference (Final Values)|-10.1||||0.0416|TWO_SIDED|90.0|-19.6|-0.56|||ANOVA|||||-0.56|-19.6|0.0416
71913250|NCT01263314|143347047|OTHER||Mean Difference (Final Values)|-8.2||||0.0762|TWO_SIDED|90.0|-17.7|1.32|||ANOVA|||||1.32|-17.7|0.0762
71913251|NCT01263314|143347048|OTHER||Mean Difference (Final Values)|0.47||||0.418|TWO_SIDED|90.0|-3.47|4.41|||ANOVA|||||4.41|-3.47|0.418
71913252|NCT01263314|143347048|OTHER||Mean Difference (Final Values)|4.12||||0.0434|TWO_SIDED|90.0|0.18|8.05|||ANOVA|||||8.05|0.18|0.0434
71913253|NCT01263314|143347048|OTHER||Mean Difference (Final Values)|7.79||||0.0019|TWO_SIDED|90.0|3.85|11.72|||ANOVA|||||11.72|3.85|0.0019
71913254|NCT01263314|143347048|OTHER||Mean Difference (Final Values)|1.15||||0.2223|TWO_SIDED|90.0|-1.42|3.71|||ANOVA|||||3.71|-1.42|0.2223
71913255|NCT01263314|143347048|OTHER||Mean Difference (Final Values)|4.25||||0.0056|TWO_SIDED|90.0|1.69|6.82|||ANOVA|||||6.82|1.69|0.0056
71913256|NCT01263314|143347048|OTHER||Mean Difference (Final Values)|5.4||||0.0012|TWO_SIDED|90.0|2.83|7.96|||ANOVA|||||7.96|2.83|0.0012
71913257|NCT01263314|143347050|OTHER||GMR (Elderly female/Elderly male)|1.23|||||TWO_SIDED|90.0|0.85|1.76|||||GMR = geometric mean ratio|||1.76|0.85|
71869359|NCT01451827|143256043|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.99||||0.2417|TWO_SIDED|95.0|0.97|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||1.01|0.97|0.2417
71869360|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0002|TWO_SIDED|95.0|0.31|0.99|||ANCOVA|||Urinary Frequency||0.99|0.31|0.0002
71869361|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|||<|0.0001|TWO_SIDED|95.0|0.4|1.08|||ANCOVA|||Urinary Frequency||1.08|0.40|< 0.0001
71869362|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.92|||<|0.0001|TWO_SIDED|95.0|0.58|1.25|||ANCOVA|||Urinary Frequency||1.25|0.58|< 0.0001
71869363|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.0004|TWO_SIDED|95.0|0.3|1.01|||ANCOVA|||Urinary Urgency||1.01|0.30|0.0004
71869364|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.0004|TWO_SIDED|95.0|0.29|1.01|||ANCOVA|||Urinary Urgency||1.01|0.29|0.0004
71869365|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.99|||<|0.0001|TWO_SIDED|95.0|0.63|1.34|||ANCOVA|||Urinary Urgency||1.34|0.63|< 0.0001
71869366|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86||||0.0002|TWO_SIDED|95.0|0.42|1.3|||ANCOVA|||Nocturia||1.30|0.42|0.0002
71869367|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.07|||<|0.0001|TWO_SIDED|95.0|0.63|1.51|||ANCOVA|||Nocturia||1.51|0.63|< 0.0001
71869368|NCT01451827|143256044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|||<|0.0001|TWO_SIDED|95.0|0.8|1.66|||ANCOVA|||Nocturia||1.66|0.80|< 0.0001
71869369|NCT01451827|143256045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.97||||0.0209|TWO_SIDED|95.0|0.94|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.||0.99|0.94|0.0209
71869370|NCT01451827|143256045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0287|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0287
71869371|NCT01451827|143256045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.96||||0.0298|TWO_SIDED|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.00|0.93|0.0298
71869372|NCT01451827|143256045|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.98||||0.2306|TWO_SIDED|95.0|0.94|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo||1.01|0.94|0.2306
71869373|NCT00116753|143256056|SUPERIORITY_OR_OTHER||Percentage of partcipants|78.3|||||TWO_SIDED|96.5|69.0|86.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||86|69|
71869374|NCT00116753|143256056|SUPERIORITY_OR_OTHER||Percentage of participants|79.5|||||TWO_SIDED|96.5|71.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|71|
71869375|NCT00116753|143256056|SUPERIORITY_OR_OTHER||Percentage of participants|85.3|||||TWO_SIDED|96.5|77.0|91.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||91|77|
71869376|NCT00116753|143256056|SUPERIORITY_OR_OTHER|||||||0.3022||95.0|||||Mantel Haenszel|||||||0.3022
71869377|NCT00116753|143256056|SUPERIORITY_OR_OTHER|||||||0.7797||95.0|||||Mantel Haenszel|||||||0.7797
71869378|NCT00116753|143256056|SUPERIORITY_OR_OTHER|||||||0.1557||95.0|||||Mantel Haenszel|||||||0.1557
71869379|NCT00116753|143256056|SUPERIORITY_OR_OTHER|||||||0.2208||95.0|||||Mantel Haenszel|||||||0.2208
71869380|NCT00116753|143256057|SUPERIORITY_OR_OTHER||Percentage of participants|80.7|||||TWO_SIDED|96.5|72.0|88.0|||||Estimated value is the percentage of participants with all testosterone values from after Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||88|72|
71869381|NCT00116753|143256057|SUPERIORITY_OR_OTHER||Percentage of participants|80.2|||||TWO_SIDED|96.5|72.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||87|72|
71869382|NCT00116753|143256057|SUPERIORITY_OR_OTHER||Percentage of participants|86.0|||||TWO_SIDED|96.5|78.0|92.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study \<=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||92|78|
71869383|NCT00116753|143256057|SUPERIORITY_OR_OTHER|||||||0.383||95.0|||||Mantel Haenszel|||||||0.3830
71869384|NCT00116753|143256057|SUPERIORITY_OR_OTHER|||||||0.9587||95.0|||||Mantel Haenszel|||||||0.9587
71869385|NCT00116753|143256057|SUPERIORITY_OR_OTHER|||||||0.2579||95.0|||||Mantel Haenszel|||||||0.2579
71869386|NCT00116753|143256057|SUPERIORITY_OR_OTHER|||||||0.2072||95.0|||||Mantel Haenszel|||||||0.2072
71913258|NCT01263314|143347051|OTHER||GMR (Elderly female/Elderly male)|1.08|||||TWO_SIDED|90.0|0.88|1.33||||||||1.33|0.88|
71913259|NCT01263314|143347051|OTHER||GMR (Elderly female/Elderly male)|1.26|||||TWO_SIDED|90.0|1.02|1.55||||||||1.55|1.02|
71913260|NCT01263314|143347051|OTHER||GMR (Elderly female/Elderly male)|1.2|||||TWO_SIDED|90.0|0.98|1.48||||||||1.48|0.98|
71869387|NCT00116753|143256058|SUPERIORITY_OR_OTHER||Percentage of participants|97.3|||||TWO_SIDED|95.0|93.0|99.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||99|93|
71869388|NCT00116753|143256058|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
71913261|NCT01263314|143347054|SUPERIORITY||MK-8266 0.3 mg vs. placebo|9.58||||0.0253|TWO_SIDED|90.0|1.69|17.46|||ANOVA|||||17.46|1.69|0.0253
71913262|NCT01263314|143347054|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-2.59||||0.2856|TWO_SIDED|90.0|-10.5|5.29|||ANOVA|||||5.29|-10.5|0.2856
71913263|NCT01263314|143347054|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-4.06||||0.1895|TWO_SIDED|90.0|-11.9|3.82|||ANOVA|||||3.82|-11.9|0.1895
71683043|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.19
71869389|NCT00116753|143256058|SUPERIORITY_OR_OTHER||Percentage of participants|97.9|||||TWO_SIDED|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone \<=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.|||100|94|
71869390|NCT01642251|143256062|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|80.0|0.22|0.51||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients within the male/abnormal LDH stratum||0.51|0.22|<0.001
71869391|NCT01642251|143256062|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.18|TWO_SIDED|80.0|0.6|1.09||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients not in the male/abnormal LDH stratum.||1.09|0.60|0.18
71869392|NCT01642251|143256062|SUPERIORITY|||||||0.028||||||p value for the interaction by treatment and stratification factor|Regression, Cox|||If there was a significant treatment-by-stratification factor interaction, the results would be reported separately for each stratum. Significance was defined as the p value was less than 0.05.||||0.028
71869393|NCT01642251|143256063|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.17|TWO_SIDED|80.0|0.64|1.07|||Regression, Cox|stratified on the stratification factors used for randomization||||1.07|0.64|0.17
71869394|NCT01642251|143256065|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||0.13
71869395|NCT01445301|143256066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.0|||<|0.001|TWO_SIDED|95.0|-15.0|-7.0|||ANCOVA|||||-7.0|-15.0|<0.001
71869396|NCT01445301|143256066|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-12.9|-3.6|||ANCOVA|||||-3.6|-12.9|<0.001
71869397|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.4|-1.5|||ANCOVA|||WEEK 1||-1.5|-4.4|<0.001
71869398|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-1.8||||0.113|TWO_SIDED|95.0|-4.0|0.4|||ANCOVA|||WEEK 2||0.4|-4.0|0.113
71869399|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.0||||0.084|TWO_SIDED|95.0|-4.2|0.3|||ANCOVA|||WEEK 4||0.3|-4.2|0.084
71869400|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.7||||0.026|TWO_SIDED|95.0|-5.1|-0.3|||ANCOVA|||WEEK 8||-0.3|-5.1|0.026
71869401|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.6||||0.03|TWO_SIDED|95.0|-5.0|-0.3|||ANCOVA|||WEEK 12||-0.3|-5.0|0.030
71869402|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-3.4||||0.028|TWO_SIDED|95.0|-6.5|-0.4|||ANCOVA|||WEEK 1||-0.4|-6.5|0.028
71869403|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.4||||0.004|TWO_SIDED|95.0|-9.1|-1.7|||ANCOVA|||WEEK 2||-1.7|-9.1|0.004
71869404|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Odds Ratio (OR)|-5.8||||0.003|TWO_SIDED|95.0|-9.6|-1.9|||ANCOVA|||WEEK 4||-1.9|-9.6|0.003
71869405|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.5||||0.006|TWO_SIDED|95.0|-9.4|-1.6|||ANCOVA|||WEEK 8||-1.6|-9.4|0.006
71913264|NCT01263314|143347054|SUPERIORITY||MK-8266 0.3 mg vs. placebo|-4.16||||0.1157|TWO_SIDED|90.0|-10.0|1.7|||ANOVA|||||1.70|-10.0|0.1157
71913265|NCT01263314|143347054|SUPERIORITY||MK-8266 0.6 mg vs. placebo|-11.7||||0.0018|TWO_SIDED|90.0|-17.5|-5.79|||ANOVA|||||-5.79|-17.5|0.0018
71913266|NCT01263314|143347054|SUPERIORITY||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-10.6||||0.0034|TWO_SIDED|90.0|-16.5|-4.77|||ANOVA|||||-4.77|-16.5|0.0034
71869406|NCT01445301|143256068|NON_INFERIORITY|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.6||||0.005|TWO_SIDED|95.0|-9.5|-1.7|||ANCOVA|||WEEK 12||-1.7|-9.5|0.005
71869407|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-2.5|||<|0.001|TWO_SIDED|95.0|-3.9|-1.1|||ANCOVA|||WEEK 1||-1.1|-3.9|<0.001
71683044|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||P-value is for the change in Total FACT-L at Cycle 5 (Week 15).|ANCOVA|||||||0.40
71869408|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.001|TWO_SIDED|95.0|-4.7|-1.6|||ANCOVA|||WEEK 2||-1.6|-4.7|<0.001
71869409|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-2.5||||0.002|TWO_SIDED|95.0|-4.1|-0.9|||ANCOVA|||WEEK 4||-0.9|-4.1|0.002
71869410|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-2.7||||0.003|TWO_SIDED|95.0|-4.5|-0.9|||ANCOVA|||WEEK 8||-0.9|-4.5|0.003
71869411|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-2.8||||0.002|TWO_SIDED|95.0|-4.6|-1.0|||ANCOVA|||WEEK 12||-1.0|-4.6|0.002
71869412|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.8|-3.2|||ANCOVA|||WEEK 1||-3.2|-8.8|<0.001
71869413|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-8.1|||<|0.001|TWO_SIDED|95.0|-11.4|-4.7|||ANCOVA|||WEEK 2||-4.7|-11.4|<0.001
71683045|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.63
71683046|NCT00308750|142884191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P-value is for the change in Total FACT-L at Cycle 6 (Week 18).|ANCOVA|||||||0.55
71683047|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.93
71869414|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-9.7|||<|0.001|TWO_SIDED|95.0|-13.1|-6.2|||ANCOVA|||WEEK 4||-6.2|-13.1|<0.001
71869415|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-8.6|||<|0.001|TWO_SIDED|95.0|-12.1|-5.1|||ANCOVA|||WEEK 8||-5.1|-12.1|<0.001
71869416|NCT01445301|143256068|SUPERIORITY||Mean Difference (Net)|-8.2|||<|0.001|TWO_SIDED|95.0|-11.6|-4.8|||ANCOVA|||WEEK 12||-4.8|-11.6|<0.001
71869417|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.71|||<|0.001|TWO_SIDED|95.0|-11.3|-4.12|||ANCOVA|||Total Lesion Counts, WEEK 1||-4.12|-11.30|<0.001
71869418|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.51|||<|0.001|TWO_SIDED|95.0|-13.24|-3.77|||ANCOVA|||Total Lesion Counts, WEEK 2||-3.77|-13.24|<0.001
71869419|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.89|||<|0.001|TWO_SIDED|95.0|-13.37|-4.41|||ANCOVA|||Total Lesion Counts, WEEK 4||-4.41|-13.37|<0.001
71869420|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.12|||<|0.001|TWO_SIDED|95.0|-13.82|-4.43|||ANCOVA|||Total Lesion Counts, WEEK 8||-4.43|-13.82|<0.001
71869421|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.43|||<|0.001|TWO_SIDED|95.0|-14.11|-4.75|||ANCOVA|||Total Lesion Counts, WEEK 12||-4.75|-14.11|<0.001
71869422|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-10.54|||<|0.001|TWO_SIDED|95.0|-15.12|-5.97|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-5.97|-15.12|<0.001
71869423|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.21||||0.011|TWO_SIDED|95.0|-12.73|-1.69|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-1.69|-12.73|0.011
71869424|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-7.64||||0.005|TWO_SIDED|95.0|-12.93|-2.35|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-2.35|-12.93|0.005
71869425|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.73||||0.002|TWO_SIDED|95.0|-14.2|-3.26|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.26|-14.20|0.002
71869426|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.2||||0.002|TWO_SIDED|95.0|-13.34|-3.06|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-3.06|-13.34|0.002
71869427|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-5.8||||0.011|TWO_SIDED|95.0|-10.29|-1.32|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-1.32|-10.29|0.011
71869428|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.3||||0.005|TWO_SIDED|95.0|-14.1|-2.5|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-2.50|-14.10|0.005
71869429|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.27|||<|0.001|TWO_SIDED|95.0|-14.72|-3.83|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-3.83|-14.72|<0.001
71869430|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.84||||0.002|TWO_SIDED|95.0|-14.28|-3.39|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-3.39|-14.28|0.002
71869431|NCT01445301|143256069|NON_INFERIORITY_OR_EQUIVALENCE|If the upper 95% confidence was less than the pre-defined threshold (-Δ \[non-inferiority margin, -3.8\]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.68|||<|0.001|TWO_SIDED|95.0|-15.06|-4.3|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-4.30|-15.06|<0.001
71869432|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-8.9|||<|0.001|TWO_SIDED|95.0|-12.32|-5.48|||ANCOVA|||Total Lesion Counts, WEEK 1||-5.48|-12.32|<0.001
71869433|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-11.17|||<|0.001|TWO_SIDED|95.0|-15.18|-7.16|||ANCOVA|||Total Lesion Counts, WEEK 2||-7.16|-15.18|<0.001
71869434|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-12.12|||<|0.001|TWO_SIDED|95.0|-15.9|-8.35|||ANCOVA|||Total Lesion Counts, WEEK 4||-8.35|-15.90|<0.001
71869435|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-11.33|||<|0.001|TWO_SIDED|95.0|-15.37|-7.3|||ANCOVA|||Total Lesion Counts, WEEK 8||-7.30|-15.37|<0.001
71869436|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-11.18|||<|0.001|TWO_SIDED|95.0|-15.11|-7.25|||ANCOVA|||Total Lesion Counts, WEEK 12||-7.25|-15.11|<0.001
71869437|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-8.32|||<|0.001|TWO_SIDED|95.0|-12.76|-3.88|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1||-3.88|-12.76|<0.001
71869438|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-9.57|||<|0.001|TWO_SIDED|95.0|-13.83|-5.3|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2||-5.30|-13.83|<0.001
71869439|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-7.83|||<|0.001|TWO_SIDED|95.0|-12.03|-3.62|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4||-3.62|-12.03|<0.001
71869440|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-8.08|||<|0.001|TWO_SIDED|95.0|-12.63|-3.53|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8||-3.53|-12.63|<0.001
71869441|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-8.56|||<|0.001|TWO_SIDED|95.0|-12.71|-4.41|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12||-4.41|-12.71|<0.001
71869442|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-9.11|||<|0.001|TWO_SIDED|95.0|-13.53|-4.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1||-4.68|-13.53|<0.001
71869443|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-11.05|||<|0.001|TWO_SIDED|95.0|-16.3|-5.8|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2||-5.80|-16.30|<0.001
71869444|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-14.17|||<|0.001|TWO_SIDED|95.0|-18.97|-9.37|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4||-9.37|-18.97|<0.001
71869445|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-13.04|||<|0.001|TWO_SIDED|95.0|-17.83|-8.25|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8||-8.25|-17.83|<0.001
71869446|NCT01445301|143256069|SUPERIORITY||Mean Difference (Net)|-12.37|||<|0.001|TWO_SIDED|95.0|-17.05|-7.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12||-7.68|-17.05|<0.001
71869447|NCT01445301|143256070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71869448|NCT01445301|143256070|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71683048|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||P-value is for the change in Total FACT-Taxane at Cycle 1 (Week 3).|ANCOVA|||||||0.86
71869449|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1||||0.470
71869450|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2||||0.844
71869451|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4||||0.022
71869452|NCT01445301|143256071|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
71869453|NCT01445301|143256071|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
71869454|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.572||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1||||0.572
71869455|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.335||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2||||0.335
71869456|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.187||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4||||0.187
71869457|NCT01445301|143256071|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8||||<0.001
71869458|NCT01445301|143256071|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12||||0.006
71869459|NCT01445301|143256072|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1||||0.002
71869460|NCT01445301|143256072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2||||<0.001
71869461|NCT01445301|143256072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4||||<0.001
71869462|NCT01445301|143256072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8||||<0.001
71869463|NCT01445301|143256072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12||||<0.001
71913267|NCT00282568|143347055|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% Confidence Interval for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|94.97|||||TWO_SIDED|90.0|90.72|99.41|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||99.41|90.72|
71913268|NCT00282568|143347057|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.15|||||TWO_SIDED|90.0|82.69|93.96|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmax. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmax prior to analysis and the results were transformed back to the original scale for the presentation of results.||93.96|82.69|
71913269|NCT00282568|143347058|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|87.2|||||TWO_SIDED|90.0|82.72|91.93|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||91.93|82.72|
71913270|NCT01585168|143347078|OTHER||Mean Difference (Net)|2.4109||||0.032|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided|A Paired t-test was performed to explore the difference between two groups.|FHN was found to have lower mean BOLD activation while given drug compared to placebo in amygdala.|||||0.032
71913271|NCT01585168|143347078|OTHER||Median Difference (Net)|3.6615||||0.125|TWO_SIDED||||||t-test, 2 sided|||||||0.125
71913272|NCT01585168|143347081|OTHER||Mean Difference (Net)|2.7264||||0.356|TWO_SIDED|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided||FHP was found to have lower mean BOLD activation while given drug compared to placebo in anterior cingulate cortex.|||||0.356
71913273|NCT01585168|143347081|OTHER||Median Difference (Net)|1.8348||||0.009|TWO_SIDED||||||t-test, 2 sided|||||||0.009
71683049|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.69
71683050|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||P-value is for the change in Total FACT-Taxane at Cycle 2 (Week 6).|ANCOVA|||||||0.77
71683051|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.83
71913274|NCT03326583|143347105|SUPERIORITY|||||||0.05|||||||Fisher Exact|||||||.05
71913275|NCT03326583|143347106|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71913276|NCT03326583|143347107|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71913277|NCT03326583|143347108|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||||||.05
71683052|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||||||P-value is for the change in Total FACT-Taxane at Cycle 3 (Week 9).|ANCOVA|||||||0.78
71683053|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||1.00
71683054|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||P-value is for the change in Total FACT-Taxane at Cycle 4 (Week 12).|ANCOVA|||||||0.91
71869464|NCT01445301|143256072|SUPERIORITY_OR_OTHER|||||||0.48|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 1||||0.480
71869465|NCT01445301|143256072|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 2||||<0.001
71869466|NCT01445301|143256072|SUPERIORITY_OR_OTHER|||||||0.009|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 4||||0.009
71869467|NCT01445301|143256072|SUPERIORITY_OR_OTHER|||||||0.008|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 8||||0.008
71869468|NCT01445301|143256072|SUPERIORITY_OR_OTHER|||||||0.065|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 12||||0.065
71869469|NCT04493502|143256098|SUPERIORITY||Mean Difference (Final Values)|17.1||||0.189|TWO_SIDED|95.0|-7.3|41.4|||Regression, Logistic|||||41.4|-7.3|0.189
71869470|NCT04493502|143256099|SUPERIORITY||Mean Difference (Final Values)|-4.67||||0.024|TWO_SIDED|95.0|-8.69|-0.64|||ANCOVA|||||-0.64|-8.69|0.024
71869471|NCT04493502|143256100|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.949|TWO_SIDED|95.0|-1.44|1.53|||ANCOVA|||||1.53|-1.44|0.949
71869472|NCT02891837|143256103|OTHER|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.4930
71869473|NCT02891837|143256105|OTHER|||||||0.1924|||||||Wilcoxon (Mann-Whitney)|||||||0.1924
71869474|NCT02891837|143256106|OTHER|||||||0.8678|||||||Wilcoxon (Mann-Whitney)|||||||0.8678
71869475|NCT02891837|143256113|OTHER|||||||0.6422|||||||Wilcoxon (Mann-Whitney)|||||||0.6422
71869476|NCT02891837|143256114|OTHER|||||||0.7572|||||||Wilcoxon (Mann-Whitney)|||||||0.7572
71869477|NCT02891837|143256116|OTHER|||||||0.3681|||||||Wilcoxon (Mann-Whitney)|||||||0.3681
71683055|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.49
71869478|NCT02891837|143256120|OTHER|"Sample size calculated with nQuery 7.0. Assumed standard deviation = 50 h, \& mean values of 44 h (placebo) \& 14 h (L-citrulline group), estimated effect size = 0.600, yielding a sample size N=92/group (two-sided Wilcoxon-rank-sum test with 0.01 significance level and 90% power). Assumptions for standard deviation \& mean based on Study CIT-002-01 results.~To allow for subjects being enrolled but not assigned to the full analysis set (FAS), an overall N=95 subjects per group were to be enrolled."|Location shift|219.0||||0.156|TWO_SIDED|95.0|-88.0|626.0||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)||Treatment difference = L-citrulline - placebo For the mean and median values, that the estimated values are given in minutes \[min\]|H0: Composite endpoint in L-citrulline group = placebo group H1: Composite endpoint in L-citrulline group ≠ placebo group H0 tested using Wilcoxon-rank-sum test. Significance level = 1% (2-sided).||626.0|-88.0|0.1560
71869479|NCT02891837|143256120|OTHER||Location shift|813.1||||0.1627|TWO_SIDED|95.0|-335.5|1961.6||The threshold for statistical significance was 0.05.|t-test, 2 sided|The results of the T-test should be interpreted with caution since the endpoint is not normally distributed.|Treatment difference = L-citrulline - placebo. For the mean and median values, the estimated values are given in minutes|Post hoc analyses were done for US patients on mechanical ventilation for \<=48 hours. For all post hoc analyses a significance level of 5% was applied.||1961.6|-335.5|0.1627
71869480|NCT02891837|143256128|OTHER|||||||0.0326||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for all US patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0326
71869481|NCT02891837|143256128|OTHER|||||||0.0026||||||The threshold for statistical significance was 0.05.|ANOVA|||"Values at 48 hours post-surgery start for ALL patients on ventilation for ≤48 hours are presented.~Treatment group, baseline values and site were included as fixed factors, site\*treatment as interaction terms in this ANOVA. The normality assumption of residuals is critical for all considered timepoints. Please interpret results with caution."||||0.0026
71869482|NCT02751320|143256137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09||||0.7603|TWO_SIDED|95.0|-8.11|5.94||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||5.94|-8.11|0.7603
71869483|NCT02751320|143256137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.3555|TWO_SIDED|95.0|-10.34|3.74||From ANCOVA: Participant (random), treatment \& period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||3.74|-10.34|0.3555
71869484|NCT02751320|143256137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.21||||0.5335|TWO_SIDED|95.0|-4.81|9.23||ANCOVA: Participant (random), treatment \& period (fixed), Participant-level baseline SMH, period-level baseline SMH, Participant-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates)|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|||9.23|-4.81|0.5335
71683056|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.53||||||P-value is for the change in Total FACT-Taxane at Cycle 5 (Week 15).|ANCOVA|||||||0.53
71683057|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.80
71869485|NCT02751320|143256137|SUPERIORITY_OR_OTHER||Mean Difference (Net)|22.96|||<|0.0001|TWO_SIDED|95.0|16.02|29.9||From ANCOVA: Participant (random), treatment \& period (fixed), Participant -level baseline SMH, period-level baseline SMH, Participant -level pre-treatment acidchallenge SMH and period-level pre-treatment acid challenge SMH (covariates) .|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|Treatment comparison corresponding to qualifying criteria for the analysis||29.90|16.02|<.0001
71869486|NCT01942590|143256243|OTHER|||||||0.0512|||||||t-test, 1 sided|||||||0.0512
71869487|NCT01942590|143256243|OTHER|||||||0.434|||||||t-test, 1 sided|||||||0.434
71869488|NCT01942590|143256244|OTHER|||||||0.0816||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.0816
71869489|NCT01942590|143256244|OTHER|||||||0.3318||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.3318
71869490|NCT01942590|143256245|OTHER|||||||0.2074|||||||t-test, 1 sided|||||||0.2074
71869491|NCT01942590|143256245|OTHER|||||||0.332|||||||t-test, 1 sided|||||||0.332
71683058|NCT00308750|142884192|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85||||||P-value is for the change in Total FACT-Taxane at Cycle 6 (Week 18).|ANCOVA|||||||0.85
71683059|NCT00308750|142884193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87|||||||Log Rank|||||||0.87
71683060|NCT00308750|142884193|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Log Rank|||||||0.05
71683061|NCT00308750|142884196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Log Rank|||||||0.71
71683062|NCT00308750|142884196|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Log Rank|||||||0.04
71869492|NCT01942590|143256246|OTHER|||||||0.233||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.233
71869493|NCT01942590|143256246|OTHER|||||||0.142||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided|||||||0.142
71869494|NCT01942590|143256247|OTHER|||||||0.019|||||||t-test, 1 sided|||||||0.019
71869495|NCT01942590|143256247|OTHER|||||||0.366|||||||t-test, 1 sided|||||||0.366
71869496|NCT01942590|143256248|OTHER|||||||0.161|||||||t-test, 1 sided|||||||0.161
71683063|NCT00388297|142884207|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|-3|0.71
71869497|NCT01942590|143256248|OTHER|||||||0.43|||||||t-test, 1 sided|||||||0.43
71869498|NCT01942590|143256249|OTHER|||||||0.01|||||||t-test, 1 sided|||Baseline, week 18||||0.01
71869499|NCT01942590|143256249|OTHER|||||||0.004|||||||t-test, 1 sided|||Baseline, week 52||||0.004
71869500|NCT01942590|143256249|OTHER|||||||0.154|||||||t-test, 1 sided|||Baseline, week 18||||0.154
71869501|NCT01942590|143256249|OTHER|||||||0.211|||||||t-test, 1 sided|||Baseline, Week 52||||0.211
71869502|NCT01942590|143256250|OTHER|||||||0.006|||||||t-test, 1 sided|||Baseline, Week 18||||0.006
71869503|NCT01942590|143256250|OTHER|||||||0.007|||||||t-test, 1 sided|||Baseline, Week 52||||0.007
71869504|NCT01942590|143256250|OTHER|||||||0.297|||||||t-test, 1 sided|||Baseline, Week 18||||0.297
71869505|NCT01942590|143256250|OTHER|||||||0.196|||||||t-test, 1 sided|||Baseline, Week 52||||0.196
71869506|NCT01942590|143256251|OTHER|||||||0.3639|||||||t-test, 1 sided|||Baseline Week 18||||0.3639
71869507|NCT01942590|143256251|OTHER|||||||0.0371|||||||t-test, 1 sided|||Baseline, Week 52||||0.0371
71869508|NCT01942590|143256252|OTHER|||||||0.268|||||||t-test, 1 sided|||Baseline, Week 18||||0.268
71913278|NCT01525667|143347131|SUPERIORITY_OR_OTHER||Least Square Means (LSM) Difference|25.74|STANDARD_ERROR_OF_MEAN|8.94||0.0067|TWO_SIDED|95.0|7.61|43.86|||Mixed Models Analysis||LSM difference =LSM Low dose - LSM Placebo|||43.86|7.61|0.0067
71913279|NCT01525667|143347131|SUPERIORITY_OR_OTHER||Least Square Means (LSM) difference|14.93|STANDARD_ERROR_OF_MEAN|10.8||0.18|TWO_SIDED|95.0|-7.12|36.99|||Mixed Models Analysis||LSM difference= LSM High Dose - LSM Placebo|||36.99|-7.12|0.18
71913280|NCT01525667|143347132|SUPERIORITY_OR_OTHER||LSM Difference|18.03|STANDARD_ERROR_OF_MEAN|5.97||0.004|TWO_SIDED|95.0|6.03|30.02|||Mixed Models Analysis|||||30.02|6.03|0.004
71913281|NCT01525667|143347132|SUPERIORITY_OR_OTHER||LSM difference|9.23|STANDARD_ERROR_OF_MEAN|6.91||0.19|TWO_SIDED|95.0|-4.72|23.17|||Mixed Models Analysis|||||23.17|-4.72|0.19
71913282|NCT01525667|143347133|SUPERIORITY_OR_OTHER||LSM Difference|6.45|STANDARD_ERROR_OF_MEAN|4.64||0.19|TWO_SIDED|95.0|-3.5|16.41|||ANCOVA|||||16.41|-3.50|0.19
71913283|NCT01525667|143347133|SUPERIORITY_OR_OTHER||LSM difference|5.49|STANDARD_ERROR_OF_MEAN|4.56||0.25|TWO_SIDED|95.0|-4.29|15.26|||ANCOVA|||||15.26|-4.29|0.25
71869509|NCT01942590|143256252|OTHER|||||||0.0036|||||||t-test, 1 sided|||Baseline, Week 52||||0.0036
71869510|NCT01942590|143256252|OTHER|||||||0.286|||||||t-test, 1 sided|||Baseline, Week 18||||0.286
71869511|NCT01942590|143256252|OTHER|||||||0.279|||||||t-test, 1 sided|||Baseline, Week 52||||0.279
71869512|NCT01942590|143256253|OTHER|||||||0.479|||||||t-test, 1 sided|||Baseline, Week 18||||0.479
71869513|NCT01942590|143256253|OTHER|||||||0.059|||||||t-test, 1 sided|||Baseline, Week 52||||0.059
71869514|NCT01942590|143256253|OTHER|||||||0.152|||||||t-test, 1 sided|||Baseline, Week 18||||0.152
71869515|NCT01942590|143256253|OTHER|||||||0.118|||||||t-test, 1 sided|||Baseline, Week 52||||0.118
71869516|NCT03616977|143256258|EQUIVALENCE|Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of geometric least squares means|1.01|||||TWO_SIDED|90.0|0.961|1.06||||||||1.06|0.961|
71869517|NCT01323972|143256269|OTHER||GMT ratio|1.32|||||TWO_SIDED|95.0|1.06|1.65|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 2 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.65|1.06|
71683064|NCT00388297|142884207|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimate|-1.0||||0.3|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-4|0.30
71869518|NCT01323972|143256269|OTHER||GMT ratio|1.06|||||TWO_SIDED|95.0|0.85|1.32|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.32|0.85|
71869519|NCT01323972|143256269|OTHER||GMT ratio|0.8||||||95.0|0.64|1.0|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within \[0.5, 2\].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 2 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1|0.64|
71869520|NCT01323972|143256269|NON_INFERIORITY|Non-inferiority was demonstrated if one month post Dose 3, the upper limit (UL) of the 2-sided 95% CI of the GMT ratio of the pilot scale lot (Control Group) over the pooled commercial scale lots (Pooled Log Group) was below 2.|GMT ratio|0.95||||||95.0|0.79|1.15||||||Demonstration of non-inferiority of the commercial scale lots of GSK 257049 to the pilot scale lot in terms of anti-Circumsporozoite (anti-CS) immunogenicity.||1.15|0.79|
71913284|NCT01525667|143347134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.19||0.4|TWO_SIDED|95.0|-0.21|0.53|||Mixed Models Analysis|||||0.53|-0.21|0.4
71913285|NCT01525667|143347134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.011|STANDARD_ERROR_OF_MEAN|0.2||0.96|TWO_SIDED||||||Mixed Models Analysis|||||||0.96
71913286|NCT01525667|143347135|SUPERIORITY_OR_OTHER||LSM difference|16.81|STANDARD_ERROR_OF_MEAN|8.37||0.05|TWO_SIDED|95.0|0.16|33.47|||Mixed Models Analysis|||||33.47|0.16|0.05
71913287|NCT01525667|143347135|SUPERIORITY_OR_OTHER||LSM difference|10.7|STANDARD_ERROR_OF_MEAN|9.01||0.24|TWO_SIDED|95.0|-7.26|28.65|||Mixed Models Analysis|||||28.65|-7.26|0.24
71913288|NCT01784614|143347141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.96||||0.908|TWO_SIDED|90.0|0.56|1.65|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.|||1.65|0.56|0.908
71683065|NCT00388297|142884208|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71683066|NCT00388297|142884208|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71869521|NCT01850446|143256367|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|8.56|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (patient diary analysis)||||<0.0001
71913289|NCT01784614|143347141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.67||||0.083|TWO_SIDED|90.0|0.45|0.98|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.|||0.98|0.45|0.083
71913290|NCT01784614|143347141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.53||||0.01|TWO_SIDED|90.0|0.36|0.78|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.|||0.78|0.36|0.010
71913291|NCT01784614|143347141|SUPERIORITY_OR_OTHER||Ratio of Geometric LS mean|0.3|||<|0.001|TWO_SIDED|90.0|0.18|0.51|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.|||0.51|0.18|<0.001
71913292|NCT01235507|143347147|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71913293|NCT01235507|143347147|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71913294|NCT01235507|143347147|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71913295|NCT01235507|143347149|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71913296|NCT01235507|143347149|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71869522|NCT01850446|143256367|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|7.31|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (physician's examination analysis)||||<0.0001
71869523|NCT01850446|143256368|NON_INFERIORITY|Non-inferiority margin was prespecified as 1.2 degree\*day|Mean Difference (Final Values)|0.44||||0.027|ONE_SIDED|97.5|-0.23||||t-test, 1 sided|||Severity of fever was measured as area under curve (body temperature-time)|||-0.23|0.027
71869524|NCT01850446|143256369|NON_INFERIORITY|Non-inferiority magrin was prespecified as 20% of comparator duration|Mean Difference (Final Values)|0.23||||0.02|ONE_SIDED|97.5||0.63|||t-test, 1 sided|mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom||||0.63||0.02
71869525|NCT01850446|143256370|NON_INFERIORITY|Non-inferiority margin was prespecified as 20% (on each day)|Z-value|6.95|||<|0.0001|TWO_SIDED|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics||||<0.0001
71869526|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.49|||<|0.001|ONE_SIDED|97.5||1.33|||t-test, 1 sided|||Severity of influenza symptoms (day1 morning)||1.33||<0.001
71869527|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.56||||0.013|ONE_SIDED|97.5||2.59|||t-test, 1 sided|||Severity of influenza symptoms (day2 morning)||2.59||0.013
71869528|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.82||||0.084|ONE_SIDED|97.5||2.66|||t-test, 1 sided|||Severity of influenza symptoms (day3 morning)||2.66||0.084
71869529|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.62||||0.22|ONE_SIDED|97.5||2.2|||t-test, 1 sided|||Severity of influenza symptoms (day4 morning)||2.2||0.22
71869530|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.04|ONE_SIDED|97.5||1.07|||t-test, 1 sided|||Severity of influenza symptoms (day5 morning)||1.07||0.04
71869531|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.13|ONE_SIDED|97.5||0.98|||t-test, 1 sided|||Severity of influenza symptoms (day6 morning)||0.98||0.13
71869532|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25||||0.135|ONE_SIDED|97.5||0.74|||t-test, 1 sided|||severity of influenza symptoms (day1 morning)||0.74||0.135
71869533|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.64||||0.004|ONE_SIDED|97.5||2.67|||t-test, 1 sided|||Severity of influenza symptoms (day1 evening)||2.67||0.004
71869534|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.9||||0.05|ONE_SIDED|97.5||2.94|||t-test, 1 sided|||Severity of influenza symptoms (day2 evening)||2.94||0.05
71869535|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.447|ONE_SIDED|97.5||3.08|||t-test, 1 sided|||Severity of influenza symptoms (day3 evening)||3.08||0.447
71869536|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08||||0.042|ONE_SIDED|97.5||1.4|||t-test, 1 sided|||Severity of influenza symptoms (day4 evening)||1.4||0.042
71869537|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.29||||0.313|ONE_SIDED|97.5||1.53|||t-test, 1 sided|||Severity of influenza symptoms (day5 evening)||1.53||0.313
71869538|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27||||0.087|ONE_SIDED|97.5||0.77|||t-test, 1 sided|||Severity of influenza symptoms (day6 evening)||0.77||0.087
71869539|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.43|||<|0.001|ONE_SIDED|97.5||1.41|||t-test, 1 sided|||Severity of influenza symptoms (day1 physician's objective examination)||1.41||<0.001
71869540|NCT01850446|143256371|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.305|ONE_SIDED|97.5||3.11|||t-test, 1 sided|||Severity of influenza symptoms (day3 physician's objective examination)||3.11||0.305
71869541|NCT01850446|143256372|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.08||||0.02|ONE_SIDED|97.5||0.5|||t-test, 1 sided|||Fever duration||0.5||0.02
71869542|NCT01850446|143256372|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.18|||<|0.001|ONE_SIDED|97.5||0.14|||t-test, 1 sided|||Non-specific symptoms duration||0.14||<0.001
71869543|NCT01850446|143256372|NON_INFERIORITY|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.001|ONE_SIDED|97.5||0.11|||t-test, 1 sided|||Nasal/ throat/ chest symptoms duration||0.11||<0.001
71869544|NCT01850446|143256373|NON_INFERIORITY|N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)|AUC ratio|1.04||||0.015|TWO_SIDED|95.0|0.9|1.17||bootstrap (100000 rep) confidence limits were constructed for AUC ratio|one-sample Z-test|AUC ratio was compared with N.I. margin||Severity of influenza was measured as area under curve (symptoms score-time)||1.17|0.9|0.015
71913297|NCT01235507|143347149|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71913298|NCT01235507|143347150|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71683067|NCT00388297|142884209|SUPERIORITY_OR_OTHER|||||||0.81|||||||Chi-squared|||Analysis for \< 34 weeks||||0.81
71683068|NCT00388297|142884209|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||Analysis for \<34 weeks||||0.47
71683069|NCT00388297|142884209|SUPERIORITY_OR_OTHER|||||||0.44|||||||Chi-squared|||Analysis for \<37 weeks||||0.44
71683070|NCT00388297|142884209|SUPERIORITY_OR_OTHER|||||||0.11|||||||Chi-squared|||Analysis for \< 37 weeks||||0.11
71913299|NCT01235507|143347150|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71913300|NCT01235507|143347150|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71913301|NCT01235507|143347151|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71913302|NCT01235507|143347151|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71913303|NCT01235507|143347151|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71869545|NCT01850446|143256374|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.05||||0.036|ONE_SIDED|97.5||0.19|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day1)||0.19||0.036
71869546|NCT01850446|143256374|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.01||||0.009|ONE_SIDED|97.5||0.15|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day2)||0.15||0.009
71869547|NCT01850446|143256374|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.03|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day3)||0.13||<0.001
71869548|NCT01850446|143256374|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day4)||0.13||<0.001
71869549|NCT01850446|143256374|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|ONE_SIDED|97.5||0.01|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day5)||0.01||<0.001
71869550|NCT01850446|143256375|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.0|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Percentage of Patients Requiring Antibiotics Administration||0.03||<0.001
71869551|NCT01850446|143256376|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.01||||0.014|ONE_SIDED|97.5||0.15|||Z test for proportions|||Proportion difference of Patients With Negative Results (day3)||0.15||0.014
71869552|NCT01850446|143256376|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.08||||0.037|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day5)||0.03||0.037
71869553|NCT01850446|143256376|NON_INFERIORITY|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.03|||<|0.001|ONE_SIDED|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day7)||0.03||<0.001
71869554|NCT01850446|143256377|SUPERIORITY||Mean Difference (Final Values)|1.89||||0.03|TWO_SIDED|95.0|0.19|3.59||P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-2)||3.59|0.19|0.03
71869555|NCT01850446|143256377|SUPERIORITY||Mean Difference (Final Values)|1.23||||0.19|TWO_SIDED|95.0|-0.64|3.12||P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-2)||3.12|-0.64|0.19
71869556|NCT01850446|143256377|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IFN-γ)||||0.012
71869557|NCT01850446|143256377|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IFN-γ)||||<0.0001
71683071|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.31|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (24 months)||3|0|0.31
71683072|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.3|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-II Language (24 months)||3|0|0.30
71869558|NCT01850446|143256377|SUPERIORITY|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-18)||||0.795
71869559|NCT01850446|143256377|SUPERIORITY|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-18)||||0.992
71869560|NCT01850446|143256377|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.04|TWO_SIDED|95.0|0.02|0.92|||t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-4)||0.92|0.02|0.04
71869561|NCT01850446|143256377|SUPERIORITY||Median Difference (Final Values)|0.37||||0.08|TWO_SIDED|95.0|-0.04|0.79|||t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-4)||0.79|-0.04|0.08
71869562|NCT01850446|143256377|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-16)||||0.062
71869563|NCT01850446|143256377|SUPERIORITY|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-16)||||0.638
71869564|NCT01850446|143256378|SUPERIORITY|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.065
71869565|NCT01850446|143256378|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)||||0.404
71869566|NCT01850446|143256378|SUPERIORITY|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-α)||||0.204
71869567|NCT01850446|143256378|SUPERIORITY|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-α)||||0.386
71683073|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (12 months)||0|0|0.89
71683074|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.54|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (12 months)||3|0|0.54
71683075|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.92|TWO_SIDED|95.0|-3.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|-3|0.92
71683076|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.7|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.70
71683077|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.2|TWO_SIDED|95.0|-3.0|0.0|||Chi-squared|||Bayley-III Motor (24 months)||0|-3|0.20
71913304|NCT01235507|143347152|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71913305|NCT01235507|143347152|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71913306|NCT01235507|143347152|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71683078|NCT00388297|142884209|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.71|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||Bayley-II Language (24 months)||2|-3|0.71
71683079|NCT00388297|142884210|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.89|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.89
71683080|NCT00388297|142884210|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.48|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.48
71683081|NCT00388297|142884211|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.9|TWO_SIDED|95.0|-2.0|3.0|||Chi-squared|||||3|-2|0.90
71683082|NCT00388297|142884211|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.64|TWO_SIDED|95.0|-3.0|2.0|||Chi-squared|||||2|-3|0.64
71683083|NCT00388297|142884212|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.6|TWO_SIDED|95.0|-5.0|7.0|||Chi-squared|||Analysis for recall of digits forward||7|-5|0.60
71683084|NCT00388297|142884212|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.22|TWO_SIDED|95.0|-8.0|0.0|||Chi-squared|||Analysis for recall of digits forward||0|-8|0.22
71683085|NCT00388297|142884212|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.52|TWO_SIDED|95.0|-6.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-6|0.52
71683086|NCT00388297|142884212|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.91|TWO_SIDED|95.0|-4.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures||0|-4|0.91
71683087|NCT00388297|142884213|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.63|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley II Cognitive (12 months)||0|0|0.63
71683088|NCT00388297|142884213|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.83|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley II Motor (12 mo)||3|0|0.83
71683089|NCT00388297|142884213|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.48|TWO_SIDED|95.0|0.0|3.0|||Chi-squared|||Bayley-III Language (12 months)||3|0|0.48
71683090|NCT00388297|142884213|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.59|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)||0|0|0.59
71683091|NCT00388297|142884214|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.99|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.99
71683092|NCT00388297|142884214|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.96|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 60 months||2|-2|0.96
71683093|NCT00388297|142884214|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.65|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months||2|-2|0.65
71683094|NCT00388297|142884214|SUPERIORITY_OR_OTHER||Hodges-Lehmann|-1.0||||0.44|TWO_SIDED|95.0|-3.0|1.0|||Chi-squared|||CBCL at 60 months||1|-3|0.44
71683095|NCT00388297|142884215|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.37|TWO_SIDED|95.0|-1.0|2.0|||Chi-squared|||||2|-1|0.37
71683096|NCT00388297|142884215|SUPERIORITY_OR_OTHER||Hodges-Lehmann|0.0||||0.98|TWO_SIDED|95.0|-2.0|2.0|||Chi-squared|||||2|-2|0.98
71913307|NCT01235507|143347153|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71913308|NCT01235507|143347153|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71683097|NCT00388297|142884216|SUPERIORITY_OR_OTHER|||||||0.12|||||||Chi-squared|||||||0.12
71683098|NCT00388297|142884216|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
71683099|NCT00388297|142884217|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||||||0.69
71683100|NCT00388297|142884217|SUPERIORITY_OR_OTHER|||||||0.51|||||||Chi-squared|||||||0.51
71683101|NCT00388297|142884218|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||||||0.76
71683102|NCT00388297|142884218|SUPERIORITY_OR_OTHER|||||||0.64|||||||Chi-squared|||||||0.64
71683103|NCT00388297|142884219|SUPERIORITY_OR_OTHER|||||||0.66|||||||Chi-squared|||||||0.66
71683104|NCT00388297|142884219|SUPERIORITY_OR_OTHER|||||||0.62|||||||Chi-squared|||||||0.62
71683105|NCT00388297|142884220|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
71683106|NCT00388297|142884220|SUPERIORITY_OR_OTHER|||||||0.55|||||||Chi-squared|||||||0.55
71683107|NCT00388297|142884221|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
71683108|NCT00388297|142884221|SUPERIORITY_OR_OTHER|||||||0.28|||||||Chi-squared|||||||0.28
71683109|NCT00388297|142884222|SUPERIORITY_OR_OTHER|||||||0.5|||||||Chi-squared|||||||0.50
71683110|NCT00388297|142884222|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
71683111|NCT00388297|142884223|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar at 1 min \< 4||||0.76
71683112|NCT00388297|142884223|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Apgar \> 4 at 1 minute||||0.76
71913309|NCT01235507|143347153|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71913310|NCT01235507|143347154|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 8||||<0.0005
71913311|NCT01235507|143347154|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 16||||<0.0005
71913312|NCT01235507|143347154|SUPERIORITY_OR_OTHER||||||<|0.0005|TWO_SIDED||||||Wilcoxon signed rank test|||Change from Baseline to Week 24||||<0.0005
71683113|NCT00388297|142884223|SUPERIORITY_OR_OTHER|||||||0.69|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.69
71683114|NCT00388297|142884223|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||Apgar \< 7 at 5 minutes||||0.45
71683115|NCT00388297|142884224|SUPERIORITY_OR_OTHER|||||||0.24|||||||Chi-squared|||||||0.24
71869568|NCT01850446|143256378|SUPERIORITY|||||||0.592|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-γ)||||0.592
71869569|NCT01850446|143256378|SUPERIORITY|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Spontaneous IFN-γ)||||0.356
71683116|NCT00388297|142884224|SUPERIORITY_OR_OTHER|||||||0.97|||||||Chi-squared|||||||0.97
71869570|NCT01850446|143256378|SUPERIORITY|||||||0.475|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-γ)||||0.475
71869571|NCT01850446|143256378|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-γ)||||>0.99
71869572|NCT01850446|143256379|SUPERIORITY|||||||0.364|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (leukocytes)||||0.364
71869573|NCT01850446|143256379|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (leukocytes)||||0.07
71869574|NCT01850446|143256379|SUPERIORITY|||||||0.607|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day1 to day 3 (neutrophils)||||0.607
71869575|NCT01850446|143256379|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (neutrophils)||||0.028
71869576|NCT01850446|143256379|SUPERIORITY|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (lymphocytes)||||0.759
71869577|NCT01850446|143256379|SUPERIORITY|||||||0.777|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.777
71869578|NCT01850446|143256379|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (monocytes)||||0.02
71683117|NCT00388297|142884225|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
71869579|NCT01850446|143256379|SUPERIORITY|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)||||0.343
71869580|NCT01850446|143256379|SUPERIORITY|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (eosinophils)||||0.575
71869581|NCT01850446|143256379|SUPERIORITY|||||||0.912|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (eosinophils)||||0.912
71869582|NCT01850446|143256379|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (basophils)||||0.242
71869583|NCT01850446|143256379|SUPERIORITY|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (basophils)||||0.102
71869584|NCT01850446|143256379|SUPERIORITY|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+)||||0.429
71869585|NCT01850446|143256379|SUPERIORITY|||||||0.783|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+)||||0.783
71869586|NCT01850446|143256379|SUPERIORITY|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD4+)||||0.466
71683118|NCT00388297|142884225|SUPERIORITY_OR_OTHER|||||||0.68|||||||Chi-squared|||||||0.68
71683119|NCT00388297|142884226|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||||||0.46
71683120|NCT00388297|142884226|SUPERIORITY_OR_OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71683121|NCT00388297|142884227|SUPERIORITY_OR_OTHER|||||||0.45|||||||Chi-squared|||||||0.45
71683122|NCT00388297|142884227|SUPERIORITY_OR_OTHER|||||||0.75|||||||Chi-squared|||||||0.75
71683123|NCT00388297|142884228|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71683124|NCT00388297|142884229|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71683125|NCT00388297|142884229|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71869587|NCT01850446|143256379|SUPERIORITY|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD4+)||||0.945
71913313|NCT01363258|143347157|OTHER|Generalized linear mixed models fitted with binomial (logit link) and gamma (log link) distributions, with additional dispersion parameters, were used to estimate and test intervention effects in terms of occurrence and intensity of CRBs, respectively. Inference was conducted in the link scale, but inverse-link estimates in the original scales (proportions and CRB scores, for the binomial and gamma models, respectively) were computed to facilitate interpretation.|Effect size|-0.16||||0.1433|TWO_SIDED||||||Time by group interaction test|||||||0.1433
71683126|NCT00388297|142884230|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||||||0.50
71683127|NCT00388297|142884230|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
71683128|NCT00388297|142884231|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||||||0.99
71683129|NCT00388297|142884231|SUPERIORITY_OR_OTHER|||||||0.85|||||||Chi-squared|||||||0.85
71683130|NCT00388297|142884232|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71683131|NCT00388297|142884232|SUPERIORITY_OR_OTHER|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71869588|NCT01850446|143256379|SUPERIORITY|||||||0.335|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD8+)||||0.335
71869589|NCT01850446|143256379|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD8+)||||0.66
71869590|NCT01850446|143256379|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD16+CD56+)||||0.01
71869591|NCT01850446|143256379|SUPERIORITY|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD16+CD56+)||||0.573
71869592|NCT01850446|143256379|SUPERIORITY|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD16+CD56+)||||0.472
71869593|NCT01850446|143256379|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD16+CD56+)||||0.69
71869594|NCT01850446|143256379|SUPERIORITY|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD8+)||||0.727
71869595|NCT01850446|143256379|SUPERIORITY|||||||0.554|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD8+)||||0.554
71869596|NCT01850446|143256379|SUPERIORITY|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD19+CD3-)||||0.837
71913314|NCT02754661|143347188|NON_INFERIORITY|The non-inferiority margin (δ) is pre-defined to be 5% in this study. Posterior Probability was based on Bayesian analysis.|Posterior Probability Bayesian analysis|0.9999|||||TWO_SIDED||||||||Support the claim of statistical non-inferiority of CCE vs CTC|||||
71869597|NCT01850446|143256379|SUPERIORITY|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD19+CD3-)||||0.967
71869598|NCT01850446|143256379|SUPERIORITY|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD119+)||||0.473
71869599|NCT01850446|143256379|SUPERIORITY|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD119+)||||0.736
71869600|NCT01850446|143256380|SUPERIORITY|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of neutrophils)||||0.282
71869601|NCT01850446|143256380|SUPERIORITY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of neutrophils)||||0.071
71869602|NCT01850446|143256380|SUPERIORITY|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of lymphocytes)||||0.45
71869603|NCT01850446|143256380|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of lymphocytes)||||0.58
71869604|NCT01850446|143256380|SUPERIORITY|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of monocytes)||||0.017
71869605|NCT01850446|143256380|SUPERIORITY|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of monocytes)||||0.019
71869606|NCT01850446|143256380|SUPERIORITY|||||||0.424|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of eosinophils)||||0.424
71869607|NCT01850446|143256380|SUPERIORITY|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of eosinophils)||||0.666
71869608|NCT01850446|143256380|SUPERIORITY|||||||0.268|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of basophils)||||0.268
71869609|NCT01850446|143256380|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of basophils)||||0.031
71869610|NCT01850446|143256380|SUPERIORITY|||||||0.361|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+)||||0.361
71869611|NCT01850446|143256380|SUPERIORITY|||||||0.699|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+)||||0.699
71869612|NCT01850446|143256380|SUPERIORITY|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD4+)||||0.418
71869613|NCT01850446|143256380|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD4+)||||>0.99
71869614|NCT01850446|143256380|SUPERIORITY|||||||0.172|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD8+)||||0.172
71869615|NCT01850446|143256380|SUPERIORITY|||||||0.904|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD8+)||||0.904
71869616|NCT01850446|143256380|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)||||0.148
71869617|NCT01850446|143256380|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)||||0.821
71869618|NCT01850446|143256380|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)||||0.31
71869619|NCT01850446|143256380|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)||||>0.99
71869620|NCT01850446|143256380|SUPERIORITY|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD8+)||||0.43
71869621|NCT01850446|143256380|SUPERIORITY|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD8+)||||0.821
71869622|NCT01850446|143256380|SUPERIORITY|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD19+CD3-)||||0.943
71869623|NCT01850446|143256380|SUPERIORITY|||||||0.841|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD19+CD3-)||||0.841
71869624|NCT00759915|143256399|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|109.98||||||90.0|100.1|120.8|||ANOVA|log-transformation||||120.8|100.1|
71869625|NCT00759915|143256401|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|100.91||||||90.0|96.96|105.0|||ANOVA|log-transformation||||105.0|96.96|
71869626|NCT00759915|143256402|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|96.5||||||90.0|92.3|100.97|||ANOVA|log-transformation||||100.97|92.3|
71869627|NCT03527173|143256411|NON_INFERIORITY|VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.|Vaccine efficacy rate|-9.4||||0.4266|TWO_SIDED|90.0|-96.7|33.7|||1-sided Barnard Unconditional Exact Test|||To demonstrate the efficacy of two vaccinations with 25 µg of S. sonnei vaccine in healthy adults compared to placebo in preventing shigellosis, fulfilling the protocol primary case definition, after challenge with S. sonnei 53G strain. Vaccine efficacy (VE) rate was assessed as 1-Risk Ratio(RR) with RR = ratio of proportion of subjects with shigellosis in the vaccinated group on the proportion of subjects with shigellosis in the placebo group.||33.7|-96.7|0.4266
71869628|NCT01248780|143256437|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71869629|NCT01248780|143256438|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71869630|NCT01248780|143256439|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71869631|NCT01248780|143256440|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71683132|NCT02607280|142884233|OTHER||LS mean change from baseline at Week 14|-1.79|||||TWO_SIDED|95.0|-2.45|-1.14||||||||-1.14|-2.45|
71913315|NCT02754661|143347189|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.3732|||<|0.0001|TWO_SIDED|90.0|0.203|0.5434|||Farrington-Manning test||Based on Farrington-Manning Method|||0.5434|0.2030|<0.0001
71913316|NCT02754661|143347190|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|-0.026||||0.019|TWO_SIDED|90.0|-0.0847|0.0327|||Farrington-Manning test||Based on Farrington-Manning Method|||0.0327|-0.0847|0.0190
71913317|NCT02754661|143347191|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0023||||0.093|TWO_SIDED|90.0|-0.1249|0.1249|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1249|-0.1249|0.0930
71913318|NCT02754661|143347192|NON_INFERIORITY|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0607||||0.0034|TWO_SIDED|90.0|-0.0371|0.1585|||Farrington-Manning test||Based on Farrington-Manning Method|||0.1585|-0.0371|0.0034
71913319|NCT04423757|143347193|OTHER||Adjusted mean difference|3.38|STANDARD_ERROR_OF_MEAN|3.1||0.2796|TWO_SIDED|90.0|-1.81|8.56|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.56|-1.81|0.2796
71913320|NCT04423757|143347194|OTHER||Odds Ratio (OR)|0.276||||0.0468|TWO_SIDED|90.0|0.091|0.781|||Regression, Logistic||For the calculation of the odds ratio Placebo is taken as reference.|Logistic regression includes treatment as covariate.||0.781|0.091|0.0468
71913321|NCT04423757|143347195|OTHER||Adjusted mean difference|1.35|STANDARD_ERROR_OF_MEAN|3.5||0.698|TWO_SIDED|90.0|-4.47|7.17|||Mixed Models Analysis||Difference calculated as BI - Placebo.|S-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||7.17|-4.47|0.6980
71913322|NCT04423757|143347195|OTHER||Adjusted mean difference|3.54|STANDARD_ERROR_OF_MEAN|3.1||0.2589|TWO_SIDED|90.0|-1.67|8.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|T-Anxiety scale - Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||8.76|-1.67|0.2589
71913323|NCT04423757|143347196|OTHER||Adjusted mean difference|0.51|STANDARD_ERROR_OF_MEAN|0.4||0.1863|TWO_SIDED|90.0|-0.13|1.15|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||1.15|-0.13|0.1863
71913324|NCT04423757|143347197|OTHER||Adjusted mean difference|0.65|STANDARD_ERROR_OF_MEAN|3.1||0.8326|TWO_SIDED|90.0|-4.46|5.76|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||5.76|-4.46|0.8326
71913325|NCT04423757|143347198|OTHER||Adjusted mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.4||0.5567|TWO_SIDED|90.0|-0.43|0.89|||Mixed Models Analysis||Difference calculated as BI - Placebo.|Mixed effects model for repeated measures (MMRM) with fixed effects of treatment, visit, treatment by visit interaction, baseline, and baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within-patient errors and Kenward-Roger approximation for denominator degrees of freedom.||0.89|-0.43|0.5567
71683133|NCT02607280|142884233|OTHER||LS mean change from baseline at Week 14|-2.07|||||TWO_SIDED|95.0|-3.77|-0.36||||||||-0.36|-3.77|
71913326|NCT02709109|143347201|SUPERIORITY||Least Square (LS) mean difference|0.2||||0.8173|TWO_SIDED|95.0|-1.4|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-1.4|0.8173
71913327|NCT02709109|143347201|SUPERIORITY||LS mean difference|-0.7||||0.5903|TWO_SIDED|95.0|-3.3|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.3|0.5903
71913328|NCT02709109|143347201|SUPERIORITY||LS mean difference|-0.7||||0.5917|TWO_SIDED|95.0|-3.4|1.9|||Mixed-effects Model for Repeated Measure|||||1.9|-3.4|0.5917
71913329|NCT02709109|143347201|SUPERIORITY||LS mean difference|-0.9||||0.5021|TWO_SIDED|95.0|-3.6|1.8|||Mixed-effects Model for Repeated Measure|||||1.8|-3.6|0.5021
71913330|NCT02709109|143347201|SUPERIORITY||LS mean difference|-1.6||||0.1382|TWO_SIDED|95.0|-3.8|0.5|||Mixed-effects Model for Repeated Measure|||||0.5|-3.8|0.1382
71913331|NCT02709109|143347201|SUPERIORITY||LS mean difference|0.9||||0.4962|TWO_SIDED|95.0|-1.7|3.5|||Mixed-effects Model for Repeated Measure|||||3.5|-1.7|0.4962
71913332|NCT05563714|143347204|SUPERIORITY||Odds Ratio (OR)|5.22|||<|0.001|TWO_SIDED|95.0|2.41|11.33|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Includes clinician proceduralist vs non-proceduralist status as a co-variate.||11.33|2.41|<0.001
71913333|NCT05563714|143347204|SUPERIORITY||Odds Ratio (OR)|5.76|||<|0.001|TWO_SIDED|95.0|2.54|13.05|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||13.05|2.54|<0.001
71683134|NCT00577005|142884234|SUPERIORITY_OR_OTHER||Slope|-0.05425|STANDARD_ERROR_OF_MEAN|0.03211||0.09|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly cocaine urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z=-1.68950 p = 0.09112|||||0.09
71913334|NCT05563714|143347205|SUPERIORITY||Odds Ratio (OR)|29.3|||<|0.001|TWO_SIDED|95.0|6.07|141.49|||generalized linear mixed effects model||Adjusted OR (base model)|Adjusted OR (base model), 95% CI - Included clinician proceduralist vs non-proceduralist status as a co-variate.||141.49|6.07|<0.001
71913335|NCT05563714|143347205|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|6.56|289.88|||generalized linear mixed effects model||Adjusted OR (expanded model)|Adjusted OR (expanded model), 95% CI - Adjusted for clinician proceduralist vs non-proceduralist status, patient age, sex, race, ethnicity, number of comorbidities, antiplatelet therapy used at baseline, and baseline use of H2 receptor antagonists.||289.88|6.56|<0.001
71913336|NCT05563714|143347206|SUPERIORITY|Adjusted OR, 95% CI (base model) - Included clinician proceduralist vs non-proceduralist status as a co-variate.|Odds Ratio, log|19.86|||<|0.001|TWO_SIDED|95.0|10.63|29.09|||generalized linear mixed effects model|||We used generalized linear mixed effects modeling (logit link) to estimate the odds of medication optimization at week 7-10. This model included fixed effects for CNNF (vs. usual care), target provider specialty and size, and a random effect for clinician to account for the clustering of patients. We report the log odds ratios with corresponding confidence intervals for the main effect. The main effect was tested at a two-sided 5% significance level.||29.09|10.63|<0.001
71913337|NCT01815580|143347213|OTHER||||||>|0.75|||||||Chi-squared|||||||>0.75
71913338|NCT01815580|143347214|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
71913339|NCT01815580|143347215|OTHER||||||>|0.3|||||||Chi-squared|||||||>0.3
71913340|NCT01815580|143347216|OTHER||||||>|0.12|||||||Chi-squared|||||||>0.12
71913341|NCT01815580|143347217|OTHER||||||>|0.22|||||||Chi-squared|||||||>0.22
71913342|NCT02228564|143347218|NON_INFERIORITY|"The sample size calculation assumes the following:~The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154."|||||<|0.0325|||||||Exact binomial test|||"H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%.~H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%."||||<0.0325
71913343|NCT01711658|143347238|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.3436|TWO_SIDED|95.0|0.56|1.46|||Log Rank|One-sided significance level = 0.1803|Reference level = IMRT + cisplatin + placebo|Hazard ratio (lapatinib/placebo) set at 0.65 (35% reduction), 1-sided alpha 0.20 (final test at 0.1803 accounting for 1 interim analysis), logrank test, 80% power, 69 events in 128 randomized (142 total enrolled) patients required. Final analysis at 67 (of 69) events drops power to 79%.||1.46|0.56|0.3436
71913344|NCT01711658|143347239|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.5836|TWO_SIDED|95.0|0.61|1.86|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.86|0.61|0.5836
71913345|NCT01711658|143347240|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.1743|TWO_SIDED|95.0|0.25|1.65|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||1.65|0.25|0.1743
71913346|NCT01711658|143347241|SUPERIORITY|||||||0.7989|||||||Fisher Exact|Two-sided significance level = 0.05||||||0.7989
71913347|NCT01711658|143347242|SUPERIORITY|||||||0.3728||||||IMRT|Fisher Exact|Two-sided significance level = 0.05||||||0.3728
71913348|NCT01711658|143347242|OTHER|||||||0.7781||||||Cisplatin|Fisher Exact|Two-sided significance level = 0.05||||||0.7781
71913349|NCT01711658|143347242|OTHER|||||||0.8||||||Pre-IMRT lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.8000
71913350|NCT01711658|143347242|OTHER|||||||0.6459||||||Concurrent lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.6459
71913351|NCT01711658|143347242|OTHER|||||||0.4792||||||Maintenance lapatinib/placebo|Fisher Exact|Two-sided significance level = 0.05||||||0.4792
71913352|NCT01711658|143347243|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6735|TWO_SIDED|95.0|0.62|2.17|||Log Rank|One-sided significance level = 0.05|Reference level = IMRT + cisplatin + placebo|||2.17|0.62|0.6735
71913353|NCT00418717|143347279|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||||95.0|-0.25|0.06||||||||0.06|-0.25|
71683135|NCT00577005|142884235|SUPERIORITY_OR_OTHER||Slope|0.0257|STANDARD_ERROR_OF_MEAN|0.04369||0.55|TWO_SIDED|||||p-value \<0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly opioid urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z= 0.58823 p = 0.55638|||||0.55
71683136|NCT00577005|142884236|SUPERIORITY_OR_OTHER|||||||0.67||||||p-value \<0.05 considered statistically significant|Log Rank|Chi-Square 0.175. df = 1, p=0.676||||||0.67
71683137|NCT00577005|142884237|SUPERIORITY_OR_OTHER||Slope|-0.1557||||0.11|TWO_SIDED|||||Significant p-value \< 0.05|Mixed Models Analysis||Interaction of time x group: Z = -1.5671, p = 0.11708|||||0.11
71683138|NCT01004432|142884238|SUPERIORITY_OR_OTHER||Percentage achive ACR 20 response|34.9|||<|0.0001|TWO_SIDED|95.0|30.4|39.4||One sided test adjusting for conducting one interim analysis|Chi-squared|||null hypothesis: proportion \<=0.2||39.4|30.4|<0.0001
71683139|NCT02696434|142884282|SUPERIORITY||Odds Ratio (OR)|0.68||||0.407|TWO_SIDED|95.0|0.28|1.68|||Regression, Logistic|||||1.68|0.28|0.407
71913354|NCT00249795|143347290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.992||||0.857|TWO_SIDED|95.0|0.907|1.085||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 4.5% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.085|0.907|0.8570
71913355|NCT00249795|143347291|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.12|TWO_SIDED|95.0|0.869|1.016||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 1% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.|||1.016|0.869|0.1200
71913356|NCT00249795|143347292|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.916||||0.2162|TWO_SIDED|95.0|0.796|1.053||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of a stroke in Irbesartan group versus Placebo group.|||1.053|0.796|0.2162
71913357|NCT00249795|143347293|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.014||||0.759|TWO_SIDED|95.0|0.927|1.11||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of death in Irbesartan group versus Placebo group.|||1.110|0.927|0.7590
71913358|NCT00249795|143347294|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.897||||0.0369|TWO_SIDED|95.0|0.809|0.993||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of HF episodes in Irbesartan group versus Placebo group.|||0.993|0.809|0.0369
71913359|NCT00249795|143347295|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.0175|TWO_SIDED|95.0|0.763|0.975||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for Heart Failure in Irbesartan group versus Placebo group.|||0.975|0.763|0.0175
71913360|NCT00249795|143347296|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.008||||0.8377|TWO_SIDED|95.0|0.93|1.093||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for other CV cause in Irbesartan group versus Placebo group.|||1.093|0.930|0.8377
71913361|NCT02460978|143347302|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.0579|<|0.0001|TWO_SIDED|95.0|-0.49|-0.26|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.26|-0.49|<0.0001
71913362|NCT02460978|143347302|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0578|<|0.0001|TWO_SIDED|95.0|-0.53|-0.3|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week\*treatment, and week\*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline||-0.30|-0.53|<0.0001
71913363|NCT02460978|143347303|SUPERIORITY||Mean Difference (Final Values)|-10.78|STANDARD_ERROR_OF_MEAN|1.5291|<|0.0001|TWO_SIDED|95.0|-13.73|-7.72|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-7.72|-13.73|<0.0001
71913364|NCT02460978|143347303|SUPERIORITY||Mean Difference (Final Values)|-11.08|STANDARD_ERROR_OF_MEAN|1.5331|<|0.0001|TWO_SIDED|95.0|-14.04|-8.02|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-8.02|-14.04|<0.0001
71913365|NCT02460978|143347304|SUPERIORITY||Mean Difference (Final Values)|-3.21|STANDARD_ERROR_OF_MEAN|0.3829|<|0.0001|TWO_SIDED|95.0|-3.96|-2.45|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.45|-3.96|<0.0001
71913366|NCT02460978|143347304|SUPERIORITY||Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|0.3812|<|0.0001|TWO_SIDED|95.0|-4.49|-2.99|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week\*treatment, and week\*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline||-2.99|-4.49|<0.0001
71913367|NCT02460978|143347305|SUPERIORITY||Mean Difference (Final Values)|-15.66|STANDARD_ERROR_OF_MEAN|2.3468|<|0.0001|TWO_SIDED|95.0|-20.26|-11.05|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-11.05|-20.26|<0.0001
71913368|NCT02460978|143347305|SUPERIORITY||Mean Difference (Final Values)|-19.74|STANDARD_ERROR_OF_MEAN|2.3419|<|0.0001|TWO_SIDED|95.0|-24.34|-15.14|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-15.14|-24.34|<0.0001
71913369|NCT02460978|143347306|SUPERIORITY||Mean Difference (Final Values)|-9.85|STANDARD_ERROR_OF_MEAN|2.4519|<|0.0001|TWO_SIDED|95.0|-14.66|-5.03|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-5.03|-14.66|<0.0001
71913370|NCT02460978|143347306|SUPERIORITY||Mean Difference (Final Values)|-9.36|STANDARD_ERROR_OF_MEAN|2.4487||0.0001|TWO_SIDED|95.0|-14.16|-4.55|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||-4.55|-14.16|0.0001
71913371|NCT02460978|143347307|SUPERIORITY||Mean Difference (Final Values)|9.02|STANDARD_ERROR_OF_MEAN|1.0415|<|0.0001|TWO_SIDED|95.0|6.97|11.06|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||11.06|6.97|<0.0001
71913372|NCT02460978|143347307|SUPERIORITY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|1.0396|<|0.0001|TWO_SIDED|95.0|8.66|12.74|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week\*treatment, and week\*baseline.||Difference vs. placebo in adjusted mean change from baseline||12.74|8.66|<0.0001
71913373|NCT02460978|143347308|SUPERIORITY||Odds Ratio (OR)|2.71|STANDARD_ERROR_OF_MEAN|0.2058|<|0.0001|TWO_SIDED|95.0|1.81|4.06|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.06|1.81|<0.0001
71913374|NCT02460978|143347308|SUPERIORITY||Odds Ratio (OR)|3.07|STANDARD_ERROR_OF_MEAN|0.2054|<|0.0001|TWO_SIDED|95.0|2.05|4.6|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo||4.60|2.05|<0.0001
71913375|NCT03549429|143347315|SUPERIORITY||Percent difference|8.0||||0.03|TWO_SIDED|95.0|1.5|14.4|||McNemar|||We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.||14.4|1.5|0.03
71913376|NCT03549429|143347316|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.23|TWO_SIDED||||||t-test, 2 sided|paired||||||0.23
71913377|NCT03061812|143347329|SUPERIORITY||Hazard Ratio (HR)|1.46||||0.0051|TWO_SIDED|95.0|1.17|1.82|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.82|1.17|0.0051
71913378|NCT03061812|143347330|SUPERIORITY||Hazard Ratio (HR)|1.51|||<|0.0001|TWO_SIDED|95.0|1.22|1.87|||Log Rank|Two-sided p-value stratified by the randomization stratification factors.|Calculated using a Cox proportional hazards regression model, with treatment and randomization stratification factors as covariates.|||1.87|1.22|< 0.0001
71913379|NCT03061812|143347331|SUPERIORITY||LS Mean of Difference|-0.5|STANDARD_ERROR_OF_MEAN|2.62|||TWO_SIDED|95.0|-5.66|4.65||||||||4.65|-5.66|
71913380|NCT03061812|143347332|SUPERIORITY||Odds Ratio (OR)|0.68||||0.3352|TWO_SIDED|95.0|0.39|1.18|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.18|0.39|0.3352
71913381|NCT03061812|143347333|SUPERIORITY||Odds Ratio (OR)|0.73||||0.0358|TWO_SIDED|95.0|0.47|1.12|||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors.||||1.12|0.47|0.0358
71913382|NCT00878644|143347346|SUPERIORITY||Risk Difference (RD)|7.3||||0.14|TWO_SIDED|95.0|-1.5|16.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||16.1|-1.5|0.14
71913383|NCT00878644|143347347|SUPERIORITY||Risk Difference (RD)|9.1||||0.13|TWO_SIDED|95.0|-1.8|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (\<2 years, 2 to \<12 years, or \>=12 years)||||19.9|-1.8|0.13
71913384|NCT00878644|143347348|SUPERIORITY|||||||0.13|||||||Stratified Mann-Whitney Test|Test stratified by age category (\<2 years, 2 to \<12 years, or \>=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.|||0.13
71913385|NCT00878644|143347349|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."||||||0.81
71913386|NCT02371980|143347355|SUPERIORITY||Hazard Ratio (HR)|0.517||||0.006|TWO_SIDED|95.0|0.323|0.828||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.828|0.323|0.006
71913387|NCT02371980|143347355|SUPERIORITY||Hazard Ratio (HR)|0.476||||0.002|TWO_SIDED|95.0|0.296|0.767||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.767|0.296|0.002
71913388|NCT02371980|143347355|SUPERIORITY||Hazard Ratio (HR)|0.483||||0.003|TWO_SIDED|95.0|0.298|0.782||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.782|0.298|0.003
71683140|NCT02539134|142884293|SUPERIORITY_OR_OTHER||Slope|1.06||||0.757|TWO_SIDED|90.0|0.741|1.374|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90 percent (%) confidence interval (CI) for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.374|0.741|0.757
71683141|NCT02539134|142884293|SUPERIORITY_OR_OTHER||Slope|1.37||||0.042|TWO_SIDED|90.0|1.078|1.664|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.664|1.078|0.042
71913389|NCT02371980|143347356|SUPERIORITY||Least Squares Mean (LSM) Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.421|TWO_SIDED|95.0|-1.63|0.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.68|-1.63|0.421
71913390|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.589||0.037|TWO_SIDED|95.0|-2.39|-0.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||-0.08|-2.39|0.037
71913391|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.592||0.488|TWO_SIDED|95.0|-1.57|0.75|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.75|-1.57|0.488
71913392|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.43|STANDARD_ERROR_OF_MEAN|0.765||0.002|TWO_SIDED|95.0|-3.93|-0.93|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.93|-3.93|0.002
71913393|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.761|<|0.001|TWO_SIDED|95.0|-4.49|-1.51|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-1.51|-4.49|<0.001
71913394|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.775||0.001|TWO_SIDED|95.0|-4.02|-0.98|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.98|-4.02|0.001
71913395|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|0.924||0.001|TWO_SIDED|95.0|-4.76|-1.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.13|-4.76|0.001
71913396|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.919|<|0.001|TWO_SIDED|95.0|-5.64|-2.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-2.03|-5.64|<0.001
71913397|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|0.939||0.001|TWO_SIDED|95.0|-4.84|-1.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-1.16|-4.84|0.001
71913398|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.92|STANDARD_ERROR_OF_MEAN|0.938||0.002|TWO_SIDED|95.0|-4.76|-1.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.08|-4.76|0.002
71913399|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-4.51|STANDARD_ERROR_OF_MEAN|0.934|<|0.001|TWO_SIDED|95.0|-6.34|-2.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-2.68|-6.34|<0.001
71913400|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.64|STANDARD_ERROR_OF_MEAN|0.949|<|0.001|TWO_SIDED|95.0|-5.5|-1.78|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-1.78|-5.50|<0.001
71913401|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.957||0.033|TWO_SIDED|95.0|-3.92|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.16|-3.92|0.033
71913402|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.69|STANDARD_ERROR_OF_MEAN|0.952|<|0.001|TWO_SIDED|95.0|-5.55|-1.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-1.82|-5.55|<0.001
71913403|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.63|STANDARD_ERROR_OF_MEAN|0.967||0.007|TWO_SIDED|95.0|-4.52|-0.73|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.73|-4.52|0.007
71913404|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|0.912||0.004|TWO_SIDED|95.0|-4.4|-0.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.82|-4.40|0.004
71913405|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.906|<|0.001|TWO_SIDED|95.0|-5.86|-2.31|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-2.31|-5.86|<0.001
71913406|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.76|STANDARD_ERROR_OF_MEAN|0.921||0.003|TWO_SIDED|95.0|-4.57|-0.96|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.96|-4.57|0.003
71683142|NCT02539134|142884294|SUPERIORITY_OR_OTHER||Slope|1.2||||0.191|TWO_SIDED|90.0|0.946|1.45|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.450|0.946|0.191
71683143|NCT02539134|142884294|SUPERIORITY_OR_OTHER||Slope|1.37||||0.036|TWO_SIDED|90.0|1.089|1.657|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.657|1.089|0.036
71683144|NCT02539134|142884295|SUPERIORITY_OR_OTHER||Slope|1.19||||0.288|TWO_SIDED|90.0|0.89|1.489|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.||1.489|0.890|0.288
71913407|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-1.92|STANDARD_ERROR_OF_MEAN|1.008||0.057|TWO_SIDED|95.0|-3.89|0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.06|-3.89|0.057
71913408|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.997|<|0.001|TWO_SIDED|95.0|-5.46|-1.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-1.55|-5.46|<0.001
71913409|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|1.011||0.012|TWO_SIDED|95.0|-4.51|-0.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.55|-4.51|0.012
71913410|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.012||0.061|TWO_SIDED|95.0|-3.88|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.09|-3.88|0.061
71913411|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-2.36|STANDARD_ERROR_OF_MEAN|0.997||0.018|TWO_SIDED|95.0|-4.31|-0.4|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||-0.40|-4.31|0.018
71913412|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-1.88|STANDARD_ERROR_OF_MEAN|1.015||0.065|TWO_SIDED|95.0|-3.87|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.12|-3.87|0.065
71913413|NCT02371980|143347356|SUPERIORITY||MMRM Model|-3.09|STANDARD_ERROR_OF_MEAN|1.136||0.007|TWO_SIDED|95.0|-5.31|-0.86|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.86|-5.31|0.007
71913414|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.97|STANDARD_ERROR_OF_MEAN|1.122|<|0.001|TWO_SIDED|95.0|-6.16|-1.77|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.77|-6.16|<0.001
71913415|NCT02371980|143347356|SUPERIORITY||Least Squares Mean Difference|-3.58|STANDARD_ERROR_OF_MEAN|1.143||0.002|TWO_SIDED|95.0|-5.82|-1.34|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-1.34|-5.82|0.002
71913416|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.085||0.732|TWO_SIDED|95.0|-0.2|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.14|-0.20|0.732
71913417|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.273|TWO_SIDED|95.0|-0.26|0.07|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.07|-0.26|0.273
71913418|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.085||0.361|TWO_SIDED|95.0|-0.24|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2||0.09|-0.24|0.361
71913419|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.099||0.004|TWO_SIDED|95.0|-0.48|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.09|-0.48|0.004
71913420|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.099||0.002|TWO_SIDED|95.0|-0.5|-0.12|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.12|-0.50|0.002
71913421|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.1|<|0.001|TWO_SIDED|95.0|-0.55|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4||-0.16|-0.55|<0.001
71913422|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.121||0.014|TWO_SIDED|95.0|-0.54|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.06|-0.54|0.014
71913423|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.121||0.001|TWO_SIDED|95.0|-0.63|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.16|-0.63|0.001
71683145|NCT02539134|142884296|SUPERIORITY_OR_OTHER||Slope|1.36||||0.039|TWO_SIDED|90.0|1.08|1.642|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.||1.642|1.080|0.039
71913424|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.123||0.002|TWO_SIDED|95.0|-0.62|-0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8||-0.14|-0.62|0.002
71913425|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.122||0.025|TWO_SIDED|95.0|-0.51|-0.03|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.03|-0.51|0.025
71913426|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.122|<|0.001|TWO_SIDED|95.0|-0.74|-0.26|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.26|-0.74|<0.001
71913427|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.124||0.002|TWO_SIDED|95.0|-0.63|-0.15|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12||-0.15|-0.63|0.002
71913428|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.123||0.333|TWO_SIDED|95.0|-0.36|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||0.12|-0.36|0.333
71913429|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.122||0.002|TWO_SIDED|95.0|-0.61|-0.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.13|-0.61|0.002
71913430|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.124||0.023|TWO_SIDED|95.0|-0.53|-0.04|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16||-0.04|-0.53|0.023
71683146|NCT04526574|142884335|NON_INFERIORITY|Noninferiority (NI) for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|Geometric Mean Ratio (GMR)|0.74|||||TWO_SIDED|95.0|0.65|0.84||||||Serotype 1: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of least square (LS) means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.65|
71913431|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.121||0.092|TWO_SIDED|95.0|-0.44|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||0.03|-0.44|0.092
71913432|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.121|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.20|-0.67|<0.001
71913433|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.122||0.008|TWO_SIDED|95.0|-0.57|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20||-0.09|-0.57|0.008
71913434|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.248|TWO_SIDED|95.0|-0.42|0.11|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.11|-0.42|0.248
71913435|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.133||0.006|TWO_SIDED|95.0|-0.63|-0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||-0.10|-0.63|0.006
71683147|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.75|0.9||||||Serotype 3: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.75|
71683148|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.77|1.02||||||Serotype 4: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.02|0.77|
71869632|NCT01190514|143256461|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|95.56|||||TWO_SIDED|90.0|86.94|105.04|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.04|86.94|
71869633|NCT01190514|143256461|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|101.31|||||TWO_SIDED|90.0|97.17|105.64|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||105.64|97.17|
71869634|NCT01190514|143256461|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|108.76|||||TWO_SIDED|90.0|101.1|117.01|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||117.01|101.10|
71869635|NCT01190514|143256463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|95.1|||||TWO_SIDED|90.0|89.37|101.2|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||101.20|89.37|
71869636|NCT01190514|143256463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|101.3|||||TWO_SIDED|90.0|94.66|108.4|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg\*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||108.40|94.66|
71869637|NCT01190514|143256463|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|115.54|||||TWO_SIDED|90.0|108.59|122.94|||Mixed Models Analysis||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."||122.94|108.59|
71869638|NCT01171807|143256511|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71869639|NCT04101318|143256526|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.625|TWO_SIDED|95.0|-0.38|0.62||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.62|-0.38|0.625
71913436|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.135||0.087|TWO_SIDED|95.0|-0.5|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24||0.03|-0.50|0.087
71913437|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.131||0.362|TWO_SIDED|95.0|-0.38|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.38|0.362
71913438|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.129||0.251|TWO_SIDED|95.0|-0.4|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.10|-0.40|0.251
71683149|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.79|0.98||||||Serotype 5: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.79|
71683150|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.88||||||Serotype 6A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.88|0.65|
71683151|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.81|||||TWO_SIDED|95.0|0.71|0.94||||||Serotype 6B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.94|0.71|
71683152|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.83|0.99||||||Serotype 7F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.99|0.83|
71683153|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.8|||||TWO_SIDED|95.0|0.7|0.93||||||Serotype 8: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.93|0.70|
71683154|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.94|||||TWO_SIDED|95.0|0.82|1.07||||||Serotype 9V: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.07|0.82|
71913439|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.131||0.391|TWO_SIDED|95.0|-0.37|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28||0.14|-0.37|0.391
71913440|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.141||0.209|TWO_SIDED|95.0|-0.45|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||0.10|-0.45|0.209
71913441|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.139||0.018|TWO_SIDED|95.0|-0.6|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.06|-0.60|0.018
71913442|NCT02371980|143347357|SUPERIORITY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.141||0.009|TWO_SIDED|95.0|-0.65|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32||-0.09|-0.65|0.009
71913443|NCT02371980|143347359|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.002|TWO_SIDED|95.0|0.302|0.766||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo||0.766|0.302|0.002
71913444|NCT02371980|143347359|SUPERIORITY||Hazard Ratio (HR)|0.455|||<|0.001|TWO_SIDED|95.0|0.286|0.725||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo||0.725|0.286|<0.001
71913445|NCT02371980|143347359|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.002|TWO_SIDED|95.0|0.304|0.771||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo||0.771|0.304|0.002
71913446|NCT01731990|143347360|SUPERIORITY_OR_OTHER_LEGACY||Treatment effect for ratio to placebo|1.06||||0.284|TWO_SIDED|90.0|0.97|1.15|||Mixed Models Analysis|||||1.15|0.97|0.284
71913447|NCT01280812|143347364|SUPERIORITY||Median Difference (Net)|1100.0|STANDARD_DEVIATION|3000.0|||TWO_SIDED|95.0|||||Mixed Models Analysis|Two-sided P values less than .05 were considered statistically significant.||Intent to treat analysis||||
71913448|NCT02279160|143347415|SUPERIORITY||Multiple imputation|0.742||||0.022|TWO_SIDED|95.0|0.575|0.958|||ANCOVA|||||0.958|0.575|0.0220
71913449|NCT02279160|143347416|SUPERIORITY||Hodges-Lehmann estimate|0.0||||0.9002|TWO_SIDED|95.0|-28.0|30.0|||Stratified Wilcoxon|||||30.0|-28.0|0.9002
71869640|NCT04101318|143256527|SUPERIORITY||Odds Ratio (OR)|1.737||||0.036|TWO_SIDED|95.0|1.038|2.908||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for itching evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.908|1.038|0.036
71869641|NCT04101318|143256528|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.202|TWO_SIDED|95.0|-0.9|0.2||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|The mode had following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.20|-0.90|0.202
71869642|NCT04101318|143256529|SUPERIORITY||Odds Ratio (OR)|1.369||||0.267|TWO_SIDED|95.0|0.781|2.401||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for pain evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.401|0.781|0.267
71869643|NCT04101318|143256530|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.545|TWO_SIDED|95.0|-0.57|0.3||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.30|-0.57|0.545
71869644|NCT04101318|143256531|SUPERIORITY||Odds Ratio (OR)|1.316||||0.293|TWO_SIDED|95.0|0.783|2.211||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Proportional odds ratio model|Ordinal regression model for burning evaluated on a 5 point scale. Product and period are fixed effects and subject is a random effect.|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||2.211|0.783|0.293
71869645|NCT04101318|143256532|SUPERIORITY||Odds Ratio (OR)|0.82||||0.375|TWO_SIDED|95.0|0.53|1.27||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|There is no difference between the two arms.||1.27|0.53|0.375
71869646|NCT04101318|143256533|SUPERIORITY||Odds Ratio (OR)|0.83||||0.482|TWO_SIDED|95.0|0.49|1.4||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects|Odds ratio, marginal= Arm1/Arm2|Null hypothesis: There is no difference between the two arms.||1.40|0.49|0.482
71869647|NCT04101318|143256534|SUPERIORITY||Odds Ratio (OR)|0.7||||0.151|TWO_SIDED|95.0|0.43|1.14||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|generalized linear mixed repeated model with fixed effects||Null hypothesis: There is no difference between the two arms.|Odds ratio, marginal= Arm1/Arm2|1.14|0.43|0.151
71869648|NCT04101318|143256535|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.725|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.725
71869649|NCT04101318|143256536|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.721|TWO_SIDED|95.0|-0.39|0.56||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.56|-0.39|0.721
71869650|NCT04101318|143256537|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.753|TWO_SIDED|95.0|-0.38|0.28||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.28|-0.38|0.753
71869651|NCT04101318|143256538|SUPERIORITY||Mean Difference (Final Values)|1.37||||0.331|TWO_SIDED|95.0|-1.43|4.18||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||4.18|-1.43|0.331
71869652|NCT04101318|143256539|SUPERIORITY||Mean Difference (Final Values)|11.68||||0.239|TWO_SIDED|95.0|-7.98|31.34||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject and the interaction between product and subject were random effects.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||31.34|-7.98|0.239
71869653|NCT04101318|143256540|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.322|TWO_SIDED|95.0|-0.91|0.31||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.31|-0.91|0.322
71913450|NCT03805971|143347425|SUPERIORITY|||||||0.0003|||||||Fisher Exact|||"The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0003
71913451|NCT03805971|143347425|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
71869654|NCT04101318|143256541|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.343|TWO_SIDED|95.0|-0.44|0.15||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.15|-0.44|0.343
71913452|NCT03805971|143347425|SUPERIORITY|||||||0.0052|||||||Fisher Exact|||"The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."||||0.0052
71913453|NCT03805971|143347425|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group."||||<0.0001
71913454|NCT03012594|143347430|SUPERIORITY|||||||0.07|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.07
71913455|NCT02864706|143347480|SUPERIORITY|||||||0.0043|||||||ANCOVA|Incidence of CAV at 5-7 yrs was compared between groups using Cochran-Mantel-Haenszel test with stratification according to baseline distribution||||||0.0043
71913456|NCT02864706|143347481|SUPERIORITY|||||||0.037|||||||Cochran-Mantel-Haenszel|||||||0.037
71913457|NCT03097133|143347519|SUPERIORITY||Difference of Least Square Means|-3.9|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.6|-1.11|||ANCOVA|||||-1.11|-6.60|0.006
71913458|NCT04080752|143347543|SUPERIORITY||Least Square (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.897||0.2494|TWO_SIDED|80.0|-1.76|0.55|||Mixed Model for Repeated Measures (MMRM)|||||0.55|-1.76|0.2494
71913459|NCT00918346|143347593|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type 1 error rate of 5%.|Mean Difference (Final Values)|0.01||||0.96||95.0|-0.46|0.49|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4.|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.49|-0.46|0.96
71913460|NCT00918346|143347594|NON_INFERIORITY_OR_EQUIVALENCE|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type I error rate of 5%.|Median Difference (Final Values)|-0.05||||0.83||95.0|-0.52|0.42|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation||0.42|-0.52|0.83
71913461|NCT01641081|143347675|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2644|STANDARD_ERROR_OF_MEAN|0.0148|<|0.0001|TWO_SIDED|95.0|0.2353|0.2934|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2934|0.2353|<0.0001
71913462|NCT01641081|143347675|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2524|STANDARD_ERROR_OF_MEAN|0.0156|<|0.0001|TWO_SIDED|95.0|0.2218|0.283|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2830|0.2218|<0.0001
71913463|NCT01641081|143347675|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2242|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1941|0.2544|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2544|0.1941|<0.0001
71913464|NCT01641081|143347675|SUPERIORITY_OR_OTHER||Least squares mean difference|0.2174|STANDARD_ERROR_OF_MEAN|0.0146|<|0.0001|TWO_SIDED|95.0|0.1887|0.2461|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate||||0.2461|0.1887|<0.0001
71913465|NCT01095666|143347677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.0869|<|0.0001|TWO_SIDED|95.0|-0.76|-0.42||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.42|-0.76|<0.0001
71913466|NCT01095666|143347677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.0865|<|0.0001|TWO_SIDED|95.0|-0.79|-0.45||Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment.|ANCOVA|||||-0.45|-0.79|<0.0001
71913467|NCT01095666|143347678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.1|STANDARD_ERROR_OF_MEAN|3.299|<|0.0001|TWO_SIDED|95.0|-28.6|-15.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-15.6|-28.6|<0.0001
71913468|NCT01095666|143347678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.1|STANDARD_ERROR_OF_MEAN|3.271|<|0.0001|TWO_SIDED|95.0|-33.5|-20.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-20.7|-33.5|<0.0001
71913469|NCT01095666|143347679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.3|STANDARD_ERROR_OF_MEAN|5.8758|<|0.0001|TWO_SIDED|95.0|-53.84|-30.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-30.73|-53.84|<0.0001
71913470|NCT01095666|143347679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.1|STANDARD_ERROR_OF_MEAN|5.7921|<|0.0001|TWO_SIDED|95.0|-60.53|-37.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-37.74|-60.53|<0.0001
71913471|NCT01095666|143347680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.2765|<|0.0001|TWO_SIDED|95.0|-1.65|-0.56||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-0.56|-1.65|<0.0001
71913472|NCT01095666|143347680|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.82|STANDARD_ERROR_OF_MEAN|0.2747|<|0.0001|TWO_SIDED|95.0|-2.36|-1.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||-1.28|-2.36|<0.0001
71913473|NCT01095666|143347681|SUPERIORITY_OR_OTHER||Difference in percentage|15.4|STANDARD_ERROR_OF_MEAN|4.702||0.001|TWO_SIDED|95.0|6.2|24.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.7|6.2|0.0010
71683155|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.83|||||TWO_SIDED|95.0|0.71|0.96||||||Serotype 10A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.71|
71683156|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.71|||||TWO_SIDED|95.0|0.6|0.84||||||Serotype 11A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.84|0.60|
71683157|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.82|||||TWO_SIDED|95.0|0.69|0.97||||||Serotype 12F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.97|0.69|
71869655|NCT04101318|143256542|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.387|TWO_SIDED|95.0|-0.53|0.21||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.21|-0.53|0.387
71869656|NCT04101318|143256543|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.899|TWO_SIDED|95.0|-0.18|0.16||The threshold for statistical significance was p=0.05. Furthermore, p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Model was with the following fixed effects: product and period. Subject was a random effect.|Difference between Arm 1 and Arm 2= Mean (Arm 1) - Mean (Arm 2)|Null hypothesis: There is no difference between the two arms.||0.16|-0.18|0.899
71869657|NCT00822172|143256554|SUPERIORITY|||||||0.076|||||||two-sample equal-variances t-test|||||||0.076
71869658|NCT00822172|143256555|SUPERIORITY|||||||0.048|||||||two-sample equal-variances t-test|||||||0.048
71869659|NCT00822172|143256556|SUPERIORITY|||||||0.65|||||||two-sample equal-variances t-test|||||||0.650
71869660|NCT01981473|143256561|SUPERIORITY_OR_OTHER||||||<|0.0001||||||As there was only one primary endpoint, no adjustment was made for multiple comparisons.|Fisher Exact|Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher's exact test was used.||This sample was to provide \>95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.||||<0.0001
71869661|NCT02257567|143256597|SUPERIORITY||Difference in Response Rates|5.82||||0.5353|TWO_SIDED|95.0|-14.53|25.38|||Cochran-Mantel-Haenszel|||||25.38|-14.53|0.5353
71869662|NCT02257567|143256597|SUPERIORITY||Difference in Response Rates (4.89|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
71869663|NCT02257567|143256606|SUPERIORITY||Difference in Response Rates|0.69||||0.8817|TWO_SIDED|95.0|-19.68|20.86|||Cochran-Mantel-Haenszel|||||20.86|-19.68|0.8817
71869664|NCT02257567|143256606|SUPERIORITY||Difference in Response Rates|27.5||||0.0061|TWO_SIDED|95.0|7.66|44.74|||Cochran-Mantel-Haenszel|||||44.74|7.66|0.0061
71869665|NCT02257567|143256608|SUPERIORITY||Difference in Response Rates|-1.0||||0.9523|TWO_SIDED|95.0|-18.66|16.46|||Cochran-Mantel-Haenszel|||||16.46|-18.66|0.9523
71869666|NCT02257567|143256608|SUPERIORITY||Difference in Response Rates|30.0||||0.0036|TWO_SIDED|95.0|9.48|47.37|||Cochran-Mantel-Haenszel|||||47.37|9.48|0.0036
71869667|NCT02257567|143256609|SUPERIORITY||Difference in Response Rates|3.75||||0.6574|TWO_SIDED|95.0|-15.14|22.11|||Cochran-Mantel-Haenszel|||||22.11|-15.14|0.6574
71869668|NCT02257567|143256609|SUPERIORITY||Difference in Response Rates|25.0||||0.0128|TWO_SIDED|95.0|4.89|42.63|||Cochran-Mantel-Haenszel|||||42.63|4.89|0.0128
71869669|NCT02257567|143256612|SUPERIORITY||Difference in Response Rates|3.88||||0.6225|TWO_SIDED|95.0|-14.49|21.72|||Cochran-Mantel-Haenszel|||||21.72|-14.49|0.6225
71869670|NCT02257567|143256612|SUPERIORITY||Difference in Response Rates|30.0||||0.0032|TWO_SIDED|95.0|9.94|47.12|||Cochran-Mantel-Haenszel|||||47.12|9.94|0.0032
71869671|NCT02257567|143256613|SUPERIORITY||Difference in Response Rates|-6.13||||0.4835|TWO_SIDED|95.0|-24.14|12.12|||Cochran-Mantel-Haenszel|||||12.12|-24.14|0.4835
71869672|NCT02257567|143256613|SUPERIORITY||Difference in Response Rates|25.0||||0.0096|TWO_SIDED|95.0|5.39|42.33|||Cochran-Mantel-Haenszel|||||42.33|5.39|0.0096
71869673|NCT02257567|143256614|SUPERIORITY||Difference in Response Rates|-0.5||||0.939|TWO_SIDED|95.0|-15.07|13.71|||Cochran-Mantel-Haenszel|||||13.71|-15.07|0.9390
71869674|NCT02257567|143256614|SUPERIORITY||Difference in Response Rates|37.5||||0.0006|TWO_SIDED|95.0|15.64|54.71|||Cochran-Mantel-Haenszel|||||54.71|15.64|0.0006
71869675|NCT02257567|143256615|SUPERIORITY||Difference in Response Rates|37.5||||0.0005|TWO_SIDED|95.0|15.82|54.62|||Cochran-Mantel-Haenszel|||||54.62|15.82|0.0005
71869676|NCT02257567|143256616|SUPERIORITY||Hazard Ratio (HR)|0.42||||0.0245|TWO_SIDED|95.0|0.19|0.91|||Log Rank|||||0.91|0.19|0.0245
71869677|NCT02257567|143256617|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.2451|TWO_SIDED|95.0|0.25|1.43|||Log Rank|||||1.43|0.25|0.2451
71869678|NCT02257567|143256618|SUPERIORITY||Hazard Ratio (HR)|0.33|||<|0.0001|TWO_SIDED|95.0|0.2|0.56|||Log Rank|||||0.56|0.20|<.0001
71869679|NCT02257567|143256619|SUPERIORITY||Hazard Ratio (HR)|0.39||||0.0003|TWO_SIDED|95.0|0.23|0.66|||Log Rank|||||0.66|0.23|0.0003
71913474|NCT01095666|143347681|SUPERIORITY_OR_OTHER||Difference in percentage|15.5|STANDARD_ERROR_OF_MEAN|4.594||0.0007|TWO_SIDED|95.0|6.5|24.5||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c||||24.5|6.5|0.0007
71913475|NCT03011775|143347690|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was P value of .05||||||<0.05
71913476|NCT03011775|143347691|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71913477|NCT03011775|143347693|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71913478|NCT03011775|143347694|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71913479|NCT03011775|143347696|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71913480|NCT03011775|143347697|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71913481|NCT03011775|143347698|SUPERIORITY||||||=|0.3|||||||Wilcoxon (Mann-Whitney)|||||||=0.3
71913482|NCT00588380|143347699|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Kruskal-Wallis|||Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was \<0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.||||0.11
71913483|NCT00588380|143347700|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Kruskal-Wallis|||All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal||||0.09
71913484|NCT01000025|143347707|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.506|TWO_SIDED|95.0|0.83|1.21||Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.|Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.||1.21|0.83|0.506
71913485|NCT01000025|143347708|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.043|TWO_SIDED|95.0|0.61|1.03||1-sided p-value|Log Rank|Stratified by stratification factors at randomization except study center.||||1.03|0.61|0.043
71913486|NCT01000025|143347709|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.98||||0.46|TWO_SIDED|95.0|0.67|1.44||1-sided pvalue|Log Rank|||||1.44|0.67|0.46
71913487|NCT01000025|143347710|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.55|0.79|||Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||||0.79|0.55|< 0.0001
71913488|NCT01000025|143347711|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.11||||0.001|TWO_SIDED|95.0|1.84|20.3|||Cochran-Mantel-Haenszel|||||20.3|1.84|0.001
71913489|NCT02738580|143347719|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|0.26|<|0.05|TWO_SIDED|||||The proportion of patients with elevated Progesterone on last day of stimulation(\>1.5 ng/mL) was compared between both groups using the Chi-square test.|t-test, 2 sided|||||||<0.05
71913490|NCT02738580|143347720|SUPERIORITY||||||<|0.49|||||||t-test, 1 sided|||||||<0.49
71913491|NCT01000818|143347721|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.39||||||95.0|1.04|1.84||||||||1.84|1.04|
71913492|NCT01000818|143347721|NON_INFERIORITY_OR_EQUIVALENCE|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.45||||||95.0|1.09|1.93||||||||1.93|1.09|
71913493|NCT00996593|143347722|SUPERIORITY_OR_OTHER||Percentage of participants|65.0|||||TWO_SIDED|95.0|50.0|80.0|||||The estimated value represents the percentage of participants with complete response.|||80|50|
71913494|NCT00996593|143347723|SUPERIORITY_OR_OTHER||Percentage of participants|23.0|||||TWO_SIDED|95.0|10.0|35.0|||||The estimated value represents the percentage of participants with complete response.|||35|10|
71913495|NCT00996593|143347724|SUPERIORITY_OR_OTHER||Percentage of participants|38.0|||||TWO_SIDED|95.0|22.0|53.0|||||The estimated value represents the percentage of participants with complete response.|||53|22|
71913496|NCT00996593|143347725|SUPERIORITY_OR_OTHER||Percentage of participants|28.0|||||TWO_SIDED|95.0|14.0|41.0|||||The estimated value represents the percentage of participants with complete response.|||41|14|
71913497|NCT00996593|143347730|SUPERIORITY_OR_OTHER||Percentage of responders|75.0||||1|TWO_SIDED|95.0|54.0|96.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||96|54|1.0
71913498|NCT00996593|143347730|SUPERIORITY_OR_OTHER||Percentage of responders|70.0||||1|TWO_SIDED|95.0|51.0|88.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||88|51|1.0
71913499|NCT00996593|143347731|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||Fisher Exact|||||||0.8
71913500|NCT00996593|143347732|SUPERIORITY_OR_OTHER||Percentage of responders|31.0||||1|TWO_SIDED|95.0|9.0|54.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||54|9|1.0
71913501|NCT00996593|143347732|SUPERIORITY_OR_OTHER||Percentage of responders|17.0||||1|TWO_SIDED|95.0|2.0|33.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.|||33|2|1.0
71913502|NCT00996593|143347733|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||||||0.2
71913503|NCT00996593|143347734|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Log Rank|||||||0.9
71869680|NCT01502631|143256681|SUPERIORITY||Least Squares (LS) Mean|5.61|STANDARD_ERROR_OF_MEAN|4.497||0.2182|TWO_SIDED|90.0|-1.93|13.14|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 2||13.14|-1.93|0.2182
71869681|NCT01502631|143256681|SUPERIORITY||Least Squares (LS) Mean|6.87|STANDARD_ERROR_OF_MEAN|5.583||0.226|TWO_SIDED|90.0|-2.54|16.27|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 4||16.27|-2.54|0.2260
71869682|NCT01502631|143256681|SUPERIORITY||Least Squares (LS) Mean|3.03|STANDARD_ERROR_OF_MEAN|6.023||0.6184|TWO_SIDED|90.0|-7.15|13.21|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 8||13.21|-7.15|0.6184
71869683|NCT01502631|143256681|SUPERIORITY||Least Squares (LS) Mean|4.54|STANDARD_ERROR_OF_MEAN|6.524||0.4912|TWO_SIDED|90.0|-6.48|15.56|||Mixed Model Repeated Measures (MMRM)|||Difference (SUN13837 - Placebo) at Week 16||15.56|-6.48|0.4912
71869684|NCT02084056|143256688|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.68|STANDARD_ERROR_OF_MEAN|1.018|<|0.0001|TWO_SIDED|90.0|100.703|106.747|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||106.747|100.703|<0.0001
71869685|NCT02084056|143256688|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.63|STANDARD_ERROR_OF_MEAN|1.047||0.0003|TWO_SIDED|90.0|93.721|110.202|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||110.202|93.721|0.0003
71869686|NCT02084056|143256689|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|114.58|STANDARD_ERROR_OF_MEAN|1.038||0.0113|TWO_SIDED|90.0|107.687|121.908|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||121.908|107.687|0.0113
71869687|NCT02084056|143256689|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.28|STANDARD_ERROR_OF_MEAN|1.075||0.0064|TWO_SIDED|90.0|86.543|111.609|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||111.609|86.543|0.0064
71869688|NCT02084056|143256690|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.45|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|91.23|101.97|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.97|91.23|<0.0001
71869689|NCT02084056|143256690|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.75|STANDARD_ERROR_OF_MEAN|1.04||0.0002|TWO_SIDED|90.0|90.47|105.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||105.63|90.47|0.0002
71869690|NCT02084056|143256691|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.96|STANDARD_ERROR_OF_MEAN|1.038|<|0.0001|TWO_SIDED|90.0|92.046|104.257|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||104.257|92.046|<0.0001
71869691|NCT02084056|143256691|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.85|STANDARD_ERROR_OF_MEAN|1.053||0.003|TWO_SIDED|90.0|96.705|115.861|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||115.861|96.705|0.0030
71869692|NCT02084056|143256692|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.48|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|90.0|98.426|108.79|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||108.790|98.426|<0.0001
71869693|NCT02084056|143256692|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.35|STANDARD_ERROR_OF_MEAN|1.062||0.0019|TWO_SIDED|90.0|91.13|112.708|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||112.708|91.130|0.0019
71869694|NCT02084056|143256693|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|95.49|STANDARD_ERROR_OF_MEAN|1.04|<|0.0001|TWO_SIDED|90.0|89.73|101.62|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)|||101.62|89.73|<0.0001
71869695|NCT02084056|143256693|NON_INFERIORITY_OR_EQUIVALENCE|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.19|STANDARD_ERROR_OF_MEAN|1.05||0.0002|TWO_SIDED|90.0|90.73|106.27|||ANOVA|ANOVA on the logarithmic scale including effects for 'sequence', 'subjects within sequences', 'period', and 'treatment'.|Ratio of (FDC 2000 fed/ L+M 2000 fed)|||106.27|90.73|0.0002
71869696|NCT00395460|143256734|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).|Mean Difference (Final Values)|6.939|STANDARD_DEVIATION|38.83|||ONE_SIDED|95.0|-3.897||||non-inferiority||||||-3.897|
71869697|NCT01856868|143256838|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
71869698|NCT01856868|143256839|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0185|||||||t-test, 2 sided|||||||0.0185
71869699|NCT01856868|143256840|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0434|||||||t-test, 2 sided|||||||0.0434
71869700|NCT01856868|143256841|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0078|||||||t-test, 2 sided|||||||0.0078
71869701|NCT01856868|143256842|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0025|||||||t-test, 2 sided|||||||0.0025
71869702|NCT01856868|143256843|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0082|||||||t-test, 2 sided|||||||0.0082
71869703|NCT01856868|143256844|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.031|||||||t-test, 2 sided|||||||0.031
71869704|NCT01856868|143256845|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0238|||||||Wilcoxon (Mann-Whitney)|||||||0.0238
71869705|NCT01856868|143256846|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0321|||||||t-test, 2 sided|||||||0.0321
71869706|NCT01856868|143256847|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0182|||||||t-test, 2 sided|||||||0.0182
71869707|NCT01856868|143256848|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0371|||||||t-test, 2 sided|||||||0.0371
71869708|NCT01856868|143256849|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a paired t-test analysis.||||||0.0257|||||||t-test, 2 sided|||||||0.0257
71869709|NCT01856868|143256852|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height and weight using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|-1.82|STANDARD_ERROR_OF_MEAN|2.51||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
71869710|NCT01856868|143256853|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|11.2|STANDARD_ERROR_OF_MEAN|16.6||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.50
71869711|NCT01856868|143256855|EQUIVALENCE|Difference in baseline and 8 week scores was evaluated using a mixed model regression analysis, including fixed effects for height, weight and knee extension strength using patient identity as source of random variation. As a pilot study, these measures were not subject to a formal power analysis but will be used in future sample size calculations.|Mean Difference (Net)|5.33|STANDARD_ERROR_OF_MEAN|3.79||0.159|TWO_SIDED||||||Mixed Models Analysis|||||||0.159
71869712|NCT00968227|143256856|SUPERIORITY|Paired t-test||||||0.001|||||||t-test, 2 sided|||||||0.001
71869713|NCT00190749|143256867|SUPERIORITY_OR_OTHER|||||||0.226||95.0||||P-value for change to last observation|t-test, 2 sided|||||||0.226
71869714|NCT00190749|143256867|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value is change to last observation|t-test, 2 sided|||||||0.030
71869715|NCT00190749|143256867|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||P-value for change to last observation.|ANCOVA|||||||0.204
71869716|NCT00190749|143256868|SUPERIORITY_OR_OTHER|||||||0.184||95.0|||||Pearson's correlation coefficient|||||||0.184
71869717|NCT00190749|143256868|SUPERIORITY_OR_OTHER|||||||0.295||95.0|||||Pearson's correlation coefficient|||||||0.295
71869718|NCT00190749|143256869|SUPERIORITY_OR_OTHER|||||||0.256||95.0|||||Pearson's correlation coefficient|||||||0.256
71869719|NCT00190749|143256869|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||Pearson's correlation coefficient|||||||0.277
71869720|NCT00190749|143256870|SUPERIORITY_OR_OTHER|||||||0.766||95.0|||||Pearson's correlation coefficient|||||||0.766
71869721|NCT00190749|143256870|SUPERIORITY_OR_OTHER|||||||0.622||95.0|||||Pearson's correlation coefficient|||||||0.622
71683158|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.86|||||TWO_SIDED|95.0|0.76|0.96||||||Serotype 14: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.96|0.76|
71869722|NCT00190749|143256871|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||Pearson's correlation coefficient|||||||0.829
71869723|NCT00190749|143256871|SUPERIORITY_OR_OTHER|||||||0.714||95.0|||||Pearson's correlation coefficient|||||||0.714
71869724|NCT00190749|143256872|SUPERIORITY_OR_OTHER|||||||0.672||95.0|||||Pearson's correlation coefficient|||||||0.672
71869725|NCT00190749|143256872|SUPERIORITY_OR_OTHER|||||||0.191||95.0|||||Pearson's correlation coefficient|||||||0.191
71869726|NCT00190749|143256873|SUPERIORITY_OR_OTHER|||||||0.994||95.0|||||Pearson's correlation coefficient|||||||0.994
71869727|NCT00190749|143256873|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||Pearson's correlation coefficient|||||||0.456
71869728|NCT00190749|143256874|SUPERIORITY_OR_OTHER|||||||0.454||95.0|||||Pearson's correlation coefficient|||||||0.454
71869729|NCT00190749|143256874|SUPERIORITY_OR_OTHER|||||||0.974||95.0|||||Pearson's correlation coefficient|||||||0.974
71913504|NCT00583661|143347797|NON_INFERIORITY_OR_EQUIVALENCE|Sample size determination: A sample of 24 subjects followed for approximately 100 days provides greater than 80% power to conclude that, with a 1-sided alpha=0.025 test, the SAE rate of the EXCOR (assumed to be 0.21 per patient-day) is less than 0.25 per patient-day. This sample size was estimated using 10,000 simulations of this study. A total enrollment of 48 subjects (24 per cohort) were enrolled and implanted with the EXCOR® Pediatric.|Poisson confidence interval|0.25|||<|0.05|TWO_SIDED|95.0|0.0|0.25||A Poisson exact confidence interval was calculated and the critical-value method was used for the significance testing. Success was defined as the upper bound of the 95% Poisson exact confidence interval being less than 0.25.|Poisson confidence interval|||Ho: EXCOR® SAE Rate \>=0.25 Ha: EXCOR® SAE Rate \< 0.25 Where serious adverse event (SAE) rate is calculated as the total number of serious adverse events divided by the sum of days all patients are on the EXCOR® Pediatric device, and 0.25 serious adverse events per patient-day is the success criterion. Study success in terms of safety will be demonstrated by the upper bound of a two-sided 95% Poisson exact confidence interval being less than 0.25.||0.25|0|<0.05
71913505|NCT04010370|143347800|SUPERIORITY||||||<|0.001|||||||Spearman correlation|||Correlation of McAuley index with PREDIM index at baseline.||||<0.001
71913506|NCT04010370|143347801|SUPERIORITY|||||||0.319|||||||Spearman correlation|||Correlation of Belfiore index with PREDIM index at baseline.||||0.319
71913507|NCT04010370|143347802|SUPERIORITY|||||||0.27|||||||Spearman correlation|||Correlation of Cederholm index with PREDIM index at baseline.||||0.27
71913508|NCT04010370|143347803|SUPERIORITY|||||||0.246|||||||Spearman correlation|||Correlation of Avignon index with PREDIM index at baseline.||||0.246
71913509|NCT04010370|143347804|SUPERIORITY|||||||0.259|||||||Spearman correlation|||Correlation of Matsuda index with PREDIM index at baseline.||||0.259
71869730|NCT00190749|143256875|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||Pearson's correlation coefficient|||||||0.249
71869731|NCT00190749|143256875|SUPERIORITY_OR_OTHER|||||||0.163||95.0|||||Pearson's correlation coefficient|||||||0.163
71869732|NCT00190749|143256876|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Pearson's correlation coefficient|||||||0.201
71869733|NCT00190749|143256876|SUPERIORITY_OR_OTHER|||||||0.168||95.0|||||Pearson's correlation coefficient|||||||0.168
71869734|NCT00190749|143256877|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||Pearson's correlation coefficient|||||||0.793
71869735|NCT00190749|143256877|SUPERIORITY_OR_OTHER|||||||0.777||95.0|||||Pearson's correlation coefficient|||||||0.777
71869736|NCT00190749|143256878|SUPERIORITY_OR_OTHER|||||||0.815||95.0|||||Pearson's correlation coefficient|||||||0.815
71869737|NCT00190749|143256878|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||||||0.675
71869738|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.393||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.393
71869739|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1||||0.033
71869740|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.392||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.392
71869741|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.129||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2||||0.129
71913510|NCT04010370|143347805|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of Gutt index with PREDIM index at baseline.||||0.69
71913511|NCT04010370|143347806|SUPERIORITY|||||||0.022|||||||Spearman correlation|||Correlation of Stumvoll index with PREDIM index at baseline.||||0.022
71913512|NCT04010370|143347807|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of HOMA-IR index with PREDIM index at baseline.||||0.69
71913513|NCT04010370|143347808|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of ISI index with PREDIM index at baseline.||||0.69
71913514|NCT04010370|143347809|SUPERIORITY|||||||0.541|||||||Spearman correlation|||Correlation of Raynaud index with PREDIM index at baseline.||||0.541
71913515|NCT04010370|143347810|SUPERIORITY|||||||0.69|||||||Spearman correlation|||Correlation of QUICKI index with PREDIM index at baseline.||||0.69
71913516|NCT04010370|143347811|SUPERIORITY|||||||0.531|||||||Spearman correlation|||Correlation of FIRI index with PREDIM index at baseline.||||0.531
71913517|NCT04010370|143347812|SUPERIORITY|||||||0.726|||||||Spearman correlation|||Correlation of Bennett index with PREDIM index at baseline.||||0.726
71913518|NCT04010370|143347813|SUPERIORITY|||||||0.787|||||||Spearman correlation|||Correlation of TyG index with PREDIM index at baseline.||||0.787
71869742|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.956||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 3||||0.956
71869743|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 3||||0.846
71869744|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.675||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.675
71869745|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.306||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4||||0.306
71869746|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.468||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.468
71869747|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.739||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5||||0.739
71869748|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.404||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.404
71869749|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.711||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6||||0.711
71869750|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.281
71869751|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.805||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7||||0.805
71869752|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.844||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 8||||0.844
71869753|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.359||95.0|||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 8||||0.359
71869754|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.642||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.642
71869755|NCT00190749|143256879|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9||||0.043
71869756|NCT00190749|143256880|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on Least Squares Mean (LSMean) change||||||<.001
71869757|NCT00190749|143256880|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.019
71869758|NCT00190749|143256880|SUPERIORITY_OR_OTHER|||||||0.065||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||||||0.065
71869759|NCT00190749|143256881|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||<.001
71869760|NCT00190749|143256881|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.013
71869761|NCT00190749|143256881|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.076
71869762|NCT00190749|143256882|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.007
71869763|NCT00190749|143256882|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.266
71869764|NCT00190749|143256882|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator||||||0.239
71869765|NCT00190749|143256883|SUPERIORITY_OR_OTHER|||||||0.274||95.0|||||t-test, 2 sided|Within group p-vales are from t-tests on LSMean change||||||0.274
71869766|NCT00190749|143256883|SUPERIORITY_OR_OTHER|||||||0.105||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change.||||||0.105
71869767|NCT00190749|143256883|SUPERIORITY_OR_OTHER|||||||0.609||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.609
71869768|NCT00190749|143256884|SUPERIORITY_OR_OTHER|||||||0.406||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||||||0.406
71869769|NCT00190749|143256884|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.011
71869770|NCT00190749|143256884|SUPERIORITY_OR_OTHER|||||||0.076||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.076
71869771|NCT00190749|143256885|SUPERIORITY_OR_OTHER|||||||0.456||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.456
71869772|NCT00190749|143256885|SUPERIORITY_OR_OTHER|||||||0.712||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.712
71869773|NCT00190749|143256885|SUPERIORITY_OR_OTHER|||||||0.689||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator||||||0.689
71869774|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean||Total Score||||0.111
71869775|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean changes||Total Score||||0.159
71869776|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.951||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Total Score||||0.951
71869777|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Positive Subscale||||0.012
71869778|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean||Positive subscale||||0.002
71869779|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.467||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Positive subscale||||0.467
71869780|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.365||95.0|||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||Negative subscale||||0.365
71869781|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.846||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Negative subscale||||0.846
71869782|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Negative subscale||||0.559
71869783|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.150
71869784|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.612||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale||||0.612
71869785|NCT00190749|143256886|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Anxiety-Depression subscale||||0.475
71869786|NCT00190749|143256887|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||Within group p-values are from t-tests on LSMean change|t-test, 2 sided|||||||.012
71869787|NCT00190749|143256887|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.010
71869788|NCT00190749|143256887|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.760
71869789|NCT00190749|143256888|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.943
71869790|NCT00190749|143256888|SUPERIORITY_OR_OTHER|||||||0.763||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.763
71869791|NCT00190749|143256888|SUPERIORITY_OR_OTHER|||||||0.832||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.832
71869792|NCT00190749|143256889|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.623
71869793|NCT00190749|143256889|SUPERIORITY_OR_OTHER|||||||0.853||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.853
71869794|NCT00190749|143256889|SUPERIORITY_OR_OTHER|||||||0.591||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.591
71869795|NCT00190749|143256890|SUPERIORITY_OR_OTHER|||||||0.302||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.302
71869796|NCT00190749|143256890|SUPERIORITY_OR_OTHER|||||||0.922||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.922
71869797|NCT00190749|143256890|SUPERIORITY_OR_OTHER|||||||0.479||95.0|||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.479
71869798|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.004
71869799|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1||||0.001
71869800|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 1||||0.549
71869801|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.011
71869802|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2||||0.009
71869803|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 2||||0.793
71869804|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.045
71869805|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3||||0.027
71869806|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.699||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 3||||0.699
71869807|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 4||||0.002
71869808|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||ITem 4||||0.019
71869809|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 4||||0.733
71913519|NCT01324687|143347814|SUPERIORITY_OR_OTHER||Rate ratio|0.8387||||0.017|TWO_SIDED|95.0|0.7261|0.9689|||GEE / Poisson regression models|||Rate ratio of ED use rate of the intervention group as compared to the control group.||0.9689|0.7261|0.017
71869810|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.034
71869811|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.235||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5||||0.235
71869812|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.532||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 5||||0.532
71869813|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.242||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.242
71869814|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6||||0.186
71869815|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.799||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 6||||0.799
71869816|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.097
71869817|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7||||0.214
71869818|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.827||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 7||||0.827
71869819|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.151||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.151
71869820|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8||||0.071
71869821|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.629||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 8||||0.629
71869822|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.036
71869823|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9||||0.112
71869824|NCT00190749|143256891|SUPERIORITY_OR_OTHER|||||||0.806||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 9||||0.806
71869825|NCT00190749|143256892|SUPERIORITY_OR_OTHER|||||||0.156||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.156
71869826|NCT00190749|143256892|SUPERIORITY_OR_OTHER|||||||0.829||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.829
71869827|NCT00190749|143256892|SUPERIORITY_OR_OTHER|||||||0.352||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.352
71869828|NCT00190749|143256893|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.740
71869829|NCT00190749|143256893|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||t-test, 2 sided|Within group p-values are frm t-tests on LSMean change||||||0.760
71869830|NCT00190749|143256893|SUPERIORITY_OR_OTHER|||||||0.997||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.997
71869831|NCT00190749|143256894|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.176
71869832|NCT00190749|143256894|SUPERIORITY_OR_OTHER|||||||0.237||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.237
71869833|NCT00190749|143256894|SUPERIORITY_OR_OTHER|||||||0.996||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.996
71869834|NCT00190749|143256895|SUPERIORITY_OR_OTHER|||||||0.027||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.027
71869835|NCT00190749|143256895|SUPERIORITY_OR_OTHER|||||||0.545||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||||||0.545
71869836|NCT00190749|143256895|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||||||0.024
71869837|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.009
71869838|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.959||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total||||0.959
71869839|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator|ANCOVA|||HDL particles, total||||0.038
71869840|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.013
71869841|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.928||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL||||0.928
71913520|NCT01610206|143347825|EQUIVALENCE|To estimate the progression-free survival hazard ratio of the combination of weekly gemcitabine and pazopanib compared to weekly gemcitabine alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.|Hazard Ratio (HR)|0.81||||0.019|TWO_SIDED|95.0|0.61|1.07|||non-parametric weighted Tarone-Ware test|||||1.07|0.61|0.019
71913521|NCT00166517|143347827|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was assessed versus a constant, 85%, based on historical data.||||||0.003||95.0||||p ≥.85, where p is the proportion of subjects who achieved ≥3-fold rise from baseline in the group that received RotaTeq®|Exact test of proportion|Exact test of proportion, based on binomial distribution||||||0.003
71913522|NCT00937326|143347898|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.25 g/day in number of participants with any AE.||||0.4816
71913523|NCT00937326|143347898|SUPERIORITY|||||||0.1147||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.5 g/day in number of participants with any AE.||||0.1147
71869842|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||IDL||||0.049
71869843|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.009
71869844|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.662||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL||||0.662
71869845|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Medium small LDL||||0.12
71869846|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.099||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.099
71869847|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.304||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL||||0.304
71869848|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Small LDL||||0.024
71869849|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.176||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Very small LDL||||0.176
71913524|NCT00937326|143347898|SUPERIORITY|||||||1||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 1.0 g/day in number of participants with any AE.||||1.0000
71913525|NCT00937326|143347898|SUPERIORITY|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 2.0 g/day in number of participants with any AE.||||0.4816
71913526|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|168.4|||||TWO_SIDED|90.0|123.87|228.94|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.||228.94|123.87|
71913527|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|110.88|||||TWO_SIDED|90.0|88.18|139.43|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.||139.43|88.18|
71913528|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|133.11|||||TWO_SIDED|90.0|100.55|176.21|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.||176.21|100.55|
71913529|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Other|94.3|||||TWO_SIDED|90.0|70.31|126.48|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.||126.48|70.31|
71913530|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|141.63|||||TWO_SIDED|90.0|111.2|180.39|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.||180.39|111.20|
71913531|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.46|||||TWO_SIDED|90.0|85.56|153.11|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.||153.11|85.56|
71869850|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.246||95.0|||||t-test, 2 sided|Withn group p-values are from t-tests on LSMean change||Very small LDL||||0.246
71869851|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|ANCOVA|||Very small LDL||||0.033
71869852|NCT00190749|143256896|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||<0.001
71869853|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.047||95.0|||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size||||0.047
71869854|NCT00190749|143256896|SUPERIORITY_OR_OTHER|||||||0.221||95.0|||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||VLDL mean particle size||||0.221
71869855|NCT01200589|143256901|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.89|1.49||||||||1.49|0.89|
71869856|NCT01090427|143256911|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71869857|NCT01090427|143256911|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71869858|NCT01090427|143256912|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71869859|NCT01090427|143256912|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71683159|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.7|||||TWO_SIDED|95.0|0.57|0.86||||||Serotype 15B: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.86|0.57|
71683160|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.9|||||TWO_SIDED|95.0|0.77|1.04||||||Serotype 18C: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.04|0.77|
71869860|NCT01090427|143256913|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||0.003
71869861|NCT01090427|143256913|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] will be used as factors in the model.||||||<0.001
71683161|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.88|||||TWO_SIDED|95.0|0.78|0.98||||||Serotype 19A: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.98|0.78|
71869862|NCT01090427|143256914|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71869863|NCT01090427|143256914|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71869864|NCT01090427|143256915|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
71869865|NCT01090427|143256915|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0||||<0.001
71869866|NCT01090427|143256915|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
71869867|NCT01090427|143256915|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2||||<0.001
71869868|NCT01090427|143256916|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
71869869|NCT01090427|143256916|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders||||<0.001
71869870|NCT01090427|143256916|SUPERIORITY_OR_OTHER|||||||0.014|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||0.014
71869871|NCT01090427|143256916|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0||||<0.001
71869872|NCT01090427|143256917|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.003
71869873|NCT01090427|143256917|SUPERIORITY_OR_OTHER|||||||0.028|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Total Scale Score||||0.028
71869874|NCT01090427|143256917|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.005
71869875|NCT01090427|143256917|SUPERIORITY_OR_OTHER|||||||0.063|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Psychosocial health summary score||||0.063
71869876|NCT01090427|143256917|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.007
71869877|NCT01090427|143256917|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight \[less than or equal to 60 kg vs greater than 60 kg\] were used as factors in the model.||PedsQL Physical health summary score||||0.020
71869878|NCT01090427|143256918|SUPERIORITY_OR_OTHER|||||||0.027|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||0.027
71869879|NCT01090427|143256918|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||||||<0.001
71869880|NCT01049217|143256923|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.191||0.709|TWO_SIDED|95.0|-0.3|0.45|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with terms of treatment, pooled site, dideoxynucleoside analogue (D-drug) anti-retroviral agent (ART) use and baseline score.||0.45|-0.30|0.7090
71869881|NCT01049217|143256924|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.5049
71869882|NCT01049217|143256925|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4271|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.4271
71913532|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|167.09|||||TWO_SIDED|90.0|120.73|231.25|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.||231.25|120.73|
71913533|NCT00937326|143347922|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|117.73|||||TWO_SIDED|90.0|85.14|162.79|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.||162.79|85.14|
71913534|NCT00937326|143347923|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|122.22|||||TWO_SIDED|90.0|86.94|171.8|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.||171.80|86.94|
71913535|NCT00937326|143347923|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|94.45|||||TWO_SIDED|90.0|69.07|129.16|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.||129.16|69.07|
71913536|NCT00937326|143347923|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.79|||||TWO_SIDED|90.0|91.54|143.95|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.||143.95|91.54|
71913537|NCT00937326|143347923|OTHER|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|120.3|||||TWO_SIDED|90.0|88.66|163.23|||ANOVA|Results obtained from a mixed model ANOVA on log10-transformed data with fixed effect of study day and a random effect of participant.|The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.||163.23|88.66|
71913538|NCT00937326|143347928|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.||||0.997
71913539|NCT00937326|143347928|SUPERIORITY|||||||0.581||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.||||0.581
71913540|NCT00937326|143347928|SUPERIORITY|||||||0.987||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.||||0.987
71869883|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.095||0.2084|TWO_SIDED|95.0|-0.31|0.07|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.31|0.2084
71869884|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.126||0.1516|TWO_SIDED|95.0|-0.43|0.07|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.43|0.1516
71869885|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.142||0.0468|TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.00|-0.56|0.0468
71869886|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.177||0.1224|TWO_SIDED|95.0|-0.62|0.07|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.07|-0.62|0.1224
71869887|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.184||0.0373|TWO_SIDED|95.0|-0.75|-0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||-0.02|-0.75|0.0373
71913541|NCT00937326|143347928|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.||||0.999
71869888|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.199||0.166|TWO_SIDED|95.0|-0.67|0.12|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.12|-0.67|0.1660
71869889|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.214||0.3246|TWO_SIDED|95.0|-0.63|0.21|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.21|-0.63|0.3246
71869890|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.219||0.4879|TWO_SIDED|95.0|-0.58|0.28|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.28|-0.58|0.4879
71869891|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.223||0.2669|TWO_SIDED|95.0|-0.69|0.19|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.19|-0.69|0.2669
71869892|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.219||0.5452|TWO_SIDED|95.0|-0.56|0.3|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.30|-0.56|0.5452
71869893|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.229||0.5469|TWO_SIDED|95.0|-0.59|0.31|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.59|0.5469
71869894|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.24||0.7843|TWO_SIDED|95.0|-0.54|0.41|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.54|0.7843
71869895|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9008|TWO_SIDED|95.0|-0.5|0.44|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.44|-0.50|0.9008
71869896|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.24||0.9064|TWO_SIDED|95.0|-0.45|0.5|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.45|0.9064
71869897|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.243||0.7205|TWO_SIDED|95.0|-0.57|0.39|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.39|-0.57|0.7205
71869898|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.259||0.4334|TWO_SIDED|95.0|-0.71|0.31|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.31|-0.71|0.4334
71869899|NCT01049217|143256926|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.199||0.8402|TWO_SIDED|95.0|-0.43|0.35|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.35|-0.43|0.8402
71869900|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.085||0.3098|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.08|-0.25|0.3098
71869901|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.118||0.2429|TWO_SIDED|95.0|-0.37|0.09|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.09|-0.37|0.2429
71869902|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.137||0.0504|TWO_SIDED|95.0|-0.54|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.00|-0.54|0.0504
71869903|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.164||0.1141|TWO_SIDED|95.0|-0.58|0.06|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.06|-0.58|0.1141
71869904|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.173||0.0667|TWO_SIDED|95.0|-0.66|0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.02|-0.66|0.0667
71869905|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.189||0.2104|TWO_SIDED|95.0|-0.61|0.13|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.13|-0.61|0.2104
71869906|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.197||0.483|TWO_SIDED|95.0|-0.53|0.25|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.25|-0.53|0.4830
71869907|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.203||0.5757|TWO_SIDED|95.0|-0.51|0.29|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.29|-0.51|0.5757
71869908|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.208||0.3231|TWO_SIDED|95.0|-0.62|0.2|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.62|0.3231
71869909|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.212||0.3143|TWO_SIDED|95.0|-0.63|0.2|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.20|-0.63|0.3143
71869910|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.222||0.63|TWO_SIDED|95.0|-0.54|0.33|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.54|0.6300
71683162|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.89|||||TWO_SIDED|95.0|0.78|1.01||||||Serotype 19F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||1.01|0.78|
71869911|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.227||0.5752|TWO_SIDED|95.0|-0.57|0.32|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.32|-0.57|0.5752
71869912|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.219||0.8905|TWO_SIDED|95.0|-0.46|0.4|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.46|0.8905
71869913|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.228||0.9991|TWO_SIDED|95.0|-0.45|0.45|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.45|-0.45|0.9991
71869914|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.228||0.8927|TWO_SIDED|95.0|-0.48|0.42|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.48|0.8927
71869915|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.245||0.8067|TWO_SIDED|95.0|-0.54|0.42|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.42|-0.54|0.8067
71869916|NCT01049217|143256927|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.19||0.9009|TWO_SIDED|95.0|-0.35|0.4|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.40|-0.35|0.9009
71869917|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.177||0.0948|TWO_SIDED|95.0|-0.64|0.05|||ANCOVA|||Change at Week 4, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.64|0.0948
71869918|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.203||0.4167|TWO_SIDED|95.0|-0.57|0.23|||ANCOVA|||Change at Week 8, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.23|-0.57|0.4167
71869919|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.226||0.8179|TWO_SIDED|95.0|-0.39|0.5|||ANCOVA|||Change at Week 12, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.39|0.8179
71869920|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.209||0.6913|TWO_SIDED|95.0|-0.33|0.5|||ANCOVA|||Change at Week 16, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.50|-0.33|0.6913
71869921|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.203||0.9475|TWO_SIDED|95.0|-0.39|0.41|||ANCOVA|||Change at Endpoint, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.41|-0.39|0.9475
71869922|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.204||0.7412|TWO_SIDED|95.0|-0.47|0.33|||ANCOVA|||Change at Week 4, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.33|-0.47|0.7412
71869923|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.213||0.9715|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Change at Week 8, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.43|-0.41|0.9715
71869924|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.218||0.8163|TWO_SIDED|95.0|-0.38|0.48|||ANCOVA|||Change at Week 12, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.48|-0.38|0.8163
71869925|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.204||0.3682|TWO_SIDED|95.0|-0.22|0.58|||ANCOVA|||Change at Week 16, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.22|0.3682
71869926|NCT01049217|143256928|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.199||0.3511|TWO_SIDED|95.0|-0.21|0.58|||ANCOVA|||Change at Endpoint, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.58|-0.21|0.3511
71869927|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9686|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Burning: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9686
71869928|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.23||0.4476|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Squeezing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.4476
71869929|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.563|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Pressure: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.3|-0.6|0.5630
71869930|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9937|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Electric Shocks: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9937
71869931|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8718|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Stabbing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8718
71869932|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.8241|TWO_SIDED|95.0|-0.5|0.4|||ANCOVA|||Change at Endpoint, Light Touching: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.4|-0.5|0.8241
71683163|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.75|||||TWO_SIDED|95.0|0.62|0.9||||||Serotype 22F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.90|0.62|
71869933|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.25||0.3164|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Change at Endpoint, Pressure of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.2|-0.7|0.3164
71869934|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.8996|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Cold of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.8996
71869935|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.26||0.9676|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Pins and Needles: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9676
71869936|NCT01049217|143256929|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.25||0.9091|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Tingling: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.5|-0.5|0.9091
71869937|NCT01049217|143256930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Duration of Spontaneous Pain: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7300
71869938|NCT01049217|143256930|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0559|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Number of Pain Attacks: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.0559
71869939|NCT01049217|143256931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.025||0.9686|TWO_SIDED|95.0|-0.05|0.05|||ANCOVA|||Change at Endpoint, Burning Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.05|0.9686
71869940|NCT01049217|143256931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.022||0.4711|TWO_SIDED|95.0|-0.06|0.03|||ANCOVA|||Change at Endpoint, Pressing Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.06|0.4711
71869941|NCT01049217|143256931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.023||0.9215|TWO_SIDED|95.0|-0.04|0.05|||ANCOVA|||Change at Endpoint, Paroxysmal Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.05|-0.04|0.9215
71913542|NCT00937326|143347928|SUPERIORITY|||||||0.85||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.||||0.850
71913543|NCT00937326|143347928|SUPERIORITY|||||||0.843||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.||||0.843
71913544|NCT00937326|143347928|SUPERIORITY|||||||0.961||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.||||0.961
71913545|NCT00937326|143347928|SUPERIORITY|||||||0.939||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.||||0.939
71913546|NCT00937326|143347928|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.||||0.966
71913547|NCT00937326|143347928|SUPERIORITY|||||||0.075||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.||||0.075
71913548|NCT00937326|143347928|SUPERIORITY|||||||0.7||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.||||0.700
71913549|NCT00937326|143347928|SUPERIORITY|||||||0.732||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.||||0.732
71913550|NCT00937326|143347928|SUPERIORITY|||||||0.552||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.||||0.552
71913551|NCT00937326|143347928|SUPERIORITY|||||||0.196||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.||||0.196
71869942|NCT01049217|143256931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.021||0.6042|TWO_SIDED|95.0|-0.05|0.03|||ANCOVA|||Change at Endpoint, Evoked Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.05|0.6042
71869943|NCT01049217|143256931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.024||0.9394|TWO_SIDED|95.0|-0.05|0.04|||ANCOVA|||Change at Endpoint, P/D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.04|-0.05|0.9394
71869944|NCT01049217|143256931|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.7801|TWO_SIDED|95.0|-0.04|0.03|||ANCOVA|||Change at Endpoint, Total Score: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.03|-0.04|0.7801
71869945|NCT01049217|143256932|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.44|STANDARD_ERROR_OF_MEAN|6.58||0.6012|TWO_SIDED||||||ANCOVA|||Endpoint TST: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.6012
71869946|NCT01049217|143256932|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.66|STANDARD_ERROR_OF_MEAN|1.89||0.0534|TWO_SIDED||||||ANCOVA|||Endpoint MIS: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0534
71913552|NCT00937326|143347928|SUPERIORITY|||||||0.393||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.||||0.393
71913553|NCT00937326|143347928|SUPERIORITY|||||||0.775||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.||||0.775
71913554|NCT00937326|143347928|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.||||1.000
71869947|NCT01049217|143256933|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.62||0.0966|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0966
71869948|NCT01049217|143256934|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|0.51||0.0611|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.0611
71869949|NCT01049217|143256935|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8436.0|STANDARD_ERROR_OF_MEAN|6855.2||0.2195|TWO_SIDED||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.||||0.2195
71869950|NCT01049217|143256936|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.66||0.8241|TWO_SIDED||||||ANCOVA|||||||0.8241
71869951|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|2.052||0.8528|TWO_SIDED|95.0|-4.42|3.66|||ANCOVA|||Change at Endpoint, Sleep Disturbance: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.66|-4.42|0.8528
71869952|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.88|STANDARD_ERROR_OF_MEAN|3.179||0.365|TWO_SIDED|95.0|-3.37|9.14|||ANCOVA|||Change at Endpoint, Snoring: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||9.14|-3.37|0.3650
71869953|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.89|STANDARD_ERROR_OF_MEAN|2.525||0.7237|TWO_SIDED|95.0|-4.07|5.86|||ANCOVA|||Change at Endpoint, SOB: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.86|-4.07|0.7237
71869954|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.165||0.2783|TWO_SIDED|95.0|-0.5|0.15|||ANCOVA|||Change at Endpoint, Quantity: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.15|-0.50|0.2783
71683164|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.78|||||TWO_SIDED|95.0|0.66|0.92||||||Serotype 23F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.92|0.66|
71683165|NCT04526574|142884335|NON_INFERIORITY|NI for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.5 (2-fold criterion) for that serotype.|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.83||||||Serotype 33F: GMR (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 95% CIs were calculated by exponentiating the difference of LS means for OPA titers and corresponding CIs based on regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed OPA titers, and prior pneumococcal vaccination status.||0.83|0.62|
71869955|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|3.02|STANDARD_ERROR_OF_MEAN|2.611||0.2475|TWO_SIDED|95.0|-2.11|8.16|||ANCOVA|||Change at Endpoint, Adequacy: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||8.16|-2.11|0.2475
71869956|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.16|STANDARD_ERROR_OF_MEAN|1.933||0.5492|TWO_SIDED|95.0|-2.64|4.96|||ANCOVA|||Change at Endpoint, Somnolence: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.96|-2.64|0.5492
71869957|NCT01049217|143256937|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|1.614||0.9113|TWO_SIDED|95.0|-3.0|3.36|||ANCOVA|||Change at Endpoint, Sleep Problems Index: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.36|-3.00|0.9113
71869958|NCT01049217|143256938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7399|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Endpoint: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.||||0.7399
71869959|NCT01049217|143256939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.386||0.8258|TWO_SIDED|95.0|-0.67|0.84|||ANCOVA|||Change at Endpoint, HADS-A: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||0.84|-0.67|0.8258
71869960|NCT01049217|143256939|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.372||0.084|TWO_SIDED|95.0|-0.09|1.38|||ANCOVA|||Change at Endpoint, HADS-D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.38|-0.09|0.0840
71869961|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.22|STANDARD_ERROR_OF_MEAN|2.393||0.6114|TWO_SIDED|95.0|-3.49|5.92|||ANCOVA|||Change at Endpoint, Ph Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.92|-3.49|0.6114
71869962|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|2.522||0.8209|TWO_SIDED|95.0|-4.39|5.53|||ANCOVA|||Change at Endpoint, R-P: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||5.53|-4.39|0.8209
71869963|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|2.335||0.9737|TWO_SIDED|95.0|-4.52|4.67|||ANCOVA|||Change at Endpoint, BP: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.67|-4.52|0.9737
71869964|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.76|STANDARD_ERROR_OF_MEAN|1.937||0.6966|TWO_SIDED|95.0|-3.05|4.57|||ANCOVA|||Change at Endpoint, GH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||4.57|-3.05|0.6966
71869965|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.807||0.8569|TWO_SIDED|95.0|-1.44|1.73|||ANCOVA|||Change at Endpoint, Ph C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.73|-1.44|0.8569
71869966|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.33|STANDARD_ERROR_OF_MEAN|1.847||0.4734|TWO_SIDED|95.0|-4.96|2.31|||ANCOVA|||Change at Endpoint, Vit: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.31|-4.96|0.4734
71869967|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.97|STANDARD_ERROR_OF_MEAN|2.159||0.3625|TWO_SIDED|95.0|-6.22|2.28|||ANCOVA|||Change at Endpoint, So Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||2.28|-6.22|0.3625
71869968|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.79|STANDARD_ERROR_OF_MEAN|2.543||0.2736|TWO_SIDED|95.0|-2.21|7.79|||ANCOVA|||Change at Endpoint, R-E: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||7.79|-2.21|0.2736
71869969|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.811||0.8199|TWO_SIDED|95.0|-3.98|3.15|||ANCOVA|||Change at Endpoint, MnH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||3.15|-3.98|0.8199
71869970|NCT01049217|143256940|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.967||0.9361|TWO_SIDED|95.0|-1.82|1.98|||ANCOVA|||Change at Endpoint, Mn C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.||1.98|-1.82|0.9361
71869971|NCT00903682|143256956|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||The hypothesis is that the proportion of patients with at least 1 treatment-emergent Grade 1-4 neuropsychiatric adverse event, observed between Baseline through Week 12 and judged to be at least possibly drug-related, is significantly lower in the ETR arm than in the EFV arm. Assuming a significance level of 5%, a sample size of 75 subjects per arm would provide over 90% power to detect a 29% difference in treatment-emergent, drug-related Grade 1-4 neuropsychiatric adverse events.||||<0.001
71869972|NCT00903682|143256957|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.61|||||TWO_SIDED|95.0|-12.0|15.23|||||Difference in proportion of response ETR minus EFV|||15.23|-12.00|
71869973|NCT02495792|143256965|OTHER||Risk Ratio (RR)|5.98|||||TWO_SIDED|95.0|1.6|21.7||||||||21.7|1.6|
71869974|NCT02909764|143256966|OTHER|||||||0.3|||||||ANOVA|||||||0.30
71913555|NCT00937326|143347928|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.||||0.989
71913556|NCT00937326|143347928|SUPERIORITY|||||||0.603||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.||||0.603
71913557|NCT00937326|143347928|SUPERIORITY|||||||0.108||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.||||0.108
71913558|NCT00937326|143347929|SUPERIORITY|||||||0.525||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.||||0.525
71913559|NCT00937326|143347929|SUPERIORITY|||||||0.818||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.||||0.818
71913560|NCT00937326|143347929|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.||||0.999
71913561|NCT00937326|143347929|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.||||0.809
71913562|NCT00937326|143347929|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.||||0.993
71913563|NCT00937326|143347929|SUPERIORITY|||||||0.954||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.||||0.954
71913564|NCT00937326|143347929|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.||||1.000
71913565|NCT00937326|143347929|SUPERIORITY|||||||0.344||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.||||0.344
71913566|NCT00937326|143347929|SUPERIORITY|||||||0.968||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.||||0.968
71913567|NCT00937326|143347929|SUPERIORITY|||||||0.316||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.||||0.316
71913568|NCT00937326|143347929|SUPERIORITY|||||||0.984||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.||||0.984
71913569|NCT00937326|143347929|SUPERIORITY|||||||0.235||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.||||0.235
71683166|NCT04526574|142884336|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.07|||||TWO_SIDED|95.0|0.97|1.17||||||A/H1N1: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.17|0.97|
71683167|NCT04526574|142884336|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.98|||||TWO_SIDED|95.0|0.89|1.08||||||A/H3N2: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.89|
71683168|NCT04526574|142884336|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|1.0|||||TWO_SIDED|95.0|0.93|1.08||||||B/Victoria: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.08|0.93|
71913570|NCT00937326|143347929|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.||||1.000
71913571|NCT00937326|143347929|SUPERIORITY|||||||0.656||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.||||0.656
71913572|NCT00937326|143347929|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.||||0.994
71913573|NCT00937326|143347929|SUPERIORITY|||||||0.285||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.||||0.285
71913574|NCT00937326|143347929|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.||||0.992
71913575|NCT00937326|143347929|SUPERIORITY|||||||0.822||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.||||0.822
71913576|NCT00937326|143347929|SUPERIORITY|||||||0.538||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.||||0.538
71913577|NCT00937326|143347929|SUPERIORITY|||||||0.907||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.||||0.907
71913578|NCT00937326|143347930|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.||||0.999
71913579|NCT00937326|143347930|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.||||0.982
71913580|NCT00937326|143347930|SUPERIORITY|||||||0.677||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.||||0.677
71913581|NCT00937326|143347930|SUPERIORITY|||||||0.688||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.||||0.688
71869975|NCT02909764|143256967|OTHER|Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|||||<|0.05|||||||Chi-squared|||Yates's chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.||||<0.05
71869976|NCT02909764|143256968|OTHER|||||||0.32|||||||ANOVA|||||||0.32
71869977|NCT02909764|143256969|OTHER|||||||0.77|||||||ANOVA|||||||0.77
71869978|NCT02909764|143256970|OTHER|General estimating equations (GEE)|||||<|0.05|||||||GEE|||Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.||||<0.05
71913582|NCT00937326|143347930|SUPERIORITY|||||||0.903||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.||||0.903
71913583|NCT00937326|143347930|SUPERIORITY|||||||0.945||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.||||0.945
71913584|NCT00937326|143347930|SUPERIORITY|||||||0.949||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.||||0.949
71913585|NCT00937326|143347930|SUPERIORITY|||||||0.924||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.||||0.924
71913586|NCT00937326|143347930|SUPERIORITY|||||||0.394||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.||||0.394
71913587|NCT00937326|143347930|SUPERIORITY|||||||0.687||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.||||0.687
71913588|NCT00937326|143347930|SUPERIORITY|||||||0.568||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.||||0.568
71869979|NCT02909764|143256971|OTHER|T-tests were conducted to determine whether differences in baseline blood pressure between groups|||||>|0.4|||||||t-test, 2 sided|||T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.||||>0.40
71869980|NCT00107120|143257000|SUPERIORITY_OR_OTHER||Least Square Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.458||0.022||95.0|-6.2|-0.5||Two-sided at 5% level of significance p \< 0.05 considered significant|ANCOVA|The model included study center and treatment as factors and baseline core as covariate|Differences are Escitalopram-Placebo|The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.||-0.5|-6.2|0.022
71869981|NCT00107120|143257001|SUPERIORITY_OR_OTHER||Least Square Means Difference|-0.344|STANDARD_ERROR_OF_MEAN|0.1128||0.008||95.0|-0.595|0.092||Two-sided at 5% level of significance|ANCOVA|The model included treatment and center as factors and baseline CGI-Severity score as covariate.|Differences are Escitalopram-Placebo|Missing values were imputed using the LOCF approach.||0.092|-0.595|0.008
71913589|NCT00937326|143347930|SUPERIORITY|||||||0.486||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.||||0.486
71683169|NCT04526574|142884336|NON_INFERIORITY|NI was declared if the lower bound of the 2-sided 95% CI for the GMR of the (SIIV+20vPnC)/saline group to the (SIIV+saline)/20vPnC group was greater than 0.67 (1.5-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.87|1.03||||||B/Phuket: GMRs (ratio of GMTs \[SIIV+20vPnC\]/saline to \[SIIV+saline\]/20vPnC) and 2-sided CIs were calculated by exponentiating the difference of LS means for the HAI titers and the corresponding CIs based on the regression model adjusted with vaccine group, sex, smoking status, age at Vaccination 1 in years, baseline log-transformed HAI titers, and prior pneumococcal vaccination status.||1.03|0.87|
71869982|NCT00107120|143257002|SUPERIORITY_OR_OTHER||Least Square Means Difference|2.169|STANDARD_ERROR_OF_MEAN|1.324||0.103||95.0|-0.439|4.777||Two-sided at 5% level of significance|ANCOVA||Differences are Escitalopram-Placebo|ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.||4.777|-0.439|0.103
71869983|NCT00896051|143257010|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.82|||||TWO_SIDED|90.0|0.55|1.22|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: minimum plasma concentration (Cmin)||1.22|0.55|
71869984|NCT00896051|143257010|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.8|1.16|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.16|0.80|
71869985|NCT00896051|143257011|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.96|||||TWO_SIDED|90.0|0.76|1.22|||Linear mixed effects model|linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.22|0.76|
71869986|NCT00896051|143257012|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.91|||||TWO_SIDED|90.0|0.63|1.33|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: Minimum plasma concentration (Cmin)||1.33|0.63|
71869987|NCT00896051|143257012|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|1.05|||||TWO_SIDED|90.0|0.86|1.27|||Linear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: maximum plasma concentration (Cmax)||1.27|0.86|
71869988|NCT00896051|143257013|SUPERIORITY_OR_OTHER||Least Squares (LS) Means Ratio|0.99|||||TWO_SIDED|90.0|0.81|1.21|||Llinear mixed effects model|A linear mixed effects model was used controlling for treatment as fixed effect, and participant as a random effect.||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)||1.21|0.81|
71869989|NCT03719170|143257032|SUPERIORITY||Slope|0.0000684|||||TWO_SIDED|95.0|-0.0003|0.000413||||||"Power Calculation:~Assuming approximately the same number of eligible subjects in each VISN (with an average of 10,563 candidates per VISN) and an Intraclass correlation coefficient (ICC) of 0.12, randomizing 17 VISNs will give more than 80% power to detect % days on PPI of 75% vs. 50%, 85% vs. 60%, 80% vs. 55%, or 70% vs. 45%, but to detect a difference between 70% vs. 50%, power is only 61% using 0.05 level 2-sided test."||0.000413|-0.0003|
71869990|NCT01346475|143257033|SUPERIORITY_OR_OTHER||Incident Risk Ratio|0.54|||<|0.001|TWO_SIDED|95.0|0.44|0.66|||Incident risk ratio|The model is adjusted for period effects.||This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.||0.66|0.44|<0.001
71869991|NCT00370331|143257073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.2|||<|0.001||99.0|3.59|18.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized Estimating Equations (GEE)||||18.73|3.59|<0.001
71869992|NCT01874431|143257083|OTHER||Least square mean ratio|0.926||||0.1973|TWO_SIDED|90.0|0.799|1.074|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an analysis of covariance (ANCOVA) with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a last-observation carried-forward (LOCF) method for missing observations.||1.074|0.799|0.1973
71869993|NCT01874431|143257083|OTHER||Least square mean ratio|0.949||||0.2808|TWO_SIDED|90.0|0.818|1.101|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.101|0.818|0.2808
71869994|NCT01874431|143257083|OTHER||Least square mean ratio|0.878||||0.0723|TWO_SIDED|90.0|0.758|1.017|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||1.017|0.758|0.0723
71869995|NCT01874431|143257083|OTHER||Least square mean ratio|0.787||||0.0039|TWO_SIDED|90.0|0.68|0.912|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.912|0.68|0.0039
71869996|NCT01874431|143257083|OTHER||Least square mean ratio|0.755||||0.0009|TWO_SIDED|90.0|0.651|0.875|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.875|0.651|0.0009
71869997|NCT01874431|143257083|OTHER||Least square mean ratio|0.671|||<|0.0001|TWO_SIDED|90.0|0.584|0.772|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.772|0.584|< 0.0001
71869998|NCT01874431|143257083|OTHER||Least square mean ratio|0.624|||<|0.0001|TWO_SIDED|90.0|0.542|0.718|||t-test, 1 sided|||To demonstrate a dose-dependent effect of finerenone, an ANCOVA with factors treatment group, type of albuminuria at screening and region, and log-transformed baseline value as covariate nested within type of albuminuria at screening was performed in the FAS using a LOCF method for missing observations.||0.718|0.542|< 0.0001
71869999|NCT01874431|143257084|OTHER||Least squares mean difference|0.107||||0.0428|TWO_SIDED|95.0|0.003|0.21|||t-test, 2 sided|||||0.21|0.003|0.0428
71913590|NCT00937326|143347930|SUPERIORITY|||||||0.973||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.||||0.973
71913591|NCT00937326|143347930|SUPERIORITY|||||||0.739||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.||||0.739
71913592|NCT00937326|143347930|SUPERIORITY|||||||0.731||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.||||0.731
71913593|NCT00937326|143347930|SUPERIORITY|||||||0.991||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.||||0.991
71913594|NCT00937326|143347930|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.||||0.994
71683170|NCT05727306|142884369|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|1.25|1.46|||||Calculated as the odds of having a depressive episode in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.25|
71870000|NCT01874431|143257084|OTHER||Least squares mean difference|0.121||||0.0223|TWO_SIDED|95.0|0.017|0.225|||t-test, 2 sided|||||0.225|0.017|0.0223
71870001|NCT01874431|143257084|OTHER||Least squares mean difference|0.2||||0.0002|TWO_SIDED|95.0|0.096|0.305|||t-test, 2 sided|||||0.305|0.096|0.0002
71870002|NCT01874431|143257084|OTHER||Least squares mean difference|0.125||||0.0181|TWO_SIDED|95.0|0.021|0.229|||t-test, 2 sided|||||0.229|0.021|0.0181
71870003|NCT01874431|143257084|OTHER||Least squares mean difference|0.166||||0.0019|TWO_SIDED|95.0|0.061|0.27|||t-test, 2 sided|||||0.27|0.061|0.0019
71913595|NCT00937326|143347930|SUPERIORITY|||||||0.963||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.||||0.963
71870004|NCT01874431|143257084|OTHER||Least squares mean difference|0.236|||<|0.0001|TWO_SIDED|95.0|0.137|0.334|||t-test, 2 sided|||||0.334|0.137|< 0.0001
71870005|NCT01874431|143257084|OTHER||Least squares mean difference|0.186||||0.0002|TWO_SIDED|95.0|0.088|0.284|||t-test, 2 sided|||||0.284|0.088|0.0002
71870006|NCT01874431|143257085|OTHER||Least squares mean difference|-0.786||||0.5454|TWO_SIDED|95.0|-3.337|1.765|||t-test, 2 sided|||||1.765|-3.337|0.5454
71870007|NCT01874431|143257085|OTHER||Least squares mean difference|-1.61||||0.2186|TWO_SIDED|95.0|-4.177|0.957|||t-test, 2 sided|||||0.957|-4.177|0.2186
71870008|NCT01874431|143257085|OTHER||Least squares mean difference|-0.918||||0.4859|TWO_SIDED|95.0|-3.503|1.667|||t-test, 2 sided|||||1.667|-3.503|0.4859
71870009|NCT01874431|143257085|OTHER||Least squares mean difference|-1.8||||0.1677|TWO_SIDED|95.0|-4.358|0.759|||t-test, 2 sided|||||0.759|-4.358|0.1677
71870010|NCT01874431|143257085|OTHER||Least squares mean difference|-2.613||||0.0462|TWO_SIDED|95.0|-5.183|-0.044|||t-test, 2 sided|||||-0.044|-5.183|0.0462
71870011|NCT01874431|143257085|OTHER||Least squares mean difference|-2.228||||0.0705|TWO_SIDED|95.0|-4.643|0.187|||t-test, 2 sided|||||0.187|-4.643|0.0705
71870012|NCT01874431|143257085|OTHER||Least squares mean difference|-2.446||||0.048|TWO_SIDED|95.0|-4.869|-0.022|||t-test, 2 sided|||||-0.022|-4.869|0.048
71870013|NCT01874431|143257086|OTHER||Least square mean difference|-2.863||||0.0757|TWO_SIDED|95.0|-6.022|0.297|||t-test, 2 sided|||||0.297|-6.022|0.0757
71913596|NCT00937326|143347930|SUPERIORITY|||||||0.929||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.||||0.929
71870014|NCT01874431|143257086|OTHER||Least square mean difference|-0.643||||0.6941|TWO_SIDED|95.0|-3.851|2.565|||t-test, 2 sided|||||2.565|-3.851|0.6941
71870015|NCT01874431|143257086|OTHER||Least square mean difference|-1.976||||0.2228|TWO_SIDED|95.0|-5.155|1.203|||t-test, 2 sided|||||1.203|-5.155|0.2228
71870016|NCT01874431|143257086|OTHER||Least square mean difference|-1.932||||0.2313|TWO_SIDED|95.0|-5.098|1.234|||t-test, 2 sided|||||1.234|-5.098|0.2313
71870017|NCT01874431|143257086|OTHER||Least square mean difference|-3.342||||0.0386|TWO_SIDED|95.0|-6.509|-0.176|||t-test, 2 sided|||||-0.176|-6.509|0.0386
71870018|NCT01874431|143257086|OTHER||Least square mean difference|-0.634||||0.677|TWO_SIDED|95.0|-3.624|2.355|||t-test, 2 sided|||||2.355|-3.624|0.677
71870019|NCT01874431|143257086|OTHER||Least square mean difference|-0.688||||0.6536|TWO_SIDED|95.0|-3.699|2.322|||t-test, 2 sided|||||2.322|-3.699|0.6536
71870020|NCT01874431|143257087|OTHER||Least square mean difference|-3.044||||0.0816|TWO_SIDED|95.0|-6.471|0.383|||t-test, 2 sided|||||0.383|-6.471|0.0816
71870021|NCT01874431|143257087|OTHER||Least square mean difference|-0.537||||0.7625|TWO_SIDED|95.0|-4.027|2.953|||t-test, 2 sided|||||2.953|-4.027|0.7625
71870022|NCT01874431|143257087|OTHER||Least square mean difference|-1.301|||=|0.4603|TWO_SIDED|95.0|-4.759|2.157|||t-test, 2 sided|||||2.157|-4.759|= 0.4603
71870023|NCT01874431|143257087|OTHER||Least square mean difference|-1.574||||0.3678|TWO_SIDED|95.0|-5.004|1.855|||t-test, 2 sided|||||1.855|-5.004|0.3678
71870024|NCT01874431|143257087|OTHER||Least square mean difference|-1.727||||0.3279|TWO_SIDED|95.0|-5.191|1.736|||t-test, 2 sided|||||1.736|-5.191|0.3279
71870025|NCT01874431|143257087|OTHER||Least square mean difference|-1.682||||0.3102|TWO_SIDED|95.0|-4.935|1.57|||t-test, 2 sided|||||1.57|-4.935|0.3102
71870026|NCT01874431|143257087|OTHER||Least square mean difference|-2.511||||0.1317|TWO_SIDED|95.0|-5.778|0.755|||t-test, 2 sided|||||0.755|-5.778|0.1317
71870027|NCT00757588|143257104|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.089|<|0.0001|TWO_SIDED|95.0|-0.59|-0.24||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-0.24|-0.59|<0.0001
71870028|NCT00757588|143257105|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3829.8|STANDARD_ERROR_OF_MEAN|1165.99||0.0011|TWO_SIDED|95.0|-6122.4|-1537.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1537.1|-6122.4|0.0011
71870029|NCT00757588|143257106|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|7.24||0.0016|TWO_SIDED|95.0|-37.2|-8.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-8.7|-37.2|0.0016
71870030|NCT00757588|143257107|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02|STANDARD_ERROR_OF_MEAN|4.732||0.3958|TWO_SIDED|95.0|-13.32|5.28||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||5.28|-13.32|0.3958
71870031|NCT00757588|143257109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|95.0|-5.6|-1.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use|||-1.1|-5.6|
71870032|NCT01052103|143257118|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.6||0.732||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.732
71870033|NCT01052103|143257119|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.2|STANDARD_ERROR_OF_MEAN|2.1||0.846||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.846
71870034|NCT01052103|143257120|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.201||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.201
71870035|NCT01052103|143257121|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.4|STANDARD_ERROR_OF_MEAN|1.3||0.136||95.0||||One-sided p-value.|Type 3 Tests|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.136
71870036|NCT01052103|143257122|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.5|STANDARD_ERROR_OF_MEAN|2.4||0.739||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.739
71870037|NCT01052103|143257123|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.19||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.190
71870038|NCT01052103|143257124|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.702||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.702
71870039|NCT01052103|143257125|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.851||95.0|||||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.851
71870040|NCT01052103|143257129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.0||||0.999|TWO_SIDED|95.0|-4.3|4.3||P-value is for standing systolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||4.3|-4.3|0.999
71870041|NCT01052103|143257129|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.8||||0.009|TWO_SIDED|95.0|1.0|6.7||P-value is for standing diastolic BP.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||6.7|1.0|0.009
71870042|NCT01052103|143257130|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5||||0.818|TWO_SIDED|95.0|-5.0|3.9|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||3.9|-5.0|0.818
71870043|NCT01052103|143257131|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.44||||0.571|TWO_SIDED|95.0|-1.98|1.1|||Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||1.10|-1.98|0.571
71870044|NCT01052103|143257136|SUPERIORITY_OR_OTHER_LEGACY|||||||0.682||95.0||||P-value is for treatment-emergent suicidal ideation.|Fisher Exact|||||||0.682
71870045|NCT01052103|143257137|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.0|STANDARD_ERROR_OF_MEAN|1.7||0.727||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.727
71870046|NCT01052103|143257141|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.7|STANDARD_ERROR_OF_MEAN|3.4||0.305||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.305
71870047|NCT01052103|143257142|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|2.5||0.42||95.0||||One-sided p-value.|Type 3 Sums of Squares|||Changes from baseline to all post-baseline visits were analyzed using a restricted maximum likelihood-based MMRM. Model terms included fixed class effects for visit, investigative site, treatment, SOC type, baseline positive symptom stratum, and treatment-by-visit interaction as well as the continuous, fixed covariates of baseline measurement and baseline-by-visit interaction.||||0.420
71913597|NCT00937326|143347930|SUPERIORITY|||||||0.97||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.||||0.970
71870048|NCT00545051|143257173|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.25|||<|0.001|TWO_SIDED|95.0|2.09|4.41|||ANCOVA|||||4.41|2.09|<0.001
71870049|NCT00545051|143257174|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||<|0.001|TWO_SIDED|95.0|1.22|3.23|||ANCOVA|||||3.23|1.22|<0.001
71870050|NCT00545051|143257175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.122|TWO_SIDED|95.0|-0.15|1.25|||ANCOVA|||Month 6||1.25|-0.15|0.122
71870051|NCT00545051|143257175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|||<|0.001|TWO_SIDED|95.0|0.96|2.66|||ANCOVA|||Month 12||2.66|0.96|<0.001
71870052|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 1||||<0.001
71870053|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 6||||<0.001
71870054|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||sCTX at Month 12||||<0.001
71870055|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 1||||<0.001
71870056|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 6||||<0.001
71870057|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||P1NP at Month 12||||<0.001
71870058|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 1||||<0.001
71913598|NCT00937326|143347931|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.||||0.989
71870059|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 6||||<0.001
71870060|NCT00545051|143257176|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||TRACP at Month 12||||<0.001
71913599|NCT00937326|143347931|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.||||0.989
71913600|NCT00937326|143347931|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.||||0.982
71913601|NCT00937326|143347931|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.||||0.999
71913602|NCT00937326|143347931|SUPERIORITY|||||||0.685||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.||||0.685
71913603|NCT00937326|143347931|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.||||0.999
71913604|NCT00937326|143347931|SUPERIORITY|||||||0.971||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.||||0.971
71913605|NCT00937326|143347931|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.||||1.000
71913606|NCT00937326|143347931|SUPERIORITY|||||||0.405||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.||||0.405
71913607|NCT00937326|143347931|SUPERIORITY|||||||0.975||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.||||0.975
71913608|NCT00937326|143347931|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.||||0.999
71870061|NCT05398237|143257178|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0122||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK).|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0122
71870062|NCT05398237|143257178|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.009||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.009
71913609|NCT00937326|143347931|SUPERIORITY|||||||0.629||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.||||0.629
71913610|NCT00937326|143347931|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.||||0.982
71913611|NCT00937326|143347931|SUPERIORITY|||||||0.982||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.||||0.982
71913612|NCT00937326|143347931|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.||||0.999
71913613|NCT00937326|143347931|SUPERIORITY|||||||0.874||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.||||0.874
71913614|NCT00937326|143347931|SUPERIORITY|||||||0.986||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.||||0.986
71913615|NCT00937326|143347931|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.||||0.997
71913616|NCT00937326|143347931|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.||||1.000
71870063|NCT05398237|143257179|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0063||||||Change in pathway from baseline to 1 hour post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study||||0.0063
71870064|NCT05398237|143257179|OTHER|A self-contained, subject-level permutation test for changes of all analytes in a pathway, assuming all analyte levels increasing after SSL exposure.||||||0.0056||||||Change in pathway from baseline to 24 hours post-SSL. Threshold for p-value of each test is 0.05/4=0.0125 based on Bonferroni adjustment for four tests, with two time points and two pathways (TLR4 and TOPK/PRPK)|Permutation test|The self-contained, subject-level permutation test comparing the pre- and post-SSL levels of all analytes in the pathway.||This is a single-arm study.||||0.0056
71870065|NCT01383499|143257193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.023||0.0002|TWO_SIDED|95.0|0.042|0.132||First step of closed testing procedure, where the active treatments are compared to placebo. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R5 minus Placebo||0.132|0.042|0.0002
71870066|NCT01383499|143257193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.104|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.059|0.149||Second step of closed testing procedure. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R2.5 minus Placebo||0.149|0.059|<.0001
71870067|NCT01383499|143257193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.023||0.0011|TWO_SIDED|95.0|0.03|0.12|||Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo||0.120|0.030|0.0011
71870068|NCT01383499|143257193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.034|0.057|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R1.25||0.057|-0.034|
71870069|NCT01383499|143257193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.063|0.028|||Mixed model repeated measures (MMRM)|||Tio R5 minus Tio R2.5||0.028|-0.063|
71870070|NCT01383499|143257193|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.023|||TWO_SIDED|95.0|-0.016|0.074|||Mixed models repeated measures (MMRM)|||Tio R2.5 minus Tio R1.25||0.074|-0.016|
71913617|NCT00937326|143347931|SUPERIORITY|||||||0.697||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.||||0.697
71913618|NCT00937326|143347932|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.||||1.000
71913619|NCT00937326|143347932|SUPERIORITY|||||||0.812||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.||||0.812
71870071|NCT02469389|143257204|SUPERIORITY|Based on randomization to treatment condition, the model assumed no differences at BL (any difference was assumed due to random sampling error).||||||0.295|||||||Mixed Models Analysis|Post-hoc mixed effects model analyses of all outcomes were performed adjusting for BL CAINS MAP score.||Analyses of the primary and secondary outcomes utilized a linear mixed effects model accounting for random therapy group effects and included all available data at baseline (BL), post-treatment (PT; 12-week), and follow-up (FU; 24-week) timepoints (TPs). Error terms across TPs were assumed correlated with unstructured correlation matrix. To test time specific hypotheses, terms in the mean model included separate indicators for PT \& FU \& interaction terms between these indicators and conditions.||||0.295
71870072|NCT02469389|143257205|SUPERIORITY|||||||0.182|||||||Mixed Models Analysis|||||||0.182
71870073|NCT02469389|143257206|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|||||||0.114
71870074|NCT02469389|143257207|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||||||0.220
71870075|NCT02469389|143257208|SUPERIORITY|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71870076|NCT02469389|143257209|SUPERIORITY|||||||0.903|||||||Mixed Models Analysis|||||||0.903
71870077|NCT02469389|143257210|SUPERIORITY|||||||0.535|||||||Mixed Models Analysis|||||||0.535
71870078|NCT02469389|143257211|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.010
71870079|NCT02469389|143257212|SUPERIORITY|||||||0.692|||||||Mixed Models Analysis|||||||0.692
71870080|NCT02469389|143257213|SUPERIORITY|||||||0.498|||||||Mixed Models Analysis|||||||0.498
71870081|NCT02469389|143257214|SUPERIORITY|||||||0.079|||||||Mixed Models Analysis|||||||0.079
71870082|NCT02469389|143257215|SUPERIORITY|||||||0.539|||||||Mixed Models Analysis|||||||0.539
71870083|NCT01079663|143257223|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.1629|TWO_SIDED|95.0|-1.19|0.2|||Mixed Models Analysis|||||0.20|-1.19|0.1629
71870084|NCT01079663|143257224|SUPERIORITY||Mean Difference (Final Values)|-0.76||||0.0347|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||||-0.06|-1.46|0.0347
71913620|NCT00937326|143347932|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.||||0.996
71870085|NCT03038438|143257229|OTHER|Single arm study with a hypothesis test comparing to performance goal|Proportion|88.0|||<|0.0001|ONE_SIDED|97.5|82.5||||Fisher Exact|||"The primary effectiveness endpoint, primary patency at 12 months, was tested against a PG of 75%. The null and alternative hypotheses tested appear below:~H0: π ≤ PG vs. HA: π \> PG where π is the primary patency rate at 12 months in the study population and PG is the performance goal of 75%. The primary effectiveness objective will be met if the lower limit of the 97.5% one-sided confidence interval is above 75%."|||82.5|<0.0001
71913621|NCT00937326|143347932|SUPERIORITY|||||||0.198||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.||||0.198
71913622|NCT00937326|143347932|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.||||1.000
71913623|NCT00937326|143347932|SUPERIORITY|||||||0.358||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.||||0.358
71913624|NCT00937326|143347932|SUPERIORITY|||||||0.852||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.||||0.852
71913625|NCT00937326|143347932|SUPERIORITY|||||||0.678||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.||||0.678
71913626|NCT00937326|143347932|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.||||1.000
71913627|NCT00937326|143347932|SUPERIORITY|||||||0.191||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.||||0.191
71913628|NCT00937326|143347932|SUPERIORITY|||||||0.805||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.||||0.805
71913629|NCT00937326|143347932|SUPERIORITY|||||||0.96||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.||||0.960
71913630|NCT00937326|143347932|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.||||0.985
71913631|NCT00937326|143347932|SUPERIORITY|||||||0.733||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.||||0.733
71913632|NCT00937326|143347932|SUPERIORITY|||||||0.365||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.||||0.365
71913633|NCT00937326|143347932|SUPERIORITY|||||||0.413||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.||||0.413
71913634|NCT00937326|143347932|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.||||0.765
71913635|NCT00937326|143347932|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.||||0.434
71913636|NCT00937326|143347932|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.||||0.184
71913637|NCT00937326|143347932|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.||||0.142
71913638|NCT00937326|143347932|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.||||0.999
71913639|NCT00937326|143347932|SUPERIORITY|||||||0.876||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.||||0.876
71913640|NCT00937326|143347932|SUPERIORITY|||||||0.756||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.||||0.756
71913641|NCT00937326|143347932|SUPERIORITY|||||||0.983||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.||||0.983
71913642|NCT00937326|143347933|SUPERIORITY|||||||0.809||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.||||0.809
71913643|NCT00937326|143347933|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.||||1.000
71913644|NCT00937326|143347933|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.||||0.989
71913645|NCT00937326|143347933|SUPERIORITY|||||||0.13||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.||||0.130
71913646|NCT00937326|143347933|SUPERIORITY|||||||0.87||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.||||0.870
71913647|NCT00937326|143347933|SUPERIORITY|||||||0.864||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.||||0.864
71913648|NCT00937326|143347933|SUPERIORITY|||||||0.997||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.||||0.997
71913649|NCT00937326|143347933|SUPERIORITY|||||||0.682||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.||||0.682
71913650|NCT00937326|143347933|SUPERIORITY|||||||0.798||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.||||0.798
71870086|NCT03038438|143257230|OTHER|Single-arm study with a hypothesis test comparing to performance goal|Proportion|2.0|||<|0.0001|ONE_SIDED|97.5||5.0|||Fisher Exact|||"The primary safety endpoint, major adverse events at 30 days post-procedure, was tested against a performance goal of 12.5%. The null and alternative hypotheses tested appear below:~H0: P ≥ PG vs. HA: P \< PG where P is the primary safety endpoint at 30 days in the study population and PG is the performance goal.~The primary safety objective will be met if the upper limit of the 97.5% one-sided confidence interval is below 12.5%."||5.0||<0.0001
71870087|NCT02476279|143257254|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.036|||||TWO_SIDED|95.0|0.006|0.066|||||These numbers are in the intention-to-treat analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.066|0.006|
71870088|NCT02476279|143257254|NON_INFERIORITY|To declare noninferiority, the upper bound of the two-sided 95% CI for the risk difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) needed to be less than 5% in both the intention-to-treat and per protocol analysis populations.|Risk Difference (RD)|0.028|||||TWO_SIDED|95.0|-0.003|0.06|||||These numbers are in the per protocol analysis population. Risk difference in post-ERCP pancreatitis (PEP) is calculated as risk of PEP in indomethacin alone arm minus risk of PEP in indomethacin plus stent arm.|||0.060|-0.003|
71870089|NCT02476279|143257255|OTHER||Risk Difference (RD)|0.021|||||TWO_SIDED|95.0|-0.002|0.043|||||These numbers are in the intention-to-treat analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.043|-0.002|
71870090|NCT02476279|143257255|OTHER||Risk Difference (RD)|0.02|||||TWO_SIDED|95.0|-0.004|0.044|||||These numbers are in the per protocol analysis population. Risk difference is calculated as risk of moderate-severe PEP in indomethacin alone arm minus risk of moderate-severe PEP in indomethacin plus stent arm.|||0.044|-0.004|
71870091|NCT00577473|143257256|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0455||||0.4411|TWO_SIDED|95.0|-7.01|16.11||4.8 g/day compared to 2.4 g/day|Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||16.11|-7.01|0.4411
71870092|NCT00577473|143257257|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0331||||0.5677|TWO_SIDED|95.0|-14.67|8.04|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||8.04|-14.67|0.5677
71870093|NCT00577473|143257258|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.0445||||0.473|TWO_SIDED|95.0|-16.6|7.7|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||7.7|-16.6|0.4730
71870094|NCT00577473|143257259|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0339||||0.5761|TWO_SIDED|95.0|-8.48|15.26|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.26|-8.48|0.5761
71683171|NCT05727306|142884370|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.32|1.58|||||Calculated as the odds of having recurrent depressive disorder in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.58|1.32|
71870095|NCT00577473|143257260|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0766||||0.215|TWO_SIDED|95.0|-4.41|19.74|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.74|-4.41|0.2150
71870096|NCT00577473|143257261|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0351||||0.5569|TWO_SIDED|95.0|-8.18|15.2|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||15.20|-8.18|0.5569
71870097|NCT00577473|143257262|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1091||||0.0769|TWO_SIDED|95.0|-1.1|22.91|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.91|-1.10|0.0769
71870098|NCT00577473|143257263|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.1139||||0.0551|TWO_SIDED|95.0|-0.13|22.92|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||22.92|-0.13|0.0551
71870099|NCT00577473|143257264|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0738||||0.2306|TWO_SIDED|95.0|-4.66|19.43|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||19.43|-4.66|0.2306
71870100|NCT00577473|143257265|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0652||||0.2931|TWO_SIDED|95.0|-5.6|18.64|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||18.64|-5.60|0.2931
71870101|NCT00577473|143257266|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0051||||0.9349|TWO_SIDED|95.0|-11.67|12.69|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||12.69|-11.67|0.9349
71870102|NCT00577473|143257267|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.065||||0.2583|TWO_SIDED|95.0|-4.72|17.73|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.||17.73|-4.72|0.2583
71870103|NCT00986973|143257270|SUPERIORITY_OR_OTHER||||||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
71870104|NCT00986973|143257271|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.82
71870105|NCT00986973|143257272|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.46
71913651|NCT00937326|143347933|SUPERIORITY|||||||0.73||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.||||0.730
71913652|NCT00937326|143347933|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
71870106|NCT00986973|143257273|SUPERIORITY_OR_OTHER|||||||0.071|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.071
71870107|NCT00986973|143257274|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.25
71870108|NCT00986973|143257275|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes||||||0.050
71870109|NCT00986973|143257276|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.34
71870110|NCT02891408|143257354|OTHER||Geometric least-square mean (GLSM) ratio|181.0|||||TWO_SIDED|90.0|98.0|332.0||||||AUClast of Firsocostat||332|98|
71870111|NCT02891408|143257354|OTHER||GLSM ratio|881.0|||||TWO_SIDED|90.0|488.0|1589.0||||||AUClast of Firsocostat||1589|488|
71870112|NCT02891408|143257354|OTHER||GLSM ratio|3081.0|||||TWO_SIDED|90.0|2446.0|3881.0||||||AUClast of Firsocostat||3881|2446|
71870113|NCT02891408|143257354|OTHER||GLSM ratio|430.0|||||TWO_SIDED|90.0|185.0|998.0||||||AUClast of GS-834773||998|185|
71870114|NCT02891408|143257354|OTHER||GLSM ratio|4417.0|||||TWO_SIDED|90.0|1867.0|10449.0||||||AUClast of GS-834773||10449|1867|
71870115|NCT02891408|143257354|OTHER||GLSM ratio|14676.0|||||TWO_SIDED|90.0|7932.0|27153.0||||||AUClast of GS-834773||27153|7932|
71870116|NCT02891408|143257354|OTHER||GLSM ratio|122.0|||||TWO_SIDED|90.0|86.0|173.0||||||AUClast of Fenofibric Acid||173|86|
71870117|NCT02891408|143257355|OTHER||GLSM ratio|183.0|||||TWO_SIDED|90.0|100.0|337.0||||||AUCinf of Firsocostat||337|100|
71870118|NCT02891408|143257355|OTHER||GLSM ratio|869.0|||||TWO_SIDED|90.0|482.0|1568.0||||||AUCinf of Firsocostat||1568|482|
71870119|NCT02891408|143257355|OTHER||GLSM ratio|2976.0|||||TWO_SIDED|90.0|2389.0|3708.0||||||AUCinf of Firsocostat||3708|2389|
71870120|NCT02891408|143257355|OTHER||GLSM ratio|399.0|||||TWO_SIDED|90.0|179.0|892.0||||||AUCinf of GS-834773||892|179|
71870121|NCT02891408|143257355|OTHER||GLSM ratio|3843.0|||||TWO_SIDED|90.0|1641.0|9000.0||||||AUCinf of GS-834773||9000|1641|
71870122|NCT02891408|143257355|OTHER||GLSM ratio|10712.0|||||TWO_SIDED|90.0|6525.0|17585.0||||||AUCinf of GS-834773||17585|6525|
71870123|NCT02891408|143257355|OTHER||GLSM ratio|125.0|||||TWO_SIDED|90.0|89.0|174.0||||||AUCinf of Fenofibric Acid||174|89|
71870124|NCT02891408|143257356|OTHER||GLSM ratio|169.0|||||TWO_SIDED|90.0|87.0|326.0||||||Cmax of Firsocostat||326|87|
71870125|NCT02891408|143257356|OTHER||GLSM ratio|905.0|||||TWO_SIDED|90.0|537.0|1526.0||||||Cmax of Firsocostat||1526|537|
71870126|NCT02891408|143257356|OTHER||GLSM ratio|2719.0|||||TWO_SIDED|90.0|1994.0|3708.0||||||Cmax of Firsocostat||3708|1994|
71870127|NCT02891408|143257356|OTHER||GLSM ratio|391.0|||||TWO_SIDED|90.0|163.0|942.0||||||Cmax of GS-834773||942|163|
71870128|NCT02891408|143257356|OTHER||GLSM ratio|4470.0|||||TWO_SIDED|90.0|2170.0|9207.0||||||Cmax of GS-834773||9207|2170|
71870129|NCT02891408|143257356|OTHER||GLSM ratio|9278.0|||||TWO_SIDED|90.0|4945.0|17407.0||||||Cmax of GS-834773||17407|4945|
71913653|NCT00937326|143347933|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.||||1.000
71870130|NCT02891408|143257356|OTHER||GLSM ratio|109.0|||||TWO_SIDED|90.0|81.0|146.0||||||Cmax of Fenofibric Acid||146|81|
71870131|NCT00709852|143257381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|0.61|<|0.0001||||||for contrast enhancement|paired t-test|||||||< 0.0001
71870132|NCT00709852|143257381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67|STANDARD_DEVIATION|0.66|<|0.0001||||||for border delineation|paired t-test|||||||< 0.0001
71870133|NCT00709852|143257381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62|STANDARD_DEVIATION|0.47|<|0.0001||||||for internal morphology|paired t-test|||||||< 0.0001
71913654|NCT00937326|143347933|SUPERIORITY|||||||0.464||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.||||0.464
71913655|NCT00937326|143347933|SUPERIORITY|||||||0.634||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.||||0.634
71913656|NCT00937326|143347933|SUPERIORITY|||||||0.254||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.||||0.254
71913657|NCT00937326|143347933|SUPERIORITY|||||||0.034||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.||||0.034
71913658|NCT00937326|143347933|SUPERIORITY|||||||0.765||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.||||0.765
71913659|NCT00937326|143347933|SUPERIORITY|||||||0.434||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.||||0.434
71870134|NCT00709852|143257382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|STANDARD_DEVIATION|0.77|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71913660|NCT00937326|143347933|SUPERIORITY|||||||0.184||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.||||0.184
71870135|NCT00709852|143257382|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870136|NCT00709852|143257382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870137|NCT00709852|143257383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06|STANDARD_DEVIATION|0.51|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870138|NCT00709852|143257383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.5|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870139|NCT00709852|143257383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.52|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870140|NCT00709852|143257384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29|STANDARD_DEVIATION|0.56|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870141|NCT00709852|143257384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|0.53|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870142|NCT00709852|143257384|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.42|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870143|NCT00709852|143257385|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|5.51|||TWO_SIDED|95.0|-0.199|0.984|||confidence interval for paired means|lower limit of interval is compared to noninferiority margin||BR 1||0.984|-0.199|
71870144|NCT00709852|143257385|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|12.38|||TWO_SIDED|95.0|-1.772|0.885|||confidence interval for paired means|lower limit of confidence interval (CI) is compared to noninferiority margin||BR 2||0.885|-1.772|
71870145|NCT00709852|143257385|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|4.07|||TWO_SIDED|95.0|0.125|1.0|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||BR 3||1.000|0.125|
71870146|NCT00709852|143257385|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.17|STANDARD_DEVIATION|5.68|||TWO_SIDED|95.0|-0.439|0.78|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||AR||0.780|-0.439|
71870147|NCT00709852|143257386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870148|NCT00709852|143257386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_DEVIATION|0.37|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870149|NCT00709852|143257386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.38|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71913661|NCT00937326|143347933|SUPERIORITY|||||||0.142||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.||||0.142
71913662|NCT00937326|143347933|SUPERIORITY|||||||0.955||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.||||0.955
71913663|NCT00937326|143347933|SUPERIORITY|||||||0.985||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.||||0.985
71913664|NCT00937326|143347933|SUPERIORITY|||||||0.923||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.||||0.923
71913665|NCT00937326|143347933|SUPERIORITY|||||||0.883||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.||||0.883
71913666|NCT00937326|143347934|SUPERIORITY|||||||0.118||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.118
71913667|NCT00937326|143347934|SUPERIORITY|||||||0.119||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.119
71913668|NCT00937326|143347934|SUPERIORITY|||||||0.293||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.293
71913669|NCT00937326|143347934|SUPERIORITY|||||||0.966||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.966
71913670|NCT00937326|143347935|SUPERIORITY|||||||0.94||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.940
71870150|NCT00709852|143257387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_DEVIATION|0.62|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71913671|NCT00937326|143347935|SUPERIORITY|||||||0.197||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.197
71913672|NCT00937326|143347935|SUPERIORITY|||||||0.097||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.097
71913673|NCT00937326|143347935|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.404
71913674|NCT00937326|143347936|SUPERIORITY|||||||0.206||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.||||0.2060
71913675|NCT00937326|143347936|SUPERIORITY|||||||0.179||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.||||0.1790
71913676|NCT00937326|143347936|SUPERIORITY|||||||0.2741||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.2741
71870151|NCT00709852|143257387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_DEVIATION|0.46|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870152|NCT00709852|143257387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|0.39|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870153|NCT00709852|143257388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_DEVIATION|0.33|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870154|NCT00709852|143257388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|0.33|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870155|NCT00709852|143257388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43|STANDARD_DEVIATION|0.32|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71913677|NCT00937326|143347936|SUPERIORITY|||||||0.6001||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.||||0.6001
71913678|NCT00937326|143347936|SUPERIORITY|||||||0.6711||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.||||0.6711
71870156|NCT00709852|143257389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|STANDARD_DEVIATION|0.3|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870157|NCT00709852|143257389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72|STANDARD_DEVIATION|0.23|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870158|NCT00709852|143257389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.22|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870159|NCT00709852|143257390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83|STANDARD_DEVIATION|1.16|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870160|NCT00709852|143257390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870161|NCT00709852|143257390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|0.82|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870162|NCT00709852|143257391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_DEVIATION|1.29|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71913679|NCT00937326|143347936|OTHER|||||||0.1361||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.||||0.1361
71913680|NCT00937326|143347936|SUPERIORITY|||||||0.3369||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.3369
71913681|NCT00937326|143347936|SUPERIORITY|||||||0.0975||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.||||0.0975
71870163|NCT00709852|143257391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.54|STANDARD_DEVIATION|1.44|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870164|NCT00709852|143257391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|1.11|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870165|NCT00709852|143257392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|STANDARD_DEVIATION|0.95|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870166|NCT00709852|143257392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_DEVIATION|0.97|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870167|NCT00709852|143257392|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_DEVIATION|0.96|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870168|NCT00709852|143257393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|1.06|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870169|NCT00709852|143257393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|1.07|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870170|NCT00709852|143257393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|0.83|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870171|NCT00709852|143257394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.24|STANDARD_DEVIATION|0.53|<|0.0001||||||for contrast enhancement|paired t test|||||||< 0.0001
71870172|NCT00709852|143257394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.48|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870173|NCT00709852|143257394|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.41|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870174|NCT00709852|143257395|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|6.44|||TWO_SIDED|95.0|-0.532|0.851|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.851|-0.532|
71870175|NCT00709852|143257396|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.33||||95.0|0.0004|0.078|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.078|0.0004|
71870176|NCT00709852|143257396|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.41||||95.0|-0.009|0.082|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.082|-0.009|
71870177|NCT00709852|143257396|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.29||||95.0|-0.006|0.059|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.059|-0.006|
71870178|NCT00709852|143257397|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|5.7||||95.0|-0.601|0.622|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.622|-0.601|
71870179|NCT00709852|143257398|SUPERIORITY_OR_OTHER||Difference in percentages|8.3|||||||||||||for BR1|||||
71870180|NCT00709852|143257398|SUPERIORITY_OR_OTHER||Difference in percentages|-0.9|||||||||||||for BR2|||||
71870181|NCT00709852|143257398|SUPERIORITY_OR_OTHER||Difference in percentages|15.8|||||||||||||for BR3|||||
71913682|NCT00937326|143347936|SUPERIORITY|||||||0.2184||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.||||0.2184
71913683|NCT00937326|143347936|SUPERIORITY|||||||0.1013||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.||||0.1013
71913684|NCT00937326|143347936|SUPERIORITY|||||||0.3286||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.3286
71913685|NCT00937326|143347936|SUPERIORITY|||||||0.5193||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.||||0.5193
71913686|NCT00937326|143347936|SUPERIORITY|||||||0.9788||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.||||0.9788
71913687|NCT00937326|143347936|SUPERIORITY|||||||0.1214||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.||||0.1214
71913688|NCT00937326|143347936|SUPERIORITY|||||||0.5751||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.5751
71870182|NCT00709852|143257398|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.9|||||TWO_SIDED|95.0|-0.5|18.4|||CI for paired percentages|confidence interval is given for AR; lower limit is compared to the noninferiority margin||||18.4|-0.5|
71913689|NCT00937326|143347936|SUPERIORITY|||||||0.2409||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.||||0.2409
71913690|NCT00937326|143347936|SUPERIORITY|||||||0.4829||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.||||0.4829
71913691|NCT00937326|143347936|SUPERIORITY|||||||0.7563||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.||||0.7563
71913692|NCT00937326|143347936|SUPERIORITY|||||||0.2907||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.2907
71913693|NCT00937326|143347936|SUPERIORITY|||||||0.7663||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.||||0.7663
71913694|NCT00937326|143347936|SUPERIORITY|||||||0.5825||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI||||0.5825
71913695|NCT00937326|143347936|SUPERIORITY|||||||0.322||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.||||0.3220
71683172|NCT05727306|142884371|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.3|1.51|||||Calculated as the odds of having anxiety in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Odds Ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.51|1.30|
71870183|NCT00709852|143257399|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|3.6||||||95.0|-5.9|13.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||13.1|-5.9|
71870184|NCT00709852|143257400|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|8.3||||||95.0|-0.9|17.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||17.6|-0.9|
71870185|NCT00709852|143257401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|0.78|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71913696|NCT00937326|143347936|SUPERIORITY|||||||0.0564||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.||||0.0564
71913697|NCT00937326|143347936|SUPERIORITY|||||||0.196||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.||||0.1960
71913698|NCT00937326|143347936|SUPERIORITY|||||||0.5997||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.||||0.5997
71913699|NCT00937326|143347936|SUPERIORITY|||||||0.9637||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.||||0.9637
71913700|NCT00937326|143347936|SUPERIORITY|||||||0.324||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.3240
71913701|NCT00937326|143347936|SUPERIORITY|||||||0.844||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.||||0.8440
71913702|NCT00937326|143347936|SUPERIORITY|||||||0.6483||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.||||0.6483
71913703|NCT00937326|143347936|SUPERIORITY|||||||0.6452||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.||||0.6452
71913704|NCT00937326|143347936|SUPERIORITY|||||||0.1253||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.1253
71913705|NCT00937326|143347936|SUPERIORITY|||||||0.2583||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.||||0.2583
71913706|NCT00937326|143347937|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.||||1.000
71913707|NCT00937326|143347937|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.||||1.000
71913708|NCT00937326|143347937|SUPERIORITY|||||||0.901||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.||||0.901
71913709|NCT00937326|143347937|SUPERIORITY|||||||0.155||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.||||0.155
71913710|NCT00937326|143347937|SUPERIORITY|||||||0.845||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.||||0.845
71913711|NCT00937326|143347937|SUPERIORITY|||||||0.164||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.||||0.164
71913712|NCT00937326|143347937|SUPERIORITY|||||||0.699||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.||||0.699
71913713|NCT00937326|143347937|SUPERIORITY|||||||0.313||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.||||0.313
71913714|NCT00937326|143347938|SUPERIORITY|||||||0.896||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.896
71913715|NCT00937326|143347938|SUPERIORITY|||||||0.08||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.080
71913716|NCT00937326|143347938|SUPERIORITY|||||||0.792||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.792
71913717|NCT00937326|143347938|SUPERIORITY|||||||0.645||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.645
71913718|NCT00937326|143347939|SUPERIORITY|||||||0.992||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.||||0.992
71913719|NCT00937326|143347939|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.||||0.999
71913720|NCT00937326|143347939|SUPERIORITY|||||||0.548||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.||||0.548
71913721|NCT00937326|143347939|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.||||0.989
71913722|NCT00937326|143347939|SUPERIORITY|||||||0.877||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.||||0.877
71913723|NCT00937326|143347939|SUPERIORITY|||||||0.887||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.||||0.887
71913724|NCT00937326|143347939|SUPERIORITY|||||||0.916||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.||||0.916
71913725|NCT00937326|143347939|SUPERIORITY|||||||0.86||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.||||0.860
71913726|NCT00937326|143347940|SUPERIORITY|||||||0.996||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.996
71913727|NCT00937326|143347940|SUPERIORITY|||||||0.989||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.989
71913728|NCT00937326|143347940|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
71870186|NCT00709852|143257401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61|STANDARD_DEVIATION|0.61|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71913729|NCT00937326|143347940|SUPERIORITY|||||||0.763||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.763
71913730|NCT00937326|143347941|SUPERIORITY|||||||0.81||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.810
71913731|NCT00937326|143347941|SUPERIORITY|||||||0.753||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.753
71913732|NCT00937326|143347941|SUPERIORITY|||||||0.404||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.404
71913733|NCT00937326|143347941|SUPERIORITY|||||||0.671||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.||||0.671
71913734|NCT00937326|143347941|SUPERIORITY|||||||1||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.||||1.000
71913735|NCT00937326|143347941|SUPERIORITY|||||||0.622||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.622
71913736|NCT00937326|143347941|SUPERIORITY|||||||0.332||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.332
71913737|NCT00937326|143347941|SUPERIORITY|||||||0.998||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.||||0.998
71913738|NCT00937326|143347942|SUPERIORITY|||||||0.994||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.994
71913739|NCT00937326|143347942|SUPERIORITY|||||||0.979||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.979
71913740|NCT00937326|143347942|SUPERIORITY|||||||0.993||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.993
71913741|NCT00937326|143347942|SUPERIORITY|||||||0.999||||||Analysis was performed using ANOVA with Dunnett's test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett's test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||||||0.999
71870187|NCT00709852|143257402|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.29|STANDARD_DEVIATION|3.21||||95.0|-0.053|0.636|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.636|-0.053|
71870188|NCT00709852|143257403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.77|STANDARD_DEVIATION|0.64|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870189|NCT00709852|143257403|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_DEVIATION|0.5|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870190|NCT00709852|143257404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74|STANDARD_DEVIATION|1.26|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71913742|NCT02853123|143347973|SUPERIORITY||Mean Difference (Final Values)|-0.357|STANDARD_ERROR_OF_MEAN|0.153||0.0217|TWO_SIDED|95.0|-0.661|-0.053|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.053|-0.661|0.0217
71870191|NCT00709852|143257404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|0.97|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870192|NCT00709852|143257405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_DEVIATION|0.76|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870193|NCT00709852|143257405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58|STANDARD_DEVIATION|0.63|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870194|NCT00709852|143257406|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|3.39||||95.0|-0.087|0.641|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.641|-0.087|
71870195|NCT00709852|143257407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.78|STANDARD_DEVIATION|0.61|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71870196|NCT00709852|143257407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63|STANDARD_DEVIATION|0.49|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870197|NCT00709852|143257408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65|STANDARD_DEVIATION|1.27|<|0.0001||||||for border delineation|paired t test|||||||< 0.0001
71913743|NCT02853123|143347974|SUPERIORITY||Mean Difference (Final Values)|0.185|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001|TWO_SIDED|95.0|0.106|0.265|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured prior to exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.265|0.106|<.0001
71913744|NCT02853123|143347975|SUPERIORITY||Mean Difference (Final Values)|0.066|STANDARD_ERROR_OF_MEAN|0.038||0.0852|TWO_SIDED|95.0|-0.009|0.141|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured end of exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.141|-0.009|0.0852
71870198|NCT00709852|143257408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.51|STANDARD_DEVIATION|1.01|<|0.0001||||||for internal morphology|paired t test|||||||< 0.0001
71870199|NCT00709852|143257409|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.06||||||95.0|0.03|0.096|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.096|0.030|
71870200|NCT00709852|143257409|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04||||||95.0|0.003|0.071|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.071|0.003|
71870201|NCT00709852|143257409|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|0.003|0.055|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.055|0.003|
71870202|NCT00709852|143257410|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.59||||95.0|-0.049|0.078|||confidence interval for paired means|lower limit of confidence interval is compared to noninferiority margin||||0.078|-0.049|
71870203|NCT00709852|143257411|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|-0.009|0.065|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.065|-0.009|
71870204|NCT00709852|143257411|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.01||||||95.0|-0.04|0.02|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.020|-0.040|
71870205|NCT00709852|143257411|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01||||||95.0|-0.015|0.035|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.035|-0.015|
71870206|NCT00709852|143257412|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.042|0.153|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for contrast enhancement||0.153|0.042|
71870207|NCT00709852|143257412|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.03|0.161|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for border delineation||0.161|0.030|
71870208|NCT00709852|143257412|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -0.35|Mean Difference (Final Values)|0.05||||||95.0|0.006|0.098|||CI for paired means|lower limit of confidence interval is compared to noninferiority margin||analysis for internal morphology||0.098|0.006|
71870209|NCT00709852|143257413|SUPERIORITY_OR_OTHER||Difference|6.2||||0.0082|||||||McNemar|||||||0.0082
71870210|NCT00709852|143257414|SUPERIORITY_OR_OTHER||Difference|9.9|||<|0.0001|||||||McNemar|||||||< 0.0001
71870211|NCT00709852|143257415|SUPERIORITY_OR_OTHER||Difference|6.8||||0.0039|||||||McNemar|||||||0.0039
71870212|NCT00709852|143257416|SUPERIORITY_OR_OTHER||Difference|9.2|||<|0.0001|||||||McNemar|||||||< 0.0001
71870213|NCT00709852|143257417|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-0.4||||||95.0|-3.8|2.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||2.9|-3.8|
71870214|NCT00709852|143257418|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of interval is compared to noninferiority margin||||1.6|-0.3|
71870215|NCT00709852|143257419|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
71870216|NCT00709852|143257420|SUPERIORITY_OR_OTHER||Difference|13.6|||<|0.0001|||||||McNemar|||||||< 0.0001
71870217|NCT00709852|143257421|SUPERIORITY_OR_OTHER||Difference|0.0||||1|||||||McNemar|||||||1.0000
71870218|NCT00709852|143257422|SUPERIORITY_OR_OTHER||Difference|10.5||||0.0002|||||||McNemar|||||||0.0002
71870219|NCT00709852|143257423|SUPERIORITY_OR_OTHER||Difference|13.1||||0.0001|||||||McNemar|||||||0.0001
71870220|NCT00709852|143257424|SUPERIORITY_OR_OTHER||Difference|1.6||||0.763|||||||McNemar|||||||0.7630
71913745|NCT02853123|143347976|SUPERIORITY||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.117|0.194|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.194|0.117|<.0001
71913746|NCT02853123|143347977|SUPERIORITY||Mean Difference (Final Values)|0.201|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.134|0.267|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.267|0.134|<.0001
71913747|NCT02853123|143347978|SUPERIORITY||Mean Difference (Final Values)|-0.108|STANDARD_ERROR_OF_MEAN|0.096||0.2645|TWO_SIDED|95.0|-0.3|0.083|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|1 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.083|-0.300|0.2645
71913748|NCT02853123|143347978|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.107||0.0267|TWO_SIDED|95.0|-0.452|-0.028|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.028|-0.452|0.0267
71913749|NCT02853123|143347978|SUPERIORITY||Mean Difference (Final Values)|-0.318|STANDARD_ERROR_OF_MEAN|0.14||0.0258|TWO_SIDED|95.0|-0.596|-0.039|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||-0.039|-0.596|0.0258
71913750|NCT02853123|143347979|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.12||0.8025|TWO_SIDED|95.0|-0.268|0.208|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.208|-0.268|0.8025
71913751|NCT02853123|143347980|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.099||0.3634|TWO_SIDED|95.0|-0.106|0.286|||Mixed Effect Model Repeated Measures|Kenward-Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within-patient variation.||0.286|-0.106|0.3634
71913752|NCT05516134|143348027|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||baseline vs. treatment, paired sample t-test||||<0.01
71913753|NCT05516134|143348028|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71913754|NCT05516134|143348029|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71913755|NCT05516134|143348030|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
71913756|NCT05516134|143348031|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71913757|NCT05516134|143348032|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||.11
71913758|NCT05516134|143348033|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<.01
71913759|NCT05516134|143348034|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71913760|NCT01094808|143348109|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|33.391|STANDARD_DEVIATION|22.106||0.14||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.14
71870221|NCT00709852|143257425|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-3.1|3.1|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.1|-3.1|
71870222|NCT00709852|143257426|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-2.7|3.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.6|-2.7|
71913761|NCT01094808|143348110|SUPERIORITY_OR_OTHER||mean value for 200 mg Pregabalin|35.301|STANDARD_DEVIATION|22.295||0.12||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects||||0.12
71913762|NCT01224106|143348119|SUPERIORITY||Effect Size|-0.044||||0.6744|TWO_SIDED|95.0|-0.248|0.161|||Mixed Models Analysis|||||0.161|-0.248|0.6744
71870223|NCT00709852|143257427|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|-1.6||||||95.0|-10.1|6.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||6.9|-10.1|
71870224|NCT00709852|143257428|SUPERIORITY_OR_OTHER||Difference|6.5||||0.0006|||||||McNemar|||||||0.0006
71870225|NCT00709852|143257429|SUPERIORITY_OR_OTHER||Difference|19.4||||0.0004|||||||McNemar|||||||0.0004
71870226|NCT00709852|143257430|SUPERIORITY_OR_OTHER||Difference|0.5||||0.6547|||||||McNemar|||||||0.6547
71913763|NCT01224106|143348119|SUPERIORITY||Effect Size|-0.085||||0.4494|TWO_SIDED|95.0|-0.304|0.135|||Mixed Models Analysis|||||0.135|-0.304|0.4494
71870227|NCT00709852|143257431|SUPERIORITY_OR_OTHER||Difference|7.9|||<|0.0001|||||||McNemar|||||||< 0.0001
71870228|NCT00709852|143257432|SUPERIORITY_OR_OTHER||Difference|21.5|||<|0.0001|||||||McNemar|||||||< 0.0001
71870229|NCT00709852|143257433|SUPERIORITY_OR_OTHER||Difference|1.5||||0.0833|||||||McNemar|||||||0.0833
71870230|NCT00709852|143257434|SUPERIORITY_OR_OTHER||Difference|4.5||||0.0236|||||||McNemar|||||||0.0236
71870231|NCT00709852|143257435|SUPERIORITY_OR_OTHER||Difference|12.9||||0.0186|||||||McNemar|||||||0.0186
71870232|NCT00709852|143257436|SUPERIORITY_OR_OTHER||Difference|0.5||||0.7055|||||||McNemar|||||||0.7055
71870233|NCT00709852|143257437|SUPERIORITY_OR_OTHER||Difference|7.2|||<|0.0001|||||||McNemar|||||||< 0.0001
71870234|NCT00709852|143257438|SUPERIORITY_OR_OTHER||Difference|20.4|||<|0.0001|||||||McNemar|||||||< 0.0001
71870235|NCT00709852|143257439|SUPERIORITY_OR_OTHER||Difference|1.0||||0.1573|||||||McNemar|||||||0.1573
71870236|NCT00709852|143257440|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|2.1||||||95.0|0.2|3.9|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.9|0.2|
71870237|NCT00709852|143257441|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|6.5||||||95.0|1.5|11.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||11.4|1.5|
71870238|NCT00709852|143257442|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-1.4|1.4|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.4|-1.4|
71870239|NCT00709852|143257443|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.6|-0.3|
71870240|NCT00709852|143257444|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|1.1||||||95.0|-1.0|3.2|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||3.2|-1.0|
71870241|NCT00709852|143257445|NON_INFERIORITY_OR_EQUIVALENCE|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-0.5|1.5|||CI for paired percentages|lower limit of confidence interval is compared to noninferiority margin||||1.5|-0.5|
71870242|NCT00709852|143257446|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.56|<|0.0001|||||||paired t test|||||||< 0.0001
71870243|NCT00709852|143257447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57|STANDARD_DEVIATION|0.58|<|0.0001|||||||paired t test|||||||< 0.0001
71870244|NCT00709852|143257448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.48||||||||||||||||
71870245|NCT00709852|143257449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.76|STANDARD_DEVIATION|0.93|<|0.0001|||||||paired t test|||||||< 0.0001
71870246|NCT00709852|143257450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_DEVIATION|0.89|<|0.0001|||||||paired t test|||||||< 0.0001
71870247|NCT00709852|143257451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.39||||||||||||||||
71870248|NCT00709852|143257452|SUPERIORITY_OR_OTHER||||||<|0.0001||||||for all three readers|t-test, 2 sided|||||||< 0.0001
71870249|NCT00709852|143257454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|1.06||||||||||||||||
71870250|NCT00709852|143257455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|26.6||||||||||||||||
71870251|NCT00825825|143257527|SUPERIORITY_OR_OTHER|||||||0.000704||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.000704
71870252|NCT00825825|143257528|SUPERIORITY_OR_OTHER|||||||1.62e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0000162
71870253|NCT00825825|143257529|SUPERIORITY_OR_OTHER|||||||9.36e-06||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.00000936
71913764|NCT01224106|143348121|SUPERIORITY||Effect Size|0.035||||0.7458|TWO_SIDED|95.0|-0.179|0.25|||Mixed Models Analysis|||||0.250|-0.179|0.7458
71913765|NCT01224106|143348121|SUPERIORITY||Effect Size|0.042||||0.723|TWO_SIDED|95.0|-0.191|0.275|||Mixed Models Analysis|||||0.275|-0.191|0.723
71913766|NCT01224106|143348125|SUPERIORITY||Effect Size|-0.191||||0.0825|TWO_SIDED|95.0|-0.407|0.025|||Mixed Models Analysis|||||0.025|-0.407|0.0825
71913767|NCT01224106|143348125|SUPERIORITY||Effect Size|0.043||||0.7171|TWO_SIDED|95.0|-0.19|0.276|||Mixed Models Analysis|||||0.276|-0.19|0.7171
71913768|NCT01224106|143348128|SUPERIORITY|||||||0.9734|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.9734
71913769|NCT01224106|143348128|SUPERIORITY|||||||0.0629|||||||Mixed Models Analysis|||"Statistical analysis of the Abeta 1-42 CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0629
71913770|NCT01224106|143348128|SUPERIORITY|||||||0.0084|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0084
71870254|NCT00825825|143257530|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.||||0.0279
71870255|NCT00825825|143257531|SUPERIORITY_OR_OTHER|||||||0.00124||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and placebo medication periods.||||0.00124
71870256|NCT00825825|143257532|SUPERIORITY_OR_OTHER|||||||6.33e-05||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the placebo and citalopram medication periods.||||0.0000633
71870257|NCT00825825|143257533|SUPERIORITY_OR_OTHER|||||||0.0241||95.0|||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.||||0.0241
71870258|NCT02697292|143257534|SUPERIORITY||Odds Ratio (OR)|10.5||||0.044|TWO_SIDED|95.0|1.1|98.9|||t-test, 1 sided|||||98.9|1.1|0.044
71870259|NCT02697292|143257535|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||0.100
71870260|NCT01043393|143257578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.779|||||TWO_SIDED|95.0|0.055|11.126||||||||11.126|0.055|
71870261|NCT02673515|143257630|OTHER|||||||0.797|||||||t-test, 2 sided|||Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Test||||0.797
71870262|NCT04227704|143257710|SUPERIORITY|||||||0.09|||||||ANOVA|||||||0.09
71870263|NCT04227704|143257711|SUPERIORITY|||||||0.08|||||||ANOVA|||||||0.08
71870264|NCT04227704|143257718|SUPERIORITY|||||||0.44|||||||ANOVA|||||||0.44
71870265|NCT02349425|143257766|SUPERIORITY||Estimated percent change|-41.222||||0.0055|TWO_SIDED|95.0|-59.294|-15.127|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-15.127|-59.294|0.0055
71870266|NCT02349425|143257766|SUPERIORITY||Estimated percent change|-51.973||||0.0008|TWO_SIDED|95.0|-68.23|-27.397|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-27.397|-68.230|0.0008
71870267|NCT02349425|143257766|SUPERIORITY||Estimated percent change|-46.853||||0.0075|TWO_SIDED|95.0|-66.291|-16.206|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-16.206|-66.291|0.0075
71870268|NCT02349425|143257766|SUPERIORITY||Estimated percent change|-57.067||||0.0009|TWO_SIDED|95.0|-73.375|-30.771|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.771|-73.375|0.0009
71870269|NCT02349425|143257767|SUPERIORITY||Estimated percent change|-14.691||||0.2542|TWO_SIDED|95.0|-35.307|12.493|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||12.493|-35.307|0.2542
71870270|NCT02349425|143257767|SUPERIORITY||Estimated percent change|-25.165||||0.0267|TWO_SIDED|95.0|-42.014|-3.421|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-3.4210|-42.014|0.0267
71870271|NCT02349425|143257767|SUPERIORITY||Estimated percent change|-37.146||||0.0198|TWO_SIDED|95.0|-57.345|-7.3821|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-7.3821|-57.345|0.0198
71870272|NCT02349425|143257767|SUPERIORITY||Estimated percent change|-55.92||||0.0006|TWO_SIDED|95.0|-71.923|-30.797|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model which uses log-transformation.|Percent change difference between Gefapixant and placebo was estimated by 100 x \[e\^diff - 1\] where e=exponent of difference; and diff = the treatment mean difference from mixed model of change from baseline based on log-transformed data.|||-30.797|-71.923|0.0006
71870273|NCT02349425|143257772|SUPERIORITY||Mean Difference (Final Values)|-19.0||||0.003|TWO_SIDED|95.0|-31.2|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-31.2|0.003
71870274|NCT02349425|143257772|SUPERIORITY||Mean Difference (Final Values)|-24.4|||<|0.001|TWO_SIDED|95.0|-36.7|-12.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-12.1|-36.7|<0.001
71870275|NCT02349425|143257772|SUPERIORITY||Mean Difference (Final Values)|-29.3||||0.005|TWO_SIDED|95.0|-49.0|-9.5|||Mixed Models Analysis|Per protocol, statistical analysis follows a Mixed Model.||||-9.5|-49.0|0.005
71870276|NCT02349425|143257772|SUPERIORITY||Mean Difference (Final Values)|-29.6|||<|0.001|TWO_SIDED|95.0|-44.6|-14.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-14.7|-44.6|<0.001
71870277|NCT02349425|143257773|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.332|TWO_SIDED|95.0|-21.0|7.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||7.2|-21.0|0.332
71870278|NCT02349425|143257773|SUPERIORITY||Mean Difference (Final Values)|-13.5||||0.008|TWO_SIDED|95.0|-23.3|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-23.3|0.008
71913771|NCT01224106|143348128|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||"Statistical analysis of the p-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0003
71870279|NCT02349425|143257773|SUPERIORITY||Mean Difference (Final Values)|-30.2|||<|0.001|TWO_SIDED|95.0|-44.7|-15.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-15.7|-44.7|<0.001
71870280|NCT02349425|143257773|SUPERIORITY||Mean Difference (Final Values)|-26.7||||0.001|TWO_SIDED|95.0|-42.3|-11.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.0|-42.3|0.001
71870281|NCT02349425|143257774|SUPERIORITY||Mean Difference (Final Values)|-15.2|||<|0.001|TWO_SIDED|95.0|-23.5|-6.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.8|-23.5|<0.001
71870282|NCT02349425|143257774|SUPERIORITY||Mean Difference (Final Values)|-16.7|||<|0.001|TWO_SIDED|95.0|-26.1|-7.4|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.4|-26.1|<0.001
71870283|NCT02349425|143257774|SUPERIORITY||Mean Difference (Final Values)|-19.5||||0.002|TWO_SIDED|95.0|-31.1|-7.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-7.8|-31.1|0.002
71870284|NCT02349425|143257774|SUPERIORITY||Mean Difference (Final Values)|-20.5|||<|0.001|TWO_SIDED|95.0|-31.8|-9.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.3|-31.8|<0.001
71870285|NCT02349425|143257775|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.315|TWO_SIDED|95.0|-12.3|4.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.0|-12.3|0.315
71870286|NCT02349425|143257775|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.03|TWO_SIDED|95.0|-13.7|-0.7|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.7|-13.7|0.030
71870287|NCT02349425|143257775|SUPERIORITY||Mean Difference (Final Values)|-18.2|||<|0.001|TWO_SIDED|95.0|-27.4|-9.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.1|-27.4|<0.001
71870288|NCT02349425|143257775|SUPERIORITY||Mean Difference (Final Values)|-17.6|||<|0.001|TWO_SIDED|95.0|-26.3|-9.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-9.0|-26.3|<0.001
71870289|NCT02349425|143257776|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.169|TWO_SIDED|95.0|-8.6|1.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.6|-8.6|0.169
71870290|NCT02349425|143257776|SUPERIORITY||Mean Difference (Final Values)|-2.4||||0.341|TWO_SIDED|95.0|-7.5|2.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.6|-7.5|0.341
71870291|NCT02349425|143257776|SUPERIORITY||Mean Difference (Final Values)|-2.0||||0.311|TWO_SIDED|95.0|-5.8|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-5.8|0.311
71870292|NCT02349425|143257776|SUPERIORITY||Mean Difference (Final Values)|-3.7||||0.128|TWO_SIDED|95.0|-8.6|1.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.1|-8.6|0.128
71870293|NCT02349425|143257777|SUPERIORITY||Mean Difference (Final Values)|1.2||||0.613|TWO_SIDED|95.0|-3.5|5.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.9|-3.5|0.613
71870294|NCT02349425|143257777|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.743|TWO_SIDED|95.0|-4.3|3.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||3.1|-4.3|.743
71870295|NCT02349425|143257777|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.589|TWO_SIDED|95.0|-4.1|2.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.3|-4.1|0.589
71870296|NCT02349425|143257777|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.205|TWO_SIDED|95.0|-13.2|2.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||2.9|-13.2|0.205
71870297|NCT02349425|143257778|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.0811|TWO_SIDED|95.0|-1.4|0.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.1|-1.4|0.0811
71870298|NCT02349425|143257778|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0097|TWO_SIDED|95.0|-2.2|-0.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.3|-2.2|0.0097
71870299|NCT02349425|143257778|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0025|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.6|-2.6|0.0025
71870300|NCT02349425|143257778|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.005|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.8|0.0050
71870301|NCT02349425|143257779|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.0506|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||0.0|-1.4|0.0506
71870302|NCT02349425|143257779|SUPERIORITY||Mean Difference (Final Values)|-0.9||||0.0447|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-1.7|0.0447
71870303|NCT02349425|143257779|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.0026|TWO_SIDED|95.0|-2.2|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-2.2|0.0026
71870304|NCT02349425|143257779|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.0405|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.0|-2.2|0.0405
71870305|NCT02349425|143257780|SUPERIORITY||Mean Difference (Final Values)|3.84|||<|0.001|TWO_SIDED|95.0|1.88|5.8|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.80|1.88|<0.001
71870306|NCT02349425|143257780|SUPERIORITY||Mean Difference (Final Values)|3.52|||<|0.001|TWO_SIDED|95.0|1.66|5.38|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||5.38|1.66|<0.001
71870307|NCT02349425|143257781|SUPERIORITY||Mean Difference (Final Values)|-10.6||||0.096|TWO_SIDED|95.0|-23.2|1.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||1.9|-23.2|0.096
71870308|NCT02349425|143257781|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.005|TWO_SIDED|95.0|-33.6|-6.3|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-6.3|-33.6|0.005
71870309|NCT02349425|143257781|SUPERIORITY||Mean Difference (Final Values)|-26.1|||<|0.001|TWO_SIDED|95.0|-40.7|-11.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-11.6|-40.7|<0.001
71870310|NCT02349425|143257781|SUPERIORITY||Mean Difference (Final Values)|-33.8|||<|0.001|TWO_SIDED|95.0|-48.4|-19.1|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-19.1|-48.4|<0.001
71870311|NCT02349425|143257782|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.311|TWO_SIDED|95.0|-19.1|6.2|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||6.2|-19.1|0.311
71870312|NCT02349425|143257782|SUPERIORITY||Mean Difference (Final Values)|-7.4||||0.232|TWO_SIDED|95.0|-19.7|4.9|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||4.9|-19.7|0.232
71870313|NCT02349425|143257782|SUPERIORITY||Mean Difference (Final Values)|-15.6||||0.012|TWO_SIDED|95.0|-27.6|-3.6|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-3.6|-27.6|0.012
71870314|NCT02349425|143257782|SUPERIORITY||Mean Difference (Final Values)|-15.4||||0.043|TWO_SIDED|95.0|-30.4|-0.5|||Mixed Models Analysis|Per Protocol, statistical analysis follows a Mixed Model.||||-0.5|-30.4|0.043
71870315|NCT00876928|143257791|SUPERIORITY_OR_OTHER||Percent of patients developing diabetes|10.0||||0.61|TWO_SIDED|95.0|8.0|12.0||A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index|Chi-squared||Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters|Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.||12|8|0.61
71870316|NCT00876928|143257792|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||ANOVA|||The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.||||0.39
71870317|NCT00118755|143257793|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.3883|TWO_SIDED|95.0|0.67|1.17|||Log Rank|||||1.17|0.67|0.3883
71870318|NCT00118755|143257794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.2458|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2458
71870319|NCT00118755|143257795|SUPERIORITY_OR_OTHER||Difference in Response Rate|9.8||||||95.0|0.9|18.7|||||95% Wald asymptotic CI using normal approximation (continuity corrected)|||18.7|0.9|
71870320|NCT00118755|143257796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.6294||95.0|0.66|1.97|||Log Rank|||||1.97|0.66|0.6294
71870321|NCT00686725|143257800|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||Log Rank|||||||0.183
71870322|NCT00686725|143257801|SUPERIORITY_OR_OTHER|||||||0.35||95.0|||||Log Rank|||||||0.35
71870323|NCT00686725|143257804|SUPERIORITY_OR_OTHER|||||||0.648||95.0|||||Log Rank|||||||0.648
71870324|NCT00686725|143257805|SUPERIORITY_OR_OTHER|||||||0.915||95.0|||||Log Rank|||||||0.915
71870325|NCT01143038|143257823|SUPERIORITY_OR_OTHER_LEGACY||Mean|9.2|||||TWO_SIDED|95.0|8.3|10.1|||||Based on the t-distribution|||10.1|8.3|
71870326|NCT01143038|143257823|SUPERIORITY_OR_OTHER_LEGACY||Bootstrap mean|9.1|STANDARD_ERROR_OF_MEAN|0.4|||TWO_SIDED|95.0|8.3|10.0|||||Estimates are based on bootstrap method with 1000 samples with replacement.|Bootstrap analysis||10.0|8.3|
71870327|NCT00955253|143257850|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||between the placebo and guanfacine conditions||||0.013
71870328|NCT00558259|143257852|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.02|0.25|||Regression, Cox|||Dabigatran vs placebo||0.25|0.02|<0.0001
71870329|NCT00558259|143257853|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.08|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|0.03|0.27|||Regression, Cox|||Dabigatran vs placebo||0.27|0.03|<0.0001
71870330|NCT00558259|143257854|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||< 0.0001
71870331|NCT00558259|143257854|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.06|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.|||1.06|0.04|
71870332|NCT00558259|143257854|SUPERIORITY_OR_OTHER||Percentage of participants with events|3.5|||||TWO_SIDED|95.0|2.21|5.17|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.|||5.17|2.21|
71870333|NCT00558259|143257855|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.0004
71870334|NCT00558259|143257855|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.1|||||TWO_SIDED|95.0|0.0|0.82|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.|||0.82|0.00|
71870335|NCT00558259|143257855|SUPERIORITY_OR_OTHER||Percentage of participants with events|2.1|||||TWO_SIDED|95.0|1.16|3.52|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.|||3.52|1.16|
71870336|NCT00558259|143257856|SUPERIORITY_OR_OTHER|||||||0.2428|||||||Fisher Exact|||Dabigatran vs. Placebo||||0.2428
71870337|NCT00558259|143257856|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.54|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.|||0.54|0.00|
71870338|NCT00558259|143257856|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.09|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.|||1.09|0.04|
71870339|NCT00558259|143257857|SUPERIORITY_OR_OTHER|||||||0.4998||||||As the Cox model did not converge due to too few events, hazard ratios are not estimable.|Fisher Exact|||Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.||||0.4998
71870340|NCT00558259|143257857|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.3|||||TWO_SIDED|95.0|0.04|1.05|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.|||1.05|0.04|
71870341|NCT00558259|143257857|SUPERIORITY_OR_OTHER||Percentage of participants with events|0.0|||||TWO_SIDED|95.0|0.0|0.56|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.|||0.56|0.00|
71870342|NCT00558259|143257857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.92|STANDARD_ERROR_OF_MEAN|0.97||0.0013|TWO_SIDED|95.0|1.52|5.6|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.||5.60|1.52|0.0013
71870343|NCT00558259|143257857|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.82|STANDARD_ERROR_OF_MEAN|0.36||0.0027|TWO_SIDED|95.0|1.23|2.68|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated||2.68|1.23|0.0027
71870344|NCT02874924|143257860|EQUIVALENCE|Pilot study, therefore, no power calculation available.|Mean Difference (Net)|-1.81||||0.56|TWO_SIDED|95.0|-8.48|4.86|||t-test, 2 sided|||Null hypothesis||4.86|-8.48|0.56
71913772|NCT01224106|143348128|SUPERIORITY|||||||0.0903|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 105 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0903
71913773|NCT01224106|143348128|SUPERIORITY|||||||0.0434|||||||Mixed Models Analysis|||"Statistical analysis of the t-tau CSF biomarker between Placebo (Parts 1 and 2) and Gantenerumab 225 mg (Parts 1 and 2) treatment arms at Week 104."||||0.0434
71870345|NCT01749904|143257866|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.|||||<|0.01||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol|ANCOVA|||||||<0.01
71870346|NCT01749904|143257867|OTHER|||||||0.005|||||||Chi-squared|||||||0.005
71870347|NCT01749904|143257868|OTHER|||||||0.001|||||||Chi-squared|||||||0.001
71870348|NCT01749904|143257869|OTHER||||||||||||||||||No statistical analysis was performed on these proportions.|||
71870349|NCT02318992|143257905|OTHER|||||||0.157|||||||Chi-squared, Corrected|||||||0.157
71870350|NCT02318992|143257906|OTHER|||||||0.041|||||||Chi-squared, Corrected|||||||0.041
71870351|NCT00552240|143257911|NON_INFERIORITY_OR_EQUIVALENCE|A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).|Difference in proportion of responders|-0.041||||0.7142||95.0|-0.183|0.101|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.||0.101|-0.183|0.7142
71870352|NCT00552240|143257912|NON_INFERIORITY_OR_EQUIVALENCE|Same as for the primary analysis|Difference in proportion of responders|-0.027||||0.6479||95.0|-0.167|0.113|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.113|-0.167|0.6479
71870353|NCT00552240|143257913|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|0.084||||0.1477||95.0|-0.03|0.197|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.197|-0.030|0.1477
71870354|NCT00552240|143257914|NON_INFERIORITY_OR_EQUIVALENCE|Same as for primary analysis|Difference in proportion of responders|-0.067||||0.3703||95.0|-0.215|0.08|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||||0.080|-0.215|0.3703
71870355|NCT00552240|143257915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.666||||0.0314||95.0|0.46|0.964|||Regression, Cox|Controlling for screening viral load and CD4+ categories.||Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine.||0.964|0.460|0.0314
71870356|NCT00552240|143257916|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.628||||0.0172||95.0|0.428|0.921|||Regression, Cox|Controlling for screening viral load and CD4+ categories||"Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values \< 1 indicate faster response in nevirapine."||0.921|0.428|0.0172
71870357|NCT00552240|143257944|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.8||||0.7315||95.0|-8.4|11.9|||ANCOVA|Controlling for screening viral load and CD4+ categories||||11.9|-8.4|0.7315
71870358|NCT00552240|143257945|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-10.6||||0.3625||95.0|-33.4|12.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||12.3|-33.4|0.3625
71870359|NCT00552240|143257946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.8||||0.0164||95.0|0.9|8.8|||ANCOVA|Controlling for screening viral load and CD4+ categories||||8.8|0.9|0.0164
71870360|NCT00552240|143257947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.9257||95.0|-8.4|9.3|||ANCOVA|Controlling for screening viral load and CD4+ categories||||9.3|-8.4|0.9257
71870361|NCT00552240|143257948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0375||95.0|-0.64|-0.02|||ANCOVA|Controlling for screening viral load and CD4+ categories||||-0.02|-0.64|0.0375
71870362|NCT00552240|143257949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.4645||95.0|-1.02|0.47|||ANCOVA|Controlling for screening viral load and CD4+ categories||||0.47|-1.02|0.4645
71870363|NCT02783768|143257959|OTHER|Testing for difference in the outcome measure according to the exposure (which was not a treatment) in a randomized crossover setting.|Mean Difference (Net)|13.98||||0.012|TWO_SIDED|95.0|4.012|23.94|||Mixed Models Analysis||Measurements were included for participants with at least one valid MRI measurement.|"Within-person effects of e-cigarette exposure on pulmonary microvascular blood flow (PMBF) was assessed via mixed models accounting for order effects.~Null hypothesis: e-cigarette exposure is NOT associated with a change in PMBF.~Alternative hypothesis: e-cigarette exposure IS associated with a change in PMBF.~Power calculation: not applicable since this was a pilot/feasibility study."||23.94|4.012|0.012
71870364|NCT02054741|143258000|SUPERIORITY||Risk Ratio (RR)|0.74||||0.0001|TWO_SIDED|95.0|0.64|0.86|||Mixed Models Analysis|Generalized Linear Mixed Model||||0.86|0.64|0.0001
71870365|NCT02054741|143258001|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.39|TWO_SIDED|95.0|0.85|1.5|||Regression, Cox|||||1.50|0.85|0.39
71870366|NCT02054741|143258002|SUPERIORITY||Risk Ratio (RR)|1.38||||0.015|TWO_SIDED|95.0|1.06|1.78|||Mixed Models Analysis|Generalized Linear Mixed Model||||1.78|1.06|0.015
71870367|NCT02319525|143258034|SUPERIORITY_OR_OTHER|||||||0.005|||||||t-test, 2 sided|||||||0.005
71870368|NCT02319525|143258035|SUPERIORITY_OR_OTHER|||||||0.08||||||We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.|Chi-squared|||||||0.08
71913774|NCT00446797|143348147|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than -10 mm.|Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|2.11||||95.0|-0.76|7.55|||ANCOVA|Terms for treatment, country (fixed), and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Least squares mean||7.55|-0.76|
71913775|NCT00446797|143348148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-0.89|7.08|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||7.08|-0.89|
71870369|NCT02319525|143258036|SUPERIORITY_OR_OTHER|||||||0.252|||||||Chi-squared|||We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.||||0.252
71870370|NCT02319525|143258037|SUPERIORITY_OR_OTHER|||||||0.504|||||||t-test, 2 sided|||||||0.504
71870371|NCT02319525|143258038|SUPERIORITY_OR_OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71870372|NCT02319525|143258039|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Impact of lupus nephritis"||||0.006
71870373|NCT02319525|143258039|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Risk factors"||||0.006
71870374|NCT02319525|143258039|SUPERIORITY_OR_OTHER|||||||0.003|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the medication options"||||0.003
71870375|NCT02319525|143258039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the evidence about medications"||||<0.001
71870376|NCT02319525|143258039|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the study about other patients"||||<0.001
71870377|NCT02319525|143258040|SUPERIORITY_OR_OTHER|||||||0.006|||||||Chi-squared|||The test of significance compared all the rows, i.e., all response options for the statement.||||0.006
71870378|NCT00598273|143258068|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.099|||TWO_SIDED|97.5|-0.19|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.26|-0.19|
71870379|NCT00598273|143258068|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|0.098|||TWO_SIDED|97.5|0.04|0.48|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.48|0.04|
71870380|NCT00598273|143258069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.51|3.1|||Cochran-Mantel-Haenszel|||||3.10|0.51|
71870381|NCT00598273|143258069|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.48|||||TWO_SIDED|95.0|0.62|3.56|||Cochran-Mantel-Haenszel|||||3.56|0.62|
71870382|NCT00598273|143258070|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.94|1.05|||Cochran-Mantel-Haenszel|||||1.05|0.94|
71870383|NCT00598273|143258070|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.95|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.95|
71870384|NCT03218397|143258135|SUPERIORITY||Difference in means|5.6||||0.013|TWO_SIDED|95.0|1.2|10.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||10|1.2|0.013
71870385|NCT03218397|143258136|SUPERIORITY|||||||0.265||||||alpha = 0.05|Fisher Exact|||||||0.265
71870386|NCT03218397|143258137|SUPERIORITY|||||||0.093||||||alpha = 0.05|t-test, 2 sided|T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.||||||0.093
71870387|NCT03218397|143258138|SUPERIORITY|||||||0.014||||||alpha = 0.05|Fisher Exact|||||||0.014
71870388|NCT03218397|143258139|SUPERIORITY||Difference in means|7.5||||0.009|TWO_SIDED|95.0|1.9|13.1||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||13.1|1.9|0.009
71870389|NCT03218397|143258140|SUPERIORITY||Difference in means|6.5||||0.022|TWO_SIDED|95.0|0.9|12.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||12.0|0.9|0.022
71870390|NCT03218397|143258141|SUPERIORITY||Difference in means|0.7||||0.46|TWO_SIDED|95.0|-1.2|2.7||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.7|-1.2|0.46
71870391|NCT03218397|143258142|SUPERIORITY||Difference in means|4.6||||0.074|TWO_SIDED|95.0|-0.4|9.6||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||9.6|-0.4|0.074
71870392|NCT03218397|143258143|SUPERIORITY||Difference in means|6.5||||0.008|TWO_SIDED|95.0|1.7|11.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||11.2|1.7|0.008
71870393|NCT03218397|143258144|SUPERIORITY||Difference in means|-1.9||||0.37|TWO_SIDED|95.0|-5.9|2.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)|||2.2|-5.9|0.37
71870394|NCT00943111|143258147|NON_INFERIORITY_OR_EQUIVALENCE|The sample size for study was based on expected stability rates of 95% for the Imiglucerase group and 85% for the Eliglustat group, power of 85%, a one-sided significance level of 0.025, a non-inferiority margin of 25%, and a 20% non-evaluable/drop-out rate. Eliglustat was declared non-inferior to Imiglucerase if the lower-bound of the 95% confidence interval for the difference was within the non-inferiority margin of 25%.|Difference in Percentage Stable|-8.8|||||TWO_SIDED|95.0|-17.6|4.2||||||||4.2|-17.6|
71870395|NCT00112047|143258187|NON_INFERIORITY_OR_EQUIVALENCE|Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.4||||0.002|TWO_SIDED|95.0|4.3|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||18.6|4.3|0.002
71870396|NCT00112047|143258188|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|9.1||||0.021|TWO_SIDED|95.0|1.6|16.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||16.6|1.6|0.021
71870397|NCT00112047|143258189|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|11.2||||0.004|TWO_SIDED|95.0|3.7|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made||Null hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||18.6|3.7|0.004
71870398|NCT00112047|143258190|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|7.9||||0.058|TWO_SIDED|95.0|0.1|15.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||15.6|0.1|0.058
71870399|NCT00112047|143258191|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.003
71870400|NCT00112047|143258192|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.||||0.046
71913776|NCT00446797|143348148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.46|STANDARD_ERROR_OF_MEAN|2.04||||95.0|-0.55|7.48|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||7.48|-0.55|
71913777|NCT00446797|143348148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.76|STANDARD_ERROR_OF_MEAN|1.86||||95.0|-0.91|6.42|||ANCOVA|Terms for treatment, country (fixed) and the baseline pain VAS score|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||6.42|-0.91|
71913778|NCT00446797|143348149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1591||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 2||||0.1591
71870401|NCT00112047|143258193|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 48 is different between the 2 treatment groups.||||0.026
71870402|NCT00112047|143258194|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.||||0.063
71870403|NCT00112047|143258195|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.31|TWO_SIDED|95.0|-0.16|0.06||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.06|-0.16|0.31
71870404|NCT00112047|143258196|SUPERIORITY_OR_OTHER||stratum-weighted difference|31.74||||0.002||95.0|8.96|54.52||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||54.52|8.96|0.002
71870405|NCT00112047|143258197|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in percentages|12.7||||0.004|TWO_SIDED|95.0|4.3|21.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.1|4.3|0.004
71870406|NCT00112047|143258198|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|6.4||||0.158|TWO_SIDED|95.0|-2.3|15.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||15.0|-2.3|0.158
71870407|NCT00112047|143258199|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
71870408|NCT00112047|143258200|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.124
71870409|NCT00112047|143258201|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 96 is different between the 2 treatment groups.||||0.025
71870410|NCT00112047|143258202|SUPERIORITY_OR_OTHER|||||||0.41||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA \< 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.41
71870411|NCT00112047|143258203|SUPERIORITY_OR_OTHER||stratum-weighted difference|-0.05||||0.45||95.0|-0.17|0.08||The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.17|0.45
71870412|NCT00112047|143258204|SUPERIORITY_OR_OTHER||stratum-weighted difference|32.93||||0.036||95.0|0.87|64.99||The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||64.99|0.87|0.036
71870413|NCT00112047|143258205|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum Test|No other adjustments were made.||Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal||||<0.001
71870414|NCT00112047|143258206|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.025
71870415|NCT00112047|143258207|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
71870416|NCT00112047|143258208|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|12.9||||0.004|TWO_SIDED|95.0|4.2|21.6||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 400 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||21.6|4.2|0.004
71870417|NCT00112047|143258209|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|8.1||||0.082|TWO_SIDED|95.0|-0.8|17.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA \< 50 c/mL \[defined by the TLOVR algorithm\]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."||17.0|-0.8|0.082
71870418|NCT00112047|143258210|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|11.6||||0.009||95.0|3.1|20.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null Hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||20.1|3.1|0.009
71883062|NCT00385255|143285393|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the filamentous hemagglutinin (FHA) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.71|||||TWO_SIDED|95.0|0.64|0.79|||ANCOVA|||Difference in adjusted GMC ratio for anti-FHA antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.||0.79|0.64|
71870419|NCT00112047|143258211|NON_INFERIORITY_OR_EQUIVALENCE|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was \> -0.13.|Difference in proportions|10.4||||0.019|TWO_SIDED|95.0|1.8|19.0||The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA \< 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.||19.0|1.8|0.019
71870420|NCT00112047|143258212|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.003
71870421|NCT00112047|143258213|SUPERIORITY_OR_OTHER|||||||0.056||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA \< 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different||||0.056
71870422|NCT00112047|143258214|SUPERIORITY_OR_OTHER|||||||0.066||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 400 c/mL) at Week 144 is different between the 2 treatment groups||||0.066
71870423|NCT00112047|143258215|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA \< 50 c/mL) at Week 144 is different between the 2 treatment groups||||0.30
71870424|NCT00112047|143258216|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.16|0.08||The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.||0.08|-0.16|0.39
71870425|NCT00112047|143258217|SUPERIORITY_OR_OTHER||Mean Difference (Net)|41.3||||0.089|TWO_SIDED|95.0|4.05|78.55||The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.||78.55|4.05|0.089
71870426|NCT00112047|143258218|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.001
71870427|NCT00112047|143258219|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||0.011
71870428|NCT00112047|143258220|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different||||<0.001
71870429|NCT00112047|143258230|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.||||0.16
71913779|NCT00446797|143348149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3995||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 3||||0.3995
71913780|NCT00446797|143348149|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6805||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 7||||0.6805
71913781|NCT00446797|143348150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2411||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.2411
71870430|NCT00112047|143258231|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.||||0.049
71870431|NCT00112047|143258232|SUPERIORITY_OR_OTHER|||||||0.055||95.0||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.||||0.055
71913782|NCT00446797|143348150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1163||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.1163
71913783|NCT00446797|143348150|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.0440
71913784|NCT00446797|143348151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7223||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.7223
71913785|NCT00446797|143348151|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0541||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.0541
71913786|NCT00446797|143348152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 2||||0.2900
71913787|NCT00446797|143348152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0157||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3||||0.0157
71913788|NCT00446797|143348152|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1206||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7||||0.1206
71913789|NCT00446797|143348153|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0846||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2||||0.0846
71913790|NCT00446797|143348153|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3041||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3||||0.3041
71913791|NCT00446797|143348153|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1216||95.0||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7||||0.1216
71913792|NCT00446797|143348154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.24||0.395||95.0|-0.33|0.62||Overall p-value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.33|0.395
71913793|NCT00446797|143348154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.61|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|0.18|1.04||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.04|0.18|0.004
71913794|NCT00446797|143348154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.22||0.122||95.0|-0.08|0.77||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.77|-0.08|0.122
71913795|NCT00446797|143348155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.604||95.0|-0.32|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.49|-0.32|0.604
71913796|NCT00446797|143348155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.28|STANDARD_DEVIATION|0.18||0.124||95.0|-0.07|0.63||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.63|-0.07|0.124
71913797|NCT00446797|143348155|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.15||0.062||95.0|0.03|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|0.03|0.062
71913798|NCT00446797|143348156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.21||0.705||95.0|-0.36|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.47|-0.36|0.705
71913799|NCT00446797|143348156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.19||0.064||95.0|-0.01|0.73||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.73|-0.01|0.064
71913800|NCT00446797|143348156|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.17||0.074||95.0|-0.01|0.68||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.68|-0.01|0.074
71913801|NCT00446797|143348157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.24||0.017||95.0|0.11|1.05||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||1.05|0.11|0.017
71870432|NCT00112047|143258233|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||<0.001
71870433|NCT00112047|143258234|SUPERIORITY_OR_OTHER|||||||0.12||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.12
71870434|NCT00112047|143258235|SUPERIORITY_OR_OTHER|||||||0.037||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.037
71913802|NCT00446797|143348157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.2||0.108||95.0|-0.05|0.74||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.74|-0.05|0.108
71913803|NCT00446797|143348157|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.17||0.117||95.0|-0.01|0.66||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.66|-0.01|0.117
71913804|NCT00446797|143348158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.2||0.229||95.0|-0.17|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.17|0.229
71913805|NCT00446797|143348158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.18||0.027||95.0|0.05|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.75|0.05|0.027
71913806|NCT00446797|143348158|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.16||0.07||95.0|0.01|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.65|0.01|0.070
71913807|NCT00446797|143348159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3||0.954||95.0|-0.64|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.53|-0.64|0.954
71913808|NCT00446797|143348159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.41|STANDARD_ERROR_OF_MEAN|0.31||0.172||95.0|-0.19|1.02||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||1.02|-0.19|0.172
71683173|NCT05727306|142884372|OTHER||Incidence rate ratio (IRR)|1.42|||||TWO_SIDED|95.0|1.37|1.46|||||Calculated as the incidence rate of attending primary care in participants diagnosed of Alopecia Areata vs. participants without Alopecia Areata. Incidence rate ratio adjusted for sociodemographic, clinical characteristics and major comorbidities.|||1.46|1.37|
71913809|NCT00446797|143348159|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.24||0.541||95.0|-0.3|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.62|-0.30|0.541
71913810|NCT00446797|143348160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.34||0.924||95.0|-0.75|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.58|-0.75|0.924
71913811|NCT00446797|143348160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.29||0.898||95.0|-0.62|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.62|0.898
71913812|NCT00446797|143348160|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.24||0.655||95.0|-0.33|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.60|-0.33|0.655
71913813|NCT00446797|143348161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.31||0.929||95.0|-0.59|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.62|-0.59|0.929
71870435|NCT00112047|143258236|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.013
71870436|NCT00112047|143258237|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||"The number and proportion of participants in each category (bothers, does not bother) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.70
71870437|NCT00112047|143258238|SUPERIORITY_OR_OTHER|||||||0.95||95.0||||P-value is from the Wilcoxon Signed Rank Test.|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.95
71870438|NCT00112047|143258239|SUPERIORITY_OR_OTHER|||||||0.23||95.0||||P-value is from the Wilcoxon Signed Rank Test|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).||||0.23
71870439|NCT00910689|143258267|SUPERIORITY_OR_OTHER||||||<|0.01||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family-wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus Test: A mixed model with fixed effects for treatment,natural time(defined as natural log of months) and treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects(using the PROC MIXED procedure in SAS statistical software,version 9;www.sas.com). A significant treatment by time interaction(p \< .05, 2-tailed) was followed by post-tests (see below). Details of significant post tests are reported as separate analyses.||||< .01
71870440|NCT00910689|143258267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_DEVIATION|0.57|<|0.001||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870441|NCT00910689|143258267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.68|>|0.25|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .25
71870442|NCT00910689|143258267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.59|>|0.98|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .98
71870443|NCT00910689|143258267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870444|NCT00910689|143258267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.61|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
71870445|NCT00910689|143258267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.72|>|0.29|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.29
71913814|NCT00446797|143348161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.3||0.712||95.0|-0.5|0.71||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.71|-0.50|0.712
71870446|NCT00910689|143258268|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|95.0||||6 pair wise contrasts were conducted: The first 3 contrasts compared each of the 3 additive treatments to OAT + PL. The 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (PROC MIXED, SAS 9).When the treatment by time interaction was significant (p \< .05, 2-tailed)post-tests were conducted (see below).Details of significant post tests are reported as separate analyses.||||< .03
71870447|NCT00910689|143258268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870448|NCT00910689|143258268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|1.12|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870449|NCT00910689|143258268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.1|STANDARD_DEVIATION|1.26|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870450|NCT00910689|143258268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.2|>|0.02|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .02
71870451|NCT00910689|143258268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|1.35|>|0.79||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>.79
71913815|NCT00446797|143348161|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.993||95.0|-0.44|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.51|-0.44|0.993
71870452|NCT00910689|143258268|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.43|>|0.02||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|||Post-test contrast. Mean difference in change.||||>.02
71870453|NCT00910689|143258269|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED|95.0||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); three additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure controlled the familywise type I error for the 6 contrasts at .05. Adjusted p=.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction and pretreatment Migraine Specific Quality of Life scores as covariate was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (using the PROC MIXED procedure in SAS statistical software, version 9; www. sas.com).A significant treatment by time interaction (p \< .05, 2-tailed) was followed by post-tests||||<.005
71870454|NCT00910689|143258269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|STANDARD_DEVIATION|2.18|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||< .001
71870455|NCT00910689|143258269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.0|STANDARD_DEVIATION|2.41|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870456|NCT00910689|143258269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4|STANDARD_DEVIATION|1.67|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||< .001
71870457|NCT00910689|143258269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.9|STANDARD_DEVIATION|2.03|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
71870458|NCT00910689|143258269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|1.83|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870459|NCT00910689|143258269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|2.38|>|0.87||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.87
71870460|NCT00910689|143258270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.77|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
71870461|NCT00910689|143258270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.79|>|0.83|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .83
71870462|NCT00910689|143258270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.67|>|0.05|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||> .05
71913816|NCT00446797|143348162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.32||0.779||95.0|-0.53|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.75|-0.53|0.779
71870463|NCT00910689|143258270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|0.86|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Significant post-test contrast. Mean difference in change.||||< .001
71870464|NCT00910689|143258270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_DEVIATION|0.95|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
71870465|NCT00910689|143258270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|0.89|>|0.2|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||> .20
71870466|NCT00910689|143258271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2|STANDARD_DEVIATION|1.7|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||<.001
71870467|NCT00910689|143258271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6|STANDARD_DEVIATION|1.96|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.||||<.001
71870468|NCT00910689|143258271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0|STANDARD_DEVIATION|1.69|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870469|NCT00910689|143258271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_DEVIATION|1.69|>|0.04||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>.04
71870470|NCT00910689|143258271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.34|>|0.33||95.0||||Bonerfoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.33
71870471|NCT00910689|143258271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|1.68|>|0.21||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.21
71870472|NCT00910689|143258272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.4|STANDARD_DEVIATION|3.0|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71913817|NCT00446797|143348162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.972||95.0|-0.69|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.65|-0.69|0.972
71870473|NCT00910689|143258272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|3.29|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71913818|NCT00446797|143348162|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.27||0.844||95.0|-0.47|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.61|-0.47|0.844
71913819|NCT00446797|143348163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.31||0.944||95.0|-0.63|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.60|-0.63|0.944
71913820|NCT00446797|143348163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.26||0.654||95.0|-0.62|0.38||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.38|-0.62|0.654
71913821|NCT00446797|143348163|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.19||0.952||95.0|-0.36|0.39||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.39|-0.36|0.952
71913822|NCT00446797|143348164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.31||0.842||95.0|-0.65|0.59||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.59|-0.65|0.842
71870474|NCT00910689|143258272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_DEVIATION|2.99|<|0.001|TWO_SIDED|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.||||< .001
71870475|NCT00910689|143258272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_DEVIATION|2.85|>|0.56||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.56
71870476|NCT00910689|143258272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_DEVIATION|2.45|>|0.08||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.||||>0.08
71870477|NCT00910689|143258272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1|STANDARD_DEVIATION|2.83|>|0.03||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.||||>0.03
71870478|NCT00189488|143258273|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-17.9||||0.034|TWO_SIDED|95.0|-33.4|-2.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||-2.4|-33.4|0.034
71870479|NCT00189488|143258274|SUPERIORITY_OR_OTHER||Adjusted Difference (%)|0.5||||0.929|TWO_SIDED|95.0|-11.0|12.1|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with severe GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||12.1|-11.0|0.929
71870480|NCT00189488|143258275|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-6.5||||0.352|TWO_SIDED|95.0|-19.4|6.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Day 11 Methotrexate GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||6.4|-19.4|0.352
71870481|NCT00189488|143258276|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|-2.6||||0.675|TWO_SIDED|95.0|-14.2|9.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with severe oral mucositis, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|"Participants with Unknown incidence are treated as Yes when constructing the differences, 95% confidence intervals and p-value."||9.0|-14.2|0.675
71870482|NCT00189488|143258277|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|0.5||||0.953|TWO_SIDED|95.0|-1.5|2.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||2.5|-1.5|0.953
71870483|NCT00189488|143258278|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference (%)|2.0||||0.797|TWO_SIDED|95.0|-12.5|16.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with opioid analgesic use, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||16.5|-12.5|0.797
71913823|NCT00446797|143348164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.27||0.828||95.0|-0.57|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.49|-0.57|0.828
71913824|NCT00446797|143348164|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.21||0.542||95.0|-0.3|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.53|-0.30|0.542
71913825|NCT00446797|143348165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.34||0.404||95.0|-0.92|0.42||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.42|-0.92|0.404
71913826|NCT00446797|143348165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.28||0.816||95.0|-0.53|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.58|-0.53|0.816
71870484|NCT00189488|143258279|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-5.5||||0.186|TWO_SIDED|95.0|-12.7|1.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||1.8|-12.7|0.186
71913827|NCT00446797|143348165|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.837||95.0|-0.37|0.52||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.52|-0.37|0.837
71913828|NCT00446797|143348166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.25||0.887||95.0|-0.54|0.45||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean||0.45|-0.54|0.887
71913829|NCT00446797|143348166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.24||0.889||95.0|-0.43|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean||0.51|-0.43|0.889
71913830|NCT00446797|143348166|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.2||0.738||95.0|-0.3|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean||0.47|-0.30|0.738
71913831|NCT02498392|143348193|SUPERIORITY||Difference of Least Square (LS) Means|-0.2|STANDARD_ERROR_OF_MEAN|1.04|=|0.416|TWO_SIDED|60.0|-1.1|0.66|||Mixed-effects Model for Repeated Measure|||||0.66|-1.10|= 0.416
71870485|NCT00189488|143258280|SUPERIORITY_OR_OTHER||Adjusted Treatment Difference|-4.1||||0.219|TWO_SIDED|5.0|-12.2|4.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|||4.0|-12.2|0.219
71870486|NCT00192647|143258284|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2893|TWO_SIDED|95.0|0.88|1.52|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by viral load and country||||1.52|0.88|0.2893
71913832|NCT02498392|143348194|SUPERIORITY||Difference of Least Square (LS) Means|0.3|STANDARD_ERROR_OF_MEAN|0.88|=|0.647|TWO_SIDED|60.0|-0.41|1.07||1-sided|Mixed-effects Model for Repeated Measure|||||1.07|-0.41|= 0.647
71870487|NCT00192647|143258285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.91|1.63||||||||1.63|0.91|
71870488|NCT00192647|143258286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||||TWO_SIDED|95.0|1.24|2.27||||||Week 4||2.27|1.24|
71870489|NCT00192647|143258286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.24|2.17||||||Week 8||2.17|1.24|
71870490|NCT00192647|143258286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.4|2.53||||||Week 12||2.53|1.40|
71870491|NCT00192647|143258286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|1.08|1.98||||||Week 24||1.98|1.08|
71870492|NCT01828073|143258292|OTHER||Clopper-Pearson Confidence Interval (CI)|31.82|||||TWO_SIDED|90.0|16.0|51.5|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)||51.50|16.00|
71870493|NCT01828073|143258292|OTHER||Clopper-Pearson Confidence Interval (CI)|50.0|||||TWO_SIDED|90.0|29.1|70.9|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)||70.90|29.10|
71870494|NCT01828073|143258296|OTHER|||||||0.747||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.||||0.747
71870495|NCT01828073|143258296|OTHER|||||||0.341||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.||||0.341
71870496|NCT02915302|143258297|NON_INFERIORITY|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was \<5%.|Difference in Fever Rate|0.84|||||TWO_SIDED|95.0|-2.13|3.8|||||Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)|Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.||3.80|-2.13|
71870497|NCT02915302|143258298|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H1N1)|1.45|||||TWO_SIDED|95.0|1.19|1.77|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.77|1.19|
71870498|NCT02915302|143258298|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (A/H3N2)|1.5|||||TWO_SIDED|95.0|1.23|1.83|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.83|1.23|
71870499|NCT02915302|143258298|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Victoria lineage)|1.33|||||TWO_SIDED|95.0|1.1|1.62|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.62|1.10|
71870500|NCT02915302|143258298|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was \>0.667.|GMTs Ratio (B Yamagata lineage)|1.44|||||TWO_SIDED|95.0|1.2|1.73|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.||1.73|1.20|
71913833|NCT00356057|143348247|SUPERIORITY|||||||0.437|||||||t-test, 2 sided|||||||0.437
71913834|NCT00356057|143348247|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
71913835|NCT00356057|143348248|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0596|||||||t-test, 1 sided|||||||0.0596
71913836|NCT00356057|143348249|EQUIVALENCE|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0009|||||||t-test, 1 sided|||||||0.0009
71913837|NCT00356057|143348252|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
71913838|NCT00356057|143348252|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71913839|NCT00356057|143348256|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71913840|NCT00356057|143348256|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71913841|NCT00356057|143348257|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
71913842|NCT00356057|143348257|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|||||||0.008
71913843|NCT00356057|143348258|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71913844|NCT00356057|143348258|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71913845|NCT00356057|143348259|SUPERIORITY|||||||0.039|||||||t-test, 2 sided|||||||0.039
71913846|NCT00356057|143348259|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71913847|NCT01451398|143348260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.57|-0.23|||Mixed Models Analysis|Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment\*Visit), using AR(1) variance/covariance structure.||||-0.23|-0.57|<0.0001
71913848|NCT01451398|143348261|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.726||||0.0005|TWO_SIDED|95.0|1.55|4.8|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||4.80|1.55|0.0005
71913849|NCT01451398|143348262|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.361||||0.0021|TWO_SIDED|95.0|1.7|11.17|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c||||11.17|1.70|0.0021
71913850|NCT01451398|143348263|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.42|STANDARD_ERROR_OF_MEAN|5.4||0.1698|TWO_SIDED|95.0|-18.03|3.18|||Mixed Models Analysis|"Model: FPG = Baseline FPG + Region + Pooled OAD Stratum + Visit + Treatment + (Treatment \* Visit)~Variance/Covariance Matrix is Autoregression 1"||||3.18|-18.03|0.1698
71913851|NCT01451398|143348266|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.018|||TWO_SIDED|95.0|-0.12|-0.05|||Mixed Models Analysis|FEV1 = Baseline FEV1 + Age + Gender + Race + Height + Visit + Treatment + (Treatment\*Visit)||||-0.05|-0.12|
71913852|NCT01451398|143348269|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative binomial regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||<0.0001
71913853|NCT01451398|143348270|SUPERIORITY_OR_OTHER|||||||0.2024|||||||Negative Binomial Regression|Model: Treatment + Region + OAD Stratum + Exposure Time||||||0.2024
71913854|NCT01451398|143348273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62|STANDARD_ERROR_OF_MEAN|0.365|<|0.0001|TWO_SIDED|95.0|0.9|2.34|||ANCOVA||Model: Baseline Weight + Change in HbA1c at Week 24 + Region + OAD Stratum + Treatment|||2.34|0.90|<0.0001
71913855|NCT02120352|143348304|OTHER||Difference in Percentage|3.7|||||TWO_SIDED|95.0|-4.8|12.2|||||Comparison between CAB LA 600 mg+RPV LA 900 mg IM-Q8W and CAB 30 mg+ABC/3TC QD|||12.2|-4.8|
71913856|NCT02120352|143348304|OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-5.8|11.5|||||Comparison between CAB LA 400 mg+RPV LA 600 mg IM-Q4W and CAB 30 mg+ABC/3TC QD|||11.5|-5.8|
71913857|NCT02427100|143348369|SUPERIORITY_OR_OTHER|||||||0.18|||||||ANCOVA|||||||.18
71913858|NCT02427100|143348370|SUPERIORITY_OR_OTHER|||||||0.00036||||||The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.|Mixed Models Analysis|A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.||||||.00036
71913859|NCT00444964|143348371|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71913860|NCT00444964|143348372|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71913861|NCT00444964|143348373|OTHER||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71913862|NCT02573233|143348386|SUPERIORITY|||||||0.84||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.8400
71913863|NCT02573233|143348387|SUPERIORITY||LS Mean Difference|-235.02||||0.0336|TWO_SIDED|90.0|-414.19|-55.84||Threshold for significance at 0.05 level|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||-55.84|-414.19|0.0336
71913864|NCT02573233|143348388|SUPERIORITY||LS mean difference|13.89||||0.4795|TWO_SIDED|90.0|-19.0|46.78||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||46.78|-19.00|0.4795
71913865|NCT02573233|143348389|SUPERIORITY||LS mean difference|-18.98||||0.4494|TWO_SIDED|90.0|-60.92|22.97||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.||22.97|-60.92|0.4494
71913866|NCT02573233|143348390|SUPERIORITY|||||||0.6865||||||Threshold for significance at 0.05 level.|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.6865
71913867|NCT02573233|143348391|SUPERIORITY|||||||0.7588||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.||||0.7588
71913868|NCT02573233|143348392|SUPERIORITY||LS Mean Difference|-22.4||||0.0012|TWO_SIDED|90.0|-32.9|-11.9||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect Model with Repeated Measures (MRMM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-11.9|-32.9|0.0012
71913869|NCT02573233|143348393|SUPERIORITY||LS Mean Difference|-22.0||||0.0005|TWO_SIDED|90.0|-31.3|-12.8||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect model with Repeated Measures (MMRM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.||-12.8|-31.3|0.0005
71913870|NCT05103475|143348407|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's exact due to small cell sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||||||1.0
71913871|NCT05103475|143348408|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.35|||||||t-test, 2 sided|||||||0.35
71913872|NCT05103475|143348409|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||||||0.15
71913873|NCT05103475|143348410|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.43|||||||t-test, 2 sided|||Pre/post comparison for control group scores.||||0.43
71913874|NCT05103475|143348410|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.24|||||||t-test, 2 sided|||Pre/post comparison for RAP group score.||||0.24
71913875|NCT05103475|143348410|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.53||||||F = 0.41|ANOVA|||ANOVA results - group x time interaction.||||0.53
71913876|NCT05103475|143348411|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.7|||||||t-test, 2 sided|||Pre/post comparison for control group.||||0.70
71913877|NCT05103475|143348411|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.17|||||||t-test, 2 sided|||Pre/post comparison for RAP group.||||0.17
71870501|NCT02915302|143258299|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H1N1)|5.1|||||TWO_SIDED|95.0|0.189|10.0|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||10.0|0.189|
71913878|NCT05103475|143348411|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.18||||||F = 1.95|ANOVA|||ANOVA results - group x time interaction.||||0.18
71913879|NCT05103475|143348412|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.37|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.37
71913880|NCT05103475|143348412|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.50
71913881|NCT05103475|143348412|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.9||||||F = 0.01|ANOVA|||ANOVA results - group x time interaction.||||0.90
71913882|NCT05103475|143348413|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.56|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.56
71913883|NCT05103475|143348413|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.32|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.32
71913884|NCT05103475|143348413|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41||||||F = 0.71|ANOVA|||ANOVA results - group x time interaction.||||0.41
71913885|NCT05103475|143348414|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.5|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.50
71913886|NCT05103475|143348414|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.6|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.60
71913887|NCT05103475|143348414|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.98||||||F = 0.0|ANOVA|||ANOVA results - group x time interaction.||||0.98
71913888|NCT05103475|143348415|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.54|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.54
71913889|NCT05103475|143348415|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.15|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.15
71913890|NCT05103475|143348415|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.04||||||F = 4.9|ANOVA|||ANOVA results - group x time interaction.||||0.04
71913891|NCT05103475|143348416|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.11|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.11
71913892|NCT05103475|143348416|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.09|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.09
71913893|NCT05103475|143348416|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.75||||||F = 0.10|ANOVA|||ANOVA results - group x time interaction.||||0.75
71870502|NCT02915302|143258299|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (A/H3N2)|4.3|||||TWO_SIDED|95.0|-0.283|8.99|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||8.99|-0.283|
71913894|NCT05103475|143348417|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.41|||||||Fisher Exact|The investigators used Fisher's Exact due to small cell sizes.||Likelihood to participate in a program like it in the future||||0.41
71913895|NCT05103475|143348417|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.003||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Help to manage back pain.||||0.003
71913896|NCT05103475|143348417|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||1||||||The investigators used Fisher's Exact due to small sample sizes.|Fisher Exact|The reported value represents the calculated p-value for the Fisher's Exact test.||Would recommend to another Veteran.||||1.00
71913897|NCT05103475|143348417|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.07||||||The investigators used Fisher's Exact due to small cell sizes.|Fisher Exact|||Liked the program.||||0.07
71913898|NCT05103475|143348418|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.91|||||||t-test, 2 sided|||Pre/post comparison - control group.||||0.91
71913899|NCT05103475|143348418|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.51|||||||t-test, 2 sided|||Pre/post comparison - RAP group.||||0.51
71913900|NCT05103475|143348418|OTHER|Please note that all data analyses were exploratory because this was feasibility pilot.||||||0.42||||||F = 0.68|ANOVA|||ANOVA results - group x time interaction.||||0.42
71913901|NCT00924729|143348419|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71913902|NCT02917629|143348465|SUPERIORITY||Mean Difference (Final Values)|1.0011|STANDARD_DEVIATION|0.024||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000229822 baseline and post exposure||||0.031
71913903|NCT02917629|143348465|SUPERIORITY||Mean Difference (Final Values)|-1.0217|STANDARD_DEVIATION|0.0257||0.031|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000230585 baseline and post exposure||||0.031
71913904|NCT02917629|143348465|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post exposure||||<0.001
71913905|NCT02917629|143348465|SUPERIORITY||Mean Difference (Final Values)|1.0007|STANDARD_DEVIATION|0.0063|<|0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000261792 baseline and post exposure||||<0.001
71913906|NCT02917629|143348466|SUPERIORITY||Mean Difference (Final Values)|1.006|STANDARD_DEVIATION|0.006||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000234806 baseline and post exposure||||0.002
71913907|NCT02917629|143348467|SUPERIORITY||Mean Difference (Final Values)|1.0013|STANDARD_DEVIATION|0.0072||0.002|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000232479 baseline and post exposure||||0.002
71913908|NCT02917629|143348467|SUPERIORITY||Mean Difference (Final Values)|1.0037|STANDARD_DEVIATION|0.0193||0.02|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000233163 baseline and post exposure||||0.020
71913909|NCT02917629|143348467|SUPERIORITY||Mean Difference (Final Values)|-1.0098|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||Benjamini and Hochberg|||ENSG00000249245 baseline and post-exposure||||0.001
71913910|NCT01042938|143348496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7991|STANDARD_DEVIATION|0.7606||0.0077|TWO_SIDED|95.0|-1.3693|-0.2289|||Standard pooled variances t-test|||Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.||-0.2289|-1.3693|0.0077
71913911|NCT01042938|143348497|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Fisher Exact|||Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.||||0.0022
71913912|NCT01042938|143348498|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||ANOVA|||Hypothesis: There is a significant difference in mean redness (i.e., mean a\* number value) between the curcumin and placebo groups.||||0.145
71913913|NCT01042938|143348499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.685||||0.218|TWO_SIDED|95.0|-1.059|4.428|||ANCOVA|||Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.||4.428|-1.059|0.218
71913914|NCT01042938|143348499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.152|TWO_SIDED|95.0|-0.6|3.6|||ANCOVA|||Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.||3.6|-0.6|0.152
71913915|NCT01042938|143348499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.7|TWO_SIDED|95.0|-0.7|1.1|||ANCOVA|||Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.||1.1|-0.7|0.700
71913916|NCT01042938|143348499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.559|TWO_SIDED|95.0|-0.4|0.7|||ANCOVA|||Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.||0.7|-0.4|0.559
71870503|NCT02915302|143258299|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Victoria lineage)|1.4|||||TWO_SIDED|95.0|-2.78|5.56|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||5.56|-2.78|
71870504|NCT02915302|143258299|NON_INFERIORITY|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was \>-10%.|Difference in SCR (B Yamagata lineage)|3.4|||||TWO_SIDED|95.0|-0.465|7.36|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.||7.36|-0.465|
71870505|NCT00645801|143258305|SUPERIORITY|||||||0.05||||||A 2-sided 2 sample t test was used to compare the overall cleanliness score between the 2 treatment groups.|t-test, 2 sided|||Based on the assumption that 70% of patients using PEG plus placebo (group 2) will have good results, by allocating 100 cases in each group, we will have 84% power to detect a difference of 18% or more in the effectiveness of PEG plus lubiprostone combination (group 1) (eg, 70% in group 2 vs. 88% in group 1) at the alpha level of significancelevel of significance.||||0.05
71870506|NCT00645801|143258306|SUPERIORITY||||||<|0.05|||||||2 sided Cochran-Armitage trend test|||||||<0.05
71870507|NCT00645801|143258307|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71870508|NCT00705679|143258311|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.37|TWO_SIDED|95.0|0.61|1.21||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.21|0.61|0.37
71870509|NCT00705679|143258314|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.49||||0.07|TWO_SIDED|95.0|0.97|2.29||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||2.29|0.97|0.07
71870510|NCT00705679|143258317|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.04||||0.81|TWO_SIDED|95.0|0.73|1.49||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.||1.49|0.73|0.81
71870511|NCT00705679|143258318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED||||||Fisher Exact|Two-sided Fisher's Exact Test.||||||0.004
71870512|NCT00932113|143258319|OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71870513|NCT00522873|143258358|SUPERIORITY_OR_OTHER||proportion|0.0|||||TWO_SIDED|95.0|0.0|0.0119|||||The number of women who had a biopsy classified as 'hyperplasia or worse' was divided by the number of women with an evaluable biopsy (i.e. classified as 'normal' after 1 year of treatment or as 'hyperplasia or worse' at any time during the study).|Exact 95% confidence interval for proportion of participants with hyperplasia or worse at EoS||0.0119|0.0000|
71870514|NCT00522873|143258359|SUPERIORITY_OR_OTHER||proportion|0.687|||||TWO_SIDED|95.0|0.637|0.734||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.734|0.637|
71870515|NCT00522873|143258359|SUPERIORITY_OR_OTHER||proportion|0.593|||||TWO_SIDED|95.0|0.496|0.684||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.684|0.496|
71870516|NCT00522873|143258360|SUPERIORITY_OR_OTHER||proportion|0.789|||||TWO_SIDED|95.0|0.743|0.83||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.830|0.743|
71870517|NCT00522873|143258360|SUPERIORITY_OR_OTHER||proportion|0.84|||||TWO_SIDED|95.0|0.756|0.904||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea||0.904|0.756|
71870518|NCT01878214|143258440|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||||||0.76
71870519|NCT01878214|143258441|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||Regression, Logistic|||||||0.79
71870520|NCT01878214|143258442|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED||||||Regression, Logistic|||Smoking frequency||||0.63
71870521|NCT01878214|143258442|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Regression, Logistic|||Smoking quantity||||0.30
71870522|NCT01878214|143258443|SUPERIORITY_OR_OTHER|||||||0.28|TWO_SIDED||||||Regression, Logistic|||||||0.28
71870523|NCT01878214|143258444|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Regression, Logistic|||Motivation to quit||||0.09
71870524|NCT01878214|143258444|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||Thinking about quitting||||0.04
71870525|NCT00946101|143258445|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.|rate difference|0.0|||||TWO_SIDED|95.0|-6.4|3.1|||score|||The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference \< 10%||3.1|-6.4|
71870526|NCT00946101|143258446|SUPERIORITY_OR_OTHER||rate difference|1.5|||||TWO_SIDED|95.0|-12.8|9.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||9.8|-12.8|
71870527|NCT00946101|143258447|SUPERIORITY_OR_OTHER||rate difference|4.9|||||TWO_SIDED|95.0|-9.6|13.8|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||13.8|-9.6|
71913917|NCT03136484|143348500|NON_INFERIORITY|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.|Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
71870528|NCT00946101|143258448|SUPERIORITY_OR_OTHER||rate difference|17.5|||||TWO_SIDED|95.0|5.5|27.1|||score|||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||27.1|5.5|
71870529|NCT00946101|143258449|SUPERIORITY_OR_OTHER||rate difference|5.1|||||TWO_SIDED|95.0|-8.4|17.6|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||17.6|-8.4|
71870530|NCT00946101|143258452|SUPERIORITY_OR_OTHER||rate difference|13.3|||||TWO_SIDED|95.0|-0.4|25.7|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||25.7|-0.4|
71870531|NCT00946101|143258455|SUPERIORITY_OR_OTHER||rate difference|-6.3|||||TWO_SIDED|95.0|-19.7|6.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||6.1|-19.7|
71870532|NCT00946101|143258458|SUPERIORITY_OR_OTHER||rate difference|-6.4|||||TWO_SIDED|95.0|-20.3|7.1|||score|||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.||7.1|-20.3|
71870533|NCT00946101|143258467|SUPERIORITY_OR_OTHER||rate difference|7.0|||||TWO_SIDED|95.0|-6.1|14.7|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||14.7|-6.1|
71870534|NCT00946101|143258468|SUPERIORITY_OR_OTHER||rate difference|7.2|||||TWO_SIDED|95.0|-5.8|15.1|||score|||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||15.1|-5.8|
71870535|NCT00946101|143258469|SUPERIORITY_OR_OTHER||rate difference|16.7|||||TWO_SIDED|95.0|5.9|25.2|||score|||The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).||25.2|5.9|
71870536|NCT00069108|143258491|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|Hazard Ratio (HR)|1.03||||0.00584|TWO_SIDED|95.0|0.87|1.24|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.24|0.87|0.00584
71913918|NCT03136484|143348500|SUPERIORITY||Treatment difference|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.||-0.33|-0.65|<.0001
71913919|NCT00360685|143348561|SUPERIORITY_OR_OTHER|||||||0.06|||||||Fisher Exact|||Sample size was based on the difference in the proportion of patients in each arm who were predicted to develop severe mucositis defined as clinical grade 3 or 4 per the CTCAE. A sample-size of 42 evaluable subjects per study-arm allowed detection of an absolute difference of 30%, which corresponds to a reduction in the incidence of severe mucositis from 60% in the methotrexate arm to 30% in the MMF arm (alpha=0.05, power=0.80).||||0.06
71913920|NCT00360685|143348562|SUPERIORITY_OR_OTHER|||||||0.8|||||||K-sample tests for comparing the cumulat|||||||0.8
71913921|NCT00360685|143348563|SUPERIORITY_OR_OTHER|||||||0.58|||||||Log Rank|||||||0.58
71913922|NCT00856986|143348585|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.52||||||95.0|-0.68|-0.36|||ANCOVA|||The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.||-0.36|-0.68|
71913923|NCT00856986|143348586|SUPERIORITY_OR_OTHER||Estimated Treatment Difference, LSMean|-0.41||||||95.0|-0.6|-0.21|||ANCOVA||The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.|The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.||-0.21|-0.6|
71913924|NCT00856986|143348587|SUPERIORITY_OR_OTHER||Estimated treatment difference, LS mean|-0.51||||||95.0|-0.7|-0.31|||ANCOVA||The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects|||-0.31|-0.7|
71913925|NCT04018612|143348625|SUPERIORITY||LS Mean Difference|-21.84|STANDARD_ERROR_OF_MEAN|11.091||0.0258|ONE_SIDED|90.0||-7.53|||ANCOVA||SPID24 was analyzed using ANCOVA model with treatment group as a fixed effect and baseline (BL) Pain Intensity-Numerical Pain Relief Scale (PI-NPRS) as a covariate. The lower limit of one-sided 90% confidence interval (CI) was -∞|||-7.53||0.0258
71913926|NCT04018612|143348625|SUPERIORITY||LS Mean Difference|-25.74|STANDARD_ERROR_OF_MEAN|11.154||0.0115|ONE_SIDED|90.0||-11.35|||ANCOVA||SPID24 was analyzed using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The lower limit of one-sided 90% CI was -∞|||-11.35||0.0115
71913927|NCT04018612|143348626|SUPERIORITY||LS Mean Difference|12.72|STANDARD_ERROR_OF_MEAN|5.267||0.0087|ONE_SIDED|90.0|5.92||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.92|0.0087
71913928|NCT04018612|143348626|SUPERIORITY||LS Mean Difference|12.14|STANDARD_ERROR_OF_MEAN|5.297||0.012|ONE_SIDED|90.0|5.31||||ANCOVA||TOTPAR24 was analyzed using an ANCOVA model with treatment group as a fixed effect and baseline PI-NPRS as a covariate. The upper limit of one-sided 90% CI was +∞||||5.31|0.0120
71913929|NCT02999191|143348663|OTHER||Ratio|89.9|STANDARD_DEVIATION|36.0|||TWO_SIDED|90.0|73.304|110.25|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The Standard Deviation \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.25|73.304|
71913930|NCT02999191|143348663|OTHER||Ratio|170.78|STANDARD_DEVIATION|33.9|||TWO_SIDED|90.0|139.85|208.54|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||208.54|139.85|
71870537|NCT00069108|143258492|NON_INFERIORITY_OR_EQUIVALENCE|While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|0.93||||0.00223|TWO_SIDED|95.0|0.74|1.17|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|||1.17|0.74|0.00223
71870538|NCT00069108|143258493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||||1.37|0.91|
71913931|NCT02999191|143348664|OTHER||Ratio|84.17|STANDARD_DEVIATION|48.8|||TWO_SIDED|90.0|64.26|110.24|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fasted (numerator) and Solution, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||110.24|64.260|
71913932|NCT02999191|143348664|OTHER||Ratio|136.16|STANDARD_DEVIATION|54.8|||TWO_SIDED|90.0|99.885|185.61|||ANOVA||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 1467335: Tablets, fed (numerator) and Tablets, fasted (denominator). The parameter dispersion type \[SD\] is the intra-individual geometric coefficient of variation \[%\].|The statistical model used for the analysis of the endpoint was an ANOVA \[Analysis of Variance\] model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'sequence', 'subjects nested within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||185.61|99.885|
71913933|NCT01176240|143348693|SUPERIORITY_OR_OTHER|||||||0.978|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||Study 306A was initially designed as a blinded interim analysis by an independent DMC to ensure that the overall study was adequately powered. Study 306A was not powered to provide statistical significance as a stand alone study. Thus, no additional efficacy end points were prospectively defined beyond the primary end point.||||0.978
71913934|NCT01176240|143348694|SUPERIORITY_OR_OTHER|||||||0.018||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.018
71913935|NCT01176240|143348696|SUPERIORITY_OR_OTHER|||||||0.6||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the first secondary endpoint was not positive, statistical analysis was not performed on additional secondary endpoints.|Wilcoxon (Mann-Whitney)|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.||||||0.60
71913936|NCT01176240|143348702|SUPERIORITY_OR_OTHER|||||||0.238|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||||||0.238
71913937|NCT02043509|143348757|SUPERIORITY||Adjusted odds ratio|2.7|||||TWO_SIDED|95.0|0.93|9.35|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||9.35|0.93|
71913938|NCT02043509|143348758|SUPERIORITY||Adjusted odds ratio|1.03|||||TWO_SIDED|95.0|0.61|1.75|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||1.75|0.61|
71913939|NCT02043509|143348759|SUPERIORITY||Adjusted odds ratio|1.34|||||TWO_SIDED|95.0|0.79|2.31|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||2.31|0.79|
71913940|NCT02043509|143348760|SUPERIORITY||Adjusted odds ratio|1.67|||||TWO_SIDED|95.0|0.72|4.03|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||4.03|0.72|
71913941|NCT02043509|143348761|SUPERIORITY||Adjusted odds ratio|2.11|||||TWO_SIDED|95.0|0.89|5.46|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||5.46|0.89|
71870539|NCT00069108|143258494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||||1.47|0.95|
71870540|NCT00069108|143258495|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.4028|TWO_SIDED|95.0|0.79|1.77||p-value is for difference between response rates.|Chi-squared|||||1.77|0.79|0.4028
71913942|NCT02043509|143348762|SUPERIORITY||Adjusted odds ratio|3.16|||||TWO_SIDED|95.0|1.14|10.69|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||10.69|1.14|
71913943|NCT02043509|143348763|SUPERIORITY||Adjusted odds ratio|3.28|||||TWO_SIDED|95.0|0.9|17.36|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.|||17.36|0.90|
71913944|NCT02043509|143348764|SUPERIORITY|||||||0.118|||||||Mann-Whitney U-test|||||||0.118
71913945|NCT03189563|143348771|SUPERIORITY|||||||0.3656||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3656
71913946|NCT03189563|143348771|SUPERIORITY|||||||0.3119||||||p-value is from ANCOVA model adjusted for baseline motor MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3119
71913947|NCT03189563|143348772|SUPERIORITY|||||||0.147||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1470
71913948|NCT03189563|143348772|SUPERIORITY|||||||0.252||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2520
71870541|NCT00069108|143258496|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.2911|TWO_SIDED|95.0|0.81|2.01||p-value is for difference between response rates.|Chi-squared|||||2.01|0.81|0.2911
71870542|NCT00069108|143258497|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.87|1.23||||||||1.23|0.87|
71870543|NCT00069108|143258499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15|||||TWO_SIDED|95.0|0.79|1.68||||||||1.68|0.79|
71870544|NCT00069108|143258500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.81|1.12||||||||1.12|0.81|
71870545|NCT01415531|143258506|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.3|||<|0.0001|TWO_SIDED|95.0|-7.7|-4.8|||ANCOVA|||||-4.8|-7.7|<0.0001
71870546|NCT02344004|143258527|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving culture conversion by Month 6 was analyzed using the Cochran-Mantel-Haenszel test, stratified by smoking status and prior multi-drug regimen. The treatment comparison was tested at two-sided significance level of 0.05. The null hypothesis assumed that culture conversion by Month 6 is independent of treatment, and the alternative hypothesis assumed that culture conversion by Month 6 is associated with treatment.|The final analysis of the primary endpoint, the number of participants achieving culture conversion at by Month 6, was performed after the last participants completed Month 6 and his/her Month 6 sputum culture result was available.|||<0.0001
71870547|NCT02344004|143258528|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71870548|NCT02344004|143258529|SUPERIORITY|||||||0.7804|||||||Mixed Model Repeated Measures (MMRM)|||This was analyzed using a mixed model repeated measures (MMRM) analysis of change from Baseline at Months 4\&6. MMRM included treatment, month, treatment-by-month interaction, combination of smoking status \& prior MDR (4 levels: Yes/Yes, Yes/No, No/Yes, and No/No) as fixed factors, baseline 6MWD as a covariate \& baseline 6MWD-by-month interaction. An unstructured covariance matrix was used for the MMRM.|"* Baseline is defined as the last non-missing value prior to first dose of study drug.~* Statistics were obtained from an mixed-effects model repeated measures (MMRM) model with pattern-mixture modeling of missing values due to dropout, which included treatment, month, the treatment-by-month interaction, and the combination of smoking status and prior multidrug regimen as fixed factors, the baseline 6MWT distance as a covariate and baseline 6MWT distance-by-month interaction. MMRM included postbaseline data through Month 6.~* For baseline, n is the number of participants with a baseline score and at least 1 postbaseline score. For Month 6, n is the number of participants with a baseline score and a postbaseline score at the summarized visit."|||0.7804
71870549|NCT02344004|143258530|SUPERIORITY||Cox Proportional Hazard|3.92|||<|0.0001|TWO_SIDED|95.0|2.01|7.63|||Regression, Cox|||Kaplan Meier estimates for the distribution of time to culture conversion were constructed for treatment arms. The treatment comparison was made using the stratified log rank test for the ITT population. The estimated median time to culture conversion for each treatment arm was not estimable. The time to culture conversion was analyzed using Cox regression model to estimate hazards ratio.||7.63|2.01|<0.0001
71870550|NCT02996565|143258535|SUPERIORITY||Mean Difference (Net)|-0.76||||0.45|TWO_SIDED|95.0|-2.84|1.33||The threshold for statistical significance was p = 0.05.|planned contrast|The planned contrast compares model-predicted change in SBP from index to 365 days in Telehealth Care vs. Best Practice Clinic-Based Care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.33|-2.84|0.45
71870551|NCT02996565|143258536|SUPERIORITY|Random coefficients model predicted all EHR-documented DBPs from treatment group, days elapsed from index to each DBP (time) and treatment group by time with random clinic and patient intercepts.|Mean Difference (Net)|0.28||||0.64|TWO_SIDED|95.0|-0.95|1.51||The threshold for statistical significance was p\<0.05|planned contrast|The planned contrast compares the model-predicted change in DBP from index to 365 days in Telehealth care vs. index to 365 days in clinic based care.|adjusted for baseline SBP, baseline DBP, baseline age, sex, Asian race|||1.51|-0.95|0.64
71870552|NCT02996565|143258537|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.53|||<|0.001|TWO_SIDED|95.0|1.27|1.85||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.85|1.27|<0.001
71870553|NCT02996565|143258538|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.25||||0.03|TWO_SIDED|95.0|1.02|1.52||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood pf reporting high satisfaction at 6 months relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.52|1.02|0.03
71870554|NCT02996565|143258539|SUPERIORITY|Random coefficients model predicted the likelihood that smoking was current 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.01||||0.73|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of current smoking at 12 months in Telehealth care vs. clinic based care|unadjusted|||1.07|0.95|0.73
71913949|NCT03189563|143348773|SUPERIORITY|||||||0.1528||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1528
71870555|NCT02996565|143258540|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.17||||0.08|TWO_SIDED|95.0|0.98|1.4||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.4|.98|0.08
71913950|NCT03189563|143348773|SUPERIORITY|||||||0.6146||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 1 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6146
71870556|NCT02996565|143258541|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.11||||0.18|TWO_SIDED|95.0|0.95|1.29||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.29|0.95|0.18
71870557|NCT02996565|143258542|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.87|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.87|0.77
71870558|NCT02996565|143258543|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.8|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.80|0.32
71913951|NCT03189563|143348774|SUPERIORITY|||||||0.5691||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5691
71913952|NCT03189563|143348774|SUPERIORITY|||||||0.1309||||||p-value is from ANCOVA model adjusted for baseline S\&E scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1309
71913953|NCT03189563|143348775|SUPERIORITY|||||||0.7913||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.7913
71913954|NCT03189563|143348775|SUPERIORITY|||||||0.9399||||||p-value is from ANCOVA model adjusted for baseline PDQ-39 summary index. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.9399
71870559|NCT02996565|143258544|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.62|TWO_SIDED|95.0|0.76|1.19||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.19|0.76|0.62
71870560|NCT02996565|143258545|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.99||||0.87|TWO_SIDED|95.0|0.91|1.08||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the side effect was a problem at 6m relative to baseline in Telehealth vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.08|0.91|0.87
71870561|NCT02996565|143258546|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.95||||0.51|TWO_SIDED|95.0|0.82|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|0.82|0.51
71870562|NCT02996565|143258547|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.09||||0.41|TWO_SIDED|95.0|0.87|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.37|0.87|0.41
71870563|NCT02996565|143258548|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.18|TWO_SIDED|95.0|0.77|1.06||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity was helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.06|0.77|0.18
71913955|NCT03189563|143348776|SUPERIORITY|||||||0.4978||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.4978
71913956|NCT03189563|143348776|SUPERIORITY|||||||0.888||||||p-value is from ANCOVA model adjusted for baseline H\&Y scale total score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8880
71913957|NCT03189563|143348777|SUPERIORITY|||||||0.5755||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.5755
71913958|NCT03189563|143348777|SUPERIORITY|||||||0.1517||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 2 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.1517
71870564|NCT02996565|143258549|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.92||||0.31|TWO_SIDED|95.0|0.78|1.09||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.09|0.78|0.31
71870565|NCT02996565|143258550|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.56|TWO_SIDED|95.0|0.89|1.22||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the activity is helpful at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.22|0.89|0.56
71870566|NCT02996565|143258551|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.84||||0.08|TWO_SIDED|95.0|0.68|1.03||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.03|0.68|0.08
71913959|NCT03189563|143348778|SUPERIORITY|||||||0.2095||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2095
71913960|NCT03189563|143348778|SUPERIORITY|||||||0.6094||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 3 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.6094
71913961|NCT03189563|143348779|SUPERIORITY|||||||0.226||||||"p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score.~All statistical tests for efficacy are two-sided tests, with α=0.05."|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
71913962|NCT03189563|143348779|SUPERIORITY|||||||0.226||||||p-value is from ANCOVA model adjusted for baseline MDS-UPDRS part 4 subscale score All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.2260
71913963|NCT03189563|143348780|SUPERIORITY|||||||0.8274||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.8274
71913964|NCT03189563|143348780|SUPERIORITY|||||||0.3416||||||p-value is from ANCOVA model adjusted for baseline CGI-S score. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||Change from baseline is based on subjects with paired values.||||0.3416
71913965|NCT03189563|143348781|SUPERIORITY|||||||0.4052||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.4052
71913966|NCT03189563|143348781|SUPERIORITY|||||||0.2643||||||P-value is from ANCOVA model. All statistical tests for efficacy are two-sided tests, with α=0.05.|ANCOVA|||||||0.2643
71913967|NCT00927576|143348849|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of the results showed a 95% chance of finding a p\<0.05 difference in 166 subjects and a 99% chance of finding a p \<0.05 difference in 230 subjects in comparison of Group 1 controls and sTBI patients.|Difference in z-score, sTBI vs. controls|2.04|||<|0.001|TWO_SIDED||||||ANOVA|for repeated measures with effect sizes (omega squared).||The null hypotheses was that the severe TBI group would not differ from the control group in SRT latencies.||||< 0.001
71913968|NCT00927576|143348849|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p \< 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group..|z-score difference between groups|-0.3||||0.5|TWO_SIDED|||||The P-value reflects the likelihood of detection a difference of the magnitude observed.|ANOVA|||The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group.||||.50
71913969|NCT02019758|143348865|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.||||0.31
71913970|NCT02019758|143348866|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.||||0.70
71913971|NCT02019758|143348871|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.52|2.08||||||||2.08|0.52|
71913972|NCT02019758|143348872|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71913973|NCT02019758|143348873|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71913974|NCT02019758|143348874|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71913975|NCT04211961|143348902|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71913976|NCT04211961|143348903|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71913977|NCT04211961|143348904|SUPERIORITY|||||||0.3|||||||Fisher Exact|||||||0.3
71913978|NCT04211961|143348905|SUPERIORITY|||||||0.5|||||||Chi-squared|||||||0.5
71913979|NCT04211961|143348907|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71913980|NCT04211961|143348908|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71913981|NCT04211961|143348909|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71913982|NCT04211961|143348911|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||||||0.024
71913983|NCT04211961|143348912|SUPERIORITY|||||||0.9|||||||Fisher Exact|||||||0.9
71913984|NCT04211961|143348913|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71913985|NCT04211961|143348914|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71913986|NCT04211961|143348915|SUPERIORITY||||||>|0.9|||||||Fisher Exact|||||||>0.9
71913987|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.9825|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.9825
71913988|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.5737|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5737
71913989|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.5703|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5703
71913990|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.5684|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.||||0.5684
71913991|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.8235|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.8235
71913992|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.2384|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.2384
71913993|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.1634|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.1634
71913994|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.7816|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.||||0.7816
71913995|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.3917|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.3917
71913996|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.1749|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.1749
71913997|NCT01156363|143348926|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||<0.001
71913998|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0905|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.||||0.0905
71913999|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.3766|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.3766
71914000|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0253|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0253
71914001|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0209|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.0209
71914002|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.8206|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.||||0.8206
71914003|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0907|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0907
71914004|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0177|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0177
71914005|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.0050
71914006|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.3724|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.||||0.3724
71914007|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.2796|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.2796
71914008|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0066|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0066
71914009|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0081|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.0081
71914010|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.7853|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.||||0.7853
71914011|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0039|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.0039
71914012|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.3057|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3057
71914013|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.3374|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.3374
71914014|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.141|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.||||0.1410
71914015|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0017|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0017
71914016|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0677|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0677
71914017|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.1608|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.1608
71914018|NCT01156363|143348926|SUPERIORITY_OR_OTHER|||||||0.0196|TWO_SIDED||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.||||0.0196
71914019|NCT04882072|143348939|SUPERIORITY||Hazard Ratio (HR)|1.86|||||TWO_SIDED|95.0|0.41|8.47||||||||8.47|0.41|
71914020|NCT02918318|143348960|SUPERIORITY||Difference of Least Squares means|-1.0|STANDARD_ERROR_OF_MEAN|2.25||0.475|TWO_SIDED|90.0|-5.77|3.7||1-sided|Dunnett adjustment|||||3.70|-5.77|0.475
71914021|NCT02918318|143348960|SUPERIORITY||Difference of Least Squares means|0.6|STANDARD_ERROR_OF_MEAN|2.33||0.504|TWO_SIDED|90.0|-4.32|5.47||1-sided|Dunnett adjustment|||||5.47|-4.32|0.504
71914022|NCT02918318|143348960|SUPERIORITY||Difference of Least Squares means|-0.9|STANDARD_ERROR_OF_MEAN|2.26||0.482|TWO_SIDED|90.0|-5.66|3.83||1-sided|Dunnett adjustment|||||3.83|-5.66|0.482
71914023|NCT02023112|143348982|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|91.5|||||TWO_SIDED|95.0|80.1|96.6|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||96.6|80.1|
71870567|NCT02996565|143258552|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.9||||0.32|TWO_SIDED|95.0|0.73|1.11||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.11|.73|0.32
71870568|NCT02996565|143258553|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.14||||0.09|TWO_SIDED|95.0|0.98|1.33||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.33|0.98|0.09
71914024|NCT02023112|143348982|SUPERIORITY_OR_OTHER_LEGACY||percentage of participants with SVR12|75.0|||||TWO_SIDED|95.0|61.2|85.1|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."||85.1|61.2|
71914025|NCT03536923|143348988|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
71914026|NCT03536923|143348989|OTHER|||||||0.0009|||||||t-test, 1 sided|||||||0.0009
71914027|NCT03536923|143348991|OTHER|||||||0.0001|||||||t-test, 1 sided|||||||0.0001
71914028|NCT02228824|143348992|SUPERIORITY||Mean Difference (Final Values)|1.51|||<|0.001|TWO_SIDED|95.0|0.86|2.17|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||2.17|0.86|<0.001
71914029|NCT02228824|143348994|SUPERIORITY||Mean Difference (Final Values)|-38.5||||0.041|TWO_SIDED|95.0|-75.21|-1.78|||Mixed Models Analysis|||||-1.78|-75.21|0.041
71914030|NCT02228824|143348995|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.016|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE||||-0.13|-1.26|0.016
71914031|NCT02228824|143348996|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.03|TWO_SIDED|95.0|-0.04|-0.002|||Mixed Models Analysis|||||-0.002|-0.04|0.03
71914032|NCT02566109|143348998|OTHER|Estimation of Pearson correlation|Pearson Correlation Coefficient|-0.57472||||0.6102|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.6102
71914033|NCT02566109|143348998|OTHER|Correlation|Pearson Correlation Coefficient|0.25733||||0.8343|TWO_SIDED||||||Peason Correlation Coefficient|||Correlation between baseline and 6 months.||||0.8343
71914034|NCT02566109|143348999|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|-0.09487||||0.9395|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9395
71870569|NCT02996565|143258554|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.98||||0.77|TWO_SIDED|95.0|0.83|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.83|0.77
71870570|NCT02996565|143258555|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.21||||0.09|TWO_SIDED|95.0|0.97|1.5||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.5|.97|0.09
71870571|NCT02996565|143258556|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.64||||0.02|TWO_SIDED|95.0|0.45|0.92||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||0.92|0.45|0.02
71870572|NCT02996565|143258557|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.7||||0.006|TWO_SIDED|95.0|0.55|0.89||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||.89|.55|0.006
71870573|NCT02996565|143258558|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|0.78||||0.06|TWO_SIDED|95.0|0.6|1.01||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting the burden was a problem at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.01|0.60|0.06
71870574|NCT02996565|143258559|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.65|TWO_SIDED|95.0|0.94|1.1||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.10|0.94|0.65
71870575|NCT02996565|143258560|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.02||||0.83|TWO_SIDED|95.0|0.83|1.25||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.25|0.83|0.83
71870576|NCT02996565|143258561|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.41|TWO_SIDED|95.0|0.95|1.13||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.13|0.95|0.41
71914035|NCT02566109|143348999|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.97287||||0.1486|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.1486
71914036|NCT02566109|143349000|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.10327||||0.9341|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.||||0.9341
71914037|NCT02566109|143349000|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.99696||||0.0497|TWO_SIDED||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.||||0.0497
71914038|NCT02566109|143349001|OTHER|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.98432||||0.1129|TWO_SIDED||||||Pearson Correlation Coefficient|||||||0.1129
71914039|NCT01906476|143349006|NON_INFERIORITY|Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, \& Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, \& Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.|||||||||||||||||"Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:~Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)"|||
71914040|NCT01906476|143349007|SUPERIORITY||ICER estimate|-152.55|||||TWO_SIDED|95.0|-1143.09|1094.72||||||We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.||1094.72|-1143.09|
71914041|NCT02896192|143349013|OTHER||CI||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
71914042|NCT02896192|143349014|OTHER||||||<|0.0001||||||One-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest would achieve 10% weight loss.|Exact binomial test|||||||<0.0001
71870577|NCT02996565|143258562|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.04||||0.4|TWO_SIDED|95.0|0.94|1.16||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.16|0.94|0.40
71870578|NCT02996565|143258563|SUPERIORITY|Random coefficients model predicted baseline and 6 month patient-reported outcome from treatment group, time point and treatment group by time with random clinic intercept and patient scale parameter.|Risk Ratio (RR)|1.01||||0.74|TWO_SIDED|95.0|0.95|1.07||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The interaction RR compares the likelihood of reporting very/extremely confident at 6m relative to baseline in Telehealth care vs. clinic based care|adjusted for baseline DBP, baseline age, sex|||1.07|0.95|0.74
71870579|NCT02996565|143258564|SUPERIORITY|Random coefficients model predicted the likelihood that a new statin was current at 12 months by treatment group with random clinic intercept.|Risk Ratio (RR)|1.05||||0.71|TWO_SIDED|95.0|0.81|1.37||The threshold for statistical significance was p\<0.05|Mixed Models Analysis|The risk ratio compares the likelihood of a new statin medication that is current at 12 months in Telehealth care vs. clinic based care|adjusted for baseline SBP , baseline DBP, baseline age, sex, Asian race|||1.37|0.81|0.71
71870580|NCT02481947|143258565|NON_INFERIORITY|Non-inferiority margin = 12.6% (pre-specified)||||||0.016||||||The a priori threshold for statistical significance was 0.05.|Chi-squared|||||||0.016
71870581|NCT05249829|143258566|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
71870582|NCT05249829|143258567|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||2.010|1.546|
71870583|NCT05249829|143258568|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.535|||||TWO_SIDED|99.0|1.409|1.672||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||1.672|1.409|
71870584|NCT05249829|143258569|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667. Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.713|||||TWO_SIDED|96.0|1.583|1.853||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration.||1.853|1.583|
71870585|NCT05249829|143258570|NON_INFERIORITY|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.048|||||TWO_SIDED|99.0|0.958|1.147||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 29 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1818).||1.147|0.958|
71870586|NCT05249829|143258571|OTHER|Non-inferiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>0.667.|Geometric Mean Ratio|1.104|||||TWO_SIDED|96.0|1.032|1.18||||||Geometric Mean Ratio = GMCmRNA-1273.214/GMCmRNA-1273 against the ancestral strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=1418).||1.180|1.032|
71870587|NCT05249829|143258578|SUPERIORITY|Superiority was demonstrated if the lower bound of the 99% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.73|||||TWO_SIDED|99.0|1.493|2.005||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 29 after study vaccine administration.||2.005|1.493|
71870588|NCT05249829|143258578|SUPERIORITY|Superiority was demonstrated if the lower bound of the 96% CI of the Geometric Mean Ratio was \>1.|Geometric Mean Ratio|1.763|||||TWO_SIDED|96.0|1.546|2.01||||||Geometric Mean Ratio = GMCmRNA-1273.529/GMCmRNA-1273 against the B.1.1.529 strain at Day 85 after study vaccine administration. Reported statistical analysis based upon the number of participants with non-missing data at baseline and the corresponding timepoint (N=460).||2.010|1.546|
71870589|NCT02842827|143258613|OTHER|||||||0.3868|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.3868
71870590|NCT02842827|143258614|OTHER|||||||0.7744|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.7744
71870591|NCT02842827|143258615|OTHER|||||||0.508|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.5080
71870592|NCT02842827|143258616|OTHER|||||||0.6109|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.6109
71914043|NCT02896192|143349015|OTHER||Least Squares Mean|-25.73|||<|0.0001|TWO_SIDED|90.0|-28.49|-22.98|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.||-22.98|-28.49|<0.0001
71914044|NCT02896192|143349016|OTHER||Least Squares Mean|-27.77||||0.0005|TWO_SIDED|90.0|-40.58|-14.96|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.||-14.96|-40.58|0.0005
71914045|NCT02896192|143349017|OTHER|||||||0.0004||||||One-sided p-value obtained from exact binomial test, testing that ≥ 5% of participants in the population of interest would achieve ≥ 25% improvement in daily hunger score.|Exact binomial test|||||||0.0004
71870593|NCT02842827|143258617|OTHER|||||||0.1151|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.1151
71870594|NCT02842827|143258618|OTHER|||||||0.0791|||||||Kruskal-Wallis|p-value of the treatment effect was calculated between all dose arms with ≥3 participants||||||0.0791
71914046|NCT02896192|143349018|OTHER||Least Squares Mean|-18.1|||<|0.0001|TWO_SIDED|90.0|-21.27|-14.88|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.||-14.88|-21.27|<0.0001
71914047|NCT02896192|143349021|OTHER||Least Squares Mean|-27.4|||<|0.0001|TWO_SIDED|90.0|-30.6|-24.29|||Longitudinal mixed analysis of variance|||Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.||-24.29|-30.60|<0.0001
71914048|NCT02448914|143349043|NON_INFERIORITY_OR_EQUIVALENCE|Analysis was first to attempt to show non-inferiority. To show non-inferiority of TRIGEL over Duodopa, the lower limit of the two-sided CI for the treatment ratio had to be above the chosen non-inferiority margin of 0.9. If non-inferiority was shown, analysis continued with test of superiority. To show superiority of TRIGEL versus Duodopa, the lower confidence limit had to be above 1 (corresponding to a p-value less than 0.05).|back-transformed ratio|1.382|||<|0.0001|TWO_SIDED|95.0|1.264|1.511|||ANCOVA|||Levodopa AUC 0-14h/dose, was derived using the trapezoidal method and divided by the total administered dose of levodopa during the corresponding time interval.The primary endpoint was log transformed and analysed using an ANCOVA, adjusting for treatment, period and patient. The back-transformed ratio of TRIGEL over Duodopa was calculated together with 95% confidence intervals (CI) and the associated (2 sided) p value.||1.511|1.264|<0.0001
71914049|NCT00560794|143349061|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||The null hypothesis stated that the true MRD response probability (π) ≤ 5%.|1-sided exact binomial test|||||||0.0000
71914050|NCT04857892|143349075|OTHER||Ratio of geometric Least Square mean|1.025|||||TWO_SIDED|90.0|0.9335|1.126|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.126|0.9335|
71914051|NCT04857892|143349075|OTHER||Ratio of geometric Least Square mean|1.072|||||TWO_SIDED|90.0|0.9693|1.185|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.185|0.9693|
71914052|NCT04857892|143349076|OTHER||Ratio of geometric Least Square mean|1.126|||||TWO_SIDED|90.0|0.9918|1.278|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.278|0.9918|
71914053|NCT04857892|143349076|OTHER||Ratio of geometric Least Square mean|1.055|||||TWO_SIDED|90.0|0.9278|1.201|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.201|0.9278|
71914054|NCT04857892|143349077|OTHER||Ratio of geometric Least Square mean|1.036|||||TWO_SIDED|90.0|0.9209|1.166|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.166|0.9209|
71870595|NCT03386110|143258619|SUPERIORITY||Risk Ratio, log|1.19||||0.08|TWO_SIDED|95.0|-0.15|2.54|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-month follow-up, and controlled for the nesting of participants within couples.||2.54|-0.15|0.08
71870596|NCT03386110|143258619|SUPERIORITY||Risk Ratio, log|0.7||||0.25|TWO_SIDED|95.0|-0.49|1.89|||Mixed Models Analysis|Model testing whether condition predicted illicit drug use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||1.89|-0.49|0.25
71870597|NCT03386110|143258619|SUPERIORITY||Risk Ratio, log|1.79||||0.007|TWO_SIDED|95.0|0.49|3.09|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||3.09|0.49|0.007
71870598|NCT03386110|143258619|SUPERIORITY||Risk Ratio, log|-0.36||||0.71|TWO_SIDED|95.0|-2.26|1.53|||Mixed Models Analysis|Three-way interaction model testing whether baseline use (actor and partner) moderated the effect of condition on illicit drug use at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||1.53|-2.26|0.71
71870599|NCT03386110|143258620|SUPERIORITY||Risk Ratio, log|0.36||||0.36|TWO_SIDED|95.0|-0.65|1.37|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.37|-0.65|0.36
71870600|NCT03386110|143258620|SUPERIORITY||Risk Ratio, log|-0.18||||0.63|TWO_SIDED|95.0|-1.15|0.78|||Mixed Models Analysis|Model testing whether condition predicted CAS events at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.78|-1.15|0.63
71870601|NCT03386110|143258620|SUPERIORITY||Risk Ratio, log|-0.54||||0.42|TWO_SIDED|95.0|-1.85|0.77|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.77|-1.85|0.42
71870602|NCT03386110|143258620|SUPERIORITY||Risk Ratio, log|-1.7||||0.02|TWO_SIDED|95.0|-3.14|-0.27|||Mixed Models Analysis|Three-way interaction model testing whether baseline rates of CAS (actor and partner) moderated the effect of condition on CAS events at 6-months||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||-0.27|-3.14|0.02
71870603|NCT03386110|143258621|SUPERIORITY||Risk Ratio, log|0.48||||0.15|TWO_SIDED|95.0|-0.18|1.44|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 3-months||Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.||1.44|-0.18|0.15
71914055|NCT04857892|143349077|OTHER||Ratio of geometric Least Square mean|1.02|||||TWO_SIDED|90.0|0.9049|1.151|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax.|||1.151|0.9049|
71914056|NCT04857892|143349078|OTHER||Ratio of geometric Least Square mean|1.129|||||TWO_SIDED|90.0|1.067|1.195|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.195|1.067|
71914057|NCT04857892|143349078|OTHER||Ratio of geometric Least Square mean|1.112|||||TWO_SIDED|90.0|1.05|1.178|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf).|||1.178|1.050|
71914058|NCT04857892|143349079|OTHER||Ratio of geometric Least Square mean|1.164|||||TWO_SIDED|90.0|1.07|1.267|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.267|1.070|
71914059|NCT04857892|143349079|OTHER||Ratio of geometric Least Square mean|1.087|||||TWO_SIDED|90.0|0.9975|1.184|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t).|||1.184|0.9975|
71914060|NCT04857892|143349080|OTHER||Ratio of geometric Least Square mean|1.078|||||TWO_SIDED|90.0|1.036|1.122|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.122|1.036|
71914061|NCT04857892|143349080|OTHER||Ratio of geometric Least Square mean|1.032|||||TWO_SIDED|90.0|0.9914|1.075|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.075|0.9914|
71914062|NCT04857892|143349081|OTHER||Ratio of geometric Least Square mean|2.705|||||TWO_SIDED|90.0|2.135|3.427|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||3.427|2.135|
71914063|NCT04857892|143349082|OTHER||Ratio of geometric Least Square mean|2.761|||||TWO_SIDED|90.0|2.16|3.527|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||3.527|2.160|
71870604|NCT03386110|143258621|SUPERIORITY||Risk Ratio, log|0.24||||0.5|TWO_SIDED|95.0|-0.44|0.92|||Mixed Models Analysis|Model testing whether condition predicted marijuana use at 6-months||Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.||0.92|-0.44|0.50
71870605|NCT03386110|143258621|SUPERIORITY||Risk Ratio, log|-0.02||||0.91|TWO_SIDED|95.0|-0.34|0.31|||Mixed Models Analysis|Three-way interaction model testing whether baseline use moderated the effect of condition on marijuana use at 3-months||"Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.31|-0.34|0.910
71914064|NCT04857892|143349083|OTHER||Ratio of geometric Least Square mean|2.498|||||TWO_SIDED|90.0|1.821|3.425|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||3.425|1.821|
71914065|NCT04857892|143349084|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.451|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-inf)|||1.451|1.193|
71914066|NCT04857892|143349085|OTHER||Ratio of geometric Least Square mean|1.316|||||TWO_SIDED|90.0|1.193|1.452|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter AUC(0-t)|||1.452|1.193|
71914067|NCT04857892|143349086|OTHER||Ratio of geometric Least Square mean|1.232|||||TWO_SIDED|90.0|1.138|1.333|||||An analysis of variance with treatment, period, and sequence as fixed effects and participant nested within a sequence as a random effect was performed on the natural ln-transformed parameter Cmax|||1.333|1.138|
71914068|NCT00655811|143349189|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way anova was used to compare the mean COVAS values between groups.||||<0.05
71914069|NCT00655811|143349189|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.550
71914070|NCT00655811|143349189|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71914071|NCT00655811|143349189|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
71914072|NCT00655811|143349190|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71914073|NCT00655811|143349190|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71914074|NCT00655811|143349190|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71914075|NCT00655811|143349191|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71870606|NCT03386110|143258621|SUPERIORITY||Risk Ratio, log|0.34||||0.11|TWO_SIDED|95.0|-0.07|0.75|||Mixed Models Analysis|||"Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples."||0.75|-0.07|0.11
71914076|NCT00118404|143349231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.079|STANDARD_ERROR_OF_MEAN|0.39||0.42|TWO_SIDED|95.0|0.5|2.34|||Log Rank|log-rank chi-square = 0.038, df = 1, p \<=.42|Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.|The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.||2.34|0.50|.42
71914077|NCT00118404|143349231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.481|STANDARD_ERROR_OF_MEAN|0.38||0.02|TWO_SIDED|95.0|0.23|1.01|||Log Rank|log-rank chi-square = 3.92, df = 1|Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.|||1.01|.23|.02
71914078|NCT00118404|143349231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.519|STANDARD_ERROR_OF_MEAN|0.36||0.03|TWO_SIDED|95.0|0.26|1.06|||Log Rank|log-rank chi-square = 3.391, df = 1|Hazard ratio for relapse in C-CT group compared to that in the placebo group.|||1.06|0.26|.03
71914079|NCT00118404|143349231|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.501|STANDARD_ERROR_OF_MEAN|0.31||0.01|TWO_SIDED|95.0|0.27|0.93|||Log Rank|log-rank chi-square = 5.06, df = 1|Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.|||0.93|0.27|.01
71914080|NCT00118404|143349232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.988|STANDARD_ERROR_OF_MEAN|0.3||0.48|TWO_SIDED|95.0|0.55|1.76|||Log Rank|log-rank chi-square = 0.002, df = 1|Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.|||1.76|0.55|.48
71914081|NCT00118404|143349232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.31||0.14|TWO_SIDED|95.0|0.39|1.31|||Log Rank|Chi-square = 1.19, df = 1|Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.31|.39|.14
71870607|NCT01815138|143258623|OTHER||Odds Ratio (OR)|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71870608|NCT01815138|143258624|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71870609|NCT03426267|143258626|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71870610|NCT03426267|143258627|OTHER||||||<|0.0001|||||||Chi-squared|||||||<.0001
71870611|NCT00882687|143258633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3235|||||||Wilcoxon rank-sum test|||||||0.3235
71870612|NCT00882687|143258633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9144|||||||Wilcoxon rank-sum test|||||||0.9144
71870613|NCT00882687|143258633|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3324|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.3324
71870614|NCT00882687|143258634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5846|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.5846
71870615|NCT00882687|143258634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1493|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1493
71870616|NCT00882687|143258634|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0404|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0404
71870617|NCT00882687|143258635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0578|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.0578
71870618|NCT00882687|143258635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8988|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.8988
71870619|NCT00882687|143258635|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4709
71870620|NCT00882687|143258636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1773|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.1773
71870621|NCT00882687|143258636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4222|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4222
71870622|NCT00882687|143258636|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4326|TWO_SIDED||||||Wilcoxon rank-sum test|||||||0.4326
71870623|NCT02649946|143258640|SUPERIORITY|TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.|||||<|0.001||||||Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.|Chi-squared|||"Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.~Sample size calculation: 238 randomized subjects \[214 evaluable\] will give 92% power with one-sided type 1 error = 0.025."||||<0.001
71870624|NCT02649946|143258641|NON_INFERIORITY|Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.||||||0.0022|||||||Farrington and Manning|Non-inferiority test with non-inferiority margin of 10%.||"Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.~Sample size: 238 randomized subjects \[226 evaluable\] will give 85% power with one-sided type 1 error = 0.025."||||0.0022
71870625|NCT01809002|143258688|NON_INFERIORITY|The primary endpoint tested non-inferiority as compared to collagen nerve cuff and superior to no treatment. Non-inferiority is defined as the lower limit of the 95% CI about the difference of \> -2 and the upper limit of the 95% CI for s2PD for Avance of \< 13 in ITT table.|Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.087|1.574|||ANCOVA|||The analysis was performed using a pre-defined standard statistical analysis with a non-response/failure assigned a worst-case scenario value of 16mm.||1.574|-1.087|
71870626|NCT01809002|143258689|SUPERIORITY|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||||||0.035
71870627|NCT01809002|143258689|SUPERIORITY|||||||0.365|||||||Wilcoxon (Mann-Whitney)|||||||0.365
71870628|NCT01809002|143258690|SUPERIORITY|||||||0.915||||||The number and percentage of all treated subjects who recovered s2PD in the target repair at Month 12 (i.e., s2PD of 2 - 15 mm) were summarized by repair type. Differences between the repair types were assessed using a logistic regression analysis.|Regression, Logistic|||Responders were defined as subjects achieving s2PD of 2-15 mm on the target nerve repair.||||0.915
71870629|NCT01809002|143258691|SUPERIORITY||LS Means difference|-2.84|||||TWO_SIDED|95.0|-11.6316|5.9541||Pre-injury baseline was defined as s2PD in the contralateral digit associated with the target digit.|ANCOVA|This analysis was assessed in the ITT population, at Month 12 using the LS Mean differences from a repeated measures ANCOVA model.||||5.9541|-11.6316|
71870630|NCT01809002|143258692|SUPERIORITY|||||||0.792|||||||Kaplan-Meier median and 95% CI|Differences between the repair types were assessed with a KM log-rank test that was appropriate for the handing of interval-censored data.||||||0.792
71870631|NCT01809002|143258693|SUPERIORITY|||||||0.526|||||||Wilcoxon (Mann-Whitney)|This analysis was completed to detect a distribution shift of the MRCC score between repairs with PNA and repairs with nerve cuff at Month 12.||||||0.526
71870632|NCT01809002|143258694|OTHER||Mean Difference (Final Values)|-24.09|||||TWO_SIDED|||||||||"This analysis compares the change in 12 Month Pain VAS scores from Baseline. Missing or incomplete data was extrapolated using a pre-defined repeated measures modeling approach for calculations in this analysis.~This analysis assesses each treatment group for clinically meaningful improvement in VAS from Baseline assuming a Meaningful Clinically Important Difference delta of 20 points (mm)."||||
71870633|NCT01809002|143258696|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71870634|NCT01809002|143258697|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|This analysis was completed utilizing a one-sided Wilcoxon Rank Sum test.||||||0.037
71870635|NCT01809002|143258698|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|One-sided Wilcoxon Rank Sum test was utilized for this analysis.||||||0.021
71870636|NCT02318797|143258727|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Treatment by time interaction test||||<0.0001
71870637|NCT02318797|143258727|SUPERIORITY|||||||0.0019|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.0019
71870638|NCT02318797|143258728|SUPERIORITY|||||||0.4103|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4103
71870639|NCT02318797|143258728|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
71870640|NCT02318797|143258728|SUPERIORITY|||||||0.4068|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4068
71870641|NCT02318797|143258728|SUPERIORITY|||||||0.2656|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.2656
71870642|NCT02318797|143258729|SUPERIORITY|||||||0.4582|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.4582
71870643|NCT02318797|143258729|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
71870644|NCT02318797|143258729|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.05
71870645|NCT02318797|143258729|SUPERIORITY|||||||0.1792|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.1792
71870646|NCT02318797|143258730|SUPERIORITY|||||||0.2179|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.2179
71870647|NCT02318797|143258730|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)||||<0.0001
71914082|NCT00118404|143349232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.715|STANDARD_ERROR_OF_MEAN|0.3||0.13|TWO_SIDED|95.0|0.4|1.29|||Log Rank|chi-square = 1.262, df = 1|Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.|||1.29|.40|.13
71914083|NCT00118404|143349232|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.717|STANDARD_ERROR_OF_MEAN|0.26||0.1|TWO_SIDED|95.0|0.43|1.2|||Log Rank|Chi-square = 1.595, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.|||1.20|.43|.10
71914084|NCT00118404|143349233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.075|STANDARD_ERROR_OF_MEAN|0.27||0.4|TWO_SIDED|95.0|0.63|1.84|||Log Rank|chi-square = .07, df = 1|Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.|||1.84|.63|.40
71914085|NCT00118404|143349233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.649|STANDARD_ERROR_OF_MEAN|0.28||0.61|TWO_SIDED|95.0|0.37|1.13|||Log Rank|chi-square = 2.407, df = 1|Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.|||1.13|.37|.61
71914086|NCT00118404|143349233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.701|STANDARD_ERROR_OF_MEAN|0.27||0.09|TWO_SIDED|95.0|0.41|1.19|||Log Rank|chi-square = 1.731, df = 1|Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.|||1.19|.41|.09
71914087|NCT00118404|143349233|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.676|STANDARD_ERROR_OF_MEAN|0.24||0.05|TWO_SIDED|95.0|0.42|1.08|||Log Rank|chi-square = 2.705, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.|||1.08|.42|.05
71870648|NCT02318797|143258730|SUPERIORITY|||||||0.4797|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction||||0.4797
71870649|NCT02318797|143258730|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)||||0.0014
71870650|NCT02318797|143258731|SUPERIORITY|||||||0.0058|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0058
71870651|NCT02318797|143258732|SUPERIORITY|||||||0.0014|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.0014
71870652|NCT02318797|143258733|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0001
71870653|NCT02318797|143258734|SUPERIORITY|||||||0.5566|||||||Mixed Models Analysis|||Treatment by time interaction test||||0.5566
71870654|NCT02318797|143258734|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
71870655|NCT02318797|143258735|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.002
71870656|NCT02318797|143258736|SUPERIORITY|||||||0.0029|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0029
71870657|NCT02318797|143258737|SUPERIORITY|||||||0.0021|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0021
71870658|NCT02318797|143258738|SUPERIORITY|||||||0.1183|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1183
71870659|NCT02318797|143258738|SUPERIORITY|||||||0.0569|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.0569
71870660|NCT02318797|143258739|SUPERIORITY|||||||0.0745|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0745
71870661|NCT02318797|143258739|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||<0.0001
71870662|NCT02318797|143258740|SUPERIORITY|||||||0.1653|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.1653
71870663|NCT02318797|143258740|SUPERIORITY|||||||0.1772|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.1772
71870664|NCT02318797|143258741|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction||||<0.0001
71870665|NCT02318797|143258742|SUPERIORITY|||||||0.0202|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.0202
71870666|NCT02318797|143258743|SUPERIORITY|||||||0.4715|||||||Mixed Models Analysis|||Test for treatment by time interaction||||0.4715
71870667|NCT02318797|143258743|SUPERIORITY|||||||0.9209|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)||||0.9209
71914088|NCT00807014|143349234|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.|ANCOVA|||||||<0.001
71914089|NCT01628042|143349253|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.83|||||TWO_SIDED|90.0|1.36|2.46|||ANCOVA|||||2.46|1.36|
71914090|NCT01628042|143349253|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|2.06|||||TWO_SIDED|90.0|1.55|2.74|||ANCOVA|||||2.74|1.55|
71914091|NCT01628042|143349253|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.49|||||TWO_SIDED|90.0|1.11|2.0|||ANCOVA|||||2.00|1.11|
71914092|NCT01628042|143349254|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.42|||||TWO_SIDED|90.0|0.89|2.27|||ANCOVA|||||2.27|0.89|
71914093|NCT01628042|143349254|SUPERIORITY_OR_OTHER||Geometric least-squares mean ration|1.68|||||TWO_SIDED|90.0|1.07|2.63|||ANCOVA|||||2.63|1.07|
71914094|NCT01628042|143349254|SUPERIORITY_OR_OTHER||Geometric least-squares mean ratio|1.96|||||TWO_SIDED|90.0|1.23|3.13|||ANCOVA|||||3.13|1.23|
71914095|NCT01628042|143349255|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|90.0|0.41|0.74|||ANCOVA|||||0.74|0.41|
71914096|NCT01628042|143349255|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.49|||||TWO_SIDED|90.0|0.36|0.65|||ANCOVA|||||0.65|0.36|
71914097|NCT01628042|143349255|SUPERIORITY_OR_OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|90.0|0.5|0.9|||ANCOVA|||||0.90|0.50|
71914098|NCT01696396|143349274|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.|Odds Ratio (OR)|1.15||||0.76|TWO_SIDED|90.0|0.54|2.44|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.44|0.54|0.76
71914099|NCT01696396|143349274|SUPERIORITY||Difference in Adjusted Remission Rates|1.6|||||TWO_SIDED|90.0|-7.9|8.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.9|-7.9|
71914100|NCT01696396|143349274|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.91||||0.22|TWO_SIDED|90.0|0.8|4.57|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.57|0.80|0.22
71914101|NCT01696396|143349274|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|9.1|||||TWO_SIDED|90.0|-4.6|19.4||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||19.4|-4.6|
71914102|NCT01696396|143349274|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.05||||0.25|TWO_SIDED|90.0|0.74|5.73|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.73|0.74|0.25
71914103|NCT01696396|143349274|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|10.3|||||TWO_SIDED|90.0|-6.8|22.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-6.8|
71914104|NCT01696396|143349275|SUPERIORITY||Odds Ratio (OR)|1.78||||0.16|TWO_SIDED|90.0|0.9|3.53|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.53|0.90|0.16
71914105|NCT01696396|143349275|SUPERIORITY||Difference in Adjusted Remission Rates|10.9|||||TWO_SIDED|90.0|-1.8|21.0||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||21.0|-1.8|
71914106|NCT01696396|143349275|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.12||||0.13|TWO_SIDED|90.0|0.93|4.84|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.84|0.93|0.13
71914107|NCT01696396|143349275|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|14.7|||||TWO_SIDED|90.0|-2.1|27.5||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.5|-2.1|
71914108|NCT01696396|143349275|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.1||||0.056|TWO_SIDED|90.0|1.17|8.2|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.20|1.17|0.056
71914109|NCT01696396|143349275|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|23.7|||||TWO_SIDED|90.0|2.8|39.2||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||39.2|2.8|
71914110|NCT01696396|143349276|SUPERIORITY||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|90.0|1.27|4.01|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.01|1.27|0.021
71914111|NCT01696396|143349276|SUPERIORITY||Difference in Adjusted Response Rates|19.8|||||TWO_SIDED|90.0|5.8|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|5.8|
71914112|NCT01696396|143349276|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.9||||0.14|TWO_SIDED|90.0|0.94|3.87|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.87|0.94|0.14
71914113|NCT01696396|143349276|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.7|||||TWO_SIDED|90.0|-2.3|29.7||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||29.7|-2.3|
71914114|NCT01696396|143349276|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.87||||0.23|TWO_SIDED|90.0|0.79|4.39|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.39|0.79|0.23
71914115|NCT01696396|143349276|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.1|||||TWO_SIDED|90.0|-6.4|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.3|-6.4|
71914116|NCT01696396|143349277|SUPERIORITY||Odds Ratio (OR)|1.98||||0.047|TWO_SIDED|90.0|1.13|3.47|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.47|1.13|0.047
71914117|NCT01696396|143349277|SUPERIORITY||Difference in Adjusted Response Rates|16.0|||||TWO_SIDED|90.0|2.4|27.1||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||27.1|2.4|
71914118|NCT01696396|143349277|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|90.0|0.52|2.29|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.29|0.52|0.84
71914119|NCT01696396|143349277|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|1.9|||||TWO_SIDED|90.0|-15.2|15.2||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||15.2|-15.2|
71914120|NCT01696396|143349277|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|1.15||||0.78|TWO_SIDED|90.0|0.49|2.72|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.72|0.49|0.78
71914121|NCT01696396|143349277|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|3.1|||||TWO_SIDED|90.0|-17.4|18.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||18.3|-17.4|
71914122|NCT01696396|143349278|SUPERIORITY||Odds Ratio (OR)|1.65||||0.34|TWO_SIDED|90.0|0.69|3.91|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.91|0.69|0.34
71914123|NCT01696396|143349278|SUPERIORITY||Difference in Adjusted Remission Rates|5.0|||||TWO_SIDED|90.0|-3.9|11.7||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.7|-3.9|
71870668|NCT02390050|143258784|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.34|-0.76|< 0.0001
71870669|NCT02390050|143258784|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.47|-0.89|< 0.0001
71870670|NCT02390050|143258784|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||||-0.59|-1.01|< 0.0001
71870671|NCT02390050|143258785|SUPERIORITY||Odds Ratio (OR)|2.1||||0.1308|TWO_SIDED|95.0|0.8|5.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 5 mg bexagliflozin group was compared to placebo group.||5.3|0.8|0.1308
71870672|NCT02390050|143258785|SUPERIORITY||Odds Ratio (OR)|2.0||||0.1294|TWO_SIDED|95.0|0.8|5.1|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 10 mg bexagliflozin group was compared to placebo group.||5.1|0.8|0.1294
71870673|NCT02390050|143258785|SUPERIORITY||Odds Ratio (OR)|4.2||||0.0015|TWO_SIDED|95.0|1.7|10.3|||Regression, Logistic|Treatment, country, baseline HbA1c and prior anti-diabetic treatment status as predictor variables and a dependable variable of 1 (\<7%) or 0 (\>7%).||Odds ratio of having at least 1 post-baseline HbA1c value \<7% in the 20 mg bexagliflozin group was compared to placebo group.||10.3|1.7|0.0015
71870674|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-0.74|||||TWO_SIDED|95.0|-1.13|-0.36||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.36|-1.13|
71870675|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-0.76|||||TWO_SIDED|95.0|-1.15|-0.38||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.38|-1.15|
71870676|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-0.99|||||TWO_SIDED|95.0|-1.38|-0.61||||||Week 2: Difference in LS mean change in body weight from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.61|-1.38|
71870677|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-1.53|-0.52||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.52|-1.53|
71870678|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-1.45|||||TWO_SIDED|95.0|-1.95|-0.94||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.94|-1.95|
71870679|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-1.51|||||TWO_SIDED|95.0|-2.01|-1.01||||||Week 6: Difference in LS mean change in body weight from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.01|-2.01|
71870680|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-1.44|||<|0.0001|TWO_SIDED|95.0|-2.12|-0.76||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.76|-2.12|< 0.0001
71870681|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.26|-0.91||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.91|-2.26|< 0.0001
71914124|NCT01696396|143349278|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.82||||0.078|TWO_SIDED|90.0|1.07|7.41|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.41|1.07|0.078
71914125|NCT01696396|143349278|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|12.8|||||TWO_SIDED|90.0|-0.6|22.6||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.6|-0.6|
71870682|NCT02390050|143258786|SUPERIORITY||Difference of LS Means|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.43|-1.08||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline weight as covariates||Week 12: Difference in LS mean change in body weight from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-1.08|-2.43|< 0.0001
71870683|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-0.48|||||TWO_SIDED|95.0|-0.9|-0.06||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.06|-0.90|
71870684|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-0.9|||||TWO_SIDED|95.0|-1.31|-0.48||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.48|-1.31|
71870685|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-1.04|||||TWO_SIDED|95.0|-1.45|-0.62||||||Week 2: Difference in LS mean change in FPG from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.62|-1.45|
71870686|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-0.93|||||TWO_SIDED|95.0|-1.39|-0.48||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.48|-1.39|
71683174|NCT05727306|142884373|OTHER||Hazard Ratio (HR)|8.26|||||TWO_SIDED|95.0|7.55|9.04|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||9.04|7.55|
71914126|NCT01696396|143349278|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|3.37||||0.083|TWO_SIDED|90.0|1.07|10.66|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.66|1.07|0.083
71914127|NCT01696396|143349278|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|16.0|||||TWO_SIDED|90.0|-1.2|28.3||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||28.3|-1.2|
71914128|NCT01696396|143349279|SUPERIORITY||Odds Ratio (OR)|1.52||||0.47|TWO_SIDED|90.0|0.59|3.93|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.93|0.59|0.47
71914129|NCT01696396|143349279|SUPERIORITY||Difference in Adjusted Remission Rates|2.8|||||TWO_SIDED|90.0|-4.7|8.1||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.1|-4.7|
71914130|NCT01696396|143349279|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.32||||0.21|TWO_SIDED|90.0|0.77|6.98|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.98|0.77|0.21
71914131|NCT01696396|143349279|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|6.8|||||TWO_SIDED|90.0|-4.3|14.5||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.5|-4.3|
71914132|NCT01696396|143349279|SUPERIORITY|Analysis was not part of the formal testing|Odds Ratio (OR)|2.66||||0.21|TWO_SIDED|90.0|0.75|9.45|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.45|0.75|0.21
71914133|NCT01696396|143349279|SUPERIORITY|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|8.4|||||TWO_SIDED|90.0|-6.0|17.9||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||17.9|-6.0|
71914134|NCT01696396|143349280|SUPERIORITY||LS Mean Treatment Difference|-42.09||||0.006|TWO_SIDED|90.0|-67.3|-16.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-16.9|-67.3|0.006
71914135|NCT01696396|143349280|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-40.79||||0.095|TWO_SIDED|90.0|-81.5|-0.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-0.5|-81.5|0.095
71914136|NCT01696396|143349280|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-36.84||||0.11|TWO_SIDED|90.0|-74.3|0.7|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||0.7|-74.3|0.11
71683175|NCT05727306|142884374|OTHER||Hazard Ratio (HR)|1.36|||||TWO_SIDED|95.0|1.17|1.57|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.57|1.17|
71870687|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-1.17|||||TWO_SIDED|95.0|-1.62|-0.72||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.72|-1.62|
71870688|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-1.1|||||TWO_SIDED|95.0|-1.55|-0.65||||||Week 6: Difference in LS mean change in FPG from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.65|-1.55|
71870689|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-0.85||||0.0002|TWO_SIDED|95.0|-1.29|-0.41||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.41|-1.29|0.0002
71870690|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.49|-0.6||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.60|-1.49|< 0.0001
71870691|NCT02390050|143258787|SUPERIORITY||Difference of LS Means|-1.07|||<|0.0001|TWO_SIDED|95.0|-1.52|-0.63||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline FPG as covariates||Week 12: Difference in LS mean change in FPG from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.63|-1.52|< 0.0001
71870692|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-0.19|||||TWO_SIDED|95.0|-3.9|3.51||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||3.51|-3.90|
71870693|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-2.41|||||TWO_SIDED|95.0|-6.09|1.28||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.28|-6.09|
71870694|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-4.25|||||TWO_SIDED|95.0|-7.93|-0.58||||||Week 2: Difference in LS mean change in SBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.58|-7.93|
71870695|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-0.18|||||TWO_SIDED|95.0|-2.5|2.13||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.13|-2.50|
71870696|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-1.74|||||TWO_SIDED|95.0|-4.03|0.56||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.56|-4.03|
71870697|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-2.15|||||TWO_SIDED|95.0|-4.45|0.14||||||Week 2: Difference in LS mean change in DBP from baseline to week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.14|-4.45|
71870698|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-4.57|2.9||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.90|-4.57|
71870699|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-3.39|||||TWO_SIDED|95.0|-7.12|0.34||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||0.34|-7.12|
71870700|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-2.51|||||TWO_SIDED|95.0|-6.21|1.2||||||Week 6: Difference in LS mean change in SBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.20|-6.21|
71870701|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|0.25|||||TWO_SIDED|95.0|-2.15|2.66||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||2.66|-2.15|
71870702|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-1.02|||||TWO_SIDED|95.0|-3.42|1.38||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.38|-3.42|
71914137|NCT01696396|143349281|SUPERIORITY||LS Mean Treatment Difference|-27.47||||0.045|TWO_SIDED|90.0|-50.0|-4.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||-4.9|-50.0|0.045
71914138|NCT01696396|143349281|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-23.59||||0.27|TWO_SIDED|90.0|-58.7|11.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||11.5|-58.7|0.27
71870703|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-0.84|||||TWO_SIDED|95.0|-3.22|1.54||||||Week 6: Difference in LS mean change in DBP from baseline to week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||1.54|-3.22|
71870704|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-2.16||||0.3001|TWO_SIDED|95.0|-6.26|1.94||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||1.94|-6.26|0.3001
71870705|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-4.41||||0.0343|TWO_SIDED|95.0|-8.49|-0.33||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.33|-8.49|0.0343
71870706|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-3.83||||0.0679|TWO_SIDED|95.0|-7.95|0.28|||ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in SBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.28|-7.95|0.0679
71870707|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-2.24||||0.0776|TWO_SIDED|95.0|-4.73|0.25||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.25|-4.73|0.0776
71870708|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-1.47||||0.2415|TWO_SIDED|95.0|-3.95|1.0||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||1.00|-3.95|0.2415
71870709|NCT02390050|143258788|SUPERIORITY||Difference of LS Means|-2.04||||0.1086|TWO_SIDED|95.0|-4.54|0.46||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline SBP as covariates||Week 12: Difference in LS mean change in DBP from baseline to week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||0.46|-4.54|0.1086
71914139|NCT01696396|143349281|SUPERIORITY|Analysis was not part of the formal testing|LS Mean Treatment Difference|-16.37||||0.45|TWO_SIDED|90.0|-51.8|19.1|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||19.1|-51.8|0.45
71914140|NCT00394277|143349285|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.075||||0.584||95.0|0.831|1.391||All secondary comparisons were tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.||1.391|0.831|0.584
71914141|NCT00394277|143349286|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.039||||0.775||95.0|0.803|1.344||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.344|0.803|0.775
71914142|NCT00394277|143349287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.004||||0.973||95.0|0.777|1.299||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.299|0.777|0.973
71914143|NCT00394277|143349288|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.008||||0.951||95.0|0.78|1.304||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)||1.304|0.780|0.951
71870710|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.09|||||TWO_SIDED|95.0|-0.2|0.03||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||0.03|-0.20|
71870711|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.02|-0.24|
71870712|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.13|||||TWO_SIDED|95.0|-0.24|-0.02||||||Week 2: Difference in LS Mean change in HbA1c (%) from baseline to Week 2 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.02|-0.24|
71914144|NCT02712008|143349290|SUPERIORITY|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|-2.09||||0.1368|TWO_SIDED|95.0||0.67||Threshold for significance at 0.05 level.|ANCOVA|||||0.67|- 4.84|0.1368
71870713|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.45|||||TWO_SIDED|95.0|-0.62|-0.28||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.28|-0.62|
71914145|NCT02712008|143349290|SUPERIORITY||Least square mean difference|0.04||||0.9716|TWO_SIDED|95.0||2.18||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||2.18|- 2.10|0.9716
71914146|NCT02712008|143349291|SUPERIORITY||Least square mean difference|2.15||||0.1665|TWO_SIDED|95.0|-0.9|5.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.20|-0.90|0.1665
71914147|NCT02712008|143349291|SUPERIORITY||Least square mean difference|1.9||||0.2223|TWO_SIDED|95.0|-1.16|4.95||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||4.95|-1.16|0.2223
71914148|NCT02712008|143349291|SUPERIORITY||Least square mean difference|0.39||||0.7943|TWO_SIDED|95.0|-2.54|3.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.32|-2.54|0.7943
71914149|NCT02712008|143349291|SUPERIORITY||Least square mean difference|0.66||||0.6655|TWO_SIDED|95.0|-2.35|3.67||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||3.67|-2.35|0.6655
71870714|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.49|||||TWO_SIDED|95.0|-0.66|-0.32||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.32|-0.66|
71914150|NCT02712008|143349291|SUPERIORITY||Least square mean difference|2.33||||0.1278|TWO_SIDED|95.0|-0.67|5.33||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||5.33|-0.67|0.1278
71914151|NCT02712008|143349291|SUPERIORITY||Least square mean difference|-1.51||||0.3159|TWO_SIDED|-1.51|-4.47|1.45||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||1.45|-4.47|0.3159
71914152|NCT02712008|143349291|SUPERIORITY||Least square mean difference|-0.27||||0.8537|TWO_SIDED|95.0|-3.18|2.63||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||2.63|-3.18|0.8537
71914153|NCT02712008|143349292|SUPERIORITY||Least square mean difference|-24.43||||0.1105|TWO_SIDED|95.0|-54.46|5.61||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||5.61|-54.46|0.1105
71914154|NCT02712008|143349292|SUPERIORITY||Least square mean difference|-27.79||||0.0183|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.||- 4.74|- 50.83|0.0183
71914155|NCT02712008|143349293|SUPERIORITY||Least square mean difference|-55.91||||0.004|TWO_SIDED|95.0||||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||- 18.01|- 93.81|0.0040
71914156|NCT02712008|143349293|SUPERIORITY||Least square mean difference|-40.51||||0.0365|TWO_SIDED|95.0|-78.46|-2.57||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.57|-78.46|0.0365
71914157|NCT02712008|143349293|SUPERIORITY||Least square mean difference|-37.15||||0.0454|TWO_SIDED|95.0|-73.53|-0.77||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-0.77|-73.53|0.0454
71914158|NCT02712008|143349293|SUPERIORITY||Least square mean difference|1.75||||0.9266|TWO_SIDED|95.0|-35.54|39.03||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||39.03|-35.54|0.9266
71914159|NCT02712008|143349293|SUPERIORITY||Least square mean difference|-15.49||||0.4116|TWO_SIDED|95.0|-52.58|21.59||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||21.59|-52.58|0.4116
71914160|NCT02712008|143349293|SUPERIORITY||Least square mean difference|3.36||||0.8574|TWO_SIDED|95.0|-33.42|40.14||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||40.14|-33.42|0.8574
71914161|NCT02712008|143349293|SUPERIORITY||Least square mean difference|-38.9||||0.0351|TWO_SIDED|95.0|-75.06|-2.73||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.||-2.73|-75.06|0.0351
71914162|NCT02712008|143349294|SUPERIORITY||difference in percentages|-1.8||||0.7617|TWO_SIDED|95.0|-13.5|9.8||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||9.8|-13.5|0.7617
71914163|NCT02712008|143349294|SUPERIORITY||difference in percentages|6.1||||0.2268|TWO_SIDED|95.0||16.3||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.||16.3|- 4.1|0.2268
71914164|NCT02712008|143349295|SUPERIORITY||difference in percentages|-1.3||||0.8896|TWO_SIDED|95.0|-20.4|17.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||17.7|-20.4|0.8896
71914165|NCT02712008|143349295|SUPERIORITY||difference in percentages|6.4||||0.5021|TWO_SIDED|95.0|-12.6|25.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||25.5|-12.6|0.5021
71914166|NCT02712008|143349295|SUPERIORITY||difference in percentages|6.0||||0.5273|TWO_SIDED|95.0|-12.8|24.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||24.7|-12.8|0.5273
71870715|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.53|||||TWO_SIDED|95.0|-0.7|-0.36||||||Week 6: Difference in LS Mean change in HbA1c (%) from baseline to Week 6 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.36|-0.70|
71870716|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.34||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 5 mg group and Placebo group||-0.34|-0.76|< 0.0001
71870717|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.68|||<|0.0001|TWO_SIDED|95.0|-0.89|-0.47||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 10 mg group and Placebo group||-0.47|-0.89|< 0.0001
71870718|NCT02390050|143258789|SUPERIORITY||Difference of LS Means|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.01|-0.59||P-value from Type III F-test|ANCOVA|Study center, treatment, visit and a treatment-by-visit interaction as fixed effects; prior anti-diabetic treatment and baseline HbA1c as covariates||Week 12: Difference in LS Mean change in HbA1c (%) from baseline to Week 12 was obtained by comparing Bexagliflozin 20 mg group and Placebo group||-0.59|-1.01|< 0.0001
71683176|NCT05727306|142884375|OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.14|1.87|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.87|1.14|
71870719|NCT01775124|143258809|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||||TWO_SIDED|95.0|-2.95|-0.2|||ANOVA|||Descriptive, no hypothesis||-0.2|-2.95|
71870720|NCT00409773|143258825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-16.5|-9.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-9.8|-16.5|<0.001
71870721|NCT00409773|143258825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.2|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-13.6|-6.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.9|-13.6|<0.001
71870722|NCT00409773|143258825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|1.7|<|0.001||95.0|-11.3|-4.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.6|-11.3|<0.001
71870723|NCT00409773|143258826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-9.6|-4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.8|-9.6|<0.001
71870724|NCT00409773|143258826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.8|-2.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.9|-7.8|<0.001
71870725|NCT00409773|143258826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-6.8|-2.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.0|-6.8|<0.001
71870726|NCT00409773|143258827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.69||95.0|-5.4|3.3|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.3|-5.4|0.690
71870727|NCT00409773|143258827|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.8||||0.2||95.0|-1.6|7.1|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.1|-1.6|0.200
71870728|NCT00409773|143258827|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.4||||0.48||95.0|-4.7|3.9|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||3.9|-4.7|0.480
71870729|NCT00409773|143258828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|1.3||0.013||95.0|0.7|6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.0|0.7|0.013
71870730|NCT00409773|143258828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|1.3||0.378||95.0|-1.5|3.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||3.8|-1.5|0.378
71683177|NCT05727306|142884376|OTHER||Hazard Ratio (HR)|1.49|||||TWO_SIDED|95.0|1.38|1.61|||||Calculated using Cox Proportional Hazard model.Reflects a comparison of incidence rates between participants diagnosed with Alopecia Areata (AA) and those without AA. Adjusted for sociodemographic,clinical characteristics and major comorbidities.|||1.61|1.38|
71683178|NCT04877535|142884426|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.524|TWO_SIDED|95.0|-0.24|0.12|||t-test, 2 sided|||||0.12|-0.24|0.524
71870731|NCT00409773|143258828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|1.3||0.003||95.0|1.3|6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||6.6|1.3|0.003
71870732|NCT00409773|143258829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-13.3|-7.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-7.3|-13.3|<0.001
71870733|NCT00409773|143258829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-10.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-10.2|<0.001
71870734|NCT00409773|143258829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.9|-3.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.9|-9.9|<0.001
71870735|NCT00409773|143258830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|2.6||0.809||95.0|-5.7|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-5.7|0.809
71870736|NCT00409773|143258830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|2.6||0.217||95.0|-1.9|8.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||8.4|-1.9|0.217
71870737|NCT00409773|143258830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|2.6||0.796||95.0|-5.8|4.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.4|-5.8|0.796
71870738|NCT00409773|143258831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-12.1|-6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.6|-12.1|<0.001
71870739|NCT00409773|143258831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.1|-2.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.6|-8.1|<0.001
71870740|NCT00409773|143258831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.0|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.0|<0.001
71870741|NCT00409773|143258832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|1.2||0.042||95.0|0.1|4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.8|0.1|0.042
71870742|NCT00409773|143258832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-0.2|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.5|-0.2|<0.001
71914167|NCT02712008|143349295|SUPERIORITY||difference in percentages|-1.5||||0.8683|TWO_SIDED|95.0|-19.7|16.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||16.6|-19.7|0.8683
71914168|NCT02712008|143349295|SUPERIORITY||difference in percentages|8.8||||0.3546|TWO_SIDED|95.0|-9.8|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.8|0.3546
71914169|NCT02712008|143349295|SUPERIORITY||difference in percentages|0.2||||0.9801|TWO_SIDED|95.0|-19.0|19.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||19.5|-19.0|0.9801
71914170|NCT02712008|143349295|SUPERIORITY||difference in percentages|8.8||||0.3528|TWO_SIDED|95.0|-9.9|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.||27.4|-9.9|0.3528
71914171|NCT00922974|143349299|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Based on the one-sided exact binomial test with α=0.025 and a 2:1 randomization, 228 patients would be required to detect a 40% improvement in the response rate from 51% (external beam radiation therapy) to 70% (Radiosurgery/SBRT) with a statistical power of 0.80.||||0.99
71914172|NCT00922974|143349300|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.38|TWO_SIDED|95.0|0.72|1.27|||Stratified log rank|One-sided significance level = 0.025.|Reference level = Radiosurgery/SBRT|||1.27|0.72|0.38
71914173|NCT00922974|143349301|SUPERIORITY||Hazard Ratio (HR)|1.73||||0.29|TWO_SIDED|95.0|0.24|12.8|||Stratified log rank|One-sided significance level = 0.025|Significance level = Radiosurgery/SBRT|||12.8|0.24|0.29
71914174|NCT00922974|143349302|SUPERIORITY|||||||0.93||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with treatment-related adverse events.||||0.93
71914175|NCT00922974|143349302|SUPERIORITY|||||||0.09||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with any adverse events.||||0.09
71914176|NCT00922974|143349303|SUPERIORITY|||||||0.59||||||Two-sided significance level = 0.05|Gray's test|||||||0.59
71914177|NCT00922974|143349304|SUPERIORITY|||||||0.38||||||Two-sided significance level = 0.05|Gray's test|||||||0.38
71914178|NCT00922974|143349305|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||Assuming that the data are normally distributed, the two sample t-test assuming equal variances will be used to test the hypothesis at the one-sided 0.025 significance level. A mean difference of 7 points represents a clinically meaningful change (CMC). A difference of less than 7 points between the treatment arms will not be considered meaningful, even if it has statistical significance.||||0.28
71914179|NCT00922974|143349306|SUPERIORITY|||||||0.4313|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.4313
71914180|NCT00922974|143349306|SUPERIORITY|||||||0.8707|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.8707
71683179|NCT04877535|142884426|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.403|TWO_SIDED|95.0|-0.4|0.16|||t-test, 2 sided|||||0.16|-0.4|0.403
71870743|NCT00409773|143258832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.2|<|0.001||95.0|-7.0|4.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||4.0|-7.0|<0.001
71870744|NCT00409773|143258833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-11.6|-6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.0|-11.6|<0.001
71870745|NCT00409773|143258833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.2|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.5|-8.2|<0.001
71870746|NCT00409773|143258833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.9|STANDARD_ERROR_OF_MEAN|1.4|<|0.001||95.0|-8.7|-3.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.1|-8.7|<0.001
71914181|NCT00922974|143349306|SUPERIORITY|||||||0.1549|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.1549
71914182|NCT00922974|143349306|SUPERIORITY|||||||0.0193|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.0193
71914183|NCT00922974|143349306|SUPERIORITY|||||||0.0016|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0016
71914184|NCT00922974|143349306|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0003
71914185|NCT00922974|143349306|SUPERIORITY|||||||0.6371|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with BPI Worst Pain Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.6371
71914186|NCT00922974|143349307|SUPERIORITY|||||||0.0218|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.0218
71914187|NCT00922974|143349307|SUPERIORITY|||||||0.9437|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.9437
71914188|NCT00922974|143349307|SUPERIORITY|||||||0.0696|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0696
71914189|NCT00922974|143349307|SUPERIORITY|||||||0.114|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.1140
71914190|NCT00922974|143349307|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||0.0003
71914191|NCT00922974|143349307|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||<0.0001
71914192|NCT00922974|143349307|SUPERIORITY|||||||0.7732|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with EQ-5D Index Score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.7732
71914193|NCT00922974|143349308|SUPERIORITY|||||||0.5198|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Treatment Arm (External Beam Radiation Therapy vs. Radiosurgery/SBRT) is reported here.||||0.5198
71914194|NCT00922974|143349308|SUPERIORITY|||||||0.1197|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Age (\< 63 years vs. ≥ 63 years) is reported here.||||0.1197
71914195|NCT00922974|143349308|SUPERIORITY|||||||0.0306|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Gender (female vs. male) is reported here.||||0.0306
71914196|NCT00922974|143349308|SUPERIORITY|||||||0.7903|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Race (Other vs. while) is reported here.||||0.7903
71914197|NCT00922974|143349308|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Zubrod performance status (0 vs. 1,2) is reported here.||||<0.0001
71914198|NCT00922974|143349308|SUPERIORITY|||||||0.0026|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Taking pain medication (No vs. Yes) is reported here.||||0.0026
71914199|NCT00922974|143349308|SUPERIORITY|||||||0.3282|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A general linear mixed-effect model was run with FACT-G total score (baseline, 3, 6, 12, and 24 months) as the outcome of interest. Age, gender, race, Zubrod performance status, pain medication, tumor type, time, and treatment arm were the covariates considered in each model. Tumor type (radioresistant vs. other) is reported here.||||0.3282
71914200|NCT03950440|143349309|OTHER|Propensity scores were obtained from three separate multivariable logistic regression models contrasting each group versus the two other groups. The result from this multivariable model quantifies the degree of separation between both groups.|Risk Ratio (RR)|0.26|||<|0.0001|TWO_SIDED|95.0|0.16|0.44||The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|Poisson regression||TAVI-group compared to the SAVR-group|Frailty scores (Tilburg and essential) and Euroscore were specified in the protocol. Age was added during the meeting before start of the data-analysis|The double robust approach refers to the weighted analysis with all variables involved in the construction of the propensity-based weights added as confounders in the model.|0.44|0.16|<0.0001
71914201|NCT01957215|143349320|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.72||||0.0201||95.0|0.1134|1.3199||P- value was obtained from ANCOVA model with treatment and site as fixed effects and NRS Baseline value as a covariate|ANCOVA||ADJ DIFF is the Treatment difference defined as the Adjusted Mean of 0.35% Indomethacin Patches minus Adjusted Mean of Placebo Patches|||1.3199|0.1134|0.0201
71914202|NCT02443155|143349338|SUPERIORITY||Treatment ratio|1.48|||=|0.0017|TWO_SIDED|95.0|1.16|1.89|||Mixed model repeated measurements||NNC0114-0006 + liraglutide / Placebo|Ratio of week 54 to baseline are analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.89|1.16|=0.0017
71914203|NCT02443155|143349338|SUPERIORITY||Treatment Ratio|1.23|||=|0.0927|TWO_SIDED|95.0|0.97|1.57|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.57|0.97|=0.0927
71914204|NCT02443155|143349338|SUPERIORITY||Treatment Ratio|1.12|||=|0.378|TWO_SIDED|95.0|0.87|1.42|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.42|0.87|=0.3780
71914205|NCT02443155|143349338|SUPERIORITY||Treatment ratio|1.2|||=|0.1377|TWO_SIDED|95.0|0.94|1.53|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.53|0.94|=0.1377
71870747|NCT00409773|143258834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-17.6|-10.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-10.5|-17.6|<0.001
71870748|NCT00409773|143258834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-13.2|-6.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-6.1|-13.2|<0.001
71870749|NCT00409773|143258834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-12.0|-4.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.9|-12.0|<0.001
71870750|NCT00409773|143258835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-14.0|-8.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.0|-14.0|<0.001
71870751|NCT00409773|143258835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-9.4|-3.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.3|-9.4|<0.001
71870752|NCT00409773|143258835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|1.5|<|0.001||95.0|-8.7|-2.7|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-2.7|-8.7|<0.001
71870753|NCT00409773|143258836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.5|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.0|-8.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-8.1|-15.0|<0.001
71870754|NCT00409773|143258836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-10.4|-3.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-3.6|-10.4|<0.001
71870755|NCT00409773|143258836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.7|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-11.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum||||-4.3|-11.2|<0.001
71870756|NCT00409773|143258839|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-2.9||||0.42||95.0|-11.0|5.0|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||5.0|-11.0|0.420
71870757|NCT00409773|143258839|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.9||||0.555||95.0|-9.5|7.2|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||7.2|-9.5|0.555
71870758|NCT00409773|143258839|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|2.3||||0.41||95.0|-5.1|9.6|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum||||9.6|-5.1|0.410
71870759|NCT00153062|143258840|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin of 1.075|Hazard Ratio (HR)|1.01||||0.783|TWO_SIDED|95.0|0.92|1.11|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs clopidogrel||1.11|0.92|0.7830
71870760|NCT00153062|143258841|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8292|TWO_SIDED|95.0|0.92|1.07|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs Clopidogrel||1.07|0.92|0.8292
71870761|NCT00153062|143258842|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.1073|TWO_SIDED|95.0|0.87|1.01|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.||Telmisartan vs Placebo||1.01|0.87|0.1073
71870762|NCT00153062|143258843|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1007|TWO_SIDED|95.0|0.65|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates||Telmisartan vs Placebo||1.04|0.65|0.1007
71870763|NCT00153062|143258844|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2312|TWO_SIDED|95.0|0.86|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates||Telmisartan vs placebo||1.04|0.86|0.2312
71870764|NCT01919814|143258858|SUPERIORITY||||||>|0.05||||||Threshold P-Value was 0.05|t-test, 2 sided|||||||>0.05
71870765|NCT00275262|143258862|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.125
71870766|NCT00275262|143258863|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.||||0.299
71870767|NCT02164383|143258868|SUPERIORITY||Mean Difference (Final Values)|1.82||||0.85|TWO_SIDED||||||ANOVA||ANOVA results: F(1,28)=.04, p=.85, partial eta-squared (as a measure of effect size) = .001|||||.85
71870768|NCT02831387|143258902|SUPERIORITY||Mean Difference (Net)|-1.88||||0.749|TWO_SIDED|95.0|-13.696|9.936|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in the Subject Reported Dry Eye Questionnaire||9.936|-13.696|0.749
71870769|NCT02831387|143258903|SUPERIORITY||Mean Difference (Net)|-6.6||||0.267|TWO_SIDED|95.0|-18.4|5.3|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Frequency Scores||5.3|-18.4|0.267
71870770|NCT02831387|143258904|SUPERIORITY||Mean Difference (Net)|3.9||||0.495|TWO_SIDED|95.0|-7.6|15.4|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Severity Scores||15.4|-7.6|0.495
71870771|NCT02831387|143258905|SUPERIORITY||Mean Difference (Net)|0.6||||0.316|TWO_SIDED|95.0|-0.6|1.9|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Fluorescein Staining of the Cornea||1.9|-0.6|0.316
71870772|NCT02831387|143258906|SUPERIORITY||Mean Difference (Net)|-0.2||||0.823|TWO_SIDED|95.0|-1.9|1.5|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva||1.5|-1.9|0.823
71870773|NCT02831387|143258907|SUPERIORITY||Odds Ratio (OR)|1.923|||||TWO_SIDED|95.0|0.515|7.184||||||Statistical Analysis 1 for the Number of participants with at least 20% improvement in symptoms from baseline to Day 29||7.184|0.515|
71870774|NCT02831387|143258908|SUPERIORITY||Mean Difference (Net)|1.666||||0.723|TWO_SIDED|95.0|-7.759|11.092|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score||11.092|-7.759|0.723
71870775|NCT00666679|143258956|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.05||||0.033||95.0|0.0|0.09|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.09|0.00|0.033
71870776|NCT00666679|143258957|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.15||||0.005||95.0|-0.26|-0.05|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.05|-0.26|0.005
71870777|NCT00666679|143258958|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.09||||0.015||95.0|-0.17|-0.02|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||-0.02|-0.17|0.015
71870778|NCT00666679|143258959|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.6||||0.073||95.0|-1.26|0.06|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.06|-1.26|0.073
71870779|NCT00666679|143258960|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|6.08||||0.004||95.0|1.94|10.23|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|Least-Squares Means for average percentage of days are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|||10.23|1.94|0.004
71870780|NCT00666679|143258961|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-5.43|||<=|0.001||95.0|-8.67|-2.19|||ANCOVA|Model with terms for patient, treatment and period.|Least-Squares Means for percentage of days are derived from ANCOVA model with terms for patient, treatment and period.|||-2.19|-8.67|<=0.001
71870781|NCT00666679|143258962|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|-0.07||||0.013||95.0|-0.12|-0.01|||Mixed Models Analysis|Model with fixed effects for treatment, period and baseline covariate.|Least-Squares Means for change from baseline are derived from mixed model with terms for treatment, period and baseline covariate.|||-0.01|-0.12|0.013
71870782|NCT00666679|143258963|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least-Squares Means|0.08||||0.002||95.0|0.03|0.13|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|||0.13|0.03|0.002
71870783|NCT05062759|143258973|OTHER||Geometric Least square (LS) mean ratio|0.65|||||TWO_SIDED|90.0|0.43|0.98||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model.||0.98|0.43|
71870784|NCT05062759|143258973|OTHER||Geometeric LS mean ratio|0.83|||||TWO_SIDED|90.0|0.6|1.15||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.15|0.60|
71870785|NCT05062759|143258973|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.71|1.37||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.37|0.71|
71870786|NCT05062759|143258974|OTHER||Geometeric LS mean ratio|0.73|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
71870787|NCT05062759|143258974|OTHER||Geometeric LS mean ratio|1.25|||||TWO_SIDED|90.0|0.72|2.17||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.17|0.72|
71914206|NCT02443155|143349338|SUPERIORITY||Treatment ratio|1.33|||=|0.0214|TWO_SIDED|95.0|1.04|1.69|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.69|1.04|=0.0214
71914207|NCT02443155|143349338|SUPERIORITY||Treatmrnt ratio|1.1|||=|0.4187|TWO_SIDED|95.0|0.87|1.41|||Mixed model repeated measurements|||Ratio of week 54 to baseline are analysed using MMRM with an unstructured covariance matrix. Treatment, stratum and sex as factors and log baseline value and age as covariates, including the interaction between visit and all variables.||1.41|0.87|=0.4187
71914208|NCT00106249|143349520|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71870788|NCT05062759|143258974|OTHER||Geometric LS mean ratio|1.23|||||TWO_SIDED|90.0|0.73|2.07||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||2.07|0.73|
71870789|NCT05062759|143258974|OTHER||Geometeric LS mean ratio|0.89|||||TWO_SIDED|90.0|0.54|1.48||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.48|0.54|
71870790|NCT05062759|143258975|OTHER||Geometeric LS mean ratio|0.74|||||TWO_SIDED|90.0|0.52|1.04||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.04|0.52|
71870791|NCT05062759|143258975|OTHER||Geometeric LS mean ratio|0.96|||||TWO_SIDED|90.0|0.72|1.29||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.29|0.72|
71870792|NCT05062759|143258975|OTHER||Geometric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.73|1.46||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.46|0.73|
71870793|NCT05062759|143258976|OTHER||Geometeric LS mean ratio|0.79|||||TWO_SIDED|90.0|0.51|1.25||||||Influenza A H1N1 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.25|0.51|
71870794|NCT05062759|143258976|OTHER||Geometeric LS mean ratio|0.76|||||TWO_SIDED|90.0|0.42|1.28||||||Influenza A H3N2 Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.28|0.42|
71870795|NCT05062759|143258976|OTHER||Geometric LS mean ratio|0.99|||||TWO_SIDED|90.0|0.49|1.99||||||Influenza B Victoria Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.99|0.49|
71914209|NCT00106249|143349521|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71683180|NCT04877535|142884427|SUPERIORITY||Odds Ratio (OR)|1.05||||1|TWO_SIDED|95.0|0.47|2.38|||Fisher Exact|||||2.38|0.47|1.00
71870796|NCT05062759|143258976|OTHER||Geometeric LS mean ratio|1.03|||||TWO_SIDED|90.0|0.7|1.52||||||Influenza B Yamagata Lineage Ratio of placebo over tezepelumab. Results based on ANCOVA model||1.52|0.70|
71870797|NCT03486457|143259036|SUPERIORITY||Difference in percentage of participants|32.35|STANDARD_ERROR_OF_MEAN|5.05|<|0.0001|TWO_SIDED|95.0|22.45|42.25|||Normal approximation|||The normal approximation to the difference in binomial proportions was used to test the difference between tofacitinib 5 mg BID and placebo and to generate 95% CI and p-value for the difference in response rates.||42.25|22.45|<0.0001
71870798|NCT03486457|143259037|SUPERIORITY||Difference in percentage of participants|15.44|STANDARD_ERROR_OF_MEAN|4.79||0.0013|TWO_SIDED|95.0|6.05|24.83|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.83|6.05|0.0013
71870799|NCT03486457|143259037|SUPERIORITY||Difference in percentage of participants|30.15|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|95.0|19.53|40.76|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.76|19.53|<0.0001
71870800|NCT03486457|143259037|SUPERIORITY||Difference in percentage of participants|51.47|STANDARD_ERROR_OF_MEAN|5.56|<|0.0001|TWO_SIDED|95.0|40.57|62.37|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||62.37|40.57|<0.0001
71870801|NCT03486457|143259037|SUPERIORITY||Difference in percentage of participants|36.76|STANDARD_ERROR_OF_MEAN|6.81|<|0.0001|TWO_SIDED|95.0|23.41|50.12|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||50.12|23.41|<0.0001
71870802|NCT03486457|143259037|SUPERIORITY||Difference in percentage of participants|24.26|STANDARD_ERROR_OF_MEAN|7.21||0.0008|TWO_SIDED|95.0|10.14|38.39|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||38.39|10.14|0.0008
71870803|NCT03486457|143259037|SUPERIORITY||Difference in percentage of participants|13.97|STANDARD_ERROR_OF_MEAN|7.08||0.0486|TWO_SIDED|95.0|0.09|27.85|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||27.85|0.09|0.0486
71870804|NCT03486457|143259038|SUPERIORITY||Difference in percentage of participants|1.1|STANDARD_ERROR_OF_MEAN|1.53||0.473|TWO_SIDED|95.0|-1.9|4.1|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||4.10|-1.90|0.4730
71870805|NCT03486457|143259038|SUPERIORITY||Difference in percentage of participants|1.83|STANDARD_ERROR_OF_MEAN|1.69||0.2792|TWO_SIDED|95.0|-1.48|5.14|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||5.14|-1.48|0.2792
71870806|NCT03486457|143259038|SUPERIORITY||Difference in percentage of participants|7.35|STANDARD_ERROR_OF_MEAN|2.84||0.0095|TWO_SIDED|95.0|1.79|12.91|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||12.91|1.79|0.0095
71870807|NCT03486457|143259038|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|3.37|<|0.0001|TWO_SIDED|95.0|6.63|19.84|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||19.84|6.63|<0.0001
71870808|NCT03486457|143259038|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|4.69||0.0048|TWO_SIDED|95.0|4.03|22.44|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.44|4.03|0.0048
71870809|NCT03486457|143259038|SUPERIORITY||Difference in percentage of participants|13.24|STANDARD_ERROR_OF_MEAN|6.6||0.0449|TWO_SIDED|95.0|0.3|26.17|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.17|0.30|0.0449
71870810|NCT03486457|143259039|SUPERIORITY||Difference in percentage of participants|2.94|STANDARD_ERROR_OF_MEAN|2.29||0.1985|TWO_SIDED|95.0|-1.54|7.42|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||7.42|-1.54|0.1985
71870811|NCT03486457|143259039|SUPERIORITY||Difference in percentage of participants|8.09|STANDARD_ERROR_OF_MEAN|2.91||0.0055|TWO_SIDED|95.0|2.38|13.8|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||13.80|2.38|0.0055
71870812|NCT03486457|143259039|SUPERIORITY||Difference in percentage of participants|27.21|STANDARD_ERROR_OF_MEAN|4.44|<|0.0001|TWO_SIDED|95.0|18.51|35.9|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||35.90|18.51|<0.0001
71870813|NCT03486457|143259039|SUPERIORITY||Difference in percentage of participants|22.06|STANDARD_ERROR_OF_MEAN|6.37||0.0005|TWO_SIDED|95.0|9.58|34.54|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||34.54|9.58|0.0005
71870814|NCT03486457|143259039|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.24||0.0111|TWO_SIDED|95.0|4.2|32.57|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.57|4.20|0.0111
71870815|NCT03486457|143259040|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.044||0.0097|TWO_SIDED|95.0|-0.2|-0.03|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.03|-0.20|0.0097
71870816|NCT03486457|143259040|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.045||0.0043|TWO_SIDED|95.0|-0.22|-0.04|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.04|-0.22|0.0043
71870817|NCT03486457|143259040|SUPERIORITY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|-0.3|-0.11|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.30|<0.0001
71870818|NCT03486457|143259040|SUPERIORITY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.053|<|0.0001|TWO_SIDED|95.0|-0.32|-0.11|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.11|-0.32|<0.0001
71870819|NCT03486457|143259040|SUPERIORITY||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.046||0.0535|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.18|0.0535
71870820|NCT03486457|143259040|SUPERIORITY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.044||0.094|TWO_SIDED|95.0|-0.16|0.01|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.16|0.0940
71870821|NCT03486457|143259041|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
71870822|NCT03486457|143259041|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
71870823|NCT03486457|143259041|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
71870824|NCT03486457|143259041|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
71870825|NCT03486457|143259041|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
71870826|NCT03486457|143259041|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
71870827|NCT03486457|143259042|SUPERIORITY||Difference in percentage of participants|13.07|STANDARD_ERROR_OF_MEAN|8.56||0.127|TWO_SIDED|95.0|-3.72|29.85|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.85|-3.72|0.1270
71870828|NCT03486457|143259042|SUPERIORITY||Difference in percentage of participants|4.02|STANDARD_ERROR_OF_MEAN|9.23||0.6634|TWO_SIDED|95.0|-14.07|22.1|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||22.10|-14.07|0.6634
71870829|NCT03486457|143259042|SUPERIORITY||Difference in percentage of participants|21.78|STANDARD_ERROR_OF_MEAN|9.46||0.0214|TWO_SIDED|95.0|3.23|40.33|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.33|3.23|0.0214
71870830|NCT03486457|143259042|SUPERIORITY||Difference in percentage of participants|24.03|STANDARD_ERROR_OF_MEAN|9.46||0.011|TWO_SIDED|95.0|5.5|42.57|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||42.57|5.50|0.0110
71870831|NCT03486457|143259042|SUPERIORITY||Difference in percentage of participants|12.57|STANDARD_ERROR_OF_MEAN|9.58||0.1896|TWO_SIDED|95.0|-6.21|31.36|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||31.36|-6.21|0.1896
71870832|NCT03486457|143259042|SUPERIORITY||Difference in percentage of participants|6.83|STANDARD_ERROR_OF_MEAN|8.97||0.4466|TWO_SIDED|95.0|-10.75|24.41|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||24.41|-10.75|0.4466
71683181|NCT04877535|142884428|SUPERIORITY||Odds Ratio (OR)|4.3|||<|0.001|TWO_SIDED|95.0|1.81|11.13|||Fisher Exact|||||11.13|1.81|<0.001
71870833|NCT03486457|143259043|SUPERIORITY||LS mean difference|-2.7|STANDARD_ERROR_OF_MEAN|0.633|<|0.0001|TWO_SIDED|95.0|-3.95|-1.45|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.45|-3.95|<0.0001
71870834|NCT03486457|143259043|SUPERIORITY||LS mean difference|-3.79|STANDARD_ERROR_OF_MEAN|0.711|<|0.0001|TWO_SIDED|95.0|-5.2|-2.39|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.39|-5.20|<0.0001
71914210|NCT02037204|143349541|NON_INFERIORITY|A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|||||<|0.05|||||||ANOVA|||A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.||||<0.05
71914211|NCT00524043|143349544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|4.2||0.504||95.0|-5.47|11.09||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Sample size estimation was based on the assumption that the difference between the paliperidone ER 1.5 mg dose group and the placebo group in the mean change in PANSS total score from baseline to end point was 11 points with a within-group standard deviation of 20 points. It was calculated that 65 patients were needed per treatment group to detect a statistically significant treatment difference between the paliperidone ER 1.5 mg dose group and the placebo group with a power of 87.5%.||11.09|-5.47|0.504
71914212|NCT00524043|143349544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|4.15||0.431||95.0|-11.46|4.9||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|Paliperidone ER 6 mg was used for assay sensitivity||||4.90|-11.46|0.431
71914213|NCT00524043|143349545|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||Based on ANCOVA model on ranks with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.626
71914214|NCT00524043|143349546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|2.69||0.87||95.0|-4.86|5.74||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||5.74|-4.86|0.870
71914215|NCT00524043|143349547|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.126
71914216|NCT00524043|143349548|SUPERIORITY_OR_OTHER|||||||0.691||95.0||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||||||0.691
71914217|NCT01665872|143349598|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.172|||||||t-test, 2 sided|||||||0.172
71914218|NCT01665872|143349599|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.5337|||||||Wilcoxon (Mann-Whitney)|||Are CES-D scores at 12 months different between groups?||||0.5337
71914219|NCT01665872|143349600|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.092||||||This test looks at a difference in Parental Distress at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0920
71914220|NCT01665872|143349600|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.3352||||||This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.3352
71914221|NCT01665872|143349600|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0404||||||This test looks at a difference in Difficult Child at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0404
71683182|NCT04877535|142884428|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.23|4.19|||Fisher Exact|||||4.19|0.23|1.00
71914222|NCT01665872|143349600|EQUIVALENCE|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0915||||||This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)|||||||0.0915
71914223|NCT01665872|143349601|EQUIVALENCE|Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.||||||0.2914|||||||Chi-squared|||||||0.2914
71914224|NCT02773368|143349603|NON_INFERIORITY|Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.|Treatment Contrast|-0.34|||||TWO_SIDED|95.0|-0.48|-0.2|||ANCOVA||IDegLira minus IGlar|Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.||-0.20|-0.48|
71870835|NCT03486457|143259043|SUPERIORITY||LS mean difference|-4.89|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001|TWO_SIDED|95.0|-6.39|-3.39|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.39|-6.39|<0.0001
71683183|NCT04877535|142884429|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|1.94|39.25|||Fisher Exact|||||39.25|1.94|<0.001
71683184|NCT04877535|142884429|SUPERIORITY||Odds Ratio (OR)|1.63||||0.63|TWO_SIDED|95.0|0.13|14.86|||Fisher Exact|||||14.86|0.13|0.630
71870836|NCT03486457|143259043|SUPERIORITY||LS mean difference|-5.85|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.53|-4.17|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.17|-7.53|<0.0001
71870837|NCT03486457|143259043|SUPERIORITY||LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|0.583|<|0.0001|TWO_SIDED|95.0|-4.35|-2.04|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.04|-4.35|<0.0001
71870838|NCT03486457|143259043|SUPERIORITY||LS mean difference|-2.59|STANDARD_ERROR_OF_MEAN|0.668||0.0002|TWO_SIDED|95.0|-3.91|-1.27|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.27|-3.91|0.0002
71870839|NCT03486457|143259044|SUPERIORITY||LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.012||0.001|TWO_SIDED|95.0|-5.4|-1.4|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.40|-5.40|0.0010
71870840|NCT03486457|143259044|SUPERIORITY||LS mean difference|-5.03|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-7.05|-3.01|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.01|-7.05|<0.0001
71870841|NCT03486457|143259044|SUPERIORITY||LS mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-7.7|-3.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.66|-7.70|<0.0001
71870842|NCT03486457|143259044|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|1.111|<|0.0001|TWO_SIDED|95.0|-9.2|-4.82|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.82|-9.20|<0.0001
71870843|NCT03486457|143259044|SUPERIORITY||LS mean difference|-3.95|STANDARD_ERROR_OF_MEAN|1.073||0.0003|TWO_SIDED|95.0|-6.07|-1.83|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.83|-6.07|0.0003
71870844|NCT03486457|143259044|SUPERIORITY||LS mean difference|-2.39|STANDARD_ERROR_OF_MEAN|1.108||0.0323|TWO_SIDED|95.0|-4.58|-0.2|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.20|-4.58|0.0323
71870845|NCT03486457|143259045|SUPERIORITY||LS mean difference|-6.57|STANDARD_ERROR_OF_MEAN|2.481||0.0087|TWO_SIDED|95.0|-11.46|-1.68|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.68|-11.46|0.0087
71914225|NCT02773368|143349603|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.|Treatment Contrast|-0.36|||||TWO_SIDED|95.0|-0.5|-0.21|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-0.21|-0.50|
71914226|NCT02773368|143349604|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.|Treatment Contrast|-1.92|||||TWO_SIDED|95.0|-2.64|-1.19|||ANCOVA||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-1.19|-2.64|
71914227|NCT02773368|143349605|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.|Treatment Ratio|0.42|||||TWO_SIDED|95.0|0.23|0.75|||Negative binomial regression model||IDegLira over IGlar|This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).||0.75|0.23|
71914228|NCT02773368|143349606|SUPERIORITY|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.|Treatment Contrast|-15.37|||||TWO_SIDED|95.0|-19.6|-11.13|||ANCOVA||IDegLira minus IGlar|The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.||-11.13|-19.60|
71683185|NCT05079230|142884462|SUPERIORITY||Hazard Ratio (HR)|1.178||||0.3276|TWO_SIDED|95.0|0.848|1.637|||stratified log-rank test|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.637|0.848|0.3276
71870846|NCT03486457|143259045|SUPERIORITY||LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|2.487|<|0.0001|TWO_SIDED|95.0|-16.6|-6.79|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.79|-16.60|<0.0001
71870847|NCT03486457|143259045|SUPERIORITY||LS mean difference|-16.14|STANDARD_ERROR_OF_MEAN|2.796|<|0.0001|TWO_SIDED|95.0|-21.66|-10.63|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.63|-21.66|<0.0001
71870848|NCT03486457|143259045|SUPERIORITY||LS mean difference|-21.87|STANDARD_ERROR_OF_MEAN|3.027|<|0.0001|TWO_SIDED|95.0|-27.84|-15.9|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.90|-27.84|<0.0001
71870849|NCT03486457|143259045|SUPERIORITY||LS mean difference|-6.94|STANDARD_ERROR_OF_MEAN|2.865||0.0163|TWO_SIDED|95.0|-12.6|-1.29|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.29|-12.60|0.0163
71914229|NCT01929018|143349636|SUPERIORITY|||||||0.87|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.87
71914230|NCT01929018|143349636|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.38
71914231|NCT01929018|143349637|SUPERIORITY|||||||0.75|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.75
71914232|NCT01929018|143349637|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.11
71914233|NCT01929018|143349638|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.11
71914234|NCT01929018|143349638|SUPERIORITY|||||||0.23|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.23
71914235|NCT01929018|143349639|SUPERIORITY|||||||0.27|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.27
71914236|NCT01929018|143349639|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.58
71914237|NCT01929018|143349640|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.83
71914238|NCT01929018|143349640|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.13
71914239|NCT01929018|143349641|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
71914240|NCT01929018|143349641|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.02
71914241|NCT01929018|143349642|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.03
71914242|NCT01929018|143349642|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.06
71914243|NCT01929018|143349643|SUPERIORITY|||||||0.62|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.62
71914244|NCT01929018|143349643|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.40
71914245|NCT01929018|143349644|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.||||0.96
71914246|NCT01929018|143349644|SUPERIORITY|||||||0.35|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.||||0.35
71914247|NCT01366534|143349645|OTHER||Vaccine Efficacy Maentel-Haenzel Method|-17.6||||0.7675|TWO_SIDED|95.0|-107.4|33.3|||2-sided Fisher Exact test||Pre-defined futility criteria for efficacy: point estimate of increase of VE in Ad35.CS.01 Group over GSK257049 Group less than 0%|Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||33.3|-107.4|0.7675
71914248|NCT01366534|143349645|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|44.0||||0.0066|TWO_SIDED|95.0|20.7|60.4|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||60.4|20.7|0.0066
71914249|NCT01366534|143349645|OTHER||Vaccine Efficacy: Maentel-Haenzel Method|52.4||||0.0021|TWO_SIDED|95.0|25.4|69.6|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.||69.6|25.4|0.0021
71914250|NCT01789255|143349668|OTHER|||||||0.02642|||||||Wilcoxon (Mann-Whitney)|||||||0.02642
71914251|NCT01789255|143349669|OTHER|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||||||0.028
71914252|NCT02635867|143349670|SUPERIORITY|Descriptive data and rates of success were calculated independently for indirect and direct therapies. Statistical analyses of proportions were done using Fisher's test and 95% confidence intervals (CI)|||||>|0.1|||||||Fisher Exact|||"The clinical outcome measures assessed were pain using visual analog pain scale, pulp vitality assessment at 12 months.~The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital:~Vital: palpation = negative/ percussion = negative/ response to cold stimuli= positive response Non vital: palpation = positive / percussion = positive. / response to cold stimuli= positive or delayed response time in seconds and lingering."||||>0.1
71914253|NCT02565576|143349672|SUPERIORITY||estimate of contrast posterior median|-1.14|||||TWO_SIDED|90.0|-3.41|1.14|||bayesian|||Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.||1.14|-3.41|
71914254|NCT03185819|143349723|SUPERIORITY||Difference of LS Means|-5.8|STANDARD_ERROR_OF_MEAN|2.74|=|0.037|TWO_SIDED|95.0|-11.19|-0.35||Threshold for significance for p-value was 0.05.|ANCOVA|||A pooled (54 mg and 84 mg) sequential multiple testing procedure was implemented to control type I error by comparing pooled data against midazolam + placebo matched to esketamine nasal spray.||-0.35|-11.19|= 0.037
71914255|NCT03185819|143349723|SUPERIORITY||Difference of LS Mean|-5.7|STANDARD_ERROR_OF_MEAN|3.65|=|0.123|TWO_SIDED|95.0|-12.91|1.55||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (84 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||1.55|-12.91|= 0.123
71914256|NCT03185819|143349723|SUPERIORITY||Difference of LS Means|-5.9|STANDARD_ERROR_OF_MEAN|3.23|=|0.072|TWO_SIDED|95.0|-12.25|0.53||Threshold for significance for p-value was 0.05.|ANCOVA|||Individual esketamine dose (56 mg versus medazolam + esketamine matched placebo) independent testing was planned to be performed after pooled (56 mg + 84 mg) analysis.||0.53|-12.25|= 0.072
71914257|NCT03185819|143349723|SUPERIORITY||Difference of LS Means|-2.4|STANDARD_ERROR_OF_MEAN|3.35|||TWO_SIDED|95.0|-9.08|4.19||||||||4.19|-9.08|
71914258|NCT03375203|143349735|OTHER||Back-transformed Least Square Mean Ratio|0.88|||=|0.346|TWO_SIDED|90.0|0.7|1.1|||ANCOVA|||||1.10|0.70|= 0.346
71870850|NCT03486457|143259045|SUPERIORITY||LS mean difference|-3.1|STANDARD_ERROR_OF_MEAN|2.967||0.2977|TWO_SIDED|95.0|-8.95|2.76|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.76|-8.95|0.2977
71870851|NCT03486457|143259046|SUPERIORITY||LS mean difference|-6.15|STANDARD_ERROR_OF_MEAN|2.646||0.0211|TWO_SIDED|95.0|-11.37|-0.93|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.93|-11.37|0.0211
71914259|NCT03375203|143349735|OTHER||Back-transformed Least Square Mean Ratio|0.64|||=|0.001|TWO_SIDED|90.0|0.51|0.81|||ANCOVA|||||0.81|0.51|= 0.001
71914260|NCT03375203|143349735|OTHER||Back-transformed Least Square Mean Ratio|0.51|||<|0.001|TWO_SIDED|90.0|0.41|0.64|||ANCOVA|||||0.64|0.41|< 0.001
71914261|NCT03375203|143349735|OTHER|||||||0|||||||MCP-mod|||||||0.000
71914262|NCT03321526|143349782|SUPERIORITY|||||||0.5355|TWO_SIDED||||||Log Rank|||||||0.5355
71914263|NCT04254796|143349827|OTHER|Calculation of the effect size (Cohen's d)|Cohen's d|0.27|||||TWO_SIDED|95.0|-0.13|0.68||||||The goal of the analysis was to measure the effect size of the change in the primary mechanistic outcome (Putamen structural node strength), with a Go/No-Go threshold of Cohen's d \> 0.20.||0.68|-0.13|
71914264|NCT01704976|143349835|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71914265|NCT01704976|143349836|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71914266|NCT01704976|143349837|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71914267|NCT01704976|143349838|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71914268|NCT01704976|143349839|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71914269|NCT00329784|143349840|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71914270|NCT00329784|143349840|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
71914271|NCT00329784|143349841|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71914272|NCT00329784|143349842|SUPERIORITY_OR_OTHER|||||||0.369|||||||Wilcoxon (Mann-Whitney)|||||||0.369
71914273|NCT00329784|143349843|SUPERIORITY_OR_OTHER|||||||0.642|||||||Chi-squared|||||||0.642
71914274|NCT00329784|143349844|SUPERIORITY_OR_OTHER|||||||0.417|||||||Chi-squared|||Comparison for Seasonal Rhinoconjunctivitis||||0.417
71870852|NCT03486457|143259046|SUPERIORITY||LS mean difference|-13.08|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|95.0|-18.59|-7.58|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.58|-18.59|<0.0001
71870853|NCT03486457|143259046|SUPERIORITY||LS mean difference|-13.16|STANDARD_ERROR_OF_MEAN|2.928|<|0.0001|TWO_SIDED|95.0|-18.93|-7.38|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-7.38|-18.93|<0.0001
71870854|NCT03486457|143259046|SUPERIORITY||LS mean difference|-18.77|STANDARD_ERROR_OF_MEAN|3.187|<|0.0001|TWO_SIDED|95.0|-25.06|-12.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.49|-25.06|<0.0001
71914275|NCT00329784|143349844|SUPERIORITY_OR_OTHER|||||||0.926|||||||Chi-squared|||Comparison for Perennial Rhinoconjunctivitis||||0.926
71914276|NCT00329784|143349845|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison for Peanut Wheal||||<0.001
71914277|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.361|||||||Chi-squared|||Comparison for Egg Wheal||||0.361
71914278|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.76|||||||Chi-squared|||Comparison for Milk Wheal||||0.760
71914279|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.834|||||||Chi-squared|||Comparison for Sesame Wheal||||0.834
71914280|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.882|||||||Chi-squared|||Comparison for Brazil Nut Wheal||||0.882
71914281|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.226|||||||Chi-squared|||Comparison for Hazel Nut Wheal||||0.226
71914282|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.024|||||||Chi-squared|||Comparison for Cashew Wheal||||0.024
71914283|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.204|||||||Chi-squared|||Comparison for Walnut Wheal||||0.204
71914284|NCT00329784|143349845|SUPERIORITY_OR_OTHER|||||||0.194|||||||Chi-squared|||Comparison for Almond Wheal||||0.194
71914285|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.859|||||||Chi-squared|||Comparison for Peanut IgE||||0.859
71914286|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.885|||||||Chi-squared|||Comparison for Egg IgE||||0.885
71914287|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.403|||||||Chi-squared|||Comparison for Milk IgE||||0.403
71914288|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.106|||||||Chi-squared|||Comparison for Sesame IgE||||0.106
71914289|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.202|||||||Chi-squared|||Comparison for Brazil Nut IgE||||0.202
71914290|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.108|||||||Chi-squared|||Comparison for Hazel Nut IgE||||0.108
71914291|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.157|||||||Chi-squared|||Comparison for Cashew IgE||||0.157
71914292|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||Comparison for Walnut IgE||||0.040
71914293|NCT00329784|143349846|SUPERIORITY_OR_OTHER|||||||0.262|||||||Chi-squared|||Comparison for Almond IgE||||0.262
71914294|NCT00654420|143349848|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.268|TWO_SIDED|95.0|0.47|1.57|||Finkelstein Proportional Hazards Model|||Finkelstein proportional hazards model for interval-censored data was used to assess treatment effect on PFS in Phase II. The hazard ratio with 95% confidence interval for the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported.||1.57|0.47|0.268
71914295|NCT00654420|143349849|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.44||||0.879|TWO_SIDED|95.0|0.78|2.64|||Regression, Cox|||The treatment difference in survival between treatment groups was assessed by Cox regression. The estimated hazard ratio for treatment of the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported from the Cox model.||2.64|0.78|0.879
71914296|NCT00654420|143349850|SUPERIORITY_OR_OTHER||Difference in Percentage|-2.8||||0.721|TWO_SIDED|95.0|-15.9|9.4|||Miettinen & Nurminen Method|||Miettinen and Nurminen's method for stratified data was used for comparison of percentage of participants with objective response (ORR) between the two treatment groups. Response rate calculation was based on full follow-up.||9.4|-15.9|0.721
71914297|NCT00838383|143349853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-70.0||||0.5307|TWO_SIDED|95.0|-291.3|151.4|||ANCOVA|||||151.4|-291.3|0.5307
71914298|NCT00838383|143349853|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-73.2||||0.5121|TWO_SIDED|95.0|-294.5|148.2|||ANCOVA|||||148.2|-294.5|0.5121
71914299|NCT00838383|143349854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-123.1||||0.2735|TWO_SIDED|95.0|-345.5|99.3|||ANCOVA|||||99.3|-345.5|0.2735
71914300|NCT00838383|143349854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-174.5||||0.1223|TWO_SIDED|95.0|-396.8|47.9|||ANCOVA|||||47.9|-396.8|0.1223
71914301|NCT00838383|143349855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-66.6||||0.5505|TWO_SIDED|95.0|-288.0|154.8|||ANCOVA|||||154.8|-288.0|0.5505
71914302|NCT00838383|143349855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-110.3||||0.3237|TWO_SIDED|95.0|-331.7|111.0|||ANCOVA|||||111.0|-331.7|0.3237
71914303|NCT00838383|143349856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-166.5||||0.1412|TWO_SIDED|95.0|-389.6|56.6|||ANCOVA|||||56.6|-389.6|0.1412
71914304|NCT00838383|143349856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-199.8||||0.0813|TWO_SIDED|95.0|-425.0|25.5|||ANCOVA|||||25.5|-425.0|0.0813
71914305|NCT01449955|143349910|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||ANOVA comparing the results of change over time (e.g., comparing baseline to 1 month posttreatment) as well as comparing differences between condition (e.g., placebo compared to rapamycin).||||>0.05
71914306|NCT01449955|143349911|SUPERIORITY||||||>|0.5|||||||ANOVA|||||||> 0.5
71914307|NCT01449955|143349912|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
71914308|NCT01449955|143349913|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
71914309|NCT01449955|143349914|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||< .05
71914310|NCT01449955|143349915|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||> .05
71914311|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|54.2|||||TWO_SIDED|95.0|-41.7|150.1||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 5||150.1|-41.7|
71914312|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|-52.0|||||TWO_SIDED|95.0|-148.5|44.5||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 5||44.5|-148.5|
71914313|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|5.5|||||TWO_SIDED|95.0|-96.0|106.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 5||106.9|-96.0|
71870855|NCT03486457|143259046|SUPERIORITY||LS mean difference|-7.01|STANDARD_ERROR_OF_MEAN|2.827||0.014|TWO_SIDED|95.0|-12.59|-1.43|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-1.43|-12.59|0.0140
71870856|NCT03486457|143259046|SUPERIORITY||LS mean difference|-5.14|STANDARD_ERROR_OF_MEAN|2.931||0.0811|TWO_SIDED|95.0|-10.93|0.64|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.64|-10.93|0.0811
71870857|NCT03486457|143259047|SUPERIORITY||LS mean difference|-9.64|STANDARD_ERROR_OF_MEAN|1.939|<|0.0001|TWO_SIDED|95.0|-13.46|-5.81|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.81|-13.46|<0.0001
71870858|NCT03486457|143259047|SUPERIORITY||LS mean difference|-9.52|STANDARD_ERROR_OF_MEAN|2.305|<|0.0001|TWO_SIDED|95.0|-14.07|-4.98|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-4.98|-14.07|<0.0001
71870859|NCT03486457|143259047|SUPERIORITY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|2.472|<|0.0001|TWO_SIDED|95.0|-21.85|-12.1|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.10|-21.85|<0.0001
71870860|NCT03486457|143259047|SUPERIORITY||LS mean difference|-18.42|STANDARD_ERROR_OF_MEAN|2.506|<|0.0001|TWO_SIDED|95.0|-23.36|-13.48|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-13.48|-23.36|<0.0001
71870861|NCT03486457|143259047|SUPERIORITY||LS mean difference|-7.22|STANDARD_ERROR_OF_MEAN|2.453||0.0037|TWO_SIDED|95.0|-12.06|-2.38|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.38|-12.06|0.0037
71870862|NCT03486457|143259047|SUPERIORITY||LS mean difference|-7.66|STANDARD_ERROR_OF_MEAN|2.267||0.0009|TWO_SIDED|95.0|-12.13|-3.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-3.18|-12.13|0.0009
71870863|NCT03486457|143259048|SUPERIORITY||LS mean difference|-7.2|STANDARD_ERROR_OF_MEAN|1.108|<|0.0001|TWO_SIDED|95.0|-9.39|-5.02|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.02|-9.39|<0.0001
71870864|NCT03486457|143259048|SUPERIORITY||LS mean difference|-7.87|STANDARD_ERROR_OF_MEAN|1.171|<|0.0001|TWO_SIDED|95.0|-10.18|-5.56|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.56|-10.18|<0.0001
71870865|NCT03486457|143259048|SUPERIORITY||LS mean difference|-7.41|STANDARD_ERROR_OF_MEAN|1.182|<|0.0001|TWO_SIDED|95.0|-9.74|-5.08|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.08|-9.74|<0.0001
71870866|NCT03486457|143259048|SUPERIORITY||LS mean difference|-7.8|STANDARD_ERROR_OF_MEAN|1.221|<|0.0001|TWO_SIDED|95.0|-10.21|-5.39|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.39|-10.21|<0.0001
71870867|NCT03486457|143259048|SUPERIORITY||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.615||0.6264|TWO_SIDED|95.0|-0.91|1.51|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||1.51|-0.91|0.6264
71870868|NCT03486457|143259048|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.778||0.1008|TWO_SIDED|95.0|-2.82|0.25|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-2.82|0.1008
71870869|NCT03486457|143259049|SUPERIORITY||Difference in percentage of participants|0.44|STANDARD_ERROR_OF_MEAN|1.77||0.8032|TWO_SIDED|95.0|-3.02|3.9|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.90|-3.02|0.8032
71870870|NCT03486457|143259049|SUPERIORITY||Difference in percentage of participants|7.47|STANDARD_ERROR_OF_MEAN|3.44||0.0298|TWO_SIDED|95.0|0.73|14.21|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||14.21|0.73|0.0298
71870871|NCT03486457|143259049|SUPERIORITY||Difference in percentage of participants|-11.19|STANDARD_ERROR_OF_MEAN|6.48||0.084|TWO_SIDED|95.0|-23.88|1.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||1.50|-23.88|0.0840
71870872|NCT03486457|143259050|SUPERIORITY||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.111||0.002|TWO_SIDED|95.0|-0.57|-0.13|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.57|0.0020
71870873|NCT03486457|143259050|SUPERIORITY||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.32|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.32|-0.87|<0.0001
71870874|NCT03486457|143259050|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.156||0.9678|TWO_SIDED|95.0|-0.3|0.31|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.31|-0.30|0.9678
71870875|NCT03486457|143259051|SUPERIORITY||Difference in percentage of participants|14.96|STANDARD_ERROR_OF_MEAN|5.78||0.0097|TWO_SIDED|95.0|3.63|26.3|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||26.30|3.63|0.0097
71914314|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|33.5|||||TWO_SIDED|95.0|-66.8|133.9||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 5||133.9|-66.8|
71914315|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|99.8|||||TWO_SIDED|95.0|-2.4|202.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 5||202.0|-2.4|
71914316|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|37.8|||||TWO_SIDED|95.0|-107.1|182.6||||||LS Mean difference: Treatment A vs. Treatment B, E, G \& I (placebo) Day 10||182.6|-107.1|
71914317|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|-72.0|||||TWO_SIDED|95.0|-215.7|71.8||||||LS Mean difference: Treatment C vs. Treatment B, E, G \& I (placebo) Day 10||71.8|-215.7|
71914318|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|-72.3|||||TWO_SIDED|95.0|-241.5|96.9||||||LS Mean difference: Treatment D vs. Treatment B, E, G \& I (placebo) Day 10||96.9|-241.5|
71914319|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|-17.9|||||TWO_SIDED|95.0|-154.9|119.2||||||LS Mean difference: Treatment F vs. Treatment B, E, G \& I (placebo) Day 10||119.2|-154.9|
71914320|NCT01332097|143349916|SUPERIORITY||Least squares mean difference|123.6|||||TWO_SIDED|95.0|-15.8|263.0||||||LS Mean difference: Treatment H vs. Treatment B, E, G \& I (placebo) Day 10||263.0|-15.8|
71914321|NCT00431496|143349918|SUPERIORITY_OR_OTHER||Percentage of participants|42.3||||||95.0|30.8|53.7||||||||53.7|30.8|
71914322|NCT00431496|143349919|SUPERIORITY_OR_OTHER||Percentage of participants|52.1||||||95.0|40.5|63.7||||||||63.7|40.5|
71914323|NCT00431496|143349920|SUPERIORITY_OR_OTHER||Percentage of participants|78.9||||||95.0|69.4|88.4||||||||88.4|69.4|
71914324|NCT00431496|143349921|SUPERIORITY_OR_OTHER||Percentage of participants|54.9||||||95.0|43.4|66.5||||||||66.5|43.4|
71914325|NCT00431496|143349922|SUPERIORITY_OR_OTHER||Percentage of participants|53.5||||||95.0|41.9|65.1||||||||65.1|41.9|
71914326|NCT00431496|143349923|SUPERIORITY_OR_OTHER||Percentage of participants|46.5||||||95.0|34.9|58.1||||||||58.1|34.9|
71914327|NCT01248585|143349926|SUPERIORITY||Risk Difference (RD)|0.09|STANDARD_ERROR_OF_MEAN|0.053||0.05|TWO_SIDED|90.0|0.0|0.177||1-sided p-value.|Cochran-Mantel-Haenszel|||One-sided 0.05 level test with 90% power, 298 participants required.||0.177|0|0.05
71914328|NCT01248585|143349927|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.009||||0.432|TWO_SIDED|95.0|-0.08|0.1|||Cochran-Mantel-Haenszel|||||0.10|-0.08|0.432
71914329|NCT01248585|143349929|SUPERIORITY||Risk Difference (RD)|0.09||||0.15|TWO_SIDED|90.0|0.01|0.18||Fisher exact test.|Fisher Exact|||||0.18|0.01|0.15
71914330|NCT01248585|143349930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.07|TWO_SIDED|90.0|-5.06|3.97|||Wilcoxon (Mann-Whitney)|||||3.97|-5.06|0.07
71914331|NCT03180294|143349936|SUPERIORITY|||||||0.46|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.46
71914332|NCT03180294|143349936|SUPERIORITY|||||||0.54|||||||t-test, 1 sided|||Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..||||0.54
71914333|NCT03180294|143349937|SUPERIORITY|||||||0.95||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.95
71914334|NCT03180294|143349937|SUPERIORITY|||||||0.73||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.73
71914335|NCT03180294|143349937|SUPERIORITY|||||||0.46||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.46
71914336|NCT03180294|143349937|SUPERIORITY|||||||0.42||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.42
71914337|NCT03180294|143349938|SUPERIORITY|||||||0.24||||||One-side significance level 0.05|t-test, 1 sided|||||||0.24
71914338|NCT03180294|143349938|SUPERIORITY|||||||0.74||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.74
71914339|NCT03180294|143349939|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
71914340|NCT03180294|143349939|SUPERIORITY|||||||0.6||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.60
71914341|NCT03180294|143349939|SUPERIORITY|||||||0.9||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.90
71914342|NCT03180294|143349939|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
71914343|NCT03180294|143349940|SUPERIORITY|||||||0.41||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.41
71914344|NCT03180294|143349940|SUPERIORITY|||||||0.35||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.35
71914345|NCT03180294|143349940|SUPERIORITY|||||||0.83||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.83
71914346|NCT03180294|143349940|SUPERIORITY|||||||0.79||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.79
71914347|NCT03180294|143349941|SUPERIORITY|||||||0.78||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.78
71914348|NCT03180294|143349941|SUPERIORITY|||||||0.51||||||One-sided significance level 0.05|t-test, 1 sided|||Week 5||||0.51
71914349|NCT03180294|143349941|SUPERIORITY|||||||0.49||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.49
71914350|NCT03180294|143349941|SUPERIORITY|||||||0.5||||||One-sided significance level 0.05|t-test, 1 sided|||Week 9||||0.50
71914351|NCT03180294|143349942|SUPERIORITY|||||||0.71|||||||Chi-squared|One-sided significance level 0.05||||||0.71
71914352|NCT03180294|143349942|SUPERIORITY|||||||0.34|||||||Chi-squared|One-sided significance level 0.05||||||0.34
71914353|NCT03180294|143349943|SUPERIORITY|||||||0.23||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.23
71914354|NCT03180294|143349943|SUPERIORITY|||||||0.25||||||One-sided significance level 0.05|t-test, 1 sided|||||||0.25
71870876|NCT03486457|143259051|SUPERIORITY||Difference in percentage of participants|24.89|STANDARD_ERROR_OF_MEAN|8.2||0.0024|TWO_SIDED|95.0|8.81|40.97|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||40.97|8.81|0.0024
71870877|NCT03486457|143259051|SUPERIORITY||Difference in percentage of participants|-17.93|STANDARD_ERROR_OF_MEAN|11.03||0.1042|TWO_SIDED|95.0|-39.55|3.7|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||3.70|-39.55|0.1042
71870878|NCT03486457|143259052|SUPERIORITY||LS mean difference|-25.89|STANDARD_ERROR_OF_MEAN|7.858||0.0014|TWO_SIDED|95.0|-41.49|-10.29|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.29|-41.49|0.0014
71870879|NCT03486457|143259052|SUPERIORITY||LS mean difference|-34.91|STANDARD_ERROR_OF_MEAN|8.948||0.0002|TWO_SIDED|95.0|-52.69|-17.13|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-17.13|-52.69|0.0002
71870880|NCT03486457|143259052|SUPERIORITY||LS mean difference|5.31|STANDARD_ERROR_OF_MEAN|10.663||0.62|TWO_SIDED|95.0|-15.9|26.51|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||26.51|-15.90|0.6200
71870881|NCT03486457|143259053|SUPERIORITY||LS mean difference|-39.65|STANDARD_ERROR_OF_MEAN|10.862||0.0004|TWO_SIDED|95.0|-61.21|-18.08|||Mixed Models Analysis|||Month 1, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-18.08|-61.21|0.0004
71870882|NCT03486457|143259053|SUPERIORITY||LS mean difference|-25.18|STANDARD_ERROR_OF_MEAN|8.453||0.0037|TWO_SIDED|95.0|-41.97|-8.4|||Mixed Models Analysis|||Month 1, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-8.40|-41.97|0.0037
71870883|NCT03486457|143259053|SUPERIORITY||LS mean difference|-21.3|STANDARD_ERROR_OF_MEAN|10.423||0.0438|TWO_SIDED|95.0|-42.0|-0.61|||Mixed Models Analysis|||Month 1, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.61|-42.00|0.0438
71870884|NCT03486457|143259053|SUPERIORITY||LS mean difference|-49.11|STANDARD_ERROR_OF_MEAN|10.529|<|0.0001|TWO_SIDED|95.0|-70.03|-28.19|||Mixed Models Analysis|||Month 3, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-28.19|-70.03|<0.0001
71870885|NCT03486457|143259053|SUPERIORITY||LS mean difference|-29.71|STANDARD_ERROR_OF_MEAN|9.47||0.0023|TWO_SIDED|95.0|-48.52|-10.89|||Mixed Models Analysis|||Month 3, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-10.89|-48.52|0.0023
71870886|NCT03486457|143259053|SUPERIORITY||LS mean difference|-36.78|STANDARD_ERROR_OF_MEAN|10.72||0.0009|TWO_SIDED|95.0|-58.08|-15.49|||Mixed Models Analysis|||Month 3, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-15.49|-58.08|0.0009
71870887|NCT03486457|143259053|SUPERIORITY||LS mean difference|7.03|STANDARD_ERROR_OF_MEAN|10.495||0.5048|TWO_SIDED|95.0|-13.84|27.9|||Mixed Models Analysis|||Month 6, Erythema: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||27.90|-13.84|0.5048
71870888|NCT03486457|143259053|SUPERIORITY||LS mean difference|9.16|STANDARD_ERROR_OF_MEAN|12.273||0.4575|TWO_SIDED|95.0|-15.24|33.57|||Mixed Models Analysis|||Month 6, Induration: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||33.57|-15.24|0.4575
71870889|NCT03486457|143259053|SUPERIORITY||LS mean difference|0.69|STANDARD_ERROR_OF_MEAN|11.539||0.9523|TWO_SIDED|95.0|-22.26|23.65|||Mixed Models Analysis|||Month 6, Scaling: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||23.65|-22.26|0.9523
71870890|NCT03486457|143259054|SUPERIORITY||LS mean difference|-28.69|STANDARD_ERROR_OF_MEAN|8.386||0.0008|TWO_SIDED|95.0|-45.24|-12.15|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-12.15|-45.24|0.0008
71870891|NCT03486457|143259054|SUPERIORITY||LS mean difference|-46.47|STANDARD_ERROR_OF_MEAN|10.632|<|0.0001|TWO_SIDED|95.0|-67.45|-25.49|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-25.49|-67.45|<0.0001
71870892|NCT03486457|143259054|SUPERIORITY||LS mean difference|-26.76|STANDARD_ERROR_OF_MEAN|10.778||0.0141|TWO_SIDED|95.0|-48.05|-5.47|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-5.47|-48.05|0.0141
71870893|NCT03486457|143259055|SUPERIORITY||LS mean difference|-10.75|STANDARD_ERROR_OF_MEAN|2.399|<|0.0001|TWO_SIDED|95.0|-15.48|-6.02|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.02|-15.48|<0.0001
71870894|NCT03486457|143259055|SUPERIORITY||LS mean difference|-19.45|STANDARD_ERROR_OF_MEAN|2.575|<|0.0001|TWO_SIDED|95.0|-24.52|-14.37|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-14.37|-24.52|<0.0001
71870895|NCT03486457|143259055|SUPERIORITY||LS mean difference|-6.7|STANDARD_ERROR_OF_MEAN|2.289||0.0039|TWO_SIDED|95.0|-11.22|-2.18|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.18|-11.22|0.0039
71870896|NCT03486457|143259056|SUPERIORITY||Difference in percentage of participants|14.19|STANDARD_ERROR_OF_MEAN|5.89||0.016|TWO_SIDED|95.0|2.64|25.73|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.73|2.64|0.0160
71870897|NCT03486457|143259056|SUPERIORITY||Difference in percentage of participants|25.65|STANDARD_ERROR_OF_MEAN|8.06||0.0015|TWO_SIDED|95.0|9.86|41.44|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.44|9.86|0.0015
71870898|NCT03486457|143259056|SUPERIORITY||Difference in percentage of participants|23.05|STANDARD_ERROR_OF_MEAN|9.16||0.0118|TWO_SIDED|95.0|5.11|41.0|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||41.00|5.11|0.0118
71870899|NCT03486457|143259057|SUPERIORITY||LS mean difference|-3.09|STANDARD_ERROR_OF_MEAN|1.259||0.0156|TWO_SIDED|95.0|-5.58|-0.6|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.60|-5.58|0.0156
71870900|NCT03486457|143259057|SUPERIORITY||LS mean difference|-4.06|STANDARD_ERROR_OF_MEAN|0.989|<|0.0001|TWO_SIDED|95.0|-6.02|-2.1|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-2.10|-6.02|<0.0001
71870901|NCT03486457|143259057|SUPERIORITY||LS mean difference|-0.97|STANDARD_ERROR_OF_MEAN|0.346||0.0061|TWO_SIDED|95.0|-1.65|-0.28|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.28|-1.65|0.0061
71870902|NCT03486457|143259058|SUPERIORITY||Difference in percentage of participants|13.03|STANDARD_ERROR_OF_MEAN|10.01||0.193|TWO_SIDED|95.0|-6.59|32.64|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.64|-6.59|0.1930
71914355|NCT02527564|143350010|OTHER|||||||0.1||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.10
71914356|NCT02527564|143350010|OTHER|||||||0.57||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Within group change at week 1- placebo (double-blind) group||||0.57
71870903|NCT03486457|143259058|SUPERIORITY||Difference in percentage of participants|24.3|STANDARD_ERROR_OF_MEAN|10.11||0.0162|TWO_SIDED|95.0|4.48|44.11|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||44.11|4.48|0.0162
71870904|NCT03486457|143259058|SUPERIORITY||Difference in percentage of participants|4.07|STANDARD_ERROR_OF_MEAN|10.83||0.7068|TWO_SIDED|95.0|-17.15|25.3|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||25.30|-17.15|0.7068
71870905|NCT03486457|143259059|SUPERIORITY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.271||0.2811|TWO_SIDED|95.0|-0.83|0.25|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.25|-0.83|0.2811
71870906|NCT03486457|143259059|SUPERIORITY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.295||0.214|TWO_SIDED|95.0|-0.96|0.22|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.96|0.2140
71914357|NCT02527564|143350010|OTHER|||||||0.44||||||A p-value of \<0.05 would be considered statistically significant.|Unpaired 2-sided t-test|||Between group change at week 1||||0.44
71914358|NCT02527564|143350011|OTHER|||||||0.035||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at week 1 - suvorexant (double-blind)||||0.035
71914359|NCT02527564|143350011|OTHER|||||||0.55|||||||Paired 2-sided t-test|A p-value of \<0.05 would be considered statistically significant.||Within group change at week 1- placebo (double-blind) group||||0.55
71914360|NCT02527564|143350011|OTHER|||||||0.89||||||A p-value of \<0.05 would be considered statistically significant.|Paired 2-sided t-test|||Between group change at week 1||||0.89
71914361|NCT02527564|143350012|OTHER|||||||0.97||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.97
71914362|NCT02527564|143350013|OTHER|||||||0.28||||||A p-value of \<0.05 would be considered significantly significant.|Paired 2-sided t-test|||Within group change at month 3 - suvorexant (open-label)||||0.28
71914363|NCT00420342|143350014|SUPERIORITY_OR_OTHER|||||||0.1182||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1182
71914364|NCT00420342|143350014|SUPERIORITY_OR_OTHER|||||||0.2224||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.2224
71914365|NCT00420342|143350014|SUPERIORITY_OR_OTHER|||||||0.6929||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.6929
71914366|NCT00420342|143350015|SUPERIORITY_OR_OTHER|||||||0.0702||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.0702
71914367|NCT00420342|143350015|SUPERIORITY_OR_OTHER|||||||0.198||95.0||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.1980
71914368|NCT00420342|143350015|SUPERIORITY_OR_OTHER|||||||0.5777||95.0||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.||||0.5777
71914369|NCT02473289|143350033|SUPERIORITY||Difference of Least Square (LS) Means|-0.8|STANDARD_ERROR_OF_MEAN|1.67||0.31|TWO_SIDED|75.0|-2.77|1.1||1-sided|MMRM|Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.||||1.10|-2.77|0.310
71870907|NCT03486457|143259059|SUPERIORITY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.239||0.2817|TWO_SIDED|95.0|-0.74|0.22|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.22|-0.74|0.2817
71914370|NCT03285490|143350055|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 complete clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
71914371|NCT03285490|143350056|SUPERIORITY||||||<|0.0001||||||P-value threshold for statistical significance was 0.5%.|Cochran-Mantel-Haenszel|||Statistical significance in the study for Day 57 partial clearance rate was analyzed using a Cochran-Mantel-Haenszel model controlling for treatment location (face or scalp) and treatment group (Placebo versus KX2-391 Ointment 1%).||||<0.0001
71914372|NCT01291511|143350076|SUPERIORITY||Cox Proportional Hazard|5.2|||<|0.0001|TWO_SIDED|95.0|3.2|8.4|||Log Rank|||||8.4|3.2|<0.0001
71914373|NCT01291511|143350077|SUPERIORITY||||||<|0.0001||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||<0.0001
71914374|NCT01291511|143350079|SUPERIORITY|||||||0.0062||||||P-value is based on an ANCOVA model with treatment and site as main effects and DBRP baseline as a covariate.|ANCOVA|||||||0.0062
71914375|NCT00047008|143350084|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.18|TWO_SIDED|95.0|0.719|1.128|||Log Rank|||A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.||1.128|0.719|0.180
71914376|NCT00047008|143350085|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.76|TWO_SIDED|95.0|0.83|1.43||One-sided significance level = 0.05|Gray's test|||||1.43|0.83|0.76
71914377|NCT00047008|143350086|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.8|TWO_SIDED|95.0|0.85|1.44||One-sided significance level = 0.05|Gray's test|||||1.44|0.85|0.80
71914378|NCT00047008|143350087|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.42|TWO_SIDED|95.0|0.81|1.2||One-sided significance level = 0.05|Log Rank|||||1.20|0.81|0.42
71914379|NCT00047008|143350088|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.81|1.23||One-sided significance level = 0.05|Log Rank|||||1.23|0.81|0.50
71914380|NCT00047008|143350089|SUPERIORITY|||||||0.21||||||Two-side significance level = 0.05|Fisher Exact|||Acute toxicity||||0.21
71914381|NCT00047008|143350089|SUPERIORITY|||||||0.18||||||Two-sided significance level = 0.05|Fisher Exact|||Late toxicity||||0.18
71914382|NCT00047008|143350090|SUPERIORITY|||||||0.92||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.92
71914383|NCT00047008|143350091|SUPERIORITY|||||||0.67||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.67
71914384|NCT00047008|143350092|SUPERIORITY|||||||0.43||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.43
71914385|NCT00047008|143350093|SUPERIORITY|||||||0.39||||||Two-sided significance level = 0.05|t-test, 2 sided|||Two hundred and fifty-two patients (126/arm) provide at least 86% power to detect a difference of 7 (standard deviation 18) between arms with a two-sided significance level of 0.05.||||0.39
71914386|NCT01047436|143350104|SUPERIORITY_OR_OTHER||difference between treatments|26.7||||0.17|TWO_SIDED|95.0|-0.3|53.7|||Fisher Exact|||The sample size was not statistically determined in this initial trial with ArTimist. For the primary outcome analysis, the percentage of patients defined as having success were determined. The difference between ArTiMist and quinine, along with its 95% confidence interval (CI) were determined. The difference between treatments were compared using Fisher's Exact test||53.7|-0.3|0.17
71914387|NCT01047436|143350106|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.7|TWO_SIDED|95.0|0.48|3.01|||Log Rank|||The time for the parasite count to fall by 90% (PCT90) was determined for each patient as the time in minutes/seconds, when the parasite count fell by 90% The PCT90 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||3.01|0.48|0.70
71914388|NCT01047436|143350108|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.76||95.0|0.34|2.18||Difference between survival curves compared by Log Rank test|Log Rank|||The PCT50 was determined for each patient as the time in minutes/seconds, when the parasite count fell by 50% The PCT50 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.||2.18|0.34|0.76
71914389|NCT00424099|143350129|OTHER|||||||0.16|||||||Kruskal-Wallis|||||||0.16
71914390|NCT00424099|143350130|OTHER|||||||0.45|||||||Kruskal-Wallis|||||||0.45
71914391|NCT03377452|143350132|SUPERIORITY||Mean Difference (Final Values)|7.26|STANDARD_ERROR_OF_MEAN|6.02||0.2313|TWO_SIDED|95.0|-4.71|19.22|||t-test, 2 sided|||||19.22|-4.71|0.2313
71914392|NCT03377452|143350133|SUPERIORITY||Mean Difference (Net)|-3.31|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-4.91|-1.72|||Mixed Models Analysis||The parameter estimate is the change in the outcome from baseline to 3-months after the last intervention/control session for the intervention group versus the same change in the control group.|||-1.72|-4.91|<0.001
71914393|NCT00796003|143350146|SUPERIORITY_OR_OTHER||Overall Response Rate|26.5|STANDARD_ERROR_OF_MEAN|7.6|<|0.0001|TWO_SIDED|90.0|14.6|41.6|||Binomial test|one-tailed 5% level at a significance level||Null Hypothesis: Overall Remission Rate = 5%||41.6|14.6|<0.0001
71914394|NCT05179057|143350157|SUPERIORITY|A logistic regression model included treatment, level of viremia at baseline (≥10,000 copies/mL or \<10,000 copies/mL adenovirus DNA), age (≥12 years or \<12 years), and absolute lymphocyte counts at baseline. The null hypothesis is that the true percentage for posoleucel plus SoC is less than or equal to the true percentage for placebo plus SoC, and the alternative hypothesis is that it is greater.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.26|3.69|||||Posoleucel versus Placebo|||3.69|0.26|
71914395|NCT02437162|143350164|SUPERIORITY||Percentage difference|2.586||||0.669|TWO_SIDED|95.0|-9.138|14.31|||Cochran-Mantel-Haenszel|||||14.310|-9.138|0.669
71870908|NCT03486457|143259060|SUPERIORITY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.182||0.9407|TWO_SIDED|95.0|-0.37|0.35|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.37|0.9407
71870909|NCT03486457|143259060|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.293||0.4295|TWO_SIDED|95.0|-0.81|0.35|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.35|-0.81|0.4295
71870910|NCT03486457|143259060|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.314||0.2946|TWO_SIDED|95.0|-0.95|0.29|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.29|-0.95|0.2946
71870911|NCT03486457|143259061|SUPERIORITY||Difference in percentage of participants|21.32|STANDARD_ERROR_OF_MEAN|5.62||0.0001|TWO_SIDED|95.0|10.32|32.33|||Normal approximation|||Week 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.33|10.32|0.0001
71870912|NCT03486457|143259061|SUPERIORITY||Difference in percentage of participants|36.03|STANDARD_ERROR_OF_MEAN|6.49|<|0.0001|TWO_SIDED|95.0|23.31|48.75|||Normal approximation|||Month 1: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||48.75|23.31|<0.0001
71914396|NCT02437162|143350164|SUPERIORITY||Percentage difference|-0.646||||0.913|TWO_SIDED|95.0|-12.18|10.887|||Cochran-Mantel-Haenszel|||||10.887|-12.180|0.913
71914397|NCT04338321|143350200|SUPERIORITY||Mean Difference (Final Values)|9.44|||=|0.003|TWO_SIDED|95.0|3.19|15.68|||Cochran-Mantel-Haenszel|||||15.68|3.19|=0.003
71914398|NCT03107793|143350225|SUPERIORITY||||||=|0.0871|||||||Cochran-Mantel-Haenszel|||||||= 0.0871
71914399|NCT02808507|143350249|OTHER||Treatment initiation ratio|1.04||||0.73|TWO_SIDED|95.0|0.8|1.3|||See above comments|||The primary analysis was based on the facility-level rate ratio. We first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% CI. We first fit a Poisson regression to the facility-level counts and the district and historical volume covariates. The residuals ratios, calculated as the ratio of the observed over the expected counts, were then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.||1.3|0.80|0.73
71914400|NCT02808507|143350250|OTHER||Treatment initiation ratio|1.05||||0.68|TWO_SIDED|95.0|0.97|1.13|||Poisson regression||Adjusted for district, study phase and clinic random effect.|The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics during the two study periods, excluding the six-month washout period. The number of people starting treatment for incident TB was calculated by performing a review of paper and electronic medical records at each clinic on a quarterly basis during the study.||1.13|0.97|0.68
71914401|NCT02808507|143350251|OTHER||Prevalence ratio|1.0||||0.8|TWO_SIDED|95.0|0.51|1.95||"The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts (secondary cases) by arm."|Poisson regression||Adjusted for study phase and district|||1.95|0.51|0.80
71914402|NCT01989572|143350256|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|||||||Log Rank|stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.||||||0.528
71914403|NCT01989572|143350257|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|||||||Log Rank|stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions||||||0.131
71914404|NCT01989572|143350258|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Log Rank|stratifying on GM-CSF, site of metastases and number of metastatic lesions||||||0.60
71914405|NCT01989572|143350259|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71||||||stratifying on GM-CSF, site of metastases and number of metastatic lesions|Log Rank|||||||0.71
71914406|NCT01989572|143350260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.88
71914407|NCT01989572|143350260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with negative HLA-A2 status||||0.69
71914408|NCT01989572|143350261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status||||0.91
71914409|NCT01989572|143350261|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparisons in patients with negative HLA-A2 status||||0.13
71914410|NCT02910089|143350262|SUPERIORITY|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Mean Difference (Final Values)|0.06|||||TWO_SIDED|95.0|-0.2|0.32||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function (as a continuous variable) and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|||0.32|-0.2|
71914411|NCT02910089|143350263|OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-2.42|4.4||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with an identity link function and normally distributed errors|Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|Average of the percentage (proportion x 100) of days covered across all subjects.||4.40|-2.42|
71914412|NCT02910089|143350264|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.83|1.28||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|GEE|Generalized Estimating Equations with a logit link and binary distributed errors||||1.28|0.83|
71914413|NCT02910089|143350265|OTHER|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.71|1.17||As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|See comments|Generalized Estimating Equations with a logit link and binary distributed errors||||1.17|0.71|
71914414|NCT02280096|143350266|SUPERIORITY||t-boostrap|0.028||||0.028|TWO_SIDED||||||t-test, 1 sided|||||||0.028
71914415|NCT02280096|143350267|SUPERIORITY||t-boostrap|0.001||||0.001|ONE_SIDED||||||t-test, 1 sided|||||||0.001
71914416|NCT02280096|143350268|SUPERIORITY||t-boostrap|0.016||||0.016|TWO_SIDED||||||t-test, 1 sided|||||||0.016
71914417|NCT02280096|143350269|SUPERIORITY||t-boostrap|0.64||||0.64|ONE_SIDED||||||t-test, 1 sided|||Reading speed||||0.64
71914418|NCT02280096|143350269|SUPERIORITY||t-boostrap|0.43||||0.43|TWO_SIDED||||||t-test, 1 sided|||Count speed||||0.43
71914419|NCT02280096|143350269|SUPERIORITY||t-boostrap|0.9||||0.9|TWO_SIDED||||||t-test, 1 sided|||Alternation||||0.9
71914420|NCT02280096|143350270|SUPERIORITY||t-boostrap|0.83||||0.83|TWO_SIDED||||||t-test, 1 sided|||||||0.83
71914421|NCT02280096|143350271|SUPERIORITY||t-boostrap|0.92||||0.92|ONE_SIDED||||||t-test, 1 sided|||||||0.92
71914422|NCT02280096|143350272|SUPERIORITY||t-boostrap|0.017||||0.017|TWO_SIDED||||||t-test, 1 sided|||Total moves||||0.017
71914423|NCT02280096|143350272|SUPERIORITY||t-boostrap|0.01||||0.01|TWO_SIDED||||||t-test, 1 sided|||Correct moves||||0.010
71914424|NCT02280096|143350273|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Execution time||||0.001
71914425|NCT02280096|143350273|SUPERIORITY||t-boostrap|0.001||||0.001|TWO_SIDED||||||t-test, 1 sided|||Problem-solving time||||0.001
71914426|NCT01872897|143350325|SUPERIORITY||Mean Difference (Final Values)|-9.79||||0.0003|TWO_SIDED|95.0|-14.85|-4.74|||Mixed Models Analysis|||||-4.74|-14.85|0.0003
71914427|NCT01872897|143350326|SUPERIORITY||Mean Difference (Final Values)|-15.76|||<|0.0001|TWO_SIDED|95.0|-22.82|-8.71|||Mixed Models Analysis|||||-8.71|-22.82|<0.0001
71914428|NCT01872897|143350327|SUPERIORITY||Median Difference (Final Values)|-19.4||||0.0004|TWO_SIDED|95.0|-29.6|-9.2|||Mixed Models Analysis|||||-9.2|-29.6|0.0004
71914429|NCT01872897|143350328|SUPERIORITY||Mean Difference (Final Values)|-16.3||||0.0019|TWO_SIDED|95.0|-26.2|-6.4|||Mixed Models Analysis|||||-6.4|-26.2|0.0019
71914430|NCT01872897|143350329|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.029|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||||-0.1|-1.6|0.0290
71914431|NCT01872897|143350330|SUPERIORITY||Mean Difference (Final Values)|-14.4|||<|0.0001|TWO_SIDED|95.0|-20.57|-8.23|||Mixed Models Analysis|||||-8.23|-20.57|<0.0001
71914432|NCT01872897|143350331|SUPERIORITY||Mean Difference (Final Values)|-23.37|||<|0.0001|TWO_SIDED|95.0|-31.55|-15.19|||Mixed Models Analysis|||||-15.19|-31.55|<0.0001
71914433|NCT01872897|143350332|SUPERIORITY||Mean Difference (Final Values)|-7.3|||<|0.0001|TWO_SIDED|95.0|-10.0|-4.6|||Mixed Models Analysis|||||-4.6|-10.0|<0.0001
71914434|NCT01872897|143350333|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.0001|TWO_SIDED|95.0|-9.4|-3.3|||Mixed Models Analysis|||||-3.3|-9.4|0.0001
71914435|NCT01872897|143350334|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0075|TWO_SIDED|95.0|-10.9|-1.8|||Mixed Models Analysis|||||-1.8|-10.9|0.0075
71914436|NCT01872897|143350335|SUPERIORITY||Mean Difference (Final Values)|-24.145||||0.0007|TWO_SIDED|95.0|-37.432|-10.858|||Mixed Models Analysis|||||-10.858|-37.432|0.0007
71914437|NCT02418585|143350336|SUPERIORITY||Difference of Least Square (LS) Means|-4.0|STANDARD_ERROR_OF_MEAN|1.69|=|0.02|TWO_SIDED|95.0|-7.31|-0.64|||Mixed Model for Repeated Measures|||||-0.64|-7.31|=0.020
71914438|NCT02418585|143350337|SUPERIORITY||Difference of Least Square (LS) Means|-3.5|||=|0.034|TWO_SIDED|95.0|-6.67|-0.26|||ANCOVA|||||-0.26|-6.67|=0.034
71914439|NCT02040857|143350352|OTHER|Exact binomial test||||||0.0011|||||||Exact binomial test|||Primary objective is treatment discontinuation rate at 2 yr for patients receiving Palbociclib therapy. If the true rate of discontinuation by two years is 48% or higher, treatment duration will be considered not feasible and not worthy of further study. If the rate of discontinuation is 33.3% or less, the 2 yr duration will be deemed feasible and worthy of further study. Using a one-sided alpha = 0.025, there is \> 90% power to reject the null hypothesis in favor of feasibility.||||0.0011
71914440|NCT04159701|143350358|SUPERIORITY||Mean Difference (Final Values)|2.94||||0.38|TWO_SIDED|95.0|-3.73|9.6|||Mixed Models Analysis|||||9.60|-3.73|0.380
71914441|NCT04159701|143350359|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.415|TWO_SIDED|95.0|-1.89|4.5|||Mixed Models Analysis|||||4.50|-1.89|0.415
71914442|NCT04159701|143350360|SUPERIORITY||Mean Difference (Final Values)|1.72||||0.369|TWO_SIDED|95.0|-2.09|5.53|||Mixed Models Analysis|||||5.53|-2.09|0.369
71914443|NCT04159701|143350361|SUPERIORITY||Odds Ratio (OR)|0.61||||0.674|TWO_SIDED|95.0|0.14|2.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< 28 vs \>= 28) score.||||2.70|0.14|0.674
71914444|NCT04159701|143350362|SUPERIORITY||Odds Ratio (OR)|0.59||||0.674|TWO_SIDED|95.0|0.13|2.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted by baseline UAS7 (\< median vs \>= median) score.||||2.68|0.13|0.674
71914445|NCT03605836|143350365|SUPERIORITY||Least Squares (LS) Mean Difference|-4.01|||=|0.0021|TWO_SIDED|95.0|-6.55|-1.46|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.46|-6.55|=0.0021
71914446|NCT03605836|143350365|SUPERIORITY||LS Mean Difference|-4.42|||=|0.0009|TWO_SIDED|95.0|-7.02|-1.82|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-1.82|-7.02|=0.0009
71914447|NCT03605836|143350366|SUPERIORITY||LS Mean Difference|-0.33|||=|0.0073|TWO_SIDED|95.0|-0.57|-0.09|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.09|-0.57|=0.0073
71914448|NCT03605836|143350366|SUPERIORITY||LS Mean Difference|-0.28|||=|0.0245|TWO_SIDED|95.0|-0.53|-0.04|||MMRM||The comparison between the centanafadine and the placebo group was tested at a significance level of 0.05.|||-0.04|-0.53|=0.0245
71914449|NCT02845440|143350376|SUPERIORITY||Odds Ratio (OR)|2.4||||0.013|TWO_SIDED|95.0|1.2|4.79||A priori threshold for significance was p \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.79|1.20|0.013
71914450|NCT02845440|143350376|SUPERIORITY||Odds Ratio (OR)|1.31||||0.481|TWO_SIDED|95.0|0.62|2.74||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.74|0.62|0.481
71870913|NCT03486457|143259061|SUPERIORITY||Difference in percentage of participants|52.21|STANDARD_ERROR_OF_MEAN|5.79|<|0.0001|TWO_SIDED|95.0|40.86|63.55|||Normal approximation|||Month 2: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||63.55|40.86|<0.0001
71870914|NCT03486457|143259061|SUPERIORITY||Difference in percentage of participants|39.71|STANDARD_ERROR_OF_MEAN|6.8|<|0.0001|TWO_SIDED|95.0|26.38|53.03|||Normal approximation|||Month 3: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||53.03|26.38|<0.0001
71683186|NCT05079230|142884463|SUPERIORITY||Stratified Odds Ratio|0.826||||0.3616|TWO_SIDED|95.0|0.545|1.251|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.251|0.545|0.3616
71870915|NCT03486457|143259061|SUPERIORITY||Difference in percentage of participants|18.38|STANDARD_ERROR_OF_MEAN|7.23||0.011|TWO_SIDED|95.0|4.22|32.55|||Normal approximation|||Month 4: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||32.55|4.22|0.0110
71870916|NCT03486457|143259061|SUPERIORITY||Difference in percentage of participants|16.18|STANDARD_ERROR_OF_MEAN|6.8||0.0173|TWO_SIDED|95.0|2.85|29.5|||Normal approximation|||Month 6: The normal approximation to the difference in binomial proportions was used to test the difference between the two treatment arms and to generate 95% CI and p-value for the difference in response rates.||29.50|2.85|0.0173
71914451|NCT02845440|143350376|SUPERIORITY||Odds Ratio (OR)|1.84||||0.036|TWO_SIDED|95.0|1.04|3.24||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||3.24|1.04|0.036
71914452|NCT02845440|143350377|SUPERIORITY||Odds Ratio (OR)|1.35||||0.174|TWO_SIDED|95.0|0.88|2.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||2.06|0.88|0.174
71914453|NCT02845440|143350377|SUPERIORITY||Odds Ratio (OR)|0.69||||0.092|TWO_SIDED|95.0|0.45|1.06||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.06|0.45|0.092
71914454|NCT02845440|143350378|SUPERIORITY||Odds Ratio (OR)|2.77|||<|0.001|TWO_SIDED|95.0|1.61|4.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||4.75|1.61|<0.001
71914455|NCT02845440|143350378|SUPERIORITY||Odds Ratio (OR)|0.9||||0.742|TWO_SIDED|95.0|0.5|1.64||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept.||1.64|0.50|0.742
71914456|NCT02845440|143350379|SUPERIORITY||Odds Ratio (OR)|1.57||||0.056|TWO_SIDED|95.0|0.99|2.51||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the AD+CHW intervention was 2.8%.|2.51|0.99|0.056
71914457|NCT02845440|143350380|SUPERIORITY||Odds Ratio (OR)|1.97||||0.012|TWO_SIDED|95.0|1.16|3.33||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for TAU, AD, and AD+CHW (cohort 1) as well as varenicline use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the AD+CHW intervention was 13.9%.|3.33|1.16|0.012
71914458|NCT02845440|143350381|SUPERIORITY||Odds Ratio (OR)|1.71||||0.032|TWO_SIDED|95.0|1.05|2.79||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.79|1.05|0.032
71914459|NCT02845440|143350381|SUPERIORITY||Odds Ratio (OR)|1.37||||0.376|TWO_SIDED|95.0|0.68|2.75||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||2.75|0.68|0.376
71914460|NCT02845440|143350381|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.3||||0.645|TWO_SIDED|95.0|0.42|4.05|||Regression, Logistic|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||4.05|0.42|0.645
71683187|NCT05079230|142884464|SUPERIORITY||Stratified Odds Ratio|0.856||||0.4679|TWO_SIDED|95.0|0.56|1.307|||Stratum-adjusted Mantel-Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.307|0.560|0.4679
71870917|NCT03486457|143259062|SUPERIORITY||LS mean difference|-0.63|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.79|-0.47|||Mixed Models Analysis|||Week 2: Analysis performed using mixed model for repeated measures (MMRM) which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.47|-0.79|<0.0001
71683188|NCT05079230|142884465|SUPERIORITY||Stratified Hazard Ratio|0.946||||0.7903|TWO_SIDED|95.0|0.73|1.225|||Stratified Log Rank||The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|||1.225|0.730|0.7903
71870918|NCT03486457|143259062|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.99|-0.62|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.62|-0.99|<0.0001
71870919|NCT03486457|143259062|SUPERIORITY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.105|<|0.0001|TWO_SIDED|95.0|-1.08|-0.66|||Mixed Models Analysis|||Month 2: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.66|-1.08|<0.0001
71870920|NCT03486457|143259062|SUPERIORITY||LS mean difference|-1.04|STANDARD_ERROR_OF_MEAN|0.122|<|0.0001|TWO_SIDED|95.0|-1.28|-0.8|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.80|-1.28|<0.0001
71870921|NCT03486457|143259062|SUPERIORITY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.129||0.0009|TWO_SIDED|95.0|-0.69|-0.18|||Mixed Models Analysis|||Month 4: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.18|-0.69|0.0009
71870922|NCT03486457|143259062|SUPERIORITY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.145||0.1202|TWO_SIDED|95.0|-0.51|0.06|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.06|-0.51|0.1202
71870923|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.72|STANDARD_ERROR_OF_MEAN|0.998||0.0003|TWO_SIDED|95.0|1.76|5.69|||Mixed Models Analysis|||Month 1, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.69|1.76|0.0003
71870924|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|1.102||0.0043|TWO_SIDED|95.0|1.01|5.35|||Mixed Models Analysis|||Month 1, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.35|1.01|0.0043
71870925|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.12|STANDARD_ERROR_OF_MEAN|0.861||0.0004|TWO_SIDED|95.0|1.42|4.82|||Mixed Models Analysis|||Month 1, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.82|1.42|0.0004
71870926|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.54|STANDARD_ERROR_OF_MEAN|0.938||0.0002|TWO_SIDED|95.0|1.69|5.39|||Mixed Models Analysis|||Month 1, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.39|1.69|0.0002
71870927|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.04|STANDARD_ERROR_OF_MEAN|1.203||0.0123|TWO_SIDED|95.0|0.67|5.41|||Mixed Models Analysis|||Month 1, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.41|0.67|0.0123
71870928|NCT03486457|143259063|SUPERIORITY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|1.115||0.0216|TWO_SIDED|95.0|0.38|4.78|||Mixed Models Analysis|||Month 1, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.78|0.38|0.0216
71683189|NCT05079230|142884468|SUPERIORITY||Stratified Odds Ratio|1.189||||0.4873|TWO_SIDED|95.0|0.727|1.945|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.945|0.727|0.4873
71870929|NCT03486457|143259063|SUPERIORITY||LS mean difference|2.04|STANDARD_ERROR_OF_MEAN|1.336||0.129|TWO_SIDED|95.0|-0.6|4.67|||Mixed Models Analysis|||Month 1, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.67|-0.60|0.1290
71870930|NCT03486457|143259063|SUPERIORITY||LS mean difference|1.91|STANDARD_ERROR_OF_MEAN|1.172||0.1043|TWO_SIDED|95.0|-0.4|4.22|||Mixed Models Analysis|||Month 1, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.22|-0.40|0.1043
71870931|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.77|STANDARD_ERROR_OF_MEAN|0.763|<|0.0001|TWO_SIDED|95.0|2.26|5.27|||Mixed Models Analysis|||Month 1, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.27|2.26|<0.0001
71870932|NCT03486457|143259063|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.178||0.1318|TWO_SIDED|95.0|-0.54|4.1|||Mixed Models Analysis|||Month 1, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.10|-0.54|0.1318
71870933|NCT03486457|143259063|SUPERIORITY||LS mean difference|2.53|STANDARD_ERROR_OF_MEAN|1.225||0.0402|TWO_SIDED|95.0|0.11|4.95|||Mixed Models Analysis|||Month 3, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.95|0.11|0.0402
71870934|NCT03486457|143259063|SUPERIORITY||LS mean difference|4.41|STANDARD_ERROR_OF_MEAN|1.227||0.0004|TWO_SIDED|95.0|1.99|6.83|||Mixed Models Analysis|||Month 3, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.83|1.99|0.0004
71870935|NCT03486457|143259063|SUPERIORITY||LS mean difference|5.29|STANDARD_ERROR_OF_MEAN|1.069|<|0.0001|TWO_SIDED|95.0|3.18|7.4|||Mixed Models Analysis|||Month 3, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.40|3.18|<0.0001
71870936|NCT03486457|143259063|SUPERIORITY||LS mean difference|5.28|STANDARD_ERROR_OF_MEAN|1.261|<|0.0001|TWO_SIDED|95.0|2.79|7.76|||Mixed Models Analysis|||Month 3, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.76|2.79|<0.0001
71683190|NCT05079230|142884469|SUPERIORITY||Stratified Odds Ratio|1.154||||0.5842|TWO_SIDED|95.0|0.69|1.932|||Stratum-adjusted Mantel Haenszel||Stratified odds ratio and 2-sided 95% CI were calculated from stratum-adjusted Mantel-Haenszel estimates adjusted for stratification factors.|||1.932|0.690|0.5842
71870937|NCT03486457|143259063|SUPERIORITY||LS mean difference|2.1|STANDARD_ERROR_OF_MEAN|1.366||0.1254|TWO_SIDED|95.0|-0.59|4.8|||Mixed Models Analysis|||Month 3, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.80|-0.59|0.1254
71870938|NCT03486457|143259063|SUPERIORITY||LS mean difference|4.34|STANDARD_ERROR_OF_MEAN|1.186||0.0003|TWO_SIDED|95.0|2.0|6.68|||Mixed Models Analysis|||Month 3, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.68|2.00|0.0003
71914461|NCT02845440|143350382|SUPERIORITY||Odds Ratio (OR)|1.85|||<|0.001|TWO_SIDED|95.0|1.34|2.56||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|The CHW intervention increased odds of self-reported use of any TUD medication by 1.85.||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||2.56|1.34|<0.001
71870939|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.43|STANDARD_ERROR_OF_MEAN|1.384||0.014|TWO_SIDED|95.0|0.7|6.16|||Mixed Models Analysis|||Month 3, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.16|0.70|0.0140
71870940|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.47|STANDARD_ERROR_OF_MEAN|1.268||0.0067|TWO_SIDED|95.0|0.97|5.98|||Mixed Models Analysis|||Month 3, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.98|0.97|0.0067
71870941|NCT03486457|143259063|SUPERIORITY||LS mean difference|4.17|STANDARD_ERROR_OF_MEAN|0.986|<|0.0001|TWO_SIDED|95.0|2.23|6.12|||Mixed Models Analysis|||Month 3, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||6.12|2.23|<0.0001
71870942|NCT03486457|143259063|SUPERIORITY||LS mean difference|3.27|STANDARD_ERROR_OF_MEAN|1.248||0.0094|TWO_SIDED|95.0|0.81|5.73|||Mixed Models Analysis|||Month 3, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.73|0.81|0.0094
71870943|NCT03486457|143259063|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.049||0.7098|TWO_SIDED|95.0|-1.68|2.46|||Mixed Models Analysis|||Month 6, Physical Functioning Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.46|-1.68|0.7098
71870944|NCT03486457|143259063|SUPERIORITY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.234||0.4019|TWO_SIDED|95.0|-1.4|3.47|||Mixed Models Analysis|||Month 6, Role - Physical Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.47|-1.40|0.4019
71870945|NCT03486457|143259063|SUPERIORITY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.186||0.7537|TWO_SIDED|95.0|-1.97|2.71|||Mixed Models Analysis|||Month 6, Bodily Pain Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.71|-1.97|0.7537
71870946|NCT03486457|143259063|SUPERIORITY||LS mean difference|1.22|STANDARD_ERROR_OF_MEAN|1.33||0.3595|TWO_SIDED|95.0|-1.4|3.85|||Mixed Models Analysis|||Month 6, General Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.85|-1.40|0.3595
71870947|NCT03486457|143259063|SUPERIORITY||LS mean difference|1.99|STANDARD_ERROR_OF_MEAN|1.52||0.1919|TWO_SIDED|95.0|-1.01|4.99|||Mixed Models Analysis|||Month 6, Vitality Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.99|-1.01|0.1919
71870948|NCT03486457|143259063|SUPERIORITY||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|1.209||0.8163|TWO_SIDED|95.0|-2.1|2.67|||Mixed Models Analysis|||Month 6, Social Function Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.67|-2.10|0.8163
71870949|NCT03486457|143259063|SUPERIORITY||LS mean difference|2.23|STANDARD_ERROR_OF_MEAN|1.368||0.1048|TWO_SIDED|95.0|-0.47|4.93|||Mixed Models Analysis|||Month 6, Role - Emotional Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.93|-0.47|0.1048
71870950|NCT03486457|143259063|SUPERIORITY||LS mean difference|0.71|STANDARD_ERROR_OF_MEAN|1.392||0.6118|TWO_SIDED|95.0|-2.04|3.45|||Mixed Models Analysis|||Month 6, Mental Health Domain: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.45|-2.04|0.6118
71870951|NCT03486457|143259063|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|1.014||0.6996|TWO_SIDED|95.0|-1.61|2.39|||Mixed Models Analysis|||Month 6, Physical Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.39|-1.61|0.6996
71870952|NCT03486457|143259063|SUPERIORITY||LS mean difference|1.78|STANDARD_ERROR_OF_MEAN|1.424||0.2122|TWO_SIDED|95.0|-1.03|4.59|||Mixed Models Analysis|||Month 6, Mental Component Summary: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.59|-1.03|0.2122
71914462|NCT02845440|143350382|SUPERIORITY||Odds Ratio (OR)|0.7||||0.084|TWO_SIDED|95.0|0.46|1.05|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.05|0.46|0.084
71914463|NCT02845440|143350382|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.22||||0.589|TWO_SIDED|95.0|0.59|2.55|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.55|0.59|0.589
71870953|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.067||0.0722|TWO_SIDED|95.0|-0.25|0.01|||Mixed Models Analysis|||Month 1, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.25|0.0722
71870954|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.055||0.0035|TWO_SIDED|95.0|-0.27|-0.05|||Mixed Models Analysis|||Month 1, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.05|-0.27|0.0035
71870955|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.069||0.0475|TWO_SIDED|95.0|-0.27|0.0|||Mixed Models Analysis|||Month 1, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.27|0.0475
71870956|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.066||0.0537|TWO_SIDED|95.0|-0.26|0.0|||Mixed Models Analysis|||Month 1, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.00|-0.26|0.0537
71870957|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.062||0.1977|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|||Month 1, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.04|-0.20|0.1977
71870958|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064||0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed Models Analysis|||Month 3, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.13|-0.38|0.0001
71870959|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.057||0.0018|TWO_SIDED|95.0|-0.29|-0.07|||Mixed Models Analysis|||Month 3, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.07|-0.29|0.0018
71870960|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.47|-0.19|||Mixed Models Analysis|||Month 3, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.19|-0.47|<0.0001
71914464|NCT02845440|143350383|SUPERIORITY||Odds Ratio (OR)|3.05|||<|0.001|TWO_SIDED|95.0|1.99|4.68||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||4.68|1.99|<0.001
71870961|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.073||0.0002|TWO_SIDED|95.0|-0.42|-0.14|||Mixed Models Analysis|||Month 3, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-0.14|-0.42|0.0002
71870962|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.063||0.0835|TWO_SIDED|95.0|-0.23|0.01|||Mixed Models Analysis|||Month 3, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.23|0.0835
71870963|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.056||0.0825|TWO_SIDED|95.0|-0.21|0.01|||Mixed Models Analysis|||Month 6, Mobility: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.21|0.0825
71870964|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.049||0.5616|TWO_SIDED|95.0|-0.13|0.07|||Mixed Models Analysis|||Month 6, Self-Care: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.07|-0.13|0.5616
71870965|NCT03486457|143259064|SUPERIORITY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.065||0.0748|TWO_SIDED|95.0|-0.24|0.01|||Mixed Models Analysis|||Month 6, Usual Activities: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.01|-0.24|0.0748
71870966|NCT03486457|143259064|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.9477|TWO_SIDED|95.0|-0.15|0.16|||Mixed Models Analysis|||Month 6, Pain/Discomfort: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.16|-0.15|0.9477
71914465|NCT02845440|143350383|SUPERIORITY||Odds Ratio (OR)|0.89||||0.698|TWO_SIDED|95.0|0.51|1.57||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept.||1.57|0.51|0.698
71870967|NCT03486457|143259064|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.067||0.3829|TWO_SIDED|95.0|-0.07|0.19|||Mixed Models Analysis|||Month 6, Anxiety/Depression: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||0.19|-0.07|0.3829
71870968|NCT03486457|143259065|SUPERIORITY||LS mean difference|6.01|STANDARD_ERROR_OF_MEAN|2.084||0.0044|TWO_SIDED|95.0|1.9|10.12|||Mixed Models Analysis|||Month 1: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||10.12|1.90|0.0044
71870969|NCT03486457|143259065|SUPERIORITY||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|2.578|<|0.0001|TWO_SIDED|95.0|5.71|15.88|||Mixed Models Analysis|||Month 3: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||15.88|5.71|<0.0001
71870970|NCT03486457|143259065|SUPERIORITY||LS mean difference|0.92|STANDARD_ERROR_OF_MEAN|2.442||0.7062|TWO_SIDED|95.0|-3.9|5.74|||Mixed Models Analysis|||Month 6: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.74|-3.90|0.7062
71914466|NCT02845440|143350383|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Odds Ratio (OR)|1.1||||0.845|TWO_SIDED|95.0|0.43|2.78|||Regression, Logistic|||The statistical model was a mixed effects logistic regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept.||2.78|0.43|0.845
71914467|NCT02845440|143350384|SUPERIORITY||Odds Ratio (OR)|1.42||||0.158|TWO_SIDED|95.0|0.92|2.2||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as TUD medication use and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of TUD medication use on abstinence rates attributable to the CHW intervention was 55.6%.|2.20|0.92|0.158
71914468|NCT02845440|143350385|SUPERIORITY||Odds Ratio (OR)|1.89||||0.013|TWO_SIDED|95.0|1.14|3.13||The a priori threshold for significance was a p-value \< 0.05.|Regression, Logistic|||Missing abstinence rates at year 2 of intervention were imputed using MICE based on baseline characteristics and abstinence rates at year 1 of intervention. The statistical model was a mixed effects logistic regression with terms for the factorial design (TAU, AD, CHW, and cohort) as well as varenicline use and a clinic-varying random intercept. Regression coefficients and mediation analysis estimates were pooled using Rubin's rule over 10 imputation runs.|A mediation analysis found that the estimated proportion of the effect of varenicline use on abstinence rates attributable to the CHW intervention was 36.6%.|3.13|1.14|0.013
71914469|NCT02845440|143350386|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.505|TWO_SIDED|95.0|-0.16|0.33|||Regression, Linear|||The model had a clinic varying random intercept. This statistical model included cohort 1: TAU , AD, and AD+CHW||0.33|-0.16|0.505
71914470|NCT02845440|143350386|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.848|TWO_SIDED|95.0|-0.22|0.27||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.27|-0.22|0.848
71914471|NCT02845440|143350386|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.529|TWO_SIDED|95.0|-0.13|0.25||The a priori threshold for significance was a p-value \< 0.05.|Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for TAU, AD, and AD+CHW (cohort 1) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.25|-0.13|0.529
71914472|NCT02845440|143350387|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.937|TWO_SIDED|95.0|-0.16|0.18|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.18|-0.16|0.937
71914473|NCT02845440|143350387|SUPERIORITY||Median Difference (Final Values)|0.05||||0.683|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with terms for the factorial design (TAU, AD, CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.29|-0.19|0.683
71914474|NCT02845440|143350387|OTHER|Test of the additive assumption required by a factorial design. If the AD x CHW interaction is significant at p \< 0.05, the additive assumption would have to be rejected.|Mean Difference (Final Values)|0.3||||0.19|TWO_SIDED|95.0|-0.15|0.74|||Regression, Linear|||Missing data at year 2 of intervention was imputed using MICE based on baseline characteristics and outcome values at year 1 of intervention. The statistical model was a mixed effects linear regression with both additive terms and an interaction (TAU, AD, CHW, AD x CHW, and cohort) and a clinic-varying random intercept. Regression coefficients were pooled using Rubin's rule over 10 imputation runs.||0.74|-0.15|0.190
71914475|NCT02057068|143350388|SUPERIORITY||||||<|0.001|||||||ANOVA|Intention to treat analysis with last observation carried forward|||Partial Eta Squared = .282|||<.001
71914476|NCT02057068|143350389|SUPERIORITY|Intention to treat analysis with last observation carried forward|||||>|0.05|||||||ANOVA|||||||>.05
71914477|NCT02057068|143350390|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71914478|NCT01024920|143350409|OTHER|||||||0.8531||||||P-value for comparison of Kaplan-Meier estimates at 9 months using normal approximation test (two-sided).|Normal approximation test|||||||0.8531
71914479|NCT01024920|143350411|OTHER||Hazard Ratio (HR)|1.12||||0.6395|TWO_SIDED|95.0|0.697|1.8|||Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery.|A stratified log-rank test (two-sided, 0.05 significance level) was used to test the effect of nintedanib on PFS compared with sunitinib. The test was stratified by Motzer risk score category (low/intermediate or high) and prior nephrectomy surgery for Renal Cell Cancer (yes or no).||1.800|0.697|0.6395
71914480|NCT01024920|143350412|OTHER||Odds Ratio (OR)|0.484||||0.1213|TWO_SIDED|95.0|0.193|1.212|||Regression, Logistic||Odds ratio \> 1 favours nintedanib.|A logistic regression model stratified by Motzer risk score category and prior surgery for renal cell cancer (RCC) was used to compare the objective response rate between the two treatment arms. The corresponding odds ratio and 95% Confidence Intervals was also presented.||1.212|0.193|0.1213
71914481|NCT01024920|143350414|OTHER||Hazard Ratio (HR)|0.92||||0.7593|TWO_SIDED|95.0|0.542|1.564||P-value from log-rank stratified by Motzer risk score and previous surgery.|Log Rank||Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.564|0.542|0.7593
71914482|NCT01024920|143350415|OTHER||Cox Proportional Hazard|1.143||||0.5958|TWO_SIDED|95.0|0.697|1.873|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery.|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.873|0.697|0.5958
71914483|NCT01024920|143350416|OTHER||Hazard Ratio (HR)|1.142||||0.5712|TWO_SIDED|95.0|0.72|1.812|||Log Rank|P-value from log-rank stratified by Motzer risk score and previous surgery (two-sided).|Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \< 1 favours nintedanib.|||1.812|0.720|0.5712
71914484|NCT02977507|143350452|OTHER|||||||0.041|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.041
71914485|NCT02977507|143350452|OTHER|||||||0.0005|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0005
71914486|NCT02977507|143350453|OTHER|||||||0.002|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.002
71914487|NCT02977507|143350453|OTHER|||||||0.0001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0001
71914488|NCT02977507|143350454|OTHER|||||||0.004|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.004
71914489|NCT02977507|143350454|OTHER|||||||0.001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.001
71914490|NCT02977507|143350458|OTHER|||||||0.003|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.003
71914491|NCT02977507|143350458|OTHER|||||||0.0007|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.||||0.0007
71914492|NCT02977507|143350460|OTHER|||||||0.569|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.569
71914493|NCT02977507|143350460|OTHER|||||||9e-05|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.00009
71914494|NCT02977507|143350460|OTHER|||||||0.821|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.821
71914495|NCT02977507|143350460|OTHER|||||||0.502|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.502
71914496|NCT02977507|143350460|OTHER|||||||0.81|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.||||0.810
71914497|NCT02977507|143350460|OTHER|||||||0.435|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.||||0.435
71914498|NCT00633360|143350461|SUPERIORITY_OR_OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||.59
71914499|NCT00633360|143350462|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||.29
71914500|NCT00471276|143350485|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|8.4|||||TWO_SIDED|95.0|3.5|16.6|||Exact 2-sided confidence interval|||||16.6|3.5|
71914501|NCT00471276|143350486|SUPERIORITY_OR_OTHER||Objective Response Rate (percent)|10.8|||||TWO_SIDED|95.0|5.1|19.6|||Exact 2-sided confidence interval|||||19.6|5.1|
71870971|NCT03486457|143259066|SUPERIORITY||LS mean difference|0.86|STANDARD_ERROR_OF_MEAN|2.404||0.7228|TWO_SIDED|95.0|-3.92|5.63|||Mixed Models Analysis|||Month 3, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||5.63|-3.92|0.7228
71870972|NCT03486457|143259066|SUPERIORITY||LS mean difference|-6.34|STANDARD_ERROR_OF_MEAN|4.561||0.1682|TWO_SIDED|95.0|-15.39|2.72|||Mixed Models Analysis|||Month 3, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||2.72|-15.39|0.1682
71870973|NCT03486457|143259066|SUPERIORITY||LS mean difference|-6.21|STANDARD_ERROR_OF_MEAN|4.707||0.19|TWO_SIDED|95.0|-15.56|3.13|||Mixed Models Analysis|||Month 3, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||3.13|-15.56|0.1900
71870974|NCT03486457|143259066|SUPERIORITY||LS mean difference|-1.08|STANDARD_ERROR_OF_MEAN|2.581||0.6757|TWO_SIDED|95.0|-6.22|4.05|||Mixed Models Analysis|||Month 6, Work Time Missed: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||4.05|-6.22|0.6757
71870975|NCT03486457|143259066|SUPERIORITY||LS mean difference|-2.38|STANDARD_ERROR_OF_MEAN|4.905||0.6285|TWO_SIDED|95.0|-12.13|7.37|||Mixed Models Analysis|||Month 6, Impairment While Working: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.37|-12.13|0.6285
71870976|NCT03486457|143259066|SUPERIORITY||LS mean difference|-2.63|STANDARD_ERROR_OF_MEAN|5.333||0.6228|TWO_SIDED|95.0|-13.23|7.97|||Mixed Models Analysis|||Month 6, Overall Work Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.97|-13.23|0.6228
71870977|NCT03486457|143259067|SUPERIORITY||LS mean difference|-12.81|STANDARD_ERROR_OF_MEAN|3.089|<|0.0001|TWO_SIDED|95.0|-18.9|-6.72|||Mixed Models Analysis|||Month 3, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||-6.72|-18.90|<0.0001
71870978|NCT03486457|143259067|SUPERIORITY||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|3.157||0.7384|TWO_SIDED|95.0|-5.17|7.28|||Mixed Models Analysis|||Month 6, Activity Impairment: Analysis performed using MMRM which included the fixed effect of treatment, visit, treatment by visit interaction, and baseline value.||7.28|-5.17|0.7384
71870979|NCT02943226|143259089|SUPERIORITY|||||||0.4487|||||||two sample t-test|||||||0.4487
71870980|NCT02943226|143259090|SUPERIORITY|||||||0.0112|||||||Wilcoxon (Mann-Whitney)|||||||0.0112
71870981|NCT02943226|143259091|SUPERIORITY|||||||0.0784|||||||two sample t-test|||||||0.0784
71870982|NCT01602562|143259092|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|16.11|||||The estimated value reflects the percentage of participants with an HSV infection.|||16.11|0.00|
71870983|NCT01602562|143259092|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|17.65|||||The estimated value reflects the percentage of participants with an HSV infection.|||17.65|0.00|
71870984|NCT03881553|143259107|OTHER|Non-parametric Friedmans||||||0.081||||||χ2 =5.03|Friedman's|||||||0.081
71870985|NCT03881553|143259107|OTHER|Post hoc: Wilcoxon||||||0.05||||||ON1 compared to OFF1|Wilcoxon (Mann-Whitney)|||||||0.05
71914502|NCT01594411|143350505|SUPERIORITY_OR_OTHER||||||<|0.001|||||||one-sided binomial with alpha level of 0|||"The proportion of patients whose final treatment plan changes from the preliminary will be estimated, and a one-sided binomial test with alpha level of .05 will be used to test whether it is greater than 10%.~This is the level at which it is assumed that patient management has been modified by a practically important amount."||||<0.001
71870986|NCT03881553|143259107|OTHER|Post Hoc Wilcoxon||||||0.021||||||ON1 compared to OFF2|Wilcoxon (Mann-Whitney)|||||||0.021
71870987|NCT01959516|143259111|SUPERIORITY_OR_OTHER|||||||0.025|||||||Mixed Models Analysis|||||||0.0250
71870988|NCT01959516|143259112|SUPERIORITY_OR_OTHER|||||||0.1439|||||||Mixed Models Analysis|||||||0.1439
71870989|NCT04217590|143259241|SUPERIORITY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|1.9|15.12|||Fisher Exact||The CI for OR is calculated as an exact CI. An OR \> 1 favours SZC.|||15.12|1.90|<0.001
71870990|NCT04217590|143259242|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.64|15.55|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.55|2.64|<0.001
71870991|NCT04217590|143259243|SUPERIORITY||Odds Ratio (OR)|6.41|||<|0.001|TWO_SIDED|95.0|2.71|15.12|||Regression, Logistic|The OR, 95% CI and p-value are obtained from a pooled logistic regression model after multiple imputation (MI) of missing pre-dialysis S-K values.|An OR \> 1 favours SZC.|||15.12|2.71|<0.001
71870992|NCT04217590|143259244|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.53|7.67|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||7.67|2.53|<0.001
71870993|NCT04217590|143259245|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.77|1.64|||||Endpoint analysed with Generalised linear mixed model. The CI for the mean difference was calculated by bootstrapping. A mean difference \> 0 favours SZC.|||1.64|0.77|
71870994|NCT04217590|143259246|SUPERIORITY||Odds Ratio (OR)|5.82|||<|0.001|TWO_SIDED|95.0|3.15|10.73|||Generalised linear mixed model (GLMM)|The p-value was obtained from a test of equality of odds ratios.|The OR was obtained from GLMM model with random intercept and logit link. Treatment, visit, visit by treatment interaction and baseline were specified as fixed effects. An OR \> 1 favours SZC.|||10.73|3.15|<0.001
71870995|NCT04619251|143259248|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|337.6|||||TWO_SIDED|90.0|302.8|376.4|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =15.9|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||376.4|302.8|
71914503|NCT01620593|143350507|SUPERIORITY|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71870996|NCT04619251|143259249|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|184.4|||||TWO_SIDED|90.0|156.0|218.0|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =26.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||218.0|156.0|
71870997|NCT04619251|143259250|OTHER|Since the main focus is on estimation and not testing, a formal hypothesis test and associated acceptance range is not specified.|Geometric Least Squares Mean ratio (%)|356.8|||||TWO_SIDED|90.0|315.7|403.2|||||Geometric Least Squares Mean ratio was estimated by the ratios of the geometric means (T/R). Intra-individual geometric coefficient variation (gCV %) =18.4|The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: subject and treatment. The effect 'subject' was considered as random, whereas the effect 'treatment' was considered as fixed. These quantities were then back-transformed to the original scale.||403.2|315.7|
71870998|NCT00803751|143259259|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Fisher Exact|||||||0.17
71870999|NCT00803751|143259260|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||Fisher Exact|||||||0.45
71871000|NCT00803751|143259261|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
71871001|NCT00803751|143259262|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
71871002|NCT00803751|143259263|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71871003|NCT00803751|143259264|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||t-test, 2 sided|||||||0.0004
71871004|NCT03102645|143259269|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.07|TWO_SIDED|95.0|-0.5|13.5|||t-test, 2 sided|CROS. DF=14.||CROS test||13.5|-0.5|0.07
71871005|NCT03102645|143259270|SUPERIORITY||Mean Difference (Final Values)|15.2||||0.03|TWO_SIDED|95.0|2.0|28.2|||t-test, 2 sided|CROS test||CROS test||28.2|2.0|0.03
71871006|NCT01413087|143259271|SUPERIORITY|||||||0.483|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.483
71871007|NCT01413087|143259272|SUPERIORITY|||||||0.992|||||||Log Rank|P value by log-rank test for the difference between treatment groups||||||0.992
71871008|NCT00704405|143259284|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|53.6|||<|0.001|TWO_SIDED|95.0|34.5|69.1|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||69.1|34.5|<0.001
71871009|NCT00704405|143259284|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|64.4|||<|0.001|TWO_SIDED|95.0|45.2|78.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||78.3|45.2|<0.001
71871010|NCT00704405|143259284|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|59.0|||<|0.001|TWO_SIDED|95.0|40.2|73.4|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||73.4|40.2|<0.001
71871011|NCT00704405|143259287|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|47.3|||<|0.001|TWO_SIDED|95.0|29.2|63.2|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.|||63.2|29.2|<0.001
71871012|NCT00704405|143259288|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|82.6|||||TWO_SIDED|95.0|69.5|90.2|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||90.2|69.5|
71871013|NCT00704405|143259288|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|76.1|||||TWO_SIDED|95.0|60.1|86.7|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.|||86.7|60.1|
71871014|NCT00704405|143259289|SUPERIORITY_OR_OTHER||Adjusted difference in percentage|35.8|||||TWO_SIDED|95.0|15.5|53.4|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.|||53.4|15.5|
71871015|NCT01395888|143259290|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.259||||0.484|TWO_SIDED|95.0|-0.468|0.986|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.986|-0.468|0.484
71871016|NCT00998335|143259314|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||ANOVA|||Baseline versus 3 months||||0.03
71871017|NCT00346268|143259346|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-7.58|STANDARD_ERROR_OF_MEAN|3.55||0.035|TWO_SIDED|95.0|-14.63|-0.53||Adjusted for treatment group and center|ANOVA|||||-0.53|-14.63|0.035
71871018|NCT00346268|143259347|SUPERIORITY_OR_OTHER||least square (LS) mean difference (net)|-15.16|STANDARD_ERROR_OF_MEAN|5.2||0.004|TWO_SIDED|95.0|-25.47|-4.85||Adjusted for treatment group and center|ANOVA|||||-4.85|-25.47|0.004
71871019|NCT00346268|143259348|SUPERIORITY_OR_OTHER|||||||0.257||95.0|||||Log Rank|Stratified by center||||||0.257
71871020|NCT00346268|143259349|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.07|STANDARD_ERROR_OF_MEAN|0.3||0.81|TWO_SIDED|95.0|-0.68|0.53||Adjusted for treatment group and center|ANCOVA|Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume||||0.53|-0.68|0.810
71871021|NCT00346268|143259351|SUPERIORITY_OR_OTHER||Least squares mean difference (net)|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED|95.0|-0.01|0.35|||ANOVA|||The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.||0.35|-0.01|0.070
71871022|NCT00346268|143259351|SUPERIORITY_OR_OTHER||LS Mean Difference (net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.074|TWO_SIDED|95.0|-0.02|0.33|||ANOVA|||The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.||0.33|-0.02|0.074
71871023|NCT00346268|143259352|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.71|STANDARD_ERROR_OF_MEAN|0.23||0.002|TWO_SIDED|95.0|-1.16|-0.26||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.26|-1.16|0.002
71871024|NCT00346268|143259352|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.73|STANDARD_ERROR_OF_MEAN|0.25||0.004|TWO_SIDED|95.0|-1.22|-0.23||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.23|-1.22|0.004
71683191|NCT05079230|142884470|SUPERIORITY||Stratified Odds Ratio|0.783||||0.3003|TWO_SIDED|95.0|0.492|1.245|||Cochran-Mantel-Haenszel||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|||1.245|0.492|0.3003
71871025|NCT00346268|143259353|SUPERIORITY_OR_OTHER||LS mean difference (net)|-1.16|STANDARD_ERROR_OF_MEAN|0.3||0.001|TWO_SIDED|95.0|-1.77|-0.56||Adjusted for treatment group and center|ANOVA|||24 hours post surgery||-0.56|-1.77|0.001
71871026|NCT00346268|143259353|SUPERIORITY_OR_OTHER||LS mean difference (net)|-0.83|STANDARD_ERROR_OF_MEAN|0.3||0.006|TWO_SIDED|95.0|-1.41|-0.24||Adjusted for treatment group and center|ANOVA|||48 hours post surgery||-0.24|-1.41|0.006
71871027|NCT00252733|143259369|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.821||||0.0508|TWO_SIDED|95.0|0.673|1.001|||Log Rank|Generalized||||1.001|0.673|0.0508
71871028|NCT01350336|143259371|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 2 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.038|||||TWO_SIDED|95.0|-0.1251|0.0497||||||Comparison of Years 1 and 2||0.0497|-0.1251|
71871029|NCT01350336|143259371|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 3 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0325|||||TWO_SIDED|95.0|-0.1197|0.0565||||||Comparison of Years 1 and 3||0.0565|-0.1197|
71871030|NCT01350336|143259371|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 4 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0566|||||TWO_SIDED|95.0|-0.1444|0.0329||||||Comparison of Years 1 and 4||0.0329|-0.1444|
71871031|NCT01350336|143259371|NON_INFERIORITY|An upper 95% confidence limit of the difference between Year 5 compared to the first 12-month proportion is less than 20% will demonstrate that the proportions are not substantially worse during each of the subsequent evaluation periods.|Difference of proportions|-0.0765|||||TWO_SIDED|95.0|-0.1661|0.013||||||Comparison of Years 1 and 5||0.0130|-0.1661|
71871032|NCT02079610|143259385|SUPERIORITY||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|3.93|<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71871033|NCT02079610|143259386|SUPERIORITY||Mean Difference (Final Values)|8.2|STANDARD_DEVIATION|5.2||0.03|TWO_SIDED||||||Mixed Models Analysis|||||||0.03
71871034|NCT02079610|143259387|SUPERIORITY||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|3.5||0.01|TWO_SIDED||||||Mixed Models Analysis|||||||0.01
71871035|NCT01016977|143259390|SUPERIORITY_OR_OTHER|||||||0.9597||95.0||||Week 1|ANCOVA|||||||0.9597
71871036|NCT01016977|143259390|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 2|ANCOVA|||||||0.5538
71871037|NCT01016977|143259390|SUPERIORITY_OR_OTHER|||||||0.6315||95.0||||Week 4|ANCOVA|||||||0.6315
71871038|NCT01016977|143259390|SUPERIORITY_OR_OTHER|||||||0.5655||95.0||||Week 8|ANCOVA|||||||0.5655
71871039|NCT01016977|143259390|SUPERIORITY_OR_OTHER|||||||0.7917||95.0||||Week 12|ANCOVA|||||||0.7917
71871040|NCT01016977|143259391|SUPERIORITY_OR_OTHER|||||||0.5961||95.0||||Week 1|ANCOVA|||||||0.5961
71871041|NCT01016977|143259391|SUPERIORITY_OR_OTHER|||||||0.2293||95.0||||Week 2|ANCOVA|||||||0.2293
71871042|NCT01016977|143259391|SUPERIORITY_OR_OTHER|||||||0.9852||95.0||||Week 4|ANCOVA|||||||0.9852
71871043|NCT01016977|143259391|SUPERIORITY_OR_OTHER|||||||0.5538||95.0||||Week 8|ANCOVA|||||||0.5538
71871044|NCT01016977|143259391|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
71871045|NCT01016977|143259392|SUPERIORITY_OR_OTHER|||||||0.8545||95.0||||Week 1|ANCOVA|||||||0.8545
71871046|NCT01016977|143259392|SUPERIORITY_OR_OTHER|||||||0.2895||95.0||||Week 2|ANCOVA|||||||0.2895
71871047|NCT01016977|143259392|SUPERIORITY_OR_OTHER|||||||0.8234||95.0||||Week 4|ANCOVA|||||||0.8234
71871048|NCT01016977|143259392|SUPERIORITY_OR_OTHER|||||||0.3644||95.0||||Week 8|ANCOVA|||||||0.3644
71871049|NCT01016977|143259392|SUPERIORITY_OR_OTHER|||||||0.654||95.0||||Week 12|ANCOVA|||||||0.6540
71871050|NCT01016977|143259393|SUPERIORITY_OR_OTHER|||||||0.7546||95.0||||Week 1|ANCOVA|||||||0.7546
71871051|NCT01016977|143259393|SUPERIORITY_OR_OTHER|||||||0.7705||95.0||||Week 2|ANCOVA|||||||0.7705
71871052|NCT01016977|143259393|SUPERIORITY_OR_OTHER|||||||0.0259||95.0||||Week 4|ANCOVA|||||||0.0259
71871053|NCT01016977|143259393|SUPERIORITY_OR_OTHER|||||||0.9252||95.0||||Week 8|ANCOVA|||||||0.9252
71871054|NCT01016977|143259393|SUPERIORITY_OR_OTHER|||||||0.2927||95.0||||Week 12|ANCOVA|||||||0.2927
71871055|NCT01016977|143259394|SUPERIORITY_OR_OTHER|||||||0.401||95.0||||Week 1|ANCOVA|||||||0.4010
71871056|NCT01016977|143259394|SUPERIORITY_OR_OTHER|||||||0.0963||95.0||||Week 2|ANCOVA|||||||0.0963
71871057|NCT01016977|143259394|SUPERIORITY_OR_OTHER|||||||0.9291||95.0||||Week 4|ANCOVA|||||||0.9291
71871058|NCT01016977|143259394|SUPERIORITY_OR_OTHER|||||||0.5523||95.0||||Week 8|ANCOVA|||||||0.5523
71871059|NCT01016977|143259394|SUPERIORITY_OR_OTHER|||||||0.2556||95.0||||Week 12|ANCOVA|||||||0.2556
71871060|NCT01016977|143259395|SUPERIORITY_OR_OTHER|||||||0.4037||95.0||||Week 1|ANCOVA|||||||0.4037
71871061|NCT01016977|143259395|SUPERIORITY_OR_OTHER|||||||0.8662||95.0||||Week 2|ANCOVA|||||||0.8662
71871062|NCT01016977|143259395|SUPERIORITY_OR_OTHER|||||||0.5951||95.0||||Week 4|ANCOVA|||||||0.5951
71871063|NCT01016977|143259395|SUPERIORITY_OR_OTHER|||||||0.2349||95.0||||Week 8|ANCOVA|||||||0.2349
71871064|NCT01016977|143259395|SUPERIORITY_OR_OTHER|||||||0.3461||95.0||||Week 12|ANCOVA|||||||0.3461
71871065|NCT01016977|143259396|SUPERIORITY_OR_OTHER|||||||0.725||95.0||||Week 1|ANCOVA|||||||0.7250
71871066|NCT01016977|143259396|SUPERIORITY_OR_OTHER|||||||0.9743||95.0||||Week 2|ANCOVA|||||||0.9743
71871067|NCT01016977|143259396|SUPERIORITY_OR_OTHER|||||||0.9816||95.0||||Week 4|ANCOVA|||||||0.9816
71871068|NCT01016977|143259396|SUPERIORITY_OR_OTHER|||||||0.8809||95.0||||Week 8|ANCOVA|||||||0.8809
71914504|NCT00880607|143350539|OTHER|Wilcoxon rank-sum test because the outcome variable was found to have a skewed distribution.|Median Difference (Final Values)|7.7||||0.27|TWO_SIDED|95.0|-5.8|21.2||Hodges-Lehmanne estimation method|Wilcoxon (Mann-Whitney)||Hodges-Lehmanne estimation method|||21.2|-5.8|.27
71871069|NCT01016977|143259396|SUPERIORITY_OR_OTHER|||||||0.1679||95.0||||Week 12|ANCOVA|||||||0.1679
71871070|NCT00477334|143259410|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.26||||0.4161|TWO_SIDED|95.0|-0.4|0.98|||Hodges-Lehman Shift Model||Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)||0.98|-0.40|0.4161
71871071|NCT00477334|143259410|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.01||||0.9372|TWO_SIDED|95.0|0.74|1.39|||Kaplan-Meier & Cox Regression||"Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.~Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables."|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.||1.39|0.74|0.9372
71871072|NCT00372229|143259449|SUPERIORITY_OR_OTHER_LEGACY||Difference|-28.5|STANDARD_ERROR_OF_MEAN|5.45|||TWO_SIDED|96.0|-39.7|-17.3||||||||-17.3|-39.7|
71871073|NCT00372229|143259450|SUPERIORITY_OR_OTHER_LEGACY||Difference|-11.3|STANDARD_ERROR_OF_MEAN|3.83|||TWO_SIDED|96.0|-19.2|-3.4||||||||-3.4|-19.2|
71871074|NCT00372229|143259451|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2509|STANDARD_ERROR_OF_MEAN|0.1838||0.1739|TWO_SIDED|99.0|-0.2271|0.7289|||F-test|||||0.7289|-0.2271|0.1739
71871075|NCT00372229|143259484|OTHER|Descriptive analysis|Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.71|||TWO_SIDED|95.0|-20.2|13.9||||||||13.9|-20.2|
71871076|NCT00372229|143259485|OTHER|Descriptive analysis|Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.21|||TWO_SIDED|95.0|-0.1|24.2||||||||24.2|-0.1|
71871077|NCT03536143|143259494|SUPERIORITY|||||||0.0216|||||||Log Rank|||||||0.0216
71871078|NCT03536143|143259495|SUPERIORITY|||||||0.0009|||||||Log Rank|||||||0.0009
71871079|NCT03406260|143259529|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.63|||<|0.0001|TWO_SIDED|95.0|-1000.0|1.81|||Linear Mixed Effects Model|||||1.81|-1000|<0.0001
71871080|NCT03406260|143259529|NON_INFERIORITY|A p-value \< 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.35|||<|0.0001|TWO_SIDED|95.0|-1000.0|2.06|||Linear Mixed Effects Model|||||2.06|-1000|<0.0001
71871081|NCT00871780|143259532|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0003
71871082|NCT00871780|143259532|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0002
71871083|NCT00871780|143259533|SUPERIORITY_OR_OTHER|||||||0.0148|||||||Wilcoxon signed rank test|||Baseline, Week 24||||0.0148
71871084|NCT00871780|143259533|SUPERIORITY_OR_OTHER|||||||0.0119|||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0119
71871085|NCT00871780|143259534|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
71871086|NCT00871780|143259534|SUPERIORITY_OR_OTHER|||||||0.0157|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||0.0157
71871087|NCT00871780|143259535|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 24||||<0.0001
71871088|NCT00871780|143259535|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon signed rank test|||Baseline, Week 48||||<0.0001
71871089|NCT00871780|143259536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
71871090|NCT00871780|143259536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
71871091|NCT00871780|143259536|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
71871092|NCT00871780|143259537|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
71871093|NCT00871780|143259537|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
71871094|NCT00871780|143259537|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
71871095|NCT00871780|143259538|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
71871096|NCT00871780|143259538|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
71871097|NCT00871780|143259538|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
71871098|NCT00871780|143259539|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
71871099|NCT00871780|143259539|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
71871100|NCT00871780|143259539|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
71871101|NCT00871780|143259540|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
71871102|NCT00871780|143259540|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||<0.0001
71871103|NCT00871780|143259540|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||<0.0001
71871104|NCT00871780|143259541|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
71871105|NCT00871780|143259541|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
71871106|NCT00871780|143259541|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
71871107|NCT00871780|143259542|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Pearson Correlation|||Baseline||||<0.0001
71871108|NCT00871780|143259542|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 24||||0.0016
71871109|NCT00871780|143259542|SUPERIORITY_OR_OTHER|||||||0.0866|TWO_SIDED||||||Pearson Correlation|||Change from Baseline at Week 48||||0.0866
71871110|NCT00871780|143259543|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Baseline||||<0.0001
71871111|NCT00871780|143259543|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 24||||<0.0001
71871112|NCT00871780|143259543|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Spearman correlation|||Change from Baseline at Week 48||||<0.0001
71871113|NCT02527343|143259545|SUPERIORITY||Difference in Least Square Mean|-66.83||||0.0009|TWO_SIDED|95.0|-104.17|-29.48|||ANCOVA|||||-29.48|-104.17|0.0009
71871114|NCT02527343|143259546|SUPERIORITY||Difference in Least Square Mean|-25.69||||0.0736|TWO_SIDED|95.0|-54.03|2.65|||ANCOVA|||Month 6||2.65|-54.03|0.0736
71871115|NCT02527343|143259546|SUPERIORITY||Difference in Least Square Mean|-53.33||||0.0039|TWO_SIDED|95.0|-87.71|-18.95|||ANCOVA|||Month 12||-18.95|-87.71|0.0039
71871116|NCT02527343|143259548|SUPERIORITY||Difference in Least Square Mean|0.3||||0.4108|TWO_SIDED|95.0|-0.43|1.03|||ANCOVA|||Month 3||1.03|-0.43|0.4108
71871117|NCT02527343|143259548|SUPERIORITY||Difference in Least Square Mean|0.19||||0.7308|TWO_SIDED|95.0|-0.95|1.34|||ANCOVA|||Month 6||1.34|-0.95|0.7308
71871118|NCT02527343|143259548|SUPERIORITY||Difference in Least Square Mean|-0.2||||0.7511|TWO_SIDED|95.0|-1.45|1.06|||ANCOVA|||Month 9||1.06|-1.45|0.7511
71871119|NCT02527343|143259548|SUPERIORITY||Difference in Least Square Mean|-0.19||||0.7659|TWO_SIDED|95.0|-1.52|1.13|||ANCOVA|||Month 12||1.13|-1.52|0.7659
71871120|NCT00701220|143259562|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||The data were analyzed using analysis of variance for repeated measures with two groups. The repeated measure was the proportion of circulating blood cells that were positive for aldehyde dehydrogenase using the commercially available Aldofluor assay. The two groups were those with ischemic and non-ischemic cardiomyopathy. This analysis permitted both intergroup and intragroup analysis of the change in aldehyde dehydrogenase positive cells.||||<0.05
71871121|NCT01205152|143259564|OTHER|||||||0.002||||||Two-sided with p-value threshold \<0.05 for statistical significance.|Wilcoxon signed-rank test|||Change is relative to Baseline in Study ENB-002-08 (NCT00744042). The RGI-C score represents evaluation of skeletal X-rays at each post-treatment study timepoint compared with pre-treatment X-rays from Study ENB-002-08 using an ordinal scale. Therefore, an RGI-C score is not applicable for radiographs obtained at Baseline.||||0.0020
71871122|NCT00116337|143259583|OTHER|Statistical analyses was performed using a repeated measures analysis of variance and Paired t test. A p value of \< 0.05 was taken as indicating statistical significance.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.||||<0.05
71871123|NCT00116337|143259585|OTHER||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P\<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.||||<0.05
71871124|NCT02483585|143259619|SUPERIORITY|A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.|LS Mean Difference|-1.04|||<|0.001|TWO_SIDED|95.0|-1.61|-0.47|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.47|-1.61|< 0.001
71871125|NCT02483585|143259620|SUPERIORITY||Odds Ratio (OR)|1.59||||0.01|TWO_SIDED|95.0|1.12|2.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||2.27|1.12|0.010
71914505|NCT00880607|143350540|OTHER|Log-rank test in Kaplan-Meier used.||||||0.42|TWO_SIDED|95.0|||||Log Rank|||||||.42
71914506|NCT00880607|143350542|OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71914507|NCT00880607|143350543|OTHER|||||||0.3|||||||Chi-squared|||||||0.30
71914508|NCT00880607|143350544|OTHER|||||||0.07|||||||Chi-squared|||||||0.07
71914509|NCT00880607|143350545|OTHER|||||||0.31|||||||Chi-squared|||||||0.31
71914510|NCT02963766|143350548|SUPERIORITY||LS Mean difference (Final Values)|-1.3|||<|0.001|TWO_SIDED|95.0|-1.8|-0.7|||Mixed Models Analysis|||||-0.7|-1.8|<0.001
71914511|NCT02963766|143350549|SUPERIORITY||LS Mean difference (Final Values)|-1.0||||0.002|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||||-0.4|-1.7|0.002
71914512|NCT02963766|143350549|SUPERIORITY||LS Mean difference (Final Values)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.2|-0.9|||Mixed Models Analysis|||||-0.9|-2.2|<0.001
71871126|NCT02483585|143259621|SUPERIORITY||LS Mean Difference|-0.59||||0.002|TWO_SIDED|95.0|-0.96|-0.21|||Generalized Linear Mixed Model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.||-0.21|-0.96|0.002
71871127|NCT02483585|143259622|SUPERIORITY||Odds Ratio (OR)|1.22||||0.26|TWO_SIDED|95.0|0.87|1.71|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.71|0.87|0.26
71914513|NCT02963766|143350550|SUPERIORITY||LS Mean difference (Final Values)|-1.44||||0.021|TWO_SIDED|95.0|-2.65|-0.22|||Mixed Models Analysis|||||-0.22|-2.65|0.021
71914514|NCT02963766|143350550|SUPERIORITY||LS Mean difference (Final Values)|-2.51|||<|0.001|TWO_SIDED|95.0|-3.72|-1.29|||Mixed Models Analysis|||||-1.29|-3.72|<0.001
71914515|NCT02963766|143350550|SUPERIORITY||LS Mean difference (Final Values)|-1.97|||<|0.001|TWO_SIDED|95.0|-3.03|-0.91|||Mixed Models Analysis|||||-0.91|-3.03|<0.001
71914516|NCT02963766|143350551|SUPERIORITY||Odds Ratio (OR)|11.038|||<|0.001|TWO_SIDED|95.0|3.491|34.902|||Regression, Logistic|||||34.902|3.491|<0.001
71914517|NCT02963766|143350551|SUPERIORITY||Odds Ratio (OR)|11.666|||<|0.001|TWO_SIDED|95.0|3.653|37.253|||Regression, Logistic|||||37.253|3.653|<0.001
71914518|NCT02963766|143350551|SUPERIORITY||Odds Ratio (OR)|11.348|||<|0.001|TWO_SIDED|95.0|4.163|30.932|||Regression, Logistic|||||30.932|4.163|<0.001
71914519|NCT02963766|143350552|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.689|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||||0.5|-0.7|0.689
71914520|NCT02963766|143350552|SUPERIORITY||LS Mean difference (Final Values)|0.0||||0.924|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||||0.5|-0.6|0.924
71871128|NCT02483585|143259623|SUPERIORITY||Odds Ratio (OR)|1.33||||0.13|TWO_SIDED|95.0|0.92|1.9|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).||1.90|0.92|0.13
71914521|NCT02963766|143350552|SUPERIORITY||LS Mean difference (Final Values)|-0.1||||0.776|TWO_SIDED|95.0|-0.6|0.4|||Mixed Models Analysis|||||0.4|-0.6|0.776
71914522|NCT00499460|143350564|SUPERIORITY|The primary hypothesis being tested is that garlic powder treatment increases metabolic clearance of oxycodone through enzyme induction and results in lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is oxycodone oral clearance. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
71914523|NCT00499460|143350565|SUPERIORITY|The secondary hypothesis being tested is that powder garlic treatment lowers Cold Pressor Test tolerance (i.e., diminished analgesic response) after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is log Tolerance AUC. Explanatory variables include treatment, period and gender, along with their interaction terms.||||||>0.05
71914524|NCT00499460|143350566|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total SSE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
71914525|NCT00499460|143350567|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total CASE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.||||||>0.05
71914526|NCT00499460|143350568|SUPERIORITY||||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||The secondary hypothesis being tested is that garlic powder induces CYP3A-mediated metabolism resulting in a lower oral midazolam AUC.||||>0.05
71914527|NCT00499460|143350569|SUPERIORITY|The secondary hypothesis being tested is that garlic powder treatment induces intestinal P-glycoprotein, reduces the bioavailability and hence AUC of orally administered digoxin.|||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||||||>0.05
71871129|NCT00912301|143259630|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Dunnett's test|pairwise comparison low dose NaCDC against placebo||||||0.031
71871130|NCT00912301|143259630|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Dunnett's test|pairwise comparison high dose NaCDC against placebo||||||0.010
71871131|NCT00819390|143259716|SUPERIORITY_OR_OTHER|||||||0.428||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.428
71914528|NCT00814307|143350570|SUPERIORITY_OR_OTHER||Percent difference|39.04|||<|0.0001|TWO_SIDED|95.0|29.12|48.95||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||48.95|29.12|<0.0001
71914529|NCT00814307|143350570|SUPERIORITY_OR_OTHER||Percent difference|33.08|||<|0.0001|TWO_SIDED|95.0|23.04|43.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.||43.13|23.04|<0.0001
71914530|NCT00814307|143350571|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.38|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.27||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.27|-0.50|<.0001
71914531|NCT00814307|143350571|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.2||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.||-0.20|-0.43|<0.0001
71914532|NCT00814307|143350572|SUPERIORITY_OR_OTHER||Percent difference|5.24||||0.0728|TWO_SIDED|95.0|-0.49|10.96||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||10.96|-0.49|0.0728
71914533|NCT00814307|143350572|SUPERIORITY_OR_OTHER||Percent difference|1.31||||0.6193|TWO_SIDED|95.0|-3.85|6.46||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.||6.46|-3.85|0.6193
71914534|NCT01256918|143350616|SUPERIORITY_OR_OTHER||incidence|0.0|||>|0.05|||||||incidence|||"Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture."||||>0.05
71914535|NCT01256918|143350617|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.850958|||<|0.05|||||||pearson correlation coefficient|||null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chop||||<0.05
71914536|NCT01256918|143350618|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.842617|||<|0.05|||||||pearson correlation coefficient|||"Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip."||||<0.05
71914537|NCT01256918|143350619|SUPERIORITY_OR_OTHER||pearson correlation coefficient|0.111166|||>|0.05|||||||pearson correlation coefficient|||null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsification||||>0.05
71914538|NCT01594749|143350631|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
71914539|NCT01594749|143350632|SUPERIORITY_OR_OTHER||Difference in percentage vs. Control|0.6||||0.085|TWO_SIDED|95.0|-0.2|1.7||P-value based on Miettinen \& Nurminen method|Miettinen & Nurminen method|||||1.7|-0.2|0.085
71914540|NCT01594749|143350634|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
71914541|NCT01594749|143350635|SUPERIORITY_OR_OTHER|||||||0.184||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||0.184
71914542|NCT01594749|143350636|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen||||<0.001
71914543|NCT02177786|143350637|SUPERIORITY||Least Square Means Difference|0.38|STANDARD_ERROR_OF_MEAN|1.21||0.755|TWO_SIDED|95.0|-2.0|2.75||Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||2.75|-2.00|0.755
71914544|NCT02177786|143350637|SUPERIORITY||Least Square Means Difference|0.84|STANDARD_ERROR_OF_MEAN|1.22||0.492|TWO_SIDED|95.0|-1.55|3.23||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||3.23|-1.55|0.492
71914545|NCT02177786|143350637|SUPERIORITY||Least Square Means Difference|-0.87|STANDARD_ERROR_OF_MEAN|1.23||0.481|TWO_SIDED|95.0|-3.29|1.56||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM|||||1.56|-3.29|0.481
71914546|NCT02177786|143350638|SUPERIORITY||Difference in Percentages|-2.2||||0.798|TWO_SIDED|95.0|-16.1|11.7|||Cochran-Mantel-Haenszel|P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||11.7|-16.1|0.798
71914547|NCT02177786|143350638|SUPERIORITY||Difference in Percentages|-9.2||||0.175|TWO_SIDED|95.0|-22.3|4.0|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||4.0|-22.3|0.175
71914548|NCT02177786|143350638|SUPERIORITY||Difference in Percentages|-2.9||||0.686|TWO_SIDED|95.0|-16.6|10.9|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.|||10.9|-16.6|0.686
71914549|NCT00439309|143350639|NON_INFERIORITY_OR_EQUIVALENCE|The sealing success rates for the investigational group and control groups were assumed to be 0.85 (85%) and 0.75 (75%), respectively, and the non-inferiority margin (10%) is 0.10. For safety reasons it was desired to have at least 100 Vascular Sealant treated subjects. It was determined that a sample size of at least 31 evaluable subjects is required for the control group. For blocking purposes, the number of evaluable control group subjects was set to 33, for a 3:1 randomization.||||||0.072|||||||Z-Test|one-sided Z-test based on the normal approximation to the binomial distribution testing||The effectiveness analyses were performed on the ITT population.||||0.072
71914550|NCT00439309|143350640|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAM Treatment from two-sided test based on the GEE regression model.||||||0.006
71914551|NCT00439309|143350641|SUPERIORITY_OR_OTHER|||||||0.654|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAMTreatment from two-sided test based on the GEE regression model||||||0.654
71914552|NCT00439309|143350642|SUPERIORITY_OR_OTHER|||||||0.089|||||||t-test, 2 sided|||||||0.089
71914553|NCT00439309|143350643|SUPERIORITY_OR_OTHER|||||||0.404|||||||Log Rank|Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group||||||0.404
71914554|NCT01951326|143350731|SUPERIORITY|||||||0.0048|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0048
71914555|NCT01951326|143350732|SUPERIORITY|||||||0.0116|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0116
71914556|NCT01951326|143350733|SUPERIORITY|||||||0.0616|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0616
71914557|NCT01951326|143350734|SUPERIORITY|||||||0.0851|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0851
71914558|NCT01951326|143350735|SUPERIORITY|||||||0.0147|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0147
71914559|NCT01951326|143350736|SUPERIORITY|||||||0.151|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.1510
71914560|NCT01951326|143350737|SUPERIORITY|||||||0.2402|||||||Log Rank|||||||0.2402
71914561|NCT01951326|143350738|SUPERIORITY|||||||0.046|||||||Log Rank|||||||0.0460
71914562|NCT01951326|143350739|SUPERIORITY|||||||0.0031|||||||Log Rank|||||||0.0031
71914563|NCT01951326|143350740|SUPERIORITY|||||||0.01|||||||Log Rank|||||||0.0100
71914564|NCT01951326|143350741|SUPERIORITY|||||||0.0077|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0077
71914565|NCT01951326|143350742|SUPERIORITY|||||||0.0422|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).||||||0.0422
71914566|NCT01726504|143350758|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis|||During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P\<0.001) times more than that in the SA group.||||<0.001
71914567|NCT00617162|143350775|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.3989|TWO_SIDED|95.0|-5.5|2.2|||Fisher Exact|||||2.2|-5.5|0.3989
71914568|NCT00735072|143350784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.||||0.014
71914569|NCT00735072|143350785|OTHER|||||||0.97|||||||Mixed Models Analysis|||||||0.97
71914570|NCT00735072|143350786|OTHER|||||||0.33|||||||Mixed Models Analysis|||||||0.33
71914571|NCT03241589|143350843|SUPERIORITY||Odds Ratio (OR)|0.931||||0.7428|TWO_SIDED|95.0|0.606|1.429|||Regression, Logistic||Referent group is Urban|We followed power calculations described in uploaded protocol document, using an incomplete design matrix with a 3-month transition period, a level of precision α=0.05 and a minimum power level of 0.80. We also assumed a total number of clusters I=36 as per the study design and the number of baseline measurements B=2. Due to insufficient sample size, we modified groups studied.||1.429|0.606|0.7428
71914572|NCT03241589|143350844|SUPERIORITY||Odds Ratio (OR)|2.258||||0.0031|TWO_SIDED|95.0|1.181|4.315|||Regression, Logistic|2 degrees of freedom, Wald Chi-Square 11.5759|Veterans with expired requests = referent.|||4.315|1.181|0.0031
71914573|NCT02972593|143350846|OTHER|Data collapsed to participant level, creating an ever/never response for each participant for each infection outcome type. Analyses performed at the participant level to determine if proportion of outcome types were similar between transfusion groups using Fisher's Exact tests, due to small expected cell counts, using SAS v9.4 (SAS Institute, Cary, NC). Power analyses performed based on these proportions using bootstrapping methods in SAS and confirmed with nQuery v8.7.1.0.||||||0.0122|||||||Fisher Exact|||||||.0122
71914574|NCT02972593|143350847|OTHER|||||||0.7742|||||||Fisher Exact|||||||.7742
71914575|NCT02972593|143350848|OTHER|||||||0.1443|||||||t-test, 1 sided|||||||.1443
71914576|NCT04599972|143350849|SUPERIORITY||Odds Ratio (OR)|2.979|||<|0.01|TWO_SIDED|95.0|1.753|5.064|||Regression, Logistic|||All treatment comparisons for primary and secondary endpoints related to BDCVA were conducted with a logistic regression model including fixed effects of baseline BDCVA at 40 cm as a covariate and treatment.||5.064|1.753|<0.01
71914577|NCT04599972|143350850|SUPERIORITY||Odds Ratio (OR)|2.807|||<|0.01|TWO_SIDED|95.0|1.655|4.762|||Regression, Logistic|||||4.762|1.655|<0.01
71914578|NCT04599972|143350851|SUPERIORITY||Odds Ratio (OR)|6.002|||<|0.01|TWO_SIDED|95.0|3.431|10.499|||Regression, Logistic|||||10.499|3.431|<0.01
71914579|NCT04599972|143350852|SUPERIORITY||Odds Ratio (OR)|4.161|||<|0.01|TWO_SIDED|95.0|2.404|7.204|||Regression, Logistic|||||7.204|2.404|<0.01
71914580|NCT00565812|143350910|SUPERIORITY_OR_OTHER||Difference in Slopes|0.012|STANDARD_ERROR_OF_MEAN|0.018||0.50877|TWO_SIDED|95.0|-0.023|0.046|||Mixed Models Analysis|||Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group\*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG\*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.||0.046|-0.023|0.508770
71914581|NCT00565812|143350910|SUPERIORITY_OR_OTHER||Difference in Slopes|0.005|STANDARD_ERROR_OF_MEAN|0.017||0.754074|TWO_SIDED|95.0|-0.029|0.04|||Mixed Models Analysis|||Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group\*time interaction, (collapsed) KLG, KLG\*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.||0.040|-0.029|0.754074
71914582|NCT00565812|143350911|SUPERIORITY_OR_OTHER||Difference in slopes|0.023|STANDARD_ERROR_OF_MEAN|0.023||0.312|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.312
71914583|NCT00565812|143350911|SUPERIORITY_OR_OTHER||Difference in slopes|0.022|STANDARD_ERROR_OF_MEAN|0.023||0.327|TWO_SIDED|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.067|-0.022|0.327
71914584|NCT00565812|143350912|SUPERIORITY_OR_OTHER||Difference in slopes|0.004|STANDARD_ERROR_OF_MEAN|0.026||0.881|TWO_SIDED|95.0|-0.046|0.054|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.054|-0.046|0.881
71914585|NCT00565812|143350912|SUPERIORITY_OR_OTHER||Difference in slopes|-0.007|STANDARD_ERROR_OF_MEAN|0.025||0.78|TWO_SIDED|95.0|-0.056|0.042|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.||0.042|-0.056|0.780
71914586|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.84||0.639|TWO_SIDED|95.0|-1.26|2.05|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.05|-1.26|0.639
71914587|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.84||0.957|TWO_SIDED|95.0|-1.61|1.7|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.70|-1.61|0.957
71914588|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|0.96||0.893|TWO_SIDED|95.0|-1.76|2.01|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-1.76|0.893
71914589|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.96||0.365|TWO_SIDED|95.0|-1.01|2.76|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.76|-1.01|0.365
71914590|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|1.05||0.678|TWO_SIDED|95.0|-1.63|2.51|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.51|-1.63|0.678
71914591|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|1.05||0.902|TWO_SIDED|95.0|-2.18|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-2.18|0.902
71914592|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|1.15||0.577|TWO_SIDED|95.0|-2.89|1.61|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-2.89|0.577
71914593|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.14||0.98|TWO_SIDED|95.0|-2.26|2.21|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-2.26|0.980
71914594|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|1.17||0.95|TWO_SIDED|95.0|-2.37|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-2.37|0.950
71914595|NCT00565812|143350913|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|STANDARD_ERROR_OF_MEAN|1.17||0.292|TWO_SIDED|95.0|-3.53|1.06|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.06|-3.53|0.292
71914596|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.683|TWO_SIDED|95.0|-0.3|0.46|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-0.30|0.683
71914597|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.19||0.853|TWO_SIDED|95.0|-0.42|0.35|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.42|0.853
71914598|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.22||0.938|TWO_SIDED|95.0|-0.41|0.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.41|0.938
71914599|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.648|TWO_SIDED|95.0|-0.32|0.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-0.32|0.648
71914600|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.916|TWO_SIDED|95.0|-0.49|0.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.44|-0.49|0.916
71914601|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.528|TWO_SIDED|95.0|-0.6|0.31|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.31|-0.60|0.528
71914602|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.25||0.365|TWO_SIDED|95.0|-0.73|0.27|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.73|0.365
71914603|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.328|TWO_SIDED|95.0|-0.74|0.25|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.25|-0.74|0.328
71914604|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.26||0.54|TWO_SIDED|95.0|-0.66|0.35|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.35|-0.66|0.540
71871132|NCT00819390|143259716|SUPERIORITY_OR_OTHER|||||||0.247||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments.||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.||||0.247
71871133|NCT01270971|143259746|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71871134|NCT01270971|143259747|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71871135|NCT01270971|143259748|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71914605|NCT00565812|143350914|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.26||0.423|TWO_SIDED|95.0|-0.71|0.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.30|-0.71|0.423
71914606|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.904|TWO_SIDED|95.0|-0.17|0.2|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.17|0.904
71914607|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.09||0.582|TWO_SIDED|95.0|-0.24|0.13|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.24|0.582
71914608|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.1||0.818|TWO_SIDED|95.0|-0.22|0.18|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-0.22|0.818
71914609|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.988|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.20|-0.20|0.988
71914610|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.11||0.857|TWO_SIDED|95.0|-0.2|0.24|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.20|0.857
71914611|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.11||0.658|TWO_SIDED|95.0|-0.17|0.27|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.27|-0.17|0.658
71914612|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.12||0.612|TWO_SIDED|95.0|-0.28|0.17|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.17|-0.28|0.612
71914613|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.391|TWO_SIDED|95.0|-0.32|0.13|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.13|-0.32|0.391
71914614|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||1|TWO_SIDED|95.0|-0.24|0.24|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.24|-0.24|1.000
71683192|NCT05079230|142884471|SUPERIORITY||Stratified Odds Ratio|1.21||||0.579|TWO_SIDED|95.0|0.62|2.36||The 2-sided P-value was based on Cochran-Mantel-Haenszel (CMH) method stratified by the stratification factors at randomization (age, genetic risk group, and geographic region).|Cochran-Mantel-Haenszel|||||2.360|0.620|0.5790
71871136|NCT01270971|143259749|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71871137|NCT01242800|143259755|SUPERIORITY|||||||0.32|||||||Log Rank|Stratified log rank test was used for arm comparison||||||0.32
71871138|NCT02640157|143259760|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|95.0|-5.6|3.1||||||Difference in SVR12 rates (Arm A - Arm B).||3.1|-5.6|
71683193|NCT05079230|142884472|SUPERIORITY||Stratified Hazard Ratio|1.09||||0.5796|TWO_SIDED|95.0|0.799|1.487|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI are calculated using the stratified cox proportional hazards model.|||1.487|0.799|0.5796
71871139|NCT02640157|143259760|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|percentage of participants|95.3|||||TWO_SIDED|97.5|92.2|98.4||||||||98.4|92.2|
71871140|NCT02640157|143259760|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||TWO_SIDED|97.5|-6.2|3.7||||||Difference in SVR12 rates (Arm A - Arm B).||3.7|-6.2|
71914615|NCT00565812|143350915|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.086|TWO_SIDED|95.0|-0.45|0.03|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.03|-0.45|0.086
71914616|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.62||0.586|TWO_SIDED|95.0|-0.88|1.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.55|-0.88|0.586
71914617|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.789|TWO_SIDED|95.0|-1.05|1.38|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-1.05|0.789
71914618|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.16|STANDARD_ERROR_OF_MEAN|0.69||0.821|TWO_SIDED|95.0|-1.21|1.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.52|-1.21|0.821
71914619|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.69||0.294|TWO_SIDED|95.0|-0.63|2.09|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|-0.63|0.294
71914620|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.48|STANDARD_ERROR_OF_MEAN|0.76||0.532|TWO_SIDED|95.0|-1.02|1.97|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-1.02|0.532
71914621|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.76||0.938|TWO_SIDED|95.0|-1.55|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.55|0.938
71914622|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.83||0.68|TWO_SIDED|95.0|-1.97|1.29|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.29|-1.97|0.680
71914623|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.82||0.73|TWO_SIDED|95.0|-1.33|1.9|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.90|-1.33|0.730
71914624|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.84||0.901|TWO_SIDED|95.0|-1.55|1.76|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.55|0.901
71871141|NCT02640157|143259761|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|95.0|-4.8|4.0||||||Difference in SVR12 rates (Arm C - Arm A)||4.0|-4.8|
71871142|NCT02640157|143259761|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Percentage of participants|94.9|||||TWO_SIDED|97.5|91.0|98.8||||||||98.8|91.0|
71914625|NCT00565812|143350916|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.84||0.333|TWO_SIDED|95.0|-2.45|0.83|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-2.45|0.333
71914626|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|2.34|STANDARD_ERROR_OF_MEAN|1.36||0.086|TWO_SIDED|95.0|-0.33|5.01|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||5.01|-0.33|0.086
71914627|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|1.36||0.415|TWO_SIDED|95.0|-1.56|3.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.78|-1.56|0.415
71914628|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.41||0.569|TWO_SIDED|95.0|-1.97|3.57|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.57|-1.97|0.569
71914629|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|1.26|STANDARD_ERROR_OF_MEAN|1.41||0.374|TWO_SIDED|95.0|-1.51|4.02|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.02|-1.51|0.374
71914630|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|1.63|STANDARD_ERROR_OF_MEAN|1.53||0.288|TWO_SIDED|95.0|-1.38|4.64|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.64|-1.38|0.288
71914631|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.52||0.44|TWO_SIDED|95.0|-1.81|4.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.17|-1.81|0.440
71914632|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|1.58||0.896|TWO_SIDED|95.0|-3.3|2.88|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.30|0.896
71914633|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.56||0.464|TWO_SIDED|95.0|-1.92|4.2|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.20|-1.92|0.464
71914634|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|1.57||0.901|TWO_SIDED|95.0|-3.27|2.88|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-3.27|0.901
71914635|NCT00565812|143350917|SUPERIORITY_OR_OTHER||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.56||0.8|TWO_SIDED|95.0|-3.45|2.66|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.66|-3.45|0.800
71914636|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.048||0.984|TWO_SIDED|95.0|-0.093|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.093|0.984
71914637|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.046|STANDARD_ERROR_OF_MEAN|0.048||0.33|TWO_SIDED|95.0|-0.14|0.047|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.047|-0.140|0.330
71683194|NCT05079230|142884473|SUPERIORITY||Stratified Hazard Ratio|1.271||||0.1026|TWO_SIDED|95.0|0.948|1.704|||Stratified Log Rank|The 2-sided P-value was based on stratified log-rank test, stratified by stratification factors at randomization.|Stratified hazard ratio (HR) and its 95% CI were calculated using the stratified cox proportional hazards model.|||1.704|0.948|0.1026
71871143|NCT02640157|143259761|NON_INFERIORITY|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was \>92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was \>92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||TWO_SIDED|97.5|-5.4|4.6||||||||4.6|-5.4|
71871144|NCT04677179|143259774|SUPERIORITY||Odds Ratio (OR)|0.57||||0.75|TWO_SIDED|95.0|0.03|11.32|||Cochran-Mantel-Haenszel|||||11.32|0.03|0.750
71871145|NCT04677179|143259774|SUPERIORITY||Odds Ratio (OR)|0.8||||0.838|TWO_SIDED|95.0|0.1|6.21|||Cochran-Mantel-Haenszel|||||6.21|0.10|0.838
71871146|NCT04677179|143259775|SUPERIORITY||Odds Ratio (OR)|0.57||||0.563|TWO_SIDED|95.0|0.1|3.3|||Cochran-Mantel-Haenszel|||||3.30|0.10|0.563
71871147|NCT04677179|143259775|SUPERIORITY||Odds Ratio (OR)|0.78||||0.759|TWO_SIDED|95.0|0.17|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.17|0.759
71871148|NCT04677179|143259776|SUPERIORITY||Odds Ratio (OR)|0.18||||0.163|TWO_SIDED|95.0|0.02|1.93|||Cochran-Mantel-Haenszel|||||1.93|0.02|0.163
71871149|NCT04677179|143259776|SUPERIORITY||Odds Ratio (OR)|0.54||||0.439|TWO_SIDED|95.0|0.11|2.77|||Cochran-Mantel-Haenszel|||||2.77|0.11|0.439
71871150|NCT04677179|143259777|SUPERIORITY||Odds Ratio (OR)|1.29||||0.821|TWO_SIDED|95.0|0.17|9.88|||Cochran-Mantel-Haenszel|||||9.88|0.17|0.821
71871151|NCT04677179|143259777|SUPERIORITY||Odds Ratio (OR)|1.43||||0.572|TWO_SIDED|95.0|0.37|5.49|||Cochran-Mantel-Haenszel|||||5.49|0.37|0.572
71871152|NCT04677179|143259778|SUPERIORITY||Odds Ratio (OR)|1.18||||0.886|TWO_SIDED|95.0|0.14|10.16|||Cochran-Mantel-Haenszel|||||10.16|0.14|0.886
71871153|NCT04677179|143259778|SUPERIORITY||Odds Ratio (OR)|0.78||||0.784|TWO_SIDED|95.0|0.14|4.18|||Cochran-Mantel-Haenszel|||||4.18|0.14|0.784
71871154|NCT04677179|143259779|SUPERIORITY||Odds Ratio (OR)|0.37||||0.331|TWO_SIDED|95.0|0.06|2.43|||Cochran-Mantel-Haenszel|||||2.43|0.06|0.331
71871155|NCT04677179|143259779|SUPERIORITY||Odds Ratio (OR)|0.51||||0.407|TWO_SIDED|95.0|0.1|2.52|||Cochran-Mantel-Haenszel|||||2.52|0.10|0.407
71871156|NCT04677179|143259780|SUPERIORITY||Risk Ratio (RR)|1.5||||0.564|TWO_SIDED|95.0|0.38|6.0|||Cochran-Mantel-Haenszel|||||6.00|0.38|0.564
71871157|NCT04677179|143259780|SUPERIORITY||Risk Ratio (RR)|1.51||||0.681|TWO_SIDED|95.0|0.21|10.97|||Cochran-Mantel-Haenszel|||||10.97|0.21|0.681
71871158|NCT04677179|143259781|SUPERIORITY||Risk Difference (RD)|3.6||||0.317|TWO_SIDED|95.0|-3.3|10.4|||Cochran-Mantel-Haenszel|||||10.4|-3.3|0.317
71871159|NCT04677179|143259781|SUPERIORITY||Risk Difference (RD)|6.9||||0.238|TWO_SIDED|95.0|-2.3|16.1|||Cochran-Mantel-Haenszel|||||16.1|-2.3|0.238
71871160|NCT04677179|143259782|SUPERIORITY||LS Mean Difference|9.71|STANDARD_ERROR_OF_MEAN|10.935||0.378|TWO_SIDED|95.0|-12.17|31.6|||ANCOVA|||||31.60|-12.17|0.378
71871161|NCT04677179|143259782|SUPERIORITY||LS Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|10.406||0.928|TWO_SIDED|95.0|-21.78|19.88|||ANCOVA|||||19.88|-21.78|0.928
71871162|NCT02641496|143259804|OTHER|ANOVA||||||0.027||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Treatment 1 to Treatment 4 (approximately first 30 days of treatment)||||0.027
71871163|NCT02641496|143259804|OTHER|ANOVA||||||0.919||||||Significance threshold p\<0.05; one-tailed|ANOVA|||Last 30 Days of 1 Year Study||||0.919
71871164|NCT02641496|143259805|OTHER|||||||0.696||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.696
71871165|NCT02641496|143259806|OTHER|||||||0.593||||||Significance threshold p\<0.05; two-tailed|ANOVA|||||||0.593
71871166|NCT02641496|143259807|OTHER|||||||0.925||||||Significance threshold p\<0.05; one-tailed|ANOVA|||||||0.925
71871167|NCT00600886|143259811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.942||||0.007|TWO_SIDED|95.0|1.19|3.168|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel adjusting for randomization stratification factor||Overall - All patients||3.168|1.190|0.007
71871168|NCT00600886|143259811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.337|||||TWO_SIDED|95.0|1.14|4.79||||||Post surgery - patients with prior surgery but no previous medical treatment for acromegaly||4.790|1.140|
71871169|NCT00600886|143259811|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.654|||||TWO_SIDED|95.0|0.846|3.234||||||De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.||3.234|0.846|
71683195|NCT01524783|142884479|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.35|0.67|||Log Rank|||||0.67|0.35|<0.001
71683196|NCT01524783|142884480|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.9||||0.259|TWO_SIDED|95.0|0.66|1.24|||Log Rank|||||1.24|0.66|0.259
71871170|NCT03075410|143259867|OTHER||Ratio|1.07|||||TWO_SIDED|90.0|0.87|1.34|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.34|0.87|
71871171|NCT03075410|143259868|OTHER||Ratio|0.94|||||TWO_SIDED|90.0|0.71|1.26|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-inf). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is use|||1.26|0.71|
71871172|NCT03075410|143259869|OTHER||Ratio|0.97|||||TWO_SIDED|90.0|0.76|1.23|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.|||1.23|0.76|
71871173|NCT03075410|143259870|OTHER||Ratio|0.89|||||TWO_SIDED|90.0|0.64|1.23|||||Fixed Effect Model has been used to assess Food Effect for the log transformed parameter t1/2 Treatment in the fed/fasted state is fitted as Fixed Effect.|||1.23|0.64|
71871174|NCT03075410|143259871|OTHER||Median Difference (Final Values)|0.75|||||TWO_SIDED|90.0|-0.5|2.5|||||Hodges-Lehmann estimation is used to calculate the 90% confidence interval.|||2.50|-0.50|
71871175|NCT03075410|143259875|OTHER||Slope|1.1|||||TWO_SIDED|90.0|1.09|1.1|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 5mg Day 1-14||1.10|1.09|
71871176|NCT03075410|143259875|OTHER||Slope|1.08|||||TWO_SIDED|90.0|1.07|1.08|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 15mg Day 1-14||1.08|1.07|
71871177|NCT03075410|143259876|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.82|1.1|||||A slope of 1 indicates the pharmacokinetics are dose proportional. A slope greater than 1 indicates the increase in PK is greater than proportional to dose.||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|1.10|0.82|
71871178|NCT03075410|143259877|OTHER||Slope|1.32|||||TWO_SIDED|90.0|1.24|1.39|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.39|1.24|
71871179|NCT03075410|143259878|OTHER||Slope|0.96|||||TWO_SIDED|90.0|0.81|1.11|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.|||1.11|0.81|
71871180|NCT03075410|143259879|OTHER||Slope|1.24|||||TWO_SIDED|90.0|1.15|1.33|||||Day 1.Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.33|1.15|
71683197|NCT01524783|142884483|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.073|TWO_SIDED|95.0|0.5|1.1|||Log Rank|||||1.10|0.50|0.073
71871181|NCT03075410|143259879|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.9|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.90|
71871182|NCT03075410|143259880|OTHER||Slope|1.19|||||TWO_SIDED|90.0|0.92|1.46|||||Day 1. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.46|0.92|
71871183|NCT03075410|143259880|OTHER||Slope|1.06|||||TWO_SIDED|90.0|0.89|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.|||1.22|0.89|
71871184|NCT03319849|143259901|SUPERIORITY||Median Difference (Final Values)|-0.049|STANDARD_ERROR_OF_MEAN|0.0206||0.0186|TWO_SIDED|95.0|-0.089|-0.0082|||Mixed Models Analysis|||||-0.0082|-0.0890|0.0186
71871185|NCT03938545|143259921|SUPERIORITY||Risk Difference (RD)|21.4|||=|0.1993|TWO_SIDED|95.0|-11.3|54.1||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 680 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||54.1|-11.3|=0.1993
71871186|NCT03938545|143259921|SUPERIORITY||Risk Difference (RD)|24.2|||=|0.1016|TWO_SIDED|95.0|-4.8|53.2||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 340 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||53.2|-4.8|=0.1016
71683198|NCT01524783|142884486|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.02||||0.539|TWO_SIDED|95.0|0.65|1.61|||Log Rank|||||1.61|0.65|0.539
71683199|NCT01782352|142884505|SUPERIORITY||Hazard Ratio (HR)|1.02|||<|0.05|TWO_SIDED|95.0|0.82|1.27|||Regression, Cox|||||1.27|0.82|<0.05
71871187|NCT03938545|143259921|SUPERIORITY||Risk Difference (RD)|-8.3|||=|0.2963|TWO_SIDED|95.0|-24.0|7.3||p-values were obtained from a Mantel-Haenszel test stratified by smoking status at baseline comparing RVT-1401 255 mg/Week group to placebo.|Cochran-Mantel-Haenszel||The risk difference was obtained from a weighted average of the difference within each stratum using Cochran Mantel-Haenszel weights.|||7.3|-24.0|=0.2963
71871188|NCT03938545|143259923|SUPERIORITY||Least Square Mean Difference|-60.085|||<|0.001|TWO_SIDED|95.0|-88.857|-31.313|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-31.313|-88.857|<0.001
71871189|NCT03938545|143259923|SUPERIORITY||Least Square Mean Difference|-65.143|||<|0.001|TWO_SIDED|95.0|-91.927|-38.358|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-38.358|-91.927|<0.001
71871190|NCT03938545|143259923|SUPERIORITY||Least Square Mean Difference|-37.323|||=|0.0284|TWO_SIDED|95.0|-70.455|-4.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||||-4.190|-70.455|=0.0284
71871191|NCT03938545|143259924|SUPERIORITY||Least Square Mean Difference|-73.003|||<|0.001|TWO_SIDED|95.0|-82.309|-63.697|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-63.697|-82.309|<0.001
71871192|NCT03938545|143259924|SUPERIORITY||Least Square Mean Difference|-59.005|||<|0.001|TWO_SIDED|95.0|-67.821|-50.19|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-50.190|-67.821|<0.001
71914638|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.049||0.308|TWO_SIDED|95.0|-0.146|0.046|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.046|-0.146|0.308
71914639|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.049||0.089|TWO_SIDED|95.0|-0.18|0.013|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.013|-0.180|0.089
71914640|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.035|STANDARD_ERROR_OF_MEAN|0.052||0.508|TWO_SIDED|95.0|-0.137|0.068|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.068|-0.137|0.508
71914641|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.036|STANDARD_ERROR_OF_MEAN|0.052||0.49|TWO_SIDED|95.0|-0.137|0.066|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.066|-0.137|0.490
71914642|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.057||0.739|TWO_SIDED|95.0|-0.132|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.132|0.739
71914643|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.057||0.376|TWO_SIDED|95.0|-0.162|0.061|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.061|-0.162|0.376
71914644|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.057||0.883|TWO_SIDED|95.0|-0.121|0.104|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.104|-0.121|0.883
71914645|NCT00565812|143350918|SUPERIORITY_OR_OTHER||LS mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.057||0.69|TWO_SIDED|95.0|-0.135|0.089|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.089|-0.135|0.690
71914646|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.044||0.849|TWO_SIDED|95.0|-0.078|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.095|-0.078|0.849
71914647|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.044||0.837|TWO_SIDED|95.0|-0.096|0.078|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.096|0.837
71871193|NCT03938545|143259924|SUPERIORITY||Least Square Mean Difference|-51.836|||<|0.001|TWO_SIDED|95.0|-62.66|-41.012|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||Week 13||-41.012|-62.660|<0.001
71871194|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-81.49|||<|0.001|TWO_SIDED|95.0|-93.203|-69.777|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-69.777|-93.203|<0.001
71871195|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-67.591|||<|0.001|TWO_SIDED|95.0|-78.562|-56.62|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-56.620|-78.562|<0.001
71871196|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-67.233|||<|0.001|TWO_SIDED|95.0|-81.073|-53.394|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG1||-53.394|-81.073|<0.001
71871197|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-74.865|||<|0.001|TWO_SIDED|95.0|-86.898|-62.832|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-62.832|-86.898|<0.001
71871198|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-53.198|||<|0.001|TWO_SIDED|95.0|-64.799|-41.596|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-41.596|-64.799|<0.001
71871199|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-53.398|||<|0.001|TWO_SIDED|95.0|-67.552|-39.245|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG2||-39.245|-67.552|<0.001
71871200|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-88.764|||<|0.001|TWO_SIDED|95.0|-103.039|-74.489|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-74.489|-103.039|<0.001
71871201|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-65.714|||<|0.001|TWO_SIDED|95.0|-78.742|-52.686|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-52.686|-78.742|<0.001
71871202|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-66.685|||<|0.001|TWO_SIDED|95.0|-83.157|-50.214|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG3||-50.214|-83.157|<0.001
71871203|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-68.722|||<|0.001|TWO_SIDED|95.0|-80.877|-56.568|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-56.568|-80.877|<0.001
71871204|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-55.554|||<|0.001|TWO_SIDED|95.0|-67.182|-43.926|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-43.926|-67.182|<0.001
71914648|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.047||0.776|TWO_SIDED|95.0|-0.105|0.078|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.078|-0.105|0.776
71914649|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.047||0.033|TWO_SIDED|95.0|-0.191|-0.008|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.008|-0.191|0.033
71914650|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.064|STANDARD_ERROR_OF_MEAN|0.05||0.201|TWO_SIDED|95.0|-0.163|0.034|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.034|-0.163|0.201
71914651|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.103|STANDARD_ERROR_OF_MEAN|0.05||0.038|TWO_SIDED|95.0|-0.201|-0.006|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.006|-0.201|0.038
71914652|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.053||0.848|TWO_SIDED|95.0|-0.114|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.094|-0.114|0.848
71914653|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|-0.019|STANDARD_ERROR_OF_MEAN|0.052||0.714|TWO_SIDED|95.0|-0.122|0.084|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.084|-0.122|0.714
71914654|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|0.025|STANDARD_ERROR_OF_MEAN|0.054||0.652|TWO_SIDED|95.0|-0.082|0.131|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.131|-0.082|0.652
71914655|NCT00565812|143350919|SUPERIORITY_OR_OTHER||LS mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.054||0.7|TWO_SIDED|95.0|-0.085|0.127|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.127|-0.085|0.700
71914656|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|1.68|STANDARD_ERROR_OF_MEAN|1.37||0.22|TWO_SIDED|95.0|-1.0|4.36|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.36|-1.00|0.220
71871205|NCT03938545|143259925|SUPERIORITY||Least Square Mean Difference|-53.079|||<|0.001|TWO_SIDED|95.0|-67.948|-38.21|||ANCOVA|The model included baseline value of the corresponding parameter, smoking stratum, and treatment group as covariates.||IgG4||-38.210|-67.948|<0.001
71871206|NCT01060540|143259926|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.44|TWO_SIDED|95.0|-0.3|0.7|||Mixed Models Analysis|Adjusted for family history (low/unknown vs. high/moderate) and BMI\>=35 (yes vs no) stratification variables||||0.7|-0.3|0.44
71871207|NCT01060540|143259927|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.19|TWO_SIDED|95.0|-0.1|0.3||adjusted for baseline BMI class and family history level stratification variables|Mixed Models Analysis|||||0.3|-0.1|0.19
71871208|NCT01060540|143259928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.38|TWO_SIDED|95.0|-0.4|0.1||adjusted for stratification variables baseline BMI and family history|Mixed Models Analysis|||||0.1|-0.4|0.38
71871209|NCT01060540|143259929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.05|TWO_SIDED|95.0|-0.2|0.0||adjusted for baseline family history and BMI|Mixed Models Analysis|||||0.0|-0.2|0.05
71871210|NCT01060540|143259930|SUPERIORITY_OR_OTHER||incident rate ratio|0.9||||0.68|TWO_SIDED|95.0|0.7|1.2||adjusted for baseline family history and BMI|generalized linear model for count data|||||1.2|0.7|0.68
71871211|NCT02502097|143259935|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.5096|TWO_SIDED|95.0|-10.1|5.1|||Mixed Models Analysis||LS mean difference Day 7|||5.1|-10.1|0.5096
71871212|NCT02502097|143259935|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-0.8||||0.8983|TWO_SIDED|95.0|-13.4|11.8|||Mixed Models Analysis||LS mean difference Day 14|||11.8|-13.4|0.8983
71871213|NCT02502097|143259939|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.7||||0.5005|TWO_SIDED|95.0|-14.6|7.2|||Mixed Models Analysis||LS means difference Day 7|||7.2|-14.6|0.5005
71871214|NCT02502097|143259939|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.8||||0.8382|TWO_SIDED|95.0|-19.8|16.1|||Mixed Models Analysis||LS means difference Day 14|||16.1|-19.8|0.8382
71871215|NCT02502097|143259940|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.3||||0.8008|TWO_SIDED|95.0|-11.9|9.2|||Mixed Models Analysis||LS means difference Day 7|||9.2|-11.9|0.8008
71914657|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.36||0.997|TWO_SIDED|95.0|-2.67|2.68|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.68|-2.67|0.997
71914658|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|1.44||0.613|TWO_SIDED|95.0|-2.09|3.55|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.55|-2.09|0.613
71914659|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|1.44||0.964|TWO_SIDED|95.0|-2.75|2.88|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.88|-2.75|0.964
71871216|NCT02502097|143259940|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.2||||0.9805|TWO_SIDED|95.0|-17.6|18.0|||Mixed Models Analysis||LS means difference Day 14|||18.0|-17.6|0.9805
71871217|NCT02502097|143259943|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.4||||0.3279|TWO_SIDED|95.0|-7.1|2.4|||Mixed Models Analysis||LS means difference Day 7|||2.4|-7.1|0.3279
71871218|NCT02502097|143259943|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.5||||0.7772|TWO_SIDED|95.0|-9.2|12.3|||Mixed Models Analysis||LS means difference Day 14|||12.3|-9.2|0.7772
71871219|NCT02502097|143259944|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-3.2||||0.3493|TWO_SIDED|95.0|-10.1|3.6|||Mixed Models Analysis||LS means difference Day 7|||3.6|-10.1|0.3493
71683200|NCT01782352|142884505|SUPERIORITY||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.76|1.17|||Regression, Cox|||||1.17|0.76|<0.05
71871220|NCT02502097|143259944|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|1.0||||0.8952|TWO_SIDED|95.0|-14.3|16.3|||Mixed Models Analysis||LS means difference Day 14|||16.3|-14.3|0.8952
71871221|NCT02502097|143259945|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.5||||0.6597|TWO_SIDED|95.0|-8.1|5.2|||Mixed Models Analysis||LS means difference Day 7|||5.2|-8.1|0.6597
71871222|NCT02502097|143259945|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.1||||0.788|TWO_SIDED|95.0|-13.1|17.2|||Mixed Models Analysis||LS means difference Day 14|||17.2|-13.1|0.7880
71871223|NCT02502097|143259949|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.5||||0.1856|TWO_SIDED|95.0|-6.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-6.3|0.1856
71871224|NCT02502097|143259949|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|2.7||||0.5658|TWO_SIDED|95.0|-6.6|12.1|||Mixed Models Analysis||LS mean difference Day 14|||12.1|-6.6|0.5658
71871225|NCT02502097|143259950|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-8.0||||0.0847|TWO_SIDED|95.0|-17.2|1.1|||Mixed Models Analysis||LS mean difference Day 7|||1.1|-17.2|0.0847
71871226|NCT02502097|143259950|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-5.8||||0.3083|TWO_SIDED|95.0|-17.0|5.4|||Mixed Models Analysis||LS mean difference Day 14|||5.4|-17.0|0.3083
71871227|NCT02502097|143259951|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.0||||0.229|TWO_SIDED|95.0|-5.3|1.3|||Mixed Models Analysis||LS mean difference Day 7|||1.3|-5.3|0.2290
71871228|NCT02502097|143259951|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|0.0||||0.9794|TWO_SIDED|95.0|-3.5|3.4|||Mixed Models Analysis||LS mean difference Day 14|||3.4|-3.5|0.9794
71871229|NCT02502097|143259952|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.0009|TWO_SIDED|95.0|-1.5|-0.4|||Mixed Models Analysis||LS mean difference Week 1|||-0.4|-1.5|0.0009
71871230|NCT02502097|143259952|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-1.0||||0.005|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis||LS mean difference Week 2|||-0.3|-1.7|0.0050
71871231|NCT02502097|143259953|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-2.8||||0.2938|TWO_SIDED|95.0|-8.2|2.5|||Mixed Models Analysis||LS mean difference Day 7|||2.5|-8.2|0.2938
71871232|NCT02502097|143259953|SUPERIORITY|MMRM model uses the change from baseline as the dependent variable and includes the period, treatment group (Gefapixant 50 mg, Placebo), visit (Day 7 and Day 14 at each Period), all interactions terms as fixed factors, and baseline as a covariate.|Mean Difference (Final Values)|-4.0||||0.1319|TWO_SIDED|95.0|-9.2|1.2|||Mixed Models Analysis||LS mean difference Day 14|||1.2|-9.2|0.1319
71871233|NCT02502097|143259954|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.2175|TWO_SIDED|95.0|-1.5|0.4|||Mixed Models Analysis||LS mean difference Day 7|||0.4|-1.5|0.2175
71871234|NCT02502097|143259954|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.5312|TWO_SIDED|95.0|-1.4|0.7|||Mixed Models Analysis||LS mean difference Day 14|||0.7|-1.4|0.5312
71871235|NCT03310268|143259982|OTHER||Difference of Least Square mean|0.19|STANDARD_ERROR_OF_MEAN|0.094||0.0476|TWO_SIDED|95.0|0.002|0.374|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.374|0.002|0.0476
71871236|NCT03310268|143259982|OTHER||Difference of Least Square mean|-0.02|STANDARD_ERROR_OF_MEAN|0.093||0.8411|TWO_SIDED|95.0|-0.202|0.164|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.164|-0.202|0.8411
71871237|NCT03310268|143259982|OTHER||Difference of Least Square mean|0.21|STANDARD_ERROR_OF_MEAN|0.094||0.0298|TWO_SIDED|95.0|0.02|0.393|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.393|0.020|0.0298
71871238|NCT03310268|143259983|OTHER||Difference of Least Square mean|-7.2|STANDARD_ERROR_OF_MEAN|4.649||0.1232|TWO_SIDED|95.0|-16.376|1.975|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||1.975|-16.376|0.1232
71871239|NCT03310268|143259983|OTHER||Difference of Least Square mean|-4.04|STANDARD_ERROR_OF_MEAN|4.588||0.3793|TWO_SIDED|95.0|-13.099|5.011|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||5.011|-13.099|0.3793
71871240|NCT03310268|143259983|OTHER||Difference of Least Square mean|-3.16|STANDARD_ERROR_OF_MEAN|4.648||0.4979|TWO_SIDED|95.0|-12.33|6.017|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||6.017|-12.330|0.4979
71871241|NCT00706433|143259996|SUPERIORITY_OR_OTHER|||||||0.768||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.7680
71871242|NCT00706433|143259997|SUPERIORITY_OR_OTHER|||||||0.7975||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7975
71871243|NCT00706433|143259998|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
71871244|NCT00706433|143259999|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments||||>0.10
71871245|NCT00706433|143260001|SUPERIORITY_OR_OTHER|||||||0.1103||95.0|||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments||||0.1103
71871246|NCT00706433|143260002|SUPERIORITY_OR_OTHER|||||||0.7228||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.||||0.7228
71914660|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|1.49||0.872|TWO_SIDED|95.0|-2.69|3.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.17|-2.69|0.872
71914661|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|1.48||0.947|TWO_SIDED|95.0|-2.81|3.01|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.01|-2.81|0.947
71871247|NCT00706433|143260003|SUPERIORITY_OR_OTHER|||||||0.3416||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates||||0.3416
71871248|NCT00706433|143260004|SUPERIORITY_OR_OTHER|||||||0.5759||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5759
71871249|NCT00706433|143260005|SUPERIORITY_OR_OTHER|||||||0.4754||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4754
71871250|NCT00706433|143260006|SUPERIORITY_OR_OTHER|||||||0.4096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4096
71871251|NCT00706433|143260007|SUPERIORITY_OR_OTHER|||||||0.5812||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5812
71871252|NCT00706433|143260008|SUPERIORITY_OR_OTHER|||||||0.8679||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8679
71871253|NCT00706433|143260009|SUPERIORITY_OR_OTHER|||||||0.3666||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3666
71871254|NCT00706433|143260010|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
71871255|NCT00706433|143260011|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871256|NCT00706433|143260012|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871257|NCT00706433|143260013|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871258|NCT00706433|143260014|SUPERIORITY_OR_OTHER|||||||0.3916||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3916
71871259|NCT00706433|143260015|SUPERIORITY_OR_OTHER|||||||0.8387||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8387
71871260|NCT00706433|143260016|SUPERIORITY_OR_OTHER|||||||0.1489||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1489
71871261|NCT00706433|143260017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
71871262|NCT00706433|143260017|SUPERIORITY_OR_OTHER|||||||0.4143||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4143
71871263|NCT00706433|143260017|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
71871264|NCT00706433|143260017|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0003
71871265|NCT00706433|143260017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
71871266|NCT00706433|143260017|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
71871267|NCT00706433|143260017|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9700
71871268|NCT00706433|143260018|SUPERIORITY_OR_OTHER|||||||0.2544||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2544
71871269|NCT00706433|143260019|SUPERIORITY_OR_OTHER|||||||0.4321||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4321
71871270|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.0317||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0317
71871271|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.5818||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5818
71871272|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.0395||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0395
71871273|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.7426||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7426
71871274|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0029
71871275|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.2142||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2142
71871276|NCT00706433|143260020|SUPERIORITY_OR_OTHER|||||||0.0781||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0781
71871277|NCT00706433|143260021|SUPERIORITY_OR_OTHER|||||||0.9886||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9886
71871278|NCT00706433|143260022|SUPERIORITY_OR_OTHER|||||||0.6907||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6907
71871279|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.0047||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0047
71871280|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.6116||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6116
71871281|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.0209||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0209
71871282|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.0513||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0513
71871283|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0019
71871284|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.0089||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0089
71871285|NCT00706433|143260023|SUPERIORITY_OR_OTHER|||||||0.526||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5260
71871286|NCT00706433|143260024|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7820
71871287|NCT00706433|143260025|SUPERIORITY_OR_OTHER|||||||0.4965||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4965
71871288|NCT00706433|143260026|SUPERIORITY_OR_OTHER|||||||0.0728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0728
71871289|NCT00706433|143260027|SUPERIORITY_OR_OTHER|||||||0.548||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5480
71871290|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.0301||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0301
71871291|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.0564||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0564
71871292|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.447||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4470
71871293|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.2804||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2804
71871294|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.1835||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1835
71871295|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.0103||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0103
71871296|NCT00706433|143260028|SUPERIORITY_OR_OTHER|||||||0.1319||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1319
71871297|NCT00706433|143260029|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871298|NCT00706433|143260030|SUPERIORITY_OR_OTHER|||||||0.4378||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4378
71871299|NCT00706433|143260031|SUPERIORITY_OR_OTHER|||||||0.343||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3430
71871300|NCT00706433|143260032|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871301|NCT00706433|143260033|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871302|NCT00706433|143260034|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871303|NCT00706433|143260035|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871304|NCT00706433|143260036|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871305|NCT00706433|143260037|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871306|NCT00706433|143260038|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871307|NCT00706433|143260039|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871308|NCT00706433|143260040|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871309|NCT00706433|143260041|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871310|NCT00706433|143260042|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71914662|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|1.62||0.927|TWO_SIDED|95.0|-3.03|3.33|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.33|-3.03|0.927
71914663|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|1.61||0.547|TWO_SIDED|95.0|-2.18|4.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.12|-2.18|0.547
71914664|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.58||0.304|TWO_SIDED|95.0|-1.47|4.71|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||4.71|-1.47|0.304
71914665|NCT00565812|143350920|SUPERIORITY_OR_OTHER||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|1.57||0.679|TWO_SIDED|95.0|-3.73|2.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.43|-3.73|0.679
71914666|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|1.11||0.738|TWO_SIDED|95.0|-1.8|2.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.55|-1.80|0.738
71914667|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.11||0.632|TWO_SIDED|95.0|-2.7|1.64|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-2.70|0.632
71914668|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|1.21||0.736|TWO_SIDED|95.0|-2.77|1.96|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-2.77|0.736
71914669|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|1.21||0.811|TWO_SIDED|95.0|-2.66|2.08|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.08|-2.66|0.811
71914670|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-1.22|STANDARD_ERROR_OF_MEAN|1.27||0.335|TWO_SIDED|95.0|-3.71|1.26|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.26|-3.71|0.335
71914671|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|1.26||0.966|TWO_SIDED|95.0|-2.52|2.41|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.41|-2.52|0.966
71914672|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-1.44|STANDARD_ERROR_OF_MEAN|1.38||0.299|TWO_SIDED|95.0|-4.16|1.28|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.28|-4.16|0.299
71914673|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.37||0.925|TWO_SIDED|95.0|-2.56|2.82|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.82|-2.56|0.925
71914674|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.39||0.676|TWO_SIDED|95.0|-2.14|3.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|-2.14|0.676
71914675|NCT00565812|143350921|SUPERIORITY_OR_OTHER||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|1.38||0.732|TWO_SIDED|95.0|-3.18|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.23|-3.18|0.732
71871311|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||0.0165||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0165
71914676|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.2||0.911|TWO_SIDED|95.0|-2.22|2.49|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.49|-2.22|0.911
71871312|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||0.2252||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2252
71871313|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||0.0179||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0179
71871314|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||0.0233||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0233
71871315|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1573
71871316|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||0.2039||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2039
71871317|NCT00706433|143260043|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871318|NCT00706433|143260044|SUPERIORITY_OR_OTHER|||||||0.1594||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1594
71871319|NCT00706433|143260045|SUPERIORITY_OR_OTHER|||||||0.5838||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5838
71871320|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0064
71871321|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||0.0939||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0939
71871322|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3173
71871323|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||0.2207||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2207
71871324|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||0.0183||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0183
71871325|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||0.0254||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0254
71871326|NCT00706433|143260046|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871327|NCT00706433|143260047|SUPERIORITY_OR_OTHER|||||||0.4753||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4753
71871328|NCT00706433|143260048|SUPERIORITY_OR_OTHER|||||||0.1728||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1728
71871329|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0002
71871330|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||0.5313||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.5313
71871331|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
71871332|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||0.0045||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0045
71871333|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||0.0012||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0012
71871334|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||0.0015||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0015
71871335|NCT00706433|143260049|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871336|NCT00706433|143260050|SUPERIORITY_OR_OTHER|||||||0.0892||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0892
71871337|NCT00706433|143260051|SUPERIORITY_OR_OTHER|||||||0.4575||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4575
71871338|NCT00706433|143260052|SUPERIORITY_OR_OTHER|||||||0.8848||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8848
71871339|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0008
71871340|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.4091||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4091
71871341|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.0176||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0176
71871342|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
71871343|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0020
71914677|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-3.16|1.54|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-3.16|0.500
71871344|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0022
71871345|NCT00706433|143260053|SUPERIORITY_OR_OTHER|||||||0.9372||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.9372
71871346|NCT00706433|143260054|SUPERIORITY_OR_OTHER|||||||0.239||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2390
71871347|NCT00706433|143260055|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871348|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||0.0463||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0463
71871349|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||0.1261||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.1261
71871350|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871351|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871352|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||0.0947||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0947
71871353|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||0.0886||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0886
71871354|NCT00706433|143260056|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871355|NCT00706433|143260057|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||<0.0001
71871356|NCT00706433|143260057|SUPERIORITY_OR_OTHER|||||||0.0255||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0255
71683201|NCT01782352|142884506|SUPERIORITY||Hazard Ratio (HR)|1.21|||<|0.05|TWO_SIDED|95.0|0.86|1.7|||Regression, Cox|||||1.70|0.86|<0.05
71683202|NCT01782352|142884506|SUPERIORITY||Hazard Ratio (HR)|0.84|||<|0.05|TWO_SIDED|95.0|0.59|1.17|||Regression, Cox|||||1.17|0.59|<0.05
71683203|NCT01782352|142884507|SUPERIORITY||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.81|1.84|||Regression, Cox|||||1.84|0.81|<0.05
71871357|NCT00706433|143260057|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0576
71871358|NCT00706433|143260057|SUPERIORITY_OR_OTHER|||||||0.0686||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0686
71871359|NCT00706433|143260057|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0004
71871360|NCT00706433|143260057|SUPERIORITY_OR_OTHER|||||||0.0005||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0005
71914678|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|1.26||0.596|TWO_SIDED|95.0|-1.81|3.15|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.15|-1.81|0.596
71914679|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|1.26||0.979|TWO_SIDED|95.0|-2.51|2.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-2.51|0.979
71914680|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-0.59|STANDARD_ERROR_OF_MEAN|1.33||0.659|TWO_SIDED|95.0|-3.2|2.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.03|-3.20|0.659
71914681|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|1.32||0.823|TWO_SIDED|95.0|-2.89|2.3|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-2.89|0.823
71914682|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|1.43||0.387|TWO_SIDED|95.0|-4.04|1.57|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-4.04|0.387
71914683|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|1.42||0.737|TWO_SIDED|95.0|-3.25|2.3|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-3.25|0.737
71914684|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|1.12|STANDARD_ERROR_OF_MEAN|1.45||0.443|TWO_SIDED|95.0|-1.73|3.97|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.97|-1.73|0.443
71914685|NCT00565812|143350922|SUPERIORITY_OR_OTHER||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|1.44||0.585|TWO_SIDED|95.0|-3.62|2.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.04|-3.62|0.585
71914686|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|0.58|STANDARD_ERROR_OF_MEAN|1.16||0.613|TWO_SIDED|95.0|-1.68|2.85|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-1.68|0.613
71914687|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.16||0.67|TWO_SIDED|95.0|-2.76|1.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-2.76|0.670
71871361|NCT00706433|143260057|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871362|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0006
71871363|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||0.0245||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0245
71871364|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871365|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871366|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||0.0097||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0097
71871367|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0146
71683204|NCT01782352|142884507|SUPERIORITY||Hazard Ratio (HR)|0.72|||<|0.05|TWO_SIDED|95.0|0.48|1.09|||Regression, Cox|||||1.09|0.48|<0.05
71871368|NCT00706433|143260058|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871369|NCT00706433|143260059|SUPERIORITY_OR_OTHER|||||||0.4235||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4235
71871370|NCT00706433|143260060|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871371|NCT00706433|143260061|SUPERIORITY_OR_OTHER|||||||0.0865||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0865
71871372|NCT00706433|143260062|SUPERIORITY_OR_OTHER|||||||0.623||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.6230
71871373|NCT00706433|143260063|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.0963
71871374|NCT00706433|143260064|SUPERIORITY_OR_OTHER|||||||0.4814||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.4814
71871375|NCT00706433|143260065|SUPERIORITY_OR_OTHER|||||||0.7153||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.7153
71871376|NCT00706433|143260066|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3832
71871377|NCT00706433|143260067|SUPERIORITY_OR_OTHER|||||||0.2908||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.2908
71871378|NCT00706433|143260068|SUPERIORITY_OR_OTHER|||||||0.8096||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.8096
71871379|NCT00706433|143260069|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3080
71871380|NCT00706433|143260070|SUPERIORITY_OR_OTHER|||||||0.3208||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||0.3208
71871381|NCT00706433|143260071|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871382|NCT00706433|143260072|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.||||1.0
71871383|NCT01236365|143260073|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Change in LDL-C between Atorvastatin and Placebo|Mixed Models Analysis|||||||<0.0001
71871384|NCT01236365|143260074|SUPERIORITY_OR_OTHER|||||||0.913|TWO_SIDED|||||Change in hsCRP (6months minus 0months) between Atorvastatin and Placebo|Wilcoxon (Mann-Whitney)|||||||0.913
71871385|NCT01236365|143260077|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71871386|NCT00717067|143260078|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|129.17||||||90.0|92.16|181.04|||ANOVA|||Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||181.04|92.16|
71871387|NCT00717067|143260078|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|88.31||||||90.0|61.97|125.83|||ANOVA|||Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||125.83|61.97|
71871388|NCT00717067|143260078|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|322.23||||||90.0|171.97|603.78|||ANOVA|||Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.||603.78|171.97|
71871389|NCT00717067|143260079|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|151.99||||||90.0|109.53|210.92|||ANOVA|||Ratio (%) test (mild) / reference (normal).||210.92|109.53|
71871390|NCT00717067|143260079|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|115.95||||||90.0|82.23|163.5|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||163.50|82.23|
71871391|NCT00717067|143260080|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|121.01||||||90.0|83.15|176.13|||ANOVA|||Ratio (%) test (mild) / reference (normal).||176.13|83.15|
71871392|NCT00717067|143260080|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|70.9||||||90.0|47.83|105.1|||ANOVA|||Ratio (%) test (moderate) / reference (normal).||105.10|47.83|
71871393|NCT00717067|143260080|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|238.73||||||90.0|106.83|533.48|||ANOVA|||Ratio (%) test (severe) / reference (normal).||533.48|106.83|
71871394|NCT00717067|143260082|SUPERIORITY_OR_OTHER||ratio of adjusted geometric means|323.91||||||90.0|174.32|601.88|||ANOVA|||Ratio (%) test (severe) / reference (normal).||601.88|174.32|
71871395|NCT00440999|143260122|NON_INFERIORITY|The primary efficacy analysis tested the non-inferiority of the PA group compared to the comparator group with regard to the crude cure rate on Day 14 using the 2-sided 95% confidence interval (CI) (Newcombe-Wilson score method without continuity correction) and a 10% non-inferiority margin. Non-inferiority was claimed if the lower limit of the 2-sided 95% CI for the difference in cure rates on Day 14 was \>10%.|Difference in cure rate|-0.5|||||TWO_SIDED|95.0|-2.6|1.4|||||Conclusion: non-inferiority between PA \& chloroquine.|"Null hypothesis: The cure rate on Day 14 for the PA group is inferior to the cure rate on Day 14 for the chloroquine group by more than 10%.~Was tested against the alternative:~Alternative hypothesis: The cure rate on Day 14 for the PA group was not inferior to the cure rate on Day 14 for the chloroquine group by more than 10%."||1.4|-2.6|
71871396|NCT02700945|143260131|SUPERIORITY|The 12-month Kaplan-Meier estimate will be reported for each arm. The hazard ratio estimate for the treatment effect with its 95% confidence interval will be reported.|Hazard Ratio (HR)|7.4|||<|0.001|TWO_SIDED|95.0|2.6|21.3||A priori threshold is .05|Log Rank||A hazard ratio of \> 1 indicates that continuous monitoring arm is superior to control arm in detecting AF.|H0: h(t) = hT(t) for t ≤ 12 months HA: hC(t) ≠ hT(t) for t ≤ 12 months where hT(t) and hC(t) are the hazard functions of first detected and adjudicated AF at time t for subjects with and without the Reveal LINQ diagnostics for AF, respectively. Hazard functions and survival functions are transformations of each other.||21.3|2.6|<0.001
71683205|NCT01782352|142884508|SUPERIORITY||Hazard Ratio (HR)|1.09|||<|0.05|TWO_SIDED|95.0|0.86|1.37|||Regression, Cox|||||1.37|0.86|<0.05
71871397|NCT04745026|143260133|SUPERIORITY||Least square mean difference|3.37|STANDARD_ERROR_OF_MEAN|1.931|=|0.085|TWO_SIDED|95.0|-0.48|7.21||Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).|Mixed models for repeated measures|||Irritability (Week 12)||7.21|-0.48|=0.085
71871398|NCT04745026|143260133|SUPERIORITY||Least square mean difference|1.14|STANDARD_ERROR_OF_MEAN|1.16|=|0.3107|TWO_SIDED|95.0|-1.08|3.36|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Social Withdrawal Week 12)||3.36|-1.08|=0.3107
71914688|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-1.33|STANDARD_ERROR_OF_MEAN|1.27||0.296|TWO_SIDED|95.0|-3.82|1.16|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-3.82|0.296
71914689|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|1.27||0.604|TWO_SIDED|95.0|-3.15|1.83|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.83|-3.15|0.604
71914690|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-1.86|STANDARD_ERROR_OF_MEAN|1.33||0.163|TWO_SIDED|95.0|-4.46|0.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.75|-4.46|0.163
71914691|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|1.32||0.939|TWO_SIDED|95.0|-2.69|2.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-2.69|0.939
71914692|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-1.74|STANDARD_ERROR_OF_MEAN|1.46||0.233|TWO_SIDED|95.0|-4.61|1.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.12|-4.61|0.233
71914693|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|1.45||0.72|TWO_SIDED|95.0|-2.32|3.36|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.36|-2.32|0.720
71914694|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.45||0.993|TWO_SIDED|95.0|-2.82|2.85|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.85|-2.82|0.993
71914695|NCT00565812|143350923|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.44||0.794|TWO_SIDED|95.0|-3.19|2.44|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-3.19|0.794
71871399|NCT04745026|143260133|SUPERIORITY||Least square mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.695|=|0.9513|TWO_SIDED|95.0|-1.34|1.42|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Stereotypic Behavior (Week 12)||1.42|-1.34|=0.9513
71871400|NCT04745026|143260133|SUPERIORITY||Least square mean difference|2.01|STANDARD_ERROR_OF_MEAN|1.943|=|0.305|TWO_SIDED|95.0|-1.86|5.88|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Hyperactivity/Noncompliance (Week 12)||5.88|-1.86|=0.305
71914696|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.97|STANDARD_ERROR_OF_MEAN|0.53||0.069|TWO_SIDED|95.0|-0.07|2.02|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|-0.07|0.069
71914697|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.54||0.335|TWO_SIDED|95.0|-0.53|1.57|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.57|-0.53|0.335
71914698|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.62||0.153|TWO_SIDED|95.0|-0.33|2.11|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.11|-0.33|0.153
71683206|NCT01782352|142884508|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.73|1.17|||Regression, Cox|||||1.17|0.73|<0.05
71683207|NCT01782352|142884509|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.05|TWO_SIDED|95.0|0.33|1.21|||Regression, Cox|||||1.21|0.33|<0.05
71914699|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.672|TWO_SIDED|95.0|-0.95|1.47|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.47|-0.95|0.672
71683208|NCT01782352|142884509|SUPERIORITY||Hazard Ratio (HR)|1.05|||<|0.05|TWO_SIDED|95.0|0.56|1.97|||Regression, Cox|||||1.97|0.56|<0.05
71683209|NCT01782352|142884510|SUPERIORITY||Hazard Ratio (HR)|0.93|||<|0.05|TWO_SIDED|95.0|0.69|1.25|||Regression, Cox|||||1.25|0.69|<0.05
71914700|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.19|STANDARD_ERROR_OF_MEAN|0.63||0.765|TWO_SIDED|95.0|-1.05|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.43|-1.05|0.765
71914701|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.62||0.675|TWO_SIDED|95.0|-0.96|1.49|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.96|0.675
71914702|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.72||0.56|TWO_SIDED|95.0|-1.0|1.84|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.84|-1.00|0.560
71914703|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.72||0.433|TWO_SIDED|95.0|-0.84|1.97|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.97|-0.84|0.433
71914704|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|0.73||0.318|TWO_SIDED|95.0|-0.7|2.16|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|-0.70|0.318
71914705|NCT00565812|143350924|SUPERIORITY_OR_OTHER||LS mean difference|0.75|STANDARD_ERROR_OF_MEAN|0.73||0.303|TWO_SIDED|95.0|-0.68|2.18|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.18|-0.68|0.303
71914706|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|1.67|STANDARD_ERROR_OF_MEAN|0.81||0.039|TWO_SIDED|95.0|0.08|3.26|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLGU\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.26|0.08|0.039
71914707|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.7|STANDARD_ERROR_OF_MEAN|0.82||0.395|TWO_SIDED|95.0|-0.91|2.3|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.91|0.395
71914708|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|0.96||0.16|TWO_SIDED|95.0|-0.54|3.25|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.25|-0.54|0.160
71914709|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.46|STANDARD_ERROR_OF_MEAN|0.97||0.638|TWO_SIDED|95.0|-1.44|2.35|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.35|-1.44|0.638
71914710|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.98||0.537|TWO_SIDED|95.0|-1.32|2.54|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.54|-1.32|0.537
71914711|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.98||0.988|TWO_SIDED|95.0|-1.9|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*(visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.93|-1.90|0.988
71914712|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.05|STANDARD_ERROR_OF_MEAN|1.11||0.962|TWO_SIDED|95.0|-2.12|2.22|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.22|-2.12|0.962
71914713|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|1.11||0.856|TWO_SIDED|95.0|-1.97|2.37|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-1.97|0.856
71914714|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|1.36|STANDARD_ERROR_OF_MEAN|1.15||0.237|TWO_SIDED|95.0|-0.9|3.63|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.63|-0.90|0.237
71914715|NCT00565812|143350925|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|1.15||0.475|TWO_SIDED|95.0|-1.44|3.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.09|-1.44|0.475
71914716|NCT00565812|143350926|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.57||0.938|TWO_SIDED|95.0|-1.07|1.16|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.16|-1.07|0.938
71914717|NCT00565812|143350926|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.56||0.906|TWO_SIDED|95.0|-1.04|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-1.04|0.906
71914718|NCT00565812|143350926|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.65||0.726|TWO_SIDED|95.0|-1.5|1.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.04|-1.50|0.726
71914719|NCT00565812|143350926|SUPERIORITY_OR_OTHER||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.64||0.681|TWO_SIDED|95.0|-1.52|1.0|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.00|-1.52|0.681
71914720|NCT00565812|143350927|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.58||0.9|TWO_SIDED|95.0|-1.07|1.21|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.21|-1.07|0.900
71914721|NCT00565812|143350927|SUPERIORITY_OR_OTHER||LS mean difference|0.36|STANDARD_ERROR_OF_MEAN|0.58||0.528|TWO_SIDED|95.0|-0.77|1.5|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.50|-0.77|0.528
71914722|NCT00565812|143350927|SUPERIORITY_OR_OTHER||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.647|TWO_SIDED|95.0|-1.51|0.94|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.94|-1.51|0.647
71914723|NCT00565812|143350927|SUPERIORITY_OR_OTHER||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.62||0.841|TWO_SIDED|95.0|-1.34|1.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.09|-1.34|0.841
71871401|NCT04745026|143260133|SUPERIORITY||Least square mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.517|=|0.4754|TWO_SIDED|95.0|-1.4|0.66|||Mixed models repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Inappropriate Speech (Week 12)||0.66|-1.4|=0.4754
71914724|NCT00565812|143350928|SUPERIORITY_OR_OTHER||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.59||0.587|TWO_SIDED|95.0|-0.84|1.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.48|-0.84|0.587
71914725|NCT00565812|143350928|SUPERIORITY_OR_OTHER||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.58||0.687|TWO_SIDED|95.0|-0.91|1.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.38|-0.91|0.687
71914726|NCT00565812|143350928|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.65||0.677|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.677
71914727|NCT00565812|143350928|SUPERIORITY_OR_OTHER||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.65||0.469|TWO_SIDED|95.0|-0.8|1.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.74|-0.80|0.469
71871402|NCT04745026|143260134|SUPERIORITY||Least square mean difference|0.45|STANDARD_ERROR_OF_MEAN|2.36|=|0.8506|TWO_SIDED|95.0|-4.26|5.15|||Mixed models for repeated measures|Randomization factors, baseline score, visit, treatment arm, visit by treatment arm (fixed), and visit repeated within each patient (repeated).||Week 12||5.15|-4.26|=0.8506
71871403|NCT04745026|143260135|SUPERIORITY||Odds Ratio (OR)|1.22|||=|0.7087|TWO_SIDED|95.0|0.43|3.51|||Regression, Logistic|Includes treatment arm, randomization variables and baseline score (CGI-S) covariates. Responders achieved a score of 1 or 2 at post-baseline visits.||Responders with 'Very Much Improved' or 'Much Improved' response at week 12||3.51|0.43|=0.7087
71871404|NCT04745026|143260136|SUPERIORITY||||||=|0.6108|||||||Cochran-Mantel-Haenszel|||Week 12||||=0.6108
71871405|NCT04426851|143260156|OTHER||Ratio of the geometric means (%)|45.9|||||TWO_SIDED|90.0|41.4|50.9|||||"Ratio was calculated as: BI 1358894 100 mg tablet fasted/BI 1358894 (C-14) 100 ug i.v.~Intra-individual geometric coefficient of variation (gCV)=14.3."|The Analysis of variance (ANOVA) model included effects accounting for the following sources of variation: 'subjects' and 'formulation'. The effect 'subjects' was considered as random, whereas 'formulation' was considered as fixed.||50.9|41.4|
71871406|NCT04426851|143260157|OTHER||Ratio of the geometric means (%)|141.4|||||TWO_SIDED|90.0|129.3|154.6|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra -individual geometric coefficient of variation (gCV)=10.9.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||154.6|129.3|
71871407|NCT04426851|143260159|OTHER||Ratio of the geometric means (%)|65.3|||||TWO_SIDED|90.0|54.6|78.0|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV)=22.5.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||78.0|54.6|
71871408|NCT04426851|143260160|OTHER||Ratio of the geometric means (%)|148.4|||||TWO_SIDED|90.0|138.1|159.5|||||Ratio was calculated as: BI 1358894 100 mg oral suspension fed/BI 1358894 100 mg oral suspension fasted. Intra - individual geometric coefficient of variation (gCV) =8.7.|The ANOVA model included effects accounting for the following sources of variation: 'sequence or block', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||159.5|138.1|
71871409|NCT00825916|143260174|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.078
71914728|NCT00565812|143350929|SUPERIORITY_OR_OTHER||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|0.48||0.632|TWO_SIDED|95.0|-0.71|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.17|-0.71|0.632
71871410|NCT00825916|143260174|SUPERIORITY_OR_OTHER|||||||0.086||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.086
71871411|NCT00825916|143260174|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
71871412|NCT00825916|143260174|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.49
71871413|NCT00825916|143260175|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.74
71871414|NCT00825916|143260175|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
71871415|NCT00825916|143260175|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
71871416|NCT00825916|143260175|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||1.00
71871417|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.34||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.34
71914729|NCT00565812|143350929|SUPERIORITY_OR_OTHER||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|0.48||0.308|TWO_SIDED|95.0|-0.45|1.42|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-0.45|0.308
71914730|NCT00565812|143350929|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.54||0.615|TWO_SIDED|95.0|-1.33|0.79|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.79|-1.33|0.615
71914731|NCT00565812|143350929|SUPERIORITY_OR_OTHER||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.53||0.425|TWO_SIDED|95.0|-1.48|0.62|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.62|-1.48|0.425
71914732|NCT00565812|143350930|SUPERIORITY_OR_OTHER||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.54||0.214|TWO_SIDED|95.0|-0.39|1.72|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.72|-0.39|0.214
71914733|NCT00565812|143350930|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.53||0.98|TWO_SIDED|95.0|-1.06|1.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.03|-1.06|0.980
71914734|NCT00565812|143350930|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.575|TWO_SIDED|95.0|-0.83|1.49|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.49|-0.83|0.575
71914735|NCT00565812|143350930|SUPERIORITY_OR_OTHER||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.59||0.986|TWO_SIDED|95.0|-1.16|1.14|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-1.16|0.986
71914736|NCT00565812|143350931|SUPERIORITY_OR_OTHER||LS mean difference|1.33|STANDARD_ERROR_OF_MEAN|0.61||0.03|TWO_SIDED|95.0|0.13|2.52|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.52|0.13|0.030
71914737|NCT00565812|143350931|SUPERIORITY_OR_OTHER||LS mean difference|0.43|STANDARD_ERROR_OF_MEAN|0.6||0.48|TWO_SIDED|95.0|-0.76|1.61|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-0.76|0.480
71683210|NCT01782352|142884510|SUPERIORITY||Hazard Ratio (HR)|0.9|||<|0.05|TWO_SIDED|95.0|0.67|1.21|||Regression, Cox|||||1.21|0.67|<0.05
71914738|NCT00565812|143350931|SUPERIORITY_OR_OTHER||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.67||0.132|TWO_SIDED|95.0|-0.3|2.32|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.32|-0.30|0.132
71914739|NCT00565812|143350931|SUPERIORITY_OR_OTHER||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|0.66||0.117|TWO_SIDED|95.0|-0.26|2.34|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.26|0.117
71914740|NCT00565812|143350932|SUPERIORITY_OR_OTHER||LS mean difference|1.06|STANDARD_ERROR_OF_MEAN|0.71||0.133|TWO_SIDED|95.0|-0.32|2.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.44|-0.32|0.133
71683211|NCT02267135|142884518|SUPERIORITY_OR_OTHER_LEGACY||Difference between percentages|51.0|||<|0.001|TWO_SIDED|95.0|37.0|65.0|||Cochran-Mantel-Haenszel|adjusted for body weight (\< 90 kg, ≥ 90 kg)||||65|37|<0.001
71914741|NCT00565812|143350932|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.7||0.524|TWO_SIDED|95.0|-0.93|1.82|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.82|-0.93|0.524
71914742|NCT00565812|143350932|SUPERIORITY_OR_OTHER||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.78||0.743|TWO_SIDED|95.0|-1.27|1.78|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-1.27|0.743
71914743|NCT00565812|143350932|SUPERIORITY_OR_OTHER||LS mean difference|0.78|STANDARD_ERROR_OF_MEAN|0.77||0.31|TWO_SIDED|95.0|-0.73|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.73|0.310
71914744|NCT00565812|143350933|SUPERIORITY_OR_OTHER||LS mean difference|1.17|STANDARD_ERROR_OF_MEAN|0.62||0.058|TWO_SIDED|95.0|-0.04|2.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.38|-0.04|0.058
71914745|NCT00565812|143350933|SUPERIORITY_OR_OTHER||LS mean difference|0.76|STANDARD_ERROR_OF_MEAN|0.61||0.213|TWO_SIDED|95.0|-0.44|1.96|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.96|-0.44|0.213
71914746|NCT00565812|143350933|SUPERIORITY_OR_OTHER||LS mean difference|0.98|STANDARD_ERROR_OF_MEAN|0.67||0.143|TWO_SIDED|95.0|-0.33|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.30|-0.33|0.143
71914747|NCT00565812|143350933|SUPERIORITY_OR_OTHER||LS mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.67||0.45|TWO_SIDED|95.0|-0.8|1.81|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.81|-0.80|0.450
71914748|NCT00565812|143350934|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.701|TWO_SIDED|95.0|-1.19|0.8|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.80|-1.19|0.701
71914749|NCT00565812|143350934|SUPERIORITY_OR_OTHER||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.5||0.764|TWO_SIDED|95.0|-0.84|1.14|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.14|-0.84|0.764
71914750|NCT00565812|143350934|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.57||0.228|TWO_SIDED|95.0|-1.8|0.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.43|-1.80|0.228
71914751|NCT00565812|143350934|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.56||0.514|TWO_SIDED|95.0|-1.47|0.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.74|-1.47|0.514
71914752|NCT00565812|143350935|SUPERIORITY_OR_OTHER||LS mean difference|1.42|STANDARD_ERROR_OF_MEAN|0.62||0.023|TWO_SIDED|95.0|0.19|2.65|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.65|0.19|0.023
71914753|NCT00565812|143350935|SUPERIORITY_OR_OTHER||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.62||0.391|TWO_SIDED|95.0|-0.68|1.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.75|-0.68|0.391
71914754|NCT00565812|143350935|SUPERIORITY_OR_OTHER||LS mean difference|1.02|STANDARD_ERROR_OF_MEAN|0.69||0.142|TWO_SIDED|95.0|-0.34|2.37|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.37|-0.34|0.142
71871418|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.98
71871419|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.15
71871420|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.83
71871421|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.95
71871422|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.59||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.59
71871423|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.76
71871424|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.63
71871425|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.92
71871426|NCT00825916|143260176|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.69
71871427|NCT00825916|143260177|SUPERIORITY_OR_OTHER|||||||0.95|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.95
71871428|NCT00825916|143260177|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.76
71871429|NCT00825916|143260177|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.60
71914755|NCT00565812|143350935|SUPERIORITY_OR_OTHER||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|0.68||0.204|TWO_SIDED|95.0|-0.47|2.21|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.21|-0.47|0.204
71914756|NCT00565812|143350942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.952||||0.875|TWO_SIDED|95.0|0.516|1.756|||Regression, Logistic|||Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.756|0.516|0.875
71914757|NCT00565812|143350942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.273||||0.406|TWO_SIDED|95.0|0.721|2.247|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.247|0.721|0.406
71914758|NCT00565812|143350942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.787||||0.406|TWO_SIDED|95.0|0.448|1.384|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.384|0.448|0.406
71914759|NCT00565812|143350942|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.154||||0.591|TWO_SIDED|95.0|0.685|1.942|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.942|0.685|0.591
71914760|NCT00565812|143350943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.704||||0.168|TWO_SIDED|95.0|0.428|1.16|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.160|0.428|0.168
71914761|NCT00565812|143350943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.893||||0.634|TWO_SIDED|95.0|0.56|1.423|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.423|0.560|0.634
71914762|NCT00565812|143350943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.583||||0.032|TWO_SIDED|95.0|0.356|0.955|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.955|0.356|0.032
71914763|NCT00565812|143350943|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.774||||0.276|TWO_SIDED|95.0|0.489|1.227|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.227|0.489|0.276
71914764|NCT00565812|143350944|SUPERIORITY_OR_OTHER||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.709|TWO_SIDED|95.0|-0.21|0.14|||ANCOVA|||LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.14|-0.21|0.709
71914765|NCT00565812|143350944|SUPERIORITY_OR_OTHER||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.09||0.798|TWO_SIDED|95.0|-0.15|0.2|||ANCOVA|||LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.||0.20|-0.15|0.798
71914766|NCT00565812|143350945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||0.81|TWO_SIDED|95.0|0.797|1.337|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.337|0.797|0.810
71914767|NCT00565812|143350945|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.068||||0.62|TWO_SIDED|95.0|0.824|1.383|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.||1.383|0.824|0.620
71914768|NCT00565812|143350946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.745||||0.047|TWO_SIDED|95.0|0.557|0.997|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||0.997|0.557|0.047
71871430|NCT00825916|143260177|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.44
71871431|NCT00825916|143260177|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.85
71871432|NCT00825916|143260177|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.83
71871433|NCT01778023|143260189|SUPERIORITY_OR_OTHER||Treatment Difference|5.15|||<|0.0001|TWO_SIDED|95.0|4.09|6.21|||ANOVA|The HV after 6 months of treatment was analysed using an ANCOVA method with group and sex as fixed effects, and age as a covariate.||Let D be a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.||6.21|4.09|<0.0001
71871434|NCT03086213|143260232|NON_INFERIORITY|the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.|Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|0.025||0.025|TWO_SIDED|95.0|5.0|95.0||whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance|t-test, 2 sided|degrees of freedom|Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk|null hypothesis||95|5|0.025
71871435|NCT03086213|143260233|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level|||||<|0.05||||||the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.|t-test, 2 sided|degrees of freedom is defined as sample size subtraction one.||null hypothesis||||<0.05
71871436|NCT03086213|143260236|SUPERIORITY|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference-if any-as statistically significant at the 5% level||||||0.05|||||||t-test, 2 sided|Degree of freedom is defined as sample size subtraction one.||null hypothesis||||0.05
71871437|NCT01616056|143260256|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71871438|NCT01616056|143260258|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71871439|NCT01616056|143260260|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71871440|NCT01616056|143260263|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71871441|NCT00138671|143260279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||||90.0|-0.17|0.36||||||Week 6||0.36|-0.17|
71871442|NCT00138671|143260279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||||90.0|-0.27|0.26||||||Week 12||0.26|-0.27|
71871443|NCT00138671|143260279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||||90.0|-0.29|0.26||||||Week 26||0.26|-0.29|
71871444|NCT00138671|143260279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||||90.0|-0.36|0.2||||||Week 39||0.20|-0.36|
71871445|NCT00138671|143260279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||||90.0|-0.23|0.35||||||Week 52||0.35|-0.23|
71871446|NCT00138671|143260279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||||90.0|-0.29|0.31||||||Week 52 LOCF||0.31|-0.29|
71871447|NCT00138671|143260280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.475||||||90.0|-23.47|14.518||||||Week 6||14.518|-23.47|
71871448|NCT00138671|143260280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.91||||||90.0|-30.04|8.232||||||Week 12||8.232|-30.04|
71871449|NCT00138671|143260280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.84||||||90.0|-42.51|-3.166||||||Week 26||-3.166|-42.51|
71871450|NCT00138671|143260280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.222||||||90.0|-28.52|12.075||||||Week 39||12.075|-28.52|
71871451|NCT00138671|143260280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.329||||||90.0|-29.27|12.616||||||Week 52||12.616|-29.27|
71871452|NCT00138671|143260280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.406||||||90.0|-13.7|16.514||||||Week 52 LOCF||16.514|-13.70|
71871453|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.884||||||90.0|-0.317|2.084||||||Week 1||2.084|-0.317|
71871454|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||||90.0|-0.728|1.668||||||Week 2||1.668|-0.728|
71871455|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.382||||||90.0|-0.815|1.579||||||Week 3||1.579|-0.815|
71871456|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.405||||||90.0|-0.793|1.602||||||Week 4||1.602|-0.793|
71871457|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.562||||||90.0|-0.642|1.766||||||Week 6||1.766|-0.642|
71871458|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.416||||||90.0|-0.809|1.641||||||Week 9||1.641|-0.809|
71871459|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.019||||||90.0|-1.416|1.454||||||Week 11||1.454|-1.416|
71871460|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||||90.0|-1.127|1.308||||||Week 12||1.308|-1.127|
71871461|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.309||||||90.0|-1.551|0.934||||||Week 18||0.934|-1.551|
71871462|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.869||||||90.0|-2.123|0.384||||||Week 26||0.384|-2.123|
71871463|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.664||||||90.0|-2.968|-0.36||||||Week 39||-0.360|-2.968|
71871464|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.116||||||90.0|-3.829|-0.403||||||Week 50||-0.403|-3.829|
71871465|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.801||||||90.0|-3.204|-0.397||||||Week 51||-0.397|-3.204|
71871466|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.026||||||90.0|-3.384|-0.668||||||Week 52||-0.668|-3.384|
71871467|NCT00138671|143260281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.451||||||90.0|-3.003|0.101||||||Week 52 LOCF||0.101|-3.003|
71871468|NCT01831856|143260299|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.5749|TWO_SIDED|95.0|0.71|1.85|||Log Rank|||The primary criterion, time to first Atrial Fibrillation (AF) recurrence or atrial flutter emergence, was described using survival curves according to the Kaplan-Meier method, reporting the first and third quartiles (Q1, Q3), median, and 95% confidence interval. The time to first AF recurrence or atrial flutter emergence was compared between treatment groups using the Log rank test. Hazard ratios and 95% confidence intervals were estimated with the Cox regression model.||1.85|0.71|0.5749
71871469|NCT01078675|143260310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.88|STANDARD_DEVIATION|18.222|<|0.001|TWO_SIDED|-42.88|-45.44|-40.32||P-value\<0.001 at Month 24. No adjustment for multiple comparisons is made for individual age group.|ANCOVA|P-value is two-sided and based on ANCOVA using age group as the fixed factor, and study centre and the baseline value as covariates.||||-40.32|-45.44|<0.001
71871470|NCT01191268|143260335|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.22|||<|0.001|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.||-0.07|-0.38|<0.001
71871471|NCT01191268|143260335|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.17|||<|0.001|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.33|<0.001
71871472|NCT01191268|143260335|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.22||||0.005|TWO_SIDED|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.38|0.005
71871473|NCT01191268|143260335|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.015|TWO_SIDED|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.33|0.015
71871474|NCT01191268|143260336|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.25|||<|0.001|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.07|-0.42|<0.001
71871475|NCT01191268|143260336|NON_INFERIORITY_OR_EQUIVALENCE|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.19|||<|0.001|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||||-0.02|-0.37|<0.001
71871476|NCT01191268|143260336|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.07|-0.42|0.005
71871477|NCT01191268|143260336|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19||||0.014|TWO_SIDED|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.||-0.02|-0.37|0.014
71871478|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.014||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.014
71871479|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic|||||||0.010
71871480|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.027||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.027
71871481|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.384||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic|||||||0.384
71871482|NCT01191268|143260337|SUPERIORITY_OR_OTHER||||||<|0.05||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||<0.05
71871483|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.25||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic|||||||0.250
71871484|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.272||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.272
71871485|NCT01191268|143260337|SUPERIORITY_OR_OTHER|||||||0.623||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic|||||||0.623
71871486|NCT01191268|143260338|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
71871487|NCT01191268|143260338|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic|||||||<0.001
71871488|NCT01191268|143260338|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
71871489|NCT01191268|143260338|SUPERIORITY_OR_OTHER||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic|||||||<0.001
71914769|NCT00565812|143350946|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.864||||0.317|TWO_SIDED|95.0|0.65|1.15|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.150|0.650|0.317
71914770|NCT00565812|143350947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.043||||0.881|TWO_SIDED|95.0|0.602|1.806|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||1.806|0.602|0.881
71914771|NCT00565812|143350947|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.186||||0.525|TWO_SIDED|95.0|0.701|2.009|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.||2.009|0.701|0.525
71914772|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.63||0.668|TWO_SIDED|95.0|-1.5|0.96|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.96|-1.50|0.668
71871490|NCT01191268|143260339|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.628|TWO_SIDED|95.0|-0.35|0.21||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.21|-0.35|0.628
71871491|NCT01191268|143260339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.368|TWO_SIDED|95.0|-0.15|0.41||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis|||||0.41|-0.15|0.368
71871492|NCT01191268|143260339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.37|TWO_SIDED|95.0|-0.16|0.42||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.42|-0.16|0.370
71871493|NCT01191268|143260339|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.879|TWO_SIDED|95.0|-0.26|0.3||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis|||||0.30|-0.26|0.879
71871494|NCT01191268|143260340|SUPERIORITY_OR_OTHER||LS Mean Difference|1.31|||<|0.001|TWO_SIDED|95.0|0.83|1.79||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||1.79|0.83|<0.001
71871495|NCT01191268|143260340|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8|||<|0.001|TWO_SIDED|95.0|1.32|2.28||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||2.28|1.32|<0.001
71871496|NCT01191268|143260340|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|||<|0.001|TWO_SIDED|95.0|0.55|1.64||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.64|0.55|<0.001
71871497|NCT01191268|143260340|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42|||<|0.001|TWO_SIDED|95.0|0.88|1.96||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||1.96|0.88|<0.001
71871498|NCT01191268|143260342|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|||<|0.001|TWO_SIDED|95.0|-3.81|-2.59||Treatment comparison at 26 weeks.|ANCOVA|||||-2.59|-3.81|<0.001
71871499|NCT01191268|143260342|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.15|||<|0.001|TWO_SIDED|95.0|-2.76|-1.54||Treatment comparison at 26 weeks.|ANCOVA|||||-1.54|-2.76|<0.001
71871500|NCT01191268|143260342|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.23|||<|0.001|TWO_SIDED|95.0|-3.99|-2.48||Treatment comparison at 52 weeks.|ANCOVA|||||-2.48|-3.99|<0.001
71683212|NCT03246061|142884671|SUPERIORITY||||||<|0.001||||||Interim Analysis p-value for significance of \<0.025 for an overall alpha of 0.05|ANCOVA|||Estimates and p-value from an ANCOVA with a factor of treatment group and a covariate of baseline ODI score. Values have been adjusted for multiple imputation. Note: 3 month visit is computed as post-treatment for the RF Ablation Arm, and post-randomization for the Control Arm.||||<0.001
71683213|NCT03246061|142884672|SUPERIORITY||||||<|0.001||||||Estimates and p-value from ANCOVA with a factor of treatment group and a covariate of baseline VAS score.|ANCOVA|||||||<0.001
71871501|NCT01191268|143260342|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.03|||<|0.001|TWO_SIDED|95.0|-2.78|-1.27||Treatment comparison at 52 weeks.|ANCOVA|||||-1.27|-2.78|<0.001
71871502|NCT01191268|143260344|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.2|||<|0.001|TWO_SIDED|95.0|-1.44|-0.96||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.96|-1.44|<0.001
71871503|NCT01191268|143260344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.79|||<|0.001|TWO_SIDED|95.0|-1.03|-0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis|||||-0.55|-1.03|<0.001
71871504|NCT01191268|143260344|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.24|||<|0.001|TWO_SIDED|95.0|-1.55|-0.94||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.94|-1.55|<0.001
71871505|NCT01191268|143260344|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.76|||<|0.001|TWO_SIDED|95.0|-1.06|-0.46||Treatment comparison at 52 weeks.|Mixed Models Analysis|||||-0.46|-1.06|<0.001
71871506|NCT02294227|143260366|SUPERIORITY||Odds Ratio (OR)|3.07||||0.0002|TWO_SIDED|95.0|1.66|5.66|||Chi-squared|||||5.66|1.66|0.0002
71871507|NCT02294227|143260366|SUPERIORITY||Odds Ratio (OR)|3.24||||0.0003|TWO_SIDED|95.0|1.76|5.97|||Chi-squared, Corrected|||||5.97|1.76|0.0003
71871508|NCT00899548|143260372|SUPERIORITY||Hazard Ratio (HR)|1.76||||0.0002|TWO_SIDED|95.0|1.23|2.52|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.52|1.23|.0002
71871509|NCT00899548|143260373|OTHER||Cox Proportional Hazard|1.19||||0.001|TWO_SIDED|95.0|1.07|1.32|||Regression, Cox|||Hazard ratio||1.32|1.07|0.001
71871510|NCT00899548|143260376|SUPERIORITY||Hazard Ratio (HR)|1.7||||0.001|TWO_SIDED|95.0|1.18|2.45|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.||||2.45|1.18|.001
71871511|NCT01209780|143260387|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-4.0|2.0||||||Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain||2|-4|
71871512|NCT01209780|143260387|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|10.0|||||TWO_SIDED|95.0|6.0|14.0||||||Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain||14|6|
71871513|NCT01209780|143260387|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|-1.0|||||TWO_SIDED|95.0|-5.0|3.0||||||Non-inferiority of investigational TIV to the control TIV against B influenza strain||3|-5|
71871514|NCT01209780|143260389|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.32|||||TWO_SIDED|95.0|1.11|1.56||||||Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain||1.56|1.11|
71871515|NCT01209780|143260389|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.34|1.64||||||Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain||1.64|1.34|
71871516|NCT01209780|143260389|NON_INFERIORITY_OR_EQUIVALENCE|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.07||||||Non-inferiority of investigational TIV to licensed control TIV against B influenza strain||1.07|0.85|
71871517|NCT05007808|143260395|SUPERIORITY|ANCOVA model with Change from Baseline to Week 4/EOT as the outcome (dependent) variable, treatment as the independent variable, and baseline score as covariate. The p-value was derived from the t-test for the comparison of adjusted LS means between the treatment groups.|LS Mean Difference|-0.19||||0.6742|TWO_SIDED|95.0|-1.081|0.701|||t-test, 2 sided|||||0.701|-1.081|0.6742
71914773|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.63||0.326|TWO_SIDED|95.0|-0.61|1.85|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.85|-0.61|0.326
71914774|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.66||0.679|TWO_SIDED|95.0|-1.56|1.01|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.01|-1.56|0.679
71914775|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|0.66||0.005|TWO_SIDED|95.0|0.57|3.14|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.14|0.57|0.005
71871518|NCT00511472|143260422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.1|STANDARD_ERROR_OF_MEAN|14.15||0.001|TWO_SIDED|90.0|22.71|69.5|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-Breakfast for Titration Group 1||69.50|22.71|0.001
71871519|NCT00511472|143260422|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.28|STANDARD_ERROR_OF_MEAN|13.67|<|0.001|TWO_SIDED|90.0|27.68|72.88|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2||72.88|27.68|<0.001
71871520|NCT00731120|143260436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.803||0.279|TWO_SIDED|95.0|-2.45|0.71||Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||P-values were tested at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||0.71|-2.45|0.279
71871521|NCT00731120|143260436|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.791||0.306|TWO_SIDED|95.0|-2.36|0.74||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||||0.74|-2.36|0.306
71871522|NCT02411357|143260446|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Chi-square trend test|||||||<.001
71871523|NCT01588496|143260455|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-29.78|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-40.94|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-18.62|-40.94|<0.001
71871524|NCT01588496|143260456|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-23.14|STANDARD_ERROR_OF_MEAN|5.81|<|0.001|TWO_SIDED|95.0|-34.83|-11.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-11.45|-34.83|<0.001
71871525|NCT01588496|143260457|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-22.89|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-33.72|-12.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-12.05|-33.72|<0.001
71871526|NCT01588496|143260458|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.83|STANDARD_ERROR_OF_MEAN|6.77||0.088|TWO_SIDED|95.0|-25.48|1.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||1.82|-25.48|0.088
71871527|NCT01588496|143260459|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-11.27|STANDARD_ERROR_OF_MEAN|5.86||0.088|TWO_SIDED|95.0|-23.11|0.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||0.56|-23.11|0.088
71871528|NCT01588496|143260460|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-30.93|STANDARD_ERROR_OF_MEAN|6.42|<|0.001|TWO_SIDED|95.0|-43.86|-18.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (\< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.||-18.00|-43.86|<0.001
71871529|NCT00953745|143260466|SUPERIORITY_OR_OTHER|||||||0.029||||||paired t-test thresholded at cluster level significance of p=0.001; family-wise error multiple comparisons corrected|t-test, 1 sided|||A region of increased relative Fluorodopa (FDOPA) uptake in the right medial caudate was anticipated for the aripiprazole augmentation responders over the 6 weeks of augmentation treatment (Weeks 10-16).||||0.029
71871530|NCT00953745|143260467|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71871531|NCT00953745|143260467|SUPERIORITY_OR_OTHER|||||||0.366|||||||t-test, 2 sided|||||||0.366
71871532|NCT01605292|143260488|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71871533|NCT01605292|143260489|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||t-test, 2 sided|||||||0.006
71871534|NCT01605292|143260490|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71871535|NCT01605292|143260491|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Fisher Exact|||||||0.56
71871536|NCT01605292|143260492|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71871537|NCT01605292|143260493|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared|||||||0.07
71871538|NCT01605292|143260494|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.75
71871539|NCT01605292|143260496|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||||||0.007
71871540|NCT02401867|143260498|NON_INFERIORITY_OR_EQUIVALENCE|We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar's test adjusted for analysis of clustered matched-pair data.||||||0.29||||||Statistical significance was determined at an a priori threshold of p \<0.05|McNemar|Degrees of freedom = 1||Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]||||.29
71871541|NCT02401867|143260498|SUPERIORITY_OR_OTHER||Kappa|0.75|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|0.58|0.92||A priori threshold: p\<0.05|Kappa||Using the asymptotic standard error assuming the null hypothesis.|Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.||0.92|0.58|<0.001
71871542|NCT02401867|143260498|SUPERIORITY_OR_OTHER||Sensitivity|71.43|||||TWO_SIDED|95.0|47.82|88.72|||||Used exact confidence intervals.|Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||88.72|47.82|
71871543|NCT02401867|143260498|NON_INFERIORITY_OR_EQUIVALENCE|Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|Specificity|98.18|||||TWO_SIDED|95.0|93.59|99.78|||||Used exact confidence intervals.|||99.78|93.59|
71871544|NCT02401867|143260498|SUPERIORITY_OR_OTHER||Positive Predictive Value|88.24|||||TWO_SIDED|95.0|63.56|98.54|||||Used exact confidence intervals.|Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.54|63.56|
71871545|NCT02401867|143260498|SUPERIORITY_OR_OTHER||Negative predictive value|94.74|||||TWO_SIDED|95.0|88.9|98.04|||||Used exact confidence intervals|Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).||98.04|88.90|
71871546|NCT02795429|143260504|SUPERIORITY||Odds Ratio (OR)|0.561|||||||||||Bayesian Logistic Regression Model||Posterior probability that the odds ratio (ORRspartalizumab +capmatinib to ORRspartalizumab) was ≥ 1|||||
71871547|NCT00362453|143260532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-118.8||||0.0005|TWO_SIDED|95.0|-183.66|-53.94|||Mixed Models Analysis|||||-53.94|-183.66|0.0005
71871548|NCT00362453|143260533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-324.6||||0.001|TWO_SIDED|95.0|-513.98|-135.22|||Mixed Models Analysis|||12 Week||-135.22|-513.98|0.001
71871549|NCT00362453|143260533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-183.2||||0.06|TWO_SIDED|95.0|-372.58|6.18|||Mixed Models Analysis|||24 Week||6.18|-372.58|0.06
71871550|NCT00362453|143260533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-105.3||||0.3|TWO_SIDED|95.0|-294.68|84.08|||Mixed Models Analysis|||48 week||84.08|-294.68|0.3
71871551|NCT00362453|143260534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.9||||0.1|TWO_SIDED|95.0|-53.04|7.24|||Mixed Models Analysis|||12 week||7.24|-53.04|0.1
71871552|NCT00362453|143260534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.8||||0.3|TWO_SIDED|95.0|-44.94|15.34|||Mixed Models Analysis|||24 week||15.34|-44.94|0.3
71871553|NCT00362453|143260534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.65||||0.8|TWO_SIDED|95.0|-33.79|26.49|||Mixed Models Analysis|||48 Week||26.49|-33.79|0.8
71871554|NCT00362453|143260535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.95||||0.05|TWO_SIDED|95.0|-131.81|-2.09|||Mixed Models Analysis|||24 Week||-2.09|-131.81|0.05
71871555|NCT00362453|143260535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-46.15||||0.2|TWO_SIDED|95.0|-111.01|18.71|||Mixed Models Analysis|||48 Week||18.71|-111.01|0.2
71871556|NCT00362453|143260536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.01|TWO_SIDED|95.0|-3.82|-0.49|||Mixed Models Analysis|||12 Week||-0.49|-3.82|0.01
71871557|NCT00362453|143260536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.4|TWO_SIDED|95.0|-2.31|1.02|||Mixed Models Analysis|||24 Week||1.02|-2.31|0.4
71871558|NCT00362453|143260536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||1|TWO_SIDED|95.0|-1.62|1.7|||Mixed Models Analysis|||48 weeks||1.70|-1.62|1.0
71871559|NCT00362453|143260537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.002|TWO_SIDED|95.0|-2.75|-0.66|||Mixed Models Analysis|||12 Week||-0.66|-2.75|0.002
71871560|NCT00362453|143260537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.3|TWO_SIDED|95.0|-1.58|0.51|||Mixed Models Analysis|||24 Week||0.51|-1.58|0.3
71871561|NCT00362453|143260537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.06|TWO_SIDED|95.0|-2.09|0.02|||Mixed Models Analysis|||48 Week||0.02|-2.09|0.06
71871562|NCT00362453|143260538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.88||||5e-05|TWO_SIDED|95.0|-15.91|-5.84|||Mixed Models Analysis|||12 Week||-5.84|-15.91|0.00005
71871563|NCT00362453|143260538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.12||||0.05|TWO_SIDED|95.0|-10.15|-0.08|||Mixed Models Analysis|||24 Week||-0.08|-10.15|0.05
71871564|NCT00362453|143260538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.02|TWO_SIDED|95.0|-11.06|-0.91|||Mixed Models Analysis|||48 Week||-0.91|-11.06|0.02
71871565|NCT00362453|143260539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.08||||0.1|TWO_SIDED|95.0|-10.34|110.5|||Mixed Models Analysis|||12 Week||110.50|-10.34|0.1
71871566|NCT00362453|143260539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|43.71||||0.1|TWO_SIDED|95.0|-15.07|102.5|||Mixed Models Analysis|||24 Week||102.50|-15.07|0.1
71871567|NCT00362453|143260539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.61||||0.7|TWO_SIDED|95.0|-49.36|78.59|||Mixed Models Analysis|||48 Weeks||78.59|-49.36|0.7
71871568|NCT00362453|143260540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.7|TWO_SIDED|95.0|-0.54|0.34|||Mixed Models Analysis|||12 Weeks||0.34|-0.54|0.7
71871569|NCT00362453|143260540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.7|TWO_SIDED|95.0|-0.37|0.52|||Mixed Models Analysis|||24 Weeks||0.52|-0.37|0.7
71871570|NCT00362453|143260540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.6|TWO_SIDED|95.0|-0.55|0.34|||Mixed Models Analysis|||48 weeks||0.34|-0.55|0.6
71871571|NCT00362453|143260541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.009|TWO_SIDED|95.0|-11.63|-1.77|||Mixed Models Analysis|||12 Week||-1.77|-11.63|0.009
71871572|NCT00362453|143260541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.04|TWO_SIDED|95.0|-10.23|-0.37|||Mixed Models Analysis|||24 Weeks||-0.37|-10.23|0.04
71871573|NCT00362453|143260541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.9||||0.0006|TWO_SIDED|95.0|-13.83|-3.97|||Mixed Models Analysis|||48 Week||-3.97|-13.83|0.0006
71871574|NCT00362453|143260542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.04|TWO_SIDED|95.0|0.03|1.39|||Mixed Models Analysis|||12 Weeks||1.39|0.03|0.04
71871575|NCT00362453|143260542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.02|TWO_SIDED|95.0|0.17|1.53|||Mixed Models Analysis|||24 Weeks||1.53|0.17|0.02
71871576|NCT00362453|143260542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.007|TWO_SIDED|95.0|0.28|1.64|||Mixed Models Analysis|||48 Weeks||1.64|0.28|0.007
71871577|NCT00362453|143260543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.43||||0.004|TWO_SIDED|95.0|2.5|12.36|||Mixed Models Analysis|||12 Weeks||12.36|2.50|0.004
71871578|NCT00362453|143260543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.51||||0.08|TWO_SIDED|95.0|-0.42|9.45|||Mixed Models Analysis|||24 Weeks||9.45|-0.42|0.08
71871579|NCT00362453|143260543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.32||||0.01|TWO_SIDED|95.0|1.38|11.25|||Mixed Models Analysis|||48 Weeks||11.25|1.38|0.01
71871580|NCT00362453|143260544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.9|TWO_SIDED|95.0|-6.15|6.57|||Mixed Models Analysis|||12 Weeks||6.57|-6.15|0.9
71871581|NCT00362453|143260544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||1|TWO_SIDED|95.0|-6.47|6.25|||Mixed Models Analysis|||24 Weeks||6.25|-6.47|1.0
71871582|NCT00362453|143260544|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.77||||0.1|TWO_SIDED|95.0|-1.59|11.13|||Mixed Models Analysis|||48 Weeks||11.13|-1.59|0.10
71871583|NCT02047643|143260552|OTHER|||||||0.45|||||||Fisher Exact|Two-sided Fisher Exact test||||||.45
71871584|NCT02047643|143260553|OTHER|||||||0.66|||||||Fisher Exact|Two-sided Fisher Exact test||||||.66
71871585|NCT04218084|143260640|OTHER|Mixed Model Repeated Measures analysis|Difference in LS mean|-7.73||||0.0043|TWO_SIDED|95.0|-13.03|-2.42|||Mixed Models for Repeated Measures|||Week 24||-2.42|-13.03|0.0043
71871586|NCT00712673|143260665|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.657|-0.312||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.312|-0.657|<0.0001
71871587|NCT00712673|143260665|SUPERIORITY_OR_OTHER||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.088|<|0.0001|TWO_SIDED|95.0|-0.54|-0.193||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(\<8.0,\>=8.0%),BMI(\<30,\>=30 kg/m\^2),country as fixed effects, baseline HbA1c as covariate.||-0.193|-0.540|<0.0001
71871588|NCT00298090|143260699|SUPERIORITY_OR_OTHER||Other|0.0||||0.55|TWO_SIDED|95.0|-0.8|1.48|||repeated measures model||A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.|||1.48|-0.80|0.55
71871589|NCT01718353|143260703|OTHER|||||||0.02|||||||ANOVA|||%ARNL change from baseline at Cycle 1 Day 8 in participants with ≥50% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥50% decrease in PSA at Cycle 4||||0.02
71871590|NCT01718353|143260711|OTHER|||||||0.0927|||||||ANOVA|||MTB change from baseline at Cycle 1 Day 8 in participants with ≥30% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥30% decrease in PSA at Cycle 4||||0.0927
71871591|NCT01691768|143260731|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).|Mean Difference (Final Values)|-0.47|||||TWO_SIDED|95.0|-1.16|0.21||||Univariate Linear Mixed Models were used to analyze primary outcome.|The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.|Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.|The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.|0.21|-1.16|
71871592|NCT01691768|143260731|NON_INFERIORITY|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)|Median Difference (Final Values)|-0.25|||||TWO_SIDED|95.0|-0.98|0.48||||Univariable Linear Mixed Models was used for the analyses|We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.|This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).||0.48|-0.98|
71914776|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.72||0.399|TWO_SIDED|95.0|-0.8|2.01|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.01|-0.80|0.399
71914777|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|2.52|STANDARD_ERROR_OF_MEAN|0.71|<|0.001|TWO_SIDED|95.0|1.12|3.92|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.92|1.12|<0.001
71914778|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.668|TWO_SIDED|95.0|-1.08|1.68|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.08|0.668
71914779|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|1.76|STANDARD_ERROR_OF_MEAN|0.7||0.012|TWO_SIDED|95.0|0.39|3.13|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.13|0.39|0.012
71683214|NCT01492101|142884679|OTHER|Two-sided log-rank test, stratified by geographic region, prior use of eribulin, and receptor status.|Hazard Ratio, log|0.872|||=|0.0835|TWO_SIDED|95.0|0.747|1.019|||Log Rank|||||1.019|0.747|= 0.0835
71683215|NCT01492101|142884680|SUPERIORITY||Hazard Ratio (HR)|0.926|||=|0.3017|TWO_SIDED|95.0|0.798|1.075|||Log Rank|||||1.075|0.798|= 0.3017
71683216|NCT01492101|142884685|EQUIVALENCE|\[2\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.8||||0.635|TWO_SIDED|95.0|-2.65|4.33|||F-test|||Global health status/QoL: change from baseline to last assessment (Week 56)||4.33|-2.65|0.635
71914780|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.75||0.109|TWO_SIDED|95.0|-0.27|2.67|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.67|-0.27|0.109
71914781|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|0.74||0.163|TWO_SIDED|95.0|-0.42|2.48|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.48|-0.42|0.163
71914782|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.73||0.424|TWO_SIDED|95.0|-2.02|0.85|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.85|-2.02|0.424
71914783|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.72||0.635|TWO_SIDED|95.0|-1.07|1.76|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.76|-1.07|0.635
71914784|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.75||0.855|TWO_SIDED|95.0|-1.34|1.61|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.61|-1.34|0.855
71914785|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|0.74||0.013|TWO_SIDED|95.0|0.38|3.3|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||3.30|0.38|0.013
71914786|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.81||0.292|TWO_SIDED|95.0|-2.44|0.73|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.73|-2.44|0.292
71914787|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.8||0.897|TWO_SIDED|95.0|-1.47|1.68|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.68|-1.47|0.897
71914788|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.84||0.39|TWO_SIDED|95.0|-2.36|0.92|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.92|-2.36|0.390
71914789|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.83||0.659|TWO_SIDED|95.0|-1.26|1.99|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.99|-1.26|0.659
71914790|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.8||0.847|TWO_SIDED|95.0|-1.73|1.42|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.42|-1.73|0.847
71914791|NCT00565812|143350951|SUPERIORITY_OR_OTHER||LS mean difference|0.77|STANDARD_ERROR_OF_MEAN|0.8||0.333|TWO_SIDED|95.0|-0.79|2.34|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.34|-0.79|0.333
71914792|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.42||0.238|TWO_SIDED|95.0|-1.31|0.32|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.31|0.238
71871593|NCT01691768|143260732|SUPERIORITY||Incidence rate ratio|0.96||||0.928|TWO_SIDED|95.0|0.4|2.35|||z-test|We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.|The power was not calculated for all the secondary outcomes.||2.35|0.40|0.928
71871594|NCT01691768|143260733|SUPERIORITY||incidence rate ratio|0.96||||0.895|TWO_SIDED|95.0|0.45|2.04|||z-test|We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.|Power was not calculated for all the secondary outcomes.||2.04|0.45|0.895
71871595|NCT01691768|143260734|SUPERIORITY||Risk Ratio (RR)|1.08||||0.304|TWO_SIDED|95.0|0.94|1.24|||Regression, Log-binomial|||Power was not calculated for all secondary outcomes.||1.24|0.94|0.304
71871596|NCT01691768|143260735|SUPERIORITY|||||||0.455|||||||t-test, 2 sided|||||||0.455
71871597|NCT01691768|143260737|SUPERIORITY||incidence rate ratio|0.33||||0.097|TWO_SIDED|95.0|0.06|1.32|||z-test||We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.|||1.32|0.06|0.097
71871598|NCT01691768|143260738|SUPERIORITY||Risk Ratio (RR)|0.91||||0.462|TWO_SIDED|95.0|0.7|1.18|||Regression, Log-binomial|||||1.18|0.70|0.462
71871599|NCT00887432|143260747|SUPERIORITY||Mean Difference (Net)|0.24||||0.431|TWO_SIDED|95.0|-0.36|0.84||Significance level of 0.05.|t-test, 2 sided|Paired t-test, df=86||Evaluated the change in PSA under the vitamin D and placebo conditions using the combined data (n=87).||0.84|-0.36|0.431
71871600|NCT00887432|143260748|SUPERIORITY|Comparing the mean PSA slopes between conditions (on vitamin D versus on placebo).|Mean Difference (Net)|-0.00019||||0.112|TWO_SIDED|95.0|-0.00042|0.000045||Significance level of 0.05.|Mixed Models Analysis|||||0.000045|-0.00042|0.112
71871601|NCT01275131|143260787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.95||||0.0009|TWO_SIDED|90.0|7.37|20.54|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 2/6||20.54|7.37|0.0009
71871602|NCT01275131|143260787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|18.14|||<|0.0001|TWO_SIDED|90.0|11.55|24.72|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 4/8||24.72|11.55|<0.0001
71871603|NCT01275131|143260789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|16.41|||<|0.0001|TWO_SIDED|90.0|11.86|20.97|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 2/7||20.97|11.86|<0.0001
71871604|NCT01275131|143260789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|14.1|||<|0.0001|TWO_SIDED|90.0|9.55|18.65|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 3/8||18.65|9.55|<0.0001
71871605|NCT01275131|143260789|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.32||||0.0552|TWO_SIDED|90.0|0.77|9.88|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 5/10||9.88|0.77|0.0552
71914793|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.41||0.815|TWO_SIDED|95.0|-0.72|0.91|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.91|-0.72|0.815
71914794|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.28|STANDARD_ERROR_OF_MEAN|0.42||0.508|TWO_SIDED|95.0|-0.54|1.1|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.10|-0.54|0.508
71871606|NCT01551212|143260804|SUPERIORITY||Mean Difference (Final Values)|4.09||||0.097|TWO_SIDED|95.0|-0.74|8.91|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||8.91|-0.74|0.097
71871607|NCT01551212|143260805|SUPERIORITY||Mean Difference (Final Values)|7.99||||0.0085|TWO_SIDED|95.0|2.06|13.92|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \> 30) covariate: baseline value||||13.92|2.06|0.0085
71871608|NCT01551212|143260806|SUPERIORITY|||||||0.699|||||||Fisher Exact|||||||0.699
71871609|NCT00705523|143260811|SUPERIORITY_OR_OTHER|||||||0.1|||||||Regression, Logistic|beta=-0.67, exp(beta)=0.51, chi-squared(1) = 0.2.71||Self-reported drinking results, as gathered by the TLFB, were compared by the generalized estimating equations (GEE) (Diggle et al., 1994), using Poisson models for counts of drinking and heavy drinking days, and logistic regression models for absence/presence binary indicators of drinking. In the GEE model, the pre-treatment of the response was included as a covariate, together with the treatment group indicator, and a linear time effect.||||0.10
71871610|NCT03110185|143260818|OTHER|Correlation||||||0.0761||||||Delirium Incidence. There were no multiple comparisons, but includes age as a regressor. a priori threshold was p \< 0.05.|Regression, Logistic|Generalized logistic regression for delirium incidence and total DMN fc with age as a regressor.||||||0.0761
71871611|NCT02112838|143260819|SUPERIORITY||Mean Difference (Final Values)|19.9||||0.97|TWO_SIDED|95.0|-910.6|950.5|||ANCOVA|||||950.5|-910.6|0.97
71871612|NCT02112838|143260819|SUPERIORITY||Mean Difference (Final Values)|-399.7||||0.4|TWO_SIDED|95.0|-1320.8|521.3|||ANCOVA|||||521.3|-1320.8|0.40
71871613|NCT03430206|143260837|OTHER|||||||0.206|||||||Regression, Negative Binomial|||||||0.206
71871614|NCT03430206|143260838|OTHER|||||||0.101|||||||Regression, Negative Binomial|||||||0.101
71871615|NCT03430206|143260839|OTHER|||||||0.371|||||||Regression, Negative Binomial|||||||0.371
71871616|NCT03430206|143260841|OTHER|||||||0.601|||||||Regression, Negative Binomial|||||||0.601
71871617|NCT03430206|143260842|OTHER|||||||0.738|||||||Regression, Negative Binomial|||||||0.738
71871618|NCT00529958|143260849|EQUIVALENCE|The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.|||||<|0.05||||||A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.|Mixed Models Analysis|||"All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment."||||<0.05
71871619|NCT03534284|143260869|SUPERIORITY|||||||0.6761||||||0.05 threshold for significance; no adjustment for multiple comparisons|Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 7||||0.6761
71871620|NCT03534284|143260870|SUPERIORITY|||||||0.8375|||||||Mixed Models Analysis|||Null hypothesis: average CBT-I=Trazodone=Placebo at week 25||||0.8375
71871621|NCT03316300|143260893|SUPERIORITY||Mean Difference (Final Values)|-0.091|STANDARD_ERROR_OF_MEAN|0.0176|<|0.0001|TWO_SIDED|95.0|-0.13|-0.06|||Mixed Models Analysis|||||-0.06|-0.13|<0.0001
71871622|NCT00557947|143260896|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|difference proportions of successes (%)|4.8||||0.2188|TWO_SIDED|95.0|0.0|10.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.|||10.9|-0.0|0.2188
71871623|NCT00557947|143260897|SUPERIORITY_OR_OTHER||||||<|0.0001||0.0|||||t-test, 2 sided|||||||<0.0001
71871624|NCT00557947|143260898|SUPERIORITY_OR_OTHER|||||||0.3877||0.0|||||McNemar|||||||0.3877
71871625|NCT00557947|143260899|SUPERIORITY_OR_OTHER|||||||0.7539||0.0|||||McNemar|||||||0.7539
71871626|NCT00557947|143260900|SUPERIORITY_OR_OTHER|||||||1||0.0|||||McNemar|||||||1.0000
71871627|NCT04737187|143260901|SUPERIORITY||Hazard Ratio (HR)|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.77||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|Overall Survival Median analysis: The primary estimand was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy).||0.77|0.49|< 0.001
71914795|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|1.2|STANDARD_ERROR_OF_MEAN|0.42||0.004|TWO_SIDED|95.0|0.38|2.02|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.02|0.38|0.004
71871628|NCT04737187|143260905|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.36|0.54||Stratified log-rank test, with a target p-value \< 0.025 for level of significance.|Stratified log-rank test||Hazard ratio and 95% confidence interval was estimated with stratified Cox proportional hazard model.|PFS Median analysis: A hierarchical testing method was used to control type I error and handle key secondary endpoint analysis. When the primary outcome measure significant testing was then performed sequentially on the key secondary outcome measure. statistically significant at 0.05 level.||0.54|0.36|< 0.001
71871629|NCT03756129|143260914|SUPERIORITY||Median Difference (Net)|-8.25||||0.0013|TWO_SIDED|80.0|-11.67|-4.83|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-4.83|-11.67|0.0013
71871630|NCT03756129|143260914|SUPERIORITY||Mean Difference (Net)|-5.71||||0.0196|TWO_SIDED|80.0|-9.22|-2.2|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo. The MIJ821 treatment arms vs placebo are primary."||-2.20|-9.22|0.0196
71871631|NCT03756129|143260915|SUPERIORITY||Mean Difference (Net)|-7.06||||0.013|TWO_SIDED|80.0|-11.06|-3.06|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.16 mg/kg minus placebo."||-3.06|-11.06|0.0130
71871632|NCT03756129|143260915|SUPERIORITY||Median Difference (Net)|-7.37||||0.0133|TWO_SIDED|80.0|-11.57|-3.18|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: Pooled MIJ821 0.32 mg/kg minus placebo."||-3.18|-11.57|0.0133
71871633|NCT03756129|143260916|SUPERIORITY||Mean Difference (Net)|-5.09||||0.1082|TWO_SIDED|80.0|-10.37|0.19|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg weekly minus placebo."||0.19|-10.37|0.1082
71871634|NCT03756129|143260916|SUPERIORITY||Mean Difference (Net)|-5.42||||0.0993|TWO_SIDED|80.0|-10.83|-0.02|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg weekly minus placebo."||-0.02|-10.83|0.0993
71871635|NCT03756129|143260916|SUPERIORITY||Mean Difference (Net)|-6.46||||0.0598|TWO_SIDED|80.0|-11.78|-1.15|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.16 mg/kg biweekly minus placebo."||-1.15|-11.78|0.0598
71871636|NCT03756129|143260916|SUPERIORITY||Mean Difference (Net)|-3.06||||0.2491|TWO_SIDED|80.0|-8.86|2.74|||ANCOVA|||"Comparison of adjusted arithmetic mean: Mean Difference: MIJ821 0.32 mg/kg biweekly minus placebo."||2.74|-8.86|0.2491
71871637|NCT01315353|143260933|SUPERIORITY|Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Cumulative rate difference|1.7|||||ONE_SIDED|95.0|-7.9||||||The lower bound of the (lower) one-sided 95% confidence interval was provided.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN2+ with 95% one-sided confidence interval.|||-7.9|
71871638|NCT01315353|143260934|OTHER|||||||0.94||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Log Rank|Log-rank test was stratified by ART use at screening.||Null Hypothesis: There is no difference between Arm A and Arm B with respect to time to CIN2+.||||0.94
71871639|NCT01315353|143260935|OTHER||Cumulative rate difference|4.4|||||TWO_SIDED|95.0|-4.8|13.6|||||Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN3+ with 95% two-sided confidence interval.||13.6|-4.8|
71871640|NCT01315353|143260936|OTHER|||||||0.445||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null hypothesis: There is no difference between Arm A and Arm B with respect to rate of premature study discontinuation.||||0.445
71871641|NCT01315353|143260937|OTHER|||||||1||||||P-value for the week 26 comparison. The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 26.||||1.000
71871642|NCT01315353|143260937|OTHER|||||||0.279||||||"P-value for the week 52 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between the Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 52.||||0.279
71871643|NCT01315353|143260937|OTHER|||||||0.781||||||"P-value for the week 78 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 78.||||0.781
71871644|NCT01315353|143260937|OTHER|||||||0.375||||||"P-value for the week 104 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 104.||||0.375
71871645|NCT01315353|143260937|OTHER|||||||0.444||||||"P-value for the week 130 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 130.||||0.444
71871646|NCT01315353|143260938|OTHER|||||||0.132||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.132
71871647|NCT01315353|143260939|OTHER|||||||0.227||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||0.227
71871648|NCT01315353|143260940|OTHER|||||||1||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.||||1.000
71871649|NCT03567434|143260943|SUPERIORITY|The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.283||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Frequency (Burst/Min)||||0.283
71871650|NCT03567434|143260943|SUPERIORITY|The original hypothesis was that resting MSNA burst incidence would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.92||||||The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||Statistical analysis on Burst Incidence (Burst/100hb)||||0.920
71914796|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.45||0.683|TWO_SIDED|95.0|-1.07|0.7|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.70|-1.07|0.683
71914797|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|1.21|STANDARD_ERROR_OF_MEAN|0.45||0.007|TWO_SIDED|95.0|0.33|2.09|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.09|0.33|0.007
71914798|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.45||0.687|TWO_SIDED|95.0|-0.71|1.07|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.07|-0.71|0.687
71871651|NCT03567434|143260945|SUPERIORITY|The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.||||||0.888||||||The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \< 0.05 was used for significance.|t-test, 2 sided|||||||0.888
71871652|NCT03035201|143260949|OTHER|two-tailed test of the null hypothesis of no differences between groups.|Mean from linear contrast|0.03|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|-0.02|0.08||Not adjusted|Mixed Models Analysis||Marginal effect of cocoa flavonal versus cocoa placebo based on the mean difference between linear contrasts.|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol.|0.08|-0.02|<0.05
71871653|NCT03035201|143260950|EQUIVALENCE|two-tailed test of the null hypothesis of no differences between groups.|Mean difference of linear contrasts|0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|0.02|0.12||Not adjusted|Wald test||Marginal effects of multivitamin versus multivitamin placebo|Marginal comparisons from a repeated measures model using a linear contrast to estimate the mean differences between baseline versus average values across follow-up.|Wald test of a linear contrast from the mixed effects analysis....see protocol|0.12|0.02|<0.05
71871654|NCT03035201|143260951|EQUIVALENCE|Proportional hazards regression -- unadjusted two-sided test|Hazard Ratio (HR)|0.76||||0.15|TWO_SIDED|95.0|0.52|1.11||Not adjusted|Regression, Cox||Comparison group is placebo|||1.11|0.52|0.15
71871655|NCT03035201|143260952|EQUIVALENCE|Unadjusted 2-sided test|Cox Proportional Hazard|0.91||||0.62|TWO_SIDED|95.0|0.63|1.32||Unadjusted|Regression, Cox||Comparison group is placebo.|||1.32|0.63|0.62
71871656|NCT03035201|143260953|EQUIVALENCE|Cocoa Flavonal minus Placebo|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.24|TWO_SIDED|95.0|-0.02|0.08||Unadjusted|Mixed Models Analysis|Wald test comparing linear contrasts|Cocoa Flavonal minus placebo|||0.08|-0.02|0.24
71871657|NCT03035201|143260954|EQUIVALENCE|two-sided|Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|95.0|-0.04|0.09||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts: cocoa flavonal minus placebo|Cocoa flavonal minus placebo|Unadjusted 2-tailed test||0.09|-0.04|0.41
71871658|NCT03035201|143260955|EQUIVALENCE|2 sided test, multivitamin minus placebo|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.02|TWO_SIDED|95.0|0.01|0.11||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|2-sided test, unadjusted||0.11|0.01|0.02
71871659|NCT03035201|143260956|EQUIVALENCE|2-sided, unadjusted|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.04|TWO_SIDED|95.0|0.002|0.126||Unadjusted|Mixed Models Analysis|Comparison of linear contrasts|Multivitamin minus placebo|Multivitamin minus placebo||0.126|0.002|0.04
71871660|NCT01880528|143260975|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||||||0.006
71871661|NCT01880528|143260976|SUPERIORITY|||||||0.0337|||||||Kruskal-Wallis|||||||0.0337
71871662|NCT01880528|143260977|SUPERIORITY|||||||0.0427|||||||Kruskal-Wallis|||||||0.0427
71871663|NCT01880528|143260978|SUPERIORITY|||||||0.0237|||||||Kruskal-Wallis|||||||0.0237
71871664|NCT01439360|143260979|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|63.2|||||TWO_SIDED|97.5|51.8|72.3|||Regression, Cox|Adjusted for age category and stratified for cohort.|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\>) 25%.||72.3|51.8|
71871665|NCT01439360|143260980|SUPERIORITY_OR_OTHER||Vaccine efficacy (VE)|49.8|||||TWO_SIDED|97.5|41.8|56.8|||Regression, Cox|Adjusted for age category and stratified for cohort|VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.||56.8|41.8|
71871666|NCT03727438|143261020|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-3.7|||<|0.01|TWO_SIDED|95.0|-5.0|-2.4||alpha=.05|Mixed Models Analysis|Model parameters included a common intercept (baseline means constrained to be equal), stratification variables, timepoint, and arm by timepoint.||"Analyses were conducted according to the intention-to-treat principle. All available data, including observations from participants who dropped out of the study, were used for primary and secondary analyses. Our modeling estimation approach was conducted with full-likelihood methods, providing unbiased treatment effect estimates under a missing-data framework known as missing at random (MAR)."||-2.4|-5.0|<0.01
71871667|NCT03727438|143261021|EQUIVALENCE|alpha= .05|Mean Difference (Final Values)|-19.6|||<|0.01|TWO_SIDED|95.0|-26.7|-12.5||alpha = 0.05|Mixed Models Analysis|||||-12.5|-26.7|<0.01
71871668|NCT03727438|143261022|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|-20.6|||<|0.01|TWO_SIDED|95.0|-29.1|-12.0||alpha = .05|Mixed Models Analysis|||||-12.0|-29.1|<0.01
71871669|NCT03727438|143261023|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|11.0|||<|0.01|TWO_SIDED|95.0|7.7|14.3|||Mixed Models Analysis|alpha = 0.05||||14.3|7.7|<0.01
71871670|NCT03727438|143261024|EQUIVALENCE|Alpha = .05|Mean Difference (Final Values)|-6.2|||>|0.05|TWO_SIDED|95.0|-12.5|0.1||Alpha = .05|Mixed Models Analysis|||||0.1|-12.5|> 0.05
71914799|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.89|STANDARD_ERROR_OF_MEAN|0.45||0.05|TWO_SIDED|95.0|0.0|1.78|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.78|-0.00|0.050
71914800|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.48||0.215|TWO_SIDED|95.0|-0.35|1.54|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.54|-0.35|0.215
71871671|NCT03727438|143261025|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.4|0.5||alpha =.05|Mixed Models Analysis|||||.5|-.4|>0.05
71871672|NCT03727438|143261026|EQUIVALENCE|alpha = .05|Mean Difference (Final Values)|1.5|||<|0.05|TWO_SIDED|95.0|0.2|2.9||alpha = .05|Mixed Models Analysis|||||2.9|0.2|<0.05
71683217|NCT01492101|142884685|EQUIVALENCE|\[3\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|2.1||||0.1656|TWO_SIDED|95.0|-0.88|5.14|||F-test|||||5.14|-0.88|0.1656
71871673|NCT01912456|143261027|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71871674|NCT01912456|143261027|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71871675|NCT01912456|143261027|OTHER||||||=|0.114|||||||Mixed Models Analysis|||||||= 0.114
71871676|NCT01912456|143261028|OTHER||difference in percentages of responder|13.8|||||TWO_SIDED|95.0|-2.8|29.7||||||||29.7|-2.8|
71871677|NCT01912456|143261029|OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||< 0.001
71871678|NCT01912456|143261029|OTHER||||||=|0.018|||||||Mixed Models Analysis|||||||= 0.018
71871679|NCT01912456|143261029|OTHER||||||=|0.31|||||||Mixed Models Analysis|||||||= 0.31
71871680|NCT01440374|143261044|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.202||||0.0315|TWO_SIDED|95.0|0.047|0.868|||Generalized Linear Mixed Models|||||0.868|0.047|0.0315
71871681|NCT00231153|143261062|SUPERIORITY_OR_OTHER||Net percentage difference|2.25||||0.082||95.0|-0.3|4.81||The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.|Cochran-Mantel-Haenszel|||Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.||4.81|-0.30|0.082
71871682|NCT00231153|143261063|SUPERIORITY_OR_OTHER||Net percentage difference|3.67||||0.002||95.0|1.4|5.93|||Cochran-Mantel-Haenszel|||||5.93|1.40|0.002
71871683|NCT00231153|143261064|SUPERIORITY_OR_OTHER||Net percentage difference|11.4|||<|0.001||95.0|6.7|16.11|||Cochran-Mantel-Haenszel|||||16.11|6.70|<0.001
71871684|NCT04487834|143261065|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71871685|NCT04487834|143261066|SUPERIORITY|||||||0.0001|||||||Fisher Exact|||||||0.0001
71871686|NCT04487834|143261067|SUPERIORITY|||||||0.4852|||||||Fisher Exact|||||||0.4852
71871687|NCT02647320|143261074|OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.157||0.755|TWO_SIDED|90.0|-0.211|0.309|||Mixed Model Repeated Measure|||Difference in change at week 12||0.309|-0.211|.755
71871688|NCT02647320|143261074|OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.161||0.512|TWO_SIDED|90.0|-0.16|0.371|||Mixed Model Repeated Measure|||Difference in change at week 12||0.371|-0.160|.512
71871689|NCT02647320|143261074|OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.14||0.566|TWO_SIDED|90.0|-0.312|0.151|||Mixed Model Repeated Measure|||Difference in change at week 12||0.151|-0.312|.566
71871690|NCT02647320|143261074|OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.139||0.002|TWO_SIDED|90.0|-0.655|-0.197|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.197|-0.655|.002
71871691|NCT02647320|143261075|OTHER||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|3.13||0.144|TWO_SIDED|90.0|-9.76|0.58|||Mixed Model Repeated Measure|||Difference in change at week 12||0.58|-9.76|.144
71871692|NCT02647320|143261075|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|3.16||0.773|TWO_SIDED|90.0|-6.14|4.31|||Mixed Model Repeated Measure|||Difference in change at week 12||4.31|-6.14|.773
71871693|NCT02647320|143261075|OTHER||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|2.79||0.963|TWO_SIDED|90.0|-4.73|4.48|||Mixed Model Repeated Measure|||Difference in change at week 12||4.48|-4.73|.963
71871694|NCT02647320|143261075|OTHER||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.74||0.258|TWO_SIDED|90.0|-7.64|1.42|||Mixed Model Repeated Measure|||Difference in change at week 12||1.42|-7.64|.258
71871695|NCT02647320|143261076|OTHER||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|5.5||0.228|TWO_SIDED|90.0|-15.74|2.43|||Mixed Model Repeated Measure|||Difference in change at week 12||2.43|-15.74|.228
71871696|NCT02647320|143261076|OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|5.51||0.894|TWO_SIDED|90.0|-8.36|9.84|||Mixed Model Repeated Measure|||Difference in change at week 12||9.84|-8.36|.894
71871697|NCT02647320|143261076|OTHER||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|4.86||0.846|TWO_SIDED|90.0|-8.97|7.08|||Mixed Model Repeated Measure|||Difference in change at week 12||7.08|-8.97|.846
71871698|NCT02647320|143261076|OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|4.77||0.409|TWO_SIDED|90.0|-11.82|3.93|||Mixed Model Repeated Measure|||Difference in change at week 12||3.93|-11.82|.409
71871699|NCT02647320|143261077|OTHER||LS Mean Difference|1.5|STANDARD_ERROR_OF_MEAN|2.59||0.576|TWO_SIDED|90.0|-2.83|5.73|||Mixed Model Repeated Measure|||Difference in change at week 12||5.73|-2.83|.576
71871700|NCT02647320|143261077|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|2.62||0.646|TWO_SIDED|90.0|-5.53|3.12|||Mixed Model Repeated Measure|||Difference in change at week 12||3.12|-5.53|.646
71871701|NCT02647320|143261077|OTHER||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|2.3||0.902|TWO_SIDED|90.0|-3.52|4.08|||Mixed Model Repeated Measure|||Difference in change at week 12||4.08|-3.52|.902
71871702|NCT02647320|143261077|OTHER||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|2.27||0.478|TWO_SIDED|90.0|-5.35|2.13|||Mixed Model Repeated Measure|||Difference in change at week 12||2.13|-5.35|.478
71871703|NCT02647320|143261078|OTHER||LS Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|4.22||0.072|TWO_SIDED|90.0|-14.57|-0.64|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.64|-14.57|.072
71871704|NCT02647320|143261078|OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|4.26||0.794|TWO_SIDED|90.0|-8.15|5.92|||Mixed Model Repeated Measure|||Difference in change at week 12||5.92|-8.15|.794
71871705|NCT02647320|143261078|OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|3.75||0.946|TWO_SIDED|90.0|-6.45|5.94|||Mixed Model Repeated Measure|||Difference in change at week 12||5.94|-6.45|.946
71871706|NCT02647320|143261078|OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|3.68||0.431|TWO_SIDED|90.0|-8.99|3.18|||Mixed Model Repeated Measure|||Difference in change at week 12||3.18|-8.99|.431
71871707|NCT02647320|143261079|OTHER||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|8.54||0.228|TWO_SIDED|90.0|-24.43|3.78|||Mixed Model Repeated Measure|||Difference in change at week 12||3.78|-24.43|.228
71871708|NCT02647320|143261079|OTHER||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|8.62||0.951|TWO_SIDED|90.0|-13.7|14.77|||Mixed Model Repeated Measure|||Difference in change at week 12||14.77|-13.70|.951
71871709|NCT02647320|143261079|OTHER||LS Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|7.59||0.852|TWO_SIDED|90.0|-13.96|11.13|||Mixed Model Repeated Measure|||Difference in change at week 12||11.13|-13.96|.852
71871710|NCT02647320|143261079|OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|7.45||0.608|TWO_SIDED|90.0|-16.13|8.48|||Mixed Model Repeated Measure|||Difference in change at week 12||8.48|-16.13|.608
71871711|NCT02647320|143261080|OTHER||LS Mean Difference|5.32|STANDARD_ERROR_OF_MEAN|15.289||0.728|TWO_SIDED|90.0|-19.932|30.566|||Mixed Model Repeated Measure|||Difference in change at week 4||30.566|-19.932|.728
71871712|NCT02647320|143261080|OTHER||LS Mean Difference|-3.27|STANDARD_ERROR_OF_MEAN|15.853||0.837|TWO_SIDED|90.0|-29.446|22.914|||Mixed Model Repeated Measure|||Difference in change at week 4||22.914|-29.446|.837
71871713|NCT02647320|143261080|OTHER||LS Mean Difference|-3.65|STANDARD_ERROR_OF_MEAN|13.747||0.791|TWO_SIDED|90.0|-26.352|19.051|||Mixed Model Repeated Measure|||Difference in change at week 4||19.051|-26.352|.791
71871714|NCT02647320|143261080|OTHER||LS Mean Difference|-40.03|STANDARD_ERROR_OF_MEAN|13.472||0.003|TWO_SIDED|90.0|-62.283|-17.787|||Mixed Model Repeated Measure|||Difference in change at week 4||-17.787|-62.283|.003
71871715|NCT02647320|143261081|OTHER||LS Mean Difference|4.39|STANDARD_ERROR_OF_MEAN|20.396||0.83|TWO_SIDED|90.0|-29.312|38.087|||Mixed Model Repeated Measure|||Difference in change at week 12||38.087|-29.312|.830
71871716|NCT02647320|143261081|OTHER||LS Mean Difference|24.25|STANDARD_ERROR_OF_MEAN|20.335||0.235|TWO_SIDED|90.0|-9.354|57.848|||Mixed Model Repeated Measure|||Difference in change at week 12||57.848|-9.354|.235
71871717|NCT02647320|143261081|OTHER||LS Mean Difference|17.25|STANDARD_ERROR_OF_MEAN|17.72||0.331|TWO_SIDED|90.0|-12.03|46.529|||Mixed Model Repeated Measure|||Difference in change at week 12||46.529|-12.030|.331
71871718|NCT02647320|143261081|OTHER||LS Mean Difference|-29.51|STANDARD_ERROR_OF_MEAN|17.393||0.091|TWO_SIDED|90.0|-58.254|-0.775|||Mixed Model Repeated Measure|||Difference in change at week 12||-0.775|-58.254|.091
71871719|NCT02647320|143261082|OTHER||LS Mean Difference|1.49|STANDARD_ERROR_OF_MEAN|9.28||0.873|TWO_SIDED|90.0|-13.835|16.815|||Mixed Model Repeated Measure|||Difference in change at week 4||16.815|-13.835|.873
71871720|NCT02647320|143261082|OTHER||LS Mean Difference|-8.09|STANDARD_ERROR_OF_MEAN|9.505||0.395|TWO_SIDED|90.0|-23.79|7.604|||Mixed Model Repeated Measure|||Difference in change at week 4||7.604|-23.790|.395
71871721|NCT02647320|143261082|OTHER||LS Mean Difference|-2.53|STANDARD_ERROR_OF_MEAN|8.306||0.761|TWO_SIDED|90.0|-16.247|11.185|||Mixed Model Repeated Measure|||Difference in change at week 4||11.185|-16.247|.761
71871722|NCT02647320|143261082|OTHER||LS Mean Difference|-27.73|STANDARD_ERROR_OF_MEAN|8.17|<|0.001|TWO_SIDED|90.0|-41.22|-14.236|||Mixed Model Repeated Measure|||Difference in change at week 4||-14.236|-41.220|<0.001
71871723|NCT02647320|143261083|OTHER||LS Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|12.001||0.527|TWO_SIDED|90.0|-27.441|12.221|||Mixed Model Repeated Measure|||Difference in change at week 12||12.221|-27.441|.527
71871724|NCT02647320|143261083|OTHER||LS Mean Difference|-7.39|STANDARD_ERROR_OF_MEAN|0.532||0.532|TWO_SIDED|90.0|-26.927|12.138|||Mixed Model Repeated Measure|||Difference in change at week 12||12.138|-26.927|.532
71871725|NCT02647320|143261083|OTHER||LS Mean Difference|-4.41|STANDARD_ERROR_OF_MEAN|10.421||0.672|TWO_SIDED|90.0|-21.635|12.807|||Mixed Model Repeated Measure|||Difference in change at week 12||12.807|-21.635|.672
71871726|NCT02647320|143261083|OTHER||LS Mean Difference|-31.58|STANDARD_ERROR_OF_MEAN|10.229||0.002|TWO_SIDED|90.0|-48.482|-14.676|||Mixed Model Repeated Measure|||Difference in change at week 12||-14.676|-48.482|.002
71871727|NCT02647320|143261084|OTHER||LS Mean Difference|-6.2|STANDARD_ERROR_OF_MEAN|5.9||0.298|TWO_SIDED|90.0|-15.9|3.6|||Mixed Model Repeated Measure|||Difference in change at week 2||3.60|-15.90|.298
71871728|NCT02647320|143261084|OTHER||LS Mean Difference|-16.3|STANDARD_ERROR_OF_MEAN|6.09||0.008|TWO_SIDED|90.0|-26.37|-6.27|||Mixed Model Repeated Measure|||Difference in change at week 2||-6.27|-26.37|.008
71871729|NCT02647320|143261084|OTHER||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|5.32||0.074|TWO_SIDED|90.0|-18.31|-0.75|||Mixed Model Repeated Measure|||Difference in change at week 2||-0.75|-18.31|.074
71871730|NCT02647320|143261084|OTHER||LS Mean Difference|-27.2|STANDARD_ERROR_OF_MEAN|5.32|<|0.001|TWO_SIDED|90.0|-35.96|-18.38|||Mixed Model Repeated Measure|||Difference in change at week 2||-18.38|-35.96|<0.001
71871731|NCT02647320|143261085|OTHER||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|5.96||0.84|TWO_SIDED|90.0|-11.04|8.63|||Mixed Model Repeated Measure|||Difference in change at week 4||8.63|-11.04|.840
71871732|NCT02647320|143261085|OTHER||LS Mean Difference|-11.9|STANDARD_ERROR_OF_MEAN|6.06||0.05|TWO_SIDED|90.0|-21.94|-1.91|||Mixed Model Repeated Measure|||Difference in change at week 4||-1.91|-21.94|.050
71871733|NCT02647320|143261085|OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.31||0.227|TWO_SIDED|90.0|-15.21|2.33|||Mixed Model Repeated Measure|||Difference in change at week 4||2.33|-15.21|.227
71871734|NCT02647320|143261085|OTHER||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|5.27||0.13|TWO_SIDED|90.0|-21.83|-4.43|||Mixed Model Repeated Measure|||Difference in change at week 4||-4.43|-21.83|0.13
71871735|NCT02647320|143261086|OTHER||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|6.55||0.642|TWO_SIDED|90.0|-7.77|13.88|||Mixed Model Repeated Measure|||Difference in change at week 8||13.88|-7.77|.642
71871736|NCT02647320|143261086|OTHER||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|6.72||0.512|TWO_SIDED|90.0|-15.52|6.68|||Mixed Model Repeated Measure|||Difference in change at week 8||6.68|-15.52|.512
71871737|NCT02647320|143261086|OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.81||0.486|TWO_SIDED|90.0|-13.66|5.54|||Mixed Model Repeated Measure|||Difference in change at week 8||5.54|-13.66|.486
71871738|NCT02647320|143261086|OTHER||LS Mean Difference|-16.7|STANDARD_ERROR_OF_MEAN|5.8||0.004|TWO_SIDED|90.0|-26.31|-7.16|||Mixed Model Repeated Measure|||Difference in change at week 8||-7.16|-26.31|.004
71871739|NCT02647320|143261087|OTHER||LS Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|8.11||0.285|TWO_SIDED|90.0|-22.09|4.7|||Mixed Model Repeated Measure|||Difference in change at week 12||4.70|-22.09|.285
71871740|NCT02647320|143261087|OTHER||LS Mean Difference|-18.6|STANDARD_ERROR_OF_MEAN|7.94||0.02|TWO_SIDED|90.0|-31.73|-5.49|||Mixed Model Repeated Measure|||Difference in change at week 12||-5.49|-31.73|.020
71871741|NCT02647320|143261087|OTHER||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|7.03||0.067|TWO_SIDED|90.0|-24.6|-1.35|||Mixed Model Repeated Measure|||Difference in change at week 12||-1.35|-24.60|.067
71871742|NCT02647320|143261087|OTHER||LS Mean Difference|-17.4|STANDARD_ERROR_OF_MEAN|6.88||0.012|TWO_SIDED|90.0|-28.76|-6.03|||Mixed Model Repeated Measure|||Difference in change at week 12||-6.03|-28.76|.012
71914801|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.96|STANDARD_ERROR_OF_MEAN|0.47||0.042|TWO_SIDED|95.0|0.03|1.89|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.89|0.03|0.042
71914802|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.5||0.401|TWO_SIDED|95.0|-1.41|0.56|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.41|0.401
71914803|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.5||0.98|TWO_SIDED|95.0|-0.96|0.99|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.99|-0.96|0.980
71871743|NCT00596427|143261089|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared.||||<0.01
71871744|NCT00596427|143261090|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||mixed-effects regression models|||Change from baseline between groups was compared.||||<0.001
71871745|NCT00596427|143261091|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|This model had fixed effects of treatment, visit and treatment by visit interaction and a random subject effect.||Comparison of change from baseline between groups (treatment effect)||||<0.1
71871746|NCT00596427|143261092|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||||||<0.01
71871747|NCT00596427|143261093|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||mixed-effects regression models|||||||<0.05
71871748|NCT00596427|143261094|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||Change from baseline between groups were compared (treatment effect)||||<0.1
71871749|NCT00596427|143261095|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||mixed-effects regression models|||||||0.05
71871750|NCT00596427|143261096|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||mixed-effects regression models|||||||0.6
71871751|NCT00596427|143261097|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||0.3
71871752|NCT00596427|143261098|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.0001
71871753|NCT00596427|143261099|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||mixed-effects regression models|||Treatment effect of change from baseline||||<0.01
71871754|NCT00596427|143261100|SUPERIORITY_OR_OTHER||||||<|0.1||95.0|||||mixed-effects regression models|||||||<0.1
71871755|NCT00320541|143261101|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||Statistical significance at 0.05 level was required.|Fisher Exact|||Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.||||0.117
71871756|NCT00320541|143261102|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||Log Rank|||||||0.247
71871757|NCT00320541|143261103|SUPERIORITY_OR_OTHER|||||||0.475||95.0|||||Log Rank|||||||0.475
71871758|NCT00320541|143261104|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.010
71871759|NCT00320541|143261105|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.119
71871760|NCT00320541|143261106|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.023
71871761|NCT00320541|143261107|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.002
71871762|NCT00320541|143261108|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.004
71871763|NCT00320541|143261109|SUPERIORITY_OR_OTHER|||||||0.067||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.067
71871764|NCT00320541|143261110|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.||||||0.036
71871765|NCT03057977|143261111|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.04|0.65|0.86|||Regression, Cox||Comparison vs. Placebo \[T/P\]|"Model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~alpha = 0.0496 (resulting from interim analysis) eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.86|0.65|<0.0001
71871766|NCT03057977|143261112|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Hazard Ratio (HR)|0.7||||0.0003|TWO_SIDED|95.04|0.58|0.85|||Joint frailty model||HR vs placebo of recurrent HFF|"Model accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.~eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction."||0.85|0.58|0.0003
71871767|NCT03057977|143261113|SUPERIORITY|H0: There is no difference between the effect of placebo and the effect of empagliflozin.|Treatment by time interaction|1.733|||<|0.0001|TWO_SIDED|99.9|0.669|2.796|||Random intercept random coef. model||Empa vs Placebo slope \[/year\]|"Random coefficient model allowing for random intercept and random slope per patient, with the same factors used for the primary endpoint (age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment) and additional factors time, treatment-by-time interaction, and baseline eGFR (CKD-EPI)cr-by-time interaction. Only on-treatment data from treated patients were used.~alpha=0.001"||2.796|0.669|<0.0001
71871768|NCT03057977|143261114|OTHER||Hazard Ratio (HR)|0.5||||0.0019|TWO_SIDED|95.0|0.32|0.77|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs. Placebo|||0.77|0.32|0.0019
71871769|NCT03057977|143261115|OTHER||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.81|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPK)cr, region, baseline diabetes status, sex, baseline LVEF, and treatment.|Comparison vs Placebo|||0.81|0.59|<0.0001
71914804|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.51||0.632|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.76|-1.25|0.632
71914805|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|1.08|STANDARD_ERROR_OF_MEAN|0.51||0.032|TWO_SIDED|95.0|0.09|2.07|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.07|0.09|0.032
71914806|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.54||0.668|TWO_SIDED|95.0|-1.29|0.83|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.83|-1.29|0.668
71871770|NCT03057977|143261116|OTHER||Hazard Ratio (HR)|0.92||||0.4133|TWO_SIDED|95.0|0.75|1.12|||Regression, Cox|Model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. Placebo|||1.12|0.75|0.4133
71871771|NCT03057977|143261117|OTHER||Hazard Ratio (HR)|0.92||||0.3536|TWO_SIDED|95.0|0.77|1.1|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CKD-EPI), region, baseline diabetes status, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.10|0.77|0.3536
71871772|NCT03057977|143261118|OTHER||Hazard Ratio (HR)|0.86||||0.3576|TWO_SIDED|95.0|0.62|1.19|||Regression, Cox|Cox regression model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline LVEF and treatment.|Comparison vs. placebo|||1.19|0.62|0.3576
71914807|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|1.11|STANDARD_ERROR_OF_MEAN|0.54||0.038|TWO_SIDED|95.0|0.06|2.16|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||2.16|0.06|0.038
71871773|NCT03057977|143261119|OTHER||Difference of adjusted means|2.06|STANDARD_ERROR_OF_MEAN|0.97||0.034|TWO_SIDED|95.0|0.16|3.96|||Mixed Model|Mixed model for repeated measures (MMRM)|Comparison vs. placebo|Mixed model with age, baseline eGFR (CKD-EPI) as linear covariate(s) and region, baseline diabetes status, sex, baseline LVEF, week reachable, treatment by visit interaction, baseline KCCQ - Clinical Summary Score by Visit interaction as fixed effects. An unstructured covariance structure has been used.||3.96|0.16|0.0340
71871774|NCT03057977|143261120|OTHER||Hazard Ratio (HR)|0.85||||0.0065|TWO_SIDED|95.0|0.75|0.95|||Joint frailty model||Comparison vs. placebo|Joint frailty model with terms for age, baseline eGFR (CDK-EPI), region, sex, baseline diabetes status and baseline LVEF. Model accounts for dependence between recurrent all-cause hospitalizations and all-cause mortality.||0.95|0.75|0.0065
71871775|NCT03435497|143261136|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.017|TWO_SIDED||||||Regression, Linear|||||||.017
71871776|NCT03435497|143261137|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.5||||0.05|TWO_SIDED|95.0|0.2|1.6|||Regression, Logistic|||||1.6|0.2|.05
71871777|NCT03435497|143261138|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
71871778|NCT03435497|143261139|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.012|TWO_SIDED||||||Regression, Linear|||||||0.012
71871779|NCT03435497|143261140|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical logistic repeated-measures regressions in which the response may have come from either follow-up, and the predictors were an indicator for study arm, the baseline value of the outcome, the follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Odds Ratio (OR)|10.0||||0.022|TWO_SIDED|95.0|1.5|67.7|||Regression, Logistic|||||67.7|1.5|0.022
71871780|NCT00120406|143261168|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is 10%.|||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|z-test, one-sided|||||||<0.01
71871781|NCT00120406|143261169|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||P-value has been adjusted for multiplicity.|Generalized estimating equation (GEE)|||||||<0.01
71871782|NCT03907410|143261201|SUPERIORITY||Mean Difference (Final Values)|15.0|||||TWO_SIDED|95.0|2.0|28.0||||||Multivariate comparison of Experiment phase adherence (Months 1-3) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||28|2|
71871783|NCT03907410|143261201|SUPERIORITY||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-20.0|7.0||||||Multivariate comparison of Observation phase adherence (Months 4-6) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.||7|-20|
71871784|NCT01468831|143261222|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|7.8|STANDARD_DEVIATION|7.4|||TWO_SIDED|95.0|-10.6|26.1|||||Difference = Minocycline - Placebo|||26.1|-10.6|
71871785|NCT01468831|143261223|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|1.1|STANDARD_DEVIATION|1.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871786|NCT01468831|143261224|OTHER||Mean Difference (Net)|-0.2|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.||||
71871787|NCT01468831|143261225|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|1.3|||TWO_SIDED|95.0|-3.9|2.3|||||Difference = Minocycline - Placebo|||2.3|-3.9|
71871788|NCT01468831|143261226|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-2.1|STANDARD_DEVIATION|1.0|||TWO_SIDED|95.0|-4.5|0.3|||||Difference = Minocycline - Placebo|||0.3|-4.5|
71871789|NCT01468831|143261227|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.8|||TWO_SIDED|95.0|-7.5|2.5|||||Difference = Minocycline - Placebo|||2.5|-7.5|
71871790|NCT01468831|143261228|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-3.5|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-9.4|2.4|||||Difference = Minocycline - Placebo|||2.4|-9.4|
71871791|NCT01468831|143261229|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-3.7|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-9.5|2.0|||||Difference = Minocycline - Placebo|||2|-9.5|
71871792|NCT01468831|143261230|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|5.8|STANDARD_DEVIATION|9.1|||TWO_SIDED|95.0|-17.1|28.6|||||Difference = Minocycline - Placebo|||28.6|-17.1|
71871793|NCT01468831|143261231|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-51.8|STANDARD_DEVIATION|70.8|||TWO_SIDED|95.0|-231.2|127.6|||||Difference = Minocycline - Placebo|||127.6|-231.2|
71871794|NCT01468831|143261232|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-45.5|STANDARD_DEVIATION|153.5|||TWO_SIDED|95.0|-522.6|431.6|||||Difference = Minocycline - Placebo|||431.6|-522.6|
71914808|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.53||0.868|TWO_SIDED|95.0|-1.13|0.95|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.95|-1.13|0.868
71914809|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.59|STANDARD_ERROR_OF_MEAN|0.52||0.257|TWO_SIDED|95.0|-0.43|1.62|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.62|-0.43|0.257
71914810|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|95.0|-1.0|1.15|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.15|-1.00|0.895
71914811|NCT00565812|143350952|SUPERIORITY_OR_OTHER||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|0.54||0.268|TWO_SIDED|95.0|-0.46|1.67|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.67|-0.46|0.268
71914812|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.44||0.908|TWO_SIDED|95.0|-0.92|0.82|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.82|-0.92|0.908
71914813|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.44||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.31|-2.05|0.008
71871795|NCT01468831|143261233|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-12.8|STANDARD_DEVIATION|163.8|||TWO_SIDED|95.0|-513.1|487.6|||||Difference = Minocycline - Placebo|||487.6|-513.1|
71871796|NCT01468831|143261234|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-9.5|STANDARD_DEVIATION|156.8|||TWO_SIDED|95.0|-487.0|468.0|||||Difference = Minocycline - Placebo|||468|-487|
71914814|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.46||0.44|TWO_SIDED|95.0|-1.25|0.54|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.54|-1.25|0.440
71914815|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.46||0.14|TWO_SIDED|95.0|-1.57|0.22|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.22|-1.57|0.140
71871797|NCT01468831|143261235|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871798|NCT01468831|143261236|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871799|NCT01468831|143261237|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871800|NCT01468831|143261237|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871801|NCT01468831|143261237|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|2.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871802|NCT01468831|143261238|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871803|NCT01468831|143261238|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871804|NCT01468831|143261238|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71871805|NCT01037244|143261240|SUPERIORITY_OR_OTHER||Difference in Least Square (LS) Means|5.04|||<|0.0001|TWO_SIDED|95.0|3.36|6.73|||ANCOVA|Baseline Domain Score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||6.73|3.36|<0.0001
71871806|NCT01037244|143261240|SUPERIORITY_OR_OTHER||Difference in LS Means|7.18|||<|0.0001|TWO_SIDED|95.0|5.49|8.86|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||8.86|5.49|<0.0001
71871807|NCT01037244|143261240|SUPERIORITY_OR_OTHER||Difference in LS Means|7.95|||<|0.0001|TWO_SIDED|95.0|6.27|9.63|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||9.63|6.27|<0.0001
71871808|NCT01037244|143261241|SUPERIORITY_OR_OTHER||Difference in LS Means|18.6|||<|0.0001|TWO_SIDED|95.0|11.72|25.48|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.48|11.72|<0.0001
71914816|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.46||0.474|TWO_SIDED|95.0|-0.58|1.24|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.24|-0.58|0.474
71914817|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.46||0.376|TWO_SIDED|95.0|-1.32|0.5|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.50|-1.32|0.376
71914818|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|0.66|STANDARD_ERROR_OF_MEAN|0.5||0.186|TWO_SIDED|95.0|-0.32|1.64|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||1.64|-0.32|0.186
71914819|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.5||0.185|TWO_SIDED|95.0|-1.63|0.32|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.32|-1.63|0.185
71914820|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.52||0.334|TWO_SIDED|95.0|-1.53|0.52|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.52|-1.53|0.334
71914821|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|0.52||0.055|TWO_SIDED|95.0|-2.0|0.02|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.02|-2.00|0.055
71914822|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.54||0.539|TWO_SIDED|95.0|-1.38|0.72|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.72|-1.38|0.539
71914823|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.53||0.018|TWO_SIDED|95.0|-2.3|-0.22|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.22|-2.30|0.018
71914824|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.53||0.365|TWO_SIDED|95.0|-1.52|0.56|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.56|-1.52|0.365
71914825|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.52||0.403|TWO_SIDED|95.0|-1.47|0.59|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.59|-1.47|0.403
71683218|NCT01492101|142884685|EQUIVALENCE|\[4\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Median Difference (Final Values)|0.5||||0.8356|TWO_SIDED|95.0|-3.9|4.82|||F-test|||||4.82|-3.9|0.8356
71683219|NCT01492101|142884685|EQUIVALENCE|\[5\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7727|TWO_SIDED|95.0|-2.88|3.88|||F-test|||||3.88|-2.88|0.7727
71914826|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.57||0.02|TWO_SIDED|95.0|-2.43|-0.21|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.21|-2.43|0.020
71914827|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-1.87|STANDARD_ERROR_OF_MEAN|0.56|<|0.001|TWO_SIDED|95.0|-2.98|-0.77|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.77|-2.98|<0.001
71914828|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.54||0.269|TWO_SIDED|95.0|-1.66|0.46|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.46|-1.66|0.269
71914829|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.54||0.104|TWO_SIDED|95.0|-1.92|0.18|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||0.18|-1.92|0.104
71914830|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.57||0.038|TWO_SIDED|95.0|-2.3|-0.06|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.06|-2.30|0.038
71914831|NCT00565812|143350953|SUPERIORITY_OR_OTHER||LS mean difference|-1.16|STANDARD_ERROR_OF_MEAN|0.57||0.041|TWO_SIDED|95.0|-2.28|-0.05|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.||-0.05|-2.28|0.041
71914832|NCT02667392|143350961|OTHER|||||||0.77||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.77
71914833|NCT02667392|143350962|OTHER|||||||0.61||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.61
71914834|NCT02667392|143350963|OTHER|||||||0.28||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.28
71914835|NCT02667392|143350964|OTHER|||||||0.002||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.002
71914836|NCT02667392|143350965|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
71914837|NCT02667392|143350966|OTHER|||||||0.03||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.03
71914838|NCT02667392|143350967|OTHER|||||||0.55||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.55
71914839|NCT02667392|143350968|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.0089|||||||t-test, 2 sided|||||||0.0089
71914840|NCT02667392|143350969|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.73|||||||t-test, 2 sided|||||||0.73
71914841|NCT02667392|143350970|OTHER|a priori threshold for statistical significance set at p \< 0.05||||||0.81|||||||t-test, 2 sided|||||||0.81
71914842|NCT02667392|143350971|OTHER|||||||0.02||||||a priori threshold for statistical significance set at p \< 0.05|t-test, 2 sided|||||||0.02
71914843|NCT02033850|143350972|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||Δs on ADL (baseline vs 6 months)||||.145
71914844|NCT02033850|143350972|SUPERIORITY|||||||0.618|||||||t-test, 2 sided|||Δs on ADL (6 vs 12 months)||||.618
71914845|NCT02033850|143350972|SUPERIORITY|||||||0.262|||||||t-test, 2 sided|||Δs on ADL (baseline vs 12 months)||||.262
71914846|NCT02033850|143350972|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Δs on IADL (baseline vs 6 months)||||.240
71914847|NCT02033850|143350972|SUPERIORITY|||||||0.134|||||||t-test, 2 sided|||Δs on IADL (6 vs 12 months)||||.134
71914848|NCT02033850|143350972|SUPERIORITY|||||||0.457|||||||t-test, 2 sided|||Δs on IADL (baseline vs 12 months)||||.457
71914849|NCT02033850|143350972|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||Δs on DAD (baseline vs 6 months)||||.612
71914850|NCT02033850|143350972|SUPERIORITY|||||||0.522|||||||t-test, 2 sided|||Δs on DAD (6 vs 12 months)||||.522
71914851|NCT02033850|143350972|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||Δs on DAD (baseline vs 12 months)||||.800
71914852|NCT02033850|143350973|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Δs on AQ (baseline vs 6 months)||||.204
71914853|NCT02033850|143350973|SUPERIORITY|||||||0.81|||||||t-test, 2 sided|||Δs on AQ (6 vs 12 months)||||.810
71914854|NCT02033850|143350973|SUPERIORITY|||||||0.193|||||||t-test, 2 sided|||Δs on AQ (baseline vs 12 months)||||.193
71871809|NCT01037244|143261241|SUPERIORITY_OR_OTHER||Difference in LS Means|29.02|||<|0.0001|TWO_SIDED|95.0|22.13|35.9|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||35.90|22.13|<0.0001
71871810|NCT01037244|143261241|SUPERIORITY_OR_OTHER||Difference in LS Means|31.51|||<|0.0001|TWO_SIDED|95.0|24.68|38.34|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||38.34|24.68|<0.0001
71871811|NCT01037244|143261242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
71871812|NCT01037244|143261242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
71871813|NCT01037244|143261242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
71871814|NCT01037244|143261242|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||||<0.0001
71871815|NCT01037244|143261243|SUPERIORITY_OR_OTHER||Difference in LS Means|0.44|||<|0.0001|TWO_SIDED|95.0|0.3|0.59|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.59|0.30|<0.0001
71871816|NCT01037244|143261243|SUPERIORITY_OR_OTHER||Difference in LS Means|0.68|||<|0.0001|TWO_SIDED|95.0|0.54|0.83|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.83|0.54|<0.0001
71871817|NCT01037244|143261243|SUPERIORITY_OR_OTHER||Difference in LS Means|0.8|||<|0.0001|TWO_SIDED|95.0|0.66|0.95|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.95|0.66|<0.0001
71871818|NCT01037244|143261244|SUPERIORITY_OR_OTHER||Difference in LS Means|16.67|||<|0.0001|TWO_SIDED|95.0|11.23|22.11|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||22.11|11.23|<0.0001
71871819|NCT01037244|143261244|SUPERIORITY_OR_OTHER||Difference in LS Means|22.57|||<|0.0001|TWO_SIDED|95.0|17.11|28.03|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||28.03|17.11|<0.0001
71914855|NCT02033850|143350973|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 6 months)||||.698
71914856|NCT02033850|143350973|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||Δs on EQ index (6 vs 12 months)||||.283
71914857|NCT02033850|143350973|SUPERIORITY|||||||0.647|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 12 months)||||.647
71871820|NCT01037244|143261244|SUPERIORITY_OR_OTHER||Difference in LS Means|28.39|||<|0.0001|TWO_SIDED|95.0|22.98|33.79|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||33.79|22.98|<0.0001
71871821|NCT01037244|143261245|SUPERIORITY_OR_OTHER||Difference in LS Means|1.89|||<|0.0001|TWO_SIDED|95.0|1.17|2.61|||ANCOVA|P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.61|1.17|<0.0001
71871822|NCT01037244|143261245|SUPERIORITY_OR_OTHER||Difference in LS Means|2.27|||<|0.0001|TWO_SIDED|95.0|1.54|2.99|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.99|1.54|<0.0001
71871823|NCT01037244|143261245|SUPERIORITY_OR_OTHER||Difference in LS Means|3.02|||<|0.0001|TWO_SIDED|95.0|2.3|3.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.73|2.30|<0.0001
71871824|NCT01037244|143261246|SUPERIORITY_OR_OTHER||Difference in LS Means|1.42|||<|0.0001|TWO_SIDED|95.0|0.81|2.03|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.03|0.81|<0.0001
71871825|NCT01037244|143261246|SUPERIORITY_OR_OTHER||Difference in LS Means|1.65|||<|0.0001|TWO_SIDED|95.0|1.04|2.26|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.26|1.04|<0.0001
71914858|NCT02033850|143350973|SUPERIORITY|||||||0.057|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 6 months)||||.057
71914859|NCT02033850|143350973|SUPERIORITY|||||||0.685|||||||t-test, 2 sided|||Δs on EQ visual (6 vs 12 months)||||.685
71914860|NCT02033850|143350973|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 12 months)||||.056
71914861|NCT02033850|143350973|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Δs on GDS (baseline vs 6 months)||||.393
71914862|NCT02033850|143350973|SUPERIORITY|||||||0.958|||||||t-test, 2 sided|||Δs on GDS (6 vs 12 months)||||.958
71914863|NCT02033850|143350973|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Δs on GDS (baseline vs 12 months)||||.448
71914864|NCT02033850|143350973|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on MCS (baseline vs 6 months)||||.567
71914865|NCT02033850|143350973|SUPERIORITY|||||||0.274|||||||t-test, 2 sided|||Δs on MCS (6 vs 12 months)||||.274
71914866|NCT02033850|143350973|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||Δs on MCS (baseline vs 12 months)||||.668
71914867|NCT02033850|143350973|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||Δs on PCS (baseline vs 6 months)||||.709
71914868|NCT02033850|143350973|SUPERIORITY|||||||0.567|||||||t-test, 2 sided|||Δs on PCS (6 vs 12 months)||||.567
71914869|NCT02033850|143350973|SUPERIORITY|||||||0.867|||||||t-test, 2 sided|||Δs on PCS (baseline vs 12 months)||||.867
71914870|NCT02033850|143350974|SUPERIORITY|||||||0.095|||||||Chi-squared|||MCS outcome (baseline vs 6 months)||||.095
71914871|NCT02033850|143350974|SUPERIORITY|||||||0.729|||||||Chi-squared|||MCS outcome (6 vs 12 months)||||.729
71914872|NCT02033850|143350974|SUPERIORITY|||||||0.115|||||||Chi-squared|||MCS outcome (baseline vs 12 months)||||.115
71914873|NCT02033850|143350974|SUPERIORITY|||||||0.576|||||||Chi-squared|||PCS outcome (baseline vs 6 months)||||.576
71914874|NCT02033850|143350974|SUPERIORITY|||||||0.191|||||||Chi-squared|||PCS outcome (6 vs 12 months)||||.191
71914875|NCT02033850|143350974|SUPERIORITY|||||||0.79|||||||Chi-squared|||PCS outcome (baseline vs 12 months)||||.790
71914876|NCT02033850|143350975|SUPERIORITY|||||||0.936|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 6 months)||||.936
71914877|NCT02033850|143350975|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||Δs on MoCA (6 vs 12 months)||||.188
71914878|NCT02033850|143350975|SUPERIORITY|||||||0.381|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 12 months)||||.381
71914879|NCT02033850|143350975|SUPERIORITY|||||||0.458|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 6 months)||||.458
71914880|NCT02033850|143350975|SUPERIORITY|||||||0.236|||||||t-test, 2 sided|||Δs on MMSE (6 vs 12 months)||||.236
71914881|NCT02033850|143350975|SUPERIORITY|||||||0.601|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 12 months)||||.601
71914882|NCT02033850|143350975|SUPERIORITY|||||||0.839|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 6 months)||||.839
71871826|NCT01037244|143261246|SUPERIORITY_OR_OTHER||Difference in LS Means|1.98|||<|0.0001|TWO_SIDED|95.0|1.37|2.59|||ANCOVA|P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.59|1.37|<0.0001
71871827|NCT01037244|143261247|SUPERIORITY_OR_OTHER||Difference in LS Means|0.57||||0.0019|TWO_SIDED|95.0|0.21|0.93|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||0.93|0.21|0.0019
71871828|NCT01037244|143261247|SUPERIORITY_OR_OTHER||Difference in LS Means|0.74|||<|0.0001|TWO_SIDED|95.0|0.38|1.1|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.10|0.38|<0.0001
71871829|NCT01037244|143261247|SUPERIORITY_OR_OTHER||Difference in LS Means|0.85|||<|0.0001|TWO_SIDED|95.0|0.49|1.21|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||1.21|0.49|<0.0001
71871830|NCT01037244|143261248|SUPERIORITY_OR_OTHER||Difference in LS Means|1.66|||<|0.0001|TWO_SIDED|95.0|1.13|2.19|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.19|1.13|<0.0001
71871831|NCT01037244|143261248|SUPERIORITY_OR_OTHER||Difference in LS Means|1.76|||<|0.0001|TWO_SIDED|95.0|1.23|2.29|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||2.29|1.23|<0.0001
71871832|NCT01037244|143261248|SUPERIORITY_OR_OTHER||Difference in LS Means|2.56|||<|0.0001|TWO_SIDED|95.0|2.03|3.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||3.09|2.03|<0.0001
71871833|NCT01037244|143261249|SUPERIORITY_OR_OTHER||Difference in LS Means|12.34|||<|0.0001|TWO_SIDED|95.0|7.29|17.4|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||17.40|7.29|<0.0001
71871834|NCT01037244|143261249|SUPERIORITY_OR_OTHER||Difference in LS Means|19.29|||<|0.0001|TWO_SIDED|95.0|14.23|24.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.36|14.23|<0.0001
71914883|NCT02033850|143350975|SUPERIORITY|||||||0.021|||||||t-test, 2 sided|||Δs on RAVL immediate (6 vs 12 months)||||.021
71914884|NCT02033850|143350975|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 12 months)||||.032
71914885|NCT02033850|143350975|SUPERIORITY|||||||0.858|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 6 months)||||.858
71914886|NCT02033850|143350975|SUPERIORITY|||||||0.212|||||||t-test, 2 sided|||Δs on RAVL recall (6 vs 12 months)||||.212
71914887|NCT02033850|143350975|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 12 months)||||.268
71914888|NCT02033850|143350975|SUPERIORITY|||||||0.184|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 6 months)||||.184
71914889|NCT02033850|143350975|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||Δs on ROCF recall (6 vs 12 months)||||.358
71914890|NCT02033850|143350975|SUPERIORITY|||||||0.768|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 12 months)||||.768
71871835|NCT01037244|143261249|SUPERIORITY_OR_OTHER||Difference in LS Means|19.16|||<|0.0001|TWO_SIDED|95.0|14.14|24.18|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled sites as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||24.18|14.14|<0.0001
71871836|NCT01037244|143261250|SUPERIORITY_OR_OTHER||Difference in LS Means|18.07|||<|0.0001|TWO_SIDED|95.0|10.7|25.43|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.43|10.70|<0.0001
71871837|NCT01037244|143261250|SUPERIORITY_OR_OTHER||Difference in LS Means|23.53|||<|0.0001|TWO_SIDED|95.0|16.12|30.94|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||30.94|16.12|<0.0001
71871838|NCT01037244|143261250|SUPERIORITY_OR_OTHER||Difference in LS Means|36.25|||<|0.0001|TWO_SIDED|95.0|28.92|43.59|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||43.59|28.92|<0.0001
71871839|NCT01037244|143261251|SUPERIORITY_OR_OTHER||Difference in LS Means|18.2|||<|0.0001|TWO_SIDED|95.0|10.79|25.6|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||25.60|10.79|<0.0001
71871840|NCT01037244|143261251|SUPERIORITY_OR_OTHER||Difference in LS Means|25.25|||<|0.0001|TWO_SIDED|95.0|17.82|32.69|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||32.69|17.82|<0.0001
71871841|NCT01037244|143261251|SUPERIORITY_OR_OTHER||Difference in LS Means|36.99|||<|0.0001|TWO_SIDED|95.0|29.63|44.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||44.36|29.63|<0.0001
71914891|NCT02033850|143350975|SUPERIORITY|||||||0.164|||||||t-test, 2 sided|||Δs on short story (baseline vs 6 months)||||.164
71914892|NCT02033850|143350975|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Δs on short story (6 vs 12 months)||||.420
71914893|NCT02033850|143350975|SUPERIORITY|||||||0.527|||||||t-test, 2 sided|||Δs on short story (baseline vs 12 months)||||.527
71914894|NCT02033850|143350975|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||Δs on visual search (baseline vs 6 months)||||.762
71914895|NCT02033850|143350975|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||Δs on visual search (6 vs 12 months)||||.405
71914896|NCT02033850|143350975|SUPERIORITY|||||||0.674|||||||t-test, 2 sided|||Δs on visual search (baseline vs 12 months)||||.674
71914897|NCT02033850|143350975|SUPERIORITY|||||||0.328|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 6 months)||||.328
71914898|NCT02033850|143350975|SUPERIORITY|||||||0.198|||||||t-test, 2 sided|||Δs on SDMT (6 vs 12 months)||||.198
71914899|NCT02033850|143350975|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 12 months)||||.639
71914900|NCT02033850|143350975|SUPERIORITY|||||||0.098|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 6 months)||||.098
71914901|NCT02033850|143350975|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||Δs on ROCF copy (6 vs 12 months)||||.235
71914902|NCT02033850|143350975|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 12 months)||||.789
71914903|NCT02033850|143350976|SUPERIORITY|||||||0.743|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 6 months)||||.743
71914904|NCT02033850|143350976|SUPERIORITY|||||||0.428|||||||t-test, 2 sided|||Δs on Stroop test (6 vs 12 months)||||.428
71914905|NCT02033850|143350976|SUPERIORITY|||||||0.294|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 12 months)||||.294
71914906|NCT02033850|143350976|SUPERIORITY|||||||0.157|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 6 months)||||.157
71914907|NCT02033850|143350976|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||Δs on TMT-A (6 vs 12 months)||||.094
71871842|NCT01037244|143261252|SUPERIORITY_OR_OTHER||Difference in LS Means|19.98|||<|0.0001|TWO_SIDED|95.0|12.69|27.26|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||27.26|12.69|<0.0001
71871843|NCT01037244|143261252|SUPERIORITY_OR_OTHER||Difference in LS Means|27.58|||<|0.0001|TWO_SIDED|95.0|20.29|34.88|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||34.88|20.29|<0.0001
71871844|NCT01037244|143261252|SUPERIORITY_OR_OTHER||Difference in LS Means|37.8|||<|0.0001|TWO_SIDED|95.0|30.57|45.03|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.||45.03|30.57|<0.0001
71871845|NCT00690820|143261253|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71871846|NCT00690820|143261254|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71871847|NCT00690820|143261255|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71871848|NCT00690820|143261256|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71871849|NCT00690820|143261257|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||<0.001
71871850|NCT00690820|143261258|SUPERIORITY_OR_OTHER|||||||0.671||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.671
71871851|NCT00690820|143261259|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.003
71871852|NCT00690820|143261260|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.||||0.023
71871853|NCT01249274|143261272|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.19||||0.01|TWO_SIDED|95.0|1.04|1.36|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is the risk ratio estimate for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for the treatment variable.|||1.36|1.04|0.010
71871854|NCT01249274|143261273|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|30.39||||0.003|TWO_SIDED|95.0|3.18|290.04|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||290.04|3.18|0.003
71871855|NCT01249274|143261273|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|16.65||||0.038|TWO_SIDED|95.0|1.18|235.52|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction term for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 and 3-month post-trial follow-up. Treatment variable reference group was progesterone.|Negative binomial distribution, log link, and first-order autoregressive covariance structure||235.52|1.18|0.038
71914908|NCT02033850|143350976|SUPERIORITY|||||||0.476|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 12 months)||||.476
71914909|NCT02033850|143350976|SUPERIORITY|||||||0.142|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 6 months)||||.142
71914910|NCT02033850|143350976|SUPERIORITY|||||||0.651|||||||t-test, 2 sided|||Δs on TMT-B (6 vs 12 months)||||.651
71914911|NCT02033850|143350976|SUPERIORITY|||||||0.534|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 12 months)||||.534
71914912|NCT02033850|143350977|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 6 months)||||.882
71914913|NCT02033850|143350977|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Δs on phonemic fluency (6 vs 12 months)||||.835
71914914|NCT02033850|143350977|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 12 months)||||.951
71914915|NCT02033850|143350977|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 6 months)||||.392
71914916|NCT02033850|143350977|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||Δs on semantic fluency (6 vs 12 months)||||.973
71914917|NCT02033850|143350977|SUPERIORITY|||||||0.486|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 12 months)||||.486
71914918|NCT02033850|143350978|SUPERIORITY|||||||0.92|||||||Chi-squared|||MoCA variations (baseline vs 6 months)||||.920
71871856|NCT01249274|143261274|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.99|TWO_SIDED|95.0|0.87|1.15|||Generalized Estimating Equation||Estimated value is the risk ratio for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for treatment.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||1.15|0.87|0.99
71871857|NCT01249274|143261275|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.34||||0.75|TWO_SIDED|95.0|0.23|7.88|||Generalized Estimating Equation||Estimated value is RR for treatment\*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p\<0.05) difference between groups if the effect size for the primary outcome was large.||7.88|0.23|0.75
71871858|NCT01249274|143261275|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.84|TWO_SIDED|95.0|0.24|5.84|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment\*time interaction for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 \& 3-month post-trial follow-up. Treatment variable reference group was progesterone.|||5.84|0.24|0.84
71871859|NCT01249274|143261276|SUPERIORITY_OR_OTHER|||||||0.103|TWO_SIDED||||||Fisher Exact|||||||0.1030
71871860|NCT01249274|143261277|SUPERIORITY_OR_OTHER||Score Statistic For Type 3 GEE Analysis|0.01||||0.9116|TWO_SIDED||||||Generalized Estimating Equation|Gamma distribution, logit link, 1st-order autoregressive covariance structure; p-value is for chi-sq (df=1) for type 3 GEE analysis score statistic|Estimated value is chi-sq (df=1) for type 3 GEE analysis score statistic for week\*treatment interaction term.|||||0.9116
71871861|NCT01249274|143261280|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|4.71||||0.048|TWO_SIDED|95.0|1.09|20.5|||Regression, Cox||Ratio presented is for placebo versus progesterone|||20.50|1.09|0.048
71914919|NCT02033850|143350978|SUPERIORITY|||||||0.17|||||||Chi-squared|||MoCA variations (6 vs 12 months)||||.170
71914920|NCT02033850|143350978|SUPERIORITY|||||||0.716|||||||Chi-squared|||MoCA variations (baseline vs 12 months)||||.716
71914921|NCT02033850|143350978|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (baseline vs 6 months)||||.973
71914922|NCT02033850|143350978|SUPERIORITY|||||||0.973|||||||Chi-squared|||MMSE variations (6 vs 12 months)||||.973
71871862|NCT01249274|143261281|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|3.5||||0.06|TWO_SIDED|95.0|0.92|13.3|||Regression, Cox||Ratio presented is for placebo versus progesterone|||13.30|0.92|0.06
71914923|NCT02033850|143350978|SUPERIORITY|||||||0.3|||||||Chi-squared|||MMSE variations (baseline vs 12 months)||||.300
71914924|NCT02033850|143350978|SUPERIORITY|||||||0.068|||||||Chi-squared|||RAVL immed. variations (baseline vs 6 months)||||.068
71914925|NCT02033850|143350978|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL immed. variations (6 vs 12 months)||||.089
71914926|NCT02033850|143350978|SUPERIORITY|||||||0.241|||||||Chi-squared|||RAVL immed. variations (baseline vs 12 months)||||.241
71914927|NCT02033850|143350978|SUPERIORITY|||||||0.089|||||||Chi-squared|||RAVL recall variations (baseline vs 6 months)||||.089
71914928|NCT02033850|143350978|SUPERIORITY|||||||0.17|||||||Chi-squared|||RAVL recall variations (6 vs 12 months)||||.170
71871863|NCT01498653|143261341|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|28.5|||<|0.001|TWO_SIDED|95.0|20.1|36.9|||ANCOVA|||||36.9|20.1|<0.001
71871864|NCT01708213|143261347|SUPERIORITY_OR_OTHER||Parametric Testing|0.05|||<|0.05|TWO_SIDED||||||Parametric testing|||||||<0.05
71871865|NCT04964414|143261363|SUPERIORITY|||||||0.6|||||||Paired t-test|||||||0.6
71871866|NCT04964414|143261364|SUPERIORITY|||||||0.6|||||||Wilcoxon signed-rank|||||||0.6
71871867|NCT04964414|143261365|SUPERIORITY|||||||0.09|||||||Paired t-test|||||||0.09
71871868|NCT04964414|143261370|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
71871869|NCT04964414|143261371|SUPERIORITY|||||||0.2|||||||Paired t-test|||||||0.2
71871870|NCT02656160|143261391|OTHER|||||||0.85||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||tonic||||0.85
71914929|NCT02033850|143350978|SUPERIORITY|||||||0.413|||||||Chi-squared|||RAVL recall variations (baseline vs 12 months)||||.413
71914930|NCT02033850|143350978|SUPERIORITY|||||||0.777|||||||Chi-squared|||ROCF recall variations (baseline vs 6 months)||||.777
71914931|NCT02033850|143350978|SUPERIORITY|||||||0.134|||||||Chi-squared|||ROCF recall variations (6 vs 12 months)||||.134
71914932|NCT02033850|143350978|SUPERIORITY|||||||0.498|||||||Chi-squared|||ROCF recall variations (baseline vs 12 months)||||.498
71914933|NCT02033850|143350978|SUPERIORITY|||||||0.942|||||||Chi-squared|||Short story variations (baseline vs 6 months)||||.942
71914934|NCT02033850|143350978|SUPERIORITY|||||||0.578|||||||Chi-squared|||Short story variations (6 vs 12 months)||||.578
71914935|NCT02033850|143350978|SUPERIORITY|||||||0.413|||||||Chi-squared|||Short story variations (baseline vs 12 months)||||.413
71914936|NCT02033850|143350978|SUPERIORITY|||||||1|||||||Chi-squared|||Visual search variations (baseline vs 6 months)||||1
71914937|NCT02033850|143350978|SUPERIORITY|||||||0.038|||||||Chi-squared|||Visual search variations (6 vs 12 months)||||.038
71914938|NCT02033850|143350978|SUPERIORITY|||||||0.658|||||||Chi-squared|||Visual search variations (baseline vs 12 months)||||.658
71914939|NCT02033850|143350978|SUPERIORITY|||||||0.522|||||||Chi-squared|||SDMT variations (baseline vs 6 months)||||.522
71914940|NCT02033850|143350978|SUPERIORITY|||||||0.674|||||||Chi-squared|||SDMT variations (6 vs 12 months)||||.674
71914941|NCT02033850|143350978|SUPERIORITY|||||||0.17|||||||Chi-squared|||SDMT variations (baseline vs 12 months)||||.170
71914942|NCT02033850|143350978|SUPERIORITY|||||||0.961|||||||Chi-squared|||Stroop test variations (baseline vs 6 months)||||.961
71914943|NCT02033850|143350978|SUPERIORITY|||||||0.413|||||||Chi-squared|||Stroop test variations (6 vs 12 months)||||.413
71914944|NCT02033850|143350978|SUPERIORITY|||||||0.477|||||||Chi-squared|||Stroop test variations (baseline vs 12 months)||||.477
71914945|NCT02033850|143350978|SUPERIORITY|||||||0.42|||||||Chi-squared|||TMT-A variations (baseline vs 6 months)||||.420
71914946|NCT02033850|143350978|SUPERIORITY|||||||0.241|||||||Chi-squared|||TMT-A variations (6 vs 12 months)||||.241
71914947|NCT02033850|143350978|SUPERIORITY|||||||0.295|||||||Chi-squared|||TMT-A variations (baseline vs 12 months)||||.295
71914948|NCT02033850|143350978|SUPERIORITY|||||||0.453|||||||Chi-squared|||TMT-B variations (baseline vs 6 months)||||.453
71914949|NCT02033850|143350978|SUPERIORITY|||||||0.952|||||||Chi-squared|||TMT-B variations (6 vs 12 months)||||.952
71871871|NCT02656160|143261391|OTHER|||||||0.322||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||Phasic activity||||0.322
71871872|NCT02656160|143261392|OTHER|||||||0.42||||||P\<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.42
71871873|NCT00446992|143261405|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||<0.001
71871874|NCT00446992|143261406|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||.043
71871875|NCT00446992|143261407|SUPERIORITY_OR_OTHER||||||=|0.69|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.690
71871876|NCT00446992|143261408|SUPERIORITY_OR_OTHER||||||=|0.691|TWO_SIDED||||||Intervariate|||Baseline compared to Week 16||||= 0.691
71871877|NCT00446992|143261409|SUPERIORITY_OR_OTHER||||||=|0.877|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.877
71871878|NCT00446992|143261410|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.003
71871879|NCT00446992|143261411|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= .005
71871880|NCT00446992|143261412|SUPERIORITY_OR_OTHER||||||=|0.696|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.696
71871881|NCT00446992|143261413|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Univariate linear regression|||Baseline compared to Week 16||||= 0.013
71871882|NCT02076178|143261414|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Fisher Exact|||Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir||||<0.01
71871883|NCT02434939|143261472|NON_INFERIORITY_OR_EQUIVALENCE|a clinically significant difference in validated pain scores was defined as 1.3. assuming both treatments are on average equal, 240 patients provided 95% power to demonstrate that IV low dose ketamine is non inferior to IV morphine with a 0.05 level of significance.|Mean Difference (Final Values)|5.5||||0.18|TWO_SIDED|95.0|-2.2|13.2|||t-test, 2 sided|||||13.2|-2.2|0.18
71871884|NCT02434939|143261475|NON_INFERIORITY_OR_EQUIVALENCE|A clinically meaningful difference in validated pain scores was defined as 1.3.Assuming both treatments are on average equal, a sample size of 240 patients (120 per group) provided 95% power to demonstrate that IV LDK is non-inferior to IV morphine with a 0.05 level of significance.||||||0.07|||||||t-test, 2 sided|||||||0.07
71871885|NCT00710021|143261476|SUPERIORITY_OR_OTHER|||||||0.53||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.53
71871886|NCT00710021|143261477|SUPERIORITY_OR_OTHER|||||||0.038||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.038
71871887|NCT00710021|143261478|SUPERIORITY_OR_OTHER|||||||0.047||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.047
71871888|NCT00710021|143261479|SUPERIORITY_OR_OTHER|||||||0.12||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.12
71871889|NCT00710021|143261480|SUPERIORITY_OR_OTHER|||||||0.31||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.31
71871890|NCT00710021|143261481|SUPERIORITY_OR_OTHER|||||||0.019||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.||||||0.019
71871891|NCT00710021|143261482|SUPERIORITY_OR_OTHER|||||||0.28||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.28
71871892|NCT00710021|143261483|SUPERIORITY_OR_OTHER|||||||0.05||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.||||||0.050
71871893|NCT00710021|143261484|SUPERIORITY_OR_OTHER|||||||0.29||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.29
71871894|NCT00710021|143261485|SUPERIORITY_OR_OTHER|||||||0.014||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.||||||0.014
71871895|NCT00710021|143261486|SUPERIORITY_OR_OTHER|||||||0.96||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.96
71871896|NCT00710021|143261487|SUPERIORITY_OR_OTHER|||||||0.67||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.||||||0.67
71871897|NCT00710021|143261488|SUPERIORITY_OR_OTHER|||||||0.59||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.59
71871898|NCT00710021|143261489|SUPERIORITY_OR_OTHER|||||||0.65||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.||||||0.65
71871899|NCT00710021|143261490|SUPERIORITY_OR_OTHER|||||||0.86||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||0.86
71871900|NCT00710021|143261491|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871901|NCT00710021|143261492|SUPERIORITY_OR_OTHER|||||||0.62||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.||||||0.62
71871902|NCT00710021|143261493|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871903|NCT00710021|143261494|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871904|NCT00710021|143261495|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871905|NCT00710021|143261496|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871906|NCT00710021|143261497|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871907|NCT00710021|143261498|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871908|NCT00710021|143261499|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871909|NCT00710021|143261500|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871910|NCT00710021|143261501|SUPERIORITY_OR_OTHER|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact|||||||1.0
71871911|NCT00710021|143261502|SUPERIORITY_OR_OTHER|||||||0.1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Cochran-Mantel-Haenszel|Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.||||||0.10
71871912|NCT01992393|143261536|OTHER|||||||0.036|||||||GEE|||||||0.036
71871913|NCT01992393|143261537|OTHER|||||||0.042|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.042
71871914|NCT01992393|143261537|OTHER|||||||0.204|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU||||0.204
71683220|NCT01492101|142884685|EQUIVALENCE|\[6\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.5||||0.7446|TWO_SIDED|95.0|-2.56|3.59|||F-test|||||3.59|-2.56|0.7446
71871915|NCT01992393|143261538|OTHER|||||||0.129|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.129
71871916|NCT01992393|143261538|OTHER|||||||0.978|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.978
71871917|NCT01992393|143261539|OTHER|||||||0.128|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.128
71871918|NCT01992393|143261539|OTHER|||||||0.015|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.015
71871919|NCT01992393|143261540|OTHER|||||||0.759|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.759
71871920|NCT01992393|143261540|OTHER|||||||0.471|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.471
71871921|NCT01992393|143261541|OTHER|||||||0.775|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.775
71871922|NCT01992393|143261541|OTHER|||||||0.433|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.433
71914950|NCT02033850|143350978|SUPERIORITY|||||||0.881|||||||Chi-squared|||TMT-B variations (baseline vs 12 months)||||.881
71871923|NCT01992393|143261542|OTHER|||||||0.936|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.936
71871924|NCT01992393|143261542|OTHER|||||||0.6|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 16 week between TIME and TAU.||||0.600
71871925|NCT01992393|143261543|OTHER|||||||0.56|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.560
71871926|NCT01992393|143261543|OTHER|||||||0.305|||||||t-test, 2 sided|||A two-sided two sample t-test comparing difference of values from baseline and 12 week between TIME and TAU.||||0.305
71871927|NCT04234425|143261558|OTHER|paired t test|Mean Difference (Final Values)|2.702|STANDARD_DEVIATION|5.36||0.017|TWO_SIDED||||||t-test, 2 sided|||||||.017
71871928|NCT04234425|143261559|OTHER|paired t test|Mean Difference (Final Values)|4.2|STANDARD_DEVIATION|7.06||0.08|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.08
71871929|NCT04234425|143261560|OTHER|paired t test|Mean Difference (Final Values)|20.47|STANDARD_DEVIATION|7.33||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
71871930|NCT03442985|143261562|OTHER||Risk Ratio (RR)|2.109||||0.2556|TWO_SIDED|95.0|0.583|7.638||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg versus (vs) Palovarotene 5.0 mg: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.638|0.583|0.2556
71871931|NCT03442985|143261562|OTHER||Risk Ratio (RR)|3.04||||0.1788|TWO_SIDED|95.0|0.601|15.373||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||15.373|0.601|0.1788
71914951|NCT02033850|143350978|SUPERIORITY|||||||0.413|||||||Chi-squared|||Phonemic fluency variations (baseline vs 6 months)||||.413
71914952|NCT02033850|143350978|SUPERIORITY|||||||0.961|||||||Chi-squared|||Phonemic fluency variations (6 vs 12 months)||||.961
71914953|NCT02033850|143350978|SUPERIORITY|||||||0.951|||||||Chi-squared|||Phonemic fluency variation (baseline vs 12 months)||||.951
71871932|NCT03442985|143261562|OTHER||Risk Ratio (RR)|1.441||||0.657|TWO_SIDED|95.0|0.287|7.234||The p-values were not adjusted for multiple testing due to small sample size.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new OCs was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||7.234|0.287|0.6570
71871933|NCT03442985|143261563|OTHER||Risk Ratio (RR)|-4412.6||||0.4252|TWO_SIDED|95.0|-15257.3|6432.1||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6432.1|-15257.3|0.4252
71871934|NCT03442985|143261563|OTHER||Risk Ratio (RR)|-4640.9||||0.4053|TWO_SIDED|95.0|-15570.8|6289.0||The p-values were not adjusted for multiple testing due to small sample size.|Unadjusted estimation equation model|||Palovarotene 2.5 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||6289.0|-15570.8|0.4053
71871935|NCT03442985|143261563|OTHER||Risk Ratio (RR)|-228.3||||0.9677|TWO_SIDED|95.0|-11265.0|10808.4||The p-values were not adjusted for multiple testings due to small sample size.|Unadjusted estimation equation model|||Palovarotene 5.0 mg vs Placebo: The mean difference in the change from baseline for total OC volume was estimated using an unadjusted estimation equation model with independent working covariance matrix to address potential correlation within the same family members.||10808.4|-11265.0|0.9677
71871936|NCT03442985|143261564|OTHER||Odds Ratio (OR)|0.643||||0.5025|TWO_SIDED|95.0|0.177|2.335|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.335|0.177|0.5025
71871937|NCT03442985|143261564|OTHER||Odds Ratio (OR)|0.528||||0.3763|TWO_SIDED|95.0|0.128|2.175|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||2.175|0.128|0.3763
71871938|NCT03442985|143261564|OTHER||Odds Ratio (OR)|0.82||||0.7714|TWO_SIDED|95.0|0.215|3.123|||Regression, Logistic|Logistic regression was adjusted for the following covariates: baseline age, sex, and Ext1/2 mutation status.||||3.123|0.215|0.7714
71871939|NCT03442985|143261565|OTHER||Risk Ratio (RR)|0.951||||0.8155|TWO_SIDED|95.0|0.623|1.451||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.451|0.623|0.8155
71871940|NCT03442985|143261565|OTHER||Risk Ratio (RR)|1.003||||0.9918|TWO_SIDED|95.0|0.592|1.699||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.699|0.592|0.9918
71871941|NCT03442985|143261565|OTHER||Risk Ratio (RR)|1.055||||0.7997|TWO_SIDED|95.0|0.7|1.589||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = compound symmetry was used.|Negative binomial regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of new or worsening deformities was estimated using an unadjusted negative binomial regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||1.589|0.700|0.7997
71871942|NCT03442985|143261566|OTHER||Risk Ratio (RR)|1.548||||0.2186|TWO_SIDED|95.0|0.772|3.108||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Palovarotene 5.0 mg: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||3.108|0.772|0.2186
71871943|NCT03442985|143261566|OTHER||Risk Ratio (RR)|1.655||||0.27|TWO_SIDED|95.0|0.676|4.052||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 2.5 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||4.052|0.676|0.2700
71871944|NCT03442985|143261566|OTHER||Risk Ratio (RR)|1.069||||0.8546|TWO_SIDED|95.0|0.524|2.178||The p-values were not adjusted for multiple testing due to small sample size. The correlation matrix type = independent was used.|Poisson regression model|||Palovarotene 5.0 mg vs Placebo: The annualized rate for number of MO-related surgeries was estimated using an unadjusted poisson regression model, offsetted by log-transformed follow-up time (years) to obtain annualized rate.||2.178|0.524|0.8546
71914954|NCT02033850|143350978|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variations (baseline vs 6 months)||||.951
71871945|NCT03645057|143261595|SUPERIORITY|||||||0.433|||||||Wilcoxon rank sum test|||||||0.433
71871946|NCT03645057|143261596|SUPERIORITY|||||||0.836|||||||Wilcoxon rank sum test|||||||0.836
71871947|NCT03645057|143261597|SUPERIORITY|||||||0.073|||||||Wilcoxon rank sum test|||||||0.073
71871948|NCT03645057|143261598|SUPERIORITY|||||||0.989|||||||Wilcoxon rank sum test|||||||0.989
71871949|NCT03645057|143261599|SUPERIORITY|||||||0.565|||||||Wilcoxon rank sum test|||||||0.565
71871950|NCT03645057|143261600|SUPERIORITY|||||||0.479|||||||Wilcoxon rank sum test|||||||0.479
71871951|NCT03645057|143261601|SUPERIORITY|||||||0.577|||||||Wilcoxon rank sum test|||||||0.577
71871952|NCT03645057|143261602|SUPERIORITY|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||||||0.439
71871953|NCT03645057|143261603|SUPERIORITY|||||||0.242|||||||Wilcoxon rank sum test|||||||0.242
71914955|NCT02033850|143350978|SUPERIORITY|||||||0.674|||||||Chi-squared|||Semantic fluency variations (6 vs 12 months)||||.674
71914956|NCT02033850|143350978|SUPERIORITY|||||||0.951|||||||Chi-squared|||Semantic fluency variation (baseline vs 12 months)||||.951
71914957|NCT02033850|143350978|SUPERIORITY|||||||1|||||||Chi-squared|||ROCF copy variations (baseline vs 6 months)||||1
71914958|NCT02033850|143350978|SUPERIORITY|||||||0.027|||||||Chi-squared|||ROCF copy variations (6 vs 12 months)||||.027
71871954|NCT01313637|143261627|SUPERIORITY_OR_OTHER||Least squares mean difference|0.16|||<|0.001|TWO_SIDED|95.0|0.122|0.198|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.198|0.122|<0.001
71871955|NCT01313637|143261627|SUPERIORITY_OR_OTHER||Least squares mean difference|0.124|||<|0.001|TWO_SIDED|95.0|0.086|0.162|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.162|0.086|<0.001
71871956|NCT01313637|143261627|SUPERIORITY_OR_OTHER||Least squares mean difference|0.238|||<|0.001|TWO_SIDED|95.0|0.2|0.276|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus Placebo.|||0.276|0.200|<0.001
71871957|NCT01313637|143261627|SUPERIORITY_OR_OTHER||Least squares mean difference|0.079|||<|0.001|TWO_SIDED|95.0|0.046|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus UMEC 125 µg.|||0.112|0.046|<0.001
71871958|NCT01313637|143261627|SUPERIORITY_OR_OTHER||Least squares mean difference|0.114|||<|0.001|TWO_SIDED|95.0|0.081|0.148|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus VI 25 µg.|||0.148|0.081|<0.001
71871959|NCT03339570|143261633|SUPERIORITY||Mean Difference (Final Values)|18.3|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||Student's t test was used if they were variables adjusted to a normal distribution, or the Mann-Whitney U test if they were non-normal variables.||||<0.01
71871960|NCT00679627|143261663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71871961|NCT00679627|143261664|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.011|TWO_SIDED|95.0|0.37|0.89|||Regression, Cox|||||0.89|0.37|0.011
71871962|NCT00679627|143261665|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71871963|NCT00679627|143261666|SUPERIORITY_OR_OTHER|||||||0.002|||||||ANCOVA|||||||0.002
71871964|NCT00679627|143261669|SUPERIORITY_OR_OTHER|||||||0.269||||||Baseline|Cochran-Mantel-Haenszel|||||||0.269
71871965|NCT00679627|143261669|SUPERIORITY_OR_OTHER|||||||0.835||||||Month 24|Cochran-Mantel-Haenszel|||||||0.835
71871966|NCT00679627|143261670|SUPERIORITY_OR_OTHER|||||||0.194||||||Orientation subscale|ANCOVA|||||||0.194
71871967|NCT00679627|143261670|SUPERIORITY_OR_OTHER|||||||0.353||||||Registration subscale|ANCOVA|||||||0.353
71914959|NCT02033850|143350978|SUPERIORITY|||||||0.169|||||||Chi-squared|||ROCF copy variations (baseline vs 12 months)||||.169
71871968|NCT00679627|143261670|SUPERIORITY_OR_OTHER|||||||0.009||||||Attention and Calculation subscale|ANCOVA|||||||0.009
71871969|NCT00679627|143261670|SUPERIORITY_OR_OTHER|||||||0.158||||||Recall subscale|ANCOVA|||||||0.158
71871970|NCT00679627|143261670|SUPERIORITY_OR_OTHER|||||||0.088||||||Language subscale|ANCOVA|||||||0.088
71914960|NCT02033850|143350979|SUPERIORITY|||||||0.478|||||||Chi-squared|||||||.478
71914961|NCT02033850|143350980|SUPERIORITY|||||||0.029||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in vermis VIIIb||||0.029
71914962|NCT02033850|143350980|SUPERIORITY|||||||0.04||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in right VIIb lobule||||0.04
71871971|NCT00679627|143261671|SUPERIORITY_OR_OTHER|||||||0.01||||||Initiation subscale|ANCOVA|||||||0.010
71871972|NCT00679627|143261671|SUPERIORITY_OR_OTHER|||||||0.043||||||Planning and Organization subscale|ANCOVA|||||||0.043
71871973|NCT00679627|143261671|SUPERIORITY_OR_OTHER|||||||0.018||||||Effective Performance subscale|ANCOVA|||||||0.018
71871974|NCT00679627|143261671|SUPERIORITY_OR_OTHER|||||||0.005||||||Basic subscale|ANCOVA|||||||0.005
71871975|NCT00679627|143261671|SUPERIORITY_OR_OTHER|||||||0.054||||||Instrumental subscale|ANCOVA|||||||0.054
71871976|NCT00679627|143261671|SUPERIORITY_OR_OTHER|||||||0.137||||||Leisure subscale|ANCOVA|||||||0.137
71871977|NCT01886378|143261672|SUPERIORITY||Least squares (LS) mean|423.594||||0.1518|TWO_SIDED|95.0|-155.66|1002.85||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% confidence interval (CI), and p-values are based on the GEE model.|||1002.85|-155.66|0.1518
71871978|NCT01886378|143261673|SUPERIORITY||LS mean|-0.011||||0.3964|TWO_SIDED|95.0|-0.04|0.01||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||0.01|-0.04|0.3964
71871979|NCT01886378|143261674|SUPERIORITY||LS mean|4.671||||0.0777|TWO_SIDED|95.0|-0.52|9.86||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||9.86|-0.52|0.0777
71871980|NCT01886378|143261675|SUPERIORITY||LS mean|181.37||||0.083|TWO_SIDED|95.0|-23.7|386.45||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||386.45|-23.70|0.0830
71871981|NCT01886378|143261676|SUPERIORITY||LS mean|-0.185||||0.032|TWO_SIDED|95.0|-0.35|-0.02||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||-0.02|-0.35|0.0320
71871982|NCT01886378|143261677|SUPERIORITY||LS mean|12.44||||0.085|TWO_SIDED|95.0|-1.72|26.6||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||26.60|-1.72|0.0850
71871983|NCT01886378|143261678|SUPERIORITY||LS mean|2.16||||0.3754|TWO_SIDED|95.0|-2.62|6.94||The LS Mean, standard error (SE), 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||6.94|-2.62|0.3754
71871984|NCT01886378|143261679|SUPERIORITY||LS mean|0.816||||0.7564|TWO_SIDED|95.0|-4.34|5.97||The LS Mean, SE, 95% CI, and 2-sided p-value are from the GEE model.|GEE model|||||5.97|-4.34|0.7564
71871985|NCT01886378|143261680|SUPERIORITY||LS mean|8.88|||<|0.0001|TWO_SIDED|95.0|5.67|12.08||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model|||||12.08|5.67|<0.0001
71871986|NCT01886378|143261681|SUPERIORITY||LS mean|9.7||||0.0152|TWO_SIDED|95.0|1.87|17.54||The GEE model included the change from Baseline for each parameter as the dependent variable, time as the categorical variable, and adjusted for Baseline measurement with compound symmetry covariance structure.|GEE model||LS Mean, 95% CI, and p-values are based on the GEE model.|||17.54|1.87|0.0152
71871987|NCT03021954|143261699|SUPERIORITY|||||||0.086|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is in the intervention group, we expect a decrease in the area of the levator hiatus at 40 days and 3 months post-partum. Power 90 % confidence interval β = 0.10, α = 0.05||||0.086
71871988|NCT03021954|143261700|EQUIVALENCE|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is platelet rich plasma can maintain or increase levator ani muscle contractions post-partum||||0.29
71871989|NCT02594826|143261729|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|35.8|||<|0.001|TWO_SIDED|95.0|11.1|114.9|||Mixed Models Analysis|This is the calculated p-value, which is adjusted for age, marital status, prior screening, health insurance, and having a healthcare provider.||||114.9|11.1|<0.001
71871990|NCT02594826|143261730|SUPERIORITY|||||||0.005|||||||Regression, Linear|Controlling for: marital status, education, language spoken at home, health insurance, regular physician, language of physician, ever had Pap test.||The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.||||0.005
71871991|NCT03581825|143261760|SUPERIORITY|Statistically superiority was concluded if the lower limit of the confidence intervals of the Test lens are greater than 40 points.|Least-Square Mean|56.3|STANDARD_ERROR_OF_MEAN|2.55|||TWO_SIDED|95.0|51.2|61.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.||||61.4|51.2|
71871992|NCT03581825|143261761|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control was concluded if the lower confidence limit of LSM difference was above the non-inferiority margin -5.|Least-Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|95.0|-0.5|7.4|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|Mean Difference was calculated as Test minus Control|||7.4|-0.5|
71871993|NCT01668667|143261762|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.57|STANDARD_ERROR_OF_MEAN|0.745||0.014|TWO_SIDED|95.0|-4.62|-0.52|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.52|-4.62|0.014
71871994|NCT01668667|143261762|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-2.61|STANDARD_ERROR_OF_MEAN|0.764||0.014|TWO_SIDED|95.0|-4.68|-0.54|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||-0.54|-4.68|0.014
71871995|NCT01668667|143261762|SUPERIORITY_OR_OTHER_LEGACY||Adjusted mean difference|-1.55|STANDARD_ERROR_OF_MEAN|0.767||0.144|TWO_SIDED|95.0|-3.63|0.53|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.||0.53|-3.63|0.144
71871996|NCT01668667|143261763|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.26||||0.004|TWO_SIDED|95.0|1.3|3.95|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.95|1.30|0.004
71871997|NCT01668667|143261763|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.007|TWO_SIDED|95.0|1.23|3.77|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.77|1.23|0.007
71871998|NCT01668667|143261763|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.24||||0.005|TWO_SIDED|95.0|1.27|3.94|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|"The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with much improved or very much improved on the investigator-rated CGI-I at the end of treatment."||3.94|1.27|0.005
71871999|NCT01668667|143261764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|TWO_SIDED||||||ANOVA|||For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.||||0.022
71872000|NCT01668667|143261764|SUPERIORITY_OR_OTHER_LEGACY|||||||0.072|TWO_SIDED||||||ANOVA|||Overall treatment effect||||0.072
71872001|NCT01668667|143261765|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.|Cochran-Armitage trend test|||||||0.012
71872002|NCT00511901|143261766|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.7||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.02
71872003|NCT00511901|143261767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||1||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 3 weeks||||1.00
71872004|NCT00511901|143261767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.3||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 8 weeks||||0.17
71872005|NCT00511901|143261767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 12 weeks||||0.59
71872006|NCT00511901|143261768|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.3||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
71872007|NCT00511901|143261769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 3 weeks||||0.66
71872008|NCT00511901|143261769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 8 weeks||||1.00
71872009|NCT00511901|143261769|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 12 weeks||||0.53
71872010|NCT00511901|143261770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 3 weeks||||0.96
71872011|NCT00511901|143261770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||1||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 8 weeks||||1.00
71872012|NCT00511901|143261770|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 12 weeks||||0.66
71872013|NCT00511901|143261771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.64||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 3 weeks||||0.64
71872014|NCT00511901|143261771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 8 weeks||||0.83
71872015|NCT00511901|143261771|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.1||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 12 weeks||||0.46
71872016|NCT00511901|143261772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.57||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 3 weeks||||0.37
71872017|NCT00511901|143261772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.39||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 8 weeks||||0.69
71872018|NCT00511901|143261772|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.15||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 12 weeks||||0.36
71914963|NCT02033850|143350980|SUPERIORITY|||||||0.039||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in left VIIb lobule||||0.039
71872019|NCT00511901|143261773|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.5||||0.97||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 3 weeks||||0.97
71872020|NCT00511901|143261773|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 8 weeks||||0.46
71872021|NCT00511901|143261773|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 12 weeks||||0.68
71872022|NCT00178126|143261774|SUPERIORITY_OR_OTHER|||||||0.04|||||||Fisher Exact|||||||0.04
71872023|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.1|1.78||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.78|1.10|
71872024|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.32||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.32|0.90|
71872025|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.13||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.13|1.19|
71872026|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.93|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.62|0.93|
71872027|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|12.1|||||TWO_SIDED|95.0|8.63|17.08||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||17.08|8.63|
71872028|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.82|3.48||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.48|1.82|
71872029|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.8|||||TWO_SIDED|95.0|1.98|3.87||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||3.87|1.98|
71872030|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.0|4.08||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||4.08|2.00|
71872031|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||TWO_SIDED|95.0|0.64|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.21|0.64|
71872032|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.39|2.51||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.51|1.39|
71914964|NCT02820038|143350981|SUPERIORITY||Odds Ratio (OR)|1.08||||0.8408|TWO_SIDED|95.0|0.52|2.24|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||2.24|0.52|0.8408
71914965|NCT02820038|143350981|SUPERIORITY||Odds Ratio (OR)|1.18||||0.58|TWO_SIDED|95.0|0.66|2.12|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or Other CMI+SMART, 1=DFB or DFB + SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.12|0.66|0.58
71914966|NCT02820038|143350981|SUPERIORITY||Odds Ratio (OR)|1.48||||0.1937|TWO_SIDED|95.0|0.82|2.68|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||2.68|0.82|0.1937
71914967|NCT02820038|143350981|SUPERIORITY||Odds Ratio (OR)|2.379||||0.0193|TWO_SIDED|95.0|1.15|4.92|||Regression, Logistic|Sample restricted to participants who did not meet the criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who did not meet criteria for informed decision-making at baseline.||4.92|1.15|0.0193
71914968|NCT02820038|143350981|SUPERIORITY||Odds Ratio (OR)|0.53||||0.2216|TWO_SIDED|95.0|0.19|1.48|||Regression, Logistic||Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who met the criteria for informed decision-making at baseline.||1.48|0.19|0.2216
71914969|NCT02820038|143350982|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.83|STANDARD_ERROR_OF_MEAN|1.32||0.163|TWO_SIDED|95.0|-1.83|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-1.83|0.1630
71914970|NCT02820038|143350982|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|1.05||0.7892|TWO_SIDED|95.0|-2.33|1.77|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.77|-2.33|0.7892
71914971|NCT02820038|143350982|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-2.19|STANDARD_ERROR_OF_MEAN|1.05||0.0377|TWO_SIDED|95.0|-4.25|-0.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||-0.13|-4.25|0.0377
71914972|NCT02820038|143350983|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.53||0.9216|TWO_SIDED|95.0|-0.98|1.08|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in values favorable to aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|1.08|-0.98|0.9216
71914973|NCT02820038|143350983|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.36|STANDARD_ERROR_OF_MEAN|0.42||0.3843|TWO_SIDED|95.0|-0.45|1.17|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.17|-0.45|0.3843
71872033|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.56|2.41||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||2.41|1.56|
71872034|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.72|1.28||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||1.28|0.72|
71872035|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.2|||||TWO_SIDED|95.0|3.67|7.33||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).||7.33|3.67|
71872036|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.08|1.73||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.73|1.08|
71872037|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.19|0.81|
71872038|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.07|1.77||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.77|1.07|
71872039|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4||||||95.0|1.01|1.8||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.80|1.01|
71872040|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.15||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.15|1.30|
71872041|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.24|2.12||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.24|
71872042|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.03|1.79||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.79|1.03|
71872043|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5||||||95.0|1.11|1.98||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.98|1.11|
71872044|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.16|2.12||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||2.12|1.16|
71872045|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||TWO_SIDED|95.0|0.86|1.47||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.47|0.86|
71872046|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||TWO_SIDED|95.0|1.16|1.69||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.69|1.16|
71872047|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||TWO_SIDED|95.0|0.87|1.54||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.54|0.87|
71872048|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.94|1.84||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.||1.84|0.94|
71872049|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.4|||||TWO_SIDED|95.0|2.03|2.87||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.87|2.03|
71872050|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||1.13|0.84|
71872051|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.92|2.76||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.76|1.92|
71872052|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.55|2.42||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.42|1.55|
71872053|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.84|2.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.67|1.84|
71872054|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.13|5.93||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.13|
71872055|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.41|3.49||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.49|2.41|
71872056|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|2.34|3.52||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.52|2.34|
71872057|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||TWO_SIDED|95.0|4.01|5.93||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.93|4.01|
71872058|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|1.91|2.79||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.79|1.91|
71872059|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||TWO_SIDED|95.0|2.02|2.66||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||2.66|2.02|
71872060|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.0|||||TWO_SIDED|95.0|2.44|3.6||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||3.60|2.44|
71872061|NCT00427895|143261788|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|3.31|5.31||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.||5.31|3.31|
71872062|NCT00427895|143261789|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|39.2|||||TWO_SIDED|95.0|33.0|45.1||||||||45.1|33.0|
71872063|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.4|||||TWO_SIDED|95.0|2.32|5.09||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||5.09|2.32|
71872064|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||TWO_SIDED|95.0|1.13|2.16||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.13|
71683221|NCT01492101|142884685|EQUIVALENCE|\[7\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.2||||0.9169|TWO_SIDED|95.0|-4.0|4.45|||F-test|||||4.45|-4.0|0.9169
71872065|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||TWO_SIDED|95.0|0.88|1.98||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.98|0.88|
71872066|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.2|||||TWO_SIDED|95.0|2.04|4.97||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.97|2.04|
71872067|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||TWO_SIDED|95.0|1.5|4.0||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.00|1.50|
71872068|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.7|||||TWO_SIDED|95.0|2.76|7.99||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||7.99|2.76|
71872069|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||TWO_SIDED|95.0|0.93|2.97||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.97|0.93|
71872070|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||TWO_SIDED|95.0|0.99|2.39||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.39|0.99|
71872071|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||TWO_SIDED|95.0|1.37|3.5||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.50|1.37|
71872072|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||TWO_SIDED|95.0|1.78|3.68||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.68|1.78|
71872073|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.77|4.01||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||4.01|1.77|
71872074|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.5|||||TWO_SIDED|95.0|1.99|6.13||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||6.13|1.99|
71872075|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||TWO_SIDED|95.0|2.87|6.08||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.08|2.87|
71872076|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.26|4.3||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.30|2.26|
71872077|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT ratio|2.6|||||TWO_SIDED|95.0|1.72|3.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.80|1.72|
71872078|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|6.5|||||TWO_SIDED|95.0|4.09|10.19||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.19|4.09|
71872079|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||TWO_SIDED|95.0|1.83|4.63||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.63|1.83|
71872080|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.8|||||TWO_SIDED|95.0|2.41|6.03||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.03|2.41|
71872081|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.8|||||TWO_SIDED|95.0|3.13|10.82||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||10.82|3.13|
71872082|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||TWO_SIDED|95.0|1.3|2.84||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.84|1.30|
71914974|NCT02820038|143350983|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.27|STANDARD_ERROR_OF_MEAN|0.42||0.509|TWO_SIDED|95.0|-0.54|1.09|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.09|-0.54|0.5090
71872083|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||TWO_SIDED|95.0|2.02|4.78||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||4.78|2.02|
71872084|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||TWO_SIDED|95.0|1.87|3.76||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.76|1.87|
71872085|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.4|||||TWO_SIDED|95.0|2.97|6.58||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||6.58|2.97|
71914975|NCT02820038|143350984|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.23||0.1486|TWO_SIDED|95.0|-0.77|0.12|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.12|-0.77|0.1486
71872086|NCT00427895|143261790|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.5|||||TWO_SIDED|95.0|3.2|9.41||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||9.41|3.20|
71872087|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|1.9|11.2||||||Serotype 1: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.2|1.9|
71872088|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.9|||||TWO_SIDED|95.0|-0.3|8.1||||||Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.1|-0.3|
71872089|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.4|||||TWO_SIDED|95.0|-0.2|7.2||||||Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-0.2|
71872090|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.3|||||TWO_SIDED|95.0|-2.6|7.2||||||Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|-2.6|
71872091|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|26.6|||||TWO_SIDED|95.0|21.7|31.7||||||Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||31.7|21.7|
71872092|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.5|||||TWO_SIDED|95.0|3.2|12.0||||||Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|3.2|
71872093|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|12.3|||||TWO_SIDED|95.0|7.3|17.4||||||Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||17.4|7.3|
71872094|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|14.1|||||TWO_SIDED|95.0|8.7|19.5||||||Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||19.5|8.7|
71872095|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.6|3.8||||||Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.8|-5.6|
71872096|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||TWO_SIDED|95.0|2.6|10.5||||||Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.5|2.6|
71872097|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.1|||||TWO_SIDED|95.0|1.2|7.1||||||Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.1|1.2|
71872098|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|-1.2|||||TWO_SIDED|95.0|-5.5|3.2||||||Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.||3.2|-5.5|
71872099|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|23.2|||||TWO_SIDED|95.0|17.0|29.3||||||Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||29.3|17.0|
71872100|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.6|||||TWO_SIDED|95.0|-0.2|7.5||||||Serotype 1: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.5|-0.2|
71872101|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-3.6|4.1||||||Serotype 3: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.1|-3.6|
71872102|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.4|||||TWO_SIDED|95.0|-0.4|5.5||||||Serotype 4: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.5|-0.4|
71914976|NCT02820038|143350984|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.18||0.4888|TWO_SIDED|95.0|-0.47|0.22|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.22|-0.47|0.4888
71914977|NCT02820038|143350984|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.18||0.8637|TWO_SIDED|95.0|-0.32|0.38|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.38|-0.32|0.8637
71914978|NCT02820038|143350985|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.25||0.507|TWO_SIDED|95.0|-0.33|0.66|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.66|-0.33|0.5070
71914979|NCT02820038|143350985|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.19||0.4821|TWO_SIDED|95.0|-0.25|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.25|0.4821
71914980|NCT02820038|143350985|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.2||0.7777|TWO_SIDED|95.0|-0.33|0.44|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.44|-0.33|0.7777
71914981|NCT02820038|143350986|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.64||0.6084|TWO_SIDED|95.0|-0.93|1.58|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.58|-0.93|0.6084
71914982|NCT02820038|143350986|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.5||0.597|TWO_SIDED|95.0|-0.71|1.23|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||1.23|-0.71|0.5970
71872103|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||TWO_SIDED|95.0|-5.8|3.9||||||Serotype 5: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.9|-5.8|
71872104|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.2|||||TWO_SIDED|95.0|-0.4|4.8||||||Serotype 6A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||4.8|-0.4|
71872105|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.0|||||TWO_SIDED|95.0|0.8|7.2||||||Serotype 6B: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.2|0.8|
71872106|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.4|||||TWO_SIDED|95.0|0.6|8.2||||||Serotype 7F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.2|0.6|
71872107|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.8|||||TWO_SIDED|95.0|-0.3|7.9||||||Serotype 9V: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||7.9|-0.3|
71872108|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Perecentage|4.2|||||TWO_SIDED|95.0|-0.1|8.7||||||Serotype 14: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||8.7|-0.1|
71872109|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-3.8|2.5||||||Serotype 18C: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||2.5|-3.8|
71872110|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.1|||||TWO_SIDED|95.0|-2.1|1.9||||||Serotype 19A: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||1.9|-2.1|
71872111|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.9|||||TWO_SIDED|95.0|-2.4|6.2||||||Serotype 19F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.2|-2.4|
71872112|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.5|||||TWO_SIDED|95.0|-4.7|5.7||||||Serotype 23F: Difference (cohort 2 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|-4.7|
71872113|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.2|||||TWO_SIDED|95.0|4.3|10.6||||||Serotype 1: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||10.6|4.3|
71872114|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.6|||||TWO_SIDED|95.0|-0.3|5.9||||||Serotype 3: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.9|-0.3|
71872115|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.2|||||TWO_SIDED|95.0|2.1|6.9||||||Serotype 4: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.9|2.1|
71872116|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|5.1|||||TWO_SIDED|95.0|1.4|9.1||||||Serotype 5: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.1|1.4|
71872117|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.7|||||TWO_SIDED|95.0|1.7|6.1||||||Serotype 6A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||6.1|1.7|
71914983|NCT02820038|143350986|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.5||0.5094|TWO_SIDED|95.0|-0.65|1.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.31|-0.65|.5094
71914984|NCT02820038|143350987|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.48|STANDARD_ERROR_OF_MEAN|2.74||0.5866|TWO_SIDED|95.0|-6.85|3.89|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.89|-6.85|0.5866
71914985|NCT02820038|143350987|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|2.13||0.8689|TWO_SIDED|95.0|-3.82|4.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.52|-3.82|0.8689
71914986|NCT02820038|143350987|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|2.14||0.4356|TWO_SIDED|95.0|-2.53|5.86|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.86|-2.53|.4356
71914987|NCT02820038|143350988|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.48|STANDARD_ERROR_OF_MEAN|2.95||0.2366|TWO_SIDED|95.0|-2.3|9.26|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in self-efficacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||9.26|-2.30|0.2366
71914988|NCT02820038|143350988|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|2.29||0.8841|TWO_SIDED|95.0|-4.16|4.83|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||4.83|-4.16|0.8841
71914989|NCT02820038|143350988|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.3||0.5264|TWO_SIDED|95.0|-3.05|5.95|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||5.95|-3.05|0.5264
71914990|NCT02820038|143350989|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|2.19||0.9604|TWO_SIDED|95.0|-4.4|4.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in medication adherence at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||4.18|-4.40|0.9604
71683222|NCT01492101|142884685|EQUIVALENCE|\[8\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.1||||0.9731|TWO_SIDED|95.0|-3.66|3.79|||F-test|||||3.79|-3.66|0.9731
71914991|NCT02820038|143350989|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-3.62|STANDARD_ERROR_OF_MEAN|1.64||0.0279|TWO_SIDED|95.0|-6.84|-0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in adherence between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||-0.40|-6.84|0.0279
71914992|NCT02820038|143350989|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.92|STANDARD_ERROR_OF_MEAN|1.66||0.0184|TWO_SIDED|95.0|0.67|7.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in medication adherence between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||7.18|0.67|0.0184
71914993|NCT02820038|143350990|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.73||0.3056|TWO_SIDED|95.0|-2.56|8.14|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in illness intrusiveness at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||8.14|-2.56|0.3056
71914994|NCT02820038|143350990|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|4.19|STANDARD_ERROR_OF_MEAN|2.11||0.0466|TWO_SIDED|95.0|0.06|8.32|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.32|0.06|0.0466
71914995|NCT02820038|143350990|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|2.11||0.9106|TWO_SIDED|95.0|-4.38|3.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.90|-4.38|0.9106
71872118|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.4|||||TWO_SIDED|95.0|4.1|9.3||||||Serotype 6B: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||9.3|4.1|
71872119|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.2|||||TWO_SIDED|95.0|5.4|11.6||||||Serotype 7F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.6|5.4|
71872120|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.8|||||TWO_SIDED|95.0|4.8|11.4||||||Serotype 9V: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||11.4|4.8|
71872121|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|11.2|||||TWO_SIDED|95.0|8.0|14.9||||||Serotype 14: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.9|8.0|
71872122|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.1|||||TWO_SIDED|95.0|0.9|5.7||||||Serotype 18C: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||5.7|0.9|
71872123|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.4|||||TWO_SIDED|95.0|0.3|3.1||||||Serotype 19A: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||3.1|0.3|
71872124|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.4|||||TWO_SIDED|95.0|5.4|12.0||||||Serotype 19F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||12.0|5.4|
71872125|NCT00427895|143261791|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|10.5|||||TWO_SIDED|95.0|6.8|14.7||||||Serotype 23F: Difference (cohort 3 - cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.||14.7|6.8|
71872126|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.31|||||TWO_SIDED|95.0|1.52|3.51||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.51|1.52|
71872127|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.37|||||TWO_SIDED|95.0|0.95|1.99||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.99|0.95|
71872128|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.32|||||TWO_SIDED|95.0|1.47|3.64||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.64|1.47|
71872129|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.4|||||TWO_SIDED|95.0|0.92|2.12||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.12|0.92|
71872130|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.47|||||TWO_SIDED|95.0|1.01|2.16||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.16|1.01|
71872131|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.67|1.59||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.67|
71872132|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.34|||||TWO_SIDED|95.0|0.94|1.92||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.92|0.94|
71872133|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.33|||||TWO_SIDED|95.0|0.8|2.23||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.23|0.80|
71872134|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.68|1.59||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.59|0.68|
71872135|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.15|||||TWO_SIDED|95.0|0.8|1.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||1.66|0.80|
71872136|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.79||||||95.0|1.07|3.0||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||3.00|1.07|
71872137|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.45|||||TWO_SIDED|95.0|0.95|2.24||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).||2.24|0.95|
71872138|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.18|||||TWO_SIDED|95.0|1.53|3.12||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.12|1.53|
71872139|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.06|1.91||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.91|1.06|
71872140|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.47|||||TWO_SIDED|95.0|1.71|3.55||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||3.55|1.71|
71872141|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.99|||||TWO_SIDED|95.0|1.45|2.74||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.74|1.45|
71872142|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.04|||||TWO_SIDED|95.0|1.5|2.76||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.76|1.50|
71872143|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.85|||||TWO_SIDED|95.0|1.32|2.58||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.58|1.32|
71872144|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.46|2.62||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.62|1.46|
71872145|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||TWO_SIDED|95.0|1.32|2.91||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.91|1.32|
71872146|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.36|||||TWO_SIDED|95.0|0.94|1.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||1.97|0.94|
71872147|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.08|2.03||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.03|1.08|
71872148|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|3.35|||||TWO_SIDED|95.0|2.19|5.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||5.12|2.19|
71872149|NCT00427895|143261793|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.0|||||TWO_SIDED|95.0|1.41|2.83||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).||2.83|1.41|
71872150|NCT00585195|143261819|SUPERIORITY||Ratio of adjusted geometric means|131.72|||||TWO_SIDED|90.0|96.59|179.63||||||||179.63|96.59|
71872151|NCT00585195|143261819|SUPERIORITY||Ratio of adjusted geometric means|239.03|||||TWO_SIDED|90.0|172.14|331.93||||||||331.93|172.14|
71872152|NCT00585195|143261819|SUPERIORITY||Ratio of adjusted geometric means|201.56|||||TWO_SIDED|90.0|139.33|291.58||||||||291.58|139.33|
71872153|NCT00585195|143261820|SUPERIORITY||Ratio of adjusted geometric means|216.19|||||TWO_SIDED|90.0|161.41|289.56||||||||289.56|161.41|
71872154|NCT00585195|143261820|SUPERIORITY||Ratio of adjusted geometric means|350.0|||||TWO_SIDED|90.0|141.09|868.23||||||||868.23|141.09|
71872155|NCT00585195|143261820|SUPERIORITY||Ratio of adjusted geometric means|365.43|||||TWO_SIDED|90.0|263.22|507.31||||||||507.31|263.22|
71872156|NCT00585195|143261823|SUPERIORITY||Ratio of adjusted geometric mean|15.57|||||TWO_SIDED|90.0|10.89|22.26||||||||22.26|10.89|
71872157|NCT00585195|143261824|SUPERIORITY||Ratio of adjusted geometric mean|20.64|||||TWO_SIDED|90.0|14.59|29.18||||||||29.18|14.59|
71872158|NCT00585195|143261826|SUPERIORITY||Ratio of adjusted geometric means|157.4|||||TWO_SIDED|90.0|136.89|180.97||||||||180.97|136.89|
71872159|NCT00585195|143261827|SUPERIORITY||Ratio of adjusted geometric means|132.81|||||TWO_SIDED|90.0|119.1|148.1||||||||148.10|119.10|
71872160|NCT00822523|143261884|SUPERIORITY_OR_OTHER|||||||0.61|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1||||0.61
71872161|NCT00822523|143261884|SUPERIORITY_OR_OTHER|||||||0.787|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2||||0.787
71872162|NCT00822523|143261884|SUPERIORITY_OR_OTHER|||||||0.234|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4||||0.234
71872163|NCT00822523|143261884|SUPERIORITY_OR_OTHER|||||||0.256|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14||||0.256
71872164|NCT00822523|143261884|SUPERIORITY_OR_OTHER|||||||0.292|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21||||0.292
71872165|NCT00822523|143261884|SUPERIORITY_OR_OTHER|||||||0.589|||||||t-test, 2 sided|||Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4||||0.589
71872166|NCT00822523|143261885|SUPERIORITY_OR_OTHER|||||||0.636|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurements||||0.636
71872167|NCT00822523|143261885|SUPERIORITY_OR_OTHER|||||||0.178|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment arm||||0.178
71872168|NCT00822523|143261886|SUPERIORITY_OR_OTHER|||||||0.995|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21||||0.995
71872169|NCT00822523|143261886|SUPERIORITY_OR_OTHER|||||||0.2088|||||||Repeated measure ANOVA|||"Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment arm"||||0.2088
71872170|NCT00822523|143261888|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
71872171|NCT00822523|143261888|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
71872172|NCT00822523|143261888|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
71872173|NCT00822523|143261890|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
71872174|NCT00822523|143261890|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
71872175|NCT00822523|143261890|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
71872176|NCT00822523|143261891|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
71872177|NCT00822523|143261891|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
71872178|NCT00822523|143261891|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
71872179|NCT00822523|143261892|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
71872180|NCT00822523|143261892|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
71872181|NCT00822523|143261892|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
71872182|NCT00822523|143261893|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
71872183|NCT00822523|143261893|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
71914996|NCT02820038|143350991|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1762|TWO_SIDED|95.0|-0.57|0.1|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group..|The investigators hypothesized that participants would exhibit greater decreases in health distress at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.10|-0.57|0.1762
71872184|NCT00822523|143261893|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
71872185|NCT00822523|143261894|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||0.0374
71872186|NCT00822523|143261894|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.188
71872187|NCT00822523|143261894|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
71872188|NCT00822523|143261895|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
71872189|NCT00822523|143261895|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
71872190|NCT00822523|143261895|SUPERIORITY_OR_OTHER||r value|0.8||||0.104|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.104
71872191|NCT00822523|143261896|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
71872192|NCT00822523|143261896|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
71872193|NCT00822523|143261896|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
71872194|NCT00822523|143261897|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
71872195|NCT00822523|143261897|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
71872196|NCT00822523|143261897|SUPERIORITY_OR_OTHER||r value|0.7||||0.188|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.188
71872197|NCT00822523|143261898|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
71872198|NCT00822523|143261898|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
71872199|NCT00822523|143261898|SUPERIORITY_OR_OTHER||r value|0.5||||0.391|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.391
71872200|NCT00822523|143261899|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
71872201|NCT00822523|143261899|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
71872202|NCT00822523|143261899|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.0374
71872203|NCT00822523|143261900|SUPERIORITY_OR_OTHER||r value|0.99|||<|0.0001|TWO_SIDED||||||Spearman Correlation Test|||Day 4||||<0.0001
71872204|NCT00822523|143261900|SUPERIORITY_OR_OTHER||r value|0.9||||0.0374|TWO_SIDED||||||Spearman Correlation Test|||Day 14||||0.0374
71872205|NCT00822523|143261900|SUPERIORITY_OR_OTHER||r value|0.4||||0.505|TWO_SIDED||||||Spearman Correlation Test|||Month 4||||0.505
71872206|NCT02881957|143262026|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||Two-sided t-test evaluated comparing length of stay in vitamin D3 vs. placebo treated patients utilizing patients as randomized (e.g., intent-to-treat) using a p\<0.05 as significant. Adverse events were monitored until discharge.||||0.2
71872207|NCT02881957|143262027|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.4
71872208|NCT02881957|143262028|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||||||0.3
71872209|NCT02881957|143262029|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
71872210|NCT02881957|143262030|SUPERIORITY|||||||0.7|||||||Chi-squared|||||||0.7
71872211|NCT02881957|143262031|SUPERIORITY|||||||0.99|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.99
71872212|NCT02881957|143262032|SUPERIORITY|||||||0.6|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.6
71872213|NCT02881957|143262033|SUPERIORITY|||||||0.7|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.7
71872214|NCT02881957|143262034|SUPERIORITY|||||||0.4|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.4
71872215|NCT02881957|143262035|SUPERIORITY|||||||0.1|||||||Chi-squared|||Adverse events were monitored until patient discharge from the hospital.||||0.1
71872216|NCT00081497|143262036|SUPERIORITY_OR_OTHER||Change in Slope Mean|-0.029||||0.013||95.0|-0.051|-0.007|||Mixed Models Analysis|Mixed effects model with a population level (fixed effect) intercept and slope and a subject level (random effect) intercept and slope.||The statistical analysis represents the primary outcome measure results.||-0.007|-0.051|0.0130
71872217|NCT00081497|143262037|SUPERIORITY_OR_OTHER||Mean Difference|-6.787||||0.0027||95.0|-11.123|-2.45|||Mixed Effects Model|||Statistical Analysis 1 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup \>60.||-2.450|-11.123|0.0027
71872218|NCT00081497|143262037|SUPERIORITY_OR_OTHER||Mean Difference|2.33||||0.1268||95.0|-0.685|5.345|||Mixed Effects Model|||Statistical Analysis 2 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup ≤ 60.||5.345|-0.685|0.1268
71872219|NCT01786174|143262071|SUPERIORITY_OR_OTHER||Slope|1.4|STANDARD_ERROR_OF_MEAN|4.3||0.746|TWO_SIDED|95.0|-7.17|9.96|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||9.96|-7.17|0.746
71872220|NCT01786174|143262072|SUPERIORITY_OR_OTHER||Slope|0.25|STANDARD_ERROR_OF_MEAN|0.89||0.78|TWO_SIDED|95.0|-1.53|2.03|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||2.03|-1.53|0.780
71872221|NCT01786174|143262073|SUPERIORITY_OR_OTHER||Slope|-0.51|STANDARD_ERROR_OF_MEAN|2.26||0.823|TWO_SIDED|95.0|-5.0|3.99|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||3.99|-5.00|0.823
71872222|NCT01786174|143262075|SUPERIORITY_OR_OTHER||Slope|4.27|STANDARD_ERROR_OF_MEAN|4.04||0.294|TWO_SIDED|95.0|-3.78|12.33|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4||12.33|-3.78|0.294
71872223|NCT04281004|143262080|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71872224|NCT04281004|143262081|SUPERIORITY|||||||0.869|||||||Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.869
71872225|NCT04281004|143262082|SUPERIORITY|||||||0.007||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.007
71872226|NCT04281004|143262082|SUPERIORITY|||||||0.953||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.953
71872227|NCT04281004|143262082|SUPERIORITY|||||||0.841||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.841
71872228|NCT04281004|143262082|SUPERIORITY|||||||0.137||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.137
71872229|NCT04281004|143262083|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
71872230|NCT04281004|143262084|SUPERIORITY|||||||0.594|||||||Fisher Exact|||||||0.594
71872231|NCT04281004|143262085|SUPERIORITY|||||||0.663||||||Significance of treatment effect at month 1.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.663
71872232|NCT04281004|143262085|SUPERIORITY|||||||0.416||||||Significance of treatment effect at month 3.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.416
71872233|NCT04281004|143262085|SUPERIORITY|||||||0.89||||||Significance of treatment effect at month 6.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.890
71872234|NCT04281004|143262085|SUPERIORITY|||||||0.192||||||Significance of treatment effect at month 12.|Wilcoxon (Mann-Whitney)|Clustered version of the Wilcoxon test||||||0.192
71872235|NCT04281004|143262086|SUPERIORITY|||||||0.057||||||Significance of treatment effect at month 1.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.057
71872236|NCT04281004|143262086|SUPERIORITY|||||||0.528||||||Significance of treatment effect at month 3.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.528
71872237|NCT04281004|143262086|SUPERIORITY|||||||0.21||||||Significance of treatment effect at month 6.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.210
71872238|NCT04281004|143262086|SUPERIORITY|||||||0.853||||||Significance of treatment effect at month 12.|Mixed Models Analysis|Mixed model analysis is used to account for correlation between eyes in the same participant.||||||0.853
71872239|NCT02482870|143262090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.119|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared|Chi-square value = 2.424; degrees of freedom = 1||Sample size was calculated according to the first 60 patients. To obtain 90% power with an alpha error of 0.05, a total of 378 patients were required. Considering a possible drop-out rate of 2.5% due to unexpected complications, we aimed for 388 patients.||||0.119
71872240|NCT02482870|143262091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.8|||<|0.0001|TWO_SIDED|95.0|3.0|4.6||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||4.6|3|<0.0001
71872241|NCT02482870|143262092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.9|||<|0.0001|TWO_SIDED|95.0|0.5|1.4||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||||1.4|0.5|<0.0001
71872242|NCT02482870|143262093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.67||A priori threshold for statistical significance was 0.05.|t-test, 2 sided|t value = -11.224, degrees of freedom = 773.99||"For each patient, the difference between Cormack-Lehane score and Mallampati class was calculated for each laryngoscope. As an example, the first patient had a Mallampati score 3. Macintosh laryngoscope provided a Cormack-Lehane score of 2, therefore the difference is - 1, calculated as 2 - 3. In the same patient, King Vision video laryngoscope provided a Cormack-Lehane score of 1, therefore the difference is - 2, calculated as 1 - 3. T-test was used to compare the differences."||-0.67|-0.95|<0.0001
71872243|NCT02482870|143262094|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED|||||A priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-square test with Yates' continuity correction: chi-square = 0.101; degrees of freedom = 1||||||0.75
71872244|NCT01337115|143262144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.44|STANDARD_ERROR_OF_MEAN|8.4||0.001|TWO_SIDED|95.0|11.55|45.34|||t-test, 2 sided|||Difference between mean VAS pain scores. Power 80%. Null hypothesis states there is no difference between pains scores in both groups||45.34|11.55|0.001
71872245|NCT01337115|143262145|SUPERIORITY_OR_OTHER|||||||0.537||||||The null hypothesis is that there is no difference in patient satisfaction distribution by the three categories used (Bad; Reasonable; Good/Very Good) between groups.|Fisher's exact test|Fisher's Exact test allows to test for the significance of the distribution in the results table with three categories.||||||0.537
71872246|NCT01337115|143262146|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|16.92|STANDARD_ERROR_OF_MEAN|5.67||0.006|TWO_SIDED|95.0|5.52|28.33|||t-test, 2 sided|||Null hypothesis states that there is no difference between groups. Power 80%||28.33|5.52|0.006
71872247|NCT01337115|143262147|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.55|STANDARD_ERROR_OF_MEAN|7.14||0.723|TWO_SIDED|95.0|-16.93|11.83|||t-test, 2 sided|||Null hypothesis states there is no difference between both groups. Power 80% to detect 15% difference in means||11.83|-16.93|0.723
71872248|NCT03513588|143262199|OTHER||Least Squares Mean Difference|-24.34|||<|0.001|TWO_SIDED|80.0|-31.28|-16.7|||ANCOVA|||||-16.70|-31.28|<0.001
71872249|NCT03513588|143262199|OTHER||Least Squares Mean Difference|-33.91|||<|0.001|TWO_SIDED|80.0|-39.78|-27.47|||ANCOVA|||||-27.47|-39.78|<0.001
71872250|NCT01054846|143262267|SUPERIORITY_OR_OTHER||z value|2.696|||<|0.01|TWO_SIDED||||||Chi-squared|||Differences between Survey 1 and Survey 2||||<0.01
71872251|NCT01054846|143262267|SUPERIORITY_OR_OTHER||z value|1.351|||>|0.05|TWO_SIDED||||||Chi-squared|||Difference between Survey 1 and Survey 2||||>0.05
71872252|NCT02446886|143262269|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.04|TWO_SIDED||||||t-test, 2 sided|||Previously published reproducibility of our MWF imaging (FAST-T2) has been established to be +/- 2.0 Our hypothesis for this study was the monthly ACTH would lead to greater remylination in acute MS lesions. However, to reach this goal, improvement must be beyond established reproducibility. Note: Since MWF is a fraction of myelin water to total water, it does not have a unit.||||0.04
71872253|NCT02446886|143262274|SUPERIORITY||Mean Difference (Final Values)|1.65||||0.077|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were implemented to assess the variables of interest (lesion MWF) among patients randomized to once versus the monthly ACTH treatment group. The modeling strategy accounts for multiple lesions per patient, repeated measurements (longitudinal analysis) and the following covariates were always considered: patient age, gender, disease duration, individual T2w lesion volume, time on disease modifying treatments (DMT) prior to enrollment, and DMT during the study.|Linear mixed-effects models were implemented|||0.077
71872254|NCT02988622|143262276|SUPERIORITY||Mean Difference (Net)|0.1205|STANDARD_DEVIATION|0.5499||0.0492|TWO_SIDED||||||t-test, 2 sided|||||||0.0492
71872255|NCT02988622|143262277|SUPERIORITY||Mean Difference (Net)|0.241|STANDARD_DEVIATION|0.0817||0.0817|TWO_SIDED||||||t-test, 2 sided|||||||0.0817
71872256|NCT02988622|143262278|SUPERIORITY||Mean Difference (Net)|0.3659|STANDARD_DEVIATION|1.7951||0.0686|TWO_SIDED||||||t-test, 2 sided|||||||0.0686
71872257|NCT02988622|143262279|SUPERIORITY||Mean Difference (Net)|-0.0843|STANDARD_DEVIATION|1.5789||0.6278|TWO_SIDED||||||t-test, 2 sided|||||||0.6278
71872258|NCT02988622|143262280|SUPERIORITY||Mean Difference (Net)|0.3373|STANDARD_DEVIATION|1.7619||0.0848|TWO_SIDED||||||t-test, 2 sided|||||||0.0848
71872259|NCT02988622|143262281|SUPERIORITY||Mean Difference (Net)|0.2195|STANDARD_DEVIATION|2.0788||0.3418|TWO_SIDED||||||t-test, 2 sided|||||||0.3418
71872260|NCT02988622|143262282|SUPERIORITY||Mean Difference (Net)|0.2375|STANDARD_DEVIATION|1.5528||0.1752|TWO_SIDED||||||t-test, 2 sided|||||||0.1752
71872261|NCT02988622|143262284|SUPERIORITY||Mean Difference (Net)|0.3824|STANDARD_DEVIATION|1.5685||0.0281|TWO_SIDED||||||t-test, 2 sided|||||||0.0281
71872262|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.938|TWO_SIDED|95.0||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.938
71872263|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.451||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.451
71872264|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.819||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.819
71872265|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.5||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.500
71872266|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<.001
71872267|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.001
71872268|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
71872269|NCT06020118|143262285|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants achieving HAI seroconversion (a titer ≥1:40 following ccIIV4 if the baseline titer is \<1:10 or a four-fold rise in titer if the baseline titer is \>1:10) following ccIIV4 vaccination for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
71872270|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.894||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||0.894
71872271|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.104||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||0.104
71872272|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.815||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||0.815
71872273|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.||||||0.814||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||0.814
71872274|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H1N1)pdm09||||<0.001
71872275|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: A(H3N2)||||<0.001
71872276|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Victoria||||<0.001
71872277|NCT06020118|143262286|SUPERIORITY|95% exact Clopper-Pearson confidence boundaries and the p-values were calculated using a logistic regression model adjusted for site.|||||<|0.001||||||Number of participants in each vaccination group with a seroprotective HAI (in a subset of samples) titer (≥1:40) pre- and post-ccIIV4 immunization for each 2023-24 influenza vaccine antigen.|Regression, Logistic|||Antigen: B/Yamagata||||<0.001
71872278|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.699||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.699
71872279|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.88||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||0.880
71872280|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.72||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.720
71872281|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.238||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H3N2)||||0.238
71872282|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.28||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.280
71872283|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.094||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||0.094
71872284|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.216||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.216
71872285|NCT06020118|143262287|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.||||||0.436||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||0.436
71872286|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.615||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H1N1)pdm09||||0.615
71872287|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen A(H1N1)pdm09||||<0.001
71872288|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.87||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen A(H3N2)||||0.870
71872289|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001|||||||Regression, Linear|GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.||Post-vaccine: Antigen A(H3N2)||||<0.001
71872290|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.64||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Victoria||||0.640
71872291|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Victoria||||<0.001
71872292|NCT06020118|143262287|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.444||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Pre-vaccine: Antigen B/Yamagata||||0.444
71872293|NCT06020118|143262287|SUPERIORITY|P values and confidence intervals for the geometric mean titer ratio were estimated using a generalized estimating equation logistic regression accounting for site clustering.|||||<|0.001||||||GMTs and 95% confidence intervals were calculated using a t-distribution on log2-transformed titers.|Regression, Linear|||Post-vaccine: Antigen B/Yamagata||||<0.001
71872294|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.793||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||0.793
71872295|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.326||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||0.326
71872296|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.933||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||0.933
71872297|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.||||||0.424||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||0.424
71872298|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H1N1)pdm09||||<0.001
71872299|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: A(H3N2)||||<0.001
71872300|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Victoria||||<0.001
71872301|NCT06020118|143262288|SUPERIORITY|95% confidence intervals were calculated using a t-distribution on log2-transformed titers and p-values were calculated using a linear regression model adjusted for site.|||||<|0.001||||||Mean fold-rise and 95% confidence intervals were calculated by taking the geometric mean of each individual's ratio of post-to-pre-vaccination titers.|Regression, Linear|||Antigen: B/Yamagata||||<0.001
71872302|NCT01281969|143262312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.97||||0.44|TWO_SIDED|95.0|-7.1|3.15||p-value is unadjusted. a priori threshold for statistical significance is .05|ANCOVA|F(1,34)=0.62, p=.44||Analysis of covariance model controlling for baseline scores. A priori power calculations based on the Perlmutter et al. study (IVIG effect size 1.2) suggested that a sample size of 16 per group would be sufficient to detect an effect size of 1.0 with 80% power.||3.15|-7.1|0.44
71872303|NCT01281969|143262313|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||p-value is not adjusted.|Wilcoxon (Mann-Whitney)|Mean rank sum in the placebo group = 19.92; mean rank sum in the IVIG group = 15.97. Z = -1.18, p=.12||The Wilcoxon two-sample test was used to compare CGI-Improvement ratings (an ordinal variable) at week 6. Power calculation was based on CYBOCS as primary outcome.||||.12
71872304|NCT01281969|143262314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||p-value is not adjusted for multiple comparisons.|Chi-squared|X2 = 0.72, p=.40||Chi-squared test was used to compare distribution of responders by randomization group. Power calculation was based on CY-BOCS (primary outcome).||||.40
71872305|NCT01257425|143262340|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin defined as 0.8 to 1.25|Ratio of AUC values|0.977|||||TWO_SIDED|90.0|0.88|1.08|||ANCOVA|||||1.08|0.88|
71872306|NCT01257425|143262341|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.932|||||TWO_SIDED|90.0|0.82|1.06|||ANCOVA|||||1.06|0.82|
71872307|NCT01257425|143262342|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.91|||||TWO_SIDED|90.0|0.81|1.02|||ANCOVA|||||1.02|0.81|
71872308|NCT01257425|143262344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||ANCOVA|||||0.11|-0.09|0.85
71872309|NCT01257425|143262345|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Log Rank|||||||0.98
71872310|NCT01257425|143262346|SUPERIORITY_OR_OTHER|||||||0.84|||||||Log Rank|||||||0.84
71872311|NCT04262817|143262347|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
71872312|NCT04262817|143262347|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.34
71872313|NCT04262817|143262348|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.38
71872314|NCT04262817|143262348|SUPERIORITY|||||||0.85|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.85
71872315|NCT04262817|143262349|SUPERIORITY|||||||0.39|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.39
71872316|NCT04262817|143262349|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.77
71872317|NCT04262817|143262350|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.43
71872318|NCT04262817|143262350|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.05
71872319|NCT04262817|143262351|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.05
71872320|NCT04262817|143262351|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.04
71872321|NCT04262817|143262352|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||Comparison of Nicotine type.||||0.01
71872322|NCT04262817|143262352|SUPERIORITY|||||||0.38|||||||Mixed Models Analysis|||Comparison of Flavor type.||||0.38
71872323|NCT01182194|143262353|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.5|||||TWO_SIDED|90.0|85.53|100.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||100.03|85.53|
71872324|NCT01182194|143262354|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.76|||||TWO_SIDED|90.0|95.66|101.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.96|95.66|
71872325|NCT01182194|143262355|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.47|||||TWO_SIDED|90.0|95.35|101.7|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||101.70|95.35|
71872326|NCT01182194|143262356|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.45|||||TWO_SIDED|90.0|94.36|109.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||109.08|94.36|
71914997|NCT02820038|143350991|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.13||0.4186|TWO_SIDED|95.0|-0.36|0.15|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.15|-0.36|0.4186
71872327|NCT01182194|143262357|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.54|||||TWO_SIDED|90.0|94.55|102.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||102.71|94.55|
71872328|NCT01182194|143262358|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||TWO_SIDED|90.0|96.07|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.|||103.46|96.07|
71872329|NCT02668185|143262371|SUPERIORITY|Generalised linear mixed model with a Poisson error structure|Mean Difference (Net)|29.66|||<|0.0001|TWO_SIDED|95.0|17.39|42.87||Intention to treat adjusted means.|generalised linear mixed model with a Po|Adjusted for intention to treat||||42.87|17.39|<0.0001
71872330|NCT02668185|143262372|SUPERIORITY||Mean Difference (Net)|50.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71872331|NCT02668185|143262373|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71872332|NCT02668185|143262374|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71872333|NCT02668185|143262375|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71872334|NCT01013597|143262380|SUPERIORITY_OR_OTHER_LEGACY|||||||0.98|||||||t-test, 2 sided|||||||0.98
71872335|NCT00883051|143262425|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||<|0.0001|||||||Cochran-Armitage test for trend|||||||<0.0001
71872336|NCT00883051|143262426|OTHER|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||=|0.0006|||||||Cochran-Armitage test for trend]|||||||=0.0006
71872337|NCT03373201|143262449|SUPERIORITY||Difference between LS means|60.3|||<|0.0001|TWO_SIDED|95.0|44.0|76.7|||ANOVA|||||76.7|44.0|<.0001
71872338|NCT03373201|143262450|SUPERIORITY||Difference between LS Means.|85.5|||<|0.0001|TWO_SIDED|95.0|64.3|106.6|||ANOVA|||||106.6|64.3|<.0001
71872339|NCT03373201|143262451|SUPERIORITY||Difference between LS means|-15.1|||<|0.0001|TWO_SIDED|95.0|-26.2|-4.0|||ANOVA|||||-4.0|-26.2|<.0001
71872340|NCT03373201|143262452|SUPERIORITY||Difference between LS means|-74.6|||<|0.0001|TWO_SIDED|95.0|-94.8|-54.3|||ANOVA|||||-54.3|-94.8|<.0001
71872341|NCT03373201|143262453|SUPERIORITY||Difference between LS Means.|-0.5||||0.0083|TWO_SIDED|95.0|-0.9|-0.1|||ANOVA|||||-0.1|-0.9|0.0083
71872342|NCT03373201|143262454|SUPERIORITY||Difference between LS Means.|6.6||||0.0099|TWO_SIDED|95.0|1.6|11.6|||ANOVA|||||11.6|1.6|0.0099
71872343|NCT02618642|143262455|SUPERIORITY|||||||0.3879|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared||||0.3879
71872344|NCT02618642|143262455|SUPERIORITY|||||||0.5361|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter were compared||||0.5361
71872345|NCT02618642|143262456|SUPERIORITY|||||||0.4669|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.||||0.4669
71872346|NCT02618642|143262456|SUPERIORITY|||||||0.4161|||||||Kruskal-Wallis|||||||0.4161
71872347|NCT02618642|143262457|SUPERIORITY|||||||0.9596|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.9596
71872348|NCT02618642|143262457|SUPERIORITY|||||||0.0907|||||||Kruskal-Wallis|||||||0.0907
71872349|NCT02618642|143262458|SUPERIORITY|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.||||0.0110
71872350|NCT02618642|143262458|SUPERIORITY|||||||0.1165|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter (groups v, x, y,||||0.1165
71872351|NCT02618642|143262459|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||he results in the irradiated group (n=45) and the control group (n=15) were compared||||0.0200
71872352|NCT02618642|143262459|SUPERIORITY|comparison was conducted of the results obtained with a different filter (groups v, x, y,||||||0.0014|||||||Kruskal-Wallis|||||||0.0014
71872353|NCT05269355|143262491|OTHER||Hazard Ratio (HR)|0.61||||0.0017|TWO_SIDED|95.0|0.45|0.83|||Regression, Cox|||||0.83|0.45|0.0017
71872354|NCT01078220|143262497|SUPERIORITY_OR_OTHER||Relative Risk|6.0|||||TWO_SIDED|95.0|3.91|9.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||9.21|3.91|
71872355|NCT01078220|143262497|SUPERIORITY_OR_OTHER||Relative Risk|2.88|||||TWO_SIDED|95.0|1.18|7.08|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|||7.08|1.18|
71872356|NCT01078220|143262501|SUPERIORITY_OR_OTHER||Relative Risk|1.64|||||TWO_SIDED|95.0|1.17|2.3|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||2.3|1.17|
71872357|NCT01078220|143262501|SUPERIORITY_OR_OTHER||Relative Risk|1.05|||||TWO_SIDED|95.0|0.82|1.35|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.35|0.82|
71872358|NCT01078220|143262501|SUPERIORITY_OR_OTHER||Relative Risk|1.02|||||TWO_SIDED|95.0|0.53|1.98|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.||1.98|0.53|
71872359|NCT01078220|143262501|SUPERIORITY_OR_OTHER||Relative Risk|0.78|||||TWO_SIDED|95.0|0.5|1.21|||unconditional logistic regression||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.||1.21|0.5|
71872360|NCT03824639|143262506|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.37|||||TWO_SIDED|||||||||||||
71872361|NCT03824639|143262507|OTHER|Cohen's d will be used to estimate the effect size for comparing change in outcome measurements over 6 months in the exercise group to the control group. This effect size will be used for sample size calculations.|Cohen's d|0.18|||||TWO_SIDED|||||||||||||
71872362|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0213|TWO_SIDED|90.0|0.019|0.14||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg versus (vs) placebo, centrally read||0.140|0.019|0.0213
71872363|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.128||||0.0025|TWO_SIDED|90.0|0.056|0.199||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.199|0.056|0.0025
71872364|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.118||||0.004|TWO_SIDED|90.0|0.048|0.188||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.188|0.048|0.0040
71872365|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.026||||0.1803|TWO_SIDED|90.0|-0.012|0.064||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.064|-0.012|0.1803
71872366|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.08||||0.0582|TWO_SIDED|90.0|0.002|0.159||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.159|0.002|0.0582
71872367|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.178||||0.0014|TWO_SIDED|90.0|0.083|0.272||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.272|0.083|0.0014
71872368|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.122||||0.0125|TWO_SIDED|90.0|0.036|0.208||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.208|0.036|0.0125
71872369|NCT01620255|143262511|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.0927|TWO_SIDED|90.0|-0.009|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.142|-0.009|0.0927
71872370|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.089||||0.1379|TWO_SIDED|90.0|-0.037|0.214||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.214|-0.037|0.1379
71872371|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.254||||0.0011|TWO_SIDED|90.0|0.121|0.388||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.388|0.121|0.0011
71872372|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.163||||0.0239|TWO_SIDED|90.0|0.032|0.293||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.293|0.032|0.0239
71872373|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.213||||0.0052|TWO_SIDED|90.0|0.08|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.347|0.080|0.0052
71872374|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.056||||0.2617|TWO_SIDED|90.0|-0.075|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.186|-0.075|0.2617
71872375|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.212||||0.0058|TWO_SIDED|90.0|0.077|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.347|0.077|0.0058
71872376|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.156||||0.0326|TWO_SIDED|90.0|0.022|0.29||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.290|0.022|0.0326
71872377|NCT01620255|143262512|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.185||||0.0145|TWO_SIDED|90.0|0.05|0.32||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.320|0.050|0.0145
71872378|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.081||||0.0618|TWO_SIDED|90.0|0.0|0.162||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read||0.162|0.000|0.0618
71914998|NCT02820038|143350991|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8848|TWO_SIDED|95.0|-0.28|0.24|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.24|-0.28|0.8848
71914999|NCT02820038|143350992|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.1||0.6403|TWO_SIDED|95.0|-0.15|0.25|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in health status at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.25|-0.15|0.6403
71872379|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.187||||0.0009|TWO_SIDED|90.0|0.091|0.284||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read||0.284|0.091|0.0009
71872380|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.159||||0.0027|TWO_SIDED|90.0|0.068|0.25||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read||0.250|0.068|0.0027
71872381|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.069||||0.0999|TWO_SIDED|90.0|-0.013|0.151||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read||0.151|-0.013|0.0999
71872382|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.001||||0.5225|TWO_SIDED|90.0|-0.111|0.114||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read||0.114|-0.111|0.5225
71872383|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.154||||0.0246|TWO_SIDED|90.0|0.03|0.278||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read||0.278|0.030|0.0246
71872384|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.13||||0.0464|TWO_SIDED|90.0|0.008|0.253||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read||0.253|0.008|0.0464
71872385|NCT01620255|143262513|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.066||||0.2|TWO_SIDED|90.0|-0.053|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read||0.186|-0.053|0.2000
71872386|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean (LSM) Difference|-0.88||||0.0494|TWO_SIDED|90.0|-1.623|-0.145|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, centrally read change||-0.145|-1.623|0.0494
71872387|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.53||||0.0005|TWO_SIDED|90.0|-2.254|-0.809|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, centrally read change||-0.809|-2.254|0.0005
71872388|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.12||||0.0117|TWO_SIDED|90.0|-1.845|-0.39|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, centrally read change||-0.390|-1.845|0.0117
71872389|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.27||||0.0049|TWO_SIDED|90.0|-2.016|-0.533|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, centrally read change||-0.533|-2.016|0.0049
71872390|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.94||||0.0543|TWO_SIDED|90.0|-1.737|-0.137|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, locally read change||-0.137|-1.737|0.0543
71872391|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.6||||0.0008|TWO_SIDED|90.0|-2.372|-0.819|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, locally read change||-0.819|-2.372|0.0008
71872392|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.07||||0.0255|TWO_SIDED|90.0|-1.858|-0.284|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, locally read change||-0.284|-1.858|0.0255
71872393|NCT01620255|143262515|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.29||||0.0079|TWO_SIDED|90.0|-2.082|-0.493|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, locally read change||-0.493|-2.082|0.0079
71872394|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.1016|TWO_SIDED|90.0|-0.511|0.001|||Mixed Models Analysis|Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W4||0.001|-0.511|0.1016
71872395|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0654|TWO_SIDED|90.0|-0.529|-0.03|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W4||-0.030|-0.529|0.0654
71872396|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.15|TWO_SIDED|90.0|-0.472|0.031|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W4||0.031|-0.472|0.1500
71872397|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.38||||0.0132|TWO_SIDED|90.0|-0.637|-0.129|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W4||-0.129|-0.637|0.0132
71872398|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.3||||0.0526|TWO_SIDED|90.0|-0.555|-0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W8||-0.046|-0.555|0.0526
71872399|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.31||||0.0422|TWO_SIDED|90.0|-0.554|-0.058|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W8||-0.058|-0.554|0.0422
71872400|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.011|TWO_SIDED|90.0|-0.637|-0.137|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W8||-0.137|-0.637|0.0110
71872401|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.5||||0.001|TWO_SIDED|90.0|-0.755|-0.254|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W8||-0.254|-0.755|0.0010
71872402|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1611|TWO_SIDED|90.0|-0.475|0.038|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W12||0.038|-0.475|0.1611
71872403|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.36||||0.0186|TWO_SIDED|90.0|-0.608|-0.108|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W12||-0.108|-0.608|0.0186
71872404|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1647|TWO_SIDED|90.0|-0.465|0.039|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W12||0.039|-0.465|0.1647
71872405|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.35||||0.0231|TWO_SIDED|90.0|-0.607|-0.097|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W12||-0.097|-0.607|0.0231
71872406|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.46||||0.0002|TWO_SIDED|90.0|-0.658|-0.26|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4||-0.260|-0.658|0.0002
71872407|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.52|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.322|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4||-0.322|-0.710|<0.0001
71872408|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.49|||<|0.0001|TWO_SIDED|90.0|-0.686|-0.295|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W4||-0.295|-0.686|<0.0001
71872409|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.39||||0.0012|TWO_SIDED|90.0|-0.587|-0.192|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W4||-0.192|-0.587|0.0012
71872410|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.28||||0.0207|TWO_SIDED|90.0|-0.475|-0.081|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8||-0.081|-0.475|0.0207
71872411|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0402|TWO_SIDED|90.0|-0.432|-0.048|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8||-0.048|-0.432|0.0402
71872412|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0071|TWO_SIDED|90.0|-0.511|-0.124|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W8||-0.124|-0.511|0.0071
71872413|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.47|||<|0.0001|TWO_SIDED|90.0|-0.664|-0.275|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W8||-0.275|-0.664|<0.0001
71872414|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0395|TWO_SIDED|90.0|-0.449|-0.05|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12||-0.050|-0.449|0.0395
71872415|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.32||||0.0073|TWO_SIDED|90.0|-0.511|-0.123|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12||-0.123|-0.511|0.0073
71872416|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.24||||0.0413|TWO_SIDED|90.0|-0.439|-0.047|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W12||-0.047|-0.439|0.0413
71872417|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.4||||0.0008|TWO_SIDED|90.0|-0.602|-0.206|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W12||-0.206|-0.602|0.0008
71872418|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.19||||0.1862|TWO_SIDED|90.0|-0.421|0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W4||0.046|-0.421|0.1862
71872419|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0998|TWO_SIDED|90.0|-0.455|0.0|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W4||-0.000|-0.455|0.0998
71872420|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.22||||0.1085|TWO_SIDED|90.0|-0.453|0.006|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W4||0.006|-0.453|0.1085
71872421|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.14||||0.3161|TWO_SIDED|90.0|-0.372|0.09|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W4||0.090|-0.372|0.3161
71872422|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.1||||0.4962|TWO_SIDED|90.0|-0.328|0.136|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W8||0.136|-0.328|0.4962
71872423|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.29||||0.0371|TWO_SIDED|90.0|-0.512|-0.06|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W8||-0.060|-0.512|0.0371
71872424|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.21||||0.1212|TWO_SIDED|90.0|-0.441|0.013|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W8||0.013|-0.441|0.1212
71872425|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.18||||0.187|TWO_SIDED|90.0|-0.41|0.045|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W8||0.045|-0.410|0.1870
71872426|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.1133|TWO_SIDED|90.0|-0.459|0.009|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W12||0.009|-0.459|0.1133
71872427|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.43||||0.0022|TWO_SIDED|90.0|-0.653|-0.198|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W12||-0.198|-0.653|0.0022
71683223|NCT01492101|142884685|EQUIVALENCE|\[9\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|7.3|||<|0.0001|TWO_SIDED|95.0|3.88|10.67|||F-test|||||10.67|3.88|<0.0001
71872428|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0788|TWO_SIDED|90.0|-0.475|-0.016|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W12||-0.016|-0.475|0.0788
71872429|NCT01620255|143262516|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.25||||0.0717|TWO_SIDED|90.0|-0.485|-0.022|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W12||-0.022|-0.485|0.0717
71872430|NCT01620255|143262517|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.08||||0.5406|TWO_SIDED|90.0|-0.286|0.131|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo||0.131|-0.286|0.5406
71872431|NCT01620255|143262517|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.42||||0.0007|TWO_SIDED|90.0|-0.628|-0.221|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo||-0.221|-0.628|0.0007
71872432|NCT01620255|143262517|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.34||||0.0063|TWO_SIDED|90.0|-0.549|-0.137|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 75 mg vs placebo||-0.137|-0.549|0.0063
71872433|NCT01620255|143262517|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.23||||0.0748|TWO_SIDED|90.0|-0.436|-0.018|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 225 mg vs placebo||-0.018|-0.436|0.0748
71872434|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.9||||0.9744|TWO_SIDED|90.0|-101.0|97.14|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||97.14|-101.00|0.9744
71872435|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|74.9||||0.2023|TWO_SIDED|90.0|-21.77|171.66|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||171.66|-21.77|0.2023
71872436|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|32.9||||0.5808|TWO_SIDED|90.0|-65.09|130.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||130.79|-65.09|0.5808
71872437|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|37.6||||0.5388|TWO_SIDED|90.0|-63.12|138.34|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||138.34|-63.12|0.5388
71872438|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-8.2||||0.8902|TWO_SIDED|90.0|-106.24|89.81|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||89.81|-106.24|0.8902
71872439|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|10.2||||0.8616|TWO_SIDED|90.0|-86.14|106.54|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||106.54|-86.14|0.8616
71872440|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-34.3||||0.5684|TWO_SIDED|90.0|-133.49|64.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||64.79|-133.49|0.5684
71872441|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|33.8||||0.57|TWO_SIDED|90.0|-64.2|131.86|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||131.86|-64.20|0.5700
71872442|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-30.0||||0.6234|TWO_SIDED|90.0|-130.56|70.57|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||70.57|-130.56|0.6234
71872443|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|36.0||||0.5474|TWO_SIDED|90.0|-62.44|134.38|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||134.38|-62.44|0.5474
71872444|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|78.5||||0.1918|TWO_SIDED|90.0|-20.48|177.56|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||177.56|-20.48|0.1918
71872445|NCT01620255|143262518|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-3.0||||0.9615|TWO_SIDED|90.0|-104.88|98.91|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||98.91|-104.88|0.9615
71872446|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|6.4||||0.9328|TWO_SIDED|90.0|-118.6|131.41|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4||131.41|-118.60|0.9328
71915000|NCT02820038|143350992|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.8766|TWO_SIDED|95.0|-0.14|0.16|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in global health status between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.16|-0.14|0.8766
71872447|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-9.8||||0.8962|TWO_SIDED|90.0|-132.91|113.39|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4||113.39|-132.91|0.8962
71872448|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.5||||0.8775|TWO_SIDED|90.0|-110.83|133.74|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4||133.74|-110.83|0.8775
71872449|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-17.0||||0.8224|TWO_SIDED|90.0|-142.02|107.94|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4||107.94|-142.02|0.8224
71872450|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-52.7||||0.4831|TWO_SIDED|90.0|-176.48|71.02|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8||71.02|-176.48|0.4831
71872451|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.2||||0.1183|TWO_SIDED|90.0|-236.63|6.13|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8||6.13|-236.63|0.1183
71872452|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-115.8||||0.1139|TWO_SIDED|90.0|-236.29|4.69|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8||4.69|-236.29|0.1139
71872453|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-96.4||||0.1931|TWO_SIDED|90.0|-218.17|25.46|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8||25.46|-218.17|0.1931
71872454|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-119.7||||0.1182|TWO_SIDED|90.0|-245.66|6.32|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12||6.32|-245.66|0.1182
71872455|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-41.7||||0.5784|TWO_SIDED|90.0|-165.34|81.87|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12||81.87|-165.34|0.5784
71915001|NCT02820038|143350992|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.08||0.7603|TWO_SIDED|95.0|-0.13|0.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater improvement in global health status between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.18|-0.13|0.7603
71915002|NCT02820038|143350993|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7093|TWO_SIDED|95.0|-0.43|0.63|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in disease activity at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.63|-0.43|0.7093
71915003|NCT02820038|143350993|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.5941|TWO_SIDED|95.0|-0.3|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.52|-0.30|0.5941
71915004|NCT02820038|143350993|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9476|TWO_SIDED|95.0|-0.42|0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.40|-0.42|0.9476
71872456|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-163.6||||0.0279|TWO_SIDED|90.0|-285.84|-41.29|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12||-41.29|-285.84|0.0279
71872457|NCT01620255|143262519|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-123.5||||0.1053|TWO_SIDED|90.0|-249.0|1.93|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12||1.93|-249.00|0.1053
71872458|NCT01620255|143262520|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-1.1||||0.8302|TWO_SIDED|90.0|-9.507|7.317|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, change from BL at W12||7.317|-9.507|0.8302
71872459|NCT01620255|143262520|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|12.33||||0.0141|TWO_SIDED|90.0|4.084|20.567|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, change from BL at W12||20.567|4.084|0.0141
71872460|NCT01620255|143262520|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|11.7||||0.0182|TWO_SIDED|90.0|3.564|19.84|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, change from BL at W12||19.840|3.564|0.0182
71872461|NCT01620255|143262520|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|15.48||||0.0026|TWO_SIDED|90.0|7.056|23.907|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, change from BL at W12||23.907|7.056|0.0026
71872462|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.73||||0.6862|TWO_SIDED|90.0|-3.689|2.235|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12||2.235|-3.689|0.6862
71872463|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.37||||0.0135|TWO_SIDED|90.0|1.467|7.28|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12||7.280|1.467|0.0135
71915005|NCT02820038|143350994|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.8||0.9128|TWO_SIDED|95.0|-1.65|1.48|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in depression at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.48|-1.65|0.9128
71915006|NCT02820038|143350994|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.62||0.6312|TWO_SIDED|95.0|-1.5|0.91|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.91|-1.50|0.6312
71915007|NCT02820038|143350994|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.35|STANDARD_ERROR_OF_MEAN|0.62||0.5766|TWO_SIDED|95.0|-1.57|0.87|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.87|-1.57|0.5766
71915008|NCT02820038|143350995|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|1.04||0.2123|TWO_SIDED|95.0|-3.34|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in fatigue at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.75|-3.34|0.2123
71915009|NCT02820038|143350995|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.81||0.2691|TWO_SIDED|95.0|-2.48|0.7|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.70|-2.48|0.2691
71915010|NCT02820038|143350995|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.81||0.5655|TWO_SIDED|95.0|-2.06|1.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.13|-2.06|0.5655
71872464|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.16||||0.0171|TWO_SIDED|90.0|1.293|7.023|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, bowel fx change from BL at W12||7.023|1.293|0.0171
71872465|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.2||||0.0041|TWO_SIDED|90.0|2.232|8.172|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, bowel fx change from BL at W12||8.172|2.232|0.0041
71872466|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|0.22||||0.9072|TWO_SIDED|90.0|-2.897|3.339|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12||3.339|-2.897|0.9072
71872467|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.47||||0.0161|TWO_SIDED|90.0|1.42|7.522|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12||7.522|1.420|0.0161
71872468|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|4.06||||0.0271|TWO_SIDED|90.0|1.042|7.071|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, emotional fx change from BL at W12||7.071|1.042|0.0271
71872469|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|5.9||||0.002|TWO_SIDED|90.0|2.778|9.026|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, emotional fx change from BL at W12||9.026|2.778|0.0020
71915011|NCT02820038|143350996|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|4.1||0.5364|TWO_SIDED|95.0|-5.51|10.55|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in health literacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||10.55|-5.51|0.5364
71915012|NCT02820038|143350996|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|3.24||0.605|TWO_SIDED|95.0|-4.68|8.01|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||8.01|-4.68|0.6050
71915013|NCT02820038|143350996|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|3.24||0.924|TWO_SIDED|95.0|-6.66|6.05|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||6.05|-6.66|0.9240
71915014|NCT02820038|143350997|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7871|TWO_SIDED|95.0|0.43|1.89|||Regression, Logistic||Modeled probability of attending at least one class session. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to participate in the BetterChoices, BetterHealth program if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.89|0.43|0.7871
71872470|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.26||||0.7711|TWO_SIDED|90.0|-1.756|1.229|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12||1.229|-1.756|0.7711
71872471|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.69||||0.0582|TWO_SIDED|90.0|0.223|3.147|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12||3.147|0.223|0.0582
71872472|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.68||||0.0558|TWO_SIDED|90.0|0.235|3.12|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12||3.120|0.235|0.0558
71872473|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.66||||0.0686|TWO_SIDED|90.0|0.161|3.153|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12||3.153|0.161|0.0686
71872474|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|-0.33||||0.7561|TWO_SIDED|90.0|-2.094|1.429|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, social fx change from BL at W12||1.429|-2.094|0.7561
71872475|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.17||||0.0384|TWO_SIDED|90.0|0.447|3.891|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, social fx change from BL at W12||3.891|0.447|0.0384
71872476|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|1.86||||0.0729|TWO_SIDED|90.0|0.154|3.557|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, social fx change from BL at W12||3.557|0.154|0.0729
71872477|NCT01620255|143262521|SUPERIORITY_OR_OTHER_LEGACY||LSM Difference|2.95||||0.006|TWO_SIDED|90.0|1.19|4.715|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, social fx change from BL at W12||4.715|1.190|0.0060
71872478|NCT01620255|143262522|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-0.002||||0.5201|TWO_SIDED|90.0|-0.145|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo||0.142|-0.145|0.5201
71872479|NCT01620255|143262522|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.183||||0.0217|TWO_SIDED|90.0|0.039|0.328||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo||0.328|0.039|0.0217
71872480|NCT01620255|143262522|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.096||||0.1473|TWO_SIDED|90.0|-0.045|0.237||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo||0.237|-0.045|0.1473
71872481|NCT01620255|143262522|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|0.112||||0.1231|TWO_SIDED|90.0|-0.038|0.261||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo||0.261|-0.038|0.1231
71872482|NCT03794908|143262526|SUPERIORITY||Mean Difference (Net)|3.8|STANDARD_ERROR_OF_MEAN|3.49||0.28|TWO_SIDED|95.0|-3.03|10.64|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at mid-treatment.||10.64|-3.03|0.28
71872483|NCT03794908|143262526|SUPERIORITY||Mean Difference (Net)|4.48|STANDARD_ERROR_OF_MEAN|3.53||0.21|TWO_SIDED|95.0|-2.44|11.4|||Mixed Models Analysis|The comparison was done using a mixed model with assessments at 3 time points (pre-treatment, mid-treatment, and end of treatment).||Test of between-arm difference at end of treatment.||11.40|-2.44|0.21
71872484|NCT00388453|143262532|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||.05
71872485|NCT03818204|143262545|OTHER||||||>=|0.46|||||||Regression, Linear|||The effect of angular position was modeled using linear mixed-effects (multiple regression) models. The five angles were randomly mapped for the dependent variable interpalpebral fissure. Because there were repeated measurements on each eye and each participant might respond differently to each angular position, participant and angular position within participant-eye were included as random effects.||||>=0.46
71872486|NCT00879762|143262553|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.587|||||TWO_SIDED|95.0|0.398|0.868|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.868|0.398|
71872487|NCT00879762|143262554|NON_INFERIORITY|The non-inferiority margin is 2.5. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the hazard ratio is less than 2.5.|Hazard Ratio (HR)|0.583|||||TWO_SIDED|95.0|0.384|0.853|||||A survival analysis for interval censored data was performed to estimate the hazard ratio. The 95% CI for the hazard ratio was estimated using bootstrap.|Null hypothesis: Median time to seroconversion among participants receiving one standard dose in Group B is 2.5-fold higher compared to participants receiving one high dose in Group A (hazard ratio = 2.5).||0.853|0.384|
71872488|NCT00879762|143262560|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.38|||||TWO_SIDED|95.0|-0.2|0.97|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||0.97|-0.20|
71872489|NCT00879762|143262561|NON_INFERIORITY|The non-inferiority margin is 1. Non-inferiority of Group B is concluded if the upper limit of the 95% confidence interval for the mean difference in the log2.5 transformed peak titers between groups is less than 1.|Mean Difference (Final Values)|0.42|||||TWO_SIDED|95.0|-0.17|1.0|||||Estimate and corresponding 95% confidence interval are calculated on the log2.5 scale.|Null hypothesis: The mean difference in log2.5 transformed peak titers between Group A and Group B \>= 1.||1.00|-0.17|
71872490|NCT04981366|143262562|SUPERIORITY|||||||0.013|TWO_SIDED|95.0||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.013
71872491|NCT04981366|143262563|SUPERIORITY||||||<|0.001||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||<0.001
71872492|NCT04981366|143262564|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872493|NCT04981366|143262565|SUPERIORITY|||||||0.007||||||We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.|Mixed Models Analysis|||||||0.007
71915015|NCT02820038|143350997|SUPERIORITY||Odds Ratio (OR)|1.189||||0.5815|TWO_SIDED|95.0|0.643|2.198|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices,BetterHealth program if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.198|0.643|0.5815
71915016|NCT02820038|143350997|SUPERIORITY||Odds Ratio (OR)|0.679||||0.2211|TWO_SIDED|95.0|0.366|1.262|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices, BetterHealth program if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.262|0.366|0.2211
71915017|NCT02820038|143350998|SUPERIORITY||Odds Ratio (OR)|0.804||||0.574|TWO_SIDED|95.0|0.38|1.72|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to use the RA Self-Management website if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||1.72|0.38|0.5740
71915018|NCT02820038|143350998|SUPERIORITY||Odds Ratio (OR)|1.425||||0.1278|TWO_SIDED|95.0|0.766|2.649|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.649|0.766|0.1278
71915019|NCT02820038|143350998|SUPERIORITY||Odds Ratio (OR)|0.614||||0.1278|TWO_SIDED|95.0|0.328|1.15|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||1.15|0.328|0.1278
71872494|NCT04981366|143262566|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872495|NCT04981366|143262567|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872496|NCT04981366|143262568|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|||||||0.005
71872497|NCT04981366|143262569|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872498|NCT04981366|143262570|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872499|NCT04981366|143262571|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872500|NCT04981366|143262572|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872501|NCT04981366|143262573|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71872502|NCT04981366|143262574|SUPERIORITY|||||||0.033|||||||Mixed Models Analysis|||||||0.033
71872503|NCT04981366|143262575|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
71872504|NCT04981366|143262576|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|||||||0.203
71872505|NCT04981366|143262577|SUPERIORITY|||||||0.027|||||||Mixed Models Analysis|||||||0.027
71872506|NCT04981366|143262578|SUPERIORITY|||||||0.145|||||||Mixed Models Analysis|||||||0.145
71872507|NCT04981366|143262579|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71872508|NCT04981366|143262580|SUPERIORITY|||||||0.551|||||||Mixed Models Analysis|||||||0.551
71872509|NCT04981366|143262581|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71872510|NCT04981366|143262582|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71872511|NCT04981366|143262583|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71872512|NCT04981366|143262584|SUPERIORITY|||||||0.008|||||||Mixed Models Analysis|||||||0.008
71872513|NCT04981366|143262585|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872514|NCT04981366|143262586|SUPERIORITY|||||||0.344|||||||Mixed Models Analysis|||||||0.344
71872515|NCT04981366|143262587|SUPERIORITY|||||||0.613|||||||Mixed Models Analysis|||||||0.613
71872516|NCT04981366|143262588|SUPERIORITY|||||||0.944|||||||Mixed Models Analysis|||||||0.944
71872517|NCT04981366|143262589|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
71872518|NCT04981366|143262590|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872519|NCT04981366|143262591|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872520|NCT04981366|143262592|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872521|NCT04981366|143262594|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872522|NCT04981366|143262595|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872523|NCT04981366|143262596|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872524|NCT04981366|143262597|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71915020|NCT02820038|143350999|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|11.9|STANDARD_ERROR_OF_MEAN|8.7||0.17|TWO_SIDED|95.0|-5.2|28.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||28.9|-5.2|0.17
71872525|NCT04981366|143262598|SUPERIORITY|||||||0.017|||||||Mixed Models Analysis|||||||0.017
71872526|NCT04981366|143262599|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872527|NCT04981366|143262600|SUPERIORITY|||||||0.949|||||||Mixed Models Analysis|||||||0.949
71872528|NCT04981366|143262601|SUPERIORITY|||||||0.993|||||||Mixed Models Analysis|||||||0.993
71872529|NCT04981366|143262602|SUPERIORITY|||||||0.601|||||||Mixed Models Analysis|||||||0.601
71872530|NCT04981366|143262603|SUPERIORITY|||||||0.408|||||||Mixed Models Analysis|||||||0.408
71872531|NCT04981366|143262604|SUPERIORITY|||||||0.082|||||||Mixed Models Analysis|||||||0.082
71872532|NCT04981366|143262605|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||||||0.550
71872533|NCT04981366|143262606|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.700
71872534|NCT04981366|143262607|SUPERIORITY|||||||0.254|||||||Mixed Models Analysis|||||||0.254
71872535|NCT04981366|143262608|SUPERIORITY|||||||0.373|||||||Mixed Models Analysis|||||||0.373
71872536|NCT04981366|143262609|SUPERIORITY|||||||0.407|||||||Mixed Models Analysis|||||||0.407
71872537|NCT04981366|143262610|SUPERIORITY|||||||0.051|||||||Mixed Models Analysis|||||||0.051
71872538|NCT04981366|143262611|SUPERIORITY|||||||0.385|||||||Mixed Models Analysis|||||||0.385
71872539|NCT04981366|143262612|SUPERIORITY|||||||0.239|||||||Mixed Models Analysis|||||||0.239
71872540|NCT04981366|143262613|SUPERIORITY|||||||0.463|||||||Mixed Models Analysis|||||||0.463
71872541|NCT04981366|143262614|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||||||0.032
71872542|NCT04981366|143262615|SUPERIORITY|||||||0.469|||||||Mixed Models Analysis|||||||0.469
71872543|NCT04981366|143262616|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71872544|NCT04981366|143262617|SUPERIORITY|||||||0.064|||||||Mixed Models Analysis|||||||0.064
71872545|NCT04981366|143262618|SUPERIORITY|||||||0.0314|||||||Mixed Models Analysis|||||||0.0314
71872546|NCT04981366|143262619|SUPERIORITY|||||||0.0147|||||||Mixed Models Analysis|||||||0.0147
71872547|NCT04981366|143262620|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||||||0.007
71872548|NCT04981366|143262621|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71872549|NCT04981366|143262622|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71872550|NCT01122862|143262729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.21||||0.0915|TWO_SIDED|95.0|-0.45|0.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.03|-0.45|0.0915
71872551|NCT01122862|143262730|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference in treatments being compared.||1.90|1.42|<0.0001
71872552|NCT01122862|143262731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04||||0.6682|TWO_SIDED|95.0|-0.14|0.21|||ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.21|-0.14|0.6682
71872553|NCT01122862|143262731|SUPERIORITY_OR_OTHER||Adjusted Mean DIfference|0.74|||<|0.0001|TWO_SIDED|95.0|0.57|0.92||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.92|0.57|<0.0001
71872554|NCT01122862|143262732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.2||||0.11|TWO_SIDED|95.0|-0.44|0.05||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.05|-0.44|0.1100
71915021|NCT02820038|143350999|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable|Mean Difference (Net)|16.0|STANDARD_ERROR_OF_MEAN|6.9||0.02|TWO_SIDED|95.0|2.5|29.5|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||29.5|2.5|0.02
71915022|NCT02820038|143350999|SUPERIORITY|Regression model adjusted for baseline values of the dependent variable.|Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|6.9||0.42|TWO_SIDED|95.0|-8.1|19.2|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||19.2|-8.1|0.42
71915023|NCT02820038|143351000|SUPERIORITY||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|0.15||0.15|TWO_SIDED|95.0|-5.2|0.8|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.8|-5.2|0.15
71915024|NCT02820038|143351000|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.2||0.07|TWO_SIDED|95.0|-4.4|0.3|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.3|-4.4|0.07
71915025|NCT02820038|143351000|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|1.2||0.13|TWO_SIDED|95.0|-4.2|0.6|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.6|-4.2|0.13
71915026|NCT02820038|143351001|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.12||0.68|TWO_SIDED|95.0|-0.19|0.29|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||0.29|-0.19|0.68
71915027|NCT02820038|143351001|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.1||0.2|TWO_SIDED|95.0|-0.06|0.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.31|-0.06|0.20
71915028|NCT02820038|143351001|SUPERIORITY||Mean Difference (Net)|0.001|STANDARD_ERROR_OF_MEAN|0.1||0.99|TWO_SIDED|95.0|-0.19|0.19|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-week follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||0.19|-0.19|0.99
71915029|NCT02820038|143351002|SUPERIORITY||Odds Ratio (OR)|2.105||||0.0028|TWO_SIDED|95.0|1.291|3.432|||Regression, Logistic|||The investigators hypothesized that participants would be more likely to view at least one webpage if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Modeled probability of viewing at least one webpage. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|3.432|1.291|0.0028
71683224|NCT01492101|142884685|EQUIVALENCE|\[10\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1252|TWO_SIDED|95.0|-7.59|0.93|||F-test|||||0.93|-7.59|0.1252
71683225|NCT01492101|142884685|EQUIVALENCE|\[11\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.1717|TWO_SIDED|95.0|-6.83|1.22|||F-test|||||1.22|-6.83|0.1717
71683226|NCT01492101|142884685|EQUIVALENCE|\[12\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.5513|TWO_SIDED|95.0|-5.95|3.18|||F-test|||||3.18|-5.95|0.5513
71872555|NCT01122862|143262732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.68|||<|0.0001|TWO_SIDED|95.0|1.44|1.93||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.93|1.44|<0.0001
71872556|NCT01122862|143262733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.03||||0.728||95.0|-0.16|0.23||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||0.23|-0.16|0.7280
71872557|NCT01122862|143262733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.88|||<|0.0001|TWO_SIDED|95.0|0.68|1.08||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.||1.08|0.68|<0.0001
71872558|NCT03421431|143262776|SUPERIORITY||Least Squares (LS) mean difference|12.46||||0.0495|TWO_SIDED|95.0|0.029|24.891|||ANCOVA|||||24.891|0.029|0.0495
71872559|NCT03421431|143262776|SUPERIORITY||LS mean difference|6.257||||0.3039|TWO_SIDED|95.0|-5.754|18.268|||ANCOVA|||||18.268|-5.754|0.3039
71872560|NCT03421431|143262776|SUPERIORITY||LS mean difference|6.203||||0.213|TWO_SIDED|95.0|-3.615|16.021|||ANCOVA|||||16.021|-3.615|0.2130
71872561|NCT03421431|143262777|SUPERIORITY||LS mean difference|4.717||||0.0009|TWO_SIDED|95.0|1.98|7.455|||ANCOVA|||||7.455|1.980|0.0009
71872562|NCT03421431|143262777|SUPERIORITY||LS mean difference|0.934||||0.4946|TWO_SIDED|95.0|-1.766|3.635|||ANCOVA|||||3.635|-1.766|0.4946
71872563|NCT03421431|143262777|SUPERIORITY||LS mean difference|3.783||||0.0005|TWO_SIDED|95.0|1.708|5.858|||ANCOVA|||||5.858|1.708|0.0005
71872564|NCT03421431|143262778|SUPERIORITY||LS mean difference|0.076||||0.2756|TWO_SIDED|95.0|-0.062|0.214|||ANCOVA|||||0.214|-0.062|0.2756
71872565|NCT03421431|143262778|SUPERIORITY||LS mean difference|-0.003||||0.9686|TWO_SIDED|95.0|-0.136|0.131|||ANCOVA|||||0.131|-0.136|0.9686
71872566|NCT03421431|143262778|SUPERIORITY||LS mean difference|0.079||||0.1406|TWO_SIDED|95.0|-0.026|0.184|||ANCOVA|||||0.184|-0.026|0.1406
71872567|NCT03421431|143262779|SUPERIORITY||LS mean difference|-0.125||||0.613|TWO_SIDED|95.0|-0.613|0.363|||ANCOVA|||||0.363|-0.613|0.6130
71872568|NCT03421431|143262779|SUPERIORITY||LS mean difference|-0.049||||0.8366|TWO_SIDED|95.0|-0.521|0.423|||ANCOVA|||||0.423|-0.521|0.8366
71872569|NCT03421431|143262779|SUPERIORITY||LS mean difference|-0.076||||0.7015|TWO_SIDED|95.0|-0.466|0.315|||ANCOVA|||||0.315|-0.466|0.7015
71872570|NCT03421431|143262780|SUPERIORITY||LS mean difference|-0.186||||0.3875|TWO_SIDED|95.0|-0.613|0.24|||ANCOVA|||||0.240|-0.613|0.3875
71872571|NCT03421431|143262780|SUPERIORITY||LS mean difference|-0.248||||0.2331|TWO_SIDED|95.0|-0.657|0.162|||ANCOVA|||||0.162|-0.657|0.2331
71872572|NCT03421431|143262780|SUPERIORITY||LS mean difference|0.061||||0.7164|TWO_SIDED|95.0|-0.272|0.395|||ANCOVA|||||0.395|-0.272|0.7164
71872573|NCT03421431|143262781|SUPERIORITY||LS mean difference|0.21|||<|0.0001|TWO_SIDED|95.0|0.11|0.311|||ANCOVA|||||0.311|0.110|<0.0001
71872574|NCT03421431|143262781|SUPERIORITY||LS mean difference|0.046||||0.348|TWO_SIDED|95.0|-0.051|0.143|||ANCOVA|||||0.143|-0.051|0.3480
71872575|NCT03421431|143262781|SUPERIORITY||LS mean difference|0.164|||<|0.0001|TWO_SIDED|95.0|0.085|0.243|||ANCOVA|||||0.243|0.085|<0.0001
71872576|NCT03421431|143262782|SUPERIORITY||LS mean difference|-0.299||||0.0897|TWO_SIDED|95.0|-0.645|0.047|||ANCOVA|||||0.047|-0.645|0.0897
71872577|NCT03421431|143262782|SUPERIORITY||LS mean difference|-0.251||||0.1411|TWO_SIDED|95.0|-0.586|0.085|||ANCOVA|||||0.085|-0.586|0.1411
71872578|NCT03421431|143262782|SUPERIORITY||LS mean difference|-0.048||||0.733|TWO_SIDED|95.0|-0.326|0.23|||ANCOVA|||||0.230|-0.326|0.7330
71872579|NCT03421431|143262783|SUPERIORITY||LS mean difference|51.873||||0.9143|TWO_SIDED|95.0|-901.574|1005.32|||ANCOVA|||||1005.320|-901.574|0.9143
71872580|NCT03421431|143262783|SUPERIORITY||LS mean difference|404.168||||0.3718|TWO_SIDED|95.0|-489.519|1297.854|||ANCOVA|||||1297.854|-489.519|0.3718
71872581|NCT03421431|143262783|SUPERIORITY||LS mean difference|-352.295||||0.3466|TWO_SIDED|95.0|-1091.308|386.719|||ANCOVA|||||386.719|-1091.308|0.3466
71872582|NCT03421431|143262784|SUPERIORITY||LS mean difference|0.173||||0.0003|TWO_SIDED|95.0|0.081|0.264|||ANCOVA|||||0.264|0.081|0.0003
71872583|NCT03421431|143262784|SUPERIORITY||LS mean difference|0.025||||0.5685|TWO_SIDED|95.0|-0.062|0.113|||ANCOVA|||||0.113|-0.062|0.5685
71872584|NCT03421431|143262784|SUPERIORITY||LS mean difference|0.147|||<|0.0001|TWO_SIDED|95.0|0.075|0.219|||ANCOVA|||||0.219|0.075|<0.0001
71872585|NCT03421431|143262785|SUPERIORITY||LS mean difference|-0.133||||0.0282|TWO_SIDED|95.0|-0.252|-0.015|||ANCOVA|||||-0.015|-0.252|0.0282
71872586|NCT03421431|143262785|SUPERIORITY||LS mean difference|-0.068||||0.2412|TWO_SIDED|95.0|-0.182|0.046|||ANCOVA|||||0.046|-0.182|0.2412
71872587|NCT03421431|143262785|SUPERIORITY||LS mean difference|-0.066||||0.1649|TWO_SIDED|95.0|-0.158|0.027|||ANCOVA|||||0.027|-0.158|0.1649
71872588|NCT03421431|143262786|SUPERIORITY||LS mean difference|0.009||||0.4357|TWO_SIDED|95.0|-0.014|0.032|||ANCOVA|||||0.032|-0.014|0.4357
71872589|NCT03421431|143262786|SUPERIORITY||LS mean difference|0.001||||0.8989|TWO_SIDED|95.0|-0.021|0.023|||ANCOVA|||||0.023|-0.021|0.8989
71872590|NCT03421431|143262786|SUPERIORITY||LS mean difference|0.008||||0.412|TWO_SIDED|95.0|-0.011|0.026|||ANCOVA|||||0.026|-0.011|0.4120
71872591|NCT03421431|143262787|SUPERIORITY||LS mean difference|-1.731||||0.0134|TWO_SIDED|95.0|-3.095|-0.368|||ANCOVA|||||-0.368|-3.095|0.0134
71872592|NCT03421431|143262787|SUPERIORITY||LS mean difference|-0.327||||0.6263|TWO_SIDED|95.0|-1.656|1.001|||ANCOVA|||||1.001|-1.656|0.6263
71872593|NCT03421431|143262787|SUPERIORITY||LS mean difference|-1.404||||0.0115|TWO_SIDED|95.0|-2.487|-0.322|||ANCOVA|||||-0.322|-2.487|0.0115
71872594|NCT03421431|143262788|SUPERIORITY||LS mean difference|-3.723||||0.4608|TWO_SIDED|95.0|-13.7|6.253|||ANCOVA|||||6.253|-13.700|0.4608
71915030|NCT02820038|143351003|SUPERIORITY||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|0.45||0.0601|TWO_SIDED|95.0|-1.71|0.04|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would view more webpages if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||0.04|-1.71|0.0601
71915031|NCT02820038|143351004|SUPERIORITY||Odds Ratio (OR)|0.91||||0.9|TWO_SIDED|95.0|0.22|3.81|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to be using at least one DMARD (Disease-Modifying Antirheumatic Drug) at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.||3.81|0.22|0.90
71915032|NCT02820038|143351004|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|0.75||||0.63|TWO_SIDED|95.0|0.24|2.35|||Regression, Logistic||. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART; 1=DFB Only, DFB+SMART|The investigators hypothesized that participants would exhibit a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.||2.35|0.24|0.63
71915033|NCT02820038|143351004|SUPERIORITY|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|1.15||||0.81|TWO_SIDED|95.0|0.37|3.54|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, DrugFactsBox® (DFB) Only; 1=Other CMI+SMART, DFB+SMART|The investigators hypothesized that participants would experience a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.||3.54|0.37|0.81
71915034|NCT01810380|143351011|SUPERIORITY_OR_OTHER||Least square mean difference|-4.1|STANDARD_ERROR_OF_MEAN|2.1||0.056|TWO_SIDED|95.0|-8.2|0.1||For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.|Mixed Models Analysis|Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions||The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.||0.1|-8.2|0.0560
71915035|NCT01810380|143351011|SUPERIORITY_OR_OTHER||Least square mean difference|-8.0|STANDARD_ERROR_OF_MEAN|2.1||0.0002|TWO_SIDED|95.0|-12.2|-3.9|||Mixed Models Analysis|||||-3.9|-12.2|0.0002
71915036|NCT03209362|143351100|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.5453|TWO_SIDED|95.0|-12.4|6.6|||ANCOVA|||||6.6|-12.4|0.5453
71872595|NCT03421431|143262788|SUPERIORITY||LS mean difference|-2.377||||0.6238|TWO_SIDED|95.0|-11.962|7.207|||ANCOVA|||||7.207|-11.962|0.6238
71915037|NCT03209362|143351101|SUPERIORITY||Least Squares Mean Difference|-3.5||||0.5386|TWO_SIDED|95.0|-14.9|7.8|||Longitudinal model|||Week 12||7.8|-14.9|0.5386
71915038|NCT03209362|143351101|SUPERIORITY||Least Squares Mean Difference|-3.3||||0.5873|TWO_SIDED|95.0|-15.2|8.6|||Longitudinal model|||Week 26||8.6|-15.2|0.5873
71915039|NCT03209362|143351102|SUPERIORITY||Least Squares Mean Difference|-2.9||||0.6347|TWO_SIDED|95.0|-15.0|9.2|||Longitudinal model|||Week 12||9.2|-15.0|0.6347
71915040|NCT03209362|143351102|SUPERIORITY||Least Squares Mean Difference|-1.8||||0.7806|TWO_SIDED|95.0|-14.3|10.8|||Longitudinal model|||Week 26||10.8|-14.3|0.7806
71915041|NCT03209362|143351103|SUPERIORITY||Least Squares Mean Difference|-0.9||||0.8819|TWO_SIDED|95.0|-13.2|11.4|||Longitudinal model|||Week 12||11.4|-13.2|0.8819
71872596|NCT03421431|143262788|SUPERIORITY||LS mean difference|-1.346||||0.7367|TWO_SIDED|95.0|-9.268|6.576|||ANCOVA|||||6.576|-9.268|0.7367
71915042|NCT03209362|143351103|SUPERIORITY||Least Squares Mean Difference|-5.6||||0.3796|TWO_SIDED|95.0|-18.3|7.1|||Longitudinal model|||Week 26||7.1|-18.3|0.3796
71915043|NCT03209362|143351104|SUPERIORITY||Least Squares Mean Difference|-3.0||||0.6217|TWO_SIDED|95.0|-14.9|9.0|||Longitudinal model|||Week 12||9.0|-14.9|0.6217
71915044|NCT03209362|143351104|SUPERIORITY||Least Squares Mean Difference|-2.5||||0.6901|TWO_SIDED|95.0|-14.8|9.8|||Longitudinal model|||Week 26||9.8|-14.8|0.6901
71915045|NCT00323427|143351119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|STANDARD_ERROR_OF_MEAN|0.0974||0.69|TWO_SIDED|95.0|-0.15|0.23||No multiple testing adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.23|-0.15|0.69
71915046|NCT00323427|143351120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14||0.42|TWO_SIDED|95.0|-0.16|0.38||No adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)||0.38|-0.16|0.42
71915047|NCT00323427|143351121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.15||0.97|TWO_SIDED|95.0|-0.3|0.29||No adjustment|t-test, 2 sided|||H0: mean(Arm 1) = Mean (Arm 2)||0.29|-0.30|0.97
71915048|NCT03039192|143351126|SUPERIORITY||Difference of Least Square Means|-3.8|STANDARD_ERROR_OF_MEAN|1.39||0.006|TWO_SIDED|95.0|-6.56|-1.09|||ANCOVA|||||-1.09|-6.56|0.006
71915049|NCT02493868|143351149|SUPERIORITY||Hazard Ratio (HR)|0.49|||=|0.003|TWO_SIDED|95.0|0.29|0.84|||Weighted Log-rank|||||0.84|0.29|= 0.003
71915050|NCT02407236|143351167|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|95.0|5.7|14.9|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||14.9|5.7|< 0.001
71872597|NCT03421431|143262789|SUPERIORITY||LS mean difference|-0.407||||0.8302|TWO_SIDED|95.0|-4.287|3.474|||ANCOVA|||||3.474|-4.287|0.8302
71872598|NCT03421431|143262789|SUPERIORITY||LS mean difference|-1.28||||0.5053|TWO_SIDED|95.0|-5.192|2.632|||ANCOVA|||||2.632|-5.192|0.5053
71872599|NCT03421431|143262789|SUPERIORITY||LS mean difference|0.873||||0.476|TWO_SIDED|95.0|-1.62|3.366|||ANCOVA|||||3.366|-1.620|0.4760
71872600|NCT03421431|143262790|SUPERIORITY||LS mean difference|-5.91||||0.0639|TWO_SIDED|95.0|-12.171|0.351|||ANCOVA|||||0.351|-12.171|0.0639
71872601|NCT03421431|143262790|SUPERIORITY||LS mean difference|-2.064||||0.4884|TWO_SIDED|95.0|-7.971|3.843|||ANCOVA|||||3.843|-7.971|0.4884
71872602|NCT03421431|143262790|SUPERIORITY||LS mean difference|-3.846||||0.1532|TWO_SIDED|95.0|-9.156|1.464|||ANCOVA|||||1.464|-9.156|0.1532
71872603|NCT03421431|143262791|SUPERIORITY||LS mean difference|-0.46||||0.0811|TWO_SIDED|95.0|-0.978|0.058|||ANCOVA|||||0.058|-0.978|0.0811
71915051|NCT02407236|143351167|SUPERIORITY||Adjusted treatment difference|10.2|||<|0.001|TWO_SIDED|95.0|5.6|14.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||14.8|5.6|< 0.001
71915052|NCT02407236|143351168|SUPERIORITY||Adjusted treatment difference|10.3|||<|0.001|TWO_SIDED|97.5|4.8|15.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1||15.8|4.8|< 0.001
71915053|NCT02407236|143351168|SUPERIORITY||Adjusted treatment difference|12.7|||<|0.001|TWO_SIDED|97.5|7.0|18.4|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2||18.4|7.0|< 0.001
71915054|NCT02407236|143351169|SUPERIORITY||Adjusted treatment difference|14.5||||0.002|TWO_SIDED|95.0|5.5|23.6|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||23.6|5.5|0.002
71915055|NCT02407236|143351169|SUPERIORITY||Adjusted treatment difference|19.7|||<|0.001|TWO_SIDED|95.0|10.3|29.0|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||29.0|10.3|< 0.001
71915056|NCT02407236|143351170|SUPERIORITY||Adjusted treatment difference|15.1||||0.002|TWO_SIDED|95.0|6.0|24.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1||24.2|6.0|0.002
71915057|NCT02407236|143351170|SUPERIORITY||Adjusted treatment difference|17.9|||<|0.001|TWO_SIDED|95.0|8.6|27.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2||27.2|8.6|< 0.001
71915058|NCT04984876|143351255|OTHER||Odds Ratio (OR)|25.83||||0.002|TWO_SIDED|95.0|4.34|506.78|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||506.78|4.34|0.002
71683227|NCT01492101|142884685|EQUIVALENCE|\[13\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|8.6||||0.0009|TWO_SIDED|95.0|3.57|13.72|||F-test|||||13.72|3.57|0.0009
71915059|NCT04984876|143351255|OTHER||Odds Ratio (OR)|5.1||||0.073|TWO_SIDED|95.0|0.8|100.98|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||100.98|0.80|0.073
71872604|NCT03421431|143262791|SUPERIORITY||LS mean difference|0.117||||0.6312|TWO_SIDED|95.0|-0.367|0.601|||ANCOVA|||||0.601|-0.367|0.6312
71872605|NCT03421431|143262791|SUPERIORITY||LS mean difference|-0.577||||0.0099|TWO_SIDED|95.0|-1.011|-0.143|||ANCOVA|||||-0.143|-1.011|0.0099
71872606|NCT03421431|143262804|SUPERIORITY||LS mean difference|1.356||||0.112|TWO_SIDED|95.0|-0.322|3.034|||ANCOVA|||||3.034|-0.322|0.1120
71872607|NCT03421431|143262804|SUPERIORITY||LS mean difference|0.647||||0.4229|TWO_SIDED|95.0|-0.947|2.24|||ANCOVA|||||2.240|-0.947|0.4229
71872608|NCT03421431|143262804|SUPERIORITY||LS mean difference|0.71||||0.2764|TWO_SIDED|95.0|-0.577|1.996|||ANCOVA|||||1.996|-0.577|0.2764
71872609|NCT03421431|143262805|SUPERIORITY||LS mean difference|0.008||||0.5606|TWO_SIDED|95.0|-0.02|0.037|||ANCOVA|||||0.037|-0.020|0.5606
71872610|NCT03421431|143262805|SUPERIORITY||LS mean difference|0.023||||0.1002|TWO_SIDED|95.0|-0.004|0.05|||ANCOVA|||||0.050|-0.004|0.1002
71872611|NCT03421431|143262805|SUPERIORITY||LS mean difference|-0.014||||0.2002|TWO_SIDED|95.0|-0.036|0.008|||ANCOVA|||||0.008|-0.036|0.2002
71872612|NCT03421431|143262806|SUPERIORITY||LS mean difference|-178.787||||0.7014|TWO_SIDED|95.0|-1098.454|740.88|||ANCOVA|||||740.880|-1098.454|0.7014
71872613|NCT03421431|143262806|SUPERIORITY||LS mean difference|52.307||||0.907|TWO_SIDED|95.0|-830.934|935.547|||ANCOVA|||||935.547|-830.934|0.9070
71915060|NCT04984876|143351256|OTHER||Odds Ratio (OR)|9.86||||0.018|TWO_SIDED|95.0|1.69|188.85|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||188.85|1.69|0.018
71915061|NCT04984876|143351256|OTHER||Odds Ratio (OR)|3.02||||0.164|TWO_SIDED|95.0|0.45|59.93|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||59.93|0.45|0.164
71915062|NCT04984876|143351257|OTHER||Odds Ratio (OR)|3.47||||0.138|TWO_SIDED|95.0|0.51|70.08|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||70.08|0.51|0.138
71915063|NCT04984876|143351257|OTHER||Odds Ratio (OR)|2.21||||0.247|TWO_SIDED|95.0|0.3|45.56|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||45.56|0.30|0.247
71872614|NCT03421431|143262806|SUPERIORITY||LS mean difference|-231.094||||0.536|TWO_SIDED|95.0|-967.273|505.086|||ANCOVA|||||505.086|-967.273|0.5360
71872615|NCT03421431|143262807|SUPERIORITY||LS mean difference|-753.153||||0.2985|TWO_SIDED|95.0|-2183.92|677.614|||ANCOVA|||||677.614|-2183.920|0.2985
71872616|NCT03421431|143262807|SUPERIORITY||LS mean difference|139.107||||0.8413|TWO_SIDED|95.0|-1236.689|1514.902|||ANCOVA|||||1514.902|-1236.689|0.8413
71872617|NCT03421431|143262807|SUPERIORITY||LS mean difference|-892.26||||0.1168|TWO_SIDED|95.0|-2011.705|227.186|||ANCOVA|||||227.186|-2011.705|0.1168
71872618|NCT03421431|143262808|SUPERIORITY||LS mean difference|33.491|||<|0.0001|TWO_SIDED|95.0|17.984|48.998|||ANCOVA|||||48.998|17.984|<0.0001
71915064|NCT04984876|143351258|OTHER||Odds Ratio (OR)|10.59|||<|0.001|TWO_SIDED|95.0|3.63|31.56|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||31.56|3.63|<0.001
71915065|NCT04984876|143351258|OTHER||Odds Ratio (OR)|5.05||||0.001|TWO_SIDED|95.0|1.8|14.36|||proportional odds model||proportional odds model adjusting for treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), log transformed baseline total IgE at screening and region.|||14.36|1.80|0.001
71915066|NCT04984876|143351259|OTHER||Odds Ratio (OR)|4.73||||0.082|TWO_SIDED|95.0|0.74|93.16|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||93.16|0.74|0.082
71915067|NCT04984876|143351259|OTHER||Odds Ratio (OR)|0.61||||0.632|TWO_SIDED|95.0|0.02|16.43|||Regression, Logistic||logistic regression model, including treatment, age subgroup (12 - 17 yrs, 18 - 55 yrs), region as fixed class effects, as well as and log-transformed baseline total IgE at screening and log-transformed MTD at screening DBPCFC as covariates.|||16.43|0.02|0.632
71915068|NCT04984876|143351264|OTHER||LS Mean difference|-3.77|||<|0.001|TWO_SIDED|95.0|-5.15|-2.4|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.40|-5.15|<0.001
71915069|NCT04984876|143351264|OTHER||LS Mean difference|-4.93|||<|0.001|TWO_SIDED|95.0|-7.77|-2.09|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-2.09|-7.77|<0.001
71915070|NCT04984876|143351264|OTHER||LS Mean difference|-3.2||||0.015|TWO_SIDED|95.0|-6.08|-0.32|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||-0.32|-6.08|0.015
71915071|NCT04984876|143351264|OTHER||LS Mean difference|-1.68||||0.13|TWO_SIDED|95.0|-4.62|1.25|||ANCOVA||ANCOVA model with treatment group, age subgroup (12 - 17 years, 18 - 55 years), region, log-transformed baseline total IgE at screening and baseline SPT mean wheal diameter (average dilutions peanut protein) as covariates.|||1.25|-4.62|0.130
71915072|NCT04984876|143351265|OTHER||LS Mean difference|-0.33||||0.173|TWO_SIDED|95.0|-1.03|0.36|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.36|-1.03|0.173
71915073|NCT04984876|143351265|OTHER||LS Mean difference|-0.29||||0.202|TWO_SIDED|95.0|-0.96|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.39|-0.96|0.202
71915074|NCT04984876|143351265|OTHER||LS Mean difference|-0.37||||0.151|TWO_SIDED|95.0|-1.09|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.34|-1.09|0.151
71915075|NCT04984876|143351265|OTHER||LS Mean difference|-0.23||||0.264|TWO_SIDED|95.0|-0.94|0.49|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.49|-0.94|0.264
71915076|NCT04984876|143351265|OTHER||LS Mean difference|-0.43||||0.123|TWO_SIDED|95.0|-1.16|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.30|-1.16|0.123
71915077|NCT04984876|143351265|OTHER||LS Mean difference|-0.23||||0.258|TWO_SIDED|95.0|-0.94|0.47|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.47|-0.94|0.258
71915078|NCT04984876|143351265|OTHER||LS Mean difference|-0.17||||0.324|TWO_SIDED|95.0|-0.92|0.58|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.58|-0.92|0.324
71872619|NCT03421431|143262808|SUPERIORITY||LS mean difference|30.814|||<|0.0001|TWO_SIDED|95.0|15.802|45.825|||ANCOVA|||||45.825|15.802|<0.0001
71872620|NCT03421431|143262808|SUPERIORITY||LS mean difference|2.677||||0.6757|TWO_SIDED|95.0|-9.946|15.3|||ANCOVA|||||15.300|-9.946|0.6757
71872621|NCT03421431|143262809|SUPERIORITY||LS mean difference|21.3||||0.0134|TWO_SIDED|95.0|4.533|38.067|||ANCOVA|||||38.067|4.533|0.0134
71872622|NCT03421431|143262809|SUPERIORITY||LS mean difference|5.847||||0.4686|TWO_SIDED|95.0|-10.116|21.811|||ANCOVA|||||21.811|-10.116|0.4686
71872623|NCT03421431|143262809|SUPERIORITY||LS mean difference|15.453||||0.0181|TWO_SIDED|95.0|2.699|28.206|||ANCOVA|||||28.206|2.699|0.0181
71915079|NCT04984876|143351265|OTHER||LS Mean difference|-0.03||||0.473|TWO_SIDED|95.0|-0.78|0.73|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.73|-0.78|0.473
71915080|NCT04984876|143351266|OTHER||LS Mean difference|0.06||||0.597|TWO_SIDED|95.0|-0.44|0.57|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.57|-0.44|0.597
71915081|NCT04984876|143351266|OTHER||LS Mean difference|-0.39||||0.064|TWO_SIDED|95.0|-0.89|0.11|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.11|-0.89|0.064
71915082|NCT04984876|143351266|OTHER||LS Mean difference|-0.22||||0.191|TWO_SIDED|95.0|-0.72|0.28|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.28|-0.72|0.191
71915083|NCT04984876|143351266|OTHER||LS Mean difference|-0.02||||0.472|TWO_SIDED|95.0|-0.51|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 1 - Total Score||0.48|-0.51|0.472
71872624|NCT03421431|143262810|SUPERIORITY||LS mean difference|4.324||||0.0557|TWO_SIDED|95.0|-0.108|8.756|||ANCOVA|||||8.756|-0.108|0.0557
71872625|NCT03421431|143262810|SUPERIORITY||LS mean difference|2.305||||0.2867|TWO_SIDED|95.0|-1.955|6.566|||ANCOVA|||||6.566|-1.955|0.2867
71872626|NCT03421431|143262810|SUPERIORITY||LS mean difference|2.019||||0.2437|TWO_SIDED|95.0|-1.39|5.429|||ANCOVA|||||5.429|-1.390|0.2437
71872627|NCT03421431|143262811|SUPERIORITY||LS mean difference|0.019||||0.9913|TWO_SIDED|95.0|-3.491|3.53|||ANCOVA|||||3.530|-3.491|0.9913
71872628|NCT03421431|143262811|SUPERIORITY||LS mean difference|0.995||||0.553|TWO_SIDED|95.0|-2.323|4.314|||ANCOVA|||||4.314|-2.323|0.5530
71872629|NCT03421431|143262811|SUPERIORITY||LS mean difference|-0.976||||0.4729|TWO_SIDED|95.0|-3.665|1.713|||ANCOVA|||||1.713|-3.665|0.4729
71872630|NCT04147650|143262817|SUPERIORITY||Odds Ratio (OR)|2.18||||0.1352|TWO_SIDED|95.0|0.62|7.62|||Regression, Logistic|||0.05 % VOS versus vehicle||7.62|0.62|0.1352
71872631|NCT04147650|143262817|SUPERIORITY||Odds Ratio (OR)|1.78||||0.2823|TWO_SIDED|95.0|0.49|6.45|||Regression, Logistic|||0.10% VOS versus vehicle||6.45|0.49|0.2823
71872632|NCT04147650|143262817|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0889|TWO_SIDED|95.0|0.7|8.3|||Regression, Logistic|||0.20% VOS versus vehicle||8.30|0.70|0.0889
71872633|NCT04147650|143262818|SUPERIORITY||Least square mean difference|-2.6||||0.3604|TWO_SIDED|95.0|-9.6|4.3|||ANCOVA|||0.05% VOS versus vehicle||4.3|-9.6|0.3604
71872634|NCT04147650|143262818|SUPERIORITY||Least square mean difference|-2.6||||0.3737|TWO_SIDED|95.0|-9.6|4.4|||ANCOVA|||0.10% VOS versus vehicle||4.4|-9.6|0.3737
71872635|NCT04147650|143262818|SUPERIORITY||Least square mean difference|1.8||||0.5307|TWO_SIDED|95.0|-5.1|8.6|||ANCOVA|||0.20% VOS versus vehicle||8.6|-5.1|0.5307
71872636|NCT01128738|143262837|SUPERIORITY_OR_OTHER||Percentage difference|50.2|||<|0.001|TWO_SIDED|95.0|38.1|62.3|||Fisher Exact||Percentage difference was estimated as BTX 50 U minus placebo.|||62.3|38.1|<0.001
71872637|NCT01178671|143262885|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED||||||Mixed Models Analysis|||||||0.17
71872638|NCT01178671|143262886|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
71872639|NCT01178671|143262887|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||t-test, 2 sided|||||||.14
71872640|NCT01178671|143262888|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||.50
71872641|NCT01178671|143262889|SUPERIORITY_OR_OTHER|||||||0.023|TWO_SIDED||||||Mixed Models Analysis|||||||0.023
71872642|NCT01178671|143262890|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.31|TWO_SIDED||||||Mixed Models Analysis|||||||0.31
71872643|NCT01178671|143262891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7||||0.042|TWO_SIDED|95.0|1.1|19.9|||Mixed Models Analysis|||||19.9|1.1|0.042
71872644|NCT01178671|143262892|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
71872645|NCT01178671|143262893|SUPERIORITY_OR_OTHER|||||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
71872646|NCT01178671|143262894|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||Mixed Models Analysis|||||||0.65
71872647|NCT01211197|143262900|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.59|STANDARD_DEVIATION|7.6|||TWO_SIDED|90.0|95.75|105.67|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Ratio calculated as FDC fasted divided by individual tablets fasted.||105.67|95.75|
71872648|NCT01211197|143262900|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.94|STANDARD_DEVIATION|8.0|||TWO_SIDED|90.0|89.85|100.33|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||100.33|89.85|
71872649|NCT01211197|143262901|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|99.31|STANDARD_DEVIATION|12.2|||TWO_SIDED|90.0|91.76|107.49|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||107.49|91.76|
71872650|NCT01211197|143262901|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|64.3|STANDARD_DEVIATION|20.6|||TWO_SIDED|90.0|55.97|73.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||73.87|55.97|
71872651|NCT01211197|143262902|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.94|STANDARD_DEVIATION|7.7|||TWO_SIDED|90.0|96.03|106.11|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||106.11|96.03|
71872652|NCT01211197|143262902|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.39|STANDARD_DEVIATION|8.2|||TWO_SIDED|90.0|89.22|99.87|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||99.87|89.22|
71872653|NCT01211197|143262903|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.13|STANDARD_DEVIATION|11.7|||TWO_SIDED|90.0|95.59|111.25|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.25|95.59|
71872654|NCT01211197|143262903|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|96.96|STANDARD_DEVIATION|15.5|||TWO_SIDED|90.0|87.23|107.78|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||107.78|87.23|
71872655|NCT01211197|143262904|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|102.15|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|93.87|111.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||111.15|93.87|
71915084|NCT04984876|143351266|OTHER||LS Mean difference|0.03||||0.537|TWO_SIDED|95.0|-0.57|0.62|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.62|-0.57|0.537
71915085|NCT04984876|143351266|OTHER||LS Mean difference|-0.32||||0.141|TWO_SIDED|95.0|-0.91|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.27|-0.91|0.141
71915086|NCT04984876|143351266|OTHER||LS Meand difference|-0.45||||0.063|TWO_SIDED|95.0|-1.04|0.13|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.13|-1.04|0.063
71915087|NCT04984876|143351266|OTHER||LS Mean difference|-0.1||||0.368|TWO_SIDED|95.0|-0.68|0.48|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAQLQ) and region as fixed effects and log-transformed total IgE at screening as a covariate|Week 12 Part 2 - Total Score||0.48|-0.68|0.368
71915088|NCT04984876|143351267|OTHER||LS Mean difference|-0.24||||0.225|TWO_SIDED|95.0|-0.87|0.39|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.39|-0.87|0.225
71915089|NCT04984876|143351267|OTHER||LS Mean difference|-0.32||||0.153|TWO_SIDED|95.0|-0.93|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.30|-0.93|0.153
71915090|NCT04984876|143351267|OTHER||LS Mean difference|-0.3||||0.179|TWO_SIDED|95.0|-0.95|0.34|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.34|-0.95|0.179
71872656|NCT01211197|143262904|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.67|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|91.7|110.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||110.51|91.70|
71872657|NCT01211197|143262905|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.49|STANDARD_DEVIATION|12.7|||TWO_SIDED|90.0|95.3|112.39|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted||112.39|95.30|
71872658|NCT01211197|143262905|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|75.13|STANDARD_DEVIATION|24.5|||TWO_SIDED|90.0|63.68|88.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted||88.64|63.68|
71915091|NCT04984876|143351267|OTHER||LS Mean difference|0.11||||0.631|TWO_SIDED|95.0|-0.55|0.77|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.77|-0.55|0.631
71915092|NCT04984876|143351267|OTHER||LS Mean difference|-0.52||||0.06|TWO_SIDED|95.0|-1.18|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-1.18|0.060
71915093|NCT04984876|143351267|OTHER||LS Mean difference|-0.08||||0.404|TWO_SIDED|95.0|-0.72|0.56|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.56|-0.72|0.404
71915094|NCT04984876|143351267|OTHER||LS Mean difference|-0.38||||0.135|TWO_SIDED|95.0|-1.06|0.3|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.30|-1.06|0.135
71683228|NCT01492101|142884685|EQUIVALENCE|\[14\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.8||||0.2337|TWO_SIDED|95.0|-7.35|1.8|||F-test|||||1.8|-7.35|0.2337
71915095|NCT04984876|143351267|OTHER||LS Mean difference|0.01||||0.514|TWO_SIDED|95.0|-0.7|0.72|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.72|-0.70|0.514
71915096|NCT04984876|143351268|OTHER||LS Mean difference|0.04||||0.574|TWO_SIDED|95.0|-0.42|0.51|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.51|-0.42|0.574
71915097|NCT04984876|143351268|OTHER||LS Mean difference|-0.37||||0.056|TWO_SIDED|95.0|-0.83|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.09|-0.83|0.056
71915098|NCT04984876|143351268|OTHER||LS Mean difference|-0.36||||0.069|TWO_SIDED|95.0|-0.83|0.12|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.12|-0.83|0.069
71915099|NCT04984876|143351268|OTHER||LS Mean difference|-0.19||||0.205|TWO_SIDED|95.0|-0.65|0.27|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 1 - Total Score||0.27|-0.65|0.205
71915100|NCT04984876|143351268|OTHER||LS Mean difference|-0.2||||0.248|TWO_SIDED|95.0|-0.76|0.37|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.37|-0.76|0.248
71872659|NCT02349451|143262913|SUPERIORITY||response rate difference|39.8|||<|0.001|TWO_SIDED|95.0|17.2|57.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||57.7|17.2|<0.001
71872660|NCT02349451|143262913|SUPERIORITY||response rate difference|50.3|||<|0.001|TWO_SIDED|95.0|28.1|67.4||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact|||||67.4|28.1|<0.001
71683229|NCT01492101|142884685|EQUIVALENCE|\[15\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|10.3|||<|0.0001|TWO_SIDED|95.0|6.6|13.98|||F-test|||||13.98|6.6|<0.0001
71683230|NCT01492101|142884685|EQUIVALENCE|\[16\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.0||||0.99|TWO_SIDED|95.0|-3.74|3.69|||F-test|||||3.69|-3.74|0.99
71683231|NCT01492101|142884687|EQUIVALENCE|\[17\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|0.9||||0.5833|TWO_SIDED|95.0|-2.42|4.29|||F-test|||||4.29|-2.42|0.5833
71915101|NCT04984876|143351268|OTHER||LS Mean difference|-0.42||||0.071|TWO_SIDED|95.0|-0.98|0.14|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.14|-0.98|0.071
71915102|NCT04984876|143351268|OTHER||LS Mean difference|-0.49||||0.048|TWO_SIDED|95.0|-1.06|0.09|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.09|-1.06|0.048
71915103|NCT04984876|143351268|OTHER||LS Mean difference|-0.3||||0.142|TWO_SIDED|95.0|-0.85|0.25|||ANCOVA||ANCOVA with treatment group, baseline PRO scores (FAIM) and region as fixed effects and log-transformed total IgE at screening as a covariate.|Week 12 Part 2 - Total Score||0.25|-0.85|0.142
71915104|NCT01193049|143351274|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.25||||0.001|TWO_SIDED|90.0|0.14|0.46||1-sided p-value, α = 0.05|ANOVA|||GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.46|0.14|0.001
71915105|NCT01193049|143351274|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.2|||<|0.001|TWO_SIDED|90.0|0.13|0.3||1-sided p value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.||0.30|0.13|<0.001
71915106|NCT01193049|143351274|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|0.2||||0.553||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.||||0.553
71915107|NCT01193049|143351274|SUPERIORITY_OR_OTHER||Correlation FR from Placebo :SP vs NE|-0.02||||0.964||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.||||0.964
71915108|NCT01193049|143351275|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.27||||0.009|TWO_SIDED|90.0|0.12|0.62||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.||0.62|0.12|0.009
71915109|NCT01193049|143351275|SUPERIORITY_OR_OTHER||GM FR from Placebo : NE|0.31|||<|0.001|TWO_SIDED|90.0|0.22|0.43||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.||0.43|0.22|<0.001
71915110|NCT01193049|143351275|SUPERIORITY_OR_OTHER||Correlation FC from BL: SP vs NE|-0.02||||0.962||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.||||0.962
71915111|NCT01193049|143351275|SUPERIORITY_OR_OTHER||Correlation FR from Placebo: SP vs NE|0.07||||0.83||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.||||0.83
71915112|NCT01193049|143351276|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.8||||0.258|TWO_SIDED|90.0|0.43|1.47||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.47|0.43|0.258
71915113|NCT01193049|143351276|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|1.08||||0.681|TWO_SIDED|90.0|0.8|1.46||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||1.46|0.80|0.681
71915114|NCT01193049|143351277|SUPERIORITY_OR_OTHER||GM FR from Placebo:SP|0.61||||0.117|TWO_SIDED|90.0|0.3|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.||1.24|0.30|0.117
71915115|NCT01193049|143351277|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.64||||0.011|TWO_SIDED|90.0|0.47|0.86||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.||0.86|0.47|0.011
71915116|NCT01193049|143351279|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-5|1.51||||0.01|TWO_SIDED|90.0|1.15|1.99||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.||1.99|1.15|0.010
71915117|NCT01193049|143351279|SUPERIORITY_OR_OTHER||GM FR from Placebo: IL-13|1.35||||0.02|TWO_SIDED|90.0|1.07|1.71||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.||1.71|1.07|0.020
71915118|NCT01193049|143351280|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.82||||0.119|TWO_SIDED|90.0|0.62|1.09||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.||1.09|0.62|0.119
71915119|NCT01193049|143351280|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.68||||0.103|TWO_SIDED|90.0|0.41|1.14||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.||1.14|0.41|0.103
71915120|NCT01193049|143351281|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.6||||0.003|TWO_SIDED|90.0|0.46|0.77||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.||0.77|0.46|0.003
71915121|NCT01193049|143351281|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.49||||0.036|TWO_SIDED|90.0|0.26|0.93||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.||0.93|0.26|0.036
71915122|NCT01193049|143351282|SUPERIORITY_OR_OTHER||GM FR from Placebo: SP|0.7||||0.143|TWO_SIDED|90.0|0.4|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.||1.24|0.40|0.143
71915123|NCT01193049|143351282|SUPERIORITY_OR_OTHER||GM FR from Placebo: NE|0.61||||0.056|TWO_SIDED|90.0|0.37|1.02||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.||1.02|0.37|0.056
71915124|NCT01462045|143351287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|5.7|<|0.01|TWO_SIDED|95.0|-25.6|-1.6|||t-test, 2 sided|||||-1.6|-25.6|<0.01
71683232|NCT01492101|142884687|EQUIVALENCE|\[18\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.3||||0.3098|TWO_SIDED|95.0|-1.24|3.9|||F-test|||||3.9|-1.24|0.3098
71915125|NCT01462045|143351288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8|STANDARD_ERROR_OF_MEAN|2.4|<|0.01|TWO_SIDED|95.0|0.83|10.8|||t-test, 2 sided|||||10.8|0.83|<0.01
71915126|NCT02436915|143351293|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TUG (i.e., greater percent decrease of time to complete TUG from baseline to follow ups) as compared to the sham tDCS.||||||0.24|||||||ANOVA|||||||0.24
71915127|NCT02436915|143351294|EQUIVALENCE|We hypothesized that the real tDCS would improve the MoCA score (i.e., greater percent increase decrease of MoCA score from baseline to follow ups) as compared to the sham tDCS.||||||0.03|||||||ANOVA|||||||0.03
71915128|NCT02436915|143351295|EQUIVALENCE|We hypothesized that the real tDCS would improve the dual task performance of walking (i.e., greater percent decrease of dual task cost to walking speed from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
71915129|NCT02436915|143351296|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing sway speed from baseline to follow ups) as compared to the sham tDCS.||||||0.004|||||||ANOVA|||||||0.004
71915130|NCT02436915|143351297|EQUIVALENCE|We hypothesized that the real tDCS would reduce the depression (i.e., greater percent decrease of GDS score from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA|||||||0.37
71915131|NCT02436915|143351298|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of TMT (i.e., greater percent decrease of time to complete TMT from baseline to follow ups) as compared to the sham tDCS.||||||0.54|||||||ANOVA|||||||0.54
71915132|NCT02436915|143351299|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing postural sway area from baseline to follow ups) as compared to the sham tDCS.||||||0.0007|||||||ANOVA|||||||0.0007
71915133|NCT02436915|143351300|EQUIVALENCE|We hypothesized that the real tDCS would improve the performance of walking (i.e., greater percent decrease of dual task cost to stride time from baseline to follow ups) as compared to the sham tDCS.||||||0.04|||||||ANOVA|||||||0.04
71915134|NCT02579863|143351312|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.33475|TWO_SIDED|95.0|0.56|1.45|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III).|||1.45|0.56|0.33475
71915135|NCT02579863|143351313|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.83416|TWO_SIDED|95.0|0.81|1.84|||Stratified log-rank test||"Based on Cox regression model with treatment as a covariate stratified by Age (\<75 years vs \>= 75 years) and ISS stage (I or II vs. III)."|||1.84|0.81|0.83416
71915136|NCT02579863|143351314|SUPERIORITY||Difference in % vs SOC|5.8||||0.13102|TWO_SIDED|95.0|-4.3|15.8|||One-sided p-value for testing|H0: difference in % =0 versus H1: difference in % \> 0.|||Based on Miettinen \& Nurminen method stratified by 'Age' (\<75 years vs \>= 75 years) and 'ISS stage' (I or II vs. III); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|15.8|-4.3|0.13102
71915137|NCT03531762|143351341|OTHER||Ratio of Geometric Least Square Mean|108.87|||||TWO_SIDED|90.0|101.2|117.13||||||||117.13|101.20|
71915138|NCT03531762|143351342|OTHER||Ratio of Geometric Least Square Mean|109.8|||||TWO_SIDED|90.0|101.69|118.55||||||||118.55|101.69|
71915139|NCT03531762|143351343|OTHER||Ratio of Geometric Least Square Mean|104.1|||||TWO_SIDED|90.0|92.93|116.61||||||||116.61|92.93|
71915140|NCT00364832|143351371|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.81|||||TWO_SIDED|90.0|0.73|0.9|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ week (0.4, 0.8 and 1.2 dose group)||0.90|0.73|
71915141|NCT00364832|143351371|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.72|||||TWO_SIDED|90.0|0.55|0.86|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 3 weeks (0.4, 0.8 and 1.2 dose group)||0.86|0.55|
71872661|NCT02349451|143262914|SUPERIORITY||response rate difference|-3.3||||0.723|TWO_SIDED|95.0|-18.5|12.1||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||12.1|-18.5|0.723
71872662|NCT02349451|143262914|SUPERIORITY||response rate difference|7.3||||0.215|TWO_SIDED|95.0|-7.4|21.6||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||21.6|-7.4|0.215
71872663|NCT02349451|143262915|SUPERIORITY||response rate difference|24.1||||0.021|TWO_SIDED|95.0|3.9|39.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.3|3.9|0.021
71872664|NCT02349451|143262915|SUPERIORITY||response rate difference|-0.9||||0.611|TWO_SIDED|95.0|-16.5|14.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||14.8|-16.5|0.611
71872665|NCT02349451|143262915|SUPERIORITY||response rate difference|40.9|||<|0.001|TWO_SIDED|95.0|20.1|55.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||55.8|20.1|<0.001
71872666|NCT02349451|143262915|SUPERIORITY||response rate difference|15.9||||0.039|TWO_SIDED|95.0|-0.3|31.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||31.3|-0.3|0.039
71872667|NCT02349451|143262916|SUPERIORITY||response rate difference|18.4||||0.034|TWO_SIDED|95.0|1.5|29.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||29.7|1.5|0.034
71872668|NCT02349451|143262916|SUPERIORITY||response rate difference|7.3||||0.185|TWO_SIDED|95.0|-5.8|19.9||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||19.9|-5.8|0.185
71872669|NCT02349451|143262916|SUPERIORITY||response rate difference|27.3||||0.004|TWO_SIDED|95.0|9.6|39.0||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact|||||39.0|9.6|0.004
71872670|NCT02349451|143262916|SUPERIORITY||response rate difference|16.2||||0.017|TWO_SIDED|95.0|2.3|29.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact|||||29.3|2.3|0.017
71872671|NCT02349451|143262917|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
71915142|NCT00364832|143351371|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.93|||||TWO_SIDED|90.0|0.81|1.09|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group)||1.09|0.81|
71915143|NCT00762528|143351378|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71872672|NCT02349451|143262917|SUPERIORITY|||||||0.561||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.561
71872673|NCT02349451|143262917|SUPERIORITY||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test|||||||<0.001
71872674|NCT02349451|143262917|SUPERIORITY|||||||0.106||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test|||||||0.106
71872675|NCT02349451|143262918|SUPERIORITY||Least squares mean difference|-1.07|||<|0.001|TWO_SIDED|95.0|-1.58|-0.57||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.57|-1.58|<0.001
71872676|NCT02349451|143262918|SUPERIORITY||Least squares mean difference|-0.13||||0.479|TWO_SIDED|95.0|-0.48|0.23||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.23|-0.48|0.479
71872677|NCT02349451|143262918|SUPERIORITY||Least squares mean difference|-1.4|||<|0.001|TWO_SIDED|95.0|-1.9|-0.89||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.89|-1.90|<0.001
71872678|NCT02349451|143262918|SUPERIORITY||Least squares mean difference|-0.45||||0.012|TWO_SIDED|95.0|-0.81|-0.1||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.10|-0.81|0.012
71872679|NCT02349451|143262919|SUPERIORITY||Least squares mean difference|-1.17|||<|0.001|TWO_SIDED|95.0|-1.81|-0.53||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.53|-1.81|<0.001
71872680|NCT02349451|143262919|SUPERIORITY||Least squares mean difference|-0.09||||0.696|TWO_SIDED|95.0|-0.54|0.36||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.36|-0.54|0.696
71872681|NCT02349451|143262919|SUPERIORITY||Least squares mean difference|-1.41|||<|0.001|TWO_SIDED|95.0|-2.04|-0.77||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.77|-2.04|<0.001
71872682|NCT02349451|143262919|SUPERIORITY||Least squares mean difference|-0.33||||0.151|TWO_SIDED|95.0|-0.77|0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.12|-0.77|0.151
71872683|NCT02349451|143262920|SUPERIORITY||Least squares mean difference|-3.17|||<|0.001|TWO_SIDED|95.0|-4.14|-2.19||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-2.19|-4.14|<0.001
71872684|NCT02349451|143262920|SUPERIORITY||Least squares mean difference|-0.81||||0.021|TWO_SIDED|95.0|-1.51|-0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-0.12|-1.51|0.021
71915144|NCT00762528|143351379|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71683233|NCT01492101|142884687|EQUIVALENCE|\[19\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|1.1||||0.6264|TWO_SIDED|95.0|-3.39|5.63|||F-test|||||5.63|-3.39|0.6264
71915145|NCT00762528|143351380|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71915146|NCT00762528|143351381|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71915147|NCT00762528|143351382|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71872685|NCT02349451|143262920|SUPERIORITY||Least squares mean difference|-2.73|||<|0.001|TWO_SIDED|95.0|-3.7|-1.75||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||-1.75|-3.70|<0.001
71872686|NCT02349451|143262920|SUPERIORITY||Least squares mean difference|-0.37||||0.288|TWO_SIDED|95.0|-1.06|0.32||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA|||||0.32|-1.06|0.288
71872687|NCT02683941|143262922|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.866|TWO_SIDED|95.0|0.48|1.95|||Log Rank|||The hazard ratio and the 95% confidence interval (CI) were estimated using a Cox proportional hazards model, stratified for interactive web response system (IWRS) tumour subtype (typical versus \[vs\] atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.95|0.48|0.866
71872688|NCT02683941|143262923|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.837|TWO_SIDED|95.0|0.48|1.88|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.88|0.48|0.837
71872689|NCT02683941|143262924|OTHER||Percentage difference|14.0|||||TWO_SIDED|95.0|-10.97|37.86||||||The treatment difference compares lanreotide to placebo (central review). The 95% exact unconditional CI was used for ORR difference.||37.86|-10.97|
71872690|NCT02683941|143262924|OTHER||Percentage difference|2.0|||||TWO_SIDED|95.0|-22.69|26.53||||||The treatment difference compares lanreotide to placebo (local review). The 95% exact unconditional CI was used for ORR difference.||26.53|-22.69|
71872691|NCT02683941|143262925|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.582|TWO_SIDED|95.0|0.5|1.5|||Log Rank|||The hazard ratio and the 95% CI were estimated using a Cox proportional hazards model, stratified for IWRS tumour subtype (typical vs atypical) using the exact method for ties. P-value of stratified log rank test comparing lanreotide to placebo with strata based on the IWRS tumour subtype (typical vs atypical) stratification factor.||1.50|0.50|0.582
71872692|NCT00892723|143262976|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.87
71872693|NCT00892723|143262976|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.86
71872694|NCT00892723|143262976|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.11
71872695|NCT00892723|143262976|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.91
71915148|NCT00762528|143351383|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71915149|NCT00762528|143351384|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71683234|NCT01492101|142884687|EQUIVALENCE|\[20\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.6||||0.0003|TWO_SIDED|95.0|-7.11|-2.1|||F-test|||||-2.1|-7.11|0.0003
71683235|NCT01492101|142884687|EQUIVALENCE|\[21\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-1.4||||0.2473|TWO_SIDED|95.0|-3.84|0.99|||F-test|||||0.99|-3.84|0.2473
71872696|NCT00892723|143262977|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
71872697|NCT00892723|143262977|SUPERIORITY_OR_OTHER|||||||0.82||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.82
71872698|NCT00892723|143262977|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.23
71872699|NCT00892723|143262977|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.71
71872700|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.73
71872701|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.94
71872702|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.14
71915150|NCT00762528|143351385|SUPERIORITY_OR_OTHER||||||<|0.05|ONE_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71915151|NCT02658149|143351392|OTHER|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||||||0.036
71915152|NCT02658149|143351393|OTHER|||||||0.204|||||||Wilcoxon (Mann-Whitney)|||||||0.204
71915153|NCT02658149|143351394|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71915154|NCT02658149|143351395|OTHER|||||||0.741|||||||t-test, 2 sided|||||||0.741
71915155|NCT02658149|143351396|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71915156|NCT03053401|143351403|OTHER|Test of difference was conducted.||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71915157|NCT03053401|143351404|OTHER|||||||0.762||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.762
71915158|NCT03053401|143351404|OTHER|||||||0.41||||||Alpha = 0.025 for multiple comparisons.|Wilcoxon Rank Sum Test with Exact Option|||||||0.410
71872703|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.68
71872704|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.56
71872705|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.32
71872706|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.33||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.33
71872707|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.65
71872708|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.21
71872709|NCT00892723|143262978|SUPERIORITY_OR_OTHER|||||||0.9||95.0|||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.||||||0.90
71872710|NCT00892723|143262979|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.||||||0.16
71872711|NCT00892723|143262979|SUPERIORITY_OR_OTHER|||||||0.74|TWO_SIDED|95.0||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)|||||||0.74
71872712|NCT00892723|143262979|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|||||||0.45
71872713|NCT00892723|143262979|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.079
71872714|NCT00892723|143262979|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.16
71872715|NCT00892723|143262979|SUPERIORITY_OR_OTHER|||||||0.45|TWO_SIDED|95.0||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|For this early phase study, no adjustments were used.||||||0.45
71872716|NCT00150969|143262980|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71872717|NCT00150969|143262987|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||t-test, 2 sided|||||||<0.05
71872718|NCT01313689|143263007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.2677|TWO_SIDED|95.0|0.5|1.24|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.24|0.50|0.2677
71872719|NCT01313689|143263007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0837|TWO_SIDED|95.0|0.19|1.53|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.53|0.19|0.0837
71872720|NCT01313689|143263008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.003|TWO_SIDED|95.0|0.35|0.87|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.|||0.87|0.35|0.0030
71872721|NCT01313689|143263008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49||||0.0262|TWO_SIDED|95.0|0.21|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.21|0.0262
71872722|NCT01313689|143263009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.942||||0.0223|TWO_SIDED|95.0|1.166|7.424|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||7.424|1.166|0.0223
71872723|NCT01313689|143263009|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|999.999||||0.9985|TWO_SIDED|95.0|0.001|999.999|||Regression, Logistic|conditional logistic regression with interval and pooled stratum||||999.999|0.001|0.9985
71872724|NCT01313689|143263010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.366||||0.4159|TWO_SIDED|95.0|0.644|2.899||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement|Regression, Logistic|||||2.899|0.644|0.4159
71872725|NCT01313689|143263010|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.225||||0.8866|TWO_SIDED|95.0|0.076|19.862||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement|Regression, Logistic|||||19.862|0.076|0.8866
71872726|NCT01313689|143263011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.1732|TWO_SIDED|95.0|0.48|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||1.17|0.48|0.1732
71872727|NCT01313689|143263011|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.8128|TWO_SIDED|95.0|0.46|2.68||P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Log Rank||Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum|||2.68|0.46|0.8128
71872728|NCT00406653|143263079|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.611|TWO_SIDED|95.0|0.6|2.4||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, \~10mg/kg, 30/\~10mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/\~10 mg/kg=45%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/\~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||2.4|0.6|0.611
71915159|NCT03053401|143351405|OTHER|Test of Difference conducted.||||||0.454|||||||t-test, 2 sided|||||||0.454
71915160|NCT01804842|143351411|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.7||||0.0018|TWO_SIDED|90.0|61.14|84.01|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.||84.01|61.14|0.0018
71872729|NCT00406653|143263082|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18|||||TWO_SIDED|95.0|0.4|3.44||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA mg/kg, \~10 mg/kg, 30/\~10 mg/kg). Only \~half intended number assigned to ABA 30/\~10 mg/kg arm and \~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=80%, sample size=134, 5% significance; expected PLA response rate= 15%, ABA/\~10 mg/kg=30%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/\~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA \~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/\~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata||3.44|0.4|
71872730|NCT00406653|143263083|SUPERIORITY_OR_OTHER|||||||0.436||95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.436
71872731|NCT00406653|143263090|SUPERIORITY_OR_OTHER|||||||0.112|TWO_SIDED|95.0||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.112
71872732|NCT01519466|143263143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_DEVIATION|2.32||0.0926|TWO_SIDED|95.0|-1.55|0.12|||t-test, 2 sided|||||0.12|-1.55|0.0926
71872733|NCT01519466|143263143|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_DEVIATION|2.97||||||||||||||||
71872734|NCT01519466|143263144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.49||0.3251|TWO_SIDED|95.0|-0.27|0.09|||t-test, 2 sided|||||0.09|-0.27|0.3251
71872735|NCT01519466|143263144|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_DEVIATION|0.51||||||||||||||||
71872736|NCT01519466|143263145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_DEVIATION|1.26||0.5798|TWO_SIDED|95.0|-0.33|0.58|||t-test, 2 sided|||Hyperglycaemia, glucose above 10mmol/l (180mg/dL)||0.58|-0.33|0.5798
71872737|NCT01519466|143263145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_DEVIATION|1.03||0.096|TWO_SIDED|95.0|-0.68|0.06|||t-test, 2 sided|||Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)||0.06|-0.68|0.0960
71872738|NCT01519466|143263145|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|STANDARD_DEVIATION|6.53||0.0007|TWO_SIDED|95.0|2.01|6.71|||t-test, 2 sided|||Treatment Satisfaction||6.71|2.01|0.0007
71872739|NCT00147823|143263147|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANOVA|Using baseline (6 wk) and two year post operative predicted effects data, and setting desirable power to detect our effects to 80%||The sample size provided at least 80% power at a 5% alpha level to detect a medium to large effect in patients receiving Vitoss alone compared to combination therapy consisting of Vitoss with Bone Marrow Aspirate. Since a random coefficients model was used to analyze the data, the sample size calculation was estimated under this model assuming a 3% attrition rate between all measurement times.||||<0.01
71872740|NCT00147823|143263148|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.01
71872741|NCT00561951|143263175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.002||95.0|-0.56|-0.13||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.13|-0.56|0.002
71683236|NCT01492101|142884687|EQUIVALENCE|\[22\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-2.9||||0.0333|TWO_SIDED|95.0|-5.54|-0.23|||F-test|||||-0.23|-5.54|0.0333
71872742|NCT00561951|143263175|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.6|-0.17||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.17|-0.60|<0.001
71915161|NCT01804842|143351411|SUPERIORITY_OR_OTHER||% Ratio of LS Means|71.5||||0.002|TWO_SIDED|90.0|60.85|84.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||84.09|60.85|0.0020
71915162|NCT01804842|143351411|SUPERIORITY_OR_OTHER||% Ratio of LS Means|99.8||||0.9844|TWO_SIDED|90.0|84.91|117.33|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||117.33|84.91|0.9844
71915163|NCT01804842|143351412|SUPERIORITY_OR_OTHER||% Ratio of LS Means|83.8||||0.1595|TWO_SIDED|90.0|68.1|103.23|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of LS means and the comparator for the p-values.||103.23|68.10|0.1595
71915164|NCT01804842|143351412|SUPERIORITY_OR_OTHER||% Ratio of LS Means|111.3||||0.3867|TWO_SIDED|90.0|90.37|136.99|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||136.99|90.37|0.3867
71872743|NCT00561951|143263177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.002||95.0|-0.91|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-0.91|0.002
71872744|NCT00561951|143263177|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||<|0.001||95.0|-1.01|-0.32|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.32|-1.01|<0.001
71872745|NCT00561951|143263179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.003||95.0|-1.07|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.22|-1.07|0.003
71872746|NCT00561951|143263179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.002||95.0|-1.09|-0.23|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.23|-1.09|0.002
71915165|NCT01804842|143351412|SUPERIORITY_OR_OTHER||% Ratio of LS Means|132.7||||0.0294|TWO_SIDED|90.0|107.78|163.39|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.||163.39|107.78|0.0294
71915166|NCT01804842|143351413|SUPERIORITY_OR_OTHER||% Ratio of LS Means|91.0||||0.0028|TWO_SIDED|95.0|85.7|96.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.67|85.70|0.0028
71915167|NCT01804842|143351413|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.9||||0.0024|TWO_SIDED|95.0|85.58|96.53|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||96.53|85.58|0.0024
71683237|NCT01492101|142884687|EQUIVALENCE|\[23\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|-4.5||||0.2575|TWO_SIDED|95.0|-12.2|3.28|||F-test|||||3.28|-12.2|0.2575
71683238|NCT01492101|142884687|EQUIVALENCE|\[24\] - Analysis of variance with change from baseline in linear transformed score at the last visit as the dependent variable and treatment arm, geographic region, prior use of eribulin, and receptor status as fixed effects.|Mean Difference (Final Values)|5.6||||0.1072|TWO_SIDED|95.0|-1.22|12.34|||F-test|||||12.34|-1.22|0.1072
71872747|NCT00561951|143263181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.002||95.0|-0.63|-0.14|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.14|-0.63|0.002
71872748|NCT00561951|143263181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.03||95.0|-0.52|-0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||-0.03|-0.52|0.030
71872749|NCT00561951|143263183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.624||95.0|-0.18|0.11|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.11|-0.18|0.624
71872750|NCT00561951|143263183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.129||95.0|-0.26|0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).||0.03|-0.26|0.129
71872751|NCT04508023|143263220|SUPERIORITY||Cox Proportional Hazard|1.16||||0.626|TWO_SIDED|95.0|0.63|2.15|||Log Rank|Log rank test stratified by the time from COVID-19 positive test to randomization.||||2.15|0.63|0.626
71872752|NCT03261700|143263279|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on Empowerment via the Personal Progress Scale Revised||||<.05
71872753|NCT03261700|143263280|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Comparison of groups on self-efficacy via the General Self-Efficacy Scale||||<.05
71872754|NCT01340196|143263300|SUPERIORITY_OR_OTHER||Geometric mean ratio|121.89|STANDARD_DEVIATION|14.1|||TWO_SIDED|90.0|111.714|132.999|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|||132.999|111.714|
71872755|NCT01340196|143263301|SUPERIORITY_OR_OTHER||Geometric mean ratio|94.72|STANDARD_DEVIATION|17.2|||TWO_SIDED|90.0|85.215|105.29|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||105.290|85.215|
71872756|NCT01340196|143263302|SUPERIORITY_OR_OTHER||Geometric mean ratio|147.12|STANDARD_DEVIATION|14.6||||90.0|134.482|160.943|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||160.943|134.482|
71872757|NCT01340196|143263303|SUPERIORITY_OR_OTHER||Geometric mean ratio|77.88|STANDARD_DEVIATION|13.4|||TWO_SIDED|90.0|71.24|85.15|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||85.15|71.24|
71872758|NCT01340196|143263304|SUPERIORITY_OR_OTHER||Geometric mean ratio|81.73|STANDARD_DEVIATION|20.1|||TWO_SIDED|90.0|71.56|93.34|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||93.34|71.56|
71872759|NCT01340196|143263305|SUPERIORITY_OR_OTHER||Geometric mean ratio|75.27|STANDARD_DEVIATION|13.7|||TWO_SIDED|90.0|68.71|82.45|||ANOVA|No formal testing. Investigation of relative bioavailability.|The standard deviation is actually the intra-individual gCV.|||82.45|68.71|
71872760|NCT04256603|143263319|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||wilcox two sample test||||0.67
71872761|NCT00676065|143263323|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||0.9|0.2|
71872762|NCT00676065|143263323|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||TWO_SIDED|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||0.9|0.2|
71872763|NCT00676065|143263324|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.8|1.7|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.7|0.8|
71872764|NCT00676065|143263324|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.0|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.0|0.5|
71872765|NCT00676065|143263325|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.4|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.||1.4|0.5|
71872766|NCT00676065|143263325|NON_INFERIORITY_OR_EQUIVALENCE|The LASS study was designed to analyse rare events (incidence rate \<1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.6|1.5|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.||1.5|0.6|
71915168|NCT01804842|143351413|SUPERIORITY_OR_OTHER||% Ratio of LS Means|95.1||||0.0992|TWO_SIDED|95.0|89.54|100.99|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||100.99|89.54|0.0992
71872767|NCT03401229|143263339|SUPERIORITY||Mean Difference (Net)|-0.57|||<|0.0001|TWO_SIDED|95.0|-0.852|-0.289||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.289|-0.852|<0.0001
71872768|NCT03401229|143263340|SUPERIORITY||Mean Difference (Net)|-0.27||||0.0048|TWO_SIDED|95.0|-0.458|-0.083||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate. Both of the co-primary endpoints were tested at 0.01 (two-sided).|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||The primary analysis compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in total NPS and/or the change from baseline in NBS are similar between benralizumab and placebo. H1: Both of the change from baseline in total NPS and the change from baseline in NBS are different between benralizumab and placebo.||-0.083|-0.458|0.0048
71872769|NCT03401229|143263341|SUPERIORITY||Mean Difference (Net)|-5.212||||0.0821|TWO_SIDED|95.0|-11.087|0.664||Since both primary endpoints were significant at significant level of 0.01 level, this endpoint was tested at significant level of 0.05.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||0.664|-11.087|0.0821
71915169|NCT01804842|143351414|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.4||||0.0006|TWO_SIDED|95.0|85.55|95.56|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.56|85.55|0.0006
71915170|NCT01804842|143351414|SUPERIORITY_OR_OTHER||% Ratio of LS Means|90.5||||0.0007|TWO_SIDED|95.0|85.65|95.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||95.67|85.65|0.0007
71915171|NCT01804842|143351414|SUPERIORITY_OR_OTHER||% Ratio of LS Means|94.3||||0.0389|TWO_SIDED|95.0|89.24|99.69|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment\*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.||99.69|89.24|0.0389
71683239|NCT00460265|142884696|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.873||||0.1403||95.0|0.729|1.046|||Log Rank|Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))|Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.|||1.046|0.729|0.1403
71872770|NCT03401229|143263342|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.066|TWO_SIDED|95.0|0.55|1.02||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal because test for change from baseline in SNOT-22 at week 40 was not statistically significant.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the rate of incidence of first NP surgery and/or SCS use for NP between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.02|0.55|0.0660
71872771|NCT03401229|143263343|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.5008|TWO_SIDED|95.0|0.53|1.36||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of first NP surgery between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.36|0.53|0.5008
71872772|NCT03401229|143263344|SUPERIORITY||Mean Difference (Net)|-0.218||||0.0029|TWO_SIDED|95.0|-0.361|-0.074||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.074|-0.361|0.0029
71915172|NCT04222673|143351444|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
71915173|NCT04222673|143351445|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
71915174|NCT04222673|143351446|OTHER|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71915175|NCT04222673|143351447|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71915176|NCT04222673|143351448|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71915177|NCT04222673|143351449|SUPERIORITY|Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||||0.05|||||||the Reliable Change Index|||||||.05
71683240|NCT00460265|142884697|SUPERIORITY_OR_OTHER||Difference in percentages|10.98||||||95.0|3.13|18.68||||||||18.68|3.13|
71683241|NCT00460265|142884697|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||||95.0|1.15|2.44||||||||2.44|1.15|
71683242|NCT00460265|142884701|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78||||||95.0|0.659|0.922|||||Cox proportional hazards model stratified by IVRS randomization factors|||0.922|0.659|
71872773|NCT03401229|143263345|SUPERIORITY||Mean Difference (Net)|-0.475||||0.0054|TWO_SIDED|95.0|-0.81|-0.141||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NPS is similar between benralizumab and placebo. H1: The change from baseline in NPS is different between benralizumab and placebo.||-0.141|-0.810|0.0054
71872774|NCT03401229|143263346|SUPERIORITY||Mean Difference (Net)|-0.287||||0.0032|TWO_SIDED|95.0|-0.477|-0.096||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in NBS is similar between benralizumab and placebo. H1: The change from baseline in NBS is different between benralizumab and placebo.||-0.096|-0.477|0.0032
71872775|NCT03401229|143263347|SUPERIORITY||Mean Difference (Net)|-7.492||||0.0188|TWO_SIDED|95.0|-13.741|-1.243||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline of benralizumab with placebo. H0: The change from baseline in SNOT-22 total score is similar between benralizumab and placebo. H1: The change from baseline in SNOT-22 total score is different between benralizumab and placebo.||-1.243|-13.741|0.0188
71872776|NCT03401229|143263348|SUPERIORITY||Mean Difference (Net)|-0.237||||0.0023|TWO_SIDED|95.0|-0.389|-0.084||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline DSS score of benralizumab with placebo. H0: The change from baseline in DSS score is similar between benralizumab and placebo. H1: The change from baseline in DSS score is different between benralizumab and placebo.||-0.084|-0.389|0.0023
71872777|NCT03401229|143263349|SUPERIORITY||Mean Difference (Net)|-0.856||||0.2375|TWO_SIDED|95.0|-2.281|0.57||Based on pre-specified testing strategy, this endpoint was not tested for statistical significance and the p-value was considered nominal.|ANCOVA|ANCOVA following WP (WP for NP surgery), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status.||This endpoint compared the changes from baseline LMS score of benralizumab with placebo. H0: The change from baseline in LMS score is similar between benralizumab and placebo. H1: The change from baseline in LMS score is different between benralizumab and placebo.||0.570|-2.281|0.2375
71872778|NCT03401229|143263350|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5419|TWO_SIDED|95.0|0.51|1.43||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.43|0.51|0.5419
71872779|NCT03401229|143263351|SUPERIORITY||Odds Ratio (OR)|0.69||||0.0913|TWO_SIDED|95.0|0.44|1.06||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||1.06|0.44|0.0913
71872780|NCT03401229|143263352|SUPERIORITY||Odds Ratio (OR)|0.65||||0.0362|TWO_SIDED|95.0|0.44|0.97||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Cochran-Mantel-Haenszel|The odds ratio estimate was obtained from the Cochran-Mantel-Haenszel test controlling for region (US/non-US) and baseline comorbid asthma status.||This endpoint compared the proportion of subjects with NP surgery or SCS\_NP between benralizumab and placebo. H0: The proportion is similar between benralizumab and placebo. H1: The proportion is different between benralizumab and placebo.||0.97|0.44|0.0362
71872781|NCT03401229|143263353|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.1505|TWO_SIDED|95.0|0.53|1.1||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Regression, Cox|A Cox proportional hazards model including covariates treatment group, region (US/Non-US) and baseline comorbid asthma status.||The endpoint compared the rate of incidence of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Hazard ratio (HR) is benralizumab vs placebo and HR less than 1 indicates longer time to event||1.10|0.53|0.1505
71872782|NCT03401229|143263357|SUPERIORITY||Rate Ratio|0.79||||0.2189|TWO_SIDED|95.0|0.54|1.15||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|Negative Bionomial Model|Model included treatment, US/non-US and prior use of SCS\_NP with total number of courses of SCS\_NP as outcome and log of follow-up time as an offset||The endpoint compared the rate of SCS\_NP use between benralizumab and placebo. H0: The rate is similar between benralizumab and placebo. H1: the rate is different between benralizumab and placebo. Rate ratio is benralizumab vs placebo and Rate ratio less than 1 indicates less likely of SCS\_NP use.||1.15|0.54|0.2189
71872783|NCT03401229|143263358|SUPERIORITY||Median Difference (Net)|-1.854||||0.0036|TWO_SIDED|95.0|-3.101|-0.608||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.608|-3.101|0.0036
71872784|NCT03401229|143263359|SUPERIORITY||Mean Difference (Net)|-0.166||||0.0941|TWO_SIDED|95.0|-0.36|0.028||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||0.028|-0.360|0.0941
71872785|NCT03401229|143263360|SUPERIORITY||Mean Difference (Net)|-0.213||||0.0246|TWO_SIDED|95.0|-0.399|-0.027||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||-0.027|-0.399|0.0246
71872786|NCT03401229|143263361|SUPERIORITY||Mean Difference (Net)|0.672||||0.5833|TWO_SIDED|95.0|-1.73|3.074||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||3.074|-1.730|0.5833
71872787|NCT03401229|143263362|SUPERIORITY||Median Difference (Net)|2.684||||0.0619|TWO_SIDED|95.0|-0.134|5.502||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|ANCOVA following hybrid WP/WOCF and MI (assuming MAR), adjusting for treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||5.502|-0.134|0.0619
71872788|NCT03401229|143263363|SUPERIORITY||Median Difference (Net)|-5.057||||0.102|TWO_SIDED|95.0|-11.129|1.015||This endpoint was not a part of the pre-specified testing strategy and was not tested for statistical significance. The p-value was considered nominal.|ANCOVA|Following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status||This endpoint compared the changes from baseline score between benralizumab and placebo. H0: The change from baseline score is similar between benralizumab and placebo. H1: The change from baseline score is different between benralizumab and placebo.||1.015|-11.129|0.1020
71872789|NCT01287065|143263396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.377|||||TWO_SIDED|90.0|0.293|0.462|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg PM minus Placebo|||0.462|0.293|
71872790|NCT01287065|143263396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.422|||||TWO_SIDED|90.0|0.337|0.507|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minus Placebo|||0.507|0.337|
71872791|NCT01287065|143263396|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.044|||||TWO_SIDED|90.0|-0.125|0.036|||Mixed Models Analysis||Mean difference =FF/VI 100/25 µg AM minusFF/VI 100/25 µg PM|||0.036|-0.125|
71872792|NCT02875977|143263400|SUPERIORITY||Odds Ratio (OR)|1.794||||0.17|TWO_SIDED|95.0|0.782|4.119|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling||4.119|0.782|0.17
71872793|NCT02875977|143263401|SUPERIORITY||Odds Ratio (OR)|0.564||||0.056|TWO_SIDED|95.0|0.314|1.014|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling||1.014|0.314|0.056
71872794|NCT02875977|143263402|SUPERIORITY||Odds Ratio (OR)|1.044||||0.9|TWO_SIDED|95.0|0.517|2.11|||Regression, Logistic|The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status||The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling||2.110|0.517|0.90
71872795|NCT02875977|143263403|SUPERIORITY||Z-Score|-1.4262||||0.16|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling||||0.16
71872796|NCT02875977|143263404|SUPERIORITY||Mean Difference (Final Values)|-4.456|STANDARD_ERROR_OF_MEAN|6.5481||0.5|TWO_SIDED|95.0|-17.6149|8.7028|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling||8.7028|-17.6149|0.50
71872797|NCT01259726|143263406|SUPERIORITY_OR_OTHER_LEGACY||||||<=|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<=0.0001
71872798|NCT01259726|143263406|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
71872799|NCT01259726|143263406|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||<0.0001
71872800|NCT01259726|143263407|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
71915178|NCT04222673|143351450|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71872801|NCT01259726|143263407|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.002
71872802|NCT01259726|143263407|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.088|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.088
71872803|NCT01259726|143263408|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.054|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.054
71872804|NCT01259726|143263408|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.008
71872805|NCT01259726|143263408|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.101|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.101
71872806|NCT01259726|143263409|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
71872807|NCT01259726|143263409|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.066|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.066
71872808|NCT01259726|143263409|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.045|TWO_SIDED|||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared|||||||=0.045
71872809|NCT02168842|143263447|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.79||||0.073|TWO_SIDED|95.0|0.61|1.03|||Log Rank|||||1.03|0.61|0.073
71872810|NCT02168842|143263448|EQUIVALENCE|Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.|Hazard Ratio (HR)|1.53||||0.21|TWO_SIDED|95.0|0.78|3.01|||Log Rank|||||3.01|0.78|0.21
71872811|NCT02168842|143263449|EQUIVALENCE|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.83||||0.35|TWO_SIDED|95.0|0.56|1.22|||Log Rank|||||1.22|0.56|0.35
71872812|NCT00325039|143263457|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success rate (RMUS-TMUS)|3.0|||||TWO_SIDED|95.0|-3.6|9.6||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||9.6|-3.6|
71872813|NCT00325039|143263458|SUPERIORITY_OR_OTHER||Difference in proportions|-4.1||||0.14||95.0||||This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.|Chi-squared|||Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.||||0.14
71872814|NCT00325039|143263459|NON_INFERIORITY_OR_EQUIVALENCE|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success (RMUS - TMUS)|6.4|||||TWO_SIDED|95.0|-1.6|14.3||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.||14.3|-1.6|
71872815|NCT00325039|143263460|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.||||0.47
71872816|NCT00325039|143263461|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||The UDI measure was compared using a two-sample t test.||||0.41
71872817|NCT00426153|143263465|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||Rank-sum test|||P values \<0.05 were considered statistically significant.||||0.048
71872818|NCT00426153|143263466|SUPERIORITY_OR_OTHER|||||||0.045||95.0||||P values \< 0.05 were considered statistically significant|Rank sum|||||||0.045
71872819|NCT00426153|143263467|SUPERIORITY_OR_OTHER|||||||0.98||95.0||||P Values \< 0.05 were considered statistically significant|Rank sum|||||||0.98
71872820|NCT00343252|143263482|SUPERIORITY_OR_OTHER|||||||0.642||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.||||0.642
71872821|NCT00343252|143263483|SUPERIORITY_OR_OTHER|||||||0.683||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.||||0.683
71872822|NCT00343252|143263484|SUPERIORITY_OR_OTHER|||||||0.809||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.||||0.809
71872823|NCT00343252|143263485|SUPERIORITY_OR_OTHER|||||||0.986||95.0||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.||||0.986
71872824|NCT00343252|143263486|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.746|TWO_SIDED|95.0|0.85|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 6-month endpoint.||1.26|0.85|0.746
71872825|NCT00343252|143263487|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.719|TWO_SIDED|95.0|0.86|1.25||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in worst back pain at the 12-month endpoint.||1.25|0.86|0.719
71872826|NCT00343252|143263488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.681|TWO_SIDED|95.0|0.86|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction for average back pain at the 6-month endpoint.||1.26|0.86|0.681
71872827|NCT00343252|143263489|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.789|TWO_SIDED|95.0|0.86|1.23||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a \>=30% reduction in average back pain at the 12-month endpoint.||1.23|0.86|0.789
71872828|NCT00343252|143263490|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.||||0.968
71872829|NCT00343252|143263491|SUPERIORITY_OR_OTHER|||||||0.568||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.||||0.568
71872830|NCT00343252|143263492|SUPERIORITY_OR_OTHER|||||||0.932||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.||||0.932
71872831|NCT00343252|143263493|SUPERIORITY_OR_OTHER|||||||0.814||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.||||0.814
71872832|NCT00343252|143263494|SUPERIORITY_OR_OTHER|||||||0.572||95.0||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.||||0.572
71915179|NCT04222673|143351451|SUPERIORITY|||||||0.05|||||||the Reliable Change Index|||Given the small sample size and recommendations for pilot studies, quantitative analyses were descriptive (frequencies, means) and based on the Reliable Change Index (RCI) for each participant for each outcome measure. The RCI is used to determine whether pre- to post- score differences are statistically reliable and to categorize changes as either improved, deteriorated, or indeterminate. A statistical threshold of RCI score z = + 1.96 and p \< .05 was used to establish clinical significance.||||.05
71915180|NCT02352090|143351456|OTHER|||||||0.27|||||||ANOVA|||||||0.27
71915181|NCT04323098|143351467|SUPERIORITY|||||||0.0057||||||P-value was based on two-sided t-test against 0.|t-test, 2 sided|||||||0.0057
71872833|NCT00343252|143263497|SUPERIORITY_OR_OTHER|||||||0.6||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.600
71872834|NCT00343252|143263498|SUPERIORITY_OR_OTHER|||||||0.399||95.0||||P-value is for responder versus non-responder.|Chi-squared|||||||0.399
71915182|NCT00068822|143351475|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.49|TWO_SIDED|95.0|-1.3|2.8|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||2.8|-1.3|0.49
71872835|NCT00343252|143263499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.453|TWO_SIDED|95.0|0.89|1.28|||Log Rank|||||1.28|0.89|0.453
71872836|NCT00343252|143263500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.353|TWO_SIDED|95.0|0.91|1.3|||Log Rank|||||1.30|0.91|0.353
71872837|NCT00343252|143263501|SUPERIORITY_OR_OTHER|||||||0.943||95.0|||||ANCOVA|||||||0.943
71872838|NCT00343252|143263502|SUPERIORITY_OR_OTHER|||||||0.553||95.0|||||ANCOVA|||||||0.553
71683243|NCT01075399|142884735|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.883|||<|0.001|TWO_SIDED|90.0|0.802|0.929||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV max:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV max of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.929|0.802|<0.001
71872839|NCT00307125|143263599|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||Analysis by Fisher's exact test counting participants with 50% decrease in anti-HLA antibodies at any time within 12 months post treatment initiation||||>0.999
71872840|NCT00307125|143263604|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
71872841|NCT00307125|143263605|SUPERIORITY_OR_OTHER||||||>|0.999|TWO_SIDED||||||Fisher Exact|||||||>0.999
71683244|NCT01075399|142884735|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.887|||<|0.001|TWO_SIDED|90.0|0.792|0.925||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV mean:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing SUV mean of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."||0.925|0.792|<0.001
71872842|NCT00051363|143263607|SUPERIORITY_OR_OTHER|||||||0.0074||||||"2M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).~After correction for multiple comparisons (sequential Bonferroni) P Value=0.0444 (NS)"|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M E/F Function- SWMT-OMD.||||0.0074
71872843|NCT00051363|143263607|SUPERIORITY_OR_OTHER|||||||0.2254||||||6M E/F Function- SWMT-OMD; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M E/F Function- SWMT-OMD.||||0.2254
71872844|NCT00051363|143263608|SUPERIORITY_OR_OTHER|||||||0.4538||||||DX A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for DX A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.4538
71872845|NCT00051363|143263608|SUPERIORITY_OR_OTHER|||||||0.086||||||2M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.0860
71915183|NCT00068822|143351476|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.45|TWO_SIDED|95.0|-1.7|3.7|||ANCOVA|||SF-36 Physical Component Summary treatment effect||3.7|-1.7|0.45
71915184|NCT00068822|143351476|SUPERIORITY_OR_OTHER||Treatment Effect|1.0||||0.83|TWO_SIDED|95.0|-3.7|4.6|||ANCOVA|||SF-36 Mental Component Summary treatment effect||4.6|-3.7|0.83
71915185|NCT00068822|143351476|SUPERIORITY_OR_OTHER||Treatment Effect|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Frequency Index treatment effect||0.6|-0.2|0.33
71915186|NCT00068822|143351476|SUPERIORITY_OR_OTHER||Treatment Effect|0.33||||0.33|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain Bothersome Index treatment effect||0.6|-0.2|0.33
71915187|NCT00068822|143351476|SUPERIORITY_OR_OTHER||Treatment Effect|0.05||||0.13|TWO_SIDED|95.0|-0.01|0.11|||ANCOVA|||EQ-5D Index treatment effect||0.11|-0.01|0.13
71915188|NCT00068822|143351476|SUPERIORITY_OR_OTHER||Treatment Effect|0.4||||0.5|TWO_SIDED|95.0|-0.8|1.6|||ANCOVA|||SOF-ADL treatment effect||1.6|-0.8|0.5
71683245|NCT01075399|142884735|SUPERIORITY_OR_OTHER||Pearson's Correlation Coefficient|0.945|||<|0.001|TWO_SIDED|90.0|0.904|0.967||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor to background SUV ratio:~The reproducibility of \[F-18\]HX4 uptake in primary tumors was assessed by comparing tumor to background SUV ratio (T/B) of the 1st and 2nd \[F18\]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in T/B values, and for establishing reproducibility within ±20% or ±25%."||0.967|0.904|<0.001
71683246|NCT00424021|142884739|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.5|STANDARD_DEVIATION|46.93|||TWO_SIDED|95.0|-8.3|17.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||17.3|-8.3|
71872846|NCT00051363|143263608|SUPERIORITY_OR_OTHER|||||||0.2103||||||6M A/P Function- PFN-TOTL; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."||||0.2103
71872847|NCT00051363|143263609|SUPERIORITY_OR_OTHER|||||||0.7936||||||DX L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for DX L/M Function- BSRT-SR.||||0.7936
71872848|NCT00051363|143263609|SUPERIORITY_OR_OTHER|||||||0.5444||||||2M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR.||||0.5444
71872849|NCT00051363|143263609|SUPERIORITY_OR_OTHER|||||||0.7569||||||6M L/M Function- BSRT-SR; P\<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR.||||0.7569
71872850|NCT00051363|143263610|SUPERIORITY_OR_OTHER|||||||0.5606||||||"2M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5606
71872851|NCT00051363|143263610|SUPERIORITY_OR_OTHER|||||||0.6487||||||"2M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.6487
71872852|NCT00051363|143263610|SUPERIORITY_OR_OTHER|||||||0.5667||||||"2M L/M Function- PN-RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.5667
71872853|NCT00051363|143263610|SUPERIORITY_OR_OTHER|||||||0.3972||||||"6M L/M Function- PN-RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3972
71872854|NCT00051363|143263610|SUPERIORITY_OR_OTHER|||||||0.3973||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3973
71872855|NCT00051363|143263610|SUPERIORITY_OR_OTHER|||||||0.3055||||||"6M L/M Function- PN-RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."||||0.3055
71915189|NCT00068822|143351477|SUPERIORITY_OR_OTHER||Adjusted treatment effect|0.7||||0.19|TWO_SIDED|95.0|-0.3|1.7|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.||1.7|-0.3|0.19
71915190|NCT03146403|143351478|SUPERIORITY|||||||0.7474|||||||Wilcoxon (Mann-Whitney)|||||||0.7474
71915191|NCT03146403|143351479|SUPERIORITY|||||||0.645|||||||Wilcoxon (Mann-Whitney)|||||||0.6450
71915192|NCT03146403|143351480|SUPERIORITY|||||||0.3157|||||||Chi-squared|||||||0.3157
71915193|NCT03146403|143351481|SUPERIORITY|||||||0.3869|||||||Log Rank|||||||0.3869
71915194|NCT03146403|143351482|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.2200
71915195|NCT00926185|143351497|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.06||||0.9381|TWO_SIDED|95.0|-0.26|0.39|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.39|-0.26|0.9381
71915196|NCT00926185|143351497|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.2||||0.3585|TWO_SIDED|95.0|-0.13|0.53|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.53|-0.13|0.3585
71915197|NCT00926185|143351497|SUPERIORITY_OR_OTHER_LEGACY||Treatment Effect|0.27||||0.1375|TWO_SIDED|95.0|-0.06|0.6|||Dunnett's test||Analysis of covariance model with treatment, baseline, and site.|||0.60|-0.06|0.1375
71872856|NCT00051363|143263611|SUPERIORITY_OR_OTHER|||||||0.3699||||||"2M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3699
71872857|NCT00051363|143263611|SUPERIORITY_OR_OTHER|||||||0.9673||||||"2M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9673
71872858|NCT00051363|143263611|SUPERIORITY_OR_OTHER|||||||0.3426||||||"2M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3426
71872859|NCT00051363|143263611|SUPERIORITY_OR_OTHER|||||||0.3901||||||"6M A/P Function- PVT-MedRT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3901
71872860|NCT00051363|143263611|SUPERIORITY_OR_OTHER|||||||0.9464||||||"6M A/P Function- PVT-MedRT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9464
71872861|NCT00051363|143263611|SUPERIORITY_OR_OTHER|||||||0.4372||||||"6M A/P Function- PVT-MedRT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.4372
71915198|NCT03949621|143351499|OTHER|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9632|||||TWO_SIDED|90.0|0.7938|1.1688||||||||1.1688|0.7938|
71915199|NCT03949621|143351500|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9606|||||TWO_SIDED|90.0|0.798|1.1562||||||||1.1562|0.798|
71915200|NCT03949621|143351501|OTHER|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0162|||||TWO_SIDED|90.0|0.9001|1.1473||||||||1.1473|0.9001|
71915201|NCT01236768|143351504|EQUIVALENCE|Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.||||||0.089|||||||Chi-squared|||Comparative evaluation of AG200-15 and Levora||||0.089
71915202|NCT02069704|143351508|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|99.4|||||TWO_SIDED|90.0|90.5|109.0|||||For the ratio: BEVZ92 represents the numerator and reference bevacizumab the denominator|Based on previously published PK data for reference bevacizumab in metastatic colorectal cancer, we assumed a conservative inter-participant coefficient of variation for AUC of around 35%. A sample size of 51 patients in each treatment arm could show bioequivalence with a nominal power of 90% and an α of 0·05, if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0-336h and AUCss were within the acceptance interval of 80%-125%.||109.0|90.5|
71915203|NCT02069704|143351509|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio BEVZ92 to Avastin|100.0|||||TWO_SIDED|90.0|90.2|112.0||||||||112.0|90.2|
71683247|NCT00424021|142884740|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.3|STANDARD_DEVIATION|73.16|||TWO_SIDED|95.0|-30.3|9.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||9.7|-30.3|
71872862|NCT00051363|143263612|SUPERIORITY_OR_OTHER|||||||0.9656||||||"2M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9656
71915204|NCT00638690|143351521|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||<|0.0001|TWO_SIDED|95.0|0.543|0.768||Nominal P-value is 0.0142 at interim analysis based on group sequential design.|Log Rank|This was a stratified analysis.||||0.768|0.543|<0.0001
71915205|NCT00638690|143351522|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.462|0.728||Nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.728|0.462|<0.0001
71683248|NCT00424021|142884741|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|STANDARD_DEVIATION|83.08|||TWO_SIDED|95.0|-27.4|18.0||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||18.0|-27.4|
71683249|NCT00424021|142884742|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.9|STANDARD_DEVIATION|77.04|||TWO_SIDED|95.0|-34.9|7.1||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||7.1|-34.9|
71683250|NCT00424021|142884744|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_DEVIATION|1.323|||TWO_SIDED|95.0|-0.15|0.57||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.57|-0.15|
71915206|NCT00638690|143351523|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.266|||<|0.001|TWO_SIDED|95.0|3.459|8.018||Nominal P-value = 0.05.|Chi-squared|||||8.018|3.459|<0.001
71915207|NCT00638690|143351524|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.673|||<|0.0001|TWO_SIDED|95.0|0.585|0.776||The nominal P-value = 0.05.|Log Rank|This was a stratified analysis.||||0.776|0.585|<0.0001
71915208|NCT00605358|143351525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.018|TWO_SIDED|95.0|1.17|4.93|||Chi-squared|||Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.||4.93|1.17|.018
71915209|NCT02861118|143351526|OTHER|||||||0.024|||||||Regression, Logistic|||IBD||||0.024
71915210|NCT02861118|143351526|OTHER|||||||0.006|||||||Regression, Logistic|||Corticosteroids||||0.006
71915211|NCT02861118|143351526|OTHER|||||||0.006|||||||Regression, Logistic|||Chronic Obstructive Pulmonary Disease||||0.006
71915212|NCT02861118|143351527|OTHER|||||||0.044|||||||Regression, Logistic|||IBD||||0.044
71915213|NCT02861118|143351527|OTHER|||||||0.003|||||||Regression, Logistic|||Corticosteroids||||0.003
71915214|NCT02861118|143351527|OTHER|||||||0.003|||||||Regression, Logistic|||Myocardial Infarction||||0.003
71915215|NCT02861118|143351528|OTHER|||||||0.007|||||||Regression, Logistic|||Corticosteroids||||0.007
71915216|NCT02861118|143351529|OTHER|||||||0.002|||||||Regression, Logistic|||Corticosteroids||||0.002
71915217|NCT02861118|143351529|OTHER|||||||0.003|||||||Regression, Logistic|||Skin Disease||||0.003
71915218|NCT02623699|143351584|SUPERIORITY||least square (LS) mean difference|1.2|STANDARD_ERROR_OF_MEAN|2.22|=|0.9689|TWO_SIDED|95.0|-3.19|5.53||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank||ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the Analysis of covariance (ANCOVA) for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||5.53|-3.19|= 0.9689
71915219|NCT02623699|143351585|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|< 0.0001
71915220|NCT02623699|143351585|SUPERIORITY||Difference in LS geometric mean ratio|0.75|||=|0.0002|TWO_SIDED|95.0|0.6|0.95|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.95|0.60|=0.0002
71915221|NCT02623699|143351585|SUPERIORITY||Difference in LS geometric mean ratio|0.81|||=|0.0641|TWO_SIDED|95.0|0.65|1.02|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||1.02|0.65|=0.0641
71915222|NCT02623699|143351585|SUPERIORITY||Difference in LS geometric mean ratio|0.67|||<|0.0001|TWO_SIDED|95.0|0.53|0.84|||Wilcoxon rank sum test|||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.84|0.53|<0.0001
71915223|NCT02623699|143351586|SUPERIORITY||Difference in LS geometric mean ratio|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78||The analysis was based on ANCOVA model with natural log transformed data. P-value for this secondary outcome measure (OM) is nominal as statistical significance was not met on the primary OM.|ANCOVA|||The ANCOVA model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone. Multiple imputation was used to handle missing data for withdrawals. Difference in LS geometric mean ratio to baseline (BIIB067:Placebo) was calculated.||0.78|0.49|< 0.0001
71872863|NCT00051363|143263612|SUPERIORITY_OR_OTHER|||||||0.6765||||||"2M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.6765
71872864|NCT00051363|143263612|SUPERIORITY_OR_OTHER|||||||0.5288||||||"2M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.5288
71872865|NCT00051363|143263612|SUPERIORITY_OR_OTHER|||||||0.7807||||||"6M A/P Function- PVT-Slo10%RT (Mild OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.7807
71872866|NCT00051363|143263612|SUPERIORITY_OR_OTHER|||||||0.9603||||||"6M A/P Function- PVT-Slo10%RT (Moderate OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.9603
71872867|NCT00051363|143263612|SUPERIORITY_OR_OTHER|||||||0.3075||||||"6M A/P Function- PVT-Slo10%RT (Severe OSA); P\<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."||||0.3075
71872868|NCT00051363|143263613|SUPERIORITY_OR_OTHER|||||||0.4262||||||2M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.4262
71872869|NCT00051363|143263613|SUPERIORITY_OR_OTHER|||||||0.3161||||||2M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.3161
71872870|NCT00051363|143263613|SUPERIORITY_OR_OTHER|||||||0.1835||||||2M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.1835
71915224|NCT02623699|143351587|SUPERIORITY||Difference in LS geometric mean ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.25|0.45||The analysis was based on ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, baseline disease duration since symptom onset, and use of riluzole or edaravone.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||Difference in LS geometric mean ratio (BIIB067:Placebo) was calculated.||0.45|0.25|< 0.0001
71683251|NCT00424021|142884745|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.659|||TWO_SIDED|95.0|0.01|0.92||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.92|0.01|
71915225|NCT02623699|143351588|SUPERIORITY||LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|5.829|=|0.3233|TWO_SIDED|95.0|-3.528|19.322||Joint rank p-value was calculated from ANCOVA model which included treatment as fixed effect, adjusts for covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.|ANCOVA model included treatment as a fixed effect, adjusts for the covariates: Baseline disease duration since symptom onset, baseline ALSFRS-R total score, baseline SVC, and use of riluzole or edaravone.|Joint rank test combining function and mortality were used for statistical inference and the estimates were from the ANCOVA for change from baseline. Multiple imputation was used to handle missing data for withdrawals other than death in the joint rank analysis. Multiple imputation was used to handle all missing data in the ANCOVA for change from baseline.||19.322|-3.528|= 0.3233
71915226|NCT02623699|143351589|SUPERIORITY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.118|=|0.839|TWO_SIDED|95.0|-0.207|0.255||ANCOVA model included treatment as fixed effect and adjusts for following covariates: Baseline disease duration since symptom onset, baseline HHD overall megascore, and use of riluzole/edaravone. Missing data were handled using multiple imputation.|ANCOVA|P-value for this secondary OM is nominal as statistical significance was not met on the primary OM.||||0.255|-0.207|= 0.8390
71915227|NCT01627782|143351613|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.0|||<|0.001|TWO_SIDED|70.0|-20.0|-12.01|||Mixed Effect Model Repeated Measure|||||-12.01|-20.00|< 0.001
71915228|NCT01627782|143351613|SUPERIORITY_OR_OTHER_LEGACY||Difference of Least Square Means|-16.4|||<|0.001|TWO_SIDED|70.0|-18.96|-13.84|||Mixed Effect Model Repeated Measure|||||-13.84|-18.96|< 0.001
71915229|NCT00089999|143351690|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.691|TWO_SIDED|95.0|0.3|1.9|||Fisher Exact|||||1.9|0.3|0.691
71915230|NCT00089999|143351691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.443|TWO_SIDED|95.0|0.3|1.6|||Fisher Exact||Overall Response (i.e. sum of Complete and Partial Responses) comparison|||1.6|0.3|0.443
71915231|NCT00616772|143351698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006||||0.22|TWO_SIDED|95.0|-0.016|0.004|||Repeated measures linear mixed model|Fixed effects for baseline cIMT, baseline atorvastatin dose, central imaging site, treatment group, time; interaction between treatment group and time||||0.004|-0.016|0.220
71915232|NCT00616772|143351699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002||||0.813|TWO_SIDED|95.0|-0.014|0.011|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline cIMT as covariate.||||0.011|-0.014|0.813
71915233|NCT00616772|143351700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007||||0.249|TWO_SIDED|95.0|-0.018|0.005|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.005|-0.018|0.249
71915234|NCT00616772|143351701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005||||0.487|TWO_SIDED|95.0|-0.02|0.01|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.010|-0.020|0.487
71915235|NCT00616772|143351702|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.016||||0.112|TWO_SIDED|95.0|-0.004|0.035|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate||||0.035|-0.004|0.112
71915236|NCT04315298|143351730|SUPERIORITY||LS Mean (log scale)|-1.25|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.456|-1.035||P-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.035|-1.456|<0.0001
71915237|NCT04315298|143351730|SUPERIORITY||LS Mean (log scale)|-1.3|STANDARD_ERROR_OF_MEAN|0.107|<|0.0001|TWO_SIDED|95.0|-1.511|-1.09||p-value is based on the ANCOVA model for differences between treatment groups in terms of \[ln(CRP at day 4 ) - ln(baseline CRP)\].|ANCOVA|||||-1.090|-1.511|<0.0001
71915238|NCT04315298|143351731|SUPERIORITY||Risk Difference (RD)|7.1||||0.3707|TWO_SIDED|95.0|-8.4|21.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.7|-8.4|0.3707
71915239|NCT04315298|143351731|SUPERIORITY||Risk Difference (RD)|7.5||||0.3261|TWO_SIDED|95.0|-7.4|21.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||21.3|-7.4|0.3261
71915240|NCT04315298|143351732|SUPERIORITY||Risk Difference (RD)|6.2||||0.7328|TWO_SIDED|95.0|-26.2|36.8|||Cochran-Mantel-Haenszel|P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline||||36.8|-26.2|0.7328
71872871|NCT00051363|143263613|SUPERIORITY_OR_OTHER|||||||0.2462||||||6M L/M Function- BSRTDR-TotRec (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2462
71683252|NCT00424021|142884746|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.888|||TWO_SIDED|95.0|-0.02|1.02||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.02|-0.02|
71683253|NCT00424021|142884747|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_DEVIATION|1.721|||TWO_SIDED|95.0|-0.01|0.93||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||0.93|-0.01|
71683254|NCT00424021|142884754|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|19.41|||TWO_SIDED|95.0|-5.9|4.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.7|-5.9|
71872872|NCT00051363|143263613|SUPERIORITY_OR_OTHER|||||||0.2069||||||6M L/M Function- BSRTDR-TotRec (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.2069
71872873|NCT00051363|143263613|SUPERIORITY_OR_OTHER|||||||0.5235||||||6M L/M Function- BSRTDR-TotRec (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."||||0.5235
71872874|NCT00051363|143263614|SUPERIORITY_OR_OTHER|||||||0.5419||||||2M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5419
71872875|NCT00051363|143263614|SUPERIORITY_OR_OTHER|||||||0.89||||||2M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8900
71872876|NCT00051363|143263614|SUPERIORITY_OR_OTHER|||||||0.0031||||||2M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0031
71872877|NCT00051363|143263614|SUPERIORITY_OR_OTHER|||||||0.8703||||||6M E/F Function- SWMT-BehMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8703
71915241|NCT04315298|143351733|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5687|TWO_SIDED|95.0|0.76|1.66||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.66|0.76|0.5687
71683255|NCT00424021|142884755|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.4|STANDARD_DEVIATION|25.79|||TWO_SIDED|95.0|-14.4|-0.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||-0.3|-14.4|
71683256|NCT00424021|142884756|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.1|STANDARD_DEVIATION|25.31|||TWO_SIDED|95.0|-12.0|1.8||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||1.8|-12.0|
71683257|NCT00424021|142884757|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_DEVIATION|23.69|||TWO_SIDED|95.0|-8.4|4.6||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.||4.6|-8.4|
71683258|NCT03000530|142884814|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The Mixed Effect Model for Repeated Measures (MMRM) included the change from baseline in HAM-D total score at each visit as the dependent variables.||||-3.9|-10.2|< 0.0001
71683259|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.99||0.0223|TWO_SIDED|95.0|-4.3|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 2||-0.3|-4.3|0.0223
71872878|NCT00051363|143263614|SUPERIORITY_OR_OTHER|||||||0.1838||||||6M E/F Function- SWMT-BehMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.1838
71872879|NCT00051363|143263614|SUPERIORITY_OR_OTHER|||||||0.0739||||||6M E/F Function- SWMT-BehMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0739
71872880|NCT00051363|143263615|SUPERIORITY_OR_OTHER|||||||0.045||||||2M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.0450
71872881|NCT00051363|143263615|SUPERIORITY_OR_OTHER|||||||0.4512||||||2M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4512
71872882|NCT00051363|143263615|SUPERIORITY_OR_OTHER|||||||0.6672||||||2M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.6672
71872883|NCT00051363|143263615|SUPERIORITY_OR_OTHER|||||||0.8197||||||6M E/F Function- SWMT-ActMD (Mild OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8197
71872884|NCT00051363|143263615|SUPERIORITY_OR_OTHER|||||||0.989||||||6M E/F Function- SWMT-ActMD (Moderate OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9890
71872885|NCT00051363|143263615|SUPERIORITY_OR_OTHER|||||||0.5029||||||6M E/F Function- SWMT-ActMD (Severe OSA); P\<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.5029
71872886|NCT00051363|143263616|SUPERIORITY_OR_OTHER|||||||0.9518||||||2M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.9518
71872887|NCT00051363|143263616|SUPERIORITY_OR_OTHER|||||||0.4108||||||2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4108
71915242|NCT04315298|143351733|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7014|TWO_SIDED|95.0|0.74|1.62||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.62|0.74|0.7014
71915243|NCT04315298|143351734|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3622|TWO_SIDED|95.0|0.83|1.7||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.70|0.83|0.3622
71683260|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.18||0.001|TWO_SIDED|95.0|-6.4|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 3||-1.7|-6.4|0.0010
71872888|NCT00051363|143263616|SUPERIORITY_OR_OTHER|||||||0.4528||||||2M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.4528
71872889|NCT00051363|143263616|SUPERIORITY_OR_OTHER|||||||0.8391||||||6M E/F Function- SAT-D-NumRuCh (Mild OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8391
71872890|NCT00051363|143263616|SUPERIORITY_OR_OTHER|||||||0.2771||||||6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.2771
71872891|NCT00051363|143263616|SUPERIORITY_OR_OTHER|||||||0.8961||||||6M E/F Function- SAT-D-NumRuCh (Severe OSA); P\<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (\<=2 vs. \>=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation \< 85% (PSG), age \< 60 years, WASI Verbal IQ, and WASI Performance IQ."||||0.8961
71872892|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.654||||||DX- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.6540
71872893|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.9778||||||DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.9778
71872894|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.8314||||||DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.8314
71872895|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.5018||||||DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.||||0.5018
71872896|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.0052||||||2M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0052
71872897|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.2476||||||2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.2476
71872898|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.752||||||2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.7520
71915244|NCT04315298|143351734|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.5802|TWO_SIDED|95.0|0.79|1.63||P-value based on log-rank test stratified by disease severity (severe, critical) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.63|0.79|0.5802
71915245|NCT04315298|143351735|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.234|TWO_SIDED|95.0|0.83|2.02||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.83|0.2340
71683261|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|1.27||0.0233|TWO_SIDED|95.0|-5.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 4||-0.4|-5.5|0.0233
71872899|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.0002||||||2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
71872900|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.0022||||||6M- MWT-MSL; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0022
71872901|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.763||||||6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.7630
71872902|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.517||||||6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.5170
71872903|NCT00051363|143263617|SUPERIORITY_OR_OTHER|||||||0.0002||||||6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.||||0.0002
71872904|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.9291||||||DX- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9291
71872905|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.6152||||||DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.6152
71872906|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.704||||||DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.7040
71872907|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.9537||||||DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.||||0.9537
71872908|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.0004||||||2M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0004
71915246|NCT04315298|143351735|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.6949|TWO_SIDED|95.0|0.74|1.79||P-value based on log-rank test stratified by disease severity (severe, critical and MSOD) and use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.79|0.74|0.6949
71915247|NCT04315298|143351736|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.3151|TWO_SIDED|95.0|0.66|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||2.43|0.66|0.3151
71915248|NCT04315298|143351736|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.1884|TWO_SIDED|95.0|0.39|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.41|0.39|0.1884
71872909|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.3886||||||2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.3886
71872910|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.0236||||||2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0236
71872911|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.0005||||||2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
71872912|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.0005||||||6M- ESS-TS; Comparison of means by visit only; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0005
71872913|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.3796||||||6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.3796
71683262|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.37||0.0066|TWO_SIDED|95.0|-6.6|-1.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 5||-1.1|-6.6|0.0066
71683263|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.4||0.0019|TWO_SIDED|95.0|-7.3|-1.7|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 6||-1.7|-7.3|0.0019
71683264|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-4.5|STANDARD_ERROR_OF_MEAN|1.53||0.0043|TWO_SIDED|95.0|-7.6|-1.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 7||-1.5|-7.6|0.0043
71915249|NCT04315298|143351736|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.4356|TWO_SIDED|95.0|0.76|3.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||3.40|0.76|0.4356
71915250|NCT04315298|143351736|SUPERIORITY||Hazard Ratio (HR)|2.1||||0.0371|TWO_SIDED|95.0|1.01|4.4||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||4.40|1.01|0.0371
71915251|NCT04315298|143351736|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8923|TWO_SIDED|95.0|0.32|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||3.05|0.32|0.8923
71915252|NCT04315298|143351736|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.694|TWO_SIDED|95.0|0.25|2.71||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.71|0.25|0.6940
71915253|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|2.14||||0.0832|TWO_SIDED|95.0|0.81|5.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||5.65|0.81|0.0832
71915254|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|1.93||||0.1369|TWO_SIDED|95.0|0.77|4.8||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 87.04 pg/mL (median)||4.80|0.77|0.1369
71915255|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.9636|TWO_SIDED|95.0|0.28|1.95||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||1.95|0.28|0.9636
71915256|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|0.24||||0.0038|TWO_SIDED|95.0|0.08|0.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 87.04 pg/mL (median)||0.74|0.08|0.0038
71915257|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.738|TWO_SIDED|95.0|0.47|3.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 166.68pg/mL (Median)||3.13|0.47|0.7380
71915258|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7342|TWO_SIDED|95.0|0.48|3.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \<166.68pg/mL (Median)||3.05|0.48|0.7342
71915259|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|3.58||||0.1934|TWO_SIDED|95.0|0.79|16.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||16.17|0.79|0.1934
71915260|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|5.33||||0.0159|TWO_SIDED|95.0|1.19|23.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 166.68pg/mL (Median)||23.94|1.19|0.0159
71915261|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.6281|TWO_SIDED|95.0|0.13|8.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||8.75|0.13|0.6281
71915262|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.4971|TWO_SIDED|95.0|0.06|6.13||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \<254.95 pg/mL (Median)||6.13|0.06|0.4971
71915263|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|0.3||||0.299|TWO_SIDED|95.0|0.03|2.86||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||2.86|0.03|0.2990
71915264|NCT04315298|143351737|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.936|TWO_SIDED|95.0|0.22|4.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (Median)||4.41|0.22|0.9360
71915265|NCT04315298|143351738|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.9032|TWO_SIDED|95.0|0.52|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.47|0.52|0.9032
71915266|NCT04315298|143351738|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.0052|TWO_SIDED|95.0|0.29|0.88||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.88|0.29|0.0052
71915267|NCT04315298|143351738|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.1168|TWO_SIDED|95.0|0.48|1.21||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.21|0.48|0.1168
71915268|NCT04315298|143351738|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.3753|TWO_SIDED|95.0|0.69|1.72||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.72|0.69|0.3753
71915269|NCT04315298|143351738|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4956|TWO_SIDED|95.0|0.4|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.66|0.40|0.4956
71915270|NCT04315298|143351738|SUPERIORITY||Cox Proportional Hazard|1.01||||0.8439|TWO_SIDED|95.0|0.5|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.02|0.50|0.8439
71683265|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0318|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 8||-0.3|-6.4|0.0318
71683266|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.6|<|0.0001|TWO_SIDED|95.0|-10.2|-3.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 15||-3.9|-10.2|< 0.0001
71872914|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.0106||||||6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0106
71872915|NCT00051363|143263618|SUPERIORITY_OR_OTHER|||||||0.001||||||6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P\<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.||||0.0010
71872916|NCT01323634|143263659|SUPERIORITY_OR_OTHER||Least square mean difference|0.08|||<|0.001|TWO_SIDED|95.0|0.037|0.124|||ANCOVA|||||0.124|0.037|<0.001
71872917|NCT02678247|143263664|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|<|0.001|TWO_SIDED|95.0|0.8|2.3||alpha = 0.05|t-test, 2 sided|paired t-test||||2.3|0.8|<0.001
71872918|NCT02678247|143263665|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.1||0.664|TWO_SIDED|95.0|-0.06|0.04||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.04|-0.06|0.664
71872919|NCT02678247|143263666|SUPERIORITY||Mean Difference (Final Values)|-1.7|STANDARD_DEVIATION|3.05||0.026|TWO_SIDED|95.0|-3.17|-0.23||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||-0.23|-3.17|0.026
71872920|NCT02678247|143263667|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|4.58||0.847|TWO_SIDED|95.0|-2.0|2.42||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||2.42|-2|0.847
71872921|NCT02678247|143263668|SUPERIORITY||Mean Difference (Final Values)|-1.04|STANDARD_DEVIATION|2.87|<|0.017|TWO_SIDED|95.0|-2.42|0.34||p-value was adjusted using a Bonferonni correction with alpha set at 0.017|t-test, 2 sided|paired t-test||||0.34|-2.42|<0.017
71872922|NCT02678247|143263669|OTHER||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.58||0.7|TWO_SIDED|95.0|-0.53|0.77||p-value was adjusted using a Bonferonni correction with alpha set at 0.025|t-test, 2 sided|paired t-test||||0.77|-0.53|0.7
71872923|NCT02678247|143263670|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_DEVIATION|8.9||0.2|TWO_SIDED|95.0|-1.6|7.0||alpha = 0.05|t-test, 2 sided|paired t-test||||7.0|-1.6|0.20
71872924|NCT02678247|143263671|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|10.0||0.62|TWO_SIDED|95.0|-6.0|3.7||alpha = 0.05|t-test, 2 sided|paired t-test||||3.7|-6.0|0.62
71872925|NCT02678247|143263672|SUPERIORITY||Mean Difference (Final Values)|2.6|STANDARD_DEVIATION|5.7||0.07|TWO_SIDED|95.0|-0.2|5.3||alpha = 0.05|t-test, 2 sided|paired t-test||||5.3|-0.2|0.07
71872926|NCT02678247|143263673|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.3||0.18|TWO_SIDED|95.0|-5.4|1.1||alpha = 0.05|t-test, 2 sided|paired t-test||||1.1|-5.4|0.18
71872927|NCT02678247|143263674|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.3||0.47|TWO_SIDED|95.0|-0.4|0.9||alpha = 0.05|t-test, 2 sided|paired t-test||||0.9|-0.4|0.47
71872928|NCT02678247|143263675|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|3.5||0.68|TWO_SIDED|95.0|-1.4|2.0||alpha = 0.05|t-test, 2 sided|paired t-test||||2.0|-1.4|0.68
71872929|NCT04223856|143263732|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.377|0.538||P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.|Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.538|0.377|<0.00001
71872930|NCT04223856|143263733|SUPERIORITY|P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.01548.|Hazard Ratio (HR)|0.468|||<|1e-05|TWO_SIDED|95.0|0.376|0.582|||Log Rank||HR was calculated using stratified Cox proportional hazards model.|||0.582|0.376|<0.00001
71872931|NCT00081770|143263805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.567||95.0|0.79|1.14||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.14|0.79|0.567
71872932|NCT00081770|143263805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.195||95.0|0.9|1.3||Holm's method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs \>600,000 IU/mL) and race (Black vs non-Black).|||1.30|0.90|0.195
71872933|NCT00081770|143263807|SUPERIORITY_OR_OTHER||Percentage of participants|39.9||||||95.0|36.9|42.9|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||42.9|36.9|
71872934|NCT00081770|143263807|SUPERIORITY_OR_OTHER||Percentage of participants|36.0||||||95.0|33.1|39.0|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||39.0|33.1|
71872935|NCT00081770|143263807|SUPERIORITY_OR_OTHER||Percentage of participants|45.0||||||95.0|42.0|48.1|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12|||48.1|42.0|
71872936|NCT00601419|143263811|SUPERIORITY_OR_OTHER||||||=|0.556|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years and \>=65 years in the frequency of treatment related adverse events."||||=0.556
71872937|NCT00601419|143263812|SUPERIORITY_OR_OTHER||||||=|0.845|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."||||=0.845
71872938|NCT00601419|143263813|SUPERIORITY_OR_OTHER||||||=|0.038|TWO_SIDED||||||Fisher Exact|||"The null hypothesis is that there is no difference between With TSH deficiency and Without TSH deficiency in the frequency of treatment related adverse events."||||=0.038
71683267|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.76||0.0064|TWO_SIDED|95.0|-8.4|-1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 21||-1.4|-8.4|0.0064
71683268|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.77||0.0243|TWO_SIDED|95.0|-7.6|-0.5|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 28||-0.5|-7.6|0.0243
71872939|NCT00601419|143263814|SUPERIORITY_OR_OTHER||||||=|0.013|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past history. The null hypothesis is that there is no difference between With past history and Without past history in the frequency of treatment related adverse events."||||=0.013
71872940|NCT00601419|143263815|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no association between Initial Dose and the frequency of treatment related adverse events."||||=0.037
71872941|NCT00601419|143263815|SUPERIORITY_OR_OTHER||||||=|0.063|TWO_SIDED||||||Cochran-Armitage Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose."||||=0.063
71683269|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.2285|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 35||1.4|-6.0|0.2285
71683270|NCT03000530|142884881|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.86||0.212|TWO_SIDED|95.0|-6.0|1.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-D total score at each visit as the dependent variables.||Day 42||1.4|-6.0|0.2120
71683271|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0884|TWO_SIDED|95.0|0.8|24.1|||Generalized Estimating Equation|Statistics are from a generalized estimating equation (GEE) method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 2||24.1|0.8|0.0884
71683272|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|2.4||||0.0732|TWO_SIDED|95.0|0.9|6.4|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||6.4|0.9|0.0732
71872942|NCT00601419|143263817|SUPERIORITY_OR_OTHER||||||=|0.019|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between \<65 years of age and \>=65 years of age in the efficacy of somatropin."||||=0.019
71872943|NCT00601419|143263818|SUPERIORITY_OR_OTHER||||||=|1|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between male and female in the efficacy of somatropin."||||=1.000
71872944|NCT00601419|143263819|SUPERIORITY_OR_OTHER||||||=|0.037|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was ACTH deficiency. The null hypothesis is that there is no difference between With ACTH deficiency and Without ACTH deficiency in the efficacy of somatropin."||||=0.037
71872945|NCT02245672|143263823|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
71872946|NCT02245672|143263823|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established.For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
71872947|NCT02245672|143263824|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.12|||||TWO_SIDED|90.0|1.016|1.237|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for the FEV1 AUEC0-12 clinical endpoint|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.237|1.016|
71872948|NCT02245672|143263825|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||MGR001 (Test) vs Placebo||||<0.0001
71915271|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.389|TWO_SIDED|95.0|0.52|2.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||2.79|0.52|0.3890
71915272|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.7838||95.0|0.3|1.41||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||1.41|0.30|0.7838
71915273|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.237|TWO_SIDED|95.0|0.28|1.65||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \< 67.11 pg/mL (median)||1.65|0.28|0.2370
71915274|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.25||||0.0004||95.0|0.1|0.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe Baseline IL-6 \>= 67.11pg/mL (median)||0.59|0.10|0.0004
71915275|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.174|TWO_SIDED|95.0|0.37|1.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.32|0.37|0.1740
71683273|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|9.6||||0.0002|TWO_SIDED|95.0|2.9|31.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||31.6|2.9|0.0002
71915276|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.3664|TWO_SIDED|95.0|0.38|1.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||1.66|0.38|0.3664
71915277|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7318|TWO_SIDED|95.0|0.53|1.87||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \< 131.90 pg/mL (median)||1.87|0.53|0.7318
71872949|NCT02245672|143263825|SUPERIORITY|In order for the bioequivalence results to be valid, assay sensitivity had to be established. For assay sensitivity, the following comparisons were performed using the Full Analysis Set for each co-primary endpoint: MGR001 versus placebo, and Advair Diskus versus placebo. Assay sensitivity was demonstrated if the p-values for active treatment versus placebo were less than 0.05|||||<|0.0001|||||||ANCOVA|||Advair Diskus (Reference) vs Placebo||||<0.0001
71872950|NCT02245672|143263826|EQUIVALENCE|A linear analysis of covariance (ANCOVA) model was fitted for the endpoint and least-squares (LS) means were derived for each treatment. To assess equivalence, LS means (one for Test and one for Reference) from the ANCOVA models were used to generate Test/Reference ratios and 90% CIs were calculated by using Fieller's theorem. To demonstrate equivalence, the 90% CIs were each required to be wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).|Ratio (MGR001/Advair Diskus)|1.069|||||TWO_SIDED|90.0|0.938|1.22|||||Bioequivalence was established between active treatments (MGR001 and Advair Diskus) for change from baseline in trough FEV1 endpoint on Day 29|Equivalence of MGR001 and Advair Diskus is established if the ratio of the LS means and 90% confidence interval are wholly contained within the interval 0.80-1.25 (i.e., 80%-125%).||1.220|0.938|
71872951|NCT01097785|143263834|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
71872952|NCT01097785|143263835|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Student's t-test|||||||<0.05
71872953|NCT01765192|143263836|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.039||0.013|TWO_SIDED|95.0|0.0219|0.1795|||ANCOVA|||The primary endpoint was analyzed using an analysis of covariance model adapted for the crossover design. The following fixed factors and covariates were included in the model: Treatment, sequence, period, and baseline FEV1 measurement of the respective treatment period. The reported analysis results are for the 2 crossover treatment periods combined.||0.1795|0.0219|0.013
71872954|NCT01765192|143263837|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.129|TWO_SIDED|95.0|-0.0185|0.1422||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FVC measurement as the covariate.|ANCOVA|||||0.1422|-0.0185|0.129
71872955|NCT01765192|143263838|SUPERIORITY_OR_OTHER||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.032|TWO_SIDED|95.0|0.0113|0.2364||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FEF measurement as the covariate.|ANCOVA|||||0.2364|0.0113|0.032
71872956|NCT01765192|143263839|SUPERIORITY_OR_OTHER||LS Mean Difference|7.21|STANDARD_ERROR_OF_MEAN|15.105||0.635||95.0|-23.0531|37.466||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||37.4660|-23.0531|0.635
71872957|NCT01765192|143263840|SUPERIORITY_OR_OTHER||LS Mean Difference|13.62|STANDARD_ERROR_OF_MEAN|5.206||0.011|TWO_SIDED|95.0|3.1896|24.0553||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA|||||24.0553|3.1896|0.011
71872958|NCT01765192|143263841|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.089||0.025|TWO_SIDED|95.0|-0.385|-0.0271||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptom Score as the covariate.|ANCOVA|||||-0.0271|-0.3850|0.025
71872959|NCT01765192|143263842|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.075||0.217|TWO_SIDED|95.0|-0.2426|0.0563||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate.|ANCOVA|||||0.0563|-0.2426|0.217
71872960|NCT01535014|143263854|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71872961|NCT01535014|143263854|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71872962|NCT01535014|143263854|SUPERIORITY|||||||0.0007|||||||Cochran-Mantel-Haenszel|||||||0.0007
71872963|NCT01535014|143263855|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71872964|NCT01535014|143263855|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71915278|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4155|TWO_SIDED|95.0|0.59|2.37||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical Baseline IL-6 \>= 131.90 pg/mL (median)||2.37|0.59|0.4155
71915279|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.75||||0.6262|TWO_SIDED|95.0|0.23|2.45||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.45|0.23|0.6262
71872965|NCT01535014|143263856|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71872966|NCT01535014|143263856|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71872967|NCT01535014|143263857|SUPERIORITY||||||<|0.05||||||For week 12, 16, 20, 24|Chi-squared|||||||<0.05
71872968|NCT01535014|143263857|SUPERIORITY||||||<|0.05||||||For week 16, 20, 24|Chi-squared|||||||<0.05
71872969|NCT01535014|143263858|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
71872970|NCT01535014|143263858|SUPERIORITY|||||||0.043|||||||ANCOVA|||||||0.043
71872971|NCT01535014|143263859|SUPERIORITY|||||||0.2|||||||ANCOVA|||||||0.20
71872972|NCT01535014|143263859|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
71872973|NCT01535014|143263860|SUPERIORITY|||||||0.02|||||||ANCOVA|||SF-36 Mental Health Domain||||0.02
71872974|NCT01535014|143263860|SUPERIORITY|||||||0.63|||||||ANCOVA|||SF-36 Mental Health Domain||||0.63
71872975|NCT01535014|143263860|SUPERIORITY|||||||0.6|||||||ANCOVA|||SF-36 Physical Health Domain||||0.60
71872976|NCT01535014|143263860|SUPERIORITY|||||||0.98|||||||ANCOVA|||SF-36 Physical Health Domain||||0.98
71872977|NCT01215422|143263861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||>|0.05|ONE_SIDED|95.0|0.15||||Regression, Logistic||||||0.15|>0.05
71872978|NCT01215422|143263862|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||The p-value represents the comparison of the two interventions combined and compared against baseline for Grades III and IV summed together.|Fisher Exact|||||||0.03
71915280|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.553||95.0|0.21|2.3||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.30|0.21|0.5530
71872979|NCT01215422|143263865|SUPERIORITY_OR_OTHER||R-squared|0.16|||>|0.05||95.0||||Correlation between years of experience (all anesthesiologists, pooled) and time to intubation (both GS and KS VLSs, pooled)|Correlation|||||||>0.05
71872980|NCT02864381|143263873|SUPERIORITY||Odds Ratio (OR)|1.5||||0.8|TWO_SIDED|95.0|0.4|6.1||P-value is derived from Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification factor status.|Cochran-Mantel-Haenszel||Odds Ratio is derived from CMH test stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||6.1|0.4|0.8
71872981|NCT02864381|143263874|SUPERIORITY||Hazard Ratio (HR)|0.836||||0.306|TWO_SIDED|95.0|0.589|1.189||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.189|0.589|0.306
71872982|NCT02864381|143263875|SUPERIORITY||Hazard Ratio (HR)|0.786||||0.312|TWO_SIDED|95.0|0.491|1.257||P-value is derived from log-rank test stratified by PD-L1 stratification factor status.|Log Rank||Hazard ratio is derived from Cox model stratified by PD-L1 stratification factor status, the Nivolumab alone arm serves as the reference.|||1.257|0.491|0.312
71872983|NCT02113241|143263899|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
71872984|NCT02113241|143263899|SUPERIORITY|||||||0.089||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.089
71872985|NCT02113241|143263900|SUPERIORITY|||||||0.003||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.003
71872986|NCT02113241|143263900|SUPERIORITY|||||||0.248||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.248
71872987|NCT02113241|143263901|SUPERIORITY|||||||0.161||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.161
71872988|NCT02113241|143263901|SUPERIORITY|||||||0.079||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.079
71872989|NCT02113241|143263902|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.067
71872990|NCT02113241|143263902|SUPERIORITY|||||||0.918||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.918
71872991|NCT02113241|143263903|SUPERIORITY|||||||0.128||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.128
71872992|NCT02113241|143263903|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
71872993|NCT02113241|143263904|SUPERIORITY|||||||0.433|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.433
71872994|NCT02113241|143263904|SUPERIORITY|||||||0.407||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.407
71872995|NCT02113241|143263905|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
71872996|NCT02113241|143263905|SUPERIORITY|||||||0.826||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.826
71872997|NCT02113241|143263906|SUPERIORITY|||||||0.791||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.791
71872998|NCT02113241|143263906|SUPERIORITY|||||||0.413||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.413
71872999|NCT02113241|143263907|SUPERIORITY|||||||0.075||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.075
71873000|NCT02113241|143263907|SUPERIORITY|||||||0.432||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.432
71873001|NCT02113241|143263908|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
71873002|NCT02113241|143263908|SUPERIORITY|||||||0.835||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.835
71873003|NCT02113241|143263909|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
71873004|NCT02113241|143263909|SUPERIORITY|||||||0.778||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.778
71873005|NCT02113241|143263910|SUPERIORITY|||||||0.338||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.338
71873006|NCT02113241|143263910|SUPERIORITY|||||||0.309||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.309
71873007|NCT02113241|143263911|SUPERIORITY|||||||0.049||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.049
71873008|NCT02113241|143263911|SUPERIORITY|||||||0.563||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.563
71873009|NCT02113241|143263912|SUPERIORITY|||||||0.85||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.850
71873010|NCT02113241|143263912|SUPERIORITY|||||||0.206||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.206
71873011|NCT02113241|143263913|SUPERIORITY|||||||0.006||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.006
71873012|NCT02113241|143263913|SUPERIORITY|||||||0.95||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.950
71873013|NCT02113241|143263914|SUPERIORITY|||||||0.011||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.011
71873014|NCT02113241|143263914|SUPERIORITY|||||||0.454||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.454
71873015|NCT02113241|143263915|SUPERIORITY|||||||0.652||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.652
71873016|NCT02113241|143263915|SUPERIORITY|||||||0.055||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.055
71873017|NCT02113241|143263916|SUPERIORITY|||||||0.254||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.254
71873018|NCT02113241|143263916|SUPERIORITY|||||||0.787||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.787
71873019|NCT02113241|143263917|SUPERIORITY|||||||0.129||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.129
71873020|NCT02113241|143263917|SUPERIORITY|||||||0.365||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.365
71873021|NCT02113241|143263918|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||<0.001
71873022|NCT02113241|143263918|SUPERIORITY|||||||0.175||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.175
71873023|NCT02113241|143263919|SUPERIORITY|||||||0.392||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.392
71873024|NCT02113241|143263919|SUPERIORITY|||||||0.123|||||||Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.123
71873025|NCT02113241|143263920|SUPERIORITY|||||||0.176||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.176
71873026|NCT02113241|143263920|SUPERIORITY|||||||0.268||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.268
71873027|NCT02113241|143263921|SUPERIORITY|||||||0.064||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.064
71873028|NCT02113241|143263921|SUPERIORITY|||||||0.462||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.462
71873029|NCT02113241|143263922|SUPERIORITY|||||||0.346||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.346
71873030|NCT02113241|143263922|SUPERIORITY|||||||0.002||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Analysis between before and after the intervention||||0.002
71683274|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|6.7||||0.0006|TWO_SIDED|95.0|2.3|19.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||19.7|2.3|0.0006
71873031|NCT03249714|143263924|SUPERIORITY||Rate ratio|0.064|||<|0.001|TWO_SIDED|95.0|0.018|0.232|||negative binominal regression model|||||0.232|0.018|<0.001
71873032|NCT03249714|143263925|SUPERIORITY||rate ratio|0.136||||0.003|TWO_SIDED|95.0|0.036|0.513||Statistical significance (2-sided) at the 0.05 level|negative binomial regression|||||0.513|0.036|0.003
71873033|NCT03249714|143263925|SUPERIORITY||rate ratio|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0|||negative binominal regression|Indicates statistical significance (2-sided) at the 0.05 level.||||0.000|0.000|< 0.001
71873034|NCT03249714|143263926|SUPERIORITY||Rate ratio|0.284||||0.002|TWO_SIDED|95.0|0.13|0.62|||negative binominal regression|||||0.620|0.130|0.002
71873035|NCT03249714|143263927|SUPERIORITY||Rate ratio|0.42||||0.119|TWO_SIDED|95.0|0.141|1.25|||negative binominal regression|||||1.250|0.141|0.119
71873036|NCT01294683|143263987|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.654|TWO_SIDED|95.0|-1.434|0.936|||Miettinen and Nurminen|||Periods I/II||0.936|-1.434|0.654
71873037|NCT01294683|143263987|SUPERIORITY_OR_OTHER||Difference in Percentages|1.304||||0.09|TWO_SIDED|95.0|-0.427|3.768|||Miettinen and Nurminen|||Period III||3.768|-0.427|0.090
71873038|NCT01294683|143263988|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.206||||0.563|TWO_SIDED|95.0|-1.303|0.779|||Miettinen and Nurminen|||Periods I/II||0.779|-1.303|0.563
71683275|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0379|TWO_SIDED|95.0|1.1|8.9|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||8.9|1.1|0.0379
71683276|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|3.0||||0.0468|TWO_SIDED|95.0|1.0|9.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||9.0|1.0|0.0468
71683277|NCT03000530|142884882|SUPERIORITY||Odds Ratio (OR)|1.9||||0.2208|TWO_SIDED|95.0|0.7|5.6|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D response at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||5.6|0.7|0.2208
71873039|NCT01294683|143263988|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
71873040|NCT01294683|143263990|SUPERIORITY_OR_OTHER||Difference in Percentages|0.87||||0.166|TWO_SIDED|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III||3.118|-0.858|0.166
71873041|NCT01294683|143263993|SUPERIORITY_OR_OTHER||Difference in Percentages|0.617||||0.255|TWO_SIDED|95.0|-0.575|2.023|||Miettinen and Nurminen|||Periods I/II||2.023|-0.575|0.255
71873042|NCT01294683|143263993|SUPERIORITY_OR_OTHER||Difference in Percentages|0.395||||0.69|TWO_SIDED|95.0|-2.091|2.966|||Miettinen and Nurminen|||Period III||2.966|-2.091|0.690
71873043|NCT01294683|143263994|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-0.967|0.967|||Miettinen and Nurminen|||Periods I/II||0.967|-0.967|>0.999
71873044|NCT01294683|143263995|SUPERIORITY_OR_OTHER||Difference in Percentages|-1.029|||||TWO_SIDED|95.0|-7.301|5.252|||Miettinen and Nurminen||Miettinen and Nurminen Method|Periods I/II||5.252|-7.301|
71873045|NCT01294683|143263995|SUPERIORITY_OR_OTHER||Difference in Percentages|0.889|||||TWO_SIDED|95.0|-7.599|9.338|||||Miettinen and Nurminen Method|Period III||9.338|-7.599|
71873046|NCT01294683|143263996|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.412|||||TWO_SIDED|95.0|-4.28|3.45||||||Periods I/II||3.450|-4.280|
71873047|NCT01294683|143263996|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.533|||||TWO_SIDED|95.0|-3.916|2.619|||||Miettinen and Nurminen Method|Period III||2.619|-3.916|
71873048|NCT00412971|143264008|SUPERIORITY_OR_OTHER||difference in recurrence rate|0.25||||0.05|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.05
71873049|NCT01296347|143264018|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71873050|NCT01296347|143264019|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||6 weeks||||0.71
71683278|NCT03000530|142884883|SUPERIORITY||Odds Ratio (OR)|1.5||||0.43|TWO_SIDED|95.0|0.6|3.7|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||3.7|0.6|0.4300
71683279|NCT03000530|142884883|SUPERIORITY||Odds Ratio (OR)|5.3||||0.0005|TWO_SIDED|95.0|2.1|13.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||13.3|2.1|0.0005
71873051|NCT01296347|143264019|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||3 month||||1.0
71873052|NCT01296347|143264019|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||6 months||||0.32
71873053|NCT01296347|143264021|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71873054|NCT01296347|143264022|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71873055|NCT01296347|143264023|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71873056|NCT01296347|143264024|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71873057|NCT01585987|143264025|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.439||||0.0972|TWO_SIDED|80.0|1.085|1.908||Significance level used: 0.2|Log Rank||The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model|||1.908|1.085|0.0972
71873058|NCT01585987|143264026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.588||||0.0336|TWO_SIDED|80.0|1.199|2.103||Significance level used: 0.2|Log Rank|||||2.103|1.199|0.0336
71873059|NCT01585987|143264027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.874||||0.6433|TWO_SIDED|80.0|0.602|1.269||Significance level used: 0.2|Log Rank||HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.|||1.269|0.602|0.6433
71873060|NCT01585987|143264029|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0549||||0.3686|TWO_SIDED|80.0|0.7009|47.6447||Significance level used: 0.2|Cochran-Mantel-Haenszel|||||47.6447|0.7009|0.3686
71873061|NCT01783041|143264057|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
71873062|NCT01783041|143264058|OTHER||||||<|0.05||||||These are calculated p values.|Wilcoxon (Mann-Whitney)|This analysis applies to all sub-scales that were compared between the 2 study groups.||||||<0.05
71683280|NCT03000530|142884883|SUPERIORITY||Odds Ratio (OR)|3.1||||0.0172|TWO_SIDED|95.0|1.2|8.0|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||8.0|1.2|0.0172
71683281|NCT03000530|142884883|SUPERIORITY||Odds Ratio (OR)|2.9||||0.0221|TWO_SIDED|95.0|1.2|7.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||7.3|1.2|0.0221
71683282|NCT03000530|142884883|SUPERIORITY||Odds Ratio (OR)|1.4||||0.4139|TWO_SIDED|95.0|0.6|3.5|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||3.5|0.6|0.4139
71683283|NCT03000530|142884883|SUPERIORITY||Odds Ratio (OR)|1.7||||0.2332|TWO_SIDED|95.0|0.7|4.3|||Generalized Estimating Equation|Statistics are from a GEE method including the HAM-D remission at each visit as the dependent variables.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||4.3|0.7|0.2332
71683284|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.38||0.0836|TWO_SIDED|95.0|-5.1|0.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 2||0.3|-5.1|0.0836
71873063|NCT01783041|143264059|OTHER||||||<|0.05||||||Reported p values have been calculated.|t-test, 2 sided|Differences between the groups were analyzed using a two sided t-test.||||||<0.05
71873064|NCT01783041|143264060|OTHER||||||<|0.05||||||These are calculated p values.|ANOVA|Differences in continuous and categorical variables were compared using ANOVA and either Chi square test or Fisher's exact test, respectively.||||||<0.05
71873065|NCT02092220|143264066|SUPERIORITY||Mean Difference (Final Values)|-20.28|STANDARD_DEVIATION|24.59|<|0.0001|TWO_SIDED|95.0|-28.0|-12.56||Repeated measures model.|t-test, 2 sided||Bionic Pancreas Arm - Usual Care Arm|||-12.56|-28.00|<0.0001
71873066|NCT02092220|143264067|SUPERIORITY||Mean Difference (Final Values)|1.3|||<|0.0001|TWO_SIDED|95.0|0.8|1.8||Repeated measures model.|t-test, 2 sided|||||1.8|0.8|<0.0001
71873067|NCT01231516|143264127|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.4||||0.03|TWO_SIDED|95.0|0.7|14.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Adjusted difference in proportion which is based on the difference in percentage, adjusted for Baseline (BL) stratification factors.|Analysis was adjusted for BL stratification factors: HIV-1 RNA (\<=50000 versus \[vs\]\>50000 c/mL), darunavir-ritonavir use without primary protease inhibitor mutations (yes vs no), and phenotypic susceptibility score (2 vs \<2) to background regimen.|||14.2|0.7|0.030
71873068|NCT03170154|143264143|OTHER||1-sided 95% Upper CL|99.99|||||ONE_SIDED||||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 92.5 for the AAS at 12 months.|||||
71873069|NCT03170154|143264144|OTHER||1-sided 95% Upper CL|99.98|||||ONE_SIDED|95.0|||||||Historical comparison to EN ISO 11979-7:2014: SPE rate of at least 96.7 for the BAS at 12 months.|||||
71873070|NCT05266586|143264156|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
71873071|NCT05266586|143264157|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
71873072|NCT05266586|143264158|SUPERIORITY||Least Squares (LS) Means|-58.38|STANDARD_ERROR_OF_MEAN|5.138|<|0.0001|TWO_SIDED|95.0|-68.59|-48.18|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-48.18|-68.59|<.0001
71873073|NCT05266586|143264159|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
71873074|NCT05266586|143264160|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
71873075|NCT05266586|143264161|SUPERIORITY||Least Squares (LS) Means|-58.15|STANDARD_ERROR_OF_MEAN|5.195|<|0.0001|TWO_SIDED|95.0|-68.47|-47.83|||ANCOVA|||||-47.83|-68.47|<.0001
71873076|NCT05266586|143264162|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
71915281|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.8775|TWO_SIDED|95.0|0.25|2.85||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \< 254.95 pg/mL (median)||2.85|0.25|0.8775
71915282|NCT04315298|143351739|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.7485|TWO_SIDED|95.0|0.41|2.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD Baseline IL-6 \>= 254.95 pg/mL (median)||2.99|0.41|0.7485
71873077|NCT05266586|143264163|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
71873078|NCT05266586|143264164|SUPERIORITY||Least Squares (LS) Means|-38.35|STANDARD_ERROR_OF_MEAN|5.397|<|0.0001|TWO_SIDED|95.0|-49.07|-27.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.63|-49.07|<.0001
71873079|NCT05266586|143264165|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
71873080|NCT05266586|143264166|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
71873081|NCT05266586|143264167|SUPERIORITY||Least Squares (LS) Means|-37.21|STANDARD_ERROR_OF_MEAN|5.465|<|0.0001|TWO_SIDED|95.0|-48.07|-26.35|||ANCOVA|||||-26.35|-48.07|<.0001
71873082|NCT05266586|143264168|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
71873083|NCT05266586|143264169|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
71873084|NCT05266586|143264170|SUPERIORITY||Least Squares (LS) Means|-35.68|STANDARD_ERROR_OF_MEAN|3.8|<|0.0001|TWO_SIDED|95.0|-43.23|-28.13|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.13|-43.23|<.0001
71873085|NCT05266586|143264171|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
71915283|NCT04315298|143351740|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.4556|TWO_SIDED|95.0|0.63|1.79||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.79|0.63|0.4556
71873086|NCT05266586|143264172|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
71873087|NCT05266586|143264173|SUPERIORITY||Least Squares (LS) Means|-22.28|STANDARD_ERROR_OF_MEAN|3.991|<|0.0001|TWO_SIDED|95.0|-30.21|-14.36|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.36|-30.21|<.0001
71873088|NCT03622619|143264189|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71873089|NCT03622619|143264190|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71873090|NCT03622619|143264191|SUPERIORITY|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
71873091|NCT03622619|143264192|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Burning/stinging||||||0.90
71873092|NCT03622619|143264192|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Grittiness/foreign body sensation||||||0.30
71873093|NCT03622619|143264192|SUPERIORITY|||||||0.66||||||Dryness|Wilcoxon (Mann-Whitney)|||||||0.66
71873094|NCT03622619|143264192|SUPERIORITY|||||||0.14||||||Blurred vision|Wilcoxon (Mann-Whitney)|||||||0.14
71873095|NCT03622619|143264192|SUPERIORITY|||||||0.3||||||Overall discomfort|Wilcoxon (Mann-Whitney)|||||||0.30
71873096|NCT03226275|143264199|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.46|||||TWO_SIDED|90.0|93.25|106.09||||||Statistical Comparison of Bisoprolol in Fasting state||106.09|93.25|
71873097|NCT03226275|143264199|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|96.76|||||TWO_SIDED|90.0|92.95|100.73||||||Statistical Comparison of Amlodipine in Fasting State||100.73|92.95|
71873098|NCT03226275|143264199|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.95|||||TWO_SIDED|90.0|90.02|108.76||||||Statistical Comparison of Bisoprolol in Fed State||108.76|90.02|
71915284|NCT04315298|143351740|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0248|TWO_SIDED|95.0|0.35|1.04||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.04|0.35|0.0248
71915285|NCT04315298|143351740|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.6842|TWO_SIDED|95.0|0.62|1.67||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.67|0.62|0.6842
71873099|NCT03226275|143264199|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|103.07|||||TWO_SIDED|90.0|95.53|111.2||||||Statistical Comparison of Amlodipine in Fed State||111.20|95.53|
71873100|NCT03226275|143264200|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|97.85|||||TWO_SIDED|90.0|92.29|103.74||||||Statistical Comparison of Bisoprolol in Fasting State||103.74|92.29|
71873101|NCT03226275|143264200|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|100.03|||||TWO_SIDED|90.0|94.37|106.03||||||Statistical Comparison of Amlodipine in Fasting State||106.03|94.37|
71873102|NCT03226275|143264200|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|93.87|||||TWO_SIDED|90.0|84.56|104.2||||||Statistical Comparison of Bisoprolol in Fed State||104.20|84.56|
71873103|NCT03226275|143264200|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|106.56|||||TWO_SIDED|90.0|97.82|116.08||||||Statistical Comparison of Amlodipine in Fed State||116.08|97.82|
71873104|NCT03226275|143264201|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.13|||||TWO_SIDED|90.0|0.0|0.5||||||Statistical Comparison of Bisoprolol in Fasting State||0.50|0.00|
71873105|NCT03226275|143264201|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.0||||||Statistical Comparison of Amlodipine in Fasting State||0.00|-1.00|
71873106|NCT03226275|143264201|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Bisoprolol in Fed State||0.50|-1.00|
71873107|NCT03226275|143264201|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||TWO_SIDED|90.0|-1.0|0.5||||||Statistical Comparison of Amlodipine in Fed State||0.50|-1.00|
71873108|NCT03226275|143264203|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.98|||||TWO_SIDED|90.0|93.61|106.79||||||Statistical Comparison of Bisoprolol in Fasting State||106.79|93.61|
71873109|NCT03226275|143264203|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.68|||||TWO_SIDED|90.0|93.38|104.28||||||Statistical Comparison of Amlodipine in Fasting State||104.28|93.38|
71873110|NCT03226275|143264203|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.52|||||TWO_SIDED|90.0|89.75|108.15||||||Statistical Comparison of Bisoprolol in Fed State||108.15|89.75|
71873111|NCT03226275|143264203|EQUIVALENCE|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|104.06|||||TWO_SIDED|90.0|96.11|112.66||||||Statistical Comparison of Amlodipine in Fed State||112.66|96.11|
71873112|NCT01101477|143264217|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||The patients with at lease one episode of hypoxemia (SPaO2\<90%) during FB were analyzed by Chi-square test. P value less 0.05 means significance, 2-sided.||||0.05
71683285|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|2.32||0.0864|TWO_SIDED|95.0|-8.6|0.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 8||0.6|-8.6|0.0864
71873113|NCT02382016|143264223|SUPERIORITY||ratio of geometric means|0.65||||0.0001|TWO_SIDED|95.0|0.59|0.72|||ANCOVA|ANCOVA model adjusted by treatment, background PAH-specific therapy at baseline and region as factors \& log-transformed PVR at baseline as a covariate||The null hypothesis (change of PVR at Week 12 as a ratio of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed ratio of PVR at Week 12 to baseline PVR.||0.72|0.59|0.0001
71873114|NCT02382016|143264224|SUPERIORITY||Least squares (LS) mean difference|9.73||||0.4264|TWO_SIDED|95.0|-14.5|33.95||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|mixed-effect model repeated measure||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in 6MWD (LS mean difference macitentan 10 mg - placebo).|The main analysis on 6MWD was performed using a mixed-effect model repeated measure (MMRM) adjusted for treatment, visit, region, PAH-specific therapy at baseline, and treatment-by-visit interaction as factors, and baseline 6MWD and WHO functional class (FC) as covariates.||33.95|-14.50|0.4264
71873115|NCT02382016|143264225|SUPERIORITY||Odds Ratio (OR)|6.253||||0.1278|TWO_SIDED|95.0|0.714|298.376||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|Regression, Logistic|||A logistic regression model (exact) adjusted for treatment, PAH-specific therapy at baseline, and region as covariates was used to analyze worsening in WHO FC.||298.376|0.714|0.1278
71873116|NCT02382016|143264226|SUPERIORITY||ratio of geometric means|0.874||||0.3951|TWO_SIDED|95.0|0.639|1.196||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA|||||1.196|0.639|0.3951
71873117|NCT02382016|143264227|SUPERIORITY||Least squares (LS) mean difference|1.67||||0.0637|TWO_SIDED|95.0|-0.1|3.44||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mRAP (LS mean difference macitentan 10 mg - placebo).|||3.44|-0.10|0.0637
71873118|NCT02382016|143264228|SUPERIORITY||Least squares (LS) mean difference|-5.99||||0.0001|TWO_SIDED|95.0|-8.4|-3.57||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mPAP (LS mean difference macitentan 10 mg - placebo).|||-3.57|-8.40|0.0001
71873119|NCT02382016|143264229|SUPERIORITY||Least squares (LS) mean difference|0.52||||0.0009|TWO_SIDED|95.0|0.22|0.81||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in cardiac index (LS mean difference macitentan 10 mg - placebo).|||0.81|0.22|0.0009
71873120|NCT02382016|143264230|SUPERIORITY||Least squares (LS) mean difference|-171.48||||0.0001|TWO_SIDED|95.0|-223.67|-119.3||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in TPR (LS mean difference macitentan 10 mg - placebo).|||-119.30|-223.67|0.0001
71873121|NCT02382016|143264231|SUPERIORITY||Least squares (LS) mean difference|0.03||||0.9844|TWO_SIDED|95.0|-2.85|2.91||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in SVO2 (LS mean difference macitentan 10 mg - placebo).|||2.91|-2.85|0.9844
71873122|NCT00084266|143264232|NON_INFERIORITY_OR_EQUIVALENCE|The final p-value was compared against an O'Brien-Fleming boundary of 0.048.||||||0.042|TWO_SIDED||||||Chi-squared|||"Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as cure."||||0.042
71915286|NCT04315298|143351740|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.0671|TWO_SIDED|95.0|0.89|2.32||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.32|0.89|0.0671
71683286|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|2.38||0.0021|TWO_SIDED|95.0|-12.3|-2.8|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 15||-2.8|-12.3|0.0021
71683287|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.69||0.0157|TWO_SIDED|95.0|-12.0|-1.3|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 21||-1.3|-12.0|0.0157
71683288|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|2.69||0.0533|TWO_SIDED|95.0|-10.6|0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 28||0.1|-10.6|0.0533
71873123|NCT00084266|143264244|SUPERIORITY_OR_OTHER|||||||0.9344|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.9344
71915287|NCT04315298|143351740|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.6146|TWO_SIDED|95.0|0.41|1.74||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.74|0.41|0.6146
71915288|NCT04315298|143351740|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.973|TWO_SIDED|95.0|0.48|1.99||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.99|0.48|0.9730
71915289|NCT04315298|143351742|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.6987|TWO_SIDED|95.0|0.59|1.59||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.59|0.59|0.6987
71915290|NCT04315298|143351742|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0453|TWO_SIDED|95.0|0.39|1.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.09|0.39|0.0453
71683289|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|2.87||0.2878|TWO_SIDED|95.0|-8.8|2.6|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 35||2.6|-8.8|0.2878
71683290|NCT03000530|142884884|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|2.7||0.4664|TWO_SIDED|95.0|-7.4|3.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in MADRS total score at each visit as the dependent variable.||Day 42||3.4|-7.4|0.4664
71873124|NCT00084266|143264245|SUPERIORITY_OR_OTHER|||||||0.5985|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.5985
71873125|NCT00084266|143264246|SUPERIORITY_OR_OTHER|||||||0.859|TWO_SIDED||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.||||0.8590
71873126|NCT02901041|143264382|SUPERIORITY||Mean Difference (Net)|0.02||||0.98|TWO_SIDED|95.0|-1.41|1.45|||t-test, 2 sided|t=0.03, df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||1.45|-1.41|.98
71873127|NCT02901041|143264383|SUPERIORITY||Mean Difference (Net)|-0.83||||0.13|TWO_SIDED|95.0|-1.92|0.26|||t-test, 2 sided|t=-1.52, df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.26|-1.92|.13
71873128|NCT02901041|143264384|SUPERIORITY||Mean Difference (Net)|-0.07||||0.19|TWO_SIDED|95.0|-0.17|0.03||Equality of variance was not assumed.|t-test, 2 sided|t=-1.33, df=72.65||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.03|-0.17|.19
71873129|NCT02901041|143264385|SUPERIORITY||Mean Difference (Net)|-0.17||||0.05|TWO_SIDED|95.0|-0.34|0.0|||t-test, 2 sided|t=-1.99, df=56.00||||0.00|-0.34|.05
71873130|NCT02901041|143264386|SUPERIORITY||Mean Difference (Net)|0.03||||0.71|TWO_SIDED|95.0|-0.11|0.17|||t-test, 2 sided|t=0.37,df=79.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.17|-0.11|.71
71873131|NCT02901041|143264387|SUPERIORITY||Mean Difference (Net)|-0.11||||0.12|TWO_SIDED|95.0|-0.26|0.03|||t-test, 2 sided|t=-1.59,df=56.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.26|.12
71873132|NCT02901041|143264388|SUPERIORITY||Mean Difference (Net)|0.14||||0.98|TWO_SIDED|95.0|-9.89|10.18|||t-test, 2 sided|t=0.03, df=79.00||||10.18|-9.89|.98
71873133|NCT02901041|143264389|SUPERIORITY||Mean Difference (Net)|-5.8||||0.13|TWO_SIDED|95.0|-13.43|1.83|||t-test, 2 sided|t=-1.52, df=56.00||||1.83|-13.43|.13
71873134|NCT02901041|143264390|SUPERIORITY||Mean Difference (Net)|27.07||||0.75|TWO_SIDED|95.0|-144.06|198.2|||t-test, 2 sided|t=0.32,df=61.00||||198.20|-144.06|.75
71873135|NCT02901041|143264391|SUPERIORITY||Mean Difference (Net)|99.05||||0.35|TWO_SIDED|95.0|-111.11|309.21|||t-test, 2 sided|t=0.95, df=46.00||||309.21|-111.11|.35
71873136|NCT02901041|143264392|SUPERIORITY||Mean Difference (Net)|0.85||||0.51|TWO_SIDED|95.0|-1.69|3.4|||t-test, 2 sided|t=0.67, df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||3.40|-1.69|.51
71873137|NCT02901041|143264393|SUPERIORITY||Mean Difference (Net)|-0.42||||0.55|TWO_SIDED|95.0|-1.82|0.98|||t-test, 2 sided|t=-0.61,df=36||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.98|-1.82|.55
71915291|NCT04315298|143351742|SUPERIORITY||Hazard Ratio (HR)|1.23||||0.9734|TWO_SIDED|95.0|0.73|2.09||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.09|0.73|0.9734
71873138|NCT02901041|143264394|SUPERIORITY||Mean Difference (Net)|0.15||||0.95|TWO_SIDED|95.0|-4.15|4.45|||t-test, 2 sided|t=0.07,df=58.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||4.45|-4.15|.95
71873139|NCT02901041|143264395|SUPERIORITY||Mean Difference (Net)|3.34||||0.42|TWO_SIDED|95.0|-4.93|11.62|||t-test, 2 sided|t=0.82, df=38.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||11.62|-4.93|.42
71873140|NCT02901041|143264396|SUPERIORITY||Mean Difference (Net)|0.32||||0.17|TWO_SIDED|95.0|-0.15|0.8||Equal variance was not assumed.|t-test, 2 sided|t=1.39, df=36.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.80|-0.15|.17
71683291|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.87||0.0391|TWO_SIDED|95.0|-3.6|-0.1|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 2||-0.1|-3.6|0.0391
71873141|NCT02901041|143264397|SUPERIORITY||Mean Difference (Net)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.97||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.53, df=24.05||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.97|-0.14|0.14
71873142|NCT02901041|143264398|SUPERIORITY||Mean Difference (Net)|3.07||||0.14|TWO_SIDED|95.0|-1.03|7.16||Equal variances were not assumed when conducting the t-tests.|t-test, 2 sided|t=1.51,df=39.34||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||7.16|-1.03|.14
71873143|NCT02901041|143264399|SUPERIORITY||Mean Difference (Net)|3.18||||0.4|TWO_SIDED|95.0|-4.39|10.75||Equality of variance was not assumed.|t-test, 2 sided|t=0.85, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||10.75|-4.39|.40
71915292|NCT04315298|143351742|SUPERIORITY||Hazard Ratio (HR)|1.91||||0.004|TWO_SIDED|95.0|1.14|3.2||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No)|Log Rank|||Disease Severity: Critical||3.20|1.14|0.0040
71915293|NCT04315298|143351742|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.9551|TWO_SIDED|95.0|0.43|2.17||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.17|0.43|0.9551
71683292|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|1.29||0.0516|TWO_SIDED|95.0|-5.1|0.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 8||0.0|-5.1|0.0516
71873144|NCT02901041|143264400|SUPERIORITY||Mean Difference (Net)|0.4||||0.06|TWO_SIDED|95.0|-0.01|0.81||Equal variances were not assumed when conducting the t-test.|t-test, 2 sided|t=1.97, df=38.37||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.81|-0.01|.06
71873145|NCT02901041|143264401|SUPERIORITY||Mean Difference (Net)|0.03||||0.96|TWO_SIDED|95.0|-1.0|1.05|||t-test, 2 sided|t=.06, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||1.05|-1.00|.96
71873146|NCT02901041|143264402|SUPERIORITY||Mean Difference (Net)|2.03||||0.6|TWO_SIDED|95.0|-5.58|9.64|||t-test, 2 sided|t=0.53,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||9.64|-5.58|.60
71873147|NCT02901041|143264403|SUPERIORITY||Mean Difference (Net)|-0.06||||0.21|TWO_SIDED|95.0|-0.15|0.03|||t-test, 2 sided|t=-1.27, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.03|-0.15|.21
71873148|NCT02901041|143264404|SUPERIORITY||Mean Difference (Net)|-0.28||||0.09|TWO_SIDED|95.0|-0.6|0.04|||t-test, 2 sided|t=-1.74,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.04|-0.60|.09
71873149|NCT02901041|143264405|SUPERIORITY||Mean Difference (Net)|-0.35||||0.1|TWO_SIDED|95.0|-0.78|0.07|||t-test, 2 sided|t=-1.69, df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||0.07|-0.78|.10
71873150|NCT02901041|143264406|SUPERIORITY||Mean Difference (Net)|0.02||||0.8|TWO_SIDED|95.0|-0.15|0.19|||t-test, 2 sided|t=0.25,df=57.00||A t-test was used to compare means between conditions at baseline (pre-treatment). The null hypothesis was that the difference in group means is zero.||0.19|-0.15|0.80
71873151|NCT02901041|143264407|SUPERIORITY||Mean Difference (Net)|-5.61||||0.41|TWO_SIDED|95.0|-14.56|3.34|||t-test, 2 sided|t=-0.84,df=39.00||A t-test was used to compare means between conditions at baseline post-treatment. The null hypothesis was that the difference in group means is zero.||3.34|-14.56|.41
71873152|NCT01996813|143264415|SUPERIORITY||Odds Ratio (OR)|0.115||||0.0553|TWO_SIDED|95.0|0.002|1.034||The exact p-value was estimated|Regression, Logistic|The method was exact logistic regression||The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||1.034|0.002|.0553
71683293|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.32||0.0008|TWO_SIDED|95.0|-7.3|-2.0|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 15||-2.0|-7.3|0.0008
71873153|NCT01996813|143264416|SUPERIORITY||Mean Difference (Final Values)|40.31|||<|0.001|TWO_SIDED|95.0|20.22|60.39|||t-test, 2 sided|A Satterthwaite correction was used to adjust the degrees of freedom||The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position||60.39|20.22|<.001
71873154|NCT01942720|143264421|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|-0.7||||0.631|TWO_SIDED||||||Sperman test|||Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up||||0.631
71873155|NCT01942720|143264421|SUPERIORITY_OR_OTHER||Sperman correlation coeficient|0.022||||0.882|TWO_SIDED||||||Sperman correlation|||Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up||||0.882
71873156|NCT01942720|143264422|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.735|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit||||<0.001
71873157|NCT01942720|143264422|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.726|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit||||<0.001
71683294|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.54||0.0282|TWO_SIDED|95.0|-6.5|-0.4|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 21||-0.4|-6.5|0.0282
71873158|NCT01942720|143264423|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.493||||0.002|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up||||0.002
71873159|NCT01942720|143264423|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.531|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up||||<0.001
71873160|NCT01942720|143264424|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.752|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
71873161|NCT01942720|143264424|SUPERIORITY_OR_OTHER||Sperman correlation coefficient|0.785|||<|0.001|TWO_SIDED||||||Sperman correlation|||Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up||||<0.001
71873162|NCT03952806|143264426|SUPERIORITY||Least Square mean difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.4656|TWO_SIDED|95.0|-0.6|1.3|||Mixed Models Analysis|||||1.30|-0.60|0.4656
71915294|NCT04315298|143351742|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.8722|TWO_SIDED|95.0|0.42|2.1||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||2.10|0.42|0.8722
71915295|NCT04315298|143351745|SUPERIORITY|||||||1|||||||Chi-squared|||Disease Severity: Severe||||1.0000
71915296|NCT04315298|143351745|SUPERIORITY|||||||0.0353|||||||Chi-squared|||Disease Severity: Severe||||0.0353
71915297|NCT04315298|143351745|SUPERIORITY|||||||0.3187|||||||Chi-squared|||Disease Severity: Critical||||0.3187
71915298|NCT04315298|143351745|SUPERIORITY|||||||0.0261|||||||Chi-squared|||Disease Severity: Critical||||0.0261
71915299|NCT04315298|143351745|SUPERIORITY|||||||0.9117|||||||Chi-squared|||Disease Severity: MSOD||||0.9117
71873163|NCT00655863|143264437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-307.229|||<|0.001|TWO_SIDED|95.0|-443.168|-171.29||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-171.290|-443.168|<0.001
71873164|NCT00655863|143264437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-253.711|||<|0.001||95.0|-394.161|-113.262||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.||-113.262|-394.161|<0.001
71873165|NCT01138007|143264455|SUPERIORITY_OR_OTHER||Least Squared Mean Difference|-0.5||||0.853|TWO_SIDED|95.0|-2.7|1.7||The p-value was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates. The multiplicity was adjusted by Dunnett's step-down procedure.|ANCOVA||The confidence interval was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.|||1.7|-2.7|0.853
71873166|NCT01138007|143264455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|1.0||||95.0|||||||In the analysis plan, the second comparison of interest was not to be performed if the first comparison failed to show statistical significance.|||||
71873167|NCT01806129|143264482|SUPERIORITY||Odds Ratio (OR)|2.07|||||TWO_SIDED|90.0|1.29|3.31|||||Odds ratio represents the odds of adopting the appropriate reproductive health management for patients with intervention compared to the odds among patients without intervention. Odds ratio was calculated by GEE analysis.|||3.31|1.29|
71873168|NCT00744523|143264534|SUPERIORITY_OR_OTHER||proportion of the primary endpoint|2.7|STANDARD_ERROR_OF_MEAN|5.0|<|0.05|ONE_SIDED|95.0||5.2|||t-test, 1 sided||"Parameter Dispersion Type of Standard Error of the mean is meant to state that 'mean is the mean of proportions in the sense of a central-limit theorem"|The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).||5.2||<0.05
71873169|NCT03588728|143264594|SUPERIORITY|||||||0.781|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.781
71873170|NCT03588728|143264595|SUPERIORITY|||||||0.409|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.409
71873171|NCT03588728|143264596|SUPERIORITY|||||||0.697|||||||ANOVA|P value indicates the interaction term.||Test of between-subjects effects||||.697
71873172|NCT03588728|143264597|SUPERIORITY|||||||0.193|||||||ANOVA|P value indicates interaction term.||Test of between subjects effects||||.193
71873173|NCT03588728|143264598|SUPERIORITY|||||||0.185|||||||ANOVA|P value indicates the interaction term||Test of between-subjects effects||||.185
71873174|NCT03588728|143264599|SUPERIORITY|||||||0.198|||||||ANOVA|P value indicates the interaction term||Test of between-measures effects||||.198
71873175|NCT03588728|143264600|SUPERIORITY|||||||0.638|||||||ANOVA|||Test of between-subjects effects||||.638
71873176|NCT03588728|143264601|SUPERIORITY|||||||0.574|||||||ANOVA|p-value indicates the interaction term||Test of between-subjects effectd||||.574
71873177|NCT03588728|143264602|SUPERIORITY|||||||0.564|||||||ANOVA|P-value indicates the interaction term||Test of between-subjects effects||||.564
71873178|NCT03588728|143264603|SUPERIORITY|||||||0.998|||||||ANOVA|p-value indicates the interaction term||Tests of between-subjects effects||||.998
71683295|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.56||0.1686|TWO_SIDED|95.0|-5.3|0.9|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 28||0.9|-5.3|0.1686
71873179|NCT03588728|143264604|SUPERIORITY|||||||0.348|||||||ANOVA|P-value indicates the interaction term||Tests of between-subjecs effects||||.348
71873180|NCT01128894|143264624|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide - liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.|Mean Difference (Final Values)|0.21||||0.0846|TWO_SIDED|95.0|0.08|0.34|||ANCOVA|||||0.34|0.08|0.0846
71873181|NCT00195507|143264631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.64|-0.43|||ANCOVA|Treatment and center as main effects, and baseline score as a covariant.||||-0.43|-0.64|<0.001
71873182|NCT00195507|143264632|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71873183|NCT00195507|143264634|SUPERIORITY_OR_OTHER|||||||0.143|||||||Fisher Exact|||||||0.143
71873184|NCT00973362|143264635|SUPERIORITY_OR_OTHER||Sensitivity (%)|75.0|||||TWO_SIDED|95.0|53.1|88.8||||||||88.8|53.1|
71873185|NCT00973362|143264635|SUPERIORITY_OR_OTHER||Specificity (%)|62.6|||||TWO_SIDED|95.0|59.2|65.9||||||||65.9|59.2|
71873186|NCT00973362|143264635|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|4.8|||||TWO_SIDED|95.0|3.4|5.8||||||||5.8|3.4|
71873187|NCT00973362|143264635|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.0|||||TWO_SIDED|95.0|98.1|99.6||||||||99.6|98.1|
71873188|NCT00973362|143264635|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
71873189|NCT00973362|143264635|SUPERIORITY_OR_OTHER||Relative Risk|4.8|||||TWO_SIDED|95.0|1.8|13.1|||||The relative risk of CIN2+ is defined as the \[ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) \] .|||13.1|1.8|
71873190|NCT00973362|143264636|SUPERIORITY_OR_OTHER||Sensitivity (%)|84.2|||||TWO_SIDED|95.0|62.4|94.5||||||||94.5|62.4|
71873191|NCT00973362|143264636|SUPERIORITY_OR_OTHER||Specificity (%)|48.7|||||TWO_SIDED|95.0|45.2|52.2||||||||52.2|45.2|
71873192|NCT00973362|143264636|SUPERIORITY_OR_OTHER||Positive Predictive Value [PPV] (%)|3.8|||||TWO_SIDED|95.0|2.9|4.4||||||||4.4|2.9|
71873193|NCT00973362|143264636|SUPERIORITY_OR_OTHER||Negative Predictive Value [NPV] (%)|99.2|||||TWO_SIDED|95.0|98.1|99.8||||||||99.8|98.1|
71873194|NCT00973362|143264636|SUPERIORITY_OR_OTHER||Prevalence (%)|2.4|||||TWO_SIDED|||||||||||||
71915300|NCT04315298|143351745|SUPERIORITY|||||||0.7584|||||||Chi-squared|||Disease Severity: MSOD||||0.7584
71683296|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.75||0.2488|TWO_SIDED|95.0|-5.5|1.5|||Mixed Effect Model for Repeated Measures|||Day 35||1.5|-5.5|0.2488
71683297|NCT03000530|142884887|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.76||0.2037|TWO_SIDED|95.0|-5.7|1.2|||Mixed Effect Model for Repeated Measures|The MMRM included the change from baseline in HAM-A total score at each visit as the dependent variable.||Day 42||1.2|-5.7|0.2037
71683298|NCT03000530|142884888|SUPERIORITY||Odds Ratio (OR)|5.5||||0.0048|TWO_SIDED|95.0|1.7|17.9|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 8||17.9|1.7|0.0048
71683299|NCT03000530|142884888|SUPERIORITY||Odds Ratio (OR)|8.6||||0.0007|TWO_SIDED|95.0|2.5|29.5|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 15||29.5|2.5|0.0007
71683300|NCT03000530|142884888|SUPERIORITY||Odds Ratio (OR)|4.4||||0.0113|TWO_SIDED|95.0|1.4|13.6|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 21||13.6|1.4|0.0113
71683301|NCT03000530|142884888|SUPERIORITY||Odds Ratio (OR)|3.9||||0.0227|TWO_SIDED|95.0|1.2|12.8|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 28||12.8|1.2|0.0227
71683302|NCT03000530|142884888|SUPERIORITY||Odds Ratio (OR)|2.3||||0.1516|TWO_SIDED|95.0|0.7|7.2|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 35||7.2|0.7|0.1516
71683303|NCT03000530|142884888|SUPERIORITY||Odds Ratio (OR)|2.7||||0.0793|TWO_SIDED|95.0|0.9|8.3|||Generalized Estimating Equation|Statistics are from a GEE method including the CGI-I response at each visit as the dependent variable.|For the model parameters estimation, the exchangeable working correlation structure was used.|Day 42||8.3|0.9|0.0793
71873195|NCT00973362|143264636|SUPERIORITY_OR_OTHER||Relative Risk|4.9|||||TWO_SIDED|95.0|1.4|16.7|||||The relative risk of CIN2+ is defined as the \[ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) \] .|||16.7|1.4|
71873196|NCT00973362|143264637|SUPERIORITY_OR_OTHER||Sensitivity(%)|86.8|||||TWO_SIDED|95.0|78.4|92.3||||||||92.3|78.4|
71683304|NCT00625404|142884923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.52||||||Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is \> 0.3||1.52|0.59|
71683305|NCT00625404|142884924|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.||||0.45
71683306|NCT00625404|142884926|SUPERIORITY_OR_OTHER|||||||0.59|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.59
71683307|NCT00625404|142884927|SUPERIORITY_OR_OTHER|||||||0.79|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.79
71683308|NCT00625404|142884928|SUPERIORITY_OR_OTHER|||||||0.62|||||||Log Rank|||Log-rank test for difference in rates between groups||||0.62
71683309|NCT00625404|142884929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.89|||||||t-test, 2 sided|||t-test for difference on viral loads||||0.89
71683310|NCT00625404|142884930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.1||||0.82|||||||t-test, 2 sided|||t-test for difference in mean CD-4 counts||||0.82
71683311|NCT00625404|142884934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.73|||||||t-test, 2 sided|||t-test for difference in change in number of sexual partners over time||||0.73
71683312|NCT01887678|142884945|SUPERIORITY_OR_OTHER||Least Square|-6.37|STANDARD_ERROR_OF_MEAN|3.06||0.0383|TWO_SIDED|95.0|-12.4|-0.35|||ANCOVA||A negative value of the Least Square mean difference indicates a result in favor of Traumeel-Zeel.|||-0.35|-12.40|0.0383
71683313|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Squares|-2.15||||0.3715|TWO_SIDED|95.0|-6.89|2.58|||ANCOVA|||Day 8±1||2.58|-6.89|0.3715
71683314|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Square|-5.87||||0.0293|TWO_SIDED|95.0|-11.15|-0.6|||ANCOVA|||Day 15±1||-0.60|-11.15|0.0293
71683315|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Squares|-5.24||||0.0686|TWO_SIDED|95.0|-10.88|0.4|||ANCOVA|||Day 29±3||0.40|-10.88|0.0686
71683316|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Squares|-7.25||||0.015|TWO_SIDED|95.0|-13.08|-1.42|||ANCOVA|||Day 43±3||-1.42|-13.08|0.0150
71683317|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Squares|-7.56||||0.0134|TWO_SIDED|95.0|-13.54|-1.58|||ANCOVA|||Day 57±3||-1.58|-13.54|0.0134
71683318|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Squares|-7.6||||0.0121|TWO_SIDED|95.0|-13.52|-1.68|||Least Squares|||Day 71±3||-1.68|-13.52|0.0121
71873197|NCT00973362|143264637|SUPERIORITY_OR_OTHER||Specificty|62.9|||||TWO_SIDED|95.0|59.6|66.0||||||||66.0|59.6|
71873198|NCT00973362|143264637|SUPERIORITY_OR_OTHER||PPV|20.1|||||TWO_SIDED|95.0|18.1|22.0||||||||22.0|18.1|
71873199|NCT00973362|143264637|SUPERIORITY_OR_OTHER||NPV|97.8|||||TWO_SIDED|95.0|96.5|98.8||||||||98.8|96.5|
71873200|NCT00973362|143264637|SUPERIORITY_OR_OTHER||Prevalence (%)|9.7|||||TWO_SIDED|||||||||||||
71873201|NCT00973362|143264638|SUPERIORITY_OR_OTHER||Sensitivity (%)|88.8|||||TWO_SIDED|95.0|80.5|93.8||||||||93.8|80.5|
71873202|NCT00973362|143264638|SUPERIORITY_OR_OTHER||Specificity(%)|55.8|||||TWO_SIDED|95.0|52.3|59.3||||||||59.3|52.3|
71873203|NCT00973362|143264638|SUPERIORITY_OR_OTHER||PPV(%)|18.7|||||TWO_SIDED|95.0|17.0|20.4||||||||20.4|17.0|
71873204|NCT00973362|143264638|SUPERIORITY_OR_OTHER||NPV(%)|97.7|||||TWO_SIDED|95.0|96.2|98.8||||||||98.8|96.2|
71873205|NCT00973362|143264638|SUPERIORITY_OR_OTHER||Prevalence(%)|10.3|||||TWO_SIDED|||||||||||||
71873206|NCT01630434|143264651|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.091||||0.004|ONE_SIDED|95.0||-0.01|||Wald Method|||||-0.01||0.004
71873207|NCT01630434|143264651|NON_INFERIORITY|The non-inferiority margin, which is here taken to be 0.04.|difference of proportion|-0.038||||0.06|ONE_SIDED|95.0||0.045|||Wald Method|||||0.045||0.06
71873208|NCT01630434|143264652|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|-0.015||||0.0003|ONE_SIDED|95.0||0.016|||Wald Method|||||0.016||0.0003
71873209|NCT01630434|143264652|NON_INFERIORITY|The non-inferiority margin is 5%.|Difference of proportions|0.006||||0.027|ONE_SIDED|95.0||0.044|||Wald Method|||||0.044||0.027
71873210|NCT01630434|143264653|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.035||||0.118|ONE_SIDED|95.0||0.091|||Wald Method|||||0.091||0.118
71873211|NCT01630434|143264653|NON_INFERIORITY|The non-inferiority margin is 7.5%.|Difference of proportions|0.065||||0.389|ONE_SIDED|95.0||0.124|||Wald Method|||||0.124||0.389
71873212|NCT01630434|143264654|NON_INFERIORITY|The non-inferiority margin is 4%|Difference of proportions|0.043|||||ONE_SIDED|95.0||0.071||||||||0.071||
71873213|NCT01630434|143264654|NON_INFERIORITY|The non-inferiority margin is 4%.|Difference of proportions|0.054|||||ONE_SIDED|95.0||0.087||||||||0.087||
71873214|NCT01630434|143264655|NON_INFERIORITY|The non-inferiority margin is 0.7.|Mean Difference (Final Values)|-0.045|||<|0.0001|ONE_SIDED|95.0||0.047|||t-test, 2 sided|||||0.047||<0.0001
71873215|NCT00394953|143264671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.83|3.79|||Chi-squared, Corrected|||The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.||3.79|1.83|<0.0001
71873216|NCT01592864|143264751|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.2||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.2|-0.6|<0.0001
71873217|NCT01592864|143264752|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.3||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||-0.3|-0.6|<0.0001
71873218|NCT01592864|143264753|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.9|||<|0.0001|TWO_SIDED|95.0|11.1|22.8||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||22.8|11.1|<0.0001
71873219|NCT01592864|143264754|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.6|||<|0.0001|TWO_SIDED|95.0|5.4|13.9||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favors first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.||13.9|5.4|<0.0001
71915301|NCT04315298|143351749|SUPERIORITY||Hazard Ratio (HR)|0.32||||0.0385|TWO_SIDED|95.0|0.11|0.94||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||0.94|0.11|0.0385
71873220|NCT02858349|143264756|SUPERIORITY||Mean Difference (Net)|0.13||||0.0042|TWO_SIDED|95.0|0.05|0.21|||Mixed Models Analysis|||||0.21|0.05|0.0042
71873221|NCT02120716|143264769|OTHER|Logistic regression analysis.|Odds Ratio (OR)|5.5||||0.13|TWO_SIDED|95.0|0.6|51.2|||Regression, Logistic|||||51.2|0.6|0.13
71873222|NCT02120716|143264770|SUPERIORITY||Odds Ratio (OR)|11.7|||<|0.015|TWO_SIDED|95.0|4.2|33.0|||Regression, Logistic|||The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).||33.0|4.2|<0.015
71873223|NCT04079803|143264771|SUPERIORITY|||||||0.087||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0088 and CFB was 13.4. In percent change from baseline with these two subjects removed, P=0.004.|||0.087
71873224|NCT04079803|143264771|SUPERIORITY|||||||0.01||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0006 and CFB was 16.9. In percent change from baseline with this subject removed, P=0.0004.|||0.01
71683319|NCT01887678|142884946|SUPERIORITY_OR_OTHER||Least Squares|-6.32||||0.0376|TWO_SIDED|95.0|-12.28|-0.37|||ANCOVA|||Day 85±3||-0.37|-12.28|0.0376
71873225|NCT04079803|143264772|SUPERIORITY||||||<|0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P\<0.0001 and CFB was -19.8.|||<0.0001
71915302|NCT04315298|143351749|SUPERIORITY||Hazard Ratio (HR)|0.38||||0.0782|TWO_SIDED|95.0|0.14|1.05||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Severe||1.05|0.14|0.0782
71915303|NCT04315298|143351749|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2436|TWO_SIDED|95.0|0.7|2.14||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||2.14|0.70|0.2436
71683320|NCT01887678|142884947|SUPERIORITY_OR_OTHER||Least Squares|-4.76||||0.1373|TWO_SIDED|95.0|-11.05|1.53|||ANCOVA|||||1.53|-11.05|0.1373
71873226|NCT04079803|143264772|SUPERIORITY|||||||0.0012||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.001 and CFB was -14.9.|||0.0012
71873227|NCT04079803|143264773|SUPERIORITY|||||||0.005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.003 and CFB was -3.2.|||0.005
71873228|NCT04079803|143264773|SUPERIORITY|||||||0.002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.003 and CFB was -2.5.|||0.002
71873229|NCT04079803|143264774|SUPERIORITY|||||||0.0002||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -681.|||0.0002
71873230|NCT04079803|143264774|SUPERIORITY|||||||0.0005||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0005 and CFB was -527.|||0.0005
71873231|NCT04079803|143264775|SUPERIORITY|||||||0.0003||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0002 and CFB was -78.5.|||0.0003
71683321|NCT01887678|142884948|SUPERIORITY_OR_OTHER||Least Squares|-4.24||||0.1715|TWO_SIDED|95.0|-10.33|1.85|||ANCOVA|||||1.85|-10.33|0.1715
71683322|NCT01887678|142884949|SUPERIORITY_OR_OTHER||Least Squares|-4.77||||0.1211|TWO_SIDED|95.0|-10.82|1.27|||ANCOVA|||||1.27|-10.82|0.1211
71683323|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-4.97||||0.1128|TWO_SIDED|95.0|-11.12|1.18|||ANCOVA|||Day 8±1||1.18|-11.12|0.1128
71683324|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-10.49||||0.0013|TWO_SIDED|95.0|-16.85|-4.13|||ANCOVA|||Day 15±1||-4.13|-16.85|0.0013
71683325|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-6.89||||0.0472|TWO_SIDED|95.0|-13.69|-0.09|||ANCOVA|||Day 29±3||-0.09|-13.69|0.0472
71683326|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-8.82||||0.0109|TWO_SIDED|95.0|-15.6|-2.05|||ANCOVA|||Day 43±3||-2.05|-15.60|0.0109
71873232|NCT04079803|143264775|SUPERIORITY|||||||0.0058||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0008 and CFB was -51.0.|||0.0058
71873233|NCT04079803|143264776|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes two 100 mg subjects who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing two subjects with no detectable simufilam in plasma, P=0.0001 and CFB was -23.7.|||0.0001
71873234|NCT04079803|143264776|SUPERIORITY|||||||0.0001||||||P value adjusted for multiplicity of 6 co-primary endpoints (p\<0.008 required for significance).|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This primary analysis includes one 50 mg subject who showed no detectable simufilam in plasma at return visits (their exclusion was not prespecified in the Statistical Analysis Plan).|In a secondary analysis removing one subject with no detectable simufilam in plasma, P=0.0002 and CFB was -20.9.|||0.0001
71873235|NCT04079803|143264777|OTHER||Effect size|0.23|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
71873236|NCT04079803|143264777|OTHER||Effect size|0.37|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
71915304|NCT04315298|143351749|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3223|TWO_SIDED|95.0|0.46|1.51||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: Critical||1.51|0.46|0.3223
71915305|NCT04315298|143351749|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.467|TWO_SIDED|95.0|0.36|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.52|0.36|0.4670
71683327|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-8.88||||0.0123|TWO_SIDED|95.0|-15.8|-1.95|||ANCOVA|||Day 57±3||-1.95|-15.80|0.0123
71873237|NCT04079803|143264778|OTHER||Effect size|0.46|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was almost identical (0.45) when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
71873238|NCT04079803|143264778|OTHER||Effect size|0.25|||||TWO_SIDED||||||||Reported effect size vs. placebo was calculated with Hedge's g (for groups of 20 or fewer) but was identical when calculated by Cohen's d.|This study was not powered for statistical significance on cognitive measures.||||
71873239|NCT04079803|143264779|SUPERIORITY|||||||0.0078||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.0078
71873240|NCT04079803|143264779|SUPERIORITY|||||||0.019||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for IL-6.||||0.019
71873241|NCT04079803|143264779|SUPERIORITY|||||||0.0002||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0002
71873242|NCT04079803|143264779|SUPERIORITY|||||||0.0007||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for sTREM2.||||0.0007
71873243|NCT04079803|143264779|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
71873244|NCT04079803|143264779|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for HMGB1.||||0.0001
71873245|NCT04079803|143264779|SUPERIORITY|||||||0.0001||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.0001
71683328|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-6.88||||0.0425|TWO_SIDED|95.0|-13.52|-0.23|||ANCOVA|||Day 71±3||-0.23|-13.52|0.0425
71915306|NCT04315298|143351749|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.3728|TWO_SIDED|95.0|0.35|1.47||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||Disease Severity: MSOD||1.47|0.35|0.3728
71683329|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-5.51||||0.1199|TWO_SIDED|95.0|-12.47|1.45|||ANCOVA|||Day 85±3||1.45|-12.47|0.1199
71683330|NCT01887678|142884954|SUPERIORITY_OR_OTHER||Least Squares|-4.96||||0.1575|TWO_SIDED|95.0|-11.86|1.93|||ANCOVA|||Day 119±3||1.93|-11.86|0.1575
71683331|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6346|TWO_SIDED|95.0|-1.45|0.89|||ANCOVA|||Day 8±1||0.89|-1.45|0.6346
71683332|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.28||||0.6458|TWO_SIDED|95.0|-1.49|0.92|||ANCOVA|||Day 15±1||0.92|-1.49|0.6458
71683333|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.18||||0.7581|TWO_SIDED|95.0|-1.35|0.99|||ANCOVA|||Day 29±3||0.99|-1.35|0.7581
71915307|NCT04315298|143351755|SUPERIORITY||Risk Difference (RD)|2.7||||0.5851|TWO_SIDED|95.0|-7.0|12.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.4|-7.0|0.5851
71873246|NCT04079803|143264779|SUPERIORITY|||||||0.046||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for albumin.||||0.046
71873247|NCT04079803|143264779|SUPERIORITY|||||||0.012||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.012
71873248|NCT04079803|143264779|SUPERIORITY|||||||0.014||||||Secondary CSF biomarkers were not adjusted for multiplicity.|ANCOVA|General Linear Model for the analysis of covariance (ANCOVA) with a two-sided 95% confidence interval and baseline measurement as the covariate.||This analysis is for Immunoglobulin G.||||0.014
71873249|NCT04079803|143264780|SUPERIORITY|||||||0.005||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as the ratio of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.005
71873250|NCT04079803|143264780|SUPERIORITY|||||||0.009||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to alpha7nAChR in subject lymphocytes. FLNA linkage to alpha7nAChR was expressed as ratios of densitometric units of immunoblot bands of alpha7nAChR (probed with a specific antibody) to densitometric units of total FLNA.||||0.009
71873251|NCT04079803|143264780|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
71683334|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.49||||0.335|TWO_SIDED|95.0|-1.48|0.51|||ANCOVA|||Day 43±3||0.51|-1.48|0.3350
71873252|NCT04079803|143264780|SUPERIORITY|||||||0.01||||||As secondary endpoints, lymphocyte biomarkers were not adjusted for multiplicity.|ANOVA|ANOVA was used instead of ANCOVA due to the range in baseline values; it was deemed more appropriate to compare to each subject's own baseline value.||Change from baseline in FLNA linkage to TLR4 in subject lymphocytes. FLNA linkage to TLR4 was expressed as the ratio of densitometric units of immunoblot bands of TLR4 (probed with a specific antibody) to densitometric units of total FLNA.||||0.01
71873253|NCT04079803|143264781|SUPERIORITY|||||||0.01|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.01
71873254|NCT04079803|143264781|SUPERIORITY|||||||0.02|||||||ANOVA|ANOVA followed by Dunnett's multiple comparisons test.||||||0.02
71873255|NCT04079803|143264781|SUPERIORITY|||||||0.009|||||||ANOVA|This p value is for the main effect of treatment of the ANOVA.||||||0.009
71873256|NCT04079803|143264782|SUPERIORITY|||||||0.003|||||||ANOVA|||||||0.003
71873257|NCT04079803|143264782|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
71873258|NCT01881750|143264783|SUPERIORITY_OR_OTHER|||||||0.42|||||||Mixed Effects Regression Model|||Group X Time Interaction Cohen's d||||0.42
71873259|NCT04668586|143264801|SUPERIORITY||||||<|0.006|||||||Chi-squared|||||||<0.006
71873260|NCT04668586|143264802|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Adjusted for four-category stratification group.||||||0.008
71873261|NCT04668586|143264804|SUPERIORITY|||||||1|||||||Chi-squared|||||||1
71873262|NCT04668586|143264805|SUPERIORITY|||||||0.09|||||||Chi-squared, Corrected|Adjusted for four-category stratification group.||||||0.09
71873263|NCT01005459|143264870|OTHER|unpaired t-test|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
71873264|NCT01005459|143264870|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
71873265|NCT03282240|143264879|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.08|||||TWO_SIDED|95.0|0.958|1.224||||||B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.224|0.958|
71873266|NCT03282240|143264879|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.0|||||TWO_SIDED|95.0|0.881|1.129||||||B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.129|0.881|
71873267|NCT03282240|143264879|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.83|||||TWO_SIDED|95.0|0.744|0.932||||||A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||0.932|0.744|
71683335|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.4||||0.4419|TWO_SIDED|95.0|-1.44|0.63|||ANCOVA|||Day 57±3||0.63|-1.44|0.4419
71683336|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.37||||0.446|TWO_SIDED|95.0|-1.32|0.58|||ANCOVA|||Day 71±3||0.58|-1.32|0.4460
71683337|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|0.25||||0.6552|TWO_SIDED|95.0|-0.84|1.33|||ANCOVA|||Day 85±3||1.33|-0.84|0.6552
71683338|NCT01887678|142884955|SUPERIORITY_OR_OTHER||Least Squares|-0.19||||0.7443|TWO_SIDED|95.0|-1.33|0.95|||ANCOVA|||Day 119±3||0.95|-1.33|0.7443
71873268|NCT03282240|143264879|NON_INFERIORITY|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is \> 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.95|||||TWO_SIDED|95.0|0.842|1.066||||||A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||1.066|0.842|
71873269|NCT03282240|143264880|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-2.41|||||TWO_SIDED|95.0|-7.66|2.7||||||B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||2.70|-7.66|
71873270|NCT03282240|143264880|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-1.75|||||TWO_SIDED|95.0|-7.04|3.53||||||B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.53|-7.04|
71873271|NCT03282240|143264880|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-0.71|||||TWO_SIDED|95.0|-4.83|3.42||||||A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||3.42|-4.83|
71873272|NCT03282240|143264880|NON_INFERIORITY|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is \> -10%.|Difference in Percentage|-3.27|||||TWO_SIDED|95.0|-7.37|0.86||||||A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.||0.86|-7.37|
71873273|NCT03282240|143264881|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.04|||||TWO_SIDED|95.0|1.804|2.315||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.315|1.804|
71915308|NCT04315298|143351755|SUPERIORITY||Risk Difference (RD)|-2.6||||0.5767|TWO_SIDED|95.0|-11.7|6.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.5|-11.7|0.5767
71683339|NCT01887678|142884960|SUPERIORITY_OR_OTHER|||||||0.2164|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After first injection of study drug||||0.2164
71683340|NCT01887678|142884960|SUPERIORITY_OR_OTHER|||||||0.1651|TWO_SIDED|||||Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions|Log Rank|||After second injection of study drug||||0.1651
71683341|NCT01887678|142884960|SUPERIORITY_OR_OTHER|||||||0.222|TWO_SIDED||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After third injection of study drug||||0.2220
71683342|NCT01887678|142884961|SUPERIORITY_OR_OTHER|||||||0.0264|TWO_SIDED||||||Log Rank|For equality of survival functions||After first injection of study drug||||0.0264
71683343|NCT01887678|142884961|SUPERIORITY_OR_OTHER|||||||0.0346|TWO_SIDED||||||Log Rank|For equality of survival functions||After second injection of study drug||||0.0346
71683344|NCT01887678|142884961|SUPERIORITY_OR_OTHER|||||||0.0172|TWO_SIDED||||||Log Rank|For equality of survival functions||After third injection of study drug||||0.0172
71683345|NCT00678470|142885030|OTHER||Correlation|1.0||||0.0003|TWO_SIDED||||||Fisher Exact||||Using Fisher's non-parametric test of associations, correlations were determined between the patients who were intralesional responders with their response at ‡70% change in PASI score.|||0.0003
71683346|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3375||||||P-value is for Physical Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an Analysis of Covariance (ANCOVA) for change from baseline. Covariates include: treatment and baseline value.||||||0.3375
71873274|NCT03282240|143264881|SUPERIORITY|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was \> 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.03|||||TWO_SIDED|95.0|1.802|2.288||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.||2.288|1.802|
71873275|NCT03282240|143264883|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|29.27|||||TWO_SIDED|95.0|24.78|33.29||||||B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||33.29|24.78|
71873276|NCT03282240|143264883|SUPERIORITY|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is \> 10% for each applicable comparison.|Difference in Percentage|20.78|||||TWO_SIDED|95.0|16.5|24.61||||||B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.||24.61|16.5|
71683347|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.516||||||P-value is for Physical Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.516
71873277|NCT02910739|143264894|OTHER|The pharmacokinetic condition to initiate Part 2 of the study would be met if the point estimate for the AUC0-∞ ratio of geometric means (participants with moderate HI / healthy matched control participants) exceeds 1.5.|Geometric least-squares mean ratio (GMR)|1.04|||||TWO_SIDED|90.0|0.83|1.3|||||GMR = geometric least squares mean (GLSM) for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-∞; no hypothesis testing was planned for this outcome measure.||1.30|0.83|
71873278|NCT02910739|143264895|OTHER||GMR|1.07|||||TWO_SIDED|90.0|0.77|1.5|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on Cmax; no hypothesis testing was planned for this outcome measure.||1.50|0.77|
71873279|NCT02910739|143264896|OTHER||GMR|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-last; no hypothesis testing was planned for this outcome measure.||1.31|0.82|
71873280|NCT02910739|143264897|OTHER||GMR|1.01|||||TWO_SIDED|90.0|0.8|1.27|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-24hr; no hypothesis testing was planned for this outcome measure.||1.27|0.80|
71873281|NCT02910739|143264898|OTHER||GMR|1.08|||||TWO_SIDED|90.0|0.9|1.3|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on C24hr; no hypothesis testing was planned for this outcome measure.||1.30|0.90|
71683348|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.786||||||P-value is for Physical Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.786
71683349|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1496||||||P-value is for Physical Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1496
71683350|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8428||||||P-value is for Physical Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8428
71683351|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7345||||||P-value is for Physical Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7345
71683352|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8928||||||P-value is for Physical Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8928
71683353|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7343||||||P-value is for Physical Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7343
71683354|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8798||||||P-value is for Social/Family Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8798
71873282|NCT02146326|143264905|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
71683355|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6837||||||P-value is for Social/Family Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6837
71683356|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7226||||||P-value is for Social/Family Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7226
71873283|NCT02146326|143264906|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.80
71873284|NCT02146326|143264907|SUPERIORITY|||||||0.54|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.54
71915309|NCT04315298|143351756|SUPERIORITY||Risk Difference (RD)|5.2||||0.4777|TWO_SIDED|95.0|-9.4|18.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.6|-9.4|0.4777
71683357|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.641||||||P-value is for Social/Family Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.641
71873285|NCT02146326|143264908|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.94
71873286|NCT02146326|143264909|SUPERIORITY|||||||0.96|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.96
71873287|NCT02146326|143264910|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
71873288|NCT02146326|143264911|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.47
71873289|NCT02146326|143264912|SUPERIORITY|||||||0.6|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.60
71873290|NCT02146326|143264913|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
71873291|NCT02146326|143264914|SUPERIORITY|||||||0.83|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.83
71873292|NCT02146326|143264915|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
71873293|NCT02146326|143264916|SUPERIORITY|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.37
71873294|NCT02146326|143264917|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.13
71873295|NCT02146326|143264918|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.93
71873296|NCT02146326|143264919|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
71873297|NCT02146326|143264920|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.21
71873298|NCT02146326|143264922|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.17
71873299|NCT02146326|143264923|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|||||||0.24
71873300|NCT02146326|143264924|SUPERIORITY|||||||0.35|||||||Chi-squared|||||||0.35
71873301|NCT02146326|143264925|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
71915310|NCT04315298|143351756|SUPERIORITY||Risk Difference (RD)|5.7||||0.4202|TWO_SIDED|95.0|-8.4|18.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.2|-8.4|0.4202
71683358|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.478||||||P-value is for Social/Family Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.478
71683359|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9367||||||P-value is for Social/Family Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.9367
71683360|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5108||||||P-value is for Social/Family Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5108
71873302|NCT02146326|143264926|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.04
71683361|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8976||||||P-value is for Social/Family Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8976
71683362|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8193||||||P-value is for Emotional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8193
71683363|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1695||||||P-value is for Emotional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1695
71683364|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4021||||||P-value is for Emotional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.4021
71683365|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3603||||||P-value is for Emotional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3603
71683366|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5169||||||P-value is for Emotional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.5169
71873303|NCT02146326|143264927|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.34
71873304|NCT02146326|143264928|SUPERIORITY|||||||0.71|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.71
71873305|NCT02146326|143264929|SUPERIORITY|||||||0.22|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.22
71683367|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1642||||||P-value is for Emotional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1642
71873306|NCT02146326|143264930|SUPERIORITY|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.11
71683368|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6354||||||P-value is for Emotional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.6354
71683369|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3517||||||P-value is for Emotional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3517
71915311|NCT04315298|143351757|SUPERIORITY||Risk Difference (RD)|0.2||||0.9696|TWO_SIDED|95.0|-9.5|9.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||9.9|-9.5|0.9696
71915312|NCT04315298|143351757|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3152|TWO_SIDED|95.0|-13.8|4.4||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.4|-13.8|0.3152
71915313|NCT04315298|143351758|SUPERIORITY||Risk Difference (RD)|-7.7||||0.3217|TWO_SIDED|95.0|-22.8|7.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.2|-22.8|0.3217
71915314|NCT04315298|143351758|SUPERIORITY||Risk Difference (RD)|-5.5||||0.463|TWO_SIDED|95.0|-20.2|8.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||8.7|-20.2|0.4630
71915315|NCT04315298|143351758|SUPERIORITY||Risk Difference (RD)|-13.3||||0.0971|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.0971
71915316|NCT04315298|143351758|SUPERIORITY||Risk Difference (RD)|-11.9||||0.1193|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.1193
71915317|NCT04315298|143351759|SUPERIORITY||Risk Difference (RD)|-0.6||||0.8844|TWO_SIDED|95.0|-9.3|7.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||7.7|-9.3|0.8844
71915318|NCT04315298|143351759|SUPERIORITY||Risk Difference (RD)|5.2||||0.2247|TWO_SIDED|95.0|-3.3|13.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 29||13.0|-3.3|0.2247
71915319|NCT04315298|143351759|SUPERIORITY||Risk Difference (RD)|-13.3||||0.2102|TWO_SIDED|95.0|-28.2|2.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.3|-28.2|0.2102
71915320|NCT04315298|143351759|SUPERIORITY||Risk Difference (RD)|-11.9||||0.8292|TWO_SIDED|95.0|-26.4|2.9||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||Through Day 60||2.9|-26.4|0.8292
71915321|NCT04315298|143351760|SUPERIORITY||Risk Difference (RD)|9.8||||0.2203|TWO_SIDED|95.0|-6.0|24.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||24.3|-6.0|0.2203
71915322|NCT04315298|143351760|SUPERIORITY||Risk Difference (RD)|8.8||||0.2483|TWO_SIDED|95.0|-6.1|22.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||22.6|-6.1|0.2483
71915323|NCT04315298|143351761|SUPERIORITY||Risk Difference (RD)|4.1||||0.602|TWO_SIDED|95.0|-11.2|18.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||18.5|-11.2|0.6020
71915324|NCT04315298|143351761|SUPERIORITY||Risk Difference (RD)|5.9||||0.4342|TWO_SIDED|95.0|-8.9|19.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||19.5|-8.9|0.4342
71915325|NCT04315298|143351762|SUPERIORITY||Risk Difference (RD)|5.2||||0.2896|TWO_SIDED|95.0|-4.3|14.7||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||14.7|-4.3|0.2896
71915326|NCT04315298|143351762|SUPERIORITY||Risk Difference (RD)|-2.9||||0.5355|TWO_SIDED|95.0|-11.8|6.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||6.2|-11.8|0.5355
71915327|NCT04315298|143351763|SUPERIORITY||Risk Difference (RD)|0.5||||0.921|TWO_SIDED|95.0|-9.2|10.2||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.2|-9.2|0.9210
71915328|NCT04315298|143351763|SUPERIORITY||Risk Difference (RD)|-4.7||||0.3174|TWO_SIDED|95.0|-13.8|4.5||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.5|-13.8|0.3174
71915329|NCT04315298|143351764|SUPERIORITY||Hazard Ratio (HR)|1.62||||0.0705|TWO_SIDED|95.0|0.98|2.66||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.66|0.98|0.0705
71915330|NCT04315298|143351764|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.18|TWO_SIDED|95.0|0.92|2.43||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.43|0.92|0.1800
71915331|NCT04315298|143351765|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.1831|TWO_SIDED|95.0|0.91|1.52||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.52|0.91|0.1831
71915332|NCT04315298|143351765|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.877|TWO_SIDED|95.0|0.82|1.34||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||1.34|0.82|0.8770
71915333|NCT04315298|143351766|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7103|TWO_SIDED|95.0|0.35|2.06||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.06|0.35|0.7103
71915334|NCT04315298|143351767|SUPERIORITY||Hazard Ratio (HR)|1.47||||0.1512|TWO_SIDED|95.0|0.89|2.43||P-value from stratified log-rank test|Log Rank|||||2.43|0.89|0.1512
71915335|NCT04315298|143351767|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.2952|TWO_SIDED|95.0|0.85|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.85|0.2952
71915336|NCT04315298|143351768|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2297|TWO_SIDED|95.0|0.89|1.5||P-value from stratified log-rank test|Log Rank|||||1.50|0.89|0.2297
71915337|NCT04315298|143351768|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.8651|TWO_SIDED|95.0|0.79|1.3||P-value from stratified log-rank test|Log Rank|||||1.30|0.79|0.8651
71915338|NCT04315298|143351769|SUPERIORITY||Risk Difference (RD)|-1.0||||0.8864|TWO_SIDED|95.0|-15.2|12.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||12.1|-15.2|0.8864
71915339|NCT04315298|143351769|SUPERIORITY||Risk Difference (RD)|-2.1||||0.75|TWO_SIDED|95.0|-15.8|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-15.8|0.7500
71915340|NCT04315298|143351770|SUPERIORITY||Risk Difference (RD)|-1.5||||0.6858|TWO_SIDED|95.0|-9.1|5.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||5.6|-9.1|0.6858
71915341|NCT04315298|143351770|SUPERIORITY||Risk Difference (RD)|0.4||||0.9173|TWO_SIDED|95.0|-7.0|7.0||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||7.0|-7.0|0.9173
71915342|NCT04315298|143351771|SUPERIORITY||Risk Difference (RD)|4.5||||0.5239|TWO_SIDED|95.0|-9.7|17.3||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||17.3|-9.7|0.5239
71915343|NCT04315298|143351771|SUPERIORITY||Risk Difference (RD)|3.7||||0.5809|TWO_SIDED|95.0|-10.0|15.6||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||15.6|-10.0|0.5809
71915344|NCT04315298|143351772|SUPERIORITY||Risk Difference (RD)|0.4||||0.9343|TWO_SIDED|95.0|-9.3|10.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||10.1|-9.3|0.9343
71915345|NCT04315298|143351772|SUPERIORITY||Risk Difference (RD)|-5.0||||0.2822|TWO_SIDED|95.0|-14.1|4.1||P-value based on stratified Cochran-Mantel-Haenszel test using the strata Use of Steroids at Baseline.|Cochran-Mantel-Haenszel|||||4.1|-14.1|0.2822
71915346|NCT04315298|143351773|SUPERIORITY||Hazard Ratio (HR)|1.28||||0.4519|TWO_SIDED|95.0|0.75|2.18||P-value from stratified log-rank test|Log Rank|||||2.18|0.75|0.4519
71915347|NCT04315298|143351773|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.2818|TWO_SIDED|95.0|0.81|2.24||P-value from stratified log-rank test|Log Rank|||||2.24|0.81|0.2818
71915348|NCT04315298|143351774|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.4674|TWO_SIDED|95.0|0.84|1.43||P-value from stratified log-rank test|Log Rank|||||1.43|0.84|0.4674
71915349|NCT04315298|143351774|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.8503|TWO_SIDED|95.0|0.77|1.28||P-value from stratified log-rank test.|Log Rank|||||1.28|0.77|0.8503
71915350|NCT04315298|143351775|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.6156|TWO_SIDED|95.0|0.31|2.02||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.02|0.31|0.6156
71915351|NCT04315298|143351776|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0843|TWO_SIDED|95.0|0.41|1.03||P-value from stratified log-rank test|Log Rank|||||1.03|0.41|0.0843
71915352|NCT04315298|143351776|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.1576|TWO_SIDED|95.0|0.44|1.07||P-value from stratified log-rank test|Log Rank|||||1.07|0.44|0.1576
71915353|NCT04315298|143351777|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.198|TWO_SIDED|95.0|0.57|1.14||P-value from stratified log-rank test|Log Rank|||||1.14|0.57|0.1980
71915354|NCT04315298|143351777|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.7973|TWO_SIDED|95.0|0.73|1.36||P-value from stratified log-rank test.|Log Rank|||||1.36|0.73|0.7973
71683370|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7605||||||P-value is for Functional Well-Being Cycle 1.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7605
71915355|NCT04315298|143351778|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.5023|TWO_SIDED|95.0|0.13|2.75||P-value based on log-rank test stratified by use of systemic corticosteroids for COVID-19 (Yes, No).|Log Rank|||||2.75|0.13|0.5023
71915356|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|0.3|STANDARD_ERROR_OF_MEAN|0.26||0.2804|TWO_SIDED|95.0|-0.2|0.8||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.8|-0.2|0.2804
71915357|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.5023|TWO_SIDED|95.0|-0.5|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.3|-0.5|0.5023
71915358|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.3821|TWO_SIDED|95.0|-0.7|1.9||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.9|-0.7|0.3821
71915359|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|0.0|STANDARD_ERROR_OF_MEAN|0.59||0.9737|TWO_SIDED|95.0|-1.2|1.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.1|-1.2|0.9737
71915360|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|1.2|STANDARD_ERROR_OF_MEAN|1.15||0.3179|TWO_SIDED|95.0|-1.1|3.4||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||3.4|-1.1|0.3179
71915361|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|0.5|STANDARD_ERROR_OF_MEAN|1.03||0.6302|TWO_SIDED|95.0|-1.5|2.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.5|-1.5|0.6302
71915362|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|1.8|STANDARD_ERROR_OF_MEAN|1.64||0.2862|TWO_SIDED|95.0|-1.5|5.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||5.0|-1.5|0.2862
71915363|NCT04315298|143351779|SUPERIORITY||Risk Difference (RD)|1.1|STANDARD_ERROR_OF_MEAN|1.49||0.4509|TWO_SIDED|95.0|-1.8|4.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||4.1|-1.8|0.4509
71915364|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|-0.2|STANDARD_ERROR_OF_MEAN|0.33||0.564|TWO_SIDED|95.0|-0.8|0.5||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.5|-0.8|0.5640
71915365|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|0.31||0.1602|TWO_SIDED|95.0|-1.0|0.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 8||0.2|-1.0|0.1602
71915366|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|-0.1|STANDARD_ERROR_OF_MEAN|0.64||0.9144|TWO_SIDED|95.0|-1.3|1.2||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||1.2|-1.3|0.9144
71915367|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|-0.9|STANDARD_ERROR_OF_MEAN|0.61||0.145|TWO_SIDED|95.0|-2.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 15||0.3|-2.1|0.1450
71915368|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|0.95||0.8378|TWO_SIDED|95.0|-1.7|2.1||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||2.1|-1.7|0.8378
71915369|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|-1.2|STANDARD_ERROR_OF_MEAN|0.89||0.1988|TWO_SIDED|95.0|-2.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 22||0.6|-2.9|0.1988
71873307|NCT02146326|143264931|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
71873308|NCT02146326|143264932|SUPERIORITY|||||||0.55|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.55
71873309|NCT02146326|143264933|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.91
71873310|NCT02146326|143264934|SUPERIORITY|||||||0.48|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.48
71873311|NCT02146326|143264935|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.67
71873312|NCT02146326|143264936|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.77
71873313|NCT02146326|143264937|SUPERIORITY|||||||0.59|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.59
71873314|NCT02146326|143264938|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.64
71873315|NCT02146326|143264939|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.05
71873316|NCT02146326|143264940|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.06
71683371|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3747||||||P-value is for Functional Well-Being Cycle 2.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3747
71873317|NCT02146326|143264941|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.84
71873318|NCT02146326|143264942|SUPERIORITY|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.14
71873319|NCT02146326|143264943|SUPERIORITY|||||||0.45|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.||||0.45
71873320|NCT02181387|143264954|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
71873321|NCT02181387|143264954|OTHER|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups|||||||>0.05
71873322|NCT03602261|143264990|OTHER|||||||0.5536|||||||Fisher Exact|||||||0.5536
71873323|NCT03081052|143265011|EQUIVALENCE|We estimated sample size based on equivalence test of the incidence rates of a binary outcome (e.g. PGD grade 3 (PGD-3)) of two treatment groups as an illustration. Assuming the incidence rate of PGD-3 under iEPO treatment is 0.30 and acceptable margin of the equivalence is ± 0.19, we will need 200 lung transplant patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.049||||0.019|TWO_SIDED|90.0|-0.064|0.162|||two one sided test p-value|||||0.162|-0.064|0.019
71683372|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8379||||||P-value is for Functional Well-Being Cycle 3.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.8379
71873324|NCT03081052|143265012|NON_INFERIORITY|We estimated sample size based on equivalence test of the incidence rates of a binary outcome of two treatment groups as an illustration. Assuming the incidence rate of moderate or severe RV failure under iEPO treatment is 0.113 and acceptable margin of the equivalence is ± 0.15, we will need 224 heart failure patients to have 80% power to detect an actual difference at α=0.05 between two treatment group under this margin.|Risk Difference (RD)|0.025||||0.012|TWO_SIDED|90.0|-0.066|0.116|||two one-sided test p-value|||||0.116|-0.066|0.012
71873325|NCT03081052|143265013|OTHER||Hodges-Lehmann Location Shift|0.0||||0.747|TWO_SIDED|95.0|-3.0|3.0|||Log Rank|||||3|-3|0.747
71873326|NCT03081052|143265013|OTHER||Hodges-Lehmann Location Shift|0.0||||0.638|TWO_SIDED|95.0|-1.0|1.0|||Log Rank|||||1|-1|0.638
71873327|NCT03081052|143265015|OTHER||mean ratio|1.19||||0.453|TWO_SIDED|95.0|0.76|1.87|||log-linear regression|||||1.87|0.76|0.453
71873328|NCT03081052|143265015|OTHER||mean ratio|0.94||||0.816|TWO_SIDED|95.0|0.57|1.56|||log-linear regression|||||1.56|0.57|0.816
71873329|NCT03081052|143265016|OTHER||mean ratio|1.03||||0.864|TWO_SIDED|95.0|0.75|1.41|||log-linear regression|||||1.41|0.75|0.864
71873330|NCT03081052|143265016|OTHER||mean ratio|0.97||||0.825|TWO_SIDED|95.0|0.73|1.28|||log-linear regression|||||1.28|0.73|0.825
71873331|NCT03081052|143265017|OTHER||Odds Ratio (OR)|1.43||||0.251|TWO_SIDED|95.0|0.78|2.61|||Chi-squared|||||2.61|0.78|0.251
71873332|NCT03081052|143265017|OTHER||Odds Ratio (OR)|1.2||||0.619|TWO_SIDED|95.0|0.58|2.5|||Chi-squared|||||2.5|0.58|0.619
71873333|NCT03081052|143265019|OTHER||Odds Ratio (OR)|2.13||||0.614|TWO_SIDED|95.0|0.19|23.82|||Fisher Exact|||||23.82|0.19|0.614
71873334|NCT03081052|143265019|OTHER||Odds Ratio (OR)|0.6||||0.5424|TWO_SIDED|95.0|0.17|2.12|||Fisher Exact|||||2.12|0.17|0.5424
71873335|NCT00719563|143265104|SUPERIORITY_OR_OTHER|||||||0.0737|||||||Wilcoxon Rank Sum|||||||0.0737
71873336|NCT00567268|143265123|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.004|||||||Fisher Exact|||"The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin."||||=0.004
71873337|NCT00567268|143265124|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Fisher Exact|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
71873338|NCT00567268|143265124|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.003|||||||Cochran-Armitage|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||=0.003
71873339|NCT00567268|143265125|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no difference between \<65 years and \>=65 years in the number of participants who responded to the treatment with gabapentin."||||<0.001
71873340|NCT00567268|143265126|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin."||||<0.001
71873341|NCT00567268|143265126|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was age. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories."||||<0.001
71873342|NCT00567268|143265127|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.008|||||||Chi-squared|||"The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||=0.008
71873343|NCT00567268|143265127|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.002|||||||Cochran-Armitage|||"The factor tested was severity of partial epileptic seizure. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe)."||||=0.002
71683373|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1179||||||P-value is for Functional Well-Being Cycle 4.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.1179
71873344|NCT00567268|143265128|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.018|||||||Chi-squared|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||=0.018
71873345|NCT00567268|143265129|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||<0.001
71873346|NCT00567268|143265129|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."||||<0.001
71873347|NCT00567268|143265130|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.025|||||||Cochran-Armitage|||"The factor tested was baseline creatinine clearance. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the baseline creatinine clearance."||||=0.025
71873348|NCT00567268|143265131|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.043|||||||Chi-squared|||"The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin."||||=0.043
71873349|NCT02952001|143265139|SUPERIORITY|||||||0.562||||||The a priori threshold for statistical significance was 0.050. No adjustments made or required for multiplicity.|Log-rank chi-square test|||The null hypothesis of no difference in the survival time distributions was tested.||||0.562
71873350|NCT04533451|143265144|SUPERIORITY|||||||0.0385|||||||Log Rank|||||||0.0385
71873351|NCT04533451|143265146|EQUIVALENCE|Relatively large sample size and groups are independent.||||||0.9829|||||||Chi-squared|||||||0.9829
71873352|NCT00820027|143265155|SUPERIORITY||Difference in Least Squares Mean|-0.49||||0.018|TWO_SIDED|95.0|-0.89|-0.08|||longitudinal data analysis (LDA)|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.08|-0.89|0.018
71873353|NCT00820027|143265155|SUPERIORITY||Difference in Least Squares Mean|-0.54||||0.009|TWO_SIDED|95.0|-0.95|-0.14|||LDA|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.||||-0.14|-0.95|0.009
71873354|NCT00820027|143265156|SUPERIORITY||Between-Treatment Ratio|0.69|||<|0.001|TWO_SIDED|95.0|0.56|0.85|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.85|0.56|<0.001
71873355|NCT00820027|143265156|SUPERIORITY||Between-Treatment Ratio|0.66|||<|0.001|TWO_SIDED|95.0|0.54|0.82|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio \<1 indicates a beneficial effect of Etoricoxib.|||0.82|0.54|<0.001
71873356|NCT00820027|143265157|OTHER||Difference in Percent|0.5||||0.506|TWO_SIDED|95.0|-3.3|2.5|||Miettinen & Nurminen|||||2.5|-3.3|0.506
71873357|NCT00820027|143265157|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
71873358|NCT00820027|143265157|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-3.8|1.7|||Miettinen & Nurminen|||||1.7|-3.8|>0.999
71873359|NCT00820027|143265157|OTHER||Difference in Percent|0.5||||0.316|TWO_SIDED|95.0|-1.3|2.5|||Miettinen & Nurminen|||||2.5|-1.3|0.316
71683374|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7412||||||P-value is for Functional Well-Being Cycle 5.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7412
71873360|NCT00820027|143265157|SUPERIORITY||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|1.7|||Miettinen & Nurminen|||||1.7|-1.7|>0.999
71873361|NCT00820027|143265157|OTHER||Difference in Percent|0.0|||>|0.999|TWO_SIDED|95.0|-1.7|3.8|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||3.8|-1.7|>0.999
71915370|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|0.2|STANDARD_ERROR_OF_MEAN|1.26||0.8556|TWO_SIDED|95.0|-2.2|2.7||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||2.7|-2.2|0.8556
71915371|NCT04315298|143351780|SUPERIORITY||Risk Difference (RD)|-1.3|STANDARD_ERROR_OF_MEAN|1.19||0.263|TWO_SIDED|95.0|-3.7|1.0||p-value using two-sample t-test|t-test, 2 sided|||Ventilator-free days up to Day 29||1.0|-3.7|0.2630
71915372|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.18||0.3662|TWO_SIDED|95.0|-0.2|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.5|-0.2|0.3662
71915373|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.16||0.082|TWO_SIDED|95.0|0.0|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.6|0.0|0.0820
71915374|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.6984|TWO_SIDED|95.0|-0.9|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.9|0.6984
71915375|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.32||0.9833|TWO_SIDED|95.0|-0.6|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.6|0.9833
71915376|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|0.9|STANDARD_ERROR_OF_MEAN|0.56||0.1436|TWO_SIDED|95.0|-0.3|2.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||2.0|-0.3|0.1436
71915377|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.49||0.419|TWO_SIDED|95.0|-0.6|1.4||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.4|-0.6|0.4190
71915378|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.47||0.652|TWO_SIDED|95.0|-0.7|1.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||1.2|-0.7|0.6520
71915379|NCT04315298|143351781|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.801|TWO_SIDED|95.0|-1.1|0.9||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.9|-1.1|0.8010
71915380|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3724|TWO_SIDED|95.0|-0.4|0.2||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.2|-0.4|0.3724
71915381|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.7034|TWO_SIDED|95.0|-0.2|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 8||0.3|-0.2|0.7034
71915382|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5841|TWO_SIDED|95.0|-0.4|0.7||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.7|-0.4|0.5841
71873362|NCT00820027|143265157|OTHER||Difference in Percent|-0.5||||0.309|TWO_SIDED|95.0|-2.5|1.2|||Miettinen & Nurminen|||||1.2|-2.5|0.309
71915383|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.6648|TWO_SIDED|95.0|-0.4|0.6||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 15||0.6|-0.4|0.6648
71915384|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4624|TWO_SIDED|95.0|-0.4|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.4|0.4624
71915385|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.32||0.2546|TWO_SIDED|95.0|-0.3|1.0||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 22||1.0|-0.3|0.2546
71915386|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.38||0.5312|TWO_SIDED|95.0|-1.0|0.5||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.5|-1.0|0.5312
71915387|NCT04315298|143351782|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.35||0.3039|TWO_SIDED|95.0|-1.1|0.3||p-value using two-sample t-test|t-test, 2 sided|||Hospitalized up to Day 29||0.3|-1.1|0.3039
71915388|NCT01183104|143351811|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was 0.3%.|LS mean difference|0.11||||0.087|TWO_SIDED|95.0|-0.02|0.24|||ANCOVA|||||0.24|-0.02|0.087
71683375|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3773||||||P-value is for Functional Well-Being Cycle 6.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.3773
71873363|NCT00820027|143265158|OTHER||Difference in Percent|-3.2||||0.054|TWO_SIDED|95.0|-9.2|0.1|||Miettinen & Nurminen|||||0.1|-9.2|0.054
71873364|NCT00820027|143265158|OTHER||Difference in Percent|-2.3||||0.209|TWO_SIDED|95.0|-8.4|1.2|||Miettinen & Nurminen|||||1.2|-8.4|0.209
71873365|NCT00820027|143265158|OTHER||Difference in Percent|-2.3||||0.227|TWO_SIDED|95.0|-8.4|1.3|||Miettinen & Nurminen|||||1.3|-8.4|0.227
71873366|NCT00820027|143265158|OTHER||Difference in Percent|-0.9||||0.415|TWO_SIDED|95.0|-3.7|1.6|||Miettinen & Nurminen|||||1.6|-3.7|0.415
71915389|NCT01183104|143351812|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
71915390|NCT01183104|143351813|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71915391|NCT01183104|143351814|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.030
71915392|NCT01183104|143351815|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71915393|NCT01183104|143351816|SUPERIORITY_OR_OTHER|||||||0.043|||||||ANCOVA|||||||0.043
71915394|NCT03267511|143351817|OTHER||Difference of Least Mean Square|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|||"The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.~The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives."|0.31|-0.19|0.6499
71683376|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7402||||||P-value is for Functional Well-Being Cycle 7.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.7402
71683377|NCT00586508|142885077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2671||||||P-value is for Functional Well-Being Cycle 8.|ANCOVA|P-value of treatment effect from an ANCOVA for change from baseline. Covariates include: treatment and baseline value.||||||0.2671
71683378|NCT01554176|142885108|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.7||||0.679|TWO_SIDED|95.0|-3.8|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).||2.5|-3.8|0.679
71683379|NCT01554176|142885109|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.82|TWO_SIDED|95.0|-3.2|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||2.5|-3.2|0.820
71683380|NCT01554176|142885110|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.3||||0.701|TWO_SIDED|95.0|-1.9|1.3||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items \[HAM-D17\] ≤20, \>20) and insomnia severity index (ISI ≤14, \>14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||1.3|-1.9|0.701
71683381|NCT01554176|142885111|SUPERIORITY_OR_OTHER||Estimated Odds Ratio|2.5||||0.0965|TWO_SIDED|95.0|0.8|7.3||Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.|Generalized Linear Mixed Effects Model|||Pairwise Comparison: Filorexant 10 mg vs. Placebo||7.3|0.8|0.0965
71683382|NCT01554176|142885112|SUPERIORITY_OR_OTHER||Difference in percentage incidence|15.6|||||TWO_SIDED|95.0|-0.9|31.4||||Between-group comparison of AE incident rate||Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.||31.4|-0.9|
71873367|NCT00820027|143265158|OTHER||Difference in Percent|-0.1||||0.965|TWO_SIDED|95.0|-3.0|2.8|||Miettinen & Nurminen|||||2.8|-3.0|0.965
71873368|NCT00820027|143265158|OTHER||Difference in Percent|2.3||||0.227|TWO_SIDED|95.0|-1.3|8.4|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||8.4|-1.3|0.227
71873369|NCT00820027|143265158|OTHER||Difference in Percent|0.8||||0.437|TWO_SIDED|95.0|-1.7|3.6|||Miettinen & Nurminen|||||3.6|-1.7|0.437
71873370|NCT00820027|143265159|OTHER||Difference in Percent|0.5||||0.806|TWO_SIDED|95.0|-5.3|4.5|||Miettinen & Nurminen|||||4.5|-5.3|0.806
71873371|NCT00820027|143265159|OTHER||Difference in Percent|-1.8||||0.278|TWO_SIDED|95.0|-7.4|1.4|||Miettinen & Nurminen|||||1.4|-7.4|0.278
71873372|NCT00820027|143265159|OTHER||Difference in Percent|0.1||||0.971|TWO_SIDED|95.0|-5.7|3.9|||Miettinen & Nurminen|||||3.9|-5.7|0.971
71873373|NCT00820027|143265159|OTHER||Difference in Percent|0.5||||0.786|TWO_SIDED|95.0|-3.2|4.2|||Miettinen & Nurminen|||||4.2|-3.2|0.786
71873374|NCT00820027|143265159|OTHER||Difference in Percent|-1.8||||0.184|TWO_SIDED|95.0|-5.2|1.0|||Miettinen & Nurminen|||||1.0|-5.2|0.184
71915395|NCT03267511|143351817|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|-0.33 to 0.18|||0.18|-0.33|0.5680
71915396|NCT03267511|143351818|OTHER||Difference of Least Square mean|0.06|STANDARD_ERROR_OF_MEAN|0.128||0.6499|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.31|-0.19|0.6499
71873375|NCT00820027|143265159|OTHER||Difference in Percent|-0.1||||0.971|TWO_SIDED|95.0|-3.9|5.7|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||5.7|-3.9|0.971
71873376|NCT00820027|143265159|OTHER||Difference in Percent|-2.3||||0.113|TWO_SIDED|95.0|-5.8|0.6|||Miettinen & Nurminen|||||0.6|-5.8|0.113
71873377|NCT00820027|143265160|OTHER||Difference in Percent|-5.3||||0.365|TWO_SIDED|95.0|-17.0|6.0|||Miettinen & Nurminen|||||6.0|-17.0|0.365
71915397|NCT03267511|143351819|OTHER||Difference of Least Square mean|-0.07|STANDARD_ERROR_OF_MEAN|0.128||0.568|TWO_SIDED|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.18|-0.33|0.5680
71873378|NCT00820027|143265160|OTHER||Difference in Percent|-7.2||||0.222||95.0|-18.8|4.2|||Miettinen & Nurminen|||||4.2|-18.8|0.222
71873379|NCT00820027|143265160|OTHER||Difference in Percent|-5.5||||0.349|TWO_SIDED|95.0|-17.2|5.9|||Miettinen & Nurminen|||||5.9|-17.2|0.349
71873380|NCT00820027|143265160|OTHER||Difference in Percent|0.2||||0.965|TWO_SIDED|95.0|-8.7|9.0|||Miettinen & Nurminen|||||9.0|-8.7|0.965
71873381|NCT00820027|143265160|OTHER||Difference in Percent|-1.6||||0.718|TWO_SIDED|95.0|-10.5|7.3|||Miettinen & Nurminen|||||7.3|-10.5|0.718
71873382|NCT00820027|143265160|OTHER||Difference in Percent|5.5||||0.349|TWO_SIDED|95.0|-5.9|17.2|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg||17.2|-5.9|0.349
71873383|NCT00820027|143265160|OTHER||Difference in Percent|1.8||||0.684|TWO_SIDED|95.0|-7.0|10.6|||Miettinen & Nurminen|||||10.6|-7.0|0.684
71873384|NCT00820027|143265161|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Difference in Least Squares Mean|-0.04|||||TWO_SIDED|95.0|-0.36|0.27||||||||0.27|-0.36|
71873385|NCT00820027|143265161|NON_INFERIORITY|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.42|0.22||||||||0.22|-0.42|
71873386|NCT00820027|143265162|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.05|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
71873387|NCT00820027|143265162|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.01|||||TWO_SIDED|95.0|0.85|1.18|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.18|0.85|
71915398|NCT03887052|143351843|NON_INFERIORITY|The primary endpoint was performed as a one-sided test with a 0.025 significance level of the null hypothesis (H0) that the WCD false positive shock alarm rate per patient-day for the study device was equal to or greater than the comparator rate (0.29). A random-effects Poisson regression model was fit with the number of false-positive shock alarms for each patient as the outcome, the logarithm of days of wear as an offset, and random site effect.|||||<|0.001||||||"Hypotheses:~H0: p1 ≥ 0.29 H1: p1 \< 0.29~where p1 = A-WCD False Positive Alarm Rate"|One-sided non-inferiority|Poisson Regression Analysis||The analysis was based on the cohort of 130 patients with three false-positive shock alarms occurring over a total of 3501 patient-days (500 weeks), or 0.0060 false-positive shock alarms per patient-week. The Poisson distribution was used to model the results and calculate the false-positive shock alarm rate.||||<0.001
71915399|NCT02128958|143351854|OTHER|||||||0.536|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Overall Survival will be performed using the log rank test as the primary analysis.||||0.536
71915400|NCT02128958|143351855|OTHER|||||||0.371|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) of Time to Progression will be performed using the log rank test as the primary analysis.||||.371
71915401|NCT02128958|143351856|OTHER|||||||0.521|||||||Log Rank|||The between-treatment comparison (CF102 vs Placebo) will be performed on Time to Progression Free Survival using the logrank test.||||0.521
71915402|NCT02128958|143351859|OTHER|||||||0.988|||||||ANCOVA|||Between-treatment comparisons of ALT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.988
71915403|NCT02128958|143351859|OTHER|||||||0.989|||||||ANCOVA|||Between-treatment comparisons of AST will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.989
71915404|NCT02128958|143351859|OTHER|||||||0.717|||||||ANCOVA|||Between-treatment comparisons of Albumin will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.717
71915405|NCT02128958|143351859|OTHER|||||||0.891|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (direct) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.891
71915406|NCT02128958|143351859|OTHER|||||||0.275|||||||ANCOVA|||Between-treatment comparisons of Bilirubin (Total) will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.275
71915407|NCT02128958|143351859|OTHER|||||||0.549|||||||ANCOVA|||Between-treatment comparisons of PT will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.549
71915408|NCT02128958|143351859|OTHER|||||||0.479|||||||ANCOVA|||Between-treatment comparisons of INR will be performed at Cycle 11 Day 15 using ANCOVA with CFB as the dependent variable and the Baseline value of the variable as the covariate.||||0.479
71915409|NCT00981292|143351867|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||A Bonferroni adjustment was made for multiplicity.|ANOVA|||This data was analysed by two-way repeated measures ANOVA (task \[epoch\] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.||||<0.05
71915410|NCT00981292|143351868|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.||||>0.05
71915411|NCT00981292|143351869|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||Mood data was analysed via student t-test.||||>0.05
71915412|NCT00262639|143351916|SUPERIORITY|||||||0.03|||||||Regression, Logistic|||||||0.03
71915413|NCT00262639|143351917|SUPERIORITY|||||||0.0006||||||This p value is for the interaction of AW status by medication group.|ANOVA|||The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.||||0.0006
71915414|NCT01849562|143351921|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|50.0|||||TWO_SIDED|95.0|1.8|82.7||||||Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||82.7|1.8|
71915415|NCT01849562|143351921|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|70.0|||||TWO_SIDED|95.0|24.2|93.6||||||Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.||93.6|24.2|
71915416|NCT02182999|143351932|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.596|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).||||0.596
71915417|NCT02182999|143351933|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.353|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.353
71915418|NCT01791465|143351955|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71915419|NCT01791465|143351956|SUPERIORITY_OR_OTHER|||||||0.34||||||Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison|Wilcoxon (Mann-Whitney)|no adjustments||The null hypothesis was that there would be no difference between baseline and 16 week IL-6||||0.34
71915420|NCT01791465|143351957|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71683383|NCT01554176|142885113|SUPERIORITY_OR_OTHER||Difference in percentage incidence|0.0|||||TWO_SIDED|95.0|-7.0|7.0||||Between-group comparison of incidence rate of drug discontinuation due to AE||Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).||7|-7|
71873388|NCT00820027|143265162|OTHER|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.04|||||TWO_SIDED|95.0|0.89|1.23|||||A ratio \<1 indicates a beneficial effect of Etoricoxib.|||1.23|0.89|
71873389|NCT02982187|143265164|SUPERIORITY||Odds Ratio (OR)|29.114|||<|0.001|TWO_SIDED|95.0|11.047||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1: DISKUS + HandiHaler vs ELLIPTA|||11.047|<0.001
71873390|NCT02982187|143265164|SUPERIORITY||Odds Ratio (OR)|27.744|||<|0.001|TWO_SIDED|95.0|10.512||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||10.512|<0.001
71873391|NCT02982187|143265165|SUPERIORITY||Odds Ratio (OR)|4.248||||0.029|TWO_SIDED|95.0|1.416||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.416|0.029
71873392|NCT02982187|143265165|SUPERIORITY||Odds Ratio (OR)|3.855||||0.026|TWO_SIDED|95.0|1.394||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||1.394|0.026
71915421|NCT01791465|143351958|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71915422|NCT01791465|143351959|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71915423|NCT01791465|143351960|SUPERIORITY_OR_OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71915424|NCT01791465|143351961|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71915425|NCT01791465|143351962|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71915426|NCT01791465|143351963|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71915427|NCT01791465|143351964|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71915428|NCT01791465|143351965|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71915429|NCT01791465|143351966|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71683384|NCT01085136|142885116|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.003|TWO_SIDED|95.0|0.44|0.85||P-value is calculated from two-sided stratified log-rank test|stratified log-rank test|||Hazard ratio is calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||0.85|0.44|0.0030
71915430|NCT01791465|143351967|SUPERIORITY_OR_OTHER|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||||||0.69
71915431|NCT01791465|143351968|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.50
71915432|NCT01791465|143351969|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71915433|NCT01791465|143351970|SUPERIORITY_OR_OTHER|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||||||0.89
71915434|NCT01791465|143351971|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71915435|NCT01791465|143351972|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71915436|NCT01791465|143351973|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71915437|NCT01791465|143351974|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71915438|NCT01791465|143351975|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||||||0.046
71915439|NCT02736929|143351985|SUPERIORITY||Mean Difference (Final Values)|9.8||||0.12|TWO_SIDED|95.0|-2.7|22.3|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up||22.3|-2.7|0.12
71915440|NCT02736929|143351986|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.024|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.5|0.1|0.024
71915441|NCT02736929|143351987|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.027|TWO_SIDED|95.0|0.0|0.6|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.6|0.0|0.027
71915442|NCT02736929|143351988|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.024|TWO_SIDED|95.0|0.5|7.1|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||7.1|0.5|0.024
71915443|NCT02736929|143351989|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.19|TWO_SIDED|95.0|-9.8|2.0|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||2.0|-9.8|0.19
71915444|NCT02736929|143351990|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.31|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||0.4|-1.3|0.31
71683385|NCT01085136|142885118|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.7905|TWO_SIDED|95.0|0.76|1.44|||Stratified log-rank test.|P-value is calculated from two-sided stratified log-rank test.||Hazard ratio was calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (\<6 months vs \>=6 months).||1.44|0.76|0.7905
71683386|NCT01085136|142885120|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.98||||0.0065|TWO_SIDED|95.0|1.357|6.543|||Regression, Logistic|||Odds ratio, 95% Confidence Interval (CI) and p-value (two-sided) from logistic regression stratified for maximum treatment duration of prior erlotinib or gefitinib (\>=6 months vs \<6 months) and gender.||6.543|1.357|0.0065
71683387|NCT02301039|142885131|SUPERIORITY|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.|Binomial estimate of response rate of PR|17.5|||||TWO_SIDED|95.0|7.3|32.8|||||Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||32.8|7.3|
71683388|NCT02301039|142885131|SUPERIORITY||Binomial estimate of response rate of PR|5.0|||||TWO_SIDED|95.0|1.0|16.9|||||Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||16.9|1.0|
71683389|NCT02301039|142885131|SUPERIORITY||Binomial estimate of response rate of PR|13.0|||||TWO_SIDED|95.0|5.5|25.3|||||Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients|An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.||25.3|5.5|
71683390|NCT00316914|142885158|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||A priori threshold for the p-value is 0.05 and there was no adjustment for multiple comparisons.|Chi-squared|||Comparison in Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event between Arms||||0.038
71683391|NCT00316914|142885159|SUPERIORITY_OR_OTHER|||||||0.0503||95.0|||||Log Rank|||Comparison of time to Onset of Grade 2+ Chronic Neurotoxicity between Arms||||0.0503
71683392|NCT00316914|142885160|SUPERIORITY_OR_OTHER|||||||0.4048||95.0|||||Log Rank|||Comparison of Time to Onset of Grade 3+ Chronic Neurotoxicity between Arms||||0.4048
71683393|NCT00316914|142885161|SUPERIORITY_OR_OTHER|||||||0.6556||95.0|||||Log Rank|||Comparison of Average Duration of Chronic Neuropathic Toxicity between Arms||||0.6556
71873393|NCT02982187|143265166|SUPERIORITY||Odds Ratio (OR)|2.0||||0.4|TWO_SIDED|95.0|0.459||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||0.459|0.400
71873394|NCT02982187|143265166|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
71915445|NCT02736929|143351991|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.5|-1.8|0.86
71683394|NCT00316914|142885162|SUPERIORITY_OR_OTHER|||||||0.3238||95.0|||||Chi-squared|||Comparison of Percentage of patients discontinuing therapy for chronic neurotoxicity between Arms||||0.3238
71683395|NCT00316914|142885165|SUPERIORITY_OR_OTHER|||||||0.7498||95.0|||||Chi-squared|||Comparison of Percentage of Patients With Acute Neuropathic Adverse Event between Arms||||0.7498
71683396|NCT00316914|142885168|SUPERIORITY_OR_OTHER|||||||0.234||95.0|||||Kruskal-Wallis|||Comparison of Fatigue NOW between two arms||||0.2340
71683397|NCT00316914|142885168|SUPERIORITY_OR_OTHER|||||||0.201||95.0|||||Kruskal-Wallis|||Comparison of Fatigue USUAL between two arms||||0.2010
71683398|NCT00316914|142885168|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Comparison of Fatigue WORST between two arms||||0.9364
71915446|NCT02736929|143351992|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.77|TWO_SIDED|95.0|-1.7|1.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 6-week follow-up.||1.2|-1.7|0.77
71915447|NCT03342404|143351997|SUPERIORITY||Difference in proportions|77.1|||||TWO_SIDED|95.0|63.4|87.0|||||The difference in proportions (luspatercept - placebo) and 95% CI were estimated from the exact unconditional test|||87.0|63.4|
71683399|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.9364||95.0|||||Kruskal-Wallis|||Fatigue WORST||||0.9364
71683400|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.6275||95.0|||||Kruskal-Wallis|||Walking||||0.6275
71915448|NCT03342404|143351997|SUPERIORITY||Risk Difference (RD)|77.1|||||TWO_SIDED|95.0|68.7|85.5|||||The common risk difference (luspatercept - placebo) and 95% CI were estimated from the CMH test stratified by baseline Hb category and baseline NTDT-PRO T/W domain score category|||85.5|68.7|
71915449|NCT03342404|143351998|SUPERIORITY||Mean Difference (Net)|-0.48||||0.0924|TWO_SIDED|95.0|-1.03|0.08|||ANCOVA|||||0.08|-1.03|0.0924
71915450|NCT03342404|143351999|SUPERIORITY||Mean Difference (Net)|1.42|||<|0.0001|TWO_SIDED|95.0|1.16|1.67|||ANCOVA|||||1.67|1.16|< 0.0001
71915451|NCT03342404|143352000|SUPERIORITY||Mean Difference (Net)|68.8|||<|0.0001|TWO_SIDED|95.0|54.3|80.4|||Cochran-Mantel-Haenszel|||||80.4|54.3|< 0.0001
71915452|NCT03342404|143352001|SUPERIORITY||Mean Difference (Net)|1.39||||0.2641|TWO_SIDED|95.0|-1.06|3.83|||ANCOVA|||||3.83|-1.06|0.2641
71915453|NCT03342404|143352002|SUPERIORITY||Mean Difference (Net)|-0.49||||0.0721|TWO_SIDED|95.0|-1.02|0.04|||ANCOVA|||||0.04|-1.02|0.0721
71915454|NCT03342404|143352003|SUPERIORITY||Mean Difference (Net)|1.49|||<|0.0001|TWO_SIDED|95.0|1.2|1.79|||ANCOVA|||||1.79|1.20|< 0.0001
71683401|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.6988||95.0|||||Kruskal-Wallis|||Buttoning Shirt or Tying Laces||||0.6988
71683402|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.5124||95.0|||||Kruskal-Wallis|||Diarrhea||||0.5124
71873395|NCT02982187|143265167|SUPERIORITY||Odds Ratio (OR)|24.539|||<|0.001|TWO_SIDED|95.0|9.268||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||9.268|<0.001
71873396|NCT02982187|143265167|SUPERIORITY||Odds Ratio (OR)|17.974|||<|0.001|TWO_SIDED|95.0|7.239||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||7.239|<0.001
71873397|NCT02982187|143265168|SUPERIORITY||Odds Ratio (OR)|3.237||||0.067|TWO_SIDED|95.0|1.124||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|||1.124|0.067
71873398|NCT02982187|143265168|SUPERIORITY||Odds Ratio (OR)|6.357||||0.003|TWO_SIDED|95.0|2.219||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||2.219|0.003
71873399|NCT02982187|143265169|SUPERIORITY||||||||||||||stratified exact logistic model|||Sub study 1: DISKUS + HandiHaler vs ELLIPTA|These statistics were only presented when the model successfully converged. A stratified exact logistic model was used with participant included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|||
71873400|NCT02982187|143265169|SUPERIORITY||Odds Ratio (OR)|1.732||||0.5|TWO_SIDED|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|||0.397|0.500
71873401|NCT02982187|143265170|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 1:DISKUS + HandiHaler vs ELLIPTA||||<0.001
71873402|NCT02982187|143265170|SUPERIORITY||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA||||<0.001
71873403|NCT02982187|143265174|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71873404|NCT02982187|143265174|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71873405|NCT02982187|143265175|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71873406|NCT02982187|143265175|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71683403|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.3103||95.0|||||Kruskal-Wallis|||Constipation||||0.3103
71873407|NCT02604433|143265176|SUPERIORITY||Odds Ratio (OR)|5.62|||<|0.0001|TWO_SIDED|95.0|2.17|14.53||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||14.53|2.17|<0.0001
71873408|NCT02604433|143265176|SUPERIORITY||Difference in Percentages|16.5|||||TWO_SIDED|95.0|10.0|23.1|||||Luspatercept - Placebo|||23.1|10.0|
71683404|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.8601||95.0|||||Kruskal-Wallis|||Abdominal Cramping||||0.8601
71873409|NCT02604433|143265176|SUPERIORITY||Common Risk Difference|16.5||||||95.0|9.9|23.1|||||Luspatercept - Placebo|||23.1|9.9|
71873410|NCT02604433|143265177|SUPERIORITY||Odds Ratio (OR)|6.44|||<|0.0001|TWO_SIDED|95.0|2.27|18.26||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% CIs, and p-value were estimated from the CMH test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate for outcomes 2-4, the testing procedure was implemented strictly in order: the test for this outcome was only conducted when there was evidence showing that erythroid response was achieved in the luspatercept group from Week 13 to Week 24 (primary endpoint).||18.26|2.27|<0.0001
71873411|NCT02604433|143265178|SUPERIORITY||Odds Ratio (OR)|4.24||||0.0402|TWO_SIDED|95.0|0.96|18.79||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.||18.79|0.96|0.0402
71915455|NCT03342404|143352004|SUPERIORITY||Mean Difference (Net)|2.19||||0.0959|TWO_SIDED|95.0|-0.39|4.78|||ANCOVA|||||4.78|-0.39|0.0959
71915456|NCT03342404|143352005|SUPERIORITY||Mean Difference (Net)|-0.79||||0.051|TWO_SIDED|95.0|-1.58|0.0|||ANCOVA|||||0.00|-1.58|0.0510
71683405|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.2439||95.0|||||Kruskal-Wallis|||Bowel Problems with Normal Activity||||0.2439
71683406|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.9283||95.0|||||Kruskal-Wallis|||Shortness of Breath (Week 2 - Baseline)||||0.9283
71683407|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.4715||95.0|||||Kruskal-Wallis|||Swallowing (Week 2 - Baseline)||||0.4715
71683408|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.5105||95.0|||||Kruskal-Wallis|||Numbness in Fingers, Toes (Week 2 - Baseline)||||0.5105
71683409|NCT00316914|142885169|SUPERIORITY_OR_OTHER|||||||0.2181||95.0|||||Kruskal-Wallis|||Tingling in Fingers, Toes (Week 2 - Baseline)||||0.2181
71683410|NCT04105010|142885170|SUPERIORITY||||||<|0.0001|||||||Binomial test against a null|||||||<0.0001
71873412|NCT02604433|143265179|SUPERIORITY||Odds Ratio (OR)|11.92||||0.0017|TWO_SIDED|95.0|1.65|86.29||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and achievement of objective in the luspatercept group in outcomes 2+3.||86.29|1.65|0.0017
71683411|NCT02380859|142885191|SUPERIORITY|||||||0.005|||||||ANOVA|||Group (real, sham) x Time (pre, 1d post) x Stepping Direction (forward, backward) ANOVA||||0.005
71683412|NCT02284568|142885205|SUPERIORITY||Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.1293||0.903|TWO_SIDED|95.0|-0.239|0.2705||significance at 0.05.|Repeated Measures ANCOVA|||The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||0.2705|-0.2390|0.903
71683413|NCT02284568|142885207|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.426|TWO_SIDED|95.0|0.48|1.37||significance at 0.05. p-value was from a log-rank test, and estimate and confidence limits were from a Cox model with treatment group as fixed effect, due to the violation of the proportionality assumption.|Log Rank||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.37|0.48|0.426
71683414|NCT02284568|142885208|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.867|TWO_SIDED|95.0|0.68|1.59||significance at 0.05.|Regression, Cox||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or \>4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.||1.59|0.68|0.867
71683415|NCT02284568|142885209|SUPERIORITY||Mean Difference (Final Values)|-0.325|STANDARD_ERROR_OF_MEAN|0.2679||0.248|TWO_SIDED|95.0|-0.85|0.2||significance at 0.05. The p-value for ranked change from baseline values was from a repeated measures analysis of covariance with trt group, week, treatment group by week interaction, rank of T25FW score at baseline, and country as fixed effects.|Repeated Measures ANCOVA||Laquinimod 0.6 mg vs. placebo treatment effect|placebo n=121 Laquinimod 0.6 mg n=108 The estimate of parameter, standard error, and 95% confidence intervals for change from baseline was from a Mann-Whitney-Wilcoxon Test using Hodges-Lehmann estimates.||0.2000|-0.8500|0.248
71873413|NCT02604433|143265180|SUPERIORITY||LSM Difference|-1.34|||<|0.0001|TWO_SIDED|95.0|-1.76|-0.93||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean||-0.93|-1.76|<0.0001
71873414|NCT02604433|143265181|SUPERIORITY||LS Mean of Difference|0.2||||0.7598|TWO_SIDED|95.0|-1.1|1.51||Significance level of 0.050 for 2-sided tests.|ANCOVA||luspatercept - placebo|Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LS = least square||1.51|-1.10|0.7598
71873415|NCT02604433|143265182|SUPERIORITY||LS Mean of Difference|-68.0||||0.2552|TWO_SIDED|95.0|-185.8|49.7||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferasirox: Change from baseline at Week 48 LS = least squares||49.7|-185.8|0.2552
71873416|NCT02604433|143265182|SUPERIORITY||LS Mean of Difference|-76.4||||0.7746|TWO_SIDED|95.0|-612.9|460.1||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferiprone: Change from baseline at Week 48 LS = least squares||460.1|-612.9|0.7746
71873417|NCT02604433|143265182|SUPERIORITY||LS Mean of Difference|-147.3||||0.5186|TWO_SIDED|95.0|-673.1|378.5||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LS = least squares||378.5|-673.1|0.5186
71873418|NCT02604433|143265183|SUPERIORITY||LS Mean of Difference|-342.59|||<|0.0001|TWO_SIDED|95.0|-498.3|-186.87||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least squares||-186.87|-498.30|<0.0001
71873419|NCT02604433|143265184|SUPERIORITY||LS Mean of Difference|0.0||||0.9201|TWO_SIDED|95.0|-0.01|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Total Hip Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.01|0.9201
71873420|NCT02604433|143265184|SUPERIORITY||LS Mean of Difference|-0.01||||0.462|TWO_SIDED|95.0|-0.02|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Lumbar Spine Bone Mineral Density: Change from baseline at Week 48 LS = least squares||0.01|-0.02|0.4620
71873421|NCT02604433|143265185|SUPERIORITY||LS Mean of Difference|-2.22||||0.0543|TWO_SIDED|95.0|-4.48|0.04||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2\* as covariates.|luspatercept - placebo|Change from baseline at Week 48 LS = least square||0.04|-4.48|0.0543
71873422|NCT02604433|143265186|SUPERIORITY|||||||0.666||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Health Domain Score - Change from Baseline at Week 24||||0.666
71873423|NCT02604433|143265186|SUPERIORITY|||||||0.384||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Total Score - Change from Baseline at Week 24||||0.384
71873424|NCT02604433|143265187|SUPERIORITY|||||||0.918||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Physical Functioning Domain - Change from Baseline at Week 24||||0.918
71915457|NCT03342404|143352006|SUPERIORITY||Mean Difference (Net)|-1.07||||0.0047|TWO_SIDED|95.0|-1.8|-0.33|||ANCOVA|||||-0.33|-1.80|0.0047
71915458|NCT03342404|143352007|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1359|TWO_SIDED|95.0|0.8|4.0|||Cochran-Mantel-Haenszel|||||4.0|0.8|0.1359
71915459|NCT03342404|143352008|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0657|TWO_SIDED|95.0|0.9|5.4|||Cochran-Mantel-Haenszel|||||5.4|0.9|0.0657
71915460|NCT03342404|143352009|SUPERIORITY||Mean Difference (Net)|1.39||||0.0847|TWO_SIDED|95.0|-0.19|2.96|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 24||2.96|-0.19|0.0847
71915461|NCT03342404|143352009|SUPERIORITY||Mean Difference (Net)|1.75||||0.0712|TWO_SIDED|95.0|-0.15|3.65|||Mixed Models Analysis|||Mean change from baseline in SF-36 PCS to Week 48||3.65|-0.15|0.0712
71915462|NCT03342404|143352009|SUPERIORITY||Mean Difference (Net)|1.54||||0.1633|TWO_SIDED|95.0|-0.63|3.72|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 24||3.72|-0.63|0.1633
71915463|NCT03342404|143352009|SUPERIORITY||Mean Difference (Net)|2.7||||0.0469|TWO_SIDED|95.0|0.04|5.36|||Mixed Models Analysis|||Mean change from baseline in SF-36 MCS to Week 48||5.36|0.04|0.0469
71915464|NCT03342404|143352010|SUPERIORITY||Mean Difference (Net)|-4.2||||0.4787|TWO_SIDED|95.0|-21.4|13.0|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 24||13.0|-21.4|0.4787
71915465|NCT03342404|143352010|SUPERIORITY||Mean Difference (Net)|-14.6||||0.0827|TWO_SIDED|95.0|-31.5|2.4|||Cochran-Mantel-Haenszel|||Percentage of participants with improvement of iron overload (LIC/ICT responders) at Week 48||2.4|-31.5|0.0827
71915466|NCT03342404|143352011|SUPERIORITY||Mean Difference (Net)|27.14||||0.5949|TWO_SIDED|95.0|-46.77|101.06|||ANCOVA|||Mean change from baseline in serum ferritin at Week 24||101.06|-46.77|0.5949
71915467|NCT03342404|143352011|SUPERIORITY||Mean Difference (Net)|13.46||||0.3454|TWO_SIDED|95.0|-61.01|87.93|||ANCOVA|||Mean change from baseline in serum ferritin at Week 48||87.93|-61.01|0.3454
71915468|NCT03342404|143352012|SUPERIORITY||Mean Difference (Net)|-0.09||||0.6628|TWO_SIDED|95.0|-0.47|0.3|||ANCOVA|||Mean change from baseline in LIC at Week 24||0.30|-0.47|0.6628
71915469|NCT03342404|143352012|SUPERIORITY||Mean Difference (Net)|0.66||||0.0859|TWO_SIDED|95.0|-0.09|1.42|||ANCOVA|||Mean change from baseline in LIC at Week 48||1.42|-0.09|0.0859
71915470|NCT03342404|143352013|SUPERIORITY||Mean Difference (Net)|22.2||||0.0013|TWO_SIDED|95.0|5.0|38.6|||Cochran-Mantel-Haenszel|||Percentage of participants who were transfusion free over 24 weeks||38.6|5.0|0.0013
71915471|NCT03342404|143352014|SUPERIORITY||Mean Difference (Net)|37.4|||<|0.0001|TWO_SIDED|95.0|20.9|53.0|||Cochran-Mantel-Haenszel|||Percentage of Participants Who are Transfusion-Free Over 48 Weeks||53.0|20.9|< 0.0001
71915472|NCT03342404|143352016|SUPERIORITY||Mean Difference (Net)|16.15||||0.1466|TWO_SIDED|95.0|-5.73|38.04|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 24||38.04|-5.73|0.1466
71915473|NCT03342404|143352016|SUPERIORITY||Mean Difference (Net)|12.44||||0.2011|TWO_SIDED|95.0|-6.72|31.59|||ANCOVA|||Mean change from baseline in 6MWT distance at Week 48||31.59|-6.72|0.2011
71915474|NCT03342404|143352017|SUPERIORITY||Mean Difference (Net)|52.1|||<|0.0001|TWO_SIDED|95.0|36.2|66.2|||Cochran-Mantel-Haenszel|||Percentage of Participants with an Increase From Baseline ≥1.5 g/dL in Mean Hemoglobin Values in the Absence of Transfusion||66.2|36.2|< 0.0001
71915475|NCT03342404|143352018|SUPERIORITY||Mean Difference (Net)|1.7||||0.1989|TWO_SIDED|95.0|0.8|3.7|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 13 to Week 24||3.7|0.8|0.1989
71915476|NCT03342404|143352018|SUPERIORITY||Mean Difference (Net)|2.1||||0.0733|TWO_SIDED|95.0|0.9|5.0|||Cochran-Mantel-Haenszel|||Percentage of Participants With a Decrease From Baseline ≥ RD (= 1) in the Non-Transfusion Dependent β-thalassemia-Patient Reported Outcome (NTDT-PRO) Tiredness and Weakness (T/W) Domain Score Week 37 to Week 48||5.0|0.9|0.0733
71915477|NCT01690988|143352028|OTHER|Test of independence|Difference in Percentages|0.36|STANDARD_ERROR_OF_MEAN|3.301||0.912|TWO_SIDED|95.0|-6.07|7.38|||Chi-squared||Difference in delirium incidence between placebo control and combined ketamine groups.|The primary analysis was a comparison between the placebo control group and the combined ketamine groups||7.38|-6.07|0.912
71915478|NCT01690988|143352029|SUPERIORITY|||||||0.964|||||||ANOVA|one-way||We compared the combined average pain level (pain level at rest, taking a deep breath, and/or when moving) over the entire day (AM and PM).||||0.964
71915479|NCT01690988|143352030|SUPERIORITY|||||||0.476|||||||ANOVA|||"All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~\* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"||||0.476
71915480|NCT01690988|143352031|SUPERIORITY||frequency-test|0.572||||0.572|TWO_SIDED||||||Chi-squared|||"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM \& PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3"||||0.572
71915481|NCT01690988|143352033|SUPERIORITY|||||||0.01|||||||Chi-squared|||Frequency of patients reporting hallucinations using the DSAQ instrument.||||0.01
71915482|NCT01690988|143352034|SUPERIORITY|||||||0.03||||||"Patients where asked whether Following their surgery they had bad dreams or nightmares the response choices: Yes/No question The incidence of hallucination and nightmares were assessed separately and compared across the three study group."|Chi-squared|||||||0.03
71915483|NCT00638274|143352035|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
71915484|NCT00638274|143352035|OTHER||||||>|0.05|||||||Chi-squared|||||||>.05
71915485|NCT01634100|143352037|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|135.2|STANDARD_DEVIATION|7.3|||TWO_SIDED|90.0|129.58|141.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||141.06|129.58|
71683416|NCT02284568|142885210|SUPERIORITY||Risk Ratio (RR)|0.4|STANDARD_ERROR_OF_MEAN|0.11||0.001|TWO_SIDED|95.0|0.26|0.69||significance at 0.05|negative binomial regression model||Laquinimod 0.6 mg vs. placebo risk ratio|This analysis was performed using baseline adjusted negative binomial regression model (SAS® PROC GENMOD) in which 1 contrast for comparing laquinimod 0.6 mg to placebo was constructed. In addition to the treatment group, the natural logarithm of T2 lesion volume at baseline, age at baseline and country/geographical region (CGR) were used as covariates.||0.69|0.26|0.001
71683417|NCT03114657|142885217|SUPERIORITY||Least Squares Mean Difference|1.3|STANDARD_ERROR_OF_MEAN|0.633|||TWO_SIDED|95.0|0.0|2.6||||||||2.60|0.00|
71683418|NCT03114657|142885218|SUPERIORITY||Least Squares Mean Difference|1.74|STANDARD_ERROR_OF_MEAN|2.028|||TWO_SIDED|95.0|-2.4|5.89||||||||5.89|-2.40|
71683419|NCT03114657|142885219|SUPERIORITY||Least Squares Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|2.124|||TWO_SIDED|95.0|-4.03|4.68||||||||4.68|-4.03|
71683420|NCT03114657|142885220|SUPERIORITY||Least Squares Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.141|||TWO_SIDED|95.0|-0.2|0.39||||||||0.39|-0.20|
71683421|NCT03114657|142885221|SUPERIORITY||Least Squares Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.985|||TWO_SIDED|95.0|-2.42|1.6||||||||1.60|-2.42|
71683422|NCT03114657|142885222|SUPERIORITY||Least Squares Mean Difference|-2.52|STANDARD_ERROR_OF_MEAN|3.052|||TWO_SIDED|95.0|-8.74|3.7||||||||3.70|-8.74|
71683423|NCT03114657|142885223|SUPERIORITY||Least Squares Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|2.501|||TWO_SIDED|95.0|-6.29|3.92||||||||3.92|-6.29|
71683424|NCT03114657|142885224|SUPERIORITY||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|1.42|||TWO_SIDED|95.0|-2.25|3.51||||||||3.51|-2.25|
71873425|NCT02604433|143265187|SUPERIORITY|||||||0.857||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||General Health Domain - Change from Baseline at Week 24||||0.857
71873426|NCT02604433|143265187|SUPERIORITY|||||||0.839||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||PCS - Change from Baseline at Week 24||||0.839
71683425|NCT03114657|142885226|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.502|||TWO_SIDED|95.0|-1.75|0.23||||||||0.23|-1.75|
71683426|NCT03114657|142885227|SUPERIORITY||Least Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|1.383|||TWO_SIDED|95.0|-3.3|2.39||||||||2.39|-3.30|
71683427|NCT03114657|142885228|SUPERIORITY||Least Squares Mean Difference|6.55|STANDARD_ERROR_OF_MEAN|5.527|||TWO_SIDED|95.0|-4.35|17.44||||||||17.44|-4.35|
71683428|NCT03114657|142885229|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|5.831|||TWO_SIDED|95.0|-12.31|11.71||||||||11.71|-12.31|
71683429|NCT03114657|142885230|SUPERIORITY||Least Squares Mean Difference|-3.38|STANDARD_ERROR_OF_MEAN|3.94|||TWO_SIDED|95.0|-11.5|4.73||||||||4.73|-11.50|
71683430|NCT03114657|142885236|SUPERIORITY||Least Squares Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.622|||TWO_SIDED|95.0|-2.01|0.89||||||||0.89|-2.01|
71683431|NCT03114657|142885237|SUPERIORITY||Least Squares Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|1.668|||TWO_SIDED|95.0|-1.7|4.9||||||||4.90|-1.70|
71683432|NCT03114657|142885238|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.373|||TWO_SIDED|95.0|-1.13|0.41||||||||0.41|-1.13|
71683433|NCT01546038|142885244|OTHER||Hazard Ratio (HR)|0.569||||0.002|TWO_SIDED|80.0|0.441|0.734||1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).|Log Rank||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||0.734|0.441|0.0020
71683434|NCT01546038|142885248|OTHER||Odds Ratio (OR)|4.2755||||0.0112|TWO_SIDED|80.0|1.3057|13.9994|||Cochran-Mantel-Haenszel||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.|||13.9994|1.3057|0.0112
71873427|NCT02604433|143265190|SUPERIORITY||Odds Ratio (OR)|7.6||||0.0015|TWO_SIDED|95.0|1.8|32.9||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.||32.9|1.8|0.0015
71683435|NCT00987402|142885327|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||generalized estimating equation|||Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.||||<0.05
71683436|NCT03878875|142885337|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|116.044|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = -2.153.||||||< 0.0005
71873428|NCT02604433|143265193|SUPERIORITY||Mean Difference (Final Values)|-67.27||||0.0195|TWO_SIDED|95.0|-123.63|-10.91||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 33% Transfusion Burden Reduction||-10.91|-123.63|0.0195
71873429|NCT02604433|143265193|SUPERIORITY||Mean Difference (Final Values)|28.24||||0.7473|TWO_SIDED|95.0|-144.87|201.34||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|≥ 50% Transfusion Burden Reduction||201.34|-144.87|0.7473
71873430|NCT01326533|143265242|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||<0.01
71683437|NCT03878875|142885338|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|12.839|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient = 1.602.||||||< 0.0005
71683438|NCT03878875|142885339|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|8.391|||<|0.0005|TWO_SIDED||||||Regression, Linear|Group coefficient was 1.059.||||||< 0.0005
71683439|NCT03878875|142885340|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|6.416|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was 0.635.||||||< 0.001
71683440|NCT03878875|142885341|SUPERIORITY|Multiple linear regressions analysed the effect of conditioning (group) on each outcome at the second time point - session 2 (after noise exposure), controlling for session 1 outcome (before noise exposure), event exposure, age, and gender. It was hypothesised those with high recent noise exposure, Group 1 (noise unit \> 0.323), would experience less temporary hearing damage than irregular attendees, Group 0.|F(5, 26)|5.805|||<|0.001|TWO_SIDED||||||Regression, Linear|Group coefficient was -0.383.||||||< 0.001
71683441|NCT03878875|142885342|SUPERIORITY|A binary logistic regression was employed to assess the effect of conditioning on tinnitus change (i.e. increasing or not) at session 2, adjusting for tinnitus reported at session 1, age, gender, and event exposure.|Odds Ratio (OR)|1.4|STANDARD_ERROR_OF_MEAN|0.14|<|0.005|TWO_SIDED|95.0|1.071|1.85|||Regression, Logistic|||||1.85|1.071|< 0.005
71873431|NCT01326533|143265243|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||ANCOVA|Adjusted for baseline value as covariate||||||0.013
71873432|NCT00926211|143265244|NON_INFERIORITY_OR_EQUIVALENCE|Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.|Mean Difference (Net)|-1.4|STANDARD_DEVIATION|15.5||0.023|ONE_SIDED|97.5||3.9||t-test comparison to the upper limit of the non-inferiority margin|t-test, 1 sided|Paired t-test compared to the non-inferiority margin of 4 follicles.|The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.|The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.||3.9||0.023
71683442|NCT00236899|142885345|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.345||95.0|0.87|1.5|||Regression, Cox|||||1.50|0.87|0.345
71873433|NCT00926211|143265245|NON_INFERIORITY_OR_EQUIVALENCE|Study was powered for the primary efficacy outcome.|Mean Difference (Final Values)|0.045|STANDARD_DEVIATION|0.146|<|0.001|ONE_SIDED|97.5|-0.004||||t-test, 1 sided|Paired t-test.||Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.|||-.004|<0.001
71873434|NCT00078754|143265246|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANCOVA|||||||0.622
71873435|NCT00078754|143265247|SUPERIORITY|||||||0.029||||||LHA score main effect.|ANCOVA|The LHA Score F\[1,83\] = 4.91, p = 0.029; Condition F\[2,83\] = 0.20, p = 0.815; Condition x LHA Score F\[2,83\] = 0.255, p = 0.799.||The hypothesis was that subjects with LHA Scores = 18 or more would respond better to divalproex (than fluoxetine) while those with LHA scores = or \< 17 would respond better to fluoxetine (than divalproex).||||0.029
71873436|NCT00078754|143265247|SUPERIORITY||Mean Difference (Final Values)|19.0|STANDARD_ERROR_OF_MEAN|2.7||0.8|TWO_SIDED||||||ANCOVA|Baseline OAS-M Aggression score as covariate.||ANCOVA at endpoint with baseline OAS-M AGG score as covariate.||||0.80
71873437|NCT01106404|143265248|SUPERIORITY_OR_OTHER||binomial proportion|0.865|||<|0.001|ONE_SIDED|97.5|0.765||||Fisher Exact||In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|"ITT analysis:~Hypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p \> 0.25"|||0.765|< 0.001
71873438|NCT01106404|143265248|SUPERIORITY_OR_OTHER||binomial proportion|0.901|||<|0.001|ONE_SIDED|97.5|0.807||||Fisher Exact||In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|Completed case analysis|||0.807|< 0.001
71873439|NCT01106404|143265249|SUPERIORITY_OR_OTHER||binomial proportion|0.028|||||TWO_SIDED|95.0|0.003|0.098|||||The combined percentage of subjects with worsened pain relief was reported.|||0.098|0.003|
71873440|NCT01106404|143265250|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.8|STANDARD_DEVIATION|51.9|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
71873441|NCT01106404|143265251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_DEVIATION|1.93|<|0.001||95.0|||||Wilcoxon signed rank test|||||||< 0.001
71873442|NCT01106404|143265251|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_DEVIATION|2.04|<|0.001|TWO_SIDED|95.0|||||Wilcoxon signed rank test|||||||< 0.001
71873443|NCT03552822|143265259|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71873444|NCT03552822|143265260|SUPERIORITY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||||||0.037
71873445|NCT03552822|143265261|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71873446|NCT03552822|143265262|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71873447|NCT03552822|143265263|SUPERIORITY|||||||0.108|||||||Wilcoxon (Mann-Whitney)|||||||0.108
71873448|NCT03552822|143265264|SUPERIORITY|||||||0.159|||||||Fisher Exact|||||||0.159
71873449|NCT03552822|143265265|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71873450|NCT03552822|143265266|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.020
71873451|NCT03552822|143265267|SUPERIORITY|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
71683443|NCT00236899|142885346|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.885|TWO_SIDED|95.0|0.69|1.37|||Regression, Cox|||||1.37|0.69|0.885
71683444|NCT00236899|142885347|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.976|TWO_SIDED|95.0|0.71|1.42|||Regression, Cox|||||1.42|0.71|0.976
71683445|NCT00236899|142885348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.442||||0.0028|TWO_SIDED|95.0|0.259|0.754|||Regression, Logistic|||||0.754|0.259|0.0028
71683446|NCT00236899|142885349|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.15|TWO_SIDED|95.0|0.93|1.62|||Regression, Cox|||||1.62|0.93|0.150
71683447|NCT00236899|142885350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.818||||0.4567|TWO_SIDED|95.0|0.482|1.389|||Regression, Logistic|||||1.389|0.482|0.4567
71683448|NCT00236899|142885352|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.142
71683449|NCT00236899|142885352|SUPERIORITY_OR_OTHER|||||||0.47||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.470
71915486|NCT01634100|143352037|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.47|STANDARD_DEVIATION|7.4|||TWO_SIDED|90.0|146.41|160.88|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||160.88|146.41|
71915487|NCT01634100|143352038|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|175.14|STANDARD_DEVIATION|15.4|||TWO_SIDED|90.0|160.14|191.56|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||191.56|160.14|
71915488|NCT01634100|143352038|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|125.6|STANDARD_DEVIATION|15.9|||TWO_SIDED|90.0|113.67|138.78|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||138.78|113.67|
71915489|NCT01634100|143352039|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|136.42|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|130.61|142.48|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||142.48|130.61|
71915490|NCT01634100|143352039|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.61|STANDARD_DEVIATION|7.5|||TWO_SIDED|90.0|146.5|161.06|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the intra-subject coefficient of variation.|||161.06|146.50|
71915491|NCT02809846|143352055|OTHER|Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.|||||<|0.05||||||Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.|Mixed Models Analysis|Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.||Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05|Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike's Information Criteria to determine optimal covariance structure.|||<0.05
71915492|NCT01512693|143352056|NON_INFERIORITY_OR_EQUIVALENCE|Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval \[0.40, 2.50\].|GMR|0.85|||||TWO_SIDED|90.0|0.61|1.19||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.19|0.61|
71915493|NCT01512693|143352057|SUPERIORITY_OR_OTHER||GMR|0.71|||||TWO_SIDED|90.0|0.51|1.0||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.||1.00|0.51|
71915494|NCT01975376|143352060|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.930905|TWO_SIDED|95.0|0.8|1.22|||Log Rank|||Hazard ratio and 95 percent (%) Confidence Interval (CI) were from a Cox proportional hazards model stratified by geographic region and low density lipoprotein cholesterol (LDL-C) at pre-screening (less than \[\<\] 100 milligrams per deciliters \[mg/dL\], greater than and equal to \[\>=\] 100 mg/dL) with treatment as a co-variate.||1.22|0.80|0.930905
71915495|NCT01975376|143352061|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.784265|TWO_SIDED|95.0|0.82|1.3|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.30|0.82|0.784265
71915496|NCT01975376|143352062|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.892441|TWO_SIDED|95.0|0.81|1.2|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.20|0.81|0.892441
71915497|NCT01975376|143352063|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.845797|TWO_SIDED|95.0|0.83|1.26|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.26|0.83|0.845797
71915498|NCT01975376|143352064|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.431903|TWO_SIDED|95.0|0.49|1.36|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.36|0.49|0.431903
71683450|NCT00236899|142885353|SUPERIORITY_OR_OTHER|||||||0.293||95.0||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.293
71915499|NCT01975376|143352065|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.883797|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.21|0.80|0.883797
71915500|NCT01975376|143352066|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.45569|TWO_SIDED|95.0|0.74|1.95|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.95|0.74|0.455690
71915501|NCT01975376|143352067|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.469496|TWO_SIDED|95.0|0.84|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.84|0.469496
71915502|NCT01975376|143352068|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.633022|TWO_SIDED|95.0|0.26|9.23|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||9.23|0.26|0.633022
71915503|NCT01975376|143352069|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.46765|TWO_SIDED|95.0|0.83|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.48|0.83|0.467650
71915504|NCT01975376|143352070|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.015462|TWO_SIDED|95.0|0.32|0.89|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.89|0.32|0.015462
71915505|NCT01975376|143352071|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.011863|TWO_SIDED|95.0|0.33|0.88|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.88|0.33|0.011863
71915506|NCT01975376|143352072|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.316066|TWO_SIDED|95.0|0.12|2.0|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||2.00|0.12|0.316066
71915507|NCT01975376|143352073|SUPERIORITY||Hazard Ratio (HR)|0.52||||0.020328|TWO_SIDED|95.0|0.3|0.91|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||0.91|0.30|0.020328
71915508|NCT01975376|143352074|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.367069|TWO_SIDED|95.0|0.53|1.27|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.27|0.53|0.367069
71915509|NCT01975376|143352075|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.443081|TWO_SIDED|95.0|0.56|1.29|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.29|0.56|0.443081
71915510|NCT01975376|143352076|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.343817|TWO_SIDED|95.0|0.71|1.12|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.12|0.71|0.343817
71915511|NCT01975376|143352077|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.889065|TWO_SIDED|95.0|0.59|1.85|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.85|0.59|0.889065
71915512|NCT01975376|143352078|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.308388|TWO_SIDED|95.0|0.69|1.13|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.13|0.69|0.308388
71915513|NCT01975376|143352079|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.874835|TWO_SIDED|95.0|0.74|1.42|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.42|0.74|0.874835
71915514|NCT01975376|143352080|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.526269|TWO_SIDED|95.0|0.79|1.6|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL) with treatment as a covariate.||1.60|0.79|0.526269
71915515|NCT01975376|143352081|SUPERIORITY||LS-mean difference|-60.57|||<|0.001|TWO_SIDED|95.0|-61.43|-59.71|||Mixed Effect Model Repeat Measurement|||Lease Square (LS)- mean differences, associated 95% CI, and p-values were from a mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-59.71|-61.43|<0.001
71915516|NCT01975376|143352082|SUPERIORITY||LS-mean difference|-54.7|||<|0.001|TWO_SIDED|95.0|-55.48|-53.92|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-53.92|-55.48|<0.001
71915517|NCT01975376|143352083|SUPERIORITY||LS-mean difference|-46.72|||<|0.001|TWO_SIDED|95.0|-47.68|-45.76|||ANCOVA|||LS- mean difference and associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-45.76|-47.68|<0.001
71683451|NCT00236899|142885353|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact|||||||0.476
71683452|NCT03379792|142885356|OTHER|||||||0.24|||||||t-test, 2 sided|||||||0.24
71683453|NCT03379792|142885356|OTHER|||||||0.22|||||||t-test, 2 sided|||||||0.22
71683454|NCT03379792|142885356|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71683455|NCT03924505|142885375|SUPERIORITY||Incidence Rate Ratio|2.15|||<|0.01|TWO_SIDED|95.0|1.42|2.35||A priori threshold for statistical significance set at p\<0.05|Negative Binomial Regression|We adjusted for baseline rate due to baseline differences.|The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||2.35|1.42|<0.01
71683456|NCT03924505|142885376|SUPERIORITY||Incidence Rate Ratio|1.97||||0.01|TWO_SIDED|95.0|1.18|3.3||A priori threshold for statistical signicance is p\<0.05|Negative Binomial Regression||The incidence rate ratio estimates the effect of facilitation for implementation effectiveness and dissemination of best practice recommendations, as compared to dissemination of best practice recommendations.|||3.30|1.18|0.01
71873452|NCT02240693|143265323|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.075||0.3236|TWO_SIDED|95.0|-0.074|0.223||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.223|-0.074|0.3236
71873453|NCT02240693|143265323|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.076||0.3694|TWO_SIDED|95.0|-0.22|0.082||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.082|-0.220|0.3694
71873454|NCT02240693|143265323|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.078||0.8374|TWO_SIDED|95.0|-0.171|0.139||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.139|-0.171|0.8374
71873455|NCT02240693|143265323|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.077||0.5484|TWO_SIDED|95.0|-0.106|0.199||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.199|-0.106|0.5484
71915518|NCT01975376|143352084|SUPERIORITY||LS-mean difference|-54.88|||<|0.001|TWO_SIDED|95.0|-55.66|-54.09|||Mixed Effect Model Repeat Measurement|||Non-HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-54.09|-55.66|<0.001
71915519|NCT01975376|143352084|SUPERIORITY||LS-mean difference|-36.51|||<|0.001|TWO_SIDED|95.0|-37.07|-35.95|||Mixed Effect Model Repeat Measurement|||Total cholesterol: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-35.95|-37.07|<0.001
71683457|NCT03924505|142885377|OTHER|Testing for differences in means|Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.4||0.68|TWO_SIDED|95.0|-0.7|1.0|||t-test, 2 sided|||||1.0|-0.7|0.68
71683458|NCT00568334|142885381|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.|GMT Ratio|1.12|||||TWO_SIDED|95.0|0.86|1.46|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.46|0.86|
71683459|NCT00568334|142885382|NON_INFERIORITY|The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.93|1.33|||ANOVA|||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.||1.33|0.93|
71683460|NCT00306787|142885403|NON_INFERIORITY_OR_EQUIVALENCE|The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.|Median Difference (Final Values)|0.16|||||TWO_SIDED|95.0|-0.15|0.6|||Hodges-Lehman|||Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.||0.60|-0.15|
71683461|NCT02273908|142885409|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.949|||<|0.001|TWO_SIDED|95.0|-1.459|-0.439|||Mixed Models Analysis|||||-0.439|-1.459|<0.001
71683462|NCT02273908|142885410|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-2.259|||<|0.001|TWO_SIDED|95.0|-3.131|-1.387|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-1.387|-3.131|<0.001
71683463|NCT02273908|142885410|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.887|||<|0.001|TWO_SIDED|95.0|-2.704|-1.071|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-1.071|-2.704|<0.001
71683464|NCT02273908|142885411|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3018|||<|0.001|TWO_SIDED|95.0|1.4903|5.1133|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||5.1133|1.4903|<0.001
71683465|NCT02273908|142885411|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|2.729||||0.004|TWO_SIDED|95.0|0.9047|4.5533|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.5533|0.9047|0.004
71683466|NCT02273908|142885412|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.83|||<|0.001|TWO_SIDED|95.0|-1.301|-0.359|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||-0.359|-1.301|<0.001
71683467|NCT02273908|142885412|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.674||||0.004|TWO_SIDED|95.0|-1.125|-0.223|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||-0.223|-1.125|0.004
71683468|NCT02273908|142885413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0204||||0.175|TWO_SIDED|95.0|-0.0091|0.0499|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||0.0499|-0.0091|0.175
71683469|NCT02273908|142885413|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0329||||0.017|TWO_SIDED|95.0|0.0058|0.06|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||0.0600|0.0058|0.017
71683470|NCT02273908|142885414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.697||||0.026|TWO_SIDED|95.0|0.552|8.842|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.||8.842|0.552|0.026
71873456|NCT02240693|143265323|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.054||0.7905|TWO_SIDED|95.0|-0.092|0.121||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.121|-0.092|0.7905
71873457|NCT02240693|143265324|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|1.102||0.8973|TWO_SIDED|95.0|-2.33|2.04||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|2.04|-2.33|0.8973
71683471|NCT02273908|142885414|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.292||||0.477|TWO_SIDED|95.0|-2.282|4.866|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.||4.866|-2.282|0.477
71683472|NCT02273908|142885415|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
71683473|NCT02273908|142885416|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Modified Chi-squared|||||||<0.001
71683474|NCT04908475|142885419|SUPERIORITY||Adjusted Difference|50.7|||<|0.001|TWO_SIDED|95.0|41.3|60.1||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||60.1|41.3|< 0.001
71683475|NCT04908475|142885420|SUPERIORITY||Adjusted Difference|56.8|||<|0.001|TWO_SIDED|95.0|47.7|66.0||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\]) for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||66.0|47.7|< 0.001
71683476|NCT04908475|142885421|SUPERIORITY||Difference|69.7|||<|0.001|TWO_SIDED|95.0|59.5|80.0|||Chi-squared|||||80.0|59.5|< 0.001
71683477|NCT04908475|142885422|SUPERIORITY||Adjusted Difference|65.9|||<|0.001|TWO_SIDED|95.0|57.6|73.9||Adjusted for strata (baseline body weight \[≤ 100 kg, \> 100 kg\] and prior exposure to any systemic and/or biologic treatment for psoriasis \[0, ≥ 1\] for the comparison of 2 treatment groups.|Cochran-Mantel-Haenszel|||||73.9|57.6|< 0.001
71683478|NCT04908475|142885423|SUPERIORITY||Difference|71.6|||<|0.001|TWO_SIDED|95.0|60.9|82.3|||Chi-squared|||||82.3|60.9|< 0.001
71683479|NCT04908475|142885424|SUPERIORITY||Difference|69.4|||<|0.001|TWO_SIDED|95.0|58.6|80.2|||Chi-squared|||||80.2|58.6|< 0.001
71683480|NCT01593254|142885446|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71683481|NCT00076999|142885455|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
71683482|NCT00076999|142885455|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.78
71683483|NCT00076999|142885456|SUPERIORITY_OR_OTHER|||||||0||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
71683484|NCT00076999|142885456|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71873458|NCT02240693|143265324|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|1.122||0.2141|TWO_SIDED|95.0|-0.82|3.63||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|3.63|-0.82|0.2141
71873459|NCT02240693|143265324|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.085||0.6553|TWO_SIDED|95.0|-2.64|1.67||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.67|-2.64|0.6553
71873460|NCT02240693|143265324|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|1.144||0.7166|TWO_SIDED|95.0|-1.85|2.69||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|2.69|-1.85|0.7166
71873461|NCT02240693|143265325|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9491|TWO_SIDED|95.0|-0.49|0.46||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.46|-0.49|0.9491
71873462|NCT02240693|143265325|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1699|TWO_SIDED|95.0|-0.15|0.84||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.84|-0.15|0.1699
71873463|NCT02240693|143265325|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.26||0.4948|TWO_SIDED|95.0|-0.69|0.33||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.33|-0.69|0.4948
71873464|NCT02240693|143265325|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.25||0.7548|TWO_SIDED|95.0|-0.42|0.58||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.58|-0.42|0.7548
71873465|NCT02240693|143265326|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|1.081||0.8137|TWO_SIDED|95.0|-2.4|1.89||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.89|-2.40|0.8137
71873466|NCT02240693|143265326|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|1.12||0.5801|TWO_SIDED|95.0|-2.84|1.6||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|1.60|-2.84|0.5801
71915520|NCT01975376|143352084|SUPERIORITY||LS-mean difference|-20.17|||<|0.001|TWO_SIDED|95.0|-21.42|-18.93|||Mixed Effect Model Repeat Measurement|||VLDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-18.93|-21.42|<0.001
71915521|NCT01975376|143352084|SUPERIORITY||LS-Mean Difference|-30.25|||<|0.001|TWO_SIDED|95.0|-32.44|-28.07|||Mixed Effect Model Repeat Measurement|||RLP-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-28.07|-32.44|<0.001
71683485|NCT00076999|142885457|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
71683486|NCT00076999|142885457|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683487|NCT00076999|142885458|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.12
71683488|NCT00076999|142885458|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683489|NCT00076999|142885459|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.01
71683490|NCT00076999|142885459|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683491|NCT00076999|142885460|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.06
71683492|NCT00076999|142885460|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683493|NCT00076999|142885461|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.60
71683494|NCT00076999|142885461|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683495|NCT00076999|142885462|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.20
71873467|NCT02240693|143265326|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.072||0.2978|TWO_SIDED|95.0|-3.25|1.0||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|1.00|-3.25|0.2978
71873468|NCT02240693|143265326|SUPERIORITY|Analyses of covariance (ANCOVA) were used to assess between-group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|1.072||0.0209|TWO_SIDED|95.0|-4.64|-0.39||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|-0.39|-4.64|0.0209
71683496|NCT00076999|142885462|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683497|NCT00076999|142885463|SUPERIORITY_OR_OTHER|||||||0.18||95.0|||||Fisher Exact|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.18
71683498|NCT00076999|142885463|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||1.00
71683499|NCT00076999|142885465|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.02
71683500|NCT00076999|142885465|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.47
71683501|NCT00076999|142885466|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
71683502|NCT00076999|142885466|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.81
71683503|NCT00076999|142885467|SUPERIORITY_OR_OTHER|||||||0||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.00
71683504|NCT00076999|142885467|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.69
71683505|NCT00076999|142885469|SUPERIORITY_OR_OTHER|||||||0.64||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.64
71683506|NCT00076999|142885469|SUPERIORITY_OR_OTHER|||||||0.26||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.26
71683507|NCT00076999|142885470|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.25
71683508|NCT00076999|142885470|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.70
71683509|NCT00076999|142885471|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.73
71683510|NCT00076999|142885471|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.79
71683511|NCT00076999|142885473|SUPERIORITY_OR_OTHER|||||||0.38||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.38
71683512|NCT00076999|142885473|SUPERIORITY_OR_OTHER|||||||0.2||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.20
71683513|NCT00076999|142885474|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.08
71683514|NCT00076999|142885474|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.36
71683515|NCT00076999|142885475|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 2-\<6 yrs versus TPV OS 6-\<12 yrs||||0.23
71683516|NCT00076999|142885475|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs||||0.23
71683517|NCT04964986|142885483|SUPERIORITY|||||||0.041|||||||paired t-test|||||||0.041
71683518|NCT04964986|142885485|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 24||||<0.001
71683519|NCT04964986|142885485|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
71683520|NCT04964986|142885489|SUPERIORITY|||||||0.002|||||||paired t-test|||Week 24||||0.002
71683521|NCT04964986|142885489|SUPERIORITY||||||<|0.001|||||||paired t-test|||Week 52||||<0.001
71683522|NCT04964986|142885491|SUPERIORITY|||||||0.294|||||||paired t-test|||Fat absorption increase at Week 4||||0.294
71683523|NCT04964986|142885491|SUPERIORITY|||||||0.155|||||||paired t-test|||Fat absorption increase at Week 48||||0.155
71683524|NCT04964986|142885491|SUPERIORITY|||||||0.26|||||||paired t-test|||Carbohydrate absorption at Week 4||||0.260
71683525|NCT04964986|142885491|SUPERIORITY|||||||0.024|||||||paired t-test|||Carbohydrate absorption at Week 48||||0.024
71683526|NCT04964986|142885491|SUPERIORITY|||||||0.096|||||||paired t-test|||Protein absorption at Week 4||||0.096
71683527|NCT04964986|142885491|SUPERIORITY|||||||0.075|||||||paired t-test|||Protein absorption at Week 48||||0.075
71683528|NCT04964986|142885492|SUPERIORITY|||||||0.063|||||||paired t-test|||Week 4||||0.063
71683529|NCT04964986|142885492|SUPERIORITY|||||||0.112|||||||paired t-test|||Week 48||||0.112
71873469|NCT02240693|143265327|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.056||0.8694|TWO_SIDED|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.120|-0.101|0.8694
71873470|NCT02240693|143265327|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.057||0.9512|TWO_SIDED|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|0.109|-0.116|0.9512
71883063|NCT00385255|143285393|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertactin (PRN) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.7|||||TWO_SIDED|95.0|0.6|0.81|||ANCOVA|||Difference in adjusted GMC ratio for anti-PRN antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.||0.81|0.60|
71683530|NCT04964986|142885493|SUPERIORITY|||||||0.306|||||||paired t-test|||||||0.306
71683531|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|0.3346||||0.704|TWO_SIDED|95.0|-0.7887|0.8748|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 4||0.8748|-0.7887|0.704
71683532|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|-0.104||||0.488|TWO_SIDED|95.0|-2.7442|0.8896|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Calcium, Week 48||0.8896|-2.7442|0.488
71683533|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|-0.219||||0.382|TWO_SIDED|95.0|-0.896|0.313|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 4||0.313|-0.896|0.382
71683534|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|-1.566||||0.059|TWO_SIDED|95.0|-5.279|-0.165|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Magnesium, Week 48||-0.165|-5.279|0.059
71683535|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|33.116||||0.004|TWO_SIDED|95.0|5.51|51.861|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 4||51.861|5.510|0.004
71683536|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|20.727||||0.337|TWO_SIDED|95.0|-27.758|55.828|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Sodium, Week 48||55.828|-27.758|0.337
71683537|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|1.618||||0.724|TWO_SIDED|95.0|-11.87|14.931|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 4||14.931|-11.870|0.724
71683538|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|-9.19||||0.115|TWO_SIDED|95.0|-18.88|3.737|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Potassium, Week 48||3.737|-18.880|0.115
71683539|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|12.297||||0.707|TWO_SIDED|95.0|-39.551|52.617|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 4||52.617|-39.551|0.707
71683540|NCT04964986|142885494|SUPERIORITY||Mean Difference (Final Values)|-91.487||||0.009|TWO_SIDED|95.0|-159.956|-20.068|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Urea, Week 48||-20.068|-159.956|0.009
71683541|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|0.281||||0.572|TWO_SIDED|95.0|-0.649|0.96|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 4||0.960|-0.649|0.572
71683542|NCT04964986|142885494|SUPERIORITY||Median Difference (Final Values)|-0.136||||0.981|TWO_SIDED|95.0|-1.06|1.073|||paired t-test||Based on one-sample (paired) Hodges-Lehmann median estimator for non-parametric estimate of change from baseline.|Creatinine, Week 48||1.073|-1.060|0.981
71683543|NCT04964986|142885495|SUPERIORITY|||||||0.066|||||||paired t-test|||Week 24||||0.066
71683544|NCT04964986|142885495|SUPERIORITY|||||||0.015|||||||paired t-test|||Week 52||||0.015
71683545|NCT05821296|142885504|OTHER|Change of sum of total lesions at the end of the study from baseline/Day 0 to evaluate the efficacy and clinical performance of Crystal Peel for the treatment of acne.|Mean Difference (Final Values)|-14.58|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-17.31|-11.84|||ANCOVA|||||-11.84|-17.31|<0.0001
71683546|NCT05821296|142885505|OTHER||Mean Difference (Final Values)|1.85|STANDARD_DEVIATION|0.87|||TWO_SIDED|95.0|1.54|2.16||||||||2.16|1.54|
71873471|NCT02240693|143265327|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.056||0.9321|TWO_SIDED|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.115|-0.105|0.9321
71873472|NCT02240693|143265327|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.057||0.1288|TWO_SIDED|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.025|-0.199|0.1288
71873473|NCT02240693|143265327|SUPERIORITY|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.041||0.6492|TWO_SIDED|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward-Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|0.061|-0.098|0.6492
71873474|NCT03291587|143265331|SUPERIORITY|With 418 analyzable participants across 13 clinics per group, we have 80% power to detect a group difference in primary outcome (7-day abstinence). This assumes control abstinence rate will be 10% versus 20% intervention rate using a 2-sided Z-test for proportions with alpha=0.05 (2-sided). To account for the clustering we used an intra-class correlation value of 0.03. We plan to enroll 1114-1300 patients (or approximately 42-50 per site) to conservatively allow for 25%- 35.5% loss to follow-up.|Odds Ratio (OR)|0.967||||0.865|TWO_SIDED|96.0|0.652|1.433|||Mixed Models Analysis|||A generalized estimating equation marginal model was used in an intent-to-treat analysis to predict the 7-day tobacco use binary outcome. A binomial distribution with logit link was specified with group, time, and the interaction of group by time included as covariates while allowing intercept and time to vary by participants within site with an exchangeable working correlation matrix designation.||1.433|0.652|0.865
71873475|NCT02197767|143265335|SUPERIORITY|||||||0.072|||||||t-test, 2 sided|||||||0.072
71873476|NCT02197767|143265336|SUPERIORITY|||||||0.068|||||||t-test, 2 sided|||||||0.068
71873477|NCT00413972|143265347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
71873478|NCT00413972|143265347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
71873479|NCT00413972|143265347|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANOVA|||||||<.0001
71873480|NCT00381303|143265355|NON_INFERIORITY_OR_EQUIVALENCE|Test for non-inferiority (Delta=15%)|Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|0.052||0.3|TWO_SIDED|95.0|-19.85|0.68||P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)|Regression, Logistic|Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.||"Confidence interval of the difference in proportion of response between two sexes estimated by:~* Application of delta method to be obtained Standard Error (SE)~* Calculation of lower and upper bound using normal approximation to the difference in response rates"||0.68|-19.85|0.30
71873481|NCT03933774|143265365|SUPERIORITY|||||||0.002||||||P value \< 0.05 was considered significant.|t-test, 2 sided|||Null hypothesis: The degree of hyperpigmentation is the same between the tretinoin applied side and placebo applied side.||||0.002
71683547|NCT05821296|142885506|OTHER||Mean Difference (Final Values)|1.82|STANDARD_DEVIATION|1.07|||TWO_SIDED|95.0|1.44|2.2||||||||2.20|1.44|
71683548|NCT05821296|142885507|OTHER||Mean value in local tolerance score|2.21|STANDARD_DEVIATION|0.65|||TWO_SIDED|95.0|1.98|2.44||||||||2.44|1.98|
71683549|NCT05821296|142885508|OTHER|Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.|% of patients with positive answers|79.0|||||TWO_SIDED|95.0|61.0|89.0||||||||89|61|
71683550|NCT05821296|142885508|OTHER||% of patients with positive answers|94.0|||||TWO_SIDED|95.0|80.0|98.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||98|80|
71683551|NCT05821296|142885508|OTHER||% of patients with positive answers|88.0|||||TWO_SIDED|95.0|73.0|95.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||95|73|
71683552|NCT05821296|142885508|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|68.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|68|
71683553|NCT05821296|142885508|OTHER||% of patients with positive answers|91.0|||||TWO_SIDED|95.0|77.0|97.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||97|77|
71683554|NCT05821296|142885508|OTHER||% of patients with positive answers|85.0|||||TWO_SIDED|95.0|69.0|93.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||93|69|
71683555|NCT05821296|142885508|OTHER||% of patients with positive answers|78.0|||||TWO_SIDED|95.0|61.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|61|
71683556|NCT05821296|142885508|OTHER||% of patients with positive answers|79.0|||||TWO_SIDED|95.0|62.0|89.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||89|62|
71683557|NCT05821296|142885508|OTHER||% of patients with positive answers|76.0|||||TWO_SIDED|95.0|59.0|87.0||||||Descriptive analysis of subjects' satisfaction questionnaire assessing the Crystal Peel in the treatment of acne.||87|59|
71873482|NCT03933774|143265366|SUPERIORITY|||||||0.479||||||P value \< 0.05 was considered significant.|McNemar|||Null hypothesis: The number of participants who showed ≥75% repigmentation is the same between the tretinoin applied side and placebo applied side.||||0.479
71873483|NCT01966471|143265367|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.827||95.0|0.71|1.32|||Log Rank|||||1.32|0.71|0.8270
71873484|NCT01966471|143265368|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9291||95.0|0.77|1.34|||Log Rank|||||1.34|0.77|0.9291
71873485|NCT01966471|143265369|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8756||95.0|0.74|1.3|||Log Rank|||||1.30|0.74|0.8756
71873486|NCT01966471|143265370|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9341||95.0|0.75|1.31|||Log Rank|||||1.31|0.75|0.9341
71873487|NCT01966471|143265371|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4577||95.0|0.61|1.25|||Log Rank|||||1.25|0.61|0.4577
71873488|NCT01966471|143265372|SUPERIORITY||Hazard Ratio (HR)|1.24||||0.2864||95.0|0.83|1.84|||Log Rank|||||1.84|0.83|0.2864
71873489|NCT00954421|143265416|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.6|STANDARD_DEVIATION|19.4||0.026|TWO_SIDED|95.0|-30.61|-4.65|||two-sided sign-rank test||p-value assessed via sign-rank test (pre-planned method)|The null hypothesis is that the mean change in Tremor Rating Scale score from baseline to six months post-implant (with VIM and VO stimulators turned ON) will be zero||-4.65|-30.61|.026
71873490|NCT00954421|143265417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.4|STANDARD_DEVIATION|9.1||0.011|TWO_SIDED|95.0|2.2|14.5||Sign rank test was pre-planned for P-value|Sign-Rank test||p-value assessed using sign rank test|The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when both stimulators are on (VIM and VO), versus when both stimulators are off, will be zero (i.e., that there will be no difference in effect between having both stimulators on versus both stimulators off)||14.5|2.2|0.011
71873491|NCT00954421|143265417|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.73|STANDARD_DEVIATION|8.49||0.68||95.0|-4.96|6.42|||two-sided sign rank test|two sided sign rank test as pre-planned||The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when VO is on and VIM is off, versus when VIM is on and VO is off, will be zero (i.e., that there will be no difference in effect between having exclusively VIM versus VO on)||6.42|-4.96|.68
71683558|NCT05821296|142885510|OTHER||Mean Difference (Net)|-47.24|STANDARD_DEVIATION|56.61|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
71683559|NCT05821296|142885510|OTHER||Mean Difference (Final Values)|-30.85|STANDARD_DEVIATION|63.92||0.01|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.010
71683560|NCT05821296|142885510|OTHER||Mean Difference (Final Values)|-41.69|STANDARD_DEVIATION|73.69|<|0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||<0.004
71873492|NCT05245097|143265420|OTHER|For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully conditional specification (FCS) discriminant function method will be used to impute missing primary endpoint using the baseline covariates of age, sex, race, ethnicity, mobility level, and BIMS Score. The FCS logistic method was replaced with the FCS discriminant function method due to a quasi-separation caused by only one observed primary endpoint event in the treatment group.||||||0.004||||||The null hypothesis was tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare treatment groups while controlling for propensity score.|Regression, Logistic|||||||0.004
71873493|NCT05245097|143265421|OTHER|||||||0.003||||||The hip fracture due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|||||||0.003
71873494|NCT05245097|143265421|SUPERIORITY|||||||0.003|||||||Regression, Logistic|||||||0.003
71873495|NCT05245097|143265422|SUPERIORITY|||||||0.001||||||The emergency department visit due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple ED visits due to falls are only counted once.||||||0.001
71873496|NCT05245097|143265423|SUPERIORITY|||||||0.003||||||The hospitalization due to fall rate was compared between treatment groups using firth logistic regression while controlling for propensity score. A one-sided 0.025 level of significance was used.|Regression, Logistic|Subjects with multiple hospitalizations due to falls are only counted once.||||||0.003
71873497|NCT00692978|143265457|EQUIVALENCE|Log transformed parametric ANOVA|||||<|0.05||||||calculated|ANOVA|||||||<0.05
71873498|NCT00607022|143265458|OTHER|Kruskal-Wallis values between each loading group and for Wilcoxon Signed Rank for measures on the mesial vs buccal side of the implant.|||||>|0.05||||||0.0501 \< p \< 0.9797|Kruskal-Wallis|Kruskal-Wallis test evaluated ISQ at each time point..||Comparison between loading groups at 16 weeks - loading at baseline, Loading at 6 weeks, and loading at 12 weeks. Scores for all groups were compared at 16 weeks from implant placement..||||>0.05
71683561|NCT05821296|142885510|OTHER||Mean Difference (Final Values)|-29.13|STANDARD_DEVIATION|61.45||0.013|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous number of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.013
71683562|NCT05821296|142885511|OTHER||Mean Difference (Final Values)|-2832.39|STANDARD_DEVIATION|3217.15|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 15 to evaluate the improvement of pores assessed by Colorface device.||||< 0.0001
71683563|NCT05821296|142885511|OTHER||Mean Difference (Final Values)|-1754.88|STANDARD_DEVIATION|4220.25||0.025|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.025
71683564|NCT05821296|142885511|OTHER||Mean Difference (Final Values)|-2763.41|STANDARD_DEVIATION|4965.84||0.004|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.004
71683565|NCT05821296|142885511|OTHER||Mean Difference (Final Values)|-1742.41|STANDARD_DEVIATION|3974.21||0.021|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous area of detected pores at day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.021
71683566|NCT05821296|142885512|OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|1.3|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
71683567|NCT05821296|142885512|OTHER||Mean Difference (Final Values)|-0.68|STANDARD_DEVIATION|1.68||0.029|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.029
71873499|NCT03254485|143265463|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.3681|TWO_SIDED|95.0|-0.95|0.35|||ANCOVA|||||0.35|-0.95|=0.3681
71873500|NCT03254485|143265464|SUPERIORITY||Least Squares Mean Difference|-16.74|||=|0.2817|TWO_SIDED|95.0|-47.38|13.9|||ANCOVA|||||13.90|-47.38|=0.2817
71873501|NCT03254485|143265465|SUPERIORITY||Least Squares Mean Difference|-0.297|||=|0.6508|TWO_SIDED|95.0|-1.591|0.997|||ANCOVA|||||0.997|-1.591|=0.6508
71873502|NCT01598311|143265484|NON_INFERIORITY|Non-inferiority was declared when the lower bound of the 95% CI for the difference in adjusted percentage of cured subjects was \> -10%.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-4.9|7.6||||||||7.6|-4.9|
71873503|NCT01598311|143265486|SUPERIORITY|Superiority was declared if the lower bound of the 95% CI of the adjusted difference in sustained response was \> 0.|Mean Difference (Final Values)|4.3|||||TWO_SIDED|95.0|-3.6|12.2||||||||12.2|-3.6|
71873504|NCT00720941|143265490|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be \<1.25.|Hazard Ratio (HR)|1.0466|||||TWO_SIDED|95.0|0.8982|1.2195|||||The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (\<=1.5xULN, \>1.5xULN).|||1.2195|0.8982|
71873505|NCT00604279|143265509|NON_INFERIORITY_OR_EQUIVALENCE|The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points|Least Square Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.48||||95.0|-5.2|0.63|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.63|-5.20|
71873506|NCT00604279|143265510|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.34||||95.0|-2.14|3.12|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||3.12|-2.14|
71683568|NCT05821296|142885512|OTHER||Mean Difference (Final Values)|-1.07|STANDARD_DEVIATION|2.01||0.006|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.006
71683569|NCT05821296|142885512|OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|1.67||0.037|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous relative area (density) of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.037
71873507|NCT00604279|143265511|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||||95.0|-0.33|0.1|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||||0.10|-0.33|
71873508|NCT00604279|143265512|SUPERIORITY_OR_OTHER||Least Square Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|2.08||||95.0|-0.67|7.5|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Quality of sleep||7.50|-0.67|
71873509|NCT00604279|143265512|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|2.02||||95.0|-5.04|2.9|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.||Statistical Analysis for Daytime drowsiness||2.90|-5.04|
71873510|NCT00604279|143265513|SUPERIORITY_OR_OTHER||Point estimate of relative risk|0.9||||||95.0|0.81|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.81|
71873511|NCT01072877|143265528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.49|||=|0.0001|TWO_SIDED|95.0|-3.72|-1.27|||ANCOVA|||||-1.27|-3.72|=0.0001
71873512|NCT01072877|143265528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.54|||<|0.0001|TWO_SIDED|95.0|-4.8|-2.29|||ANCOVA|||||-2.29|-4.80|<0.0001
71873513|NCT01072877|143265528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.98|-1.48|||ANCOVA|||||-1.48|-3.98|<0.0001
71683570|NCT05821296|142885513|OTHER||Mean Difference (Final Values)|-0.39|STANDARD_DEVIATION|0.58||0.001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.001
71683571|NCT05821296|142885513|OTHER||Mean Difference (Final Values)|-0.14|STANDARD_DEVIATION|0.71||0.348|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.348
71683572|NCT05821296|142885513|OTHER||Mean Difference (Final Values)|-0.27|STANDARD_DEVIATION|0.75||0.091|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.091
71873514|NCT01072877|143265528|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.65|||<|0.0001|TWO_SIDED|95.0|-4.84|-2.46|||ANCOVA|||||-2.46|-4.84|<0.0001
71873515|NCT01072877|143265529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|||=|0.0001|TWO_SIDED|95.0|-1.17|-0.4|||ANCOVA|||||-0.40|-1.17|=0.0001
71873516|NCT01072877|143265529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.26|||<|0.0001|TWO_SIDED|95.0|-1.65|-0.86|||ANCOVA|||||-0.86|-1.65|<0.0001
71873517|NCT01072877|143265529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45|||<|0.0001|TWO_SIDED|95.0|-1.85|-1.06|||ANCOVA|||||-1.06|-1.85|<0.0001
71873518|NCT01072877|143265529|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-1.98|-1.23|||ANCOVA|||||-1.23|-1.98|<0.0001
71873519|NCT01072877|143265530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|||=|0.0001|TWO_SIDED|95.0|-0.66|-0.23|||ANCOVA|||||-0.23|-0.66|=0.0001
71873520|NCT01072877|143265530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76|||<|0.0001|TWO_SIDED|95.0|-0.98|-0.53|||ANCOVA|||||-0.53|-0.98|<0.0001
71873521|NCT01072877|143265530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.97|-0.53|||ANCOVA|||||-0.53|-0.97|<0.0001
71683573|NCT05821296|142885513|OTHER||Mean Difference (Final Values)|-0.12|STANDARD_DEVIATION|0.65||0.19|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous depth of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.190
71873522|NCT01072877|143265530|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.11|-0.68|||ANCOVA|||||-0.68|-1.11|<0.0001
71873523|NCT00420017|143265541|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.02|TWO_SIDED|95.0|0.16|0.86|||Chi-squared|||||0.86|0.16|0.02
71873524|NCT00420017|143265542|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
71873525|NCT00420017|143265543|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.097
71873526|NCT00420017|143265544|SUPERIORITY_OR_OTHER|||||||0.66||95.0|||||Chi-squared|||||||0.66
71683574|NCT05821296|142885514|OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|3.55||0.011|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||0.011
71873527|NCT03548987|143265578|SUPERIORITY||Treatment difference|-14.75|||<|0.0001|TWO_SIDED|95.0|-16.0|-13.5|||ANCOVA|||Treatment policy estimand||-13.50|-16.00|<0.0001
71873528|NCT03548987|143265578|OTHER||Treatment difference|-15.33|||<|0.0001|TWO_SIDED|95.0|-16.52|-14.13|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-14.13|-16.52|<0.0001
71873529|NCT00752622|143265706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to evaluation Week 10.||||<.0001
71873530|NCT00752622|143265706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 30 of the Observational Phase.||||<.0001
71873531|NCT00752622|143265706|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 54 of the Observational Phase.||||<.0001
71873532|NCT00267631|143265728|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Chi-squared|||||||.026
71873533|NCT01777269|143265789|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.0|||<|0.001|TWO_SIDED|95.0|-10.22|-5.79|||mixed-model repeated-measures|||||-5.79|-10.22|<0.001
71873534|NCT01777269|143265790|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.11|||<|0.001|TWO_SIDED|95.0|-6.01|-2.21|||mixed-model repeated-measures||Month 1|||-2.21|-6.01|<0.001
71873535|NCT01777269|143265790|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.43|||<|0.001|TWO_SIDED|95.0|-8.45|-4.41|||Adjusted mean difference||Month 3|||-4.41|-8.45|<0.001
71873536|NCT01777269|143265790|SUPERIORITY_OR_OTHER||Adjusted mean difference|-9.04|||<|0.001|TWO_SIDED|95.0|-11.31|-6.77|||mixed-model repeated-measures||Month 6|||-6.77|-11.31|<0.001
71873537|NCT01777269|143265790|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.82|||<|0.001|TWO_SIDED|95.0|-10.96|-6.67|||mixed-model repeated-measures||Month 9|||-6.67|-10.96|<0.001
71873538|NCT01777269|143265792|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2||||0.37|TWO_SIDED|95.0|-0.62|0.23|||mixed-model repeated-measures||Month 1|||0.23|-0.62|0.37
71873539|NCT01777269|143265792|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24||||0.33|TWO_SIDED|95.0|-0.71|0.24|||mixed-model repeated-measures||Month 3|||0.24|-0.71|0.33
71873540|NCT01777269|143265792|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.37||||0.16|TWO_SIDED|95.0|-0.88|0.15|||mixed-model repeated-measures||Month 6|||0.15|-0.88|0.16
71873541|NCT01777269|143265792|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68||||0.009|TWO_SIDED|95.0|-1.19|-0.17|||mixed-model repeated-measures||Month 9|||-0.17|-1.19|0.009
71873542|NCT01777269|143265792|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46||||0.091|TWO_SIDED|95.0|-0.99|0.07|||mixed-model repeated-measures||Month 12|||0.07|-0.99|0.091
71873543|NCT01777269|143265793|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.89|||<|0.001|TWO_SIDED|95.0|-4.07|-1.7|||mixed-model repeated-measures||Month 1|||-1.70|-4.07|<0.001
71683575|NCT05821296|142885514|OTHER||Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|3.28||0.281|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.281
71683576|NCT05821296|142885514|OTHER||Mean Difference (Final Values)|-1.57|STANDARD_DEVIATION|4.46||0.06|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.060
71683577|NCT05821296|142885514|OTHER||Mean Difference (Final Values)|-0.87|STANDARD_DEVIATION|3.8||0.209|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of average area of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.209
71683578|NCT05821296|142885515|OTHER||Mean Difference (Final Values)|-26495.83|STANDARD_DEVIATION|33223.6|<|0.0001|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of detected pores at Day 15 to evaluate the improvement of pores assessed by Colorface device.||||<0.0001
71683579|NCT05821296|142885515|OTHER||Mean Difference (Final Values)|-14447.02|STANDARD_DEVIATION|44054.48||0.073|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 36 to evaluate the improvement of pores assessed by Colorface device.||||0.073
71683580|NCT05821296|142885515|OTHER|If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|Mean Difference (Final Values)|-25315.34|STANDARD_DEVIATION|49884.67||0.008|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 57 to evaluate the improvement of pores assessed by Colorface device.||||0.008
71683581|NCT05821296|142885515|OTHER||Mean Difference (Final Values)|-13287.34|STANDARD_DEVIATION|39615.92||0.071|TWO_SIDED|||||If the test provides a p-value less than 0.05, there is a significant variation over time for the analyzed parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of detected pores at Day 78 to evaluate the improvement of pores assessed by Colorface device.||||0.071
71683582|NCT05821296|142885516|OTHER||Mean Difference (Final Values)|-7518.25|STANDARD_DEVIATION|13340.45||0.003|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
71683583|NCT05821296|142885516|OTHER||Mean Difference (Final Values)|-7230.81|STANDARD_DEVIATION|17547.6||0.041|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.041
71873544|NCT01777269|143265793|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.24|||<|0.001|TWO_SIDED|95.0|-6.59|-3.9|||mixed-model repeated-measures||Month 3|||-3.90|-6.59|<0.001
71683584|NCT05821296|142885516|OTHER||Mean Difference (Final Values)|-9086.26|STANDARD_DEVIATION|18306.64||0.007|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
71873545|NCT01777269|143265793|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.82|||<|0.001|TWO_SIDED|95.0|-8.3|-5.34|||mixed-model repeated-measures||Month 6|||-5.34|-8.30|<0.001
71683585|NCT05821296|142885516|OTHER||Mean Difference (Final Values)|64.71|STANDARD_DEVIATION|14542.17||0.931|TWO_SIDED|||||If the Wilcoxon test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous area of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.931
71683586|NCT05821296|142885517|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_DEVIATION|0.66||0.005|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.005
71683587|NCT05821296|142885517|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.8||0.035|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.035
71683588|NCT05821296|142885517|OTHER||Mean Difference (Final Values)|-0.34|STANDARD_DEVIATION|0.86||0.036|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.036
71683589|NCT05821296|142885517|OTHER||Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.77||0.784|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|t-test, 2 sided|||Comparison of change from baseline of conspicuous depth of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.784
71873546|NCT01777269|143265793|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.05|||<|0.001|TWO_SIDED|95.0|-8.51|-5.59|||mixed-model repeated-measures||Month 9|||-5.59|-8.51|<0.001
71873547|NCT01777269|143265793|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.92|||<|0.001|TWO_SIDED|95.0|-8.47|-5.38|||mixed-model repeated-measures||Month 12|||-5.38|-8.47|<0.001
71873548|NCT01777269|143265794|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.94||||0.012|TWO_SIDED|95.0|-1.67|-0.21|||mixed-model repeated-measures||Month 1|||-0.21|-1.67|0.012
71873549|NCT01777269|143265794|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.93||||0.017|TWO_SIDED|95.0|-1.69|-0.17|||mixed-model repeated-measures||Month 3|||-0.17|-1.69|0.017
71873550|NCT01777269|143265794|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.57|-0.88|||mixed-model repeated-measures||Month 6|||-0.88|-2.57|<0.001
71873551|NCT01777269|143265794|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.15||||0.009|TWO_SIDED|95.0|-2.01|-0.3|||mixed-model repeated-measures||Month 9|||-0.30|-2.01|0.009
71873552|NCT01777269|143265794|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83||||0.047|TWO_SIDED|95.0|-1.65|-0.01|||mixed-model repeated-measures||Month 12|||-0.01|-1.65|0.047
71873553|NCT01777269|143265795|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.45|-0.85|||mixed-model repeated-measures||Week 2|||-0.85|-2.45|<0.001
71873554|NCT01777269|143265795|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55||||0.24|TWO_SIDED|95.0|-1.47|0.37|||mixed-model repeated-measures||Month 1|||0.37|-1.47|0.24
71915522|NCT01975376|143352084|SUPERIORITY||LS-Mean Difference|-58.55|||<|0.001|TWO_SIDED|95.0|-59.42|-57.69|||Mixed Effect Model Repeat Measurement|||Apo B: LS -mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||-57.69|-59.42|<0.001
71915523|NCT01975376|143352084|SUPERIORITY||LS-Mean Difference|6.14|||<|0.001|TWO_SIDED|95.0|5.69|6.59|||Mixed Effect Model Repeat Measurement|||HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||6.59|5.69|<0.001
71915524|NCT01975376|143352084|SUPERIORITY||LS-Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|3.02|4.03|||Mixed Effect Model Repeat Measurement|||Apo A-I: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, baseline value, baseline value\*visit interaction, geographic region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||4.03|3.02|<0.001
71915525|NCT01975376|143352085|SUPERIORITY||LS-mean difference|0.67|||<|0.001|TWO_SIDED|95.0|0.66|0.68|||Mixed Effect Model Repeat Measurement|||Lp (a): LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.68|0.66|<0.001
71915526|NCT01975376|143352085|SUPERIORITY||LS-mean difference|0.81|||<|0.001|TWO_SIDED|95.0|0.8|0.81|||Mixed Effect Model Repeat Measurement|||Triglycerides: LS- mean differences and associated 95% CI, and p-values were from an MMRM model through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||0.81|0.80|<0.001
71915527|NCT01975376|143352086|SUPERIORITY||LS-mean difference|1.06|||<|0.001|TWO_SIDED|95.0|1.03|1.1|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group\*visit interaction, log-transformed baseline value, log-transformed baseline value\*visit interaction, geographical region and LDL-C at pre-screening (\<100 mg/dL, \>=100 mg/dL).||1.10|1.03|<0.001
71915528|NCT03054740|143352125|SUPERIORITY||||||||||||||||||Levene's Test of Equality of Error Variances (Design: Intercept + Pain Previous IV + Intervention) F = .001, df1 = 1, df2=28, Sig. = .972|||
71915529|NCT03054740|143352126|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||.390
71915530|NCT01378299|143352134|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with last value carry forward.||||<0.05
71915531|NCT01378299|143352135|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward||||<0.05
71915532|NCT01378299|143352136|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915533|NCT01378299|143352137|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915534|NCT01378299|143352138|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71873555|NCT01777269|143265795|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.006|TWO_SIDED|95.0|-2.19|-0.36|||mixed-model repeated-measures||Month 3|||-0.36|-2.19|0.006
71915535|NCT01378299|143352139|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915536|NCT01378299|143352140|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915537|NCT01378299|143352142|OTHER||||||<|0.05|||||||ANOVA|||Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline and with acceptable assay coefficient of variability were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.||||<0.05
71915538|NCT01378299|143352143|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915539|NCT01378299|143352144|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915540|NCT01378299|143352145|OTHER||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.||||<0.05
71915541|NCT01448707|143352159|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.|Non-Linear mixed|-7.9||||0.2331|TWO_SIDED|95.0|-14.64|-1.19||P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).|Mixed Models Analysis|Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates||||-1.19|-14.64|0.2331
71873556|NCT01777269|143265795|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|||<|0.001|TWO_SIDED|95.0|-2.74|-0.72|||mixed-model repeated-measures||Month 6|||-0.72|-2.74|<0.001
71873557|NCT01777269|143265795|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.34||||0.013|TWO_SIDED|95.0|-2.4|-0.28|||mixed-model repeated-measures||Month 9|||-0.28|-2.40|0.013
71873558|NCT01777269|143265795|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|||<|0.001|TWO_SIDED|95.0|-3.12|-0.83|||mixed-model repeated-measures||Month 12|||-0.83|-3.12|<0.001
71873559|NCT01777269|143265796|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4||||0.036|TWO_SIDED|95.0|-0.78|-0.03|||mixed-model repeated-measures||Week 2|||-0.03|-0.78|0.036
71683590|NCT05821296|142885518|OTHER||Mean Difference (Final Values)|-2249.72|STANDARD_DEVIATION|4466.14||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.||Comparison of change from baseline of conspicuous length of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.011
71873560|NCT01777269|143265796|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.0||||1|TWO_SIDED|95.0|-0.37|0.37|||mixed-model repeated-measures||Month 1|||0.37|-0.37|1.00
71873561|NCT01777269|143265796|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26||||0.21|TWO_SIDED|95.0|-0.67|0.15|||mixed-model repeated-measures||Month 3|||0.15|-0.67|0.21
71873562|NCT01777269|143265796|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62||||0.009|TWO_SIDED|95.0|-1.09|-0.15|||mixed-model repeated-measures||Month 6|||-0.15|-1.09|0.009
71873563|NCT01777269|143265796|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.45||||0.056|TWO_SIDED|95.0|-0.91|0.01|||mixed-model repeated-measures||Month 9|||0.01|-0.91|0.056
71873564|NCT01777269|143265796|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.58||||0.023|TWO_SIDED|95.0|-1.08|-0.08|||mixed-model repeated-measures||Month 12|||-0.08|-1.08|0.023
71873565|NCT01777269|143265797|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|||<|0.001|TWO_SIDED|95.0|-3.89|-2.1|||mixed-model repeated-measures||Week 2|||-2.10|-3.89|<0.001
71873566|NCT01777269|143265797|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|||<|0.001|TWO_SIDED|95.0|-3.15|-1.06|||mixed-model repeated-measures||Month 1|||-1.06|-3.15|<0.001
71873567|NCT01777269|143265797|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.11|||<|0.001|TWO_SIDED|95.0|-3.25|-0.98|||mixed-model repeated-measures||Month 3|||-0.98|-3.25|<0.001
71873568|NCT01777269|143265797|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.53|||<|0.001|TWO_SIDED|95.0|-3.76|-1.3|||mixed-model repeated-measures||Month 6|||-1.30|-3.76|<0.001
71873569|NCT01777269|143265797|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3||||0.042|TWO_SIDED|95.0|-2.56|-0.05|||mixed-model repeated-measures||Month 9|||-0.05|-2.56|0.042
71873570|NCT01777269|143265797|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.51|||<|0.001|TWO_SIDED|95.0|-4.87|-2.14|||mixed-model repeated-measures||Month 12|||-2.14|-4.87|<0.001
71873571|NCT01777269|143265798|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.78|||<|0.001|TWO_SIDED|95.0|-10.07|-5.49|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=2 points improvement at any time post-baseline visit|||-5.49|-10.07|<0.001
71873572|NCT01777269|143265798|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.39|||<|0.001|TWO_SIDED|95.0|-9.79|-4.99|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=3 points improvement at any time post-baseline visit|||-4.99|-9.79|<0.001
71873573|NCT01777269|143265799|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.79|||<|0.001|TWO_SIDED|95.0|-10.22|-5.35|||mixed-model repeated-measures||Par. with IPSS change from baseline \>=25 points improvement at any time post-baseline visit|||-5.35|-10.22|<0.001
71873574|NCT00504881|143265801|SUPERIORITY_OR_OTHER||Percent Reduction over Placebo|7.3|||=|0.125|TWO_SIDED|95.0|-2.2|15.9|||ANCOVA|||ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.||15.9|-2.2|=0.125
71873575|NCT00593957|143265836|SUPERIORITY_OR_OTHER||||||<|0.4|||||||t-test, 2 sided|||||||<0.40
71873576|NCT00593957|143265836|SUPERIORITY_OR_OTHER||||||<|0.62||95.0|||||t-test, 2 sided|||||||<0.62
71873577|NCT00593957|143265836|SUPERIORITY_OR_OTHER||||||<|0.38||95.0|||||t-test, 2 sided|||||||<0.38
71873578|NCT00593957|143265838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.38|||<|0.1|||||||ANOVA|||Null hypothesis is that there would be no significant difference in social abilities as measured by the SSI score in this treatment group baseline to 6 months post-treatment.||||<0.10
71873579|NCT00593957|143265838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|||<|0.5|||||||ANOVA|||||||<0.50
71873580|NCT00593957|143265838|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|||<|0.48|||||||ANOVA|||||||<0.48
71873581|NCT00593957|143265839|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.947|||<|0.05|||||||ANOVA|||||||<0.05
71873582|NCT01163721|143265852|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-0.53|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.93|-0.13||P-value is from an Analysis of Covariance (ANCOVA) model with treatment as factor and baseline HbA1c value as covariate. Due to the exploratory nature of this study, there were no adjustments for multiplicity.|ANCOVA|||Assuming a common standard deviation of 1.1%, 60 evaluable participants would provide 93% power to detect a statistically significant -1.0% difference in change from baseline HbA1c at Week 12 between ranolazine and placebo (2-sided alpha = 0.05). 80 participants were randomized to ensure at least 60 evaluable participants.||-0.13|-0.93|0.010
71873583|NCT01163721|143265853|SUPERIORITY_OR_OTHER||difference in LSM|-15.4|STANDARD_ERROR_OF_MEAN|12.83||0.234|TWO_SIDED|95.0|-41.0|10.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||10.2|-41.0|0.234
71873584|NCT01163721|143265854|SUPERIORITY_OR_OTHER||difference in least squares mean (LSM)|-2.5|STANDARD_ERROR_OF_MEAN|9.38||0.794|TWO_SIDED|95.0|-21.1|16.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA|||||16.2|-21.1|0.794
71873585|NCT02511678|143265855|SUPERIORITY|||||||0.0746||||||The 1-sided p-value was based on a t-test against a performance goal of -2.|t-test, 1 sided|||||||0.0746
71873586|NCT01295281|143265865|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Two catheters were tested regarding subjects' perception when using them, in a cross over design. After using each catheter for 1 week the subjects were asked: Do you experience discomfort when using your catheter?, and the subjects were supposed to answer Yes or No. The hypothesis to be investigated was that the tolerability/perception was about the same for each type of catheter, i.e. the POBE 2.0 should be non-inferior compared to PVC. H0: p(disc. POBE - Yes) = p(disc. PVC - Yes)"||||||0.0066|||||||McNemar|||The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.||||0.0066
71683591|NCT05821296|142885518|OTHER||Mean Difference (Final Values)|-2315.0|STANDARD_DEVIATION|6197.86||0.074|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.074
71683592|NCT05821296|142885518|OTHER||Mean Difference (Final Values)|-2700.55|STANDARD_DEVIATION|5962.3||0.007|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.007
71683593|NCT05821296|142885518|OTHER||Mean Difference (Final Values)|430.65|STANDARD_DEVIATION|5021.2||0.779|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous length of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
71683594|NCT05821296|142885519|OTHER||Mean Difference (Final Values)|-75800.75|STANDARD_DEVIATION|142643.92||0.003|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 15 to evaluate the improvement of line marks assessed by Colorface device.||||0.003
71873587|NCT05461794|143265898|OTHER||Odds Ratio (OR)|2.1|||||TWO_SIDED|95.0|0.3|23.9|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||23.9|0.3|
71683595|NCT05821296|142885519|OTHER||Mean Difference (Final Values)|-73517.86|STANDARD_DEVIATION|197224.85||0.054|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 36 to evaluate the improvement of line marks assessed by Colorface device.||||0.054
71873588|NCT05461794|143265898|OTHER||Risk Difference (RD)|5.0|||||TWO_SIDED|95.0|-9.3|19.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||19.5|-9.3|
71873589|NCT05461794|143265900|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.45|1.61|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||1.61|0.45|
71873590|NCT05461794|143265901|OTHER||Odds Ratio (OR)|2.5|||||TWO_SIDED|95.0|0.9|6.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||6.8|0.9|
71873591|NCT05461794|143265901|OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.3|3.7|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||3.7|0.3|
71873592|NCT05461794|143265901|OTHER||Risk Difference (RD)|22.0|||||TWO_SIDED|95.0|-1.5|43.3|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||43.3|-1.5|
71873593|NCT05461794|143265901|OTHER||Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-24.5|28.4|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||28.4|-24.5|
71873594|NCT05461794|143265902|OTHER||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|0.7|40.8|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||40.8|0.7|
71873595|NCT05461794|143265902|OTHER||Odds Ratio (OR)|0.6|||||TWO_SIDED|95.0|0.1|2.9|||||The odds ratio was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||2.9|0.1|
71683596|NCT05821296|142885519|OTHER||Mean Difference (Final Values)|-90424.89|STANDARD_DEVIATION|198264.2||0.008|TWO_SIDED|||||If the test provides a p-value less than 0.05, the variation is significant over time for the studied parameter.|Wilcoxon (Mann-Whitney)|||Comparison of change from baseline of conspicuous volume of line marks at Day 57 to evaluate the improvement of line marks assessed by Colorface device.||||0.008
71683597|NCT05821296|142885519|OTHER||Mean Difference (Final Values)|1314.03||||0.779|TWO_SIDED||||||t-test, 2 sided|||Comparison of change from baseline of conspicuous volume of line marks at Day 78 to evaluate the improvement of line marks assessed by Colorface device.||||0.779
71873596|NCT05461794|143265902|OTHER||Risk Difference (RD)|12.7|||||TWO_SIDED|95.0|-2.3|29.5|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||29.5|-2.3|
71873597|NCT05461794|143265902|OTHER||Risk Difference (RD)|-8.4|||||TWO_SIDED|95.0|-34.7|13.8|||||The risk difference was estimated along with their exact unconditional 95% CIs constructed by the tail method based on the score statistics.|||13.8|-34.7|
71873598|NCT05461794|143265903|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.29|0.96|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||0.96|0.29|
71873599|NCT05461794|143265903|OTHER||Hazard Ratio (HR)|1.96|||||TWO_SIDED|95.0|0.79|4.82|||||Hazard ratio and 95% CIs were estimated using a Cox regression model stratified by the selected stratification factors PD-L1 tumor area positivity score (\>=10% versus \< 10%)|||4.82|0.79|
71873600|NCT05461794|143265904|OTHER||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.1|2.7|||||The crude odds ratio was estimated along with exact unconditional 95% CIs constructed by the tail method based on the score statistics|||2.7|0.1|
71873601|NCT00467285|143265906|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||comparison of changes in BMD at 6months compared to baseline||||<0.05
71873602|NCT02684357|143265913|OTHER||Adjusted percentage difference|72.5|||<|0.001|TWO_SIDED|95.0|66.8|78.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||78.2|66.8|< 0.001
71915542|NCT01448707|143352160|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-Linear mixed|-10.1||||0.6933|TWO_SIDED|95.0|-19.5|-0.73|||Mixed Models Analysis|||||-0.73|-19.50|0.6933
71873603|NCT02684357|143265914|OTHER||Adjusted percentage difference|78.5|||<|0.001|TWO_SIDED|95.0|72.4|84.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.5|72.4|< 0.001
71873604|NCT02684357|143265915|OTHER||Adjusted percentage difference|47.5|||<|0.001|TWO_SIDED|95.0|40.9|54.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.2|40.9|< 0.001
71683598|NCT00497770|142885541|NON_INFERIORITY_OR_EQUIVALENCE|A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was \<1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%.|Odds Ratio (OR)|0.821|||||TWO_SIDED|95.0|0.427|1.58||Adjusted:baseline characteristics, income, marital/insurance status, comorbid, time between end of 1st line therapy and start of pemetrexed, prior platinum- or Paclitaxel-containing regimen, number of cycles and best response during 1st line therapy.|Regression, Logistic|||||1.580|0.427|
71683599|NCT03409120|142885555|SUPERIORITY||||||<|0.001|||||||linear mixed effects model|||We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.||||<0.001
71683600|NCT00386425|142885581|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for change to Day 7|t-test, 2 sided|||||||0.011
71683601|NCT00386425|142885582|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||p-value is for the moderate Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.047
71683602|NCT00386425|142885582|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for the severe Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided|||||||0.063
71683603|NCT00386425|142885583|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||p-value is for Day 28 mortality|Fisher Exact|||||||0.030
71683604|NCT00386425|142885584|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||p-value is for Day 90 mortality|Fisher Exact|||||||0.090
71915543|NCT01448707|143352161|NON_INFERIORITY_OR_EQUIVALENCE|Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-linear mixed model|-3.5||||0.0016|TWO_SIDED|95.0|-8.77|1.72|||Mixed Models Analysis|||||1.72|-8.77|0.0016
71915544|NCT01448707|143352161|NON_INFERIORITY_OR_EQUIVALENCE|Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|non-linear mixed model|-0.7||||0.0022|TWO_SIDED|95.0|-7.89|6.58|||Mixed Models Analysis|||||6.58|-7.89|0.0022
71915545|NCT02512276|143352226|SUPERIORITY||Mean Difference (Net)|4.7|||||TWO_SIDED|95.0|3.0|6.4||||||||6.4|3.0|
71915546|NCT02512276|143352227|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.91|1.22||||||||1.22|0.91|
71915547|NCT02512276|143352228|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.94|1.28||||||||1.28|0.94|
71915548|NCT02512276|143352229|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.45|0.85||||||||0.85|0.45|
71683605|NCT00386425|142885585|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for total SOFA difference between alternative and standard therapy|t-test, 2 sided|||||||0.190
71683606|NCT00386425|142885585|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||p-value is for difference in cardiovascular SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.268
71683607|NCT00386425|142885585|SUPERIORITY_OR_OTHER|||||||0.082||95.0||||p-value is for difference in respiratory SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.082
71915549|NCT02512276|143352230|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.91|1.36||||||||1.36|0.91|
71915550|NCT02512276|143352231|SUPERIORITY||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.78|1.34||||||||1.34|0.78|
71915551|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.55||||0.003|TWO_SIDED|95.0|-0.91|-0.19|||t-test, 2 sided|||Corneal staining analysis, day 28.||-0.19|-0.91|0.003
71683608|NCT00386425|142885585|SUPERIORITY_OR_OTHER|||||||0.367||95.0||||p-value is for difference in renal SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.367
71683609|NCT00386425|142885585|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||p-value is for difference in hematology SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.274
71683610|NCT00386425|142885585|SUPERIORITY_OR_OTHER|||||||0.341||95.0||||p-value is for difference in liver SOFA between alternative and standard therapy|t-test, 2 sided|||||||0.341
71683611|NCT00386425|142885587|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for difference between participants normalizing protein C and not normalizing protein C.|Fisher Exact|||||||<0.0001
71683612|NCT00386425|142885588|SUPERIORITY_OR_OTHER|||||||0.622||95.0||||p-value is for 28-Day Mortality, Dead at Day 28 vs. Alive at Day 28|Pearson's chi-square test|||||||0.622
71683613|NCT00386425|142885588|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for Hospital Mortality|Fisher Exact|||||||0.815
71915552|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.19|TWO_SIDED|95.0|-1.28|0.28|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 18-59 year old subgroup.||0.28|-1.28|0.19
71915553|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.94||||0.047|TWO_SIDED|95.0|-1.86|-0.02|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, 60+ year old subgroup.||-0.02|-1.86|0.047
71915554|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.69||||0.08|TWO_SIDED|95.0|-1.49|0.1|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, Sjogren's subgroup.||0.10|-1.49|0.08
71915555|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.09|TWO_SIDED|95.0|-1.67|0.14|||t-test, 2 sided|||Corneal staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.67|0.09
71915556|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.68|||<|0.001|TWO_SIDED|95.0|-1.05|-0.3|||t-test, 2 sided|||Conjunctival staining analysis, day 28||-0.30|-1.05|< 0.001
71915557|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.58|TWO_SIDED|95.0|-1.04|0.61|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 18-59 year old subgroup.||0.61|-1.04|0.58
71915558|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-1.19||||0.021|TWO_SIDED|95.0|-2.17|-0.21|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, 60+ year old subgroup.||-0.21|-2.17|0.021
71915559|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.77||||0.16|TWO_SIDED|95.0|-1.88|0.34|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, Sjogren's subgroup.||0.34|-1.88|0.16
71915560|NCT04498468|143352266|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.097|TWO_SIDED|95.0|-1.55|0.14|||t-test, 2 sided|||Conjunctival staining sub-group analysis, day 28, non-Sjogren's subgroup.||0.14|-1.55|0.097
71683614|NCT00207727|142885675|SUPERIORITY_OR_OTHER|||||||0||95.0||||The p-value was non estimable because the observed trend was in the opposite direction of that stated in the one sided alternative hypothesis|Jonckheere Terpstra|Jonckheere Terpstra nonparametric trend test procedure with 5% level of significance was be used to test for the monotonic trend.||Hypothesis: The null hypothesis of no effect among the treatment groups was tested against the alternative hypothesis that the cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs through Week 23 would decrease monotonically with dose at a significance level of 0.05.||||0.00
71683615|NCT00207727|142885676|SUPERIORITY_OR_OTHER|||||||0.892||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.892
71683616|NCT00207727|142885676|SUPERIORITY_OR_OTHER|||||||0.599||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.599
71683617|NCT00207727|142885676|SUPERIORITY_OR_OTHER|||||||0.517||95.0|||||2-sided Wilcoxon Mann-Whitney|||||||0.517
71915561|NCT04498468|143352267|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.069|TWO_SIDED|95.0|-11.4|0.4|||t-test, 2 sided|||Eye dryness, day 28||0.4|-11.4|0.069
71683618|NCT00207727|142885676|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||2-sided Wilcoxon Mann-Whitney|||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group.||||0.967
71683619|NCT00207727|142885677|SUPERIORITY_OR_OTHER|||||||0.72||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.720
71915562|NCT04498468|143352267|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.92|TWO_SIDED|95.0|-7.0|6.3|||t-test, 2 sided|||VAS Eye discomfort, Day 28||6.3|-7.0|0.92
71915563|NCT04498468|143352267|SUPERIORITY||Mean Difference (Final Values)|-1.3||||0.55|TWO_SIDED|95.0|-5.8|3.1|||t-test, 2 sided|||VAS eye fatigue, day 28||3.1|-5.8|0.55
71915564|NCT04498468|143352268|SUPERIORITY||Risk Ratio (RR)|1.26||||0.42|TWO_SIDED|95.0|0.8|2.0|||McNemar|||||2.0|0.8|0.42
71915565|NCT04498468|143352269|SUPERIORITY||Risk Ratio (RR)|1.04||||1|TWO_SIDED|95.0|0.76|1.42|||McNemar|||||1.42|0.76|1.00
71915566|NCT02725268|143352271|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.178|TWO_SIDED|95.0|0.58|1.12||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.12|0.58|=0.178
71915567|NCT02725268|143352271|SUPERIORITY||Hazard Ratio (HR)|1.85|||=|0.092|TWO_SIDED|95.0|1.19|2.86||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.86|1.19|=0.092
71915568|NCT02725268|143352271|SUPERIORITY||Hazard Ratio (HR)|2.57|||=|0.147|TWO_SIDED|95.0|1.47|4.49||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||4.49|1.47|=0.147
71915569|NCT02725268|143352273|SUPERIORITY||Hazard Ratio (HR)|1.04|||=|0.968|TWO_SIDED|95.0|0.72|1.5||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.50|0.72|=0.968
71915570|NCT02725268|143352273|SUPERIORITY||Hazard Ratio (HR)|1.5|||=|0.145|TWO_SIDED|95.0|0.95|2.37||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.37|0.95|=0.145
71915571|NCT02725268|143352273|SUPERIORITY||Hazard Ratio (HR)|1.54|||=|0.243|TWO_SIDED|95.0|0.87|2.73||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.73|0.87|=0.243
71915572|NCT02725268|143352274|SUPERIORITY||Hazard Ratio (HR)|0.79|||=|0.17|TWO_SIDED|95.0|0.57|1.11||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||1.11|0.57|=0.170
71915573|NCT02725268|143352274|SUPERIORITY||Hazard Ratio (HR)|1.67|||=|0.224|TWO_SIDED|95.0|1.04|2.68||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||2.68|1.04|=0.224
71915574|NCT02725268|143352274|SUPERIORITY||Hazard Ratio (HR)|2.28|||=|0.244|TWO_SIDED|95.0|1.32|3.96||The p-value was obtained using stratified log-rank test with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|Stratified Log-rank Test||The hazard ratio was obtained using a stratified Cox proportional hazard model adjusted for histological subtype, lines of prior chemotherapy and prior taxane therapy. A hazard ratio of \<1 was considered statistically significant.|||3.96|1.32|=0.244
71683620|NCT00207727|142885677|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.152
71683621|NCT00207727|142885677|SUPERIORITY_OR_OTHER|||||||0.431||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||||||0.431
71683622|NCT00207727|142885677|SUPERIORITY_OR_OTHER|||||||0.292||95.0|||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo..||||0.292
71683623|NCT00435019|142885687|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.|Mean Difference (Final Values)|0.12||||||95.0|-0.12|0.36|||ANCOVA|||||0.36|-0.12|
71683624|NCT02440854|142885701|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.002
71683625|NCT02440854|142885701|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.014
71873605|NCT02684357|143265916|OTHER||Adjusted percentage difference|48.2|||<|0.001|TWO_SIDED|95.0|41.9|54.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||54.6|41.9|< 0.001
71915575|NCT02725268|143352275|SUPERIORITY||Odds Ratio (OR)|1.39|||||TWO_SIDED|95.0|0.66|2.9|||||The odds ratio and 95% confidence intervals were obtained using a stratified Cochran-Mantel-Haenszel (CMH) model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||2.90|0.66|
71915576|NCT02725268|143352275|SUPERIORITY||Odds Ratio (OR)|0.22|||||TWO_SIDED|95.0|0.04|1.14|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.14|0.04|
71915577|NCT02725268|143352275|SUPERIORITY||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.00|0.00|
71915578|NCT02725268|143352276|SUPERIORITY||Odds Ratio (OR)|3.02|||||TWO_SIDED|95.0|1.53|5.96|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||5.96|1.53|
71915579|NCT02725268|143352276|SUPERIORITY||Odds Ratio (OR)|0.4|||||TWO_SIDED|95.0|0.18|0.86|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.86|0.18|
71683626|NCT02440854|142885701|OTHER|||||||0.246|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.246
71683627|NCT02440854|142885701|OTHER|||||||0.103|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.103
71683628|NCT02440854|142885701|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.004
71683629|NCT02440854|142885701|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683630|NCT02440854|142885701|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.012
71683631|NCT02440854|142885701|OTHER|||||||0.024|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.024
71683632|NCT02440854|142885701|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.009
71683633|NCT02440854|142885701|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.008
71683634|NCT02440854|142885702|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.027
71683635|NCT02440854|142885702|OTHER|||||||0.03|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.030
71683636|NCT02440854|142885702|OTHER|||||||0.351|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.351
71683637|NCT02440854|142885702|OTHER|||||||0.143|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.143
71683638|NCT02440854|142885702|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.163
71915580|NCT02725268|143352276|SUPERIORITY||Odds Ratio (OR)|0.43|||||TWO_SIDED|95.0|0.15|1.21|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||1.21|0.15|
71683639|NCT02440854|142885702|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
71683640|NCT02440854|142885702|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
71683641|NCT02440854|142885702|OTHER|||||||0.036|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.036
71683642|NCT02440854|142885702|OTHER|||||||0.043|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.043
71915581|NCT02725268|143352277|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|0.89|7.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||7.67|0.89|
71915582|NCT02725268|143352277|SUPERIORITY||Odds Ratio (OR)|0.15|||||TWO_SIDED|95.0|0.05|0.51|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.51|0.05|
71915583|NCT02725268|143352277|SUPERIORITY||Odds Ratio (OR)|0.07|||||TWO_SIDED|95.0|0.01|0.67|||||The odds ratio and 95% confidence intervals were obtained using a stratified CMH model with histological subtype, lines of prior chemotherapy and prior taxane therapy (original stratification values).|||0.67|0.01|
71683643|NCT02440854|142885702|OTHER|||||||0.04|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.040
71683644|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71683645|NCT02440854|142885703|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.003
71683646|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71683647|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71683648|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71683649|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683650|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71683651|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71683652|NCT02440854|142885703|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
71683653|NCT02440854|142885703|OTHER|||||||0.163|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.163
71683654|NCT02440854|142885704|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.003
71683655|NCT02440854|142885704|OTHER|||||||0.009|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.009
71683656|NCT02440854|142885704|OTHER|||||||0.012|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.012
71683657|NCT02440854|142885704|OTHER|||||||0.332|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.332
71683658|NCT02440854|142885704|OTHER|||||||0.029|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.029
71683659|NCT02440854|142885704|OTHER|||||||0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.001
71683660|NCT02440854|142885704|OTHER|||||||0.177|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.177
71683661|NCT02440854|142885704|OTHER|||||||0.436|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.436
71683662|NCT02440854|142885704|OTHER|||||||0.302|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.302
71683663|NCT02440854|142885704|OTHER|||||||0.291|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.291
71683664|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71683665|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71683666|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71873606|NCT02684357|143265917|OTHER||Adjusted percentage difference|62.2|||<|0.001|TWO_SIDED|95.0|55.5|68.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||68.9|55.5|< 0.001
71873607|NCT02684357|143265918|OTHER||Adjusted percentage difference|31.2|||<|0.001|TWO_SIDED|95.0|25.7|36.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.6|25.7|< 0.001
71873608|NCT02684357|143265919|OTHER||Adjusted percentage difference|27.6|||<|0.001|TWO_SIDED|95.0|16.7|38.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||38.5|16.7|< 0.001
71873609|NCT02684357|143265920|OTHER||Adjusted percentage difference|22.3|||<|0.001|TWO_SIDED|95.0|12.0|32.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.5|12.0|< 0.001
71873610|NCT02684357|143265921|OTHER||Adjusted percentage difference|27.0|||<|0.001|TWO_SIDED|95.0|17.0|37.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||37.0|17.0|< 0.001
71873611|NCT02684357|143265922|OTHER||Adjusted percentage difference|26.3|||<|0.001|TWO_SIDED|95.0|16.1|36.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||36.4|16.1|< 0.001
71915584|NCT00412113|143352288|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|19.03|||<|0.001||95.0|9.14|39.63||There was only one primary endpoint and the p-value was not adjusted for comparison.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(\< 140/90 mmHg) and LDL goal (\< 100mg/dL) at Week 6.~With \~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP \<140/90 mmHg and LDL \<100 mg/dL and using a chi-square test with 0.05 two-sided significance level."||39.63|9.14|<0.001
71915585|NCT00412113|143352289|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|31.39|||<|0.001||95.0|12.61|78.09||No adjustment for p-value for secondary analysis|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<100 mg/dL) at Week 4.||78.09|12.61|<0.001
71873612|NCT02684357|143265923|OTHER||Adjusted percentage difference|30.2|||<|0.001|TWO_SIDED|95.0|19.6|40.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.9|19.6|< 0.001
71915586|NCT00412113|143352290|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.2|||<|0.001||95.0|2.93|9.24||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 4.||9.24|2.93|<0.001
71683667|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71683668|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71683669|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683670|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71683671|NCT02440854|142885705|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71873613|NCT02684357|143265924|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
71873614|NCT02684357|143265925|OTHER||Adjusted percentage difference|29.5|||<|0.001|TWO_SIDED|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.1|18.9|< 0.001
71873615|NCT02684357|143265926|OTHER||Adjusted percentage difference|19.2|||<|0.001|TWO_SIDED|95.0|9.5|28.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.8|9.5|< 0.001
71915587|NCT00412113|143352291|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.14|||<|0.001||95.0|2.89|9.11||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (\< 140/90 mmHg) and LDL-goal (\<130mg/dL) at Week 6.||9.11|2.89|<0.001
71915588|NCT00412113|143352292|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|65.51|||<|0.001||95.0|27.1|158.34||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (\<100mg/DL) at Week 4.||158.34|27.10|<0.001
71915589|NCT00412113|143352293|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|42.04|||<|0.001||95.0|19.42|90.99||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (\<100mg/DL) at Week 6.||90.99|19.42|<0.001
71915590|NCT00412113|143352294|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.785||95.0|0.6|1.98||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg)at Week 4||1.98|0.60|0.785
71915591|NCT00412113|143352295|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.55||||0.171||95.0|0.83|2.88||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (\< 140/90 mmHg) at Week 6.||2.88|0.83|0.171
71915592|NCT00412113|143352296|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.76||||0.585||95.0|-1.97|3.48||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.||3.48|-1.97|0.585
71915593|NCT00412113|143352297|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.0|||>|0.999||95.0|-2.01|2.01||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.||2.01|-2.01|> 0.999
71915594|NCT00412113|143352298|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.9||||0.363||95.0|-2.83|1.04|||ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.||1.04|-2.83|0.363
71915595|NCT00412113|143352299|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-3.25||||0.02||95.0|-5.99|-0.51||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.||-0.51|-5.99|0.020
71915596|NCT00412113|143352300|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.87||||0.351||95.0|-2.71|0.97||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.||0.97|-2.71|0.351
71915597|NCT00412113|143352301|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.1||||0.922||95.0|-1.91|2.11||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.||2.11|-1.91|0.922
71915598|NCT00412113|143352302|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-49.3|||<|0.001||95.0|-54.68|-43.91||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.||-43.91|-54.68|<0.001
71683672|NCT02440854|142885705|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.002
71915599|NCT00412113|143352303|SUPERIORITY_OR_OTHER_LEGACY||difference in LS Means|-0.3||||0.739||95.0|-2.07|1.47||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.||1.47|-2.07|0.739
71683673|NCT02440854|142885705|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
71683674|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71683675|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71915600|NCT00412113|143352304|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-57.9|||<|0.001||95.0|-64.02|51.81||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.||51.81|-64.02|<0.001
71873616|NCT02684357|143265927|OTHER||Adjusted percentage difference|18.0|||<|0.001|TWO_SIDED|95.0|7.8|28.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||28.3|7.8|< 0.001
71873617|NCT02684357|143265928|OTHER||Adjusted percentage difference|20.2|||<|0.001|TWO_SIDED|95.0|9.1|31.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.4|9.1|< 0.001
71873618|NCT02684357|143265929|OTHER||Mean Difference (Final Values)|-6.375|||<|0.001|TWO_SIDED|95.0|-7.102|-5.648|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.648|-7.102|< 0.001
71873619|NCT02684357|143265930|OTHER||Adjusted percentage difference|84.7|||<|0.001|TWO_SIDED|95.0|79.0|90.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||90.4|79.0|< 0.001
71873620|NCT02684357|143265931|OTHER||Adjusted percentage difference|29.1|||<|0.001|TWO_SIDED|95.0|18.5|39.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||39.6|18.5|< 0.001
71873621|NCT02684357|143265932|OTHER||Adjusted percentage difference|14.7||||0.001|TWO_SIDED|95.0|5.9|23.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.|||23.5|5.9|0.001
71873622|NCT03714425|143265976|SUPERIORITY||||||<|0.05||||||The primary research objective to measure perceived improvement in pain at three months was assessed using a two-sample t-test of PGIC scores between the two treatment groups using a type I error rate of 0.05 (two-sided).|t-test, 2 sided|Most of the analyses involved delta scores reflecting changes within subjects, though we compared PGIC raw scores rather than change scores.||||||<0.05
71873623|NCT03019796|143265978|OTHER|||||||0.04|||||||ANOVA|repeated measures||||||0.040
71873624|NCT03019796|143265979|OTHER|||||||0.054|||||||ANOVA|repeated measures||||||0.054
71683676|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71683677|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71683678|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71683679|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683680|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71683681|NCT02440854|142885706|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71683682|NCT02440854|142885706|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.003
71683683|NCT02440854|142885706|OTHER|||||||0.025|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.025
71873625|NCT03019796|143265980|OTHER|||||||0.04|||||||ANOVA|REPEATED MEASURES||||||0.040
71873626|NCT03019796|143265981|OTHER|||||||0.321|||||||ANOVA|REPEATED MEASURES||||||0.321
71873627|NCT03019796|143265982|OTHER|||||||0.401|||||||ANOVA|REPEATED MEASURES||||||0.401
71873628|NCT03019796|143265983|OTHER|||||||0.021|||||||ANOVA|REPEATED MEASURES||||||0.021
71873629|NCT01658826|143266032|SUPERIORITY||Risk Ratio (RR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.3|0.63|||non-linear mixed effects model|||||0.63|0.30|<0.0001
71873630|NCT06515483|143266050|OTHER||Mean Difference (Final Values)|0.079||||0.323|TWO_SIDED|95.0|-0.095|0.254||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.254|-0.095|0.323
71873631|NCT06515483|143266050|OTHER||Mean Difference (Final Values)|-0.036||||0.371|TWO_SIDED|95.0|-0.156|0.084||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day PLI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.084|-0.156|0.371
71915601|NCT00412113|143352305|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-47.27|||<|0.001||95.0|-63.37|-31.16||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.||-31.16|-63.37|<0.001
71915602|NCT00412113|143352306|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-51.21|||<|0.001||95.0|-56.88|-45.55||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.||-45.55|-56.88|<0.001
71915603|NCT00412113|143352307|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.02||||0.329||95.0|-3.07|1.03||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.||1.03|-3.07|0.329
71873632|NCT06515483|143266050|OTHER||Mean Difference (Net)|-0.115||||0.12|TWO_SIDED|95.0|-0.262|0.031||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in PLI from baseline to 30 days between groups|||0.031|-0.262|0.120
71873633|NCT06515483|143266051|OTHER||Mean Difference (Final Values)|0.078||||0.27|TWO_SIDED|95.0|-0.048|0.204||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||0.204|-0.048|0.270
71873634|NCT06515483|143266051|OTHER||Mean Difference (Final Values)|-0.085||||0.071|TWO_SIDED|95.0|-0.203|0.033||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day MGI between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.033|-0.203|0.071
71873635|NCT06515483|143266051|OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.249|-0.077|||t-test, 2 sided||Comparing the mean difference in MGI from baseline to 30 days between groups|||-0.077|-0.249|<0.001
71873636|NCT06515483|143266052|OTHER||Mean Difference (Final Values)|0.31||||0.902|TWO_SIDED|95.0|-6.23|6.85||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing baseline BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at baseline were compared using non-parametric Wilcoxon Rank Sum tests.||6.85|-6.23|0.902
71873637|NCT06515483|143266052|OTHER||Mean Difference (Final Values)|-8.22||||0.006|TWO_SIDED|95.0|-16.46|0.02||The threshold for statistical significance was p \< 0.05.|Wilcoxon (Mann-Whitney)||Comparing 30-day BOMP between groups|Due to non-normally distributed data, differences in each index between the experimental and control groups at 30 days were compared using non-parametric Wilcoxon Rank Sum tests.||0.02|-16.46|0.006
71873638|NCT06515483|143266052|OTHER||Mean Difference (Net)|-8.53||||0.032|TWO_SIDED|95.0|-16.31|-0.75||The threshold for statistical significance was p \< 0.05.|t-test, 2 sided||Comparing the mean difference in BOMP from baseline to 30 days between groups|||-0.75|-16.31|0.032
71873639|NCT02425644|143266064|SUPERIORITY||Rate ratio|0.695||||0.0003|TWO_SIDED|99.0|0.536|0.902|||Negative binomial regression model|||||0.902|0.536|0.0003
71873640|NCT02425644|143266065|SUPERIORITY||Mean Difference (Final Values)|-3.57||||0.0019|TWO_SIDED|95.0|-5.83|-1.32|||Mixed Models Analysis|||||-1.32|-5.83|0.0019
71873641|NCT02425644|143266066|SUPERIORITY||Rate Ratio|0.444|||<|0.0001|TWO_SIDED|95.0|0.364|0.542|||Negative binomial regression model|||||0.542|0.364|<.0001
71873642|NCT02425644|143266067|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.2939|TWO_SIDED|95.0|0.58|1.18|||Log Rank|||||1.18|0.58|0.2939
71873643|NCT02425644|143266068|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.372|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3720
71873644|NCT00568321|143266099|SUPERIORITY||LS Mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.43||0.687|TWO_SIDED|90.0|-0.5|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Least square (LS) mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.50|0.687
71873645|NCT00568321|143266099|SUPERIORITY||LS Mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.44||0.111|TWO_SIDED|90.0|-1.25|0.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||LS mean difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.19|-1.25|0.111
71683684|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71873646|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.41||0.399|TWO_SIDED|90.0|-0.79|0.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.58|-0.79|0.399
71873647|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.42||0.189|TWO_SIDED|90.0|-1.06|0.32|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.32|-1.06|0.189
71873648|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.42||0.802|TWO_SIDED|90.0|-0.33|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.33|0.802
71915604|NCT00412113|143352308|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-62.07|||<|0.001||95.0|-68.49|-55.65||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.||-55.65|-68.49|<0.001
71915605|NCT00412113|143352309|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-53.95|||<|0.001||95.0|-77.61|-30.29||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.||-30.29|-77.61|<0.001
71873649|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.582|TWO_SIDED|90.0|-0.61|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.61|0.582
71915606|NCT00412113|143352310|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.4|||<|0.001||95.0|-3.1|-1.7||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.||-1.7|-3.1|<0.001
71915607|NCT00412113|143352311|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.8|||<|0.001||95.0|-3.5|-2.1||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.||-2.1|-3.5|<0.001
71915608|NCT01998906|143352319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6||||0.0051|TWO_SIDED|95.0|5.0|30.2|||Chi-squared|||||30.2|5.0|0.0051
71915609|NCT01998906|143352320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.3||||0.0014|TWO_SIDED|95.0|7.2|31.4|||Chi-squared|||||31.4|7.2|0.0014
71915610|NCT01998906|143352321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.4||||0.3077|TWO_SIDED|95.0|-6.4|19.1|||Chi-squared|||||19.1|-6.4|0.3077
71915611|NCT01998906|143352323|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0275|TWO_SIDED|95.0|0.44|0.96|||Log Rank|||||0.96|0.44|0.0275
71915612|NCT01998906|143352325|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.59||||0.0555|TWO_SIDED|95.0|0.35|1.02|||Log Rank|||||1.02|0.35|0.0555
71915613|NCT01077193|143352342|NON_INFERIORITY_OR_EQUIVALENCE|See above.|Mean Percent Excess Weight Loss|37.9|STANDARD_DEVIATION|25.18||0.3227|TWO_SIDED|95.0|30.2|45.5||No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.|t-test, 1 sided|||A sample size of 32 achieves power\>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.||45.5|30.2|0.3227
71915614|NCT04283773|143352347|SUPERIORITY||Median Difference (Final Values)|0.001|STANDARD_DEVIATION|1.5||0.001|TWO_SIDED|95.0|0.0|8.0||The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.|Kruskal-Wallis|||Assessment of statistical differences in P16 expression between 3 groups. The immunohistochemical evaluation is done using German- semiquantitative scoring system. The score ranges from ( 0, 1,2,3,4,6,8,9 and 12). The data will entered on SPSS,version 24 as numbers. The test of significance is Kruskal Wallis was used to examine the Difference in Median between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons . A p-value \< 0.05 was considered significant.||8|0|0.001
71915615|NCT04283773|143352348|SUPERIORITY||Hazard Ratio, log|0.009||||0.009|TWO_SIDED|95.0|0.0|8.0||Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.|Spearman's rank correlation coefficient(|||Correlation between Ki 67 expression using percentage of Ki67 positive nuclei and P16 cytoplasmic expression using German semi quantitative score among MOGCT group. Data were analysed using IBM-SPSS version 24. Correlation analysis was used (Spearman' Ranked correlation, 2-tailed). A p-value \< 0.05 was considered significant.||8|0|0.009
71915616|NCT04283773|143352349|SUPERIORITY|One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|1.5||0.699|TWO_SIDED|80.0|9.5|13.0||One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD). P value is significant if less than 0.05.|ANOVA|||Correlation between P16 cytoplasmic score using German semi-quantitative system and FIGO staging of MOGCTs was done via One-way ANOVA was used to examine the Difference in Mean between groups. Post-hoc test with Bonferroni Correction was used for Pairwise comparisons .Data was expressed as mean (SD).||13|9.5|0.699
71683685|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71873650|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.42||0.789|TWO_SIDED|90.0|-0.36|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.36|0.789
71915617|NCT06048809|143352352|OTHER|||||||2.36e-05|||||||ANCOM-BC2|||Haemophilus parainfluenzae: Change From Baseline at Week 6||||0.0000236
71915618|NCT06048809|143352352|OTHER|||||||0.0033243|||||||ANCOM-BC2|||Neisseria elongata: Change From Baseline at Week 6||||0.0033243
71683686|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71683687|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71683688|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71915619|NCT06048809|143352352|OTHER|||||||0.00500088|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_898: Change From Baseline at Week 6||||0.00500088
71915620|NCT06048809|143352352|OTHER|||||||0.0066975|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_110: Change From Baseline at Week 6||||0.0066975
71915621|NCT06048809|143352352|OTHER|||||||0.00710228|||||||ANCOM-BC2|||Aggregatibacter aphrophilus: Change From Baseline at Week 6||||0.00710228
71915622|NCT06048809|143352352|OTHER|||||||0.00744022|||||||ANCOM-BC2|||Kingella oralis: Change From Baseline at Week 6||||0.00744022
71915623|NCT06048809|143352352|OTHER|||||||0.01434037|||||||ANCOM-BC2|||Haemophilus sp.\_HMT\_036: Change From Baseline at Week 6||||0.01434037
71683689|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683690|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71683691|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71873651|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.42||0.29|TWO_SIDED|90.0|-0.94|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-0.94|0.290
71873652|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.568|TWO_SIDED|90.0|-0.65|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.65|0.568
71873653|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.45||0.116|TWO_SIDED|90.0|-1.27|0.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.20|-1.27|0.116
71873654|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.46||0.218|TWO_SIDED|90.0|-1.11|0.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.40|-1.11|0.218
71873655|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.46||0.261|TWO_SIDED|90.0|-1.06|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.06|0.261
71873656|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.48||0.252|TWO_SIDED|90.0|-1.11|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.11|0.252
71873657|NCT00568321|143266100|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.49||0.182|TWO_SIDED|90.0|-1.26|0.36|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.36|-1.26|0.182
71873658|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.39||0.683|TWO_SIDED|90.0|-0.46|0.84|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.84|-0.46|0.683
71873659|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.31|TWO_SIDED|90.0|-0.85|0.46|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.46|-0.85|0.310
71873660|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.37||0.668|TWO_SIDED|90.0|-0.46|0.78|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.78|-0.46|0.668
71873661|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.38||0.165|TWO_SIDED|90.0|-0.99|0.26|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.26|-0.99|0.165
71873662|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.36||0.546|TWO_SIDED|90.0|-0.55|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-0.55|0.546
71915624|NCT06048809|143352352|OTHER|||||||0.01955327|||||||ANCOM-BC2|||Haemophilus haemolyticus: Change From Baseline at Week 6||||0.01955327
71915625|NCT06048809|143352352|OTHER|||||||0.01995277|||||||ANCOM-BC2|||Neisseria mucosa: Change From Baseline at Week 6||||0.01995277
71915626|NCT06048809|143352352|OTHER|||||||0.02082528|||||||ANCOM-BC2|||Parvimonas sp.\_HMT\_393\_nov\_97.053%: Change From Baseline at Week 6||||0.02082528
71683692|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
71683693|NCT02440854|142885707|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||<0.001
71915627|NCT06048809|143352352|OTHER|||||||0.02188156|||||||ANCOM-BC2|||Ottowia sp.\_HMT\_894: Change from Baseline at Week 6||||0.02188156
71915628|NCT06048809|143352352|OTHER|||||||0.02321733|||||||ANCOM-BC2|||Cryptobacterium curtum: Change From Baseline at Week 6||||0.02321733
71915629|NCT06048809|143352352|OTHER|||||||0.02397996|||||||ANCOM-BC2|||Lautropia mirabilis: Change from Baseline at Week 6||||0.02397996
71915630|NCT06048809|143352352|OTHER|||||||0.02509094|||||||ANCOM-BC2|||Haemophilus paraphrohaemolyticus: Change From Baseline at Week 6||||0.02509094
71915631|NCT06048809|143352352|OTHER|||||||0.02648847|||||||ANCOM-BC2|||Capnocytophaga sp.\_HMT\_332: Change From Baseline at Week 6||||0.02648847
71915632|NCT06048809|143352352|OTHER|||||||0.02828764|||||||ANCOM-BC2|||Neisseria flavescens: Change From Baseline at Week 6||||0.02828764
71683694|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71683695|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71683696|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||<0.001
71683697|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||<0.001
71873663|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.36||0.19|TWO_SIDED|90.0|-0.92|0.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.28|-0.92|0.190
71873664|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.35||0.467|TWO_SIDED|90.0|-0.6|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-0.60|0.467
71915633|NCT06048809|143352352|OTHER|||||||0.03454372|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_96.429%: Change From Baseline at Week 6||||0.03454372
71915634|NCT06048809|143352352|OTHER|||||||0.03747507|||||||ANCOM-BC2|||Capnocytophaga sputigena: Change From Baseline at Week 6||||0.03747507
71915635|NCT06048809|143352352|OTHER|||||||0.03776136|||||||ANCOM-BC2|||Haemophilus sputorum: Change From Baseline at Week 6||||0.03776136
71915636|NCT06048809|143352352|OTHER|||||||0.03853215|||||||ANCOM-BC2|||Capnocytophaga gingivalis\_nov\_90.546%: Change From Baseline at Week 6||||0.03853215
71915637|NCT06048809|143352352|OTHER|||||||0.04751303|||||||ANCOM-BC2|||Prevotella denticola: Change From Baseline at Week 6||||0.04751303
71915638|NCT06048809|143352352|OTHER|||||||0.05190512|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_513: Change From Baseline at Week 6||||0.05190512
71915639|NCT06048809|143352352|OTHER|||||||0.0550647|||||||ANCOM-BC2|||Veillonella sp.\_HMT\_780: Change From Baseline at Week 6||||0.0550647
71915640|NCT06048809|143352352|OTHER|||||||0.05861488|||||||ANCOM-BC2|||Neisseria perflava: Change From Baseline at Week 6||||0.05861488
71915641|NCT06048809|143352352|OTHER|||||||0.06727926|||||||ANCOM-BC2|||Slackia exigua: Change From Baseline at Week 6||||0.06727926
71683698|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||<0.001
71683699|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683700|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||<0.001
71683701|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||<0.001
71683702|NCT02440854|142885708|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||<0.001
71683703|NCT02440854|142885708|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.002
71683704|NCT02440854|142885709|OTHER|||||||0.022|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.022
71683705|NCT02440854|142885709|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||<0.001
71683706|NCT02440854|142885709|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.004
71683707|NCT02440854|142885709|OTHER|||||||0.032|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.032
71683708|NCT02440854|142885709|OTHER|||||||0.066|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.066
71683709|NCT02440854|142885709|OTHER|||||||0.042|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.042
71915642|NCT06048809|143352352|OTHER|||||||0.07051698|||||||ANCOM-BC2|||Shuttleworthia satelles: Change from Baseline at Week 6||||0.07051698
71915643|NCT06048809|143352352|OTHER|||||||0.0740793|||||||ANCOM-BC2|||Aggregatibacter sp.\_HMT\_458: Change From Baseline at Week 6||||0.0740793
71915644|NCT06048809|143352352|OTHER|||||||0.07426973|||||||ANCOM-BC2|||Ruminococcaceae\_\[G-1\] bacterium\_HMT\_075: Change From Baseline at Week 6||||0.07426973
71915645|NCT06048809|143352352|OTHER|||||||0.07829888|||||||ANCOM-BC2|||Campylobacter showae: Change From Baseline at Week 6||||0.07829888
71915646|NCT06048809|143352352|OTHER|||||||0.08462924|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_056: Change From Baseline at Week 6||||0.08462924
71915647|NCT06048809|143352353|OTHER|||||||0.062378|||||||ANCOM-BC2|||Abiotrophia defectiva: Change from Baseline at Week 6||||0.062378
71915648|NCT06048809|143352353|OTHER|||||||0.063437|||||||ANCOM-BC2|||Saccharibacteria\_(TM7)\_\[G1\] bacterium\_HMT\_346: Change from Baseline at Week 6||||0.063437
71915649|NCT06048809|143352353|OTHER|||||||0.069908|||||||ANCOM-BC2|||Olsenella sp.\_HMT\_807: Change from Baseline at Week 6||||0.069908
71915650|NCT06048809|143352353|OTHER|||||||0.079736|||||||ANCOM-BC2|||Fusobacterium nucleatum\_nucleatum\_subsp.\_animalis: Change from Baseline at Week 6||||0.079736
71915651|NCT06048809|143352353|OTHER|||||||0.094642|||||||ANCOM-BC2|||Bergeyella sp.\_HMT\_322: Change from Baseline at Week 6||||0.094642
71915652|NCT06048809|143352353|OTHER|||||||0.095848|||||||ANCOM-BC2|||Peptostreptococcaceae\_\[XI\]\[G-1\] \[Eubacterium\]\_infirmum: Change from Baseline at Week 6||||0.095848
71915653|NCT06048809|143352353|OTHER|||||||0.107931|||||||ANCOM-BC2|||Prevotella sp.\_HMT\_317: Change from Baseline at Week 6||||0.107931
71915654|NCT06048809|143352353|OTHER|||||||0.109114|||||||ANCOM-BC2|||Bacteroidales\_\[G-2\] bacterium\_HMT\_274: Change from Baseline at Week 6||||0.109114
71915655|NCT06048809|143352353|OTHER|||||||0.11083|||||||ANCOM-BC2|||Actinomyces sp.\_HMT\_175\_nov 97.951%: Change from Baseline at Week 6||||0.11083
71915656|NCT06048809|143352353|OTHER|||||||0.120377|||||||ANCOM-BC2|||Slackia exigua: Change from Baseline at Week 6||||0.120377
71915657|NCT06048809|143352353|OTHER|||||||0.123758|||||||ANCOM-BC2|||Granulicatella adiacens: Change from Baseline at Week 6||||0.123758
71683710|NCT02440854|142885709|OTHER|||||||0.045|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.045
71683711|NCT02440854|142885709|OTHER|||||||0.014|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.014
71683712|NCT02440854|142885709|OTHER|||||||0.015|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.015
71873665|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.35||0.153|TWO_SIDED|90.0|-0.94|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 1 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-0.94|0.153
71873666|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.41||0.632|TWO_SIDED|90.0|-0.54|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.54|0.632
71873667|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.41||0.094|TWO_SIDED|90.0|-1.22|0.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.14|-1.22|0.094
71873668|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.39||0.468|TWO_SIDED|90.0|-0.68|0.61|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.61|-0.68|0.468
71873669|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.39||0.167|TWO_SIDED|90.0|-1.03|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.03|0.167
71873670|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.37||0.394|TWO_SIDED|90.0|-0.72|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-0.72|0.394
71873671|NCT00568321|143266101|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.38||0.138|TWO_SIDED|90.0|-1.04|0.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Weeks 5 to 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.21|-1.04|0.138
71873672|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.55||0.764|TWO_SIDED|90.0|-0.51|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.51|0.764
71873673|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.37|STANDARD_ERROR_OF_MEAN|0.55||0.75|TWO_SIDED|90.0|-0.54|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.54|0.750
71915658|NCT06048809|143352353|OTHER|||||||0.123992|||||||ANCOM-BC2|||Prevotella oris: Change from Baseline at Week 6||||0.123992
71915659|NCT06048809|143352353|OTHER|||||||0.133385|||||||ANCOM-BC2|||Streptococcus sp.\_HMT\_064: Change from Baseline at Week 6||||0.133385
71915660|NCT06048809|143352353|OTHER|||||||0.144598|||||||ANCOM-BC2|||Schaalia odontolyticus: Change from Baseline at Week 6||||0.144598
71915661|NCT06048809|143352353|OTHER|||||||0.147278|||||||ANCOM-BC2|||Mogibacterium diversum: Change from Baseline at Week 6||||0.147278
71683713|NCT02440854|142885709|OTHER|||||||0.462|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.462
71683714|NCT02440854|142885710|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||<0.001
71873674|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|0.45||0.734|TWO_SIDED|90.0|-0.46|1.03|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.03|-0.46|0.734
71873675|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.45||0.514|TWO_SIDED|90.0|-0.73|0.77|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.77|-0.73|0.514
71873676|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|1.37|STANDARD_ERROR_OF_MEAN|1.89||0.765|TWO_SIDED|90.0|-1.76|4.5|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.50|-1.76|0.765
71915662|NCT06048809|143352353|OTHER|||||||0.148674|||||||ANCOM-BC2|||Prevotella denticola: Change from Baseline at Week 6||||0.148674
71915663|NCT06048809|143352353|OTHER|||||||0.149722|||||||ANCOM-BC2|||Absconditabacteria\_(SR1)\_\[G-1\] bacterium\_HMT\_875: Change from Baseline at Week 6||||0.149722
71915664|NCT06048809|143352353|OTHER|||||||0.154465|||||||ANCOM-BC2|||Prevotella nigrescens: Change from Baseline at Week 6||||0.154465
71915665|NCT06048809|143352353|OTHER|||||||0.158139|||||||ANCOM-BC2|||Streptococcus chosunense: Change from Baseline at Week 6||||0.158139
71915666|NCT00628134|143352356|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.07
71915667|NCT00628134|143352357|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons||||0.29
71683715|NCT02440854|142885710|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.004
71683716|NCT02440854|142885710|OTHER|||||||0.008|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.008
71915668|NCT03687827|143352358|SUPERIORITY|Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero.|Estimated treatment difference|1.43||||0.0321|TWO_SIDED|95.0|0.12|2.74|||t-test, 2 sided|||||2.74|0.12|0.0321
71915669|NCT03687827|143352358|NON_INFERIORITY|A non-inferiority margin of -0.83% has been applied, corresponding to 0.2 hours/24 hours|Estimated treatment difference|1.43|||||TWO_SIDED|95.0|0.12|2.74||||||||2.74|0.12|
71915670|NCT01957085|143352365|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.04||||||Statistical significance was set at .05 to determine statistical significance.|Chi-squared|||||||=.04
71915671|NCT01957085|143352366|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
71915672|NCT01957085|143352367|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
71915673|NCT01957085|143352369|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Chi-squared|||||||>.05
71915674|NCT03748420|143352373|SUPERIORITY||Odds Ratio (OR)|1.29|STANDARD_ERROR_OF_MEAN|0.09845||0.0103|TWO_SIDED|95.0|1.06|1.56|||Regression, Logistic|||||1.56|1.06|0.0103
71915675|NCT03748420|143352374|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.1166||0.7967|TWO_SIDED|95.0|0.82|1.3|||Regression, Logistic|||||1.30|0.82|0.7967
71915676|NCT03748420|143352375|SUPERIORITY||Odds Ratio (OR)|1.18|STANDARD_ERROR_OF_MEAN|0.08906||0.0589|TWO_SIDED|95.0|0.99|1.41|||Regression, Logistic|||||1.41|0.99|0.0589
71915677|NCT03748420|143352376|SUPERIORITY||Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.0871||0.21|TWO_SIDED|95.0|-0.8|3.5|||Mixed Models Analysis|||||3.5|-0.8|0.21
71915678|NCT03748420|143352377|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.1234||0.2|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.20
71683717|NCT02440854|142885710|OTHER|||||||0.315|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.315
71683718|NCT02440854|142885710|OTHER|||||||0.237|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.237
71683719|NCT02440854|142885710|OTHER||||||<|0.001|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||<0.001
71683720|NCT02440854|142885710|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.002
71683721|NCT02440854|142885710|OTHER|||||||0.004|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.004
71683722|NCT02440854|142885710|OTHER|||||||0.01|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.010
71683723|NCT02440854|142885710|OTHER|||||||0.683|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.683
71915679|NCT03748420|143352378|SUPERIORITY||Mean Difference (Net)|-7.47|STANDARD_ERROR_OF_MEAN|59.96||0.901|TWO_SIDED|95.0|-124.99|110.04|||Mixed Models Analysis|||||110.04|-124.99|0.901
71915680|NCT01925014|143352379|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.013|||||TWO_SIDED|95.0|-0.008|0.033|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.033|-0.008|
71915681|NCT01925014|143352380|NON_INFERIORITY|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.035|||||TWO_SIDED|95.0|-0.021|0.091|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.||0.091|-0.021|
71915682|NCT03489850|143352401|SUPERIORITY||Parameter Estimate|0.34|STANDARD_ERROR_OF_MEAN|0.69||0.62|TWO_SIDED|95.0|-1.01|1.69|||Generalized Estimating Equation|||||1.69|-1.01|.62
71915683|NCT03489850|143352402|SUPERIORITY||Odds Ratio (OR)|0.55|||<|0.05|TWO_SIDED|95.0|0.3|0.98|||Generalized Estimating Equation|||||.98|.30|<0.05
71915684|NCT03489850|143352403|SUPERIORITY||Odds Ratio (OR)|0.83|||<|0.05|TWO_SIDED|95.0|0.47|1.48|||Generalized Estimating Equation|||||1.48|0.47|<0.05
71915685|NCT03489850|143352404|SUPERIORITY||F|7.36|||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
71915686|NCT01302691|143352405|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-1.1||||0.205|TWO_SIDED|95.0|-2.7|0.6|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||0.6|-2.7|0.205
71915687|NCT01302691|143352411|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-3.2||||0.011|TWO_SIDED|95.0|-5.7|-0.8|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups||||-0.8|-5.7|0.011
71915688|NCT03934203|143352419|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 50 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|1.3|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|0.2|2.4|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||2.4|0.2|
71683724|NCT02440854|142885711|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 2-month post-baseline.||||0.062
71683725|NCT02440854|142885711|OTHER|||||||0.062|||||||t-test, 2 sided|Paired t-test.||Baseline vs 4-month post-baseline.||||0.062
71683726|NCT02440854|142885711|OTHER|||||||0.027|||||||t-test, 2 sided|Paired t-test.||Baseline vs 6-month post-baseline.||||0.027
71683727|NCT02440854|142885711|OTHER|||||||0.17|||||||t-test, 2 sided|Paired t-test.||Baseline vs 8-month post-baseline.||||0.170
71683728|NCT02440854|142885711|OTHER|||||||0.271|||||||t-test, 2 sided|Paired t-test.||Baseline vs 10-month post-baseline.||||0.271
71683729|NCT02440854|142885711|OTHER|||||||0.002|||||||t-test, 2 sided|Paired t-test.||Baseline vs 12-month post-baseline.||||0.002
71683730|NCT02440854|142885711|OTHER|||||||0.003|||||||t-test, 2 sided|Paired t-test.||Baseline vs 18-month post-baseline.||||0.003
71683731|NCT02440854|142885711|OTHER|||||||0.157|||||||t-test, 2 sided|Paired t-test.||Baseline vs 24-month post-baseline.||||0.157
71683732|NCT02440854|142885711|OTHER|||||||0.064|||||||t-test, 2 sided|Paired t-test.||Baseline vs 30-month post-baseline.||||0.064
71683733|NCT02440854|142885711|OTHER|||||||0.439|||||||t-test, 2 sided|Paired t-test||Baseline vs 36-month post-baseline.||||0.439
71683734|NCT02440854|142885712|OTHER|||||||0.388|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.388
71683735|NCT02440854|142885712|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.006
71915689|NCT03934203|143352420|OTHER|The null hypothesis was 'The mean difference in the QTcF changes from baseline between 250 mg BI 409306 and placebo is greater than or equal to 10 milliseconds at least for one timepoint after dosing.' The one-sided tests were performed at the 5% level; due to the symmetry of the normal distribution 2-sided 90% confidence intervals for the differences of adjusted means per timepoint were used.|Difference of adjusted means|5.7|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|4.4|7.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||7.1|4.4|
71683736|NCT02440854|142885712|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.077
71683737|NCT02440854|142885712|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
71683738|NCT02440854|142885712|OTHER|||||||0.508|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.508
71683739|NCT02440854|142885712|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
71683740|NCT02440854|142885712|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
71683741|NCT02440854|142885712|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
71683742|NCT02440854|142885712|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
71683743|NCT02440854|142885712|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
71683744|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||>0.999
71683745|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
71683746|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
71683747|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
71683748|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
71683749|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
71683750|NCT02440854|142885713|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
71683751|NCT02440854|142885714|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.774
71683752|NCT02440854|142885714|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||>0.999
71683753|NCT02440854|142885714|OTHER|||||||0.607|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.607
71683754|NCT02440854|142885714|OTHER|||||||0.774|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.774
71683755|NCT02440854|142885714|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||>0.999
71873677|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|1.9||0.646|TWO_SIDED|90.0|-2.43|3.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.86|-2.43|0.646
71873678|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.55||0.895|TWO_SIDED|90.0|-0.22|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.22|0.895
71873679|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.56||0.776|TWO_SIDED|90.0|-0.5|1.34|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.34|-0.50|0.776
71873680|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|0.45||0.944|TWO_SIDED|90.0|-0.03|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.03|0.944
71873681|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.46||0.835|TWO_SIDED|90.0|-0.31|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.31|0.835
71915690|NCT03934203|143352421|OTHER|No formal hypotheses were tested.|Difference of adjusted means|12.1|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|90.0|10.5|13.6|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as moxifloxacin - placebo at 1 hour and 30 minutes after drug intake.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.6|10.5|
71915691|NCT03934203|143352422|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 2 hours after drug administration.'|Difference of adjusted means|11.9|STANDARD_ERROR_OF_MEAN|0.9||0|TWO_SIDED|90.0|10.4|13.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0167.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||13.4|10.4|0.00000000
71915692|NCT03934203|143352423|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 3 hours after drug administration.'|Difference of adjusted means|11.1|STANDARD_ERROR_OF_MEAN|1.0||3e-08|TWO_SIDED|90.0|9.3|12.8||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.0250.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|9.3|0.00000003
71683756|NCT02440854|142885714|OTHER|||||||0.453|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.453
71683757|NCT02440854|142885714|OTHER|||||||0.688|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.688
71873682|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|3.23|STANDARD_ERROR_OF_MEAN|1.9||0.955|TWO_SIDED|90.0|0.09|6.37|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||6.37|0.09|0.955
71873683|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|2.31|STANDARD_ERROR_OF_MEAN|1.93||0.884|TWO_SIDED|90.0|-0.88|5.49|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.49|-0.88|0.884
71873684|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|0.56||0.737|TWO_SIDED|90.0|-0.57|1.28|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.28|-0.57|0.737
71873685|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.56||0.628|TWO_SIDED|90.0|-0.74|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.74|0.628
71873686|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.67|STANDARD_ERROR_OF_MEAN|0.46||0.925|TWO_SIDED|90.0|-0.1|1.43|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.43|-0.10|0.925
71873687|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.46||0.518|TWO_SIDED|90.0|-0.75|0.79|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.79|-0.75|0.518
71873688|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|1.93||0.81|TWO_SIDED|90.0|-1.49|4.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.88|-1.49|0.810
71873689|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.49|STANDARD_ERROR_OF_MEAN|1.94||0.6|TWO_SIDED|90.0|-2.72|3.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.70|-2.72|0.600
71873690|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.58||0.651|TWO_SIDED|90.0|-0.73|1.18|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.18|-0.73|0.651
71873691|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.59||0.342|TWO_SIDED|90.0|-1.21|0.73|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.73|-1.21|0.342
71873692|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.768|TWO_SIDED|90.0|-0.44|1.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.14|-0.44|0.768
71873693|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.48||0.211|TWO_SIDED|90.0|-1.19|0.41|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.41|-1.19|0.211
71873694|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.56|STANDARD_ERROR_OF_MEAN|1.99||0.61|TWO_SIDED|90.0|-2.73|3.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.85|-2.73|0.610
71873695|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|2.02||0.241|TWO_SIDED|90.0|-4.76|1.91|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.91|-4.76|0.241
71873696|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.59||0.789|TWO_SIDED|90.0|-0.5|1.45|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.45|-0.50|0.789
71873697|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.6||0.57|TWO_SIDED|90.0|-0.88|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.88|0.570
71683758|NCT02440854|142885714|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
71683759|NCT02440854|142885714|OTHER|||||||0.25|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||0.250
71683760|NCT02440854|142885714|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
71683761|NCT02440854|142885715|OTHER|||||||0.077|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.077
71873698|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.38|STANDARD_ERROR_OF_MEAN|0.49||0.782|TWO_SIDED|90.0|-0.43|1.19|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.19|-0.43|0.782
71683762|NCT02440854|142885715|OTHER||||||<|0.001|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||<0.001
71873699|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.49||0.295|TWO_SIDED|90.0|-1.08|0.55|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.55|-1.08|0.295
71873700|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|1.75|STANDARD_ERROR_OF_MEAN|2.04||0.804|TWO_SIDED|90.0|-1.62|5.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||5.11|-1.62|0.804
71873701|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|2.06||0.655|TWO_SIDED|90.0|-2.58|4.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||4.22|-2.58|0.655
71873702|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.6||0.409|TWO_SIDED|90.0|-1.13|0.86|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.86|-1.13|0.409
71873703|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.61||0.482|TWO_SIDED|90.0|-1.03|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-1.03|0.482
71873704|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.5||0.592|TWO_SIDED|90.0|-0.71|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.71|0.592
71873705|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.5||0.368|TWO_SIDED|90.0|-1.0|0.66|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.66|-1.00|0.368
71873706|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|2.08||0.396|TWO_SIDED|90.0|-3.98|2.88|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.88|-3.98|0.396
71683763|NCT02440854|142885715|OTHER|||||||0.006|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||0.006
71683764|NCT02440854|142885715|OTHER|||||||0.344|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||0.344
71683765|NCT02440854|142885715|OTHER|||||||0.146|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.146
71683766|NCT02440854|142885715|OTHER|||||||0.18|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||0.180
71683767|NCT02440854|142885715|OTHER|||||||0.289|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||0.289
71683768|NCT02440854|142885715|OTHER|||||||0.125|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||0.125
71683769|NCT02440854|142885715|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
71683770|NCT02440854|142885715|OTHER|||||||0.5|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||0.500
71683771|NCT02440854|142885716|OTHER|||||||0.21|||||||McNemar|||Shift in patient distribution between baseline and Month 2 post-baseline, according to problems/no problems.||||0.210
71683772|NCT02440854|142885716|OTHER|||||||0.263|||||||McNemar|||Shift in patient distribution between baseline and Month 4 post-baseline, according to problems/no problems.||||0.263
71683773|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 6 post-baseline, according to problems/no problems.||||>0.999
71873707|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|2.09||0.545|TWO_SIDED|90.0|-3.21|3.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.69|-3.21|0.545
71873708|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.62||0.486|TWO_SIDED|90.0|-1.04|1.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.00|-1.04|0.486
71873709|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.63||0.324|TWO_SIDED|90.0|-1.33|0.75|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Worst pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.75|-1.33|0.324
71873710|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.51||0.563|TWO_SIDED|90.0|-0.76|0.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.92|-0.76|0.563
71873711|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.52||0.282|TWO_SIDED|90.0|-1.16|0.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Average pain): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.56|-1.16|0.282
71873712|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|2.12||0.409|TWO_SIDED|90.0|-3.99|3.01||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||3.01|-3.99|0.409
71873713|NCT00568321|143266102|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.293|TWO_SIDED|90.0|-4.76|2.39||P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.|Repeated Measures Model|||Week 16 (Pain severity): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.39|-4.76|0.293
71873714|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.5||0.343|TWO_SIDED|90.0|-1.03|0.62|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.62|-1.03|0.343
71873715|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.51||0.576|TWO_SIDED|90.0|-0.75|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-0.75|0.576
71873716|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.63||0.46|TWO_SIDED|90.0|-1.1|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.10|0.460
71873717|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.63||0.435|TWO_SIDED|90.0|-1.15|0.94|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.94|-1.15|0.435
71873718|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.56||0.104|TWO_SIDED|90.0|-1.62|0.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.22|-1.62|0.104
71873719|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.57||0.204|TWO_SIDED|90.0|-1.42|0.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.47|-1.42|0.204
71683774|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 8 post-baseline, according to problems/no problems.||||>0.999
71683775|NCT02440854|142885716|OTHER|||||||0.629|||||||McNemar|||Shift in patient distribution between baseline and Month 10 post-baseline, according to problems/no problems.||||0.629
71683776|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 12 post-baseline, according to problems/no problems.||||>0.999
71683777|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 18 post-baseline, according to problems/no problems.||||>0.999
71683778|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 24 post-baseline, according to problems/no problems.||||>0.999
71683779|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 30 post-baseline, according to problems/no problems.||||>0.999
71683780|NCT02440854|142885716|OTHER||||||>|0.999|||||||McNemar|||Shift in patient distribution between baseline and Month 36 post-baseline, according to problems/no problems.||||>0.999
71683781|NCT02440854|142885717|OTHER|||||||0.098|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 2-month post-baseline.||||0.098
71683782|NCT02440854|142885717|OTHER|||||||0.359|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 4-month post-baseline.||||0.359
71683783|NCT02440854|142885717|OTHER|||||||0.393|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 6-month post-baseline.||||0.393
71683784|NCT02440854|142885717|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 8-month post-baseline.||||0.055
71683785|NCT02440854|142885717|OTHER|||||||0.124|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 10-month post-baseline.||||0.124
71683786|NCT02440854|142885717|OTHER|||||||0.376|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 12-month post-baseline.||||0.376
71683787|NCT02440854|142885717|OTHER|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 18-month post-baseline.||||0.033
71683788|NCT02440854|142885717|OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 24-month post-baseline.||||0.048
71683789|NCT02440854|142885717|OTHER|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 30-month post-baseline.||||0.071
71683790|NCT02440854|142885717|OTHER|||||||0.848|||||||Wilcoxon (Mann-Whitney)|||Baseline vs 36-month post-baseline.||||0.848
71683791|NCT02669082|142885730|OTHER|||||||0.2955|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.2955
71683792|NCT02669082|142885731|OTHER|||||||0.1358|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1358
71915693|NCT03934203|143352424|OTHER|T-Test based on the results of the MMRM (fitted to the data for all timepoints). The null hypothesis was 'The mean difference in the QTcF changes from baseline between moxifloxacin and placebo is less than or equal to 5 milliseconds at 4 hours after drug administration.'|Difference of adjusted means|10.7|STANDARD_ERROR_OF_MEAN|1.1||2e-07|TWO_SIDED|90.0|8.9|12.4||The corresponding alpha-level according to Hochberg's adjustment for mulitplicity was 0.050.|Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Difference of adjusted means was calculated as moxifloxacin - placebo.|MMRM was fitted to the observations for moxifloxacin and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.4|8.9|0.00000020
71683793|NCT02669082|142885732|OTHER||Median|||||0.1706|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1706
71683794|NCT02669082|142885733|OTHER|||||||0.1969|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.1969
71683795|NCT02669082|142885734|OTHER|||||||0.0534|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0534
71683796|NCT02669082|142885735|OTHER|||||||0.4125|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.4125
71683797|NCT02669082|142885736|OTHER|||||||0.022|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0220
71683798|NCT02669082|142885737|OTHER|||||||0.042|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.0420
71683799|NCT02669082|142885738|OTHER|||||||0.8166|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.||||0.8166
71683800|NCT00135356|142885818|SUPERIORITY_OR_OTHER||Difference in Means|0.03||||0.48||95.0|-0.06|0.12||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||LOCF||0.12|-0.06|0.48
71683801|NCT00135356|142885818|SUPERIORITY_OR_OTHER||Difference in Means|0.07||||0.57||95.0|-0.07|12.0||P-value not adjusted for multiple testing. 2-sided 95% CI|t-test, 2 sided|||OC||12.0|-0.07|0.57
71683802|NCT00135356|142885819|SUPERIORITY_OR_OTHER||Difference in Means|0.02||||0.73||95.0|-0.1|0.14||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||LOCF||0.14|-0.10|0.73
71683803|NCT00135356|142885819|SUPERIORITY_OR_OTHER||Difference in Means|-0.01||||0.91||95.0|-0.14|0.13||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||OC||0.13|-0.14|0.91
71683804|NCT00135356|142885820|SUPERIORITY_OR_OTHER||Difference in Mean|5.2||||0.27||95.0|-3.9|15.1||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 VAT LOCF||15.1|-3.9|0.27
71683805|NCT00135356|142885820|SUPERIORITY_OR_OTHER||Difference in Mean|1.8||||0.68||95.0|-6.7|11.2||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||VAT, Week 96 LOCF||11.2|-6.7|0.68
71683806|NCT00135356|142885820|SUPERIORITY_OR_OTHER||Difference in Means|4.4||||0.14||95.0|-1.4|10.6||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Trunk Fat LOCF||10.6|-1.4|0.14
71683807|NCT00135356|142885820|SUPERIORITY_OR_OTHER||Difference in Means|5.3||||0.14||95.0|-1.7|12.9||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Trunk Fat LOCF||12.9|-1.7|0.14
71683808|NCT00135356|142885821|SUPERIORITY_OR_OTHER||Difference in Means|4.0||||0.16||95.0|-1.6|10.0||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||SAT, Week 48, LOCF||10.0|-1.6|0.16
71683809|NCT00135356|142885821|SUPERIORITY_OR_OTHER||Difference in Mean|6.8||||0.06||95.0|-0.2|14.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 SAT||14.2|-0.2|0.06
71683810|NCT00135356|142885821|SUPERIORITY_OR_OTHER||Difference in Means|4.6||||0.15||95.0|-1.7|11.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48, Limb Fat||11.4|-1.7|0.15
71683811|NCT00135356|142885821|SUPERIORITY_OR_OTHER||Difference in Means|5.7||||0.17||95.0|-2.3|14.4||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||Week 96, Limb Fat||14.4|-2.3|0.17
71683812|NCT00135356|142885822|SUPERIORITY_OR_OTHER||DIfference in Means|3.6||||0.19||95.0|-1.8|9.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 TAT||9.4|-1.8|0.19
71683813|NCT00135356|142885822|SUPERIORITY_OR_OTHER||DIfference in Means|4.3||||0.16||95.0|-1.7|10.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|Wilcoxon (Mann-Whitney)|||Week 96 TAT||10.7|-1.7|0.16
71683814|NCT00135356|142885822|SUPERIORITY_OR_OTHER||Difference in Means|5.0||||0.0385||95.0|0.3|9.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Total Body Fat||9.7|0.3|0.0385
71683815|NCT00135356|142885822|SUPERIORITY_OR_OTHER||Difference in Means|5.9||||0.1||95.0|-1.0|13.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Total Body Fat||13.2|-1.0|0.10
71873720|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.75|STANDARD_ERROR_OF_MEAN|0.5||0.931|TWO_SIDED|90.0|-0.08|1.58|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.58|-0.08|0.931
71873721|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.52||0.941|TWO_SIDED|90.0|-0.04|1.67|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.67|-0.04|0.941
71915694|NCT03934203|143352425|OTHER|No formal hypotheses were tested.|Difference of adjusted means|2.4|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|1.4|3.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 20 minutes after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||3.3|1.4|
71915695|NCT03934203|143352426|OTHER|No formal hypotheses were tested.|Difference of adjusted means|11.7|STANDARD_ERROR_OF_MEAN|0.7|||TWO_SIDED|90.0|10.6|12.8|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Maximum difference of adjusted means was calculated as BI 409306 - placebo at 40 minutes after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||12.8|10.6|
71915696|NCT03934203|143352427|OTHER|No formal hypotheses were tested.|Difference of adjusted means|-1.2|STANDARD_ERROR_OF_MEAN|0.6|||TWO_SIDED|90.0|-2.3|-0.1|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 24 hours after drug intake.|MMRM was fitted to observations for 50 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||-0.1|-2.3|
71683816|NCT00135356|142885834|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.3|3.72||||||||3.72|0.3|
71873722|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.63||0.936|TWO_SIDED|90.0|-0.08|2.01|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.01|-0.08|0.936
71873723|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|1.17|STANDARD_ERROR_OF_MEAN|0.64||0.965|TWO_SIDED|90.0|0.11|2.23|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.23|0.11|0.965
71873724|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.59|STANDARD_ERROR_OF_MEAN|0.56||0.855|TWO_SIDED|90.0|-0.33|1.51|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.51|-0.33|0.855
71873725|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.42|STANDARD_ERROR_OF_MEAN|0.58||0.765|TWO_SIDED|90.0|-0.54|1.38|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.38|-0.54|0.765
71873726|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.51||0.504|TWO_SIDED|90.0|-0.84|0.85|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.85|-0.84|0.504
71873727|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.52||0.643|TWO_SIDED|90.0|-0.67|1.06|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.06|-0.67|0.643
71873728|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.64||0.486|TWO_SIDED|90.0|-1.09|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-1.09|0.486
71873729|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.65||0.6|TWO_SIDED|90.0|-0.91|1.24|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.24|-0.91|0.600
71873730|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.57||0.418|TWO_SIDED|90.0|-1.05|0.82|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.82|-1.05|0.418
71873731|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.59||0.515|TWO_SIDED|90.0|-0.95|0.99|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.99|-0.95|0.515
71873732|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.53||0.456|TWO_SIDED|90.0|-0.93|0.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.81|-0.93|0.456
71873733|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.54||0.556|TWO_SIDED|90.0|-0.82|0.97|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.97|-0.82|0.556
71683817|NCT00253370|142885852|SUPERIORITY_OR_OTHER||proportion of participants|0.409||||0.0012|TWO_SIDED|90.0|0.284|0.544|||one-sample binomial test|||The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.||0.544|0.284|0.0012
71683818|NCT01211483|142885885|SUPERIORITY||Hazard Ratio (HR)|0.978|||||TWO_SIDED|95.0|0.674|1.42||||||||1.420|0.674|
71683819|NCT01211483|142885885|SUPERIORITY||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.523|1.131||||||||1.131|0.523|
71683820|NCT01211483|142885886|SUPERIORITY||Hazard Ratio (HR)|0.369||||0.0185|TWO_SIDED|95.0|0.161|0.846|||Cox proportional hazard|||||0.846|0.161|0.0185
71915697|NCT03934203|143352428|OTHER|No formal hypotheses were tested.|Difference of adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|90.0|-1.3|1.3|||Mixed Models Analysis|Restricted maximum likelihood estimation and Kenward-Roger method to adjust standard errors and estimate denominator degrees of freedom.|Minimum difference of adjusted means was calculated as BI 409306 - placebo at 12 hours after drug intake.|MMRM was fitted to observations for 250 mg BI 409306 and the 2 placebo periods. MMRM with covariates 'period baseline', 'participant baseline' (=arithmetic mean of respective period baselines), fixed categorical effects 'treatment', 'period', and 'time', interaction terms 'period baseline-by-time', 'participant baseline-by-time', 'treatment-by-time', and 'period-by-time', 'participant' (random effect), and time within period as repeated measures per participant (covariance matrix=Unstructured).||1.3|-1.3|
71915698|NCT00608842|143352474|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
71915699|NCT00608842|143352474|SUPERIORITY_OR_OTHER||Difference to placebo|0.0|||||TWO_SIDED|95.0|-18.4|20.4||||||Complete Clearance||20.4|-18.4|
71915700|NCT00608842|143352474|SUPERIORITY_OR_OTHER||Difference to placebo|7.1|||||TWO_SIDED|95.0|-12.2|31.5||||||Complete Clearance||31.5|-12.2|
71873734|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.67||0.448|TWO_SIDED|90.0|-1.19|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.19|0.448
71873735|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.68||0.6|TWO_SIDED|90.0|-0.95|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.95|0.600
71873736|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.59||0.225|TWO_SIDED|90.0|-1.41|0.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.52|-1.41|0.225
71873737|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.61||0.387|TWO_SIDED|90.0|-1.18|0.83|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.83|-1.18|0.387
71873738|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.54||0.657|TWO_SIDED|90.0|-0.67|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-0.67|0.657
71915701|NCT00608842|143352474|SUPERIORITY_OR_OTHER||Difference to placebo|1.6|||||TWO_SIDED|95.0|-23.0|27.5||||||≥ 75% Cleared||27.5|-23.0|
71915702|NCT00608842|143352474|SUPERIORITY_OR_OTHER||Difference to placebo|-5.1|||||TWO_SIDED|95.0|-28.3|19.6||||||≥ 75% Cleared||19.6|-28.3|
71683821|NCT01211483|142885886|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.0034|TWO_SIDED|95.0|0.125|0.663|||Cox proportional hazard|||||0.663|0.125|0.0034
71683822|NCT01211483|142885887|SUPERIORITY||Hazard Ratio (HR)|1.006||||0.9879|TWO_SIDED|95.0|0.458|2.212|||Cox proportional hazard|||||2.212|0.458|0.9879
71683823|NCT01211483|142885887|SUPERIORITY||Hazard Ratio (HR)|1.222||||0.6276|TWO_SIDED|95.0|0.544|2.746|||Cox proportional hazard|||||2.746|0.544|0.6276
71915703|NCT00608842|143352474|SUPERIORITY_OR_OTHER||Difference to placebo|2.5|||||TWO_SIDED|95.0|-22.3|29.5||||||≥ 75% Cleared||29.5|-22.3|
71915704|NCT03787095|143352484|SUPERIORITY|||||||0.71|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.71
71915705|NCT03787095|143352485|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||1.00
71915706|NCT03787095|143352486|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Null hypothesis: There is no change from baseline to post-baseline among participants treated with Cemiplimab. Per the analysis plan, only participants in the Cemiplimab arm are evaluated.||||0.33
71683824|NCT04245202|142885925|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71683825|NCT04245202|142885926|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71873739|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.55||0.808|TWO_SIDED|90.0|-0.43|1.4|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.40|-0.43|0.808
71873740|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.45|STANDARD_ERROR_OF_MEAN|0.68||0.742|TWO_SIDED|90.0|-0.68|1.57|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.57|-0.68|0.742
71873741|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|0.7||0.923|TWO_SIDED|90.0|-0.16|2.14|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.14|-0.16|0.923
71915707|NCT02092324|143352489|SUPERIORITY|1-proportion test for greater than 10% difference.||||||0.002||||||p-value for Protocol-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.002
71915708|NCT02092324|143352489|SUPERIORITY|1-proportion test for greater than 10% difference||||||0.9||||||p-value is for IWG-defined objective response|binomial|||Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate (based on Simon's 2-stage).||||0.90
71915709|NCT02092324|143352492|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.|||||<|0.0001||||||p-value for protocol-defined objective response. p-value for IWG-defined objective response is 0.70|Clopper-Pearson method|||||||<0.0001
71915710|NCT02092324|143352492|SUPERIORITY|Proportion estimated using Clopper-Pearson method. P-value is one-sided proportion test for greater than 10% response rate.||||||0.7||||||p-value for IWG-defined objective response|Clopper-Pearson method|||||||0.70
71915711|NCT02092324|143352502|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic)||||||0.003||||||p-value for protocol-defined objective response.|Chi-squared, Corrected|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for protocol-defined objective response||||0.003
71915712|NCT02092324|143352502|EQUIVALENCE|2-sample test for equality of proportions with continuity correction (Pearson's chi-square)||||||0.1||||||p-value for IWG-defined objective response = 0.1|Fisher Exact|||2-sample test for equality of proportions with continuity correction (Pearson's chi-square test statistic) comparing Wildtype and Mutant CSF3R status for IWG-defined objective response||||0.1
71915713|NCT00441012|143352543|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|100.0||||||95.0|98.7|100.0|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||100.0|98.7|
71915714|NCT00441012|143352543|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|99.1||||||95.0|69.9|99.9|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs \>=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.||99.9|69.9|
71915715|NCT00441012|143352544|NON_INFERIORITY_OR_EQUIVALENCE|The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs \[GMT modified process vaccine/GMT COMVAX™\] is \>0.67.|Geometric Mean Titer Ratio|2.5||||||95.0|1.9|3.3||||||||3.3|1.9|
71915716|NCT00441012|143352546|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|93.9||||||95.0|90.0|96.6|||||Exact binomial confidence interval|||96.6|90.0|
71915717|NCT00441012|143352546|SUPERIORITY_OR_OTHER||Percentage of Seroprotected Participants|92.1||||||95.0|87.8|95.3|||||Exact binomial confidence interval|No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of participants with anti-PRP \> 1µg/mL) in each group at 1 month after the third dose.||95.3|87.8|
71915718|NCT01838304|143352571|OTHER||Odds Ratio (OR)|7.9|||<|0.0001|TWO_SIDED|95.0|4.21|14.81|||Fisher Exact|||Fisher's exact test for odd's ratio of time below a saturation of 80% to total time||14.81|4.21|<0.0001
71915719|NCT03674541|143352574|SUPERIORITY|||||||0.043|||||||Welch's t-test|||||||0.043
71915720|NCT03674541|143352575|SUPERIORITY|||||||0.008||||||P-value was not adjusted for multiplicity for secondary outcomes|Welch's t-test|||||||0.008
71915721|NCT03674541|143352576|SUPERIORITY|||||||0.263||||||Not adjusted for multiplicity|Welch's t-test|||||||0.263
71915722|NCT03674541|143352577|SUPERIORITY|||||||0.039||||||Not adjusted for multiplicity|Welch's t-test|||||||0.039
71915723|NCT03674541|143352578|SUPERIORITY|||||||0.068||||||Not adjusted for multiplicity|Welch's t-test|||||||0.068
71915724|NCT03674541|143352579|SUPERIORITY|||||||0.045||||||Not adjusted for multiplicity|Welch's t-test|||||||0.045
71915725|NCT03674541|143352580|SUPERIORITY|||||||1||||||Not adjusted multiplicity|Welch's t-test|||||||1.000
71915726|NCT03674541|143352581|SUPERIORITY|||||||0.093||||||Not adjusted for multiplicity|Welch's t-test|||||||0.093
71873742|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.6||0.49|TWO_SIDED|90.0|-1.01|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-1.01|0.490
71873743|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.62||0.609|TWO_SIDED|90.0|-0.86|1.2|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.20|-0.86|0.609
71873744|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.55||0.362|TWO_SIDED|90.0|-1.1|0.71|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.71|-1.10|0.362
71873745|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.16|STANDARD_ERROR_OF_MEAN|0.56||0.61|TWO_SIDED|90.0|-0.77|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.77|0.610
71873746|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.7||0.376|TWO_SIDED|90.0|-1.37|0.93|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.93|-1.37|0.376
71873747|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.71||0.733|TWO_SIDED|90.0|-0.73|1.6|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.60|-0.73|0.733
71873748|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.61||0.303|TWO_SIDED|90.0|-1.33|0.69|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.69|-1.33|0.303
71873749|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.63||0.548|TWO_SIDED|90.0|-0.97|1.12|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.12|-0.97|0.548
71873750|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.56||0.609|TWO_SIDED|90.0|-0.77|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-0.77|0.609
71873751|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.13|STANDARD_ERROR_OF_MEAN|0.59||0.59|TWO_SIDED|90.0|-0.83|1.1|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (CS): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.10|-0.83|0.590
71873752|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.71||0.556|TWO_SIDED|90.0|-1.07|1.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.27|-1.07|0.556
71873753|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.73||0.443|TWO_SIDED|90.0|-1.32|1.11|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (GA): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.11|-1.32|0.443
71915727|NCT03674541|143352582|SUPERIORITY|||||||0.427||||||Not adjusted for multiplicity|Welch's t-test|||||||0.427
71915728|NCT03674541|143352583|SUPERIORITY|||||||0.262||||||Not adjusted for multiplicity|Welch's t-test|||||||0.262
71915729|NCT03674541|143352584|SUPERIORITY|||||||0.038||||||Not adjusted for multiplicity|Welch's t-test|||||||0.038
71683826|NCT04245202|142885927|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71915730|NCT03674541|143352585|SUPERIORITY|||||||0.147|||||||Welch's t-test|||||||0.147
71915731|NCT00117572|143352641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.68|TWO_SIDED|95.0|0.59|1.41|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|Comparison of overall survival curves||1.41|0.59|0.68
71915732|NCT00117572|143352642|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.55|1.25|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.25|0.55|0.37
71915733|NCT00117572|143352643|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.16|TWO_SIDED|95.0|0.51|1.12|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|||1.12|0.51|0.16
71915734|NCT00117572|143352644|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher Exact|||||||0.57
71915735|NCT00117572|143352645|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher Exact|||||||0.11
71915736|NCT00117572|143352646|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|Comparison of change scores between treatment groups||||||0.55
71915737|NCT00117572|143352647|SUPERIORITY_OR_OTHER|||||||0.034|||||||t-test, 2 sided|||||||0.034
71915738|NCT00117572|143352648|SUPERIORITY_OR_OTHER|||||||0.35|||||||t-test, 2 sided|||||||0.35
71915739|NCT00117572|143352649|SUPERIORITY_OR_OTHER|||||||0.96|||||||t-test, 2 sided|||||||0.96
71683827|NCT04245202|142885928|OTHER||Mean Difference (Net)|-12.29|STANDARD_DEVIATION|5.72|<|0.001|TWO_SIDED|95.0|-23.53|-1.05||The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||-1.05|-23.53|<0.001
71683828|NCT04245202|142885929|OTHER||Mean Difference (Net)|-12.66|STANDARD_DEVIATION|4.77|<|0.001|TWO_SIDED|95.0|-22.05|-3.28|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analyses, p values \<0·05 were considered being statistically significant.||-3.28|-22.05|<0.001
71683829|NCT04245202|142885930|OTHER||Mean Difference (Net)|-3.91|STANDARD_DEVIATION|2.43|<|0.001|TWO_SIDED|95.0|-8.68|0.86||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||0.86|-8.68|<0.001
71873754|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.62||0.527|TWO_SIDED|90.0|-0.99|1.07|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.07|-0.99|0.527
71873755|NCT00568321|143266109|SUPERIORITY||LS Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.66||0.583|TWO_SIDED|90.0|-0.95|1.22|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (NW): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.22|-0.95|0.583
71873756|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.63||0.111|TWO_SIDED|90.0|-1.81|0.27|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.27|-1.81|0.111
71873757|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.64||0.523|TWO_SIDED|90.0|-1.02|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 1: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.02|0.523
71873758|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|0.77|STANDARD_ERROR_OF_MEAN|0.63||0.887|TWO_SIDED|90.0|-0.28|1.81|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.81|-0.28|0.887
71873759|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|0.85|STANDARD_ERROR_OF_MEAN|0.65||0.903|TWO_SIDED|90.0|-0.23|1.92|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.92|-0.23|0.903
71873760|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.64||0.472|TWO_SIDED|90.0|-1.11|1.02|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.02|-1.11|0.472
71873761|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|0.22|STANDARD_ERROR_OF_MEAN|0.66||0.628|TWO_SIDED|90.0|-0.87|1.3|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 4: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.30|-0.87|0.628
71873762|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.67||0.243|TWO_SIDED|90.0|-1.58|0.64|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.64|-1.58|0.243
71873763|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.69||0.346|TWO_SIDED|90.0|-1.42|0.87|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.87|-1.42|0.346
71873764|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.69||0.467|TWO_SIDED|90.0|-1.19|1.08|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.08|-1.19|0.467
71873765|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.7||0.67|TWO_SIDED|90.0|-0.85|1.47|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 8: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.47|-0.85|0.670
71683830|NCT04245202|142885931|OTHER||Mean Difference (Net)|-2.41|STANDARD_DEVIATION|2.14||0.003|TWO_SIDED|95.0|-6.62|1.78|||Mixed Models Analysis||Treatment difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.||1.78|-6.62|0.003
71683831|NCT04245202|142885932|OTHER||Relative treatment effect difference|-0.07||||0.002|TWO_SIDED|||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.002
71873766|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.7||0.286|TWO_SIDED|90.0|-1.55|0.76|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.76|-1.55|0.286
71683832|NCT04245202|142885933|OTHER||Relative treatment effect difference|-0.08||||0.001|TWO_SIDED|95.0||||The p-Value of the interaction between time and groups was given. In all analysis, p values \<0.05 were considered being statistically significant.|Brunner-Langer Method||Relative Treatment Effect Difference= High-Flow Nasal Cannula Oxygen Therapy (96-0 h) - Standard Face Mask Oxygen Therapy (96-0 h) (based on least-square means)|||||0.001
71683833|NCT04245202|142885935|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71683834|NCT04245202|142885936|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71683835|NCT04245202|142885937|OTHER|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||||||0.99
71683836|NCT04245202|142885938|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71873767|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.71||0.598|TWO_SIDED|90.0|-1.0|1.35|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.35|-1.00|0.598
71873768|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.453|TWO_SIDED|90.0|-1.26|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-1.26|0.453
71873769|NCT00568321|143266112|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.74||0.472|TWO_SIDED|90.0|-1.28|1.17|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16: LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.17|-1.28|0.472
71683837|NCT04245202|142885939|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71683838|NCT04245202|142885940|OTHER|||||||0.08|||||||Fisher Exact|||||||0.08
71873770|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|1.02||0.548|TWO_SIDED|90.0|-1.81|1.56|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.56|-1.81|0.548
71873771|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.04||0.117|TWO_SIDED|90.0|-0.48|2.96|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.96|-0.48|0.117
71873772|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|-0.86|STANDARD_ERROR_OF_MEAN|1.11||0.779|TWO_SIDED|90.0|-2.69|0.98|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.98|-2.69|0.779
71873773|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.36|STANDARD_ERROR_OF_MEAN|1.14||0.375|TWO_SIDED|90.0|-1.52|2.25|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.25|-1.52|0.375
71873774|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|-1.36|STANDARD_ERROR_OF_MEAN|1.15||0.881|TWO_SIDED|90.0|-3.26|0.54|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.54|-3.26|0.881
71873775|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|1.17||0.636|TWO_SIDED|90.0|-2.33|1.52|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.52|-2.33|0.636
71915740|NCT00117572|143352650|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71915741|NCT00117572|143352651|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED||||||t-test, 2 sided|||||||0.83
71915742|NCT00117572|143352652|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||t-test, 2 sided|||||||0.49
71915743|NCT00117572|143352653|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.090
71915744|NCT04973085|143352659|OTHER|||||||0.02|||||||t-test, 2 sided|||||||0.02
71915745|NCT03028467|143352703|OTHER||Mean Difference (Net)|-1.111|||||TWO_SIDED|95.0|-2.7186|0.4965|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.4965|-2.7186|
71683839|NCT02470403|142885941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-5.7|||<|0.001|TWO_SIDED|80.0|-6.52|-4.87|||Mixed Models Analysis|||"This analysis included all subjects. The following criteria were assessed:~1. upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-4.87|-6.52|<0.001
71915746|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.5177|||||TWO_SIDED|95.0|-1.904|0.8685|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8685|-1.9040|
71915747|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.5332|||||TWO_SIDED|95.0|-1.914|0.8475|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8475|-1.9140|
71915748|NCT03028467|143352703|OTHER||Mean Difference (Net)|-1.1387|||||TWO_SIDED|95.0|-2.8848|0.6075|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6075|-2.8848|
71915749|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.8905|||||TWO_SIDED|95.0|-2.3962|0.6153|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6153|-2.3962|
71915750|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.8047|||||TWO_SIDED|95.0|-2.3045|0.6951|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6951|-2.3045|
71915751|NCT03028467|143352703|OTHER||Mean Difference (Net)|-1.4575|||||TWO_SIDED|95.0|-3.6013|0.6863|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6863|-3.6013|
71915752|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.8894|||||TWO_SIDED|95.0|-2.7381|0.9593|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.9593|-2.7381|
71915753|NCT03028467|143352703|OTHER||Mean Difference (Net)|-1.1615|||||TWO_SIDED|95.0|-3.0028|0.6799|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.6799|-3.0028|
71915754|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.3209|||||TWO_SIDED|95.0|-2.3021|1.6603|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.6603|-2.3021|
71915755|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.1876|||||TWO_SIDED|95.0|-1.896|1.5209|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5209|-1.8960|
71915756|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.4593|||||TWO_SIDED|95.0|-2.161|1.2424|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.2424|-2.1610|
71683840|NCT02470403|142885941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-6.85|||<|0.001|TWO_SIDED|80.0|-7.96|-5.73|||Mixed Models Analysis|||"This analysis included dysglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-5.73|-7.96|<0.001
71915757|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.6521|||||TWO_SIDED|95.0|-3.1342|1.83|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.8300|-3.1342|
71915758|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.5499|||||TWO_SIDED|95.0|-2.6903|1.5904|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.5904|-2.6903|
71915759|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.9665|||||TWO_SIDED|95.0|-3.0984|1.1654|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1654|-3.0984|
71915760|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.3576|||||TWO_SIDED|95.0|-3.0892|2.374|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.3740|-3.0892|
71915761|NCT03028467|143352703|OTHER||Mean Difference (Net)|0.1851|||||TWO_SIDED|95.0|-2.1704|2.5407|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.5407|-2.1704|
71915762|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.1181|||||TWO_SIDED|95.0|-2.4643|2.2281|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.2281|-2.4643|
71915763|NCT03028467|143352703|OTHER||Mean Difference (Net)|-1.4276|||||TWO_SIDED|95.0|-3.6569|0.8018|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||0.8018|-3.6569|
71915764|NCT03028467|143352703|OTHER||Mean Difference (Net)|0.5415|||||TWO_SIDED|95.0|-1.381|2.4639|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||2.4639|-1.3810|
71683841|NCT02470403|142885941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-4.55|||<|0.001|TWO_SIDED|80.0|-5.76|-3.34|||Mixed Models Analysis|||"This analysis included normoglycemic subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-3.34|-5.76|<0.001
71683842|NCT02470403|142885943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.83|||<|0.001|TWO_SIDED|80.0|-2.16|-1.51|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.51|-2.16|<0.001
71873776|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.17||0.905|TWO_SIDED|90.0|-3.46|0.39|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||0.39|-3.46|0.905
71873777|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.21||0.499|TWO_SIDED|90.0|-2.0|2.0|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Learning): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||2.00|-2.00|0.499
71873778|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.5||0.297|TWO_SIDED|90.0|-0.56|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.56|0.297
71683843|NCT02470403|142885943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.39|||<|0.001|TWO_SIDED|80.0|-2.94|-1.84|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."||-1.84|-2.94|<0.001
71683844|NCT02470403|142885943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-2.38|||<|0.001|TWO_SIDED|80.0|-2.93|-1.83|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~1. upper confidence limit of 80% CI for treatment difference was less than 0, and~2. estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%"||-1.83|-2.93|<0.001
71683845|NCT00904839|142885971|SUPERIORITY_OR_OTHER||Difference|-8.1|||||TWO_SIDED|95.0|-27.8|11.5|||Kaplan-Meier||Difference in Kaplan-Meier Progression-free Survival Rates at 9 Months using Peto´s variance estimate.|||11.5|-27.8|
71683846|NCT00904839|142885976|SUPERIORITY_OR_OTHER||Difference|-5.0|||||TWO_SIDED|95.0|-15.3|5.2|||Kaplan-Meier||confidence interval includes 0, meaning that the null hypothesis (no difference between the 2 groups) cannot be rejected (i.e. pvalue \> 0.05). The pvalue was not computed. Difference in Kaplan-Meier Resection Rates using Peto´s variance estimate.|||5.2|-15.3|
71683847|NCT01430624|142885987|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df 2, 109||||||.24
71683848|NCT01430624|142885988|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||6 month follow-up comparison|ANOVA|df = 2, 111||||||.89
71683849|NCT01430624|142885989|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.01
71683850|NCT01430624|142885989|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||3 month comparison|ANOVA|||||||.48
71873779|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.91|STANDARD_ERROR_OF_MEAN|0.5||0.035|TWO_SIDED|90.0|0.09|1.74|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 2 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.74|0.09|0.035
71873780|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.54||0.222|TWO_SIDED|90.0|-0.48|1.31|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.31|-0.48|0.222
71873781|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.81|STANDARD_ERROR_OF_MEAN|0.54||0.069|TWO_SIDED|90.0|-0.09|1.7|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 6 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.70|-0.09|0.069
71915765|NCT03028467|143352703|OTHER||Mean Difference (Net)|-0.7932|||||TWO_SIDED|95.0|-2.708|1.1217|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.|||1.1217|-2.7080|
71915766|NCT01387594|143352705|SUPERIORITY_OR_OTHER_LEGACY||Geometric Mean Ratio (GMR)|1.33|||||TWO_SIDED|80.0|1.13|1.56||A p-value was not computed; hypothesis was tested using confidence interval (CI) approach.|||The lower limit of 80% CI greater than 0.5 indicates the statistical significance at alpha=0.1 level.|The null hypothesis is the (median) percent decrease in total lymphocytes count is greater or equal to 50%, equivalently indicating that the geometric mean ratio (GMR: post-treatment/pretreatment) in total lymphocyte counts is less than or equal to 0.5.||1.56|1.13|
71683851|NCT01430624|142885989|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||6 month comparison|ANOVA|||||||.17
71683852|NCT01430624|142885990|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||6 week comparison|Chi-squared|df = 2, 154||||||.37
71683853|NCT01430624|142885990|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||3 month comparison|Chi-squared|df = 2, 135||||||.15
71683854|NCT01430624|142885990|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED|||||6 month comparison|Chi-squared|df = 2, 121||||||.87
71683855|NCT01430624|142885991|SUPERIORITY_OR_OTHER|||||||0.63|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 150||||||.63
71683856|NCT01430624|142885991|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.25
71683857|NCT01430624|142885991|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.59
71683858|NCT01430624|142885992|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.83
71683859|NCT01430624|142885992|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.29
71683860|NCT01430624|142885992|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 118||||||.13
71683861|NCT01430624|142885993|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 151||||||.012
71683862|NCT01430624|142885993|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 132||||||.31
71683863|NCT01430624|142885993|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED|||||6 month comparison|ANOVA|df = 2,116||||||.35
71683864|NCT01430624|142885994|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||6 week comparison|ANOVA|df = 2, 141||||||.15
71683865|NCT01430624|142885994|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||3 month comparison|ANOVA|df = 2, 127||||||.67
71683866|NCT01430624|142885994|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||6 month comparison|ANOVA|df = 2, 110||||||.40
71683867|NCT00553358|142886005|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|-4.85||||0.3416|TWO_SIDED|97.5|-17.6|8.16|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1500 mg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm1 (Lapatinib 1500 mg) minus Arm2 (Trastuzumab 2 mg/kg).|||8.16|-17.6|0.3416
71683868|NCT00553358|142886005|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants with pCR|21.79||||0.0001|TWO_SIDED|97.5|9.08|34.23|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg)|||34.23|9.08|0.0001
71683869|NCT00553358|142886013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.548|TWO_SIDED|95.0|0.57|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.57|0.548
71683870|NCT00553358|142886013|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.005||||0.981|TWO_SIDED|95.0|0.66|1.52||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.52|0.66|0.981
71873782|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|0.55||0.338|TWO_SIDED|90.0|-0.68|1.15|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.15|-0.68|0.338
71873783|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.56||0.381|TWO_SIDED|90.0|-0.75|1.09|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 12 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.09|-0.75|0.381
71915767|NCT03991468|143352729|NON_INFERIORITY|A Mixed Model Repeated Measures logistic regression was used to prove WSI major discordance (MD) rate non-inferior to Glass MD rate. A two-sided 95% CI for the difference in MD rate was constructed. If the upper bound of the 95% CI was less than the non-inferiority margin of 4%, then WSI would be considered non-inferior to Glass, assuming power = 0.9 and alpha = 0.05 a sample size of 2000 was calculated to be sufficient to prove non-inferiority.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|Dependent var = major discordance status (yes/no); independent var = modality (WSI/Glass) as a fixed effect \& site, reader, \& case as random effects.||||1.0|-0.1|
71915768|NCT03573804|143352731|OTHER|A two-tailed paired T-test for equivalence was used to evaluate equivalence between the average raw tumor.|Mean Difference (Net)|224.675|STANDARD_ERROR_OF_MEAN|67.89|<|0.001|TWO_SIDED|95.0|90.26044|359.08956||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine tumor intensity values.||Regions of interest (ROIs) for tumor were defined by the radiologist segmentation of tumor in supine and prone positions. ROIs for the surrounding tissue were selected such that tumor and normal regions had equal volumes. The alpha level was assumed to be of 0.05 (dof = 60), and the null hypothesis of equivalence (mu = 0).||359.08956|90.26044|<0.001
71915769|NCT03573804|143352732|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine mean benign tissue intensities.|Mean Difference (Net)|165.833|STANDARD_ERROR_OF_MEAN|44.19|<|0.001|TWO_SIDED|95.0|78.34708|253.31892||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A paired two-tailed t-test was used on the paired prone-to-supine normal tissue intensity values.||Regions of interest (ROIs) for surrounding tissues were selected as the surrounding benign tissue regions directly adjacent to the segmented tumor regions. Tumor and surrounding regions had equal volumes. The mean surrounding region intensities reported were all calculated from the prone and supine T1-weighted MR images segmented by the radiologist.||253.31892|78.34708|<0.001
71915770|NCT03573804|143352733|OTHER|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.|Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.08||0.0058|TWO_SIDED|95.0|-0.04209|0.28209||Using an alpha value of 0.05, dof = 60, the null hypothesis of sample mean equivalence was rejected.|t-test, 2 sided|A two-tailed paired T-test was used to compare sample means in between the prone and supine tumor-to-surrounding tissue ratios.||The ratios of tumor-to-surrounding tissue intensities, as calculated in Secondary Objective Part A, were compared between prone and supine T1-weighted MR image scans.||0.28209|-0.04209|0.0058
71915771|NCT03573804|143352735|SUPERIORITY|||||||0.00049664|||||||Students two-tailed paired t-test|||||||0.00049664
71915772|NCT01425307|143352736|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|We hypothesized that the Alternative arm mean TCD velocity at 24 months will be less than the Standard arm mean TCD velocity plus 15cm/sec. We used Lan-DeMets boundaries to control overall Type I error rate at α = 0.05. For looks at exactly 1/3, 2/3, and 100 percent of the completed subjects, the cumulative α were estimated to be 0.0001, 0.001, and 0.05, respectively.|Mean Difference (Final Values)|4.54|||<|0.05|TWO_SIDED|95.0|0.1|8.98||P value for non inferiority was 8.82 X 10\^-16|Mixed Models Analysis|Linear mixed model||Participants were randomized at a central site, stratified by site with a block size of four, and an adaptive randomization scheme was used to balance the covariates of baseline age and TCD velocity. The treatment period lasted 24 months. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population.||8.98|0.10|<0.05
71915773|NCT01425307|143352740|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71915774|NCT01425307|143352750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0011|||||||t-test, 2 sided|||||||0.0011
71915775|NCT04507360|143352756|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||"Mean difference in Overall row"||||
71915776|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|0.96|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71915777|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|0.63|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71915778|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|0.19|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71915779|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|0.62|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71915780|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|0.85|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71915781|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|0.41|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71915782|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|1.39|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71915783|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|2.16|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71915784|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|2.69|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71915785|NCT04507360|143352758|SUPERIORITY||Mean Difference (Final Values)|1.75|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71915786|NCT04507360|143352759|SUPERIORITY||Mean Difference (Final Values)|0.07|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71915787|NCT04507360|143352759|SUPERIORITY||Mean Difference (Final Values)|0.42|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71915788|NCT04507360|143352759|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71915789|NCT04507360|143352759|SUPERIORITY||Mean Difference (Final Values)|0.32|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71915790|NCT04507360|143352760|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71915791|NCT04507360|143352760|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71915792|NCT04507360|143352760|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71915793|NCT04507360|143352760|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71915794|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|0.58|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71915795|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71915796|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|1.24|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71915797|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71915798|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|0.03|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71915799|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|1.98|||||TWO_SIDED|||||||||Mean difference in total score at week 1||||
71915800|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|1.18|||||TWO_SIDED|||||||||Mean difference in total score at week 2||||
71915801|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|3.67|||||TWO_SIDED|||||||||Mean difference in total score at week 3||||
71915802|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|4.22|||||TWO_SIDED|||||||||Mean difference in total score at week 4||||
71915803|NCT04507360|143352761|SUPERIORITY||Mean Difference (Final Values)|2.07|||||TWO_SIDED|||||||||Mean difference in total score at week 8||||
71873784|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.56||0.306|TWO_SIDED|90.0|-0.64|1.21|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.21|-0.64|0.306
71873785|NCT00568321|143266126|SUPERIORITY||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.58||0.44|TWO_SIDED|90.0|-0.87|1.04|||Repeated Measures Model|P-value was based on repeated measures model from pairwise comparisons, and was 1-sided.||Week 16 (Delayed): LS Mean Difference was estimated from the repeated measures model with participant as random effect; treatment, week and treatment-by-week interaction as fixed effects and baseline as a covariate.||1.04|-0.87|0.440
71873786|NCT00221195|143266133|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||The Wilcoxin signed-rank test was used to compare the frequency of bleeds between the prophylaxis and on-demand periods.||||<0.001
71873787|NCT01106014|143266139|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.6|||<|0.0001|TWO_SIDED|99.0|0.46|0.78||one-sided p-value|Log Rank|||The primary analysis was performed on the Full Analysis Set by a one-sided unstratified log-rank test||0.78|0.46|<0.0001
71873788|NCT01106014|143266140|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|12.0||||0.0027|TWO_SIDED|99.0|1.0|24.0||One-sided p-value of the nonparametric ANCOVA, adjusted for 6-minute walk distance at baseline|ANCOVA||Point estimate and 2-sided 99% CI for location shift using the HodgesLehmann method|Non-parametric ANCOVA with 6MWD as covariate at baseline. Missing values were imputed based on the following imputation rules: 1) if patient was unable to walk at week 26, 0 meter was imputed, 2) if rule 1 did not apply, the second lowest observed 6MWD value (10 meters) at Week 26 was imputed. Missing values were imputed for 21.6% of the subjects.||24|1|0.0027
71873789|NCT01106014|143266141|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|It was assumed that the probabilities for absence of worsening in WHO FC at Week 26 were the same for both treatment groups|Odds Ratio, log|1.161||||0.2843|TWO_SIDED|99.0|0.811|1.664||Cochran-Mantel-Haenszel test stratified by WHO FC at baseline. For patients with missing NYHA/WHO FC at Week 26, the NYHA/WHO FC is considered as having worsened from baseline at Week 26. Missing values were imputed for 18.3% of subjects .|Cochran-Mantel-Haenszel|||||1.664|0.811|0.2843
71873790|NCT02260882|143266148|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
71915804|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|||||||||Mean difference at baseline||||
71915805|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.29|||||TWO_SIDED|||||||||Mean difference at week 1||||
71915806|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|||||||||Mean difference at week 2||||
71915807|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|||||||||Mean difference at week 3||||
71915808|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|1.68|||||TWO_SIDED|||||||||Mean difference at week 4||||
71873791|NCT02260882|143266148|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
71915809|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.16|||||TWO_SIDED|||||||||Mean difference at week 8||||
71915810|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.28|||||TWO_SIDED|||||||||Mean difference at baseline||||
71915811|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.67|||||TWO_SIDED|||||||||Mean difference at week 1||||
71915812|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.78|||||TWO_SIDED|||||||||Mean difference at week 2||||
71915813|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at week 3||||
71915814|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.47|||||TWO_SIDED|||||||||Mean difference at week 4||||
71915815|NCT04507360|143352764|SUPERIORITY||Mean Difference (Final Values)|0.24|||||TWO_SIDED|||||||||Mean difference at week 8||||
71915816|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.18|||||TWO_SIDED|||||||||Mean difference at baseline||||
71915817|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|||||||||Mean difference at week 1||||
71915818|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.23|||||TWO_SIDED|||||||||Mean difference at week 2||||
71915819|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.38|||||TWO_SIDED|||||||||Mean difference at week 3||||
71915820|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|1.26|||||TWO_SIDED|||||||||Mean difference at week 4||||
71915821|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 8||||
71915822|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.09|||||TWO_SIDED|||||||||Mean difference at baseline||||
71915823|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|||||||||Mean difference at week 1||||
71915824|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|||||||||Mean difference at week 2||||
71915825|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 3||||
71915826|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.3|||||TWO_SIDED|||||||||Mean difference at week 4||||
71915827|NCT04507360|143352765|SUPERIORITY||Mean Difference (Final Values)|0.4|||||TWO_SIDED|||||||||Mean difference at week 8||||
71915828|NCT04058990|143352789|NON_INFERIORITY|13.2% non-inferiority margin||||||0.0012|||||||Farrington-Manning|||\[Not Specified\]||||0.0012
71873792|NCT02260882|143266148|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.||||<0.001
71873793|NCT01776424|143266206|SUPERIORITY||Hazard Ratio (HR)|0.76||||4e-05|TWO_SIDED|95.0|0.66|0.86||Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(\~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.86|0.66|0.00004
71873794|NCT01776424|143266206|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1149|TWO_SIDED|95.0|0.79|1.03|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.03|0.79|0.11490
71873795|NCT01776424|143266207|SUPERIORITY||Hazard Ratio (HR)|1.7|||<|1e-05|TWO_SIDED|95.0|1.4|2.05|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||2.05|1.40|<0.00001
71873796|NCT01776424|143266207|SUPERIORITY||Hazard Ratio (HR)|1.51||||3e-05|TWO_SIDED|95.0|1.25|1.84|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.84|1.25|0.00003
71873797|NCT01776424|143266208|SUPERIORITY||Hazard Ratio (HR)|0.72||||1e-05|TWO_SIDED|95.0|0.63|0.83||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.83|0.63|0.00001
71873798|NCT01776424|143266208|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.06437|TWO_SIDED|95.0|0.77|1.01||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.01|0.77|0.06437
71873799|NCT01776424|143266209|SUPERIORITY||Hazard Ratio (HR)|0.74||||1e-05|TWO_SIDED|95.0|0.65|0.85||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.85|0.65|0.00001
71873800|NCT01776424|143266209|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.03995||95.0|0.77|0.99||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.99|0.77|0.03995
71915829|NCT03050307|143352791|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-3.7|||||TWO_SIDED|95.0|-10.966|3.339||||||||3.339|-10.966|
71873801|NCT01776424|143266210|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.01062|TWO_SIDED|95.0|0.71|0.96||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||0.96|0.71|0.01062
71873802|NCT01776424|143266210|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.66418|TWO_SIDED|95.0|0.84|1.12||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model|||1.12|0.84|0.66418
71873803|NCT00186069|143266232|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.2||||0.68|TWO_SIDED|95.0|0.77|1.86|||Fisher Exact|||||1.86|0.77|0.68
71915830|NCT03050307|143352792|NON_INFERIORITY|If the primary outcome measure was met, then the hypothesis for this outcome measure was that if the lower bound of the 95% CI of the difference was ≥-10%, noninferiority for TAK-438 relative to lansoprazole with regard to H pylori eradication was declared.|Exact (Clopper-Pearson)|7.2|||||TWO_SIDED|95.0|-4.469|18.825||||||||18.825|-4.469|
71873804|NCT00186069|143266233|SUPERIORITY_OR_OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71873805|NCT00186069|143266234|SUPERIORITY_OR_OTHER|||||||0.95|||||||Fisher Exact|||||||0.95
71873806|NCT01498289|143266251|SUPERIORITY||Cox Proportional Hazard|0.91||||0.83|TWO_SIDED|95.0|0.41|2.05|||Regression, Cox|||||2.05|0.41|0.83
71873807|NCT01498289|143266252|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.02|TWO_SIDED|95.0|0.5|0.93|||Regression, Cox|||||0.93|0.50|0.02
71873808|NCT01498289|143266253|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2|TWO_SIDED|95.0|0.61|1.11|||Regression, Cox|||||1.11|0.61|0.20
71873809|NCT01498289|143266254|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||0.10
71873810|NCT01498289|143266255|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.41|TWO_SIDED|95.0|0.44|1.4|||Regression, Cox|||Statistical analysis for Q1 ERCC1||1.40|0.44|0.41
71873811|NCT01498289|143266255|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.06|TWO_SIDED|95.0|0.32|1.02|||Regression, Cox|||Statistical analysis for Q2 ERCC1||1.02|0.32|0.06
71873812|NCT01498289|143266255|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.66|TWO_SIDED|95.0|0.49|1.58|||Regression, Cox|||Statistical analysis for Q3 ERCC1||1.58|0.49|0.66
71873813|NCT01498289|143266255|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3|TWO_SIDED|95.0|0.42|1.31|||Regression, Cox|||Statistical analysis for Q4 ERCC1||1.31|0.42|0.30
71873814|NCT01794923|143266273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2|TWO_SIDED||||||ANOVA|||Analysis was performed using an analysis of variance (ANOVA) model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||||0.200
71873815|NCT01794923|143266273|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|7.6||||0.23|TWO_SIDED|95.0|-4.81|19.92|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||19.92|-4.81|0.230
71873816|NCT01794923|143266273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.4||||0.484|TWO_SIDED|95.0|-16.81|7.99|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||7.99|-16.81|0.484
71873817|NCT01794923|143266273|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|12.0||||0.077|TWO_SIDED|95.0|-1.32|25.25|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical pain severity rating (PSR), sex, and baseline muscle soreness with movement (MSM) terms.||25.25|-1.32|0.077
71915831|NCT03050307|143352793|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-6.0|||||TWO_SIDED|95.0|-16.644|4.741||||||||4.741|-16.644|
71915832|NCT03050307|143352794|OTHER|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-1.1|||||TWO_SIDED|95.0|-25.175|23.07||||||Epigastric Pain (Postprandial)||23.070|-25.175|
71915833|NCT03050307|143352794|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|4.5|||||TWO_SIDED|95.0|-11.907|20.931||||||Epigastric Pain (Fasting/Nocturnal)||20.931|-11.907|
71915834|NCT03050307|143352794|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|16.0|||||TWO_SIDED|95.0|-11.255|43.321||||||Abdominal Bloating||43.321|-11.255|
71915835|NCT03050307|143352794|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|10.1|||||TWO_SIDED|95.0|-5.109|25.348||||||Heartburn||25.348|-5.109|
71683871|NCT00553358|142886015|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.788||||0.379|TWO_SIDED|95.0|0.46|1.34||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.34|0.46|0.379
71915836|NCT03050307|143352794|NON_INFERIORITY|If the lower bound of the 95% CI is ≥-8%, noninferiority for TAK-438 relative to lansoprazole with regard to gastric ulcer healing was declared.|Exact (Clopper-Pearson)|-12.2|||||TWO_SIDED|95.0|-45.138|20.694||||||Lack of Appetite||20.694|-45.138|
71915837|NCT05724069|143352804|SUPERIORITY||Median Difference (Net)|-0.239|||=|0.1279|TWO_SIDED|95.0|-0.553|0.074|||paired T-test|||Subjects in this analysis are 15 and not 30 (this happens because arms are not mutually exclusive, as explained in previous sections). Each subject can contribute with 0, 1, 2 pairs. Only data that constitute pairs evaluable for primary endpoint are considered in the analysis; the pairs evaluable for primary endpoint were 23.||0.074|-0.553|=0.1279
71915838|NCT03552289|143352805|SUPERIORITY|||||||0.8283|||||||One-sided Z-test|||||||0.8283
71915839|NCT01536418|143352819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.1|||||TWO_SIDED|95.0|-3.0|19.3||||||||19.3|-3.0|
71873818|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.860
71873819|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|7.0||||0.584|TWO_SIDED|95.0|-18.3|32.38|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||32.38|-18.30|0.584
71873820|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.6||||0.838|TWO_SIDED|95.0|-22.77|28.06|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.06|-22.77|0.838
71873821|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.4||||0.75|TWO_SIDED|95.0|-22.81|31.61|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||31.61|-22.81|0.750
71873822|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.533
71873823|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-13.9||||0.326|TWO_SIDED|95.0|-41.81|13.95|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||13.95|-41.81|0.326
71873824|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.0||||0.945|TWO_SIDED|95.0|-26.98|28.94|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||28.94|-26.98|0.945
71873825|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-14.9||||0.327|TWO_SIDED|95.0|-44.85|15.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||15.03|-44.85|0.327
71873826|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.988|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.988
71873827|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.2||||0.887|TWO_SIDED|95.0|-48.31|41.81|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||41.81|-48.31|0.887
71873828|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.7||||0.907|TWO_SIDED|95.0|-47.88|42.5|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||42.50|-47.88|0.907
71873829|NCT01794923|143266274|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.982|TWO_SIDED|95.0|-48.95|47.83|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||47.83|-48.95|0.982
71873830|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.630
71873831|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.342|TWO_SIDED|95.0|-0.39|0.14|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-0.39|0.342
71873832|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.6|TWO_SIDED|95.0|-0.34|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.34|0.600
71873833|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.691|TWO_SIDED|95.0|-0.34|0.23|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.34|0.691
71873834|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.091
71873835|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.351|TWO_SIDED|95.0|-0.44|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.16|-0.44|0.351
71873836|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.029|TWO_SIDED|95.0|-0.64|-0.04|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||-0.04|-0.64|0.029
71873837|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.238|TWO_SIDED|95.0|-0.13|0.52|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-0.13|0.238
71873838|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.305|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.305
71873839|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.37|TWO_SIDED|95.0|-0.54|0.2|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.20|-0.54|0.370
71873840|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.13|TWO_SIDED|95.0|-0.66|0.09|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.09|-0.66|0.130
71873841|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.561|TWO_SIDED|95.0|-0.28|0.51|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.51|-0.28|0.561
71873842|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.209|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.209
71873843|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.277|TWO_SIDED|95.0|-0.68|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.19|-0.68|0.277
71873844|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.085|TWO_SIDED|95.0|-0.82|0.05|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.05|-0.82|0.085
71915840|NCT01536418|143352820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-5.8|10.8||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 8||10.8|-5.8|
71915841|NCT01536418|143352820|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|5.6|||||TWO_SIDED|95.0|-3.0|14.3||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 12||14.3|-3.0|
71915842|NCT01536418|143352820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.4|||||TWO_SIDED|95.0|-4.6|9.5||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at both Weeks 8 and 12||9.5|-4.6|
71915843|NCT01536418|143352821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-6.0|15.9||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at Week 8||15.9|-6.0|
71915844|NCT01536418|143352821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|||||TWO_SIDED|95.0|-1.0|18.7||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at both Week 8 and Week 12||18.7|-1.0|
71915845|NCT00554853|143352849|SUPERIORITY_OR_OTHER|||||||0.63|||||||ANCOVA|||||||0.63
71915846|NCT01899768|143352902|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.26|||||TWO_SIDED|90.0|1.1|1.44|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.44|1.10|
71915847|NCT01899768|143352903|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.02|||||TWO_SIDED|90.0|0.87|1.19|||||Ratio of adjusted geometric means = GSK2339345/Placebo.|||1.19|0.87|
71915848|NCT01899768|143352926|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.23|||||TWO_SIDED|90.0|0.86|1.75|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.75|0.86|
71915849|NCT01899768|143352926|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|1.36|||||TWO_SIDED|90.0|1.07|1.72|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 4-8 hr.|||1.72|1.07|
71915850|NCT01899768|143352927|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric mean|0.97|||||TWO_SIDED|90.0|0.67|1.4|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.|||1.40|0.67|
71915851|NCT01899768|143352927|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means = GSK2|1.04|||||TWO_SIDED|90.0|0.79|1.36|||Ratio of adjusted geometric mean|||||1.36|0.79|
71915852|NCT00850135|143352986|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED|||||p-Value for the correlation between AUC-110 and birth weight|correlation|||||||0.035
71873845|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.546|TWO_SIDED|95.0|-0.32|0.61|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-0.32|0.546
71915853|NCT02213081|143352988|EQUIVALENCE|Wilcoxon signed rank test was used to determine if the mean difference in pain scores before compared to during ulipristal therapy were equivalent or non-equivalent.|Mean Difference (Net)|3.5|STANDARD_ERROR_OF_MEAN|0.57|<|0.05|TWO_SIDED||||||Wilcoxon signed rank|||||||<0.05
71915854|NCT01487863|143353041|SUPERIORITY|||||||0.2141|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.2141
71915855|NCT00893763|143353070|SUPERIORITY_OR_OTHER|||||||0.1763|TWO_SIDED||||||mixed effects linear model|||We compared groups in a single analytical model using a mixed effects linear model with CPIS as the response variable. For this model, group (CHX, control), day, group by day interaction, APACHE III score and hospital (VCU, USF) were modeled as fixed effects and subject was modeled as a random effect.||||0.1763
71915856|NCT00893763|143353070|SUPERIORITY_OR_OTHER|||||||0.8656|TWO_SIDED||||||Regression, Logistic|||A logistic regression analysis was performed using the binary response variable of colonization or no colonization and dependent variables for group, length of intubation, and group-by-length-of-intubation interaction. The probability of a type 1 error ( a ) was set to 0.05.||||0.8656
71915857|NCT02044367|143353074|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.01|STANDARD_DEVIATION|26.8|||TWO_SIDED|90.0|125.773|149.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.250|125.773|
71873846|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.185
71873847|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.4|TWO_SIDED|95.0|-0.64|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.26|-0.64|0.400
71873848|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.067|TWO_SIDED|95.0|-0.88|0.03|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.03|-0.88|0.067
71873849|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.35|TWO_SIDED|95.0|-0.25|0.71|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.25|0.350
71873850|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.493
71873851|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.922|TWO_SIDED|95.0|-0.53|0.48|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.48|-0.53|0.922
71873852|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.265|TWO_SIDED|95.0|-0.8|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.22|-0.80|0.265
71873853|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.342|TWO_SIDED|95.0|-0.28|0.81|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.81|-0.28|0.342
71873854|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.311|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.311
71873855|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.865|TWO_SIDED|95.0|-0.49|0.58|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.58|-0.49|0.865
71873856|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-0.89|0.18|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.89|0.193
71873857|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.17|TWO_SIDED|95.0|-0.17|0.97|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.97|-0.17|0.170
71873858|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.383|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.383
71873859|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.802|TWO_SIDED|95.0|-0.48|0.62|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.62|-0.48|0.802
71873860|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.87|0.24|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.24|-0.87|0.260
71873861|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|0.98|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.21|0.199
71873862|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.139|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.139
71873863|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.441|TWO_SIDED|95.0|-0.35|0.8|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.80|-0.35|0.441
71683872|NCT00553358|142886015|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.962||||0.88|TWO_SIDED|95.0|0.58|1.6||The two-sided stratified log-rank test was implemented as the score test from the Cox model.|Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate hazard ratios and corresponding confidence intervals for the pairwise comparisons of individual treatment arms with the trastuzumab alone arm.|||1.60|0.58|0.880
71873864|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.183|TWO_SIDED|95.0|-0.96|0.18|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.18|-0.96|0.183
71873865|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.05|TWO_SIDED|95.0|0.0|1.23|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.23|-0.00|0.050
71873866|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.221
71873867|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.526|TWO_SIDED|95.0|-0.4|0.79|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.40|0.526
71873868|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.4||||0.232|TWO_SIDED|95.0|-0.96|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.23|-0.96|0.232
71873869|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.089|TWO_SIDED|95.0|-0.08|1.19|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.19|-0.08|0.089
71873870|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.190
71873871|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.365|TWO_SIDED|95.0|-0.31|0.85|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.85|-0.31|0.365
71873872|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.295|TWO_SIDED|95.0|-0.89|0.27|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.27|-0.89|0.295
71873873|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.069|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.20|-0.05|0.069
71873874|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.197
71873875|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.309|TWO_SIDED|95.0|-0.29|0.92|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.92|-0.29|0.309
71873876|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.359|TWO_SIDED|95.0|-0.89|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.33|-0.89|0.359
71873877|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.072|TWO_SIDED|95.0|-0.05|1.25|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.25|-0.05|0.072
71873878|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.151
71683873|NCT00553358|142886016|SUPERIORITY||Hazard Ratio (HR)|0.481||||0.00079|TWO_SIDED|95.0|0.31|0.73|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the EFS landmark analysis||0.73|0.31|0.00079
71873879|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.6||||0.09|TWO_SIDED|95.0|-0.1|1.32|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.32|-0.10|0.090
71873880|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.889|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.66|-0.76|0.889
71873881|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.7||||0.088|TWO_SIDED|95.0|-0.1|1.42|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.42|-0.10|0.088
71873882|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.673|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.673
71873883|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.393|TWO_SIDED|95.0|-0.41|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.41|0.393
71873884|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.887|TWO_SIDED|95.0|-0.67|0.78|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.78|-0.67|0.887
71873885|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.507|TWO_SIDED|95.0|-0.51|1.04|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.04|-0.51|0.507
71873886|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.873|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.873
71873887|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.605|TWO_SIDED|95.0|-0.58|1.0|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.00|-0.58|0.605
71873888|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.86|TWO_SIDED|95.0|-0.72|0.86|||ANOVA|||26 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.86|-0.72|0.860
71683874|NCT00553358|142886016|SUPERIORITY||Hazard Ratio (HR)|0.35||||0.004|TWO_SIDED|95.0|0.16|0.71|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib + trastuzumab arm||0.71|0.16|0.004
71683875|NCT00553358|142886016|SUPERIORITY||Hazard Ratio (HR)|0.532||||0.134|TWO_SIDED|95.0|0.21|1.16|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the lapatinib arm||1.16|0.21|0.134
71873889|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.751|TWO_SIDED|95.0|-0.71|0.98|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.98|-0.71|0.751
71683876|NCT00553358|142886016|SUPERIORITY||Hazard Ratio (HR)|0.601||||0.163|TWO_SIDED|95.0|0.28|1.2|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the EFS landmark analysis in the trastuzumab arm||1.20|0.28|0.163
71683877|NCT00553358|142886018|SUPERIORITY||Hazard Ratio (HR)|0.366||||0.00041|TWO_SIDED|95.0|0.2|0.63|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Overall - All subjects in the OS landmark analysis||0.63|0.20|0.00041
71683878|NCT00553358|142886018|SUPERIORITY||Hazard Ratio (HR)|0.223||||0.002|TWO_SIDED|95.0|0.07|0.58|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib + trastuzumab arm||0.58|0.07|0.002
71683879|NCT00553358|142886018|SUPERIORITY||Hazard Ratio (HR)|0.433||||0.125|TWO_SIDED|95.0|0.12|1.17|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the lapatinib arm||1.17|0.12|0.125
71873890|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.528|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.528
71873891|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.486|TWO_SIDED|95.0|-1.09|0.52|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.52|-1.09|0.486
71873892|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.61|TWO_SIDED|95.0|-0.6|1.02|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||1.02|-0.60|0.610
71873893|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.261|TWO_SIDED|95.0|-1.36|0.37|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.37|-1.36|0.261
71873894|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.943|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.943
71873895|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.733|TWO_SIDED|95.0|-0.96|0.68|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.68|-0.96|0.733
71873896|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.902|TWO_SIDED|95.0|-0.87|0.77|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.77|-0.87|0.902
71873897|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.84|TWO_SIDED|95.0|-0.97|0.79|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.79|-0.97|0.840
71873898|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.758
71873899|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.493|TWO_SIDED|95.0|-1.12|0.54|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.54|-1.12|0.493
71873900|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.974|TWO_SIDED|95.0|-0.84|0.82|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.82|-0.84|0.974
71873901|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.543|TWO_SIDED|95.0|-1.16|0.61|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.61|-1.16|0.543
71873902|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.238|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||||0.238
71873903|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.106|TWO_SIDED|95.0|-1.46|0.14|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.14|-1.46|0.106
71873904|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.817|TWO_SIDED|95.0|-0.9|0.71|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.71|-0.90|0.817
71873905|NCT01794923|143266275|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.197|TWO_SIDED|95.0|-1.43|0.3|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||0.30|-1.43|0.197
71873906|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.702|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.702
71873907|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.8||||0.664|TWO_SIDED|95.0|-9.91|15.53|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||15.53|-9.91|0.664
71873908|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-3.0||||0.637|TWO_SIDED|95.0|-15.77|9.68|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||9.68|-15.77|0.637
71873909|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|5.9||||0.401|TWO_SIDED|95.0|-7.85|19.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||19.57|-7.85|0.401
71873910|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.926|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.926
71873911|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.743|TWO_SIDED|95.0|-29.51|21.1|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||21.10|-29.51|0.743
71873912|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.8||||0.952|TWO_SIDED|95.0|-24.55|26.08|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.08|-24.55|0.952
71873913|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.0||||0.719|TWO_SIDED|95.0|-32.25|22.3|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||22.30|-32.25|0.719
71873914|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.284|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.284
71873915|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-19.0||||0.171|TWO_SIDED|95.0|-46.21|8.28|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||8.28|-46.21|0.171
71915858|NCT02044367|143353074|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|130.43|STANDARD_DEVIATION|27.1|||TWO_SIDED|90.0|119.628|142.2|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||142.200|119.628|
71915859|NCT02044367|143353075|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|146.16|STANDARD_DEVIATION|31.6|||TWO_SIDED|90.0|132.217|161.576|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||161.576|132.217|
71915860|NCT02044367|143353075|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|141.06|STANDARD_DEVIATION|31.5|||TWO_SIDED|90.0|127.644|155.876|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||155.876|127.644|
71915861|NCT02044367|143353076|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.61|STANDARD_DEVIATION|26.5|||TWO_SIDED|90.0|126.418|149.797|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||149.797|126.418|
71915862|NCT02044367|143353076|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|132.0|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|120.714|144.342|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||144.342|120.714|
71915863|NCT02044367|143353077|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|147.8|STANDARD_DEVIATION|32.4|||TWO_SIDED|90.0|133.384|163.779|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||163.779|133.384|
71915864|NCT02044367|143353077|NON_INFERIORITY_OR_EQUIVALENCE|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|144.8|STANDARD_DEVIATION|32.0|||TWO_SIDED|90.0|130.853|160.242|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for 'sequence', 'period' and 'treatment' as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.||160.242|130.853|
71915865|NCT04157751|143353082|OTHER||Stratified Win Ratio|1.36||||0.0027|TWO_SIDED|95.0|1.09|1.68||p-value for WR\<=1.0 (one-sided), variance calculated using the asymptotic normal U statistics approach.|Asymptotic normal U statistics approach||WR estimate= \[((a)+(c)+(e)+(g)) / ((b)+(d)+(f)+(h))\]|"Stratified win ratio (WR) was used, calculated as total number of wins in the empa group across all strata divided by total number of losses. Weights were applied analogous to a Mantel-Haenszel approach.~1. death in pbo first;~2. death in empa first;~3. HFEs in pbo more frequently;~4. HFEs in empa more frequently;~5. HFEs in pbo first;~6. HFEs in empa first;~7. KCCQ-TSS change lower in pbo;~8. KCCQ-TSS change lower in empa"||1.68|1.09|0.0027
71915866|NCT04157751|143353083|OTHER||Odds Ratio (OR)|1.522|STANDARD_ERROR_OF_MEAN|0.386||0.097|TWO_SIDED|95.0|0.927|2.501||p-value for OR=1.0 (two-sided).|Regression, Logistic|Wald Confidence interval.|Comparison vs. Placebo.|Logistic regression including terms for baseline KCCQ-TSS, treatment and heart failure status||2.501|0.927|0.0970
71915867|NCT04157751|143353084|OTHER||Difference of adjusted mean|4.45|STANDARD_ERROR_OF_MEAN|2.1||0.0347|TWO_SIDED|95.0|0.32|8.59||p-value for difference = 0 (two-sided)|Mixed Models Analysis|||Restricted maximum likelihood estimation based on a mixed-effect model for repeated measures (MMRM) analysis to obtain adjusted means for the treatment effects. This model included discrete fixed effects for treatment group, and heart failure status at each visit and continuous fixed effects for baseline value at each visit. Missing data caused by patient withdrawal or other reasons were handled implicitly by the MMRM approach. Unstructured covariance structure was used.||8.59|0.32|0.0347
71915868|NCT04157751|143353085|OTHER||Adjusted geometric mean ratio|0.9||||0.0176|TWO_SIDED|95.0|0.82|0.98|||ANCOVA|ANCOVA with a discrete fixed effect for heart failure status and a continuous fixed effect for baseline NT-proBNP level.|Comparison vs. Placebo|Area under the curve (AUC) of change from baseline in log-transformed NT-proBNP level over 30 days of treatment was analysed by an analysis of covariance (ANCOVA). NT-proBNP level is regarded as log-normally distributed, therefore values were log-transformed prior to analysis. The linear trapezoidal rule was used to calculate the AUC after the log-transformation had been applied to each value.||0.98|0.82|0.0176
71915869|NCT04157751|143353088|OTHER||Hazard Ratio (HR)|0.71||||0.1241|TWO_SIDED|95.0|0.46|1.1||p-value for HR=1.0 (two sided)|Regression, Cox|Cox proportional hazard model with terms for heart failure status and treatment.|Comparison vs. Placebo.|||1.10|0.46|0.1241
71915870|NCT00423592|143353106|SUPERIORITY_OR_OTHER||Proportion|0.0|STANDARD_DEVIATION|0.0||0.01|TWO_SIDED|95.0|0.0|9.7|||Exact binomial test|A 1-sample test for a binomial proportion was performed.||Sample size: 30 participants; 80% power to rule out 50% recurrence rate of serum ALT/AST abnormalities following ambrisentan treatment (assumes 25% recurrence rate); 99% power to rule out 75% recurrence rate (assumes 37.5% recurrence rate). H\_0 = proportion of subjects experiencing primary endpoint at 12% vs 1-sided alternative of \< 12%. P-value from exact binomial test. Summary statistics included the estimated proportion, 95% confidence interval (CI), and the p-value of the hypothesis test.||9.7|0.0|0.01
71915871|NCT00423592|143353109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.4|STANDARD_DEVIATION|49.6||0.009|TWO_SIDED|95.0|6.3|40.4|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) 6-minute walk distance change from baseline.||40.4|6.3|0.009
71915872|NCT00423592|143353110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|1.51||0.046|TWO_SIDED|95.0|-1.0|0.0|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) Borg dyspnea index change from baseline.||0.0|-1.0|0.046
71915873|NCT00423592|143353112|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6|STANDARD_DEVIATION|6.44||0.001|TWO_SIDED|95.0|2.1|7.1|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.1|2.1|0.001
71915874|NCT00423592|143353113|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|STANDARD_DEVIATION|8.98||0.059|TWO_SIDED|95.0|-0.1|6.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.8|-0.1|0.059
71915875|NCT00423592|143353114|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.4|STANDARD_DEVIATION|6.86||0.002|TWO_SIDED|95.0|1.7|7.0|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.0|1.7|0.002
71915876|NCT00423592|143353115|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.2|STANDARD_DEVIATION|10.56||0.001|TWO_SIDED|95.0|3.1|11.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||11.3|3.1|0.001
71915877|NCT00423592|143353116|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.4||0.017|TWO_SIDED|95.0|0.6|5.6|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.6|0.6|0.017
71915878|NCT00423592|143353117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|7.45||0.046|TWO_SIDED|95.0|0.1|5.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||5.8|0.1|0.046
71915879|NCT00423592|143353118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5|STANDARD_DEVIATION|7.23||0.003|TWO_SIDED|95.0|1.7|7.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.3|1.7|0.003
71915880|NCT00423592|143353119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|9.41||0.059|TWO_SIDED|95.0|-0.1|7.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||7.2|-0.1|0.059
71915881|NCT00423592|143353120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|13.96||0.152|TWO_SIDED|95.0|-1.5|9.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||9.3|-1.5|0.152
71915882|NCT00423592|143353121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_DEVIATION|5.78||0.001|TWO_SIDED|95.0|1.7|6.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.||6.2|1.7|0.001
71915883|NCT03446612|143353122|OTHER||FBF ratio difference|0.6953|STANDARD_DEVIATION|0.12998|||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (7.5 ug/min) is presented.|||||
71915884|NCT03446612|143353122|OTHER||FBF ratio difference|0.1683|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (15 ug/min) is presented.|||||
71915885|NCT03446612|143353122|OTHER||FBF ratio difference|0.3238|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to acetylcholine (30 ug/min) is presented.|||||
71915886|NCT03446612|143353124|OTHER||FBF ratio difference|0.2968|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (3 ug/min) is presented.|||||
71915887|NCT03446612|143353124|OTHER||FBF ratio difference|1.4425|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to sodium nitroprusside (10 ug/min) is presented.|||||
71915888|NCT03446612|143353126|OTHER||FBF ratio difference|-0.1598|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (2 umol/min) is presented.|||||
71915889|NCT03446612|143353126|OTHER||FBF ratio difference|-0.3715|||||||||||||The difference between daprodustat and darbepoetin alfa FBF ratio in response to L-NMMA (8 umol/min) is presented.|||||
71915890|NCT04445051|143353175|SUPERIORITY||Mean Difference (Final Values)|32.9||||0.01|TWO_SIDED|95.0|8.3|57.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||57.5|8.3|0.010
71873916|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.2||||0.875|TWO_SIDED|95.0|-25.08|29.42|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||29.42|-25.08|0.875
71873917|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.1||||0.157|TWO_SIDED|95.0|-50.5|8.23|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline MSM terms.||8.23|-50.50|0.157
71873918|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY|||||||0.699|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||||0.699
71873919|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-17.8||||0.433|TWO_SIDED|95.0|-62.58|26.9|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||26.90|-62.58|0.433
71873920|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.0||||0.966|TWO_SIDED|95.0|-45.73|43.78|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||43.78|-45.73|0.966
71873921|NCT01794923|143266276|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-16.9||||0.491|TWO_SIDED|95.0|-65.08|31.36|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline spontaneous muscle soreness (SMS) terms.||31.36|-65.08|0.491
71873922|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.219|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.219
71873923|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.214|TWO_SIDED|95.0|-0.37|0.08|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.08|-0.37|0.214
71873924|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.555|TWO_SIDED|95.0|-0.16|0.29|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.29|-0.16|0.555
71873925|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.09|TWO_SIDED|95.0|-0.45|0.03|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.03|-0.45|0.090
71873926|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.161|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.161
71873927|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.056|TWO_SIDED|95.0|-0.55|0.01|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.01|-0.55|0.056
71873928|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.395|TWO_SIDED|95.0|-0.4|0.16|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.16|-0.40|0.395
71873929|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.324|TWO_SIDED|95.0|-0.45|0.15|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.15|-0.45|0.324
71873930|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.246|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.246
71873931|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.094|TWO_SIDED|95.0|-0.68|0.05|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.05|-0.68|0.094
71873932|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.491|TWO_SIDED|95.0|-0.5|0.24|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.24|-0.50|0.491
71873933|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.359|TWO_SIDED|95.0|-0.58|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-0.58|0.359
71873934|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.294
71873935|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.136|TWO_SIDED|95.0|-0.74|0.1|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.10|-0.74|0.136
71873936|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.293|TWO_SIDED|95.0|-0.65|0.2|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-0.65|0.293
71873937|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.682|TWO_SIDED|95.0|-0.55|0.36|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.55|0.682
71873938|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.747|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.747
71873939|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.592|TWO_SIDED|95.0|-0.6|0.34|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.60|0.592
71873940|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.473|TWO_SIDED|95.0|-0.64|0.3|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.64|0.473
71873941|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.866|TWO_SIDED|95.0|-0.46|0.55|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.55|-0.46|0.866
71873942|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.776|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.776
71873943|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.59|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.43|-0.59|0.761
71873944|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.477|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.33|-0.69|0.477
71873945|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.705|TWO_SIDED|95.0|-0.44|0.65|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-0.44|0.705
71873946|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.600
71873947|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.931|TWO_SIDED|95.0|-0.52|0.56|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.56|-0.52|0.931
71873948|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.381|TWO_SIDED|95.0|-0.78|0.3|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.30|-0.78|0.381
71873949|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.371|TWO_SIDED|95.0|-0.32|0.85|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.85|-0.32|0.371
71873950|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.67|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.670
71873951|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.941|TWO_SIDED|95.0|-0.54|0.58|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.58|-0.54|0.941
71873952|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.437|TWO_SIDED|95.0|-0.78|0.34|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.34|-0.78|0.437
71873953|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.429|TWO_SIDED|95.0|-0.36|0.84|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.84|-0.36|0.429
71873954|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.484|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.484
71873955|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.504|TWO_SIDED|95.0|-0.38|0.78|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.78|-0.38|0.504
71873956|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.528|TWO_SIDED|95.0|-0.77|0.4|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-0.77|0.528
71873957|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.229|TWO_SIDED|95.0|-0.24|1.01|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.01|-0.24|0.229
71873958|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.536
71873959|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.49|0.7|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.70|-0.49|0.728
71873960|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.414|TWO_SIDED|95.0|-0.84|0.35|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-0.84|0.414
71873961|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.28|TWO_SIDED|95.0|-0.29|0.99|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.29|0.280
71873962|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.402|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.402
71873963|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.513|TWO_SIDED|95.0|-0.41|0.81|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.81|-0.41|0.513
71873964|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.424|TWO_SIDED|95.0|-0.86|0.36|||ANOVA|||11 hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.36|-0.86|0.424
71873965|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.178|TWO_SIDED|95.0|-0.21|1.1|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.10|-0.21|0.178
71873966|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.442|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.442
71915891|NCT04445051|143353175|SUPERIORITY||Mean Difference (Final Values)|34.3||||0.007|TWO_SIDED|95.0|9.8|58.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||58.8|9.8|0.007
71915892|NCT04445051|143353175|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.908|TWO_SIDED|95.0|-23.1|25.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||25.9|-23.1|0.908
71915893|NCT04445051|143353175|SUPERIORITY||Mean Difference (Final Values)|35.3||||0.006|TWO_SIDED|95.0|10.8|59.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||59.8|10.8|0.006
71915894|NCT04445051|143353175|SUPERIORITY||Mean Difference (Final Values)|36.8||||0.005|TWO_SIDED|95.0|11.9|61.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||61.8|11.9|0.005
71915895|NCT04445051|143353175|SUPERIORITY||Mean Difference (Final Values)|1.5||||0.899|TWO_SIDED|95.0|-23.3|26.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||26.5|-23.3|0.899
71915896|NCT04445051|143353176|SUPERIORITY||Mean Difference (Final Values)|8.8||||0.665|TWO_SIDED|95.0|-31.9|49.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.6|-31.9|0.665
71873967|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.357|TWO_SIDED|95.0|-0.33|0.91|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.91|-0.33|0.357
71915897|NCT04445051|143353176|SUPERIORITY||Mean Difference (Final Values)|-18.1||||0.375|TWO_SIDED|95.0|-58.7|22.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||22.4|-58.7|0.375
71915898|NCT04445051|143353176|SUPERIORITY||Mean Difference (Final Values)|-27.0||||0.188|TWO_SIDED|95.0|-67.6|13.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||13.6|-67.6|0.188
71915899|NCT04445051|143353176|SUPERIORITY||Mean Difference (Final Values)|-18.6||||0.361|TWO_SIDED|95.0|-59.3|21.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.9|-59.3|0.361
71873968|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.675|TWO_SIDED|95.0|-0.75|0.49|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.49|-0.75|0.675
71873969|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.25|1.09|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.09|-0.25|0.215
71873970|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.643|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.643
71873971|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.466|TWO_SIDED|95.0|-0.46|0.99|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.99|-0.46|0.466
71873972|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.818|TWO_SIDED|95.0|-0.81|0.64|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.64|-0.81|0.818
71873973|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.373|TWO_SIDED|95.0|-0.43|1.13|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||1.13|-0.43|0.373
71873974|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.984|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.984
71873975|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.874|TWO_SIDED|95.0|-0.79|0.68|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.68|-0.79|0.874
71873976|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.99|TWO_SIDED|95.0|-0.73|0.74|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.74|-0.73|0.990
71873977|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.875|TWO_SIDED|95.0|-0.85|0.73|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.73|-0.85|0.875
71873978|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.841|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.841
71873979|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.58|TWO_SIDED|95.0|-1.01|0.57|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.57|-1.01|0.580
71873980|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.958|TWO_SIDED|95.0|-0.81|0.77|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.77|-0.81|0.958
71873981|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.643|TWO_SIDED|95.0|-1.05|0.65|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.65|-1.05|0.643
71873982|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.299|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.299
71873983|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS mean Difference|-0.5||||0.23|TWO_SIDED|95.0|-1.26|0.31|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.26|0.230
71873984|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.694|TWO_SIDED|95.0|-0.63|0.94|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.94|-0.63|0.694
71873985|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.14|TWO_SIDED|95.0|-1.48|0.21|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.21|-1.48|0.140
71873986|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.503
71873987|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.5||||0.262|TWO_SIDED|95.0|-1.28|0.35|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.35|-1.28|0.262
71915900|NCT04445051|143353176|SUPERIORITY||Mean Difference (Final Values)|-10.9||||0.6|TWO_SIDED|95.0|-52.3|30.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||30.5|-52.3|0.600
71915901|NCT04445051|143353176|SUPERIORITY||Mean Difference (Final Values)|7.78||||0.707|TWO_SIDED|95.0|-33.5|49.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||49.0|-33.5|0.707
71915902|NCT04445051|143353177|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.615|TWO_SIDED|95.0|-1.08|0.65||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.65|-1.08|0.615
71873988|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.871|TWO_SIDED|95.0|-0.88|0.75|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.75|-0.88|0.871
71873989|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.373|TWO_SIDED|95.0|-1.27|0.48|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.48|-1.27|0.373
71873990|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.413|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.413
71873991|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.317|TWO_SIDED|95.0|-1.22|0.4|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.40|-1.22|0.317
71873992|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.708|TWO_SIDED|95.0|-0.66|0.97|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.97|-0.66|0.708
71683880|NCT00553358|142886018|SUPERIORITY||Hazard Ratio (HR)|0.414||||0.058|TWO_SIDED|95.0|0.15|1.0|||Regression, Cox||Cox models (Cox, 1972), with the stratification factors entered as strata variables, were used to calculate a hazard ratio and corresponding confidence interval comparing pCR and no pCR.|Subjects in the OS landmark analysis in the trastuzumab arm||1.00|0.15|0.058
71873993|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.202|TWO_SIDED|95.0|-1.44|0.31|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.31|-1.44|0.202
71873994|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||||0.190
71873995|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7||||0.094|TWO_SIDED|95.0|-1.44|0.11|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.11|-1.44|0.094
71873996|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.96|TWO_SIDED|95.0|-0.8|0.76|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.76|-0.80|0.960
71873997|NCT01794923|143266277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.6||||0.132|TWO_SIDED|95.0|-1.48|0.2|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMS terms.||0.20|-1.48|0.132
71873998|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|TWO_SIDED||||||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.163
71873999|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|4.6||||0.162|TWO_SIDED|95.0|-1.86|11.02|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.02|-1.86|0.162
71915903|NCT04445051|143353177|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.48|TWO_SIDED|95.0|-1.17|0.56||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.56|-1.17|0.480
71915904|NCT04445051|143353177|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.839|TWO_SIDED|95.0|-0.95|0.77||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.77|-0.95|0.839
71915905|NCT04445051|143353177|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.894|TWO_SIDED|95.0|-0.92|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.92|0.894
71915906|NCT04445051|143353177|SUPERIORITY||Mean Difference (Final Values)|-0.58||||0.195|TWO_SIDED|95.0|-1.46|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-1.46|0.195
71683881|NCT03887429|142886056|SUPERIORITY||||||=|0.009|||||||t-test, 1 sided|||It was hypothesized that treatment with SXC-2023 would reduce impulsivity as measured by SSRT in chronic cigarette smokers abstaining from nicotine for 5 days.||||=.009
71915907|NCT04445051|143353177|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.242|TWO_SIDED|95.0|-1.4|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.40|0.242
71874000|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.9||||0.559|TWO_SIDED|95.0|-8.42|4.57|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||4.57|-8.42|0.559
71874001|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|6.5||||0.066|TWO_SIDED|95.0|-0.44|13.45|||ANOVA|||0-24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.45|-0.44|0.066
71874002|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|TWO_SIDED||||||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.957
71874003|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.1||||0.864|TWO_SIDED|95.0|-11.2|13.33|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||13.33|-11.20|0.864
71874004|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.9||||0.883|TWO_SIDED|95.0|-13.3|11.45|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||11.45|-13.30|0.883
71874005|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.767|TWO_SIDED|95.0|-11.24|15.22|||ANOVA|||24-48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||15.22|-11.24|0.767
71683882|NCT03887429|142886057|SUPERIORITY||||||=|0.015|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would result in increased risk taking behavior as measured using DAVT in subjects receiving placebo as treatment.||||=.015
71683883|NCT03887429|142886057|SUPERIORITY||||||>|0.1|||||||t-test, 1 sided|||It was hypothesized that 5 days of nicotine abstinence in chronic cigarette smokers would not result in increased risk taking behavior as measured using DAVT in subjects treated with SXC-2023.||||>.1
71874006|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243|TWO_SIDED||||||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.243
71874007|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-8.2||||0.176|TWO_SIDED|95.0|-20.12|3.7|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||3.70|-20.12|0.176
71874008|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.0||||0.741|TWO_SIDED|95.0|-10.0|14.03|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||14.03|-10.00|0.741
71874009|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-10.2||||0.118|TWO_SIDED|95.0|-23.07|2.62|||ANOVA|||48-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||2.62|-23.07|0.118
71874010|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|TWO_SIDED||||||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.920
71874011|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.2||||0.685|TWO_SIDED|95.0|-24.64|16.23|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||16.23|-24.64|0.685
71874012|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-1.4||||0.892|TWO_SIDED|95.0|-22.04|19.19|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.19|-22.04|0.892
71874013|NCT01794923|143266278|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-2.8||||0.804|TWO_SIDED|95.0|-24.82|19.25|||ANOVA|||0-72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||19.25|-24.82|0.804
71874014|NCT01794923|143266279|SUPERIORITY_OR_OTHER_LEGACY|||||||0.533|TWO_SIDED||||||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||||0.533
71874015|NCT01794923|143266279|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.5||||0.266|TWO_SIDED|95.0|-0.38|1.38|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.38|-0.38|0.266
71874016|NCT01794923|143266279|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.73|TWO_SIDED|95.0|-0.74|1.05|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.05|-0.74|0.730
71874017|NCT01794923|143266279|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.479|TWO_SIDED|95.0|-0.61|1.3|||ANOVA|||Analysis was performed using an ANOVA model with treatment, baseline categorical PSR, sex, and baseline SMSM terms.||1.30|-0.61|0.479
71874018|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.189|TWO_SIDED||||||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.189
71874019|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.389|TWO_SIDED|95.0|-0.17|0.07|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.17|0.389
71874020|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.273|TWO_SIDED|95.0|-0.05|0.19|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.05|0.273
71874021|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.069|TWO_SIDED|95.0|-0.25|0.01|||ANOVA|||1 Hour: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.01|-0.25|0.069
71874022|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.716|TWO_SIDED||||||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.716
71874023|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.735|TWO_SIDED|95.0|-0.15|0.11|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.15|0.735
71683884|NCT02943785|142886065|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.05||||0.0141|TWO_SIDED|95.0|0.85|1.31|||Regression, Cox|||||1.31|0.85|0.0141
71683885|NCT02943785|142886066|NON_INFERIORITY|The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.|Cox Proportional Hazard|1.4||||0.9267|TWO_SIDED|95.0|1.03|1.91|||Regression, Cox|||||1.91|1.03|0.9267
71874024|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.414|TWO_SIDED|95.0|-0.19|0.08|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.08|-0.19|0.414
71874025|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.652|TWO_SIDED|95.0|-0.11|0.17|||ANOVA|||2 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.17|-0.11|0.652
71874026|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.622|TWO_SIDED||||||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.622
71874027|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.83|TWO_SIDED|95.0|-0.17|0.21|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.17|0.830
71874028|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.442|TWO_SIDED|95.0|-0.26|0.11|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.26|0.442
71915908|NCT04445051|143353178|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.639|TWO_SIDED|95.0|-1.2|0.74||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.74|-1.20|0.639
71915909|NCT04445051|143353178|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.492|TWO_SIDED|95.0|-1.3|0.63||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.63|-1.30|0.492
71874029|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.358|TWO_SIDED|95.0|-0.11|0.29|||ANOVA|||3 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.11|0.358
71874030|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.714|TWO_SIDED||||||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.714
71874031|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.683|TWO_SIDED|95.0|-0.29|0.19|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.29|0.683
71874032|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.413|TWO_SIDED|95.0|-0.34|0.14|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.14|-0.34|0.413
71874033|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.699|TWO_SIDED|95.0|-0.21|0.31|||ANOVA|||4 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.21|0.699
71915910|NCT04445051|143353178|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.828|TWO_SIDED|95.0|-1.07|0.86||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.86|-1.07|0.828
71915911|NCT04445051|143353178|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.744|TWO_SIDED|95.0|-0.81|1.13||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.13|-0.81|0.744
71915912|NCT04445051|143353178|SUPERIORITY||Mean Difference (Final Values)|-0.63||||0.208|TWO_SIDED|95.0|-1.62|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-1.62|0.208
71915913|NCT04445051|143353178|SUPERIORITY||Mean Difference (Final Values)|-0.79||||0.116|TWO_SIDED|95.0|-1.77|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.77|0.116
71915914|NCT04445051|143353179|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.798|TWO_SIDED|95.0|-0.75|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.75|0.798
71915915|NCT04445051|143353179|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.556|TWO_SIDED|95.0|-1.1|0.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.60|-1.10|0.556
71915916|NCT04445051|143353179|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.399|TWO_SIDED|95.0|-1.21|0.49||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.49|-1.21|0.399
71915917|NCT04445051|143353179|SUPERIORITY||Mean Difference (Final Values)|0.55||||0.198|TWO_SIDED|95.0|-0.3|1.41||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.41|-0.30|0.198
71915918|NCT04445051|143353179|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.365|TWO_SIDED|95.0|-1.27|0.48||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.48|-1.27|0.365
71915919|NCT04445051|143353179|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.033|TWO_SIDED|95.0|-1.82|-0.08||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.08|-1.82|0.033
71915920|NCT04445051|143353180|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.882|TWO_SIDED|95.0|-0.83|0.96||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.96|-0.83|0.882
71915921|NCT04445051|143353180|SUPERIORITY||Mean Difference (Final Values)|-0.32||||0.478|TWO_SIDED|95.0|-1.21|0.57||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.57|-1.21|0.478
71915922|NCT04445051|143353180|SUPERIORITY||Mean Difference (Final Values)|-0.38||||0.391|TWO_SIDED|95.0|-1.27|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-1.27|0.391
71915923|NCT04445051|143353180|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.657|TWO_SIDED|95.0|-0.69|1.09||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.09|-0.69|0.657
71915924|NCT04445051|143353180|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.125|TWO_SIDED|95.0|-1.62|0.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.20|-1.62|0.125
71915925|NCT04445051|143353180|SUPERIORITY||Mean Difference (Final Values)|-0.91||||0.051|TWO_SIDED|95.0|-1.81|0.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.00|-1.81|0.051
71915926|NCT04445051|143353181|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.877|TWO_SIDED|95.0|-0.83|0.97||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.97|-0.83|0.877
71915927|NCT04445051|143353181|SUPERIORITY||Mean Difference (Final Values)|-0.42||||0.351|TWO_SIDED|95.0|-1.31|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-1.31|0.351
71874034|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.244|TWO_SIDED||||||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.244
71874035|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.21|0.26|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.21|0.833
71874036|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.156|TWO_SIDED|95.0|-0.41|0.07|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.07|-0.41|0.156
71874037|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.128|TWO_SIDED|95.0|-0.06|0.46|||ANOVA|||5 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.06|0.128
71874038|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.359|TWO_SIDED||||||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.359
71874039|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.278|TWO_SIDED|95.0|-0.12|0.43|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.43|-0.12|0.278
71874040|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.699|TWO_SIDED|95.0|-0.33|0.22|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.22|-0.33|0.699
71874041|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.172|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||6 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.172
71874042|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.515|TWO_SIDED||||||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.515
71874043|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.527|TWO_SIDED|95.0|-0.19|0.37|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.37|-0.19|0.527
71874044|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.545|TWO_SIDED|95.0|-0.37|0.19|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.19|-0.37|0.545
71874045|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.25|TWO_SIDED|95.0|-0.12|0.47|||ANOVA|||7 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.47|-0.12|0.250
71874046|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.568|TWO_SIDED||||||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.568
71874047|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.381|TWO_SIDED|95.0|-0.16|0.41|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.41|-0.16|0.381
71874048|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.863|TWO_SIDED|95.0|-0.31|0.26|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.31|0.863
71874049|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.33|TWO_SIDED|95.0|-0.16|0.46|||ANOVA|||8 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.46|-0.16|0.330
71874050|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.167|TWO_SIDED||||||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.167
71874051|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.165|TWO_SIDED|95.0|-0.09|0.5|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.50|-0.09|0.165
71874052|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.39|0.21|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.21|-0.39|0.564
71874053|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.068|TWO_SIDED|95.0|-0.02|0.62|||ANOVA|||9 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.62|-0.02|0.068
71874054|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131|TWO_SIDED||||||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.131
71874055|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.119|TWO_SIDED|95.0|-0.06|0.56|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.56|-0.06|0.119
71874056|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.616|TWO_SIDED|95.0|-0.39|0.23|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.39|0.616
71874057|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.056|TWO_SIDED|95.0|-0.01|0.66|||ANOVA|||10 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.01|0.056
71915928|NCT04445051|143353181|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.278|TWO_SIDED|95.0|-1.38|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-1.38|0.278
71915929|NCT04445051|143353181|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.711|TWO_SIDED|95.0|-0.73|1.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.06|-0.73|0.711
71915930|NCT04445051|143353181|SUPERIORITY||Mean Difference (Final Values)|-1.06||||0.024|TWO_SIDED|95.0|-1.97|-0.15||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.15|-1.97|0.024
71915931|NCT04445051|143353181|SUPERIORITY||Mean Difference (Final Values)|-1.23||||0.009|TWO_SIDED|95.0|-2.14|-0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)\*Gender (male and females)||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.31|-2.14|0.009
71915932|NCT00997555|143353193|SUPERIORITY_OR_OTHER|||||||0.6||95.0|||||Chi-squared|||||||0.6
71915933|NCT00997555|143353194|SUPERIORITY_OR_OTHER|||||||0.7||95.0||||(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|t-test, 2 sided|||||||0.7
71915934|NCT00997555|143353195|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 2 sided|(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).||||||0.4
71915935|NCT00997555|143353196|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||t-test, 2 sided|(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).||||||0.5
71915936|NCT00901394|143353197|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||For baseline comparisons among the three groups, one-way ANOVA was used for normally distributed variables and χ2 goodness-of-fit for categorical variables. To model the effects of B-vitamin treatment on nitrous-oxide-induced total homocysteine increase at the three different timepoints within individual patients and between the three groups, a linear mixed model with was used and we included a group × time interaction in the model.||||<0.05
71915937|NCT00864123|143353198|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_DEVIATION|6.3|<|0.05||95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
71915938|NCT00864123|143353199|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|1.1|<|0.05|TWO_SIDED|95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen's d was used to examine the magnitude of treatment effects.||||<0.05
71915939|NCT00796224|143353201|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|157.98||||||90.0|98.87|252.44|||ANOVA|||Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR)||252.44|98.87|
71915940|NCT00796224|143353203|SUPERIORITY_OR_OTHER||Ratio of Geometric Means|91.63||||||90.0|56.21|149.38|||ANOVA|||||149.38|56.21|
71915941|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|65.44||||||90.0|23.56|181.77|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 1 hour postdose||181.77|23.56|
71874058|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.255|TWO_SIDED||||||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.255
71874059|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.144|TWO_SIDED|95.0|-0.08|0.57|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.57|-0.08|0.144
71683886|NCT01490697|142886137|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-18.0|16.0|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||16|-18|
71874060|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.935|TWO_SIDED|95.0|-0.34|0.31|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.31|-0.34|0.935
71874061|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.153|TWO_SIDED|95.0|-0.1|0.61|||ANOVA|||11 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.61|-0.10|0.153
71874062|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.128|TWO_SIDED||||||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.128
71874063|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.067|TWO_SIDED|95.0|-0.02|0.63|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.63|-0.02|0.067
71874064|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.999|TWO_SIDED|95.0|-0.33|0.33|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.33|-0.33|0.999
71874065|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.088|TWO_SIDED|95.0|-0.05|0.66|||ANOVA|||12 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.66|-0.05|0.088
71874066|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.195|TWO_SIDED||||||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.195
71874067|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.3||||0.175|TWO_SIDED|95.0|-0.12|0.67|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.67|-0.12|0.175
71874068|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.61|TWO_SIDED|95.0|-0.5|0.3|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.30|-0.50|0.610
71874069|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.4||||0.083|TWO_SIDED|95.0|-0.05|0.81|||ANOVA|||24 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.81|-0.05|0.083
71874070|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.884|TWO_SIDED||||||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.884
71874071|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.43|0.35|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.35|-0.43|0.833
71874072|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.62|TWO_SIDED|95.0|-0.49|0.29|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.29|-0.49|0.620
71683887|NCT01490697|142886138|SUPERIORITY||Mean Difference (Net)|3.9|||||TWO_SIDED|95.0|-6.9|14.7|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)|||14.7|-6.9|
71683888|NCT00090584|142886139|SUPERIORITY_OR_OTHER||Difference in cumulative success rates|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.74|TWO_SIDED|95.0|-0.12|0.12|||Log Rank|||Kaplan Meier Lifetable analysis was used to compute the 8 month cumulative success rates.||0.12|-0.12|0.74
71874073|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.788|TWO_SIDED|95.0|-0.36|0.48|||ANOVA|||30 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.48|-0.36|0.788
71874074|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.755|TWO_SIDED||||||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.755
71874075|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.787|TWO_SIDED|95.0|-0.45|0.34|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.34|-0.45|0.787
71874076|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.455|TWO_SIDED|95.0|-0.56|0.25|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.25|-0.56|0.455
71874077|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.654|TWO_SIDED|95.0|-0.33|0.53|||ANOVA|||36 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.33|0.654
71874078|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED||||||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.370
71874079|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.472|TWO_SIDED|95.0|-0.51|0.24|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.51|0.472
71874080|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.2||||0.427|TWO_SIDED|95.0|-0.23|0.53|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.53|-0.23|0.427
71874081|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.159|TWO_SIDED|95.0|-0.69|0.11|||ANOVA|||48 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.69|0.159
71874082|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48|TWO_SIDED||||||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.480
71874083|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.238|TWO_SIDED|95.0|-0.59|0.15|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.15|-0.59|0.238
71874084|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.0||||0.794|TWO_SIDED|95.0|-0.42|0.32|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.32|-0.42|0.794
71874085|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.395|TWO_SIDED|95.0|-0.57|0.23|||ANOVA|||54 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.23|-0.57|0.395
71874086|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|TWO_SIDED||||||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.400
71874087|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.2||||0.176|TWO_SIDED|95.0|-0.61|0.11|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.11|-0.61|0.176
71874088|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.573|TWO_SIDED|95.0|-0.47|0.26|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.26|-0.47|0.573
71874089|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.1||||0.466|TWO_SIDED|95.0|-0.53|0.24|||ANOVA|||60 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.24|-0.53|0.466
71874090|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092|TWO_SIDED||||||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||||0.092
71874091|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.3||||0.086|TWO_SIDED|95.0|-0.67|0.04|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.04|-0.67|0.086
71874092|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.1||||0.616|TWO_SIDED|95.0|-0.27|0.45|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||0.45|-0.27|0.616
71874093|NCT01794923|143266280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.4||||0.04|TWO_SIDED|95.0|-0.79|-0.02|||ANOVA|||72 Hours: Analysis was performed using an ANOVA model with treatment, baseline categorical PSR and sex terms.||-0.02|-0.79|0.040
71874094|NCT01794923|143266281|SUPERIORITY_OR_OTHER_LEGACY|||||||0.751|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||||0.751
71874095|NCT01794923|143266281|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.696|TWO_SIDED|95.0|-0.28|0.2|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.20|-0.28|0.696
71874096|NCT01794923|143266281|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|0.0||||0.76|TWO_SIDED|95.0|-0.21|0.29|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.29|-0.21|0.760
71874097|NCT01794923|143266281|SUPERIORITY_OR_OTHER_LEGACY||Weighted Gamma Statistic|-0.1||||0.463|TWO_SIDED|95.0|-0.36|0.16|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for baseline categorical PSR (BLPSR) and sex.||0.16|-0.36|0.463
71874098|NCT03318809|143266285|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and confidence interval (CI) are based on natural log scale data converted back to the original scale.|||2.10|0.73|
71874099|NCT03318809|143266286|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.41|||||TWO_SIDED|90.0|0.88|2.27|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.27|0.88|
71874100|NCT03318809|143266289|OTHER|Analysis of Variance|Ratio (Group 1/Group 2)|1.24|||||TWO_SIDED|90.0|0.73|2.1|||||The ratio and CI are based on natural log scale data converted back to the original scale.|||2.10|0.73|
71874101|NCT00803270|143266316|SUPERIORITY_OR_OTHER||Difference of proportions|0.08|STANDARD_ERROR_OF_MEAN|0.19||0.99|TWO_SIDED|95.0|-0.28|0.44|||Fisher Exact|||||0.44|-0.28|0.99
71874102|NCT00803270|143266317|SUPERIORITY_OR_OTHER||difference of proportions|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.08|TWO_SIDED|95.0|0.03|0.87||Fisher's Exact Test of equality of percent meeting optimal outcome.|Fisher Exact|||||0.87|0.03|0.08
71874103|NCT02340091|143266340|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9194|||||TWO_SIDED|95.0|0.8|0.97||||||||0.97|0.80|
71874104|NCT01786239|143266378|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Mixed Models Analysis|||||||0.0493
71874105|NCT00292461|143266379|SUPERIORITY_OR_OTHER|||||||0.24|||||||ANOVA|||||||0.240
71874106|NCT00292461|143266380|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Cochran-Mantel-Haenszel|||||||0.460
71874107|NCT00292461|143266381|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Cochran-Mantel-Haenszel|||||||0.079
71874108|NCT00292461|143266382|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||Cochran-Mantel-Haenszel|||||||0.860
71874109|NCT05629962|143266392|SUPERIORITY|||||||0.954|||||||Cochran-Mantel-Haenszel|||||||0.954
71874110|NCT05640648|143266399|OTHER||Incidence rate ratio|1.84|||<|0.001|TWO_SIDED|95.0|1.62|2.09|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||2.09|1.62|<0.001
71683889|NCT00090584|142886140|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9|STANDARD_ERROR_OF_MEAN|2.0||0.34|TWO_SIDED|95.0|-2.0|5.9||Mixed effect repeated measures analysis of variance controlling for study site.|ANOVA|||Test of hypothesis of no difference in change in episodes between the two groups.||5.9|-2.0|0.34
71683890|NCT00090584|142886141|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.08|TWO_SIDED|95.0|-1.7|0.1||Repeated measures ANOVA controlling for clinical site.|ANOVA||Difference (group 1 - group 2) in change from baseline to follow-up in voids per day.|Null hypothesis of no difference between arms in change in number of voids per day from baseline to 10 weeks.||0.1|-1.7|0.08
71915942|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|50.57||||||90.0|25.24|101.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 2 hours postdose||101.30|25.24|
71915943|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|100.07||||||90.0|57.91|172.92|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 3 hours postdose||172.92|57.91|
71915944|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|164.93||||||90.0|103.78|262.12|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 4 hours postdose||262.12|103.78|
71915945|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|174.41||||||90.0|110.07|276.36|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 8 hours postdose||276.36|110.07|
71915946|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|173.01||||||90.0|111.45|268.55|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 24 hours postdose||268.55|111.45|
71915947|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|189.35||||||90.0|129.76|276.3|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 48 hours postdose||276.30|129.76|
71915948|NCT00796224|143353205|SUPERIORITY_OR_OTHER||Ratio of Geometric means (percent)|183.14||||||90.0|124.61|269.14|||ANOVA||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 72 hours postdose||269.14|124.61|
71915949|NCT03227224|143353220|SUPERIORITY||Difference of Least Square Means|0.9||||0.724|TWO_SIDED|90.0|-3.12|4.82|||Mixed model for repeated measures (MMRM)|||||4.82|-3.12|0.724
71915950|NCT03227224|143353220|SUPERIORITY||Difference of Least Square Means|-3.1||||0.083|TWO_SIDED|90.0|-6.13|-0.16|||MMRM|||||-0.16|-6.13|0.083
71915951|NCT03227224|143353220|SUPERIORITY||Difference of Least Square Means|-1.5||||0.424|TWO_SIDED|90.0|-4.7|1.63|||MMRM|||||1.63|-4.70|0.424
71915952|NCT04195750|143353262|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00031|TWO_SIDED|95.0|0.63|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.88|0.63|0.00031
71915953|NCT04195750|143353263|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.17644|TWO_SIDED|95.0|0.77|1.1|||Log Rank|One-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.10|0.77|0.17644
71915954|NCT04195750|143353264|SUPERIORITY|P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Difference in Percentage|18.4|||<|1e-05|TWO_SIDED|95.0|14.0|23.2||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|Miettinen & Nurminen||Belzutifan minus Everolimus|||23.2|14.0|<0.00001
71915955|NCT04195750|143353268|OTHER||Hazard Ratio (HR)|0.75||||0.0185|TWO_SIDED|95.0|0.58|0.96|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.96|0.58|0.0185
71915956|NCT04195750|143353269|OTHER||Hazard Ratio (HR)|0.93||||0.5533|TWO_SIDED|95.0|0.72|1.2|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||1.20|0.72|0.5533
71915957|NCT04195750|143353270|OTHER||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.69|||Log Rank|Two-sided p-value based on log-rank test stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.|||0.69|0.41|<0.0001
71915958|NCT04195750|143353271|OTHER||Difference in Least Squares (LS) Means|6.38|||<|0.0001|TWO_SIDED|95.0|3.21|9.55|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||9.55|3.21|<0.0001
71915959|NCT04195750|143353272|OTHER||Difference in LS Means|2.47||||0.1134|TWO_SIDED|95.0|-0.59|5.54|||t-test, 2 sided||Based on a cLDA model with scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||5.54|-0.59|0.1134
71915960|NCT04195750|143353273|OTHER||Difference in LS Means|1.45||||0.0002|TWO_SIDED|95.0|0.7|2.19|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||2.19|0.70|0.0002
71915961|NCT04195750|143353274|OTHER||Difference in LS Means|3.72||||0.0051|TWO_SIDED|95.0|1.12|6.31|||t-test, 2 sided||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (IMDC Risk Category, and Number of Prior VEGF/VEGF-Receptor Targeted Therapies for RCC) as covariates.|||6.31|1.12|0.0051
71683891|NCT00090584|142886142|SUPERIORITY_OR_OTHER||Other|0.0||||0.0006||95.0||||Repeated measures ANOVA|Mixed Models Analysis|Main hypothesis tested by F-test for treatment by time interaction (2 and 509 degrees of freedom). No parameters estimated.||Null hypothesis is that there is no difference between treatment groups in improvement in UDI over time||||0.0006
71683892|NCT00090584|142886143|SUPERIORITY_OR_OTHER||Other|0.0||||0.0005||95.0||||P-value for test of time by treatment group interaction.|Mixed Models Analysis|Adjusted for study site||Repeated measures analysis of difference in symptom bother over time by treatment group.||||0.0005
71683893|NCT00090584|142886144|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.79||||0.02|TWO_SIDED|95.0|1.09|2.92|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in Combination therapy arm to Drug only arm.|Null hypothesis: no difference in satisfaction at 10 weeks||2.92|1.09|0.02
71683894|NCT00090584|142886145|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.02|TWO_SIDED|95.0|1.11|3.7|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in combination therapy group compared to drug only group.|Null hypothesis: No difference in satisfaction at 8 months post intervention||3.70|1.11|0.02
71683895|NCT00090584|142886146|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55||||0.008|TWO_SIDED|95.0|1.27|5.13||P-value from logistic regression analysis|Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement between women in combination therapy group compared to those in drug only group||5.13|1.27|0.008
71683896|NCT00090584|142886147|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.17|||<|0.0001|TWO_SIDED|95.0|1.83|5.52|||Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement at 8 months between women in combination therapy group compared to those in drug only group.||5.52|1.83|<0.0001
71874111|NCT05640648|143266400|OTHER||Incidence Rate Ratio|7.46||||0.002|TWO_SIDED|95.0|2.06|26.95|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||26.95|2.06|0.002
71874112|NCT05640648|143266401|OTHER||Incidence Rate Ratio|1.25||||0.5|TWO_SIDED|95.0|0.65|2.42|||Mixed Models Analysis|Mixed effects poisson model adjusting for time and group (paired healthcentres, based on randomization)||||2.42|0.65|0.50
71874113|NCT05640648|143266404|OTHER||Incidence Rate Ratio|4.75|||<|0.001|TWO_SIDED|95.0|2.07|10.91|||Mixed Models Analysis|Mixed-effects Poisson model adjusting for time and group level (paired health centres, based on randomization) cluster||||10.91|2.07|<0.001
71874114|NCT04908189|143266406|SUPERIORITY||Adjusted Mean Difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.3031|-0.6455|<0.0001
71874115|NCT04908189|143266407|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||-0.0438|-0.1814|0.0013
71874116|NCT04908189|143266409|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||3.105|0.980|0.0002
71874117|NCT04908189|143266412|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|||2.0|-0.4|0.2017
71874118|NCT04908189|143266416|SUPERIORITY||Adjusted mean difference|0.0643|STANDARD_ERROR_OF_MEAN|0.02831||0.0231|TWO_SIDED|95.0|0.0088|0.1198|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1198|0.0088|0.0231
71874119|NCT04908189|143266416|SUPERIORITY||Adjusted mean difference|0.0085|STANDARD_ERROR_OF_MEAN|0.03126||0.7865|TWO_SIDED|95.0|-0.0528|0.0697|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0697|-0.0528|0.7865
71874120|NCT04908189|143266416|SUPERIORITY||Adjusted mean difference|-0.0515|STANDARD_ERROR_OF_MEAN|0.03386||0.128|TWO_SIDED|95.0|-0.1179|0.0148|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||0.0148|-0.1179|0.1280
71874121|NCT04908189|143266416|SUPERIORITY||Adjusted mean differnce|-0.0541|STANDARD_ERROR_OF_MEAN|0.0346||0.118|TWO_SIDED|95.0|-0.1219|0.0137|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.0137|-0.1219|0.1180
71915962|NCT03559192|143353314|SUPERIORITY||Least Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|1.25|=|0.0443|ONE_SIDED|80.0||-1.09|||Mixed Models Analysis|||||-1.09||= 0.0443
71915963|NCT03559192|143353315|SUPERIORITY||Least Squares Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.05||0.0017|ONE_SIDED|80.0||-2.21|||Mixed Models Analysis|||||-2.21||0.0017
71915964|NCT03559192|143353317|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.87|=|0.4188|ONE_SIDED|80.0||0.41|||Mixed Models Analysis|||||0.41||= 0.4188
71915965|NCT03559192|143353318|SUPERIORITY||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.73||0.2503|ONE_SIDED|80.0||0.1|||Mixed Models Analysis|||||0.10||0.2503
71874122|NCT04908189|143266416|SUPERIORITY||Adjusted mean difference|-0.1126|STANDARD_ERROR_OF_MEAN|0.03511||0.0013|TWO_SIDED|95.0|-0.1814|-0.0438|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.0438|-0.1814|0.0013
71874123|NCT04908189|143266421|SUPERIORITY||Adjusted mean difference|0.692|STANDARD_ERROR_OF_MEAN|0.4384||0.1147|TWO_SIDED|95.0|-0.168|1.551|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||1.551|-0.168|0.1147
71915966|NCT03517722|143353333|SUPERIORITY||Odds Ratio (OR)|0.6||||0.042|TWO_SIDED|95.0|0.4|1.0|||Regression, Logistic|||||1.0|0.4|0.042
71915967|NCT02422186|143353340|SUPERIORITY||Difference of Least Square (LS) Means|-3.6|||=|0.059|TWO_SIDED|95.0|-7.2|0.07|||Mixed Model for Repeated Measures|||||0.07|-7.20|=0.059
71915968|NCT02422186|143353341|OTHER||Least Square (LS) Mean Difference|-3.6|||=|0.052|TWO_SIDED|95.0|-7.16|-0.03|||ANCOVA|||||-0.03|-7.16|=0.052
71915969|NCT05849441|143353350|SUPERIORITY|||||||0.04||||||This is for the subscale: Support-Seeking.|Regression, Linear|||||||0.04
71915970|NCT05849441|143353350|SUPERIORITY|||||||0.02||||||This is for subscale: Problem Solving|Regression, Linear|||||||0.02
71915971|NCT05849441|143353350|SUPERIORITY|||||||0.55||||||This is for subscale: Distancing|Regression, Linear|||||||0.55
71915972|NCT05849441|143353350|SUPERIORITY|||||||0.79||||||This is for subscale: Internalizing|Regression, Linear|||||||0.79
71915973|NCT05849441|143353350|SUPERIORITY|||||||0.93||||||This is for subscale: Externalizing|Regression, Linear|||||||0.93
71874124|NCT04908189|143266421|SUPERIORITY||Adjusted mean difference|1.999|STANDARD_ERROR_OF_MEAN|0.5147||0.0001|TWO_SIDED|95.0|0.991|3.008|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||3.008|0.991|0.0001
71874125|NCT04908189|143266421|SUPERIORITY||Adjusted mean difference|2.042|STANDARD_ERROR_OF_MEAN|0.5421||0.0002|TWO_SIDED|95.0|0.98|3.105|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||3.105|0.980|0.0002
71874126|NCT04908189|143266425|SUPERIORITY||Adjusted mean difference|-0.284|STANDARD_ERROR_OF_MEAN|0.567||0.6159|TWO_SIDED|95.0|-1.396|0.827|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.827|-1.396|0.6159
71915974|NCT05849441|143353350|SUPERIORITY|||||||0.09||||||This is for subscale: Mindfulness|Regression, Linear|||||||0.09
71915975|NCT05849441|143353351|SUPERIORITY|||||||0.32||||||This is for subscale: Reappraisal|Regression, Linear|||||||0.32
71915976|NCT05849441|143353351|SUPERIORITY|||||||0.24||||||This is for subscale: Suppression|Regression, Linear|||||||0.24
71915977|NCT05849441|143353352|SUPERIORITY|||||||0.53||||||This is for subscale: Manage own emotions|Regression, Linear|||||||0.53
71915978|NCT05849441|143353352|SUPERIORITY|||||||0.16||||||This is for subscale: Identify and Understand Own Emotions|Regression, Linear|||||||0.16
71915979|NCT05849441|143353352|SUPERIORITY|||||||0.27||||||This is for subscale: Deal with emotions of others|Regression, Linear|||||||0.27
71915980|NCT05849441|143353352|SUPERIORITY|||||||0.59||||||This is for subscale: Perceive emotions through faces and bodies|Regression, Linear|||||||0.59
71915981|NCT05849441|143353353|SUPERIORITY|||||||0.16|||||||Regression, Linear|||||||0.16
71915982|NCT05849441|143353354|SUPERIORITY|||||||0.65||||||This is for subscale: Fear of Negative Evaluation|Regression, Linear|||||||0.65
71915983|NCT05849441|143353354|SUPERIORITY|||||||0.6||||||This is for subscale: Social avoidance and distress (new)|Regression, Linear|||||||0.60
71915984|NCT05849441|143353354|SUPERIORITY|||||||0.23||||||This is for subscale: social avoidance and distress (general)|Regression, Linear|||||||0.23
71915985|NCT05849441|143353355|SUPERIORITY|||||||0.55|||||||Regression, Linear|||||||0.55
71915986|NCT05849441|143353356|SUPERIORITY|||||||0.11||||||This is for subscale: Negativity|Regression, Linear|||||||0.11
71915987|NCT05849441|143353356|SUPERIORITY|||||||0.79||||||This is for subscale: Emotion regulation|Regression, Linear|||||||0.79
71915988|NCT05849441|143353357|SUPERIORITY|||||||0.14||||||This is for subscale: Working Memory|Regression, Linear|||||||0.14
71874127|NCT04908189|143266425|SUPERIORITY||Adjusted mean difference|0.829|STANDARD_ERROR_OF_MEAN|0.625||0.1847|TWO_SIDED|95.0|-0.396|2.054|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||2.054|-0.396|0.1847
71915989|NCT05849441|143353357|SUPERIORITY|||||||0.2||||||This is for subscale: Planning|Regression, Linear|||||||0.20
71915990|NCT05849441|143353357|SUPERIORITY|||||||0.48||||||This is for subscale: Inhibit|Regression, Linear|||||||0.48
71915991|NCT05849441|143353357|SUPERIORITY|||||||0.37||||||This is for subscale: Regulation|Regression, Linear|||||||0.37
71915992|NCT05849441|143353358|SUPERIORITY|||||||0.45|||||||Regression, Linear|||||||0.45
71915993|NCT05849441|143353359|SUPERIORITY|||||||0.88|||||||Regression, Linear|||||||0.88
71915994|NCT03277794|143353360|OTHER||Odds Ratio (OR)|2.28|STANDARD_ERROR_OF_MEAN|0.89||0.354|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.354
71915995|NCT03277794|143353360|OTHER||Odds Ratio (OR)|2.01|STANDARD_ERROR_OF_MEAN|0.95||0.465|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.465
71915996|NCT03277794|143353361|OTHER||Odds Ratio (OR)|2.31|STANDARD_ERROR_OF_MEAN|0.59||0.159|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.159
71915997|NCT03277794|143353361|OTHER||Odds Ratio (OR)|2.3|STANDARD_ERROR_OF_MEAN|0.64||0.2|TWO_SIDED||||||Regression, Linear|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.200
71915998|NCT03277794|143353362|OTHER||Odds Ratio (OR)|3.18|STANDARD_ERROR_OF_MEAN|0.74||0.121|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.121
71915999|NCT03277794|143353362|OTHER||Odds Ratio (OR)|3.63|STANDARD_ERROR_OF_MEAN|0.85||0.134|TWO_SIDED||||||Regression, Logistic|||Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)||||0.134
71916000|NCT03277794|143353363|OTHER|||||||0.899||||||Unadjusted.|Regression, Linear|||||||0.899
71916001|NCT03277794|143353363|OTHER|||||||0.128||||||Unadjusted|Regression, Linear|||||||0.128
71916002|NCT03277794|143353364|OTHER|||||||0.198||||||Unadjusted.|Regression, Linear|||||||0.198
71916003|NCT03277794|143353364|OTHER|||||||0.017||||||Unadjusted.|Regression, Linear|||||||0.017
71916004|NCT03277794|143353365|OTHER|||||||0.091||||||Unadjusted.|Regression, Linear|||||||0.091
71916005|NCT03277794|143353365|OTHER|||||||0.591||||||Unadjusted.|Regression, Linear|||||||0.591
71916006|NCT03277794|143353366|OTHER|||||||0.03||||||Unadjusted.|Regression, Linear|||||||0.030
71916007|NCT03277794|143353366|OTHER|||||||0.005||||||Unadjusted.|Regression, Linear|||||||0.005
71916008|NCT03277794|143353367|OTHER|||||||0.163||||||Unadjusted.|Regression, Linear|||||||0.163
71916009|NCT03277794|143353367|OTHER|||||||0.865||||||Unadjusted.|Regression, Linear|||||||0.865
71916010|NCT03277794|143353368|OTHER|||||||0.98||||||Unadjusted.|Regression, Linear|||||||0.980
71916011|NCT03277794|143353368|OTHER|||||||0.758||||||Unadjusted.|Regression, Linear|||||||0.758
71916012|NCT03277794|143353369|OTHER|||||||0.124||||||Unadjusted.|Regression, Linear|||||||0.124
71916013|NCT03277794|143353369|OTHER|||||||0.168||||||Unadjusted.|Regression, Linear|||||||0.168
71916014|NCT03277794|143353370|OTHER|||||||0.436||||||Unadjusted.|Regression, Linear|||||||0.436
71916015|NCT03277794|143353370|OTHER|||||||0.706||||||Unadjusted.|Regression, Linear|||||||0.706
71916016|NCT03277794|143353371|OTHER|||||||0.604||||||Unadjusted.|Regression, Linear|||Internalizing||||0.604
71874128|NCT04908189|143266425|SUPERIORITY||Adjusted mean difference|1.145|STANDARD_ERROR_OF_MEAN|0.673||0.0888|TWO_SIDED|95.0|-0.174|2.464|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.464|-0.174|0.0888
71874129|NCT04908189|143266426|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.49||0.1924|TWO_SIDED|95.0|-1.6|0.3|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.3|-1.6|0.1924
71874130|NCT04908189|143266426|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.51||0.7601|TWO_SIDED|95.0|-1.2|0.8|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.8|-1.20|0.7601
71874131|NCT04908189|143266426|SUPERIORITY||Adjusted mean difference|1.3|STANDARD_ERROR_OF_MEAN|0.59||0.0303|TWO_SIDED|95.0|0.1|2.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||2.4|0.1|0.0303
71874132|NCT04908189|143266426|SUPERIORITY||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.63||0.4747|TWO_SIDED|95.0|-0.8|1.7|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||1.7|-0.8|0.4747
71874133|NCT04908189|143266426|SUPERIORITY||Adjusted mean difference|0.8|STANDARD_ERROR_OF_MEAN|0.61||0.2017|TWO_SIDED|95.0|-0.4|2.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||2.0|-0.4|0.2017
71874134|NCT04908189|143266428|SUPERIORITY||Adjusted mean difference|-0.077|STANDARD_ERROR_OF_MEAN|0.1015||0.4459|TWO_SIDED|95.0|-0.276|0.122|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.122|-0.276|0.4459
71874135|NCT04908189|143266428|SUPERIORITY||Adjusted mean difference|-0.232|STANDARD_ERROR_OF_MEAN|0.1164||0.0461|TWO_SIDED|95.0|-0.46|-0.004|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||-0.004|-0.460|0.0461
71874136|NCT04908189|143266428|SUPERIORITY||Adjusted mean difference|-0.598|STANDARD_ERROR_OF_MEAN|0.1321|<|0.0001|TWO_SIDED|95.0|-0.857|-0.339|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.339|-0.857|<0.0001
71874137|NCT04908189|143266428|SUPERIORITY||Adjusted mean difference|-0.605|STANDARD_ERROR_OF_MEAN|0.1416|<|0.0001|TWO_SIDED|95.0|-0.882|-0.327|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.327|-0.882|<0.0001
71874138|NCT04908189|143266428|SUPERIORITY||Adjusted mean difference|-0.786|STANDARD_ERROR_OF_MEAN|0.1455|<|0.0001|TWO_SIDED|95.0|-1.071|-0.501|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.501|-1.071|<0.0001
71874139|NCT04908189|143266429|SUPERIORITY||Adjusted mean difference|0.3525|STANDARD_ERROR_OF_MEAN|0.9227||0.7025|TWO_SIDED|95.0|-1.456|2.1609|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||2.1609|-1.4560|0.7025
71874140|NCT04908189|143266429|SUPERIORITY||Adjusted mean difference|-1.373|STANDARD_ERROR_OF_MEAN|0.93331||0.1413|TWO_SIDED|95.0|-3.2023|0.4562|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.4562|-3.2023|0.1413
71874141|NCT04908189|143266429|SUPERIORITY||Adjused mean difference|-3.7522|STANDARD_ERROR_OF_MEAN|1.10374||0.0007|TWO_SIDED|95.0|-5.9155|-1.589|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-1.5890|-5.9155|0.0007
71874142|NCT04908189|143266429|SUPERIORITY||Adjusted mean difference|-4.8072|STANDARD_ERROR_OF_MEAN|1.13857|<|0.0001|TWO_SIDED|95.0|-7.0388|-2.5757|||ANOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-2.5757|-7.0388|<0.0001
71874143|NCT04908189|143266429|SUPERIORITY||Adjusted mean difference|-6.2006|STANDARD_ERROR_OF_MEAN|1.2284|<|0.0001|TWO_SIDED|95.0|-8.6082|-3.793|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-3.7930|-8.6082|<0.0001
71874144|NCT04908189|143266433|SUPERIORITY||Adjusted mean difference|0.0318|STANDARD_ERROR_OF_MEAN|0.05613||0.5707|TWO_SIDED|95.0|-0.0782|0.1419|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 2||0.1419|-0.0782|0.5707
71874145|NCT04908189|143266433|SUPERIORITY||Adjusted mean difference|-0.0833|STANDARD_ERROR_OF_MEAN|0.06303||0.1862|TWO_SIDED|95.0|-0.2069|0.0402|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0402|-0.2069|0.1862
71874146|NCT04908189|143266433|SUPERIORITY||Adjusted mean difference|-0.2958|STANDARD_ERROR_OF_MEAN|0.07854||0.0002|TWO_SIDED|95.0|-0.4497|-0.1418|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.1418|-0.4497|0.0002
71874147|NCT04908189|143266433|SUPERIORITY||Adjusted mean difference|-0.3262|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.4889|-0.1635|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.1635|-0.4889|<0.0001
71874148|NCT04908189|143266433|SUPERIORITY||Adjusted mean difference|-0.4743|STANDARD_ERROR_OF_MEAN|0.08735|<|0.0001|TWO_SIDED|95.0|-0.6455|-0.3031|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3031|-0.6455|<0.0001
71683897|NCT02117713|142886177|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-28.59|STANDARD_DEVIATION|89.456||0.1157|TWO_SIDED|95.0|-64.72|7.54|||Student's t-test||Difference is only calculated in participants who had baseline and week 48 values for n= 26|||7.54|-64.72|0.1157
71683898|NCT02117713|142886178|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant; null hypothesis is that the mean change from baseline is equal to zero.|Mean Difference (Net)|-45.15|STANDARD_DEVIATION|89.934||0.1469|TWO_SIDED|95.0|-109.48|19.19|||Student's t-test||||Difference is only calculated in participants who had baseline and week 216 values for n=10|19.19|-109.48|0.1469
71683899|NCT02117713|142886179|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-2.353|STANDARD_DEVIATION|0.7124||0.005|TWO_SIDED|95.0|-3.101|-1.606|||Student's t-test||Difference is only calculated in participants who had baseline and week 218 values for n=6|||-1.606|-3.101|0.005
71683900|NCT02117713|142886180|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|56.0|STANDARD_DEVIATION|119.32||0.2607|TWO_SIDED|95.0|-54.4|166.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||166.4|-54.4|0.2607
71683901|NCT02117713|142886181|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-141.6|STANDARD_DEVIATION|216.25||0.134|TWO_SIDED|95.0|-341.6|58.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||58.4|-341.6|0.1340
71683902|NCT02117713|142886182|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|47.6|STANDARD_DEVIATION|75.68||0.1474|TWO_SIDED|95.0|-22.4|117.6|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||117.6|-22.4|0.1474
71683903|NCT02117713|142886183|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.0|STANDARD_DEVIATION|0.58||1|TWO_SIDED|95.0|-0.5|0.5|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.5|-0.5|1.00
71683904|NCT02117713|142886184|EQUIVALENCE|Student's t-test used to test if mean change is statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-1.7|STANDARD_DEVIATION|1.38||0.0167|TWO_SIDED|95.0|-3.0|-0.4|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||-0.4|-3|0.0167
71916017|NCT03277794|143353371|OTHER|||||||0.177||||||Unadjusted.|Regression, Linear|||Internalizing||||0.177
71916018|NCT03277794|143353371|OTHER|||||||0.325||||||Unadjusted.|Regression, Linear|||Externalizing||||0.325
71916019|NCT03277794|143353371|OTHER|||||||0.227||||||Unadjusted.|Regression, Linear|||Externalizing||||0.227
71916020|NCT03277794|143353371|OTHER|||||||0.106||||||Unadjusted.|Regression, Linear|||Substance Use||||0.106
71916021|NCT03277794|143353371|OTHER|||||||0.058||||||Unadjusted.|Regression, Linear|||Substance Use||||0.058
71916022|NCT03277794|143353372|OTHER|||||||0.862||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.862
71916023|NCT03277794|143353372|OTHER|||||||0.382||||||Unadjusted.|Regression, Linear|||Emotional Supports||||0.382
71916024|NCT03277794|143353372|OTHER|||||||0.68||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.680
71916025|NCT03277794|143353372|OTHER|||||||0.988||||||Unadjusted.|Regression, Linear|||Tangible Supports||||0.988
71916026|NCT03277794|143353372|OTHER|||||||0.701||||||Unadjusted.|Regression, Linear|||Affectionate||||0.701
71916027|NCT03277794|143353372|OTHER|||||||0.154||||||Unadjusted.|Regression, Linear|||Affectionate||||0.154
71916028|NCT03277794|143353373|OTHER|||||||0.719||||||Unadjusted.|Regression, Linear|||Physical Health||||0.719
71916029|NCT03277794|143353373|OTHER|||||||0.15||||||Unadjusted.|Regression, Linear|||Physical Health||||0.150
71916030|NCT03277794|143353373|OTHER|||||||0.789||||||Unadjusted.|Regression, Linear|||Psychological||||0.789
71916031|NCT03277794|143353373|OTHER|||||||0.811||||||Unadjusted.|Regression, Linear|||Psychological||||0.811
71916032|NCT03277794|143353373|OTHER|||||||0.726||||||Unadjusted.|Regression, Linear|||Social||||0.726
71916033|NCT03277794|143353373|OTHER|||||||0.795||||||Unadjusted.|Regression, Linear|||Social||||0.795
71916034|NCT03277794|143353373|OTHER|||||||0.837||||||Unadjusted.|Regression, Linear|||Environment||||0.837
71916035|NCT03277794|143353373|OTHER|||||||0.048||||||Unadjusted.|Regression, Linear|||Environment||||0.048
71916036|NCT03399786|143353430|SUPERIORITY||Least Squares (LS) Mean Difference|-49.0|STANDARD_ERROR_OF_MEAN|8.0|<|0.0001|TWO_SIDED|95.0|-65.0|-33.1|||Mixed-effect Model Repeat Measure (MMRM)|||Confidence interval (CI) with p-value was based on-treatment group difference of least squares (LS) means using mixed-effect model repeat measurement (MMRM), randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-33.1|-65.0|< 0.0001
71874149|NCT04908189|143266436|SUPERIORITY||Adjusted mean difference|-0.0758|STANDARD_ERROR_OF_MEAN|0.07069||0.2836|TWO_SIDED|95.0|-0.2144|0.0627|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.0627|-0.2144|0.2836
71874150|NCT04908189|143266436|SUPERIORITY||Adjusted mean difference|-0.5548|STANDARD_ERROR_OF_MEAN|0.09431|<|0.0001|TWO_SIDED|95.0|-0.7396|-0.3699|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.3699|-0.7396|<0.0001
71874151|NCT04908189|143266436|SUPERIORITY||Adjusted mean difference|-0.5835|STANDARD_ERROR_OF_MEAN|0.10162|<|0.0001|TWO_SIDED|95.0|-0.7826|-0.3843|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.3843|-0.7826|<0.0001
71874152|NCT04908189|143266437|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.2143|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.1|-0.4|0.2143
71874153|NCT04908189|143266437|SUPERIORITY||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.13||0.0001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 8||-0.2|-0.8|0.0001
71874154|NCT04908189|143266437|SUPERIORITY||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.0|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||-0.4|-1.0|<0.0001
71874155|NCT04908189|143266437|SUPERIORITY||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||-0.4|-0.9|<0.0001
71874156|NCT04908189|143266440|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|1.801||0.8316|TWO_SIDED|95.0|-3.91|3.15|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Absenteeism||3.15|-3.91|0.8316
71874157|NCT04908189|143266440|SUPERIORITY||Adjusted mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.827||0.106|TWO_SIDED|95.0|-6.54|0.63|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Presenteeism||0.63|-6.54|0.1060
71874158|NCT04908189|143266440|SUPERIORITY||Adjusted mean difference|-2.71|STANDARD_ERROR_OF_MEAN|1.918||0.1578|TWO_SIDED|95.0|-6.47|1.05|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Work Productivity||1.05|-6.47|0.1578
71874159|NCT04908189|143266440|SUPERIORITY||Adjusted mean difference|-7.59|STANDARD_ERROR_OF_MEAN|1.719|<|0.0001|TWO_SIDED|95.0|-10.96|-4.22|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Activity Impairment||-4.22|-10.96|<0.0001
71874160|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|-0.0026|STANDARD_ERROR_OF_MEAN|0.01224||0.8487|TWO_SIDED|95.0|-0.0291|0.0239|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Utility Score||0.0239|-0.0291|0.8487
71874161|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|0.0365|STANDARD_ERROR_OF_MEAN|0.01531||0.0171|TWO_SIDED|95.0|0.0065|0.0665|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Utility Score||0.0665|0.0065|0.0171
71874162|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.9254|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Mobility||0.1|-0.1|0.9254
71874163|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0566|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Mobility||0.0|-0.2|0.0566
71874164|NCT04908189|143266441|SUPERIORITY||Ajudted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.8933|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Self-Care||0.1|-0.1|0.8933
71874165|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0738|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Self-Care||0.0|-0.2|0.0738
71874166|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6176|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Usual Activities||0.1|-0.1|0.6176
71874167|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1544|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Usual Activities||0.0|-0.2|0.1544
71683905|NCT02117713|142886185|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|10.9|STANDARD_DEVIATION|245.92||0.9108|TWO_SIDED|95.0|-216.6|238.3|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||238.3|-216.6|0.9108
71683906|NCT02117713|142886186|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant(null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|0.1207|STANDARD_DEVIATION|1.882||0.1207|TWO_SIDED|95.0|-3.03|0.45|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.45|-3.03|0.1207
71683907|NCT02117713|142886187|EQUIVALENCE|Student's t-test was used to test if mean change was statistically significant (null hypothesis is that the mean change from baseline is equal to zero).|Mean Difference (Net)|-0.943|STANDARD_DEVIATION|1.2488||0.0927|TWO_SIDED|95.0|-2.098|0.212|||Student's t-test||Difference is only calculated in participants who had baseline and week 216 values for n=7|||0.212|-2.098|0.0927
71683908|NCT00432276|142886221|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.47|||||ONE_SIDED|97.5||-0.35|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.||-0.35||
71916037|NCT03399786|143353431|SUPERIORITY||Least Squares (LS) Mean Difference|-36.9|STANDARD_ERROR_OF_MEAN|5.9|<|0.0001|TWO_SIDED|95.0|-48.6|-25.2|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated Apo B value.||-25.2|-48.6|< 0.0001
71916038|NCT03399786|143353432|SUPERIORITY||Least Squares (LS) Mean Difference|-51.7|STANDARD_ERROR_OF_MEAN|6.6|<|0.0001|TWO_SIDED|95.0|-64.8|-38.5|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated non-HDL-C value.||-38.5|-64.8|< 0.0001
71916039|NCT03399786|143353433|SUPERIORITY||Least Squares (LS) Mean Difference|-48.4|STANDARD_ERROR_OF_MEAN|5.1|<|0.0001|TWO_SIDED|95.0|-58.7|-38.1|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated TC value.||-38.1|-58.7|< 0.0001
71916040|NCT03399786|143353434|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|25.2|||<|0.0001|TWO_SIDED|95.0|5.7|110.5|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||110.5|5.7|< 0.0001
71916041|NCT03399786|143353435|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|24.2|||=|0.0028|TWO_SIDED|95.0|3.0|195.6|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for secondary endpoints in pre-specified order to control type I error.Testing sequence continued only when previous endpoint was statistically significant at 0.05.Multiple imputation addressed missing data at week 24.Combined estimate for odds ratio obtained by Rubin's formulae.Logistic regression models stratified by randomized strata include fixed categorical effect of treatment group \& continuous fixed covariate of baseline calculated LDL-C.||195.6|3.0|= 0.0028
71683909|NCT00432276|142886221|NON_INFERIORITY_OR_EQUIVALENCE|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.42|||||ONE_SIDED|97.5||-0.28|||ANCOVA||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Comparison of Change from Baseline at Week 52. The null hypothesis was that the average change from Baseline in HbA1c at Week 52 for the alogliptin 25 mg addition group is inferior to the average change for the pioglitazone titration group. The alternative hypothesis was that the change from Baseline in HbA1c for the alogliptin 25 mg addition group was non-inferior to the change for the pioglitazone titration group for at Week 52.||-0.28||
71683910|NCT00432276|142886222|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.44|||<|0.001|TWO_SIDED|95.0|-0.57|-0.31||Statistical tests and resulting P-values are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.||Comparison of change from Baseline in HbA1c at Week 42.||-0.31|-0.57|<0.001
71916042|NCT03399786|143353436|SUPERIORITY||Least Squares (LS) Mean Difference|-132.1|STANDARD_ERROR_OF_MEAN|21.5|<|0.0001|TWO_SIDED|95.0|-175.3|-88.9|||Mixed-effect Model Repeat Measure (MMRM)|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. CI with p-value was based on-treatment group difference of LS means using MMRM, randomization strata, treatment/strata/baseline value-by-time point interaction and continuous fixed covariates of baseline calculated LDL-C value.||-88.9|-175.3|< 0.0001
71916043|NCT03399786|143353437|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0845|TWO_SIDED|95.0|0.0|1.3|||Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||1.3|0|= 0.0845
71916044|NCT03399786|143353438|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|5.7|||=|0.0203|TWO_SIDED|95.0|1.3|24.9||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analyses|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||24.9|1.3|= 0.0203
71916045|NCT03399786|143353439|SUPERIORITY|A 2-step multiple imputation method addressed missing values (seeds = 1629 \& 9261 with number of imputations = 100 in first and number of imputation=1 in second step).|Odds Ratio (OR)|0.1|||=|0.0004|TWO_SIDED|95.0|0.0|0.3||The p-value is nominal for descriptive purpose only due to statistical hypothesis testing terminated previously.|Logistic Regression Models Analysis|||A 2-sided hierarchical testing procedure was used for the secondary endpoints in a pre-specified order to control type I error. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Combined estimate for odds ratio was obtained by using Rubin's formulae. Logistic regression models stratified the fixed categorical effect of treatment group and the continuous fixed covariate of baseline calculated LDL-C value.||0.3|0.0|= 0.0004
71916046|NCT00400946|143353505|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||.60
71916047|NCT01673373|143353524|OTHER|Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.|||||<|0.0001||||||The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.|one-sided exact|||The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.|"The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.~An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%."|||<.0001
71916048|NCT01673373|143353525|OTHER|A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.||||||0.0192||||||The defined threshold for statistical significance is .025.|t-test, 1 sided|||The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.||||.0192
71916049|NCT04852666|143353537|SUPERIORITY|||||||0.751|||||||t-test, 2 sided|||||||0.751
71916050|NCT04852666|143353537|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
71916051|NCT04852666|143353538|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
71916052|NCT04852666|143353538|SUPERIORITY|||||||0.357|||||||t-test, 2 sided|||||||0.357
71916053|NCT04852666|143353539|SUPERIORITY|||||||0.012|||||||Chi-squared|||||||0.012
71916054|NCT04852666|143353539|SUPERIORITY|||||||0.956|||||||Chi-squared|||||||0.956
71916055|NCT04852666|143353540|SUPERIORITY|||||||0.103|||||||Chi-squared|||||||0.103
71916056|NCT04852666|143353540|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71916057|NCT04852666|143353541|SUPERIORITY|||||||0.785|||||||t-test, 2 sided|||||||0.785
71916058|NCT04852666|143353542|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.200
71916059|NCT04852666|143353543|SUPERIORITY|||||||0.887|||||||t-test, 2 sided|||||||0.887
71916060|NCT04852666|143353543|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71916061|NCT05426460|143353544|SUPERIORITY|||||||0.438|||||||ANOVA|||2 x 2 ANOVA||||.438
71916062|NCT05426460|143353545|SUPERIORITY|||||||0.847|||||||ANOVA|||2 x 2 ANOVA||||.847
71916063|NCT05426460|143353546|SUPERIORITY|||||||0.57|||||||ANOVA|||2 X 2 ANOVA||||.570
71916064|NCT05426460|143353547|SUPERIORITY|||||||0.657|||||||ANOVA|||2 x 2 ANOVA||||.657
71916065|NCT05426460|143353548|SUPERIORITY|||||||0.254|||||||ANOVA|||2 x 2 ANOVA||||.254
71916066|NCT05426460|143353549|SUPERIORITY|||||||0.852|||||||ANOVA|||2 x 2 ANOVA with Main effect p-values for tDCS and AAT reported in comments below||||.852
71916067|NCT05426460|143353550|SUPERIORITY|||||||0.732|||||||ANOVA|||2 x 2 ANOVA||||.732
71916068|NCT05426460|143353551|SUPERIORITY|||||||0.038|||||||ANOVA|||2 x 2 ANOVA||||.038
71916069|NCT05426460|143353552|SUPERIORITY|||||||0.029|||||||ANOVA|||2 x 2 ANOVA||||.029
71916070|NCT05426460|143353553|SUPERIORITY|||||||0.353|||||||ANOVA|||2 x 2 ANOVA||||.353
71916071|NCT01431521|143353557|SUPERIORITY_OR_OTHER||Least squares mean difference|-44.37|||<|0.001|TWO_SIDED|95.0|-54.67|-34.07|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-34.07|-54.67|<0.001
71916072|NCT01431521|143353557|SUPERIORITY_OR_OTHER||Least squares mean difference|-26.67|||<|0.001|TWO_SIDED|95.0|-36.97|-16.37|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-16.37|-36.97|<0.001
71916073|NCT01431521|143353557|SUPERIORITY_OR_OTHER||least squares mean difference|-17.69||||0.007|TWO_SIDED|95.0|-36.97|-7.39|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate||||-7.39|-36.97|0.007
71916074|NCT01431521|143353558|SUPERIORITY_OR_OTHER||Least square mean difference|-6.35|||>|0.2|TWO_SIDED|95.0|-18.69|6.0|||Linear mixed effect model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||6.00|-18.69|>0.200
71916075|NCT01431521|143353558|SUPERIORITY_OR_OTHER||Least squares mean difference|-16.74||||0.028|TWO_SIDED|95.0|-29.08|-4.4|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||-4.40|-29.08|0.028
71916076|NCT01431521|143353559|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.47|||>|0.2|TWO_SIDED|95.0|-17.85|10.92|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||10.92|-17.85|>0.200
71916077|NCT01431521|143353559|SUPERIORITY_OR_OTHER||Least squares mean difference|-10.67|||>|0.2|TWO_SIDED|95.0|-25.06|3.71|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate||||3.71|-25.06|>0.200
71916078|NCT05171816|143353580|OTHER|Exploratory|Hazard Ratio (HR)|1.43||||0.2592|TWO_SIDED|95.0|0.83|2.48||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.48|0.83|0.2592
71916079|NCT05171816|143353581|OTHER|Exploratory|Hazard Ratio (HR)|1.14||||0.7251|TWO_SIDED|95.0|0.57|2.29||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.29|0.57|0.7251
71916080|NCT05171816|143353582|OTHER|Exploratory|Hazard Ratio (HR)|0.99||||0.9715|TWO_SIDED|95.0|0.6|1.64||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||1.64|0.60|0.9715
71916081|NCT05171816|143353583|OTHER|Exploratory|Hazard Ratio (HR)|0.68||||0.4937|TWO_SIDED|95.0|0.2|2.06||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||2.06|0.20|0.4937
71916082|NCT05171816|143353584|OTHER|Exploratory|Hazard Ratio (HR)|1.65||||0.4923|TWO_SIDED|95.0|0.61|4.87||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||4.87|0.61|0.4923
71916083|NCT05171816|143353586|OTHER|Exploratory|Hazard Ratio (HR)|1.45||||0.3407|TWO_SIDED|95.0|0.63|3.39||Nominal p-value|Log Rank|The 2-sided p-value was calculated using the log-rank test stratified by metastases.|HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.|||3.39|0.63|0.3407
71916084|NCT02000622|143353608|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0009|TWO_SIDED|95.0|0.43|0.8||A priori threshold for statistical significance (2-sided) is 0.05.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.||0.80|0.43|0.0009
71916085|NCT02000622|143353609|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0033|TWO_SIDED|95.0|0.4|0.83||PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.83|0.40|0.0033
71916086|NCT02000622|143353610|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5665|TWO_SIDED|95.0|0.63|1.29||OS tested using a multiple testing procedure with a recycling strategy. With 140 OS events, a priori threshold for statistical significance (2-sided) was 0.018.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.29|0.63|0.5665
71916087|NCT02000622|143353612|SUPERIORITY||Mean Difference (Final Values)|7.5||||0.0035|TWO_SIDED|95.0|2.5|12.4|||Mixed Models Analysis|Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.|Mean difference \>0 favours olaparib.|||12.4|2.5|0.0035
71916088|NCT02000622|143353613|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0005|TWO_SIDED|95.0|0.41|0.78|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||0.78|0.41|0.0005
71916089|NCT02000622|143353614|SUPERIORITY||Hazard Ratio (HR)|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.47|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.47|0.24|<0.0001
71916090|NCT02000622|143353615|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.0002|TWO_SIDED|95.0|0.38|0.74|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.74|0.38|0.0002
71916091|NCT02000622|143353616|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.5131|TWO_SIDED|95.0|0.66|1.23||OS tested using a multiple testing procedure with a recycling strategy. With 192 OS events, a priori threshold for statistical significance was 0.045.|Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.23|0.66|0.5131
71916092|NCT02000622|143353617|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.4167|TWO_SIDED|95.0|0.67|1.18|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|||1.18|0.67|0.4167
71916093|NCT02000622|143353618|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.27|0.5|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS.||0.50|0.27|<0.0001
71916094|NCT02000622|143353619|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.4|0.72|||Log Rank|Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio \<1 favours olaparib.|Supportive analysis to PFS2.||0.72|0.40|<0.0001
71916095|NCT01405027|143353620|SUPERIORITY_OR_OTHER|||||||0.4864|TWO_SIDED||||||ANOVA|||||||0.4864
71916096|NCT05085327|143353626|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Original: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
71916097|NCT05085327|143353626|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Mint: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
71916098|NCT05085327|143353626|OTHER|The t value from the '2-sided' Student-t distribution table corresponding to the upper 5% point with n-1 degrees of freedom was obtained and the labeled SPF value was determined as the largest whole number less than the following calculation: Labeled SPF = Mean SPF - (t\*SE).|CLM Black Cherry: Labeled SPF|13.0|||||TWO_SIDED|||||||||||||
71916099|NCT01320033|143353627|SUPERIORITY||Mean Difference (Final Values)|-3.6||||0.006|TWO_SIDED|95.0|-6.1|-1.1|||ANCOVA|||||-1.1|-6.1|0.006
71916100|NCT01320033|143353627|SUPERIORITY||Mean Difference (Final Values)|-2.9||||0.024|TWO_SIDED|95.0|-5.4|-0.4|||ANCOVA|||||-0.4|-5.4|0.024
71916101|NCT01320033|143353627|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.595|TWO_SIDED|95.0|-3.2|1.8|||ANCOVA|||||1.8|-3.2|0.595
71916102|NCT01250899|143353653|SUPERIORITY_OR_OTHER||Percentage of 12-wk 25(OH)D ≥30ng/mL|70.0|||<|0.05|TWO_SIDED|95.0|60.0|80.0|||Exact binomial||The primary endpoint (mean change in 25(OH)D following 12 weeks of vitamin D repletion in vitamin D insufficient subjects) was dichotomized to success or failure to achieve a week twelve 25(OH)D level ≥30ng/mL.|We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).||80|60|<0.05
71916103|NCT02234050|143353661|SUPERIORITY||Hazard Ratio (HR)|1.42||||0.204|TWO_SIDED|80.0|0.997|2.028|||Regression, Cox|||||2.028|0.997|0.204
71916104|NCT02234050|143353664|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.94|TWO_SIDED|95.0|0.53|1.71|||Regression, Cox|||||1.71|0.53|0.94
71874168|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.4707|TWO_SIDED|95.0|-0.2|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Pain/Discomfort||0.1|-0.2|0.4707
71874169|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0114|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Pain/Discomfort||0.0|-0.3|0.0114
71874170|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.6594|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4 Anxiety/Depression||0.1|-0.1|0.6594
71874171|NCT04908189|143266441|SUPERIORITY||Adjusted mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.06||0.7123|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16 Anxiety/Depression||0.1|-0.1|0.7123
71874172|NCT04908189|143266442|SUPERIORITY||Adjusted mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.498||0.9834|TWO_SIDED|95.0|-0.99|0.97|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 4||0.97|-0.99|0.9834
71874173|NCT04908189|143266442|SUPERIORITY||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.565||0.6099|TWO_SIDED|95.0|-1.39|0.82|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 12||0.82|-1.39|0.6099
71916105|NCT02365506|143353666|SUPERIORITY||Difference in LSM|-7.7|STANDARD_ERROR_OF_MEAN|7.92||0.358|TWO_SIDED|95.0|-26.0|10.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|Least Square mean (LSM) and 95% confidence interval (CI) is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||10.5|-26.0|0.358
71683911|NCT00432276|142886230|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9|||<|0.001|TWO_SIDED|95.0|-16.2|-5.7||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and FPG as covariates.||Comparison of change from Baseline at Week 52.||-5.7|-16.2|<0.001
71874174|NCT04908189|143266442|SUPERIORITY||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.538||0.2205|TWO_SIDED|95.0|-1.71|0.4|||ANCOVA||The adjusted mean difference and p-value are based on the total randomized population, which is 312 for Deucravacitinib and 312 for Placebo|Week 16||0.40|-1.71|0.2205
71874175|NCT02083705|143266456|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||"We hypothesised that during neonatal CPR, CC+SI will reduce the time needed to achieve ROSC. Our aim was to examine if CC+SI reduces ROSC compared with 3:1 C:V CPR in preterm infants \<33 weeks of gestation.~For this pilot study, based on the local incidence of CPR in preterm neonates, a convenient sample size of five patients per group was enrolled. Our primary outcome was time to achieve ROSC measured using ECG."||||0.05
71683912|NCT00432276|142886231|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of marked hyperglycemia through Week 52.||||<0.001
71874176|NCT01839487|143266465|OTHER||Hazard Ratio (HR)|0.74||||0.058|TWO_SIDED|95.0|0.54|1.01||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the Karnofsky Performance Status (KPS) category (70-80% and 90-100%) at screening using AG as the reference arm.||1.01|0.54|0.058
71683913|NCT00432276|142886232|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of hyperglycemic rescue through Week 52.||||<0.001
71683914|NCT00432276|142886233|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.6||||0.116|TWO_SIDED|95.0|-3.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and proinsulin as covariates.||Comparison of change from Baseline at Week 52.||0.4|-3.7|0.116
71683915|NCT00432276|142886234|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73||||0.276|TWO_SIDED|95.0|-0.58|2.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and fasting insulin as covariates.||Comparison of change from Baseline at Week 52.||2.04|-0.58|0.276
71874177|NCT01839487|143266467|OTHER||Hazard Ratio (HR)|0.57||||0.092|TWO_SIDED|95.0|0.3|1.1||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-high was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.10|0.30|0.092
71683916|NCT00432276|142886235|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.041|||<|0.001|TWO_SIDED|95.0|-0.063|-0.018||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as covariates.||Comparison of change from Baseline at Week 52.||-0.018|-0.063|<0.001
71683917|NCT00432276|142886236|SUPERIORITY_OR_OTHER||LS Mean Difference|0.073||||0.23|TWO_SIDED|95.0|-0.047|0.193||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.||Comparison of change from Baseline at Week 52.||0.193|-0.047|0.230
71683918|NCT00432276|142886237|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188||||0.567|TWO_SIDED|95.0|-0.83|0.455||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates.||Comparison of change from Baseline at Week 52.||0.455|-0.830|0.567
71683919|NCT00432276|142886238|SUPERIORITY_OR_OTHER||LS Mean Difference|12.963|||<|0.001|TWO_SIDED|95.0|5.333|20.592||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates.||Comparison of change from Baseline at Week 52.||20.592|5.333|<0.001
71916106|NCT02365506|143353666|SUPERIORITY||Difference in LSM|-1.7|STANDARD_ERROR_OF_MEAN|7.96||0.84|TWO_SIDED|95.0|-20.0|16.7|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||16.7|-20.0|0.840
71683920|NCT00432276|142886239|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.071|TWO_SIDED|95.0|-1.03|0.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.||Comparison of change from Baseline at Week 52.||0.04|-1.03|0.071
71916107|NCT02365506|143353667|SUPERIORITY||Difference in LSM|-6.0|STANDARD_ERROR_OF_MEAN|5.83||0.338|TWO_SIDED|95.0|-19.8|7.8|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||7.8|-19.8|0.338
71916108|NCT02365506|143353667|SUPERIORITY||Difference in LSM|5.3|STANDARD_ERROR_OF_MEAN|6.21||0.425|TWO_SIDED|95.0|-9.4|19.9|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||19.9|-9.4|0.425
71683921|NCT00432276|142886240|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.2||||0.058|TWO_SIDED|95.0|-8.6|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.1|-8.6|0.058
71874178|NCT01839487|143266467|OTHER||Hazard Ratio (HR)|0.88||||0.514|TWO_SIDED|95.0|0.59|1.31||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG for HA-low was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.31|0.59|0.514
71874179|NCT01839487|143266468|OTHER||Risk Ratio (RR)|1.22||||0.225|TWO_SIDED|95.0|0.88|1.68||Threshold for significance at 0.1 level.|Cochran-Mantel-Haenszel|||p-Value and relative risk were based on a stratified Cochran-Mantel-Haenszel method using KPS category at screening as the stratification factor.||1.68|0.88|0.225
71874180|NCT01839487|143266469|OTHER||Hazard Ratio (HR)|0.91||||0.495|TWO_SIDED|95.0|0.7|1.19||Threshold for significance at 0.1 level.|Log Rank|P-value was based on stratified log-rank test with the KPS category at screening as the stratification factor.||Hazard ratio PAG/AG was based on Cox proportional hazards model stratified by the KPS category (70-80% and 90-100%) at screening using AG as the reference arm.||1.19|0.70|0.495
71874181|NCT00475033|143266477|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.4|||||TWO_SIDED|95.0|-5.3|-0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||-0.1|-5.3|
71874182|NCT00475033|143266478|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Ratio of GMs (13vPnC, 7vPnC)||1.48|0.96|
71874183|NCT00475033|143266479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.6|1.7|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.7|-1.6|
71874184|NCT00475033|143266479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.3|-1.3|
71874185|NCT00475033|143266479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|1.1|||||TWO_SIDED|95.0|-1.7|4.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||4.2|-1.7|
71874186|NCT00475033|143266479|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-2.1|||||TWO_SIDED|95.0|-5.5|1.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage||1.2|-5.5|
71874187|NCT00475033|143266480|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||1.4|-1.4|
71874188|NCT00475033|143266481|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.27|||||TWO_SIDED|95.0|1.08|1.5|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)||1.50|1.08|
71874189|NCT00475033|143266486|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.14|||||TWO_SIDED|95.0|1.02|1.27|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PT: Ratio of geometric means (13vPnC, 7vPnC)||1.27|1.02|
71874190|NCT00475033|143266486|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.12|||||TWO_SIDED|95.0|1.01|1.25|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FHA: Ratio of geometric means (13vPnC, 7vPnC)||1.25|1.01|
71916109|NCT02365506|143353668|SUPERIORITY||Difference in LSM|-6.5|STANDARD_ERROR_OF_MEAN|4.42||0.174|TWO_SIDED|95.0|-16.5|3.5|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||3.5|-16.5|0.174
71916110|NCT02365506|143353668|SUPERIORITY||Difference in LSM|3.4|STANDARD_ERROR_OF_MEAN|4.28||0.448|TWO_SIDED|95.0|-6.3|13.1|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||13.1|-6.3|0.448
71683922|NCT00432276|142886241|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.228|TWO_SIDED|95.0|-1.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.4|-1.7|0.228
71874191|NCT00475033|143266486|SUPERIORITY_OR_OTHER||Ratio of geometric means|1.05|||||TWO_SIDED|95.0|0.89|1.24|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRN: Ratio of geometric means (13vPnC, 7vPnC)||1.24|0.89|
71874192|NCT00475033|143266486|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.89|||||TWO_SIDED|95.0|0.78|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FIM: Ratio of geometric means (13vPnC, 7vPnC)||1.02|0.78|
71916111|NCT02365506|143353669|SUPERIORITY||Difference in LSM|8.8|STANDARD_ERROR_OF_MEAN|8.5||0.339|TWO_SIDED|95.0|-12.0|29.6|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||29.6|-12.0|0.339
71874193|NCT00475033|143266487|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-1.8|||||TWO_SIDED|95.0|-4.4|0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||0.1|-4.4|
71874194|NCT00475033|143266488|SUPERIORITY_OR_OTHER||Ratio of geometric means|0.91|||||TWO_SIDED|95.0|0.75|1.12|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)||1.12|0.75|
71874195|NCT00475033|143266489|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was \> -10%.|Difference|-3.0|||||TWO_SIDED|95.0|-9.4|3.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.||3.4|-9.4|
71874196|NCT03444324|143266512|NON_INFERIORITY|The primary efficacy analysis of this endpoint was to test non-inferiority in the Per-protocol Set. The final analysis was performed using a two-way analysis of variance (ANOVA). Non-inferiority was to be demonstrated if the upper confidence limit of the two-sided 95 % confidence interval (CI) for the difference in the least squares mean (LSM) was less than the non-inferiority margin (150 mL).|Difference in LSM|-279.43|||<|0.001|TWO_SIDED|95.0|-552.38|-6.48||p-value from Van Elteren test, stratified by predictive blood loss (\> 1,000 mL to = 2,000 mL and \>2,000 mL)|Van Elteren test|||||-6.48|-552.38|<0.001
71874197|NCT03444324|143266513|OTHER||Difference in response rate|38.1|||<|0.001|TWO_SIDED|95.0|26.0|50.3|||Cochran-Mantel-Haenszel|P-value is from a Cochran-Mantel-Haenszel model stratified by predictive blood loss (\> 1,000 mL to ≤ 2,000 mL and \> 2,000 mL).||||50.3|26|<0.001
71874198|NCT03444324|143266514|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71874199|NCT03444324|143266520|OTHER||Difference in LSM|-15.5|||<|0.831|TWO_SIDED|95.0|-157.83|126.88|||ANOVA|||||126.88|-157.83|<0.831
71874200|NCT03444324|143266521|OTHER||Difference in LSM|12.4|||=|0.809|TWO_SIDED|95.0|-88.84|113.66|||ANOVA|||||113.66|-88.84|=0.809
71874201|NCT03444324|143266522|OTHER||Difference in proportion|-4.8|||=|0.022|TWO_SIDED|95.0|-8.9|-0.7|||Cochran-Mantel-Haenszel|||||-0.7|-8.9|=0.022
71874202|NCT02525861|143266539|OTHER||Geometric Mean Ratio|5.398|||<|0.001|||||||Mixed-effects model|||Statistical analysis was collected and assessed based on A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
71874203|NCT02525861|143266540|OTHER||Geometric Mean Ratio|2.259|||<|0.001|||||||mixed-effects model|||Statistical analysis was collected and assessed based on functional A1P1 Levels at baseline and On-treatment BAL visit.||||<0.001
71874204|NCT04796896|143266563|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if:~The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.224|||||TWO_SIDED|95.0|1.061|1.413||||||||1.413|1.061|
71874205|NCT04796896|143266564|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|0.995|||||TWO_SIDED|95.0|0.87|1.139||||||||1.139|0.870|
71874206|NCT04796896|143266564|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|1.257|||||TWO_SIDED|95.0|1.101|1.434||||||||1.434|1.101|
71874207|NCT04796896|143266565|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.3|||||TWO_SIDED|95.0|-2.2|1.6||||||||1.6|-2.2|
71874208|NCT04796896|143266566|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|-0.4|||||TWO_SIDED|95.0|-2.5|1.5||||||||1.5|-2.5|
71874209|NCT04796896|143266566|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-0.8|2.4||||||||2.4|-0.8|
71874210|NCT04796896|143266567|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.897|||||TWO_SIDED|95.0|3.158|4.808||||||||4.808|3.158|
71874211|NCT04796896|143266567|NON_INFERIORITY|"The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true:~The lower bound of the 95% CI of the GMR was \>0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold)."|GMR|3.982|||||TWO_SIDED|95.0|3.404|4.657||||||||4.657|3.404|
71874212|NCT04796896|143266569|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-4.4|2.4||||||||2.4|-4.4|
71683923|NCT00432276|142886242|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8||||0.132|TWO_SIDED|95.0|-6.5|0.9||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.||0.9|-6.5|0.132
71683924|NCT00432276|142886243|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.6||||0.08|TWO_SIDED|95.0|-18.3|1.0||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.||Comparison of change from Baseline at Week 52.||1.0|-18.3|0.080
71916112|NCT02365506|143353669|SUPERIORITY||Difference in LSM|12.8|STANDARD_ERROR_OF_MEAN|8.4||0.178|TWO_SIDED|95.0|-7.7|33.4|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||33.4|-7.7|0.178
71916113|NCT02365506|143353670|SUPERIORITY||Difference in LSM|4.9|STANDARD_ERROR_OF_MEAN|8.03||0.564|TWO_SIDED|95.0|-14.1|23.9|||Mixed Models Analysis|||||23.9|-14.1|0.564
71916114|NCT02365506|143353670|SUPERIORITY||Difference in LSM|2.7|STANDARD_ERROR_OF_MEAN|7.38||0.721|TWO_SIDED|95.0|-14.7|20.2|||Mixed Models Analysis|p-value is from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|LSM and 95% CI are from a mixed model with fixed effect for treatment, day, and treatment by day with baseline daytime QTcF as a covariate.|||20.2|-14.7|0.721
71916115|NCT00592176|143353674|SUPERIORITY_OR_OTHER|||||||0.83|||||||t-test, 2 sided|||||||0.83
71683925|NCT00432276|142886244|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0314||||0.059|TWO_SIDED|95.0|-0.064|0.0012||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as covariates.||Comparison of change from Baseline at Week 52.||0.0012|-0.0640|0.059
71916116|NCT03728881|143353681|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.5|||||TWO_SIDED|96.0|0.44|0.57|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.57|0.44|
71916117|NCT03728881|143353683|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|Ratio of the GMCs|1.11|||||TWO_SIDED|96.0|0.95|1.29|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.95|
71916118|NCT03728881|143353685|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.36|0.5|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.50|0.36|
71874213|NCT04796896|143266569|NON_INFERIORITY|The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was \>-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).|percentage difference|0.7|||||TWO_SIDED|95.0|-2.2|2.4||||||||2.4|-2.2|
71874214|NCT04796896|143266578|OTHER|The 95% confidence interval (CI) of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.706|||||TWO_SIDED|95.0|0.325|0.873|||||Vaccine efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.873|0.325|
71874215|NCT04796896|143266578|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.409|||||TWO_SIDED|95.0|0.287|0.509|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.509|0.287|
71874216|NCT04796896|143266578|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.324|||||TWO_SIDED|95.0|0.127|0.474|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.474|0.127|
71874217|NCT04796896|143266579|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.683|||||TWO_SIDED|95.0|0.151|0.882|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.882|0.151|
71874218|NCT04796896|143266579|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.281|||||TWO_SIDED|95.0|-0.007|0.48|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.480|-0.007|
71874219|NCT04796896|143266579|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|-0.068|||||TWO_SIDED|95.0|-0.832|0.352|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.352|-0.832|
71874220|NCT04796896|143266580|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.76|||||TWO_SIDED|95.0|-0.416|0.965|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.965|-0.416|
71874221|NCT04796896|143266580|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.466|||||TWO_SIDED|95.0|0.328|0.574|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.574|0.328|
71874222|NCT04796896|143266580|OTHER|The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years.|Vaccine Efficacy|0.432|||||TWO_SIDED|95.0|0.232|0.576|||||Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).|||0.576|0.232|
71874223|NCT01177787|143266583|OTHER||Mean Difference (Final Values)|-0.669|STANDARD_DEVIATION|0.03||0.503|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.503
71874224|NCT00402363|143266587|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.263|TWO_SIDED|95.0|0.9|1.46|||Regression, Cox|||||1.46|0.90|0.263
71874225|NCT00402363|143266588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.64||||0.089|TWO_SIDED|95.0|0.92|2.92|||Log Rank|||||2.92|0.92|0.089
71874226|NCT00402363|143266588|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.081|TWO_SIDED|95.0|0.98|1.52|||Regression, Cox|||||1.52|0.98|0.081
71874227|NCT00402363|143266589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.213|TWO_SIDED|95.0|0.91|1.49|||Regression, Cox|||||1.49|0.91|0.213
71874228|NCT00402363|143266589|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.5||||0.171|TWO_SIDED|95.0|0.83|2.69|||Log Rank|||||2.69|0.83|0.171
71874229|NCT00402363|143266590|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.082|TWO_SIDED|95.0|0.98|1.53|||Regression, Cox|||||1.53|0.98|0.082
71874230|NCT00402363|143266591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.331|TWO_SIDED|95.0|0.89|1.4|||Regression, Cox|||||1.40|0.89|0.331
71874231|NCT00402363|143266591|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.297|TWO_SIDED|95.0|0.79|2.11|||Log Rank|||||2.11|0.79|0.297
71874232|NCT00402363|143266592|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.168|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.168
71874233|NCT00402363|143266593|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.27|TWO_SIDED|95.0|0.9|1.43|||Regression, Cox|||||1.43|0.90|0.270
71874234|NCT00402363|143266593|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.19||||0.486|TWO_SIDED|95.0|0.73|1.95|||Log Rank|||||1.95|0.73|0.486
71874235|NCT00402363|143266594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.167|TWO_SIDED|95.0|0.94|1.42|||Regression, Cox|||||1.42|0.94|0.167
71874236|NCT00402363|143266595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.565|TWO_SIDED|95.0|0.81|1.47|||Regression, Cox|||||1.47|0.81|0.565
71874237|NCT00402363|143266595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.68||||0.103|TWO_SIDED|95.0|0.89|3.15|||Log Rank|||||3.15|0.89|0.103
71874238|NCT00402363|143266596|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.185|TWO_SIDED|95.0|0.92|1.56|||Regression, Cox|||||1.56|0.92|0.185
71874239|NCT00402363|143266597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.461|TWO_SIDED|95.0|0.83|1.51|||Regression, Cox|||||1.51|0.83|0.461
71874240|NCT00402363|143266597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.206|TWO_SIDED|95.0|0.79|2.86|||Log Rank|||||2.86|0.79|0.206
71874241|NCT00402363|143266598|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.2||||0.188|TWO_SIDED|95.0|0.92|1.57|||Regression, Cox|||||1.57|0.92|0.188
71874242|NCT00402363|143266599|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.07||||0.29|TWO_SIDED|95.0|-0.09|2.08|||non-parametric ANCOVA|||||2.08|-0.09|0.290
71874243|NCT00402363|143266599|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.063||||0.479|TWO_SIDED|95.0|-0.08|2.02|||Wilcoxon (Mann-Whitney)|||||2.02|-0.08|0.479
71874244|NCT00402363|143266599|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.039||||0.218|TWO_SIDED|95.0|-0.06|1.49|||non-parametric ANCOVA|||||1.49|-0.06|0.218
71874245|NCT00402363|143266600|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.321||||0.218|TWO_SIDED|95.0|-0.18|2.21|||non-parametric ANCOVA|||||2.21|-0.18|0.218
71874246|NCT00402363|143266600|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.216||||0.188|TWO_SIDED|95.0|-0.14|3.14|||Wilcoxon (Mann-Whitney)|||||3.14|-0.14|0.188
71874247|NCT00402363|143266600|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.181||||0.097|TWO_SIDED|95.0|-0.1|2.1|||non-parametric ANCOVA|||||2.10|-0.10|0.097
71874248|NCT00402363|143266601|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.242||||0.239|TWO_SIDED|95.0|-0.19|2.17|||non-parametric ANCOVA|||||2.17|-0.19|0.239
71874249|NCT00402363|143266601|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.249||||0.152|TWO_SIDED|95.0|-0.09|4.31|||Wilcoxon (Mann-Whitney)|||||4.31|-0.09|0.152
71874250|NCT00402363|143266601|SUPERIORITY_OR_OTHER||median difference (Hodges-Lehmann)|0.2||||0.094|TWO_SIDED|95.0|-0.08|2.11|||non-parametric ANCOVA|||||2.11|-0.08|0.094
71874251|NCT02634346|143266602|SUPERIORITY||Least square mean difference|-6.4|STANDARD_ERROR_OF_MEAN|1.83|<|0.001|TWO_SIDED|95.0|-10.0|-2.8|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-2.8|-10.0|<0.001
71874252|NCT02634346|143266602|SUPERIORITY||Least square mean difference|-5.3|STANDARD_ERROR_OF_MEAN|1.84||0.004|TWO_SIDED|95.0|-8.9|-1.7|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-1.7|-8.9|0.004
71874253|NCT02634346|143266603|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.118||0.002|TWO_SIDED|95.0|-0.61|-0.14|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.14|-0.61|0.002
71874254|NCT02634346|143266603|SUPERIORITY||Least square mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.118|<|0.001|TWO_SIDED|95.0|-0.67|-0.2|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.||||-0.20|-0.67|<0.001
71874255|NCT01676909|143266605|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.362
71874256|NCT01676909|143266606|SUPERIORITY|||||||0.026|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.026
71874257|NCT01676909|143266607|SUPERIORITY|||||||0.032|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.||||0.032
71874258|NCT01676909|143266608|SUPERIORITY|||||||0.64|||||||Mixed Models Analysis|||A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.||||.64
71874259|NCT01676909|143266609|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||<.0001
71874260|NCT01676909|143266610|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
71874261|NCT01676909|143266611|SUPERIORITY|||||||0.544|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.544
71874262|NCT01676909|143266612|SUPERIORITY|||||||0.699|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.699
71874263|NCT01676909|143266613|SUPERIORITY|||||||0.006|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.006
71874264|NCT01676909|143266614|SUPERIORITY|||||||0.762|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.762
71874265|NCT01676909|143266615|SUPERIORITY|||||||0.326|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.326
71874266|NCT01676909|143266616|SUPERIORITY|||||||0.667|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.667
71874267|NCT01676909|143266617|SUPERIORITY|||||||0.142|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.142
71874268|NCT01676909|143266618|SUPERIORITY|||||||0.342|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.342
71874269|NCT01676909|143266619|SUPERIORITY|||||||0.563|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.563
71874270|NCT01676909|143266620|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.004
71874271|NCT01676909|143266621|SUPERIORITY|||||||0.727|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.727
71874272|NCT01676909|143266622|SUPERIORITY|||||||0.446|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.446
71916119|NCT03728881|143353687|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.9|||||TWO_SIDED|99.0|0.75|1.08|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.08|0.75|
71683926|NCT00432276|142886245|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.934|TWO_SIDED|95.0|-2.9|2.6||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.||Comparison of change from Baseline at Week 52.||2.6|-2.9|0.934
71916120|NCT03728881|143353688|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71916121|NCT03728881|143353689|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.006|||||||Fisher Exact|||||||=0.006
71916122|NCT03728881|143353690|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71916123|NCT03728881|143353691|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.48|||||||Fisher Exact|||||||=0.48
71916124|NCT03728881|143353697|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.42|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.56|0.42|
71916125|NCT03728881|143353698|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.||||||1|||||||Fisher Exact|||||||1.0
71916126|NCT03728881|143353700|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.09|||||TWO_SIDED|96.0|0.93|1.27||||||||1.27|0.93|
71916127|NCT03728881|143353701|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.0006|||||||Fisher Exact|||||||=0.0006
71916128|NCT03728881|143353703|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.35|0.49|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.49|0.35|
71916129|NCT03728881|143353704|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71916130|NCT03728881|143353706|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.86|||||TWO_SIDED|99.0|0.71|1.04|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.04|0.71|
71916131|NCT03728881|143353707|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.478|||||||Fisher Exact|||||||=0.478
71916132|NCT03728881|143353709|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.58|1.12|
71916133|NCT03728881|143353712|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.29|||||TWO_SIDED|95.0|1.09|1.54|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.54|1.09|
71916134|NCT03728881|143353715|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.48|||||TWO_SIDED|95.0|1.2|1.81|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.81|1.20|
71916135|NCT03728881|143353716|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||||||=1.0
71916136|NCT03728881|143353718|NON_INFERIORITY|We reject the noninferiority hypothesis if the lower limit of the two-sided 95% confidence interval on R ≥ 0.67 for HPV16 and HPV18.|GMC Ratio|1.42|||||TWO_SIDED|95.0|1.15|1.75|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||1.75|1.15|
71916137|NCT03728881|143353719|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose 9-10 year old girls and one-dose 11-14 year old girls. A p-value under 0.05 will be regarded as significant.|||||=|0.368|||||||Fisher Exact|||||||=0.368
71916138|NCT03728881|143353721|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.46|||||TWO_SIDED|96.0|0.38|0.56|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.56|0.38|
71916139|NCT03728881|143353721|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.58|||||TWO_SIDED|96.0|0.48|0.7|||||Generalized estimating equations were used to estimate R and construct confidence intervals.|||0.70|0.48|
71916140|NCT03728881|143353721|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.079||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.079
71916141|NCT03728881|143353722|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|1|||||||Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 36 months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.0000
71916142|NCT03728881|143353724|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01|||||TWO_SIDED|96.0|0.82|1.25||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.25|0.82|
71916143|NCT03728881|143353724|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.24|||||TWO_SIDED|96.0|1.01|1.54||||||The cohort for the analysis of HPV16 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11.||1.54|1.01|
71916144|NCT03728881|143353724|EQUIVALENCE|A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|||||=|0.14||||||The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|p-values test for heterogeneity|||||||=0.14
71916145|NCT03728881|143353725|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the younger one-dose recipients and the younger three-dose recipients.|||||=|0.001||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between younger one-dose recipients (9-11 Year Old Girls) and the younger three-dose recipients (18-21 Year Old Women).||||=0.001
71916146|NCT03728881|143353725|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients. A p-value under 0.05 will be regarded as significant.|||||=|0.737||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between older one-dose recipients (12-14 Year Old Girls) and the older three-dose recipients (22-25 Year Old Women).||||=0.737
71916147|NCT03728881|143353727|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.41|||||TWO_SIDED|99.0|0.33|0.52||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.52|0.33|
71916148|NCT03728881|143353727|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.47|||||TWO_SIDED|99.0|0.37|0.6||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.60|0.37|
71683927|NCT00432276|142886246|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.07|TWO_SIDED|95.0|-1.3|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.||Comparison of change from Baseline at Week 52.||0.1|-1.3|0.070
71916149|NCT03728881|143353727|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.028||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.028
71916150|NCT03728881|143353728|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between the older one-dose recipients and the older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 24months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).||||=1.000
71916151|NCT03728881|143353730|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.85|||||TWO_SIDED|99.0|0.65|1.1||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.10|0.65|
71916152|NCT03728881|143353730|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.0|||||TWO_SIDED|99.0|0.77|1.29||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.29|0.77|
71916153|NCT03728881|143353730|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.24||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.24
71916154|NCT03728881|143353731|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between younger one-dose and younger three-dose recipients.|||||=|0.216||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between younger one-dose recipients (9-12 Year Old Girls) and younger three-dose recipients (18-21 Year Old Women).||||=0.216
71916155|NCT03728881|143353731|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between older one-dose and older three-dose recipients.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between older one-dose recipients (12-14 Year Old Girls) and older three-dose recipients (22-25 Year Old Women).||||=1.000
71916156|NCT03728881|143353733|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52|||||TWO_SIDED|96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
71916157|NCT03728881|143353733|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.49|||||TWO_SIDED|96.0|0.41|0.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.58|0.41|
71874273|NCT01676909|143266623|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.459
71874274|NCT01676909|143266624|SUPERIORITY|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.038
71874275|NCT01676909|143266625|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.238
71874276|NCT01676909|143266626|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.011
71874277|NCT01676909|143266627|SUPERIORITY|||||||0.709|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.709
71874278|NCT01676909|143266628|SUPERIORITY|||||||0.134|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.134
71874279|NCT01676909|143266629|SUPERIORITY|||||||0.045|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.045
71874280|NCT01676909|143266630|SUPERIORITY|||||||0.099|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.099
71874281|NCT01676909|143266631|SUPERIORITY|||||||0.852|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.852
71874282|NCT01676909|143266632|SUPERIORITY|||||||0.285|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.285
71874283|NCT01676909|143266633|SUPERIORITY|||||||0.222|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.||||0.222
71874284|NCT00823901|143266647|SUPERIORITY_OR_OTHER|||||||0.15|||||||t-test, 2 sided|||||||0.15
71874285|NCT01369511|143266653|SUPERIORITY_OR_OTHER|||||||0.527|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.527
71874286|NCT01369511|143266653|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.291
71874287|NCT01369511|143266653|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12||||0.129
71874288|NCT01369511|143266654|SUPERIORITY_OR_OTHER|||||||0.751|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.751
71874289|NCT01369511|143266654|SUPERIORITY_OR_OTHER|||||||0.066|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.066
71916158|NCT03728881|143353733|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.73||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.73
71683928|NCT00432276|142886247|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9||||0.064|TWO_SIDED|95.0|-5.9|0.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.||Comparison of change from Baseline at Week 52.||0.2|-5.9|0.064
71874290|NCT01369511|143266654|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8||||0.031
71874291|NCT01369511|143266654|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.315
71874292|NCT01369511|143266654|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.002
71874293|NCT01369511|143266654|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16||||0.007
71874294|NCT01376349|143266658|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71874295|NCT01376349|143266658|SUPERIORITY_OR_OTHER|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71874296|NCT01176968|143266664|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.581|||<|0.0001|TWO_SIDED|95.0|0.446|0.756||All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.|Regression, Cox|||Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.||0.756|0.446|< 0.0001
71874297|NCT01176968|143266665|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.562||||0.6406|TWO_SIDED|95.0|0.05|6.308|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||6.308|0.050|0.6406
71874298|NCT01176968|143266666|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.726||||0.5338|TWO_SIDED|95.0|0.265|1.99|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||1.990|0.265|0.5338
71874299|NCT01176968|143266668|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.083||||0.8042|TWO_SIDED|95.0|0.575|2.04|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||2.040|0.575|0.8042
71874300|NCT01176968|143266669|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.598||||0.0003|TWO_SIDED|95.0|0.452|0.791|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||0.791|0.452|0.0003
71874301|NCT01176968|143266670|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.069||||0.9353|TWO_SIDED|95.0|0.213|5.371|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||5.371|0.213|0.9353
71874302|NCT01176968|143266671|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.6||||0.3757|TWO_SIDED|95.0|0.566|4.525|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.||4.525|0.566|0.3757
71874303|NCT01176968|143266672|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.45||||0.1744|TWO_SIDED|95.0|-3.55|0.65|||ANCOVA|||ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.||0.65|-3.55|0.1744
71874304|NCT01176968|143266673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.7123|TWO_SIDED|95.0|-0.1|0.14||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.14|-0.10|0.7123
71874305|NCT01176968|143266673|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04||||0.4105|TWO_SIDED|95.0|-0.05|0.13||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.||0.13|-0.05|0.4105
71874306|NCT01176968|143266674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874307|NCT01176968|143266674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.5552|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.5552
71874308|NCT01176968|143266674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||< 0.0001
71874309|NCT01176968|143266674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874310|NCT01176968|143266674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874311|NCT01176968|143266674|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3347|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.3347
71874312|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0005
71874313|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874314|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1558|TWO_SIDED||||||Wilcoxon-Rank Sum test|||For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.1558
71874315|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0008
71874316|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874317|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0293|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0293
71874318|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1723|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.1723
71874319|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0295|TWO_SIDED||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0295
71874320|NCT01176968|143266675|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0865|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0865
71874321|NCT01176968|143266676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0944|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0944
71874322|NCT01176968|143266676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|TWO_SIDED||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||0.0360
71874323|NCT01176968|143266676|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6459|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.6459
71874324|NCT01176968|143266677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874325|NCT01176968|143266677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.||||< 0.0001
71874326|NCT01176968|143266677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0801|TWO_SIDED||||||Wilcoxon Rank-Sum test|||For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.||||0.0801
71874327|NCT05193500|143266701|OTHER|||||||0.085||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|one-sample t-test, compared to 0.5 (chance)||||||0.085
71874328|NCT05193500|143266701|OTHER|||||||0.049||||||a priori threshold for statistical significance is 0.05|t-test, 2 sided|||||||0.049
71874329|NCT05193500|143266702|OTHER|||||||0.015||||||a priori threshold for statistical significance = 0.05|t-test, 2 sided|||||||0.015
71874330|NCT00784693|143266732|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-0.87|1.69||||||Week 8: Analysis was based on analysis of co-variance (ANCOVA) model with main effects of treatment, contraceptive use and baseline severity of pain.||1.69|-0.87|
71874331|NCT01324323|143266752|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean (%)|179.3|||||TWO_SIDED|90.0|160.3|200.7|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||200.7|160.3|
71874332|NCT01324323|143266753|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|178.3|||||TWO_SIDED|90.0|159.4|199.4|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||199.4|159.4|
71874333|NCT01324323|143266754|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|179.6|||||TWO_SIDED|90.0|160.5|201.0|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||201.0|160.5|
71874334|NCT01324323|143266755|SUPERIORITY_OR_OTHER_LEGACY||Ratio of the Geometric Mean|159.1|||||TWO_SIDED|90.0|135.8|186.5|||ANOVA||"Ratio (Romidepsin + rifampin/Romidepsin) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values."|||186.5|135.8|
71874335|NCT01324323|143266756|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.15||||0.791|TWO_SIDED|90.0|-1.0|1.01|||Wilcoxon signed-rank|||"Note: The median, median difference (romidepsin + rifampin minus romidepsin) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test."||1.01|-1.0|0.7910
71874336|NCT01821378|143266761|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-3.1||||0.255|TWO_SIDED|95.0|-8.4|2.2|||Mixed Models Analysis|||||2.2|-8.4|0.255
71874337|NCT01821378|143266761|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-10.3|||<|-0.001|TWO_SIDED|95.0|-14.9|-5.7|||Mixed Models Analysis|||||-5.7|-14.9|<-0.001
71874338|NCT01821378|143266762|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.2||||0.169|TWO_SIDED|95.0|-0.49|0.09|||Mixed Models Analysis|||||0.09|-0.49|0.169
71683929|NCT00432276|142886248|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-1.0|-0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.||Comparison of change from Baseline at Week 52.||-0.1|-1.0|0.022
71874339|NCT01821378|143266762|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.57|||<|0.001|TWO_SIDED|95.0|-0.83|-0.32|||Mixed Models Analysis|||||-0.32|-0.83|<0.001
71874340|NCT01821378|143266763|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.3||||0.706|TWO_SIDED|95.0|-1.8|1.2|||ANCOVA|||||1.2|-1.8|0.706
71874341|NCT01821378|143266763|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-2.0||||0.003|TWO_SIDED|95.0|-3.3|-0.7|||ANCOVA|||||-0.7|-3.3|0.003
71874342|NCT01821378|143266764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.173|TWO_SIDED|95.0|0.8|2.5|||Regression, Logistic|||||2.5|0.8|0.173
71874343|NCT01821378|143266764|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|2.0|5.2|||Regression, Logistic|||||5.2|2.0|<0.001
71874344|NCT01821378|143266765|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.7||||0.023|TWO_SIDED|95.0|-14.3|-1.1|||Mixed Models Analysis|||||-1.1|-14.3|0.023
71874345|NCT01821378|143266766|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.8||||0.464|TWO_SIDED|95.0|-2.9|1.3|||ANCOVA|||||1.3|-2.9|0.464
71874346|NCT01821378|143266766|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.8||||0.122|TWO_SIDED|95.0|-4.1|0.5|||ANCOVA|||||0.5|-4.1|0.122
71874347|NCT01821378|143266767|SUPERIORITY_OR_OTHER||Least Square Mean Difference|2.3||||0.258|TWO_SIDED|95.0|-1.7|6.2|||Mixed Models Analysis|||||6.2|-1.7|0.258
71874348|NCT01821378|143266767|SUPERIORITY_OR_OTHER||Slope|6.6|||<|0.001|TWO_SIDED|95.0|3.2|10.1|||Mixed Models Analysis|||||10.1|3.2|<0.001
71874349|NCT01821378|143266768|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.35||||0.052|TWO_SIDED|95.0|-0.7|0.0|||Mixed Models Analysis|||||0.00|-0.70|0.052
71874350|NCT01821378|143266769|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.084||||0.012|TWO_SIDED|95.0|0.018|0.149|||ANCOVA|||||0.149|0.018|0.012
71874351|NCT01821378|143266769|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.138|||<|0.001|TWO_SIDED|95.0|0.081|0.194|||ANCOVA|||||0.194|0.081|<0.001
71874352|NCT01821378|143266770|SUPERIORITY_OR_OTHER||Least Square Mean Difference|0.0||||0.992|TWO_SIDED|95.0|-6.6|6.6|||Mixed Models Analysis|||||6.6|-6.6|0.992
71874353|NCT01821378|143266770|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-7.3||||0.044|TWO_SIDED|95.0|-14.4|-0.2|||Mixed Models Analysis|||||-0.2|-14.4|0.044
71874354|NCT01821378|143266771|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.1||||0.578|TWO_SIDED|95.0|-0.45|0.25|||Mixed Models Analysis|||||0.25|-0.45|0.578
71874355|NCT01821378|143266771|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.58||||0.003|TWO_SIDED|95.0|-0.96|-0.2|||Mixed Models Analysis|||||-0.20|-0.96|0.003
71874356|NCT02888665|143266773|OTHER||see above|||||||||||see above. target ORR was not met.|||see above. target ORR was not met.|The primary objective of the phase II design compared ORR with historical rates (Judson et al. Lancet Onc., 2014). A 2-stage design with null hypothesis of 15% using a 1-sided 0.05 α level test has 85% power to detect an increase to 35%. This required up to 35 patients. After 2 responses in stage 1 (20 pts), the study moved to stage 2 (15 pts). If 10 responses were seen (29%), this would have ruled out an ORR of 15%. The study was closed when it became clear we would not meet this benchmark.|see above. target ORR was not met.|||
71874357|NCT02119325|143266784|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-4.64||||0.0487|TWO_SIDED|95.0|-9.26|-0.03||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect."||-0.03|-9.26|0.0487
71874358|NCT02119325|143266785|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|-6.79||||0.6116|TWO_SIDED|95.0|-34.02|20.44||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect."||20.44|-34.02|0.6116
71874359|NCT00986440|143266872|SUPERIORITY||Z statistic for difference|3.92|||<|0.0001|TWO_SIDED||||||2-sided P value for z test|||||||<0.0001
71874360|NCT00986440|143266872|SUPERIORITY||Hazard Ratio, log|-0.41|||||TWO_SIDED|||||||||||||
71874361|NCT00986440|143266873|SUPERIORITY|||||||0.038|||||||Log Rank|||||||0.0380
71874362|NCT00986440|143266873|SUPERIORITY|||||||0.1773|||||||Peto-Peto-Prentice|||||||0.1773
71874363|NCT00986440|143266873|SUPERIORITY|||||||0.2844|||||||Wilcoxon (Mann-Whitney)|||||||0.2844
71874364|NCT00986440|143266873|SUPERIORITY|||||||0.114|||||||Tarone-Ware|||||||0.1140
71874365|NCT00986440|143266874|SUPERIORITY|||||||0.1213|||||||Log Rank|||||||0.1213
71874366|NCT04526197|143266878|OTHER|Confidence Interval|Ratio of geometric LS means|0.881|||||TWO_SIDED|90.0|0.776|1.001||||||||1.001|0.776|
71874367|NCT04526197|143266879|OTHER|Confidence Interval|Ratio of geometric LS means|1.016|||||TWO_SIDED|90.0|0.959|1.077||||||||1.077|0.959|
71874368|NCT04526197|143266880|OTHER|Confidence Interval|Ratio of geometric LS means|1.01|||||TWO_SIDED|90.0|0.954|1.07||||||||1.070|0.954|
71874369|NCT02411578|143266888|SUPERIORITY|||||||0.99||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.||||0.99
71874370|NCT02411578|143266889|SUPERIORITY|||||||0.34|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.34
71874371|NCT02411578|143266890|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.01
71874372|NCT02411578|143266891|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.02
71874373|NCT02411578|143266892|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.86
71874374|NCT02411578|143266893|SUPERIORITY|||||||0.95|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.95
71874375|NCT02411578|143266894|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.78
71874376|NCT02411578|143266895|SUPERIORITY|||||||0.21|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.21
71874377|NCT02411578|143266896|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.09
71874378|NCT02411578|143266897|SUPERIORITY|||||||0.49|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.49
71874379|NCT02411578|143266898|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.63
71874380|NCT02411578|143266899|SUPERIORITY|||||||0.41|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.41
71874381|NCT02411578|143266900|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.80
71874382|NCT02411578|143266901|SUPERIORITY|||||||0.13|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.13
71874383|NCT02411578|143266902|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.||||||0.70
71874384|NCT02411578|143266903|SUPERIORITY|||||||0.93||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.93
71874385|NCT02411578|143266904|SUPERIORITY|||||||0.66||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.66
71874386|NCT02411578|143266905|SUPERIORITY|||||||0.08||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||||||0.08
71874387|NCT02460666|143266906|SUPERIORITY|||||||0.3|||||||Mixed Models Analysis|||||||0.3
71874388|NCT02460666|143266907|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
71874389|NCT02460666|143266908|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
71874390|NCT02460666|143266909|SUPERIORITY|||||||0.09|||||||Mixed Models Analysis|||||||0.09
71916159|NCT03728881|143353734|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate one-dose and three-dose recipients who enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
71874391|NCT01323621|143266911|SUPERIORITY_OR_OTHER||Least squares mean difference|0.029||||0.267||95.0|-0.022|0.08|||ANCOVA||ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.|||0.080|-0.022|0.267
71874392|NCT01557348|143266917|SUPERIORITY_OR_OTHER|||||||0.0068||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0068
71874393|NCT01557348|143266918|SUPERIORITY_OR_OTHER|||||||0.0588||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||||||0.0588
71874394|NCT01557348|143266919|SUPERIORITY_OR_OTHER|||||||0.1126||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 6||||0.1126
71874395|NCT01557348|143266919|SUPERIORITY_OR_OTHER|||||||0.2342||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 12||||0.2342
71874396|NCT01557348|143266920|SUPERIORITY_OR_OTHER|||||||0.4168||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 6||||0.4168
71874397|NCT01557348|143266920|SUPERIORITY_OR_OTHER|||||||0.5867||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 12||||0.5867
71874398|NCT01557348|143266921|SUPERIORITY_OR_OTHER|||||||0.8758||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 6||||0.8758
71874399|NCT01557348|143266921|SUPERIORITY_OR_OTHER|||||||0.4849||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 12||||0.4849
71874400|NCT01557348|143266922|SUPERIORITY_OR_OTHER|||||||0.0086||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 6||||0.0086
71874401|NCT01557348|143266922|SUPERIORITY_OR_OTHER|||||||0.2918||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 12||||0.2918
71874402|NCT01557348|143266923|SUPERIORITY_OR_OTHER|||||||0.0764||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 6||||0.0764
71874403|NCT01557348|143266923|SUPERIORITY_OR_OTHER|||||||0.0587||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 12||||0.0587
71874404|NCT01557348|143266924|SUPERIORITY_OR_OTHER|||||||0.0443||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 6||||0.0443
71874405|NCT01557348|143266924|SUPERIORITY_OR_OTHER|||||||0.4802||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 12||||0.4802
71874406|NCT01557348|143266925|SUPERIORITY_OR_OTHER|||||||0.2026||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 6||||0.2026
71874407|NCT01557348|143266925|SUPERIORITY_OR_OTHER|||||||0.0295||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 12||||0.0295
71874408|NCT01557348|143266926|SUPERIORITY_OR_OTHER|||||||0.337||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 6||||0.3370
71874409|NCT01557348|143266926|SUPERIORITY_OR_OTHER|||||||0.1515||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 12||||0.1515
71874410|NCT01557348|143266927|SUPERIORITY_OR_OTHER|||||||0.3253||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 6||||0.3253
71874411|NCT01557348|143266927|SUPERIORITY_OR_OTHER|||||||0.3535||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 12||||0.3535
71874412|NCT04484259|143266958|NON_INFERIORITY|non-inferiority margin 45 PRU|Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-23.0|38.0||||||The primary end point was non-inferiority of Ticagrelor 60 mg monotherapy vs. aspirin plus Ticagrelor 60 mg||38|-23|
71874413|NCT03645954|143266979|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||<0.01
71874414|NCT03645954|143266980|SUPERIORITY||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
71874415|NCT03645954|143266981|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
71874416|NCT03645954|143266982|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
71874417|NCT03645954|143266983|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|||||||>0.05
71874418|NCT03645954|143266984|OTHER||||||>|0.05||||||The threshold for statistical significance was p = 0.05.|Chi-squared|||||||>0.05
71874419|NCT02072434|143267076|OTHER||Odds Ratio (OR)|0.46|||||TWO_SIDED|95.0|0.12|1.43||||||||1.43|0.12|
71874420|NCT02072434|143267077|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.64|3.55||||||||3.55|0.64|
71683930|NCT00432276|142886249|SUPERIORITY_OR_OTHER||LS Mean Difference|1.78||||0.308|TWO_SIDED|95.0|-1.65|5.22||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.||Comparison of change from Baseline at Week 52.||5.22|-1.65|0.308
71683931|NCT00432276|142886250|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8209||||0.283|TWO_SIDED|95.0|-2.3209|0.679||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.||Comparison of change from Baseline at Week 52.||0.6790|-2.3209|0.283
71683932|NCT00432276|142886251|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.92|||<|0.001|TWO_SIDED|95.0|-4.57|-1.27||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.||Comparison of change from Baseline at Week 52.||-1.27|-4.57|<0.001
71683933|NCT00432276|142886252|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.1||||0.197|TWO_SIDED|95.0|-15.4|3.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|||Comparison of change from Baseline at Week 52.||3.2|-15.4|0.197
71683934|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental,control) × 2(Activity: singing,verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, believability of thought were equivalent across time||||<0.001
71683935|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in believability of thought from baseline to post-intervention. Null hypothesis: there would be no significant difference in believability of thought from baseline to post-intervention||||<0.001
71683936|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences from post-intervention to follow-up. Null hypothesis: there would be no significant differences in believability of thought from post-intervention to follow-up.||||<0.001
71683937|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal believability scores||||>0.05
71874421|NCT02072434|143267078|OTHER||Difference between percentages|-0.72|||||TWO_SIDED|95.0|-1.59|0.15||||||||0.15|-1.59|
71874422|NCT01117454|143267079|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank with continuity correction||||||0.008
71874423|NCT04356183|143267088|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71874424|NCT04356183|143267089|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71874425|NCT04356183|143267090|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71874426|NCT01570036|143267097|OTHER|Kaplan-Meier Survival Analysis|Hazard Ratio (HR)|0.62||||0.18|TWO_SIDED|95.0|0.31|1.25|||Kaplan-Meier Survival Analysis|||||1.25|.31|0.18
71874427|NCT01570036|143267099|OTHER|||||||0.02||||||Comparison of the mean LVEF from baseline to 3 months, 6 months, and 12 months; this time period includes the therapy period of trastuzumab.|ANOVA|||||||0.02
71874428|NCT01570036|143267099|OTHER|||||||0.58||||||The mean LVEF compared at baseline to 3 months, 6 months, 12 months and 24 months; this time period includes the duration of trastuzumab therapy and 1 year after completion of trastuzumab therapy.|ANOVA|||||||0.58
71874429|NCT01570036|143267099|OTHER|||||||0.65||||||Evaluating LVEF at all time points with a linear mixed regression model, this analysis compared cardiac ejection fraction over time.|Regression, Linear|||||||0.65
71874430|NCT01570036|143267099|OTHER|||||||0.91||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between randomization arms.|Regression, Linear|||||||0.91
71874431|NCT01570036|143267099|OTHER|||||||0.81||||||This analysis evaluated LVEF at all time points with a linear mixed regression model between the arms over time.|Regression, Linear|||||||0.81
71874432|NCT01570036|143267100|OTHER|||||||0.149|||||||Chi-squared|Comparison of the maximum related local toxicity experienced per patient and compared between treatment arms.||The safety group consisted of any patients who received NPS with GM-CSF or placebo with GM-CSF inoculations.||||0.149
71874433|NCT01570036|143267100|OTHER|||||||0.901|||||||Chi-squared|Comparison of the maximum related systemic toxicity experienced per patient and compared between treatment arms.||||||0.901
71874434|NCT01346488|143267105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71683938|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal believability scores||||>0.05
71683939|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in believability scores||||>0.05
71874435|NCT01346488|143267105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874436|NCT01346488|143267105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874437|NCT01346488|143267105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874438|NCT01346488|143267105|SUPERIORITY_OR_OTHER|||||||1||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||1.0000
71874439|NCT01346488|143267105|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874440|NCT01346488|143267106|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874441|NCT01346488|143267106|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874442|NCT01346488|143267106|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874443|NCT01346488|143267106|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874444|NCT01346488|143267106|SUPERIORITY_OR_OTHER|||||||0.0054||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0054
71874445|NCT01346488|143267106|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874446|NCT01346488|143267107|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||<0.0001
71874447|NCT01346488|143267107|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
71874448|NCT01346488|143267107|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874449|NCT01346488|143267107|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
71874450|NCT01346488|143267107|SUPERIORITY_OR_OTHER|||||||0.0592||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||0.0592
71874451|NCT01346488|143267107|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874452|NCT01346488|143267108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874453|NCT01346488|143267108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||<0.0001
71874454|NCT01346488|143267108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||<0.0001
71874455|NCT01346488|143267108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||<0.0001
71874456|NCT01346488|143267108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
71874457|NCT01346488|143267108|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874458|NCT01346488|143267109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874459|NCT01346488|143267109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874460|NCT01346488|143267109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874461|NCT01346488|143267109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874462|NCT01346488|143267109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
71874463|NCT01346488|143267109|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874464|NCT01346488|143267110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||<0.0001
71874465|NCT01346488|143267110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
71874466|NCT01346488|143267110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
71874467|NCT01346488|143267110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
71874468|NCT01346488|143267110|SUPERIORITY_OR_OTHER||||||=|0.0005||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||= 0.0005
71874469|NCT01346488|143267110|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
71874470|NCT01346488|143267111|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874471|NCT01346488|143267111|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874472|NCT01346488|143267111|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874473|NCT01346488|143267111|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874474|NCT01346488|143267111|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
71874475|NCT01346488|143267111|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874476|NCT01346488|143267112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
71874477|NCT01346488|143267112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
71874478|NCT01346488|143267112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
71874479|NCT01346488|143267112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
71874480|NCT01346488|143267112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
71874481|NCT01346488|143267112|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
71874482|NCT01346488|143267113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874483|NCT01346488|143267113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874484|NCT01346488|143267113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874485|NCT01346488|143267113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874486|NCT01346488|143267113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
71874487|NCT01346488|143267113|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874488|NCT01346488|143267114|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
71874489|NCT01346488|143267114|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
71874490|NCT01346488|143267114|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
71874491|NCT01346488|143267114|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
71874492|NCT01346488|143267114|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
71874493|NCT01346488|143267114|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
71874494|NCT01346488|143267115|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874495|NCT01346488|143267115|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874496|NCT01346488|143267115|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874497|NCT01346488|143267115|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874498|NCT01346488|143267115|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
71874499|NCT01346488|143267115|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874500|NCT01346488|143267116|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)||||< 0.0001
71874501|NCT01346488|143267116|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)||||< 0.0001
71874502|NCT01346488|143267116|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)||||< 0.0001
71874503|NCT01346488|143267116|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)||||< 0.0001
71874504|NCT01346488|143267116|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)||||< 0.0001
71874505|NCT01346488|143267116|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)||||< 0.0001
71874506|NCT01346488|143267117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12||||< 0.0001
71874507|NCT01346488|143267117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24||||< 0.0001
71874508|NCT01346488|143267117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36||||< 0.0001
71874509|NCT01346488|143267117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48||||< 0.0001
71874510|NCT01346488|143267117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy||||< 0.0001
71874511|NCT01346488|143267117|SUPERIORITY_OR_OTHER||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment||||< 0.0001
71874512|NCT01008696|143267120|SUPERIORITY_OR_OTHER|||||||0.8849||||||Homozygous extensive metabolizer|Chi-squared|||||||0.8849
71874513|NCT01008696|143267120|SUPERIORITY_OR_OTHER|||||||0.865||||||Heterozygous extensive metabolizer|Chi-squared|||||||0.8650
71683940|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent believability scores across time.||||>0.05
71874514|NCT01008696|143267120|SUPERIORITY_OR_OTHER|||||||0.266||||||Poor metabolizer|Chi-squared|||||||0.2660
71874515|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.7734||||||Change at Day 57: Heartburn|Wilcoxon rank-sum test|||||||0.7734
71874516|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.6414||||||Change at Day 57: Regurgitation|Wilcoxon rank-sum test|||||||0.6414
71874517|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.7809||||||Change at Day 57: Globus sensation|Wilcoxon rank-sum test|||||||0.7809
71874518|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.8294||||||Change at Day 57: Chronic cough|Wilcoxon rank-sum test|||||||0.8294
71874519|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.9874||||||Change at Day 57: Epigastric pain|Wilcoxon rank-sum test|||||||0.9874
71874520|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.2776||||||Change at Day 57: Non cardiac chest pain|Wilcoxon rank-sum test|||||||0.2776
71874521|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.6295||||||Change at Day 57: Hoarseness|Wilcoxon rank-sum test|||||||0.6295
71874522|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.5335||||||Change at Day 57: Dysphagia|Wilcoxon rank-sum test|||||||0.5335
71874523|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.8068||||||Change at Day 57: Abdominal distension|Wilcoxon rank-sum test|||||||0.8068
71874524|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.568||||||Change at Day 57: Bloating|Wilcoxon rank-sum test|||||||0.5680
71874525|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.5913||||||Change at Day 57: Post-prandial discomfort|Wilcoxon rank-sum test|||||||0.5913
71874526|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.5566||||||Change at Day 57: Early satiety|Wilcoxon rank-sum test|||||||0.5566
71874527|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.7047||||||Change at Day 57: Nausea|Wilcoxon rank-sum test|||||||0.7047
71874528|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.3654||||||Change at Day 57: Vomitting|Wilcoxon rank-sum test|||||||0.3654
71874529|NCT01008696|143267121|SUPERIORITY_OR_OTHER|||||||0.531||||||Change at Day 57: Belching|Wilcoxon rank-sum test|||||||0.5310
71874530|NCT01008696|143267122|SUPERIORITY_OR_OTHER|||||||0.5032|||||||Wilcoxon rank-sum test|||||||0.5032
71874531|NCT02175004|143267155|SUPERIORITY||Least Squares Mean Difference|-17.84|||<|0.001|TWO_SIDED|95.0|-26.12|-9.56||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 78||-9.56|-26.12|<0.001
71874532|NCT02175004|143267155|SUPERIORITY||Least Squares Mean Difference|-20.11|||<|0.001|TWO_SIDED|95.0|-31.27|-8.95||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS+7 Composite Score at Week 156||-8.95|-31.27|<0.001
71874533|NCT02175004|143267156|SUPERIORITY||Least Squares Mean Difference|-0.06||||0.638|TWO_SIDED|95.0|-0.32|0.2||P-value=MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 78||0.20|-0.32|0.638
71874534|NCT02175004|143267156|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.965|TWO_SIDED|95.0|-0.3|0.29||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Week 156||0.29|-0.30|0.965
71874535|NCT02175004|143267157|SUPERIORITY||Least Squares Mean Difference|-1.09|||<|0.001|TWO_SIDED|95.0|-1.68|-0.5||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 78||-0.50|-1.68|<0.001
71874536|NCT02175004|143267157|SUPERIORITY||Least Squares Mean Difference|-0.66||||0.067|TWO_SIDED|95.0|-1.38|0.05||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Week 156||0.05|-1.38|0.067
71874537|NCT02175004|143267158|SUPERIORITY||Least Squares Mean Difference|0.34||||0.821|TWO_SIDED|95.0|-2.67|3.36||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 78||3.36|-2.67|0.821
71874538|NCT02175004|143267158|SUPERIORITY||Least Squares Mean Difference|-2.16||||0.293|TWO_SIDED|95.0|-6.21|1.9||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Week 156||1.90|-6.21|0.293
71874539|NCT02175004|143267159|SUPERIORITY||Least Squares Mean Difference|-2.78||||0.047|TWO_SIDED|95.0|-5.53|-0.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 78||-0.03|-5.53|0.047
71874540|NCT02175004|143267159|SUPERIORITY||Least Squares Mean Difference|-3.07||||0.041|TWO_SIDED|95.0|-6.0|-0.13||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Week 156||-0.13|-6.00|0.041
71874541|NCT02175004|143267160|OTHER||Least Squares Mean Difference|-17.48|||<|0.001|TWO_SIDED|95.0|-26.92|-8.03||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the NIS Composite Score at Week 52 of Year 4||-8.03|-26.92|<0.001
71874542|NCT02175004|143267161|SUPERIORITY||Least Squares Mean Difference|-0.01||||0.941|TWO_SIDED|95.0|-0.19|0.17||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Cranial Nerves Score Score at Week 52 of Year 4||0.17|-0.19|0.941
71874543|NCT02175004|143267162|SUPERIORITY||Least Squares Mean Difference|-9.56||||0.011|TWO_SIDED|95.0|-16.97|-2.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Muscle Weakness Score at Week 52 of Years 4||-2.16|-16.97|0.011
71874544|NCT02175004|143267163|SUPERIORITY||Least Squares Mean Difference|-1.05||||0.356|TWO_SIDED|95.0|-3.28|1.18||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Reflexes Score at Week 52 of Years 4||1.18|-3.28|0.356
71874545|NCT02175004|143267164|SUPERIORITY||Least Squares Mean Difference|-5.38|||<|0.001|TWO_SIDED|95.0|-8.58|-2.19||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the NIS Component: Sensory Score at Week 52 of Years 4||-2.19|-8.58|<0.001
71874546|NCT02175004|143267165|SUPERIORITY||Least Squares Mean Difference|-9.31||||0.026|TWO_SIDED|95.0|-17.48|-1.14||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||-1.14|-17.48|0.026
71874547|NCT02175004|143267165|SUPERIORITY||Least Squares Mean Difference|-7.4||||0.107|TWO_SIDED|95.0|-16.41|1.62||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 156||1.62|-16.41|0.107
71874548|NCT02175004|143267165|SUPERIORITY||Least Squares Mean Difference|-2.72||||0.669|TWO_SIDED|95.0|-15.22|9.77||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 52 of Year 4||9.77|-15.22|0.669
71874549|NCT02175004|143267166|SUPERIORITY||Least Squares Mean Difference|-6.3||||0.097|TWO_SIDED|95.0|-13.75|1.15||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Change From CS2 Baseline in the Norfolk QOL-DN Questionnaire Total Score at Week 78||1.15|-13.75|0.097
71874550|NCT02175004|143267166|SUPERIORITY||Least Squares Mean Difference|-8.89||||0.081|TWO_SIDED|95.0|-18.88|1.11||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change from Baseline in the Norfolk QoL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 156||1.11|-18.88|0.081
71874551|NCT02175004|143267166|SUPERIORITY||Least Squares Mean Difference|-11.87||||0.171|TWO_SIDED|95.0|-28.89|5.16||P-value= MMRM with fixed categorical effects for treatment, time, treatment-by-time interaction, each of 3 randomization stratification factors, fixed covariates for parent study baseline value, baseline-by-time interaction.|MMRM|||Change From Baseline in the Norfolk QOL-DN Physical Functioning/Large Fiber Neuropathy Domain Score at Week 52 of Year 4||5.16|-28.89|0.171
71874552|NCT01383161|143267188|SUPERIORITY|||||||0.5|||||||mixed-effects general linear model|||||||0.5
71874553|NCT01383161|143267188|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71874554|NCT01383161|143267188|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71874555|NCT01383161|143267189|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
71874556|NCT01383161|143267189|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||.006
71874557|NCT01383161|143267189|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71874558|NCT01383161|143267190|SUPERIORITY|||||||0.05|||||||mixed-effects general linear model|||||||0.05
71874559|NCT01383161|143267190|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71874560|NCT01383161|143267190|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.8
71874561|NCT01383161|143267191|SUPERIORITY|||||||0.08|||||||mixed-effects general linear model|||||||0.08
71874562|NCT01383161|143267191|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||.002
71874563|NCT01383161|143267191|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.5
71874564|NCT01383161|143267192|SUPERIORITY|||||||0.04|||||||mixed-effects general linear model|||||||0.04
71874565|NCT01383161|143267192|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71874566|NCT01383161|143267192|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.1
71874567|NCT01383161|143267193|SUPERIORITY|||||||0.3|||||||mixed-effects general linear model|||||||0.3
71874568|NCT01383161|143267193|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71874569|NCT01383161|143267193|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||||||0.6
71874570|NCT00819286|143267214|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||3 Month CT Scores (Plates vs Wires)||||0.003
71874571|NCT00819286|143267214|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||6 Month CT Scores (Plates vs Wires)||||0.01
71874572|NCT00819286|143267215|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.93||95.0|||||t-test, 1 sided|||Plates vs Wires||||0.93
71874573|NCT03153137|143267235|SUPERIORITY|For each stage, the p-value from the ANCOVA model including randomized treatment, geographical region, and baseline peak VO2 was used to construct the final adjusted p-value.|Median unbiased estimate and repeated CI|0.62|||=|0.193|TWO_SIDED|99.0|-0.62|1.85||Final adjusted p-value (from weighted inverse normal combination test)|ANCOVA|||Due to adaptive nature of the design, the main analysis was conducted on FAS using the inverse normal combination method with pre-specified weights to combine first and second stage p-values.||1.85|-0.62|= 0.1930
71874574|NCT01372410|143267272|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Day 8 analysis.|Wald Test|||||||<0.0001
71874575|NCT01372410|143267272|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Pooled Day 7 and 8 analysis.|Wald Test|||||||<0.0001
71874576|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|||<|0.001|TWO_SIDED|95.0|0.058|0.168|||Mixed Models Analysis|||||0.168|0.058|<0.001
71874577|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.158|||Mixed Models Analysis|||||0.158|0.045|<0.001
71874578|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.068|0.179|||Mixed Models Analysis|||||0.179|0.068|<0.001
71874579|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|||<|0.001|TWO_SIDED|95.0|0.127|0.239|||Mixed Models Analysis|||||0.239|0.127|<0.001
71874580|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.069|0.182|||Mixed Models Analysis|||||0.182|0.069|<0.001
71874581|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.139|||<|0.001|TWO_SIDED|95.0|0.083|0.196|||Mixed Models Analysis|||||0.196|0.083|<0.001
71874582|NCT01372410|143267273|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|||<|0.001|TWO_SIDED|95.0|0.045|0.157|||Mixed Models Analysis|||||0.157|0.045|<0.001
71874583|NCT01067326|143267308|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||Change in EPCs from baseline to 4 months||||0.02
71874584|NCT01067326|143267309|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||t-test, 2 sided|||Difference in systolic blood pressure from baseline to 4 months.||||.006
71874585|NCT01067326|143267310|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||t-test, 2 sided|||Difference in diastolic blood pressure from baseline to 4 months.||||0.04
71874586|NCT01067326|143267311|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||t-test, 2 sided|||P-value for intergroup comparison of change from baseline to month 4||||0.94
71874587|NCT00696761|143267312|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71874588|NCT00696761|143267313|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Kruskal-Wallis|||The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.||||<0.05
71874589|NCT01603082|143267340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-159.1|STANDARD_ERROR_OF_MEAN|17.9|<|0.001|TWO_SIDED|95.0|-194.7|-123.5|||t-test, 2 sided||Ticagrelor minus clopidogrel.|||-123.5|-194.7|<0.001
71874590|NCT01603082|143267341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|15.2||0.182|TWO_SIDED|95.0|-50.5|9.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 0.5 hours after the loading dose||9.7|-50.5|0.182
71874591|NCT01603082|143267341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-158.5|STANDARD_ERROR_OF_MEAN|15.5|<|0.001|TWO_SIDED|95.0|-189.4|-127.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 8 hours after the loading dose.||-127.7|-189.4|<0.001
71874592|NCT01603082|143267341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-43.6|STANDARD_ERROR_OF_MEAN|16.5||0.01|TWO_SIDED|95.0|-76.5|-10.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at end of PCI.||-10.7|-76.5|0.010
71874593|NCT00852592|143267342|SUPERIORITY_OR_OTHER||||||=|0.005|||||||ANOVA|||||||=0.005
71874594|NCT00852592|143267343|SUPERIORITY_OR_OTHER||||||=|0.004|||||||ANOVA|||||||=0.004
71874595|NCT00372385|143267347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.758||||0.0026|TWO_SIDED|95.0|1.424|5.34|||Regression, Logistic|||||5.340|1.424|0.0026
71874596|NCT00372385|143267347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.709||||0.959|TWO_SIDED|95.0|0.91|3.212|||Regression, Logistic|||||3.212|0.910|0.959
71874597|NCT00372385|143267347|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.589||||0.1089|TWO_SIDED|95.0|0.309|1.125|||Regression, Logistic|||||1.125|0.309|0.1089
71874598|NCT00372385|143267348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.632||||0.0041|TWO_SIDED|95.0|1.359|5.097|||Regression, Logistic|||||5.097|1.359|0.0041
71874599|NCT00372385|143267348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.623||||0.1324|TWO_SIDED|95.0|0.864|3.05|||Regression, Logistic|||||3.050|0.864|0.1324
71874600|NCT00372385|143267348|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.591||||0.1099|TWO_SIDED|95.0|0.311|1.126|||Regression, Logistic|||||1.126|0.311|0.1099
71874601|NCT01699789|143267353|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.57|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.57|
71874602|NCT01699789|143267354|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.48|1.26||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.26|0.48|
71874603|NCT01699789|143267355|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.77|||||TWO_SIDED|95.0|0.61|0.97||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.|In an analysis of change from baseline in likelihood of Poor Mental Health Quality of Life, CEP showed a significant advantage at 6 months, but not at 12 months.|0.97|0.61|
71758551|NCT02205736|143019222|SUPERIORITY|||||||0.0606||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 18 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0606
71874604|NCT01699789|143267356|SUPERIORITY||Odds Ratio (OR)|1.3|||||TWO_SIDED|95.0|0.7|2.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.3|0.7|
71874605|NCT01699789|143267357|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients at 3 years to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
71874606|NCT01699789|143267358|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|1.19|2.59||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.59|1.19|
71874607|NCT01699789|143267359|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.03|2.04||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.04|1.03|
71874608|NCT01699789|143267360|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.14|1.98||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.98|1.14|
71874609|NCT01699789|143267361|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.38|0.96||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.96|0.38|
71874610|NCT01699789|143267362|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.69|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.70|0.69|
71874611|NCT01699789|143267363|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.32|1.09||||||Adjusted analyses used multiply imputed data (N= 249), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||1.09|0.32|
71874612|NCT01699789|143267364|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.51|||||TWO_SIDED|95.0|0.28|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.95|0.28|
71874613|NCT01699789|143267365|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.14|0.88||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.88|0.14|
71874614|NCT01699789|143267366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.81|||||TWO_SIDED|95.0|0.52|1.25|||||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.52|
71874615|NCT01699789|143267367|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.69|1.41||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition||1.41|0.69|
71874616|NCT01699789|143267368|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.7|1.46||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.46|0.70|
71874617|NCT01699789|143267369|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.63|||<|0.01|TWO_SIDED|95.0|1.4|4.94|||Regression, Logistic|||Adjusted analyses used multiply imputed data (N=298), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||4.94|1.40|<.01
71874618|NCT01699789|143267370|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.66|1.21||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.21|0.66|
71874619|NCT01699789|143267371|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.61|1.4||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.40|0.61|
71874620|NCT01699789|143267372|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.34|1.25||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.25|0.34|
71874621|NCT01699789|143267373|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.49|||||TWO_SIDED|95.0|0.3|0.82||||||Adjusted analyses used multiply imputed data (N=553), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||0.82|0.30|
71874622|NCT01699789|143267374|SUPERIORITY||Rate Ratio (RR)|2.84|||||TWO_SIDED|95.0|1.39|5.8||||||Adjusted analyses used multiply imputed data (N=588), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.||5.80|1.39|
71874623|NCT01699789|143267375|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|6.2|||||TWO_SIDED|95.0|1.5|24.9||||||Adjusted analyses used multiply imputed data (N=410), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline and covariates and accounted for the design effect of the cluster randomization.||24.9|1.5|
71874624|NCT01699789|143267376|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.59|1.57||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.57|0.59|
71874625|NCT01699789|143267377|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.4|1.22|||||When analyzed as change from baseline, CEP showed significant reductions in likelihood of behavioral health hospitalizations at 6 months (P \< 0.01) and 12 months (P \< 0.01).|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.22|.40|
71874626|NCT01699789|143267378|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.66||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.66|.66|
71874627|NCT01699789|143267379|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.74|1.42||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a generalized estimating equation logistic regression model adjusted for covariates, accounted for the design effect of the cluster randomization. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.42|0.74|
71874628|NCT01699789|143267380|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.6|1.05||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.05|.60|
71874629|NCT01699789|143267381|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.97|||||TWO_SIDED|95.0|0.72|1.32||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.32|0.72|
71874630|NCT01699789|143267382|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.39||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a logit link function was used with adjustment for covariates.||1.39|0.55|
71874631|NCT01699789|143267383|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio (RR)|0.91|||||TWO_SIDED|95.0|0.65|1.29||||||Intent-to-treat analyses of repeated measures were developed including all participants with data at baseline, 6-month, or 12-month. Missing data were imputed. A generalized estimating equation (GEE) with a log link function was used with adjustment for covariates.||1.29|0.65|
71874632|NCT01699789|143267384|SUPERIORITY||Mean Difference (Final Values)|1.2|||||TWO_SIDED|95.0|0.2|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a linear regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.2|
71874633|NCT01699789|143267385|SUPERIORITY||Rate Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.1|0.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||0.8|0.1|
71874634|NCT01699789|143267386|SUPERIORITY||Rate Ratio (RR)|1.2|||||TWO_SIDED|95.0|0.4|3.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||3.7|0.4|
71874635|NCT01699789|143267387|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.8|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.8|
71874636|NCT01699789|143267388|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.5|2.1||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.1|0.5|
71874637|NCT01699789|143267389|SUPERIORITY||Rate Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.7|1.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.6|0.7|
71916160|NCT03728881|143353736|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.26||||||96.0|1.0|1.58||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.58|1.00|
71916161|NCT03728881|143353736|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.01||||||96.0|0.83|1.24||||||||1.24|0.83|
71916162|NCT03728881|143353736|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.15||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|The p-values test for heterogeneity|||||||=0.15
71874638|NCT01699789|143267390|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.3|4.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||4.0|0.3|
71874639|NCT01699789|143267391|SUPERIORITY||Rate Ratio (RR)|1.1|||||TWO_SIDED|95.0|0.4|2.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.7|0.4|
71874640|NCT01699789|143267392|SUPERIORITY||Rate Ratio (RR)|1.4|||||TWO_SIDED|95.0|0.2|8.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.6|0.2|
71874641|NCT01699789|143267393|SUPERIORITY||Rate Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.4|1.8||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Poisson regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.8|0.4|
71874642|NCT01699789|143267394|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.6|1.2|
71874643|NCT01699789|143267395|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.5||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.5|0.5|
71874644|NCT01699789|143267396|SUPERIORITY||Odds Ratio (OR)|2.9|||||TWO_SIDED|95.0|1.0|8.3||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||8.3|1.0|
71874645|NCT01699789|143267397|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.7|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.7|
71874646|NCT01699789|143267398|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.5|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|0.5|
71874647|NCT01699789|143267399|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|1.0|2.0||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||2.0|1.0|
71874648|NCT01699789|143267400|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline and covariates, and accounted for the design effect of the cluster randomization. We weighted data for 980 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.||1.7|0.6|
71874649|NCT01699789|143267401|SUPERIORITY||Cox Proportional Hazard|1.12|||>|0.05|TWO_SIDED|95.0|0.83|1.5|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.50|0.83|>.05
71874650|NCT01699789|143267402|SUPERIORITY||Cox Proportional Hazard|1.23|||>|0.05|TWO_SIDED|95.0|0.99|1.52|||Regression, Cox|||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a Cox proportional-hazards model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||1.52|0.99|>0.05
71916163|NCT03728881|143353737|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.253||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.253
71874651|NCT01699789|143267403|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|1.0|2.99||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||2.99|1.00|
71874652|NCT01699789|143267404|SUPERIORITY||Odds Ratio (OR)|2.62|||||TWO_SIDED|95.0|1.24|5.54||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using a logistic regression model adjusted for baseline covariates. Data were multiply imputed and weighted for eligible sample for enrollment, accounted for the design effect of the cluster randomization.||5.54|1.24|
71874653|NCT02708095|143267416|SUPERIORITY||Odds Ratio (OR)|1.28||||0.392|TWO_SIDED|95.0|0.73|2.27|||Regression, Logistic|||||2.27|0.73|0.392
71683941|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on believability scores||||>0.05
71916164|NCT03728881|143353737|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.015||||||A p-value under 0.05 will be regarded as significant|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.015
71758552|NCT02205736|143019222|SUPERIORITY|||||||0.0045||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 19 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0045
71874654|NCT02708095|143267416|SUPERIORITY||Odds Ratio (OR)|1.84||||0.041|TWO_SIDED|95.0|1.02|3.29|||Regression, Logistic|||||3.29|1.02|0.041
71874655|NCT02708095|143267417|SUPERIORITY||Odds Ratio, log|1.25||||0.44|TWO_SIDED|95.0|0.71|2.19|||Regression, Logistic|||||2.19|0.71|0.440
71874656|NCT02708095|143267417|SUPERIORITY||Odds Ratio (OR)|2.04||||0.015|TWO_SIDED|95.0|1.15|3.62|||Regression, Logistic|||||3.62|1.15|0.015
71874657|NCT02708095|143267418|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.26||||0.6|TWO_SIDED|95.0|-1.23|0.71|||Mixed Models Analysis|||||0.71|-1.23|0.600
71874658|NCT02708095|143267418|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.58||||0.243|TWO_SIDED|95.0|-1.55|0.39|||Mixed Models Analysis|||||0.39|-1.55|0.243
71874659|NCT02708095|143267419|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.16||||0.285|TWO_SIDED|95.0|-0.45|0.13|||Mixed Models Analysis|||||0.13|-0.45|0.285
71874660|NCT02708095|143267419|SUPERIORITY||LS Mean Difference (Final Vaules)|-0.33||||0.026|TWO_SIDED|95.0|-0.62|-0.04|||Mixed Models Analysis|||||-0.04|-0.62|0.026
71874661|NCT01313650|143267425|SUPERIORITY_OR_OTHER||Least squares mean difference|0.115|||<|0.001|TWO_SIDED|95.0|0.076|0.155|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.155|0.076|<0.001
71874662|NCT01313650|143267425|SUPERIORITY_OR_OTHER||Least squares mean difference|0.072|||<|0.001|TWO_SIDED|95.0|0.032|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.|||0.112|0.032|<0.001
71874663|NCT01313650|143267425|SUPERIORITY_OR_OTHER||Least squares mean difference|0.167|||<|0.001|TWO_SIDED|95.0|0.128|0.207|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.207|0.128|<0.001
71874664|NCT01313650|143267425|SUPERIORITY_OR_OTHER||Least squares mean difference|0.052||||0.004|TWO_SIDED|95.0|0.017|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.|||0.087|0.017|0.004
71874665|NCT01313650|143267425|SUPERIORITY_OR_OTHER||Least squares mean difference|0.095|||<|0.001|TWO_SIDED|95.0|0.06|0.13|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.|||0.130|0.060|<0.001
71874666|NCT00458341|143267449|OTHER|||||||0.133||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.133
71874667|NCT00458341|143267449|OTHER|||||||0.19||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1||||0.190
71874668|NCT00458341|143267449|OTHER|||||||0.123||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.123
71874669|NCT00458341|143267449|OTHER|||||||0.592||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2||||0.592
71874670|NCT00458341|143267450|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
71874671|NCT00458341|143267450|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
71874672|NCT00458341|143267450|OTHER|||||||0.021|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.021
71874673|NCT00458341|143267450|OTHER|||||||0.518|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.||||0.518
71874674|NCT03877432|143267466|SUPERIORITY|||||||0.012|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 1T stimulation amplitude changes on bladder capacity.||||0.012
71683942|NCT03646305|142886282|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on believability||||>0.05
71683943|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appraisal of target thought were equivalent across time.||||<0.001
71683944|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.005|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent across time.||||=0.005
71874675|NCT03877432|143267466|SUPERIORITY|||||||0.017|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 2T stimulation amplitude changes on bladder capacity.||||0.017
71874676|NCT03877432|143267466|SUPERIORITY|||||||0.003|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 3T stimulation amplitude changes on bladder capacity.||||0.003
71874677|NCT03877432|143267466|SUPERIORITY|||||||0.004|||||||ANOVA|||All data were presented as means ± standard deviations (SDs). Analysis of variance (ANOVA) was used to compare the effects of 4T stimulation amplitude changes on bladder capacity.||||0.004
71874678|NCT03471871|143267468|OTHER||Least squares (LS) mean difference|-0.36||||0.099|TWO_SIDED|95.0|-0.78|0.07||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.07|-0.78|0.099
71874679|NCT03471871|143267468|OTHER||LS mean difference|-0.29||||0.176|TWO_SIDED|95.0|-0.72|0.14||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||0.14|-0.72|0.176
71874680|NCT03471871|143267469|OTHER||LS mean difference|-0.06||||0.948|TWO_SIDED|95.0|-1.95|1.83||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.83|-1.95|0.948
71874681|NCT03471871|143267470|OTHER||LS mean difference|0.52||||0.639|TWO_SIDED|95.0|-1.72|2.76||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.76|-1.72|0.639
71874682|NCT03471871|143267470|OTHER||LS mean difference|-1.16||||0.297|TWO_SIDED|95.0|-3.4|1.08||P-Value was at the 0.05 level of significance.|mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||1.08|-3.40|0.297
71874683|NCT03471871|143267471|OTHER||LS mean difference|-0.03||||0.979|TWO_SIDED|95.0|-2.22|2.17||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||||2.17|-2.22|0.979
71874684|NCT03471871|143267472|OTHER||LS mean difference|0.185||||0.095|TWO_SIDED|95.0|-0.034|0.405||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<90%||0.405|-0.034|0.095
71874685|NCT03471871|143267472|OTHER||LS mean difference|0.245||||0.03|TWO_SIDED|95.0|0.025|0.464||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||When SpO2 is \<90%||0.464|0.025|0.030
71874686|NCT03471871|143267472|OTHER||LS mean difference|0.004||||0.885|TWO_SIDED|95.0|-0.058|0.067||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.067|-0.058|0.885
71874687|NCT03471871|143267472|OTHER||LS mean difference|0.044||||0.158|TWO_SIDED|95.0|-0.018|0.107||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<85%||0.107|-0.018|0.158
71874688|NCT03471871|143267472|OTHER||LS mean difference|0.001||||0.462|TWO_SIDED|95.0|-0.002|0.005||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.005|-0.002|0.462
71874689|NCT03471871|143267472|OTHER||LS mean difference|0.002||||0.166|TWO_SIDED|95.0|-0.001|0.006||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is \<80%||0.006|-0.001|0.166
71874690|NCT03471871|143267474|OTHER||LS mean difference|0.07||||0.699|TWO_SIDED|95.0|-0.31|0.46||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: Mean SpO2 during TST||0.46|-0.31|0.699
71874691|NCT03471871|143267474|OTHER||LS mean difference|0.25||||0.169|TWO_SIDED|95.0|-0.11|0.61||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: Mean SpO2 during TST||0.61|-0.11|0.169
71874692|NCT03471871|143267475|OTHER||LS mean difference|0.312||||0.472|TWO_SIDED|95.0|-0.558|1.181||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<90%||1.181|-0.558|0.472
71874693|NCT03471871|143267475|OTHER||LS mean difference|0.067||||0.479|TWO_SIDED|95.0|-0.124|0.258||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<85%||0.258|-0.124|0.479
71874694|NCT03471871|143267475|OTHER||LS mean difference|0.002||||0.852|TWO_SIDED|95.0|-0.019|0.023||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is \<80%||0.023|-0.019|0.852
71874695|NCT03471871|143267475|OTHER||LS mean difference|0.088||||0.733|TWO_SIDED|95.0|-0.431|0.607||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<90%||0.607|-0.431|0.733
71874696|NCT03471871|143267475|OTHER||LSM difference|0.056||||0.518|TWO_SIDED|95.0|-0.117|0.228||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: When SpO2 is \<85%||0.228|-0.117|0.518
71874697|NCT03471871|143267475|OTHER||LS mean difference|0.006||||0.576|TWO_SIDED|95.0|-0.015|0.026||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is \<80%||0.026|-0.015|0.576
71874698|NCT03040622|143267477|OTHER|||||||0.06|||||||ANOVA|||||||0.06
71874699|NCT03040622|143267478|OTHER|||||||0.009|||||||ANOVA|||||||0.009
71916165|NCT03728881|143353739|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.43||||||99.0|0.33|0.55||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.55|0.33|
71874700|NCT03040622|143267479|OTHER|||||||0.001|||||||ANOVA|||||||0.001
71874701|NCT03971422|143267483|SUPERIORITY||LS Mean Difference|-2.586|||<|0.001|TWO_SIDED|95.0|-4.091|-1.249||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||Mixed model repeated measure (MMRM) ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.249|-4.091|<0.001
71874702|NCT03971422|143267483|SUPERIORITY||LS Mean Difference|-2.619|||<|0.001|TWO_SIDED|95.0|-3.994|-1.163||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM analysis of covariance (ANCOVA) model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.163|-3.994|<0.001
71874703|NCT03971422|143267484|SUPERIORITY||Odds Ratio (OR)|5.765|||<|0.001|TWO_SIDED|95.0|2.1|14.882||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||14.882|2.100|<0.001
71874704|NCT03971422|143267484|SUPERIORITY||Odds Ratio (OR)|4.273|||<|0.001|TWO_SIDED|95.0|1.653|11.791||p-value is nominal. Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Wald test||The OR of responder rates is estimated and tested between treatment groups using logistic regression model with treatment group, Baseline MG-ADL score and stratification factor (MuSK+ or AChR+). An OR \> 1 favours rozanolixizumab.|||11.791|1.653|<0.001
71874705|NCT03971422|143267485|SUPERIORITY||LS Mean Difference|-3.901|||<|0.001|TWO_SIDED|95.0|-6.634|-1.245||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.245|-6.634|<0.001
71874706|NCT03971422|143267485|SUPERIORITY||LS Mean Difference|-5.525|||<|0.001|TWO_SIDED|95.0|-8.303|-2.968||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.968|-8.303|<0.001
71874707|NCT03971422|143267486|SUPERIORITY||LS Mean Difference|-3.483|||<|0.001|TWO_SIDED|95.0|-5.614|-1.584||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-1.584|-5.614|<0.001
71874708|NCT03971422|143267486|SUPERIORITY||LS Mean Difference|-4.756|||<|0.001|TWO_SIDED|95.0|-6.821|-2.859||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-2.859|-6.821|<0.001
71874709|NCT03971422|143267487|SUPERIORITY||LS Mean Difference|-12.441|||<|0.001|TWO_SIDED|95.0|-21.804|-4.089||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.089|-21.804|<0.001
71874710|NCT03971422|143267487|SUPERIORITY||LS Mean Difference|-15.163|||<|0.001|TWO_SIDED|95.0|-23.596|-6.45||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-6.450|-23.596|<0.001
71874711|NCT03971422|143267488|SUPERIORITY||LS Mean Difference|-8.65||||0.012|TWO_SIDED|95.0|-18.058|-0.134||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-0.134|-18.058|0.012
71874712|NCT03971422|143267488|SUPERIORITY||LS Mean Difference|-14.822|||<|0.001|TWO_SIDED|95.0|-23.759|-5.936||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-5.936|-23.759|<0.001
71874713|NCT03971422|143267489|SUPERIORITY||LS Mean Difference|-11.32|||<|0.001|TWO_SIDED|95.0|-18.958|-4.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-4.998|-18.958|<0.001
71874714|NCT03971422|143267489|SUPERIORITY||LS Mean Difference|-10.705|||<|0.001|TWO_SIDED|95.0|-17.787|-3.998||Confidence intervals and p-values are based on stage-wise inverse normal combination using the Lehmacher and Wassmer method.|Lehmacher and Wassmer method||MMRM ANCOVA model included treatment group, Baseline score, region, stratification factor (MuSK+ or AChR+) and treatment group by day (interaction term) as fixed factors and participant as a random effect.|A sequential testing procedure was used. The parallel gatekeeping testing procedure with a truncated Hochberg test was used to control the familywise type I error rate at a 2-sided alpha level of 0.05.||-3.998|-17.787|<0.001
71874715|NCT03566810|143267509|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric Least Square(LS)Mean%|98.69|||||TWO_SIDED|90.0|92.2|105.64||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||105.64|92.20|
71916166|NCT03728881|143353739|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.42|||||TWO_SIDED|99.0|0.34|0.52||||||||0.52|0.34|
71916167|NCT03728881|143353739|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.95||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.95
71916168|NCT03728881|143353740|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.||||=1.000
71916169|NCT03728881|143353742|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.91|||||TWO_SIDED|99.0|0.69|1.19||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.19|0.69|
71916170|NCT03728881|143353742|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.89|||||TWO_SIDED|99.0|0.69|1.14||||||||1.14|0.69|
71916171|NCT03728881|143353742|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.88||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.88
71916172|NCT03728881|143353743|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled April - May.|||||=|0.629||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled April - May.||||=0.629
71916173|NCT03728881|143353743|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled June - August.|||||=|0.175||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled June - August.||||=0.175
71916174|NCT03728881|143353745|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.52||||||96.0|0.43|0.64||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||0.64|0.43|
71916175|NCT03728881|143353745|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.48||||||96.0|0.4|0.58||||||||0.58|0.40|
71916176|NCT03728881|143353745|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.46||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.46
71916177|NCT03728881|143353746|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
71874716|NCT03566810|143267509|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|99.39|||||TWO_SIDED|90.0|93.15|106.05||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||106.05|93.15|
71874717|NCT03566810|143267510|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.92|||||TWO_SIDED|90.0|91.08|107.44||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||107.44|91.08|
71874718|NCT03566810|143267510|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|96.89|||||TWO_SIDED|90.0|89.87|104.46||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.46|89.87|
71874719|NCT03566810|143267511|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.0||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||0.00|-0.50|
71874720|NCT03566810|143267511|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||TWO_SIDED|90.0|-0.5|0.5||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||0.50|-0.50|
71874721|NCT03566810|143267513|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|97.89|||||TWO_SIDED|90.0|91.38|104.86||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.||104.86|91.38|
71874722|NCT03566810|143267513|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.08|||||TWO_SIDED|90.0|92.37|104.14||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.||104.14|92.37|
71874723|NCT00826111|143267550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0085|STANDARD_ERROR_OF_MEAN|0.0534||0.88|TWO_SIDED|95.0|-0.139|0.0122|||t-test, 2 sided|||||.01220|-0.1390|0.88
71874724|NCT00826111|143267551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.112||0.79|TWO_SIDED|95.0|-0.286|0.224|||t-test, 2 sided|||||0.224|-0.286|0.79
71874725|NCT00826111|143267552|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.0222|STANDARD_ERROR_OF_MEAN|0.0128||0.16|TWO_SIDED|95.0|-0.58|0.0136|||t-test, 2 sided|||||.0136|-0.580|0.16
71874726|NCT00826111|143267553|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.515||0.29|TWO_SIDED|95.0|-1.35|2.77|||t-test, 2 sided|||||2.77|-1.35|0.29
71874727|NCT00826111|143267554|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0048|STANDARD_ERROR_OF_MEAN|0.005||0.37|TWO_SIDED|95.0|-0.0077|0.0174|||t-test, 2 sided|||||0.0174|-0.0077|0.37
71874728|NCT00826111|143267555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0056|STANDARD_ERROR_OF_MEAN|0.0042||0.21|TWO_SIDED|95.0|-0.0037|0.1481|||t-test, 2 sided|||||0.1481|-0.0037|0.21
71874729|NCT00826111|143267556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.35|STANDARD_ERROR_OF_MEAN|3.94||0.1|TWO_SIDED|95.0|-1.76|16.46|||t-test, 2 sided|||||16.46|-1.76|0.10
71874730|NCT00826111|143267557|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|4.06||0.89|TWO_SIDED|95.0|-9.31|10.51|||t-test, 2 sided|||||10.51|-9.31|0.89
71874731|NCT00826111|143267558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|3.78||0.66|TWO_SIDED|95.0|-10.31|6.91|||t-test, 2 sided|||||6.91|-10.31|0.66
71916178|NCT03728881|143353748|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|1.27||||||96.0|1.03|1.57||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.57|1.03|
71874732|NCT01672788|143267559|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.31|STANDARD_DEVIATION|10.7|||TWO_SIDED|90.0|96.89|105.93|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.93|96.89|
71874733|NCT01672788|143267559|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.3|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.4|103.29|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||103.29|97.40|
71874734|NCT01672788|143267560|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose.|Geometric Mean Ratio|101.61|STANDARD_DEVIATION|8.8|||TWO_SIDED|90.0|97.94|105.41|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||105.41|97.94|
71874735|NCT01672788|143267560|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|98.56|STANDARD_DEVIATION|10.8|||TWO_SIDED|90.0|94.24|103.08|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.08|94.24|
71874736|NCT01672788|143267561|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.2|STANDARD_DEVIATION|10.4|||TWO_SIDED|90.0|96.89|105.71|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.71|96.89|
71874737|NCT01672788|143267561|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.31|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|97.41|103.3|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||103.30|97.41|
71874738|NCT01672788|143267562|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|102.7|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|98.75|106.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||106.81|98.75|
71874739|NCT01672788|143267562|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.97|STANDARD_DEVIATION|12.3|||TWO_SIDED|90.0|95.94|106.27|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||106.27|95.94|
71874740|NCT01672788|143267563|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|99.64|STANDARD_DEVIATION|10.5|||TWO_SIDED|90.0|95.39|104.09|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||104.09|95.39|
71874741|NCT01672788|143267563|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|10.2|||TWO_SIDED|90.0|93.82|102.15|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.15|93.82|
71874742|NCT01672788|143267564|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|101.51|STANDARD_DEVIATION|8.6|||TWO_SIDED|90.0|97.95|105.21|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the geometric coefficient of variation (gCV)|||105.21|97.95|
71874743|NCT01672788|143267564|NON_INFERIORITY_OR_EQUIVALENCE|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose .|Geometric Mean Ratio|98.57|STANDARD_DEVIATION|10.1|||TWO_SIDED|90.0|94.5|102.81|||ANOVA|Based on an ANOVA including the random effect subjects within sequences and the fixed effects sequence, period and treatment.|Standard deviation is actually the gCV|||102.81|94.50|
71874744|NCT02445196|143267565|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.57||||0.035|TWO_SIDED||||||ANOVA|||Repeated measures ANOVAs assessed the condition by time (baseline to posttreatment) interaction effects covarying PTSD treatment. Following the ITT principle, data from all randomized participants were analyzed and multiple imputation replaced missing values. A power analysis indicated that to achieve 80% power to detect an effect size in the magnitude (i.e., d = 0.25 to .33) with alpha of .05 and a correlation between repeated measures of .5, 60 participants per condition would be needed.||||.035
71874745|NCT02445196|143267566|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.87||||0.086|TWO_SIDED||||||ANOVA|||||||.086
71874746|NCT02445196|143267567|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.007|TWO_SIDED||||||ANOVA|||||||.007
71874747|NCT02445196|143267568|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.72||||0.005|TWO_SIDED||||||ANOVA|||||||.005
71874748|NCT02445196|143267569|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.78||||0.113|TWO_SIDED||||||t-test, 2 sided|||||||.113
71874749|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.026||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R' and represented in the text as adjusted p-value.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60 years and \>/= 60 years) to facilitate comparison.||||0.026
71874750|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.496||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on adiponectin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||0.496
71874751|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05|||||||Regression, Linear|||The influence of age on leptin levels was analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
71874752|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
71916179|NCT03728881|143353748|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 36 months the lower limit of the two-sided 96% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.)|GMC Ratio|0.99||||||96.0|0.8|1.23||||||||1.23|0.80|
71916180|NCT03728881|143353748|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.095||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.095
71874753|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of age on IGF1 and 2 levels were analysed by dividing the population into binary groups (\<60years and \>/=60years) to facilitate comparison.||||>0.05
71916181|NCT03728881|143353749|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|0.327||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=0.327
71916182|NCT03728881|143353749|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.012||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.012
71916183|NCT03728881|143353751|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.45|||||TWO_SIDED|99.0|0.36|0.58||||||||0.58|0.36|
71916184|NCT03728881|143353751|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.4|||||TWO_SIDED|99.0|0.32|0.5||||||||0.50|0.32|
71916185|NCT03728881|143353751|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.3||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.30
71916186|NCT03728881|143353752|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
71916187|NCT03728881|143353754|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|1.02||||||99.0|0.79|1.32||||||This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.||1.32|0.79|
71916188|NCT03728881|143353754|NON_INFERIORITY|Let R=GMC1/GMC3 be the ratio of geometric mean concentrations of 1 dose to 3 doses. We reject the noninferiority hypothesis if at 24 months the lower limit of the two-sided 99% confidence interval on R ≥ 0.67 for HPV16 and HPV18. The overall Type 1 error rate for rejecting the null hypotheses for both HPV16 and HPV18 (i.e., declaring noninferiority of the 1D2V) at either time point was controlled at 0.025.|GMC Ratio|0.81||||||99.0|0.63|1.04||||||||1.04|0.63|
71916189|NCT03728881|143353754|EQUIVALENCE|The p-values test for heterogeneity in the GMC ratios estimated from the stratified analyses.|||||=|0.1||||||A p-value \<0.05 is interpreted as significantly different GMC ratios in different strata.|p-values test for heterogeneity|||||||=0.10
71916190|NCT03728881|143353755|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from coastal districts.|||||=|1||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.||||=1.000
71916191|NCT03728881|143353755|EQUIVALENCE|We will use a Fisher Exact test to test for the difference of the seroconversion rate between one-dose and three-dose recipients enrolled from mountainous districts.|||||=|0.339||||||A p-value under 0.05 will be regarded as significant.|Fisher Exact|||The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.||||=0.339
71916192|NCT04088331|143353837|SUPERIORITY||||||<|0.001|||||||Exact binomial test|||"Hypotheses:~H0: p ≤ 0.65 H1: p \> 0.65 where p = the proportion of subjects who are a treatment success.~Hypotheses evaluated using a one-sided exact binomial test.~Power calculation assumed a treatment success rate of 80%. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size of 96 subjects needed to demonstrate the proportion of subjects who are a treatment success exceeds 65%."||||< 0.001
71916193|NCT05505734|143353847|SUPERIORITY||Hazard Ratio (HR)|0.535|||<|0.001|TWO_SIDED|95.0|0.392|0.73||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values are estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.730|0.392|<0.001
71916194|NCT05505734|143353848|SUPERIORITY||Hazard Ratio (HR)|0.539|||<|0.001|TWO_SIDED|95.0|0.397|0.733||The pre-specified alpha (type I error) at the IA was set at 0.003 for the primary and first secondary endpoint|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.733|0.397|<0.001
71916195|NCT05505734|143353849|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.405|0.724||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.724|0.405|<0.001
71916196|NCT05505734|143353850|SUPERIORITY||Hazard Ratio (HR)|0.541|||<|0.001|TWO_SIDED|95.0|0.406|0.72||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Regression, Cox|||Hazard ratios, 95% confidence intervals for hazard ratios and p-values were estimated using a Cox regression model with treatment group, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A hazard ratio less than 1 favors the BDA MDI treatment group.||0.720|0.406|<0.001
71683945|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.002|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in negativity from baseline to post-intervention||||=0.002
71683946|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in negativity from post-intervention to follow-up.||||<0.001
71874754|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin, leptin, IGF1 and 2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||>0.05
71874755|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.014||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of adiponectin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.014
71874756|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.006||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of leptin was analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.006
71874757|NCT04697264|143267594|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.019||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||The influence of menopausal status on levels of IGF1 and IGF2 were analysed by dividing the population into binary groups (pre-menopausal and menopausal) to facilitate comparison.||||0.019
71874758|NCT04697264|143267595|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.033||||||Adjustments to the p-values for multiple comparison were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of LVSI on adiponectin levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of LVSI) to facilitate comparisons.||||0.033
71874759|NCT04697264|143267595|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.||||||0.015||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of MELF on TNF levels were assessed using multivariate linear regression, with binary categorisations (presence and absence of MELF) to facilitate comparisons.||||0.015
71874760|NCT04697264|143267595|OTHER|Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis.|||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Regression, Linear|||Effects of tumour grade (Grade 1/2), stage (Stage 1/ \>/=1), histology (type 1 and type 2), and MSI (presence or absence) on the biomarker levels (adiponectin, leptin, IGF 1 and 2, IL6 and TNF) were assessed using multivariate linear regression, with binary categorisations to facilitate comparisons.||||>0.05
71874761|NCT04697264|143267596|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.0001
71874762|NCT04697264|143267597|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||>0.05
71874763|NCT04697264|143267598|OTHER||||||<|0.05||||||Adjustments to the p-values for multiple comparison were performed using the Benjamini and Hochberg approach in 'R'.|Regression, Linear|||To compare biomarker levels between study and control populations, a linear regression model was used, adjusting for BMI, diabetes, and parity, which are the unmatched factors between the study and control groups. This adjustment aimed to mitigate the confounding impact of these factors, considering their individual influence on the risk of endometrial cancer.||||<0.05
71874764|NCT04697264|143267599|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the study population at baseline."||||>0.05
71874765|NCT04697264|143267599|OTHER|||||||0.09||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the study population at baseline."||||0.09
71874766|NCT04697264|143267599|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the association between IL6, TNFα, IGF1, and IGF2 and the BMI of the study population at baseline."||||>0.05
71874767|NCT04697264|143267600|OTHER|||||||0.004||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between adiponectin and the BMI of the control population at baseline."||||0.004
71874768|NCT04697264|143267600|OTHER|||||||0.0002||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between leptin and the BMI of the control population at baseline."||||0.0002
71874769|NCT04697264|143267600|OTHER||||||>|0.05||||||Univariate linear regression was initially performed, followed by multivariate regression using the significant associations from the univariate analysis. P value \<0.05 was considered significant.|Regression, Linear|||"The impact of BMI on biomarker levels was assessed by categorising the population into two groups-normal weight and overweight/obese-for straightforward comparison.~Here, we present the associations between IL6, TNFα, IGF1, and IGF2 and the BMI of the control population at baseline."||||>0.05
71874770|NCT04697264|143267601|OTHER|||||||0.0007||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||||||0.0007
71874771|NCT04697264|143267602|OTHER||||||>|0.05||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||Leptin levels were compared between the day 0 and 6 months post-operative bloods.||||>0.05
71874772|NCT04697264|143267602|OTHER|||||||0.004||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF1 levels were compared between the day 0 and 6 months post-operative bloods.||||0.004
71874773|NCT04697264|143267602|OTHER||||||<|0.0001||||||Adjustments to the p-values for multiple comparisons were performed using Benjamini and Hochberg approach on 'R'.|Mixed Models Analysis|||IGF2 levels were compared between the day 0 and 6 months post-operative bloods.||||<0.0001
71874774|NCT04697264|143267604|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.0001
71874775|NCT04697264|143267604|OTHER||||||<|0.05|||||||t-test, 2 sided|||Expression of leptin and their receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||<0.05
71874776|NCT04697264|143267604|OTHER||||||>|0.05|||||||t-test, 2 sided|||Expression of adiponectin receptors were studied in endometrial cancer tissue and fat tissue using qRT-PCR.||||>0.05
71874777|NCT04697264|143267605|OTHER|||||||0.0002|||||||t-test, 2 sided|||Expression of adiponectin was studied in endometrial cancer tissue and lymph node tissue using qRT-PCR.||||0.0002
71874778|NCT04697264|143267605|OTHER|||||||0.011|||||||t-test, 2 sided|||Expression of leptin was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.011
71874779|NCT04697264|143267605|OTHER|||||||0.009|||||||t-test, 2 sided|||The expression of IL6 receptor (IL6R) was studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||0.009
71874780|NCT04697264|143267605|OTHER||||||>|0.05|||||||t-test, 2 sided|||The expression of adiponectin receptor, leptin receptor, IGF1 and IGF 2 receptors, IL6, TNF, IGF1 and IGF2 were studied in endometrial cancer tissue and lymphnode tissue using qRT-PCR.||||>0.05
71874781|NCT04697264|143267606|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating adiponectin levels and the expression of these markers and their receptors in endometrial tissue were compared using correlation studies.||||>0.05
71874782|NCT04697264|143267607|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating leptin, IGF1 and IGF2 levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
71874783|NCT04697264|143267608|OTHER||||||>|0.05|||||||Pearson's correlation test|||Circulating IL6 and TNF levels and the expression of these markers and their receptors in endometrial tissue were compared using Pearson's correlation studies.||||>0.05
71683947|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in negativity from baseline to post-intervention. Null hypothesis: there would be no significant difference in negativity scores from baseline to post-intervention in the experimental conditions||||>0.025
71916197|NCT05505734|143353851|SUPERIORITY||Rate Ratio|0.47|||<|0.001|TWO_SIDED|95.0|0.34|0.64||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.64|0.34|<0.001
71916198|NCT05505734|143353852|SUPERIORITY||Rate Ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.33|0.63||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Negative binomial|||Rates, rate ratios and two-sided p-values were estimated from a negative binomial model with treatment, pre-study asthma therapy, and number of severe exacerbations in the last 12 months prior to randomization as factors. A rate ratio less than 1 favors BDA MDI treatment group.||0.63|0.33|<0.001
71916199|NCT05505734|143353853|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
71916200|NCT05505734|143353854|SUPERIORITY||||||<|0.001||||||The pre-specified type I error for secondary endpoints tested at the final DCO was 0.05. A hierarchical testing strategy was employed to control the two-sided Type I error rate for the secondary endpoints, excluding the first secondary endpoint.|Wilcoxon rank sum|||||||<0.001
71916201|NCT00976963|143353873|NON_INFERIORITY|The equivalence margin for non-inferiority of Fosfomycin to TMP/SMX is 10%.|||||<|0.001|||||||Wald test for noninferiority|||The null hypothesis is that Fosfomycin is inferior to TMP/SMX.||||<0.001
71916202|NCT03369704|143353885|OTHER||Least Square Mean|-1.03|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.44|-0.62||"H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.~H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period."|ANCOVA||nasal symptom score|||-0.62|-1.44|<0.001
71916203|NCT03369704|143353886|OTHER||ANCOVA|-1.89|STANDARD_ERROR_OF_MEAN|0.331|||TWO_SIDED|95.0|-2.55|-1.24|||||Nasal Ocular Symptom|||-1.24|-2.55|
71916204|NCT03369704|143353886|OTHER||ANCOVA|-0.87|STANDARD_ERROR_OF_MEAN|0.159|||TWO_SIDED|95.0|-1.18|-0.55|||||Ocular symptom|||-0.55|-1.18|
71916205|NCT03369704|143353887|OTHER||ANCOVA|-1.1|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|95.0|-1.55|-0.64|||||nasal symptom medication score|||-0.64|-1.55|
71916206|NCT03369704|143353887|OTHER||ANCOVA|-0.95|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|95.0|-1.32|-0.58|||||ocular symptom medication score|||-0.58|-1.32|
71916207|NCT03369704|143353887|OTHER||ANCOVA|-2.05|STANDARD_ERROR_OF_MEAN|0.375|||TWO_SIDED|95.0|-2.78|-1.31|||||nasal ocular symptom medication score|||-1.31|-2.78|
71916208|NCT03369704|143353888|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.073|||TWO_SIDED|95.0|-0.54|-0.26|||||sneezing score|||-0.26|-0.54|
71916209|NCT03369704|143353888|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.088|||TWO_SIDED|95.0|-0.51|-0.16|||||rhinorrhea score|||-0.16|-0.51|
71916210|NCT03369704|143353888|OTHER||ANCOVA|-0.29|STANDARD_ERROR_OF_MEAN|0.081|||TWO_SIDED|95.0|-0.45|-0.13|||||nasal congestion score|||-0.13|-0.45|
71916211|NCT03369704|143353889|OTHER||ANCOVA|-0.47|STANDARD_ERROR_OF_MEAN|0.084|||TWO_SIDED|95.0|-0.63|-0.3|||||itchy eye score|||-0.30|-0.63|
71916212|NCT03369704|143353889|OTHER||ANCOVA|-0.4|STANDARD_ERROR_OF_MEAN|0.087|||TWO_SIDED|95.0|-0.57|-0.23|||||watery eye score|||-0.23|-0.57|
71916213|NCT03369704|143353890|OTHER||ANCOVA|-0.34|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.48|-0.2|||||score for impairment of daily activities|||-0.20|-0.48|
71916214|NCT03369704|143353891|OTHER||Hodges-Lehmann Estimate|3.0|STANDARD_ERROR_OF_MEAN|1.02||0.005|TWO_SIDED|95.0|1.0|5.0|||van Elteren test||Nasal symptom free days|||5.0|1.0|0.005
71916215|NCT03369704|143353891|OTHER||Hodges-Lehmann Estimate|4.0|STANDARD_ERROR_OF_MEAN|1.15|<|0.001|TWO_SIDED|95.0|2.0|6.5|||van Elteren test||Ocular symptom free days|||6.5|2.0|<0.001
71916216|NCT03369704|143353892|OTHER||Odds Ratio (OR)|3.43||||0.005|TWO_SIDED|95.0|1.21|9.75|||logistic regression||Completely nasal symptom free patients|||9.75|1.21|0.005
71916217|NCT03369704|143353893|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.033|||TWO_SIDED|95.0|-0.14|-0.01|||||Nasal rescue mediation score|||-0.01|-0.14|
71916218|NCT03369704|143353893|OTHER||ANCOVA|-0.08|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|-0.16|0.0|||||Ocular rescue medication score|||0.00|-0.16|
71916219|NCT03369704|143353893|OTHER||ANCOVA|-0.16|STANDARD_ERROR_OF_MEAN|0.063|||TWO_SIDED|95.0|-0.28|-0.04|||||Nasal ocular rescue medication score|||-0.04|-0.28|
71916220|NCT03369704|143353894|OTHER||Hodges-Lehmann Estimate|1.5|STANDARD_ERROR_OF_MEAN|0.89||0.011|TWO_SIDED|95.0|0.0|3.5|||van Elteren test||Nasal rescue mediation free days|||3.5|0.0|0.011
71916221|NCT03369704|143353894|OTHER||Hodges-Lehmann Estimate|2.0|STANDARD_ERROR_OF_MEAN|1.21||0.074|TWO_SIDED|95.0|0.0|4.8|||van Elteren test||Ocular rescue medication free days|||4.8|0.0|0.074
71916222|NCT03369704|143353894|OTHER||Hodges-Lehmann Estimate|1.8|STANDARD_ERROR_OF_MEAN|1.02||0.098|TWO_SIDED|95.0|0.0|4.0|||van Elteren test||Nasal ocular rescue medication free days|||4.0|0.0|0.098
71916223|NCT03369704|143353895|OTHER||Hodges-Lehmann Estimate|-2.0|STANDARD_ERROR_OF_MEAN|1.15||0.006|TWO_SIDED|95.0|-4.5|0.0|||van Elteren test||Nasal rescue mediation used|||0.0|-4.5|0.006
71916224|NCT03369704|143353895|OTHER||Hodges-Lehmann Estimate|-7.0|STANDARD_ERROR_OF_MEAN|2.81||0.012|TWO_SIDED|95.0|-12.0|-1.0|||van Elteren test||Ocular rescue medication used|||-1.0|-12.0|0.012
71916225|NCT03369704|143353896|OTHER||ANCOVA|-0.5|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|-0.66|-0.33|||||JRQLQ I|||-0.33|-0.66|
71874784|NCT01681628|143267673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.9|STANDARD_ERROR_OF_MEAN|2.0|<|0.001|TWO_SIDED|95.0|16.1|24.0||This was an a priori threshold.|t-test, 2 sided|||Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.||24.0|16.1|<0.001
71874785|NCT01681628|143267673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.4|STANDARD_DEVIATION|14.7|<|0.001|TWO_SIDED|95.0|29.1|34.7|||t-test, 2 sided|||Change in PCL-C scores from before to after treatment.||34.7|29.1|<0.001
71874786|NCT01681628|143267673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_DEVIATION|14.2|<|0.001|TWO_SIDED|95.0|11.4|17.1|||t-test, 2 sided|||Changes in PCL-C scores for control group after no treatment.||17.1|11.4|<0.001
71874787|NCT01681628|143267673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|STANDARD_DEVIATION|13.5|<|0.001|TWO_SIDED|95.0|17.1|22.5|||t-test, 2 sided|Degrees of freedom 94||Change in control group PCL-C scores after treatment, that is from time 2 to time 3.||22.5|17.1|<0.001
71874788|NCT01681628|143267674|SUPERIORITY_OR_OTHER||percentage of participants|65.7|||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-squared test of any change in PCL-C from time 1 to time 2.||||<0.001
71874789|NCT01681628|143267674|SUPERIORITY_OR_OTHER||% of participants with PCL score > 50|41.0|||<|0.001|TWO_SIDED||||||Chi-squared|||Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.||||<0.001
71916226|NCT03369704|143353896|OTHER||ANCOVA|-0.51|STANDARD_ERROR_OF_MEAN|0.093|||TWO_SIDED|95.0|-0.69|-0.33|||||JRQLQ II|||-0.33|-0.69|
71916227|NCT03369704|143353896|OTHER||ANCOVA|-0.6|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.8|-0.4|||||JRQLQ III|||-0.4|-0.8|
71916228|NCT02148952|143353903|SUPERIORITY|We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.|Risk Ratio (RR)|0.99||||0.9|TWO_SIDED|95.0|0.83|1.18|||Chi-squared, Corrected|In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.|Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.18|0.83|0.90
71916229|NCT02148952|143353904|SUPERIORITY||Risk Ratio (RR)|1.03||||0.67|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.20|0.89|0.67
71916230|NCT02148952|143353905|SUPERIORITY||Risk Ratio (RR)|1.03||||0.68|TWO_SIDED|95.0|0.89|1.2|||Chi-squared, Corrected|||||1.20|0.89|0.68
71916231|NCT02148952|143353906|SUPERIORITY||Risk Ratio (RR)|0.94||||0.56|TWO_SIDED|95.0|0.76|1.16|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.16|0.76|0.56
71916232|NCT02148952|143353907|SUPERIORITY||Risk Ratio (RR)|1.1||||0.19|TWO_SIDED|95.0|0.95|1.27|||Chi-squared, Corrected|||||1.27|0.95|0.19
71874790|NCT01681628|143267674|SUPERIORITY_OR_OTHER||Percentage|39.9|||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71874791|NCT01681628|143267675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.8|||<|0.001|TWO_SIDED|95.0|15.2|20.5|||t-test, 2 sided|||Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.||20.5|15.2|<0.001
71874792|NCT04682977|143267709|SUPERIORITY||Mean difference (adjusted)|1.58|STANDARD_ERROR_OF_MEAN|0.76||0.04|TWO_SIDED|||||Sidak correction for multiple comparisons.|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.04
71874793|NCT04682977|143267710|SUPERIORITY||Mean difference (adjusted)|1.98|STANDARD_ERROR_OF_MEAN|1.75||0.26|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.26
71874794|NCT04682977|143267711|SUPERIORITY||Mean difference (adjusted)|-1.06|STANDARD_ERROR_OF_MEAN|1.6||0.51|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF-Control|||||0.51
71874795|NCT04682977|143267712|SUPERIORITY||Mean difference (adjusted)|2.17|STANDARD_ERROR_OF_MEAN|1.78||0.23|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.23
71874796|NCT04682977|143267713|SUPERIORITY||Mean difference (adjusted)|4.65|STANDARD_ERROR_OF_MEAN|5.97||0.44|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.44
71874797|NCT04682977|143267714|SUPERIORITY||Mean difference (adjusted)|4.37|STANDARD_ERROR_OF_MEAN|3.47||0.22|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.22
71874798|NCT04682977|143267715|SUPERIORITY||Mean difference (adjusted)|0.91|STANDARD_ERROR_OF_MEAN|1.8||0.91|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.91
71874799|NCT04682977|143267716|SUPERIORITY||Mean difference (adjusted)|0.18|STANDARD_ERROR_OF_MEAN|0.65||0.78|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.78
71874800|NCT04682977|143267717|SUPERIORITY||Mean difference (adjusted)|-0.12|STANDARD_ERROR_OF_MEAN|0.53||0.83|TWO_SIDED|||||Sidak correction for multiple comparisons|ANCOVA|ANCOVA with baseline score as covariate Effect size calculated using Cohen's d|Treatment Difference = IPROACTIF - Control|||||0.83
71874801|NCT04682977|143267718|SUPERIORITY|||||||0.67||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.67
71874802|NCT04682977|143267719|SUPERIORITY|||||||0.77||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.77
71874803|NCT04682977|143267720|SUPERIORITY|||||||0.79||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.79
71874804|NCT04682977|143267721|SUPERIORITY|||||||0.44||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.44
71874805|NCT04682977|143267722|SUPERIORITY|||||||0.65||||||The threshold for statistical significance was p = 0.05|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r||||||0.65
71874806|NCT04682977|143267723|SUPERIORITY|||||||0.66||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.66
71874807|NCT04682977|143267724|SUPERIORITY|||||||0.81||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.81
71874808|NCT04682977|143267725|SUPERIORITY|||||||0.89||||||The threshold for statistical significance was p = 0.05.|Wilcoxon (Mann-Whitney)|A non-parametric test was used due to non-normal distribution of data. Effect size calculated using rank biserial correlation r.||||||0.89
71874809|NCT02876835|143267819|NON_INFERIORITY|Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.89|1.19|||||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|
71874810|NCT02876835|143267820|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than -0.75 g/dL.|Least square (LS) mean difference|0.08|||||TWO_SIDED|95.0|0.03|0.13||||||||0.13|0.03|
71874811|NCT02876835|143267821|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.670884|TWO_SIDED|95.0|0.89|1.19||The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.19|0.89|0.670884
71874812|NCT02876835|143267822|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.800813|TWO_SIDED|95.0|0.93|1.22||The p-value was compared against 0.012500 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.93|0.800813
71874813|NCT02876835|143267823|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.886195|TWO_SIDED|95.0|0.95|1.24||The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.|Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.24|0.95|0.886195
71916233|NCT02148952|143353908|SUPERIORITY||Risk Ratio (RR)|1.11||||0.73|TWO_SIDED|95.0|0.74|1.53|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.53|0.74|0.73
71874814|NCT02876835|143267824|SUPERIORITY||Subdistribution hazard ratio|0.98||||0.36947|TWO_SIDED|95.0|0.84|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.84|0.369470
71874815|NCT02876835|143267825|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6197|TWO_SIDED|95.0|0.87|1.2|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.20|0.87|0.6197
71874816|NCT02876835|143267826|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8976|TWO_SIDED|95.0|0.91|1.58|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.58|0.91|0.8976
71874817|NCT02876835|143267827|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.6581|TWO_SIDED|95.0|0.8|1.4|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.40|0.80|0.6581
71916234|NCT02148952|143353909|SUPERIORITY||Risk Ratio (RR)|0.97||||0.81|TWO_SIDED|95.0|0.79|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate any severe maternal complication within 7 days||1.20|0.79|0.81
71916235|NCT02148952|143353909|SUPERIORITY||Risk Ratio (RR)|0.89||||0.76|TWO_SIDED|95.0|0.57|1.52|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of seizures||1.52|0.57|0.76
71916236|NCT02148952|143353909|SUPERIORITY||Risk Ratio (RR)|0.98||||0.97|TWO_SIDED|95.0|0.7|1.41|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of loss of consciousness for \> 1 hr||1.41|0.70|0.97
71916237|NCT02148952|143353909|SUPERIORITY||Risk Ratio (RR)|1.02||||0.9|TWO_SIDED|95.0|0.76|1.38|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of high fever with foul-smelling vaginal discharge||1.38|0.76|0.90
71916238|NCT02148952|143353909|SUPERIORITY||Risk Ratio (RR)|0.95||||0.61|TWO_SIDED|95.0|0.77|1.17|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of hemorrhage||1.17|0.77|0.61
71916239|NCT02148952|143353909|SUPERIORITY||Risk Ratio (RR)|0.5||||0.41|TWO_SIDED|95.0|0.34|1.58|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of stroke||1.58|0.34|0.41
71916240|NCT02148952|143353910|SUPERIORITY||Risk Ratio (RR)|1.07||||0.74|TWO_SIDED|95.0|0.72|1.58|||Chi-squared, Corrected|||||1.58|0.72|0.74
71916241|NCT02148952|143353911|SUPERIORITY||Risk Ratio (RR)|1.09||||0.57|TWO_SIDED|95.0|0.81|1.47|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.47|0.81|0.57
71916242|NCT02148952|143353912|SUPERIORITY||Risk Ratio (RR)|1.19||||0.41|TWO_SIDED|95.0|0.78|1.8|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.80|0.78|0.41
71916243|NCT02148952|143353913|SUPERIORITY||Risk Ratio (RR)|1.0||||0.95|TWO_SIDED|95.0|0.45|2.13|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||2.13|0.45|0.95
71916244|NCT02148952|143353914|SUPERIORITY||Risk Ratio (RR)|0.99||||0.97|TWO_SIDED|95.0|0.69|1.43|||Chi-squared, Corrected|||||1.43|0.69|0.97
71916245|NCT02148952|143353915|SUPERIORITY||Risk Ratio (RR)|0.91||||0.32|TWO_SIDED|95.0|0.76|1.1|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.10|0.76|0.32
71916246|NCT02148952|143353916|SUPERIORITY||Risk Ratio (RR)|0.92||||0.3|TWO_SIDED|95.0|0.78|1.08|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|||1.08|0.78|0.30
71916247|NCT02148952|143353917|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71916248|NCT02148952|143353918|SUPERIORITY||Other|0.0||||0.18|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Birth Companion Present||||0.18
71916249|NCT02148952|143353918|SUPERIORITY||Risk Ratio (RR)|9.8|||<|0.001|TWO_SIDED|95.0|3.4|28.3|||Chi-squared, Corrected|||Maternal blood pressure taken||28.3|3.4|<0.001
71916250|NCT02148952|143353918|SUPERIORITY||Risk Ratio (RR)|132.0|||<|0.001|TWO_SIDED|95.0|26.9|645.0|||Chi-squared, Corrected|||Maternal temperature taken||645|26.9|<0.001
71916251|NCT02148952|143353918|SUPERIORITY||Risk Ratio (RR)|7.3||||0.01|TWO_SIDED|95.0|1.5|35.6|||Chi-squared, Corrected|||Partography started||35.6|1.5|0.01
71916252|NCT02148952|143353918|SUPERIORITY||Risk Ratio (RR)|413.0|||<|0.001|TWO_SIDED|95.0|65.8|2589.0|||Chi-squared, Corrected|||Checklist use||2589|65.8|<0.001
71916253|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|53.3|||<|0.001|TWO_SIDED|95.0|13.1|217.0|||Chi-squared, Corrected|||Hand hygiene||217|13.1|<0.001
71916254|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|2.3||||0.007|TWO_SIDED|95.0|1.3|4.2|||Chi-squared, Corrected|||No oxytocin given before delivery||4.2|1.3|0.007
71916255|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|5.7|||<|0.001|TWO_SIDED|95.0|2.7|12.1|||Chi-squared, Corrected|||Clean towel available||12.1|2.7|<0.001
71916256|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|1.1||||0.72|TWO_SIDED|95.0|0.7|1.7|||Chi-squared, Corrected|||Clean scissors or blade available||1.7|0.7|0.72
71916257|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|1.0||||0.48|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.48
71916258|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|1.0||||0.73|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|0.9|0.73
71916259|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|1.0||||0.56|TWO_SIDED|95.0|0.9|1.1|||Chi-squared, Corrected|||Neonatal bag and mask available||1.1|0.9|0.56
71916260|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|2.1||||0.005|TWO_SIDED|95.0|1.3|3.5|||Chi-squared, Corrected|||Pads available||3.5|1.3|0.005
71916261|NCT02148952|143353919|SUPERIORITY||Risk Ratio (RR)|185.0|||<|0.001|TWO_SIDED|95.0|19.7|1738.0|||Chi-squared, Corrected|||Checklist use||1738|19.7|<0.001
71916262|NCT02148952|143353920|SUPERIORITY||Risk Ratio (RR)|3.9|||<|0.001|TWO_SIDED|95.0|2.1|7.2|||Chi-squared, Corrected|||Oxytocin administered||7.2|2.1|<0.001
71916263|NCT02148952|143353920|SUPERIORITY||Risk Ratio (RR)|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Chi-squared, Corrected|||Neonatal bag used||1.4|0.3|0.25
71916264|NCT02148952|143353920|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth attendant present||1.0|1.0|0.25
71916265|NCT02148952|143353921|SUPERIORITY||Risk Ratio (RR)|1.1||||0.25|TWO_SIDED|95.0|0.9|1.4|||Chi-squared, Corrected|||Newborn weight taken||1.4|0.9|0.25
71683948|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.025|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in negativity from post-intervention to follow-up. Null hypothesis: the experimental conditions would have no significant difference in negativity scores from post-intervention to follow-up.||||>0.025
71874818|NCT02876835|143267828|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.894|TWO_SIDED|95.0|0.85|2.07|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||2.07|0.85|0.8940
71874819|NCT02876835|143267829|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.9422|TWO_SIDED|95.0|0.98|1.23|||Chi-squared||Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.|||1.23|0.98|0.9422
71758553|NCT02205736|143019222|SUPERIORITY|||||||0.9068||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 20 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.9068
71874820|NCT02876835|143267829|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
71874821|NCT02876835|143267829|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.6789|TWO_SIDED|95.0|0.82|1.39|||Chi-squared||Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.39|0.82|0.6789
71874822|NCT02876835|143267829|SUPERIORITY||Hazard Ratio (HR)|1.37||||0.9016|TWO_SIDED|95.0|0.85|2.19|||Chi-squared||Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||2.19|0.85|0.9016
71874823|NCT02876835|143267829|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8862|TWO_SIDED|95.0|0.95|1.24|||Chi-squared||First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.24|0.95|0.8862
71683949|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal negativity scores||||>0.05
71874824|NCT02876835|143267829|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.8989|TWO_SIDED|95.0|0.92|1.46|||Chi-squared||Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.|||1.46|0.92|0.8989
71874825|NCT02876835|143267830|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.7673|TWO_SIDED|95.0|0.88|1.33|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.33|0.88|0.7673
71874826|NCT02876835|143267831|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.8601|TWO_SIDED|95.0|0.96|1.15|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.15|0.96|0.8601
71874827|NCT02876835|143267832|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.6207|TWO_SIDED|95.0|0.86|1.22|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.22|0.86|0.6207
71874828|NCT02876835|143267833|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.9393|TWO_SIDED|95.0|0.97|1.26|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.26|0.97|0.9393
71874829|NCT02876835|143267834|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.9412|TWO_SIDED|95.0|0.95|1.56|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.56|0.95|0.9412
71874830|NCT02876835|143267835|SUPERIORITY||Hazard Ratio (HR)|1.27||||0.8994|TWO_SIDED|95.0|0.88|1.84|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.|||1.84|0.88|0.8994
71874831|NCT02876835|143267836|SUPERIORITY||Subdistribution hazard ratio|0.92||||0.2073|TWO_SIDED|95.0|0.75|1.13|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.13|0.75|0.2073
71874832|NCT02876835|143267837|SUPERIORITY||Subdistribution hazard ratio|1.0||||0.5068|TWO_SIDED|95.0|0.84|1.19|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.19|0.84|0.5068
71874833|NCT02876835|143267838|SUPERIORITY||Subdistribution hazard ratio|0.88||||0.3285|TWO_SIDED|95.0|0.51|1.54|||Wald test||Subdistribution hazard ratio was estimated using Fine \& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.|||1.54|0.51|0.3285
71874834|NCT02876835|143267839|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was greater than the pre-specified non-inferiority margin of -0.75 g/dL.|LS mean difference|0.03|||||TWO_SIDED|95.0|-0.05|0.11||||||||0.11|-0.05|
71874835|NCT02876835|143267840|SUPERIORITY||Difference in response rate|8.3|||<|0.0001|TWO_SIDED|95.0|5.2|11.4|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test adjusted for current ESA use and region was used to compare the number of responders between the treatment groups.|||11.4|5.2|<0.0001
71874836|NCT02876835|143267841|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Mean Difference (Final Values)|4.57|||||TWO_SIDED|95.0|2.04|7.11|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||7.11|2.04|
71874837|NCT02876835|143267842|SUPERIORITY||Probability|0.55|||<|0.0001|TWO_SIDED|95.0|0.53|0.57|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.57|0.53|<0.0001
71874838|NCT02876835|143267843|NON_INFERIORITY|Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.|Median Difference (Final Values)|3.94|||||TWO_SIDED|95.0|1.9|5.91|||||Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.|||5.91|1.90|
71874839|NCT02876835|143267844|SUPERIORITY||Probability|0.54|||<|0.0001|TWO_SIDED|95.0|0.52|0.56|||van Elteren test||Mann-Whitney estimate (Probability) of the treatment effect has been presented.|||0.56|0.52|<0.0001
71874840|NCT02876835|143267845|SUPERIORITY||LS mean difference|0.56||||0.7916|TWO_SIDED|95.0|-0.79|1.9|||MMRM||The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.90|-0.79|0.7916
71916266|NCT02148952|143353921|SUPERIORITY||Risk Ratio (RR)|317.0|||<|0.001|TWO_SIDED|95.0|50.4|1989.0|||Chi-squared, Corrected|||Newborn temperature taken||1989|50.4|<0.001
71916267|NCT02148952|143353921|SUPERIORITY||Risk Ratio (RR)|7.3|||<|0.001|TWO_SIDED|95.0|2.4|22.0|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||22.0|2.4|<0.001
71916268|NCT02148952|143353921|SUPERIORITY||Risk Ratio (RR)|38.7|||<|0.001|TWO_SIDED|95.0|7.7|194.0|||Chi-squared, Corrected|||Skin-to-skin care maintained for 1 hr||194|7.7|<0.001
71916269|NCT02148952|143353921|SUPERIORITY||Risk Ratio (RR)|19.4|||<|0.001|TWO_SIDED|95.0|11.4|33.2|||Chi-squared, Corrected|||Initiation of breast-feeding||33.2|11.4|<0.001
71916270|NCT02148952|143353921|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
71874841|NCT02876835|143267845|SUPERIORITY||LS mean difference|0.65||||0.9581|TWO_SIDED|95.0|-0.09|1.38|||MMRM||The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.38|-0.09|0.9581
71874842|NCT02876835|143267845|SUPERIORITY||LS mean difference|0.6||||0.9241|TWO_SIDED|95.0|-0.22|1.43|||MMRM||The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.|||1.43|-0.22|0.9241
71874843|NCT02876835|143267846|SUPERIORITY||LS mean difference|-0.08||||0.442|TWO_SIDED|95.0|-1.18|1.02|||ANCOVA||For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||1.02|-1.18|0.4420
71874844|NCT02876835|143267846|SUPERIORITY||LS mean difference|0.11||||0.6369|TWO_SIDED|95.0|-0.52|0.75|||ANCOVA||For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.75|-0.52|0.6369
71874845|NCT02876835|143267846|SUPERIORITY||LS mean difference|0.04||||0.549|TWO_SIDED|95.0|-0.65|0.74|||ANCOVA||For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.|||0.74|-0.65|0.5490
71874846|NCT02876835|143267847|SUPERIORITY||Ratio of exacerbation rate|0.88||||0.0074|TWO_SIDED|95.0|0.79|0.98|||Negative binomial model||Ratio of model estimated exacerbation rates and CIs estimated using negative binomial model with treatment,current ESA use at randomization and region as covariates and logarithm of time on treatment as offset variable for treatment group comparison.|||0.98|0.79|0.0074
71874847|NCT02876835|143267849|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0113|TWO_SIDED|95.0|0.42|0.94|||Wald test||Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, current ESA use and region.|||0.94|0.42|0.0113
71874848|NCT02876835|143267850|SUPERIORITY||LS mean difference|-0.36||||0.932|TWO_SIDED|95.0|-0.83|0.11|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time,current ESA use at randomization, region,Baseline value and Baseline value by time and treatment by time interactions|||0.11|-0.83|0.9320
71874849|NCT02876835|143267850|SUPERIORITY||LS mean difference|-0.11||||0.6761|TWO_SIDED|95.0|-0.59|0.36|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.36|-0.59|0.6761
71874850|NCT02876835|143267850|SUPERIORITY||LS mean difference|0.12||||0.3335|TWO_SIDED|95.0|-0.43|0.67|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.67|-0.43|0.3335
71874851|NCT02876835|143267850|SUPERIORITY||LS mean difference|-0.2||||0.7423|TWO_SIDED|95.0|-0.81|0.41|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.41|-0.81|0.7423
71874852|NCT02876835|143267851|SUPERIORITY||LS mean difference|-0.29||||0.8268|TWO_SIDED|95.0|-0.9|0.32|||MMRM||Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions.|||0.32|-0.90|0.8268
71874853|NCT02876835|143267851|SUPERIORITY||LS mean difference|-0.15||||0.6851|TWO_SIDED|95.0|-0.77|0.47|||MMRM||Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.47|-0.77|0.6851
71874854|NCT02876835|143267851|SUPERIORITY||LS mean difference|-0.33||||0.8316|TWO_SIDED|95.0|-1.01|0.35|||MMRM||Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.35|-1.01|0.8316
71874855|NCT02876835|143267851|SUPERIORITY||LS mean difference|-0.35||||0.8032|TWO_SIDED|95.0|-1.16|0.46|||MMRM||Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \& treatment by time interactions|||0.46|-1.16|0.8032
71874856|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.34||||0.8562|TWO_SIDED|95.0|-0.95|0.28|||MMRM||B pain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.28|-0.95|0.8562
71874857|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.15||||0.6849|TWO_SIDED|95.0|-0.77|0.47|||MMRM||B pain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.47|-0.77|0.6849
71874858|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.49||||0.9074|TWO_SIDED|95.0|-1.22|0.24|||MMRM||B pain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.24|-1.22|0.9074
71874859|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.47||||0.8765|TWO_SIDED|95.0|-1.26|0.32|||MMRM||B pain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.32|-1.26|0.8765
71874860|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.08||||0.6252|TWO_SIDED|95.0|-0.56|0.4|||MMRM||GH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.40|-0.56|0.6252
71916271|NCT02148952|143353922|SUPERIORITY||Risk Ratio (RR)|182.0|||<|0.001|TWO_SIDED|95.0|33.5|993.0|||Chi-squared, Corrected|||Maternal temperature taken||993|33.5|<0.001
71683950|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal negativity scores||||>0.05
71874861|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.2||||0.7852|TWO_SIDED|95.0|-0.68|0.29|||MMRM||GH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.29|-0.68|0.7852
71874862|NCT02876835|143267852|SUPERIORITY||LS mean difference|0.1||||0.3614|TWO_SIDED|95.0|-0.46|0.66|||MMRM||GH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.66|-0.46|0.3614
71874863|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.08||||0.5991|TWO_SIDED|95.0|-0.7|0.54|||MMRM||GH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.54|-0.70|0.5991
71874864|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.31||||0.8526|TWO_SIDED|95.0|-0.88|0.27|||MMRM||MH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.27|-0.88|0.8526
71874865|NCT02876835|143267852|SUPERIORITY||LS mean difference|0.02||||0.4673|TWO_SIDED|95.0|-0.56|0.61|||MMRM||MH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.61|-0.56|0.4673
71874866|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.31||||0.8262|TWO_SIDED|95.0|-0.95|0.33|||MMRM||MH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.33|-0.95|0.8262
71874867|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.25||||0.738|TWO_SIDED|95.0|-1.0|0.51|||MMRM||MH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.51|-1.00|0.7380
71874868|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.09||||0.5997|TWO_SIDED|95.0|-0.8|0.62|||MMRM||RE,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.62|-0.80|0.5997
71916272|NCT02148952|143353922|SUPERIORITY||Risk Ratio (RR)|9.9|||<|0.001|TWO_SIDED|95.0|3.8|25.8|||Chi-squared, Corrected|||Maternal blood pressure taken||25.8|3.8|<0.001
71916273|NCT02148952|143353922|SUPERIORITY||Risk Ratio (RR)|0.4||||0.3|TWO_SIDED|95.0|0.1|2.1|||Chi-squared, Corrected|||Mother given magnesium sulfate||2.1|0.1|0.30
71916274|NCT02148952|143353923|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected|||||||<0.001
71916275|NCT02148952|143353924|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|1.00
71916276|NCT02148952|143353924|SUPERIORITY||Risk Ratio (RR)|19.1|||<|0.001|TWO_SIDED|95.0|7.9|46.5|||Chi-squared, Corrected|||Maternal blood pressure taken||46.5|7.9|<0.001
71916277|NCT02148952|143353924|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated due to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
71916278|NCT02148952|143353924|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Partography started||||<0.001
71916279|NCT02148952|143353924|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
71916280|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|19.9|||<|0.001|TWO_SIDED|95.0|6.6|60.4|||Chi-squared, Corrected|||Hand hygiene||60.4|6.6|<0.001
71916281|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|2.1||||0.04|TWO_SIDED|95.0|1.0|4.1|||Chi-squared, Corrected|||No oxytocin given before delivery||4.1|1.0|0.04
71916282|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|2.4||||0.006|TWO_SIDED|95.0|1.3|4.3|||Chi-squared, Corrected|||Clean towel available||4.3|1.3|0.006
71916283|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|1.0||||0.34|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Clean scissors or blade available||1.1|1.0|0.34
71916284|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|1.0||||0.25|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available||1.0|1.0|0.25
71916285|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.1|||Chi-squared, Corrected|||Mucus extractor available||1.1|1.0|0.50
71916286|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|1.0||||0.32|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Neonatal bag and mask available||1.0|1.0|0.32
71916287|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|1.4||||0.11|TWO_SIDED|95.0|0.9|2.1|||Chi-squared, Corrected|||Pads available||2.1|0.9|0.11
71916288|NCT02148952|143353925|SUPERIORITY||Risk Ratio (RR)|37.9|||<|0.001|TWO_SIDED|95.0|7.3|196.0|||Chi-squared, Corrected|||Checklist available||196|7.3|<0.001
71916289|NCT02148952|143353926|SUPERIORITY||Risk Ratio (RR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.5|||Chi-squared, Corrected|||Oxytocin administered||7.5|1.8|<0.001
71916290|NCT02148952|143353926|SUPERIORITY||Risk Ratio (RR)|0.6||||0.19|TWO_SIDED|95.0|0.3|1.3|||Chi-squared, Corrected|||Neonatal bag used||1.3|0.3|0.19
71916291|NCT02148952|143353926|SUPERIORITY||Risk Ratio (RR)|1.0||||0.5|TWO_SIDED|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present||1.0|1.0|0.50
71916292|NCT02148952|143353927|SUPERIORITY||Risk Ratio (RR)|1.1||||0.08|TWO_SIDED|95.0|1.0|1.3|||Chi-squared, Corrected|||Newborn weight taken||1.3|1.0|0.08
71916293|NCT02148952|143353927|SUPERIORITY||Risk Ratio (RR)|91.5|||<|0.001|TWO_SIDED|95.0|11.0|758.0|||Chi-squared, Corrected|||Newborn temperature taken||758|11.0|<0.001
71916294|NCT02148952|143353927|SUPERIORITY||Risk Ratio (RR)|8.2|||<|0.001|TWO_SIDED|95.0|2.5|27.5|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth||27.5|2.5|<0.001
71916295|NCT02148952|143353927|SUPERIORITY||Other|0.0||||0.01|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Skin-to-skin care maintained for 1 hr||||0.01
71916296|NCT02148952|143353927|SUPERIORITY||Risk Ratio (RR)|7.9|||<|0.001|TWO_SIDED|95.0|3.7|16.7|||Chi-squared, Corrected|||Initiation of breast-feeding||16.7|3.7|<0.001
71916297|NCT02148952|143353927|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use||||<0.001
71916298|NCT02148952|143353928|SUPERIORITY||Other|0.0|||<|0.001|TWO_SIDED||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Maternal temperature taken||||<0.001
71916299|NCT02148952|143353928|SUPERIORITY||Risk Ratio (RR)|12.7|||<|0.001|TWO_SIDED|95.0|4.7|34.3|||Chi-squared, Corrected|||Maternal blood pressure taken||34.3|4.7|<0.001
71916300|NCT02148952|143353928|SUPERIORITY||Risk Ratio (RR)|1.1||||0.95|TWO_SIDED|95.0|0.2|6.6|||Chi-squared, Corrected|||Mother given magnesium sulfate||6.6|0.2|0.95
71916301|NCT02203916|143353944|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.317|STANDARD_ERROR_OF_MEAN|2.4502|<|0.001|TWO_SIDED|95.0|-18.138|-8.497||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-8.497|-18.138|<0.001
71916302|NCT02203916|143353944|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.955|STANDARD_ERROR_OF_MEAN|2.447|<|0.001|TWO_SIDED|95.0|-19.77|-10.141||"Overall type 1 error rate of 0.05 was controlled using principle of 'closed' testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis all treatment groups equal was first rejected at 0.05."|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.||||-10.141|-19.770|<0.001
71916303|NCT00414973|143353964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.39|STANDARD_ERROR_OF_MEAN|0.76|<|0.0001||95.0|2.89|5.89||There were no adjustments for multiple comparisons.|ANCOVA||Difference = Teriparatide minus Calcitonin|Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.||5.89|2.89|<0.0001
71916304|NCT00414973|143353965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.7||0.9062||95.0|-1.3|1.46|||ANCOVA||Difference = Teriparatide minus Calcitonin|||1.46|-1.30|0.9062
71916305|NCT00414973|143353966|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
71916306|NCT00414973|143353966|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value for Week 24 Percentage Change.|Wilcoxon Rank-Sum Test|||||||<0.0001
71916307|NCT00414973|143353967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.63|STANDARD_ERROR_OF_MEAN|2.2||0.2409||95.0|-1.87|7.13|||ANCOVA||Difference = Teriparatide minus Calcitonin|||7.13|-1.87|0.2409
71916308|NCT00414973|143353968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.96|STANDARD_ERROR_OF_MEAN|1.9||0.6156||95.0|-4.85|2.92|||ANCOVA||Difference = Teriparatide minus Calcitonin|||2.92|-4.85|0.6156
71916309|NCT00414973|143353969|SUPERIORITY_OR_OTHER|||||||0.0026||95.0||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0026
71916310|NCT00414973|143353969|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||P-value for 24 Week Percentage Change.|Wilcoxon Rank-Sum Test|||||||0.0006
71916311|NCT03236506|143353970|NON_INFERIORITY|Assuming a 95% SVR rate (based on published studies) in the DOT arm of the trial in this population and a non-inferiority limit of 14% (which would be likely to maintain cost-effectiveness) then at a 5% significance level and 90% power we would need a sample size of 42 in each group 126 in total. To allow for drop-outs we will aim to recruit 135 individuals, 45 per group.|Odds Ratio (OR)|0.64||||0.67|TWO_SIDED|95.0|0.14|3.0|||Logistic|||||3.00|0.14|0.67
71916312|NCT03236506|143353970|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|0.53||||0.41|TWO_SIDED|95.0|0.11|2.45|||logistic|||||2.45|0.11|0.41
71916313|NCT03236506|143353970|NON_INFERIORITY|Described in Statistical Analysis 1.|Odds Ratio (OR)|1.22||||0.82|TWO_SIDED|95.0|0.23|6.61|||logistic|||||6.61|0.23|0.82
71916314|NCT03152110|143354000|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||||||.203
71916315|NCT03152110|143354001|SUPERIORITY|||||||0.931|||||||t-test, 2 sided|||||||0.931
71916316|NCT00085644|143354025|SUPERIORITY_OR_OTHER||Risk Difference (RD)|37.6|||<|0.001||95.0|27.4|47.8|||Chi-squared||Risk difference is measured as a percentage.|ASAS 20 response rates of the adalimumab group were compared with the placebo group using Pearson's Chi-square test. The counts and percentages were calculated for total sample and by therapy group. Statistical tests were 2-sided. For the statistical analysis, subjects with missing data before Week 12 were considered as nonresponders. The comparisons were performed at an alpha level = 0.05.||47.8|27.4|< 0.001
71916317|NCT00085644|143354026|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.985||95.0|||||ANCOVA|||||||0.985
71683951|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in negativity scores||||>0.05
71874869|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.26||||0.7649|TWO_SIDED|95.0|-0.98|0.45|||MMRM||RE,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.45|-0.98|0.7649
71874870|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.37||||0.8175|TWO_SIDED|95.0|-1.18|0.43|||MMRM||RE,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.18|0.8175
71874871|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.52||||0.8591|TWO_SIDED|95.0|-1.47|0.43|||MMRM||RE,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.43|-1.47|0.8591
71874872|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.5||||0.9588|TWO_SIDED|95.0|-1.06|0.06|||MMRM||RP,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.06|-1.06|0.9588
71874873|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.33||||0.8761|TWO_SIDED|95.0|-0.9|0.23|||MMRM||RP,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.23|-0.90|0.8761
71874874|NCT02876835|143267852|SUPERIORITY||LS mean difference|0.06||||0.4293|TWO_SIDED|95.0|-0.58|0.7|||MMRM||RP,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.70|-0.58|0.4293
71874875|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.19||||0.6983|TWO_SIDED|95.0|-0.92|0.53|||MMRM||RP,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.53|-0.92|0.6983
71874876|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.62||||0.9743|TWO_SIDED|95.0|-1.25|0.0|||MMRM||SF,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.00|-1.25|0.9743
71874877|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.32||||0.8405|TWO_SIDED|95.0|-0.94|0.31|||MMRM||SF,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.31|-0.94|0.8405
71874878|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.13||||0.6459|TWO_SIDED|95.0|-0.82|0.56|||MMRM||SF,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.56|-0.82|0.6459
71916318|NCT01836029|143354074|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.99||||0.266|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.266
71916319|NCT01836029|143354076|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.399|ONE_SIDED|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank|||||1.22||0.399
71916320|NCT01836029|143354077|SUPERIORITY_OR_OTHER_LEGACY|||||||0.536||||||p-values are from Cochran-Mantel-Haenszel tests controlling for randomization stratification factors and comparing tumor response rates between the treatment groups.|Cochran-Mantel-Haenszel|||||||0.536
71916321|NCT01388491|143354119|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-11.8||||0.5892|TWO_SIDED|95.0|-54.75|31.17||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.17|-54.75|0.5892
71916322|NCT01388491|143354120|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.0||||0.839|TWO_SIDED|95.0|-25.96|31.94||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||31.94|-25.96|0.839
71916323|NCT01388491|143354121|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.8||||0.0021|TWO_SIDED|95.0|-7.87|-1.77||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||-1.77|-7.87|0.0021
71916324|NCT01388491|143354122|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|3.2||||0.2312|TWO_SIDED|95.0|-2.08|8.58||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||8.58|-2.08|0.2312
71874879|NCT02876835|143267852|SUPERIORITY||LS mean difference|-0.38||||0.8272|TWO_SIDED|95.0|-1.17|0.41|||MMRM||SF,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions|||0.41|-1.17|0.8272
71874880|NCT02876835|143267853|SUPERIORITY||LS mean difference|-0.56||||0.9786|TWO_SIDED|95.0|-1.09|-0.02|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||-0.02|-1.09|0.9786
71874881|NCT02876835|143267853|SUPERIORITY||LS mean difference|-0.12||||0.6642|TWO_SIDED|95.0|-0.68|0.44|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.44|-0.68|0.6642
71874882|NCT02876835|143267853|SUPERIORITY||LS mean difference|-0.1||||0.6261|TWO_SIDED|95.0|-0.72|0.52|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.52|-0.72|0.6261
71874883|NCT02876835|143267853|SUPERIORITY||LS mean difference|-0.49||||0.9161|TWO_SIDED|95.0|-1.19|0.21|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.21|-1.19|0.9161
71916325|NCT01388491|143354123|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.6||||0.344|TWO_SIDED|95.0|-1.7|4.85||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||4.85|-1.70|0.3440
71916326|NCT01388491|143354124|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.3||||0.2522|TWO_SIDED|95.0|-0.24|0.92||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.92|-0.24|0.2522
71916327|NCT01388491|143354125|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.9||||0.0143|TWO_SIDED|95.0|0.58|5.13||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.13|0.58|0.0143
71916328|NCT01388491|143354126|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.5||||0.8507|TWO_SIDED|95.0|-4.87|5.91||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||5.91|-4.87|0.8507
71916329|NCT01388491|143354127|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0459|TWO_SIDED|95.0|0.0|0.14||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.14|0.00|0.0459
71916330|NCT01388491|143354128|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1||||0.0318|TWO_SIDED|95.0|0.01|0.26||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.26|0.01|0.0318
71916331|NCT01388491|143354129|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|361.6||||0.1148|TWO_SIDED|95.0|-88.45|811.61||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||811.61|-88.45|0.1148
71916332|NCT01388491|143354130|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.2||||0.7136|TWO_SIDED|95.0|-35.92|52.39||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||52.39|-35.92|0.7136
71916333|NCT01388491|143354131|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1||||0.3903|TWO_SIDED|95.0|-0.29|0.11||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||0.11|-0.29|0.3903
71916334|NCT01388491|143354132|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|14.3||||0.1731|TWO_SIDED|95.0|-6.29|34.8||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II||||34.80|-6.29|0.1731
71916335|NCT03782376|143354164|SUPERIORITY||Difference in percentage|11.5||||0.089|TWO_SIDED|95.0|-1.5|24.5||Threshold for significance was 0.05 level.|Cochran-Mantel Haenszel-chi-square test|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||24.5|-1.5|0.089
71916336|NCT03782376|143354165|SUPERIORITY||Difference in percentage|5.9||||0.338|TWO_SIDED|95.0|-6.0|17.8|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||17.8|-6.0|0.338
71683952|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on negativity scores||||>0.05
71874884|NCT02876835|143267854|SUPERIORITY||LS mean difference|-0.32||||0.8703|TWO_SIDED|95.0|-0.88|0.24|||MMRM||Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.24|-0.88|0.8703
71874885|NCT02876835|143267854|SUPERIORITY||LS mean difference|0.13||||0.3167|TWO_SIDED|95.0|-0.41|0.67|||MMRM||Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.67|-0.41|0.3167
71874886|NCT02876835|143267854|SUPERIORITY||LS mean difference|0.15||||0.3155|TWO_SIDED|95.0|-0.47|0.78|||MMRM||Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.78|-0.47|0.3155
71874887|NCT02876835|143267854|SUPERIORITY||LS mean difference|-0.32||||0.8069|TWO_SIDED|95.0|-1.06|0.41|||MMRM||Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \& treatment by time interactions.|||0.41|-1.06|0.8069
71874888|NCT02876835|143267855|SUPERIORITY||LS mean difference|-0.0234||||0.9724|TWO_SIDED|95.0|-0.0474|0.0005|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.0005|-0.0474|0.9724
71874889|NCT02876835|143267856|SUPERIORITY||LS mean difference|0.7||||0.2687|TWO_SIDED|95.0|-1.5|2.9|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||2.9|-1.5|0.2687
71874890|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.22||||0.978|TWO_SIDED|95.0|-2.4|-0.03|||MMRM||Tired/LE/Weak domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.40|0.9780
71874891|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.97||||0.943|TWO_SIDED|95.0|-2.18|0.23|||MMRM||Tired/LE/Weak domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.23|-2.18|0.9430
71916337|NCT03782376|143354166|SUPERIORITY||Difference in percentage|7.1||||0.3|TWO_SIDED|95.0|-6.0|20.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||20.2|-6.0|0.300
71916338|NCT03782376|143354167|SUPERIORITY||Difference in percentage|6.4||||0.314|TWO_SIDED|95.0|-5.8|18.6|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||18.6|-5.8|0.314
71916339|NCT03782376|143354168|SUPERIORITY||Difference in percentage|18.5||||0.004|TWO_SIDED|95.0|6.8|30.2|||CMH chi-square test (2-sided)|||The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).||30.2|6.8|0.004
71916340|NCT05241470|143354278|SUPERIORITY||Mean Difference (Net)|0.01||||0.9575|TWO_SIDED||||||ANCOVA|||||||0.9575
71916341|NCT05241470|143354278|SUPERIORITY||Mean Difference (Net)|0.01||||0.9741|TWO_SIDED||||||ANCOVA|||||||0.9741
71916342|NCT05241470|143354279|SUPERIORITY|||||||0.5696|||||||ANCOVA|||||||0.5696
71916343|NCT05241470|143354280|SUPERIORITY|||||||0.0266|||||||Fisher Exact|||||||0.0266
71916344|NCT05241470|143354281|SUPERIORITY|||||||0.0055|||||||ANCOVA|||||||0.0055
71916345|NCT05241470|143354282|SUPERIORITY|||||||0.0097|||||||ANCOVA|||||||0.0097
71916346|NCT05241470|143354283|SUPERIORITY|||||||0.0137|||||||ANCOVA|||||||0.0137
71916347|NCT05241470|143354284|SUPERIORITY|||||||0.0332|||||||ANCOVA|||||||0.0332
71916348|NCT05241470|143354285|SUPERIORITY|||||||0.0394|||||||t-test, 2 sided|||||||0.0394
71916349|NCT05241470|143354286|SUPERIORITY|||||||0.0121|||||||Wilcoxon (Mann-Whitney)|||||||0.0121
71916350|NCT05241470|143354287|SUPERIORITY|||||||0.0224|||||||Wilcoxon (Mann-Whitney)|||||||0.0224
71916351|NCT04960202|143354290|SUPERIORITY||Percentage difference|-6.137|STANDARD_ERROR_OF_MEAN|1.057|<|0.0001|TWO_SIDED|95.0|-8.208|-4.066|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-4.066|-8.208|<0.0001
71916352|NCT04960202|143354293|SUPERIORITY||Percentage difference|-5.638|STANDARD_ERROR_OF_MEAN|0.852|<|0.0001|TWO_SIDED|95.0|-7.308|-3.967|||Normal approximation|||The difference of the percentage in the 2 treatment groups and its 95% confidence interval, and p-value based on Normal approximation of the data are presented.||-3.967|-7.308|<0.0001
71916353|NCT04960202|143354294|SUPERIORITY||Hazard Ratio (HR)|1.294||||0.0003|TWO_SIDED|95.0|1.136|1.476|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox proportional hazard (PH) model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 logarithm to base 10 \[log10\] copies/milliliter \[mL\], \>=4 log10 copies/mL) as covariates.||1.476|1.136|0.0003
71683953|NCT03646305|142886283|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on negativity scores||||>0.05
71683954|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at p\< .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of discomfort were equivalent across time.||||<0.001
71683955|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from baseline to post-intervention. Null hypothesis: there would have no significant differences in discomfort levels from baseline to post-intervention across samples||||<0.001
71683956|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in levels of discomfort from post-intervention to follow-up. Null hypothesis: there would be no significant differences in discomfort levels from post-intervention to follow-up across samples||||<0.001
71683957|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of discomfort||||>0.05
71874892|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.6||||0.8042|TWO_SIDED|95.0|-1.98|0.77|||MMRM||Tired/LE/Weak domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.77|-1.98|0.8042
71874893|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.57||||0.977|TWO_SIDED|95.0|-3.11|-0.03|||MMRM||Tired/LE/Weak domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-3.11|0.9770
71874894|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.2||||0.9905|TWO_SIDED|95.0|-2.2|-0.2|||MMRM||CP/SOB,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.20|-2.20|0.9905
71874895|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.65||||0.8939|TWO_SIDED|95.0|-1.67|0.37|||LS mean difference||CP/SOB,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.37|-1.67|0.8939
71683958|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of discomfort||||>0.05
71683959|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of discomfort||||>0.05
71683960|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of discomfort across time||||>0.05
71683961|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of discomfort||||>0.05
71874896|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.52||||0.807|TWO_SIDED|95.0|-1.7|0.66|||MMRM||CP/SOB,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.66|-1.70|0.8070
71874897|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.18||||0.9615|TWO_SIDED|95.0|-2.49|0.13|||MMRM||CP/SOB,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.13|-2.49|0.9615
71874898|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.76||||0.9015|TWO_SIDED|95.0|-1.91|0.39|||MMRM||Cog domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.39|-1.91|0.9015
71874899|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.18||||0.9781|TWO_SIDED|95.0|-2.32|-0.03|||MMRM||Cog domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.03|-2.32|0.9781
71874900|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.77||||0.8778|TWO_SIDED|95.0|-2.07|0.53|||MMRM||Cog domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.53|-2.07|0.8778
71874901|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.65||||0.9864|TWO_SIDED|95.0|-3.11|-0.19|||MMRM||Cog domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.19|-3.11|0.9864
71874902|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.1||||0.9725|TWO_SIDED|95.0|-2.3|0.0|||MMRM||SOB, no activity,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.3|0.9725
71874903|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.3||||0.7188|TWO_SIDED|95.0|-1.5|0.8|||MMRM||SOB, no activity,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.8|-1.5|0.7188
71874904|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.9||||0.8903|TWO_SIDED|95.0|-2.3|0.5|||MMRM||SOB, no activity,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.5|-2.3|0.8903
71874905|NCT02876835|143267857|SUPERIORITY||LS mean difference|0.0||||0.5011|TWO_SIDED|95.0|-1.6|1.6|||MMRM||SOB, no activity,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.6|-1.6|0.5011
71683962|NCT03646305|142886284|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no significant difference between 4 conditions on discomfort levels||||>0.05
71683963|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, willingness to engage with target thought were equivalent across time||||<0.001
71683964|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from baseline to post-intervention. Null hypothesis: there would be no difference in willingness scores from baseline to post-intervention||||<0.001
71683965|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||=|0.053|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in willingness to engage with target thought from post-intervention to follow-up. Null hypothesis: there would be no significant difference in willingness scores from post-intervention to follow-up.||||=0.053
71683966|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal willingness scores||||>0.05
71874906|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.1||||0.9716|TWO_SIDED|95.0|-2.2|0.0|||MMRM||S-SB,Resting, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.2|0.9716
71874907|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.3||||0.6908|TWO_SIDED|95.0|-1.4|0.9|||MMRM||S-SB,Resting, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.4|0.6908
71874908|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.5||||0.7462|TWO_SIDED|95.0|-1.8|0.9|||MMRM||S-SB,Resting, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-1.8|0.7462
71874909|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.5||||0.977|TWO_SIDED|95.0|-2.9|0.0|||MMRM||S-SB,Resting, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.0|-2.9|0.9770
71874910|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.4||||0.9471|TWO_SIDED|95.0|-3.2|0.3|||MMRM||Diff std for LT, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.3|-3.2|0.9471
71874911|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.9||||0.833|TWO_SIDED|95.0|-2.6|0.9|||MMRM||Diff std for LT, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.9|-2.6|0.8330
71683967|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal willingness to engage with the target thought||||>0.05
71683968|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in willingness to engage||||>0.05
71683969|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in willingness to engage with the target thought across time.||||>0.05
71683970|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on willingness to engage||||>0.05
71874912|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.2||||0.8918|TWO_SIDED|95.0|-3.2|0.7|||MMRM||Diff std for LT, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.7|-3.2|0.8918
71874913|NCT02876835|143267857|SUPERIORITY||LS mean difference|-3.2||||0.9986|TWO_SIDED|95.0|-5.4|-1.1|||MMRM||Diff std for LT, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-1.1|-5.4|0.9986
71916354|NCT04960202|143354295|SUPERIORITY||Hazard Ratio (HR)|1.266|||<|0.0001|TWO_SIDED|95.0|1.134|1.412|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.412|1.134|<0.0001
71916355|NCT04960202|143354296|SUPERIORITY||Hazard Ratio (HR)|1.258|||<|0.0001|TWO_SIDED|95.0|1.131|1.4|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained alleviation is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.400|1.131|<0.0001
71916356|NCT04960202|143354297|SUPERIORITY||Odds Ratio (OR)|0.871||||0.3473|TWO_SIDED|95.0|0.652|1.162|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.162|0.652|0.3473
71874914|NCT02876835|143267857|SUPERIORITY||LS mean difference|0.4||||0.3035|TWO_SIDED|95.0|-1.2|2.1|||MMRM||Diff sleep, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||2.1|-1.2|0.3035
71916357|NCT04960202|143354298|SUPERIORITY||Odds Ratio (OR)|0.936||||0.5762|TWO_SIDED|95.0|0.74|1.182|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.182|0.740|0.5762
71916358|NCT04960202|143354299|SUPERIORITY||Odds Ratio (OR)|0.969||||0.7807|TWO_SIDED|95.0|0.773|1.213|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No),baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.213|0.773|0.7807
71683971|NCT03646305|142886285|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on willingness to engage||||>0.05
71874915|NCT02876835|143267857|SUPERIORITY||LS mean difference|-1.4||||0.9563|TWO_SIDED|95.0|-3.1|0.2|||MMRM||Diff sleep, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||0.2|-3.1|0.9563
71916359|NCT04960202|143354300|SUPERIORITY||Hazard Ratio (HR)|1.219||||0.0053|TWO_SIDED|95.0|1.061|1.401|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.401|1.061|0.0053
71874916|NCT02876835|143267857|SUPERIORITY||LS mean difference|-0.4||||0.6548|TWO_SIDED|95.0|-2.3|1.5|||MMRM||Diff sleep, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||1.5|-2.3|0.6548
71874917|NCT02876835|143267857|SUPERIORITY||LS mean difference|-2.4||||0.9832|TWO_SIDED|95.0|-4.5|-0.2|||MMRM||Diff sleep, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.|||-0.2|-4.5|0.9832
71874918|NCT02876835|143267858|SUPERIORITY||LS mean difference|0.02||||0.6917|TWO_SIDED|95.0|-0.05|0.08|||MMRM||Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week 8 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.08|-0.05|0.6917
71874919|NCT02876835|143267858|SUPERIORITY||LS mean difference|0.05||||0.951|TWO_SIDED|95.0|-0.01|0.11|||MMRM||Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week 12 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.11|-0.01|0.9510
71874920|NCT02876835|143267858|SUPERIORITY||LS mean difference|-0.04||||0.1136|TWO_SIDED|95.0|-0.11|0.03|||MMRM||Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week 28 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.03|-0.11|0.1136
71874921|NCT02876835|143267858|SUPERIORITY||LS mean difference|0.05||||0.8859|TWO_SIDED|95.0|-0.03|0.13|||MMRM||Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week 52 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.13|-0.03|0.8859
71874922|NCT02876835|143267859|SUPERIORITY||LS mean difference|-0.2||||0.7716|TWO_SIDED|95.0|-0.74|0.33|||MMRM||MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use at randomization, region, Baseline value and Baseline value by time and treatment by time interactions.|||0.33|-0.74|0.7716
71874923|NCT02979925|143267867|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||||||0.246
71874924|NCT02979925|143267868|SUPERIORITY|||||||0.651|||||||Mixed Models Analysis|||||||0.651
71874925|NCT02979925|143267869|SUPERIORITY|||||||0.902|||||||Mixed Models Analysis|||||||0.902
71874926|NCT05090995|143267882|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71874927|NCT05090995|143267883|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71916360|NCT04960202|143354301|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.0022|TWO_SIDED|95.0|1.068|1.348|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.348|1.068|0.0022
71874928|NCT05090995|143267884|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71874929|NCT05090995|143267885|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71874930|NCT05090995|143267886|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For baseline consequences||||<.0001
71874931|NCT05090995|143267886|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||For effects with time||||<.0001
71874932|NCT05090995|143267887|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||<.0001
71874933|NCT05090995|143267888|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Effect of baseline sleep scores||||<.0001
71874934|NCT05090995|143267888|OTHER|||||||0.04|||||||Mixed Models Analysis|||For effects with time||||0.04
71874935|NCT05090995|143267889|OTHER|||||||0.02|||||||Mixed Models Analysis|||For interaction between treatment group and time||||0.02
71874936|NCT05090995|143267889|OTHER|||||||0.02|||||||Mixed Models Analysis|||Main effects of sex||||0.02
71874937|NCT05090995|143267889|OTHER|||||||0.0007|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||0.0007
71874938|NCT05090995|143267889|OTHER|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71874939|NCT05090995|143267890|OTHER|||||||0.0001|||||||Mixed Models Analysis|||Main effect of day of the week.||||0.0001
71874940|NCT05090995|143267891|OTHER|||||||0.04|||||||Mixed Models Analysis|||For interaction between treatment condition and time||||0.04
71874941|NCT05090995|143267891|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of sex||||<.0001
71874942|NCT05090995|143267891|OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Main effects of type of day of the week (weekday vs. weekend)||||<0.0001
71874943|NCT05090995|143267891|OTHER|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71874944|NCT03049735|143267896|SUPERIORITY||Treatment difference|54.54|||<|0.0001|TWO_SIDED|95.0|44.3|64.78||P-value was stratified by baseline MBL volume (\< 225 mL or ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix + E2/NETA minus placebo.|The primary efficacy analysis was the comparison of the relugolix + E2/NETA group with the placebo group with respect to responder rate.||64.78|44.3|<0.0001
71874945|NCT03049735|143267897|SUPERIORITY||Treatment difference|46.83|||<|0.0001|TWO_SIDED|95.0|37.31|56.35||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America or Rest of World). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference was relugolix plus E2/NETA minus placebo. 95% confidence interval (CI) for difference is based on the normal approximation.|||56.35|37.31|<0.0001
71874946|NCT03049735|143267898|SUPERIORITY||Treatment difference|-61.1|STANDARD_ERROR_OF_MEAN|6.32|<|0.0001|TWO_SIDED|95.0|-73.5|-48.6||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance. Treatment difference is relugolix plus E2/NETA minus placebo.||||-48.6|-73.5|<0.0001
71874947|NCT03049735|143267899|SUPERIORITY||Treatment difference|28.26|||=|0.0377|TWO_SIDED|95.0|3.68|52.84||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||52.84|3.68|= 0.0377
71874948|NCT03049735|143267900|SUPERIORITY||Treatment difference|33.0|||<|0.0001|TWO_SIDED|95.0|18.36|47.56||P-value is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL). Assessed at a 2-sided α = 0.05 significance level.|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||47.56|18.36|<0.0001
71874949|NCT03049735|143267901|SUPERIORITY||Treatment difference|-12.1|STANDARD_ERROR_OF_MEAN|7.19||0.0921|TWO_SIDED|95.0|-26.3|2.0||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||2|-26.3|0.0921
71874950|NCT03049735|143267902|SUPERIORITY||Treatment difference|-15.1|STANDARD_ERROR_OF_MEAN|3.98||0.0002|TWO_SIDED|95.0|-23.0|-7.3||Based on analysis of covariance model with treatment, randomization stratification factors, Baseline MBL volume, geographic region (North America, Rest of World), and Baseline values as covariate. Assessed at a 2-sided α = 0.05 significance level.|ANCOVA|||||-7.3|-23|0.0002
71874951|NCT03049735|143267903|SUPERIORITY||Treatment difference|-28.9|STANDARD_ERROR_OF_MEAN|3.75|<|0.0001|TWO_SIDED|95.0|-36.3|-21.5||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|Assessed at a 2-sided α = 0.05 significance level. LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||-21.5|-36.3|<0.0001
71874952|NCT03049735|143267906|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71874953|NCT03049735|143267911|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
71874954|NCT03049735|143267912|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71874955|NCT03049735|143267913|SUPERIORITY||||||<|0.0001||||||P-value is based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix plus E2/NETA with placebo.|Log Rank|||||||<0.0001
71874956|NCT03049735|143267914|SUPERIORITY||||||<|0.0001||||||P-value was based on Log-rank test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World) from the proportional hazard regression model comparing relugolix + E2/NETA with placebo.|Log Rank|||||||<0.0001
71874957|NCT03049735|143267915|SUPERIORITY|||||||0.0377||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0377
71874958|NCT03049735|143267916|SUPERIORITY|||||||0.0117||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||0.0117
71874959|NCT03049735|143267917|SUPERIORITY|||||||0.0084||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World). Lower limit of normal is Hgb \< 11.6 g/dL.|Cochran-Mantel-Haenszel|||||||0.0084
71874960|NCT03049735|143267918|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71874961|NCT03049735|143267919|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71874962|NCT03049735|143267920|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71874963|NCT03049735|143267921|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71916361|NCT04960202|143354302|SUPERIORITY||Hazard Ratio (HR)|1.194||||0.0021|TWO_SIDED|95.0|1.066|1.337|||Cox Proportional Hazard Model|||Analysis of treatment effect on time to sustained resolution is based on Cox PH model with treatment and geographic region effects as independent variables, and symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\<4 log10 copies/mL, \>=4 log10 copies/mL) as covariates.||1.337|1.066|0.0021
71916362|NCT04960202|143354309|SUPERIORITY||Odds Ratio (OR)|1.088||||0.5293|TWO_SIDED|95.0|0.836|1.416|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.416|0.836|0.5293
71916363|NCT04960202|143354310|SUPERIORITY||Odds Ratio (OR)|1.053||||0.6379|TWO_SIDED|95.0|0.85|1.303|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.303|0.850|0.6379
71916364|NCT04960202|143354311|SUPERIORITY||Odds Ratio (OR)|1.046||||0.676|TWO_SIDED|95.0|0.848|1.29|||Regression, Logistic|||Odds ratio, 95% CI and p-value were computed from a logistic regression model including main effects of treatment, geographic region, symptom onset duration (\<=3, \>3), COVID-19 mAb treatment (Yes/No), baseline SARS-CoV-2 serology status and baseline viral load (\< 4 log10 copies/mL, \>= 4 log10 copies/mL).||1.290|0.848|0.6760
71916365|NCT04960202|143354312|SUPERIORITY||Odds Ratio (OR)|19.4||||0.1997||95.0|7.788|48.328|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||48.328|7.788|0.1997
71916366|NCT04960202|143354312|OTHER||Odds Ratio (OR)|8.948|||||TWO_SIDED|95.0|4.159|19.253|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||19.253|4.159|
71916367|NCT04960202|143354313|SUPERIORITY||Odds Ratio (OR)|20.875||||0.281|TWO_SIDED|95.0|10.097|43.156|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||43.156|10.097|0.2810
71916368|NCT04960202|143354313|SUPERIORITY||Odds Ratio (OR)|12.452|||||TWO_SIDED|95.0|6.823|22.725|||Breslow Day test||Odds ratio for Day 5 vs Day 1: Placebo|||22.725|6.823|
71916369|NCT04960202|143354314|SUPERIORITY||Odds Ratio (OR)|21.119||||0.2226|TWO_SIDED|95.0|10.412|42.837|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: PF-07321332 300 mg + Ritonavir 100 mg|||42.837|10.412|0.2226
71916370|NCT04960202|143354314|SUPERIORITY||Odds Ratio (OR)|12.036||||0.2342|TWO_SIDED|95.0|6.808|21.28|||Breslow-Day test||Odds ratio for Day 5 vs Day 1: Placebo|||21.280|6.808|0.2342
71922327|NCT00711009|143365109|NON_INFERIORITY_OR_EQUIVALENCE|The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was \>/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.|Diff. in Percentage of Subj. Responding|-1.6||||0.85|TWO_SIDED|95.0|-12.0|8.8|||exact binomial method|||The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of -20% (with a type I error rate of 0.05).||8.8|-12.0|0.850
71916371|NCT03558828|143354344|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates (Cohen's d) for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator.||"The longitudinal trajectories using generalized estimating equations (GEEs) were estimated. Cases for responders are duplicated and weighted based on the inverse probability of being assigned to a particular adaptive intervention (i.e., responders have a ½ probability of assignment to a specific adaptive intervention, and non-responders have a ¼ probability).~Only the Phase 1 (baseline to 8 weeks) treatment condition x time interaction was included because it preceded the randomization to Phase 2 (weeks 9-34) treatment conditions. Planned contrasts were used to test specific hypotheses. Effect size estimates for all analyses were created by using the relevant slope effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests."|||
71916372|NCT03558828|143354345|OTHER|A power analysis based on the study's primary aim (impact of augmented treatments on non-responders) was conducted. An estimated effect size of d=0.41 for the difference between the two augmented treatments was used. With a 2-tailed alpha of 0.05, a pre-post correlation of r=0.60, and a sample size of 188 non-responders, an estimated 80% power was obtained. Assuming 67% non-response to the initial treatments and 10% attrition, the final target sample size was N=312.|Effect size estimates|0.41|||||TWO_SIDED|95.0||||All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|GEEs||Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. An estimated effect size of d=0.41 was used.||There were time slope terms for Phase 1 (baseline to 8-week assessment), Phase 2 (9-weeks to 34-week assessment), and Phase 3 (maintenance from 35-weeks to 50-week assessment). Also, there were interactions of condition and time slopes. For Phase 1, only the Phase 1 treatment condition x time interaction was included because it preceded the randomization to Phase 2 treatment conditions. Supplementary analyses were conducted to compare the trajectories of responders versus non-responders to the Phase 1 treatment. Effect size estimates for all analyses were created by using the relevant slope (i.e., change) effect as the numerator and the baseline standard deviation of the dependent variable as the denominator. The resulting effect size is equivalent to a Cohen's d, representing mean change (or difference in change) in standard deviation units. All analyses employed an intent-to-treat approach using a two-tailed alpha of 0.05 with no adjustment for multiple tests.|||
71916373|NCT03671148|143354371|SUPERIORITY||Response Rate Difference|24.5|||<|0.001|TWO_SIDED|95.0|15.9|33.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|The comparison between the risankizumab and placebo treatment groups for the primary efficacy endpoint (ACR20 at Week 24) was performed using the Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors of current use of csDMARD (0 vs ≥ 1), number of prior biologic therapies (0 vs ≥ 1), and extent of psoriasis (≥ 3% BSA or \< 3% BSA) at Baseline.||33.0|15.9|<0.001
71916374|NCT03671148|143354372|SUPERIORITY||Least Squares (LS) Mean Difference|-0.16|||<|0.001|TWO_SIDED|95.0|-0.26|-0.07||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||-0.07|-0.26|<0.001
71916375|NCT03671148|143354373|SUPERIORITY||Response Rate Difference|44.3|||<|0.001|TWO_SIDED|95.0|33.9|54.6||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.6|33.9|<0.001
71916376|NCT03671148|143354374|SUPERIORITY||Response Rate Difference|22.6|||<|0.001|TWO_SIDED|95.0|13.9|31.2||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||31.2|13.9|<0.001
71916377|NCT03671148|143354375|SUPERIORITY||Response Rate Difference|14.0|||<|0.001|TWO_SIDED|95.0|7.0|21.0||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||21.0|7.0|<0.001
71916378|NCT03671148|143354376|SUPERIORITY||LS Mean Difference|3.86|||<|0.001|TWO_SIDED|95.0|2.41|5.31||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||5.31|2.41|<0.001
71916379|NCT03671148|143354377|SUPERIORITY||LS Mean Difference|2.2||||0.009|TWO_SIDED|95.0|0.6|3.9||A fixed sequence testing procedure is used to control the overall type I error rate at 2-sided alpha = 0.05 for the primary endpoint and ranked secondary endpoints.|Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, and stratification factors as fixed factors and Baseline value as covariate.|Difference = Risankizumab - Placebo|||3.9|0.6|0.009
71874964|NCT03049735|143267922|SUPERIORITY||||||<|0.0001||||||P-value for testing difference between Relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71874965|NCT03049735|143267923|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71916380|NCT03671148|143354378|SUPERIORITY||Response Rate Difference|16.6|||<|0.001|TWO_SIDED|95.0|9.7|23.6|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||23.6|9.7|<0.001
71916381|NCT03671148|143354379|SUPERIORITY||Response Rate Difference|6.0||||0.024|TWO_SIDED|95.0|0.8|11.3|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||11.3|0.8|0.024
71916382|NCT03671148|143354380|SUPERIORITY||Response Rate Difference|13.8||||0.009|TWO_SIDED|95.0|3.5|24.2|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||24.2|3.5|0.009
71916383|NCT03671148|143354381|SUPERIORITY||Response Rate Difference|38.8|||<|0.001|TWO_SIDED|95.0|22.9|54.8|||Cochran-Mantel-Haenszel|CMH test adjusted for the stratification factors of current use of csDMARD, number of prior biologic therapies, and extent of psoriasis at Baseline.|Response Rate Difference = Risankizumab - Placebo|||54.8|22.9|<0.001
71916384|NCT01994109|143354382|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71916385|NCT01994109|143354382|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71916386|NCT01994109|143354383|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71916387|NCT01994109|143354383|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71916388|NCT00435929|143354385|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.656|||||TWO_SIDED|90.0|0.268|1.603||||||Comparison between normal liver function and moderate hepatic impairment for SQV||1.603|0.268|
71916389|NCT00435929|143354385|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.764|||||TWO_SIDED|90.0|0.505|1.156||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.156|0.505|
71916390|NCT00435929|143354386|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.716|||||TWO_SIDED|90.0|0.311|1.644||||||Comparison between normal liver function and moderate hepatic impairment for SQV.||1.644|0.311|
71916391|NCT00435929|143354386|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.844|||||TWO_SIDED|90.0|0.551|1.292||||||Comparison between normal liver function and moderate hepatic impairment for RTV.||1.292|0.551|
71916392|NCT00576147|143354396|SUPERIORITY_OR_OTHER||Percent Sensitivity|88.0|||||TWO_SIDED|95.0|75.0|95.0||||||||95.0|75.0|
71916393|NCT00576147|143354396|SUPERIORITY_OR_OTHER||Percent Specificity|90.7|||||TWO_SIDED|95.0|86.4|93.7||||||||93.7|86.4|
71916394|NCT01933399|143354406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4||||0.01|TWO_SIDED|95.0|2.2|16.6|||ANCOVA||"Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline.~a priori threshold determined to be .05. no adjustments for multiple comparisons."|ANCOVA Adjusted for baseline score||16.6|2.2|.01
71916395|NCT01933399|143354406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3||||0.16|TWO_SIDED|95.0|-2.0|12.6||a priori threshold determined to be .05. no adjustments for multiple comparisons.|ANCOVA|Adjustment for baseline.||||12.6|-2.0|.16
71916396|NCT01933399|143354407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.01|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|||Adjusted for baseline.||-0.4|-2.3|0.01
71916397|NCT01933399|143354407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.05|TWO_SIDED|95.0|-2.1|0.0|||ANCOVA|||Adjusted for baseline.||0|-2.1|.05
71916398|NCT00062647|143354483|NON_INFERIORITY_OR_EQUIVALENCE|No margin was justified owing to the exploratory nature of the investigation.|Risk Difference (RD)|1.0||||||95.0|-35.5|31.9|||the difference in the 2 eradication rate|Statistical testing was limited to interval estimation (95% CI) of the difference in the 2 eradication rates using the method of Agresti and Caffo.||||31.9|-35.5|
71874966|NCT03049735|143267924|SUPERIORITY||||||<|0.0001||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL) and geographic region (North America, Rest of World).|Cochran-Mantel-Haenszel|||||||<0.0001
71916399|NCT05083949|143354496|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.57|STANDARD_DEVIATION|5.23||0.7792|TWO_SIDED|90.0|97.03|102.19|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.19|97.03|0.7792
71916400|NCT05083949|143354497|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.36|STANDARD_DEVIATION|10.18||0.6493|TWO_SIDED|90.0|96.39|106.59|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||106.59|96.39|0.6493
71683972|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.01|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, avoidance of target thought were equivalent across time||||<0.01
71874967|NCT03049735|143267925|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71874968|NCT03049735|143267926|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71874969|NCT03049735|143267928|SUPERIORITY||||||<|0.0001||||||Treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects. The multiple visits for each participant were the repeated measures as random effect within each participant and an unstructured covariance.|Mixed Models Analysis|LS means and p-value for test of difference is relugolix plus E2/NETA minus placebo.||||||<0.0001
71874970|NCT03049735|143267935|SUPERIORITY|||||||0.0002||||||P-value was based on Cochran-Mantel-Haenszel test stratified by Baseline MBL volume (\< 225 mL, ≥ 225 mL).|Cochran-Mantel-Haenszel|||||||0.0002
71874971|NCT03153111|143267940|SUPERIORITY||Geometric mean ratio|1.02||||0.7923|TWO_SIDED|90.0|0.88|1.19|||ANCOVA|||||1.19|0.88|0.7923
71874972|NCT03153111|143267941|SUPERIORITY||Least square mean difference|-3.5|STANDARD_ERROR_OF_MEAN|2.82||0.2172|TWO_SIDED|90.0|-8.17|1.17|||ANCOVA|||||1.17|-8.17|0.2172
71874973|NCT03153111|143267942|SUPERIORITY||Least square mean difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.3665|TWO_SIDED|90.0|-0.05|0.02|||ANCOVA|||||0.02|-0.05|0.3665
71916401|NCT05083949|143354498|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.63|STANDARD_DEVIATION|7.65||0.471|TWO_SIDED|90.0|97.85|105.55|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis of the was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.55|97.85|0.4710
71916402|NCT05083949|143354499|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|98.11|STANDARD_DEVIATION|8.14||0.4251|TWO_SIDED|90.0|94.24|102.15|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.15|94.24|0.4251
71916403|NCT05083949|143354500|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|99.49|STANDARD_DEVIATION|5.25||0.7379|TWO_SIDED|90.0|96.93|102.11|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||102.11|96.93|0.7379
71874974|NCT03891524|143267972|OTHER|||||||0.0004|||||||MCP-mod analysis|||||||0.0004
71874975|NCT03891524|143267973|OTHER|||||||0.7188|||||||MCP-MOD analysis|||||||0.7188
71874976|NCT01389765|143268007|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.01|||||TWO_SIDED|90.0|0.97|1.05|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatment states (fed/fasted), and the 90% confidence interval for the ratio.||||1.05|0.97|
71874977|NCT01389765|143268008|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.96|||||TWO_SIDED|90.0|0.92|1.01|||Mixed Models Analysis|Analyzed was a ratio of geometric LS means between the 2 treatments states (fed/fasted), and the 90% confidence interval for the ratio.||||1.01|0.92|
71874978|NCT01389765|143268009|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.0||||0.0031|TWO_SIDED|90.0|0.5|1.5|||Wilcoxon (Mann-Whitney)|Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.||||1.50|0.50|0.0031
71874979|NCT00174265|143268010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0148||95.0||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.||||0.0148
71874980|NCT00174265|143268011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||95.0||||Significant level adjusted for one interim analysis was set as 0.049 two-sided.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.||||0.8100
71874981|NCT00447382|143268039|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.04||||0.649||95.0|0.86|1.26|||ANOVA|Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data).|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|"Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA."||1.26|0.86|0.649
71874982|NCT00447382|143268041|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.03||||0.758||95.0|-0.21|0.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.15|-0.21|0.758
71874983|NCT00447382|143268042|SUPERIORITY_OR_OTHER_LEGACY||Estimated treatment difference|-0.1||||0.812||95.0|-0.89|0.7|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.||0.7|-0.89|0.812
71874984|NCT00447382|143268044|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|0.93||||0.15||95.0|0.84|1.03|||ANOVA|Adjustments:Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.03|0.84|0.15
71874985|NCT00447382|143268045|SUPERIORITY_OR_OTHER_LEGACY||Treatment Ratio|1.0||||0.966||95.0|0.87|1.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.||1.15|0.87|0.966
71874986|NCT04600336|143268063|SUPERIORITY||Mean Difference (Final Values)|-9.11||||0.0019|TWO_SIDED|90.0|-13.76|-4.46|||t-test, 2 sided|||||-4.46|-13.76|0.0019
71874987|NCT04600336|143268063|SUPERIORITY||Mean Difference (Final Values)|-5.09||||0.0732|TWO_SIDED|90.0|-9.7|-0.48|||t-test, 2 sided|||||-0.48|-9.70|0.0732
71874988|NCT04600336|143268066|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||||||0.0120
71874989|NCT04600336|143268069|SUPERIORITY|||||||0.0057|||||||Kruskal-Wallis|||||||0.0057
71916404|NCT05083949|143354501|EQUIVALENCE|Bioequivalence was concluded, if the confidence interval (CI) for the comparison of geometric least squares means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Ratio of GLSM (%)|101.24|STANDARD_DEVIATION|7.82||0.5895|TWO_SIDED|90.0|97.4|105.24|||ANOVA||"Ratio of Geometric Least Squares Means (GLSM) was calculated as: Fixed dose combination (treatment B)/ free dose combination (treatment A).~Standard deviation is actually intra-individual geometric coefficient of variation (gCV \[%\])."|The statistical model used for the analysis was an analysis of variance (ANOVA) on the logarithmic scale. That is, the PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.||105.24|97.40|0.5895
71916405|NCT01678560|143354510|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|Exact Fisher test was used on the information from the limited population.||PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|Exact Fisher test was used on the collected information from the limited population.|||<0.01
71922328|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccine Group Differences at Day 86|19.0|||||TWO_SIDED|97.5|10.0|28.9|||MN method|||Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA||28.9|10|
71874990|NCT04091451|143268080|NON_INFERIORITY|The non-inferiority was to be demonstrated if the upper limit (UL) of the 95% confidence interval (CI) of the ratio of the incidence of HZ recurrence between HZ/su group and Placebo group was below (\<) 5.|Incidence Rate Ratio (IRR)|0.0|||||TWO_SIDED|95.0|0.0|0.46|||Poisson||IRR = incidence rate of HZ recurrence in HZ/su group divided by the incidence rate of HZ recurrence in Placebo group. Poisson method was used to adjust for differences in follow-up time across individuals.|To demonstrate the non-inferiority of HZ/su vaccine compared to placebo in terms of incidence of HZ recurrence from 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months).||0.46|0.00|
71874991|NCT02087748|143268146|SUPERIORITY_OR_OTHER|||||||0.0324|||||||t-test, 2 sided|||||||0.0324
71874992|NCT02087748|143268147|SUPERIORITY_OR_OTHER|||||||0.3688|||||||t-test, 2 sided|||||||0.3688
71874993|NCT02087748|143268148|SUPERIORITY_OR_OTHER|||||||0.0275|||||||t-test, 2 sided|||||||0.0275
71874994|NCT03078907|143268151|OTHER||Least Square (LS) mean|13.79|STANDARD_ERROR_OF_MEAN|13.695|||TWO_SIDED|95.0|13.366|40.944|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Freedson '98||40.944|13.366|
71874995|NCT03078907|143268151|OTHER||LS means|2.31|STANDARD_ERROR_OF_MEAN|6.601|||TWO_SIDED|95.0|-10.782|15.396|||ANCOVA|||Daily time spent in MVPA (minutes), Freedson '98||15.396|-10.782|
71874996|NCT03078907|143268151|OTHER||LS mean|17.81|STANDARD_ERROR_OF_MEAN|12.008|||TWO_SIDED|95.0|-6.003|41.619|||ANCOVA|||Daily time spent in non-sedentary activity (minutes), Koster '16||41.619|-6.003|
71874997|NCT03078907|143268152|OTHER||LS mean|0.67|STANDARD_ERROR_OF_MEAN|1.204|||TWO_SIDED|95.0|-1.713|3.06|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Freedson '98||3.060|-1.713|
71874998|NCT03078907|143268152|OTHER||LS mean|-0.05|STANDARD_ERROR_OF_MEAN|0.658|||TWO_SIDED|95.0|-1.351|1.258|||ANCOVA|||Percentage of daily time spent in MVPA (%), Freedson '98||1.258|-1.351|
71874999|NCT03078907|143268152|OTHER||LS mean|1.26|STANDARD_ERROR_OF_MEAN|1.191|||TWO_SIDED|95.0|-1.104|3.618|||ANCOVA|||Percentage of daily time spent in non-sedentary activity (%), Koster '16||3.618|-1.104|
71875000|NCT03078907|143268153|OTHER||LS mean|20.66|STANDARD_ERROR_OF_MEAN|63.695|||TWO_SIDED|95.0|-105.632|146.958|||ANCOVA|||Volume of total daily activities (counts / minute)||146.958|-105.632|
71875001|NCT03078907|143268153|OTHER||LS means|27.52|STANDARD_ERROR_OF_MEAN|65.291|||TWO_SIDED|95.0|-101.945|156.976|||ANCOVA|||Volume of non-sedentary activity (counts/minute), Koster '16||156.976|-101.945|
71875002|NCT03078907|143268154|OTHER||LS means|58409.0|STANDARD_ERROR_OF_MEAN|64985.0|||TWO_SIDED|95.0|-70444.0|187263.0|||ANCOVA|||||187263|-70444|
71916406|NCT01678560|143354511|OTHER|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|TWO_SIDED|||||"Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.~Exact Fisher test was used on the collected information from the limited population."|Fisher Exact|Exact Fisher test was used on the information from the limited population||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm|Exact Fisher test was used on the collected information from the limited population|||<0.01
71916407|NCT01678560|143354512|OTHER|Exact Fisher test was used on the collected information from the limited population|Estimation Parameter Other[Fisher exact|1.0|||<|0.01|TWO_SIDED|||||Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.||||<0.01
71875003|NCT03078907|143268155|OTHER||LS means|201.59|STANDARD_ERROR_OF_MEAN|224.212|||TWO_SIDED|95.0|-242.977|646.163|||ANCOVA|||||646.163|-242.977|
71875004|NCT03078907|143268156|OTHER||LS means|0.07|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|95.0|-0.366|0.51|||ANCOVA|||||0.510|-0.366|
71875005|NCT03808688|143268186|OTHER|Descriptive statistics included the number of subjects/eyes(n), mean, SD, median, minimum, and maximum for continuous variables, and frequency and percentages for categorical variables.||||||||||||||||Cohorts assessed versus baseline treatment|All efficacy data were summarized at each timepoint using appropriate descriptive statistics for the overall populations as well as separately for monotherapy and concomitant therapy groups.|||
71875006|NCT03801902|143268234|OTHER||||||||||||||||||"If 0-1 of initial 6 evaluable patients on an arm have a safety event, then the regimen will be deemed safe and that arm will continue to the second part of the study to enroll 6 additional evaluable patients. However, if 2 or more of the 6 patients develop a safety event, then that arm is considered not safe and will not continue to second part. The probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% is at least 77%. If the true toxicity rate is ≤ 18%, then the probability that the treatment will be deemed to be safe is at least 70%.~If fewer than 4 of the total of 12 evaluable patients on an arm experience a safety event, then the treatment will be considered tolerable. With a cohort of 12 patients, the probability of the treatment being judged to be too toxic when the true toxicity rate is ≥ 40% at least 78%. If the true toxicity rate is ≤ 18%, the probability that the treatment will be deemed to be safe is 85%."|||
71875007|NCT03258554|143268241|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.8878|TWO_SIDED|95.0|0.84|2.12||One-sided significance level = 0.2|Log Rank||Reference arm = radiation therapy + cetuximab|Sixty-nine progression-free survival (PFS) events provides 0.80 power for a log-rank test with one-sided alpha of 0.20 to detect an improvement in PFS corresponding to a median of 2.35 years (RT+Durvalumab) compared to 1.53 years (RT+Cetuximab). A hazard ratio (RT+Durvalumab/RT+Cetuximab) ≤ 0.806 would indicate a rejection of the null hypothesis (no difference between the arms) and the study would continue to phase III; otherwise, the study would not continue to phase III.||2.12|0.84|0.8878
71683973|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from baseline to post-intervention. Null hypothesis: there would be no significant differences in avoidance from baseline to post-intervention||||>0.05
71683974|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||<|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in avoidance of target thought from post-intervention to follow-up. Null hypothesis: there would be no significant differences in avoidance from post-intervention to follow-up.||||<0.05
71875008|NCT03258554|143268242|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.8175|TWO_SIDED|95.0|0.74|2.28||One-side significance level = 0.025|Log Rank|||||2.28|0.74|0.8175
71875009|NCT03258554|143268243|SUPERIORITY||Hazard Ratio (HR)|1.71||||0.1001|TWO_SIDED|95.0|0.89|3.28||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||3.28|0.89|0.1001
71875010|NCT03258554|143268244|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.5197|TWO_SIDED|95.0|0.32|1.77||Two-sided significance level = 0.05|Log Rank||Reference level = RT+ Cetuximab|||1.77|0.32|0.5197
71875011|NCT03258554|143268245|SUPERIORITY||Hazard Ratio (HR)|1.75||||0.3201|TWO_SIDED|95.0|0.57|5.38||Two-sided significance level = 0.05|Log Rank|||||5.38|0.57|0.3201
71875012|NCT03258554|143268246|SUPERIORITY|||||||1||||||Two-sided significance level = 0.05|Fisher Exact|||||||1.00
71875013|NCT03258554|143268247|SUPERIORITY|||||||0.0688||||||Two-side significance level = 0.05|Fisher Exact|||||||0.0688
71875014|NCT03258554|143268250|SUPERIORITY||Cox Proportional Hazard|1.11|||||TWO_SIDED|95.0|0.62|1.97|||||Reference arm = RT + Cetuximab|CPS ≥ 1||1.97|0.62|
71875015|NCT03258554|143268250|SUPERIORITY||Cox Proportional Hazard|1.64|||||TWO_SIDED|95.0|0.66|4.06|||||Reference arm = RT + Cetuximab|CPS = 0||4.06|0.66|
71875016|NCT03258554|143268250|SUPERIORITY|||||||0.41||||||Testing the interaction of treatment arm and PD-L1 expression (CPS ≥ 1, CPS = 0)|Regression, Cox|||Interaction||||0.41
71875017|NCT03258554|143268251|SUPERIORITY||Hazard Ratio (HR)|1.2|||||TWO_SIDED|95.0|0.57|2.51|||||Reference arm = RT + cetuximab|p16-positive||2.51|0.57|
71875018|NCT03258554|143268251|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.83|2.89|||||Reference arm = RT + cetuximab|p16-negative||2.89|0.83|
71875019|NCT03258554|143268251|SUPERIORITY|||||||0.61||||||Testing the interaction of treatment arm and p16 status (positive, negative)|Regression, Cox|||Interaction||||0.61
71916408|NCT01678560|143354513|OTHER|Exact Fisher test was used on the collected information from the limited population|Other[Fisher exact test statistic value]|0.0286|||<|0.01|TWO_SIDED|||||Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population|Fisher Exact||Exact Fisher test was used on the collected information from the limited population.|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population.|||<0.01
71916409|NCT01678560|143354514|OTHER|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test|0.0039|||<|0.01|TWO_SIDED|||||"Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.~Exact Fisher test was used on the collected information from the limited population"|Fisher Exact|Exact Fisher test was used on the collected information from the limited population||Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population|||<0.01
71875020|NCT01601847|143268265|SUPERIORITY||Risk Ratio (RR)|0.66||||0.02|TWO_SIDED|95.0|0.47|0.94|||Poisson|Poisson regression using GEE with robust variance estimation (e.g. Zou, American Journal Epidemiology, 2004)||||0.94|0.47|0.02
71875021|NCT01601847|143268265|SUPERIORITY||Odds Ratio (OR)|0.522||||0.0185|TWO_SIDED|95.0|0.304|0.897|||logistic regression with GEE|||||0.897|0.304|0.0185
71875022|NCT01601847|143268266|SUPERIORITY|||||||0.228|||||||Regression, Logistic|||For secondary outcomes, GEE is used to assess randomization arm association.||||0.228
71875023|NCT01601847|143268267|SUPERIORITY|||||||0.798|||||||Regression, Logistic|||||||0.798
71875024|NCT01284062|143268268|SUPERIORITY_OR_OTHER||Least squares (LS) mean|0.41|||||TWO_SIDED|80.0|0.225|0.766|||||LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.|||0.766|0.225|
71875025|NCT01284062|143268268|SUPERIORITY_OR_OTHER||LS mean|0.29|||||TWO_SIDED|80.0|0.187|0.446|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||0.446|0.187|
71875026|NCT01284062|143268268|SUPERIORITY_OR_OTHER||LS mean|0.79|||||TWO_SIDED|80.0|0.517|1.203|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.203|0.517|
71875027|NCT01284062|143268268|SUPERIORITY_OR_OTHER||LS mean|1.24|||||TWO_SIDED|80.0|0.794|1.949|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.|||1.949|0.794|
71875028|NCT01284062|143268268|SUPERIORITY_OR_OTHER||LS mean ratio|0.7||||0.532|TWO_SIDED|80.0|0.329|1.472|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.472|0.329|0.5320
71875029|NCT01284062|143268268|SUPERIORITY_OR_OTHER||LS mean ratio|1.9||||0.27|TWO_SIDED|80.0|0.9|4.013|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||4.013|0.900|0.2700
71875030|NCT01284062|143268268|SUPERIORITY_OR_OTHER||LS mean ratio|3.0||||0.0666|TWO_SIDED|80.0|1.403|6.409|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||6.409|1.403|0.0666
71875031|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.7|||||TWO_SIDED|80.0|0.466|1.048||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.048|0.466|
71875032|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.81|||||TWO_SIDED|80.0|0.552|1.185||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.185|0.552|
71875033|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.71|||||TWO_SIDED|80.0|0.488|1.027||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.027|0.488|
71875034|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.77|||||TWO_SIDED|80.0|0.5|1.195||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.195|0.500|
71875035|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.631|1.328||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.328|0.631|
71875036|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.47|||||TWO_SIDED|80.0|0.339|0.655||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.655|0.339|
71875037|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.92|||||TWO_SIDED|80.0|0.669|1.269||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.269|0.669|
71875038|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.55|||||TWO_SIDED|80.0|0.388|0.779||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.779|0.388|
71875039|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.78|||||TWO_SIDED|80.0|0.454|1.331||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.331|0.454|
71875040|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.36|||||TWO_SIDED|80.0|0.236|0.553||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.553|0.236|
71875041|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|1.14|||||TWO_SIDED|80.0|0.757|1.722||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.722|0.757|
71875042|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.52|||||TWO_SIDED|80.0|0.338|0.788||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.788|0.338|
71875043|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.64|||||TWO_SIDED|80.0|0.374|1.084||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.084|0.374|
71875044|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.19|||||TWO_SIDED|80.0|0.122|0.297||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||0.297|0.122|
71875045|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.96|||||TWO_SIDED|80.0|0.623|1.465||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.465|0.623|
71875046|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean|0.67|||||TWO_SIDED|80.0|0.411|1.076||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.||1.076|0.411|
71875047|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.16||||0.7352|TWO_SIDED|80.0|0.663|2.021|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.021|0.663|0.7352
71875048|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9754|TWO_SIDED|80.0|0.586|1.753|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.753|0.586|0.9754
71875049|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.11||||0.8277|TWO_SIDED|80.0|0.609|2.008|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.008|0.609|0.8277
71875050|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|0.51||||0.0885|TWO_SIDED|80.0|0.313|0.846|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.846|0.313|0.0885
71875051|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.01||||0.9856|TWO_SIDED|80.0|0.617|1.644|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.644|0.617|0.9856
71875052|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|0.6||||0.1996|TWO_SIDED|80.0|0.361|1.0|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.000|0.361|0.1996
71875053|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|0.46||||0.1553|TWO_SIDED|80.0|0.233|0.926|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.926|0.233|0.1553
71875054|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.47||||0.4633|TWO_SIDED|80.0|0.748|2.882|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.882|0.748|0.4633
71875055|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|0.66||||0.4409|TWO_SIDED|80.0|0.335|1.316|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||1.316|0.335|0.4409
71875056|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|0.3||||0.0283|TWO_SIDED|80.0|0.15|0.598|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||0.598|0.150|0.0283
71683975|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would show equal avoidance of target thought||||>0.05
71758554|NCT02205736|143019222|SUPERIORITY|||||||0.4142||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 21 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.4142
71875057|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.5||||0.4434|TWO_SIDED|80.0|0.758|2.97|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.970|0.758|0.4434
71875058|NCT01284062|143268275|SUPERIORITY_OR_OTHER||LS mean ratio|1.04||||0.9372|TWO_SIDED|80.0|0.51|2.141|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).||2.141|0.510|0.9372
71875059|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percentage of participants|41.67|||||TWO_SIDED|80.0|25.53|59.81|||||CI was assessed by Wilson score method.|||59.81|25.53|
71875060|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percentage of participants|60.0|||||TWO_SIDED|80.0|43.59|74.43|||||CI was assessed by Wilson score method.|||74.43|43.59|
71875061|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|80.0|34.74|65.26|||||CI was assessed by Wilson score method.|||65.26|34.74|
71875062|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percentage of participants|15.38|||||TWO_SIDED|80.0|6.58|31.96|||||CI was assessed by Wilson score method.|||31.96|6.58|
71875063|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percent difference|18.33||||0.4495|TWO_SIDED|80.0|-6.13|39.98|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||39.98|-6.13|0.4495
71875064|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percent difference|8.33||||0.7177|TWO_SIDED|80.0|-15.37|30.54|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||30.54|-15.37|0.7177
71875065|NCT01284062|143268280|SUPERIORITY_OR_OTHER||percent difference|-26.28||||0.2016|TWO_SIDED|80.0|-46.45|-3.15|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-3.15|-46.45|0.2016
71875066|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percentage of participants|16.67|||||TWO_SIDED|80.0|7.14|34.22|||||CI was assessed by Wilson score method.|||34.22|7.14|
71875067|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percentage of participants|33.33|||||TWO_SIDED|80.0|20.08|49.88|||||CI was assessed by Wilson score method.|||49.88|20.08|
71875068|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percentage of participants|18.75|||||TWO_SIDED|80.0|9.4|33.92|||||CI was assessed by Wilson score method.|||33.92|9.40|
71875069|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|80.0|0.0|11.22|||||CI was assessed by Wilson score method.|||11.22|0.00|
71875070|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percent difference|16.67||||0.4082|TWO_SIDED|80.0|-5.33|35.76|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||35.76|-5.33|0.4082
71875071|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percent difference|2.08||||1|TWO_SIDED|80.0|-17.8|19.99|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||19.99|-17.80|1.0000
71875072|NCT01284062|143268281|SUPERIORITY_OR_OTHER||percent difference|-16.67||||0.22|TWO_SIDED|80.0|-34.22|-1.95|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher's exact test.||-1.95|-34.22|0.2200
71875073|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean|-1.32|||||TWO_SIDED|80.0|-2.332|-0.3||||||||-0.300|-2.332|
71875074|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean|-2.28|||||TWO_SIDED|80.0|-3.19|-1.374||||||||-1.374|-3.190|
71875075|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean|-2.3|||||TWO_SIDED|80.0|-3.178|-1.419||||||||-1.419|-3.178|
71875076|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean|-0.79|||||TWO_SIDED|80.0|-1.761|0.19||||||||0.190|-1.761|
71875077|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean difference|-0.97||||0.3639|TWO_SIDED|80.0|-2.335|0.403|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.403|-2.335|0.3639
71875078|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean difference|-0.98||||0.3446|TWO_SIDED|80.0|-2.32|0.355|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||0.355|-2.320|0.3446
71875079|NCT01284062|143268282|SUPERIORITY_OR_OTHER||LS mean difference|0.53||||0.6285|TWO_SIDED|80.0|-0.884|1.945|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.||1.945|-0.884|0.6285
71875080|NCT04721821|143268352|SUPERIORITY||Odds Ratio (OR)|1.09|||||TWO_SIDED|95.0|0.82|1.44||||||||1.44|0.82|
71875081|NCT04721821|143268353|SUPERIORITY||Odds Ratio (OR)|0.72|||||TWO_SIDED|95.0|0.44|1.16||||||||1.16|0.44|
71875082|NCT04721821|143268354|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.73|1.27||||||||1.27|0.73|
71875083|NCT04721821|143268355|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.79|1.88||||||||1.88|0.79|
71875084|NCT04721821|143268356|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.79|1.67||||||||1.67|0.79|
71875085|NCT04721821|143268357|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.94|1.76||||||||1.76|0.94|
71875086|NCT04721821|143268358|SUPERIORITY||Odds Ratio (OR)|1.15|||||TWO_SIDED|95.0|0.7|1.89||||||||1.89|0.70|
71875087|NCT04721821|143268359|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.69|1.32||||||||1.32|0.69|
71875088|NCT04721821|143268360|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.81|2.16||||||||2.16|0.81|
71875089|NCT04721821|143268361|SUPERIORITY||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.81|1.87||||||||1.87|0.81|
71875090|NCT04721821|143268362|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.8|1.66||||||Month 6 follow-up visit analysis||1.66|0.80|
71875091|NCT04721821|143268362|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.75|1.65||||||Month 12 follow-up visit analysis||1.65|0.75|
71875092|NCT04721821|143268363|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.57|1.99||||||Month 6 follow-up visit analysis||1.99|0.57|
71683976|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal avoidance of target thought||||>0.05
71916410|NCT00654368|143354539|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the one-sided 95% confidence interval (CI), defined below, exceeded the noninferiority margin of -0.6, then noninferiority was to be concluded.|Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.75|-0.06|||||The 95% CI was calculated using the mean square error from an analysis of variance (ANOVA) fitted with effects for treatment and covariates of duration of disease, type of reimbursement, and 6 month DAS28.|||-0.06|-0.75|
71916411|NCT03296072|143354552|OTHER||Difference of Least Square mean|7.69|||<|0.0001|TWO_SIDED|95.0|5.18|10.19|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||10.19|5.18|<.0001
71916412|NCT03296072|143354553|OTHER||Difference of Least Square mean|33.29|||<|0.0001|TWO_SIDED|95.0|28.89|37.68|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||37.68|28.89|<.0001
71916413|NCT03296072|143354554|OTHER||Difference of Least Square mean|1.81|||<|0.0001|TWO_SIDED|95.0|1.59|2.04|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||2.04|1.59|<.0001
71916414|NCT03296072|143354555|OTHER||Difference of Least Square mean|7.57|||<|0.0001|TWO_SIDED|95.0|5.07|11.07|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||11.07|5.07|<.0001
71875093|NCT04721821|143268363|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.49|1.75||||||Month 12 follow-up visit analysis||1.75|0.49|
71916415|NCT03296072|143354556|OTHER||Difference of Least Square mean|10.98|||<|0.0001|TWO_SIDED|95.0|6.58|15.37|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||15.37|6.58|<.0001
71916416|NCT03296072|143354557|OTHER||Difference of Least Square mean|0.97|||<|0.0001|TWO_SIDED|95.0|0.75|1.2|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.|||1.20|0.75|<.0001
71916417|NCT00804986|143354558|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.47||||0.0109|TWO_SIDED|95.0|-0.83|-0.11||p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.11|-0.83|0.0109
71875094|NCT04721821|143268364|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.79|1.58||||||Month 6 follow-up visit analysis||1.58|0.79|
71916418|NCT00804986|143354558|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.67||||0.0003|TWO_SIDED|95.0|-1.02|-0.31||p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.31|-1.02|0.0003
71916419|NCT00804986|143354558|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.11|||<|0.0001|TWO_SIDED|95.0|-1.46|-0.76||p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.76|-1.46|<0.0001
71875095|NCT04721821|143268364|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.6|1.35||||||Month 12 follow-up visit analysis||1.35|0.60|
71875096|NCT04721821|143268365|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.77|2.29||||||Month 6 follow-up visit analysis||2.29|0.77|
71875097|NCT04721821|143268365|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.82|2.71||||||Month 12 follow-up visit analysis||2.71|0.82|
71875098|NCT04721821|143268366|SUPERIORITY||Odds Ratio (OR)|1.35|||||TWO_SIDED|95.0|0.81|2.24||||||Month 6 follow-up visit analysis||2.24|0.81|
71875099|NCT04721821|143268366|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.62||||||Month 12 follow-up visit analysis||1.62|0.50|
71875100|NCT04721821|143268367|SUPERIORITY||Mean Difference (Net)|0.21|||||TWO_SIDED|95.0|-0.88|1.31||||||Month 6 follow-up visit analysis||1.31|-0.88|
71875101|NCT04721821|143268367|SUPERIORITY||Mean Difference (Net)|-1.5|||||TWO_SIDED|95.0|-2.73|-0.27||||||Month 12 follow-up visit analysis||-0.27|-2.73|
71875102|NCT04721821|143268368|SUPERIORITY||Median Difference (Net)|0.39|||||TWO_SIDED|95.0|-1.24|2.02||||||Month 6 follow-up visit analysis||2.02|-1.24|
71875103|NCT04721821|143268368|SUPERIORITY||Median Difference (Net)|0.96|||||TWO_SIDED|95.0|-0.92|2.84||||||Month 12 follow-up visit analysis||2.84|-0.92|
71875104|NCT04721821|143268369|SUPERIORITY||Mean Difference (Net)|-0.56|||||TWO_SIDED|95.0|-1.68|0.56||||||Month 6 follow-up visit analysis||0.56|-1.68|
71875105|NCT04721821|143268369|SUPERIORITY||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|-0.51|1.99||||||Month 12 follow-up visit analysis||1.99|-0.51|
71875106|NCT04721821|143268370|SUPERIORITY||Mean Difference (Net)|-1.11|||||TWO_SIDED|95.0|-2.66|0.45||||||Month 6 follow-up visit analysis||0.45|-2.66|
71875107|NCT04721821|143268370|SUPERIORITY||Mean Difference (Net)|-1.73|||||TWO_SIDED|95.0|-3.52|0.05||||||Month 12 follow-up visit analysis||0.05|-3.52|
71875108|NCT04721821|143268371|SUPERIORITY||Mean Difference (Net)|-0.93|||||TWO_SIDED|95.0|-2.3|0.44||||||Month 6 follow-up visit analysis||0.44|-2.30|
71875109|NCT04721821|143268371|SUPERIORITY||Mean Difference (Net)|-0.99|||||TWO_SIDED|95.0|-2.6|0.62||||||Month 12 follow-up visit analysis||0.62|-2.60|
71875110|NCT04721821|143268372|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.8|1.35||||||Month 6 follow-up visit analysis: mACR 20||1.35|0.80|
71875111|NCT04721821|143268372|SUPERIORITY||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.86|1.67||||||Month 6 follow-up visit analysis: mACR 50||1.67|0.86|
71875112|NCT04721821|143268372|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.57|1.54||||||Month 6 follow-up visit analysis: mACR 70||1.54|0.57|
71875113|NCT04721821|143268372|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.41||||||Month 12 follow-up visit analysis: mACR 20||1.41|0.77|
71875114|NCT04721821|143268372|SUPERIORITY||Odds Ratio (OR)|1.32|||||TWO_SIDED|95.0|0.89|1.95||||||Month 12 follow-up visit analysis: mACR 50||1.95|0.89|
71875115|NCT04721821|143268372|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.85|2.6||||||Month 12 follow-up visit analysis: mACR 70||2.60|0.85|
71875116|NCT04721821|143268373|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.34||||||Month 6 follow-up visit analysis: mACR 20||1.34|0.59|
71875117|NCT04721821|143268373|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.39|1.15||||||Month 6 follow-up visit analysis: mACR 50||1.15|0.39|
71875118|NCT04721821|143268373|SUPERIORITY||Odds Ratio (OR)|0.79|||||TWO_SIDED|95.0|0.34|1.83||||||Month 6 follow-up visit analysis: mACR 70||1.83|0.34|
71875119|NCT04721821|143268373|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.56|1.42||||||Month 12 follow-up visit analysis: mACR 20||1.42|0.56|
71875120|NCT04721821|143268373|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.46|1.8||||||Month 12 follow-up visit analysis: mACR 50||1.80|0.46|
71875121|NCT04721821|143268373|SUPERIORITY||Odds Ratio (OR)|0.54|||||TWO_SIDED|95.0|0.19|1.48||||||Month 12 follow-up visit analysis: mACR 70||1.48|0.19|
71875122|NCT04721821|143268374|SUPERIORITY||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.86|1.45||||||Month 6 follow-up visit analysis: mACR 20||1.45|0.86|
71875123|NCT04721821|143268374|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.67|1.26||||||Month 6 follow-up visit analysis: mACR 50||1.26|0.67|
71875124|NCT04721821|143268374|SUPERIORITY||Odds Ratio (OR)|0.69|||||TWO_SIDED|95.0|0.44|1.09||||||Month 6 follow-up visit analysis: mACR 70||1.09|0.44|
71875125|NCT04721821|143268374|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.74|1.38||||||Month 12 follow-up visit analysis: mACR 20||1.38|0.74|
71875126|NCT04721821|143268374|SUPERIORITY||Odds Ratio (OR)|1.03|||||TWO_SIDED|95.0|0.69|1.52||||||Month 12 follow-up visit analysis: mACR 50||1.52|0.69|
71875127|NCT04721821|143268374|SUPERIORITY||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.46|1.33||||||Month 12 follow-up visit analysis: mACR 70||1.33|0.46|
71875128|NCT04721821|143268375|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.78|1.77||||||Month 6 follow-up visit analysis: mACR 20||1.77|0.78|
71875129|NCT04721821|143268375|SUPERIORITY||Odds Ratio (OR)|1.17|||||TWO_SIDED|95.0|0.71|1.95||||||Month 6 follow-up visit analysis: mACR 50||1.95|0.71|
71875130|NCT04721821|143268375|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.45|2.39||||||Month 6 follow-up visit analysis: mACR 70||2.39|0.45|
71875131|NCT04721821|143268375|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.5|1.4||||||Month 12 follow-up visit analysis: mACR 20||1.40|0.50|
71875132|NCT04721821|143268375|SUPERIORITY||Odds Ratio (OR)|0.95|||||TWO_SIDED|95.0|0.49|1.83||||||Month 12 follow-up visit analysis: mACR 50||1.83|0.49|
71875133|NCT04721821|143268375|SUPERIORITY||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.33|1.95||||||Month 12 follow-up visit analysis: mACR 70||1.95|0.33|
71875134|NCT04721821|143268376|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.76|1.49||||||Month 6 follow-up visit analysis: mACR 20||1.49|0.76|
71875135|NCT04721821|143268376|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||Month 6 follow-up visit analysis: mACR 50||1.37|0.55|
71875136|NCT04721821|143268376|SUPERIORITY||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.32|1.2||||||Month 6 follow-up visit analysis: mACR 70||1.20|0.32|
71875137|NCT04721821|143268376|SUPERIORITY||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.59|1.3||||||Month 12 follow-up visit analysis: mACR 20||1.30|0.59|
71875138|NCT04721821|143268376|SUPERIORITY||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.65|1.86||||||Month 12 follow-up visit analysis: mACR 50||1.86|0.65|
71875139|NCT04721821|143268376|SUPERIORITY||Odds Ratio (OR)|1.43||||||95.0|0.62|3.28||||||Month 12 follow-up visit analysis: mACR 70||3.28|0.62|
71875140|NCT04721821|143268377|SUPERIORITY||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|0.94|2.15||||||Month 6 follow-up visit analysis||2.15|0.94|
71875141|NCT04721821|143268377|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.68|1.84||||||Month 12 follow-up visit analysis||1.84|0.68|
71875142|NCT04721821|143268378|SUPERIORITY||Odds Ratio (OR)|0.82|||||TWO_SIDED|95.0|0.41|1.67||||||Month 6 follow-up visit analysis||1.67|0.41|
71875143|NCT04721821|143268378|SUPERIORITY||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.62|3.07||||||Month 12 follow-up visit analysis||3.07|0.62|
71875144|NCT04721821|143268379|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.52||||||Month 6 follow-up visit analysis||1.52|0.66|
71875145|NCT04721821|143268379|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.64|1.74||||||Month 12 follow-up visit analysis||1.74|0.64|
71875146|NCT04721821|143268380|SUPERIORITY||Odds Ratio (OR)|1.54|||||TWO_SIDED|95.0|0.8|2.94||||||Month 6 follow-up visit analysis||2.94|0.80|
71875147|NCT04721821|143268380|SUPERIORITY||Odds Ratio (OR)|1.72|||||TWO_SIDED|95.0|0.76|3.87||||||Month 12 follow-up visit analysis||3.87|0.76|
71875148|NCT04721821|143268381|SUPERIORITY||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.73|2.27||||||Month 6 follow-up visit analysis||2.27|0.73|
71875149|NCT04721821|143268381|SUPERIORITY||Odds Ratio (OR)|1.18|||||TWO_SIDED|95.0|0.63|2.23||||||Month 12 follow-up visit analysis||2.23|0.63|
71916420|NCT00804986|143354558|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.28|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.93||p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.93|-1.64|<0.0001
71916421|NCT00804986|143354558|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.24|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.88||p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values \<0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction||||-0.88|-1.59|<0.0001
71916422|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|1.93||||0.655||95.0||||p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.655
71875150|NCT04721821|143268382|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
71875151|NCT04721821|143268382|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|-0.01|0.09||||||Month 12 follow-up visit analysis||0.09|-0.01|
71916423|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.36||||0.436||95.0||||p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.436
71916424|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.45||||0.914||95.0||||p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.914
71916425|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|3.3||||0.446||95.0||||p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.446
71916426|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.84||||0.508||95.0||||p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.508
71916427|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|2.89||||0.561||95.0||||p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.561
71875152|NCT04721821|143268383|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06||||||Month 6 follow-up visit analysis||0.06|-0.08|
71916428|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7.4||||0.135||95.0||||p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.135
71916429|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.45||||0.357||95.0||||p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.357
71916430|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-8.05||||0.105||95.0||||p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.105
71916431|NCT00804986|143354559|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.02||||0.221||95.0||||p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.221
71875153|NCT04721821|143268383|SUPERIORITY||Median Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.11|0.05||||||Month 12 follow-up visit analysis||0.05|-0.11|
71875154|NCT04721821|143268384|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.07|0.03||||||Month 6 follow-up visit analysis||0.03|-0.07|
71875155|NCT04721821|143268384|SUPERIORITY||Odds Ratio (OR)|0.01|||||TWO_SIDED|95.0|-0.05|0.07||||||Month 12 follow-up visit analysis||0.07|-0.05|
71875156|NCT04721821|143268385|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.07||||||Month 6 follow-up visit analysis||0.07|-0.06|
71875157|NCT04721821|143268385|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.12|0.06||||||Month 12 follow-up visit analysis||0.06|-0.12|
71875158|NCT04721821|143268386|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.09|0.04||||||Month 6 follow-up visit analysis||0.04|-0.09|
71875159|NCT04721821|143268386|SUPERIORITY||Odds Ratio (OR)|0.02|||||TWO_SIDED|95.0|-0.06|0.09||||||Month 12 follow-up visit analysis||0.09|-0.06|
71875160|NCT04721821|143268387|SUPERIORITY||Odds Ratio (OR)|1.14|||||TWO_SIDED|95.0|0.9|1.45||||||Month 6 follow-up visit analysis||1.45|0.90|
71875161|NCT04721821|143268387|SUPERIORITY||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.54|0.94||||||Month 12 follow-up visit analysis||0.94|0.54|
71875162|NCT04721821|143268388|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.53|1.11||||||Month 6 follow-up visit analysis||1.11|0.53|
71875163|NCT04721821|143268388|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.72|1.61||||||Month 12 follow-up visit analysis||1.61|0.72|
71683977|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in avoidance of target thought||||>0.05
71683978|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in avoidance of target thought across time.||||>0.05
71683979|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on avoidance of target thought||||>0.05
71758555|NCT02205736|143019222|SUPERIORITY|||||||0.5637||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 22 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.5637
71875164|NCT04721821|143268389|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.73|1.21||||||Month 6 follow-up visit analysis||1.21|0.73|
71875165|NCT04721821|143268389|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.77|1.39||||||Month 12 follow-up visit analysis||1.39|0.77|
71875166|NCT04721821|143268390|SUPERIORITY||Odds Ratio (OR)|0.92|||||TWO_SIDED|95.0|0.64|1.32||||||Month 6 follow-up visit analysis||1.32|0.64|
71875167|NCT04721821|143268390|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.69|1.64||||||Month 12 follow-up visit analysis||1.64|0.69|
71875168|NCT04721821|143268391|SUPERIORITY||Odds Ratio (OR)|1.16|||||TWO_SIDED|95.0|0.84|1.59||||||Month 6 follow-up visit analysis||1.59|0.84|
71875169|NCT04721821|143268391|SUPERIORITY||Odds Ratio (OR)|0.93|||||TWO_SIDED|95.0|0.65|1.32||||||Month 12 follow-up visit analysis||1.32|0.65|
71916432|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-4.54||||0.4848||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4848
71916433|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-19.48||||0.0029||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0029
71875170|NCT04721821|143268392|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.03|0.04||||||Month 6 follow-up visit analysis||0.04|-0.03|
71875171|NCT04721821|143268392|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.04|0.05||||||Month 12 follow-up visit analysis||0.05|-0.04|
71875172|NCT04721821|143268393|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.05|0.05||||||Month 6 follow-up visit analysis||0.05|-0.05|
71875173|NCT04721821|143268393|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.07|0.06||||||Month 12 follow-up visit analysis||0.06|-0.07|
71875174|NCT04721821|143268394|SUPERIORITY||Mean Difference (Final Values)|-0.02|||||TWO_SIDED|95.0|-0.06|0.02||||||Month 6 follow-up visit analysis||0.02|-0.06|
71875175|NCT04721821|143268394|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.04|0.04||||||Month 12 follow-up visit analysis||0.04|-0.04|
71875176|NCT04721821|143268395|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.06|0.04||||||Month 6 follow-up visit analysis||0.04|-0.06|
71875177|NCT04721821|143268395|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.1|0.03||||||Month 12 follow-up visit analysis||0.03|-0.10|
71875178|NCT04721821|143268396|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.05|0.04||||||Month 6 follow-up visit analysis||0.04|-0.05|
71875179|NCT04721821|143268396|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.06|0.06||||||Month 12 follow-up visit analysis||0.06|-0.06|
71875180|NCT04721821|143268397|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.65|2.45||||||Month 6 follow-up visit analysis||2.45|-2.65|
71875181|NCT04721821|143268397|SUPERIORITY||Mean Difference (Final Values)|0.26|||||TWO_SIDED|95.0|-2.59|3.11||||||Month 12 follow-up visit analysis||3.11|-2.59|
71875182|NCT04721821|143268398|SUPERIORITY||Mean Difference (Final Values)|0.83|||||TWO_SIDED|95.0|-2.71|4.38||||||Month 6 follow-up visit analysis||4.38|-2.71|
71875183|NCT04721821|143268398|SUPERIORITY||Mean Difference (Final Values)|-1.09|||||TWO_SIDED|95.0|-5.12|2.95||||||Month 12 follow-up visit analysis||2.95|-5.12|
71758556|NCT02205736|143019222|SUPERIORITY|||||||0.0002||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 23 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0002
71875184|NCT04721821|143268399|SUPERIORITY||Mean Difference (Final Values)|-1.25|||||TWO_SIDED|95.0|-3.94|1.45||||||Month 6 follow-up visit analysis||1.45|-3.94|
71875185|NCT04721821|143268399|SUPERIORITY||Mean Difference (Final Values)|-0.59|||||TWO_SIDED|95.0|-3.61|2.42||||||Month 12 follow-up visit analysis||2.42|-3.61|
71875186|NCT04721821|143268400|SUPERIORITY||Mean Difference (Final Values)|-0.67|||||TWO_SIDED|95.0|-4.39|3.05||||||Month 6 follow-up visit analysis||3.05|-4.39|
71875187|NCT04721821|143268400|SUPERIORITY||Mean Difference (Final Values)|-4.84|||||TWO_SIDED|95.0|-9.19|-0.48||||||Month 12 follow-up visit analysis||-0.48|-9.19|
71875188|NCT04721821|143268401|SUPERIORITY||Mean Difference (Final Values)|-0.39|||||TWO_SIDED|95.0|-3.59|2.82||||||Month 6 follow-up visit analysis||2.82|-3.59|
71875189|NCT04721821|143268401|SUPERIORITY||Mean Difference (Final Values)|0.76|||||TWO_SIDED|95.0|-2.97|4.49||||||Month 12 follow-up visit analysis||4.49|-2.97|
71875190|NCT04721821|143268402|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.73|1.34||||||Month 6 follow-up visit analysis||1.34|0.73|
71875191|NCT04721821|143268402|SUPERIORITY||Odds Ratio (OR)|0.94|||||TWO_SIDED|95.0|0.66|1.34||||||Month 12 follow-up visit analysis||1.34|0.66|
71875192|NCT04721821|143268403|SUPERIORITY||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.62|1.73||||||Month 6 follow-up visit analysis||1.73|0.62|
71875193|NCT04721821|143268403|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.5|1.6||||||Month 12 follow-up visit analysis||1.60|0.50|
71875194|NCT04721821|143268404|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.64|1.19||||||Month 6 follow-up visit analysis||1.19|0.64|
71875195|NCT04721821|143268404|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.6|1.26||||||Month 12 follow-up visit analysis||1.26|0.60|
71875196|NCT04721821|143268405|SUPERIORITY||Odds Ratio (OR)|0.89|||||TWO_SIDED|95.0|0.55|1.46||||||Month 6 follow-up visit analysis||1.46|0.55|
71875197|NCT04721821|143268405|SUPERIORITY||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.47|1.51||||||Month 12 follow-up visit analysis||1.51|0.47|
71875198|NCT04721821|143268406|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.6|1.38||||||Month 6 follow-up visit analysis||1.38|0.60|
71875199|NCT04721821|143268406|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.56|1.5||||||Month 12 follow-up visit analysis||1.50|0.56|
71875200|NCT04721821|143268407|SUPERIORITY||Mean Difference (Final Values)|1.71|||||TWO_SIDED|95.0|-0.69|4.11||||||Month 6 follow-up visit analysis||4.11|-0.69|
71875201|NCT04721821|143268407|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-2.79|2.77||||||Month 12 follow-up visit analysis||2.77|-2.79|
71875202|NCT04721821|143268408|SUPERIORITY||Mean Difference (Final Values)|-1.71|||||TWO_SIDED|95.0|-5.02|1.6||||||Month 6 follow-up visit analysis||1.60|-5.02|
71875203|NCT04721821|143268408|SUPERIORITY||Mean Difference (Final Values)|1.06|||||TWO_SIDED|95.0|-2.85|4.96||||||Month 12 follow-up visit analysis||4.96|-2.85|
71875204|NCT04721821|143268409|SUPERIORITY||Mean Difference (Final Values)|-1.15|||||TWO_SIDED|95.0|-3.75|1.45||||||Month 6 follow-up visit analysis||1.45|-3.75|
71875205|NCT04721821|143268409|SUPERIORITY||Median Difference (Final Values)|-0.53|||||TWO_SIDED|95.0|-3.54|2.47||||||Month 12 follow-up visit analysis||2.47|-3.54|
71875206|NCT04721821|143268410|SUPERIORITY||Mean Difference (Final Values)|1.19|||||TWO_SIDED|95.0|-2.36|4.73||||||Month 6 follow-up visit analysis||4.73|-2.36|
71875207|NCT04721821|143268410|SUPERIORITY||Mean Difference (Final Values)|-3.15|||||TWO_SIDED|95.0|-7.36|1.07||||||Month 12 follow-up visit analysis||1.07|-7.36|
71875208|NCT04721821|143268411|SUPERIORITY||Mean Difference (Final Values)|2.37|||||TWO_SIDED|95.0|-0.66|5.41||||||Month 6 follow-up visit analysis||5.41|-0.66|
71875209|NCT04721821|143268411|SUPERIORITY||Mean Difference (Final Values)|1.01|||||TWO_SIDED|95.0|-2.69|4.71||||||Month 12 follow-up visit analysis||4.71|-2.69|
71875210|NCT04721821|143268412|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.16|0.4||||||Month 6 follow-up visit analysis||0.40|-0.16|
71875211|NCT04721821|143268412|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.21|0.45||||||Month 12 follow-up visit analysis||0.45|-0.21|
71875212|NCT04721821|143268413|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.4|0.43||||||Month 6 follow-up visit analysis||0.43|-0.40|
71875213|NCT04721821|143268413|SUPERIORITY||Mean Difference (Final Values)|-0.23|||||TWO_SIDED|95.0|-0.74|0.29||||||Month 12 follow-up visit analysis||0.29|-0.74|
71875214|NCT04721821|143268414|SUPERIORITY||Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-0.51|0.1||||||Month 6 follow-up visit analysis||0.10|-0.51|
71875215|NCT04721821|143268414|SUPERIORITY||Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.42|0.31||||||Month 12 follow-up visit analysis||0.31|-0.42|
71875216|NCT04721821|143268415|SUPERIORITY||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.34|0.32||||||Month 6 follow-up visit analysis||0.32|-0.34|
71875217|NCT04721821|143268415|SUPERIORITY||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.69|0.31||||||Month 12 follow-up visit analysis||0.31|-0.69|
71875218|NCT04721821|143268416|SUPERIORITY||Mean Difference (Final Values)|-0.03|||||TWO_SIDED|95.0|-0.37|0.32||||||Month 6 follow-up visit analysis||0.32|-0.37|
71875219|NCT04721821|143268416|SUPERIORITY||Mean Difference (Final Values)|0.15|||||TWO_SIDED|95.0|-0.3|0.59||||||Month 12 follow-up visit analysis||0.59|-0.30|
71875220|NCT03829319|143268448|OTHER||Hazard Ratio (HR)|0.88||||0.07976|TWO_SIDED|95.0|0.74|1.05|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.05|0.74|0.07976
71683980|NCT03646305|142886286|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on avoidance of target thought||||>0.05
71875221|NCT03829319|143268449|OTHER||Hazard Ratio (HR)|1.05||||0.70818|TWO_SIDED|95.0|0.88|1.26|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.26|0.88|0.70818
71875222|NCT03829319|143268450|OTHER||Percent Difference|6.3||||0.08643|TWO_SIDED|95.0|-2.8|15.4|||Stratified Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.||Comparison based on Miettinen \& Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50% ).||15.4|-2.8|0.08643
71875223|NCT03829319|143268454|OTHER||Difference in Least Square Means|-1.01||||0.4805|TWO_SIDED|95.0|-3.83|1.8|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||1.80|-3.83|0.4805
71875224|NCT03829319|143268455|OTHER||Difference in Least Square Means|-0.29||||0.8747|TWO_SIDED|95.0|-3.95|3.36|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||3.36|-3.95|0.8747
71875225|NCT03829319|143268456|OTHER||Difference in Least Square Means|-0.91||||0.5941|TWO_SIDED|95.0|-4.24|2.43|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status (\<50% versus ≥50%)) as covariates.||2.43|-4.24|0.5941
71875226|NCT03829319|143268457|OTHER||covariate|-2.16||||0.3115|TWO_SIDED|95.0|-6.36|2.03|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.03|-6.36|0.3115
71916434|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-32.52|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916435|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-30.45|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916436|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.25|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916437|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5.32||||0.6279||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6279
71916438|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.72||||0.0072||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0072
71916439|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-42.49|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916440|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.05||||0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
71916441|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-51.38|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916442|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-20.21||||0.0335||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0335
71916443|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.91||||0.0221||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0221
71875227|NCT03829319|143268458|OTHER||covariate|-0.37||||0.8134|TWO_SIDED|95.0|-3.47|2.72|||t-test, 2 sided|||Comparision based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors (baseline ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and baseline PD-L1 Status ( \<50% versus ≥50%)) as covariates.||2.72|-3.47|0.8134
71875228|NCT03829319|143268459|OTHER||Hazard Ratio (HR)|1.16||||0.2133|TWO_SIDED|95.0|0.92|1.47|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.47|0.92|0.2133
71875229|NCT03829319|143268460|OTHER||Hazard Ratio (HR)|1.41||||0.0377|TWO_SIDED|95.0|1.02|1.94|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.94|1.02|0.0377
71875230|NCT03829319|143268461|OTHER||Hazard Ratio (HR)|0.87||||0.4084|TWO_SIDED|95.0|0.62|1.21|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.21|0.62|0.4084
71916444|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-39.41|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916445|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-36.07||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
71916446|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.36|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916447|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6.41||||0.503||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.5030
71916448|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-12.49||||0.1938||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.1938
71916449|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-33.13||||0.0003||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0003
71916450|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.66||||0.0101||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0101
71916451|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-43.47|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916452|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.69||||0.006||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0060
71916453|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-34.26||||0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0002
71916454|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.55|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916455|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.34|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916456|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-46.26|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916457|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-11.84||||0.2468||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.2468
71683981|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, cognitive delusion were equivalent across time||||>0.05
71683982|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of cognitive defusion||||>0.05
71758557|NCT02205736|143019222|SUPERIORITY|||||||0.0196||||||Each of the 25 co-secondary objectives were tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5%.|McNemar|||Patients gave True/False responses to Question 24 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||0.0196
71916458|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-21.13||||0.0413||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects||||||0.0413
71916459|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.19||||0.0004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0004
71916460|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-29.59||||0.004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0040
71916461|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-49.9|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916462|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-24.02||||0.0199||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0199
71916463|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-35.77||||0.0008||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0008
71916464|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-38.17||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
71916465|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-40.74||||0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0001
71916466|NCT00804986|143354562|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-53.16|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916467|NCT00804986|143354563|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1131.85||||0.4193||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4193
71916468|NCT00804986|143354563|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1471.04||||0.3026||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.3026
71916469|NCT00804986|143354563|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-5547.95|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916470|NCT00804986|143354563|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-6116.19|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916471|NCT00804986|143354563|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-7786.69|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||<0.0001
71916472|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.08||||0.693||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.693
71916473|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.31||||0.104||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.104
71916474|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.13||||0.506||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.506
71916475|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.648||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.648
71916476|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.09||||0.647||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.647
71916477|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.781||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.781
71916478|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.401||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.401
71916479|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.03||||0.464||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.464
71916480|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.42||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.420
71916481|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|0.01||||0.762||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.762
71916482|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.738||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.738
71916483|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.14||||0.277||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.277
71916484|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.094||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.094
71916485|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.792||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.792
71916486|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.21||||0.105||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.105
71916487|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.403||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.403
71916488|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.04||||0.799||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.799
71916489|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.32||||0.029||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.029
71916490|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.12||||0.439||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.439
71916491|NCT00804986|143354566|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.27||||0.062||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment||||||0.062
71916492|NCT00804986|143354567|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.16||||0.8003||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.8003
71916493|NCT00804986|143354567|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.26||||0.6736||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.6736
71683983|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of cognitive defusion||||>0.05
71683984|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of cognitive defusion||||>0.05
71683985|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of cognitive defusion across time.||||>0.05
71683986|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of cognitive defusion||||>0.05
71683987|NCT03646305|142886287|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on levels of cognitive defusion||||>0.05
71683988|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, weight dissatisfaction were equivalent across time.||||<0.001
71683989|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in weight dissatisfaction from baseline to post-intervention. Null hypothesis: there would be no significant differences in weight dissatisfaction from baseline to post-intervention||||<0.001
71875231|NCT03829319|143268462|OTHER||Hazard Ratio (HR)|1.04||||0.7955|TWO_SIDED|95.0|0.79|1.36|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.36|0.79|0.7955
71875232|NCT03829319|143268464|OTHER||Hazard Ratio (HR)|1.04||||0.7191|TWO_SIDED|95.0|0.84|1.28|||Stratified Log Rank|Two-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.||Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (\<50% versus \>=50%).||1.28|0.84|0.7191
71683990|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in weight dissatisfaction from post-intervention to follow-up. Null: there would be no differences in weight dissatisfaction from post-intervention to follow-up||||<0.05
71683991|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal weight dissatisfaction||||>0.05
71683992|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal weight dissatisfaction scores||||>0.05
71683993|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all 4 conditions were equivalent in weight dissatisfaction||||>0.05
71683994|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in weight dissatisfaction across time.||||>0.05
71683995|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on weight dissatisfaction||||>0.05
71683996|NCT03646305|142886288|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on weight dissatisfaction||||>0.05
71875233|NCT04498832|143268465|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was greater than (\>) 1 between groups for each of the comparisons.|GMT ratio|2.81|||||TWO_SIDED|95.0|2.46|3.2|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H1N1||3.20|2.46|
71875234|NCT04498832|143268465|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.25|||||TWO_SIDED|95.0|2.03|2.5|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|A/H3N2-like||2.50|2.03|
71683997|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, appearance dissatisfaction were equivalent across time.||||<0.001
71683998|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from baseline to post-intervention. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from baseline to post-intervention||||>0.05
71683999|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in appearance dissatisfaction from post-intervention to follow-up. Null hypothesis: the control conditions would have no significant difference in appearance dissatisfaction from post-intervention to follow-up.||||<0.001
71916494|NCT00804986|143354567|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-1.53||||0.0123||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0123
71916495|NCT00804986|143354567|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-0.44||||0.4771||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.4771
71916496|NCT00804986|143354567|SUPERIORITY_OR_OTHER||Difference in mean change from baseline|-2.01||||0.0013||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction||||||0.0013
71916497|NCT00815776|143354572|NON_INFERIORITY_OR_EQUIVALENCE|The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.|||||<|0.0096|||||||student's t-test with 2n-2 DoF|||The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(\< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.||||<0.0096
71875235|NCT04498832|143268465|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|2.55|||||TWO_SIDED|95.0|2.31|2.81|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Victoria-like||2.81|2.31|
71875236|NCT04498832|143268465|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was \>1 between groups for each of the comparisons.|GMT ratio|3.12|||||TWO_SIDED|95.0|2.85|3.42|||||The 2-sided 95% CI was based on the student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|B/Yamagata||3.42|2.85|
71875237|NCT04498832|143268466|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|29.7|||||TWO_SIDED|95.0|25.7|33.5|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H1N1||33.5|25.7|
71875238|NCT04498832|143268466|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|28.1|||||TWO_SIDED|95.0|24.0|32.0|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|A/H3N2-like||32.0|24.0|
71875239|NCT04498832|143268466|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|31.4|||||TWO_SIDED|95.0|27.4|35.2|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Victoria-like||35.2|27.4|
71875240|NCT04498832|143268466|SUPERIORITY|Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was \> 0% for each of the comparisons.|Difference in percentage|35.4|||||TWO_SIDED|95.0|31.4|39.3|||||The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|B/Yamagata||39.3|31.4|
71875241|NCT01474863|143268475|SUPERIORITY|||||||0.86|||||||ANOVA|||||||0.86
71875242|NCT03231943|143268532|OTHER||Power model|0.9476|||||TWO_SIDED|90.0|0.8982|0.9971|||||The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1|||0.9971|0.8982|
71875243|NCT03231943|143268533|OTHER||Power model|0.928|||||TWO_SIDED|90.0|0.8877|0.9683|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1|||0.9683|0.8877|
71875244|NCT03231943|143268534|OTHER||Power Model|0.9352|||||TWO_SIDED|90.0|0.897|0.9734|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1|||0.9734|0.8970|
71875245|NCT03231943|143268535|OTHER||Power model|0.7968|||||TWO_SIDED|90.0|0.6424|0.9512|||||The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1|||0.9512|0.6424|
71875246|NCT03231943|143268536|OTHER||Power model|0.789|||||TWO_SIDED|90.0|0.6149|0.9631|||||The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2|||0.9631|0.6149|
71875247|NCT03231943|143268537|OTHER||Power model|0.7955|||||TWO_SIDED|90.0|0.6562|0.9349|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9349|0.6562|
71875248|NCT03231943|143268542|OTHER||Power model|0.737|||||TWO_SIDED|90.0|0.5649|0.9091|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2|||0.9091|0.5649|
71875249|NCT03231943|143268543|OTHER||Power model|0.7397|||||TWO_SIDED|90.0|0.5576|0.9218|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2|||0.9218|0.5576|
71875250|NCT05564299|143268544|OTHER|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum test||||0.053
71875251|NCT04124614|143268570|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-5.59||||0.0007|TWO_SIDED|95.0|-8.79|-2.38|||MMRM|||||-2.38|-8.79|0.0007
71875252|NCT04124614|143268571|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-0.47||||0.0019|TWO_SIDED|95.0|-0.76|-0.17|||MMRM|||||-0.17|-0.76|0.0019
71875253|NCT04124614|143268572|SUPERIORITY|MMRM method with model terms: treatment, (pooled) study center, previous pharmacological treatment intervention for PTSD (yes/no), visit, treatment by visit and baseline by visit interaction.|Treatment Difference|-12.03||||0.0016|TWO_SIDED|95.0|-19.44|-4.62|||MMRM|||||-4.62|-19.44|0.0016
71875254|NCT02021292|143268624|SUPERIORITY||ratio of geometric means|0.84||||0.041|TWO_SIDED|95.0|0.7|0.99|||ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.||0.99|0.70|0.0410
71916498|NCT00815776|143354573|NON_INFERIORITY_OR_EQUIVALENCE|Safety analyses were performed on the ITT population.||||||0.688|||||||t-test, 1 sided|||Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.||||0.688
71916499|NCT00815776|143354574|SUPERIORITY_OR_OTHER|||||||0.2995||||||From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.|t-test, 2 sided|||A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.||||.2995
71916500|NCT04228445|143354576|SUPERIORITY||Odds Ratio (OR)|14.041|||<|0.0001|TWO_SIDED|95.0|7.394|26.662|||Score statistics for Type 3 GEE analysis|||||26.662|7.394|<0.0001
71916501|NCT04228445|143354576|SUPERIORITY||Odds Ratio (OR)|16.772|||<|0.0001|TWO_SIDED|95.0|8.625|32.617|||Score statistics for Type 3 GEE analysis|||||32.617|8.625|<0.0001
71916502|NCT04228445|143354577|OTHER||Percentage of Responders|87.8|||||TWO_SIDED|95.0|78.6|96.9|||||Missing data imputed as non-responder|||96.9|78.6|
71916503|NCT04228445|143354577|OTHER||Percentage of Responders|87.2|||||TWO_SIDED|95.0|77.7|96.8|||||Missing data imputed as non-responder|||96.8|77.7|
71916504|NCT04228445|143354578|OTHER||percentage of satisfaction|89.8|||||TWO_SIDED|95.0|78.2|95.6||||||||95.6|78.2|
71916505|NCT04228445|143354578|OTHER||percentage of satisfaction|80.9|||||TWO_SIDED|95.0|67.5|89.6||||||||89.6|67.5|
71916506|NCT04228445|143354579|OTHER||median time to visualization (minutes)|6.0|||||TWO_SIDED|95.0|5.25|7.0||||||||7.00|5.25|
71916507|NCT04228445|143354579|OTHER||median time to visualization (minutes)|5.93|||||TWO_SIDED|95.0|5.12|7.0||||||||7.00|5.12|
71916508|NCT04228445|143354580|SUPERIORITY||Odds Ratio (OR)|19.532|||<|0.0001|TWO_SIDED|95.0|8.738|43.663|||Score statistics for Type 3 GEE analysis|||||43.663|8.738|<0.0001
71916509|NCT04228445|143354580|SUPERIORITY||Odds Ratio (OR)|15.73|||<|0.0001|TWO_SIDED|95.0|7.199|34.369|||Score statistics for Type 3 GEE analysis|||||34.369|7.199|<0.0001
71916510|NCT04228445|143354581|OTHER||Percentage of Agreement|91.1|||||TWO_SIDED|||||||||Left Ureter||||
71916511|NCT04228445|143354581|OTHER||Percentage of Agreement|88.4|||||TWO_SIDED|||||||||Left Ureter||||
71916512|NCT04228445|143354581|OTHER||Percentage of Agreement|76.1|||||TWO_SIDED|||||||||Left Ureter||||
71916513|NCT04228445|143354581|OTHER||Percentage of Agreement|95.6|||||TWO_SIDED|||||||||Right Ureter||||
71916514|NCT04228445|143354581|OTHER||Percentage of Agreement|86.0|||||TWO_SIDED|||||||||Right Ureter||||
71875255|NCT02021292|143268625|SUPERIORITY||least squares (LS) mean difference|34.04||||0.0326|TWO_SIDED|95.0|2.9|65.2||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline in 6MWD at Week 24 is the same in the placebo and the macitentan group. Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||65.2|2.9|0.0326
71916515|NCT04228445|143354581|OTHER||Percentage of Agreement|71.6|||||TWO_SIDED|||||||||Right Ureter||||
71875256|NCT02021292|143268626|SUPERIORITY||least squares (LS) mean difference|-0.39||||0.3492|TWO_SIDED|95.0|-1.21|0.43||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is that the mean change from baseline is the same in the placebo and the macitentan group. Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model.||0.43|-1.21|0.3492
71875257|NCT02021292|143268627|SUPERIORITY||Odds Ratio (OR)|0.212||||0.0962|TWO_SIDED|95.0|0.001|1.464||To control multiplicity across all endpoints, secondary endpoints were analyzed in sequence using hierarchical approach based on order and significance as pre-specified in protocol eliminating further adjustment for multiple comparisons.|ANCOVA|||The null hypothesis is the odds of worsening are the same in the placebo and the macitentan group. Logistic regression is used for Treatment Group vs. Placebo comparison to generate odds ratio, confidence levels, and p-values with treatment and WHO functional class at baseline as factors in the model.||1.464|0.001|0.0962
71875258|NCT02021292|143268628|SUPERIORITY||Model-adjusted geometric mean ratio|0.81||||0.0098|TWO_SIDED|95.0|0.7|0.95||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis (ANCOVA) was applied, including 13 subjects with corrected hemodynamic values.||0.95|0.70|0.0098
71875259|NCT02021292|143268629|SUPERIORITY||Model-adjusted geometric mean ratio|0.79||||0.0061|TWO_SIDED|95.0|0.68|0.93||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.93|0.68|0.0061
71875260|NCT02021292|143268630|SUPERIORITY||Geometric mean ratio|0.85||||0.0414|TWO_SIDED|95.0|0.73|0.99||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||||0.99|0.73|0.0414
71875261|NCT02021292|143268631|SUPERIORITY||least squares (LS) mean difference|37.19||||0.0468|TWO_SIDED|95.0|0.54|73.83||This is the post-hoc analysis and p-value is an exploratory p-value.|ANCOVA|Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.||||73.83|0.54|0.0468
71875262|NCT03865940|143268645|SUPERIORITY|||||||0.374|TWO_SIDED|95.0||||P-values less than 0.05 considered significant.|Regression, Cox|Testing null hypothesis that guanfacine has no effect on time from injection to return to baseline.||||||0.374
71875263|NCT03865940|143268646|SUPERIORITY||||||<|0.001||||||P-values less than 0.05 considered significant.|Regression, Logistic|Analysis adjusted for pre-injection score and accounted for repeated measures. Effect of study drug was tested using a four degree-of-freedom test.||||||<0.001
71875264|NCT03865940|143268647|SUPERIORITY|||||||0.775|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.775
71875265|NCT03865940|143268648|SUPERIORITY|||||||0.099|||||||Regression, Linear|The analysis adjusted for pre-injection score and accounted for repeat measures.The results of the analyses tested using a two degree-of-freedom test.||||||0.099
71875266|NCT03865940|143268649|SUPERIORITY|||||||0.907|||||||Proportional Odds Regression|The analysis was not adjusted for baseline factors.||||||0.907
71875267|NCT03865940|143268650|SUPERIORITY|||||||0.373|||||||Regression, Logistic|Adjusted for use of pain medication at baseline||||||0.373
71875268|NCT02366728|143268691|OTHER|||||||0.072|||||||Log Rank|||||||0.072
71875269|NCT02366728|143268691|OTHER|||||||0.089|||||||Log Rank|||||||0.089
71875270|NCT02366728|143268692|OTHER|||||||0.0195|||||||Wilcoxon (Mann-Whitney)|||||||0.0195
71875271|NCT02366728|143268693|OTHER|||||||0.4|||||||Log Rank|||||||0.40
71875272|NCT02366728|143268694|OTHER|||||||0.4|||||||Log Rank|||||||0.40
71875273|NCT02366728|143268695|OTHER|||||||0.16|||||||Log Rank|||||||0.16
71875274|NCT02366728|143268695|OTHER|||||||0.078|||||||Log Rank|||||||0.078
71875275|NCT02366728|143268696|OTHER|||||||0.64|||||||Log Rank|||||||0.64
71875276|NCT02366728|143268697|OTHER|||||||0.29|||||||Log Rank|||||||0.29
71875277|NCT00992511|143268700|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.06|||||TWO_SIDED|95.0|0.77|1.46||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.46|0.77|
71875278|NCT00992511|143268700|NON_INFERIORITY|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.17|||||TWO_SIDED|95.0|0.86|1.61||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition \[HI\] antibody geometric mean titres \[GMTs\]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.||1.61|0.86|
71916516|NCT04228445|143354582|SUPERIORITY||Odds Ratio (OR)|0.771||||0.4595|TWO_SIDED|95.0|0.388|1.534|||Score statistics for Type 3 GEE analysis|||||1.534|.388|0.4595
71875279|NCT04498169|143268718|SUPERIORITY|With a sample size of up-to 20 subjects within a treatment group, the study had 80% power to demonstrate a statistically significant mean change from baseline, assuming the true effect size (mean change / SD) was 0.577 or larger (e.g. assuming the true mean change from baseline was 34.6 μm and the SD was 60 μm), a one sample t-test and a two-sided alpha = 0.10.||||||0.0021|||||||One-sample t-test (within group)|||The primary analysis used the mITT population with available data per subject at eye level (ie., ODO). Robustness analyses was also performed based on the MI methodology under different assumptions of missingness and intercurrent events (where missing data or withdrawal due to lack of efficacy or AEs were imputed using FCS regression method and missing data for all other reasons were imputed using worst within subject observation prior to the intercurrent event).||||0.0021
71875280|NCT01621230|143268739|OTHER|The median (first and third quartile) lengths of the second stage of labor were estimated at 28min (15, 58) in women without epidural analgesia. Assuming a one-third increase in the length of the second stage to 37min due to epidural bupivacaine, a sample size of 155 per arm (310 total) was required for 80% power to detect such a difference using a two-sided Wilcoxon rank sum test.||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71875281|NCT01621230|143268742|OTHER|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||||||.55
71875282|NCT01621230|143268743|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||.57
71875283|NCT02993523|143268745|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.465|0.723||Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|Log Rank||HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).|||0.723|0.465|<0.001
71875284|NCT02993523|143268746|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).||||||<0.001
71875285|NCT03694418|143268754|OTHER||Incident Rate Ratio|1.73|STANDARD_DEVIATION|0.35|<|0.05|TWO_SIDED|95.0|1.02|2.95|||Wilcoxon (Mann-Whitney)|||||2.95|1.02|<0.05
71875286|NCT00809523|143268768|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|||Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.||||0.007
71875287|NCT00809523|143268769|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||t-test, 2 sided|||||||0.014
71875288|NCT04722250|143268770|NON_INFERIORITY|The endpoint is designed to test whether the Medtronic SE TAV is non-inferior to Edwards BE TAV in the composite event rate of all-cause mortality, disabling stroke or heart failure rehospitalization at 12 months post-procedure with an absolute non-inferiority margin of 8.0%.|Risk Difference (RD)|-1.2|||<|0.001|TWO_SIDED|90.0|-4.9|2.5|||z-test on Kaplan-Meier percentages|||||2.5|-4.9|<0.001
71875289|NCT04722250|143268771|SUPERIORITY||Risk Difference (RD)|-32.2|||<|0.001|TWO_SIDED|95.0|-38.7|-25.6|||z-test on Kaplan-Meier percentages|||||-25.6|-38.7|<0.001
71875290|NCT01009554|143268795|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.126|STANDARD_ERROR_OF_MEAN|0.0905||0.168|TWO_SIDED|95.0|-0.054|0.306||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.306|-0.054|0.168
71875291|NCT01009554|143268797|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.006|STANDARD_ERROR_OF_MEAN|0.067||0.928|TWO_SIDED|95.0|-0.127|0.139||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.139|-0.127|0.928
71875292|NCT01009554|143268798|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.235|STANDARD_ERROR_OF_MEAN|0.0718||0.002|TWO_SIDED|95.0|0.092|0.378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.378|0.092|0.002
71875293|NCT01009554|143268799|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.041|STANDARD_ERROR_OF_MEAN|0.1235||0.741|TWO_SIDED|95.0|-0.205|0.286||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.286|-0.205|0.741
71875294|NCT01009554|143268800|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.161|STANDARD_ERROR_OF_MEAN|0.1386||0.249|TWO_SIDED|95.0|-0.437|0.115||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.115|-0.437|0.249
71875295|NCT01009554|143268801|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.201|STANDARD_ERROR_OF_MEAN|0.1398||0.154|TWO_SIDED|95.0|-0.479|0.077||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.077|-0.479|0.154
71916517|NCT04228445|143354583|SUPERIORITY||Odds Ratio (OR)|1.036||||0.922|TWO_SIDED|95.0|0.509|2.11|||Score statistics for Type 3 GEE analysis|||||2.110|.509|0.9220
71916518|NCT02583360|143354584|SUPERIORITY|||||||0.008|||||||Chi-squared|||||||0.008
71916519|NCT02583360|143354585|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||||||0.907
71916520|NCT02583360|143354586|SUPERIORITY|||||||0.592|||||||t-test, 2 sided|||||||0.592
71916521|NCT02858713|143354611|SUPERIORITY||Odds Ratio (OR)|2.99|||=|0.004|TWO_SIDED|95.0|1.42|6.28|||Regression, Logistic|||||6.28|1.42|=0.004
71916522|NCT02858713|143354612|SUPERIORITY||Coefficient|-0.415|||=|0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change baseline to week 4||0.939|-1.770|=0.545
71916523|NCT02858713|143354612|SUPERIORITY||Coefficient|-0.415||||0.545|TWO_SIDED|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change from baseline to week 4||0.939|-1.770|0.545
71684000|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal appearance dissatisfaction||||>0.05
71875296|NCT01009554|143268802|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.195|STANDARD_ERROR_OF_MEAN|0.0746||0.011|TWO_SIDED|95.0|-0.343|-0.047||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.047|-0.343|0.011
71875297|NCT01009554|143268803|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.334|STANDARD_ERROR_OF_MEAN|0.0703|<|0.001|TWO_SIDED|95.0|-0.474|-0.195||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.195|-0.474|<0.001
71875298|NCT01009554|143268804|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.214|STANDARD_ERROR_OF_MEAN|0.0939||0.025|TWO_SIDED|95.0|-0.401|-0.027||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.027|-0.401|0.025
71875299|NCT01009554|143268805|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.056|STANDARD_ERROR_OF_MEAN|0.0562||0.319|TWO_SIDED|95.0|-0.055|0.168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.168|-0.055|0.319
71875300|NCT01009554|143268806|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.272|STANDARD_ERROR_OF_MEAN|0.0668|<|0.001|TWO_SIDED|95.0|0.139|0.405||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.405|0.139|<0.001
71916524|NCT02858713|143354612|SUPERIORITY||Coefficient|-0.581||||0.45|TWO_SIDED|95.0|-2.099|0.938|||Regression, Linear|||DLQI: Change from baseline to week 8||0.938|-2.099|0.450
71916525|NCT02858713|143354612|SUPERIORITY||Coefficient|-0.77||||0.348|TWO_SIDED|95.0|-2.389|0.848|||Regression, Linear|||DLQI: Change from baseline to week 26||0.848|-2.389|0.348
71916526|NCT02858713|143354613|SUPERIORITY||coefficient|0.4||||0.047|TWO_SIDED|95.0|0.005|0.795|||Regression, Linear|||LS-PGA: Change from baseline to week 4||0.795|0.005|0.047
71916527|NCT02858713|143354613|SUPERIORITY||Coefficient|0.091||||0.662|TWO_SIDED|95.0|-0.321|0.504|||Regression, Linear|||LS-PGA: Change from baseline to week 8||0.504|-0.321|0.662
71916528|NCT02858713|143354613|SUPERIORITY||Coefficient|0.18||||0.424|TWO_SIDED|95.0|-0.264|0.625|||Regression, Linear|||LS-PGA: Change from baseline to week 26||0.625|-0.264|0.424
71916529|NCT00126425|143354617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.83||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.83|0.23|=0.004
71916530|NCT00126425|143354617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
71916531|NCT00126425|143354617|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||=|0.004|TWO_SIDED|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||"Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time t was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."||0.84|0.23|=0.004
71916532|NCT01316380|143354633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.036||0.0005||95.0|0.057|0.199||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.199|0.057|0.0005
71916533|NCT01316380|143354633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.088|0.23||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.230|0.088|<0.0001
71875301|NCT01009554|143268807|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.398|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|0.231|0.565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.565|0.231|<0.001
71875302|NCT01009554|143268808|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.0271||0.27|TWO_SIDED|95.0|-0.024|0.084||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.084|-0.024|0.270
71875303|NCT01009554|143268809|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.0324|<|0.001|TWO_SIDED|95.0|0.073|0.202||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.202|0.073|<0.001
71916534|NCT01316380|143354634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|STANDARD_ERROR_OF_MEAN|0.037||0.001||95.0|0.049|0.194||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.194|0.049|0.001
71916535|NCT01316380|143354634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.037||0.0028||95.0|0.038|0.182||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.182|0.038|0.0028
71916536|NCT01316380|143354635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.042||0.1714||95.0|-0.025|0.14||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.140|-0.025|0.1714
71916537|NCT01316380|143354635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.042||0.0119||95.0|0.023|0.188||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.188|0.023|0.0119
71916538|NCT01316380|143354636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.034||0.0003||95.0|0.058|0.192||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.192|0.058|0.0003
71916539|NCT01316380|143354636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.149|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.082|0.216||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.216|0.082|<0.0001
71916540|NCT01316380|143354637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|STANDARD_ERROR_OF_MEAN|0.039||0.1182||95.0|-0.016|0.138||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.138|-0.016|0.1182
71916541|NCT01316380|143354637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.039||0.0102||95.0|0.024|0.178||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment\*visit and baseline\*visit.|||0.178|0.024|0.0102
71916542|NCT01316380|143354639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25||||0.2155||95.0|0.03|2.24||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||2.24|0.03|0.2155
71916543|NCT01316380|143354639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.53||||0.5071||95.0|0.43|5.44||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.||5.44|0.43|0.5071
71916544|NCT01316380|143354640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.1217||95.0|0.29|1.16||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc).||1.16|0.29|0.1217
71916545|NCT01316380|143354640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.8974||95.0|0.53|1.75||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc). The Hazard Ratio is still estimable from the Cox model.||1.75|0.53|0.8974
71916546|NCT01316380|143354641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.222|STANDARD_ERROR_OF_MEAN|0.129||0.0872|TWO_SIDED|95.0|-0.032|0.476||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.476|-0.032|0.0872
71684001|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal appearance dissatisfaction scores||||>0.05
71916547|NCT01316380|143354641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.033|STANDARD_ERROR_OF_MEAN|0.129||0.7995|TWO_SIDED|95.0|-0.287|0.221||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.221|-0.287|0.7995
71916548|NCT01316380|143354642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.097|STANDARD_ERROR_OF_MEAN|0.076||0.2038|TWO_SIDED|95.0|-0.053|0.247||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.||0.247|-0.053|0.2038
71916549|NCT01316380|143354642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009|STANDARD_ERROR_OF_MEAN|0.076||0.9104|TWO_SIDED|95.0|-0.158|0.141||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.141|-0.158|0.9104
71875304|NCT01009554|143268810|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0399|<|0.001|TWO_SIDED|95.0|0.114|0.273||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.273|0.114|<0.001
71875305|NCT01009554|143268811|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0273||0.217|TWO_SIDED|95.0|-0.02|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|-0.020|0.217
71875306|NCT01009554|143268812|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.137|STANDARD_ERROR_OF_MEAN|0.032|<|0.001|TWO_SIDED|95.0|0.073|0.2||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.200|0.073|<0.001
71875307|NCT01009554|143268813|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.195|STANDARD_ERROR_OF_MEAN|0.0406|<|0.001|TWO_SIDED|95.0|0.114|0.276||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.276|0.114|<0.001
71875308|NCT01009554|143268814|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0716||0.444|TWO_SIDED|95.0|-0.087|0.197||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.197|-0.087|0.444
71875309|NCT01009554|143268815|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.349|STANDARD_ERROR_OF_MEAN|0.0843|<|0.001|TWO_SIDED|95.0|0.182|0.517||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.517|0.182|<0.001
71875310|NCT01009554|143268816|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.542|STANDARD_ERROR_OF_MEAN|0.1063|<|0.001|TWO_SIDED|95.0|0.331|0.754||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.754|0.331|<0.001
71875311|NCT01009554|143268817|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.032|STANDARD_ERROR_OF_MEAN|0.0344||0.361|TWO_SIDED|95.0|-0.037|0.1||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.100|-0.037|0.361
71875312|NCT01009554|143268818|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.174|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.092|0.256||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.256|0.092|<0.001
71875313|NCT01009554|143268819|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.264|STANDARD_ERROR_OF_MEAN|0.0504|<|0.001|TWO_SIDED|95.0|0.164|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.164|<0.001
71875314|NCT01009554|143268820|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.034|STANDARD_ERROR_OF_MEAN|0.0345||0.331|TWO_SIDED|95.0|-0.035|0.102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.102|-0.035|0.331
71875315|NCT01009554|143268821|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.177|STANDARD_ERROR_OF_MEAN|0.0414|<|0.001|TWO_SIDED|95.0|0.095|0.259||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.259|0.095|<0.001
71875316|NCT01009554|143268822|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.265|STANDARD_ERROR_OF_MEAN|0.0519|<|0.001|TWO_SIDED|95.0|0.162|0.368||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.368|0.162|<0.001
71875317|NCT01009554|143268823|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.138|STANDARD_ERROR_OF_MEAN|0.0726||0.06|TWO_SIDED|95.0|-0.006|0.282||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.282|-0.006|0.060
71875318|NCT01009554|143268824|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.338|STANDARD_ERROR_OF_MEAN|0.087|<|0.001|TWO_SIDED|95.0|0.165|0.51||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.510|0.165|<0.001
71875319|NCT01009554|143268825|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.394|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.176|0.612||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.612|0.176|<0.001
71875320|NCT01009554|143268826|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.072|STANDARD_ERROR_OF_MEAN|0.0355||0.045|TWO_SIDED|95.0|0.002|0.143||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.143|0.002|0.045
71875321|NCT01009554|143268827|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.178|STANDARD_ERROR_OF_MEAN|0.0415|<|0.001|TWO_SIDED|95.0|0.095|0.26||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.260|0.095|<0.001
71875322|NCT01009554|143268828|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.052|<|0.001|TWO_SIDED|95.0|0.094|0.3||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.300|0.094|<0.001
71875323|NCT01009554|143268829|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.077|STANDARD_ERROR_OF_MEAN|0.0355||0.034|TWO_SIDED|95.0|0.006|0.147||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.147|0.006|0.034
71875324|NCT01009554|143268830|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0398|<|0.001|TWO_SIDED|95.0|0.089|0.247||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.247|0.089|<0.001
71875325|NCT01009554|143268831|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.193|STANDARD_ERROR_OF_MEAN|0.0516|<|0.001|TWO_SIDED|95.0|0.091|0.296||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.296|0.091|<0.001
71875326|NCT01009554|143268832|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.031||0.524|TWO_SIDED|95.0|-0.082|0.042||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.042|-0.082|0.524
71875327|NCT01009554|143268833|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.055|STANDARD_ERROR_OF_MEAN|0.0395||0.172|TWO_SIDED|95.0|-0.024|0.133||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.133|-0.024|0.172
71875328|NCT01009554|143268834|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.116|STANDARD_ERROR_OF_MEAN|0.0439||0.01|TWO_SIDED|95.0|0.028|0.203||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.203|0.028|0.010
71916550|NCT01316380|143354643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.131|STANDARD_ERROR_OF_MEAN|0.068||0.0559|TWO_SIDED|95.0|-0.003|0.265||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.265|-0.003|0.0559
71916551|NCT01316380|143354643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.068||0.8795|TWO_SIDED|95.0|-0.144|0.123||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment\*week and baseline\*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.||0.123|-0.144|0.8795
71916552|NCT02332876|143354654|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71916553|NCT02614261|143354674|SUPERIORITY||LSMean Difference|-2.09|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.92|-1.26|||Mixed Models Analysis|||||-1.26|-2.92|<.001
71916554|NCT02614261|143354674|SUPERIORITY||LSMean Difference|-1.88|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|-2.71|-1.05|||Mixed Models Analysis|||||-1.05|-2.71|<.001
71916555|NCT02614261|143354675|SUPERIORITY||Odds Ratio (OR)|1.623||||0.004|TWO_SIDED|95.0|1.167|2.256|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%,||2.256|1.167|.004
71916556|NCT02614261|143354675|SUPERIORITY||Odds Ratio (OR)|1.788|||<|0.001|TWO_SIDED|95.0|1.291|2.474|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%||2.474|1.291|<.001
71916557|NCT02614261|143354675|SUPERIORITY||Odds Ratio (OR)|1.498||||0.102|TWO_SIDED|95.0|0.923|2.43|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.430|0.923|.102
71916558|NCT02614261|143354675|SUPERIORITY||Odds Ratio (OR)|1.819||||0.011|TWO_SIDED|95.0|1.146|2.888|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%||2.888|1.146|.011
71684002|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in appearance dissatisfaction||||>0.05
71875329|NCT01009554|143268835|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.014|STANDARD_ERROR_OF_MEAN|0.0145||0.348|TWO_SIDED|95.0|-0.043|0.015||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.015|-0.043|0.348
71875330|NCT01009554|143268836|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.025|STANDARD_ERROR_OF_MEAN|0.0186||0.185|TWO_SIDED|95.0|-0.012|0.062||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.062|-0.012|0.185
71875331|NCT01009554|143268837|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.049|STANDARD_ERROR_OF_MEAN|0.0196||0.014|TWO_SIDED|95.0|0.01|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.088|0.010|0.014
71916559|NCT02614261|143354675|SUPERIORITY||Odds Ratio (OR)|0.761||||0.729|TWO_SIDED|95.0|0.163|3.563|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||3.563|0.163|0.729
71916560|NCT02614261|143354675|SUPERIORITY||Odds Ratio (OR)|1.897||||0.276|TWO_SIDED|95.0|0.6|5.998|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%||5.998|0.600|.276
71916561|NCT02614261|143354676|SUPERIORITY||LSMean Difference|5.06|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|2.12|7.99|||Mixed Models Analysis|||||7.99|2.12|<.001
71916562|NCT02614261|143354676|SUPERIORITY||LSMean Difference|6.29|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|3.03|9.55|||Mixed Models Analysis|||||9.55|3.03|<.001
71916563|NCT02614261|143354677|SUPERIORITY||LSMean Difference|-2.51|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-3.27|-1.76|||Mixed Models Analysis|||||-1.76|-3.27|<.001
71916564|NCT02614261|143354677|SUPERIORITY||LSMean Difference|-2.01|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.77|-1.26|||Mixed Models Analysis|||||-1.26|-2.77|<.001
71916565|NCT02614261|143354678|SUPERIORITY||LSMean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.34|0.06|||Mixed Models Analysis|||||0.06|-0.34|.181
71916566|NCT02614261|143354678|SUPERIORITY||LSMean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.1||0.006|TWO_SIDED|95.0|-0.48|-0.08|||Mixed Models Analysis|||||-0.08|-0.48|.006
71916567|NCT02614261|143354679|SUPERIORITY||LSMean Difference|-22.71|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|-31.74|-13.69|||Mixed Models Analysis|||||-13.69|-31.74|<.001
71916568|NCT02614261|143354679|SUPERIORITY||LSMean Difference|-18.09|STANDARD_ERROR_OF_MEAN|4.58|<|0.001|TWO_SIDED|95.0|-27.09|-9.09|||Mixed Models Analysis|||||-9.09|-27.09|<.001
71916569|NCT02614261|143354680|SUPERIORITY||LSMean Difference|-8.74|STANDARD_ERROR_OF_MEAN|3.9||0.025|TWO_SIDED|95.0|-16.39|-1.08|||ANCOVA|||||-1.08|-16.39|.025
71916570|NCT02614261|143354680|SUPERIORITY||LSMean Difference|-5.49|STANDARD_ERROR_OF_MEAN|3.88||0.157|TWO_SIDED|95.0|-13.1|2.12|||ANCOVA|||||2.12|-13.10|.157
71916571|NCT02614261|143354681|SUPERIORITY|||||||0.263|||||||Cochran-Mantel-Haenszel|||||||.263
71916572|NCT02614261|143354681|SUPERIORITY|||||||0.29|||||||Cochran-Mantel-Haenszel|||||||.290
71916573|NCT01307046|143354710|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-5.1|||<|0.001|TWO_SIDED|95.0|-6.8|-3.4|||constrained longitudinal data analysis|||||-3.4|-6.8|<.001
71916574|NCT01307046|143354711|SUPERIORITY_OR_OTHER_LEGACY||Difference in least square means|-9.2|||<|0.001|TWO_SIDED|95.0|-11.9|-6.5|||constrained longitudinal data analysis|||||-6.5|-11.9|<.001
71916575|NCT02574520|143354722|SUPERIORITY|Primary|Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.24||0.124|TWO_SIDED|95.0|-0.84|0.1|||ANOVA|Mixed model with repeated measures (MMRM) for scheduled pain measurements was estimated with time as a repeating factor within subject.|Least squares mean from the MMRM described in the Statistical Test of Hypothesis.|Pain Intensity on Movement 0-48 hr||0.10|-0.84|0.124
71916576|NCT04964557|143354760|SUPERIORITY||Mean Difference (Final Values)|-62.3|||<|0.001|TWO_SIDED|95.0|-68.0|-56.6|||ANCOVA|||||-56.6|-68|<0.001
71916577|NCT04964557|143354761|SUPERIORITY||Mean Difference (Final Values)|-76.7|||<|0.001|TWO_SIDED|95.0|-81.7|-71.7|||ANCOVA|||||-71.7|-81.7|<0.001
71916578|NCT03793010|143354776|SUPERIORITY||Mean Difference (Final Values)|0.31|||||TWO_SIDED|95.0|-1.2|1.81||||||||1.81|-1.20|
71916579|NCT03793010|143354777|SUPERIORITY||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-1.05|2.24||||||||2.24|-1.05|
71916580|NCT03793010|143354778|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|0.9||||||||0.9|-1.0|
71916581|NCT05032755|143354831|SUPERIORITY||beta estimate|1.902|STANDARD_ERROR_OF_MEAN|0.398|<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term|||||<.0001
71916582|NCT05032755|143354832|SUPERIORITY||beta estimate|0.368|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||<.0001
71875332|NCT01009554|143268838|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.016||0.623|TWO_SIDED|95.0|-0.04|0.024||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.024|-0.040|0.623
71875333|NCT01009554|143268839|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.024|STANDARD_ERROR_OF_MEAN|0.0186||0.192|TWO_SIDED|95.0|-0.013|0.061||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.061|-0.013|0.192
71875334|NCT01009554|143268840|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.057|STANDARD_ERROR_OF_MEAN|0.0213||0.009|TWO_SIDED|95.0|0.014|0.099||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.099|0.014|0.009
71875335|NCT01009554|143268841|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.0384||0.893|TWO_SIDED|95.0|-0.081|0.071||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.071|-0.081|0.893
71916583|NCT05032755|143354833|SUPERIORITY||beta estimate|0.672|STANDARD_ERROR_OF_MEAN|0.362||0.065|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.065
71916584|NCT05032755|143354834|SUPERIORITY||beta estimate|0.364|STANDARD_ERROR_OF_MEAN|0.133||0.007|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.007
71875336|NCT01009554|143268842|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.021|STANDARD_ERROR_OF_MEAN|0.0476||0.655|TWO_SIDED|95.0|-0.073|0.116||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.116|-0.073|0.655
71875337|NCT01009554|143268843|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.222|STANDARD_ERROR_OF_MEAN|0.0693||0.002|TWO_SIDED|95.0|0.084|0.359||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.359|0.084|0.002
71875338|NCT01009554|143268844|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.002|STANDARD_ERROR_OF_MEAN|0.0187||0.914|TWO_SIDED|95.0|-0.039|0.035||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.035|-0.039|0.914
71875339|NCT01009554|143268845|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0229||0.646|TWO_SIDED|95.0|-0.035|0.056||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.056|-0.035|0.646
71916585|NCT05032755|143354835|SUPERIORITY||beta estimate|1.78|STANDARD_ERROR_OF_MEAN|1.78||0.325|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.325
71916586|NCT05032755|143354837|SUPERIORITY||beta estimate|0.222|STANDARD_ERROR_OF_MEAN|0.104||0.035|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.035
71916587|NCT05032755|143354838|SUPERIORITY||beta estimate|0.201|STANDARD_ERROR_OF_MEAN|0.181||0.27|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.27
71916588|NCT05032755|143354839|SUPERIORITY||beta estimate|-1.229|STANDARD_ERROR_OF_MEAN|1.037||0.24|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 5 levels. Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.24
71916589|NCT05032755|143354844|SUPERIORITY||beta estimate|4.69|STANDARD_ERROR_OF_MEAN|2.88||0.113|TWO_SIDED|||||Group is entered as a between-subjects factor and Visit is included as a repeated factor with 2 levels (pre- vs post-intervention). Baseline pain and FTCD scores, assessed at screening, are included along with sex as covariates.|Mixed Models Analysis|Model includes random intercepts|Estimation parameter is beta estimate for group by visit interaction term.|||||0.113
71916590|NCT01874353|143354855|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.22|<0.0001
71875340|NCT01009554|143268846|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.102|STANDARD_ERROR_OF_MEAN|0.0309||0.001|TWO_SIDED|95.0|0.04|0.163||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.163|0.040|0.001
71916591|NCT01874353|143354855|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||||TWO_SIDED|95.0|0.17|1.19||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.19|0.17|
71916592|NCT01874353|143354856|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0537|TWO_SIDED|95.0|0.54|1.0||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \<1 favours olaparib|||1.00|0.54|0.0537
71916593|NCT01874353|143354856|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.38|2.49||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||2.49|0.38|
71875341|NCT01009554|143268847|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0179||0.93|TWO_SIDED|95.0|-0.034|0.037||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.037|-0.034|0.930
71875342|NCT01009554|143268848|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.016|STANDARD_ERROR_OF_MEAN|0.0224||0.486|TWO_SIDED|95.0|-0.029|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.060|-0.029|0.486
71875343|NCT01009554|143268849|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.112|STANDARD_ERROR_OF_MEAN|0.0338||0.001|TWO_SIDED|95.0|0.045|0.18||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.180|0.045|0.001
71875344|NCT01009554|143268850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.1006||0.237|TWO_SIDED|95.0|-0.08|0.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.320|-0.080|0.237
71875345|NCT01009554|143268851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.112|<|0.001|TWO_SIDED|95.0|0.298|0.743||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.743|0.298|<0.001
71875346|NCT01009554|143268852|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.567|STANDARD_ERROR_OF_MEAN|0.1367|<|0.001|TWO_SIDED|95.0|0.295|0.839||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.839|0.295|<0.001
71875347|NCT01009554|143268853|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0491||0.21|TWO_SIDED|95.0|-0.036|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.160|-0.036|0.210
71875348|NCT01009554|143268854|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|0.153|0.372||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.372|0.153|<0.001
71916594|NCT01874353|143354857|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.41|0.23|<0.0001
71875349|NCT01009554|143268855|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.281|STANDARD_ERROR_OF_MEAN|0.0654|<|0.001|TWO_SIDED|95.0|0.151|0.411||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.411|0.151|<0.001
71875350|NCT01009554|143268856|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.066|STANDARD_ERROR_OF_MEAN|0.0496||0.187|TWO_SIDED|95.0|-0.033|0.165||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.165|-0.033|0.187
71875351|NCT01009554|143268857|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.256|STANDARD_ERROR_OF_MEAN|0.0544|<|0.001|TWO_SIDED|95.0|0.148|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.364|0.148|<0.001
71875352|NCT01009554|143268858|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.273|STANDARD_ERROR_OF_MEAN|0.0669|<|0.001|TWO_SIDED|95.0|0.14|0.406||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||0.406|0.140|<0.001
71875353|NCT01405937|143268864|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
71875354|NCT01405937|143268864|SUPERIORITY_OR_OTHER||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.||||<0.001
71875355|NCT02673619|143268928|OTHER||Percentage difference|25.0|||||TWO_SIDED|90.0|-21.1|75.1||||||||75.1|-21.1|
71875356|NCT02673619|143268928|OTHER||Percentage difference|25.5|||||TWO_SIDED|90.0|-10.2|59.2||||||||59.2|-10.2|
71875357|NCT02673619|143268929|OTHER||Percentage Difference|-16.2|||||TWO_SIDED|90.0|-59.7|32.0||||||||32.0|-59.7|
71875358|NCT02673619|143268929|OTHER||Percentage Difference|18.0|||||TWO_SIDED|90.0|-18.8|52.1||||||||52.1|-18.8|
71875359|NCT02673619|143268933|OTHER||Percentage Difference|16.2|||||TWO_SIDED|90.0|-32.0|59.7||||||||59.7|-32.0|
71875360|NCT02673619|143268933|OTHER||Percentage Difference|7.5|||||TWO_SIDED|90.0|-27.7|42.3||||||||42.3|-27.7|
71875361|NCT02960113|143268975|OTHER|||||||0.98||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing nausea equal between groups||||0.98
71875362|NCT02960113|143268976|OTHER|||||||0.9||||||Bonferroni-adjusted P-value, calculated as two times the nominal p-value because there are two primary outcomes|Chi-squared|d.f.=2||Null hypothesis: Percent experiencing vomiting equal across groups||||0.90
71875363|NCT02960113|143268977|OTHER|Null hypothesis: Mean scores equal across treatment groups||||||0.026|||||||ANOVA|||||||0.026
71916595|NCT01874353|143354857|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41|||||TWO_SIDED|95.0|0.18|1.03||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \<1 favours olaparib|||1.03|0.18|
71875364|NCT02960113|143268978|OTHER|Null hypothesis: means equal across treatment groups||||||0.91|||||||ANOVA|||||||0.91
71875365|NCT02960113|143268979|OTHER|||||||0.8|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.80
71875366|NCT02960113|143268980|OTHER|||||||0.82|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.82
71875367|NCT02960113|143268981|OTHER|||||||0.93|||||||ANOVA|||Null hypothesis: means equal across treatment groups||||0.93
71875368|NCT02960113|143268982|OTHER|Null hypothesis: percent of vomiting equal across treatment groups||||||0.55|||||||Chi-squared|d.f.=2||||||0.55
71875369|NCT02960113|143268983|OTHER|||||||0.71|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.71
71875370|NCT02960113|143268984|OTHER|||||||0.55|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.55
71875371|NCT02960113|143268985|OTHER|||||||0.2|||||||Chi-squared|d.f.=2||Null hypothesis: percent of vomiting equal across treatment groups||||0.20
71875372|NCT03434353|143268994|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-30.4|26.4|||||The percentage difference (Group 1 - Group 2) \& corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative).|||26.4|-30.4|
71875373|NCT03434353|143268994|OTHER||Percentage Difference|-24.7|||||TWO_SIDED|95.0|-49.2|-0.2|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||-0.2|-49.2|
71875374|NCT03434353|143268994|OTHER||Percentage Difference|-17.8|||||TWO_SIDED|95.0|-43.7|8.2|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||8.2|-43.7|
71684003|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in appearance dissatisfaction across time.||||>0.05
71875375|NCT03434353|143268996|OTHER||Percentage Difference|-16.6|||||TWO_SIDED|95.0|-37.7|4.4|||||The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.7|
71875376|NCT03434353|143268996|OTHER||Percentage Difference|-16.9|||||TWO_SIDED|95.0|-38.1|4.3|||||The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.3|-38.1|
71875377|NCT03434353|143268996|OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-37.9|4.4|||||The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative).|||4.4|-37.9|
71875378|NCT02464228|143269019|OTHER|||||||0|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.000
71875379|NCT02464228|143269019|OTHER|||||||1|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
71875380|NCT02464228|143269019|OTHER|||||||0.026|||||||Wilson approximation|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||0.026
71875381|NCT02464228|143269019|OTHER|||||||1|||||||Clopper-Pearson method|||Null hypothesis H0: PORR = 10% versus HA: PORR \> 10% will be tested at a = 0.05 significance level using a two-sided binomial test. The choice of test statistics was driven by the method used for interval estimation.||||1.000
71875382|NCT00148954|143269045|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.34||||0.003|TWO_SIDED|95.0|1.11|1.62|||Regression, Cox|||||1.62|1.11|0.003
71875383|NCT02022085|143269087|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||PTA4 6 months with Baha Attract vs Unaided||||<0.0001
71875384|NCT02022085|143269087|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 12 months with Baha Attract vs Unaided||||<0.0001
71875385|NCT02022085|143269087|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 24 months with Baha Attract vs Unaided||||<0.0001
71875386|NCT02022085|143269088|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 24 months vs Unaided situation Pre-Op||||<0.0001
71875387|NCT02022085|143269089|SUPERIORITY_OR_OTHER||||||<|0.0001||||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 12 months vs Unaided situation Pre-Op||||<0.0001
71875388|NCT02022085|143269090|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||All comparisons to the Unaided situation were p=\<0.0001.|Fisher's non-parametric permutation test|||Baha Attract after 6 months vs Unaided situation Pre-Op||||<0.0001
71916596|NCT01874353|143354858|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5||||0.0002|TWO_SIDED|95.0|0.34|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.72|0.34|0.0002
71875389|NCT02022085|143269091|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech in Noise, 6 months Baha Attract vs Unaided||||<0.0001
71875390|NCT02022085|143269091|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 12 months Baha Attract vs Unaided||||<0.0001
71875391|NCT02022085|143269091|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in Noise, 24 months Baha Attract vs Unaided||||<0.0001
71875392|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 50dB||||<0.0001
71875393|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 65dB||||<0.0001
71875394|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Speech in quiet at 80dB||||<0.0001
71875395|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 50dB||||<0.0001
71875396|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 65dB||||<0.0001
71875397|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||12 months: Speech in quiet at 80dB||||<0.0001
71875398|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 50dB||||<0.0001
71875399|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 65dB||||<0.0001
71875400|NCT02022085|143269092|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||24 months: Speech in quiet at 80dB||||<0.0001
71875401|NCT02022085|143269093|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months with Baha Attract vs Softband: change in PTA4||||0.38
71684004|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on appearance dissatisfaction||||>0.05
71875402|NCT02022085|143269093|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||12 months with Baha Attract vs Softband: change in PTA4||||0.84
71875403|NCT02022085|143269093|SUPERIORITY_OR_OTHER|||||||0.89|||||||Fisher's non-parametric permutation test|||24 months with Baha Attract vs Softband: change in PTA4||||0.89
71875404|NCT02022085|143269094|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||250Hz: 6 months with Baha Attract vs Softband||||0.34
71875405|NCT02022085|143269094|SUPERIORITY_OR_OTHER|||||||0.0004|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||500Hz: 6 months with Baha Attract vs Softband||||0.0004
71875406|NCT02022085|143269094|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||1000Hz: 6 months with Baha Attract vs Softband||||0.22
71875407|NCT02022085|143269094|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||2000Hz: 6 months with Baha Attract vs Softband||||0.64
71875408|NCT02022085|143269094|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||3000Hz: 6 months with Baha Attract vs Softband||||0.039
71875409|NCT02022085|143269094|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||4000Hz: 6 months with Baha Attract vs Softband||||0.012
71875410|NCT02022085|143269094|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6000Hz: 6 months with Baha Attract vs Softband||||<0.0001
71875411|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.11|||||||Fisher's non-parametric permutation test|||250Hz: 12 months with Baha Attract vs Softband||||0.11
71875412|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.066|||||||Fisher's non-parametric permutation test|||500Hz: 12 months with Baha Attract vs Softband||||0.066
71875413|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.71|||||||Fisher's non-parametric permutation test|||1000Hz: 12 months with Baha Attract vs Softband||||0.71
71875414|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.78|||||||Fisher's non-parametric permutation test|||2000Hz: 12 months with Baha Attract vs Softband||||0.78
71875415|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.015|||||||Fisher's non-parametric permutation test|||3000Hz: 12 months with Baha Attract vs Softband||||0.015
71875416|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.035|||||||Fisher's non-parametric permutation test|||4000Hz: 12 months with Baha Attract vs Softband||||0.035
71875417|NCT02022085|143269095|SUPERIORITY_OR_OTHER|||||||0.0013|||||||Fisher's non-parametric permutation test|||6000Hz: 12 months with Baha Attract vs Softband||||0.0013
71875418|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||250Hz: 24 months with Baha Attract vs Softband||||0.0051
71875419|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.26|||||||Fisher's non-parametric permutation test|||500Hz: 24 months with Baha Attract vs Softband||||0.26
71875420|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.22|||||||Fisher's non-parametric permutation test|||1000Hz: 24 months with Baha Attract vs Softband||||0.22
71875421|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.57|||||||Fisher's non-parametric permutation test|||2000Hz: 24 months with Baha Attract vs Softband||||0.57
71875422|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||3000Hz: 24 months with Baha Attract vs Softband||||0.064
71875423|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.064|||||||Fisher's non-parametric permutation test|||4000Hz: 24 months with Baha Attract vs Softband||||0.064
71875424|NCT02022085|143269096|SUPERIORITY_OR_OTHER|||||||0.0051|||||||Fisher's non-parametric permutation test|||6000Hz: 24 months with Baha Attract vs Softband||||0.0051
71875425|NCT02022085|143269097|SUPERIORITY_OR_OTHER|||||||0.46|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Speech in Noise with Baha Attract vs Softband||||0.46
71875426|NCT02022085|143269097|SUPERIORITY_OR_OTHER|||||||0.19|||||||Fisher's non-parametric permutation test|||12 months: Speech in Noise with Baha Attract vs Softband||||0.19
71875427|NCT02022085|143269097|SUPERIORITY_OR_OTHER|||||||0.31|||||||Fisher's non-parametric permutation test|||24 months: Speech in Noise with Baha Attract vs Softband||||0.31
71875428|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 50dB||||0.43
71875429|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 65dB||||0.16
71875430|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months Speech in Quiet at 80dB||||0.65
71875431|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.93|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 50dB||||0.93
71875432|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.094|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 65dB||||0.094
71875433|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.44|||||||Fisher's non-parametric permutation test|||12 months Speech in Quiet at 80dB||||0.44
71875434|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.021|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 50dB||||0.021
71875435|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 65dB||||0.024
71875436|NCT02022085|143269098|SUPERIORITY_OR_OTHER|||||||0.59|||||||Fisher's non-parametric permutation test|||24 months Speech in Quiet at 80dB||||0.59
71875437|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Comprehensive health state||||0.088
71875438|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Vision||||0.88
71684005|NCT03646305|142886289|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on appearance dissatisfaction||||>0.05
71875439|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Hearing||||0.020
71875440|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.039|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Speech||||0.039
71875441|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Ambulation||||0.25
71875442|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Dexterity||||0.38
71875443|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Emotion||||0.43
71875444|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.85|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Cognition||||0.85
71875445|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months change in Pain||||0.25
71875446|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.088|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Comprehensive health state||||0.088
71875447|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.63|||||||Fisher's non-parametric permutation test|||24 months change in Vision||||0.63
71875448|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||24 months change in Hearing||||0.045
71875449|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher's non-parametric permutation test|||24 months change in Speech||||0.016
71875450|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher's non-parametric permutation test|||24 months change in Ambulation||||0.25
71875451|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxan Signed Rank Test|Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead||24 months change in Dexterity||||0.50
71875452|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.29|||||||Fisher's non-parametric permutation test|||24 months change in Emotion||||0.29
71875453|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.92|||||||Fisher's non-parametric permutation test|||24 months change in Cognition||||0.92
71875454|NCT02022085|143269099|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher's non-parametric permutation test|||24 months change in Pain||||0.020
71875455|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Ease of communication||||<0.0001
71875456|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||6 months: Background noise||||<0.0001
71875457|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Reverberation||||<0.0001
71875458|NCT02022085|143269100|SUPERIORITY_OR_OTHER|||||||0.69|||||||Fisher's non-parametric permutation test|||6 months: Aversiveness||||0.69
71875459|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||6 months: Global||||<0.0001
71875460|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Ease of communication||||<0.001
71875461|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Background noise||||<0.001
71875462|NCT02022085|143269100|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Reverberation||||<0.001
71875463|NCT02022085|143269100|SUPERIORITY_OR_OTHER|||||||0.84|||||||Fisher's non-parametric permutation test|||24 months: Aversiveness||||0.84
71875464|NCT02022085|143269100|SUPERIORITY_OR_OTHER||Fisher's non-parametric permutation test||||<|0.001|||||||Fisher's non-parametric permutation test|||24 months: Global||||<0.001
71875465|NCT02022085|143269101|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 6 months||||<0.0001
71875466|NCT02022085|143269101|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 6 months||||<0.0001
71875467|NCT02022085|143269101|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 6 months||||<0.0001
71875468|NCT02022085|143269101|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech: Change from pre-op to 24 months||||<0.0001
71875469|NCT02022085|143269101|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Spatial: Change from pre-op to 24 months||||<0.0001
71875470|NCT02022085|143269101|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Qualities: Change from pre-op to 24 months||||<0.0001
71875471|NCT00448435|143269110|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin + or - 15 L/min|Mean Difference (Net)|2.8|STANDARD_ERROR_OF_MEAN|5.91||0.6383||95.0|-9.1|14.69||Confidence Interval|Mixed Models Analysis|||Difference between treatments \[(SLM + FP)- SFC\](SE) 2.8 (5.91)||14.69|-9.10|0.6383
71875472|NCT01387230|143269124|SUPERIORITY_OR_OTHER||Least squares mean difference|0.127|||<|0.001|TWO_SIDED|95.0|0.052|0.202|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 62.5 µg minus Placebo.|||0.202|0.052|<0.001
71875473|NCT01387230|143269124|SUPERIORITY_OR_OTHER||Least squares mean difference|0.152|||<|0.001|TWO_SIDED|95.0|0.076|0.229|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 125 µg minus Placebo.|||0.229|0.076|<0.001
71875474|NCT04561765|143269136|SUPERIORITY|||||||0.051|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.051
71875475|NCT04561765|143269136|SUPERIORITY|||||||0.206|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.206
71875476|NCT04561765|143269136|SUPERIORITY|||||||0.765|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge||||0.765
71875477|NCT04561765|143269136|SUPERIORITY|||||||0.991|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at follow-up.||||0.991
71875478|NCT04561765|143269136|SUPERIORITY|||||||0.963|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.963
71875479|NCT04561765|143269136|SUPERIORITY|||||||0.916|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P values at discharge.||||0.916
71875480|NCT04561765|143269137|SUPERIORITY|||||||0.005|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.005
71875481|NCT04561765|143269137|SUPERIORITY|||||||0.27|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.270
71875482|NCT04561765|143269137|SUPERIORITY|||||||0.177|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.177
71875483|NCT04561765|143269137|SUPERIORITY|||||||0.3|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P Value at follow-up.||||0.300
71875484|NCT04561765|143269137|SUPERIORITY|||||||0.996|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.996
71875485|NCT04561765|143269137|SUPERIORITY|||||||0.334|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.334
71875486|NCT04561765|143269139|SUPERIORITY|||||||0.212|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.212
71875487|NCT04561765|143269139|SUPERIORITY|||||||0.965|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.965
71875488|NCT04561765|143269139|SUPERIORITY|||||||0.294|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.294
71875489|NCT04561765|143269139|SUPERIORITY|||||||0.207|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.207
71875490|NCT04561765|143269139|SUPERIORITY|||||||0.158|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.158
71875491|NCT04561765|143269139|SUPERIORITY|||||||0.988|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.988
71875492|NCT04561765|143269141|SUPERIORITY|||||||0.295|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.295
71875493|NCT04561765|143269141|SUPERIORITY|||||||0.718|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.718
71875494|NCT04561765|143269141|SUPERIORITY|||||||0.738|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.738
71875495|NCT04561765|143269141|SUPERIORITY|||||||0.797|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.797
71875496|NCT04561765|143269141|SUPERIORITY|||||||0.26|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.260
71875497|NCT04561765|143269141|SUPERIORITY|||||||0.616|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.616
71875498|NCT04561765|143269142|SUPERIORITY|||||||0.333|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.333
71875499|NCT04561765|143269142|SUPERIORITY|||||||0.003|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.003
71875500|NCT04561765|143269142|SUPERIORITY|||||||0.106|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.106
71875501|NCT04561765|143269142|SUPERIORITY|||||||0.541|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.541
71875502|NCT04561765|143269142|SUPERIORITY|||||||0.202|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.202
71875503|NCT04561765|143269142|SUPERIORITY|||||||0.791|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.791
71875504|NCT04561765|143269143|SUPERIORITY|||||||0.026|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.026
71875505|NCT04561765|143269143|SUPERIORITY|||||||0.15|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.15
71875506|NCT04561765|143269143|SUPERIORITY|||||||0.745|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.745
71875507|NCT04561765|143269143|SUPERIORITY|||||||0.021|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.021
71875508|NCT04561765|143269143|SUPERIORITY|||||||0.155|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.155
71875509|NCT04561765|143269143|SUPERIORITY|||||||0.652|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.652
71875510|NCT04561765|143269144|SUPERIORITY|||||||0.343|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.343
71875511|NCT04561765|143269144|SUPERIORITY|||||||0.995|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.995
71875512|NCT04561765|143269144|SUPERIORITY|||||||0.371|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at discharge.||||0.371
71875513|NCT04561765|143269144|SUPERIORITY|||||||0.228|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.228
71875514|NCT04561765|143269144|SUPERIORITY|||||||0.282|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||P value at follow-up.||||0.282
71875515|NCT04561765|143269144|SUPERIORITY|||||||0.986|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.986
71875516|NCT04561765|143269145|SUPERIORITY|||||||0.421|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.421
71875517|NCT04561765|143269145|SUPERIORITY|||||||0.556|||||||ANOVA|Reported p-values are based on Tukey's HSD post-hoc adjustment to one-way ANOVA.||||||0.556
71875518|NCT03027557|143269146|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
71875519|NCT03027557|143269147|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
71875520|NCT03027557|143269148|SUPERIORITY||||||=|0.0019|||||||ANOVA|||||||= 0.0019
71875521|NCT03027557|143269149|SUPERIORITY||||||=|0.096|||||||ANOVA|||||||= 0.096
71875522|NCT03027557|143269150|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
71875523|NCT03027557|143269151|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
71875524|NCT03027557|143269152|SUPERIORITY||||||=|0.0027|||||||ANOVA|||||||= 0.0027
71875525|NCT03027557|143269153|SUPERIORITY||||||=|0.081|||||||ANOVA|||||||= 0.081
71875526|NCT03027557|143269154|SUPERIORITY||||||=|0.0071|||||||ANOVA|||||||= 0.0071
71875527|NCT03027557|143269155|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
71875528|NCT03027557|143269156|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
71875529|NCT03027557|143269157|SUPERIORITY||||||=|0.38|||||||Kruskal-Wallis|||||||= 0.38
71875530|NCT03027557|143269162|SUPERIORITY||||||=|0.83|||||||Kruskal-Wallis|||||||= 0.83
71875531|NCT03027557|143269165|SUPERIORITY||||||>|0.05|||||||ANOVA|||||||>0.05
71875532|NCT03027557|143269166|SUPERIORITY||||||=|0.0077|||||||ANOVA|||||||= 0.0077
71875533|NCT03027557|143269167|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
71875534|NCT03027557|143269168|SUPERIORITY||||||=|0.011|||||||ANOVA|||||||= 0.011
71875535|NCT03027557|143269169|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
71875536|NCT03027557|143269170|SUPERIORITY||||||<|1e-05|||||||ANOVA|||||||< 0.00001
71875537|NCT03027557|143269171|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
71875538|NCT03027557|143269172|SUPERIORITY||||||=|0.0001|||||||ANOVA|||||||= 0.0001
71875539|NCT03027557|143269173|SUPERIORITY||||||=|0.0001|||||||Kruskal-Wallis|||||||= 0.0001
71875540|NCT03027557|143269175|SUPERIORITY||||||=|0.5|||||||Kruskal-Wallis|||||||= 0.5
71875541|NCT03027557|143269176|SUPERIORITY||||||=|0.85|||||||ANOVA|||||||= 0.85
71875542|NCT03027557|143269177|SUPERIORITY||||||=|0.22|||||||ANOVA|||||||= 0.22
71875543|NCT03027557|143269178|SUPERIORITY||||||=|0.18|||||||Kruskal-Wallis|||||||= 0.18
71875544|NCT03836807|143269189|SUPERIORITY|||||||0.02|||||||ANOVA|||||||0.020
71875545|NCT03836807|143269190|SUPERIORITY|||||||0.026|||||||ANOVA|||||||0.026
71875546|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-0.3||||0.914|TWO_SIDED|95.0|-5.5|5.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at Baseline (at 0')||5.0|-5.5|0.914
71875547|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|1.3||||0.685|TWO_SIDED|95.0|-4.9|7.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||7.4|-4.9|0.685
71875548|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-0.3||||0.93|TWO_SIDED|95.0|-7.4|6.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||6.8|-7.4|0.930
71875549|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-2.1||||0.615|TWO_SIDED|95.0|-10.3|6.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||6.1|-10.3|0.615
71875550|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-8.5||||0.051|TWO_SIDED|95.0|-17.0|0.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||0|-17.0|0.051
71875551|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-8.4||||0.043|TWO_SIDED|95.0|-16.6|-0.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||-0.3|-16.6|0.043
71875552|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-9.0||||0.023|TWO_SIDED|95.0|-16.7|-1.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||-1.3|-16.7|0.023
71875553|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-10.5||||0.009|TWO_SIDED|95.0|-18.2|-2.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||-2.7|-18.2|0.009
71875554|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-9.3||||0.018|TWO_SIDED|95.0|-17.0|-1.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||-1.7|-17.0|0.018
71875555|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-5.5||||0.182|TWO_SIDED|95.0|-13.6|2.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||2.6|-13.6|0.182
71875556|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-4.8||||0.236|TWO_SIDED|95.0|-12.9|3.2|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 4h||3.2|-12.9|0.236
71875557|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-3.6||||0.32|TWO_SIDED|95.0|-10.6|3.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5h||3.5|-10.6|0.320
71875558|NCT03836807|143269191|SUPERIORITY||adjusted least square mean|-2.2||||0.572|TWO_SIDED|95.0|-10.0|5.6|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||5.6|-10.0|0.572
71875559|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|2.7||||0.361|TWO_SIDED|95.0|-3.1|8.4|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||8.4|-3.1|0.361
71875560|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|4.2||||0.298|TWO_SIDED|95.0|-3.8|12.3|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 10'||12.3|-3.8|0.298
71875561|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|8.9||||0.112|TWO_SIDED|95.0|-2.1|19.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 15'||19.8|-2.1|0.112
71875562|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.8|36.8|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 30'||36.8|7.8|0.003
71875563|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|21.2||||0.008|TWO_SIDED|95.0|5.6|36.7|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 45'||36.7|5.6|0.008
71875564|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|18.7||||0.018|TWO_SIDED|95.0|3.3|34.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1h||34.0|3.3|0.018
71875565|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|22.3||||0.003|TWO_SIDED|95.0|7.7|37.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 1.5h||37.0|7.7|0.003
71875566|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|22.0||||0.003|TWO_SIDED|95.0|8.0|36.1|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 2h||36.1|8.0|0.003
71875567|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|16.7||||0.015|TWO_SIDED|95.0|3.4|30.0|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 3h||30.0|3.4|0.015
71875568|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|10.8||||0.103|TWO_SIDED|95.0|-2.2|23.9|||ANOVA|||at 4h||23.9|-2.2|0.103
71875569|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|5.9||||0.311|TWO_SIDED|95.0|-5.6|17.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 5'||17.5|-5.6|0.311
71875570|NCT03836807|143269192|SUPERIORITY||adjusted least square mean|2.8||||0.638|TWO_SIDED|95.0|-9.0|14.5|||ANOVA|The ANOVA model included fixed effect terms for clinical site, time point and treatment. Time point was specified as a repeated measurement.||at 6h||14.5|-9.0|0.638
71875571|NCT03836807|143269193|SUPERIORITY|||||||0.007|||||||ANOVA|||in the ITT population||||0.007
71875572|NCT03836807|143269193|SUPERIORITY|||||||0.009|||||||ANOVA|||in the PP population||||0.009
71875573|NCT03836807|143269194|SUPERIORITY|||||||0.004|||||||Log Rank|||||||0.004
71875574|NCT03836807|143269195|SUPERIORITY|||||||0.002|||||||Log Rank|||||||0.002
71875575|NCT03836807|143269196|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.480
71875576|NCT02430051|143269197|SUPERIORITY|||||||0.01|||||||Mixed-effects regression model|Adjusted for attained age and first or second clinic visit.||||||0.01
71875577|NCT02430051|143269198|SUPERIORITY|||||||0.25|||||||Mixed-effects regression model|Adjustment for attained age and first and second clinic visit.||||||0.25
71875578|NCT02430051|143269199|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71875579|NCT02430051|143269200|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71875580|NCT02430051|143269201|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71875581|NCT02430051|143269202|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71875582|NCT02430051|143269203|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71875583|NCT02430051|143269204|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71875584|NCT02430051|143269205|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71684006|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, body state image satisfaction were equivalent across time||||<0.001
71684007|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from baseline to post intervention. Null hypothesis: there would be no significant differences in state body image satisfaction from baseline to post intervention.||||<0.05
71684008|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure the difference in state body image satisfaction from post intervention to follow-up. Null hypothesis: there would be no significant differences in state body image satisfaction from post-intervention to follow-up.||||<0.001
71684009|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal body state image satisfaction||||>0.05
71684010|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal state body satisfaction scores||||>0.05
71684011|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in state body image satisfaction||||>0.05
71684012|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in state body image satisfaction across time.||||>0.05
71684013|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on state body image satisfaction||||>0.05
71875585|NCT02430051|143269206|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||||||0.76
71875586|NCT02430051|143269207|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.80
71684014|NCT03646305|142886290|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance alpha level.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between four conditions on state body image satisfaction||||>0.05
71684015|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, state body image satisfaction were equivalent across time.||||<0.001
71684016|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||A paired sample t-test was conducted to measure differences in anxious mood from baseline to post-intervention. Null hypothesis: there would be no significant difference in anxious mood from baseline to post-intervention.||||<0.001
71684017|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in anxious mood from post-intervention to follow-up. Null hypothesis: there would be no significant difference in anxious mood from post-intervention to follow-up||||>0.05
71875587|NCT02430051|143269208|SUPERIORITY||||||<|0.0001|||||||Multivariate linear regression|Adjusted for autism severity, IQ, dental fear and anxiety, sensory over-responsivity, general anxiety, expressive communication, gender, and age.||||||<0.0001
71875588|NCT02430051|143269209|SUPERIORITY|||||||0.61|||||||General linear mixed model|||||||0.61
71875589|NCT02019420|143269220|NON_INFERIORITY|Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI \> -10.|Difference in all-cause mortality|-1.8|||||TWO_SIDED|95.0|-8.2|4.7|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||4.7|-8.2|
71875590|NCT02019420|143269221|OTHER|Difference in mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.6|||||TWO_SIDED|95.0|-10.3|7.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||7.1|-10.3|
71875591|NCT02019420|143269222|OTHER|Difference in ITT clinical success (tedizolid - linezolid)|Difference in clinical success|-7.6|||||TWO_SIDED|95.0|-14.7|-0.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-0.5|-14.7|
71875592|NCT02019420|143269223|OTHER|Difference in CE clinical success (tedizolid - linezolid)|Difference in clinical success|-6.5|||||TWO_SIDED|95.0|-15.1|2.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||2.1|-15.1|
71916597|NCT01874353|143354858|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.22|3.97||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes treatment factor only|A hazard ratio \< 1 favours olaparib|||3.97|0.22|
71875593|NCT02019420|143269224|OTHER|Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.5|||||TWO_SIDED|95.0|-12.5|9.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||9.5|-12.5|
71875594|NCT02019420|143269225|OTHER|Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||18.9|-12.8|
71875595|NCT02019420|143269226|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
71916598|NCT01874353|143354859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.03||||0.9765|TWO_SIDED|95.0|-2.191|2.126|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.||||2.126|-2.191|0.9765
71916599|NCT01874353|143354860|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.48||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.48|0.28|<0.0001
71875596|NCT02019420|143269227|OTHER|Difference in ME-1 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||TWO_SIDED|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-4.5|-21.7|
71916600|NCT01874353|143354860|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.21|1.08||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours olaparib|||1.08|0.21|
71875597|NCT02019420|143269228|OTHER|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-12.5|||||TWO_SIDED|95.0|-21.5|-3.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-3.5|-21.5|
71875598|NCT02019420|143269229|OTHER|Difference in ME-2 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.7|||||TWO_SIDED|95.0|-26.2|-1.2|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.|||-1.2|-26.2|
71875599|NCT02510560|143269232|SUPERIORITY|||||||0.115|||||||Stratified Van Elteren Test|||||||0.115
71875600|NCT02510560|143269232|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
71875601|NCT02510560|143269233|SUPERIORITY|||||||0.714|||||||Stratified Van Elteren Test|||||||0.714
71875602|NCT02510560|143269233|SUPERIORITY|||||||0.243|||||||Stratified Van Elteren Test|||||||0.243
71875603|NCT02554903|143269234|SUPERIORITY||Geometric Mean Ratio|0.7393||||0.0158|TWO_SIDED|95.0|0.5798|0.9426|||ANCOVA|||||0.9426|0.5798|0.0158
71916601|NCT01874353|143354861|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.68||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.68|0.39|<0.0001
71916602|NCT01874353|143354861|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.37|1.85||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model included treatment factor only|A hazard ratio \< 1 favours olaparib|||1.85|0.37|
71916603|NCT01874353|143354862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.37|||<|0.0001|TWO_SIDED|95.0|0.28|0.49||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.49|0.28|<0.0001
71916604|NCT01874353|143354862|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.2|1.04||Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.|Regression, Cox|Model includes a treatment factor only|A hazard ratio \< 1 favours the Olaparib arm|||1.04|0.20|
71875604|NCT03951220|143269363|SUPERIORITY|||||||0.7343|||||||ANOVA|||||||0.7343
71875605|NCT03951220|143269364|OTHER|Correlation|Spearman (r)|0.39||||0.0445|TWO_SIDED|95.0|0.0|0.68|||Spearman's rank correlation coeffcieitn|||||0.68|0.00|0.0445
71875606|NCT03951220|143269365|SUPERIORITY|||||||0.0079||||||Dunn's multiple comparisons test|Kruskal-Wallis|||For baseline P1NP||||0.0079
71875607|NCT03951220|143269365|SUPERIORITY|||||||0.0482||||||Dunn's multiple comparison test|ANOVA|||For baseline sclerostin||||0.0482
71875608|NCT03951220|143269376|OTHER|||||||0.015|||||||Fisher-Freeman-Halton exact test|||||||0.015
71875609|NCT03951220|143269379|OTHER|||||||0.007|||||||Mann-Whitney test|||||||0.007
71916605|NCT01874353|143354863|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.3|||<|0.0001|TWO_SIDED|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio \< 1 favours olaparib|||0.40|0.22|<0.0001
71875610|NCT02038920|143269399|SUPERIORITY||Odds Ratio (OR)|1.8||||0.1448|TWO_SIDED|95.0|0.816|3.958|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||3.958|0.816|0.1448
71875611|NCT02038920|143269400|SUPERIORITY||Odds Ratio (OR)|3.57||||0.1779|TWO_SIDED|95.0|0.532|23.953|||Pearson's Chi-square Test||MLN0002 group/placebo group|||23.953|0.532|0.1779
71875612|NCT02038920|143269406|SUPERIORITY||Odds Ratio (OR)|1.83||||0.1963|TWO_SIDED|95.0|0.72|4.673|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.|||4.673|0.720|0.1963
71875613|NCT02038920|143269408|SUPERIORITY||Odds Ratio (OR)|15.4||||0.0094|TWO_SIDED|95.0|1.473|160.972|||Pearson's Chi-square Test|||||160.972|1.473|0.0094
71875614|NCT02038920|143269409|SUPERIORITY||Odds Ratio (OR)|1.5||||0.6534|TWO_SIDED|95.0|0.254|8.844|||Pearson's Chi-square Test||MLN0002 group/placebo group.|||8.844|0.254|0.6534
71875615|NCT02038920|143269410|SUPERIORITY|||||||0.2059|||||||Pearson's Chi-square Test|||||||0.2059
71875616|NCT02383589|143269419|SUPERIORITY||Difference in proportion|30.8|||<|0.0001|TWO_SIDED|95.0|14.7|45.15||The analysis was stratified by the stratification factors applied at randomization.|Cochran-Mantel-Haenszel|||||45.15|14.70|<0.0001
71875617|NCT02383589|143269420|SUPERIORITY|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||||||0.0005
71875618|NCT02383589|143269421|SUPERIORITY||Adjusted Rate Ratio|0.12|||<|0.0001|TWO_SIDED|95.0|0.05|0.29||The model was adjusted for the following covariates in addition to log (each participant's duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.|Negative Binominal Regression|||||0.29|0.05|<0.0001
71875619|NCT02383589|143269422|SUPERIORITY||Hazard Ratio (HR)|4.83||||0.0003|TWO_SIDED|95.0|1.97|11.81||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||11.81|1.97|0.0003
71875620|NCT02383589|143269423|SUPERIORITY||Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.06|0.39||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank|||||0.39|0.06|<0.0001
71875621|NCT02383589|143269424|SUPERIORITY||Difference in Estimated Means|-2.872||||0.0012|TWO_SIDED|95.0|-4.577|-1.167||P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment|Mixed Model Repeated Measures|||||-1.167|-4.577|0.0012
71684018|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of anxiety||||>0.05
71916606|NCT03774875|143354873|SUPERIORITY||Adjusted Difference in Response Rates|31.9|STANDARD_ERROR_OF_MEAN|6.78|<|0.0001|TWO_SIDED|95.0|18.6|45.2|||Cochran-Mantel-Haenszel|The CMH (Cochran-Mantel-Haenszel) test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (apremilast - placebo) in response rates calculated using the weighted average of the treatment differences across the strata with the CMH weights.|||45.2|18.6|<0.0001
71916607|NCT03774875|143354874|SUPERIORITY||Least Squares (LS) Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|0.95|<|0.0001|TWO_SIDED|95.0|-7.15|-3.43|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and baseline value as a covariate.|Difference in LS Means = Apremilast - Placebo|||-3.43|-7.15|<0.0001
71916608|NCT03774875|143354875|SUPERIORITY||LS Mean Difference|-38.4|STANDARD_ERROR_OF_MEAN|14.12||0.0085|TWO_SIDED|95.0|-66.58|-10.14|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate variable.|LS Mean Difference = Apremilast - Placebo|||-10.14|-66.58|0.0085
71916609|NCT03774875|143354876|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.38|<|0.0001|TWO_SIDED|95.0|-2.34|-0.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-0.86|-2.34|<0.0001
71916610|NCT03774875|143354877|SUPERIORITY||LS Mean Difference|-16.1|STANDARD_ERROR_OF_MEAN|4.31||0.0003|TWO_SIDED|95.0|-24.63|-7.6|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||-7.60|-24.63|0.0003
71916611|NCT03774875|143354878|SUPERIORITY||Adjusted Difference in Response Rates|13.5|STANDARD_ERROR_OF_MEAN|6.3||0.0328|TWO_SIDED|95.0|1.1|25.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification of the 5 difficult to treat manifestation types at randomization.|The adjusted difference in response rates (Apremilast - Placebo) using the weighted average of the treatment differences across the strata with the CMH weights.|||25.8|1.1|0.0328
71916612|NCT03774875|143354879|SUPERIORITY||Adjusted Difference in Response Rates|37.0|STANDARD_ERROR_OF_MEAN|6.58|<|0.0001|TWO_SIDED|95.0|24.1|49.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the stratification of the 5 difficult to treat manifestation types at randomization.|Adjusted difference (Apremilast - Placebo) in response rates using the weighted average of the treatment differences across the strata with the CMH weights.|||49.9|24.1|<0.0001
71875622|NCT03660826|143269468|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.93|TWO_SIDED|95.0|0.91|2.3||Comparing Arm II vs Arm I (reference group)|Log Rank||||Comparing Arm II vs Arm I (reference group)|2.30|0.91|0.93
71875623|NCT03660826|143269468|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.06|TWO_SIDED|95.0|0.43|1.14|||Log Rank|||Comparing Arm III vs Arm I||1.14|0.43|0.06
71916613|NCT03774875|143354880|SUPERIORITY||LS Mean Difference|14.9|STANDARD_ERROR_OF_MEAN|18.55||0.4216|TWO_SIDED|95.0|-21.62|51.48|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||51.48|-21.62|0.4216
71875624|NCT03660826|143269468|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.62|TWO_SIDED|95.0|0.67|1.7|||Log Rank|||Comparing Arm IV vs Arm VII||1.70|0.67|0.62
71875625|NCT03660826|143269468|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.36|TWO_SIDED|95.0|0.58|1.46|||Log Rank|||Comparing Arm V vs Arm VII||1.46|0.58|0.36
71875626|NCT03660826|143269468|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.49|1.25|||Log Rank|||Comparing Arm VI vs VII||1.25|0.49|0.14
71875627|NCT03872453|143269488|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|4.2||||0.1214|TWO_SIDED|98.3|-2.3|10.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||10.7|-2.3|0.1214
71875628|NCT03872453|143269488|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.0||||0.0113|TWO_SIDED|98.3|0.4|13.7||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.7|0.4|0.0113
71875629|NCT03872453|143269488|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.7||||0.0055|TWO_SIDED|98.3|1.1|14.3||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||14.3|1.1|0.0055
71875630|NCT03872453|143269489|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|5.4||||0.1162|TWO_SIDED|98.3|-2.8|13.6||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||13.6|-2.8|0.1162
71684019|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of anxiety||||>0.05
71684020|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of anxiety||||>0.05
71875631|NCT03872453|143269489|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.3||||0.0155|TWO_SIDED|98.3|0.1|16.5||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||16.5|0.1|0.0155
71875632|NCT03872453|143269489|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|8.9||||0.0094|TWO_SIDED|98.3|0.7|17.0||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||||17.0|0.7|0.0094
71916614|NCT03774875|143354881|SUPERIORITY||LS Mean Difference|-148.024|STANDARD_ERROR_OF_MEAN|103.9525||0.1559|TWO_SIDED|95.0|-352.8793|56.8304|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||56.8304|-352.8793|0.1559
71916615|NCT03774875|143354882|SUPERIORITY||LS Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|2.82||0.2667|TWO_SIDED|95.0|-2.43|8.73|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.73|-2.43|0.2667
71916616|NCT03774875|143354883|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|4.23||0.562|TWO_SIDED|95.0|-10.83|5.91|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||5.91|-10.83|0.5620
71916617|NCT03774875|143354884|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|4.81||0.8927|TWO_SIDED|95.0|-10.16|8.86|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||8.86|-10.16|0.8927
71916618|NCT03774875|143354885|SUPERIORITY||LS Mean Difference|-7.8|STANDARD_ERROR_OF_MEAN|4.09||0.0572|TWO_SIDED|95.0|-15.9|0.24|||ANCOVA|ANCOVA model with treatment arm and stratification factor as independent variables and the baseline value as a covariate.|LS Mean Difference = Apremilast - Placebo|||0.24|-15.90|0.0572
71916619|NCT05706623|143354911|OTHER|Analysis of variance model|Geometric least squares (LS) mean ratio|0.8354|||||TWO_SIDED|90.0|0.5216|1.338||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on natural log (ln) transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.338|0.5216|
71916620|NCT05706623|143354913|OTHER|Analysis of variance model|Geometric LS Mean Ratio|0.9356|||||TWO_SIDED|90.0|0.5889|1.4864||||||Moderate Hepatic Impairment Group (test) versus Normal Hepatic Function Group (reference). The analysis was performed on ln transformed parameters using an analysis of variance model with the hepatic function group as a fixed effect.||1.4864|0.5889|
71916621|NCT03233308|143354923|OTHER|||||||0.001|||||||t-test, 1 sided|||Mean Change from Baseline||||0.0010
71916622|NCT03233308|143354924|OTHER|||||||0.0003|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)||||0.0003
71916623|NCT03233308|143354925|OTHER|||||||0.0687|||||||t-test, 1 sided|||Mean change from baseline -EVP||||0.0687
71916624|NCT03233308|143354925|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline -IOP||||<0.0001
71916625|NCT03233308|143354926|OTHER|||||||0.0087|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline) -EVP||||0.0087
71916626|NCT03233308|143354926|OTHER||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)- IOP||||<0.0001
71916627|NCT02219516|143354941|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|153.0|||||TWO_SIDED|90.0|115.0|203.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||203|115|
71916628|NCT02219516|143354941|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|173.0|||||TWO_SIDED|90.0|131.0|230.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||230|131|
71916629|NCT02219516|143354941|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|228.0|||||TWO_SIDED|90.0|155.0|336.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||336|155|
71916630|NCT02219516|143354943|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|131.0|||||TWO_SIDED|90.0|98.6|174.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||174|98.6|
71875633|NCT03872453|143269490|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.1||||0.0439|TWO_SIDED|98.3|-1.3|15.4||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.4|-1.3|0.0439
71875634|NCT03872453|143269490|SUPERIORITY|The stratified percentage difference between zavegepant group and placebo was tested at a Bonferroni-corrected alpha level of 0.0167.|Stratified Percentage Difference|7.5||||0.0302|TWO_SIDED|98.3|-0.8|15.9||Threshold for significance at 0.0167 level.|Cochran-Mantel-Haenszel|||If the coprimary endpoint tests were both significant for a zavegepant dose group versus placebo, the secondary endpoints were tested for that zavegepant dose group versus placebo using a hierarchical gate-keeping procedure in the order the endpoints are reported, with each test in the hierarchy conducted at alpha = 0.0167. If a test in the hierarchy was not significant, any further tests on endpoints in the sequence were not considered significant for any zavegepant dose group versus placebo.||15.9|-0.8|0.0302
71875635|NCT00863109|143269521|SUPERIORITY_OR_OTHER|||||||0.027|||||||Student´s t-test for paired samples|||Within-group comparison of Worry domain between BL Visit and WK72 Visit||||0.027
71875636|NCT00863109|143269522|SUPERIORITY_OR_OTHER|||||||0.038|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in MCS||||0.038
71875637|NCT00863109|143269523|SUPERIORITY_OR_OTHER|||||||0.014|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Emotional Function domain||||0.014
71875638|NCT00863109|143269523|SUPERIORITY_OR_OTHER|||||||0.009|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Worry domain||||0.009
71875639|NCT00863109|143269523|SUPERIORITY_OR_OTHER|||||||0.022|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in CLDQ-HCV Global domain||||0.022
71916631|NCT02219516|143354943|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|222.0|||||TWO_SIDED|90.0|171.0|287.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||287|171|
71916632|NCT02219516|143354943|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|211.0|||||TWO_SIDED|90.0|139.0|319.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||319|139|
71916633|NCT02219516|143354944|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|124.0|||||TWO_SIDED|90.0|88.8|173.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||173|88.8|
71916634|NCT02219516|143354944|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|248.0|||||TWO_SIDED|90.0|168.0|366.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||366|168|
71916635|NCT02219516|143354944|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|230.0|||||TWO_SIDED|90.0|146.0|363.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||363|146|
71875640|NCT00440700|143269544|SUPERIORITY_OR_OTHER||Slope|15.5|||<|0.05||95.0|||||Mixed Models Analysis|||Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.||||<0.05
71875641|NCT00440700|143269546|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|0.61|<|0.05|ONE_SIDED|95.0|||||Kruskal-Wallis||Usual care was the reference comparison group.|Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.||||<0.05
71875642|NCT00440700|143269547|SUPERIORITY_OR_OTHER||Slope|5.0|||<|0.05||95.0|||||Mixed Models Analysis|||Cortisol levels were compared among all 3 groups.||||<0.05
71875643|NCT01423812|143269588|OTHER||||||<|0.05|||||||t-test, 2 sided|||p value||||<0.05
71916636|NCT02219516|143354946|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|76.0|||||TWO_SIDED|90.0|57.1|101.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||101|57.1|
71916637|NCT02219516|143354946|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|45.1|||||TWO_SIDED|90.0|34.9|58.3|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||58.3|34.9|
71916638|NCT02219516|143354946|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|47.8|||||TWO_SIDED|90.0|31.5|72.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||72.5|31.5|
71875644|NCT01423812|143269589|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71875645|NCT01179672|143269593|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.03|TWO_SIDED|95.0|-0.82|-0.04|||Mixed Models Analysis|||||-0.04|-0.82|0.030
71916639|NCT02219516|143354947|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|80.8|||||TWO_SIDED|90.0|57.9|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|57.9|
71875646|NCT01179672|143269594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.008|TWO_SIDED|95.0|-0.95|-0.14||P-value is for mean change from baseline to 12-week endpoint in night pain.|Mixed Models Analysis|||||-0.14|-0.95|0.008
71916640|NCT02219516|143354947|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|40.3|||||TWO_SIDED|90.0|27.3|59.5|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||59.5|27.3|
71916641|NCT02219516|143354947|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|43.5|||||TWO_SIDED|90.0|27.5|68.7|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||68.7|27.5|
71916642|NCT02219516|143354948|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.4|||||TWO_SIDED|90.0|60.6|150.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||150|60.6|
71916643|NCT02219516|143354948|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|58.3|||||TWO_SIDED|90.0|30.2|113.0|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||113|30.2|
71916644|NCT02219516|143354948|NON_INFERIORITY_OR_EQUIVALENCE|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|21.2|||||TWO_SIDED|90.0|13.6|32.8|||Fixed Effects Model|Treatment as a fixed effect was used to analyze the natural log-transformed PK parameters and GLSMRs are back-transformed to the original scale.||||32.8|13.6|
71875647|NCT01179672|143269594|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.017|TWO_SIDED|95.0|-1.0|-0.1||P-value is for mean change from baseline to 12 week endpoint in worst pain.|Mixed Models Analysis|||||-0.10|-1.00|0.017
71875648|NCT01179672|143269595|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.016|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||||-0.09|-0.90|0.016
71875649|NCT01179672|143269596|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.081|TWO_SIDED|95.0|-0.48|0.03|||Mixed Models Analysis|||||0.03|-0.48|0.081
71875650|NCT01179672|143269597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.034|TWO_SIDED|95.0|-0.4|-0.02|||Mixed Models Analysis|||||-0.02|-0.40|0.034
71875651|NCT01179672|143269598|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.022|TWO_SIDED|95.0|-2.07|-0.16|||ANCOVA|ANCOVA adjusted for treatment, pooled investigator and baseline.||||-0.16|-2.07|0.022
71875652|NCT01179672|143269599|SUPERIORITY_OR_OTHER|||||||0.014||||||P-value is for ≥30% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.014
71916645|NCT03797144|143355025|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.06|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.06
71916646|NCT03797144|143355025|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012|||||||t-test, 1 sided|||"To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_ODI ≤ 0, and the alternative hypothesis was Ha: μ\_ODI \> 0 where μ\_ODI is the mean improvement of ODI score at 3 months from baseline."||||0.012
71916647|NCT03797144|143355026|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||0.002
71875653|NCT01179672|143269599|SUPERIORITY_OR_OTHER|||||||0.006||||||P-value is for ≥50% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.006
71875654|NCT01179672|143269599|SUPERIORITY_OR_OTHER|||||||0.193||||||P-value is for ≥75% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.193
71875655|NCT01179672|143269600|SUPERIORITY_OR_OTHER|||||||0.003||||||P-value is for ≥30% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.003
71875656|NCT01179672|143269600|SUPERIORITY_OR_OTHER|||||||0.001||||||P-value is for ≥50% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.||||||0.001
71875657|NCT01179672|143269600|SUPERIORITY_OR_OTHER|||||||0.168||||||P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel test was stratified by pooled investigator.||||||0.168
71875658|NCT01179672|143269601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-0.96|-0.24|||Mixed Models Analysis|||||-0.24|-0.96|0.001
71875659|NCT01179672|143269602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.02|TWO_SIDED|95.0|-2.33|-0.2|||Mixed Models Analysis|||||-0.20|-2.33|0.020
71875660|NCT02748018|143269604|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.4||||||||-0.4||
71875661|NCT02748018|143269605|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.9|||||ONE_SIDED|97.5||-3.6||||||||-3.6||
71875662|NCT02748018|143269606|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
71875663|NCT02748018|143269607|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.8|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
71875664|NCT02748018|143269608|SUPERIORITY|Test of Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.3||||||||0.3||
71875665|NCT02748018|143269609|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-1.0|||||ONE_SIDED|97.5||-0.2||||||||-0.2||
71875666|NCT02748018|143269610|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-2.2|||||ONE_SIDED|97.5||-0.9||||||||-0.9||
71875667|NCT02748018|143269611|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
71875668|NCT02748018|143269612|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) During Night|Mean Difference (Final Values)|-5.4|||||ONE_SIDED|97.5||-3.7||||||||-3.7||
71875669|NCT02748018|143269613|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) During Night|Mean Difference (Final Values)|18.8|||||ONE_SIDED|97.5|14.5||||||||||14.5|
71875670|NCT02748018|143269614|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|12.0|||||ONE_SIDED|97.5|8.8||||||||||8.8|
71875671|NCT02748018|143269615|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-2.6||||||||-2.6||
71875672|NCT02748018|143269616|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.6|||||ONE_SIDED|97.5||-0.3||||||||-0.3||
71875673|NCT02748018|143269617|NON_INFERIORITY|Non-inferiority margin: 2%. Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-3.6|||||ONE_SIDED|97.5||-1.9||||||||-1.9||
71875674|NCT02748018|143269618|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.1|||||ONE_SIDED|97.5||0.3||||||||0.3||
71875675|NCT02748018|143269619|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-7.3|||||ONE_SIDED|97.5||-4.7||||||||-4.7||
71875676|NCT02748018|143269620|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|15.9|||||ONE_SIDED|97.5|11.1||||||||||11.1|
71875677|NCT02748018|143269621|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|13.6|||||ONE_SIDED|97.5|9.9||||||||||9.9|
71875678|NCT02748018|143269622|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-4.3|||||ONE_SIDED|97.5||-3.1||||||||-3.1||
71875679|NCT02748018|143269623|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|-0.2|||||ONE_SIDED|97.5||0.0||||||||0.0||
71875680|NCT02748018|143269624|NON_INFERIORITY|Non-inferiority margin: 2%. Treatment Effect on Time in Hypoglycemic Range (%) with Multiple Imputation|Mean Difference (Final Values)|-0.3|||||ONE_SIDED|97.5||0.7||||||||0.7||
71875681|NCT02748018|143269625|NON_INFERIORITY|Non-inferiority margin: 0.4%. Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
71875682|NCT02748018|143269626|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%) during Night|Mean Difference (Final Values)|-0.7|||||ONE_SIDED|97.5||0.2||||||||0.2||
71875683|NCT02748018|143269627|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%) during Night|Mean Difference (Final Values)|12.2|||||ONE_SIDED|97.5|8.3||||||||||8.3|
71875684|NCT02748018|143269628|SUPERIORITY|Test of Treatment Effect on Time in Target Range (%)|Mean Difference (Final Values)|6.3|||||ONE_SIDED|97.5|3.3||||||||||3.3|
71875685|NCT02748018|143269629|SUPERIORITY|Test of Treatment Effect on Time in Hypoglycemic Range (%)|Mean Difference (Final Values)|-0.8|||||ONE_SIDED|97.5||-0.1||||||||-0.1||
71875686|NCT02748018|143269630|SUPERIORITY|Treatment Effect on Change in A1C with Multiple Imputation|Mean Difference (Final Values)|0.0|||||ONE_SIDED|97.5||0.1||||||||0.1||
71875687|NCT00578786|143269655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0|STANDARD_DEVIATION|74.28|||TWO_SIDED|95.0|22.7|53.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||53.3|22.7|
71875688|NCT00578786|143269655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.5|STANDARD_DEVIATION|78.55|||TWO_SIDED|95.0|21.1|43.8|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||43.8|21.1|
71875689|NCT00578786|143269655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|40.9|STANDARD_DEVIATION|72.85|||TWO_SIDED|95.0|26.1|55.7|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||55.7|26.1|
71875690|NCT00578786|143269655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|36.0|STANDARD_DEVIATION|75.97|||TWO_SIDED|95.0|28.3|43.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||43.7|28.3|
71875691|NCT00578786|143269656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.9|STANDARD_DEVIATION|96.14|||TWO_SIDED|95.0|5.1|44.7|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||44.7|5.1|
71875692|NCT00578786|143269656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.9|STANDARD_DEVIATION|94.5|||TWO_SIDED|95.0|14.2|41.6|||||Applies to Ambrisentan 5.0 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||41.6|14.2|
71875693|NCT00578786|143269656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.2|STANDARD_DEVIATION|72.97|||TWO_SIDED|95.0|22.4|52.0|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||52.0|22.4|
71875694|NCT00578786|143269656|SUPERIORITY_OR_OTHER||Median Difference (Net)|29.5|STANDARD_DEVIATION|89.81|||TWO_SIDED|95.0|20.4|38.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.|||38.7|20.4|
71875695|NCT00578786|143269657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7|STANDARD_DEVIATION|97.48|||TWO_SIDED|95.0|-13.4|26.8|||||Applies to Ambrisentan 2.5 mg group only. LOCF method of imputation.|||26.8|-13.4|
71875696|NCT00578786|143269657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|23.2|STANDARD_DEVIATION|100.69|||TWO_SIDED|95.0|8.7|37.8|||||Applies to Ambrisentan 5 mg group only. LOCF method of imputation.|||37.8|8.7|
71875697|NCT00578786|143269657|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.0|STANDARD_DEVIATION|84.38|||TWO_SIDED|95.0|10.9|45.1|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation.|||45.1|10.9|
71875698|NCT00578786|143269657|SUPERIORITY_OR_OTHER||Median Difference (Net)|20.3|STANDARD_DEVIATION|96.05|||TWO_SIDED|95.0|10.6|30.1|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||30.1|10.6|
71875699|NCT00578786|143269658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7|STANDARD_DEVIATION|95.21|||TWO_SIDED|95.0|-18.9|20.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||20.3|-18.9|
71875700|NCT00578786|143269658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.8|STANDARD_DEVIATION|101.22|||TWO_SIDED|95.0|4.2|33.5|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||33.5|4.2|
71875701|NCT00578786|143269658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.8|STANDARD_DEVIATION|87.07|||TWO_SIDED|95.0|10.1|45.4|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||45.4|10.1|
71875702|NCT00578786|143269658|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.6|STANDARD_DEVIATION|96.54|||TWO_SIDED|95.0|6.8|26.4|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||26.4|6.8|
71875703|NCT00578786|143269660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08|STANDARD_DEVIATION|2.254|||TWO_SIDED|95.0|-0.55|0.38|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.38|-0.55|
71916648|NCT03797144|143355026|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Back Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
71875704|NCT00578786|143269660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59|STANDARD_DEVIATION|2.45|||TWO_SIDED|95.0|-0.94|-0.23|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.23|-0.94|
71875705|NCT00578786|143269660|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_DEVIATION|2.4|||TWO_SIDED|95.0|-1.0|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-1.00|
71875706|NCT00578786|143269660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_DEVIATION|2.393|||TWO_SIDED|95.0|-0.69|-0.2|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.20|-0.69|
71875707|NCT00578786|143269661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_DEVIATION|2.603|||TWO_SIDED|95.0|-0.31|0.76|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.76|-0.31|
71875708|NCT00578786|143269661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33|STANDARD_DEVIATION|2.477|||TWO_SIDED|95.0|-0.68|0.03|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.03|-0.68|
71875709|NCT00578786|143269661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65|STANDARD_DEVIATION|2.305|||TWO_SIDED|95.0|-1.12|-0.18|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.18|-1.12|
71875710|NCT00578786|143269661|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|STANDARD_DEVIATION|2.48|||TWO_SIDED|95.0|-0.52|-0.02|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.02|-0.52|
71875711|NCT00578786|143269662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_DEVIATION|2.593|||TWO_SIDED|95.0|-0.33|0.74|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.74|-0.33|
71684021|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of anxiety across time||||>0.05
71875712|NCT00578786|143269662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.514|||TWO_SIDED|95.0|-0.51|0.22|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.22|-0.51|
71916649|NCT03797144|143355026|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
71916650|NCT03797144|143355026|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."|||||<|0.001||||||Leg Pain|t-test, 1 sided|||"To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_VAS ≤ 0, and the alternative hypothesis was Ha: μ\_VAS \> 0 where μ\_VAS is the mean improvement of VAS score at 3 months from baseline."||||<0.001
71875713|NCT00578786|143269662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_DEVIATION|2.215|||TWO_SIDED|95.0|-0.93|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||-0.03|-0.93|
71875714|NCT00578786|143269662|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_DEVIATION|2.467|||TWO_SIDED|95.0|-0.39|0.11|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.|||0.11|-0.39|
71916651|NCT03797144|143355027|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.174||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.174
71916652|NCT03797144|143355027|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.002||||||Health State Score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.002
71875715|NCT05105789|143269675|SUPERIORITY|"One-sample binomial test. Null hypothesis: NPV of BinaxNOW at Home testing is at most 91%.~Alternative hypothesis: NPV of BinaxNOW at Home testing is greater than 91%."|Kappa Co-efficient|100.0||||0.0015|TWO_SIDED|95.0|95.0|100.0|||one-sample binomial test||binary outcome|Negative Predictive Value||100|95|0.0015
71875716|NCT05105789|143269675|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.3308|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.3308
71875717|NCT05105789|143269675|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR of 99%||||||0.0536|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0536
71875718|NCT05105789|143269676|EQUIVALENCE|Concordance between the PCR test results will be evaluated by calculating the Kappa statistic which will be reported along with corresponding two-sided 95% confidence interval. The nonparametric bootstrap technique will be used to construct the confidence interval. A kappa statistic of \>0.95 will be considered as sufficient to define lollipop swab test non-inferior to the gold-standard PCR testing of nasal swabs.|Kappa Co-efficient|0.91|||||TWO_SIDED|95.0|0.78|1.0||||||Kappa statistics for Nasal Swab PCR vs Lollipop Swab PCR||1.00|0.78|
71875719|NCT05105789|143269677|NON_INFERIORITY|a non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.201|||||||one-sample binomial test|||Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05||||0.2010
71875720|NCT05105789|143269677|NON_INFERIORITY|non-inferiority margin of δ=5% and a sensitivity/specificity of PCR testing of 99%||||||0.0705|||||||one-sample binomial test|||Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05||||0.0705
71684022|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of anxiety||||>0.05
71684023|NCT03646305|142886291|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between the four conditions on levels of anxiety||||>0.05
71684024|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of depressive mood were equivalent across time.||||<0.001
71684025|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from depressive mood from baseline to post-intervention||||<0.001
71684026|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in depressive mood from post-intervention to follow-up. Null hypothesis: there would be no significant differences in depressive mood from post-intervention to follow-up.||||>0.05
71684027|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of depressive mood||||>0.05
71684028|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of depressive mood||||>0.05
71684029|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of depressive mood||||>0.05
71684030|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of depressive mood across time||||>0.05
71684031|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of depressive mood||||>0.05
71875721|NCT00323297|143269684|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|11.722||0.5802|TWO_SIDED|90.0|-21.843|17.087||A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.|ANCOVA|The mean difference in method of estimation is the difference between Sildenafil - placebo.||"The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one-sided significance level of 0.05, assuming a standard deviation of 60 meters.~This primary statistical analysis was carried for Week 12 data."||17.087|-21.843|0.5802
71875722|NCT01006265|143269719|SUPERIORITY||Treatment effect (rate ratio)|0.226|||<|0.0001|TWO_SIDED|95.0|0.133|0.384|||Negative binomial regression model|||||0.384|0.133|<0.0001
71875723|NCT01006265|143269719|SUPERIORITY||Treatment effect (rate ratio)|0.17|||<|0.0001|TWO_SIDED|95.0|0.1|0.289|||Negative binomial regression model|||||0.289|0.100|<0.0001
71875724|NCT01006265|143269719|SUPERIORITY||Treatment effect (rate ratio)|0.566||||0.0318|TWO_SIDED|95.0|0.337|0.952|||Negative binomial regression model|||||0.952|0.337|0.0318
71916653|NCT03797144|143355027|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.003||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.003
71916654|NCT03797144|143355027|OTHER|"A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.~The normality of the data distribution was assessed with the Shapiro-Wilk test."||||||0.012||||||Index score|t-test, 1 sided|||"To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.~The null hypothesis was H0: μ\_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ\_EQ-5D 5L \> 0 where μ\_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline."||||0.012
71916655|NCT00376675|143355044|SUPERIORITY_OR_OTHER|||||||0.317|||||||Wilcoxon rank sum test|||||||0.317
71916656|NCT00995215|143355053|OTHER|Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.||||||0.05||||||A P value \<0.05 was taken as indicative of statistical significance.|ANOVA|||The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.||||0.05
71916657|NCT01332851|143355074|SUPERIORITY||Cox Proportional Hazard|2.5|||=|0.043|TWO_SIDED|95.0|1.03|6.1||We used a threshold of p \< .05 as the criterion for statistical significance.|Regression, Cox||The hazard ratio of 2.5 indicates that children with parents in the control group were 2.5 times more likely to be removed from their home and placed into foster care compared to the intervention group.|Child welfare system removals were analyzed with a survival models that used condition assignment to predict hazard of being removed from the birth parent home.||6.10|1.03|=.043
71916658|NCT01332851|143355075|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|0.42|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Parents in the PFR condition were 0.94 higher on sensitivity scores (on the unstandardized sensitivity measure) across the three post-intervention time points than parents in the R\&R condition. The standard error (SE) of this difference was .42.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline sensitivity score, months between baseline and end of intervention, and age of child at baseline.||||<.05
71916659|NCT01332851|143355076|SUPERIORITY||Mean Difference (Net)|0.05|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean compared to the R\&R group. (the absolute value of the standardized effect is d=.15).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline security score, months between baseline and end of intervention, and age of child at baseline||||>.05
71684032|NCT03646305|142886292|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no difference between 4 conditions on levels of depressive mood||||>0.05
71684033|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of happiness were equivalent across time||||>0.05
71684034|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of happiness||||>0.05
71684035|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would have equal levels of happiness||||>0.05
71684036|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of happiness||||>0.05
71684037|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of happiness across time.||||>0.05
71758558|NCT02205736|143019222|SUPERIORITY||||||<|0.0001||||||This outcome measure for Q25 was tested at the 2-sided, Bonferroni-corrected alpha=0.002 significance level to preserve an overall type I error rate of 5% in the analyses of 25 questions.|McNemar|||Patients gave True/False responses to Question 25 at Baseline and 3-Month Contact; the True/False responses were mapped to being correct or incorrect. The null hypothesis was that the intervention had no effect on breast health, or that the probability of answering incorrectly on the Baseline questionnaire and correctly on the 3-Month Contact questionnaire was equal to the probability of answering correctly on the Baseline questionnaire and incorrectly on the 3-Month Contact questionnaire.||||<.0001
71916660|NCT01332851|143355077|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across the two post-intervention time points was -.20 (SE=.50) lower in the PFR group than R\&R group. The standardized effect size was d=.04.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline.||||>.05
71684038|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
71684039|NCT03646305|142886293|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
71684040|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, levels of confidence were equivalent across time.||||>0.05
71684041|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of confidence||||>0.05
71684042|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of confidence||||>0.05
71684043|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA was used to analyze Intervention x Activity interaction. Null: On average, all four conditions were equivalent in levels of confidence||||>0.05
71875725|NCT03531788|143269722|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor provide data per participant during testing of upper extremity activities/tasks and were collected while wearing the device (Kinova and WREX) and without the device (Kinova and WREX). For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|Due to the small sample size, we utilized change in activity count data when comparing two upper limb testing sessions: one without the use of an arm support device (Kinova or WREX) and one while using the arm support device. For each upper extremity task, we summed all activity count data for all tasks completed. We then computed means and standard deviations. Data presented are within group data change and not between group data comparisons.|||
71875726|NCT03531788|143269723|OTHER|||||||||||||||||Activity counts from the ActiGraph GT9x activity monitor were collected during baseline (without a device) and throughout the 4 week device trial (with the device). For each time period, activity count data were averaged across the day. We then compared the baseline time period to the device trial period to understand the difference in movement and upper extremity positioning during the device trial. Data presented are within group change scores and not between group data comparisons.|Counts from each axis (x, y, z) were measured across baseline and during the 4-week trial to explore arm movement and positioning during the use of an upper extremity arm device. Counts (within each participant) were summed. A change score from trial minus baseline was calculated for each axis. We provide an average change score and standard deviation across participants with Kinova and participants with WREX.|||
71875727|NCT03531788|143269724|OTHER|||||||||||||||||Three goals were identified for each participant and scored without using an arm support device to serve as a baseline measure of abilities. These scores were compared to the scores achieved on the same goals using the arm support device.|We compared the change in GAS scores when using an arm support device on three goal areas identified as important for each participant. For each goal, we measured abilities at baseline and with the device (Kinova and WREX). We calculated the change in score for each goal and averaged these change scores across all participants. While our groups are too small to complete statistical tests to estimate the significance of the differences participants noted in activity and independence while using both arm supports, our results quantify the amount of increased success participants noted with the use of the arm support device.|||
71875728|NCT04427501|143269749|SUPERIORITY||Odds Ratio (OR)|0.3|||||TWO_SIDED|95.0|0.15|0.58||||||||0.58|0.15|
71875729|NCT04427501|143269749|SUPERIORITY||Odds Ratio (OR)|0.12|||||TWO_SIDED|95.0|0.04|0.31||||||||0.31|0.04|
71875730|NCT04427501|143269750|SUPERIORITY||Odds Ratio (OR)|0.23|||||TWO_SIDED|95.0|0.13|0.4||||||||0.40|0.13|
71875731|NCT04427501|143269751|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.221||0.6921|TWO_SIDED|95.0|-0.35|0.52|||Mixed Models Analysis|||||0.52|-0.35|0.6921
71875732|NCT04427501|143269751|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.219||0.211|TWO_SIDED|95.0|-0.71|0.16|||Mixed Models Analysis|||||0.16|-0.71|0.2110
71875733|NCT04427501|143269751|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|0.225||0.163|TWO_SIDED|95.0|-0.13|0.76|||Mixed Models Analysis|||||0.76|-0.13|0.1630
71875734|NCT04427501|143269751|SUPERIORITY||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.22||0.0099|TWO_SIDED|95.0|-1.0|-0.14|||Mixed Models Analysis|||||-0.14|-1.00|0.0099
71916661|NCT01332851|143355078|SUPERIORITY||Mean Difference (Net)|0.41|STANDARD_ERROR_OF_MEAN|0.53|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The adjusted mean across post-intervention time points was .41 (SE=.53) higher in the PFR group than the R\&R group. The standardized effect size was d=-.07|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline competence stress score, months between baseline and end of intervention, and age of child at baseline||||>.05
71916662|NCT01332851|143355079|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.25|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had a higher mean level of social and emotional development compared to the R\&R group (the absolute value of the standardized effect is d=.10).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline social-emotional competence score, months between baseline and end of intervention, and age of child at baseline.||||>.05
71875735|NCT04427501|143269756|SUPERIORITY||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|1.13|1.86||||||||1.86|1.13|
71875736|NCT04427501|143269756|SUPERIORITY||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|1.24|1.95||||||||1.95|1.24|
71875737|NCT04427501|143269756|SUPERIORITY||Odds Ratio (OR)|1.64|||||TWO_SIDED|95.0|1.06|2.53||||||||2.53|1.06|
71875738|NCT04427501|143269757|SUPERIORITY||Odds Ratio (OR)|1.5|||||TWO_SIDED|95.0|1.17|1.93||||||||1.93|1.17|
71875739|NCT04427501|143269757|SUPERIORITY||Odds Ratio (OR)|1.67|||||TWO_SIDED|95.0|1.33|2.09||||||||2.09|1.33|
71875740|NCT04427501|143269757|SUPERIORITY||Odds Ratio (OR)|1.88|||||TWO_SIDED|95.0|1.22|2.9||||||||2.9|1.22|
71875741|NCT04427501|143269758|SUPERIORITY||Odds Ratio (OR)|0.34|||||TWO_SIDED|95.0|0.18|0.64||||||||0.64|0.18|
71875742|NCT04427501|143269758|SUPERIORITY||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.07|0.38||||||||0.38|0.07|
71875743|NCT04427501|143269758|SUPERIORITY||Odds Ratio (OR)|0.25|||||TWO_SIDED|95.0|0.06|1.05||||||||1.05|0.06|
71875744|NCT04427501|143269759|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0|TWO_SIDED|95.0|-1.46|-0.94|||Mixed Models Analysis|||||-0.94|-1.46|<0.0000000
71875745|NCT04427501|143269759|SUPERIORITY||Mean Difference (Net)|-1.09|||<|0|TWO_SIDED|95.0|-1.34|-0.85|||Mixed Models Analysis|||||-0.85|-1.34|<0.0000000
71875746|NCT04427501|143269759|SUPERIORITY||Mean Difference (Net)|-0.99||||3.777e-05|TWO_SIDED|95.0|-1.45|-0.52|||Mixed Models Analysis|||||-0.52|-1.45|0.00003777
71875747|NCT04427501|143269760|SUPERIORITY||Hazard Ratio (HR)|1.213||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
71875748|NCT04427501|143269760|SUPERIORITY||Hazard Ratio (HR)|1.111||||0.13|TWO_SIDED||||||Stratified Log-rank|||||||0.130
71875749|NCT04427501|143269760|SUPERIORITY||Hazard Ratio (HR)|1.38||||0.012|TWO_SIDED||||||Stratified Log-rank|||||||0.012
71875750|NCT04427501|143269761|SUPERIORITY||Hazard Ratio (HR)|1.355||||0.007|TWO_SIDED||||||Stratified Log-rank|||||||0.007
71875751|NCT04427501|143269761|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.033|TWO_SIDED||||||Stratified Log-rank|||||||0.033
71875752|NCT04427501|143269761|SUPERIORITY||Hazard Ratio (HR)|1.521||||0.017|TWO_SIDED||||||Stratified Log-rank|||||||0.017
71875753|NCT04427501|143269762|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.243||0.499|TWO_SIDED|95.0|-0.31|0.64|||Mixed Models Analysis|||||0.64|-0.31|0.499
71875754|NCT04427501|143269762|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|0.241||0.492|TWO_SIDED|95.0|-0.64|0.31|||Mixed Models Analysis|||||0.31|-0.64|0.492
71875755|NCT04427501|143269762|SUPERIORITY||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.246||0.125|TWO_SIDED|95.0|-0.11|0.86|||Mixed Models Analysis|||||0.86|-0.11|0.125
71875756|NCT04427501|143269762|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.236||0.069|TWO_SIDED|95.0|-0.89|0.03|||Mixed Models Analysis|||||0.03|-0.89|0.069
71875757|NCT04427501|143269763|SUPERIORITY||Odds Ratio (OR)|1.74||||0.034|TWO_SIDED|95.0|1.04|2.9|||Regression, Logistic|||||2.90|1.04|0.034
71875758|NCT04427501|143269763|SUPERIORITY||Odds Ratio (OR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91|||Regression, Logistic|||||1.91|0.69|0.594
71875759|NCT04427501|143269763|SUPERIORITY||Odds Ratio (OR)|1.32||||0.291|TWO_SIDED|95.0|0.79|2.2|||Regression, Logistic|||||2.20|0.79|0.291
71684044|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions are equivalent in levels of confidence across time.||||>0.05
71684045|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of happiness||||>0.05
71684046|NCT03646305|142886294|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of happiness||||>0.05
71684047|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to measure main effect of time. Null: Across the sample, level of self-esteem were equivalent across time.||||<0.05
71684048|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||<|0.001|||||||t-test, 2 sided|||Paired sample t-tests was conducted to measure differences in self-esteem from post-intervention to follow-up. Null hypothesis: there would be no significant differences in self-esteem from post-intervention to follow-up.||||<0.001
71684049|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Intervention. Null: On average, the experimental conditions and control conditions would have equal levels of self-esteem||||>0.05
71684050|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze main effect of Activity. Null: On average, singing and verbal repetition would result in equal levels of self-esteem||||>0.05
71684051|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||Twenty-eight participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post-intervention, follow-up) mixed ANOVA used to analyze Intervention x Activity interaction. Null: On average, all four conditions have equivalent levels of self-esteem||||>0.05
71875760|NCT04427501|143269763|SUPERIORITY||Odds Ratio (OR)|1.45||||0.143|TWO_SIDED|95.0|0.88|2.4|||Regression, Logistic|||||2.40|0.88|0.143
71758559|NCT01285557|143019223|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9312|TWO_SIDED|95.0|0.76|1.28|||Unstratified Log-rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the unstratified log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.28|0.76|0.9312
71875761|NCT04427501|143269764|SUPERIORITY||Odds Ratio (OR)|1.89||||0.014|TWO_SIDED|95.0|1.14|3.15|||Regression, Logistic|||||3.15|1.14|0.014
71875762|NCT04427501|143269764|SUPERIORITY||Odds Ratio (OR)|1.06||||0.828|TWO_SIDED|95.0|0.64|1.74|||Regression, Logistic|||||1.74|0.64|0.828
71875763|NCT04427501|143269764|SUPERIORITY||Odds Ratio (OR)|1.82||||0.022|TWO_SIDED|95.0|1.09|3.02|||Regression, Logistic|||||3.02|1.09|0.022
71875764|NCT04427501|143269764|SUPERIORITY||Odds Ratio (OR)|1.48||||0.119|TWO_SIDED|95.0|0.9|2.43|||Regression, Logistic|||||2.43|0.90|0.119
71875765|NCT04427501|143269767|SUPERIORITY||Odds Ratio (OR)|0.23||||0.098|TWO_SIDED|95.0|0.04|1.31|||Regression, Logistic|||||1.31|0.04|0.098
71875766|NCT04427501|143269767|SUPERIORITY||Odds Ratio (OR)|0.37||||0.165|TWO_SIDED|95.0|0.09|1.51|||Regression, Logistic|||||1.51|0.09|0.165
71875767|NCT04427501|143269767|SUPERIORITY||Odds Ratio (OR)|0.39||||0.191|TWO_SIDED|95.0|0.1|1.6|||Regression, Logistic|||||1.60|0.10|0.191
71875768|NCT04427501|143269767|SUPERIORITY||Odds Ratio (OR)|0.21||||0.075|TWO_SIDED|95.0|0.04|1.18|||Regression, Logistic|||||1.18|0.04|0.075
71875769|NCT04427501|143269768|SUPERIORITY|||||||0.616|||||||Stratified Log-rank|||||||0.616
71875770|NCT04427501|143269768|SUPERIORITY|||||||0.281|||||||Stratified Log-rank|||||||0.281
71875771|NCT04427501|143269768|SUPERIORITY|||||||0.815|||||||Stratified Log-rank|||||||0.815
71875772|NCT04427501|143269768|SUPERIORITY|||||||0.334|||||||Stratified Log-rank|||||||0.334
71875773|NCT03739437|143269782|SUPERIORITY|||||||0.384|||||||Chi-squared|||||||0.384
71875774|NCT02499770|143269804|OTHER||||||=|0.0097||||||The p-value was calculated using the stratified log-rank test to account for the baseline ECOG status (0-1 vs 2) as the stratification factor. Significance level was set as two-sided 0.2.|Stratified log-rank test|p-value calculated using stratified log-rank test with baseline ECOG status (0-1 vs 2) as stratification factor. Significance level was two-sided 0.2.||||||= 0.0097
71875775|NCT02564926|143269855|OTHER||LS mean difference (kg)|-2.6|||<|0.001|TWO_SIDED|95.0|-3.346|-1.819|||ANCOVA|||||-1.819|-3.346|<0.001
71875776|NCT02564926|143269856|OTHER||LS mean difference (%)|-0.46||||0.014|TWO_SIDED|95.0|-0.821|-0.094|||Mixed Models Analysis|||||-0.094|-0.821|0.014
71875777|NCT02564926|143269857|OTHER||Odds Ratio (OR)|1.45||||0.343|TWO_SIDED|95.0|0.673|3.113|||Regression, Logistic|||||3.113|0.673|0.343
71875778|NCT02564926|143269858|OTHER||LS mean difference (mg/dL)|-18.25||||0.006|TWO_SIDED|95.0|-31.14|-5.351|||Mixed Models Analysis|||||-5.351|-31.140|0.006
71875779|NCT02564926|143269859|OTHER||LS mean difference (kg)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.667|-2.631|||Mixed Models Analysis|||||-2.631|-4.667|<0.001
71875780|NCT02564926|143269860|OTHER||LS mean difference (cm)|-2.21||||0.006|TWO_SIDED|95.0|-3.785|-0.635|||Mixed Models Analysis|||||-0.635|-3.785|0.006
71875781|NCT02564926|143269861|OTHER||LS mean difference (kg/m2)|-1.37|||<|0.001|TWO_SIDED|95.0|-1.742|-0.99|||Mixed Models Analysis|||||-0.990|-1.742|<0.001
71875782|NCT02564926|143269862|OTHER||LS mean difference (mmHg)|-6.81||||0.002|TWO_SIDED|95.0|-10.969|-2.641|||Mixed Models Analysis|||||-2.641|-10.969|0.002
71875783|NCT02564926|143269863|OTHER||LS mean difference (mmHg)|-2.61||||0.11|TWO_SIDED|95.0|-5.829|0.6|||Mixed Models Analysis|||||0.600|-5.829|0.110
71875784|NCT02564926|143269864|OTHER||LS mean difference (cm2)|-17.55||||0.002|TWO_SIDED|95.0|-28.603|-6.489|||ANCOVA|||||-6.489|-28.603|0.002
71875785|NCT02564926|143269865|OTHER||LS mean difference (cm2)|-18.39|||<|0.001|TWO_SIDED|95.0|-27.561|-9.218|||ANCOVA|||||-9.218|-27.561|<0.001
71875786|NCT02564926|143269866|OTHER||LS mean difference|-0.03||||0.503|TWO_SIDED|95.0|-0.127|0.063|||ANCOVA|||||0.063|-0.127|0.503
71875787|NCT02564926|143269867|OTHER||LS mean difference|-1.3|||<|0.001|TWO_SIDED|95.0|-1.992|-0.54|||ANCOVA|||||-0.540|-1.992|<0.001
71875788|NCT02564926|143269868|OTHER||LS mean difference (ng/mL)|657.71||||0.044|TWO_SIDED|95.0|18.325|1297.101|||ANCOVA|||||1297.101|18.325|0.044
71875789|NCT02564926|143269869|OTHER||LS mean difference (mg/L)|-0.12||||0.756|TWO_SIDED|95.0|-0.858|0.625|||ANCOVA|||||0.625|-0.858|0.756
71875790|NCT02564926|143269870|OTHER||LS mean difference (%)|-1.94|||<|0.001|TWO_SIDED|95.0|-2.807|-1.082|||ANCOVA|||||-1.082|-2.807|<0.001
71875791|NCT01554488|143269892|OTHER||Mean Difference (Net)|-1.03|||||TWO_SIDED|95.0|-5.03|2.92||||||All of the comparisons were based on mixed effects linear regression models with visit and group\*visit as fixed effects and subject as a random effect. Confidence intervals for the treatment difference (group\*visit interaction) were constructed using the Wald method.||2.92|-5.03|
71875792|NCT00866697|143269910|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.766||||0.0021|TWO_SIDED|95.0|0.643|0.911||The P-value from the stratified log-rank test was adjusted for the two stratification factors.|Log Rank||The Hazard Ratio was estimated using a Pike estimator.|||0.911|0.643|0.0021
71875793|NCT00866697|143269911|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.6431|TWO_SIDED|95.0|0.805|1.145|||Log Rank|Stratified Log-Rank P-Value.|"The HR was estimated using a Pike estimator.~CIs were estimated using the Brookmeyer-Crowley method."|||1.145|0.805|0.6431
71875794|NCT03219320|143269985|OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71684052|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect a moderate effect size (.25) at a significance level of alpha .05 in a mixed ANOVA according to a power analysis using GPower 3.1. A 2 (Intervention: experimental, control) × 3 (Time: baseline, post-intervention, follow-up) mixed ANOVA was used to measure Time x Intervention interactions. Null: experimental and control conditions have equivalent levels of self-esteem across time.||||>0.05
71684053|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Activity interaction. Null: Across time, there would be no difference between singing and verbal repetition on levels of self-esteem||||>0.05
71684054|NCT03646305|142886295|NON_INFERIORITY|This was a single-center, parallel-group study with balanced randomization of participants into one of four conditions. Condition (experimental: body-related thoughts vs control: neutral thoughts) was fully crossed with technique (singing vs verbal repetition) . This was a non-inferiority study to primarily examine whether singing is as effective as verbal repetition as a cognitive defusion strategy for body image distress.|||||>|0.05|||||||ANOVA|||28 participants per condition (N=112) would provide sufficient power (0.8) to detect moderate effect size (.25) at significance level of alpha.05 in mixed ANOVA according to power analysis using GPower 3.1. A 2(Intervention: experimental, control) × 2(Activity: singing, verbal repetition) × 3(Time: baseline, post, follow-up) mixed ANOVA was used to analyze Time x Intervention x Activity interaction. Null: Across time, there would be no differences between four conditions on levels of self-esteem||||>0.05
71684055|NCT03646305|142886296|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between intervention and each outcome measure. Null: homework adherence does not mediate any relationships between intervention condition and outcome measures.||||>0.05
71684056|NCT03646305|142886296|OTHER|Mediation Analysis that examined whether greater homework adherence strengthened the relationship between condition and outcome|||||>|0.05|||||||Mediation Analyses|||All mediation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 4, which includes one outcome variable, one predictor, one mediator, and room for covariates. We examined the meditational effect of homework adherence on the relationship between activity and each outcome measure. Null: homework adherence does not mediate any relationships between activity condition and outcome measures.||||>0.05
71684057|NCT03646305|142886297|OTHER|Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures.|||||<|0.001||||||No other outcome measure was moderated by thought-shape fusion scores.|Moderation Analyses|||All moderation analyses were conducted using the PROCESS SPSS macro version 3.2 (Hayes, 2018). We tested model 1, which includes one outcome variable, one predictor, and one moderator. Thought-shape fusion was examined as a potential moderator of the relationship between intervention condition and outcome measures. Null: thought-shape fusion does not significantly moderate the relationship between intervention condition and state self-esteem||||<0.001
71875795|NCT03739762|143269986|SUPERIORITY||Mean Difference (Final Values)|-31.85||||0.003|TWO_SIDED|95.0|-52.91|-10.79|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||The sample size of 284 ensured 90% power to detect a 41-minute difference in sitting time between I-STAND and the attention control from baseline to 6 months, assuming a standard deviation (SD) of 97 minutes/day for change in sitting time (based on our pilot data), and 15% loss to follow-up. Sample and power calculations were performed using R software version 3.5 \[39\] via simulation, assuming specified SDs and differences between means.||-10.79|-52.91|0.003
71875796|NCT03739762|143269987|SUPERIORITY||Mean Difference (Final Values)|-3.48||||0.033|TWO_SIDED|95.0|-6.68|-0.28|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||-0.28|-6.68|.033
71875797|NCT03739762|143269988|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.784|TWO_SIDED|95.0|-1.63|2.16|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.16|-1.63|.784
71916663|NCT01332851|143355080|SUPERIORITY||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.66|>|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower mean level of problem behavior compared to the R\&R group (the absolute value of standardized effect is d= .12).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline||||>.05
71916664|NCT01332851|143355081|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.07 (SE=.08) lower for PFR compared to R\&R group.|Tested mean differences by condition at 3-month follow-up controlling for baseline score, months between baseline and the end of the intervention, and age of child and using an ANVOVA/regression model. Null hypothesis was that post-intervention means were equal.||||>.05
71875798|NCT03739762|143269989|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.927|TWO_SIDED|95.0|-2.61|2.38|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||2.38|-2.61|.927
71684058|NCT03168919|142886301|OTHER|Comparison||||||||||||||||The baseline and the end of therapy MRI parameters are compared.|Due to very small accrual, the statistical analysis couln't be performed.|||
71875799|NCT03739762|143269990|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.916|TWO_SIDED|95.0|-0.42|0.47|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.47|-0.42|.916
71875800|NCT03739762|143269991|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.325|TWO_SIDED|95.0|-1.09|0.36|||Regression, Linear|The model fit was a linear regression model with GEE on the outcome change from baseline.||||0.36|-1.09|.325
71875801|NCT01681810|143269992|OTHER|Paired t-test comparing insulin stimulated glucose disposal at end of 12 weeks on nitrite drug to baseline (pre-drug) insulin stimulated glucose disposal.||||||0.2068|||||||t-test, 2 sided|||||||0.2068
71875802|NCT01681810|143269993|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.||||||0.0074||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0074
71875803|NCT01681810|143269994|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
71875804|NCT01681810|143269995|OTHER|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||<0.0001
71875805|NCT01681810|143269996|OTHER|One-way repeated measures ANOVA comparing methemoglobin percent over time on nitrite drug to baseline (pre-drug) methemoglobin percent.||||||0.0127||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||||||0.0127
71875806|NCT02294682|143270019|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|97.0|||||ONE_SIDED|95.0|85.1||||||GSK2140944 1500 mg||||85.1|
71875807|NCT02294682|143270019|SUPERIORITY_OR_OTHER||Microbio Response Urogenital Gonorrhea|95.0|||||ONE_SIDED|95.0|84.7||||||GSK2140944 3000 mg||||84.7|
71875808|NCT03383289|143270077|SUPERIORITY||Beta estimate of the percent who fell|0.118|STANDARD_ERROR_OF_MEAN|0.145||0.417|TWO_SIDED||||||Mixed Models Analysis|MIANALYZE was used to model missing data. Models were adjusted for the design effects of clustering.||||||0.4170
71875809|NCT03383289|143270079|OTHER|paired t test|Mean Difference (Final Values)|-1.353|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.708|-0.998|||paired t test|||Analysis of adjusted mean differences using a paired t test procedure||-0.998|-1.708|<0.001
71875810|NCT03383289|143270080|SUPERIORITY||Beta|0.6364|STANDARD_ERROR_OF_MEAN|0.233||0.0064|TWO_SIDED|95.0|0.1797|1.0931|||Poisson regression|||||1.0931|0.1797|0.0064
71875811|NCT03383289|143270080|SUPERIORITY||Estimated log mean|-4.0168||||0.001|TWO_SIDED|95.0|-5.5827|-2.4509|||Poisson regression|||||-2.4509|-5.5827|0.001
71758560|NCT01285557|143019224|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.3039|TWO_SIDED|95.0|0.65|1.14|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.14|0.65|0.3039
71875812|NCT03383289|143270081|OTHER|adjusted mean differences from paired t tests|Mean Difference (Final Values)|-0.456|STANDARD_ERROR_OF_MEAN|0.162||0.005|TWO_SIDED|95.0|-0.774|-0.138|||paired t test|||||-0.138|-0.774|0.005
71875813|NCT01002456|143270082|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0|1.1|3.2|||||Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.|||3.2|1.1|
71875814|NCT00129623|143270085|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.1226|||<|0.0001|TWO_SIDED|95.0|2.9613|5.2838||The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, \>3 years) as independent factors.|ANOVA|||"H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).~H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD)."||5.2838|2.9613|<0.0001
71875815|NCT00129623|143270091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.51|||||TWO_SIDED|95.0|5.12|30.56||||||Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||30.56|5.12|
71875816|NCT00129623|143270091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.59|||||TWO_SIDED|95.0|3.8|19.42||||||Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||19.42|3.80|
71875817|NCT00129623|143270091|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|13.8|||||TWO_SIDED|95.0|5.17|36.79||||||Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of \>1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.||36.79|5.17|
71875818|NCT05178134|143270099|NON_INFERIORITY|Non-inferiority margin was set to -15% (on an absolute scale)|Difference in response rates|-0.02|||||TWO_SIDED|95.0|-0.108|0.069||||||||0.069|-0.108|
71875819|NCT01214187|143270118|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|0.81||0.2072|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference = (Change from baseline to Week 12 for Carbon monoxide group) minus (Change from baseline to Week 12 for Placebo group)|||||0.2072
71875820|NCT01214187|143270119|SUPERIORITY||Mean Difference (Net)|-0.85|STANDARD_ERROR_OF_MEAN|1.57||0.5882|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|Difference = (Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.5882
71684059|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-10.5|STANDARD_ERROR_OF_MEAN|8.5||0.2179|TWO_SIDED|95.0|-27.4|6.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||6.3|-27.4|0.2179
71684060|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-14.6|STANDARD_ERROR_OF_MEAN|8.5||0.0883|TWO_SIDED|95.0|-31.5|2.2|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||2.2|-31.5|0.0883
71684061|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-12.6|STANDARD_ERROR_OF_MEAN|8.5||0.1414|TWO_SIDED|95.0|-29.4|4.3|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||4.3|-29.4|0.1414
71875821|NCT01214187|143270120|SUPERIORITY||Mean Difference (Net)|0.64|STANDARD_ERROR_OF_MEAN|1.93||0.7401|TWO_SIDED||||||ANOVA|Repeated Measure ANOVA|difference=(change from baseline to week 12 for CO group) minus (change from baseline to week 12 for placebo group)|||||0.7401
71875822|NCT01214187|143270121|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.46|STANDARD_ERROR_OF_MEAN|18.14||0.0099|TWO_SIDED||||||ANOVA|Repeated measure ANOVA|Difference=(Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)|||||0.0099
71875823|NCT01214187|143270122|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|2.42||0.8124|TWO_SIDED||||||ANOVA|Repeated measure ANOVA||||||0.8124
71875824|NCT00998426|143270127|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||This is the p value for the meter by time interaction|Random intercept model|||A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.||||0.59
71875825|NCT01178333|143270128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.98||||0.09|TWO_SIDED|95.0|0.9|4.36|||Regression, Cox|||||4.36|0.90|0.09
71875826|NCT01178333|143270128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.45|TWO_SIDED|95.0|0.65|2.66|||Regression, Cox|||||2.66|0.65|0.45
71875827|NCT01178333|143270130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.76||||0.15|TWO_SIDED|95.0|0.55|40.87|||Regression, Cox|||||40.87|0.55|0.15
71875828|NCT01178333|143270130|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.35||||0.78|TWO_SIDED|95.0|0.16|11.25|||Regression, Cox|||||11.25|0.16|0.78
71875829|NCT01178333|143270131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.38||||0.06|TWO_SIDED|95.0|0.98|5.79|||Regression, Cox|||||5.79|0.98|0.06
71875830|NCT01178333|143270131|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.91||||0.11|TWO_SIDED|95.0|0.87|4.21|||Regression, Cox|||||4.21|0.87|0.11
71875831|NCT01178333|143270132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.8||||0.001|TWO_SIDED|95.0|1.5|5.22|||Regression, Cox|||||5.22|1.50|0.001
71875832|NCT01178333|143270132|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.97||||0.02|TWO_SIDED|95.0|1.12|3.45|||Regression, Cox|||||3.45|1.12|0.02
71758561|NCT01285557|143019225|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1683|TWO_SIDED|95.0|0.66|1.08|||Log Rank|||S-1+Cisplatin and 5FU+Cisplatin were compared using the log-rank test. The hazard ratio was estimated using a Cox's regression approach and survival was summarized using Kaplan Meier estimates along with 2-sided 95% confidence intervals (CI) for the estimates.||1.08|0.66|0.1683
71875833|NCT01178333|143270135|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.72
71875834|NCT01178333|143270136|SUPERIORITY_OR_OTHER|||||||0.37|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.37
71875835|NCT01178333|143270137|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||0.02
71875836|NCT01178333|143270138|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||ANOVA|||||||0.58
71875837|NCT01178333|143270139|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
71875838|NCT01178333|143270140|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
71875839|NCT01178333|143270141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.48||||0.003|TWO_SIDED|95.0|1.35|4.55|||Regression, Cox|||||4.55|1.35|0.003
71875840|NCT01178333|143270141|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.07|TWO_SIDED|95.0|0.96|2.85|||Regression, Cox|||||2.85|0.96|0.07
71875841|NCT01178333|143270143|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||P-value is to compare three groups.|Chi-squared|||||||<0.01
71875842|NCT01178333|143270144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.72|TWO_SIDED|95.0|0.56|1.49|||Regression, Cox|||||1.49|0.56|0.72
71875843|NCT01178333|143270144|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.34|TWO_SIDED|95.0|0.54|1.24|||Regression, Cox|||||1.24|0.54|0.34
71875844|NCT01233869|143270145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.86|||<|0.0001|TWO_SIDED|95.0|2.02|5.74|||Mixed Models Analysis|||Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.||5.74|2.02|<0.0001
71875845|NCT01233869|143270145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.83||||0.1234|TWO_SIDED|95.0|-0.5|4.22|||Mixed Models Analysis|||Statistical Analysis 2 is comparison of annualized rate of kidney enlargement: bosutinib 200 mg/day versus bosutinib 400/200 mg/day.||4.22|-0.50|0.1234
71875846|NCT01233869|143270145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.06||||0.005|TWO_SIDED|95.0|0.93|5.23|||Mixed Models Analysis|||Statistical Analysis 3 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 200 mg/day.||5.23|0.93|0.0050
71875847|NCT01233869|143270145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|3.41||||0.1336|TWO_SIDED|95.0|-1.03|8.05|||Mixed Models Analysis|||Statistical Analysis 4 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400 mg/day.||8.05|-1.03|0.1336
71875848|NCT01233869|143270145|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.95|||<|0.0001|TWO_SIDED|95.0|2.65|7.3|||Mixed Models Analysis|||Statistical Analysis 5 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400/200 mg/day.||7.30|2.65|<0.0001
71875849|NCT00537485|143270170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|1.2||0.002|TWO_SIDED|95.0|-3.7|1.1|||t-test, 2 sided|||||1.1|-3.7|0.002
71875850|NCT00537485|143270171|SUPERIORITY_OR_OTHER||Risk Difference (RD)|30.7|||<|0.001|TWO_SIDED|95.0|16.7|44.6|||Chi-squared, Corrected|||||44.6|16.7|<0.001
71875851|NCT00537485|143270171|SUPERIORITY_OR_OTHER||Risk Difference (RD)|26.1|||<|0.001|TWO_SIDED|95.0|12.0|40.2|||Chi-squared, Corrected|||||40.2|12.0|<0.001
71875852|NCT02967354|143270180|SUPERIORITY|||||||0.5875||||||Treshold for significance P\<0.05|ANOVA|||||||0.5875
71875853|NCT02967354|143270181|SUPERIORITY|||||||0.0065||||||Treshold for significance P\<0.05|ANOVA|||||||0.0065
71875854|NCT02967354|143270182|SUPERIORITY|||||||0.0072||||||Treshold for significance P\<0.05|ANOVA|||||||0.0072
71875855|NCT02967354|143270183|SUPERIORITY|||||||0.9472||||||Treshold for significance P\<0.05|ANOVA|||||||0.9472
71875856|NCT02967354|143270184|SUPERIORITY|||||||0.0048||||||Treshold for significance P\<0.05|ANOVA|||||||0.0048
71875857|NCT01241552|143270185|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.7||||0.3182|TWO_SIDED|95.0|-8.6|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||5.5|-8.6|0.3182
71875858|NCT01241552|143270185|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.1||||0.0003|TWO_SIDED|95.0|-15.9|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-4.3|-15.9|0.0003
71875859|NCT01241552|143270185|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.6|||<|0.0001|TWO_SIDED|95.0|-17.4|-5.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-5.9|-17.4|< 0.0001
71875860|NCT01241552|143270185|SUPERIORITY_OR_OTHER||Adjusted Difference|-9.9||||0.0013|TWO_SIDED|95.0|-16.9|-3.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-3.4|-16.9|0.0013
71684062|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.3|STANDARD_ERROR_OF_MEAN|7.0||0.4514|TWO_SIDED|95.0|-19.1|8.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||8.6|-19.1|0.4514
71758562|NCT03173248|143019261|SUPERIORITY||Hazard Ratio (HR)|0.33||||0.0011|TWO_SIDED|95.0|0.16|0.69||P-value is calculated from the one-sided log-rank test stratified by the randomization stratification factors (AML status and geographic region).|Log Rank||Hazard ratio is estimated using a Cox's proportional hazards model stratified by the randomization stratification factors (AML status and geographic region) with placebo + azacitidine as the denominator.|||0.69|0.16|0.0011
71875861|NCT01241552|143270185|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.2997|TWO_SIDED|95.0|-6.7|3.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||3.9|-6.7|0.2997
71875862|NCT01241552|143270186|SUPERIORITY_OR_OTHER||Adjusted Difference|-8.3||||0.9775|TWO_SIDED|95.0|-16.3|-0.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||-0.2|-16.3|0.9775
71875863|NCT01241552|143270186|SUPERIORITY_OR_OTHER||Adjusted Difference|4.8||||0.0861|TWO_SIDED|95.0|-2.1|11.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||11.7|-2.1|0.0861
71875864|NCT01241552|143270186|SUPERIORITY_OR_OTHER||Adjusted Difference|3.5||||0.1646|TWO_SIDED|95.0|-3.5|10.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||10.4|-3.5|0.1646
71875865|NCT01241552|143270186|SUPERIORITY_OR_OTHER||Adjusted Difference|11.7||||0.0025|TWO_SIDED|95.0|3.5|19.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||19.7|3.5|0.0025
71875866|NCT01241552|143270186|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.4||||0.6532|TWO_SIDED|95.0|-8.3|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.5|-8.3|0.6532
71875867|NCT01241552|143270187|SUPERIORITY_OR_OTHER||Adjusted Difference|1.7||||0.6505|TWO_SIDED|95.0|-6.9|10.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC|||10.7|-6.9|0.6505
71875868|NCT01241552|143270187|SUPERIORITY_OR_OTHER||Adjusted Difference|-10.8||||0.0013|TWO_SIDED|95.0|-17.7|-3.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC|||-3.8|-17.7|0.0013
71875869|NCT01241552|143270187|SUPERIORITY_OR_OTHER||Adjusted Difference|-11.7||||0.0006|TWO_SIDED|95.0|-18.6|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-18.6|0.0006
71875870|NCT01241552|143270187|SUPERIORITY_OR_OTHER||Adjusted Difference|-13.7||||0.0007|TWO_SIDED|95.0|-22.5|-5.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC|||-5.2|-22.5|0.0007
71875871|NCT01241552|143270187|SUPERIORITY_OR_OTHER||Adjusted Difference|-1.0||||0.3906|TWO_SIDED|95.0|-7.7|5.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC|||5.8|-7.7|0.3906
71875872|NCT01241552|143270188|SUPERIORITY_OR_OTHER||Percentage Difference|5.2||||0.185|TWO_SIDED|95.0|-2.5|12.8|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||12.8|-2.5|0.185
71875873|NCT01241552|143270188|SUPERIORITY_OR_OTHER||Percentage Difference|3.4||||0.323|TWO_SIDED|95.0|-3.3|10.1|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.1|-3.3|0.323
71875874|NCT01241552|143270188|SUPERIORITY_OR_OTHER||Percentage Difference|-2.3||||0.507|TWO_SIDED|95.0|-9.1|4.5|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.5|-9.1|0.507
71875875|NCT01241552|143270189|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.246|TWO_SIDED|95.0|-1.5|6.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||6.7|-1.5|0.246
71875876|NCT01241552|143270189|SUPERIORITY_OR_OTHER||Percentage Difference|3.2||||0.069|TWO_SIDED|95.0|-0.3|6.8|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||6.8|-0.3|0.069
71916665|NCT01332851|143355082|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.06 (SE=.08) lower for PFR compared to R\&R group.|||||>.05
71922329|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccine Group Differences at Day 86|27.0|||||TWO_SIDED|97.5|16.9|37.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC||37.7|16.9|
71684063|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.212||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2120
71758563|NCT04701762|143019341|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|99.32|0.14|0.29|||GLM cumulative logit GEE model|||||0.29|0.14|<0.001
71758564|NCT04701762|143019342|SUPERIORITY||Risk Ratio (RR)|0.06|||<|0.001|TWO_SIDED|99.32|0.03|0.14|||Wilcoxon (Mann-Whitney)|||||0.14|0.03|<0.001
71875877|NCT01241552|143270189|SUPERIORITY_OR_OTHER||Percentage Difference|1.2||||0.464|TWO_SIDED|95.0|-2.1|4.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||4.6|-2.1|0.464
71875878|NCT01241552|143270190|SUPERIORITY_OR_OTHER||Percentage Difference|7.7||||0.027|TWO_SIDED|95.0|0.9|14.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||14.7|0.9|0.027
71875879|NCT01241552|143270190|SUPERIORITY_OR_OTHER||Percentage Difference|1.5||||0.594|TWO_SIDED|95.0|-4.1|7.2|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||7.2|-4.1|0.594
71875880|NCT01241552|143270190|SUPERIORITY_OR_OTHER||Percentage Difference|-5.3||||0.051|TWO_SIDED|95.0|-10.6|0.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||0.0|-10.6|0.051
71875881|NCT01241552|143270191|SUPERIORITY_OR_OTHER||Percentage Difference|1.0||||0.115|TWO_SIDED|95.0|-0.3|3.5|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-0.3|0.115
71875882|NCT01241552|143270191|SUPERIORITY_OR_OTHER||Percentage Difference|0.8||||0.17|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||2.4|-0.5|0.170
71875883|NCT01241552|143270191|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.544|TWO_SIDED|95.0|-0.9|1.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placeb + SOC|||1.6|-0.9|0.544
71875884|NCT01241552|143270192|SUPERIORITY_OR_OTHER||Percentage Difference|0.4||||0.192|TWO_SIDED|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||2.4|-0.5|0.192
71875885|NCT01241552|143270192|SUPERIORITY_OR_OTHER||Percentage Difference|0.3||||0.311|TWO_SIDED|95.0|-0.7|1.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-0.7|0.311
71875886|NCT01241552|143270192|SUPERIORITY_OR_OTHER||Percentage Difference|0.0|||>|0.999|TWO_SIDED|95.0|-1.0|1.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.0|-1.0|> 0.999
71875887|NCT01241552|143270193|SUPERIORITY_OR_OTHER||Percentage Difference|3.6|||||TWO_SIDED|95.0|-1.0|8.7|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.7|-1.0|
71875888|NCT01241552|143270193|SUPERIORITY_OR_OTHER||Percentage Difference|4.3|||||TWO_SIDED|95.0|0.2|8.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||8.5|0.2|
71875889|NCT01241552|143270193|SUPERIORITY_OR_OTHER||Percentage Difference|1.3|||||TWO_SIDED|95.0|-2.6|5.2|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||5.2|-2.6|
71875890|NCT01241552|143270194|SUPERIORITY_OR_OTHER||Percentage Difference|-6.9|||||TWO_SIDED|95.0|-16.8|3.5|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.5|-16.8|
71875891|NCT01241552|143270194|SUPERIORITY_OR_OTHER||Percentage Difference|-18.0|||||TWO_SIDED|95.0|-26.3|-9.6|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-9.6|-26.3|
71758565|NCT04701762|143019343|SUPERIORITY||Risk Ratio (RR)|0.87||||0.53|TWO_SIDED|99.32|0.48|1.58|||GLM log-binomial model (log link)|||||1.58|0.48|0.53
71758566|NCT04701762|143019344|SUPERIORITY||Mean Difference (Final Values)|2.0|||<|0.001|TWO_SIDED|95.0|0.92|3.1|||Mixed Models Analysis|||||3.1|0.92|<0.001
71758567|NCT04701762|143019345|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.27|TWO_SIDED|95.0|-0.34|1.2|||Mixed Models Analysis|||||1.2|-0.34|0.27
71875892|NCT01241552|143270194|SUPERIORITY_OR_OTHER||Percentage Difference|-16.2|||||TWO_SIDED|95.0|-24.5|-7.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-7.7|-24.5|
71875893|NCT01241552|143270195|SUPERIORITY_OR_OTHER||Percentage Difference|-6.1|||||TWO_SIDED|95.0|-20.1|8.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||8.6|-20.1|
71875894|NCT01241552|143270195|SUPERIORITY_OR_OTHER||Percentage Difference|-13.2|||||TWO_SIDED|95.0|-25.5|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-25.5|
71875895|NCT01241552|143270195|SUPERIORITY_OR_OTHER||Percentage Difference|-14.4|||||TWO_SIDED|95.0|-26.8|-1.6|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-1.6|-26.8|
71875896|NCT01241552|143270196|SUPERIORITY_OR_OTHER||Percentage Difference|0.8|||||TWO_SIDED|95.0|-16.9|21.0|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||21.0|-16.9|
71875897|NCT01241552|143270196|SUPERIORITY_OR_OTHER||Percentage Difference|-14.6|||||TWO_SIDED|95.0|-28.3|-1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-1.4|-28.3|
71875898|NCT01241552|143270196|SUPERIORITY_OR_OTHER||Percentage Difference|-12.1|||||TWO_SIDED|95.0|-26.2|1.9|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||1.9|-26.2|
71875899|NCT01241552|143270197|SUPERIORITY_OR_OTHER||Percentage Difference|-10.0|||||TWO_SIDED|95.0|-30.1|10.0|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||10.0|-30.1|
71875900|NCT01241552|143270197|SUPERIORITY_OR_OTHER||Percentage Difference|-25.3|||||TWO_SIDED|95.0|-43.7|-6.1|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-6.1|-43.7|
71875901|NCT01241552|143270198|SUPERIORITY_OR_OTHER||Percentage Difference|-11.3|||||TWO_SIDED|95.0|-24.9|3.9|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||3.9|-24.9|
71875902|NCT01241552|143270198|SUPERIORITY_OR_OTHER||Percentage Difference|-12.7|||||TWO_SIDED|95.0|-24.7|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||-0.5|-24.7|
71875903|NCT01241552|143270198|SUPERIORITY_OR_OTHER||Percentage Difference|-16.0|||||TWO_SIDED|95.0|-27.8|-4.0|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.0|-27.8|
71875904|NCT01241552|143270199|SUPERIORITY_OR_OTHER||Percentage Difference|-10.1|||||TWO_SIDED|95.0|-23.2|4.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC|||4.6|-23.2|
71875905|NCT01241552|143270199|SUPERIORITY_OR_OTHER||Percentage Difference|-11.0|||||TWO_SIDED|95.0|-23.2|1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC|||1.4|-23.2|
71684064|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1057||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1057
71684065|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5241||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5241
71684066|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2773||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2773
71684067|NCT04015518|142886306|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.3867||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.3867
71684068|NCT04015518|142886307|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-6.1|STANDARD_ERROR_OF_MEAN|6.7|||TWO_SIDED|95.0|-19.3|7.1|||||Difference was calculated as Speso - placebo.|||7.1|-19.3|
71684069|NCT04015518|142886307|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|6.8|||TWO_SIDED|95.0|-18.8|8.0|||||Difference was calculated as Speso - placebo.|||8.0|-18.8|
71684070|NCT04015518|142886307|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-3.5|STANDARD_ERROR_OF_MEAN|6.6|||TWO_SIDED|95.0|-16.6|9.7|||||Difference was calculated as Speso - placebo.|||9.7|-16.6|
71684071|NCT04015518|142886307|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-9.4|STANDARD_ERROR_OF_MEAN|5.5|||TWO_SIDED|95.0|-20.3|1.4|||||Difference was calculated as Speso - placebo.|||1.4|-20.3|
71875906|NCT01241552|143270199|SUPERIORITY_OR_OTHER||Percentage Difference|-16.7|||||TWO_SIDED|95.0|-28.4|-4.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC|||-4.7|-28.4|
71875907|NCT01158651|143270200|SUPERIORITY|The treatment regimen was considered promising for further study if after 48 weeks of treatment there was at least a 25% response rate compared to an expected response rate of 5% or less, which was considered evidence of an unpromising regimen. Assuming the true response rate is 5%, the binomial distribution was used to calculate Type I errors and power.|Proportion responding|0.682|||<|0.001|TWO_SIDED|95.0|0.4872|0.8764|||Exact test|||||0.8764|0.4872|<0.001
71875908|NCT05696236|143270269|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|||||||0.77
71875909|NCT05696236|143270270|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||||||0.07
71875910|NCT05696236|143270271|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71875911|NCT05341700|143270273|SUPERIORITY|||||||0.246|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of PINP between RUN and RUN+J.||||0.246
71875912|NCT05341700|143270274|SUPERIORITY|||||||0.714|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of CTX between RUN and RUN+J.||||0.714
71875913|NCT05341700|143270275|SUPERIORITY|||||||0.309|||||||Mixed Models Analysis|||||||0.309
71684072|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.1|STANDARD_ERROR_OF_MEAN|6.9||0.5595|TWO_SIDED|95.0|-17.7|9.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.6|-17.7|0.5595
71684073|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|0.9|STANDARD_ERROR_OF_MEAN|6.9||0.8968|TWO_SIDED|95.0|-12.7|14.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||14.5|-12.7|0.8968
71875914|NCT05341700|143270276|SUPERIORITY|||||||0.308|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of IGF1 between RUN and RUN+J.||||0.308
71875915|NCT05341700|143270277|SUPERIORITY|||||||0.207|||||||Mixed Models Analysis|||Null hypothesis is that there was no difference in change of ferritin between RUN and RUN+J.||||0.207
71875916|NCT02378220|143270283|OTHER||Risk Ratio (RR)|0.65||||0.21|TWO_SIDED|95.0|0.32|1.28||P-value for 30 days measure.|Regression, Poisson|||||1.28|0.32|0.21
71875917|NCT02378220|143270283|OTHER||Risk Ratio (RR)|0.48||||0.007|TWO_SIDED|95.0|0.27|0.82||P-Value for 60 days measure|Regression, Poisson|||||0.82|0.27|0.007
71758568|NCT04922216|143019379|SUPERIORITY||Mean Difference (Net)|0.3||||0.52|TWO_SIDED|95.0|-0.61|1.2|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 6 months).||1.20|-0.61|0.52
71875918|NCT02378220|143270284|OTHER||Risk Ratio (RR)|0.62||||0.16|TWO_SIDED|95.0|0.31|1.21||P-Value for 30 days measure|Regression, Poisson|||||1.21|0.31|0.16
71875919|NCT02378220|143270284|OTHER||Risk Ratio (RR)|0.58||||0.045|TWO_SIDED|95.0|0.34|0.99|||Regression, Poisson|||||0.99|0.34|0.045
71875920|NCT02378220|143270285|OTHER||Hazard Ratio (HR)|0.59||||0.1|TWO_SIDED|95.0|0.31|1.12|||Log Rank|||||1.12|0.31|0.10
71875921|NCT02378220|143270286|OTHER||Hazard Ratio (HR)|0.6||||0.09|TWO_SIDED|95.0|0.33|1.1|||Log Rank|||||1.10|0.33|0.09
71875922|NCT00312221|143270297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38||||0.126|TWO_SIDED|95.0|-0.8562|0.1054|||Mixed Models Analysis||Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase|||0.1054|-0.8562|0.126
71875923|NCT00312221|143270297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.14||95.0|-0.8455|0.1189|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.1189|-0.8455|0.140
71875924|NCT00312221|143270298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.007|TWO_SIDED|95.0|-1.47|-0.2|||ANCOVA||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||-0.20|-1.47|0.007
71875925|NCT00312221|143270298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.011|TWO_SIDED|95.0|-1.47|-0.17|||ANCOVA||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||-0.17|-1.47|0.011
71875926|NCT00312221|143270299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.707|TWO_SIDED|95.0|-3.0054|2.0397|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||2.0397|-3.0054|0.707
71875927|NCT00312221|143270299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.187|TWO_SIDED|95.0|-4.4459|0.8706|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||0.8706|-4.4459|0.187
71916666|NCT01332851|143355083|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||The PFR group had lower atypical affective communication compared to the R\&R group (the absolute value of the standardized effect size was d=.19).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R\&R = 0, PFR = 1), baseline score, months between baseline and end of intervention, and age of child at baseline||||<.05
71916667|NCT00255008|143355088|SUPERIORITY_OR_OTHER||Proportion of patients (%)|80.0||||||95.0|28.36|99.49||||||||99.49|28.36|
71916668|NCT00255008|143355088|SUPERIORITY_OR_OTHER||Proportion of patients (%)|76.47||||||95.0|50.1|93.19||||||||93.19|50.10|
71916669|NCT00255008|143355088|SUPERIORITY_OR_OTHER||Proportion of patients (%)|87.5||||||95.0|47.35|99.48||||||||99.48|47.35|
71875928|NCT00312221|143270300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.685|TWO_SIDED|95.0|-5.6177|3.693|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.|||3.6930|-5.6177|0.685
71875929|NCT00312221|143270300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81||||0.443|TWO_SIDED|95.0|-6.4415|2.8255|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.|||2.8255|-6.4415|0.443
71875930|NCT00846885|143270347|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||117|103|
71875931|NCT00846885|143270348|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|106.0||||||90.0|102.0|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||111|102|
71875932|NCT00846885|143270349|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|101.0|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||110|101|
71875933|NCT01862640|143270350|SUPERIORITY||Least square (LS) mean difference|-3.77|||=|0.0404|TWO_SIDED|95.0|-7.38|-0.17|||Mixed-effect model repeated measure|||||-0.17|-7.38|=0.0404
71875934|NCT01862640|143270350|SUPERIORITY||LS mean difference|0.23|||=|0.9015|TWO_SIDED|95.0|-3.4|3.86|||Mixed-effect model repeated measure|||||3.86|-3.40|=0.9015
71875935|NCT01862640|143270351|SUPERIORITY||LS mean difference|-0.16|||=|0.1566|TWO_SIDED|95.0|-0.39|0.06|||Mixed-effect model repeated measure|||||0.06|-0.39|=0.1566
71875936|NCT01862640|143270351|SUPERIORITY||LS mean difference|0.09|||=|0.444|TWO_SIDED|95.0|-0.14|0.32|||Mixed-effect model repeated measure|||||0.32|-0.14|=0.4440
71916670|NCT01833806|143355089|SUPERIORITY||Proportion Difference|0.78|||=|0.01|TWO_SIDED|95.0|0.58|0.98|||Binomial|||The alternative hypothesis test was that the proportion of Responders would be greater than the proportion of subjects experiencing pain progression. This PAS was powered to enroll 70 subjects based on the pivotal trial proportion of 18:8 (Responders:Pain progression). The study was closed at an enrollment of 32 subjects.||0.98|0.58|= 0.01
71916671|NCT02724111|143355092|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71916672|NCT02724111|143355093|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71916673|NCT02724111|143355094|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71916674|NCT02724111|143355095|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71916675|NCT02724111|143355096|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71684074|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-4.2|STANDARD_ERROR_OF_MEAN|6.9||0.5456|TWO_SIDED|95.0|-17.9|9.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||9.5|-17.9|0.5456
71684075|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-7.7|STANDARD_ERROR_OF_MEAN|5.7||0.1762|TWO_SIDED|95.0|-19.0|3.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||3.5|-19.0|0.1762
71684076|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1726||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1726
71684077|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2353||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2353
71684078|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1346||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1346
71758569|NCT04922216|143019379|SUPERIORITY||Mean Difference (Net)|-0.28||||0.54|TWO_SIDED|95.0|-1.19|0.63|||Mixed Models Analysis|Degrees of freedom (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||0.63|-1.19|0.54
71875937|NCT04884763|143270352|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.567|TWO_SIDED|95.0|-0.76|1.35||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.35|-0.76|0.567
71875938|NCT04884763|143270353|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.778|TWO_SIDED|95.0|-0.91|1.21||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.21|-0.91|0.778
71875939|NCT04884763|143270354|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.105|TWO_SIDED|95.0|-0.2|1.96||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.96|-0.20|0.105
71875940|NCT04884763|143270355|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.163|TWO_SIDED|95.0|-7.6|42.7||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||42.7|-7.6|0.163
71875941|NCT04884763|143270356|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.91|TWO_SIDED|95.0|-1.13|1.01||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.01|-1.13|0.910
71875942|NCT04884763|143270357|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.972|TWO_SIDED|95.0|-0.83|0.8||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.80|-0.83|0.972
71875943|NCT04884763|143270358|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.037|TWO_SIDED|95.0|0.18|5.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.43|0.18|0.037
71875944|NCT04884763|143270359|SUPERIORITY||Mean Difference (Final Values)|-0.26||||0.885|TWO_SIDED|95.0|-3.95|3.43||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||3.43|-3.95|0.885
71875945|NCT04884763|143270360|SUPERIORITY||Mean Difference (Final Values)|0.47||||0.474|TWO_SIDED|95.0|-0.87|1.81||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.81|-0.87|0.474
71875946|NCT04884763|143270361|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.822|TWO_SIDED|95.0|-1.94|1.56||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.56|-1.94|0.822
71875947|NCT04884763|143270362|SUPERIORITY||Mean Difference (Final Values)|0.51||||0.455|TWO_SIDED|95.0|-0.88|1.91||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.91|-0.88|0.455
71875948|NCT04884763|143270363|SUPERIORITY||Mean Difference (Final Values)|7.1||||0.467|TWO_SIDED|95.0|-12.8|27.0||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||27.0|-12.8|0.467
71875949|NCT04884763|143270364|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.755|TWO_SIDED|95.0|-0.79|1.07||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||1.07|-0.79|0.755
71875950|NCT04884763|143270365|SUPERIORITY||Mean Difference (Final Values)|-0.23||||0.613|TWO_SIDED|95.0|-1.18|0.71||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||0.71|-1.18|0.613
71875951|NCT04884763|143270366|SUPERIORITY||Mean Difference (Final Values)|2.58||||0.003|TWO_SIDED|95.0|0.94|4.22||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||4.22|0.94|0.003
71875952|NCT04884763|143270367|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.536|TWO_SIDED|95.0|-2.7|5.08||A two-sided 5% significance level was used for all tests without multiplicity adjustment between multiple endpoints.|Mixed Models Analysis|Model included factors for treatment group, time, and their interaction, with time repeated within subject. Gender as a covariate.|For difference calculation, Arm A - Arm B|Based on two-sided paired t-tests and two-sample t-tests, all conducted at a 5% significance level, this pilot study had 80% power to detect effect sizes of 0.9 for changes over time within groups and effect sizes of 1.2 for differences between groups. To account for dropout, the study enrolled 15 patients per group, for a total of 30 patients.||5.08|-2.70|0.536
71916676|NCT02724111|143355097|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71916677|NCT02724111|143355098|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71916678|NCT02724111|143355099|SUPERIORITY|||||||0.202|||||||Chi-squared|||||||0.202
71916679|NCT02996500|143355100|SUPERIORITY||Mean Difference (Net)|-7.83||||0.005|TWO_SIDED|95.0|-13.73|-1.97|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-1.97|-13.73|0.0050
71916680|NCT02996500|143355100|SUPERIORITY||Mean Difference (Net)|-8.96|||<|0.001|TWO_SIDED|95.0|-14.37|-3.66|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-3.66|-14.37|<0.001
71916681|NCT02996500|143355100|SUPERIORITY||Median Difference (Net)|-10.89|||<|0.001|TWO_SIDED|95.0|-16.36|-5.63|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.63|-16.36|<0.001
71916682|NCT02996500|143355100|SUPERIORITY||Mean Difference (Net)|-11.29|||<|0.001|TWO_SIDED|95.0|-16.62|-5.92|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.||-5.92|-16.62|<0.001
71875953|NCT02178553|143270368|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.142|TWO_SIDED|90.0|-0.1|1.8|||t-test, 2 sided|||||1.8|-0.1|0.142
71916683|NCT01828567|143355134|OTHER|A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.|Odds Ratio (OR)|2.54|||<|0.0001|TWO_SIDED|95.0|1.66|3.89|||Regression, Logistic|||The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.||3.89|1.66|<.0001
71916684|NCT01828567|143355136|OTHER||Mean Difference (Final Values)|1.5||||0.204|TWO_SIDED|95.0|-0.8|3.7||A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.|For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.||3.7|-0.8|0.204
71916685|NCT01828567|143355137|EQUIVALENCE|This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.|Mean Difference (Final Values)|2.5||||0.03|TWO_SIDED|95.0|0.2|4.7||A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.|||4.7|0.2|0.030
71916686|NCT01828567|143355139|EQUIVALENCE|This model assumes the groups have equal baseline means|Mean Difference (Final Values)|0.7||||0.33|TWO_SIDED|95.0|-0.7|2.2|||Repeated Measures|A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.|Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.||2.2|-0.7|0.330
71916687|NCT00959699|143355142|SUPERIORITY_OR_OTHER||Strata-Adjusted Difference|33.7||||0.0008|TWO_SIDED|95.0|14.1|53.3||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) was not possible due to sparse data.||53.3|14.1|0.0008
71684079|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.195||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1950
71684080|NCT04015518|142886308|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.1681||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1681
71875954|NCT02178553|143270369|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.101|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.101
71875955|NCT02178553|143270370|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.014|TWO_SIDED|90.0|0.4|1.9|||t-test, 2 sided|||||1.9|0.4|0.014
71875956|NCT02178553|143270371|NON_INFERIORITY|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.375|TWO_SIDED|90.0|-0.3|1.0|||t-test, 2 sided|||||1.0|-0.3|0.375
71684081|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2812|TWO_SIDED|95.0|-1.8|0.5|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.5|-1.8|0.2812
71684082|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3357|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.6|-1.7|0.3357
71684083|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.8|STANDARD_ERROR_OF_MEAN|0.6||0.1809|TWO_SIDED|95.0|-2.0|0.4|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.4|-2.0|0.1809
71875957|NCT01807923|143270437|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.03|||<|0.0001|TWO_SIDED|95.0|2.62|5.44|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than (\<)18 versus greater than equal to (\>=18) years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||5.44|2.62|<0.0001
71875958|NCT01807923|143270437|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6||||0.0003|TWO_SIDED|95.0|1.18|4.01|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.01|1.18|0.0003
71875959|NCT01807923|143270438|SUPERIORITY_OR_OTHER||LS Mean Difference|6.73|||<|0.0001|TWO_SIDED|95.0|4.27|9.19|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||9.19|4.27|<0.0001
71875960|NCT01807923|143270438|SUPERIORITY_OR_OTHER||LS Mean Difference|4.33||||0.0006|TWO_SIDED|95.0|1.86|6.8|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||6.80|1.86|0.0006
71875961|NCT01807923|143270439|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.1122|TWO_SIDED|95.0|-0.04|0.35|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI.||0.35|-0.04|0.1122
71875962|NCT01807923|143270439|SUPERIORITY_OR_OTHER||LS Mean Difference|0.13||||0.1938|TWO_SIDED|95.0|-0.07|0.32|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||0.32|-0.07|0.1938
71916688|NCT00959699|143355143|SUPERIORITY_OR_OTHER||Observed Difference|34.2||||0.0007|TWO_SIDED|95.0|14.5|53.9||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (\< or \>= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution||53.9|14.5|0.0007
71916689|NCT00835276|143355148|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|87.96||||||90.0|80.15|96.53|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||96.53|80.15|
71916690|NCT00835276|143355149|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.15|98.26|||||To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.|||98.26|85.15|
71916691|NCT00835276|143355150|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.32|98.07|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.|||98.07|85.32|
71916692|NCT02485860|143355151|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71684084|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-0.1|STANDARD_ERROR_OF_MEAN|0.5||0.8322|TWO_SIDED|95.0|-1.1|0.9|||Mixed Models Analysis|Kenward-Roger was used to estimate denominator degrees of freedom.|Difference was calculated as Speso - placebo.|||0.9|-1.1|0.8322
71684085|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4035||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4035
71684086|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.2563||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.2563
71684087|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.681||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.6810
71684088|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.4665||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.4665
71684089|NCT04015518|142886309|OTHER|Mixed-effects Model Repeated Measures (MMRM) estimates were used as input for the MCP-Mod. MMRM included'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.||||||0.5565||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.5565
71875963|NCT01807923|143270440|SUPERIORITY_OR_OTHER||LS Mean Difference|3.88||||0.0168|TWO_SIDED|95.0|0.7|7.05||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline CFQ-R respiratory domain score.||7.05|0.70|0.0168
71875964|NCT01807923|143270440|SUPERIORITY_OR_OTHER||LS Mean Difference|1.5||||0.3569|TWO_SIDED|95.0|-1.69|4.69|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.||4.69|-1.69|0.3569
71875965|NCT01807923|143270441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9378|||<|0.0001|TWO_SIDED|95.0|1.8786|4.5941||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||4.5941|1.8786|<0.0001
71875966|NCT01807923|143270441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0592||||0.0023|TWO_SIDED|95.0|1.292|3.2819||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||3.2819|1.2920|0.0023
71875967|NCT01807923|143270442|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.7186||||0.0491|TWO_SIDED|95.0|0.517|0.9987|||Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70) as covariates with the logarithm of time on study as the offset.||0.9987|0.5170|0.0491
71684090|NCT04015518|142886310|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.042|||||TWO_SIDED|95.0|-0.17|0.281|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.281|-0.170|
71684091|NCT04015518|142886310|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.195|||||TWO_SIDED|95.0|-0.048|0.432|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.432|-0.048|
71684092|NCT04015518|142886310|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.27|||||TWO_SIDED|95.0|0.02|0.496|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.496|0.020|
71684093|NCT04015518|142886310|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.129|||||TWO_SIDED|95.0|-0.067|0.314|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.314|-0.067|
71684094|NCT04015518|142886310|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0613||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0613
71684095|NCT04015518|142886310|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0628||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0628
71684096|NCT04015518|142886310|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1449||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1449
71875968|NCT01807923|143270442|SUPERIORITY_OR_OTHER||Event Rate Ratio|0.6643||||0.0169|TWO_SIDED|95.0|0.4749|0.9291||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.||0.9291|0.4749|0.0169
71875969|NCT01807923|143270443|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.1565|TWO_SIDED|95.0|-0.16|0.96|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline weight.||0.96|-0.16|0.1565
71875970|NCT01807923|143270443|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.2992|TWO_SIDED|95.0|-0.26|0.86|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.86|-0.26|0.2992
71875971|NCT01807923|143270444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.1539|TWO_SIDED|95.0|-0.037|0.233|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline BMI z-score.||0.2330|-0.0370|0.1539
71875972|NCT01807923|143270444|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0781||||0.2713|TWO_SIDED|95.0|-0.0615|0.2176|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.2176|-0.0615|0.2713
71684097|NCT04015518|142886310|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.046||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0460
71684098|NCT04015518|142886310|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0677||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0677
71684099|NCT04015518|142886311|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.063|||||TWO_SIDED|95.0|-0.069|0.256|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.256|-0.069|
71684100|NCT04015518|142886311|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.188|||||TWO_SIDED|95.0|0.018|0.405|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.405|0.018|
71684101|NCT04015518|142886311|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.102|||||TWO_SIDED|95.0|-0.042|0.303|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.303|-0.042|
71684102|NCT04015518|142886311|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.113|||||TWO_SIDED|95.0|-0.018|0.25|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.250|-0.018|
71684103|NCT04015518|142886311|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0536||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0536
71758570|NCT04922216|143019379|SUPERIORITY||Mean Difference (Net)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.31|||Mixed Models Analysis|Degrees of freedom (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 6 months).||1.31|-0.50|0.39
71916693|NCT03325010|143355152|SUPERIORITY||Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.5||0.1768|TWO_SIDED|95.0|-5.2|1.0||Nominal p-value is considered statistically significant if less than 0.05. To control for multiplicity, comparisons were tested sequentially.|Mixed Models Analysis|||||1.0|-5.2|0.1768
71916694|NCT03325010|143355153|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1095|TWO_SIDED|95.0|-0.6|0.1||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary outcome measure was statistically significant.|Mixed Models Analysis|||||0.1|-0.6|0.1095
71916695|NCT03325010|143355154|SUPERIORITY||Risk Difference (RD)|3.0||||0.819|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg).||||||0.8190
71684104|NCT04015518|142886311|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0476||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0476
71684105|NCT04015518|142886311|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.1076||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.1076
71684106|NCT04015518|142886311|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0606||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0606
71684107|NCT04015518|142886311|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0824||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0824
71684108|NCT04015518|142886312|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.211|||||TWO_SIDED|95.0|0.04|0.422|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.422|0.040|
71684109|NCT04015518|142886312|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.13|||||TWO_SIDED|95.0|-0.018|0.339|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.339|-0.018|
71875973|NCT01807923|143270445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.692||||0.0396|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||||0.0396
71875974|NCT01807923|143270445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.691||||0.0385|TWO_SIDED||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.||||0.0385
71875975|NCT01807923|143270446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6565||||0.0552|TWO_SIDED|95.0|0.4266|1.0103|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (\<18 versus \>=18 years old), and percent predicted FEV1 severity at Screening (\<70 versus \>=70).||1.0103|0.4266|0.0552
71875976|NCT01807923|143270446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6438||||0.0512|TWO_SIDED|95.0|0.4142|1.0005|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.||1.0005|0.4142|0.0512
71875977|NCT01807923|143270447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.5604|TWO_SIDED|95.0|-0.0142|0.0262|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L index score.||0.0262|-0.0142|0.5604
71875978|NCT01807923|143270447|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0095||||0.3613|TWO_SIDED|95.0|-0.0109|0.0298|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||0.0298|-0.0109|0.3613
71684110|NCT04015518|142886312|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.125|||||TWO_SIDED|95.0|-0.022|0.328|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.328|-0.022|
71684111|NCT04015518|142886312|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.144|||||TWO_SIDED|95.0|0.009|0.282|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.282|0.009|
71684112|NCT04015518|142886312|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0333||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0333
71875979|NCT01807923|143270448|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.1342|TWO_SIDED|95.0|-0.7|4.9|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline EQ-5D-3L VAS score.||4.9|-0.7|0.1342
71875980|NCT01807923|143270448|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4||||0.3071|TWO_SIDED|95.0|-1.3|4.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.||4.2|-1.3|0.3071
71916696|NCT03325010|143355155|SUPERIORITY||Risk Difference (RD)|33.6||||0.0008|TWO_SIDED|||||To control for multiplicity, comparisons were tested sequentially. Nominal p-value for this outcome measure would only be evaluated for statistical significance if the primary and preceding secondary outcome measures were statistically significant.|Cochran-Mantel-Haenszel|Stratified by baseline weight group (\<50 kg, ≥50 kg)||||||0.0008
71916697|NCT02402881|143355156|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
71916698|NCT02402881|143355157|OTHER||Odds Ratio (OR)|1.0|||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.||||<0.05
71916699|NCT00460525|143355167|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.17||||0.175||95.0|-0.09|0.37||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|No adjustments were made.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first clinical malaria episode with significant parasitemia (2500/mm\^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.09|0.175
71916700|NCT00460525|143355169|SUPERIORITY_OR_OTHER||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.2||||0.068||95.0|-0.02|0.37||The a priori threshold for statistical significance was set at 0.05.|Poisson regression|No adjustments|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.|Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.||0.37|-0.02|0.068
71916701|NCT03073200|143355184|SUPERIORITY||Mean Difference (Final Values)|63.7|||<|0.001|TWO_SIDED|95.0|51.0|76.4|||Fisher Exact|||||76.4|51.0|<0.001
71916702|NCT03073200|143355185|SUPERIORITY||Mean Difference (Final Values)|70.2|||<|0.001|TWO_SIDED|95.0|59.3|81.0|||Fisher Exact|||||81|59.3|<0.001
71916703|NCT03073200|143355186|SUPERIORITY||Mean Difference (Final Values)|72.9|||<|0.001|TWO_SIDED|95.0|63.3|82.5|||Fisher Exact|||||82.5|63.3|<0.001
71916704|NCT03073200|143355187|SUPERIORITY||Mean Difference (Final Values)|50.4|||<|0.001|TWO_SIDED|95.0|40.6|60.2|||Fisher Exact|||||60.2|40.6|<0.001
71916705|NCT03073200|143355188|SUPERIORITY||Mean Difference (Final Values)|47.8|||<|0.001|TWO_SIDED|95.0|38.0|57.6|||Fisher Exact|||||57.6|38.0|<0.001
71916706|NCT03073200|143355189|SUPERIORITY||Mean Difference (Final Values)|45.0|||<|0.001|TWO_SIDED|95.0|33.2|56.8|||Fisher Exact|||||56.8|33.2|<0.001
71916707|NCT03073200|143355190|SUPERIORITY||Mean Difference (Final Values)|40.7|||<|0.001|TWO_SIDED|95.0|29.3|52.0|||Fisher Exact|||||52.0|29.3|<0.001
71916708|NCT03073200|143355191|SUPERIORITY||Mean Difference (Final Values)|51.1|||<|0.001|TWO_SIDED|95.0|35.3|66.9|||Fisher Exact|||||66.9|35.3|<0.001
71875981|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.016|TWO_SIDED|95.0|1.03|9.96|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM effectiveness score.||9.96|1.03|0.0160
71875982|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|5.8||||0.0126|TWO_SIDED|95.0|1.25|10.35|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.||10.35|1.25|0.0126
71875983|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.18||||0.0074|TWO_SIDED|95.0|-7.23|-1.13|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM side effects score.||-1.13|-7.23|0.0074
71875984|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.74||||0.0029|TWO_SIDED|95.0|-7.85|-1.63|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.||-1.63|-7.85|0.0029
71875985|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|0.61||||0.7721|TWO_SIDED|95.0|-3.5|4.71|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM convenience score.||4.71|-3.50|0.7721
71875986|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|3.08||||0.1472|TWO_SIDED|95.0|-1.09|7.25|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.||7.25|-1.09|0.1472
71875987|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|5.49||||0.0345|TWO_SIDED|95.0|0.4|10.58|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (\<18 versus \>=18 years old), percent predicted FEV1 severity at Screening (\<70 versus \>=70), and baseline TSQM global satisfaction score.||10.58|0.40|0.0345
71875988|NCT01807923|143270449|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.0109|TWO_SIDED|95.0|1.55|11.89|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.||11.89|1.55|0.0109
71875989|NCT02558231|143270454|SUPERIORITY||Ratio of geometric Least Square mean|0.96||||0.4239|TWO_SIDED|95.0|0.86|1.07|||ANCOVA|||||1.07|0.86|0.4239
71916709|NCT03073200|143355192|SUPERIORITY||Mean Difference (Final Values)|41.1|||<|0.001|TWO_SIDED|95.0|27.0|55.2|||Fisher Exact|||||55.2|27.0|<0.001
71916710|NCT03073200|143355193|SUPERIORITY||Mean Difference (Final Values)|-17.04|STANDARD_ERROR_OF_MEAN|5.747||0.005|TWO_SIDED|95.0|-28.7|-5.38|||Mixed Models Analysis|||||-5.38|-28.70|0.005
71916711|NCT03073200|143355194|SUPERIORITY||Mean Difference (Final Values)|-15.36|STANDARD_ERROR_OF_MEAN|1.682|<|0.001|TWO_SIDED|95.0|-18.69|-12.04|||Mixed Models Analysis|||||-12.04|-18.69|<0.001
71875990|NCT02558231|143270455|SUPERIORITY||Least Square (LS) Mean difference|-1.43||||0.8758|TWO_SIDED|95.0|-19.393|16.538|||ANCOVA|||||16.538|-19.393|0.8758
71875991|NCT02558231|143270456|SUPERIORITY||Ratio of geometric LS mean|1.03||||0.8529|TWO_SIDED|95.0|0.77|1.371|||ANCOVA|||||1.371|0.770|0.8529
71875992|NCT02558231|143270458|SUPERIORITY||LS Mean Difference|-0.72||||0.4998|TWO_SIDED|95.0|-2.834|1.386|||ANCOVA|||||1.386|-2.834|0.4998
71875993|NCT02558231|143270459|SUPERIORITY||LS Mean Difference|-0.09||||0.8528|TWO_SIDED|95.0|-1.003|0.83|||ANCOVA|||||0.830|-1.003|0.8528
71875994|NCT02558231|143270460|SUPERIORITY||LS Mean Difference|2.4||||0.9474|TWO_SIDED|95.0|-69.368|74.178|||ANCOVA|||||74.178|-69.368|0.9474
71875995|NCT02558231|143270461|SUPERIORITY||LS Mean Difference|0.13||||0.1902|TWO_SIDED|95.0|-0.066|0.328|||ANCOVA|||||0.328|-0.066|0.1902
71875996|NCT02558231|143270462|SUPERIORITY||LS Mean Difference|-1.2||||0.1227|TWO_SIDED|95.0|-2.737|0.327|||ANCOVA|||||0.327|-2.737|0.1227
71875997|NCT02558231|143270463|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0867|TWO_SIDED|95.0|0.32|1.09|||Log Rank|||||1.09|0.32|0.0867
71875998|NCT04029961|143270470|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
71875999|NCT04029961|143270471|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
71876000|NCT04029961|143270472|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
71916712|NCT03073200|143355195|SUPERIORITY||Mean Difference (Final Values)|-12.01|STANDARD_DEVIATION|3.853||0.006|TWO_SIDED|95.0|-20.11|-3.9|||Mixed Models Analysis|||||-3.90|-20.11|0.006
71876001|NCT04029961|143270473|OTHER|Multivariate regression model and intra-arm differences in measure scores between time points.|||||<|0.05||||||Multivariate regression was adjusted for covariates of study site, highest education level, prior chemotherapy, age, \& T stage. Random effects was adjusted for multiple measurements. Multiplicity corrections were conducted via Holm-Sidak method.|multivariate regression|||||||<0.05
71916713|NCT03073200|143355198|SUPERIORITY||Mean Difference (Final Values)|20.9||||0.089|TWO_SIDED|95.0|0.1|41.7|||Fisher Exact|||||41.7|0.1|0.089
71916714|NCT03073200|143355199|SUPERIORITY||Mean Difference (Final Values)|23.0||||0.07|TWO_SIDED|95.0|0.6|45.4|||Fisher Exact|||||45.4|0.6|0.070
71916715|NCT04757376|143355200|EQUIVALENCE|Statistical equivalence: the 90% confidence interval (CI) of the difference in the mean of the primary efficacy endpoint between treatment groups was entirely within an equivalence margin, \[- 1.45, + 1.45\].|Mean Difference (Final Values)|-0.19|||||TWO_SIDED|90.0|-0.76|0.38|||ANCOVA|ANCOVA included the treatment as a fixed effect and age, baseline LS-BMD T-score, and prior bisphosphonates therapy (Yes versus No) as covariates.||||0.38|-0.76|
71684113|NCT04015518|142886312|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0221||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regime"||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0221
71684114|NCT04015518|142886312|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0707||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0707
71684115|NCT04015518|142886312|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0578||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0578
71876002|NCT04029961|143270474|OTHER|"A univariate analysis comparing the proportion of each arm that indicated an item was met, evaluated for each item at each time point."|||||<|0.05|||||||Univariate analysis|||"The statistical test described below was only performed on the top 10 items on the scale rated the highest in importance by participants. The top 10 items were determined by computing the mean rating for each item (participants gave each item a rating from '1' - '9' with higher values representing greater importance) and selecting the 10 items with the largest mean values, excluding the item the radiation oncologist who will be treating me as that item was not addressed in either intervention."||||<0.05
71876003|NCT04252287|143270505|SUPERIORITY||LS mean difference|4.3||||0.016|TWO_SIDED|95.0|0.8|7.8|||ANCOVA|||||7.8|0.8|0.016
71876004|NCT04252287|143270506|SUPERIORITY||LS mean difference|29.8||||0.852|TWO_SIDED|95.0|-284.4|344.1|||ANCOVA|||||344.1|-284.4|0.852
71876005|NCT02273726|143270520|NON_INFERIORITY|Non-inferiority was established if the 2-sided 95% confidence interval (CI) for the treatment difference in least square (LS) means from MI ANCOVA model between the 2 treatment groups lay entirely above -0.75 g/dL.|LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.058|<|0.0001|TWO_SIDED|95.0|0.365|0.591|||ANCOVA|ANCOVA with MI||Treatment comparison was made using the multiple imputation (MI) strategy by combining the results of analysis of covariance (ANCOVA) model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening hemoglobin (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.591|0.365|<0.0001
71876006|NCT02273726|143270521|NON_INFERIORITY|The non-inferiority was established when the 2-sided 95% CI for the difference of LS means between the 2 treatment groups using the MMRM model lay entirely above -0.75 g/dL.|LS Mean Difference|0.55|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|0.404|0.687|||Mixed Models Analysis|||Treatment comparison was made using a mixed model of repeated measures (MMRM) with baseline Hb as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.687|0.404|<0.0001
71876007|NCT02273726|143270522|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|7.6|||||TWO_SIDED|95.0|0.9|14.3||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||14.3|0.9|
71876008|NCT02273726|143270523|NON_INFERIORITY|Non-inferiority was established if the lower bound of the 2-sided 95% CI for the treatment difference for the responder rates (roxadustat minus epoetin alfa) calculated based on the Miettinen \& Nurminen approach, adjusting for stratification factors, was greater than -15%.|Responder Rate Difference|2.7|||||TWO_SIDED|95.0|-4.3|9.7||||||For the difference of responder rates between 2 treatment groups, the CI analyzed was from the Miettinen \& Nurminen approach adjusting for randomization stratification factors.||9.7|-4.3|
71916716|NCT04474366|143355216|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||||||0.72
71916717|NCT02550093|143355217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||HEAT||||.47
71916718|NCT02550093|143355217|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.70
71916719|NCT02550093|143355218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.84
71916720|NCT02550093|143355218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.95
71916721|NCT02550093|143355219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||HEAT||||0.92
71684116|NCT04015518|142886312|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0771||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0771
71684117|NCT04015518|142886313|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|-0.005|0.427|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.427|-0.005|
71684118|NCT04015518|142886313|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.17|||||TWO_SIDED|95.0|-0.032|0.401|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.401|-0.032|
71684119|NCT04015518|142886313|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.248|||||TWO_SIDED|95.0|0.032|0.471|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.471|0.032|
71684120|NCT04015518|142886313|OTHER|Logistic regression with fixed classification effects included treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.|Risk Difference (RD)|0.202|||||TWO_SIDED|95.0|0.024|0.367|||||Confidence intervals were calculated using the cumulative distribution function method of Reeve. Difference was calculated as Speso - placebo.|||0.367|0.024|
71684121|NCT04015518|142886313|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0158||||||Adjusted for multiplicity.|MCP-Mod linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0158
71684122|NCT04015518|142886313|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.012||||||Adjusted for multiplicity.|MCP-Mod Emax model fit|"Assumed 70% of the maximum effect was achieved at the low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0120
71684123|NCT04015518|142886313|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0429||||||Adjusted for multiplicity.|MCP-Mod Exponential model fit|"Assumed 25% of the maximum effect was achieved at the medium-low dose regimen."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0429
71758571|NCT04922216|143019379|SUPERIORITY||Mean Difference (Net)|0.39||||0.7|TWO_SIDED|95.0|-0.52|1.3|||Mixed Models Analysis|Degrees of freedom (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 6 months).||1.30|-0.52|0.70
71916722|NCT02550093|143355219|SUPERIORITY_OR_OTHER_LEGACY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||COLD||||0.63
71916723|NCT02550093|143355220|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71916724|NCT02550093|143355221|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71916725|NCT02550093|143355222|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||||||0.62
71916726|NCT02550093|143355223|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71916727|NCT02550093|143355224|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||||||0.97
71916728|NCT02550093|143355225|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||||||0.61
71916729|NCT02550093|143355226|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
71916730|NCT02550093|143355227|SUPERIORITY_OR_OTHER_LEGACY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71916731|NCT02550093|143355228|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71916732|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation between test and reference drugs are 98% and 17.24%, respectively|Geometric mean ratio|95.204|||||TWO_SIDED|90.0|87.618|103.446|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.446|87.618|
71916733|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and coefficient of variation are 80% and 22.62%, respectively.|Geometric mean ratio|107.606|||||TWO_SIDED|90.0|96.552|119.924|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.924|96.552|
71916734|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 16.26%, respectively.|Geometric mean ratio|104.373|||||TWO_SIDED|90.0|96.504|112.883|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B= FDC (test value)|||112.883|96.504|
71916735|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 81% and 14.42%,respectively.|Geometric mean ratio|88.188|||||TWO_SIDED|90.0|82.368|94.419|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||94.419|82.368|
71916736|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 13.09%, respectively.|Geometric mean ratio|98.168|||||TWO_SIDED|90.0|92.263|104.451|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.451|92.263|
71916737|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|5-OH saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 8.02%, respectively.|Geometric mean ratio|95.023|||||TWO_SIDED|90.0|91.47|98.714|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.714|91.470|
71916738|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 15.55%, respectively.|Geometric mean ratio|97.601|||||TWO_SIDED|90.0|15.55|99.0|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99|15.55|
71916739|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 84% and 15.65%, respectively.|Geometric mean ratio|110.656|||||TWO_SIDED|90.0|102.416|119.559|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||119.559|102.416|
71916740|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|OH-Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.61%, respectively.|Geometric mean ratio|106.264|||||TWO_SIDED|90.0|99.826|113.117|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||113.117|99.826|
71916741|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.30%, respectively.|Geometric mean ratio|100.028|||||TWO_SIDED|90.0|95.164|105.139|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||105.139|95.164|
71916742|NCT01365091|143355229|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.38%, respectively.|Geometric mean ratio|93.644|||||TWO_SIDED|95.0|89.055|98.47|||ANCOVA|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.470|89.055|
71916743|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1: The corresponding power and coefficient of variation are 98% and 17.24%, respectively.|Geometric mean ratio|91.508|||||TWO_SIDED|90.0|82.596|101.38|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.380|82.596|
71916744|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.66%, respectively.|Geometric mean ratio|97.437|||||TWO_SIDED|90.0|93.889|101.119|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.119|93.889|
71916745|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.43%, respectively.|Geometric mean ratio|96.77|||||TWO_SIDED|90.0|93.35|100.316|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.316|93.350|
71916746|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.37%, respectively.|Geometric mean ratio|91.585|||||TWO_SIDED|90.0|85.56|98.035|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||98.035|85.56|
71916747|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 96.028% and 101.095%, respectively.|Geometric mean ratio|98.529|||||TWO_SIDED|90.0|96.028|101.095|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.095|96.028|
71916748|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.55%, respectively|Geometric mean ratio|96.239|||||TWO_SIDED|90.0|93.286|99.286|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.286|93.286|
71758572|NCT04922216|143019379|SUPERIORITY||Mean Difference (Net)|-0.55||||0.47|TWO_SIDED|95.0|-1.45|0.36|||Mixed Models Analysis|Degrees of freedom (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 6 months).||0.36|-1.45|0.47
71916749|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.19%, respectively.|Geometric mean ratio|102.994|||||TWO_SIDED|90.0|96.956|109.407|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||109.407|96.956|
71916750|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.135|||||TWO_SIDED|95.0|93.778|100.613|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.613|93.778|
71916751|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.18%, respectively.|Geometric mean ratio|100.01|||||TWO_SIDED|90.0|96.512|103.648|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.648|96.512|
71916752|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 1:The corresponding power and the variation coefficient are 93% and 17.35%, respectively.|Geometric mean ratio|92.953|||||TWO_SIDED|90.0|85.502|101.053|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.053|85.502|
71916753|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.75%, respectively.|Geometric mean ratio|101.281|||||TWO_SIDED|95.0|98.494|104.147|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.147|98.494|
71916754|NCT01365091|143355230|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.73%, respectively.|Geometric mean ratio|100.111|||||TWO_SIDED|90.0|97.367|102.932|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.932|97.367|
71916755|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|For AUC(0-inf) metformin, Arm 1, the corresponding power and coefficient of variation are 80% and 21.06%, respectively.|Geometric mean ratio|91.494|||||TWO_SIDED|90.0|82.697|101.226|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||101.226|82.697|
71916756|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.60%, respectively.|Geometric mean ratio|97.477|||||TWO_SIDED|90.0|93.955|101.132|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.132|93.955|
71916757|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 1. The corresponding power and the coefficient of variation are 99% and 07.31%, respectively.|Geometric mean ratio|96.76|||||TWO_SIDED|90.0|93.393|100.247|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).|||100.247|93.393|
71916758|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.25%, respectively.|Geometric mean ratio|91.548|||||TWO_SIDED|90.0|85.573|97.939|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||97.939|85.573|
71916759|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 5.38%,respectively.|Geometric mean ratio|98.535|||||TWO_SIDED|95.0|96.044|101.09|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||101.090|96.044|
71916760|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.52%, respectively.|Geometric mean ratio|96.258|||||TWO_SIDED|95.0|93.319|99.29|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||99.290|93.319|
71916761|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 11.75%, respectively.|Geometric mean ratio|102.383|||||TWO_SIDED|95.0|96.589|108.525|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||108.525|96.589|
71916762|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 5: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.187|||||TWO_SIDED|90.0|93.832|100.662|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||100.662|93.832|
71916763|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Sarexagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.08%, respectively.|Geometric mean ratio|100.015|||||TWO_SIDED|95.0|96.56|103.594|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||103.594|96.560|
71916764|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Metformin, Arm 4: The corresponding power and the variation coefficient are 94% and 17.13%, respectively.|Geometric mean ratio|93.219|||||TWO_SIDED|90.0|85.835|101.238|||ANCOVA|||||101.238|85.835|
71916765|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.72%, respectively.|Geometric mean ratio|101.346|||||TWO_SIDED|90.0|98.574|104.196|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||104.196|98.574|
71916766|NCT01365091|143355232|NON_INFERIORITY_OR_EQUIVALENCE|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.71%, respectively.|Geometric mean ratio|100.056|||||TWO_SIDED|90.0|97.324|102.864|||ANCOVA||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)|||102.864|97.324|
71916767|NCT03649815|143355247|OTHER|||||||0.067|||||||Paired Sample T-Test|||||||0.067
71916768|NCT03649815|143355247|OTHER|||||||0.071||||||Controlled for gender, age, and baseline symptomatology|Paired Sample T-Test|||||||0.071
71916769|NCT03649815|143355248|OTHER|||||||0.047|||||||Paired Sample T-Test|||||||0.047
71916770|NCT03649815|143355248|OTHER|||||||0.036||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.036
71916771|NCT03649815|143355249|OTHER|||||||0.032|||||||Paired Sample T-Test|||||||0.032
71916772|NCT03649815|143355249|OTHER|||||||0.006||||||Controlled for gender, age and baseline symptomatology|Paired Sample T-Test|||||||0.006
71916773|NCT02859558|143355266|SUPERIORITY|||||||0.48||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.48
71916774|NCT02859558|143355266|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71916775|NCT02859558|143355266|SUPERIORITY|||||||0.5||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.50
71916776|NCT02859558|143355266|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
71916777|NCT02859558|143355266|SUPERIORITY|||||||0.44||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.44
71916778|NCT02859558|143355266|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71916779|NCT02859558|143355267|SUPERIORITY|||||||0.39||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.39
71916780|NCT02859558|143355267|SUPERIORITY|||||||0.46||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.46
71916781|NCT02859558|143355267|SUPERIORITY|||||||0.056||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.056
71916782|NCT02859558|143355267|SUPERIORITY|||||||0.025||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.025
71916783|NCT02859558|143355267|SUPERIORITY|||||||0.072||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.072
71916784|NCT02859558|143355267|SUPERIORITY|||||||0.47||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.47
71916785|NCT02859558|143355267|SUPERIORITY|||||||0.086||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.086
71916786|NCT02859558|143355267|SUPERIORITY|||||||0.18||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.18
71916787|NCT02859558|143355267|SUPERIORITY|||||||0.88||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.88
71916788|NCT02859558|143355267|SUPERIORITY|||||||0.061||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.061
71916789|NCT02859558|143355267|SUPERIORITY|||||||0.042||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.042
71916790|NCT02859558|143355267|SUPERIORITY|||||||0.54||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.54
71916791|NCT02859558|143355268|SUPERIORITY|||||||0.97||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.97
71876009|NCT02273726|143270524|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|Least Square Mean Difference|-14.67|STANDARD_ERROR_OF_MEAN|1.514|<|0.0001|TWO_SIDED|95.0|-17.64|-11.695|||Mixed Models Analysis|||Treatment comparison was made using a MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-11.695|-17.640|<0.0001
71876010|NCT02273726|143270525|NON_INFERIORITY|The non-inferiority margin was fixed as a difference of -0.75.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.093|<|0.0001|TWO_SIDED|95.0|0.503|0.869||Threshold for significance at 0.05 level.|ANCOVA|ANCOVA with MI||Treatment comparison was made using the MI strategy by combining the results of ANCOVA model with baseline Hb as a covariate, and treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and other randomization stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.869|0.503|<0.0001
71876011|NCT02273726|143270526|SUPERIORITY||LS Mean Difference|-20.14|STANDARD_ERROR_OF_MEAN|6.975||0.00091|TWO_SIDED|95.0|-33.842|-6.445||Threshold for significance at 0.05 level.|Rank ANCOVA|||Treatment comparison was made using an ANCOVA model with baseline iron repletion status, treatment, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||-6.445|-33.842|0.00091
71876012|NCT02273726|143270527|NON_INFERIORITY|The non-inferiority margin for the difference between groups was 1.8.|Hazard Ratio (HR)|0.67||||0.0337|TWO_SIDED|95.0|0.466|0.97|||Cox Proportional Hazards model|||Analysis was done using a Cox Proportional Hazards model adjusting for baseline Hb and other stratification factors except mean qualifying screening Hb (≤10.5 vs. \>10.5 g/dL) as fixed effects.||0.970|0.466|0.0337
71876013|NCT02273726|143270528|SUPERIORITY|Superiority was declared if the upper bound of the 2-sided 95% CI of the difference between roxadustat and epoetin alfa (roxadustat - epoetin alpha) was less than 0.|LS Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.739||0.35|TWO_SIDED|95.0|-0.76|2.142|||Mixed Models Analysis|||Treatment comparison was made using MMRM with baseline as a covariate, and treatment, visit, visit-by-treatment interaction, ESA dependent incident dialysis within ≤4 months vs. \>4 months of starting dialysis when randomized, and randomization stratification factors as fixed effects.||2.142|-0.760|0.3500
71876014|NCT02877927|143270546|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|5.0|||||TWO_SIDED|95.0|-0.2|10.3|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||10.3|-0.2|
71876015|NCT02877927|143270547|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|3.3|||||TWO_SIDED|95.0|-2.2|8.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||8.9|-2.2|
71876016|NCT02877927|143270548|NON_INFERIORITY|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.3|||||TWO_SIDED|95.0|-0.6|5.6|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.|||5.6|-0.6|
71876017|NCT03672461|143270565|SUPERIORITY||Model based LS mean difference|0.29||||0.056|TWO_SIDED|95.0|-0.01|0.6|||Mixed Models Analysis|adjusted for baseline value. Repeated measures mixed models, unstructured variance co-variance matrix||Null Hypothesis: Yoga is not associated with improvement in change from baseline in Total Urinary Incontinence Episodes||0.6|-0.01|0.056
71876018|NCT03672461|143270566|SUPERIORITY||Model based LS mean difference|0.03||||0.757|TWO_SIDED|95.0|-0.15|0.2|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.2|-0.15|0.757
71876019|NCT03672461|143270567|SUPERIORITY||Model based LS mean difference|0.22||||0.048|TWO_SIDED|95.0|0.0|0.45|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.45|0|0.048
71876020|NCT03672461|143270568|SUPERIORITY||Model based LS mean difference|0.82||||0.911|TWO_SIDED|95.0|-13.6|15.23|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||15.23|-13.6|0.911
71876021|NCT03672461|143270569|SUPERIORITY||Model based LS mean difference|3.13||||0.041|TWO_SIDED|95.0|0.13|6.13|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.13|0.13|0.041
71876022|NCT03672461|143270570|SUPERIORITY||Model based LS mean difference|0.07||||0.564|TWO_SIDED|95.0|-0.16|0.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.3|-0.16|0.564
71876023|NCT03672461|143270571|SUPERIORITY||Model based LS mean difference|0.3||||0.764|TWO_SIDED|95.0|-1.69|2.3|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.3|-1.69|0.764
71876024|NCT03672461|143270572|SUPERIORITY||Model based LS mean difference|-0.12||||0.883|TWO_SIDED|95.0|-1.78|1.53|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.53|-1.78|0.883
71876025|NCT03672461|143270573|SUPERIORITY||Model based LS mean difference|-0.11||||0.753|TWO_SIDED|95.0|-0.83|0.6|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.6|-0.83|0.753
71876026|NCT03672461|143270574|SUPERIORITY||Model based LS mean difference|-0.28||||0.685|TWO_SIDED|95.0|-1.63|1.07|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.07|-1.63|0.685
71876027|NCT03672461|143270575|SUPERIORITY||Model based LS mean difference|0.24||||0.691|TWO_SIDED|95.0|-0.95|1.43|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.43|-0.95|0.691
71876028|NCT03672461|143270576|SUPERIORITY||Model based LS mean difference|0.19||||0.743|TWO_SIDED|95.0|-0.95|1.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.34|-0.95|0.743
71876029|NCT03672461|143270577|SUPERIORITY||Model based LS mean difference|0.98||||0.043|TWO_SIDED|95.0|0.03|1.93|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||1.93|0.03|0.043
71876030|NCT03672461|143270578|SUPERIORITY||Model based LS mean difference|0.99||||0.689|TWO_SIDED|95.0|-3.87|5.84|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||5.84|-3.87|0.689
71876031|NCT03672461|143270579|SUPERIORITY||Model based LS mean difference|-3.4||||0.276|TWO_SIDED|95.0|-9.54|2.74|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.74|-9.54|0.276
71876032|NCT03672461|143270580|SUPERIORITY||Model based LS mean difference|0.1||||0.448|TWO_SIDED|95.0|-0.15|0.34|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.34|-0.15|0.448
71876033|NCT03672461|143270581|SUPERIORITY||Model based LS mean difference|-0.29||||0.319|TWO_SIDED|95.0|-0.86|0.28|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.28|-0.86|0.319
71876034|NCT03672461|143270582|SUPERIORITY||Model based LS mean difference|1.21||||0.747|TWO_SIDED|95.0|-6.25|8.67|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||8.67|-6.25|0.747
71684124|NCT04015518|142886313|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.0229||||||Adjusted for multiplicity.|MCP-Mod Logistic model fit|"Assumed 20% of maximum effect was achieved at the low dose, 95% of maximum effect was achieved at medium high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0229
71684125|NCT04015518|142886313|OTHER|Logistic regression estimates were used as input for the MCP-Mod, with fixed classification effects including treatment and region (Japan vs. Non-Japan). In case 0 event are observed a penalized regression based on the Firth's bias reduction method was used. The estimates from the logistic regression are on the logit scale, the difference in proportions were calculated as the difference between the predicted probabilities in the treatment groups on the original scale.||||||0.03||||||Adjusted for multiplicity.|MCP-Mod Sigmoid Emax model fit|"Assumed 10% of the maximum effect was achieved at low dose, 80% of the maximum effect was achieved at the medium-high dose."||A flat vs. non-flat dose-response relationship across the 4 doses of Spesolimab and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, Emax, exponential, logistic, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.05).||||0.0300
71876035|NCT03672461|143270583|SUPERIORITY||Model based LS mean difference|-2.76||||0.459|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.459
71876036|NCT03672461|143270584|SUPERIORITY||Model based LS mean difference|-2.0||||0.556|TWO_SIDED|95.0|-10.2|4.65|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||4.65|-10.2|0.556
71876037|NCT03672461|143270585|SUPERIORITY||Model based LS mean difference|-3.26||||0.516|TWO_SIDED|95.0|-13.2|6.7|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||6.7|-13.2|0.516
71876038|NCT03672461|143270586|SUPERIORITY||Model based LS mean difference|-2.38||||0.154|TWO_SIDED|95.0|-5.68|0.91|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||0.91|-5.68|0.154
71876039|NCT03672461|143270587|SUPERIORITY||Model based LS mean difference|-2.22||||0.375|TWO_SIDED|95.0|-7.17|2.72|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.72|-7.17|0.375
71876040|NCT03672461|143270588|SUPERIORITY||Model based LS mean difference|-1.75||||0.287|TWO_SIDED|95.0|-5.0|1.5|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||1.5|-5|0.287
71876041|NCT03672461|143270589|SUPERIORITY||Model based LS mean difference|-1.63||||0.147|TWO_SIDED|95.0|-3.85|0.58||adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix|Mixed Models Analysis|||||0.58|-3.85|0.147
71876042|NCT03672461|143270590|SUPERIORITY||Model based LS mean difference|-1.37||||0.495|TWO_SIDED|95.0|-5.36|2.61|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, with unstructured variance co-variance matrix||||2.61|-5.36|0.495
71916792|NCT02859558|143355268|SUPERIORITY|||||||0.21||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.21
71916793|NCT02859558|143355268|SUPERIORITY|||||||0.12||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.||||0.12
71916794|NCT02859558|143355268|SUPERIORITY|||||||0.055||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.055
71916795|NCT02859558|143355268|SUPERIORITY|||||||0.28||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.28
71916796|NCT02859558|143355268|SUPERIORITY|||||||0.38||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.||||0.38
71684126|NCT04015518|142886314|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-18.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-37.2|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-37.2|
71684127|NCT04015518|142886314|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-19.3|STANDARD_ERROR_OF_MEAN|9.6|||TWO_SIDED|95.0|-38.3|-0.2|||||Difference was calculated as Speso - placebo.|||-0.2|-38.3|
71684128|NCT04015518|142886314|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-26.6|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-45.5|-7.8|||||Difference was calculated as Speso - placebo.|||-7.8|-45.5|
71684129|NCT04015518|142886314|OTHER|MMRM included 'baseline' as a continuous covariate, and 'visit', 'treatment', 'region' (stratification according to Japan vs. non-Japan), 'visit\*treatment' and 'visit\*baseline' interaction as fixed effects as well as the random 'subject' effect. Covariance structure= Unstructured.|Difference of adjusted means|-5.4|STANDARD_ERROR_OF_MEAN|7.9|||TWO_SIDED|95.0|-21.1|10.2|||||Difference was calculated as Speso - placebo.|||10.2|-21.1|
71684130|NCT02195427|142886315|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Global Action and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.03|||||TWO_SIDED|97.5|-0.17|0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."||0.11|-0.17|
71684131|NCT02195427|142886315|NON_INFERIORITY|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Deep Lines and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|97.5|-0.25|0.06|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline"||0.06|-0.25|
71684132|NCT03053427|142886329|SUPERIORITY||LSM difference|-1.2|STANDARD_ERROR_OF_MEAN|0.7||0.088|TWO_SIDED|95.0|-2.6|0.2|||Mixed Model of Repeated Measurements|||MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.||0.2|-2.6|0.088
71684133|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.051|TWO_SIDED|95.0|-2.2|0.0|||ANCOVA|Time frame: week 1||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.0|-2.2|0.051
71876043|NCT03672461|143270591|SUPERIORITY||Model based LS mean difference|-2.82||||0.303|TWO_SIDED|95.0|-8.22|2.59|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||2.59|-8.22|0.303
71684134|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.02|TWO_SIDED|95.0|-2.8|-0.2|||ANCOVA|Time frame: week 2||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.8|0.020
71684135|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.028|TWO_SIDED|95.0|-2.9|-0.2|||ANCOVA|Time frame: week 4||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-2.9|0.028
71876044|NCT03672461|143270592|SUPERIORITY||Model based LS mean difference|2.97||||0.196|TWO_SIDED|95.0|-1.56|7.51|||Mixed Models Analysis|adjusted for baseline value Repeated measures mixed models, unstructured variance co-variance matrix||||7.51|-1.56|0.196
71876045|NCT01444651|143270607|SUPERIORITY_OR_OTHER||beta estimate|-1.25|STANDARD_ERROR_OF_MEAN|1.29||0.34|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.||||0.34
71876046|NCT01444651|143270608|SUPERIORITY_OR_OTHER||beta estimate|0.96|STANDARD_ERROR_OF_MEAN|0.68||0.18|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.18
71876047|NCT01444651|143270609|SUPERIORITY_OR_OTHER||beta estimate|-0.18|STANDARD_ERROR_OF_MEAN|0.58||0.76|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.||||0.76
71876048|NCT01444651|143270610|SUPERIORITY_OR_OTHER||beta estimate|1.48|STANDARD_ERROR_OF_MEAN|0.77||0.06|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.06
71876049|NCT01444651|143270611|SUPERIORITY_OR_OTHER||beta estimate|3.76|STANDARD_ERROR_OF_MEAN|1.38||0.009|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.||||0.009
71876050|NCT01444651|143270612|SUPERIORITY_OR_OTHER||beta estimate|8.09|STANDARD_ERROR_OF_MEAN|4.05||0.05|TWO_SIDED||||||Regression, Linear|||Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.||||0.05
71876051|NCT00726622|143270615|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71876052|NCT02462928|143270628|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-3.8|||||TWO_SIDED|95.1|-8.2|0.3|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.3|-8.2|
71876053|NCT02462928|143270628|NON_INFERIORITY|For hypothesis testing, if the lower limit of 95.1% Confidence Interval (CI) for the difference between an abicipar group and ranibizumab was greater than or equal to -10%, non-inferiority of abicipar was established.|Percentage Difference|-4.2|||||TWO_SIDED|95.1|-8.7|0.0|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as stratification factor.|||0.0|-8.7|
71876054|NCT02462928|143270629|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|Least Squares (LS) Mean Difference|-2.4|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-4.7|-0.1|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-0.1|-4.7|
71876055|NCT02462928|143270629|NON_INFERIORITY|For hypothesis testing, non-inferiority of abicipar is established if the lower limit of the CI is \> - 5.0 letters.|LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.1|-6.0|-1.3|||||MMRM included treatment, region, BL BCVA, BL CRT ≤400 or \>400, choroidal neovascularization lesion type, visit, visit-by-BL BCVA interaction, and treatment-by-visit interaction term as covariates using an unstructured covariance matrix.|||-1.3|-6.0|
71876056|NCT02462928|143270630|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|8.6|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-3.8|20.9|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||20.9|-3.8|
71876057|NCT02462928|143270630|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|6.3|||TWO_SIDED|95.1|-10.1|14.7|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, CRT, choroidal neovascularization lesion type, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||14.7|-10.1|
71876058|NCT02462928|143270631|SUPERIORITY||Percentage Difference|-4.7|||||TWO_SIDED|95.1|-11.5|2.1|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||2.1|-11.5|
71876059|NCT02462928|143270631|SUPERIORITY||Percentage Difference|-8.2|||||TWO_SIDED|95.1|-14.7|-1.5|||||The 95.1% CI for the weighted difference were calculated based on the Newcombe method using the Cochran-Mantel-Haenszel weights and baseline BCVA (≤55 vs \>55 letters) as the stratification factor.|||-1.5|-14.7|
71876060|NCT02462928|143270632|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-3.7|0.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||-0.0|-3.7|
71876061|NCT02462928|143270632|SUPERIORITY|Superiority of abicipar was demonstrated if the lower limit of CI for the treatment difference was greater than zero.|LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.1|-2.7|1.0|||||MMRM was used for analyses with covariates (treatment, region, baseline BCVA, visual function questionnaire (VFQ) score, visit, visit by baseline BCVA and treatment by visit interaction) with unstructured covariance matrix.|||1.0|-2.7|
71876062|NCT01493557|143270633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.31||||0.2554|TWO_SIDED|95.0|-6.54|29.49|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||29.49|-6.54|0.2554
71876063|NCT01493557|143270634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1||||0.3165|TWO_SIDED|95.0|-11.24|24.58|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||24.58|-11.24|0.3165
71876064|NCT01493557|143270635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.41||||0.0273|TWO_SIDED|95.0|0.71|35.98|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||35.98|0.71|0.0273
71876065|NCT01493557|143270636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52||||0.7104|TWO_SIDED|95.0|-44.22|28.4|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.40|-44.22|0.7104
71876066|NCT01493557|143270637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.81||||1|TWO_SIDED|95.0|-32.94|40.44|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||40.44|-32.94|1.0000
71876067|NCT01493557|143270638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.71||||1|TWO_SIDED|95.0|-41.25|28.77|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.||28.77|-41.25|1.0000
71876068|NCT01493557|143270642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-9.9|8.9|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for the Duration of gastrointestinal symptoms (GIS).||8.9|-9.9|
71876069|NCT01493557|143270642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-3.5|6.3|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||6.3|-3.5|
71876070|NCT01493557|143270642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.2|||||TWO_SIDED|95.0|-8.2|48.5|||||Mean difference = (Mean number of days for Pradaxa w/meal) - (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.||48.5|-8.2|
71876071|NCT02656420|143270647|EQUIVALENCE|Statistical significance of the treatment effect (p \< 0.01) for the lower doses compared to the high dose as the reference.|Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.89|-1.57||Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).|Mixed Models Analysis|||The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.||-1.57|-1.89|<0.001
71876072|NCT02656420|143270648|SUPERIORITY|To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.|Mean Difference (Final Values)|63.2|||<|0.05|TWO_SIDED|95.0|10.6|140.9|||Regression, Linear||This Estimation Parameter was based on the comparison between the full dose group and the placebo group.|All broccoli sprout arms were compared with the placebo arm.||140.9|10.6|<0.05
71876073|NCT03829241|143270845|SUPERIORITY||LS Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.7||0.917|TWO_SIDED|95.0|-1.45|1.3|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||1.30|-1.45|0.917
71876074|NCT00698451|143270851|SUPERIORITY_OR_OTHER||Percentage|72.2||||0.05|TWO_SIDED|95.0|58.4|83.5|||Exact Binomial Distribution|||||83.5|58.4|0.05
71876075|NCT01187550|143270856|SUPERIORITY_OR_OTHER|||||||0.194||95.0|||||Wilcoxon rank sum test|||||||0.194
71876076|NCT01187550|143270857|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Wilcoxon rank sum test|||||||0.752
71876077|NCT01187550|143270858|SUPERIORITY_OR_OTHER|||||||0.71||95.0|||||Wilcoxon rank sum test|||||||0.710
71876078|NCT01187550|143270859|SUPERIORITY_OR_OTHER|||||||0.265||95.0|||||Wilcoxon rank sum test|||||||0.265
71876079|NCT01187550|143270860|SUPERIORITY_OR_OTHER|||||||0.308||95.0|||||Wilcoxon rank sum test|||||||0.308
71876080|NCT01187550|143270861|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||Wilcoxon rank sum test|||For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.078
71876081|NCT01187550|143270861|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Wilcoxon rank sum test|||For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.033
71876082|NCT01187550|143270861|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Wilcoxon rank sum test|||For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.||||0.041
71876083|NCT01187550|143270861|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||Wilcoxon rank sum test|||For triglycerides: Wilcoxon rank sum test was used to calculate p-value.||||0.091
71876084|NCT00733304|143270883|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|1.362|||TWO_SIDED|95.0|-3.18|2.31||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||2.31|-3.18|
71876085|NCT00733304|143270883|SUPERIORITY||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.659|||TWO_SIDED|95.0|-7.13|-0.46||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||-0.46|-7.13|
71876086|NCT00733304|143270883|SUPERIORITY||Mean Difference (Net)|-4.15|STANDARD_ERROR_OF_MEAN|1.672|||TWO_SIDED|95.0|-7.52|-0.78||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 2 versus screening visit||-0.78|-7.52|
71876087|NCT00733304|143270883|SUPERIORITY||Mean Difference (Net)|-4.03|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|95.0|-7.53|0.53||Analysis of covariance (ANCOVA) model was used to perform statistical analysis based on treatment, visit, fixed effect terms etc.|ANCOVA|||Month 5 versus screening visit||0.53|-7.53|
71876088|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|8.28|STANDARD_ERROR_OF_MEAN|16.899|||TWO_SIDED|95.0|-25.72|42.29||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||For Month 1 versus Screening visit||42.29|-25.72|
71876089|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|-1.21|STANDARD_ERROR_OF_MEAN|17.177|||TWO_SIDED|95.0|-35.73|33.31||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||33.31|-35.73|
71876090|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|-5.11|STANDARD_ERROR_OF_MEAN|17.958|||TWO_SIDED|95.0|-41.08|30.86||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||30.86|-41.08|
71876091|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|-9.92|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-47.83|28.0||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||28.00|-47.83|
71876092|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|2.42|STANDARD_ERROR_OF_MEAN|18.996|||TWO_SIDED|95.0|-35.5|40.33||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||40.33|-35.50|
71876093|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|9.05|STANDARD_ERROR_OF_MEAN|20.931|||TWO_SIDED|95.0|-33.09|51.2||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 1 versus Screening visit||51.20|-33.09|
71876094|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|-1.24|STANDARD_ERROR_OF_MEAN|21.29|||TWO_SIDED|95.0|-44.05|41.57||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 2 versus Screening visit||41.57|-44.05|
71876095|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|15.39|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-28.28|59.06||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 3 versus Screening visit||59.06|-28.28|
71876096|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|-16.82|STANDARD_ERROR_OF_MEAN|22.183|||TWO_SIDED|95.0|-61.28|27.63||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 4 versus Screening visit||27.63|-61.28|
71684136|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.043|TWO_SIDED|95.0|-2.9|0.0|||ANCOVA|Time frame: week 6||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.0|-2.9|0.043
71876097|NCT00733304|143270884|SUPERIORITY||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|21.757|||TWO_SIDED|95.0|-45.83|41.51||ANCOVA model was used to perform statistical analysis based on treatment, visit, fixed effect terms, Baseline OCT central subfield as covariate, and participant within treatment as a random effect term.|ANCOVA|||Month 5 versus Screening visit||41.51|-45.83|
71876098|NCT02616614|143270895|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80,1.25\] for the PP population.|Mean Difference (Net)|0.95|||||TWO_SIDED|90.0|0.88|1.03||||||||1.03|0.88|
71876099|NCT02616614|143270895|SUPERIORITY|||||||0.0001|||||||ANOVA|||||||0.0001
71876100|NCT02616614|143270895|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71876101|NCT02616614|143270896|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval \[0.80, 1.25\] for the PP population.|Mean Difference (Net)|1.0|||||TWO_SIDED|90.0|0.9|1.11||||||||1.11|0.90|
71876102|NCT02616614|143270896|SUPERIORITY|||||||0.0002|||||||ANOVA|||||||0.0002
71876103|NCT02616614|143270896|SUPERIORITY|||||||0.0006|||||||ANOVA|||||||0.0006
71876104|NCT02616614|143270897|EQUIVALENCE|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Mean Difference (Net)|-0.022|||||TWO_SIDED|90.0|-0.087|0.043|||||Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).||0.043|-0.087|
71876105|NCT00596934|143270898|SUPERIORITY_OR_OTHER|||||||0.015|||||||t-test, 2 sided|||Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P\<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study||||0.015
71876106|NCT00596934|143270899|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71876107|NCT00596934|143270900|SUPERIORITY_OR_OTHER|||||||0.074||||||p = 0.074|t-test, 2 sided|||||||0.074
71876108|NCT00596934|143270901|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71876109|NCT00596934|143270902|SUPERIORITY_OR_OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71876110|NCT00596934|143270903|SUPERIORITY_OR_OTHER|||||||0.023|||||||t-test, 2 sided|||||||0.023
71876111|NCT00596934|143270904|SUPERIORITY_OR_OTHER|||||||0.195||||||p-value = 0.195.|t-test, 2 sided|||||||0.195
71876112|NCT00596934|143270905|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
71876113|NCT03239483|143270907|SUPERIORITY|||||||0.072|||||||Fisher Exact|||two-sided Fisher's Exact Test||||0.072
71876114|NCT03239483|143270912|SUPERIORITY|||||||1||||||This is a calculated p-value. P-values of 1.0 are possible when using the Fisher Exact test method.|Fisher Exact|||||||1.00
71876115|NCT03239483|143270913|SUPERIORITY|||||||0.591|||||||Fisher Exact|||||||0.591
71876116|NCT04464265|143270914|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|2.0|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = BOLD Response During Sedation - BOLD Response During Baseline|The null hypothesis is no difference in BOLD response between sedated state and baseline. For an fMRI study of cognitive function, Desmond and Glover (J. Neurosci. Methods., 2002) reported that about 25 subjects are necessary to achieve 80% power for a 0.5% increase of activity. We analyzed 27 subjects that fulfilled the suggested optimal group size for reliable statistics in functional MRI studies (also see Thirion et al., Neuroimage, 2007).||||<0.001
71876117|NCT04464265|143270915|OTHER|Our study adopted a within-subject design, which is not a randomized controlled trial (RCT). The P-value below indicates if propofol administration has a statistically significant impact on the brain activity in response to sensory stimuli.|Mean Difference (Net)|-2.72|STANDARD_DEVIATION|3.17|<|0.001|TWO_SIDED|||||The threshold for statistical significance was p=0.05. The p-value was not adjusted for multiple comparisons, as only one comparison was performed.|t-test, 2 sided||Difference = Squeeze Pressure During Sedation - Squeeze Pressure During Baseline|||||<0.001
71876118|NCT01063829|143270916|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
71876119|NCT01063829|143270916|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
71876120|NCT01063829|143270916|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
71876121|NCT01063829|143270917|SUPERIORITY_OR_OTHER|||||||0.002|||||||Log Rank|||||||0.002
71876122|NCT01063829|143270917|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||||||0.126
71876123|NCT01063829|143270917|SUPERIORITY_OR_OTHER|||||||0.148|||||||Log Rank|||||||0.148
71876124|NCT01063829|143270918|SUPERIORITY_OR_OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
71876125|NCT01063829|143270918|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
71876126|NCT01063829|143270918|SUPERIORITY_OR_OTHER|||||||0.321|||||||Fisher Exact|||||||0.321
71876127|NCT01829360|143270941|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|The significance of fixed effects (e.g.,treatment) was evaluated using Wald tests||||||<0.05
71876128|NCT01829360|143270941|OTHER|A secondary analysis was performed to examine individual differences in treatment outcomes. This was done collapsed across all arms because the difference between the arms/treatments was not significant in the primary analysis. This was done by adding predictors to the primary analysis model to determine if learner characteristics were significantly related to growth in word defining. All continuous learner characteristics were grand mean centered.|||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71876129|NCT01829360|143270942|SUPERIORITY||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||The interim definition data were analyzed with the primary pre-/post-definition data to capture growth across the entire treatment period.||||<0.05
71876130|NCT00778622|143270965|SUPERIORITY_OR_OTHER|||||||0.0806||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.||"Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method CI for mean for one group in nQuery Advisor v6.0."||||0.0806
71876131|NCT00778622|143270965|SUPERIORITY_OR_OTHER|||||||0.1984||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.1984
71876132|NCT00778622|143270965|SUPERIORITY_OR_OTHER|||||||0.0232||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.0232
71916797|NCT02859558|143355268|SUPERIORITY|||||||0.35||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.35
71684137|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.184|TWO_SIDED|95.0|-2.4|0.5|||ANCOVA|Time frame: week 8||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.5|-2.4|0.184
71684138|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.027|TWO_SIDED|95.0|-3.1|-0.2|||ANCOVA|Time frame: week 10||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||-0.2|-3.1|0.027
71876133|NCT00778622|143270965|SUPERIORITY_OR_OTHER|||||||0.3589||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.3589
71916798|NCT02859558|143355268|SUPERIORITY|||||||0.007||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.007
71916799|NCT02859558|143355268|SUPERIORITY|||||||0.045||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.||||0.045
71916800|NCT02859558|143355268|SUPERIORITY|||||||0.085||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.085
71876134|NCT00778622|143270966|SUPERIORITY_OR_OTHER|||||||0.4614||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.||||||0.4614
71876135|NCT00778622|143270966|SUPERIORITY_OR_OTHER|||||||0.4696||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.4696
71876136|NCT00778622|143270966|SUPERIORITY_OR_OTHER|||||||0.5305||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.5305
71876137|NCT00778622|143270966|SUPERIORITY_OR_OTHER|||||||0.9145||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided|||||||0.9145
71876138|NCT00778622|143270967|SUPERIORITY_OR_OTHER|||||||0.0305||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.||||||0.0305
71876139|NCT00778622|143270967|SUPERIORITY_OR_OTHER|||||||0.008||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0080
71876140|NCT00778622|143270967|SUPERIORITY_OR_OTHER|||||||0.0422||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0422
71916801|NCT02859558|143355268|SUPERIORITY|||||||0.044||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.044
71916802|NCT02859558|143355268|SUPERIORITY|||||||0.6||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.||||0.60
71684139|NCT03053427|142886330|SUPERIORITY||LSM difference|-1.4|STANDARD_ERROR_OF_MEAN|0.8||0.087|TWO_SIDED|95.0|-3.0|0.2|||ANCOVA|Time frame: week 12||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.2|-3.0|0.087
71684140|NCT03053427|142886330|SUPERIORITY||LSM difference|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.312|TWO_SIDED|95.0|-2.4|0.8|||ANCOVA|Time frame: EoT||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.||0.8|-2.4|0.312
71876141|NCT00778622|143270968|SUPERIORITY_OR_OTHER|||||||0.4508||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.||||||0.4508
71876142|NCT00778622|143270968|SUPERIORITY_OR_OTHER|||||||0.0526||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.0526
71876143|NCT00778622|143270968|SUPERIORITY_OR_OTHER|||||||0.1295||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.1295
71876144|NCT00778622|143270969|SUPERIORITY_OR_OTHER|||||||0.1431||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.||||||0.1431
71876145|NCT00778622|143270969|SUPERIORITY_OR_OTHER|||||||0.4066||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4066
71916803|NCT02859558|143355269|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
71876146|NCT00778622|143270969|SUPERIORITY_OR_OTHER|||||||0.4071||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.4071
71876147|NCT00778622|143270970|SUPERIORITY_OR_OTHER|||||||0.021||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.||||||0.0210
71876148|NCT00778622|143270970|SUPERIORITY_OR_OTHER|||||||0.2507||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.2507
71876149|NCT00778622|143270970|SUPERIORITY_OR_OTHER|||||||0.6546||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided|||||||0.6546
71876150|NCT03427125|143271060|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71876151|NCT03427125|143271061|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.0020
71876152|NCT05315947|143271091|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for Cmax was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.87|||||TWO_SIDED|90.0|0.7814|0.9686||||||||0.9686|0.7814|
71876153|NCT05315947|143271092|EQUIVALENCE|Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(0-t) was within the 0.80 to 1.25 range.|Ratio of Dry Syrup/ Tablet|0.989|||||TWO_SIDED|90.0|0.9756|1.003||||||||1.003|0.9756|
71876154|NCT03610165|143271097|SUPERIORITY||Median Difference (Final Values)|0.0||||0.757|TWO_SIDED|95.0|-0.03|0.04|||Wilcoxon (Mann-Whitney)|||||0.04|-0.03|0.757
71876155|NCT03610165|143271098|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.715|TWO_SIDED|95.0|-12.0|7.0|||Wilcoxon (Mann-Whitney)|||||7|-12|0.715
71876156|NCT03610165|143271099|SUPERIORITY||Median Difference (Final Values)|-1.0||||0.328|TWO_SIDED|95.0|-3.3|1.0|||Wilcoxon (Mann-Whitney)|||||1|-3.3|0.328
71876157|NCT03610165|143271100|SUPERIORITY||Median Difference (Final Values)|0.0||||0.376|TWO_SIDED|95.0|-0.001|0.011|||Wilcoxon (Mann-Whitney)|||||0.011|-0.001|0.376
71876158|NCT03610165|143271101|SUPERIORITY||Median Difference (Final Values)|0.0||||0.226|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.226
71876159|NCT03610165|143271102|SUPERIORITY||Median Difference (Final Values)|0.0||||0.61|TWO_SIDED|95.0|-0.67|2.0|||Wilcoxon (Mann-Whitney)|||||2.00|-0.67|0.610
71876160|NCT03610165|143271103|SUPERIORITY||Median Difference (Final Values)|0.0||||0.302|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.302
71876161|NCT03610165|143271104|SUPERIORITY||Median Difference (Final Values)|0.0||||0.889|TWO_SIDED|95.0|-0.67|0.67|||Wilcoxon (Mann-Whitney)|||||0.67|-0.67|0.889
71876162|NCT03610165|143271105|SUPERIORITY||Median Difference (Final Values)|0.0||||0.403|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.403
71876163|NCT00708175|143271108|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.17|TWO_SIDED|95.0|-1.33|0.24||P-value is from a 1-way ANCOVA with treatment group as a factor and baseline BMD as a covariate. There were no multiplicity adjustments.|ANCOVA|||The sample size was calculated using a precision approach to estimate the difference between the pioglitazone and placebo treatment groups in the percent change from baseline in BMD.||0.24|-1.33|0.170
71916804|NCT02859558|143355269|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71876164|NCT00708175|143271109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.64|TWO_SIDED|95.0|-0.91|0.56||P-value is from a 1-way ANCOVA with treatment group as a factor and the Month 12 BMD value as a covariate. There were no multiplicity adjustments.|ANCOVA|||||0.56|-0.91|0.640
71876165|NCT01703663|143271119|SUPERIORITY_OR_OTHER||absolute difference|-5.73||||0.183|TWO_SIDED|95.0|-14.4|2.97|||ANOVA|||||2.97|-14.4|0.183
71876166|NCT00315939|143271227|SUPERIORITY_OR_OTHER||||||=|0.001|||||||ANOVA|||||||=0.001
71876167|NCT04667247|143271230|OTHER||ratio of frequencies|0.94||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
71876168|NCT04667247|143271233|OTHER||ratio of frequencies|1.022||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
71876169|NCT04667247|143271235|OTHER||ratio of frequencies|4.828||||0.061|TWO_SIDED||||||Chi-squared, Corrected|||||||0.061
71876170|NCT04667247|143271236|OTHER||ratio of frequencies|3.526||||0.1|TWO_SIDED||||||Chi-squared, Corrected|||||||.100
71876171|NCT04667247|143271237|OTHER||ratio of frequencies|0.005||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.000
71876172|NCT04667247|143271238|OTHER||ratio of frequencies|3.036||||0.162|TWO_SIDED||||||Chi-squared, Corrected|||||||.162
71876173|NCT04667247|143271240|OTHER||ratio of frequencies|0.151||||1|TWO_SIDED||||||Chi-squared, Corrected|||||||1.00
71876174|NCT04667247|143271241|SUPERIORITY||F value|1.908||||0.174|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.174
71876175|NCT04667247|143271242|SUPERIORITY||F value|0.038||||0.846|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.846
71876176|NCT04667247|143271243|SUPERIORITY||F value|0.041||||0.841|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.841
71876177|NCT04667247|143271244|SUPERIORITY||F value|0.261||||0.612|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.612
71876178|NCT04667247|143271245|SUPERIORITY||F value|0.161||||0.69|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.690
71876179|NCT04667247|143271246|SUPERIORITY||F value|2.671||||0.109|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.109
71876180|NCT04667247|143271247|SUPERIORITY||F value|0.039||||0.844|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.844
71876181|NCT04667247|143271248|SUPERIORITY||F value|4.28||||0.044|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.044
71876182|NCT04667247|143271249|SUPERIORITY||F value|0.001||||0.989|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||.989
71876183|NCT04667247|143271250|SUPERIORITY||F value|7.186||||0.01|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.010
71876184|NCT04667247|143271251|SUPERIORITY||F value|0.345||||0.56|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||.560
71876185|NCT04667247|143271252|SUPERIORITY||F value|0.143||||0.707|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.707
71876186|NCT04667247|143271253|SUPERIORITY||F value|0.09||||0.765|TWO_SIDED||||||Mixed Models Analysis||Day by Group interaction|||||0.765
71876187|NCT04667247|143271254|SUPERIORITY||F value|7.835||||0.005|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||0.005
71876188|NCT04667247|143271255|SUPERIORITY||F value|16.56|||<|0.001|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||<0.001
71876189|NCT01436071|143271271|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.12||||0.012|TWO_SIDED|95.0|0.026|0.213|||ANCOVA|||||0.213|0.026|0.012
71876190|NCT00789867|143271277|OTHER|||||||0.0002|||||||Kruskal-Wallis|||||||0.0002
71876191|NCT00789867|143271278|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
71876192|NCT00789867|143271279|OTHER|||||||0.06|||||||Kruskal-Wallis|||||||0.06
71876193|NCT00789867|143271280|OTHER|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71876194|NCT00789867|143271281|OTHER|||||||0.22|||||||Kruskal-Wallis|||||||0.22
71916805|NCT02859558|143355269|SUPERIORITY|||||||0.64||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||0.64
71916806|NCT02859558|143355269|SUPERIORITY|||||||0.69||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.69
71876195|NCT00789867|143271282|OTHER|||||||0.003|||||||Kruskal-Wallis|||||||0.003
71876196|NCT03662139|143271285|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
71876197|NCT03662139|143271285|SUPERIORITY||ICC|0.97|||<|0.05|TWO_SIDED|95.0|0.915|0.99|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)||0.99|0.915|<0.05
71876198|NCT03662139|143271285|SUPERIORITY||ICC|0.983|||<|0.01|TWO_SIDED|95.0|0.882|0.998|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: \>0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; \<0.50=low|Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)||0.998|0.882|<0.01
71876199|NCT03662139|143271286|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
71876200|NCT03662139|143271286|SUPERIORITY||Spearman's correlation coefficient (rs)|0.724|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test|The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.||Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy group||||<0.05
71876201|NCT03662139|143271287|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
71876202|NCT03662139|143271287|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.828|||<|0.01|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy group||||<0.01
71916807|NCT02859558|143355269|SUPERIORITY|||||||0.4||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||0.40
71876203|NCT03662139|143271288|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference||||<0.01
71876204|NCT03662139|143271288|SUPERIORITY||Spearman's correlation coefficient (rs)|-0.673|||<|0.05|TWO_SIDED||||||Spearman's Correlation Test||The level of relationship was classified as follows \<0.30=small/negligible; 0.30-0.50=low; 0.50-0.70=moderate; 0.70-0.90=high; \>0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.||||<0.05
71876205|NCT01215175|143271289|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
71876206|NCT01215175|143271290|OTHER||Risk Difference (RD)|8.2||||||95.0|-7.9|26.6|||||Miettinen \& Nurminen method|||26.6|-7.9|
71876207|NCT01215175|143271290|OTHER||Risk Difference (RD)|3.6||||||95.0|-15.5|22.9|||||Miettinen \& Nurminen method|||22.9|-15.5|
71876208|NCT01215175|143271291|OTHER||Risk Difference (RD)|0.0||||||95.0|-11.5|11.5|||||Miettinen \& Nurminen method|||11.5|-11.5|
71876209|NCT01215175|143271292|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.2|10.6|||||Miettinen \& Nurminen method|||10.6|-12.2|
71876210|NCT01215175|143271292|OTHER||Risk Difference (RD)|0.0||||||95.0|-12.3|12.3|||||Miettinen \& Nurminen method|||12.3|-12.3|
71876211|NCT01215175|143271293|OTHER||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen \& Nurminen method|||28.3|-7.4|
71876212|NCT01215175|143271294|OTHER||Risk Difference (RD)|9.8||||||95.0|-10.6|30.9|||||Miettinen \& Nurminen method|||30.9|-10.6|
71876213|NCT01215175|143271294|OTHER||Risk Difference (RD)|3.6||||||95.0|-19.1|26.0|||||Miettinen \& Nurminen method|||26.0|-19.1|
71876214|NCT00702845|143271310|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.|Mean Difference (Final Values)|2.5|||<|0.001|TWO_SIDED|95.0|1.2|3.9|||ANOVA|||||3.9|1.2|<0.001
71876215|NCT02973425|143271327|OTHER||Cox Proportional Hazard|1.68||||0.02|TWO_SIDED|95.0|1.09|2.6|||Regression, Cox|||The primary hypothesis was tested through a time-to-event analysis implemented using Cox proportional hazards models||2.60|1.09|0.02
71876216|NCT02973425|143271328|OTHER||Linear regression|0.03||||0.03|TWO_SIDED|95.0|||||Regression, Linear|||For hypothesis 3, we compared the mean score on the SEQ-12 and its subscales at 6 months, adjusting for baseline.||||0.03
71876217|NCT02973425|143271329|OTHER|Six-month OR, 95%CI, and P value were calculated from generalized estimating equation marginal models with a logit link and an exchangeable correlation matrix.|Odds Ratio (OR)|1.92||||0.048|TWO_SIDED|95.0|1.01|3.68||Analysis models were adjusted by study site, having quit attempts in the past 12 months measured at baseline, cigarettes per day measured at baseline, quit attempts in the past 12 months measured at baseline.|Chi-squared|||||3.68|1.01|0.048
71684141|NCT03053427|142886331|SUPERIORITY||difference|4.2||||0.467|TWO_SIDED|95.0|-6.4|14.8|||Fisher Exact|||||14.8|-6.4|0.467
71684142|NCT03053427|142886332|SUPERIORITY||difference|5.8||||0.3|TWO_SIDED|95.0|-4.8|16.5|||Fisher Exact|||||16.5|-4.8|0.300
71684143|NCT03053427|142886333|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.877|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.5|-0.5|0.877
71684144|NCT03053427|142886334|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.975|TWO_SIDED|95.0|-0.7|0.7|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.7|-0.7|0.975
71684145|NCT03053427|142886335|SUPERIORITY||LSM difference|0.0|STANDARD_ERROR_OF_MEAN|0.2||0.838|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.||0.3|-0.4|0.838
71684146|NCT03816644|142886341|SUPERIORITY||Odds Ratio (OR)|3.43|||||TWO_SIDED|95.0|2.32|5.07||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in dementia care outcomes between the intervention and control groups at 90 days post screening visit. Models are adjusted for age, sex, and years of education.||5.07|2.32|
71684147|NCT03816644|142886342|SUPERIORITY||Odds Ratio (OR)|1.133|||||TWO_SIDED|95.0|0.837|1.534||||||The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in participants who were hospitalized or visited an ER 6 months post screening visit.||1.534|0.837|
71684148|NCT02172040|142886346|NON_INFERIORITY|Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm.|||||=|0.001|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine.||||= 0.001
71684149|NCT02172040|142886346|SUPERIORITY||||||=|0.491|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The secondary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with placebo was superior to treatment with celecoxib. This was only to be performed if statistical significance was achieved for the primary comparison.||||= 0.491
71684150|NCT02172040|142886347|OTHER||||||=|0.166|||||||Chi-squared|||||||= 0.166
71876218|NCT02973425|143271330|OTHER||Odds Ratio (OR)|2.01||||0.01|TWO_SIDED|95.0|||||Regression, Linear|||During the first 3 weeks from randomization, both the Take a Break and comparison groups reported the number of cigarettes smoked daily (by texting); texting response rate (responded on at least 1 day).||||0.01
71684151|NCT02172040|142886348|SUPERIORITY|||||||0.177|||||||t-test, 1 sided|||||||0.177
71684152|NCT02172040|142886348|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684153|NCT02172040|142886348|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71876219|NCT03503513|143271348|SUPERIORITY||Risk Ratio (RR)|0.17|||<|0.0001|TWO_SIDED|95.0|0.03|0.2|||differences in incidence rate ratio|An incidence rate ratio per person/month was determined by comparing the total number of UTIs in relation to time points.||comparison between pre and during treatment rates of UTI||0.20|0.03|<0.0001
71876220|NCT03503513|143271349|SUPERIORITY||Mean Difference (Final Values)|-3.8|STANDARD_DEVIATION|6.13|<|0.06|TWO_SIDED|95.0|-7.9|0.3||a priori threshold p value of \<0.05|t-test, 2 sided||Baseline to end of 6 month treatment score comparisons; (higher numbers represent more symptoms or complications)|NBSS Domain score for incontinence pre-post comparison; small sample size did not allow for power calculation.||0.3|-7.9|<0.06
71684154|NCT02172040|142886348|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684155|NCT02172040|142886348|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684156|NCT02172040|142886348|SUPERIORITY||||||=|0.719|||||||t-test, 1 sided|||||||= 0.719
71684157|NCT02172040|142886349|SUPERIORITY||||||=|0.069|||||||t-test, 1 sided|||||||= 0.069
71684158|NCT02172040|142886349|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
71684159|NCT02172040|142886349|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684160|NCT02172040|142886349|SUPERIORITY||||||=|0.097|||||||t-test, 1 sided|||||||= 0.097
71684161|NCT02172040|142886349|SUPERIORITY||||||=|0.064|||||||t-test, 1 sided|||||||= 0.064
71684162|NCT02172040|142886349|SUPERIORITY||||||=|0.924|||||||t-test, 1 sided|||||||= 0.924
71684163|NCT02172040|142886350|SUPERIORITY||||||=|0.038|||||||t-test, 1 sided|||||||= 0.038
71684164|NCT02172040|142886350|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684165|NCT02172040|142886350|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684166|NCT02172040|142886350|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684167|NCT02172040|142886350|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684168|NCT02172040|142886350|SUPERIORITY||||||=|0.562|||||||t-test, 1 sided|||||||= 0.562
71684169|NCT02172040|142886351|SUPERIORITY||||||=|0.104|||||||t-test, 1 sided|||||||= 0.104
71684170|NCT02172040|142886351|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684171|NCT02172040|142886351|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684172|NCT02172040|142886351|SUPERIORITY||||||=|0.002|||||||t-test, 1 sided|||||||= 0.002
71684173|NCT02172040|142886351|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684174|NCT02172040|142886351|SUPERIORITY||||||=|0.419|||||||t-test, 1 sided|||||||= 0.419
71684175|NCT02172040|142886352|SUPERIORITY||||||=|0.028|||||||t-test, 1 sided|||||||= 0.028
71684176|NCT02172040|142886352|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684177|NCT02172040|142886352|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71876221|NCT03503513|143271349|SUPERIORITY||Mean Difference (Final Values)|-1.1|STANDARD_DEVIATION|4.09|<|0.39|TWO_SIDED|95.0|-3.8|1.7||a priori threshold p\<0.05|t-test, 2 sided||(higher numbers represent more symptoms or complications)|NBSS Domain score for storage and voiding; pre-post comparison. Due to small sample size (n=11) no power calculations were conducted.||1.7|-3.8|<0.39
71684178|NCT02172040|142886352|SUPERIORITY||||||=|0.051|||||||t-test, 1 sided|||||||= 0.051
71684179|NCT02172040|142886352|SUPERIORITY||||||=|0.074|||||||t-test, 1 sided|||||||= 0.074
71876222|NCT03503513|143271349|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|3.99|<|0.14|TWO_SIDED|95.0|-4.6|0.8|||t-test, 2 sided||Higher numbers represent more symptoms or complications referred as consequences.|Pre and post test comparisons of mean NBSS scores for the consequences domain. Power calculations were not conducted due to small sample size.||0.8|-4.6|<0.14
71876223|NCT03503513|143271350|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_DEVIATION|6.99|<|0.34|TWO_SIDED|95.0|-6.8|2.6|||t-test, 2 sided|||||2.6|-6.8|<0.34
71876224|NCT03627767|143271370|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.0001|TWO_SIDED|95.0|0.286|0.424||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.424|0.286|< 0.0001
71876225|NCT03627767|143271370|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.0001|TWO_SIDED|95.0|0.176|0.27||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.270|0.176|< 0.0001
71876226|NCT03627767|143271370|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.503|0.78||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.780|0.503|< 0.0001
71876227|NCT03627767|143271371|SUPERIORITY||Difference in percentage|0.0|||=|0.9495|TWO_SIDED|95.0|-1.0|1.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.1|-1.0|= 0.9495
71876228|NCT03627767|143271371|SUPERIORITY||Difference in percentage|-0.4|||=|0.5717|TWO_SIDED|95.0|-1.6|0.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.6|= 0.5717
71876229|NCT03627767|143271371|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.7|0.9||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.9|-1.7|
71876230|NCT03627767|143271371|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.1|47.8||P-value was adjusted by disease severity at baseline and randomization strata|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.8|33.1|< 0.0001
71876231|NCT03627767|143271371|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.1|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.1|< 0.0001
71876232|NCT03627767|143271371|SUPERIORITY||Difference in percentage|22.1|||||TWO_SIDED|95.0|14.3|29.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.9|14.3|
71876233|NCT03627767|143271371|SUPERIORITY||Difference in percentage|35.1|||<|0.0001|TWO_SIDED|95.0|28.1|42.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.0|28.1|< 0.0001
71916808|NCT02859558|143355269|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.||||1
71916809|NCT02859558|143355269|SUPERIORITY|||||||1||||||No adjustments for multiple comparisons. P-value based on two-sided test.|Fisher Exact|||Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.||||1
71684180|NCT02172040|142886352|SUPERIORITY||||||=|0.878|||||||t-test, 1 sided|||||||= 0.878
71684181|NCT02172040|142886353|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684182|NCT02172040|142886354|OTHER||||||=|0.977|||||||t-test, 1 sided|||||||= 0.977
71684183|NCT02172040|142886355|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684184|NCT02172040|142886356|OTHER||||||=|0.527|||||||t-test, 1 sided|||||||= 0.527
71684185|NCT02172040|142886357|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684186|NCT02172040|142886357|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684187|NCT02172040|142886357|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71684188|NCT02172040|142886357|SUPERIORITY||||||=|0.001|||||||t-test, 1 sided|||||||= 0.001
71684189|NCT01801241|142886361|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71684190|NCT03240406|142886362|SUPERIORITY||Mean Difference (Net)|-0.06||||0.259|TWO_SIDED|95.0|-0.15|0.04||Test of the between arm difference in the global composite at Burst 2, adjusted for the study arm, baseline (Burst 1) global composite, and the randomization stratification factors (baseline sex, age, and years of education)|ANCOVA|ANCOVA of Burst 2 composite adjusted for arm, Burst 1 composite, sex, age, and education. Missing/invalid data were multiply imputed using MICE|Mean Difference of MHD Arm compared to control|||0.04|-0.15|0.259
71684191|NCT03240406|142886363|SUPERIORITY||Mean Difference (Net)|-0.64||||0.001|TWO_SIDED|95.0|-1.02|-0.27||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.27|-1.02|0.001
71684192|NCT03240406|142886364|SUPERIORITY||Mean Difference (Net)|-0.94|||<|0.001|TWO_SIDED|95.0|-1.34|-0.54||Estimated from ANCOVA model adjusted for baseline value, age, sex, and years of education at baseline.|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education.|Mean Difference of MHD Arm vs Comparison Arm|||-0.54|-1.34|<0.001
71684193|NCT03240406|142886365|SUPERIORITY||Mean Difference (Net)|0.24||||0.904|TWO_SIDED|95.0|-3.63|4.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.11|-3.63|0.904
71684194|NCT03240406|142886366|SUPERIORITY||Mean Difference (Net)|-0.12||||0.721|TWO_SIDED|95.0|-0.76|0.52||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; tocopherol biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.52|-0.76|0.721
71684195|NCT03240406|142886367|SUPERIORITY||Mean Difference (Net)|0.0||||0.769|TWO_SIDED|95.0|-0.01|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, and education; carotenoid biomarker values additionally adjusted for Burst 1 and Burst 2 levels of HDL, LDL, and triglycerides|ANCOVA|Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education; Burst 1 and Burst 2 levels of HDL, LDL and triglycerides|Mean Difference of MHD Arm vs Comparison Arm|||0.01|-0.01|0.769
71684196|NCT03240406|142886368|SUPERIORITY||Mean Difference (Net)|-1.37||||0.978|TWO_SIDED|95.0|-100.13|97.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||97.4|-100.13|0.978
71876234|NCT03627767|143271371|SUPERIORITY||Difference in percentage|51.5|||<|0.0001|TWO_SIDED|95.0|44.6|58.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.4|44.6|< 0.0001
71876235|NCT03627767|143271371|SUPERIORITY||Difference in percentage|16.5|||||TWO_SIDED|95.0|8.1|24.8||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.8|8.1|
71684197|NCT03240406|142886369|SUPERIORITY||Mean Difference (Net)|0.15||||0.395|TWO_SIDED|95.0|-0.2|0.51||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Monounsaturated Fat||0.51|-0.2|0.395
71684198|NCT03240406|142886369|SUPERIORITY||Mean Difference (Net)|-0.11||||0.019|TWO_SIDED|95.0|-0.21|-0.02||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for Long Chain Saturated Fat||-0.02|-0.21|0.019
71684199|NCT03240406|142886369|SUPERIORITY||Mean Difference (Net)|0.12||||0.201|TWO_SIDED|95.0|-0.07|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for EPA||0.31|-0.07|0.201
71684200|NCT03240406|142886369|SUPERIORITY||Mean Difference (Net)|0.27||||0.039|TWO_SIDED|95.0|0.01|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|Statistical Analysis results for DHA||0.53|0.01|0.039
71684201|NCT03240406|142886369|SUPERIORITY||Mean Difference (Net)|-0.01||||0.619|TWO_SIDED|95.0|-0.06|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean difference of MHD Arm vs Comparison Arm|Statistical Analysis results for n3 DPA||0.03|-0.06|0.619
71876236|NCT03627767|143271371|SUPERIORITY||Difference in percentage|32.2|||<|0.0001|TWO_SIDED|95.0|25.2|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.2|< 0.0001
71876237|NCT03627767|143271371|SUPERIORITY||Difference in percentage|46.9|||<|0.0001|TWO_SIDED|95.0|39.9|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.9|< 0.0001
71876238|NCT03627767|143271371|SUPERIORITY||Difference in percentage|14.2|||||TWO_SIDED|95.0|5.9|22.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.6|5.9|
71684202|NCT03240406|142886370|SUPERIORITY||Mean Difference (Net)|0.18||||0.521|TWO_SIDED|95.0|-0.37|0.73||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.73|-0.37|0.521
71684203|NCT03240406|142886371|SUPERIORITY||Mean Difference (Net)|145.0||||0.101|TWO_SIDED|95.0|-27.7|317.6||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||317.6|-27.7|0.101
71684204|NCT03240406|142886372|SUPERIORITY||Mean Difference (Net)|-24.63||||0.645|TWO_SIDED|95.0|-129.16|79.89||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||79.89|-129.16|0.645
71876239|NCT03627767|143271371|SUPERIORITY||Difference in percentage|25.5|||<|0.0001|TWO_SIDED|95.0|18.5|32.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.5|18.5|< 0.0001
71684205|NCT03240406|142886373|SUPERIORITY||Mean Difference (Net)|3.26||||0.245|TWO_SIDED|95.0|-2.23|8.75||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||8.75|-2.23|0.245
71684206|NCT03240406|142886374|SUPERIORITY||Mean Difference (Net)|0.21||||0.032|TWO_SIDED|95.0|0.02|0.4||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.4|0.02|0.032
71684207|NCT03240406|142886375|SUPERIORITY||Mean Difference (Net)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.26|0.08|<0.001
71876240|NCT03627767|143271371|SUPERIORITY||Difference in percentage|42.5|||<|0.0001|TWO_SIDED|95.0|35.3|49.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.7|35.3|< 0.0001
71684208|NCT03240406|142886376|SUPERIORITY||Mean Difference (Net)|-1.36||||0.635|TWO_SIDED|95.0|-6.95|4.24||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||4.24|-6.95|0.635
71876241|NCT03627767|143271371|SUPERIORITY||Difference in percentage|17.1|||||TWO_SIDED|95.0|8.6|25.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.6|
71876242|NCT03627767|143271372|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
71876243|NCT03627767|143271372|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions. P-value was adjusted by disease severity at baseline and randomization strata.||0.0|0.0|
71876244|NCT03627767|143271372|SUPERIORITY||Difference in percentage|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.0|0.0|
71876245|NCT03627767|143271372|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.3|50.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.1|35.3|< 0.0001
71876246|NCT03627767|143271372|SUPERIORITY||Difference in percentage|55.4|||<|0.0001|TWO_SIDED|95.0|49.1|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|49.1|< 0.0001
71876247|NCT03627767|143271372|SUPERIORITY||Difference in percentage|12.9|||||TWO_SIDED|95.0|7.9|17.9||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.9|7.9|
71684209|NCT03240406|142886377|SUPERIORITY||Mean Difference (Net)|-3.52||||0.019|TWO_SIDED|95.0|-6.44|0.59||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.59|-6.44|0.019
71684210|NCT03240406|142886378|SUPERIORITY||Mean Difference (Net)|-3.13||||0.639|TWO_SIDED|95.0|-16.18|9.92||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||9.92|-16.18|0.639
71684211|NCT03240406|142886379|SUPERIORITY||Mean Difference (Net)|41.71|||<|0.001|TWO_SIDED|95.0|21.47|61.96||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||61.96|21.47|<0.001
71684212|NCT03240406|142886380|SUPERIORITY||Mean Difference (Net)|-15.37||||0.115|TWO_SIDED|95.0|-34.44|3.69||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||3.69|-34.44|0.115
71684213|NCT03240406|142886381|SUPERIORITY||Mean Difference (Net)|0.06||||0.847|TWO_SIDED|95.0|-0.53|0.64||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.64|-0.53|0.847
71684214|NCT03240406|142886382|SUPERIORITY||Mean Difference (Net)|118.57||||0.191|TWO_SIDED|95.0|-58.62|295.76||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||295.76|-58.62|0.191
71684215|NCT03240406|142886383|SUPERIORITY||Mean Difference (Net)|955.19||||0.019|TWO_SIDED|95.0|164.63|1745.74||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1745.74|164.63|0.019
71684216|NCT03240406|142886384|SUPERIORITY||Mean Difference (Net)|-15.74||||0.493|TWO_SIDED|95.0|-60.66|29.19||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||29.19|-60.66|0.493
71916810|NCT05665595|143355270|OTHER||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.87|1.8|||||Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma risk-based stage (IIB/IIC/clinical IIB and IIC/IIIA/IIIB vs IIIC/IIID/IV) and region of enrollment (Asia vs ROW).|||1.80|0.87|
71916811|NCT00142818|143355278|SUPERIORITY|||||||0.4|||||||ANOVA|||||||0.4
71684217|NCT03240406|142886385|SUPERIORITY||Mean Difference (Net)|14.83||||0.18|TWO_SIDED|95.0|-6.78|36.45||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||36.45|-6.78|0.18
71684218|NCT03240406|142886386|SUPERIORITY||Mean Difference (Net)|436.14||||0.379|TWO_SIDED|95.0|-534.05|1406.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1406.33|-534.05|0.379
71684219|NCT03240406|142886387|SUPERIORITY||Mean Difference (Net)|784.06||||0.083|TWO_SIDED|95.0|-99.73|1667.85||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||1667.85|-99.73|0.083
71684220|NCT03240406|142886388|SUPERIORITY||Mean Difference (Net)|1.33||||0.011|TWO_SIDED|95.0|0.32|2.35||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||2.35|0.32|0.011
71684221|NCT03240406|142886389|SUPERIORITY||Mean Difference (Net)|0.07||||0.541|TWO_SIDED|95.0|-0.16|0.31||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.31|-0.16|0.541
71916812|NCT02903966|143355295|OTHER||Least Square Mean Difference|-0.18|||||TWO_SIDED|95.0|-1.23|0.87|||||Analysis performed using a Mixed Models Repeated Measures (MMRM) model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||0.87|-1.23|
71916813|NCT02903966|143355296|OTHER||Least Square Mean Difference|0.02|||||TWO_SIDED|95.0|-1.18|1.22|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and baseline value by visit interactions|||1.22|-1.18|
71916814|NCT02903966|143355297|OTHER||Least Square Mean Difference|-0.05|||||TWO_SIDED|95.0|-4.11|4.02|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.02|-4.11|
71916815|NCT02903966|143355297|OTHER||Least Square Mean Difference|-3.17|||||TWO_SIDED|95.0|-5.99|-0.35|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||-0.35|-5.99|
71876248|NCT03627767|143271372|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|37.9|53.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.0|37.9|< 0.0001
71876249|NCT03627767|143271372|SUPERIORITY||Difference in percentage|63.0|||<|0.0001|TWO_SIDED|95.0|56.4|69.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.5|56.4|< 0.0001
71876250|NCT03627767|143271372|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|10.7|24.7||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||24.7|10.7|
71876251|NCT03627767|143271372|SUPERIORITY||Difference in percentage|41.0|||<|0.0001|TWO_SIDED|95.0|33.6|48.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.5|33.6|< 0.0001
71876252|NCT03627767|143271372|SUPERIORITY||Difference in percentage|58.3|||<|0.0001|TWO_SIDED|95.0|51.3|65.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||65.2|51.3|< 0.0001
71876253|NCT03627767|143271372|SUPERIORITY||Difference in percentage|17.5|||||TWO_SIDED|95.0|9.6|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.6|
71876254|NCT03627767|143271372|SUPERIORITY||Difference in percentage|35.3|||<|0.0001|TWO_SIDED|95.0|27.8|42.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||42.8|27.8|< 0.0001
71876255|NCT03627767|143271372|OTHER||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.3|62.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.4|48.3|< 0.0001
71876256|NCT03627767|143271372|SUPERIORITY||Difference in percentage|20.3|||||TWO_SIDED|95.0|12.1|28.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||28.5|12.1|
71876257|NCT03627767|143271373|SUPERIORITY||Difference in percentage|0.7|||=|0.1848|TWO_SIDED|95.0|-0.3|1.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.7|-0.3|= 0.1848
71876258|NCT03627767|143271373|SUPERIORITY||Difference in percentage|0.3|||=|0.5971|TWO_SIDED|95.0|-0.9|1.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.6|-0.9|= 0.5971
71876259|NCT03627767|143271373|SUPERIORITY||Difference in percentage|-0.4|||||TWO_SIDED|95.0|-1.1|0.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||0.4|-1.1|
71876260|NCT03627767|143271373|SUPERIORITY||Difference in percentage|49.4|||<|0.0001|TWO_SIDED|95.0|42.0|56.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||56.8|42.0|< 0.0001
71876261|NCT03627767|143271373|SUPERIORITY||Difference in percentage|65.5|||<|0.0001|TWO_SIDED|95.0|59.3|71.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||71.7|59.3|< 0.0001
71876262|NCT03627767|143271373|SUPERIORITY||Difference in percentage|16.3|||||TWO_SIDED|95.0|10.3|22.3||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|10.3|
71916816|NCT02903966|143355297|OTHER||Least Square Mean Difference|-1.69|||||TWO_SIDED|95.0|-6.26|2.88|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||2.88|-6.26|
71916817|NCT02903966|143355298|OTHER||Least Square Mean Difference|0.29|||||TWO_SIDED|95.0|-4.01|4.59|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||4.59|-4.01|
71876263|NCT03627767|143271373|SUPERIORITY||Difference in percentage|42.7|||<|0.0001|TWO_SIDED|95.0|35.2|50.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.2|35.2|< 0.0001
71876264|NCT03627767|143271373|SUPERIORITY||Difference in percentage|62.6|||<|0.0001|TWO_SIDED|95.0|56.0|69.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.2|56.0|< 0.0001
71876265|NCT03627767|143271373|SUPERIORITY||Difference in percentage|19.8|||||TWO_SIDED|95.0|12.3|27.4||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.4|12.3|
71916818|NCT02903966|143355298|OTHER||Least Square Mean Difference|0.11|||||TWO_SIDED|95.0|-3.64|3.85|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||3.85|-3.64|
71916819|NCT02903966|143355298|OTHER||Least Square Mean Difference|1.12|||||TWO_SIDED|95.0|-2.87|5.1|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline value, and the treatment by visit and Baseline value by visit interactions|||5.10|-2.87|
71916820|NCT02903966|143355299|OTHER||Ratio|0.7|||||TWO_SIDED|95.0|0.27|1.8|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.80|0.27|
71916821|NCT02903966|143355299|OTHER||Ratio|0.44|||||TWO_SIDED|95.0|0.2|1.0|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.00|0.20|
71916822|NCT02903966|143355299|OTHER||Ratio|0.23|||||TWO_SIDED|95.0|0.09|0.62|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.62|0.09|
71916823|NCT02903966|143355300|OTHER||Ratio|0.49|||||TWO_SIDED|95.0|0.25|0.97|||||Day 57. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||0.97|0.25|
71916824|NCT02903966|143355300|OTHER||Ratio|0.56|||||TWO_SIDED|95.0|0.2|1.57|||||Day 71. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||1.57|0.20|
71916825|NCT02903966|143355300|OTHER||Ratio|0.82|||||TWO_SIDED|95.0|0.31|2.18|||||Day 85. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, log-transformed Baseline value, and the treatment by visit and log-transformed baseline value by visit interactions.|||2.18|0.31|
71916826|NCT02903966|143355301|OTHER||Least Square Mean Difference|0.01|||||TWO_SIDED|95.0|-2.05|2.07|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.07|-2.05|
71916827|NCT02903966|143355302|OTHER||Least Square Mean Difference|0.08|||||TWO_SIDED|95.0|-2.11|2.27|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||2.27|-2.11|
71916828|NCT02903966|143355303|OTHER||Least Square Mean Difference|-0.76|||||TWO_SIDED|95.0|-5.29|3.77|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||3.77|-5.29|
71916829|NCT02903966|143355304|OTHER||Least Square Mean Difference|-0.8|||||TWO_SIDED|95.0|-5.68|4.08|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||4.08|-5.68|
71916830|NCT02903966|143355309|OTHER||Least Square Mean Difference|-0.36|||||TWO_SIDED|95.0|-1.58|0.86|||||Day 15. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||0.86|-1.58|
71916831|NCT02903966|143355309|OTHER||Least Square Mean Difference|-0.1|||||TWO_SIDED|95.0|-1.29|1.08|||||Day 29. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.08|-1.29|
71916832|NCT02903966|143355309|OTHER||Least Square Mean Difference|-0.34|||||TWO_SIDED|95.0|-1.72|1.04|||||Day 43. Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.04|-1.72|
71916833|NCT02903966|143355310|OTHER||Least Square Mean Difference|-0.06|||||TWO_SIDED|95.0|-1.87|1.75|||||Analysis performed using a MMRM model, adjusting for the following covariates: treatment, visit, Baseline score, and the treatment by visit and Baseline score by visit interactions.|||1.75|-1.87|
71916834|NCT04423718|143355314|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.97||||0.0009|TWO_SIDED|95.0|-2.87|0.92||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.92|-2.87|0.0009
71876266|NCT03627767|143271373|SUPERIORITY||Difference in percentage|39.5|||<|0.0001|TWO_SIDED|95.0|32.1|46.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.9|32.1|< 0.0001
71876267|NCT03627767|143271373|SUPERIORITY||Difference in percentage|56.7|||<|0.0001|TWO_SIDED|95.0|49.8|63.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||63.7|49.8|< 0.0001
71876268|NCT03627767|143271373|SUPERIORITY||Difference in percentage|17.4|||||TWO_SIDED|95.0|9.3|25.5||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|9.3|
71876269|NCT03627767|143271373|SUPERIORITY||Difference in percentage|33.0|||<|0.0001|TWO_SIDED|95.0|25.7|40.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||40.4|25.7|< 0.0001
71876270|NCT03627767|143271373|SUPERIORITY||Difference in percentage|51.7|||<|0.0001|TWO_SIDED|95.0|44.6|58.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.8|44.6|< 0.0001
71876271|NCT03627767|143271373|SUPERIORITY||Difference in percentage|19.2|||||TWO_SIDED|95.0|10.8|27.6||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||27.6|10.8|
71876272|NCT03627767|143271374|SUPERIORITY||Difference in percentage|2.6|||=|0.3994|TWO_SIDED|95.0|-3.3|8.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.4|-3.3|= 0.3994
71876273|NCT03627767|143271374|SUPERIORITY||Difference in percentage|1.8|||=|0.5542|TWO_SIDED|95.0|-4.1|7.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.8|-4.1|= 0.5542
71876274|NCT03627767|143271374|SUPERIORITY||Difference in percentage|-0.8|||||TWO_SIDED|95.0|-6.5|5.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.0|-6.5|
71876275|NCT03627767|143271374|SUPERIORITY||Difference in percentage|37.5|||<|0.0001|TWO_SIDED|95.0|30.2|44.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.9|30.2|< 0.0001
71876276|NCT03627767|143271374|SUPERIORITY||Difference in percentage|63.3|||<|0.0001|TWO_SIDED|95.0|56.8|69.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||69.8|56.8|< 0.0001
71876277|NCT03627767|143271374|SUPERIORITY||Difference in percentage|25.5|||||TWO_SIDED|95.0|17.7|33.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||33.4|17.7|
71876278|NCT03627767|143271374|SUPERIORITY||Difference in percentage|36.9|||<|0.0001|TWO_SIDED|95.0|29.9|44.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.0|29.9|< 0.0001
71876279|NCT03627767|143271374|SUPERIORITY||Difference in percentage|54.2|||<|0.0001|TWO_SIDED|95.0|47.3|61.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.0|47.3|< 0.0001
71684222|NCT03240406|142886390|SUPERIORITY||Mean Difference (Net)|0.01||||0.273|TWO_SIDED|95.0|-0.01|0.03||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.03|-0.01|0.273
71684223|NCT03240406|142886391|SUPERIORITY||Mean Difference (Net)|0.03||||0.116|TWO_SIDED|95.0|-0.01|0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.06|-0.01|0.116
71684224|NCT03240406|142886392|SUPERIORITY||Mean Difference (Net)|0.0||||0.213|TWO_SIDED|95.0|0.0|0.01||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.01|0|0.213
71684225|NCT03240406|142886393|SUPERIORITY||Mean Difference (Net)|0.05||||0.036|TWO_SIDED|95.0|0.0|0.09||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.09|0|0.036
71684226|NCT03240406|142886394|SUPERIORITY||Mean Difference (Net)|0.17||||0.223|TWO_SIDED|95.0|-0.1|0.43||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.43|-0.1|0.223
71684227|NCT03240406|142886395|SUPERIORITY||Mean Difference (Net)|-0.17||||0.119|TWO_SIDED|95.0|-0.38|0.04||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.04|-0.38|0.119
71684228|NCT03240406|142886396|SUPERIORITY||Mean Difference (Net)|-0.04||||0.841|TWO_SIDED|95.0|-0.41|0.33||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.33|-0.41|0.841
71684229|NCT03240406|142886397|SUPERIORITY||Mean Difference (Net)|0.25||||0.088|TWO_SIDED|95.0|-0.04|0.53||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.53|-0.04|0.088
71684230|NCT03240406|142886398|SUPERIORITY||Mean Difference (Net)|-0.01||||0.893|TWO_SIDED|95.0|-0.13|0.11||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||0.11|-0.13|0.893
71684231|NCT03240406|142886399|SUPERIORITY||Mean Difference (Net)|-1.43||||0.042|TWO_SIDED|95.0|-2.81|-0.06||MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|ANCOVA|MHD-Comparison difference in Burst 2 value estimated by ANCOVA, adjusted for Burst 1 value, age, sex, years of education|Mean Difference of MHD Arm vs Comparison Arm|||-0.06|-2.81|0.042
71876280|NCT03627767|143271374|SUPERIORITY||Difference in percentage|17.2|||||TWO_SIDED|95.0|8.9|25.5||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.5|8.9|
71916835|NCT04423718|143355314|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-1.14||||0.0011|TWO_SIDED|95.0|-2.97|0.69||Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.69|-2.97|0.0011
71684232|NCT03240406|142886400|SUPERIORITY||Slope|-16.0||||0.031|TWO_SIDED|95.0|-31.0|-1.5||Linear mixed-effects model adjusted for adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of processing speed over years between MHD Arm and Comparison Arm.|||-1.5|-31|0.031
71684233|NCT03240406|142886401|SUPERIORITY||Slope|0.12||||0.55|TWO_SIDED|95.0|-0.27|0.51||Linear mixed-effects model adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Mixed Models Analysis|Adjusted for arm, year, weekday, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), and time of day (cubic spline)|Difference in the slopes of error distance over years between MHD Arm vs Comparison Arm|||0.51|-0.27|0.55
71684234|NCT03240406|142886402|SUPERIORITY||Slope|-0.018||||0.846|TWO_SIDED|95.0|-0.09|0.054||Generalized Estimating equation Poisson model adjusted for arm, year, weekday vs weekend, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Generalized Estimating Equation|Adjusted for arm, year, wkday/wknd, season, EMA cognition, baseline age, sex, education yrs, # of sessions (cubic spline), time of day (cubic spline)|Difference in the slopes of log-transformed error rates over years between the MHD Arm and the Comparison Arm.|||0.054|-0.090|0.846
71684235|NCT02607306|142886403|NON_INFERIORITY|Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for non-inferiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
71684236|NCT02607306|142886403|SUPERIORITY|Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.|Treatment contrast|-0.48|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.37||p-value for superiority of IDegLira vs Lira is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.||-0.37|-0.60|<0.0001
71916836|NCT04423718|143355315|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.86||||0.0002|TWO_SIDED|95.0|-2.57|0.84||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.84|-2.57|0.0002
71876281|NCT03627767|143271374|SUPERIORITY||Difference in percentage|29.8|||<|0.0001|TWO_SIDED|95.0|22.7|37.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|22.7|< 0.0001
71876282|NCT03627767|143271374|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.6|53.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||53.8|39.6|< 0.0001
71876283|NCT03627767|143271374|SUPERIORITY||Difference in percentage|16.9|||||TWO_SIDED|95.0|8.5|25.3||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.3|8.5|
71876284|NCT03627767|143271374|SUPERIORITY||Difference in percentage|27.4|||<|0.0001|TWO_SIDED|95.0|20.4|34.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||34.3|20.4|< 0.0001
71876285|NCT03627767|143271374|SUPERIORITY||Difference in percentage|43.8|||<|0.0001|TWO_SIDED|95.0|36.7|50.9||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||50.9|36.7|< 0.0001
71876286|NCT03627767|143271374|SUPERIORITY||Difference in percentage|16.8|||||TWO_SIDED|95.0|8.4|25.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.2|8.4|
71876287|NCT03627767|143271375|SUPERIORITY||Difference in percentage|0.3|||=|0.9313|TWO_SIDED|95.0|-7.5|8.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.1|-7.5|= 0.9313
71876288|NCT03627767|143271375|SUPERIORITY||Difference in percentage|-2.1|||=|0.6043|TWO_SIDED|95.0|-9.8|5.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.7|-9.8|= 0.6043
71916837|NCT04423718|143355315|NON_INFERIORITY|One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin|Difference in LS means|-0.92|||<|0.0001|TWO_SIDED|95.0|-2.51|0.66||EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)|Mixed Models Analysis|Adjusted for baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.66|-2.51|<0.0001
71876289|NCT03627767|143271375|SUPERIORITY||Difference in percentage|-2.3|||||TWO_SIDED|95.0|-10.0|5.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-10.0|
71876290|NCT03627767|143271375|SUPERIORITY||Difference in percentage|11.6|||<|0.0001|TWO_SIDED|95.0|6.6|16.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.5|6.6|< 0.0001
71876291|NCT03627767|143271375|SUPERIORITY||Difference in percentage|25.3|||<|0.0001|TWO_SIDED|95.0|19.4|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|19.4|< 0.0001
71876292|NCT03627767|143271375|SUPERIORITY||Difference in percentage|13.5|||||TWO_SIDED|95.0|6.6|20.4||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.4|6.6|
71876293|NCT03627767|143271375|SUPERIORITY||Difference in percentage|12.9|||<|0.0001|TWO_SIDED|95.0|7.7|18.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||18.0|7.7|< 0.0001
71876294|NCT03627767|143271375|SUPERIORITY||Difference in percentage|26.0|||<|0.0001|TWO_SIDED|95.0|19.9|32.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||32.0|19.9|< 0.0001
71876295|NCT03627767|143271375|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|6.3|20.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.6|6.3|
71684237|NCT02607306|142886404|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-1.19||||0.0001|TWO_SIDED|95.0|-1.8|-0.59||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.||-0.59|-1.80|0.0001
71684238|NCT02607306|142886405|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|0.48|||<|0.0001|TWO_SIDED|95.0|0.35|0.68||p-value for superiority of IDegLira vs IDeg is presented|Negative binomial regression|||The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.||0.68|0.35|<0.0001
71684239|NCT02607306|142886406|SUPERIORITY|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-0.63|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.52||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.||-0.52|-0.75|<0.0001
71684240|NCT03759366|142886443|SUPERIORITY||Least Square Mean|-5.8||||0.0004|TWO_SIDED|95.0|-8.4|-3.13|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 26 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-3.13|-8.40|0.0004
71684241|NCT03759366|142886457|SUPERIORITY||Least Square Mean|-4.3||||0.0033|TWO_SIDED|95.0|-6.93|-1.65|||Repeated Measures Model||The least square mean change from baseline in QMG total score at Week 52 was calculated.|The observed change in QMG was analyzed with baseline QMG score and visits as covariates.||-1.65|-6.93|0.0033
71684242|NCT03334422|142886504|SUPERIORITY||Odds Ratio (OR)|2.58||||0.026|TWO_SIDED|95.0|1.12|5.92|||Regression, Logistic|||||5.92|1.12|0.026
71684243|NCT03334422|142886504|SUPERIORITY||Odds Ratio (OR)|3.64||||0.001|TWO_SIDED|95.0|1.64|8.05|||Regression, Logistic|||||8.05|1.64|0.001
71684244|NCT03334422|142886505|SUPERIORITY||Odds Ratio (OR)|2.13||||0.085|TWO_SIDED|95.0|0.9|5.02|||Regression, Logistic|||||5.02|0.90|0.085
71684245|NCT03334422|142886506|SUPERIORITY||Odds Ratio (OR)|2.35||||0.024|TWO_SIDED|95.0|1.12|4.93|||Regression, Logistic|||||4.93|1.12|0.024
71684246|NCT03334422|142886506|SUPERIORITY||Odds Ratio (OR)|3.49|||<|0.001|TWO_SIDED|95.0|1.73|7.04|||Regression, Logistic|||||7.04|1.73|<0.001
71684247|NCT03334422|142886506|SUPERIORITY||Odds Ratio (OR)|4.41|||<|0.001|TWO_SIDED|95.0|2.22|8.76|||Regression, Logistic|||||8.76|2.22|<0.001
71684248|NCT03334422|142886507|SUPERIORITY||Odds Ratio (OR)|2.8||||0.053|TWO_SIDED|95.0|0.99|7.97|||Regression, Logistic|||||7.97|0.99|0.053
71876296|NCT03627767|143271375|SUPERIORITY||Difference in percentage|11.7|||<|0.0001|TWO_SIDED|95.0|6.5|16.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||16.8|6.5|< 0.0001
71684249|NCT03334422|142886507|SUPERIORITY||Odds Ratio (OR)|3.87||||0.007|TWO_SIDED|95.0|1.44|10.41|||Regression, Logistic|||||10.41|1.44|0.007
71684250|NCT03334422|142886507|SUPERIORITY||Odds Ratio (OR)|6.2|||<|0.001|TWO_SIDED|95.0|2.42|15.91|||Regression, Logistic|||||15.91|2.42|<0.001
71684251|NCT03334422|142886508|SUPERIORITY||Mean Difference (Net)|-12.76|STANDARD_ERROR_OF_MEAN|6.81||0.062|TWO_SIDED|95.0|-26.19|0.66|||Mixed Models Analysis|||||0.66|-26.19|0.062
71684252|NCT03334422|142886508|SUPERIORITY||Mean Difference (Net)|-25.89|STANDARD_ERROR_OF_MEAN|6.54|<|0.001|TWO_SIDED|95.0|-38.78|-12.99|||Mixed Models Analysis|||||-12.99|-38.78|<0.001
71684253|NCT03334422|142886508|SUPERIORITY||Mean Difference (Net)|-25.97|STANDARD_ERROR_OF_MEAN|6.24|<|0.001|TWO_SIDED|95.0|-38.29|-13.65|||Mixed Models Analysis|||||-13.65|-38.29|<0.001
71684254|NCT03334422|142886509|SUPERIORITY||Odds Ratio (OR)|2.9||||0.086|TWO_SIDED|95.0|0.86|9.76|||Regression, Logistic|||||9.76|0.86|0.086
71684255|NCT03334422|142886509|SUPERIORITY||Odds Ratio (OR)|4.95||||0.006|TWO_SIDED|95.0|1.58|15.49|||Regression, Logistic|||||15.49|1.58|0.006
71684256|NCT03334422|142886509|SUPERIORITY||Odds Ratio (OR)|7.4|||<|0.001|TWO_SIDED|95.0|2.51|21.83|||Regression, Logistic|||||21.83|2.51|<0.001
71684257|NCT03334422|142886510|SUPERIORITY||Odds Ratio (OR)|1.41||||0.505|TWO_SIDED|95.0|0.51|3.87|||Regression, Logistic|||||3.87|0.51|0.505
71684258|NCT03334422|142886510|SUPERIORITY||Odds Ratio (OR)|3.64||||0.002|TWO_SIDED|95.0|1.6|8.27|||Regression, Logistic|||||8.27|1.60|0.002
71684259|NCT03334422|142886510|SUPERIORITY||Odds Ratio (OR)|4.91|||<|0.001|TWO_SIDED|95.0|2.22|10.86|||Regression, Logistic|||||10.86|2.22|<0.001
71876297|NCT03627767|143271375|SUPERIORITY||Difference in percentage|25.7|||<|0.0001|TWO_SIDED|95.0|19.6|31.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.8|19.6|< 0.0001
71684260|NCT03334422|142886511|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.15||0.074|TWO_SIDED|95.0|-0.57|0.03|||Mixed Models Analysis|||||0.03|-0.57|0.074
71684261|NCT03334422|142886511|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.15||0.011|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||||-0.09|-0.68|0.011
71684262|NCT03334422|142886511|SUPERIORITY||Mean Difference (Net)|-0.55|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.84|-0.26|||Mixed Models Analysis|||||-0.26|-0.84|<0.001
71684263|NCT03334422|142886512|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-1.05|0.59|||Mixed Models Analysis|||||0.59|-1.05|0.580
71684264|NCT03334422|142886512|SUPERIORITY||Mean Difference (Net)|-1.75|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.54|-0.96|||Mixed Models Analysis|||||-0.96|-2.54|<0.001
71684265|NCT03334422|142886512|SUPERIORITY||Mean Difference (Net)|-1.62|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.37|-0.87|||Mixed Models Analysis|||||-0.87|-2.37|<0.001
71684266|NCT03334422|142886513|SUPERIORITY||Odds Ratio (OR)|1.67||||0.094|TWO_SIDED|95.0|0.92|3.04|||Regression, Logistic|||||3.04|0.92|0.094
71684267|NCT03334422|142886513|SUPERIORITY||Odds Ratio (OR)|2.91|||<|0.001|TWO_SIDED|95.0|1.65|5.11|||Regression, Logistic|||||5.11|1.65|<0.001
71684268|NCT03334422|142886513|SUPERIORITY||Odds Ratio (OR)|3.15|||<|0.001|TWO_SIDED|95.0|1.8|5.51|||Regression, Logistic|||||5.51|1.80|<0.001
71684269|NCT03334422|142886514|SUPERIORITY||Odds Ratio (OR)|1.57||||0.528|TWO_SIDED|95.0|0.39|6.31|||Regression, Logistic|||||6.31|0.39|0.528
71684270|NCT03334422|142886514|SUPERIORITY||Odds Ratio (OR)|2.56||||0.142|TWO_SIDED|95.0|0.73|8.95|||Regression, Logistic|||||8.95|0.73|0.142
71684271|NCT03334422|142886514|SUPERIORITY||Odds Ratio (OR)|2.68||||0.123|TWO_SIDED|95.0|0.77|9.37|||Regression, Logistic|||||9.37|0.77|0.123
71684272|NCT03334422|142886515|SUPERIORITY||LSMean Difference|-6.88|STANDARD_ERROR_OF_MEAN|3.63||0.059|TWO_SIDED|95.0|-14.03|0.28|||Mixed Models Analysis|||||0.28|-14.03|0.059
71684273|NCT03334422|142886515|SUPERIORITY||LSMean Difference|-14.48|STANDARD_ERROR_OF_MEAN|3.47|<|0.001|TWO_SIDED|95.0|-21.32|-7.63|||Mixed Models Analysis|||||-7.63|-21.32|<0.001
71684274|NCT03334422|142886515|SUPERIORITY||LSMean Difference|-14.15|STANDARD_ERROR_OF_MEAN|3.32|<|0.001|TWO_SIDED|95.0|-20.69|-7.61|||Mixed Models Analysis|||||-7.61|-20.69|<0.001
71684275|NCT03334422|142886516|SUPERIORITY||Odds Ratio (OR)|2.55||||0.193|TWO_SIDED|95.0|0.62|10.45|||Regression, Logistic|||||10.45|0.62|0.193
71684276|NCT03334422|142886516|SUPERIORITY||Odds Ratio (OR)|4.1||||0.042|TWO_SIDED|95.0|1.05|16.03|||Mixed Models Analysis|||||16.03|1.05|0.042
71684277|NCT03334422|142886516|SUPERIORITY||Odds Ratio (OR)|3.89||||0.044|TWO_SIDED|95.0|1.04|14.57|||Regression, Logistic|||||14.57|1.04|0.044
71684278|NCT03334422|142886517|SUPERIORITY||LSMean Difference|-6.16|STANDARD_ERROR_OF_MEAN|3.23||0.058|TWO_SIDED|95.0|-12.53|0.21|||Mixed Models Analysis|||||0.21|-12.53|0.058
71684279|NCT03334422|142886517|SUPERIORITY||LSMean Difference|-9.3|STANDARD_ERROR_OF_MEAN|3.1||0.003|TWO_SIDED|95.0|-15.42|-3.18|||Mixed Models Analysis|||||-3.18|-15.42|0.003
71684280|NCT03334422|142886517|SUPERIORITY||LSMean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.98|<|0.001|TWO_SIDED|95.0|-17.03|-5.3|||Mixed Models Analysis|||||-5.30|-17.03|<0.001
71684281|NCT03334422|142886518|SUPERIORITY|||||||0.189|||||||Fisher Exact|||||||0.189
71876298|NCT03627767|143271375|SUPERIORITY||Difference in percentage|14.1|||||TWO_SIDED|95.0|7.0|21.2||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.2|7.0|
71876299|NCT03627767|143271375|SUPERIORITY||Difference in percentage|14.6|||<|0.0001|TWO_SIDED|95.0|9.2|20.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||20.0|9.2|< 0.0001
71684282|NCT03334422|142886518|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71684283|NCT03334422|142886518|SUPERIORITY|||||||0.383|||||||Fisher Exact|||||||0.383
71684284|NCT03334422|142886519|SUPERIORITY||LSMean Difference|-14.8|STANDARD_ERROR_OF_MEAN|8.46||0.081|TWO_SIDED|95.0|-31.45|1.85|||Mixed Models Analysis|||||1.85|-31.45|0.081
71684285|NCT03334422|142886519|SUPERIORITY||LSMean Difference|-30.66|STANDARD_ERROR_OF_MEAN|8.11|<|0.001|TWO_SIDED|95.0|-46.62|-14.7|||Mixed Models Analysis|||||-14.70|-46.62|<0.001
71684286|NCT03334422|142886519|SUPERIORITY||LSMean Difference|-30.28|STANDARD_ERROR_OF_MEAN|7.63|<|0.001|TWO_SIDED|95.0|-45.29|-15.27|||Mixed Models Analysis|||||-15.27|-45.29|<0.001
71684287|NCT03334422|142886520|SUPERIORITY||LSMean Difference|-2.36|STANDARD_ERROR_OF_MEAN|1.32||0.075|TWO_SIDED|95.0|-4.97|0.24|||Mixed Models Analysis|||||0.24|-4.97|0.075
71684288|NCT03334422|142886520|SUPERIORITY||LSMean Difference|-5.58|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|-8.07|-3.08|||Mixed Models Analysis|||||-3.08|-8.07|<0.001
71684289|NCT03334422|142886520|SUPERIORITY||LSMean Difference|-6.07|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-8.47|-3.68|||Mixed Models Analysis|||||-3.68|-8.47|<0.001
71684290|NCT03334422|142886521|SUPERIORITY||LSMean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.17||0.13|TWO_SIDED|95.0|-0.61|0.08|||Mixed Models Analysis|||||0.08|-0.61|0.130
71684291|NCT03334422|142886521|SUPERIORITY||LSMean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-0.94|-0.28|||Mixed Models Analysis|||||-0.28|-0.94|<0.001
71684292|NCT03334422|142886521|SUPERIORITY||LSMean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.0|-0.38|||Mixed Models Analysis|||||-0.38|-1.00|<0.001
71684293|NCT03334422|142886522|SUPERIORITY||LSMean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.51||0.067|TWO_SIDED|95.0|-1.95|0.07|||Mixed Models Analysis|||HADS Anxiety.||0.07|-1.95|0.067
71684294|NCT03334422|142886522|SUPERIORITY||LSMean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.06|TWO_SIDED|95.0|-1.89|0.04|||Mixed Models Analysis|||HADS Anxiety.||0.04|-1.89|0.060
71684295|NCT03334422|142886522|SUPERIORITY||LSMean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.47||0.006|TWO_SIDED|95.0|-2.23|-0.38|||Mixed Models Analysis|||HADS Anxiety.||-0.38|-2.23|0.006
71684296|NCT03334422|142886522|SUPERIORITY||LSMean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.51||0.321|TWO_SIDED|95.0|-1.5|0.49|||Mixed Models Analysis|||HADS Depression.||0.49|-1.50|0.321
71684297|NCT03334422|142886522|SUPERIORITY||LSMean Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.49||0.143|TWO_SIDED|95.0|-1.67|0.24|||Mixed Models Analysis|||HADS Depression.||0.24|-1.67|0.143
71684298|NCT03334422|142886522|SUPERIORITY||LSMean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.47||0.012|TWO_SIDED|95.0|-2.11|-0.26|||Mixed Models Analysis|||HADS Depression.||-0.26|-2.11|0.012
71684299|NCT03334422|142886523|SUPERIORITY||LSMean Difference|-1.76|STANDARD_ERROR_OF_MEAN|0.97||0.071|TWO_SIDED|95.0|-3.67|0.15|||Mixed Models Analysis|||||0.15|-3.67|0.071
71684300|NCT03334422|142886523|SUPERIORITY||LSMean Difference|-4.09|STANDARD_ERROR_OF_MEAN|0.93|<|0.001|TWO_SIDED|95.0|-5.92|-2.26|||Mixed Models Analysis|||||-2.26|-5.92|<0.001
71684301|NCT03334422|142886523|SUPERIORITY||LSMean Difference|-4.22|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.98|-2.45|||Mixed Models Analysis|||||-2.45|-5.98|<0.001
71684302|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-0.91|STANDARD_ERROR_OF_MEAN|5.17||0.861|TWO_SIDED|95.0|-11.16|9.34|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||9.34|-11.16|0.861
71684303|NCT03334422|142886524|SUPERIORITY||LSMean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.03||0.841|TWO_SIDED|95.0|-8.94|10.97||Absenteeism|Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||10.97|-8.94|0.841
71684304|NCT03334422|142886524|SUPERIORITY||LSMean Difference|5.16|STANDARD_ERROR_OF_MEAN|4.6||0.264|TWO_SIDED|95.0|-3.95|14.26|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline||14.26|-3.95|0.264
71876300|NCT03627767|143271375|SUPERIORITY||Difference in percentage|24.5|||<|0.0001|TWO_SIDED|95.0|18.4|30.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.5|18.4|< 0.0001
71684305|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-3.12|STANDARD_ERROR_OF_MEAN|5.63||0.58|TWO_SIDED|95.0|-14.26|8.02|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||8.02|-14.26|0.580
71684306|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-13.56|STANDARD_ERROR_OF_MEAN|5.5||0.015|TWO_SIDED|95.0|-24.45|-2.86|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-2.86|-24.45|0.015
71684307|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-13.13|STANDARD_ERROR_OF_MEAN|5.08||0.011|TWO_SIDED|95.0|-23.2|-3.06|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline||-3.06|-23.20|0.011
71684308|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-1.81|STANDARD_ERROR_OF_MEAN|6.71||0.788|TWO_SIDED|95.0|-15.12|11.49|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||11.49|-15.12|0.788
71684309|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-9.48|STANDARD_ERROR_OF_MEAN|6.57||0.152|TWO_SIDED|95.0|-22.51|3.55|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||3.55|-22.51|0.152
71684310|NCT03334422|142886524|SUPERIORITY|Overall Work Impairment|LSMean Difference|-9.13|STANDARD_ERROR_OF_MEAN|6.07||0.135|TWO_SIDED|95.0|-21.17|2.9|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline||2.90|-21.17|0.135
71684311|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-2.26|STANDARD_ERROR_OF_MEAN|4.25||0.595|TWO_SIDED|95.0|-10.65|6.12|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||6.12|-10.65|0.595
71684312|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-14.3|STANDARD_ERROR_OF_MEAN|4.12|<|0.001|TWO_SIDED|95.0|-22.43|-6.17|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.17|-22.43|<0.001
71684313|NCT03334422|142886524|SUPERIORITY||LSMean Difference|-14.47|STANDARD_ERROR_OF_MEAN|3.88|<|0.001|TWO_SIDED|95.0|-22.11|-6.83|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline||-6.83|-22.11|<0.001
71684314|NCT03334422|142886525|SUPERIORITY||LSMean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.295|TWO_SIDED|95.0|-0.02|0.07|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.07|-0.02|0.295
71684315|NCT03334422|142886525|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02||0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|0.001
71684316|NCT03334422|142886525|SUPERIORITY||LSMean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)||0.12|0.03|<0.001
71684317|NCT03334422|142886525|SUPERIORITY||LSMean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.334|TWO_SIDED|95.0|-0.03|0.1|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.10|-0.03|0.334
71684318|NCT03334422|142886525|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03||0.001|TWO_SIDED|95.0|0.04|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.04|0.001
71684319|NCT03334422|142886525|SUPERIORITY||LSMean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.03|<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)||0.17|0.05|<0.001
71684320|NCT03334422|142886526|SUPERIORITY||LSMean Difference|0.4|STANDARD_ERROR_OF_MEAN|3.47||0.907|TWO_SIDED|95.0|-6.44|7.25|||Mixed Models Analysis|||EQ-5D-5L VAS Score||7.25|-6.44|0.907
71684321|NCT03334422|142886526|SUPERIORITY||LSMean Difference|8.19|STANDARD_ERROR_OF_MEAN|3.33||0.015|TWO_SIDED|95.0|1.63|14.76|||Mixed Models Analysis|||EQ-5D-5L VAS Score||14.76|1.63|0.015
71684322|NCT03334422|142886526|SUPERIORITY||LSMean Difference|8.82|STANDARD_ERROR_OF_MEAN|3.14||0.006|TWO_SIDED|95.0|2.62|15.01|||Mixed Models Analysis|||EQ-5D-5L VAS Score||15.01|2.62|0.006
71684323|NCT03334422|142886527|SUPERIORITY||Odds Ratio (OR)|0.93||||0.905|TWO_SIDED|95.0|0.3|2.93|||Regression, Logistic|||||2.93|0.30|0.905
71684324|NCT03334422|142886527|SUPERIORITY||Odds Ratio (OR)|2.37||||0.064|TWO_SIDED|95.0|0.95|5.92|||Regression, Logistic|||||5.92|0.95|0.064
71684325|NCT03334422|142886527|SUPERIORITY||Odds Ratio (OR)|5.14|||<|0.001|TWO_SIDED|95.0|2.25|11.74|||Regression, Logistic|||||11.74|2.25|<0.001
71684326|NCT04591015|142886538|SUPERIORITY|||||||0.0626|||||||Fisher Exact|||||||0.0626
71684327|NCT04591015|142886539|SUPERIORITY|||||||0.0496|||||||t-test, 2 sided|||Only includes participants who completed a 90-day lab||||0.0496
71684328|NCT04591015|142886540|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||Only includes participants who completed a 180-day lab||||0.0651
71684329|NCT04591015|142886541|SUPERIORITY|||||||0.8739|||||||Fisher Exact|||||||0.8739
71684330|NCT04591015|142886542|SUPERIORITY|||||||0.4702|||||||t-test, 2 sided|||||||0.4702
71684331|NCT04591015|142886543|SUPERIORITY|||||||0.1258|||||||t-test, 2 sided|||||||0.1258
71684332|NCT04591015|142886544|SUPERIORITY|||||||0.8635|||||||t-test, 2 sided|||||||0.8635
71684333|NCT04591015|142886545|SUPERIORITY|||||||0.0471|||||||t-test, 2 sided|||||||0.0471
71684334|NCT04591015|142886546|SUPERIORITY|||||||0.0218|||||||t-test, 2 sided|||||||0.0218
71684335|NCT04591015|142886547|SUPERIORITY|||||||0.509|||||||t-test, 2 sided|||||||0.5090
71684336|NCT04591015|142886548|SUPERIORITY|||||||0.4034|||||||t-test, 2 sided|||||||0.4034
71684337|NCT04591015|142886549|SUPERIORITY|||||||0.0175|||||||t-test, 2 sided|||||||0.0175
71684338|NCT04591015|142886550|SUPERIORITY|||||||0.4435|||||||Fisher Exact|||||||0.4435
71684339|NCT04591015|142886551|SUPERIORITY|||||||0.7417|||||||Fisher Exact|||||||0.7417
71684340|NCT04591015|142886552|SUPERIORITY|||||||0.5779|||||||t-test, 2 sided|||||||0.5779
71684341|NCT04591015|142886553|SUPERIORITY|||||||0.0493|||||||t-test, 2 sided|||||||0.0493
71684342|NCT04591015|142886554|SUPERIORITY|||||||0.0773|||||||t-test, 2 sided|||||||0.0773
71684343|NCT04591015|142886555|SUPERIORITY|||||||0.0921|||||||t-test, 2 sided|||||||0.0921
71684344|NCT04591015|142886556|SUPERIORITY|||||||0.2404|||||||t-test, 2 sided|||||||0.2404
71684345|NCT04591015|142886557|SUPERIORITY|||||||0.8955|||||||t-test, 2 sided|||||||0.8955
71684346|NCT02509078|142886558|SUPERIORITY||Risk Difference (RD)|-0.3||||0.93|TWO_SIDED|95.0|-6.4|5.9|||Wald test for the difference of two prop||Estimated value is a percentage|||5.9|-6.4|0.93
71684347|NCT02686814|142886589|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-0.9||||0.7646|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.7646
71684348|NCT02686814|142886589|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|3.9||||0.8984|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.8984
71684349|NCT02686814|142886589|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.0||||0.8457|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.8457
71684350|NCT02686814|142886589|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-7.7||||0.1309|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.1309
71684351|NCT02686814|142886589|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|-15.2||||0.5|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||0.5000
71684352|NCT02686814|142886590|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.5||||0.2783|TWO_SIDED||||||Wilcoxon signed-rank test|||3-6 Month compared to Baseline||||0.2783
71684353|NCT02686814|142886590|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0674|TWO_SIDED||||||Wilcoxon signed-rank test|||1 Year compared to Baseline||||0.0674
71684354|NCT02686814|142886590|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|6.4||||0.0371|TWO_SIDED||||||Wilcoxon signed-rank test|||2 Year compared to Baseline||||0.0371
71684355|NCT02686814|142886590|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|0.8||||0.6953|TWO_SIDED||||||Wilcoxon signed-rank test|||3 Year compared to Baseline||||0.6953
71916838|NCT04423718|143355316|SUPERIORITY|One sided test (alpha = 0.025) for superiority|Difference|11.733||||0.0002|TWO_SIDED|95.0|5.263|18.204||Strictly hierarchical testing procedure to adjust for multiplicity.|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|All HD - 2q8||18.204|5.263|0.0002
71916839|NCT04423718|143355317|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-1.748||||0.5704|TWO_SIDED|95.0|-7.784|4.287||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||4.287|-7.784|0.5704
71916840|NCT04423718|143355317|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.939||||0.7611|TWO_SIDED|95.0|-6.997|5.119||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||5.119|-6.997|0.7611
71916841|NCT04423718|143355318|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-0.182||||0.9554|TWO_SIDED|95.0|-6.565|6.2||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||6.200|-6.565|0.9554
71916842|NCT04423718|143355318|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|-2.221||||0.4834|TWO_SIDED|95.0|-8.435|3.994||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||3.994|-8.435|0.4834
71916843|NCT04423718|143355319|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-1.22||||0.0009|TWO_SIDED|95.0|-1.94|-0.51||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.51|-1.94|0.0009
71916844|NCT04423718|143355319|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.48||||0.2076|TWO_SIDED|95.0|-1.22|0.27||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CNV size and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.27|-1.22|0.2076
71684356|NCT02686814|142886590|EQUIVALENCE|Each of the scales, for each follow-up time compared to baseline, the null hypothesis that the median paired difference is zero will be tested against the two-sided alternative that the median is not zero. Wilcoxon signed-rank test will be used.|Median Difference (Final Values)|1.0|||>|0.9999|TWO_SIDED||||||Wilcoxon signed-rank test|||4 Year compared to Baseline||||>0.9999
71684357|NCT02603107|142886646|NON_INFERIORITY|A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in Percentages|0.0|||||TWO_SIDED|95.002|-2.5|2.5|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.||2.5|-2.5|
71684358|NCT02603107|142886646|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71916845|NCT04423718|143355320|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.55||||0.0287|TWO_SIDED|95.0|-1.04|-0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-0.06|-1.04|0.0287
71916846|NCT04423718|143355320|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.44||||0.087|TWO_SIDED|95.0|-0.94|0.06||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline total lesion area and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.06|-0.94|0.0870
71916847|NCT04423718|143355321|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|11.725||||0.0015|TWO_SIDED|95.0|4.527|18.923||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq12 - 2q8||18.923|4.527|0.0015
71916848|NCT04423718|143355321|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference|7.451||||0.0458|TWO_SIDED|95.0|0.142|14.76||Nominal p-value, not adjusted for multiplicity|Cochran-Mantel-Haenszel|CMH test stratified by baseline BCVA and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach|HDq16 - 2q8||14.760|0.142|0.0458
71916849|NCT04423718|143355322|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-11.12||||0.0283|TWO_SIDED|95.0|-21.06|-1.18||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||-1.18|-21.06|0.0283
71916850|NCT04423718|143355322|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-10.51||||0.0321|TWO_SIDED|95.0|-20.12|-0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline CST and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||-0.90|-20.12|0.0321
71916851|NCT04423718|143355323|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.72||||0.3817|TWO_SIDED|95.0|-2.35|0.9||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq12 - 2q8||0.90|-2.35|0.3817
71916852|NCT04423718|143355323|EQUIVALENCE|Two sided test (alpha = 0.05)|Difference in LS means|-0.87||||0.307|TWO_SIDED|95.0|-2.55|0.8||Nominal p-value, not adjusted for multiplicity|Mixed Models Analysis|Adjusted for baseline NEI-VFQ-25 total score and randomization strata|Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM|HDq16 - 2q8||0.80|-2.55|0.3070
71916853|NCT00425945|143355327|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|95.0|-0.1|14.9||||||||14.9|-0.1|
71916854|NCT00425945|143355328|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.4|||||TWO_SIDED|95.0|-2.1|10.8||||||||10.8|-2.1|
71916855|NCT00425945|143355329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-1.7|2.5||||||||2.5|-1.7|
71916856|NCT00425945|143355330|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.2|||||TWO_SIDED|95.0|-2.3|38.7||||||||38.7|-2.3|
71916857|NCT00425945|143355331|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.1|0.3||||||||0.3|-0.1|
71916858|NCT00425945|143355332|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|0.0|0.1||||||||0.1|-0.0|
71916859|NCT00425945|143355333|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.2|||||TWO_SIDED|95.0|-6.8|0.5||||||||0.5|-6.8|
71916860|NCT00425945|143355334|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.5|0.5||||||||0.5|-1.5|
71916861|NCT00425945|143355335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|0.0|0.4||||||||0.4|0.0|
71916862|NCT00425945|143355336|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|0.1|2.4||||||||2.4|0.1|
71916863|NCT00425945|143355337|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-4.4|2.3||||||||2.3|-4.4|
71916864|NCT00425945|143355338|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|-0.9|2.5||||||||2.5|-0.9|
71876301|NCT03627767|143271375|SUPERIORITY||Difference in percentage|10.0|||||TWO_SIDED|95.0|2.7|17.2||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||17.2|2.7|
71876302|NCT03627767|143271376|SUPERIORITY||Difference in percentage|1.8|||=|0.6082|TWO_SIDED|95.0|-5.0|8.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.5|-5.0|= 0.6082
71876303|NCT03627767|143271376|SUPERIORITY||Difference in percentage|0.2|||=|0.964|TWO_SIDED|95.0|-6.7|7.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||7.0|-6.7|= 0.9640
71876304|NCT03627767|143271376|SUPERIORITY||Difference in percentage|-2.4|||||TWO_SIDED|95.0|-9.1|4.4||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||4.4|-9.1|
71876305|NCT03627767|143271376|SUPERIORITY||Difference in percentage|38.9|||<|0.0001|TWO_SIDED|95.0|31.2|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|31.2|< 0.0001
71876306|NCT03627767|143271376|SUPERIORITY||Difference in percentage|59.7|||<|0.0001|TWO_SIDED|95.0|52.7|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|52.7|< 0.0001
71876307|NCT03627767|143271376|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|12.7|29.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.0|12.7|
71916865|NCT00425945|143355339|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.1|0.1||||||||0.1|-0.1|
71876308|NCT03627767|143271376|SUPERIORITY||Difference in percentage|33.9|||<|0.0001|TWO_SIDED|95.0|26.6|41.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.2|26.6|< 0.0001
71876309|NCT03627767|143271376|SUPERIORITY||Difference in percentage|55.3|||<|0.0001|TWO_SIDED|95.0|48.2|62.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||62.3|48.2|< 0.0001
71876310|NCT03627767|143271376|SUPERIORITY||Difference in percentage|21.7|||||TWO_SIDED|95.0|13.2|30.2||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.2|13.2|
71876311|NCT03627767|143271376|SUPERIORITY||Difference in percentage|29.7|||<|0.0001|TWO_SIDED|95.0|22.7|36.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||36.7|22.7|< 0.0001
71876312|NCT03627767|143271376|SUPERIORITY||Difference in percentage|45.5|||<|0.0001|TWO_SIDED|95.0|38.4|52.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||52.7|38.4|< 0.0001
71876313|NCT03627767|143271376|SUPERIORITY||Difference in percentage|16.0|||||TWO_SIDED|95.0|7.4|24.6||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.6|7.4|
71876314|NCT03627767|143271376|SUPERIORITY||Difference in percentage|19.9|||<|0.0001|TWO_SIDED|95.0|13.0|26.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.8|13.0|< 0.0001
71916866|NCT00425945|143355340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8|||||TWO_SIDED|95.0|-1.6|9.3||||||||9.3|-1.6|
71916867|NCT00425945|143355341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-3.4|0.8||||||||0.8|-3.4|
71916868|NCT05618808|143355342|SUPERIORITY||Posterior Odds Ratio|0.78|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
71916869|NCT05618808|143355345|SUPERIORITY||Posterior Odds Ratio|0.44|||||TWO_SIDED|90.0|0.16|1.61|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.61|0.16|
71916870|NCT05618808|143355346|SUPERIORITY||Posterior Odds Ratio|0.79|||||TWO_SIDED|90.0|0.47|1.32|||||REGN9933 vs Enoxaparin||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|1.32|0.47|
71916871|NCT05618808|143355352|SUPERIORITY||Posterior Odds Ratio|0.54|||||TWO_SIDED|90.0|0.32|0.95|||||Enoxaparin vs Apixaban||"Bayesian Logistic Regression; Confidence Interval refers to Credible Interval"|0.95|0.32|
71684359|NCT02603107|142886647|NON_INFERIORITY|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|3.2|||||TWO_SIDED|95.002|-1.6|8.2|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||8.2|-1.6|
71684360|NCT02603107|142886647|SUPERIORITY|||||||0.2|||||||Fisher Exact|||||||0.20
71684361|NCT02603107|142886648|SUPERIORITY||Difference in Least Squares Means (LSM)|25.0||||0.068|TWO_SIDED|95.0|-2.0|52.0|||ANOVA|||||52|-2|0.068
71684362|NCT03411902|142886650|SUPERIORITY|||||||0.048|||||||Mixed Models Analysis|||||||0.048
71684363|NCT03411902|142886651|SUPERIORITY|||||||0.745|||||||Mixed Models Analysis|||||||0.745
71684364|NCT03411902|142886652|SUPERIORITY|||||||0.163|||||||Mixed Models Analysis|||||||0.163
71684365|NCT03411902|142886653|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71916872|NCT01426009|143355421|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0723|STANDARD_ERROR_OF_MEAN|0.0188||0.0003|TWO_SIDED|95.0|0.0347|0.1099|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence. A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1099|0.0347|0.0003
71916873|NCT01426009|143355421|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0676|STANDARD_ERROR_OF_MEAN|0.0184||0.0006|TWO_SIDED|95.0|0.0307|0.1046|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1046|0.0307|0.0006
71916874|NCT01426009|143355421|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1021|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0644|0.1398|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1398|0.0644|<0.0001
71916875|NCT01426009|143355421|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0918|0.1681|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||00.1681|0.0918|<0.0001
71916876|NCT01426009|143355421|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0446|STANDARD_ERROR_OF_MEAN|0.0186||0.02|TWO_SIDED|95.0|0.0073|0.082|||Mantel Haenszel||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0820|0.0073|0.0200
71916877|NCT01426009|143355421|SUPERIORITY|Day 7 analysis|Least Squares Mean Difference (SE)|0.0813|STANDARD_ERROR_OF_MEAN|0.0284||0.006|TWO_SIDED|95.0|0.0243|0.1382|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1382|0.0243|0.0060
71684366|NCT03411902|142886654|SUPERIORITY|||||||0.337|||||||Mixed Models Analysis|||Pertaining to Radius 33 BMD||||0.337
71684367|NCT03411902|142886654|SUPERIORITY|||||||0.238|||||||Mixed Models Analysis|||Pertaining to Radius UD BMD||||0.238
71684368|NCT03411902|142886655|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.860
71684369|NCT00419159|142886661|OTHER||Odds Ratio (OR)|1.8||||0.253|TWO_SIDED|95.0|0.657|4.929|||Unadjusted Logistic Regression|||||4.929|0.657|0.253
71684370|NCT00419159|142886662|OTHER||Odds Ratio (OR)|0.382||||0.07|TWO_SIDED|95.0|0.135|1.083|||Unadjusted Logistic Regression|||||1.083|0.135|0.070
71684371|NCT00419159|142886663|OTHER||Hazard Ratio (HR)|0.814||||0.399|TWO_SIDED|95.0|0.505|1.312|||Unadjusted Logistic Regression|||||1.312|0.505|0.399
71684372|NCT00419159|142886663|OTHER||Hazard Ratio, log|1.001||||0.995|TWO_SIDED|95.0|0.62|1.617|||Unadjusted Logistic Regression|||||1.617|0.620|0.995
71684373|NCT00419159|142886664|OTHER||Hazard Ratio, log|1.203||||0.441|TWO_SIDED|95.0|0.752|1.923|||Unadjusted Logistic Regression|||||1.923|0.752|0.441
71684374|NCT00419159|142886664|OTHER||Hazard Ratio, log|1.547||||0.126|TWO_SIDED|95.0|0.884|2.708|||Unadjusted Logistic Regression|||||2.708|0.884|0.126
71684375|NCT00419159|142886665|OTHER||Odds Ratio (OR)|0.529||||0.238|TWO_SIDED|95.0|0.184|1.523|||Unadjusted Logistic Regression|||||1.523|0.184|0.238
71684376|NCT00419159|142886666|OTHER||Odds Ratio (OR)|1.044||||0.938|TWO_SIDED|95.0|0.352|3.099|||Unadjusted Logistic Regression|||||3.099|0.352|0.938
71876315|NCT03627767|143271376|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|32.8|48.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.1|32.8|< 0.0001
71916878|NCT01426009|143355421|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0385|STANDARD_ERROR_OF_MEAN|0.0183||0.0402|TWO_SIDED|95.0|0.0018|0.0752|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0752|0.0018|0.0402
71916879|NCT01426009|143355421|SUPERIORITY|Day 1 analysis|Least Squares Mean Difference (SE)|0.0696|STANDARD_ERROR_OF_MEAN|0.0179||0.0003|TWO_SIDED|95.0|0.0337|0.1055|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.1055|0.0337|0.0003
71916880|NCT01426009|143355421|SUPERIORITY|Day 1 analysis|Least Squares Mean|0.0501|STANDARD_ERROR_OF_MEAN|0.018||0.0074|TWO_SIDED|95.0|0.014|0.0861|||ANCOVA|||An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.||0.0861|0.0140|0.0074
71916881|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0767|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0505|0.1028|||ANCOVA||standard error of the mean difference|ACU 0-24 on Day 1||0.1028|0.0505|<0.0001
71916882|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.122|STANDARD_ERROR_OF_MEAN|0.0127|<|0.0001|TWO_SIDED|95.0|0.0965|0.1475|||ANCOVA||standard error of the Mean difference|ACU 0-24 Day 1||0.1475|0.0965|<0.0001
71916883|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1222|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.0965|0.1479|||ANCOVA||standard error of the Mean difference|AUC 0-24 Day 1||0.1479|0.0965|<0.0001
71684377|NCT00419159|142886667|OTHER||Hazard Ratio (HR)|1.474||||0.145|TWO_SIDED|95.0|0.875|2.484|||Unadjusted Cox Model|||||2.484|0.875|0.145
71916884|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1625|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.1362|0.1888|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1888|0.1362|<0.0001
71916885|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.169|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1434|0.1946|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1946|0.1434|<0.0001
71916886|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0189|<|0.0001|TWO_SIDED|95.0|0.0716|0.1473|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1||0.1473|0.0716|<0.0001
71916887|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1095|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|0.0812|0.1379|||ANCOVA||standard error of the Mean difference|AUC 0-24 on Day 7||0.1379|0.0812|<0.0001
71916888|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1271|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.0993|0.1548|||ANCOVA||standard error of the Mean difference|AUC0-24 on Day 7||0.1548|0.0993|<0.0001
71916889|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.145|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1169|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1169|<0.0001
71916890|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1688|STANDARD_ERROR_OF_MEAN|0.0142|<|0.0001|TWO_SIDED|95.0|0.1403|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.1403|<0.0001
71916891|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1396|STANDARD_ERROR_OF_MEAN|0.0139|<|0.0001|TWO_SIDED|95.0|0.1117|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1730|0.1117|<0.0001
71916892|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1183|STANDARD_ERROR_OF_MEAN|0.0194|<|0.0001|TWO_SIDED|95.0|0.0795|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7||0.1972|0.0795|<0.0001
71916893|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1038|STANDARD_ERROR_OF_MEAN|0.0131|<|0.0001|TWO_SIDED|95.0|0.0776|0.1301|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1301|0.0776|<0.0001
71916894|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1468|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1212|0.1724|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1724|0.1212|<0.0001
71916895|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1579|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1322|0.1837|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1837|0.1322|<0.0001
71916896|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1919|STANDARD_ERROR_OF_MEAN|0.0132|<|0.0001|TWO_SIDED|95.0|0.1655|0.2184|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2184|0.1655|<0.0001
71916897|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1994|STANDARD_ERROR_OF_MEAN|0.0128|<|0.0001|TWO_SIDED|95.0|0.1738|0.2251|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.2251|0.1738|<0.0001
71684378|NCT00419159|142886667|OTHER||Hazard Ratio, log|1.151||||0.583|TWO_SIDED|95.0|0.696|1.903|||Unadjusted Cox Model|||||1.903|0.696|0.583
71684379|NCT00419159|142886668|OTHER||Hazard Ratio (HR)|0.868||||0.588|TWO_SIDED|95.0|0.521|1.447|||Unadjusted Cox Model|||||1.447|0.521|0.588
71684380|NCT00419159|142886668|OTHER||Hazard Ratio (HR)|0.611||||0.148|TWO_SIDED|95.0|0.314|1.191|||Unadjusted Cox Model|||||1.191|0.314|0.148
71684381|NCT00187278|142886669|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.926||||0.3492|TWO_SIDED|95.0|0.789|1.0088||adjusted p|Regression, Cox|||||1.0088|0.789|0.3492
71876316|NCT03627767|143271376|SUPERIORITY||Difference in percentage|20.9|||||TWO_SIDED|95.0|11.8|30.0||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.0|11.8|
71876317|NCT03627767|143271379|SUPERIORITY||LSM difference|0.0|||=|0.9207|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The least squares mean (LSM) differences between treatment groups were derived from the statistical model. Mixed model repeated measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9207
71876318|NCT03627767|143271379|SUPERIORITY||LSM difference|0.0|||=|0.9998|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|= 0.9998
71876319|NCT03627767|143271379|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.3|0.3||||||Pruritus VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.3|
71876320|NCT03627767|143271379|SUPERIORITY||LSM difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.7|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.5|< 0.0001
71876321|NCT03627767|143271379|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.8|||Mixed Models Analysis|||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.8|-3.6|< 0.0001
71876322|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.1|||||TWO_SIDED|95.0|-1.4|-0.7||||||Pruritus VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.4|
71876323|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-2.0|-0.8|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-2.0|< 0.0001
71876324|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.3|||Mixed Models Analysis|||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-2.5|< 0.0001
71876325|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.9|-0.1||||||Pruritus VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.9|
71876326|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.0|||=|0.0039|TWO_SIDED|95.0|-1.7|-0.3|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.7|= 0.0039
71876327|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.2|||Mixed Models Analysis|||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.5|< 0.0001
71876328|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.3|-0.4||||||Pruritus VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.3|
71876329|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.5|||=|0.1488|TWO_SIDED|95.0|-1.2|0.2|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.2|= 0.1488
71684382|NCT00187278|142886670|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.878||||0.0882|TWO_SIDED|95.0|0.756|1.02||adjusted p|Regression, Cox|||||1.020|0.756|0.0882
71684383|NCT00187278|142886671|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.8215|TWO_SIDED|95.0|0.74|1.27|||Regression, Cox|||||1.27|0.74|0.8215
71684384|NCT00803205|142886686|SUPERIORITY|||||||0.3264|||||||ANOVA|||||||0.3264
71876330|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.3|||=|0.0003|TWO_SIDED|95.0|-2.0|-0.6|||Mixed Models Analysis|||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.0|= 0.0003
71684385|NCT00803205|142886687|SUPERIORITY||Mean Difference (Final Values)|2.754|STANDARD_ERROR_OF_MEAN|1.78124||0.1235|TWO_SIDED|95.0|-0.756|6.264||The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.|Mixed Models Analysis|||Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.||6.2640|-0.7560|0.1235
71684386|NCT00379808|142886710|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.22|||||||Wilcoxon sign rank test|||Statistical power was calculated using G\*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.||||0.22
71684387|NCT00379808|142886711|SUPERIORITY_OR_OTHER||percent difference|3.8||||0.57|||||||Wilcoxon sign rank|||Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint||||0.57
71684388|NCT00379808|142886712|SUPERIORITY_OR_OTHER||percent difference|7.4||||0.33|||||||wilcoxon sign rank|||The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.||||0.33
71684389|NCT00379808|142886713|SUPERIORITY_OR_OTHER||percent difference|11.9||||0.12|||||||Wilcoxon|||null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.||||0.12
71684390|NCT00379808|142886714|SUPERIORITY_OR_OTHER||percent difference|13.3||||0.03|||||||wilcoxon sign rank test|||null hypothesis is that montelukast does not affect IL1ra.||||0.03
71684391|NCT00379808|142886715|SUPERIORITY_OR_OTHER||percent difference|16.5||||0.09|||||||wilcoxon sign rank|||null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker||||0.09
71684392|NCT01432561|142886716|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.04
71684393|NCT01432561|142886716|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||ANOVA|||High-protein compared to fasted condition||||.005
71876331|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.2|-0.3||||||Pruritus VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|
71684394|NCT01432561|142886717|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||High-fat/calorie compared to fasted condition||||.16
71684395|NCT01432561|142886717|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||ANOVA|||High-protein compared to fasted condition||||.036
71684396|NCT01432561|142886718|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Non-parametric Hodges-Lehmann method|||Fed high-fat/calorie compared to fasted condition.||||.30
71684397|NCT01432561|142886718|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Non-parametric Hodges-Lehmann method|||High-protein compared to fasted condition||||.05
71684398|NCT02952872|142886746|SUPERIORITY||||||<|0.05|||||||ANOVA|Mixed Design ANOVA||||||<.05
71684399|NCT02952872|142886747|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71684400|NCT02952872|142886748|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71684401|NCT02952872|142886749|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71684402|NCT02069093|142886752|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Incidence rate R|||A test of the incidence rate R was performed with null hypothesis H0: R\>= 0.33 and alternative hypothesis Ha: R\<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was \<0.33), the one-sided p-value for the null hypothesis R\>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was \<0.5.||||<0.001
71684403|NCT02028169|142886758|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684404|NCT02028169|142886759|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684405|NCT02028169|142886760|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline Vs. Month 9||||< 0.001
71684406|NCT02028169|142886761|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684407|NCT02028169|142886762|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71876332|NCT03627767|143271379|SUPERIORITY||LSM difference|0.0|||=|0.9294|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.2|= 0.9294
71684408|NCT02028169|142886762|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684409|NCT02028169|142886762|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684410|NCT02028169|142886765|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684411|NCT02028169|142886765|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684412|NCT02028169|142886765|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684413|NCT02028169|142886766|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684414|NCT02028169|142886766|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684415|NCT02028169|142886766|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684416|NCT02028169|142886767|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684417|NCT02028169|142886768|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684418|NCT02028169|142886768|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684419|NCT02028169|142886768|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684420|NCT02028169|142886770|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684421|NCT02028169|142886772|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684422|NCT02028169|142886772|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684423|NCT02028169|142886772|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684424|NCT02028169|142886773|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684425|NCT02028169|142886773|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684426|NCT02028169|142886773|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684427|NCT02028169|142886774|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684428|NCT02028169|142886774|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684429|NCT02028169|142886774|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684430|NCT02028169|142886775|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684431|NCT02028169|142886775|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684432|NCT02028169|142886775|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684433|NCT02028169|142886776|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3||||< 0.001
71684434|NCT02028169|142886776|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6||||< 0.001
71684435|NCT02028169|142886776|SUPERIORITY||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9||||< 0.001
71684436|NCT01969084|142886783|SUPERIORITY_OR_OTHER||||||>|0.05||||||A p-value of \< 0.05 was considered statistically significant|Wilcoxon (Mann-Whitney)|||Data were expressed as the median (25th:75th percentiles) for non-normally distributed data. The mean±sd for the groups was not analyzed as per the statistical plan.||||>0.05
71684437|NCT00862459|142886788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.59|STANDARD_DEVIATION|1.49||0.003|||||||t-test, 2 sided|||2 sample t-test between the dose groups||||0.003
71684438|NCT00862459|142886788|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|1.59||0.844|||||||t-test, 2 sided|||||||0.844
71684439|NCT00862459|142886789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.069|STANDARD_DEVIATION|2.92||||95.0|-0.825|0.69|||confidence interval using t-distribution|||||0.69|-0.825|
71684440|NCT00862459|142886789|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53|STANDARD_DEVIATION|3.18||||95.0|-0.9|0.79|||confidence interval using t-distribution|||||0.79|-0.90|
71684441|NCT00862459|142886790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|1.42||||95.0|-1.17|-0.42|||confidence interval using t-distribution|||||-0.42|-1.17|
71684442|NCT00862459|142886790|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|1.57||||95.0|-0.44|0.41|||confidence interval using t-distribution|||||0.41|-0.44|
71684443|NCT00862459|142886791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|0.86||||95.0|-0.619|-0.17|||confidence interval using t-distribution|||||-0.17|-0.619|
71684444|NCT00862459|142886791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|1.01||||95.0|-0.25|0.22|||confidence interval using t-distribution|||||0.22|-0.25|
71684445|NCT00862459|142886792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_DEVIATION|0.76||||95.0|-0.58|-0.18|||confidence interval using t-distribution|||||-0.18|-0.58|
71684446|NCT00862459|142886792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.76||||95.0|-0.1|0.31|||confidence interval using t-distribution|||||0.31|-0.10|
71684447|NCT00862459|142886793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.54|STANDARD_DEVIATION|76.45||||95.0|-37.11|2.02|||confidence interval using t-distribution|||difference in CNR between doses and confidence interval||2.02|-37.11|
71684448|NCT00862459|142886793|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74|STANDARD_DEVIATION|77.11||||95.0|-15.86|25.35|||confidence interval using t-distribution|||||25.35|-15.86|
71684449|NCT00862459|142886794|SUPERIORITY_OR_OTHER||accuracy difference|1.66|STANDARD_ERROR_OF_MEAN|6.29||0.8||95.0|-10.93|14.24|||Chi-squared|Adjusted for clustering||||14.24|-10.93|0.80
71684450|NCT00862459|142886794|SUPERIORITY_OR_OTHER||difference in accuracies|-10.75|STANDARD_ERROR_OF_MEAN|6.83||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
71684451|NCT00862459|142886795|SUPERIORITY_OR_OTHER||difference in accuracy|13.43||||0.03||95.0|1.53|25.33|||Chi-squared|adjusted for clustering||||25.33|1.53|0.03
71684452|NCT00862459|142886795|SUPERIORITY_OR_OTHER||difference in accuracies|-13.58||||0.02||95.0|-25.07|-2.09|||Chi-squared|adjusted for clustering||||-2.09|-25.07|0.02
71684453|NCT00862459|142886796|SUPERIORITY_OR_OTHER||difference in accuracy|-6.13||||0.11||95.0|-13.73|1.48|||Chi-squared|adjusted for clustering||||1.48|-13.73|0.11
71684454|NCT00862459|142886796|SUPERIORITY_OR_OTHER||difference in accuracies|2.87||||0.55||95.0|-6.59|12.32|||Chi-squared|adjusted for clustering||||12.32|-6.59|0.55
71684455|NCT00862459|142886797|SUPERIORITY_OR_OTHER||difference in accuracy|24.63||||0.02||95.0|5.39|43.86|||Chi-squared|adjusted for clustering||||43.86|5.39|0.02
71684456|NCT00862459|142886797|SUPERIORITY_OR_OTHER||difference in accuracy|-10.75||||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering||||2.90|-24.41|0.13
71684457|NCT00862459|142886798|SUPERIORITY_OR_OTHER||difference in accuracy|12.91||||0.07||95.0|-1.44|27.26|||Chi-squared|adjusted for clustering||||27.26|-1.44|0.07
71684458|NCT00862459|142886798|SUPERIORITY_OR_OTHER||difference in accuracy|-18.37||||0.02||95.0|-33.6|-1.35|||Chi-squared|adjusted for clustering||||-1.35|-33.60|0.02
71684459|NCT00862459|142886799|SUPERIORITY_OR_OTHER||difference in accuracy|18.46||||0.02||95.0|3.15|33.77|||Chi-squared|adjusted for clustering||||33.77|3.15|0.02
71684460|NCT00862459|142886799|SUPERIORITY_OR_OTHER||difference in accuracy|-5.29||||0.45||95.0|-18.83|8.24|||Chi-squared|adjusted for clustering||||8.24|-18.83|0.45
71684461|NCT04907227|142886853|OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.32|2.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.46|0.32|
71684462|NCT04907227|142886854|OTHER||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|0.68|3.67|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.67|0.68|
71684463|NCT04907227|142886855|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.45|1.5|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.50|0.45|
71684464|NCT04907227|142886857|OTHER||Percent Difference|4.3|||||TWO_SIDED|95.0|-24.1|31.2|||||Based on Miettinen \& Nurminen method.|||31.2|-24.1|
71684465|NCT04907227|142886859|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.17|1.99|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.99|0.17|
71684466|NCT04907227|142886860|OTHER||Hazard Ratio (HR)|1.64|||||TWO_SIDED|95.0|0.15|18.24|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||18.24|0.15|
71684467|NCT04907227|142886861|OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.41|1.46|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||1.46|0.41|
71684468|NCT04907227|142886862|OTHER||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.43|3.17|||||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.17|0.43|
71684469|NCT02240069|142886865|SUPERIORITY||Mean Difference (Net)|-0.11||||0.1|TWO_SIDED|95.0|-0.24|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Education group relative to Placebo group||0.02|-0.24|0.10
71684470|NCT02240069|142886865|SUPERIORITY||Mean Difference (Net)|0.01||||0.9|TWO_SIDED|95.0|-0.11|0.13|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1 for Filtration group relative to Placebo group||0.13|-0.11|0.90
71684471|NCT02240069|142886866|SUPERIORITY||Mean Difference (Net)|-0.09||||0.28|TWO_SIDED|95.0|-0.24|0.07|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Education group relative to Placebo group||0.07|-0.24|0.28
71684472|NCT02240069|142886866|SUPERIORITY||Mean Difference (Net)|0.01||||0.89|TWO_SIDED|95.0|-0.14|0.16|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FVC for Filter group relative to Placebo group||0.16|-0.14|0.89
71684473|NCT02240069|142886867|SUPERIORITY||Mean Difference (Net)|-0.02||||0.06|TWO_SIDED|95.0|-0.05|0.0|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Education group relative to Placebo group||0.00|-0.05|0.06
71684474|NCT02240069|142886867|SUPERIORITY||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in FEV1/FVC for Filter group relative to Placebo group||0.02|-0.03|0.71
71684475|NCT02240069|142886868|SUPERIORITY||Mean Difference (Net)|-3.46||||0.39|TWO_SIDED|95.0|-11.45|4.54|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Education group relative to Placebo group||4.54|-11.45|0.39
71684476|NCT02240069|142886868|SUPERIORITY||Mean Difference (Net)|0.25||||0.95|TWO_SIDED|95.0|-7.73|8.24|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in systolic blood pressure for Filter group relative to Placebo group||8.24|-7.73|0.95
71876333|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.1|||=|0.4081|TWO_SIDED|95.0|-0.3|0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|= 0.4081
71684477|NCT02240069|142886869|SUPERIORITY||Mean Difference (Net)|-1.0||||0.65|TWO_SIDED|95.0|-5.42|3.42|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Education group relative to Placebo group||3.42|-5.42|0.65
71684478|NCT02240069|142886869|SUPERIORITY||Mean Difference (Net)|-0.58||||0.79|TWO_SIDED|95.0|-4.97|3.81|||Mixed Models Analysis|Linear mixed models with a fixed term for mean pre-intervention response measure, and a nested random effect to account for repeated measures.||Pre- to post-intervention change in diastolic blood pressure for Filter group relative to Placebo group||3.81|-4.97|0.79
71684479|NCT02240069|142886870|SUPERIORITY||Mean Difference (Net)|-2.9||||0.88|TWO_SIDED|95.0|-33.6|42.0|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Education group relative to Placebo group||42.0|-33.6|0.88
71684480|NCT02240069|142886870|SUPERIORITY||Mean Difference (Net)|-50.5|||<|0.001|TWO_SIDED|95.0|-66.1|-27.8|||Mixed Models Analysis|Linear mixed models adjusted for pre-intervention PM2.5. The model includes a nested random term to account for repeated measures.||Pre- to post-intervention change in indoor PM2.5 concentration for Filter group relative to Placebo group||-27.8|-66.1|<0.001
71684481|NCT02134353|142886883|SUPERIORITY||Mean Difference (Net)|54.0||||0.02|TWO_SIDED|95.0|8.0|100.0|||Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF (baseline observation carried forward). Data collected at 6, 14 and 26 weeks.|||100|8|0.020
71684482|NCT02134353|142886884|SUPERIORITY||Mean Difference (Net)|40.0||||0.128|TWO_SIDED|95.0|-12.0|92.0||Missing data for withdrawals due to safety/efficacy imputed using BOCF. Data collected at 6,14 and 26 weeks.|Mixed Models Analysis||Missing data for withdrawals related to safety or efficacy imputed using BOCF. Data collected at 6, 14 and 26 weeks.|||92|-12|0.128
71684483|NCT02134353|142886885|SUPERIORITY||Cox Proportional Hazard|1.14||||0.629|TWO_SIDED|95.0|0.671|1.936|||Regression, Cox|||||1.936|0.671|0.629
71684484|NCT02134353|142886886|SUPERIORITY||Rate ratio|0.75||||0.673|TWO_SIDED|95.0|0.198|2.846|||Negative binomial model|||||2.846|0.198|0.673
71684485|NCT02134353|142886887|SUPERIORITY||Rate ratio|1.273||||0.735|TWO_SIDED|95.0|0.315|5.154|||Negative binomial model|||||5.154|0.315|0.735
71876334|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.3|0.1||||||Sleep Loss VAS: Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.3|
71876335|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.1|-1.4|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.1|< 0.0001
71684486|NCT02134353|142886888|SUPERIORITY||Rate ratio|1.545||||0.055|TWO_SIDED|95.0|0.99|2.411|||Negative binomial model|||Patients withdrawing early without an exacerbation had rate imputed based on number of exacerbations in 12 months prior to screening.||2.411|0.990|0.055
71684487|NCT02134353|142886888|SUPERIORITY||Rate ratio|1.357||||0.246|TWO_SIDED|95.0|0.81|2.275|||Negative binomial model|||Sensitivity analysis with no imputation of missing data.||2.275|0.810|0.246
71684488|NCT02134353|142886889|SUPERIORITY||Odds Ratio (OR)|1.009||||0.976|TWO_SIDED|95.0|0.555|1.836|||Regression, Logistic|||||1.836|0.555|0.976
71684489|NCT02134353|142886890|SUPERIORITY||Mean Difference (Net)|0.259||||0.083|TWO_SIDED|95.0|-0.034|0.551|||Mixed Models Analysis|Missing values due to withdrawal related to safety/efficacy imputed using BOCF||||0.551|-0.034|0.083
71684490|NCT02134353|142886891|SUPERIORITY||Mean Difference (Net)|0.87||||0.453|TWO_SIDED|95.0|-1.406|3.145|||Mixed Models Analysis||Missing values due to withdrawal related to safety/efficacy imputed using BOCF|||3.145|-1.406|0.453
71684491|NCT02134353|142886892|SUPERIORITY||Mean Difference (Net)|87.0||||0.012|TWO_SIDED|95.0|20.0|155.0|||Mixed Models Analysis||Missing data due to withdrawals for reasons related to safety/efficacy imputed using BOCF|||155|20|0.012
71684492|NCT00824434|142886894|SUPERIORITY_OR_OTHER||Mean In-stent Late Loss in WH Lesions|0.17|||<|0.0001|ONE_SIDED|95.0||0.22|||t-test, 1 sided|||The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)||0.22||<0.0001
71684493|NCT00824434|142886895|SUPERIORITY_OR_OTHER||Percent Post-procedure Incomplete Apposi|5.7|||<|0.0001|ONE_SIDED|95.0||11.6|||One-sided exact binomial test|||A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).||11.6||<0.0001
71684494|NCT00474786|142886909|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1933|TWO_SIDED|95.0|0.71|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.71|0.1933
71876336|NCT03627767|143271379|SUPERIORITY||LSM difference|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.7|-2.0|||Mixed Models Analysis|||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.0|-2.7|< 0.0001
71916898|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1248|STANDARD_ERROR_OF_MEAN|0.0188|<|0.0001|TWO_SIDED|95.0|0.0872|0.1625|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1||0.1625|0.0872|<0.0001
71684495|NCT00474786|142886910|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87||||0.1888|TWO_SIDED|95.0|0.7|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (\<) 1 means temsirolimus (TEMSR) is at lower risk.|||1.07|0.70|0.1888
71684496|NCT00474786|142886912|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.31||||0.0144|TWO_SIDED|95.0|1.05|1.63||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.|Log Rank||Hazard ratio \<1 means temsirolimus (TEMSR) is at lower risk.|||1.63|1.05|0.0144
71684497|NCT02436031|142886976|OTHER|||||||0.049|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit||||0.049
71684498|NCT02436031|142886976|OTHER|||||||0.135|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit||||0.135
71684499|NCT03403621|142887047|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.42
71684500|NCT03403621|142887047|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.72
71684501|NCT03403621|142887047|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.51
71684502|NCT03403621|142887047|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.58
71684503|NCT03403621|142887048|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.03
71684504|NCT03403621|142887048|SUPERIORITY|||||||0.08|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.08
71684505|NCT03403621|142887048|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.02
71684506|NCT03403621|142887048|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.007
71684507|NCT03403621|142887049|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.21
71684508|NCT03403621|142887049|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.18
71684509|NCT03403621|142887049|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Baseline versus 2 weeks||||0.33
71684510|NCT03403621|142887049|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||Baseline versus 4 weeks||||0.5
71876337|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-0.9|-0.2||||||Sleep Loss VAS: Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-0.9|
71876338|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.7|||=|0.0035|TWO_SIDED|95.0|-1.2|-0.2|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.2|= 0.0035
71876339|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.7|||Mixed Models Analysis|||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-1.6|< 0.0001
71876340|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.5|||||TWO_SIDED|95.0|-0.8|-0.1||||||Sleep Loss VAS: Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-0.8|
71684511|NCT01093651|142887051|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|Study subject was included in these models as a random variable to account for within-participant correlation.||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71916899|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1279|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.097|0.1587|||ANCOVA|standard error of the Mean difference|standard error of the Mean difference|AUC 0-12 on day 7||0.1587|0.0970|<0.0001
71916900|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1454|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.1151|0.1756|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1756|0.1151|<0.0001
71916901|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1699|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.2004|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2004|0.1393|<0.0001
71916902|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1814|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.1503|0.2125|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.2125|0.1503|<0.0001
71916903|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1697|STANDARD_ERROR_OF_MEAN|0.0152|<|0.0001|TWO_SIDED|95.0|0.1393|0.201|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.201|0.1393|<0.0001
71916904|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1384|STANDARD_ERROR_OF_MEAN|0.0216|<|0.0001|TWO_SIDED|95.0|0.0951|0.1817|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7||0.1817|0.0951|<0.0001
71916905|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0471|STANDARD_ERROR_OF_MEAN|0.0157|<|0.0001|TWO_SIDED|95.0|0.0155|0.0786|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.0786|0.0155|<0.0001
71758573|NCT04922216|143019380|SUPERIORITY||Mean Difference (Net)|0.24||||0.43|TWO_SIDED|95.0|-0.36|0.84|||Mixed Models Analysis|DF (2,622)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 1 (dietary self-monitoring) using linear mixed models comparing the effect of standard dietary monitoring to simplified dietary monitoring on weight change over time (from baseline to 3 months).||0.84|-0.36|0.43
71916906|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0918|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.0611|0.1226|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1226|0.0611|<0.0001
71916907|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0829|STANDARD_ERROR_OF_MEAN|0.0155|<|0.0001|TWO_SIDED|95.0|0.0519|0.1139|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1139|0.0519|<0.0001
71916908|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1299|STANDARD_ERROR_OF_MEAN|0.0158|<|0.0001|TWO_SIDED|95.0|0.0982|0.1617|||ANCOVA||standard error of the Mean difference|AUC 12-24 o day 1||0.1617|0.0982|<0.0001
71916909|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1369|STANDARD_ERROR_OF_MEAN|0.0154|<|0.0001|TWO_SIDED|95.0|0.1061|0.1678|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1678|0.1061|<0.0001
71916910|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0934|STANDARD_ERROR_OF_MEAN|0.0221|<|0.0001|TWO_SIDED|95.0|0.049|0.1377|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1||0.1377|0.0490|<0.0001
71916911|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0879|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.0573|0.1186|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1186|0.0573|<0.0001
71916912|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1088|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0788|0.1388|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1388|0.0788|<0.0001
71916913|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1175|STANDARD_ERROR_OF_MEAN|0.0151|<|0.0001|TWO_SIDED|95.0|0.0872|0.1478|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1478|0.0872|<0.0001
71916914|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1532|STANDARD_ERROR_OF_MEAN|0.0153|<|0.0001|TWO_SIDED|95.0|0.1226|0.1838|||ANCOVA||standard error of the Mean difference|||0.1838|0.1226|<0.0001
71916915|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.1048|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.0747|0.135|||ANCOVA||standard error of the Mean difference|||0.1350|0.0747|<0.0001
71916916|NCT01426009|143355422|SUPERIORITY||Least Squares Mean Difference (SE)|0.0993|STANDARD_ERROR_OF_MEAN|0.0202|<|0.0001|TWO_SIDED|95.0|0.0589|0.1398|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7||0.1398|0.0589|<0.0001
71916917|NCT01526928|143355506|OTHER||||||||||||||||||Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.|||
71916918|NCT01108068|143355521|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype T-test was used to compare differences at baseline between affecteds and unaffecteds||||||0.0003|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Cortical area Z-score||||0.0003
71916919|NCT01108068|143355521|EQUIVALENCE|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype||||||0.001|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Periosteal circumference Z-score||||0.001
71916920|NCT04716010|143355566|SUPERIORITY|||||||0.002||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.002
71916921|NCT04716010|143355566|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71916922|NCT04716010|143355566|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71916923|NCT04716010|143355566|SUPERIORITY|||||||0.024||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.024
71684512|NCT01093651|142887052|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71684513|NCT01093651|142887053|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71684514|NCT01093651|142887054|SUPERIORITY_OR_OTHER||||||<|0.0002||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p\<0.0002.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.0002
71684515|NCT01093651|142887055|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p\<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||>0.05
71684516|NCT01093651|142887056|SUPERIORITY_OR_OTHER||||||<|0.04||95.0||||The a priori threshold for statistical significance was p\<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p\<0.04.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.||||<0.04
71684517|NCT01093651|142887057|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||The a priori threshold for statistical significance was p\<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p\<0.05 (not statistically significant)|Kruskal-Wallis|||Kruskal-Wallis non-parametric test of cell frequencies||||>0.05
71684518|NCT03611582|142887059|SUPERIORITY||Treatment difference|-10.27|||<|0.0001|TWO_SIDED|95.0|-11.97|-8.57|||ANCOVA|||Treatment policy estimand||-8.57|-11.97|<.0001
71684519|NCT03611582|142887059|SUPERIORITY||Treatment difference|-12.67|||<|0.0001|TWO_SIDED|95.0|-14.34|-11.0|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||-11.00|-14.34|<0.0001
71684520|NCT03611582|142887060|SUPERIORITY||Odds Ratio (OR)|6.11|||<|0.0001|TWO_SIDED|95.0|4.04|9.26|||Regression, Logistic|||Treatment policy estimand||9.26|4.04|<0.0001
71684521|NCT03611582|142887060|SUPERIORITY||Odds Ratio (OR)|11.67|||<|0.0001|TWO_SIDED|95.0|7.64|17.81|||MMRM (mixed model repeated measurement)|||Hypothetical estimand||17.81|7.64|<0.0001
71684522|NCT04459598|142887090|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|55.24|||||TWO_SIDED|90.0|45.24|67.46|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||67.46|45.24|
71684523|NCT04459598|142887090|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|32.37|||||TWO_SIDED|90.0|23.79|44.05|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||44.05|23.79|
71684524|NCT04459598|142887092|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|11.11|||||TWO_SIDED|90.0|8.47|14.56|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||14.56|8.47|
71876341|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.7|||=|0.0136|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0136
71876342|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
71916924|NCT04716010|143355566|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71684525|NCT04459598|142887092|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.67|||||TWO_SIDED|90.0|2.47|5.45|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.45|2.47|
71684526|NCT04459598|142887093|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|10.29|||||TWO_SIDED|90.0|7.73|13.7|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for Quizartinib.||13.70|7.73|
71684527|NCT04459598|142887093|OTHER|Least squares (LS) means were calculated from an analysis of variance (ANOVA) model on log-transformed scale. The LS means for each treatment were back transformed from the log scale to provide estimates of the geometric means (GMS). The ratio (%) of GMS was calculated and 90% Confidence Intervals (CIs) for the ratio (%) of GMS were presented.|Ratio (%) of Geometric LS Mean|3.88|||||TWO_SIDED|90.0|2.62|5.76|||||For the comparison, the Efavirenz + Quizartinib treatment group represents the numerator and Quizartinib only treatment group represents the denominator.|Statistical comparison was analyzed for AC886.||5.76|2.62|
71684528|NCT01078298|142887099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.35|||<|0.0001|TWO_SIDED|95.0|2.16|5.21|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.21|2.16|<0.0001
71684529|NCT01078298|142887100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53||||0.0001|TWO_SIDED|95.0|1.56|4.1|||Regression, Logistic|||For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||4.10|1.56|0.0001
71684530|NCT01078298|142887100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36||||0.0011|TWO_SIDED|95.0|1.4|3.98|||Regression, Logistic|||For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.||3.98|1.40|0.0011
71876343|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.4|||||TWO_SIDED|95.0|-0.8|0.0||||||Sleep Loss VAS: Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-0.8|
71684531|NCT01078298|142887101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.82|||<|0.0001|TWO_SIDED|95.0|2.53|5.78|||Regression, Logistic|||For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||5.78|2.53|<0.0001
71684532|NCT01078298|142887101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.0004|TWO_SIDED|95.0|1.4|3.33|||Regression, Logistic|||For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.33|1.40|0.0004
71684533|NCT01078298|142887101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.98||||0.002|TWO_SIDED|95.0|1.28|3.08|||Regression, Logistic|||For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.28|0.0020
71684534|NCT01078298|142887102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0027|TWO_SIDED|95.0|1.26|3.08|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.||3.08|1.26|0.0027
71684535|NCT01653327|142887116|SUPERIORITY|||||||0.3198|||||||t-test, 2 sided|||||||0.3198
71684536|NCT01653327|142887117|SUPERIORITY|||||||0.3522|||||||t-test, 2 sided|||||||0.3522
71684537|NCT01738191|142887118|SUPERIORITY|||||||0.25||||||two sided|Global Statistical Test|df=28||The primary comparison between ATM and placebo used O'Brien's Global Statistical Test (GST) to analyze change from baseline to 10 weeks for the set of neuropsychological measures included in the primary efficacy outcome.||||0.25
71684538|NCT02243046|142887131|SUPERIORITY_OR_OTHER|||||||0.091|||||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.091
71684539|NCT02243046|142887132|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||<0.001
71684540|NCT02243046|142887133|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
71684541|NCT02243046|142887134|SUPERIORITY_OR_OTHER|||||||0.571|||||||ANOVA|||The null hypothesis states that there is no difference between groups||||0.571
71684542|NCT02243046|142887135|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
71684543|NCT02243046|142887136|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups||||< 0.001
71876344|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.3|||=|0.2887|TWO_SIDED|95.0|-1.0|0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.0|= 0.2887
71684544|NCT04607980|142887149|EQUIVALENCE|Clinical equivalence of the primary endpoint was evaluated by comparing the 2-sided 95% confidence interval (CI) of the mean difference of PASI percent improvement from Baseline to Week 12 between ABP 654 versus (vs) ustekinumab with an equivalence margin of (-15, +15).|Mean Difference (Final Values)|0.14|||||TWO_SIDED|95.0|-3.16|3.43||||||Multiple imputation was applied for the point estimate and CI of the mean difference between the 2 groups.||3.43|-3.16|
71876345|NCT03627767|143271379|SUPERIORITY||LSM difference|-1.0|||=|0.0025|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.6|= 0.0025
71684545|NCT04607980|142887150|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using analysis of covariance (ANCOVA) model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-2.05|5.94||||||"Week 4: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||5.94|-2.05|
71684546|NCT04607980|142887150|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-2.97|3.31||||||"Week 16: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||3.31|-2.97|
71684547|NCT04607980|142887150|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the initial randomized groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|-1.39|4.07||||||"Week 28: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||4.07|-1.39|
71684548|NCT04607980|142887150|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.26|||||TWO_SIDED|95.0|-5.46|7.98||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||7.98|-5.46|
71684549|NCT04607980|142887150|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-3.71|||||TWO_SIDED|95.0|-10.71|3.28||||||"Week 44: Treatment Group A vs Treatment Group B.~Observed data was used."||3.28|-10.71|
71684550|NCT04607980|142887150|EQUIVALENCE|The mean differences and 95% CIs of PASI percent improvement between the dose intensification groups (ABP 654 vs ustekinumab) at other scheduled visits was estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-8.45|7.13||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||7.13|-8.45|
71684551|NCT04607980|142887150|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-1.41|||||TWO_SIDED|95.0|-3.42|0.59||||||"Week 40: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.59|-3.42|
71876346|NCT03627767|143271379|SUPERIORITY||LSM difference|-0.6|||||TWO_SIDED|95.0|-1.0|-0.2||||||Sleep Loss VAS: Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.0|
71876347|NCT03627767|143271380|SUPERIORITY||Difference in percentage|1.0|||=|0.4244|TWO_SIDED|95.0|-1.4|3.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.4|-1.4|= 0.4244
71684552|NCT04607980|142887150|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.85|||||TWO_SIDED|95.0|-3.17|1.48||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.48|-3.17|
71916925|NCT04716010|143355566|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71684553|NCT04607980|142887150|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ABP 654/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.56|||||TWO_SIDED|95.0|-3.29|2.17||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||2.17|-3.29|
71876348|NCT03627767|143271380|SUPERIORITY||Difference in percentage|-0.3|||=|0.8092|TWO_SIDED|95.0|-3.1|2.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||2.4|-3.1|= 0.8092
71876349|NCT03627767|143271380|SUPERIORITY||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-4.1|1.0||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||1.0|-4.1|
71916926|NCT04716010|143355567|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.001
71916927|NCT04716010|143355567|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71916928|NCT04716010|143355567|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71916929|NCT04716010|143355567|SUPERIORITY|||||||0.022||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||0.022
71916930|NCT04716010|143355567|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71916931|NCT04716010|143355567|SUPERIORITY||||||<|0.001||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.001
71876350|NCT03627767|143271380|SUPERIORITY||Difference in percentage|46.7|||<|0.0001|TWO_SIDED|95.0|39.2|54.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||54.2|39.2|< 0.0001
71876351|NCT03627767|143271380|SUPERIORITY||Difference in percentage|63.6|||<|0.0001|TWO_SIDED|95.0|57.2|70.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||70.0|57.2|< 0.0001
71876352|NCT03627767|143271380|SUPERIORITY||Difference in percentage|17.0|||||TWO_SIDED|95.0|10.4|23.5||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.5|10.4|
71876353|NCT03627767|143271380|SUPERIORITY||Difference in percentage|41.3|||<|0.0001|TWO_SIDED|95.0|33.9|48.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||48.7|33.9|< 0.0001
71876354|NCT03627767|143271380|SUPERIORITY||Difference in percentage|59.9|||<|0.0001|TWO_SIDED|95.0|53.1|66.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||66.7|53.1|< 0.0001
71916932|NCT04716010|143355568|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \>0.05|Regression, Linear|||||||>0.05
71916933|NCT04716010|143355568|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916934|NCT04716010|143355568|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71876355|NCT03627767|143271380|SUPERIORITY||Difference in percentage|18.7|||||TWO_SIDED|95.0|10.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|10.8|
71876356|NCT03627767|143271380|SUPERIORITY||Difference in percentage|37.0|||<|0.0001|TWO_SIDED|95.0|29.6|44.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||44.4|29.6|< 0.0001
71876357|NCT03627767|143271380|SUPERIORITY||Difference in percentage|54.6|||<|0.0001|TWO_SIDED|95.0|47.6|61.7||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||61.7|47.6|< 0.0001
71876358|NCT03627767|143271380|SUPERIORITY||Difference in percentage|17.7|||||TWO_SIDED|95.0|9.4|26.0||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.0|9.4|
71916935|NCT04716010|143355568|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916936|NCT04716010|143355568|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916937|NCT04716010|143355568|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916938|NCT04716010|143355569|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916939|NCT04716010|143355569|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916940|NCT04716010|143355569|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916941|NCT04716010|143355569|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916942|NCT04716010|143355569|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916943|NCT04716010|143355569|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916944|NCT04716010|143355570|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916945|NCT04716010|143355570|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916946|NCT04716010|143355570|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916947|NCT04716010|143355570|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916948|NCT04716010|143355570|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916949|NCT04716010|143355570|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71876359|NCT03627767|143271380|SUPERIORITY||Difference in percentage|30.0|||<|0.0001|TWO_SIDED|95.0|22.6|37.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.4|22.6|< 0.0001
71876360|NCT03627767|143271380|SUPERIORITY||Difference in percentage|50.9|||<|0.0001|TWO_SIDED|95.0|43.8|58.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||58.1|43.8|< 0.0001
71876361|NCT03627767|143271380|SUPERIORITY||Difference in percentage|21.1|||||TWO_SIDED|95.0|12.8|29.5||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||29.5|12.8|
71876362|NCT03627767|143271381|SUPERIORITY||Difference in percentage|1.4|||=|0.7232|TWO_SIDED|95.0|-6.1|8.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||8.8|-6.1|= 0.7232
71876363|NCT03627767|143271381|SUPERIORITY||Difference in percentage|-2.2|||=|0.5694|TWO_SIDED|95.0|-9.8|5.4||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||5.4|-9.8|= 0.5694
71876364|NCT03627767|143271381|SUPERIORITY||Difference in percentage|-3.7|||||TWO_SIDED|95.0|-11.2|3.8||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.8|-11.2|
71876365|NCT03627767|143271381|SUPERIORITY||Difference in percentage|29.0|||<|0.0001|TWO_SIDED|95.0|22.2|35.8||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||35.8|22.2|< 0.0001
71876366|NCT03627767|143271381|SUPERIORITY||Difference in percentage|57.9|||<|0.0001|TWO_SIDED|95.0|51.2|64.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||64.5|51.2|< 0.0001
71916950|NCT04716010|143355571|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916951|NCT04716010|143355571|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916952|NCT04716010|143355571|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916953|NCT04716010|143355571|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916954|NCT04716010|143355571|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916955|NCT04716010|143355571|SUPERIORITY||||||<|0.05|||||||Regression, Linear|||||||<0.05
71916956|NCT04716010|143355572|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916957|NCT04716010|143355572|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916958|NCT04716010|143355572|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916959|NCT04716010|143355572|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916960|NCT04716010|143355572|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916961|NCT04716010|143355572|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916962|NCT04716010|143355573|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916963|NCT04716010|143355573|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916964|NCT04716010|143355573|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916965|NCT04716010|143355573|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916966|NCT04716010|143355573|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916967|NCT04716010|143355573|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916968|NCT04716010|143355574|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916969|NCT04716010|143355574|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916970|NCT04716010|143355574|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916971|NCT04716010|143355574|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916972|NCT04716010|143355574|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916973|NCT04716010|143355574|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71684554|NCT04607980|142887150|EQUIVALENCE|The differences for the mean percent change from baseline and the corresponding CIs were for ustekinumab/ABP 654 minus ustekinumab/ustekinumab. Estimated using ANCOVA model adjusted for baseline PASI value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.46|3.86||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||3.86|-2.46|
71876367|NCT03627767|143271381|SUPERIORITY||Difference in percentage|28.9|||||TWO_SIDED|95.0|20.8|37.0||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.0|20.8|
71916974|NCT04716010|143355575|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916975|NCT04716010|143355575|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916976|NCT04716010|143355575|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916977|NCT04716010|143355575|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71684555|NCT04607980|142887151|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.2|||||TWO_SIDED|95.0|-4.02|6.42||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||6.42|-4.02|
71876368|NCT03627767|143271381|SUPERIORITY||Difference in percentage|30.5|||<|0.0001|TWO_SIDED|95.0|23.9|37.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||37.2|23.9|< 0.0001
71876369|NCT03627767|143271381|SUPERIORITY||Difference in percentage|48.9|||<|0.0001|TWO_SIDED|95.0|42.1|55.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||55.6|42.1|< 0.0001
71876370|NCT03627767|143271381|SUPERIORITY||Difference in percentage|18.2|||||TWO_SIDED|95.0|9.8|26.6||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||26.6|9.8|
71876371|NCT03627767|143271381|SUPERIORITY||Difference in percentage|25.0|||<|0.0001|TWO_SIDED|95.0|18.4|31.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.5|18.4|< 0.0001
71916978|NCT04716010|143355575|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916979|NCT04716010|143355575|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916980|NCT04716010|143355576|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916981|NCT04716010|143355576|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916982|NCT04716010|143355576|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916983|NCT04716010|143355576|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916984|NCT04716010|143355576|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916985|NCT04716010|143355576|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916986|NCT04716010|143355577|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916987|NCT04716010|143355577|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916988|NCT04716010|143355577|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916989|NCT04716010|143355577|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916990|NCT04716010|143355577|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916991|NCT04716010|143355577|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916992|NCT04716010|143355578|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916993|NCT04716010|143355578|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916994|NCT04716010|143355578|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916995|NCT04716010|143355578|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916996|NCT04716010|143355578|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916997|NCT04716010|143355578|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71916998|NCT04716010|143355579|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71916999|NCT04716010|143355579|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917000|NCT04716010|143355579|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917001|NCT04716010|143355579|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917002|NCT04716010|143355579|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917003|NCT04716010|143355579|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917004|NCT04716010|143355580|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917005|NCT04716010|143355580|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917006|NCT04716010|143355580|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917007|NCT04716010|143355580|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917008|NCT04716010|143355580|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917009|NCT04716010|143355580|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917010|NCT04716010|143355581|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917011|NCT04716010|143355581|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917012|NCT04716010|143355581|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917013|NCT04716010|143355581|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917014|NCT04716010|143355581|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917015|NCT04716010|143355581|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917016|NCT04716010|143355582|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917017|NCT04716010|143355582|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917018|NCT04716010|143355582|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917019|NCT04716010|143355582|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917020|NCT04716010|143355582|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917021|NCT04716010|143355582|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917022|NCT04716010|143355583|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917023|NCT04716010|143355583|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917024|NCT04716010|143355583|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917025|NCT04716010|143355583|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917026|NCT04716010|143355583|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917027|NCT04716010|143355583|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917028|NCT04716010|143355584|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917029|NCT04716010|143355584|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917030|NCT04716010|143355584|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917031|NCT04716010|143355584|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917032|NCT04716010|143355584|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917033|NCT04716010|143355584|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917034|NCT04716010|143355585|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917035|NCT04716010|143355585|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917036|NCT04716010|143355585|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917037|NCT04716010|143355585|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917038|NCT04716010|143355585|SUPERIORITY||||||>|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||>0.05
71917039|NCT04716010|143355585|SUPERIORITY||||||<|0.05||||||The a priori threshold for statistical significance is \<0.05.|Regression, Linear|||||||<0.05
71917040|NCT00679380|143355588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|3.8||||0.2876|TWO_SIDED|95.0|-3.0|10.5|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Entocort EC and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Entocort EC versus budesonide MMX.||10.5|-3.0|0.2876
71917041|NCT00679380|143355588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|12.9||||0.0047|TWO_SIDED|95.0|4.6|21.3|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||21.3|4.6|0.0047
71917042|NCT00679380|143355588|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.1||||0.0481|TWO_SIDED|95.0|0.4|15.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||15.9|0.4|0.0481
71876372|NCT03627767|143271381|SUPERIORITY||Difference in percentage|39.6|||<|0.0001|TWO_SIDED|95.0|32.7|46.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||46.5|32.7|< 0.0001
71917043|NCT00679380|143355589|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-8.0||||0.2174|TWO_SIDED|95.0|-20.8||||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.||4.|-20.8|0.2174
71917044|NCT00679380|143355589|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|8.5||||0.2215|TWO_SIDED|95.0|-5.0|22.0|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||22.0|-5.0|0.2215
71917045|NCT00679380|143355589|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|-0.7||||0.9185|TWO_SIDED|95.0|-14.1|12.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).||12.7|-14.1|0.9185
71917046|NCT00679380|143355590|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions|5.4||||0.4293|TWO_SIDED|95.0|-8.0|18.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Entocort EC and placebo groups is shown here.||18.8|-8.0|0.4293
71917047|NCT02735044|143355672|NON_INFERIORITY|Non-inferiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference in the mean change in HbA1c from baseline to month 6 was \<0.3%.|LS Mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.172|0.179||||||Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||0.179|-0.172|
71876373|NCT03627767|143271381|SUPERIORITY||Difference in percentage|14.5|||||TWO_SIDED|95.0|6.3|22.8||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.8|6.3|
71917048|NCT02735044|143355672|SUPERIORITY|Superiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% CI for the difference between treatment groups was \<0 (zero).||||||0.965||||||Threshold for significance at 0.025 level.|ANCOVA|||A step-wise closed testing approach was used to control the type I error. Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (\<12 years and \>=12 years), and the continuous fixed covariates of the baseline HbA1c value.||||0.965
71917049|NCT01868594|143355687|SUPERIORITY|||||||0.019||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.019
71684556|NCT04607980|142887151|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.32|||||TWO_SIDED|95.0|-7.87|7.23||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||7.23|-7.87|
71684557|NCT04607980|142887151|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.82|||||TWO_SIDED|95.0|-5.75|7.37||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||7.37|-5.75|
71684558|NCT04607980|142887151|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.75|||||TWO_SIDED|95.0|-2.37|9.84||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||9.84|-2.37|
71684559|NCT04607980|142887151|EQUIVALENCE|Response difference in dose intensification participants (ABP 654 - ustekinumab) was estimated by the generalized linear model adjusted for the baseline PASI and the stratification factors with an identity link was used to obtain the point estimate and 95% CI for the risk difference of PASI 75 response rate at each scheduled timepoint.|Response difference|-3.19|||||TWO_SIDED|95.0|-28.15|21.76||||||"Week 36: Treatment Group A vs Treatment Group B.~Observed data was used."||21.76|-28.15|
71684560|NCT04607980|142887151|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.1|||||TWO_SIDED|95.0|-3.74|7.54||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||7.54|-3.74|
71684561|NCT04607980|142887151|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.85|||||TWO_SIDED|95.0|-4.89|8.39||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||8.39|-4.89|
71684562|NCT04607980|142887151|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.75|||||TWO_SIDED|95.0|-8.61|4.41||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||4.41|-8.61|
71684563|NCT04607980|142887151|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|0.14|||||TWO_SIDED|95.0|-7.32|7.43||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.43|-7.32|
71684564|NCT04607980|142887152|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-0.34|||||TWO_SIDED|95.0|-3.16|3.21||||||"Week 4: Treatment Group A vs Treatment Group B.~NRI was used."||3.21|-3.16|
71684565|NCT04607980|142887152|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|1.58|||||TWO_SIDED|95.0|-5.03|8.18||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||8.18|-5.03|
71684566|NCT04607980|142887152|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.81|||||TWO_SIDED|95.0|-3.62|11.17||||||"Week 16: Treatment Group A vs Treatment Group B.~NRI was used."||11.17|-3.62|
71876374|NCT03627767|143271381|SUPERIORITY||Difference in percentage|24.7|||<|0.0001|TWO_SIDED|95.0|18.1|31.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.2|18.1|< 0.0001
71876375|NCT03627767|143271381|SUPERIORITY||Difference in percentage|38.5|||<|0.0001|TWO_SIDED|95.0|31.6|45.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||45.3|31.6|< 0.0001
71876376|NCT03627767|143271381|SUPERIORITY||Difference in percentage|13.9|||||TWO_SIDED|95.0|5.6|22.3||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||22.3|5.6|
71876377|NCT03627767|143271389|SUPERIORITY||Difference in percentage|3.0|||=|0.4815|TWO_SIDED|95.0|-5.3|11.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||11.3|-5.3|= 0.4815
71917050|NCT01868594|143355688|SUPERIORITY|||||||0.0432||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0432
71917051|NCT01868594|143355689|SUPERIORITY|||||||0.7344||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.7344
71917052|NCT01868594|143355690|SUPERIORITY|||||||0.278||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.2780
71917053|NCT01868594|143355690|SUPERIORITY|||||||0.8114||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.8114
71917054|NCT01868594|143355690|SUPERIORITY|||||||0.1619||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.1619
71917055|NCT01868594|143355690|SUPERIORITY|||||||0.0764||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.0764
71917056|NCT01868594|143355691|SUPERIORITY|||||||0.3107||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3107
71917057|NCT01868594|143355691|SUPERIORITY|||||||0.5236||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.5236
71684567|NCT04607980|142887152|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|3.07|||||TWO_SIDED|95.0|-4.68|10.78||||||"Week 28: Treatment Group A vs Treatment Group B.~NRI was used."||10.78|-4.68|
71684568|NCT04607980|142887152|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-1.93|||||TWO_SIDED|95.0|-12.85|8.89||||||"Week 40: ABP 654 vs Ustekinumab.~NRI was used."||8.89|-12.85|
71917058|NCT01868594|143355691|SUPERIORITY|||||||0.3847||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.||||0.3847
71917059|NCT01868594|143355692|SUPERIORITY|||||||0.6716|||||||t-test, 2 sided|||||||0.6716
71917060|NCT01868594|143355693|SUPERIORITY|||||||0.2484||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.||||0.2484
71917061|NCT01868594|143355693|SUPERIORITY|||||||0.761||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hyperglycaemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.7610
71917062|NCT01868594|143355693|SUPERIORITY|||||||0.3714||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hypoglycemia question at Week 36 endpoint between Subetta and Placebo treatment groups."||||0.3714
71917063|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of vertical bowl transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||<|0.001||||||Comparing the change in performing a vertical bowl transfer, the calculated p-value for this activity was \<.001|t-test, 2 sided|||mRehab task vertical bowl transfer- moving the bowl vertically up and down||||<0.001
71917064|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of moving the bowl horizontally at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.001||||||Comparing the change in performing a horizontal bowl transfer, the calculated p-value for this activity was .001|t-test, 2 sided|||mRehab task horizontal bowl transfer- moving the bowl horizontally||||=.001
71917065|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of the vertical mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.003||||||Comparing the change in performing a vertical mug transfer, the calculated p-value for this activity was .003|t-test, 2 sided|||mRehab task vertical mug transfer- moving the mug vertically up and down||||=.003
71917066|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of the horizontal mug transfer at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.009||||||Comparing the change in performing a horizontal mug transfer, the calculated p-value for this activity was .009|t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.009
71917067|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of the simulated sip at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.933|||||||t-test, 2 sided|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||mRehab task simulate sip- bring mug within one inch of mouth as if taking a drink||||=.933
71917068|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of entering a phone number at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.136|||||||t-test, 2 sided|||mRehab task enter phone number||||=.136
71917069|NCT04363944|143355737|EQUIVALENCE|A paired-t test comparing performance of the quick tap at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.005|||||||t-test, 2 sided|||mRehab task quick tap- tapping a moving object on the phone screen||||=.005
71917070|NCT04363944|143355738|EQUIVALENCE|Paired t-tests comparing performance at the first session of in-home training to the last session of in-home training were conducted.|||||=|0.228|||||||t-test, 2 sided|||mRehab task vertical bowl transfer- moving bowl vertically up and down||||=.228
71917071|NCT04363944|143355738|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.||||||0.196|||||||t-test, 2 sided|||mRehab task horizontal bowl- bowl moved horizontally||||.196
71917072|NCT04363944|143355738|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.024|||||||t-test, 2 sided|||mRehab task Vertical Mug- Mug moved vertically and then placed on counter||||=.024
71917073|NCT04363944|143355738|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.038|||||||t-test, 2 sided|||mRehab task horizontal mug transfer- moving the mug horizontally||||=.038
71917074|NCT04363944|143355738|EQUIVALENCE|A paired-t test comparing performance at the beginning of the 6 week in-home program to the end of the 6 week in-home program.|||||=|0.306||||||calculated p-value greater than .05|t-test, 2 sided|||mRehab task simulate sip||||=.306
71917075|NCT04363944|143355739|EQUIVALENCE|The average of the WMFT from testing sessions pre intervention (week 1 and approximately week 2) was compared to the WMFT immediately following mRehab home intervention (week 8) using a two tailed paired t-test.|||||=|0.017||||||calculated p-value .017|t-test, 2 sided|||||||=.017
71917076|NCT04363944|143355740|EQUIVALENCE|Test, the scores from the first and second in-laboratory visits were averaged to account for variability in the performance of individuals with stroke. This averaged preintervention score was compared with the third in-laboratory visit to assess the immediate change in performance following use of mRehab.|||||=|0.019|||||||t-test, 2 sided|||Compared pre and post intervention data for participants using mRehab for a 6 week home program.||||=.019
71917077|NCT03057106|143355760|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.46|TWO_SIDED|90.0|0.67|1.16||2-sided, adjusted for stratification factors at rtandomization.|Log Rank|||||1.16|0.67|0.46
71917078|NCT03057106|143355761|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.0035|TWO_SIDED|95.0|0.52|0.88||2-sided, adjusted for stratification factors at randomization.|Log Rank|Adjusted for stratification factors at randomization.||||0.88|0.52|0.0035
71917079|NCT03057106|143355762|SUPERIORITY||Odds Ratio (OR)|1.69||||0.033|TWO_SIDED|95.0|1.04|2.76||2-sided, adjusted for stratification factors at randomization.|Cochran-Mantel-Haenszel|||||2.76|1.04|0.033
71917080|NCT03991936|143355764|SUPERIORITY||Mean Difference (Net)|-2.635|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided|||The null hypothesis was that the change from baseline to 24 weeks in the Nail Psoriasis Severity Index (NAPSI) for the triamcinolone acetonide groups: 2.5 mg/mL, 5.0 mg/mL, 7.5 mg/mL, and 10 mg/mL would be no different than the change from baseline to 24 weeks for the placebo group.||||<0.001
71917081|NCT03258593|143355810|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|67.5||||0.202|TWO_SIDED|95.0|25.0|75.0||Unadjusted p-value|Wilcoxon Rank sum test|||||75|25|0.202
71917082|NCT03258593|143355810|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|114.0||||0.667|TWO_SIDED|95.0|67.9|160.3||Unadjusted p-value|Wilcoxon Rank sum test|||||160.3|67.9|0.667
71684569|NCT04607980|142887152|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-4.93|||||TWO_SIDED|95.0|-17.39|7.73||||||"Week 40: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||7.73|-17.39|
71917083|NCT03258593|143355810|OTHER|Location Tests (Wilcoxon Rank sum test)|Median Difference (Net)|44.1||||0.463|TWO_SIDED|95.0|25.0|75.0|||Wilcoxon Rank sum test|||||75|25|0.463
71917084|NCT03258593|143355812|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|-17.75||||0.863|TWO_SIDED|95.0|-211.6|170.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||170.3|-211.6|0.863
71917085|NCT03258593|143355812|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|114.1||||0.666|TWO_SIDED|95.0|67.9|160.3|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||160.3|67.9|0.666
71917086|NCT03258593|143355812|OTHER|Location test (Rank sum based i.e., Wilcoxon test)|Median Difference (Net)|21.3||||0.949|TWO_SIDED|95.0|-203.9|269.9|||Wilcoxon Rank sum test||Median change; Signed Rank (S/R) of post-treatment PDL-1 levels minus baseline.|||269.9|-203.9|0.949
71917087|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|4.34|||<|0.001|TWO_SIDED|95.0|1.7|38.0||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 3 weeks compared to their respective baseline values.||38.0|1.7|<0.001
71917088|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|3.29|||<|0.001|TWO_SIDED|95.0|1.5|11.25||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interferon Gamma (IFN-γ) at 5 weeks compared to their respective baseline values.||11.25|1.5|<0.001
71684570|NCT04607980|142887152|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-8.42|13.3||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||13.30|-8.42|
71917089|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.4|||<|0.05|TWO_SIDED|95.0|0.1|0.7||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α) at 3 weeks compared to their respective baseline values.||0.7|0.1|<0.05
71917090|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.24||||0.052|TWO_SIDED|95.0|-0.01|0.96||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Tumor Necrosis Factor Alpha (TNF-α ) at 5 weeks compared to their respective baseline values.||0.96|-0.01|0.052
71917091|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.39||||0.055|TWO_SIDED|95.0|-0.03|4.61||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 6 (IL-6) at 3 weeks as compared to their respective baseline values.||4.61|-0.03|0.055
71917092|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.54||||0.06|TWO_SIDED|95.0|-0.06|1.96|||Paired samples Wilcoxon rank sum test|Hochberg adjustment may be used.||Interleukin 6 (IL-6) at 5 weeks as compared to their respective baseline values.||1.96|-0.06|0.06
71917093|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.73||||0.42|TWO_SIDED|95.0|-1.63|1.62||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 3 weeks as compared to their respective baseline values.||1.62|-1.63|0.420
71917094|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|-0.39||||0.733|TWO_SIDED|95.0|-1.315|1.31||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 8 (IL-8) at 5 weeks as compared to their respective baseline values.||1.31|-1.315|0.733
71917095|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.12||||0.01|TWO_SIDED|95.0|0.04|0.21||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 3 weeks as compared to their respective baseline values.||0.21|0.04|0.010
71917096|NCT03258593|143355814|OTHER|Other: median difference|Median Difference (Net)|0.1||||0.014|TWO_SIDED|95.0|0.04|0.4||Hochberg adjustment may be used.|Paired samples Wilcoxon rank sum test|||Interleukin 10 (IL-10) at 5 weeks as compared to their respective baseline values.||0.40|0.04|0.014
71917097|NCT03258593|143355816|OTHER|One curve estimated in this cohort. Not compared to any other curves.|Kaplan-Meier product-limit|13.2|||||TWO_SIDED|97.5|2.5|97.5||Unadjusted p-value|Kaplan-Meier product-limit estimates|||Disease free survival time was evaluated with the product-limit estimator by Kaplan-Meier test.||97.5|2.5|
71917098|NCT05085275|143355876|NON_INFERIORITY|The study planned to enroll 400 patients (200 patients in each treatment arm) to achieve 90% power to detect a hazard ratio (HR) of 0.60 for the primary composite endpoint, with differences between treatment groups assessed using a 2-sided alpha of \<0.05|Hazard Ratio (HR)|0.73||||0.1602|TWO_SIDED|95.0|0.46|1.14|||Regression, Cox|||||1.14|0.46|.1602
71917099|NCT05085275|143355878|OTHER||Hazard Ratio (HR)|0.78|STANDARD_ERROR_OF_MEAN|0.2392||0.3|||||||Regression, Cox|||||||.30
71917100|NCT05085275|143355879|OTHER||Hazard Ratio (HR)|0.35|STANDARD_ERROR_OF_MEAN|0.8295||0.17|||||||Regression, Cox|||||||0.17
71917101|NCT01327573|143355891|SUPERIORITY_OR_OTHER|||||||0.09||||||"This p-value was for the overall slope difference between groups (i.e. the interaction between group and time).~Significance level was set at 0.1 a priori."|Mixed effects model analysis|||Analysis used eGFR, group, time, and group-by-time variables.||||0.09
71684571|NCT04607980|142887152|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-2.41|||||TWO_SIDED|95.0|-14.91|10.19||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~NRI was used."||10.19|-14.91|
71684572|NCT04607980|142887153|EQUIVALENCE|Response difference (ABP 654 - ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|2.55|||||TWO_SIDED|95.0|-5.65|10.71||||||"Week 12: Treatment Group A vs Treatment Group B.~NRI was used."||10.71|-5.65|
71917102|NCT03070119|143355904|SUPERIORITY||Least square (LS) geometric mean ratio|0.86|||||TWO_SIDED|95.0|0.69|1.08||||||Week 52 - The analysis was based on an analysis of covariance (ANCOVA) model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation (MI) including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.08|0.69|
71917103|NCT03070119|143355904|SUPERIORITY||LS geometric mean ratio|0.91|||=|0.3711|TWO_SIDED|95.0|0.75|1.11|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.11|0.75|=0.3711
71917104|NCT03070119|143355904|SUPERIORITY||LS geometric mean ratio|1.06|||=|0.6344|TWO_SIDED|95.0|0.84|1.34|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.34|0.84|=0.6344
71684573|NCT04607980|142887153|EQUIVALENCE|Response difference (ABP 654/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-6.57|||||TWO_SIDED|95.0|-15.41|3.29||||||"Week 52: ABP 654 vs Ustekinumab.~NRI was used."||3.29|-15.41|
71684574|NCT04607980|142887153|EQUIVALENCE|Response difference (ustekinumab/ABP 654 - ustekinumab/ustekinumab) was estimated by the Mantel-Haenszel estimate, and the 95% CIs were estimated by the stratified Newcombe confidence limits, adjusting for actual stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Response difference|-7.46|||||TWO_SIDED|95.0|-18.41|3.74||||||"Week 52: ABP 654/Ustekinumab vs Ustekinumab.~NRI was used."||3.74|-18.41|
71684575|NCT04607980|142887154|EQUIVALENCE|Mean difference estimated for treatment group A and treatment group B using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.47|||||TWO_SIDED|95.0|-1.15|2.1||||||"Week 12: Treatment Group A vs Treatment Group B.~LOCF imputation was used."||2.10|-1.15|
71684576|NCT04607980|142887154|EQUIVALENCE|Mean difference estimated in dose intensification participants (treatment group A and treatment group B) using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|1.39|||||TWO_SIDED|95.0|-0.9|3.67||||||"Week 52: Treatment Group A vs Treatment Group B.~Observed data was used."||3.67|-0.90|
71684577|NCT04607980|142887154|EQUIVALENCE|Mean difference estimated for ABP 654/ ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|-0.13|||||TWO_SIDED|95.0|-0.99|0.74||||||"Week 52: ABP 654 vs Ustekinumab.~LOCF imputation was used."||0.74|-0.99|
71684578|NCT04607980|142887154|EQUIVALENCE|Mean difference estimated for ustekinumab/ABP 654 and ustekinumab/ ustekinumab using ANCOVA model adjusted for baseline BSA value, and the stratification factors of prior biologic use for psoriasis, baseline BW group, and geographic region.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.9|1.1||||||"Week 52: Ustekinumab/ABP 654 vs Ustekinumab.~LOCF imputation was used."||1.10|-0.90|
71684579|NCT00727090|142887191|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence|||||<|0.05|||||||t-test, 2 sided|||Null Hypothesis: Change in serum sodium from baseline is not different between groups||||<0.05
71758574|NCT04922216|143019380|SUPERIORITY||Mean Difference (Net)|-0.42||||0.17|TWO_SIDED|95.0|-1.01|0.18|||Mixed Models Analysis|DF (2,622)|Weekly adaptive goals coded as 0 (reference) and daily adaptive goals coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 2 (adaptive activity goals) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||0.18|-1.01|0.17
71876378|NCT03627767|143271389|SUPERIORITY||Difference in percentage|-1.8|||=|0.6748|TWO_SIDED|95.0|-10.3|6.6||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 12: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||6.6|-10.3|= 0.6748
71876379|NCT03627767|143271389|SUPERIORITY||Difference in percentage|-5.1|||||TWO_SIDED|95.0|-13.4|3.2||||||Week 12: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||3.2|-13.4|
71876380|NCT03627767|143271389|SUPERIORITY||Difference in percentage|24.0|||<|0.0001|TWO_SIDED|95.0|17.8|30.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||30.3|17.8|< 0.0001
71876381|NCT03627767|143271389|SUPERIORITY||Difference in percentage|42.3|||<|0.0001|TWO_SIDED|95.0|35.6|49.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 16: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||49.0|35.6|< 0.0001
71876382|NCT03627767|143271389|SUPERIORITY||Difference in percentage|18.4|||||TWO_SIDED|95.0|10.2|26.6||||||Week 16: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions||26.6|10.2|
71876383|NCT03627767|143271389|SUPERIORITY||Difference in percentage|24.6|||<|0.0001|TWO_SIDED|95.0|18.2|31.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||31.0|18.2|< 0.0001
71876384|NCT03627767|143271389|SUPERIORITY||Difference in percentage|40.5|||<|0.0001|TWO_SIDED|95.0|33.7|47.3||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 28: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||47.3|33.7|< 0.0001
71917105|NCT03070119|143355905|SUPERIORITY||LS geometric mean ratio|0.8|||||TWO_SIDED|95.0|0.63|1.03||||||Week 52 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.03|0.63|
71876385|NCT03627767|143271389|SUPERIORITY||Difference in percentage|15.9|||||TWO_SIDED|95.0|7.6|24.1||||||Week 28: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||24.1|7.6|
71876386|NCT03627767|143271389|SUPERIORITY||Difference in percentage|18.8|||<|0.0001|TWO_SIDED|95.0|12.6|25.1||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.1|12.6|< 0.0001
71876387|NCT03627767|143271389|SUPERIORITY||Difference in percentage|34.5|||<|0.0001|TWO_SIDED|95.0|27.6|41.5||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 40: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||41.5|27.6|< 0.0001
71876388|NCT03627767|143271389|SUPERIORITY||Difference in percentage|15.6|||||TWO_SIDED|95.0|7.5|23.7||||||Week 40: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||23.7|7.5|
71876389|NCT03627767|143271389|SUPERIORITY||Difference in percentage|18.7|||<|0.0001|TWO_SIDED|95.0|12.4|25.0||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||25.0|12.4|< 0.0001
71876390|NCT03627767|143271389|SUPERIORITY||Difference in percentage|32.3|||<|0.0001|TWO_SIDED|95.0|25.4|39.2||P-value was adjusted by disease severity at baseline and randomization strata.|Cochran-Mantel-Haenszel|||Week 52: Difference in percentage (PF-04965842 - Placebo) and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||39.2|25.4|< 0.0001
71876391|NCT03627767|143271389|SUPERIORITY||Difference in percentage|13.7|||||TWO_SIDED|95.0|5.6|21.7||||||Week 52: Difference in percentage and CI for difference were calculated based on the weighted average of difference for each randomization stratum and disease severity at baseline using the normal approximation of binomial proportions.||21.7|5.6|
71876392|NCT03627767|143271390|SUPERIORITY||LSM difference|0.1|||=|0.7373|TWO_SIDED|95.0|-0.5|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.5|= 0.7373
71876393|NCT03627767|143271390|SUPERIORITY||LSM difference|-0.1|||=|0.8092|TWO_SIDED|95.0|-0.7|0.5|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.7|= 0.8092
71876394|NCT03627767|143271390|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.8|0.4||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.8|
71876395|NCT03627767|143271390|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-6.1|-4.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.0|-6.1|< 0.0001
71876396|NCT03627767|143271390|SUPERIORITY||LSM difference|-6.6|||<|0.0001|TWO_SIDED|95.0|-7.6|-5.5|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.5|-7.6|< 0.0001
71876397|NCT03627767|143271390|SUPERIORITY||LSM difference|-1.5|||||TWO_SIDED|95.0|-2.4|-0.6||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-2.4|
71876398|NCT03627767|143271390|SUPERIORITY||LSM difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.7|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.7|-5.3|< 0.0001
71876399|NCT03627767|143271390|SUPERIORITY||LSM difference|-5.2|||<|0.0001|TWO_SIDED|95.0|-6.4|-3.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.9|-6.4|< 0.0001
71684580|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.527||||0.0211|TWO_SIDED|95.0|0.306|0.908|||Regression, Logistic|||The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.908|0.306|0.0211
71876400|NCT03627767|143271390|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.1|-0.3||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.1|
71876401|NCT03627767|143271390|SUPERIORITY||LSM difference|-1.9|||=|0.015|TWO_SIDED|95.0|-3.5|-0.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.5|= 0.0150
71876402|NCT03627767|143271390|SUPERIORITY||LSM difference|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-4.7|< 0.0001
71876403|NCT03627767|143271390|SUPERIORITY||LSM difference|-1.3|||||TWO_SIDED|95.0|-2.3|-0.3||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-2.3|
71876404|NCT03627767|143271390|SUPERIORITY||LSM difference|-0.8|||=|0.3616|TWO_SIDED|95.0|-2.4|0.9|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-2.4|= 0.3616
71876405|NCT03627767|143271390|SUPERIORITY||LSM difference|-2.7|||=|0.0012|TWO_SIDED|95.0|-4.3|-1.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-4.3|= 0.0012
71876406|NCT03627767|143271390|SUPERIORITY||LSM difference|-1.9|||||TWO_SIDED|95.0|-3.0|-0.8||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.8|-3.0|
71917106|NCT03070119|143355905|SUPERIORITY||LS geometric mean ratio|0.83|||=|0.2306|TWO_SIDED|95.0|0.6|1.13|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.13|0.60|=0.2306
71917107|NCT03070119|143355905|SUPERIORITY||LS geometric mean ratio|0.92|||=|0.673|TWO_SIDED|95.0|0.61|1.38|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model with natural log transformed data. The model included covariates for the corresponding baseline value i.e. log value, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||1.38|0.61|=0.6730
71876407|NCT03627767|143271391|SUPERIORITY||LSM difference|0.6|||=|0.3339|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.8|-0.6|= 0.3339
71876408|NCT03627767|143271391|SUPERIORITY||LSM difference|0.5|||=|0.4653|TWO_SIDED|95.0|-0.8|1.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-0.8|= 0.4653
71876409|NCT03627767|143271391|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-1.3|1.1||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.1|-1.3|
71876410|NCT03627767|143271391|SUPERIORITY||LSM difference|-4.3|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.3|-6.2|< 0.0001
71876411|NCT03627767|143271391|SUPERIORITY||LSM difference|-6.2|||<|0.0001|TWO_SIDED|95.0|-8.2|-4.3|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-4.3|-8.2|< 0.0001
71876412|NCT03627767|143271391|SUPERIORITY||LSM difference|-2.0|||||TWO_SIDED|95.0|-3.6|-0.3||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-3.6|
71876413|NCT03627767|143271391|SUPERIORITY||LSM difference|0.1|||=|0.9083|TWO_SIDED|95.0|-1.8|2.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||2.1|-1.8|= 0.9083
71876414|NCT03627767|143271391|SUPERIORITY||LSM difference|-1.1|||=|0.2439|TWO_SIDED|95.0|-3.0|0.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|-3.0|= 0.2439
71876415|NCT03627767|143271391|SUPERIORITY||LSM difference|-1.2|||||TWO_SIDED|95.0|-2.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-2.6|
71876416|NCT03627767|143271391|SUPERIORITY||LSM difference|-0.3|||=|0.7405|TWO_SIDED|95.0|-2.4|1.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.7|-2.4|= 0.7405
71876417|NCT03627767|143271391|SUPERIORITY||LSM difference|-2.1|||=|0.041|TWO_SIDED|95.0|-4.1|-0.1|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-4.1|= 0.0410
71876418|NCT03627767|143271391|SUPERIORITY||LSM difference|-1.7|||||TWO_SIDED|95.0|-3.1|-0.4||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-3.1|
71876419|NCT03627767|143271391|SUPERIORITY||LSM difference|-1.0|||=|0.4026|TWO_SIDED|95.0|-3.5|1.4|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.4|-3.5|= 0.4026
71876420|NCT03627767|143271391|SUPERIORITY||LSM difference|-1.9|||=|0.0944|TWO_SIDED|95.0|-4.2|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-4.2|= 0.0944
71917108|NCT03070119|143355906|SUPERIORITY||Least square (LS) mean difference|3.6|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|95.0|0.5|6.7||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||6.7|0.5|
71876421|NCT03627767|143271391|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-2.5|0.7||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-2.5|
71876422|NCT03627767|143271392|SUPERIORITY||Hazard Ratio (HR)|0.27|||<|0.0001|TWO_SIDED|95.0|0.211|0.341||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate p-value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% confidence interval (CI).||0.341|0.211|< 0.0001
71876423|NCT03627767|143271392|SUPERIORITY||Hazard Ratio (HR)|0.1|||<|0.0001|TWO_SIDED|95.0|0.07|0.136||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.136|0.070|< 0.0001
71876424|NCT03627767|143271392|SUPERIORITY||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.255|0.516||A stratified log-rank test with age group and disease severity as stratification variables was performed to evaluate P value.|Log Rank|||A Cox regression model with treatment, age group and disease severity as stratification covariates was used to estimate the hazard ratio and the corresponding 95% CI.||0.516|0.255|< 0.0001
71876425|NCT03627767|143271393|SUPERIORITY||LSM difference|0.1|||=|0.7556|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7556
71876426|NCT03627767|143271393|SUPERIORITY||LSM difference|0.1|||=|0.7484|TWO_SIDED|95.0|-0.4|0.6|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.4|= 0.7484
71876427|NCT03627767|143271393|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.5|-0.5|
71876428|NCT03627767|143271393|SUPERIORITY||LSM difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.6|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.6|< 0.0001
71917109|NCT03070119|143355906|SUPERIORITY||LS mean difference|3.7|STANDARD_ERROR_OF_MEAN|2.28|=|0.1054|TWO_SIDED|95.0|-0.8|8.2|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.2|-0.8|=0.1054
71684581|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.065|1.092|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.092|1.065|<0.0001
71684582|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0053|TWO_SIDED|95.0|1.061|1.403|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.403|1.061|0.0053
71917110|NCT03070119|143355906|SUPERIORITY||LS mean difference|3.6|STANDARD_ERROR_OF_MEAN|2.46|=|0.1432|TWO_SIDED|95.0|-1.2|8.4|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline ALSFRS-R total score, and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||8.4|-1.2|=0.1432
71917111|NCT03070119|143355907|SUPERIORITY||LS mean difference|8.1|STANDARD_ERROR_OF_MEAN|3.99|||TWO_SIDED|95.0|0.3|15.9||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.9|0.3|
71917112|NCT03070119|143355907|SUPERIORITY||LS mean difference|9.3|STANDARD_ERROR_OF_MEAN|5.6|=|0.0963|TWO_SIDED|95.0|-1.7|20.4|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||20.4|-1.7|=0.0963
71917113|NCT03070119|143355907|SUPERIORITY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|5.56|=|0.4388|TWO_SIDED|95.0|-6.6|15.2|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline percent predicted SVC and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||15.2|-6.6|= 0.4388
71917114|NCT03070119|143355908|SUPERIORITY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.109|||TWO_SIDED|95.0|0.051|0.477||||||Week 52 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.477|0.051|
71917115|NCT03070119|143355908|SUPERIORITY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.145|=|0.3207|TWO_SIDED|95.0|-0.141|0.43|||ANCOVA|ANCOVA model using MI.||Week 104 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.430|-0.141|=0.3207
71917116|NCT03070119|143355908|SUPERIORITY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.091|=|0.5452|TWO_SIDED|95.0|-0.124|0.234|||ANCOVA|ANCOVA model using MI.||Week 148 - The analysis was based on an ANCOVA model that included treatment as a fixed effect and adjusted for the following covariates: baseline plasma NfL, baseline HHD overall megascore and use of riluzole or edaravone. Multiple imputation including treatment group, use of riluzole or edaravone, baseline NfL, and the relevant baseline and postbaseline values for the endpoint was used for missing data.||0.234|-0.124|=0.5452
71917117|NCT03070119|143355910|SUPERIORITY||Hazard Ratio (HR)|0.64|||=|0.4202|TWO_SIDED|95.0|0.282|1.461|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.461|0.282|=0.4202
71917118|NCT03070119|143355911|SUPERIORITY||Hazard Ratio (HR)|0.52|||=|0.3108|TWO_SIDED|95.0|0.199|1.357|||Log Rank|The analysis was based on a log rank test stratified by median baseline plasma NfL.|The analysis was based on a Cox proportional hazards model adjusted for baseline plasma NfL, and riluzole or edaravone use.|||1.357|0.199|=0.3108
71917119|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26|STANDARD_ERROR_OF_MEAN|2.777|||TWO_SIDED|95.0|-3.39|7.91|||||Day 1, Max HR|||7.91|-3.39|
71917120|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.922|||TWO_SIDED|95.0|-4.78|7.28|||||Day 7, Max HR|||7.28|-4.78|
71917121|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-2.37|8.91|||||Day 1, Max HR|||8.91|-2.37|
71917122|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|2.729|||TWO_SIDED|95.0|-7.89|3.39|||||Day 7, Max HR|||3.39|-7.89|
71917123|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.49|STANDARD_ERROR_OF_MEAN|2.899|||TWO_SIDED|95.0|1.59|13.39|||||Day 1, Max HR|||13.39|1.59|
71917124|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|3.079|||TWO_SIDED|95.0|2.34|15.05|||||Day 7, Max HR|||15.05|2.34|
71917125|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|2.243|||TWO_SIDED|95.0|-4.8|4.34|||||Day 1, WM|||4.34|-4.80|
71917126|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.52|||TWO_SIDED|95.0|-5.09|5.4|||||Day 7, WM|||5.40|-5.09|
71917127|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.33|STANDARD_ERROR_OF_MEAN|2.182|||TWO_SIDED|95.0|-2.12|6.77|||||Day 1, WM|||6.77|-2.12|
71917128|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.51|STANDARD_ERROR_OF_MEAN|2.378|||TWO_SIDED|95.0|-7.48|2.45|||||Day 7, WM|||2.45|-7.48|
71917129|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.16|STANDARD_ERROR_OF_MEAN|2.282|||TWO_SIDED|95.0|1.51|10.81|||||Day 1, WM|||10.81|1.51|
71917130|NCT00732472|143355915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.06|STANDARD_ERROR_OF_MEAN|2.642|||TWO_SIDED|95.0|1.57|12.54|||||Day 7, WM|||12.54|1.57|
71917131|NCT01266876|143355937|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~1. Alirocumab 150 mg Q2W versus placebo~2. Alirocumab 300 mg Q4W versus placebo~3. Alirocumab 200 mg Q4W versus placebo~4. Alirocumab 150 mg Q4W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."||||0.0000
71917132|NCT01266876|143355937|SUPERIORITY_OR_OTHER|||||||0|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0000
71917133|NCT01266876|143355937|SUPERIORITY_OR_OTHER|||||||0.0035|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0035
71917134|NCT01266876|143355937|SUPERIORITY_OR_OTHER|||||||0.0113|TWO_SIDED|||||Threshold for significance at ≤ 0.05.|ANCOVA|||||||0.0113
71917135|NCT01996865|143355968|OTHER||Hazard Ratio (HR)|0.8||||0.3296|TWO_SIDED|95.0|0.6|1.2|||Regression, Cox|||||1.2|0.6|0.3296
71917136|NCT01996865|143355969|OTHER||Hazard Ratio (HR)|0.7||||0.1222|TWO_SIDED|95.0|0.4|1.1|||Regression, Cox|||||1.1|0.4|0.1222
71684583|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.464||||0.0079|TWO_SIDED|95.0|0.264|0.818|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.818|0.264|0.0079
71684584|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.737||||0.1808|TWO_SIDED|95.0|0.471|1.153|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.153|0.471|0.1808
71917137|NCT03733132|143356022|SUPERIORITY|||||||0.854|||||||t-test, 2 sided|||||||0.854
71917138|NCT03733132|143356023|SUPERIORITY|||||||0.389|||||||t-test, 2 sided|||||||0.389
71917139|NCT03733132|143356024|SUPERIORITY|||||||0.609|||||||t-test, 2 sided|||||||0.609
71917140|NCT03733132|143356025|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
71917141|NCT03733132|143356026|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
71917142|NCT05492877|143356062|SUPERIORITY||Hazard Ratio (HR)|1.071||||0.599|TWO_SIDED|90.0|0.869|1.32|||Regression, Cox||||The p-value was based on a 2-sided log rank test stratified by region|1.320|0.869|0.599
71917143|NCT05492877|143356065|SUPERIORITY||Hazard Ratio (HR)|1.234|||||TWO_SIDED|90.0|0.882|1.726|||Regression, Cox|||||1.726|0.882|
71917144|NCT04476108|143356097|SUPERIORITY||Posterior Mean Difference|-0.42|||||TWO_SIDED|95.0|-1.17|0.32|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.32|-1.17|
71917145|NCT04476108|143356098|SUPERIORITY||Posterior Mean Difference|-0.37|||||TWO_SIDED|95.0|-1.09|0.35|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.35|-1.09|
71917146|NCT04476108|143356099|SUPERIORITY||Posterior Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.69|0.15|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.15|-0.69|
71917147|NCT04476108|143356100|SUPERIORITY||Posterior Mean Difference|-0.44|||||TWO_SIDED|95.0|-1.2|0.31|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.31|-1.20|
71917148|NCT04476108|143356101|SUPERIORITY||Posterior Mean Difference|-2.86|||||TWO_SIDED|95.0|-11.71|6.06|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||6.06|-11.71|
71917149|NCT04476108|143356102|SUPERIORITY||Posterior Mean Difference|0.35|||||TWO_SIDED|95.0|-0.09|0.78|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.78|-0.09|
71917150|NCT04476108|143356103|SUPERIORITY||Posterior Mean Difference|0.34|||||TWO_SIDED|95.0|-188.46|187.97|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||187.97|-188.46|
71917151|NCT04476108|143356104|SUPERIORITY||Posterior Mean Difference|0.04|||||TWO_SIDED|95.0|-0.01|0.1|||Bayesian Mixed Model Analysis||The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.|||0.10|-0.01|
71917152|NCT03299166|143356174|SUPERIORITY||LS Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.81||0.2202|TWO_SIDED|95.0|-2.59|0.6|||Mixed Models Analysis|||Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect.||0.60|-2.59|0.2202
71917153|NCT03299166|143356181|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.61||0.4508|TWO_SIDED|95.0|-1.67|0.75|||Mixed Models Analysis|||"Week 4 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||0.75|-1.67|0.4508
71917154|NCT03299166|143356181|SUPERIORITY||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|0.75||0.041|TWO_SIDED|95.0|-3.02|-0.06|||Mixed Models Analysis|||"Week 8 Analysis.~Model-based summary statistics are from a mixed model with repeated measures, including fixed effects for treatment, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction as covariates, and participant as random effect."||-0.06|-3.02|0.0410
71917155|NCT02875366|143356213|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.3021|TWO_SIDED|95.0|-9.2|2.9|||Mixed effects model for repeated measure|||||2.9|-9.2|0.3021
71684585|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.082|||<|0.0001|TWO_SIDED|95.0|1.069|1.095|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.095|1.069|<0.0001
71917156|NCT02875366|143356214|SUPERIORITY||Least Squares Mean Difference|-3.2||||0.1894|TWO_SIDED|95.0|-8.0|1.6|||Mixed effects model for repeated measure|||||1.6|-8.0|0.1894
71917157|NCT02875366|143356215|SUPERIORITY||Least Squares Mean Difference|-15.3||||0.2328|TWO_SIDED|95.0|-40.8|10.1|||Mixed effects model for repeated measure|||||10.1|-40.8|0.2328
71917158|NCT02875366|143356216|SUPERIORITY||Least Squares Mean Difference|-1.4||||0.1203|TWO_SIDED|95.0|-3.1|0.4|||Mixed effects model for repeated measure|||||0.4|-3.1|0.1203
71917159|NCT02875366|143356217|SUPERIORITY||Least Squares Mean Difference|-149.6||||0.0439|TWO_SIDED|95.0|-295.0|-4.2|||Mixed effects model for repeated measure|||||-4.2|-295.0|0.0439
71917160|NCT02875366|143356218|SUPERIORITY||Least Squares Mean Difference|-7.5||||0.2237|TWO_SIDED|95.0|-19.8|4.7|||Mixed effects model for repeated measure|||||4.7|-19.8|0.2237
71917161|NCT02875366|143356219|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.0226|TWO_SIDED|95.0|-1.12|-0.09|||Mixed effects model for repeated measure|||||-0.09|-1.12|0.0226
71917162|NCT02875366|143356220|SUPERIORITY||Least Squares Mean Difference|-6.32||||0.0613|TWO_SIDED|95.0|-12.94|0.31|||Mixed effects model for repeated measure|||||0.31|-12.94|0.0613
71917163|NCT02875366|143356221|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6409|TWO_SIDED|95.0|-0.9|1.5|||Mixed effects model for repeated measure|||||1.5|-0.9|0.6409
71917164|NCT02875366|143356222|SUPERIORITY||Least Squares Mean Difference|1.0||||0.5889|TWO_SIDED|95.0|-2.7|4.7|||Mixed effects model for repeated measure|||||4.7|-2.7|0.5889
71917165|NCT02875366|143356223|SUPERIORITY||Least Squares Mean Difference|3.4||||0.146|TWO_SIDED|95.0|-1.2|8.1|||Mixed effects model for repeated measure|||||8.1|-1.2|0.1460
71917166|NCT02875366|143356224|SUPERIORITY||Least Squares Mean Difference|3.5||||0.3091|TWO_SIDED|95.0|-3.4|10.4|||Mixed effects model for repeated measure|||||10.4|-3.4|0.3091
71917167|NCT02875366|143356225|SUPERIORITY||Least Squares Mean Difference|0.2||||0.3961|TWO_SIDED|95.0|-0.3|0.6|||Mixed effects model for repeated measure|||||0.6|-0.3|0.3961
71917168|NCT02875366|143356226|SUPERIORITY||Least Squares Mean Difference|0.9||||0.3905|TWO_SIDED|95.0|-1.2|3.1|||Mixed effects model for repeated measure|||||3.1|-1.2|0.3905
71917169|NCT02875366|143356227|SUPERIORITY||Least Squares Mean Difference|6.2||||0.1257|TWO_SIDED|95.0|-1.8|14.1|||Mixed effects model for repeated measure|||||14.1|-1.8|0.1257
71917170|NCT01682759|143356318|NON_INFERIORITY_OR_EQUIVALENCE|Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.|Difference in the least squares means|0.18|||||TWO_SIDED|95.0|0.06|0.3|||||Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||0.30|0.06|
71917171|NCT01682759|143356319|SUPERIORITY_OR_OTHER||Difference in percentages|-6.9|||||TWO_SIDED|95.0|-13.9|0.1|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||0.1|-13.9|
71917172|NCT01682759|143356320|SUPERIORITY_OR_OTHER||Difference in percentages|1.1|||||TWO_SIDED|95.0|-1.6|3.8|||||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||3.8|-1.6|
71917173|NCT01682759|143356321|SUPERIORITY_OR_OTHER||Difference in the least squares means|5.6|||||TWO_SIDED|95.0|0.1|11.2|||||cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups|||11.2|0.1|
71917174|NCT01682759|143356322|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|-3.7|||||TWO_SIDED|95.0|-10.6|3.3|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \<6.5%||3.3|-10.6|
71917175|NCT01682759|143356323|SUPERIORITY_OR_OTHER||Difference in percentages|-21.3|||<|0.001|TWO_SIDED|95.0|-26.5|-16.4|||Difference in percentages||Miettinen \& Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.|||-16.4|-26.5|<0.001
71917176|NCT01682759|143356324|SUPERIORITY_OR_OTHER||Difference in the least squares means|-1.9|||<|0.001|TWO_SIDED|95.0|-2.5|-1.4|||Difference in the least squares means||cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.|||-1.4|-2.5|<0.001
71917177|NCT01682759|143356325|SUPERIORITY_OR_OTHER||Between-group Rate Difference|-10.3|||||TWO_SIDED|95.0|-17.8|-2.8|||||Between-group CIs are calculated via Miettinen \& Nurminen method.|A1C \< 7.0%||-2.8|-17.8|
71917178|NCT02141854|143356326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.179||||0.0009|TWO_SIDED|95.0|0.074|0.285||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.||0.285|0.074|0.0009
71917179|NCT02141854|143356326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.182||||0.001|TWO_SIDED|95.0|0.074|0.291||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.||0.291|0.074|0.0010
71917180|NCT02141854|143356326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.326||||0|TWO_SIDED|95.0|0.221|0.431||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.||0.431|0.221|0.0000
71684586|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.676||||0.0005|TWO_SIDED|95.0|0.542|0.844|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.844|0.542|0.0005
71684587|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.573||||0.0041|TWO_SIDED|95.0|0.392|0.838|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.838|0.392|0.0041
71876429|NCT03627767|143271393|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.9|< 0.0001
71876430|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.7|
71876431|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.6|||=|0.0242|TWO_SIDED|95.0|-1.2|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.2|= 0.0242
71876432|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.9|||=|0.0012|TWO_SIDED|95.0|-1.4|-0.4|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-1.4|= 0.0012
71876433|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.6|0.1||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.6|
71876434|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.6|||=|0.124|TWO_SIDED|95.0|-1.3|0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-1.3|= 0.1240
71876435|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.9|||=|0.0107|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.6|= 0.0107
71876436|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.3|||||TWO_SIDED|95.0|-0.8|0.1||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-0.8|
71876437|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.4|||=|0.3139|TWO_SIDED|95.0|-1.1|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-1.1|= 0.3139
71917181|NCT02141854|143356326|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.322||||0|TWO_SIDED|95.0|0.212|0.432||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.||0.432|0.212|0.0000
71876438|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.6|||=|0.0853|TWO_SIDED|95.0|-1.3|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.3|= 0.0853
71876439|NCT03627767|143271393|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.7|0.2||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.7|
71876440|NCT03627767|143271394|SUPERIORITY||LSM difference|0.4|||=|0.0674|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.8|0.0|= 0.0674
71876441|NCT03627767|143271394|SUPERIORITY||LSM difference|0.3|||=|0.1437|TWO_SIDED|95.0|-0.1|0.7|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.1|= 0.1437
71876442|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.1|||||TWO_SIDED|95.0|-0.5|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.5|
71684588|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.094|||<|0.0001|TWO_SIDED|95.0|1.048|1.142|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.142|1.048|<0.0001
71684589|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.945||||0.0031|TWO_SIDED|95.0|2.013|31.359|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||31.359|2.013|0.0031
71684590|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.0012|TWO_SIDED|95.0|0.844|0.959|||Regression, Logistic|||The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m\^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.959|0.844|0.0012
71684591|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.619||||0.0085|TWO_SIDED|95.0|0.433|0.885|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.885|0.433|0.0085
71917182|NCT02141854|143356327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.276||||0|TWO_SIDED|95.0|0.191|0.361||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.||0.361|0.191|0.0000
71917183|NCT02141854|143356327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.274||||0|TWO_SIDED|95.0|0.189|0.36||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.||0.360|0.189|0.0000
71917184|NCT02141854|143356327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.183||||0|TWO_SIDED|95.0|0.098|0.268||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.||0.268|0.098|0.0000
71917185|NCT02141854|143356327|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.123||||0.0047|TWO_SIDED|95.0|0.038|0.208||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.||0.208|0.038|0.0047
71917186|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|18.45||||0|TWO_SIDED|95.0|11.751|25.15||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||25.150|11.751|0.0000
71917187|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|16.718||||0|TWO_SIDED|95.0|9.988|23.449||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||23.449|9.988|0.0000
71917188|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|31.221||||0|TWO_SIDED|95.0|24.513|37.93||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||37.930|24.513|0.0000
71917189|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|29.597||||0|TWO_SIDED|95.0|22.839|36.354||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||36.354|22.839|0.0000
71917190|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.771||||0.0002|TWO_SIDED|95.0|6.179|19.363||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.363|6.179|0.0002
71684592|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||<|0.0001|TWO_SIDED|95.0|1.087|1.174|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.174|1.087|<0.0001
71876443|NCT03627767|143271394|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
71876444|NCT03627767|143271394|SUPERIORITY||LSM difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.8|-0.9|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-1.8|< 0.0001
71876445|NCT03627767|143271394|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.4|0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-0.4|
71876446|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.4|||=|0.1136|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.0|= 0.1136
71876447|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.6|||=|0.0276|TWO_SIDED|95.0|-1.1|-0.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.1|-1.1|= 0.0276
71876448|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.2|||||TWO_SIDED|95.0|-0.5|0.2||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.5|
71876449|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.9|||=|0.0108|TWO_SIDED|95.0|-1.5|-0.2|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-1.5|= 0.0108
71876450|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.6|||=|0.0677|TWO_SIDED|95.0|-1.3|0.0|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.0|-1.3|= 0.0677
71876451|NCT03627767|143271394|SUPERIORITY||LSM difference|0.3|||||TWO_SIDED|95.0|-0.2|0.7||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.7|-0.2|
71876452|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.5|||=|0.132|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.1|-1.1|= 0.1320
71684593|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.784||||0.0341|TWO_SIDED|95.0|0.626|0.982|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.982|0.626|0.0341
71684594|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.575||||0.0443|TWO_SIDED|95.0|0.335|0.986|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (\> 1.5 vs \<=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.986|0.335|0.0443
71684595|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1|||<|0.0001|TWO_SIDED|95.0|1.057|1.144|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.144|1.057|<0.0001
71684596|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|22.867||||0.0039|TWO_SIDED|95.0|2.73|191.56|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||191.56|2.730|0.0039
71876453|NCT03627767|143271394|SUPERIORITY||LSM difference|-0.3|||=|0.2975|TWO_SIDED|95.0|-0.9|0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.9|= 0.2975
71876454|NCT03627767|143271394|SUPERIORITY||LSM difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.6|-0.2|
71876455|NCT03627767|143271395|SUPERIORITY||LSM difference|-0.4|||=|0.3531|TWO_SIDED|95.0|-1.3|0.4|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.4|-1.3|= 0.3531
71876456|NCT03627767|143271395|SUPERIORITY||LSM difference|0.0|||=|0.9282|TWO_SIDED|95.0|-0.8|0.9|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.9|-0.8|= 0.9282
71876457|NCT03627767|143271395|SUPERIORITY||LSM difference|0.4|||||TWO_SIDED|95.0|-0.4|1.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||1.3|-0.4|
71876458|NCT03627767|143271395|SUPERIORITY||LSM difference|-6.1|||<|0.0001|TWO_SIDED|95.0|-7.3|-5.0|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.0|-7.3|< 0.0001
71876459|NCT03627767|143271395|SUPERIORITY||LSM difference|-9.2|||<|0.0001|TWO_SIDED|95.0|-10.3|-8.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-8.1|-10.3|< 0.0001
71684597|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.0244|TWO_SIDED|95.0|0.628|0.968|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||0.968|0.628|0.0244
71684598|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.128|||<|0.0001|TWO_SIDED|95.0|1.086|1.172|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.172|1.086|<0.0001
71917191|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|12.879||||0.0002|TWO_SIDED|95.0|6.216|19.541||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||19.541|6.216|0.0002
71917192|NCT02141854|143356328|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|11.146||||0.001|TWO_SIDED|95.0|4.511|17.782||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||17.782|4.511|0.0010
71917193|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.156||||0.001|TWO_SIDED|95.0|-0.248|-0.063||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.063|-0.248|0.0010
71917194|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.195||||0|TWO_SIDED|95.0|-0.288|-0.102||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.102|-0.288|0.0000
71917195|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.304||||0|TWO_SIDED|95.0|-0.397|-0.212||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.212|-0.397|0.0000
71917196|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.277||||0|TWO_SIDED|95.0|-0.37|-0.184||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.184|-0.370|0.0000
71917197|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.149||||0.0014|TWO_SIDED|95.0|-0.239|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.058|-0.239|0.0014
71917198|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.082||||0.0818|TWO_SIDED|95.0|-0.174|0.01||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.010|-0.174|0.0818
71876460|NCT03627767|143271395|SUPERIORITY||LSM difference|-3.1|||||TWO_SIDED|95.0|-4.0|-2.1||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.1|-4.0|
71876461|NCT03627767|143271395|SUPERIORITY||LSM difference|-4.6|||<|0.0001|TWO_SIDED|95.0|-6.2|-2.9|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-2.9|-6.2|< 0.0001
71876462|NCT03627767|143271395|SUPERIORITY||LSM difference|-6.7|||<|0.0001|TWO_SIDED|95.0|-8.3|-5.1|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-5.1|-8.3|< 0.0001
71876463|NCT03627767|143271395|SUPERIORITY||LSM difference|-2.1|||||TWO_SIDED|95.0|-3.3|-0.9||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.9|-3.3|
71876464|NCT03627767|143271395|SUPERIORITY||LSM difference|-2.6|||=|0.0082|TWO_SIDED|95.0|-4.5|-0.7|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.7|-4.5|= 0.0082
71684599|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.547||||0.0453|TWO_SIDED|95.0|0.303|0.987|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.987|0.303|0.0453
71917199|NCT02141854|143356329|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.121||||0.0094|TWO_SIDED|95.0|-0.213|-0.03||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.030|-0.213|0.0094
71917200|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.702||||0|TWO_SIDED|95.0|-1.001|-0.403||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.403|-1.001|0.0000
71917201|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.607||||0.0001|TWO_SIDED|95.0|-0.908|-0.307||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.307|-0.908|0.0001
71917202|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-1.066||||0|TWO_SIDED|95.0|-1.365|-0.766||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.766|-1.365|0.0000
71917203|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.989||||0|TWO_SIDED|95.0|-1.291|-0.686||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.686|-1.291|0.0000
71917204|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.364||||0.016|TWO_SIDED|95.0|-0.659|-0.068||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.068|-0.659|0.0160
71917205|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.382||||0.0124|TWO_SIDED|95.0|-0.681|-0.083||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||-0.083|-0.681|0.0124
71917206|NCT02141854|143356330|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|-0.287||||0.0588|TWO_SIDED|95.0|-0.584|0.011||Significance level of 0.05.|Wilcoxon (Mann-Whitney)|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.||0.011|-0.584|0.0588
71917207|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Significance level of 0.05.|Log Rank|||||||0.0001
71917208|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
71917209|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||||||Significance level of 0.05.|Log Rank|||||||0.0003
71917210|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Significance level of 0.05.|Log Rank|||||||<.0001
71917211|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7203||||||Significance level of 0.05.|Log Rank|||||||0.7203
71684600|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.133||||0.0184|TWO_SIDED|95.0|0.025|0.712|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.712|0.025|0.0184
71917212|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.996||||||Significance level of 0.05.|Log Rank|||||||0.9960
71917213|NCT02141854|143356331|SUPERIORITY_OR_OTHER_LEGACY|||||||0.325||||||Significance level of 0.05.|Log Rank|||||||0.3250
71917214|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.473||||0|TWO_SIDED|95.0|0.269|0.677||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.677|0.269|0.0000
71917215|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.428||||0|TWO_SIDED|95.0|0.224|0.632||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.632|0.224|0.0000
71684601|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.103|||<|0.0001|TWO_SIDED|95.0|1.072|1.134|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.134|1.072|<0.0001
71876465|NCT03627767|143271395|SUPERIORITY||LSM difference|-5.5|||<|0.0001|TWO_SIDED|95.0|-7.4|-3.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.6|-7.4|< 0.0001
71876466|NCT03627767|143271395|SUPERIORITY||LSM difference|-2.9|||||TWO_SIDED|95.0|-4.2|-1.6||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.6|-4.2|
71876467|NCT03627767|143271395|SUPERIORITY||LSM difference|-2.4|||=|0.0313|TWO_SIDED|95.0|-4.5|-0.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.2|-4.5|= 0.0313
71917216|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.623||||0|TWO_SIDED|95.0|0.418|0.828||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.828|0.418|0.0000
71917217|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||Slope|0.681||||0|TWO_SIDED|95.0|0.478|0.885||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.885|0.478|0.0000
71876468|NCT03627767|143271395|SUPERIORITY||LSM difference|-5.1|||<|0.0001|TWO_SIDED|95.0|-7.1|-3.0|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-3.0|-7.1|< 0.0001
71876469|NCT03627767|143271395|SUPERIORITY||LSM difference|-2.7|||||TWO_SIDED|95.0|-4.1|-1.3||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.3|-4.1|
71876470|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.1|||=|0.4832|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.4|= 0.4832
71876471|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.1|||=|0.6553|TWO_SIDED|95.0|-0.3|0.2|||Mixed Models Analysis|||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.2|-0.3|= 0.6553
71876472|NCT03627767|143271396|SUPERIORITY||LSM difference|0.0|||||TWO_SIDED|95.0|-0.2|0.3||||||Week 12: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||0.3|-0.2|
71876473|NCT03627767|143271396|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.5|-1.1|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.1|-1.5|< 0.0001
71876474|NCT03627767|143271396|SUPERIORITY||LSM difference|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.7|||Mixed Models Analysis|||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.7|-2.2|< 0.0001
71876475|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.7|||||TWO_SIDED|95.0|-0.9|-0.4||||||Week 16: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.4|-0.9|
71876476|NCT03627767|143271396|SUPERIORITY||LSM difference|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.0|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.0|-1.7|< 0.0001
71876477|NCT03627767|143271396|SUPERIORITY||LSM difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.8|||Mixed Models Analysis|||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.8|-2.5|< 0.0001
71876478|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 28: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
71684602|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.543||||0.0019|TWO_SIDED|95.0|0.37|0.798|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.798|0.370|0.0019
71684603|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.359||||0.0017|TWO_SIDED|95.0|0.189|0.679|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.679|0.189|0.0017
71917218|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.15||||0.149|TWO_SIDED|95.0|-0.054|0.354||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.354|-0.054|0.1490
71917219|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.253||||0.0143|TWO_SIDED|95.0|0.051|0.455||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.455|0.051|0.0143
71917220|NCT02141854|143356332|SUPERIORITY_OR_OTHER_LEGACY||LSM difference|0.209||||0.0435|TWO_SIDED|95.0|0.006|0.411||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).||0.411|0.006|0.0435
71917221|NCT01201967|143356342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.68||||0.002|TWO_SIDED|95.0|2.14|9.22|||Mixed Models Analysis|||||9.22|2.14|0.002
71917222|NCT01201967|143356343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.045|TWO_SIDED|95.0|-4.06|-0.05|||Mixed Models Analysis|||||-0.05|-4.06|0.045
71917223|NCT01201967|143356344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.55|TWO_SIDED|95.0|-0.93|1.76|||Mixed Models Analysis|||||1.76|-0.93|0.55
71917224|NCT01201967|143356345|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.9|||Chi-squared|||||24.9|5.20|<0.001
71917225|NCT01201967|143356346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.28|TWO_SIDED|95.0|-0.51|1.76|||Mixed Models Analysis|||||1.76|-0.51|0.28
71917226|NCT01201967|143356347|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.83|TWO_SIDED|95.0|0.63|1.46|||Chi-squared|||||1.46|0.63|0.83
71917227|NCT01201967|143356348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11||||0.029|TWO_SIDED|95.0|0.012|0.22|||Mixed Models Analysis|||||0.22|0.012|0.029
71917228|NCT01201967|143356349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.59||||0.005|TWO_SIDED|95.0|1.71|9.46|||Mixed Models Analysis|||||9.46|1.71|0.005
71917229|NCT01201967|143356350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.11|TWO_SIDED|95.0|-0.54|5.14|||Mixed Models Analysis|||||5.14|-0.54|0.11
71917230|NCT03128307|143356363|SUPERIORITY||||||<|0.0001||||||Assuming a priori threshold for statistical significant of p = 0.05|t-test, 2 sided|||||||< 0.0001
71917231|NCT03128307|143356364|SUPERIORITY||||||<|0.0001||||||a priori threshold for statistical significance of p = 0.05|t-test, 2 sided|||||||< 0.0001
71917232|NCT01693562|143356395|EQUIVALENCE|Other||||||0.016|||||||Regression, Cox|||||||0.016
71917233|NCT01693562|143356396|EQUIVALENCE|Other||||||0.0046|||||||Regression, Cox|||||||0.0046
71917234|NCT02987205|143356419|NON_INFERIORITY|If the upper bound of this 95% CI was less than the prespecified non-inferiority limit of 0.50, the Test product would be claimed to be non-inferior to the Comparator product.||||||0.013||||||Wilcoxon matched-pairs signed rank test|Wilcoxon (Mann-Whitney)|||||||0.0130
71684604|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08|||<|0.0001|TWO_SIDED|95.0|1.047|1.114|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.114|1.047|<0.0001
71684605|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.093||||0.0042|TWO_SIDED|95.0|1.029|1.162|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.162|1.029|0.0042
71684606|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.535||||0.0168|TWO_SIDED|95.0|0.32|0.893|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.893|0.320|0.0168
71684607|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.501||||0.0128|TWO_SIDED|95.0|0.291|0.864|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.864|0.291|0.0128
71684608|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.853||||0.4634|TWO_SIDED|95.0|0.558|1.305|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.305|0.558|0.4634
71684609|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.655|||<|0.0001|TWO_SIDED|95.0|9.725|39.722|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (Rapid Virological Response \[RVR\] vs No RVR/EVR \[Early Virological Response\]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||39.722|9.725|<0.0001
71684610|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.569|||<|0.0001|TWO_SIDED|95.0|4.408|16.658|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR \[Complete Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||16.658|4.408|<0.0001
71684611|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.519||||0.0089|TWO_SIDED|95.0|1.26|5.034|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR \[Partial Early Virological Response\] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.034|1.260|0.0089
71684612|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.908||||0.0037|TWO_SIDED|95.0|0.851|0.969|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.969|0.851|0.0037
71684613|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.553||||0.002|TWO_SIDED|95.0|0.379|0.805|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.805|0.379|0.0020
71684614|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.537||||0.0003|TWO_SIDED|95.0|3.654|74.849|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||74.849|3.654|0.0003
71684615|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.386||||0.0733|TWO_SIDED|95.0|0.87|22.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||22.114|0.870|0.0733
71684616|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.352||||0.3478|TWO_SIDED|95.0|0.394|14.031|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||14.031|0.394|0.3478
71684617|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.729||||0.0264|TWO_SIDED|95.0|0.552|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.964|0.552|0.0264
71684618|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.658||||0.0096|TWO_SIDED|95.0|1.586|27.946|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||27.946|1.586|0.0096
71684619|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.734||||0.0421|TWO_SIDED|95.0|1.057|21.203|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.203|1.057|0.0421
71684620|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.602||||0.6004|TWO_SIDED|95.0|0.09|4.014|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.014|0.090|0.6004
71684621|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.715||||0.0418|TWO_SIDED|95.0|0.517|0.988|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.988|0.517|0.0418
71684622|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.198||||0.0279|TWO_SIDED|95.0|0.047|0.839|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||0.839|0.047|0.0279
71684623|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|40.88|||<|0.0001|TWO_SIDED|95.0|7.474|223.61|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||223.61|7.474|<0.0001
71684624|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|42.395|||<|0.0001|TWO_SIDED|95.0|8.724|206.02|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||206.02|8.724|<0.0001
71876479|NCT03627767|143271396|SUPERIORITY||LSM difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.4|< 0.0001
71876480|NCT03627767|143271396|SUPERIORITY||LSM difference|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.4|||Mixed Models Analysis|||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.4|-2.2|< 0.0001
71876481|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.8|||||TWO_SIDED|95.0|-1.1|-0.5||||||Week 40: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.5|-1.1|
71876482|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.8|||=|0.002|TWO_SIDED|95.0|-1.2|-0.3|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.3|-1.2|= 0.0020
71876483|NCT03627767|143271396|SUPERIORITY||LSM difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.2|||Mixed Models Analysis|||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-1.2|-2.2|< 0.0001
71876484|NCT03627767|143271396|SUPERIORITY||LSM difference|-0.9|||||TWO_SIDED|95.0|-1.3|-0.6||||||Week 52: The LSM differences between treatment groups were derived from the statistical model. MMRM contained fixed factors of treatment, visit, treatment by visit interaction, baseline disease severity, randomization strata, baseline value and an unstructured covariance matrix.||-0.6|-1.3|
71876485|NCT01798992|143271412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.685
71876486|NCT01798992|143271413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|TWO_SIDED||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.||||0.071
71876487|NCT03823404|143271419|SUPERIORITY||||||<|0.0455||||||The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.|mixed-effects model for repeated measure|||||||<0.0455
71876488|NCT03823404|143271420|SUPERIORITY||||||<|455|||||||Mixed Models Analysis|||||||<0455
71876489|NCT02308007|143271427|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||||||0.030
71876490|NCT02308007|143271427|SUPERIORITY|||||||0.073|||||||Chi-squared, Corrected|||||||0.073
71876491|NCT02308007|143271427|SUPERIORITY|||||||0.0204|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0204
71876492|NCT02308007|143271427|SUPERIORITY|||||||0.0493|||||||Cochran-Mantel-Haenszel|||Stratified by race (black, white, or other race)||||0.0493
71876493|NCT02308007|143271428|SUPERIORITY|||||||0.015|||||||Chi-squared, Corrected|||||||0.015
71876494|NCT02308007|143271428|SUPERIORITY|||||||0.193|||||||Chi-squared, Corrected|||Difference for Terconazole/metronidazole vaginal gel cures minus metronidazole vaginal gel cures||||0.193
71876495|NCT02308007|143271429|SUPERIORITY|||||||0.012|||||||Chi-squared, Corrected|||||||0.012
71876496|NCT02308007|143271429|SUPERIORITY|||||||0.918|||||||Chi-squared, Corrected|||||||0.918
71876497|NCT00528567|143271438|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.181|TWO_SIDED|95.0|0.72|1.07|||Log Rank|Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||||1.07|0.72|0.1810
71876498|NCT00528567|143271440|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.5247|TWO_SIDED|95.0|0.74|1.17|||Log Rank|Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery||||1.17|0.74|0.5247
71876499|NCT00528567|143271442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1966|TWO_SIDED|95.0|0.71|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.71|0.1966
71684625|NCT01066793|142887221|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.247||||0.0087|TWO_SIDED|95.0|1.704|39.908|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||39.908|1.704|0.0087
71876500|NCT00528567|143271443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.2318|TWO_SIDED|95.0|0.64|1.12|||Log Rank|||||1.12|0.64|0.2318
71876501|NCT00528567|143271446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.2792|TWO_SIDED|95.0|0.72|1.1|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.10|0.72|0.2792
71876502|NCT00528567|143271448|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87||||0.1832|TWO_SIDED|95.0|0.72|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.07|0.72|0.1832
71876503|NCT00528567|143271450|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.3309|TWO_SIDED|95.0|0.72|1.12|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||1.12|0.72|0.3309
71876504|NCT01191541|143271462|NON_INFERIORITY|The primary objective was to demonstrate the noninferiority of DNR alone to DNR+ARA-C in the rate of DFS at 2 years. Assuming a 95% rate of DFS in the two groups, a margin of -15% , 5% type 1 error, 80% power, 30 evaluable patients per group were required to draw a noninferiority conclusion.|||||<|0.05||||||the p-value is not adjusted|Log Rank|||The characteristics of all of the included patients were summarized using cross-tabulations (for categorical variables) and quantiles. Nonparametric tests were used to analyse comparisons between groups .EFS、disease-free survival (DFS) and OS were estimated using the Kaplan -Meier method, and log-rank tests were used. All P values were two-sided, and those with values of 0.05 or less were considered to be statistically significant.||||<0.05
71876505|NCT00056862|143271522|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||Null hypothesis: first phase decline in HCV RNA are the same for the two groups||||0.002
71876506|NCT00056862|143271524|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups||||0.2
71876507|NCT00056862|143271525|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|95.0|||||Log Rank|||Null hypothesis: the time to negativity for the two groups are same||||0.047
71876508|NCT00006392|143271578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.01|TWO_SIDED|99.0|0.95|1.35||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.35|0.95|< .01
71876509|NCT00006392|143271578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.01|TWO_SIDED|99.0|0.87|1.24||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.||1.24|0.87|< .01
71876510|NCT00006392|143271578|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||<|0.01||99.0|0.88|1.25||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.||1.25|.88|< .01
71876511|NCT00006392|143271579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||>|0.05||99.0|0.64|1.55||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.55|.64|> .05
71876512|NCT00006392|143271579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12|||>|0.01|TWO_SIDED|99.0|0.73|1.72||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.72|0.73|> .01
71876513|NCT00006392|143271579|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16|||>|0.01|TWO_SIDED|99.0|0.9|1.16||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|||1.16|0.90|>.01
71876514|NCT00006392|143271580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|||>|0.05|TWO_SIDED|99.0|0.69|1.73||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.73|0.69|> .05
71917235|NCT02362594|143356424|SUPERIORITY||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|98.4|0.43|0.74||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.74|0.43|<0.0001
71917236|NCT02362594|143356425|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.69||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \[\>1 mm metastasis\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.||0.69|0.42|<0.0001
71917237|NCT04167514|143356435|SUPERIORITY||Odds Ratio (OR)|1.92||||0.034|TWO_SIDED|95.0|0.954|3.866|||One-sided Wald|One-sided Wald test of superior odds of overall response under AAT treatment compared to placebo.Threshold of significance at \<0.025.|Wald CIs|||3.866|0.954|0.034
71917238|NCT04437511|143356452|SUPERIORITY||LS Mean change difference (Final Values)|2.92|STANDARD_ERROR_OF_MEAN|0.72|<|0.001|TWO_SIDED|95.0|1.508|4.331|||Mixed Models Analysis|||||4.331|1.508|<0.001
71917239|NCT04437511|143356453|SUPERIORITY||LS Mean change difference (Final Values)|3.25|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.883|4.618|||Mixed Models Analysis|||||4.618|1.883|<0.001
71876515|NCT00006392|143271580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|||>|0.05|TWO_SIDED|99.0|0.66|1.67||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||1.67|0.66|> .05
71917240|NCT04437511|143356454|SUPERIORITY||LS Mean change difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.19||0.012|TWO_SIDED|95.0|0.104|0.841|||Mixed Models Analysis|||||0.841|0.104|0.012
71876516|NCT00006392|143271580|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28|||>|0.05|TWO_SIDED|99.0|0.82|2.0||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.||2.00|0.82|> .05
71917241|NCT04437511|143356455|SUPERIORITY||LS Mean change difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.2||0.016|TWO_SIDED|95.0|0.089|0.868|||Mixed Models Analysis|||||0.868|0.089|0.016
71917242|NCT04437511|143356456|SUPERIORITY||LS Mean change difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.39||0.0006|TWO_SIDED|95.0|-2.086|-0.565|||Mixed Models Analysis|||||-0.565|-2.086|0.0006
71917243|NCT04437511|143356457|SUPERIORITY||LS Mean change difference (Final Values)|-1.52|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.25|-0.794|||Mixed Models Analysis|||||-0.794|-2.250|<0.001
71917244|NCT04437511|143356458|SUPERIORITY||LS Mean change difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.127|<|0.001|TWO_SIDED|95.0|-0.95|-0.45|||Mixed Models Analysis|||||-0.45|-0.95|<0.001
71917245|NCT04437511|143356459|SUPERIORITY||LS Mean change difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.141|<|0.001|TWO_SIDED|95.0|-0.95|-0.4|||Mixed Models Analysis|||||-0.40|-0.95|<0.001
71917246|NCT04437511|143356460|SUPERIORITY||LS Mean change difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.44||0.0001|TWO_SIDED|95.0|0.84|2.566|||Mixed Models Analysis|||||2.566|0.840|0.0001
71917247|NCT04437511|143356461|SUPERIORITY||LS Mean change difference (Final Values)|1.83|STANDARD_ERROR_OF_MEAN|0.47|<|0.001|TWO_SIDED|95.0|0.913|2.748|||Mixed Models Analysis|||||2.748|0.913|<0.001
71876517|NCT00006392|143271581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03|||>|0.05|TWO_SIDED|99.0|0.91|1.17||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.17|0.91|> .05
71917248|NCT04437511|143356462|SUPERIORITY||LS Mean change difference (Final Values)|-86.37|STANDARD_ERROR_OF_MEAN|1.275|<|0.0001|TWO_SIDED|95.0|-88.87|-83.87|||Mixed Models Analysis|||||-83.87|-88.87|<0.0001
71917249|NCT04437511|143356463|SUPERIORITY||LS Mean change difference (Final Values)|-0.0041||||0.4522|TWO_SIDED|95.0|-0.0148|0.0066|||ANCOVA|||||0.0066|-0.0148|0.4522
71917250|NCT04437511|143356464|SUPERIORITY||LS Mean change difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.007||0.002|TWO_SIDED|95.0|0.01|0.04|||Mixed Models Analysis|||Bilateral Hippocampus||0.04|0.01|0.002
71917251|NCT04437511|143356464|SUPERIORITY||LS Mean change difference (Final Values)|-6.66|STANDARD_ERROR_OF_MEAN|0.561|<|0.001|TWO_SIDED|95.0|-7.76|-5.56|||Mixed Models Analysis|||Bilateral Whole Brain||-5.56|-7.76|<0.001
71917252|NCT04437511|143356464|SUPERIORITY||LS Mean change difference (Final Values)|3.02|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|2.52|3.52|||Mixed Models Analysis|||Bilateral Ventricles||3.52|2.52|<0.001
71917253|NCT05306964|143356471|OTHER|||||||0.5|||||||GLMM|||||||0.5
71917254|NCT05306964|143356472|OTHER|||||||0.4|||||||GLMM|||||||0.4
71917255|NCT05306964|143356473|OTHER|||||||0.5|||||||GLMM|||||||0.5
71917256|NCT05306964|143356474|OTHER|||||||0.3|||||||GLMM|||||||0.3
71917257|NCT05306964|143356475|OTHER|||||||0.4|||||||GLMM|||||||0.4
71917258|NCT05306964|143356476|OTHER|||||||0.5|||||||GLMM|||||||0.5
71917259|NCT05306964|143356477|OTHER|||||||0.3|||||||GLMM|||||||0.3
71917260|NCT05306964|143356478|OTHER|||||||0.3|||||||GLMM|||||||0.3
71917261|NCT05306964|143356479|OTHER|||||||0.7|||||||GLMM|||||||0.7
71917262|NCT05306964|143356480|OTHER|||||||0.2|||||||GLMM|||||||0.2
71917263|NCT05306964|143356481|OTHER|||||||0.02|||||||GLMM|||||||0.02
71917264|NCT05306964|143356482|OTHER|||||||0.2|||||||GLMM|||||||0.2
71917265|NCT05306964|143356483|OTHER|||||||0.7|||||||GLMM|||||||0.7
71917266|NCT05306964|143356484|OTHER|||||||0.1|||||||GLMM|||||||0.1
71917267|NCT05306964|143356485|OTHER|||||||0.2|||||||GLMM|||||||0.2
71917268|NCT05306964|143356486|OTHER||||||<|0.001|||||||GLMM|||||||<0.001
71917269|NCT05306964|143356487|OTHER|||||||0|||||||GLMM|||||||0
71917270|NCT05306964|143356488|OTHER|||||||0.5|||||||GLMM|||||||0.5
71917271|NCT05306964|143356489|OTHER|||||||0.9|||||||GLMM|||||||0.9
71917272|NCT05306964|143356490|OTHER|||||||0.8|||||||GLMM|||||||0.8
71917273|NCT05306964|143356491|OTHER|||||||0|||||||GLMM|||||||0
71917274|NCT05306964|143356492|OTHER|||||||0|||||||GLMM|||||||0
71917275|NCT05306964|143356493|OTHER|||||||0.2|||||||GLMM|||||||0.2
71917276|NCT05306964|143356494|OTHER|||||||0|||||||GLMM|||||||0
71917277|NCT05306964|143356495|OTHER|||||||0.9|||||||GLMM|||||||0.9
71917278|NCT05306964|143356496|OTHER|||||||0|||||||GLMM|||||||0
71917279|NCT05306964|143356497|OTHER|||||||0.9|||||||GLMM|||||||0.9
71917280|NCT05306964|143356498|OTHER|||||||0|||||||GLMM|||||||0
71917281|NCT05306964|143356499|OTHER|||||||0|||||||GLMM|||||||0
71917282|NCT05306964|143356500|OTHER|||||||0|||||||GLMM|||||||0
71917283|NCT05306964|143356501|OTHER|||||||0.5|||||||GLMM|||||||0.5
71917284|NCT05306964|143356502|OTHER|||||||0.2|||||||GLMM|||||||0.2
71917285|NCT05306964|143356503|OTHER|||||||0.3|||||||GLMM|||||||0.3
71876518|NCT00006392|143271581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01|||>|0.05|TWO_SIDED|99.0|0.89|1.15||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.15|0.89|> .05
71876519|NCT00006392|143271581|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02|||>|0.05||99.0|0.9|1.16||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.||1.16|0.90|> .05
71876520|NCT00006392|143271582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||>|0.05||99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo is the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
71876521|NCT00006392|143271582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99|||>|0.05|TWO_SIDED|99.0|0.82|1.19||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.19|0.82|> .05
71876522|NCT00006392|143271582|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||>|0.05|TWO_SIDED|99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox|||Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.||1.13|0.77|> .05
71876523|NCT00006392|143271583|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||>|0.05|TWO_SIDED|99.0|0.88|1.09||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.09|0.88|> .05
71876524|NCT00006392|143271583|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02|||>|0.05|TWO_SIDED|99.0|0.92|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.13|0.92|> .05
71876525|NCT00006392|143271583|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.99|||>|0.05|TWO_SIDED|99.0|0.89|1.1||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.|||1.10|0.89|> .05
71876526|NCT00728481|143271586|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||Comparison between arms for a histologic response||||1.00
71876527|NCT00728481|143271591|SUPERIORITY_OR_OTHER|||||||0.76||95.0|||||Fisher Exact|||Comparison between arms for a symptomatic response||||0.76
71876528|NCT01505010|143271594|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_ERROR_OF_MEAN|8.5||0.018|TWO_SIDED||||||Mixed Models Analysis|Adjusted for the baseline 24-h systolic blood pressure|Difference at 6 months in 24-h systolic blood pressure (control minus intervention)|We used mixed models to compare blood pressure changes between randomized groups at 6 months, while adjusting for the baseline blood pressure; statistical significance was a P-value less than 0.05 on two-sided tests.||||0.018
71876529|NCT01505010|143271595|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.5|STANDARD_ERROR_OF_MEAN|4.87||0.86|TWO_SIDED||||||t-test, 2 sided|||Difference between control and intervention group at 6 months||||0.86
71876530|NCT01505010|143271596|SUPERIORITY||Median Difference (Final Values)|1.7||||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Wilcocon rank sum test||||0.032
71876531|NCT01505010|143271596|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|0.8||0.032|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.032
71876532|NCT01910116|143271613|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Assuming that an improvement in AUSCAN pain score of \>10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.||||0.014
71876533|NCT01910116|143271614|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.011
71917286|NCT03811535|143356519|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||ANCOVA|||Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.||0.2|-1.1|
71917287|NCT03811535|143356520|NON_INFERIORITY|The pre-specified non-inferiority margin was -1.8 cm/year.|Treatment difference|-0.5|||||TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, region, GH peak group and gender by age group by region interaction terms as factors and baseline height as a covariate, all nested within week as a factor.||0.2|-1.1|
71917288|NCT05564039|143356548|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.69|||Mixed Models Analysis|||||-0.69|-1.10|<0.0001
71876534|NCT01910116|143271615|SUPERIORITY_OR_OTHER|||||||0.053|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.053
71876535|NCT01910116|143271616|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.014
71876536|NCT01910116|143271617|SUPERIORITY_OR_OTHER|||||||0.728|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.728
71876537|NCT01910116|143271618|SUPERIORITY_OR_OTHER|||||||0.229|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.229
71876538|NCT01910116|143271619|SUPERIORITY_OR_OTHER|||||||0.194|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.194
71876539|NCT01910116|143271620|SUPERIORITY_OR_OTHER|||||||0.347|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.347
71876540|NCT01910116|143271621|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.122
71876541|NCT01910116|143271622|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.097
71876542|NCT01910116|143271624|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.050
71876543|NCT01910116|143271625|SUPERIORITY_OR_OTHER|||||||0.031|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.031
71876544|NCT01910116|143271626|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
71876545|NCT01910116|143271627|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.049
71876546|NCT01910116|143271628|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.221
71876547|NCT01910116|143271629|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.174
71876548|NCT01910116|143271630|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.124
71876549|NCT01910116|143271631|SUPERIORITY_OR_OTHER|||||||0.128|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.128
71876550|NCT01910116|143271632|SUPERIORITY_OR_OTHER|||||||0.126|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.126
71876551|NCT01910116|143271633|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.042
71876552|NCT01910116|143271634|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.660
71876553|NCT01910116|143271635|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
71876554|NCT01910116|143271636|SUPERIORITY_OR_OTHER|||||||0.186|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.186
71876555|NCT01910116|143271637|SUPERIORITY_OR_OTHER|||||||0.493|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.493
71876556|NCT01910116|143271638|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.062
71876557|NCT01910116|143271639|SUPERIORITY_OR_OTHER|||||||0.604|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.604
71876558|NCT01910116|143271640|SUPERIORITY_OR_OTHER|||||||0.252|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.252
71876559|NCT01910116|143271641|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||Chi-squared|||||||0.378
71876560|NCT01910116|143271642|SUPERIORITY_OR_OTHER|||||||0.485|TWO_SIDED||||||Chi-squared|||||||0.485
71876561|NCT01910116|143271643|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71876562|NCT01910116|143271644|SUPERIORITY_OR_OTHER|||||||0.683|TWO_SIDED||||||Fisher Exact|||||||0.683
71876563|NCT01910116|143271645|SUPERIORITY_OR_OTHER|||||||0.036|TWO_SIDED||||||Chi-squared|||||||0.036
71876564|NCT01910116|143271646|SUPERIORITY_OR_OTHER|||||||0.022|TWO_SIDED||||||Chi-squared|||||||0.022
71876565|NCT01910116|143271647|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||Chi-squared|||||||0.017
71684626|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.957||||0.0002|TWO_SIDED|95.0|1.383|2.77|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.770|1.383|0.0002
71684627|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.337||||0.0007|TWO_SIDED|95.0|1.661|6.705|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.705|1.661|0.0007
71876566|NCT01910116|143271648|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||Chi-squared|||||||0.060
71876567|NCT03606980|143271649|EQUIVALENCE|p\<0.05 was considered statistically significant. A 95% confidence interval was computed using logistic regression model.|Hazard Ratio (HR)|3.11||||0.0366|TWO_SIDED|95.0|1.073|9.005|||Cox proportional hazards analysis|||||9.005|1.073|0.0366
71876568|NCT03606980|143271649|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|4.16||||0.0232|TWO_SIDED|95.0|1.215|14.273|||Cox proportional hazards analysis|||||14.273|1.215|0.0232
71876569|NCT03606980|143271649|EQUIVALENCE|p\<0.05 was considered statistically significant.|Hazard Ratio (HR)|1.24||||0.64|TWO_SIDED|95.0|0.389|4.615|||Cox proportional hazards analysis|||||4.615|0.389|0.64
71917289|NCT05564039|143356549|SUPERIORITY||LS Mean difference (Final Values)|-7.4|||<|0.0001|TWO_SIDED|95.0|-8.7|-6.0|||Mixed Models Analysis|||||-6.0|-8.7|<.0001
71917290|NCT05564039|143356550|SUPERIORITY||Odds Ratio (OR)|7.13|||<|0.0001|TWO_SIDED|95.0|3.82|13.32|||Regression, Logistic|||||13.32|3.82|<0.0001
71917291|NCT05564039|143356551|SUPERIORITY||Odds Ratio (OR)|12.24|||<|0.0001|TWO_SIDED|95.0|6.51|23.02|||Regression, Logistic|||||23.02|6.51|<0.0001
71917292|NCT05564039|143356552|SUPERIORITY||Odds Ratio (OR)|15.34|||<|0.0001|TWO_SIDED|95.0|4.58|51.36|||Regression, Logistic|||||51.36|4.58|<0.0001
71917293|NCT05564039|143356553|SUPERIORITY||Odds Ratio (OR)|9.31|||<|0.0001|TWO_SIDED|95.0|5.11|16.98|||Regression, Logistic|||||16.98|5.11|<0.0001
71917294|NCT05564039|143356554|SUPERIORITY||Odds Ratio (OR)|19.35|||<|0.0001|TWO_SIDED|95.0|9.07|41.3|||Regression, Logistic|||||41.30|9.07|<0.0001
71917295|NCT05564039|143356555|SUPERIORITY||Odds Ratio (OR)|35.83|||<|0.0001|TWO_SIDED|95.0|7.18|178.89|||Regression, Logistic|||||178.89|7.18|<0.0001
71917296|NCT05564039|143356556|SUPERIORITY||Odds Ratio (OR)|20.44|||<|0.0001|TWO_SIDED|95.0|8.4|49.77|||Regression, Logistic|||||49.77|8.40|<0.0001
71917297|NCT05564039|143356557|SUPERIORITY||LS Mean difference (Final Values)|-0.9|||<|0.001|TWO_SIDED|95.0|-1.32|-0.49|||ANCOVA|||||-0.49|-1.32|<0.001
71917298|NCT05564039|143356558|SUPERIORITY||LS Mean difference (Final Values)|-5.1||||0.0002|TWO_SIDED|95.0|-7.8|-2.5|||Mixed Models Analysis|||||-2.5|-7.8|0.0002
71917299|NCT05564039|143356559|SUPERIORITY||LS Mean difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1|||Mixed Models Analysis|||||-2.1|-3.1|<0.0001
71917300|NCT05564039|143356560|SUPERIORITY||LS Mean difference (Final Values)|4.1||||0.1181|TWO_SIDED|95.0|-1.0|9.2|||ANCOVA|||||9.2|-1.0|0.1181
71917301|NCT04453722|143356561|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.12|TWO_SIDED|95.0|-0.4|0.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital TWA SpO2 \<90% (%)||0|-0.4|0.120
71917302|NCT04453722|143356561|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test|Median Difference (Final Values)|-407.0||||0.349|TWO_SIDED|95.0|-1816.0|208.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital AUC SpO2 \<90% (% \* min)||208|-1816|0.349
71876570|NCT03606980|143271650|EQUIVALENCE|All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.86|||||||ANOVA|||||||0.86
71876571|NCT03606980|143271651|EQUIVALENCE|p\<00.05 was considered statistically significant.||||||0.25|||||||ANOVA|||||||0.25
71876572|NCT03606980|143271652|EQUIVALENCE|p\<0.05 considered statistically significant.||||||0.29|||||||ANOVA|||||||0.29
71876573|NCT03606980|143271653|EQUIVALENCE|All statistical tests were performed using the SAS Studio. All statistical tests were two-sided, and p\<0.05 was considered statistically significant.||||||0.57|||||||ANOVA|||||||0.57
71876574|NCT02469896|143271657|SUPERIORITY||Risk Ratio (RR)|0.875||||0.602|TWO_SIDED|95.0|0.556|1.377|||Fisher Exact|||||1.377|0.556|0.602
71876575|NCT02469896|143271658|SUPERIORITY||||||||||||||||||No statistical data was obtain because no patients died during the trial.|||
71876576|NCT02469896|143271659|SUPERIORITY||Slope|0.099||||0.922|TWO_SIDED|95.0|-1.902|2.099||Unadjusted|Mixed Models Analysis|||||2.099|-1.902|0.922
71876577|NCT02469896|143271660|SUPERIORITY||Difference of slopes|-0.008||||0.983|TWO_SIDED|95.0|-0.761|0.745|||Mixed Models Analysis|||||0.745|-0.761|0.983
71876578|NCT02469896|143271662|SUPERIORITY||Ratio of geometric means|1.15||||0.684|TWO_SIDED|95.0|0.566|2.337|||t-test, 2 sided|||PBMC IL-6 fold-change||2.337|0.566|0.684
71876579|NCT02469896|143271662|SUPERIORITY||Ratio of geometric means|1.344||||0.663|TWO_SIDED|95.0|0.331|2.08|||t-test, 2 sided|||||2.080|0.331|0.663
71876580|NCT02469896|143271662|SUPERIORITY||Ratio of geometric means|1.198||||0.5|TWO_SIDED|95.0|0.691|2.08|||t-test, 2 sided|||||2.080|0.691|0.500
71917303|NCT04453722|143356561|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-0.1||||0.307|TWO_SIDED|95.0|-0.2|0.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge TWA SpO2 \<90% (%)||0|-0.2|0.307
71917304|NCT04453722|143356561|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-35.0||||0.431|TWO_SIDED|95.0|-195.0|67.0|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge AUC SpO2 \<90% (% \* min)||67|-195|0.431
71917305|NCT04453722|143356562|SUPERIORITY||Risk Ratio (RR)|0.96|||>|0.99|TWO_SIDED|95.0|0.22|4.27|||Fisher Exact|||variable: In hospital Any event, N (%)c||4.27|0.22|>0.99
71917306|NCT04453722|143356562|SUPERIORITY||Risk Ratio (RR)|1.0|||>|0.99|TWO_SIDED|95.0|0.35|2.9|||Chi-squared|||variable: Post-discharge Any event, N (%)||2.90|0.35|>0.99
71684628|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.305||||0.3611|TWO_SIDED|95.0|0.737|2.312|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.312|0.737|0.3611
71684629|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.943|||<|0.0001|TWO_SIDED|95.0|0.929|0.958|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.958|0.929|<0.0001
71684630|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.002|TWO_SIDED|95.0|0.615|0.897|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.897|0.615|0.0020
71684631|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.864||||0.0004|TWO_SIDED|95.0|1.322|2.628|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.628|1.322|0.0004
71876581|NCT02469896|143271663|SUPERIORITY||Ratio of fold change|0.047|||<|0.001|TWO_SIDED|95.0|0.01|0.217|||Mixed Models Analysis|||||0.217|0.010|<0.001
71876582|NCT02469896|143271663|SUPERIORITY||Ratio of fold change|1.306||||0.247|TWO_SIDED|95.0|0.828|2.059|||Mixed Models Analysis|||||2.059|0.828|0.247
71684632|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.124||||0.0386|TWO_SIDED|95.0|1.04|4.338|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||4.338|1.040|0.0386
71876583|NCT02469896|143271663|SUPERIORITY||Ratio of fold change|19.591|||<|0.001|TWO_SIDED|95.0|11.143|34.446|||Mixed Models Analysis|||||34.446|11.143|<0.001
71876584|NCT02469896|143271663|SUPERIORITY||Ratio of fold change|1.264||||0.185|TWO_SIDED|95.0|0.892|1.791|||Mixed Models Analysis|||||1.791|0.892|0.185
71876585|NCT02469896|143271663|SUPERIORITY||Ratio of fold change|1.396||||0.427|TWO_SIDED|95.0|0.608|3.206|||Mixed Models Analysis|||||3.206|0.608|0.427
71876586|NCT02469896|143271663|SUPERIORITY||Ratio of fold change|0.893||||0.285|TWO_SIDED|95.0|0.725|1.1|||Mixed Models Analysis|||||1.100|0.725|0.285
71876587|NCT02469896|143271664|SUPERIORITY||Ratio of fold change|0.167||||0.011|TWO_SIDED|95.0|0.043|0.643|||Mixed Models Analysis|||||0.643|0.043|0.011
71876588|NCT02469896|143271664|SUPERIORITY||Ratio of fold change|0.741||||0.604|TWO_SIDED|95.0|0.228|2.405|||Mixed Models Analysis|||||2.405|0.228|0.604
71876589|NCT02469896|143271664|SUPERIORITY||Ratio of fold change|2.94|||<|0.001|TWO_SIDED|95.0|1.823|4.74|||Mixed Models Analysis|||||4.740|1.823|<0.001
71876590|NCT02469896|143271664|SUPERIORITY||Ratio of fold change|1.078||||0.587|TWO_SIDED|95.0|0.813|1.431|||Mixed Models Analysis|||||1.431|0.813|0.587
71876591|NCT02469896|143271664|SUPERIORITY||Ratio of fold change|1.078||||0.697|TWO_SIDED|95.0|0.728|1.595|||Mixed Models Analysis|||||1.595|0.728|0.697
71876592|NCT02469896|143271665|SUPERIORITY||Ratio of fold change|1.785|||<|0.001|TWO_SIDED|95.0|1.502|2.121|||Mixed Models Analysis|||||2.121|1.502|<0.001
71876593|NCT01294150|143271668|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance|t-test, 2 sided|||||||0.003
71876594|NCT01624259|143271728|NON_INFERIORITY_OR_EQUIVALENCE|"Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy.~This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks."|LS Mean Difference|-0.06|||<|0.001|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment).|Mixed Models Analysis|||To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two-sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.||0.07|-0.19|<0.001
71876595|NCT01624259|143271728|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.186|TWO_SIDED|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment)|Mixed Models Analysis|||Superiority analysis||0.07|-0.19|0.186
71876596|NCT01624259|143271729|SUPERIORITY_OR_OTHER||LS Mean Difference|0.71|STANDARD_ERROR_OF_MEAN|0.28||0.01|TWO_SIDED|95.0|0.17|1.26||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model at 26 weeks.||1.26|0.17|0.010
71876597|NCT01624259|143271730|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.1||0.013|TWO_SIDED|95.0|0.05|0.45||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||0.45|0.05|0.013
71876598|NCT01624259|143271731|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|2.61||0.828|TWO_SIDED|95.0|-5.69|4.56||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.||4.56|-5.69|0.828
71876599|NCT01624259|143271732|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25|STANDARD_ERROR_OF_MEAN|1.86||0.228|TWO_SIDED|95.0|-5.91|1.41||No adjustment for multiplicity.|Mixed Models Analysis|P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM.||||1.41|-5.91|0.228
71876600|NCT01624259|143271733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.322|TWO_SIDED|95.0|0.81|1.86||P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).|Regression, Logistic|No adjustment for multiplicity.||Treatment comparison for HbA1c levels ≤6.5%||1.86|0.81|0.322
71876601|NCT01624259|143271733|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.925|TWO_SIDED|95.0|0.64|1.63||No adjustment for multiplicity.|Regression, Logistic|P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).||Treatment comparison for HbA1c levels \<7.0%.||1.63|0.64|0.925
71876602|NCT01624259|143271734|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.79||0.608|TWO_SIDED|95.0|-4.06|6.92|||ANCOVA|No adjustment for multiplicity.||||6.92|-4.06|0.608
71876603|NCT00782288|143271751|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Measures were compared between Baseline, Treatment \& Recovery periods to determine if changes from baseline differed between placebo and the two digitoxin dose levels. Kruskal-Wallis equity of population rank test was performed on the changes Day 28 minus Day 1. To compare the change from baseline to treatment period between the two arms, a Wilcoxon rank sum test was performed. To determine whether induced sputum Il-8 returned to baseline at the final visit, a one sample sign test was performed.||||>0.05
71876604|NCT00782288|143271757|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Baseline,Treatment and Recovery periods were compared to determine if changes from baseline differed between placebo and the two digitoxin doses.||||>0.05
71876605|NCT01479829|143271766|SUPERIORITY||Chi-square value|5.3466||||0.02|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 5.3466.|The null hypothesis is that there is no difference in the response rate between patients assigned to the intervention cohort or control cohort.||||.02
71917307|NCT04453722|143356563|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-6.0||||0.354|TWO_SIDED|95.0|-26.0|4.0|||Wilcoxon (Mann-Whitney)|||variable: In hospital Number||4.0|-26.0|0.354
71917308|NCT04453722|143356563|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-46.1||||0.133|TWO_SIDED|95.0|-274.0|5.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Total duration (min)||5.1|-274|0.133
71917309|NCT04453722|143356563|SUPERIORITY||Median Difference (Final Values)|-24.1||||0.075|TWO_SIDED|95.0|-213.0|0.1|||Wilcoxon (Mann-Whitney)|||variable: In hospital Duration \>2 min (min)||0.1|-213|0.075
71917310|NCT04453722|143356563|SUPERIORITY||Median Difference (Final Values)|-2.0||||0.009|TWO_SIDED|95.0|-4.5|-0.4|||Wilcoxon (Mann-Whitney)|||variable: In hospital Mean duration-all patients (min)||-0.4|-4.5|0.009
71917311|NCT04453722|143356563|SUPERIORITY||Median Difference (Final Values)|-2.2||||0.001|TWO_SIDED|95.0|-4.7|-0.7|||Wilcoxon (Mann-Whitney)|||variable: in hospital mean duration for events in those with any events (min)||-0.7|-4.7|0.001
71917312|NCT04453722|143356563|SUPERIORITY||Median Difference (Final Values)|0.0||||0.584|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: post-discharge number||1.0|-4.0|0.584
71917313|NCT04453722|143356563|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and p-values from Wilcoxon rank sum test.|Median Difference (Final Values)|-1.3||||0.556|TWO_SIDED|95.0|-18.6|3.3|||Wilcoxon (Mann-Whitney)|||variable: Post-discharge duration (min)||3.3|-18.6|0.556
71917314|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.096|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (at the day of discharge)||2.0|0.0|0.096
71917315|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.205|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing sleep (at the day of discharge)||2.0|0.0|0.205
71917316|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.839|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: comfortable to wear (at the day of discharge)||0.0|-1.0|0.839
71917317|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.621|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (at the day of discharge)||0.0|0.0|0.621
71917318|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.898|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert||1.0|-1.0|0.898
71917319|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.654|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: easily cleaned/disinfected (at the day of discharge)||0.0|0.0|0.654
71876606|NCT01479829|143271767|SUPERIORITY||Chi-square value|13.3821|||<|0.001|TWO_SIDED||||||Chi-squared||The chi-square value with 1 degree of freedom was 13.3821.|The null hypothesis is that there is no difference in the remission rate between patients assigned to the intervention cohort or control cohort.||||<.001
71917320|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.929|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: adequate battery life (at the day of discharge)||1.0|-1.0|0.929
71917321|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.2|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch (at the day of discharge)||0.0|-1.0|0.200
71917322|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.987|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (at the day of discharge)||0.0|0.0|0.987
71917323|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.581|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line (at the day of discharge)||0.0|-1.0|0.581
71876607|NCT00601250|143271768|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.78|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.5|-0.78|<0.0001
71876608|NCT00601250|143271769|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.431|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.53|-0.333|||ANCOVA|||Linagliptin vs. Placebo||-0.333|-0.530|<0.0001
71876609|NCT00601250|143271770|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.596|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001||95.0|-0.721|-0.471|||ANCOVA|||Linagliptin vs. Placebo||-0.471|-0.721|<0.0001
71876610|NCT00601250|143271771|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.648|STANDARD_ERROR_OF_MEAN|0.069|<|0.0001||95.0|-0.785|-0.512|||ANCOVA|||Linagliptin vs. Placebo||-0.512|-0.785|<0.0001
71876611|NCT00601250|143271772|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-21.13|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001||95.0|-27.3|-14.96|||ANCOVA|||Linagliptin vs. Placebo||-14.96|-27.3|<0.0001
71876612|NCT00601250|143271773|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.52|STANDARD_ERROR_OF_MEAN|2.67|<|0.0001||95.0|-21.76|-11.29|||ANCOVA|||Linagliptin vs. Placebo||-11.29|-21.76|<0.0001
71876613|NCT00601250|143271774|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.73|STANDARD_ERROR_OF_MEAN|2.91|<|0.0001||95.0|-22.44|-11.01|||ANCOVA|||Linagliptin vs. Placebo||-11.01|-22.44|<0.0001
71876614|NCT00601250|143271775|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.83|STANDARD_ERROR_OF_MEAN|3.05|<|0.0001||95.0|-26.81|-14.84|||ANCOVA|||Linagliptin vs. Placebo||-14.84|-26.81|<0.0001
71876615|NCT00601250|143271776|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.395|||<|0.0001||95.0|2.41|8.013|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||8.013|2.410|<0.0001
71876616|NCT00601250|143271778|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.456||||0.0016||95.0|1.907|15.614|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||15.614|1.907|0.0016
71876617|NCT00601250|143271780|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.754|||<|0.0001||95.0|2.486|5.669|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."||5.669|2.486|<0.0001
71876618|NCT00601250|143271781|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-67.13|STANDARD_ERROR_OF_MEAN|13.88|<|0.0001|TWO_SIDED|95.0|-94.69|-39.58|||ANCOVA|||Linagliptin vs. Placebo||-39.58|-94.69|<0.0001
71876619|NCT00601250|143271782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-41.8|STANDARD_ERROR_OF_MEAN|10.02|<|0.0001|TWO_SIDED|95.0|-61.71|-21.89|||ANCOVA|||Linagliptin vs. Placebo||-21.89|-61.71|<0.0001
71876620|NCT01791803|143271789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.6|||||TWO_SIDED|95.0|1.1|11.4||||||||11.4|1.1|
71876621|NCT01791803|143271789|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.4|||||TWO_SIDED|95.0|1.04|9.7||||||||9.7|1.04|
71876622|NCT01791803|143271790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.0|||||TWO_SIDED|95.0|0.8|6.2||||Adjusted for gender, marital status, diagnosis at enrollment.||||6.2|0.8|
71876623|NCT01791803|143271790|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.2|10.0||||||||10|1.2|
71876624|NCT01791803|143271791|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis||||< 0.001
71876625|NCT01791803|143271791|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANOVA|||Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness||||0.07
71876626|NCT00594516|143271806|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.|Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.09||||95.0|-0.09|0.28||||||Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.||0.28|-0.09|
71876627|NCT01448213|143271829|SUPERIORITY_OR_OTHER|||||||0.17|||||||Log Rank|||||||0.17
71876628|NCT01448213|143271830|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Log Rank|||||||0.0005
71684633|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.398||||0.0004|TWO_SIDED|95.0|1.722|6.706|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.706|1.722|0.0004
71917324|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.18|TWO_SIDED|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)|||variable: Degree of disturbing daily life except sleep (after 24 hours of discharge)||3.0|0.0|0.180
71917325|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|1.0||||0.171|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||variable: degree of distributing sleep (after 24 hours of discharge)||2.0|0.0|0.171
71917326|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.074|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert (after 24 hours of discharge)||0.0|-1.0|0.074
71917327|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.414|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to tactile alert (after 24 hours of discharge)||1.0|-2.0|0.414
71917328|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.506|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Easily cleaned/disinfected (after 24 hours of discharge)||0.0|0.0|0.506
71917329|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.747|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life (after 24 hours of discharge)||0.0|-1.0|0.747
71917330|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|-1.0||||0.023|TWO_SIDED|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: satisfy with the electrode patch (after 24 hours of discharge)||0.0|-2.0|0.023
71917331|NCT04453722|143356566|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test|Median Difference (Final Values)|0.0||||0.023|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study (after 24 hours of discharge)||0.0|-1.0|0.023
71917332|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.73|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Degree of disturbing routine work||0.0|-1.0|0.73
71917333|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.097|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||Easily cleaned/disinfected||1.0|0.0|0.097
71917334|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|1.0||||0.02|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Adequate battery life||1.0|0.0|0.02
71917335|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.037|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Satisfy with the electrode patch||1.0|0.0|0.037
71917336|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.482|TWO_SIDED|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Tolerable to audible alert||1.0|-2.0|0.482
71917337|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.031|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||variable: Willing to use after study||1.0|0.0|0.031
71917338|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.947|TWO_SIDED|95.0|0.0|1.0||variable: Patients' complaint about the device|Wilcoxon (Mann-Whitney)|||variable: Patients' complaint about the device||1.0|0.0|0.947
71917339|NCT04453722|143356567|SUPERIORITY|Median difference was estimated from the Hodges-Lehmann estimator of location shift between groups and P values from Wilcoxon rank sum test.|Median Difference (Final Values)|0.0||||0.324|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||variable: Disturb IV line||0.0|0.0|0.324
71917340|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|||||TWO_SIDED|95.0|-0.755|-0.386||||||||-0.386|-0.755|
71917341|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.762|||||TWO_SIDED|95.0|-0.925|-0.598||||||||-0.598|-0.925|
71917342|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.826|||||TWO_SIDED|95.0|-0.987|-0.665||||||||-0.665|-0.987|
71917343|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.887|||||TWO_SIDED|95.0|-1.035|-0.739||||||||-0.739|-1.035|
71917344|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.351|||||TWO_SIDED|95.0|-0.57|-0.132||||||||-0.132|-0.570|
71917345|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.542|||||TWO_SIDED|95.0|-0.743|-0.342||||||||-0.342|-0.743|
71917346|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.607|||||TWO_SIDED|95.0|-0.808|-0.406||||||||-0.406|-0.808|
71917347|NCT01263470|143356568|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.667|||||TWO_SIDED|95.0|-0.859|-0.475||||||||-0.475|-0.859|
71917348|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|||||TWO_SIDED|95.0|-0.213|-0.104||||||||-0.104|-0.213|
71684634|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.2769|TWO_SIDED|95.0|0.776|2.428|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.428|0.776|0.2769
71684635|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.945|||<|0.0001|TWO_SIDED|95.0|0.931|0.96|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.960|0.931|<0.0001
71684636|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.163||||0.0001|TWO_SIDED|95.0|1.078|1.256|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.256|1.078|0.0001
71917349|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174|||||TWO_SIDED|95.0|-0.234|-0.114||||||||-0.114|-0.234|
71917350|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.219|-0.1||||||||-0.100|-0.219|
71917351|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.153|||||TWO_SIDED|95.0|-0.212|-0.095||||||||-0.095|-0.212|
71917352|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.059|||||TWO_SIDED|95.0|-0.116|-0.003||||||||-0.003|-0.116|
71917353|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.075|||||TWO_SIDED|95.0|-0.136|-0.014||||||||-0.014|-0.136|
71917354|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.061|||||TWO_SIDED|95.0|-0.121|0.0||||||||0.000|-0.121|
71917355|NCT01263470|143356569|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.054|||||TWO_SIDED|95.0|-0.114|0.006||||||||0.006|-0.114|
71917356|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.326|||||TWO_SIDED|95.0|-0.419|-0.233||||||||-0.233|-0.419|
71917357|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.369|||||TWO_SIDED|95.0|-0.47|-0.268||||||||-0.268|-0.470|
71917358|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34|||||TWO_SIDED|95.0|-0.438|-0.241||||||||-0.241|-0.438|
71917359|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.387|||||TWO_SIDED|95.0|-0.485|-0.288||||||||-0.288|-0.485|
71917360|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.178|||||TWO_SIDED|95.0|-0.28|-0.076||||||||-0.076|-0.280|
71917361|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.221|||||TWO_SIDED|95.0|-0.329|-0.112||||||||-0.112|-0.329|
71917362|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.192|||||TWO_SIDED|95.0|-0.299|-0.085||||||||-0.085|-0.299|
71917363|NCT01263470|143356570|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|||||TWO_SIDED|95.0|-0.346|-0.131||||||||-0.131|-0.346|
71917364|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|||||TWO_SIDED|95.0|-0.644|-0.356||||||||-0.356|-0.644|
71917365|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.614|||||TWO_SIDED|95.0|-0.763|-0.464||||||||-0.464|-0.763|
71917366|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|||||TWO_SIDED|95.0|-0.804|-0.516||||||||-0.516|-0.804|
71917367|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.695|||||TWO_SIDED|95.0|-0.832|-0.559||||||||-0.559|-0.832|
71917368|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.325|||||TWO_SIDED|95.0|-0.494|-0.156||||||||-0.156|-0.494|
71917369|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.438|||||TWO_SIDED|95.0|-0.61|-0.267||||||||-0.267|-0.610|
71917370|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.485|||||TWO_SIDED|95.0|-0.654|-0.315||||||||-0.315|-0.654|
71917371|NCT01263470|143356571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||||TWO_SIDED|95.0|-0.683|-0.357||||||||-0.357|-0.683|
71917372|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
71917373|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
71917374|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
71917375|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
71917376|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
71917377|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
71917378|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
71917379|NCT01263470|143356572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
71917380|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|||||TWO_SIDED|95.0|-23.27|-7.93||||||||-7.93|-23.27|
71917381|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.69|||||TWO_SIDED|95.0|-25.34|-10.05||||||||-10.05|-25.34|
71917382|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.08|||||TWO_SIDED|95.0|-24.14|-8.02||||||||-8.02|-24.14|
71917383|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.47|||||TWO_SIDED|95.0|-32.06|-14.89||||||||-14.89|-32.06|
71917384|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.82|||||TWO_SIDED|95.0|-12.66|1.02||||||||1.02|-12.66|
71917385|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.92|||||TWO_SIDED|95.0|-14.76|-1.08||||||||-1.08|-14.76|
71917386|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.3|||||TWO_SIDED|95.0|-13.53|0.93||||||||0.93|-13.53|
71917387|NCT01263470|143356573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.69|||||TWO_SIDED|95.0|-21.45|-5.94||||||||-5.94|-21.45|
71917388|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.73|||||TWO_SIDED|95.0|-26.52|-8.94||||||||-8.94|-26.52|
71917389|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.22|||||TWO_SIDED|95.0|-32.07|-16.37||||||||-16.37|-32.07|
71917390|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.34|||||TWO_SIDED|95.0|-32.03|-16.65||||||||-16.65|-32.03|
71917391|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.28|||||TWO_SIDED|95.0|-37.04|-19.52||||||||-19.52|-37.04|
71917392|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.55|||||TWO_SIDED|95.0|-17.28|0.18||||||||0.18|-17.28|
71917393|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.04|||||TWO_SIDED|95.0|-22.9|-7.18||||||||-7.18|-22.90|
71917394|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.16|||||TWO_SIDED|95.0|-22.9|-7.42||||||||-7.42|-22.90|
71917395|NCT01263470|143356574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1|||||TWO_SIDED|95.0|-27.8|-10.4||||||||-10.40|-27.80|
71917396|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.92|||||TWO_SIDED|95.0|-24.19|-5.64||||||||-5.64|-24.19|
71917397|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.17|||||TWO_SIDED|95.0|-27.86|-12.48||||||||-12.48|-27.86|
71917398|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.07|||||TWO_SIDED|95.0|-30.41|-15.73||||||||-15.73|-30.41|
71917399|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.17|||||TWO_SIDED|95.0|-36.05|-20.29||||||||-20.29|-36.05|
71917400|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-15.6|3.06||||||||3.06|-15.60|
71917401|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.52|||||TWO_SIDED|95.0|-19.41|-3.64||||||||-3.64|-19.41|
71917402|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.42|||||TWO_SIDED|95.0|-22.04|-6.8||||||||-6.80|-22.04|
71917403|NCT01263470|143356575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.52|||||TWO_SIDED|95.0|-27.61|-11.43||||||||-11.43|-27.61|
71917404|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.384|0.094||||||||0.094|-0.384|
71917405|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||||TWO_SIDED|95.0|-0.106|0.374||||||||0.374|-0.106|
71917406|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|||||TWO_SIDED|95.0|-0.103|0.39||||||||0.390|-0.103|
71917407|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|||||TWO_SIDED|95.0|-0.218|0.227||||||||0.227|-0.218|
71917408|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|||||TWO_SIDED|95.0|-0.241|0.245||||||||0.245|-0.241|
71917409|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.281|||||TWO_SIDED|95.0|0.038|0.524||||||||0.524|0.038|
71917410|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.291|||||TWO_SIDED|95.0|0.041|0.54||||||||0.540|0.041|
71917411|NCT01263470|143356576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|||||TWO_SIDED|95.0|-0.077|0.38||||||||0.380|-0.077|
71917412|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-0.245|0.156||||||||0.156|-0.245|
71917413|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|||||TWO_SIDED|95.0|-0.185|0.21||||||||0.210|-0.185|
71917414|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|||||TWO_SIDED|95.0|-0.053|0.369||||||||0.369|-0.053|
71917415|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.14|0.235||||||||0.235|-0.140|
71917416|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.122|||||TWO_SIDED|95.0|-0.097|0.341||||||||0.341|-0.097|
71917417|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.179|||||TWO_SIDED|95.0|-0.036|0.395||||||||0.395|-0.036|
71917418|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.325|||||TWO_SIDED|95.0|0.097|0.553||||||||0.553|0.097|
71917419|NCT01263470|143356577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.215|||||TWO_SIDED|95.0|0.006|0.423||||||||0.423|0.006|
71917420|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.444|0.209||||||||0.209|-0.444|
71917421|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.362|0.162||||||||0.162|-0.362|
71917422|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|||||TWO_SIDED|95.0|-0.166|0.324||||||||0.324|-0.166|
71917423|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.117|||||TWO_SIDED|95.0|-0.355|0.121||||||||0.121|-0.355|
71876629|NCT00785044|143271835|SUPERIORITY_OR_OTHER|Analysis was performed using the null hypothesis for the AUC stated as: H0: θ ≤A versus H1: θ \>A, where the AUC (θ) value was: 'A' selected based on the diagnostic utility desired from the use of myocardial 123 I-mIBG uptake measured using H/M ratio. A smooth parametric model of the ROC curve was fitted to the data. The AUC for the resulting model was calculated and 95% confidence interval for the AUC was reported. The hypothesis was tested using the Z-statistics at 'A' at level of 0.70.|Mean|0.581|||<|0.001|TWO_SIDED|95.0|0.532|0.63||At 0.05 level of significance.|Z-statistic|||"Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio."||0.630|0.532|<0.001
71917424|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.203|0.408||||||||0.408|-0.203|
71917425|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.124|0.364||||||||0.364|-0.124|
71917426|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.299|||||TWO_SIDED|95.0|0.071|0.526||||||||0.526|0.071|
71917427|NCT01263470|143356578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||||TWO_SIDED|95.0|-0.118|0.322||||||||0.322|-0.118|
71917428|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.23|0.308||||||||0.308|-0.230|
71917429|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|-0.029|0.379||||||||0.379|-0.029|
71917430|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.248|||||TWO_SIDED|95.0|0.044|0.453||||||||0.453|0.044|
71917431|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||||TWO_SIDED|95.0|-0.035|0.407||||||||0.407|-0.035|
71917432|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-0.236|0.34||||||||0.340|-0.236|
71917433|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|||||TWO_SIDED|95.0|-0.044|0.421||||||||0.421|-0.044|
71917434|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|||||TWO_SIDED|95.0|0.026|0.496||||||||0.496|0.026|
71917435|NCT01263470|143356579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.199|||||TWO_SIDED|95.0|-0.049|0.448||||||||0.448|-0.049|
71876630|NCT00763971|143271836|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-18.6|||<|0.001|TWO_SIDED|95.0|-21.5|-15.7|||ANCOVA|||||-15.7|-21.5|<0.001
71876631|NCT00763971|143271836|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-13.0|||<|0.001|TWO_SIDED|95.0|-15.9|-10.2|||ANCOVA|||||-10.2|-15.9|<0.001
71876632|NCT00763971|143271837|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|63.6|||<|0.001|TWO_SIDED|95.0|53.0|74.1|||Cochran-Mantel-Haenszel|||||74.1|53.0|<0.001
71876633|NCT00763971|143271837|SUPERIORITY_OR_OTHER_LEGACY||difference in percentages|46.2|||<|0.001|TWO_SIDED|95.0|34.6|57.7|||Cochran-Mantel-Haenszel|||||57.7|34.6|<0.001
71876634|NCT00763971|143271838|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-21.3|||<|0.001|TWO_SIDED|95.0|-25.5|-17.0|||ANCOVA|||||-17.0|-25.5|<0.001
71876635|NCT00763971|143271838|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-15.1|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||ANCOVA|||||-10.9|-19.3|<0.001
71876636|NCT00763971|143271840|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|8.8|||<|0.001|TWO_SIDED|95.0|6.1|11.5|||ANCOVA|||||11.5|6.1|<0.001
71876637|NCT00763971|143271840|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|7.3|||<|0.001|TWO_SIDED|95.0|4.6|10.0|||ANCOVA|||||10.0|4.6|<0.001
71876638|NCT00763971|143271841|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.3|||<|0.001|TWO_SIDED|95.0|-0.4|-0.2|||ANCOVA|||||-0.2|-0.4|<0.001
71876639|NCT00763971|143271841|SUPERIORITY_OR_OTHER_LEGACY||difference in LS means|-0.2|||<|0.001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||||-0.1|-0.3|<0.001
71876640|NCT04439071|143271844|OTHER|||||||0.949|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.949
71917436|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.85|||||TWO_SIDED|95.0|-38.75|-8.94||||||||-8.94|-38.75|
71917437|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.38|||||TWO_SIDED|95.0|-37.14|-9.61||||||||-9.61|-37.14|
71917438|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.6|||||TWO_SIDED|95.0|-53.18|-28.02||||||||-28.02|-53.18|
71917439|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-42.75|||||TWO_SIDED|95.0|-54.93|-30.58||||||||-30.58|-54.93|
71917440|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.36|||||TWO_SIDED|95.0|-19.7|8.98||||||||8.98|-19.70|
71917441|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.89|||||TWO_SIDED|95.0|-18.13|8.35||||||||8.35|-18.13|
71917442|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.11|||||TWO_SIDED|95.0|-34.22|-10.01||||||||-10.01|-34.22|
71917443|NCT01263470|143356580|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.27|||||TWO_SIDED|95.0|-35.98|-12.55||||||||-12.55|-35.98|
71917444|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-58.31|||||TWO_SIDED|95.0|-80.79|-35.83||||||||-35.83|-80.79|
71917445|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-60.66|||||TWO_SIDED|95.0|-80.84|-40.47||||||||-40.47|-80.84|
71917446|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-78.72|||||TWO_SIDED|95.0|-97.03|-60.4||||||||-60.40|-97.03|
71917447|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-87.43|||||TWO_SIDED|95.0|-106.26|-68.6||||||||-68.60|-106.26|
71917448|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.73|||||TWO_SIDED|95.0|-24.69|19.23||||||||19.23|-24.69|
71917449|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07|||||TWO_SIDED|95.0|-24.85|14.7||||||||14.70|-24.85|
71917450|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.13|||||TWO_SIDED|95.0|-41.16|-5.11||||||||-5.11|-41.16|
71917451|NCT01263470|143356581|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.84|||||TWO_SIDED|95.0|-50.36|-13.33||||||||-13.33|-50.36|
71917452|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.859|||||TWO_SIDED|95.0|-2.736|8.455||||||||8.455|-2.736|
71917453|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.456|||||TWO_SIDED|95.0|0.748|10.165||||||||10.165|0.748|
71917454|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.715|||||TWO_SIDED|95.0|3.181|12.248||||||||12.248|3.181|
71917455|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.557|||||TWO_SIDED|95.0|-3.763|8.877||||||||8.877|-3.763|
71917456|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|||||TWO_SIDED|95.0|7.924|21.396||||||||21.396|7.924|
71917457|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.257|||||TWO_SIDED|95.0|11.353|23.16||||||||23.160|11.353|
71917458|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.515|||||TWO_SIDED|95.0|13.629|25.401||||||||25.401|13.629|
71917459|NCT01263470|143356582|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.357|||||TWO_SIDED|95.0|7.013|21.701||||||||21.701|7.013|
71917460|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.535|||||TWO_SIDED|95.0|-0.019|1.089||||||||1.089|-0.019|
71917461|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|0.214|1.315||||||||1.315|0.214|
71917462|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.999|||||TWO_SIDED|95.0|0.418|1.58||||||||1.580|0.418|
71917463|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.959|||||TWO_SIDED|95.0|0.43|1.489||||||||1.489|0.430|
71876641|NCT04439071|143271863|OTHER|||||||0.033|||||||Log Rank|||Time to respiratory improvement was compared between treatment groups using stratified log-rank test.||||0.033
71876642|NCT00729781|143271935|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|57.8||||0.19|ONE_SIDED|97.5|42.2||||One-sided, binomial exact test|||This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was \< 0.025, the objective would have been met.|||42.2|0.19
71876643|NCT00729781|143271936|SUPERIORITY_OR_OTHER||Percent of subjects with improvement|15.6|||>|0.99|ONE_SIDED|97.5|0.05||||One-sided, binomial exact test||||||0.05|>0.99
71876644|NCT01186796|143271950|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71876645|NCT01186796|143271951|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
71876646|NCT01186796|143271952|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||"Unit of mass secreted per burst is in ug/L. An automated deconvolution method was used and mathematically verified by direct statistical proof and empirically validated using hypothalamopituitary sampling and a simulated pulsatile time series."|ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
71876647|NCT01186796|143271953|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
71876648|NCT01186796|143271954|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.||||||<0.05
71917464|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.934|||||TWO_SIDED|95.0|0.315|1.552||||||||1.552|0.315|
71917465|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.163|||||TWO_SIDED|95.0|0.551|1.774||||||||1.774|0.551|
71917466|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.398|||||TWO_SIDED|95.0|0.759|2.036||||||||2.036|0.759|
71917467|NCT01263470|143356583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.358|||||TWO_SIDED|95.0|0.76|1.956||||||||1.956|0.760|
71917468|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.25|||||TWO_SIDED|95.0|-7.87|16.38||||||||16.38|-7.87|
71917469|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26|||||TWO_SIDED|95.0|-0.9|23.42||||||||23.42|-0.90|
71917470|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-10.56|16.95||||||||16.95|-10.56|
71917471|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|||||TWO_SIDED|95.0|-16.27|8.94||||||||8.94|-16.27|
71917472|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75|||||TWO_SIDED|95.0|-9.79|19.29||||||||19.29|-9.79|
71917473|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.76|||||TWO_SIDED|95.0|-2.67|26.19||||||||26.19|-2.67|
71917474|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69|||||TWO_SIDED|95.0|-12.02|19.4||||||||19.40|-12.02|
71917475|NCT01263470|143356584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.17|||||TWO_SIDED|95.0|-18.04|11.71||||||||11.71|-18.04|
71917476|NCT01058395|143356621|SUPERIORITY|"Comparison between groups at 3 months (primary).~Comparison between the 2 tiers."||||||0.021||||||P-value|ANCOVA|Threshold for significance was P-value \< 0.05||DRS levels changes at from 4 weeks to 3 months comparing the different doses.||||0.021
71917477|NCT01058395|143356621|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 3 months.||||0.258
71917478|NCT01058395|143356621|SUPERIORITY|t-test||||||0.541|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 4 weeks.||||0.541
71917479|NCT01058395|143356623|SUPERIORITY||Mean Difference (Final Values)|176.0|||>|0.05|ONE_SIDED||||||t-test, 2 sided|||||||>0.05
71917480|NCT04083781|143356624|SUPERIORITY|Analyses of count endpoints were analysed using a negative binomial regression model with the logarithm of the length of the observation period included (in years) as an offset with randomised treatment regimen, type of haemophilia (HAwI or HBwI) and bleeding frequency (less than 9 or greater than or equal to 9 bleeding episodes during the past 24 weeks prior to screening) as factors comparing arm 1 (on-demand treatment) and arm 2.|Annualised bleeding rate ratio|0.14|||<|0.001|TWO_SIDED|95.0|0.07|0.29|||Two-sided test of no difference from 1|||||0.29|0.07|<0.001
71876649|NCT01936909|143271969|SUPERIORITY||||||>|0.2|||||||ANOVA|||This test reflects a comparison between baseline and 2 weeks (both rows).||||>0.20
71917481|NCT00557362|143356678|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.29|TWO_SIDED|95.0|-0.28|0.083|||Regression, Linear|Multiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization||||0.083|-0.28|0.29
71917482|NCT00557362|143356679|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.4|TWO_SIDED|95.0|0.76|2.02|||Regression, Cox|||||2.02|0.76|0.40
71917483|NCT00557362|143356680|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.37|TWO_SIDED|95.0|-0.2|0.53|||Regression, Linear|||||0.53|-0.20|0.37
71917484|NCT00557362|143356681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.62|TWO_SIDED|95.0|-0.25|0.41|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.||0.41|-0.25|0.62
71917485|NCT00557362|143356681|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.26|TWO_SIDED|95.0|-0.57|0.17|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.||0.17|-0.57|0.26
71917486|NCT00557362|143356682|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.53|TWO_SIDED|95.0|-0.26|0.14|||Regression, Linear|||||0.14|-0.26|0.53
71917487|NCT06408818|143356707|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.06||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
71917488|NCT06408818|143356708|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.05||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
71917489|NCT06408818|143356709|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.07||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
71917490|NCT06408818|143356710|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.06||0.46|TWO_SIDED||||||Regression, Linear|||||||0.46
71876650|NCT01936909|143271970|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Paired analysis versus baseline||||<0.01
71876651|NCT01936909|143271971|SUPERIORITY|Log-rank test||||||0.12|||||||Log Rank|||||||0.12
71876652|NCT01958788|143271972|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.06|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
71876653|NCT01958788|143271972|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.34|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71917491|NCT06408818|143356711|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.17||0.2|TWO_SIDED||||||Regression, Linear|||||||0.20
71917492|NCT06408818|143356712|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.22|TWO_SIDED||||||Regression, Linear|||||||0.22
71917493|NCT06408818|143356713|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.19||0.48|TWO_SIDED||||||Regression, Linear|||||||0.48
71917494|NCT06408818|143356714|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.69|TWO_SIDED||||||Regression, Linear|||||||0.69
71917495|NCT06408818|143356715|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.63||0.22|TWO_SIDED||||||Regression, Logistic|||||||0.22
71917496|NCT06408818|143356716|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used logistic regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.79||0.57|TWO_SIDED||||||Regression, Logistic|||||||0.57
71917497|NCT06408818|143356717|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1||0.42|TWO_SIDED||||||Regression, Linear|||||||0.42
71917498|NCT06408818|143356718|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED||||||Regression, Linear|||||||0.45
71684637|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.788||||0.0213|TWO_SIDED|95.0|1.091|2.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.932|1.091|0.0213
71876654|NCT01958788|143271972|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876655|NCT01958788|143271973|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.32|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
71876656|NCT01958788|143271973|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.29|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71876657|NCT01958788|143271973|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.15|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876658|NCT01958788|143271974|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.72|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment follow-up||||
71876659|NCT01958788|143271974|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.66|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71876660|NCT01958788|143271974|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.07|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876661|NCT01958788|143271975|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.13|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
71876662|NCT01958788|143271975|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71876663|NCT01958788|143271975|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.18|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876664|NCT01958788|143271976|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.41|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
71876665|NCT01958788|143271976|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.65|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71876666|NCT01958788|143271976|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.7|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876667|NCT01958788|143271977|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.64|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
71876668|NCT01958788|143271977|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.47|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71876669|NCT01958788|143271977|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.56|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876670|NCT01958788|143271978|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08|||||TWO_SIDED||||||Cohen's d effect size|||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment||||
71876671|NCT01958788|143271978|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.15|||||TWO_SIDED||||||Cohen's d effect size|||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up||||
71876672|NCT01958788|143271978|SUPERIORITY_OR_OTHER||Cohen's d effect size|-0.55|||||TWO_SIDED||||||Cohen's d effect size|||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up||||
71876673|NCT00962390|143271979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4678|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4678
71876674|NCT00962390|143271979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.4892|TWO_SIDED|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.1|-0.5|0.4892
71876675|NCT00962390|143271979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.8185|TWO_SIDED|95.0|-0.8|1.0||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect||1.0|-0.8|0.8185
71876676|NCT00744211|143271993|SUPERIORITY_OR_OTHER||||||<|0.05||||||p\<0.05; Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||<0.05
71876677|NCT00744211|143271994|SUPERIORITY_OR_OTHER|||||||0.001||||||Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA|||||||0.001
71876678|NCT00744211|143271995|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71684638|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.0002|TWO_SIDED|95.0|0.856|0.953|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.953|0.856|0.0002
71684639|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.723||||0.0306|TWO_SIDED|95.0|0.538|0.97|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.538|0.0306
71917499|NCT06408818|143356719|EQUIVALENCE|To examine intervention effects on primary outcomes at posttest, we used linear regression in intent-to-treat analyses. Posttest scores were regressed onto pretest scores, covariates, and the treatment effect.|Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.39|TWO_SIDED||||||Regression, Linear|||||||0.39
71917500|NCT02723019|143356763|SUPERIORITY|||||||0.01|||||||Regression, Logistic|||Analyzed using logistic regression analysis||||0.01
71917501|NCT02723019|143356764|SUPERIORITY|||||||0.19|||||||Regression, Logistic|||||||0.19
71917502|NCT02723019|143356765|SUPERIORITY|||||||0.73||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.73
71917503|NCT02723019|143356766|SUPERIORITY|||||||0.28||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.28
71917504|NCT02723019|143356767|SUPERIORITY|||||||0.71||||||P-value is for the time by group interaction effect, testing the difference in rate of change between the Intervention and Control groups from baseline to 6 months post baseline|multilevel model analysis, random interc|||multilevel model analysis, random intercepts and slopes, appropriate link function for outcome, full maximum likelihood estimation||||0.71
71917505|NCT02723019|143356768|SUPERIORITY|||||||0.42|||||||negative binomial regression model analy|||negative binomial regression model analysis||||0.42
71876679|NCT00744211|143271996|EQUIVALENCE|Chi-square tests for differences between groups.||||||0.015||||||P-value is associated with the hematological/lymphatic adverse event.|Chi-squared|||||||0.015
71876680|NCT03740997|143272000|OTHER||Mean Difference (Net)|16.2|STANDARD_DEVIATION|5.46||0.0008|TWO_SIDED|95.0|10.44|21.89|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||21.89|10.44|0.0008
71876681|NCT03740997|143272000|OTHER||Mean Difference (Net)|17.1|STANDARD_DEVIATION|13.49|<|0.0001|TWO_SIDED|95.0|11.11|23.07|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 1||23.07|11.11|<0.0001
71876682|NCT03740997|143272000|OTHER||Mean Difference (Net)|19.3|STANDARD_DEVIATION|6.5||0.0002|TWO_SIDED|95.0|13.28|25.3|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||25.30|13.28|0.0002
71876683|NCT03740997|143272000|OTHER||Mean Difference (Net)|18.5|STANDARD_DEVIATION|11.68|<|0.0001|TWO_SIDED|95.0|13.47|23.57|||Paired t-test|||Reader 1: Difference Between Non-contrast and OPTISON Dose Level 2||23.57|13.47|<0.0001
71876684|NCT03740997|143272000|OTHER||Mean Difference (Net)|19.8|STANDARD_DEVIATION|3.06|<|0.0001|TWO_SIDED|95.0|16.62|23.05|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||23.05|16.62|<0.0001
71876685|NCT03740997|143272000|OTHER||Mean Difference (Net)|20.1|STANDARD_DEVIATION|13.38|<|0.0001|TWO_SIDED|95.0|14.16|26.03|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 1||26.03|14.16|<0.0001
71876686|NCT03740997|143272000|OTHER||Mean Difference (Net)|22.0|STANDARD_DEVIATION|2.77|<|0.0001|TWO_SIDED|95.0|19.44|24.56|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||24.56|19.44|<0.0001
71876687|NCT03740997|143272000|OTHER||Mean Difference (Net)|21.2|STANDARD_DEVIATION|13.34|<|0.0001|TWO_SIDED|95.0|15.45|26.99|||Paired t-test|||Reader 2: Difference Between Non-contrast and OPTISON Dose Level 2||26.99|15.45|<0.0001
71876688|NCT03740997|143272000|OTHER||Mean Difference (Net)|11.8|STANDARD_DEVIATION|9.35||0.0268|TWO_SIDED|95.0|2.02|21.64|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||21.64|2.02|0.0268
71876689|NCT03740997|143272000|OTHER||Mean Difference (Net)|16.1|STANDARD_DEVIATION|15.08|<|0.0001|TWO_SIDED|95.0|9.45|22.82|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 1||22.82|9.45|<0.0001
71876690|NCT03740997|143272000|OTHER||Mean Difference (Net)|12.1|STANDARD_DEVIATION|6.59||0.0028|TWO_SIDED|95.0|6.04|18.24|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||18.24|6.04|0.0028
71876691|NCT03740997|143272000|OTHER||Mean Difference (Net)|15.8|STANDARD_DEVIATION|13.37|<|0.0001|TWO_SIDED|95.0|10.04|21.61|||Paired t-test|||Reader 3: Difference Between Non-contrast and OPTISON Dose Level 2||21.61|10.04|<0.0001
71684640|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.145||||0.0005|TWO_SIDED|95.0|1.061|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.061|0.0005
71876692|NCT01026142|143272013|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.0731|TWO_SIDED|95.0|0.65|1.02||The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.|Log Rank|Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.|The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.|"The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:~H0: IRF PFS\<pertuzumab\> = IRF PFS\<control\> vs. H1: IRF PFS\<pertuzumab\> ≠ IRF PFS\<control\>"||1.02|0.65|0.0731
71876693|NCT01829425|143272022|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney|Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.|Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds \> - 5% would be consistent with non-inferiority||||5|<.025
71876694|NCT01829425|143272023|NON_INFERIORITY|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If|Difference in median % change between gr|5.0|||<|0.025|ONE_SIDED|95.0|5.0||||Exact Mann Whitney||||||5|<.025
71876695|NCT04178967|143272034|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
71876696|NCT04178967|143272035|SUPERIORITY||Risk Difference (RD)|33.3|||<|1e-06|TWO_SIDED|95.0|24.4|42.2|||Cochran-Mantel-Haenszel|||||42.2|24.4|<0.000001
71876697|NCT04178967|143272036|SUPERIORITY||Risk Difference (RD)|0.7||||0.308463|TWO_SIDED|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel|||||1.7|-0.3|0.308463
71876698|NCT04178967|143272037|SUPERIORITY||Risk Difference (RD)|8.1||||0.001607|TWO_SIDED|95.0|4.1|12.0|||Cochran-Mantel-Haenszel|||||12.0|4.1|0.001607
71876699|NCT04178967|143272038|SUPERIORITY||Risk Difference (RD)|21.9||||4e-06|TWO_SIDED|95.0|14.2|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.2|0.000004
71876700|NCT04178967|143272039|SUPERIORITY||Risk Difference (RD)|20.7||||8e-06|TWO_SIDED|95.0|13.3|28.1|||Cochran-Mantel-Haenszel|||||28.1|13.3|0.000008
71876701|NCT04178967|143272040|SUPERIORITY||LS Mean Difference (Final Values)|-27.53|||<|1e-06|TWO_SIDED|95.0|-34.9|-20.2|||ANCOVA|||||-20.2|-34.9|<0.000001
71876702|NCT04178967|143272041|SUPERIORITY||Risk Difference (RD)|28.3|||<|1e-06|TWO_SIDED|95.0|20.0|36.5|||Cochran-Mantel-Haenszel|||||36.5|20.0|<0.000001
71876703|NCT04178967|143272042|SUPERIORITY||Risk Difference (RD)|29.7|||<|1e-06|TWO_SIDED|95.0|21.0|38.4|||Cochran-Mantel-Haenszel|||||38.4|21.0|<0.000001
71876704|NCT04178967|143272043|SUPERIORITY||LS Mean Difference (Final Values)|-33.57|||<|1e-06|TWO_SIDED|95.0|-41.2|-26.0|||ANCOVA|||||-26.0|-41.2|<0.000001
71876705|NCT04178967|143272044|SUPERIORITY||LS Mean Difference (Final Values)|-16.2|||<|1e-06|TWO_SIDED|95.0|-20.3|-12.0|||Mixed Models Analysis|||||-12.0|-20.3|<0.000001
71876706|NCT04178967|143272045|SUPERIORITY||Risk Difference (RD)|4.9||||0.022921|TWO_SIDED|95.0|1.4|8.4|||Cochran-Mantel-Haenszel|||||8.4|1.4|0.022921
71876707|NCT04178967|143272046|SUPERIORITY||LS Mean Difference (Final Values)|-4.9|||<|1e-06|TWO_SIDED|95.0|-6.3|-3.5|||ANCOVA|||||-3.5|-6.3|<0.000001
71876708|NCT04178967|143272047|SUPERIORITY||Risk Difference (RD)|32.9||||1e-06|TWO_SIDED|95.0|22.2|43.6|||Cochran-Mantel-Haenszel|||||43.6|22.2|0.000001
71876709|NCT04178967|143272048|SUPERIORITY||Risk Difference (RD)|33.0||||1e-06|TWO_SIDED|95.0|22.2|43.8|||Cochran-Mantel-Haenszel|||||43.8|22.2|0.000001
71876710|NCT04178967|143272049|SUPERIORITY||LS Mean Difference (Final Values)|-37.09|||<|1e-06|TWO_SIDED|95.0|-47.4|-26.8|||ANCOVA|||||-26.8|-47.4|<0.000001
71876711|NCT04178967|143272050|SUPERIORITY||LS Mean Difference (Final Values)|-0.7|||<|1e-06|TWO_SIDED|95.0|-0.9|-0.5|||ANCOVA|||||-0.5|-0.9|<0.000001
71876712|NCT04178967|143272051|SUPERIORITY||Risk Difference (RD)|18.9||||0.000571|TWO_SIDED|95.0|9.6|28.1|||Cochran-Mantel-Haenszel|||||28.1|9.6|0.000571
71876713|NCT04178967|143272052|SUPERIORITY||Risk Difference (RD)|0.4||||0.469221|TWO_SIDED|95.0|-0.4|1.2|||Cochran-Mantel-Haenszel|||||1.2|-0.4|0.469221
71876714|NCT04178967|143272053|SUPERIORITY||Risk Difference (RD)|2.7||||0.113194|TWO_SIDED|95.0|-0.1|5.4|||Cochran-Mantel-Haenszel|||||5.4|-0.1|0.113194
71876715|NCT04178967|143272054|SUPERIORITY||Risk Difference (RD)|13.2||||0.00023|TWO_SIDED|95.0|7.7|18.7|||Cochran-Mantel-Haenszel|||||18.7|7.7|0.000230
71876716|NCT04178967|143272055|SUPERIORITY||Risk Difference (RD)|0.4||||0.46816|TWO_SIDED|95.0|-0.4|1.3|||Cochran-Mantel-Haenszel|||||1.3|-0.4|0.468160
71876717|NCT04178967|143272056|SUPERIORITY||Risk Difference (RD)|2.9||||0.11577|TWO_SIDED|95.0|-0.1|5.8|||Cochran-Mantel-Haenszel|||||5.8|-0.1|0.115770
71876718|NCT04178967|143272057|SUPERIORITY||Risk Difference (RD)|14.2||||0.000252|TWO_SIDED|95.0|8.2|20.1|||Cochran-Mantel-Haenszel|||||20.1|8.2|0.000252
71876719|NCT04178967|143272058|SUPERIORITY||LS Mean Difference (Final Values)|-30.76|||<|1e-06|TWO_SIDED|95.0|-36.93|-24.59|||ANCOVA|||||-24.59|-36.93|<0.000001
71876720|NCT04178967|143272060|SUPERIORITY||Risk Difference (RD)|12.8||||0.238245|TWO_SIDED|95.0|-9.5|35.1|||Cochran-Mantel-Haenszel|||||35.1|-9.5|0.238245
71876721|NCT04178967|143272060|SUPERIORITY||Risk Difference (RD)|4.8||||0.612427|TWO_SIDED|95.0|-17.8|27.3|||Cochran-Mantel-Haenszel|||||27.3|-17.8|0.612427
71876722|NCT04178967|143272061|SUPERIORITY||Risk Difference (RD)|32.6||||0.033876|TWO_SIDED|95.0|2.6|62.5|||Cochran-Mantel-Haenszel|||||62.5|2.6|0.033876
71876723|NCT04178967|143272061|SUPERIORITY||Risk Difference (RD)|13.4||||0.407417|TWO_SIDED|95.0|-17.5|44.3|||Cochran-Mantel-Haenszel|||||44.3|-17.5|0.407417
71917506|NCT00515099|143356795|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.60
71917507|NCT00515099|143356796|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL||||0.40
71917508|NCT00515099|143356797|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 12||||0.59
71917509|NCT00515099|143356797|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 24||||0.14
71917510|NCT00515099|143356799|SUPERIORITY_OR_OTHER||||||>|0.099|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 12||||>0.099
71917511|NCT00515099|143356799|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 24||||0.75
71917512|NCT00515099|143356800|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.38
71917513|NCT00515099|143356800|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.33
71917514|NCT00515099|143356801|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 12||||0.07
71917515|NCT00515099|143356801|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 24||||0.16
71917516|NCT03676465|143356813|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917517|NCT03676465|143356814|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917518|NCT03676465|143356815|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917519|NCT03676465|143356816|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917520|NCT03676465|143356817|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71917521|NCT03676465|143356818|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917522|NCT03676465|143356819|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71917523|NCT03676465|143356820|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917524|NCT03676465|143356821|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917525|NCT03676465|143356822|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
71917526|NCT03676465|143356823|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|t-test, 2 sided|||||||>0.05
71917527|NCT03676465|143356824|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
71917528|NCT03676465|143356825|SUPERIORITY||||||>|0.05||||||Calculated p value was \>0.05|Wilcoxon (Mann-Whitney)|||||||>0.05
71917529|NCT03676465|143356826|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71917530|NCT03685643|143356827|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71917531|NCT03685643|143356828|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71917532|NCT03685643|143356829|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71917533|NCT02268942|143356837|OTHER|||||||0.0003|||||||Exact Binomial|||"Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%."||||0.0003
71684641|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.907||||0.0122|TWO_SIDED|95.0|1.151|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.158|1.151|0.0122
71684642|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.175||||0.0956|TWO_SIDED|95.0|0.872|5.424|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.424|0.872|0.0956
71684643|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.267||||0.0846|TWO_SIDED|95.0|0.06|1.197|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.197|0.060|0.0846
71684644|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.897|||<|0.0001|TWO_SIDED|95.0|0.852|0.945|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.945|0.852|<0.0001
71684645|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
71876724|NCT04178967|143272062|SUPERIORITY||Risk Difference (RD)|20.3||||0.159281|TWO_SIDED|95.0|-11.4|52.0|||Cochran-Mantel-Haenszel|||||52.0|-11.4|0.159281
71876725|NCT04178967|143272062|SUPERIORITY||Risk Difference (RD)|20.4||||0.16495|TWO_SIDED|95.0|-10.6|51.4|||Cochran-Mantel-Haenszel|||||51.4|-10.6|0.164950
71876726|NCT04178967|143272063|SUPERIORITY||Risk Difference (RD)|19.7||||0.179704|TWO_SIDED|95.0|-12.2|51.2|||Cochran-Mantel-Haenszel|||||51.2|-12.2|0.179704
71876727|NCT04178967|143272063|SUPERIORITY||Risk Difference (RD)|24.3||||0.08308|TWO_SIDED|95.0|-6.5|55.1|||Cochran-Mantel-Haenszel|||||55.1|-6.5|0.083080
71876728|NCT04178967|143272064|SUPERIORITY||LS Mean Difference (Final Values)|-6.29||||0.176748|TWO_SIDED|95.0|-15.46|2.87|||ANCOVA|||||2.87|-15.46|0.176748
71876729|NCT04178967|143272064|SUPERIORITY||LS Mean Difference (Final Values)|-6.25||||0.183151|TWO_SIDED|95.0|-15.48|2.99|||ANCOVA|||||2.99|-15.48|0.183151
71876730|NCT04178967|143272065|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.1|0.1|||ANCOVA|||UK||0.1|0.1|0.000001
71876731|NCT04178967|143272065|SUPERIORITY||LS Mean Difference (Final Values)|0.1||||1e-06|TWO_SIDED|95.0|0.0|0.1|||ANCOVA|||US||0.1|0.0|0.000001
71876732|NCT04178967|143272066|SUPERIORITY||LS Mean Difference (Final Values)|4.5||||0.005304|TWO_SIDED|95.0|1.3|7.6|||ANCOVA|||||7.6|1.3|0.005304
71876733|NCT04178967|143272067|SUPERIORITY||LS Mean Difference (Final Values)|-6.0|||<|1e-06|TWO_SIDED|95.0|-7.7|-4.3|||Mixed Models Analysis|||||-4.3|-7.7|<0.000001
71876734|NCT04178967|143272068|SUPERIORITY||LS Mean Difference (Final Values)|-2.91||||0.241275|TWO_SIDED|95.0|-7.85|2.03|||ANCOVA|||||2.03|-7.85|0.241275
71876735|NCT04178967|143272069|SUPERIORITY||LS Mean Difference (Final Values)|-2.74||||0.000116|TWO_SIDED|95.0|-4.12|-1.36|||ANCOVA|||||-1.36|-4.12|0.000116
71876736|NCT04178967|143272070|SUPERIORITY||LS Mean Difference (Final Values)|-1.1||||0.645132|TWO_SIDED|95.0|-5.86|3.67|||ANCOVA|||||3.67|-5.86|0.645132
71876737|NCT04178967|143272071|SUPERIORITY||LS Mean Difference (Final Values)|-2.75||||3.1e-05|TWO_SIDED|95.0|-4.03|-1.47|||ANCOVA|||||-1.47|-4.03|0.000031
71876738|NCT04178967|143272072|SUPERIORITY||LS Mean Difference (Final Values)|0.0||||0.974417|TWO_SIDED|95.0|-0.27|0.26|||ANCOVA|||||0.26|-0.27|0.974417
71876739|NCT04178967|143272073|SUPERIORITY||LS Mean Difference (Final Values)|-4.2||||0.084769|TWO_SIDED|95.0|-9.1|0.6|||Mixed Models Analysis|||||0.6|-9.1|0.084769
71876740|NCT00628251|143272170|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.6604|TWO_SIDED|95.0|0.51|1.56||If the observed p-value for the combined olaparib groups is \<0.02 (1-sided) then the result will be regarded as statistically significant.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.56|0.51|0.6604
71876741|NCT00628251|143272170|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.7794||95.0|0.48|1.74||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.74|0.48|0.7794
71876742|NCT00628251|143272170|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.6604|TWO_SIDED|95.0|0.45|1.62||An observed p-value of \<0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio \< 1 favours olaparib.||1.62|0.45|0.6604
71876743|NCT00628251|143272171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.27||||0.1291|TWO_SIDED|95.0|0.79|7.32||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||7.32|0.79|0.1291
71917534|NCT02268942|143356838|OTHER||||||<|0.0001|||||||t-test, 1 sided|||"The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients."||||<0.0001
71917535|NCT00572728|143356852|SUPERIORITY_OR_OTHER||AUC|0.68|STANDARD_ERROR_OF_MEAN|0.1||0.046|ONE_SIDED|95.0||0.83||The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one-sided p value DeLong ER, DeLong DM, Clarke-Pearson DL, Biometrics (1988)|Delong method|one-sided p-value|"percent change in SUVmax was computed as: %ΔSUVmax = 100\*(FLT1-FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.~Hanley SE(AUC) reported."|"A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC \>= 0.75 AUC = ROC(%ΔSUVmax\| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 -SUVmax at FLT2)/SUVmax at FLT1 x 100"||.83||0.046
71917536|NCT00572728|143356853|SUPERIORITY_OR_OTHER||spearman correlation|0.35||||0.002|TWO_SIDED|95.0|0.13|0.54|||spearman correlation method||This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic||0.54|0.13|0.002
71917537|NCT00572728|143356854|SUPERIORITY_OR_OTHER||Spearman Correlation|0.67|||<|0.0001|TWO_SIDED|95.0|0.47|0.81|||Spearman Correlation method|we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI||0.81|0.47|<0.0001
71917538|NCT00572728|143356855|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||"H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups.."||||0.66
71917539|NCT00572728|143356856|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|\*two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.||||0.86
71917540|NCT00572728|143356857|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-sided exact p value from Wilcoxon two-sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.||||0.010
71684646|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
71917541|NCT00572728|143356857|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.013|TWO_SIDED|95.0|0.76|0.97|||Regression, Logistic|||H0: %SUVmax FLT1-FLT3 (RCB 0,I) = %SUVmax FLT1-FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.||0.97|0.76|0.013
71917542|NCT00572728|143356858|SUPERIORITY_OR_OTHER||AUC|0.83|||<|0.001|TWO_SIDED|90.0|0.72|0.94||Delong 1-sided p-value (alpha=0.05)|Delong Method|The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC||"ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1-FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1-FLT3\|pCR)= 1 - P(%ΔSUVmax FLT1-FLT3\|non-pCR) that is: H0: AUC =0.5 (guessing)"||.94|.72|<0.001
71917543|NCT00572728|143356859|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED||||||Kruskal-Wallis|two-sided p value from Kruskal-Wallis one-way ANOVA||"Kruskal-Wallis one-way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status."||||0.86
71917544|NCT00572728|143356860|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED|||||two-sided p value from Kruskal-Wallis one-way ANOVA|Kruskal-Wallis|||||||0.67
71917545|NCT00113555|143356868|SUPERIORITY||Mean Difference (Net)|-1.16|STANDARD_DEVIATION|1.05|<|0.001|TWO_SIDED|95.0|-1.325|-1.003|||Wilcoxon (Mann-Whitney)|||Wilcoxon's matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.||-1.003|-1.325|<0.001
71917546|NCT03398824|143356880|OTHER|Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \< 20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|response rate|30.8|||||TWO_SIDED|90.0|11.3|57.3|||||||Fanconi Anemia is a rare disease. Therefore, the primary end point of the study was to assess the proportion of subjects with a HR during 6 months of metformin treatment; sample size was calculated assuming that a HR rate \>20% suggests preliminary efficacy of treatment that warranted additional investigation and, conversely, that the study should be deemed futile if the rate of HR was \<5%.|57.3|11.3|
71917547|NCT04337203|143356901|OTHER|Feasibility study and calculated confidence interval.||||||0.54|||||||Independent samples proportions test|||||||0.54
71917548|NCT04191096|143356927|OTHER||Hazard Ratio (HR)|1.2||||0.9467|TWO_SIDED|95.0|0.96|1.49||A one-sided p-value was calculated using the log-rank test stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.49|0.96|0.9467
71917549|NCT04191096|143356928|OTHER||Hazard Ratio (HR)|1.16||||0.85122|TWO_SIDED|95.0|0.88|1.53||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.53|0.88|0.85122
71917550|NCT04191096|143356929|OTHER||Hazard Ratio (HR)|1.24||||0.97907|TWO_SIDED|95.0|1.01|1.54||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.54|1.01|0.97907
71917551|NCT04191096|143356930|OTHER||Hazard Ratio (HR)|0.89||||0.27202|TWO_SIDED|95.0|0.61|1.3||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.30|0.61|0.27202
71917552|NCT04191096|143356931|OTHER||Hazard Ratio (HR)|0.92||||0.2972|TWO_SIDED|95.0|0.69|1.23||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.23|0.69|0.2972
71917553|NCT04191096|143356932|OTHER||Hazard Ratio (HR)|1.07||||0.6863|TWO_SIDED|95.0|0.81|1.41||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.41|0.81|0.6863
71917554|NCT04191096|143356933|OTHER||Hazard Ratio (HR)|1.15||||0.9235|TWO_SIDED|95.0|0.95|1.39||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||1.39|0.95|0.9235
71917555|NCT04191096|143356934|OTHER||Hazard Ratio (HR)|1.16||||0.8801|TWO_SIDED|95.0|0.9|1.5||One-sided p-value based on log-rank test stratified by prior docetaxel for mHSPC (Yes vs No) and presence of high-volume disease (Yes vs No) with small strata.|Log Rank||HR and associated 95% Confidence Interval (CI) were calculated using Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||1.50|0.90|0.8801
71917556|NCT04191096|143356935|OTHER||Percent Difference|-2.7||||0.9576|TWO_SIDED|95.0|-5.8|0.4||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen method||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No).|||0.4|-5.8|0.9576
71876744|NCT00628251|143272171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.3131|TWO_SIDED|95.0|0.55|7.01||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||7.01|0.55|0.3131
71876745|NCT00628251|143272171|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.69||||0.1079|TWO_SIDED|95.0|0.81|9.76|||Regression, Logistic|The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio \>1 favoured olaparib|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||9.76|0.81|0.1079
71876746|NCT00628251|143272177|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.5781|TWO_SIDED|95.0|0.41|1.7||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).||1.70|0.41|0.5781
71876747|NCT00628251|143272177|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.3417|TWO_SIDED|95.0|0.27|1.55||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).||1.55|0.27|0.3417
71876748|NCT00628251|143272177|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.01||||0.9877|TWO_SIDED|95.0|0.44|2.27||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of \<1 favoured olaparib.|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).||2.27|0.44|0.9877
71876749|NCT03684642|143272216|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was \<=0.3%.|Least Square (LS) Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.2|0.14||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.14|-0.20|
71876750|NCT03684642|143272216|NON_INFERIORITY|Non-inferiority of Efpeglenatide vs. Dulaglutide was demonstrated if the upper bound of the two-sided 95% CI for the difference between groups was \<=0.3%.|LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.25|0.09||||||A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using ANCOVA model with the treatment groups, randomization strata, and geographical region as fixed classification effects, and baseline HbA1c value as a continuous covariate.||0.09|-0.25|
71876751|NCT03684642|143272216|SUPERIORITY|||||||0.7064||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.7064
71876752|NCT03684642|143272216|SUPERIORITY|||||||0.3427||||||Threshold for significance at the level of 0.05.|ANCOVA|||||||0.3427
71876753|NCT04556396|143272229|SUPERIORITY||Odds Ratio (OR)|0.2|||<|0.01|TWO_SIDED|95.0|0.1|0.4|||Chi-squared|||||0.4|0.1|<0.01
71917557|NCT04191096|143356936|OTHER||Percent difference|-0.8||||0.6053|TWO_SIDED|95.0|-6.3|4.8||One-sided p-value based on Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docetaxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||4.8|-6.3|0.6053
71917558|NCT04191096|143356937|OTHER||Percent difference|-5.6||||0.9105|TWO_SIDED|95.0|-13.7|2.6||One-sided p-value based on Miettinen \& Nurminen method stratified prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No) with small strata.|Miettinen & Nurminen||Percent difference and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by prior docataxel for mHSPC (Yes/No) and presence of high-volume disease (Yes/No)|||2.6|-13.7|0.9105
71917559|NCT00908895|143356980|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|70.0|STANDARD_DEVIATION|25.0|<|0.05||95.0|||||Chi-squared|||We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.||||<0.05
71876754|NCT02374021|143272291|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|95.0|-0.19|0.15|||ANCOVA|||||0.15|-0.19|0.79
71876755|NCT02374021|143272292|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.05|TWO_SIDED|95.0|-0.14|0.17|||ANCOVA|||||0.17|-0.14|0.05
71876756|NCT02374021|143272293|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.05|TWO_SIDED|95.0|-0.11|0.18|||ANCOVA|||||0.18|-0.11|0.05
71876757|NCT02374021|143272294|SUPERIORITY||Mean Difference (Final Values)|-0.003||||0.05|TWO_SIDED|95.0|-0.2|0.19|||ANCOVA|||||0.19|-0.20|0.05
71876758|NCT02374021|143272295|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.05|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|||||0.16|-0.17|0.05
71876759|NCT01667107|143272300|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.53||||0.139|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.139
71876760|NCT01667107|143272300|SUPERIORITY_OR_OTHER||Spearman rank correlation coefficient|0.59||||0.057|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations||||0.057
71876761|NCT01162239|143272327|OTHER|||||||0.62|||||||Chi-squared|||||||0.62
71876762|NCT01162239|143272328|OTHER|||||||0.91|||||||Chi-squared|||||||0.91
71876763|NCT00228566|143272329|SUPERIORITY_OR_OTHER||% Responders = 201/241|83.4||||||95.0|78.7|88.1|||Descriptive Statistics||The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.|This was an open label study, with all patients receiving treatment with armodafinil||88.1|78.7|
71917560|NCT00908895|143356981|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|90.0|STANDARD_DEVIATION|10.0|<|0.05||95.0|80.0|100.0|||Chi-squared|||||100|80|<0.05
71917561|NCT00416572|143356996|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||> 0.05
71917562|NCT00416572|143356996|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71684647|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
71917563|NCT00416572|143356996|SUPERIORITY_OR_OTHER||standardized beta|-0.12|||=|0.08|TWO_SIDED||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.08
71917564|NCT00416572|143356996|SUPERIORITY_OR_OTHER||standardized beta|-0.23|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
71917565|NCT00416572|143356997|SUPERIORITY_OR_OTHER||||||>|0.5|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.50
71917566|NCT00416572|143356997|SUPERIORITY_OR_OTHER||Standardized beta|0.14|||=|0.04|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.04
71917567|NCT00416572|143356997|SUPERIORITY_OR_OTHER||Standardized beta|0.25|||<|0.001|TWO_SIDED||||||Regression, Linear|||Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||<0.001
71917568|NCT00416572|143356997|SUPERIORITY_OR_OTHER||Standardized beta|0.15|||=|0.02|TWO_SIDED||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||=0.02
71917569|NCT00416572|143356998|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome||||>.05
71684648|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
71917570|NCT00416572|143356998|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71917571|NCT00416572|143356998|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71917572|NCT00416572|143356998|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.||||>0.05
71917573|NCT01654224|143356999|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.005||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.005
71917574|NCT01654224|143356999|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.001||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.001
71917575|NCT01654224|143356999|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.004||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.004
71684649|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
71917576|NCT01654224|143356999|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.672||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.672
71917577|NCT01654224|143356999|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.011||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.011
71917578|NCT01654224|143356999|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.01||||||B/Texas/6/2011|t-test, 2 sided|||||||.010
71917579|NCT01654224|143357000|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.074||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.074
71917580|NCT01654224|143357000|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.006||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.006
71917581|NCT01654224|143357000|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.069||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.069
71917582|NCT01654224|143357000|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.663||||||A/California/07/2009(H3N2)|t-test, 2 sided|||||||.663
71917583|NCT01654224|143357000|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.003||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided|||||||.003
71684650|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.996||||0.0033|TWO_SIDED|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.165|1.259|0.0033
71917584|NCT01654224|143357000|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.063||||||B/Texas/6/2011|t-test, 2 sided|||||||.063
71917585|NCT01654224|143357001|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.917||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.917
71917586|NCT01654224|143357001|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.36||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided|||||||.360
71917587|NCT01654224|143357001|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.248||||||B/Brisbane/60/2008|t-test, 2 sided|||||||.248
71917588|NCT01654224|143357001|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.178||||||A/California/07/2009(H1N1)|t-test, 2 sided|||||||.178
71917589|NCT01654224|143357001|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.152||||||A/Victoria/361/2011(H1N2)|t-test, 2 sided|||||||.152
71917590|NCT01654224|143357001|NON_INFERIORITY_OR_EQUIVALENCE|An upper bound \>0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.285||||||B/Texas/6/2011|t-test, 2 sided|||||||.285
71917591|NCT00166504|143357002|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-10.0|STANDARD_DEVIATION|15.3|<|0.001||95.0|-14.3|-5.7|||ANOVA||Direction of the Comparison: Vytorin minus Atorvastatin.|||-5.7|-14.3|<0.001
71922330|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccine Group Differences at Day 86|14.0|||||TWO_SIDED|97.5|1.4|26.7|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW||26.7|1.4|
71922331|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y|Vaccine Group differences at Day 86|27.0|||||TWO_SIDED|97.5|15.6|37.6|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY||37.6|15.6|
71917592|NCT03345849|143357010|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and European Union/European Medicines Agency regulatory purposes.|Adjusted Response Rate Difference|20.8|||<|0.0001|TWO_SIDED|95.0|12.7|28.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|Comparison of the upadacitinib group and placebo group was performed using the Cochran Mantel-Haenszel (CMH) test adjusting for stratification factors (baseline steroid use \[Yes, No\], endoscopic disease severity \[SES-CD \< 15, ≥ 15\] and number of prior biologics with prior inadequate response or intolerance \[0, 1, \> 1\]).||28.8|12.7|<0.0001
71917593|NCT03345849|143357011|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|28.7|||<|0.0001|TWO_SIDED|95.0|20.9|36.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||36.4|20.9|<0.0001
71917594|NCT03345849|143357012|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|33.0|||<|0.0001|TWO_SIDED|95.0|26.2|39.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||39.9|26.2|<0.0001
71917595|NCT03345849|143357013|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.8|||<|0.0001|TWO_SIDED|95.0|15.8|27.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||27.8|15.8|<0.0001
71917596|NCT03345849|143357014|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|27.7|||<|0.0001|TWO_SIDED|95.0|15.7|39.8|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors endoscopic disease severity and number of prior failed biologic therapies.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors endoscopic disease severity and number of prior biologic failed.|||39.8|15.7|<0.0001
71684651|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0095|TWO_SIDED|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.277|1.035|0.0095
71684652|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.155||||0.0031|TWO_SIDED|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.533|0.045|0.0031
71917597|NCT03345849|143357015|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Least Squares (LS) Mean Difference|6.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.0001|TWO_SIDED|95.0|4.2|8.3|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||8.3|4.2|<0.0001
71684653|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.364||||0.0645|TWO_SIDED|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.063|0.125|0.0645
71917598|NCT03345849|143357016|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|LS Mean Difference|21.842|STANDARD_ERROR_OF_MEAN|3.1933|<|0.0001|TWO_SIDED|95.0|15.566|28.118|||Mixed-effect Model Repeated Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, stratification factors, and Baseline value as covariate.||||28.118|15.566|<0.0001
71876764|NCT00232141|143272348|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.29||0.3914||95.0|-0.83|0.32||The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.|ANCOVA|||Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment \& placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, \& a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint||0.32|-0.83|0.3914
71917599|NCT03345849|143357017|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|11.7||||0.0022|TWO_SIDED|95.0|4.2|19.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.2|4.2|0.0022
71876765|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.18||0.0131||95.0|-0.81|-0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.10|-0.81|0.0131
71876766|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.24||0.0393||95.0|-0.96|-0.02||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.02|-0.96|0.0393
71876767|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0554||95.0|-1.08|0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||0.01|-1.08|0.0554
71876768|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.29||0.1513||95.0|-0.99|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.15|-0.99|0.1513
71876769|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.3||0.3345||95.0|-0.89|0.3||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.30|-0.89|0.3345
71876770|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.31||0.0879||95.0|-1.13|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.08|-1.13|0.0879
71876771|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.32||0.0307||95.0|-1.32|-0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.07|-1.32|0.0307
71876772|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.31||0.0156||95.0|-1.36|-0.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.14|-1.36|0.0156
71876773|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.32||0.0981||95.0|-1.15|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.15|0.0981
71917600|NCT03345849|143357018|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|19.8|||<|0.0001|TWO_SIDED|95.0|11.3|28.4|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.4|11.3|<0.0001
71917601|NCT03345849|143357019|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for US/FDA regulatory purposes.|Adjusted Response Rate Difference|10.8||||0.0071|TWO_SIDED|95.0|2.9|18.6|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||18.6|2.9|0.0071
71917602|NCT03345849|143357020|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Response Rate Difference|-1.4||||0.4494|TWO_SIDED|95.0|-5.2|2.4|||Chi-squared||Response rate difference = Upadacitinib - Placebo|||2.4|-5.2|0.4494
71917603|NCT03345849|143357021|OTHER|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints, defined separately for US/FDA and EU/EMA regulatory purposes.|Adjusted Response Rate Difference|9.0||||0.1044|TWO_SIDED|95.0|-1.9|19.9|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||19.9|-1.9|0.1044
71917604|NCT03345849|143357022|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|21.2|||<|0.0001|TWO_SIDED|95.0|14.3|28.2|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||28.2|14.3|<0.0001
71917605|NCT03345849|143357023|SUPERIORITY|The overall type I error rate of the co-primary and ranked secondary endpoints were strongly controlled using a fixed sequence multiple-testing procedure as well as a Holm procedure. The testing utilized the sequence of hypothesis testing for the co-primary endpoints using two-sided α of 0.05 followed by a set of ranked key secondary endpoints. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Adjusted Response Rate Difference|32.6|||<|0.0001|TWO_SIDED|95.0|21.5|43.7|||Cochran-Mantel-Haenszel|Cochran Mantel-Haenszel test adjusted for stratification factors.|Adjusted response rate difference (Upadacitinib - Placebo) calculated based on CMH test adjusted for stratification factors.|||43.7|21.5|<0.0001
71917606|NCT02943577|143357046|SUPERIORITY||Least Squares Mean Difference|-1.0||||0.2398|TWO_SIDED|95.0|-2.7|0.68|||Mixed Model Repeated Measures (MMRM)|||||0.68|-2.70|0.2398
71876774|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.31||0.306||95.0|-0.93|0.29||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.29|-0.93|0.3060
71876775|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.33||0.1874||95.0|-1.08|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.21|-1.08|0.1874
71876776|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.34||0.1025||95.0|-1.22|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.11|-1.22|0.1025
71684654|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.895||||0.0001|TWO_SIDED|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.948|0.846|0.0001
71684655|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.266||||0.0182|TWO_SIDED|95.0|1.041|1.541|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.541|1.041|0.0182
71876777|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.34||0.0662||95.0|-1.3|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||0.04|-1.30|0.0662
71876778|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.37||0.1856||95.0|-1.21|0.24||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.24|-1.21|0.1856
71876779|NCT00232141|143272349|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.7925||95.0|-0.66|0.5||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.50|-0.66|0.7925
71876780|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.18||||0.1191||95.0|0.802|5.935||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||5.935|0.802|0.1191
71876781|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.24||||0.5041||95.0|0.666|2.301||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||2.301|0.666|0.5041
71917607|NCT02943577|143357047|SUPERIORITY||Least Squares Mean Difference|0.4||||0.5522|TWO_SIDED|95.0|-0.95|1.77|||Mixed Model Repeated Measures (MMRM)|||||1.77|-0.95|0.5522
71917608|NCT02943577|143357048|SUPERIORITY||Least Squares Mean Difference|0.0||||0.9901|TWO_SIDED|95.0|-2.01|1.99|||Mixed Model Repeated Measures (MMRM)|||||1.99|-2.01|0.9901
71917609|NCT02943577|143357049|SUPERIORITY||Least Squares Mean Difference|0.5||||0.5563|TWO_SIDED|95.0|-1.17|2.17|||Mixed Model Repeated Measures (MMRM)|||||2.17|-1.17|0.5563
71917610|NCT01355224|143357050|SUPERIORITY_OR_OTHER|||||||0.015|||||||Regression, Linear|Adjusted for age, gender, BMI, baseline intention.||||||.0150
71917611|NCT01355224|143357051|SUPERIORITY_OR_OTHER|||||||0.0365|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0365
71917612|NCT01355224|143357052|SUPERIORITY_OR_OTHER|||||||0.0622|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.||||||0.0622
71917613|NCT04654468|143357058|SUPERIORITY||||||<|0.0001|||||||Paired McNemar|||Percentage of participants who achieved TA from baseline through Week 25 were compared with the percentage of participants who reported TA within 24 weeks prior to screening.||||<.0001
71917614|NCT01099761|143357321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED||||||ANCOVA|||||||0.023
71917615|NCT01099761|143357321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED||||||ANCOVA|||||||0.012
71917616|NCT01099761|143357321|SUPERIORITY_OR_OTHER_LEGACY|||||||0.435|TWO_SIDED||||||ANCOVA|||||||0.435
71917617|NCT01099761|143357322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||ANCOVA|||||||0.039
71917618|NCT02237898|143357345|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71917619|NCT05307523|143357352|OTHER|Paired t-test for normally distributed data Wilcoxon Rank test for the not normally distributed data|||||<|0.05||||||Paired T-test for the normally distributed data and a Wilcoxon Rank test for the non-parametric data were used|Both Paired T-test and Wilcoxon Rank|The data included both normally and not normally distributed data for the baseline, mid-study, and final study assessment points.||||||<0.05
71917620|NCT01855867|143357362|SUPERIORITY|Statistical significance was determined at the alpha 0.05 level. The study regimen completion rates of participants in the current study taking a fixed dose once daily combination of elvitegravir/cobicistat/TDF/FTC were compared to historical controls who used PEP regimens consisting of TDF/FTC daily and raltegravir twice daily, or earlier regimens of twice daily zidovudine (AZT)/lamivudine (3TC) and a protease inhibitor, using chi-square tests for independence.|chi square||||<|0.05||||||Reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|Chi-squared|||using historical controls||||<0.05
71917621|NCT00678249|143357364|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71917622|NCT01708915|143357373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.362|STANDARD_ERROR_OF_MEAN|0.171|<|0.0001|TWO_SIDED|95.0|-1.699|-1.025||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-1.025|-1.699|<0.0001
71917623|NCT01708915|143357373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.983|STANDARD_ERROR_OF_MEAN|0.173|<|0.0001|TWO_SIDED|95.0|-1.324|-0.642||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.642|-1.324|<0.0001
71684656|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.0092|TWO_SIDED|95.0|1.122|2.254|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.254|1.122|0.0092
71876782|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.13||||0.6859||95.0|0.638|1.985||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||1.985|0.638|0.6859
71684657|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.974||||0.002|TWO_SIDED|95.0|1.488|5.942|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\< 140 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.942|1.488|0.0020
71876783|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.414||95.0|0.735|2.116||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.116|0.735|0.4140
71684658|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.142||||0.6524|TWO_SIDED|95.0|0.641|2.035|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10\*\*9/L at BL (\>=140 - \< 180 vs \>=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.035|0.641|0.6524
71684659|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.108|||<|0.0001|TWO_SIDED|95.0|0.037|0.311|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.311|0.037|<0.0001
71684660|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.389||||0.0429|TWO_SIDED|95.0|0.156|0.97|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.970|0.156|0.0429
71684661|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.549|TWO_SIDED|95.0|0.523|3.38|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.380|0.523|0.5490
71684662|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.136||||0.0008|TWO_SIDED|95.0|1.054|1.224|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.224|1.054|0.0008
71684663|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.855||||0.014|TWO_SIDED|95.0|1.133|3.037|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.037|1.133|0.0140
71684664|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.126||||0.0575|TWO_SIDED|95.0|0.015|1.068|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.068|0.015|0.0575
71684665|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.7128|TWO_SIDED|95.0|0.072|6.025|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.025|0.072|0.7128
71684666|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.505||||0.596|TWO_SIDED|95.0|0.04|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.318|0.040|0.5960
71876784|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.07||||0.7852||95.0|0.644|1.794||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.794|0.644|0.7852
71917624|NCT01708915|143357373|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.195||0.4171||95.0|-0.541|0.225||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.225|-0.541|0.4171
71917625|NCT01708915|143357374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.049|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001||95.0|-1.305|-0.793||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.793|-1.305|<0.0001
71684667|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.051||||0.0033|TWO_SIDED|95.0|1.27|3.311|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.311|1.270|0.0033
71684668|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.113||||0.0452|TWO_SIDED|95.0|1.002|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m\^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.236|1.002|0.0452
71876785|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7399||95.0|0.654|1.817||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.817|0.654|0.7399
71917626|NCT01708915|143357374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.731|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001||95.0|-1.003|-0.459||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||-0.459|-1.003|<0.0001
71684669|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||0.004|TWO_SIDED|95.0|0.043|0.551|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.551|0.043|0.0040
71876786|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.57||||0.1055||95.0|0.913|2.701||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||2.701|0.913|0.1055
71917627|NCT01708915|143357374|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.058|STANDARD_ERROR_OF_MEAN|0.152||0.7037||95.0|-0.356|0.241||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.||||0.241|-0.356|0.7037
71917628|NCT01708915|143357375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.655|STANDARD_ERROR_OF_MEAN|0.208|<|0.0001||95.0|-2.064|-1.247|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-1.247|-2.064|<0.0001
71917629|NCT01708915|143357375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.169|STANDARD_ERROR_OF_MEAN|0.209|<|0.0001||95.0|-1.578|-0.759|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.759|-1.578|<0.0001
71876787|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.41||||0.2107||95.0|0.829|2.401||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.401|0.829|0.2107
71876788|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.19||||0.527||95.0|0.697|2.046||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||2.046|0.697|0.5270
71876789|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.89||||0.6845||95.0|0.513|1.546||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.546|0.513|0.6845
71876790|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7737||95.0|0.522|1.619||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||1.619|0.522|0.7737
71876791|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.04||||0.8853||95.0|0.597|1.818||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||1.818|0.597|0.8853
71876792|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.7712||95.0|0.612|1.946||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||1.946|0.612|0.7712
71876793|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.9586||95.0|0.574|1.796||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||1.796|0.574|0.9586
71876794|NCT00232141|143272350|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.79||||0.3482||95.0|0.486|1.283||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.283|0.486|0.3482
71876795|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.1132||95.0|0.882|2.969||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1||2.969|0.882|0.1132
71876796|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.2||||0.4687||95.0|0.731|1.978||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2||1.978|0.731|0.4687
71876797|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.44||||0.1546||95.0|0.877|2.375||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3||2.375|0.877|0.1546
71917630|NCT01708915|143357375|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.466|STANDARD_ERROR_OF_MEAN|0.209||0.0259||95.0|-0.875|-0.056|||ANCOVA|The statistical model included baseline PI, centre, and treatment.||||-0.056|-0.875|0.0259
71917631|NCT01708915|143357376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.385|||<|0.0001||95.0|4.943|11.032|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||11.032|4.943|<0.0001
71684670|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.393||||0.0833|TWO_SIDED|95.0|0.137|1.131|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a||1.131|0.137|0.0833
71684671|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.141||||0.1439|TWO_SIDED|95.0|0.01|1.951|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.951|0.010|0.1439
71684672|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.4457|TWO_SIDED|95.0|0.024|5.194|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||5.194|0.024|0.4457
71684673|NCT01066793|142887235|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.142||||0.6258|TWO_SIDED|95.0|0.1|45.801|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||45.801|0.100|0.6258
71684674|NCT01313221|142887247|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.16|STANDARD_ERROR_OF_MEAN|9.99|||TWO_SIDED|95.0|-3.5|35.82|||||Adjusted for treatment in a mixed model|||35.82|-3.50|
71684675|NCT01313221|142887248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.23|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|95.0|-5.13|27.6||||||Difference in change from Week 12 to Week 16||27.60|-5.13|
71684676|NCT01313221|142887248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.56|STANDARD_ERROR_OF_MEAN|9.53|||TWO_SIDED|95.0|-2.21|35.32||||||Difference in change from Week 12 to Week 20||35.32|-2.21|
71684677|NCT02635009|142887283|SUPERIORITY|||||||0.28|||||||Fisher Exact|one-sided significance level = 0.05||Proportion of participants with deterioration in HVLT-R delayed recall score at six months: Null hypothesis = No difference between the arms; Alternative hypothesis = Arm 2 will have less deterioration than Arm 1. Ninety-eight evaluable participants per arm at six months provides 80% statistical power to detect a 14.5% absolute difference between the arms in proportion of participants with deterioration at six months using a one-sided Fisher's exact test.||||0.28
71684678|NCT02635009|142887284|NON_INFERIORITY|Null hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 \> 20%; Alternative hypothesis: Proportion of participants with relapse on Arm 2 - Arm 1 = 4.5%. Using a non-inferiority margin of 20% and an assumed difference in proportions of 4.5% under the alternative, a 2-sample test of difference in proportions with a 1-sided alpha of 0.1 requires 164 patients to achieve 85% statistical power. (Statistically significant p-value indicates non-inferiority.)||||||0.003|||||||Test of binomial proportions|||||||0.0030
71684679|NCT02635009|142887285|SUPERIORITY|||||||0.0598|||||||Gray's test|||||||0.0598
71684680|NCT02635009|142887286|SUPERIORITY|||||||0.78|||||||Chi-squared|||3 months||||0.78
71684681|NCT02635009|142887286|SUPERIORITY|||||||0.63|||||||Chi-squared|||6 months||||0.63
71684682|NCT02635009|142887286|SUPERIORITY|||||||0.84|||||||Chi-squared|||12 months||||0.84
71684683|NCT02635009|142887288|SUPERIORITY|||||||0.56|||||||Chi-squared|||3 months||||0.56
71684684|NCT02635009|142887288|SUPERIORITY|||||||0.75|||||||Chi-squared|||12 months||||0.75
71684685|NCT02635009|142887290|SUPERIORITY|||||||0.81|||||||Chi-squared|||3 months||||0.81
71684686|NCT02635009|142887290|SUPERIORITY|||||||0.93|||||||Chi-squared|||6 months||||0.93
71684687|NCT02635009|142887290|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
71684688|NCT02635009|142887292|SUPERIORITY|||||||0.54|||||||Chi-squared|||3 months||||0.54
71684689|NCT02635009|142887292|SUPERIORITY|||||||0.43|||||||Chi-squared|||6 months||||0.43
71684690|NCT02635009|142887292|SUPERIORITY|||||||0.25|||||||Chi-squared|||12 months||||0.25
71684691|NCT02635009|142887294|SUPERIORITY|||||||0.71|||||||Chi-squared|||3 months||||0.71
71684692|NCT02635009|142887294|SUPERIORITY|||||||0.079|||||||Chi-squared|||6 months||||0.079
71684693|NCT02635009|142887294|SUPERIORITY|||||||0.85|||||||Chi-squared|||12 months||||0.85
71684694|NCT02635009|142887296|SUPERIORITY|||||||0.043|||||||Chi-squared|||3 months||||0.043
71684695|NCT02635009|142887296|SUPERIORITY|||||||0.017|||||||Fisher Exact|||6 months||||0.017
71684696|NCT02635009|142887296|SUPERIORITY|||||||0.057|||||||Chi-squared|||12-month||||0.057
71684697|NCT02635009|142887299|SUPERIORITY|||||||0.1|||||||Chi-squared|||3 months||||0.10
71684698|NCT02635009|142887299|SUPERIORITY|||||||0.33|||||||Chi-squared|||6 months||||0.33
71684699|NCT02635009|142887299|SUPERIORITY|||||||0.29|||||||Chi-squared|||12 months||||0.29
71684700|NCT02635009|142887301|SUPERIORITY|||||||0.0021|||||||Chi-squared|||3 months||||0.0021
71684701|NCT02635009|142887301|SUPERIORITY|||||||0.007|||||||Chi-squared|||6 months||||0.0070
71684702|NCT02635009|142887301|SUPERIORITY|||||||0.35|||||||Chi-squared|||12 months||||0.35
71684703|NCT02635009|142887303|SUPERIORITY|||||||0.55|||||||Chi-squared|||3 months||||0.55
71684704|NCT02635009|142887303|SUPERIORITY|||||||0.062|||||||Chi-squared|||6 months||||0.062
71684705|NCT02635009|142887303|SUPERIORITY|||||||0.32|||||||Chi-squared|||12 months||||0.32
71684706|NCT02635009|142887305|SUPERIORITY|||||||0.7|||||||Chi-squared|||3 months||||0.70
71684707|NCT02635009|142887305|SUPERIORITY|||||||0.52|||||||Chi-squared|||6 months||||0.52
71684708|NCT02635009|142887305|SUPERIORITY|||||||0.73|||||||Chi-squared|||12 months||||0.73
71684709|NCT02635009|142887307|SUPERIORITY|||||||0.28|||||||Chi-squared|||3 months||||0.28
71684710|NCT02635009|142887307|SUPERIORITY|||||||0.094|||||||Chi-squared|||6 months||||0.094
71684711|NCT02635009|142887307|SUPERIORITY|||||||0.61|||||||Chi-squared|||||||0.61
71684712|NCT02635009|142887309|SUPERIORITY|||||||0.16|||||||Chi-squared|||3 months.||||0.16
71876798|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.23||||0.4216||95.0|0.7444|2.025||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4||2.025|0.7444|0.4216
71917632|NCT01708915|143357376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.62|||<|0.0001||95.0|2.469|5.308|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||5.308|2.469|<0.0001
71876799|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.92||||0.7479||95.0|0.556|1.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5||1.527|0.556|0.7479
71917633|NCT01708915|143357376|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.594||||0.0129||95.0|1.104|2.303|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios \> 1 favour Nicoboxil/Nonivamide.|||2.303|1.104|0.0129
71917634|NCT01045551|143357377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.98|TWO_SIDED|||||The a priori threshold for statistical significance was P\<0.05.|t-test, 2 sided|||||||0.98
71917635|NCT01045551|143357378|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_DEVIATION|0.9024|||TWO_SIDED|||||||||||||
71917636|NCT04223778|143357389|NON_INFERIORITY|Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points.|Estimated Difference|-1.49|||<|0.001|TWO_SIDED|95.0|-3.44|-0.34|||Miettinen and Nurminen|The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.||||-0.34|-3.44|<.001
71917637|NCT04223778|143357390|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|9.8|||||TWO_SIDED|95.0|3.3|16.3|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||16.3|3.3|
71917638|NCT04223778|143357391|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.8|||||TWO_SIDED|95.0|0.2|4.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||4.0|0.2|
71917639|NCT04223778|143357392|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.3|||||TWO_SIDED|95.0|-3.28|3.9|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<40 copies/mL||3.90|-3.28|
71917640|NCT04223778|143357392|OTHER|Doravirine/Islatravir (DOR/ISL)- Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.89|||||TWO_SIDED|95.0|-2.58|4.43|||||The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights.|HIV-1 RNA \<50 copies/mL||4.43|-2.58|
71917641|NCT04223778|143357395|OTHER|Difference in percentage versus Baseline Antiretroviral Therapy (ART). Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-8.9|||||TWO_SIDED|95.0|-13.4|-4.5|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|||-4.5|-13.4|
71917642|NCT04223778|143357400|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-19.75|||||TWO_SIDED|95.0|-33.07|-6.44|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Cholesterol||-6.44|-33.07|
71917643|NCT04223778|143357400|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.35|||||TWO_SIDED|95.0|-6.55|3.84|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting HDL Cholesterol||3.84|-6.55|
71917644|NCT04223778|143357400|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-13.94|||||TWO_SIDED|95.0|-24.69|-3.2|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting LDL Cholesterol||-3.20|-24.69|
71917645|NCT04223778|143357400|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-17.74|||||TWO_SIDED|95.0|-30.02|-5.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Non-HDL Cholesterol||-5.46|-30.02|
71917646|NCT04223778|143357400|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-21.28|||||TWO_SIDED|95.0|-45.51|2.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method.|Fasting Triglycerides||2.96|-45.51|
71917647|NCT04223778|143357401|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.17|||||TWO_SIDED|95.0|-10.43|2.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||2.09|-10.43|
71917648|NCT04223778|143357401|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.81|||||TWO_SIDED|95.0|-1.46|3.09|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||3.09|-1.46|
71917649|NCT04223778|143357401|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.87|||||TWO_SIDED|95.0|-9.47|1.74|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||1.74|-9.47|
71917650|NCT04223778|143357401|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-4.92|||||TWO_SIDED|95.0|-11.21|1.38|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||1.38|-11.21|
71917651|NCT04223778|143357401|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.65|||||TWO_SIDED|95.0|-16.14|19.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||19.43|-16.14|
71917652|NCT04223778|143357402|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|1.05|||||TWO_SIDED|95.0|-7.6|9.7|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||9.70|-7.60|
71917653|NCT04223778|143357402|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-3.16|||||TWO_SIDED|95.0|-6.37|0.05|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.05|-6.37|
71917654|NCT04223778|143357402|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|4.38|||||TWO_SIDED|95.0|-2.27|11.03|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||11.03|-2.27|
71917655|NCT04223778|143357402|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.63|||||TWO_SIDED|95.0|-3.93|11.19|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||11.19|-3.93|
71917656|NCT04223778|143357402|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-1.79|||||TWO_SIDED|95.0|-15.89|12.31|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||12.31|-15.89|
71917657|NCT04223778|143357403|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.41|||||TWO_SIDED|95.0|-32.05|-4.76|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||-4.76|-32.05|
71917658|NCT04223778|143357403|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.01|||||TWO_SIDED|95.0|-5.06|5.08|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||5.08|-5.06|
71684713|NCT02635009|142887309|SUPERIORITY|||||||0.017|||||||Chi-squared|||6 months. Assuming 50% of patients experience deterioration at 6 months, based on a prior study (RTOG-0212), a sample size of 198 participants per arm provides 94% power to detect a 50% relative reduction (50% on Arm 1 vs. 25% on Arm 2) in decline at 6 months using Fisher's exact test with a two-sided alpha=0.05.||||0.017
71684714|NCT02635009|142887309|SUPERIORITY|||||||0.56|||||||Chi-squared|||12-month||||0.56
71684715|NCT02635009|142887311|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
71684716|NCT02635009|142887311|SUPERIORITY|||||||0.45|||||||Chi-squared|||||||0.45
71684717|NCT02635009|142887311|SUPERIORITY|||||||0.25|||||||Chi-squared|||||||0.25
71684718|NCT02635009|142887313|SUPERIORITY|||||||0.35|||||||Chi-squared|||3 months||||0.35
71684719|NCT02635009|142887313|SUPERIORITY|||||||0.99|||||||Chi-squared|||6 months||||0.99
71684720|NCT02635009|142887313|SUPERIORITY|||||||0.94|||||||Chi-squared|||12 months||||0.94
71684721|NCT02635009|142887317|SUPERIORITY|||||||0.79||||||Two-side significance level = 0.05|Log Rank|||||||0.79
71684722|NCT02635009|142887318|SUPERIORITY|||||||0.93|||||||Gray's test|||||||0.93
71684723|NCT02636699|142887320|OTHER||Difference in Response Rates (%)|21.7|||<|0.001|TWO_SIDED|95.0|12.4|29.8|||Wald|||Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates ≥15%.||29.8|12.4|<0.001
71684724|NCT02636699|142887321|OTHER||Difference in Response Rates (%)|19.0||||0.105|TWO_SIDED|95.0|-6.4|38.4|||Wald|||"Screening ED subgroup 1:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||38.4|-6.4|0.105
71684725|NCT02636699|142887321|OTHER||Difference in Response Rates (%)|22.3|||<|0.001|TWO_SIDED|95.0|12.1|30.8|||Wald|||"Screening ED subgroup 2:~Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates \>0."||30.8|12.1|<0.001
71684726|NCT02636699|142887322|OTHER||Difference in Median CRD|297.0|||<|0.001|TWO_SIDED|95.0|130.0|317.0|||Wilcoxon rank-sum test|||The treatment effect was estimated using the Hodges-Lehmann estimate of the difference in median CRDs at Month 12.||317.0|130.0|<0.001
71684727|NCT01973335|142887329|SUPERIORITY||Mean Difference (Final Values)|30.0||||0.515|TWO_SIDED|95.0|-63.0|123.0||Not adjusted for multiple comparisons|t-test, 2 sided|||2x2 factorial design: both acetazolamide groups together are compared with both high-dose loop diuretic groups together||123|-63|0.515
71684728|NCT01973335|142887330|SUPERIORITY||Risk Difference (RD)|-0.2||||0.27|TWO_SIDED|||||Not adjusted for multiple comparisons|Fisher Exact|||2x2 factorial design: analysis according to spironolactone use||||0.270
71684729|NCT01636947|142887355|SUPERIORITY_OR_OTHER|||||||0.191|||||||Pearson's chi-square test|||||||0.191
71684730|NCT01636947|142887356|SUPERIORITY_OR_OTHER|||||||0.458|||||||Pearson's chi-square test|||Overall Stage p-value||||0.458
71684731|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-49.92|||<|0.001||90.0|-63.84|-35.99|||Mixed Effects Model Analysis|P-value is for Day 43.||||-35.99|-63.84|<0.001
71684732|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.85|||<|0.001||90.0|-48.78|-20.93|||Mixed Effects Model Analysis|P-value is for Day 57.||||-20.93|-48.78|<0.001
71684733|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-47.72|||<|0.001||90.0|-62.1|-33.34|||Mixed Effects Model Analysis|P-value is for Day 43.||||-33.34|-62.10|<0.001
71684734|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.26|||<|0.001||90.0|-46.69|-17.82|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.82|-46.69|<0.001
71684735|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.36|||<|0.001||90.0|-60.07|-30.64|||Mixed Effects Model Analysis|P-value is for Day 43.||||-30.64|-60.07|<0.001
71684736|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-32.04|||<|0.001||90.0|-46.76|-17.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-17.32|-46.76|<0.001
71684737|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.8|||<|0.001||90.0|-61.12|-32.49|||Mixed Effects Model Analysis|P-value is for Day 43.||||-32.49|-61.12|<0.001
71684738|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.64|||<|0.001||90.0|-58.95|-30.32|||Mixed Effects Model Analysis|P-value is for Day 57.||||-30.32|-58.95|<0.001
71684739|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.53||||0.44||90.0|-20.51|7.44|||Mixed Effect Model Analysis|P-value is for Day 127||||7.44|-20.51|0.440
71684740|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.108||90.0|-28.53|0.33|||Mixed Effect Model Analysis|P-value is for Day 127.||||0.33|-28.53|0.108
71684741|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.41||||0.013||90.0|-37.13|-7.69|||Mixed Effect Model Analysis|P-value is for Day 127.||||-7.69|-37.13|0.013
71684742|NCT01618916|142887413|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.93||||0.042||90.0|-32.42|-3.44|||Mixed Effect Model Analysis|P-value is for Day 127.||||-3.44|-32.42|0.042
71684743|NCT02867202|142887435|OTHER||||||<|0.05|||||||t-test, 2 sided|||Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \< 0.05 was considered statistically significant.||||<0.05
71876800|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.8||||0.3842||95.0|0.481|1.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6||1.330|0.481|0.3842
71876801|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.05||||0.845||95.0|0.627|1.769||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7||1.769|0.627|0.8450
71876802|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.864|2.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8||2.527|0.864|0.1602
71876803|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.6815||95.0|0.66|1.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9||1.890|0.660|0.6815
71876804|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.85||||0.5635||95.0|0.486|1.482||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10||1.482|0.486|0.5635
71876805|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.21||||0.49||95.0|0.699|2.104||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11||2.104|0.699|0.4900
71876806|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.48||||0.1602||95.0|0.856|2.575||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12||2.575|0.856|0.1602
71876807|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.17||||0.5819||95.0|0.663|2.079||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13||2.079|0.663|0.5819
71876808|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2796||95.0|0.768|2.432||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14||2.432|0.768|0.2796
71876809|NCT00232141|143272351|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.86||||0.5437||95.0|0.534|1.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF||1.390|0.534|0.5437
71876810|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.54|STANDARD_ERROR_OF_MEAN|2.53||0.5425||95.0|-3.44|6.52||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Disturbance.||6.52|-3.44|0.5425
71876811|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.25||0.3184||95.0|-0.75|0.25||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Quantity||0.25|-0.75|0.3184
71876812|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|2.92||0.9886||95.0|-5.81|5.72||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Adequacy||5.72|-5.81|0.9886
71876813|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|2.51||0.5742||95.0|-3.53|6.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Awaken Short of Breath or with Headache||6.35|-3.53|0.5742
71876814|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|2.5||0.5775||95.0|-3.54|6.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Somnolence||6.33|-3.54|0.5775
71876815|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.34|STANDARD_ERROR_OF_MEAN|3.21||0.004||95.0|3.02|15.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Snoring||15.66|3.02|0.0040
71876816|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.07|STANDARD_ERROR_OF_MEAN|1.98||0.5882||95.0|-2.83|4.97||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index I||4.97|-2.83|0.5882
71876817|NCT00232141|143272352|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.42|STANDARD_ERROR_OF_MEAN|1.89||0.4516||95.0|-2.3|5.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index II||5.14|-2.30|0.4516
71876818|NCT00232141|143272353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.39||0.5105||95.0|-0.51|1.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Anxiety||1.03|-0.51|0.5105
71876819|NCT00232141|143272353|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.37||0.2513||95.0|-0.3|1.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Depression||1.14|-0.30|0.2513
71876820|NCT00232141|143272354|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.27||0.5834||95.0|-0.38|0.67||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Severity Index||0.67|-0.38|0.5834
71876821|NCT00232141|143272354|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.25||0.7783||95.0|-0.43|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Interference Index||0.57|-0.43|0.7783
71917659|NCT04223778|143357403|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-14.12|||||TWO_SIDED|95.0|-25.81|-2.43|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||-2.43|-25.81|
71917660|NCT04223778|143357403|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-18.23|||||TWO_SIDED|95.0|-30.45|-6.0|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||-6.00|-30.45|
71876822|NCT00232141|143272355|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4776||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.34|-0.73|0.4776
71876823|NCT00232141|143272356|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0077||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.0077
71876824|NCT00232141|143272357|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3852||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.3852
71876825|NCT00232141|143272358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3097||95.0|-0.03|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Burning||0.10|-0.03|0.3097
71876826|NCT00232141|143272358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.6147||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pressing||0.04|-0.07|0.6147
71876827|NCT00232141|143272358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6838||95.0|-0.05|0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paroxysmal||0.07|-0.05|0.6838
71876828|NCT00232141|143272358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.6479||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Evoked||0.04|-0.07|0.6479
71876829|NCT00232141|143272358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.1849||95.0|-0.02|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paresthesia/dysesthesia||0.11|-0.02|0.1849
71876830|NCT00232141|143272358|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.5898||95.0|0.0|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Total Score||0|0|0.5898
71876831|NCT00232141|143272359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.29||0.6865||95.0|-0.45|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Static mechanical allodynia||0.68|-0.45|0.6865
71917661|NCT04223778|143357403|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-27.79|||||TWO_SIDED|95.0|-51.08|-4.49|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||-4.49|-51.08|
71917662|NCT04223778|143357403|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-14.12||||0.0094|TWO_SIDED|95.0|-27.56|-0.68||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-0.68|-27.56|0.0094
71917663|NCT04223778|143357403|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-18.23||||0.0021|TWO_SIDED|95.0|-32.28|-4.17||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|-4.17|-32.28|0.0021
71917664|NCT04223778|143357404|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.04|||||TWO_SIDED|95.0|-6.26|6.18|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||6.18|-6.26|
71917665|NCT04223778|143357404|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.35|||||TWO_SIDED|95.0|-1.84|2.54|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||2.54|-1.84|
71917666|NCT04223778|143357404|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.64|||||TWO_SIDED|95.0|-4.83|6.11|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||6.11|-4.83|
71917667|NCT04223778|143357404|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-0.49|||||TWO_SIDED|95.0|-6.81|5.83|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||5.83|-6.81|
71917668|NCT04223778|143357404|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-5.45|||||TWO_SIDED|95.0|-20.46|9.57|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||9.57|-20.46|
71917669|NCT04223778|143357404|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|0.64||||0.4093|TWO_SIDED|95.0|-5.63|6.9||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting LDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.90|-5.63|0.4093
71917670|NCT04223778|143357404|SUPERIORITY|Treatment Difference vs Baseline ART. Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI is less than 0 percentage points.|Mean Difference (Net)|-0.49||||0.4397|TWO_SIDED|95.0|-7.72|6.75||The significance level in ANCOVA model was 0.02497/2=0.012485. The p-value is statistically significant if it is \<0.02497/2=0.012485.|ANCOVA|||Fasting Non-HDL Cholesterol - Multiplicity Adjusted|The multiplicity adjusted 95% CIs for treatment difference were calculated from ANCOVA models with terms for baseline measurement and treatment.|6.75|-7.72|0.4397
71917671|NCT04223778|143357405|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.31|||||TWO_SIDED|95.0|-5.54|10.17|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Cholesterol||10.17|-5.54|
71917672|NCT04223778|143357405|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|-2.52|||||TWO_SIDED|95.0|-5.69|0.65|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting HDL Cholesterol||0.65|-5.69|
71917673|NCT04223778|143357405|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|2.34|||||TWO_SIDED|95.0|-3.73|8.42|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting LDL Cholesterol||8.42|-3.73|
71917674|NCT04223778|143357405|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|3.97|||||TWO_SIDED|95.0|-2.63|10.56|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Non-HDL Cholesterol||10.56|-2.63|
71917675|NCT04223778|143357405|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|10.5|||||TWO_SIDED|95.0|-3.97|24.96|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|Fasting Triglycerides||24.96|-3.97|
71917676|NCT04223778|143357406|OTHER|Treatment Difference vs Baseline ART. Type of statistical test 'other' denotes no hypothesis testing was conducted.|Estimated Difference|0.44|||||TWO_SIDED|95.0|-0.59|1.46|||||Difference in percentage versus (vs) Baseline ART was based on Miettinen \& Nurminen method|||1.46|-0.59|
71917677|NCT00887822|143357422|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.8636|TWO_SIDED|95.0|0.75|1.41|||Log Rank|The difference in distribution of survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.75|0.8636
71917678|NCT00887822|143357424|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.4709|TWO_SIDED|95.0|0.66|1.21|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.21|0.66|0.4709
71917679|NCT00887822|143357426|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.3685|TWO_SIDED|95.0|0.58|1.22|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.22|0.58|0.3685
71684744|NCT03292471|142887451|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.284|||||TWO_SIDED|95.0|-2.07|2.92|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.92|-2.07|
71684745|NCT03292471|142887451|SUPERIORITY|Dependent variable: PNT T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Pre-treatment, Follow-up) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions (PNT raw score converted to T-score scale with m = 50, sd = 10 based on sample estimates from Fergadiotis, Hula, \& Kellough, 2015)|Highest Density Interval of Posterior Di|0.02|||||TWO_SIDED|95.0|-2.38|2.46|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.46|-2.38|
71684746|NCT03292471|142887452|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time point (Entry, Exit) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.997|||||TWO_SIDED|95.0|-0.0719|2.25|||||Direction of comparison: Group A (Standard Protocol) and post-treatment timepoint were set as reference values|Baysian Multivariate Analysis of Variance||2.25|-0.0719|
71684747|NCT03292471|142887452|SUPERIORITY|Dependent variable: CAT Mean-modality T-score Fixed Effects: Group Assignment (A = Standard, B= Priming), Time-point (Pre-treatment, Post-treatment) Random Effects: Participant (intercept and slope) Priors for slope and intercept were set as t-distributions|Highest Density Interval of Posterior Di|0.443|||||TWO_SIDED|95.0|-0.596|1.58|||||Direction of comparison: Group A (Standard Protocol) and follow-up (2 months post-treatment) timepoint were set as reference values|Baysian Multivariate Analysis of Variance||1.58|-0.596|
71684748|NCT00911586|142887459|OTHER|Part 1 of piecewise linear regression model.|Slope|-4.077|STANDARD_ERROR_OF_MEAN|16.02||0.806|TWO_SIDED||||||Regression, Linear|Part 1 of piecewise linear regression model.|Part 1 of piecewise linear regression model.|||||0.8060
71684749|NCT00911586|142887460|OTHER|Part 2 of piecewise linear regression model.|Slope|4.114|STANDARD_ERROR_OF_MEAN|18.456||0.8286|TWO_SIDED||||||Regression, Linear|Part 2 of piecewise linear regression model.|Part 2 of piecewise linear regression model.|||||0.8286
71684750|NCT01017601|142887517|OTHER|||||||0.5|||||||Wilcoxon Rank Sum|||||||0.50
71876832|NCT00232141|143272359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.25||0.3787||95.0|-0.71|0.27||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Dynamic mechanical allodynia||0.27|-0.71|0.3787
71917680|NCT00887822|143357428|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.8589|TWO_SIDED|95.0|0.67|1.41|||Log Rank|The difference in distribution of disease progression between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.41|0.67|0.8589
71917681|NCT00887822|143357429|SUPERIORITY_OR_OTHER||Difference in Response Rates|7.02||||0.348|TWO_SIDED|95.0|-8.3|22.4|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||22.4|-8.3|0.3480
71917682|NCT00887822|143357430|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.0462|TWO_SIDED|95.0|0.29|1.0|||Log Rank|The difference in distribution of response between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.|||1.00|0.29|0.0462
71917683|NCT00887822|143357431|SUPERIORITY_OR_OTHER||Difference in Disease Control Rates|0.45||||0.9426|TWO_SIDED|95.0|-12.4|13.3|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method|||13.3|-12.4|0.9426
71917684|NCT02045979|143357434|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 percent (%).|ratio of the geometric means|108.62|||||TWO_SIDED|90.0|98.5|119.79|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.79|98.50|
71917685|NCT02045979|143357434|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|101.27|||||TWO_SIDED|90.0|92.45|110.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.94|92.45|
71684751|NCT01017601|142887518|OTHER|||||||0.96|||||||Wilcoxon Rank Sum|||||||0.96
71876833|NCT00232141|143272359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.35||0.7704||95.0|-0.79|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Punctate hyperalgesia testing area||0.59|-0.79|0.7704
71684752|NCT01017601|142887519|OTHER|||||||0.54|||||||Fisher Exact|||||||0.54
71684753|NCT01017601|142887520|OTHER|||||||1|||||||Fisher Exact|||||||1.0
71684754|NCT02051335|142887521|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.556||0.573|TWO_SIDED|95.0|-1.4|0.8||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.8|-1.4|0.573
71684755|NCT02051335|142887521|SUPERIORITY_OR_OTHER||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.55||0.21|TWO_SIDED|95.0|-1.8|0.4||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||0.4|-1.8|0.210
71684756|NCT02051335|142887521|SUPERIORITY_OR_OTHER||LS mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.547||0.821|TWO_SIDED|95.0|-1.0|1.2||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.2|-1.0|0.821
71684757|NCT02051335|142887521|SUPERIORITY_OR_OTHER||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.549||0.426|TWO_SIDED|95.0|-0.7|1.5||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.5|-0.7|0.426
71684758|NCT02051335|142887521|SUPERIORITY_OR_OTHER||LS mean difference|0.82|STANDARD_ERROR_OF_MEAN|0.53||0.126|TWO_SIDED|95.0|-0.2|1.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.9|-0.2|0.126
71684759|NCT02051335|142887522|SUPERIORITY_OR_OTHER||LS mean difference|1.93|STANDARD_ERROR_OF_MEAN|0.992||0.057|TWO_SIDED|95.0|-0.1|3.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||3.9|-0.1|0.057
71684760|NCT02051335|142887522|SUPERIORITY_OR_OTHER||LS mean difference|-0.84|STANDARD_ERROR_OF_MEAN|0.981||0.394|TWO_SIDED|95.0|-2.8|1.1||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||1.1|-2.8|0.394
71684761|NCT02051335|142887522|SUPERIORITY_OR_OTHER||LS mean difference|2.01|STANDARD_ERROR_OF_MEAN|0.972||0.042|TWO_SIDED|95.0|0.1|4.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.0|0.1|0.042
71684762|NCT02051335|142887522|SUPERIORITY_OR_OTHER||LS mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.974||0.928|TWO_SIDED|95.0|-1.9|2.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||2.0|-1.9|0.928
71684763|NCT02051335|142887522|SUPERIORITY_OR_OTHER||LS mean difference|2.86|STANDARD_ERROR_OF_MEAN|0.943||0.004|TWO_SIDED|95.0|1.0|4.7||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA|||||4.7|1.0|0.004
71684764|NCT02638259|142887532|EQUIVALENCE|A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.|Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.097|||TWO_SIDED|95.0|-0.26|0.12||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval \[-0.6; 0.6\]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.||0.12|-0.26|
71684765|NCT02638051|142887587|SUPERIORITY_OR_OTHER|||||||0.014|||||||Chi-squared|||"Applies to Objective Response Rate (ORR)"||||0.0140
71684766|NCT02638051|142887588|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Chi-squared|||"Applies to All Adverse Events rate"||||0.0016
71684767|NCT02638051|142887588|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Abdominal pain rate"||||>0.05
71684768|NCT02638051|142887588|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Gastrointestinal reactions"||||>0.05
71684769|NCT02638051|142887588|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Damage of hepatic or renal function"||||>0.05
71684770|NCT02638051|142887588|SUPERIORITY_OR_OTHER|||||||0.0215|||||||Chi-squared|||"Applies to Bone marrow depression"||||0.0215
71684771|NCT02638051|142887589|SUPERIORITY_OR_OTHER|||||||0.0053|||||||Chi-squared|||"Applies to Better QoL"||||0.0053
71684772|NCT02638051|142887589|SUPERIORITY_OR_OTHER|||||||0.0527|||||||Chi-squared|||"Applies to No Change"||||0.0527
71684773|NCT02638051|142887589|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||"Applies to Worse QoL"||||>0.05
71684774|NCT00508157|142887604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.28|||||TWO_SIDED|95.0|-19.14|-2.66|||ANCOVA|ANCOVA model: log of on-treatment to baseline ratio = log of baseline value, treatment, previous antipsychotic.|Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1.|Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16||-2.66|-19.14|
71684775|NCT00508157|142887605|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|A relative risk \< 1 favors Aripiprazole over Control Group.||null hypothesis: no difference between Aripiprazole and Control Group||1.06|0.54|
71684776|NCT04114656|142887622|OTHER||Posterior Ratio to placebo|0.993|||||TWO_SIDED|95.0|0.968|1.02|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.020|0.968|
71684777|NCT04114656|142887623|OTHER||Posterior ratio to placebo|1.0|||||TWO_SIDED|95.0|0.89|1.12|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.12|0.89|
71684778|NCT04114656|142887624|OTHER||Posterior ratio to placebo|0.98|||||TWO_SIDED|95.0|0.91|1.05|||||Treatment comparison ratio of GSK3858279 and placebo using posterior median ratio and 95% credible interval is presented. Analysis was performed using Bayesian Mixed Repeated measures Analysis of Covariance (ANCOVA) model.|||1.05|0.91|
71684779|NCT03282591|142887638|SUPERIORITY||Mean Difference (Final Values)|31.4||||0.9942|ONE_SIDED|95.0||56.9|||Mixed Models Analysis|||||56.9||0.9942
71684780|NCT02173379|142887702|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.||||||0.0244|ONE_SIDED|97.5|||||Farrington-Manning|||"The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE \< ∆TLF."||||0.0244
71684781|NCT02173379|142887703|NON_INFERIORITY|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 4.8%, to be compared with a one-sided significance level of 0.025.||||||0.0006|||||||Farrington-Manning|||||||0.0006
71917686|NCT02045979|143357434|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|94.02|||||TWO_SIDED|90.0|86.01|102.78|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.78|86.01|
71917687|NCT02045979|143357435|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|107.32|||||TWO_SIDED|90.0|98.49|116.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||116.94|98.49|
71917688|NCT02045979|143357435|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|99.93|||||TWO_SIDED|90.0|92.15|108.37|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.37|92.15|
71917689|NCT02045979|143357435|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|93.66|||||TWO_SIDED|90.0|86.76|101.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.11|86.76|
71917690|NCT02045979|143357436|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|100.85|||||TWO_SIDED|90.0|95.15|106.88|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.88|95.15|
71917691|NCT02045979|143357436|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|96.39|||||TWO_SIDED|90.0|91.06|102.03|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.03|91.06|
71917692|NCT02045979|143357436|NON_INFERIORITY_OR_EQUIVALENCE|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|95.93|||||TWO_SIDED|90.0|90.83|101.33|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.33|90.83|
71917693|NCT02045979|143357437|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% Confidence Interval (CI) for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.3|||||TWO_SIDED|90.0|91.54|105.55|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.55|91.54|
71917694|NCT02045979|143357437|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|96.05|||||TWO_SIDED|90.0|89.27|103.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.36|89.27|
71917695|NCT02045979|143357437|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.11|||||TWO_SIDED|90.0|91.42|105.27|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.27|91.42|
71917696|NCT02045979|143357438|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|99.61|||||TWO_SIDED|90.0|93.66|105.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||105.94|93.66|
71917697|NCT02045979|143357438|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.19|||||TWO_SIDED|90.0|91.39|103.35|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.35|91.39|
71917698|NCT02045979|143357438|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.97|||||TWO_SIDED|90.0|92.58|103.68|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.68|92.58|
71917699|NCT02045979|143357439|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.23|||||TWO_SIDED|90.0|95.45|107.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||107.36|95.45|
71684782|NCT04767529|142887894|SUPERIORITY||percent difference|22.6||||0.025|TWO_SIDED|95.0|3.8|41.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the EFX 28 mg and placebo group|% difference from placebo (efruxifermin 28 mg - placebo)|Comparison between proportion of participants in efruxifermin 28 mg group who met the primary endpoint vs the placebo group||41.4|3.8|0.025
71917700|NCT02045979|143357439|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.83|||||TWO_SIDED|90.0|93.27|104.72|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||104.72|93.27|
71917701|NCT02045979|143357439|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.01|||||TWO_SIDED|90.0|93.15|103.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||103.11|93.15|
71917702|NCT02045979|143357440|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|103.68|||||TWO_SIDED|90.0|97.47|110.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||110.29|97.47|
71917703|NCT02045979|143357440|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.16|||||TWO_SIDED|90.0|94.37|106.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||106.29|94.37|
71876834|NCT00232141|143272359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.33||0.6088||95.0|-0.82|0.48||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Temporal summation to tactile stimuli||0.48|-0.82|0.6088
71876835|NCT00232141|143272359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.33||0.3767||95.0|-0.93|0.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold allodynia testing area||0.35|-0.93|0.3767
71876836|NCT00232141|143272359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.38||0.7689||95.0|-0.64|0.86||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold hyperalgesia testing area||0.86|-0.64|0.7689
71876837|NCT00232141|143272360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.25||0.1277||95.0|-0.86|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||||0.11|-0.86|0.1277
71876838|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.18||0.0469||95.0|-0.71|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.00|-0.71|0.0469
71876839|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.23||0.0067||95.0|-1.08|-0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||-0.18|-1.08|0.0067
71876840|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.27||0.031||95.0|-1.1|-0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3||-0.05|-1.10|0.0310
71876841|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34|STANDARD_ERROR_OF_MEAN|0.27||0.2088||95.0|-0.86|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4||0.19|-0.86|0.2088
71876842|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.26||0.1849||95.0|-0.87|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5||0.17|-0.87|0.1849
71876843|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.27||0.0452||95.0|-1.09|-0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||-0.01|-1.09|0.0452
71876844|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.29||0.0359||95.0|-1.18|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7||-0.04|-1.18|0.0359
71876845|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.29||0.0184||95.0|-1.26|-0.12||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8||-0.12|-1.26|0.0184
71876846|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.29||0.1043||95.0|-1.06|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9||0.10|-1.06|0.1043
71876847|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.29||0.1053||95.0|-1.04|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.10|-1.04|0.1053
71917704|NCT02045979|143357440|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.02|||||TWO_SIDED|90.0|92.07|102.24|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.24|92.07|
71917705|NCT02045979|143357441|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|106.57|||||TWO_SIDED|90.0|99.07|114.63|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||114.63|99.07|
71876848|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.3||0.144||95.0|-1.03|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11||0.15|-1.03|0.1440
71876849|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.32||0.0866||95.0|-1.17|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12||0.08|-1.17|0.0866
71876850|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.32||0.0359||95.0|-1.3|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13||-0.04|-1.30|0.0359
71876851|NCT00232141|143272361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.34||0.0711||95.0|-1.3|0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.05|-1.30|0.0711
71876852|NCT00232141|143272363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.23||0.0685||95.0|-0.89|0.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.03|-0.89|0.0685
71876853|NCT00232141|143272363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.28||0.928||95.0|-0.52|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.57|-0.52|0.9280
71876854|NCT00232141|143272363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.29||0.6672||95.0|-0.71|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.71|0.6672
71876855|NCT00232141|143272363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.9731||95.0|-0.57|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.57|0.9731
71876856|NCT00232141|143272363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.9045||95.0|-0.61|0.69||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.69|-0.61|0.9045
71876857|NCT00232141|143272363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.3||0.8298||95.0|-0.53|0.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.66|-0.53|0.8298
71876858|NCT00232141|143272364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.24||0.8605||95.0|-0.52|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.44|-0.52|0.8605
71876859|NCT00232141|143272364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8348||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.58|0.8348
71876860|NCT00232141|143272364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.26||0.2227||95.0|-0.83|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.19|-0.83|0.2227
71876861|NCT00232141|143272364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.27||0.4753||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.34|-0.73|0.4753
71876862|NCT00232141|143272364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.27||0.6017||95.0|-0.4|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.68|-0.40|0.6017
71876863|NCT00232141|143272364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.26||0.6158||95.0|-0.38|0.64||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.64|-0.38|0.6158
71876864|NCT00232141|143272365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.22||0.239||95.0|-0.69|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.17|-0.69|0.2390
71876865|NCT00232141|143272365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.24||0.9444||95.0|-0.49|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.45|-0.49|0.9444
71876866|NCT00232141|143272365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.27||0.7386||95.0|-0.63|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.63|0.7386
71917706|NCT02045979|143357441|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.94|||||TWO_SIDED|90.0|94.24|108.12|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||108.12|94.24|
71684783|NCT04767529|142887894|SUPERIORITY||percent difference|22.5||||0.036|TWO_SIDED|95.0|1.6|43.3||Threshold for significance was p\<0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for stratification factors is used for comparison between the EFX 50 mg and placebo group|% difference from placebo (efruxifermin 50 mg - placebo)|Comparison between proportion of participants in efruxifermin 50 mg group who met the primary endpoint vs the placebo group||43.3|1.6|0.036
71684784|NCT04767529|142887895|SUPERIORITY||percent difference|21.8||||0.07|TWO_SIDED|95.0|-1.3|45.0||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||||45.0|-1.3|0.070
71684785|NCT04767529|142887895|SUPERIORITY||percent difference|51.9|||<|0.001|TWO_SIDED|95.0|31.2|72.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||72.7|31.2|<0.001
71684786|NCT04767529|142887896|SUPERIORITY||percent difference|31.9||||0.002|TWO_SIDED|95.0|12.9|50.9||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparison between the efruxifermin 28 mg and placebo group||Week 24||50.9|12.9|0.002
71684787|NCT04767529|142887896|SUPERIORITY||percent difference|61.7|||<|0.001|TWO_SIDED|95.0|44.1|79.4||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||79.4|44.1|<0.001
71684788|NCT04767529|142887896|SUPERIORITY||percent difference|38.9||||0.002|TWO_SIDED|95.0|17.2|60.7||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between efruxifermin 28 mg and placebo groups||Week 96||60.7|17.2|0.002
71684789|NCT04767529|142887896|SUPERIORITY||percent difference|33.2||||0.006|TWO_SIDED|95.0|10.5|55.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo group||Week 96||55.8|10.5|0.006
71684790|NCT04767529|142887897|SUPERIORITY||percent difference|20.0||||0.053|TWO_SIDED|95.0|0.4|39.5||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo group||Week 24||39.5|0.4|0.053
71684791|NCT04767529|142887897|SUPERIORITY||percent difference|19.9||||0.069|TWO_SIDED|95.0|-1.5|41.2||Threshold for statistical significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 24||41.2|-1.5|0.069
71684792|NCT04767529|142887897|SUPERIORITY||percent difference|19.0||||0.123|TWO_SIDED|95.0|-4.8|42.8||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 28 mg and placebo groups||Week 96||42.8|-4.8|0.123
71876867|NCT00232141|143272365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.27||0.3493||95.0|-0.79|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.28|-0.79|0.3493
71917707|NCT02045979|143357441|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|95.37|||||TWO_SIDED|90.0|89.53|101.6|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||101.60|89.53|
71684793|NCT04767529|142887897|SUPERIORITY||percent difference|49.0|||<|0.001|TWO_SIDED|95.0|27.7|70.2||Threshold for significance set at p\<0.05|Cochran-Mantel-Haenszel|A Cochran-Mantel-Haenszel test adjusting for stratification factors was used for comparisons between the efruxifermin 50 mg and placebo groups||Week 96||70.2|27.7|<0.001
71917708|NCT02045979|143357442|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|108.7|||||TWO_SIDED|90.0|98.54|119.9|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||119.90|98.54|
71917709|NCT02045979|143357442|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.36|||||TWO_SIDED|90.0|92.51|111.05|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||111.05|92.51|
71684794|NCT04767529|142887898|SUPERIORITY|Week 24|Mean Difference (Net)|-6.9|STANDARD_ERROR_OF_MEAN|1.1|<|0.001|TWO_SIDED|95.0|-9.09|-4.71||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM: fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariate for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-4.71|-9.09|<0.001
71684795|NCT04767529|142887898|SUPERIORITY|Week 24|Mean Difference (Net)|-9.2|STANDARD_ERROR_OF_MEAN|1.12|<|0.001|TWO_SIDED|95.0|-11.47|-7.02||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-7.02|-11.47|<0.001
71684796|NCT04767529|142887898|SUPERIORITY|Week 96|Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|1.31||0.005|TWO_SIDED|95.0|-6.39|-1.18||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 28 mg and placebo groups||-1.18|-6.39|0.005
71684797|NCT04767529|142887898|SUPERIORITY|Week 96|Mean Difference (Net)|-5.8|STANDARD_ERROR_OF_MEAN|1.29|<|0.001|TWO_SIDED|95.0|-8.38|-3.25||Threshold for significance set at p\<0.05|Mixed Models Analysis|MMRM:fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction and baseline as covariates for comparison||Percent change from baseline in hepatic fat fraction between the EFX 50 mg and placebo groups||-3.25|-8.38|<0.001
71684798|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|-51.6|STANDARD_ERROR_OF_MEAN|9.86|<|0.001|TWO_SIDED|95.0|-71.17|-32.11|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-32.11|-71.17|<0.001
71684799|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|-55.2|STANDARD_ERROR_OF_MEAN|9.83|<|0.001|TWO_SIDED|95.0|-74.63|-35.71|||Mixed Models Analysis|||Treatment comparison of least squares (LS) mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-35.71|-74.63|<0.001
71684800|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|-43.0|STANDARD_ERROR_OF_MEAN|11.48|<|0.001|TWO_SIDED|95.0|-65.73|-20.27||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of least squares (LS) mean change from baseline (EFX 28 mg - placebo) in triglycerides (mg/dL)||-20.27|-65.73|<0.001
71684801|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|-47.8|STANDARD_ERROR_OF_MEAN|11.4|<|0.001|TWO_SIDED|95.0|-70.39|-25.24||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in triglycerides (mg/dL)||-25.24|-70.39|<0.001
71684802|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|11.0|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|7.92|14.17|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||14.17|7.92|<0.001
71684803|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|12.5|STANDARD_ERROR_OF_MEAN|1.57|<|0.001|TWO_SIDED|95.0|9.35|15.57|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||15.57|9.35|<0.001
71876868|NCT00232141|143272365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.3||0.6596||95.0|-0.46|0.73||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.73|-0.46|0.6596
71684804|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|2.12||0.005|TWO_SIDED|95.0|1.84|10.23||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in HDL cholesterol (mg/dL)||10.23|1.84|0.005
71684805|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|9.5|STANDARD_ERROR_OF_MEAN|2.11|<|0.001|TWO_SIDED|95.0|5.3|13.65||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in HDL cholesterol (mg/dL)||13.65|5.30|<0.001
71684806|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|-14.4|STANDARD_ERROR_OF_MEAN|4.99||0.005|TWO_SIDED|95.0|-24.28|-4.53|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||-4.53|-24.28|0.005
71917710|NCT02045979|143357442|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|94.04|||||TWO_SIDED|90.0|86.01|102.82|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.|||102.82|86.01|
71917711|NCT02425891|143357444|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.8||||0.0025|TWO_SIDED|95.0|0.69|0.92|||Log Rank|||||0.92|0.69|0.0025
71917712|NCT02425891|143357445|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.49|0.78|||Log Rank|||||0.78|0.49|<.0001
71917713|NCT02425891|143357446|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.87||||0.077|TWO_SIDED|95.0|0.75|1.02|||Log Rank|||||1.02|0.75|0.0770
71917714|NCT02425891|143357447|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.67||||0.0016|TWO_SIDED|95.0|0.53|0.86|||Log Rank|||||0.86|0.53|0.0016
71917715|NCT02425891|143357448|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|10.12||||0.0021|TWO_SIDED|95.0|3.4|16.84|||Cochran-Mantel-Haenszel|||||16.84|3.40|0.0021
71684807|NCT04767529|142887899|SUPERIORITY|Week 24|Median Difference (Net)|-13.6|STANDARD_ERROR_OF_MEAN|4.98||0.007|TWO_SIDED|95.0|-23.5|-3.76|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||-3.76|-23.50|0.007
71684808|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|7.04||0.99|TWO_SIDED|95.0|-13.86|14.04||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in LDL cholesterol (mg/dL)||14.04|-13.86|0.990
71684809|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|7.01||0.98|TWO_SIDED|95.0|-14.07|13.71||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in LDL cholesterol (mg/dL)||13.71|-14.07|0.980
71684810|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|-22.6|STANDARD_ERROR_OF_MEAN|5.52|<|0.001|TWO_SIDED|95.0|-33.58|-11.71|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||-11.71|-33.58|<0.001
71876869|NCT00232141|143272365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.27||0.4075||95.0|-0.31|0.77||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.77|-0.31|0.4075
71876870|NCT00232141|143272366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.23||0.0202||95.0|-1.01|-0.09||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.09|-1.01|0.0202
71876871|NCT00232141|143272366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8865||95.0|-0.55|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.47|-0.55|0.8865
71876872|NCT00232141|143272366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.9964||95.0|-0.54|0.54||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.54|-0.54|0.9964
71684811|NCT04767529|142887899|SUPERIORITY|Week 24|Mean Difference (Net)|-22.7|STANDARD_ERROR_OF_MEAN|5.51|<|0.001|TWO_SIDED|95.0|-33.56|-11.74|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50mg - placebo) in non-HDL cholesterol (mg/dL)||-11.74|-33.56|<0.001
71684812|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|7.9||0.443|TWO_SIDED|95.0|-21.72|9.56||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in non-HDL cholesterol (mg/dL)||9.56|-21.72|0.443
71684813|NCT04767529|142887899|SUPERIORITY|Week 96|Mean Difference (Net)|-8.2|STANDARD_ERROR_OF_MEAN|7.86||0.299|TWO_SIDED|95.0|-23.77|7.36||Threshold for significance set at p\<0.05|Mixed Models Analysis||LS Means and differences, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX and placebo group|Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in non-HDL cholesterol (mg/dL)||7.36|-23.77|0.299
71684814|NCT04767529|142887908|SUPERIORITY|Week 24|Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|1.18||0.75|TWO_SIDED|95.0|-1.96|2.72||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 28 mg - placebo) in body weight (kg)||2.72|-1.96|0.750
71876873|NCT00232141|143272366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5993||95.0|-0.7|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.70|0.5993
71876874|NCT00232141|143272366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.31||0.3553||95.0|-0.33|0.9||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.90|-0.33|0.3553
71876875|NCT00232141|143272366|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2771||95.0|-0.25|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.88|-0.25|0.2771
71917716|NCT02425891|143357449|SUPERIORITY|Stratified Analysis|Difference in Overall Response Rates|16.3||||0.0016|TWO_SIDED|95.0|5.67|26.92|||Cochran-Mantel-Haenszel|||||26.92|5.67|0.0016
71917717|NCT02425891|143357450|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.78||||0.0285|TWO_SIDED|95.0|0.63|0.98|||Log Rank|||||0.98|0.63|0.0285
71917718|NCT02425891|143357451|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0047|TWO_SIDED|95.0|0.43|0.86|||Log Rank|||||0.86|0.43|0.0047
71917719|NCT02425891|143357452|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8078|TWO_SIDED|95.0|0.81|1.18|||Log Rank|||||1.18|0.81|0.8078
71876876|NCT00232141|143272367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.26||0.2352||95.0|-0.82|0.2||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.20|-0.82|0.2352
71876877|NCT00232141|143272367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7607||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.60|0.7607
71876878|NCT00232141|143272367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.27||0.6563||95.0|-0.64|0.4||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.40|-0.64|0.6563
71876879|NCT00232141|143272367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.27||0.8319||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.47|-0.58|0.8319
71876880|NCT00232141|143272367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3086||95.0|-0.28|0.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.89|-0.28|0.3086
71876881|NCT00232141|143272367|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.7972||95.0|-0.48|0.62||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.62|-0.48|0.7972
71876882|NCT00232141|143272368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.1863||95.0|-0.94|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.18|-0.94|0.1863
71876883|NCT00232141|143272368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|-0.31||0.5953||95.0|-0.77|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.44|-0.77|0.5953
71876884|NCT00232141|143272368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.28||0.508||95.0|-0.73|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.36|-0.73|0.5080
71876885|NCT00232141|143272368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5842||95.0|-0.7|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.39|-0.70|0.5842
71876886|NCT00232141|143272368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.3||0.4286||95.0|-0.35|0.83||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.83|-0.35|0.4286
71876887|NCT00232141|143272368|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.28||0.5766||95.0|-0.4|0.71||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.71|-0.40|0.5766
71876888|NCT00232141|143272369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.5493||95.0|-0.73|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.39|-0.73|0.5493
71876889|NCT00232141|143272369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9875||95.0|-0.58|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.59|-0.58|0.9875
71917720|NCT02425891|143357453|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.98||||0.8879|TWO_SIDED|95.0|0.73|1.31|||Log Rank|||||1.31|0.73|0.8879
71917721|NCT02145429|143357464|OTHER||Hazard Ratio (HR)|0.32||||0.04|TWO_SIDED|95.0|0.1|0.98|||Log Rank|||||0.98|0.10|0.04
71917722|NCT02145429|143357465|OTHER||Mean Difference (Final Values)|-1.18|||<|0.001|TWO_SIDED|95.0|-2.03|-0.31|||Mixed Models Analysis|||||-0.31|-2.03|<0.001
71917723|NCT02145429|143357466|OTHER||Mean Difference (Final Values)|-0.14||||0.26|TWO_SIDED|95.0|-1.89|1.62|||Mixed Models Analysis|||||1.62|-1.89|0.26
71917724|NCT00723489|143357484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.86|TWO_SIDED|95.0|-0.3|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.3|0.86
71684815|NCT04767529|142887908|SUPERIORITY|Week 24|Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.18||0.042|TWO_SIDED|95.0|-4.75|-0.09||Threshold for significance set at p\<0.05|Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||-0.09|-4.75|0.042
71684816|NCT04767529|142887908|SUPERIORITY|Week 96|Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|2.07||0.564|TWO_SIDED|95.0|-2.9|5.29|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (28 mg EFX - placebo) in body weight (kg)||5.29|-2.90|0.564
71876890|NCT00232141|143272369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.29||0.6931||95.0|-0.68|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.45|-0.68|0.6931
71684817|NCT04767529|142887908|SUPERIORITY|Week 96|Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|2.06||0.348|TWO_SIDED|95.0|-6.02|2.14|||Mixed Models Analysis|||Treatment comparison of LS mean change from baseline (EFX 50 mg - placebo) in body weight (kg)||2.14|-6.02|0.348
71684818|NCT04767529|142887909|SUPERIORITY|Week 24|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.24||0.102|TWO_SIDED|95.0|-4.5|0.4|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||0.4|-4.5|0.102
71684819|NCT04767529|142887909|SUPERIORITY|Week 24|Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|1.26||0.009|TWO_SIDED|95.0|-5.8|-0.8|||Mixed Models Analysis|||Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.8|-5.8|0.009
71917725|NCT00723489|143357485|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.86|TWO_SIDED|95.0|-0.2|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.2|-0.2|0.86
71917726|NCT00723489|143357486|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.1|TWO_SIDED|95.0|-0.5|0.05||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.05|-0.5|0.10
71917727|NCT00723489|143357487|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.66|TWO_SIDED|95.0|-0.2|0.3||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) - Mean (Non-AD)|||0.3|-0.2|0.66
71917728|NCT00723489|143357488|SUPERIORITY_OR_OTHER|||||||0.24||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.24
71917729|NCT00723489|143357489|SUPERIORITY_OR_OTHER|||||||0.43||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||||||0.43
71917730|NCT00723489|143357490|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.1||||0.48|TWO_SIDED|95.0|-0.1|0.3||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.3|-0.1|0.48
71917731|NCT00723489|143357491|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.3||||0.036|TWO_SIDED|95.0|-0.5|-0.02||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.02|-0.5|0.036
71917732|NCT00723489|143357492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|0.04||||0.82|TWO_SIDED|95.0|-0.3|0.4||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC -(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing||0.4|-0.3|0.82
71917733|NCT00723489|143357493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values) Day 30|-0.4||||0.045|TWO_SIDED|95.0|-0.7|-0.01||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) - Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing||-0.01|-0.7|0.045
71917734|NCT01599585|143357494|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.4|||||TWO_SIDED|90.0|0.12|0.68||||||||.68|.12|
71917735|NCT01599585|143357506|NON_INFERIORITY_OR_EQUIVALENCE|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.47|||||TWO_SIDED|90.0|0.16|0.78||||||||.78|.16|
71917736|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.062|STANDARD_ERROR_OF_MEAN|0.0901|||TWO_SIDED|90.0|-0.087|0.211|||mixed model repeated measures|||Week 12||0.211|-0.087|
71917737|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.084|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|-0.066|0.234|||mixed model repeated measures|||Week 12||0.234|-0.066|
71917738|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.096|STANDARD_ERROR_OF_MEAN|0.1198|||TWO_SIDED|90.0|-0.102|0.294|||mixed model repeated measures|||Week 24||0.294|-0.102|
71917739|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.205|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|0.007|0.404|||mixed model repeated measures|||Week 24||0.404|0.007|
71917740|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.197|STANDARD_ERROR_OF_MEAN|0.2135|||TWO_SIDED|90.0|-0.155|0.55|||mixed model repeated measures|||Week 36||0.550|-0.155|
71917741|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.423|STANDARD_ERROR_OF_MEAN|0.2152|||TWO_SIDED|90.0|0.068|0.779|||mixed model repeated measures|||Week 36||0.779|0.068|
71917742|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.052|STANDARD_ERROR_OF_MEAN|0.2644|||TWO_SIDED|90.0|-0.385|0.489|||mixed model repeated measures|||Week 48||0.489|-0.385|
71917743|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.2662|||TWO_SIDED|90.0|0.049|0.928|||mixed model repeated measures|||Week 48||0.928|0.049|
71917744|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.307|STANDARD_ERROR_OF_MEAN|0.3361|||TWO_SIDED|90.0|-0.248|0.862|||mixed model repeated measures|||Week 72||0.862|-0.248|
71917745|NCT04566445|143357554|SUPERIORITY||LS Mean Difference|0.503|STANDARD_ERROR_OF_MEAN|0.3392|||TWO_SIDED|90.0|-0.058|1.063|||mixed model repeated measures|||Week 72||1.063|-0.058|
71917746|NCT04566445|143357555|SUPERIORITY||LS Mean Difference|0.645|STANDARD_ERROR_OF_MEAN|0.4527|||TWO_SIDED|90.0|-0.103|1.393|||mixed model repeated measures|||Week 96||1.393|-0.103|
71917747|NCT04566445|143357555|SUPERIORITY||LS Mean Difference|0.838|STANDARD_ERROR_OF_MEAN|0.4577|||TWO_SIDED|90.0|0.081|1.594|||mixed model repeated measures|||Week 96||1.594|0.081|
71917748|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-2.6|1.7|||mixed model repeated measures|||Week 12||1.7|-2.6|
71917749|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-4.0|0.4|||mixed model repeated measures|||Week 12||0.4|-4.0|
71917750|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-4.1|0.8|||mixed model repeated measures|||Week 24||0.8|-4.1|
71917751|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|-5.3|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-7.7|-2.8|||mixed model repeated measures|||Week 24||-2.8|-7.7|
71684820|NCT04767529|142887909|SUPERIORITY|Week 96|Mean Difference (Net)|-3.4|STANDARD_ERROR_OF_MEAN|1.43||0.021|TWO_SIDED|95.0|-6.2|-0.5||Threshold for significance set at P\<0.05|Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 28 mg and placebo group|Treatment comparison of change from baseline (EFX 28 mg - placebo) in Liver Stiffness Measurement (kPa)||-0.5|-6.2|0.021
71684821|NCT04767529|142887909|SUPERIORITY|Week 96|Mean Difference (Net)|-6.6|STANDARD_ERROR_OF_MEAN|1.43|<|0.001|TWO_SIDED|95.0|-9.4|-3.7|||Mixed Models Analysis||LS Means, SEs, and p-values are from a MMRM with fixed effects of treatment, stratification factors, post-baseline visit, treatment-by-visit interaction, and baseline as a covariate for comparisons between the EFX 50 mg and placebo group|Treatment comparison of change from baseline (EFX 50 mg - placebo) in Liver Stiffness Measurement (kPa)||-3.7|-9.4|<0.001
71684822|NCT04942210|142887919|NON_INFERIORITY|The non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) was \>-5%|Difference in percentage of participants|0.3|||||TWO_SIDED|95.0|-1.2|3.2|||||95% CI of the difference was calculated from the Wilson score method without continuity correction.|||3.2|-1.2|
71684823|NCT04348500|142887985|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Chi-squared|||The null hypothesis is that there is no difference in the use of clazakizumab as a treatment compared to placebo in reducing or eliminating the incidence of severe adverse events among patients with COVID-19.||||0.10
71684824|NCT04348500|142887991|SUPERIORITY|||||||0.1||||||P-value was not adjusted.|Fisher Exact|||Null hypothesis is that there is no change in the need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo.||||0.10
71684825|NCT01410240|142887992|SUPERIORITY_OR_OTHER|||||||0.453|||||||one-sided, two-sample t-test|||||||0.453
71684826|NCT01410240|142887993|SUPERIORITY_OR_OTHER|||||||0.708|||||||one-sided, two-sample t-test|||||||0.708
71876891|NCT00232141|143272369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.4614||95.0|-0.34|0.75||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.75|-0.34|0.4614
71684827|NCT01410240|142887994|SUPERIORITY_OR_OTHER|||||||0.527|||||||one-sided, two-sample t-test|||||||0.527
71684828|NCT01410240|142887995|SUPERIORITY_OR_OTHER|||||||0.561|||||||one-sided Wilcoxon rank sum test|||||||0.561
71684829|NCT01410240|142887996|SUPERIORITY_OR_OTHER|||||||0.356|||||||one-sided Wilcoxon rank sum test|||||||0.356
71684830|NCT01410240|142887997|SUPERIORITY_OR_OTHER|||||||0.533|||||||one-sided Wilcoxon rank sum test|||||||0.533
71684831|NCT01410240|142887998|SUPERIORITY_OR_OTHER|||||||0.734|||||||two-sided Wilcoxon rank sum test|||||||0.734
71684832|NCT01410240|142888001|SUPERIORITY_OR_OTHER|||||||0.314|||||||two-sided Wilcoxon rank sum test|||||||0.314
71684833|NCT01410240|142888002|SUPERIORITY_OR_OTHER|||||||0.063|||||||two-sided Wilcoxon rank sum test|||||||0.063
71684834|NCT01410240|142888005|SUPERIORITY_OR_OTHER|||||||0.058|||||||two-sided Wilcoxon rank sum test|||||||0.058
71876892|NCT00232141|143272369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.31||0.1467||95.0|-0.16|1.06||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.06|-0.16|0.1467
71684835|NCT01410240|142888006|SUPERIORITY_OR_OTHER|||||||0.421|||||||two-sided Wilcoxon rank sum test|||||||0.421
71684836|NCT01410240|142888007|SUPERIORITY_OR_OTHER|||||||0.161|||||||two-sided Wilcoxon rank sum test|||||||0.161
71684837|NCT01410240|142888008|SUPERIORITY_OR_OTHER|||||||0.016|||||||two-sided Wilcoxon rank sum test|||||||0.016
71684838|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.534|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Pain||||0.534
71684839|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.269|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Stiffness||||0.269
71684840|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.693|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Physical Functioning||||0.693
71684841|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Average Score||||0.343
71684842|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Total Score||||0.343
71684843|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.978|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Pain||||0.978
71684844|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.709|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Stiffness||||0.709
71684845|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.594|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.594
71684846|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Average Score||||0.501
71684847|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Total Score||||0.501
71684848|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.171|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Pain||||0.171
71684849|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.077|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Stiffness||||0.077
71684850|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.026|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.026
71684851|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Average Score||||0.012
71684852|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Total Score||||0.012
71684853|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.126|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Pain||||0.126
71684854|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.044|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Stiffness||||0.044
71684855|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.153||||||Change Week 6: Physical Functioning|two-sided Wilcoxon rank sum test|||||||0.153
71684856|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Average Score||||0.134
71684857|NCT01410240|142888010|SUPERIORITY_OR_OTHER|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Total Score||||0.134
71684858|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.962|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning||||0.962
71684859|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.714|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Physical||||0.714
71684860|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.668|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Bodily Pain||||0.668
71684861|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.556|||||||two-sided Wilcoxon rank sum test|||Change Week 1: General Health||||0.556
71684862|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.705|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Vitality||||0.705
71684863|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.122|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Social Functioning||||0.122
71684864|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.254|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Emotional||||0.254
71684865|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.5|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Mental Health||||0.500
71684866|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.849|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Component Summary||||0.849
71684867|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||Change Week 1: Mental Component Summary||||0.959
71684868|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.574|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning||||0.574
71684869|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.524|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Physical||||0.524
71684870|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.049|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Bodily Pain||||0.049
71684871|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.447|||||||two-sided Wilcoxon rank sum test|||Change Week 2: General Health||||0.447
71684872|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.823|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Vitality||||0.823
71684873|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.661|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Social Functioning||||0.661
71684874|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.086|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Emotional||||0.086
71684875|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.635|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Health||||0.635
71684876|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.481|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Component Summary||||0.481
71684877|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.14|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Component Summary||||0.140
71684878|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.107|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Functioning||||0.107
71684879|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.298|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Physical||||0.298
71684880|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.071|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Bodily Pain||||0.071
71684881|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.94|||||||two-sided Wilcoxon rank sum test|||Change Week 6: General Health||||0.940
71684882|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.293|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Vitality||||0.293
71684883|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.265|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Social Functioning||||0.265
71684884|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.036|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Emotional||||0.036
71684885|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.307|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Health||||0.307
71684886|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.448|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Component Summary||||0.448
71684887|NCT01410240|142888012|SUPERIORITY_OR_OTHER|||||||0.255|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Component Summary||||0.255
71684888|NCT01410240|142888014|SUPERIORITY_OR_OTHER|||||||0.052|||||||two-sided Wilcoxon rank sum test|||||||0.052
71684889|NCT02776670|142888026|NON_INFERIORITY|Noninferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (Systane Balance-Refresh Optive Advanced/Optive Plus) was above the noninferiority margin of -1.0 second.|Mean Difference (Final Values)|0.13|||<|0.0001|TWO_SIDED|95.0|-0.341|0.601||p-value for testing noninferiority of Systane Balance with respect to Refresh Optive Advanced/Refresh Optive Plus is calculated for predefined noninferiority margin of -1.0 second.|Mixed model repeated measures (MMRM)|||||0.601|-0.341|<0.0001
71684890|NCT02776670|142888027|SUPERIORITY||Mean Difference (Final Values)|0.118||||0.31|TWO_SIDED|95.0|-0.349|0.585|||MMRM|||||0.585|-0.349|0.310
71684891|NCT02776670|142888029|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.618|TWO_SIDED|95.0|-6.4|4.7|||MMRM|||||4.7|-6.4|0.618
71684892|NCT01937884|142888047|SUPERIORITY|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71684893|NCT01937884|142888048|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71684894|NCT01937884|142888049|SUPERIORITY|||||||0.27|||||||t-test, 2 sided|Student's t-test on log-transformed change in IFABP.||||||0.27
71684895|NCT01937884|142888050|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|Student's t-test on log-transformed citrulline concentration on study day 5, by treatment group||||||0.04
71684896|NCT01937884|142888051|SUPERIORITY|||||||0.43|||||||t-test, 2 sided|Student's t-test on log-transformed percent change of claudin 3||||||0.43
71684897|NCT01937884|142888052|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71684898|NCT01937884|142888053|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
71684899|NCT01937884|142888054|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
71684900|NCT02722746|142888061|SUPERIORITY||percent difference|20.8||||0.165|TWO_SIDED|95.0|-8.9|47.3|||Z-test for proportions|||||47.3|-8.9|0.165
71684901|NCT02722746|142888061|SUPERIORITY||percent difference|14.4||||0.353|TWO_SIDED|95.0|-15.9|42.2|||Z-test for proportions|||||42.2|-15.9|0.353
71684902|NCT02722746|142888062|SUPERIORITY|||||||0.06|||||||Kruskal-Wallis|||For PACU spread||||0.06
71684903|NCT02722746|142888062|SUPERIORITY|||||||0.22|||||||Kruskal-Wallis|||For Pre-op spread||||0.22
71684904|NCT02722746|142888062|SUPERIORITY|||||||0.74|||||||Kruskal-Wallis|||For POD 1||||0.74
71684905|NCT02722746|142888063|SUPERIORITY|||||||0.551|||||||ANOVA|||||||0.551
71684906|NCT02722746|142888064|SUPERIORITY|||||||0.349|||||||Mixed Models Analysis|||||||0.349
71876893|NCT00232141|143272369|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.29||0.2819||95.0|-0.25|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.25|0.2819
71876894|NCT00232141|143272370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.26||0.8727||95.0|-0.55|0.46||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.46|-0.55|0.8727
71876895|NCT00232141|143272370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.28||0.6897||95.0|-0.65|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.65|0.6897
71876896|NCT00232141|143272370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7527||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.44|-0.60|0.7527
71876897|NCT00232141|143272370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.28||0.6394||95.0|-0.67|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.41|-0.67|0.6394
71876898|NCT00232141|143272370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.31||0.1188||95.0|-0.13|1.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||1.11|-0.13|0.1188
71876899|NCT00232141|143272370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.28||0.2685||95.0|-0.24|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.87|-0.24|0.2685
71876900|NCT00232141|143272371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.4991||95.0|-0.74|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.36|-0.74|0.4991
71876901|NCT00232141|143272371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.3||0.6094||95.0|-0.73|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.43|-0.73|0.6094
71917752|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-2.5|3.5|||mixed model repeated measures|||Week 36||3.5|-2.5|
71917753|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|-4.7|STANDARD_ERROR_OF_MEAN|1.8|||TWO_SIDED|90.0|-7.7|-1.7|||mixed model repeated measures|||Week 36||-1.7|-7.7|
71917754|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.14|||TWO_SIDED|90.0|-0.9|6.1|||mixed model repeated measures|||Week 48||6.1|-0.9|
71917755|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.12|||TWO_SIDED|90.0|-5.6|1.4|||mixed model repeated measures|||Week 48||1.4|-5.6|
71917756|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|2.24|||TWO_SIDED|90.0|1.0|8.4|||mixed model repeated measures|||Week 72||8.4|1.0|
71917757|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|2.2|||TWO_SIDED|90.0|-2.8|4.5|||mixed model repeated measures|||Week 72||4.5|-2.8|
71917758|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|7.1|STANDARD_ERROR_OF_MEAN|2.7|||TWO_SIDED|90.0|2.7|11.6|||mixed model repeated measures|||Week 96||11.6|2.7|
71917759|NCT04566445|143357560|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|2.68|||TWO_SIDED|90.0|-1.8|7.1|||mixed model repeated measures|||Week 96||7.1|-1.8|
71917760|NCT02421939|143357565|OTHER||Hazard Ratio (HR)|0.637||||0.0004|TWO_SIDED|95.0|0.49|0.83||1-sided P-value|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm|Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.||0.830|0.490|0.0004
71917761|NCT02421939|143357567|OTHER||Hazard Ratio (HR)|0.793||||0.0415|TWO_SIDED|95.0|0.577|1.089||1-sided P-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT||1.089|0.577|0.0415
71917762|NCT02421939|143357568|OTHER||Adjusted Treatment Difference|10.6||||0.0106|TWO_SIDED|95.0|2.8|18.4||Stratified P-value|Cochran-Mantel-Haenszel|||Based on stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Treatment difference = gilteritinib -chemotherapy.||18.4|2.8|0.0106
71876902|NCT00232141|143272371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.26||0.3669||95.0|-0.76|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.28|-0.76|0.3669
71876903|NCT00232141|143272371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.26||0.7641||95.0|-0.43|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.59|-0.43|0.7641
71876904|NCT00232141|143272371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.27||0.9428||95.0|-0.51|0.55||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.55|-0.51|0.9428
71876905|NCT00232141|143272371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.26||0.9508||95.0|-0.52|0.49||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.49|-0.52|0.9508
71876906|NCT00232141|143272372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.25||0.0073||95.0|-1.18|-0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||-0.19|-1.18|0.0073
71876907|NCT00232141|143272372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.3||0.2202||95.0|-0.96|0.22||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.22|-0.96|0.2202
71876908|NCT00232141|143272372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.29||0.1824||95.0|-0.95|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.18|-0.95|0.1824
71876909|NCT00232141|143272372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.3||0.1872||95.0|-0.98|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.19|-0.98|0.1872
71876910|NCT00232141|143272372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.32||0.4374||95.0|-0.38|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.88|-0.38|0.4374
71876911|NCT00232141|143272372|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.3||0.4406||95.0|-0.36|0.82||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.82|-0.36|0.4406
71876912|NCT00232141|143272373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.27||0.2277||95.0|-0.86|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1||0.21|-0.86|0.2277
71876913|NCT00232141|143272373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8407||95.0|-0.71|0.58||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2||0.58|-0.71|0.8407
71876914|NCT00232141|143272373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8809||95.0|-0.62|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6||0.53|-0.62|0.8809
71876915|NCT00232141|143272373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.29||0.6288||95.0|-0.72|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10||0.43|-0.72|0.6288
71876916|NCT00232141|143272373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.3||0.9739||95.0|-0.59|0.61||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14||0.61|-0.59|0.9739
71684907|NCT02722746|142888065|SUPERIORITY|||||||0.18|||||||Fisher Exact|||For Pruritis||||0.18
71684908|NCT02722746|142888065|SUPERIORITY|||||||0.44|||||||Fisher Exact|||For Nausea/Vomiting||||0.44
71684909|NCT02722746|142888065|SUPERIORITY|||||||0.74|||||||Fisher Exact|||For Respirartory Depression||||0.74
71684910|NCT02722746|142888069|SUPERIORITY|||||||0.524|||||||ANOVA|||For SBP||||0.524
71684911|NCT02722746|142888069|SUPERIORITY|||||||0.585|||||||ANOVA|||For DBP||||0.585
71684912|NCT02722746|142888069|SUPERIORITY|||||||0.199|||||||ANOVA|||For MAP||||0.199
71684913|NCT02722746|142888070|SUPERIORITY|||||||0.231|||||||Mixed Models Analysis|||||||0.231
71684914|NCT02722746|142888071|SUPERIORITY|||||||0.016|||||||ANOVA|||||||0.016
71684915|NCT02722746|142888072|SUPERIORITY|||||||0.055|||||||ANOVA|||||||0.055
71684916|NCT02722746|142888073|SUPERIORITY|||||||0.567|||||||ANOVA|||||||0.567
71684917|NCT03706469|142888074|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of Geometric Mean Ratio (GMR)|83.6|||||TWO_SIDED|90.0|74.5|93.8||||||||93.80|74.50|
71684918|NCT03706469|142888074|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|102.22|||||TWO_SIDED|90.0|91.1|114.7||||||||114.70|91.10|
71684919|NCT03706469|142888074|EQUIVALENCE|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.73|||||TWO_SIDED|90.0|152.55|195.58||||||||195.58|152.55|
71684920|NCT03706469|142888075|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|84.29|||||TWO_SIDED|90.0|73.92|96.11||||||||96.11|73.92|
71684921|NCT03706469|142888075|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.61|||||TWO_SIDED|90.0|88.88|111.63||||||||111.63|88.88|
71684922|NCT03706469|142888075|EQUIVALENCE|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.7|||||TWO_SIDED|90.0|149.07|200.09||||||||200.09|149.07|
71876917|NCT00232141|143272373|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.29||0.8926||95.0|-0.61|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint||0.53|-0.61|0.8926
71876918|NCT00232141|143272376|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7136||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.7136
71876919|NCT00232141|143272377|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729||95.0||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||||||0.6729
71876920|NCT02113579|143272431|SUPERIORITY_OR_OTHER||Success rate difference (%)|24.7|||<|0.001|TWO_SIDED|||||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05) with estimated difference of \>= 20%, testing proceeded to Mean Cold Air Stimulus VAS Score at Week 4. Family-wise error was controlled at 0.05.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 4, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||<0.001
71876921|NCT02113579|143272432|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.27|STANDARD_ERROR_OF_MEAN|2.239|<|0.001|TWO_SIDED|95.0|-18.68|-9.87||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Tactile Sensitivity Score at Week 4. Family-wise error was controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-9.87|-18.68|<0.001
71876922|NCT02113579|143272433|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|13.45|STANDARD_ERROR_OF_MEAN|1.844|<|0.001|TWO_SIDED|95.0|9.83|17.08||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p\<0.05), testing proceeded to Mean Cold Air Stimulus VAS Score at Week 2 and Mean Tactile Sensitivity Score at Week 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||17.08|9.83|<0.001
71876923|NCT02113579|143272434|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.67|STANDARD_ERROR_OF_MEAN|1.809|<|0.001|TWO_SIDED|95.0|-11.23|-4.11||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-4.11|-11.23|<0.001
71876924|NCT02113579|143272435|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|0.975|<|0.001|TWO_SIDED|95.0|2.78|6.62||Per statistical analysis plan, Hochberg's method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.62|2.78|<0.001
71876925|NCT02113579|143272436|SUPERIORITY_OR_OTHER||Success rate difference (%)|15.44||||0.002|TWO_SIDED|||||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 2, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.||||0.002
71876926|NCT02113579|143272437|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.67|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-9.92|-3.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-3.43|-9.92|<0.001
71876927|NCT02113579|143272438|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-11.52|STANDARD_ERROR_OF_MEAN|1.92|<|0.001|TWO_SIDED|95.0|-15.3|-7.75||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-7.75|-15.30|<0.001
71876928|NCT02113579|143272439|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.422||0.023|TWO_SIDED|95.0|-6.04|-0.45||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.45|-6.04|0.023
71876929|NCT02113579|143272440|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-7.61|STANDARD_ERROR_OF_MEAN|1.873|<|0.001|TWO_SIDED|95.0|-11.29|-3.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||-3.93|-11.29|<0.001
71917763|NCT02421939|143357569|OTHER||Hazard Ratio (HR)|0.889||||0.6654|TWO_SIDED|95.0|0.506|1.563||Unstratified p-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of \< 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|The LFS was analyzed for participants who achieved remission using the stratified log-rank test with strata to control for response to first-line AML therapy and preselected salvage chemotherapy. Duration of LFS was based on Kaplan-Meier estimates.||1.563|0.506|0.6654
71876930|NCT00088907|143272441|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Log Rank|||||||0.60
71876931|NCT00088907|143272442|SUPERIORITY_OR_OTHER|||||||0.19|||||||Log Rank|||||||0.19
71876932|NCT03426787|143272452|SUPERIORITY||Mean Difference (Final Values)|-12.30216|||<|0.001|TWO_SIDED|95.0|-18.95|-5.6531|||t-test, 2 sided|||||-5.6531|-18.95|<0.001
71876933|NCT03426787|143272453|SUPERIORITY||Mean Difference (Final Values)|-0.4717||||0.0463|TWO_SIDED|95.0|-0.9355|-0.00793|||t-test, 2 sided|||||-0.00793|-0.9355|0.0463
71876934|NCT03426787|143272454|SUPERIORITY||Median Difference (Final Values)|-1.936|||>|0.05|TWO_SIDED|95.0|-7.4086|3.5365|||t-test, 2 sided|||||3.5365|-7.4086|>0.05
71876935|NCT02217436|143272456|SUPERIORITY|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
71876936|NCT02217436|143272457|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71876937|NCT01920594|143272469|SUPERIORITY||Mean Difference (Final Values)|2228.14||||0.082|TWO_SIDED|95.0|-292.84|4749.11|||ANCOVA||The point estimate was calculated as least square (LS) mean difference (final values) of S-100B Protein \[test\] and S-100B Protein \[reference\].|||4749.11|-292.84|0.0820
71876938|NCT01920594|143272470|SUPERIORITY||Mean Difference (Final Values)|777.95||||0.1997|TWO_SIDED|95.0|-424.04|1979.94|||ANCOVA||The point estimate was calculated as LS mean difference (final values) of GFAP \[test\] and GFAP \[reference\].|||1979.94|-424.04|0.1997
71876939|NCT01920594|143272476|SUPERIORITY||Estimate of comparison (Ratio)|1.77||||0.153|TWO_SIDED|95.0|0.8|3.9|||ANOVA||The point estimate was calculated as Geometric mean ratio of S-100B\[test\] and S-100B\[reference\].|||3.90|0.80|0.1530
71876940|NCT01920594|143272477|SUPERIORITY||Estimate of comparison (Ratio)|3.13||||0.1377|TWO_SIDED|95.0|0.69|14.26|||ANOVA||The point estimate was calculated as Geometric mean ratio of GFAP\[test\] and GFAP\[reference\].|||14.26|0.69|0.1377
71876941|NCT01920594|143272478|SUPERIORITY||Mean Difference (Final Values)|34.56|||<|0.0001|TWO_SIDED|95.0|21.95|47.17|||ANCOVA||The point estimate was calculated as LS mean difference final values of Erythropoietin\[test\] and Erythropoietin\[reference\].|||47.17|21.95|<.0001
71876942|NCT01920594|143272479|SUPERIORITY||Mean Difference (Final Values)|0.54||||0.2404|TWO_SIDED|95.0|-0.37|1.45|||ANCOVA||The point estimate was calculated as LS mean difference final values of Lactate Dehydrogenase\[test\] and Lactate Dehydrogenase\[reference\].|||1.45|-0.37|0.2404
71876943|NCT01920594|143272480|SUPERIORITY||Mean Difference (Final Values)|925.88||||0.0526|TWO_SIDED|95.0|-10.73|1862.49|||ANCOVA||The point estimate was calculated as LS mean difference final values of Tau Protein\[test\] and Tau Protein\[reference\].|||1862.49|-10.73|0.0526
71876944|NCT01920594|143272481|SUPERIORITY||Mean Difference (Final Values)|4.11||||0.0893|TWO_SIDED|95.0|-0.65|8.87|||ANCOVA||The point estimate was calculated as LS mean difference final values of Neuron Specific Enolase\[test\] and Neuron Specific Enolase\[reference\].|||8.87|-0.65|0.0893
71876945|NCT01920594|143272486|SUPERIORITY||Ratio of geometric mean|1.84||||0.5012|TWO_SIDED|95.0|0.3|11.32|||ANOVA|||For Troponin I||11.32|0.30|0.5012
71876946|NCT01920594|143272486|SUPERIORITY||Ratio of geometric mean|0.75||||0.8053|TWO_SIDED|95.0|0.07|8.57|||ANOVA|||For Troponin T||8.57|0.07|0.8053
71876947|NCT02039726|143272498|OTHER||Hazard Ratio (HR)|0.758||||0.0185|TWO_SIDED|95.0|0.584|0.983|||P-value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||0.983|0.584|0.0185
71876948|NCT02039726|143272499|OTHER||Hazard Ratio (HR)|0.898||||0.2034|TWO_SIDED|95.0|0.697|1.157|||P value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).||1.157|0.697|0.2034
71876949|NCT00813319|143272511|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion condition||||>.05
71876950|NCT00813319|143272512|SUPERIORITY_OR_OTHER||||||=|0.52|||||||Chi-squared|||||||=.52
71917764|NCT02421939|143357570|OTHER||Hazard Ratio (HR)|0.206||||0.1189|TWO_SIDED|95.0|0.022|1.886||Unstratified|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio \< 1 indicates a reduction in hazard rate in favor of gilteritinib arm.|||1.886|0.022|0.1189
71917765|NCT02421939|143357571|OTHER||Treatment difference|32.5|||<|0.0001|TWO_SIDED|95.0|22.3|42.6||Unstratified 2-sided P-value|2-sided Fisher's exact test|||Treatment difference = gilteritinib - chemotherapy. The 95% CIs were asymptotic confidence limits using the normal approximation to the binomial distribution.||42.6|22.3|<0.0001
71684923|NCT03706469|142888076|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|79.14|||||TWO_SIDED|90.0|67.36|92.99||||||||92.99|67.36|
71684924|NCT03706469|142888076|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.8|||||TWO_SIDED|90.0|84.94|117.27||||||||117.27|84.94|
71876951|NCT00813319|143272513|SUPERIORITY_OR_OTHER||||||=|0.12|||||||Chi-squared|Degrees of freedom = 2||This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)||||=.12
71876952|NCT02012296|143272514|SUPERIORITY|||||||0.83|||||||Log Rank|||||||0.83
71876953|NCT02012296|143272515|SUPERIORITY|||||||0.21|||||||Log Rank|||||||0.21
71876954|NCT02012296|143272518|SUPERIORITY|||||||0.0012|||||||t-test, 2 sided|||||||0.0012
71876955|NCT02012296|143272519|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71876956|NCT02012296|143272520|SUPERIORITY|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71876957|NCT02615470|143272524|SUPERIORITY||||||=|0.202||||||A priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.202
71876958|NCT02615470|143272525|SUPERIORITY|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||||||0.048
71876959|NCT02615470|143272526|SUPERIORITY||||||=|0.322||||||a priori alpha = 0.05|Wilcoxon (Mann-Whitney)|||||||=0.322
71876960|NCT01817907|143272528|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||||||0.52
71876961|NCT01830855|143272563|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.03|||||TWO_SIDED|95.0|0.93|1.14||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.14|0.93|
71876962|NCT01830855|143272563|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.02|||||TWO_SIDED|95.0|0.92|1.13||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.13|0.92|
71876963|NCT01830855|143272563|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.88|1.12||||||PMB80 \[A22\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.||1.12|0.88|
71876964|NCT01830855|143272563|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.85|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.85|
71876965|NCT01830855|143272563|SUPERIORITY_OR_OTHER||Ratio of GMTs|0.95|||||TWO_SIDED|95.0|0.86|1.06||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.||1.06|0.86|
71876966|NCT01830855|143272563|SUPERIORITY_OR_OTHER||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.88|1.14||||||PMB2948 \[B24\]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948||1.14|0.88|
71876967|NCT03034460|143272630|SUPERIORITY||||||=|0.158|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \[n=48\] versus CD5024 1% Cream Matched Placebo \[n=48\]).||||= 0.158
71876968|NCT03034460|143272630|SUPERIORITY||||||=|0.002|||||||Wilcoxon rank signed test|||This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \[n=22\] versus Adapalene Benzoyl Peroxyde Matched Placebo \[n=22\]).||||= 0.002
71876969|NCT02645760|143272656|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.26 points in mean 11-point NRS pain score between core stabilization exercise and conventional treatment from baseline to week 7.||||<0.001
71876970|NCT02645760|143272657|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.68 points in mean disability score (RMDQ score) between core stabilization exercise and conventional treatment from baseline to week 7.||||0.009
71876971|NCT02645760|143272658|SUPERIORITY_OR_OTHER|||||||0.013|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.79 centimeter in mean range of motion between core stabilization exercise and conventional treatment from baseline to week 7.||||0.013
71876972|NCT02645760|143272659|SUPERIORITY_OR_OTHER|||||||0.012|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.30 centimeter in mean repositioning error between core stabilization exercise and conventional treatment from baseline to week 7.||||0.012
71876973|NCT01509079|143272663|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANOVA|||||||0.38
71876974|NCT00314249|143272698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.38||||||95.0|-8.56|-4.19|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-4.19|-8.56|
71876975|NCT00314249|143272699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||||95.0|-0.69|-0.38|||ANOVA|||This parameter was analyzed using an ANOVA model with treatment group and study center as factors.||-0.38|-0.69|
71876976|NCT00314249|143272700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||||95.0|-3.27|-0.11|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||-0.11|-3.27|
71684925|NCT03706469|142888076|EQUIVALENCE|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|173.3|||||TWO_SIDED|90.0|150.05|200.16||||||||200.16|150.05|
71684926|NCT00981058|142888078|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.842||||0.012|TWO_SIDED|95.0|0.736|0.962|||Log Rank|||||0.962|0.736|0.0120
71684927|NCT00981058|142888079|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.851||||0.0201|TWO_SIDED|95.0|0.743|0.975|||Log Rank|||||0.975|0.743|0.0201
71876977|NCT00314249|143272701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06|||<|0.001||95.0|1.45|2.94||Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.||2.94|1.45|<0.001
71876978|NCT00314249|143272702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.86|||<|0.001||95.0|1.38|2.51||Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.||2.51|1.38|<0.001
71876979|NCT00314249|143272703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.65||||||95.0|0.86|2.44|||ANCOVA|||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.||2.44|0.86|
71876980|NCT03334409|143272732|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71876981|NCT03334409|143272733|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
71876982|NCT03334409|143272734|SUPERIORITY|||||||0.08|||||||Log Rank|||||||0.08
71876983|NCT03334409|143272735|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71876984|NCT03334409|143272736|SUPERIORITY|||||||0.18|||||||Kruskal-Wallis|||||||0.18
71876985|NCT03334409|143272737|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71876986|NCT01892306|143272778|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||.02
71876987|NCT01892306|143272779|SUPERIORITY_OR_OTHER|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.02
71876988|NCT01892306|143272780|SUPERIORITY_OR_OTHER|||||||0.24|||||||Mixed Models Analysis|||Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.||||0.24
71684928|NCT00981058|142888080|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.12||||0.3997|TWO_SIDED|95.0|0.86|1.45|||Cochran-Mantel-Haenszel|||||1.45|0.86|0.3997
71876989|NCT01892306|143272781|OTHER|||||||0.62|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.||||.62
71876990|NCT01892306|143272781|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores||||.03
71876991|NCT01892306|143272782|OTHER|||||||0.95|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.95
71876992|NCT01892306|143272782|OTHER|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.||||0.03
71876993|NCT01892306|143272783|OTHER|||||||0.87|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.87
71876994|NCT01892306|143272783|OTHER|||||||0.37|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores||||0.37
71876995|NCT01892306|143272784|OTHER|||||||0.17|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.||||0.17
71684929|NCT00981058|142888081|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.844||||0.0061|TWO_SIDED|95.0|0.747|0.953|||Log Rank|||||0.953|0.747|0.0061
71684930|NCT02667587|142888087|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||||1.25|0.90|
71684931|NCT02667587|142888088|SUPERIORITY||Cox Proportional Hazard|1.12||||0.3402|TWO_SIDED|96.39|0.87|1.43|||Log Rank|||All Randomized No Baseline Corticosteroids Participants||1.43|0.87|0.3402
71684932|NCT02667587|142888088|SUPERIORITY||Cox Proportional Hazard|1.1|||||TWO_SIDED|95.0|0.91|1.33||||||All Randomized Participants||1.33|0.91|
71684933|NCT02667587|142888092|SUPERIORITY||Cox Proportional Hazard|1.18|||||TWO_SIDED|95.0|0.99|1.4||||||||1.40|0.99|
71876996|NCT01892306|143272784|OTHER|||||||0.04|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores||||.04
71876997|NCT01892306|143272785|OTHER|||||||0.007|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||0.007
71876998|NCT01892306|143272785|OTHER|||||||0.14|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.||||.14
71876999|NCT00038727|143272840|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.87|TWO_SIDED|95.0|0.81|1.28|||Log Rank|||||1.28|0.81|0.87
71877000|NCT00038727|143272840|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||||1.25|0.79|0.95
71877001|NCT00223678|143272849|SUPERIORITY_OR_OTHER|||||||0.849|||||||Log Rank|||||||0.849
71877002|NCT00523718|143272850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||Chi-squared|||||||.24
71917766|NCT02421939|143357572|OTHER||Treatment Difference|10.2||||0.0333|TWO_SIDED|95.0|1.2|19.1||Unstratified 2-sided P-value.|2-sided Fisher's exact test|Treatment difference = gilteritinib - chemotherapy.||||19.1|1.2|0.0333
71917767|NCT02421939|143357573|OTHER||Least Squares Mean Difference|-1.2567||||0|||||||ANCOVA|||C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.0000
71684934|NCT02667587|142888093|SUPERIORITY||Cox Proportional Hazard|1.06|||||TWO_SIDED|95.0|0.89|1.26|||Log Rank|||||1.26|0.89|
71684935|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.055|||||TWO_SIDED|95.0|-0.067|0.178||||||Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2||0.178|-0.067|
71917768|NCT02421939|143357573|OTHER||Least Squares Mean Difference|0.1574||||0.8037|||||||ANCOVA|||C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.||||0.8037
71684936|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.024|||||TWO_SIDED|95.0|-0.102|0.151||||||Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3||0.151|-0.102|
71877003|NCT02060383|143272854|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|95.0|-0.63|0.08|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c \<7% vs ≥7%) as fixed effects.|All Patients||0.08|-0.63|
71877004|NCT02060383|143272854|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|95.0|-0.96|0.95|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Cushing's Disease||0.95|-0.96|
71917769|NCT02421939|143357574|OTHER||Adjusted Treatment Difference,|18.6|||<|0.0171|TWO_SIDED|95.0|9.8|27.4||Stratified 1-sided P-value.|Cochran-Mantel-Haenszel|||Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.||27.4|9.8|<0.0171
71917770|NCT01029691|143357590|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||unadjusted systolic blood pressure at baseline between groups||||0.45
71684937|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.08|||||TWO_SIDED|95.0|-0.204|0.045||||||Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1||0.045|-0.204|
71684938|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.174|||||TWO_SIDED|95.0|0.009|0.34||||||Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2||0.340|0.009|
71684939|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.12|||||TWO_SIDED|95.0|-0.297|0.056||||||Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3||0.056|-0.297|
71684940|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.054|||||TWO_SIDED|95.0|-0.225|0.117||||||Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1||0.117|-0.225|
71684941|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.058|||||TWO_SIDED|95.0|-0.068|0.184||||||Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2||0.184|-0.068|
71917771|NCT01029691|143357590|SUPERIORITY|||||||0.66|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at baseline between groups||||0.66
71917772|NCT01029691|143357590|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Unadjusted systolic blood pressure at week 1||||0.61
71917773|NCT01029691|143357590|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at week 1||||0.75
71917774|NCT01029691|143357591|SUPERIORITY|||||||0.085|||||||Chi-squared|||||||0.085
71917775|NCT01029691|143357592|SUPERIORITY|||||||0.012||||||Unadjusted|t-test, 2 sided|||||||0.012
71917776|NCT01029691|143357596|SUPERIORITY|||||||0.4|||||||Fisher Exact|||||||0.4
71917777|NCT00137267|143357641|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71917778|NCT00137267|143357642|SUPERIORITY_OR_OTHER|||||||0.152|TWO_SIDED||||||Chi-squared|||||||0.152
71917779|NCT00853112|143357728|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-115.0|STANDARD_DEVIATION|98.36||0.12|TWO_SIDED|95.0|-371.5|-1.1|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and standard deviation (SD) from the Bayesian analysis.||-1.1|-371.5|0.120
71684942|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.042|||||TWO_SIDED|95.0|-0.167|0.082||||||Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3||0.082|-0.167|
71877005|NCT02060383|143272854|OTHER|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|95.0|-0.74|0.02|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c \<7% vs ≥7%) as fixed effects.|Acromegaly||0.02|-0.74|
71877006|NCT03523728|143272880|SUPERIORITY||Relative difference|21.32|||=|0.1367|TWO_SIDED|95.0|-5.77|58.22|||linear mixed effect model|||||58.22|-5.77|=0.1367
71877007|NCT03523728|143272880|SUPERIORITY||Relative difference|0.34|||=|0.9812|TWO_SIDED|95.0|-24.57|33.36|||linear mixed effect model|||||33.36|-24.57|=0.9812
71877008|NCT03523728|143272881|SUPERIORITY||Relative difference|101.32|||=|0.0005|TWO_SIDED|95.0|35.63|233.72|||linear mixed effect model|||||233.72|35.63|=0.0005
71877009|NCT03523728|143272881|SUPERIORITY||Relative difference|104.17|||=|0.0002|TWO_SIDED|95.0|39.54|236.45|||linear mixed effect model|||||236.45|39.54|=0.0002
71877010|NCT03523728|143272882|SUPERIORITY||Relative difference|51.01|||=|0.0197|TWO_SIDED|95.0|7.01|125.45|||linear mixed effect model|||||125.45|7.01|=0.0197
71877011|NCT03523728|143272882|SUPERIORITY||Relative difference|46.36|||=|0.0337|TWO_SIDED|95.0|3.21|119.01|||linear mixed effect model|||||119.01|3.21|=0.0337
71877012|NCT03523728|143272884|SUPERIORITY||Least square mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.23|=|0.6374|TWO_SIDED|95.0|-0.342|0.556|||Mixed effect model with repeated measure|||||0.556|-0.342|=0.6374
71877013|NCT03523728|143272884|SUPERIORITY||Least square mean difference|-0.25|STANDARD_ERROR_OF_MEAN|0.22|=|0.256|TWO_SIDED|95.0|-0.689|0.185|||Mixed effect model with repeated measure|||||0.185|-0.689|=0.2560
71877014|NCT03523728|143272885|SUPERIORITY||Least square mean difference|-0.11|STANDARD_ERROR_OF_MEAN|0.42|=|0.79|TWO_SIDED|95.0|-0.971|0.747|||Mixed effect model with repeated measure|||||0.747|-0.971|=0.7900
71877015|NCT03523728|143272885|SUPERIORITY||Least square mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.32|=|0.6322|TWO_SIDED|95.0|-0.808|0.5|||Mixed effect model with repeated measure|||||0.500|-0.808|=0.6322
71877016|NCT03523728|143272886|SUPERIORITY||Least square mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.6245|TWO_SIDED|95.0|-0.506|0.839|||Mixed effect model with repeated measure|||||0.839|-0.506|=0.6245
71877017|NCT03523728|143272886|SUPERIORITY||Least square mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.33|=|0.2567|TWO_SIDED|95.0|-1.044|0.281|||Mixed effect model with repeated measure|||||0.281|-1.044|=0.2567
71877018|NCT03523728|143272887|SUPERIORITY||Least square mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.68|=|0.2023|TWO_SIDED|95.0|-2.232|0.485|||Mixed effect model with repeated measure|||||0.485|-2.232|=0.2023
71877019|NCT03523728|143272887|SUPERIORITY||Least square mean difference|-0.54|STANDARD_ERROR_OF_MEAN|0.53|=|0.3205|TWO_SIDED|95.0|-1.61|0.537|||Mixed effect model with repeated measure|||||0.537|-1.610|=0.3205
71877020|NCT00621751|143272900|OTHER||Median Difference (Final Values)|36.7||||0.6|TWO_SIDED|||||CBZ (up to 800 mg daily) vs placebo significantly improves behavior (Rasch NPI irritability \& aggression rated by observer) baseline to day-42 among individuals \>6 months post-traumatic brain injury and moderate-severe irritability.|ANCOVA|||The primary outcome was a composite measure of observer-rated NPI-I \& NPI-A domains transformed to a Rasch logit scale ranging 0 (best) to 100 (worse) units (i.e., observer-rated NPI-I/A Rasch construct scores). Mean day-42 observer-rated NPI-I/A Rasch construct scores were compared between the placebo vs. carbamazepine groups using ANCOVA with baseline score as covariate.||||0.60
71877021|NCT00621751|143272901|OTHER|A prespecified secondary analysis compared proportions of participants that experienced a decrease of \> 1 MCID in the NPI-I/A Rasch construct score (i.e., participants that are considered to have meaningful reduction in irritability/aggression) from baseline to day-42 between the groups using a chi-square test. MCID was defined as 0.5 times the standard deviation of baseline scores.|||||<|0.05|||||||ANCOVA|||||||< .05
71877022|NCT01809132|143272931|SUPERIORITY|||||||0.3|||||||Log Rank|||||||.30
71877023|NCT01809132|143272932|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|||the observational subject was lost to follow-up||||.42
71877024|NCT01809132|143272933|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|||||||.75
71877025|NCT01809132|143272934|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||.17
71877026|NCT03349775|143272935|SUPERIORITY||Median Difference (Final Values)|-2.57|STANDARD_DEVIATION|5.14||0.35|TWO_SIDED|95.0|-8.32|3.18|||t-test, 2 sided|||||3.18|-8.32|0.35
71877027|NCT03349775|143272936|SUPERIORITY||Median Difference (Final Values)|1.13|STANDARD_DEVIATION|2.13||0.37|TWO_SIDED|95.0|-1.65|3.92|||t-test, 2 sided|||||3.92|-1.65|0.37
71877028|NCT01516970|143272938|SUPERIORITY_OR_OTHER|||||||0.2434||||||The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel \[CMH\]-Test) with p-value: 0.2434|Cochran-Mantel-Haenszel|||||||0.2434
71877029|NCT01516970|143272939|SUPERIORITY_OR_OTHER|||||||0.8839||||||The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.|Fisher Exact|||||||0.8839
71877030|NCT01756040|143272943|OTHER|||||||0.932||||||not adjusted for multiple comparisons. The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||We hypothesized that intestinal permeability as measured by urinary lactulose/rhamnose ratio would be higher in the lower gestational age (\<29 weeks) compared to the more mature infants (≥29 weeks gestation) at postnatal age 7-10 days.||||0.932
71877031|NCT01756040|143272944|OTHER|||||||0.316|||||||t-test, 2 sided|||We hypothesized that stool A1AT would be higher in infants with high IP as measured by urinary La/Rh compared to those with low IP.||||0.316
71877032|NCT01756040|143272945|OTHER|||||||0.011||||||The significance value was estimated using Bayesian goodness-of-fit p-value to assess the significance of the association of the relative abundance of Clostridiales and IP categories. P value \<0.05 was considered significant.|Bayesian goodness of fit|||||||0.011
71877033|NCT01756040|143272946|OTHER|||||||0.0023|||||||t-test, 2 sided|||We hypothesized that infants with normal barrier function (La/Rh ratio ≤0.05) would have been fed breastmilk for longer duration than infants with impaired barrier function (La/Rh\>0.05).||||0.0023
71877034|NCT01756040|143272947|OTHER|||||||1|||||||Chi-squared|||||||1.0
71877035|NCT01756040|143272948|OTHER|||||||0.461||||||A priori threshold \<0.05|Chi-squared|||||||0.461
71684943|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.016|||||TWO_SIDED|95.0|-0.144|0.113||||||Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1||0.113|-0.144|
71684944|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.144|||||TWO_SIDED|95.0|-0.006|0.295||||||Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2||0.295|-0.006|
71877036|NCT01756040|143272949|OTHER|||||||0.019|||||||t-test, 2 sided|||We hypothesized that infants with impaired barrier function as measured by high urinary La/Rh (\>0.05) ratio at 7-10 days of age would require longer time to reach full enteral feedings than infants with normal barrier function (La/Rh≤0.05)||||0.019
71684945|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.06|||||TWO_SIDED|95.0|-0.207|0.088||||||Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3||0.088|-0.207|
71684946|NCT01134263|142888094|EQUIVALENCE|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.085|||||TWO_SIDED|95.0|-0.242|0.073||||||Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1||0.073|-0.242|
71917780|NCT00853112|143357728|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-170.6|STANDARD_DEVIATION|107.84||0.25|TWO_SIDED|95.0|-409.2|-7.1|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-7.1|-409.2|0.250
71917781|NCT00853112|143357728|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-240.2|STANDARD_DEVIATION|109.28||0.485|TWO_SIDED|95.0|-444.8|-33.8|||Bayesian 4-parameter Emax model.|||The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-33.8|-444.8|0.485
71917782|NCT00853112|143357728|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-327.9|STANDARD_DEVIATION|92.41||0.81|TWO_SIDED|95.0|-492.9|-148.0|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-148.0|-492.9|0.810
71684947|NCT01134263|142888095|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.091|||||TWO_SIDED|95.0|-0.009|0.192||||||Dengue Virus Serotype 1||0.192|-0.009|
71684948|NCT01134263|142888095|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|0.334|||||TWO_SIDED|95.0|0.202|0.466||||||Dengue Virus Serotype 2||0.466|0.202|
71877037|NCT00892177|143272956|SUPERIORITY_OR_OTHER_LEGACY||Maximum Tolerated Dose (mg)|100.0|||||TWO_SIDED|||||||||||||
71917783|NCT00853112|143357728|SUPERIORITY_OR_OTHER||Predicted Mean Difference|-379.4|STANDARD_DEVIATION|73.61||0.974|TWO_SIDED|95.0|-520.6|-238.8|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of \>=240 dyne\*s\*m\^2/cm\^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.||-238.8|-520.6|0.974
71684949|NCT01134263|142888095|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.076|||||TWO_SIDED|95.0|-0.173|0.021||||||Dengue Virus Serotype 3||0.021|-0.173|
71877038|NCT00892177|143272957|SUPERIORITY_OR_OTHER_LEGACY||Difference|0.1||||0.22|TWO_SIDED|95.0|-0.052|0.262|||Chi-squared, Corrected||Difference in proportion|||0.262|-0.052|0.22
71877039|NCT00892177|143272959|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92||||0.7|TWO_SIDED|95.0|0.61|1.4|||Kaplan Meier|||||1.4|0.61|0.7
71877040|NCT00892177|143272960|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.14||||0.52|TWO_SIDED|95.0|0.76|1.7|||Kaplan Meier|||||1.7|0.76|0.52
71877041|NCT00892177|143272961|SUPERIORITY||Mean Difference (Final Values)|-0.223||||0.96|TWO_SIDED||||||Mixed Models Analysis||The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.|||||0.96
71877042|NCT00892177|143272962|SUPERIORITY|||||||0.6325|||||||Fisher Exact|||||||0.6325
71877043|NCT02267603|143272967|OTHER|The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.||||||||||||||||The protocol was designed w/ a standard Simon 2 stage design. Null hypothesis that true response rate is 5% was tested against a 1-sided alternative. In stage 1, 9 patients were accrued. If no responses in these 9 patients, study was to stop. Otherwise,15 more patients were to be accrued for a total of 24 patients. Study was amended to increase number of patients to 50, following discussion w/ pharmaceutical collaborator and FDA.|ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.|||
71877044|NCT03933397|143272993|SUPERIORITY|||||||0.909|||||||Regression, Linear|||||||0.909
71877045|NCT01572675|143273029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for duration of prescription at enrollment||||<0.001
71877046|NCT01572675|143273029|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||p-student|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for duration of prescription at enrollment||||<0.001
71877047|NCT01572675|143273034|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Chi-squared|||Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.||||<0.001
71877048|NCT01572675|143273037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.104
71877049|NCT01572675|143273037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0049|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.0049
71877050|NCT01572675|143273037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.618|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for controlled BP (SBP \<140 mmHg and DBP \<90 mmHg) at study entry||||0.618
71877051|NCT01572675|143273038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for medical history of arterial hypertension||||0.012
71877052|NCT01572675|143273038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for medical history of arterial hypertension||||0.175
71877053|NCT01572675|143273040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.701|||||||Chi-squared|||Group comparison (Arcoxia® \[Initiation\] vs Arcoxia® \[Renewal\]) for significant past treatments||||0.701
71877054|NCT01572675|143273040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007|||||||Chi-squared|||Group comparison (Celebrex® \[Initiation\] vs Celebrex® \[Renewal\]) for significant past treatments||||0.007
71877055|NCT01572675|143273040|SUPERIORITY_OR_OTHER_LEGACY|||||||0.955|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for significant past treatments||||0.955
71877056|NCT01572675|143273043|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049|||||||Fisher Exact|||Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications||||0.049
71877057|NCT01572675|143273046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.165|||||||Chi-squared|||Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment||||0.165
71877058|NCT01660451|143273061|SUPERIORITY_OR_OTHER_LEGACY||Response rate|45.45||||0.0001|TWO_SIDED|90.0|30.49|61.06||0.0001|Exact binomial test|||Response rate was statistically compared by exact binomial test if higher than 5%.||61.06|30.49|0.0001
71877059|NCT01660451|143273061|SUPERIORITY_OR_OTHER_LEGACY||Response rate|27.08||||0.0001|TWO_SIDED|90.0|16.83|39.57||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.||39.57|16.83|0.0001
71877060|NCT01660451|143273062|SUPERIORITY_OR_OTHER_LEGACY||Response rate|59.15|||<|0.0001|TWO_SIDED|95.0|50.6|67.32||0.001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||67.32|50.60|<0.0001
71877061|NCT01660451|143273063|SUPERIORITY_OR_OTHER_LEGACY||Response rate|46.88||||0.0001|TWO_SIDED|90.0|31.54|62.66||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||62.66|31.54|0.0001
71877062|NCT01660451|143273063|SUPERIORITY_OR_OTHER_LEGACY||Response rate|31.25||||0.0001|TWO_SIDED|90.0|20.35|43.97||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.||43.97|20.35|0.0001
71877063|NCT01660451|143273064|SUPERIORITY_OR_OTHER_LEGACY||Response rate|51.41||||0.0039|TWO_SIDED|95.0|42.88|59.87||0.01|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.||59.87|42.88|0.0039
71877064|NCT01660451|143273075|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|1.0|||||TWO_SIDED|95.0|0.5|2.5||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||2.5|0.5|
71877065|NCT01660451|143273076|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimate|0.5|||||TWO_SIDED|95.0|-0.7|3.2||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.||3.2|-0.7|
71877066|NCT02281357|143273099|SUPERIORITY|The null hypothesis was that the average percentage change in OCS dose on tralokinumab was equal to the average percentage change in OCS dose on placebo.|LS Mean difference|-7.78||||0.271|TWO_SIDED|95.0|-21.7|6.15|||ANCOVA|The analysis of covariance (ANCOVA) model utilised a sandwich estimator for the variance.|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate. No interaction terms were included in the model. All group comparisons from the ANCOVA model were based on Type III sums of squares.|Comparison of percent change from baseline in OCS dose: tralokinumab vs placebo.||6.15|-21.70|0.271
71877067|NCT02281357|143273100|SUPERIORITY||Odds Ratio (OR)|1.33||||0.442|TWO_SIDED|95.0|0.65|2.73|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of OCS dose ≤5.0 mg: tralokinumab vs placebo.||2.73|0.65|0.442
71684950|NCT01134263|142888095|EQUIVALENCE|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was \> -0.301 and the upper limit was \< 0.301.|Difference of Log10 GMT|-0.017|||||TWO_SIDED|95.0|-0.137|0.103||||||Dengue Virus Serotype 4||0.103|-0.137|
71684951|NCT04165135|142888098|OTHER|||||||0.763|||||||Kruskal-Wallis|||Heart zone minutes: Comparison among the age groups was performed by means of a Kruskal-Wallis test.||||0.7630
71684952|NCT04165135|142888098|OTHER|||||||0.0913|||||||Kruskal-Wallis|||Active zone minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0913
71684953|NCT04165135|142888098|OTHER|||||||0.0956|||||||Kruskal-Wallis|||MVPA minutes: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0956
71684954|NCT04165135|142888099|OTHER|||||||0.0649|||||||Kruskal-Wallis|||||||0.0649
71684955|NCT04165135|142888100|OTHER|||||||0.0026|||||||Kruskal-Wallis|||||||0.0026
71684956|NCT04165135|142888101|OTHER|||||||0.9493|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9493
71684957|NCT04165135|142888101|OTHER|||||||0.8305|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8305
71684958|NCT04165135|142888101|OTHER|||||||0.8725|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.8725
71877068|NCT02281357|143273101|SUPERIORITY||Odds Ratio (OR)|1.38||||0.356|TWO_SIDED|95.0|0.7|2.74|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of ≥50% reduction in OCS dose: tralokinumab vs placebo.||2.74|0.70|0.356
71877069|NCT02281357|143273102|SUPERIORITY||Rate Ratio|0.8||||0.186|TWO_SIDED|95.0|0.57|1.12|||Negative binomial||Treatment group, OCS dose at baseline, and number of exacerbations in the previous year are included in the model as covariates.|Comparison of AAER: tralokinumab vs placebo.||1.12|0.57|0.186
71877070|NCT05314712|143273103|OTHER|Linear Mixed Model (repeated measures model) of sleep trouble||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. Under the assumption that the likert scale data was treated as continuous, the data was analyzed using a linear mixed model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final sleep trouble model included the covariates timing of survey, DASS scale, and indicator variable if child played outside.|||
71917784|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-195.3|STANDARD_ERROR_OF_MEAN|207.38||0.354|TWO_SIDED|95.0|-618.8|228.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using Analysis of Covariance (ANCOVA) with baseline fitted as a covariate.||228.3|-618.8|0.354
71917785|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.1|STANDARD_ERROR_OF_MEAN|190.99||0.86|TWO_SIDED|95.0|-424.1|356.0|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||356.0|-424.1|0.860
71917786|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-435.7|STANDARD_ERROR_OF_MEAN|195.94||0.034|TWO_SIDED|95.0|-835.9|-35.6|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||-35.6|-835.9|0.034
71684959|NCT04165135|142888101|OTHER|||||||0.338|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3380
71684960|NCT04165135|142888101|OTHER|||||||0.9706|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9706
71684961|NCT04165135|142888101|OTHER|||||||0.1727|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1727
71684962|NCT04165135|142888101|OTHER|||||||0.0099|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0099
71684963|NCT04165135|142888102|OTHER|||||||0.6151|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.6151
71684964|NCT04165135|142888102|OTHER|||||||0.9332|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.9332
71684965|NCT04165135|142888102|OTHER|||||||0.4726|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4726
71684966|NCT04165135|142888102|OTHER|||||||0.4111|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4111
71684967|NCT04165135|142888102|OTHER|||||||0.0892|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0892
71684968|NCT04165135|142888102|OTHER|||||||0.1642|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1642
71684969|NCT04165135|142888102|OTHER|||||||0.7256|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.7256
71684970|NCT04165135|142888103|OTHER|||||||0.0745|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0745
71684971|NCT04165135|142888103|OTHER|||||||0.2177|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2177
71684972|NCT04165135|142888103|OTHER|||||||0.2121|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2121
71684973|NCT04165135|142888103|OTHER|||||||0.2336|||||||Kruskal-Wallis|||Gym weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2336
71917787|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-334.7|STANDARD_ERROR_OF_MEAN|201.74||0.107|TWO_SIDED|95.0|-746.7|77.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||77.3|-746.7|0.107
71684974|NCT04165135|142888103|OTHER|||||||0.419|||||||Kruskal-Wallis|||Exercises at intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.4190
71684975|NCT04165135|142888103|OTHER|||||||0.0252|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0252
71684976|NCT04165135|142888103|OTHER|||||||0.2143|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2143
71684977|NCT04165135|142888104|OTHER|||||||0.0085|||||||Kruskal-Wallis|||Running: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0085
71684978|NCT04165135|142888104|OTHER|||||||0.1098|||||||Kruskal-Wallis|||Swimming: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1098
71684979|NCT04165135|142888104|OTHER|||||||0.2703|||||||Kruskal-Wallis|||Tapis Roulant: Comparison among age groups was performed using Kruskal-Wallis test.||||0.2703
71684980|NCT04165135|142888104|OTHER|||||||0.3366|||||||Kruskal-Wallis|||Gym Weights: Comparison among age groups was performed using Kruskal-Wallis test.||||0.3366
71684981|NCT04165135|142888104|OTHER|||||||0.0992|||||||Kruskal-Wallis|||Exercises at Intervals: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0992
71684982|NCT04165135|142888104|OTHER|||||||0.1194|||||||Kruskal-Wallis|||General: Comparison among age groups was performed using Kruskal-Wallis test.||||0.1194
71684983|NCT04165135|142888104|OTHER|||||||0.0549|||||||Kruskal-Wallis|||Walk: Comparison among age groups was performed using Kruskal-Wallis test.||||0.0549
71684984|NCT04165135|142888105|OTHER|||||||0.0088|||||||Chi-squared|||Comparison among age groups was performed using Chi-squared test.||||0.0088
71684985|NCT03763058|142888162|SUPERIORITY||Mean Difference (Final Values)|-2.8|STANDARD_DEVIATION|4.19||0.012|TWO_SIDED|95.0|||||Sign test|||||||0.012
71684986|NCT03763058|142888163|SUPERIORITY||Mean Difference (Final Values)|-5.45|STANDARD_DEVIATION|15.52||0.002|TWO_SIDED|95.0|||||Sign test|||||||0.002
71882618|NCT02706873|143284636|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|29.8|||<|0.001|TWO_SIDED|95.0|22.8|36.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||36.8|22.8|<0.001
71684987|NCT03763058|142888164|SUPERIORITY||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|2.71||0.045|TWO_SIDED|95.0|||||Sign test|||||||0.045
71684988|NCT03763058|142888165|SUPERIORITY||Mean Difference (Final Values)|-3.65|STANDARD_DEVIATION|4.59|<|0.001|TWO_SIDED|95.0|||||Sign test|||||||<0.001
71684989|NCT03763058|142888166|SUPERIORITY||Mean Difference (Final Values)|-4.15|STANDARD_DEVIATION|5.1|<|0.001|TWO_SIDED|95.0|||||Sign test|||Total HAD score||||<0.001
71684990|NCT00497055|142888175|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.41||95.0|0.66|1.16|||Generalized estimating equation|||||1.16|.66|.41
71684991|NCT00497055|142888176|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.31
71684992|NCT00497055|142888177|SUPERIORITY_OR_OTHER||||||>=|0.99|||||||Fisher Exact|||||||>=0.99
71684993|NCT01625689|142888250|SUPERIORITY_OR_OTHER||||||>=|0.498|TWO_SIDED|||||No comparison between the LAIV and placebo groups by type of solicited reaction had a p-value below 0.498.|Fisher Exact|||||||>=0.498
71684994|NCT00477607|142888258|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0||||0.89|TWO_SIDED|95.0|0.4|11.4|||Fisher Exact|No adjustments. Right one-sided p-value.||H0: pr(Hearing loss arm 1) = pr(Hearing loss arm 2)||11.4|0.4|0.89
71684995|NCT00477607|142888259|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.195|STANDARD_ERROR_OF_MEAN|0.3999||0.63|TWO_SIDED|95.0|-1.03|0.64|||t-test, 2 sided|||H0: mean (MDA arm 1) = mean (MDA Arm 2)||0.64|-1.03|0.63
71684996|NCT00477607|142888260|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.2|STANDARD_ERROR_OF_MEAN|32.7||0.15|TWO_SIDED|95.0|-18.1|114.6|||t-test, 2 sided|||H0: mean(max dose arm 1) = mean(max dose arm 2)||114.6|-18.1|0.15
71684997|NCT00564278|142888261|SUPERIORITY_OR_OTHER_LEGACY||GEE model Beta|17.46||||0.26|TWO_SIDED|95.0|-16.61|51.53||All analyses presented are at 9 months.|t-test, 2 sided|t(193) = -1.14, p=.26||"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.~We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found."||51.53|-16.61|0.26
71684998|NCT00564278|142888262|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.28|||||TWO_SIDED|95.0|-1.57|1.01||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.|||1.01|-1.57|
71882619|NCT02706873|143284636|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|31.5|||<|0.001|TWO_SIDED|95.0|24.5|38.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||38.5|24.5|<0.001
71877071|NCT05314712|143273103|OTHER|Mixed effects linear regression model of hours slept||||||||||||There was no hypothesis test. All participants received the 7-week intervention - there was no comparison group. A variable selection approach (AIC) was used for including the final variables in the model.||||Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. The data was analyzed using a mixed effects linear regression model. Variables in final model were included after variable selection (details below).|Using an exhaustive search of all models (dredge) that could be formed from predictor variables partner sleep rating, perceived stress, DASS scale, 8-item diet scale, amount of screen time, amount of time between bed time and wake time, amount of time to fall asleep, hours of sleep, sleep rating score, indicator variable if the child played outside, bed time, and wake time, adult height in inches, adult BMI, adult's highest education attained, the number of children in the household, grade of the child, child height in inches, child BMI, age of the child, and gender of the child, requiring the the timing of the survey be in the model, and accounting for repeated measurements over time, using AIC as the selection criterion we looked for the model with the smallest AIC value. The final model for hours slept included the covariates number of children in the household, indicator variable if child played outside, and baseline hours slept.|||
71877072|NCT01499953|143273104|NON_INFERIORITY|The hypotheses for non-inferiority test using ∆=4.5% for the difference between incidence rates were H0: πrivaroxaban-πfondaparinux ≥ 4.5%, H1: πrivaroxaban-πfondaparinux \< 4.5% where πfondaparinux and πrivaroxaban were the incidence rates of CIAC confirmed VTE complications up to Day 45 in the treatment groups. Rejection of the null hypothesis would have concluded that rivaroxaban was not inferior to fondaparinux. To calculate the p-value, an asymptotic test for non-inferiority was used.||||||0.0252|||||||asymptotic test for non-inferiority|||||||0.0252
71877073|NCT00823303|143273126|NON_INFERIORITY_OR_EQUIVALENCE|On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.||||||0.36|||||||Fisher Exact|||||||0.36
71877074|NCT00395863|143273247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test|||||||< 0.0001
71877075|NCT00395863|143273247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
71877076|NCT00395863|143273247|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||< 0.0001
71877077|NCT00395863|143273248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||Reader 1|wilcoxon signed-rank test|||||||0.0001
71877078|NCT00395863|143273248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||Reader 2|wilcoxon signed-rank test|||||||0.001
71877079|NCT00395863|143273248|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||Reader 3|wilcoxon signed-rank test|||||||0.0002
71877080|NCT00395863|143273249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Reader 1|wilcoxon signed-rank test|||||||<0.0001
71877081|NCT00395863|143273249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test|||||||<0.0001
71877082|NCT00395863|143273249|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test|||||||<0.0001
71877083|NCT00395863|143273250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_DEVIATION|0.22|<|0.0001||95.0|0.14|0.3||Mean difference of MultiHance minus Magnevist for change from baseline|t-test, 2 sided|||||0.30|0.14|<0.0001
71877084|NCT00395863|143273251|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|0.2|<|0.0001||95.0|0.22|0.38||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.38|0.22|<0.0001
71877085|NCT00395863|143273252|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.19|<|0.0001||95.0|0.18|0.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||0.33|0.18|<0.0001
71877086|NCT00395863|143273253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|40.99|STANDARD_DEVIATION|59.78||0.0062||95.0|20.72|61.26||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||61.26|20.72|0.0062
71877087|NCT00395863|143273254|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|30.95|STANDARD_DEVIATION|48.64||0.0027||95.0|16.57|45.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||45.33|16.57|0.0027
71877088|NCT00395863|143273255|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|25.04|STANDARD_DEVIATION|37.37||0.02||95.0|12.41|37.67||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided|||||37.67|12.41|0.02
71877089|NCT00395863|143273256|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|32.77|STANDARD_DEVIATION|48.51||0.0019||95.0|14.28|51.25||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||51.25|14.28|0.0019
71877090|NCT00395863|143273257|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.61|STANDARD_DEVIATION|43.16||0.0008||95.0|16.75|50.47||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||50.47|16.75|0.0008
71877091|NCT00395863|143273258|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|33.72|STANDARD_DEVIATION|48.5||0.0026||95.0|14.63|52.81||Mean difference of Multihance minus Magnevist|t-test, 2 sided|||||52.81|14.63|0.0026
71877092|NCT02592551|143273261|OTHER||Median Difference (Final Values)|8.6||||0.109|TWO_SIDED||||||Wilcoxon signed rank test|||Compare in ratios of intratumoral cytotoxic T cells to regulatory T cells (CD8/Treg) between pre and post of MEDI4736+Tremelimumab||||0.109
71877093|NCT02592551|143273262|OTHER|Compare the tissue biomarker for the immune response of ICOS+ CD4 T cells to before and after MEDI-4736 and Tremelimumab||||||1|||||||Wilcoxon signed rank test|||||||1
71877094|NCT02592551|143273263|OTHER|||||||0.461|||||||Wilcoxon signed rank test|||Compare tumor expression programmed death-ligand 1 (PD-L1) before and after treatment with combination MEDI-4736 and Tremelimumab||||0.461
71877095|NCT02592551|143273264|OTHER|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg (ratio of CD8/treg) after MEDI-4736 and Tremelimumab, and after MEDI4736 alone||||0.954
71877096|NCT02592551|143273265|OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||Compare tissue biomarker immune response of CD8 and Treg(ratio of CD8/Treg) after MEDI-4736 and Tremelimumab, and at day 1 of untread control group||||0.799
71877097|NCT02592551|143273268|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone||||0.418
71917788|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-278.0|STANDARD_ERROR_OF_MEAN|200.89||0.177|TWO_SIDED|95.0|-688.3|132.2|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||132.2|-688.3|0.177
71917789|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|51.1|STANDARD_ERROR_OF_MEAN|315.91||0.873|TWO_SIDED|95.0|-594.1|696.3|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||696.3|-594.1|0.873
71917790|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|75.2|STANDARD_ERROR_OF_MEAN|303.08||0.806|TWO_SIDED|95.0|-543.8|694.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||694.1|-543.8|0.806
71917791|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-262.8|STANDARD_ERROR_OF_MEAN|301.1||0.39|TWO_SIDED|95.0|-877.8|352.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||352.1|-877.8|0.390
71917792|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-329.4|STANDARD_ERROR_OF_MEAN|302.97||0.286|TWO_SIDED|95.0|-948.1|289.4|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||289.4|-948.1|0.286
71917793|NCT00853112|143357729|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.7|STANDARD_ERROR_OF_MEAN|314.15||0.843|TWO_SIDED|95.0|-704.3|578.9|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.||578.9|-704.3|0.843
71917794|NCT00853112|143357730|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|322.8||0.999|TWO_SIDED|95.0|-659.7|658.8|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||658.8|-659.7|0.999
71917795|NCT00853112|143357730|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|72.2|STANDARD_ERROR_OF_MEAN|309.69||0.817|TWO_SIDED|95.0|-560.2|704.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||704.7|-560.2|0.817
71917796|NCT00853112|143357730|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-82.6|STANDARD_ERROR_OF_MEAN|307.67||0.79|TWO_SIDED|95.0|-711.0|545.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||545.7|-711.0|0.790
71917797|NCT00853112|143357730|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-325.6|STANDARD_ERROR_OF_MEAN|309.58||0.301|TWO_SIDED|95.0|-957.8|306.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||306.7|-957.8|0.301
71917798|NCT00853112|143357730|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.2|STANDARD_ERROR_OF_MEAN|321.0||0.85|TWO_SIDED|95.0|-716.8|594.4|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.||594.4|-716.8|0.850
71917799|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-269.32|STANDARD_ERROR_OF_MEAN|252.93||0.295|TWO_SIDED|95.0|-785.39|246.76|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||246.76|-785.39|0.295
71917800|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-97.65|STANDARD_ERROR_OF_MEAN|234.55||0.68|TWO_SIDED|95.0|-577.02|381.72|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||381.72|-577.02|0.680
71917801|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-376.61|STANDARD_ERROR_OF_MEAN|241.06||0.129|TWO_SIDED|95.0|-869.53|116.31|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||116.31|-869.53|0.129
71877098|NCT02592551|143273269|OTHER|||||||0.932|||||||Wilcoxon (Mann-Whitney)|||Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and before and at day 1 of untreated||||0.932
71877099|NCT02137512|143273297|SUPERIORITY|No adjustments were made for multiple comparisons.|||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877100|NCT02137512|143273297|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71917802|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-342.29|STANDARD_ERROR_OF_MEAN|247.07||0.176|TWO_SIDED|95.0|-846.9|162.32|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||162.32|-846.90|0.176
71917803|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-316.86|STANDARD_ERROR_OF_MEAN|261.58||0.235|TWO_SIDED|95.0|-850.9|217.17|||Longitudinal analysis|||Hour 1: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||217.17|-850.90|0.235
71917804|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-198.06|STANDARD_ERROR_OF_MEAN|247.62||0.43|TWO_SIDED|95.0|-705.04|308.91|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||308.91|-705.04|0.430
71917805|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.9|STANDARD_ERROR_OF_MEAN|229.23||0.87|TWO_SIDED|95.0|-432.23|508.04|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||508.04|-432.23|0.870
71917806|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-114.06|STANDARD_ERROR_OF_MEAN|244.95||0.645|TWO_SIDED|95.0|-614.57|386.45|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||386.45|-614.57|0.645
71877101|NCT02137512|143273297|SUPERIORITY|||||||0.31||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.31
71877102|NCT02137512|143273298|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
71877103|NCT02137512|143273298|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877104|NCT02137512|143273298|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877105|NCT02137512|143273299|SUPERIORITY|||||||0.1||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.10
71684999|NCT00564278|142888263|SUPERIORITY_OR_OTHER_LEGACY||Work - Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.5|0.95||See under Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.|||0.95|-0.50|
71685000|NCT00564278|142888263|SUPERIORITY_OR_OTHER_LEGACY||Social-Mixed Model Beta for MADT vs SADT|0.22|||||TWO_SIDED|95.0|-0.49|0.92||See under Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.|||0.92|-0.49|
71685001|NCT00564278|142888263|SUPERIORITY_OR_OTHER_LEGACY||Family-Mixed Model Beta for MADT vs SADT|0.55|||||TWO_SIDED|95.0|-0.08|1.18||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.|||1.18|-0.08|
71685002|NCT00564278|142888264|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|0.02|||||TWO_SIDED|95.0|-3.61|3.64||See Method of Estimation, below|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.|||3.64|-3.61|
71685003|NCT00564278|142888265|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|-0.04|||||TWO_SIDED|95.0|-0.74|0.66||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.|||0.66|-0.74|
71685004|NCT00564278|142888266|SUPERIORITY_OR_OTHER_LEGACY||Mixed Model Beta for MADT vs SADT|9.14|||||TWO_SIDED|95.0|2.71|15.57||See Method of Estimation below.|||A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.|||15.57|2.71|
71685005|NCT02368886|142888273|SUPERIORITY||Risk Difference (RD)|0.17||||0.0434|TWO_SIDED|95.0|0.0|0.34||1-sided|Fisher Exact|||||0.34|0.00|0.0434
71685006|NCT02368886|142888274|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1241|TWO_SIDED|95.0|0.47|1.1|||Log Rank|||||1.10|0.47|0.1241
71685007|NCT02368886|142888275|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3797|TWO_SIDED|95.0|0.57|1.24|||Log Rank|||||1.24|0.57|0.3797
71877106|NCT02137512|143273299|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877107|NCT02137512|143273299|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877108|NCT02137512|143273300|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877109|NCT02137512|143273300|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71685008|NCT02368886|142888276|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.4614|TWO_SIDED|95.0|0.55|1.31|||Log Rank|||||1.31|0.55|0.4614
71685009|NCT02368886|142888281|SUPERIORITY|||||||0.7319|||||||Kruskal-Wallis|||||||0.7319
71685010|NCT04997265|142888316|OTHER|Given the small sample size, simple descriptive were used. Between-group differences were performed using a Fisher exact test.|||||<|0.05|||||||Fisher Exact|||||||<0.05
71685011|NCT04847232|142888330|OTHER|Test of HR = 1|Hazard Ratio (HR)|0.98||||0.867|TWO_SIDED|95.0|0.76|1.26|||Regression, Cox||SZC relative to Placebo|||1.26|0.76|0.867
71685012|NCT04847232|142888331|OTHER|Test of OR = 1|Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.64|4.26|||Regression, Logistic||SZC relative to Placebo|||4.26|2.64|<.0001
71685013|NCT04847232|142888332|OTHER|Test of HR = 1|Hazard Ratio (HR)|1.12||||0.51|TWO_SIDED|95.0|0.8|1.56|||Regression, Cox||SZC relative to Placebo|||1.56|0.80|0.510
71685014|NCT02290925|142888344|OTHER|general linear model (GLM) with repeated measures|Mean Difference (Net)|0.25|||||TWO_SIDED||||||||Box's M tests was used. Mauchly's test was used to verify that the error covariance matrix of the orthonormalized-transformed dependent variables is proportional to an identity matrix.||"We used intention to treat analysis. Since the missing data were more than 5%, we examined the dataset to determine whether it shows missing completely at random (MCAR) not missing at random (NMAR) or data missing at random (MAR). A sensitivity analysis was done to determine whether multiple imputations are required. It included complete case analysis, best-worst case and worst best case scenario with group mean±1SD."|||
71877110|NCT02137512|143273300|SUPERIORITY|||||||0.91||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.91
71685015|NCT01716520|142888348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121|||<|0.001|TWO_SIDED|95.0|0.085|0.157||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 milliliters (mL) at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.157|0.085|<0.001
71685016|NCT01716520|142888348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|||<|0.001|TWO_SIDED|95.0|0.1|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.171|0.100|<0.001
71877111|NCT02137512|143273301|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877112|NCT02137512|143273301|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877113|NCT02137512|143273301|SUPERIORITY|||||||0.2||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.20
71877114|NCT02137512|143273302|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
71877115|NCT02137512|143273302|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877116|NCT02137512|143273302|SUPERIORITY|||||||0.49||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.49
71917807|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-299.6|STANDARD_ERROR_OF_MEAN|241.63||0.225|TWO_SIDED|95.0|-794.81|195.61|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||195.61|-794.81|0.225
71917808|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-332.25|STANDARD_ERROR_OF_MEAN|255.93||0.205|TWO_SIDED|95.0|-856.55|192.05|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||192.05|-856.55|0.205
71917809|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.72|STANDARD_ERROR_OF_MEAN|263.63||0.745|TWO_SIDED|95.0|-625.87|452.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||452.42|-625.87|0.745
71917810|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.0|STANDARD_ERROR_OF_MEAN|245.25||0.942|TWO_SIDED|95.0|-484.46|520.47|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||520.47|-484.46|0.942
71917811|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-265.94|STANDARD_ERROR_OF_MEAN|259.53||0.314|TWO_SIDED|95.0|-796.15|264.28|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||264.28|-796.15|0.314
71917812|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-275.35|STANDARD_ERROR_OF_MEAN|258.01||0.295|TWO_SIDED|95.0|-803.57|252.88|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||252.88|-803.57|0.295
71917813|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-326.55|STANDARD_ERROR_OF_MEAN|272.96||0.241|TWO_SIDED|95.0|-885.12|232.02|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||232.02|-885.12|0.241
71917814|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-145.71|STANDARD_ERROR_OF_MEAN|218.5||0.51|TWO_SIDED|95.0|-592.24|300.83|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||300.83|-592.24|0.510
71917815|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|77.96|STANDARD_ERROR_OF_MEAN|199.85||0.699|TWO_SIDED|95.0|-330.7|486.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||486.63|-330.70|0.699
71917816|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-341.91|STANDARD_ERROR_OF_MEAN|204.65||0.106|TWO_SIDED|95.0|-760.45|76.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||76.64|-760.45|0.106
71917817|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-289.41|STANDARD_ERROR_OF_MEAN|211.69||0.182|TWO_SIDED|95.0|-722.17|143.35|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||143.35|-722.17|0.182
71917818|NCT00853112|143357731|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-256.6|STANDARD_ERROR_OF_MEAN|224.88||0.263|TWO_SIDED|95.0|-716.26|203.06|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||203.06|-716.26|0.263
71917819|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-328.1|STANDARD_ERROR_OF_MEAN|385.78||0.401|TWO_SIDED|95.0|-1114.11|457.92|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||457.92|-1114.11|0.401
71917820|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-164.96|STANDARD_ERROR_OF_MEAN|370.54||0.659|TWO_SIDED|95.0|-920.05|590.12|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.12|-920.05|0.659
71917821|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-287.08|STANDARD_ERROR_OF_MEAN|372.6||0.447|TWO_SIDED|95.0|-1047.59|473.42|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||473.42|-1047.59|0.447
71917822|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-457.16|STANDARD_ERROR_OF_MEAN|374.26||0.231|TWO_SIDED|95.0|-1220.86|306.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||306.53|-1220.86|0.231
71917823|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-75.24|STANDARD_ERROR_OF_MEAN|384.2||0.846|TWO_SIDED|95.0|-858.19|707.71|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||707.71|-858.19|0.846
71917824|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-115.64|STANDARD_ERROR_OF_MEAN|357.2||0.748|TWO_SIDED|95.0|-844.24|612.96|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||612.96|-844.24|0.748
71917825|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.87|STANDARD_ERROR_OF_MEAN|342.91||0.993|TWO_SIDED|95.0|-702.41|696.67|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.67|-702.41|0.993
71917826|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|174.2|STANDARD_ERROR_OF_MEAN|342.93||0.615|TWO_SIDED|95.0|-526.41|874.81|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||874.81|-526.41|0.615
71917827|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-494.91|STANDARD_ERROR_OF_MEAN|344.72||0.161|TWO_SIDED|95.0|-1199.04|209.21|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||209.21|-1199.04|0.161
71877117|NCT02137512|143273303|SUPERIORITY|||||||0.009||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.009
71877118|NCT02137512|143273303|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
71877119|NCT02137512|143273303|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
71877120|NCT02137512|143273304|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
71877121|NCT02137512|143273304|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
71877122|NCT02137512|143273304|SUPERIORITY|||||||0.18||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.18
71877123|NCT02137512|143273305|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
71877124|NCT02137512|143273305|SUPERIORITY|||||||0.54||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.54
71877125|NCT02137512|143273305|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
71877126|NCT02137512|143273306|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
71877127|NCT02137512|143273306|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877128|NCT02137512|143273306|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
71877129|NCT02137512|143273307|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877130|NCT02137512|143273307|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877131|NCT02137512|143273307|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
71917828|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-134.48|STANDARD_ERROR_OF_MEAN|355.5||0.708|TWO_SIDED|95.0|-859.74|590.77|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||590.77|-859.74|0.708
71917829|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|47.61|STANDARD_ERROR_OF_MEAN|365.43||0.897|TWO_SIDED|95.0|-697.56|792.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||792.79|-697.56|0.897
71877132|NCT02137512|143273308|SUPERIORITY|||||||0.13||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.13
71877133|NCT02137512|143273308|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877134|NCT02137512|143273308|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877135|NCT02137512|143273309|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877136|NCT02137512|143273309|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877137|NCT02137512|143273309|SUPERIORITY|||||||0.41||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.41
71877138|NCT02137512|143273310|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877139|NCT02137512|143273310|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877140|NCT02137512|143273310|SUPERIORITY|||||||0.12||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.12
71877141|NCT02137512|143273311|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
71877142|NCT02137512|143273311|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877143|NCT02137512|143273311|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
71877144|NCT02137512|143273312|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877145|NCT02137512|143273312|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
71877146|NCT02137512|143273312|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
71877147|NCT02137512|143273313|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877148|NCT02137512|143273313|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877149|NCT02137512|143273313|SUPERIORITY|||||||0.11||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.11
71877150|NCT02137512|143273314|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
71877151|NCT02137512|143273314|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
71877152|NCT02137512|143273314|SUPERIORITY|||||||0.61||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.61
71877153|NCT02137512|143273315|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877154|NCT02137512|143273315|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877155|NCT02137512|143273315|SUPERIORITY|||||||0.29||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.29
71877156|NCT02137512|143273316|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877157|NCT02137512|143273316|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
71877158|NCT02137512|143273316|SUPERIORITY||||||>|0.99||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||>0.99
71877159|NCT02137512|143273317|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
71877160|NCT02137512|143273317|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877161|NCT02137512|143273317|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
71877162|NCT02137512|143273318|SUPERIORITY|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.002
71685017|NCT01716520|142888348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|||<|0.001|TWO_SIDED|95.0|0.11|0.174||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.174|0.110|<0.001
71685018|NCT01716520|142888348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.067|0.13||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of \>=12% and 200 mL at \>=1 time point over 0-6 hours post-dose in FEV1 on Day 1.|||0.130|0.067|<0.001
71685019|NCT01716520|142888348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052||||0.047|TWO_SIDED|95.0|0.001|0.104||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.104|0.001|0.047
71877163|NCT02137512|143273318|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877164|NCT02137512|143273318|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877165|NCT02137512|143273319|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877166|NCT02137512|143273319|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877167|NCT02137512|143273319|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
71877168|NCT02137512|143273320|SUPERIORITY|||||||0.04||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.04
71877169|NCT02137512|143273320|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877170|NCT02137512|143273320|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877171|NCT02137512|143273321|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
71877172|NCT02137512|143273321|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877173|NCT02137512|143273321|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877174|NCT02137512|143273322|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 1 sided|||||||<0.001
71877175|NCT02137512|143273322|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877176|NCT02137512|143273322|SUPERIORITY|||||||0.53||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.53
71877177|NCT02137512|143273323|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
71877178|NCT02137512|143273323|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877179|NCT02137512|143273323|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877180|NCT02137512|143273324|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877181|NCT02137512|143273324|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877182|NCT02137512|143273324|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877183|NCT02137512|143273325|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877184|NCT02137512|143273325|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877185|NCT02137512|143273325|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
71877186|NCT02137512|143273326|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
71877187|NCT02137512|143273326|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877188|NCT02137512|143273326|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877189|NCT02137512|143273327|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877190|NCT02137512|143273327|SUPERIORITY|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.001
71877191|NCT02137512|143273327|SUPERIORITY|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.26
71877192|NCT02137512|143273328|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877193|NCT02137512|143273328|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877194|NCT02137512|143273328|SUPERIORITY|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.05
71877195|NCT02137512|143273329|SUPERIORITY|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.03
71877196|NCT02137512|143273329|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
71877197|NCT02137512|143273329|SUPERIORITY|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.52
71685020|NCT01716520|142888348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073||||0.006|TWO_SIDED|95.0|0.021|0.124||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of \>=12% and 200 mL at any assessment(s).|||0.124|0.021|0.006
71685021|NCT05460078|142888360|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.16|1.68|||Mixed Models Analysis|||||1.68|1.16|<0.001
71685022|NCT05460078|142888361|SUPERIORITY||Odds Ratio (OR)|1.39|||<|0.001|TWO_SIDED|95.0|1.18|1.65|||Mixed Models Analysis|||||1.65|1.18|<0.001
71685023|NCT05460078|142888362|SUPERIORITY||Odds Ratio (OR)|1.96|||<|0.001|TWO_SIDED|95.0|1.54|2.48|||Mixed Models Analysis|||||2.48|1.54|<0.001
71877198|NCT02137512|143273330|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
71877199|NCT02137512|143273330|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877200|NCT02137512|143273330|SUPERIORITY|||||||0.71||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.71
71877201|NCT02137512|143273331|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877202|NCT02137512|143273331|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877203|NCT02137512|143273331|SUPERIORITY|||||||0.39||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.39
71877204|NCT02137512|143273332|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877205|NCT02137512|143273332|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877206|NCT02137512|143273332|SUPERIORITY|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.06
71877207|NCT02137512|143273333|SUPERIORITY|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.02
71877208|NCT02137512|143273333|SUPERIORITY|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.003
71877209|NCT02137512|143273333|SUPERIORITY|||||||0.86||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.86
71877210|NCT02137512|143273334|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877211|NCT02137512|143273334|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877212|NCT02137512|143273334|SUPERIORITY|||||||0.74||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.74
71877213|NCT02137512|143273335|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877214|NCT02137512|143273335|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71917830|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|98.42|STANDARD_ERROR_OF_MEAN|350.87||0.781|TWO_SIDED|95.0|-617.15|813.99|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||813.99|-617.15|0.781
71877215|NCT02137512|143273335|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
71877216|NCT02137512|143273336|SUPERIORITY|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.07
71877217|NCT02137512|143273336|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
71877218|NCT02137512|143273336|SUPERIORITY|||||||0.68||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.68
71877219|NCT02137512|143273337|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
71877220|NCT02137512|143273337|SUPERIORITY|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.005
71877221|NCT02137512|143273337|SUPERIORITY|||||||0.62||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.62
71877222|NCT02137512|143273338|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877223|NCT02137512|143273338|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
71877224|NCT02137512|143273338|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
71877225|NCT02137512|143273339|SUPERIORITY|||||||0.67||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.67
71877226|NCT02137512|143273339|SUPERIORITY|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.09
71877227|NCT02137512|143273339|SUPERIORITY|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.22
71877228|NCT02137512|143273340|SUPERIORITY|||||||0.25||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.25
71877229|NCT02137512|143273341|SUPERIORITY|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.23
71877230|NCT02137512|143273342|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877231|NCT02137512|143273343|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877232|NCT02137512|143273344|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877233|NCT02137512|143273345|SUPERIORITY||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||<0.001
71877234|NCT02137512|143273346|SUPERIORITY|||||||0.01||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.01
71877235|NCT02137512|143273347|SUPERIORITY|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.006
71877236|NCT02137512|143273348|SUPERIORITY|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided|||||||0.14
71877237|NCT01086410|143273374|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.99|||||TWO_SIDED|95.0|0.87|1.12|||||Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.12|0.87|
71685024|NCT05460078|142888363|SUPERIORITY||Odds Ratio (OR)|1.4|||<|0.001|TWO_SIDED|95.0|1.17|1.66|||Mixed Models Analysis|||||1.66|1.17|<0.001
71877238|NCT01086410|143273374|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.97|||||TWO_SIDED|95.0|0.86|1.1|||||Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||1.10|0.86|
71877239|NCT01086410|143273374|SUPERIORITY_OR_OTHER||Ratio of least square gometric mean|0.34|||||TWO_SIDED|95.0|0.28|0.41|||||Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.|||0.41|0.28|
71877240|NCT02953639|143273396|SUPERIORITY||Treatment Difference|-0.36||||0.73|TWO_SIDED|90.0|-2.11|1.38|||Mixed Models Analysis|||Week 12 Day 84||1.38|-2.11|0.730
71917831|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-28.31|STANDARD_ERROR_OF_MEAN|355.47||0.937|TWO_SIDED|95.0|-753.46|696.83|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||696.83|-753.46|0.937
71917832|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-369.57|STANDARD_ERROR_OF_MEAN|353.25||0.304|TWO_SIDED|95.0|-1090.86|351.72|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||351.72|-1090.86|0.304
71917833|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-185.64|STANDARD_ERROR_OF_MEAN|363.77||0.613|TWO_SIDED|95.0|-927.54|556.27|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||556.27|-927.54|0.613
71917834|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|265.51|STANDARD_ERROR_OF_MEAN|324.88||0.42|TWO_SIDED|95.0|-397.45|928.48|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||928.48|-397.45|0.420
71917835|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|240.17|STANDARD_ERROR_OF_MEAN|311.63||0.447|TWO_SIDED|95.0|-395.81|876.14|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||876.14|-395.81|0.447
71917836|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-176.74|STANDARD_ERROR_OF_MEAN|309.11||0.572|TWO_SIDED|95.0|-808.1|454.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||454.63|-808.10|0.572
71917837|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.96|STANDARD_ERROR_OF_MEAN|311.11||0.929|TWO_SIDED|95.0|-663.31|607.38|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||607.38|-663.31|0.929
71917838|NCT00853112|143357732|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|29.58|STANDARD_ERROR_OF_MEAN|323.01||0.928|TWO_SIDED|95.0|-629.62|688.79|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||688.79|-629.62|0.928
71917839|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.29||0.412|TWO_SIDED|95.0|-0.35|0.83|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.83|-0.35|0.412
71917840|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.999|TWO_SIDED|95.0|-0.58|0.58|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.58|-0.58|0.999
71917841|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.28||0.535|TWO_SIDED|95.0|-0.39|0.74|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.39|0.535
71917842|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.44|STANDARD_ERROR_OF_MEAN|0.28||0.128|TWO_SIDED|95.0|-0.13|1.01|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.01|-0.13|0.128
71917843|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.29||0.823|TWO_SIDED|95.0|-0.67|0.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.53|-0.67|0.823
71917844|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.29|STANDARD_ERROR_OF_MEAN|0.34||0.396|TWO_SIDED|95.0|-0.4|0.99|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.99|-0.40|0.396
71917845|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|0.33||0.899|TWO_SIDED|95.0|-0.63|0.72|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.72|-0.63|0.899
71917846|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.7|0.64|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.70|0.928
71917847|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.33||0.203|TWO_SIDED|95.0|-0.25|1.11|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.11|-0.25|0.203
71917848|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.34||0.772|TWO_SIDED|95.0|-0.6|0.8|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.60|0.772
71917849|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|0.29||0.771|TWO_SIDED|95.0|-0.52|0.69|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.69|-0.52|0.771
71917850|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.572|TWO_SIDED|95.0|-0.75|0.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.75|0.572
71877241|NCT02953639|143273396|SUPERIORITY||Treatment Difference|0.28||||0.793|TWO_SIDED|90.0|-1.47|2.02|||Mixed Models Analysis|||Week 24 Day 168||2.02|-1.47|0.793
71877242|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.91||||0.556|TWO_SIDED|90.0|-3.46|1.64|||Mixed Models Analysis|||Week 12 Day 84 (Attention/Vigilance)||1.64|-3.46|0.556
71877243|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.27||||0.848|TWO_SIDED|90.0|-2.59|2.05|||Mixed Models Analysis|||Week 24 Day 168 (Attention/Vigilance)||2.05|-2.59|0.848
71877244|NCT02953639|143273397|SUPERIORITY||Treatment Difference|0.04||||0.973|TWO_SIDED|90.0|-2.08|2.16|||Mixed Models Analysis|||Week 12 Day 84 (Reasoning and Problem Solving)||2.16|-2.08|0.973
71877245|NCT02953639|143273397|SUPERIORITY||Treatment Difference|0.57||||0.651|TWO_SIDED|90.0|-1.53|2.67|||Mixed Models Analysis|||Week 24 Day 168 (Reasoning and Problem Solving)||2.67|-1.53|0.651
71877246|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-1.44||||0.35|TWO_SIDED|90.0|-3.89|1.08|||Mixed Models Analysis|||Week 12 Day 84 (Social Cognition)||1.08|-3.89|0.350
71877247|NCT02953639|143273397|SUPERIORITY||Treatment Difference|2.18||||0.121|TWO_SIDED|90.0|-0.14|4.5|||Mixed Models Analysis|||Week 24 Day 168 (Social Cognition)||4.50|-0.14|0.121
71877248|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.13||||0.911|TWO_SIDED|90.0|-2.1|1.83|||Mixed Models Analysis|||Week 12 Day 84 (Speed of Processing)||1.83|-2.10|0.911
71877249|NCT02953639|143273397|SUPERIORITY||Treatment Difference|0.02||||0.987|TWO_SIDED|90.0|-1.99|2.03|||Mixed Models Analysis|||Week 24 Day 168 (Speed of Processing)||2.03|-1.99|0.987
71877250|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.34||||0.803|TWO_SIDED|90.0|-2.62|1.93|||Mixed Models Analysis|||Week 12 Day 84 (Verbal Learning)||1.93|-2.62|0.803
71877251|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.94||||0.502|TWO_SIDED|90.0|-3.26|1.38|||Mixed Models Analysis|||Week 24 Day 168 (Verbal Learning)||1.38|-3.26|0.502
71877252|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.11||||0.945|TWO_SIDED|90.0|-2.74|2.52|||Mixed Models Analysis|||Week 12 Day 84 (Visual Learning)||2.52|-2.74|0.945
71877253|NCT02953639|143273397|SUPERIORITY||Treatment Difference|1.11||||0.488|TWO_SIDED|90.0|-1.54|3.76|||Mixed Models Analysis|||Week 24 Day 168 (Visual Learning)||3.76|-1.54|0.488
71877254|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-1.37||||0.262|TWO_SIDED|90.0|-3.38|0.64|||Mixed Models Analysis|||Week 12 Day 84 (Working Memory)||0.64|-3.38|0.262
71877255|NCT02953639|143273397|SUPERIORITY||Treatment Difference|-0.89||||0.489|TWO_SIDED|90.0|-3.01|1.23|||Mixed Models Analysis|||Week 24 Day 168 (Working Memory)||1.23|-3.01|0.489
71877256|NCT02953639|143273398|SUPERIORITY||Treatment Difference|-1.63||||0.211|TWO_SIDED|90.0|-3.78|0.52|||Mixed Models Analysis|||Week 12 Day 84 (VPA I total raw score)||0.52|-3.78|0.211
71877257|NCT02953639|143273398|SUPERIORITY||Treatment Difference|0.35||||0.787|TWO_SIDED|90.0|-1.81|2.52|||Mixed Models Analysis|||Week 24 Day 168 (VPA I total raw score)||2.52|-1.81|0.787
71877258|NCT02953639|143273398|SUPERIORITY||Treatment Difference|0.28||||0.477|TWO_SIDED|90.0|-0.37|0.94|||Mixed Models Analysis|||Week 12 Day 84 (VPA II total raw score)||0.94|-0.37|0.477
71877259|NCT02953639|143273398|SUPERIORITY||Treatment Difference|0.91||||0.028|TWO_SIDED|90.0|0.23|1.58|||Mixed Models Analysis|||Week 24 Day 168 (VPA II total raw score)||1.58|0.23|0.028
71877260|NCT02953639|143273398|SUPERIORITY||Treatment Difference|-0.3||||0.683|TWO_SIDED|90.0|-1.51|0.91|||Mixed Models Analysis|||Week 12 Day 84 (VPA II recognition total raw score)||0.91|-1.51|0.683
71877261|NCT02953639|143273398|SUPERIORITY||Treatment Difference|0.04||||0.954|TWO_SIDED|90.0|-1.13|1.22|||Mixed Models Analysis|||Week 24 Day 168 (VPA II recognition total raw score)||1.22|-1.13|0.954
71877262|NCT02953639|143273399|SUPERIORITY||Treatment Difference|1.45||||0.164|TWO_SIDED|90.0|-0.27|3.17|||Mixed Models Analysis|||Week 12 Day 84 (LM I)||3.17|-0.27|0.164
71877263|NCT02953639|143273399|SUPERIORITY||Treatment Difference|0.56||||0.559|TWO_SIDED|90.0|-1.02|2.14|||Mixed Models Analysis|||Week 24 Day 168 (LM I)||2.14|-1.02|0.559
71877264|NCT02953639|143273399|SUPERIORITY||Treatment Difference|0.12||||0.912|TWO_SIDED|90.0|-1.7|1.94|||Mixed Models Analysis|||Week 12 Day 84 (LM II)||1.94|-1.70|0.912
71877265|NCT02953639|143273399|SUPERIORITY||Treatment Difference|-0.36||||0.706|TWO_SIDED|90.0|-1.93|1.22|||Mixed Models Analysis|||Week 24 Day 168 (LM II)||1.22|-1.93|0.706
71877266|NCT02953639|143273400|SUPERIORITY||Treatment Difference|1.04||||0.527|TWO_SIDED|90.0|0.94|1.15|||Mixed Models Analysis|||Week 12 Day 84||1.15|0.94|0.527
71877267|NCT02953639|143273400|SUPERIORITY||Treatment Difference|1.04||||0.636|TWO_SIDED|90.0|0.92|1.17|||Mixed Models Analysis|||Week 24 Day 168||1.17|0.92|0.636
71877268|NCT02953639|143273401|SUPERIORITY||Treatment Difference|-1.36||||0.323|TWO_SIDED|90.0|-3.63|0.91|||Mixed Models Analysis|||Week 12 Day 84||0.91|-3.63|0.323
71877269|NCT02953639|143273401|SUPERIORITY||Treatment Difference|-0.95||||0.579|TWO_SIDED|90.0|-3.77|1.88|||Mixed Models Analysis|||Week 24 Day 168||1.88|-3.77|0.579
71877270|NCT02953639|143273402|SUPERIORITY||Treatment Difference|-0.67||||0.493|TWO_SIDED|90.0|-2.27|0.94|||Mixed Models Analysis|||Week 12 Day 84||0.94|-2.27|0.493
71877271|NCT02953639|143273402|SUPERIORITY||Treatment Difference|-0.12||||0.926|TWO_SIDED|90.0|-2.32|2.07|||Mixed Models Analysis|||Week 24 Day 168||2.07|-2.32|0.926
71877272|NCT02953639|143273403|SUPERIORITY||Treatment Difference|-0.02||||0.839|TWO_SIDED|90.0|-0.22|0.17|||Mixed Models Analysis|||Week 12 Day 84||0.17|-0.22|0.839
71877273|NCT02953639|143273403|SUPERIORITY||Treatment Difference|-0.06||||0.625|TWO_SIDED|90.0|-0.27|0.15|||Mixed Models Analysis|||Week 24 Day 168||0.15|-0.27|0.625
71877274|NCT02953639|143273404|SUPERIORITY||Treatment Difference|-0.03||||0.865|TWO_SIDED|90.0|-0.28|0.23|||Mixed Models Analysis|||Week 12 Day 84||0.23|-0.28|0.865
71877275|NCT02953639|143273404|SUPERIORITY||Treatment Difference|-0.01||||0.964|TWO_SIDED|90.0|-0.31|0.29|||Mixed Models Analysis|||Week 24 Day 168||0.29|-0.31|0.964
71685025|NCT04000360|142888399|SUPERIORITY||Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|0.91|<|0.0001|TWO_SIDED|95.0|-5.4|-1.85||This was the sole primary outcome. The test was conducted with a priori p-value threshold of α=0.05, with no multiple comparison adjustment.|Mixed Models Analysis|Test of equality of slopes with time (change in points/year) between aerobic exercise (AE) and usual and customary care (UCC) treatment arms.|Higher MDS-UPDRS III score reflects worse Parkinson's symptoms; increases reflect PD progression. The reported effect is the estimated difference between annual rates of change in scores of AE and UCC patients.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and AR(1) covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||-1.85|-5.40|<0.0001
71685026|NCT04000360|142888400|SUPERIORITY|Equality of annual slopes in squared 10 Meter Walk Test Comfortable Pace Velocity for the AE and UCC groups.|Difference in squared velocity slopes|12.07|STANDARD_ERROR_OF_MEAN|4.65||0.043|TWO_SIDED|95.0|3.1|21.32||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 Meter Walk Test fast pace velocity, TUG duration \& turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slope of meters\^2/second, in 100ths of meters\^2/second/year. The confidence interval is not multiple comparison adjusted. Parkinson's progression limits mobility; higher slope reflects less progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test velocity was squared ((meters/second)\^2) for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||21.32|3.10|0.043
71758575|NCT04922216|143019380|SUPERIORITY||Mean Difference (Net)|0.53||||0.08|TWO_SIDED|95.0|-0.06|1.13|||Mixed Models Analysis|DF (2,622)|Fixed message decision points coded as 0 (reference) and adaptive message decision points coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 3 (message decision points) using linear mixed models comparing the effect of weekly adaptive activity goals versus daily adaptive activity goals on weight change over time (from baseline to 3 months).||1.13|-0.06|0.08
71877276|NCT02953639|143273405|SUPERIORITY||Treatment Difference|3.27||||0.142|TWO_SIDED|90.0|-0.4|6.95|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Cognition \& Vitality Score)||6.95|-0.40|0.142
71877277|NCT02953639|143273405|SUPERIORITY||Treatment Difference|-2.32||||0.416|TWO_SIDED|90.0|-7.04|2.4|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Cognition \& Vitality Score)||2.40|-7.04|0.416
71877278|NCT02953639|143273405|SUPERIORITY||Treatment Difference|1.98||||0.394|TWO_SIDED|90.0|-1.86|5.83|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Psychosocial Score)||5.83|-1.86|0.394
71877279|NCT02953639|143273405|SUPERIORITY||Treatment Difference|0.71||||0.776|TWO_SIDED|90.0|-3.44|4.87|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Psychosocial Score)||4.87|-3.44|0.776
71877280|NCT02953639|143273405|SUPERIORITY||Treatment Difference|2.43||||0.254|TWO_SIDED|90.0|-1.09|5.94|||Mixed Models Analysis|||Week 12 Day 84 (SQLS Total Score)||5.94|-1.09|0.254
71877281|NCT02953639|143273405|SUPERIORITY||Treatment Difference|-0.57||||0.816|TWO_SIDED|90.0|-4.64|3.5|||Mixed Models Analysis|||Week 24 Day 168 (SQLS Total Score)||3.50|-4.64|0.816
71877282|NCT04196803|143273411|SUPERIORITY||||||<|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||<0.05
71877283|NCT04196803|143273412|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
71877284|NCT04196803|143273413|SUPERIORITY||||||>|0.05|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||>0.05
71877285|NCT04196803|143273414|SUPERIORITY||||||=|0.08|||||||Regression, Linear|P value was calculated using general linear model adjusted for age, sex, and baseline level||||||=0.08
71877286|NCT02319668|143273454|SUPERIORITY_OR_OTHER||Least square (LS) Mean difference|0.2||||0.2965|TWO_SIDED|95.0|-0.18|0.58|||ANCOVA|ANCOVA with treatment as factor and baseline as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||0.58|-0.18|0.2965
71877287|NCT01338415|143273474|OTHER||Hazard Ratio (HR)|1.438|||||TWO_SIDED|95.0|0.47|4.399|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||4.399|0.470|
71877288|NCT01338415|143273474|OTHER|||||||0.0526||||||p-value \<= 10% indicates that the covariate WHO FC at baseline is related to the time to PAH worsening|Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0526
71877289|NCT01338415|143273474|OTHER||Hazard Ratio (HR)|1.169||||||95.0|0.371|3.681|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||3.681|0.371|
71877290|NCT01338415|143273474|SUPERIORITY|||||||0.076||||||p-value \<= 10% indicates an improvement in model fit|log(e) likelihood ratio|||Test of improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.076
71877291|NCT01338415|143273475|OTHER||Hazard Ratio (HR)|1.935|||||TWO_SIDED|95.0|0.582|6.428|||Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)||6.428|0.582|
71877292|NCT01338415|143273475|OTHER|||||||0.0085|||||||Regression, Cox|p-value \<= 10% indicates that the covariate is related to the time to the time to death up to end-of-study||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate||||0.0085
71877293|NCT01338415|143273475|OTHER||Hazard Ratio (HR)|1.487|||||TWO_SIDED|95.0|0.437|5.052|||Regression, Cox|||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates||5.052|0.437|
71877294|NCT01338415|143273475|SUPERIORITY|||||||0.014|||||||log(e) likelihood ratio|p-value \<= 10% indicates an improvement in model fit||Test of the improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate||||0.014
71877295|NCT05395104|143273511|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.0865|||||TWO_SIDED|90.0|0.9724|1.2141||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2141|0.9724|
71877296|NCT05395104|143273513|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1174|||||TWO_SIDED|90.0|0.9784|1.2762||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2762|0.9784|
71877297|NCT05395104|143273514|OTHER|Ratio = Geometric least squares mean (test)/geometric least squares mean (reference)|Ratio|1.1239|||||TWO_SIDED|90.0|0.9887|1.2776||||||Midazolam + Cefiderocol: single 5-mg dose of midazolam + 2 g cefiderocol (Day 15)||1.2776|0.9887|
71877298|NCT01970488|143273524|NON_INFERIORITY_OR_EQUIVALENCE|Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.|Least Squares (LS) Mean Difference|-2.18|||||TWO_SIDED|95.0|-7.39|3.02||||||||3.02|-7.39|
71877299|NCT00789750|143273552|OTHER||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.084|<|0.001|TWO_SIDED|95.0|-0.49|-0.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.16|-0.49|<0.001
71877300|NCT00789750|143273553|OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.037|<|0.001|TWO_SIDED|95.0|-0.24|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.24|<0.001
71877301|NCT00789750|143273554|OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.056||0.0002|TWO_SIDED|95.0|-0.32|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.10|-0.32|0.0002
71877302|NCT00789750|143273555|OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.077|<|0.001|TWO_SIDED|95.0|-0.51|-0.2|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-0.20|-0.51|<0.001
71877303|NCT00789750|143273556|OTHER|||||||0.012|||||||Cochran-Mantel-Haenszel|||||||0.012
71877304|NCT00789750|143273557|OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|95.0|-21.93|-7.49|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-7.49|-21.93|<0.0001
71877305|NCT00789750|143273558|OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71877306|NCT00789750|143273559|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71877307|NCT00789750|143273560|OTHER|||||||0.132|||||||Cochran-Mantel-Haenszel|||||||0.132
71877308|NCT00789750|143273561|OTHER||||||<|0.001|||||||ANCOVA|||||||<0.001
71877309|NCT00789750|143273562|OTHER||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.15|<|0.001|TWO_SIDED|95.0|-20.62|-12.18|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-12.18|-20.62|<0.001
71877310|NCT00789750|143273563|OTHER||Mean Difference (Final Values)|1.8|STANDARD_ERROR_OF_MEAN|1.31||0.1652|TWO_SIDED|95.0|-0.75|4.39|||ANCOVA|||Treatment difference = Colesevelam - Placebo||4.39|-0.75|0.1652
71877311|NCT00789750|143273564|OTHER||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-13.44|-6.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-6.16|-13.44|<0.0001
71877312|NCT00789750|143273565|OTHER||Median Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|67.01||0.0004|TWO_SIDED|95.0|5.3|17.5|||ANCOVA||The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.|Treatment difference = Colesevelam - Placebo||17.5|5.3|0.0004
71917851|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.29||0.966|TWO_SIDED|95.0|-0.58|0.6|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.60|-0.58|0.966
71877313|NCT00789750|143273566|OTHER||Mean Difference (Final Values)|3.4|STANDARD_ERROR_OF_MEAN|0.93||0.0003|TWO_SIDED|95.0|1.58|5.23|||ANCOVA|||Treatment difference = Colesevelam - Placebo||5.23|1.58|0.0003
71877314|NCT00789750|143273567|OTHER||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.52|<|0.0001|TWO_SIDED|95.0|-11.75|-5.78|||ANCOVA|||Treatment difference = Colesevelam - Placebo||-5.78|-11.75|<0.0001
71877315|NCT00789750|143273568|OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|1.77||0.7286|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA|||Treatment difference = Colesevelam - Placebo||2.9|-4.1|0.7286
71877316|NCT00789750|143273569|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0653|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||Treatment difference = Colesevelam - Placebo||0.0|-0.4|0.0653
71877317|NCT00789750|143273570|OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.73||0.8862|TWO_SIDED|95.0|-1.5|1.3|||ANCOVA|||Treatment difference = Colesevelam - Placebo||1.3|-1.5|0.8862
71877318|NCT00307333|143273608|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 2 sided|||||||0.08
71877319|NCT00307333|143273609|SUPERIORITY_OR_OTHER|||||||0.47||95.0|||||t-test, 2 sided|||||||0.47
71877320|NCT00307333|143273610|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||||||0.31
71877321|NCT00307333|143273611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.61|0.99|||||HR = hazard for intervention / hazard for control|||0.99|0.61|
71877322|NCT03044249|143273625|SUPERIORITY||Response Ratio|4.0||||0.48|TWO_SIDED|90.0|-18.0|25.0|||Fisher Exact|||||25|-18|0.48
71877323|NCT03044249|143273627|SUPERIORITY||Mean Difference (Final Values)|-5.28||||0.14|TWO_SIDED|90.0|-11.16|0.61|||Mixed Models Analysis|||||0.61|-11.16|0.14
71877324|NCT03044249|143273628|SUPERIORITY||Mean Difference (Final Values)|-1.58||||0.37|TWO_SIDED|90.0|-4.47|1.31|||Mixed Models Analysis|||||1.31|-4.47|0.37
71877325|NCT03044249|143273632|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.94|TWO_SIDED|90.0|-2.0|1.84|||Mixed Models Analysis|||||1.84|-2.00|0.94
71877326|NCT01621542|143273642|OTHER|None specified||||||||||||||||The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|||
71877327|NCT01368042|143273645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7|STANDARD_DEVIATION|32.9||0.03|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.03
71877328|NCT01368042|143273646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.3|STANDARD_DEVIATION|57.2||0.05|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.05
71877329|NCT01368042|143273647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|STANDARD_DEVIATION|56.4||0.003|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)|||||0.003
71685027|NCT04000360|142888401|SUPERIORITY|Equality of annual slopes in 10 Meter Walk Test Fast Pace Velocity for the AE and UCC groups.|Difference in slopes|3.16|STANDARD_ERROR_OF_MEAN|2.68||0.48|TWO_SIDED|95.0|-2.1|8.42||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable pace, Timed Up and Go Test duration and turning velocity, Manual Dexterity Test.|Mixed Models Analysis||The reported effect is the difference in annual slopes of the AE and UCC treatment arms, in 100ths of meters/second/year. The confidence interval is not multiple comparison adjusted. Higher slope reflects less Parkinson's disease progression.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX.||8.42|-2.10|0.48
71685028|NCT04000360|142888402|SUPERIORITY|Equality of annual slopes of inverse Timed Up and Go Test duration, i.e., of TUG completions/second, the speed of completing the test.|Difference in slopes|4.04|STANDARD_ERROR_OF_MEAN|1.96||0.16|TWO_SIDED|95.0|0.2|7.89||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test turning velocity, and Manual Dexterity Test.|Mixed Models Analysis|Difference between estimated annual slopes in TUG completions/second/year for the AE and UCC groups.|Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a TUG completion/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was inverted to TUG completions/second. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||7.89|0.20|0.16
71685029|NCT04000360|142888403|SUPERIORITY|Test of equality of average turning velocities.|Difference in slopes.|1.85|STANDARD_ERROR_OF_MEAN|1.54||0.69|TWO_SIDED|95.0|-1.17|4.88||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: 10 meter walk test comfortable \& fast pace, Timed Up and Go Test duration, and Manual Dexterity Test.|Mixed Models Analysis||Timed Up and Go test speed is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes of average turning velocity for the AE and UCC groups in degrees/second/year.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||4.88|-1.17|0.69
71877330|NCT01368042|143273648|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_DEVIATION|30.5|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
71877331|NCT01368042|143273649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_DEVIATION|27.2|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
71877332|NCT01368042|143273650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.3|STANDARD_DEVIATION|35.3|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
71917852|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.41|STANDARD_ERROR_OF_MEAN|0.28||0.157|TWO_SIDED|95.0|-0.17|1.0|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.00|-0.17|0.157
71917853|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.18|STANDARD_ERROR_OF_MEAN|0.3||0.546|TWO_SIDED|95.0|-0.43|0.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.79|-0.43|0.546
71917854|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|0.28||0.818|TWO_SIDED|95.0|-0.51|0.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.64|-0.51|0.818
71877333|NCT01368042|143273651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.7|STANDARD_DEVIATION|34.8|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||<0.001
71877334|NCT01368042|143273652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|20.9||0.38|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.38
71877335|NCT01368042|143273653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.0|STANDARD_DEVIATION|32.0|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||<0.001
71877336|NCT01368042|143273654|SUPERIORITY_OR_OTHER|||||||0.03|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Physical functioning scale||||0.03
71877337|NCT01368042|143273654|SUPERIORITY_OR_OTHER|||||||0.02|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to physical health scale||||0.02
71877338|NCT01368042|143273654|SUPERIORITY_OR_OTHER|||||||0.01|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to emotional problems scale||||0.01
71877339|NCT01368042|143273654|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Energy/fatigue scale||||<0.001
71877340|NCT01368042|143273654|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Emotional well-being scale||||0.002
71877341|NCT01368042|143273654|SUPERIORITY_OR_OTHER|||||||0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Social functioning scale||||0.002
71917855|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.603|TWO_SIDED|95.0|-0.71|0.42|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.42|-0.71|0.603
71877342|NCT01368042|143273654|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Bodily pain scale||||<0.001
71877343|NCT01368042|143273654|SUPERIORITY_OR_OTHER|||||||0.56|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||General health perceptions scale||||0.56
71877344|NCT01368042|143273655|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0|STANDARD_DEVIATION|41.6||0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.001
71877345|NCT01368042|143273656|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|1.4||0.03|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.03
71877346|NCT01368042|143273657|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_DEVIATION|0.9||0.06|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)|||||0.06
71877347|NCT01368042|143273658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|1.7||0.84|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.84
71877348|NCT01368042|143273659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|16.5||0.67|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)|||||0.67
71877349|NCT01368042|143273660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.4|STANDARD_DEVIATION|324.8||0.02|||||||Wilcoxon signed rank test-paired samples||n= 215 (paired samples)|||||0.02
71877350|NCT01368042|143273661|SUPERIORITY_OR_OTHER|||||||0.12|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||||||0.12
71877351|NCT00955279|143273662|SUPERIORITY_OR_OTHER|||||||0.543|||||||ANCOVA|||||||0.543
71877352|NCT00955279|143273662|SUPERIORITY_OR_OTHER|||||||0.126|||||||ANCOVA|||||||0.126
71877353|NCT00955279|143273663|SUPERIORITY_OR_OTHER|||||||0.896|||||||Linear Contrasts Test|||||||0.896
71877354|NCT00955279|143273663|SUPERIORITY_OR_OTHER|||||||0.063|||||||Linear Contrasts Test|||||||0.063
71877355|NCT00955279|143273664|SUPERIORITY_OR_OTHER|||||||0.374|||||||Linear Contrasts Test|||||||0.374
71877356|NCT00955279|143273664|SUPERIORITY_OR_OTHER|||||||0.073|||||||Linear Contrasts Test|||||||0.073
71877357|NCT00955279|143273665|SUPERIORITY_OR_OTHER|||||||0.1931|||||||Fisher Exact|||||||0.1931
71877358|NCT00955279|143273665|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Fisher Exact|||||||0.2772
71877359|NCT00955279|143273666|SUPERIORITY_OR_OTHER|||||||0.451|||||||Linear Contrast Test|||||||0.451
71877360|NCT00955279|143273666|SUPERIORITY_OR_OTHER|||||||0.546|||||||Linear Contrast Test|||||||0.546
71877361|NCT02632721|143273681|OTHER||Probability of DLT rate in [0.16, 0.33)|0.081|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
71877362|NCT02632721|143273681|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
71877363|NCT02632721|143273681|OTHER||Probability of DLT rate in [0.16, 0.33)|0.028|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
71877364|NCT02632721|143273681|OTHER||Posterior probability of the DLT rate ly|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
71877365|NCT02632721|143273681|OTHER||Probability of DLT rate in [0.16, 0.33)|0.012|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.16, 0.33) (target dosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
71877366|NCT02632721|143273681|OTHER||Probability of DLT rate in [0.33, 1)|0.0|||||||||||||Posterior probability of the DLT rate lying in the interval \[0.33,1) (overdosing) is reported.|Bayesian logistic regression model (BLRM) with overdose control was used to determine the maximum tolerated dose (MTD), defined as highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.||||
71877367|NCT04207801|143273693|SUPERIORITY|||||||0.01|||||||Fisher Exact|||Efficacy of AUR101 was tested against placebo with respect to the primary endpoint (PASI75 response). A sample size of 25 in each of the three arms provided an 80% power with a one-sided Type I error of 0.05, if the true placebo response rate was 7% and the response rate on investigational arm(s) was 35%. The sample size was increased to 30 to account for \~ 15-20% dropouts over the study period.||||0.01
71877368|NCT02663271|143273704|SUPERIORITY|We used one-sample log rank test to compare to historical control.|Hazard Ratio (HR)|0.3|||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71877369|NCT03346057|143273713|OTHER||Estimated Difference in percentage|-6.7||||0.026|TWO_SIDED|95.0|-17.5|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by neuromuscular blocking agent (NMBA) and American Society of Anesthesiologists (ASA) class was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-17.5|0.026
71877370|NCT03346057|143273713|OTHER||Estimated Difference in percentage|-6.2||||0.058|TWO_SIDED|95.0|-17.3|0.2|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||0.2|-17.3|0.058
71877371|NCT03346057|143273713|OTHER||Estimated Difference in percentage|-2.0||||0.73|TWO_SIDED|95.0|-17.8|8.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||8.6|-17.8|0.730
71917856|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.27||0.495|TWO_SIDED|95.0|-0.37|0.74|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.74|-0.37|0.495
71758576|NCT04922216|143019380|SUPERIORITY||Mean Difference (Net)|0.32||||0.58|TWO_SIDED|95.0|-0.28|0.91|||Mixed Models Analysis|DF (2,622)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 4 (message decision rules) using linear mixed models comparing the effect of standard decision rules to adaptive decision rules on weight change over time (from baseline to 3 months).||0.91|-0.28|0.58
71877372|NCT03346057|143273714|OTHER||Estimated Difference in percentage|-14.9||||0.007|TWO_SIDED|95.0|-28.8|-4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-4.0|-28.8|0.007
71877373|NCT03346057|143273714|OTHER||Estimated Difference in percentage|-12.2||||0.036|TWO_SIDED|95.0|-26.1|-0.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||-0.8|-26.1|0.036
71877374|NCT03346057|143273714|OTHER||Estimated Difference in percentage|-9.9||||0.158|TWO_SIDED|95.0|-27.6|3.6|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||3.6|-27.6|0.158
71877375|NCT03346057|143273715|OTHER||Estimated Difference in percentage|-0.9||||0.637|TWO_SIDED|95.0|-9.4|4.0|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||4.0|-9.4|0.637
71877376|NCT03346057|143273715|OTHER||Estimated Difference in percentage|-2.1||||0.134|TWO_SIDED|95.0|-10.6|1.5|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||1.5|-10.6|0.134
71877377|NCT03346057|143273715|OTHER||Estimated Difference in percentage|-1.7||||0.577|TWO_SIDED|95.0|-14.7|5.8|||Stratified Miettinen & Nurminen method|||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference, 95% confidence interval, and p-value||5.8|-14.7|0.577
71877378|NCT03346057|143273716|OTHER||Estimated Difference in percentage|6.2|||||TWO_SIDED|95.0|-2.6|18.5||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||18.5|-2.6|
71877379|NCT03346057|143273716|OTHER||Estimated Difference in percentage|0.5|||||TWO_SIDED|95.0|-9.3|13.1||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||13.1|-9.3|
71877380|NCT03346057|143273716|OTHER||Estimated Difference in percentage|2.0|||||TWO_SIDED|95.0|-8.4|17.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||17.7|-8.4|
71877381|NCT03346057|143273717|OTHER||Estimated Difference in percentage|5.6|||||TWO_SIDED|95.0|-5.5|14.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||14.3|-5.5|
71877382|NCT03346057|143273717|OTHER||Estimated Difference in percentage|1.5|||||TWO_SIDED|95.0|-9.2|9.3||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||9.3|-9.2|
71877383|NCT03346057|143273717|OTHER||Estimated Difference in percentage|0.9|||||TWO_SIDED|95.0|-15.1|12.7||||||Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||12.7|-15.1|
71877384|NCT03346057|143273718|OTHER||Estimated Difference in percentage|-2.1|||||TWO_SIDED|95.0|-11.8|3.8||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 2 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||3.8|-11.8|
71877385|NCT03346057|143273718|OTHER||Estimated Difference in percentage|1.8|||||TWO_SIDED|95.0|-8.1|8.4||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 4 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||8.4|-8.1|
71917857|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.24|STANDARD_ERROR_OF_MEAN|0.27||0.375|TWO_SIDED|95.0|-0.31|0.8|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.80|-0.31|0.375
71917858|NCT00853112|143357733|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.25|STANDARD_ERROR_OF_MEAN|0.29||0.392|TWO_SIDED|95.0|-0.34|0.84|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.84|-0.34|0.392
71877386|NCT03346057|143273718|OTHER||Estimated Difference in percentage|1.1|||||TWO_SIDED|95.0|-13.5|11.1||||||The percentage of participants experiencing one or more ECIs was compared between the Sugammadex 16 mg/kg arm and the Neostigmine plus Glycopyrrolate arm. Miettinen \& Nurminen method stratified by NMBA and ASA was used to provide estimated between-treatment difference and 95% confidence interval||11.1|-13.5|
71877387|NCT01159912|143273719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.146||||0.009|TWO_SIDED|95.0|0.036|0.257|||ANCOVA|||||0.257|0.036|0.009
71877388|NCT01159912|143273719|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.145||||0.011|TWO_SIDED|95.0|0.033|0.257|||ANCOVA|||||0.257|0.033|0.011
71877389|NCT02456662|143273725|SUPERIORITY|Based on previous work as well as anecdotal data from our clinic population, we expect vomiting to occur in approximately 30% of our patients who take their doxycycline the night before their procedure. To have 80% power to detect a 50% decrease in nausea and vomiting, we will need 122 patients in each arm of the study.||||||0|||||||Chi-squared|||||||0.00
71917859|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|3.75||0.21|TWO_SIDED|95.0|-12.47|2.86|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.86|-12.47|0.210
71917860|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.47|STANDARD_ERROR_OF_MEAN|3.61||0.225|TWO_SIDED|95.0|-11.84|2.9|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.90|-11.84|0.225
71917861|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.73||0.332|TWO_SIDED|95.0|-11.28|3.93|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.93|-11.28|0.332
71917862|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.76||0.714|TWO_SIDED|95.0|-9.06|6.28|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.28|-9.06|0.714
71917863|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.01|STANDARD_ERROR_OF_MEAN|3.73||0.04|TWO_SIDED|95.0|-15.63|-0.39|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-0.39|-15.63|0.040
71917864|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|3.37||0.079|TWO_SIDED|95.0|-13.02|0.75|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||0.75|-13.02|0.079
71917865|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.85|STANDARD_ERROR_OF_MEAN|3.24||0.573|TWO_SIDED|95.0|-8.46|4.77|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||4.77|-8.46|0.573
71917866|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.67|STANDARD_ERROR_OF_MEAN|3.34||0.28|TWO_SIDED|95.0|-10.5|3.15|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.15|-10.50|0.280
71917867|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.39|STANDARD_ERROR_OF_MEAN|3.38||0.684|TWO_SIDED|95.0|-8.28|5.51|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.51|-8.28|0.684
71917868|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.17|STANDARD_ERROR_OF_MEAN|3.35||0.021|TWO_SIDED|95.0|-15.01|-1.34|||Longitudinal analysis|||mPAP at Hour 2: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.||-1.34|-15.01|0.021
71917869|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|3.7||0.727|TWO_SIDED|95.0|-8.86|6.25|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||6.25|-8.86|0.727
71917870|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.85|STANDARD_ERROR_OF_MEAN|3.56||0.183|TWO_SIDED|95.0|-12.12|2.42|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.42|-12.12|0.183
71917871|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.01|STANDARD_ERROR_OF_MEAN|3.67||0.112|TWO_SIDED|95.0|-13.51|1.49|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.49|-13.51|0.112
71917872|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|3.71||0.928|TWO_SIDED|95.0|-7.91|7.23|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||7.23|-7.91|0.928
71917873|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-9.01|STANDARD_ERROR_OF_MEAN|3.68||0.02|TWO_SIDED|95.0|-16.52|-1.5|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.50|-16.52|0.020
71917874|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|3.79||0.136|TWO_SIDED|95.0|-13.55|1.94|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||1.94|-13.55|0.136
71917875|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.82|STANDARD_ERROR_OF_MEAN|3.65||0.303|TWO_SIDED|95.0|-11.27|3.63|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||3.63|-11.27|0.303
71917876|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.17|STANDARD_ERROR_OF_MEAN|3.77||0.18|TWO_SIDED|95.0|-12.87|2.52|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||2.52|-12.87|0.180
71917877|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.56|STANDARD_ERROR_OF_MEAN|3.8||0.506|TWO_SIDED|95.0|-10.31|5.2|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||5.20|-10.31|0.506
71917878|NCT00853112|143357734|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.84|STANDARD_ERROR_OF_MEAN|3.77||0.026|TWO_SIDED|95.0|-16.54|-1.14|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.||-1.14|-16.54|0.026
71917879|NCT01553591|143357742|SUPERIORITY|||||||0.014||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.014
71917880|NCT01553591|143357742|SUPERIORITY|||||||0.004||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.004
71917881|NCT01553591|143357743|SUPERIORITY|||||||0.112||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||0.112
71917882|NCT01553591|143357743|SUPERIORITY||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.||||<0.001
71917883|NCT00958191|143357767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 1 year||||<0.0001
71917884|NCT00958191|143357767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 3 years||||<0.0001
71917885|NCT00958191|143357767|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in HHS from pre-op to 5 years||||<0.0001
71917886|NCT00958191|143357768|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 1 year||||<0.0001
71917887|NCT00958191|143357768|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 3 years||||<0.0001
71917888|NCT00958191|143357768|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 5 years||||<0.0001
71917889|NCT00958191|143357769|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 1 year||||<0.0001
71917890|NCT00958191|143357769|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 3 years||||<0.0001
71758577|NCT04922216|143019380|SUPERIORITY||Mean Difference (Net)|-0.32||||0.55|TWO_SIDED|95.0|-0.91|0.28|||Mixed Models Analysis|DF (2,622)|No choice points coded as 0 (reference) and Choice coded as 1; a positive estimation parameter indicates that the reference group had greater (more negative) weight loss.|ITT analysis for factor 5 (participant choice) using linear mixed models comparing the effect of no participant message choice versus participant message choice on weight change over time (from baseline to 3 months).||0.28|-0.91|0.55
71877390|NCT01353079|143273727|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.834|||<|0.05|TWO_SIDED|95.0|-1.298|-0.369|||ANCOVA|||||-0.369|-1.298|<0.05
71877391|NCT01353079|143273728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.857|||<|0.05|TWO_SIDED|95.0|-1.388|-0.326|||ANCOVA|||||-0.326|-1.388|<0.05
71877392|NCT01353079|143273729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.771|||<|0.05|TWO_SIDED|95.0|-1.213|-0.329|||ANCOVA|||||-0.329|-1.213|<0.05
71877393|NCT01353079|143273730|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.788|||<|0.05|TWO_SIDED|95.0|-1.291|-0.284|||ANCOVA|||||-0.284|-1.291|<0.05
71877394|NCT04223791|143273744|NON_INFERIORITY|Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points.|Estimated difference|0.31|||<|0.001|TWO_SIDED|95.0|-1.19|1.96||p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method.|Unstratified Miettinen and Nurminen||Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||1.96|-1.19|<.001
71877395|NCT04223791|143273745|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-3.5|||||TWO_SIDED|95.0|-10.4|3.4|||||Based on Miettinen and Nurminen method|||3.4|-10.4|
71877396|NCT04223791|143273746|OTHER|Difference between treatment groups|Difference in % (DOR/ISL- BIC/FTC/TAF)|-0.02|||||TWO_SIDED|95.0|-2.7|2.6|||||Based on Miettinen and Nurminen method|||2.6|-2.7|
71877397|NCT04223791|143273759|SUPERIORITY||Treatment Difference|-0.3||||0.392|TWO_SIDED|95.0|-0.99|0.39|||ANCOVA|Model included terms for baseline weight, sex, race, and treatment.|Treatment difference for DOR/ISL group-BIC/FTC/TAF group.|||0.39|-0.99|0.392
71877398|NCT01540825|143273786|SUPERIORITY_OR_OTHER||Slope|1.2472|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|95.0|1.1831|1.3112|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.||1.3112|1.1831|
71877399|NCT01540825|143273788|SUPERIORITY_OR_OTHER||Slope|1.1626|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.1195|1.2057|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0- tz was analysed.||1.2057|1.1195|
71877400|NCT01540825|143273789|SUPERIORITY_OR_OTHER||Slope|1.151|STANDARD_ERROR_OF_MEAN|0.0215|||TWO_SIDED|95.0|1.108|1.1941|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed||1.1941|1.1080|
71877401|NCT05097716|143273802|EQUIVALENCE|90% CI|ratio of adjusted geometric means|103.01|||||TWO_SIDED|90.0|96.66|109.77|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||109.77|96.66|
71877402|NCT05097716|143273803|EQUIVALENCE|90% CI|ratio of adjusted geometric means|99.05|||||TWO_SIDED|90.0|92.01|106.62|||||The comparison was Test vs. Reference (Ritlecitinib + Tolbutamide vs. Tolbutamide).|||106.62|92.01|
71877403|NCT01372150|143273816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.226|TWO_SIDED|95.0|-1.06|4.48|||Mixed-effects model for repeated measure|Mixed-effects model for repeated measures (MMRM)|Adjusted mean difference = placebo - fluoxetine|Fluoxetine versus Placebo||4.48|-1.06|0.226
71877404|NCT01372150|143273816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.739|TWO_SIDED|95.0|-3.23|2.3|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||2.30|-3.23|0.739
71877405|NCT01372150|143273817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.224|TWO_SIDED|95.0|-0.11|0.46|||MMRM||Adjusted mean difference = Placebo - Fluoxetine|Fluoxetine versus Placebo||0.46|-0.11|0.224
71877406|NCT01372150|143273817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.944|TWO_SIDED|95.0|-0.29|0.27|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo||0.27|-0.29|0.944
71877407|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.924||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 1||||0.924
71877408|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.698||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 1||||0.698
71877409|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.214||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 2||||0.214
71877410|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.113||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 2||||0.113
71877411|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.314||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 3||||0.314
71877412|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.659||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 3||||0.659
71877413|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.577||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 4||||0.577
71758578|NCT04922216|143019381|SUPERIORITY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.7|1.39|||Chi-squared|DF (1)|Standard dietary monitoring coded as 0 (reference) and simplified dietary monitoring coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard dietary monitoring and simplified dietary monitoring (factor 1).||1.39|0.70|0.95
71877414|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.187||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 4||||0.187
71877415|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.051||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 6||||0.051
71917891|NCT00958191|143357769|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 5 years||||<0.0001
71917892|NCT00958191|143357770|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 1 year||||<0.0001
71917893|NCT00958191|143357770|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Phyiscal Component Score from preop to 3 year||||<0.0001
71917894|NCT00958191|143357770|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 5 year||||<0.0001
71917895|NCT00958191|143357770|SUPERIORITY_OR_OTHER|||||||0.0242|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 1 year||||0.0242
71917896|NCT00958191|143357770|SUPERIORITY_OR_OTHER|||||||0.0247|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 3 year||||0.0247
71917897|NCT00958191|143357770|SUPERIORITY_OR_OTHER|||||||0.1372|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 5 year||||0.1372
71917898|NCT00958191|143357771|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 1 year||||<0.0001
71917899|NCT00958191|143357771|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 3 year||||<0.0001
71917900|NCT00958191|143357771|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change in LEAS Score from preop to 5 year||||<0.0001
71917901|NCT00397631|143357895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.12|<|0.001||95.0|-1.13|-0.65|||ANCOVA|Model terms: treatment, baseline HbA1c||||-0.65|-1.13|<0.001
71917902|NCT00397631|143357896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.8|STANDARD_ERROR_OF_MEAN|3.87|<|0.001||95.0|-30.4|-15.2|||ANCOVA|Model terms: treatment, baseline FPG||||-15.2|-30.4|<0.001
71917903|NCT00397631|143357897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-44.7|STANDARD_ERROR_OF_MEAN|6.37|<|0.001||95.0|-57.2|32.2|||ANCOVA|Model terms: treatment, baseline 2-hour PPG||||32.2|-57.2|<0.001
71917904|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-1.17|||||TWO_SIDED|95.0|-25.61|23.27|||||Comparison for fasting, Day 7|An estimation approach was used.||23.27|-25.61|
71917905|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|13.22|||||TWO_SIDED|95.0|-9.84|36.27|||||Comparison for fasting, Day 7|An estimation approach was used.||36.27|-9.84|
71917906|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.77|||||TWO_SIDED|95.0|-41.43|-2.1|||||Comparison for fasting, Day 7|An estimation approach was used.||-2.10|-41.43|
71917907|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.1|||||TWO_SIDED|95.0|-42.63|-3.57|||||Comparison for fasting, Day 7|An estimation approach was used.||-3.57|-42.63|
71917908|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.79|||||TWO_SIDED|95.0|-30.85|7.28|||||Comparison for fasting, Day 7|An estimation approach was used.||7.28|-30.85|
71917909|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.04|||||TWO_SIDED|95.0|-27.66|7.57|||||Comparison for fasting, Day 7|An estimation approach was used.||7.57|-27.66|
71917910|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.14|||||TWO_SIDED|95.0|-37.72|7.43|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.43|-37.72|
71917911|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-2.1|||||TWO_SIDED|95.0|-23.66|19.45|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||19.45|-23.66|
71917912|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-20.66|||||TWO_SIDED|95.0|-38.75|-2.57|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-2.57|-38.75|
71917913|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.7|||||TWO_SIDED|95.0|-39.7|-3.71|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-3.71|-39.70|
71917914|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.62|||||TWO_SIDED|95.0|-28.62|7.38|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||7.38|-28.62|
71917915|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-26.03|||||TWO_SIDED|95.0|-41.94|-10.12|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.||-10.12|-41.94|
71917916|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-12.1|||||TWO_SIDED|95.0|-33.56|9.36|||||Comparison for fasting, Day 14|An estimation approach was used.||9.36|-33.56|
71917917|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.33|||||TWO_SIDED|95.0|-15.91|24.57|||||Comparison for fasting, Day 14|An estimation approach was used.||24.57|-15.91|
71917918|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-25.29|||||TWO_SIDED|95.0|-42.56|-8.02|||||Comparison for fasting, Day 14|An estimation approach was used.||-8.02|-42.56|
71917919|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.97|||||TWO_SIDED|95.0|-37.12|-2.82|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.82|-37.12|
71917920|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.82|||||TWO_SIDED|95.0|-38.56|-5.08|||||Comparison for fasting, Day 14|An estimation approach was used.||-5.08|-38.56|
71917921|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-18.01|||||TWO_SIDED|95.0|-33.48|-2.55|||||Comparison for fasting, Day 14|An estimation approach was used.||-2.55|-33.48|
71917922|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.2|||||TWO_SIDED|95.0|-33.21|10.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||10.81|-33.21|
71917923|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.8|||||TWO_SIDED|95.0|-16.22|25.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||25.81|-16.22|
71917924|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.23|||||TWO_SIDED|95.0|-32.86|2.41|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||2.41|-32.86|
71917925|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-17.01|||||TWO_SIDED|95.0|-34.56|0.53|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||0.53|-34.56|
71917926|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.94|||||TWO_SIDED|95.0|-41.49|-6.39|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-6.39|-41.49|
71917927|NCT02202161|143357898|SUPERIORITY_OR_OTHER|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.45|||||TWO_SIDED|95.0|-34.96|-3.93|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.||-3.93|-34.96|
71917928|NCT02202161|143357913|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.17|||||TWO_SIDED|90.0|0.92|1.49|||||Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|0.92|
71917929|NCT02202161|143357913|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.89|1.38|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.38|0.89|
71877416|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.266||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 6||||0.266
71877417|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.095||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 8||||0.095
71877418|NCT01372150|143273818|SUPERIORITY_OR_OTHER|||||||0.852||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 8||||0.852
71877419|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.186|TWO_SIDED|95.0|0.226|1.335|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 1||1.335|0.226|0.186
71877420|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.984|TWO_SIDED|95.0|0.382|2.567|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 1||2.567|0.382|0.984
71877421|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.795||||0.462|TWO_SIDED|95.0|0.431|1.465|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 2||1.465|0.431|0.462
71877422|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.726||||0.297|TWO_SIDED|95.0|0.399|1.324|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 2||1.324|0.399|0.297
71877423|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.688||||0.194|TWO_SIDED|95.0|0.391|1.21|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 3||1.210|0.391|0.194
71877424|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.732||||0.272|TWO_SIDED|95.0|0.419|1.277|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 3||1.277|0.419|0.272
71877425|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.748||||0.313|TWO_SIDED|95.0|0.426|1.314|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 4||1.314|0.426|0.313
71877426|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.663||||0.157|TWO_SIDED|95.0|0.376|1.171|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 4||1.171|0.376|0.157
71877427|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.579||||0.072|TWO_SIDED|95.0|0.319|1.05|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 6||1.050|0.319|0.072
71877428|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.64||||0.135|TWO_SIDED|95.0|0.356|1.149|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 6||1.149|0.356|0.135
71917930|NCT02202161|143357913|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.05|||||TWO_SIDED|90.0|0.87|1.27|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.27|0.87|
71877429|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.465||||0.017|TWO_SIDED|95.0|0.249|0.871|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 8||0.871|0.249|0.017
71877430|NCT01372150|143273819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.751||||0.343|TWO_SIDED|95.0|0.415|1.357|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 8||1.357|0.415|0.343
71877431|NCT05215262|143273822|SUPERIORITY||Mean Difference (Final Values)|1.87||||0.04|TWO_SIDED|95.0|0.04|3.17|||Mixed Models Analysis|||||3.17|0.04|0.04
71877432|NCT05215262|143273822|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.82|TWO_SIDED|95.0|-1.59|1.99|||Mixed Models Analysis|||||1.99|-1.59|0.82
71877433|NCT05215262|143273822|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.2|TWO_SIDED|95.0|-0.89|4.23|||Mixed Models Analysis|||Difference-in-differences results, comparing GSES scores between the Intervention and Standard of Care groups at the three-month time point.||4.23|-0.89|0.20
71877434|NCT00718549|143273833|SUPERIORITY|||||||0.028|||||||Log Rank|||||||0.028
71877435|NCT00718549|143273833|SUPERIORITY||Hazard Ratio (HR)|0.418||||0.033||95.0|0.187|0.933|||Cox's proportional hazards regression|||Univariate comparison||0.933|0.187|0.033
71877436|NCT00718549|143273833|SUPERIORITY||Hazard Ratio (HR)|0.052||||0.111|TWO_SIDED|95.0|0.001|1.972|||Cox's proportional hazards model|||Multivariate Comparison||1.972|0.001|0.111
71877437|NCT00718549|143273834|SUPERIORITY||Odds Ratio (OR)|3.654||||0.155|TWO_SIDED|95.0|0.674|28.337|||Regression, Logistic|||Week 129: Univariate Comparison||28.337|0.674|0.155
71877438|NCT00718549|143273835|SUPERIORITY||Odds Ratio (OR)|0.625||||0.634|TWO_SIDED|95.0|0.073|4.114|||Regression, Logistic|||Week 129: Univariate comparison||4.114|0.073|0.634
71877439|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|0.769||||0.752|TWO_SIDED|95.0|0.151|3.92|||Cox's proportional hazards model|||Multivariate Comparison: Age \<60 years versus Age \>/=60 years||3.920|0.151|0.752
71877440|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|0.068||||0.128|TWO_SIDED|95.0|0.002|2.158|||Cox's proportional hazards model|||Multivariate Comparison: Sex: Female versus Male||2.158|0.002|0.128
71877441|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|2.282||||0.728|TWO_SIDED|95.0|0.022|240.864|||Cox's proportional hazards model|||Multivariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||240.864|0.022|0.728
71877442|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|26.275||||0.048|TWO_SIDED|95.0|1.036|666.708|||Cox's proportional hazards model|||Multivariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||666.708|1.036|0.048
71877443|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.417|TWO_SIDED|95.0|0.005|9.1|||Cox's proportional hazards model|||Multivariate Comparison: ZAP-70 Expression Negative versus Positive||9.100|0.005|0.417
71877444|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|0.197||||0.134|TWO_SIDED|95.0|0.024|1.647|||Cox's proportional hazards model|||Multivariate Comparison: CD38 Expression Negative versus Positive||1.647|0.024|0.134
71877445|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|8.373||||0.426|TWO_SIDED|95.0|0.045|1568.717|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 17p No versus Yes||1568.717|0.045|0.426
71917931|NCT02202161|143357913|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.03|1.52|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.52|1.03|
71917932|NCT02202161|143357913|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||TWO_SIDED|90.0|1.04|1.5|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.50|1.04|
71917933|NCT02202161|143357913|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||TWO_SIDED|90.0|0.94|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.94|
71917934|NCT02202161|143357915|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|0.88|||||TWO_SIDED|90.0|0.68|1.13|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.13|0.68|
71917935|NCT02202161|143357915|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.82|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.31|0.82|
71917936|NCT02202161|143357915|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||TWO_SIDED|90.0|0.85|1.26|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.26|0.85|
71917937|NCT02202161|143357915|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.19|||||TWO_SIDED|90.0|0.97|1.45|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.45|0.97|
71917938|NCT02202161|143357915|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.23|||||TWO_SIDED|90.0|1.01|1.49|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.49|1.01|
71917939|NCT02202161|143357915|SUPERIORITY_OR_OTHER|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.24|||||TWO_SIDED|90.0|1.04|1.48|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.|||1.48|1.04|
71917940|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.91|1.17|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.17|0.91|
71917941|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.88|||||TWO_SIDED|95.0|0.78|0.98|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.98|0.78|
71917942|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.86|||||TWO_SIDED|95.0|0.78|0.95|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.95|0.78|
71917943|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.75|||||TWO_SIDED|95.0|0.68|0.83|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.83|0.68|
71917944|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.76|0.92|||||Comparison for Day 7, cholesterol|An estimation approach was used.||0.92|0.76|
71917945|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.92|1.1|||||Comparison for Day 7, cholesterol|An estimation approach was used.||1.10|0.92|
71917946|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.95|1.19|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.19|0.95|
71917947|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.04|||||TWO_SIDED|95.0|0.94|1.16|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.16|0.94|
71917948|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.88|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.88|
71877446|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|0.438||||0.733|TWO_SIDED|95.0|0.004|50.334|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 13q No versus Yes||50.334|0.004|0.733
71877447|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|2.621||||0.463|TWO_SIDED|95.0|0.2|34.422|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 11q No versus Yes||34.422|0.200|0.463
71877448|NCT00718549|143273836|SUPERIORITY||Hazard Ratio (HR)|0.288||||0.397|TWO_SIDED|95.0|0.016|5.122|||Cox's proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 12q No versus Yes||5.122|0.016|0.397
71877449|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.982||||0.969|TWO_SIDED|95.0|0.393|2.531|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.531|0.393|0.969
71877450|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.552||||0.26|TWO_SIDED|95.0|0.183|1.488|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||1.488|0.183|0.260
71877451|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.465||||0.121|TWO_SIDED|95.0|0.177|1.242|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||1.242|0.177|0.121
71877452|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.374||||0.045|TWO_SIDED|95.0|0.137|0.957|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||0.957|0.137|0.045
71877453|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|8.809||||0.04|TWO_SIDED|95.0|1.655|163.316|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||163.316|1.655|0.040
71877454|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.921||||0.887|TWO_SIDED|95.0|0.287|2.851|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||2.851|0.287|0.887
71877455|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.932||||0.936|TWO_SIDED|95.0|0.186|6.839|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||6.839|0.186|0.936
71877456|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|1.88||||0.199|TWO_SIDED|95.0|0.719|5.012|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||5.012|0.719|0.199
71877457|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|1.668||||0.375|TWO_SIDED|95.0|0.566|5.649|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.649|0.566|0.375
71877458|NCT00718549|143273837|SUPERIORITY||Odds Ratio (OR)|0.957||||0.961|TWO_SIDED|95.0|0.173|7.275|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||7.275|0.173|0.961
71877459|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|1.31||||0.768|TWO_SIDED|95.0|0.237|10.189|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||10.189|0.237|0.768
71877460|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|0.667||||0.657|TWO_SIDED|95.0|0.086|3.653|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||3.653|0.086|0.657
71877461|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|1.68||||0.655|TWO_SIDED|95.0|0.229|34.486|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||34.486|0.229|0.655
71877462|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|0.635||||0.595|TWO_SIDED|95.0|0.117|3.73|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||3.730|0.117|0.595
71877463|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.164|8.102|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive||8.102|0.164|1.000
71877464|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|0.857||||0.882|TWO_SIDED|95.0|0.093|6.636|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||6.636|0.093|0.882
71877465|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|0.154||||0.216|TWO_SIDED|95.0|0.005|4.405|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes||4.405|0.005|0.216
71877466|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|0.361||||0.396|TWO_SIDED|95.0|0.017|2.971|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||2.971|0.017|0.396
71877467|NCT00718549|143273838|SUPERIORITY||Odds Ratio (OR)|0.75||||0.776|TWO_SIDED|95.0|0.103|6.572|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||6.572|0.103|0.776
71877468|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|0.528||||0.357|TWO_SIDED|95.0|0.131|2.114|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||2.114|0.131|0.357
71877469|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|0.694||||0.623|TWO_SIDED|95.0|0.138|2.8|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||2.800|0.138|0.623
71877470|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|4.0||||0.097|TWO_SIDED|95.0|0.901|28.158|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||28.158|0.901|0.097
71877471|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|4.2||||0.233|TWO_SIDED|95.0|0.484|89.588|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||89.588|0.484|0.233
71877472|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|0.844||||0.826|TWO_SIDED|95.0|0.161|3.681|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||3.681|0.161|0.826
71877473|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|1.067||||0.933|TWO_SIDED|95.0|0.246|5.581|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||5.581|0.246|0.933
71877474|NCT00718549|143273839|SUPERIORITY||Odds Ratio (OR)|0.727||||0.794|TWO_SIDED|95.0|0.08|15.779|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||15.779|0.080|0.794
71877475|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|1.923||||0.591|TWO_SIDED|95.0|0.225|41.751|||Regression, Logistic|||Univariate Comparison: Age \<60 years versus Age \>/=60 years||41.751|0.225|0.591
71758579|NCT04922216|143019381|SUPERIORITY||Odds Ratio (OR)|1.46||||0.03|TWO_SIDED|95.0|1.03|2.05|||Chi-squared|DF (1)|Weekly adaptive activity goals coded as 0 (reference) and daily adaptive activity goals coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between weekly adaptive activity goals and daily adaptive activity goals (factor 2).||2.05|1.03|0.03
71877476|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|1.3||||0.796|TWO_SIDED|95.0|0.147|9.222|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male||9.222|0.147|0.796
71877477|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|3.2||||0.338|TWO_SIDED|95.0|0.375|69.479|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin \>/= Median Value versus Beta-2-Microglobulin \<Median Value||69.479|0.375|0.338
71877478|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|2.333||||0.486|TWO_SIDED|95.0|0.201|29.008|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive||29.008|0.201|0.486
71877479|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|0.667||||0.691|TWO_SIDED|95.0|0.074|4.722|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes||4.722|0.074|0.691
71877480|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|1.5||||0.691|TWO_SIDED|95.0|0.212|13.563|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes||13.563|0.212|0.691
71877481|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.076|24.621|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes||24.621|0.076|1.000
71877482|NCT00718549|143273840|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.099|22.791|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV||22.791|0.099|1.000
71877483|NCT00953719|143273898|NON_INFERIORITY_OR_EQUIVALENCE|The prospectively planned primary endpoint analysis was a non-inferiority test of covariate adjusted 24 month or later Harris Hip score means with a 5 point non-inferiority margin. A prospective power analysis with an anticipated Harris Hip score standard deviation of 10.08 (for both treatment groups) indicated that sample sizes of 134 and 67 would provide approximately 95% statistical power for this non-inferiority test with a type 1 error rate of 5%.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.24|<|0.001|ONE_SIDED|95.0|-1.4||||ANCOVA||||||-1.40|<0.001
71877484|NCT00953719|143273904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.079||||0.952||95.0|||||Mixed Models Analysis|SAS PROC MIXED was used with an ante-dependence covariance structure.||A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.||||0.952
71877485|NCT01478360|143273911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.5392|TWO_SIDED|90.0|-0.617|0.285|||Mixed Models Analysis|||||0.285|-0.617|0.5392
71877486|NCT02289352|143273912|EQUIVALENCE|If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, +20%\], then bioequivalence of the Test product to the Reference product is considered to have been demonstrated.|Mean Difference (Net)|-0.58|||||TWO_SIDED|90.0|-6.49|5.33||||||||5.33|-6.49|
71877487|NCT02289352|143273912|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71877488|NCT02289352|143273912|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71758580|NCT04922216|143019381|SUPERIORITY||Odds Ratio (OR)|0.85||||0.36|TWO_SIDED|95.0|0.6|1.2|||Chi-squared|DF (1)|Fixed decision points coded as 0 (reference) and adaptive decision points coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between fixed message decision points and adaptive message decision points (factor 3).||1.20|0.60|0.36
71877489|NCT02289352|143273913|EQUIVALENCE|"The secondary efficacy variable is the proportion of patients with a clinical response of treatment success on Day 1.~If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both the CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range \[-20%, 20%\], then bioequivalence of the Test to Reference product is considered to have been demonstrated."|Mean Difference (Net)|6.94|||||TWO_SIDED|90.0|-1.54|15.41||||||||15.41|-1.54|
71877490|NCT02289352|143273913|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71877491|NCT02289352|143273913|SUPERIORITY|||||||0.0045|||||||t-test, 2 sided|||||||0.0045
71877492|NCT01177384|143273914|SUPERIORITY_OR_OTHER||Difference in least squares mean|-0.62|||<|0.001|TWO_SIDED|95.0|-0.79|-0.44||The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.|ANCOVA|||||-0.44|-0.79|<.001
71877493|NCT01177384|143273915|SUPERIORITY_OR_OTHER||Difference in least squares mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.8|-7.0||The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.|ANCOVA|||||-7.0|-21.8|<.001
71877494|NCT01849497|143273918|SUPERIORITY_OR_OTHER||Treatment Difference|-6.8|||||TWO_SIDED|95.0|-16.3|2.0||||||||2.0|-16.3|
71877495|NCT01849497|143273919|SUPERIORITY_OR_OTHER||LS Mean Treatment Difference|-3.7|STANDARD_ERROR_OF_MEAN|3.38|||TWO_SIDED|95.0|-10.38|2.99||||||||2.99|-10.38|
71877496|NCT00911625|143273957|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|9.502||0.958|TWO_SIDED|95.0|-19.341|18.341|||t-test, 2 sided|||The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level||18.341|-19.341|.958
71877497|NCT00911625|143273958|SUPERIORITY||Odds Ratio (OR)|0.438||||0.0828|TWO_SIDED|95.0|0.172|1.114|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.||1.114|0.172|.0828
71877498|NCT00529451|143273962|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-2.44|||||TWO_SIDED|95.0|-3.63|-1.25||||||||-1.25|-3.63|
71877499|NCT00529451|143273963|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-0.86|||||TWO_SIDED|95.0|-2.06|0.34||||||||0.34|-2.06|
71877500|NCT00529451|143273964|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-1.48|||||TWO_SIDED|95.0|-2.67|-0.28||||||||-0.28|-2.67|
71685030|NCT04000360|142888404|SUPERIORITY|Test of equality of slopes of test performance speed (peg transfers/second/year) for AE and UCC groups.|Difference in slopes.|-3.62|STANDARD_ERROR_OF_MEAN|10.23||0.72|TWO_SIDED|95.0|-23.68|16.45||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other motor domain secondary outcomes: Timed Up and Go Test (TUG) duration \& turning velocity and 10 meter walk test comfortable \& fast pace.|Mixed Models Analysis||Manual dexterity expressed as peg transfers/second is expected to decline with Parkinson's progression. The reported effect is the difference between estimated annual slopes for the AE and UCC groups in 1000ths of a peg transfer/second/year.|Linear mixed model for baseline, 6 and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was transformed for modeling to peg transfers/second (18/seconds). Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||16.45|-23.68|0.72
71685031|NCT04000360|142888405|SUPERIORITY|Test of equality of slopes of squared match scores (matches\^2/year) between AE and UCC groups.|Difference in slopes.|-96.91|STANDARD_ERROR_OF_MEAN|69.12||0.48|TWO_SIDED|95.0|-232.41|38.6||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Visual Memory Test and Trail Making Test B to A duration ratio.|Mixed Models Analysis||Processing speed is expected to decline with Parkinson's, hence duration of the test to increase. The reported effect is the difference in annual slopes (matches\^2/year) between the AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and heterogeneous compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, test duration was squared (matches\^2) for analysis. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||38.60|-232.41|0.48
71685032|NCT04000360|142888406|SUPERIORITY|Test of equality of annual slopes of log(TMT B to TMT A duration ratio) for AE and UCC groups.|Difference in slopes|-3.42|STANDARD_ERROR_OF_MEAN|6.06||1|TWO_SIDED|95.0|-15.31|8.46||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Visual Memory Test.|Mixed Models Analysis||Visual attention and set switching speed decline with Parkinson's, hence duration of Trail Making Test B increases. The reported effect is the difference in annual slopes of (log TMT B/TMT A), i.e., change/year, between AE and UCC treatment arms.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the ratios were transformed to their natural logarithms for modeling. Study sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||8.46|-15.31|1.00
71685033|NCT04000360|142888407|SUPERIORITY|Test of equality of annual slopes of squared test score.|Difference in slopes|0.16|STANDARD_ERROR_OF_MEAN|1.4||0.91|TWO_SIDED|95.0|-2.58|2.91||Family-wise error controlled at α=0.05 by Holm-Bonferroni adjustment for other non-motor domain secondary outcomes: Processing Speed Test and Trail Making Test Ratio.|Mixed Models Analysis||Visual memory declines with Parkinson's, hence the score declines. The reported effect is the difference in annual slopes, i.e., changes in mean score\^2/year, for AE and UCC treatment arms, shown in hundreds. Higher slope indicates slower decline.|Linear mixed model for baseline, 6 month, and 12 month data, with fixed effects of clinical site, treatment, and linear time nested in treatment arm, and compound symmetry covariance structure, fit by residual pseudolikelihood maximization (RSPL) in SAS PROC GLIMMIX. To reduce skew and better meet modeling assumptions, the score was squared for statistical modeling. Sample size was based on the primary outcome, and power was not calculated for this and other outcomes.||2.91|-2.58|0.91
71685034|NCT03725033|142888421|SUPERIORITY|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.0028
71685035|NCT03725033|142888422|SUPERIORITY|||||||0.0805|||||||Fisher Exact|||||||0.0805
71685036|NCT03725033|142888423|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.99
71685037|NCT03725033|142888424|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between baseline and after 12 weeks row.||||0.79
71685038|NCT00094536|142888500|SUPERIORITY_OR_OTHER|||||||0.271|||||||1-sided z-test|1-sided z-test with continuity correction (pooled)||||||.271
71685039|NCT01900431|142888507|SUPERIORITY||Odds Ratio (OR)|2.1||||0.2354|TWO_SIDED|90.0|0.8|5.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using combined estimate for odds ratio obtained by combining the log-transformation of odds ratio from Cochran Mantel-Haenszel (CMH) analyses of the different imputed datasets, using Rubin's formulae, and then by back-transforming the combined estimate. The CMH analyses were adjusted for randomization stratification factor VH level (VH \>= 4 versus VH \<4).||5.6|0.8|0.2354
71685040|NCT01900431|142888508|SUPERIORITY||Least Square (LS) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.0127|TWO_SIDED|90.0|-1.223|-0.262||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using mixed effect model with repeated measures (MMRM) with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline adjudicated VH.||-0.262|-1.223|0.0127
71685041|NCT01900431|142888509|SUPERIORITY||Odds Ratio (OR)|0.95||||1|TWO_SIDED|90.0|0.11|6.093||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||6.093|0.11|1
71877501|NCT02101515|143273965|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45|||||TWO_SIDED|95.0|0.22|0.93||||||||0.93|0.22|
71877502|NCT02101515|143273967|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.41|||||TWO_SIDED|95.0|0.67|8.4||||||||8.40|0.67|
71877503|NCT02101515|143273968|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.41|1.45||||||||1.45|0.41|
71917949|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.89|1.07|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.07|0.89|
71685042|NCT01900431|142888510|SUPERIORITY||LS Mean Difference|5.8|STANDARD_ERROR_OF_MEAN|2.26||0.0153|TWO_SIDED|90.0|1.99|9.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.||9.67|1.99|0.0153
71685043|NCT01900431|142888511|SUPERIORITY||LS Mean Difference|-26.5|STANDARD_ERROR_OF_MEAN|14.2||0.0683|TWO_SIDED|90.0|-50.41|-2.68||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-2.68|-50.41|0.0683
71877504|NCT02101515|143273969|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.71|||||TWO_SIDED|95.0|1.3|5.62||||||||5.62|1.30|
71917950|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||TWO_SIDED|95.0|0.98|1.17|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.17|0.98|
71917951|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.||1.05|0.90|
71917952|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.13|0.80|
71917953|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.76|||||TWO_SIDED|95.0|0.65|0.9|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.90|0.65|
71917954|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.64|0.85|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.85|0.64|
71917955|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.59|||||TWO_SIDED|95.0|0.51|0.69|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.69|0.51|
71917956|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.71|||||TWO_SIDED|95.0|0.62|0.81|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||0.81|0.62|
71685044|NCT01900431|142888512|SUPERIORITY||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|3.55||0.0825|TWO_SIDED|90.0|-12.374|-0.35||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (\<4, \>=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).||-0.35|-12.374|0.0825
71877505|NCT02101515|143273970|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.06|13.92||||||||13.92|0.06|
71877506|NCT02101515|143273972|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|5.41|||||TWO_SIDED|95.0|0.68|42.9||||||||42.90|0.68|
71877507|NCT02101515|143273974|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8|||||TWO_SIDED|95.0|0.46|1.54||||||||1.54|0.46|
71877508|NCT02101515|143273975|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.39|1.49||||||||1.49|0.39|
71877509|NCT02101515|143273977|SUPERIORITY_OR_OTHER|||||||0.6|||||||t-test, 2 sided|||||||0.6
71917957|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.89|1.14|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.||1.14|0.89|
71917958|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||TWO_SIDED|95.0|0.88|1.21|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.21|0.88|
71917959|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.71|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.71|
71685045|NCT01900431|142888515|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|90.0|0.306|3.845||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH \>=4 versus VH \<4).||3.845|0.306|1
71877510|NCT02101515|143273981|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3|||||TWO_SIDED|95.0|0.03|2.77||||||||2.77|0.03|
71685046|NCT00603382|142888571|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.101||||0.095|TWO_SIDED|95.0|-0.018|0.221|||ANCOVA|||||0.221|-0.018|0.095
71685047|NCT00603382|142888571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129||||0.033|TWO_SIDED|95.0|0.011|0.247|||ANCOVA|||||0.247|0.011|0.033
71685048|NCT00603382|142888571|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.204|||<|0.001|TWO_SIDED|95.0|0.089|0.319|||ANCOVA|||||0.319|0.089|<0.001
71877511|NCT00698932|143273982|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.079|<|0.0001||95.0|-0.65|-0.34|||ANCOVA|\*adjusted for baseline HbA1c||||-0.34|-0.65|<0.0001
71685049|NCT00603382|142888571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|||<|0.001|TWO_SIDED|95.0|0.111|0.349|||ANCOVA|||||0.349|0.111|<0.001
71685050|NCT00603382|142888571|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106||||0.074|TWO_SIDED|95.0|-0.01|0.223|||ANCOVA|||||0.223|-0.010|0.074
71685051|NCT03782974|142888594|SUPERIORITY||Least Square Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.104|<|0.0001|TWO_SIDED|95.0|-0.77|-0.37||The threshold for statistical significance was p=0.05|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.37|-0.77|<0.0001
71685052|NCT03782974|142888595|SUPERIORITY||Risk Difference (RD)|0.27|||<|0.0001|TWO_SIDED|95.0|0.1|0.59||The threshold for statistical significance was p=0.05.|Chi-squared|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||0.59|0.10|<0.0001
71685053|NCT03782974|142888596|SUPERIORITY||Least Square Mean Difference|6.35|||<|0.001|TWO_SIDED|95.0|3.93|8.77||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||8.77|3.93|<0.001
71685054|NCT03782974|142888597|SUPERIORITY||Least Square Mean Difference|4.049|||<|0.05|TWO_SIDED|95.0|1.08|7.01||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||7.01|1.08|<0.05
71877512|NCT00698932|143273983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.06|-0.39|||ANCOVA|\*adjusted for baseline FPG||||-0.39|-1.06|<0.0001
71877513|NCT00698932|143273984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.12|STANDARD_ERROR_OF_MEAN|3.053|<|0.0001||95.0|-19.12|-7.13|||ANCOVA|\*adjusted for baseline FPG||||-7.13|-19.12|<0.0001
71877514|NCT00698932|143273985|SUPERIORITY_OR_OTHER||Median Difference (Net)|-182.0|STANDARD_ERROR_OF_MEAN|54.4||0.001||95.0|-289.0|-74.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-74|-289|0.001
71685055|NCT03782974|142888598|SUPERIORITY|||||||0.6||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||0.6
71877515|NCT00698932|143273986|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3280.0|STANDARD_ERROR_OF_MEAN|980.0||0.001||95.0|-5214.0|-1345.0|||ANCOVA|\*adjusted for baseline PPG AUC||||-1345|-5214|0.001
71877516|NCT00698932|143273987|SUPERIORITY_OR_OTHER||Median Difference (Net)|17.0|||<|0.0001||95.0|8.9|24.9|||ANCOVA|||||24.9|8.9|<0.0001
71877517|NCT02243865|143274080|SUPERIORITY|||||||0.6938|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||||||0.6938
71685056|NCT03782974|142888599|SUPERIORITY|||||||0.054||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.054
71685057|NCT03782974|142888600|SUPERIORITY|||||||0.13||||||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||||0.13
71685058|NCT03782974|142888601|SUPERIORITY||Least Square Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.102|<|0.0001|TWO_SIDED|95.0|-0.96|-0.56||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|||It was calculated that 138 participants randomized in a 1:1 ratio between the 2 arms would have a least 90% power to detect a difference of a big effect size between Proglucamune Treatment and Placebo from baseline to week 12.||-0.56|-0.96|<0.0001
71685059|NCT02993354|142888606|SUPERIORITY||Relative Rate|0.95||||0.75|TWO_SIDED|95.0|0.69|1.31|||t-test, 2 sided|||||1.31|0.69|0.75
71685060|NCT01783821|142888614|SUPERIORITY_OR_OTHER|||||||0.02|||||||Type 3 Wald Test|||Overall p-value of the day by treatment interaction from the random effects model using a type 3 Wald test.||||0.02
71685061|NCT01783821|142888615|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||Comparison between the two arms for the 3 categories.||||0.01
71685062|NCT01783821|142888616|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.01
71685063|NCT01783821|142888617|SUPERIORITY_OR_OTHER|||||||0.01|||||||Fisher Exact|||||||0.01
71685064|NCT01783821|142888618|SUPERIORITY_OR_OTHER|||||||0.02|||||||Cox Proportional Hazard, Fine/Gray adj.|||||||0.02
71685065|NCT01783821|142888619|SUPERIORITY_OR_OTHER|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71758581|NCT04922216|143019381|SUPERIORITY||Odds Ratio (OR)|1.01||||0.95|TWO_SIDED|95.0|0.72|1.42|||Chi-squared|DF (1)|Standard decision rules coded as 0 (reference) and adaptive decision rules coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between standard message decision rules and adaptive message decision rules (factor 4).||1.42|0.72|0.95
71877518|NCT02243865|143274081|SUPERIORITY|||||||0.6557|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 1st month of the three month post treatment investigation duration||||0.6557
71877519|NCT02243865|143274081|SUPERIORITY|||||||0.515|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 2nd month of the three month post treatment investigation duration||||0.515
71877520|NCT02243865|143274081|SUPERIORITY|||||||0.3256|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the 3rd month of the three month post treatment investigation duration||||0.3256
71877521|NCT02243865|143274081|SUPERIORITY|||||||0.4086|||||||ANCOVA|In the analyses the baseline value was used as a covariate in order to adjust for initial differences at treatment start.||Null hypothesis: There is no difference between the active treatment and placebo groups in change from baseline in number of migraine days during the final four weeks of the three month post treatment investigation duration.||||0.4086
71877522|NCT00053703|143274100|SUPERIORITY_OR_OTHER|||||||0.05|||||||Mixed Models Analysis|||||||0.05
71917960|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.84|||||TWO_SIDED|95.0|0.74|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.95|0.74|
71917961|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.59|0.76|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.76|0.59|
71917962|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.68|0.87|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||0.87|0.68|
71917963|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.92|1.14|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.||1.14|0.92|
71917964|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.27|||||TWO_SIDED|95.0|0.97|1.66|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.66|0.97|
71917965|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.16|||||TWO_SIDED|95.0|0.9|1.5|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.50|0.90|
71917966|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|1.06|1.61|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.61|1.06|
71917967|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.19|||||TWO_SIDED|95.0|0.96|1.48|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.48|0.96|
71917968|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.15|||||TWO_SIDED|95.0|0.93|1.42|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.42|0.93|
71917969|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||TWO_SIDED|95.0|0.79|1.16|||||Comparison for Day 7, triglycerides|An estimation approach was used.||1.16|0.79|
71917970|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|0.86|1.17|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.17|0.86|
71877523|NCT01500525|143274106|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0|||<|0.05|ONE_SIDED|95.0|||||Regression, Cox|||||||<0.05
71877524|NCT04166383|143274108|OTHER|||||||0.1||||||P≤0.10 (alpha 0.1); power = 90% (beta 0.1)|Kaplan-Meier|||||||0.10
71877525|NCT03044886|143274115|SUPERIORITY|||||||0.576|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.576
71877526|NCT03044886|143274116|SUPERIORITY|||||||0.489|||||||ANOVA|||||||0.489
71877527|NCT03044886|143274117|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
71917971|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||TWO_SIDED|95.0|0.73|0.96|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.96|0.73|
71917972|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.73|0.91|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.91|0.73|
71917973|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.66|0.82|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.82|0.66|
71917974|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.69|0.86|||||Comparison for Day 14, cholesterol|An estimation approach was used.||0.86|0.69|
71917975|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||Comparison for Day 14, cholesterol|An estimation approach was used.||1.03|0.84|
71917976|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.09|||||TWO_SIDED|95.0|0.99|1.21|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.21|0.99|
71877528|NCT03044886|143274117|SUPERIORITY|||||||0.041|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.041
71877529|NCT03044886|143274118|SUPERIORITY|||||||0.71|||||||ANCOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.710
71877530|NCT03044886|143274119|SUPERIORITY|||||||0.34|||||||ANOVA|||||||0.340
71877531|NCT03044886|143274120|SUPERIORITY|||||||0.048|||||||ANOVA|||||||0.048
71877532|NCT03044886|143274120|SUPERIORITY|||||||0.038|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.038
71877533|NCT03044886|143274121|SUPERIORITY|||||||0.521|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.521
71877534|NCT03044886|143274122|SUPERIORITY|||||||0.742|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.742
71877535|NCT03044886|143274123|SUPERIORITY||||||<|0.05|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||<0.05
71877536|NCT03044886|143274123|SUPERIORITY|||||||0.073|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.073
71877537|NCT03044886|143274124|SUPERIORITY|||||||0.348|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.348
71877538|NCT03044886|143274125|SUPERIORITY|||||||0.685|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.685
71877539|NCT03044886|143274126|SUPERIORITY|||||||0.075|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.||||0.075
71877540|NCT03044886|143274126|SUPERIORITY|||||||0.083|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.||||0.083
71877541|NCT00074581|143274175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.07|||<|0.0001|TWO_SIDED|95.0|0.02|0.22|||Regression, Cox||The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.|||0.22|0.02|<0.0001
71877542|NCT00074581|143274176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.19|0.53|||Regression, Cox||The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.|||0.53|0.19|<0.0001
71877543|NCT00617604|143274228|SUPERIORITY_OR_OTHER||Difference|3.9|||||TWO_SIDED|90.0|-2.5|10.3||||||||10.3|-2.5|
71877544|NCT00617604|143274229|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-3.1|5.0||||||||5.0|-3.1|
71877545|NCT00617604|143274230|SUPERIORITY_OR_OTHER||Difference|3.0|||||TWO_SIDED|90.0|-4.0|10.1||||||||10.1|-4.0|
71877546|NCT00617604|143274231|SUPERIORITY_OR_OTHER||Difference|1.0|||||TWO_SIDED|90.0|-0.6|2.5||||||||2.5|-0.6|
71877547|NCT00617604|143274232|SUPERIORITY_OR_OTHER||Difference|-5.1|||||TWO_SIDED|90.0|-14.9|4.7||||||||4.7|-14.9|
71877548|NCT00617604|143274233|SUPERIORITY_OR_OTHER||Difference|-9.4|||||TWO_SIDED|90.0|-18.5|0.0||||||||0.0|-18.5|
71877549|NCT00617604|143274234|SUPERIORITY_OR_OTHER||Difference|-1.9|||||TWO_SIDED|90.0|-7.6|3.8||||||||3.8|-7.6|
71877550|NCT00617604|143274235|SUPERIORITY_OR_OTHER||Difference|-1.8|||||TWO_SIDED|90.0|-8.2|4.6||||||||4.6|-8.2|
71877551|NCT00617604|143274236|SUPERIORITY_OR_OTHER||Difference|1.9|||||TWO_SIDED|90.0|-1.3|5.0||||||||5.0|-1.3|
71877552|NCT00617604|143274237|SUPERIORITY_OR_OTHER||Difference|4.6|||||TWO_SIDED|90.0|-1.2|10.4||||||||10.4|-1.2|
71877553|NCT00617604|143274239|SUPERIORITY_OR_OTHER||Difference|2.0|||||TWO_SIDED|90.0|-3.3|7.2||||||||7.2|-3.3|
71877554|NCT00617604|143274244|SUPERIORITY_OR_OTHER||Slope|6.0|||||TWO_SIDED|90.0|-2.7|14.6||||||||14.6|-2.7|
71877555|NCT00617604|143274245|SUPERIORITY_OR_OTHER||Difference|-4.5|||||TWO_SIDED|90.0|-11.2|2.2||||||||2.2|-11.2|
71877556|NCT00617604|143274246|SUPERIORITY_OR_OTHER||Difference|5.2|||||TWO_SIDED|90.0|-4.4|14.7||||||||14.7|-4.4|
71877557|NCT02303704|143274248|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||P-value less than 0.05 was considered significant|t-test, 2 sided|two compare two independent quantitative groups||Null hypothesis was there is no significant difference between the means of two groups||||<0.05
71877558|NCT02303704|143274249|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71877559|NCT02303704|143274250|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to check the equality of means|||||<|0.05|TWO_SIDED|||||p-value \<0.05 was considered significant.|t-test, 2 sided|To compare the means between the two groups, to find out the significant difference between Group I and II.||Null Hypothesis: The dose of nor-adrenaline on weaning from CPB is same for Group I and II.||||<0.05
71877560|NCT02303704|143274251|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|to chek the equality of means between the two groups|||||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71877561|NCT02303704|143274252|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||p- value less than 0.05 was considered as significant difference in proportion between the two groups|Chi-squared|two compare the qualitative data between two groups||Null Hypothesis:The proportion of IABP use is same between the two groups||||<0.05
71877562|NCT02303704|143274253|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|TWO_SIDED|||||P-value \<0.05 was considered to be significant i.e. operative mortality is not same between the two groups|Fisher Exact|Fisher exact test was used because 1 cell (25%) have expected count less than 5.||Null Hypothesis: Operative mortality ratio is same in both groups||||<0.05
71877563|NCT00705432|143274269|SUPERIORITY_OR_OTHER||The difference in SVR|26.6|||<|0.0001|TWO_SIDED|95.0|19.1|34.1|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||34.1|19.1|<0.0001
71877564|NCT00705432|143274269|SUPERIORITY_OR_OTHER||The difference in SVR|28.3|||<|0.0001|TWO_SIDED|95.0|20.8|35.8|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.8|20.8|<0.0001
71877565|NCT00705432|143274269|SUPERIORITY_OR_OTHER||The difference in SVR|19.2||||0.044|TWO_SIDED|95.0|1.6|36.9|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.9|1.6|0.0440
71877566|NCT00705432|143274269|SUPERIORITY_OR_OTHER||The difference in SVR|29.7||||0.0035|TWO_SIDED|95.0|12.2|47.1|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||47.1|12.2|0.0035
71877567|NCT00705432|143274270|SUPERIORITY_OR_OTHER||The difference in SVR rates|27.5|||<|0.0001|TWO_SIDED|95.0|19.2|35.2|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||35.2|19.2|<0.0001
71877568|NCT00705432|143274270|SUPERIORITY_OR_OTHER||The difference in SVR rates|29.1|||<|0.0001|TWO_SIDED|95.0|21.5|36.8|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||36.8|21.5|<0.0001
71877569|NCT00705432|143274270|SUPERIORITY_OR_OTHER||The difference in SVR|21.3||||0.0366|TWO_SIDED|95.0|2.3|40.2|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||40.2|2.3|0.0366
71877570|NCT00705432|143274270|SUPERIORITY_OR_OTHER||The difference in SVR|27.2||||0.0107|TWO_SIDED|95.0|9.0|45.3|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).||||45.3|9.0|0.0107
71877571|NCT01034540|143274287|SUPERIORITY_OR_OTHER_LEGACY|||||||0.959||||||Values were not normally distributed, thus analyses were performed on ranked values and medians (IQL) are presented.|ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||An evaluable sample of 19 subjects provided 80% power (5% alpha-level, 2-tailed) to detect a 2.1 unit difference between control and active in MISI, assuming a 3.0 unit standard deviation (SD). Repeated measures ANOVA was used to assess responses to treatment. Initial repeated measures models contained terms of treatment period, and sequence as fixed effects, with subject modeled as random effect; models were reduced until only significant terms or treatment remained.||||0.959
71877572|NCT01034540|143274288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||ANOVA|All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).||||||0.037
71877573|NCT01034540|143274288|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073||||||All tests of statistical significance were completed at the 5% level, two-tailed (p\<0.05).|ANOVA|||||||0.073
71877574|NCT02347488|143274293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|1.8|<|0.001|TWO_SIDED|95.0|2.88|3.32|||ANCOVA|||Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures.||3.32|2.88|<0.001
71877575|NCT01641237|143274347|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||<0.0001
71877576|NCT01641237|143274347|SUPERIORITY_OR_OTHER|||||||0.3748||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.||||0.3748
71877577|NCT01641237|143274348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.17||||0.1898|TWO_SIDED|95.0|-1.09|5.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||5.43|-1.09|0.1898
71877578|NCT01641237|143274348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.6||||0.0009|TWO_SIDED|95.0|2.35|8.86||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.||8.86|2.35|0.0009
71877579|NCT01641237|143274348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.43||||0.0389|TWO_SIDED|95.0|0.18|6.68||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||6.68|0.18|0.0389
71877580|NCT01641237|143274348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.86|||<|0.0001|TWO_SIDED|95.0|6.58|13.13||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||13.13|6.58|<0.0001
71877581|NCT01641237|143274348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.68|||<|0.0001|TWO_SIDED|95.0|4.41|10.96||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||10.96|4.41|<0.0001
71877582|NCT01641237|143274348|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.25||||0.0112|TWO_SIDED|95.0|0.98|7.53||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.||7.53|0.98|0.0112
71877583|NCT01641237|143274349|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.||||<0.0001
71877584|NCT01641237|143274349|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANOVA|||Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.||||0.0002
71877585|NCT01641237|143274349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|32.38|||<|0.0001|TWO_SIDED|95.0|25.18|39.59||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||39.59|25.18|<0.0001
71877586|NCT01641237|143274349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|31.46|||<|0.0001|TWO_SIDED|95.0|24.25|38.67||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||38.67|24.25|<0.0001
71877587|NCT01641237|143274349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|20.81|||<|0.0001|TWO_SIDED|95.0|13.6|28.02||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||28.02|13.60|<0.0001
71877588|NCT01641237|143274349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.92||||0.8|TWO_SIDED|95.0|-6.25|8.1||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||8.10|-6.25|0.8000
71877589|NCT01641237|143274349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.57||||0.0017|TWO_SIDED|95.0|4.4|18.74||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||18.74|4.40|0.0017
71877590|NCT01641237|143274349|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.65||||0.0038|TWO_SIDED|95.0|3.48|17.81||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||17.81|3.48|0.0038
71877591|NCT01641237|143274350|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.||||<0.0001
71877592|NCT01641237|143274350|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.||||0.0008
71877593|NCT01641237|143274350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.66|||<|0.0001|TWO_SIDED|95.0|1.42|1.9||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.90|1.42|<0.0001
71877594|NCT01641237|143274350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.6|||<|0.0001|TWO_SIDED|95.0|1.36|1.85||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.85|1.36|<0.0001
71877595|NCT01641237|143274350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.62|||<|0.0001|TWO_SIDED|95.0|0.38|0.86||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.86|0.38|<0.0001
71877596|NCT01641237|143274350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.05||||0.668|TWO_SIDED|95.0|-0.19|0.29||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||0.29|-0.19|0.6680
71877597|NCT01641237|143274350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.04|||<|0.0001|TWO_SIDED|95.0|0.8|1.28||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.28|0.80|<0.0001
71685066|NCT01907217|142888631|NON_INFERIORITY_OR_EQUIVALENCE|"The prespecified noninferiority margin was no more than a -4 point difference at the end of treatment between the bilateral and unilateral groups.~The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\] = -1.67 to 3.84."|Mean Difference (Final Values)|1.08|||<|0.05|TWO_SIDED|95.0|-1.67|3.84||Primary statistical analysis was assessment of difference in HAM-D scores between arms at end-of-treatment, supplemented by 95% CIs and this interval compared with the pre-specified noninferiority threshold (-4 points). The p-value was calculated.|Regression, Linear|A regression model was fitted to end-of-treatment HAM-D measures, with baseline HAM-D scores, trial arm, randomization stratifiers as covariates.|The prespecified noninferiority margin was no more than a -4-point difference at the end of treatment between bitemporal and unilateral groups. The predicted difference at the end of treatment was 1.08 (95% confidence interval \[CI\]=-1.67 to 3.84).|Based on a large bitemporal ECT series, we estimated that 69 patients were required per group to have 80% power to demonstrate, using a one-sided equivalence t test at 5% level, that the mean reduction in the 24-item HAM-D score following high-dose unilateral ECT was no more than 4 points (i.e., equivalent to 3 points on the 17-item HAM-D, deemed to be clinically relevant \[30\]) less than that achieved using bitemporal ECT.||3.84|-1.67|<0.05
71917977|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||TWO_SIDED|95.0|0.93|1.11|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.11|0.93|
71917978|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.9|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.90|
71917979|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.06|0.92|
71917980|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||TWO_SIDED|95.0|0.94|1.08|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.08|0.94|
71917981|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.92|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.||1.04|0.92|
71917982|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.85|||||TWO_SIDED|95.0|0.69|1.04|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.04|0.69|
71917983|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.58|0.85|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.85|0.58|
71917984|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.62|0.86|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.86|0.62|
71917985|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.6|||||TWO_SIDED|95.0|0.5|0.71|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.71|0.50|
71917986|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.59|0.8|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||0.80|0.59|
71917987|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.94|||||TWO_SIDED|95.0|0.81|1.09|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.||1.09|0.81|
71917988|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.8|1.22|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.22|0.80|
71917989|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.64|0.93|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.93|0.64|
71917990|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.67|0.9|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.90|0.67|
71917991|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.65|||||TWO_SIDED|95.0|0.55|0.75|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.75|0.55|
71917992|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.6|0.81|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||0.81|0.60|
71917993|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.8|1.04|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.||1.04|0.80|
71685067|NCT01907217|142888632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.001|TWO_SIDED|95.0|0.51|0.85||As above|generalized linear models with a binomia|||"The AMI-SF at end of treatment was analyzed using generalized linear models with a binomial distribution and logit-link. Post treatment AMI-SF measures provide the number of baseline items recalled after ECT; such number of items recalled variables were therefore modeled as arising from binomial distributions, with maximum number of possible recalls set to the number of items obtained at baseline."||0.85|0.51|0.001
71685068|NCT01907217|142888633|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.78|||Regression, Linear|Analyzed using a generalized linear models with a binomial distribution and logit-link.||||0.78|0.45|0.001
71685069|NCT01907217|142888634|SUPERIORITY||Odds Ratio (OR)|0.59||||0.001|TWO_SIDED|95.0|0.45|0.79|||Regression, Linear|generalized linear models with a binomial distribution and logit-link||||0.79|0.45|0.001
71877598|NCT01641237|143274350|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.99|||<|0.0001|TWO_SIDED|95.0|0.75|1.23||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.||1.23|0.75|<0.0001
71877599|NCT05368961|143274390|OTHER|Null hypothesis; there is no difference in anxiety scores between usual care and distraction||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71877600|NCT03593850|143274396|SUPERIORITY|||||||0.002|||||||t-test, 2 sided|||||||0.002
71877601|NCT03593850|143274397|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.392|||||||t-test, 2 sided|||||||0.392
71917994|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.42|||||TWO_SIDED|95.0|1.01|2.0|||||Comparison for Day 14, triglycerides|An estimation approach was used.||2.00|1.01|
71917995|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.28|||||TWO_SIDED|95.0|0.94|1.75|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.75|0.94|
71917996|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.24|||||TWO_SIDED|95.0|0.98|1.58|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.58|0.98|
71877602|NCT03593850|143274398|EQUIVALENCE|Equivalence analysis was performed according to pre-defined significant difference of p \< 0.01||||||0.802|||||||t-test, 2 sided|||||||0.802
71877603|NCT03593850|143274399|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71877604|NCT03593850|143274399|SUPERIORITY||Adjusted mean difference|1.429||||0.006|TWO_SIDED||||||ANCOVA|Fixed factors: group, covariates: pain before (VAS2), age in years, age at menarche, duration of menses, usual pain, anxiety before, hours with pain.|||Adjusted means: music 3.131 (99% CI 2.62, 3.999) and silence 4.56 (99% CI 3.581, 5.538), F= 8.44, R-square 54.5%|||0.006
71877605|NCT03593850|143274400|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71685070|NCT03704948|142888637|SUPERIORITY||Mean Difference (Net)|0.82|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71685071|NCT01180049|142888648|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.731|||||TWO_SIDED|80.0|0.52|1.027||||||||1.027|0.520|
71685072|NCT01180049|142888649|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778|||||TWO_SIDED|80.0|0.568|1.064||||||||1.064|0.568|
71685073|NCT01180049|142888650|SUPERIORITY_OR_OTHER||Difference in arms|6.7|||||TWO_SIDED|80.0|-6.9|20.3||||||Independent assessment- Difference (%) TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||20.3|-6.9|
71685074|NCT01180049|142888651|SUPERIORITY_OR_OTHER||Difference between arms|13.3|||||TWO_SIDED|80.0|-0.4|26.7||||||Investigator's assessment- Difference (%)TEMSR 175/75 mg - TEMSR 75 mg (80% CI)||26.7|-0.4|
71685075|NCT01180049|142888652|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.646|||||TWO_SIDED|80.0|0.453|0.922||||||||0.922|0.453|
71758582|NCT04922216|143019381|SUPERIORITY||Odds Ratio (OR)|1.2||||0.29|TWO_SIDED|95.0|0.85|1.69|||Chi-squared|DF (1)|No message choice coded as 0 (reference) and message choice coded as 1; an odds ratio \> 1 indicates that the odds of achieving 5% weight loss are higher in the group coded as 1.|Chi-square test of the difference in proportion reaching 5% weight loss from baseline to 6 months between no message choice and message choice (factor 5).||1.69|0.85|0.29
71877606|NCT03593850|143274400|SUPERIORITY||Adjusted mean difference|0.721||||0.37|TWO_SIDED||||||ANCOVA|Fixed factor: Groups Covariates: Pain before, pain after, age, age menarche, menses duration, usual pain, anxiety before, anxiety after, hours pain|Adjusted means: music 2.58 (99% CI 1.339, 3.829), and silence 3.305 (1.728, 4.881); F 0.827, R-square 27.2%|||||0.370
71877607|NCT03593850|143274401|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.377|||||||t-test, 2 sided|||||||0.377
71877608|NCT03593850|143274402|SUPERIORITY|||||||0.049|||||||t-test, 2 sided|||||||0.049
71877609|NCT03593850|143274403|SUPERIORITY|||||||0.168|||||||t-test, 2 sided|||||||0.168
71877610|NCT03593850|143274404|EQUIVALENCE|Equivalence between groups was pre-defined as p \> 0.01||||||0.642|||||||Chi-squared|||||||0.642
71877611|NCT03593850|143274405|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
71877612|NCT03593850|143274406|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71877613|NCT03593850|143274407|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.307|||||||t-test, 2 sided|||||||0.307
71877614|NCT03593850|143274408|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.318|||||||t-test, 2 sided|||||||0.318
71877615|NCT03593850|143274409|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.954|||||||t-test, 2 sided|||||||0.954
71877616|NCT03593850|143274410|EQUIVALENCE|Equivalence between groups determined by pre-deined p \> 0.01||||||0.258|||||||t-test, 2 sided|||||||0.258
71877617|NCT03593850|143274411|SUPERIORITY|||||||0.058|||||||t-test, 2 sided|||||||0.058
71877618|NCT03593850|143274412|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||||||0.056
71877619|NCT03593850|143274413|SUPERIORITY|||||||0.885|||||||t-test, 2 sided|||||||0.885
71877620|NCT03593850|143274414|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
71877621|NCT01735279|143274418|OTHER|Test t Student|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED||||||ANOVA|||||||<0.05
71917997|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.22|||||TWO_SIDED|95.0|0.95|1.56|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.56|0.95|
71917998|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.23|||||TWO_SIDED|95.0|0.96|1.57|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.57|0.96|
71917999|NCT02202161|143357916|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.72|1.11|||||Comparison for Day 14, triglycerides|An estimation approach was used.||1.11|0.72|
71918000|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||TWO_SIDED|95.0|0.87|1.11|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.11|0.87|
71918001|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.79|||||TWO_SIDED|95.0|0.71|0.89|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.89|0.71|
71918002|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||TWO_SIDED|95.0|0.74|0.9|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.90|0.74|
71918003|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|0.63|0.77|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.77|0.63|
71877622|NCT01735279|143274418|SUPERIORITY||Mean Difference (Final Values)|30.84|||<|0.01|ONE_SIDED|95.0|||||ANOVA|||||||<0.01
71877623|NCT01735279|143274418|SUPERIORITY||Mean Difference (Final Values)|0.002|||<|0.01|TWO_SIDED||||||t-test, 1 sided|||||||<0.01
71877624|NCT01735279|143274418|SUPERIORITY||Mean Difference (Final Values)|4.4|||<|0.01|ONE_SIDED||||||t-test, 1 sided|||||||<0.01
71877625|NCT00119041|143274419|SUPERIORITY_OR_OTHER||||||>|0.153|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|||Comparisons were made between the intervention and control groups at baseline||||>0.153
71877626|NCT00119041|143274419|SUPERIORITY_OR_OTHER||||||>|0.25|TWO_SIDED|||||Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|Threshold for statistical significance was p\<0.025 using Bonferroni correction for 2 statistical tests.||Comparisons were made between the intervention and control groups at 18 months||||>0.25
71877627|NCT01195090|143274437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.165|TWO_SIDED|95.0|-0.58|0.08||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.|ANCOVA|||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor 'treatment' and baseline A1C as covariate.||0.08|-0.58|0.165
71877628|NCT01195090|143274453|NON_INFERIORITY_OR_EQUIVALENCE|Chi-square test|Chi-Square|0.0034||||0.954||||||Chi-square test|Chi-squared|||Chi-square test for percentages of patient achieving an A1C \<7%||||0.954
71877629|NCT05111041|143274466|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.302|3.309||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.309|0.302|1.000
71877630|NCT05111041|143274467|SUPERIORITY||Odds Ratio (OR)|0.8||||0.7389|TWO_SIDED|95.0|0.215|2.972||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||2.972|0.215|0.7389
71877631|NCT05111041|143274469|SUPERIORITY||Odds Ratio (OR)|1.306||||0.6058|TWO_SIDED|95.0|0.474|3.602||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.602|0.474|0.6058
71877632|NCT05111041|143274470|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.349|2.866||||||||2.866|0.349|
71877633|NCT05111041|143274471|SUPERIORITY||Odds Ratio (OR)|1.333||||0.5925|TWO_SIDED|95.0|0.465|3.823||Not adjusted for multiple outcomes due to exploratory nature of the study.|Regression, Logistic|||||3.823|0.465|0.5925
71877634|NCT01205230|143274472|SUPERIORITY_OR_OTHER||Ratio of least square geometric means|1.66|||||TWO_SIDED|90.0|1.39|1.99|||||Ratio of least square (LS) geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.99|1.39|
71877635|NCT01205230|143274472|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.6|||||TWO_SIDED|90.0|0.52|0.7|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.70|0.52|
71877636|NCT01205230|143274473|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|1.45|||||TWO_SIDED|90.0|1.14|1.86|||||Ratio of LS geometric means (Pazopanib + Ketoconozole : Pazopanib alone)|||1.86|1.14|
71877637|NCT01205230|143274473|SUPERIORITY_OR_OTHER||Ratio of LS geometric means|0.58|||||TWO_SIDED|90.0|0.5|0.67|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)|||0.67|0.50|
71877638|NCT01205230|143274474|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.45|||||TWO_SIDED|90.0|-1.06|0.06||||||||0.06|-1.06|
71877639|NCT01205230|143274474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.07|||||TWO_SIDED|90.0|-0.1|2.44||||||||2.44|-0.10|
71877640|NCT00791258|143274482|SUPERIORITY_OR_OTHER||Percentage|75.8|||||TWO_SIDED|95.0|73.0|78.5||||||||78.5|73.0|
71877641|NCT00791258|143274483|SUPERIORITY_OR_OTHER||Percentage|84.3|||||TWO_SIDED|95.0|81.8|86.5||||||||86.5|81.8|
71877642|NCT00791258|143274484|SUPERIORITY_OR_OTHER||Percentage|71.3|||||TWO_SIDED|95.0|68.3|74.1||||||12 week analysis||74.1|68.3|
71877643|NCT00791258|143274484|SUPERIORITY_OR_OTHER||Percentage|84.8|||||TWO_SIDED|95.0|82.4|87.0||||||20 week analysis||87.0|82.4|
71918004|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||TWO_SIDED|95.0|0.7|0.85|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||0.85|0.70|
71918005|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||TWO_SIDED|95.0|0.89|1.06|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.||1.06|0.89|
71918006|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.07|0.77|
71918007|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.81|||||TWO_SIDED|95.0|0.68|0.95|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.95|0.68|
71918008|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.8|||||TWO_SIDED|95.0|0.7|0.91|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.91|0.70|
71918009|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||TWO_SIDED|95.0|0.58|0.77|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.77|0.58|
71918010|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||TWO_SIDED|95.0|0.64|0.83|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||0.83|0.64|
71918011|NCT02202161|143357917|SUPERIORITY_OR_OTHER|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.8|1.02|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.||1.02|0.80|
71918012|NCT01930487|143357928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.037|STANDARD_ERROR_OF_MEAN|0.011||0.0016|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0016
71918013|NCT01930487|143357929|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025|STANDARD_ERROR_OF_MEAN|0.011||0.0249|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0249
71918014|NCT01930487|143357930|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.3||0.9147|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9147
71918015|NCT01930487|143357931|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.67|STANDARD_ERROR_OF_MEAN|0.59||0.007|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0070
71918016|NCT01930487|143357932|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.97|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED||||||paired t-test, 2-sidede||dietary supplement with antioxidants - placebo|||||<0.0001
71918017|NCT01930487|143357933|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.23||0.0476|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0476
71918018|NCT01930487|143357934|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|STANDARD_ERROR_OF_MEAN|0.21||0.0352|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0352
71918019|NCT01930487|143357935|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.21||0.0208|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0208
71918020|NCT01930487|143357936|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
71918021|NCT01930487|143357937|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|0.07||0.0024|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0024
71918022|NCT01930487|143357938|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21|STANDARD_ERROR_OF_MEAN|0.07||0.0081|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0081
71918023|NCT01930487|143357939|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002|STANDARD_ERROR_OF_MEAN|0.008||0.8191|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8191
71918024|NCT01930487|143357940|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.018|STANDARD_ERROR_OF_MEAN|0.009||0.0482|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0482
71918025|NCT01930487|143357941|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.019|STANDARD_ERROR_OF_MEAN|0.023||0.023|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0230
71918026|NCT01930487|143357942|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.013|STANDARD_ERROR_OF_MEAN|0.008||0.1202|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1202
71918027|NCT01930487|143357943|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.55|STANDARD_ERROR_OF_MEAN|0.83||0.0063|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0063
71918028|NCT01930487|143357944|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.8||0.3347|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3347
71918029|NCT01930487|143357945|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.35||0.0094|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0094
71918030|NCT01930487|143357946|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.92|STANDARD_ERROR_OF_MEAN|0.24||0.0009|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0009
71918031|NCT01930487|143357947|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02|STANDARD_ERROR_OF_MEAN|0.34||0.0067|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0067
71918032|NCT01930487|143357948|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.25||0.6938|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6938
71758583|NCT00753506|143019441|SUPERIORITY_OR_OTHER||F|1.59|||>|0.1|TWO_SIDED|95.0|||||ANOVA|||Repeated measures analaysis of variance||||>0.10
71877644|NCT00791258|143274485|SUPERIORITY_OR_OTHER||Median Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.4|-13.8|||t-test, 1 sided|||4 week analysis||-13.8|-15.4|<0.0001
71877645|NCT00791258|143274485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.6|||<|0.0001|TWO_SIDED|95.0|-17.7|-15.7|||t-test, 1 sided|||8 week analysis||-15.7|-17.7|<0.0001
71918033|NCT01930487|143357949|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56|STANDARD_ERROR_OF_MEAN|0.3||0.0805|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0805
71918034|NCT01930487|143357950|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.29||0.2451|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2451
71918035|NCT01930487|143357951|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78|STANDARD_ERROR_OF_MEAN|0.34||0.0323|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0323
71918036|NCT01930487|143357952|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.26||0.344|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3440
71918037|NCT01930487|143357953|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.13||0.0119|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0119
71918038|NCT01930487|143357954|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||<0.0001
71918039|NCT01930487|143357955|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.32|STANDARD_ERROR_OF_MEAN|0.12||0.0137|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0137
71918040|NCT01930487|143357956|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.09||0.0866|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0866
71918041|NCT01930487|143357957|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|STANDARD_ERROR_OF_MEAN|0.12||0.0656|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0656
71918042|NCT01930487|143357958|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.09||0.0626|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0626
71918043|NCT01930487|143357959|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003|STANDARD_ERROR_OF_MEAN|0.013||0.81|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.8100
71918044|NCT01930487|143357960|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.001|STANDARD_ERROR_OF_MEAN|0.01||0.9556|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.9556
71918045|NCT01930487|143357961|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.015|STANDARD_ERROR_OF_MEAN|0.015||0.3414|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3414
71918046|NCT01930487|143357962|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021|STANDARD_ERROR_OF_MEAN|0.009||0.033|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0330
71918047|NCT01930487|143357963|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3326|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3326
71918048|NCT01930487|143357964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.027|STANDARD_ERROR_OF_MEAN|0.012||0.0348|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0348
71918049|NCT01930487|143357965|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.016|STANDARD_ERROR_OF_MEAN|0.012||0.2089|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.2089
71918050|NCT01930487|143357966|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.012||0.3738|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.3738
71918051|NCT01930487|143357967|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|1.7||0.447|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.4470
71918052|NCT01930487|143357968|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|2.1||0.6382|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.6382
71918053|NCT01930487|143357969|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.043|STANDARD_ERROR_OF_MEAN|0.012||0.0026|TWO_SIDED||||||paird t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0026
71918054|NCT01930487|143357970|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.018||0.1045|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.1045
71918055|NCT01930487|143357971|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.013||0.6941|TWO_SIDED||||||paired t-test||dietary supplement with antioxidants - placebo|||||0.6941
71918056|NCT01930487|143357972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.017||0.0138|TWO_SIDED||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo|||||0.0138
71918057|NCT02711553|143357973|SUPERIORITY||Hazard Ratio (HR)|1.123||||0.4821|TWO_SIDED|80.0|0.904|1.395||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.395|0.904|0.4821
71918058|NCT02711553|143357973|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.6417|TWO_SIDED|80.0|0.734|1.153||p-value is 2-sided.|Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.153|0.734|0.6417
71918059|NCT02711553|143357974|SUPERIORITY||Hazard Ratio (HR)|1.336||||0.087|TWO_SIDED|95.0|0.959|1.862|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.862|0.959|0.0870
71918060|NCT02711553|143357974|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7599|TWO_SIDED|95.0|0.669|1.342|||Log Rank|Stratified by geographical region, pathological diagnosis, metastatic disease.|Stratified by geographical region, pathological diagnosis, metastatic disease.|||1.342|0.669|0.7599
71877646|NCT00791258|143274485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.8|||<|0.0001|TWO_SIDED|95.0|-22.7|-20.9|||t-test, 1 sided|||12 week analysis||-20.9|-22.7|<0.0001
71877647|NCT00791258|143274485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.0|||<|0.0001|TWO_SIDED|95.0|-27.0|-25.0|||t-test, 1 sided|||16 week analysis||-25.0|-27.0|<0.0001
71877648|NCT00791258|143274485|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.8|||<|0.0001|TWO_SIDED|95.0|-27.8|-25.7|||t-test, 1 sided|||20 week analysis||-25.7|-27.8|<0.0001
71877649|NCT00791258|143274486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.1|||<|0.0001|TWO_SIDED|95.0|-8.6|-7.6|||t-test, 1 sided|||4 week analysis||-7.6|-8.6|<0.0001
71877650|NCT00791258|143274486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.1|||<|0.0001|TWO_SIDED|95.0|-9.7|-8.5|||t-test, 1 sided|||8 week analysis||-8.5|-9.7|<0.0001
71877651|NCT00791258|143274486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-11.4|||t-test, 1 sided|||12 week analysis||-11.4|-12.5|<0.0001
71918061|NCT02711553|143357975|SUPERIORITY||Odds Ratio (OR)|1.0||||0.878|TWO_SIDED|95.0|0.6|1.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||1.9|0.6|0.878
71877652|NCT00791258|143274486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.6|||<|0.0001|TWO_SIDED|95.0|-15.2|-14.0|||t-test, 1 sided|||16 week analysis||-14.0|-15.2|<0.0001
71877653|NCT00791258|143274486|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.5||||0.0001|TWO_SIDED|95.0|-15.1|-13.8|||t-test, 1 sided|||20 week analysis||-13.8|-15.1|0.0001
71877654|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.8|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.4|||t-test, 1 sided|||Mean 24-hour systolic blood pressure||-13.4|-16.2|<0.0001
71877655|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.3|||<|0.0001|TWO_SIDED|95.0|-17.8|-14.8|||t-test, 1 sided|||Mean daytime systolic blood pressure||-14.8|-17.8|<0.0001
71877656|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.5|||<|0.0001|TWO_SIDED|95.0|-14.1|-10.8|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-10.8|-14.1|<0.0001
71877657|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.6|||<|0.0001|TWO_SIDED|95.0|-15.7|-11.6|||t-test, 1 sided|||systolic blood pressure during last 2 hours of dose||-11.6|-15.7|<0.0001
71877658|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.0|||<|0.0001|TWO_SIDED|95.0|-14.7|-11.2|||t-test, 1 sided|||systolic blood pressure during last 4 hours of dose||-11.2|-14.7|<0.0001
71877659|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.6|||<|0.0001|TWO_SIDED|95.0|-14.3|-10.9|||t-test, 1 sided|||systolic blood pressure during last 6 hours of dose||-10.9|-14.3|<0.0001
71877660|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.4|||<|0.0001||95.0|-10.3|-8.5|||t-test, 1 sided|||Mean 24-hour diastolic blood pressure||-8.5|-10.3|<0.0001
71877661|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.6|||<|0.0001|TWO_SIDED|95.0|-11.7|-9.6|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-9.6|-11.7|<0.0001
71877662|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.6|||<|0.0001|TWO_SIDED|95.0|-8.8|-6.4|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-6.4|-8.8|<0.0001
71877663|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|||<|0.0001||95.0|-10.0|-7.2|||t-test, 1 sided|||diastolic blood pressure during last 2 hours of dose||-7.2|-10.0|<0.0001
71877664|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.2|-6.8|||t-test, 1 sided|||diastolic blood pressure during last 4 hours of dose||-6.8|-9.2|<0.0001
71877665|NCT00791258|143274498|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.7|||<|0.0001||95.0|-8.8|-6.6|||t-test, 1 sided|||diastolic blood pressure during last 6 hours of dose||-6.6|-8.8|<0.0001
71877666|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-21.0|||<|0.0001|TWO_SIDED|95.0|-22.6|-19.3|||t-test, 1 sided|||24-hour mean systolic blood pressure||-19.3|-22.6|<0.0001
71877667|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.2|||<|0.0001|TWO_SIDED|95.0|-25.1|-21.4|||t-test, 1 sided|||Mean daytime systolic blood pressure||-21.4|-25.1|<0.0001
71877668|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.5|||<|0.0001|TWO_SIDED|95.0|-19.4|-15.6|||t-test, 1 sided|||Mean nighttime systolic blood pressure||-15.6|-19.4|<0.0001
71877669|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.6|||<|0.0001|TWO_SIDED|95.0|-21.7|-17.4|||t-test, 1 sided|||Systolic blood pressure - last 2 hours of dose||-17.4|-21.7|<0.0001
71877670|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-18.2|||<|0.0001|TWO_SIDED|95.0|-20.2|-16.3|||t-test, 1 sided|||Systolic blood pressure - last 4 hours of dose||-16.3|-20.2|<0.0001
71877671|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.9|||<|0.0001|TWO_SIDED|95.0|-19.7|-16.0|||t-test, 1 sided|||Systolic blood pressure - last 6 hours of dose||-16.0|-19.7|<0.0001
71877672|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-13.3|||<|0.0001|TWO_SIDED|95.0|-14.4|-12.2|||t-test, 1 sided|||24-hour mean diastolic blood pressure||-12.2|-14.4|<0.0001
71877673|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.0|||<|0.0001|TWO_SIDED|95.0|-16.2|-13.8|||t-test, 1 sided|||Mean daytime diastolic blood pressure||-13.8|-16.2|<0.0001
71877674|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.1|||<|0.0001|TWO_SIDED|95.0|-12.4|-9.8|||t-test, 1 sided|||Mean nighttime diastolic blood pressure||-9.8|-12.4|<0.0001
71877675|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.3|||<|0.0001|TWO_SIDED|95.0|-13.8|-10.8|||t-test, 1 sided|||Diastolic blood pressure - last 2 hours of dose||-10.8|-13.8|<0.0001
71877676|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.6|||<|0.0001|TWO_SIDED|95.0|-12.9|-10.2|||t-test, 1 sided|||Diastolic blood pressure - last 4 hours of dose||-10.2|-12.9|<0.0001
71877677|NCT00791258|143274499|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-12.6|-10.0|||t-test, 1 sided|||Diastolic blood pressure - last 6 hours of dose||-10.0|-12.6|<0.0001
71877678|NCT00922480|143274541|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
71877679|NCT00922480|143274542|NON_INFERIORITY|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test||||||0.0001
71877680|NCT04784897|143274543|SUPERIORITY||Cox Proportional Hazard|0.9289||||0.7273|TWO_SIDED|90.0|0.6585|1.3102|||Log Rank|||Main comparison is between Brilacidin 5-dose and Pooled Placebo||1.3102|0.6585|0.7273
71877681|NCT04784897|143274543|SUPERIORITY||Cox Proportional Hazard|0.8968||||0.5975|TWO_SIDED|90.0|0.5464|1.472|||Log Rank|||Secondary comparison between Brilacidin 3-dose and Pooled Placebo||1.4720|0.5464|0.5975
71918062|NCT02711553|143357975|SUPERIORITY||Odds Ratio (OR)|0.5||||0.023|TWO_SIDED|95.0|0.2|0.9|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||0.9|0.2|0.023
71918063|NCT02711553|143357976|SUPERIORITY||Odds Ratio (OR)|1.2||||0.68|TWO_SIDED|95.0|0.6|2.4|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.4|0.6|0.680
71918064|NCT02711553|143357976|SUPERIORITY||Odds Ratio (OR)|1.3||||0.499|TWO_SIDED|95.0|0.6|2.6|||Exact Cochran-Mantel-Haenszel|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|Stratified by randomization strata Geographical Region, Pathological Diagnosis, Metastatic Disease.|||2.6|0.6|0.499
71918065|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.6||0.069|TWO_SIDED|95.0|-2.28|0.09||p-values are from Type 3 sums of squares mixed model repeated measures (MMRM) Model.|MMRM Model|Least Squares (LS) Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||0.09|-2.28|0.069
71918066|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|0.6||0.042|TWO_SIDED|95.0|-2.42|-0.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||PWB||-0.04|-2.42|0.042
71918067|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.51||0.112|TWO_SIDED|95.0|-1.83|0.19||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.19|-1.83|0.112
71918068|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.51||0.505|TWO_SIDED|95.0|-1.35|0.67||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||SWB||0.67|-1.35|0.505
71918069|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.44||0.116|TWO_SIDED|95.0|-1.56|0.17||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.17|-1.56|0.116
71918070|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.45||0.521|TWO_SIDED|95.0|-1.16|0.59||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||EWB||0.59|-1.16|0.521
71918071|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.62||0.008|TWO_SIDED|95.0|-2.87|-0.44||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||-0.44|-2.87|0.008
71918072|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.62||0.335|TWO_SIDED|95.0|-1.82|0.62||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FWB||0.62|-1.82|0.335
71918073|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|0.89||0.001|TWO_SIDED|95.0|-4.69|-1.18||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||-1.18|-4.69|0.001
71918074|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-1.64|STANDARD_ERROR_OF_MEAN|0.89||0.068|TWO_SIDED|95.0|-3.4|0.12||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||HCS||0.12|-3.40|0.068
71918075|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-1.02|STANDARD_ERROR_OF_MEAN|0.52||0.051|TWO_SIDED|95.0|-2.04|0.0||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.00|-2.04|0.051
71918076|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.52||0.212|TWO_SIDED|95.0|-1.68|0.38||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||FACT-Hep||0.38|-1.68|0.212
71918077|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-5.67|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|-9.3|-2.04||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||-2.04|-9.30|0.002
71918078|NCT02711553|143357980|SUPERIORITY||LS Mean Difference|-3.42|STANDARD_ERROR_OF_MEAN|1.85||0.066|TWO_SIDED|95.0|-7.07|0.22||p-values are from type 3 sums of squares MMRM model.|MMRM Model|LS Mean value was adjusted for treatment, visit, baseline, treatment\*visit and baseline\*visit.||TOI||0.22|-7.07|0.066
71918079|NCT05559203|143357987|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.752|||||||t-test, 2 sided|paired sample||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.752
71918080|NCT05559203|143357988|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.197|||||||t-test, 2 sided|||Feasibility study so no power calculation. N = 18 with baseline and follow-up data.||||.197
71918081|NCT05559203|143357989|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.562|||||||t-test, 2 sided|||||||.562
71918082|NCT05559203|143357990|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.02|||||||t-test, 2 sided|||Anxiety subscale||||.020
71918083|NCT05559203|143357990|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.002|||||||t-test, 2 sided|||Depression subscale||||.002
71918084|NCT05559203|143357991|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.036|||||||t-test, 2 sided|||||||.036
71918085|NCT05559203|143357992|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.042|||||||t-test, 2 sided|||||||.042
71918086|NCT05559203|143357993|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71918087|NCT05559203|143357994|EQUIVALENCE|0.05 test of null hypothesis that there will be no significant change from baseline to post-intervention||||||0.781|||||||t-test, 2 sided|||||||.781
71918088|NCT01012037|143358071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.97|-0.52|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-0.52|-0.97|<0.0001
71918089|NCT01012037|143358071|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.02|-0.58|||ANCOVA|||Linagliptin 5mg qd versus Placebo||-0.58|-1.02|<0.0001
71918090|NCT01012037|143358071|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.07|0.19|||ANCOVA|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.19|-0.07|
71918091|NCT01012037|143358072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.83|-0.48|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.48|-0.83|<0.0001
71918092|NCT01012037|143358072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001||95.0|-0.84|-0.49|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.49|-0.84|<0.0001
71918093|NCT01012037|143358072|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.05||||95.0|-0.1|0.1|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.10|-0.10|
71918094|NCT01012037|143358073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.0|-0.54|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-0.54|-1.00|<0.0001
71918095|NCT01012037|143358073|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-1.05|-0.59|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-0.59|-1.05|<0.0001
71918096|NCT01012037|143358073|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.08|0.18|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Linagliptin 5mg qd||0.18|-0.08|
71918097|NCT01012037|143358074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|4.6||0.0029||95.0|-22.7|-4.7|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo||-4.7|-22.7|0.0029
71918098|NCT01012037|143358074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|4.6||0.0001||95.0|-26.7|-8.8|||ANCOVA|||Linagliptin 5 mg qd versus Placebo||-8.8|-26.7|0.0001
71918099|NCT01012037|143358074|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.6||||95.0|-1.0|9.2|||ANCOVA||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||9.2|-1.0|
71918100|NCT01012037|143358075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.6|STANDARD_ERROR_OF_MEAN|4.4||0.0002||95.0|-25.3|-7.8|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||-7.8|-25.3|0.0002
71918101|NCT01012037|143358075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.9|STANDARD_ERROR_OF_MEAN|4.4|<|0.0001||95.0|-27.6|-10.2|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-10.2|-27.6|<0.0001
71918102|NCT01012037|143358075|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|2.5||||95.0|-2.6|7.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||7.3|-2.6|
71918103|NCT01012037|143358076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|5.4||0.0653||95.0|-20.6|0.6|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo||0.6|-20.6|0.0653
71918104|NCT01012037|143358076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3|STANDARD_ERROR_OF_MEAN|5.4||0.0047||95.0|-25.8|-4.7|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo||-4.7|-25.8|0.0047
71918105|NCT01012037|143358076|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|3.0||||95.0|-0.7|11.3|||Mixed Models Analysis||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd||11.3|-0.7|
71918106|NCT00415623|143358090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7|||<|0.001||95.0|-9.0|-4.4|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-4.4|-9.0|<0.001
71918107|NCT00415623|143358091|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|||<|0.001||95.0|-5.7|-2.5|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.5|-5.7|<0.001
71918108|NCT00415623|143358092|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|||<|0.001||95.0|-9.1|-5.1|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-5.1|-9.1|<0.001
71918109|NCT00415623|143358093|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0|||<|0.001||95.0|-5.4|-2.6|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).||-2.6|-5.4|<0.001
71918110|NCT00415623|143358094|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.33||||0.002||95.0|1.36|3.99|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||3.99|1.36|0.002
71918111|NCT00415623|143358095|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.46|||<|0.001||95.0|2.28|8.74|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.74|2.28|<0.001
71918112|NCT00415623|143358096|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.001||95.0|1.5|4.36|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||4.36|1.50|0.001
71918113|NCT00415623|143358097|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.16|||<|0.001||95.0|2.12|8.19|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (\<=64, \>=65) as a factor. The significance level was 0.05 (two-sided).||8.19|2.12|<0.001
71918114|NCT00542425|143358100|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
71918115|NCT00542425|143358100|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.||||<0.001
71918116|NCT00542425|143358101|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
71918117|NCT00542425|143358101|SUPERIORITY_OR_OTHER||||||<|0.001||0.0|||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.||||<0.001
71918118|NCT02059174|143358131|NON_INFERIORITY_OR_EQUIVALENCE|A frailty model was used with effects for treatment, period and sequence and a random effect for participant. A value of 1.00 for the hazard ratio corresponds to no difference between treatments.|Hazard Ratio (HR)|1.07|||||TWO_SIDED|95.0|0.72|1.59|||||ratio (MK-1293 / EU-Approved Lantus)|Because numerous participants did not achieve End of Action within the 30-hour clamp timeframe, the pre-specified hypothesis of similarity with regard to mean DOA could not be tested and a survival analysis approach was undertaken. The hazard rate is a measure of the instantaneous risk of reaching End of Action at time t given End of Action has not been met up until time t, with the hazard ratio being an estimate of the relative difference in hazard rates between treatments.||1.59|0.72|
71918119|NCT02059174|143358132|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.95|||||TWO_SIDED|95.0|0.88|1.01|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.01|0.88|
71918120|NCT02059174|143358133|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.9|||||TWO_SIDED|95.0|0.81|0.99|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.99|0.81|
71918121|NCT02059174|143358134|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.99|||||TWO_SIDED|95.0|0.92|1.06|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.06|0.92|
71918122|NCT02059174|143358135|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria calculated via Fieller's Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.96|||||TWO_SIDED|95.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
71918123|NCT02059174|143358136|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.02|0.91|
71918124|NCT02059174|143358137|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||TWO_SIDED|90.0|0.93|1.03|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.03|0.93|
71918125|NCT02059174|143358138|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.86|0.97|||||Ratio (MK-1293 / EU-Approved Lantus)|||0.97|0.86|
71918126|NCT02059174|143358139|NON_INFERIORITY_OR_EQUIVALENCE|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|1.0|||||TWO_SIDED|90.0|0.95|1.04|||||Ratio (MK-1293 / EU-Approved Lantus)|||1.04|0.95|
71918127|NCT00087594|143358150|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-27.8|41.3||||||95% CI for G1 participants||41.3|-27.8|
71918128|NCT00087594|143358150|SUPERIORITY_OR_OTHER||Difference|13.0|||||TWO_SIDED|95.0|-10.4|35.4||||||95% CI for G2/3 participants||35.4|-10.4|
71918129|NCT00087594|143358150|SUPERIORITY_OR_OTHER||Difference|44.0|||||TWO_SIDED|95.0|12.0|76.9||||||95% CI for G1 participants with 2 log drop at W 12||76.9|12.0|
71877682|NCT04667377|143274562|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Linear model fit|||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
71877683|NCT04667377|143274562|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Exponential model fit|Model Assumption: 50% of maximum effect achieved at dose 3.6 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
71877684|NCT04667377|143274562|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax1 model fit|Model Assumption: 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
71877685|NCT04667377|143274562|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Emax2 model fit|Model Assumption: 70% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
71883064|NCT00385255|143285394|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-1.17|||||TWO_SIDED|95.0|-3.58|1.23||||||Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.23|-3.58|
71918130|NCT00087594|143358150|SUPERIORITY_OR_OTHER||Difference|0.0|||||TWO_SIDED|||||||||95% CI for G1 participants with non 2 log drop at W 12||||
71918131|NCT00087594|143358150|SUPERIORITY_OR_OTHER||Difference|-13.0|||||TWO_SIDED|95.0|-77.2|50.5||||||95% CI for G1 participants with missing HCV-RNA at W 12||50.5|-77.2|
71918132|NCT01901809|143358165|SUPERIORITY||Mean Difference (Net)|11.4|STANDARD_ERROR_OF_MEAN|4.7||0.018|TWO_SIDED|95.0|2.0|20.8|||t-test, 2 sided|||||20.8|2.0|0.018
71918133|NCT01901809|143358166|SUPERIORITY||Mean Difference (Net)|-4.8|STANDARD_ERROR_OF_MEAN|4.8||0.33|TWO_SIDED|95.0|-14.4|4.9|||t-test, 2 sided|||||4.9|-14.4|0.33
71918134|NCT01952041|143358167|SUPERIORITY|||||||0.8|||||||Chi-squared|Chi-square test statistic=0.06, degrees of freedom=2||||||0.80
71918135|NCT01952041|143358168|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.43|TWO_SIDED|95.0|0.42|1.44|||Regression, Cox||Hazard ratio is intervention arm vs. TAU for time to first relapse from randomization. There is not a standard error (SE) that directly links to the hazard ratio. The confidence interval provided illustrates the dispersion for the hazard ratio.|||1.44|0.42|0.43
71918136|NCT01952041|143358169|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.41||0.58|TWO_SIDED|95.0|-0.58|1.02|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||1.02|-0.58|0.58
71918137|NCT01952041|143358170|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.84|TWO_SIDED|95.0|-0.22|0.26|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.26|-0.22|0.84
71918138|NCT01952041|143358171|SUPERIORITY||Slope|-2.7|STANDARD_ERROR_OF_MEAN|1.4||0.06|TWO_SIDED|95.0|-5.4|0.04|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.|||0.04|-5.40|0.06
71918139|NCT03650387|143358179|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
71918140|NCT03650387|143358180|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
71918141|NCT03650387|143358181|OTHER||||||<|0.0001||||||Bonferroni-Holm was used for alpha correction.|Exact one-sample binomial test|The one-sample binomial test was used to test whether the probability of being a responder (p) is significantly above 60%.||||||< 0.0001
71685076|NCT01687283|142888664|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-1.8||||0.733|TWO_SIDED|95.0|-12.19|8.59||Analysis performed using ANCOVA with covariates of baseline, center, sex, age and treatment|ANCOVA||The analysis only included participants who had at least 4 days of non-missing AM PEF data in the baseline week prior to randomization and at least 4 days of non-missing AM PEF data after randomization.|||8.59|-12.19|0.733
71685077|NCT01687283|142888665|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-2.28||||0.674|TWO_SIDED|95.0|-12.95|8.38|||ANCOVA|||||8.38|-12.95|0.674
71685078|NCT01687283|142888666|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.77||||0.579|TWO_SIDED|95.0|-12.57|7.04|||ANCOVA|||||7.04|-12.57|0.579
71877686|NCT04667377|143274562|OTHER|Covariate adjusted fixed effect estimates of mean percentage change in body weight at Week 46 for each treatment group with associated covariance matrix were extracted from the MMRM (including fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors) and used as input for the MCP-Mod.|||||<|0.0001||||||P-value is adjusted for multiplicity.|MCP-Mod - Sigmoid Emax model fit|Model Assumption: 50% of maximum effect achieved at dose 2.4 mg, 90% of maximum effect achieved at dose 4.8 mg.||A flat vs. non-flat dose-response relationship across the 4 doses of BI 456906 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different potential dose-response patterns (Linear, Exponential, Emax1, Emax2, Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 2.5%).||||<0.0001
71877687|NCT04667377|143274562|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.37|STANDARD_ERROR_OF_MEAN|1.5||0.0257|TWO_SIDED|95.0|-6.33|-0.41||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.41|-6.33|0.0257
71877688|NCT04667377|143274562|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-9.69|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-12.57|-6.81||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation as used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-6.81|-12.57|<.0001
71877689|NCT04667377|143274562|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-10.4|STANDARD_ERROR_OF_MEAN|1.48|<|0.0001|TWO_SIDED|95.0|-13.32|-7.49||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.49|-13.32|<.0001
71877690|NCT04667377|143274562|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.12|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-15.0|-9.24||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation will be used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.24|-15.00|<.0001
71877691|NCT04667377|143274563|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.28||||0.0015|TWO_SIDED|95.0|1.57|6.84||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||6.84|1.57|0.0015
71918142|NCT01569568|143358188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PCGM.||||0.001
71685079|NCT01687283|142888667|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.62||||0.854|TWO_SIDED|95.0|-6.0|7.24|||ANCOVA|||||7.24|-6.00|0.854
71685080|NCT01687283|142888668|SUPERIORITY_OR_OTHER|||||||0.123|||||||Wilcoxon rank sum test|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median day-time symptom score||||0.123
71685081|NCT01687283|142888668|SUPERIORITY_OR_OTHER|||||||0.949|||||||Wilcoxon rank sum test.|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median night-time symptom score||||0.949
71685082|NCT01687283|142888669|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.74||||0.204|TWO_SIDED|95.0|-12.07|2.59|||ANCOVA|||||2.59|-12.07|0.204
71685083|NCT01687283|142888670|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Wilcoxon Rank sum|||||||0.170
71758584|NCT02494323|143019444|SUPERIORITY_OR_OTHER||||||<|0.01||||||P value is adjusted for the comparison of subjects who benefited, were satisfied and willing to continue using the Segmented Electrodes versus subjects who didn't benefit, wern't satisfied ans were not willing to continue using the Segmented Eletrode|t-test, 1 sided|||||||<0.01
71685084|NCT01687283|142888671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.039||||0.337|TWO_SIDED|95.0|-0.118|0.041||Repeated Measures analysis adjusted for baseline, centre, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 2||0.041|-0.118|0.337
71685085|NCT01687283|142888671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.008||||0.866|TWO_SIDED|95.0|-0.101|0.085||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 4||0.085|-0.101|0.866
71685086|NCT01687283|142888671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.025||||0.566|TWO_SIDED|95.0|-0.113|0.062||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 8||0.062|-0.113|0.566
71918143|NCT01569568|143358188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.011|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PCGM.||||0.011
71918144|NCT01569568|143358188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PWM.||||0.004
71918145|NCT01569568|143358188|SUPERIORITY_OR_OTHER_LEGACY|||||||0.046|TWO_SIDED|||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PWM.||||0.046
71918146|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the DMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all DMN nodes is the same across groups.||||<0.001
71685087|NCT01687283|142888671|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.017||||0.727|TWO_SIDED|95.0|-0.078|0.112||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 12||0.112|-0.078|0.727
71918147|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the left IPL node does not differ between groups.||||0.024
71918148|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold is 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the PCC node does not differ between groups.||||0.040
71918149|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the right IPL node does not differ between groups.||||0.008
71918150|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left IPL node and the right IPL node does not differ between groups.||||0.470
71918151|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.829|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the left IPL node does not differ between groups.||||0.829
71918152|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.801|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the right IPL node does not differ between groups.||||0.801
71918153|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the SMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all SMN nodes is the same across groups.||||<0.001
71685088|NCT01663857|142888679|SUPERIORITY|||||||0.4|||||||Log Rank|||||||0.4
71685089|NCT01663857|142888681|SUPERIORITY|||||||0.4686|||||||Log Rank|||||||0.4686
71685090|NCT03041467|142888684|SUPERIORITY||||||<|0.001|||||||One-sided Z-test|||||||<0.001
71877692|NCT04667377|143274563|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|8.83|||<|0.0001|TWO_SIDED|95.0|4.0|19.46||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||19.46|4.00|<.0001
71877693|NCT04667377|143274563|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|7.48|||<|0.0001|TWO_SIDED|95.0|3.41|16.41||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||16.41|3.41|<.0001
71877694|NCT04667377|143274563|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 5% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.77|||<|0.0001|TWO_SIDED|95.0|4.77|24.31||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||24.31|4.77|<.0001
71877695|NCT04667377|143274564|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|3.22||||0.012|TWO_SIDED|95.0|1.29|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|1.29|0.0120
71877696|NCT04667377|143274564|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|10.62|||<|0.0001|TWO_SIDED|95.0|4.36|25.86||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||25.86|4.36|<.0001
71877697|NCT04667377|143274564|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.78|||<|0.0001|TWO_SIDED|95.0|4.02|23.79||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||23.79|4.02|<.0001
71882620|NCT02706873|143284637|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|21.6|||<|0.001|TWO_SIDED|95.0|14.3|28.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||28.8|14.3|<0.001
71918154|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left aI/fO node does not differ between groups.||||0.550
71918155|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.113|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left SFG node does not differ between groups.||||0.113
71918156|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right aI/fO node does not differ between groups.||||0.039
71918157|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right SFG node does not differ between groups.||||0.005
71918158|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.426|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the left SFG node does not differ between groups.||||0.426
71918159|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.256|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO node and the right aI/fO node does not differ between groups.||||0.256
71918160|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the right SFG node does not differ between groups.||||0.853
71918161|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the left SFG node does not differ between groups.||||0.003
71918162|NCT01569568|143358189|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|TWO_SIDED|||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the right SFG node does not differ between groups.||||0.023
71918163|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.929|TWO_SIDED|||||Equal variance is not assumed. Two tailed t-test WASI verbal IQ between cases and controls|t-test, 2 sided|||||||.929
71918164|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||Equal variance not assumed. Comparison WASI performance IQ cases and controls|t-test, 2 sided|||||||.002
71918165|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.094|TWO_SIDED|||||Equal variance not assumed. Comparison of WASI full IQ cases and controls|t-test, 2 sided|||||||.094
71918166|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.853|TWO_SIDED|||||Equal variance not assumed. Comparison of CTMT global composite score between cases and controls|t-test, 2 sided|||||||.853
71918167|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||Equal variance not assumed. Comparison of BRIEF BRI cases and controls|t-test, 2 sided|||||||.001
71918168|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF MI cases and controls|t-test, 2 sided|||||||<.001
71918169|NCT01569568|143358191|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Equal variances not assumed. Comparison of BRIEF GEC between cases and controls.|t-test, 2 sided|||||||<0.001
71918170|NCT02274311|143358216|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||"Measures of central tendency (mean) and variability (range and/or SD) were used to describe numeric variables. Paired Student's t test was used to verify the mean differences between dependent normally distributed variables. Wilcoxon sign test was performed to non-normally distributed dependent variables.~Asignificance level of 5%was adopted for all statistical tests (P \<.05)."||||< 0.05
71918171|NCT02477800|143358228|SUPERIORITY||Difference from Placebo|0.11||||0.225|TWO_SIDED|95.0|-0.469|0.403|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.403|-0.469|0.2250
71918172|NCT02477800|143358228|SUPERIORITY||Difference from late start group|0.03||||0.833|TWO_SIDED|95.0|-0.262|0.326|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in CDR-SB as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline CDR-SB, baseline CDR-SB by visit interaction, baseline MMSE, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.326|-0.262|0.8330
71918173|NCT02477800|143358229|SUPERIORITY||Difference from Placebo|0.2||||0.4795|TWO_SIDED|95.0|-0.35|0.74|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.74|-0.35|0.4795
71918174|NCT02477800|143358229|SUPERIORITY||Difference from Placebo|-0.1||||0.8106|TWO_SIDED|95.0|-0.62|0.49|||MMRM Model|||Adjusted mean for each treatment group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference from Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in MMSE as dependent variable and with fixed effects of treatment group, categorical visit, treatment-by-visit interaction, baseline MMSE, baseline MMSE by visit interaction, AD symptomatic medication use at baseline, region, and laboratory ApoE status.||0.49|-0.62|0.8106
71918175|NCT02477800|143358230|SUPERIORITY||Difference from Placebo|-0.583||||0.2536|TWO_SIDED|95.0|-1.5835|0.4181|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4181|-1.5835|0.2536
71918176|NCT02477800|143358230|SUPERIORITY||Difference from Placebo|-0.588||||0.2578|TWO_SIDED|95.0|-1.6067|0.4309|||MMRM Model|||Adjusted mean for each treatment group (Placebo,BIIB037 Low Dose,BIIB037 High Dose),difference with Placebo, 95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADAS-Cog 13 as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction,baseline ADAS-Cog 13,baseline ADAS-Cog 13 by visit interaction,baseline MMSE,AD symptomatic medication use at baseline,region,and laboratory ApoE status.||0.4309|-1.6067|0.2578
71918177|NCT02477800|143358231|SUPERIORITY||Difference from Placebo|0.7||||0.1225|TWO_SIDED|95.0|-0.19|1.64|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.64|-0.19|0.1225
71918178|NCT02477800|143358231|SUPERIORITY||Difference from late start group|0.7||||0.1506|TWO_SIDED|95.0|-0.25|1.61|||MMRM Model|||Adjusted mean for each group (Placebo, BIIB037 Low Dose, BIIB037 High Dose), difference with Placebo,95% confidence interval and p-value at each time point were based on an MMRM model, with change from baseline in ADCS-ADL-MCI as dependent variable and with fixed effects of treatment group,categorical visit,treatment-by-visit interaction, baseline ADCS-ADL-MCI, baseline ADCS-ADL-MCI by visit interaction, baseline MMSE AD symptomatic medication use at baseline,region, and laboratory ApoE status.||1.61|-0.25|0.1506
71918179|NCT01948518|143358242|SUPERIORITY_OR_OTHER||||||=|0.3|TWO_SIDED||||||t-test, 2 sided|||Assuming 15% change in absolute value of DLCO representing a significant clinical difference and a standard deviation of 17.4% in normal nonsmoking individuals \[Miller A, Thornton JC, Warshaw R, et al. Am Rev Respir Dis. 1983;127 (suppl 3):270-277.\], 13 subjects needed to be studied to reject the null hypothesis when there is no significant difference between DLCO measurements before and after sildenafil, with power 0.8 and type I error probability 0.05 (SAS 9.2, SAS Institute Inc., Cary, NC)||||=0.30
71918180|NCT01948518|143358243|SUPERIORITY_OR_OTHER||||||=|0.63|||||||t-test, 2 sided|||The average 6 minute walk distance at baseline was 1195±407 feet. After oral administration of sildenafil, 6 minute walk distance was 1214±383 feet (p=0.63).||||=0.63
71918181|NCT00170846|143358244|SUPERIORITY_OR_OTHER||Difference in LS means|1.1241||||0.6332|TWO_SIDED|95.0|-3.5077|5.7559|||ANCOVA|||||5.7559|-3.5077|0.6332
71918182|NCT00170846|143358244|SUPERIORITY_OR_OTHER||Difference in LS means|0.5933||||0.7943|TWO_SIDED|95.0|-3.8815|5.0682|||ANCOVA|||||5.0682|-3.8815|0.7943
71922307|NCT00453349|143365035|NON_INFERIORITY_OR_EQUIVALENCE|"The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference..., pg.1447-1454 \[1990\]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population"|Mean Difference (Final Values)|-3.2||||||95.0|-10.7|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-10.7|
71685091|NCT03041467|142888685|NON_INFERIORITY|Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.||||||0.002|||||||Farrington-Manning Test|||||||0.002
71685092|NCT03041467|142888686|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Log Rank|||Kaplan-Meier method was used to estimate access circuit primary patency.||||<0.001
71685093|NCT03041467|142888687|OTHER|There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months. Survival analysis was performed using Kaplan-Meier method.|Log Rank|||Kaplan-Meier method was used to estimate target lesion primary patency.|Survival analysis was performed using Kaplan-Meier method.|||<0.001
71685094|NCT03041467|142888688|SUPERIORITY||||||<|0.001||||||There is no planned hypothesis test other than at 6 months time point. P-value listed is at 6 months.|Chi-squared|||||||<0.001
71685095|NCT03041467|142888692|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
71685096|NCT03041467|142888693|SUPERIORITY|||||||0.482|||||||Chi-squared|||||||0.482
71918183|NCT01756833|143358253|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.035||0.71|TWO_SIDED|95.0|-0.07|0.07||Two prespecified interim analyses for efficacy performed when 1/3 \& 2/3 of primary outcome available, significance level, 1-sided, alpha=.0005. Final analysis 1-sided, alpha=.024. Futility analysis performed when \~2/3 primary outcome was available.|ANCOVA on normal scores|||"Null hypothesis: normal score of MTD at follow-up adjusted for baseline and gender in doxycycline assigned patients - normal score of MTD at follow-up adjusted for baseline and gender in placebo assigned patients = 0.~Sample size: The criterion (alpha) set for statistical significance was 1-sided .025; use of this level means that the inference from the test result will be the same as the inference from 2-sided testing at the .05 significance level."|For the primary analysis, diameters at baseline were ranked from smallest to largest (ranks 1-254). At the 2-year follow-up, ranks 1 through 225 were assigned to the diameters of surviving patients with no aneurysm repair (with missing values estimated by multiple imputation), ranks 226 through 247 were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and ranks 248 through 254 were assigned to patients who died (in order of longest to shortest time from randomization to death). Each rank was converted to a normal score corresponding to the value on the standard normal curve (z score) of its percentile among all 254 ranks. The primary analysis was based on linear regression of the change in normal scores from baseline to 2 years. Independent variables were baseline normal score, sex, and a dichotomous variable for the randomly assigned treatment group (0 for placebo, 1 for doxycycline).|0.07|-0.07|0.71
71685097|NCT03041467|142888694|SUPERIORITY||||||>|0.999|||||||Chi-squared|||||||>0.999
71918184|NCT01700140|143358267|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.0000
71918185|NCT01700140|143358267|SUPERIORITY_OR_OTHER|||||||0.2284|||||||Fisher Exact|||||||0.2284
71918186|NCT01700140|143358267|SUPERIORITY_OR_OTHER|||||||0.2549|||||||Cochran-Armitage test|||||||0.2549
71918187|NCT01700140|143358268|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71685098|NCT03052920|142888704|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 11.29||Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.||||<0.001
71685099|NCT03052920|142888705|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<=0.05|t-test, 2 sided|t(35) = 16.947||Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.||||<0.001
71918188|NCT01700140|143358268|SUPERIORITY_OR_OTHER|||||||0.1527|||||||Fisher Exact|||||||0.1527
71918189|NCT01700140|143358268|SUPERIORITY_OR_OTHER|||||||0.1864|||||||Cochran-Armitage test|||||||0.1864
71918190|NCT01700140|143358269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.918||||0.8361|TWO_SIDED|95.0|0.266|3.172|||Generalized Wilcoxon test|||||3.172|0.266|0.8361
71685100|NCT03052920|142888706|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05|t-test, 2 sided|t(35) = 2.14||Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.||||<0.05
71685101|NCT03052920|142888707|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 4.02||Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.||||<0.001
71685102|NCT03052920|142888708|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.58||Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.||||<0.05
71685103|NCT03052920|142888709|SUPERIORITY||||||<|0.01||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 3.16||Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.||||<0.01
71685104|NCT03052920|142888710|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 10.42||Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.||||<0.001
71685105|NCT03052920|142888711|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.15||Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.||||<0.001
71685106|NCT03052920|142888712|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 4.34||Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.||||<0.001
71685107|NCT03052920|142888713|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.71||Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.||||<0.001
71685108|NCT03052920|142888714|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 7.90||Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.||||<0.001
71685109|NCT03052920|142888715|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(38) = 2.31||Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.||||<0.05
71918191|NCT01700140|143358269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.423||||0.0724|TWO_SIDED|95.0|0.144|1.237|||Generalized Wilcoxon test|||||1.237|0.144|0.0724
71918192|NCT01700140|143358270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.213||||0.6466|TWO_SIDED|95.0|0.616|2.388|||Generalized Wilcoxon test|||||2.388|0.616|0.6466
71918193|NCT01700140|143358270|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.828||||0.2701|TWO_SIDED|95.0|0.566|1.21|||Generalized Wilcoxon test|||||1.210|0.566|0.2701
71685110|NCT03052920|142888716|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.27||Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.||||<0.001
71685111|NCT03052920|142888717|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(25) = 7.65||Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.||||<0.001
71685112|NCT03052920|142888718|SUPERIORITY||||||<|0.05||||||The threshold for statistical significance was \<= 0.05.|t-test, 2 sided|t(35) = 2.34||Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.||||<0.05
71685113|NCT00592592|142888876|OTHER||Cumulative incidence|10.9|||||TWO_SIDED|95.0|5.7|18.0||||||||18.0|5.7|
71685114|NCT00592592|142888878|OTHER||% hypothalamus normal tissue spared|88.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
71685115|NCT00592592|142888878|OTHER||% pituitary normal tissue spared|73.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
71918194|NCT01700140|143358271|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||1.0000
71685116|NCT00592592|142888878|OTHER||% lens (contra) normal tissue spared|100.0|||<|0.01|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||<0.01
71685117|NCT00592592|142888878|OTHER||% maxilla normal tissue spared|42.0||||0.02|TWO_SIDED||||||t-test, 2 sided|Paired t-test||||||0.02
71685118|NCT00592592|142888879|OTHER||Percent Survival, Local Control|80.9|||||TWO_SIDED|95.0|73.0|87.7||||||||87.7|73.0|
71918195|NCT01700140|143358271|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation||||0.1051
71918196|NCT01700140|143358271|SUPERIORITY_OR_OTHER|||||||0.4856|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.4856
71918197|NCT01700140|143358271|SUPERIORITY_OR_OTHER|||||||0.1047|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation||||0.1047
71918198|NCT01700140|143358271|SUPERIORITY_OR_OTHER|||||||0.1617|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.1617
71918199|NCT01700140|143358271|SUPERIORITY_OR_OTHER|||||||0.3099|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation||||0.3099
71918200|NCT01700140|143358272|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||1.0000
71918201|NCT01700140|143358272|SUPERIORITY_OR_OTHER|||||||0.1051|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation||||0.1051
71918202|NCT01700140|143358272|SUPERIORITY_OR_OTHER|||||||0.6761|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.6761
71918203|NCT01700140|143358272|SUPERIORITY_OR_OTHER|||||||0.3513|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation||||0.3513
71918204|NCT01700140|143358272|SUPERIORITY_OR_OTHER|||||||0.206|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.2060
71918205|NCT01700140|143358272|SUPERIORITY_OR_OTHER|||||||0.0511|TWO_SIDED||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation||||0.0511
71918206|NCT02573012|143358276|SUPERIORITY||Least Square Means|0.613||||0.001|TWO_SIDED|95.0|0.346|0.879|||ANCOVA|||||0.879|0.346|0.001
71918207|NCT02573012|143358277|SUPERIORITY||Odds Ratio (OR)|0.5||||0.018|TWO_SIDED|95.0|0.285|0.889|||Regression, Logistic|||||0.889|0.285|0.018
71918208|NCT02573012|143358277|SUPERIORITY||Relative Risk|0.833||||0.021|TWO_SIDED|95.0|0.714|0.972|||Cochran-Mantel-Haenszel|||||0.972|0.714|0.021
71918209|NCT02573012|143358278|SUPERIORITY||Least Square Mean|2.342||||0.006|TWO_SIDED|95.0|0.661|4.023|||ANCOVA|||||4.023|0.661|0.006
71918210|NCT02573012|143358298|SUPERIORITY||Least Square Means|2.264||||0.009||95.0|0.574|3.953|||ANCOVA|||||3.953|0.574|0.009
71918211|NCT01601873|143358299|SUPERIORITY|||||||0.884|||||||Wilcoxon (Mann-Whitney)|||||||0.884
71918212|NCT01601873|143358300|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71918213|NCT01601873|143358301|SUPERIORITY|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||||||0.294
71918214|NCT01601873|143358302|SUPERIORITY|||||||0.538|||||||Log Rank|||||||0.538
71918215|NCT01601873|143358303|SUPERIORITY|||||||0.786|||||||Log Rank|||||||0.786
71918216|NCT01601873|143358304|SUPERIORITY|||||||0.185|||||||Log Rank|||||||0.185
71918217|NCT02096471|143358314|SUPERIORITY|Single group study. Change in Pain from Baseline amongst those with a tumor response|Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|0.84||0.11|TWO_SIDED||||||t-test, 2 sided|Descriptive analysis only||Single group change from baseline||||0.11
71918218|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|0.8||0.01|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.01
71918219|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.66||0.18|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.18
71918220|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life (QOL) from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.77|STANDARD_ERROR_OF_MEAN|3.6||0.3|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.30
71918221|NCT02096471|143358314|SUPERIORITY|Single Group Study Change in Quality of Life from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.55|STANDARD_ERROR_OF_MEAN|6.87||0.61|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.61
71918222|NCT02096471|143358314|SUPERIORITY|Single Group Study Change in Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-13.06|STANDARD_ERROR_OF_MEAN|8.29||0.12|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.12
71918223|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-12.98|STANDARD_ERROR_OF_MEAN|6.35||0.05|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only.||Single Group Change from Baseline||||0.05
71918224|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|6.66|STANDARD_ERROR_OF_MEAN|5.05||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
71918225|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|6.46||0.72|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.72
71918226|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.24|STANDARD_ERROR_OF_MEAN|6.74||0.36|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.36
71918227|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|6.37||0.98|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.98
71918228|NCT02096471|143358314|SUPERIORITY|Single Group Study. change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|0.68|STANDARD_ERROR_OF_MEAN|7.99||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
71918229|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-10.97|STANDARD_ERROR_OF_MEAN|8.16||0.19|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.19
71918230|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-3.74|STANDARD_ERROR_OF_MEAN|6.58||0.57|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.57
71918231|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-4.21|STANDARD_ERROR_OF_MEAN|5.51||0.45|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.45
71918232|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.27|STANDARD_ERROR_OF_MEAN|5.72||0.28|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.28
71918233|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|8.52||0.93|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.93
71918234|NCT02096471|143358314|SUPERIORITY|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|7.53||0.89|TWO_SIDED||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline||||0.89
71882621|NCT02706873|143284637|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|15.7|30.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||30.1|15.7|<0.001
71918235|NCT01610414|143358317|SUPERIORITY|Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.|Vaccine efficacy|68.17|||<|0.0001|TWO_SIDED|95.0|55.56|77.53|||Poisson method|||Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.||77.53|55.56|<0.0001
71918236|NCT02483611|143358344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|149.0|STANDARD_DEVIATION|46.07||0.9651|TWO_SIDED|95.0|88.0|235.0|||ANOVA|||||235|88|0.9651
71918237|NCT02483611|143358344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|145.3|STANDARD_DEVIATION|42.48||0.9651|TWO_SIDED|95.0|78.0|244.0|||ANOVA|||||244|78|0.9651
71918238|NCT02483611|143358344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|147.8|STANDARD_DEVIATION|29.75||0.9651|TWO_SIDED|95.0|105.0|200.0|||ANOVA|||The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.||200|105|0.9651
71918239|NCT02483611|143358345|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|82.68|||<|0.0001|TWO_SIDED|95.0|72.62|99.27|||Kruskal-Wallis|||||99.27|72.62|<0.0001
71918240|NCT02483611|143358345|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|86.33|||<|0.0001|TWO_SIDED|95.0|71.78|140.6|||Kruskal-Wallis|||||140.60|71.78|<0.0001
71918241|NCT02483611|143358345|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.8|||<|0.0001|TWO_SIDED|95.0|40.5|92.9|||Kruskal-Wallis|||||92.90|40.50|<0.0001
71918242|NCT02483611|143358346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.08|STANDARD_DEVIATION|6.49||0.0015|TWO_SIDED|95.0|12.0|32.25|||ANOVA|||||32.25|12.00|0.0015
71918243|NCT02483611|143358346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.26|STANDARD_DEVIATION|7.69||0.0015|TWO_SIDED|95.0|10.5|39.83|||ANOVA|||||39.83|10.50|0.0015
71918244|NCT02483611|143358346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.53|STANDARD_DEVIATION|1.52||0.0015|TWO_SIDED|95.0|11.0|16.5|||ANOVA|||||16.50|11.00|0.0015
71918245|NCT02483611|143358347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.97|STANDARD_DEVIATION|6.77||0.0003|TWO_SIDED|95.0|19.5|41.5|||ANOVA|||||41.50|19.50|0.0003
71918246|NCT02483611|143358347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.81|STANDARD_DEVIATION|10.97||0.0003|TWO_SIDED|95.0|18.5|49.5|||ANOVA|||||49.50|18.50|0.0003
71918247|NCT02483611|143358347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|STANDARD_DEVIATION|3.28||0.0003|TWO_SIDED|95.0|17.5|30.05|||ANOVA|||||30.05|17.50|0.0003
71918248|NCT02483611|143358348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.2|STANDARD_DEVIATION|12.16|<|0.0001|TWO_SIDED|95.0|94.87|136.8|||ANOVA|||||136.80|94.87|<0.0001
71918249|NCT02483611|143358348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.1|STANDARD_DEVIATION|18.2|<|0.0001|TWO_SIDED|95.0|95.82|163.3|||ANOVA|||||163.30|95.82|<0.0001
71918250|NCT02483611|143358348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.19|STANDARD_DEVIATION|16.34|<|0.0001|TWO_SIDED|95.0|58.0|125.2|||ANOVA|||||125.20|58|<0.0001
71918251|NCT02483611|143358349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|120.2|STANDARD_DEVIATION|10.88|<|0.0001|TWO_SIDED|95.0|106.3|140.2|||ANOVA|||||140.20|106.30|<0.0001
71918252|NCT02483611|143358349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|126.7|STANDARD_DEVIATION|14.19|<|0.0001|TWO_SIDED|95.0|106.5|149.4|||ANOVA|||||149.40|106.50|<0.0001
71918253|NCT02483611|143358349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.03|STANDARD_DEVIATION|12.78|<|0.0001|TWO_SIDED|95.0|71.75|116.4|||ANOVA|||||116.40|71.75|<0.0001
71918254|NCT02483611|143358350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|94.63|STANDARD_DEVIATION|10.18||0.0527|TWO_SIDED|95.0|70.0|112.0|||ANOVA|||||112.00|70.00|0.0527
71918255|NCT02483611|143358350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88.75|STANDARD_DEVIATION|10.05||0.0527|TWO_SIDED|95.0|65.0|104.0|||ANOVA|||||104.00|65.00|0.0527
71918256|NCT02483611|143358350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.1|STANDARD_DEVIATION|16.62||0.0527|TWO_SIDED|95.0|70.0|140.0|||ANOVA|||||140.00|70.00|0.0527
71918257|NCT02483611|143358351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|87.63|STANDARD_DEVIATION|12.1||0.1996|TWO_SIDED|95.0|60.0|110.0|||ANOVA|||||110.00|60.00|0.1996
71918258|NCT02483611|143358351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|84.69|STANDARD_DEVIATION|11.38||0.1996|TWO_SIDED|95.0|67.0|109.0|||ANOVA|||||109.00|67.00|0.1996
71918259|NCT02483611|143358351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.47|STANDARD_DEVIATION|12.3||0.1996|TWO_SIDED|95.0|73.0|112.0|||ANOVA|||||112.00|73.00|0.1996
71918260|NCT02483611|143358352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.88|STANDARD_DEVIATION|11.95||0.7145|TWO_SIDED|95.0|58.0|107.0|||ANOVA|||||107.00|58.00|0.7145
71918261|NCT02483611|143358352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.88|STANDARD_DEVIATION|9.8||0.7145|TWO_SIDED|95.0|59.0|97.0|||ANOVA|||||97.00|59.00|0.7145
71918262|NCT02483611|143358352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.73|STANDARD_DEVIATION|7.48||0.7145|TWO_SIDED|95.0|58.0|86.0|||ANOVA|||||86.00|58.00|0.7145
71918263|NCT02483611|143358353|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.113|TWO_SIDED|95.0|57.0|96.0|||Kruskal-Wallis|||||96.00|57.00|0.1130
71918264|NCT02483611|143358353|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.113|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1130
71918265|NCT02483611|143358353|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|74.0||||0.113|TWO_SIDED|95.0|59.0|83.0|||Kruskal-Wallis|||||83.00|59.00|0.1130
71918266|NCT02483611|143358354|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.5||||0.0731|TWO_SIDED|95.0|58.0|98.0|||Kruskal-Wallis|||||98.00|58.00|0.0731
71918267|NCT02483611|143358354|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0731|TWO_SIDED|95.0|55.0|74.0|||Kruskal-Wallis|||||74.00|55.00|0.0731
71882622|NCT02706873|143284638|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Least Squares (LS) Mean Difference|-0.53||||0.001|TWO_SIDED|95.0|-0.85|-0.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, geographic region as fixed factors and baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.20|-0.85|0.001
71918268|NCT02483611|143358354|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|67.0||||0.0731|TWO_SIDED|95.0|56.0|85.0|||Kruskal-Wallis|||||85.00|56.00|0.0731
71918269|NCT02483611|143358355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.1002|TWO_SIDED|95.0|60.0|85.0|||Kruskal-Wallis|||||85.00|60.00|0.1002
71918270|NCT02483611|143358355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.1002|TWO_SIDED|95.0|56.0|74.0|||Kruskal-Wallis|||||74.00|56.00|0.1002
71918271|NCT02483611|143358355|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.1002|TWO_SIDED|95.0|60.0|90.0|||Kruskal-Wallis|||||90.00|60.00|0.1002
71918272|NCT02483611|143358356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.94|STANDARD_DEVIATION|15.79||0.4338|TWO_SIDED|95.0|52.0|109.0|||ANOVA|||||109.00|52.00|0.4338
71918273|NCT02483611|143358356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.25|STANDARD_DEVIATION|12.13||0.4338|TWO_SIDED|95.0|55.0|95.0|||ANOVA|||||95.00|55.00|0.4338
71918274|NCT02483611|143358356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.67|STANDARD_DEVIATION|11.82||0.4338|TWO_SIDED|95.0|55.0|92.0|||ANOVA|||||92.00|55.00|0.4338
71918275|NCT02483611|143358357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.69|STANDARD_DEVIATION|11.76||0.9167|TWO_SIDED|95.0|57.0|99.0|||ANOVA|||||99.00|57.00|0.9167
71918276|NCT02483611|143358357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.69|STANDARD_DEVIATION|11.18||0.9167|TWO_SIDED|95.0|51.0|96.0|||ANOVA|||||96.00|51.00|0.9167
71918277|NCT02483611|143358357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.9167|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.9167
71918278|NCT02483611|143358358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.94|STANDARD_DEVIATION|10.96||0.8067|TWO_SIDED|95.0|58.0|92.0|||ANOVA|||||92.00|58.00|0.8067
71918279|NCT02483611|143358358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|74.19|STANDARD_DEVIATION|8.65||0.8067|TWO_SIDED|95.0|57.0|86.0|||ANOVA|||||86.00|57.00|0.8067
71918280|NCT02483611|143358358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|75.4|STANDARD_DEVIATION|11.54||0.8067|TWO_SIDED|95.0|53.0|90.0|||ANOVA|||||90.00|53.00|0.8067
71918281|NCT02483611|143358359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|71.94|STANDARD_DEVIATION|10.87||0.1015|TWO_SIDED|95.0|57.0|93.0|||ANOVA|||||93.00|57.00|0.1015
71918282|NCT02483611|143358359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|72.25|STANDARD_DEVIATION|9.78||0.1015|TWO_SIDED|95.0|52.0|89.0|||ANOVA|||||89.00|52.00|0.1015
71918283|NCT02483611|143358359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.07|STANDARD_DEVIATION|10.01||0.1015|TWO_SIDED|95.0|44.0|81.0|||ANOVA|||||81.00|44.00|0.1015
71918284|NCT02483611|143358360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.56|STANDARD_DEVIATION|10.05||0.3423|TWO_SIDED|95.0|56.0|92.0|||ANOVA|||||92.00|56.00|0.3423
71918285|NCT02483611|143358360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.31|STANDARD_DEVIATION|7.73||0.3423|TWO_SIDED|95.0|57.0|83.0|||ANOVA|||||83.00|57.00|0.3423
71918286|NCT02483611|143358360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.27|STANDARD_DEVIATION|10.81||0.3423|TWO_SIDED|95.0|41.0|81.0|||ANOVA|||||81.00|41.00|0.3423
71918287|NCT02483611|143358361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.5|STANDARD_DEVIATION|10.11||0.6817|TWO_SIDED|95.0|53.0|92.0|||ANOVA|||||92.00|53.00|0.6817
71918288|NCT02483611|143358361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.19|STANDARD_DEVIATION|8.4||0.6817|TWO_SIDED|95.0|54.0|82.0|||ANOVA|||||82.00|54.00|0.6817
71918289|NCT02483611|143358361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.13|STANDARD_DEVIATION|10.5||0.6817|TWO_SIDED|95.0|47.0|81.0|||ANOVA|||||81.00|47.00|0.6817
71918290|NCT02483611|143358362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0937|TWO_SIDED|95.0|58.0|80.0|||Kruskal-Wallis|||||80.00|58.00|0.0937
71918291|NCT02483611|143358362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.5||||0.0937|TWO_SIDED|95.0|56.0|90.0|||Kruskal-Wallis|||||90.00|56.00|0.0937
71685119|NCT03003000|142888896|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.3446|TWO_SIDED|95.0|-0.168|0.48||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeated Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline placebo. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with placebo.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix.|0.480|-0.168|0.3446
71685120|NCT03003000|142888896|SUPERIORITY||Mean Difference (Final Values)|-0.129||||0.3358|TWO_SIDED|95.0|-0.392|0.134||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline ibuprofen. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with ibuprofen.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix|0.134|-0.392|0.3358
71685121|NCT03003000|142888897|SUPERIORITY||Mean Difference (Final Values)|-0.288||||0.0474|TWO_SIDED|95.0|-0.572|-0.003||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.003|-0.572|0.0474
71685122|NCT03003000|142888897|SUPERIORITY||Mean Difference (Final Values)|0.051||||0.6658|TWO_SIDED|95.0|-0.18|0.282||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine.|||0.282|-0.180|0.6658
71877698|NCT04667377|143274564|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 10% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|14.5|||<|0.0001|TWO_SIDED|95.0|5.91|35.55||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||35.55|5.91|<.0001
71877699|NCT04667377|143274565|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|2.13||||0.2654|TWO_SIDED|95.0|0.56|8.02||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||8.02|0.56|0.2654
71918292|NCT02483611|143358362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.0937|TWO_SIDED|95.0|58.0|87.0|||Kruskal-Wallis|||||87.00|58.00|0.0937
71918293|NCT02483611|143358363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.1406|TWO_SIDED|95.0|60.0|88.0|||Kruskal-Wallis|||||88.00|60.00|0.1406
71918294|NCT02483611|143358363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.5||||0.1406|TWO_SIDED|95.0|55.0|86.0|||Kruskal-Wallis|||||86.00|55.00|0.1406
71918295|NCT02483611|143358363|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.1406|TWO_SIDED|95.0|55.0|84.0|||Kruskal-Wallis|||||84.00|55.00|0.1406
71918296|NCT02483611|143358364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.25|STANDARD_DEVIATION|6.74||0.0504|TWO_SIDED|95.0|60.0|81.0|||ANOVA|||||81.00|60.00|0.0504
71918297|NCT02483611|143358364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|63.0|STANDARD_DEVIATION|7.62||0.0504|TWO_SIDED|95.0|49.0|79.0|||ANOVA|||||79.00|49.00|0.0504
71918298|NCT02483611|143358364|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|69.0|STANDARD_DEVIATION|7.56||0.0504|TWO_SIDED|95.0|58.0|84.0|||ANOVA|||||84.00|58.00|0.0504
71918299|NCT02483611|143358365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.0205|TWO_SIDED|95.0|60.0|93.0|||Kruskal-Wallis|||||93.00|60.00|0.0205
71918300|NCT02483611|143358365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|62.0||||0.0205|TWO_SIDED|95.0|54.0|72.0|||Kruskal-Wallis|||||72.00|54.00|0.0205
71918301|NCT02483611|143358365|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.0205|TWO_SIDED|95.0|59.0|75.0|||Kruskal-Wallis|||||75.00|59.00|0.0205
71918302|NCT02483611|143358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|68.0||||0.3004|TWO_SIDED|95.0|58.0|86.0|||Kruskal-Wallis|||||86.00|58.00|0.3004
71918303|NCT02483611|143358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.3004|TWO_SIDED|95.0|56.0|78.0|||Kruskal-Wallis|||||78.00|56.00|0.3004
71918304|NCT02483611|143358366|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|69.0||||0.3004|TWO_SIDED|95.0|62.0|81.0|||Kruskal-Wallis|||||81.00|62.00|0.3004
71918305|NCT02483611|143358367|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.0||||0.0178|TWO_SIDED|95.0|60.0|84.0|||Kruskal-Wallis|||||84.00|60.00|0.0178
71918306|NCT02483611|143358367|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|64.5||||0.0178|TWO_SIDED|95.0|51.0|75.0|||Kruskal-Wallis|||||75.00|51.00|0.0178
71918307|NCT02483611|143358367|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|72.0||||0.0178|TWO_SIDED|95.0|61.0|91.0|||Kruskal-Wallis|||||91.00|61.00|0.0178
71918308|NCT02483611|143358368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.67|STANDARD_DEVIATION|8.51||0.8746|TWO_SIDED|95.0|51.0|99.0|||ANOVA|||||99.00|51.00|0.8746
71918309|NCT02483611|143358368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.38|STANDARD_DEVIATION|6.96||0.8746|TWO_SIDED|95.0|56.0|82.0|||ANOVA|||||82.00|56.00|0.8746
71918310|NCT02483611|143358368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.4|STANDARD_DEVIATION|7.94||0.8746|TWO_SIDED|95.0|54.0|80.0|||ANOVA|||||80.00|54.00|0.8746
71918311|NCT02483611|143358369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|67.44|STANDARD_DEVIATION|10.95||0.4195|TWO_SIDED|95.0|47.0|92.0|||ANOVA|||||92.00|47.00|0.4195
71918312|NCT02483611|143358369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|68.38|STANDARD_DEVIATION|9.28||0.4195|TWO_SIDED|95.0|53.0|80.0|||ANOVA|||||80.00|53.00|0.4195
71918313|NCT02483611|143358369|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|64.0|STANDARD_DEVIATION|8.23||0.4195|TWO_SIDED|95.0|52.0|80.0|||ANOVA|||||80.00|52.00|0.4195
71918314|NCT02483611|143358370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|11.52||0.5796|TWO_SIDED|95.0|47.0|93.0|||ANOVA|||||93.00|47.00|0.5796
71918315|NCT02483611|143358370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.75|STANDARD_DEVIATION|10.19||0.5796|TWO_SIDED|95.0|48.0|79.0|||ANOVA|||||79.00|48.00|0.5796
71918316|NCT02483611|143358370|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|62.33|STANDARD_DEVIATION|9.26||0.5796|TWO_SIDED|95.0|50.0|79.0|||ANOVA|||||79.00|50.00|0.5796
71918317|NCT02483611|143358371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.19|STANDARD_DEVIATION|12.82||0.5351|TWO_SIDED|95.0|45.0|92.0|||ANOVA|||||92.00|45.00|0.5351
71918318|NCT02483611|143358371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|65.31|STANDARD_DEVIATION|10.87||0.5351|TWO_SIDED|95.0|47.0|82.0|||ANOVA|||||82.00|47.00|0.5351
71918319|NCT02483611|143358371|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|61.93|STANDARD_DEVIATION|9.0||0.5351|TWO_SIDED|95.0|51.0|79.0|||ANOVA|||||79.00|51.00|0.5351
71918320|NCT02483611|143358372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.5||||0.4988|TWO_SIDED|95.0|42.0|92.0|||Kruskal-Wallis|||||92.00|42.00|0.4988
71918321|NCT02483611|143358372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|63.0||||0.4988|TWO_SIDED|95.0|50.0|85.0|||Kruskal-Wallis|||||85.00|50.00|0.4988
71918322|NCT02483611|143358372|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|58.0||||0.4988|TWO_SIDED|95.0|51.0|80.0|||Kruskal-Wallis|||||80.00|51.00|0.4988
71918323|NCT02483611|143358373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|66.0||||0.7723|TWO_SIDED|95.0|43.0|89.0|||Kruskal-Wallis|||||89.00|43.00|0.7723
71918324|NCT02483611|143358373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|51.0|82.0|||Kruskal-Wallis|||||82.00|51.00|0.7723
71918325|NCT02483611|143358373|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|61.0||||0.7723|TWO_SIDED|95.0|50.0|78.0|||Kruskal-Wallis|||||78.00|50.00|0.7723
71918326|NCT00286156|143358461|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Pairwise comparisons adjusted for multiple testing (Tukey)|ANOVA|||Null hypothesis: no difference between groups in iGFR||||<0.01
71918327|NCT02449915|143358467|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||||||0.52
71918328|NCT05325333|143358485|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with DLD||||||0.567|||||||LSD test|||||||0.567
71918329|NCT05325333|143358485|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at 5 mins for children with TD||||||0.003|||||||LSD test|||||||0.003
71918330|NCT05325333|143358486|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with DLD||||||0.187|||||||LSD test|||||||0.187
71918331|NCT05325333|143358486|SUPERIORITY|Word form recall accuracy (number of words correctly recalled) on Expanding and Standard retrieval schedules at one week for children with TD||||||0.256|||||||LSD test|||||||0.256
71918332|NCT05325333|143358487|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for DLD||||||0.747|||||||LSD test|||||||0.747
71918333|NCT05325333|143358487|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at 5 Mins for TD||||||0.031|||||||LSD test|||||||0.031
71918334|NCT05325333|143358488|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for DLD||||||0.061|||||||LSD test|||||||0.061
71918335|NCT05325333|143358488|SUPERIORITY|Word meaning recall accuracy (number of semantic associations correctly recalled) on Expanding and Standard Retrieval Schedules at one week for TD||||||0.747|||||||LSD test|||||||0.747
71685123|NCT03003000|142888898|SUPERIORITY||Mean Difference (Final Values)|-0.399||||0.0091|TWO_SIDED|95.0|-0.698|-0.1||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine|||-0.100|-0.698|0.0091
71918336|NCT05325333|143358489|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for DLD||||||0.026|||||||LSD test|||||||0.026
71918337|NCT05325333|143358489|SUPERIORITY|Word recognition (number of words accurately identified) on Expanding condition and Standard Retrieval Schedules for TD||||||0.72|||||||LSD test|||||||0.720
71918338|NCT05325333|143358490|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<.0001
71918339|NCT05325333|143358491|SUPERIORITY|||||||0.673|||||||t-test, 2 sided|||||||0.673
71918340|NCT01855919|143358492|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0026|TWO_SIDED|95.0|-0.77|-0.16|||Mixed Models Analysis|||||-0.16|-0.77|0.0026
71918341|NCT01855919|143358493|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0026|TWO_SIDED|95.0|-0.48|-0.1|||Mixed Models Analysis|||||-0.10|-0.48|0.0026
71918342|NCT01855919|143358494|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0439|TWO_SIDED|95.0|-1.25|-0.02|||ANCOVA|||||-0.02|-1.25|0.0439
71918343|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.3||||0.101|TWO_SIDED|95.0|-0.66|0.06||p-value is for worst pain|Mixed Models Analysis|||||0.06|-0.66|0.1010
71918344|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0009|TWO_SIDED|95.0|-0.79|-0.21||p-value is for least pain|Mixed Models Analysis|||||-0.21|-0.79|0.0009
71918345|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.023|TWO_SIDED|95.0|-0.74|-0.05||p-value is for Pain Right Now|Mixed Models Analysis|||||-0.05|-0.74|0.0230
71918346|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0874|TWO_SIDED|95.0|-0.66|0.05||p-value is for General Activity|Mixed Models Analysis|||||0.05|-0.66|0.0874
71918347|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0436|TWO_SIDED|95.0|-0.63|-0.01||p-value is for Mood|Mixed Models Analysis|||||-0.01|-0.63|0.0436
71918348|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.3902|TWO_SIDED|95.0|-0.45|0.18||p-value is for Walking Ability|Mixed Models Analysis|||||0.18|-0.45|0.3902
71918349|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.33|0.33||p-value is for Normal Work|Mixed Models Analysis|||||0.33|-0.33|0.9910
71918350|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7848|TWO_SIDED|95.0|-0.3|0.23||p-value is for Relationship People|Mixed Models Analysis|||||0.23|-0.30|0.7848
71918351|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9424|TWO_SIDED|95.0|-0.32|0.3||p-value is for Sleep|Mixed Models Analysis|||||0.30|-0.32|0.9424
71918352|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7932|TWO_SIDED|95.0|-0.35|0.27||p-value is for Enjoyment of Life|Mixed Models Analysis|||||0.27|-0.35|0.7932
71918353|NCT01855919|143358495|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.3761|TWO_SIDED|95.0|-0.4|0.15||p-value is for Average of 7 Items|Mixed Models Analysis|||||0.15|-0.40|0.3761
71918354|NCT01855919|143358496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0049|TWO_SIDED|95.0|-0.71|-0.13||p-value is for Average Pain|Mixed Models Analysis|||||-0.13|-0.71|0.0049
71918355|NCT01855919|143358496|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0442|TWO_SIDED|95.0|-0.69|-0.01||p-value is for Worst pain|Mixed Models Analysis|||||-0.01|-0.69|0.0442
71918356|NCT01855919|143358497|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.31||||0.0003|TWO_SIDED|95.0|1.13|1.53||p-value is for ≥30%|Mantel Haenszel|||||1.53|1.13|0.0003
71918357|NCT01855919|143358497|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43||||0.0003|TWO_SIDED|95.0|1.18|1.75||p-value is for ≥50%|Mantel Haenszel|||||1.75|1.18|0.0003
71918358|NCT01855919|143358498|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.33||||0.0012|TWO_SIDED|95.0|1.12|1.58|||Mantel Haenszel|||||1.58|1.12|0.0012
71918359|NCT01855919|143358499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0019|TWO_SIDED|95.0|-0.46|-0.1|||Mixed Models Analysis|||||-0.10|-0.46|0.0019
71918360|NCT01855919|143358500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.3012|TWO_SIDED|95.0|-1.03|0.32|||ANCOVA|||||0.32|-1.03|0.3012
71918361|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.27||||0.2581|TWO_SIDED|95.0|-0.93|3.47||p-value for Physical Functioning|ANCOVA|||||3.47|-0.93|0.2581
71918362|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.58||||0.7208|TWO_SIDED|95.0|-2.62|3.79||p-value for Role (Physical)|ANCOVA|||||3.79|-2.62|0.7208
71918363|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.55||||0.2487|TWO_SIDED|95.0|-1.09|4.19||p-value for Bodily Pain|ANCOVA|||||4.19|-1.09|0.2487
71918364|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.0151|TWO_SIDED|95.0|0.57|5.31||p-value for General Health|ANCOVA|||||5.31|0.57|0.0151
71918365|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.4|TWO_SIDED|95.0|-1.54|3.85||p-value for Vitality|ANCOVA|||||3.85|-1.54|0.4000
71918366|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.2529|TWO_SIDED|95.0|-1.17|4.43||p-value for Social Functioning|ANCOVA|||||4.43|-1.17|0.2529
71918367|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.8042|TWO_SIDED|95.0|-3.55|2.75||p-value for Role(Emotional)|ANCOVA|||||2.75|-3.55|0.8042
71918368|NCT01855919|143358501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21||||0.0058|TWO_SIDED|95.0|0.94|5.48||p-value is for Mental Health|ANCOVA|||||5.48|0.94|0.0058
71918369|NCT01855919|143358502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.5237|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA|||||0.03|-0.02|0.5237
71918370|NCT01855919|143358503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.046|TWO_SIDED|95.0|-0.05|0.0||p-value for Work time missed|ANCOVA|||||0.00|-0.05|0.0460
71918371|NCT01855919|143358503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0753|TWO_SIDED|95.0|-0.08|0.0||p-value for Impairment at work|ANCOVA|||||0.00|-0.08|0.0753
71882623|NCT02706873|143284638|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|LS Mean Difference|-0.59|||<|0.001|TWO_SIDED|95.0|-0.91|-0.27||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.||-0.27|-0.91|<0.001
71918372|NCT01855919|143358503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.0795|TWO_SIDED|95.0|-0.08|0.0||p-value for Work productivity loss|ANCOVA|||||0.00|-0.08|0.0795
71918373|NCT01855919|143358503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.1466|TWO_SIDED|95.0|-0.06|0.01||p-value for Work activity impairment|ANCOVA|||||0.01|-0.06|0.1466
71918374|NCT03455530|143358511|SUPERIORITY||Mean Difference (Final Values)|0.73|||||TWO_SIDED|95.0|0.45|1.19|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||1.19|0.45|
71918375|NCT03455530|143358511|SUPERIORITY||Mean Difference (Final Values)|1.34|||||TWO_SIDED|95.0|0.55|3.24|||Mixed Models Analysis||Ratio based on the mean difference from the log scale.|||3.24|0.55|
71918376|NCT00740116|143358516|SUPERIORITY|||||||0.03||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.03
71918377|NCT00740116|143358517|SUPERIORITY|||||||0.07||||||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||||0.07
71918378|NCT00740116|143358518|SUPERIORITY||Odds Ratio (OR)|0.44||||0.46|ONE_SIDED|95.0||0.97||Statistical significance threshold was p \< 0.05|Wilcoxon (Mann-Whitney)|Mann-Whitney U-test, one-sided test||||0.97||0.46
71918379|NCT00740116|143358519|SUPERIORITY|||||||0.46||||||p\< 0.05 for statistical significance|Wilcoxon (Mann-Whitney)|||||||0.46
71918380|NCT00740116|143358520|SUPERIORITY||Odds Ratio (OR)|0.36||||0.22|TWO_SIDED|95.0|0.05|2.72||Statistical significance threshold p-value \< 0.05|Fisher Exact|||||2.72|0.05|0.22
71918381|NCT00121485|143358522|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.|Mean Difference (Final Values)|35.7||||2.5e-07|TWO_SIDED|95.0|24.5|46.9||Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O'Brien-Fleming spending function.|Fisher Exact|||Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVE||46.9|24.5|0.00000025
71918382|NCT01111331|143358537|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean ratio|100.89|STANDARD_DEVIATION|7.0|||TWO_SIDED|90.0|96.86|105.1|||ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by empa||105.10|96.86|
71918383|NCT01111331|143358538|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|100.64|STANDARD_DEVIATION|19.9||0.0021|TWO_SIDED|90.0|89.79|112.8||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by empa||112.80|89.79|0.0021
71918384|NCT01111331|143358539|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.49|STANDARD_DEVIATION|5.7|||TWO_SIDED|90.0|95.29|101.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||101.80|95.29|
71918385|NCT01111331|143358540|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|97.89|STANDARD_DEVIATION|12.4||0.0001|TWO_SIDED|90.0|91.12|105.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||105.15|91.12|0.0001
71918386|NCT01111331|143358541|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|95.88|STANDARD_DEVIATION|4.5|||TWO_SIDED|90.0|93.4|98.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.43|93.40|
71918387|NCT01111331|143358542|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.88|STANDARD_DEVIATION|12.7||0.0001|TWO_SIDED|90.0|91.84|106.47||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||106.47|91.84|0.0001
71918388|NCT01111331|143358550|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.9|STANDARD_DEVIATION|5.3|||TWO_SIDED|90.0|95.89|102.0|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin||102.00|95.89|
71918389|NCT01111331|143358557|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|96.09|STANDARD_DEVIATION|4.4|||TWO_SIDED|90.0|93.64|98.6|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin||98.60|93.64|
71685124|NCT03003000|142888898|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.6387|TWO_SIDED|95.0|-0.185|0.302||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine|||0.302|-0.185|0.6387
71877700|NCT04667377|143274565|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|9.47||||0.0002|TWO_SIDED|95.0|2.89|30.95||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||30.95|2.89|0.0002
71918390|NCT01111331|143358564|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.04|0.73|
71918391|NCT01111331|143358565|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.88|||||TWO_SIDED|95.0|0.79|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.79|
71918392|NCT01111331|143358566|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.99|||||TWO_SIDED|95.0|0.67|1.48|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline INR value||Difference calculated as empa plus warfarin minus warfarin||1.48|0.67|
71918393|NCT01111331|143358567|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.9|||||TWO_SIDED|95.0|0.79|1.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.02|0.79|
71918394|NCT01111331|143358568|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.95|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.95|0.64|
71918395|NCT01111331|143358569|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.91|||||TWO_SIDED|95.0|0.84|0.98|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||0.98|0.84|
71918396|NCT01111331|143358570|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.97|||||TWO_SIDED|95.0|0.68|1.4|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.40|0.68|
71918397|NCT01111331|143358571|NON_INFERIORITY_OR_EQUIVALENCE|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.85|||||TWO_SIDED|95.0|0.47|1.51|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period, treatment and the baseline PT value||Difference calculated as empa plus warfarin minus warfarin||1.51|0.47|
71918398|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|2.9||||0.3474|TWO_SIDED|95.0|-3.3|9.1|||ANOVA|Analysis of variance for repeated measures||Dryness - Study eye - Day 15±2 The model included fixed effect terms for time point, baseline covariate (i.e. the day 1 - pre-dose value) and treatment. Time point was specified as a repeated measurement.||9.1|-3.3|0.3474
71918399|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.1327|TWO_SIDED|95.0|-8.2|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||4.3|-8.2|0.1327
71918400|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-4.8||||0.1327|TWO_SIDED|95.0|-11.2|1.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Study eye - Day 15±2||1.6|-11.2|0.1327
71918401|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.2237|TWO_SIDED|95.0|-2.5|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||10.0|-2.5|0.2237
71918402|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.4905|TWO_SIDED|95.0|-8.4|4.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||4.1|-8.4|0.4905
71918403|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-5.9||||0.0687|TWO_SIDED|95.0|-12.3|0.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Study eye - Day 15±2||0.5|-12.3|0.0687
71918404|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.7609|TWO_SIDED|95.0|-4.2|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||5.6|-4.2|0.7609
71918405|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.6428|TWO_SIDED|95.0|-6.0|3.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.8|-6.0|0.6428
71918406|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Study eye - Day 15±2||3.2|-6.9|0.4599
71918407|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.4217|TWO_SIDED|95.0|-4.6|10.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||10.5|-4.6|0.4217
71918408|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.503||||-2.5|TWO_SIDED|95.0|-10.0|5.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||5.0|-10.0|-2.5
71918409|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.4599|TWO_SIDED|95.0|-6.9|3.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Study eye - Day 15±2||3.2|-6.9|0.4599
71918410|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.6157|TWO_SIDED|95.0|-2.6|4.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||4.4|-2.6|0.6157
71918411|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.912|TWO_SIDED|95.0|-3.7|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||3.3|-3.7|0.9120
71918412|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.5463|TWO_SIDED|95.0|-4.6|2.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Study eye - Day 15±2||2.5|-4.6|0.5463
71918413|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.9065|TWO_SIDED|95.0|-5.9|5.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||5.3|-5.9|0.9065
71918414|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.8||||0.5065|TWO_SIDED|95.0|-7.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||3.7|-7.3|0.5065
71918415|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.5977|TWO_SIDED|95.0|-7.1|4.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky Feeling - Study eye - Day 15±2||4.2|-7.1|0.5977
71918416|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-2.2||||0.2785|TWO_SIDED|95.0|-6.3|1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred Vision - Study eye - Day 15±2||1.9|-6.3|0.2785
71918417|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.7454|TWO_SIDED|95.0|-4.6|3.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||3.3|-4.6|0.7454
71918418|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.4588|TWO_SIDED|95.0|-2.7|5.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Study eye - Day 15±2||5.9|-2.7|0.4588
71918419|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.2812|TWO_SIDED|95.0|-3.7|12.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||12.3|-3.7|0.2812
71918420|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.6811|TWO_SIDED|95.0|-6.5|9.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||9.8|-6.5|0.6811
71918421|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.5169|TWO_SIDED|95.0|-10.8|5.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Study eye - Day 15±2||5.6|-10.8|0.5169
71918422|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.7874|TWO_SIDED|95.0|-5.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||7.8|-5.9|0.7874
71918423|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.8299|TWO_SIDED|95.0|-7.6|6.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||6.1|-7.6|0.8299
71918424|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.6386|TWO_SIDED|95.0|-8.7|5.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Dryness - Non Study eye - Day 15±2||5.4|-8.7|0.6386
71918425|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.0132|TWO_SIDED|95.0|1.3|10.2|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||10.2|1.3|0.0132
71918426|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.7177|TWO_SIDED|95.0|-5.3|3.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||3.7|-5.3|0.7177
71918427|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.0077|TWO_SIDED|95.0|-11.2|-1.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Foreign body sensation - Non Study eye - Day 15±2||-1.9|-11.2|0.0077
71918428|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|5.3||||0.0301|TWO_SIDED|95.0|0.6|10.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||10.0|0.6|0.0301
71918429|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.8657|TWO_SIDED|95.0|-4.3|5.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||5.1|-4.3|0.8657
71918430|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-4.9||||0.044|TWO_SIDED|95.0|-9.7|-0.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Burning/Stinging - Non Study eye - Day 15±2||-0.1|-9.7|0.0440
71918431|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1351|TWO_SIDED|95.0|-1.4|9.6|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||9.6|-1.4|0.1351
71918432|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.8821|TWO_SIDED|95.0|-6.0|5.2|||ANCOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||5.2|-6.0|0.8821
71685125|NCT03003000|142888899|SUPERIORITY||Mean Difference (Final Values)|0.559||||0.4398|TWO_SIDED|95.0|-0.861|1.979||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect model for repeated measures||Adjusted mean change ibuprofen and caffeine - Adjusted mean change placebo. A negative result favors ibuprofen and caffeine.|Mixed effect model for repeated measures (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.979|-0.861|0.4398
71685126|NCT03003000|142888899|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.7911|TWO_SIDED|95.0|-1.002|1.314||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine.|MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.||1.314|-1.002|0.7911
71918433|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-4.5||||0.1208|TWO_SIDED|95.0|-10.3|1.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Itching - Non Study eye - Day 15±2||1.3|-10.3|0.1208
71918434|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.944|TWO_SIDED|95.0|-3.3|3.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||3.5|-3.3|0.9440
71918435|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.4903|TWO_SIDED|95.0|-2.2|4.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.5|-2.2|0.4903
71918436|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.5364|TWO_SIDED|95.0|-2.3|4.3|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Pain - Non Study eye - Day 15±2||4.3|-2.3|0.5364
71918437|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.51|TWO_SIDED|95.0|-2.9|5.7|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||5.7|-2.9|0.5100
71918438|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.1132|TWO_SIDED|95.0|-0.9|7.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||7.8|-0.9|0.1132
71918439|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.3457|TWO_SIDED|95.0|-2.4|6.5|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Sticky feeling - Non Study eye - Day 15±2||6.5|-2.4|0.3457
71918440|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.0185|TWO_SIDED|95.0|0.8|7.9|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.9|0.8|0.0185
71918441|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|3.6||||0.0408|TWO_SIDED|95.0|0.2|7.1|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||7.1|0.2|0.0408
71918442|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.6992|TWO_SIDED|95.0|-4.4|3.0|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Blurred vision - Non Study eye - Day 15±2||3.0|-4.4|0.6992
71918443|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|5.9||||0.0905|TWO_SIDED|95.0|-1.0|12.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||12.8|-1.0|0.0905
71685127|NCT03003000|142888900|SUPERIORITY||Odds Ratio (OR)|1.777||||0.0045|TWO_SIDED|95.0|1.195|2.642||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||2.642|1.195|0.0045
71918444|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|3.5||||0.3054|TWO_SIDED|95.0|-3.4|10.4|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||10.4|-3.4|0.3054
71918445|NCT03031327|143358575|SUPERIORITY||Mean Difference (Final Values)|0.5024||||0.5024|TWO_SIDED|95.0|-9.6|4.8|||ANOVA|||Analysis of variance on changes from baseline in ocular tolerability - Photophobia - Non Study eye - Day 15±2||4.8|-9.6|0.5024
71918446|NCT03031327|143358577|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.1226|TWO_SIDED|95.0|-0.1|0.8|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.8|-0.1|0.1226
71918447|NCT03031327|143358577|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.2854|TWO_SIDED|95.0|-0.2|0.7|||Student t-test pooled|Student t-test with pool method for estimating common variance on changes from baseline in ocular surface vital staining||Study eye - Day 15±2 pre-dose||0.7|-0.2|0.2854
71918448|NCT03031327|143358577|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.6525|TWO_SIDED|95.0|-0.6|0.4|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Student t-test on changes from baseline in ocular surface vital staining - Study eye - Day 15±2 pre-dose||0.4|-0.6|0.6525
71918449|NCT03031327|143358577|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8843|TWO_SIDED|95.0|-0.4|0.5|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining -||Non Study eye - Day 15±2 pre-dose||0.5|-0.4|0.8843
71918450|NCT03031327|143358577|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0806|TWO_SIDED|95.0|-0.6|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.6|0.0806
71918451|NCT03031327|143358577|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.0628|TWO_SIDED|95.0|-0.7|0.0|||Student t-test pooled|Student t-test pooled method for estimating common variance on changes from baseline in ocular surface vital staining||Non Study eye - Day 15±2 pre-dose||0.0|-0.7|0.0628
71918452|NCT03031327|143358578|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.2004|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.9|-0.2|0.2004
71685128|NCT03003000|142888900|SUPERIORITY||Odds Ratio (OR)|1.008||||0.9603|TWO_SIDED|95.0|0.732|1.389||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator|||1.389|0.732|0.9603
71877701|NCT04667377|143274565|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|11.79|||<|0.0001|TWO_SIDED|95.0|3.62|38.36||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||38.36|3.62|<.0001
71877702|NCT04667377|143274565|OTHER|"Missing body weight measurements were multiply imputed using MMRM with treatment, gender, baseline body weight as factors. Percentage change in body weight from baseline to Week 46 and Body weight loss ≥ 15% at Week 46 (yes/no) were derived per participant in each of the 1000 imputed datasets. Each dataset was analysed by a logistic regression. Multiple estimates from multiple imputation runs were summarised using Rubin's method."|Odds Ratio (OR)|21.02|||<|0.0001|TWO_SIDED|95.0|6.47|68.28||P-value is considered nominal.|Regression, Logistic|Logistic regression with treatment group and gender as factors and baseline body weight as a continuous linear covariate.|Odds ratio is calculated as BI 456906 / Placebo.|Logistic regression after multiple imputation. Analysis based on all available post-baseline body weight measurements (on-treatment (first intake of study drug until 28 days after last intake of study drug) and off-treatment), except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used.||68.28|6.47|<.0001
71877703|NCT04667377|143274566|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.53|STANDARD_ERROR_OF_MEAN|1.48||0.0025|TWO_SIDED|95.0|-7.44|-1.61||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-1.61|-7.44|0.0025
71877704|NCT04667377|143274566|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.07|STANDARD_ERROR_OF_MEAN|1.46|<|0.0001|TWO_SIDED|95.0|-14.94|-9.19||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-9.19|-14.94|<.0001
71877705|NCT04667377|143274566|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.96|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-15.85|-10.07||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-10.07|-15.85|<.0001
71877706|NCT04667377|143274566|OTHER|MMRM with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-15.78|STANDARD_ERROR_OF_MEAN|1.47|<|0.0001|TWO_SIDED|95.0|-18.67|-12.9||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo at week 46.|No formal hypotheses were tested.||-12.90|-18.67|<.0001
71877707|NCT04667377|143274567|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-4.36|STANDARD_ERROR_OF_MEAN|1.71||0.0116|TWO_SIDED|95.0|-7.74|-0.98||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.98|-7.74|0.0116
71877708|NCT04667377|143274567|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.03|STANDARD_ERROR_OF_MEAN|1.71|<|0.0001|TWO_SIDED|95.0|-14.39|-7.66||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.66|-14.39|<.0001
71918453|NCT03031327|143358578|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.5413|TWO_SIDED|95.0|-0.3|0.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.6|-0.3|0.5413
71918454|NCT03031327|143358578|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.4607|TWO_SIDED|95.0|-0.8|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Study eye - Day 15±2 pre-dose||0.4|-0.8|0.4607
71685129|NCT03003000|142888901|SUPERIORITY||Odds Ratio (OR)|1.028||||0.9022|TWO_SIDED|95.0|0.663|1.592||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.592|0.663|0.9022
71685130|NCT03003000|142888901|SUPERIORITY||Odds Ratio (OR)|0.834||||0.3129|TWO_SIDED|95.0|0.586|1.187||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.187|0.586|0.3129
71685131|NCT03003000|142888901|SUPERIORITY||Odds Ratio (OR)|1.354||||0.3301|TWO_SIDED|95.0|0.736|2.494||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|2.494|0.736|0.3301
71685132|NCT03003000|142888901|SUPERIORITY||Odds Ratio (OR)|0.68||||0.0864|TWO_SIDED|95.0|0.437|1.057||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio \>1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.|1.057|0.437|0.0864
71877709|NCT04667377|143274567|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-11.0|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-14.33|-7.67||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-7.67|-14.33|<.0001
71877710|NCT04667377|143274567|OTHER|MMRM with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-12.05|STANDARD_ERROR_OF_MEAN|1.69|<|0.0001|TWO_SIDED|95.0|-15.39|-8.71||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-8.71|-15.39|<.0001
71918455|NCT03031327|143358578|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1248|TWO_SIDED|95.0|-0.2|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.4|-0.2|0.1248
71918456|NCT03031327|143358578|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.0624|TWO_SIDED|95.0|0.0|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||1.1|0.0|0.0624
71685133|NCT03003000|142888902|SUPERIORITY|||||||0.9384||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.9384
71685134|NCT03003000|142888902|SUPERIORITY|||||||0.3534||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test||||||0.3534
71685135|NCT03743402|142888903|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in MME/day between arms.|Mean Difference (Final Values)|-2.54||||0.58|TWO_SIDED|95.0|-10.55|5.88|||Regression, Linear||mean difference=(pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect an average 24 MME/day difference between arms.||5.88|-10.55|0.58
71685136|NCT03743402|142888904|EQUIVALENCE|The null hypothesis was a point null of exactly 0 expected difference in PEG score between arms.|Mean Difference (Final Values)|0.01||||0.98|TWO_SIDED|95.0|-0.51|0.52|||Regression, Linear||mean difference = (pain self-management)-(usual care)|A priori power calculations indicated 90% power to detect a 1.2-point average difference in PEG score between arms.||0.52|-0.51|0.98
71685137|NCT03743402|142888905|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in average MME/day between arms.|Mean Difference (Final Values)|1.3||||0.72|TWO_SIDED|95.0|-5.69|8.29|||Regression, Linear||mean difference=(pain self-management)-(usual care)|||8.29|-5.69|0.72
71685138|NCT03743402|142888906|EQUIVALENCE|The null hypothesis is a point null of exactly 0 difference in expected PEG score between arms.|Mean Difference (Final Values)|-0.53||||0.07|TWO_SIDED|95.0|-1.11|0.05|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.05|-1.11|0.07
71918457|NCT03031327|143358578|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.7927|TWO_SIDED|95.0|-1.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in Schirmer-I test - Non Study eye - Day 15±2 pre-dose||0.8|-1.0|0.7927
71685139|NCT03743402|142888907|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|2.11||||0.8|TWO_SIDED|95.0|-13.83|18.04|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||18.04|-13.83|0.80
71918458|NCT03031327|143358579|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9717|TWO_SIDED|95.0|-0.6|0.7|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.7|-0.6|0.9717
71685140|NCT03743402|142888908|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|4.33||||0.02|TWO_SIDED|95.0|0.56|8.09|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||8.09|0.56|0.02
71918459|NCT03031327|143358579|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7386|TWO_SIDED|95.0|-0.6|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Study eye - Day 15±2 pre-dose||0.9|-0.6|0.7386
71918460|NCT03031327|143358579|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.7498|TWO_SIDED|95.0|-0.6|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Study eye - Day 15±2 pre-dose||0.8|-0.6|0.7498
71918461|NCT03031327|143358579|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.3229|TWO_SIDED|95.0|-1.1|0.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.4|-1.1|0.3229
71918462|NCT03031327|143358579|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.57|TWO_SIDED|95.0|-0.5|0.9|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||0.9|-0.5|0.5700
71918463|NCT03031327|143358579|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.1197|TWO_SIDED|95.0|-0.2|1.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in TFBUT - Non Study eye - Day 15±2 pre-dose||1.3|-0.2|0.1197
71918464|NCT03031327|143358580|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.8787|TWO_SIDED|95.0|-0.6|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.6|0.8787
71918465|NCT03031327|143358580|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8159|TWO_SIDED|95.0|-0.5|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.7|-0.5|0.8159
71918466|NCT03031327|143358580|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.6525|TWO_SIDED|95.0|-0.4|0.6|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Study eye - Day 15±2 pre-dose||0.6|-0.4|0.6525
71918467|NCT03031327|143358580|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.334|TWO_SIDED|95.0|-1.0|0.4|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.4|-1.0|0.3340
71918468|NCT03031327|143358580|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.9749|TWO_SIDED|95.0|-0.7|0.7|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.7|-0.7|0.9749
71918469|NCT03031327|143358580|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.1984|TWO_SIDED|95.0|-0.2|0.9|||Student t-test pooled|||Student t-test on changes from baseline in BCDVA - Non Study eye - Day 15±2 pre-dose||0.9|-0.2|0.1984
71918470|NCT03031327|143358581|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.6497|TWO_SIDED|95.0|-10.5|16.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||16.4|-10.5|0.6497
71918471|NCT03031327|143358581|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.1443|TWO_SIDED|95.0|-16.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||2.6|-16.5|0.1443
71918472|NCT03031327|143358581|SUPERIORITY||Mean Difference (Final Values)|-9.9||||0.0751|TWO_SIDED|95.0|-20.9|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Frequency of symptoms - Day 15±2 pre-dose||1.1|-20.9|0.0751
71685141|NCT03743402|142888909|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.35||||0.75|TWO_SIDED|95.0|-2.53|1.82|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.82|-2.53|0.75
71918473|NCT03031327|143358581|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.5015|TWO_SIDED|95.0|-7.9|15.5|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||15.5|-7.9|0.5015
71918474|NCT03031327|143358581|SUPERIORITY||Mean Difference (Final Values)|-4.1||||0.3217|TWO_SIDED|95.0|-12.5|4.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||4.4|-12.5|0.3217
71685142|NCT03743402|142888910|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PHQ-8 score between arms.|Mean Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.87|0.87|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.87|-1.87|0.48
71918475|NCT03031327|143358581|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.1026|TWO_SIDED|95.0|-17.5|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in SANDE scores - Severity of symptoms - Day 15±2 pre-dose||1.8|-17.5|0.1026
71918476|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
71918477|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
71918478|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Study eye - Day 15±2 pre-dose||||1.000
71918479|NCT03031327|143358582|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
71918480|NCT03031327|143358582|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||0.4101
71918481|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Meibomian Glands - Non Study eye - Day 15±2 pre-dose||||1.000
71918482|NCT03031327|143358582|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
71918483|NCT03031327|143358582|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||0.4101
71918484|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Study eye - Day 15±2 pre-dose||||1.000
71918485|NCT03031327|143358582|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
71918486|NCT03031327|143358582|SUPERIORITY|||||||0.4101|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||0.4101
71918487|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Erythema - Non Study eye - Day 15±2 pre-dose||||1.000
71918488|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71918489|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71918490|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71918491|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71918492|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71918493|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Eyelid - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71918494|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
71918495|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
71918496|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Study eye - Day 15±2 pre-dose||||1.000
71918497|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
71918498|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
71918499|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lashes - Non Study eye - Day 15±2 pre-dose||||1.000
71918500|NCT03031327|143358582|SUPERIORITY|||||||0.5267|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.5267
71918501|NCT03031327|143358582|SUPERIORITY|||||||0.2633|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.2633
71918502|NCT03031327|143358582|SUPERIORITY|||||||0.6552|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Study eye - Day 15±2 pre-dose||||0.6552
71918503|NCT03031327|143358582|SUPERIORITY|||||||0.1262|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.1262
71918504|NCT03031327|143358582|SUPERIORITY|||||||0.2094|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||||0.2094
71918505|NCT03031327|143358582|SUPERIORITY||Hodges Lehmann estimation|-1.0||||0.0377|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Erythema - Non Study eye - Day 15±2 pre-dose||0.0|-1.0|0.0377
71918506|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71918507|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71918508|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Study eye - Day 15±2 pre-dose||||1.000
71918509|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71918510|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71918511|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Conjunctiva - Oedema - Non Study eye - Day 15±2 pre-dose||||1.000
71918512|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
71918513|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
71918514|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Study eye - Day 15±2 pre-dose||||1.000
71685143|NCT03743402|142888911|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|-0.25||||0.64|TWO_SIDED|95.0|-1.31|0.81|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.81|-1.31|0.64
71685144|NCT03743402|142888912|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in GAD-7 score between arms.|Mean Difference (Final Values)|0.28||||0.65|TWO_SIDED|95.0|-0.94|1.51|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.51|-0.94|0.65
71918515|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
71918516|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
71918517|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Lens - Non Study eye - Day 15±2 pre-dose||||1.000
71918518|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
71918519|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
71918520|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Study eye - Day 15±2 pre-dose||||1.000
71918521|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
71918522|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
71918523|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Iris - Non Study eye - Day 15±2 pre-dose||||1.000
71918524|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
71918525|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
71918526|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Study eye - Day 15±2 pre-dose||||1.000
71918527|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
71918528|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
71918529|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Anterior chamber inflammation - Non Study eye - Day 15±2 pre-dose||||1.000
71918530|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
71918531|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
71918532|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Study eye - Day 15±2 pre-dose||||1.000
71918533|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
71685145|NCT03743402|142888913|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|0.61||||0.02|TWO_SIDED|95.0|0.12|1.1|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.10|0.12|0.02
71918534|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
71918535|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea transparency - Non Study eye - Day 15±2 pre-dose||||1.000
71918536|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
71918537|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
71918538|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Study eye - Day 15±2 pre-dose||||1.000
71918539|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
71918540|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
71918541|NCT03031327|143358582|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum Test on changes from baseline in SLE examination scores - Cornea neovascularization - Non Study eye - Day 15±2 pre-dose||||1.000
71918542|NCT03031327|143358583|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5842|TWO_SIDED|95.0|-1.5|2.6|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||2.6|-1.5|0.5842
71685146|NCT03743402|142888914|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PGIC score between arms.|Mean Difference (Final Values)|1.33|||<|0.01|TWO_SIDED|95.0|0.77|1.88|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||1.88|0.77|<0.01
71877711|NCT04667377|143274568|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-3.73|STANDARD_ERROR_OF_MEAN|2.08||0.0733|TWO_SIDED|95.0|-7.82|0.35||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||0.35|-7.82|0.0733
71877712|NCT04667377|143274568|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-5.62|STANDARD_ERROR_OF_MEAN|2.08|<|0.0072|TWO_SIDED|95.0|-9.71|1.53||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.53|-9.71|<.0072
71877713|NCT04667377|143274568|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.2|STANDARD_ERROR_OF_MEAN|2.05||0.0027|TWO_SIDED|95.0|-10.23|-2.17||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.17|-10.23|0.0027
71877714|NCT04667377|143274568|OTHER|MMRM with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-6.16|STANDARD_ERROR_OF_MEAN|2.08||0.0033|TWO_SIDED|95.0|-10.25|-2.06||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-2.06|-10.25|0.0033
71877715|NCT04667377|143274569|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-1.44|STANDARD_ERROR_OF_MEAN|1.26||0.2569|TWO_SIDED|95.0|-3.92|1.05||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||1.05|-3.92|0.2569
71877716|NCT04667377|143274569|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.49|STANDARD_ERROR_OF_MEAN|1.26||0.0495|TWO_SIDED|95.0|-4.97|0.0||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.00|-4.97|0.0495
71877717|NCT04667377|143274569|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.44|STANDARD_ERROR_OF_MEAN|1.24||0.0506|TWO_SIDED|95.0|-4.9|0.01||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 -placebo.|No formal hypotheses were tested.||0.01|-4.90|0.0506
71877718|NCT04667377|143274569|OTHER|MMRM with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit as repeated measures and an unstructured covariance matrix to model within subject measurements.|Difference of adjusted means|-2.93|STANDARD_ERROR_OF_MEAN|1.25||0.0202|TWO_SIDED|95.0|-5.4|-0.46||P-value is considered nominal.|Mixed Models Analysis|Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|Difference was calculated as BI 456906 - placebo.|No formal hypotheses were tested.||-0.46|-5.40|0.0202
71877719|NCT01011439|143274570|SUPERIORITY||Single proportion|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.59|||Fisher Exact|||H0:p\</=17% vs. H1:p\>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients' enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.||0.59|0.31|<0.001
71877720|NCT02606461|143274621|SUPERIORITY||Hazard Ratio (HR)|0.7026||||0.0114|TWO_SIDED|95.0|0.5191|0.9509|||Log Rank|||||0.9509|0.5191|0.0114
71877721|NCT02606461|143274623|SUPERIORITY||Hazard Ratio, log|1.1521||||0.6051|TWO_SIDED|95.0|0.5357|2.4778|||Log Rank|||||2.4778|0.5357|0.6051
71685147|NCT03743402|142888915|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.09||||0.42|TWO_SIDED|95.0|-0.13|0.31|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.31|-0.13|0.42
71918543|NCT03031327|143358583|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4606|TWO_SIDED|95.0|-2.2|1.0|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||1.0|-2.2|0.4606
71685148|NCT03743402|142888916|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in POMI score between arms.|Mean Difference (Final Values)|0.13||||0.26|TWO_SIDED|95.0|-0.1|0.36|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.36|-0.10|0.26
71685149|NCT03743402|142888917|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|1.6||||0.54|TWO_SIDED|95.0|-3.47|6.66|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||6.66|-3.47|0.54
71685150|NCT03743402|142888918|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PODS score between arms.|Mean Difference (Final Values)|0.48||||0.59|TWO_SIDED|95.0|-1.26|2.21|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||2.21|-1.26|0.59
71685151|NCT03743402|142888919|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in opioid craving score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.66|0.57|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.57|-0.66|0.90
71918544|NCT03031327|143358583|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.2319|TWO_SIDED|95.0|-3.0|0.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Study eye - Day 15±2 pre-dose||0.8|-3.0|0.2319
71918545|NCT03031327|143358583|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.6018|TWO_SIDED|95.0|-2.3|1.4|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.4|-2.3|0.6018
71918546|NCT03031327|143358583|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.4857|TWO_SIDED|95.0|-2.2|1.1|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.1|-2.2|0.4857
71918547|NCT03031327|143358583|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.9015|TWO_SIDED|95.0|-2.0|1.8|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in IOP - Non Study eye - Day 15±2 pre-dose||1.8|-2.0|0.9015
71918548|NCT03031327|143358584|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
71918549|NCT03031327|143358584|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.3574|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.3|-0.1|0.3574
71918550|NCT03031327|143358584|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Study eye - Day 15±2 pre-dose||0.0|0.0|00
71918551|NCT03031327|143358584|SUPERIORITY||Mean Difference (Final Values)|0.0||||0|TWO_SIDED|95.0|0.0|0.0||P-value is NA due to the measured values of corneal sensitivity equal to zero.|Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.0|0.0|00
71685152|NCT03743402|142888920|EQUIVALENCE|The null hypothesis is a point null of exactly 0 expected difference in PSEQ score between arms.|Mean Difference (Final Values)|-0.35||||0.3|TWO_SIDED|95.0|-1.03|0.32|||Regression, Linear||mean difference = (pain self-management) - (usual care)|||0.32|-1.03|0.30
71685153|NCT03743402|142888921|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|2.1||||0.2|TWO_SIDED|95.0|0.68|6.53|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||6.53|0.68|0.20
71877722|NCT03496324|143274647|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% confidence interval (CI) (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|94.19|STANDARD_ERROR_OF_MEAN|18.9|||TWO_SIDED|90.0|85.81|103.38||||||||103.38|85.81|
71877723|NCT03496324|143274647|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|111.66|STANDARD_ERROR_OF_MEAN|14.3|||TWO_SIDED|90.0|103.84|120.07||||||||120.07|103.84|
71877724|NCT03496324|143274648|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|101.57|STANDARD_ERROR_OF_MEAN|10.5|||TWO_SIDED|90.0|96.28|107.16||||||||107.16|96.28|
71877725|NCT03496324|143274648|EQUIVALENCE|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|104.47|STANDARD_ERROR_OF_MEAN|6.0|||TWO_SIDED|90.0|101.4|107.63||||||||107.63|101.4|
71877726|NCT02092350|143274655|SUPERIORITY_OR_OTHER|||||||0.001|||||||One-sided exact test|||The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be \>45%.||||0.001
71877727|NCT00239226|143274660|SUPERIORITY_OR_OTHER||Slope|3.93||||0.047|||||||Log Rank|||||||0.047
71877728|NCT00646906|143274676|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize the effects of aspirin, while reversing the order of administration will not. Percent change from start (8:00 am on day 1) to finish (8:00 am on day 7) of period in serum thromboxane B2 for each order of drug administration will be primary endpoint of interest.||||>0.05
71877729|NCT00646906|143274677|SUPERIORITY|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||||||>0.05
71877730|NCT00240981|143274698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.8||||0.003|TWO_SIDED|95.0|43.9|215.6||The unadjusted analysis using two-sample Student's t-tests of equal change in the trial groups, allowing unequal variance.|t-test, 2 sided|||||215.6|43.9|0.003
71877731|NCT00240981|143274698|SUPERIORITY_OR_OTHER||Mean Difference (Net)|129.4||||0.004|TWO_SIDED|95.0|43.5|215.4||Adjusted analysis used multiple linear regression, with adjustment for baseline total score on the Short Physical Performance Battery, and self-report of limitations in mobility.|Regression, Linear|||||215.4|43.5|0.004
71877732|NCT00240981|143274699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.2|55.8||Unadjusted|t-test, 2 sided|||||55.8|13.2|0.002
71877733|NCT00240981|143274699|SUPERIORITY_OR_OTHER||Mean Difference (Net)|34.5||||0.002|TWO_SIDED|95.0|13.1|56.2||Adjusted|Regression, Linear|||||56.2|13.1|0.002
71877734|NCT00240981|143274700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.7||||0.34|TWO_SIDED|95.0|-9.2|26.7||Unadjusted|t-test, 2 sided|||||26.7|-9.2|0.34
71877735|NCT00240981|143274700|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.1||||0.37|TWO_SIDED|95.0|-9.9|26.2||Adjusted.|Regression, Linear|||||26.2|-9.9|0.37
71877736|NCT00240981|143274701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27||||0.69|TWO_SIDED|95.0|-1.1|1.7||Unadjusted|t-test, 2 sided|||||1.7|-1.1|0.69
71877737|NCT00240981|143274701|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.26||||0.71|TWO_SIDED|95.0|-1.1|1.7||Adjusted.|Regression, Linear|||||1.7|-1.1|0.71
71918552|NCT03031327|143358584|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
71877738|NCT00240981|143274702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.26|TWO_SIDED|95.0|-0.035|0.135||Unadjusted.|t-test, 2 sided|||||0.135|-0.035|0.26
71877739|NCT00240981|143274702|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.048||||0.27|TWO_SIDED|95.0|-0.037|0.133||Adjusted|Regression, Linear|||||0.133|-0.037|0.27
71877740|NCT00240981|143274703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|30.2||||0.05|TWO_SIDED|95.0|0.3|60.1||Unadjusted.|t-test, 2 sided|||||60.1|0.3|0.05
71877741|NCT00240981|143274703|SUPERIORITY_OR_OTHER||Mean Difference (Net)|29.7||||0.05|TWO_SIDED|95.0|0.2|59.3||Adjusted|Regression, Linear|||||59.3|0.2|0.05
71877742|NCT00240981|143274705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.2|TWO_SIDED|95.0|1.2|2.5||Month 3 Measures|t-test, 2 sided|||||2.5|1.2|0.2
71877743|NCT00240981|143274705|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.5|||<|0.0001|TWO_SIDED|95.0|0.4|2.2||Month 6 Measures|t-test, 2 sided|||||2.2|0.4|<.0001
71877744|NCT00240981|143274706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.002|TWO_SIDED|95.0|-2.7|-0.6||3 Months Measures|t-test, 2 sided|||||-0.6|-2.7|0.002
71877745|NCT00240981|143274706|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|||<|0.0001|TWO_SIDED|95.0|-2.8|-1.2||6 Month Measures|t-test, 2 sided|||||-1.2|-2.8|<.0001
71877746|NCT00240981|143274707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074||||0.24|TWO_SIDED|95.0|-0.05|0.19||Unadjusted.|t-test, 2 sided|||||0.19|-0.05|0.24
71877747|NCT00240981|143274707|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.14|TWO_SIDED|95.0|-0.03|0.209||Adjusted.|Regression, Linear|||||0.209|-0.030|0.14
71877748|NCT00766090|143274713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108|||<|0.001|TWO_SIDED|95.0|0.064|0.153|||ANCOVA|||||0.153|0.064|<0.001
71877749|NCT00766090|143274713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|||<|0.001|TWO_SIDED|95.0|0.054|0.142|||ANCOVA|||||0.142|0.054|<0.001
71877750|NCT00766090|143274713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087||||0.02|TWO_SIDED|95.0|0.014|0.161|||ANCOVA|||||0.161|0.014|0.020
71877751|NCT00766090|143274713|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters.|Mean Difference (Final Values)|0.011||||0.641|TWO_SIDED|95.0|-0.035|0.056|||ANCOVA|||||0.056|-0.035|0.641
71877752|NCT00766090|143274713|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|||<|0.001|TWO_SIDED|95.0|0.059|0.205|||ANCOVA|||||0.205|0.059|<0.001
71685154|NCT03743402|142888922|EQUIVALENCE|The null hypothesis is a point null of the relative risk of 30% reduction from baseline equal exactly to 1.|Risk Ratio (RR)|1.34||||0.53|TWO_SIDED|95.0|0.54|3.32|||Regression, Poison||relative risk = (pain self-management)/(usual care)|||3.32|0.54|0.53
71685155|NCT02191046|142888923|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Final Values)|4.38|STANDARD_DEVIATION|2.89|<|0.05|TWO_SIDED|95.0|3.41|5.37|||t-test, 2 sided|||compare the mean 5S-score between before and after treatment in syringe group||5.37|3.41|<0.05
71685156|NCT02191046|142888923|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|0.93|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED|95.0|0.094|1.76|||t-test, 2 sided|||compare the mean 5S-score between 2 groups at 2 weeks after treatment||1.76|0.094|<0.05
71685157|NCT02191046|142888923|NON_INFERIORITY_OR_EQUIVALENCE|power of study = 90%|Mean Difference (Net)|-0.47|STANDARD_DEVIATION|0.17|<|0.05|TWO_SIDED|95.0|-0.82|-0.12|||t-test, 2 sided|||satisfaction score between two groups at 2 weeks after treatment||-0.12|-0.82|<0.05
71877753|NCT02871778|143274729|SUPERIORITY||Least Square (LS) Mean difference|1.519||||0.0437|TWO_SIDED|95.0|0.044|2.995|||Mixed-effects Model|||||2.995|0.044|0.0437
71877754|NCT02871778|143274729|SUPERIORITY||LS Mean difference|0.04||||0.9755|TWO_SIDED|95.0|-2.509|2.589|||Mixed-effects Model|||||2.589|-2.509|0.9755
71877755|NCT02871778|143274729|SUPERIORITY||LS Mean difference|2.318||||0.0731|TWO_SIDED|95.0|-0.22|4.856|||Mixed-effects Model|||||4.856|-0.22|0.0731
71877756|NCT02871778|143274729|SUPERIORITY||LS Mean Difference|0.799||||0.5373|TWO_SIDED|95.0|-1.751|3.348|||Mixed-effects Model|||||3.348|-1.751|0.5373
71877757|NCT02871778|143274729|SUPERIORITY||LS Mean difference|0.838||||0.453|TWO_SIDED|95.0|-1.368|3.045|||Mixed-effects Model|||||3.045|-1.368|0.453
71877758|NCT02653300|143274738|OTHER|||||||0.03125|||||||Sign test|||||||0.03125
71877759|NCT02170779|143274741|SUPERIORITY_OR_OTHER|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||||||0.84
71877760|NCT02170779|143274742|SUPERIORITY_OR_OTHER|||||||0.738|||||||Wilcoxon (Mann-Whitney)|||||||0.738
71877761|NCT02170779|143274743|SUPERIORITY_OR_OTHER|||||||0.8434|||||||Wilcoxon (Mann-Whitney)|||||||0.8434
71877762|NCT02170779|143274744|SUPERIORITY_OR_OTHER|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||||||0.638
71877763|NCT02170779|143274745|SUPERIORITY_OR_OTHER|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||||||0.492
71877764|NCT02170779|143274746|SUPERIORITY_OR_OTHER|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||This analysis refers to the physical component of the MSIS-29||||0.144
71877765|NCT02170779|143274746|SUPERIORITY_OR_OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||This refers to the psychological analysis for the MSIS-29.||||0.953
71877766|NCT02170779|143274747|SUPERIORITY_OR_OTHER|||||||0.915|||||||Wilcoxon (Mann-Whitney)|||||||0.915
71877767|NCT02170779|143274748|SUPERIORITY_OR_OTHER|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||||||0.023
71877768|NCT02170779|143274749|SUPERIORITY_OR_OTHER|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71685158|NCT02191046|142888923|NON_INFERIORITY_OR_EQUIVALENCE|power fo study = 90%|Mean Difference (Final Values)|5.66|STANDARD_DEVIATION|3.16|<|0.05|TWO_SIDED|95.0|4.62|6.69|||t-test, 2 sided|||compare the mean 5s-score between before and after treatment in squeezable bottle group||6.69|4.62|<0.05
71877769|NCT01286454|143274750|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|111.23|||||TWO_SIDED|90.0|102.69|120.47||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||120.47|102.69|
71877770|NCT01286454|143274750|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.07|||||TWO_SIDED|90.0|95.16|111.64||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||111.64|95.16|
71877771|NCT01286454|143274750|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|70.36|||||TWO_SIDED|90.0|64.52|76.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||76.74|64.52|
71877772|NCT01286454|143274750|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|113.55|||||TWO_SIDED|90.0|105.91|121.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||121.74|105.91|
71877773|NCT01286454|143274751|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|112.8|||||TWO_SIDED|90.0|103.85|122.52||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||122.52|103.85|
71877774|NCT01286454|143274751|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.71|||||TWO_SIDED|90.0|95.48|112.65||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||112.65|95.48|
71758585|NCT01244893|143019452|NON_INFERIORITY_OR_EQUIVALENCE|This study uses -0.05 LogMAR as the non-inferiority margin.|Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.003|||TWO_SIDED|95.0|-0.00092|0.01045|||Mixed Models Analysis||The mean difference is calculated as the test lens - control lens.|"Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale"||0.01045|-0.00092|
71918553|NCT03031327|143358584|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED|95.0|-0.1|0.3|||Student t-test pooled|Pooled method for estimating common variance was used||Student t-test on changes from baseline in corneal sensitivity - Non Study eye - Day 15±2 pre-dose||0.3|-0.1|0.1
71918554|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.26|STANDARD_ERROR_OF_MEAN|0.26||0.309|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the motivational interviewing (MI) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.309
71918555|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.34|STANDARD_ERROR_OF_MEAN|0.26||0.19|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the personalized recommendation (PR) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.190
71918556|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.69|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the psychoeducation (PE) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.690
71918557|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.038|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis explores the effect of the repeated administration (RA) component on rates of treatment receipt over the entire study period. Results will help determine the proportional increase in odds of treatment seeking corresponding to receiving each chatbot component. Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||0.038
71922308|NCT00453349|143365036|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-1.9||||||95.0|-9.9|6.0|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||6.0|-9.9|
71685159|NCT00048997|142888929|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.07||||0.2853|TWO_SIDED|95.0|0.84|1.38||One-sided significance level of 0.025.|Log Rank||Prophylactic cranial irradiation (PCI) is the reference arm for the hazard ratio.|This study was designed to detect a 20% relative improvement in hazard rate: null hypothesis (observation): MST (median survival time) = 23.5 mo.; alternative hypothesis (PCI): MST= 29.4 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 1007 patients (527 deaths were required for the final analysis).||1.38|0.84|0.2853
71685160|NCT00048997|142888930|SUPERIORITY|||||||0.01|||||||Z-test, 2-sided|2-sided significance level = 0.05||||||0.01
71685161|NCT00048997|142888931|SUPERIORITY|||||||0.008|||||||Z-test, 2-sided|Significance level = 0.05||||||0.008
71685162|NCT00048997|142888932|SUPERIORITY|||||||0.2|||||||Z-test, 2-sided|Significance level = 0.05||||||0.20
71685163|NCT00048997|142888933|SUPERIORITY|||||||0.14|||||||Z-test, 2-sided|Significance level = 0.05||||||0.14
71685164|NCT00048997|142888934|SUPERIORITY|||||||0.52|||||||Z-test, 2-sided|Significance level = 0.05||||||0.52
71685165|NCT00048997|142888935|SUPERIORITY|||||||0.51|||||||Z-test, 2-sided|Significance level = 0.05||||||0.51
71877775|NCT01286454|143274751|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|66.87|||||TWO_SIDED|90.0|61.56|72.63||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||72.63|61.56|
71877776|NCT01286454|143274751|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|28.34|||||TWO_SIDED|90.0|26.09|30.78||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||30.78|26.09|
71685166|NCT00048997|142888936|SUPERIORITY|||||||0.11|||||||Other [Z-test, 2-sided]|Significance level = 0.05||||||0.11
71685167|NCT00048997|142888937|SUPERIORITY||Odds Ratio (OR)|2.52||||0.005|TWO_SIDED|95.0|1.32|4.8|||Regression, Logistic|2-sided significance level = 0.05|Reference level = PCI arm|The development of CNS metastases was assessed using logistic regression modeling comparing presence vs. absence of brain metastases at 1 year.||4.80|1.32|0.005
71685168|NCT02007278|142888947|NON_INFERIORITY_OR_EQUIVALENCE|Power=95%; significance level=5%, characteristic operation curves were used with a non-central F distribution for the calculation of the sample size||||||0.451|||||||Wilcoxon (Mann-Whitney)|||||||0.4510
71685169|NCT04475718|142888955|OTHER|Preliminary Efficacy|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71685170|NCT00435188|142888961|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Omnibus p value for group difference between groups at the end of the study and group by time interaction|Mixed Models Analysis|||||||<0.001
71685171|NCT00435188|142888964|SUPERIORITY_OR_OTHER|||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedom||||0.47
71685172|NCT00435188|142888967|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedom||||0.04
71685173|NCT00435188|142888968|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall differences between groups at the end of the study||||<0.001
71685174|NCT00435188|142888971|SUPERIORITY_OR_OTHER|||||||0.29|TWO_SIDED||||||Mixed Models Analysis|||Omnibus P value provides the overall difference between groups at the end of the study||||0.29
71685175|NCT00435188|142888974|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Mixed Models Analysis|||P value provides overall differences between groups at the end of the study||||0.35
71685176|NCT00435188|142888977|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Mixed Models Analysis|||P value provides the overall differences between groups at the end of the study||||0.08
71685177|NCT00055497|142888990|SUPERIORITY_OR_OTHER|||||||0.142|||||||Log Rank|||||||0.142
71685178|NCT00055497|142888991|SUPERIORITY_OR_OTHER|||||||0.029|||||||Fisher Exact|||||||0.029
71685179|NCT00055497|142888992|SUPERIORITY_OR_OTHER|||||||0.33|||||||Fisher Exact|||Week 24||||0.330
71685180|NCT00055497|142888992|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||Week 24||||0.001
71685181|NCT00055497|142888992|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
71685182|NCT00055497|142888992|SUPERIORITY_OR_OTHER|||||||0.044|||||||Fisher Exact|||Week 56||||0.044
71685183|NCT00055497|142888993|SUPERIORITY_OR_OTHER|||||||0.191|||||||Fisher Exact|||Week 24||||0.191
71685184|NCT00055497|142888993|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||Week 24||||0.003
71685185|NCT00055497|142888993|SUPERIORITY_OR_OTHER|||||||0.508|||||||Fisher Exact|||Week 56||||0.508
71685186|NCT00055497|142888993|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||Week 56||||0.004
71685187|NCT00055497|142888994|SUPERIORITY_OR_OTHER|||||||0.001|||||||Fisher Exact|||||||0.001
71685188|NCT00048165|142888999|SUPERIORITY_OR_OTHER||percent mean difference|-12.0||||0.007|TWO_SIDED|95.0|-20.9|-3.3|||Cochran-Mantel-Haenszel|||||-3.3|-20.9|0.007
71685189|NCT00048165|142889000|SUPERIORITY_OR_OTHER||percent mean difference|-8.6||||0.063|TWO_SIDED|95.0|-17.7|0.5|||Cochran-Mantel-Haenszel|||||0.5|-17.7|0.063
71685190|NCT00048165|142889003|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 6 months were presented||||0.0005
71685191|NCT00048165|142889003|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 12 months were presented||||0.0008
71685192|NCT01693185|142889036|SUPERIORITY_OR_OTHER||||||<|0.001||||||We wished to be able to distinguish a difference of 7.5 min,|Wilcoxon (Mann-Whitney)|||Recovery time in patients administered remifentanil alone will be significantly shorter than that in patients administered midazolam-meperidine combination for colonoscopy.||||< 0.001
71685193|NCT02503254|142889064|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|82.82|||<|0.001|TWO_SIDED|95.0|78.79|86.09||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||86.09|78.79|<.001
71877777|NCT01286454|143274751|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|114.7|||||TWO_SIDED|90.0|106.99|122.97||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||122.97|106.99|
71918558|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.16||0.735|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.735
71918559|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.91|STANDARD_ERROR_OF_MEAN|0.27||0.001|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.001
71918560|NCT04806165|143358605|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data. The model was estimated using a logit link and did not incorporate an intercept.|Regression (Beta) Coefficient|-0.73|STANDARD_ERROR_OF_MEAN|0.3||0.014|TWO_SIDED|||||We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0. We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Discrete Time Survival Analysis|The model did not incorporate an intercept to allow for estimation of treatment receipt likelihood among participants yet to report treatment.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on treatment receipt, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on). Discrete time survival analysis was employed and models were fit with treatment seeking regressed on follow-up time (2-week, 6-week, or 14-week) and each chatbot component.||||.014
71922309|NCT00453349|143365037|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-3.2||||||95.0|-7.4|0.8|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||0.8|-7.4|
71685194|NCT02503254|142889065|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|63.53|||<|0.001|TWO_SIDED|95.0|59.55|67.12||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively"||67.12|59.55|<0.001
71685195|NCT02503254|142889066|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Reduction|88.14|||<|0.001|TWO_SIDED|95.0|86.46|89.62||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."||89.62|86.46|<.001
71685196|NCT02503254|142889067|SUPERIORITY_OR_OTHER_LEGACY||Geometric LS Mean Ratio|58.83|||<|0.001|TWO_SIDED|95.0|49.3|66.56||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~* Null hypothesis (H0): m1≥m2~* Alternative hypothesis (H1): m1\<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC respectively."||66.56|49.30|<.001
71685197|NCT00350779|142889096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72|STANDARD_DEVIATION|0.87|<|0.001||95.0|-0.95|-0.49|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.49|-0.95|<0.001
71685198|NCT00350779|142889097|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.0|STANDARD_DEVIATION|31.3|<|0.001||95.0|-27.2|-10.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-10.9|-27.2|<0.001
71685199|NCT00350779|142889098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-37.9|STANDARD_DEVIATION|43.7|<|0.001||95.0|-50.2|-25.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-25.5|-50.2|<0.001
71877778|NCT01286454|143274752|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|259.4|||||TWO_SIDED|90.0|231.48|290.7||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.||290.70|231.48|
71877779|NCT01286454|143274752|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|134.83|||||TWO_SIDED|90.0|120.31|151.09||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.||151.09|120.31|
71918561|NCT04806165|143358606|SUPERIORITY|Gender, age, and race were included as auxiliary variables to improve imputation quality. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. For sensitivity analysis, models were run again using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.53||||0.25|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|||Analyses were conducted to determine the effects of each of the four chatbot components on secondary outcomes. This analysis in particular explores the effects of the motivational interviewing component (MI) on participant willingness to seek psychotherapy for concerns their disordered weight and shape behaviors and thoughts since engagement with the intervention. Linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||||0.25
71685200|NCT00350779|142889099|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.77|STANDARD_DEVIATION|1.04|<|0.001||95.0|-1.04|-0.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-0.50|-1.04|<0.001
71685201|NCT00350779|142889100|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.4|STANDARD_DEVIATION|34.6|<|0.001||95.0|-26.4|-8.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-8.4|-26.4|<0.001
71685202|NCT00350779|142889101|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-34.1|STANDARD_DEVIATION|51.0|<|0.001||95.0|-48.4|-19.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy||||-19.9|-48.4|<0.001
71685203|NCT02227368|142889123|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.3441|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.1|-0.4|0.3441
71685204|NCT02227368|142889124|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.6186|TWO_SIDED|95.0|-0.4|0.6|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.|||0.6|-0.4|0.6186
71758586|NCT02282605|143019485|SUPERIORITY_OR_OTHER|||||||0.792|||||||Fisher Exact|||||||0.792
71758587|NCT02282605|143019485|SUPERIORITY_OR_OTHER|||||||0.887|||||||Fisher Exact|||||||0.887
71685205|NCT04494425|142889125|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.52|0.75|||Log Rank|The analysis was performed using the stratified log-rank test.|HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for prior cyclin-dependent kinase (CDK)4/6 inhibitor use (yes versus no) and HER2 IHC expression (IHC 1+ versus IHC 2+/ISH-) and ties handled by Efron approach.|||0.75|0.52|<0.0001
71877780|NCT01286454|143274752|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|48.58|||||TWO_SIDED|90.0|43.35|54.44||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.||54.44|43.35|
71877781|NCT01286454|143274752|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|14.38|||||TWO_SIDED|90.0|12.83|16.11||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.||16.11|12.83|
71877782|NCT01286454|143274752|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|171.06|||||TWO_SIDED|90.0|115.82|187.78||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.||187.78|115.82|
71877783|NCT00369785|143274755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.62||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in immediate recall memory at 24 weeks||||.62
71877784|NCT00369785|143274756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in discrimination memory between the two groups||||.007
71877785|NCT00800683|143274757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-0.89|-0.31|||ANCOVA|||For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.||-0.31|-0.89|< 0.0001
71877786|NCT00800683|143274758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.03|-0.41|||ANCOVA|||||-0.41|-1.03|< 0.0001
71877787|NCT00800683|143274759|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.9|-0.33|||ANCOVA|||||-0.33|-0.90|< 0.0001
71877788|NCT00800683|143274760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001||95.0|-0.96|-0.41|||ANCOVA|||||-0.41|-0.96|< 0.0001
71685206|NCT01760447|142889144|SUPERIORITY||Least Squares Mean Difference|-0.49|||=|0.018|TWO_SIDED|95.0|-0.9|-0.09|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-0.09|-0.90|= 0.018
71877789|NCT00800683|143274761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.05|-0.39|||ANCOVA|||||-0.39|-1.05|< 0.0001
71877790|NCT00800683|143274762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-1.06|-0.44|||ANCOVA|||||-0.44|-1.06|< 0.0001
71877791|NCT00800683|143274763|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001||95.0|-0.96|-0.33|||ANCOVA|||||-0.33|-0.96|< 0.0001
71877792|NCT00800683|143274764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001||95.0|-1.02|-0.44|||ANCOVA|||||-0.44|-1.02|< 0.0001
71877793|NCT00800683|143274765|SUPERIORITY_OR_OTHER|||||||0.1199||95.0||||P-value calculated using a Fisher's exact Test.|Fisher Exact|||||||0.1199
71877794|NCT00800683|143274766|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.103||||0.2225||95.0|0.003|3.978|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||3.978|0.003|0.2225
71877795|NCT00800683|143274767|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.816||||0.8927|TWO_SIDED|95.0|0.042|15.756|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance||15.756|0.042|0.8927
71877796|NCT00800683|143274768|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.73|STANDARD_ERROR_OF_MEAN|11.43||0.8802||95.0|-24.36|20.91|||ANCOVA|||||20.91|-24.36|0.8802
71877797|NCT00800683|143274769|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.24|STANDARD_ERROR_OF_MEAN|8.19||0.7848||95.0|-18.47|13.98|||ANCOVA|||||13.98|-18.47|0.7848
71758588|NCT02282605|143019486|SUPERIORITY_OR_OTHER|||||||0.0058||||||For timepoint Day 3 (12 hours after last dose)|Fisher Exact|||||||0.0058
71877798|NCT00800683|143274770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.72|STANDARD_ERROR_OF_MEAN|8.09||0.1878||95.0|-26.74|5.31|||ANCOVA|||||5.31|-26.74|0.1878
71877799|NCT00800683|143274771|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.42|STANDARD_ERROR_OF_MEAN|7.92||0.5781||95.0|-11.28|20.12|||ANCOVA|||||20.12|-11.28|0.5781
71877800|NCT00800683|143274772|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.24|STANDARD_ERROR_OF_MEAN|8.8||0.2954||95.0|-26.67|8.18|||ANCOVA|||||8.18|-26.67|0.2954
71877801|NCT00800683|143274773|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.37|STANDARD_ERROR_OF_MEAN|8.27||0.5984||95.0|-12.02|20.75|||ANCOVA|||||20.75|-12.02|0.5984
71877802|NCT00800683|143274774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.07|STANDARD_ERROR_OF_MEAN|8.53||0.4085||95.0|-9.82|23.96|||ANCOVA|||||23.96|-9.82|0.4085
71685207|NCT01760447|142889145|OTHER||Difference in Percentage|-1.3|||||TWO_SIDED|95.0|-13.9|11.3|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||11.3|-13.9|
71918562|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.36||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the psychoeducation component (PE) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
71918563|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.25||||0.44|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the personalized recommendation component (PR) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.44
71918564|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.29||||0.53|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the effects of each of the four chatbot components on willingness to seek psychotherapy. This analysis in particular explores the effects of the repeated administration component (RA) on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||0.53
71918565|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.53||||0.07|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 2 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.07
71918566|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-1.06||||0.01|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 6 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.01
71685208|NCT01760447|142889146|OTHER||Difference in Percentage|-0.5|||||TWO_SIDED|95.0|-6.2|5.0|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.0|-6.2|
71685209|NCT01760447|142889147|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-8.9|14.4|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who experienced ≥1 adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||14.4|-8.9|
71685210|NCT01760447|142889148|OTHER||Difference in Percentage|-2.1|||||TWO_SIDED|95.0|-10.1|5.8|||||The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.|"The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||5.8|-10.1|
71685211|NCT01760447|142889150|SUPERIORITY||Least Squares Mean Difference|-10.8|||=|0.159|TWO_SIDED|95.0|-25.9|4.3|||Mixed Models Analysis|||"The Least Squares (LS) Mean for the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||4.3|-25.9|= 0.159
71685212|NCT01760447|142889152|SUPERIORITY||Difference in Percentage|16.0||||0.017|TWO_SIDED|95.0|2.9|28.9|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<7.0%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||28.9|2.9|0.017
71685213|NCT01760447|142889153|SUPERIORITY||Difference in Percentage|12.2||||0.049|TWO_SIDED|95.0|0.0|24.8|||Miettinen and Nurminen|||"The percentage of participants with A1C at the A1C goal (\<6.5%) in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled. For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal."||24.8|0.0|0.049
71685214|NCT01760447|142889156|SUPERIORITY||Kaplan-Meier Difference in Percentage|-13.2||||0.002|TWO_SIDED|95.0|-21.1|-5.3|||Log-Rank Test|||"The percentage of participants initiating glycemic rescue therapy in the arm Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled is compared against that of Metformin and Metformin XR Pooled."||-5.3|-21.1|0.002
71685215|NCT04575584|142889163|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.562|TWO_SIDED|95.0|0.68|1.45|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.45|0.68|0.5620
71685216|NCT04575584|142889163|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.3145|TWO_SIDED|95.0|0.78|1.65|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.65|0.78|0.3145
71685217|NCT04575584|142889163|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.4894|TWO_SIDED|95.0|0.69|1.47|||Log Rank||Based on Cox regression model with Efron's method of tie handling|||1.47|0.69|0.4894
71685218|NCT04575584|142889166|SUPERIORITY||Mean Difference (Final Values)|4.1||||0.1642|TWO_SIDED|95.0|-2.3|12.1|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.1|-2.3|0.1642
71685219|NCT04575584|142889166|SUPERIORITY||Mean Difference (Final Values)|5.5||||0.09|TWO_SIDED|95.0|-1.1|13.9|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||13.9|-1.1|0.0900
71685220|NCT04575584|142889166|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.1594|TWO_SIDED|95.0|-2.3|12.3|||Miettinen and Nurminen method||Miettinen and Nurminen method. Unknown Day 29 survival status treated as failure.|||12.3|-2.3|0.1594
71685221|NCT04575584|142889167|SUPERIORITY||Odds Ratio (OR)|1.31||||0.3623|TWO_SIDED|95.0|0.73|2.35|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. Confidence intervals (CIs) are based on Wald Chi-Square Test.|||2.35|0.73|0.3623
71685222|NCT04575584|142889167|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
71685223|NCT04575584|142889167|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
71877803|NCT00800683|143274775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|8.17||0.8698||95.0|-14.84|17.52|||ANCOVA|||||17.52|-14.84|0.8698
71877804|NCT02367066|143274778|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|STANDARD_ERROR_OF_MEAN|0.02||0.02|TWO_SIDED|80.0|0.9|0.98||1-sided|Mixed Models Analysis|||||0.98|0.90|0.02
71877805|NCT02367066|143274779|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|STANDARD_ERROR_OF_MEAN|0.03||0.06|TWO_SIDED|80.0|0.92|0.99||1-sided|Mixed Models Analysis|||||0.99|0.92|0.06
71877806|NCT02367066|143274780|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|STANDARD_ERROR_OF_MEAN|0.03||0.41|TWO_SIDED|80.0|0.96|1.03||1-sided|Mixed Models Analysis|||||1.03|0.96|0.41
71877807|NCT02367066|143274781|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.92|STANDARD_ERROR_OF_MEAN|0.05||0.06|TWO_SIDED|80.0|0.85|0.99||1-sided|Mixed Models Analysis|||||0.99|0.85|0.06
71877808|NCT02367066|143274782|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.06|STANDARD_ERROR_OF_MEAN|0.04||0.18|TWO_SIDED|80.0|0.99|1.13||1-sided|Mixed Models Analysis|||||1.13|0.99|0.18
71877809|NCT02367066|143274783|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.93|STANDARD_ERROR_OF_MEAN|0.04||0.04|TWO_SIDED|80.0|0.89|0.98||1-sided|Mixed Models Analysis|||||0.98|0.89|0.04
71877810|NCT02367066|143274785|SUPERIORITY_OR_OTHER||Geometric LS MEan Ratio|1.0|STANDARD_ERROR_OF_MEAN|0.05||0.37|TWO_SIDED|80.0|0.91|1.06||1-sided|Mixed Models Analysis|||||1.06|0.91|0.37
71877811|NCT02367066|143274787|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.02|STANDARD_ERROR_OF_MEAN|0.01||0.06|TWO_SIDED|80.0|1.0|1.04||1-sided|Mixed Models Analysis|||||1.04|1.00|0.06
71877812|NCT02367066|143274788|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.01||0.45|TWO_SIDED|90.0|-0.01|0.03||2-sided|Mixed Models Analysis|||||0.03|-0.01|0.45
71877813|NCT01898689|143274805|EQUIVALENCE|The a priori equivalence region for the difference in means between the two concentrations was specified as +10 mA. This value was considered the minimal clinically relevant current since it approximates the tolerated electrical current range at baseline of the general population-in other words, natural variability and therefore a relatively small amount of current to detect.|Mean Difference (Net)|0.2||||0.02|TWO_SIDED|90.0|-8.2|8.5||"P-values from the TOST procedure were 0.02 and 0.03 for the mean being inside the lower and upper boundaries, respectively.~(estimated mean difference of 0.2 mA; 90% CI 28.2 to 8.5)"|Mixed Models Analysis|||"The null and alternative hypotheses were thus:~H0: m0.1%-m0.4% ≤ -10 or m0.1%-m0.4% ≥ 10 and Ha: -10 , m0.1%-m0.4% , 10 where m0.1% and m0.1% are the population means for tolerance to current under 0.1% and 0.4% ropivacaine, respectively.~With 24 evaluable subjects, we had 90% power at the 0.05 significance level to detect equivalence of 0.1% and 0.4% ropivacaine concentration on the mean tolerance to transcutaneous electrical stimulation"||8.5|-8.2|0.02
71877814|NCT04556136|143274810|NON_INFERIORITY|This non-inferiority study was designed to demonstrate the ability of the phototherapy kiosk to safely administer UVB radiation to participants with varying levels of 25(OH)D and achieve comparable levels of serum 25(OH)D in a similar population of adults randomized to receive RDA of 600 IU vitamin D oral supplementation daily. It is important to evaluate device equivalence to standard of care in the maintenance of sufficient levels of vitamin D in adults 18 - 70 years old.||||||0.01||||||Threshold for significance \<0.05|Wilcoxon (Mann-Whitney)|Effect sizes for significant differences were included as eta squared (ŋ2) values.||The intent-to-treat analysis plan was carried out with all available subject data points. No interim analysis was performed. Exploratory data analyses were conducted on serum vitamin D levels of participants assigned to either the oral supplementation or kiosk group. Analysis was restricted to participants with valid baseline serum vitamin D data and at least one follow-up blood draw. The Shapiro-Wilk test was used to assess the normality of the data distribution.||||0.01
71877815|NCT03492554|143274821|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Specificity = 92% H1: Specificity \> 92 Under the assumption that the true population specificity is 96.5%, 226 subjects who were diagnosed with SR based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject its null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms approximately 300 subjects with no known diagnosis of AF were enrolled.||||<0.0001
71877816|NCT03492554|143274822|OTHER||||||<|0.0001|||||||1 sided exact binomial test|||H0: Sensitivity = 90% H1: Sensitivity \> 90% Under the assumption that the true population sensitivity is 95%, 231 subjects who were diagnosed with AF based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject the null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms, a minimum of 260 subjects with a known diagnosis of AF were enrolled.||||<0.0001
71877817|NCT03492554|143274823|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of visual display= 0.8 H1: agreement proportion of visual display\> 0.8 Under the assumption that the true population agreement proportion of visual display was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
71922310|NCT00453349|143365038|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
71758589|NCT02282605|143019488|SUPERIORITY_OR_OTHER|||||||0.028||||||The adjusted means were compared for the two-day treatment period.|ANCOVA|||||||0.028
71918567|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.85||||0.042|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis provides results on the 14 week time point post Intervention and contributes to understanding of the effect of time since chatbot engagement on willingness to seek psychotherapy, regardless of the combination of the four chatbot components participants were assigned (ie., component turned off or on).||||0.042
71918568|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.08||||0.89|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.89
71918569|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.34||||0.69|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.69
71918570|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.69||||0.4|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the motivational interviewing (MI) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.40
71922311|NCT00453349|143365039|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|5.4||||||95.0|-12.7|20.3|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||20.3|-12.7|
71685224|NCT04575584|142889168|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4398|TWO_SIDED|95.0|0.7|2.3|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.30|0.70|0.4398
71758590|NCT02282605|143019488|SUPERIORITY_OR_OTHER||||||<|0.001||||||The adjusted means were compared for the two-day treatment period to discharge.|ANCOVA|||||||<0.001
71918571|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.35||||0.55|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.55
71918572|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.88||||0.32|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.32
71918573|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.37||||0.63|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the psychoeducation (PE) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.63
71918574|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.08||||0.9|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.90
71918575|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.95||||0.27|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.27
71922312|NCT00453349|143365040|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|4.3||||||95.0|-19.4|17.6|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||17.6|-19.4|
71758591|NCT02282605|143019488|SUPERIORITY_OR_OTHER|||||||0.005||||||The adjusted means were compared for the two-day treatment period through to discharge|ANCOVA|||||||0.005
71918576|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.67||||0.42|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the personalized recommendation (PR) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.42
71685225|NCT04575584|142889168|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
71918577|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.23||||0.04|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 2-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.04
71877818|NCT03492554|143274824|OTHER||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of R wave amplitude = 0.8 H1: agreement proportion of R wave amplitude \> 0.8 Under the assumption that the true population agreement proportion of R wave amplitude was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.||||<0.0001
71877819|NCT01196533|143274831|SUPERIORITY_OR_OTHER||||||||||||||||||All data in the outcome measure table is presenting the percentage of error.|||
71877820|NCT01289821|143274834|SUPERIORITY_OR_OTHER||Percentage of Participants|43.9||||0.36|TWO_SIDED|80.0|33.19|55.09|||One-sample exact binomial test|||"Null hypothesis: True probability p of objective tumor response does not exceed p0, p0=0.4. H0: p\<=0.4 One-sided type I error probability of alpha=10%"||55.09|33.19|0.36
71877821|NCT03591354|143274840|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71877822|NCT02901574|143274913|SUPERIORITY||Mean Difference (Final Values)|3.87||||0.24|TWO_SIDED|95.0|-2.55|10.3||Threshold for significance is two-sided alpha of 0.05.|Mixed Models Analysis|||||10.30|-2.55|0.24
71877823|NCT01010633|143274928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.3|||<|0.001|TWO_SIDED|95.0|5.7|22.9|||Chi-squared|||||22.9|5.7|<0.001
71877824|NCT01010633|143274930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.0|||<|0.001|TWO_SIDED|95.0|21.4|40.7|||Chi-squared|||||40.7|21.4|<0.001
71877825|NCT04666350|143274932|OTHER||Combined Difference in Prevalence|-0.025||||0.711|TWO_SIDED|95.0|-0.16|0.109|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.109|-0.160|0.711
71877826|NCT04666350|143274932|OTHER||Combined Difference in Prevalence|-0.016||||0.795|TWO_SIDED|95.0|-0.139|0.107|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in oocyte prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.107|-0.139|0.795
71877827|NCT04666350|143274933|OTHER||Relative Rate|0.38||||0.019|TWO_SIDED|95.0|0.21|0.7||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DSFA Day 2 versus Day 1.||0.70|0.21|0.019
71758592|NCT03584789|143019497|SUPERIORITY||Odds Ratio (OR)|1.29||||0.08|TWO_SIDED|97.5|0.93|1.8|||Mixed Models Analysis|||||1.80|.93|.08
71877828|NCT04666350|143274933|OTHER||Relative Rate|0.23||||0.003|TWO_SIDED|95.0|0.11|0.45||Difference between days was evaluated using zero inflated Poisson regression models having as outcome the number of oocysts, as offset the number of surviving mosquitoes, and adjusted by subject.|Poisson Regression|||Comparison of DMFA Day 2 versus Day 1.||0.45|0.11|0.003
71877829|NCT04666350|143274934|OTHER||Combined Difference in Prevalence|-0.023||||0.75|TWO_SIDED|95.0|-0.164|0.118|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DSFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DSFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.118|-0.164|0.750
71685226|NCT04575584|142889168|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
71685227|NCT04575584|142889169|SUPERIORITY||Odds Ratio (OR)|1.48||||0.2422|TWO_SIDED|95.0|0.77|2.85|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.85|0.77|0.2422
71685228|NCT04575584|142889169|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
71877830|NCT04666350|143274934|OTHER||Combined Difference in Prevalence|-0.031||||0.681|TWO_SIDED|95.0|-0.178|0.117|||Other|The p-value is estimated assuming the combined difference over the square root of the weighted variance follows a normal distribution.||Comparison of DMFA Day 2 versus Day 1. For each participant, the difference in sporozoite prevalence using DMFA on Day 1 versus Day 2 was estimated. To evaluate the hypothesis that the average mean difference in the prevalence between two assays within the same subject is zero, combined estimates (weighted mean and variance) were obtained using as weight the inverse of the variance of each paired difference obtained from the Agresti and Caffo method.||0.117|-0.178|0.681
71877831|NCT02463071|143274936|SUPERIORITY||Mean Difference (Final Values)|-26.72|STANDARD_ERROR_OF_MEAN|4.96|<|0.0001|TWO_SIDED|95.0|-36.55|-16.88|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-16.88|-36.55|<0.0001
71877832|NCT02463071|143274936|SUPERIORITY||Mean Difference (Final Values)|-32.92|STANDARD_ERROR_OF_MEAN|5.04|<|0.0001|TWO_SIDED|95.0|-42.93|-22.92|||ANCOVA|Baseline TG and statin usage were included as covariates.||||-22.92|-42.93|<0.0001
71877833|NCT00097773|143274954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.86|TWO_SIDED|95.0|0.54|1.66||There was no significant interaction with ciprofloxacin in this analysis.|Regression, Cox||risk of exacerbation comparing cycled therapy to culture-based therapy|The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.||1.66|0.54|0.86
71877834|NCT00097773|143274954|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.2|TWO_SIDED|95.0|0.82|2.54|||Regression, Cox||risk of exacerbation comparing oral cipro to oral placebo|A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||2.54|0.82|0.20
71877835|NCT00097773|143274955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.28||95.0|0.49|1.23|||Regression, Logistic|No interaction with ciprofloxacin usage was observed.|odds of a positive culture comparing cycled therapy to culture-based therapy|Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.||1.23|0.49|0.28
71877836|NCT00097773|143274955|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.67|TWO_SIDED|95.0|0.71|1.71|||Regression, Logistic||odds of a positive culture comparing the cipro group to the placebo group|Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.||1.71|0.71|0.67
71685229|NCT04575584|142889169|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6052|TWO_SIDED|95.0|0.45|1.59|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.59|0.45|0.6052
71685230|NCT04575584|142889170|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
71685231|NCT04575584|142889170|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
71685232|NCT04575584|142889170|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
71877837|NCT00097773|143274956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.18|TWO_SIDED|95.0|0.58|1.11|||Regression, Cox|No interaction with ciprofloxacin usage was observed.|Hazard ratio comparing cycled to culture based therapy|The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.||1.11|0.58|0.18
71877838|NCT00097773|143274956|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.12|TWO_SIDED|95.0|0.94|1.78|||Regression, Cox||Hazard ratio comparing cipro to placebo.|This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.||1.78|0.94|0.12
71685233|NCT04575584|142889171|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9945|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9945
71685234|NCT04575584|142889171|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
71877839|NCT00713817|143275021|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|0.89||||0.273|TWO_SIDED|95.0|-0.78|2.56|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||2.56|-0.78|0.273
71685235|NCT04575584|142889171|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
71685236|NCT04575584|142889172|SUPERIORITY||Odds Ratio (OR)|1.25||||0.4472|TWO_SIDED|95.0|0.7|2.25|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.25|0.70|0.4472
71685237|NCT04575584|142889172|SUPERIORITY||Odds Ratio (OR)|1.18||||0.5714|TWO_SIDED|95.0|0.66|2.12|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.12|0.66|0.5714
71685238|NCT04575584|142889172|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9313|TWO_SIDED|95.0|0.54|1.75|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.54|0.9313
71685239|NCT04575584|142889173|SUPERIORITY||Odds Ratio (OR)|1.22||||0.5222|TWO_SIDED|95.0|0.67|2.21|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.21|0.67|0.5222
71685240|NCT04575584|142889173|SUPERIORITY||Odds Ratio (OR)|0.86||||0.6277|TWO_SIDED|95.0|0.47|1.57|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.57|0.47|0.6277
71685241|NCT04575584|142889173|SUPERIORITY||Odds Ratio (OR)|0.89||||0.7069|TWO_SIDED|95.0|0.49|1.62|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.62|0.49|0.7069
71758593|NCT03584789|143019497|SUPERIORITY||Odds Ratio (OR)|1.24||||0.18|TWO_SIDED|97.5|0.86|1.79|||Mixed Models Analysis|||||1.79|.86|.18
71685242|NCT04575584|142889174|SUPERIORITY||Odds Ratio (OR)|1.46||||0.2627|TWO_SIDED|95.0|0.75|2.8|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.80|0.75|0.2627
71685243|NCT04575584|142889174|SUPERIORITY||Odds Ratio (OR)|1.27||||0.4789|TWO_SIDED|95.0|0.66|2.44|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.44|0.66|0.4789
71685244|NCT04575584|142889174|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5938|TWO_SIDED|95.0|0.45|1.58|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.58|0.45|0.5938
71877840|NCT00713817|143275022|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|4.62||||0.296|TWO_SIDED|95.0|-4.51|13.75|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||13.75|-4.51|0.296
71877841|NCT00713817|143275023|SUPERIORITY_OR_OTHER_LEGACY||Chi-square|0.048||||0.826||95.0|||||Log Rank|||Time to treatment failure was analysed using Kaplan-Meier Survival analysis methodology. The difference in loss of response cumulative distribution function between treatments was assessed using the Hodges-Lehmann estimate.||||0.826
71877842|NCT00713817|143275024|SUPERIORITY_OR_OTHER_LEGACY||Estimated mean treatment difference|-7.14||||0.54|TWO_SIDED|95.0|-39.7|9.62|||Hodges-Lehmann|||The difference in loss of response cumulative distribution functions between treatments was assessed using the Wilcoxon test with an estimate of the median difference between groups in response level (percent change from baseline) provided by the Hodges-Lehmann estimator.||9.62|-39.7|0.54
71877843|NCT00713817|143275025|SUPERIORITY_OR_OTHER_LEGACY||Estimate mean treatment difference|-0.08||||0.902|TWO_SIDED|95.0|-1.45|1.29|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.||1.29|-1.45|0.902
71877844|NCT00713817|143275026|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.557||||0.603|TWO_SIDED|95.0|0.293|8.261|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated the parent Randomised Controlled Trials (RCTs). The interaction between treatment group and parent RCTs was investigated, but was dropped from the model if found to have little influence. The test was performed at the 10% significance level. The final model was then treatment group and parent RCTs, i.e. the treatment effect was adjusted for parent RCTs baseline.||8.261|0.293|0.603
71877845|NCT04415658|143275036|SUPERIORITY||Risk Ratio (RR)|1.01||||0.57|TWO_SIDED|95.0|0.97|1.07|||Chi-squared, Corrected|||80% power to detect a 10% increase in hearts transplanted||1.07|0.97|0.57
71877846|NCT04415658|143275037|NON_INFERIORITY|Six percent margin, assuming 96% graft survival in control group|Mean Difference (Final Values)|1.9|||<|0.001|TWO_SIDED|95.0|-2.3|6.0|||Regression, Logistic|||Non-inferiority analysis for thyroxine vs saline||6.0|-2.3|<0.001
71922332|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccines Group Differences at Day 86|11.0|||||TWO_SIDED|97.5|1.7|21.3|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA||21.3|1.7|
71685245|NCT04575584|142889175|SUPERIORITY||Odds Ratio (OR)|1.47||||0.2644|TWO_SIDED|95.0|0.75|2.88|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.75|0.2644
71685246|NCT04575584|142889175|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2184|TWO_SIDED|95.0|0.77|3.14|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.14|0.77|0.2184
71877847|NCT01480284|143275109|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was judged based on the one-sided test of the model, y(Δ) = Baseline + Group ( Δ= -1.0). The adjusted mean values of the TDF group and the ETV group were calculated, and the adjusted mean value and two-sided 95% confidence interval of differences between the TDF group and the ETV group were calculated. Non-inferiority was also to be confirmed when the upper limit of the calculated two-sided 95% confidence interval was less than the non-inferiority limit value of 1.0|Mean Difference (Final Values)|-0.13|||<|0.0001|TWO_SIDED|95.0|-0.28|0.02||p-value was compared with the significance level of 0.025|ANCOVA|||||0.02|-0.28|<0.0001
71877848|NCT01480284|143275110|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.4|0.39|||||CI and estimate difference is provided for change from Baseline in serum HBV DNA level at Week 48.|||0.39|-0.40|
71922333|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccines Group differences at Day 86|19.0|||||TWO_SIDED|97.5|9.9|29.2|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC||29.2|9.9|
71685247|NCT04575584|142889175|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9771|TWO_SIDED|95.0|0.53|1.94|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.94|0.53|0.9771
71758594|NCT03584789|143019498|SUPERIORITY||Odds Ratio (OR)|1.37||||0.71|TWO_SIDED|97.5|0.2|9.44|||Mixed Models Analysis|||||9.44|.20|.71
71685248|NCT04575584|142889176|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9445|TWO_SIDED|95.0|0.46|2.06|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.06|0.46|0.9445
71685249|NCT04575584|142889176|SUPERIORITY||Odds Ratio (OR)|1.5||||0.3227|TWO_SIDED|95.0|0.67|3.37|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.37|0.67|0.3227
71685250|NCT04575584|142889176|SUPERIORITY||Odds Ratio (OR)|0.79||||0.52|TWO_SIDED|95.0|0.39|1.61|||Wald Chi-Square||Based on the proportional odds model with Pulmonary+ score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.39|0.5200
71685251|NCT04575584|142889177|SUPERIORITY||Odds Ratio (OR)|1.07||||0.8732|TWO_SIDED|95.0|0.46|2.47|||Wald Chi-Square||Proportional odds model with National Early Warning Score (NEWS) categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.47|0.46|0.8732
71685252|NCT04575584|142889177|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1277|TWO_SIDED|95.0|0.25|1.19|||Wald Chi-square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.19|0.25|0.1277
71685253|NCT04575584|142889177|SUPERIORITY||Odds Ratio (OR)|0.73||||0.4326|TWO_SIDED|95.0|0.33|1.61|||Wald Chi-Square||Proportional odds model with NEWS categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.61|0.33|0.4326
71685254|NCT04575584|142889178|SUPERIORITY||Odds Ratio (OR)|1.2||||0.683|TWO_SIDED|95.0|0.5|2.88|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.88|0.50|0.6830
71685255|NCT04575584|142889178|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.42|2.39|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.39|0.42|1.000
71685256|NCT04575584|142889178|SUPERIORITY||Odds Ratio (OR)|0.9||||0.8244|TWO_SIDED|95.0|0.37|2.2|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.20|0.37|0.8244
71685257|NCT04575584|142889179|SUPERIORITY||Odds Ratio (OR)|0.77||||0.5022|TWO_SIDED|95.0|0.36|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.36|0.5022
71685258|NCT04575584|142889179|SUPERIORITY||Odds Ratio (OR)|0.78||||0.5204|TWO_SIDED|95.0|0.37|1.64|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.64|0.37|0.5204
71685259|NCT04575584|142889179|SUPERIORITY||Odds Ratio (OR)|0.52||||0.0991|TWO_SIDED|95.0|0.24|1.13|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.13|0.24|0.0991
71685260|NCT04575584|142889180|SUPERIORITY||Odds Ratio (OR)|1.18||||0.6346|TWO_SIDED|95.0|0.6|2.29|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.29|0.60|0.6346
71685261|NCT04575584|142889180|SUPERIORITY||Odds Ratio (OR)|0.9||||0.7596|TWO_SIDED|95.0|0.46|1.75|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.75|0.46|0.7596
71685262|NCT04575584|142889180|SUPERIORITY||Odds Ratio (OR)|0.95||||0.8879|TWO_SIDED|95.0|0.49|1.84|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.84|0.49|0.8879
71685263|NCT04575584|142889181|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6002|TWO_SIDED|95.0|0.55|2.82|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.82|0.55|0.6002
71877849|NCT00709111|143275126|SUPERIORITY_OR_OTHER|||||||0.97||||||The p-value is one-sided with a nominal level of 0.05.|Wilcoxon signed-rank, 1-sided|||The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change \<20 cells/mm\^3. The study was powered to yield 80% power to show that there was \>=20 cells/mm\^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm\^3, a standard deviation of 60 cells/mm\^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.||||0.97
71877850|NCT02716675|143275172|OTHER||Prevention Efficacy (PE)|26.6||||0.15|TWO_SIDED|95.0|-11.7|51.8||The threshold for statistical significance was p = 0.05.|wald|||The primary PE analysis tests the null hypothesis PE equal to zero versus the alternative hypothesis PE not equal to zero using a 2-sided alpha equal 0.05 level Wald test of the equality of log cumulative hazard functions at the week 80 visit for the pooled VRC01 group versus the placebo group.||51.8|-11.7|0.15
71877851|NCT02716675|143275172|OTHER||Prevention Efficacy (PE)|22.4|||||TWO_SIDED|95.0|-25.5|52.0||||||A secondary analysis assesses the overall PE of the low-dose VRC01 group versus the placebo group.||52.0|-25.5|
71877852|NCT02716675|143275172|OTHER||Prevention Efficacy (PE)|30.9|||||TWO_SIDED|95.0|-13.9|58.0||||||A secondary analysis assesses the overall PE of the high-dose VRC01 group versus the placebo group.||58.0|-13.9|
71877853|NCT02716675|143275174|OTHER||Prevention Efficacy (PE)|73.0|||||TWO_SIDED|95.0|27.6|89.9||||||PE against IC80 of least sensitive variant less than 1||89.9|27.6|
71685264|NCT04575584|142889181|SUPERIORITY||Odds Ratio (OR)|1.37||||0.4733|TWO_SIDED|95.0|0.58|3.21|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.21|0.58|0.4733
71685265|NCT04575584|142889181|SUPERIORITY||Odds Ratio (OR)|0.82||||0.622|TWO_SIDED|95.0|0.38|1.78|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||1.78|0.38|0.6220
71685266|NCT04575584|142889182|SUPERIORITY||Odds Ratio (OR)|0.86||||0.7871|TWO_SIDED|95.0|0.28|2.6|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.60|0.28|0.7871
71758595|NCT03584789|143019498|SUPERIORITY||Odds Ratio (OR)|1.53||||0.62|TWO_SIDED|97.5|0.21|11.0|||Mixed Models Analysis|||||11.00|.21|.62
71877854|NCT02716675|143275174|OTHER||Prevention Efficacy (PE)|6.1|||||TWO_SIDED|95.0|-174.3|67.8||||||PE against IC80 of least sensitive variant 1-3||67.8|-174.3|
71877855|NCT02716675|143275174|OTHER||Prevention Efficacy (PE)|8.6|||||TWO_SIDED|95.0|-68.1|50.3||||||PE against IC80 of least sensitive variant \> 3||50.3|-68.1|
71877856|NCT01301456|143275201|SUPERIORITY_OR_OTHER||Least square (LS) mean|-21.16|STANDARD_ERROR_OF_MEAN|16.766||0.219|TWO_SIDED|80.0|-43.26|0.93|||Mixed meal tolerance test|||Day 30||0.93|-43.26|0.219
71877857|NCT01301456|143275201|SUPERIORITY_OR_OTHER||LS mean|-34.18|STANDARD_ERROR_OF_MEAN|15.189||0.034|TWO_SIDED|80.0|-54.2|-14.16|||Mixed meal tolerance test|||Day 30||-14.16|-54.20|0.034
71877858|NCT01301456|143275201|SUPERIORITY_OR_OTHER||LS mean|-33.67|STANDARD_ERROR_OF_MEAN|15.806||0.044|TWO_SIDED|80.0|-54.5|-12.84|||Mixed meal tolerance test|||Day 30||-12.84|-54.50|0.044
71877859|NCT01301456|143275201|SUPERIORITY_OR_OTHER||LS mean|-2.93|STANDARD_ERROR_OF_MEAN|16.111||0.857|TWO_SIDED|80.0|-24.16|18.31|||Mixed meal tolerance test|||Day 30||18.31|-24.16|0.857
71877860|NCT01301456|143275202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.251||0.419|TWO_SIDED|80.0|-0.54|0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.12|-0.54|0.419
71877861|NCT01301456|143275202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41|STANDARD_ERROR_OF_MEAN|0.224||0.077|TWO_SIDED|80.0|-0.71|-0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.12|-0.71|0.077
71877862|NCT01301456|143275202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.23||0.147|TWO_SIDED|80.0|-0.65|-0.04|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.04|-0.65|0.147
71877863|NCT01301456|143275202|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.244||0.086|TWO_SIDED|80.0|-0.76|-0.11|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.11|-0.76|0.086
71877864|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|4.11|STANDARD_ERROR_OF_MEAN|9.326||0.663|TWO_SIDED|80.0|-8.16|16.37|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||16.37|-8.16|0.663
71877865|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.89|STANDARD_ERROR_OF_MEAN|8.472||0.825|TWO_SIDED|80.0|-13.03|9.25|||mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.25|-13.03|0.825
71877866|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|1.36|STANDARD_ERROR_OF_MEAN|8.791||0.878|TWO_SIDED|80.0|-10.2|12.92|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.92|-10.20|0.878
71877867|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|0.72|STANDARD_ERROR_OF_MEAN|8.829||0.936|TWO_SIDED|80.0|-10.89|12.33|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||12.33|-10.89|0.936
71877868|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|13.037||0.959|TWO_SIDED|80.0|-16.46|17.82|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||17.82|-16.46|0.959
71877869|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-32.46|STANDARD_ERROR_OF_MEAN|11.872||0.011|TWO_SIDED|80.0|-48.07|-16.85|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-16.85|-48.07|0.011
71877870|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.61|STANDARD_ERROR_OF_MEAN|12.212||0.833|TWO_SIDED|80.0|-18.67|13.45|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.45|-18.67|0.833
71877871|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.21|STANDARD_ERROR_OF_MEAN|12.365||0.565|TWO_SIDED|80.0|-23.47|9.05|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.05|-23.47|0.565
71877872|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.75|STANDARD_ERROR_OF_MEAN|9.713||0.703|TWO_SIDED|80.0|-16.52|9.02|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||9.02|-16.52|0.703
71877873|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.46|STANDARD_ERROR_OF_MEAN|8.827||0.008|TWO_SIDED|80.0|-37.07|-13.85|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.85|-37.07|0.008
71877874|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.6|STANDARD_ERROR_OF_MEAN|9.061||0.253|TWO_SIDED|80.0|-22.51|1.32|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.32|-22.51|0.253
71877875|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.47|STANDARD_ERROR_OF_MEAN|9.198||0.128|TWO_SIDED|80.0|-26.57|-2.38|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-2.38|-26.57|0.128
71877876|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.15|STANDARD_ERROR_OF_MEAN|11.421||0.196|TWO_SIDED|80.0|-30.17|-0.13|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-0.13|-30.17|0.196
71685267|NCT04575584|142889182|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9598|TWO_SIDED|95.0|0.31|3.06|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||3.06|0.31|0.9598
71685268|NCT04575584|142889182|SUPERIORITY||Odds Ratio (OR)|0.79||||0.667|TWO_SIDED|95.0|0.27|2.31|||Wald Chi-Square||Based on the proportional odds model with WHO-11 score categories as the response variable. Due to sparse data, the final model includes only treatment as covariate. CIs are based on Wald Chi-Square Test.|||2.31|0.27|0.6670
71685269|NCT02815267|142889194|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.06||0.0083|TWO_SIDED|95.0|0.72|4.88|||ANCOVA|||Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.||4.88|0.72|0.0083
71685270|NCT02815267|142889195|SUPERIORITY||Risk Difference (RD)|3.33|STANDARD_ERROR_OF_MEAN|2.48||0.1805|TWO_SIDED|95.0|-1.54|8.19||P-value is for the null hypothesis that the combined risk difference equals 0.|Cochran-Mantel-Haenszel|||||8.19|-1.54|0.1805
71685271|NCT02815267|142889196|SUPERIORITY|Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.|Mean Difference (Final Values)|12.73|STANDARD_ERROR_OF_MEAN|4.42||0.004|TWO_SIDED|95.0|4.07|21.39|||ANCOVA|||||21.39|4.07|0.0040
71685272|NCT02815267|142889197|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|3.86|STANDARD_ERROR_OF_MEAN|1.03||0.0002|TWO_SIDED|95.0|1.85|5.87|||ANCOVA|||||5.87|1.85|0.0002
71877877|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.17|STANDARD_ERROR_OF_MEAN|10.393||0.012|TWO_SIDED|80.0|-41.84|-14.51|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-14.51|-41.84|0.012
71685273|NCT02815267|142889197|SUPERIORITY|Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.|Mean Difference (Final Values)|4.39|STANDARD_ERROR_OF_MEAN|1.03|<|0.0001|TWO_SIDED|95.0|2.38|6.4|||ANCOVA|||||6.40|2.38|<.0001
71685274|NCT02815267|142889198|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6|Risk Difference (RD)|2.71|STANDARD_ERROR_OF_MEAN|1.32||0.0395|TWO_SIDED|95.0|0.13|5.3|||Cochran-Mantel-Haenszel|||||5.3|0.13|0.0395
71685275|NCT02815267|142889198|SUPERIORITY|P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.|Risk Difference (RD)|2.76|STANDARD_ERROR_OF_MEAN|1.55||0.0748|TWO_SIDED|95.0|-0.28|5.8|||Cochran-Mantel-Haenszel|||||5.80|-0.28|0.0748
71877878|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-22.48|STANDARD_ERROR_OF_MEAN|10.773||0.047|TWO_SIDED|80.0|-36.65|-8.32|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-8.32|-36.65|0.047
71685276|NCT04278924|142889230|SUPERIORITY||Risk Difference (RD)|43.59|||=|0.056|TWO_SIDED|95.0|0.81|73.35|||Barnard's test||95% confidence interval (CI) of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.35|0.81|=0.056
71685277|NCT04278924|142889230|SUPERIORITY||Risk Difference (RD)|39.42|||=|0.088|TWO_SIDED|95.0|-4.24|71.38|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.38|-4.24|=0.088
71877879|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-28.63|STANDARD_ERROR_OF_MEAN|11.837||0.023|TWO_SIDED|80.0|-44.19|-13.06|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||-13.06|-44.19|0.023
71877880|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|5.08|STANDARD_ERROR_OF_MEAN|13.576||0.711|TWO_SIDED|80.0|-12.77|22.93|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||22.93|-12.77|0.711
71877881|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|5.4|STANDARD_ERROR_OF_MEAN|12.365||0.666|TWO_SIDED|80.0|-10.86|21.66|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||21.66|-10.86|0.666
71685278|NCT04278924|142889230|SUPERIORITY||Risk Difference (RD)|67.83|||=|0.001|TWO_SIDED|95.0|29.21|87.29|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||87.29|29.21|=0.001
71685279|NCT04278924|142889231|SUPERIORITY||Risk Difference (RD)|55.56|||=|0.001|TWO_SIDED|95.0|25.11|81.51|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||81.51|25.11|=0.001
71685280|NCT04278924|142889231|SUPERIORITY||Risk Difference (RD)|50.0|||=|0.004|TWO_SIDED|95.0|19.63|78.95|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.95|19.63|=0.004
71685281|NCT04278924|142889231|SUPERIORITY||Risk Difference (RD)|81.82|||<|0.001|TWO_SIDED|95.0|51.24|94.99|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||94.99|51.24|<0.001
71685282|NCT04278924|142889232|SUPERIORITY||Risk Difference (RD)|35.9|||=|0.12|TWO_SIDED|95.0|-7.22|67.75|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||67.75|-7.22|=0.120
71685283|NCT04278924|142889232|SUPERIORITY||Risk Difference (RD)|44.23|||=|0.06|TWO_SIDED|95.0|-0.83|73.77|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||73.77|-0.83|=0.060
71685284|NCT04278924|142889232|SUPERIORITY||Risk Difference (RD)|60.14|||=|0.003|TWO_SIDED|95.0|21.33|82.42|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||82.42|21.33|=0.003
71685285|NCT04278924|142889233|SUPERIORITY||Risk Difference (RD)|40.0|||=|0.187|TWO_SIDED|95.0|-16.28|78.17|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||78.17|-16.28|=0.187
71685286|NCT04278924|142889233|SUPERIORITY||Risk Difference (RD)|25.0|||=|0.315|TWO_SIDED|95.0|-28.85|71.78|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||71.78|-28.85|=0.315
71685287|NCT04278924|142889233|SUPERIORITY||Risk Difference (RD)|100.0|||=|0.004|TWO_SIDED|95.0|35.12|100.0|||Barnard's test||95% CI of the difference in percentage was calculated using Miettinen-Nurminen method.|||100.00|35.12|=0.004
71685288|NCT05600036|142889234|SUPERIORITY|||||||0.0025|||||||Cochran-Mantel-Haenszel|||||||0.0025
71685289|NCT05600036|142889234|SUPERIORITY|||||||0.0001|||||||Cochran-Mantel-Haenszel|||||||0.0001
71685290|NCT05600036|142889234|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71685291|NCT05600036|142889234|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71685292|NCT05600036|142889234|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71685293|NCT01006590|142889238|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.26|TWO_SIDED|95.0|-0.26|0.07|||ANCOVA|With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment||The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%||0.07|-0.26|0.26
71685294|NCT01006590|142889239|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.8|STANDARD_ERROR_OF_MEAN|5.79||0.3202|TWO_SIDED|95.0|-5.6|17.1|||Regression, Logistic|||||17.1|-5.6|0.3202
71685295|NCT01006590|142889240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|4.58||0.6203|TWO_SIDED|95.0|-6.7|11.3|||Regression, Logistic|||||11.3|-6.7|0.6203
71685296|NCT01006590|142889241|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.23||0.7627|TWO_SIDED|95.0|-0.38|0.52|||ANCOVA|||||0.52|-0.38|0.7627
71685297|NCT01006590|142889242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.19||0.7701|TWO_SIDED|95.0|-2.0|2.7|||ANCOVA|||||2.7|-2.0|0.7701
71877882|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.05|STANDARD_ERROR_OF_MEAN|12.333||0.807|TWO_SIDED|80.0|-19.27|13.17|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||13.17|-19.27|0.807
71685298|NCT01006590|142889243|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.39|STANDARD_ERROR_OF_MEAN|4.34||0.5882|TWO_SIDED|95.0|-6.22|10.93|||ANCOVA|||||10.93|-6.22|0.5882
71685299|NCT00703118|142889249|SUPERIORITY_OR_OTHER||Difference in percentage of response|46.8|||<|0.001|TWO_SIDED|95.0|36.8|56.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||56.7|36.8|<0.001
71685300|NCT00703118|142889249|SUPERIORITY_OR_OTHER||Difference in percentage of response|49.8|||<|0.001|TWO_SIDED|95.0|39.9|59.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.||59.7|39.9|<0.001
71685301|NCT03714776|142889263|SUPERIORITY||||||<|0.001||||||P-value of analysis of variance (ANOVA) with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||||||<0.001
71685302|NCT03714776|142889264|SUPERIORITY|||||||0.454||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.454
71685303|NCT03714776|142889264|SUPERIORITY|||||||0.909||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||0.909
71685304|NCT03714776|142889264|SUPERIORITY|||||||0.132||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||0.132
71685305|NCT03714776|142889264|SUPERIORITY|||||||0.659||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||0.659
71685306|NCT03714776|142889264|SUPERIORITY|||||||0.474||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||0.474
71685307|NCT03714776|142889264|SUPERIORITY|||||||0.483||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||0.483
71685308|NCT03714776|142889265|SUPERIORITY|||||||0.064||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 3||||0.064
71685309|NCT03714776|142889265|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 8||||<0.001
71918578|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|1.22||||0.16|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Multilevel Models|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 6-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.16
71918579|NCT04806165|143358606|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.01||||0.99|TWO_SIDED|||||"We interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.~We defined sufficiently large main effects as those with p values ≤ .05 or with 95% confidence intervals that do not include 0."|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the interaction effects of 14-week time since engagement with the intervention and the repeated administration (RA) component on participant willingness to seek psychotherapy for concerns related to their eating, weight, and/or shape concerns. since engagement with the intervention.||||0.99
71918580|NCT04806165|143358607|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.07|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||This analysis explores the time effect of attitudinal changes over the 14 week course of the study, regardless of the combination of components participants were assigned (ie., component turned off or on). Results will help determine whether mean participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns varied based on the time elapsed since engagement with the intervention (ie., do attitudinal changes post-inntervention endure over time?).||||<.001
71918581|NCT04806165|143358607|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.06|STANDARD_ERROR_OF_MEAN|0.03||0.026|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the motivational interviewing (MI) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.026
71685310|NCT03714776|142889265|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 15||||<0.001
71685311|NCT03714776|142889265|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 22||||<0.001
71685312|NCT03714776|142889265|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 29||||<0.001
71918582|NCT04806165|143358607|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.02|STANDARD_ERROR_OF_MEAN|0.03||0.465|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the personalized recommendation (PR) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.465
71918583|NCT04806165|143358607|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|-0.02|STANDARD_ERROR_OF_MEAN|0.03||0.536|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large.|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the psychoeducation (PE) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.536
71918584|NCT04806165|143358607|SUPERIORITY|To improve the quality of the imputations, gender, age, and race were included as auxiliary variables. We generated ten imputed datasets with the predictive mean matching method and pooled coefficients, degrees of freedom, and standard errors with Rubin's (1987) rules. As a sensitivity analysis, we also ran the same models using full information maximum likelihood to handle missing data.|Regression (Beta) Coefficient|0.06|STANDARD_ERROR_OF_MEAN|0.03||0.049|TWO_SIDED|||||We computed both unstandardized (B) and standardized (ß) coefficients to indicate effect sizes. As suggested by Fey et al. (2023), we interpreted absolute ß values below 0.2 as small, between 0.2 and 0.5 as medium, and greater than 0.5 as large|Linear Mixed Effects Model|The linear mixed effects models incorporated a random intercept to accommodate the correlation of repeated measures within participants.||Analyses were conducted to determine the interaction effects of time since intervention and each of the four chatbot components. This analysis explores the interaction effects of time and the repeated administration (RA) component on participant attitudes toward change for concerns related to their eating, weight, and/or shape concerns since engagement with the intervention.||||.049
71918585|NCT02776904|143358615|OTHER|||||||0.0003||||||Adjustment with Tukey-Kramer|ANOVA|3 DF||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory||||0.0003
71918586|NCT02776904|143358615|OTHER|||||||0.0281||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory||||0.0281
71918587|NCT02776904|143358615|OTHER|||||||0.0035||||||Adjusted for multiple comparisons|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite||||0.0035
71918588|NCT02776904|143358616|OTHER|||||||0.2637||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time||||0.2637
71918589|NCT02776904|143358617|OTHER||||||<|0.001||||||Used Tukey's Adjustment|ANOVA|||Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance)||||<0.001
71918590|NCT02776904|143358618|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey's post hoc method for the pairwise comparisons (0.05 threshold for significance).|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.||||||< 0.0001
71918591|NCT02776904|143358619|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pairwise comparisons with p\<.05.||||||< 0.0001
71918592|NCT02776904|143358620|OTHER|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.||||||< 0.0001
71918593|NCT02776904|143358621|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71918594|NCT02776904|143358622|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71918595|NCT02776904|143358623|OTHER||||||>|0.05|||||||ANOVA|||||||>0.05
71918596|NCT04657003|143358625|SUPERIORITY||LSMean Mean Difference (Net)|-10.1|||<|0.001|TWO_SIDED|95.0|-11.5|-8.8|||Mixed Models Analysis|||||-8.8|-11.5|<0.001
71918597|NCT04657003|143358625|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.7|-11.0|||Mixed Models Analysis|||||-11.0|-13.7|<0.001
71918598|NCT04657003|143358626|SUPERIORITY||Odds Ratio (OR)|10.75|||<|0.001|TWO_SIDED|95.0|7.3|15.84|||Regression, Logistic|||||15.84|7.30|<0.001
71877883|NCT01301456|143275204|SUPERIORITY_OR_OTHER||LS Mean Difference|6.79|STANDARD_ERROR_OF_MEAN|12.877||0.603|TWO_SIDED|80.0|-10.15|23.72|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||23.72|-10.15|0.603
71877884|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.48|STANDARD_ERROR_OF_MEAN|0.551||0.387|TWO_SIDED|80.0|-0.24|1.21|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.21|-0.24|0.387
71877885|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.52|STANDARD_ERROR_OF_MEAN|0.501||0.309|TWO_SIDED|80.0|-0.14|1.18|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.18|-0.14|0.309
71877886|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.518||0.956|TWO_SIDED|80.0|-0.71|0.65|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.65|-0.71|0.956
71877887|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.542||0.089|TWO_SIDED|80.0|0.24|1.67|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.67|0.24|0.089
71877888|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.73|STANDARD_ERROR_OF_MEAN|0.923||0.434|TWO_SIDED|80.0|-0.48|1.95|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.95|-0.48|0.434
71877889|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25|STANDARD_ERROR_OF_MEAN|0.841||0.15|TWO_SIDED|80.0|0.14|2.35|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.35|0.14|0.150
71877890|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.27|STANDARD_ERROR_OF_MEAN|0.861||0.752|TWO_SIDED|80.0|-0.86|1.41|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.41|-0.86|0.752
71877891|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.62|STANDARD_ERROR_OF_MEAN|0.888||0.492|TWO_SIDED|80.0|-0.55|1.79|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.79|-0.55|0.492
71877892|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.064||0.358|TWO_SIDED|80.0|-0.4|2.4|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.40|-0.40|0.358
71877893|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS mean Difference|1.6|STANDARD_ERROR_OF_MEAN|0.97||0.11|TWO_SIDED|80.0|0.33|2.88|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.33|0.110
71877894|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS mean Difference|0.74|STANDARD_ERROR_OF_MEAN|0.993||0.461|TWO_SIDED|80.0|-0.56|2.05|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.05|-0.56|0.461
71877895|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS mean Difference|1.11|STANDARD_ERROR_OF_MEAN|1.021||0.286|TWO_SIDED|80.0|-0.23|2.45|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.45|-0.23|0.286
71877896|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09|STANDARD_ERROR_OF_MEAN|1.172||0.362|TWO_SIDED|80.0|-0.45|2.63|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.63|-0.45|0.362
71877897|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.48|STANDARD_ERROR_OF_MEAN|1.069||0.179|TWO_SIDED|80.0|0.07|2.88|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.88|0.07|0.179
71877898|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.06|STANDARD_ERROR_OF_MEAN|1.092||0.342|TWO_SIDED|80.0|-0.38|2.49|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.49|-0.38|0.342
71877899|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.27|STANDARD_ERROR_OF_MEAN|1.129||0.272|TWO_SIDED|80.0|-0.22|2.75|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.75|-0.22|0.272
71877900|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|1.317||0.979|TWO_SIDED|80.0|-1.77|1.7|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||1.70|-1.77|0.979
71877901|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|1.201||0.568|TWO_SIDED|80.0|-2.27|0.88|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||0.88|-2.27|0.568
71877902|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|1.24|STANDARD_ERROR_OF_MEAN|1.201||0.311|TWO_SIDED|80.0|-0.34|2.82|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.82|-0.34|0.311
71918599|NCT04657003|143358626|SUPERIORITY||Odds Ratio (OR)|15.28|||<|0.001|TWO_SIDED|95.0|10.08|23.14|||Regression, Logistic|||||23.14|10.08|<0.001
71918600|NCT04657003|143358627|SUPERIORITY||Odds Ratio (OR)|20.94|||<|0.001|TWO_SIDED|95.0|13.06|33.58|||Regression, Logistic|||||33.58|13.06|<0.001
71918601|NCT04657003|143358627|SUPERIORITY||Odds Ratio (OR)|27.5|||<|0.001|TWO_SIDED|95.0|17.04|44.39|||Regression, Logistic|||||44.39|17.04|<0.001
71918602|NCT04657003|143358628|SUPERIORITY||Odds Ratio (OR)|28.38|||<|0.001|TWO_SIDED|95.0|13.81|58.31|||Regression, Logistic|||||58.31|13.81|<0.001
71918603|NCT04657003|143358628|SUPERIORITY||Odds Ratio (OR)|43.6|||<|0.001|TWO_SIDED|95.0|21.2|89.67|||Regression, Logistic|||||89.67|21.20|<0.001
71918604|NCT04657003|143358629|SUPERIORITY||Odds Ratio (OR)|28.54|||<|0.001|TWO_SIDED|95.0|9.73|83.73|||Regression, Logistic|||||83.73|9.73|<0.001
71918605|NCT04657003|143358629|SUPERIORITY||Odds Ratio (OR)|49.68|||<|0.001|TWO_SIDED|95.0|17.03|144.94|||Regression, Logistic|||||144.94|17.03|<0.001
71918606|NCT04657003|143358630|SUPERIORITY||LSMean Mean Difference (Net)|-10.3|||<|0.001|TWO_SIDED|95.0|-11.7|-8.8|||Mixed Models Analysis|||||-8.8|-11.7|<0.001
71918607|NCT04657003|143358630|SUPERIORITY||LSMean Mean Difference (Net)|-12.4|||<|0.001|TWO_SIDED|95.0|-13.8|-11.0|||Mixed Models Analysis|||||-11.0|-13.8|<0.001
71918608|NCT04657003|143358631|SUPERIORITY||LSMean Mean Difference (Net)|-3.7|||<|0.001|TWO_SIDED|95.0|-4.2|-3.2|||Mixed Models Analysis|||||-3.2|-4.2|<0.001
71918609|NCT04657003|143358631|SUPERIORITY||LSMean Mean Difference (Net)|-4.5|||<|0.001|TWO_SIDED|95.0|-5.0|-4.0|||Mixed Models Analysis|||||-4.0|-5.0|<0.001
71918610|NCT04657003|143358632|SUPERIORITY||LSMean Mean Difference (Net)|-1.97|||<|0.001|TWO_SIDED|95.0|-2.15|-1.8|||Mixed Models Analysis|||||-1.80|-2.15|<0.001
71918611|NCT04657003|143358632|SUPERIORITY||LSMean Mean Difference (Net)|-2.06|||<|0.001|TWO_SIDED|95.0|-2.24|-1.88|||Mixed Models Analysis|||||-1.88|-2.24|<0.001
71918612|NCT04657003|143358633|SUPERIORITY||Odds Ratio (OR)|28.01|||<|0.001|TWO_SIDED|95.0|17.21|45.59|||Regression, Logistic|||||45.59|17.21|<0.001
71918613|NCT04657003|143358633|SUPERIORITY||Odds Ratio (OR)|34.19|||<|0.001|TWO_SIDED|95.0|20.27|57.67|||Regression, Logistic|||||57.67|20.27|<0.001
71918614|NCT04657003|143358634|SUPERIORITY||Odds Ratio (OR)|42.11|||<|0.001|TWO_SIDED|95.0|25.61|69.26|||Regression, Logistic|||||69.26|25.61|<0.001
71918615|NCT04657003|143358634|SUPERIORITY||Odds Ratio (OR)|58.67|||<|0.001|TWO_SIDED|95.0|34.29|100.37|||Regression, Logistic|||||100.37|34.29|<0.001
71918616|NCT04657003|143358635|SUPERIORITY||Odds Ratio (OR)|42.55|||<|0.001|TWO_SIDED|95.0|20.46|88.5|||Regression, Logistic|||||88.50|20.46|<0.001
71918617|NCT04657003|143358635|SUPERIORITY||Odds Ratio (OR)|54.3|||<|0.001|TWO_SIDED|95.0|26.0|113.38|||Regression, Logistic|||||113.38|26.00|<0.001
71918618|NCT04657003|143358636|SUPERIORITY||LSMean Mean Difference (Net)|-46.79|||<|0.001|TWO_SIDED|95.0|-52.67|-40.91|||Mixed Models Analysis|||||-40.91|-52.67|<0.001
71918619|NCT04657003|143358636|SUPERIORITY||LSMean Mean Difference (Net)|-49.25|||<|0.001|TWO_SIDED|95.0|-55.18|-43.33|||Mixed Models Analysis|||||-43.33|-55.18|<0.001
71918620|NCT04657003|143358637|SUPERIORITY||LSMean Mean Difference (Net)|-7.8|||<|0.001|TWO_SIDED|95.0|-9.2|-6.4|||Mixed Models Analysis|||||-6.4|-9.2|<0.001
71918621|NCT04657003|143358637|SUPERIORITY||LSMean Mean Difference (Net)|-10.4|||<|0.001|TWO_SIDED|95.0|-11.8|-8.9|||Mixed Models Analysis|||||-8.9|-11.8|<0.001
71918622|NCT04657003|143358638|SUPERIORITY||Estimate Difference|-4.61|||<|0.001|TWO_SIDED|95.0|-7.11|-2.03|||Mixed Models Analysis|||||-2.03|-7.11|<0.001
71918623|NCT04657003|143358639|SUPERIORITY||Estimate Difference|-3.36||||0.112|TWO_SIDED|95.0|-7.36|0.81|||Mixed Models Analysis|||||0.81|-7.36|0.112
71918624|NCT04657003|143358640|SUPERIORITY||Estimate Difference|7.02|||<|0.001|TWO_SIDED|95.0|4.4|9.71|||Mixed Models Analysis|||||9.71|4.40|<0.001
71918625|NCT04657003|143358641|SUPERIORITY||Estimate Difference|-23.3|||<|0.001|TWO_SIDED|95.0|-27.5|-18.9|||Mixed Models Analysis|||||-18.9|-27.5|<0.001
71918626|NCT04657003|143358642|SUPERIORITY||Estimate Difference|-24.2|||<|0.001|TWO_SIDED|95.0|-28.6|-19.6|||Mixed Models Analysis|||||-19.6|-28.6|<0.001
71918627|NCT04657003|143358643|SUPERIORITY||Estimate Difference|-8.74|||<|0.001|TWO_SIDED|95.0|-12.04|-5.32|||Mixed Models Analysis|||||-5.32|-12.04|<0.001
71918628|NCT04657003|143358644|SUPERIORITY||Estimate Difference|-23.61|||<|0.001|TWO_SIDED|95.0|-28.62|-18.24|||Mixed Models Analysis|||||-18.24|-28.62|<0.001
71918629|NCT04657003|143358645|SUPERIORITY||LSMean Mean Difference (Net)|-6.2|||<|0.001|TWO_SIDED|95.0|-8.0|-4.4|||Mixed Models Analysis|||||-4.4|-8.0|<0.001
71918630|NCT04657003|143358646|SUPERIORITY||LSMean Mean Difference (Net)|-2.4|||<|0.001|TWO_SIDED|95.0|-3.5|-1.3|||Mixed Models Analysis|||||-1.3|-3.5|<0.001
71918631|NCT04657003|143358647|SUPERIORITY||Estimate Difference|-17.6|||<|0.001|TWO_SIDED|95.0|-25.5|-8.9|||Mixed Models Analysis|||||-8.9|-25.5|<0.001
71918632|NCT04657003|143358647|SUPERIORITY||Estimate Difference|-30.2|||<|0.001|TWO_SIDED|95.0|-37.0|-22.7|||Mixed Models Analysis|||||-22.7|-37.0|<0.001
71918633|NCT04657003|143358648|SUPERIORITY||LSMean Mean Difference (Net)|1.8||||0.001|TWO_SIDED|95.0|0.7|2.9|||ANCOVA|||||2.9|0.7|0.001
71918634|NCT04657003|143358648|SUPERIORITY||LSMean Mean Difference (Net)|2.3|||<|0.001|TWO_SIDED|95.0|1.1|3.4|||ANCOVA|||||3.4|1.1|<0.001
71918635|NCT04657003|143358649|SUPERIORITY||LSMean Difference (Net)|6.9|||<|0.001|TWO_SIDED|95.0|4.1|9.7|||ANCOVA|||||9.7|4.1|<0.001
71918636|NCT04657003|143358649|SUPERIORITY||LSMean Difference (Net)|7.8|||<|0.001|TWO_SIDED|95.0|5.0|10.7|||ANCOVA|||||10.7|5.0|<0.001
71918637|NCT01736176|143358651|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.||||< 0.001
71918638|NCT01736176|143358655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||||||0.004
71918639|NCT00598806|143358722|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1094|TWO_SIDED|95.0|0.55|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.55|0.1094
71918640|NCT00598806|143358723|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.1038|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.1038
71918641|NCT02607865|143358754|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
71918642|NCT02607865|143358754|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.4|-0.6|< 0.0001
71918643|NCT02607865|143358754|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
71918644|NCT02607865|143358754|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.4|< 0.0001
71918645|NCT02607865|143358754|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|0.2|||=|0.0856|TWO_SIDED|95.0|0.1|0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.1|= 0.0856
71922313|NCT00453349|143365041|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-2.5||||||95.0|-8.6|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||4.9|-8.6|
71877903|NCT01301456|143275206|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.26||0.71|TWO_SIDED|80.0|-1.18|2.13|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.||2.13|-1.18|0.710
71877904|NCT01380730|143275239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-66.1|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-71.48|-60.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-60.72|-71.48|<0.001
71877905|NCT01380730|143275239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-60.24|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-65.61|-54.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.88|-65.61|<0.001
71877906|NCT01380730|143275239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.82|STANDARD_ERROR_OF_MEAN|2.73|<|0.001|TWO_SIDED|95.0|-47.18|-36.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.45|-47.18|<0.001
71877907|NCT01380730|143275239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.33|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-56.04|-44.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.62|-56.04|<0.001
71877908|NCT01380730|143275239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.0|STANDARD_ERROR_OF_MEAN|2.89|<|0.001|TWO_SIDED|95.0|-55.69|-44.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-44.31|-55.69|<0.001
71877909|NCT01380730|143275239|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-41.84|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-47.55|-36.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-36.13|-47.55|<0.001
71877910|NCT01380730|143275240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.2|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-87.0|-71.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-71.5|-87.0|<0.001
71877911|NCT01380730|143275240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.4|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-85.2|-69.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-69.6|-85.2|<0.001
71877912|NCT01380730|143275240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.7|STANDARD_ERROR_OF_MEAN|4.0|<|0.001|TWO_SIDED|95.0|-58.5|-43.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.0|-58.5|<0.001
71877913|NCT01380730|143275240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.6|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.6|<0.001
71877914|NCT01380730|143275240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.1|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-68.5|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-53.7|-68.5|<0.001
71877915|NCT01380730|143275240|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.6|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-58.0|-43.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.1|-58.0|<0.001
71877916|NCT01380730|143275241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-61.4|STANDARD_ERROR_OF_MEAN|2.53|<|0.001|TWO_SIDED|95.0|-66.37|-56.43||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-56.43|-66.37|<0.001
71877917|NCT01380730|143275241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.42|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-60.37|-50.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-50.47|-60.37|<0.001
71877918|NCT01380730|143275241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.44|STANDARD_ERROR_OF_MEAN|2.52|<|0.001|TWO_SIDED|95.0|-43.39|-33.48||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-33.48|-43.39|<0.001
71877919|NCT01380730|143275241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.58|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-52.72|-42.44||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.44|-52.72|<0.001
71877920|NCT01380730|143275241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.8|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-50.92|-40.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-40.67|-50.92|<0.001
71877921|NCT01380730|143275241|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.79|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-42.94|-32.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-32.65|-42.94|<0.001
71877922|NCT01380730|143275242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.45|STANDARD_ERROR_OF_MEAN|2.46|<|0.001|TWO_SIDED|95.0|-61.28|-51.61||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-51.61|-61.28|<0.001
71877923|NCT01380730|143275242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.15|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-54.97|-45.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-45.33|-54.97|<0.001
71877924|NCT01380730|143275242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.74|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-39.56|-29.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.92|-39.56|<0.001
71877925|NCT01380730|143275242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.03|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-47.16|-36.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.90|-47.16|<0.001
71877926|NCT01380730|143275242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-40.77|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-45.88|-35.66||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-35.66|-45.88|<0.001
71877927|NCT01380730|143275242|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.38|STANDARD_ERROR_OF_MEAN|2.61|<|0.001|TWO_SIDED|95.0|-39.51|-29.25||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.25|-39.51|<0.001
71918646|NCT02607865|143358754|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|0.2|||=|0.008|TWO_SIDED|95.0|0.0|0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.3|0.0|= 0.0080
71685313|NCT03714776|142889265|SUPERIORITY||||||<|0.001||||||P-value of ANOVA with treatment and screening AGT concentration stratification factor was used for analysis.|ANOVA|||Day 36||||<0.001
71877928|NCT01380730|143275243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.74|STANDARD_ERROR_OF_MEAN|2.26|<|0.001|TWO_SIDED|95.0|-52.18|-43.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-43.29|-52.18|<0.001
71877929|NCT01380730|143275243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-43.38|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-47.81|-38.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-38.94|-47.81|<0.001
71877930|NCT01380730|143275243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-31.4|STANDARD_ERROR_OF_MEAN|2.25|<|0.001|TWO_SIDED|95.0|-35.83|-26.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-26.97|-35.83|<0.001
71685314|NCT02005627|142889267|SUPERIORITY||||||<|0.05||||||calculated|t-test, 2 sided|||||||<0.05
71685315|NCT02005627|142889270|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71877931|NCT01380730|143275243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.65|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-39.99|-31.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.32|-39.99|<0.001
71877932|NCT01380730|143275243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.97|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-40.29|-31.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-31.65|-40.29|<0.001
71877933|NCT01380730|143275243|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.73|STANDARD_ERROR_OF_MEAN|2.2|<|0.001|TWO_SIDED|95.0|-32.06|-23.39||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-23.39|-32.06|<0.001
71877934|NCT01380730|143275244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.44|STANDARD_ERROR_OF_MEAN|2.44|<|0.001|TWO_SIDED|95.0|-58.23|-48.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-48.65|-58.23|<0.001
71877935|NCT01380730|143275244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.3|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-52.08|-42.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-42.52|-52.08|<0.001
71877936|NCT01380730|143275244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.75|STANDARD_ERROR_OF_MEAN|2.43|<|0.001|TWO_SIDED|95.0|-39.53|-29.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-29.97|-39.53|<0.001
71877937|NCT01380730|143275244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.93|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-48.36|-37.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-37.50|-48.36|<0.001
71685316|NCT02005627|142889271|SUPERIORITY|||||||||||||||||Null Hypothesis was no difference between Grazax and Placebo treatment at 12 months. 80% power to detect 30% difference in total nasal symptom score (TNSS) after nasal challenge|Comparison of nasal symptom score at 0-60 mins after nasal challenge after 12 months treatment with Grazax compared to Placebo treatment. Mixed model analysis. 80% power to detect a 30% difference at p\<0.05.|||
71877938|NCT01380730|143275244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-42.4|STANDARD_ERROR_OF_MEAN|2.75|<|0.001|TWO_SIDED|95.0|-47.81|-36.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-36.98|-47.81|<0.001
71758596|NCT03584789|143019499|SUPERIORITY||Median Difference (Net)|-0.07||||0.38|TWO_SIDED|95.0|-0.26|0.12|||Mixed Models Analysis|||||.12|-0.26|.38
71877939|NCT01380730|143275244|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.77|STANDARD_ERROR_OF_MEAN|2.76|<|0.001|TWO_SIDED|95.0|-39.2|-28.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|||-28.33|-39.20|<0.001
71877940|NCT01312038|143275294|SUPERIORITY_OR_OTHER||||||=|0.93|||||||Paired T-test|df=34||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.||||=0.93
71758597|NCT03584789|143019499|SUPERIORITY||Median Difference (Net)|-0.03||||0.7|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|||||.17|-0.24|.70
71758598|NCT03584789|143019500|SUPERIORITY||Mean Difference (Net)|-0.14||||0.65|TWO_SIDED|95.0|-0.79|0.5|||Mixed Models Analysis|||||.50|-0.79|.65
71877941|NCT01312038|143275294|SUPERIORITY_OR_OTHER||||||=|0.39|||||||Paired T-test|df = 31||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.||||=0.39
71877942|NCT00823823|143275303|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.||||1.00
71877943|NCT04422990|143275310|NON_INFERIORITY|Noninferiority in mean CLCDVA was declared if the upper confidence limit was less than 0.10 logMAR.|Least squares mean difference|0.0|||||TWO_SIDED|95.0|-0.01|0.01||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Mixed effects repeated measures model||Least squares mean difference (LID018869 minus Biofinity).|||0.01|-0.01|
71877944|NCT04422990|143275311|NON_INFERIORITY|Proportion of subjects was used for the statistical analysis. Noninferiority in proportion of subjects achieving CLCDVA 20/20 or better in each eye was declared if the lower confidence limit was greater than -0.10.|Difference in proportion|-0.01|||||TWO_SIDED|95.0|-0.04|0.02||Since a noninferiority hypothesis is being tested, a p-value is not applicable. Confidence limit is being reported and compared to the noninferiority margin.|Generalized linear mixed model||Lens difference (LID018869 minus Biofinity)|||0.02|-0.04|
71877945|NCT05417607|143275326|SUPERIORITY||Mean Difference (Net)|3.75|STANDARD_DEVIATION|5.86||0.0047|TWO_SIDED|95.0|1.27|6.22|||t-test, 2 sided|||Within group pre- and post-intervention.||6.22|1.27|0.0047
71877946|NCT05417607|143275327|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_DEVIATION|7.9||0.2383|TWO_SIDED|95.0|-1.6|6.02|||t-test, 2 sided|||Within group pre- and post-intervention.||6.02|-1.6|0.2383
71877947|NCT05417607|143275328|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_DEVIATION|3.58||0.3426|TWO_SIDED|95.0|-2.22|0.8|||t-test, 2 sided|||Within group pre- and post-intervention.||0.80|-2.22|0.3426
71877948|NCT01750931|143275329|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.45||||0.4396|TWO_SIDED|95.0|99.4|105.59|||ANOVA|||||105.59|99.40|0.4396
71877949|NCT01750931|143275331|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|105.02||||0.9712|TWO_SIDED|95.0|99.69|110.63|||ANOVA||Comparison of AUC0-t between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||110.63|99.69|0.9712
71877950|NCT01750931|143275331|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.31||||0.9951|TWO_SIDED|95.0|99.05|105.69|||ANOVA||Comparison of AUC0-infinity between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg|||105.69|99.05|0.9951
71877951|NCT02790138|143275392|SUPERIORITY||Percentage Difference|21.6||||0.013|TWO_SIDED|95.0|4.9|37.5||The significance level was 0.05.|Fisher's Exact Test|||The Placebo IV and Vedolizumab IV 300 mg groups were analyzed using Fisher's Exact Test at Week 14.||37.5|4.9|0.013
71877952|NCT02790138|143275393|SUPERIORITY||Percentage Difference|17.6|||=|0.043|TWO_SIDED|95.0|0.3|35.1||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||||35.1|0.3|=0.043
71877953|NCT02790138|143275394|SUPERIORITY||Percentage Difference|25.5|||=|0.004|TWO_SIDED|95.0|8.0|41.4||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Fisher's Exact Test|||Week 14||41.4|8.0|=0.004
71685317|NCT00938587|142889272|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.291||0.0141|TWO_SIDED|90.0|-1.21|-0.24|||MMRM|||Day 14: Treatment difference and its corresponding 90 percent (%) confidence interval (CI) was based on least squares (LS) mean difference using mixed-model repeated measure (MMRM) where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and compound symmetry (CS) as covariance structure.||-0.24|-1.21|0.0141
71877954|NCT02790138|143275394|SUPERIORITY||Percentage Difference|19.6|||=|0.027|TWO_SIDED|95.0|1.9|37.0||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34.||37.0|1.9|=0.027
71877955|NCT02790138|143275395|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|1.7|9.4|||||Hazard ratio for achieving PDAI remission.|||9.4|1.7|
71877956|NCT02790138|143275396|SUPERIORITY||Percentage Difference|29.4|||=|0.003|TWO_SIDED|95.0|8.0|47.6||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 14||47.6|8.0|=0.003
71877957|NCT02790138|143275396|SUPERIORITY||Percentage Difference|21.6|||=|0.026|TWO_SIDED|95.0|1.9|39.8||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Chi-squared Test|||Week 34||39.8|1.9|=0.026
71877958|NCT02790138|143275397|SUPERIORITY||Odds Estimator|2.02|||=|0.002|TWO_SIDED|95.0|1.11|2.93||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.93|1.11|=0.002
71877959|NCT02790138|143275397|SUPERIORITY||Odds Estimator|1.71|||=|0.02|TWO_SIDED|95.0|0.92|2.49||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.49|0.92|=0.020
71877960|NCT02790138|143275398|SUPERIORITY||Odds Estimator|1.34|||=|0.191|TWO_SIDED|95.0|0.74|1.94||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.94|0.74|=0.191
71877961|NCT02790138|143275398|SUPERIORITY||Odds Estimator|1.07|||=|0.766|TWO_SIDED|95.0|0.6|1.54||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.54|0.60|=0.766
71685318|NCT00938587|142889272|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|0.283|<|0.0001|TWO_SIDED|90.0|-1.73|-0.79|||MMRM|||Day 14: Treatment difference and its corresponding 90 % CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.79|-1.73|<0.0001
71918647|NCT02607865|143358754|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
71918648|NCT02607865|143358754|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.5|-0.7|<0.0001
71918649|NCT02607865|143358754|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
71918650|NCT02607865|143358754|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.2|-0.4|<0.0001
71685319|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.865||0.437|TWO_SIDED|90.0|-4.54|1.63|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.63|-4.54|0.4370
71685320|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.858||0.1802|TWO_SIDED|90.0|-5.58|0.57|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.57|-5.58|0.1802
71685321|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|1.832||0.6012|TWO_SIDED|90.0|-3.99|2.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.07|-3.99|0.6012
71758599|NCT03584789|143019500|SUPERIORITY||Mean Difference (Net)|-0.29||||0.41|TWO_SIDED|95.0|-0.99|0.41|||Mixed Models Analysis|||||.41|-0.99|.41
71685322|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.01|STANDARD_ERROR_OF_MEAN|1.834||0.2753|TWO_SIDED|90.0|-5.04|1.03|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-5.04|0.2753
71877962|NCT02790138|143275399|SUPERIORITY||Odds Estimator|1.57|||=|0.055|TWO_SIDED|95.0|0.83|2.31||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.31|0.83|=0.055
71877963|NCT02790138|143275399|SUPERIORITY||Odds Estimator|1.48|||=|0.095|TWO_SIDED|95.0|0.79|2.16||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.16|0.79|=0.095
71877964|NCT02790138|143275400|SUPERIORITY||Odds Estimator|1.14|||=|0.575|TWO_SIDED|95.0|0.61|1.67||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||1.67|0.61|=0.575
71877965|NCT02790138|143275400|SUPERIORITY||Odds Estimator|1.21|||=|0.403|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.78|0.65|=0.403
71877966|NCT02790138|143275400|SUPERIORITY||Odds Estimator|1.6|||=|0.047|TWO_SIDED|95.0|0.85|2.34||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||2.34|0.85|=0.047
71877967|NCT02790138|143275401|SUPERIORITY||Odds Estimator|1.44|||=|0.119|TWO_SIDED|95.0|0.77|2.12||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 14||2.12|0.77|=0.119
71877968|NCT02790138|143275401|SUPERIORITY||Odds Estimator|1.15|||=|0.542|TWO_SIDED|95.0|0.62|1.69||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 22||1.69|0.62|=0.542
71877969|NCT02790138|143275401|SUPERIORITY||Odds Estimator|1.22|||=|0.404|TWO_SIDED|95.0|0.65|1.78||No multiplicity adjustment for inferential testing for secondary endpoints was preplanned, p-values from these tests are presented as nominal p-values. The significance level was 0.05.|Wilcoxon (Mann-Whitney)|P-value is from Wilcoxon Rank-sum Test comparing change from Baseline to relevant visits.Wilcoxon-Mann-Whitney odds estimator,95% CI are presented.||Change from Baseline at Week 34||1.78|0.65|=0.404
71877970|NCT01226459|143275409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.0|13.1|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.||13.1|5.0|<0.0001
71877971|NCT01226459|143275410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|7.0|14.7|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is of the change from baseline to week 12 data.||14.7|7.0|<0.0001
71877972|NCT01226459|143275411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.69|||<|0.0001|TWO_SIDED|95.0|0.35|1.04|||ANCOVA|||||1.04|0.35|<0.0001
71877973|NCT03770091|143275419|SUPERIORITY|ANOVA performed||||||0.6|||||||ANOVA|||||||0.6
71877974|NCT03770091|143275420|SUPERIORITY|||||||0.59|||||||ANOVA|||||||0.59
71877975|NCT03770091|143275421|SUPERIORITY|||||||0.9|||||||ANOVA|||||||0.9
71918651|NCT02607865|143358754|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||=|0.3851|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|=0.3851
71877976|NCT03770091|143275422|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
71877977|NCT03770091|143275423|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.5
71877978|NCT01092143|143275453|SUPERIORITY||Adjusted mean treatment differences|3.083|STANDARD_DEVIATION|1.65||0.0311|TWO_SIDED|95.0|-0.157|6.323||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.323|-0.157|0.0311
71877979|NCT01092143|143275453|SUPERIORITY||Adjusted mean treatment differences|3.589|STANDARD_DEVIATION|1.6||0.0126|TWO_SIDED|95.0|0.447|6.732||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, trea||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with placebo, after 6 weeks.||6.732|0.447|0.0126
71685323|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49|STANDARD_ERROR_OF_MEAN|1.844||0.7892|TWO_SIDED|90.0|-2.56|3.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.55|-2.56|0.7892
71685324|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.72|STANDARD_ERROR_OF_MEAN|1.937||0.3765|TWO_SIDED|90.0|-4.92|1.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.49|-4.92|0.3765
71685325|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.59|STANDARD_ERROR_OF_MEAN|1.873||0.0571|TWO_SIDED|90.0|-6.69|-0.49|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.49|-6.69|0.0571
71685326|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|1.896||0.6553|TWO_SIDED|90.0|-3.99|2.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.29|-3.99|0.6553
71685327|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.72|STANDARD_ERROR_OF_MEAN|1.847||0.1427|TWO_SIDED|90.0|-5.78|0.33|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.33|-5.78|0.1427
71877980|NCT01092143|143275453|SUPERIORITY||Adjusted mean treatment differences|3.977|STANDARD_DEVIATION|1.64||0.0078|TWO_SIDED|95.0|0.756|7.197||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with placebo, after 6 weeks.||7.197|0.756|0.0078
71877981|NCT01092143|143275453|OTHER||Adjusted mean treatment differences|8.619|STANDARD_DEVIATION|1.684|<|0.0001|TWO_SIDED|95.0|5.312|11.927||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with fluticasone propionate 110 mcg 2 puffs b.i.d. compared with those treated with placebo, after 6 weeks.||11.927|5.312|<.0001
71918652|NCT02607865|143358754|OTHER|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||<|0.0001|TWO_SIDED|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.4|0.1|<0.0001
71685328|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.87|STANDARD_ERROR_OF_MEAN|1.873||0.643|TWO_SIDED|90.0|-2.23|3.97|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.97|-2.23|0.6430
71685329|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.04|STANDARD_ERROR_OF_MEAN|1.918||0.5868|TWO_SIDED|90.0|-2.13|4.22|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.22|-2.13|0.5868
71685330|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|1.873||0.586|TWO_SIDED|90.0|-4.12|2.08|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-4.12|0.5860
71685331|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.84|STANDARD_ERROR_OF_MEAN|1.879||0.3288|TWO_SIDED|90.0|-1.27|4.95|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.95|-1.27|0.3288
71685332|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|1.846||0.9027|TWO_SIDED|90.0|-3.28|2.83|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.83|-3.28|0.9027
71685333|NCT00938587|142889273|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.8|STANDARD_ERROR_OF_MEAN|1.871||0.671|TWO_SIDED|90.0|-2.3|3.89|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.89|-2.30|0.6710
71685334|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.23|STANDARD_ERROR_OF_MEAN|1.123||0.837|TWO_SIDED|90.0|-1.63|2.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.09|-1.63|0.8370
71685335|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.96|STANDARD_ERROR_OF_MEAN|1.12||0.0819|TWO_SIDED|90.0|-3.81|-0.11|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.11|-3.81|0.0819
71877982|NCT01092143|143275453|SUPERIORITY||Adjusted mean treatment differences|-5.536|STANDARD_DEVIATION|1.653||0.9996|TWO_SIDED|95.0|-8.783|-2.29||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 50 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-2.290|-8.783|0.9996
71877983|NCT01092143|143275453|SUPERIORITY||Adjusted mean treatment differences|-5.03|STANDARD_DEVIATION|1.606||0.9991|TWO_SIDED|95.0|-8.185|-1.875||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 200 mg b.i.d. compared with those treated with fluticasone propionate 220mcg b.i.d., after 6 weeks.||-1.875|-8.185|0.9991
71918653|NCT02607865|143358755|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-2.0|-3.0|< 0.0001
71918654|NCT02607865|143358755|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-2.0|< 0.0001
71918655|NCT02607865|143358755|SUPERIORITY|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||=|0.0185|TWO_SIDED|95.0|-1.1|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-1.1|= 0.0185
71918656|NCT02607865|143358755|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.1|-2.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-2.1|-3.1|<0.0001
71918657|NCT02607865|143358755|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.1|-2.0|<0.0001
71918658|NCT02607865|143358755|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|type Mean treatment difference|-0.5|||=|0.0257|TWO_SIDED|95.0|-1.0|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-1.0|=0.0257
71918659|NCT02607865|143358776|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.34|||=|0.0063|TWO_SIDED|95.0|1.09|1.65||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.65|1.09|=0.0063
71918660|NCT02607865|143358776|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0.0221|TWO_SIDED|95.0|0.61|0.96||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.96|0.61|=0.0221
71918661|NCT02607865|143358776|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.68|0.41|<0.0001
71918662|NCT02607865|143358777|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33|||=|0.016|TWO_SIDED|95.0|1.05|1.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.68|1.05|=0.0160
71918663|NCT02607865|143358777|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.66|||=|0.0022|TWO_SIDED|95.0|0.51|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.51|=0.0022
71918664|NCT02607865|143358777|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31|||<|0.0001|TWO_SIDED|95.0|0.22|0.43||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.43|0.22|<0.0001
71918665|NCT01714336|143358813|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Regression, Logistic|||||||0.75
71918666|NCT01766401|143358816|SUPERIORITY||Least Squares Mean Difference|-1.5||||0.0438|TWO_SIDED|95.0|-2.96|-0.04|||MMRM|||||-0.04|-2.96|0.0438
71918667|NCT01766401|143358817|SUPERIORITY||Least Squares Mean Difference|-1.41||||0.0868|TWO_SIDED|95.0|-3.02|0.2|||MMRM|||||0.20|-3.02|0.0868
71918668|NCT01523613|143358818|SUPERIORITY|||||||0.262|||||||Fisher Exact|||||||0.262
71918669|NCT01523613|143358819|SUPERIORITY|||||||0.523|||||||Fisher Exact|||||||0.523
71918670|NCT01523613|143358820|SUPERIORITY|||||||0.1|||||||Fisher Exact|||||||0.100
71918671|NCT04623255|143358877|SUPERIORITY|||||||0.16|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in at least two inflammation markers' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.16
71918672|NCT04623255|143358878|SUPERIORITY|||||||0.606|TWO_SIDED|95.0|||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker CRP' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.606
71918673|NCT04623255|143358879|SUPERIORITY|||||||0.245|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker D-Dimer' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.245
71918674|NCT04623255|143358880|SUPERIORITY|||||||0.653|||||||Chi-squared|||The primary analysis will involve a comparison of the binary outcome '50% reduction in inflammation marker LDH' between the PEX and Standard of Care (control) trial arms using a chi-squared test. The risk difference (and ratio) will be estimated with a 95% confidence interval.||||0.653
71918675|NCT00998985|143358889|SUPERIORITY_OR_OTHER||Least Squares Mean (LSM) Difference|3.46|||||TWO_SIDED|90.0|2.89|4.03|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.03|2.89|
71918676|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|4.68|||||TWO_SIDED|90.0|4.11|5.25|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.25|4.11|
71918677|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|4.87|||||TWO_SIDED|90.0|4.3|5.44|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.44|4.30|
71918678|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|4.35|||||TWO_SIDED|90.0|3.78|4.92|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||4.92|3.78|
71918679|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|5.15|||||TWO_SIDED|90.0|4.58|5.72|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.72|4.58|
71918680|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|4.76|||||TWO_SIDED|90.0|4.19|5.33|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.33|4.19|
71918681|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|4.93|||||TWO_SIDED|90.0|4.36|5.5|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.50|4.36|
71918682|NCT00998985|143358889|SUPERIORITY_OR_OTHER||LSM Difference|5.34|||||TWO_SIDED|90.0|4.93|5.74|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10||5.74|4.93|
71918683|NCT00998985|143358890|SUPERIORITY_OR_OTHER||LSM Difference|2.25|||||TWO_SIDED|90.0|1.7|2.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||2.81|1.70|
71918684|NCT00998985|143358890|SUPERIORITY_OR_OTHER||LSM Difference|2.94|||||TWO_SIDED|90.0|2.38|3.49|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||3.49|2.38|
71918685|NCT00998985|143358890|SUPERIORITY_OR_OTHER||LSM Difference|3.84|||||TWO_SIDED|90.0|3.29|4.4|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.40|3.29|
71918686|NCT00998985|143358890|SUPERIORITY_OR_OTHER||LSM difference|4.98|||||TWO_SIDED|90.0|4.42|5.53|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||5.53|4.42|
71918687|NCT00998985|143358890|SUPERIORITY_OR_OTHER||LSM difference|4.21|||||TWO_SIDED|90.0|3.6|4.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10||4.81|3.60|
71918688|NCT01040728|143358897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.197|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.163|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.231|0.163|<0.0001
71918689|NCT01040728|143358897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.186|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.255|0.186|<0.0001
71918690|NCT01040728|143358897|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.221|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.187|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.255|0.187|<0.0001
71918691|NCT01040728|143358898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.153|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.117|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.188|0.117|<0.0001
71918692|NCT01040728|143358898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.134|0.205|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.205|0.134|<0.0001
71918693|NCT01040728|143358898|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.128|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.199|0.128|<0.0001
71918694|NCT01040728|143358899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.141|0.208|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.208|0.141|<0.0001
71918695|NCT01040728|143358899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.191|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.157|0.225|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.225|0.157|<0.0001
71918696|NCT01040728|143358899|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.192|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.159|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.226|0.159|<0.0001
71918697|NCT01040728|143358900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.181|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.248|0.181|<0.0001
71918698|NCT01040728|143358900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.205|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.272|0.205|<0.0001
71918699|NCT01040728|143358900|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.185|0.119|<0.0001
71918700|NCT01040728|143358901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.214|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.178|0.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.251|0.178|<0.0001
71918701|NCT01040728|143358901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.208|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.208|<0.0001
71918702|NCT01040728|143358901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.235|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.199|0.271|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.271|0.199|<0.0001
71918703|NCT01040728|143358902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.237|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.201|0.273|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.273|0.201|<0.0001
71918704|NCT01040728|143358902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.266|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.23|0.302|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.302|0.230|<0.0001
71685336|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|1.106||0.8892|TWO_SIDED|90.0|-1.98|1.67|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.67|-1.98|0.8892
71918705|NCT01040728|143358902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.138|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.211|0.138|<0.0001
71918706|NCT01040728|143358903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.169|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.246|0.169|<0.0001
71685337|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.35|STANDARD_ERROR_OF_MEAN|1.106||0.0353|TWO_SIDED|90.0|-4.17|-0.52|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.52|-4.17|0.0353
71918707|NCT01040728|143358903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.205|<0.0001
71918708|NCT01040728|143358903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.282|0.205|<0.0001
71918709|NCT01040728|143358904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.097|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.171|0.097|<0.0001
71918710|NCT01040728|143358904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.105|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.181|0.105|<0.0001
71877984|NCT01092143|143275453|SUPERIORITY||Adjusted mean treatment differences|-4.643|STANDARD_DEVIATION|1.647||0.9975|TWO_SIDED|95.0|-7.877|-1.408||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||Superiority in mean trough FEV1 % predicted change from baseline in patients treated with BI 671800 400 mg b.i.d. compared with those treated with fluticasone propionate 220 mcg b.i.d., after 6 weeks.||-1.408|-7.877|0.9975
71685338|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.39|STANDARD_ERROR_OF_MEAN|1.108||0.7283|TWO_SIDED|90.0|-2.22|1.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.45|-2.22|0.7283
71877985|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|0.073|STANDARD_DEVIATION|0.113||0.7413|TWO_SIDED|95.0|-0.149|0.295||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.295|-0.149|0.7413
71877986|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|-0.08|STANDARD_DEVIATION|0.11||0.2335|TWO_SIDED|95.0|-0.296|0.136||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.136|-0.296|0.2335
71877987|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|-0.061|STANDARD_DEVIATION|0.113||0.2933|TWO_SIDED|95.0|-0.282|0.16||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.160|-0.282|0.2933
71918711|NCT01040728|143358904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.195|0.120|<0.0001
71918712|NCT01040728|143358905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.276|0.384|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.384|0.276|<0.0001
71918713|NCT01040728|143358905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.326|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.272|0.381|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.381|0.272|<0.0001
71918714|NCT01040728|143358905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.316|0.424|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.424|0.316|<0.0001
71918715|NCT01040728|143358906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.278|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.214|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.342|0.214|<0.0001
71918716|NCT01040728|143358906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.264|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.2|0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.329|0.200|<0.0001
71918717|NCT01040728|143358906|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.238|0.366|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.366|0.238|<0.0001
71918718|NCT01040728|143358907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.304|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.244|0.363|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.363|0.244|<0.0001
71918719|NCT01040728|143358907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.283|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.222|0.343|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.343|0.222|<0.0001
71918720|NCT01040728|143358907|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.335|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.275|0.395|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.395|0.275|<0.0001
71918721|NCT01040728|143358908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.309|0.43|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.430|0.309|<0.0001
71918722|NCT01040728|143358908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.366|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.306|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.426|0.306|<0.0001
71918723|NCT01040728|143358908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.262|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.202|0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.322|0.202|<0.0001
71877988|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|-0.333|STANDARD_DEVIATION|0.116||0.0021|TWO_SIDED|95.0|-0.561|-0.105||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||-0.105|-0.561|0.0021
71877989|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|0.406|STANDARD_DEVIATION|0.114||0.9998|TWO_SIDED|95.0|0.183|0.63||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.630|0.183|0.9998
71877990|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|0.253|STANDARD_DEVIATION|0.11||0.989|TWO_SIDED|95.0|0.037|0.47||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.470|0.037|0.9890
71877991|NCT01092143|143275454|SUPERIORITY||Adjusted mean treatment differences|0.272|STANDARD_DEVIATION|0.113||0.9918|TWO_SIDED|95.0|0.05|0.494||α=0.025 one-sided|Mixed Models Analysis|MMRM with baseline, treatment, day, treatment by day interaction and baseline by day interaction as fixed effects and patient as a random effect.||||0.494|0.050|0.9918
71877992|NCT02774616|143275484|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0004|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0004
71877993|NCT02774616|143275485|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0019|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant \> 90.0%"||||0.0019
71877994|NCT02774616|143275487|NON_INFERIORITY|This endpoint evaluates the rate of appropriate right ventricular sensing of all patients in which a sensing measurement was performed. The following hypothesis has been defined: Ho: Rate of appropriate sensing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate sensing through 3 months post-implant \> 93.0%|||||<|0.0001||||||A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate sensing is greater than 93.0% in the population.|exact binomial|||||||<0.0001
71877995|NCT02774616|143275488|NON_INFERIORITY|A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate pacing is greater than 93.0% in the population.|||||<|0.0001|||||||exact binomial|||"This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant \> 93.0%"||||<0.0001
71877996|NCT00397033|143275490|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.001
71877997|NCT00397033|143275490|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.||||||0.008
71877998|NCT00397033|143275491|SUPERIORITY_OR_OTHER||LS Means Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.9|<|0.001||95.0|-5.1|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.7|-5.1|<0.001
71877999|NCT00397033|143275491|SUPERIORITY_OR_OTHER||LS Means Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.217||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.217
71878000|NCT00397033|143275492|SUPERIORITY_OR_OTHER||LS Means Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.6||0.108||95.0|-2.3|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-2.3|0.108
71878001|NCT00397033|143275492|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.43||95.0|-1.7|0.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.7|-1.7|0.430
71918724|NCT01040728|143358909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.344|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.287|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.401|0.287|<0.0001
71918725|NCT01040728|143358909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.296|0.411|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.411|0.296|<0.0001
71685339|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.14|STANDARD_ERROR_OF_MEAN|1.174||0.9083|TWO_SIDED|90.0|-1.81|2.08|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.08|-1.81|0.9083
71878002|NCT00397033|143275493|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.5||0.008||95.0|-6.7|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-6.7|0.008
71878003|NCT00397033|143275493|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|1.4||0.175||95.0|-4.8|0.9|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.9|-4.8|0.175
71878004|NCT00397033|143275494|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.9|STANDARD_ERROR_OF_MEAN|0.9||0.001||95.0|-4.6|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.1|-4.6|0.001
71878005|NCT00397033|143275494|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.9||0.209||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-2.8|0.209
71878006|NCT00397033|143275496|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.6||0.032||95.0|-6.5|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-6.5|0.032
71878007|NCT00397033|143275496|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.5||0.013||95.0|-6.8|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.8|-6.8|0.013
71878008|NCT00397033|143275497|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.232||95.0|-2.0|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-2.0|0.232
71918726|NCT01040728|143358909|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.029|<|0.0001||95.0|0.314|0.427|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.427|0.314|<0.0001
71918727|NCT01040728|143358910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.272|0.396|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.396|0.272|<0.0001
71918728|NCT01040728|143358910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.346|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001||95.0|0.283|0.408|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.408|0.283|<0.0001
71918729|NCT01040728|143358910|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.378|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001||95.0|0.316|0.44|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.440|0.316|<0.0001
71918730|NCT01040728|143358911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.244|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.179|0.309|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo|||0.309|0.179|<0.0001
71918731|NCT01040728|143358911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.216|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.15|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo|||0.282|0.150|<0.0001
71918732|NCT01040728|143358911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001||95.0|0.191|0.321|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo|||0.321|0.191|<0.0001
71918733|NCT02871570|143358964|OTHER||ratio|0.7789|||||TWO_SIDED|90.0|0.6514|0.9313|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9313|0.6514|
71918734|NCT02871570|143358965|OTHER||ratio|0.7776|||||TWO_SIDED|90.0|0.6493|0.9311|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||0.9311|0.6493|
71918735|NCT02871570|143358966|OTHER||ratio|1.2844|||||TWO_SIDED|90.0|1.0732|1.5372|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.5372|1.0732|
71878009|NCT00397033|143275497|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.31||95.0|-1.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.6|-1.8|0.310
71918736|NCT02871570|143358967|OTHER||ratio|0.7945|||||TWO_SIDED|90.0|0.5955|1.0599|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.|||1.0599|0.5955|
71918737|NCT02545049|143359006|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0264|TWO_SIDED|95.0|0.76|0.98||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.98|0.76|0.0264
71918738|NCT02545049|143359007|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.87||||0.0689|TWO_SIDED|95.0|0.76|1.01||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.01|0.76|0.0689
71685340|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.132||0.1641|TWO_SIDED|90.0|-3.45|0.29|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.29|-3.45|0.1641
71918739|NCT02545049|143359008|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.97||||0.3558|TWO_SIDED|95.0|0.9|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.90|0.3558
71918740|NCT02545049|143359009|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.89||||0.1337|TWO_SIDED|95.0|0.77|1.04||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||1.04|0.77|0.1337
71918741|NCT02545049|143359010|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Ratio of least squares means|0.676|||<|0.0001|TWO_SIDED|95.0|0.65|0.704||P-value from F-test of equal means between the treatment groups. A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|ANCOVA|||||0.704|0.650|<0.0001
71918742|NCT02545049|143359011|SUPERIORITY|If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.|Hazard Ratio (HR)|0.77||||0.0406|TWO_SIDED|95.0|0.6|0.99||A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.|Log Rank|Stratified log rank test|A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.|||0.99|0.60|0.0406
71918743|NCT01801189|143359012|SUPERIORITY|||||||0.1||||||Threshold for significance was P \<0.05.|t-test, 1 sided|||||||0.10
71918744|NCT01801189|143359012|SUPERIORITY|||||||0.23||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 1||||.23
71918745|NCT01801189|143359012|SUPERIORITY|||||||0.31||||||Threshold for significance \<0.05|t-test, 1 sided|||POD 2||||.31
71918746|NCT03958149|143359029|SUPERIORITY||||||<|0.001|||||||Independent t-test|||||||<0.001
71918747|NCT03958149|143359030|SUPERIORITY||||||<|0.05|||||||Factorial Mixed ANOVA|||||||<0.05
71918748|NCT00211536|143359060|NON_INFERIORITY_OR_EQUIVALENCE|For the average A1C, the goal was to show non-inferiority of MIP compared to SC. The minimal clinically relevant increase in A1C (%) was set at 0.50%. The between-subjects standard deviation of A1C was assumed to be 1.0% based on previous studies.|Least square means|0.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|ONE_SIDED|95.0||0.5|||Mixed Models Analysis|Repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed to compare A1C trends over time between the treatment groups||Sample size calculations were performed on the primary endpoint: the average glycosylated hemoglobin (A1C). Sample size was estimated using a two-sample, one-sided t-test with a significance level of 0.05. The projected sample size of 50 subjects per treatment group provides 79% power to reject the null hypothesis in favor of the alternative hypothesis that the average A1C in both the MIP and SC groups are equivalent, assuming an effect size of 0.50% and a standard deviation of 1.0%.||0.5||<0.05
71918749|NCT00003389|143359065|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.32
71918750|NCT00003389|143359066|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|TWO_SIDED||||||Log Rank|Stratified log rank test was performed.||||||0.86
71918751|NCT00908050|143359068|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|||||||Chi-squared|||The averaged data calculated from three nights in each recording period for each subject will be submitted to statistical analysis. Descriptive and non-parametric statistics will be used for the secondary end-points.||||0.0394
71918752|NCT00935766|143359101|SUPERIORITY_OR_OTHER|||||||0.21|||||||Mixed Models Analysis|||||||0.21
71918753|NCT00935766|143359102|SUPERIORITY_OR_OTHER|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71918754|NCT00935766|143359103|SUPERIORITY_OR_OTHER|||||||0.36|||||||Mixed Models Analysis|||||||0.36
71918755|NCT03347279|143359126|SUPERIORITY||Rate Ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.37|0.53|||Negative Binomial|||||0.53|0.37|<0.001
71918756|NCT03347279|143359127|SUPERIORITY||Rate Ratio|0.59|||<|0.001|TWO_SIDED|95.0|0.46|0.75|||Negative Binomial|||||0.75|0.46|<0.001
71685341|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.155||0.817|TWO_SIDED|90.0|-1.64|2.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.18|-1.64|0.8170
71878010|NCT00397033|143275498|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.6||0.004||95.0|-3.1|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.6|-3.1|0.004
71878011|NCT00397033|143275498|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.269||95.0|-1.9|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.9|0.269
71878012|NCT00397033|143275499|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6|<|0.001||95.0|-3.2|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-1.0|-3.2|<0.001
71878013|NCT00397033|143275499|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.314||95.0|-1.7|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.5|-1.7|0.314
71878014|NCT00397033|143275500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.071||95.0|-1.8|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.8|0.071
71878015|NCT00397033|143275500|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.5||0.099||95.0|-1.7|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.1|-1.7|0.099
71878016|NCT00397033|143275502|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-0.9|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-0.3|-0.9|<0.001
71918757|NCT03347279|143359128|SUPERIORITY||Least Squares (LS) Mean Difference|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.18|||Mixed Models Analysis|||||0.18|0.08|<0.001
71918758|NCT03347279|143359129|SUPERIORITY||LS Means Difference|0.33|||<|0.001|TWO_SIDED|95.0|0.2|0.47|||Mixed Models Analysis|||||0.47|0.2|<0.001
71918759|NCT03347279|143359130|SUPERIORITY||LS Means Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.46|-0.2|||Mixed Models Analysis|||||-0.2|-0.46|<0.001
71918760|NCT03347279|143359131|SUPERIORITY||LS Means Difference|-0.11||||0.004|TWO_SIDED|95.0|-0.19|-0.04|||Mixed Models Analysis|||||-0.04|-0.19|0.004
71918761|NCT02200510|143359160|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.33||||0.575|TWO_SIDED||||||ANOVA|||||||0.575
71685342|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.116||0.1958|TWO_SIDED|90.0|-3.29|0.4|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.40|-3.29|0.1958
71878017|NCT00397033|143275502|SUPERIORITY_OR_OTHER||LS Means Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.083||95.0|-0.6|0.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.6|0.083
71918762|NCT02200510|143359160|EQUIVALENCE|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.138||||0.721|TWO_SIDED||||||ANOVA|||||||0.721
71918763|NCT00474539|143359255|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.5||||||95.0|-3.3|2.0||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at \>=1:8 titer was calculated||2.0|-3.3|
71918764|NCT00474539|143359258|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.08|0.69|
71918765|NCT00474539|143359258|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.23||||||95.0|0.97|1.55||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||1.55|0.97|
71918766|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-3.5|2.0||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.0|-3.5|
71918767|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.9|1.7||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||1.7|-1.9|
71918768|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.2||||||95.0|-4.4|4.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||4.0|-4.4|
71878018|NCT00397033|143275503|SUPERIORITY_OR_OTHER||LS Means Difference|-8.3|STANDARD_ERROR_OF_MEAN|2.8||0.003||95.0|-13.8|-2.9||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||-2.9|-13.8|0.003
71878019|NCT00397033|143275503|SUPERIORITY_OR_OTHER||LS Means Difference|-3.6|STANDARD_ERROR_OF_MEAN|2.7||0.187||95.0|-9.0|1.8||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.||1.8|-9.0|0.187
71878020|NCT00397033|143275504|SUPERIORITY_OR_OTHER||LS Means Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001||95.0|-1.1|-0.4|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.|||-0.4|-1.1|<0.001
71878021|NCT00397033|143275504|SUPERIORITY_OR_OTHER||LS Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.029||95.0|-0.7|0.0|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.0|-0.7|0.029
71878022|NCT00397033|143275506|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.8|STANDARD_ERROR_OF_MEAN|1.6|<|0.001||95.0|-9.9|-3.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||-3.7|-9.9|<0.001
71878023|NCT00397033|143275506|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.5||0.066||95.0|-5.8|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|||0.2|-5.8|0.066
71878024|NCT01984164|143275507|SUPERIORITY||Treatment effect size|-13.6|||||TWO_SIDED|95.0|-23.6|-3.7|||||effect size p-value = 0.008|All analyses were conducted using the intention-to-treat principle. Results are provided as adjusted least-square means with SE and effect size (ES) estimates (calculated from mixed model with repeated measures (MMRM) as the adjusted difference in cognitive change between the 2 groups over the study period).||-3.7|-23.6|
71878025|NCT05293743|143275522|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.67||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.82.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by parent-reported brace logs.||||0.67
71878026|NCT05293743|143275522|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.23||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 3.70.||The null hypothesis is that there is no difference in brace adherence fractions between the control arm and the experimental arm during the study's intervention period. In this test, brace wear was measured by iButton temperature sensors.||||0.23
71878027|NCT05293743|143275523|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.86||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.68.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by parent-reported brace logs.||||0.86
71878028|NCT05293743|143275523|EQUIVALENCE|This analysis uses Welch's t-tests to calculate statistical significance, given the different variances and sample sizes of the populations.||||||0.21||||||The threshold for statistical significance was p = 0.05.|t-test, 2 sided|Degrees of Freedom = 6.94.||The null hypothesis is that there is no difference in brace adherence fractions when the experimental arm is wearing the Dynamic Bar versus the Standard Bar during the study period. In this test, brace wear was measured by iButton temperature sensors.||||0.21
71878029|NCT04376827|143275554|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.7807|TWO_SIDED|80.0|0.27|1.41|||log-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||1.41|0.27|0.7807
71878030|NCT04376827|143275555|SUPERIORITY||Hazard Ratio (HR)|1.52||||0.4654|TWO_SIDED|80.0|0.62|3.85|||long-rank test||Hazard ratio and 80% CI: estimated by Cox proportional hazards model adjusting for baseline UPCR level (\<3 mg/mg and \>=3 mg/mg).|||3.85|0.62|0.4654
71878031|NCT03227471|143275614|OTHER|||||||0.9943||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.9943
71878032|NCT03227471|143275614|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
71878033|NCT03227471|143275614|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||< 0.0001
71878034|NCT03227471|143275614|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
71878035|NCT03227471|143275615|OTHER|||||||0.8869||||||P value within treatment.|Mixed-effects model for repeated measure|||||||0.8869
71878036|NCT03227471|143275615|OTHER||||||<|0.0001||||||P value within treatment|Mixed-effects model for repeated measure|||||||<0.0001
71878037|NCT03227471|143275616|OTHER|||||||0.6407||||||P value within treatment|Mixed-effects model for repeated measure|||||||0.6407
71878038|NCT03227471|143275616|OTHER||||||<|0.0001||||||P value within treatment.|mixed-effects model for repeated measure|||||||<0.0001
71878039|NCT03227471|143275631|OTHER|||||||0.5802||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.5802
71878040|NCT03227471|143275631|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71878041|NCT03227471|143275631|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71878042|NCT03227471|143275631|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71918769|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-2.1|2.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.0|-2.1|
71918770|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.2|
71918771|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.2|
71918772|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.10 IU/mL threshold was calculated||2.2|-2.3|
71918773|NCT00474539|143359259|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at \>=0.01 IU/mL threshold was calculated||2.2|-2.3|
71918774|NCT00474539|143359260|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.72|1.03||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.03|0.72|
71918775|NCT00474539|143359260|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.74|1.12||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.12|0.74|
71918776|NCT00474539|143359260|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.93||||||95.0|0.78|1.1||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.78|
71918777|NCT00474539|143359260|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.24||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.24|0.81|
71918778|NCT00474539|143359263|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.6||||||95.0|-1.7|3.2||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.||3.2|-1.7|
71918779|NCT02061540|143359265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.841|STANDARD_ERROR_OF_MEAN|6.0373||0.0043|TWO_SIDED|95.0|-27.251|-2.432|||Wilcoxon's signed rank test|||Analysis was performed to compare baseline and endpoint data.||-2.432|-27.251|0.0043
71918780|NCT03442595|143359306|OTHER|test of difference in change of A1C between the two groups|||||<|0.001|||||||t-test, 2 sided|||The study was powered to detect a difference of 0.5% in the change in A1C with SD = 2 with 80\& at alopha = 0.;05 with a sample size of 128 in each group (paired t-test). The study reaches 100% power to detect this observed difference with an alpha level of 0.01.||||<0.001
71878043|NCT03227471|143275632|OTHER|||||||0.8712||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8712
71878044|NCT03227471|143275632|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
71878045|NCT03227471|143275633|OTHER|||||||0.8359||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.8359
71878046|NCT03227471|143275633|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
71878047|NCT03227471|143275634|OTHER|||||||0.9453||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.9453
71878048|NCT03227471|143275634|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71918781|NCT01642004|143359313|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.0002|TWO_SIDED|96.85|0.43|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel|||0.81|0.43|0.0002
71918782|NCT01603628|143359424|SUPERIORITY||Least Squares (LS) Mean Difference|-0.26||||0.01|TWO_SIDED|95.0|-0.453|-0.063||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.063|-0.453|0.010
71918783|NCT01603628|143359424|SUPERIORITY||LS Mean Difference|-0.21||||0.033|TWO_SIDED|95.0|-0.405|-0.018||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||-0.018|-0.405|0.033
71878049|NCT03227471|143275634|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71878050|NCT03227471|143275634|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71878051|NCT03227471|143275635|OTHER|||||||0.7849||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7849
71878052|NCT03227471|143275635|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
71878053|NCT03227471|143275636|OTHER|||||||0.7356||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.7356
71878054|NCT03227471|143275636|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
71878055|NCT03227471|143275637|OTHER|||||||0.394||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.3940
71878056|NCT03227471|143275637|OTHER|||||||0.0003||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||0.0003
71878057|NCT03227471|143275637|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71878058|NCT03227471|143275637|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|Mixed-effects model for repeated measure|||||||<0.0001
71878059|NCT03227471|143275638|OTHER|||||||0.4757||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.4757
71878060|NCT03227471|143275638|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
71878061|NCT03227471|143275639|OTHER|||||||0.007||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||0.0070
71878062|NCT03227471|143275639|OTHER||||||<|0.0001||||||P value within treatment. These are nominal p-values without multiplicity control.|mixed-effects model for repeated measure|||||||<0.0001
71878063|NCT00525044|143275696|OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.028||0.0156|TWO_SIDED|95.0|-0.12|-0.01|||ANOVA||Treatment differences (Ambroxol- Placebo)|"Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.01|-0.12|0.0156
71878064|NCT00525044|143275697|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0|-0.4|0.1280
71878065|NCT00525044|143275697|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
71878066|NCT00525044|143275697|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
71878067|NCT00525044|143275697|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
71918784|NCT01603628|143359425|SUPERIORITY||LS Mean Difference|0.29||||0.023|TWO_SIDED|95.0|0.04|0.532||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.532|0.040|0.023
71918785|NCT01603628|143359425|SUPERIORITY||LS Mean Difference|0.13||||0.299|TWO_SIDED|95.0|-0.115|0.374||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures|||||0.374|-0.115|0.299
71918786|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.41||||0.005|TWO_SIDED|95.0|0.126|0.704||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.704|0.126|0.005
71918787|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.29||||0.047|TWO_SIDED|95.0|0.004|0.573||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.573|0.004|0.047
71918788|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.45||||0.004|TWO_SIDED|95.0|0.145|0.756||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.756|0.145|0.004
71918789|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.44||||0.004|TWO_SIDED|95.0|0.141|0.74||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.740|0.141|0.004
71918790|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.49||||0.001|TWO_SIDED|95.0|0.191|0.797||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.797|0.191|0.001
71918791|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.22||||0.153|TWO_SIDED|95.0|-0.081|0.541||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.541|-0.081|0.153
71918792|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.41||||0.01|TWO_SIDED|95.0|0.1|0.711||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.711|0.100|0.010
71918793|NCT01603628|143359426|SUPERIORITY||LS Mean Difference|0.27||||0.078|TWO_SIDED|95.0|-0.031|0.571||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.571|-0.031|0.078
71918794|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-1.99||||0.158|TWO_SIDED|95.0|-4.768|0.779||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||0.779|-4.768|0.158
71918795|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-3.25||||0.02|TWO_SIDED|95.0|-5.974|-0.524||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2||-0.524|-5.974|0.020
71918796|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-1.42||||0.363|TWO_SIDED|95.0|-4.489|1.648||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||1.648|-4.489|0.363
71918797|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-2.11||||0.171|TWO_SIDED|95.0|-5.127|0.914||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4||0.914|-5.127|0.171
71918798|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-3.33||||0.02|TWO_SIDED|95.0|-6.143|-0.525||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-0.525|-6.143|0.020
71918799|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-3.92||||0.006|TWO_SIDED|95.0|-6.688|-1.148||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6||-1.148|-6.688|0.006
71918800|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-2.07||||0.254|TWO_SIDED|95.0|-5.621|1.491||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.491|-5.621|0.254
71918801|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-2.46||||0.165|TWO_SIDED|95.0|-5.935|1.014||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8||1.014|-5.935|0.165
71918802|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-2.61||||0.078|TWO_SIDED|95.0|-5.517|0.296||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||0.296|-5.517|0.078
71918803|NCT01603628|143359427|SUPERIORITY||LS Mean Difference|-1.09||||0.451|TWO_SIDED|95.0|-3.944|1.758||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12||1.758|-3.944|0.451
71918804|NCT04107935|143359448|SUPERIORITY|||||||0.983||||||Propensity score matching was used to form pairs of intervention and control participants. Specifically, a greedy matching procedure with a matching caliper of 0.2 of the standard deviation of the logit of the propensity score was used.|Mixed Models Analysis|Since baseline characteristics achieved a good balance, those variables were not entered into the propensity score matched model.||||||0.9830
71918805|NCT04107935|143359449|SUPERIORITY|||||||0.8365||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.8365
71918806|NCT04107935|143359450|SUPERIORITY|||||||0.5727||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.5727
71918807|NCT04107935|143359451|SUPERIORITY|||||||0.9381||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.9381
71918808|NCT04107935|143359453|SUPERIORITY|||||||0.608||||||Adjusted for age, race, body mass index, and time|Mixed Models Analysis|||||||0.608
71918809|NCT01021553|143359454|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.16||||0.4959|TWO_SIDED|95.0|0.75|1.79|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.79|0.75|0.4959
71918810|NCT01021553|143359454|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.11||||0.6161|TWO_SIDED|95.0|0.74|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.74|0.6161
71918811|NCT01021553|143359454|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.13||||0.4971|TWO_SIDED|95.0|0.79|1.61|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.61|0.79|0.4971
71918812|NCT01021553|143359455|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.9037|TWO_SIDED|95.0|0.67|1.58|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.58|0.67|0.9037
71918813|NCT01021553|143359455|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.0||||0.9939|TWO_SIDED|95.0|0.67|1.48|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4||1.48|0.67|0.9939
71918814|NCT01021553|143359455|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.01||||0.9541|TWO_SIDED|95.0|0.71|1.43|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 0-4||1.43|0.71|0.9541
71918815|NCT01021553|143359455|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.33||||0.2798|TWO_SIDED|95.0|0.79|2.24|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||2.24|0.79|0.2798
71918816|NCT01021553|143359455|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.09||||0.7255|TWO_SIDED|95.0|0.68|1.75|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.75|0.68|0.7255
71918817|NCT01021553|143359455|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.18||||0.4347|TWO_SIDED|95.0|0.77|1.8|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8||1.80|0.77|0.4347
71918818|NCT01021553|143359456|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.14||||0.6583|TWO_SIDED|95.0|0.63|2.05|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||2.05|0.63|0.6583
71918819|NCT01021553|143359456|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|0.96||||0.879|TWO_SIDED|95.0|0.56|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.65|0.56|0.8790
71918820|NCT01021553|143359456|SUPERIORITY_OR_OTHER||Geometric LS Mean Fold Difference|1.03||||0.8971|TWO_SIDED|95.0|0.64|1.67|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|||1.67|0.64|0.8971
71918821|NCT01021553|143359459|SUPERIORITY_OR_OTHER||Ratio of treatments|2.91|||||TWO_SIDED|90.0|2.43|3.48|||||For AUC (0-inf)|||3.48|2.43|
71918822|NCT01021553|143359459|SUPERIORITY_OR_OTHER||Ratio of treatments|2.98|||||TWO_SIDED|90.0|2.51|3.54||||||||3.54|2.51|
71918823|NCT01021553|143359460|SUPERIORITY_OR_OTHER||Ratio of treatments|3.63|||||TWO_SIDED|90.0|2.95|4.47||||||||4.47|2.95|
71918824|NCT00033293|143359469|OTHER||Chi-squared test statistic|8.125||||0.0044|TWO_SIDED|95.0||||No adjustments for multiple comparisons.|Chi-squared|A two-way test with a null hypothesis of no association, using SAS 9.4.||"The 5 categories of OMA ratings are: stance, gait, arm \& hand function, opsoclonus, \& mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the best of 3 time points: 2 months, 6 months \& 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test."||||0.0044
71918825|NCT00033293|143359470|OTHER||Mean Difference (Net)|60.1979||||0.0919|ONE_SIDED||||||t-test, 1 sided|||The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.||||0.0919
71878068|NCT00525044|143275698|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.128|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.1280
71878069|NCT00525044|143275698|OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0417|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.4|0.0417
71878070|NCT00525044|143275698|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0054|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||-0.1|-0.6|0.0054
71878071|NCT00525044|143275698|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0201|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."||0.0|-0.6|0.0201
71878072|NCT00525044|143275699|OTHER|||||||0.9939|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.9939
71878073|NCT00525044|143275699|OTHER|||||||0.5552|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.5552
71878074|NCT00525044|143275700|OTHER|||||||0.0343|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0343
71878075|NCT00525044|143275700|OTHER|||||||0.0119|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."||||0.0119
71878076|NCT02665052|143275772|SUPERIORITY|||||||0.64||||||The primary analysis was a two sample t-test (alpha=0.05) of the mean WMFT log-time change at 6 weeks. The threshold for statistical significance was p-value = 0.05.|t-test, 2 sided|||78 participants were needed to generate a sample size of 22 per group and provide 80% power to detect a between group difference in mean Wolf time change (6 week - baseline) based on an a priori assumption of a mean change of 0 and 7.4 seconds respectively for the delayed entry usual care control and home-based BATRAC group; a SD of 7.6 and discontinuation rate of 15%.||||0.64
71878077|NCT02665052|143275773|SUPERIORITY|||||||0.01||||||The lab-based group had significant within group mean Fugl-Meyer (FM) change at week 6.|ANOVA|Dunnett's adjustments were used to compare the active intervention changes to the delayed-entry usual care control group.||Within group changes from baseline to week 6 were assessed using analysis of variance.||||0.01
71878078|NCT02665052|143275773|SUPERIORITY|||||||0.97|||||||ANOVA|||FM change was analyzed using analysis of variance followed by Dunnett's adjustment for between group comparisons in the home-based BATRAC group compared to the delayed-entry control.||||0.97
71878079|NCT02665052|143275774|SUPERIORITY|||||||0.31|||||||ANOVA|||Within group SIS hand changes from baseline to week 6 were assessed using analysis of variance followed by comparisons to the delayed-entry usual care control using Dunnett's adjustment.||||0.31
71878080|NCT02234284|143275775|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.35|TWO_SIDED|95.0|-0.15|0.43|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.43|-.15|.35
71878081|NCT02234284|143275776|SUPERIORITY||Mean Difference (Net)|0.26||||0.2|TWO_SIDED|95.0|-0.13|0.65|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.65|-.13|.20
71878082|NCT02234284|143275777|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.13|TWO_SIDED|95.0|-0.49|0.07|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.07|-0.49|.13
71882624|NCT02706873|143284639|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.88|||<|0.001|TWO_SIDED|95.0|-1.09|-0.67||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.||||-0.67|-1.09|<0.001
71685343|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.13|STANDARD_ERROR_OF_MEAN|1.13||0.907|TWO_SIDED|90.0|-1.74|2.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.00|-1.74|0.9070
71685344|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.58|STANDARD_ERROR_OF_MEAN|1.16||0.0023|TWO_SIDED|90.0|1.67|5.5|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.50|1.67|0.0023
71685345|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.62|STANDARD_ERROR_OF_MEAN|1.132||0.1531|TWO_SIDED|90.0|-0.25|3.49|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.49|-0.25|0.1531
71685346|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.65|STANDARD_ERROR_OF_MEAN|1.141||0.1506|TWO_SIDED|90.0|-0.24|3.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.53|-0.24|0.1506
71878083|NCT02234284|143275778|SUPERIORITY||Mean Difference (Final Values)|8.53||||0.32|TWO_SIDED|95.0|-8.18|25.26|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.|25.26|-8.18|.32
71685347|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|1.116||0.78|TWO_SIDED|90.0|-2.16|1.53|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.53|-2.16|0.7800
71878084|NCT02234284|143275779|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.27|TWO_SIDED|95.0|-0.23|0.83|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.83|-.23|.27
71878085|NCT02234284|143275780|SUPERIORITY||Mean Difference (Final Values)|0.38||||0.02|TWO_SIDED|95.0|0.07|0.68|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||.68|.07|.02
71878086|NCT02234284|143275781|SUPERIORITY||Mean Difference (Final Values)|-0.83||||0.4|TWO_SIDED|95.0|-2.78|1.12|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.12|-2.78|.40
71878087|NCT02234284|143275782|SUPERIORITY||Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-3.0|3.0|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||3|-3|.98
71878088|NCT02234284|143275783|SUPERIORITY||Mean Difference (Final Values)|-11.5||||0.3|TWO_SIDED|95.0|-33.3|10.2|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||10.2|-33.3|.30
71878089|NCT02234284|143275784|SUPERIORITY||Mean Difference (Final Values)|-0.73||||0.29|TWO_SIDED|95.0|-2.07|0.62|||Mixed Models Analysis||Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|||0.62|-2.07|.29
71685348|NCT00938587|142889274|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|1.13||0.0883|TWO_SIDED|90.0|-3.8|-0.07|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-3.80|0.0883
71878090|NCT02234284|143275785|SUPERIORITY||Mean Difference (Final Values)|39.7|||<|0.001|TWO_SIDED|95.0|19.6|59.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||59.8|19.6|<.001
71685349|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.47|STANDARD_ERROR_OF_MEAN|4.48||0.0599|TWO_SIDED|90.0|-15.87|-1.07|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-1.07|-15.87|0.0599
71878091|NCT02234284|143275786|SUPERIORITY||Mean Difference (Final Values)|7.8||||0.38|TWO_SIDED|95.0|-9.5|25.2|||Mixed Models Analysis||Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.2|-9.5|.38
71878092|NCT02234284|143275787|SUPERIORITY||Median Difference (Final Values)|2.0||||0.73|TWO_SIDED|95.0|-9.4|13.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||13.4|-9.4|.73
71878093|NCT02234284|143275788|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.7|TWO_SIDED|95.0|-14.0|20.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||20.8|-14.0|.70
71878094|NCT02234284|143275789|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.97|TWO_SIDED|95.0|-5.5|5.3|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||5.3|-5.5|.97
71878095|NCT02234284|143275790|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.52|TWO_SIDED|95.0|-0.32|1.28|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||1.28|-0.32|.52
71878096|NCT02234284|143275791|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.78|TWO_SIDED|95.0|-0.32|0.22|||Mixed Models Analysis||Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.22|-0.32|.78
71878097|NCT02234284|143275792|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.8|TWO_SIDED|95.0|-0.56|0.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.40|-0.56|.80
71918826|NCT00033293|143359471|OTHER|The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|Mean Difference (Net)|16.75||||0.2364|ONE_SIDED||||||t-test, 1 sided|||||||0.2364
71918827|NCT00935701|143359482|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Restless-Impulsive subscale||||0.01
71882625|NCT02706873|143284639|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-1.01|||<|0.001|TWO_SIDED|95.0|-1.21|-0.8||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.80|-1.21|<0.001
71882626|NCT02706873|143284640|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.25||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.25|-0.44|<0.001
71685350|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.29|STANDARD_ERROR_OF_MEAN|4.436||0.003|TWO_SIDED|90.0|-20.61|-5.96|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.96|-20.61|0.0030
71685351|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.63|STANDARD_ERROR_OF_MEAN|4.483||0.0053|TWO_SIDED|90.0|-20.03|-5.22|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.22|-20.03|0.0053
71685352|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.44|STANDARD_ERROR_OF_MEAN|4.445||0.0001|TWO_SIDED|90.0|-24.78|-10.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-10.10|-24.78|0.0001
71685353|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.15|STANDARD_ERROR_OF_MEAN|4.427||0.3492|TWO_SIDED|90.0|-11.46|3.16|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.16|-11.46|0.3492
71878098|NCT02234284|143275793|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.35|TWO_SIDED|95.0|-0.32|0.06|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.06|-0.32|.35
71685354|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.68|STANDARD_ERROR_OF_MEAN|4.661||0.0389|TWO_SIDED|90.0|-17.38|-1.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure||-1.98|-17.38|0.0389
71685355|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.1|STANDARD_ERROR_OF_MEAN|4.49||0.0142|TWO_SIDED|90.0|-18.51|-3.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-3.68|-18.51|0.0142
71685356|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.51|STANDARD_ERROR_OF_MEAN|4.612||0.0037|TWO_SIDED|90.0|-21.13|-5.89|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.89|-21.13|0.0037
71878099|NCT02234284|143275794|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.37|TWO_SIDED|95.0|-0.2|0.04|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||0.04|-0.20|.37
71918828|NCT00935701|143359482|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Emotional Lability subscale||||0.09
71918829|NCT00935701|143359482|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Global Index Total||||0.02
71918830|NCT00935701|143359482|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Inattentive subscale||||0.01
71918831|NCT00935701|143359482|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Hyperactive-Impulsive subscale||||0.03
71918832|NCT00935701|143359482|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Total||||0.01
71918833|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Bedtime Resistance subscale||||0.08
71918834|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Onset Delay subscale||||0.03
71918835|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Duration subscale||||0.82
71918836|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Anxiety subscale||||0.58
71918837|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Night Wakings subscale||||0.66
71918838|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parasomnias subscale||||0.18
71918839|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Daytime Sleepiness subscale||||0.31
71918840|NCT00935701|143359483|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Disturbance||||0.07
71918841|NCT00935701|143359484|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Child Domain Total||||0.04
71918842|NCT00935701|143359484|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parent Domain Total||||0.31
71685357|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-14.93|STANDARD_ERROR_OF_MEAN|4.447||0.0009|TWO_SIDED|90.0|-22.27|-7.58|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-7.58|-22.27|0.0009
71685358|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.83|STANDARD_ERROR_OF_MEAN|4.484||0.3939|TWO_SIDED|90.0|-11.23|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-11.23|0.3939
71685359|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.54|STANDARD_ERROR_OF_MEAN|4.595||0.0127|TWO_SIDED|90.0|3.95|19.13|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||19.13|3.95|0.0127
71685360|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|4.49||0.9425|TWO_SIDED|90.0|-7.09|7.74|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.74|-7.09|0.9425
71685361|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|11.08|STANDARD_ERROR_OF_MEAN|4.544||0.0155|TWO_SIDED|90.0|3.58|18.59|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||18.59|3.58|0.0155
71685362|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|4.447||0.9757|TWO_SIDED|90.0|-7.48|7.21|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.21|-7.48|0.9757
71918843|NCT00935701|143359484|SUPERIORITY_OR_OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Stress||||0.07
71685363|NCT00938587|142889275|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|4.484||0.9184|TWO_SIDED|90.0|-7.86|6.94|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||6.94|-7.86|0.9184
71685364|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2403|TWO_SIDED|90.0|-0.38|0.06|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.38|0.2403
71685365|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.134||0.027|TWO_SIDED|90.0|-0.52|-0.08|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.08|-0.52|0.0270
71685366|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.133||0.3139|TWO_SIDED|90.0|-0.36|0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.09|-0.36|0.3139
71685367|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.28|STANDARD_ERROR_OF_MEAN|0.134||0.0415|TWO_SIDED|90.0|-0.5|-0.05|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.05|-0.50|0.0415
71685368|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.134||0.8585|TWO_SIDED|90.0|-0.2|0.25|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.25|-0.20|0.8585
71685369|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.138||0.7284|TWO_SIDED|90.0|-0.28|0.18|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.18|-0.28|0.7284
71685370|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.0171|TWO_SIDED|90.0|-0.55|-0.1|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.10|-0.55|0.0171
71685371|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.135||0.2277|TWO_SIDED|90.0|-0.39|0.06|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.06|-0.39|0.2277
71918844|NCT02176005|143359496|OTHER||Contrast (B/A)|0.0093|||<|1e-06|TWO_SIDED|95.0|0.006|0.0144|||General linear model|||||0.0144|0.0060|<.000001
71918845|NCT02176005|143359497|OTHER||Contrast (B/A)|0.0096|||<|1e-06|TWO_SIDED|95.0|0.0061|0.0151|||General linear model|||||0.0151|0.0061|<.000001
71918846|NCT02176005|143359498|OTHER||Contrast (B/A)|0.9811||||0.806|TWO_SIDED|95.0|0.8608|1.1182|||General linear model|||||1.1182|0.8608|0.806
71918847|NCT02176005|143359499|OTHER||Contrast (B/A)|0.8785||||0.139|TWO_SIDED|95.0|0.76|1.0155|||General linear model|||||1.0155|0.7600|0.139
71918848|NCT02176005|143359500|OTHER||Contrast (B/A)|1.1763||||0.104|TWO_SIDED|95.0|0.9982|1.3861|||General linear model|||||1.3861|0.9982|0.104
71685372|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.134||0.0013|TWO_SIDED|90.0|-0.67|-0.22|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.22|-0.67|0.0013
71685373|NCT00938587|142889276|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.135||0.3908|TWO_SIDED|90.0|-0.34|0.11|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.11|-0.34|0.3908
71685374|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.66|STANDARD_ERROR_OF_MEAN|7.093||0.6067|TWO_SIDED|90.0|-15.43|8.1|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.10|-15.43|0.6067
71685375|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.55|STANDARD_ERROR_OF_MEAN|7.101||0.1816|TWO_SIDED|90.0|-21.32|2.23|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.23|-21.32|0.1816
71685376|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.84|STANDARD_ERROR_OF_MEAN|7.029||0.6873|TWO_SIDED|90.0|-14.5|8.82|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.82|-14.50|0.6873
71685377|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.052||0.2188|TWO_SIDED|90.0|-20.42|2.98|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.98|-20.42|0.2188
71878100|NCT02234284|143275795|SUPERIORITY||difference in proportion|-18.9||||0.01|TWO_SIDED|95.0|-33.1|-4.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||-4.8|-33.1|.01
71878101|NCT02234284|143275796|SUPERIORITY||Mean Difference (Final Values)|14.6||||0.01|TWO_SIDED|95.0|3.3|25.9|||Mixed Models Analysis||Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.||25.9|3.3|.01
71878102|NCT01495858|143275805|SUPERIORITY_OR_OTHER|||||||0.3047|||||||ANCOVA|||||||0.3047
71685378|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.83|STANDARD_ERROR_OF_MEAN|7.024||0.9067|TWO_SIDED|90.0|-10.82|12.47|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||12.47|-10.82|0.9067
71685379|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.02|STANDARD_ERROR_OF_MEAN|7.254||0.5803|TWO_SIDED|90.0|-16.05|8.0|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.00|-16.05|0.5803
71685380|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.29|STANDARD_ERROR_OF_MEAN|7.156||0.249|TWO_SIDED|90.0|-20.16|3.57|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.57|-20.16|0.2490
71685381|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.62|STANDARD_ERROR_OF_MEAN|7.178||0.1081|TWO_SIDED|90.0|-23.52|0.28|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.28|-23.52|0.1081
71685382|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.89|STANDARD_ERROR_OF_MEAN|7.098||0.0271|TWO_SIDED|90.0|-27.66|-4.12|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-4.12|-27.66|0.0271
71685383|NCT00938587|142889277|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.6|STANDARD_ERROR_OF_MEAN|7.121||0.2881|TWO_SIDED|90.0|-19.41|4.21|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||4.21|-19.41|0.2881
71685384|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.52|STANDARD_ERROR_OF_MEAN|7.059||0.3579|TWO_SIDED|90.0|-18.23|5.19|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.19|-18.23|0.3579
71878103|NCT01495858|143275806|SUPERIORITY_OR_OTHER|||||||0.1677|||||||Log Rank|||||||0.1677
71685385|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.55|STANDARD_ERROR_OF_MEAN|7.046||0.2274|TWO_SIDED|90.0|-20.24|3.14|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.14|-20.24|0.2274
71685386|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.15|STANDARD_ERROR_OF_MEAN|6.973||0.1482|TWO_SIDED|90.0|-21.72|1.41|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.41|-21.72|0.1482
71685387|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-12.19|STANDARD_ERROR_OF_MEAN|6.962||0.0828|TWO_SIDED|90.0|-23.74|-0.64|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.64|-23.74|0.0828
71685388|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.64|STANDARD_ERROR_OF_MEAN|6.953||0.6021|TWO_SIDED|90.0|-15.17|7.9|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||7.90|-15.17|0.6021
71685389|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.28|STANDARD_ERROR_OF_MEAN|7.213||0.7528|TWO_SIDED|90.0|-14.24|9.68|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.68|-14.24|0.7528
71685390|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.17|STANDARD_ERROR_OF_MEAN|7.1||0.2523|TWO_SIDED|90.0|-19.94|3.6|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||3.60|-19.94|0.2523
71685391|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-11.63|STANDARD_ERROR_OF_MEAN|7.118||0.1049|TWO_SIDED|90.0|-23.43|0.17|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.17|-23.43|0.1049
71685392|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.53|STANDARD_ERROR_OF_MEAN|7.006||0.0138|TWO_SIDED|90.0|-29.14|-5.91|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-5.91|-29.14|0.0138
71685393|NCT00938587|142889278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.36|STANDARD_ERROR_OF_MEAN|7.052||0.1873|TWO_SIDED|90.0|-21.05|2.34|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.34|-21.05|0.1873
71685394|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.54|STANDARD_ERROR_OF_MEAN|5.339||0.509|TWO_SIDED|90.0|-12.4|5.32|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||5.32|-12.40|0.5090
71685395|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.89|STANDARD_ERROR_OF_MEAN|5.354||0.0998|TWO_SIDED|90.0|-17.78|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-17.78|0.0998
71685396|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|5.282||0.8866|TWO_SIDED|90.0|-9.52|8.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||8.01|-9.52|0.8866
71685397|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.11|STANDARD_ERROR_OF_MEAN|5.28||0.2499|TWO_SIDED|90.0|-14.88|2.66|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.66|-14.88|0.2499
71878104|NCT01495858|143275807|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
71878105|NCT01495858|143275808|SUPERIORITY_OR_OTHER|||||||0.2764|||||||ANCOVA|||||||0.2764
71878106|NCT01495858|143275809|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71878107|NCT01495858|143275810|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
71878108|NCT01495858|143275811|SUPERIORITY_OR_OTHER|||||||0.0145|||||||Cochran-Mantel-Haenszel|||||||0.0145
71878109|NCT01495858|143275812|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
71918849|NCT02176005|143359501|OTHER||Contrast (B/A)|0.9391||||0.519|TWO_SIDED|95.0|0.7969|1.1066|||General linear model|||||1.1066|0.7969|0.519
71918850|NCT02274766|143359506|SUPERIORITY||Least Squares Mean Difference|-14.4|STANDARD_ERROR_OF_MEAN|3.03|<|0.0001|TWO_SIDED|95.0|-20.4|-8.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable; the baseline value is a continuous covariate||32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.||-8.3|-20.4|<0.0001
71878110|NCT01495858|143275813|SUPERIORITY_OR_OTHER|||||||0.0387|||||||Cochran-Mantel-Haenszel|||||||0.0387
71878111|NCT01495858|143275814|SUPERIORITY_OR_OTHER|||||||0.0305|||||||Cochran-Mantel-Haenszel|||||||0.0305
71918851|NCT02274766|143359507|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|0.775||0.0168|TWO_SIDED|95.0|0.35|3.45||Change from Baseline in ON time without troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||3.45|0.35|0.0168
71685398|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.78|STANDARD_ERROR_OF_MEAN|5.283||0.5995|TWO_SIDED|90.0|-5.99|11.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||11.55|-5.99|0.5995
71685399|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.6|STANDARD_ERROR_OF_MEAN|5.429||0.9117|TWO_SIDED|90.0|-8.4|9.61|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||9.61|-8.40|0.9117
71685400|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.91|STANDARD_ERROR_OF_MEAN|5.381||0.0684|TWO_SIDED|90.0|-18.84|-0.98|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.98|-18.84|0.0684
71685401|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-6.49|STANDARD_ERROR_OF_MEAN|5.366||0.2292|TWO_SIDED|90.0|-15.39|2.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||2.42|-15.39|0.2292
71685402|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.0|STANDARD_ERROR_OF_MEAN|5.308||0.0018|TWO_SIDED|90.0|-25.81|-8.19|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-8.19|-25.81|0.0018
71685403|NCT00938587|142889279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.09|STANDARD_ERROR_OF_MEAN|5.337||0.1867|TWO_SIDED|90.0|-15.95|1.76|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.76|-15.95|0.1867
71685404|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|2.708||0.9624|TWO_SIDED|90.0|-4.64|4.38|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using analysis of covariance (ANCOVA) where treatment as fixed effect, baseline as the covariate.||4.38|-4.64|0.9624
71685405|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|2.65||0.9493|TWO_SIDED|90.0|-4.24|4.58|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.58|-4.24|0.9493
71685406|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.46|STANDARD_ERROR_OF_MEAN|2.738||0.21|TWO_SIDED|90.0|-1.1|8.02|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.02|-1.10|0.2100
71878112|NCT01495858|143275815|SUPERIORITY_OR_OTHER|||||||0.0176|||||||Cochran-Mantel-Haenszel|||||||0.0176
71878113|NCT01495858|143275816|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71685407|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|2.651||0.1602|TWO_SIDED|90.0|-0.66|8.18|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.18|-0.66|0.1602
71685408|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.59|STANDARD_ERROR_OF_MEAN|2.71||0.1892|TWO_SIDED|90.0|-0.92|8.1|||ANCOVA|||Physical functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.10|-0.92|0.1892
71685409|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.74|STANDARD_ERROR_OF_MEAN|2.781||0.7899|TWO_SIDED|90.0|-3.89|5.38|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.38|-3.89|0.7899
71918852|NCT02274766|143359507|SUPERIORITY||Least Squares Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.648||0.0853|TWO_SIDED|95.0|-2.42|0.16||Change from Baseline in ON time with troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures|||||0.16|-2.42|0.0853
71918853|NCT02274766|143359507|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.461||0.0199|TWO_SIDED|95.0|-2.02|-0.18||Change from Baseline in OFF time.|Linear Mixed Model w/ Repeated Measures|||||-0.18|-2.02|0.0199
71918854|NCT02530281|143359534|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71918855|NCT02530281|143359535|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
71918856|NCT02530281|143359536|OTHER||||||=|0.065|||||||ANCOVA|Ranked ANCOVA||||||=0.065
71685410|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.96|STANDARD_ERROR_OF_MEAN|2.719||0.149|TWO_SIDED|90.0|-0.56|8.49|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.49|-0.56|0.1490
71685411|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.36|STANDARD_ERROR_OF_MEAN|2.766||0.6238|TWO_SIDED|90.0|-5.97|3.24|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.24|-5.97|0.6238
71878114|NCT01495858|143275817|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Cochran-Mantel-Haenszel|||||||0.0036
71878115|NCT01495858|143275818|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71878116|NCT01495858|143275819|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
71878117|NCT01495858|143275820|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Cochran-Mantel-Haenszel|||||||>0.05
71878118|NCT01495858|143275821|SUPERIORITY_OR_OTHER|||||||0.4519|||||||ANCOVA|||||||0.4519
71878119|NCT01495858|143275822|SUPERIORITY_OR_OTHER|||||||0.3707|||||||ANCOVA|||||||0.3707
71878120|NCT01495858|143275823|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Log Rank|||||||>0.05
71918857|NCT02530281|143359537|OTHER||||||=|0.001|||||||ANCOVA|Ranked ANCOVA||||||=0.001
71685412|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.86|STANDARD_ERROR_OF_MEAN|2.699||0.4933|TWO_SIDED|90.0|-2.64|6.35|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.35|-2.64|0.4933
71685413|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.11|STANDARD_ERROR_OF_MEAN|2.739||0.4445|TWO_SIDED|90.0|-6.67|2.46|||ANCOVA|||Role physical at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.46|-6.67|0.4445
71685414|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.51|STANDARD_ERROR_OF_MEAN|2.897||0.2288|TWO_SIDED|90.0|-1.31|8.34|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.34|-1.31|0.2288
71685415|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|2.844||0.098|TWO_SIDED|90.0|0.03|9.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||9.50|0.03|0.0980
71685416|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|STANDARD_ERROR_OF_MEAN|2.941||0.0637|TWO_SIDED|90.0|0.64|10.43|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate||10.43|0.64|0.0637
71685417|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|2.831||0.019|TWO_SIDED|90.0|2.07|11.5|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.50|2.07|0.0190
71685418|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.02|STANDARD_ERROR_OF_MEAN|2.903||0.4886|TWO_SIDED|90.0|-2.81|6.86|||ANCOVA|||Bodily pain at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.86|-2.81|0.4886
71685419|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.879||0.9951|TWO_SIDED|90.0|-3.12|3.14|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.14|-3.12|0.9951
71878121|NCT01495858|143275825|SUPERIORITY_OR_OTHER|||||||0.3765|||||||Cochran-Mantel-Haenszel|||||||0.3765
71918858|NCT02530281|143359538|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71878122|NCT01576172|143275846|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71878123|NCT01576172|143275847|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t=-0.39 on 112.7 degrees of freedom (Satterthwaite)||||||0.70
71918859|NCT02530281|143359539|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71918860|NCT00535236|143359540|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||<0.001
71685420|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|1.818||0.4721|TWO_SIDED|90.0|-1.71|4.34|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.34|-1.71|0.4721
71685421|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|1.879||0.6835|TWO_SIDED|90.0|-3.9|2.36|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.36|-3.90|0.6835
71685422|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.53|STANDARD_ERROR_OF_MEAN|1.818||0.7701|TWO_SIDED|90.0|-2.49|3.56|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.56|-2.49|0.7701
71685423|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.831||0.671|TWO_SIDED|90.0|-3.83|2.27|||ANCOVA|||General health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||2.27|-3.83|0.6710
71685424|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.02|STANDARD_ERROR_OF_MEAN|2.827||0.2886|TWO_SIDED|90.0|-1.69|7.73|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.73|-1.69|0.2886
71685425|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.22|STANDARD_ERROR_OF_MEAN|2.784||0.134|TWO_SIDED|90.0|-0.42|8.86|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.86|-0.42|0.1340
71878124|NCT01576172|143275848|SUPERIORITY|||||||0.51|||||||Chi-squared|||||||0.51
71878125|NCT01576172|143275849|SUPERIORITY|||||||0.99|||||||Log Rank|||||||0.99
71878126|NCT01576172|143275850|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71878127|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative Improvement (%)|8.4|||<|0.001|TWO_SIDED|95.0|7.0|9.7|||a large sample test (z-test)|||Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).||9.7|7.0|<0.001
71878128|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative improvement (%)|8.6|||<|0.001|TWO_SIDED|95.0|7.7|9.6|||a large sample test (z-test)|||Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.||9.6|7.7|<0.001
71878129|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative improvement (%)|79.7|||<|0.001|TWO_SIDED|95.0|70.5|89.0|||a large sample test (z-test)|||Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.||89.0|70.5|<0.001
71918861|NCT00535236|143359540|OTHER|||||||0.003||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.003
71685426|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.24|STANDARD_ERROR_OF_MEAN|2.83||0.2563|TWO_SIDED|90.0|-1.48|7.95|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.95|-1.48|0.2563
71685427|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.43|STANDARD_ERROR_OF_MEAN|2.771||0.1138|TWO_SIDED|90.0|-0.18|9.05|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.05|-0.18|0.1138
71685428|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|2.793||0.9386|TWO_SIDED|90.0|-4.44|4.87|||ANCOVA|||Vitality at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.87|-4.44|0.9386
71685429|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.4|STANDARD_ERROR_OF_MEAN|2.701||0.8814|TWO_SIDED|90.0|-4.09|4.9|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.90|-4.09|0.8814
71685430|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.98|STANDARD_ERROR_OF_MEAN|2.64||0.1363|TWO_SIDED|90.0|-0.42|8.37|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.37|-0.42|0.1363
71878130|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative Improvement (%)|1.0||||0.546|TWO_SIDED|95.0|-2.2|4.2|||a large sample test (z-test)|||Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.||4.2|-2.2|0.546
71918862|NCT00535236|143359540|OTHER|||||||0.017||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.017
71918863|NCT00535236|143359541|OTHER||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjustied for prevaccination values||||||<0.001
71918864|NCT00535236|143359541|OTHER|||||||0.004||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.004
71685431|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.73|STANDARD_ERROR_OF_MEAN|2.682||0.7864|TWO_SIDED|90.0|-3.74|5.2|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.20|-3.74|0.7864
71685432|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|2.619||0.1048|TWO_SIDED|90.0|-0.06|8.66|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.66|-0.06|0.1048
71685433|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.33|STANDARD_ERROR_OF_MEAN|2.643||0.9024|TWO_SIDED|90.0|-4.08|4.73|||ANCOVA|||Social functioning at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.73|-4.08|0.9024
71685434|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.62|STANDARD_ERROR_OF_MEAN|3.819||0.4954|TWO_SIDED|90.0|-3.74|8.98|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.98|-3.74|0.4954
71685435|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.14|STANDARD_ERROR_OF_MEAN|3.735||0.1729|TWO_SIDED|90.0|-1.08|11.36|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||11.36|-1.08|0.1729
71878131|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative Improvement (%)|81.9|||<|0.001|TWO_SIDED|95.0|72.2|91.7|||a large sample test (z-test)|||Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).||91.7|72.2|<0.001
71918865|NCT00535236|143359541|OTHER|||||||0.026||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being \>1.0|Single longitudinal regression model|Adjusted for prevaccination values||||||0.026
71685436|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21|STANDARD_ERROR_OF_MEAN|3.82||0.565|TWO_SIDED|90.0|-4.15|8.57|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.57|-4.15|0.5650
71685437|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|STANDARD_ERROR_OF_MEAN|3.73||0.2087|TWO_SIDED|90.0|-1.48|10.94|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.94|-1.48|0.2087
71685438|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|3.771||0.9139|TWO_SIDED|90.0|-6.69|5.87|||ANCOVA|||Role emotional at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.87|-6.69|0.9139
71878132|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative Improvement (%)|62.1|||<|0.001|TWO_SIDED|95.0|59.1|65.1|||a large sample test (z-test)|||Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.||65.1|59.1|<0.001
71918866|NCT00535236|143359542|OTHER||Difference in Percentages|12.5|||||TWO_SIDED|95.0|-21.7|35.3|||||V212 minus placebo = Difference|||35.3|-21.7|
71685439|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.51|STANDARD_ERROR_OF_MEAN|3.371||0.6559|TWO_SIDED|90.0|-4.11|7.12|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.12|-4.11|0.6559
71685440|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.15|STANDARD_ERROR_OF_MEAN|3.315||0.7304|TWO_SIDED|90.0|-4.37|6.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.67|-4.37|0.7304
71685441|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.64|STANDARD_ERROR_OF_MEAN|3.369||0.1729|TWO_SIDED|90.0|-0.98|10.25|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||10.25|-0.98|0.1729
71685442|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|3.335||0.2038|TWO_SIDED|90.0|-1.28|9.83|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.83|-1.28|0.2038
71685443|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|3.328||0.3503|TWO_SIDED|90.0|-2.41|8.67|||ANCOVA|||Mental health at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.67|-2.41|0.3503
71685444|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.29|STANDARD_ERROR_OF_MEAN|2.01||0.8875|TWO_SIDED|90.0|-3.06|3.63|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||3.63|-3.06|0.8875
71685445|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97|STANDARD_ERROR_OF_MEAN|1.971||0.3203|TWO_SIDED|90.0|-1.31|5.25|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||5.25|-1.31|0.3203
71685446|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.046||0.5232|TWO_SIDED|90.0|-2.09|4.72|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.72|-2.09|0.5232
71685447|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.0|STANDARD_ERROR_OF_MEAN|1.971||0.1324|TWO_SIDED|90.0|-0.28|6.28|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.28|-0.28|0.1324
71685448|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.03|STANDARD_ERROR_OF_MEAN|2.024||0.6134|TWO_SIDED|90.0|-2.34|4.4|||ANCOVA|||Physical component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||4.40|-2.34|0.6134
71878133|NCT00303979|143275851|SUPERIORITY_OR_OTHER||Relative Improvement (%)|14.7|||<|0.001|TWO_SIDED|95.0|12.6|16.8|||a large sample test (z-test)|||Performance Measure #7: relative change in % of eligible patients with HF education.||16.8|12.6|<0.001
71685449|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.26|STANDARD_ERROR_OF_MEAN|3.387||0.5059|TWO_SIDED|90.0|-3.38|7.91|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||7.91|-3.38|0.5059
71685450|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.44|STANDARD_ERROR_OF_MEAN|3.329||0.3042|TWO_SIDED|90.0|-2.1|8.99|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.99|-2.10|0.3042
71685451|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.18|STANDARD_ERROR_OF_MEAN|3.39||0.3519|TWO_SIDED|90.0|-2.47|8.82|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||8.82|-2.47|0.3519
71685452|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.36|STANDARD_ERROR_OF_MEAN|3.342||0.1966|TWO_SIDED|90.0|-1.21|9.92|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||9.92|-1.21|0.1966
71685453|NCT00938587|142889280|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.91|STANDARD_ERROR_OF_MEAN|3.345||0.786|TWO_SIDED|90.0|-4.66|6.48|||ANCOVA|||Mental component at D14: Treatment difference and its corresponding 90% CI was based on LS mean difference using ANCOVA where treatment as fixed effect, baseline as the covariate.||6.48|-4.66|0.7860
71685454|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.286||0.109|TWO_SIDED|90.0|-0.93|0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.01|-0.93|0.1090
71878134|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.4||||0.004|TWO_SIDED|95.0|-1.1|39.8|||t-test, 2 sided|||Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.||39.8|-1.1|0.004
71878135|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|7.6|||<|0.001|TWO_SIDED|95.0|5.1|10.2|||t-test, 2 sided|||Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.||10.2|5.1|<0.001
71878136|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|30.0|||<|0.001|TWO_SIDED|95.0|24.6|35.5|||t-test, 2 sided|||Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.||35.5|24.6|<0.001
71878137|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|1.0||||0.513||95.0|-3.6|5.5|||t-test, 2 sided|||Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.||5.5|-3.6|0.513
71918867|NCT00535236|143359542|OTHER||Difference in Percentages|10.0|||||TWO_SIDED|95.0|-15.1|42.9|||||V212 minus placebo = Difference|||42.9|-15.1|
71685455|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.282||0.0014|TWO_SIDED|90.0|-1.38|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.38|0.0014
71685456|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.284||0.0506|TWO_SIDED|90.0|-1.03|-0.09|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.09|-1.03|0.0506
71685457|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.28||0.0004|TWO_SIDED|90.0|-1.48|-0.55|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.55|-1.48|0.0004
71685458|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.281||0.7272|TWO_SIDED|90.0|-0.56|0.37|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.56|0.7272
71685459|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.296||0.0604|TWO_SIDED|90.0|-1.05|-0.07|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.07|-1.05|0.0604
71685460|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.285||0.0003|TWO_SIDED|90.0|-1.53|-0.59|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.59|-1.53|0.0003
71685461|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.291||0.0377|TWO_SIDED|90.0|-1.09|-0.13|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.13|-1.09|0.0377
71685462|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.28||0.0001|TWO_SIDED|90.0|-1.57|-0.65|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.65|-1.57|0.0001
71878138|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|48.4|||<|0.001|TWO_SIDED|95.0|37.9|58.8|||t-test, 2 sided|||Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.||58.8|37.9|<0.001
71685463|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.284||0.8612|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8612
71685464|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.44|STANDARD_ERROR_OF_MEAN|0.292||0.133|TWO_SIDED|90.0|-0.04|0.93|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.93|-0.04|0.1330
71685465|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.285||0.8542|TWO_SIDED|90.0|-0.52|0.42|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.42|-0.52|0.8542
71685466|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34|STANDARD_ERROR_OF_MEAN|0.288||0.2339|TWO_SIDED|90.0|-0.13|0.82|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.82|-0.13|0.2339
71685467|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.5927|TWO_SIDED|90.0|-0.61|0.31|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.61|0.5927
71685468|NCT00938587|142889281|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.284||0.7304|TWO_SIDED|90.0|-0.57|0.37|||MMRM|||Day 42: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.37|-0.57|0.7304
71878139|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|70.9|||<|0.001|TWO_SIDED|95.0|61.0|80.8|||t-test, 2 sided|||Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.||80.8|61.0|<0.001
71878140|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|50.6|||<|0.001|TWO_SIDED|95.0|27.1|74.2|||t-test, 2 sided|||Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.||74.2|27.1|<0.001
71918868|NCT00535236|143359542|OTHER||Difference in Percentages|1.8|||||TWO_SIDED|95.0|-20.4|15.7|||||V212 minus placebo = Difference|||15.7|-20.4|
71918869|NCT00535236|143359542|OTHER||Difference in Percentages|14.4|||||TWO_SIDED|95.0|-6.5|27.6|||||V212 minus placebo = Difference|||27.6|-6.5|
71918870|NCT00535236|143359542|OTHER||Difference in Percentages|3.3|||||TWO_SIDED|95.0|-18.1|17.0|||||V212 minus placebo = Difference|||17.0|-18.1|
71918871|NCT00535236|143359543|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-31.7|16.5|||Asymptotic method||V212 minus placebo = Difference|||16.5|-31.7|>0.999
71685469|NCT00938587|142889282|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.29||0.0956|TWO_SIDED|90.0|-0.97|-0.01|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.01|-0.97|0.0956
71878141|NCT00303979|143275853|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|19.2|||<|0.001|TWO_SIDED|95.0|16.3|22.0|||t-test, 2 sided|||Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.||22.0|16.3|<0.001
71878142|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.3||||0.197|TWO_SIDED|95.0|-5.4|25.9|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||25.9|-5.4|0.197
71878143|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6||||0.061|TWO_SIDED|95.0|-0.5|21.7|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||21.7|-0.5|0.061
71878144|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.1||||0.622|TWO_SIDED|95.0|-5.7|3.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||3.4|-5.7|0.622
71878145|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.2||||0.05|TWO_SIDED|95.0|0.0|12.4|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||12.4|0.0|0.05
71878146|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|-1.8||||0.711|TWO_SIDED|95.0|-11.2|7.7|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||7.7|-11.2|0.711
71878147|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.4|||<|0.001|TWO_SIDED|95.0|6.9|22.0|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||22.0|6.9|<0.001
71878148|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|38.5|||<|0.001|TWO_SIDED|95.0|23.2|53.8|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.||53.8|23.2|<0.001
71878149|NCT00303979|143275854|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.6|||<|0.001|TWO_SIDED|95.0|4.2|9.0|||t-test, 2 sided|||Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.||9.0|4.2|<0.001
71878150|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.5||||0.19|TWO_SIDED|95.0|-5.3|26.3|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.||26.3|-5.3|0.190
71878151|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|14.3||||0.048|TWO_SIDED|95.0|0.1|28.4|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.||28.4|0.1|0.048
71878152|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|5.8||||0.24|TWO_SIDED|95.0|-3.9|15.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.||15.4|-3.9|0.240
71878153|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|6.7||||0.033|TWO_SIDED|95.0|0.5|13.0|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.||13.0|0.5|0.033
71878154|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|9.3||||0.085|TWO_SIDED|95.0|-1.3|19.8|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.||19.8|-1.3|0.085
71878155|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|17.6|||<|0.001|TWO_SIDED|95.0|9.3|25.8|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.||25.8|9.3|<0.001
71878156|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|59.5|||<|0.001|TWO_SIDED|95.0|33.9|85.2|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.||85.2|33.9|<0.001
71878157|NCT00303979|143275855|SUPERIORITY_OR_OTHER||Mean Relative Change (%)|10.6|||<|0.001|TWO_SIDED|95.0|7.6|13.6|||t-test, 2 sided|||Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.||13.6|7.6|<0.001
71878158|NCT01843972|143275876|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|97.88|STANDARD_DEVIATION|24.8|||TWO_SIDED|90.0|79.963|119.809|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||119.809|79.963|
71918872|NCT00535236|143359543|OTHER||Difference in Percentages|10.0||||0.302|TWO_SIDED|95.0|-18.8|23.2|||Asymptotic method||V212 minus placebo = Difference|||23.2|-18.8|0.302
71918873|NCT00535236|143359543|OTHER||Difference in Percentages|31.6||||0.009|TWO_SIDED|95.0|9.7|46.2|||Asymptotic method||V212 minus placebo = Difference|||46.2|9.7|0.009
71918874|NCT00535236|143359543|OTHER||Difference in Percentages|22.6||||0.041|TWO_SIDED|95.0|1.3|36.6|||Asymptotic method||V212 minus placebo = Difference|||36.6|1.3|0.041
71918875|NCT00535236|143359543|OTHER||Difference in Percentages|-11.7||||0.064|TWO_SIDED|95.0|-33.2|0.6|||Asymptotic method||V212 minus placebo = Difference|||0.6|-33.2|0.064
71918876|NCT00535236|143359544|OTHER||Difference in Percentages|-5.0||||0.556|TWO_SIDED|95.0|-36.3|9.5|||Asymptotic method||V212 minus placebo = Difference|||9.5|-36.3|0.556
71685470|NCT00938587|142889282|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.93|STANDARD_ERROR_OF_MEAN|0.286||0.0016|TWO_SIDED|90.0|-1.4|-0.45|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.45|-1.40|0.0016
71685471|NCT00938587|142889282|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.65|STANDARD_ERROR_OF_MEAN|0.287||0.0258|TWO_SIDED|90.0|-1.13|-0.17|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.17|-1.13|0.0258
71685472|NCT00938587|142889282|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.09|STANDARD_ERROR_OF_MEAN|0.283||0.0002|TWO_SIDED|90.0|-1.56|-0.62|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||-0.62|-1.56|0.0002
71685473|NCT00938587|142889282|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.284||0.5692||90.0|-0.63|0.31|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.31|-0.63|0.5692
71685474|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.146|TWO_SIDED|90.0|-8.65|35.98|||Barnard exact test|||Day 7||35.98|-8.65|0.1460
71685475|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|38.1||||0.0052|TWO_SIDED|90.0|12.25|59.46|||Barnard exact test|||Day 7||59.46|12.25|0.0052
71685476|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.3||||0.5094|TWO_SIDED|90.0|-22.0|24.66|||Barnard exact test|||Day 7||24.66|-22.00|0.5094
71685477|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|25.11||||0.0551|TWO_SIDED|90.0|-0.69|48.34|||Barnard exact test|||Day 7||48.34|-0.69|0.0551
71685478|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-12.99||||0.9999|TWO_SIDED|90.0|-34.09|8.78|||Barnard exact test|||Day 7||8.78|-34.09|0.9999
71685479|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|10.56||||0.3027|TWO_SIDED|90.0|-17.18|37.67|||Barnard-Exact test|||Day 14||37.67|-17.18|0.3027
71685480|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|21.67||||0.1074|TWO_SIDED|90.0|-6.24|46.16|||Barnard-Exact test|||Day 14||46.16|-6.24|0.1074
71685481|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|17.46||||0.234|TWO_SIDED|90.0|-10.08|43.7|||Barnard-Exact test|||Day 14||43.70|-10.08|0.2340
71685482|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|28.57||||0.0442|TWO_SIDED|90.0|0.91|53.07|||Barnard-Exact test|||Day 14||53.07|0.91|0.0442
71685483|NCT00938587|142889283|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|6.9||||0.3813|TWO_SIDED|90.0|-19.82|32.92|||Barnard-Exact test|||Day 14||32.92|-19.82|0.3813
71685484|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1017|TWO_SIDED|90.0|-3.9|27.09|||Barnard exact test|||Day 7||27.09|-3.90|0.1017
71685485|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0218|TWO_SIDED|90.0|4.49|38.44|||Barnard exact test|||Day 7||38.44|4.49|0.0218
71685486|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|9.52||||0.1082|TWO_SIDED|90.0|-3.71|27.06|||Barnard exact test|||Day 7||27.06|-3.71|0.1082
71685487|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|19.05||||0.0166|TWO_SIDED|90.0|4.81|38.44|||Barnard exact test|||Day 7||38.44|4.81|0.0166
71685488|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|2.22||||0.4776|TWO_SIDED|90.0|-21.61|25.87|||Barnard exact test|||Day 14||25.87|-21.61|0.4776
71685489|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|27.62||||0.0347|TWO_SIDED|90.0|2.53|50.78|||Barnard exact test|||Day 14||50.78|2.53|0.0347
71685490|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|7.94||||0.3343|TWO_SIDED|90.0|-13.71|31.59|||Barnard exact test|||Day 14||31.59|-13.71|0.3343
71685491|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|33.33||||0.0117|TWO_SIDED|90.0|8.35|55.0|||Barnard exact test|||Day 14||55.00|8.35|0.0117
71685492|NCT00938587|142889284|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|5.71||||0.372|TWO_SIDED|90.0|-15.86|27.04|||Barnard exact test|||Day 14||27.04|-15.86|0.3720
71685493|NCT00938587|142889285|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
71685494|NCT00938587|142889285|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.263|TWO_SIDED|90.0|-8.61|20.67|||Barnard exact test|||Day 7||20.67|-8.61|0.2630
71685495|NCT00938587|142889285|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
71685496|NCT00938587|142889285|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.76||||0.2539|TWO_SIDED|90.0|-7.51|20.67|||Barnard exact test|||Day 7||20.67|-7.51|0.2539
71685497|NCT00938587|142889285|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0477|TWO_SIDED|90.0|0.23|32.92|||Barnard exact test|||Day 14||32.92|0.23|0.0477
71685498|NCT00938587|142889285|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|14.29||||0.0442|TWO_SIDED|90.0|0.65|32.92|||Barnard exact test|||Day 14||32.92|0.65|0.0442
71918877|NCT00535236|143359544|OTHER||Difference in Percentages|2.5||||0.617|TWO_SIDED|95.0|-25.8|13.0|||Asymptotic method||V212 minus placebo = Difference|||13.0|-25.8|0.617
71918878|NCT00535236|143359544|OTHER||Difference in Percentages|3.5||||0.411|TWO_SIDED|95.0|-13.7|12.0|||Asymptotic method||V212 minus placebo = Difference|||12.0|-13.7|0.411
71918879|NCT00535236|143359544|OTHER||Difference in Percentages|4.9||||0.328|TWO_SIDED|95.0|-12.3|13.6|||Asymptotic method||V212 minus placebo = Difference|||13.6|-12.3|0.328
71918880|NCT00535236|143359544|OTHER||Difference in Percentages|0.0|||>|0.999|TWO_SIDED|95.0|-19.2|10.0|||Asymptotic method||V212 minus placebo = Difference|||10.0|-19.2|>0.999
71918881|NCT00535236|143359545|OTHER||Difference in Percentages|10.5||||0.552|TWO_SIDED|95.0|-21.3|41.8|||Asymptotic method||V212 minus placebo = Difference|||41.8|-21.3|0.552
71685499|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.33||0.5403|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5403
71685500|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.33||0.8374|TWO_SIDED|90.0|-0.61|0.48|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.48|-0.61|0.8374
71685501|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.26|STANDARD_ERROR_OF_MEAN|0.329||0.4305|TWO_SIDED|90.0|-0.28|0.8|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.28|0.4305
71685502|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.325||0.9733|TWO_SIDED|90.0|-0.55|0.53|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.53|-0.55|0.9733
71685503|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.325||0.8613|TWO_SIDED|90.0|-0.48|0.6|||MMRM|||Day 7: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.60|-0.48|0.8613
71685504|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.341||0.5245|TWO_SIDED|90.0|-0.35|0.78|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.78|-0.35|0.5245
71685505|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.334||0.8917|TWO_SIDED|90.0|-0.6|0.51|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.51|-0.60|0.8917
71685506|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.339||0.1695|TWO_SIDED|90.0|-0.09|1.03|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||1.03|-0.09|0.1695
71685507|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.329||0.5339|TWO_SIDED|90.0|-0.34|0.75|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.75|-0.34|0.5339
71685508|NCT00938587|142889288|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.25|STANDARD_ERROR_OF_MEAN|0.332||0.452|TWO_SIDED|90.0|-0.3|0.8|||MMRM|||Day 14: Treatment difference and its corresponding 90% CI was based on LS mean difference using MMRM where treatment, time, treatment-by-time interaction were fixed effects, participant as random effect, baseline as the covariate and CS as covariance structure.||0.80|-0.30|0.4520
71878159|NCT01843972|143275876|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|111.2|STANDARD_DEVIATION|24.7|||TWO_SIDED|90.0|88.596|139.576|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||139.576|88.596|
71685509|NCT00548249|142889301|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.0||||0.999|TWO_SIDED|95.0|0.3|3.32||p-value not adjusted for multiple comparisons|Log Rank|||Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model||3.32|0.30|0.999
71878160|NCT01843972|143275877|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|101.31|STANDARD_DEVIATION|28.2|||TWO_SIDED|90.0|80.593|127.351|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||127.351|80.593|
71878161|NCT01843972|143275877|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|92.69|STANDARD_DEVIATION|33.0|||TWO_SIDED|90.0|68.662|125.119|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||125.119|68.662|
71685510|NCT00548249|142889301|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.17||||0.807|TWO_SIDED|95.0|0.33|4.09|||Log Rank|||||4.09|0.33|0.807
71878162|NCT01843972|143275878|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0233|||||TWO_SIDED|95.0|0.8265|1.2201|||Regression, Linear|||||1.2201|0.8265|
71685511|NCT00548249|142889301|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|0.8||||0.748|TWO_SIDED|95.0|0.21|3.02|||Log Rank|||||3.02|0.21|0.748
71878163|NCT01843972|143275879|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|0.9686|||||TWO_SIDED|95.0|0.8107|1.1266|||Regression, Linear|||Dose proportionality of BI 691751 was explored using a power model (regression model applied to log-transformed data).||1.1266|0.8107|
71878164|NCT01843972|143275880|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|95.48|STANDARD_DEVIATION|30.8|||TWO_SIDED|90.0|74.414|122.511|||ANOVA||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.||122.511|74.414|
71878165|NCT01843972|143275880|SUPERIORITY_OR_OTHER||Geometric mean ratio (net)|109.8|STANDARD_DEVIATION|28.8|||TWO_SIDED|90.0|84.376|142.894|||ANOVA||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').||142.894|84.376|
71878166|NCT01843972|143275880|NON_INFERIORITY_OR_EQUIVALENCE|This was non-confirmatory testing.|Slope|1.0312|||||TWO_SIDED|95.0|0.833|1.179|||Regression, Linear|||||1.1790|0.833|
71918882|NCT00535236|143359545|OTHER||Difference in Percentages|6.7||||0.696|TWO_SIDED|95.0|-22.5|39.4|||Asymptotic method||V212 minus placebo = Difference|||39.4|-22.5|0.696
71878167|NCT01854645|143275905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
71878168|NCT01854645|143275905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71878169|NCT01854645|143275905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
71878170|NCT01854645|143275905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71878171|NCT01854645|143275905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 5 min post dose||||<0.0001
71878172|NCT01854645|143275905|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||At 15 min post dose||||<0.0001
71878173|NCT00545402|143275911|SUPERIORITY_OR_OTHER|||||||0.2611|||||||Log Rank|||||||0.2611
71878174|NCT00545402|143275913|SUPERIORITY_OR_OTHER|||||||0.7091|||||||Log Rank|||||||0.7091
71878175|NCT01721876|143275916|SUPERIORITY|The 2-sided test of the hypothesis was performed at a 0.05 level of significance. An odds ratio (OR) = 1 would indicate that the odds of achieving CR+CRi with Volasertib + Low-dose Cytarabine is equal to the odds of achieving CR+CRi with Placebo + Low-dose Cytarabine , whereas an OR ≠ 1 would indicate the opposite. H0, CR+CRi: OR = 1 vs. Ha, CR+CRi: OR ≠ 1.|Odds Ratio (OR)|1.8751||||0.0024|TWO_SIDED|95.0|1.2432|2.8281|||Cochran-Mantel-Haenszel||Common odds ratio is calculated by Mantel-Haenszel estimate adjusting for the two stratification factors (baseline Eastern Cooperative Oncology Group (ECOG) and type of AML). If odds ratio is above 1 then it favours Volasertib+Low-dose Cytarabine.|This analysis was exploratory and descriptive.||2.8281|1.2432|0.0024
71878176|NCT01721876|143275917|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.97||||0.7571|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.7571
71878177|NCT01721876|143275918|SUPERIORITY|The hazard ratio (HR) between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine was tested against 1. The null hypothesis, H0,OS, was that the hazards are equal between Volasertib + Low-dose Cytarabine and Placebo + Low-dose Cytarabine, whereas the alternative hypothesis, Ha,OS, was that the hazards are not equal between the 2 treatment arms. H0, OS: HR = 1 vs. Ha, OS: HR ≠ 1.|Hazard Ratio (HR)|0.96||||0.6718|TWO_SIDED|95.0|0.8|1.2||P-value is calculated from log-rank test stratified by baseline ECOG (0-1 vs. 2) and type of AML (denovo vs. secondary).|Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|This analysis was exploratory and descriptive.||1.2|0.8|0.6718
71878178|NCT01721876|143275919|OTHER||Hazard Ratio (HR)|1.37|||||TWO_SIDED|95.0|0.7|2.7|||Regression, Cox||Hazard ratio is calculated from Cox proportional hazard model stratified by baseline ECOG and type of AML. If hazard ratio is below 1 then it favours volasertib.|||2.7|0.7|
71878179|NCT03086265|143275920|OTHER|||||||0.7934|||||||t-test, 2 sided|||||||0.7934
71878180|NCT03086265|143275929|OTHER|||||||0.6876|||||||t-test, 2 sided|||||||0.6876
71685512|NCT00548249|142889301|SUPERIORITY_OR_OTHER_LEGACY||Cox Proportional Hazard|1.77||||0.299|TWO_SIDED|95.0|0.6|5.19|||Log Rank|||||5.19|0.60|0.299
71878181|NCT03086265|143275930|OTHER|||||||0.7549|||||||t-test, 2 sided|||||||0.7549
71878182|NCT03086265|143275931|OTHER|||||||0.6479|||||||t-test, 2 sided|||||||0.6479
71878183|NCT03086265|143275932|OTHER|||||||0.8322|||||||t-test, 2 sided|||||||0.8322
71918883|NCT00535236|143359545|OTHER||Difference in Percentages|7.5||||0.221|TWO_SIDED|95.0|-9.8|18.0|||Asymptotic method||V212 minus placebo = Difference|||18.0|-9.8|0.221
71918884|NCT00535236|143359545|OTHER||Difference in Percentages|6.8||||0.402|TWO_SIDED|95.0|-13.7|19.1|||Asymptotic method||V212 minus placebo = Difference|||19.1|-13.7|0.402
71918885|NCT00535236|143359545|OTHER||Difference in Percentages|3.8||||0.679|TWO_SIDED|95.0|-18.5|18.2|||Asymptotic method||V212 minus placebo = Difference|||18.2|-18.5|0.679
71685513|NCT00548249|142889302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.234||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect.||||0.234
71685514|NCT00548249|142889302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.049||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.049
71878184|NCT03086265|143275934|OTHER|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
71878185|NCT03086265|143275935|OTHER|||||||0.3346|||||||t-test, 2 sided|||||||0.3346
71878186|NCT03086265|143275936|OTHER|||||||0.5513|||||||t-test, 2 sided|||||||0.5513
71878187|NCT03086265|143275937|OTHER|||||||0.1927|||||||t-test, 2 sided|||||||0.1927
71878188|NCT03086265|143275938|OTHER|||||||0.6483|||||||t-test, 2 sided|||||||0.6483
71878189|NCT03086265|143275939|OTHER|||||||0.5625|||||||t-test, 2 sided|||||||0.5625
71878190|NCT03086265|143275940|OTHER|||||||0.2827|||||||t-test, 2 sided|||||||0.2827
71878191|NCT03086265|143275941|OTHER|||||||0.8426|||||||t-test, 2 sided|||||||0.8426
71878192|NCT03086265|143275942|OTHER|||||||0.9856|||||||t-test, 2 sided|||||||0.9856
71878193|NCT03086265|143275943|OTHER|||||||0.8112|||||||t-test, 2 sided|||||||0.8112
71878194|NCT03086265|143275944|OTHER|||||||0.6587|||||||t-test, 2 sided|||||||0.6587
71878195|NCT03086265|143275945|OTHER|||||||0.4143|||||||t-test, 2 sided|||||||0.4143
71878196|NCT03086265|143275946|OTHER|||||||0.4324|||||||t-test, 2 sided|||||||0.4324
71878197|NCT03086265|143275947|OTHER|||||||0.7221|||||||t-test, 2 sided|||Comparison of preoperative scores.||||0.7221
71878198|NCT03086265|143275947|OTHER|||||||0.0336|||||||t-test, 2 sided|||Comparison of postoperative scores.||||0.0336
71878199|NCT01721057|143275948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||Regression, Logistic|||||||0.001
71878200|NCT01202279|143275969|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||95.0|||||Fisher Exact|||||||0.025
71878201|NCT01202279|143275970|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0|||||ANCOVA|||||||0.022
71878202|NCT02064920|143276000|SUPERIORITY_OR_OTHER||Change in SD from Week 4 to Week 16|0.005|||||TWO_SIDED|95.0|-0.031|0.039|||||SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.|Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined||0.039|-0.031|
71878203|NCT02109562|143276008|SUPERIORITY||Mean Difference (Final Values)|-6.148|STANDARD_ERROR_OF_MEAN|1.7261||0.0004|TWO_SIDED|95.0|-9.982|-2.314||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-2.314|-9.982|0.0004
71878204|NCT02109562|143276008|SUPERIORITY||Mean Difference (Final Values)|-7.237|STANDARD_ERROR_OF_MEAN|1.7141|<|0.0001|TWO_SIDED|95.0|-11.045|-3.429||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-3.429|-11.045|<0.0001
71878205|NCT02109562|143276009|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0934||0.0002|TWO_SIDED|95.0|-0.557|-0.143||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.143|-0.557|0.0002
71878206|NCT02109562|143276009|SUPERIORITY||Mean Difference (Final Values)|-0.396|STANDARD_ERROR_OF_MEAN|0.0928|<|0.0001|TWO_SIDED|95.0|-0.602|-0.19||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at \<0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.||-0.190|-0.602|<0.0001
71878207|NCT00688155|143276011|EQUIVALENCE|Two-sided test of mean differences from baseline.|Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.25||0.66|TWO_SIDED|||||Physical activity training versus no physical activity training;|ANOVA|||Marginal comparisons of physical activity training vs no physical activity training||||0.66
71878208|NCT00688155|143276011|EQUIVALENCE|Two-sided tests of mean differences from baseline.|Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.26||0.55|TWO_SIDED|||||P-value for physical activity training is 0.55|ANOVA|||Marginal comparisons of physical activity training versus no physical activity training||||0.55
71685515|NCT00548249|142889302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.375||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.375
71685516|NCT00548249|142889302|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625||95.0||||Threshold for statistical significance p \< 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect||||0.625
71685517|NCT04006509|142889374|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||||||0.985
71685518|NCT04006509|142889375|SUPERIORITY|||||||0.539|||||||Marginal Two-Part Model|||||||0.539
71685519|NCT04006509|142889376|SUPERIORITY|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||||||0.959
71685520|NCT04006509|142889377|SUPERIORITY|||||||0.743|||||||Marginal Two-Part Model|||||||0.743
71685521|NCT04006509|142889378|SUPERIORITY|||||||0.886|||||||Marginalized Two-Part Model|||||||0.886
71685522|NCT04006509|142889379|SUPERIORITY|||||||0.107|||||||Marginalized Two-Part Model|||||||0.107
71685523|NCT04006509|142889380|SUPERIORITY|||||||0.687|||||||Marginalized Two-Part Model|||||||0.687
71685524|NCT04006509|142889381|SUPERIORITY|||||||0.871|||||||Marginalized Two-Part Model|||||||0.871
71685525|NCT04006509|142889382|SUPERIORITY|||||||0.376|||||||Marginalized Two-Part Model|||||||0.376
71685526|NCT04006509|142889383|SUPERIORITY|||||||0.77|||||||Marginalized Two-Part Model|||||||0.770
71685527|NCT04006509|142889384|SUPERIORITY|||||||0.237|||||||Marginalized Two-Part Model|||||||0.237
71685528|NCT02759835|142889393|OTHER|||||||0.56|||||||Kaplan-Meier|||||||0.56
71685529|NCT02759835|142889395|OTHER|||||||0.4|||||||Kaplan-Meier|||||||0.40
71685530|NCT00002525|142889407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178||||||one-sided log-rank test p value|Log Rank|||||||0.178
71685531|NCT00002525|142889408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.847||||||two-sided log rank test|Log Rank|||||||0.847
71685532|NCT03230838|142889411|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|-1.6|||||TWO_SIDED|95.0|-19.7|17.9|||||Ceftolozane/Tazobactam (C/T) minus Meropenem (Mero)|Difference in Percentage (C/T minus Mero)||17.9|-19.7|
71685533|NCT03230838|142889412|OTHER|The Miettinen \& Nurminen method was used.|Percentage Difference|1.0|||||TWO_SIDED|95.0|-9.5|5.5|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||5.5|-9.5|
71685534|NCT03230838|142889413|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-7.3|||||TWO_SIDED|95.0|-17.99|10.05|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||10.05|-17.99|
71685535|NCT03230838|142889414|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-5.6|||||TWO_SIDED|95.0|-14.09|8.88|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||8.88|-14.09|
71685536|NCT03230838|142889415|OTHER|The Miettinen \& Nurminen method stratified by age group with Cochran- Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.0|||||TWO_SIDED|95.0|-17.13|17.4|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||17.40|-17.13|
71685537|NCT03230838|142889416|OTHER|The Miettinen \& Nurminen method stratified by age group with CMH weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.|Percentage Difference|-3.4|||||TWO_SIDED|95.0|-12.67|13.41|||||C/T minus Mero|Difference in Percentage (C/T minus Mero)||13.41|-12.67|
71685538|NCT01505179|142889417|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||||||0.47
71685539|NCT01505179|142889418|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71685540|NCT01505179|142889419|SUPERIORITY|||||||0.74|||||||t-test, 2 sided|||||||0.74
71685541|NCT01505179|142889420|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||||||0.49
71685542|NCT02697734|142889444|SUPERIORITY||Odds Ratio (OR)|43.4|||<|0.0001|TWO_SIDED|95.0|7.06|343.19|||Cochran-Mantel-Haenszel|||||343.19|7.06|<.0001
71685543|NCT02651688|142889481|SUPERIORITY|||||||0.7103|||||||Wilcoxon rank-sum test|||||||0.7103
71685544|NCT02651688|142889481|SUPERIORITY|||||||0.4529|||||||Wilcoxon rank-sum test|||||||0.4529
71685545|NCT02651688|142889482|SUPERIORITY|||||||0.9302|||||||Wilcoxon rank-sum test|||||||0.9302
71685546|NCT02651688|142889482|SUPERIORITY|||||||0.7509|||||||Wilcoxon rank-sum test|||||||0.7509
71685547|NCT02651688|142889483|SUPERIORITY|||||||0.5095|||||||Wilcoxon rank-sum test|||||||0.5095
71685548|NCT02651688|142889483|SUPERIORITY|||||||0.623|||||||Wilcoxon rank-sum test|||||||0.6230
71685549|NCT02651688|142889484|SUPERIORITY|||||||0.296|||||||Wilcoxon rank-sum test|||||||0.2960
71685550|NCT02651688|142889484|SUPERIORITY|||||||0.2723|||||||Wilcoxon rank-sum test|||||||0.2723
71685551|NCT02651688|142889485|SUPERIORITY|||||||0.0034|||||||Wilcoxon rank-sum test|||||||0.0034
71685552|NCT02651688|142889485|SUPERIORITY|||||||0.0027|||||||Wilcoxon rank-sum test|||||||0.0027
71685553|NCT02651688|142889486|SUPERIORITY|||||||0.0146|||||||Wilcoxon rank-sum test|||||||0.0146
71685554|NCT02651688|142889486|SUPERIORITY|||||||0.0018|||||||Wilcoxon rank-sum test|||||||0.0018
71685555|NCT02651688|142889487|SUPERIORITY|||||||0.1524|||||||Wilcoxon rank-sum test|||||||0.1524
71685556|NCT02651688|142889487|SUPERIORITY|||||||0.0227|||||||Wilcoxon rank-sum test|||||||0.0227
71685557|NCT02651688|142889488|SUPERIORITY|||||||0.5873|||||||Wilcoxon rank-sum test|||||||0.5873
71685558|NCT02651688|142889488|SUPERIORITY|||||||0.9509|||||||Wilcoxon rank-sum test|||||||0.9509
71685559|NCT02651688|142889489|SUPERIORITY|||||||0.4341|||||||Wilcoxon rank-sum test|||||||0.4341
71685560|NCT02651688|142889489|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.0000
71685561|NCT02651688|142889490|SUPERIORITY|||||||0.022|||||||Wilcoxon rank-sum test|||||||0.0220
71685562|NCT02651688|142889490|SUPERIORITY|||||||0.3677|||||||Wilcoxon rank-sum test|||||||0.3677
71685563|NCT02651688|142889491|SUPERIORITY|||||||0.9074|||||||Wilcoxon rank-sum test|||||||0.9074
71685564|NCT02651688|142889491|SUPERIORITY|||||||0.4517|||||||Wilcoxon rank-sum test|||||||0.4517
71685565|NCT02651688|142889492|SUPERIORITY|||||||0.2962|||||||Wilcoxon rank-sum test|||||||0.2962
71685566|NCT02651688|142889492|SUPERIORITY|||||||0.3261|||||||Wilcoxon rank-sum test|||||||0.3261
71685567|NCT02651688|142889493|SUPERIORITY|||||||0.045|||||||Wilcoxon rank-sum test|||||||0.0450
71685568|NCT02651688|142889493|SUPERIORITY|||||||0.2235|||||||Wilcoxon rank-sum test|||||||0.2235
71685569|NCT02651688|142889494|SUPERIORITY|||||||0.826|||||||Wilcoxon rank-sum test|||||||0.8260
71685570|NCT02651688|142889494|SUPERIORITY|||||||0.4183|||||||Wilcoxon rank-sum test|||||||0.4183
71685571|NCT02651688|142889495|SUPERIORITY|||||||0.1144|||||||Wilcoxon rank-sum test|||||||0.1144
71685572|NCT02651688|142889495|SUPERIORITY|||||||0.3263|||||||Wilcoxon rank-sum test|||||||0.3263
71685573|NCT02651688|142889496|SUPERIORITY|||||||0.1546|||||||Wilcoxon rank-sum test|||||||0.1546
71685574|NCT02651688|142889496|SUPERIORITY|||||||0.5732|||||||Wilcoxon rank-sum test|||||||0.5732
71685575|NCT02651688|142889497|SUPERIORITY|||||||0.5581|||||||Wilcoxon rank-sum test|||||||0.5581
71685576|NCT02651688|142889497|SUPERIORITY|||||||0.5833|||||||Wilcoxon rank-sum test|||||||0.5833
71685577|NCT02651688|142889498|SUPERIORITY|||||||0.0168|||||||Wilcoxon rank-sum test|||||||0.0168
71685578|NCT02651688|142889498|SUPERIORITY|||||||0.0364|||||||Wilcoxon rank-sum test|||||||0.0364
71878209|NCT00688155|143276011|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.25||0.95|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.95
71685579|NCT02651688|142889499|SUPERIORITY|||||||0.0992|||||||Wilcoxon rank-sum test|||||||0.0992
71685580|NCT02651688|142889499|SUPERIORITY|||||||0.1333|||||||Wilcoxon rank-sum|||||||0.1333
71685581|NCT02651688|142889500|SUPERIORITY|||||||0.0139|||||||Wilcoxon rank-sum test|||||||0.0139
71685582|NCT02651688|142889500|SUPERIORITY|||||||0.0225|||||||Wilcoxon rank-sum test|||||||0.0225
71685583|NCT00073008|142889521|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|34.5||||||95.0|13.7|55.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||55.4|13.7|
71878210|NCT00688155|143276011|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.26||0.48|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.48
71878211|NCT00688155|143276013|EQUIVALENCE|Two-sided tests of marginal means|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.29||0.23|TWO_SIDED||||||ANOVA|||Marginal comparisons of physical activity training versus no physical activity training.||||0.23
71878212|NCT00688155|143276013|EQUIVALENCE|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.29||0.42|TWO_SIDED||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training||||0.42
71878213|NCT02229539|143276056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Wilcoxon rank-sum|||||||0.02
71878214|NCT02229539|143276056|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Wilcoxon rank-sum|||||||0.004
71878215|NCT00257166|143276078|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-5.22|STANDARD_ERROR_OF_MEAN|1.48||0.0005|TWO_SIDED|95.0|-8.12|-2.31|||ANCOVA|||Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-2.31|-8.12|0.0005
71685584|NCT00073008|142889521|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|19.7||||||95.0|2.9|36.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||36.4|2.9|
71685585|NCT00073008|142889522|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|27.1||||||95.0|11.9|42.3|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||42.3|11.9|
71685586|NCT00073008|142889522|SUPERIORITY_OR_OTHER||Kaplan-Meier estimate|18.3||||||95.0|3.9|32.6|||||Percentage of surviving participants who were progression free 4 months after the date of randomization|||32.6|3.9|
71685587|NCT00808470|142889535|SUPERIORITY_OR_OTHER|||||||0.58|||||||t-test, 2 sided|||15 minutes after exposure||||0.58
71685588|NCT00808470|142889535|SUPERIORITY_OR_OTHER|||||||0.39|||||||t-test, 2 sided|||1 hour and 15 minutes after exposure||||0.39
71685589|NCT00808470|142889535|SUPERIORITY_OR_OTHER|||||||0.51|||||||t-test, 2 sided|||2 Hours 15 minutes after exposure||||.51
71685590|NCT00808470|142889535|SUPERIORITY_OR_OTHER|||||||0.36|||||||t-test, 2 sided|||3 hours, 15 minutes after exposure||||.36
71685591|NCT00808470|142889535|SUPERIORITY_OR_OTHER|||||||0.86|||||||t-test, 2 sided|||1 day after exposure||||.86
71685592|NCT00808470|142889535|SUPERIORITY_OR_OTHER|||||||0.24|||||||t-test, 2 sided|||1 week after exposure||||.24
71685593|NCT02494401|142889637|SUPERIORITY|||||||0.87||||||p value of baseline comparison.|Wilcoxon (Mann-Whitney)|||||||0.87
71685594|NCT02494401|142889637|SUPERIORITY|||||||0.32||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.32
71685595|NCT02494401|142889637|SUPERIORITY|||||||0.3||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.3
71685596|NCT02494401|142889638|SUPERIORITY|||||||0.08||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.08
71685597|NCT02494401|142889638|SUPERIORITY|||||||0.05||||||p value 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.05
71685598|NCT02494401|142889638|SUPERIORITY|||||||0.008||||||p value 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.008
71685599|NCT02494401|142889639|SUPERIORITY|||||||0.68||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.68
71685600|NCT02494401|142889639|SUPERIORITY|||||||0.83||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.83
71685601|NCT02494401|142889639|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.23
71685602|NCT02494401|142889640|SUPERIORITY|||||||0.96||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.96
71878216|NCT00257166|143276079|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.2545|STANDARD_ERROR_OF_MEAN|0.9422||0.0006|TWO_SIDED|95.0|-5.1045|-1.4046|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4046|-5.1045|0.0006
71685603|NCT02494401|142889640|SUPERIORITY|||||||0.69||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.69
71685604|NCT02494401|142889640|SUPERIORITY|||||||0.6||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.6
71685605|NCT02494401|142889641|SUPERIORITY|||||||0.89||||||p value baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.89
71878217|NCT00257166|143276079|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5857|STANDARD_ERROR_OF_MEAN|1.4184||0.0117|TWO_SIDED|95.0|-6.3705|-0.8009|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.8009|-6.3705|0.0117
71878218|NCT00257166|143276079|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.8665|STANDARD_ERROR_OF_MEAN|1.7154||0.0047|TWO_SIDED|95.0|-8.2345|-1.4985|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-1.4985|-8.2345|0.0047
71878219|NCT00257166|143276080|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3754|STANDARD_ERROR_OF_MEAN|0.0989||0.0002|TWO_SIDED|95.0|-0.5696|-0.1812|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.1812|-0.5696|0.0002
71918886|NCT00290355|143359602|OTHER||Hazard Ratio (HR)|0.74||||0.256|TWO_SIDED|95.0|0.44|1.24||Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = \[HR=1\]).|Regression, Cox|The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value \< 10%||Hazard ratio of GSK 249553 study product.||1.24|0.44|0.256
71918887|NCT03502941|143359632|SUPERIORITY||||||<|0.05||||||P value was calculated.|t-test, 2 sided|||||||<0.05
71918888|NCT03502941|143359633|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71918889|NCT01072500|143359634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.03|TWO_SIDED|95.0|0.69|0.98|||Regression, Cox|To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.||||0.98|0.69|0.03
71918890|NCT01072500|143359635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.006|TWO_SIDED|95.0|0.57|0.91|||Regression, Cox|||||0.91|0.57|0.006
71918891|NCT03798366|143359636|SUPERIORITY||Least square (LS) mean difference|-0.5|STANDARD_ERROR_OF_MEAN|1.29||0.6757|TWO_SIDED|95.0|-3.1|2.0|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||2.0|-3.1|0.6757
71918892|NCT03798366|143359637|SUPERIORITY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|1.31||0.6079|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||1.9|-3.3|0.6079
71918893|NCT03798366|143359638|SUPERIORITY||LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.35||0.1298|TWO_SIDED|95.0|-4.8|0.6|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||0.6|-4.8|0.1298
71685606|NCT02494401|142889641|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71685607|NCT02494401|142889641|SUPERIORITY|||||||0.56||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.56
71685608|NCT02494401|142889642|SUPERIORITY|||||||0.69||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.69
71685609|NCT02494401|142889642|SUPERIORITY|||||||0.29||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.29
71918894|NCT03798366|143359639|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.36||0.0411|TWO_SIDED|95.0|-5.6|-0.1|||Mixed Models Analysis||A negative difference indicates a greater improvement in the GLPG1690 treatment group.|Results were estimated using a mixed-effect model repeated measure using treatment and visit as fixed effects, baseline mRSS score and country as covariates, treatment-visit as interaction terms, and participant as a random effect. The variance-covariance matrix used in the model was compound symmetric.||-0.1|-5.6|0.0411
71685610|NCT02494401|142889642|SUPERIORITY|||||||0.07||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.07
71685611|NCT02494401|142889643|SUPERIORITY|||||||0.28||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.28
71685612|NCT02494401|142889643|SUPERIORITY|||||||0.16||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.16
71685613|NCT02494401|142889643|SUPERIORITY|||||||0.23||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.23
71685614|NCT02494401|142889644|SUPERIORITY|||||||0.93||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.93
71685615|NCT02494401|142889644|SUPERIORITY|||||||0.54||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.54
71685616|NCT02494401|142889644|SUPERIORITY|||||||0.33||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.33
71685617|NCT02494401|142889645|SUPERIORITY|||||||0.59||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.59
71685618|NCT02494401|142889645|SUPERIORITY|||||||0.25||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.25
71685619|NCT02494401|142889645|SUPERIORITY|||||||0.12||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.12
71878220|NCT00257166|143276080|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.5596|STANDARD_ERROR_OF_MEAN|0.1355|<|0.0001|TWO_SIDED|95.0|-0.8256|-0.2936|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.2936|-0.8256|<0.0001
71878221|NCT00257166|143276080|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6798|STANDARD_ERROR_OF_MEAN|0.1643|<|0.0001|TWO_SIDED|95.0|-1.0024|-0.3572|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3572|-1.0024|<0.0001
71878222|NCT00257166|143276080|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.6884|STANDARD_ERROR_OF_MEAN|0.1761||0.0001|TWO_SIDED|95.0|-1.0342|-0.3426|||ANCOVA|||Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.||-0.3426|-1.0342|0.0001
71878223|NCT00257166|143276081|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21||0.0004|TWO_SIDED|95.0|-1.18|-0.34|||ANCOVA|||Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.||-0.34|-1.18|0.0004
71878224|NCT04050670|143276084|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the thigh versus abdomen injection sites were from 0.80 to 1.25|Ratio of geometric least squares mean|0.953|||||TWO_SIDED|90.0|0.935|0.97|||Linear mixed effects model|||||0.970|0.935|
71878225|NCT04050670|143276084|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of AUC(0-∞) for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.99|||||TWO_SIDED|90.0|0.972|1.01|||Linear mixed effects model|||||1.01|0.972|
71878226|NCT04050670|143276085|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for thigh versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.862|||||TWO_SIDED|90.0|0.818|0.909|||Linear mixed effects model|||||0.909|0.818|
71878227|NCT04050670|143276085|NON_INFERIORITY|A priori estimates for the 90% CI geometric least square means ratios of Cmax for the upper arm versus abdomen injection sites were from 0.80 to 1.25.|Ratio of geometric least squares mean|0.921|||||TWO_SIDED|95.0|0.874|0.971|||Linear mixed effects model|||||0.971|0.874|
71878228|NCT01488279|143276167|SUPERIORITY||Mean Difference (Net)|-10.8|STANDARD_ERROR_OF_MEAN|480.8||0.983|TWO_SIDED|95.0|-1147.6|1126.0|||ANOVA|||2X2 crossover design with baseline values. To compare the means between Sitagliptin and Placebo, a sequential three step testing process used. The results of the third step, the direct treatment comparisons are presented.||1126.0|-1147.6|.983
71918895|NCT02120469|143359667|OTHER||||||||||||||||||Dose level B1 (eribulin 1.1 mg/m2 days 1 and 8 every 3 weeks with everolimus 5 mg daily) was defined as the highest dose with acceptable toxicity (RP2D).|||
71918896|NCT01369069|143359700|SUPERIORITY||Risk Ratio (RR)|0.97||||0.55|TWO_SIDED|95.0|0.87|1.08||The a priori threshold for statistical significance was 0.05.|Regression, Logistic||Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.|It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.||1.08|0.87|0.55
71918897|NCT01369069|143359701|SUPERIORITY||Risk Difference (RD)|2.58|||<|0.001|TWO_SIDED|95.0|1.29|3.87|||Fisher Exact||The data of the estimation parameter and the confidence intervals were presented as percentages.|||3.87|1.29|<0.001
71918898|NCT01369069|143359702|SUPERIORITY||Risk Difference (RD)|-1.07||||0.77|TWO_SIDED|95.0|-8.33|6.2|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.20|-8.33|0.77
71878229|NCT01488279|143276170|SUPERIORITY||Mean Difference (Net)|-0.008|STANDARD_ERROR_OF_MEAN|1.935||0.997|TWO_SIDED|95.0|-4.585|4.568|||ANOVA|||||4.568|-4.585|.997
71878230|NCT01488279|143276171|SUPERIORITY||Mean Difference (Net)|-38.9|STANDARD_ERROR_OF_MEAN|49.9||0.46|TWO_SIDED|95.0|-156.9|79.0|||ANOVA|||||79.0|-156.9|.460
71878231|NCT02247960|143276227|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.00
71878232|NCT01390272|143276231|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-2.1||||0.26|TWO_SIDED|95.0|-5.9|1.6|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||1.6|-5.9|0.26
71685620|NCT02494401|142889646|SUPERIORITY|||||||0.51||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.51
71878233|NCT01390272|143276232|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.3||||0.5|TWO_SIDED|95.0|-4.9|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-4.9|0.50
71878234|NCT01390272|143276233|NON_INFERIORITY_OR_EQUIVALENCE||Mean Difference (Net)|-1.6||||0.43|TWO_SIDED|95.0|-5.6|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.||||2.4|-5.6|0.43
71918899|NCT01369069|143359703|SUPERIORITY||Risk Difference (RD)|0.48||||0.88|TWO_SIDED|95.0|-5.79|6.75|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.|||6.75|-5.79|0.88
71918900|NCT01369069|143359704|SUPERIORITY||Median Difference (Final Values)|0.06||||0.74|TWO_SIDED|95.0|-0.13|0.25|||Wilcoxon (Mann-Whitney)|||||0.25|-0.13|0.74
71918901|NCT01369069|143359705|SUPERIORITY||Risk Ratio (RR)|0.82||||0.24|TWO_SIDED|95.0|0.58|1.15|||Chi-squared|||||1.15|0.58|0.24
71918902|NCT01846208|143359713|SUPERIORITY||Risk Difference (RD)|32.4||||0.009|TWO_SIDED|95.0|8.9|55.8|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized||55.8|8.9|0.009
71918903|NCT01846208|143359713|SUPERIORITY||Risk Difference (RD)|25.5||||0.031|TWO_SIDED|95.0|2.0|49.1|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||49.1|2.0|0.031
71918904|NCT01846208|143359714|SUPERIORITY||Risk Difference (RD)|64.7|||<|0.0001|TWO_SIDED|95.0|43.9|85.6|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized||85.6|43.9|<0.0001
71918905|NCT01846208|143359714|SUPERIORITY||Risk Difference (RD)|17.7||||0.151|TWO_SIDED|95.0|-2.3|37.7|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||37.7|-2.3|0.151
71918906|NCT01846208|143359714|SUPERIORITY||Risk Difference (RD)|44.3||||0.002|TWO_SIDED|95.0|19.4|69.2|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized||69.2|19.4|0.002
71918907|NCT01846208|143359714|SUPERIORITY||Risk Difference (RD)|17.5||||0.181|TWO_SIDED|95.0|-6.3|41.3|||Barnard's Exact Test|||% participants desensitized to \>=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned||41.3|-6.3|0.181
71918908|NCT01846208|143359716|SUPERIORITY||Risk Difference (RD)|-50.2||||0.003|TWO_SIDED|95.0|-78.4|-21.9|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized||-21.9|-78.4|0.003
71918909|NCT01846208|143359716|SUPERIORITY||Risk Difference (RD)|33.7||||0.023|TWO_SIDED|95.0|7.2|60.1|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned||60.1|7.2|0.023
71918910|NCT01424306|143359718|OTHER|||||||0.403||||||P value for the time x diet interaction reflects overall comparison of 3 dietary phases by RM-ANOVA|RM-ANOVA|||RM-ANOVA||||0.403
71918911|NCT01424306|143359719|OTHER|RM-ANOVA||||||0.933||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.933
71918912|NCT01424306|143359720|OTHER|RM-ANOVA||||||0.196||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.196
71918913|NCT01424306|143359721|OTHER|RM-ANOVA||||||0.88||||||Reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.880
71918914|NCT01424306|143359722|OTHER|RM-ANOVA|||||<|0.001||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|Repeated measures ANOVA|||||||<0.001
71918915|NCT01424306|143359723|OTHER|RM-ANOVA||||||0.366||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.366
71918916|NCT01424306|143359724|OTHER|RM-ANOVA||||||0.387||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.387
71685621|NCT02494401|142889646|SUPERIORITY|||||||0.93||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.93
71918917|NCT01424306|143359725|OTHER|RM-ANOVA||||||0.476||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.476
71918918|NCT01424306|143359726|OTHER|RM-ANOVA||||||0.596||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.596
71918919|NCT01424306|143359727|OTHER|RM-ANOVA||||||0.492||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.492
71918920|NCT01424306|143359728|OTHER|RM-ANOVA||||||0.149||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.149
71918921|NCT01424306|143359729|OTHER|RM-ANOVA||||||0.056||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.056
71918922|NCT01424306|143359730|OTHER|RM-ANOVA||||||0.52||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA|||||||0.520
71918923|NCT00369928|143359731|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.88||||0.982|TWO_SIDED|80.0|0.56|1.38|||Cochran-Mantel-Haenszel|||||1.38|0.56|0.982
71918924|NCT00369928|143359731|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.79||||0.666|TWO_SIDED|80.0|0.5|1.25|||Cochran-Mantel-Haenszel|||||1.25|0.50|0.666
71918925|NCT01809327|143359739|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.657|-0.269|||Mixed Model for Repeated Measures (MMRM)|||||-0.269|-0.657|0.001
71918926|NCT01809327|143359739|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.67|-0.28|||Mixed Model for Repeated Measures (MMRM)|||||-0.280|-0.670|0.001
71918927|NCT01809327|143359739|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.594|-0.207|||Mixed Model for Repeated Measures (MMRM)|||||-0.207|-0.594|0.001
71918928|NCT01809327|143359739|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.557|-0.169|||Mixed Model for Repeated Measures (MMRM)|||||-0.169|-0.557|0.001
71918929|NCT01809327|143359739|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.258|0.133|||Mixed Model for Repeated Measures (MMRM)|||||0.133|-0.258|0.001
71918930|NCT01809327|143359739|NON_INFERIORITY_OR_EQUIVALENCE|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.11|STANDARD_ERROR_OF_MEAN|0.099||0.001|TWO_SIDED|95.0|-0.307|0.082|||Mixed Model for Repeated Measures (MMRM)|||||0.082|-0.307|0.001
71918931|NCT01809327|143359740|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.016|TWO_SIDED|95.0|-1.6|-0.2|||Mixed Model for Repeated Measures (MMRM)|||||-0.2|-1.6|0.016
71918932|NCT01809327|143359740|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.4||0.002|TWO_SIDED|95.0|-2.6|-1.1|||Mixed Model for Repeated Measures (MMRM)|||||-1.1|-2.6|0.002
71918933|NCT01809327|143359740|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6|||Mixed Model for Repeated Measures (MMRM)|||||-0.6|-2.1|0.001
71918934|NCT01809327|143359740|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.9|-1.4|||Mixed Model for Repeated Measures (MMRM)|||||-1.4|-2.9|0.001
71918935|NCT01809327|143359741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.027|TWO_SIDED|95.0|1.06|2.37|||Generalized Linear Mixed Model|||||2.37|1.06|0.027
71918936|NCT01809327|143359741|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21||||0.016|TWO_SIDED|95.0|1.46|3.33|||Generalized Linear Mixed Model|||||3.33|1.46|0.016
71918937|NCT01809327|143359742|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.91|STANDARD_ERROR_OF_MEAN|0.882||0.06|TWO_SIDED|95.0|-3.641|-0.182|||Mixed Model for Repeated Measures (MMRM)|||||-0.182|-3.641|0.060
71685622|NCT02494401|142889646|SUPERIORITY|||||||0.84||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.84
71918938|NCT01809327|143359742|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.31|STANDARD_ERROR_OF_MEAN|0.889||0.147|TWO_SIDED|95.0|-3.058|0.431|||Mixed Model for Repeated Measures (MMRM)|||||0.431|-3.058|0.147
71878235|NCT01390272|143276235|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.83|TWO_SIDED|95.0|0.7|1.6|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 6 months||1.6|0.7|0.83
71878236|NCT01390272|143276236|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|0.9||||0.53|TWO_SIDED|95.0|0.5|1.4|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 12 months||1.4|0.5|0.53
71878237|NCT01390272|143276237|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.5||||0.09|TWO_SIDED|95.0|0.9|2.3|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 18 months.||2.3|0.9|0.09
71878238|NCT01390272|143276240|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.7|1.5|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variable of diabetes status and diabetes control.||||1.5|0.7|0.95
71878239|NCT01390272|143276241|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.4||||0.12|TWO_SIDED|95.0|0.9|2.1|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link.Adjusted for baseline stratification variable of diabetes status and blood pressure control.||Comparison at 12 months||2.1|0.9|0.12
71878240|NCT01390272|143276242|NON_INFERIORITY_OR_EQUIVALENCE||Odds Ratio (OR)|1.2||||0.3|TWO_SIDED|95.0|0.8|1.9|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status and blood pressure control.||Comparison at 18 months||1.9|0.8|0.30
71878241|NCT02887404|143276248|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.92|TWO_SIDED|95.0|-6.0|6.0|||t-test, 2 sided|||||6|-6|0.92
71878242|NCT02887404|143276249|NON_INFERIORITY|Delta: 15. The significance level for non-inferiority was 0.025|Median Difference (Final Values)|-9.0|||<|0.001|TWO_SIDED|95.0|-21.0|3.0|||Hodges-Lehmann estimator|||||3|-21|<0.001
71878243|NCT02887404|143276249|SUPERIORITY||Median Difference (Final Values)|-9.0||||0.175|TWO_SIDED|97.5|-23.0|5.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice.|Hodges-Lehmann estimator|||||5|-23|0.175
71878244|NCT02887404|143276250|NON_INFERIORITY|Delta: 1 The significance level for the non-inferiority test was 0.025.|Mean Difference (Final Values)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.8|1.0||This is a joint hypothesis testing. We tested non-inferiority on both secondary outcomes. If both showed significant non-inferiority, we tested superiority on both outcomes.|Regression, Linear|||||1|-0.8|<0.001
71878245|NCT02887404|143276250|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.094|TWO_SIDED|97.5|-0.8|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.1|-0.8|0.094
71878246|NCT02887404|143276268|NON_INFERIORITY|Delta: 9; significance level was 0.025|Median Difference (Final Values)|-0.1|||<|0.001|TWO_SIDED|95.0|-0.3|0.1|||Wilcoxon (Mann-Whitney)|||||0.1|-0.3|<0.001
71878247|NCT02887404|143276268|SUPERIORITY||Median Difference (Final Values)|-0.1||||0.171|TWO_SIDED|97.5|-0.3|0.1||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Wilcoxon sum rank test|||||0.1|-0.3|0.171
71878248|NCT02887404|143276269|NON_INFERIORITY|Delta: 1 significance level: 0.025|Mean Difference (Final Values)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.0|-0.1|||Regression, Linear||||The superiority test (this is a joint-hypothesis testing) showed a mean difference of -0.5 between treatment and control group with 97.5% CI of (-1.0, 0.0) and p-value of 0.025. The significance level was 0.025.|-0.1|-1.0|<0.001
71878249|NCT02887404|143276269|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.025|TWO_SIDED|97.5|-1.0|0.0||We adjusted for two outcomes for the superiority testing only, using a significance criterion of 0.0125 for each outcome (i.e., 0.025/2, Bonferroni correction), since superiority on either outcome would suffice|Regression, Linear|||||0.0|-1.0|0.025
71878250|NCT04305275|143276270|SUPERIORITY||Least Squares (LS) Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.533||0.0491|TWO_SIDED|95.0|-2.14|0.0|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||||0.00|-2.14|0.0491
71878251|NCT04305275|143276271|SUPERIORITY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.398||0.0468|TWO_SIDED|95.0|-1.6|-0.01|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.01|-1.60|0.0468
71878252|NCT04305275|143276271|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.467||0.3124|TWO_SIDED|95.0|-1.41|0.46|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||0.46|-1.41|0.3124
71878253|NCT04305275|143276271|SUPERIORITY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.605||0.5148|TWO_SIDED|95.0|-1.61|0.81|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||0.81|-1.61|0.5148
71918939|NCT01809327|143359743|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|5.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|1.2|9.5|||ANCOVA|||||9.5|1.2|0.147
71918940|NCT01809327|143359743|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|2.1||0.147|TWO_SIDED|95.0|0.2|8.5|||ANCOVA|||||8.5|0.2|0.147
71918941|NCT01809327|143359744|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|-3.7||||0.608|TWO_SIDED|95.0|-11.1|3.4|||Wilcoxon (Mann-Whitney)|||||3.4|-11.1|0.608
71918942|NCT01809327|143359744|SUPERIORITY_OR_OTHER||Hodges-Lehman Estimate|1.3||||0.806|TWO_SIDED|95.0|-7.3|10.0|||Wilcoxon (Mann-Whitney)|||||10.0|-7.3|0.806
71918943|NCT04957745|143359765|OTHER||||||<|0.01||||||"Null hypothesis is that there is no difference in Percentage of Total Viewing Time that Peripheral Target is Perceived across visual confusion conditions."|ANOVA|||"Effect of visual confusion conditions (binocular, unilateral monocular, and bilateral monocular visual confusions) on Percentage of Total Viewing Time Peripheral Target is Perceived is analyzed by repeated measure (within-subject) ANOVA. The test was performed with a significance level of 0.05."||||<0.01
71685623|NCT02494401|142889647|SUPERIORITY|||||||0.83||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.83
71685624|NCT02494401|142889647|SUPERIORITY|||||||0.27||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.27
71878254|NCT04305275|143276271|SUPERIORITY||LS mean difference|-0.27|STANDARD_ERROR_OF_MEAN|0.59||0.6452|TWO_SIDED|95.0|-1.45|0.91|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||0.91|-1.45|0.6452
71878255|NCT04305275|143276271|SUPERIORITY||LS mean difference|-0.77|STANDARD_ERROR_OF_MEAN|0.482||0.1171|TWO_SIDED|95.0|-1.73|0.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||0.20|-1.73|0.1171
71878256|NCT04305275|143276271|SUPERIORITY||LS mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.557||0.2724|TWO_SIDED|95.0|-0.5|1.73|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||1.73|-0.50|0.2724
71878257|NCT04305275|143276272|SUPERIORITY||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.658||0.8784|TWO_SIDED|95.0|-1.42|1.21|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||1.21|-1.42|0.8784
71878258|NCT04305275|143276272|SUPERIORITY||LS mean difference|0.93|STANDARD_ERROR_OF_MEAN|0.687||0.1795|TWO_SIDED|95.0|-0.44|2.3|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||2.30|-0.44|0.1795
71878259|NCT04305275|143276272|SUPERIORITY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.829||0.5588|TWO_SIDED|95.0|-2.15|1.17|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.17|-2.15|0.5588
71878260|NCT04305275|143276272|SUPERIORITY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.796||0.5036|TWO_SIDED|95.0|-1.06|2.13|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.13|-1.06|0.5036
71878261|NCT04305275|143276272|SUPERIORITY||LS mean difference|0.32|STANDARD_ERROR_OF_MEAN|0.736||0.6636|TWO_SIDED|95.0|-1.15|1.79|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||1.79|-1.15|0.6636
71878262|NCT04305275|143276272|SUPERIORITY||LS mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.756||0.3999|TWO_SIDED|95.0|-0.87|2.15|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.15|-0.87|0.3999
71878263|NCT04305275|143276272|SUPERIORITY||LS mean difference|0.67|STANDARD_ERROR_OF_MEAN|0.776||0.3933|TWO_SIDED|95.0|-0.88|2.22|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||2.22|-0.88|0.3933
71878264|NCT04305275|143276273|SUPERIORITY||LS mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.167||0.0193|TWO_SIDED|95.0|-5.14|-0.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||-0.47|-5.14|0.0193
71878265|NCT04305275|143276273|SUPERIORITY||LS mean difference|-2.95|STANDARD_ERROR_OF_MEAN|1.277||0.0243|TWO_SIDED|95.0|-5.51|-0.4|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15||-0.40|-5.51|0.0243
71685625|NCT02494401|142889647|SUPERIORITY|||||||0.18||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.18
71685626|NCT02494401|142889648|SUPERIORITY|||||||0.64||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.64
71685627|NCT02494401|142889648|SUPERIORITY|||||||0.8||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.8
71685628|NCT02494401|142889648|SUPERIORITY|||||||0.09||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.09
71685629|NCT02494401|142889649|SUPERIORITY|||||||0.73||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.73
71685630|NCT02494401|142889649|SUPERIORITY|||||||0.82||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.82
71685631|NCT02494401|142889649|SUPERIORITY|||||||0.04||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.04
71685632|NCT02494401|142889650|SUPERIORITY|||||||0.95||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.95
71685633|NCT02494401|142889650|SUPERIORITY|||||||0.87||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.87
71685634|NCT02494401|142889650|SUPERIORITY|||||||0.63||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.63
71878266|NCT04305275|143276273|SUPERIORITY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.209||0.0385|TWO_SIDED|95.0|-4.98|-0.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||-0.14|-4.98|0.0385
71685635|NCT02494401|142889651|SUPERIORITY|||||||0.05||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.05
71878267|NCT04305275|143276273|SUPERIORITY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|1.221||0.2682|TWO_SIDED|95.0|-3.81|1.08|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||1.08|-3.81|0.2682
71685636|NCT02494401|142889651|SUPERIORITY|||||||0.62||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.62
71685637|NCT02494401|142889651|SUPERIORITY|||||||0.7||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.7
71878268|NCT04305275|143276273|SUPERIORITY||LS mean difference|1.13|STANDARD_ERROR_OF_MEAN|1.233||0.3649|TWO_SIDED|95.0|-1.34|3.59|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||3.59|-1.34|0.3649
71685638|NCT02494401|142889652|SUPERIORITY|||||||0.29||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.29
71685639|NCT02494401|142889652|SUPERIORITY|||||||0.58||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.58
71685640|NCT02494401|142889652|SUPERIORITY|||||||0.49||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.49
71685641|NCT02494401|142889653|SUPERIORITY|||||||0.87||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)|||||||0.87
71685642|NCT02494401|142889653|SUPERIORITY|||||||0.89||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)|||||||0.89
71878269|NCT04305275|143276274|SUPERIORITY||LS mean difference|-1.26|STANDARD_ERROR_OF_MEAN|1.078||0.2478|TWO_SIDED|95.0|-3.41|0.9|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 8||0.90|-3.41|0.2478
71918944|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.9||||0.599|TWO_SIDED|95.0|0.39|2.07||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||2.07|0.39|0.599
71918945|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.07||||0.442|TWO_SIDED|95.0|0.43|2.59||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.59|0.43|0.442
71918946|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.68||||0.823|TWO_SIDED|95.0|0.3|1.57||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.57|0.30|0.823
71918947|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.69|TWO_SIDED|95.0|0.33|1.97||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.97|0.33|0.690
71918948|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.75||||0.764|TWO_SIDED|95.0|0.33|1.71||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.71|0.33|0.764
71918949|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.841|TWO_SIDED|95.0|0.27|1.56||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.56|0.27|0.841
71918950|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.702|TWO_SIDED|95.0|0.35|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7.This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.81|0.35|0.702
71918951|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.91||||0.578|TWO_SIDED|95.0|0.33|2.47||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.47|0.33|0.578
71878270|NCT04305275|143276274|SUPERIORITY||LS mean difference|-0.91|STANDARD_ERROR_OF_MEAN|1.192||0.4486|TWO_SIDED|95.0|-3.29|1.47|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, Pre-dose||1.47|-3.29|0.4486
71685643|NCT02494401|142889653|SUPERIORITY|||||||0.82||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)|||||||0.82
71685644|NCT01160380|142889677|SUPERIORITY_OR_OTHER|||||||0.289|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.289
71878271|NCT04305275|143276274|SUPERIORITY||LS mean difference|-1.52|STANDARD_ERROR_OF_MEAN|1.352||0.2662|TWO_SIDED|95.0|-4.22|1.19|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 5 Hours Post-dose||1.19|-4.22|0.2662
71918952|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.71||||0.783|TWO_SIDED|95.0|0.29|1.7||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.70|0.29|0.783
71918953|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.64||||0.797|TWO_SIDED|95.0|0.22|1.87||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.87|0.22|0.797
71918954|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.58||||0.919|TWO_SIDED|95.0|0.27|1.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.26|0.27|0.919
71918955|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.55||||0.892|TWO_SIDED|95.0|0.21|1.43||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.43|0.21|0.892
71918956|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.47||||0.86|TWO_SIDED|95.0|0.11|1.93||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.|||1.93|0.11|0.860
71685645|NCT01160380|142889677|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and Day 28||||<0.001
71685646|NCT01160380|142889677|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and day 28||||<0.002
71685647|NCT01160380|142889677|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the armodafinil arm||||0.449
71685648|NCT01160380|142889678|SUPERIORITY_OR_OTHER|||||||0.954|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment||||0.954
71685649|NCT01160380|142889678|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.007
71685650|NCT01160380|142889678|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.369
71685651|NCT01160380|142889678|SUPERIORITY_OR_OTHER|||||||0.973|TWO_SIDED||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm||||0.973
71685652|NCT01160380|142889679|SUPERIORITY_OR_OTHER|||||||0.699|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms at day 28||||0.699
71685653|NCT01160380|142889679|SUPERIORITY_OR_OTHER|||||||0.984|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm||||0.984
71685654|NCT01160380|142889679|SUPERIORITY_OR_OTHER|||||||0.239|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm||||0.239
71685655|NCT01160380|142889679|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.089
71685656|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.636|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test||||0.636
71685657|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test||||0.531
71685658|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test||||0.037
71685659|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.656|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test||||0.656
71685660|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.028
71878272|NCT04305275|143276274|SUPERIORITY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|1.282||0.9965|TWO_SIDED|95.0|-2.56|2.57|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 15, 8 Hours Post-dose||2.57|-2.56|0.9965
71685661|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.805|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.805
71685662|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.692|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test||||0.692
71685663|NCT01160380|142889680|SUPERIORITY_OR_OTHER|||||||0.863|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test||||0.863
71685664|NCT01160380|142889681|SUPERIORITY_OR_OTHER|||||||0.559|TWO_SIDED||||||t-test, 2 sided|||Comparison between arms for Day 28 of treatment- FACIT-F total||||0.559
71685665|NCT01160380|142889681|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total||||<0.001
71685666|NCT01160380|142889681|SUPERIORITY_OR_OTHER|||||||0.192|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total||||0.192
71685667|NCT01160380|142889681|SUPERIORITY_OR_OTHER|||||||0.495|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total||||0.495
71685668|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.945|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS anxiety||||0.945
71685669|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.316|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS depression||||0.316
71685670|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety||||0.005
71685671|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.005
71685672|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety||||0.001
71685673|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression||||0.315
71685674|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.933|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety||||0.933
71685675|NCT01160380|142889682|SUPERIORITY_OR_OTHER|||||||0.378|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression||||0.378
71685676|NCT01160380|142889683|SUPERIORITY_OR_OTHER|||||||0.84|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for Day 28 of treatment -ESS||||0.840
71685677|NCT01160380|142889683|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS||||0.050
71685678|NCT01160380|142889683|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||Day 1 and Day 28 of treatment for the Armodafinil arm- ESS||||0.051
71685679|NCT01160380|142889683|SUPERIORITY_OR_OTHER|||||||0.635|TWO_SIDED||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm||||0.635
71685680|NCT03046056|142889701|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-16.5|32.1||||||||32.1|-16.5|
71685681|NCT03046056|142889701|SUPERIORITY||Risk Difference in Proportions|8.3|||||TWO_SIDED|90.0|-15.9|32.0||||||||32.0|-15.9|
71685682|NCT03046056|142889702|SUPERIORITY||Least Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|90.0|-5.3|0.7||||||Difference in least squared means (Diff in LSM), and its 90% confidence interval (CI) were from analysis of covariance (ANCOVA) model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-5.3|
71685683|NCT03046056|142889702|SUPERIORITY||Least Squares Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-2.7|3.1||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||3.1|-2.7|
71918957|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.05||||0.463|TWO_SIDED|95.0|0.38|2.86||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.|||2.86|0.38|0.463
71918958|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.35||||0.932|TWO_SIDED|95.0|0.09|1.42||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.|||1.42|0.09|0.932
71918959|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.952|TWO_SIDED|95.0|0.16|1.17||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.|||1.17|0.16|0.952
71918960|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.873|TWO_SIDED|95.0|0.12|1.81||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.|||1.81|0.12|0.873
71918961|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.43||||0.953|TWO_SIDED|95.0|0.16|1.16||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.|||1.16|0.16|0.953
71918962|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.26||||0.281|TWO_SIDED|95.0|0.56|2.82||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.82|0.56|0.281
71918963|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.0||||0.5|TWO_SIDED|95.0|0.42|2.35||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||2.35|0.42|0.500
71918964|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.76||||0.744|TWO_SIDED|95.0|0.32|1.77||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||1.77|0.32|0.744
71918965|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.21||||0.334|TWO_SIDED|95.0|0.49|3.04||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||3.04|0.49|0.334
71918966|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.81||||0.698|TWO_SIDED|95.0|0.35|1.85||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.85|0.35|0.698
71918967|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.18||||0.353|TWO_SIDED|95.0|0.48|2.88||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||2.88|0.48|0.353
71918968|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|1.01||||0.489|TWO_SIDED|95.0|0.45|2.26||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||2.26|0.45|0.489
71918969|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.46||||0.94|TWO_SIDED|95.0|0.17|1.23||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||1.23|0.17|0.940
71918970|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.01||||0.495|TWO_SIDED|95.0|0.42|2.4||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||2.40|0.42|0.495
71918971|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.82||||0.647|TWO_SIDED|95.0|0.28|2.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.37|0.28|0.647
71918972|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.87||||0.646|TWO_SIDED|95.0|0.4|1.86||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||1.86|0.40|0.646
71918973|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.74||||0.741|TWO_SIDED|95.0|0.29|1.9||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.90|0.29|0.741
71918974|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio9|2.18||||0.109|TWO_SIDED|95.0|0.62|7.95||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.|||7.95|0.62|0.109
71918975|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.37||||0.24|TWO_SIDED|95.0|0.55|3.45||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.|||3.45|0.55|0.240
71685684|NCT03046056|142889703|SUPERIORITY||Least Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.38|||TWO_SIDED|90.0|-3.9|0.7||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||0.7|-3.9|
71918976|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.1||||0.447|TWO_SIDED|95.0|0.27|4.44||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.|||4.44|0.27|0.447
71918977|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|1.03||||0.472|TWO_SIDED|95.0|0.39|2.74||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.|||2.74|0.39|0.472
71918978|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.78||||0.698|TWO_SIDED|95.0|0.21|2.9||Posterior Probability the True Treatment Ratio \<1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.|||2.90|0.21|0.698
71918979|NCT02130635|143359809|SUPERIORITY_OR_OTHER||Adjusted Median Ratio|0.53||||0.911|TWO_SIDED|95.0|0.21|1.37||Posterior Probability the True Treatment Ratio \<1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.|||1.37|0.21|0.911
71918980|NCT02608892|143359832|SUPERIORITY|Use of pain management during newborn screening was described using frequency and proportion and expressed as an absolute difference in proportions with 95% confidence interval.|Absolute difference in proportions|-7.4|||||TWO_SIDED|95.0|-26.2|11.5||||||||11.5|-26.2|
71918981|NCT02590406|143359844|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||ANOVA|||We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.||||0.005
71918982|NCT02590406|143359845|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71918983|NCT02590406|143359846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||ANOVA|||||||0.0003
71918984|NCT02590406|143359847|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||ANOVA|||||||0.9
71918985|NCT02590406|143359848|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||ANOVA|||||||0.03
71918986|NCT00957723|143359851|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1 year, 2 year and 5 year||||<0.0001
71918987|NCT00957723|143359852|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||Change from pre-op to 1, 2, and 5 year||||<0.0001
71918988|NCT00957723|143359854|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||SF36 Physical Component Score change from preop to 1 year||||<0.0001
71685685|NCT03046056|142889703|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|90.0|-3.2|1.2||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||1.2|-3.2|
71685686|NCT03046056|142889704|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-2.2|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-2.2|
71685687|NCT03046056|142889704|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-1.9|2.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||2.0|-1.9|
71685688|NCT03046056|142889705|SUPERIORITY||Risk Difference in Proportions|-1.7|||||TWO_SIDED|90.0|-28.6|25.5||||||||25.5|-28.6|
71685689|NCT03046056|142889705|SUPERIORITY||Risk Difference in Proportions|0.4|||||TWO_SIDED|90.0|-24.5|26.2||||||||26.2|-24.5|
71878273|NCT04305275|143276274|SUPERIORITY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|1.222||0.8437|TWO_SIDED|95.0|-2.68|2.2|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 22||2.20|-2.68|0.8437
71878274|NCT04305275|143276274|SUPERIORITY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|1.232||0.796|TWO_SIDED|95.0|-2.78|2.14|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 29||2.14|-2.78|0.7960
71685690|NCT03046056|142889706|SUPERIORITY||Risk Difference in Proportions|-6.7|||||TWO_SIDED|90.0|-47.3|37.0||||||||37.0|-47.3|
71878275|NCT04305275|143276274|SUPERIORITY||LS mean difference|2.28|STANDARD_ERROR_OF_MEAN|1.119||0.0456|TWO_SIDED|95.0|0.05|4.52|||MMRM|MMRM model included treatment, baseline score, assessment timepoint, \& timepoint-by-treatment as explanatory variables, treated as fixed effects.||Change From Baseline at Day 42||4.52|0.05|0.0456
71878276|NCT00117598|143276276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.25|0.63|||Log Rank||HR from a cox model adjusted for baseline stratification factors|Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator's choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.||0.63|0.25|<0.0001
71878277|NCT00117598|143276276|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.41|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.65|0.26|<0.0001
71685691|NCT03046056|142889706|SUPERIORITY||Risk Difference in Proportions|-16.7|||||TWO_SIDED|90.0|-58.2|30.0||||||||30.0|-58.2|
71685692|NCT03046056|142889707|SUPERIORITY||Risk Difference in Proportions|33.3|||||TWO_SIDED|90.0|-32.4|86.5||||||||86.5|-32.4|
71685693|NCT03046056|142889708|SUPERIORITY||Risk Difference in Proportions|-2.3|||||TWO_SIDED|90.0|-28.6|24.3||||||||24.3|-28.6|
71685694|NCT03046056|142889708|SUPERIORITY||Risk Difference in Proportions|-15.0|||||TWO_SIDED|90.0|-39.4|11.3||||||||11.3|-39.4|
71685695|NCT03046056|142889709|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-38.9|45.7||||||||45.7|-38.9|
71878278|NCT00117598|143276277|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Fisher Exact|||||||0.0019
71878279|NCT00117598|143276277|SUPERIORITY_OR_OTHER|||||||0.6179|TWO_SIDED||||||Fisher Exact|||||||0.6179
71878280|NCT00117598|143276278|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.3053|TWO_SIDED|95.0|0.46|1.28|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.28|0.46|0.3053
71878281|NCT00117598|143276278|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.9515|TWO_SIDED|95.0|0.6|1.62|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.62|0.60|0.9515
71878282|NCT00117598|143276279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.14|9.01|||||HR from a cox model adjusted for baseline stratification factors|||9.01|0.14|
71878283|NCT00117598|143276279|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|95.0|0.1|13.3|||||HR from a cox model adjusted for baseline stratification factors|||13.3|0.10|
71685696|NCT03046056|142889709|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-47.5|40.8||||||||40.8|-47.5|
71685697|NCT03046056|142889710|SUPERIORITY||Risk Difference in Proportions|50.0|||||TWO_SIDED|90.0|-16.8|89.5||||||||89.5|-16.8|
71685698|NCT03046056|142889710|SUPERIORITY||Risk Difference in Proportions|12.5|||||TWO_SIDED|90.0|-46.1|63.3||||||||63.3|-46.1|
71685699|NCT03046056|142889711|SUPERIORITY||Risk Difference in Proportions|8.0|||||TWO_SIDED|90.0|-17.2|32.6||||||||32.6|-17.2|
71685700|NCT03046056|142889711|SUPERIORITY||Risk Difference in Proportions|6.3|||||TWO_SIDED|90.0|-18.1|30.2||||||||30.2|-18.1|
71685701|NCT03046056|142889712|SUPERIORITY||Risk Difference in Proportions|3.3|||||TWO_SIDED|90.0|-22.1|28.1||||||||28.1|-22.1|
71685702|NCT03046056|142889712|SUPERIORITY||Risk Difference in Proportions|-4.2|||||TWO_SIDED|90.0|-28.1|20.3||||||||20.3|-28.1|
71685703|NCT03046056|142889713|SUPERIORITY||Risk Difference in Proportions|17.1|||||TWO_SIDED|90.0|-7.6|40.4||||||||40.4|-7.6|
71685704|NCT03046056|142889713|SUPERIORITY||Risk Difference in Proportions|2.8|||||TWO_SIDED|90.0|-21.2|26.5||||||||26.5|-21.2|
71685705|NCT03046056|142889714|SUPERIORITY||Least Squares Mean Difference|-48.0|STANDARD_ERROR_OF_MEAN|28.1|||TWO_SIDED|90.0|-95.0|-1.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||-1|-95|
71685706|NCT03046056|142889714|SUPERIORITY||Least Squares Mean Difference|-31.0|STANDARD_ERROR_OF_MEAN|27.4|||TWO_SIDED|90.0|-76.0|15.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||15|-76|
71685707|NCT03046056|142889715|SUPERIORITY||Least Squares Mean Difference|-20.0|STANDARD_ERROR_OF_MEAN|28.7|||TWO_SIDED|90.0|-68.0|28.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||28|-68|
71685708|NCT03046056|142889715|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|28.0|||TWO_SIDED|90.0|-52.0|42.0||||||Diff in LSM, and its 90% CI were from ANCOVA model adjusted by baseline segmental MaRIA score, concomitant use of oral, systemically absorbed corticosteroids at baseline, concomitant use of immunomodulators at baseline, prior exposure to biologics, and treatment group.||42|-52|
71685709|NCT02913105|142889717|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.7489|TWO_SIDED|90.0|0.83|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||||1.13|0.83|0.7489
71685710|NCT02913105|142889717|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.72||||0.0005|TWO_SIDED|90.0|0.62|0.84|||ANCOVA|An unstructured variance-covariance structure was used.||||0.84|0.62|0.0005
71685711|NCT02913105|142889717|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.74||||0.0005|TWO_SIDED|90.0|0.65|0.85|||ANCOVA|An unstructured variance-covariance structure was used.||||0.85|0.65|0.0005
71685712|NCT02913105|142889722|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.95||||0.5354|TWO_SIDED|90.0|0.83|1.09|||ANCOVA|||||1.09|0.83|0.5354
71878284|NCT00117598|143276281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36|||<|0.0001|TWO_SIDED|95.0|0.23|0.56|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.56|0.23|<0.0001
71878285|NCT00117598|143276281|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39|||<|0.0001|TWO_SIDED|95.0|0.26|0.6|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.60|0.26|<0.0001
71685713|NCT02913105|142889722|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.68|||<|0.0001|TWO_SIDED|90.0|0.59|0.78|||ANCOVA|||||0.78|0.59|<.0001
71685714|NCT02913105|142889722|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.71|||<|0.0001|TWO_SIDED|90.0|0.63|0.8|||ANCOVA|||||0.80|0.63|<.0001
71878286|NCT00117598|143276282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.39||||0.0004|TWO_SIDED|95.0|0.23|0.67|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||0.67|0.23|0.0004
71878287|NCT00117598|143276282|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.0712|TWO_SIDED|95.0|0.4|1.04|||Log Rank||HR from a cox model adjusted for baseline stratification factors|||1.04|0.40|0.0712
71878288|NCT01536951|143276283|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|0.239|||||TWO_SIDED|90.0|-1.65|2.12|||||LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.12|-1.65|
71878289|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|1.81|||||TWO_SIDED|90.0|-0.079|3.69|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.69|-0.0790|
71878290|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS Mean Difference|1.44|||||TWO_SIDED|90.0|-0.446|3.32|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.32|-0.446|
71878291|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|0.468|||||TWO_SIDED|90.0|-1.42|2.35|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.35|-1.42|
71685715|NCT02913105|142889723|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.079|STANDARD_ERROR_OF_MEAN|0.389||0.8402|TWO_SIDED|90.0|-0.724|0.567|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.567|-0.724|0.8402
71878292|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|0.702|||||TWO_SIDED|90.0|-1.18|2.59|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.59|-1.18|
71878293|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|-0.788|||||TWO_SIDED|90.0|-2.68|1.1|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||1.10|-2.68|
71685716|NCT02913105|142889723|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.144|STANDARD_ERROR_OF_MEAN|0.472||0.7607|TWO_SIDED|90.0|-0.927|0.639|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.639|-0.927|0.7607
71685717|NCT02913105|142889723|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.228|STANDARD_ERROR_OF_MEAN|0.487||0.6406|TWO_SIDED|90.0|-1.037|0.581|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.581|-1.037|0.6406
71685718|NCT02913105|142889723|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.158|STANDARD_ERROR_OF_MEAN|0.685||0.8185|TWO_SIDED|90.0|-1.294|0.979|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.979|-1.294|0.8185
71878294|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|1.71|||||TWO_SIDED|90.0|-0.182|3.6|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||3.60|-0.182|
71878295|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|0.963|||||TWO_SIDED|90.0|-0.921|2.85|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||2.85|-0.921|
71878296|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|90.0|10.0|14.5|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||14.5|10.0|
71878297|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|11.0|||||TWO_SIDED|90.0|8.74|13.3|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.3|8.74|
71878298|NCT01536951|143276283|SUPERIORITY_OR_OTHER||LS mean difference|11.1|||||TWO_SIDED|90.0|8.87|13.4|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.|||13.4|8.87|
71878299|NCT03805750|143276292|OTHER|||||||0.52|||||||Regression, Logistic|||||||0.52
71878300|NCT04136184|143276330|SUPERIORITY||Difference in LS Mean|-24.7593||||1e-08|TWO_SIDED|95.0|-30.9552|-18.5635|||MMRM|||||-18.5635|-30.9552|0.00000001
71918989|NCT00957723|143359854|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Sign test|||SF36 Mental Component Score change from preop to 1 year||||0.0002
71918990|NCT00957723|143359854|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 2 years||||<0.0001
71918991|NCT00957723|143359854|SUPERIORITY_OR_OTHER|||||||0.0177|||||||Sign test|||SF36 Mental Component Score change from preop to 2 years||||0.0177
71878301|NCT04136184|143276331|SUPERIORITY||Difference in LS Mean|-19.7352||||1e-08|TWO_SIDED|95.0|-25.6301|-13.8403|||MMRM|||||-13.8403|-25.6301|0.00000001
71878302|NCT04136184|143276332|SUPERIORITY||Difference in LS Mean|-70.42||||1e-08|TWO_SIDED|95.0|-75.17|-65.66|||MMRM|||||-65.66|-75.17|0.00000001
71878303|NCT04136184|143276333|SUPERIORITY||Difference in LS Mean|-66.65||||1e-08|TWO_SIDED|95.0|-71.59|-61.71|||MMRM|||||-61.71|-71.59|0.00000001
71918992|NCT00957723|143359854|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 3 year||||<0.0001
71918993|NCT00957723|143359854|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Sign test|||SF36 Mental Component Score change from preop to 3 year||||0.0393
71878304|NCT04136184|143276334|SUPERIORITY||Difference in LS Mean|-9.3542||||0.00012203|TWO_SIDED|95.0|-13.8691|-4.8394|||MMRM|||||-4.8394|-13.8691|0.00012203
71878305|NCT04136184|143276335|SUPERIORITY||Difference in LS Mean|-11.8202||||1.873e-05|TWO_SIDED|95.0|-16.8927|-6.7477|||MMRM|||||-6.7477|-16.8927|0.00001873
71878306|NCT04136184|143276336|SUPERIORITY||Difference in LS Mean|-3.94||||0.00052447|TWO_SIDED|95.0|-6.08|-1.8|||MMRM|||Week 35||-1.80|-6.08|0.00052447
71878307|NCT04136184|143276336|SUPERIORITY||Difference in LS Mean|-8.21||||1e-08|TWO_SIDED|95.0|-10.65|-5.76|||MMRM|||Week 66||-5.76|-10.65|0.00000001
71878308|NCT04136184|143276337|SUPERIORITY||Difference in LS Mean|5.305||||5.58e-06|TWO_SIDED|95.0|3.195|7.416|||MMRM|||||7.416|3.195|0.00000558
71878309|NCT04136184|143276338|SUPERIORITY||Difference in LS Mean|-0.2||||0.02407897|TWO_SIDED|95.0|-0.4|0.0|||MMRM|||||-0.0|-0.4|0.02407897
71918994|NCT00957723|143359854|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 4 year||||<0.0001
71918995|NCT00957723|143359854|SUPERIORITY_OR_OTHER|||||||0.4905|||||||t-test, 2 sided|||SF36 Mental Component Score change from preop to 4 year||||0.4905
71918996|NCT00957723|143359854|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 5 year||||<0.0001
71918997|NCT00957723|143359854|SUPERIORITY_OR_OTHER|||||||0.0037|||||||Sign test|||SF36 Mental Component Score change from preop to 5 year||||0.0037
71918998|NCT00957723|143359856|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Sign test|||LEAS score change from preop to 1, 2, 3, 4, and 5 years||||<0.0001
71685719|NCT02913105|142889723|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.766||0.7804|TWO_SIDED|90.0|-1.485|1.057|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||1.057|-1.485|0.7804
71685720|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.598|STANDARD_ERROR_OF_MEAN|0.402||0.1403|TWO_SIDED|90.0|-1.265|0.07|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.070|-1.265|0.1403
71685721|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.49||0.0603|TWO_SIDED|90.0|-1.743|-0.117|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.117|-1.743|0.0603
71685722|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.344|STANDARD_ERROR_OF_MEAN|0.505||0.009|TWO_SIDED|90.0|-2.182|-0.506|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.506|-2.182|0.0090
71685723|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.787|STANDARD_ERROR_OF_MEAN|0.71||0.0134|TWO_SIDED|90.0|-2.965|-0.609|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.609|-2.965|0.0134
71685724|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-2.123|STANDARD_ERROR_OF_MEAN|0.793||0.0087|TWO_SIDED|90.0|-3.439|-0.807|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.807|-3.439|0.0087
71685725|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.519|STANDARD_ERROR_OF_MEAN|0.368||0.1609|TWO_SIDED|90.0|-1.13|0.091|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.091|-1.130|0.1609
71685726|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.786|STANDARD_ERROR_OF_MEAN|0.444||0.0797|TWO_SIDED|90.0|-1.524|-0.049|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.049|-1.524|0.0797
71878310|NCT04136184|143276339|SUPERIORITY||Difference in LS Mean|82.6991||||2e-07|TWO_SIDED|95.0|54.6431|110.7551|||MMRM|||||110.7551|54.6431|0.00000020
71878311|NCT03734016|143276391|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.12|||<|0.0001|TWO_SIDED|95.0|1.04|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.04|<0.0001
71878312|NCT03734016|143276391|SUPERIORITY|||||||0.0035||||||Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0035
71878313|NCT03734016|143276392|NON_INFERIORITY|Non-inferiority testing for ORR was performed using a stratified Wald test based on the stratified Mantel-Haenszel response ratio estimate against the non-inferiority margin of 0.8558 on the log scale.|Response ratio|1.14|||<|0.0001|TWO_SIDED|95.0|1.05|1.22|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Response ratio is the estimated ratio of the overall response rate of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.22|1.05|<0.0001
71878314|NCT03734016|143276392|SUPERIORITY|Superiority testing was performed using a 2-sided stratified Cochran-Mantel-Haenszel test.||||||0.0007|||||||Cochran-Mantel-Haenszel|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0007
71878315|NCT03734016|143276393|NON_INFERIORITY|Non-inferiority was tested with a non-inferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86|||Stratified Wald test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
71878316|NCT03734016|143276393|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
71685727|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.116|STANDARD_ERROR_OF_MEAN|0.455||0.0159|TWO_SIDED|90.0|-1.872|-0.36|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.360|-1.872|0.0159
71685728|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.63|STANDARD_ERROR_OF_MEAN|0.635||0.0118|TWO_SIDED|90.0|-2.684|-0.575|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.575|-2.684|0.0118
71685729|NCT02913105|142889723|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-1.909|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|90.0|-3.072|-0.746|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.746|-3.072|0.0076
71685730|NCT02913105|142889724|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.033|STANDARD_ERROR_OF_MEAN|0.137||0.8127|TWO_SIDED|90.0|-0.26|0.195|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.195|-0.260|0.8127
71685731|NCT02913105|142889724|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.023|STANDARD_ERROR_OF_MEAN|0.166||0.8901|TWO_SIDED|90.0|-0.298|0.252|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.252|-0.298|0.8901
71685732|NCT02913105|142889724|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.088|STANDARD_ERROR_OF_MEAN|0.177||0.6209|TWO_SIDED|90.0|-0.381|0.205|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.205|-0.381|0.6209
71685733|NCT02913105|142889724|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.238||0.8398|TWO_SIDED|90.0|-0.444|0.347|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.347|-0.444|0.8398
71685734|NCT02913105|142889724|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.073|STANDARD_ERROR_OF_MEAN|0.266||0.7839|TWO_SIDED|90.0|-0.515|0.369|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.369|-0.515|0.7839
71685735|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.241|STANDARD_ERROR_OF_MEAN|0.141||0.0911|TWO_SIDED|90.0|-0.476|-0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||-0.006|-0.476|0.0911
71685736|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.338|STANDARD_ERROR_OF_MEAN|0.172||0.052|TWO_SIDED|90.0|-0.623|-0.053|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.053|-0.623|0.0520
71878317|NCT03734016|143276394|NON_INFERIORITY|Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.|Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.49|0.86||Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)|Stratified Wald test||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.86|0.49|<0.0001
71878318|NCT03734016|143276394|SUPERIORITY|||||||0.0024|||||||Stratified Log-rank test|Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)||||||0.0024
71878319|NCT03734016|143276395|SUPERIORITY||Rate Difference|-8.0||||0.0004|TWO_SIDED|95.0|-12.4|-3.6|||Chi-squared||Rate difference is the zanubrutinib rate minus the ibrutinib rate.|||-3.6|-12.4|0.0004
71878320|NCT03734016|143276398|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.41|0.72|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||0.72|0.41|
71878321|NCT03734016|143276401|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.51|1.11|||||Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.|||1.11|0.51|
71918999|NCT00281528|143359863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4476||95.0||||Group comparison was performed between group 260 mg/m\^2 ABI-007 every 3 weeks and group 130 mg/m\^2 ABI-007 weekly, as based on amended protocol, no type I error adjustment for multiplicity; a priori threshold for statistical significance is 0.05.|Cochran-Mantel-Haenszel|Stratified by study site||||||0.4476
71685737|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.183||0.0085|TWO_SIDED|90.0|-0.793|-0.187|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.187|-0.793|0.0085
71685738|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.657|STANDARD_ERROR_OF_MEAN|0.247||0.0091|TWO_SIDED|90.0|-1.067|-0.247|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.247|-1.067|0.0091
71685739|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.759|STANDARD_ERROR_OF_MEAN|0.275||0.007|TWO_SIDED|90.0|-1.216|-0.302|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.302|-1.216|0.0070
71685740|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.208|STANDARD_ERROR_OF_MEAN|0.129||0.1092|TWO_SIDED|90.0|-0.423|0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.006|-0.423|0.1092
71685741|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.315|STANDARD_ERROR_OF_MEAN|0.156||0.0457|TWO_SIDED|90.0|-0.574|-0.056|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||-0.056|-0.574|0.0457
71685742|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.402|STANDARD_ERROR_OF_MEAN|0.165||0.0162|TWO_SIDED|90.0|-0.676|-0.129|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||-0.129|-0.676|0.0162
71878322|NCT03734016|143276402|OTHER||Least Squares (LS) Mean Difference|3.0||||0.0338|TWO_SIDED|95.0|0.23|5.77|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 24. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||5.77|0.23|0.0338
71878323|NCT03734016|143276402|OTHER||LS Mean Difference|1.34||||0.3304|TWO_SIDED|95.0|-1.37|4.06|||Mixed model for repeated measures (MMRM)|||Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL at Week 48. A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.||4.06|-1.37|0.3304
71878324|NCT03734016|143276402|OTHER||LS Mean Difference|1.82||||0.1189|TWO_SIDED|95.0|-0.47|4.12|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||4.12|-0.47|0.1189
71878325|NCT03734016|143276402|OTHER||LS Mean Difference|1.15||||0.3274|TWO_SIDED|95.0|-1.15|3.44|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.44|-1.15|0.3274
71878326|NCT03734016|143276402|OTHER||LS Mean Difference|0.63||||0.6821|TWO_SIDED|95.0|-2.4|3.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||3.66|-2.40|0.6821
71919000|NCT04396106|143359876|OTHER|||||||0.721|||||||Cochran-Mantel-Haenszel|||||||0.721
71878327|NCT03734016|143276402|OTHER||LS Mean Difference|1.8||||0.2701|TWO_SIDED|95.0|-1.4|5.0|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||5.00|-1.40|0.2701
71919001|NCT01628718|143359884|NON_INFERIORITY|The NI margin for CAPS-IV scores was established a priori, based on a calculation of a reliable difference from baseline to posttreatment CAPS-IV scores from a previous trial (10 points). If the 95% confidence interval (CI) around the estimate does not contain the NI margin, we can reject the null hypothesis and accept the alternative hypothesis. .|Mean Difference (Final Values)|0.33||||0.05|TWO_SIDED|95.0|-10.1|9.44||one-tailed|Regression, Linear||Mean difference is the difference in mean CAPS-IV change scores (pre-post) between AD and CPT-C.|Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-C||9.44|-10.10|.05
71919002|NCT01202643|143359896|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||ANCOVA|||||||0.67
71878328|NCT03734016|143276403|OTHER||LS Mean Difference|-1.91||||0.1778|TWO_SIDED|95.0|-4.7|0.87|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.87|-4.70|0.1778
71878329|NCT03734016|143276403|OTHER||LS Mean Difference|-0.35||||0.8174|TWO_SIDED|95.0|-3.32|2.62|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||2.62|-3.32|0.8174
71878330|NCT03734016|143276403|OTHER||LS Mean Difference|-0.29||||0.6294|TWO_SIDED|95.0|-1.48|0.89|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.89|-1.48|0.6294
71919003|NCT01202643|143359897|SUPERIORITY_OR_OTHER|||||||0.74|||||||Chi-squared, Corrected|||Study was closed due to insufficient recruitment||||0.74
71919004|NCT00537810|143359950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Chi-squared|df=3||Post-treatment||||0.60
71919005|NCT00537810|143359950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.13|||||||Chi-squared|df=3||6 month follow up||||0.13
71919006|NCT00537810|143359950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Chi-squared|df=3||12 month follow up||||0.29
71919007|NCT01711359|143359996|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is \>-12%|Newcombe-Wilson method|14.8|||||TWO_SIDED|95.0|5.5|24.1|||||Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).|||24.1|5.5|
71919008|NCT02698176|143360018|OTHER||Estimation of DLT Rate|0.25|||||TWO_SIDED|80.0|0.121|0.418|||||Point estimate and 2-sided 80% Bayesian credible interval for DLT rate estimated for the total number of participants from all 3 cohorts (CRPC+NMC+TNBC) that were evaluable for DLT analysis based on a non-informative prior distribution of Beta (1,1).|||0.418|0.121|
71878331|NCT03734016|143276403|OTHER||LS Mean Difference|-0.51||||0.4933|TWO_SIDED|95.0|-1.99|0.96|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.96|-1.99|0.4933
71919009|NCT02985684|143360060|OTHER|Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.|Binomial proportion|1.0|||<|0.0001|ONE_SIDED|95.0|0.974|||A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P \> 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1."|||0.974|<0.0001
71685743|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.608|STANDARD_ERROR_OF_MEAN|0.221||0.007|TWO_SIDED|90.0|-0.975|-0.242|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||-0.242|-0.975|0.0070
71878332|NCT03734016|143276403|OTHER||LS Mean Difference|-1.43||||0.3643|TWO_SIDED|95.0|-4.51|1.66|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||1.66|-4.51|0.3643
71919010|NCT02985684|143360061|OTHER|Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.|Binomial proportion|0.9|||<|0.0001|ONE_SIDED|95.0|0.843|||A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P \> 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1."|||0.843|<0.0001
71919011|NCT01436357|143360075|SUPERIORITY||Hazard Ratio (HR)|1.529||||0.317|TWO_SIDED|95.0|0.661|3.535|||Regression, Cox|||||3.535|0.661|0.317
71919012|NCT01436357|143360076|SUPERIORITY||Risk Difference (RD)|0.08||||0.029|TWO_SIDED|95.0|-0.01|0.16|||Fisher Exact|||||0.16|-0.01|0.029
71919013|NCT01436357|143360077|SUPERIORITY||Risk Difference (RD)|0.1||||0.015|TWO_SIDED|95.0|0.01|0.2|||Fisher Exact|||||0.20|0.01|0.015
71919014|NCT01436357|143360078|SUPERIORITY||Risk Difference (RD)|0.0||||0|TWO_SIDED||||||Fisher Exact|||||||0.00
71919015|NCT01436357|143360080|SUPERIORITY||Risk Difference (RD)|0.01||||0.499|TWO_SIDED|95.0|-0.08|0.1|||Fisher Exact|||||0.10|-0.08|0.499
71685744|NCT02913105|142889724|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.686|STANDARD_ERROR_OF_MEAN|0.244||0.006|TWO_SIDED|90.0|-1.091|-0.281|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||-0.281|-1.091|0.0060
71685745|NCT02913105|142889725|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.009||0.9927|TWO_SIDED|90.0|-0.015|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.014|-0.015|0.9927
71685746|NCT02913105|142889725|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.014|STANDARD_ERROR_OF_MEAN|0.013||0.2794|TWO_SIDED|90.0|-0.007|0.035|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.035|-0.007|0.2794
71685747|NCT02913105|142889725|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.007||0.9032|TWO_SIDED|90.0|-0.012|0.013|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.013|-0.012|0.9032
71685748|NCT02913105|142889725|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.009|STANDARD_ERROR_OF_MEAN|0.011||0.4163|TWO_SIDED|90.0|-0.009|0.027|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.027|-0.009|0.4163
71685749|NCT02913105|142889725|OTHER|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.004|STANDARD_ERROR_OF_MEAN|0.011||0.7001|TWO_SIDED|90.0|-0.022|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.014|-0.022|0.7001
71685750|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.009||0.5367|TWO_SIDED|90.0|-0.009|0.021|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.021|-0.009|0.5367
71685751|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5496|TWO_SIDED|90.0|-0.014|0.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.030|-0.014|0.5496
71685752|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.008||0.6844|TWO_SIDED|90.0|-0.01|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.016|-0.010|0.6844
71685753|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.011||0.5695|TWO_SIDED|90.0|-0.025|0.012|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.012|-0.025|0.5695
71685754|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.011||0.8015|TWO_SIDED|90.0|-0.021|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.016|-0.021|0.8015
71878333|NCT03734016|143276403|OTHER||LS Mean Difference|-2.43||||0.1363|TWO_SIDED|95.0|-5.62|0.77|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.77|-5.62|0.1363
71878334|NCT03734016|143276403|OTHER||LS Mean Difference|-1.59||||0.2001|TWO_SIDED|95.0|-4.01|0.84|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.84|-4.01|0.2001
71919016|NCT05281094|143360082|SUPERIORITY||Vaccine Efficacy|12.98|||||TWO_SIDED|95.0|-52.51|50.35|||||. Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||50.35|-52.51|
71878335|NCT03734016|143276403|OTHER||LS Mean Difference|-1.85||||0.1121|TWO_SIDED|95.0|-4.12|0.43|||Mixed model for repeated measures (MMRM)|||"Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.~A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix."||0.43|-4.12|0.1121
71919017|NCT05281094|143360083|SUPERIORITY||Vaccine Efficacy|17.02|||||TWO_SIDED|95.0|-24.52|44.7|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1||44.70|-24.52|
71919018|NCT05281094|143360084|SUPERIORITY||Vaccine Efficacy|13.91|||||TWO_SIDED|95.0|-34.7|44.98|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||44.98|-34.70|
71919019|NCT05281094|143360085|SUPERIORITY||Vaccine Efficacy|-6.37|||||TWO_SIDED|95.0|-45.04|22.0|||||Vaccine efficacy is demonstrated if the lower limit of the 95.0% CI is above 0%.|VE is defined 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates for the HIL-214 and placebo arms respectively, obtained via a stratified Cox proportional hazards model, using Efron's method for handling ties. The model includes a term for vaccine group and was stratified by country, whereby the United States, Dominican Republic, and Puerto Rico were considered one country. The 95% confidence interval as calculated by subtracting the confidence limits of hazard ratio from 1.||22.00|-45.04|
71878336|NCT00418665|143276440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||||95.0|0.07|5.136|||||Romiplostim/placebo|||5.136|0.070|
71878337|NCT00418665|143276440|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
71919020|NCT05315297|143360091|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71878338|NCT00418665|143276441|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo|||1.071|0.022|
71878339|NCT00418665|143276441|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.514||||||95.0|0.102|2.589|||||Romiplostim/placebo|||2.589|0.102|
71878340|NCT00418665|143276442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0||||||95.0|0.227|39.608|||||Romiplostim/placebo|||39.608|0.227|
71878341|NCT00418665|143276442|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.714||||||95.0|0.144|20.473|||||Romiplostim/placebo|||20.473|0.144|
71878342|NCT00418665|143276443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.911||||||95.0|0.097|8.529|||||Romiplostim/placebo|||8.529|0.097|
71919021|NCT05315297|143360092|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||||||0.13
71919022|NCT05315297|143360093|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71919023|NCT05315297|143360094|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||||||0.59
71919024|NCT05315297|143360095|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71919025|NCT05315297|143360096|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71919026|NCT03350724|143360116|SUPERIORITY|||||||0.039||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.039
71919027|NCT03350724|143360117|SUPERIORITY|||||||0.037||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.037
71919028|NCT03350724|143360118|SUPERIORITY|||||||0.032|||||||Z-Test for Two Population Proportions|||||||0.032
71919029|NCT03350724|143360119|SUPERIORITY|||||||0.171||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.171
71919030|NCT03350724|143360120|SUPERIORITY|||||||0.484||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.484
71919031|NCT03350724|143360121|SUPERIORITY|||||||0.368||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.368
71919032|NCT03350724|143360122|SUPERIORITY|||||||0.308||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.308
71919033|NCT03350724|143360123|SUPERIORITY|||||||0.999||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value||||||0.999
71919034|NCT03350724|143360124|SUPERIORITY|||||||0.015||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.015
71919035|NCT03350724|143360125|SUPERIORITY|||||||0.021||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.021
71919036|NCT03350724|143360126|SUPERIORITY|||||||0.035||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.035
71919037|NCT03350724|143360127|SUPERIORITY|||||||0.444||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.444
71919038|NCT03350724|143360128|SUPERIORITY|||||||0.765||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.765
71919039|NCT03350724|143360129|SUPERIORITY|||||||0.941||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.941
71919040|NCT03350724|143360130|SUPERIORITY|||||||0.421||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.421
71919041|NCT03350724|143360131|SUPERIORITY|||||||0.357||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value||||||0.357
71919042|NCT03350724|143360132|SUPERIORITY|||||||0.22||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.22
71919043|NCT03350724|143360133|SUPERIORITY|||||||0.882||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.882
71685755|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.006|STANDARD_ERROR_OF_MEAN|0.008||0.4923|TWO_SIDED|90.0|-0.008|0.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28||0.020|-0.008|0.4923
71685756|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.012||0.62|TWO_SIDED|90.0|-0.025|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||0.014|-0.025|0.6200
71685757|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.007||0.7423|TWO_SIDED|90.0|-0.009|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56||0.014|-0.009|0.7423
71685758|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|-0.016|STANDARD_ERROR_OF_MEAN|0.01||0.1272|TWO_SIDED|90.0|-0.032|0.001|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||0.001|-0.032|0.1272
71685759|NCT02913105|142889725|SUPERIORITY|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.01||0.8883|TWO_SIDED|90.0|-0.015|0.017|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)||0.017|-0.015|0.8883
71685760|NCT02913105|142889726|OTHER|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|1.01||||0.9514|TWO_SIDED|90.0|0.84|1.21|||ANCOVA|||||1.21|0.84|0.9514
71878343|NCT00418665|143276443|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.866||||||95.0|0.175|4.278|||||Romiplostim/placebo|||4.278|0.175|
71878344|NCT01133379|143276447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|4.75||0.811|TWO_SIDED|95.0|-10.5|8.24||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.24|-10.5|0.811
71878345|NCT01133379|143276447|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.75|STANDARD_ERROR_OF_MEAN|4.75||0.105|TWO_SIDED|95.0|-17.1|1.63||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 6 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.63|-17.1|0.105
71878346|NCT01133379|143276448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|3.969||0.779|TWO_SIDED|95.0|-6.72|8.95||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.95|-6.72|0.779
71878347|NCT01133379|143276448|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.92|STANDARD_ERROR_OF_MEAN|3.969||0.217|TWO_SIDED|95.0|-12.8|2.92||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.92|-12.8|0.217
71878348|NCT01133379|143276449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|2.613||0.904|TWO_SIDED|95.0|-4.84|5.47||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-019 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.47|-4.84|0.904
71919044|NCT03350724|143360134|SUPERIORITY|||||||0.64||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.64
71919045|NCT03350724|143360135|SUPERIORITY|||||||0.967||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.967
71685761|NCT02913105|142889726|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.5168|TWO_SIDED|90.0|0.78|1.12|||ANCOVA|||||1.12|0.78|0.5168
71919046|NCT03350724|143360136|SUPERIORITY|||||||0.375||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value||||||0.375
71685762|NCT02913105|142889726|SUPERIORITY|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.374|TWO_SIDED|90.0|0.8|1.07|||ANCOVA|||||1.07|0.80|0.3740
71919047|NCT02759939|143360147|SUPERIORITY||Odds Ratio (OR)|1.23||||0.8|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.80
71919048|NCT02759939|143360147|SUPERIORITY||Odds Ratio (OR)|1.47||||0.32|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.32
71919049|NCT02759939|143360147|SUPERIORITY||Odds Ratio (OR)|0.95||||0.99|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.99
71919050|NCT02759939|143360147|SUPERIORITY||Odds Ratio (OR)|0.8||||0.72|TWO_SIDED|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms||||||0.72
71919051|NCT03288987|143360168|NON_INFERIORITY|Noninferiority was declared by comparing the 90% CI for the hazard ratio (HR) of the AryoGen Pharmed Bevacizumab to the reference product (Roche Bevacizumab) to the point-estimate margin and was based on the synthesis method.|Hazard Ratio (HR)|0.79||||0.47|TWO_SIDED|90.0|0.46|1.35|||Regression, Cox|Upper limit of CI is lower than the noninferiority margin (1.44).|The 90 % CI based on synthesis method is (0.45,1.38). In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.35|0.46|0.47
71919052|NCT03288987|143360169|OTHER||Hazard Ratio (HR)|0.99||||0.99|TWO_SIDED|95.0|0.55|1.8|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.80|0.55|0.99
71919053|NCT03288987|143360170|OTHER|||||||0.17|||||||Fisher's Exact Test|||||||0.17
71919054|NCT03288987|143360171|OTHER||Hazard Ratio (HR)|1.11||||0.59|TWO_SIDED|95.0|0.76|1.61|||Regression, Cox||In HR calculation, the AryoGen Pharmed Bevacizumab to Roche Bevacizumab was reported. (reference group was Roche Bevacizumab)|||1.61|0.76|0.59
71919055|NCT03288987|143360172|OTHER||||||>|0.05|||||||Fisher's Exact Test|||||||>0.05
71919056|NCT04652102|143360191|SUPERIORITY||Proportion|0.364|||||TWO_SIDED|95.826|0.299|0.433|||||Derived from an exact 2-sided 95.826% Pearson-Clopper confidence interval (CI) on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.433|0.299|
71919057|NCT04652102|143360191|OTHER||Vaccine Efficacy|48.2||||0.016|TWO_SIDED|95.826|31.0|61.4||1-sided p-value from the exact binomial test on proportion of cases coming from the CVnCoV group among all cases (equivalent to a test on VE with H0: VE ≤30%). Statistically significant if lower than 0.02087.|Exact Binomial Test||2-sided 95.826% CI on VE, derived from the exact 2-sided 95.826% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Vaccine efficacy (VE) calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||61.4|31.0|0.01600
71919058|NCT04652102|143360203|SUPERIORITY||Proportion|0.245|||||TWO_SIDED|95.0|0.133|0.389|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.389|0.133|
71919059|NCT04652102|143360203|SUPERIORITY||Vaccine Efficacy|70.7|||||TWO_SIDED|95.0|42.5|86.1|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||86.1|42.5|
71919060|NCT04652102|143360204|SUPERIORITY||Proportion|0.286|||||TWO_SIDED|95.0|0.084|0.581|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.581|0.084|
71919061|NCT04652102|143360204|SUPERIORITY||Vaccine Efficacy|63.8|||||TWO_SIDED|95.0|-25.5|91.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||91.7|-25.5|
71919062|NCT04652102|143360205|SUPERIORITY||Proportion|0.341|||||TWO_SIDED|95.0|0.242|0.452|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.452|0.242|
71919063|NCT04652102|143360205|SUPERIORITY||Vaccine Efficacy|53.2|||||TWO_SIDED|95.0|25.4|71.2|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||71.2|25.4|
71919064|NCT04652102|143360206|SUPERIORITY||Proportion|0.571|||||TWO_SIDED|95.0|0.34|0.782|||||Derived from an exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|Proportion of cases coming from the CVnCoV group among all cases.||0.782|0.340|
71919065|NCT04652102|143360206|SUPERIORITY||Vaccine Efficacy|-11.8|||||TWO_SIDED|95.0|-200.5|56.7|||||2-sided 95% CI on VE, derived from the exact 2-sided 95% Pearson-Clopper CI on proportion of cases coming from the CVnCoV group among all cases.|VE calculated as VE = 1 - p/(1-p) \*1/r where p represents the proportion of cases coming from the CVnCoV group among all cases and r represents the ratio of total follow-up time of subjects in the CVnCoV group over the total follow-up time of subjects in the placebo group.||56.7|-200.5|
71685763|NCT02913105|142889727|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9453|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.9453
71685764|NCT02913105|142889727|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.4344|TWO_SIDED|90.0|0.96|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.01|0.96|0.4344
71685765|NCT02913105|142889727|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.639|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6390
71685766|NCT02913105|142889727|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.6329|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.02|0.97|0.6329
71685767|NCT02913105|142889727|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.664|TWO_SIDED|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42||1.02|0.97|0.6640
71685768|NCT02913105|142889727|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.7517|TWO_SIDED|90.0|0.98|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84||1.03|0.98|0.7517
71685769|NCT02913105|142889728|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.739|TWO_SIDED|90.0|0.77|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.19|0.77|0.7390
71685770|NCT02913105|142889728|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.3086|TWO_SIDED|90.0|0.72|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.08|0.72|0.3086
71685771|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.288|TWO_SIDED|90.0|0.69|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.08|0.69|0.2880
71685772|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.4446|TWO_SIDED|90.0|0.73|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.12|0.73|0.4446
71685773|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.4127|TWO_SIDED|90.0|0.73|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42||1.11|0.73|0.4127
71685774|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.8074|TWO_SIDED|90.0|0.85|1.25|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84||1.25|0.85|0.8074
71685775|NCT02913105|142889728|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6935|TWO_SIDED|90.0|0.88|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.08|0.88|0.6935
71685776|NCT02913105|142889728|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.9145|TWO_SIDED|90.0|0.9|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.09|0.90|0.9145
71685777|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.9131|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.12|0.91|0.9131
71878349|NCT01133379|143276449|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.99|STANDARD_ERROR_OF_MEAN|2.613||0.129|TWO_SIDED|95.0|-9.15|1.17||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p\<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.17|-9.15|0.129
71878350|NCT01133379|143276450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|1.336||0.477|TWO_SIDED|95.0|-3.59|1.69||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.69|-3.59|0.477
71878351|NCT01133379|143276450|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|1.336||0.472|TWO_SIDED|95.0|-3.6|1.67||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.67|-3.60|0.472
71878352|NCT01133379|143276451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|2.726||0.86|TWO_SIDED|95.0|-5.86|4.9||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.90|-5.86|0.860
71919066|NCT00886587|143360217|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.04||||0.9416|TWO_SIDED|95.0|-1.09|1.17||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.17|-1.09|0.9416
71878353|NCT01133379|143276451|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|2.723||0.763|TWO_SIDED|95.0|-6.2|4.55||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.55|-6.20|0.763
71878354|NCT01133379|143276452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.98|STANDARD_ERROR_OF_MEAN|2.856||0.488|TWO_SIDED|95.0|-7.62|3.66||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.66|-7.62|0.488
71878355|NCT01133379|143276452|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|2.854||0.311|TWO_SIDED|95.0|-8.54|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups||2.73|-8.54|0.311
71878356|NCT01133379|143276453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|3.478||0.604|TWO_SIDED|95.0|-8.68|5.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.06|-8.68|0.604
71878357|NCT01133379|143276453|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.91|STANDARD_ERROR_OF_MEAN|3.477||0.583|TWO_SIDED|95.0|-4.95|8.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.78|-4.95|0.583
71878358|NCT01133379|143276454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|3.61||0.847|TWO_SIDED|95.0|-7.83|6.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.43|-7.83|0.847
71878359|NCT01133379|143276454|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|3.61||0.708|TWO_SIDED|95.0|-5.77|8.48||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||8.48|-5.77|0.708
71878360|NCT01133379|143276455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.46|STANDARD_ERROR_OF_MEAN|2.678||0.36|TWO_SIDED|95.0|-7.75|2.83||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.83|-7.75|0.360
71878361|NCT01133379|143276455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|2.679||0.149|TWO_SIDED|95.0|-9.17|1.41||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.41|-9.17|0.149
71919067|NCT00886587|143360218|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.35||||0.5431|TWO_SIDED|95.0|-0.78|1.48||The significance level threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.48|-0.78|0.5431
71919068|NCT00886587|143360219|SUPERIORITY_OR_OTHER||Estimated Mean Difference|-0.06||||0.788|TWO_SIDED|95.0|-0.47|0.36||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment as a factor, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.36|-0.47|0.788
71685778|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9988|TWO_SIDED|90.0|0.91|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.91|0.9988
71685779|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.5873|TWO_SIDED|90.0|0.94|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42||1.13|0.94|0.5873
71878362|NCT01133379|143276456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.61|STANDARD_ERROR_OF_MEAN|3.235||0.421|TWO_SIDED|95.0|-9.0|3.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||3.78|-9.00|0.421
71878363|NCT01133379|143276456|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.66|STANDARD_ERROR_OF_MEAN|3.235||0.26|TWO_SIDED|95.0|-10.0|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.73|-10.0|0.260
71878364|NCT01133379|143276457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|3.601||0.989|TWO_SIDED|95.0|-7.16|7.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||7.06|-7.16|0.989
71878365|NCT01133379|143276457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|3.599||0.721|TWO_SIDED|95.0|-8.39|5.82||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.82|-8.39|0.721
71878366|NCT01133379|143276458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21|STANDARD_ERROR_OF_MEAN|3.69||0.743|TWO_SIDED|95.0|-8.5|6.07||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.07|-8.50|0.743
71878367|NCT01133379|143276458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|3.688||0.928|TWO_SIDED|95.0|-7.61|6.95||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||6.95|-7.61|0.928
71878368|NCT01133379|143276459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.369||0.683|TWO_SIDED|95.0|-3.71|5.65||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||5.65|-3.71|0.683
71878369|NCT01133379|143276459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|2.371||0.914|TWO_SIDED|95.0|-4.94|4.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.42|-4.94|0.914
71878370|NCT01133379|143276460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.19|STANDARD_ERROR_OF_MEAN|2.994||0.04|TWO_SIDED|95.0|-12.1|-0.27||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.27|-12.1|0.040
71878371|NCT01133379|143276460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|2.997||0.043|TWO_SIDED|95.0|-12.0|-0.18||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||-0.18|-12.0|0.043
71878372|NCT01133379|143276461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|3.522||0.511|TWO_SIDED|95.0|-9.27|4.64||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||4.64|-9.27|0.511
71919069|NCT00886587|143360220|SUPERIORITY_OR_OTHER||Estimated Mean Difference|0.03||||0.9508|TWO_SIDED|95.0|-0.9|0.96||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.96|-0.90|0.9508
71685780|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.905|TWO_SIDED|90.0|0.92|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84||1.10|0.92|0.9050
71685781|NCT02913105|142889728|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.1458|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.11|0.99|0.1458
71685782|NCT02913105|142889728|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.2048|TWO_SIDED|90.0|0.98|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.12|0.98|0.2048
71685783|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1051|TWO_SIDED|90.0|1.0|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.12|1.00|0.1051
71685784|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.0717|TWO_SIDED|90.0|1.01|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.15|1.01|0.0717
71685785|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8083|TWO_SIDED|90.0|0.96|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42||1.06|0.96|0.8083
71685786|NCT02913105|142889728|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.5361|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84||1.09|0.96|0.5361
71685787|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0858|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0858
71685788|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0096|TWO_SIDED|90.0|0.88|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||0.97|0.88|0.0096
71685789|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.0284|TWO_SIDED|90.0|0.88|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||0.98|0.88|0.0284
71685790|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.133|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.01|0.89|0.1330
71878373|NCT01133379|143276461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.07|STANDARD_ERROR_OF_MEAN|3.526||0.25|TWO_SIDED|95.0|-11.0|2.89||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.89|-11.0|0.250
71878374|NCT01133379|143276462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.41|STANDARD_ERROR_OF_MEAN|3.684||0.233|TWO_SIDED|95.0|-11.7|2.86||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||2.86|-11.7|0.233
71685791|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2032|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.01|0.89|0.2032
71878375|NCT01133379|143276462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.84|STANDARD_ERROR_OF_MEAN|3.687||0.115|TWO_SIDED|95.0|-13.1|1.44||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.||1.44|-13.1|0.115
71878376|NCT00841204|143276466|OTHER|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||||||0.0056
71878377|NCT00841204|143276467|OTHER|||||||0.386|||||||Wilcoxon (Mann-Whitney)|||||||0.386
71878378|NCT00841204|143276468|OTHER||||||<|0.05|||||||Regression, Linear|||||||<0.05
71878379|NCT00841204|143276469|OTHER|||||||0.58|||||||Regression, Linear|||||||0.58
71878380|NCT00841204|143276470|OTHER|||||||0.12|||||||Regression, Linear|||||||0.12
71878381|NCT05470465|143276479|SUPERIORITY||Mean Difference (Final Values)|-6.5|||<|0.001|ONE_SIDED|97.5||-3.1||To demonstrate an effect of oxycodone with paroxetine compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.1||<0.001
71685792|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1141|TWO_SIDED|90.0|0.87|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.00|0.87|0.1141
71878382|NCT05470465|143276479|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.001|ONE_SIDED|97.5||-2.1||To demonstrate an effect of oxycodone with escitalopram compared to oxycodone alone, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.001
71882627|NCT02706873|143284640|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.37|||<|0.001|TWO_SIDED|95.0|-0.47|-0.28||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.28|-0.47|<0.001
71685793|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1342|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.01|0.88|0.1342
71878383|NCT05470465|143276480|SUPERIORITY||Mean Difference (Final Values)|-6.5||||0.002|ONE_SIDED|97.5||-2.1||To demonstrate an effect of paroxetine compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.1||0.002
71878384|NCT05470465|143276480|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.5||To demonstrate an effect of escitalopram compared to placebo, it is necessary that the upper bound of the one-sided 97.5% confidence interval (CI) in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.5||0.003
71878385|NCT05470465|143276481|SUPERIORITY||Mean Difference (Final Values)|-7.1|||<|0.001|ONE_SIDED|97.5||-4.1||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-4.1||<0.001
71878386|NCT05470465|143276481|SUPERIORITY||Mean Difference (Final Values)|-5.6|||<|0.001|ONE_SIDED|97.5||-2.6||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and escitalopram compared to oxycodone and placebo at day 6 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.6||<0.001
71878387|NCT05470465|143276482|SUPERIORITY||Mean Difference (Final Values)|-10.1|||<|0.001|ONE_SIDED|97.5||-5.9||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and paroxetine compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-5.9||<0.001
71882628|NCT02706873|143284641|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|25.0|||<|0.001|TWO_SIDED|95.0|17.6|32.4||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||32.4|17.6|<0.001
71919070|NCT00696774|143360226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.005|TWO_SIDED|95.0|-1.12|-0.2|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.20|-1.12|0.005
71685794|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.0771|TWO_SIDED|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.00|0.92|0.0771
71685795|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.151|TWO_SIDED|90.0|0.91|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.01|0.91|0.1510
71882629|NCT02706873|143284641|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|26.4|||<|0.001|TWO_SIDED|95.0|19.0|33.9||The nominal p-value is reported|Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|||Response Rate Difference = Upadacitinib - Methotrexate|33.9|19.0|<0.001
71685796|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.0744|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.00|0.89|0.0744
71878388|NCT05470465|143276482|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.003|ONE_SIDED|97.5||-2.7||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of oxycodone and escitalopram compared to oxycodone, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of oxycodone and paroxetine compared to oxycodone and placebo at day 12 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-2.7||0.003
71878389|NCT05470465|143276483|SUPERIORITY||Mean Difference (Final Values)|-11.6|||<|0.001|ONE_SIDED|97.5||-6.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-6.5||<0.001
71878390|NCT05470465|143276483|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.001|ONE_SIDED|97.5||-9.0||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 5 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-9.0||<0.001
71878391|NCT05470465|143276484|SUPERIORITY||Mean Difference (Final Values)|-14.1|||<|0.001|ONE_SIDED|97.5||-8.5||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of paroxetine compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of paroxetine compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-8.5||<0.001
71878392|NCT05470465|143276484|SUPERIORITY||Mean Difference (Final Values)|-9.5|||<|0.001|ONE_SIDED|97.5||-3.8||Secondary analyses are not adjusted for multiplicity. To demonstrate an effect of escitalopram compared to placebo, the upper bound of the one-sided 97.5% CI in the least-square mean VE55 difference between treatments \< 0 L/min.|Mixed Models Analysis|The Kenward-Roger approximation will be used to estimate denominator degrees of freedom for tests of fixed effects.|Comparison was the effect of escitalopram compared to placebo at day 11 at 5 hours.|Sample size and power were calculated based on 2 primary outcomes (day 20 and day 21) with adjustment for multiplicity (α=.025). The assessments with paroxetine or escitalopram were considered as separate experiments. A sample size of 20 participants was determined to have 90 percent power at a 1-sided significance level to detect a 4 L/min decrease in the primary end point (ventilation at 55 mmHg end-tidal carbon dioxide) assuming a standard deviation of 5 L/min.||-3.8||<0.001
71878393|NCT02142738|143276485|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.68||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.68|0.37|<0.001
71878394|NCT02142738|143276486|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.002|TWO_SIDED|95.0|0.47|0.86||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||||0.86|0.47|0.002
71878395|NCT02142738|143276487|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentages|16.6||||0.0011|TWO_SIDED|95.0|6.0|27.0||One-sided p-value for testing|Miettinen & Nurminem method|Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||H0: difference in %=0 vs. H1: difference in % \>0||27.0|6.0|0.0011
71878396|NCT04490395|143276501|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.044|TWO_SIDED|95.0|-0.26|3.62|||t-test, 2 sided|||||3.62|-0.26|0.044
71878397|NCT04490395|143276502|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.056|TWO_SIDED|95.0|-0.15|1.33|||t-test, 2 sided|||||1.33|-0.15|0.056
71878398|NCT04490395|143276503|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.377|TWO_SIDED|95.0|-1.75|1.28|||t-test, 2 sided|||||1.28|-1.75|0.377
71878399|NCT04490395|143276504|SUPERIORITY|Within subjects change over time|F test (1,15) df|1.381||||0.258|TWO_SIDED||||||ANOVA|Change over time||Only 9 cases had any data available per group, and some had missing values and were not included in each analysis.|Within subjects change over time.|||0.258
71878400|NCT04490395|143276504|SUPERIORITY|Between group analysis|F test (1,15) df|0.246||||0.627|TWO_SIDED||||||ANOVA||||Between group analysis|||0.627
71878401|NCT04490395|143276504|SUPERIORITY||F test (1,15) df|0.005||||0.947|TWO_SIDED||||||ANOVA|||Time x Condition interaction|Time x Condition interaction|||0.947
71878402|NCT04490395|143276505|SUPERIORITY||Mean Difference (Final Values)|-0.88||||0.038|TWO_SIDED|95.0|-1.85|0.98|||t-test, 2 sided|||||0.98|-1.85|0.038
71878403|NCT04490395|143276506|SUPERIORITY||Mean Difference (Final Values)|-2.56||||0.07|TWO_SIDED|95.0|-6.05|0.94|||t-test, 2 sided|||||0.94|-6.05|0.07
71878404|NCT04490395|143276507|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.43|TWO_SIDED|95.0|-1.19|1.42|||t-test, 2 sided|||||1.42|-1.19|0.43
71878405|NCT04490395|143276508|SUPERIORITY||Mean Difference (Final Values)|-0.029||||0.72|TWO_SIDED|95.0|-0.194|1.42|||t-test, 2 sided|||||1.42|-.194|0.72
71878406|NCT04490395|143276509|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.341|TWO_SIDED|95.0|-0.35|0.23|||t-test, 2 sided|||||0.23|-0.35|0.341
71878407|NCT04490395|143276510|SUPERIORITY||Mean Difference (Final Values)|-0.059||||0.25|TWO_SIDED|95.0|-2.35|1.17|||t-test, 2 sided|||||1.17|-2.35|0.25
71878408|NCT00857532|143276515|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||Spearman's Rank Order Correlation|||"P-value for Attention correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score."||||0.021
71878409|NCT00857532|143276515|SUPERIORITY_OR_OTHER|||||||0.077||95.0|||||Spearman's Rank Order Correlation|||"P-value for Initiation/Perseveration correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score."||||0.077
71878410|NCT00857532|143276515|SUPERIORITY_OR_OTHER|||||||0.364||95.0|||||Spearman's Rank Order Correlation|||"P-value for Construction correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score."||||0.364
71878411|NCT00857532|143276515|SUPERIORITY_OR_OTHER|||||||0.266||95.0|||||Spearman's Rank Order Correlation|||"P-value for Conceptualization correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score."||||0.266
71878412|NCT00857532|143276515|SUPERIORITY_OR_OTHER|||||||0.152||95.0|||||Spearman's Rank Order Correlation|||"P-value for Memory correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score."||||0.152
71878413|NCT00857532|143276515|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||Spearman's Rank Order Correlation|||"P-value for DRS-2 Total correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score."||||0.041
71878414|NCT00857532|143276516|SUPERIORITY_OR_OTHER|||||||0.0411||95.0|||||Spearman's Rank Order Correlation|||"P-value for Amyloid beta correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta."||||0.0411
71878415|NCT00857532|143276516|SUPERIORITY_OR_OTHER|||||||0.58||95.0|||||Spearman's Rank Order Correlation|||"P-value for Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau."||||0.5800
71878416|NCT00857532|143276516|SUPERIORITY_OR_OTHER|||||||0.8164||95.0|||||Spearman's Rank Order Correlation|||"P-value for Phospho-Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau."||||0.8164
71878417|NCT00257725|143276517|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.09|STANDARD_DEVIATION|0.73||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
71878418|NCT00257725|143276518|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.64|STANDARD_DEVIATION|1.29||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
71878419|NCT00257725|143276519|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|10.55|STANDARD_DEVIATION|7.7||0.01|TWO_SIDED|95.0|||||paired t-test|||||||0.01
71878420|NCT01858532|143276520|OTHER||||||=|0.029|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.029
71878421|NCT01858532|143276520|OTHER||Hazard Ratio (HR)|0.654|||=|0.005|TWO_SIDED|95.0|0.488|0.878|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.878|0.488|=0.005
71878422|NCT01858532|143276521|OTHER||||||=|0.289|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||=0.289
71878423|NCT01858532|143276521|OTHER||Hazard Ratio (HR)|0.779||||0.112|TWO_SIDED|95.0|0.573|1.06|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.060|0.573|0.112
71878424|NCT01858532|143276522|OTHER|||||||0.089|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.089
71878425|NCT01858532|143276522|OTHER||Hazard Ratio (HR)|0.801||||0.049|TWO_SIDED|95.0|0.642|0.999|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.999|0.642|0.049
71878426|NCT01858532|143276523|OTHER||Hazard Ratio (HR)|0.72||||0.002|TWO_SIDED|95.0|0.58|0.89|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||0.89|0.58|0.002
71878427|NCT01858532|143276524|OTHER|||||||0.446|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.||||0.446
71878428|NCT01858532|143276524|OTHER||Hazard Ratio (HR)|0.884||||0.447|TWO_SIDED|95.0|0.643|1.215|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.||1.215|0.643|0.447
71878429|NCT00514514|143276525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.56|||<|0.0001|TWO_SIDED|95.0|2.82|8.31|||ANCOVA|||||8.31|2.82|< 0.0001
71878430|NCT01101438|143276578|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.93|TWO_SIDED|95.0|0.84|1.21|||Log Rank|||||1.21|0.84|0.93
71878431|NCT01101438|143276579|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.87|1.17|||Log Rank|||||1.17|0.87|0.94
71878432|NCT01101438|143276580|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.88|TWO_SIDED|95.0|0.83|1.24|||Log Rank|||||1.24|0.83|0.88
71882630|NCT02706873|143284642|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.25|||<|0.001|TWO_SIDED|95.0|3.0|5.5||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.50|3.00|<0.001
71878433|NCT00806195|143276613|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines-PRoutine Vaccines) was ≥ 6%.|Mean Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-0.8|6.4|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was \<6%.||6.4|-0.8|
71919071|NCT00696774|143360228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.85|||||TWO_SIDED|95.0|-7.34|-4.36|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-4.36|-7.34|
71919072|NCT00696774|143360229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.47|||||TWO_SIDED|95.0|-3.13|-1.81|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.81|-3.13|
71919073|NCT00696774|143360230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.29|||||TWO_SIDED|95.0|-4.1|-2.48|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.48|-4.10|
71919074|NCT00696774|143360231|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|||||TWO_SIDED|95.0|-2.89|-1.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.54|-2.89|
71919075|NCT00696774|143360232|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88|||||TWO_SIDED|95.0|-2.45|-1.3|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-1.30|-2.45|
71919076|NCT00696774|143360233|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||||TWO_SIDED|95.0|-1.31|-0.63|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.63|-1.31|
71919077|NCT00696774|143360234|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42|||||TWO_SIDED|95.0|-6.04|-2.8|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-2.80|-6.04|
71919078|NCT00696774|143360235|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|||||TWO_SIDED|95.0|-1.42|-0.84|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.84|-1.42|
71919079|NCT00696774|143360236|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|||||TWO_SIDED|95.0|-1.08|-0.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.24|-1.08|
71919080|NCT00696774|143360237|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|||||TWO_SIDED|95.0|-0.81|-0.18|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|||-0.18|-0.81|
71919081|NCT00696774|143360238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|||||TWO_SIDED|95.0|-0.99|2.6|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||2.60|-0.99|
71919082|NCT00696774|143360238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.69|3.42|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||3.42|-0.69|
71919083|NCT00696774|143360239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.05|||||TWO_SIDED|95.0|10.63|19.47|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||19.47|10.63|
71919084|NCT00696774|143360239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.48|||||TWO_SIDED|95.0|4.72|16.24|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||16.24|4.72|
71919085|NCT00696774|143360240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.88|||||TWO_SIDED|95.0|-7.75|-4.02|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 4||-4.02|-7.75|
71919086|NCT00696774|143360240|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.59|||||TWO_SIDED|95.0|-6.65|-2.54|||Adjusted Repeated Measures Analysis|Model terms: baseline score \& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \& response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.|Week 8||-2.54|-6.65|
71919087|NCT03490734|143360251|SUPERIORITY|||||||0.52||||||Corrected for multiple comparisons by using the threshold free cluster enhancement, nonparametric thresholding algorithm in FMRIB Software Library (FSL), resulting in a family-wise error rate (FWE) corrected significance threshold of p-FWE\<0.05|ANCOVA|||Whole-brain analyses were used. No clusters of significant activation were detected.||||0.52
71882631|NCT02706873|143284642|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.34|||<|0.001|TWO_SIDED|95.0|3.09|5.59||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.59|3.09|<0.001
71685797|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.99||||0.8365|TWO_SIDED|90.0|0.93|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.06|0.93|0.8365
71882632|NCT02706873|143284643|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.92|||<|0.001|TWO_SIDED|95.0|-1.12|-0.71||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.71|-1.12|<0.001
71878434|NCT00806195|143276614|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was ≥5%.|Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|1.5|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.5|-0.9|
71878435|NCT00806195|143276614|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines - PRoutine Vaccines) was \<5%.|Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.8|1.3|||Miettinen and Nurminen|||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was \<5%.||1.3|-0.8|
71878436|NCT00139776|143276634|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||"Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.~Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level."||||<0.0001
71878437|NCT00139776|143276635|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|Log Rank|||Kaplan-Meier analysis||||<0.0001
71878438|NCT00139776|143276636|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
71878439|NCT00139776|143276637|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
71878440|NCT00139776|143276638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
71878441|NCT00139776|143276638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||<0.001
71878442|NCT00139776|143276638|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||<0.001
71878443|NCT00139776|143276638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.003
71878444|NCT00139776|143276638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.022
71878445|NCT00139776|143276638|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.047
71878446|NCT00139776|143276639|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4||||<0.001
71878447|NCT00139776|143276639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8||||0.001
71878448|NCT00139776|143276639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.096||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12||||0.096
71919088|NCT03490734|143360252|SUPERIORITY|||||||0.016||||||Corrected for multiple comparisons by using the threshold free cluster enhancement (TFCE), nonparametric thresholding algorithm in FSL, resulting in a family-wise error rate corrected significance threshold of p-FWE \< 0.05|ANCOVA|||||||0.016
71685798|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6091|TWO_SIDED|90.0|0.92|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.05|0.92|0.6091
71878449|NCT00139776|143276639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.338||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16||||0.338
71878450|NCT00139776|143276639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.832||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20||||0.832
71878451|NCT00139776|143276639|SUPERIORITY_OR_OTHER_LEGACY|||||||0.972||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24||||0.972
71878452|NCT00139776|143276640|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0046||95.0||||Overall p-value Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)||||||0.0046
71878453|NCT00139776|143276641|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0102||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0102
71878454|NCT00139776|143276642|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||0.0012
71878455|NCT00139776|143276643|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANOVA|Treatment as fixed effect||||||<0.0001
71919089|NCT02442765|143360271|SUPERIORITY||Least Squares Mean Difference|-4.0|||=|0.021|TWO_SIDED|95.0|-7.4|-0.6||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|mixed model repeated measures (MMRM)|||||-0.6|-7.4|=0.021
71919090|NCT02442765|143360271|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.731|TWO_SIDED|95.0|-3.9|2.7||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||2.7|-3.9|=0.731
71919091|NCT02442765|143360271|SUPERIORITY||Least Squares Mean Difference|-3.5|||=|0.157|TWO_SIDED|95.0|-8.4|1.4||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|||||1.4|-8.4|=0.157
71919092|NCT02442765|143360271|SUPERIORITY||Least Squares Mean Difference|-3.6|||=|0.15|TWO_SIDED|95.0|-8.4|1.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.3|-8.4|=0.150
71878456|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Total WOMAC score||||<0.001
71878457|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|0.71||||95.0|0.21|2.99|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Continuous use||2.99|0.21|
71878458|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.99|STANDARD_ERROR_OF_MEAN|0.71||||95.0|3.6|6.38|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Intermittent use||6.38|3.60|
71878459|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
71878460|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.06|0.67|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Continuous use||0.67|0.06|
71878461|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.18|STANDARD_ERROR_OF_MEAN|0.15||||95.0|0.88|1.49|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Intermittent use||1.49|0.88|
71878462|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||0.004
71878463|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.07||||95.0|-0.02|0.25|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Continuous use||0.25|-0.02|
71878464|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.07||||95.0|0.26|0.53|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Intermittent use||0.53|0.26|
71919093|NCT02442765|143360271|SUPERIORITY||MMRM weighted z-statistic|-2.65|||=|0.008|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|Sequential Parallel Comparison Design (SPCD) was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.008
71919094|NCT02442765|143360271|SUPERIORITY||MMRM weighted z-statistic|-1.26|||=|0.208|TWO_SIDED|||||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||||=0.208
71919095|NCT02442765|143360272|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.331|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.331
71919096|NCT02442765|143360272|SUPERIORITY||Least Squares Mean Difference|-0.1||||0.4|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|0.400
71878465|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||0.002
71878466|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.13|STANDARD_ERROR_OF_MEAN|0.51||||95.0|0.13|2.14|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Continuous use||2.14|0.13|
71878467|NCT00139776|143276644|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.43|STANDARD_ERROR_OF_MEAN|0.51||||95.0|2.42|4.43|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Intermittent use||4.43|2.42|
71878468|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2712||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep disturbance||||0.2712
71878469|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8737||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Snoring||||0.8737
71878470|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7703||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Awaken short of breath||||0.7703
71878471|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Quantity of sleep||||0.3769
71878472|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4075||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep adequacy||||0.4075
71878473|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5854||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Somnolence||||0.5854
71878474|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8358||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index I||||0.8358
71878475|NCT00139776|143276645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5878||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index II||||0.5878
71878476|NCT00139776|143276646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC total score||||<0.001
71685799|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.3621|TWO_SIDED|90.0|0.9|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.03|0.90|0.3621
71685800|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.5031|TWO_SIDED|90.0|0.91|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.04|0.91|0.5031
71685801|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9244|TWO_SIDED|90.0|0.96|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7||1.04|0.96|0.9244
71878477|NCT00139776|143276646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale||||<0.001
71878478|NCT00139776|143276646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale||||<0.001
71878479|NCT00139776|143276646|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale||||<0.001
71878480|NCT00139776|143276647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1437||95.0||||Threshold for statistical significance p\<0.05|Cochran-Mantel-Haenszel|by general association||Analysis across all 3 sleep scores for Period III||||0.1437
71878481|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical function||||<0.0001
71878482|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role physical||||<0.0001
71878483|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Bodily pain||||<0.0001
71878484|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3097||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||General health||||0.3097
71878485|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0139||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Vitality||||0.0139
71878486|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1303||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Social functioning||||0.1303
71919097|NCT02442765|143360272|SUPERIORITY||Least Squares Mean Difference|-0.6||||0.014|TWO_SIDED|95.0|-1.1|-0.1|||ANCOVA|||||-0.1|-1.1|0.014
71919098|NCT02442765|143360272|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.145|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|0.145
71685802|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.236|TWO_SIDED|90.0|0.99|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14||1.08|0.99|0.2360
71685803|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.699|TWO_SIDED|90.0|0.96|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28||1.07|0.96|0.6990
71685804|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.05||||0.159|TWO_SIDED|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42||1.11|0.99|0.1590
71685805|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4256|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56||1.09|0.97|0.4256
71685806|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.4901|TWO_SIDED|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84||1.09|0.96|0.4901
71878487|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1404||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role emotional||||0.1404
71685807|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.3648|TWO_SIDED|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)||1.09|0.97|0.3648
71685808|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.8891|TWO_SIDED|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||1.12|0.91|0.8891
71685809|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.4817|TWO_SIDED|90.0|0.85|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.07|0.85|0.4817
71685810|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.6022|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.6022
71685811|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.447|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.07|0.83|0.4470
71685812|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.4342|TWO_SIDED|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.07|0.83|0.4342
71878488|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4015||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental health||||0.4015
71878489|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical component summary||||<0.0001
71878490|NCT00139776|143276648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0301||95.0||||Threshold for statistical significance p\<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental component summary||||0.0301
71685813|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0891|TWO_SIDED|90.0|0.73|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||0.99|0.73|0.0891
71685814|NCT02913105|142889729|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.226|TWO_SIDED|90.0|0.77|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.04|0.77|0.2260
71685815|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.87||||0.0324|TWO_SIDED|90.0|0.78|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.97|0.78|0.0324
71878491|NCT00674583|143276650|NON_INFERIORITY|Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-5.25|5.75||||||To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference \[Nimenrix group minus Menjugate group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||5.75|-5.25|
71878492|NCT03861936|143276675|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on Cochran-Mantel-Haenszel (CMH) model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
71878493|NCT03861936|143276675|SUPERIORITY||Percentage Difference|69.6|||<|0.0001|TWO_SIDED|95.0|55.1|84.0||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||84.0|55.1|<.0001
71878494|NCT03861936|143276681|SUPERIORITY||Percentage Difference|48.4|||<|0.0001|TWO_SIDED|95.0|33.1|63.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||63.7|33.1|<.0001
71878495|NCT03861936|143276681|SUPERIORITY||Percentage Difference|45.7|||<|0.0001|TWO_SIDED|95.0|29.5|61.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||61.8|29.5|<.0001
71685816|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85||||0.0291|TWO_SIDED|90.0|0.76|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||0.96|0.76|0.0291
71878496|NCT03861936|143276682|SUPERIORITY||Percentage Difference|55.2|||<|0.0001|TWO_SIDED|95.0|39.6|70.8||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.8|39.6|<.0001
71878497|NCT03861936|143276682|SUPERIORITY||Percentage Difference|60.9|||<|0.0001|TWO_SIDED|95.0|45.1|76.7||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||76.7|45.1|<.0001
71878498|NCT03861936|143276683|SUPERIORITY||Percentage Difference|54.2|||<|0.0001|TWO_SIDED|95.0|37.9|70.5||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||70.5|37.9|<.0001
71878499|NCT03861936|143276683|SUPERIORITY||Percentage Difference|47.8|||<|0.0001|TWO_SIDED|95.0|30.1|65.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||65.6|30.1|<.0001
71878500|NCT03861936|143276684|SUPERIORITY||Percentage Difference|68.8|||<|0.0001|TWO_SIDED|95.0|54.5|83.1||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||83.1|54.5|<.0001
71878501|NCT03861936|143276684|SUPERIORITY||Percentage Difference|52.2|||<|0.0001|TWO_SIDED|95.0|34.8|69.6||P-values for between-treatment comparisons are based on CMH model stratified by baseline MMPS Grade (4 or 5).|Cochran-Mantel-Haenszel|||||69.6|34.8|<.0001
71878502|NCT03861936|143276685|SUPERIORITY||Least Squares (LS) Mean Difference|-5.82|STANDARD_ERROR_OF_MEAN|0.647|<|0.0001|TWO_SIDED|95.0|-7.1|-4.54||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.54|-7.10|<.0001
71878503|NCT03861936|143276685|SUPERIORITY||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.678|<|0.0001|TWO_SIDED|95.0|-7.15|-4.47||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-4.47|-7.15|<.0001
71878504|NCT03861936|143276686|SUPERIORITY||LS Mean Difference|-7.63|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001|TWO_SIDED|95.0|-9.12|-6.13||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.13|-9.12|<.0001
71878505|NCT03861936|143276686|SUPERIORITY||LS Mean Difference|-8.26|STANDARD_ERROR_OF_MEAN|0.793|<|0.0001|TWO_SIDED|95.0|-9.83|-6.69||The change from baseline was analyzed using ANCOVA with study intervention and investigator site as factors and baseline MMPS Grade as a covariate.|ANCOVA|||||-6.69|-9.83|<.0001
71878506|NCT02446314|143276706|SUPERIORITY||||||=|0.04|||||||Linear Mixed Model / Baseline Covariate|||||||= .04
71878507|NCT02446314|143276707|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
71878508|NCT02446314|143276708|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
71878509|NCT02446314|143276709|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
71878510|NCT02446314|143276710|SUPERIORITY||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate|||||||> .05
71878511|NCT00701090|143276720|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%, i.e., Sitagliptin was declared non-inferior to glimepiride if the upper limit of the two-sided 95% confidence interval for the between group difference (sitagliptin minus glimepiride) was less than 0.4%|Mean Difference (Net)|0.07|STANDARD_DEVIATION|0.7|||TWO_SIDED|95.0|-0.03|0.16|||||ANCOVA model with terms: treatment, country, and baseline HbA1c.|||0.16|-0.03|
71878512|NCT00701090|143276721|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_DEVIATION|28.8|||TWO_SIDED|95.0|-0.9|6.7|||||ANCOVA model terms: treatment, country, and baseline.|||6.7|-0.9|
71878513|NCT00701090|143276722|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-15.0|||<|0.001|TWO_SIDED|95.0|-19.3|-10.9|||Miettinen &Nurminen method||Miettinen \&Nurminen method was used for the 95% confidence interval|||-10.9|-19.3|<0.001
71878514|NCT00701090|143276723|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_DEVIATION|2.9|<|0.001|TWO_SIDED|95.0|-2.3|-1.6|||ANCOVA|Model terms: treatment, country, and baseline.|ANCOVA model terms: treatment, country, and baseline.|||-1.6|-2.3|<0.001
71878515|NCT00701090|143276724|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65|||||TWO_SIDED|95.0|0.47|0.9|||||The parameter estimate and 95% CI represent the odds of having A1C \<7.0% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.90|0.47|
71878516|NCT00701090|143276725|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.47|0.95|||||The parameter estimate and 95% CI represent the odds of having A1C \<6.5% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.|||0.95|0.47|
71878517|NCT00324753|143276726|SUPERIORITY|||||||0.005||||||p-value based on a test of any treatment difference by site.|Mixed Models Analysis|The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.||||||.005
71878518|NCT03962738|143276764|SUPERIORITY||Odds Ratio (OR)|3.46|||<|0.001|TWO_SIDED|95.0|2.17|5.54|||Regression, Logistic|||||5.54|2.17|<0.001
71919099|NCT02442765|143360272|SUPERIORITY||SPCD OLS weighted z-statistic|-2.51||||0.012|TWO_SIDED||||||ANCOVA||OLS = ordinary least squares|||||0.012
71919100|NCT02442765|143360272|SUPERIORITY||SPCD OLS weighted z-statistic|-1.66||||0.097|TWO_SIDED||||||ANCOVA|||||||0.097
71878519|NCT03962738|143276765|SUPERIORITY||||||<|0.001|||||||Cochran-Armitage Trend Test|||||||<.001
71878520|NCT03962738|143276766|SUPERIORITY||Odds Ratio (OR)|1.76||||0.037|TWO_SIDED|95.0|1.03|2.99|||Regression, Logistic|||||2.99|1.03|0.037
71878521|NCT03962738|143276766|SUPERIORITY||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.16|5.17|||Regression, Logistic|||||5.17|2.16|<0.001
71685817|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.5755|TWO_SIDED|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.09|0.84|0.5755
71878522|NCT03962738|143276766|SUPERIORITY||Odds Ratio (OR)|2.95|||<|0.001|TWO_SIDED|95.0|1.89|4.62|||Regression, Logistic|||||4.62|1.89|<0.001
71685818|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.307|TWO_SIDED|90.0|0.8|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.05|0.80|0.3070
71878523|NCT03962738|143276767|SUPERIORITY||Odds Ratio (OR)|1.49||||0.197|TWO_SIDED|95.0|0.81|2.72|||Regression, Logistic|||||2.72|0.81|0.197
71878524|NCT03962738|143276767|SUPERIORITY||Odds Ratio (OR)|1.59||||0.044|TWO_SIDED|95.0|1.01|2.5|||Regression, Logistic|||||2.50|1.01|0.044
71878525|NCT03962738|143276767|SUPERIORITY||Odds Ratio (OR)|1.75||||0.023|TWO_SIDED|95.0|1.08|2.83|||Regression, Logistic|||||2.83|1.08|0.023
71878526|NCT03962738|143276768|SUPERIORITY||Odds Ratio (OR)|1.52||||0.268|TWO_SIDED|95.0|0.73|3.17|||Regression, Logistic|||||3.17|0.73|0.268
71878527|NCT03962738|143276768|SUPERIORITY||Odds Ratio (OR)|2.19||||0.006|TWO_SIDED|95.0|1.26|3.82|||Regression, Logistic|||||3.82|1.26|0.006
71878528|NCT03962738|143276768|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.5|4.61|||Regression, Logistic|||||4.61|1.50|<0.001
71878529|NCT03962738|143276769|SUPERIORITY||Odds Ratio (OR)|1.26||||0.535|TWO_SIDED|95.0|0.61|2.58|||Regression, Logistic|||||2.58|0.61|0.535
71878530|NCT03962738|143276769|SUPERIORITY||Odds Ratio (OR)|1.77||||0.036|TWO_SIDED|95.0|1.04|3.03|||Regression, Logistic|||||3.03|1.04|0.036
71878531|NCT03962738|143276769|SUPERIORITY||Odds Ratio (OR)|1.93||||0.018|TWO_SIDED|95.0|1.12|3.33|||Regression, Logistic|||||3.33|1.12|0.018
71878532|NCT03962738|143276770|SUPERIORITY||Odds Ratio (OR)|1.67||||0.199|TWO_SIDED|95.0|0.76|3.65|||Regression, Logistic|||||3.65|0.76|0.199
71878533|NCT03962738|143276770|SUPERIORITY||Odds Ratio (OR)|1.33||||0.305|TWO_SIDED|95.0|0.77|2.32|||Regression, Logistic|||||2.32|0.77|0.305
71878534|NCT03962738|143276770|SUPERIORITY||Odds Ratio (OR)|1.26||||0.426|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|||||2.24|0.71|0.426
71878535|NCT03962738|143276771|SUPERIORITY||Odds Ratio (OR)|1.57||||0.135|TWO_SIDED|95.0|0.87|2.82|||Regression, Logistic|||||2.82|0.87|0.135
71878536|NCT03962738|143276771|SUPERIORITY||Odds Ratio (OR)|1.48||||0.08|TWO_SIDED|95.0|0.95|2.3|||Regression, Logistic|||||2.30|0.95|0.080
71878537|NCT03962738|143276771|SUPERIORITY||Odds Ratio (OR)|1.56||||0.061|TWO_SIDED|95.0|0.98|2.49|||Regression, Logistic|||||2.49|0.98|0.061
71878538|NCT03962738|143276772|SUPERIORITY||Odds Ratio (OR)|1.38||||0.342|TWO_SIDED|95.0|0.71|2.67|||Regression, Logistic|||||2.67|0.71|0.342
71878539|NCT03962738|143276772|SUPERIORITY||Odds Ratio (OR)|1.25||||0.377|TWO_SIDED|95.0|0.76|2.04|||Regression, Logistic|||||2.04|0.76|0.377
71878540|NCT03962738|143276772|SUPERIORITY||Odds Ratio (OR)|1.05||||0.862|TWO_SIDED|95.0|0.63|1.72|||Regression, Logistic|||||1.72|0.63|0.862
71878541|NCT03962738|143276774|SUPERIORITY||Odds Ratio (OR)|3.43||||0.112|TWO_SIDED|95.0|0.75|15.65|||Regression, Logistic|||||15.65|0.75|0.112
71878542|NCT03962738|143276774|SUPERIORITY||Odds Ratio (OR)|9.05|||<|0.001|TWO_SIDED|95.0|2.68|30.55|||Regression, Logistic|||||30.55|2.68|<0.001
71878543|NCT03962738|143276774|SUPERIORITY||Odds Ratio (OR)|10.19|||<|0.001|TWO_SIDED|95.0|3.01|34.55|||Regression, Logistic|||||34.55|3.01|<0.001
71878544|NCT03962738|143276775|SUPERIORITY||Odds Ratio (OR)|0.78||||0.343|TWO_SIDED|95.0|0.46|1.31|||Regression, Logistic|||||1.31|0.46|0.343
71878545|NCT03962738|143276775|SUPERIORITY||Odds Ratio (OR)|2.02|||<|0.001|TWO_SIDED|95.0|1.37|2.98|||Regression, Logistic|||||2.98|1.37|<0.001
71878546|NCT03962738|143276775|SUPERIORITY||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.2|||Regression, Logistic|||||3.20|1.42|<0.001
71878547|NCT03962738|143276776|SUPERIORITY||Odds Ratio (OR)|1.19||||0.605|TWO_SIDED|95.0|0.62|2.26|||Regression, Logistic|||||2.26|0.62|0.605
71878548|NCT03962738|143276776|SUPERIORITY||Odds Ratio (OR)|1.8||||0.015|TWO_SIDED|95.0|1.12|2.9|||Regression, Logistic|||||2.90|1.12|0.015
71878549|NCT03962738|143276776|SUPERIORITY||Odds Ratio (OR)|1.23||||0.432|TWO_SIDED|95.0|0.74|2.05|||Regression, Logistic|||||2.05|0.74|0.432
71878550|NCT03962738|143276777|SUPERIORITY||Odds Ratio (OR)|1.77||||0.166|TWO_SIDED|95.0|0.79|3.96|||Regression, Logistic|||||3.96|0.79|0.166
71878551|NCT03962738|143276777|SUPERIORITY||Odds Ratio (OR)|1.34||||0.396|TWO_SIDED|95.0|0.68|2.62|||Regression, Logistic|||||2.62|0.68|0.396
71878552|NCT03962738|143276777|SUPERIORITY||Odds Ratio (OR)|1.58||||0.181|TWO_SIDED|95.0|0.81|3.11|||Regression, Logistic|||||3.11|0.81|0.181
71878553|NCT03962738|143276778|SUPERIORITY||Odds Ratio (OR)|1.44||||0.233|TWO_SIDED|95.0|0.79|2.64|||Regression, Logistic|||||2.64|0.79|0.233
71878554|NCT03962738|143276778|SUPERIORITY||Odds Ratio (OR)|1.5||||0.092|TWO_SIDED|95.0|0.94|2.41|||Regression, Logistic|||||2.41|0.94|0.092
71878555|NCT03962738|143276778|SUPERIORITY||Odds Ratio (OR)|1.8||||0.017|TWO_SIDED|95.0|1.11|2.92|||Regression, Logistic|||||2.92|1.11|0.017
71878556|NCT03962738|143276779|SUPERIORITY|||||||0.724|||||||ANCOVA|||||||0.724
71878557|NCT03962738|143276779|SUPERIORITY|||||||0.24|||||||ANCOVA|||||||0.240
71878558|NCT03962738|143276779|SUPERIORITY|||||||0.548|||||||ANCOVA|||||||0.548
71878559|NCT03962738|143276780|SUPERIORITY|||||||0.719|||||||ANCOVA|||||||0.719
71878560|NCT03962738|143276780|SUPERIORITY|||||||0.823|||||||ANCOVA|||||||0.823
71878561|NCT03962738|143276780|SUPERIORITY|||||||0.612|||||||ANCOVA|||||||0.612
71878562|NCT03962738|143276781|SUPERIORITY||Odds Ratio (OR)|1.78||||0.037|TWO_SIDED|95.0|1.04|3.07|||Regression, Logistic|||||3.07|1.04|0.037
71878563|NCT03962738|143276781|SUPERIORITY||Odds Ratio (OR)|2.67|||<|0.001|TWO_SIDED|95.0|1.75|4.06|||Regression, Logistic|||||4.06|1.75|<.001
71878564|NCT03962738|143276781|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|2.11|5.06|||Regression, Logistic|||||5.06|2.11|<.001
71878565|NCT03962738|143276782|SUPERIORITY|||||||0.162|||||||ANOVA|||Work Functioning||||0.162
71878566|NCT03962738|143276782|SUPERIORITY|||||||0.356|||||||ANOVA|||Social Functioning||||0.356
71878567|NCT03962738|143276782|SUPERIORITY|||||||0.696|||||||ANOVA|||Energy and Vitality||||0.696
71878568|NCT03962738|143276782|SUPERIORITY|||||||0.914|||||||ANOVA|||Feelings and Concerns||||0.914
71878569|NCT03962738|143276782|SUPERIORITY|||||||0.226|||||||ANOVA|||Migraine Symptoms||||0.226
71878570|NCT03962738|143276782|SUPERIORITY|||||||0.31|||||||ANOVA|||Work Functioning||||0.310
71878571|NCT03962738|143276782|SUPERIORITY|||||||0.684|||||||ANOVA|||Social Functioning||||0.684
71878572|NCT03962738|143276782|SUPERIORITY|||||||0.864|||||||ANOVA|||Energy and Vitality||||0.864
71878573|NCT03962738|143276782|SUPERIORITY|||||||0.412|||||||ANOVA|||Feelings and Concerns||||0.412
71878574|NCT03962738|143276782|SUPERIORITY|||||||0.025|||||||ANOVA|||Migraine Symptoms||||0.025
71878575|NCT03962738|143276782|SUPERIORITY|||||||0.619|||||||ANOVA|||Work Functioning||||0.619
71878576|NCT03962738|143276782|SUPERIORITY|||||||0.824|||||||ANOVA|||Social Functioning||||0.824
71878577|NCT03962738|143276782|SUPERIORITY|||||||0.476|||||||ANOVA|||Energy and Vitality||||0.476
71878578|NCT03962738|143276782|SUPERIORITY|||||||0.352|||||||ANOVA|||Feelings and Concerns||||0.352
71878579|NCT03962738|143276782|SUPERIORITY|||||||0.044|||||||ANOVA|||Migraine Symptoms||||0.044
71878580|NCT00509067|143276784|SUPERIORITY|||||||0.93||||||alpha set at P \< .05|Mixed Models Analysis|Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.||||||0.93
71878581|NCT00509067|143276785|SUPERIORITY|||||||0.23||||||alpha level set at .05|Mixed Models Analysis|Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..||||||0.23
71878582|NCT00509067|143276785|SUPERIORITY|||||||0.23||||||alpha set at P\<0.05|Mixed Models Analysis|Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.||||||0.23
71878583|NCT00073528|143276897|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio wase based on the log-rank test.|||0.96|0.53|0.019
71878584|NCT00073528|143276898|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.019|TWO_SIDED|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio was based on the log-rank test.|||0.96|0.53|0.019
71878585|NCT01022242|143276932|SUPERIORITY_OR_OTHER|||||||0.8861|||||||ANCOVA|||||||0.8861
71878586|NCT03654976|143276933|SUPERIORITY||Rate ratio|0.89||||0.5412|TWO_SIDED|95.0|0.6|1.31|||Negative binomial regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The number of clinically relevant asthma exacerbations was analyzed using a negative binomial regression model with a log-link function and the logarithm of the time in years in the efficacy period as offset. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||1.31|0.60|0.5412
71878587|NCT03654976|143276934|SUPERIORITY||Odds Ratio (OR)|0.7713||||0.4156|TWO_SIDED|95.0|0.41|1.44|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.44|0.41|0.4156
71878588|NCT03654976|143276935|SUPERIORITY||Odds Ratio (OR)|0.8477||||0.4146|TWO_SIDED|95.0|0.57|1.26|||Marginal logistic regression||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|A marginal logistic regression model with a generalized estimating approach was analyzed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit is included as a covariate. No missing data approach was applied.||1.26|0.57|0.4146
71878589|NCT03654976|143276936|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.8829|TWO_SIDED|95.0|-1.47|1.7|||Mixed-effect model repeated measurement||12 SQ-HDM - placebo|A 'mixed-effect model repeated measurement' model was analysed using treatment, visit, treatment\*visit, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. Baseline visit was included as a covariate. No missing data approach was applied.||1.70|-1.47|0.8829
71878590|NCT03654976|143276937|SUPERIORITY||Odds Ratio (OR)|2.26||||0.0044|TWO_SIDED|95.0|1.29|3.96|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analyzed using a generalized linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||3.96|1.29|0.0044
71878591|NCT03654976|143276938|SUPERIORITY||Odds Ratio, log|1.62||||0.0698|TWO_SIDED|95.0|0.96|2.74|||Generalised linear mixed model||12 SQ-HDM SLIT-tablet as the numerator and placebo SLIT-tablet as the denominator.|The odds of having an improved outcome was analysed using a generalised linear mixed model (GLMM) with a logit link function. The model included treatment, age group (\<12 years, \>=12 years) and region (west: DEU, ESP, FRA, GBR and USA; central: POL; east: BGR, HUN and RUS) as fixed factors. No missing data approach was applied.||2.74|0.96|0.0698
71878592|NCT04688775|143276955|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.5048|TWO_SIDED|95.0|-1.3|2.6|||Mixed Models Repeated Measures|||Change From Baseline in the Number of Weekly Attacks: Eptinezumab vs. Placebo||2.6|-1.3|0.5048
71878593|NCT04688775|143276960|SUPERIORITY||Hazard Ratio (HR)|1.45||||0.0772|TWO_SIDED|95.0|0.96|2.17|||Regression, Cox|||||2.17|0.96|0.0772
71878594|NCT04261504|143277000|SUPERIORITY|||||||0.03||||||Threshold p\<0.05.|threshold-free cluster enhancement|||||||0.03
71878595|NCT00382018|143277008|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.69|1.47|||Log Rank|||Hazard Ration of overall survival compared Arm C2 to Arm C1.||1.47|0.69|0.98
71685819|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7752|TWO_SIDED|90.0|0.86|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.12|0.86|0.7752
71685820|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.1803|TWO_SIDED|90.0|0.75|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.03|0.75|0.1803
71685821|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.2414|TWO_SIDED|90.0|0.76|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.05|0.76|0.2414
71685822|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0179|TWO_SIDED|90.0|0.77|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7||0.95|0.77|0.0179
71685823|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.1125|TWO_SIDED|90.0|0.8|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14||1.00|0.80|0.1125
71685824|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9572|TWO_SIDED|90.0|0.88|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28||1.12|0.88|0.9572
71878596|NCT00382018|143277009|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.64|TWO_SIDED|95.0|0.64|1.32|||Log Rank|||Hazard Ratio of progression free survival compared Arm C2 to Arm C1||1.32|0.64|0.64
71685825|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7372|TWO_SIDED|90.0|0.87|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42||1.10|0.87|0.7372
71685826|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.6015|TWO_SIDED|90.0|0.92|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56||1.17|0.92|0.6015
71685827|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.03||||0.7261|TWO_SIDED|90.0|0.89|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84||1.19|0.89|0.7261
71878597|NCT00789880|143277014|SUPERIORITY_OR_OTHER|||||||0.7|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.||||0.7
71878598|NCT00789880|143277014|SUPERIORITY_OR_OTHER|||||||0.12|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.12
71878599|NCT00789880|143277015|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.3
71878600|NCT00789880|143277016|SUPERIORITY_OR_OTHER|||||||0.4|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
71878601|NCT00789880|143277016|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.2
71878602|NCT00789880|143277017|SUPERIORITY_OR_OTHER|||||||0.8|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.8
71919101|NCT02442765|143360273|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.182|TWO_SIDED|95.0|-1.3|0.2||MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use. Unstructured variance-covariance was used.|MMRM|SPCD was used with weight = 0.6 for Stage 1 and 0.4 for Stage 2.||||0.2|-1.3|=0.182
71685828|NCT02913105|142889729|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9892|TWO_SIDED|90.0|0.87|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)||1.15|0.87|0.9892
71685829|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0005|TWO_SIDED|90.0|0.87|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.95|0.87|0.0005
71878603|NCT00789880|143277017|SUPERIORITY_OR_OTHER|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.2
71685830|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.89||||0.0005|TWO_SIDED|90.0|0.84|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.94|0.84|0.0005
71685831|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0062|TWO_SIDED|90.0|0.86|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.96|0.86|0.0062
71878604|NCT00789880|143277018|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.4
71878605|NCT00789880|143277019|SUPERIORITY_OR_OTHER|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.4
71878606|NCT00789880|143277019|SUPERIORITY_OR_OTHER|||||||1||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||1.0
71878607|NCT00789880|143277020|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.||||0.2
71878608|NCT00789880|143277020|SUPERIORITY_OR_OTHER|||||||0.5||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.||||0.5
71878609|NCT00789880|143277021|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.||||0.7
71878610|NCT00789880|143277022|SUPERIORITY_OR_OTHER|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.||||0.2
71878611|NCT00789880|143277022|SUPERIORITY_OR_OTHER|||||||0.3||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.||||0.3
71878612|NCT00493220|143277031|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|111.79|||||TWO_SIDED|90.0|108.57|115.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||115.12|108.57|
71919102|NCT02442765|143360273|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.39|TWO_SIDED|95.0|-1.1|0.4||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.4|-1.1|=0.390
71878613|NCT00493220|143277031|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|60.81|||||TWO_SIDED|90.0|59.06|62.62|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||62.62|59.06|
71878614|NCT00493220|143277031|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|54.4|||||TWO_SIDED|90.0|52.82|56.01|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||56.01|52.82|
71878615|NCT00493220|143277032|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0|||<|0.01|TWO_SIDED|90.0|-1.25|-0.75|||Wilcoxon signed-rank test||HYLENEX SC minus Placebo SC|||-0.75|-1.25|<0.01
71878616|NCT00493220|143277032|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.52|||<|0.01|TWO_SIDED|90.0|1.27|1.71|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||1.71|1.27|<0.01
71878617|NCT00493220|143277032|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.52|||<|0.01|TWO_SIDED|90.0|2.26|2.76|||Wilcoxon signed-rank test||Placebo SC minus Intravenous|||2.76|2.26|<0.01
71878618|NCT00493220|143277033|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.99|||||TWO_SIDED|90.0|98.95|105.12|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||105.12|98.95|
71878619|NCT00493220|143277033|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.79|||||TWO_SIDED|90.0|103.61|110.07|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.07|103.61|
71878620|NCT00493220|143277033|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|104.71|||||TWO_SIDED|90.0|101.59|107.92|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||107.92|101.59|
71878621|NCT00493220|143277034|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.76|||||TWO_SIDED|90.0|98.64|104.98|||Schuirmann two one-sided tests procedure||HYLENEX SC/Placebo SC|||104.98|98.64|
71878622|NCT00493220|143277034|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.95|||||TWO_SIDED|90.0|103.67|110.33|||Schuirmann two one-sided tests procedure||HYLENEX SC/Intravenous|||110.33|103.67|
71878623|NCT00493220|143277034|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|105.1|||||TWO_SIDED|90.0|101.87|108.42|||Schuirmann two one-sided tests procedure||Placebo SC/Intravenous|||108.42|101.87|
71878624|NCT02568475|143277035|EQUIVALENCE|Continuous scale: score compares results before and after intervention without a cut parameter.|Mean Difference (Final Values)|3.59|STANDARD_ERROR_OF_MEAN|1.74||0.046|TWO_SIDED|95.0|0.059|7.12|||t-test, 2 sided|||||7.12|0.059|0.046
71878625|NCT02568475|143277036|OTHER|This is a continuous scale with no clinical cut score/value. We tested mean differences between the two groups.|Mean Difference (Final Values)|6.78||||0.001|TWO_SIDED|95.0|2.9|10.6|||t-test, 2 sided|||||10.6|2.9|0.001
71878626|NCT02426476|143277042|SUPERIORITY||||||<|0.01||||||Group by Time interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
71878627|NCT02426476|143277043|SUPERIORITY|||||||0.87||||||Group by Time interaction|Mixed Models Analysis|||||||0.87
71878628|NCT02426476|143277044|SUPERIORITY||||||<|0.01||||||Group by Time Interaction|Mixed Models Analysis|||Linear mixed models for repeated measures (PROC MIXED in SAS) were used to assess the effects of intervention group, time, and the group by time interaction. A directional (one-sided) hypothesis was tested for the Group-by-Time interaction. The covariance matrix that minimized the Akaike Information Criterion was used. Each outcome was evaluated separately. Models were adjusted for baseline depression score and race.||||<0.01
71878629|NCT01704287|143277045|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels \[≥110% Upper Limit of Normal (ULN)\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.73||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|||0.73|0.46|<0.0001
71878630|NCT01704287|143277045|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.47|||<|0.0001|TWO_SIDED|95.0|0.37|0.6||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|||0.60|0.37|<0.0001
71878631|NCT01704287|143277045|SUPERIORITY_OR_OTHER_LEGACY|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.83||||0.1247|TWO_SIDED|95.0|0.66|1.05||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|||1.05|0.66|0.1247
71878632|NCT01704287|143277046|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1173|TWO_SIDED|95.0|0.67|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.67|0.1173
71878633|NCT01704287|143277046|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.0106|TWO_SIDED|95.0|0.57|0.96||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.96|0.57|0.0106
71878634|NCT01704287|143277046|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.87||||0.2905|TWO_SIDED|95.0|0.67|1.12||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.12|0.67|0.2905
71878635|NCT01704287|143277047|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.86||||0.1146|TWO_SIDED|95.0|0.68|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.10|0.68|0.1146
71878636|NCT01704287|143277047|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0023|TWO_SIDED|95.0|0.55|0.9||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.90|0.55|0.0023
71878637|NCT01704287|143277047|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.149|TWO_SIDED|95.0|0.66|1.07||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.07|0.66|0.1490
71919103|NCT02442765|143360273|SUPERIORITY||Least Squares Mean Difference|0.5|||=|0.462|TWO_SIDED|95.0|-0.8|1.7||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.7|-0.8|=0.462
71919104|NCT02442765|143360273|SUPERIORITY||Least Squares Mean Difference|0.4|||=|0.528|TWO_SIDED|95.0|-0.8|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-0.8|=0.528
71878638|NCT01704287|143277048|SUPERIORITY_OR_OTHER_LEGACY|PD-L1-Positive Participants|Hazard Ratio (HR)|0.92||||0.3113|TWO_SIDED|95.0|0.66|1.28||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.28|0.66|0.3113
71878639|NCT01704287|143277048|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.7||||0.0208|TWO_SIDED|95.0|0.5|0.99||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||0.99|0.50|0.0208
71878640|NCT01704287|143277048|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Positive Participants|Hazard Ratio (HR)|0.71||||0.0496|TWO_SIDED|95.0|0.5|1.0||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.00|0.50|0.0496
71878641|NCT01704287|143277048|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|1.07||||0.6043|TWO_SIDED|95.0|0.65|1.76||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.76|0.65|0.6043
71878642|NCT01704287|143277048|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.62||||0.0335|TWO_SIDED|95.0|0.37|1.04||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.04|0.37|0.0335
71878643|NCT01704287|143277048|SUPERIORITY_OR_OTHER_LEGACY|PD-L1 Negative Participants|Hazard Ratio (HR)|0.71||||0.1504|TWO_SIDED|95.0|0.44|1.13||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels \[≥110% ULN\]); \& BRAF mutational status (mutant vs. wild-type)||1.13|0.44|0.1504
71878644|NCT00938717|143277055|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.65|||<|0.0001|TWO_SIDED|95.0|2.44|8.84||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||8.84|2.44|<0.0001
71878645|NCT00938717|143277056|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.0001|TWO_SIDED|95.0|2.5|7.03||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||7.03|2.50|<0.0001
71878646|NCT00938717|143277057|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.91|3.6||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.||3.60|1.91|<0.0001
71878647|NCT00938717|143277058|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.16|||<|0.0001|TWO_SIDED|95.0|2.22|4.49||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."||4.49|2.22|<0.0001
71878648|NCT01462435|143277077|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|446.946|STANDARD_ERROR_OF_MEAN|122.2935|<|0.001|TWO_SIDED|95.0|206.567|687.324|||ANCOVA|||||687.324|206.567|<0.001
71878649|NCT01462435|143277077|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|316.145|STANDARD_ERROR_OF_MEAN|121.5971||0.01|TWO_SIDED|95.0|77.136|555.155|||ANCOVA|||||555.155|77.136|0.010
71878650|NCT01462435|143277077|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|313.119|STANDARD_ERROR_OF_MEAN|122.5676||0.011|TWO_SIDED|95.0|72.202|554.037|||ANCOVA|||||554.037|72.202|0.011
71878651|NCT01462435|143277078|SUPERIORITY_OR_OTHER|||||||0.043||95.0|||||t-test, 2 sided|||||||0.043
71878652|NCT01462435|143277078|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||t-test, 2 sided|||||||0.109
71878653|NCT01462435|143277078|SUPERIORITY_OR_OTHER|||||||0.183||95.0|||||t-test, 2 sided|||||||0.183
71878654|NCT01462435|143277079|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
71878655|NCT01462435|143277079|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||t-test, 2 sided|||||||0.029
71878656|NCT01462435|143277079|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||t-test, 2 sided|||||||0.050
71878657|NCT01462435|143277080|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71878658|NCT01462435|143277080|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71878659|NCT01462435|143277080|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71878660|NCT01462435|143277081|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||t-test, 2 sided|||||||0.009
71878661|NCT01462435|143277081|SUPERIORITY_OR_OTHER|||||||0.091||95.0|||||t-test, 2 sided|||||||0.091
71878662|NCT01462435|143277081|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||t-test, 2 sided|||||||0.053
71878663|NCT01462435|143277082|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||t-test, 2 sided|||||||0.002
71878664|NCT01462435|143277082|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||t-test, 2 sided|||||||0.026
71878665|NCT01462435|143277082|SUPERIORITY_OR_OTHER|||||||0.017||95.0|||||t-test, 2 sided|||||||0.017
71878666|NCT01462435|143277083|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71878667|NCT01462435|143277083|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
71685832|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1214|TWO_SIDED|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||1.00|0.89|0.1214
71685833|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.9||||0.0043|TWO_SIDED|90.0|0.84|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.95|0.84|0.0043
71685834|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.2615|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||1.02|0.89|0.2615
71685835|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.1331|TWO_SIDED|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.01|0.88|0.1331
71685836|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.85|||<|0.0001|TWO_SIDED|90.0|0.81|0.89|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.89|0.81|<.0001
71685837|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0001|TWO_SIDED|90.0|0.83|0.93|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||0.93|0.83|0.0001
71685838|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.83|||<|0.0001|TWO_SIDED|90.0|0.79|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.88|0.79|<.0001
71685839|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.86||||0.0002|TWO_SIDED|90.0|0.81|0.92|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.92|0.81|0.0002
71685840|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.82|||<|0.0001|TWO_SIDED|90.0|0.77|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.88|0.77|<.0001
71685841|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.84||||0.0002|TWO_SIDED|90.0|0.78|0.9|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.90|0.78|0.0002
71878668|NCT01462435|143277083|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|||||||0.004
71878669|NCT01462435|143277084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71878670|NCT01462435|143277084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71878671|NCT01462435|143277084|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71878672|NCT02248259|143277093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.6|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.522|128.376|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.376|100.522|
71878673|NCT02248259|143277093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.98|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.839|99.452|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.452|77.839|
71878674|NCT02248259|143277093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.21|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.636|94.021|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||94.021|84.636|
71878675|NCT02248259|143277093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.89|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.592|97.396|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis of CD 13896||97.396|88.592|
71878676|NCT02248259|143277093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.796|103.584|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.584|95.796|
71878677|NCT02248259|143277093|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.37|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.783|110.278|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.278|98.783|
71878678|NCT02248259|143277094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|93.26|STANDARD_ERROR_OF_MEAN|1.086|||TWO_SIDED|90.0|80.377|108.217|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||108.217|80.377|
71878679|NCT02248259|143277094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|76.65|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|60.482|97.141|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||97.141|60.482|
71878680|NCT02248259|143277094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|78.71|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|67.304|92.052|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||92.052|67.304|
71878681|NCT02248259|143277094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|95.29|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|81.092|111.964|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||111.964|81.092|
71878682|NCT02248259|143277094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|86.79|STANDARD_ERROR_OF_MEAN|1.041|||TWO_SIDED|90.0|80.731|93.309|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||93.309|80.731|
71919105|NCT02442765|143360273|SUPERIORITY||MMRM weighted z-statistic|-0.39|||=|0.695|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.695
71919106|NCT02442765|143360273|SUPERIORITY||MMRM weighted z-statistic|-0.12|||=|0.904|TWO_SIDED|||||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, Baseline (BL), BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|ANCOVA|||||||=0.904
71919107|NCT02442765|143360274|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.247|TWO_SIDED|95.0|-3.2|0.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.8|-3.2|=0.247
71878683|NCT02248259|143277094|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|107.45|STANDARD_ERROR_OF_MEAN|1.091|||TWO_SIDED|90.0|91.764|125.812|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||125.812|91.764|
71878684|NCT02248259|143277095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|113.61|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|100.505|128.427|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for BI 409306||128.427|100.505|
71878685|NCT02248259|143277095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|87.91|STANDARD_ERROR_OF_MEAN|1.07|||TWO_SIDED|90.0|77.763|99.37|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for BI 409306||99.370|77.763|
71878686|NCT02248259|143277095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|89.05|STANDARD_ERROR_OF_MEAN|1.029|||TWO_SIDED|90.0|84.478|93.859|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 13896||93.859|84.478|
71919108|NCT02442765|143360274|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.721|TWO_SIDED|95.0|-2.3|1.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.6|-2.3|=0.721
71919109|NCT02442765|143360274|SUPERIORITY||Least Squares Mean Difference|-1.2|||=|0.419|TWO_SIDED|95.0|-4.3|1.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.8|-4.3|=0.419
71919110|NCT02442765|143360274|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.534|TWO_SIDED|95.0|-2.0|3.9||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||3.9|-2.0|=0.534
71919111|NCT02442765|143360274|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
71919112|NCT02442765|143360274|SUPERIORITY||MMRM weighted z-statistic|0.19|||=|0.851|TWO_SIDED||||||ANCOVA|||||||=0.851
71685842|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.228|TWO_SIDED|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.02|0.89|0.2280
71685843|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.009|TWO_SIDED|90.0|0.89|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7||0.97|0.89|0.0090
71685844|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.6237|TWO_SIDED|90.0|0.93|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14||1.04|0.93|0.6237
71685845|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.008|TWO_SIDED|90.0|0.87|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28||0.97|0.87|0.0080
71685846|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0105|TWO_SIDED|90.0|0.86|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42||0.97|0.86|0.0105
71685847|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0217|TWO_SIDED|90.0|0.86|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56||0.98|0.86|0.0217
71685848|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.88||||0.0031|TWO_SIDED|90.0|0.82|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84||0.94|0.82|0.0031
71685849|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.01||||0.774|TWO_SIDED|90.0|0.95|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)||1.07|0.95|0.7740
71685850|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.95||||0.1783|TWO_SIDED|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.01|0.89|0.1783
71685851|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.91||||0.0219|TWO_SIDED|90.0|0.84|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||0.97|0.84|0.0219
71685852|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.92||||0.0719|TWO_SIDED|90.0|0.85|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||0.99|0.85|0.0719
71919113|NCT02442765|143360275|SUPERIORITY||Least Squares Mean Difference|-0.6|||=|0.146|TWO_SIDED|95.0|-1.4|0.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.2|-1.4|=0.146
71919114|NCT02442765|143360275|SUPERIORITY||Least Squares Mean Difference|0.3|||=|0.399|TWO_SIDED|95.0|-0.4|1.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||1.1|-0.4|=0.399
71685853|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.93||||0.2199|TWO_SIDED|90.0|0.85|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.02|0.85|0.2199
71685854|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.96||||0.4928|TWO_SIDED|90.0|0.87|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.06|0.87|0.4928
71685855|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.94||||0.3419|TWO_SIDED|90.0|0.85|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.05|0.85|0.3419
71685856|NCT02913105|142889730|OTHER|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.98||||0.7281|TWO_SIDED|90.0|0.88|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.09|0.88|0.7281
71685857|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.318|TWO_SIDED|90.0|0.97|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.12|0.97|0.3180
71685858|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.6576|TWO_SIDED|90.0|0.95|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.10|0.95|0.6576
71685859|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|0.97||||0.6035|TWO_SIDED|90.0|0.9|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.06|0.90|0.6035
71685860|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.3261|TWO_SIDED|90.0|0.96|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.17|0.96|0.3261
71685861|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.04||||0.5246|TWO_SIDED|90.0|0.94|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.15|0.94|0.5246
71878687|NCT02248259|143277095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|92.48|STANDARD_ERROR_OF_MEAN|1.026|||TWO_SIDED|90.0|88.278|96.889|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 13896||96.889|88.278|
71878688|NCT02248259|143277095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|99.61|STANDARD_ERROR_OF_MEAN|1.022|||TWO_SIDED|90.0|95.791|103.583|||||Ratio calculated as extensive metabolisers test treatment divided by extensive metabolisers: ref. treatment|Analysis for CD 14084||103.583|95.791|
71878689|NCT02248259|143277095|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence range was 80% to 125%|Geometric mean ratio (%)|104.44|STANDARD_ERROR_OF_MEAN|1.031|||TWO_SIDED|90.0|98.861|110.336|||||Ratio calculated as poor metabolisers test treatment divided by poor metabolisers: ref. treatment|Analysis for CD 14084||110.336|98.861|
71919115|NCT02442765|143360275|SUPERIORITY||Least Squares Mean Difference|0.7|||=|0.283|TWO_SIDED|95.0|-0.6|2.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.0|-0.6|=0.283
71919116|NCT02442765|143360275|SUPERIORITY||Least Squares Mean Difference|1.2|||=|0.065|TWO_SIDED|95.0|-0.1|2.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.5|-0.1|=0.065
71919117|NCT02442765|143360275|SUPERIORITY||MMRM weighted z-statistic|-0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
71878690|NCT02573870|143277098|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|p-values were not presented as non-inferiority was assessed by confidence interval (CI).|Mean Difference (Final Values)|-2.245|||||TWO_SIDED|95.0|-6.153|1.663|||||Treatment difference is calculated as active minus placebo and the non-inferiority bound was 10 bpm for Day 42|||1.663|-6.153|
71878691|NCT01206062|143277101|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75|||<|0.001|TWO_SIDED|95.0|0.64|0.89|||Regression, Cox|||||0.89|0.64|<0.001
71878692|NCT01206062|143277102|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.003|TWO_SIDED|95.0|0.6|0.9|||Regression, Cox|||||0.90|0.60|0.003
71878693|NCT01206062|143277103|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.58|TWO_SIDED|95.0|0.34|1.83|||Regression, Cox|||||1.83|0.34|0.58
71878694|NCT01206062|143277105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.83||||0.1|TWO_SIDED|95.0|0.67|1.04|||Regression, Cox|||||1.04|0.67|.10
71878695|NCT01825057|143277161|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0009|TWO_SIDED|||||adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - Do One|||||0.0009
71878696|NCT01825057|143277161|SUPERIORITY||Median Difference (Final Values)|19.7|||<|0.0001|TWO_SIDED|||||Adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner Method|Kruskal-Wallis|degrees of freedom = 2|mean difference = Order One - See One|||||<0.0001
71878697|NCT01825057|143277161|SUPERIORITY||Mean Difference (Final Values)|2.178||||0.4983|TWO_SIDED||||||Kruskal-Wallis|degrees of freedom = 2|mean difference = Do One - See One|||||0.4983
71878698|NCT01825057|143277162|SUPERIORITY||Mean Difference (Final Values)|0.62||||0.0217|TWO_SIDED|||||Adjusted for multiple comparisons using the Dwass, Steel, Critchlow-Fligner Method.|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0217
71919118|NCT02442765|143360275|SUPERIORITY||MMRM weighted z-statistic|1.94|||=|0.052|TWO_SIDED||||||ANCOVA|||||||=0.052
71919119|NCT02442765|143360276|SUPERIORITY||Least Squares Mean Difference|-0.7|||=|0.53|TWO_SIDED|95.0|-2.7|1.4|||ANCOVA|||||1.4|-2.7|=0.530
71919120|NCT02442765|143360276|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.326|TWO_SIDED|95.0|-3.1|1.0|||ANCOVA|||||1.0|-3.1|=0.326
71919121|NCT02442765|143360276|SUPERIORITY||Least Squares Mean Difference|2.5|||=|0.135|TWO_SIDED|95.0|-0.8|5.9|||ANCOVA|||||5.9|-0.8|=0.135
71919122|NCT02442765|143360276|SUPERIORITY||Least Squares Mean Difference|0.2|||=|0.895|TWO_SIDED|95.0|-3.1|3.5|||ANCOVA|||||3.5|-3.1|=0.895
71919123|NCT02442765|143360276|SUPERIORITY||SPCD OLS weighted Z-statistic|0.67|||=|0.502|TWO_SIDED||||||ANCOVA|||||||=0.502
71919124|NCT02442765|143360276|SUPERIORITY||SPCD OLS weighted Z-statistic|-0.58|||=|0.564|TWO_SIDED||||||ANCOVA|||||||=0.564
71919125|NCT02442765|143360277|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.061|TWO_SIDED|95.0|-1.6|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.0|-1.6|=0.061
71878699|NCT01825057|143277162|SUPERIORITY|mean difference is Order One - See One|Mean Difference (Final Values)|1.22||||0.0126|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis|||||||0.0126
71878700|NCT01825057|143277162|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.4231|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference is Do One - See One|||||0.4231
71878701|NCT01825057|143277163|SUPERIORITY||Mean Difference (Final Values)|0.44||||0.0091|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.0091
71878702|NCT01825057|143277163|SUPERIORITY||Mean Difference (Final Values)|1.04||||0.0196|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0196
71878703|NCT01825057|143277163|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.2832|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.2832
71878704|NCT01825057|143277164|SUPERIORITY||Mean Difference (Final Values)|0.43||||0.1566|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||0.1566
71878705|NCT01825057|143277164|SUPERIORITY||Mean Difference (Final Values)|0.88||||0.0982|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Order One - See One|||||0.0982
71685862|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7519|TWO_SIDED|90.0|0.92|1.14|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.14|0.92|0.7519
71685863|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.0||||0.9577|TWO_SIDED|90.0|0.89|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.12|0.89|0.9577
71685864|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.1||||0.016|TWO_SIDED|90.0|1.03|1.18|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7||1.18|1.03|0.0160
71685865|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.13||||0.0052|TWO_SIDED|90.0|1.05|1.21|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14||1.21|1.05|0.0052
71685866|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.06||||0.1822|TWO_SIDED|90.0|0.99|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28||1.15|0.99|0.1822
71685867|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.14||||0.0159|TWO_SIDED|90.0|1.04|1.24|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42||1.24|1.04|0.0159
71685868|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1524|TWO_SIDED|90.0|0.99|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56||1.19|0.99|0.1524
71685869|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.08||||0.1749|TWO_SIDED|90.0|0.98|1.2|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84||1.20|0.98|0.1749
71685870|NCT02913105|142889730|SUPERIORITY|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Geometric Mean Ratios|1.02||||0.7503|TWO_SIDED|90.0|0.92|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)||1.13|0.92|0.7503
71685871|NCT02913105|142889731|OTHER|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|5.52||0.2073|TWO_SIDED|90.0|-2.161|16.178|||ANCOVA|||||16.178|-2.161|0.2073
71685872|NCT02913105|142889731|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|7.23|STANDARD_ERROR_OF_MEAN|5.62||0.2014|TWO_SIDED|90.0|-2.106|16.563|||ANCOVA|||||16.563|-2.106|0.2014
71685873|NCT02913105|142889731|SUPERIORITY|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian\<30 and Non-Asian\<35) and high BMI (Asian \>=30 and Non-Asian\>=35).|Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|4.93||0.9645|TWO_SIDED|90.0|-7.974|8.414|||ANCOVA|||||8.414|-7.974|0.9645
71878706|NCT01825057|143277164|SUPERIORITY||Mean Difference (Final Values)|0.45||||0.6631|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.6631
71878707|NCT01825057|143277165|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.1327|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||Mean difference = Order One - Do One|||||.1327
71878708|NCT01825057|143277165|SUPERIORITY||Mean Difference (Final Values)|0.57||||0.4097|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||||mean difference = Order One - See One|||0.4097
71685874|NCT01153009|142889755|SUPERIORITY_OR_OTHER||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|1.21||0.224|TWO_SIDED|95.0|-3.86|0.91||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.||0.91|-3.86|0.224
71685875|NCT01153009|142889755|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|1.21||0.023|TWO_SIDED|95.0|-5.12|-0.38||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.025, hierarchical testing continues for this dose.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-0.38|-5.12|0.023
71919126|NCT02442765|143360277|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.4|TWO_SIDED|95.0|-1.1|0.5||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.5|-1.1|=0.400
71919127|NCT02442765|143360277|SUPERIORITY||Least Squares Mean Difference|-1.1|||=|0.115|TWO_SIDED|95.0|-2.4|0.3||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.3|-2.4|=0.115
71919128|NCT02442765|143360277|SUPERIORITY||Least Squares Mean Difference|-0.8|||=|0.264|TWO_SIDED|95.0|-2.1|0.6||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||0.6|-2.1|=0.264
71919129|NCT02442765|143360277|SUPERIORITY||MMRM weighted z-statistic|-2.44|||=|0.015|TWO_SIDED||||||ANCOVA|||||||=0.015
71919130|NCT02442765|143360277|SUPERIORITY||MMRM weighted z-statistic|-1.4|||=|0.163|TWO_SIDED||||||ANCOVA|||||||=0.163
71919131|NCT02442765|143360278|SUPERIORITY||Least Squares Mean Difference|-3.9|||=|0.05|TWO_SIDED|95.0|-7.8|0.0||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||-0.0|-7.8|=0.050
71685876|NCT01153009|142889755|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.21|<|0.001|TWO_SIDED|95.0|-6.46|-1.69|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||-1.69|-6.46|<0.001
71919132|NCT02442765|143360278|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.412|TWO_SIDED|95.0|-5.4|2.2||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||2.2|-5.4|=0.412
71919133|NCT02442765|143360278|SUPERIORITY||Least Squares Mean Difference|-1.0|||=|0.775|TWO_SIDED|95.0|-7.8|5.8||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||5.8|-7.8|=0.775
71919134|NCT02442765|143360278|SUPERIORITY||Least Squares Mean Difference|3.3|||=|0.333|TWO_SIDED|95.0|-3.5|10.1||"MMRMs include fixed effects of treatment, visit, treatment-by-visit, BL, BL-by-visit, and in the Stage 1 model, BL NPI AA, risk assessment for falls, BL concomitant antipsychotic medication use.~Unstructured variance-covariance was used."|MMRM|||||10.1|-3.5|=0.333
71919135|NCT02442765|143360278|SUPERIORITY||MMRM weighted z-statistic|-1.5|||=|0.133|TWO_SIDED||||||ANCOVA|||||||=0.133
71919136|NCT02442765|143360278|SUPERIORITY||MMRM weighted z-statistic|0.22|||=|0.829|TWO_SIDED||||||ANCOVA|||||||=0.829
71919137|NCT02442765|143360279|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.118|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|||||0.0|-0.4|=0.118
71919138|NCT02442765|143360279|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.191|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.191
71919139|NCT02442765|143360279|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.225|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.225
71919140|NCT02442765|143360279|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.227|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.227
71919141|NCT02442765|143360279|SUPERIORITY||SPCD OLS weighted z-statistic|-1.97|||=|0.049|TWO_SIDED||||||ANCOVA|||||||=0.049
71919142|NCT02442765|143360279|SUPERIORITY||SPCD OLS weighted z-statistic|-1.78|||=|0.075|TWO_SIDED||||||ANCOVA|||||||=0.075
71919143|NCT02442765|143360280|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.364|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|=0.364
71919144|NCT02442765|143360280|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.427|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||||0.2|-0.4|=0.427
71919145|NCT02442765|143360280|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.098|TWO_SIDED|95.0|-0.9|0.1|||ANCOVA|||||0.1|-0.9|=0.098
71919146|NCT02442765|143360280|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.168|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||||0.1|-0.8|=0.168
71919147|NCT02442765|143360280|SUPERIORITY||SPCD OLS weighted z-statistic|-1.86|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
71919148|NCT02442765|143360280|SUPERIORITY||SPCD OLS weighted z-statistic|-1.57|||=|0.115|TWO_SIDED||||||ANCOVA|||||||=0.115
71919149|NCT02442765|143360281|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.014|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||||-0.1|-0.6|=0.014
71919150|NCT02442765|143360281|SUPERIORITY||Least Squares Mean Difference|-0.2|||=|0.111|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|=0.111
71919151|NCT02442765|143360281|SUPERIORITY||Least Squares Mean Difference|-0.5|||=|0.062|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||||0.0|-1.1|=0.062
71919152|NCT02442765|143360281|SUPERIORITY||Least Squares Mean Difference|-0.3|||=|0.305|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|=0.305
71919153|NCT02442765|143360281|SUPERIORITY||SPCD OLS weighted z-statistic|-3.01|||=|0.003|TWO_SIDED||||||ANCOVA|||||||=0.003
71919154|NCT02442765|143360281|SUPERIORITY||SPCD OLS weighted z-statistic|-1.79|||=|0.073|TWO_SIDED||||||ANCOVA|||||||=0.073
71685877|NCT01153009|142889756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.249||||0.348|TWO_SIDED|95.0|0.786|1.984|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.984|0.786|0.348
71685878|NCT01153009|142889756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.257||||0.332|TWO_SIDED|95.0|0.792|1.994||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.792|0.332
71878709|NCT01825057|143277165|SUPERIORITY||Mean Difference (Final Values)|0.33||||0.8779|TWO_SIDED|||||p-value adjusted for multiple comparisons using Dwass, Steel, Critchlow-Fligner method|Kruskal-Wallis||mean difference = Do One - See One|||||0.8779
71878710|NCT04746833|143277176|EQUIVALENCE|mean of Summit will be equal to mean of control||||||0.91|||||||t-test, 2 sided|||||||.91
71878711|NCT04746833|143277177|OTHER|||||||||||||||||descriptive statistic of system use|simple descriptive findings for evaluation of feasibility of the Sumit app|||
71878712|NCT04746833|143277178|EQUIVALENCE|standard null hypothesis of no difference between groups||||||0.5|||||||t-test, 2 sided|||||||.50
71878713|NCT00290290|143277179|SUPERIORITY_OR_OTHER||Relative Risk|0.59||||0.004|TWO_SIDED|95.0|0.41|0.85|||Log Rank|||The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.||0.85|0.41|0.004
71878714|NCT00003895|143277183|SUPERIORITY_OR_OTHER||||||<|0.001||||||Post versus Pre-treatment % g209-2M-specific t-cells|t-test, 2 sided|||||||<.001
71878715|NCT00003895|143277183|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Post versus Pre-Treatment %g209-2M-specific T-cells|t-test, 2 sided|||||||<.0001
71878716|NCT00003895|143277183|SUPERIORITY_OR_OTHER|||||||0.59||||||Arm A Versus Arm B|t-test, 2 sided|||||||0.59
71878717|NCT03634397|143277184|OTHER||Mean Difference (Final Values)|5.73|||<|0.05|TWO_SIDED|95.0|2.31|9.14||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear||The delta values of the outcome from baseline 2 to post-treatment 1 were directly modeled using linear regression with adjustment for age, female sex, and the hemisphere affected by the stroke.|||9.14|2.31|<.05
71878718|NCT03634397|143277186|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Mean Difference (Final Values)|0.83|||<|0.05|TWO_SIDED|95.0|-2.58|4.24||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.||||4.24|-2.58|<.05
71878719|NCT03634397|143277187|OTHER|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Median Difference (Final Values)|1.12|||<|0.05|TWO_SIDED|95.0|-2.29|4.53||P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|Regression, Linear|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|P-values include adjustment for age, female sex, and hemisphere of brain affected by stroke.|||4.53|-2.29|<.05
71878720|NCT02752035|143277199|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.523|TWO_SIDED|95.0|0.57|1.329|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.329|0.570|0.523
71878721|NCT02752035|143277200|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.787|TWO_SIDED|95.0|0.635|1.393|||Log Rank||Based on Cox proportional hazards model.|Stratification factors were age group per IRT, risk groups and baseline FLT3 mutation status, with potential of strata pooling.||1.393|0.635|0.787
71878722|NCT02752035|143277202|SUPERIORITY||Treatment Difference|8.2||||0.249|TWO_SIDED|95.0|-6.5|23.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||23.0|-6.5|0.249
71878723|NCT02752035|143277203|SUPERIORITY||Treatment Difference|33.3|||<|0.001|TWO_SIDED|95.0|16.6|50.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||50.0|16.6|<0.001
71878724|NCT02752035|143277204|SUPERIORITY||Treatment Difference|8.5||||0.049|TWO_SIDED|95.0|-0.1|17.1||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||17.1|-0.1|0.049
71878725|NCT02752035|143277205|SUPERIORITY||Treatment Difference|16.7||||0.032|TWO_SIDED|95.0|1.1|32.4||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||32.4|1.1|0.032
71878726|NCT02752035|143277206|SUPERIORITY||Treatment Difference|-9.0||||0.34|TWO_SIDED|95.0|-29.8|11.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||11.0|-29.8|0.340
71878727|NCT02752035|143277207|SUPERIORITY||Treatment Difference|50.0||||0.221|TWO_SIDED|95.0|-61.0|100.0||Based on stratified Cochran-Mantel-Haenszel test. Stratification factor was age group per interactive response technology.|Cochran-Mantel-Haenszel|||||100.0|-61.0|0.221
71878728|NCT02752035|143277208|SUPERIORITY||Hazard Ratio (HR)|0.844||||0.592|TWO_SIDED|95.0|0.451|1.58|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|||1.580|0.451|0.592
71878729|NCT02752035|143277209|SUPERIORITY||Hazard Ratio (HR)|0.573||||0.3|TWO_SIDED|95.0|0.198|1.658|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR/CRh.||1.658|0.198|0.300
71878730|NCT02752035|143277209|SUPERIORITY||Hazard Ratio (HR)|0.411||||0.171|TWO_SIDED|95.0|0.113|1.504|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CR.||1.504|0.113|0.171
71878731|NCT02752035|143277209|SUPERIORITY||Hazard Ratio (HR)|0.691||||0.383|TWO_SIDED|95.0|0.295|1.62|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRc||1.620|0.295|0.383
71878732|NCT02752035|143277209|SUPERIORITY||Hazard Ratio (HR)|999.0||||0.998|TWO_SIDED|95.0|0.001||Upper limit of 95% confidence interval was not estimable due to insufficient number of participants.||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of CRh.|||0.001|0.998
71685879|NCT01153009|142889756|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.991||||0.004|TWO_SIDED|95.0|1.25|3.171|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.171|1.250|0.004
71685880|NCT01153009|142889757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.14||0.4|TWO_SIDED|95.0|-0.39|0.16|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.16|-0.39|0.400
71685881|NCT01153009|142889757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.139||0.177|TWO_SIDED|95.0|-0.46|0.08|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||0.08|-0.46|0.177
71685882|NCT01153009|142889757|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.139||0.014|TWO_SIDED|95.0|-0.61|-0.07|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.||||-0.07|-0.61|0.014
71685883|NCT01153009|142889758|SUPERIORITY_OR_OTHER||LS Mean Difference|0.93|STANDARD_ERROR_OF_MEAN|2.286||0.684|TWO_SIDED|95.0|-3.58|5.45|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||5.45|-3.58|0.684
71685884|NCT01153009|142889758|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|2.419||0.797|TWO_SIDED|95.0|-5.4|4.15|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||4.15|-5.40|0.797
71685885|NCT01153009|142889758|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|2.278||0.078|TWO_SIDED|95.0|-8.54|0.45|||Mixed model for repeated mesurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||||0.45|-8.54|0.078
71685886|NCT01153009|142889759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.053||||0.845|TWO_SIDED|95.0|0.625|1.775|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.775|0.625|0.845
71685887|NCT01153009|142889759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.503|TWO_SIDED|95.0|0.713|1.994|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.994|0.713|0.503
71685888|NCT01153009|142889759|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.098||||0.728|TWO_SIDED|95.0|0.648|1.86|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||1.860|0.648|0.728
71685889|NCT01153009|142889760|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|1.111||0.962|TWO_SIDED|95.0|-2.24|2.13|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||2.13|-2.24|0.962
71685890|NCT01153009|142889760|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.88|STANDARD_ERROR_OF_MEAN|1.103||0.427|TWO_SIDED|95.0|-3.05|1.29|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||1.29|-3.05|0.427
71878733|NCT02752035|143277209|SUPERIORITY||Hazard Ratio (HR)|0.628||||0.174|TWO_SIDED|95.0|0.321|1.229|||Log Rank||Based on Cox proportional hazards model adjusting age group per IRT.|Analysis reported for duration of response.||1.229|0.321|0.174
71878734|NCT02752035|143277210|SUPERIORITY||Least square mean difference|0.5||||0.56|TWO_SIDED|95.0|-1.1|2.0|||ANCOVA|Using analysis of covariance including treatment, age group per IRT and baseline score as covariate.|Least square mean difference and P-value were calculated using AZA as reference.|||2.0|-1.1|0.560
71878735|NCT01846728|143277235|OTHER|||||||0.84||||||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|t-test, 2 sided|||||||0.84
71878736|NCT01846728|143277236|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
71685891|NCT01153009|142889760|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|1.123||0.078|TWO_SIDED|95.0|-4.19|0.22|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.||||0.22|-4.19|0.078
71878737|NCT01846728|143277237|OTHER|Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||||0.92|||||||t-test, 2 sided|||||||0.92
71685892|NCT00703326|142889776|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.88||||0.077|TWO_SIDED|95.0|0.75|1.01|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.01|0.75|0.077
71685893|NCT00703326|142889777|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.95||||0.487|TWO_SIDED|95.0|0.81|1.1||The gate-keeping strategy used to control overall type 1 error 0.05 (2-sided) or 0.025 (1-sided) to analyze progression-free survival (PFS) and OS. At final PFS analysis only if primary PFS test was significant would analysis of OS be inferential.|Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.10|0.81|0.487
71685894|NCT00703326|142889778|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.85||||0.033|TWO_SIDED|95.0|0.73|0.99|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||0.99|0.73|0.033
71878738|NCT01846728|143277238|OTHER|||||||0.98|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.98
71878739|NCT01846728|143277239|OTHER|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||0.66
71685895|NCT00703326|142889779|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.33||||0.027|TWO_SIDED|95.0|1.03|1.71|||Stratified Cochran-Mantel-Haenszel(SCMH)|SCMH used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|Stratified odds ratio was calculated considering the IWRS stratification factors.|||1.71|1.03|0.027
71685896|NCT00703326|142889780|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.15|TWO_SIDED|95.0|0.67|1.06|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.|||1.06|0.67|0.150
71685897|NCT00703326|142889781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.539||||||P-value is for end of therapy. Analysis of covariance (ANCOVA) adjusted for baseline score was used to compare the 2 treatment arms.|ANCOVA|||||||0.539
71685898|NCT02242019|142889786|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71685899|NCT02242019|142889787|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71685900|NCT03214679|142889815|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<.001
71685901|NCT01601067|142889820|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||.002
71685902|NCT01601067|142889821|SUPERIORITY|||||||0.91||||||heavy drinking days|Mixed Models Analysis|||||||.91
71685903|NCT02771860|142889832|SUPERIORITY||Mean Difference (Final Values)|8.9||||0.024|TWO_SIDED|95.0|1.0|16.9|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||16.9|1.0|0.024
71878740|NCT02161575|143277240|SUPERIORITY||Median Difference (Final Values)|-30.75|||<|0.0001|TWO_SIDED|95.0|-59.5|-20.5|||Wilcoxon (Mann-Whitney)|Confidence Interval for the Median Change form Baseline||The null hypothesis was that the change in CSRT from baseline to Day 90 was zero||-20.50|-59.50|<0.0001
71878741|NCT00496730|143277297|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71685904|NCT02771860|142889833|SUPERIORITY||Odds Ratio (OR)|0.23|||<|0.001|TWO_SIDED|95.0|0.11|0.5|||Regression, Logistic|||||0.50|0.11|<0.001
71685905|NCT02771860|142889834|SUPERIORITY||Mean Difference (Final Values)|14.3||||0.003|TWO_SIDED|95.0|4.6|24.0|||GEE|||Comparison between groups was done by Generalized Estimation Equations at joint level, accounting for within-patient clustering and adjusted for baseline unbalances. Missing values were imputed according to a predefined imputation model, including randomization group, baseline value and values at other time points available, presence of baseline inflammation, baseline number of affected joints.||24.0|4.6|0.003
71919155|NCT02442765|143360282|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.909|TWO_SIDED|95.0|-2.2|2.5|||ANCOVA|||||2.5|-2.2|=0.909
71685906|NCT02412878|142889849|SUPERIORITY||Odds Ratio (OR)|2.485|||<|0.0001|TWO_SIDED|95.0|1.716|3.598||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Cochran-Mantel-Haenszel|One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.|||3.598|1.716|< 0.0001
71685907|NCT02412878|142889849|SUPERIORITY||Odds Ratio (OR)|2.466|||<|0.0001|TWO_SIDED|95.0|1.707|3.563|||Fisher Exact||Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.|||3.563|1.707|<0.0001
71685908|NCT02412878|142889850|SUPERIORITY||Hazard Ratio (HR)|0.693||||0.0014|TWO_SIDED|95.0|0.544|0.883||Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.||0.883|0.544|0.0014
71685909|NCT02412878|142889850|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0033|TWO_SIDED|95.0|0.567|0.913|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||0.913|0.567|0.0033
71685910|NCT02412878|142889851|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.107|TWO_SIDED|95.0|0.563|1.138||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|||1.138|0.563|0.1070
71685911|NCT02412878|142889851|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.1326|TWO_SIDED|95.0|0.578|1.164|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.|||1.164|0.578|0.1326
71878742|NCT00496730|143277298|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71878743|NCT00496730|143277299|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71919156|NCT02442765|143360282|SUPERIORITY||Least Squares Mean Difference|1.4|||=|0.226|TWO_SIDED|95.0|-0.9|3.8|||ANCOVA|||||3.8|-0.9|=0.226
71919157|NCT02442765|143360282|SUPERIORITY||Least Squares Mean Difference|2.1|||=|0.405|TWO_SIDED|95.0|-2.9|7.1|||ANCOVA|||||7.1|-2.9|=0.405
71685912|NCT05025332|142889923|OTHER|||||||0.0039|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots and histograms/bar charts were created at the EOT visit with plots for all participants.||||.0039
71685913|NCT05025332|142889924|OTHER|||||||0.0234|||||||Wilcoxon Signed rank|null median = 4, not 0||Descriptive statistics were used to summarize the data. For total scores, waterfall plots, and histograms were created at the EOT visit with plots for all participants.||||0.0234
71685914|NCT05025332|142889925|OTHER|Change from baseline||||||0.0313|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0313
71685915|NCT05025332|142889926|OTHER|Change from baseline||||||0.0039|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.0039
71685916|NCT05025332|142889927|OTHER|change from baseline||||||0.1934|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.1934
71685917|NCT05025332|142889928|OTHER|Change from baseline||||||0.748|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7480
71878744|NCT00427349|143277361|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||one sample binomial test|The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test||The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).||||<0.001
71685918|NCT05025332|142889929|OTHER|Change from baseline||||||0.3203|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3203
71685919|NCT05025332|142889930|OTHER|change from baseline||||||0.3574|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3574
71685920|NCT05025332|142889931|OTHER|Change from baseline||||||0.4131|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.4131
71878745|NCT05082376|143277373|OTHER||Adjusted Mean Difference|7.7|||<|0.0001|TWO_SIDED|95.0|6.6|8.8|||ANCOVA|Analysis of Covariance (ANCOVA) model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 2 hours post-treatment||8.8|6.6|<0.0001
71685921|NCT05025332|142889932|OTHER|change from baseline||||||0.9063|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.9063
71685922|NCT05025332|142889933|OTHER|Change from baseline||||||1|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||1.00
71685923|NCT05025332|142889934|OTHER|Change from baseline||||||0.7002|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7002
71685924|NCT05025332|142889935|OTHER|Change from baseline||||||0.375|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.3750
71878746|NCT05082376|143277373|OTHER||Adjusted Mean Difference|6.9|||<|0.0001|TWO_SIDED|95.0|5.8|7.9|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 4 hours post-treatment.||7.9|5.8|<0.0001
71878747|NCT05082376|143277373|OTHER||Adjusted Mean Difference|5.1|||<|0.0001|TWO_SIDED|95.0|4.0|6.2|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 6 hours post-treatment.||6.2|4.0|<0.0001
71685925|NCT05025332|142889936|OTHER|||||||0.7695|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.7695
71685926|NCT05025332|142889937|OTHER|||||||0.2402|||||||Wilcoxon Signed rank|||Efficacy endpoints were analyzed using a Wilcoxon signed rank test on the paired participant data from baseline to EOT (Visit 16), when applicable. Baseline values were based on the average non-missing values of visits 1, 2, and 3 for assessments collected at more than one visit during the Screening/Baseline period.||||0.2402
71685927|NCT01212159|142889938|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Comparison of mean reduction in LDL cholesterol between no monitor (control) and monitor (intervention) groups|t-test, 2 sided|||Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groups||||0.391
71685928|NCT01306214|142889941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|97.5|-0.61|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 10 mg - Adjusted mean of placebo.|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~Hypothesis test:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.27|-0.61|<0.0001
71685929|NCT01306214|142889941|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|97.5|-0.69|-0.35||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.35|-0.69|<0.0001
71685930|NCT01306214|142889942|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.83|STANDARD_ERROR_OF_MEAN|3.05||0.004|TWO_SIDED|97.5|-15.69|-1.97||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo"||-1.97|-15.69|0.004
71685931|NCT01306214|142889942|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.22|STANDARD_ERROR_OF_MEAN|3.05||0.0003|TWO_SIDED|97.5|-18.09|-4.36||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo.|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo"||-4.36|-18.09|0.0003
71685932|NCT01306214|142889943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.39|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.54|-1.24||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo"||-1.24|-3.54|<0.0001
71758600|NCT00836693|143019577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|95.0|2.2|5.5||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||5.5|2.2|<0.001
71878748|NCT05082376|143277373|OTHER||Adjusted Mean Difference|4.7|||<|0.0001|TWO_SIDED|95.0|3.6|5.8|||ANCOVA|ANCOVA model with treatment, timepoint, treatment\*timepoint (interaction) and subject as terms; Baseline value as covariate.||Pairwise comparison between Treated and Untreated sites 8 hours post-treatment.||5.8|3.6|<0.0001
71878749|NCT03023930|143277375|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|proc logistic||||||<0.001
71878750|NCT03023930|143277376|SUPERIORITY|||||||0.011|||||||Regression, Logistic|proc logistic||||||0.011
71878751|NCT00290186|143277404|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.539||95.0|-1.5|3.3|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.3|-1.5|0.539
71878752|NCT00290186|143277405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.921|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.8|-1.6|0.921
71878753|NCT00290186|143277406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.945|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.945
71878754|NCT00290186|143277407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4||||0.342|TWO_SIDED|95.0|-5.1|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-5.1|0.342
71919158|NCT02442765|143360282|SUPERIORITY||Least Squares Mean Difference|-0.9|||=|0.714|TWO_SIDED|95.0|-5.8|4.0|||ANCOVA|||||4.0|-5.8|=0.714
71919159|NCT02442765|143360282|SUPERIORITY||SPCD OLS weighted z-statistic|0.75|||=|0.456|TWO_SIDED||||||ANCOVA|||||||=0.456
71685933|NCT01306214|142889943|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.48|STANDARD_ERROR_OF_MEAN|0.51|<|0.0001|TWO_SIDED|97.5|-3.63|-1.33||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|hypothesis test: H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo||-1.33|-3.63|<0.0001
71685934|NCT01306214|142889944|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|H0: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo \>0.3 Ha: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo ≤0.3||-0.13|-0.62|<0.0001
71685935|NCT01306214|142889944|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.11||0.0005|TWO_SIDED|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo"||-0.13|-0.62|0.0005
71685936|NCT01306214|142889944|NON_INFERIORITY_OR_EQUIVALENCE|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|H013: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo \>0.3 Ha13: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo ≤0.3||-0.22|-0.70|<0.0001
71685937|NCT01306214|142889944|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo"||-0.22|-0.70|<0.0001
71685938|NCT02081014|142889953|SUPERIORITY_OR_OTHER||Point estimate ratio|0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685939|NCT02081014|142889953|SUPERIORITY_OR_OTHER||Point estimate ratio|0.35|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685940|NCT02081014|142889953|SUPERIORITY_OR_OTHER||Point estimate ratio|0.57|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685941|NCT02081014|142889954|SUPERIORITY_OR_OTHER||Point estimate ratio|0.74|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685942|NCT02081014|142889954|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71878755|NCT00290186|143277408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.149|TWO_SIDED|95.0|-1.6|8.6|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||8.6|-1.6|0.149
71878756|NCT00290186|143277409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.685|TWO_SIDED|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||5.1|-3.0|0.685
71878757|NCT00290186|143277410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.584|TWO_SIDED|95.0|-2.4|3.0|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.0|-2.4|0.584
71878758|NCT00290186|143277411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.498|TWO_SIDED|95.0|-1.5|3.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||3.7|-1.5|0.498
71878759|NCT00290186|143277412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.945|TWO_SIDED|95.0|-2.3|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.2|-2.3|0.945
71919160|NCT02442765|143360282|SUPERIORITY||SPCD OLS weighted z-statistic|0.42|||=|0.678|TWO_SIDED||||||ANCOVA|||||||=0.678
71685943|NCT02081014|142889954|SUPERIORITY_OR_OTHER||Point estimate ratio|0.59|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71878760|NCT00290186|143277413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.932|TWO_SIDED|95.0|-2.1|2.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.4|-2.1|0.932
71878761|NCT00290186|143277414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3||||0.051|TWO_SIDED|95.0|-0.2|4.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||4.7|-0.2|0.051
71878762|NCT00290186|143277415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.648|TWO_SIDED|95.0|-4.0|2.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||2.8|-4.0|0.648
71685944|NCT02081014|142889955|SUPERIORITY_OR_OTHER||Point point ratio|0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71878763|NCT00290186|143277416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.473|TWO_SIDED|95.0|-4.7|1.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.||1.4|-4.7|0.473
71878764|NCT00290186|143277417|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|46.0||||0.157|TWO_SIDED|95.0|-22.0|114.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||114|-22|0.157
71878765|NCT00290186|143277418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.876|TWO_SIDED|95.0|-15.0|13.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.||13|-15|0.876
71878766|NCT00290186|143277419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-79.0||||0.167|TWO_SIDED|95.0|-198.0|41.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||41|-198|0.167
71878767|NCT00290186|143277420|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.0||||0.468|TWO_SIDED|95.0|-153.0|77.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.||77|-153|0.468
71878768|NCT00445224|143277426|SUPERIORITY_OR_OTHER|||||||0.041||95.0|||||ANOVA|||||||.041
71878769|NCT00445224|143277427|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||ANOVA|||Repeated measures ANOVA for group and time||||.049
71878770|NCT04391036|143277429|SUPERIORITY||||||>|0.99|||||||McNemar|||This was a paired analysis comparing successful insertion of the high and low Eudragit® Films. The McNemar's test statistic is based on the discordant pairs (number of participants with high successful, low unsuccessful versus low successful, high unsuccessful).||||>.99
71878771|NCT04391036|143277430|SUPERIORITY|||||||0.45||||||This was a paired analysis comparing difficulty of insertion of the high and low Eudragit® Films. The McNemar's test is based on discordant pairs (high was not difficult, low was difficult versus low was not difficult, high was difficult).|McNemar|||||||.45
71878772|NCT04391036|143277431|SUPERIORITY|||||||0.26|||||||Fisher Exact|This was an overall Fisher's exact test so the analysis applies to all categories.||||||.26
71878773|NCT04085523|143277432|SUPERIORITY||||||=|0.6004|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.6004
71878774|NCT04085523|143277432|SUPERIORITY||||||=|0.7022|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.7022
71878775|NCT04085523|143277432|SUPERIORITY||||||=|0.0849|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0849
71878776|NCT04085523|143277432|SUPERIORITY||||||=|0.0218|||||||ANCOVA|||ANCOVA model using treatment (dose groups and pooled placebo) and sex as fixed effects, and baseline age and baseline height SDS as the covariates.||||= 0.0218
71878777|NCT01877915|143277438|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.27|TWO_SIDED|95.0|0.84|1.05|||Log Rank|||Statistical Analysis 1||1.05|0.84|0.270
71878778|NCT01877915|143277444|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.951|TWO_SIDED|95.0|0.41|2.59|||Log Rank|||Statistical Analysis 1 (Fatal Bleeding)||2.59|0.41|0.951
71878779|NCT01877915|143277444|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.253|TWO_SIDED|95.0|0.33|1.34|||Log Rank|||Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)||1.34|0.33|0.253
71878780|NCT01357577|143277474|OTHER|||||||0.48||||||P-Value show above is for post-assessment time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.48
71878781|NCT01357577|143277474|OTHER|||||||0.12||||||The p-value shown above is for the 6-month time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.||||||.12
71878782|NCT01357577|143277474|OTHER|||||||0.65||||||The p-value shown above refers to the treatment main effect.|Mixed Models Analysis|||||||.65
71878783|NCT01357577|143277474|OTHER|||||||0.072||||||The p-value shown above refers to the timepoint main effect.|Mixed Models Analysis|||||||.072
71878784|NCT01357577|143277474|OTHER|||||||0.005|||||||Mixed Models Analysis|The p-value shown above refers to the interaction.||||||.0050
71878785|NCT01357577|143277474|OTHER|||||||0.12|||||||Mixed Models Analysis|The p-value shown above refers to the site main effect.||||||.12
71878786|NCT01357577|143277475|OTHER|mixed-effects linear regression model adjusted for study site and the baseline value of the dependent variable.||||||0.12||||||Post-treatment P-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (Alcohol Use) score.||||||.12
71878787|NCT01357577|143277475|OTHER|||||||0.84||||||6-month P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.84
71878788|NCT01357577|143277475|OTHER|||||||0.26||||||treatment main effect|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.26
71878789|NCT01357577|143277475|OTHER|||||||0.14||||||Timepoint main effect P-value|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.14
71878790|NCT01357577|143277475|OTHER|||||||0.29||||||interaction|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.29
71878791|NCT01357577|143277475|OTHER|||||||0.16||||||Site main effect P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.||||||.16
71919161|NCT02442765|143360283|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.278|TWO_SIDED|95.0|-1.1|0.3|||ANCOVA|||||0.3|-1.1|=0.278
71685945|NCT02081014|142889955|SUPERIORITY_OR_OTHER||Point estimate ratio|0.36|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685946|NCT02081014|142889955|SUPERIORITY_OR_OTHER||Point estimate ratio|0.53|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685947|NCT02081014|142889956|SUPERIORITY_OR_OTHER||Point estimate ratio|0.72|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685948|NCT02081014|142889956|SUPERIORITY_OR_OTHER||Point estimate ratio|0.44|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685949|NCT02081014|142889956|SUPERIORITY_OR_OTHER||Point estimate ratio|0.6|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685950|NCT02081014|142889957|SUPERIORITY_OR_OTHER||Point esimate ratio|0.98|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685951|NCT02081014|142889957|SUPERIORITY_OR_OTHER||Point estimate ratio|0.78|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71878792|NCT01357577|143277476|OTHER|||||||0.66||||||Post-treatment p-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (drug score).||||||.66
71878793|NCT01357577|143277476|OTHER|||||||0.53||||||6-month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.53
71919162|NCT02442765|143360283|SUPERIORITY||Least Squares Mean Difference|-0.1|||=|0.817|TWO_SIDED|95.0|-0.8|0.6|||ANCOVA|||||0.6|-0.8|=0.817
71685952|NCT02081014|142889957|SUPERIORITY_OR_OTHER||Point estimate ratio|0.79|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685953|NCT02081014|142889958|SUPERIORITY_OR_OTHER||Point estimate ratio|0.75|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685954|NCT02081014|142889958|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71919163|NCT02442765|143360283|SUPERIORITY||Least Squares Mean Difference|-0.4|||=|0.5|TWO_SIDED|95.0|-1.4|0.7|||ANCOVA|||||0.7|-1.4|=0.500
71919164|NCT02442765|143360283|SUPERIORITY||Least Squares Mean Difference|0.1|||=|0.795|TWO_SIDED|95.0|-0.9|1.2|||ANCOVA|||||1.2|-0.9|=0.795
71919165|NCT02442765|143360283|SUPERIORITY||SPCD OLS weighted z-statistic|-1.25|||=|0.213|TWO_SIDED||||||ANCOVA|||||||=0.213
71685955|NCT02081014|142889958|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685956|NCT02081014|142889959|SUPERIORITY_OR_OTHER||Point estimate ratio|0.82|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71919166|NCT02442765|143360283|SUPERIORITY||SPCD OLS weighted z-statistic|0.02|||=|0.985|TWO_SIDED||||||ANCOVA|||||||=0.985
71685957|NCT02081014|142889959|SUPERIORITY_OR_OTHER||Point estimate ratio|0.7|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685958|NCT02081014|142889959|SUPERIORITY_OR_OTHER||Point estimate ratio|0.85|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685959|NCT02081014|142889960|SUPERIORITY_OR_OTHER||Point estimate ratio|0.96|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685960|NCT02081014|142889960|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||<0.05
71685961|NCT02081014|142889960|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685962|NCT02081014|142889961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3693.2|STANDARD_ERROR_OF_MEAN|1520.1|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71685963|NCT02081014|142889961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7548.05|STANDARD_ERROR_OF_MEAN|1542.93||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||0.05
71685964|NCT02081014|142889961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3854.86|STANDARD_ERROR_OF_MEAN|1533.95|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71685965|NCT02081014|142889962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-144.9|STANDARD_ERROR_OF_MEAN|741.24|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
71685966|NCT02081014|142889962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1665.32|STANDARD_ERROR_OF_MEAN|696.97|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71685967|NCT02081014|142889962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1520.39|STANDARD_ERROR_OF_MEAN|700.92|>|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||>0.05
71685968|NCT02081014|142889963|SUPERIORITY_OR_OTHER||Point estimate ratio|0.41|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685969|NCT02081014|142889963|SUPERIORITY_OR_OTHER||Point estimate ratio|0.43|STANDARD_ERROR_OF_MEAN|0.34|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685970|NCT02081014|142889963|SUPERIORITY_OR_OTHER||Point estimate ratio|1.05|STANDARD_ERROR_OF_MEAN|0.81|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71878794|NCT01357577|143277476|OTHER|||||||0.86||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.86
71878795|NCT01357577|143277476|OTHER|||||||0.16||||||Timepoint main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.16
71878796|NCT01357577|143277476|OTHER|||||||0.47||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.47
71878797|NCT01357577|143277476|OTHER|||||||0.19||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.||||||.19
71878798|NCT01357577|143277477|OTHER|||||||0.18||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.18
71878799|NCT01357577|143277477|OTHER|||||||0.45||||||P-value at 6 months.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.45
71919167|NCT02442765|143360285|SUPERIORITY||Least Squares Mean Difference|-1.6|||=|0.018|TWO_SIDED|95.0|-2.9|-0.3|||ANCOVA|||||-0.3|-2.9|=0.018
71919168|NCT02442765|143360285|SUPERIORITY||Least Squares Mean Difference|0.0|||=|0.956|TWO_SIDED|95.0|-1.3|1.3|||ANCOVA|||||1.3|-1.3|=0.956
71685971|NCT02081014|142889964|SUPERIORITY_OR_OTHER||Point estimate ratio|0.23|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685972|NCT02081014|142889964|SUPERIORITY_OR_OTHER||Point estimate ratio|0.73|STANDARD_ERROR_OF_MEAN|0.88|>|0.05|TWO_SIDED||||||Mixed Models Analysis||Geometric means|||||>0.05
71685973|NCT02081014|142889964|SUPERIORITY_OR_OTHER||Point estimate ratio|3.23|STANDARD_ERROR_OF_MEAN|3.84|>|0.05|TWO_SIDED||||||Regression, Linear||Geometric means|||||>0.05
71685974|NCT01026818|142889987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.675|TWO_SIDED|95.0|0.63|2.06||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||2.06|0.63|0.675
71685975|NCT01026818|142889987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.704|TWO_SIDED|95.0|0.48|1.65||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.||1.65|0.48|0.704
71685976|NCT01026818|142889988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.016|TWO_SIDED|95.0|1.16|3.99||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||3.99|1.16|0.016
71685977|NCT01026818|142889988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.21|TWO_SIDED|95.0|0.79|2.85||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.85|0.79|0.210
71685978|NCT01026818|142889988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.273|TWO_SIDED|95.0|0.79|2.28||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.28|0.79|0.273
71878800|NCT01357577|143277477|OTHER|||||||0.73||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.73
71878801|NCT01357577|143277477|OTHER|||||||0.63||||||Timepoint main effect P-Value|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.63
71878802|NCT01357577|143277477|OTHER|||||||0.024||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.024
71685979|NCT01026818|142889988|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.259|TWO_SIDED|95.0|0.8|2.29||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||||2.29|0.80|0.259
71685980|NCT01026818|142889989|SUPERIORITY_OR_OTHER||LS Mean Differences|2.8|STANDARD_ERROR_OF_MEAN|1.03||0.007|TWO_SIDED|95.0|0.76|4.83||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.83|0.76|0.007
71878803|NCT01357577|143277477|OTHER|||||||0.15||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.||||||.15
71919169|NCT02442765|143360285|SUPERIORITY||Least Squares Mean Difference|1.1|||=|0.451|TWO_SIDED|95.0|-1.8|4.0|||ANCOVA|||||4.0|-1.8|=0.451
71685981|NCT01026818|142889989|SUPERIORITY_OR_OTHER||LS Mean differences|1.59|STANDARD_ERROR_OF_MEAN|1.02||0.118|TWO_SIDED|95.0|-0.41|3.6||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.60|-0.41|0.118
71685982|NCT01026818|142889989|SUPERIORITY_OR_OTHER||LS Mean Differences|0.26|STANDARD_ERROR_OF_MEAN|1.04||0.802|TWO_SIDED|95.0|-1.79|2.31||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.31|-1.79|0.802
71878804|NCT01357577|143277478|OTHER|||||||0.48||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.48
71878805|NCT01357577|143277478|OTHER|||||||0.2||||||6-Month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.20
71878806|NCT01357577|143277478|OTHER|||||||0.26||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.26
71878807|NCT01357577|143277478|OTHER|||||||0.71||||||Timepoint main effect.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.71
71878808|NCT01357577|143277478|OTHER|||||||0.56||||||Interaction main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.56
71878809|NCT01357577|143277478|OTHER|||||||0.51||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.||||||.51
71878810|NCT02414399|143277506|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.29||Alpha =0.045 (to account for .005 alpha spending at interim analysis)|Regression, Cox||azithromycin is the numerator and placebo is the denominator|Death or rehospitalization||1.29|.64|0.58
71878811|NCT02414399|143277506|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.49|TWO_SIDED|95.0|0.39|1.58|||Regression, Cox||Azithromycin-numerator and placebo-denominator|Death alone||1.58|0.39|0.49
71878812|NCT02414399|143277506|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.94|TWO_SIDED|95.0|0.7|1.47|||Regression, Cox||numerator-azithromycin denominator-placebo|Rehospitalization alone||1.47|.70|.94
71878813|NCT02414399|143277514|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.77|||||||Chi-squared|||M0||||0.77
71919170|NCT02442765|143360285|SUPERIORITY||Least Squares Mean Difference|0.9|||=|0.519|TWO_SIDED|95.0|-1.9|3.7|||ANCOVA|||||3.7|-1.9|=0.519
71685983|NCT01026818|142889989|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.22|STANDARD_ERROR_OF_MEAN|1.02||0.83|TWO_SIDED|95.0|-2.23|1.79||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.79|-2.23|0.830
71685984|NCT01026818|142889989|SUPERIORITY_OR_OTHER||LS Mean Differences|1.62|STANDARD_ERROR_OF_MEAN|1.22||0.184|TWO_SIDED|95.0|-0.78|4.03||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.03|-0.78|0.184
71685985|NCT01026818|142889989|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|STANDARD_ERROR_OF_MEAN|1.2||0.5|TWO_SIDED|95.0|-1.54|3.16||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.16|-1.54|0.500
71685986|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.37|STANDARD_ERROR_OF_MEAN|0.39||0.34||95.0|-0.39|1.14||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.14|-0.39|0.340
71685987|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.38||0.821|TWO_SIDED|95.0|-0.67|0.84||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.84|-0.67|0.821
71685988|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.46|STANDARD_ERROR_OF_MEAN|0.42||0.268|TWO_SIDED|95.0|-0.36|1.28||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.28|-0.36|0.268
71685989|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.0|STANDARD_ERROR_OF_MEAN|0.41||0.998|TWO_SIDED|95.0|-0.8|0.8||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.80|-0.80|0.998
71685990|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.42||0.728|TWO_SIDED|95.0|-0.68|0.97||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.97|-0.68|0.728
71878814|NCT02414399|143277514|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.088|||||||Chi-squared|||Month 3||||0.088
71878815|NCT02414399|143277514|SUPERIORITY|We modelled azithromycin resistance in E coli at baseline, 3 months, and 6 months of follow-up by randomisation group using generalised estimating equations with a Poisson link and exchangeable correlation structure, including site in the model. Models included an interaction term between randomisation group and follow-up timepoint (month 3 or month 6) to test whether an effect on resistance waned with time.||||||0.44|||||||Chi-squared|||M6||||0.44
71685991|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.52|STANDARD_ERROR_OF_MEAN|0.41||0.203|TWO_SIDED|95.0|-1.33|0.28||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.28|-1.33|0.203
71685992|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.46|0.49||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.49|-0.46|0.950
71685993|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.01|STANDARD_ERROR_OF_MEAN|0.24||0.95|TWO_SIDED|95.0|-0.45|0.48||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.48|-0.45|0.950
71685994|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.23||0.792|TWO_SIDED|95.0|-0.39|0.51||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.39|0.792
71878816|NCT00937937|143277521|SUPERIORITY_OR_OTHER_LEGACY||1-year overall survival estimate|0.38|||||TWO_SIDED|95.0|0.27|0.49||||||one-year overall survival estimate.||0.49|0.27|
71685995|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.11|STANDARD_ERROR_OF_MEAN|0.23||0.631|TWO_SIDED|95.0|-0.34|0.55||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.55|-0.34|0.631
71685996|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.24||0.691|TWO_SIDED|95.0|-0.38|0.58||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.58|-0.38|0.691
71685997|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.24||0.801|TWO_SIDED|95.0|-0.53|0.41||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.41|-0.53|0.801
71685998|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.93|STANDARD_ERROR_OF_MEAN|0.5||0.065|TWO_SIDED|95.0|-0.06|1.92||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.92|-0.06|0.065
71685999|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.54|STANDARD_ERROR_OF_MEAN|0.49||0.274|TWO_SIDED|95.0|-0.43|1.51||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.51|-0.43|0.274
71686000|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.48|STANDARD_ERROR_OF_MEAN|0.53||0.359|TWO_SIDED|95.0|-0.55|1.52||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.52|-0.55|0.359
71686001|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.09|STANDARD_ERROR_OF_MEAN|0.52||0.863|TWO_SIDED|95.0|-0.93|1.11||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.11|-0.93|0.863
71686002|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.56|STANDARD_ERROR_OF_MEAN|0.56||0.314|TWO_SIDED|95.0|-0.53|1.66||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.66|-0.53|0.314
71686003|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.06|STANDARD_ERROR_OF_MEAN|0.54||0.91|TWO_SIDED|95.0|-1.13|1.01||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.01|-1.13|0.910
71686004|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.19|STANDARD_ERROR_OF_MEAN|0.3||0.532|TWO_SIDED|95.0|-0.4|0.78||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.78|-0.40|0.532
71878817|NCT00937937|143277522|SUPERIORITY_OR_OTHER_LEGACY||6-month PFS estimate|0.07|||||TWO_SIDED|95.0|0.03|0.15||||||6-month PFS estimate.||0.15|0.03|
71878818|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.9|||||TWO_SIDED|95.0|1.58|2.28||||||A/H1N1: 60-64 years||2.28|1.58|
71686005|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|0.3||0.62|TWO_SIDED|95.0|-0.43|0.73||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.73|-0.43|0.620
71686006|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.08|STANDARD_ERROR_OF_MEAN|0.3||0.792|TWO_SIDED|95.0|-0.67|0.51||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.51|-0.67|0.792
71919171|NCT02442765|143360285|SUPERIORITY||SPCD OLS weighted z-statistic|-0.72|||=|0.471|TWO_SIDED||||||ANCOVA|||||||=0.471
71919172|NCT02442765|143360285|SUPERIORITY||SPCD OLS weighted z-statistic|0.5|||=|0.618|TWO_SIDED||||||ANCOVA|||||||=0.618
71686007|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.29||0.41|TWO_SIDED|95.0|-0.82|0.34||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.34|-0.82|0.410
71686008|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.34||0.955||95.0|-0.68|0.65||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.65|-0.68|0.955
71686009|NCT01026818|142889990|SUPERIORITY_OR_OTHER||LS Mean Differences|0.05|STANDARD_ERROR_OF_MEAN|0.33||0.868|TWO_SIDED|95.0|-0.59|0.7||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.70|-0.59|0.868
71686010|NCT01026818|142889991|SUPERIORITY_OR_OTHER||LS Mean Differences|0.33|STANDARD_ERROR_OF_MEAN|0.12||0.005|TWO_SIDED|95.0|0.1|0.56||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.56|0.10|0.005
71686011|NCT01026818|142889991|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|0.11||0.041|TWO_SIDED|95.0|0.01|0.45||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.45|0.01|0.041
71686012|NCT01026818|142889991|SUPERIORITY_OR_OTHER||LS Mean Differences|0.28|STANDARD_ERROR_OF_MEAN|0.13||0.035||95.0|0.02|0.54||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.54|0.02|0.035
71686013|NCT01026818|142889991|SUPERIORITY_OR_OTHER||LS Mean Differences|0.13|STANDARD_ERROR_OF_MEAN|0.13||0.316|TWO_SIDED|95.0|-0.12|0.38||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.38|-0.12|0.316
71878819|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.7|||||TWO_SIDED|95.0|1.38|2.08||||||A/H3N2: 60-64 years||2.08|1.38|
71878820|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.51|||||TWO_SIDED|95.0|1.3|1.74||||||B1: 60-64 years||1.74|1.30|
71878821|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.77|||||TWO_SIDED|95.0|1.53|2.04||||||B2: 60-64 years||2.04|1.53|
71878822|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.44|2.15||||||A/H1N1: \>=65 years||2.15|1.44|
71919173|NCT01200758|143360292|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.|Geometric mean ratio|1.62|||||TWO_SIDED|90.0|1.36|1.94|||||Geometric mean ratio adjusted for tumor load at baseline.|||1.94|1.36|
71686014|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|1.75|STANDARD_ERROR_OF_MEAN|1.02||0.086|TWO_SIDED|95.0|-0.25|3.76||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.76|-0.25|0.086
71686015|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|0.47|STANDARD_ERROR_OF_MEAN|1.0||0.637|TWO_SIDED|95.0|-1.5|2.45||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.45|-1.50|0.637
71686016|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|1.2||0.885|TWO_SIDED|95.0|-2.18|2.53||P-value is for sexual relationship - Month 13.5|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.53|-2.18|0.885
71686017|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|1.17||0.972|TWO_SIDED|95.0|-2.34|2.25||P-value is for sexual relationship - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.25|-2.34|0.972
71686018|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|0.27|STANDARD_ERROR_OF_MEAN|0.55||0.621|TWO_SIDED|95.0|-0.81|1.36||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.36|-0.81|0.621
71686019|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|STANDARD_ERROR_OF_MEAN|0.54||0.598|TWO_SIDED|95.0|-0.78|1.35||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.35|-0.78|0.598
71878823|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|2.15|||||TWO_SIDED|95.0|1.74|2.65||||||A/H3N2: \>=65 years||2.65|1.74|
71686020|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|0.06|STANDARD_ERROR_OF_MEAN|0.59||0.923|TWO_SIDED|95.0|-1.1|1.21||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.21|-1.10|0.923
71686021|NCT01026818|142889992|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.857|TWO_SIDED|95.0|-1.03|1.24||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.24|-1.03|0.857
71686022|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|14.87|STANDARD_ERROR_OF_MEAN|5.57||0.008|TWO_SIDED|95.0|3.92|25.83||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.83|3.92|0.008
71686023|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|11.34|STANDARD_ERROR_OF_MEAN|5.45||0.038|TWO_SIDED|95.0|0.63|22.04||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.04|0.63|0.038
71878824|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.55|||||TWO_SIDED|95.0|1.34|1.79||||||B1: \>=65 years||1.79|1.34|
71878825|NCT04024228|143277527|SUPERIORITY|Superiority of GMTs was concluded if the lower limit of the 2-sided 95% CI for the ratio of GMTs was above 1 between groups for each of the comparisons.|GMT ratio|1.76|||||TWO_SIDED|95.0|1.52|2.03||||||B2: \>=65 years||2.03|1.52|
71919174|NCT01200758|143360293|SUPERIORITY_OR_OTHER||Difference in response rates|-4.82||||0.2835|TWO_SIDED|95.0|-14.0|4.4|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.4|-14.0|0.2835
71919175|NCT01200758|143360293|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71|||||TWO_SIDED|95.0|0.38|1.33||||||||1.33|0.38|
71686024|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|8.91|STANDARD_ERROR_OF_MEAN|6.15||0.148|TWO_SIDED|95.0|-3.18|21.0||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||21.00|-3.18|0.148
71686025|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|5.37|STANDARD_ERROR_OF_MEAN|6.03||0.373|TWO_SIDED|95.0|-6.48|17.23||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.23|-6.48|0.373
71878826|NCT02015442|143277597|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||Baseline vs. treatment period||||0.390
71878827|NCT02015442|143277597|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||Baseline vs treatment||||0.204
71919176|NCT01200758|143360294|SUPERIORITY_OR_OTHER||Difference in response rates|7.66||||0.2047|TWO_SIDED|95.0|-5.0|20.3|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||20.3|-5.0|0.2047
71919177|NCT01200758|143360294|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||||TWO_SIDED|95.0|0.68|5.71||||||||5.71|0.68|
71919178|NCT01200758|143360295|SUPERIORITY_OR_OTHER||Difference in response rates|-0.49||||0.8911|TWO_SIDED|95.0|-7.7|6.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson.|||6.8|-7.7|0.8911
71878828|NCT02015442|143277598|SUPERIORITY|||||||0.001||||||calculated|t-test, 2 sided|||Baseline vs treatment||||0.001
71878829|NCT02015442|143277598|SUPERIORITY|||||||0.244|||||||t-test, 2 sided|||Baseline vs treatment||||0.244
71878830|NCT02015442|143277598|SUPERIORITY|||||||0.244|||||||ANOVA|||||||0.244
71878831|NCT04013789|143277599|NON_INFERIORITY|The noninferiority margin was set at 0.05.|Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.006|||ONE_SIDED|95.0||0.03|||Mixed Effects Repeated Measures Model||DACP FreshTech minus DACP|||0.03||
71878832|NCT05714982|143277600|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878833|NCT05714982|143277600|SUPERIORITY|||||||0.78|||||||General linear model|||||||.78
71878834|NCT05714982|143277601|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71686026|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|10.9|STANDARD_ERROR_OF_MEAN|4.96||0.029|TWO_SIDED|95.0|1.14|20.66||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.66|1.14|0.029
71686027|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|4.53|STANDARD_ERROR_OF_MEAN|4.91||0.357|TWO_SIDED|95.0|-5.12|14.17||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||14.17|-5.12|0.357
71686028|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|16.33|STANDARD_ERROR_OF_MEAN|5.42||0.003|TWO_SIDED|95.0|5.68|26.98||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||26.98|5.68|0.003
71686029|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|6.62|STANDARD_ERROR_OF_MEAN|5.3||0.212|TWO_SIDED|95.0|-3.8|17.04||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.04|-3.80|0.212
71686030|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|4.55|STANDARD_ERROR_OF_MEAN|6.17||0.461|TWO_SIDED|95.0|-7.58|16.68||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.68|-7.58|0.461
71686031|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.26|STANDARD_ERROR_OF_MEAN|6.05||0.835|TWO_SIDED|95.0|-13.16|10.63||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.63|-13.16|0.835
71686032|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|13.36|STANDARD_ERROR_OF_MEAN|6.15||0.03|TWO_SIDED|95.0|1.27|25.46||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||25.46|1.27|0.030
71686033|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|5.96|STANDARD_ERROR_OF_MEAN|6.07||0.326|TWO_SIDED|95.0|-5.97|17.89||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.89|-5.97|0.326
71686034|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|12.06|STANDARD_ERROR_OF_MEAN|5.13||0.019||95.0|1.98|22.15||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||22.15|1.98|0.019
71686035|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|2.48|STANDARD_ERROR_OF_MEAN|5.02||0.621|TWO_SIDED|95.0|-7.38|12.35||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.35|-7.38|0.621
71686036|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|0.23|STANDARD_ERROR_OF_MEAN|5.73||0.968||95.0|-11.03|11.49||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||11.49|-11.03|0.968
71686037|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.51|STANDARD_ERROR_OF_MEAN|5.62||0.327|TWO_SIDED|95.0|-16.55|5.54||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.54|-16.55|0.327
71686038|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|11.67|STANDARD_ERROR_OF_MEAN|6.32||0.066|TWO_SIDED|95.0|-0.76|24.09||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||24.09|-0.76|0.066
71686039|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|5.09|STANDARD_ERROR_OF_MEAN|6.23||0.415|TWO_SIDED|95.0|-7.17|17.34||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.34|-7.17|0.415
71686040|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|11.87|STANDARD_ERROR_OF_MEAN|4.61||0.011|TWO_SIDED|95.0|2.79|20.94||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.94|2.79|0.011
71686041|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|3.85|STANDARD_ERROR_OF_MEAN|4.51||0.394|TWO_SIDED|95.0|-5.03|12.72||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.72|-5.03|0.394
71686042|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.94|STANDARD_ERROR_OF_MEAN|4.75||0.684|TWO_SIDED|95.0|-11.28|7.41||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.41|-11.28|0.684
71686043|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|-7.14|STANDARD_ERROR_OF_MEAN|4.66||0.126|TWO_SIDED|95.0|-16.3|2.02||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.02|-16.30|0.126
71686044|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|11.52|STANDARD_ERROR_OF_MEAN|6.13||0.061|TWO_SIDED|95.0|-0.53|23.57||P-value is for Q4 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.57|-0.53|0.061
71686045|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|5.06|STANDARD_ERROR_OF_MEAN|6.05||0.403|TWO_SIDED|95.0|-6.83|16.95||P-value is for Q4 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||16.95|-6.83|0.403
71878835|NCT05714982|143277601|SUPERIORITY|||||||0.66|||||||General linear model|||||||.66
71878836|NCT05714982|143277602|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878837|NCT05714982|143277602|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878838|NCT05714982|143277603|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
71878839|NCT05714982|143277603|SUPERIORITY|||||||0.95|||||||General linear model|||||||.95
71878840|NCT05714982|143277604|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878841|NCT05714982|143277604|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878842|NCT05714982|143277605|SUPERIORITY||||||<|0.0001|||||||General linear model|||||||<.0001
71878843|NCT05714982|143277605|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878844|NCT05714982|143277606|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878845|NCT05714982|143277606|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
71878846|NCT05714982|143277607|SUPERIORITY|||||||0.03|||||||General linear model|||||||.03
71878847|NCT05714982|143277607|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
71878848|NCT05714982|143277608|SUPERIORITY|||||||0.61|||||||General linear model|||||||.61
71878849|NCT05714982|143277608|SUPERIORITY|||||||0.68|||||||General linear model|||||||.68
71878850|NCT05714982|143277609|SUPERIORITY|||||||0.4|||||||General linear model|||||||.4
71878851|NCT05714982|143277609|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
71878852|NCT05714982|143277610|SUPERIORITY|||||||0.001|||||||General linear model|||||||.001
71878853|NCT05714982|143277610|SUPERIORITY|||||||0.9|||||||General linear model|||||||.9
71878854|NCT05714982|143277611|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.73|1.2||||||||1.2|.73|
71878855|NCT05714982|143277611|SUPERIORITY||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.69|1.2||||||||1.2|.69|
71878856|NCT05714982|143277612|SUPERIORITY||Odds Ratio (OR)|0.5|||||TWO_SIDED|95.0|0.3|0.9||||||||.9|.3|
71878857|NCT05714982|143277612|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.6|1.7||||||||1.7|.6|
71878858|NCT05714982|143277613|SUPERIORITY|||||||0.02|||||||General linear model|||||||.02
71878859|NCT05714982|143277613|SUPERIORITY|||||||0.5|||||||General linear model|||||||.5
71878860|NCT05714982|143277614|SUPERIORITY||||||<|0.001|||||||General linear model|||||||<.001
71878861|NCT05714982|143277614|SUPERIORITY|||||||0.004|||||||General linear model|||||||.004
71878862|NCT05714982|143277615|SUPERIORITY|||||||0.3|||||||General linear model|||||||0.3
71878863|NCT05714982|143277615|SUPERIORITY|||||||0.5|||||||General linear model|||||||0.5
71878864|NCT05714982|143277616|SUPERIORITY||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.99|2.1||||||||2.1|.99|
71878865|NCT05714982|143277616|SUPERIORITY||Odds Ratio (OR)|1.8|||||TWO_SIDED|95.0|1.2|2.6||||||||2.6|1.2|
71878866|NCT00549939|143277617|SUPERIORITY_OR_OTHER|||||||1||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||1.00
71878867|NCT00549939|143277617|SUPERIORITY_OR_OTHER|||||||0.91||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||||||0.91
71878868|NCT00549939|143277619|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-6.2|STANDARD_ERROR_OF_MEAN|3.8||0.104|TWO_SIDED|95.0|-13.72|1.29||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||1.29|-13.72|0.1040
71878869|NCT00549939|143277619|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-7.1|STANDARD_ERROR_OF_MEAN|3.77||0.104|TWO_SIDED|95.0|-14.51|0.39||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.39|-14.51|0.1040
71882633|NCT02706873|143284643|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-1.19|||<|0.001|TWO_SIDED|95.0|-1.4|-0.99||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.99|-1.40|<0.001
71919179|NCT01200758|143360295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.56|1.65||||||||1.65|0.56|
71919180|NCT01200758|143360296|SUPERIORITY_OR_OTHER||Difference in CRR|17.86||||0.0335|TWO_SIDED|95.0|0.8|35.0|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||35.0|0.8|0.0335
71919181|NCT01200758|143360296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|1.06|4.78||||||||4.78|1.06|
71919182|NCT01200758|143360297|SUPERIORITY_OR_OTHER||Difference in response rates|-6.58||||0.2331|TWO_SIDED|95.0|-17.8|4.6|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||4.6|-17.8|0.2331
71919183|NCT01200758|143360297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74|||||TWO_SIDED|95.0|0.44|1.22||||||||1.22|0.44|
71919184|NCT01200758|143360298|SUPERIORITY_OR_OTHER||Difference in response rates|0.49||||0.9157|TWO_SIDED|95.0|-8.8|9.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||9.8|-8.8|0.9157
71919185|NCT01200758|143360298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.66|1.51||||||||1.51|0.66|
71919186|NCT01200758|143360299|SUPERIORITY_OR_OTHER||Difference in response rates|-7.28||||0.1715|TWO_SIDED|95.0|-18.0|3.5|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||3.5|-18.0|0.1715
71919187|NCT01200758|143360299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8|||||TWO_SIDED|95.0|0.52|1.22||||||||1.22|0.52|
71919188|NCT01200758|143360300|SUPERIORITY_OR_OTHER||Difference in response rates|-0.18||||0.9671|TWO_SIDED|95.0|-9.2|8.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.|||8.8|-9.2|0.9671
71919189|NCT01200758|143360300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.6|1.64||||||||1.64|0.60|
71686046|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|11.38|STANDARD_ERROR_OF_MEAN|4.58||0.013||95.0|2.38|20.38||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||20.38|2.38|0.013
71686047|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|3.69|STANDARD_ERROR_OF_MEAN|4.47||0.41|TWO_SIDED|95.0|-5.11|12.49||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||12.49|-5.11|0.410
71686048|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|-2.85|STANDARD_ERROR_OF_MEAN|4.61||0.537|TWO_SIDED|95.0|-11.92|6.22||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.22|-11.92|0.537
71686049|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|-8.59|STANDARD_ERROR_OF_MEAN|4.52||0.058|TWO_SIDED|95.0|-17.48|0.3||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||0.30|-17.48|0.058
71686050|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|11.44|STANDARD_ERROR_OF_MEAN|6.09||0.061|TWO_SIDED|95.0|-0.54|23.41||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||23.41|-0.54|0.061
71686051|NCT01026818|142890003|SUPERIORITY_OR_OTHER||LS Mean Differences|5.59|STANDARD_ERROR_OF_MEAN|6.01||0.353|TWO_SIDED|95.0|-6.23|17.4||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||17.40|-6.23|0.353
71686052|NCT01026818|142890004|SUPERIORITY_OR_OTHER||LS Mean Differences|-5.12|STANDARD_ERROR_OF_MEAN|3.66||0.162|TWO_SIDED|95.0|-12.32|2.08|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||2.08|-12.32|0.162
71686053|NCT01026818|142890004|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.88|STANDARD_ERROR_OF_MEAN|3.61||0.603||95.0|-8.99|5.24|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.||||5.24|-8.99|0.603
71686054|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|3.49|STANDARD_ERROR_OF_MEAN|2.7||0.196|TWO_SIDED|95.0|-1.82|8.8||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||8.80|-1.82|0.196
71686055|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|0.53|STANDARD_ERROR_OF_MEAN|2.65||0.841|TWO_SIDED|95.0|-4.69|5.75||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.75|-4.69|0.841
71878870|NCT00549939|143277620|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-11.4|STANDARD_ERROR_OF_MEAN|7.54||0.1338|TWO_SIDED|95.0|-26.27|3.53||P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."||3.53|-26.27|0.1338
71878871|NCT00549939|143277620|SUPERIORITY_OR_OTHER||LS Mean difference versus Placebo|-14.3|STANDARD_ERROR_OF_MEAN|7.48||0.1152|TWO_SIDED|95.0|-29.1|0.47||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||0.47|-29.10|0.1152
71878872|NCT00549939|143277622|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~* treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~* age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~* anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor compliance as covariate."||||0.7889
71919190|NCT01200758|143360302|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.5526|TWO_SIDED|95.0|0.64|1.26|||Wald test|||||1.26|0.64|0.5526
71686056|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|1.98|STANDARD_ERROR_OF_MEAN|2.76||0.474|TWO_SIDED|95.0|-3.45|7.4||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||7.40|-3.45|0.474
71686057|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|2.7||0.971|TWO_SIDED|95.0|-5.21|5.41||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.41|-5.21|0.971
71686058|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|1.57|STANDARD_ERROR_OF_MEAN|1.32||0.236|TWO_SIDED|95.0|-1.03|4.17||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.17|-1.03|0.236
71686059|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|1.02|STANDARD_ERROR_OF_MEAN|1.29||0.429|TWO_SIDED|95.0|-1.52|3.56||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||3.56|-1.52|0.429
71878873|NCT00549939|143277622|SUPERIORITY_OR_OTHER|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||||||0.7889
71878874|NCT05197049|143277644|SUPERIORITY||Adjusted treatment difference:percentage|34.9|||<|0.001|TWO_SIDED|95.0|25.1|44.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||44.6|25.1|< 0.001
71878875|NCT05197049|143277645|SUPERIORITY||Adjusted treatment difference:percentage|19.9|||<|0.001|TWO_SIDED|95.0|10.2|29.6|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||29.6|10.2|< 0.001
71878876|NCT05197049|143277646|SUPERIORITY||Adjusted treatment difference:percentage|37.0|||<|0.001|TWO_SIDED|95.0|25.6|48.4|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||48.4|25.6|< 0.001
71878877|NCT05197049|143277646|SUPERIORITY||Adjusted treatment difference:percentage|39.3|||<|0.001|TWO_SIDED|95.0|28.0|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|28.0|< 0.001
71878878|NCT05197049|143277647|SUPERIORITY||Adjusted treatment difference:percentage|32.1|||<|0.001|TWO_SIDED|95.0|22.9|41.2|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||41.2|22.9|< 0.001
71878879|NCT05197049|143277648|SUPERIORITY||Adjusted treatment difference:percentage|40.3|||<|0.001|TWO_SIDED|95.0|29.9|50.7|||Mantel Haenszel|Mantel-Haenszel stratum weights and the Sato variance estimator.||||50.7|29.9|< 0.001
71878880|NCT00309465|143277652|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||P-value for three dosing strategies in insulin glargine only group in fasting blood glucose achievement of 100-179 mg/dl range.|Chi-squared|||Comparison for Target Blood Glucose Achievement of 100-179 mg/dl||||0.332
71878881|NCT00309465|143277652|SUPERIORITY_OR_OTHER|||||||0.294||95.0||||P value is for three strategies in insulin glargine plus bolus group for fasting blood glucose achievement of 100-179 mg/dl|Chi-squared|||Comparison for Target Achievement of blood glucose values of 100-179 mg/dl||||0.294
71878882|NCT00309465|143277652|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||P value is for three strategies in insulin glargine only group for achievement of 80-249 mg/dl|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl||||0.162
71878883|NCT00309465|143277652|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||P value is for three strategies in insulin glargine plus bolus group in achievement of fasting blood glucose value of 80-249 mg/dl.|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl.||||0.031
71878884|NCT02577406|143277653|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.2288|TWO_SIDED|95.0|0.67|1.1|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory|||1.10|0.67|0.2288
71878885|NCT02577406|143277654|SUPERIORITY||Odds Ratio (OR)|6.08|||<|0.0001|TWO_SIDED|95.0|3.32|11.14||p-value from a Cochran-Mantel-Haenszel test comparing the response rates between the AG-221 group and the combined CCR group with stratification factors of prior intensive therapy for AML and primary refractory status|Cochran-Mantel-Haenszel||Odds ratio from logistic regression|||11.14|3.32|<0.0001
71878886|NCT02577406|143277655|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.02|TWO_SIDED|95.0|0.55|0.95|||Stratified Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status.|||0.95|0.55|0.0200
71878887|NCT02577406|143277661|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71878888|NCT02577406|143277662|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71919191|NCT01200758|143360304|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.9115|TWO_SIDED|95.0|0.71|1.36|||Wald test|||||1.36|0.71|0.9115
71919192|NCT01200758|143360307|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.38|||||TWO_SIDED|90.0|1.24|1.53||||||The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.||1.53|1.24|
71919193|NCT01200758|143360308|SUPERIORITY_OR_OTHER||Geometric mean ratio|0.941|||||TWO_SIDED|95.0|0.872|1.015||||||||1.015|0.872|
71878889|NCT02577406|143277663|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71878890|NCT02577406|143277665|SUPERIORITY||Hazard Ratio (HR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.41|0.67|||Stratified Log Rank||The hazard ratio was from a Cox proportional hazards model stratified by prior intensive therapy for AML and primary refractory status|||0.67|0.41|<0.0001
71878891|NCT04033445|143277673|SUPERIORITY||Adjusted treatment difference|33.6|||<|0.001|TWO_SIDED|95.0|20.9|46.3|||Cochran-Mantel-Haenszel (CMH) chi-square||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||46.3|20.9|< 0.001
71878892|NCT04033445|143277673|SUPERIORITY||Adjusted treatment difference|33.1|||<|0.001|TWO_SIDED|95.0|20.8|45.4|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||45.4|20.8|< 0.001
71919194|NCT01795716|143360326|NON_INFERIORITY_OR_EQUIVALENCE|The 90%CIs of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|||||<|0.05|TWO_SIDED||||||ANOVA|||The 90% confidence intervals of the test/reference ratios for AUC0-∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.||||<0.05
71919195|NCT03525613|143360327|SUPERIORITY||LS Mean Difference|-0.4114||||0.0004|TWO_SIDED|95.0|-0.6397|-0.1831|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of choroidal neovascularization (CNV) in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.1831|-0.6397|0.0004
71878893|NCT04033445|143277674|SUPERIORITY||Adjusted treatment difference|14.9|||<|0.001|TWO_SIDED|95.0|9.9|19.9|||CMH chi-square test||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||19.9|9.9|< 0.001
71878894|NCT04033445|143277675|SUPERIORITY||Adjusted treatment difference|25.2|||<|0.001|TWO_SIDED|95.0|16.4|33.9|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||33.9|16.4|< 0.001
71878895|NCT04033445|143277675|SUPERIORITY||Adjusted treatment difference|29.5|||<|0.001|TWO_SIDED|95.0|20.9|38.1|||Cochran-Mantel-Haenszel||Treatment difference between guselkumab group and placebo group was adjusted with CMH weight.|||38.1|20.9|< 0.001
71878896|NCT04754802|143277712|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|2.42||0.5063|TWO_SIDED|95.0|-3.2|6.4|||ANCOVA|||||6.4|-3.2|.5063
71878897|NCT04754802|143277713|SUPERIORITY||Other|-0.015||||0.8077|TWO_SIDED|95.0|-0.137|0.107|||Wald Normal Approximation (Z)|Wald Normal Approximation (Z) for difference between two proportions||||0.107|-0.137|.8077
71878898|NCT04451161|143277714|SUPERIORITY|||||||0.591||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.591
71919196|NCT03525613|143360327|SUPERIORITY||LS Mean Difference|-0.318||||0.0055|TWO_SIDED|95.0|-0.5423|-0.0937|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area × analysis visit.||-0.0937|-0.5423|0.0055
71878899|NCT04451161|143277714|SUPERIORITY|||||||0.032||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.032
71919197|NCT03525613|143360328|SUPERIORITY||LS Mean Difference|-0.9015|||<|0.0001|TWO_SIDED|95.0|-1.3026|-0.5004|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.5004|-1.3026|<0.0001
71919198|NCT03525613|143360328|SUPERIORITY||LS Mean Difference|-0.7426||||0.0002|TWO_SIDED|95.0|-1.1282|-0.357|||MMRM model|||Model included treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) + analysis visit + baseline presence of CNV in the fellow eye (yes or no) + analysis visit × treatment + baseline GA lesion area (\<7.5 mm\^2 or ≥7.5 mm\^2) × analysis visit.||-0.3570|-1.1282|0.0002
71919199|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2234||||0.0007|TWO_SIDED|95.0|-0.3522|-0.0946|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0946|-0.3522|0.0007
71919200|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1618||||0.0116|TWO_SIDED|95.0|-0.2874|-0.0361|||MMRM model|||Estimates for Baseline to Month 6: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0361|-0.2874|0.0116
71919201|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1862||||0.0181|TWO_SIDED|95.0|-0.3406|-0.0318|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0318|-0.3406|0.0181
71878900|NCT04451161|143277714|SUPERIORITY|||||||0.054||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants administered the CPSS-V to at least one student by the end of the sustainment phase.|Chi-squared|||One of the primary TF-CBT adoption outcomes (defined as administered CPSS-V) was binary: either the participant adopted at least one of these components with a student at the end of the sustainment phase, or they did not. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.054
71878901|NCT04451161|143277714|SUPERIORITY|||||||0.98||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student at the beginning of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not at the beginning of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.98
71878902|NCT04451161|143277714|SUPERIORITY|||||||0.068||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.068
71878903|NCT04451161|143277714|SUPERIORITY|||||||0.165||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants started TF-CBT with at least one student by the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as started TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.165
71878904|NCT04451161|143277714|SUPERIORITY|||||||0.191||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student by the end of the active phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the active phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.191
71878905|NCT04451161|143277714|SUPERIORITY|||||||0.86||||||We performed a chi-squared analysis comparing the study groups (BASIS vs. Attention Control) on whether participants completed TF-CBT with at least one student at the end of the sustainment phase.|Chi-squared|||The primary TF-CBT adoption outcome (defined as completed TF-CBT) was binary: either the participant adopted at least one of these components with a student, or they did not by the end of the sustainment phase. A chi-squared test was used as a superiority test to determine whether participants in the BASIS group had higher TF-CBT adoption rates compared to the Attention Control group.||||0.86
71878906|NCT04451161|143277715|SUPERIORITY||Slope|3.425|STANDARD_ERROR_OF_MEAN|2.783||0.22|TWO_SIDED|95.0|-2.064|8.915||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||8.915|-2.064|0.22
71878907|NCT04451161|143277715|SUPERIORITY||Slope|4.97|STANDARD_ERROR_OF_MEAN|2.774||0.075|TWO_SIDED|95.0|-0.502|10.443||Mixed model analysis was used (the students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing trauma PTSD symptoms (measured using CPSS-V) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT reduced trauma-related PTSD symptoms over time, as measured by CPSS-V scores (higher scores indicate greater symptom severity).||10.443|-.502|0.075
71878908|NCT04451161|143277716|SUPERIORITY||Slope|1.024|STANDARD_ERROR_OF_MEAN|0.952||0.284|TWO_SIDED|95.0|-0.855|2.904||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if BASIS+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the BASIS group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||2.904|-.855|0.284
71878909|NCT04451161|143277716|SUPERIORITY||Slope|1.908|STANDARD_ERROR_OF_MEAN|0.951||0.046|TWO_SIDED|95.0|0.03|3.786||Mixed model analysis was used (students were clustered under the providers who recruited them) to understand if AC+TF-CBT has a greater effect on decreasing negative mood and feelings symptoms (measured using SMFQ) over time.|Mixed Models Analysis|||We compared the AC group (receiving TF-CBT) against Enhanced Treatment as Usual to evaluate whether TF-CBT decreased children's negative moods and feelings due to their trauma (higher score indicates more negative mood and feelings).||3.786|.03|.046
71878910|NCT01671111|143277722|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.0560
71878911|NCT01671111|143277723|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1232|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1232
71878912|NCT01671111|143277724|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1319|TWO_SIDED|||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test|||||||0.1319
71878913|NCT01671111|143277725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8061|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.8061
71878914|NCT01671111|143277726|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2297|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.2297
71878915|NCT01671111|143277727|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1248|TWO_SIDED|||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test|||||||0.1248
71919202|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1526||||0.0467|TWO_SIDED|95.0|-0.303|-0.0023|||MMRM model|||Estimates for Month 6 to Month 12: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0023|-0.3030|0.0467
71919203|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2265||||0.0019|TWO_SIDED|95.0|-0.3696|-0.0834|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0834|-0.3696|0.0019
71919204|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.1586||||0.0288|TWO_SIDED|95.0|-0.3009|-0.0164|||MMRM model|||Estimates for Month 12 to Month 18: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0164|-0.3009|0.0288
71919205|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2341||||0.008|TWO_SIDED|95.0|-0.4071|-0.0611|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.0611|-0.4071|0.0080
71919206|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.2459||||0.0007|TWO_SIDED|95.0|-0.3886|-0.1031|||MMRM model|||Estimates for Month 18 to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.1031|-0.3886|0.0007
71922334|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccines Group Differences at Day 86|4.0|||||TWO_SIDED|97.5|-8.6|17.4|||MN method|||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW||17.4|-8.6|
71686060|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|1.56|STANDARD_ERROR_OF_MEAN|1.36||0.252|TWO_SIDED|95.0|-1.12|4.24||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.24|-1.12|0.252
71878916|NCT02504554|143277757|OTHER||||||<|0.001||||||"no adjustment for multiple hypothesis testing since this was an exploratory study.~the p-value listed is the actual result from analysis of the study data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank analysis of symptoms at 10 weeks (end of treatment) vs. baseline||||<0.001
71878917|NCT02504554|143277758|OTHER|paired 2-sided t-test comparing baseline and 10 weeks (end of treatment)|||||<|0.001||||||no adjustment for multiple comparisons|t-test, 2 sided|paired t-test, 2 sided||||||<0.001
71878918|NCT02504554|143277760|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~The p-value listed is the result for the actual analysis of the data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing the baseline score vs. the score at 10 weeks (end of treatment).||||<0.001
71878919|NCT02504554|143277761|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the study results."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing scores at baseline vs. 10 weeks (end of treatment)||||<0.001
71878920|NCT02504554|143277763|OTHER||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the analysis of the study data"|t-test, 2 sided|||2-sided t-test comparing the group at baseline vs. 18 weeks (8 weeks after end of treatment)||||<0.001
71878921|NCT02504554|143277764|OTHER|||||||0.002||||||no adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare scores at baseline vs. at 10 weeks (end of treatment)||||0.002
71878922|NCT01806857|143277765|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Random Effects Model|||||||0.0003
71878923|NCT01806857|143277769|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Random Effects Model|||||||0.0001
71882634|NCT02706873|143284644|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.17|-0.37|<0.001
71882635|NCT02706873|143284644|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.31|||<|0.001|TWO_SIDED|95.0|-0.41|-0.21||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||-0.21|-0.41|<0.001
71882636|NCT02706873|143284645|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|26.8|||<|0.001|TWO_SIDED|95.0|19.3|34.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||34.3|19.3|<0.001
71882637|NCT02706873|143284645|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.2|||<|0.001|TWO_SIDED|95.0|24.8|39.6||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||39.6|24.8|<0.001
71882638|NCT02706873|143284646|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|27.8|||<|0.001|TWO_SIDED|95.0|20.3|35.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||35.2|20.3|<0.001
71882639|NCT02706873|143284646|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.8|||<|0.001|TWO_SIDED|95.0|25.4|40.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||40.2|25.4|<0.001
71882640|NCT02706873|143284647|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|3.72|||<|0.001|TWO_SIDED|95.0|2.42|5.03||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.03|2.42|<0.001
71882641|NCT02706873|143284647|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|4.42|||<|0.001|TWO_SIDED|95.0|3.12|5.72||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate|||5.72|3.12|<0.001
71882642|NCT02706873|143284648|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|9.8||||0.002|TWO_SIDED|95.0|3.5|16.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||16.2|3.5|0.002
71882643|NCT02706873|143284648|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|11.6|||<|0.001|TWO_SIDED|95.0|5.4|17.8||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||17.8|5.4|<0.001
71882644|NCT02706873|143284649|SUPERIORITY||Response Rate Difference|18.5|||<|0.001|TWO_SIDED|95.0|12.1|24.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||24.9|12.1|<0.001
71882645|NCT02706873|143284649|OTHER||Response Rate Difference|22.9|||<|0.001|TWO_SIDED|95.0|16.4|29.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||29.5|16.4|<0.001
71919207|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.8702|||<|0.0001|TWO_SIDED|95.0|-1.274|-0.4664|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.4664|-1.2740|<0.0001
71919208|NCT03525613|143360329|SUPERIORITY|Baseline GA lesion area x Time (continuous) + Baseline GA lesion area x Time Spline at Month 6 (continuous) + Baseline GA lesion area x Time Spline at Month 12 (continuous) + Baseline GA lesion area x Time Spline at Month 18 (continuous). A heterogeneous autoregressive covariance matrix was used to model within-subject errors.|Mean Difference|-0.7189||||0.0003|TWO_SIDED|95.0|-1.1039|-0.3339|||MMRM model|||Estimates for Baseline to Month 24: Model included Treatment + Baseline GA lesion area (\< 7.5 mm\^2 or \>= 7.5 mm\^2) + Time (continuous) + Time Spline at Month 6 (continuous) + Time Spline at Month 12 (continuous) + Time Spline at Month 18 (continuous) + Presence of CNV in the fellow eye (Yes or No) + Time (continuous) x Treatment + Time Spline at Month 6 (continuous) x Treatment + Time Spline at Month 12 (continuous) x Treatment + Time Spline at Month 18 (continuous) x Treatment +||-0.3339|-1.1039|0.0003
71919209|NCT02584660|143360343|SUPERIORITY||Mean difference|-1.202|||<|0.0001|TWO_SIDED|95.0|-1.73|-0.674|||t-test|||||-0.674|-1.730|<.0001
71919210|NCT00461552|143360349|SUPERIORITY|||||||0.84||||||Treatment time month interaction|Mixed Models Analysis|||||||0.84
71919211|NCT00461552|143360350|OTHER|||||||0.4||||||Treatment time month interaction|Mixed Models Analysis|||||||0.4
71919212|NCT00374452|143360351|OTHER||||||>|0.1|||||||Mixed Models Analysis|||We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.||||>0.1
71919213|NCT03099304|143360369|SUPERIORITY||Odds Ratio (OR)|13.79||||0.0057|TWO_SIDED|95.0|1.73|640.85||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||640.85|1.73|0.0057
71686061|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|1.52|STANDARD_ERROR_OF_MEAN|1.32||0.251|TWO_SIDED|95.0|-1.08|4.11||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.11|-1.08|0.251
71686062|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.54|STANDARD_ERROR_OF_MEAN|1.27||0.671|TWO_SIDED|95.0|-3.03|1.95||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||1.95|-3.03|0.671
71686063|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.21|STANDARD_ERROR_OF_MEAN|1.24||0.868|TWO_SIDED|95.0|-2.64|2.23||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.23|-2.64|0.868
71878924|NCT01020591|143277781|NON_INFERIORITY_OR_EQUIVALENCE|The power and sample size calculations, based on the ability to detect treatment and evaluation group differences, were performed on Minitab™ V.15. 40 participants were estimated to be required for group allocation (20 in each group: evaluation;evaluation and treatment)for 80% power in at least 3 out of the 4 outcome measures. After 30 subjects, analysis determined that there would be no further statistically significant changes in results therefore, data collection was stopped at 30 subjects.|||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Index||||<0.05
71686064|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|0.1|STANDARD_ERROR_OF_MEAN|1.25||0.938|TWO_SIDED|95.0|-2.37|2.57||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.57|-2.37|0.938
71686065|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.29|STANDARD_ERROR_OF_MEAN|1.22||0.813|TWO_SIDED|95.0|-2.69|2.12||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.12|-2.69|0.813
71686066|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|9.55|STANDARD_ERROR_OF_MEAN|3.28||0.004|TWO_SIDED|95.0|3.1|15.99||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||15.99|3.10|0.004
71686067|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|2.69|STANDARD_ERROR_OF_MEAN|3.21||0.403|TWO_SIDED|95.0|-3.63|9.0||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||9.00|-3.63|0.403
71686068|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|3.18|STANDARD_ERROR_OF_MEAN|3.82||0.406|TWO_SIDED|95.0|-4.34|10.69||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||10.69|-4.34|0.406
71686069|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.79|STANDARD_ERROR_OF_MEAN|3.72||0.832|TWO_SIDED|95.0|-8.11|6.53||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||6.53|-8.11|0.832
71686070|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|1.9|STANDARD_ERROR_OF_MEAN|1.47||0.197|TWO_SIDED|95.0|-0.99|4.79||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||4.79|-0.99|0.197
71686071|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|2.89|STANDARD_ERROR_OF_MEAN|1.44||0.045|TWO_SIDED|95.0|0.06|5.72||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||5.72|0.06|0.045
71686072|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.53|STANDARD_ERROR_OF_MEAN|1.34||0.692|TWO_SIDED|95.0|-3.16|2.1||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.10|-3.16|0.692
71686073|NCT01026818|142890008|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.09|STANDARD_ERROR_OF_MEAN|1.3||0.943|TWO_SIDED|95.0|-2.65|2.46||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10).||||2.46|-2.65|0.943
71686074|NCT01026818|142890009|SUPERIORITY_OR_OTHER||LS Mean Differences|4.2|STANDARD_ERROR_OF_MEAN|1.89||0.028|TWO_SIDED|95.0|0.47|7.93||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||7.93|0.47|0.028
71686075|NCT01026818|142890009|SUPERIORITY_OR_OTHER||LS Mean Differences|-1.53|STANDARD_ERROR_OF_MEAN|1.87||0.413|TWO_SIDED|95.0|-5.2|2.14||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||2.14|-5.20|0.413
71686076|NCT01026818|142890009|SUPERIORITY_OR_OTHER||LS Mean Differences|2.37|STANDARD_ERROR_OF_MEAN|1.49||0.112|TWO_SIDED|95.0|-0.55|5.3||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||5.30|-0.55|0.112
71686077|NCT01026818|142890009|SUPERIORITY_OR_OTHER||LS Mean Differences|3.16|STANDARD_ERROR_OF_MEAN|1.46||0.031|TWO_SIDED|95.0|0.29|6.03||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.||||6.03|0.29|0.031
71686078|NCT03543176|142890010|OTHER|||||||0.448||||||P-value for low impact of COPD is presented|Fisher Exact|||||||0.448
71878925|NCT00698997|143277795|OTHER|Non- equivalence.|slope difference|1.01||||0.03|TWO_SIDED||||||Mixed Models Analysis|||We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen's recommendations as f2.||||.03
71878926|NCT04272892|143277824|SUPERIORITY||Mean Difference (Final Values)|3.35|||<|0.021|TWO_SIDED|||||p values are calculated for original data (complete case) and each of the 5 imputed datasets. The p value range was 0.002 - 0.020. This is not multiple statistical analyses- it is just one with multiple imputations.|ANCOVA|Degrees of freedom for original data (complete case): 1,64. Degrees of freedom for imputed datasets: 1,80||||||<0.021
71686079|NCT03543176|142890010|OTHER|||||||0.033||||||P-value for medium impact of COPD is presented|Fisher Exact|||||||0.033
71686080|NCT03543176|142890010|OTHER|||||||0.172||||||P-value for high impact of COPD is presented|Fisher Exact|||||||0.172
71686081|NCT03543176|142890010|OTHER|||||||0.01||||||P-value for very high impact of COPD is presented|Fisher Exact|||||||0.010
71686082|NCT03543176|142890011|OTHER|||||||0.176||||||P-value for breathlessness reported in COPD assessed using mMRC is presented|Fisher Exact|||||||0.176
71686083|NCT03543176|142890012|OTHER|||||||0.732||||||P-value for Baseline comorbidity burden score was calculated.|t-test, 2 sided|||||||0.732
71686084|NCT03543176|142890013|OTHER|||||||0.013||||||P-value for count of unique medications was calculated.|t-test, 2 sided|||||||0.013
71686085|NCT03543176|142890014|OTHER|||||||0.178||||||P-value for total number of medications dispensing was calculated.|t-test, 2 sided|||||||0.178
71686086|NCT03543176|142890020|OTHER|||||||0.692||||||P-value for count of unique COPD medications was calculated|t-test, 2 sided|||||||0.692
71686087|NCT03543176|142890021|OTHER||||||<|0.001||||||P-value for total number of COPD medications dispensing was calculated|t-test, 2 sided|||||||<0.001
71686088|NCT03300050|142890039|OTHER||GMT Ratio|2.73|||<|0.0001|TWO_SIDED|95.0|1.73|4.29|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted Geometric Mean Titer (GMT) Ratio 28 Days Post-Boost Dose||4.29|1.73|<0.0001
71878927|NCT04272892|143277825|SUPERIORITY||Mean Difference (Final Values)|2.86||||0.059|TWO_SIDED|95.0|-0.106|5.822|||ANCOVA|ANCOVA of score at 8 week follow up with baseline score as covariate, effect of group||||5.822|-.106|0.059
71686089|NCT03300050|142890039|OTHER||GMT Ratio|1.06||||0.9411|TWO_SIDED|95.0|0.68|1.66|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.66|0.68|0.9411
71878928|NCT04272892|143277826|SUPERIORITY||Mean Difference (Final Values)|1.3||||0.596|TWO_SIDED|95.0|-3.5|6.0|||ANCOVA|ANCOVA of sleep fragmentation at post-intervention with baseline as covariate, effect of group||||6.0|-3.5|0.596
71878929|NCT04272892|143277827|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.031|TWO_SIDED|95.0|0.431|8.612|||ANCOVA|ANCOVA of sleep fragmentation at 8 week follow up with baseline as covariate, effect of group||||8.612|.431|0.031
71878930|NCT04272892|143277828|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.885|TWO_SIDED|95.0|-7.8|9.1|||ANCOVA|ANCOVA of wake after sleep onset post-intervention with baseline as covariate, effect of group||||9.1|-7.8|0.885
71878931|NCT04272892|143277829|SUPERIORITY||Mean Difference (Final Values)|8.0||||0.077|TWO_SIDED|95.0|-1.0|17.0|||ANCOVA|ANCOVA of wake after sleep onset at 8 week follow up with baseline as covariate, effect of group||||17|-1|0.077
71878932|NCT04272892|143277830|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.014|TWO_SIDED|95.0|2.0|18.0|||ANCOVA|ANCOVA of sleep onset latency (median of 7 nights) at end of intervention with baseline as covariate, effect of group||||18|2|0.014
71878933|NCT04272892|143277831|SUPERIORITY||Mean Difference (Final Values)|1.8||||0.03|TWO_SIDED|95.0|0.18|3.5|||ANCOVA|ANCOVA of PHQ9 score post-intervention with baseline as covariate, effect of group||||3.5|.18|0.03
71878934|NCT04272892|143277832|SUPERIORITY||Mean Difference (Final Values)|2.29||||0.036|TWO_SIDED|95.0|0.149|4.44|||ANCOVA|ANCOVA of PHQ9 score at 8 week follow up with baseline as covariate, effect of group||||4.44|.149|0.036
71878935|NCT04272892|143277833|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.054|TWO_SIDED|95.0|-0.03|3.25|||ANCOVA|ANCOVA of GAD7 post-intervention, with baseline as covariate, effect of group||||3.25|-0.03|0.054
71878936|NCT04272892|143277834|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.229|TWO_SIDED|95.0|-0.7|2.87|||ANCOVA|ANCOVA of GAD7 at 8 week follow up, with baseline as covariate, effect of group||||2.87|-.70|0.229
71878937|NCT04272892|143277835|SUPERIORITY||Mean Difference (Final Values)|-1.39||||0.502|TWO_SIDED|95.0|-5.51|2.73|||ANCOVA|ANCOVA of SIS index at post-intervention, with baseline as covariate, effect of group||||2.73|-5.51|0.502
71878938|NCT04272892|143277836|SUPERIORITY||Mean Difference (Final Values)|0.183||||0.924|TWO_SIDED|95.0|-3.63|4.0|||ANCOVA|ANCOVA of SIS index at 8 week follow up, with baseline as covariate, effect of group||||4.0|-3.63|0.924
71878939|NCT00943579|143277844|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||Chi-squared|||Chi-square analyses were used to assess CGI-I scores. there were no transformations.||||>.05
71878940|NCT03697720|143277852|SUPERIORITY||||||<|0.0001||||||The a priori threshold for statistical significance was .05|t-test, 2 sided|Paired t-test||Paired t-tests were used to compare worst menstrual pain rating across diary day (0-10 numeric rating scale) from baseline and at 6-8 maths followup.||||<0.0001
71878941|NCT03697720|143277853|SUPERIORITY|||||||0.119|||||||t-test, 2 sided|paired t-test||||||.119
71878942|NCT00683163|143277855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.82|TWO_SIDED|95.0|-11.5|9.2|||t-test, 2 sided|||Mean difference in percent change from baseline (Concurrent - Sequential)||9.2|-11.5|0.82
71919214|NCT03099304|143360369|SUPERIORITY||Odds Ratio (OR)|10.3||||0.0243|TWO_SIDED|95.0|1.24|487.28||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||487.28|1.24|0.0243
71919215|NCT03099304|143360369|SUPERIORITY||Odds Ratio (OR)|28.48|||<|0.0001|TWO_SIDED|95.0|3.74|1305.2||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1305.2|3.74|<0.0001
71919216|NCT03099304|143360369|SUPERIORITY||Odds Ratio (OR)|24.66||||0.0001|TWO_SIDED|95.0|3.28|1121.4||The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression|||||1121.4|3.28|0.0001
71919217|NCT03099304|143360370|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.05|0.4936
71919218|NCT03099304|143360370|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.62|0.1140
71919219|NCT03099304|143360370|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||1.00|0.0501
71919220|NCT03099304|143360370|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|exact logistic regression||||||0.58|0.1257
71878943|NCT04456764|143277856|SUPERIORITY|||||||0.55||||||Test for group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.55
71878944|NCT04456764|143277857|SUPERIORITY|||||||0.12||||||group x time interaction|Mixed Models Analysis|random agency and a random participant effect||||||0.12
71878945|NCT04456764|143277858|SUPERIORITY|||||||0.0986|||||||Mixed Models Analysis|Adjusted for clustering.||||||0.0986
71878946|NCT04456764|143277859|SUPERIORITY|||||||0.51||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.51
71878947|NCT04456764|143277860|SUPERIORITY|||||||0.04||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.04
71878948|NCT04456764|143277861|SUPERIORITY|||||||0.02||||||Group by time interaction.|Mixed Models Analysis|Adjusted for clustering.||||||0.02
71878949|NCT03496012|143277863|SUPERIORITY||Difference in Proportions|2.9|||=|0.354|TWO_SIDED|95.0|-3.1|15.0|||Fisher's Exact|||||15|-3.1|=0.354
71878950|NCT03496012|143277863|SUPERIORITY||Difference in proportions|4.6|||=|0.245|TWO_SIDED|95.0|-1.4|12.8|||Fisher's Exact|||||12.8|-1.4|=0.245
71878951|NCT03496012|143277865|SUPERIORITY||Difference in proportions|16.0|||||TWO_SIDED|95.0|5.3|32.2||||||||32.2|5.3|
71878952|NCT03496012|143277865|SUPERIORITY||Difference in proportions|12.2|||||TWO_SIDED|95.0|3.5|23.0||||||||23|3.5|
71878953|NCT03496012|143277866|SUPERIORITY||Difference in proportions|2.8|||||TWO_SIDED|95.0|-17.2|21.0||||||||21|-17.2|
71878954|NCT03496012|143277866|SUPERIORITY||Difference in proportions|15.3|||||TWO_SIDED|95.0|0.3|30.1||||||||30.1|0.3|
71878955|NCT01251653|143277918|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|81.27|STANDARD_DEVIATION|63.3||0.4815|TWO_SIDED|90.0|44.863|147.205|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.205|44.863|0.4815
71878956|NCT01251653|143277918|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|95.36|STANDARD_DEVIATION|15.4||0.0149|TWO_SIDED|90.0|84.139|108.077|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||108.077|84.139|0.0149
71878957|NCT01251653|143277918|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|88.12|STANDARD_DEVIATION|9.2||0.0208|TWO_SIDED|90.0|81.778|94.964|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.964|81.778|0.0208
71878958|NCT01251653|143277919|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|141.36|STANDARD_DEVIATION|14.7||0.8715|TWO_SIDED|90.0|115.848|172.495|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||172.495|115.848|0.8715
71878959|NCT01251653|143277919|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|77.42|STANDARD_DEVIATION|16.8||0.6805|TWO_SIDED|90.0|68.516|87.473|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||87.473|68.516|0.6805
71878960|NCT01251653|143277919|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|83.95|STANDARD_DEVIATION|14.3||0.2327|TWO_SIDED|90.0|74.794|94.217|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||94.217|74.794|0.2327
71878961|NCT01251653|143277920|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|136.11|STANDARD_DEVIATION|26.3||0.7759|TWO_SIDED|90.0|112.09|165.29|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||165.29|112.09|0.7759
71878962|NCT01251653|143277921|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|118.41|STANDARD_DEVIATION|31.6||0.3359|TWO_SIDED|90.0|94.81|147.88|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||147.88|94.81|0.3359
71878963|NCT01251653|143277924|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|93.69|STANDARD_DEVIATION|19.5||0.0349|TWO_SIDED|90.0|81.352|107.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||107.890|81.352|0.0349
71882646|NCT02706873|143284650|SUPERIORITY||Response Rate Difference|20.3|||<|0.001|TWO_SIDED|95.0|13.2|27.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||27.3|13.2|<0.001
71919221|NCT03099304|143360371|SUPERIORITY||Odds Ratio (OR)|1.19||||0.9794|TWO_SIDED|95.0|0.33|4.33|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||4.33|0.33|0.9794
71878964|NCT01251653|143277924|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|98.11|STANDARD_DEVIATION|30.4||0.0405|TWO_SIDED|90.0|81.053|118.76|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||118.760|81.053|0.0405
71878965|NCT01251653|143277925|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|90.78|STANDARD_DEVIATION|22.8||0.0728|TWO_SIDED|90.0|78.566|104.901|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||104.901|78.566|0.0728
71878966|NCT01251653|143277925|NON_INFERIORITY_OR_EQUIVALENCE|p-value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|85.74|STANDARD_DEVIATION|48.9||0.3294|TWO_SIDED|90.0|65.561|112.138|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with 'subject' as random, whereas the 'treatment' as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).|||112.138|65.561|0.3294
71878967|NCT01439282|143277928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.108||||||1-side P value was obtained|1-sample binomial test|||||||0.1080
71878968|NCT00885703|143277939|SUPERIORITY|||||||0.0012||||||Analysis did not adjust for multiple comparisons.|Chi-squared|||Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.||||0.0012
71878969|NCT00885703|143277940|SUPERIORITY|||||||0.012|||||||Fisher Exact|||Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.||||0.012
71878970|NCT00885703|143277941|SUPERIORITY|||||||0.019|||||||Kruskal-Wallis|||Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.||||0.019
71878971|NCT00885703|143277942|SUPERIORITY|||||||0.0894||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.0894
71878972|NCT00885703|143277942|SUPERIORITY|||||||0.4828||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.4828
71878973|NCT00885703|143277942|SUPERIORITY|||||||0.1766||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.||||0.1766
71878974|NCT04096274|143277965|SUPERIORITY|||||||0.014|||||||Mixed Models Analysis|||||||.014
71878975|NCT04096274|143277966|SUPERIORITY|||||||0.023|||||||Mixed Models Analysis|||||||.023
71878976|NCT04096274|143277967|SUPERIORITY|||||||0.188|||||||Mixed Models Analysis|||||||.188
71878977|NCT04096274|143277968|SUPERIORITY|||||||0.782|||||||Mixed Models Analysis|||||||.782
71878978|NCT02807480|143277969|OTHER|Correlation between conflict approach behavior and GAD-7 scores at baseline|Pearson correlation|0.23||||0.088|TWO_SIDED||||||Pearson correlation|||||||.088
71878979|NCT02807480|143277969|OTHER||Pearson correlation|-0.2||||0.134|TWO_SIDED||||||Pearson correlation|||Correlation of baseline response time during conflict with baseline GAD-7 scores.||||.134
71878980|NCT02807480|143277969|OTHER||Pearson correlation|0.12||||0.032|TWO_SIDED||||||Pearson correlation|||Correlation of baseline striatum response to points (reward) with baseline GAD-7 scores.||||.032
71878981|NCT02807480|143277969|OTHER||Pearson correlation|-0.12||||0.375|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right amygdala activity during negative images with baseline GAD7 scores||||0.375
71878982|NCT02807480|143277969|OTHER||Pearson correlation|0.06||||0.651|TWO_SIDED||||||Pearson correlation|||Correlation of baseline right dlPFC activity during conflict decision-making with baseline GAD-7 scores.||||.651
71878983|NCT02807480|143277969|OTHER|Correlation of baseline striatum response to negative pictures with baseline GAD-7 scores.|Pearson correlation|-0.35||||0.008|TWO_SIDED||||||Pearson correlation|||||||.008
71878984|NCT02807480|143277970|OTHER||Slope|-1.51||||0.007|TWO_SIDED|95.0|-2.62|-0.41||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear||Those with lower levels of baseline left amygdala response to positive picture outcomes had favorable GAD symptom improvements in BA and limited GAD symptom improvements in EXP.|Assess left amygdala response to positive picture decision outcomes as a predictor of GAD-7 symptom improvement: time x L. Amyg x treatment-arm interaction||-0.41|-2.62|.007
71878985|NCT02807480|143277970|OTHER||Slope|0.36||||0.238|TWO_SIDED|95.0|-0.24|0.97|||Regression, Linear|||Baseline approach behavior during conflict trials predicting trajectory of GAD-7 symptoms: time main effect||0.97|-0.24|0.238
71878986|NCT02807480|143277970|SUPERIORITY||Slope|-0.49||||0.262|TWO_SIDED|95.0|-1.36|0.37|||Regression, Linear|||Relationship between baseline approach behavior on conflict trials and the trajectory of GAD-7 symptoms: time x treatment interaction effect||0.37|-1.36|.262
71878987|NCT02807480|143277970|OTHER||Slope|2.37||||0.222|TWO_SIDED|95.0|-1.44|6.19|||Regression, Linear|||relationship between baseline response time on conflict trials and trajectory of GAD-7 symptoms: time main effects||6.19|-1.44|.222
71919222|NCT03099304|143360371|SUPERIORITY||Odds Ratio (OR)|1.69||||0.4893|TWO_SIDED|95.0|0.51|5.86|||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).||||5.86|0.51|0.4893
71686090|NCT03300050|142890039|OTHER||GMT Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.24|0.62|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||0.62|0.24|<0.0001
71686091|NCT03300050|142890040|OTHER||Difference|59.6||||0.0025|TWO_SIDED|95.0|23.59|81.02|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||81.02|23.59|0.0025
71686092|NCT03300050|142890040|OTHER||Difference|17.9||||0.4421|TWO_SIDED|95.0|-16.24|49.0|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||49.00|-16.24|0.4421
71686093|NCT03300050|142890040|OTHER||Difference|-41.8||||0.0461|TWO_SIDED|95.0|-68.75|-4.8|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||-4.80|-68.75|0.0461
71686094|NCT03300050|142890044|OTHER||GMT Ratio|1.71||||0.1665|TWO_SIDED|95.0|0.84|3.48|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.48|0.84|0.1665
71686095|NCT03300050|142890044|OTHER||GMT Ratio|1.1||||0.9377|TWO_SIDED|95.0|0.55|2.2|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.20|0.55|0.9377
71686096|NCT03300050|142890044|OTHER||GMT Ratio|0.64||||0.3088|TWO_SIDED|95.0|0.31|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.33|0.31|0.3088
71878988|NCT02807480|143277970|SUPERIORITY||Slope|-0.23||||0.942|TWO_SIDED|95.0|-6.48|6.02|||Regression, Linear|||Relationship between baseline average RT during conflict trials on the AAC and trajectory of GAD-7 symptoms: time x treatment interaction effect||6.02|-6.48|.942
71878989|NCT02807480|143277970|OTHER||Slope|-0.05||||0.932|TWO_SIDED|95.0|-1.2|1.1|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time main effects||1.1|-1.2|.932
71878990|NCT02807480|143277970|SUPERIORITY||Slope|-0.08||||0.922|TWO_SIDED|95.0|-1.7|1.53|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with GAD-7 trajectory: time x treatment interaction effects||1.53|-1.7|.922
71878991|NCT02807480|143277970|OTHER||Slope|0.0||||0.998|TWO_SIDED|95.0|-0.99|0.99|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time main effects||.99|-.99|.998
71878992|NCT02807480|143277970|SUPERIORITY||Slope|-0.88||||0.234|TWO_SIDED|95.0|-2.34|0.57|||Regression, Linear|||Relationship of right amygdala activity during negative images with GAD-7 trajectory: time x treatment interaction||.57|-2.34|.234
71878993|NCT02807480|143277970|OTHER||Slope|-0.03||||0.967|TWO_SIDED|95.0|-1.53|1.47|||Regression, Linear|||Relationship of right dlPFC activity during conflict decisions with GAD-7 trajectory: time main effects||1.47|-1.53|.967
71919223|NCT03099304|143360378|SUPERIORITY||Least squares mean (LSM) difference|-0.44|STANDARD_ERROR_OF_MEAN|0.16||0.0056|TWO_SIDED|95.0|-0.75|-0.13|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.13|-0.75|0.0056
71919224|NCT03099304|143360378|SUPERIORITY||LSM difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0095|TWO_SIDED|95.0|-0.7|-0.1|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.10|-0.70|0.0095
71919225|NCT03099304|143360378|SUPERIORITY||LSM difference|-0.68|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-0.99|-0.37|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.37|-0.99|<0.0001
71919226|NCT03099304|143360378|SUPERIORITY||LSM difference|-0.51|STANDARD_ERROR_OF_MEAN|0.15||0.0011|TWO_SIDED|95.0|-0.8|-0.21|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.21|-0.80|0.0011
71919227|NCT03099304|143360380|SUPERIORITY||LSM difference|-36.71|STANDARD_ERROR_OF_MEAN|10.34||0.0005|TWO_SIDED|95.0|-57.15|-16.27|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.27|-57.15|0.0005
71919228|NCT03099304|143360380|SUPERIORITY||LM difference|-35.12|STANDARD_ERROR_OF_MEAN|10.01||0.0006|TWO_SIDED|95.0|-54.91|-15.33|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-15.33|-54.91|0.0006
71919229|NCT03099304|143360380|SUPERIORITY||LSM difference|-46.02|STANDARD_ERROR_OF_MEAN|10.35|<|0.0001|TWO_SIDED|95.0|-66.47|-25.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-25.57|-66.47|<0.0001
71919230|NCT03099304|143360380|SUPERIORITY||LSM difference|-43.8|STANDARD_ERROR_OF_MEAN|9.98|<|0.0001|TWO_SIDED|95.0|-63.52|-24.07|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-24.07|-63.52|<0.0001
71878994|NCT02807480|143277970|OTHER||Slope|0.74||||0.504|TWO_SIDED|95.0|-1.43|2.91|||Regression, Linear|||Relationship of right dlPFC activity during conflict decision-making with GAD-7 trajectory: time x treatment interaction effect||2.91|-1.43|0.504
71878995|NCT02807480|143277970|OTHER||Slope|-1.68||||0.612|TWO_SIDED|95.0|-8.21|4.84|||Regression, Linear|||Change in conflict arbitration (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_Change interaction||4.84|-8.21|0.612
71878996|NCT02807480|143277970|SUPERIORITY||Slope|5.08||||0.259|TWO_SIDED|95.0|-3.76|13.92|||Regression, Linear|||change in conflict arbitration response time (AAC conflict RTpost-RTpre) predicting trajectories of GAD-7 scores over 10 sessions: RT\_Change x Time x Treatment interaction||13.92|-3.76|.259
71878997|NCT02807480|143277970|OTHER||Slope|-0.53||||0.209|TWO_SIDED|95.0|-1.35|0.3|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.30|-1.35|.209
71878998|NCT02807480|143277970|SUPERIORITY||Slope|1.53||||0.013|TWO_SIDED|95.0|0.33|2.73|||Regression, Linear|||Change in behavior (AAC conflict post-pre) in predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change x Treatment interaction||2.73|0.33|0.013
71686097|NCT03300050|142890045|OTHER||Difference|16.3||||0.4667|TWO_SIDED|95.0|-19.85|48.88|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||48.88|-19.85|0.4667
71686098|NCT03300050|142890045|OTHER||Difference|-1.8|||>|0.9999|TWO_SIDED|95.0|-34.76|32.17|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||32.17|-34.76|>0.9999
71686099|NCT03300050|142890045|OTHER||Difference|-18.1||||0.4495|TWO_SIDED|95.0|-51.15|19.37|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||19.37|-51.15|0.4495
71686100|NCT03300050|142890049|OTHER||GMT Ratio|1.61||||0.0928|TWO_SIDED|95.0|0.94|2.77|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.77|0.94|0.0928
71878999|NCT02807480|143277971|OTHER||Slope|-2.95||||0.006|TWO_SIDED|95.0|-5.06|-0.84||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of the linear trajectory of symptom change over time: time x EC interaction||-0.84|-5.06|0.006
71879000|NCT02807480|143277971|OTHER||Slope|-1.02||||0.003|TWO_SIDED|95.0|-1.68|-0.36|||Regression, Linear|||Assess avoidance behavior on conflict trials as a predictor of PROMIS Anxiety symptom improvement: time x avoidance interaction||-0.36|-1.68|0.003
71686101|NCT03300050|142890049|OTHER||GMT Ratio|1.32||||0.4198|TWO_SIDED|95.0|0.77|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.77|0.4198
71686102|NCT03300050|142890049|OTHER||GMT Ratio|0.82||||0.6754|TWO_SIDED|95.0|0.47|1.45|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.45|0.47|0.6754
71879001|NCT02807480|143277971|OTHER||Slope|-1.88||||0.007|TWO_SIDED|95.0|-2.89|-0.87||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0071.|Regression, Linear|||Assess left dlPFC response to baseline negative picture decision outcomes as a predictor of PROMIS Anxiety symptom improvement: time x L. dlPFC interaction||-0.87|-2.89|.007
71879002|NCT02807480|143277971|OTHER||Slope|1.02||||0.003|TWO_SIDED|95.0|0.36|1.68|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms||1.68|0.36|.003
71686103|NCT03300050|142890050|OTHER||Difference|19.2||||0.4515|TWO_SIDED|95.0|-17.19|50.49|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||50.49|-17.19|0.4515
71879003|NCT02807480|143277971|SUPERIORITY||Slope|-0.54||||0.258|TWO_SIDED|95.0|-1.48|0.4|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x approach behavior interaction||0.4|-1.48|.258
71879004|NCT02807480|143277971|OTHER||Slope|1.3||||0.56|TWO_SIDED|95.0|-3.08|5.69|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x approach behavior interaction||5.69|-3.08|.56
71686104|NCT03300050|142890050|OTHER||Difference|14.3||||0.4837|TWO_SIDED|95.0|-21.22|46.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||46.19|-21.22|0.4837
71686105|NCT03300050|142890050|OTHER||Difference|-4.9|||>|0.9999|TWO_SIDED|95.0|-38.8|30.46|||Fisher Exact|||Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||30.46|-38.80|>0.9999
71686106|NCT03300050|142890053|OTHER||Difference|2.93||||0.0031|TWO_SIDED|95.0|1.56|7.49|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||7.49|1.56|0.0031
71686107|NCT03300050|142890053|OTHER||Difference|1.25||||0.2048|TWO_SIDED|95.0|0.73|2.23|||Wilcoxon (Mann-Whitney)||Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||2.23|0.73|0.2048
71686108|NCT03300050|142890053|OTHER||Difference|0.43||||0.0392|TWO_SIDED|95.0|0.18|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost||1.00|0.18|0.0392
71686109|NCT03300050|142890054|OTHER||Difference|1.16||||0.8243|TWO_SIDED|95.0|0.14|4.95|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||4.95|0.14|0.8243
71686110|NCT03300050|142890054|OTHER||Difference|1.74||||0.253|TWO_SIDED|95.0|0.67|6.06|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||6.06|0.67|0.2530
71686111|NCT03300050|142890054|OTHER||Difference|1.83||||0.5654|TWO_SIDED|95.0|0.47|39.92|||Wilcoxon (Mann-Whitney)||Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.|Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost||39.92|0.47|0.5654
71686112|NCT03300050|142890058|OTHER||GMT Ratio|1.21||||0.883|TWO_SIDED|95.0|0.45|3.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.27|0.45|0.8830
71686113|NCT03300050|142890058|OTHER||GMT Ratio|0.86||||0.9238|TWO_SIDED|95.0|0.33|2.26|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.26|0.33|0.9238
71879005|NCT02807480|143277971|SUPERIORITY||Slope|-1.77||||0.629|TWO_SIDED|95.0|-8.95|5.41|||Regression, Linear|||Relationships between baseline average RT (response time) during conflict trials on the AAC and trajectory of PROMIS Anxiety symptoms: time x treatment x RT interaction||5.41|-8.95|.629
71879006|NCT02807480|143277971|OTHER||Slope|-0.21||||0.75|TWO_SIDED|95.0|-1.51|1.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS ANXIETY trajectory: time x striatum interaction effects||1.09|-1.51|0.75
71879007|NCT02807480|143277971|SUPERIORITY||Slope|1.27||||0.169|TWO_SIDED|95.0|-0.54|3.09|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Anxiety trajectory: time x treatment x striatum interaction effects||3.09|-0.54|.169
71879008|NCT02807480|143277971|OTHER||Slope|0.15||||0.792|TWO_SIDED|95.0|-1.0|1.31|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x amygdala interaction||1.31|-1.00|0.792
71879009|NCT02807480|143277971|SUPERIORITY||Slope|-0.73||||0.396|TWO_SIDED|95.0|-2.41|0.96|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Anxiety trajectory: time x treatment amygdala interaction||0.96|-2.41|.396
71686114|NCT03300050|142890058|OTHER||GMT Ratio|0.71||||0.6926|TWO_SIDED|95.0|0.26|1.97|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||1.97|0.26|0.6926
71686115|NCT03300050|142890059|OTHER||Difference|11.7||||0.7036|TWO_SIDED|95.0|-25.72|45.82|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||45.82|-25.72|0.7036
71686116|NCT03300050|142890059|OTHER||Difference|-3.8|||>|0.9999|TWO_SIDED|95.0|-37.9|31.31|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||31.31|-37.90|>0.9999
71686117|NCT03300050|142890059|OTHER||Difference|-15.5||||0.6951|TWO_SIDED|95.0|-49.56|22.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||22.79|-49.56|0.6951
71686118|NCT03300050|142890063|OTHER||GMT Ratio|0.65||||0.3203|TWO_SIDED|95.0|0.32|1.33|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.33|0.32|0.3203
71686119|NCT03300050|142890063|OTHER||GMT Ratio|0.72||||0.5009|TWO_SIDED|95.0|0.35|1.47|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||1.47|0.35|0.5009
71686120|NCT03300050|142890063|OTHER||GMT Ratio|1.1||||0.9542|TWO_SIDED|95.0|0.51|2.37|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose||2.37|0.51|0.9542
71686121|NCT03300050|142890064|OTHER||Difference|-1.7|||>|0.9999|TWO_SIDED|95.0|-30.62|23.79|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||23.79|-30.62|>0.9999
71686122|NCT03300050|142890064|OTHER||Difference|6.7|||>|0.9999|TWO_SIDED|95.0|-16.24|30.34|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||30.34|-16.24|>0.9999
71686123|NCT03300050|142890064|OTHER||Difference|8.3||||0.4615|TWO_SIDED|95.0|-19.94|36.04|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose||36.04|-19.94|0.4615
71686124|NCT03300050|142890068|OTHER||GMT Ratio|1.2||||0.9164|TWO_SIDED|95.0|0.38|3.8|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||3.80|0.38|0.9164
71686125|NCT03300050|142890068|OTHER||GMT Ratio|0.76||||0.8642|TWO_SIDED|95.0|0.21|2.79|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.79|0.21|0.8642
71686126|NCT03300050|142890068|OTHER||GMT Ratio|0.63||||0.6545|TWO_SIDED|95.0|0.18|2.27|||ANCOVA||GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.|Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose||2.27|0.18|0.6545
71686127|NCT03300050|142890069|OTHER||Difference|7.7|||>|0.9999|TWO_SIDED|95.0|-27.1|40.96|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (\>4-Fold) Rate 28 Days Post-Boost Dose||40.96|-27.10|>0.9999
71686128|NCT03300050|142890069|OTHER||Difference|30.8||||0.1045|TWO_SIDED|95.0|-1.76|58.19|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||58.19|-1.76|0.1045
71686129|NCT03300050|142890069|OTHER||Difference|23.1||||0.2292|TWO_SIDED|95.0|-8.62|50.86|||Fisher Exact|||Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose||50.86|-8.62|0.2292
71686130|NCT03517449|142890140|SUPERIORITY||Hazard Ratio (HR)|0.56|||<|0.0001|TWO_SIDED|95.0|0.47|0.66|||Log Rank||Regression, Cox method|||0.66|0.47|<0.0001
71686131|NCT03517449|142890141|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Log Rank||Regression, Cox method|||0.75|0.51|<0.0001
71686132|NCT03517449|142890142|SUPERIORITY||Difference in Percent|17.2|||<|0.0001|TWO_SIDED|95.0|11.5|22.9|||Miettinen & Nurminen method|||||22.9|11.5|<0.0001
71686133|NCT03304184|142890165|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine)|Mean Difference (Final Values)|3.0||||0.0001|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0001
71686134|NCT03304184|142890165|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in global base changes scores between the two treatment groups (Photac and Biodentine) over timepoints|Mean Difference (Final Values)|3.0||||0.0005|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0005
71686135|NCT03304184|142890166|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine).|Mean Difference (Final Values)|3.0||||0.091|TWO_SIDED|95.0||||Comparison between two groups for treatment|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0910
71686136|NCT03304184|142890166|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in 49 questions on oral health related quality of life scores between the two treatment groups (Photac and Biodentine) over time points|Mean Difference (Final Values)|3.0||||0.0262|TWO_SIDED|95.0||||Comparison between the two arms for treatment time points with analysis|ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0262
71686137|NCT03304184|142890167|EQUIVALENCE|In this analysis, the null hypothesis was that there was no significant difference in brief pain inventory scores between the two treatment groups (Photac and Biodentine) over different time points.|Mean Difference (Final Values)|3.0||||0.0289|TWO_SIDED|95.0|||||ANOVA||The estimation values were from an average of all values in each arm.|Power was limited sample size between the groups a superiority analysis was not able to be completed, so an equivalence test was used.||||.0289
71686138|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|||<|0.0001|TWO_SIDED|95.0|5.0|10.9|||Mixed Models Analysis|||||10.9|5.0|<0.0001
71686139|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.6|||<|0.0001|TWO_SIDED|95.0|10.2|15.0|||Mixed Models Analysis|||||15.0|10.2|<0.0001
71686140|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.0|||<|0.0001|TWO_SIDED|95.0|11.7|16.2|||Mixed Models Analysis|||||16.2|11.7|<0.0001
71686141|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.3|||<|0.0001|TWO_SIDED|95.0|9.9|14.7|||Mixed Models Analysis|||||14.7|9.9|<0.0001
71686142|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.0014|TWO_SIDED|95.0|-6.9|-1.8|||Mixed Models Analysis|||||-1.8|-6.9|0.0014
71686143|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.7601|TWO_SIDED|95.0|-1.5|2.1|||Mixed Models Analysis|||||2.1|-1.5|0.7601
71686144|NCT01096680|142890168|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.7||||0.0351|TWO_SIDED|95.0|0.1|3.2|||Mixed Models Analysis|||||3.2|0.1|0.0351
71686145|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1123|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.1123
71879010|NCT02807480|143277971|OTHER||Slope|-1.55||||0.009|TWO_SIDED|95.0|-2.7|-0.4|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x dlPFC interaction||-0.4|-2.7|.009
71879011|NCT02807480|143277971|SUPERIORITY||Slope|0.28||||0.724|TWO_SIDED|95.0|-1.28|1.84|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Anxiety trajectory: time x treatment dlPFC interaction||1.84|-1.28|0.724
71686146|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0002|TWO_SIDED|95.0|-1.8|-0.6|||Mixed Models Analysis|||||-0.6|-1.8|0.0002
71686147|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.0|||Mixed Models Analysis|||||-1.0|-2.2|<0.0001
71686148|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0947|TWO_SIDED|95.0|-1.1|0.1|||Mixed Models Analysis|||||0.1|-1.1|0.0947
71686149|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9393|TWO_SIDED|95.0|-0.6|0.6|||Mixed Models Analysis|||||0.6|-0.6|0.9393
71686150|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.0297|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis|||||-0.1|-1.3|0.0297
71686151|NCT01096680|142890169|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0004|TWO_SIDED|95.0|-1.7|-0.5|||Mixed Models Analysis|||||-0.5|-1.7|0.0004
71686152|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.7758|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||7:50pm||0.6|-0.5|0.7758
71686153|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1798|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||7:50pm||0.9|-0.2|0.1798
71686154|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.7|||Mixed Models Analysis|||7:50pm||0.7|-0.4|0.6090
71686155|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.1169|TWO_SIDED|95.0|-0.1|1.0|||Mixed Models Analysis|||7:50pm||1.0|-0.1|0.1169
71686156|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3028|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||7:50pm||0.3|-0.8|0.3028
71686157|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9831|TWO_SIDED|95.0|-0.5|0.5|||Mixed Models Analysis|||7:50pm||0.5|-0.5|0.9831
71686158|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2887|TWO_SIDED|95.0|-0.8|0.2|||Mixed Models Analysis|||7:50pm||0.2|-0.8|0.2887
71879012|NCT02807480|143277971|OTHER||Slope|-4.99||||0.209|TWO_SIDED|95.0|-12.79|2.8|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||2.80|-12.79|.209
71686159|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4395|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.4395
71686160|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9019|TWO_SIDED|95.0|-0.5|0.6|||Mixed Models Analysis|||8:50pm||0.6|-0.5|0.9019
71686161|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3419|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3419
71686162|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9581|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.9581
71686163|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.2572|TWO_SIDED|95.0|-0.9|0.2|||Mixed Models Analysis|||8:50pm||0.2|-0.9|0.2572
71686164|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8085|TWO_SIDED|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm||0.5|-0.6|0.8085
71686165|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3678|TWO_SIDED|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm||0.3|-0.8|0.3678
71686166|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3732|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.3732
71686167|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.4924|TWO_SIDED|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm||0.4|-0.9|0.4924
71686168|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9798|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.9798
71879013|NCT02807480|143277971|SUPERIORITY||Slope|12.68||||0.017|TWO_SIDED|95.0|2.23|23.13|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||23.13|2.23|0.017
71879014|NCT02807480|143277971|OTHER||Slope|-0.58||||0.259|TWO_SIDED|95.0|-1.59|0.43|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.43|-1.59|.259
71686169|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8557|TWO_SIDED|95.0|-0.6|0.7|||Mixed Models Analysis|||9:50pm||0.7|-0.6|0.8557
71686170|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.0998|TWO_SIDED|95.0|-1.2|0.1|||Mixed Models Analysis|||9:50pm||0.1|-1.2|0.0998
71686171|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1479|TWO_SIDED|95.0|-1.1|0.2|||Mixed Models Analysis|||9:50pm||0.2|-1.1|0.1479
71686172|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8358|TWO_SIDED|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm||0.6|-0.7|0.8358
71686173|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0199|TWO_SIDED|95.0|-1.6|-0.1|||Mixed Models Analysis|||10:50pm||-0.1|-1.6|0.0199
71686174|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.7625|TWO_SIDED|95.0|-0.9|0.6|||Mixed Models Analysis|||10:50pm||0.6|-0.9|0.7625
71686175|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.1936|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.1936
71686176|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3||||0.4534|TWO_SIDED|95.0|-0.5|1.0|||Mixed Models Analysis|||10:50pm||1.0|-0.5|0.4534
71686177|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0012|TWO_SIDED|95.0|-2.0|-0.5|||Mixed Models Analysis|||10:50pm||-0.5|-2.0|0.0012
71686178|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.2072|TWO_SIDED|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm||0.3|-1.2|0.2072
71686179|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0413|TWO_SIDED|95.0|-1.5|0.0|||Mixed Models Analysis|||10:50pm||0.0|-1.5|0.0413
71686180|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1086|TWO_SIDED|95.0|-1.5|0.1|||Mixed Models Analysis|||11:50pm||0.1|-1.5|0.1086
71686181|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.5843|TWO_SIDED|95.0|-1.0|0.6|||Mixed Models Analysis|||11:50pm||0.6|-1.0|0.5843
71686182|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0571|TWO_SIDED|95.0|-1.6|0.0|||Mixed Models Analysis|||11:50pm||0.0|-1.6|0.0571
71686183|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.3965|TWO_SIDED|95.0|-1.2|0.5|||Mixed Models Analysis|||11:50pm||0.5|-1.2|0.3965
71686184|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0009|TWO_SIDED|95.0|-2.2|-0.6|||Mixed Models Analysis|||11:50pm||-0.6|-2.2|0.0009
71686185|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0211|TWO_SIDED|95.0|-1.8|-0.1|||Mixed Models Analysis|||11:50pm||-0.1|-1.8|0.0211
71686186|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.2863|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||11:50pm||0.4|-1.2|0.2863
71686187|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0428|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||12:50am||0.0|-1.7|0.0428
71686188|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3757|TWO_SIDED|95.0|-0.5|1.2|||Mixed Models Analysis|||12:50am||1.2|-0.5|0.3757
71686189|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0002|TWO_SIDED|95.0|-2.4|-0.8|||Mixed Models Analysis|||12:50am||-0.8|-2.4|0.0002
71879015|NCT02807480|143277971|OTHER||Slope|1.07||||0.15|TWO_SIDED|95.0|-0.39|2.54|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.54|-0.39|.150
71686190|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.3535|TWO_SIDED|95.0|-1.2|0.4|||Mixed Models Analysis|||12:50am||0.4|-1.2|0.3535
71686191|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.1|||Mixed Models Analysis|||12:50am||-1.1|-2.7|<0.0001
71686192|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1131|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||12:50am||0.2|-1.5|0.1131
71686193|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0039|TWO_SIDED|95.0|-2.0|-0.4|||Mixed Models Analysis|||12:50am||-0.4|-2.0|0.0039
71686194|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.1302|TWO_SIDED|95.0|-1.5|0.2|||Mixed Models Analysis|||1:50am||0.2|-1.5|0.1302
71686195|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.6138|TWO_SIDED|95.0|-0.6|1.1|||Mixed Models Analysis|||1:50am||1.1|-0.6|0.6138
71686196|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.0008|TWO_SIDED|95.0|-2.3|-0.6|||Mixed Models Analysis|||1:50am||-0.6|-2.3|0.0008
71686197|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.1643|TWO_SIDED|95.0|-1.5|0.3|||Mixed Models Analysis|||1:50am||0.3|-1.5|0.1643
71686198|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0002|TWO_SIDED|95.0|-2.5|-0.8|||Mixed Models Analysis|||1:50am||-0.8|-2.5|0.0002
71686199|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.0782|TWO_SIDED|95.0|-1.6|0.1|||Mixed Models Analysis|||1:50am||0.1|-1.6|0.0782
71686200|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0441|TWO_SIDED|95.0|-1.7|0.0|||Mixed Models Analysis|||1:50am||0.0|-1.7|0.0441
71686201|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0193|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0193
71686202|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7071|TWO_SIDED|95.0|-1.2|0.8|||Mixed Models Analysis|||2:50am||0.8|-1.2|0.7071
71686203|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0002|TWO_SIDED|95.0|-2.9|-0.9|||Mixed Models Analysis|||2:50am||-0.9|-2.9|0.0002
71686204|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0611|TWO_SIDED|95.0|-1.9|0.0|||Mixed Models Analysis|||2:50am||0.0|-1.9|0.0611
71686205|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||2:50am||-1.2|-3.2|<0.0001
71686206|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.016|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am||-0.2|-2.2|0.0160
71686207|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.048|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||2:50am||0.0|-2.0|0.0480
71686208|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0234|TWO_SIDED|95.0|-2.2|-0.2|||Mixed Models Analysis|||3:50am||-0.2|-2.2|0.0234
71686209|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.5624|TWO_SIDED|95.0|-1.3|0.7|||Mixed Models Analysis|||3:50am||0.7|-1.3|0.5624
71686210|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||3:50am||-1.5|-3.5|<0.0001
71686211|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||3:50am||-0.6|-2.6|0.0022
71686212|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7|||<|0.0001|TWO_SIDED|95.0|-3.7|-1.6|||Mixed Models Analysis|||3:50am||-1.6|-3.7|<0.0001
71686213|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0008|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||3:50am||-0.8|-2.8|0.0008
71686214|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.0883|TWO_SIDED|95.0|-1.9|0.1|||Mixed Models Analysis|||3:50am||0.1|-1.9|0.0883
71686215|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3093|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||4:50am||0.5|-1.5|0.3093
71686216|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.8871|TWO_SIDED|95.0|-0.9|1.1|||Mixed Models Analysis|||4:50am||1.1|-0.9|0.8871
71686217|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|||<|0.0001|TWO_SIDED|95.0|-3.2|-1.2|||Mixed Models Analysis|||4:50am||-1.2|-3.2|<0.0001
71686218|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0022|TWO_SIDED|95.0|-2.6|-0.6|||Mixed Models Analysis|||4:50am||-0.6|-2.6|0.0022
71686219|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.4|-1.4|||Mixed Models Analysis|||4:50am||-1.4|-3.4|<0.0001
71686220|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.0006|TWO_SIDED|95.0|-2.8|-0.8|||Mixed Models Analysis|||4:50am||-0.8|-2.8|0.0006
71686221|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2462|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||4:50am||0.4|-1.6|0.2462
71686222|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.4427|TWO_SIDED|95.0|-1.4|0.6|||Mixed Models Analysis|||5:50am||0.6|-1.4|0.4427
71686223|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.4405|TWO_SIDED|95.0|-0.6|1.4|||Mixed Models Analysis|||5:50am||1.4|-0.6|0.4405
71686224|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0003|TWO_SIDED|95.0|-3.0|-0.9|||Mixed Models Analysis|||5:50am||-0.9|-3.0|0.0003
71686225|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0279|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||5:50am||-0.1|-2.2|0.0279
71686226|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.5|-1.5|||Mixed Models Analysis|||5:50am||-1.5|-3.5|<0.0001
71686227|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7||||0.0015|TWO_SIDED|95.0|-2.7|-0.7|||Mixed Models Analysis|||5:50am||-0.7|-2.7|0.0015
71686228|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1246|TWO_SIDED|95.0|-1.8|0.2|||Mixed Models Analysis|||5:50am||0.2|-1.8|0.1246
71686229|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3067|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||6:50am||0.5|-1.6|0.3067
71686230|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.894|TWO_SIDED|95.0|-1.0|1.1|||Mixed Models Analysis|||6:50am||1.1|-1.0|0.8940
71686231|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0034|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||6:50am||-0.5|-2.7|0.0034
71686232|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0708|TWO_SIDED|95.0|-2.0|0.1|||Mixed Models Analysis|||6:50am||0.1|-2.0|0.0708
71686233|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||6:50am||-1.4|-3.6|<0.0001
71879016|NCT02807480|143277972|OTHER||Slope|-3.52||||0.001|TWO_SIDED|95.0|-5.57|-1.47||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Assess emotional conflict, a computational parameter reflecting avoidance relative to reward value, as a predictor of PROMIS Depression scores. Time x EC interaction.||-1.47|-5.57|0.001
71879017|NCT02807480|143277972|OTHER||Slope|-1.93|||<|0.001|TWO_SIDED|95.0|-2.91|-0.95||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Baseline left dlPFC response to negative pictures as a predictor of PROMIS depression symptom improvement: time x L. dlFPC interaction.||-0.95|-2.91|<.001
71686234|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0006|TWO_SIDED|95.0|-2.9|-0.8|||Mixed Models Analysis|||6:50am||-0.8|-2.9|0.0006
71879018|NCT02807480|143277972|OTHER||Slope|-2.02||||0.036|TWO_SIDED|95.0|-3.9|-0.13||Threshold for statistical significance is 0.05.|Regression, Linear|||Baseline striatum response to monetary outcomes as a predictor of improvement in depressive symptoms: time x treatment x striatum interaction.||-0.13|-3.9|.036
71686235|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.2476|TWO_SIDED|95.0|-1.7|0.4|||Mixed Models Analysis|||6:50am||0.4|-1.7|0.2476
71686236|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.231|TWO_SIDED|95.0|-1.8|0.4|||Mixed Models Analysis|||7:50am||0.4|-1.8|0.2310
71686237|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.8369|TWO_SIDED|95.0|-1.2|1.0|||Mixed Models Analysis|||7:50am||1.0|-1.2|0.8369
71686238|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0035|TWO_SIDED|95.0|-2.7|-0.5|||Mixed Models Analysis|||7:50am||-0.5|-2.7|0.0035
71686239|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0498|TWO_SIDED|95.0|-2.2|0.0|||Mixed Models Analysis|||7:50am||0.0|-2.2|0.0498
71686240|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5|||<|0.0001|TWO_SIDED|95.0|-3.6|-1.4|||Mixed Models Analysis|||7:50am||-1.4|-3.6|<0.0001
71686241|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9||||0.0007|TWO_SIDED|95.0|-3.0|-0.8|||Mixed Models Analysis|||7:50am||-0.8|-3.0|0.0007
71686242|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5||||0.3198|TWO_SIDED|95.0|-1.6|0.5|||Mixed Models Analysis|||7:50am||0.5|-1.6|0.3198
71686243|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.375|TWO_SIDED|95.0|-0.6|1.7|||Mixed Models Analysis|||8:50am||1.7|-0.6|0.3750
71686244|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7978|TWO_SIDED|95.0|-1.3|1.0|||Mixed Models Analysis|||8:50am||1.0|-1.3|0.7978
71686245|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.5197|TWO_SIDED|95.0|-1.5|0.8|||Mixed Models Analysis|||8:50am||0.8|-1.5|0.5197
71686246|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0751|TWO_SIDED|95.0|-2.2|0.1|||Mixed Models Analysis|||8:50am||0.1|-2.2|0.0751
71686247|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.1079|TWO_SIDED|95.0|-2.1|0.2|||Mixed Models Analysis|||8:50am||0.2|-2.1|0.1079
71686248|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.0065|TWO_SIDED|95.0|-2.8|-0.5|||Mixed Models Analysis|||8:50am||-0.5|-2.8|0.0065
71686249|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.2529|TWO_SIDED|95.0|-0.5|1.8|||Mixed Models Analysis|||8:50am||1.8|-0.5|0.2529
71686250|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.6364|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6364
71686251|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9417|TWO_SIDED|95.0|-1.1|1.0|||Mixed Models Analysis|||9:50am||1.0|-1.1|0.9417
71686252|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.02|TWO_SIDED|95.0|-2.3|-0.2|||Mixed Models Analysis|||9:50am||-0.2|-2.3|0.0200
71686253|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0527|TWO_SIDED|95.0|-2.1|0.0|||Mixed Models Analysis|||9:50am||0.0|-2.1|0.0527
71686254|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0107|TWO_SIDED|95.0|-2.5|-0.3|||Mixed Models Analysis|||9:50am||-0.3|-2.5|0.0107
71686255|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0303|TWO_SIDED|95.0|-2.2|-0.1|||Mixed Models Analysis|||9:50am||-0.1|-2.2|0.0303
71686256|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.6889|TWO_SIDED|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am||0.8|-1.3|0.6889
71686257|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9552|TWO_SIDED|95.0|-1.2|1.1|||Mixed Models Analysis|||10:50am||1.1|-1.2|0.9552
71686258|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.7558|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||10:50am||1.3|-1.0|0.7558
71686259|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8||||0.1824|TWO_SIDED|95.0|-1.9|0.4|||Mixed Models Analysis|||10:50am||0.4|-1.9|0.1824
71686260|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.3323|TWO_SIDED|95.0|-1.7|0.6|||Mixed Models Analysis|||10:50am||0.6|-1.7|0.3323
71686261|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0413|TWO_SIDED|95.0|-2.4|0.0|||Mixed Models Analysis|||10:50am||0.0|-2.4|0.0413
71686262|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.0925|TWO_SIDED|95.0|-2.2|0.2|||Mixed Models Analysis|||10:50am||0.2|-2.2|0.0925
71686263|NCT01096680|142890170|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.7133|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||10:50am||0.9|-1.4|0.7133
71879019|NCT02807480|143277972|OTHER||Slope|-1.21|||<|0.001|TWO_SIDED|95.0|-1.85|-0.58||The a priori threshold for statistical significance after Bonferroni correction for multiple comparisons was p\<.0125.|Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x approach behavior interaction||-0.58|-1.85|<.001
71879020|NCT02807480|143277972|SUPERIORITY||Slope|-0.91||||0.049|TWO_SIDED|95.0|-1.81|0.0|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x approach behavior interaction||0.00|-1.81|.049
71879021|NCT02807480|143277972|OTHER||Slope|0.6||||0.778|TWO_SIDED|95.0|-3.6|4.81|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x RT interaction||4.81|-3.6|.778
71879022|NCT02807480|143277972|SUPERIORITY||Slope|1.38||||0.696|TWO_SIDED|95.0|-5.56|8.31|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PROMIS Depression symptoms: time x treatment x RT interaction||8.31|-5.56|.696
71686264|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
71686265|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-35.4|||<|0.0001|TWO_SIDED|95.0|-45.5|-25.4|||Mixed Models Analysis|||||-25.4|-45.5|<0.0001
71686266|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.7|||<|0.0001|TWO_SIDED|95.0|-36.7|-16.6|||Mixed Models Analysis|||||-16.6|-36.7|<0.0001
71686267|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-36.6|-16.5|||Mixed Models Analysis|||||-16.5|-36.6|<0.0001
71686268|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9945|TWO_SIDED|95.0|-10.1|10.0|||Mixed Models Analysis|||||10.0|-10.1|0.9945
71686269|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9||||0.0814|TWO_SIDED|95.0|-18.9|1.1|||Mixed Models Analysis|||||1.1|-18.9|0.0814
71686270|NCT01096680|142890171|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.9743|TWO_SIDED|95.0|-10.2|9.9|||Mixed Models Analysis|||||9.9|-10.2|0.9743
71686271|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6||||0.0544|TWO_SIDED|95.0|-19.4|0.2|||Mixed Models Analysis|||9:15pm||0.2|-19.4|0.0544
71686272|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8||||0.441|TWO_SIDED|95.0|-13.6|6.0|||Mixed Models Analysis|||9:15pm||6.0|-13.6|0.4410
71686273|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1||||0.1046|TWO_SIDED|95.0|-17.9|1.7|||Mixed Models Analysis|||9:15pm||1.7|-17.9|0.1046
71686274|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.6467|TWO_SIDED|95.0|-12.0|7.5|||Mixed Models Analysis|||9:15pm||7.5|-12.0|0.6467
71686275|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4||||0.1971|TWO_SIDED|95.0|-16.2|3.4|||Mixed Models Analysis|||9:15pm||3.4|-16.2|0.1971
71686276|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.9052|TWO_SIDED|95.0|-10.4|9.2|||Mixed Models Analysis|||9:15pm||9.2|-10.4|0.9052
71686277|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.242|TWO_SIDED|95.0|-15.6|4.0|||Mixed Models Analysis|||9:15pm||4.0|-15.6|0.2420
71686278|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.7||||0.0001|TWO_SIDED|95.0|-25.1|-8.3|||Mixed Models Analysis|||11:15pm||-8.3|-25.1|0.0001
71686279|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.3||||0.4321|TWO_SIDED|95.0|-5.0|11.6|||Mixed Models Analysis|||11:15pm||11.6|-5.0|0.4321
71686280|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.4|||<|0.0001|TWO_SIDED|95.0|-26.7|-10.1|||Mixed Models Analysis|||11:15pm||-10.1|-26.7|<0.0001
71686281|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.6999|TWO_SIDED|95.0|-6.7|9.9|||Mixed Models Analysis|||11:15pm||9.9|-6.7|0.6999
71686282|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.1|||<|0.0001|TWO_SIDED|95.0|-26.4|-9.8|||Mixed Models Analysis|||11:15pm||-9.8|-26.4|<0.0001
71686283|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.9||||0.6566|TWO_SIDED|95.0|-6.4|10.2|||Mixed Models Analysis|||11:15pm||10.2|-6.4|0.6566
71686284|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.3|-11.7|||Mixed Models Analysis|||11:15pm||-11.7|-28.3|<0.0001
71686285|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.2|||<|0.0001|TWO_SIDED|95.0|-36.1|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.1|<0.0001
71686286|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7824|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7824
71686287|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.1|||<|0.0001|TWO_SIDED|95.0|-36.0|-14.3|||Mixed Models Analysis|||1:15am||-14.3|-36.0|<0.0001
71686288|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.5||||0.7867|TWO_SIDED|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am||9.4|-12.4|0.7867
71686289|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.4|-15.6|||Mixed Models Analysis|||1:15am||-15.6|-37.4|<0.0001
71686290|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.6029|TWO_SIDED|95.0|-13.7|8.0|||Mixed Models Analysis|||1:15am||8.0|-13.7|0.6029
71686291|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.5|-12.8|||Mixed Models Analysis|||1:15am||-12.8|-34.5|<0.0001
71686292|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.1|||<|0.0001|TWO_SIDED|95.0|-50.1|-24.1|||Mixed Models Analysis|||3:15am||-24.1|-50.1|<0.0001
71686293|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.8684|TWO_SIDED|95.0|-11.9|14.1|||Mixed Models Analysis|||3:15am||14.1|-11.9|0.8684
71686294|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.3|||<|0.0001|TWO_SIDED|95.0|-66.3|-40.3|||Mixed Models Analysis|||3:15am||-40.3|-66.3|<0.0001
71686295|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.1||||0.0228|TWO_SIDED|95.0|-28.1|-2.1|||Mixed Models Analysis|||3:15am||-2.1|-28.1|0.0228
71686296|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-40.0|||<|0.0001|TWO_SIDED|95.0|-53.0|-27.0|||Mixed Models Analysis|||3:15am||-27.0|-53.0|<0.0001
71686297|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7852|TWO_SIDED|95.0|-14.8|11.2|||Mixed Models Analysis|||3:15am||11.2|-14.8|0.7852
71686298|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.2|-25.2|||Mixed Models Analysis|||3:15am||-25.2|-51.2|<0.0001
71686299|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-38.2|||<|0.0001|TWO_SIDED|95.0|-51.3|-25.1|||Mixed Models Analysis|||5:15am||-25.1|-51.3|<0.0001
71686300|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.9||||0.5528|TWO_SIDED|95.0|-9.1|17.0|||Mixed Models Analysis|||5:15am||17.0|-9.1|0.5528
71686301|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-53.9|||<|0.0001|TWO_SIDED|95.0|-67.0|-40.9|||Mixed Models Analysis|||5:15am||-40.9|-67.0|<0.0001
71686302|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.8||||0.0747|TWO_SIDED|95.0|-24.9|1.2|||Mixed Models Analysis|||5:15am||1.2|-24.9|0.0747
71686303|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-49.2|||<|0.0001|TWO_SIDED|95.0|-62.2|-36.1|||Mixed Models Analysis|||5:15am||-36.1|-62.2|<0.0001
71686304|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1||||0.2868|TWO_SIDED|95.0|-20.1|6.0|||Mixed Models Analysis|||5:15am||6.0|-20.1|0.2868
71686305|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-42.1|||<|0.0001|TWO_SIDED|95.0|-55.2|-29.1|||Mixed Models Analysis|||5:15am||-29.1|-55.2|<0.0001
71686306|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-37.6||||0.0007|TWO_SIDED|95.0|-59.1|-16.2|||Mixed Models Analysis|||7:15am||-16.2|-59.1|0.0007
71686307|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.9089|TWO_SIDED|95.0|-22.7|20.2|||Mixed Models Analysis|||7:15am||20.2|-22.7|0.9089
71686308|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-52.9|||<|0.0001|TWO_SIDED|95.0|-74.3|-31.4|||Mixed Models Analysis|||7:15am||-31.4|-74.3|<0.0001
71686309|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5||||0.1307|TWO_SIDED|95.0|-37.9|5.0|||Mixed Models Analysis|||7:15am||5.0|-37.9|0.1307
71686310|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.3||||0.0011|TWO_SIDED|95.0|-57.7|-14.8|||Mixed Models Analysis|||7:15am||-14.8|-57.7|0.0011
71686311|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.9903|TWO_SIDED|95.0|-21.3|21.6|||Mixed Models Analysis|||7:15am||21.6|-21.3|0.9903
71686312|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.4||||0.001|TWO_SIDED|95.0|-57.8|-14.9|||Mixed Models Analysis|||7:15am||-14.9|-57.8|0.0010
71686313|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.4||||0.1655|TWO_SIDED|95.0|-51.7|9.0|||Mixed Models Analysis|||9:15am||9.0|-51.7|0.1655
71686314|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.8975|TWO_SIDED|95.0|-32.4|28.5|||Mixed Models Analysis|||9:15am||28.5|-32.4|0.8975
71686315|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-36.2||||0.0199|TWO_SIDED|95.0|-66.5|-5.8|||Mixed Models Analysis|||9:15am||-5.8|-66.5|0.0199
71686316|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8||||0.2785|TWO_SIDED|95.0|-47.2|13.7|||Mixed Models Analysis|||9:15am||13.7|-47.2|0.2785
71686317|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3||||0.5048|TWO_SIDED|95.0|-40.6|20.1|||Mixed Models Analysis|||9:15am||20.1|-40.6|0.5048
71686318|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1||||0.5533|TWO_SIDED|95.0|-21.3|39.6|||Mixed Models Analysis|||9:15am||39.6|-21.3|0.5533
71686319|NCT01096680|142890172|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.4||||0.2098|TWO_SIDED|95.0|-49.9|11.1|||Mixed Models Analysis|||9:15am||11.1|-49.9|0.2098
71686320|NCT01578499|142890178|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|42.2|||<|0.001|TWO_SIDED|95.0|27.5|56.8||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.||56.8|27.5|<0.001
71686321|NCT01578499|142890179|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|15.6||||0.0002|TWO_SIDED|95.0|-2.5|33.0||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||||33.0|-2.5|0.0002
71686322|NCT01578499|142890180|OTHER||Hazard Ratio (HR)|0.378|||<|0.001|TWO_SIDED|95.0|0.247|0.577|||Log Rank||||Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.|0.577|0.247|<0.001
71686323|NCT01578499|142890181|SUPERIORITY_OR_OTHER_LEGACY||Estimate of difference|-19.0|||<|0.001|TWO_SIDED|95.0|-26.7|-11.4|||ANCOVA|||P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.||-11.4|-26.7|<0.001
71686324|NCT01945294|142890205|SUPERIORITY_OR_OTHER||Difference in SVR12 percentage|-11.4|||||TWO_SIDED|95.0|-23.2|0.4||||||||0.4|-23.2|
71686325|NCT01156051|142890213|SUPERIORITY_OR_OTHER|||||||0.005|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.005
71686326|NCT01156051|142890214|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||Null hypothesis: no difference in ADHD Rating Scales - IV total scores from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||<0.001
71919231|NCT03099304|143360387|SUPERIORITY||LSM difference|-2.84|STANDARD_ERROR_OF_MEAN|1.32||0.0326|TWO_SIDED|95.0|-5.44|-0.24|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.24|-5.44|0.0326
71919232|NCT03099304|143360387|SUPERIORITY||LSM difference|-2.74|STANDARD_ERROR_OF_MEAN|1.28||0.0333|TWO_SIDED|95.0|-5.26|-0.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-0.22|-5.26|0.0333
71919233|NCT03099304|143360387|SUPERIORITY||LSM difference|-5.08|STANDARD_ERROR_OF_MEAN|1.31||0.0002|TWO_SIDED|95.0|-7.68|-2.48|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-2.48|-7.68|0.0002
71919234|NCT03099304|143360387|SUPERIORITY||LSM difference|-4.08|STANDARD_ERROR_OF_MEAN|1.27||0.0016|TWO_SIDED|95.0|-6.59|-1.57|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-1.57|-6.59|0.0016
71919235|NCT03099304|143360389|SUPERIORITY||LSM difference|-23.53|STANDARD_ERROR_OF_MEAN|6.99||0.001|TWO_SIDED|95.0|-37.35|-9.71|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-9.71|-37.35|0.0010
71686327|NCT01156051|142890215|SUPERIORITY_OR_OTHER|||||||0.392|||||||ANOVA|||Null hypothesis: no difference in latency to persistent sleep (LPS) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.392
71686328|NCT01156051|142890216|SUPERIORITY_OR_OTHER|||||||0.059|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.||||0.059
71686329|NCT02620384|142890226|SUPERIORITY||Mean Difference (Final Values)|2439.511|STANDARD_ERROR_OF_MEAN|646.2707|<|0.0001|TWO_SIDED|95.0|1160.8485|3718.1734|||t-test, 2 sided|||||3718.1734|1160.8485|<0.0001
71686330|NCT02620384|142890227|SUPERIORITY||Mean Difference (Final Values)|-2249.3294|STANDARD_ERROR_OF_MEAN|608.2782|<|0.0001|TWO_SIDED|95.0|-3454.4999|-1044.1589|||t-test, 2 sided|||||-1044.1589|-3454.4999|<0.0001
71686331|NCT02620384|142890228|SUPERIORITY||Mean Difference (Final Values)|-2.717121|STANDARD_ERROR_OF_MEAN|0.586647|<|0.0001|TWO_SIDED|95.0|-3.8637732|-1.54651|||t-test, 2 sided|||||-1.546510|-3.8637732|<0.0001
71686332|NCT02620384|142890229|SUPERIORITY||Mean Difference (Final Values)|-0.6955|STANDARD_ERROR_OF_MEAN|0.2806||0.014|TWO_SIDED|95.0|-1.2506|-0.1403||Represents BORG\_48\_hours|t-test, 2 sided||Method of estimation is for 48 hour measure.|||-.1403|-1.2506|.014
71686333|NCT02620384|142890230|SUPERIORITY||Mean Difference (Final Values)|3.6903|STANDARD_ERROR_OF_MEAN|72.4074||0.959|TWO_SIDED|95.0|-1395694.0|147.1545|||t-test, 2 sided|||||147.1545|-1395694|.959
71686334|NCT02620384|142890231|SUPERIORITY|||||||0.144|||||||Chi-squared|||||||.144
71686335|NCT02620384|142890232|SUPERIORITY|||||||0.171|||||||Chi-squared|||||||.171
71686336|NCT02620384|142890233|SUPERIORITY||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.734||0.885|TWO_SIDED|95.0|-1.346|1.558|||t-test, 2 sided|||||1.558|-1.346|.885
71686337|NCT02620384|142890234|SUPERIORITY|||||||0.804|||||||Chi-squared|||||||.804
71686338|NCT02620384|142890235|SUPERIORITY|||||||0.403|||||||Chi-squared|||||||.403
71686339|NCT02620384|142890236|SUPERIORITY|||||||0.08|||||||Chi-squared|||||||.080
71686340|NCT02620384|142890237|SUPERIORITY|||||||0.559|||||||Chi-squared|||||||.559
71686341|NCT01483599|142890254|SUPERIORITY_OR_OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (\<=) 90 kilogram (kg), greater than (\>) 90 kg).||||0.002
71686342|NCT01483599|142890254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71919236|NCT03099304|143360389|SUPERIORITY||LSM difference|-18.47|STANDARD_ERROR_OF_MEAN|6.77||0.0072|TWO_SIDED|95.0|-31.86|-5.08|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-5.08|-31.86|0.0072
71879023|NCT02807480|143277972|OTHER||Slope|0.44||||0.503|TWO_SIDED|95.0|-0.84|1.71|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PROMIS Depression trajectory: time x striatum interaction effects||1.71|-0.84|.503
71879024|NCT02807480|143277972|OTHER||Slope|-0.9||||0.114|TWO_SIDED|95.0|-2.02|0.22|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x amygdala interaction||.22|-2.02|.114
71879025|NCT02807480|143277972|SUPERIORITY||Slope|0.48||||0.561|TWO_SIDED|95.0|-1.15|2.11|||Regression, Linear|||Relationship of right amygdala activity during negative images with PROMIS Depression trajectory: time x treatment amygdala interaction||2.11|-1.15|.561
71879026|NCT02807480|143277972|OTHER||Slope|-1.54||||0.007|TWO_SIDED|95.0|-2.66|-0.42|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x dlPFC interaction||-0.42|-2.66|.007
71879027|NCT02807480|143277972|SUPERIORITY||Slope|0.65||||0.403|TWO_SIDED|95.0|-0.87|2.17|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PROMIS Depression trajectory: time x treatment dlPFC interaction||2.17|-0.87|0.403
71879028|NCT02807480|143277972|OTHER||Slope|-1.51||||0.681|TWO_SIDED|95.0|-8.76|5.73|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x RT\_change interaction||5.73|-8.76|0.681
71879029|NCT02807480|143277972|SUPERIORITY||Slope|5.61||||0.264|TWO_SIDED|95.0|-4.24|15.46|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.46|-4.24|.264
71879030|NCT02807480|143277972|OTHER||Slope|-0.43||||0.367|TWO_SIDED|95.0|-1.38|0.51|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Behavior\_change interaction||0.51|-1.38|.367
71879031|NCT02807480|143277972|OTHER||Slope|0.88||||0.211|TWO_SIDED|95.0|-0.5|2.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of GAD-7 scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||2.25|-0.50|.211
71879032|NCT02807480|143277973|OTHER||Slope|0.74||||0.028|TWO_SIDED|95.0|0.08|1.41|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS score: time x approach behavior interaction||1.41|0.08|0.028
71879033|NCT02807480|143277973|SUPERIORITY||Slope|-0.55||||0.251|TWO_SIDED|95.0|-1.49|0.39|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x approach behavior interaction||0.39|-1.49|0.251
71879034|NCT02807480|143277973|OTHER||Slope|-0.26||||0.902|TWO_SIDED|95.0|-4.49|3.96|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x RT interaction||3.96|-4.49|0.902
71879035|NCT02807480|143277973|SUPERIORITY||Slope|2.23||||0.519|TWO_SIDED|95.0|-4.55|9.01|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of SDS symptoms: time x treatment x RT interaction||9.01|-4.55|.519
71879036|NCT02807480|143277973|OTHER||Slope|-0.64||||0.326|TWO_SIDED|95.0|-1.92|0.64|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x striatum interaction effects||0.64|-1.92|.326
71879037|NCT02807480|143277973|SUPERIORITY||Slope|1.26||||0.168|TWO_SIDED|95.0|-0.53|3.05|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with SDS trajectory: time x treatment x striatum interaction effects||3.05|-0.53|.168
71879038|NCT02807480|143277973|OTHER||Slope|-0.5||||0.248|TWO_SIDED|95.0|-1.34|0.35|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x amygdala interaction||0.35|-1.34|.248
71879039|NCT02807480|143277973|SUPERIORITY||Slope|0.3||||0.603|TWO_SIDED|95.0|-0.84|1.44|||Regression, Linear|||Relationship of right amygdala activity during negative images with SDS trajectory: time x treatment amygdala interaction||1.44|-0.84|0.603
71879040|NCT02807480|143277973|OTHER||Slope|-0.85||||0.107|TWO_SIDED|95.0|-1.89|0.18|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x dlPFC interaction||0.18|-1.89|.107
71879041|NCT02807480|143277973|SUPERIORITY||Slope|0.16||||0.846|TWO_SIDED|95.0|-1.47|1.8|||Regression, Linear|||Relationship of right dlPFC activity during negative images with SDS trajectory: time x treatment x dlPFC interaction||1.80|-1.47|0.846
71879042|NCT02807480|143277973|OTHER||Slope|-2.26||||0.561|TWO_SIDED|95.0|-9.89|5.37|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x RT\_change interaction||5.37|-9.89|.561
71686343|NCT01483599|142890254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879043|NCT02807480|143277973|SUPERIORITY||Slope|5.45||||0.297|TWO_SIDED|95.0|-4.8|15.7|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x RT\_change interaction||15.70|-4.80|.297
71879044|NCT02807480|143277973|OTHER||Slope|-0.18||||0.712|TWO_SIDED|95.0|-1.15|0.79|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS cores over the 10 sessions: Time x Behavior\_change interaction||0.79|-1.15|.712
71879045|NCT02807480|143277973|SUPERIORITY||Slope|0.56||||0.431|TWO_SIDED|95.0|-0.84|1.97|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of SDS scores over the 10 sessions: Time x Treatment x Behavior\_change interaction||1.97|-0.84|0.431
71879046|NCT02807480|143277974|OTHER||Slope|-6.42||||0.276|TWO_SIDED|95.0|-18.15|5.3|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: approach behavior main effect||5.30|-18.15|.276
71879047|NCT02807480|143277974|SUPERIORITY||Slope|5.69||||0.52|TWO_SIDED|95.0|-12.12|23.5|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment PSWQ score: treatment x approach behavior interaction||23.50|-12.12|.520
71879048|NCT02807480|143277974|OTHER||Slope|-50.0||||0.199|TWO_SIDED|95.0|-127.65|27.65|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: RT main effect||27.65|-127.65|.199
71879049|NCT02807480|143277974|SUPERIORITY||Slope|93.87||||0.191|TWO_SIDED|95.0|-4.14|236.88|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and trajectory of PSWQ score: treatment x RT interaction||236.88|-4.14|.191
71879050|NCT02807480|143277974|OTHER||Slope|27.35||||0.021|TWO_SIDED|95.0|4.45|50.26|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ trajectory: striatum main effect||50.26|4.45|0.021
71879051|NCT02807480|143277974|SUPERIORITY||Slope|-5.47||||0.734|TWO_SIDED|95.0|-37.94|27.0|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with PSWQ post-treatment: treatment x striatum interaction effects||27.00|-37.94|.734
71879052|NCT02807480|143277974|OTHER||Slope|-9.79||||0.231|TWO_SIDED|95.0|-26.11|6.53|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: amygdala main effect||6.53|-26.11|.231
71879053|NCT02807480|143277974|SUPERIORITY||Slope|8.55||||0.602|TWO_SIDED|95.0|-24.48|41.58|||Regression, Linear|||Relationship of right amygdala activity during negative images with PSWQ post-treatment: treatment amygdala interaction||41.58|-24.48|.602
71879054|NCT02807480|143277974|OTHER||Slope|-19.29||||0.369|TWO_SIDED|95.0|-62.07|23.68|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: dlPFC main effect||23.68|-62.07|.369
71879055|NCT02807480|143277974|SUPERIORITY||Slope|9.12||||0.684|TWO_SIDED|95.0|-36.05|54.29|||Regression, Linear|||Relationship of right dlPFC activity during negative images with PSWQ post-treatment: treatment x dlPFC interaction||54.29|-36.05|.684
71879056|NCT02807480|143277974|OTHER||Slope|9.6||||0.487|TWO_SIDED|95.0|-18.39|37.59|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ cores over the 10 sessions: Behavior\_change main effect||37.59|-18.39|.487
71879057|NCT02807480|143277974|SUPERIORITY||Slope|-46.34||||0.033|TWO_SIDED|95.0|-88.5|-4.18|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x Behavior\_change interaction||-4.18|-88.5|.033
71879058|NCT02807480|143277974|OTHER||Slope|39.53||||0.546|TWO_SIDED|95.0|-94.2|173.85|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: RT\_change main effect||173.85|-94.2|.546
71879059|NCT02807480|143277974|SUPERIORITY||Slope|-89.96||||0.443|TWO_SIDED|95.0|-327.39|147.67|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of PSWQ scores over the 10 sessions: Treatment x RT\_change interaction||147.67|-327.39|.443
71879060|NCT02807480|143277975|OTHER||Slope|-1.01||||0.357|TWO_SIDED|95.0|-3.22|1.19|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: approach behavior main effect||1.19|-3.22|.357
71879061|NCT02807480|143277975|SUPERIORITY||Slope|0.37||||0.812|TWO_SIDED|95.0|-2.74|3.47|||Regression, Linear|||Relationships between baseline average approach behavior during conflict trials on the AAC and post-treatment BDI-II score: treatment x approach behavior interaction||3.47|-2.74|.812
71879062|NCT02807480|143277975|OTHER||Slope|2.01||||0.826|TWO_SIDED|95.0|-16.42|20.45|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: RT main effect||20.45|-16.42|.826
71879063|NCT02807480|143277975|SUPERIORITY||Slope|-2.89||||0.838|TWO_SIDED|95.0|-31.42|25.64|||Regression, Linear|||Relationships between baseline average RT during conflict trials on the AAC and post-treatment BDI-II score: treatment x RT interaction||25.64|-31.42|.838
71879064|NCT02807480|143277975|OTHER||Slope|-0.68||||0.776|TWO_SIDED|95.0|-5.51|4.14|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: striatum main effect||4.14|-5.51|.776
71879065|NCT02807480|143277975|SUPERIORITY||Slope|-0.69||||0.844|TWO_SIDED|95.0|-7.79|6.4|||Regression, Linear|||Relationship of striatum activity during points outcomes (reward) with BDI-II post-treatment: treatment x striatum interaction effects||6.40|-7.79|.844
71879066|NCT02807480|143277975|OTHER||Slope|0.88||||0.719|TWO_SIDED|95.0|-4.03|5.79|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: amygdala main effect||5.79|-4.03|.719
71879067|NCT02807480|143277975|SUPERIORITY||Slope|-2.33||||0.464|TWO_SIDED|95.0|-8.74|4.07|||Regression, Linear|||Relationship of right amygdala activity during negative images with BDI-II post-treatment: treatment x amygdala interaction||4.07|-8.74|.464
71879068|NCT02807480|143277975|OTHER||Slope|5.91||||0.135|TWO_SIDED|95.0|-1.93|13.75|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: dlPFC main effect||13.75|-1.93|.135
71879069|NCT02807480|143277975|SUPERIORITY||Slope|-6.09||||0.158|TWO_SIDED|95.0|-14.65|2.47|||Regression, Linear|||Relationship of right dlPFC activity during negative images with BDI-II post-treatment: treatment x dlPFC interaction||2.47|-14.65|.158
71879070|NCT02807480|143277975|OTHER||Slope|1.16||||0.69|TWO_SIDED|95.0|-4.78|7.11|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II cores over the 10 sessions: Behavior\_change main effect||7.11|-4.78|.690
71879071|NCT02807480|143277975|SUPERIORITY||Slope|-1.37||||0.715|TWO_SIDED|95.0|-8.99|6.25|||Regression, Linear|||Change in behavior (AAC conflict post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x Behavior\_change interaction||6.25|-8.99|.715
71879072|NCT02807480|143277975|OTHER||Slope|5.14||||0.74|TWO_SIDED|95.0|-26.38|36.65|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: RT\_change main effect||36.65|-26.38|.740
71879073|NCT02807480|143277975|SUPERIORITY||Slope|-0.98||||0.966|TWO_SIDED|95.0|-48.1|46.14|||Regression, Linear|||Change in conflict arbitration response time (AAC conflict RT post-pre) predicting trajectories of BDI-II scores over the 10 sessions: Treatment x RT\_change interaction||46.14|-48.10|.966
71879074|NCT01901575|143278018|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.65|STANDARD_ERROR_OF_MEAN|0.75||0.05|TWO_SIDED|0.15|0.65|0.8|||Fisher Exact|||"null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's"||0.8|0.65|0.05
71919237|NCT03099304|143360389|SUPERIORITY||LSM difference|-29.81|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|95.0|-43.61|-16.0|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-16.00|-43.61|<0.0001
71919238|NCT03099304|143360389|SUPERIORITY||LSM difference|-25.56|STANDARD_ERROR_OF_MEAN|6.75||0.0002|TWO_SIDED|95.0|-38.89|-12.22|||Log Rank|Treatment comparisons were performed using the log-rank test stratified by randomization stratification factor.|LSM difference = treatment minus vehicle|||-12.22|-38.89|0.0002
71919239|NCT03099304|143360401|SUPERIORITY||Odds Ratio (OR)|1.03||||0.4936|TWO_SIDED|95.0|0.05||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.05|0.4936
71919240|NCT03099304|143360401|SUPERIORITY||Odds Ratio (OR)|4.16||||0.114|TWO_SIDED|95.0|0.62||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.62|0.1140
71919241|NCT03099304|143360401|SUPERIORITY||Odds Ratio (OR)|6.1||||0.0501|TWO_SIDED|95.0|1.0||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||1.00|0.0501
71919242|NCT03099304|143360401|SUPERIORITY||Odds Ratio (OR)|3.89||||0.1257|TWO_SIDED|95.0|0.58||The upper limit of the confidence interval was not estimatable because there were too few participants with a response of clear or almost clear.||exact logistic regression|The exact logistic regression model includes treatment and stratification factor (age ≤30 versus \>30).|||||0.58|0.1257
71919243|NCT01401101|143360418|SUPERIORITY_OR_OTHER|||||||0.97|TWO_SIDED|95.0||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); used random effects to account for correlations wi/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.97
71919244|NCT01401101|143360419|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED|95.0|||||Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.54
71919245|NCT01401101|143360420|SUPERIORITY_OR_OTHER|||||||0.33||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); using random effects to control for correlations w/in site \& patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions||||0.33
71919246|NCT02313506|143360433|SUPERIORITY||Mean Difference (Net)|-31.1||||0.02|TWO_SIDED|95.0|-56.6|-5.7||No adjustment was made for multiple comparisons because Type II error is a greater concern than Type I error in feasibility studies.|ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.||-5.7|-56.6|0.02
71919247|NCT02313506|143360433|SUPERIORITY||Mean Difference (Net)|4.6||||0.71|TWO_SIDED|95.0|-19.6|28.9|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.||28.9|-19.6|0.71
71919248|NCT02313506|143360433|SUPERIORITY||Mean Difference (Net)|-11.0||||0.29|TWO_SIDED|95.0|-31.1|9.1|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.||9.1|-31.1|0.29
71919249|NCT03198884|143360487|OTHER|The percent of patients with an RNA \<50 copies/mL at each time point was analyzed using McNemar's test following the guidelines of the Snapshot algorithm. Missing RNA data was considered a treatment failure. Change in mean serum creatinine from baseline was analyzed using Wilcoxon signed rank test.|||||<|0.05|||||||McNemar||||Change in mean CD4+ cell counts from baseline was analyzed using a paired t-test. All analyses used a p-value of less than or equal to 0.05 as significant. Statistical analyses were performed using R software, version 3.4.3.|||<0.05
71919250|NCT03198884|143360488|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71919251|NCT03860181|143360501|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 1's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.896|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 215||||||0.896
71919252|NCT03860181|143360501|EQUIVALENCE|The statistical significance's p-value was set at 0.05. For Surgeon 2's differences, they were calculated as patient POSAS score - surgeon POSAS score, with a negative difference signifying that the patients thought more highly of the scars than the physicians since lower POSAS scores are more favorable.||||||0.612|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney U = 210||||||0.612
71919253|NCT01385098|143360519|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||< 0.001
71919254|NCT01385098|143360520|SUPERIORITY_OR_OTHER|||||||0.013||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.013
71919255|NCT01385098|143360520|SUPERIORITY_OR_OTHER|||||||0.01||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)|||||||0.010
71919256|NCT02253173|143360522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919257|NCT02253173|143360522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919258|NCT02253173|143360522|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71879075|NCT03596866|143278050|SUPERIORITY||Hazard Ratio (HR)|0.968|||=|0.8672|TWO_SIDED|95.0|0.658|1.424||P-value from a 2-sided stratified log-rank test using the stratification factors: presence of intracranial central nervous system (CNS) metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|2-sided Stratified Log-rank Test||The hazard ratio was obtained using the stratified Cox regression model with the same stratification factors.|||1.424|0.658|=0.8672
71879076|NCT03596866|143278051|SUPERIORITY||Hazard Ratio (HR)|1.592|||=|0.0713|TWO_SIDED|95.0|0.956|2.652||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||2.652|0.956|=0.0713
71879077|NCT03596866|143278052|SUPERIORITY||Hazard Ratio (HR)|1.232|||=|0.2501|TWO_SIDED|95.0|0.862|1.761||P-value was based on a 2-sided stratified log-rank test using the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Log Rank||The HR was obtained using the stratified Cox regression model with the same stratification factors.|||1.761|0.862|=0.2501
71879078|NCT03596866|143278053|SUPERIORITY||Odds Ratio (OR)|0.7|||=|0.1555|TWO_SIDED|95.0|0.42|1.15||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|BIRC Assessed||1.15|0.42|=0.1555
71879079|NCT03596866|143278053|SUPERIORITY||Odds Ratio (OR)|0.55|||=|0.0169|TWO_SIDED|95.0|0.33|0.9||P-value was from a Cochran-Mantel-Haenszel test stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Cochran-Mantel-Haenszel||Odds ratio stratified by the stratification factors: presence of intracranial CNS metastases at baseline and best prior response to crizotinib therapy as assessed by the investigator.|Investigator Assessed||0.90|0.33|=0.0169
71879080|NCT03596866|143278056|SUPERIORITY||Odds Ratio (OR)|1.31|||=|0.6246|TWO_SIDED|95.0|0.44|3.84||P-value was from a Cochran-Mantel-Haenszel test stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|Cochran-Mantel-Haenszel||Odds ratio was stratified by best prior response to crizotinib therapy as assessed by the investigator at randomization per IXRS.|||3.84|0.44|=0.6246
71879081|NCT03596866|143278058|SUPERIORITY||||||=|0.0778||||||P-value from a 2-sided stratified Gray's test using the stratification factors (at randomization per IxRS): presence of intracranial CNS metastases at baseline, and best prior response to crizotinib therapy as assessed by the investigator.|Gray's Test|P-value is for the event type: Intracranial Disease Progression without Prior Systemic Progression or Death.||||||=0.0778
71879082|NCT02904915|143278068|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||0.59
71879083|NCT02904915|143278069|SUPERIORITY|||||||0.39|||||||Fisher Exact|||||||0.39
71879084|NCT02904915|143278070|SUPERIORITY|||||||0.23|||||||Fisher Exact|||||||0.23
71879085|NCT03159091|143278071|SUPERIORITY|||||||0.0422|||||||G-test (Chi-square)|||||||0.0422
71879086|NCT03159091|143278072|SUPERIORITY|||||||0.1101|||||||Wilcoxon (Mann-Whitney)|||This analysis applies to ∆ between initial and 4 weeks total scores row.||||0.1101
71879087|NCT03159091|143278073|SUPERIORITY|||||||0.1373|||||||G-test (Chi-square)|||||||0.1373
71879088|NCT03159091|143278074|SUPERIORITY|||||||0.087|||||||Wilcoxon (Mann-Whitney)|||||||0.0870
71879089|NCT03159091|143278075|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71879090|NCT00262522|143278076|SUPERIORITY_OR_OTHER||||||>|0.1||95.0|||||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.||||>0.100
71879091|NCT00262522|143278077|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|1.3||||0.715||95.0|-5.1|7.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||7.8|-5.1|0.715
71882647|NCT02706873|143284650|SUPERIORITY||Response Rate Difference|19.4|||<|0.001|TWO_SIDED|95.0|12.3|26.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||26.5|12.3|<0.001
71882648|NCT02706873|143284651|SUPERIORITY||Response Rate Difference|26.0|||<|0.001|TWO_SIDED|95.0|19.1|33.0||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||33.0|19.1|<0.001
71919259|NCT02253173|143360523|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919260|NCT02253173|143360523|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919261|NCT02253173|143360523|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919262|NCT02253173|143360524|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919263|NCT02253173|143360524|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919264|NCT02253173|143360524|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919265|NCT02253173|143360525|SUPERIORITY_OR_OTHER|||||||0.0149|||||||Mixed Models Analysis|||||||0.0149
71879092|NCT00262522|143278078|NON_INFERIORITY_OR_EQUIVALENCE|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|-4.3||||0.249||95.0|-11.5|2.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.||2.8|-11.5|0.249
71879093|NCT00262522|143278079|SUPERIORITY_OR_OTHER|||||||0.269||95.0|||||ANOVA|||||||0.269
71879094|NCT03740165|143278080|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.0002|TWO_SIDED|95.0|0.53|0.83||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.83|0.53|0.0002
71879095|NCT03740165|143278080|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.3339|TWO_SIDED|95.0|0.77|1.19||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.19|0.77|0.3339
71879096|NCT03740165|143278081|SUPERIORITY||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.61|0.84||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.84|0.61|<0.0001
71879097|NCT03740165|143278081|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5527|TWO_SIDED|95.0|0.87|1.18||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.18|0.87|0.5527
71879098|NCT03740165|143278082|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4314|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4314
71879099|NCT03740165|143278082|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.3107|TWO_SIDED|95.0|0.72|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.72|0.3107
71879100|NCT03740165|143278083|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6716|TWO_SIDED|95.0|0.87|1.25||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.25|0.87|0.6716
71879101|NCT03740165|143278083|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7448|TWO_SIDED|95.0|0.89|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.89|0.7448
71879102|NCT03740165|143278084|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0012|TWO_SIDED|95.0|0.5|0.86||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||0.86|0.50|0.0012
71879103|NCT03740165|143278084|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4366|TWO_SIDED|95.0|0.75|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.27|0.75|0.4366
71879104|NCT03740165|143278085|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0008|TWO_SIDED|95.0|0.61|0.89||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.89|0.61|0.0008
71919266|NCT02253173|143360525|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919267|NCT02253173|143360525|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919268|NCT02253173|143360526|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919269|NCT02253173|143360526|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919270|NCT02253173|143360526|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71686344|NCT01483599|142890254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879105|NCT03740165|143278085|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7174|TWO_SIDED|95.0|0.88|1.27||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.27|0.88|0.7174
71879106|NCT03740165|143278086|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0228|TWO_SIDED|95.0|0.62|1.0||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.00|0.62|0.0228
71879107|NCT03740165|143278086|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.3935|TWO_SIDED|95.0|0.77|1.22||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary) and bevacizumab use (Yes vs No)|||1.22|0.77|0.3935
71879108|NCT03740165|143278087|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0573|TWO_SIDED|95.0|0.74|1.03||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.03|0.74|0.0573
71879109|NCT03740165|143278087|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7234|TWO_SIDED|95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7234
71879110|NCT03740165|143278088|SUPERIORITY||Difference in Least Squares Means (LSM)|0.26||||0.8481|TWO_SIDED|95.0|-2.44|2.97|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.97|-2.44|0.8481
71879111|NCT03740165|143278088|SUPERIORITY||Difference in LS Means|-1.1||||0.4335|TWO_SIDED|95.0|-3.87|1.66|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||1.66|-3.87|0.4335
71879112|NCT03740165|143278089|SUPERIORITY||Difference in Least Squares Means (LSM)|0.14||||0.9024|TWO_SIDED|95.0|-2.15|2.44|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.44|-2.15|0.9024
71879113|NCT03740165|143278089|SUPERIORITY||Difference in Least Squares Means (LSM)|-0.08||||0.9478|TWO_SIDED|95.0|-2.47|2.31|||t-test, 2 sided||Based on cLDA model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery \[planned interval vs R0 following primary vs R1 following primary\], bevacizumab use, and PD-L1 CPS)|||2.31|-2.47|0.9478
71879114|NCT03740165|143278090|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.2644|TWO_SIDED|95.0|0.73|1.17||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.17|0.73|0.2644
71686345|NCT01483599|142890254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879115|NCT03740165|143278090|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.1953|TWO_SIDED|95.0|0.71|1.14||One-sided p-value based on log-rank test stratified by surgery (planned interval debulking versus R0 following primary debulking versus R1 following primary debulking), bevacizumab use (yes versus no), and PD-L1 status (CPS\<10 vs CPS≥10).|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by surgery (planned interval vs R0 following primary vs R1 following primary debulking), bevacizumab use (Yes vs No), PD-L1 status (CPS\<10 vs CPS≥10)|||1.14|0.71|0.1953
71882649|NCT02706873|143284651|SUPERIORITY||Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|24.2|38.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|||38.2|24.2|<0.001
71882650|NCT02706873|143284652|SUPERIORITY|For the Japan sub-study, no multiplicity adjustments were applied and only nominal p-values were provided for all efficacy analyses.|Response Rate Difference|28.3||||0.004|TWO_SIDED|95.0|7.7|48.9|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||48.9|7.7|0.004
71882651|NCT02706873|143284652|SUPERIORITY||Response Rate Difference|28.0||||0.022|TWO_SIDED|95.0|5.3|50.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||50.7|5.3|0.022
71882652|NCT02706873|143284652|SUPERIORITY||Response Rate Difference|21.4||||0.086|TWO_SIDED|95.0|-2.4|45.2|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||45.2|-2.4|0.086
71686346|NCT01483599|142890254|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879116|NCT03740165|143278091|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.5188|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5188
71879117|NCT03740165|143278091|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5091|TWO_SIDED|95.0|0.77|1.3||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.30|0.77|0.5091
71879118|NCT03740165|143278092|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.59|0.8||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||0.80|0.59|<0.0001
71879119|NCT03740165|143278092|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1206|TWO_SIDED|95.0|0.79|1.06||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.06|0.79|0.1206
71879120|NCT03740165|143278093|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0853||95.0|0.76|1.05||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.05|0.76|0.0853
71879121|NCT03740165|143278093|SUPERIORITY||Hazard Ratio (HR)|1.05||||0.7165||95.0|0.89|1.23||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.23|0.89|0.7165
71879122|NCT03740165|143278094|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0442||95.0|0.76|1.02||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.02|0.76|0.0442
71879123|NCT03740165|143278094|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.9565||95.0|0.98|1.31||One-sided p-value based on log-rank test stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|Log Rank||Based on Cox regression model with Efron's method of tie handling; treatment as covariate stratified by debulking surgery (planned interval vs R0 following primary vs R1 following primary), bevacizumab use (Yes vs No), and PD-L1 CPS (\<10 vs ≥10)|||1.31|0.98|0.9565
71879124|NCT03740165|143278095|SUPERIORITY||Difference in Percentage|3.7||||0.0318|TWO_SIDED|95.0|-0.3|7.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.|t-test, 1 sided||Based on Miettinen \& Nurminen method stratified by bevacizumab use (Yes vs No) and PD-L1 CPS (\<10 vs ≥10)|||7.3|-0.3|0.0318
71879125|NCT02044133|143278098|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71879126|NCT05318937|143278099|SUPERIORITY||Difference in LS Means|0.0|STANDARD_ERROR_OF_MEAN|2.07||0.9934|TWO_SIDED|95.0|-4.13|4.09||The p-value was obtained using a MMRM model which included treatment, visit, treatment-by-visit interaction as categorical covariates, and WAIS-IV at baseline as continuous covariates.|MMRM||Difference was calculated as SAGE-718 - placebo.|||4.09|-4.13|0.9934
71879127|NCT05314517|143278107|OTHER||Stratified Common Risk Difference|14.1||||0.1244|TWO_SIDED|90.0|-1.0|29.2|||Cochran-Mantel-Haenszel|||||29.2|-1.0|0.1244
71879128|NCT04490018|143278137|NON_INFERIORITY|The two-sided 95 percent (%) confidence interval (CI) was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater than (\>) -10%.|Difference in Percentage|4.98|||||TWO_SIDED|95.0|0.06|10.36||||||Serogroup A||10.36|0.06|
71879129|NCT04490018|143278137|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|4.97|||||TWO_SIDED|95.0|1.58|9.5||||||Serogroup C||9.50|1.58|
71879130|NCT04490018|143278137|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.28|4.42||||||Serogroup W||4.42|-1.28|
71879131|NCT04490018|143278137|NON_INFERIORITY|The two-sided 95% CI was calculated based on the Wilson score method without continuity correction. The non-inferiority was demonstrated if the lower limit of the 95% CI of the percentage difference between compared groups was greater \> -10%.|Difference in Percentage|1.24|||||TWO_SIDED|95.0|-1.88|4.77||||||Serogroup Y||4.77|-1.88|
71882653|NCT02706873|143284653|SUPERIORITY||Response Rate Difference|38.6|||<|0.001|TWO_SIDED|95.0|18.6|58.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.5|18.6|<0.001
71882654|NCT02706873|143284653|SUPERIORITY||Response Rate Difference|45.2|||<|0.001|TWO_SIDED|95.0|21.8|68.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.6|21.8|<0.001
71879132|NCT04714073|143278165|OTHER||Ratio of geometric means (%)|218.81|||||TWO_SIDED|90.0|194.06|246.72|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 18.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||246.72|194.06|
71879133|NCT04714073|143278166|OTHER||Ratio of geometric means (%)|156.29|||||TWO_SIDED|90.0|135.04|180.89|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 22.1."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||180.89|135.04|
71879134|NCT04714073|143278167|OTHER||Ratio of geometric means (%)|223.12|||||TWO_SIDED|90.0|198.61|250.66|||||"The estimated parameter was the adjusted geometric mean ratio (%): BI 706321 + Itraconazole (Test Treatment(T))/BI 706321 alone (Reference Treatment (R)).~Intra-individual geometric coefficient of variation (gCV) \[%\] = 17.5."|The statistical model used for the analysis of the primary PK endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subject' was considered as random, whereas 'treatment' was considered as fixed.||250.66|198.61|
71879135|NCT00282295|143278168|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|2.18|||||TWO_SIDED|95.0|0.79|4.17||||||The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||4.17|0.79|
71879136|NCT00282295|143278168|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of -10%.|Difference|0.02|||||TWO_SIDED|95.0|-1.4|1.48||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.||1.48|-1.4|
71879137|NCT00282295|143278169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than (\>) the pre-defined limit of 0.67|Adjusted GMC ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.||1.03|0.84|
71879138|NCT00282295|143278169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.76|||||TWO_SIDED|95.0|0.69|0.84||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.||0.84|0.69|
71879139|NCT00282295|143278169|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of 0.67|Adjusted GMC ratio|0.63|||||TWO_SIDED|95.0|0.54|0.72||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.||0.72|0.54|
71879140|NCT00282295|143278170|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-4.38|||||TWO_SIDED|95.0|-9.91|1.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.||1.15|-9.91|
71879141|NCT00282295|143278170|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-3.39|||||TWO_SIDED|95.0|-7.03|0.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.||0.15|-7.03|
71879142|NCT00282295|143278170|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was \> the pre-defined limit of -10%.|Difference in booster response rate|-1.96|||||TWO_SIDED|95.0|-5.25|-1.25||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.||-1.25|-5.25|
71882655|NCT02706873|143284653|SUPERIORITY||Response Rate Difference|50.0|||<|0.001|TWO_SIDED|95.0|27.4|72.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||72.6|27.4|<0.001
71919271|NCT02253173|143360527|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919272|NCT02253173|143360527|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919273|NCT02253173|143360527|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919274|NCT02253173|143360528|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919275|NCT02253173|143360528|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919276|NCT02253173|143360528|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919277|NCT02253173|143360529|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919278|NCT02253173|143360529|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919279|NCT02253173|143360529|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919280|NCT02253173|143360530|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71882656|NCT02706873|143284654|SUPERIORITY||Response Rate Difference|34.5|||<|0.001|TWO_SIDED|95.0|22.0|47.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||47.1|22.0|<0.001
71686347|NCT01483599|142890255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71919281|NCT02253173|143360530|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919282|NCT02253173|143360530|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919283|NCT02253173|143360531|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919284|NCT02253173|143360531|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919285|NCT02253173|143360531|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919286|NCT02253173|143360532|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919287|NCT02253173|143360532|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919288|NCT02253173|143360532|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919289|NCT02253173|143360533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919290|NCT02253173|143360533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919291|NCT02253173|143360533|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71879143|NCT00282295|143278171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|-0.21|||||TWO_SIDED|95.0|-4.85|4.43||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.||4.43|-4.85|
71879144|NCT00282295|143278171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.69|||||TWO_SIDED|95.0|-1.69|5.16||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.||5.16|-1.69|
71882657|NCT02706873|143284654|SUPERIORITY||Response Rate Difference|51.9|||<|0.001|TWO_SIDED|95.0|33.0|70.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.7|33.0|<0.001
71882658|NCT02706873|143284654|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|46.5|82.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||82.0|46.5|<0.001
71882659|NCT02706873|143284655|SUPERIORITY||LS Mean Difference|-1.43|||<|0.001|TWO_SIDED|95.0|-1.92|-0.95|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.95|-1.92|<0.001
71882660|NCT02706873|143284655|SUPERIORITY||LS Mean Difference|-1.86|||<|0.001|TWO_SIDED|95.0|-2.42|-1.3|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.30|-2.42|<0.001
71882661|NCT02706873|143284655|SUPERIORITY||LS Mean Difference|-1.92|||<|0.001|TWO_SIDED|95.0|-2.48|-1.36|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-1.36|-2.48|<0.001
71882662|NCT02706873|143284656|SUPERIORITY||LS Mean Difference|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.34|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.34|-0.75|<0.001
71882663|NCT02706873|143284656|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
71882664|NCT02706873|143284656|SUPERIORITY||LS Mean Difference|-0.75|||<|0.001|TWO_SIDED|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.51|-0.99|<0.001
71882665|NCT02706873|143284657|SUPERIORITY||LS Mean Difference|5.97|||<|0.001|TWO_SIDED|95.0|3.15|8.8|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||8.80|3.15|<0.001
71882666|NCT02706873|143284657|SUPERIORITY||LS Mean Difference|7.92|||<|0.001|TWO_SIDED|95.0|4.66|11.19|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||11.19|4.66|<0.001
71882667|NCT02706873|143284657|SUPERIORITY||LS Mean Difference|6.76|||<|0.001|TWO_SIDED|95.0|3.33|10.2|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||10.20|3.33|<0.001
71882668|NCT02706873|143284658|SUPERIORITY||Response Rate Difference|51.2|||<|0.001|TWO_SIDED|95.0|32.5|70.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||70.0|32.5|<0.001
71882669|NCT02706873|143284658|SUPERIORITY||Response Rate Difference|59.9|||<|0.001|TWO_SIDED|95.0|38.8|81.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.1|38.8|<0.001
71882670|NCT02706873|143284658|SUPERIORITY||Response Rate Difference|60.7|||<|0.001|TWO_SIDED|95.0|39.9|81.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||81.5|39.9|<0.001
71882671|NCT02706873|143284659|SUPERIORITY||Response Rate Difference|49.4|||<|0.001|TWO_SIDED|95.0|30.6|68.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||68.3|30.6|<0.001
71882672|NCT02706873|143284659|SUPERIORITY||Response Rate Difference|52.5|||<|0.001|TWO_SIDED|95.0|30.2|74.8|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||74.8|30.2|<0.001
71879145|NCT00282295|143278171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.82||||||95.0|-2.58|6.25||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.||6.25|-2.58|
71879146|NCT00282295|143278171|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|3.56|||||TWO_SIDED|95.0|0.96|6.45||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination||6.45|0.96|
71879147|NCT01401842|143278198|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on lumbar extension muscular strength (Nm) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.001
71879148|NCT01401842|143278199|SUPERIORITY_OR_OTHER|||||||0.871|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.871
71879149|NCT01401842|143278200|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.||||0.021
71879150|NCT00121108|143278209|SUPERIORITY||Relative risk|0.13|||<|0.001|TWO_SIDED|95.0|0.08|0.21|||Fisher Exact|||||0.21|0.08|<0.001
71879151|NCT01380379|143278220|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|Single group comparison pre-post change score, compared to a value of 0 (no change)||||||<.01
71879152|NCT01380379|143278221|SUPERIORITY_OR_OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<.04
71879153|NCT02971631|143278222|SUPERIORITY|||||||0.008|||||||t-test, 2 sided|Paired analysis||||||0.008
71919292|NCT02253173|143360534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919293|NCT02253173|143360534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919294|NCT02253173|143360534|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919295|NCT02253173|143360535|SUPERIORITY_OR_OTHER|||||||0.026|||||||Mixed Models Analysis|||||||0.0260
71879154|NCT02971631|143278223|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|Paired analysis||||||0.03
71879155|NCT02971631|143278224|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|Paired analysis||For meal consumption rate||||0.79
71879156|NCT02971631|143278226|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Baseline||||0.20
71879157|NCT02971631|143278226|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Paired analysis||Post-OGTT||||0.58
71879158|NCT02971631|143278226|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.39
71879159|NCT02971631|143278226|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.20
71879160|NCT02971631|143278227|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|Paired analysis||Baseline||||0.26
71879161|NCT02971631|143278227|SUPERIORITY|||||||0.06||||||Paired analysis|t-test, 2 sided|||Post-OGTT||||0.06
71879162|NCT02971631|143278227|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|Paired analysis||Pre-meal||||0.95
71879163|NCT02971631|143278227|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|Paired analysis||Post-meal||||0.88
71879164|NCT02971631|143278228|SUPERIORITY|||||||1|||||||Other|0 events over whole study, no statistical test appropriate||||||1
71879165|NCT02971631|143278229|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.84
71879166|NCT00449670|143278249|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.81||||||95.0|0.66|1.01|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 2).||1.01|0.66|
71879167|NCT00449670|143278249|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.69|1.06|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 3).||1.06|0.69|
71879168|NCT00449670|143278249|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.85|||||TWO_SIDED|95.0|0.68|1.05|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 4).||1.05|0.68|
71879169|NCT00449670|143278249|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.05|||||TWO_SIDED|95.0|0.85|1.3|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 3).||1.3|0.85|
71879170|NCT00449670|143278249|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 4).||1.29|0.84|
71879171|NCT00449670|143278249|EQUIVALENCE|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the \[0.5 ; 2\] clinical limit interval.|Adjusted GMT ratio|0.99|||||TWO_SIDED|95.0|0.8|1.23|||ANCOVA|||Demonstration of the consistency of the immune response (in terms of geometric mean titer \[GMT\] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 3 and Lot 4).||1.23|0.8|
71879172|NCT00847145|143278295|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-5.0|2.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.||2|-5|
71882673|NCT02706873|143284659|SUPERIORITY||Response Rate Difference|64.3|||<|0.001|TWO_SIDED|95.0|44.2|84.3|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||84.3|44.2|<0.001
71686348|NCT01483599|142890255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71919296|NCT02253173|143360535|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
71919297|NCT02253173|143360535|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
71919298|NCT02253173|143360536|SUPERIORITY_OR_OTHER|||||||0.0069|||||||Mixed Models Analysis|||||||0.0069
71919299|NCT02253173|143360536|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Mixed Models Analysis|||||||0.0009
71919300|NCT02253173|143360536|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919301|NCT02253173|143360537|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71919302|NCT02253173|143360537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919303|NCT02253173|143360537|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919304|NCT02253173|143360538|SUPERIORITY_OR_OTHER|||||||0.1269|||||||Mixed Models Analysis|||||||0.1269
71919305|NCT02253173|143360538|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Mixed Models Analysis|||||||0.0019
71919306|NCT02253173|143360538|SUPERIORITY_OR_OTHER|||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
71919307|NCT02253173|143360539|SUPERIORITY_OR_OTHER|||||||0.0094|||||||Mixed Models Analysis|||||||0.0094
71919308|NCT02253173|143360539|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71919309|NCT02253173|143360539|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71919310|NCT02253173|143360540|SUPERIORITY_OR_OTHER|||||||0.0128|||||||Mixed Models Analysis|||||||0.0128
71919311|NCT02253173|143360540|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919312|NCT02253173|143360540|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Mixed Models Analysis|||||||0.0008
71919313|NCT02253173|143360541|SUPERIORITY_OR_OTHER|||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
71919314|NCT02253173|143360541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919315|NCT02253173|143360541|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919316|NCT02253173|143360542|SUPERIORITY_OR_OTHER|||||||0.9616|||||||Mixed Models Analysis|||||||0.9616
71919317|NCT02253173|143360542|SUPERIORITY_OR_OTHER|||||||0.2439|||||||Mixed Models Analysis|||||||0.2439
71919318|NCT02253173|143360542|SUPERIORITY_OR_OTHER|||||||0.6518|||||||Mixed Models Analysis|||||||0.6518
71919319|NCT02253173|143360543|SUPERIORITY_OR_OTHER|||||||0.7829|||||||Mixed Models Analysis|||||||0.7829
71919320|NCT02253173|143360543|SUPERIORITY_OR_OTHER|||||||0.2328|||||||Mixed Models Analysis|||||||0.2328
71919321|NCT02253173|143360543|SUPERIORITY_OR_OTHER|||||||0.4118|||||||Mixed Models Analysis|||||||0.4118
71919322|NCT02253173|143360544|SUPERIORITY_OR_OTHER|||||||0.0639|||||||Mixed Models Analysis|||||||0.0639
71919323|NCT02253173|143360544|SUPERIORITY_OR_OTHER|||||||0.0356|||||||Mixed Models Analysis|||||||0.0356
71919324|NCT02253173|143360544|SUPERIORITY_OR_OTHER|||||||0.0914|||||||Mixed Models Analysis|||||||0.0914
71919325|NCT02253173|143360545|SUPERIORITY_OR_OTHER|||||||0.0503|||||||Mixed Models Analysis|||||||0.0503
71919326|NCT02253173|143360545|SUPERIORITY_OR_OTHER|||||||0.0055|||||||Mixed Models Analysis|||||||0.0055
71919327|NCT02253173|143360545|SUPERIORITY_OR_OTHER|||||||0.0263|||||||Mixed Models Analysis|||||||0.0263
71919328|NCT02253173|143360546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919329|NCT02253173|143360546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919330|NCT02253173|143360546|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919331|NCT02253173|143360547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919332|NCT02253173|143360547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919333|NCT02253173|143360547|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919334|NCT02253173|143360548|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919335|NCT02253173|143360548|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919336|NCT02253173|143360548|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919337|NCT02253173|143360549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919338|NCT02253173|143360549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919339|NCT02253173|143360549|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919340|NCT02253173|143360550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919341|NCT02253173|143360550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919342|NCT02253173|143360550|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919343|NCT02253173|143360551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919344|NCT02253173|143360551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919345|NCT02253173|143360551|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919346|NCT02253173|143360552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919347|NCT02253173|143360552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919348|NCT02253173|143360552|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919349|NCT02253173|143360553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919350|NCT02253173|143360553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919351|NCT02253173|143360553|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919352|NCT02253173|143360554|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919353|NCT02253173|143360554|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919354|NCT02253173|143360554|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919355|NCT02253173|143360555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919356|NCT02253173|143360555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919357|NCT02253173|143360555|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919358|NCT02253173|143360556|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919359|NCT02253173|143360556|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919360|NCT02253173|143360556|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919361|NCT02253173|143360557|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919362|NCT02253173|143360557|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919363|NCT02253173|143360557|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919364|NCT02253173|143360558|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
71919365|NCT02253173|143360558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919366|NCT02253173|143360558|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919367|NCT02253173|143360559|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71919368|NCT02253173|143360559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919369|NCT02253173|143360559|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919370|NCT02253173|143360560|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919371|NCT02253173|143360560|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919372|NCT02253173|143360560|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919373|NCT02253173|143360561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919374|NCT02253173|143360561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919375|NCT02253173|143360561|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||||||< 0.0001
71919376|NCT02253173|143360562|SUPERIORITY_OR_OTHER|||||||0.9075|||||||ANCOVA|||||||0.9075
71919377|NCT02253173|143360562|SUPERIORITY_OR_OTHER|||||||0.0492|||||||ANCOVA|||||||0.0492
71919378|NCT02253173|143360562|SUPERIORITY_OR_OTHER|||||||0.0019|||||||ANCOVA|||||||0.0019
71919379|NCT02253173|143360563|SUPERIORITY_OR_OTHER|||||||0.9719|||||||ANCOVA|||||||0.9719
71919380|NCT02253173|143360563|SUPERIORITY_OR_OTHER|||||||0.0614|||||||ANCOVA|||||||0.0614
71919381|NCT02253173|143360563|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|||||||0.0085
71919382|NCT02253173|143360564|SUPERIORITY_OR_OTHER|||||||0.9999|||||||ANCOVA|||||||0.9999
71919383|NCT02253173|143360564|SUPERIORITY_OR_OTHER|||||||0.2855|||||||ANCOVA|||||||0.2855
71919384|NCT02253173|143360564|SUPERIORITY_OR_OTHER|||||||0.1189|||||||ANCOVA|||||||0.1189
71919385|NCT02253173|143360565|SUPERIORITY_OR_OTHER|||||||0.4162|||||||ANCOVA|||||||0.4162
71919386|NCT02253173|143360565|SUPERIORITY_OR_OTHER|||||||0.0013|||||||ANCOVA|||||||0.0013
71919387|NCT02253173|143360565|SUPERIORITY_OR_OTHER|||||||0.0003|||||||ANCOVA|||||||0.0003
71919388|NCT02253173|143360566|SUPERIORITY_OR_OTHER|||||||0.9929|||||||ANCOVA|||||||0.9929
71919389|NCT02253173|143360566|SUPERIORITY_OR_OTHER|||||||0.9634|||||||ANCOVA|||||||0.9634
71919390|NCT02253173|143360566|SUPERIORITY_OR_OTHER|||||||0.0898|||||||ANCOVA|||||||0.0898
71919391|NCT02253173|143360567|SUPERIORITY_OR_OTHER|||||||0.5146|||||||ANCOVA|||||||0.5146
71919392|NCT02253173|143360567|SUPERIORITY_OR_OTHER|||||||0.0099|||||||ANCOVA|||||||0.0099
71919393|NCT02253173|143360567|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.0150
71919394|NCT02253173|143360568|SUPERIORITY_OR_OTHER|||||||0.9039|||||||ANCOVA|||||||0.9039
71919395|NCT02253173|143360568|SUPERIORITY_OR_OTHER|||||||0.3751|||||||ANCOVA|||||||0.3751
71919396|NCT02253173|143360568|SUPERIORITY_OR_OTHER|||||||0.0073|||||||ANCOVA|||||||0.0073
71879173|NCT00847145|143278295|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.|Percentage group difference|0.0|||||TWO_SIDED|95.0|-5.0|5.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.||5|-5|
71882674|NCT02706873|143284660|SUPERIORITY||LS Mean Difference|-1.69||||0.063|TWO_SIDED|95.0|-3.47|0.09|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||0.09|-3.47|0.063
71882675|NCT02706873|143284660|SUPERIORITY||LS Mean Difference|-2.4||||0.022|TWO_SIDED|95.0|-4.45|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.45|0.022
71882676|NCT02706873|143284660|SUPERIORITY||LS Mean Difference|-2.45||||0.022|TWO_SIDED|95.0|-4.54|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate|||-0.35|-4.54|0.022
71882677|NCT02706873|143284661|SUPERIORITY||Response Rate Difference|36.2||||0.001|TWO_SIDED|95.0|14.4|58.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.0|14.4|0.001
71882678|NCT02706873|143284661|SUPERIORITY||Response Rate Difference|34.6||||0.01|TWO_SIDED|95.0|10.2|59.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||59.0|10.2|0.010
71882679|NCT02706873|143284661|SUPERIORITY||Response Rate Difference|33.0||||0.016|TWO_SIDED|95.0|7.9|58.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate|||58.1|7.9|0.016
71882680|NCT02595723|143284669|OTHER|||||||0.003||||||Overall group difference adjusted for prior group, time, and baseline values.|Mixed Models Analysis|Model includes prior group, time, and baseline values to control for possible effects.||||||0.003
71882681|NCT00004259|143284670|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.36|TWO_SIDED|95.0|0.67|1.32|||Log Rank|||The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.||1.32|0.67|0.36
71882682|NCT00004259|143284672|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.46|TWO_SIDED|95.0|0.55|1.16||2-sided|Gray's test||Reference level = RT + BCNU/CCNU|||1.16|0.55|0.46
71882683|NCT00004259|143284673|SUPERIORITY||||||<|0.001||||||2-sided|Chi-squared|||Overall toxicity||||<0.001
71882684|NCT00004259|143284673|SUPERIORITY|||||||0.76||||||2-sided|Chi-squared|||Non-hematologic toxicity||||0.76
71882685|NCT00004259|143284674|SUPERIORITY||Hazard Ratio (HR)|1.78||||0.08|TWO_SIDED|95.0|0.93|3.4|||Log Rank|Two-side significance level = 0.05|Reference level = Methylated MGMT|||3.40|0.93|0.08
71882686|NCT00004259|143284675|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.41|TWO_SIDED|95.0|0.7|2.35|||Log Rank|Two-sided confidence interval = 0.5|Reference level = Methylated|||2.35|0.70|0.41
71882687|NCT00531752|143284697|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.7947|STANDARD_ERROR_OF_MEAN|1.8848||0.6749|TWO_SIDED|80.0|-1.649|3.2383||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2383|-1.649|0.6749
71882688|NCT00531752|143284697|SUPERIORITY_OR_OTHER||LS Mean Difference|1.4176|STANDARD_ERROR_OF_MEAN|2.0343||0.4886|TWO_SIDED|80.0|-1.218|4.0533||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0533|-1.218|0.4886
71882689|NCT00531752|143284698|SUPERIORITY_OR_OTHER||LS Mean Difference|1.025|STANDARD_ERROR_OF_MEAN|1.7713||0.5643|TWO_SIDED|80.0|-1.262|3.3121|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3121|-1.262|0.5643
71882690|NCT00531752|143284698|SUPERIORITY_OR_OTHER||LS Mean Difference|1.9146|STANDARD_ERROR_OF_MEAN|1.8777||0.3107|TWO_SIDED|80.0|-0.51|4.3392|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.3392|-0.5100|0.3107
71879174|NCT00847145|143278295|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-4.0|1.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.||1|-4|
71686349|NCT01483599|142890255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879175|NCT00847145|143278295|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.|Percentage group difference|-1.0|||||TWO_SIDED|95.0|-6.0|3.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.||3|-6|
71879176|NCT00847145|143278295|NON_INFERIORITY_OR_EQUIVALENCE|The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.|Percentage group difference|-2.0|||||TWO_SIDED|95.0|-11.0|7.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.||7|-11|
71879177|NCT01798589|143278309|OTHER|Bioequivalence is assessed based on concordance between the 2 allergen using Kappa statistic|Concordance|66.7|||||TWO_SIDED|95.0|41.6|90.2||||||||90.2|41.6|
71879178|NCT02232802|143278342|EQUIVALENCE|Following logarithmic transformation, Cmax values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|99.42|||||TWO_SIDED|95.0|96.28|102.65|||||Geometric least square means are being compared.|Statistical comparison for Anti-FXa||102.65|96.28|
71879179|NCT02232802|143278342|EQUIVALENCE|Following logarithmic transformation, Cmax was subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|91.55|||||TWO_SIDED|95.0|86.65|96.73|||||Geometric least square means are being compared.|Statistical comparison on Anti-FIIa||96.73|86.65|
71879180|NCT02232802|143278343|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean difference ratio|102.89|||||TWO_SIDED|95.0|100.67|105.15|||||Geometric least square means are being compared.|Anti-FXa statistical comparison||105.15|100.67|
71879181|NCT02232802|143278343|EQUIVALENCE|Following logarithmic transformation, AUC0-t values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence.|least square mean difference ratio|92.37|||||TWO_SIDED|95.0|87.72|97.25|||||Geometric least square means are being compared.|Anti-FIIa comparison||97.25|87.72|
71879182|NCT02232802|143278344|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|104.26|||||TWO_SIDED|95.0|101.68|106.9|||||Geometric least square means are being compared.|Anti-FXA comparison||106.9|101.68|
71879183|NCT02232802|143278344|EQUIVALENCE|Following logarithmic transformation, AUC0-inf values were subjected to an analysis of variance (ANOVA), including fixed effects for sequence, period, treatment and subject nested within sequence|least square mean ratio|90.44|||||TWO_SIDED|95.0|85.38|95.8|||||Geometric least square means are being compared.|Anti-FIIa comparison||95.8|85.38|
71879184|NCT02232802|143278345|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.7642|TWO_SIDED|95.0|-0.5|0.5||An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FXa comparison||0.5|-0.5|0.7642
71879185|NCT02232802|143278345|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % non-parametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|least square mean ratio|0.0||||0.9464|TWO_SIDED|95.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||Geometric least square means are being compared.|Anti-FIIa comparison||0.5|-0.5|0.9464
71879186|NCT02232802|143278351|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|103.94|||||TWO_SIDED|95.0|101.22|106.73||||||||106.73|101.22|
71879187|NCT02232802|143278352|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|108.59|||||TWO_SIDED|95.0|103.93|113.46||||||||113.46|103.93|
71879188|NCT02232802|143278353|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|Geometric least square mean ratio|102.76|||||TWO_SIDED|95.0|97.51|108.28||||||||108.28|97.51|
71879189|NCT02232802|143278354|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|114.91|||||TWO_SIDED|95.0|102.29|129.08||||||||129.08|102.29|
71919397|NCT00410514|143360570|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.4|||||TWO_SIDED|95.0|-0.63|1.42|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.42|-0.63|
71919398|NCT00410514|143360570|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.62|||||TWO_SIDED|95.0|-0.43|1.68|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||1.68|-0.43|
71919399|NCT00410514|143360572|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-5.94|||||TWO_SIDED|95.0|-13.98|2.09|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||2.09|-13.98|
71919400|NCT00410514|143360572|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-1.39|||||TWO_SIDED|95.0|-9.73|6.96|||ANCOVA||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.||6.96|-9.73|
71919401|NCT00631969|143360640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.109|||<|0.0001||95.0|-8.562|-5.6561|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.||-5.6561|-8.562|< 0.0001
71919402|NCT00631969|143360641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.027|||<|0.0001||95.0|-35.519|-22.534|||ANCOVA|||Statistical analysis applies to the total population.||-22.534|-35.519|< 0.0001
71919403|NCT00631969|143360642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.193|||<|0.0001||95.0|-45.021|-31.366|||ANCOVA|||Statistical analysis applies to the total population.||-31.366|-45.021|< 0.0001
71919404|NCT00631969|143360643|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|34.778|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.||Statistical analysis applies to the total population.||||<0.0001
71919405|NCT00631969|143360644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.503|||<|0.0001||95.0|-22.424|-10.764|||ANCOVA|||Statistical analysis applies to the total population.||-10.764|-22.424|< 0.0001
71919406|NCT00631969|143360645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.167|||<|0.0001||95.0|-45.261|-31.073|||ANCOVA|||Statistical analysis applies to the total population.||-31.073|-45.261|< 0.0001
71919407|NCT00631969|143360646|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.555|||<|0.0001||95.0|-43.645|-29.465|||ANCOVA|||Statistical analysis applies to the total population.||-29.465|-43.645|< 0.0001
71919408|NCT00631969|143360647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.193|||<|0.0001||95.0|-31.562|-18.824|||ANCOVA|||Statistical analysis applies to the total population.||-18.824|-31.562|< 0.0001
71919409|NCT00631969|143360649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.703|||<|0.0001||95.0|-30.067|-19.34|||ANCOVA|||Statistical analysis applies to the total population.||-19.340|-30.067|< 0.0001
71686350|NCT01483599|142890255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71919410|NCT00631969|143360650|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.496|||<|0.0001||95.0|-34.865|-24.128|||ANCOVA|||Statistical analysis applies to the total population.||-24.128|-34.865|< 0.0001
71919411|NCT00631969|143360651|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.775|||<|0.0001||95.0|-33.155|-22.394|||ANCOVA|||Statistical analysis applies to the total population.||-22.394|-33.155|< 0.0001
71919412|NCT00631969|143360652|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.326|||<|0.0001||95.0|-29.062|-17.598|||ANCOVA|||Statistical analysis applies to the total population.||-17.598|-29.062|< 0.0001
71919413|NCT00631969|143360653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.384|||<|0.0001||95.0|-28.594|-18.175|||ANCOVA|||Statistical analysis applies to the total population.||-18.175|-28.594|< 0.0001
71919414|NCT00631969|143360654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.076|||<|0.0001||95.0|-38.745|-27.407|||ANCOVA|||Statistical analysis applies to the total population.||-27.407|-38.745|< 0.0001
71919415|NCT00631969|143360655|SUPERIORITY_OR_OTHER||Cochran-Mantel-Haenszel|74.449|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.||Statistical analysis applies to the total population.||||<0.0001
71919416|NCT00631969|143360656|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|117.42||||||90.0|79.59|173.23||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||173.23|79.59|
71919417|NCT00631969|143360656|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7064||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.7064
71919418|NCT00631969|143360657|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|133.07||||||90.0|87.46|202.46||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||202.46|87.46|
71919419|NCT00631969|143360657|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.8749||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.8749
71919420|NCT00631969|143360658|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|125.28||||||90.0|73.65|213.11||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \< 65 years) were calculated.||213.11|73.65|
71919421|NCT00631969|143360658|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7375||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.||||0.7375
71919422|NCT00631969|143360659|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|123.84||||||90.0|80.12|191.42||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.||191.42|80.12|
71919423|NCT00631969|143360659|NON_INFERIORITY_OR_EQUIVALENCE|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.394||95.0|||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.||||0.3940
71919424|NCT02043704|143360706|EQUIVALENCE|The null hypothesis is that there is no difference in the pain scores between the groups.||||||0.328||||||The p-value was not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|There were no adjustments.||The comparison was analyzed using the Mann-Whitney U test.||||0.328
71919425|NCT01432236|143360751|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.61||||0.0001|TWO_SIDED|95.0|-0.91|-0.31||Primary analysis was two-sided and performed at the 0.05 significance level.|Mixed Models Analysis|Satterthwaite's approximation was used to estimate denominator degrees of freedom.||Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-0.91|0.0001
71919426|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|||<|0.0001|TWO_SIDED|95.0|-9.33|-3.87||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-3.87|-9.33|<0.0001
71919427|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.42||||0.0078|TWO_SIDED|95.0|-0.74|-0.11||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.11|-0.74|0.0078
71919428|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.85||||0.0014|TWO_SIDED|95.0|-1.36|-0.33||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.33|-1.36|0.0014
71686351|NCT01483599|142890255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879190|NCT02232802|143278355|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Median Difference (Final Values)|0.0|||=|0.8554|TWO_SIDED|95.0|-0.5|0.5|||ANOVA|||||0.5|-0.5|= 0.8554
71879191|NCT02232802|143278356|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|geometric least square mean ratio|100.86|||||TWO_SIDED|95.0|99.27|102.47||||||||102.47|99.27|
71879192|NCT02232802|143278357|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence.|geometric least square mean ratio|95.13|||||TWO_SIDED|95.0|85.7|105.6||||||||105.6|85.7|
71879193|NCT02232802|143278358|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.6857|TWO_SIDED|95.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.5|-0.25|= 0.6857
71879194|NCT02232802|143278364|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|111.39|||||TWO_SIDED|95.0|105.89|117.17||||||||117.17|105.89|
71879195|NCT02232802|143278365|EQUIVALENCE|Results obtained using a fixed effects ANOVA with fixed effects for sequence, period, treatment and subject nested within sequence|Geometric least square mean ratio|113.82|||||TWO_SIDED|95.0|107.47|120.53||||||||120.53|107.47|
71879196|NCT02232802|143278370|EQUIVALENCE|An assessment of tmax was performed using the Wilcoxon matched pairs test. In addition, a 95 % nonparametric CI was constructed for the median difference in tmax based on the method of Campbell and Gardner.|Median Difference (Final Values)|0.0|||=|0.9217|TWO_SIDED|95.0|-0.13|0.13|||Wilcoxon (Mann-Whitney)||Median difference is the difference between median tmax in Test IMP versus Reference IMP arms.|||0.13|-0.13|= 0.9217
71879197|NCT01180478|143278392|SUPERIORITY_OR_OTHER|||||||0.585|||||||Log Rank|||The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).||||0.585
71879198|NCT01180478|143278393|SUPERIORITY_OR_OTHER|||||||0.742|||||||Chi-squared|||||||0.742
71879199|NCT01180478|143278394|SUPERIORITY_OR_OTHER|||||||0.17|||||||Fisher Exact|The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.||The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.||||0.170
71879200|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.311|||||||Chi-squared|||Comparison of the numbers in 'Bleeding' between NBI and WL||||0.311
71879201|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.666|||||||Chi-squared|||Comparison of the numbers in 'Fever' between NBI and WL||||0.666
71879202|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.569|||||||Chi-squared|||Comparison in the number of 'UTI' between NBI and WL||||0.569
71879203|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.111|||||||Chi-squared|||Comparison in the number of 'Bladder cramps' between NBI and WL||||0.111
71879204|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'DVT' between NBI and WL|Non of the participants/patients had DVT. Therefore, the p-value is not available|||
71879205|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'CVA/TIA' between NBI and WL||||0.500
71879206|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||||||||||||Comparison in the number of 'Lung embolism' between NBI and WL|Non of the participants/patients had a lung embolism. Therefore, no p-value was available|||
71879207|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'Sepsis' between NBI and WL||||0.500
71879208|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Comparison in the number of 'Acute Abdomen' between NBI and WL||||1.000
71879209|NCT01180478|143278395|SUPERIORITY_OR_OTHER|||||||0.17|||||||Chi-squared|||Comparison in the number of 'Other perioperative complication' between NBI and WL||||0.170
71879210|NCT01180478|143278396|SUPERIORITY_OR_OTHER|||||||0.553|TWO_SIDED||||||Chi-squared|||||||0.553
71919429|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.005|TWO_SIDED|95.0|-1.01|-0.18||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.18|-1.01|0.0050
71879211|NCT00054704|143278397|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.828|STANDARD_ERROR_OF_MEAN|3.182||0.086|TWO_SIDED|95.0|-12.59|0.934||A linear mixed model included drug, visit and their interaction as fixed factors. Subject was a random factor. The test here is for the main effect of drug.|Mixed Models Analysis|Baseline score was a covariate. Restricted maximum likelihood estimates were used with a compound symmetry covariance structure.||The primary intent of this study was to compare the efficacy of riluzole to placebo in the treatment of overall depressive symptomatology of bipolar disorder subjects who were acutely depressed. Data from 8 riluzole and 11 placebo participants were analyzed due to missing data for one riluzole patient.||0.934|-12.590|.086
71879212|NCT02187471|143278443|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.191||0.4601|TWO_SIDED|95.0|-0.52|0.23|||Difference of means|||||0.23|-0.52|0.4601
71879213|NCT02187471|143278443|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.035|TWO_SIDED|95.0|-0.77|-0.03|||Difference of means|||||-0.03|-0.77|0.0350
71879214|NCT02187471|143278443|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.191||0.0001|TWO_SIDED|95.0|-1.12|-0.37|||Difference of means|||||-0.37|-1.12|0.0001
71879215|NCT02187471|143278443|SUPERIORITY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.193||0.0019|TWO_SIDED|95.0|0.22|0.98|||Difference of means|||||0.98|0.22|0.0019
71879216|NCT02187471|143278443|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.192||0.0761|TWO_SIDED|95.0|-0.04|0.72|||Difference of means|||||0.72|-0.04|0.0761
71879217|NCT02187471|143278445|SUPERIORITY||Mean Difference (Final Values)|-1.59|STANDARD_ERROR_OF_MEAN|1.67||0.3407|TWO_SIDED|95.0|-4.86|1.68|||Difference of means|||||1.68|-4.86|0.3407
71879218|NCT02187471|143278445|SUPERIORITY||Mean Difference (Final Values)|-5.42|STANDARD_ERROR_OF_MEAN|1.669||0.0012|TWO_SIDED|95.0|-8.69|-2.15|||Difference of means|||||-2.15|-8.69|0.0012
71879219|NCT02187471|143278445|SUPERIORITY||Mean Difference (Final Values)|-4.39|STANDARD_ERROR_OF_MEAN|1.665||0.0083|TWO_SIDED|95.0|-7.66|-1.13|||Difference of means|||||-1.13|-7.66|0.0083
71879220|NCT02187471|143278445|SUPERIORITY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|1.677||0.0946|TWO_SIDED|95.0|-0.48|6.09|||Difference of means|||||6.09|-0.48|0.0946
71879221|NCT02187471|143278445|SUPERIORITY||Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|1.669||0.5384|TWO_SIDED|95.0|-4.3|2.24|||Difference of means|||||2.24|-4.30|0.5384
71879222|NCT02187471|143278447|SUPERIORITY||Difference in least squares means|-0.9|STANDARD_ERROR_OF_MEAN|0.3||0.003|TWO_SIDED|95.0|-1.5|-0.3|||ANCOVA|||||-0.3|-1.5|0.0030
71879223|NCT02187471|143278447|SUPERIORITY||Difference in least squares means|-1.7|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.3|-1.1|||ANCOVA|||||-1.1|-2.3|<0.0001
71879224|NCT02187471|143278447|SUPERIORITY||Difference in least squares means|-1.2|STANDARD_ERROR_OF_MEAN|0.3||0.0001|TWO_SIDED|95.0|-1.7|-0.6|||ANCOVA|||||-0.6|-1.7|0.0001
71879225|NCT02187471|143278447|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3562|TWO_SIDED|95.0|-0.3|0.9|||ANCOVA|||||0.9|-0.3|0.3562
71879226|NCT02187471|143278447|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0862|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA|||||0.1|-1.1|0.0862
71879227|NCT02187471|143278448|SUPERIORITY||Difference in least square means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.5183|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.7|0.5183
71879228|NCT02187471|143278448|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2669|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.2|-0.9|0.2669
71879229|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.463|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.4630
71879230|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.28||0.928|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.5|0.9280
71879231|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.28||0.7089|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.7|0.7089
71879232|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0669|TWO_SIDED|95.0|-1.1|0.0|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0|-1.1|0.0669
71879233|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.28||0.0081|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||-0.2|-1.3|0.0081
71879234|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.28||0.0867|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.1|-1.0|0.0867
71879235|NCT02187471|143278448|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.9066|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.6|0.9066
71879236|NCT02187471|143278448|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.29||0.3509|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.3|-0.8|0.3509
71879237|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|2.187|STANDARD_ERROR_OF_MEAN|0.6203||0.0004|TWO_SIDED|95.0|0.97|3.404|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.404|0.970|0.0004
71879238|NCT02187471|143278449|SUPERIORITY||Difference of least squares means|2.483|STANDARD_ERROR_OF_MEAN|0.6209|<|0.0001|TWO_SIDED|95.0|1.265|3.701|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||3.701|1.265|<0.0001
71879239|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|2.621|STANDARD_ERROR_OF_MEAN|0.6215|<|0.0001|TWO_SIDED|95.0|1.401|3.84|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||3.840|1.401|<0.0001
71879240|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|-0.434|STANDARD_ERROR_OF_MEAN|0.6245||0.4877|TWO_SIDED|95.0|-1.659|0.792|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.792|-1.659|0.4877
71879241|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|-0.137|STANDARD_ERROR_OF_MEAN|0.6252||0.8263|TWO_SIDED|95.0|-1.364|1.089|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.089|-1.364|0.8263
71879242|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|0.228|STANDARD_ERROR_OF_MEAN|0.7345||0.7567|TWO_SIDED|95.0|-1.213|1.669|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.669|-1.213|0.7567
71879243|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|0.7349|STANDARD_ERROR_OF_MEAN|0.7349||0.0787|TWO_SIDED|95.0|-0.149|2.735|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||2.735|-0.149|0.0787
71879244|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|0.7358|STANDARD_ERROR_OF_MEAN|0.7358||0.3516|TWO_SIDED|95.0|-0.758|2.129|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.129|-0.758|0.3516
71879245|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|-0.458|STANDARD_ERROR_OF_MEAN|0.7372||0.5344|TWO_SIDED|95.0|-1.905|0.988|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.988|-1.905|0.5344
71879246|NCT02187471|143278449|SUPERIORITY||Difference in least squares means|0.607|STANDARD_ERROR_OF_MEAN|0.7379||0.4107|TWO_SIDED|95.0|-0.84|2.055|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||2.055|-0.840|0.4107
71879247|NCT02187471|143278450|SUPERIORITY||Difference in least squares means|0.0203|STANDARD_ERROR_OF_MEAN|0.01369||0.1394|TWO_SIDED|95.0|-0.0066|0.0471|||ANCOVA|||||0.0471|-0.0066|0.1394
71879248|NCT02187471|143278450|SUPERIORITY||Difference in least squares means|0.0211|STANDARD_ERROR_OF_MEAN|0.01369||0.1237|TWO_SIDED|95.0|-0.0058|0.048|||ANCOVA|||||0.0480|-0.0058|0.1237
71879249|NCT02187471|143278450|SUPERIORITY||Difference in least squares means|0.0386|STANDARD_ERROR_OF_MEAN|0.01371||0.0049|TWO_SIDED|95.0|0.0117|0.0655|||ANCOVA|||||0.0655|0.0117|0.0049
71879250|NCT02187471|143278450|SUPERIORITY||Difference in least squares means|-0.0184|STANDARD_ERROR_OF_MEAN|0.01378||0.1824|TWO_SIDED|95.0|-0.0454|0.0086|||ANCOVA|||||0.0086|-0.0454|0.1824
71879251|NCT02187471|143278450|SUPERIORITY||Difference in least squares means|-0.0175|STANDARD_ERROR_OF_MEAN|0.01378||0.2036|TWO_SIDED|95.0|-0.0446|0.0095|||ANCOVA|||||0.0095|-0.0446|0.2036
71879252|NCT02187471|143278451|SUPERIORITY||Difference in least squares means|-0.56|STANDARD_ERROR_OF_MEAN|0.162||0.0006|TWO_SIDED|95.0|-0.87|-0.24|||Mixed Models Analysis|||||-0.24|-0.87|0.0006
71879253|NCT02187471|143278451|SUPERIORITY||Difference in least squares means|-0.88|STANDARD_ERROR_OF_MEAN|0.16|<|0.0001|TWO_SIDED|95.0|-1.2|-0.57|||Mixed Models Analysis|||||-0.57|-1.20|<0.0001
71879254|NCT02187471|143278451|SUPERIORITY||Difference in least squares means|-0.95|STANDARD_ERROR_OF_MEAN|0.161|<|0.0001|TWO_SIDED|95.0|-1.27|-0.63|||Mixed Models Analysis|||||-0.63|-1.27|<0.0001
71879255|NCT02187471|143278451|SUPERIORITY||Difference in least squares means|0.39|STANDARD_ERROR_OF_MEAN|0.162||0.0158|TWO_SIDED|95.0|0.07|0.71|||Mixed Models Analysis|||||0.71|0.07|0.0158
71879256|NCT02187471|143278451|SUPERIORITY||Difference in least squares means|0.07|STANDARD_ERROR_OF_MEAN|0.161||0.6819|TWO_SIDED|95.0|-0.25|0.38|||Mixed Models Analysis|||||0.38|-0.25|0.6819
71879257|NCT02187471|143278453|SUPERIORITY||Difference of least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
71879258|NCT02187471|143278453|SUPERIORITY||Difference of least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2005|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.1|-0.6|0.2005
71879259|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||-0.3|-1.0|0.0010
71879260|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|0.2|1.0|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||1.0|0.2|0.0030
71879261|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3351|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3351
71879262|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.18|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
71879263|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.0782|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0782
71879264|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0068|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||-0.1|-0.9|0.0068
71879265|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0169|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0169
71879266|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.1481|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1481
71879267|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||-0.4|-1.1|<0.0001
71879268|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0088|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||-0.1|-0.8|0.0088
71879269|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.17||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||-0.3|-0.9|0.0005
71879270|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0627|TWO_SIDED|95.0|0.0|0.7|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.0|0.0627
71879271|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.3064|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3064
71879272|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||-0.4|-1.2|<0.0001
71879273|NCT02187471|143278453|SUPERIORITY||Difference in least squares mean|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.0868|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.0|-0.7|0.0868
71879274|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.7|STANDARD_ERROR_OF_MEAN|0.2||0.0004|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||-0.3|-1.1|0.0004
71879275|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0271|TWO_SIDED|95.0|0.1|0.8|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|0.1|0.0271
71879276|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.6838|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.3|0.6838
71879277|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.791|STANDARD_ERROR_OF_MEAN|0.172|<|0.0001|TWO_SIDED|95.0|-1.129|-0.454|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||-0.454|-1.129|<0.0001
71879278|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.33|STANDARD_ERROR_OF_MEAN|0.1718||0.0552|TWO_SIDED|95.0|-0.667|0.007|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.007|-0.667|0.0552
71879279|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-0.612|STANDARD_ERROR_OF_MEAN|0.1718||0.0004|TWO_SIDED|95.0|-0.95|-0.275|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||-0.275|-0.950|0.0004
71879280|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.462|STANDARD_ERROR_OF_MEAN|0.1729||0.0077|TWO_SIDED|95.0|0.122|0.801|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.801|0.122|0.0077
71879281|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|0.179|STANDARD_ERROR_OF_MEAN|0.173||0.3014|TWO_SIDED|95.0|-0.161|0.518|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.518|-0.161|0.3014
71879282|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|9.6|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001|TWO_SIDED|95.0|4.9|14.3|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||14.3|4.9|<0.0001
71879283|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|8.5|STANDARD_ERROR_OF_MEAN|2.39||0.0004|TWO_SIDED|95.0|3.8|13.2|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||13.2|3.8|0.0004
71879284|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|10.4|STANDARD_ERROR_OF_MEAN|2.39|<|0.0001|TWO_SIDED|95.0|5.7|15.1|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg BID||15.1|5.7|<0.0001
71879285|NCT02187471|143278453|SUPERIORITY||Difference in least squares means|-1.1|STANDARD_ERROR_OF_MEAN|2.41||0.6449|TWO_SIDED|95.0|-5.8|3.6|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.6|-5.8|0.6449
71879286|NCT02187471|143278453|SUPERIORITY||Difference in least square means|0.8|STANDARD_ERROR_OF_MEAN|2.41||0.734|TWO_SIDED|95.0|-3.9|5.5|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.5|-3.9|0.7340
71879287|NCT02187471|143278454|SUPERIORITY||Difference in least squares means|-0.016|STANDARD_ERROR_OF_MEAN|0.0225||0.4816|TWO_SIDED|95.0|-0.06|0.028|||ANCOVA|||||0.028|-0.060|0.4816
71879288|NCT02187471|143278454|SUPERIORITY||Difference in least square means|-0.064|STANDARD_ERROR_OF_MEAN|0.0225||0.0044|TWO_SIDED|95.0|-0.109|-0.02|||ANCOVA|||||-0.020|-.109|0.0044
71879289|NCT02187471|143278454|SUPERIORITY||Difference in least squares means|-0.074|STANDARD_ERROR_OF_MEAN|0.0226||0.001|TWO_SIDED|95.0|-0.119|-0.03|||ANCOVA|||||-0.030|-0.119|0.0010
71879290|NCT02187471|143278454|SUPERIORITY||Difference in least squares means|0.059|STANDARD_ERROR_OF_MEAN|0.0226||0.0094|TWO_SIDED|95.0|0.014|0.103|||ANCOVA|||||0.103|0.014|0.0094
71879291|NCT02187471|143278454|SUPERIORITY||Difference in least squares means|0.01|STANDARD_ERROR_OF_MEAN|0.0226||0.6527|TWO_SIDED|95.0|-0.034|0.055|||ANCOVA|||||0.055|-0.034|0.6527
71879292|NCT01785160|143278456|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability (No formal testing was performed)|Adjusted Geometric Mean ratio|272.06|STANDARD_DEVIATION|67.9||0.9999||95.0|199.69|370.66||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||370.66|199.69|0.9999
71919430|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.75||||0.0002|TWO_SIDED|95.0|-1.14|-0.36||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.36|-1.14|0.0002
71919431|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.64||||0.0006|TWO_SIDED|95.0|-1.0|-0.28||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.28|-1.00|0.0006
71919432|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.0315|TWO_SIDED|95.0|-0.85|-0.04||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.04|-0.85|0.0315
71919433|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.76||||0.0003|TWO_SIDED|95.0|-1.17|-0.35||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.35|-1.17|0.0003
71919434|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0007|TWO_SIDED|95.0|-1.11|-0.31||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.31|-1.11|0.0007
71919435|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55||||0.0048|TWO_SIDED|95.0|-0.93|-0.17||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.17|-0.93|0.0048
71919436|NCT01432236|143360753|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.32|-0.53||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.53|-1.32|<0.0001
71879293|NCT01785160|143278457|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability(No formal testing was performed)|Adjusted Geometric Mean ratio|245.72|STANDARD_DEVIATION|87.1||0.9973||95.0|168.46|358.404||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir||358.404|168.460|0.9973
71879294|NCT02318667|143278469|OTHER|||||||0.0074|||||||t-test, 2 sided|||||||0.0074
71879295|NCT02318667|143278470|OTHER|||||||0.1506|||||||t-test, 2 sided|||||||0.1506
71879296|NCT04223843|143278483|OTHER||Difference of adjusted means|0.336|STANDARD_ERROR_OF_MEAN|0.045|<|0.0001|TWO_SIDED|95.0|0.246|0.425|||ANCOVA|Model included fixed categorical effects of treatment and the fixed continous effect of baseline FEV1 AUC0-3.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3 change from baseline between Tio+Olo and matching placebo.||0.425|0.246|<0.0001
71879297|NCT04223843|143278483|OTHER||Difference of adjusted means|0.321|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.233|0.409|||ANCOVA|Model included the fixed categorical effect of treatment and the fixed continuous effect of baseline FEV1 AUC0-3h.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean FEV1 AUC0-3h change from baseline between Tio+Olo and matching placebo.||0.409|0.233|<0.0001
71879298|NCT04223843|143278484|OTHER||Difference of adjusted means|0.201|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.117|0.286|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.286|0.117|<0.0001
71879299|NCT04223843|143278484|OTHER||Difference of adjusted means|0.217|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.135|0.299|||Mixed Models Analysis|Mixed model with repeated measures including fixed categorial effect of treatment at each visit and fixed continuous effect of baseline at each visit.|Difference = (Tio+Olo) - (Placebo)|H0: There is no difference in the mean trough FEV1 change from baseline between Tio+Olo and matching placebo.||0.299|0.135|<0.0001
71879300|NCT00253643|143278485|SUPERIORITY_OR_OTHER|||||||0.1521|TWO_SIDED|||||Utilized a priori threshold for statistical significance of 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores||||0.1521
71879301|NCT00253643|143278486|SUPERIORITY_OR_OTHER|||||||0.1573|TWO_SIDED|||||A priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67||||0.1573
71879302|NCT02636582|143278491|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||||||0.71
71879303|NCT02636582|143278492|SUPERIORITY|||||||0.964|||||||Wilcoxon (Mann-Whitney)|||||||0.964
71879304|NCT02636582|143278493|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1
71879305|NCT02636582|143278494|OTHER|||||||0.172||||||HER2 expression - biopsy|Fisher Exact|||||||0.172
71879306|NCT02636582|143278494|OTHER|||||||0.38||||||HER2 expression - resection|Fisher Exact|||||||0.38
71879307|NCT01263483|143278501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.002|||||TWO_SIDED|95.0|-1.166|-0.838||||||||-0.838|-1.166|
71879308|NCT01263483|143278501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.947|||||TWO_SIDED|95.0|-1.097|-0.796||||||||-0.796|-1.097|
71879309|NCT01263483|143278502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176|||||TWO_SIDED|95.0|-0.229|-0.123||||||||-0.123|-0.229|
71879310|NCT01263483|143278502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19|||||TWO_SIDED|95.0|-0.247|-0.133||||||||-0.133|-0.247|
71879311|NCT01263483|143278503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.421|||||TWO_SIDED|95.0|-0.507|-0.334||||||||-0.334|-0.507|
71879312|NCT01263483|143278503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.414|||||TWO_SIDED|95.0|-0.504|-0.324||||||||-0.324|-0.504|
71879313|NCT01263483|143278504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.738|||||TWO_SIDED|95.0|-0.871|-0.605||||||||-0.605|-0.871|
71879314|NCT01263483|143278504|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.749|||||TWO_SIDED|95.0|-0.875|-0.623||||||||-0.623|-0.875|
71879315|NCT01263483|143278505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.01|||||TWO_SIDED|95.0|-18.5|-5.52||||||||-5.52|-18.50|
71879316|NCT01263483|143278505|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.33|||||TWO_SIDED|95.0|-21.93|-8.73||||||||-8.73|-21.93|
71879317|NCT01263483|143278506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.65|||||TWO_SIDED|95.0|-23.02|-8.27||||||||-8.27|-23.02|
71879318|NCT01263483|143278506|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.03|||||TWO_SIDED|95.0|-29.68|-14.38||||||||-14.38|-29.68|
71879319|NCT01263483|143278507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3|||||TWO_SIDED|95.0|-26.09|-10.5||||||||-10.50|-26.09|
71879320|NCT01263483|143278507|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.34|||||TWO_SIDED|95.0|-27.34|-11.34||||||||-11.34|-27.34|
71879321|NCT01263483|143278508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.53|||||TWO_SIDED|95.0|-21.46|-5.6||||||||-5.60|-21.46|
71879322|NCT01263483|143278508|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.97|||||TWO_SIDED|95.0|-21.53|-4.41||||||||-4.41|-21.53|
71879323|NCT01263483|143278509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-0.304|0.104||||||||0.104|-0.304|
71879324|NCT01263483|143278509|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.036|||||TWO_SIDED|95.0|-0.239|0.167||||||||0.167|-0.239|
71879325|NCT01263483|143278510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.013|||||TWO_SIDED|95.0|-0.267|0.292||||||||0.292|-0.267|
71879326|NCT01263483|143278510|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.034|||||TWO_SIDED|95.0|-0.264|0.196||||||||0.196|-0.264|
71879327|NCT01263483|143278511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.038|||||TWO_SIDED|95.0|-0.268|0.191||||||||0.191|-0.268|
71879328|NCT01263483|143278511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.073|||||TWO_SIDED|95.0|-0.261|0.115||||||||0.115|-0.261|
71879329|NCT01263483|143278512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|||||TWO_SIDED|95.0|-0.183|0.252||||||||0.252|-0.183|
71879330|NCT01263483|143278512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|||||TWO_SIDED|95.0|-0.124|0.288||||||||0.288|-0.124|
71879331|NCT01263483|143278513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-31.54|||||TWO_SIDED|95.0|-41.28|-21.8||||||||-21.80|-41.28|
71879332|NCT01263483|143278513|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.73|||||TWO_SIDED|95.0|-44.88|-22.57||||||||-22.57|-44.88|
71879333|NCT01263483|143278514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.38|||||TWO_SIDED|95.0|-90.67|-50.09||||||||-50.09|-90.67|
71879334|NCT01263483|143278514|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.49|||||TWO_SIDED|95.0|-93.1|-51.88||||||||-51.88|-93.10|
71879335|NCT01263483|143278515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.093|||||TWO_SIDED|95.0|2.229|11.958||||||||11.958|2.229|
71879336|NCT01263483|143278515|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.967|||||TWO_SIDED|95.0|-0.521|8.455||||||||8.455|-0.521|
71879337|NCT01263483|143278516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55|||||TWO_SIDED|95.0|-0.045|1.144||||||||1.144|-0.045|
71879338|NCT01263483|143278516|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.428|||||TWO_SIDED|95.0|-0.233|1.09||||||||1.090|-0.233|
71879339|NCT01263483|143278517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.77|||||TWO_SIDED|95.0|-36.65|-0.9||||||||-0.90|-36.65|
71879340|NCT01263483|143278517|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.04|||||TWO_SIDED|95.0|-37.82|-2.27||||||||-2.27|-37.82|
71879341|NCT01372384|143278534|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 4 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed.||||0.045
71879342|NCT01372384|143278534|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Partial Response at Visit 6 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed||||1.000
71879343|NCT01372384|143278534|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 6 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||1.000
71879344|NCT01372384|143278534|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Stable Disease Vs Progression of disease at Visit 6 (Two proportions for of Stable Disease Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Stable Disease Vs Progression of disease was analyzed||||1.000
71879345|NCT01372384|143278534|SUPERIORITY_OR_OTHER|||||||0.274|TWO_SIDED||||||"Clopper-Pearson exact method"|||Response assessment of Partial Response Vs Progression of disease at Visit 10 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed||||0.274
71879346|NCT01131676|143278541|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.86|||<|0.0001|TWO_SIDED|95.02|0.74|0.99||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||0.99|0.74|<0.0001
71879347|NCT01131676|143278541|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0382|TWO_SIDED|95.02|0.74|0.99||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.99|0.74|0.0382
71879348|NCT01131676|143278542|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.02|0.78|1.01||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|<0.0001
71882691|NCT00531752|143284698|SUPERIORITY_OR_OTHER||LS Mean Difference|2.3154|STANDARD_ERROR_OF_MEAN|1.4638||0.1196|TWO_SIDED|80.0|0.41601|4.2148|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2148|0.41601|0.1196
71882692|NCT00531752|143284698|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3288|STANDARD_ERROR_OF_MEAN|1.524||0.3872|TWO_SIDED|80.0|-0.649|3.3065|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3065|-0.6490|0.3872
71882693|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1677|STANDARD_ERROR_OF_MEAN|1.0269||0.8708|TWO_SIDED|80.0|-1.162|1.4971|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4971|-1.162|0.8708
71919437|NCT01432236|143360754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0637|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.||||0.0637
71919438|NCT01432236|143360755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.116|TWO_SIDED|||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using CMH test with modified ridit transformation.||||0.1160
71919439|NCT01432236|143360756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0007
71919440|NCT01432236|143360756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0205|TWO_SIDED|||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.||||0.0205
71919441|NCT01432236|143360757|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.0001|TWO_SIDED|95.0|0.31|0.84||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.||0.84|0.31|<0.0001
71919442|NCT01432236|143360758|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.81||||0.0018|TWO_SIDED|95.0|-12.66|-2.96||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-2.96|-12.66|0.0018
71919443|NCT01432236|143360759|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8||||0.0117|TWO_SIDED|95.0|-10.29|-1.31||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors||-1.31|-10.29|0.0117
71879349|NCT01131676|143278542|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0795|TWO_SIDED|95.02|0.78|1.01||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.||1.01|0.78|0.0795
71879350|NCT01131676|143278543|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.28||||0.4172|TWO_SIDED|95.0|0.7|2.33||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||2.33|0.70|0.4172
71879351|NCT01131676|143278544|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.5|0.85||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.85|0.50|0.0017
71879352|NCT01131676|143278545|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.2547|TWO_SIDED|95.0|0.87|1.04||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||1.04|0.87|0.2547
71919444|NCT01432236|143360760|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.35||||0.0511|TWO_SIDED|95.0|-0.04|16.74||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||16.74|-0.04|0.0511
71919445|NCT01432236|143360761|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13||||0.1139|TWO_SIDED|95.0|-0.29|0.03||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.||0.03|-0.29|0.1139
71879353|NCT01131676|143278546|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.72||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.72|0.54|<0.0001
71879354|NCT01131676|143278547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.54|0.7||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|||0.70|0.54|<0.0001
71879355|NCT00896779|143278548|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71879356|NCT00896779|143278548|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||t-test, 2 sided|||||||0.06
71879357|NCT00829179|143278549|SUPERIORITY_OR_OTHER||Difference in Mean|11.0|STANDARD_DEVIATION|13.3||0.005||95.0|||||Sign test|||||||0.005
71879358|NCT00941668|143278574|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71879359|NCT00941668|143278575|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71879360|NCT00916149|143278589|OTHER||||||>|0.05||||||For each group (levetiracetam and no treatment), the change in IEDs/hour from pre to post-intervention: p \>0.05. The a priori threshold for statistical significance was p=0.05.|Wilcoxon Signed Ranks Test|||Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)||||>0.05
71686352|NCT01483599|142890255|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (\<=90 kg, \>90 kg).||||< 0.001
71879361|NCT00916149|143278590|OTHER|||||||0.005|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.||||0.005
71919446|NCT01432236|143360763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.95|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.5||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||-0.50|-1.40|<0.0001
71879362|NCT00916149|143278590|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.||||>0.05
71879363|NCT00916149|143278591|OTHER|||||||0.016|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.||||0.016
71879364|NCT00916149|143278591|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.||||>0.05
71879365|NCT00916149|143278592|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.||||>0.05
71879366|NCT00916149|143278592|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.||||>0.05
71879367|NCT00916149|143278593|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.||||>0.05
71879368|NCT00916149|143278593|OTHER|||||||0.045|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.||||0.045
71879369|NCT00916149|143278594|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.||||>0.05
71879370|NCT00916149|143278594|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.||||>0.05
71879371|NCT00916149|143278595|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment group||||>0.05
71919447|NCT01432236|143360763|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.88||||0.0005|TWO_SIDED|95.0|-1.37|-0.39||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.||-0.39|-1.37|0.0005
71879372|NCT00916149|143278595|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment group||||>0.05
71879373|NCT00916149|143278596|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment group||||>0.05
71879374|NCT00916149|143278596|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment group||||>0.05
71879375|NCT00916149|143278597|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment group||||>0.05
71879376|NCT00916149|143278598|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment group||||>0.05
71879377|NCT00916149|143278598|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment group||||>0.05
71879378|NCT00916149|143278599|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment group||||>0.05
71879379|NCT00916149|143278599|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment group||||>0.05
71879380|NCT00916149|143278600|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment group||||>0.05
71879381|NCT00916149|143278600|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment group||||>0.05
71879382|NCT00916149|143278601|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment group||||>0.05
71879383|NCT00916149|143278601|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
71879384|NCT00916149|143278602|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the no treatment group||||>0.05
71879385|NCT00916149|143278602|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment group||||>0.05
71879386|NCT00916149|143278603|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment group||||>0.05
71686353|NCT01483599|142890256|SUPERIORITY_OR_OTHER||Difference in Percentage|-24.0|||||TWO_SIDED|95.0|-44.0|-4.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||-4.0|-44.0|
71879387|NCT00916149|143278603|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment group||||>0.05
71879388|NCT00916149|143278604|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment group||||>0.05
71879389|NCT00916149|143278604|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment group||||>0.05
71879390|NCT00916149|143278605|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment group||||>0.05
71879391|NCT00916149|143278605|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment group||||>0.05
71879392|NCT00916149|143278606|OTHER|||||||0.014|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment group||||0.014
71879393|NCT00916149|143278606|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment group||||>0.05
71879394|NCT00916149|143278607|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment group||||>0.05
71879395|NCT00916149|143278607|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
71879396|NCT00916149|143278608|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment group||||>0.05
71879397|NCT00916149|143278608|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment group||||>0.05
71879398|NCT00916149|143278609|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment group||||>0.05
71879399|NCT00916149|143278610|OTHER|||||||0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment group||||0.05
71879400|NCT00916149|143278611|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
71879401|NCT00916149|143278611|OTHER|||||||0.039|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||0.039
71879402|NCT00916149|143278612|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
71879403|NCT00916149|143278612|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
71686354|NCT01483599|142890256|SUPERIORITY_OR_OTHER||Difference in Percentage|2.8|||||TWO_SIDED|95.0|-17.9|23.5||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||23.5|-17.9|
71879404|NCT00916149|143278613|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment group||||>0.05
71879405|NCT00916149|143278613|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
71879406|NCT00916149|143278614|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment group||||>0.05
71879407|NCT00916149|143278614|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
71879408|NCT00916149|143278615|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
71879409|NCT00916149|143278615|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
71879410|NCT00916149|143278616|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
71879411|NCT00916149|143278616|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
71879412|NCT00916149|143278617|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment group||||>0.05
71919448|NCT01432236|143360765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.3854|TWO_SIDED|95.0|-0.02|0.06||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.06|-0.02|0.3854
71879413|NCT00916149|143278617|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment group||||>0.05
71879414|NCT00916149|143278618|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment group||||>0.05
71879415|NCT00916149|143278618|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment group||||>0.05
71879416|NCT00916149|143278619|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment group||||>0.05
71879417|NCT00916149|143278619|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment group||||>0.05
71919449|NCT01432236|143360767|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.55||||0.0085|TWO_SIDED|95.0|0.14|0.97||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.||0.97|0.14|0.0085
71919450|NCT04607291|143360795|OTHER|A logistic regression model was used to identify factors associated with screening.|||||||||||||||||"A logistic regression model was used to identify factors associated with screening. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, stool test recommended by physician, know where to get stool test, fear of colonoscopy index score, ABR - afraid score, and knowledge that colonoscopy can reduce worry.~AUC: 0.71"|||
71919451|NCT04607291|143360796|OTHER|A logistic regression model was used to identify characteristics associated with high intent of getting a Fit test.||||||||||||||||Evaluating factors associated with high intent of getting a Fit test.|"A logistic regression model was used to identify factors associated with high intent of getting a fit test. A stepwise selection procedure (alpha entry and alpha exit = 0.15) was used to determine what factors were included in the model. Overall performance is assessed using the AUC.~Factors included in the model: sex, race, stool test or colonoscopy recommended by physician, know where to get stool test, CBPR score, and barriers to screening score.~AUC: 0.80"|||
71919452|NCT05466240|143360804|EQUIVALENCE|For each post-baseline collection time point, treatment difference and p-value comparing the mean change in viral load from baseline between treatment arms from an analysis of covariance model with covariate baseline viral load.|||||<|0.95|||||||ANCOVA|||||||<0.95
71919453|NCT01749930|143360822|NON_INFERIORITY|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs \<1.5 mmHg at all time points of each visit and \<1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI\<0 mmHg at all time points of each visit.||||||0.216||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol. Superiority of BOL-303259-X to timolol was demonstrated at 8 of 9 time points (exception at 8 am Week 2).|ANCOVA|||||||0.216
71919454|NCT01749930|143360823|OTHER|||||||0.084|||||||Chi-squared|||||||0.084
71879418|NCT00916149|143278620|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the no treatment group||||>0.05
71879419|NCT00916149|143278620|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment group||||>0.05
71919455|NCT01749930|143360824|OTHER|||||||0.007|||||||Chi-squared|||||||0.007
71919456|NCT01749930|143360825|OTHER||||||||||||||||||No statistical analysis was performed on these proportions|||
71919457|NCT04735432|143360831|NON_INFERIORITY|This was a phase 3, multicenter, randomized, open-label, parallel-group, 12-week study to evaluate the noninferiority of the pharmacodynamic effect of efgartigimod PH20 SC 1000 mg compared with efgartigimod IV 10 mg/kg in patients with generalized myasthenia gravis.|LS mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.782|<|0.0001|TWO_SIDED|95.0|-7.73|-0.66|||ANCOVA|||The primary endpoint was analyzed using an ANCOVA model with treatment as a factor and total IgG levels at baseline as a covariate. The NI evaluation was based on a percent reduction from baseline in total IgG levels at day 29 (week 4) using an NI margin of 10%. Only the results for mITT analysis set are entered.||-0.66|-7.73|< 0.0001
71922335|NCT01682876|143365198|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY|Vaccines Group Differences at Day 86|29.0|||||TWO_SIDED|97.5|18.4|40.0|||MN method|||Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY||40|18.4|
71922336|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|18.0|||||TWO_SIDED|98.75|9.1|28.0|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||28|9.1|
71922337|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|28.0||||||98.75|17.1|38.7|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||38.7|17.1|
71922338|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|14.0|||||TWO_SIDED|98.75|1.0|27.1|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||27.1|1|
71882694|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8607|STANDARD_ERROR_OF_MEAN|1.0912||0.0927|TWO_SIDED|80.0|0.44874|3.2726|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.2726|0.44874|0.0927
71919458|NCT03474380|143360898|SUPERIORITY|A generalized linear mixed model (GLMM) with a negative binomial distribution and a log link was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods) and site. The final model was adjusted for Veteran characteristics, including age, gender, race, marital status, service connection, rural status, and chronic disease burden concurrence score (Nosos).|rate ratio (RR)|0.58||||0.091|TWO_SIDED|95.0|0.31|1.09|||generalized linear mixed model (GLMM)||Rate ratio, rate of days not in the community in 6 month intervals in intervention versus usual care.|Days not at home in 6 month intervals.||1.09|0.31|0.091
71882695|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.866|STANDARD_ERROR_OF_MEAN|0.9037||0.3405|TWO_SIDED|80.0|-0.3008|2.0329|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.0329|-0.3008|0.3405
71919459|NCT03474380|143360899|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.0||||0.98|TWO_SIDED|95.0|-0.7|0.8|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.8|-0.7|0.98
71919460|NCT03474380|143360900|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|0.4||||0.167|TWO_SIDED|95.0|-0.2|1.0|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||1.0|-0.2|0.167
71919461|NCT03474380|143360901|SUPERIORITY|A generalized linear mixed model (GLMM) was fit including a time-varying indicator for when iHI-FIVES program launched, fixed effects for time (indicator variables for each of the time periods), site, and indicator for the time point of the survey, and an indicator for the interaction of the time point of the survey with the time-varying indicator for treatment. The final model was adjusted for caregiver characteristics.|Mean Difference (Net)|-0.5||||0.122|TWO_SIDED|95.0|-1.0|0.1|||Mixed Models Analysis||This is the estimated mean difference from baseline to 3 months between usual care and intervention.|||0.1|-1.0|0.122
71919462|NCT00945945|143360902|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.105|TWO_SIDED|95.0|-0.07|0.75||P-value for Change from Baseline to Endpoint (BOCF).|ANCOVA|Main Effect Model: Change = Treatment + Pooled Investigator + Baseline (Type III sums of squares).|Least Squares Mean Difference = DLX30-PLA minus PLA-DLX60.|||0.75|-0.07|0.105
71919463|NCT00626327|143360913|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.4|0.5||||||Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.||0.5|-3.4|
71919464|NCT00626327|143360913|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for mumps was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV - MMRV )|1.0|||||TWO_SIDED|95.0|-1.0|3.7||||||Non-inferiority of immune response to mumps following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||3.7|-1|
71919465|NCT00626327|143360913|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for rubella was greater than -5%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-2.0|||||TWO_SIDED|95.0|-4.5|0.8||||||Non-inferiority of immune response to rubella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||0.8|-4.5|
71922339|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine groups Differences at Day 86|28.0|||||TWO_SIDED|98.75|16.2|39.3|||MN method|||Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.3|16.2|
71922340|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine groups differences at Day 86|11.0|||||TWO_SIDED|98.75|1.0|21.2|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA||21.2|1|
71922341|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine Group differences at Day 86|18.0|||||TWO_SIDED|97.5|9.5|27.1|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC||27.1|9.5|
71922342|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine Group Differences at Day 86|5.0|||||TWO_SIDED|98.75|-8.4|18.8|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW||18.8|-8.4|
71922343|NCT01682876|143365199|SUPERIORITY_OR_OTHER||Vaccine group Differences at Day 86|29.0|||||TWO_SIDED|98.75|17.0|39.6|||MN method|||Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY||39.6|17|
71879420|NCT01940471|143278624|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample sizes of 288 and 576 participants in the TDF and TAF groups, respectively, were planned to give 84% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size based on the assumption that the expected difference (TAF - TDF) in the proportion of participants with HBV DNA \< 29 IU/mL was 0 and the proportion of participants with HBV DNA \< 29 IU/mL in the TDF group was 69%. Missing data were treated as not achieving the primary endpoint.|Difference in proportions|-3.6|||||TWO_SIDED|95.0|-9.8|2.6|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA \< 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.||2.6|-9.8|
71879421|NCT03462719|143278646|SUPERIORITY||Hazard Ratio (HR)|0.216|||<|0.0001|TWO_SIDED|95.0|0.131|0.357|||Log Rank|||||0.357|0.131|<0.0001
71879422|NCT03451851|143278666|SUPERIORITY||Difference in percentage|49.9|||<|0.001|TWO_SIDED|95.0|25.9|69.4|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||69.4|25.9|<0.001
71879423|NCT03451851|143278667|SUPERIORITY||Difference in percentage|55.6|||<|0.001|TWO_SIDED|95.0|32.1|74.0|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||74.0|32.1|<0.001
71879424|NCT03451851|143278668|SUPERIORITY||Difference in percentage|40.1|||=|0.003|TWO_SIDED|95.0|15.6|61.3|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||61.3|15.6|=0.003
71879425|NCT03451851|143278669|SUPERIORITY||Difference in percentage|35.0|||=|0.004|TWO_SIDED|95.0|10.5|56.8|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.8|10.5|=0.004
71879426|NCT03451851|143278670|SUPERIORITY||Difference in percentage|34.1|||=|0.002|TWO_SIDED|25.0|9.7|56.1|||Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||56.1|9.7|=0.002
71879427|NCT03451851|143278671|SUPERIORITY||LS Mean difference|-5.4|||<|0.001|TWO_SIDED|95.0|-7.33|-3.06|||Mixed model repeated measures (MMRM)|||Guselkumab Vs Placebo||-3.06|-7.33|<0.001
71879428|NCT03451851|143278677|SUPERIORITY||Difference in percentage|59.8|||<|0.001|TWO_SIDED|95.0|36.9|77.6||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||77.6|36.9|<0.001
71879429|NCT03451851|143278685|SUPERIORITY||Difference in percentage|46.7|||=|0.002|TWO_SIDED|95.0|21.9|67.3||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||||67.3|21.9|=0.002
71879430|NCT03451851|143278687|SUPERIORITY||Difference in Percentage|23.1|||=|0.139|TWO_SIDED|95.0|-3.4|47.0||p-value is nominal|Fisher Exact|P-values represented the comparisons with placebo and were based on the Fisher's exact test stratified by age group and region (pooled).||Guselkumab Vs Placebo||47.0|-3.4|=0.139
71879431|NCT03451851|143278689|SUPERIORITY||Difference in LS Mean|-5.44|||<|0.001|TWO_SIDED|95.0|-8.0|-2.87||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-2.87|-8.00|<0.001
71879432|NCT03451851|143278691|SUPERIORITY||LS Mean difference|-14.78|||<|0.001|TWO_SIDED|95.0|-20.28|-9.28||p-value is nominal|MMRM model|||Guselkumab Vs Placebo||-9.28|-20.28|<0.001
71686355|NCT01483599|142890256|SUPERIORITY_OR_OTHER||Difference in Percentage|20.4|||||TWO_SIDED|95.0|1.5|39.3||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||39.3|1.5|
71919466|NCT00626327|143360913|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroprotection for varicella was greater than -10%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-1.0|||||TWO_SIDED|95.0|-3.9|1.2||||||Non-inferiority of immune response to varicella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.||1.2|-3.9|
71919467|NCT00626327|143360914|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-4.7|4.5||||||Non-inferiority of immune response of MenACWY-CRM against serogroup A when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||4.5|-4.7|
71919468|NCT00626327|143360914|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||TWO_SIDED|95.0|-1.8|1.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup C when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||1.9|-1.8|
71919469|NCT00626327|143360914|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|1.0|||||TWO_SIDED|95.0|-1.3|3.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup W-135 when concomitantly administered with MMRV vaccine as compared to MenACWY vaccine given alone.||3.9|-1.3|
71919470|NCT00626327|143360914|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|2.0|||||TWO_SIDED|95.0|-1.9|5.3||||||Non-inferiority of immune response of MenACWY-CRM against serogroup Y when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.||5.3|-1.9|
71919471|NCT00626327|143360919|NON_INFERIORITY_OR_EQUIVALENCE|The immune response of MMRV+MenACWY group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentages of subjects with seroconversion for varicella was greater than -10%.|Difference% (MenACWY-CRM+MMRV- MMRV)|-1.0|||||TWO_SIDED|95.0|-2.4|0.8||||||Non-inferiority of anti-varicella response following one dose of MMRV when administered concomitantly with MenACWY vaccine as compared to MMRV administered alone.||0.8|-2.4|
71919472|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.596||||0.0045|TWO_SIDED|95.0|1.704|18.378|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week \[Wk\] 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||18.378|1.704|0.0045
71919473|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.989||||0.9755|TWO_SIDED|95.0|0.497|1.967|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.967|0.497|0.9755
71919474|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.743||||0.4786|TWO_SIDED|95.0|0.327|1.688|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.688|0.327|0.4786
71919475|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38||||0.014|TWO_SIDED|95.0|1.405|20.597|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.597|1.405|0.0140
71686356|NCT01483599|142890256|SUPERIORITY_OR_OTHER||Difference in Percentage|27.7|||||TWO_SIDED|95.0|9.8|45.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||45.6|9.8|
71686357|NCT01483599|142890256|SUPERIORITY_OR_OTHER||Difference in Percentage|25.4|||||TWO_SIDED|95.0|7.2|43.6||||||||43.6|7.2|
71879433|NCT05885737|143278701|EQUIVALENCE|Testing of primary efficacy endpoint was 2-sided and conducted at the 5% significance level. The efficacy of difelikefalin was to be declared for this study if null hypothesis of no treatment difference in the primary efficacy analysis was rejected in favor of the alternative that participants randomized to difelikefalin experience significantly different itching compared to participants randomized to placebo. The null hypothesis was to be rejected if the 2-sided p value was less than (\<) 0.05.|Least square mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.223||0.0003|TWO_SIDED|95.0|-1.25|-0.37|||MMRM|||The null hypothesis in this study was that there was no treatment difference in the primary efficacy analysis of the primary endpoint. The alternative hypothesis was that in participants randomized to difelikefalin there was a significant treatment difference in change in itching compared to participants randomized to placebo. The assessment was based on the mean change from baseline in the weekly mean of the daily 24-hour WI-NRS score at Week 4 of the DB period.||-0.37|-1.25|0.0003
71879434|NCT00307151|143278713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.6||||0.015|TWO_SIDED|95.0|3.7|33.6||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months)and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||33.6|3.7|0.015
71882696|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1623|STANDARD_ERROR_OF_MEAN|0.9622||0.8665|TWO_SIDED|80.0|-1.08|1.4047|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.4047|-1.080|0.8665
71882697|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3886|STANDARD_ERROR_OF_MEAN|0.9694||0.6901|TWO_SIDED|80.0|-0.8694|1.6466|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6466|-0.8694|0.6901
71882698|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|1.3779|STANDARD_ERROR_OF_MEAN|1.0114||0.179|TWO_SIDED|80.0|0.06498|2.6908|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.6908|0.06498|0.1790
71686358|NCT01483599|142890257|SUPERIORITY_OR_OTHER||Difference in Percentage|-15.4|||||TWO_SIDED|95.0|-37.7|6.9||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||6.9|-37.7|
71686359|NCT01483599|142890257|SUPERIORITY_OR_OTHER||Difference in Percentage|10.8|||||TWO_SIDED|95.0|-10.7|32.4||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||32.4|-10.7|
71686360|NCT01483599|142890257|SUPERIORITY_OR_OTHER||Difference in Percentage|22.7|||||TWO_SIDED|95.0|1.8|43.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||43.6|1.8|
71882699|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8759|STANDARD_ERROR_OF_MEAN|0.7508||0.0156|TWO_SIDED|80.0|0.90156|2.8502|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.8502|0.90156|0.0156
71882700|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04217|STANDARD_ERROR_OF_MEAN|0.7842||0.9573|TWO_SIDED|80.0|-1.06|0.97559|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.97559|-1.060|0.9573
71882701|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1602|STANDARD_ERROR_OF_MEAN|1.2517||0.8986|TWO_SIDED|80.0|-1.462|1.782|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.7820|-1.462|0.8986
71882702|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6688|STANDARD_ERROR_OF_MEAN|1.3437||0.6204|TWO_SIDED|80.0|-1.071|2.4086|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4086|-1.071|0.6204
71882703|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.492|STANDARD_ERROR_OF_MEAN|0.8742||0.5759|TWO_SIDED|80.0|-0.6421|1.6261|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.6261|-0.6421|0.5759
71882704|NCT00531752|143284703|SUPERIORITY_OR_OTHER||LS Mean Difference|0.875|STANDARD_ERROR_OF_MEAN|0.9488||0.3603|TWO_SIDED|80.0|-0.3552|2.1051|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1051|-0.3552|0.3603
71879435|NCT00307151|143278713|SUPERIORITY_OR_OTHER||Risk Difference (RD)|21.5|||<|0.001|TWO_SIDED|95.0|11.2|31.8||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (\<12 months vs. \>=12 months) and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.|||31.8|11.2|<0.001
71879436|NCT03600142|143278724|NON_INFERIORITY|For WLHIV (n=55), chi-square tests were used to assess differences between conditions in the proportion of participants who were retained in HIV care at 3 months post enrollment.||||||0.963|||||||Chi-squared|||We were aware that our resources of time and funding would not be sufficient to detect a significant difference in the HIV care outcome, and that we would only be able to detect observational signals of impact. We aimed for a minimum of 50 WLHIV, which is considered an adequate sample to assess feasibility and acceptability in a pilot intervention study. Given an estimated 5% HIV prevalence among women presenting for ANC, this required us to enroll 1000 female participants.||||0.963
71879437|NCT02081534|143278767|SUPERIORITY|||||||0.012|||||||ANCOVA|||||||0.012
71879438|NCT01360554|143278787|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.933||||0.195|TWO_SIDED|95.0|0.797|1.093||One-sided P-value.|1-sided stratified log-rank test|Stratified by epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG).|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS, baseline ECOG as stratification factors.|||1.093|0.797|0.195
71879439|NCT01360554|143278788|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.037||||0.643|TWO_SIDED|95.0|0.848|1.268||One-sided P-value|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.268|0.848|0.643
71879440|NCT01360554|143278789|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.899||||0.069|TWO_SIDED|95.0|0.78|1.035||Stratified by EGFR status, KRAS status, and baseline ECOG.|1-sided stratified log-rank test|One-sided P-value|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.035|0.780|0.069
71879441|NCT01360554|143278790|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.057||||0.728|TWO_SIDED|95.0|0.881|1.267||One-sided P-value.|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.267|0.881|0.728
71879442|NCT01360554|143278791|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.026||||0.638|TWO_SIDED|95.0|0.887|1.188||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status, KRAS status, and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.|||1.188|0.887|0.638
71879443|NCT01360554|143278792|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.078||||0.775|TWO_SIDED|95.0|0.886|1.312||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.|||1.312|0.886|0.775
71879444|NCT01360554|143278800|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.9357||||||95.0|-4.278|0.407|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Global QoL. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||0.407|-4.278|
71879445|NCT01360554|143278800|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.8067||||||95.0|-1.312|2.926|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 cognitive functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.926|-1.312|
71879446|NCT01360554|143278800|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|0.73||||||95.0|-1.575|3.035|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 emotional functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.035|-1.575|
71879447|NCT01360554|143278800|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.5289||||||95.0|-0.756|3.814|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 physical functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.814|-0.756|
71879448|NCT01360554|143278800|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2219||||||95.0|-1.975|4.419|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 role functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.419|-1.975|
71882705|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5306|STANDARD_ERROR_OF_MEAN|1.6664||0.0392|TWO_SIDED|80.0|1.3659|5.6952|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.6952|1.3659|0.0392
71686361|NCT01483599|142890257|SUPERIORITY_OR_OTHER||Difference in Percentage|28.7|||||TWO_SIDED|95.0|8.5|49.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||49.0|8.5|
71686362|NCT01483599|142890257|SUPERIORITY_OR_OTHER||Difference in Percentage|32.9|||||TWO_SIDED|95.0|13.0|52.8||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).||52.8|13.0|
71879449|NCT01360554|143278800|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.497||||||95.0|-4.575|1.581|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 social functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.581|-4.575|
71879450|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|1.2851|||||TWO_SIDED|95.0|-2.416|4.986|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Appetite loss. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.986|-2.416|
71879451|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-5.923|||||TWO_SIDED|95.0|-8.432|-3.414|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Constipation. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-3.414|-8.432|
71879452|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|20.2564|||||TWO_SIDED|95.0|16.874|23.639|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Diarrhea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||23.639|16.874|
71879453|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.5499|||||TWO_SIDED|95.0|-7.719|-1.381|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Dysponea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.381|-7.719|
71879454|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.6584|||||TWO_SIDED|95.0|-4.442|1.125|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Fatigue. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.125|-4.442|
71879455|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.1469||||||95.0|-3.056|2.762|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Financial Difficulties. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.762|-3.056|
71882706|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9344|STANDARD_ERROR_OF_MEAN|1.7848||0.0003|TWO_SIDED|80.0|4.6177|9.2512|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.2512|4.6177|0.0003
71882707|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2888|STANDARD_ERROR_OF_MEAN|2.1861||0.0547|TWO_SIDED|80.0|1.4544|7.1232|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1232|1.4544|0.0547
71882708|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6799|STANDARD_ERROR_OF_MEAN|2.3261||0.0176|TWO_SIDED|80.0|2.6655|8.6943|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6943|2.6655|0.0176
71882709|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7203|STANDARD_ERROR_OF_MEAN|2.5085||0.775|TWO_SIDED|80.0|-2.53|3.9704|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9704|-2.530|0.7750
71686363|NCT01483599|142890258|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANOVA on the van Der Waerden score|||||||0.008
71686364|NCT01483599|142890258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71686365|NCT01483599|142890258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71686366|NCT01483599|142890258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71686367|NCT01483599|142890258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71686368|NCT01483599|142890258|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on the van Der Waerden score|||||||< 0.001
71686369|NCT00904917|142890288|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||t-test, 2 sided|||||||.015
71919476|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.078|||<|0.0001|TWO_SIDED|95.0|1.062|1.094|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.094|1.062|<0.0001
71919477|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.136||||0.0035|TWO_SIDED|95.0|1.819|20.701|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||20.701|1.819|0.0035
71686370|NCT00904917|142890290|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Regression, Linear|||||||.037
71919478|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.903||||0.7821|TWO_SIDED|95.0|0.439|1.857|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.857|0.439|0.7821
71919479|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.4846|TWO_SIDED|95.0|0.317|1.723|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.723|0.317|0.4846
71919480|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.424||||0.017|TWO_SIDED|95.0|1.353|21.749|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||21.749|1.353|0.0170
71919481|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.695||||0.0125|TWO_SIDED|95.0|0.523|0.925|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.925|0.523|0.0125
71919482|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.472||||0.0139|TWO_SIDED|95.0|1.288|9.357|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||9.357|1.288|0.0139
71919483|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.6327|TWO_SIDED|95.0|0.601|2.311|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (\> 1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.311|0.601|0.6327
71919484|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.061|||<|0.0001|TWO_SIDED|95.0|1.042|1.08|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.080|1.042|<0.0001
71919485|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.0033|TWO_SIDED|95.0|1.058|1.326|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.326|1.058|0.0033
71919486|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.227|||<|0.0001|TWO_SIDED|95.0|1.151|1.308|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.308|1.151|<0.0001
71686371|NCT05206734|142890293|OTHER||Hazard Ratio (HR)|1.28|||||TWO_SIDED|95.0|1.12|1.46|||||HR was calculated using a Cox Proportional Hazard model adjusted for age,sex,socioeconomic status, ethnicity and common childhood conditions. Reflects a comparison of the incidence rates between participants diagnosed with IBD and those without IBD.|||1.46|1.12|
71919487|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.814||||0.0289|TWO_SIDED|95.0|0.676|0.979|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, 1st 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.979|0.676|0.0289
71919488|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276|||<|0.0001|TWO_SIDED|95.0|1.177|1.383|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.383|1.177|<0.0001
71919489|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.894||||0.0099|TWO_SIDED|95.0|0.821|0.973|||Regression, Logistic|||The statistical analysis is presented for Cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.973|0.821|0.0099
71919490|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
71919491|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
71919492|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.945||||0.0058|TWO_SIDED|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||3.120|1.213|0.0058
71686372|NCT05206734|142890294|OTHER||Risk Ratio (RR)|1.82|||||TWO_SIDED|95.0|1.33|2.52|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.52|1.33|
71686373|NCT05206734|142890295|OTHER||Hazard Ratio (HR)|1.63|||||TWO_SIDED|95.0|1.02|2.62|||||HR calculated using Cox regression models adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.62|1.02|
71919493|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.262|||<|0.0001|TWO_SIDED|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.380|1.154|<0.0001
71919494|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.615||||0.0205|TWO_SIDED|95.0|1.219|10.721|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||10.721|1.219|0.0205
71919495|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.981||||0.9557|TWO_SIDED|95.0|0.506|1.903|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.903|0.506|0.9557
71919496|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.599||||0.2|TWO_SIDED|95.0|0.273|1.312|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.312|0.273|0.2000
71686374|NCT05206734|142890296|OTHER||Risk Ratio (RR)|2.78|||||TWO_SIDED|95.0|1.76|4.43|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||4.43|1.76|
71686375|NCT05206734|142890298|OTHER||Risk Ratio (RR)|1.33|||||TWO_SIDED|95.0|1.12|1.58|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||1.58|1.12|
71686376|NCT05206734|142890299|OTHER||Risk Ratio (RR)|1.87|||||TWO_SIDED|95.0|1.29|2.75|||||RR calculated using negative binomial model adjusted for age,sex,socioeconomic status,ethnicity,IBD type and comorbidities.Reflects a comparison of the incidence rate ratio between IBD participants diagnosed with and without mental health conditions.|||2.75|1.29|
71879456|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.8711|||||TWO_SIDED|95.0|-7.998|-1.745|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Insomnia. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.745|-7.998|
71879457|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.4924|||||TWO_SIDED|95.0|-2.485|1.5|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Nausea and Vomiting. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.500|-2.485|
71879458|NCT01360554|143278801|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.3096|||||TWO_SIDED|95.0|-2.646|3.265|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Pain. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||3.265|-2.646|
71879459|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|2.6381||||||95.0|0.172|5.104|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Trouble Swallowing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||5.104|0.172|
71879460|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-4.2504||||||95.0|-7.178|-1.322|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Coughing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||-1.322|-7.178|
71879461|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model|-1.0764||||||95.0|-3.997|1.845|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Haemoptysis as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.845|-3.997|
71879462|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|9.3545||||||95.0|6.211|12.497|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Sore Mouth as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||12.497|6.211|
71879463|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1762||||||95.0|-3.56|1.208|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Shortness of Breath as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.208|-3.560|
71879464|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.6378||||||95.0|-3.684|2.408|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Peripheral Neuropathy as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.408|-3.684|
71879465|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.3637||||||95.0|-4.546|1.819|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Alopecia as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.819|-4.546|
71879466|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.2163||||||95.0|-3.885|1.452|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Chest as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.452|-3.885|
71686377|NCT02330172|142890302|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71686378|NCT02330172|142890303|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71686379|NCT00734656|142890304|SUPERIORITY_OR_OTHER|||||||0.28||95.0|||||t-test, 2 sided|||null hypothesis - dutasteride does not affect blood alcohol following standardized dose of alcohol (0.8 gr/kg)||||0.28
71686380|NCT00734656|142890305|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the sedative effect of alcohol||||0.010
71686381|NCT00734656|142890306|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the stimulating effect of alcohol||||0.17
71879467|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.1475||||||95.0|-3.902|1.607|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Arm or Shoulder as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.607|-3.902|
71879468|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-1.0687||||||95.0|-4.488|2.351|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain Other Parts as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||2.351|-4.488|
71879469|NCT01360554|143278802|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|0.0322||||||95.0|-4.847|4.911|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Any Med for Pain as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||4.911|-4.847|
71879470|NCT01360554|143278803|SUPERIORITY_OR_OTHER||Repeated measures mixed-effects model.|-0.3886||||||95.0|-2.413|1.636|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for EQ-5D VAS. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.||1.636|-2.413|
71879471|NCT02113436|143278816|SUPERIORITY_OR_OTHER||Difference in Least square means|-0.97||||0.206|TWO_SIDED|95.0|-2.47|0.54|||ANCOVA|||||0.54|-2.47|0.206
71879472|NCT02113436|143278817|SUPERIORITY_OR_OTHER||Difference in Least sqaure means|-0.49||||0.235|TWO_SIDED|95.0|-1.29|0.32|||ANCOVA|||||0.32|-1.29|0.235
71879473|NCT02113436|143278818|SUPERIORITY_OR_OTHER||Difference in Least-Sqaure means|-0.48||||0.236|TWO_SIDED|95.0|-1.27|0.31|||ANCOVA|||||0.31|-1.27|0.236
71879474|NCT02113436|143278819|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47|||||TWO_SIDED|95.0|0.14|1.6||||||||1.60|0.14|
71879475|NCT02113436|143278820|SUPERIORITY_OR_OTHER||Difference in Least-Square Means|0.7||||0.041|TWO_SIDED|95.0|0.0|1.4|||ANCOVA|||||1.4|0.0|0.041
71879476|NCT02113436|143278821|SUPERIORITY_OR_OTHER||Difference in Least Square Means|-0.06||||0.335|TWO_SIDED|95.0|-0.2|0.07|||ANCOVA|||||0.07|-0.20|0.335
71879477|NCT02113436|143278822|SUPERIORITY_OR_OTHER||Difference in Least Square Means|2.6||||0.389|TWO_SIDED|95.0|-3.3|8.6|||ANCOVA|||||8.6|-3.3|0.389
71879478|NCT01111851|143278833|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS Means|1.0|||||TWO_SIDED|90.0|0.99|1.01|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.01|0.99|
71879479|NCT01111851|143278834|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.98|1.02|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.02|0.98|
71879480|NCT01111851|143278835|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|1.0|||||TWO_SIDED|90.0|0.97|1.03|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.03|0.97|
71879481|NCT01111851|143278836|SUPERIORITY_OR_OTHER||Geometric Mean Ratio of the LS means|0.91|||||TWO_SIDED|90.0|0.5|1.66|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \[aprepitant~165 mg/fosaprepitant 150 mg\]."|||1.66|0.50|
71879482|NCT01961349|143278839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71879483|NCT01961349|143278839|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71879484|NCT01961349|143278840|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71879485|NCT01961349|143278840|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71879486|NCT01299376|143278848|SUPERIORITY_OR_OTHER||Difference in Least-squares Means|-5.9|||<|0.001|TWO_SIDED|95.0|-7.5|-4.2|||Contrained Longitudinal Data Analysis|Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.||||-4.2|-7.5|<0.001
71879487|NCT01299376|143278859|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-10.3|||<|0.001|TWO_SIDED|95.0|-12.8|-7.7||Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|Constrained Longitudinal Data Analysis|||||-7.7|-12.8|<0.001
71879488|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.1|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.146|0.100|<0.0001
71882710|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04276|STANDARD_ERROR_OF_MEAN|2.6874||0.9874|TWO_SIDED|80.0|-3.521|3.4357|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.4357|-3.521|0.9874
71919497|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.684||||0.0437|TWO_SIDED|95.0|1.037|13.083|||Regression, Logistic|||The statistical analysis is presented for (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||13.083|1.037|0.0437
71919498|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|134.6|||<|0.0001|TWO_SIDED|95.0|17.956|1009.0|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1009.0|17.956|<0.0001
71919499|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|77.905|||<|0.0001|TWO_SIDED|95.0|10.521|576.85|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||576.85|10.521|<0.0001
71919500|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.527||||0.0105|TWO_SIDED|95.0|1.872|112.73|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||112.73|1.872|0.0105
71919501|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.563||||0.0041|TWO_SIDED|95.0|1.152|2.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.120|1.152|0.0041
71919502|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.557|||<|0.0001|TWO_SIDED|95.0|2.405|12.838|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||12.838|2.405|<0.0001
71919503|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.822||||0.0037|TWO_SIDED|95.0|1.216|2.732|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.732|1.216|0.0037
71919504|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.342|||<|0.0001|TWO_SIDED|95.0|3.977|32.347|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||32.347|3.977|<0.0001
71919505|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
71919506|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.112|||<|0.0001|TWO_SIDED|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||1.158|1.068|<0.0001
71922344|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.3|||||TWO_SIDED|95.0|1.17|4.53||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||4.53|1.17|
71922345|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.75|||||TWO_SIDED|95.0|1.18|6.36||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||6.36|1.18|
71922346|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07|||||TWO_SIDED|95.0|0.85|1.34||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM||1.34|0.85|
71922347|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.54|1.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM||1.42|0.54|
71922348|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.08|||||TWO_SIDED|95.0|0.76|1.52||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM||1.52|0.76|
71922349|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.74|1.43||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM||1.43|0.74|
71922350|NCT01682876|143365204|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.33|1.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||1.74|0.33|
71922351|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.43|||||TWO_SIDED|95.0|0.77|2.65||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM||2.65|0.77|
71686382|NCT00734656|142890307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||null hypothesis - A single 4 mg dose of dutasteride does not reduce serum 3a-androstanediol glucuronide levels||||<0.001
71686383|NCT02085070|142890344|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% response|29.7|||||TWO_SIDED|95.0|15.9|47.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from NSCLC. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||47.0|15.9|
71686384|NCT02085070|142890344|SUPERIORITY|A response of \> 10% of patients was defined as superior.|% of patients|26.0|||||TWO_SIDED|95.0|10.0|48.0||||||Each group was assessed individually. The primary goal of this study is to determine the efficacy of MK-3475 in patients with untreated brain metastases from melanoma. The primary endpoint is the brain metastasis response rate (BMRR). A drug with minimal activity would be expected to have a BMRR of 10%.||48.0|10.0|
71686385|NCT02769312|142890346|OTHER||Effect size (cohen's d)|0.16||||0.46|TWO_SIDED||||||ANCOVA|||||||0.46
71686386|NCT02769312|142890347|SUPERIORITY||Effect size (cohen's d)|0.12||||0.61|TWO_SIDED||||||ANCOVA|||||||0.61
71686387|NCT02769312|142890348|SUPERIORITY||Effect size (cohen's d)|0.39||||0.04|TWO_SIDED||||||ANCOVA|||||||.04
71879489|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.117|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001||95.0|0.094|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.140|0.094|<0.0001
71686388|NCT02178358|142890349|SUPERIORITY||Hazard Ratio (HR)|0.776||||0.837|TWO_SIDED|95.0|0.434|1.226|||Bayesian exponential-likelihood model|||||1.226|0.434|0.837
71686389|NCT02178358|142890349|SUPERIORITY||Hazard Ratio (HR)|0.917||||0.704|TWO_SIDED|95.0|0.633|1.266|||Bayesian exponential-likelihood model|||||1.266|0.633|0.704
71686390|NCT03539484|142890369|OTHER|A Bayesian approach is used to estimate the maximum tolerated dose (MTD).|Posterior probability at dose 1.8 mg|10.6|||||TWO_SIDED|95.0|2.1|26.5||There is no p-value derived; logistic regression is used to estimate the probability of DLT.|Regression, Logistic|||||26.5|2.10|
71686391|NCT00560703|142890401|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis||||||0.578||95.0|||||ANCOVA|||||||0.578
71879490|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.086|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.132|0.086|<0.0001
71879491|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.093|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.07|0.116||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.116|0.070|<0.0001
71879492|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.102|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.08|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.080|<0.0001
71686392|NCT00560703|142890402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.293||95.0|||||ANCOVA|||It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.||||0.293
71686393|NCT03077607|142890415|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|139.92|||||TWO_SIDED|90.0|113.26|172.87||||||Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)||172.87|113.26|
71879493|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2169|TWO_SIDED|95.0|-0.008|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.037|-0.008|0.2169
71879494|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.13||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.130|0.085|<0.0001
71879495|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.006|STANDARD_ERROR_OF_MEAN|0.012||0.5849|TWO_SIDED|95.0|-0.017|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.017|0.5849
71879496|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1863|TWO_SIDED|95.0|-0.007|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.007|0.1863
71879497|NCT01431274|143278883|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4352|TWO_SIDED|95.0|-0.032|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.014|-0.032|0.4352
71879498|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.082|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.106||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.106|0.059|<.0001
71879499|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.047|<0.0001
71879500|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.081|0.034|<0.0001
71879501|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0174|TWO_SIDED|95.0|0.005|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.052|0.005|0.0174
71879502|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
71879503|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0407|TWO_SIDED|95.0|0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|0.001|0.0407
71879504|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.03|0.077||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.077|0.030|<0.0001
71922352|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.49|||||TWO_SIDED|95.0|0.81|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM||2.74|0.81|
71922353|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.27|||||TWO_SIDED|95.0|1.04|1.55||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM||1.55|1.04|
71922354|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.81|||||TWO_SIDED|95.0|0.98|3.33||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM||3.33|0.98|
71922355|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.77|2.17||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM||2.17|0.77|
71922356|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.65|||||TWO_SIDED|95.0|1.06|2.57||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM||2.57|1.06|
71922357|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.37|||||TWO_SIDED|95.0|0.99|1.89||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM||1.89|0.99|
71922358|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.07|||||TWO_SIDED|95.0|0.97|4.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM||4.42|0.97|
71922359|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.83|||||TWO_SIDED|95.0|1.22|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM||2.74|1.22|
71922360|NCT01682876|143365205|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.14|||||TWO_SIDED|95.0|0.48|2.68||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM||2.68|0.48|
71922361|NCT03852901|143365208|OTHER||Mean Difference (Final Values)|40.717|STANDARD_ERROR_OF_MEAN|4.866|<|0.001|TWO_SIDED|95.0|31.166|50.268||Type III of fixed effects. Num df = 1; Den df = 902.758; F = 70.003; Sig. \< 0.001 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||50.268|31.166|<0.001
71922362|NCT03852901|143365209|OTHER||Mean Difference (Final Values)|-0.637|STANDARD_ERROR_OF_MEAN|1.051||0.545|TWO_SIDED|95.0|-2.699|1.426||Type III of fixed effects. Num df = 1; Den df = 884.229; F = .367; Sig = .545 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||1.426|-2.699|0.545
71922363|NCT03852901|143365210|OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.009||0.003|TWO_SIDED|95.0|0.009|0.044||Type III of fixed effects. Num df = 1; Den df = 880.629; F = 8.782; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||.044|.009|0.003
71922364|NCT03852901|143365211|OTHER||Mean Difference (Final Values)|-2.647|STANDARD_ERROR_OF_MEAN|1.329||0.047|TWO_SIDED|95.0|-5.255|-0.04||Type III of fixed effects. Num df = 1; Den df = 880.870; F = 3.970; Sig. = 0.047 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-0.040|-5.255|0.047
71922365|NCT03852901|143365212|OTHER||Mean Difference (Final Values)|-5.573|STANDARD_ERROR_OF_MEAN|1.853||0.003|TWO_SIDED|95.0|-9.21|-1.937||Type III of fixed effects. Num df = 1; Den df = 902.181; F = 9.049; Sig. = 0.003 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit \& Timepoint; Fixed effects: repeated-measures. Visit, Timepoint, Sex, Visit\*Sex||No a-priori power calculation was performed due to the exploratory nature of the study.||-1.937|-9.210|0.003
71922366|NCT03852901|143365213|OTHER|||||||0.5849||||||Type III of fixed effects. Num df: 2; Den df = 33; F = 0.5451; Sig. = 0.5849 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.5849
71922367|NCT03852901|143365214|OTHER|||||||0.0142||||||Type III of fixed effects. Num df = 2; Den df = 35; F = 4.8191; Sig. = 0.0142 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effect: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age, fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.0142
71922368|NCT03852901|143365215|OTHER|||||||0.024||||||Type III of fixed effects. Num df: 2; Den df = 34; F = 4.1501; Sig. = 0.0244 (threshold for statistical significance p \< 0.05)|Mixed Models Analysis|Random effects: ID; Repeated measures: Visit; Fixed effects: Visit, Sex, Age and fCSF||No a-priori power calculation was performed due to the exploratory nature of the study.||||0.024
71922369|NCT02534324|143365217|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
71922370|NCT02534324|143365218|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||t-test, 2 sided|||||||0.15
71922371|NCT01138995|143365219|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher's combination test|Between group difference for entire sample||||||0.75
71922372|NCT01138995|143365220|SUPERIORITY_OR_OTHER||||||<|0.022|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.022
71922373|NCT01138995|143365221|SUPERIORITY_OR_OTHER||||||<|0.001|ONE_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71922374|NCT04259749|143365233|OTHER||Odds Ratio (OR)|1.4|||||TWO_SIDED|95.0|0.58|3.4|||||Adjusted for age, education, lifetime use of tobacco products.|||3.40|0.58|
71922375|NCT04259749|143365233|OTHER||Odds Ratio (OR)|2.28|||||TWO_SIDED|95.0|0.92|5.63|||||Adjusted for age, education, and lifetime use of tobacco products|||5.63|0.92|
71919507|NCT01066819|143360944|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.921||||0.0035|TWO_SIDED|95.0|1.686|14.362|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.||14.362|1.686|0.0035
71919508|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
71919509|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
71919510|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for Alanine Aminotransferase (ALT) ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
71919511|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
71919512|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
71919513|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.441||||0.0162|TWO_SIDED|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.859|0.226|0.0162
71919514|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.745||||0.0156|TWO_SIDED|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.741|1.111|0.0156
71919515|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.1075|TWO_SIDED|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\<=1 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||6.789|0.829|0.1075
71919516|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.906||||0.8518|TWO_SIDED|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (\> 1 - 3 vs \> 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||2.559|0.321|0.8518
71919517|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.969||||0.0012|TWO_SIDED|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.988|0.951|0.0012
71919518|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
71919519|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.848||||0.0017|TWO_SIDED|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.940|0.765|0.0017
71922376|NCT04259749|143365234|OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.61|4.07|||||Adjusted for age, education, and lifetime use of tobacco products|||4.07|0.61|
71922377|NCT04259749|143365234|OTHER||Odds Ratio (OR)|3.45|||||TWO_SIDED|95.0|1.32|9.02|||||Adjusted for age, education, and lifetime use of tobacco products|||9.02|1.32|
71922378|NCT04259749|143365235|OTHER||Odds Ratio (OR)|1.48|||||TWO_SIDED|95.0|0.59|3.68|||||Adjusted for age, education, and lifetime use of tobacco|||3.68|.59|
71922379|NCT04259749|143365235|OTHER||Odds Ratio (OR)|2.6|||||TWO_SIDED|95.0|1.05|6.42|||||Adjusted for age, education, and lifetime use of tobacco products.|||6.42|1.05|
71919520|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.401||||0.0071|TWO_SIDED|95.0|0.206|0.78|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.780|0.206|0.0071
71919521|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.016||||0.0006|TWO_SIDED|95.0|0.001|0.169|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.169|0.001|0.0006
71919522|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.076||||0.0255|TWO_SIDED|95.0|0.008|0.729|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||0.729|0.008|0.0255
71919523|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.184||||0.1501|TWO_SIDED|95.0|0.018|1.845|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||1.845|0.018|0.1501
71919524|NCT01066819|143360961|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|27.25|||<|0.0001|TWO_SIDED|95.0|6.729|110.35|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs RVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.||110.35|6.729|<0.0001
71919525|NCT00805194|143360969|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.0019|TWO_SIDED|95.0|0.68|0.92|||Regression, Cox||Hazard Ratio (HR) below 1 favors nintedanib|HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)||0.92|0.68|0.0019
71919526|NCT00805194|143360970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.0073|TWO_SIDED|95.0|0.6|0.92||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma and \<9 months since start of first line therapy."||0.92|0.60|0.0073
71919527|NCT00805194|143360970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0359|TWO_SIDED|95.0|0.7|0.99||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma."||0.99|0.70|0.0359
71919528|NCT00805194|143360970|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.272|TWO_SIDED|95.0|0.83|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||The overall alpha level followed a Lan-DeMets spending function with O'Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for all patients."||1.05|0.83|0.2720
71919529|NCT00805194|143360971|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.007|TWO_SIDED|95.0|0.75|0.96||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.96|0.75|0.0070
71919530|NCT00805194|143360972|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0012|TWO_SIDED|95.0|0.73|0.93||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||0.93|0.73|0.0012
71919531|NCT00805194|143360973|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3067|TWO_SIDED|95.0|0.76|2.39||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.39|0.76|0.3067
71686394|NCT03077607|142890416|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|150.71|||||TWO_SIDED|90.0|136.47|166.43||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||166.43|136.47|
71922380|NCT04259749|143365236|OTHER||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.47|2.49|||||Adjusted for age, education, and lifetime use of tobacco|||2.49|.47|
71882711|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6252|STANDARD_ERROR_OF_MEAN|2.2268||0.7799|TWO_SIDED|80.0|-3.513|2.2629|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.2629|-3.513|0.7799
71882712|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1136|STANDARD_ERROR_OF_MEAN|2.3365||0.1881|TWO_SIDED|80.0|0.08338|6.1438|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1438|0.08338|0.1881
71882713|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6575|STANDARD_ERROR_OF_MEAN|1.9677||0.4032|TWO_SIDED|80.0|-0.8944|4.2094|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2094|-0.8944|0.4032
71882714|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|5.9254|STANDARD_ERROR_OF_MEAN|2.0796||0.0059|TWO_SIDED|80.0|3.2314|8.6193|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6193|3.2314|0.0059
71919532|NCT00805194|143360973|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.0761|TWO_SIDED|95.0|0.96|2.08||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment||2.08|0.96|0.0761
71919533|NCT00805194|143360976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68|||<|0.0001|TWO_SIDED|95.0|1.35|2.09||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on the central independent review||2.09|1.35|<0.0001
71919534|NCT00805194|143360976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64|||<|0.0001|TWO_SIDED|95.0|1.31|2.05||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio \>1 indicates a benefit to nintedanib|Analysis based on investigator's assessment||2.05|1.31|<0.0001
71919535|NCT00805194|143360978|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review||||<0.0001
71919536|NCT00805194|143360978|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment||||<0.0001
71919537|NCT00805194|143360979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.7282|TWO_SIDED|95.0|0.87|1.21||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|||1.21|0.87|0.7282
71919538|NCT00805194|143360980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.1858|TWO_SIDED|95.0|0.77|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough||1.05|0.77|0.1858
71919539|NCT00805194|143360980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05||||0.5203|TWO_SIDED|95.0|0.91|1.2||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea||1.20|0.91|0.5203
71919540|NCT00805194|143360980|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95||||0.4373|TWO_SIDED|95.0|0.82|1.09||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs \>= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain||1.09|0.82|0.4373
71919541|NCT02275052|143360992|SUPERIORITY_OR_OTHER||Least squares mean difference|3.31||||0.79|TWO_SIDED|95.0|-21.12|27.74||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||27.74|-21.12|0.790
71919542|NCT02275052|143360993|SUPERIORITY_OR_OTHER||Least squares mean difference|0.206|||<|0.001|TWO_SIDED|95.0|0.167|0.246|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.246|0.167|<0.001
71919543|NCT02275052|143360994|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.346|||<|0.001|TWO_SIDED|95.0|-0.487|-0.204|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||-0.204|-0.487|<0.001
71919544|NCT02275052|143360995|SUPERIORITY_OR_OTHER||Least squares mean difference|0.259|||<|0.001|TWO_SIDED|95.0|0.194|0.324|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.|||0.324|0.194|<0.001
71919545|NCT01143116|143360996|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
71919546|NCT01143116|143360996|OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
71919547|NCT01143116|143360997|OTHER|||||||0.875|||||||Wilcoxon (Mann-Whitney)|||||||0.8750
71919548|NCT01143116|143360997|OTHER|||||||0.625|||||||Wilcoxon (Mann-Whitney)|||||||0.6250
71919549|NCT01143116|143360998|OTHER|||||||0.0254|||||||Wilcoxon (Mann-Whitney)|||||||0.0254
71919550|NCT01143116|143360998|OTHER|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
71919551|NCT01143116|143360999|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71919552|NCT01143116|143360999|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71919553|NCT01143116|143361000|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0
71919554|NCT01143116|143361000|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71919555|NCT01143116|143361001|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71919556|NCT01143116|143361002|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71919557|NCT01143116|143361003|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71919558|NCT01143116|143361003|OTHER|||||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
71919559|NCT01143116|143361004|OTHER|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
71919560|NCT01143116|143361004|OTHER|||||||0.6406|||||||Wilcoxon (Mann-Whitney)|||||||0.6406
71919561|NCT01143116|143361005|OTHER|||||||0.4375|||||||Wilcoxon (Mann-Whitney)|||||||0.4375
71919562|NCT01143116|143361005|OTHER|||||||0.2969|||||||Wilcoxon (Mann-Whitney)|||||||0.2969
71919563|NCT01143116|143361006|OTHER|||||||0.5391|||||||Wilcoxon (Mann-Whitney)|||||||0.5391
71919564|NCT01143116|143361006|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.0010
71919565|NCT01143116|143361007|OTHER|||||||0.4766|||||||Wilcoxon (Mann-Whitney)|||||||0.4766
71919566|NCT01143116|143361007|OTHER|||||||0.0068|||||||Wilcoxon (Mann-Whitney)|||||||0.0068
71919567|NCT01143116|143361008|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71919568|NCT01143116|143361008|OTHER|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||||||0.4180
71919569|NCT00808028|143361018|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71919570|NCT00808028|143361018|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0007
71922381|NCT04259749|143365236|OTHER||Odds Ratio (OR)|1.43|||||TWO_SIDED|95.0|0.62|3.31|||||Adjusted for age, education, and lifetime use of tobacco products|||3.31|.62|
71922382|NCT04259749|143365237|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime use of tobacco products|||4.14|.72|
71922383|NCT04259749|143365237|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime use of tobacco products.|||4.95|.83|
71922384|NCT04259749|143365238|OTHER||Odds Ratio (OR)|1.13|||||TWO_SIDED|95.0|0.4|3.18|||||Adjusted for age, education, and lifetime tobacco use|||3.18|.40|
71922385|NCT04259749|143365238|OTHER||Odds Ratio (OR)|2.04|||||TWO_SIDED|95.0|0.73|5.71|||||Adjusted for age, education, and lifetime tobacco use|||5.71|.73|
71922386|NCT04259749|143365239|OTHER||Odds Ratio (OR)|1.77|||||TWO_SIDED|95.0|0.66|4.75|||||Adjusted for age, education, and lifetime tobacco use|||4.75|.66|
71922387|NCT04259749|143365239|OTHER||Odds Ratio (OR)|3.06|||||TWO_SIDED|95.0|1.13|8.29|||||Adjusted for age, education, and lifetime use of tobacco|||8.29|1.13|
71922388|NCT04259749|143365240|OTHER||Odds Ratio (OR)|1.38|||||TWO_SIDED|95.0|0.51|3.7|||||Adjusted for age, education, and lifetime tobacco use|||3.70|.51|
71922389|NCT04259749|143365240|OTHER||Odds Ratio (OR)|2.32|||||TWO_SIDED|95.0|0.85|6.31|||||Adjusted for age, education, and lifetime tobacco use|||6.31|.85|
71922390|NCT04259749|143365241|OTHER||Odds Ratio (OR)|1.11|||||TWO_SIDED|95.0|0.29|4.26|||||Adjusted for age, education, and lifetime tobacco use|||4.26|.29|
71922391|NCT04259749|143365241|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.57|7.06|||||Adjusted for age, education, and lifetime tobacco use|||7.06|.57|
71922392|NCT04259749|143365242|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.33|3.31|||||Adjusted for age, education, and lifetime tobacco use|||3.31|.33|
71922393|NCT04259749|143365242|OTHER||Odds Ratio (OR)|2.43|||||TWO_SIDED|0.95|0.83|7.13|||||Adjusted for age, education, and lifetime tobacco use|||7.13|.83|
71922394|NCT04259749|143365243|OTHER||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.72|4.14|||||Adjusted for age, education, and lifetime tobacco use|||4.14|.72|
71922395|NCT04259749|143365243|OTHER||Odds Ratio (OR)|2.03|||||TWO_SIDED|95.0|0.83|4.95|||||Adjusted for age, education, and lifetime tobacco use|||4.95|.83|
71922396|NCT00303602|143365244|SUPERIORITY_OR_OTHER|||||||0.428||95.0||||P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.428
71922397|NCT00303602|143365244|SUPERIORITY_OR_OTHER|||||||0.859||95.0||||P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.859
71922398|NCT00303602|143365244|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.885
71922399|NCT00303602|143365244|SUPERIORITY_OR_OTHER|||||||0.784||95.0||||P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis|||||||0.784
71922400|NCT00303602|143365244|SUPERIORITY_OR_OTHER|||||||0.465||95.0||||P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons|Mixed Models Analysis|||||||0.465
71922401|NCT00303602|143365245|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.19||||0.442||95.0|-0.67|0.3|||ANCOVA||Change = Endpoint minus baseline|||0.30|-0.67|0.442
71922402|NCT00303602|143365246|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|-0.32||||0.328||95.0|-0.95|0.32|||ANCOVA||Change = Endpoint minus baseline|||0.32|-0.95|0.328
71922403|NCT00303602|143365247|SUPERIORITY_OR_OTHER|||||||0.385||95.0|||||Mixed Models Analysis|||||||0.385
71922404|NCT00303602|143365248|SUPERIORITY_OR_OTHER||Least Square Mean Change Difference|0.1||||0.914||95.0|-1.65|1.84|||ANCOVA||Change = endpoint minus baseline|||1.84|-1.65|0.914
71922405|NCT00303602|143365249|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||Up to Week 16 p-value|Fisher Exact|||||||0.325
71922406|NCT00303602|143365251|SUPERIORITY_OR_OTHER|||||||0.344||95.0|||||Mixed Models Analysis|||||||0.344
71922407|NCT00303602|143365252|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||Systolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.708
71922408|NCT00303602|143365252|SUPERIORITY_OR_OTHER|||||||0.453||95.0||||Diastolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test|||||||0.453
71922409|NCT00303602|143365253|SUPERIORITY_OR_OTHER|||||||0.187||95.0||||Total Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.187
71922410|NCT00303602|143365253|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||High-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.163
71922411|NCT00303602|143365253|SUPERIORITY_OR_OTHER|||||||0.323||95.0||||Low-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.323
71922412|NCT00303602|143365253|SUPERIORITY_OR_OTHER|||||||0.581||95.0||||Triglycerides Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.581
71922413|NCT00303602|143365254|SUPERIORITY_OR_OTHER|||||||0.227||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.227
71882715|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0921|STANDARD_ERROR_OF_MEAN|2.1098||0.6067|TWO_SIDED|80.0|-1.643|3.8273|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8273|-1.643|0.6067
71882716|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|4.2785|STANDARD_ERROR_OF_MEAN|2.2424||0.0614|TWO_SIDED|80.0|1.3709|7.186|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.1860|1.3709|0.0614
71882717|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7149|STANDARD_ERROR_OF_MEAN|2.2086||0.7476|TWO_SIDED|80.0|-3.584|2.1546|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.1546|-3.584|0.7476
71882718|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3355|STANDARD_ERROR_OF_MEAN|2.4396||0.5863|TWO_SIDED|80.0|-4.499|1.8284|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.8284|-4.499|0.5863
71882719|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1058|STANDARD_ERROR_OF_MEAN|2.0529||0.9591|TWO_SIDED|80.0|-2.771|2.5593|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.5593|-2.771|0.9591
71882720|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4352|STANDARD_ERROR_OF_MEAN|2.2048||0.8442|TWO_SIDED|80.0|-3.294|2.4238|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||2.4238|-3.294|0.8442
71882721|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6876|STANDARD_ERROR_OF_MEAN|2.0533||0.1977|TWO_SIDED|80.0|0.01391|5.3613|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.3613|0.01391|0.1977
71882722|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|1.8149|STANDARD_ERROR_OF_MEAN|2.2467||0.4235|TWO_SIDED|80.0|-1.108|4.7375|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.7375|-1.108|0.4235
71882723|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|2.6424|STANDARD_ERROR_OF_MEAN|1.9753||0.1882|TWO_SIDED|80.0|0.07015|5.2147|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2147|0.07015|0.1882
71882724|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2105|STANDARD_ERROR_OF_MEAN|2.0376||0.5555|TWO_SIDED|80.0|-1.44|3.8615|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.8615|-1.440|0.5555
71882725|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|3.1804|STANDARD_ERROR_OF_MEAN|2.1934||0.1533|TWO_SIDED|80.0|0.33169|6.0292|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0292|0.33169|0.1533
71882726|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0511|STANDARD_ERROR_OF_MEAN|2.2662||0.3697|TWO_SIDED|80.0|-0.8912|4.9934|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.9934|-0.8912|0.3697
71882727|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|1.764|STANDARD_ERROR_OF_MEAN|2.3939||0.4652|TWO_SIDED|80.0|-1.352|4.8801|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.8801|-1.352|0.4652
71882728|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4377|STANDARD_ERROR_OF_MEAN|2.5148||0.8626|TWO_SIDED|80.0|-2.83|3.7058|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.7058|-2.830|0.8626
71882729|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7114|STANDARD_ERROR_OF_MEAN|1.6168||0.0261|TWO_SIDED|80.0|1.6105|5.8122|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.8122|1.6105|0.0261
71882730|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|2.2644|STANDARD_ERROR_OF_MEAN|1.7026||0.1895|TWO_SIDED|80.0|0.0533|4.4756|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.4756|0.05330|0.1895
71882731|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1151|STANDARD_ERROR_OF_MEAN|3.0732||0.4994|TWO_SIDED|80.0|-1.961|6.1913|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.1913|-1.961|0.4994
71882732|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|3.5616|STANDARD_ERROR_OF_MEAN|3.3113||0.2945|TWO_SIDED|80.0|-0.8226|7.9458|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.9458|-0.8226|0.2945
71882733|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7306|STANDARD_ERROR_OF_MEAN|2.9257||0.8056|TWO_SIDED|80.0|-4.622|3.1613|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1613|-4.622|0.8056
71882734|NCT00531752|143284704|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3672|STANDARD_ERROR_OF_MEAN|3.8657||0.3922|TWO_SIDED|80.0|-1.725|8.4592|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.4592|-1.725|0.3922
71882735|NCT00531752|143284705|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.5069|STANDARD_ERROR_OF_MEAN|0.8744||0.0913|TWO_SIDED|80.0|-2.643|-0.3705|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3705|-2.643|0.0913
71919571|NCT00808028|143361018|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71919572|NCT00808028|143361018|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71919573|NCT00808028|143361018|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71919574|NCT00808028|143361018|SUPERIORITY_OR_OTHER|||||||0.0392|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0392
71919575|NCT00808028|143361018|SUPERIORITY_OR_OTHER|||||||0.0225|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0225
71919576|NCT00808028|143361018|SUPERIORITY_OR_OTHER|||||||0.0244|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0244
71919577|NCT00808028|143361019|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71686395|NCT03077607|142890417|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|156.24|||||TWO_SIDED|90.0|137.58|177.42||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||177.42|137.58|
71919578|NCT00808028|143361019|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0004
71919579|NCT00808028|143361019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71919580|NCT00808028|143361019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71919581|NCT00808028|143361019|SUPERIORITY_OR_OTHER||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||>0.9999
71882736|NCT00531752|143284705|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2078|STANDARD_ERROR_OF_MEAN|0.9165||0.8216|TWO_SIDED|80.0|-1.399|0.98326|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.98326|-1.399|0.8216
71882737|NCT00531752|143284706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4181|STANDARD_ERROR_OF_MEAN|0.6887||0.5466|TWO_SIDED|80.0|-1.313|0.47668|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.47668|-1.313|0.5466
71882738|NCT00531752|143284706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.02518|STANDARD_ERROR_OF_MEAN|0.6772||0.9705|TWO_SIDED|80.0|-0.9035|0.85312|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.85312|-0.9035|0.9705
71882739|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.09953|STANDARD_ERROR_OF_MEAN|0.3001||0.7415|TWO_SIDED|80.0|-0.4892|0.29012|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29012|-0.4892|0.7415
71882740|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04804|STANDARD_ERROR_OF_MEAN|0.3227||0.8822|TWO_SIDED|80.0|-0.3703|0.4664|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46640|-0.3703|0.8822
71882741|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.125|STANDARD_ERROR_OF_MEAN|0.1302||0.3414|TWO_SIDED|80.0|-0.0439|0.29385|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29385|-0.0439|0.3414
71882742|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1044|STANDARD_ERROR_OF_MEAN|0.1418||0.4642|TWO_SIDED|80.0|-0.0793|0.28814|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.28814|-0.0793|0.4642
71882743|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06109|STANDARD_ERROR_OF_MEAN|0.09093||0.5049|TWO_SIDED|80.0|-0.0571|0.17926|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.17926|-0.0571|0.5049
71882744|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07917|STANDARD_ERROR_OF_MEAN|0.1002||0.4332|TWO_SIDED|80.0|-0.051|0.2093|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.20930|-0.0510|0.4332
71882745|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2453|STANDARD_ERROR_OF_MEAN|0.1753||0.1678|TWO_SIDED|80.0|-0.473|-0.0177|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0177|-0.4730|0.1678
71882746|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07717|STANDARD_ERROR_OF_MEAN|0.1925||0.6901|TWO_SIDED|80.0|-0.1726|0.32695|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.32695|-0.1726|0.6901
71882747|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1702|STANDARD_ERROR_OF_MEAN|1.354||0.9005|TWO_SIDED|80.0|-1.587|1.9274|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.9274|-1.587|0.9005
71882748|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.4317|STANDARD_ERROR_OF_MEAN|1.4667||0.333|TWO_SIDED|80.0|-3.333|0.46937|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46937|-3.333|0.3330
71882749|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6537|STANDARD_ERROR_OF_MEAN|2.0857||0.7551|TWO_SIDED|80.0|-2.051|3.3584|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.3584|-2.051|0.7551
71882750|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8639|STANDARD_ERROR_OF_MEAN|2.2354||0.0334|TWO_SIDED|80.0|-7.759|-1.968|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.968|-7.759|0.0334
71882751|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6389|STANDARD_ERROR_OF_MEAN|3.6119||0.6519|TWO_SIDED|80.0|-3.05|6.3281|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3281|-3.050|0.6519
71882752|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2007|STANDARD_ERROR_OF_MEAN|3.9647||0.7631|TWO_SIDED|80.0|-3.941|6.3423|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.3423|-3.941|0.7631
71882753|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9211|STANDARD_ERROR_OF_MEAN|2.8206||0.3034|TWO_SIDED|80.0|-0.7227|6.5648|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5648|-0.7227|0.3034
71882754|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0968|STANDARD_ERROR_OF_MEAN|3.0022||0.0933|TWO_SIDED|80.0|-8.975|-1.218|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.218|-8.975|0.0933
71882755|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.0675|STANDARD_ERROR_OF_MEAN|2.9778||0.0949|TWO_SIDED|80.0|-8.934|-1.201|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.201|-8.934|0.0949
71919582|NCT00808028|143361019|SUPERIORITY_OR_OTHER|||||||0.0036|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||0.0036
71919583|NCT00808028|143361019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71919584|NCT00808028|143361019|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (\>) 50% of participants had fold rise \>=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value \< 0.025 was considered significant.||||<0.0001
71919585|NCT00750867|143361053|SUPERIORITY_OR_OTHER|||||||0.0128||||||The P-Value was obtained by comparing the UMSARS-I scores at final visit and at baseline.|ANOVA|||||||0.0128
71919586|NCT00750867|143361053|SUPERIORITY_OR_OTHER|||||||0.025||||||The P-Value was obtained by comparing the UMSARS-II scores at final visit and at baseline.|ANOVA|||||||0.025
71919587|NCT00779116|143361060|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.||||<0.0001
71919588|NCT00266799|143361072|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.08||||0.6686|TWO_SIDED|95.0|0.76|1.54|||Log Rank|||By Investigator Assessment of ITT Population||1.54|0.76|0.6686
71919589|NCT00266799|143361072|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.15||||0.4472|TWO_SIDED|95.0|0.8|1.65|||Log Rank|||By RECIST Criteria of ITT Population||1.65|0.80|0.4472
71919590|NCT00266799|143361072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.14||||0.5508|TWO_SIDED|95.0|0.74|1.77|||Log Rank|||By Investigator Assessment of TTP Population||1.77|0.74|0.5508
71919591|NCT00266799|143361072|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.21||||0.4088|TWO_SIDED|95.0|0.77|1.89|||Log Rank|||By RECIST Criteria of TTP Population||1.89|0.77|0.4088
71919592|NCT00266799|143361073|SUPERIORITY_OR_OTHER|||||||0.1726||95.0|||||Chi-squared|||By Investigator Assessment||||0.1726
71919593|NCT00266799|143361073|SUPERIORITY_OR_OTHER|||||||0.6541||95.0|||||Chi-squared|||By RECIST Criteria||||0.6541
71919594|NCT00266799|143361074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.12||||0.5265|TWO_SIDED|95.0|0.79|1.58|||Log Rank|||||1.58|0.79|0.5265
71919595|NCT00266799|143361075|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.29||||0.0841||95.0|||||Log Rank|p-value also given for Hazard Ratio||||||0.0841
71919596|NCT00242710|143361084|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|2.37|||<|0.001|TWO_SIDED|95.0|1.56|3.18|||ANCOVA|||An analysis of covariance (ANCOVA) model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.18|1.56|<0.001
71919597|NCT00242710|143361084|SUPERIORITY_OR_OTHER||LS Mean Difference|2.36|||<|0.001|TWO_SIDED|95.0|1.56|3.17|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.17|1.56|<0.001
71919598|NCT00242710|143361084|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78|||<|0.001|TWO_SIDED|95.0|2.81|4.76|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.76|2.81|<0.001
71919599|NCT00242710|143361086|SUPERIORITY_OR_OTHER||LS Mean Difference|1.61|||<|0.001|TWO_SIDED|95.0|0.97|2.24|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.24|0.97|<0.001
71919600|NCT00242710|143361086|SUPERIORITY_OR_OTHER||LS Mean Difference|1.82|||<|0.001|TWO_SIDED|95.0|1.19|2.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.46|1.19|<0.001
71919601|NCT00242710|143361086|SUPERIORITY_OR_OTHER||LS Mean Difference|2.46|||<|0.001|TWO_SIDED|95.0|1.69|3.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.23|1.69|<0.001
71919602|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.66||||0.373|TWO_SIDED|95.0|-0.8|2.12|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.12|-0.80|0.373
71919603|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.35||||0.738|TWO_SIDED|95.0|-1.7|2.4|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.40|-1.70|0.738
71919604|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.65||||0.539|TWO_SIDED|95.0|-1.41|2.71|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.71|-1.41|0.539
71919605|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.233|TWO_SIDED|95.0|-0.71|2.9|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.90|-0.71|0.233
71919606|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.605|TWO_SIDED|95.0|-1.39|2.39|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.39|-1.39|0.605
71919607|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.23||||0.305|TWO_SIDED|95.0|-1.12|3.57|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.57|-1.12|0.305
71919608|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.22||||0.299|TWO_SIDED|95.0|-1.08|3.52|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.52|-1.08|0.299
71919609|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.62||||0.092|TWO_SIDED|95.0|-0.27|3.51|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.51|-0.27|0.092
71919610|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.55||||0.08|TWO_SIDED|95.0|-0.18|3.29|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.29|-0.18|0.080
71919611|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.04||||0.279|TWO_SIDED|95.0|-0.85|2.92|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.92|-0.85|0.279
71919612|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.13||||0.26|TWO_SIDED|95.0|-0.84|3.11|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.11|-0.84|0.260
71686396|NCT03077607|142890418|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|136.62|||||TWO_SIDED|90.0|103.2|180.87||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||180.87|103.20|
71919613|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.618|TWO_SIDED|95.0|-1.5|2.52|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.52|-1.50|0.618
71919614|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.41||||0.81|TWO_SIDED|95.0|-3.78|2.96|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.96|-3.78|0.810
71919615|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.654|TWO_SIDED|95.0|-1.14|1.81|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.81|-1.14|0.654
71919616|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.22||||0.834|TWO_SIDED|95.0|-1.84|2.28|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.28|-1.84|0.834
71919617|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34||||0.744|TWO_SIDED|95.0|-2.41|1.72|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.72|-2.41|0.744
71919618|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.909|TWO_SIDED|95.0|-1.7|1.91|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.91|-1.70|0.909
71919619|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.963|TWO_SIDED|95.0|-1.94|1.85|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.85|-1.94|0.963
71919620|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.59||||0.625|TWO_SIDED|95.0|-1.77|2.94|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.94|-1.77|0.625
71919621|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08||||0.947|TWO_SIDED|95.0|-2.39|2.23|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.23|-2.39|0.947
71919622|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.505|TWO_SIDED|95.0|-1.25|2.53|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.53|-1.25|0.505
71919623|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.51||||0.564|TWO_SIDED|95.0|-1.23|2.25|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.25|-1.23|0.564
71919624|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.739|TWO_SIDED|95.0|-2.21|1.57|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.57|-2.21|0.739
71919625|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.766|TWO_SIDED|95.0|-2.27|1.67|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||1.67|-2.27|0.766
71919626|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.931|TWO_SIDED|95.0|-1.92|2.1|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||2.10|-1.92|0.931
71919627|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|0.19||||0.911|TWO_SIDED|95.0|-3.17|3.56|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.56|-3.17|0.911
71919628|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.003|TWO_SIDED|95.0|0.92|4.3|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.30|0.92|0.003
71919629|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|4.18|||<|0.001|TWO_SIDED|95.0|1.79|6.58|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.58|1.79|<0.001
71919630|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45||||0.005|TWO_SIDED|95.0|1.03|5.86|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.86|1.03|0.005
71919631|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.15||||0.004|TWO_SIDED|95.0|1.01|5.3|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.30|1.01|0.004
71919632|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61||||0.023|TWO_SIDED|95.0|0.36|4.87|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||4.87|0.36|0.023
71919633|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75||||0.008|TWO_SIDED|95.0|0.96|6.54|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.54|0.96|0.008
71919634|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.52||||0.012|TWO_SIDED|95.0|0.78|6.26|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.26|0.78|0.012
71919635|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.81|||<|0.001|TWO_SIDED|95.0|1.55|6.07|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||6.07|1.55|<0.001
71919636|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.75|||<|0.001|TWO_SIDED|95.0|1.68|5.83|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.83|1.68|<0.001
71919637|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.3||||0.004|TWO_SIDED|95.0|1.05|5.54|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||5.54|1.05|0.004
71919638|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.63||||0.175|TWO_SIDED|95.0|-0.73|3.99|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.99|-0.73|0.175
71919639|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|1.35||||0.27|TWO_SIDED|95.0|-1.05|3.75|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||3.75|-1.05|0.270
71919640|NCT00242710|143361087|SUPERIORITY_OR_OTHER||LS Mean Difference|3.78||||0.077|TWO_SIDED|95.0|-0.41|7.97|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.||7.97|-0.41|0.077
71919641|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.826|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.826
71919642|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.534|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.534
71919643|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||1.000
71919644|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.516|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.516
71919645|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.446
71919646|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.218|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.218
71919647|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||1.000
71919648|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
71919649|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.733
71919650|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.736|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.736
71919651|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.449|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.449
71919652|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.489|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.489
71919653|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.163|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.163
71919654|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.813|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.813
71919655|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.777|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.777
71919656|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.448
71919657|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.507|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.507
71919658|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.669|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.669
71919659|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.281|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.281
71919660|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.689
71919661|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.437|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||0.437
71919662|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||1.000
71919663|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||1.000
71919664|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.227|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.227
71919665|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.758|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.758
71919666|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.554|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.554
71919667|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||<0.001
71919668|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||<0.001
71919669|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||<0.001
71919670|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||<0.001
71919671|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||<0.001
71919672|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||<0.001
71919673|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.008
71919674|NCT00242710|143361088|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||<0.001
71919675|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.005
71919676|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.008
71919677|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.062
71919678|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.007
71919679|NCT00242710|143361088|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.029
71919680|NCT00242710|143361090|SUPERIORITY_OR_OTHER||LS Mean Difference|3.25|||<|0.001|TWO_SIDED|95.0|1.92|4.58|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.58|1.92|<0.001
71919681|NCT00242710|143361090|SUPERIORITY_OR_OTHER||LS Mean Difference|3.14|||<|0.001|TWO_SIDED|95.0|1.83|4.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||4.46|1.83|<0.001
71919682|NCT00242710|143361090|SUPERIORITY_OR_OTHER||LS Mean Difference|4.68|||<|0.001|TWO_SIDED|95.0|3.13|6.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||6.23|3.13|<0.001
71919683|NCT00242710|143361091|SUPERIORITY_OR_OTHER||LS Mean Difference|1.83|||<|0.001|TWO_SIDED|95.0|0.8|2.87|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.87|0.80|<0.001
71919684|NCT00242710|143361091|SUPERIORITY_OR_OTHER||LS Mean Difference|1.94|||<|0.001|TWO_SIDED|95.0|0.92|2.97|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||2.97|0.92|<0.001
71919685|NCT00242710|143361091|SUPERIORITY_OR_OTHER||LS Mean Difference|2.38|||<|0.001|TWO_SIDED|95.0|1.17|3.59|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.||3.59|1.17|<0.001
71919686|NCT03049852|143361135|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71919687|NCT03049852|143361137|SUPERIORITY||Mean Difference (Final Values)|0.27||||0.007|TWO_SIDED||||||ANOVA|||||||0.007
71919688|NCT00498706|143361144|SUPERIORITY_OR_OTHER||t value|-2.95||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71919689|NCT00498706|143361145|SUPERIORITY_OR_OTHER||Chi-square|5.83||||0.02||95.0|||||Chi-squared|||||||0.02
71919690|NCT00498706|143361145|SUPERIORITY_OR_OTHER||Chi-square|7.75||||0.006||95.0|||||Chi-squared||Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.|||||.006
71919691|NCT00498706|143361147|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|-0.09|STANDARD_DEVIATION|1.26||0.89|TWO_SIDED|95.0|-1.35|1.17|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||1.17|-1.35|0.89
71919692|NCT00498706|143361148|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|1.07|STANDARD_DEVIATION|1.695||0.22|TWO_SIDED|95.0|-0.63|2.76|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.||2.76|-0.63|0.22
71919693|NCT01928186|143361178|OTHER|||||||0.51|||||||Fisher Exact|the mid-P adjustment to Fisher's exact test||Association between response assessed by Ki-67 protein staining (i.e. \< 10% positive cells in the surgical sample) and by the influx constant Ki decline (i.e. 30 % or larger decline between the baseline and post-therapy FLT PET) was analyzed using the mid-P adjustment to Fisher's exact test.||||0.51
71919694|NCT04540627|143361192|SUPERIORITY|||||||0.5802|||||||Wilcoxon (Mann-Whitney)|||||||0.5802
71919695|NCT04540627|143361193|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
71919696|NCT04540627|143361194|SUPERIORITY|||||||0.2681|||||||Wilcoxon (Mann-Whitney)|||||||0.2681
71919697|NCT04540627|143361195|SUPERIORITY|||||||0.2431|||||||Wilcoxon (Mann-Whitney)|||||||0.2431
71919698|NCT04540627|143361200|SUPERIORITY|||||||0.4868|||||||Wilcoxon (Mann-Whitney)|||||||0.4868
71919699|NCT04540627|143361202|SUPERIORITY|||||||0.0403|||||||Wilcoxon (Mann-Whitney)|||||||0.0403
71919700|NCT01265719|143361220|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.33|STANDARD_ERROR_OF_MEAN|0.2||0.1126|TWO_SIDED|95.0|-0.09|0.74|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|\<5 years||0.74|-0.09|0.1126
71919701|NCT01265719|143361220|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.484|TWO_SIDED|95.0|-0.12|0.06|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|5 to \<18 years||0.06|-0.12|0.4840
71919702|NCT01265719|143361222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.3||0.902|TWO_SIDED|95.0|-0.63|0.56|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|\<5 years||0.56|-0.63|0.9020
71919703|NCT01265719|143361222|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.2||0.8826|TWO_SIDED|95.0|-0.37|0.43|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|5 to \<18 years||0.43|-0.37|0.8826
71919704|NCT01265719|143361223|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.62|STANDARD_ERROR_OF_MEAN|1.25||0.2003|TWO_SIDED|95.0|-4.13|0.89|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|\<5 years||0.89|-4.13|0.2003
71919705|NCT01265719|143361223|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.75||0.894|TWO_SIDED|95.0|-1.59|1.39|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP \<21mmHg at Baseline)||1.39|-1.59|0.8940
71919706|NCT01265719|143361223|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-6.66|STANDARD_ERROR_OF_MEAN|2.41||0.0184|TWO_SIDED|95.0|-11.95|-1.36|||ANCOVA|The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).|Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to \<18 years (IOP ≥21mmHg at Baseline)||-1.36|-11.95|0.0184
71919707|NCT01265719|143361224|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.0|||>|0.999|TWO_SIDED|95.0|-13.97|15.9|||Fisher Exact|||||15.90|-13.97|>0.999
71919708|NCT01265719|143361225|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|-0.4|||>|0.999|TWO_SIDED|95.0|-15.32|14.55|||Fisher Exact|||||14.55|-15.32|>0.999
71919709|NCT01265719|143361226|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.2|||>|0.999|TWO_SIDED|95.0|-13.78|16.09|||Fisher Exact|||||16.09|-13.78|>0.999
71919710|NCT01265719|143361228|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|1.6||||0.6414|TWO_SIDED|95.0|-13.39|16.48|||Fisher Exact|||||16.48|-13.39|0.6414
71919711|NCT01265719|143361229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|0.61|STANDARD_ERROR_OF_MEAN|0.52||0.2437|TWO_SIDED|95.0|-0.43|1.65|||ANCOVA||Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|\<5 years||1.65|-0.43|0.2437
71919712|NCT01265719|143361229|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.32||0.5199|TWO_SIDED|95.0|-0.85|0.43|||ANCOVA||Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|5 to \<18 years||0.43|-0.85|0.5199
71922414|NCT00303602|143365255|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.020
71922415|NCT00303602|143365256|SUPERIORITY_OR_OTHER|||||||0.834||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.||||||0.834
71922416|NCT00303602|143365257|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.||||||0.022
71922417|NCT00303602|143365258|SUPERIORITY_OR_OTHER|||||||0.515||95.0||||Endpoint Metabolic Syndrome p-value|Fisher Exact|||||||0.515
71919713|NCT01265719|143361230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-2.68|STANDARD_ERROR_OF_MEAN|15.54||0.8643|TWO_SIDED|95.0|-34.3|28.94|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|\<5 years||28.94|-34.30|0.8643
71919714|NCT01265719|143361230|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.87|STANDARD_ERROR_OF_MEAN|4.87||0.8591|TWO_SIDED|95.0|-10.54|8.8|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|5 to \<18 years||8.80|-10.54|0.8591
71919715|NCT01265719|143361231|SUPERIORITY_OR_OTHER_LEGACY||Difference in percentage|4.5||||0.2413|TWO_SIDED|95.0|-10.49|19.36|||Fisher Exact|||||19.36|-10.49|0.2413
71919716|NCT01797302|143361243|SUPERIORITY|||||||0.88||||||interaction term from model group\*time|Mixed Models Analysis|||||||0.88
71919717|NCT01797302|143361244|SUPERIORITY|||||||0.85||||||interaction term for group\*time|Mixed Models Analysis|||||||0.85
71919718|NCT01797302|143361245|SUPERIORITY|||||||0.61||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.61
71919719|NCT01797302|143361246|SUPERIORITY|||||||0.24||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.24
71919720|NCT01797302|143361247|SUPERIORITY|||||||0.0117||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0117
71919721|NCT01797302|143361248|SUPERIORITY|||||||0.53||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.53
71919722|NCT01797302|143361249|SUPERIORITY|||||||0.0256||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0256
71919723|NCT01797302|143361250|SUPERIORITY|||||||0.0945||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0945
71919724|NCT01797302|143361251|SUPERIORITY|||||||0.12||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.12
71919725|NCT01797302|143361252|SUPERIORITY|||||||0.0094||||||interaction term group\*time from linear mixed model|Mixed Models Analysis|||||||0.0094
71919726|NCT00848172|143361322|SUPERIORITY_OR_OTHER||||||=|0.345||95.0|||||Mixed Models Analysis|||||||=0.345
71919727|NCT00848172|143361323|SUPERIORITY_OR_OTHER||||||=|0.031||95.0|||||Mixed Models Analysis|||||||=0.031
71919728|NCT00721136|143361327|OTHER|||||||||||||||||Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|||
71919729|NCT01051856|143361392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Chi-squared|||||||0.35
71919730|NCT02176226|143361395|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71919731|NCT02176226|143361396|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71919732|NCT03894501|143361418|SUPERIORITY|||||||0.048|||||||ANOVA|||||||.048
71919733|NCT03894501|143361419|SUPERIORITY|||||||0.037|||||||ANCOVA|||||||.037
71919734|NCT03894501|143361420|SUPERIORITY|||||||0.024|||||||ANCOVA|||||||.024
71919735|NCT03894501|143361421|SUPERIORITY|||||||0.005|||||||ANCOVA|||||||.005
71919736|NCT03894501|143361422|SUPERIORITY|||||||0.013|||||||ANOVA|||||||.013
71919737|NCT03894501|143361423|SUPERIORITY|||||||0.035|||||||ANOVA|||||||.035
71919738|NCT01412333|143361432|SUPERIORITY_OR_OTHER_LEGACY||Rate Ratio|0.532|||<|0.0001|TWO_SIDED|95.0|0.397|0.714|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||0.714|0.397|< 0.0001
71919739|NCT01412333|143361433|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.0169|TWO_SIDED|95.0|0.42|0.92|||Log Rank|||Time to onset of CDP at week 12||0.92|0.42|= 0.0169
71919740|NCT01412333|143361434|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.051|||<|0.0001||95.0|0.029|0.089|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.089|0.029|< 0.0001
71919741|NCT01412333|143361435|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.171|||<|0.0001||95.0|0.13|0.225|||Negative Binomial Model||Adjusted by baseline T2 lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.225|0.130|< 0.0001
71919742|NCT01412333|143361436|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.14|||=|0.4019|TWO_SIDED|95.0|0.84|1.56|||CMH Chi-Squared test (stratified)|Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (\<4.0 vs. \>=4.0).||||1.56|0.84|= 0.4019
71919743|NCT01412333|143361437|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63|||=|0.037|TWO_SIDED|95.0|0.4|0.98|||Log Rank|||Time to onset of CDP at week 24||0.98|0.40|= 0.037
71919744|NCT01412333|143361438|SUPERIORITY_OR_OTHER_LEGACY||Adjusted rate ratio|0.357|||<|0.0001||95.0|0.272|0.47|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\<4.0 vs. \>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.|||0.47|0.272|< 0.0001
71919745|NCT01412333|143361439|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.107|STANDARD_ERROR_OF_MEAN|0.037|=|0.004|TWO_SIDED|95.0|0.034|0.18|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.180|0.034|= 0.004
71919746|NCT01412333|143361440|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|0.112|STANDARD_ERROR_OF_MEAN|0.066|=|0.09|TWO_SIDED|95.0|-0.018|0.241|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||0.241|-0.018|= 0.09
71919747|NCT01412333|143361441|SUPERIORITY_OR_OTHER_LEGACY||Difference in Adjusted Means|1.159|STANDARD_ERROR_OF_MEAN|0.564|=|0.0404|TWO_SIDED|95.0|0.051|2.268|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.|||2.268|0.051|= 0.0404
71922418|NCT00303602|143365259|SUPERIORITY_OR_OTHER|||||||0.118||95.0|||||Mixed Models Analysis|||||||0.118
71922419|NCT00303602|143365260|SUPERIORITY_OR_OTHER|||||||0.161||95.0|||||Mixed Models Analysis|||||||0.161
71922420|NCT00303602|143365261|SUPERIORITY_OR_OTHER|||||||0.229||95.0|||||Mixed Models Analysis|||||||0.229
71919748|NCT01412333|143361442|SUPERIORITY_OR_OTHER_LEGACY||Relative risk (stratified)|1.81|||<|0.0001|TWO_SIDED|95.0|1.41|2.32|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\<4.0 vs. \>=4.0).||||2.32|1.41|< 0.0001
71919749|NCT00256204|143361463|SUPERIORITY_OR_OTHER|||||||0.0133|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 1mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start) and 2mg (delayed-start)are combined to one placebo group."||||0.0133
71919750|NCT00256204|143361463|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 2mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start)and 2mg (delayed-start) are combined to one placebo group."||||0.0001
71919751|NCT00256204|143361463|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center .|Repeated Measures|||Hypothesis #2: Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set).||||0.0250
71919752|NCT00256204|143361463|SUPERIORITY_OR_OTHER|||||||0.6028||95.0||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center|Repeated Measures|||Hypothesis #2:Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set.)||||0.6028
71919753|NCT00256204|143361463|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 1mg early-start group and the 1mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.0||||||90.0|-0.036|0.036||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.036|-0.036|
71919754|NCT00256204|143361463|NON_INFERIORITY_OR_EQUIVALENCE|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 2mg early-start group and the 2mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.029||||||90.0|-0.005|0.062||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."||0.062|-0.005|
71919755|NCT00256204|143361464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.005|||<|0.0001||95.0|-3.857|-2.153|||ANCOVA|||The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates. For this analysis, both delayed start arms are pooled as a 'placebo arm'||-2.153|-3.857|<0.0001
71919756|NCT00256204|143361464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.154|||<|0.0001||95.0|-4.004|-2.305|||ANCOVA|||"The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates.~For this analysis, both delayed start arms are pooled as a 'placebo arm'"||-2.305|-4.004|<0.0001
71919757|NCT03427528|143361467|OTHER|To assess paternal and maternal outcomes on the BDI-II we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our BDI-II.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
71919758|NCT03427528|143361468|OTHER|To assess paternal and maternal outcomes on the GAD-7, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our outcomes.|||||>|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
71922421|NCT03993314|143365263|SUPERIORITY|||||||0.757||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients achieving a level of numbness of T6 or higher between the two groups.||||0.757
71922422|NCT03993314|143365264|SUPERIORITY|||||||0.186||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median level of numbness between the two groups.||||0.186
71882756|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3274|STANDARD_ERROR_OF_MEAN|3.2552||0.0283|TWO_SIDED|80.0|-11.55|-3.106|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-3.106|-11.55|0.0283
71882757|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1505|STANDARD_ERROR_OF_MEAN|1.5974||0.1852|TWO_SIDED|80.0|-4.229|-0.0719|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0719|-4.229|0.1852
71882758|NCT00531752|143284707|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5178|STANDARD_ERROR_OF_MEAN|1.7732||0.1623|TWO_SIDED|80.0|-4.823|-0.2127|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2127|-4.823|0.1623
71882759|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.5791|STANDARD_ERROR_OF_MEAN|18.0449||0.5241|TWO_SIDED|80.0|-35.02|11.86|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||11.860|-35.02|0.5241
71882760|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|-20.3367|STANDARD_ERROR_OF_MEAN|19.6995||0.3065|TWO_SIDED|80.0|-45.89|5.2183|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.2183|-45.89|0.3065
71882761|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.7878|STANDARD_ERROR_OF_MEAN|13.4438||0.3831|TWO_SIDED|80.0|-29.15|5.5793|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5793|-29.15|0.3831
71882762|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.1401|STANDARD_ERROR_OF_MEAN|14.4478||0.3657|TWO_SIDED|80.0|-31.8|5.5241|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5241|-31.80|0.3657
71882763|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|2.666|STANDARD_ERROR_OF_MEAN|11.5818||0.8188|TWO_SIDED|80.0|-12.36|17.69|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||17.690|-12.36|0.8188
71882764|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|24.1011|STANDARD_ERROR_OF_MEAN|12.405||0.0566|TWO_SIDED|80.0|8.0305|40.172|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||40.172|8.0305|0.0566
71882765|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7559|STANDARD_ERROR_OF_MEAN|8.7164||0.9312|TWO_SIDED|80.0|-10.55|12.057|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.057|-10.55|0.9312
71882766|NCT00531752|143284708|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1138|STANDARD_ERROR_OF_MEAN|9.4361||0.5194|TWO_SIDED|80.0|-6.108|18.336|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||18.336|-6.108|0.5194
71882767|NCT00531752|143284709|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3255|STANDARD_ERROR_OF_MEAN|0.332||0.332|TWO_SIDED|80.0|-0.7573|0.10622|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.10622|-0.7573|0.3320
71882768|NCT00531752|143284709|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4255|STANDARD_ERROR_OF_MEAN|0.3871||0.2767|TWO_SIDED|80.0|-0.0769|0.92804|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.92804|-0.0769|0.2767
71882769|NCT00531752|143284709|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3661|STANDARD_ERROR_OF_MEAN|0.4028||0.3675|TWO_SIDED|80.0|-0.8887|0.1566|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.15660|-0.8887|0.3675
71882770|NCT00531752|143284709|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1033|STANDARD_ERROR_OF_MEAN|0.4372||0.8141|TWO_SIDED|80.0|-0.67|0.46345|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.46345|-0.6700|0.8141
71882771|NCT00531752|143284709|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1854|STANDARD_ERROR_OF_MEAN|0.3702||0.6186|TWO_SIDED|80.0|-0.6657|0.29495|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.29495|-0.6657|0.6186
71882772|NCT00531752|143284709|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3623|STANDARD_ERROR_OF_MEAN|0.4028||0.372|TWO_SIDED|80.0|-0.1597|0.88432|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.88432|-0.1597|0.3720
71882773|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|25.0781|STANDARD_ERROR_OF_MEAN|5.0238|<|0.0001|TWO_SIDED|80.0|18.565|31.591|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.591|18.565|<0.0001
71882774|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|15.6481|STANDARD_ERROR_OF_MEAN|5.3551||0.0049|TWO_SIDED|80.0|8.711|22.585|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||22.585|8.7110|0.0049
71919759|NCT03427528|143361469|OTHER|To assess paternal and maternal outcomes on the PSS-10, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
71919760|NCT03427528|143361469|OTHER|To assess paternal and maternal outcomes on the PSS-10 we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.|||||<|0.05|||||||Paired T-test|||We used a single group longitudinal pre-post design to evaluate study outcomes||||<0.05
71919761|NCT03427528|143361470|OTHER||||||>|0.05|||||||t-test, 2 sided|||We used a single group longitudinal pre-post design to evaluate study outcomes||||>0.05
71919762|NCT00808132|143361474|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|1.51|||<|0.001|TWO_SIDED|95.0|0.822|2.201|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.201|0.822|<0.001
71919763|NCT00808132|143361474|SUPERIORITY_OR_OTHER||LS Mean Difference|1.87|||<|0.001|TWO_SIDED|95.0|1.209|2.533|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.533|1.209|<0.001
71919764|NCT00808132|143361475|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.017|TWO_SIDED|95.0|0.139|1.47|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.470|0.139|0.017
71919765|NCT00808132|143361475|SUPERIORITY_OR_OTHER||LS Mean Difference|1.19|||<|0.001|TWO_SIDED|95.0|0.556|1.83|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.830|0.556|<0.001
71919766|NCT00808132|143361476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.32|||<|0.001|TWO_SIDED|95.0|0.901|1.742|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.742|0.901|<0.001
71919767|NCT00808132|143361476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|||<|0.001|TWO_SIDED|95.0|0.756|1.671|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.671|0.756|<0.001
71919768|NCT00808132|143361476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.56|||<|0.001|TWO_SIDED|95.0|1.152|1.962|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||1.962|1.152|<0.001
71919769|NCT00808132|143361476|SUPERIORITY_OR_OTHER||LS Mean Difference|1.6|||<|0.001|TWO_SIDED|95.0|1.164|2.044|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.||2.044|1.164|<0.001
71919770|NCT00808132|143361477|SUPERIORITY_OR_OTHER|||||||0.138|TWO_SIDED||||||Fisher Exact|||||||0.138
71919771|NCT00808132|143361477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71919772|NCT00808132|143361477|SUPERIORITY_OR_OTHER|||||||0.765|TWO_SIDED||||||Fisher Exact|||||||0.765
71919773|NCT00808132|143361477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71919774|NCT00808132|143361477|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||< 0.001
71919775|NCT00808132|143361478|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.06||||0.832|TWO_SIDED|95.0|-0.632|0.509|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.509|-0.632|0.832
71919776|NCT00808132|143361478|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.651|TWO_SIDED|95.0|-0.696|0.436|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.436|-0.696|0.651
71919777|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919778|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0074|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0074
71919779|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919780|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919781|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919782|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919783|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919784|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919785|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919786|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
71919787|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71686397|NCT03077607|142890419|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|105.37|||||TWO_SIDED|90.0|98.04|113.24||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||113.24|98.04|
71686398|NCT03077607|142890420|EQUIVALENCE|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|102.04|||||TWO_SIDED|90.0|94.02|110.74||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.||110.74|94.02|
71879505|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3326|TWO_SIDED|95.0|-0.012|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.012|0.3326
71879506|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.029|STANDARD_ERROR_OF_MEAN|0.012||0.0151|TWO_SIDED|95.0|0.006|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.006|0.0151
71879507|NCT01431274|143278884|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1421|TWO_SIDED|95.0|-0.041|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.006|-0.041|0.1421
71879508|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.693|STANDARD_ERROR_OF_MEAN|0.553||0.0022|TWO_SIDED|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.608|-2.778|0.0022
71879509|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.233|STANDARD_ERROR_OF_MEAN|0.551||0.0252|TWO_SIDED|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.153|-2.313|0.0252
71879510|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.031|STANDARD_ERROR_OF_MEAN|0.552||0.062|TWO_SIDED|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.052|-2.113|0.0620
71879511|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.456|STANDARD_ERROR_OF_MEAN|0.548||0.4051|TWO_SIDED|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.618|-1.531|0.4051
71879512|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.571|STANDARD_ERROR_OF_MEAN|0.55||0.2988|TWO_SIDED|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.507|-1.649|0.2988
71879513|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.662|STANDARD_ERROR_OF_MEAN|0.545||0.2249|TWO_SIDED|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.407|-1.731|0.2249
71882775|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.627|STANDARD_ERROR_OF_MEAN|3.5248||0.3078|TWO_SIDED|80.0|-8.196|0.94237|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.94237|-8.196|0.3078
71882776|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|7.1594|STANDARD_ERROR_OF_MEAN|3.8022||0.0644|TWO_SIDED|80.0|2.2344|12.084|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.084|2.2344|0.0644
71919788|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919789|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71879514|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.118|STANDARD_ERROR_OF_MEAN|0.549||0.0418|TWO_SIDED|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.042|-2.195|0.0418
71879515|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.557||0.4097|TWO_SIDED|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.633|-1.552|0.4097
71879516|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.575|STANDARD_ERROR_OF_MEAN|0.556||0.3013|TWO_SIDED|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.515|-1.664|0.3013
71879517|NCT01431274|143278885|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.554||0.8355|TWO_SIDED|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||1.200|-0.970|0.8355
71879518|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.42|STANDARD_ERROR_OF_MEAN|0.135||0.0019|TWO_SIDED|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.684|0.155|0.0019
71879519|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.356|STANDARD_ERROR_OF_MEAN|0.135||0.0082|TWO_SIDED|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.619|0.092|0.0082
71879520|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.416|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.681|0.152|0.0020
71879521|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.29|STANDARD_ERROR_OF_MEAN|0.134||0.0307|TWO_SIDED|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.554|0.027|0.0307
71879522|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.352|STANDARD_ERROR_OF_MEAN|0.135||0.0088|TWO_SIDED|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.616|0.089|0.0088
71879523|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.134||0.9801|TWO_SIDED|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.266|-0.259|0.9801
71919790|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.1058|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.1058
71919791|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919792|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0024|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0024
71919793|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919794|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919795|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919796|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919797|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919798|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0012
71919799|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919800|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919801|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919802|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0029
71919803|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919804|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0046
71919805|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919806|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0043|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0043
71919807|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919808|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919809|NCT00808132|143361479|SUPERIORITY_OR_OTHER|||||||0.0016|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||0.0016
71919810|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919811|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919812|NCT00808132|143361479|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.||||<0.001
71919813|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.546|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.546
71919814|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.821|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.821
71919815|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.698|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.698
71919816|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.446|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.446
71919817|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
71919818|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.810
71919819|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.473|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.473
71919820|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.030
71919821|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.453|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.453
71919822|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.391
71919823|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.407|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.407
71919824|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.644|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.644
71919825|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.666|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.666
71919826|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.641|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.641
71919827|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.361|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.361
71919828|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.100
71919829|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.142
71919830|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.906
71919831|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.798
71919832|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.258|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.258
71919833|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.058|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.058
71919834|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.230
71919835|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.360
71919836|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.892
71919837|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.912|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.912
71919838|NCT00808132|143361481|SUPERIORITY_OR_OTHER|||||||0.791|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.||||0.791
71919839|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93||||0.253|TWO_SIDED|95.0|-7.96|2.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.10|-7.96|0.253
71919840|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84||||0.127|TWO_SIDED|95.0|-8.78|1.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.10|-8.78|0.127
71919841|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.15||||0.18|TWO_SIDED|95.0|-7.76|1.46|||ANCOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.46|-7.76|0.180
71919842|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.67||||0.247|TWO_SIDED|95.0|-7.19|1.85|||ANOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.85|-7.19|0.247
71919843|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.63||||0.726|TWO_SIDED|95.0|-4.15|2.9|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.90|-4.15|0.726
71919844|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.17||||0.218|TWO_SIDED|95.0|-5.63|1.29|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.29|-5.63|0.218
71919845|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|0.01||||0.996|TWO_SIDED|95.0|-3.85|3.87|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||3.87|-3.85|0.996
71919846|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean DIfference|0.83||||0.665|TWO_SIDED|95.0|-2.94|4.6|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||4.60|-2.94|0.665
71919847|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|2.76||||0.368|TWO_SIDED|95.0|-3.26|8.78|||ANOVA|||Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.78|-3.26|0.368
71919848|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|2.84||||0.345|TWO_SIDED|95.0|-3.07|8.75|||ANCOVA|||Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||8.75|-3.07|0.345
71919849|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.35||||0.482|TWO_SIDED|95.0|-5.12|2.42|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||2.42|-5.12|0.482
71919850|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean DIfference|-2.15||||0.254|TWO_SIDED|95.0|-5.86|1.55|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.55|-5.86|0.254
71919851|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.97||||0.308|TWO_SIDED|95.0|-5.76|1.82|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.82|-5.76|0.308
71919852|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48||||0.19|TWO_SIDED|95.0|-6.2|1.23|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||1.23|-6.20|0.190
71919853|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.07||||0.55|TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.17|-0.32|0.550
71919854|NCT00808132|143361482|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.477|TWO_SIDED|95.0|-0.15|0.32|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||0.32|-0.15|0.477
71919855|NCT00808132|143361484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
71919856|NCT00808132|143361484|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||<0.001
71919857|NCT00808132|143361484|SUPERIORITY_OR_OTHER|||||||0.68|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.680
71919858|NCT00808132|143361484|SUPERIORITY_OR_OTHER|||||||0.493|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.493
71919859|NCT00808132|143361484|SUPERIORITY_OR_OTHER|||||||0.698|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.698
71919860|NCT00808132|143361484|SUPERIORITY_OR_OTHER|||||||0.055|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.055
71919861|NCT00808132|143361484|SUPERIORITY_OR_OTHER|||||||0.428|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.428
71879524|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.294|STANDARD_ERROR_OF_MEAN|0.134||0.0289|TWO_SIDED|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.557|0.030|0.0289
71879525|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.136||0.6382|TWO_SIDED|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.330|-0.202|0.6382
71879526|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.135||0.3525|TWO_SIDED|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.391|-0.140|0.3525
71879527|NCT01431274|143278886|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.062|STANDARD_ERROR_OF_MEAN|0.135||0.6457|TWO_SIDED|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.203|-0.327|0.6457
71879528|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0067|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0067
71879529|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.081|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
71879530|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.012||0.0746|TWO_SIDED|95.0|-0.002|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.002|0.0746
71879531|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.078|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.054|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.101|0.054|<0.0001
71879532|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.046|<0.0001
71879533|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.012||0.3549|TWO_SIDED|95.0|-0.013|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.035|-0.013|0.3549
71879534|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.089|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.065|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.113|0.065|<0.0001
71919862|NCT00808132|143361484|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.||||0.071
71919863|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.624
71919864|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.868|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.868
71919865|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.087|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.087
71919866|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.425|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.425
71919867|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.307|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.307
71919868|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.689|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.689
71882777|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|4.5601|STANDARD_ERROR_OF_MEAN|3.1318||0.1517|TWO_SIDED|80.0|0.49198|8.6281|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.6281|0.49198|0.1517
71882778|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7384|STANDARD_ERROR_OF_MEAN|3.3281||0.8252|TWO_SIDED|80.0|-5.056|3.5789|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.5789|-5.056|0.8252
71882779|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6228|STANDARD_ERROR_OF_MEAN|0.2203||0.0063|TWO_SIDED|80.0|-0.9082|-0.3375|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3375|-0.9082|0.0063
71882780|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2301|STANDARD_ERROR_OF_MEAN|0.2303||0.3217|TWO_SIDED|80.0|-0.5283|0.06822|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.06822|-0.5283|0.3217
71882781|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1291|STANDARD_ERROR_OF_MEAN|0.1065||0.2307|TWO_SIDED|80.0|-0.0091|0.26716|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.26716|-0.0091|0.2307
71882782|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
71882783|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.6629|STANDARD_ERROR_OF_MEAN|3.8642||0.3477|TWO_SIDED|80.0|-8.681|1.3549|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.3549|-8.681|0.3477
71882784|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8688|STANDARD_ERROR_OF_MEAN|4.0842||0.1565|TWO_SIDED|80.0|-11.17|-0.5693|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5693|-11.17|0.1565
71882785|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4319|STANDARD_ERROR_OF_MEAN|3.9541||0.1088|TWO_SIDED|80.0|-11.55|-1.311|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.311|-11.55|0.1088
71882786|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|4.1517||0.8627|TWO_SIDED|80.0|-4.654|6.0952|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.0952|-4.654|0.8627
71882787|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|56.631|STANDARD_ERROR_OF_MEAN|17.8056||0.0024|TWO_SIDED|80.0|33.532|79.73|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||79.730|33.532|0.0024
71882788|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|49.1543|STANDARD_ERROR_OF_MEAN|18.7622||0.0112|TWO_SIDED|80.0|24.831|73.478|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||73.478|24.831|0.0112
71882789|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|10.9197|STANDARD_ERROR_OF_MEAN|3.0912||0.0008|TWO_SIDED|80.0|6.9105|14.929|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.929|6.9105|0.0008
71882790|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|8.4691|STANDARD_ERROR_OF_MEAN|3.3037||0.0129|TWO_SIDED|80.0|4.1876|12.751|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.751|4.1876|0.0129
71882791|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|14.1078|STANDARD_ERROR_OF_MEAN|4.3667||0.002|TWO_SIDED|80.0|8.4492|19.766|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||19.766|8.4492|0.0020
71882792|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|14.3485|STANDARD_ERROR_OF_MEAN|4.5692||0.0026|TWO_SIDED|80.0|8.4275|20.27|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||20.270|8.4275|0.0026
71882793|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2989|STANDARD_ERROR_OF_MEAN|3.4103||0.9305|TWO_SIDED|80.0|-4.729|4.1309|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.1309|-4.729|0.9305
71882794|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.7062|STANDARD_ERROR_OF_MEAN|3.5839||0.1178|TWO_SIDED|80.0|-10.36|-1.05|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.050|-10.36|0.1178
71882795|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4586|STANDARD_ERROR_OF_MEAN|2.5231||0.3339|TWO_SIDED|80.0|-0.8124|5.7295|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.7295|-0.8124|0.3339
71686399|NCT06010732|142890466|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.986|TWO_SIDED|95.0|-5.5|5.4||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||5.4|-5.5|0.986
71879535|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.072|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.072|<0.0001
71879536|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|-0.08|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-0.080|<0.0001
71879537|NCT01431274|143278887|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.012||0.5018|TWO_SIDED|95.0|-0.016|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.016|0.5018
71879538|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.104|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.104|<0.0001
71879539|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.102|0.15||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.150|0.102|<0.0001
71879540|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.087|0.135||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.135|0.087|<0.0001
71879541|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.096|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.072|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.072|<0.0001
71879542|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.109|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.085|0.133||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.133|0.085|<0.0001
71879543|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1569|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1569
71879544|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.113|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.089|0.137||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.137|0.089|<0.0001
71882796|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.63||0.0698|TWO_SIDED|80.0|1.4493|8.2686|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||8.2686|1.4493|0.0698
71686400|NCT06010732|142890466|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.6|21.7|<0.001
71686401|NCT06010732|142890466|SUPERIORITY||Mean Difference (Final Values)|27.2|||<|0.001|TWO_SIDED|95.0|21.7|32.7||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|Based on previous studies we estimate the standard deviation of the differences between treatments in the crossover model to be 20 for % SMH recovery. With a sample size of 58 subjects completing the study, the study had 80% power to detect a difference between any two treatments of 7.5 for % SMH recovery, assuming two-sided tests each conducted at a 5% significance level.||32.7|21.7|<0.001
71686402|NCT06010732|142890467|SUPERIORITY||Ratio of Means|1.11||||0.23|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(EFU)||1.32|0.93|0.230
71686403|NCT06010732|142890467|SUPERIORITY||Ratio of Means|5.77|||<|0.001|TWO_SIDED|95.0|4.86|6.85||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(EFU)||6.85|4.86|<0.001
71686404|NCT06010732|142890467|SUPERIORITY||Ratio of Means|5.2|||<|0.001|TWO_SIDED|95.0|4.37|6.18||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(EFU)||6.18|4.37|<0.001
71686405|NCT06010732|142890468|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.272|TWO_SIDED|95.0|-2.5|8.6||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||8.6|-2.5|0.272
71686406|NCT06010732|142890468|SUPERIORITY||Mean Difference (Final Values)|34.8|||<|0.001|TWO_SIDED|95.0|29.3|40.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||40.3|29.3|<0.001
71686407|NCT06010732|142890468|SUPERIORITY||Mean Difference (Final Values)|31.7|||<|0.001|TWO_SIDED|95.0|26.2|37.3||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||37.3|26.2|<0.001
71686408|NCT06010732|142890469|SUPERIORITY||Ratio of Means|1.11||||0.191|TWO_SIDED|95.0|0.93|1.32||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(%CAR+100)||1.32|0.93|0.191
71686409|NCT06010732|142890469|SUPERIORITY||Ratio of Means|0.94||||0.003|TWO_SIDED|95.0|0.91|0.98||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(%CAR+100)||0.98|0.91|0.003
71686410|NCT06010732|142890469|SUPERIORITY||Ratio of Means|0.97||||0.092|TWO_SIDED|95.0|0.93|1.01||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(%CAR+100)||1.01|0.93|0.092
71686411|NCT06010732|142890470|SUPERIORITY||Ratio of Means|1.01||||0.905|TWO_SIDED|95.0|0.9|1.13||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(∆Z)||1.13|0.90|0.905
71879545|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.002|STANDARD_ERROR_OF_MEAN|0.012||0.8834|TWO_SIDED|95.0|-0.022|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.026|-0.022|0.8834
71919869|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.285
71686412|NCT06010732|142890470|SUPERIORITY||Ratio of Means|0.71|||<|0.001|TWO_SIDED|95.0|0.63|0.8||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(∆Z)||0.80|0.63|<0.001
71686413|NCT06010732|142890470|SUPERIORITY||Ratio of Means|0.7|||<|0.001|TWO_SIDED|95.0|0.63|0.79||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(∆Z)||0.79|0.63|<0.001
71879546|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.012||0.2129|TWO_SIDED|95.0|-0.009|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.009|0.2129
71879547|NCT01431274|143278888|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.013|STANDARD_ERROR_OF_MEAN|0.012||0.2702|TWO_SIDED|95.0|-0.037|0.01||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.010|-0.037|0.2702
71879548|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.117|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.166|0.117|<0.0001
71879549|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.115|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.09|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.139|0.090|<0.0001
71879550|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.119|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.094|0.143||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.143|0.094|<0.0001
71879551|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.099|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.074|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.074|<0.0001
71879552|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.092|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.067|0.117||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.117|0.067|<0.0001
71879553|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.023|STANDARD_ERROR_OF_MEAN|0.013||0.0717|TWO_SIDED|95.0|-0.002|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.002|0.0717
71879554|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.097|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.097|<0.0001
71879555|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.013||0.0344|TWO_SIDED|95.0|0.002|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.051|0.002|0.0344
71879556|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.013||0.1126|TWO_SIDED|95.0|-0.005|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.045|-0.005|0.1126
71879557|NCT01431274|143278889|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.013||0.6009|TWO_SIDED|95.0|-0.018|0.031||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.031|-0.018|0.6009
71879558|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.072|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.049|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.096|0.049|<0.0001
71919870|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
71879559|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.087|0.039|<0.0001
71879560|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0001|TWO_SIDED|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.070|0.023|0.0001
71879561|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.012||0.0122|TWO_SIDED|95.0|0.007|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.054|0.007|0.0122
71879562|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.012||0.0021|TWO_SIDED|95.0|0.014|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.061|0.014|0.0021
71879563|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.012||0.0347|TWO_SIDED|95.0|0.002|0.049||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.049|0.002|0.0347
71879564|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.032|0.08||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.080|0.032|<0.0001
71879565|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4407|TWO_SIDED|95.0|-0.014|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.033|-0.014|0.4407
71879566|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.016|STANDARD_ERROR_OF_MEAN|0.012||0.1777|TWO_SIDED|95.0|-0.007|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.040|-0.007|0.1777
71879567|NCT01431274|143278890|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5641|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5641
71879568|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.104|0.057|<0.0001
71879569|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.051|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.099|0.051|<0.0001
71879570|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.038|STANDARD_ERROR_OF_MEAN|0.012||0.0018|TWO_SIDED|95.0|0.014|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.062|0.014|0.0018
71879571|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0517|TWO_SIDED|95.0|0.0|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.000|0.0517
71919871|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.065
71919872|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.014
71919873|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||1.000
71686414|NCT06010732|142890471|SUPERIORITY||Ratio of Means|0.98||||0.721|TWO_SIDED|95.0|0.88|1.09||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Positive Control|analyzed as log(lesion depth)||1.09|0.88|0.721
71686415|NCT06010732|142890471|SUPERIORITY||Ratio of Means|0.75|||<|0.001|TWO_SIDED|95.0|0.68|0.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Test/Placebo|analyzed as log(lesion depth)||0.84|0.68|<0.001
71686416|NCT06010732|142890471|SUPERIORITY||Ratio of Means|0.77|||<|0.001|TWO_SIDED|95.0|0.69|0.86||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Ratio calculated as Positive Control/Placebo|analyzed as log(lesion depth)||0.86|0.69|<0.001
71686417|NCT06010732|142890472|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.647|TWO_SIDED|95.0|-2.95|1.84||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Positive Control|||1.84|-2.95|0.647
71686418|NCT06010732|142890472|SUPERIORITY||Mean Difference (Final Values)|6.35|||<|0.001|TWO_SIDED|95.0|3.95|8.75||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Test-Placebo|||8.75|3.95|<0.001
71686419|NCT06010732|142890472|SUPERIORITY||Mean Difference (Final Values)|6.9|||<|0.001|TWO_SIDED|95.0|4.49|9.31||No alpha-level adjustments for multiple comparisons adjustments were applied.|Mixed Models Analysis|Analysis of variance models (ANOVA) suitable for a crossover study, with random effect for subject and fixed effects for study period and product.|Difference calculated as Positive Control-Placebo|||9.31|4.49|<0.001
71879572|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.012||0.0072|TWO_SIDED|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|0.009|0.0072
71879573|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.012||0.0005|TWO_SIDED|95.0|0.019|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.066|0.019|0.0005
71686420|NCT04401202|142890473|SUPERIORITY|||||||0.001|||||||Chi-squared|||||||0.001
71686421|NCT03004924|142890532|SUPERIORITY||Difference in response rate|7.7||||0.127|TWO_SIDED|95.0|-1.6|16.9|||Fisher Exact|||||16.9|-1.6|0.127
71686422|NCT03004924|142890533|SUPERIORITY||Difference in response rate|-3.5||||0.5|TWO_SIDED|95.0|-12.8|5.9|||Fisher Exact|||||5.9|-12.8|0.500
71686423|NCT01119846|142890554|SUPERIORITY_OR_OTHER||Slope|0.5782|||||TWO_SIDED|90.0|0.523|0.6335|||||Dose Proportionality for GSK1292263 Using the Power Model.|||0.6335|0.5230|
71686424|NCT01119846|142890556|SUPERIORITY_OR_OTHER||Slope|0.5828|||||TWO_SIDED|90.0|0.5282|0.6375|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-24.|||0.6375|0.5282|
71686425|NCT01119846|142890556|SUPERIORITY_OR_OTHER||Slope|0.5808|||||TWO_SIDED|90.0|0.5325|0.6291|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-last.|||0.6291|0.5325|
71686426|NCT01119846|142890571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.036|||||TWO_SIDED|95.0|-1.17|1.1||||||||1.10|-1.17|
71686427|NCT01119846|142890571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.225|||||TWO_SIDED|95.0|-0.9|1.35||||||||1.35|-0.90|
71919874|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.226|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||0.226
71919875|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||1.000
71686428|NCT01119846|142890571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.046|||||TWO_SIDED|95.0|-1.1|1.19||||||||1.19|-1.10|
71686429|NCT01119846|142890571|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.679|||||TWO_SIDED|95.0|-1.8|0.45||||||||0.45|-1.80|
71686430|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|||||TWO_SIDED|95.0|-1.8|2.33|||||Comparison of AUC(0-24)|||2.33|-1.80|
71686431|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.614|||||TWO_SIDED|95.0|-1.53|2.76|||||Comparison of AUC(0-24)|||2.76|-1.53|
71919876|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919877|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
71879574|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.042|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|0.042|<0.0001
71882797|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3364|STANDARD_ERROR_OF_MEAN|0.1859||0.0762|TWO_SIDED|80.0|-0.5777|-0.095|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0950|-0.5777|0.0762
71686432|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.451|||||TWO_SIDED|95.0|-1.64|2.54|||||Comparison of AUC(0-24)|||2.54|-1.64|
71686433|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.469|||||TWO_SIDED|95.0|-1.39|2.33|||||Comparison of AUC(0-24)|||2.33|-1.39|
71686434|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29|||||TWO_SIDED|95.0|-2.53|1.95|||||Comparison of AUC(0-13)|||1.95|-2.53|
71879575|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.012||0.6619|TWO_SIDED|95.0|-0.018|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.029|-0.018|0.6619
71879576|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2401|TWO_SIDED|95.0|-0.01|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.038|-0.010|0.2401
71879577|NCT01431274|143278891|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.012||0.4601|TWO_SIDED|95.0|-0.033|0.015||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.015|-0.033|0.4601
71879578|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.088|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.064|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.112|0.064|<0.0001
71879579|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.052|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.052|<0.0001
71879580|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.07|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.046|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.094|0.046|<0.0001
71879581|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.027|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|0.027|<0.0001
71879582|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.034|0.082||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.082|0.034|<0.0001
71879583|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.1405|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1405
71879584|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.045|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.093|0.045|<0.0001
71879585|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.012||0.3118|TWO_SIDED|95.0|-0.012|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.036|-0.012|0.3118
71882798|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1591|STANDARD_ERROR_OF_MEAN|0.1913||0.4096|TWO_SIDED|80.0|-0.4075|0.08935|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.08935|-0.4075|0.4096
71919878|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
71882799|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2115|STANDARD_ERROR_OF_MEAN|0.1033||0.0455|TWO_SIDED|80.0|0.07751|0.3455|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.34550|0.07751|0.0455
71882800|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.08114|STANDARD_ERROR_OF_MEAN|0.1087||0.4585|TWO_SIDED|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.22209|-0.0598|0.4585
71919879|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919880|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919881|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919882|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919883|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919884|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919885|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919886|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919887|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919888|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919889|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.317|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||0.317
71919890|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.531|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||0.531
71919891|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.61|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||0.610
71919892|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||0.848
71919893|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.551|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||0.551
71919894|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||0.300
71686435|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.026|||||TWO_SIDED|95.0|-2.35|2.3|||||Comparison of AUC(0-13)|||2.30|-2.35|
71686436|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.163|||||TWO_SIDED|95.0|-2.48|2.15|||||Comparison of AUC(0-13)|||2.15|-2.48|
71919895|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.299|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||0.299
71919896|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||1.000
71919897|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||0.660
71919898|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.199|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||0.199
71919899|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||0.770
71919900|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||1.000
71919901|NCT00808132|143361485|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||0.769
71919902|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919903|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919904|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919905|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919906|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919907|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919908|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919909|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919910|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919911|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919912|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.||||< 0.001
71919913|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.||||< 0.001
71686437|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|||||TWO_SIDED|95.0|-1.88|2.21|||||Comparison of AUC(0-13)|||2.21|-1.88|
71686438|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.352|||||TWO_SIDED|95.0|-1.58|0.87|||||Comparison of iAUC(0-13)|||0.87|-1.58|
71686439|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.136|||||TWO_SIDED|95.0|-1.41|1.13|||||Comparison of iAUC(0-13)|||1.13|-1.41|
71686440|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.091|||||TWO_SIDED|95.0|-1.36|1.18|||||Comparison of iAUC(0-13)|||1.18|-1.36|
71686441|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.206|||||TWO_SIDED|95.0|-1.33|0.91|||||Comparison of iAUC(0-13)|||0.91|-1.33|
71686442|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.499|||||TWO_SIDED|95.0|-1.68|0.68|||||Comparison of iAUC(0-24)|||0.68|-1.68|
71686443|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017|||||TWO_SIDED|95.0|-1.24|1.21|||||Comparison of iAUC(0-24)|||1.21|-1.24|
71686444|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-1.44|0.95|||||Comparison of iAUC(0-24)|||0.95|-1.44|
71686445|NCT01119846|142890572|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.661|||||TWO_SIDED|95.0|-1.72|0.4|||||Comparison of iAUC(0-24)|||0.40|-1.72|
71919914|NCT00808132|143361485|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.||||< 0.001
71686446|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-49.898|||||TWO_SIDED|95.0|-479.74|379.94|||||Comparison of C-peptide, AUC 0-12|||379.94|-479.74|
71686447|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-61.642|||||TWO_SIDED|95.0|-507.32|384.04|||||Comparison of C-peptide, AUC 0-12|||384.04|-507.32|
71686448|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-85.849|||||TWO_SIDED|95.0|-530.07|358.37|||||Comparison of C-peptide, AUC 0-12|||358.37|-530.07|
71686449|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-101.422|||||TWO_SIDED|95.0|-494.09|291.25|||||Comparison of C-peptide, AUC 0-12|||291.25|-494.09|
71686450|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.239|||||TWO_SIDED|95.0|-340.32|261.85|||||Comparison of C-peptide, iAUC 0-12|||261.85|-340.32|
71686451|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-117.435|||||TWO_SIDED|95.0|-429.61|194.74|||||Comparison of C-peptide, iAUC 0-12|||194.74|-429.61|
71919915|NCT03062605|143361488|OTHER|Inequality test||||||0.35||||||Significant at p \< 0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.35
71686452|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-121.982|||||TWO_SIDED|95.0|-433.14|189.18|||||Comparison of C-peptide, iAUC 0-12|||189.18|-433.14|
71686453|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-81.016|||||TWO_SIDED|95.0|-356.07|194.03|||||Comparison of C-peptide, iAUC 0-12|||194.03|-356.07|
71919916|NCT03062605|143361488|OTHER|Inequality test||||||0.29||||||Significant at p\<0.05|McNemar|||Strep Mutans, Baseline-12 Weeks||||0.29
71686454|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.812|||||TWO_SIDED|95.0|-8.08|13.7|||||Comparison of GIP total, AUC 0-12|||13.70|-8.08|
71686455|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.023|||||TWO_SIDED|95.0|-8.27|14.32|||||Comparison of GIP total, AUC 0-12|||14.32|-8.27|
71686456|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.483|||||TWO_SIDED|95.0|0.23|22.74|||||Comparison of GIP total, AUC 0-12|||22.74|0.23|
71686457|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.093|||||TWO_SIDED|95.0|-17.04|2.86|||||Comparison of GIP total, AUC 0-12|||2.86|-17.04|
71686458|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-7.28|12.28|||||Comparison of GIP total, iAUC 0-12|||12.28|-7.28|
71686459|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.526|||||TWO_SIDED|95.0|-6.61|13.67|||||Comparison of GIP total, iAUC 0-12|||13.67|-6.61|
71686460|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.934|||||TWO_SIDED|95.0|-2.17|18.04|||||Comparison of GIP total, iAUC 0-12|||18.04|-2.17|
71919917|NCT03062605|143361488|OTHER|Inequality test||||||0.09||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.09
71686461|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.055|||||TWO_SIDED|95.0|-15.99|1.88|||||Comparison of GIP total, iAUC 0-12|||1.88|-15.99|
71686462|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.018|||||TWO_SIDED|95.0|-0.79|0.76|||||Comparison of GLP-1 active, AUC 0-12|||0.76|-0.79|
71686463|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|||||TWO_SIDED|95.0|-0.78|0.82|||||Comparison of GLP-1 active, AUC 0-12|||0.82|-0.78|
71686464|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.039|||||TWO_SIDED|95.0|-0.78|0.85|||||Comparison of GLP-1 active, AUC 0-12|||0.85|-0.78|
71686465|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.454|||||TWO_SIDED|95.0|2.74|4.17|||||Comparison of GLP-1 active, AUC 0-12|||4.17|2.74|
71686466|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|||||TWO_SIDED|95.0|-0.78|0.75|||||Comparison of GLP-1 active, iAUC 0-12|||0.75|-0.78|
71686467|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.79|0.8|||||Comparison of GLP-1 active, iAUC 0-12|||0.80|-0.79|
71686468|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.79|0.83|||||Comparison of GLP-1 active, iAUC 0-12|||0.83|-0.79|
71919918|NCT03062605|143361488|OTHER|Inequality test||||||0.13||||||Significant at p \< 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks||||0.13
71919919|NCT01009333|143361494|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Mixed Models Analysis|||||||0.008
71919920|NCT01009333|143361495|SUPERIORITY_OR_OTHER|||||||0.589||95.0|||||Mixed Models Analysis|||||||0.589
71919921|NCT01009333|143361496|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
71922423|NCT03993314|143365265|SUPERIORITY|||||||0.132||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring epidural activation between the two groups.||||0.132
71922424|NCT03993314|143365266|SUPERIORITY|||||||0.833||||||Two-sided p-value|Farrington-Manning (Score) test|||Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring supplemental IV sedation or general anesthesia between the two groups.||||0.833
71686469|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.399|||||TWO_SIDED|95.0|2.69|4.11|||||Comparison of GLP-1 active, iAUC 0-12|||4.11|2.69|
71686470|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.052|||||TWO_SIDED|95.0|-2.06|2.17|||||Comparison of GLP-1 total, AUC 0-12|||2.17|-2.06|
71686471|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.223|||||TWO_SIDED|95.0|-1.97|2.42|||||Comparison of GLP-1 total, AUC 0-12|||2.42|-1.97|
71686472|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.835|||||TWO_SIDED|95.0|-0.35|4.02|||||Comparison of GLP-1 total, AUC 0-12|||4.02|-0.35|
71686473|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.629|||||TWO_SIDED|95.0|-3.56|0.3|||||Comparison of GLP-1 total, AUC 0-12|||0.30|-3.56|
71686474|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.078|||||TWO_SIDED|95.0|-1.7|1.86|||||Comparison of GLP-1 total, iAUC 0-12|||1.86|-1.70|
71919922|NCT01948791|143361497|NON_INFERIORITY_OR_EQUIVALENCE|If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of MeanP-MeanB+1.40, the post-baseline noninferiority to baseline can be concluded. If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of 0, superiority can be concluded.|||||<|0.001|||||||t-test, 1 sided|||The hypothesis to test the non-inferiority of post-baseline change in ADAS-Cog from baseline was: H0: μP - μB ≥ 1.40, Ha: μP - μB \< 1.40 where μP and μB are the ADAS-Cog score (actual) at 16 weeks of Rivastigmine treatment and the baseline ADAS-Cog score (actual), respectively.||||<0.001
71919923|NCT02074436|143361502|OTHER|||||||0.5|TWO_SIDED|0.001|||||Fisher Exact|||The results are from the first and only interim analysis focusing on the primary endpoint: proportion of patient with major bleeding (Grade 3 and 4) during the study. The interim analysis was performed after 11 patients in each arm were randomized and results were obtained. One-sided fisher's exact test was employed in the analysis. The null hypothesis is the probability of occurring major bleeding is the same for Arm A and Arm B||||0.5
71919924|NCT03481634|143361503|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.81|<|0.001|TWO_SIDED|95.0|-2.9|0.3||1-sided p-value|ANOVA|||||0.3|-2.9|<0.001
71919925|NCT03481634|143361503|NON_INFERIORITY|Non-inferiority (4-letter margin)|LS mean difference|-3.3|STANDARD_ERROR_OF_MEAN|0.94||0.227|TWO_SIDED|95.0|-5.1|-1.4||1-sided p-value|ANOVA|||||-1.4|-5.1|0.227
71919926|NCT03481634|143361504|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.75|<|0.001|TWO_SIDED|95.0|-3.0|0.0||(1-sided)|ANOVA|||||-0.0|-3.0|<0.001
71686475|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.286|||||TWO_SIDED|95.0|-1.56|2.13|||||Comparison of GLP-1 total, iAUC 0-12|||2.13|-1.56|
71686476|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.764|||||TWO_SIDED|95.0|-1.08|2.6|||||Comparison of GLP-1 total, iAUC 0-12|||2.60|-1.08|
71686477|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.336|||||TWO_SIDED|95.0|-2.96|0.29|||||Comparison of GLP-1 total, iAUC 0-12|||0.29|-2.96|
71686478|NCT01119846|142890573|SUPERIORITY||Mean Difference (Final Values)|0.962|||||TWO_SIDED|95.0|-4.26|6.18|||||Comparison of Glucagon, AUC 0-12|||6.18|-4.26|
71686479|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.067|||||TWO_SIDED|95.0|-2.56|8.69|||||Comparison of Glucagon, AUC 0-12|||8.69|-2.56|
71686480|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.517|||||TWO_SIDED|95.0|-2.98|8.01|||||Comparison of Glucagon, AUC 0-12|||8.01|-2.98|
71686481|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.714|||||TWO_SIDED|95.0|-5.56|4.13|||||Comparison of Glucagon, AUC 0-12|||4.13|-5.56|
71686482|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.866|||||TWO_SIDED|95.0|-6.4|0.67|||||Comparison of Glucagon, iAUC 0-12|||0.67|-6.40|
71686483|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.865|||||TWO_SIDED|95.0|-4.68|2.95|||||Comparison of Glucagon, iAUC 0-12|||2.95|-4.68|
71686484|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.436|||||TWO_SIDED|95.0|-4.16|3.29|||||Comparison of Glucagon, iAUC 0-12|||3.29|-4.16|
71686485|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.573|||||TWO_SIDED|95.0|-4.86|1.71|||||Comparison of Glucagon, iAUC 0-12|||1.71|-4.86|
71686486|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.74|||||TWO_SIDED|95.0|-168.38|118.9|||||Comparison of Insulin, AUC 0-13|||118.90|-168.38|
71686487|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.229|||||TWO_SIDED|95.0|-161.16|136.7|||||Comparison of Insulin, AUC 0-13|||136.70|-161.16|
71919927|NCT03481634|143361504|NON_INFERIORITY|Non-inferiority (4-letter margin)|Mean Difference (Net)|-3.5|STANDARD_ERROR_OF_MEAN|0.9|||TWO_SIDED|95.0|-5.2|-1.7||(1-sided)|ANOVA|||||-1.7|-5.2|
71919928|NCT03481634|143361508|OTHER|Descriptive|LS mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|95.0|-6.0|-1.7|||ANOVA|||||-1.7|-6.0|
71919929|NCT03481634|143361508|OTHER|Descriptive|LS mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|95.0|-4.0|0.1|||ANOVA|||||0.1|-4.0|
71919930|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|8.68|||TWO_SIDED|95.0|-17.7|16.4|||ANOVA|||Week 4||16.4|-17.7|
71919931|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-2.1|STANDARD_ERROR_OF_MEAN|8.41|||TWO_SIDED|95.0|-18.7|14.4|||ANOVA|||Week 4||14.4|-18.7|
71686488|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.628|||||TWO_SIDED|95.0|-158.07|138.81|||||Comparison of Insulin, AUC 0-13|||138.81|-158.07|
71686489|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.936|||||TWO_SIDED|95.0|-198.15|64.28|||||Comparison of Insulin, AUC 0-13|||64.28|-198.15|
71686490|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.042|||||TWO_SIDED|95.0|-150.57|78.48|||||Comparison of Insulin, iAUC 0-13|||78.48|-150.57|
71686491|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.525|||||TWO_SIDED|95.0|-141.27|96.22|||||Comparison of Insulin, iAUC 0-13|||96.22|-141.27|
71686492|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|||||TWO_SIDED|95.0|-140.36|96.36|||||Comparison of Insulin, iAUC 0-13|||96.36|-140.36|
71686493|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.324|||||TWO_SIDED|95.0|-170.95|38.3|||||Comparison of Insulin, iAUC 0-13|||38.30|-170.95|
71686494|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.982|||||TWO_SIDED|95.0|-2.66|14.62|||||Comparison of PYY total, AUC 0-12|||14.62|-2.66|
71686495|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.908|||||TWO_SIDED|95.0|-0.05|17.86|||||Comparison of PYY total, AUC 0-12|||17.86|-0.05|
71879586|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.019|STANDARD_ERROR_OF_MEAN|0.012||0.1171|TWO_SIDED|95.0|-0.005|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.043|-0.005|0.1171
71919932|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|12.2|STANDARD_ERROR_OF_MEAN|8.87|||TWO_SIDED|95.0|-5.2|29.7|||ANOVA|||Week 6||29.7|-5.2|
71686496|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.317|||||TWO_SIDED|95.0|5.39|23.24|||||Comparison of PYY total, AUC 0-12|||23.24|5.39|
71686497|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|||||TWO_SIDED|95.0|-13.33|2.45|||||Comparison of PYY total, AUC 0-12|||2.45|-13.33|
71686498|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.999|||||TWO_SIDED|95.0|-1.87|11.87|||||Comparison of PYY total, iAUC 0-12|||11.87|-1.87|
71919933|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|2.4|STANDARD_ERROR_OF_MEAN|8.38|||TWO_SIDED|95.0|-14.0|18.9|||ANOVA|||Week 6||18.9|-14.0|
71919934|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.61|||TWO_SIDED|95.0|-16.0|17.9|||ANOVA|||Week 8||17.9|-16.0|
71686499|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.909|||||TWO_SIDED|95.0|-0.22|14.03|||||Comparison of PYY total, iAUC 0-12|||14.03|-0.22|
71686500|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.036|||||TWO_SIDED|95.0|1.93|16.14|||||Comparison of PYY total, iAUC 0-12|||16.14|1.93|
71686501|NCT01119846|142890573|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.39|||||TWO_SIDED|95.0|-12.67|-0.11|||||Comparison of PYY total, iAUC 0-12|||-0.11|-12.67|
71686502|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.564|||||TWO_SIDED|95.0|-2.69|1.56|||||Comparison of AUC 0-3|||1.56|-2.69|
71686503|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.846|||||TWO_SIDED|95.0|-3.05|1.36|||||Comparison of AUC 0-3|||1.36|-3.05|
71686504|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.175|||||TWO_SIDED|95.0|-3.37|1.02|||||Comparison of AUC 0-3|||1.02|-3.37|
71686505|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.617|||||TWO_SIDED|95.0|-2.56|1.33|||||Comparison of AUC 0-3|||1.33|-2.56|
71686506|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.626|||||TWO_SIDED|95.0|-1.64|0.39|||||Comparison of iAUC 0-3|||0.39|-1.64|
71686507|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.956|||||TWO_SIDED|95.0|-2.01|0.09|||||Comparison of iAUC 0-3|||0.09|-2.01|
71686508|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.103|||||TWO_SIDED|95.0|-2.15|-0.06|||||Comparison of iAUC 0-3|||-0.06|-2.15|
71686509|NCT01119846|142890574|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99|||||TWO_SIDED|95.0|-1.91|-0.07|||||Comparison of iAUC 0-3|||-0.07|-1.91|
71686510|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|152.962|||||TWO_SIDED|95.0|-200.57|506.49|||||Comparison of C-peptide, AUC 0-2|||506.49|-200.57|
71686511|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|113.866|||||TWO_SIDED|95.0|-252.69|480.42|||||Comparison of C-peptide, AUC 0-2|||480.42|-252.69|
71686512|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|114.474|||||TWO_SIDED|95.0|-250.89|479.83|||||Comparison of C-peptide, AUC 0-2|||479.83|-250.89|
71686513|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|136.638|||||TWO_SIDED|95.0|-186.32|459.6|||||Comparison of C-peptide, AUC 0-2|||459.60|-186.32|
71686514|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|163.622|||||TWO_SIDED|95.0|-127.31|454.55|||||Comparison of C-peptide, iAUC 0-2|||454.55|-127.31|
71686515|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.074|||||TWO_SIDED|95.0|-243.57|359.72|||||Comparison of C-peptide, iAUC 0-2|||359.72|-243.57|
71686516|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|78.341|||||TWO_SIDED|95.0|-222.32|379.0|||||Comparison of C-peptide, iAUC 0-2|||379.00|-222.32|
71686517|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|157.044|||||TWO_SIDED|95.0|-108.73|422.82|||||Comparison of C-peptide, iAUC 0-2|||422.82|-108.73|
71686518|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.539|||||TWO_SIDED|95.0|-4.79|17.87|||||Comparison of GIP total, AUC 0-2|||17.87|-4.79|
71686519|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.095|||||TWO_SIDED|95.0|-7.65|15.84|||||Comparison of GIP total, AUC 0-2|||15.84|-7.65|
71919935|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.28|||TWO_SIDED|95.0|-19.6|12.9|||ANOVA|||Week 8||12.9|-19.6|
71919936|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|6.4|STANDARD_ERROR_OF_MEAN|8.73|||TWO_SIDED|95.0|-10.7|23.6|||ANOVA|||Week 12||23.6|-10.7|
71919937|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|2.8|STANDARD_ERROR_OF_MEAN|8.85|||TWO_SIDED|95.0|-14.6|20.2|||ANOVA|||Week 12||20.2|-14.6|
71919938|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|8.5|||TWO_SIDED|95.0|-15.7|17.8|||ANOVA|||Week 16||17.8|-15.7|
71686520|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.033|||||TWO_SIDED|95.0|1.33|24.74|||||Comparison of GIP total, AUC 0-2|||24.74|1.33|
71686521|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.824|||||TWO_SIDED|95.0|-13.17|7.52|||||Comparison of GIP total, AUC 0-2|||7.52|-13.17|
71686522|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.227|||||TWO_SIDED|95.0|-3.47|15.93|||||Comparison of GIP total, iAUC 0-2|||15.93|-3.47|
71879587|NCT01431274|143278892|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.012||0.5759|TWO_SIDED|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.017|-0.031|0.5759
71919939|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.29|||TWO_SIDED|95.0|-19.7|12.9|||ANOVA|||Week 16||12.9|-19.7|
71919940|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|8.9|STANDARD_ERROR_OF_MEAN|8.92|||TWO_SIDED|95.0|-8.6|26.5|||ANOVA|||Week 18||26.5|-8.6|
71686523|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.598|||||TWO_SIDED|95.0|-5.46|14.65|||||Comparison of GIP total, iAUC 0-2|||14.65|-5.46|
71879588|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.079|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.055|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.103|0.055|<0.0001
71879589|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.038|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.086|0.038|<0.0001
71879590|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.061|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.037|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.085|0.037|<0.0001
71879591|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.012||0.0002|TWO_SIDED|95.0|0.022|0.071||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.071|0.022|0.0002
71879592|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.044|STANDARD_ERROR_OF_MEAN|0.012||0.0004|TWO_SIDED|95.0|0.019|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.068|0.019|0.0004
71919941|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|2.6|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|95.0|-14.1|19.2|||ANOVA|||Week 18||19.2|-14.1|
71919942|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-3.4|STANDARD_ERROR_OF_MEAN|8.55|||TWO_SIDED|95.0|-20.2|13.4|||ANOVA|||Week 20||13.4|-20.2|
71919943|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-5.8|STANDARD_ERROR_OF_MEAN|8.12|||TWO_SIDED|95.0|-21.7|10.2|||ANOVA|||Week 20||10.2|-21.7|
71919944|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-13.9|STANDARD_ERROR_OF_MEAN|9.06|||TWO_SIDED|95.0|-31.7|3.9|||ANOVA|||Week 24||3.9|-31.7|
71686524|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.484|||||TWO_SIDED|95.0|-0.54|19.51|||||Comparison of GIP total, iAUC 0-2|||19.51|-0.54|
71686525|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.786|||||TWO_SIDED|95.0|-11.65|6.08|||||Comparison of GIP total, iAUC 0-2|||6.08|-11.65|
71919945|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-17.8|STANDARD_ERROR_OF_MEAN|8.95|||TWO_SIDED|95.0|-35.4|-0.2|||ANOVA|||Week 24||-0.2|-35.4|
71919946|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.26|||TWO_SIDED|95.0|-25.0|7.5|||ANOVA|||Week 28||7.5|-25.0|
71919947|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-8.7|STANDARD_ERROR_OF_MEAN|8.49|||TWO_SIDED|95.0|-25.4|8.0|||ANOVA|||Week 28||8.0|-25.4|
71919948|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-3.2|STANDARD_ERROR_OF_MEAN|9.49|||TWO_SIDED|95.0|-21.8|15.5|||ANOVA|||Week 32||15.5|-21.8|
71919949|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-11.7|STANDARD_ERROR_OF_MEAN|9.02|||TWO_SIDED|95.0|-29.5|6.0|||ANOVA|||Week 32||6.0|-29.5|
71919950|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|36.3|STANDARD_ERROR_OF_MEAN|11.01|||TWO_SIDED|95.0|14.6|57.9|||ANOVA|||Week 36||57.9|14.6|
71686526|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.066|||||TWO_SIDED|95.0|-0.38|0.52|||||Comparison of GLP-1 active, AUC 0-2|||0.52|-0.38|
71686527|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.256|||||TWO_SIDED|95.0|-0.21|0.72|||||Comparison of GLP-1 active, AUC 0-2|||0.72|-0.21|
71686528|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|||||TWO_SIDED|95.0|-0.42|0.51|||||Comparison of GLP-1 active, AUC 0-2|||0.51|-0.42|
71686529|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.694|||||TWO_SIDED|95.0|2.28|3.11|||||Comparison of GLP-1 active, AUC 0-2|||3.11|2.28|
71686530|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.36|0.5|||||Comparison of GLP-1 active, iAUC 0-2|||0.50|-0.36|
71686531|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.243|||||TWO_SIDED|95.0|-0.2|0.69|||||Comparison of GLP-1 active, iAUC 0-2|||0.69|-0.20|
71686532|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|||||TWO_SIDED|95.0|-0.41|0.47|||||Comparison of GLP-1 active, iAUC 0-2|||0.47|-0.41|
71919951|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|20.4|STANDARD_ERROR_OF_MEAN|9.97|||TWO_SIDED|95.0|0.7|40.0|||ANOVA|||Week 36||40.0|0.7|
71919952|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-6.1|STANDARD_ERROR_OF_MEAN|9.19|||TWO_SIDED|95.0|-24.2|11.9|||ANOVA|||Week 40||11.9|-24.2|
71919953|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-6.5|STANDARD_ERROR_OF_MEAN|9.5|||TWO_SIDED|95.0|-25.2|12.2|||ANOVA|||Week 40||12.2|-25.2|
71919954|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|7.9|STANDARD_ERROR_OF_MEAN|9.33|||TWO_SIDED|95.0|-10.4|26.3|||ANOVA|||Week 44||26.3|-10.4|
71919955|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|1.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-16.2|18.3|||ANOVA|||Week 44||18.3|-16.2|
71919956|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|9.84|||TWO_SIDED|95.0|-5.8|32.9|||ANOVA|||Week 48||32.9|-5.8|
71686533|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.643|||||TWO_SIDED|95.0|2.25|3.04|||||Comparison of GLP-1 active, iAUC 0-2|||3.04|2.25|
71686534|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-1.44|1.55|||||Comparison of GLP-1 total, AUC 0-2|||1.55|-1.44|
71919957|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|4.7|STANDARD_ERROR_OF_MEAN|9.26|||TWO_SIDED|95.0|-13.5|23.0|||ANOVA|||Week 48||23.0|-13.5|
71686535|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|||||TWO_SIDED|95.0|-1.28|1.82|||||Comparison of GLP-1 total, AUC 0-2|||1.82|-1.28|
71686536|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.894|||||TWO_SIDED|95.0|-0.65|2.44|||||Comparison of GLP-1 total, AUC 0-2|||2.44|-0.65|
71686537|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.483|||||TWO_SIDED|95.0|-2.85|-0.12|||||Comparison of GLP-1 total, AUC 0-2|||-0.12|-2.85|
71686538|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|||||TWO_SIDED|95.0|-1.18|1.34|||||Comparison of GLP-1 total, iAUC 0-2|||1.34|-1.18|
71919958|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|4.3|STANDARD_ERROR_OF_MEAN|9.52|||TWO_SIDED|95.0|-14.5|23.0|||ANOVA|||Week 52||23.0|-14.5|
71919959|NCT03481634|143361511|OTHER|Descriptive|LS mean difference|-5.1|STANDARD_ERROR_OF_MEAN|8.78|||TWO_SIDED|95.0|-22.3|12.2|||ANOVA|||Week 52||12.2|-22.3|
71919960|NCT03481634|143361512|OTHER|Descriptive|LS mean difference|1.7|STANDARD_ERROR_OF_MEAN|9.3|||TWO_SIDED|95.0|-16.6|20.0|||ANOVA|||||20.0|-16.6|
71919961|NCT03481634|143361512|OTHER|Descriptive|LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|8.79|||TWO_SIDED|95.0|-20.7|13.8|||ANOVA|||||13.8|-20.7|
71919962|NCT03481634|143361519|OTHER|Descriptive; Week 28|Difference - %|1.6|||||TWO_SIDED|95.0|-5.3|8.4|||Bootstrap method|||||8.4|-5.3|
71919963|NCT03481634|143361519|OTHER|Descriptive; Week 28|Difference - %|4.1|||||TWO_SIDED|95.0|-2.1|10.3|||Bootstrap method|||||10.3|-2.1|
71919964|NCT03481634|143361519|OTHER|Descriptive; Week 52|Difference - %|5.8|||||TWO_SIDED|95.0|-1.2|12.4|||Bootstrap method|||||12.4|-1.2|
71919965|NCT03481634|143361519|OTHER|Descriptive; Week 52|Difference - %|6.7|||||TWO_SIDED|95.0|0.6|12.9|||Bootstrap method|||||12.9|0.6|
71919966|NCT03481634|143361519|OTHER|Descriptive: Week 76|Difference - %|2.8|||||TWO_SIDED|95.0|-3.9|9.4|||Bootstrap method|||||9.4|-3.9|
71919967|NCT03481634|143361519|OTHER|Descriptive: Week 76|Difference - %|0.7|||||TWO_SIDED|95.0|-5.7|7.0|||Bootstrap method|||||7.0|-5.7|
71919968|NCT03481634|143361519|OTHER|Descriptive: Week 100|Difference - %|1.7|||||TWO_SIDED|95.0|-5.0|8.1|||Bootstrap method|||||8.1|-5.0|
71919969|NCT03481634|143361519|OTHER|Descriptive: Week 100|Difference - %|2.2|||||TWO_SIDED|95.0|-4.0|8.4|||Bootstrap method|||||8.4|-4.0|
71919970|NCT03481634|143361521|OTHER|Descriptive; Week 28|Difference - %|-0.3|||||TWO_SIDED|95.0|-6.4|5.8|||Bootstrap method|||||5.8|-6.4|
71919971|NCT03481634|143361521|OTHER|Descriptive; Week 28|Difference - %|4.6|||||TWO_SIDED|95.0|-1.3|11.0|||Bootstrap method|||||11.0|-1.3|
71919972|NCT03481634|143361521|OTHER|Descriptive; Week 52|Difference - %|-4.2|||||TWO_SIDED|95.0|-10.2|2.2|||Bootstrap method|||||2.2|-10.2|
71919973|NCT03481634|143361521|OTHER|Descriptive; Week 52|Difference - %|3.9|||||TWO_SIDED|95.0|-2.2|10.5|||Bootstrap method|||||10.5|-2.2|
71919974|NCT03481634|143361521|OTHER|Descriptive; Week 72|Difference - %|-9.2|||||TWO_SIDED|95.0|-15.5|-2.8|||Bootstrap method|||||-2.8|-15.5|
71919975|NCT03481634|143361521|OTHER|Descriptive; Week 72|Difference - %|-2.3|||||TWO_SIDED|95.0|-8.4|4.4|||Bootstrap method|||||4.4|-8.4|
71686539|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|||||TWO_SIDED|95.0|-0.97|1.63|||||Comparison of GLP-1 total, iAUC 0-2|||1.63|-0.97|
71686540|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.177|||||TWO_SIDED|95.0|-1.48|1.12|||||Comparison of GLP-1 total, iAUC 0-2|||1.12|-1.48|
71919976|NCT03481634|143361521|OTHER|Descriptive; Week 100|Difference - %|-7.7|||||TWO_SIDED|95.0|-14.0|-1.6|||Bootstrap method|||||-1.6|-14.0|
71919977|NCT03481634|143361521|OTHER|Descriptive; Week 100|Difference - %|0.4|||||TWO_SIDED|95.0|-5.7|6.8|||Bootstrap method|||||6.8|-5.7|
71919978|NCT01955005|143361581|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p\<0.001||||<0.001
71919979|NCT01955005|143361582|SUPERIORITY_OR_OTHER||Z score|568.5||||0.73|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.73
71919980|NCT01955005|143361583|SUPERIORITY_OR_OTHER||Table Probability|0.0142||||0.02|TWO_SIDED||||||Fisher's Exact|||||||0.02
71919981|NCT02815982|143361584|SUPERIORITY||Mean Difference (Final Values)|-8.7|||<|0.05|TWO_SIDED|95.0|-14.6|-2.7|||t-test, 2 sided|||||-2.7|-14.6|<.05
71919982|NCT02815982|143361585|SUPERIORITY||Mean Difference (Final Values)|35.6|||<|0.001|TWO_SIDED|95.0|-559.0|630.2||p value was the actual signficance level|t-test, 2 sided|||We compared Post-intervention scores||630.2|-559.0|<.001
71919983|NCT02815982|143361586|SUPERIORITY||Mean Difference (Final Values)|0.47|||<|0.001|TWO_SIDED|95.0|-2.3|3.3||controlling for caregiver BMI at baseline and PCS BMI percentile at baseline|t-test, 2 sided|||We compared Post-intervention BMI||3.3|-2.3|<.001
71919984|NCT02815982|143361587|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.03|TWO_SIDED|95.0|-5.4|5.2||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||5.2|-5.4|<.03
71919985|NCT02815982|143361588|SUPERIORITY||Mean Difference (Final Values)|3.5|||<|0.09|TWO_SIDED|95.0|-4.3|11.3||p \< .05 was threshold|t-test, 2 sided|||||11.3|-4.3|<.09
71919986|NCT02815982|143361589|SUPERIORITY||Mean Difference (Final Values)|-328.6|||<|0.08|TWO_SIDED|95.0|-2868.4|2211.2||p \< .05 threshold,|t-test, 2 sided|||We compared Post-intervention scores||2211.2|-2868.4|<.08
71919987|NCT02815982|143361590|SUPERIORITY||Mean Difference (Final Values)|0.06|||<|0.0001|TWO_SIDED|95.0|0.01|0.11||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.11|.01|<.0001
71919988|NCT02815982|143361591|SUPERIORITY||Mean Difference (Final Values)|-2.85|||<|0.001|TWO_SIDED|95.0|-11.3|5.65||threshold set at p \< .05|t-test, 2 sided|||We compared Post-intervention scores||5.65|-11.3|<.001
71919989|NCT02815982|143361592|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.001|TWO_SIDED|95.0|-0.04|0.06||threshold p \< .05|t-test, 2 sided|||We compared Post-intervention scores||.06|-.04|<.001
71919990|NCT02815982|143361593|SUPERIORITY||Mean Difference (Final Values)|-348.9|||<|0.12|TWO_SIDED|95.0|-2762.5|2064.8||p \< .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores||2064.8|-2762.5|<.12
71919991|NCT00352027|143361620|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||The association of age with EFS was compared. P values from Score test were computed for the statistical significance.||||0.9970
71919992|NCT00352027|143361623|SUPERIORITY_OR_OTHER_LEGACY|||||||0.997|||||||Cox Model|||||||0.9970
71919993|NCT00352027|143361655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.265
71919994|NCT00352027|143361655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.057
71919995|NCT00352027|143361655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.079
71686541|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.19|||||TWO_SIDED|95.0|-2.34|-0.04|||||Comparison of GLP-1 total, iAUC 0-2|||-0.04|-2.34|
71919996|NCT00352027|143361655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
71919997|NCT00352027|143361655|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.680
71919998|NCT00352027|143361656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71919999|NCT00352027|143361656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71920000|NCT00352027|143361656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71920001|NCT00352027|143361656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.184
71879593|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.012||0.136|TWO_SIDED|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.042|-0.006|0.1360
71879594|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.041|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|0.041|<0.0001
71879595|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.012||0.1617|TWO_SIDED|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.041|-0.007|0.1617
71879596|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.014|STANDARD_ERROR_OF_MEAN|0.012||0.2476|TWO_SIDED|95.0|-0.01|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.039|-0.010|0.2476
71879597|NCT01431274|143278893|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.003|STANDARD_ERROR_OF_MEAN|0.012||0.8083|TWO_SIDED|95.0|-0.021|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.027|-0.021|0.8083
71879598|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.075|0.124||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.124|0.075|<0.0001
71879599|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.064|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.039|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.088|0.039|<0.0001
71879600|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.051|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.100|0.051|<0.0001
71879601|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.013||0.0001|TWO_SIDED|95.0|0.023|0.072||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.072|0.023|0.0001
71879602|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.012||0.0014|TWO_SIDED|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.064|0.015|0.0014
71879603|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.024|STANDARD_ERROR_OF_MEAN|0.012||0.0554|TWO_SIDED|95.0|-0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.048|-0.001|0.0554
71920002|NCT00352027|143361656|SUPERIORITY_OR_OTHER_LEGACY|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.563
71920003|NCT00352027|143361657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.319||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.319
71920004|NCT00352027|143361657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.010
71920005|NCT00352027|143361657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.002
71879604|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.047|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|0.047|<0.0001
71920006|NCT00352027|143361657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.015
71920007|NCT00352027|143361657|SUPERIORITY_OR_OTHER_LEGACY|||||||0.588||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.588
71920008|NCT00352027|143361658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.071
71879605|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.013||0.0041|TWO_SIDED|95.0|0.011|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.060|0.011|0.0041
71920009|NCT00352027|143361658|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
71920010|NCT00352027|143361658|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
71920011|NCT00352027|143361658|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||<0.001
71920012|NCT00352027|143361658|SUPERIORITY_OR_OTHER_LEGACY|||||||0.707||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.707
71686542|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.235|||||TWO_SIDED|95.0|-1.51|3.98|||||Comparison of Glucagon, AUC 0-2|||3.98|-1.51|
71686543|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.877|||||TWO_SIDED|95.0|0.04|5.71|||||Comparison of Glucagon, AUC 0-2|||5.71|0.04|
71920013|NCT00352027|143361659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.042||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.042
71920014|NCT00352027|143361659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.025
71920015|NCT00352027|143361659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.013
71920016|NCT00352027|143361659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.027
71686544|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.473|||||TWO_SIDED|95.0|-1.21|4.16|||||Comparison of Glucagon, AUC 0-2|||4.16|-1.21|
71879606|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.013||0.0248|TWO_SIDED|95.0|0.004|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.053|0.004|0.0248
71879607|NCT01431274|143278894|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.008|STANDARD_ERROR_OF_MEAN|0.013||0.5338|TWO_SIDED|95.0|-0.017|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.032|-0.017|0.5338
71879608|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0017|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0017
71879609|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.09|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.186|0.090|<0.0001
71879610|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.024||0.0426|TWO_SIDED|95.0|0.002|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.098|0.002|0.0426
71879611|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.074|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.170|0.074|<0.0001
71882801|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5433|STANDARD_ERROR_OF_MEAN|4.6662||0.9078|TWO_SIDED|80.0|-5.513|6.5995|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.5995|-5.513|0.9078
71882802|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1848|STANDARD_ERROR_OF_MEAN|4.7892||0.6502|TWO_SIDED|80.0|-8.403|4.0338|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.0338|-8.403|0.6502
71686545|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.274|||||TWO_SIDED|95.0|-2.2|2.74|||||Comparison of Glucagon, AUC 0-2|||2.74|-2.20|
71882803|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9029|STANDARD_ERROR_OF_MEAN|3.7234||0.809|TWO_SIDED|80.0|-5.716|3.9101|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.9101|-5.716|0.8090
71882804|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|2.4351|STANDARD_ERROR_OF_MEAN|3.8429||0.5282|TWO_SIDED|80.0|-2.532|7.4025|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.4025|-2.532|0.5282
71882805|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|25.3231|STANDARD_ERROR_OF_MEAN|18.8604||0.1848|TWO_SIDED|80.0|0.86393|49.782|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||49.782|0.86393|0.1848
71882806|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|50.4054|STANDARD_ERROR_OF_MEAN|19.481||0.0124|TWO_SIDED|80.0|25.134|75.677|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||75.677|25.134|0.0124
71882807|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|6.8658|STANDARD_ERROR_OF_MEAN|3.0205||0.0267|TWO_SIDED|80.0|2.9504|10.781|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.781|2.9504|0.0267
71882808|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|8.0855|STANDARD_ERROR_OF_MEAN|3.1677||0.0134|TWO_SIDED|80.0|3.9787|12.192|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||12.192|3.9787|0.0134
71882809|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5242|STANDARD_ERROR_OF_MEAN|3.7993||0.0152|TWO_SIDED|80.0|4.5949|14.453|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||14.453|4.5949|0.0152
71882810|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|19.9806|STANDARD_ERROR_OF_MEAN|4.1501|<|0.0001|TWO_SIDED|80.0|14.602|25.359|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||25.359|14.602|<.0001
71686546|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.177|||||TWO_SIDED|95.0|-4.92|0.56|||||Comparison of Glucagon, iAUC 0-2|||0.56|-4.92|
71686547|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.909|||||TWO_SIDED|95.0|-4.74|0.93|||||Comparison of Glucagon, iAUC 0-2|||0.93|-4.74|
71686548|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.053|||||TWO_SIDED|95.0|-3.74|1.63|||||Comparison of Glucagon, iAUC 0-2|||1.63|-3.74|
71686549|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.249|||||TWO_SIDED|95.0|-3.72|1.22|||||Comparison of Glucagon, iAUC 0-2|||1.22|-3.72|
71686550|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.389|||||TWO_SIDED|95.0|-95.82|122.59|||||Comparison of Insulin, AUC 0-3|||122.59|-95.82|
71686551|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.98|||||TWO_SIDED|95.0|-103.25|123.21|||||Comparison of Insulin, AUC 0-3|||123.21|-103.25|
71686552|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.426|||||TWO_SIDED|95.0|-80.43|145.28|||||Comparison of Insulin, AUC 0-3|||145.28|-80.43|
71686553|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.994|||||TWO_SIDED|95.0|-76.77|122.76|||||Comparison of Insulin, AUC 0-3|||122.76|-76.77|
71686554|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.088|||||TWO_SIDED|95.0|-86.79|90.97|||||Comparison of Insulin, iAUC 0-3|||90.97|-86.79|
71879612|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.111|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.063|0.159||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.159|0.063|<0.0001
71879613|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.027|STANDARD_ERROR_OF_MEAN|0.025||0.2661|TWO_SIDED|95.0|-0.021|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.021|0.2661
71920017|NCT00352027|143361659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.243||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.243
71920018|NCT00352027|143361660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.546||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.546
71920019|NCT00352027|143361660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.242||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.242
71920020|NCT00352027|143361660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
71920021|NCT00352027|143361660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.503||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.503
71686555|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.316|||||TWO_SIDED|95.0|-92.47|91.84|||||Comparison of Insulin, iAUC 0-3|||91.84|-92.47|
71686556|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.053|||||TWO_SIDED|95.0|-71.8|111.91|||||Comparison of Insulin, iAUC 0-3|||111.91|-71.80|
71686557|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.606|||||TWO_SIDED|95.0|-57.59|104.8|||||Comparison of Insulin, iAUC 0-3|||104.80|-57.59|
71686558|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.506|||||TWO_SIDED|95.0|-3.13|10.14|||||Comparison of PYY total, AUC 0-2|||10.14|-3.13|
71686559|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.295|||||TWO_SIDED|95.0|0.41|14.18|||||Comparison of PYY total, AUC 0-2|||14.18|0.41|
71686560|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.006|||||TWO_SIDED|95.0|0.15|13.87|||||Comparison of PYY total, AUC 0-2|||13.87|0.15|
71686561|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.555|||||TWO_SIDED|95.0|-8.62|3.51|||||Comparison of PYY total, AUC 0-2|||3.51|-8.62|
71686562|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.523|||||TWO_SIDED|95.0|-2.13|7.17|||||Comparison of PYY total, iAUC 0-2|||7.17|-2.13|
71686563|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.296|||||TWO_SIDED|95.0|0.47|10.12|||||Comparison of PYY total, iAUC 0-2|||10.12|0.47|
71686564|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.726|||||TWO_SIDED|95.0|-3.08|6.53|||||Comparison of PYY total, iAUC 0-2|||6.53|-3.08|
71686565|NCT01119846|142890575|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.506|||||TWO_SIDED|95.0|-7.75|0.74|||||Comparison of PYY total, iAUC 0-2|||0.74|-7.75|
71686566|NCT01119846|142890576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|||||TWO_SIDED|95.0|-0.84|1.32||||||||1.32|-0.84|
71686567|NCT01119846|142890576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.523|||||TWO_SIDED|95.0|-0.6|1.64||||||||1.64|-0.60|
71686568|NCT01119846|142890576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.053|||||TWO_SIDED|95.0|-1.17|1.06||||||||1.06|-1.17|
71686569|NCT01119846|142890576|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.81|1.16||||||||1.16|-0.81|
71686570|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|||||TWO_SIDED|95.0|-0.08|0.06|||||Comparison of G/I ratio|||0.06|-0.08|
71686571|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
71686572|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|||||TWO_SIDED|95.0|-0.07|0.07|||||Comparison of G/I ratio|||0.07|-0.07|
71686573|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|||||TWO_SIDED|95.0|-0.04|0.08|||||Comparison of G/I ratio|||0.08|-0.04|
71686574|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.269|||||TWO_SIDED|95.0|-8.31|12.85|||||Comparison of I/G ratio|||12.85|-8.31|
71686575|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.959|||||TWO_SIDED|95.0|-8.01|13.93|||||Comparison of I/G ratio|||13.93|-8.01|
71686576|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.053|||||TWO_SIDED|95.0|-4.88|16.99|||||Comparison of I/G ratio|||16.99|-4.88|
71686577|NCT01119846|142890577|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.017|||||TWO_SIDED|95.0|-5.65|13.68|||||Comparison of I/G ratio|||13.68|-5.65|
71686578|NCT01119846|142890578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.025|||||TWO_SIDED|95.0|-0.28|0.22|||||Comparison of insulin glucose index|||0.22|-0.28|
71686579|NCT01119846|142890578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|||||TWO_SIDED|95.0|-0.2|0.31|||||Comparison of insulin glucose index|||0.31|-0.20|
71920022|NCT00352027|143361660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.372
71920023|NCT00352027|143361661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.558
71920024|NCT00352027|143361661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.039
71920025|NCT00352027|143361661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
71920026|NCT00352027|143361661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.162
71920027|NCT00352027|143361662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.381||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.381
71920028|NCT00352027|143361662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.006
71920029|NCT00352027|143361662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.277||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.277
71920030|NCT00352027|143361662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.134||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.134
71920031|NCT00352027|143361663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
71920032|NCT00352027|143361663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
71920033|NCT00352027|143361663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.629
71920034|NCT00352027|143361663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.858||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.858
71920035|NCT00352027|143361664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.744||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.744
71920036|NCT00352027|143361664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.075||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.075
71920037|NCT00352027|143361664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.512||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.512
71920038|NCT00352027|143361664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.088||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.088
71920039|NCT00352027|143361665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
71920040|NCT00352027|143361665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.041
71920041|NCT00352027|143361665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
71920042|NCT00352027|143361665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.078
71920043|NCT00352027|143361666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71920044|NCT00352027|143361666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71920045|NCT00352027|143361666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71920046|NCT00352027|143361666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.739
71920047|NCT00352027|143361667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
71686580|NCT01119846|142890578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.028|||||TWO_SIDED|95.0|-0.29|0.23|||||Comparison of insulin glucose index|||0.23|-0.29|
71686581|NCT01119846|142890578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.041|||||TWO_SIDED|95.0|-0.27|0.19|||||Comparison of insulin glucose index|||0.19|-0.27|
71686582|NCT01119846|142890579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.346|||||TWO_SIDED|95.0|-2.06|1.37||||||||1.37|-2.06|
71686583|NCT01119846|142890579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.045|||||TWO_SIDED|95.0|-1.82|1.73||||||||1.73|-1.82|
71686584|NCT01119846|142890579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.388|||||TWO_SIDED|95.0|-2.16|1.38||||||||1.38|-2.16|
71686585|NCT01119846|142890579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|||||TWO_SIDED|95.0|-1.43|1.7||||||||1.70|-1.43|
71686586|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.523|||||TWO_SIDED|95.0|-3.04|2.0|||||Comparison of Day 7, 1 Hour|||2.00|-3.04|
71686587|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.569|||||TWO_SIDED|95.0|-3.07|1.94|||||Comparison of Day 7, 1 Hour|||1.94|-3.07|
71686588|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.064|||||TWO_SIDED|95.0|-0.45|4.57|||||Comparison of Day 7, 1 Hour|||4.57|-0.45|
71686589|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.316|||||TWO_SIDED|95.0|-2.19|2.82|||||Comparison of Day 7, 1 Hour|||2.82|-2.19|
71686590|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.484|||||TWO_SIDED|95.0|-3.99|1.02|||||Comparison of Day 7, 1 Hour|||1.02|-3.99|
71879614|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.102|0.198||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.198|0.102|<0.0001
71879615|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.061|STANDARD_ERROR_OF_MEAN|0.024||0.0119|TWO_SIDED|95.0|-0.109|-0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.014|-0.109|0.0119
71879616|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.073|STANDARD_ERROR_OF_MEAN|0.024||0.0029|TWO_SIDED|95.0|-0.121|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.025|-0.121|0.0029
71879617|NCT01431274|143278895|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.024||0.6408|TWO_SIDED|95.0|-0.036|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.059|-0.036|0.6408
71879618|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.173|0.27||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.270|0.173|<0.0001
71879619|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.193|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.145|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.145|<0.0001
71879620|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.185|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.136|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.233|0.136|<0.0001
71879621|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.065|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.162|0.065|<0.0001
71920048|NCT00352027|143361667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.933
71920049|NCT00352027|143361667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.051
71686591|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.795|||||TWO_SIDED|95.0|-3.27|1.68|||||Comparison of Day 7, 2 Hours|||1.68|-3.27|
71686592|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.313|||||TWO_SIDED|95.0|-2.78|2.15|||||Comparison of Day 7, 2 Hours|||2.15|-2.78|
71686593|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.441|||||TWO_SIDED|95.0|-0.03|4.91|||||Comparison of Day 7, 2 Hours|||4.91|-0.03|
71879622|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.157|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.108|0.205||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.205|0.108|<0.0001
71879623|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.037|STANDARD_ERROR_OF_MEAN|0.025||0.1355|TWO_SIDED|95.0|-0.012|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.085|-0.012|0.1355
71879624|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.151|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.102|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.199|0.102|<0.0001
71920050|NCT00352027|143361667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0779||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.0779
71920051|NCT00352027|143361668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.415||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.415
71920052|NCT00352027|143361668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
71920053|NCT00352027|143361668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.245
71920054|NCT00352027|143361668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.005
71920055|NCT00352027|143361669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.814||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.814
71920056|NCT00352027|143361669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.553||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.553
71920057|NCT00352027|143361669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.173||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.173
71920058|NCT00352027|143361669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test|||||||0.122
71920059|NCT00352027|143361670|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920060|NCT00352027|143361671|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71920061|NCT00352027|143361672|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71920062|NCT00352027|143361673|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71920063|NCT00352027|143361674|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71920064|NCT00352027|143361675|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generallized Estimating Equations (GEE)|||||||<0.001
71920065|NCT00352027|143361676|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920066|NCT00352027|143361677|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920067|NCT00352027|143361678|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920068|NCT00352027|143361679|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Generalized Estimating Equations (GEE)|||||||0.005
71920069|NCT00352027|143361680|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920070|NCT00352027|143361681|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920071|NCT00352027|143361682|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920072|NCT00352027|143361683|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920073|NCT00352027|143361684|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Generalized Estimating Equations (GEE)|||||||<0.001
71920074|NCT00352027|143361685|SUPERIORITY_OR_OTHER_LEGACY|||||||0.908|||||||Log Rank|||||||0.908
71920075|NCT00352027|143361686|SUPERIORITY_OR_OTHER_LEGACY|||||||0.178|||||||Log Rank|||||||0.178
71920076|NCT00352027|143361687|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|||||||Log Rank|||||||0.411
71920077|NCT00352027|143361689|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4318|||||||Cox Model|||||||0.4318
71920078|NCT00352027|143361690|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2199|||||||Cox Model|||||||0.2199
71920079|NCT00352027|143361691|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8946|||||||Cox Model|||||||0.8946
71920080|NCT00702949|143361696|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
71920081|NCT00702949|143361699|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.002
71920082|NCT00702949|143361700|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.||||0.009
71920083|NCT00702949|143361702|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.||||0.007
71920084|NCT01469637|143361704|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|1.15|||||TWO_SIDED|90.0|1.12|1.18|||ANOVA|||||1.18|1.12|
71920085|NCT01469637|143361705|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|1.09|1.15|||ANOVA|||||1.15|1.09|
71920086|NCT00598585|143361706|SUPERIORITY|unpaired test, the threshold for statistical significance was p= 0.05|||||<|0.05|||||||t-test, 2 sided|||||||< 0.05
71920087|NCT04491591|143361710|SUPERIORITY|||||||0.801|||||||Kruskal-Wallis|||||||0.801
71920088|NCT04491591|143361711|SUPERIORITY|||||||0.1336|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.1336
71920089|NCT04491591|143361711|SUPERIORITY|Immediate reconstruction versus delayed reconstruction||||||0.5505|||||||Fisher Exact|||||||0.5505
71920090|NCT04491591|143361711|SUPERIORITY|||||||0.6178|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.6178
71920091|NCT04491591|143361712|SUPERIORITY|||||||0.2317|||||||Fisher Exact|||||||0.2317
71920092|NCT04491591|143361713|SUPERIORITY|||||||0.1052|||||||Fisher Exact|||||||0.1052
71686594|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884|||||TWO_SIDED|95.0|-1.58|3.34|||||Comparison of Day 7, 2 Hours|||3.34|-1.58|
71686595|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.222|||||TWO_SIDED|95.0|-3.69|1.24|||||Comparison of Day 7, 2 Hours|||1.24|-3.69|
71686596|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.017|||||TWO_SIDED|95.0|-2.06|2.03|||||Comparison of Day 7, 4 Hours|||2.03|-2.06|
71686597|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.475|||||TWO_SIDED|95.0|-1.56|2.51|||||Comparison of Day 7, 4 Hours|||2.51|-1.56|
71920093|NCT04491591|143361714|OTHER||||||||||||||||||Within subjects pre/post comparison|||
71920094|NCT04491591|143361715|SUPERIORITY||||||<|0.001|||||||Kruskal-Wallis|||||||<0.001
71920095|NCT04491591|143361717|OTHER||||||||||||||||||Descriptive analysis using mean and standard deviation|||
71686598|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.512|||||TWO_SIDED|95.0|-0.53|3.55|||||Comparison of Day 7, 4 Hours|||3.55|-0.53|
71686599|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.233|||||TWO_SIDED|95.0|-0.8|3.26|||||Comparison of Day 7, 4 Hours|||3.26|-0.80|
71686600|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.011|||||TWO_SIDED|95.0|-3.05|1.02|||||Comparison of Day 7, 4 Hours|||1.02|-3.05|
71686601|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.189|||||TWO_SIDED|95.0|-3.05|2.67|||||Comparison of Day 7, 6 Hours|||2.67|-3.05|
71686602|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.456|||||TWO_SIDED|95.0|-2.39|3.3|||||Comparison of Day 7, 6 Hours|||3.30|-2.39|
71686603|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.706|||||TWO_SIDED|95.0|-0.14|5.56|||||Comparison of Day 7, 6 Hours|||5.56|-0.14|
71686604|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.062|||||TWO_SIDED|95.0|-1.78|3.91|||||Comparison of Day 7, 6 Hours|||3.91|-1.78|
71686605|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.708|||||TWO_SIDED|95.0|-5.55|0.14|||||Comparison of Day 7, 6 Hours|||0.14|-5.55|
71686606|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.147|||||TWO_SIDED|95.0|-2.41|2.7|||||Comparison of Day 7, 10 Hours|||2.70|-2.41|
71686607|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.452|||||TWO_SIDED|95.0|-2.09|2.99|||||Comparison of Day 7, 10 Hours|||2.99|-2.09|
71686608|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.418|||||TWO_SIDED|95.0|-0.13|4.96|||||Comparison of Day 7, 10 Hours|||4.96|-0.13|
71686609|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.063|||||TWO_SIDED|95.0|-1.47|3.6|||||Comparison of Day 7, 10 Hours|||3.60|-1.47|
71686610|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.509|||||TWO_SIDED|95.0|-4.05|1.03|||||Comparison of Day 7, 10 Hours|||1.03|-4.05|
71686611|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3|||||TWO_SIDED|95.0|-4.2|1.6|||||Comparison of Day 7, 12 Hours|||1.60|-4.20|
71686612|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.325|||||TWO_SIDED|95.0|-4.21|1.56|||||Comparison of Day 7, 12 Hours|||1.56|-4.21|
71686613|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0|||||TWO_SIDED|95.0|-1.89|3.89|||||Comparison of Day 7, 12 Hours|||3.89|-1.89|
71686614|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.265|||||TWO_SIDED|95.0|-3.14|2.62|||||Comparison of Day 7, 12 Hours|||2.62|-3.14|
71686615|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.516|||||TWO_SIDED|95.0|-3.4|2.37|||||Comparison of Day 7, 12 Hours|||2.37|-3.40|
71686616|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.515|||||TWO_SIDED|95.0|-2.29|1.26|||||Comparison of Day 14, 24 Hours|||1.26|-2.29|
71686617|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.225|||||TWO_SIDED|95.0|-1.99|1.55|||||Comparison of Day 14, 24 Hours|||1.55|-1.99|
71686618|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.501|||||TWO_SIDED|95.0|-1.28|2.28|||||Comparison of Day 14, 24 Hours|||2.28|-1.28|
71686619|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.168|||||TWO_SIDED|95.0|-1.98|1.65|||||Comparison of Day 14, 24 Hours|||1.65|-1.98|
71686620|NCT01119846|142890580|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.043|||||TWO_SIDED|95.0|-2.81|0.73|||||Comparison of Day 14, 24 Hours|||0.73|-2.81|
71686621|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-70.457|||||TWO_SIDED|95.0|-214.72|73.8|||||Day 7, 1 Hour|||73.80|-214.72|
71686622|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-151.722|||||TWO_SIDED|95.0|-295.98|-7.46|||||Day 7, 1 Hour|||-7.46|-295.98|
71686623|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-69.113|||||TWO_SIDED|95.0|-213.48|75.25|||||Day 7, 1 Hour|||75.25|-213.48|
71920096|NCT04491591|143361718|SUPERIORITY|||||||0.0302|||||||Kruskal-Wallis|||||||0.0302
71920097|NCT04491591|143361719|SUPERIORITY|||||||0.135|||||||Fisher Exact|||Reconstruction versus No reconstruction||||0.135
71920098|NCT04491591|143361719|SUPERIORITY|||||||0.51|||||||Fisher Exact|||Immediate reconstruction versus delayed reconstruction||||0.510
71920099|NCT04491591|143361719|SUPERIORITY|||||||0.469|||||||Fisher Exact|||Flap reconstruction versus Implant reconstruction||||0.469
71920100|NCT04491591|143361720|SUPERIORITY|||||||0.308|||||||Fisher Exact|||||||0.308
71920101|NCT04491591|143361721|SUPERIORITY|||||||0.036|||||||Fisher Exact|||||||0.036
71920102|NCT00135694|143361722|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-13.0|||||TWO_SIDED|90.0|-35.0|10.0||||||||10|-35|
71920103|NCT00135694|143361728|SUPERIORITY_OR_OTHER|||||||0.0183|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||0.0183
71920104|NCT00135694|143361729|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.||||||<0.0001
71920105|NCT00472043|143361733|SUPERIORITY||||||<|0.001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||||||<0.001
71920106|NCT00852761|143361757|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
71920107|NCT00852761|143361757|SUPERIORITY_OR_OTHER|||||||1||||||This is the result for the Day 8 analysis.|Chi-squared|||||||1.0000
71686624|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-104.468|||||TWO_SIDED|95.0|-248.72|39.78|||||Day 7, 1 Hour|||39.78|-248.72|
71686625|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-118.462|||||TWO_SIDED|95.0|-263.93|27.01|||||Day 7, 1 Hour|||27.01|-263.93|
71920108|NCT00852761|143361758|SUPERIORITY_OR_OTHER|||||||0.7298||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.7298
71920109|NCT00852761|143361758|SUPERIORITY_OR_OTHER|||||||0.006||||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.0060
71920110|NCT00852761|143361758|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||This is the result for the Day 15 analysis.|Chi-squared|||||||0.0060
71920111|NCT00852761|143361759|SUPERIORITY_OR_OTHER|||||||0.0332||||||Data apply to Day 15.|Chi-squared|||||||0.0332
71920112|NCT00852761|143361761|SUPERIORITY_OR_OTHER|||||||0.3101||95.0||||This is the result for the Day 3 analysis.|Chi-squared|||||||0.3101
71920113|NCT00852761|143361761|SUPERIORITY_OR_OTHER|||||||0.7242||95.0||||This is the result for the Day 8 analysis.|Chi-squared|||||||0.7242
71920114|NCT00852761|143361761|SUPERIORITY_OR_OTHER|||||||0.0135||||||This is the p value for day 15|Chi-squared|||||||0.0135
71920115|NCT00852761|143361763|SUPERIORITY_OR_OTHER|||||||0.1449||||||P value at day 15.|Chi-squared|||||||0.1449
71920116|NCT00852761|143361763|SUPERIORITY_OR_OTHER|||||||0.1634||||||P value at day 3.|Chi-squared|||||||0.1634
71920117|NCT00852761|143361763|SUPERIORITY_OR_OTHER|||||||0.5454||||||P value at day 8.|Chi-squared|||||||0.5454
71920118|NCT00852761|143361764|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 15.|Chi-squared|||||||0.6715
71920119|NCT00852761|143361764|SUPERIORITY_OR_OTHER|||||||0.7242||||||This is the p value for day 8.|Chi-squared|||||||0.7242
71920120|NCT00852761|143361764|SUPERIORITY_OR_OTHER|||||||0.6715||||||This is the p value for day 3.|Chi-squared|||||||0.6715
71920121|NCT00852761|143361765|SUPERIORITY_OR_OTHER|||||||0.4858||||||P value on day 8.|Chi-squared|||||||0.4858
71920122|NCT00852761|143361765|SUPERIORITY_OR_OTHER|||||||0.3001||||||P value on day 15.|Chi-squared|||||||0.3001
71920123|NCT00877890|143361779|NON_INFERIORITY_OR_EQUIVALENCE|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.138|<|0.0001|TWO_SIDED|95.0|-0.94|-0.39|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors.||Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is \<0; noninferiority if this upper limit is \<0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.||-0.39|-0.94|<.0001
71920124|NCT00877890|143361780|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of \<7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
71920125|NCT00877890|143361781|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.||||<.0001
71920126|NCT00877890|143361782|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-20.4|STANDARD_ERROR_OF_MEAN|5.57||0.0006|TWO_SIDED|95.0|-31.4|-9.5||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.||-9.5|-31.4|0.0006
71920127|NCT00877890|143361783|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED|||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of \<7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of \<=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving fasting plasma glucose target of \<=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (\<9% or \>=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.||||0.0008
71920128|NCT00877890|143361784|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|STANDARD_ERROR_OF_MEAN|0.487||0.0514|TWO_SIDED|95.0|-1.91|0.01|||ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.||0.01|-1.91|0.0514
71920129|NCT00877890|143361785|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|1.5||0.2367|TWO_SIDED|95.0|-4.7|1.2|||ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.||1.2|-4.7|0.2367
71686626|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-114.34|||||TWO_SIDED|95.0|-264.78|36.1|||||Day 7, 2 Hours|||36.10|-264.78|
71686627|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-116.462|||||TWO_SIDED|95.0|-266.9|33.98|||||Day 7, 2 Hours|||33.98|-266.90|
71686628|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.201|||||TWO_SIDED|95.0|-154.75|146.35|||||Day 7, 2 Hours|||146.35|-154.75|
71686629|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-48.27|||||TWO_SIDED|95.0|-198.7|102.16|||||Day 7, 2 Hours|||102.16|-198.70|
71686630|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-50.605|||||TWO_SIDED|95.0|-202.31|101.1|||||Day 7, 2 Hours|||101.10|-202.31|
71686631|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.231|||||TWO_SIDED|95.0|-40.84|26.38|||||Day 7, 4 Hours|||26.38|-40.84|
71686632|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.025|||||TWO_SIDED|95.0|-38.63|28.58|||||Day 7, 4 Hours|||28.58|-38.63|
71686633|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.523|||||TWO_SIDED|95.0|-24.11|43.16|||||Day 7, 4 Hours|||43.16|-24.11|
71879625|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.028|STANDARD_ERROR_OF_MEAN|0.025||0.2562|TWO_SIDED|95.0|-0.02|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.076|-0.020|0.2562
71879626|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0041|TWO_SIDED|95.0|0.022|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.119|0.022|0.0041
71686634|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.618|||||TWO_SIDED|95.0|-36.22|30.99|||||Day 7, 4 Hours|||30.99|-36.22|
71686635|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.8|||||TWO_SIDED|95.0|-13.09|54.69|||||Day 7, 4 Hours|||54.69|-13.09|
71686636|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-58.864|||||TWO_SIDED|95.0|-156.11|38.38|||||Day 7, 6 Hours|||38.38|-156.11|
71686637|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-77.9|||||TWO_SIDED|95.0|-175.15|19.35|||||Day 7, 6 Hours|||19.35|-175.15|
71686638|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|28.323|||||TWO_SIDED|95.0|-69.0|125.65|||||Day 7, 6 Hours|||125.65|-69.00|
71686639|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.499|||||TWO_SIDED|95.0|-121.74|72.74|||||Day 7, 6 Hours|||72.74|-121.74|
71686640|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-59.755|||||TWO_SIDED|95.0|-157.82|38.31|||||Day 7, 6 Hours|||38.31|-157.82|
71686641|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-69.85|69.4|||||Day 7, 10 Hours|||69.40|-69.85|
71686642|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.222|||||TWO_SIDED|95.0|-77.28|61.98|||||Day 7, 10 Hours|||61.98|-77.28|
71686643|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.148|||||TWO_SIDED|95.0|-62.55|76.85|||||Day 7, 10 Hours|||76.85|-62.55|
71686644|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.734|||||TWO_SIDED|95.0|-36.89|102.36|||||Day 7, 10 Hours|||102.36|-36.89|
71686645|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.76|||||TWO_SIDED|95.0|-81.01|61.49|||||Day 7, 10 Hours|||61.49|-81.01|
71686646|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.594|||||TWO_SIDED|95.0|-123.36|84.18|||||Day 7, 12 Hours|||84.18|-123.36|
71686647|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.924|||||TWO_SIDED|95.0|-150.69|56.85|||||Day 7, 12 Hours|||56.85|-150.69|
71686648|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.715|||||TWO_SIDED|95.0|-79.16|128.59|||||Day 7, 12 Hours|||128.59|-79.16|
71686649|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.966|||||TWO_SIDED|95.0|-111.73|95.8|||||Day 7, 12 Hours|||95.80|-111.73|
71686650|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.108|||||TWO_SIDED|95.0|-103.08|109.29|||||Day 7, 12 Hours|||109.29|-103.08|
71686651|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.114|||||TWO_SIDED|95.0|-25.12|4.89|||||Day 14, 24 Hours|||4.89|-25.12|
71686652|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.718|||||TWO_SIDED|95.0|-23.71|6.28|||||Day 14, 24 Hours|||6.28|-23.71|
71686653|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.622|||||TWO_SIDED|95.0|-15.63|14.38|||||Day 14, 24 Hours|||14.38|-15.63|
71686654|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.454|||||TWO_SIDED|95.0|-27.78|2.88|||||Day 14, 24 Hours|||2.88|-27.78|
71686655|NCT01119846|142890581|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.681|||||TWO_SIDED|95.0|-24.02|6.66|||||Day 14, 24 Hours|||6.66|-24.02|
71686656|NCT00795769|142890597|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 1 sided|||18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.||||0.03
71686657|NCT00795769|142890597|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 1 sided|||Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p \<0.0001). PMID: 21372706 reference for historical data at FHCRC||||<0.0001
71686658|NCT01370616|142890598|NON_INFERIORITY_OR_EQUIVALENCE|If the 95% confidence interval for the estimated difference between the two groups has a lower bound greater than -15%, then ertapenem sodium will be considered at least as effective as piperacillin/tazobactam sodium.|Estimated Difference|-3.8|||||TWO_SIDED|95.0|-8.3|0.0|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||0.0|-8.3|
71879627|NCT01431274|143278896|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.043|STANDARD_ERROR_OF_MEAN|0.025||0.0815|TWO_SIDED|95.0|-0.091|0.005||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.005|-0.091|0.0815
71879628|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.195|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.149|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.149|<0.0001
71879629|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.107|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.199|0.107|<0.0001
71879630|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.174|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.128|0.221||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.221|0.128|<0.0001
71920130|NCT00877890|143361786|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.98||0.7717|TWO_SIDED|95.0|-1.7|2.2|||ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.||2.2|-1.7|0.7717
71920131|NCT00877890|143361787|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.5|<|0.0001|TWO_SIDED|95.0|-22.9|-9.1|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.||-9.1|-22.9|<.0001
71686659|NCT01370616|142890599|SUPERIORITY_OR_OTHER||Estimated Difference|-1.7|||||TWO_SIDED|95.0|-5.5|1.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||1.8|-5.5|
71686660|NCT01370616|142890600|SUPERIORITY_OR_OTHER||Estimated Difference|-2.3|||||TWO_SIDED|95.0|-7.7|2.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||2.8|-7.7|
71686661|NCT01370616|142890601|SUPERIORITY_OR_OTHER||Estimated Difference|-4.1|||||TWO_SIDED|95.0|-11.9|3.4|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.4|-11.9|
71686662|NCT01370616|142890602|SUPERIORITY_OR_OTHER||Estimated Difference|-4.3|||||TWO_SIDED|95.0|-12.1|3.3|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen \& Nurminen method stratified by the severity of diabetes foot infection.|||3.3|-12.1|
71686663|NCT01370616|142890603|SUPERIORITY_OR_OTHER||Estimated Difference|7.3|||||TWO_SIDED|95.0|-0.9|15.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||15.4|-0.9|
71686664|NCT01370616|142890604|SUPERIORITY_OR_OTHER||Estimated Difference|-2.5|||||TWO_SIDED|95.0|-8.5|3.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||3.4|-8.5|
71686665|NCT01370616|142890605|SUPERIORITY_OR_OTHER||Estimated Difference|1.8|||||TWO_SIDED|95.0|-2.0|5.8|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||5.8|-2.0|
71686666|NCT01370616|142890606|SUPERIORITY_OR_OTHER||Estimated Difference|-1.8|||||TWO_SIDED|95.0|-5.7|1.9|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen \& Nurminen method without adjusting strata.|||1.9|-5.7|
71686667|NCT00212264|142890611|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||ANOVA|||||||.001
71686668|NCT00212264|142890612|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 1 sided|Note that the no-treatment control group completed the study after 2 months and was not included in this analysis of treatment effect durability.||||||.32
71686669|NCT02033200|142890638|SUPERIORITY_OR_OTHER||LS mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.335||0.8216|TWO_SIDED|95.0|-0.592|0.744|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.744|-0.592|0.8216
71686670|NCT02033200|142890638|SUPERIORITY_OR_OTHER||LS means difference|0.257|STANDARD_ERROR_OF_MEAN|0.258||0.324|TWO_SIDED|95.0|-0.258|0.771|||ANCOVA|||The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.||0.771|-0.258|0.324
71686671|NCT02033200|142890639|SUPERIORITY_OR_OTHER||LS means difference|0.004|STANDARD_ERROR_OF_MEAN|0.014||0.7864|TWO_SIDED|95.0|-0.024|0.031|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||0.031|-0.024|0.7864
71686672|NCT02033200|142890639|SUPERIORITY_OR_OTHER||LS Means difference|-0.022|STANDARD_ERROR_OF_MEAN|0.017||0.1953|TWO_SIDED|95.0|-0.056|0.012|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.012|-0.056|0.1953
71686673|NCT02033200|142890640|SUPERIORITY_OR_OTHER||LS means difference|-0.16|STANDARD_ERROR_OF_MEAN|0.061||0.0101|TWO_SIDED|95.0|-0.28|-0.039|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.||-0.039|-0.280|0.0101
71686674|NCT02033200|142890640|SUPERIORITY_OR_OTHER||LS means difference|-0.087|STANDARD_ERROR_OF_MEAN|0.061||0.1583|TWO_SIDED|95.0|-0.209|0.035|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.||0.035|-0.209|0.1583
71686675|NCT02033200|142890641|SUPERIORITY_OR_OTHER||LS means difference|-0.031|STANDARD_ERROR_OF_MEAN|0.359||0.9324|TWO_SIDED|95.0|-0.746|0.685|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.||0.685|-0.746|0.9324
71686676|NCT02033200|142890641|SUPERIORITY_OR_OTHER||LS means difference|0.751|STANDARD_ERROR_OF_MEAN|0.348||0.0343|TWO_SIDED|95.0|0.057|1.44|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.||1.44|0.057|0.0343
71686677|NCT02033200|142890642|SUPERIORITY_OR_OTHER||LS Means difference|0.017|STANDARD_ERROR_OF_MEAN|0.017||0.3139|TWO_SIDED|95.0|-0.017|0.051|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.051|-0.017|0.3139
71686678|NCT02033200|142890642|SUPERIORITY_OR_OTHER||LS means difference|-0.002|STANDARD_ERROR_OF_MEAN|0.022||0.9334|TWO_SIDED|95.0|-0.045|0.042|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.042|-0.045|0.9334
71686679|NCT02033200|142890643|SUPERIORITY_OR_OTHER||LS means difference|0.016|STANDARD_ERROR_OF_MEAN|0.055||0.7723|TWO_SIDED|95.0|-0.093|0.125|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.125|-0.093|0.7723
71686680|NCT02033200|142890643|SUPERIORITY_OR_OTHER||LS means difference|0.007|STANDARD_ERROR_OF_MEAN|0.058||0.9107|TWO_SIDED|95.0|-0.109|0.122|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.122|-0.109|0.9107
71686681|NCT02033200|142890644|SUPERIORITY_OR_OTHER||LS Means difference|-0.078|STANDARD_ERROR_OF_MEAN|0.278||0.7787|TWO_SIDED|95.0|-0.632|0.475|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.||0.475|-0.632|0.7787
71686682|NCT02033200|142890644|SUPERIORITY_OR_OTHER||LS means difference|-0.18|STANDARD_ERROR_OF_MEAN|0.344||0.6013|TWO_SIDED|95.0|-0.865|0.504|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.||0.504|-0.865|0.6013
71686683|NCT02033200|142890645|SUPERIORITY_OR_OTHER||LS means difference|0.091|STANDARD_ERROR_OF_MEAN|0.4||0.8209|TWO_SIDED|95.0|-0.705|0.887|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.||0.887|-0.705|0.8209
71920132|NCT00877890|143361788|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.8||0.1251|TWO_SIDED|95.0|-2.8|0.3|||ANCOVA|||Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.||0.3|-2.8|0.1251
71920133|NCT00877890|143361789|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|0.95|STANDARD_ERROR_OF_MEAN|0.043||0.2558|TWO_SIDED|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (\<9% or \>=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.||1.04|0.87|0.2558
71920134|NCT02109939|143361834|SUPERIORITY||Mean Difference (Net)|-2.836|STANDARD_ERROR_OF_MEAN|1.758||0.107|TWO_SIDED|95.0|-6.285|0.613|||Mixed Models Analysis|Repeated Measures including week 4.||||0.613|-6.285|0.1070
71920135|NCT02109939|143361835|SUPERIORITY||Mean Difference (Net)|-2.207|STANDARD_ERROR_OF_MEAN|1.653||0.1822|TWO_SIDED|95.0|-5.45|1.036|||Mixed Models Analysis|MMRM with week 4 data.||||1.036|-5.450|0.1822
71920136|NCT02109939|143361836|SUPERIORITY||Odds Ratio (OR)|1.41||||0.0134|TWO_SIDED|95.0|1.07|1.86|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.86|1.07|0.0134
71920137|NCT02109939|143361839|SUPERIORITY||Odds Ratio (OR)|1.61||||0.0066|TWO_SIDED|95.0|1.14|2.27|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||2.27|1.14|0.0066
71920138|NCT02109939|143361842|SUPERIORITY||Odds Ratio (OR)|1.13||||0.2852|TWO_SIDED|95.0|0.9|1.43|||Generalized linear mixed model.|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.43|0.90|0.2852
71920139|NCT02109939|143361843|SUPERIORITY||Odds Ratio (OR)|1.43||||0.0023|TWO_SIDED|95.0|1.14|1.79|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.79|1.14|0.0023
71920140|NCT02109939|143361852|SUPERIORITY||Odds Ratio (OR)|1.43||||0.014|TWO_SIDED|95.0|1.07|1.89|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.89|1.07|0.0140
71920141|NCT02109939|143361853|SUPERIORITY||Odds Ratio (OR)|1.31||||0.0663|TWO_SIDED|95.0|0.98|1.76|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.||||1.76|0.98|0.0663
71920142|NCT00606021|143361866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.1815|TWO_SIDED|95.0|0.42|1.37||The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.37|0.42|0.1815
71920143|NCT00606021|143361867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.1233|TWO_SIDED|95.0|0.4|1.26||The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||1.26|0.40|0.1233
71920144|NCT00606021|143361868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.7239|TWO_SIDED|95.0|0.56|2.28||The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.28|0.56|0.7239
71920145|NCT00606021|143361869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.18||||0.6376|TWO_SIDED|95.0|0.59|2.38||The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.||||2.38|0.59|0.6376
71920146|NCT01021293|143361935|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
71920147|NCT01021293|143361935|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV||1.24|-1.28|
71920148|NCT01021293|143361935|NON_INFERIORITY|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference \[Control Group minus Poliorix Group\] in the percentage of seroprotected subjects|Difference in seroprotection rate|-1.69|||||TWO_SIDED|95.0|-3.9|-0.44||||||Non-inferiority of Poliorix™ as compared to OPV||-0.44|-3.9|
71920149|NCT01005966|143361951|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.01||||0.2117|TWO_SIDED|95.0|-7.75|1.73||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.||1.73|-7.75|0.2117
71922425|NCT03993314|143365267|SUPERIORITY|||||||0.004||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.004
71879631|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.061|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.154|0.061|<0.0001
71879632|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.086|0.178||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.178|0.086|<0.0001
71879633|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3727|TWO_SIDED|95.0|-0.025|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.067|-0.025|0.3727
71879634|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.082|0.175||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.175|0.082|<0.0001
71879635|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.042|STANDARD_ERROR_OF_MEAN|0.024||0.0744|TWO_SIDED|95.0|-0.004|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.004|0.0744
71879636|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.067|STANDARD_ERROR_OF_MEAN|0.024||0.0047|TWO_SIDED|95.0|0.021|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.021|0.0047
71879637|NCT01431274|143278897|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.025|STANDARD_ERROR_OF_MEAN|0.024||0.2945|TWO_SIDED|95.0|-0.071|0.022||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.022|-0.071|0.2945
71879638|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.205|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.155|0.255||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.255|0.155|<0.0001
71879639|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.107|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.206|0.107|<0.0001
71879640|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.142|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.242|0.142|<0.0001
71879641|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.124|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.074|0.174||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.174|0.074|<0.0001
71879642|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.144|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.193|0.094|<0.0001
71879643|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.013|STANDARD_ERROR_OF_MEAN|0.025||0.6103|TWO_SIDED|95.0|-0.037|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.062|-0.037|0.6103
71879644|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.087|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.186|0.087|<0.0001
71879645|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.049|STANDARD_ERROR_OF_MEAN|0.025||0.0559|TWO_SIDED|95.0|-0.001|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.001|0.0559
71686684|NCT02033200|142890645|SUPERIORITY_OR_OTHER||LS means difference|0.227|STANDARD_ERROR_OF_MEAN|0.33||0.4931|TWO_SIDED|95.0|-0.43|0.884|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.||0.884|-0.430|0.4931
71686685|NCT02670382|142890646|SUPERIORITY||mean values, log transformed|||||0.33|||||||Mixed Models Analysis|||||||0.33
71686686|NCT02670382|142890646|SUPERIORITY||mean difference, log transformed values|||||0.92|||||||Mixed Models Analysis|||||||0.92
71686687|NCT02670382|142890646|SUPERIORITY||mean difference, log transformed values|||||0.44|||||||Mixed Models Analysis|||||||0.44
71686688|NCT02670382|142890647|SUPERIORITY||mean difference, log transformed values|||||0.34|||||||Mixed Models Analysis|||||||0.34
71686689|NCT02670382|142890647|SUPERIORITY||mean difference, log transformed values|||||0.5|||||||Mixed Models Analysis|||||||0.50
71686690|NCT02670382|142890647|SUPERIORITY||mean differences, log transformed values|||||0.83|||||||Mixed Models Analysis|||||||0.83
71686691|NCT02670382|142890648|EQUIVALENCE|primary hypothesis is that EPA will not differ from placebo|mean differences|||||0.1|||||||Mixed Models Analysis|||||||0.10
71686692|NCT02670382|142890648|SUPERIORITY||mean difference|||||0.005|||||||Mixed Models Analysis|||||||0.005
71686693|NCT02670382|142890648|SUPERIORITY|||||||0.17|||||||Mixed Models Analysis|||||||0.17
71686694|NCT03244618|142890649|SUPERIORITY||Mean Difference (Final Values)|-0.544|||<|0.001|TWO_SIDED|95.0|-0.712|-0.377|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours first named toothpaste.|||-0.377|-0.712|<0.001
71686695|NCT03244618|142890650|SUPERIORITY||Mean Difference (Final Values)|10.8|||<|0.001|TWO_SIDED|95.0|7.5|14.0|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first names toothpaste minus second named toothpaste such that a positive difference favours the first named toothpaste.|||14.0|7.5|<0.001
71686696|NCT03244618|142890651|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.001|TWO_SIDED|95.0|-16.4|-5.5|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.5|-16.4|<0.001
71686697|NCT03244618|142890652|SUPERIORITY||Mean Difference (Final Values)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.85|-0.489|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative value favours the first named toothpaste.|||-0.489|-0.850|<0.001
71882811|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.7667|STANDARD_ERROR_OF_MEAN|2.9402||0.3516|TWO_SIDED|80.0|-6.59|1.0562|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||1.0562|-6.590|0.3516
71686698|NCT03244618|142890653|SUPERIORITY||Mean Difference (Final Values)|11.9|||<|0.001|TWO_SIDED|95.0|8.6|15.1|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a positive difference favours first named toothpaste|||15.1|8.6|<0.001
71686699|NCT03244618|142890654|SUPERIORITY||Mean Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-16.6|-5.2|||ANOVA|ANOVA model had treatment and gender as factors.|Difference is first named toothpaste minus second named toothpaste such that a negative difference favours the first named toothpaste.|||-5.2|-16.6|<0.001
71686700|NCT03597139|142890677|SUPERIORITY||Mean Difference (Final Values)|4.6||||0.1491|TWO_SIDED|95.0|-1.7|10.9|||ANCOVA|||||10.9|-1.7|0.1491
71686701|NCT03597139|142890678|SUPERIORITY||Mean Difference (Final Values)|6.1||||0.1187|TWO_SIDED|95.0|-1.6|13.9|||ANCOVA|||||13.9|-1.6|0.1187
71686702|NCT03597139|142890679|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.2128|TWO_SIDED|95.0|-3.7|16.5|||ANCOVA|||||16.5|-3.7|0.2128
71686703|NCT03597139|142890680|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.8408|TWO_SIDED|95.0|-11.8|9.6|||ANCOVA|||||9.6|-11.8|0.8408
71686704|NCT03597139|142890681|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.5356|TWO_SIDED|95.0|-6.1|11.6|||ANCOVA|||||11.6|-6.1|0.5356
71686705|NCT03597139|142890682|SUPERIORITY||Mean Difference (Final Values)|5.7||||0.1787|TWO_SIDED|95.0|-2.7|14.1|||ANCOVA|||||14.1|-2.7|0.1787
71686706|NCT03597139|142890683|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.7666|TWO_SIDED|95.0|-12.6|9.3|||ANCOVA|||||9.3|-12.6|0.7666
71686707|NCT03597139|142890684|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.8082|TWO_SIDED|95.0|-10.7|8.4|||ANCOVA|||||8.4|-10.7|0.8082
71686708|NCT03597139|142890685|SUPERIORITY||Mean Difference (Final Values)|11.6||||0.6362|TWO_SIDED|95.0|-37.0|60.3|||ANCOVA|||||60.3|-37|0.6362
71686709|NCT03597139|142890686|SUPERIORITY||Mean Difference (Final Values)|9.6||||0.0961|TWO_SIDED|95.0|-1.7|20.9||Frequency|ANCOVA|||Frequency||20.9|-1.7|0.0961
71686710|NCT03597139|142890686|SUPERIORITY||Mean Difference (Final Values)|7.7||||0.1722|TWO_SIDED|95.0|-3.4|18.7|||ANCOVA|||Severity||18.7|-3.4|0.1722
71686711|NCT03597139|142890687|SUPERIORITY||Mean Difference (Final Values)|5.2||||0.0051|TWO_SIDED|95.0|1.6|8.9||Left Eye|ANCOVA|||Left Eye||8.9|1.6|0.0051
71686712|NCT03597139|142890687|SUPERIORITY||Mean Difference (Final Values)|4.8||||0.0104|TWO_SIDED|95.0|1.1|8.4||Right Eye|ANCOVA|||Right Eye||8.4|1.1|0.0104
71686713|NCT03597139|142890688|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.0003|TWO_SIDED|95.0|-3.2|-1.0||Left Eye|ANCOVA||Add in RE LE info|Left Eye||-1.0|-3.2|0.0003
71686714|NCT03597139|142890688|SUPERIORITY||Mean Difference (Final Values)|-1.6||||0.0038|TWO_SIDED|95.0|-2.6|-0.5||Right Eye|ANCOVA|||Right Eye||-0.5|-2.6|0.0038
71686715|NCT00410072|142890774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||0.0882|TWO_SIDED|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|||Week 96||14.9|-1.0|0.0882
71686716|NCT00410072|142890775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.5|||||TWO_SIDED|95.0|2.3|24.8|||NC=F|||||24.8|2.3|
71686717|NCT00410072|142890775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-7.7|12.0|||NC=F|||||12.0|-7.7|
71882812|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|3.0838|STANDARD_ERROR_OF_MEAN|3.2323||0.3448|TWO_SIDED|80.0|-1.116|7.2838|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.2838|-1.116|0.3448
71686718|NCT00410072|142890775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.6||||0.046|TWO_SIDED|95.0|0.2|21.0|||Cochran-Mantel-Haenszel|||||21.0|0.2|0.0460
71686719|NCT00410072|142890775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-12.0|9.5|||NC=F|||||9.5|-12.0|
71920150|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.96||||0.0002|TWO_SIDED|95.0|4.27|13.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||13.66|4.27|0.0002
71920151|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.57||||0.0557||95.0|-0.11|9.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||9.24|-0.11|0.0557
71920152|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|23.55|||<|0.0001|TWO_SIDED|95.0|18.86|28.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||28.24|18.86|<0.0001
71920153|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.4||||0.0625|TWO_SIDED|95.0|-0.23|9.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||9.03|-0.23|0.0625
71920154|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|18.99|||<|0.0001|TWO_SIDED|95.0|14.36|23.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||23.61|14.36|<0.0001
71920155|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.59|||<|0.0001|TWO_SIDED|95.0|9.95|19.23||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||19.23|9.95|<0.0001
71920156|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.58||||0.0017|TWO_SIDED|95.0|2.88|12.27||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.||12.27|2.88|0.0017
71920157|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.97|||<|0.0001|TWO_SIDED|95.0|7.31|16.64||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.||16.64|7.31|<0.0001
71920158|NCT01005966|143361952|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|26.56|||<|0.0001|TWO_SIDED|95.0|21.88|31.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.||31.24|21.88|<0.0001
71920159|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|37.24||||0.7912|TWO_SIDED|95.0|-239.62|314.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.||314.09|-239.62|0.7912
71920160|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|532.61||||0.0002|TWO_SIDED|95.0|259.06|806.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.||806.16|259.06|0.0002
71920161|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|692.91|||<|0.0001|TWO_SIDED|95.0|418.73|967.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||967.09|418.73|<0.0001
71922426|NCT03993314|143365268|SUPERIORITY|||||||0.674||||||Two-sided p-value|Wilcoxon (Mann-Whitney)|Test performed was an exact test; no continuity correction was used.||Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.||||0.674
71686720|NCT00410072|142890776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.8|16.0|||NC=F|||Analysis at week 48. The stratified analysis was based on HBeAg strata at randomization.||16.0|-1.8|
71686721|NCT00410072|142890776|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.1|||||TWO_SIDED|95.0|-1.1|15.2|||NC=F|||Analysis at week 96. The stratified analysis was based on HBeAg strata at randomization.||15.2|-1.1|
71920162|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1879.4|||<|0.0001|TWO_SIDED|95.0|1605.75|2153.04||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2153.04|1605.75|<0.0001
71920163|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|495.38||||0.0005|TWO_SIDED|95.0|221.09|769.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.||769.66|221.09|0.0005
71920164|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|655.67|||<|0.0001|TWO_SIDED|95.0|382.41|928.93||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||928.93|382.41|<0.0001
71920165|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1842.16|||<|0.0001|TWO_SIDED|95.0|1568.73|2115.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||2115.60|1568.73|<0.0001
71920166|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|160.3||||0.2448|TWO_SIDED|95.0|-110.58|431.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.||431.18|-110.58|0.2448
71920167|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1346.79|||<|0.0001|TWO_SIDED|95.0|1076.46|1617.11||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1617.11|1076.46|<0.0001
71920168|NCT01005966|143361953|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1186.49|||<|0.0001|TWO_SIDED|95.0|915.38|1457.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.||1457.60|915.38|<0.0001
71920169|NCT01451203|143361954|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann point estimate of shift|0.0|||<|0.001|TWO_SIDED|95.0|0.0|0.0||The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.|ANCOVA|||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 52.The primary Week 52 analysis assessed whether treatment up to Week 52 with the CZP group was superior to the placebo group in mTSS at Week 52. The 2-sided null and alternative hypotheses were: H0: πC = πM Ha: πC ≠ πM where πC represented subjects in the CZP group at Week 52 and πM represented subjects in the placebo group at Week 52.||0.00|0.00|<0.001
71920170|NCT01451203|143361955|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman point estimate of shift|0.0||||0.003|TWO_SIDED|95.0|0.0|0.0|||ANCOVA|The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 24.||0.00|0.00|0.003
71920171|NCT01451203|143361956|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71920172|NCT01451203|143361957|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71920173|NCT01451203|143361958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED||||||Fisher Exact|||||||0.002
71920174|NCT03521089|143361975|SUPERIORITY|||||||0.0039|||||||ANCOVA|||||||0.0039
71920175|NCT03521089|143361975|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.00
71920176|NCT03521089|143361975|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
71920177|NCT03521089|143361976|SUPERIORITY|||||||0.9674|||||||ANCOVA|||||||0.9674
71920178|NCT03521089|143361976|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
71920179|NCT03521089|143361976|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.2500
71920180|NCT03521089|143361977|SUPERIORITY|||||||0.0067|||||||ANCOVA|||||||0.0067
71920181|NCT03521089|143361977|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71920182|NCT03521089|143361977|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.7500
71920183|NCT03521089|143361978|SUPERIORITY|||||||0.3069|||||||ANCOVA|||||||0.3069
71920184|NCT03521089|143361978|SUPERIORITY|||||||0.1875|||||||Wilcoxon (Mann-Whitney)|||||||0.1875
71920185|NCT03521089|143361978|SUPERIORITY|||||||0.7188|||||||Wilcoxon (Mann-Whitney)|||||||0.7188
71920186|NCT03521089|143361979|SUPERIORITY|||||||0.2609|||||||ANCOVA|||||||0.2609
71920187|NCT03521089|143361979|SUPERIORITY|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71920188|NCT03521089|143361979|SUPERIORITY|||||||0.0156|||||||Wilcoxon (Mann-Whitney)|||||||0.0156
71920189|NCT03521089|143361980|SUPERIORITY|||||||0.6951|||||||ANCOVA|||||||0.6951
71920190|NCT03521089|143361980|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
71879646|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.025||0.0073|TWO_SIDED|95.0|0.018|0.118||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.118|0.018|0.0073
71879647|NCT01431274|143278898|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.02|STANDARD_DEVIATION|0.025||0.4368|TWO_SIDED|95.0|-0.07|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.030|-0.070|0.4368
71879648|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.147|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.196|0.098|<0.0001
71879649|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0023|TWO_SIDED|95.0|0.027|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.027|0.0023
71879650|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
71879651|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.025||0.0545|TWO_SIDED|95.0|-0.001|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 μg).~Spatial power covariance structure for within-patient errors."|||0.097|-0.001|0.0545
71879652|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.05|STANDARD_ERROR_OF_MEAN|0.025||0.0456|TWO_SIDED|95.0|0.001|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.099|0.001|0.0456
71879653|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.026|STANDARD_ERROR_OF_MEAN|0.025||0.2949|TWO_SIDED|95.0|-0.023|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.075|-0.023|0.2949
71879654|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.074|STANDARD_ERROR_OF_MEAN|0.025||0.0029|TWO_SIDED|95.0|0.025|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.123|0.025|0.0029
71879655|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.025||0.0045|TWO_SIDED|95.0|0.022|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.120|0.022|0.0045
71879656|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.073|STANDARD_ERROR_OF_MEAN|0.025||0.0035|TWO_SIDED|95.0|0.024|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.122|0.024|0.0035
71920191|NCT03521089|143361980|SUPERIORITY|||||||0.0938|||||||Wilcoxon (Mann-Whitney)|||||||0.0938
71920192|NCT03521089|143361981|SUPERIORITY|||||||0.3592|||||||ANCOVA|||||||0.3592
71920193|NCT03521089|143361981|SUPERIORITY|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71920194|NCT03521089|143361981|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71920195|NCT05064449|143362002|OTHER||Geometric Mean Ratio (%)|116.59|||||TWO_SIDED|90.0|91.3|148.9|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90 percent (%) confidence intervals (CIs) for the geometric mean ratio (GMR) of Cmax for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||148.90|91.30|
71922427|NCT03993314|143365269|SUPERIORITY|||||||0.196|||||||Log Rank|||Log-rank test of the null hypothesis that there is no difference in the time to discharge from the Post Anesthesia Care Unit (PACU) between the two groups.||||0.196
71920196|NCT05064449|143362003|OTHER||Geometric Mean Ratio (%)|107.31|||||TWO_SIDED|90.0|88.02|130.83|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of Cmax for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed Cmax.||130.83|88.02|
71920197|NCT05064449|143362004|OTHER||Geometric Mean Ratio (%)|123.96|||||TWO_SIDED|90.0|106.21|144.68|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||144.68|106.21|
71920198|NCT05064449|143362005|OTHER||Geometric Mean Ratio (%)|100.57|||||TWO_SIDED|90.0|86.17|117.38|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUC∞ for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUC∞.||117.38|86.17|
71920199|NCT05064449|143362006|OTHER||Geometric Mean Ratio (%)|121.97|||||TWO_SIDED|90.0|103.47|143.79|||||GMR (%) was calculated as 100\*(Soticlestat + Itraconazole / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without itraconazole were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||143.79|103.47|
71920200|NCT05064449|143362007|OTHER||Geometric Mean Ratio (%)|107.38|||||TWO_SIDED|90.0|91.68|125.77|||||GMR (%) was calculated as 100\*(Soticlestat + Mefenamic Acid / Soticlestat Alone).|Linear mixed-effects model was used for analysis, using fixed-effect (treatment), random-effect (participants). The point estimates and the 90% CIs for the GMR of AUClast for soticlestat with versus without mefenamic acid were calculated by exponentiation of the point estimates of the differences between treatments and the corresponding 90% CIs from the analyses on the ln-transformed AUClast.||125.77|91.68|
71920201|NCT05064449|143362008|OTHER||Median Difference (Final Values)|0.003|||=|0.2305|TWO_SIDED|90.0|-0.001|0.126|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Itraconazole) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% CI was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.126|-0.001|=0.2305
71920202|NCT05064449|143362009|OTHER||Median Difference (Final Values)|-0.096|||=|0.583|TWO_SIDED|90.0|-0.128|0.018|||Wilcoxon Signed Rank Test||Difference was calculated as (Soticlestat + Mefenamic Acid) - Soticlestat Alone. The difference of medians (treatment effect) and the corresponding 90% was estimated using the Hodges-Lehmann method and Walsh Averages.|||0.018|-0.128|=0.5830
71920203|NCT01722552|143362028|EQUIVALENCE|The margin for non-equivalence was 25 percentage points.|Risk Ratio (RR)|1.59|||<|0.05|TWO_SIDED|95.0|1.21|2.1|||Chi-squared|||The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.||2.1|1.21|<0.05
71920204|NCT00732199|143362035|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||T- test was conducted to compare the 2 groups.||||<0.05
71920205|NCT00732199|143362036|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|Compares control vs hypoxia trials vs recovery post-hypoxia||||||<0.05
71920206|NCT00732199|143362037|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71920207|NCT00732199|143362038|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71920208|NCT00147082|143362057|SUPERIORITY|||||||0.05||||||The threshold for significance was p\<0.05|Kruskal-Wallis|||p values were calculated||||0.05
71920209|NCT00147082|143362058|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||p value was calculated||||0.05
71920210|NCT00147082|143362059|SUPERIORITY|||||||0.05||||||The p value (\<0.05) was the threshold for significance|Kruskal-Wallis|||The p value was calculated||||0.05
71920211|NCT02996981|143362060|SUPERIORITY|||||||0.299|||||||Chi-squared|df=1||||||0.299
71920212|NCT01038635|143362068|SUPERIORITY_OR_OTHER||Maximal tolerated dose|75.0|||||TWO_SIDED||||||||Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.|||||
71920213|NCT03018340|143362096|SUPERIORITY||Difference in weighted MMRM LSMs|-1.7|STANDARD_ERROR_OF_MEAN|0.85||0.039|TWO_SIDED|95.0|-3.4|-0.1|||Mixed Models Analysis|||This is the primary statistical comparison for Stage 1 and Stage 2 combined.||-0.1|-3.4|0.0390
71686722|NCT00410072|142890777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|-1.5|17.1|||NC=F|||Analysis at Week 48. The stratified analysis was based on HBeAg strata at randomization.||17.1|-1.5|
71920214|NCT03018340|143362096|SUPERIORITY||Difference in MMRM LSMs|-4.0|STANDARD_ERROR_OF_MEAN|1.09||0.0003|TWO_SIDED|95.0|-6.1|-1.9|||Mixed Models Analysis|||||-1.9|-6.1|0.0003
71686723|NCT00410072|142890777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|||||TWO_SIDED|95.0|-0.2|17.3|||NC=F|||Analysis at Week 96. The stratified analysis was based on HBeAg strata at randomization.||17.3|-0.2|
71920215|NCT03018340|143362096|SUPERIORITY||Difference in MMRM LSMs|0.5|STANDARD_ERROR_OF_MEAN|1.3||0.694|TWO_SIDED|95.0|-2.1|3.1|||Mixed Models Analysis|||||3.1|-2.1|0.6940
71920216|NCT00203294|143362158|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.|Fisher Exact|||Fisher's exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||||<0.01
71920217|NCT00203294|143362158|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||Fisher's exact test was used to compare nominal variables between groups.||||<0.01
71920218|NCT00247962|143362162|SUPERIORITY_OR_OTHER||Risk Difference (RD)|22.99|||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71920219|NCT00247962|143362163|SUPERIORITY_OR_OTHER|||||||0.719|||||||ANCOVA|||baseline||||0.719
71920220|NCT00247962|143362163|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||week 16||||0.010
71920221|NCT02607735|143362170|SUPERIORITY|The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|||||<|0.001|||||||2-sided exact 1-sample binomial test|||||||<0.001
71920222|NCT04111185|143362181|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71686724|NCT00410072|142890779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.4|||||TWO_SIDED|95.0|-18.8|-2.0|||NC+F|||Analysis at Week 48. The stratified analysis is based on HBeAg strata at randomization.||-2.0|-18.8|
71686725|NCT00410072|142890779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.8|||||TWO_SIDED|95.0|-21.5|-4.1|||NC=F|||Analysis at Week 96. The stratified analysis is based on HBeAg strata at randomization.||-4.1|-21.5|
71686726|NCT00410072|142890780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||||TWO_SIDED|95.0|-15.9|4.2|||NC=F|||Analysis at Week 48||4.2|-15.9|
71879657|NCT01431274|143278899|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.025||0.9369|TWO_SIDED|95.0|-0.051|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.047|-0.051|0.9369
71879658|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.168|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.119|0.217||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.217|0.119|<0.0001
71879659|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.154|0.056|<0.0001
71686727|NCT00410072|142890780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|95.0|-20.6|2.3|||NC=F|||Analysis at Week 96||2.3|-20.6|
71686728|NCT00410072|142890781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.1|||||TWO_SIDED|95.0|-13.8|5.6|||NC=F|||Analysis at Week 48||5.6|-13.8|
71686729|NCT00410072|142890781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.8|||||TWO_SIDED|95.0|-21.5|-0.1|||NC=F|||Analysis at Week 96||-0.1|-21.5|
71686730|NCT00410072|142890782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||||TWO_SIDED|95.0|-5.3|1.9|||NC=F|||Analysis at Week 48||1.9|-5.3|
71686731|NCT00410072|142890782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|||||TWO_SIDED|95.0|-3.9|6.1|||NC=F|||Analysis at Week 96||6.1|-3.9|
71686732|NCT00410072|142890783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|95.0|-2.2|2.0|||NC=F|||Analysis at Week 48||2.0|-2.2|
71686733|NCT00410072|142890783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||NC=F|||Analysis at Week 96||4.9|-2.3|
71920223|NCT00742391|143362189|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71920224|NCT00742391|143362190|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||0.0001
71920225|NCT01981096|143362193|SUPERIORITY|||||||0.011||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.011
71920226|NCT01981096|143362194|SUPERIORITY|||||||0.055||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.||||.055
71920227|NCT01225211|143362199|SUPERIORITY_OR_OTHER||LS Mean difference|-2.679||||0.267|TWO_SIDED|95.0|-7.484|2.125|||ANCOVA|||||2.125|-7.484|0.267
71920228|NCT01225211|143362199|SUPERIORITY_OR_OTHER||LS Mean difference|-9.676|||<|0.001|TWO_SIDED|95.0|-14.801|-4.551|||ANCOVA|||||-4.551|-14.801|<0.001
71920229|NCT01225211|143362200|SUPERIORITY_OR_OTHER||LS Mean difference|-1.306||||0.68|TWO_SIDED|95.0|-7.565|4.953|||ANCOVA|||||4.953|-7.565|0.680
71920230|NCT01225211|143362200|SUPERIORITY_OR_OTHER||LS Mean difference|-2.67||||0.409|TWO_SIDED|95.0|-9.053|3.712|||ANCOVA|||||3.712|-9.053|0.409
71920231|NCT01225211|143362200|SUPERIORITY_OR_OTHER||LS Mean difference|-4.526||||0.161|TWO_SIDED|95.0|-10.888|1.835|||ANCOVA|||||1.835|-10.888|0.161
71920232|NCT01225211|143362200|SUPERIORITY_OR_OTHER||LS Mean difference|-2.867||||0.396|TWO_SIDED|95.0|-9.543|3.81|||ANCOVA|||||3.810|-9.543|0.396
71920233|NCT01225211|143362200|SUPERIORITY_OR_OTHER||LS Mean difference|-3.78||||0.365|TWO_SIDED|95.0|-12.028|4.467|||ANCOVA|||||4.467|-12.028|0.365
71920234|NCT01225211|143362201|SUPERIORITY_OR_OTHER||LS Mean difference|0.6||||0.5978|TWO_SIDED|95.0|-1.66|2.86|||Mixed Model Repeated Measure (MMRM)|||||2.86|-1.66|0.5978
71920235|NCT01241318|143362220|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.88|1.44|||||The chlorhexidine arm is the numerator and dry cord care arm is the denominator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.|||1.44|0.88|
71920236|NCT01241318|143362221|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.12|||||TWO_SIDED|95.0|0.86|1.47|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.47|0.86|
71920237|NCT01241318|143362222|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.47|1.13|||||Generalized estimating equation models adjusting for cluster-randomized design were used.|||1.13|0.47|
71920238|NCT02355665|143362229|SUPERIORITY||Estimated Success Rate Ratio|2.0||||0.021|TWO_SIDED|95.0|1.1|3.66||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.66|1.10|0.021
71922428|NCT03287960|143365322|OTHER|Two-sided confidence interval obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of participants in the population of interest will achieve 10% weight loss.||||||0.0001|||||||Clopper-Pearson method|||||||0.0001
71920239|NCT02355665|143362230|SUPERIORITY||Estimated Success Rate Ratio|3.04||||0.004|TWO_SIDED|95.0|1.39|6.68||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.68|1.39|0.004
71879660|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.103|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.054|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.152|0.054|<0.0001
71879661|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.025||0.0585|TWO_SIDED|95.0|-0.002|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.096|-0.002|0.0585
71879662|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.025||0.1042|TWO_SIDED|95.0|-0.008|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.090|-0.008|0.1042
71879663|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.065|STANDARD_ERROR_OF_MEAN|0.025||0.0097|TWO_SIDED|95.0|0.016|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.114|0.016|0.0097
71879664|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.063|0.161||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.161|0.063|<0.0001
71879665|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.025||0.012|TWO_SIDED|95.0|0.014|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.112|0.014|0.0120
71879666|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.056|STANDARD_ERROR_OF_MEAN|0.025||0.025|TWO_SIDED|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.105|0.007|0.0250
71879667|NCT01431274|143278900|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.007|STANDARD_ERROR_OF_MEAN|0.025||0.7889|TWO_SIDED|95.0|-0.042|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.056|-0.042|0.7889
71879668|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.187|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.138|0.237||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.237|0.138|<0.0001
71879669|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.121|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.170|0.072|<0.0001
71879670|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.103|0.202||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.202|0.103|<0.0001
71879671|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.025||0.0134|TWO_SIDED|95.0|0.013|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.111|0.013|0.0134
71686734|NCT01421147|142890797|SUPERIORITY_OR_OTHER||LS Mean Difference|0.108||||0.055|TWO_SIDED|95.0|-0.002|0.219|||ANCOVA|||||0.219|-0.002|0.055
71686735|NCT01421147|142890798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.205|TWO_SIDED|95.0|-0.23|1.05||P-value is for change at 6 weeks.|ANCOVA|||||1.05|-0.23|0.205
71686736|NCT01421147|142890798|SUPERIORITY_OR_OTHER||LS Mean difference|0.4||||0.32|TWO_SIDED|95.0|-0.4|1.21||P-value is for change at 12 weeks.|ANCOVA|||||1.21|-0.40|0.320
71686737|NCT01421147|142890798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37||||0.373|TWO_SIDED|95.0|-0.46|1.21||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||1.21|-0.46|0.373
71686738|NCT01421147|142890798|SUPERIORITY_OR_OTHER||LS Mean Difference|0.81||||0.131|TWO_SIDED|95.0|-0.25|1.86||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||1.86|-0.25|0.131
71686739|NCT01421147|142890799|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.007||||0.86|TWO_SIDED|95.0|-0.087|0.072||P-value is for change at 6 weeks.|ANCOVA|||||0.072|-0.087|0.860
71920240|NCT02355665|143362231|SUPERIORITY||Estimated Success Rate Ratio|2.87||||0.011|TWO_SIDED|95.0|1.23|6.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.71|1.23|0.011
71922429|NCT03287960|143365323|OTHER|Two-sided confidence interval (CI) obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that at least 5% of patients in the population of interest would achieve 10% weight loss.|||||<|0.0001|||||||Clopper-Pearson method|||||||<0.0001
71686740|NCT01421147|142890799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.113||||0.03|TWO_SIDED|95.0|0.011|0.215||P-value is for change at 12 weeks.|ANCOVA|||||0.215|0.011|0.030
71879672|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.086|STANDARD_ERROR_OF_MEAN|0.025||0.0006|TWO_SIDED|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.136|0.037|0.0006
71879673|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.035|STANDARD_ERROR_OF_MEAN|0.025||0.167|TWO_SIDED|95.0|-0.015|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.084|-0.015|0.1670
71879674|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.097|STANDARD_ERROR_OF_MEAN|0.025||0.0001|TWO_SIDED|95.0|0.048|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.146|0.048|0.0001
71879675|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.025||0.0085|TWO_SIDED|95.0|0.017|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.115|0.017|0.0085
71879676|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0003|TWO_SIDED|95.0|0.041|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.140|0.041|0.0003
71879677|NCT01431274|143278901|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.025||0.3332|TWO_SIDED|95.0|-0.074|0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.025|-0.074|0.3332
71879678|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.153|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.105|0.201||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.201|0.105|<0.0001
71879679|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.024||0.0016|TWO_SIDED|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.125|0.029|0.0016
71879680|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.084|0.18||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.180|0.084|<0.0001
71879681|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.024||0.0926|TWO_SIDED|95.0|-0.007|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.089|-0.007|0.0926
71879682|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.055|STANDARD_ERROR_OF_MEAN|0.024||0.0231|TWO_SIDED|95.0|0.008|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.103|0.008|0.0231
71879683|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.024||0.3802|TWO_SIDED|95.0|-0.026|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.069|-0.026|0.3802
71920241|NCT02355665|143362232|SUPERIORITY||Estimated Success Rate Ratio|1.66||||0.04|TWO_SIDED|95.0|1.02|2.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||2.71|1.02|0.040
71879684|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.062|STANDARD_ERROR_OF_MEAN|0.024||0.0105|TWO_SIDED|95.0|0.015|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.110|0.015|0.0105
71879685|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.025||0.0018|TWO_SIDED|95.0|0.028|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.125|0.028|0.0018
71879686|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.091|STANDARD_ERROR_OF_MEAN|0.025||0.0002|TWO_SIDED|95.0|0.043|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.139|0.043|0.0002
71879687|NCT01431274|143278902|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.014|STANDARD_ERROR_OF_MEAN|0.024||0.5554|TWO_SIDED|95.0|-0.062|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.034|-0.062|0.5554
71879688|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.178|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.127|0.228||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.228|0.127|<0.0001
71879689|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.084|STANDARD_ERROR_OF_MEAN|0.026||0.0011|TWO_SIDED|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.134|0.033|0.0011
71879690|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.142|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.091|0.192||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.192|0.091|<0.0001
71879691|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.041|STANDARD_ERROR_OF_MEAN|0.026||0.1112|TWO_SIDED|95.0|-0.009|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.091|-0.009|0.1112
71879692|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.048|STANDARD_ERROR_OF_MEAN|0.026||0.0632|TWO_SIDED|95.0|-0.003|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.098|-0.003|0.0632
71879693|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.036|STANDARD_ERROR_OF_MEAN|0.026||0.1615|TWO_SIDED|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.086|-0.014|0.1615
71920242|NCT02355665|143362233|SUPERIORITY||Estimated Success Rate Ratio|2.09||||0.023|TWO_SIDED|95.0|1.09|3.98||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||3.98|1.09|0.023
71920243|NCT02355665|143362234|SUPERIORITY||Estimated Success Rate Ratio|2.91||||0.006|TWO_SIDED|95.0|1.32|6.42||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||6.42|1.32|0.006
71920244|NCT02355665|143362235|SUPERIORITY||Estimated Success Rate Ratio|2.66||||0.013|TWO_SIDED|95.0|1.2|5.92||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (\<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.||5.92|1.20|0.013
71920245|NCT02355665|143362236|SUPERIORITY||Estimated Mean Difference|-0.02||||0.847|TWO_SIDED|95.0|-0.64|0.6||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.60|-0.64|0.847
71920246|NCT02355665|143362237|SUPERIORITY||Estimated Mean Difference|-0.1||||0.861|TWO_SIDED|95.0|-0.62|0.42||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.42|-0.62|0.861
71920247|NCT02355665|143362238|SUPERIORITY||Estimated Mean Difference|-0.19||||0.266|TWO_SIDED|95.0|-0.61|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.24|-0.61|0.266
71920248|NCT02355665|143362239|SUPERIORITY||Estimated Mean Difference|0.09||||0.487|TWO_SIDED|95.0|-0.38|0.55||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.||0.55|-0.38|0.487
71920249|NCT02355665|143362240|SUPERIORITY||Estimated Mean Difference|-0.11||||0.433|TWO_SIDED|95.0|-0.65|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.43|-0.65|0.433
71920250|NCT02355665|143362241|SUPERIORITY||Estimated Mean Difference|-0.58||||0.022|TWO_SIDED|95.0|-1.15|-0.01||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||-0.01|-1.15|0.022
71920251|NCT02355665|143362242|SUPERIORITY||Estimated Mean Difference|0.0||||0.665|TWO_SIDED|95.0|-0.5|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.49|-0.50|0.665
71920252|NCT02355665|143362243|SUPERIORITY||Estimated Mean Difference|-0.1||||0.3|TWO_SIDED|95.0|-0.51|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.||0.31|-0.51|0.300
71920253|NCT02355665|143362244|SUPERIORITY||Estimated Mean Difference|-0.17||||0.754|TWO_SIDED|95.0|-0.78|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.43|-0.78|0.754
71920254|NCT02355665|143362245|SUPERIORITY||Estimated Mean Difference|-0.41||||0.116|TWO_SIDED|95.0|-0.89|0.08||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.08|-0.89|0.116
71920255|NCT02355665|143362246|SUPERIORITY||Estimated Mean Difference|-0.14||||0.392|TWO_SIDED|95.0|-0.47|0.2||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.20|-0.47|0.392
71920256|NCT02355665|143362247|SUPERIORITY||Estimated Mean Difference|-0.23||||0.179|TWO_SIDED|95.0|-0.59|0.13||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.||0.13|-0.59|0.179
71922430|NCT03287960|143365324|OTHER|Model based summary statistics from longitudinal mixed analysis of variance (ANOVA) model with fixed effect for visit, baseline body weight and random effect for participant, one sided p-value from model.|Least Squares Mean|-12.37|||<|0.0001|TWO_SIDED|90.0|-15.08|-9.66|||ANOVA|Longitudinal mixed ANOVA||||-9.66|-15.08|<.0001
71686741|NCT01421147|142890799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.098||||0.08|TWO_SIDED|95.0|-0.012|0.208||P-value is for change at 24 weeks.|ANCOVA|||||0.208|-0.012|0.080
71686742|NCT01421147|142890799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.314|TWO_SIDED|95.0|-0.057|0.177||P-value is for change at 36 weeks.|ANCOVA|||||0.177|-0.057|0.314
71686743|NCT01421147|142890799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.004||||0.948|TWO_SIDED|95.0|-0.119|0.127||P-value is for change at 52 weeks.|ANCOVA|||||0.127|-0.119|0.948
71920257|NCT02355665|143362248|SUPERIORITY||Estimated Mean Difference|0.01||||0.925|TWO_SIDED|95.0|-0.44|0.47||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.47|-0.44|0.925
71920258|NCT02355665|143362249|SUPERIORITY||Estimated Mean Difference|-0.21||||0.325|TWO_SIDED|95.0|-0.66|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.24|-0.66|0.325
71920259|NCT02355665|143362250|SUPERIORITY||Estimated Mean Difference|0.13||||0.891|TWO_SIDED|95.0|-0.24|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.51|-0.24|0.891
71920260|NCT02355665|143362251|SUPERIORITY||Estimated Mean Difference|-0.11||||0.721|TWO_SIDED|95.0|-0.48|0.25||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.||0.25|-0.48|0.721
71920261|NCT02355665|143362252|SUPERIORITY||Estimated Mean Difference|-0.03||||0.608|TWO_SIDED|95.0|-0.54|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.49|-0.54|0.608
71920262|NCT02355665|143362253|SUPERIORITY||Estimated Mean Difference|-0.63||||0.014|TWO_SIDED|95.0|-1.16|-0.09||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||-0.09|-1.16|0.014
71920263|NCT02355665|143362254|SUPERIORITY||Estimated Mean Difference|0.04||||0.9|TWO_SIDED|95.0|-0.3|0.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.38|-0.30|0.900
71920264|NCT02355665|143362255|SUPERIORITY||Estimated Mean Difference|-0.06||||0.731|TWO_SIDED|95.0|-0.44|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.||0.31|-0.44|0.731
71920265|NCT02355665|143362256|SUPERIORITY||Estimated Mean Difference|0.04||||0.635|TWO_SIDED|95.0|-0.28|0.36||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.36|-0.28|0.635
71920266|NCT02355665|143362257|SUPERIORITY||Estimated Mean Difference|-0.05||||0.273|TWO_SIDED|95.0|-0.42|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.42|0.273
71920267|NCT02355665|143362258|SUPERIORITY||Estimated Mean Difference|-0.06||||0.879|TWO_SIDED|95.0|-0.4|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.28|-0.40|0.879
71920268|NCT02355665|143362259|SUPERIORITY||Estimated Mean Difference|0.02||||0.823|TWO_SIDED|95.0|-0.28|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.||0.32|-0.28|0.823
71686744|NCT01421147|142890799|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.737|TWO_SIDED|95.0|-0.099|0.14||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.140|-0.099|0.737
71686745|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.18||||0.489|TWO_SIDED|95.0|-0.33|0.69||P-value is for Baseline-AM Pre-Meal.|ANCOVA|||||0.69|-0.33|0.489
71686746|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.066|TWO_SIDED|95.0|-1.0|0.03||P-value is for Baseline-AM 2 hrs PP.|ANCOVA|||||0.03|-1.00|0.066
71686747|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28||||0.209|TWO_SIDED|95.0|-0.71|0.16||P-value is for Baseline-MD Pre-Meal.|ANCOVA|||||0.16|-0.71|0.209
71686748|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31||||0.232|TWO_SIDED|95.0|-0.2|0.82||P-value is for Baseline-MD 2 hrs PP.|ANCOVA|||||0.82|-0.20|0.232
71686749|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05||||0.856|TWO_SIDED|95.0|-0.49|0.58||P-value is for Baseline-EV Pre-Meal.|ANCOVA|||||0.58|-0.49|0.856
71686750|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.11||||0.693|TWO_SIDED|95.0|-0.66|0.44||P-value is for Baseline-Bed Time.|ANCOVA|||||0.44|-0.66|0.693
71686751|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.7|TWO_SIDED|95.0|-0.61|0.41||P-value is for Baseline-0300 hrs.|ANCOVA|||||0.41|-0.61|0.700
71686752|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.399|TWO_SIDED|95.0|-0.23|0.58||P-value is for Endpoint, up to 24 wk-AM Pre-Meal.|ANCOVA|||||0.58|-0.23|0.399
71686753|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.248|TWO_SIDED|95.0|-0.18|0.68||P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.|ANCOVA|||||0.68|-0.18|0.248
71686754|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.883|TWO_SIDED|95.0|-0.44|0.38||P-value is for Endpoint, up to 24 wk-MD Pre-Meal.|ANCOVA|||||0.38|-0.44|0.883
71686755|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.687|TWO_SIDED|95.0|-0.34|0.52||P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.|ANCOVA|||||0.52|-0.34|0.687
71686756|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.364|TWO_SIDED|95.0|-0.24|0.65||P-value is for Endpoint, up to 24 wk-EV Pre-Meal.|ANCOVA|||||0.65|-0.24|0.364
71920269|NCT02355665|143362260|SUPERIORITY||Estimated Mean Difference|0.0||||0.804|TWO_SIDED|95.0|-0.4|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.40|-0.40|0.804
71686757|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.03|TWO_SIDED|95.0|-0.95|-0.05||P-value is for Endpoint, up to 24 wk- Bed Time.|ANCOVA|||||-0.05|-0.95|0.030
71686758|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45||||0.033|TWO_SIDED|95.0|-0.86|-0.04||P-value is for Endpoint, up to 24 wk-0300 hrs.|ANCOVA|||||-0.04|-0.86|0.033
71686759|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.23|TWO_SIDED|95.0|-0.68|0.16||P-value is for Endpoint, up to 52 wk-AM Pre-Meal.|ANCOVA|||||0.16|-0.68|0.230
71686760|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32||||0.148|TWO_SIDED|95.0|-0.76|0.11||P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.|ANCOVA|||||0.11|-0.76|0.148
71686761|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.03||||0.866|TWO_SIDED|95.0|-0.43|0.36||P-value is for Endpoint, up to 52 wk-MD Pre-Meal.|ANCOVA|||||0.36|-0.43|0.866
71686762|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13||||0.545|TWO_SIDED|95.0|-0.56|0.3||P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.|ANCOVA|||||0.30|-0.56|0.545
71920270|NCT02355665|143362261|SUPERIORITY||Estimated Mean Difference|0.13||||0.438|TWO_SIDED|95.0|-0.3|0.57||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.57|-0.30|0.438
71686763|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01||||0.955|TWO_SIDED|95.0|-0.44|0.42||P-value is for Endpoint, up to 52 wk-EV Pre-Meal.|ANCOVA|||||0.42|-0.44|0.955
71686764|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48||||0.031|TWO_SIDED|95.0|-0.92|-0.04||P-value is for Endpoint, up to 52 wk-Bed Time.|ANCOVA|||||-0.04|-0.92|0.031
71686765|NCT01421147|142890800|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21||||0.355|TWO_SIDED|95.0|-0.65|0.23||P-vale is for Endpoint, up to 52 wk-0300 hrs.|ANCOVA|||||0.23|-0.65|0.355
71686766|NCT01421147|142890801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17||||0.32|TWO_SIDED|95.0|-0.52|0.17||P-value is for Baseline.|ANCOVA|||||0.17|-0.52|0.320
71686767|NCT01421147|142890801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.781|TWO_SIDED|95.0|-0.33|0.25||P-value is for Endpoint, up to 24 weeks.|ANCOVA|||||0.25|-0.33|0.781
71686768|NCT01421147|142890801|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.26||||0.06|TWO_SIDED|95.0|-0.53|0.01||P-value is for Endpoint, up to 52 weeks.|ANCOVA|||||0.01|-0.53|0.060
71686769|NCT01421147|142890802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||P-value is for change at 6 weeks.|ANCOVA|||||0.29|-0.23|0.823
71686770|NCT01421147|142890802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11||||0.541|TWO_SIDED|95.0|-0.25|0.47||P-value is for change at 12 weeks.|ANCOVA|||||0.47|-0.25|0.541
71686771|NCT01421147|142890802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.17||||0.435|TWO_SIDED|95.0|-0.25|0.59||P-value is for change at 18 weeks.|ANCOVA|||||0.59|-0.25|0.435
71686772|NCT01421147|142890802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.24||||0.32|TWO_SIDED|95.0|-0.23|0.71||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA|||||0.71|-0.23|0.320
71686773|NCT01421147|142890802|SUPERIORITY_OR_OTHER||LS Mean Difference|0.34||||0.253|TWO_SIDED|95.0|-0.25|0.93||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA|||||0.93|-0.25|0.253
71686774|NCT01421147|142890803|SUPERIORITY_OR_OTHER||LS Mean Difference|0.64||||0.401|TWO_SIDED|95.0|-0.86|2.15||P-value is for Baseline-Behavior TS.|ANCOVA|||||2.15|-0.86|0.401
71686775|NCT01421147|142890803|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.778|TWO_SIDED|95.0|-1.16|1.55||P-value is for 24 weeks-Behavior TS|ANCOVA|||||1.55|-1.16|0.778
71686776|NCT01421147|142890803|SUPERIORITY_OR_OTHER||LS Mean Difference|0.16||||0.804|TWO_SIDED|95.0|-1.12|1.45||P-value is for Endpoint, up to 52 weeks-Behavior TS.|ANCOVA|||||1.45|-1.12|0.804
71686777|NCT01421147|142890803|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21||||0.304||95.0|-1.1|3.51||P-value is for Baseline-Worry TS.|ANCOVA|||||3.51|-1.10|0.304
71686778|NCT01421147|142890803|SUPERIORITY_OR_OTHER||LS Mean Difference|1.12||||0.323|TWO_SIDED|95.0|-1.1|3.34||P-value is for 24 weeks-Worry TS.|ANCOVA|||||3.34|-1.10|0.323
71686779|NCT01421147|142890803|SUPERIORITY_OR_OTHER||LS Mean Difference|0.25||||0.824||95.0|-1.92|2.41||P-value is for Endpoint, up to 52 weeks-Worry TS.|ANCOVA|||||2.41|-1.92|0.824
71686780|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.77||||0.681|TWO_SIDED|95.0|-4.42|2.89||P-value is for IR-Baseline.|ANCOVA|||||2.89|-4.42|0.681
71686781|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.56||||0.744|TWO_SIDED|95.0|-2.79|3.9||P-value is for IR-24 weeks.|ANCOVA|||||3.90|-2.79|0.744
71686782|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.94||||0.582|TWO_SIDED|95.0|-4.29|2.41||P-value is for IR-Endpoint, up to 52 weeks.|ANCOVA|||||2.41|-4.29|0.582
71686783|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.82||||0.694|TWO_SIDED|95.0|-3.26|4.89||P-value is for LF-Baseline.|ANCOVA|||||4.89|-3.26|0.694
71686784|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.84||||0.673|TWO_SIDED|95.0|-3.08|4.77||P-value is for LF-24 weeks.|ANCOVA|||||4.77|-3.08|0.673
71686785|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.91||||0.645|TWO_SIDED|95.0|-4.79|2.97||P-value is for LF-Endpoint, up to 52 weeks.|ANCOVA|||||2.97|-4.79|0.645
71686786|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.961|TWO_SIDED|95.0|-3.62|3.81||P-value is for GC-Baseline.|ANCOVA|||||3.81|-3.62|0.961
71686787|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|1.25||||0.463|TWO_SIDED|95.0|-2.1|4.61||P-value is for GC-24 weeks.|ANCOVA|||||4.61|-2.10|0.463
71686788|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.91||||0.609|TWO_SIDED|95.0|-2.59|4.41||P-value is for GC-Endpoint, up to 52 weeks.|ANCOVA|||||4.41|-2.59|0.609
71686789|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.61||||0.708|TWO_SIDED|95.0|-3.81|2.59||P-value is for HC-Baseline.|ANCOVA|||||2.59|-3.81|0.708
71686790|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.03||||0.51|TWO_SIDED|95.0|-4.09|2.03||P-value is for HC-24 weeks.|ANCOVA|||||2.03|-4.09|0.510
71686791|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.26||||0.422|TWO_SIDED|95.0|-4.34|1.82||P-value is for HC-Endpoint, up to 52 weeks.|ANCOVA|||||1.82|-4.34|0.422
71686792|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.53||||0.367|TWO_SIDED|95.0|-4.85|1.8||P-value is for IDD-Baseline.|ANCOVA|||||1.80|-4.85|0.367
71686793|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.41||||0.786|TWO_SIDED|95.0|-2.54|3.35||P-value is for IDD-24 weeks.|ANCOVA|||||3.35|-2.54|0.786
71686794|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29||||0.845|TWO_SIDED|95.0|-3.16|2.59||P-value is for IDD-Endpoint, up to 52 weeks.|ANCOVA|||||2.59|-3.16|0.845
71686795|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.59||||0.676|TWO_SIDED|95.0|-3.36|2.18||P-value is for ITSQ Total-Baseline.|ANCOVA|||||2.18|-3.36|0.676
71686796|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23||||0.862|TWO_SIDED|95.0|-2.33|2.78||P-value is for ITSQ Total-24 weeks.|ANCOVA|||||2.78|-2.33|0.862
71686797|NCT01421147|142890804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54||||0.685|TWO_SIDED|95.0|-3.15|2.07||P-value is for ITSQ Total-Endpoint, up to 52 weeks.|ANCOVA|||||2.07|-3.15|0.685
71686798|NCT01421147|142890805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.014||||0.235|TWO_SIDED|95.0|-0.009|0.036||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||0.036|-0.009|0.235
71686799|NCT01421147|142890805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.006||||0.726|TWO_SIDED|95.0|-0.026|0.038||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||0.038|-0.026|0.726
71686800|NCT01421147|142890805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.019||||0.377|TWO_SIDED|95.0|-0.023|0.062||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||0.062|-0.023|0.377
71879694|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.077|STANDARD_ERROR_OF_MEAN|0.026||0.0027|TWO_SIDED|95.0|0.027|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.127|0.027|0.0027
71879695|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.026||0.0003|TWO_SIDED|95.0|0.044|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.144|0.044|0.0003
71879696|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.101|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.05|0.151||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.151|0.050|<0.0001
71879697|NCT01431274|143278903|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.026||0.7925|TWO_SIDED|95.0|-0.057|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.044|-0.057|0.7925
71879698|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.118|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.162|0.074|<0.0001
71879699|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.123|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.169|0.077|<0.0001
71879700|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.071|STANDARD_ERROR_OF_MEAN|0.022||0.0012|TWO_SIDED|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.114|0.028|0.0012
71879701|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.137|0.050|<0.0001
71879702|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.076|STANDARD_ERROR_OF_MEAN|0.023||0.001|TWO_SIDED|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.121|0.031|0.0010
71879703|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.023||0.0384|TWO_SIDED|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.092|0.003|0.0384
71879704|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.141|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.185|0.097|<0.0001
71879705|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.004|STANDARD_ERROR_OF_MEAN|0.023||0.8428|TWO_SIDED|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.040|-0.049|0.8428
71920271|NCT02355665|143362262|SUPERIORITY||Estimated Mean Difference|-0.08||||0.517|TWO_SIDED|95.0|-0.44|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||0.28|-0.44|0.517
71879706|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.022||0.3048|TWO_SIDED|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.020|-0.065|0.3048
71920272|NCT02355665|143362263|SUPERIORITY||Estimated Mean Difference|-0.42||||0.027|TWO_SIDED|95.0|-0.77|-0.06||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.||-0.06|-0.77|0.027
71686801|NCT01421147|142890805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.018||||0.159|TWO_SIDED|95.0|-0.007|0.042||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||0.042|-0.007|0.159
71686802|NCT01421147|142890805|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.001||||0.957|TWO_SIDED|95.0|-0.034|0.032||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||0.032|-0.034|0.957
71686803|NCT01421147|142890805|SUPERIORITY_OR_OTHER||LS Mean Difference|0.017||||0.45|TWO_SIDED|95.0|-0.028|0.062||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||0.062|-0.028|0.450
71686804|NCT01421147|142890806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.724||||0.096|TWO_SIDED|95.0|-0.308|3.755||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA|||||3.755|-0.308|0.096
71686805|NCT01421147|142890806|SUPERIORITY_OR_OTHER||LS Mean Difference|1.267||||0.374|TWO_SIDED|95.0|-1.531|4.065||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA|||||4.065|-1.531|0.374
71879707|NCT01431274|143278904|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.018|STANDARD_ERROR_OF_MEAN|0.023||0.4311|TWO_SIDED|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.063|-0.027|0.4311
71879708|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.098|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.139|0.057|<0.0001
71879709|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.106|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.149|0.063|<0.0001
71879710|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.051|STANDARD_ERROR_OF_MEAN|0.021||0.0136|TWO_SIDED|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.091|0.010|0.0136
71879711|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.075|STANDARD_ERROR_OF_MEAN|0.021||0.0003|TWO_SIDED|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.116|0.035|0.0003
71879712|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.059|STANDARD_ERROR_OF_MEAN|0.022||0.0065|TWO_SIDED|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.101|0.016|0.0065
71920273|NCT02355665|143362264|SUPERIORITY||Estimated Mean Difference|-0.3||||0.105|TWO_SIDED|95.0|-0.93|0.33||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.33|-0.93|0.105
71920274|NCT02355665|143362265|SUPERIORITY||Estimated Mean Difference|-0.04||||0.604|TWO_SIDED|95.0|-0.6|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.51|-0.60|0.604
71920275|NCT02355665|143362266|SUPERIORITY||Estimated Mean Difference|-0.35||||0.194|TWO_SIDED|95.0|-0.93|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.24|-0.93|0.194
71920276|NCT02355665|143362267|SUPERIORITY||Estimated Mean Difference|-0.11||||0.502|TWO_SIDED|95.0|-0.62|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.||0.40|-0.62|0.502
71920277|NCT02355665|143362268|SUPERIORITY||Estimated Mean Difference|-0.56||||0.483|TWO_SIDED|95.0|-2.84|1.73||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.73|-2.84|0.483
71920278|NCT02355665|143362269|SUPERIORITY||Estimated Mean Difference|-1.79||||0.102|TWO_SIDED|95.0|-4.24|0.67||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.67|-4.24|0.102
71686806|NCT01421147|142890806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.964||||0.151|TWO_SIDED|95.0|-1.081|7.01||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA|||||7.010|-1.081|0.151
71686807|NCT01421147|142890806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.059||||0.072|TWO_SIDED|95.0|-0.187|4.305||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA|||||4.305|-0.187|0.072
71879713|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.047|STANDARD_ERROR_OF_MEAN|0.021||0.0277|TWO_SIDED|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.089|0.005|0.0277
71879714|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.122|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.164|0.081|<0.0001
71879715|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.021||0.7116|TWO_SIDED|95.0|-0.049|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.034|-0.049|0.7116
71922431|NCT03287960|143365325|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline daily hunger score and random effect for participant, one sided p-value from model.|Least Squares Mean|-42.69|||<|0.0001|TWO_SIDED|90.0|-56.35|-29.02|||ANOVA|Longitudinal mixed analysis of variance (ANOVA) model||||-29.02|-56.35|<.0001
71922432|NCT03287960|143365326|OTHER|Two-sided CI obtained using Clopper-Pearson method and one-sided p-value obtained from exact binomial test, testing that ≥5 % of participants in the population of interest would achieve ≥25 % improvement in daily hunger score.|||||<|0.0001|||||||Clopper-Pearson method|||||||<.0001
71922433|NCT03287960|143365327|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for visit, baseline waist circumference and random effect for participant, one sided p-value from model.|Least Squares Mean|-8.9||||0.0031|TWO_SIDED|90.0|-14.1|-3.61|||ANOVA|Longitudinal mixed ANOVA||||-3.61|-14.10|0.0031
71922434|NCT03287960|143365330|OTHER|Model based summary statistics from longitudinal mixed analysis of variance model with fixed effect for week, baseline BMI and random effect for participant, one sided p-value from model.|Least Squares Mean|-14.0|||<|0.0001|TWO_SIDED|90.0|-16.8|-11.2|||ANOVA|Longitudinal mixed ANOVA model||||-11.20|-16.80|<.0001
71686808|NCT01421147|142890806|SUPERIORITY_OR_OTHER||LS Mean Difference|0.702||||0.617|TWO_SIDED|95.0|-2.058|3.462||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA|||||3.462|-2.058|0.617
71686809|NCT01421147|142890806|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8||||0.188|TWO_SIDED|95.0|-1.37|6.971||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA|||||6.971|-1.370|0.188
71686810|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.015||||||P-value is for HbA1c- at Baseline \<7.0 %.|Fisher Exact|||||||0.015
71686811|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for HbA1c- at Baseline ≤6.5%.|Fisher Exact|||||||0.606
71686812|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.012||||||P-value is for HbA1c- at 6 weeks \<7.0%.|Fisher Exact|||||||0.012
71686813|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.053||||||P-value is for HbA1c- at 6 weeks ≤6.5%.|Fisher Exact|||||||0.053
71686814|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.398||||||P-value is for HbA1c- at 12 weeks \<7.0%.|Fisher Exact|||||||0.398
71686815|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.17||||||P-value is for HbA1c- at 12 weeks ≤6.5%.|Fisher Exact|||||||0.170
71686816|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.926||||||P-value is for HbA1c- at 24 weeks \<7.0%.|Fisher Exact|||||||0.926
71686817|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.824||||||P-value is for HbA1c- at 24 weeks ≤6.5%.|Fisher Exact|||||||0.824
71686818|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.385||||||P-value is for HbA1c- at 36 weeks \<7.0%.|Fisher Exact|||||||0.385
71686819|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.408||||||P-value is for HbA1c- at 36 weeks ≤6.5%.|Fisher Exact|||||||0.408
71686820|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.551||||||P-value is for HbA1c- at 52 weeks \<7.0%.|Fisher Exact|||||||0.551
71686821|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.9||||||P-value is for HbA1c- at 52 weeks ≤6.5%.|Fisher Exact|||||||0.900
71686822|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.646||||||P-value is for HbA1c- Endpoint, up to 24 weeks \<7.0%.|Fisher Exact|||||||0.646
71879716|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.024|STANDARD_ERROR_OF_MEAN|0.02||0.2332|TWO_SIDED|95.0|-0.065|0.016||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.016|-0.065|0.2332
71879717|NCT01431274|143278905|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.017|STANDARD_ERROR_OF_MEAN|0.021||0.4374|TWO_SIDED|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.059|-0.025|0.4374
71879718|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.161|STANDARD_ERROR_OF_MEAN|0.043||0.0002|TWO_SIDED|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.244|0.077|0.0002
71879719|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.14|STANDARD_ERROR_OF_MEAN|0.045||0.0017|TWO_SIDED|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.228|0.053|0.0017
71879720|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.128|STANDARD_ERROR_OF_MEAN|0.042||0.0022|TWO_SIDED|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.210|0.046|0.0022
71879721|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.176|STANDARD_ERROR_OF_MEAN|0.042|<|0.0001|TWO_SIDED|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.259|0.093|<0.0001
71879722|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.108|STANDARD_ERROR_OF_MEAN|0.044||0.0141|TWO_SIDED|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.194|0.022|0.0141
71879723|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.043||0.4581|TWO_SIDED|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.118|-0.053|0.4581
71879724|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.208|STANDARD_ERROR_OF_MEAN|0.043|<|0.0001|TWO_SIDED|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.293|0.124|<0.0001
71879725|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.021|STANDARD_ERROR_OF_MEAN|0.043||0.6335|TWO_SIDED|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.105|-0.064|0.6335
71686823|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.|Fisher Exact|||||||0.661
71686824|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.209||||||P-value is for HbA1c- Endpoint, up to 52 weeks \<7.0%.|Fisher Exact|||||||0.209
71879726|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.047|STANDARD_ERROR_OF_MEAN|0.041||0.253|TWO_SIDED|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.034|-0.129|0.2530
71879727|NCT01431274|143278906|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.068|STANDARD_ERROR_OF_MEAN|0.043||0.1188|TWO_SIDED|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.153|-0.017|0.1188
71879728|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.041||0.0008|TWO_SIDED|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).|||0.217|0.057|0.0008
71879729|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.126|STANDARD_ERROR_OF_MEAN|0.043||0.0032|TWO_SIDED|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||0.209|0.042|0.0032
71879730|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.04||0.0085|TWO_SIDED|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).|||0.183|0.027|0.0085
71879731|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.156|STANDARD_ERROR_OF_MEAN|0.04||0.0001|TWO_SIDED|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).|||0.235|0.077|0.0001
71922435|NCT00612573|143365341|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.75|STANDARD_DEVIATION|0.85||0.779|TWO_SIDED|95.0|-14.8|10.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||10.3|-14.8|0.779
71922436|NCT00612573|143365341|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.69|STANDARD_DEVIATION|0.9||0.983|TWO_SIDED|95.0|-13.7|11.7|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||11.7|-13.7|0.983
71922437|NCT00612573|143365341|SUPERIORITY_OR_OTHER||Mean Change from Baseline|-0.92|STANDARD_DEVIATION|0.97||0.087|TWO_SIDED|95.0|-1.5|27.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||27.3|-1.5|0.087
71922438|NCT00612573|143365342|SUPERIORITY_OR_OTHER|||||||0.807||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.807
71922439|NCT00612573|143365342|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.075
71686825|NCT01421147|142890807|SUPERIORITY_OR_OTHER|||||||0.54||||||P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.|Fisher Exact|||||||0.540
71686826|NCT01421147|142890808|SUPERIORITY_OR_OTHER|||||||0.703||||||P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.|Fisher Exact|||||||0.703
71686827|NCT01421147|142890808|SUPERIORITY_OR_OTHER|||||||0.495||||||P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.|Fisher Exact|||||||0.495
71686828|NCT01421147|142890808|SUPERIORITY_OR_OTHER|||||||0.174||||||P-value is for Severe Events-24 wk.|Fisher Exact|||||||0.174
71686829|NCT01421147|142890808|SUPERIORITY_OR_OTHER|||||||0.828||||||P-value is for Severe Events-52 wk.|Fisher Exact|||||||0.828
71879732|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.094|STANDARD_ERROR_OF_MEAN|0.042||0.0255|TWO_SIDED|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).|||0.176|0.011|0.0255
71879733|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.032|STANDARD_ERROR_OF_MEAN|0.041||0.4393|TWO_SIDED|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).|||0.113|-0.049|0.4393
71879734|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.188|STANDARD_ERROR_OF_MEAN|0.041|<|0.0001|TWO_SIDED|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).|||0.269|0.108|<0.0001
71879735|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.012|STANDARD_ERROR_OF_MEAN|0.041||0.7784|TWO_SIDED|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).|||0.092|-0.069|0.7784
71879736|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.039||0.1965|TWO_SIDED|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).|||0.026|-0.129|0.1965
71879737|NCT01431274|143278907|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.063|STANDARD_ERROR_OF_MEAN|0.041||0.1315|TWO_SIDED|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).|||0.144|-0.019|0.1315
71879738|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.141|STANDARD_ERROR_OF_MEAN|0.56||0.0001|TWO_SIDED|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-1.043|-3.239|0.0001
71879739|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.131|STANDARD_ERROR_OF_MEAN|0.56||0.0435|TWO_SIDED|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).|||-0.033|-2.230|0.0435
71879740|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.528|STANDARD_ERROR_OF_MEAN|0.559||0.0063|TWO_SIDED|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.432|-2.623|0.0063
71879741|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.517|STANDARD_ERROR_OF_MEAN|0.558||0.3545|TWO_SIDED|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.577|-1.611|0.3545
71879742|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.518|STANDARD_ERROR_OF_MEAN|0.559||0.3542|TWO_SIDED|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.578|-1.614|0.3542
71879743|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.613|STANDARD_ERROR_OF_MEAN|0.556||0.2697|TWO_SIDED|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.476|-1.702|0.2697
71879744|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.559||0.0434|TWO_SIDED|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||-0.033|-2.227|0.0434
71920279|NCT02355665|143362270|SUPERIORITY||Estimated Mean Difference|-0.45||||0.532|TWO_SIDED|95.0|-2.27|1.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||1.38|-2.27|0.532
71920280|NCT02355665|143362271|SUPERIORITY||Estimated Mean Difference|-1.01||||0.354|TWO_SIDED|95.0|-2.93|0.91||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.||0.91|-2.93|0.354
71686830|NCT01421147|142890808|SUPERIORITY_OR_OTHER|||||||0.661||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Fisher Exact|||||||0.661
71686831|NCT01421147|142890808|SUPERIORITY_OR_OTHER|||||||0.606||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Fisher Exact|||||||0.606
71922440|NCT00612573|143365342|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.039
71922441|NCT00612573|143365343|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.212
71922442|NCT00612573|143365343|SUPERIORITY_OR_OTHER|||||||0.505||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.505
71686832|NCT01421147|142890809|SUPERIORITY_OR_OTHER|||||||0.717||||||P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.717
71920281|NCT02355665|143362440|SUPERIORITY||Least Squares Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|1.679||0.558|TWO_SIDED|95.0|-2.42|4.41||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||4.41|-2.42|0.558
71920282|NCT02355665|143362441|SUPERIORITY||Least Squares Mean Difference|3.04|STANDARD_ERROR_OF_MEAN|3.409||0.383|TWO_SIDED|95.0|-4.03|10.11||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||10.11|-4.03|0.383
71920283|NCT02355665|143362442|SUPERIORITY||Least Squares Mean Difference|7.13|STANDARD_ERROR_OF_MEAN|4.573||0.138|TWO_SIDED|95.0|-2.56|16.83||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.||16.83|-2.56|0.138
71686833|NCT01421147|142890809|SUPERIORITY_OR_OTHER|||||||0.163||||||P-value is for Severe Events-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.163
71686834|NCT01421147|142890809|SUPERIORITY_OR_OTHER|||||||0.669||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Wilcoxon (Mann-Whitney)|||||||0.669
71922443|NCT00612573|143365343|SUPERIORITY_OR_OTHER|||||||0.399||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.399
71922444|NCT00612573|143365344|SUPERIORITY_OR_OTHER|||||||0.276||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.276
71922445|NCT00612573|143365344|SUPERIORITY_OR_OTHER|||||||0.231||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.231
71922446|NCT00612573|143365344|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||Cochran-Mantel-Haenszel|Stratified by Investigational Site||||||0.081
71686835|NCT01421147|142890809|SUPERIORITY_OR_OTHER|||||||0.738||||||P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.738
71686836|NCT01421147|142890809|SUPERIORITY_OR_OTHER|||||||0.826||||||P-value is for Severe Events-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.826
71922447|NCT01425268|143365355|NON_INFERIORITY|Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.|margin of non-inferiority|-7.3|||||ONE_SIDED|95.0|-7.3241||||||The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of \> -10%.|The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \< πTreatment - πControl).|||-7.3241|
71922448|NCT01425268|143365356|SUPERIORITY||||||<|0.0001|||||||Kaplan-Meier Log Rank test|Subjects not completing tissue expansion are censored in the analysis||||||<0.0001
71922449|NCT02257970|143365359|EQUIVALENCE|The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||<|0.0001|||||||t-test, 2 sided|paired t-test||For the analysis, the 4-month post-minus-pre change in this score for ketoprofen was compared.||||<0.0001
71922450|NCT02257970|143365360|EQUIVALENCE|Pre-to-post comparison: the likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.6|||||||t-test, 2 sided|Paired t-test||||||=0.6
71922451|NCT02257970|143365360|EQUIVALENCE|Pre-to-Post comparison: The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P\<0.05|||||=|0.01|||||||t-test, 2 sided|paired t-test||||||=0.01
71922452|NCT00883896|143365377|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-5.9||||0.558|TWO_SIDED|95.0|-25.0|13.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided Cochran-Mantel-Haenszel (CMH) test stratified by anti-tumor necrosis factor (anti-TNF) prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.3|-25.0|0.558
71922453|NCT00883896|143365377|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.4||||0.251|TWO_SIDED|95.0|-30.1|7.3|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-30.1|0.251
71922454|NCT00883896|143365377|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.7||||0.707|TWO_SIDED|95.0|-21.7|14.4|||Cochran-Mantel-Haenszel|||P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.4|-21.7|0.707
71922455|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.991|TWO_SIDED|95.0|-14.8|14.7|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.7|-14.8|0.991
71922456|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-4.8||||0.518|TWO_SIDED|95.0|-18.4|8.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-18.4|0.518
71920284|NCT01058356|143362448|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|STANDARD_ERROR_OF_MEAN|0.4|<|0.05|TWO_SIDED|95.0|0.17|4.15|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||4.15|0.17|<0.05
71920285|NCT01058356|143362449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85|STANDARD_ERROR_OF_MEAN|0.27|<|0.05|TWO_SIDED|95.0|0.18|1.55|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"||1.55|0.18|<0.05
71920286|NCT02140762|143362456|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|67.0|||<|0.0001|TWO_SIDED|95.0|65.0|69.0|||Generalized Linear Model||VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||69|65|<0.0001
71920287|NCT02140762|143362456|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|4.6|||||TWO_SIDED||||||Generalized Linear Model|||vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71920288|NCT02140762|143362456|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|12.7|||||TWO_SIDED||||||generalized linear model.|||Vaccine effectiveness \<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71920289|NCT02140762|143362456|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|18.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71920290|NCT02140762|143362456|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|59.1|||||TWO_SIDED|||||||||Vaccine effectiveness \<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)\*100\].||||
71920291|NCT02140762|143362457|SUPERIORITY_OR_OTHER||Vaccine effectiveness|44.0|||<|0.0001|TWO_SIDED|95.0|41.0|47.0|||General Linear Model (GLM)||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.||47|41|< 0.0001
71920292|NCT02140762|143362457|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|9.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71686837|NCT01421147|142890809|SUPERIORITY_OR_OTHER|||||||0.25||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Wilcoxon (Mann-Whitney)|||||||0.250
71686838|NCT01031004|142890859|SUPERIORITY_OR_OTHER|||||||0.0466||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.0466
71686839|NCT01031004|142890860|SUPERIORITY_OR_OTHER|||||||0.1069||95.0|||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.1069
71686840|NCT01031004|142890861|SUPERIORITY_OR_OTHER|||||||0.4605||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.4605
71686841|NCT01031004|142890862|SUPERIORITY_OR_OTHER|||||||0.5774||95.0|||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.5774
71686842|NCT01031004|142890863|SUPERIORITY_OR_OTHER|||||||0.6403||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B will not be statistically different from etafilcon A.||||0.6403
71686843|NCT01031004|142890864|SUPERIORITY_OR_OTHER|||||||0.7217||95.0|||||t-test, 2 sided|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.||||0.7217
71686844|NCT02634801|142890865|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|4.08|||<|0.0001|TWO_SIDED|95.0|2.46|6.77|||Fisher Exact|||||6.77|2.46|<.0001
71686845|NCT02634801|142890865|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.29||||0.0137|TWO_SIDED|95.0|1.06|1.56|||Fisher Exact|||||1.56|1.06|0.0137
71686846|NCT01088711|142890896|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|90.76|||||TWO_SIDED|90.0|82.7|99.37|||Difference in geometric means (GMs)|||||99.37|82.70|
71686847|NCT01088711|142890898|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|1.92|||||TWO_SIDED|90.0|1.55|2.38|||||GMR is ratio of active GLP-1 levels in omarigliptin:placebo groups.|||2.38|1.55|
71920293|NCT02140762|143362457|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|22.7|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920294|NCT02140762|143362457|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920295|NCT02140762|143362457|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|38.2|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920296|NCT02140762|143362458|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|46.0|||<|0.0001|TWO_SIDED|95.0|43.0|49.0|||Generalized Linear Model||VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is \>10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as \[1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\]x100. The combined VE across all strains will be computed by mean of a generalized linear model.||49|43|<0.0001
71686848|NCT01088711|142890899|SUPERIORITY_OR_OTHER||Ratio of geometric least-squares means|0.91|||||TWO_SIDED|90.0|0.72|1.17|||||GMR is ratio of total GLP-1 levels in omarigliptin:placebo groups.|||1.17|0.72|
71879745|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.01|STANDARD_ERROR_OF_MEAN|0.563||0.0732|TWO_SIDED|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.095|-2.114|0.0732
71879746|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.011|STANDARD_ERROR_OF_MEAN|0.563||0.0724|TWO_SIDED|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.092|-2.114|0.0724
71879747|NCT01431274|143278908|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.001|STANDARD_ERROR_OF_MEAN|0.563||0.9983|TWO_SIDED|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.104|-1.102|0.9983
71879748|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.852|STANDARD_ERROR_OF_MEAN|0.578||0.0014|TWO_SIDED|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.718|-2.985|0.0014
71879749|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.444|STANDARD_ERROR_OF_MEAN|0.576||0.4413|TWO_SIDED|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.686|-1.573|0.4413
71879750|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.437|STANDARD_ERROR_OF_MEAN|0.578||0.0129|TWO_SIDED|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||-0.304|-2.569|0.0129
71879751|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.574||0.9222|TWO_SIDED|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.070|-1.182|0.9222
71879752|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.029|STANDARD_ERROR_OF_MEAN|0.576||0.9602|TWO_SIDED|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|ANCOVA|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||1.100|-1.157|0.9602
71879753|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.415|STANDARD_ERROR_OF_MEAN|0.57||0.4669|TWO_SIDED|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.703|-1.533|0.4669
71879754|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.471|STANDARD_ERROR_OF_MEAN|0.575||0.4126|TWO_SIDED|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.656|-1.598|0.4126
71879755|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.408|STANDARD_ERROR_OF_MEAN|0.583||0.0158|TWO_SIDED|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.265|-2.551|0.0158
71879756|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.381|STANDARD_ERROR_OF_MEAN|0.582||0.0177|TWO_SIDED|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||-0.240|-2.521|0.0177
71686849|NCT01240902|142890908|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|26.0|STANDARD_ERROR_OF_MEAN|2.0|<|0.0001|TWO_SIDED|95.0|22.3|30.1|||z-test, 1 sided||Kaplan-Meier Event Rate Greenwood Standard Error|TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.||30.1|22.3|<0.0001
71686850|NCT01240902|142890908|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier|39.3|STANDARD_ERROR_OF_MEAN|4.0|||TWO_SIDED||||||||Kaplan-Meier Event Rate Greenwood Standard Error|No performance goal created, only descriptive statistics are provided.||||
71879757|NCT01431274|143278909|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.027|STANDARD_ERROR_OF_MEAN|0.58||0.9624|TWO_SIDED|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||1.109|-1.164|0.9624
71879758|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.595|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.862|0.329|<0.0001
71879759|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.64|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.907|0.373|<0.0001
71879760|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.423|STANDARD_ERROR_OF_MEAN|0.136||0.0019|TWO_SIDED|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.690|0.156|0.0019
71879761|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.446|STANDARD_ERROR_OF_MEAN|0.136||0.0011|TWO_SIDED|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.712|0.179|0.0011
71879762|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.468|STANDARD_ERROR_OF_MEAN|0.136||0.0006|TWO_SIDED|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.735|0.201|0.0006
71879763|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.172|STANDARD_ERROR_OF_MEAN|0.136||0.2045|TWO_SIDED|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.438|-0.094|0.2045
71879764|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.618|STANDARD_ERROR_OF_MEAN|0.136|<|0.0001|TWO_SIDED|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.885|0.351|<0.0001
71879765|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.045|STANDARD_ERROR_OF_MEAN|0.137||0.7432|TWO_SIDED|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.223|-0.313|0.7432
71879766|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.023|STANDARD_ERROR_OF_MEAN|0.136||0.8687|TWO_SIDED|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.245|-0.290|0.8687
71922457|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|0.781||||0.63|TWO_SIDED|95.0|-16.9|9.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.8|-16.9|0.630
71922458|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|9.4||||0.295|TWO_SIDED|95.0|-8.3|27.0|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||27.0|-8.3|0.295
71920297|NCT02140762|143362458|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|25.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920298|NCT02140762|143362458|OTHER|For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].|Vaccine Effectiveness|19.1|||||TWO_SIDED|||||||||Vaccine effectiveness\<30%||||
71920299|NCT02140762|143362458|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|10.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920300|NCT02140762|143362458|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|40.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920301|NCT02140762|143362459|SUPERIORITY_OR_OTHER||Vaccine Effectiveness|20.0|||<|0.0001|TWO_SIDED|95.0|16.0|23.0||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|Generalized Linear Model||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is \> 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as \[1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||23|16|< 0.0001
71920302|NCT02140762|143362459|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|36.4|||||TWO_SIDED|||||||||Vaccine effectiveness\<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920303|NCT02140762|143362459|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|15.5|||||TWO_SIDED|||||||||Vaccine effectiveness\<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920304|NCT02140762|143362459|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|20.9|||||TWO_SIDED|||||||||Vaccine effectiveness\<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71686851|NCT01240902|142890908|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.|||||<|0.0001|TWO_SIDED||||||z-test, 1 sided|||||||<0.0001
71686852|NCT01240902|142890909|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1033|TWO_SIDED|||||Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.|Kaplan-Meier Point Estimate|Using Greenwood formula||"Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR \< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \>80%"||||0.1033
71686853|NCT01240902|142890913|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.6|STANDARD_DEVIATION|0.9|<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 2 sided|||Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
71686854|NCT01240902|142890913|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline - NYHA1year.|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 1 sided|||"Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year."||||<0.0001
71686855|NCT01240902|142890916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #4|t-test, 2 sided|||Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.||||<0.0001
71686856|NCT01240902|142890916|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 5||||||0.0063|TWO_SIDED|||||Hierarchical test item #4|t-test, 1 sided|||"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year."||||0.0063
71686857|NCT01240902|142890916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.|t-test, 2 sided|||"Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days."||||<0.0001
71879767|NCT01431274|143278910|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.022|STANDARD_ERROR_OF_MEAN|0.137||0.8709|TWO_SIDED|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.246|-0.290|0.8709
71879768|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.63|STANDARD_ERROR_OF_MEAN|0.137|<|0.0001|TWO_SIDED|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.898|0.362|<0.0001
71686858|NCT01240902|142890917|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 2 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
71686859|NCT01240902|142890917|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 0.375|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #2|t-test, 1 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2."||||<0.0001
71882813|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.5882|STANDARD_ERROR_OF_MEAN|4.3902||0.5583|TWO_SIDED|80.0|-8.294|3.1175|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||3.1175|-8.294|0.5583
71686860|NCT01240902|142890918|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 2 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."||||<0.0001
71882814|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|7.6547|STANDARD_ERROR_OF_MEAN|4.7652||0.1141|TWO_SIDED|80.0|1.4717|13.838|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.838|1.4717|0.1141
71686861|NCT01240902|142890918|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin 15|||||<|0.0001|TWO_SIDED|||||Hierarchical test item #1|t-test, 1 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg."||||<0.0001
71686862|NCT01441245|142890928|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.04
71920305|NCT02140762|143362459|OTHER|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|11.8|||||TWO_SIDED|||||||||Vaccine effectiveness\<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= \[1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)\*100\].||||
71920306|NCT00989664|143362484|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||McNemar|||||||<0.001
71920307|NCT02055976|143362569|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.838|STANDARD_ERROR_OF_MEAN|3.775|<|0.001|TWO_SIDED|95.0|-57.335|-42.34|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.340|-57.335|<0.001
71920308|NCT02055976|143362569|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.754|STANDARD_ERROR_OF_MEAN|3.912|<|0.001|TWO_SIDED|95.0|-74.523|-58.986|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.986|-74.523|<0.001
71920309|NCT02055976|143362569|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.534|STANDARD_ERROR_OF_MEAN|3.903|<|0.001|TWO_SIDED|95.0|-79.284|-63.784|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-63.784|-79.284|<0.001
71920310|NCT02055976|143362569|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.531|STANDARD_ERROR_OF_MEAN|4.016|<|0.001|TWO_SIDED|95.0|-55.511|-39.551|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.551|-55.511|<0.001
71920311|NCT02055976|143362569|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.624|STANDARD_ERROR_OF_MEAN|3.993|<|0.001|TWO_SIDED|95.0|-70.557|-54.691|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.691|-70.557|<0.001
71686863|NCT01441245|142890929|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage and compared with chi-square test. p values \<0.05 were considered significant.||||<0.01
71920312|NCT02055976|143362569|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.268|STANDARD_ERROR_OF_MEAN|3.955|<|0.001|TWO_SIDED|95.0|-72.128|-56.409|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.409|-72.128|<0.001
71920313|NCT02055976|143362570|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-42.293|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-49.417|-35.168|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.168|-49.417|<0.001
71920314|NCT02055976|143362570|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.262|STANDARD_ERROR_OF_MEAN|3.696|<|0.001|TWO_SIDED|95.0|-63.603|-48.921|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.921|-63.603|<0.001
71920315|NCT02055976|143362570|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.384|STANDARD_ERROR_OF_MEAN|3.7|<|0.001|TWO_SIDED|95.0|-68.733|-54.035|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.035|-68.733|<0.001
71920316|NCT02055976|143362570|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.578|STANDARD_ERROR_OF_MEAN|4.273|<|0.001|TWO_SIDED|95.0|-56.067|-39.088|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.088|-56.067|<0.001
71920317|NCT02055976|143362570|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-63.346|STANDARD_ERROR_OF_MEAN|4.244|<|0.001|TWO_SIDED|95.0|-71.776|-54.915|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.915|-71.776|<0.001
71920318|NCT02055976|143362570|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.691|STANDARD_ERROR_OF_MEAN|4.226|<|0.001|TWO_SIDED|95.0|-75.088|-58.295|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.295|-75.088|<0.001
71879769|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.434|STANDARD_ERROR_OF_MEAN|0.137||0.0015|TWO_SIDED|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.703|0.166|0.0015
71879770|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.419|STANDARD_ERROR_OF_MEAN|0.137||0.0022|TWO_SIDED|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.687|0.151|0.0022
71920319|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-67.254|STANDARD_ERROR_OF_MEAN|4.785|<|0.001|TWO_SIDED|95.0|-76.757|-57.752|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.752|-76.757|<0.001
71920320|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-87.122|STANDARD_ERROR_OF_MEAN|4.959|<|0.001|TWO_SIDED|95.0|-96.969|-77.275|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-77.275|-96.969|<0.001
71686864|NCT01441245|142890930|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71686865|NCT01441245|142890931|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.02|TWO_SIDED||||||t-test, 2 sided|||||||0.02
71686866|NCT01441245|142890932|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71879771|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.227|STANDARD_ERROR_OF_MEAN|0.137||0.0966|TWO_SIDED|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.495|-0.041|0.0966
71879772|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.223|STANDARD_ERROR_OF_MEAN|0.137||0.1029|TWO_SIDED|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.492|-0.045|0.1029
71879773|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.211|STANDARD_ERROR_OF_MEAN|0.136||0.122|TWO_SIDED|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within-patient errors."|||0.478|-0.056|0.1220
71879774|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.438|STANDARD_ERROR_OF_MEAN|0.137||0.0014|TWO_SIDED|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.707|0.170|0.0014
71879775|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.196|STANDARD_ERROR_OF_MEAN|0.137||0.1542|TWO_SIDED|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.465|-0.074|0.1542
71879776|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.192|STANDARD_ERROR_OF_MEAN|0.137||0.1626|TWO_SIDED|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.461|-0.077|0.1626
71879777|NCT01431274|143278911|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.004|STANDARD_ERROR_OF_MEAN|0.138||0.9765|TWO_SIDED|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.274|-0.265|0.9765
71879778|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.647|STANDARD_ERROR_OF_MEAN|0.142|<|0.0001|TWO_SIDED|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.925|0.370|<0.0001
71879779|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.322|STANDARD_ERROR_OF_MEAN|0.141||0.0226|TWO_SIDED|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within-patient errors."|||0.600|0.045|0.0226
71879780|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.371|STANDARD_ERROR_OF_MEAN|0.142||0.0089|TWO_SIDED|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within-patient errors."|||0.649|0.093|0.0089
71882815|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5882|STANDARD_ERROR_OF_MEAN|0.1903||0.0034|TWO_SIDED|80.0|-0.8356|-0.3408|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.3408|-0.8356|0.0034
71879781|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.332|STANDARD_ERROR_OF_MEAN|0.141||0.0186|TWO_SIDED|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.609|0.056|0.0186
71879782|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.046|STANDARD_ERROR_OF_MEAN|0.142||0.7441|TWO_SIDED|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within-patient errors."|||0.324|-0.231|0.7441
71879783|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.276|STANDARD_ERROR_OF_MEAN|0.14||0.0492|TWO_SIDED|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 μg).~Spatial power covariance structure for within-patient errors."|||0.551|0.001|0.0492
71879784|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.608|STANDARD_ERROR_OF_MEAN|0.141|<|0.0001|TWO_SIDED|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within-patient errors."|||0.884|0.332|<0.0001
71879785|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.325|STANDARD_ERROR_OF_MEAN|0.143||0.023|TWO_SIDED|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within-patient errors."|||0.605|0.045|0.0230
71879786|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.039|STANDARD_ERROR_OF_MEAN|0.142||0.7855|TWO_SIDED|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.317|-0.240|0.7855
71879787|NCT01431274|143278912|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.286|STANDARD_ERROR_OF_MEAN|0.142||0.0442|TWO_SIDED|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within-patient errors."|||0.564|0.007|0.0442
71879788|NCT01748942|143278916|SUPERIORITY|||||||0.25|||||||Mixed Models Analysis|||||||0.25
71879789|NCT01748942|143278919|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71879790|NCT01748942|143278920|SUPERIORITY|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||||||0.009
71920321|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-93.327|STANDARD_ERROR_OF_MEAN|4.949|<|0.001|TWO_SIDED|95.0|-103.153|-83.501|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.501|-103.153|<0.001
71920322|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.724|STANDARD_ERROR_OF_MEAN|6.243|<|0.001|TWO_SIDED|95.0|-84.128|-59.321|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.321|-84.128|<0.001
71920323|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.206|STANDARD_ERROR_OF_MEAN|6.209|<|0.001|TWO_SIDED|95.0|-108.541|-83.872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-83.872|-108.541|<0.001
71920324|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.533|STANDARD_ERROR_OF_MEAN|6.145|<|0.001|TWO_SIDED|95.0|-110.743|-86.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.323|-110.743|<0.001
71920325|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.225|STANDARD_ERROR_OF_MEAN|4.736|<|0.001|TWO_SIDED|95.0|-65.63|-46.819|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.819|-65.630|<0.001
71879791|NCT01748942|143278921|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71879792|NCT01748942|143278922|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71879793|NCT01748942|143278923|SUPERIORITY|||||||0.15|||||||Log Rank|||||||0.15
71879794|NCT03184077|143278958|SUPERIORITY|||||||0.16|||||||Chi-squared|||||||0.16
71879795|NCT03184077|143278959|SUPERIORITY|||||||0.62|||||||Chi-squared|||||||0.62
71879796|NCT03184077|143278960|SUPERIORITY|||||||0.01||||||This is a calculated p value|Chi-squared|||||||0.01
71879797|NCT02046096|143278965|OTHER||12-month rate (%)|97.8|||<|0.0001|TWO_SIDED|95.0|95.6|99.1||The threshold for statistical significance was p = 0.025|One-tailed Exact binomial test||The 95% confidence interval was computed using Exact method.|Null Hypothesis: The rate of technical placement success and 12-month freedom from new symptomatic PE while a filter is indwelling, π, does not meet the performance goal (90%).||99.1|95.6|<0.0001
71879798|NCT02046096|143278966|OTHER||Cumulative probability|81.5|STANDARD_ERROR_OF_MEAN|4.5||0.369|TWO_SIDED|95.0|72.6|90.4||the threshold for statistical significance is 0.025.|Z-statistic|The hypothesis is assessed using a Z-statistic. The Z-statistic is given by Z = (Ŝ(t) - 0.8) / SE where SE is the Standard Error|The estimate of the variance of the Kaplan-Meier estimate used the methods described by Peto et al.|"the null hypotheses is: H0: S(t) ≤ 80%(Performance Goal) where,~* t is time through 12 months~* S(t) is the true rate of freedom from major adverse events at time t."||90.4|72.6|0.369
71879799|NCT02046096|143278967|OTHER||12-month freedom from MAE rate (%)|86.7||||0.001|TWO_SIDED|95.0|82.5|90.2||The threshold for statistical significance was p = 0.025|One-tailed exact binomial test|||Null Hypothesis: The 12-month freedom from MAE, π, does not meet the performance goal (80%).||90.2|82.5|0.001
71879800|NCT00597753|143278996|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.072|||TWO_SIDED|95.0|-0.3|-0.01|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin alfa group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||-0.01|-0.30|
71879801|NCT00597753|143278997|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21|||||TWO_SIDED|95.0|0.76|1.92|||Cochran-Mantel-Haenszel|||||1.92|0.76|
71879802|NCT00597753|143278998|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88|||||TWO_SIDED|95.0|0.79|0.97|||Cochran-Mantel-Haenszel|||||0.97|0.79|
71879803|NCT01469182|143279029|SUPERIORITY_OR_OTHER||Percent Difference|9.95||||0.005|TWO_SIDED|95.0|3.1|16.7|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||16.7|3.1|0.005
71879804|NCT01469182|143279030|SUPERIORITY_OR_OTHER||Percent Difference|5.58|||<|0.001|TWO_SIDED|95.0|2.9|8.2|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||8.2|2.9|<0.001
71879805|NCT01469182|143279031|SUPERIORITY_OR_OTHER||Percent Difference|7.88|||<|0.001|TWO_SIDED|95.0|5.5|10.5|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||10.5|5.5|<0.001
71920326|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.813|STANDARD_ERROR_OF_MEAN|4.881|<|0.001|TWO_SIDED|95.0|-83.507|-64.119|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.119|-83.507|<0.001
71879806|NCT01469182|143279032|SUPERIORITY_OR_OTHER||Percent Difference|10.17|||<|0.001|TWO_SIDED|95.0|6.6|13.6|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||13.6|6.6|<0.001
71879807|NCT01469182|143279033|SUPERIORITY_OR_OTHER||Percent Difference|5.25|||<|0.001|TWO_SIDED|95.0|3.3|7.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||7.4|3.3|<0.001
71879808|NCT01469182|143279034|SUPERIORITY_OR_OTHER||Percent Difference|0.17||||0.861|TWO_SIDED|95.0|-2.1|1.9|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||1.9|-2.1|0.861
71879809|NCT01469182|143279035|SUPERIORITY_OR_OTHER||Percent Difference|1.15||||0.344||95.0|-1.5|3.3|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.3|-1.5|0.344
71879810|NCT01469182|143279036|SUPERIORITY_OR_OTHER||Percent Difference|0.99||||0.382|TWO_SIDED|95.0|-1.5|3.0|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||3.0|-1.5|0.382
71879811|NCT01469182|143279037|SUPERIORITY_OR_OTHER||Percent Difference|2.46||||0.029|TWO_SIDED|95.0|0.3|4.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor||||4.4|0.3|0.029
71879812|NCT02687542|143279038|OTHER|Bayesian Dose Response Analysis|Bayesian Dose Reponse Estimate|-0.693|STANDARD_ERROR_OF_MEAN|0.6162||0.5776|TWO_SIDED|90.0|-1.713|0.304||Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity|Bayesian Dose Response Analysis|Estimate and 90% credible interval of Bayesian dose response difference from placebo||||0.304|-1.713|0.5776
71879813|NCT02114164|143279051|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71879814|NCT02114164|143279052|OTHER|||||||0.39|||||||t-test, 2 sided|||||||0.39
71879815|NCT02114164|143279053|OTHER|||||||0.13||||||Comparison at baseline|t-test, 2 sided|||||||0.13
71879816|NCT02114164|143279053|OTHER|||||||0.018||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.018
71879817|NCT02114164|143279053|OTHER|||||||0.712||||||Comparison at end of procedure|t-test, 2 sided|||||||0.712
71879818|NCT02114164|143279054|OTHER|||||||0.42||||||Comparison at baseline|t-test, 2 sided|||||||0.42
71879819|NCT02114164|143279054|OTHER|||||||0.75||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.75
71879820|NCT02114164|143279054|OTHER|||||||0.99||||||Comparison at end of procedure|t-test, 2 sided|||||||0.99
71879821|NCT02114164|143279055|OTHER|||||||0.88||||||Comparison at baseline|t-test, 2 sided|||||||0.88
71879822|NCT02114164|143279055|OTHER|||||||0.65||||||Comparison at 60 minutes|t-test, 2 sided|||||||0.65
71879823|NCT02114164|143279055|OTHER|||||||0.86||||||Comparison at end of procedure|t-test, 2 sided|||||||0.86
71879824|NCT02114164|143279056|OTHER|Number of interventions required by the anesthesiologists were compared between the AirSeal and standard Endopath groups using zero-inflated Poisson regression||||||0.41|||||||Zero-inflated Poisson regression|||||||0.41
71879825|NCT02114164|143279057|OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71879826|NCT02114164|143279058|OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71879827|NCT00111800|143279090|SUPERIORITY||Mean Difference (Net)|-0.28||||0.061|TWO_SIDED|95.0|-0.58|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.58|0.061
71879828|NCT00111800|143279090|SUPERIORITY||Mean Difference (Net)|-0.53|||<|0.001|TWO_SIDED|95.0|-0.82|-0.24|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.24|-0.82|<0.001
71879829|NCT00111800|143279090|SUPERIORITY||Mean Difference (Net)|-0.45||||0.002|TWO_SIDED|95.0|-0.74|-0.16|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.16|-0.74|0.002
71879830|NCT00111800|143279090|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.09|-0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.50|-1.09|<0.001
71879831|NCT00111800|143279090|SUPERIORITY||Mean Difference (Net)|-0.84|||<|0.001|TWO_SIDED|95.0|-1.13|-0.55|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.55|-1.13|<0.001
71879832|NCT00111800|143279092|SUPERIORITY||Mean Difference (Net)|-0.4||||0.306|TWO_SIDED|95.0|-1.18|0.37|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.37|-1.18|0.306
71879833|NCT00111800|143279092|SUPERIORITY||Mean Difference (Net)|-0.8||||0.039|TWO_SIDED|95.0|-1.56|-0.04|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.04|-1.56|0.039
71920327|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.239|STANDARD_ERROR_OF_MEAN|4.885|<|0.001|TWO_SIDED|95.0|-90.939|-71.538|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.538|-90.939|<0.001
71920328|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.573|STANDARD_ERROR_OF_MEAN|5.983|<|0.001|TWO_SIDED|95.0|-84.461|-60.684|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.684|-84.461|<0.001
71920329|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-96.222|STANDARD_ERROR_OF_MEAN|5.948|<|0.001|TWO_SIDED|95.0|-108.039|-84.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.405|-108.039|<0.001
71920330|NCT02055976|143362572|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-102.184|STANDARD_ERROR_OF_MEAN|5.919|<|0.001|TWO_SIDED|95.0|-113.945|-90.424|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.424|-113.945|<0.001
71686867|NCT01441245|142890932|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|Risk Ratio (RR)|2.06||||0.01|TWO_SIDED|95.0|1.65|2.57|||Regression, Linear||BNP levels at discharge \>500 pg/ml (RR: 2.06 \[1.65-2.57\];).|||2.57|1.65|0.01
71879834|NCT00111800|143279092|SUPERIORITY||Mean Difference (Net)|-0.58||||0.13|TWO_SIDED|95.0|-1.34|0.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.17|-1.34|0.130
71879835|NCT00111800|143279092|SUPERIORITY||Mean Difference (Net)|-1.46|||<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.69|-2.23|<0.001
71879836|NCT00111800|143279092|SUPERIORITY||Mean Difference (Net)|-1.22||||0.002|TWO_SIDED|95.0|-1.99|-0.46|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.46|-1.99|0.002
71879837|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|0.92||||0.909|TWO_SIDED|95.0|0.21|3.95|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.95|0.21|0.909
71879838|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.15||||0.852|TWO_SIDED|95.0|0.27|4.92|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.92|0.27|0.852
71879839|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.2||||0.795|TWO_SIDED|95.0|0.3|4.83|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.83|0.30|0.795
71879840|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|2.68||||0.135|TWO_SIDED|95.0|0.74|9.77|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.77|0.74|0.135
71879841|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|3.24||||0.085|TWO_SIDED|95.0|0.85|12.37|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||12.37|0.85|0.085
71879842|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.1||||0.866|TWO_SIDED|95.0|0.36|3.36|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.36|0.36|0.866
71879843|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.99||||0.202|TWO_SIDED|95.0|0.69|5.76|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.76|0.69|0.202
71879844|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.04||||0.941|TWO_SIDED|95.0|0.35|3.13|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.13|0.35|0.941
71879845|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|2.15||||0.152|TWO_SIDED|95.0|0.76|6.13|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.13|0.76|0.152
71879846|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|3.24||||0.032|TWO_SIDED|95.0|1.11|9.52|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c \<7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.52|1.11|0.032
71879847|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|0.46||||0.198|TWO_SIDED|95.0|0.14|1.5|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||1.50|0.14|0.198
71879848|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.43||||0.481|TWO_SIDED|95.0|0.53|3.85|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||3.85|0.53|0.481
71879849|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.36|2.78|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||2.78|0.36|0.991
71879850|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|3.65||||0.008|TWO_SIDED|95.0|1.41|9.48|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c reduction \>=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.48|1.41|0.008
71879851|NCT00111800|143279094|SUPERIORITY||Odds Ratio (OR)|2.0||||0.161|TWO_SIDED|95.0|0.76|5.24|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c reduction \>=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.24|0.76|0.161
71920331|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-69.537|STANDARD_ERROR_OF_MEAN|5.721|<|0.001|TWO_SIDED|95.0|-80.9|-58.175|||Mixed Models Analysis|One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.175|-80.900|<0.001
71920332|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-86.446|STANDARD_ERROR_OF_MEAN|5.855|<|0.001|TWO_SIDED|95.0|-98.074|-74.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-74.818|-98.074|<0.001
71879852|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|1.77||||0.38|TWO_SIDED|95.0|0.5|6.3|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.30|0.50|0.380
71879853|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|2.57||||0.145|TWO_SIDED|95.0|0.72|9.11|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.11|0.72|0.145
71879854|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|1.09||||0.906|TWO_SIDED|95.0|0.26|4.62|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.26|0.906
71879855|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|1.56||||0.509|TWO_SIDED|95.0|0.41|5.91|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.91|0.41|0.509
71879856|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|3.14||||0.077|TWO_SIDED|95.0|0.89|11.14|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG \<7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||11.14|0.89|0.077
71879857|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|1.9||||0.254|TWO_SIDED|95.0|0.63|5.72|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||5.72|0.63|0.254
71879858|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|1.59||||0.396|TWO_SIDED|95.0|0.55|4.62|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.62|0.55|0.396
71920333|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.273|STANDARD_ERROR_OF_MEAN|5.898|<|0.001|TWO_SIDED|95.0|-109.983|-86.563|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-86.563|-109.983|<0.001
71920334|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.435|STANDARD_ERROR_OF_MEAN|7.209|<|0.001|TWO_SIDED|95.0|-85.757|-57.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.112|-85.757|<0.001
71920335|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-94.959|STANDARD_ERROR_OF_MEAN|7.236|<|0.001|TWO_SIDED|95.0|-109.333|-80.585|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-80.585|-109.333|<0.001
71920336|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-98.519|STANDARD_ERROR_OF_MEAN|7.15|<|0.001|TWO_SIDED|95.0|-112.727|-84.311|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.311|-112.727|<0.001
71920337|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.191|STANDARD_ERROR_OF_MEAN|5.741|<|0.001|TWO_SIDED|95.0|-66.592|-43.791|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-43.791|-66.592|<0.001
71920338|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-72.211|STANDARD_ERROR_OF_MEAN|5.848|<|0.001|TWO_SIDED|95.0|-83.825|-60.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.597|-83.825|<0.001
71920339|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-83.065|STANDARD_ERROR_OF_MEAN|5.913|<|0.001|TWO_SIDED|95.0|-94.807|-71.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-71.323|-94.807|<0.001
71920340|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-73.879|STANDARD_ERROR_OF_MEAN|6.678|<|0.001|TWO_SIDED|95.0|-87.147|-60.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-60.612|-87.147|<0.001
71920341|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.428|STANDARD_ERROR_OF_MEAN|6.697||0.001|TWO_SIDED|95.0|-108.732|-82.124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-82.124|-108.732|0.001
71879859|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|1.35||||0.59|TWO_SIDED|95.0|0.45|4.0|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.00|0.45|0.590
71879860|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|3.24||||0.026|TWO_SIDED|95.0|1.15|9.13|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.13|1.15|0.026
71879861|NCT00111800|143279095|SUPERIORITY||Odds Ratio (OR)|3.0||||0.034|TWO_SIDED|95.0|1.08|8.3|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG reduction \>=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||8.30|1.08|0.034
71879862|NCT00111800|143279096|SUPERIORITY||Mean Difference (Net)|-14.9||||0.057||95.0|-30.2|0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.5|-30.2|0.057
71879863|NCT00111800|143279096|SUPERIORITY||Mean Difference (Net)|-22.4||||0.003||95.0|-37.1|-7.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-7.6|-37.1|0.003
71879864|NCT00111800|143279096|SUPERIORITY||Mean Difference (Net)|-29.2|||<|0.001||95.0|-43.9|-14.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-14.5|-43.9|<0.001
71879865|NCT00111800|143279096|SUPERIORITY||Mean Difference (Net)|-39.6|||<|0.001|TWO_SIDED|95.0|-54.6|-24.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-24.6|-54.6|<0.001
71879866|NCT00111800|143279096|SUPERIORITY||Mean Difference (Net)|-38.9|||<|0.001|TWO_SIDED|95.0|-53.8|-23.9|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-23.9|-53.8|<0.001
71879867|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|-8.51||||0.489|TWO_SIDED|95.0|-32.66|15.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for fasting serum insulin.|Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||15.65|-32.66|0.489
71879868|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|14.18||||0.237|TWO_SIDED|95.0|-9.37|37.72|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for fasting serum insulin.|Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||37.72|-9.37|0.237
71879869|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|7.31||||0.534||95.0|-15.79|30.42|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for fasting serum insulin.|Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||30.42|-15.79|0.534
71879870|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|5.27||||0.665|TWO_SIDED|95.0|-18.64|29.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for fasting serum insulin.|Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||29.17|-18.64|0.665
71879871|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|12.74||||0.295|TWO_SIDED|95.0|-11.18|36.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for fasting serum insulin.|Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||36.65|-11.18|0.295
71879872|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|3.31||||0.327|TWO_SIDED|95.0|-3.32|9.94|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for pro-insulin.|Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.94|-3.32|0.327
71879873|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|3.06||||0.345|TWO_SIDED|95.0|-3.31|9.44|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for pro-insulin.|Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.44|-3.31|0.345
71879874|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|-0.35||||0.914|TWO_SIDED|95.0|-6.7|6.0|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for pro-insulin.|Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||6.00|-6.70|0.914
71920342|NCT02055976|143362574|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-104.859|STANDARD_ERROR_OF_MEAN|6.654|<|0.001|TWO_SIDED|95.0|-118.079|-91.639|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-91.639|-118.079|<0.001
71920343|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.642|STANDARD_ERROR_OF_MEAN|2.717|<|0.001|TWO_SIDED|95.0|-37.039|-26.246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.246|-37.039|<0.001
71920344|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.88|STANDARD_ERROR_OF_MEAN|2.781|<|0.001|TWO_SIDED|95.0|-45.403|-34.358|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.358|-45.403|<0.001
71920345|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.889|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-51.45|-40.329|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.329|-51.450|<0.001
71920346|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.137|STANDARD_ERROR_OF_MEAN|3.006|<|0.001|TWO_SIDED|95.0|-36.11|-24.164|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-24.164|-36.110|<0.001
71920347|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.525|STANDARD_ERROR_OF_MEAN|3.018|<|0.001|TWO_SIDED|95.0|-45.52|-33.531|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.531|-45.520|<0.001
71920348|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.372|STANDARD_ERROR_OF_MEAN|2.983|<|0.001|TWO_SIDED|95.0|-47.299|-35.445|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.445|-47.299|<0.001
71920349|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.374|STANDARD_ERROR_OF_MEAN|2.69|<|0.001|TWO_SIDED|95.0|-30.717|-20.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-20.032|-30.717|<0.001
71920350|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.49|STANDARD_ERROR_OF_MEAN|2.741|<|0.001|TWO_SIDED|95.0|-38.934|-28.047|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.047|-38.934|<0.001
71920351|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.76|STANDARD_ERROR_OF_MEAN|2.77|<|0.001|TWO_SIDED|95.0|-44.262|-33.258|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.258|-44.262|<0.001
71920352|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-30.847|STANDARD_ERROR_OF_MEAN|2.879|<|0.001|TWO_SIDED|95.0|-36.568|-25.127|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.127|-36.568|<0.001
71920353|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.019|STANDARD_ERROR_OF_MEAN|2.887|<|0.001|TWO_SIDED|95.0|-45.754|-34.285|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.285|-45.754|<0.001
71879875|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|-2.21||||0.504|TWO_SIDED|95.0|-8.71|4.29|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for pro-insulin.|Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||4.29|-8.71|0.504
71879876|NCT00111800|143279098|SUPERIORITY||Mean Difference (Net)|2.75||||0.403|TWO_SIDED|95.0|-3.71|9.22|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for pro-insulin.|Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||9.22|-3.71|0.403
71879877|NCT00111800|143279101|SUPERIORITY||Mean Difference (Net)|0.03||||0.286|TWO_SIDED|95.0|-0.02|0.08|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.08|-0.02|0.286
71879878|NCT00111800|143279101|SUPERIORITY||Mean Difference (Net)|-0.02||||0.457|TWO_SIDED|95.0|-0.07|0.03|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.03|-0.07|0.457
71879879|NCT00111800|143279101|SUPERIORITY||Mean Difference (Net)|-0.04||||0.136|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.136
71879880|NCT00111800|143279101|SUPERIORITY||Mean Difference (Net)|-0.06||||0.021|TWO_SIDED|95.0|-0.11|-0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||-0.01|-0.11|0.021
71879881|NCT00111800|143279101|SUPERIORITY||Mean Difference (Net)|-0.04||||0.094|TWO_SIDED|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.||0.01|-0.09|0.094
71879882|NCT01549275|143279117|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom =1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cells between two groups.||||< 0.005
71879883|NCT01549275|143279117|SUPERIORITY_OR_OTHER||||||<|0.005|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured HCC cells with or without concomitant cancer-associated fibroblasts between two groups.||||< 0.005
71879884|NCT01549275|143279117|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cancer-associated fibroblasts alone between two groups.||||> 0.1
71879885|NCT01549275|143279118|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||1
71879886|NCT01549275|143279118|SUPERIORITY_OR_OTHER|||||||0.032|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.032
71879887|NCT01549275|143279118|SUPERIORITY_OR_OTHER|||||||0.048|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.048
71879888|NCT01549275|143279118|SUPERIORITY_OR_OTHER|||||||0.176|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.176
71879889|NCT01549275|143279118|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells.||||0.021
71879890|NCT01549275|143279118|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.||||0.129
71879891|NCT03448068|143279119|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71920354|NCT02055976|143362575|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.947|STANDARD_ERROR_OF_MEAN|2.869|<|0.001|TWO_SIDED|95.0|-49.647|-38.247|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.247|-49.647|<0.001
71920355|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.118|STANDARD_ERROR_OF_MEAN|3.344|<|0.001|TWO_SIDED|95.0|-47.76|-34.476|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-34.476|-47.760|<0.001
71879892|NCT03448068|143279120|SUPERIORITY|||||||0.2252|||||||t-test, 2 sided|||||||0.2252
71879893|NCT03448068|143279121|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.0610
71879894|NCT03448068|143279122|SUPERIORITY|||||||0.272|||||||t-test, 2 sided|||||||0.2720
71879895|NCT03448068|143279123|SUPERIORITY|||||||0.7298|||||||Chi-squared|||Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapy||||0.7298
71879896|NCT03448068|143279123|SUPERIORITY|||||||0.1058|||||||Chi-squared|||Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapy||||0.1058
71879897|NCT03448068|143279123|SUPERIORITY|||||||1|||||||Chi-squared|||Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapy||||1.000
71879898|NCT03448068|143279124|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||0.2
71879899|NCT01471015|143279138|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.006
71879900|NCT01471015|143279139|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.003
71879901|NCT01843842|143279140|SUPERIORITY|||||||0.016|||||||Global Test Statistic|See O'Brien 1984, Pocock 1997.||||||0.016
71879902|NCT01843842|143279141|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71879903|NCT01843842|143279142|SUPERIORITY||||||>|0.05|||||||Fisher Exact|||||||>0.05
71879904|NCT01843842|143279143|SUPERIORITY|||||||0.0283||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Day 3, doctor's examination)||||0.0283
71879905|NCT01843842|143279143|SUPERIORITY|||||||0.3264|||||||Kruskal-Wallis|||Non-specific (Day 3, doctor's examination)||||0.3264
71879906|NCT01843842|143279143|SUPERIORITY|||||||0.706|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Day 3, doctor's examination)||||0.7060
71879907|NCT01843842|143279143|SUPERIORITY|||||||0.25|||||||Kruskal-Wallis|||All symptoms (Day 3, doctor's examination)||||0.25
71879908|NCT01843842|143279143|SUPERIORITY|||||||0.244|||||||ANCOVA|||Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)||||0.244
71879909|NCT01843842|143279144|SUPERIORITY|||||||0.1158|||||||Kruskal-Wallis|||Duration of fever based on Patient Diary Data||||0.1158
71920356|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.787|STANDARD_ERROR_OF_MEAN|3.402|<|0.001|TWO_SIDED|95.0|-61.543|-48.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.032|-61.543|<0.001
71920357|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-60.549|STANDARD_ERROR_OF_MEAN|3.453|<|0.001|TWO_SIDED|95.0|-67.403|-53.694|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.694|-67.403|<0.001
71879910|NCT01843842|143279144|SUPERIORITY|||||||0.5755|||||||Kruskal-Wallis|||Duration of non-specific symptoms based on Patient Diary Data||||0.5755
71879911|NCT01843842|143279144|SUPERIORITY|||||||0.4331|||||||Kruskal-Wallis|||Duration of nasal/ throat/ chest symptoms based on Patient Diary Data||||0.4331
71879912|NCT01843842|143279144|SUPERIORITY|||||||0.356|||||||Kruskal-Wallis|||Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data||||0.3560
71879913|NCT01843842|143279145|SUPERIORITY|||||||0.0166||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1, 3, 6 doctor's examination)||||0.0166
71879914|NCT01843842|143279145|SUPERIORITY|||||||0.082|||||||Kruskal-Wallis|||Non-specific (Days 1, 3, 6 doctor's examination)||||0.0820
71879915|NCT01843842|143279145|SUPERIORITY|||||||0.7227|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)||||0.7227
71879916|NCT01843842|143279145|SUPERIORITY|||||||0.2645|||||||Kruskal-Wallis|||All symptoms (Days 1, 3, 6 doctor's examination)||||0.2645
71879917|NCT01843842|143279145|SUPERIORITY|||||||0.0142||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1-5, patient diary data)||||0.0142
71879918|NCT01843842|143279145|SUPERIORITY|||||||0.0145||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Non-specific (Days 1-5, patient diary data)||||0.0145
71879919|NCT01843842|143279145|SUPERIORITY|||||||0.2963|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1-5, patient diary data)||||0.2963
71879920|NCT01843842|143279145|SUPERIORITY|||||||0.0364||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||All symptoms (Days 1-5, patient diary data)||||0.0364
71879921|NCT01843842|143279146|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.40
71879922|NCT01376778|143279148|SUPERIORITY||Risk Ratio (RR)|1.17||||0.42|TWO_SIDED|95.0|0.8|1.72|||Chi-squared|||||1.72|0.80|0.42
71879923|NCT01376778|143279153|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.86|3.03||||||||3.03|0.86|
71879924|NCT01376778|143279154|SUPERIORITY||Risk Ratio (RR)|2.82|||||TWO_SIDED|95.0|0.29|72.42||||||||72.42|0.29|
71879925|NCT01376778|143279155|SUPERIORITY||Risk Difference (RD)|-0.41|||||TWO_SIDED|||||||||||||
71879926|NCT01376778|143279156|SUPERIORITY||Risk Ratio (RR)|1.47|||||TWO_SIDED|95.0|0.81|2.67||||||||2.67|0.81|
71879927|NCT01376778|143279157|SUPERIORITY||Risk Ratio (RR)|1.61|||||TWO_SIDED|95.0|0.65|4.01||||||||4.01|0.65|
71879928|NCT01376778|143279159|SUPERIORITY||Risk Ratio (RR)|1.88|||||TWO_SIDED|95.0|0.66|5.41||||||||5.41|0.66|
71879929|NCT01376778|143279160|SUPERIORITY||Risk Difference (RD)|-0.25|||||TWO_SIDED|95.0|-0.66|0.15||||||||0.15|-0.66|
71879930|NCT01376778|143279161|SUPERIORITY||Risk Difference (RD)|-35.0|||||TWO_SIDED|95.0|-157.0|87.0||||||||87|-157|
71879931|NCT01376778|143279162|SUPERIORITY||Risk Ratio (RR)|1.92|||||TWO_SIDED|95.0|0.92|3.99||||||||3.99|0.92|
71879932|NCT01376778|143279166|SUPERIORITY||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.03|31.5||||||||31.5|0.03|
71879933|NCT01376778|143279167|SUPERIORITY||Risk Ratio (RR)|0.48|||||TWO_SIDED|95.0|0.17|1.38||||||||1.38|0.17|
71879934|NCT01376778|143279170|SUPERIORITY||Risk Ratio (RR)|0.63|||||TWO_SIDED|95.0|0.32|1.23||||||||1.23|0.32|
71879935|NCT01376778|143279171|SUPERIORITY||Risk Ratio (RR)|0.84|||||TWO_SIDED|95.0|0.42|1.68||||||||1.68|0.42|
71879936|NCT01376778|143279172|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.17|5.23||||||||5.23|0.17|
71879937|NCT01376778|143279180|SUPERIORITY||Risk Ratio (RR)|1.3||||0.37|TWO_SIDED|95.0|0.7|2.5|||Chi-squared|||||2.5|0.7|0.37
71879938|NCT01376778|143279181|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
71686868|NCT01441245|142890933|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.03|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.03
71879939|NCT01376778|143279182|SUPERIORITY|||||||0.84|||||||Chi-squared|||||||0.84
71879940|NCT01309659|143279234|SUPERIORITY_OR_OTHER|||||||0.308|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the immediate intervention group. Testing the correlation equal to 0.|t-test, 2 sided|||||||0.308
71879941|NCT01309659|143279234|SUPERIORITY_OR_OTHER|||||||0.601|TWO_SIDED|||||Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.601
71879942|NCT01309659|143279234|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.396
71879943|NCT01309659|143279234|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED|||||Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.106
71879944|NCT01309659|143279234|SUPERIORITY_OR_OTHER|||||||0.606|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0.|t-test, 2 sided|||||||0.606
71879945|NCT01309659|143279234|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided|||||||0.077
71879946|NCT01309659|143279243|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the immediate intervention group. Testing the correlation =0.|t-test, 2 sided|||||||0.649
71879947|NCT01309659|143279243|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0.|t-test, 2 sided|||||||0.001
71879948|NCT01309659|143279244|SUPERIORITY_OR_OTHER|||||||0.391|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.391
71879949|NCT01309659|143279244|SUPERIORITY_OR_OTHER|||||||0.111|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0.|t-test, 2 sided|||||||0.111
71879950|NCT01309659|143279245|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.077
71879951|NCT01309659|143279245|SUPERIORITY_OR_OTHER|||||||0.798|TWO_SIDED|||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.798
71879952|NCT01309659|143279245|SUPERIORITY_OR_OTHER|||||||0.383|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.383
71879953|NCT01309659|143279245|SUPERIORITY_OR_OTHER|||||||0.732|TWO_SIDED|||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.732
71879954|NCT01309659|143279245|SUPERIORITY_OR_OTHER|||||||0.286|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.286
71879955|NCT01309659|143279245|SUPERIORITY_OR_OTHER|||||||0.356|TWO_SIDED|||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.356
71879956|NCT01309659|143279246|SUPERIORITY_OR_OTHER|||||||0.649|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the immediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.649
71879957|NCT01309659|143279246|SUPERIORITY_OR_OTHER|||||||0.396|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.396
71879958|NCT01309659|143279247|SUPERIORITY_OR_OTHER|||||||0.624|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the intermediate intervention group. Testing correlation =0.|t-test, 2 sided|||||||0.624
71879959|NCT01309659|143279247|SUPERIORITY_OR_OTHER|||||||0.329|TWO_SIDED|||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0.|t-test, 2 sided|||||||0.329
71879960|NCT02285777|143279254|OTHER|Pre-specified.|Vaccine Effectiveness|71.0||||0.0001|TWO_SIDED|95.0|69.0|73.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100.The combined VE across all strains was computed by mean of a generalized linear model.||73|69|0.0001
71879961|NCT02285777|143279255|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|55.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||55|48|0.0001
71879962|NCT02285777|143279256|OTHER|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|TWO_SIDED|95.0|48.0|54.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||54|48|0.0001
71879963|NCT02285777|143279256|OTHER|Pre-specified.|Vaccine Effectiveness|24.0||||0.0001||95.0|20.0|28.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION \& LOG LINK options were used to compute log10 RR \& corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as \[1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)\] x 100. The combined VE across all strains was computed by mean of a generalized linear model.||28|20|0.0001
71879964|NCT00271596|143279294|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166|STANDARD_ERROR_OF_MEAN|0.098||0.092|TWO_SIDED|95.0|-0.361|0.028|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.028|-0.361|0.092
71879965|NCT00271596|143279295|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.337|STANDARD_ERROR_OF_MEAN|0.168||0.048|TWO_SIDED|95.0|-0.672|-0.003|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||-0.003|-0.672|0.048
71879966|NCT00271596|143279296|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.278|STANDARD_ERROR_OF_MEAN|0.268||0.302|TWO_SIDED|95.0|-0.81|0.254|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.254|-0.810|0.302
71879967|NCT00271596|143279297|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.153||0.708|TWO_SIDED|95.0|-0.361|0.246|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.246|-0.361|0.708
71879968|NCT00271596|143279298|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069|STANDARD_ERROR_OF_MEAN|0.15||0.646|TWO_SIDED|95.0|-0.229|0.367|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.367|-0.229|0.646
71879969|NCT00271596|143279299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.174||0.23||95.0|-0.554|0.135|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.135|-0.554|0.230
71879970|NCT00271596|143279300|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.317|STANDARD_ERROR_OF_MEAN|0.482||0.512|TWO_SIDED|95.0|-1.276|0.642|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.642|-1.276|0.512
71879971|NCT00271596|143279301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.17||0.12|TWO_SIDED|95.0|-4.3|0.5|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.50|-4.30|0.12
71879972|NCT00271596|143279302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.68||0.49|TWO_SIDED|95.0|-1.87|0.91|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.91|-1.87|0.49
71879973|NCT00271596|143279303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|-2.5|STANDARD_ERROR_OF_MEAN|1.23||0.05|TWO_SIDED|95.0|-5.04|0.04||Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|Mixed Models Analysis|||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||0.04|-5.04|0.05
71879974|NCT04206605|143279316|SUPERIORITY||Rate Ratio|1.02|||=|0.899|TWO_SIDED|95.0|0.71|1.47||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.47|0.71|=0.899
71686869|NCT01441245|142890934|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant.||||0.01
71879975|NCT04206605|143279317|SUPERIORITY||Risk Difference (RD)|0.003|||=|1|TWO_SIDED|95.0|-0.153|0.114||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from Cochran-Mantel-Haenszel (CMH) test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.114|-0.153|=1.000
71879976|NCT04206605|143279318|SUPERIORITY||Rate Ratio|0.96|||=|0.852|TWO_SIDED|95.0|0.62|1.48||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.48|0.62|=0.852
71879977|NCT04206605|143279319|SUPERIORITY||Rate Ratio|1.1|||=|0.66|TWO_SIDED|95.0|0.72|1.7||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.70|0.72|=0.660
71686870|NCT01441245|142890935|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.05|TWO_SIDED||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values \<0.05 were considered significant||||0.05
71686871|NCT01441245|142890936|NON_INFERIORITY_OR_EQUIVALENCE|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|TWO_SIDED||||||Chi-squared|||Qualitative variables are expressed as percentage of partecipants and compared with chi-square test. p-value equal or lower than 0.05 are considered statistically significant.||||<0.01
71686872|NCT01649362|142890951|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||||||0.63
71686873|NCT01649362|142890952|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||||||0.36
71686874|NCT01649362|142890953|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||Chi-squared|||||||0.02
71686875|NCT03441685|142890956|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.73||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.73
71686876|NCT03441685|142890956|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.69||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.69
71686877|NCT03441685|142890956|OTHER|Accuracy identifying taught verbs in syntactic vs semantic condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
71686878|NCT03441685|142890956|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.002||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.002
71686879|NCT03441685|142890956|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.049||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.049
71686880|NCT03441685|142890956|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.016||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.016
71686881|NCT03441685|142890957|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.76||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.76
71686882|NCT03441685|142890957|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||0.79||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.79
71686883|NCT03441685|142890957|OTHER|Accuracy identifying taught verbs in semantic vs combined condition (receptive)||||||1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||1.00
71686884|NCT03441685|142890957|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.003||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.003
71686885|NCT03441685|142890957|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.029||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.029
71686886|NCT03441685|142890957|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
71686887|NCT03441685|142890958|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.72||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.72
71686888|NCT03441685|142890958|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.46||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.46
71686889|NCT03441685|142890958|OTHER|Accuracy identifying taught verbs in syntactic vs combined condition (receptive)||||||0.89||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.89
71686890|NCT03441685|142890958|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
71686891|NCT03441685|142890958|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.018||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.018
71686892|NCT03441685|142890958|OTHER|One-sample Wilcoxon signed rank test with comparison value of 6.||||||0.027||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.027
71686893|NCT03441685|142890959|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.64||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.64
71686894|NCT03441685|142890959|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.16||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.16
71686895|NCT03441685|142890959|OTHER|Accuracy labeling taught verbs in syntactic vs semantic condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
71686896|NCT03441685|142890959|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
71686897|NCT03441685|142890959|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.034||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.034
71686898|NCT03441685|142890959|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.063||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.063
71686899|NCT03441685|142890960|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.35||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.35
71686900|NCT03441685|142890960|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.18||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.18
71686901|NCT03441685|142890960|OTHER|Accuracy labeling taught verbs in semantic vs combined condition (expressive)||||||0.58|||||||Wilcoxon Signed Ranks Test|||||||0.58
71686902|NCT03441685|142890960|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.006||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.006
71686903|NCT03441685|142890960|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.02||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.02
71686904|NCT03441685|142890960|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.18||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.18
71686905|NCT03441685|142890961|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.56||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.56
71686906|NCT03441685|142890961|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.1||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.10
71686907|NCT03441685|142890961|OTHER|Accuracy labeling taught verbs in syntactic vs combined condition (expressive)||||||0.71||||||Asymptotic p-value|Wilcoxon Signed Ranks Test|||||||0.71
71686908|NCT03441685|142890961|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0|||||<|0.001||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||<.001
71686909|NCT03441685|142890961|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.024||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.024
71686910|NCT03441685|142890961|OTHER|One-sample Wilcoxon signed rank test with comparison value of 0||||||0.1||||||Asymptotic p-value|One-sample Wilcoxon signed rank test|||||||0.10
71686911|NCT02756819|142890996|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
71686912|NCT02756819|142890997|OTHER||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test|||||||<0.001
71686913|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
71686914|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
71686915|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
71686916|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
71686917|NCT02756819|142891000|OTHER||||||<|0.001|||||||Wilcoxon test|P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)||||||<0.001
71686918|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
71686919|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
71686920|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
71686921|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
71686922|NCT02756819|142891000|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
71686923|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test|||||||<0.001
71686924|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test|||||||<0.001
71686925|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test|||||||<0.001
71686926|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test|||||||<0.001
71686927|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|Wilcoxon test|||||||<0.001
71686928|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test|||||||<0.001
71686929|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test|||||||<0.001
71686930|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test|||||||<0.001
71686931|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test|||||||<0.001
71686932|NCT02756819|142891001|OTHER||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test|||||||<0.001
71879978|NCT04206605|143279320|SUPERIORITY||Risk Difference (RD)|-0.087|||=|0.25|TWO_SIDED|95.0|-0.28|0.063||P-value was from the corresponding Mantel-Haenszel estimate for the common risk difference from CMH test; unadjusted for multiple testing.|Cochran-Mantel-Haenszel|||||0.063|-0.280|=0.250
71686933|NCT00264290|142891004|OTHER|||||||0.007|||||||Fisher Exact|||||||0.007
71879979|NCT04206605|143279322|SUPERIORITY||Rate Ratio|0.97|||=|0.896|TWO_SIDED|95.0|0.58|1.61||P-value was from Wald-based chi-square test; unadjusted for multiple testing.|Chi-squared|||||1.61|0.58|=0.896
71879980|NCT04206605|143279324|SUPERIORITY||||||=|0.498||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.498
71879981|NCT04206605|143279325|SUPERIORITY||||||=|0.184||||||P-value comparing lanadelumab to placebo was from a log rank test stratified by baseline strata.|Log Rank|||||||=0.184
71920358|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.589|STANDARD_ERROR_OF_MEAN|3.73|<|0.001|TWO_SIDED|95.0|-43.999|-29.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.178|-43.999|<0.001
71920359|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.683|STANDARD_ERROR_OF_MEAN|3.734|<|0.001|TWO_SIDED|95.0|-62.102|-47.265|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.265|-62.102|<0.001
71686934|NCT03585712|142891038|OTHER|Is the overall mean change from baseline different from zero? Or did the infringement of schedule regardless the type of infringement lead to a change in mucus score?||||||0.26||||||P value from model testing intercept (does infringement change mucus score?) P-value from a repeated measures mixed model with the period, intervention, sequence and time (visit) as covariates. P-values ≤0.050 are considered significant|Mixed Models Analysis|||"Mixed model for repeated measures using as response delta to Day41, delta to Day42, delta to Day70 and delta to Day71.~Covariates: period, intervention (missed pill or delayed pill), sequence of intervention (missed pill then delayed pill and vice versa), time and subject.~Subject as random effect + time repeated effect within each combination subject\* period"||||0.26
71686935|NCT03585712|142891039|OTHER||||||>|0.999||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Absence of risk increase||||>0.999
71686936|NCT03585712|142891039|OTHER|||||||0.655||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Transient risk increase||||0.655
71686937|NCT03585712|142891039|OTHER|||||||0.317||||||p values \> 0.050 (Not Statistically significant)|McNemar|McNemar test comparing agreement in the missed and delayed periods||Prolonged risk increase||||0.317
71686938|NCT03585712|142891040|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
71686939|NCT03585712|142891040|OTHER||||||<|0.001||||||Indicates significance at the 0.05 level (p-value ≤ 0.05)|McNemar|P-value from an exact kappa test comparing agreement of ovarian status vs the reported perfect use period.||A stratified McNemar test (stratification on the site, AGREE option in SAS) was used to compare the distribution of ovarian activity classification in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use). The worst (meaning most risk of ovulation) ovarian activity category in the period was used for the analyses.||||<0.001
71686940|NCT03585712|142891041|OTHER|||||||0.127|||||||McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.127
71686941|NCT03585712|142891041|OTHER|||||||0.018||||||\* Indicates significance at the 0.05 level (p-value ≤ 0.05).|McNemar|P-value from an exact kappa test comparing agreement of cervical mucus score classification vs the reported perfect use period.||Stratified McNemar test (stratification on the site, AGREE option in SAS) to compare the distribution of cervical mucus scores in the perfect use period to the delayed and missed pill periods (pairwise vs perfect use).||||0.018
71686942|NCT04677387|142891055|SUPERIORITY||Mean Difference (Final Values)|-0.00325||||0.473|TWO_SIDED||||||Regression, Linear|Linear regression using a Generalized Estimating Equation (GEE) model clustering on pharmacy.||||||0.473
71879982|NCT04315181|143279333|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=6.89, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
71686943|NCT04677387|142891056|SUPERIORITY|||||||0.007|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||.007
71879983|NCT04315181|143279334|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=5.51, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
71879984|NCT04315181|143279335|SUPERIORITY|||||||0.138||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=1.61, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.138
71879985|NCT04315181|143279336|SUPERIORITY||||||<|0.0001||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=8.15, df=8, 72||Peak scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||<0.0001
71686944|NCT04677387|142891057|SUPERIORITY|||||||0.002|||||||Regression, Linear|Linear regression with a Generalized Estimating Equation (GEE) model.||||||.002
71686945|NCT04677387|142891058|SUPERIORITY|||||||0.169|||||||Regression, Linear|Linear regression with Generalized Estimating Equation (GEE) model.||||||0.169
71686946|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.4|1.2||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.2|-3.4|
71686947|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-3.7|1.6||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-3.7|
71879986|NCT04315181|143279337|SUPERIORITY|||||||0.0002||||||Statistical significance is 2-sided and accepted at a P value of ≤ 0.05.|Mixed Models Analysis|F=4.58, df=8, 72||Trough scores were calculated for individual participants within each dose condition and analyzed in a one-factor model (drug condition) with a compound symmetry covariance structure.||||0.0002
71882816|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1722|STANDARD_ERROR_OF_MEAN|0.2064||0.4083|TWO_SIDED|80.0|-0.4403|0.09599|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.09599|-0.4403|0.4083
71879987|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.48|||||TWO_SIDED|95.0|1.22|1.81|||||The analysis of covariance (ANCOVA) model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 1||1.81|1.22|
71879988|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.31|||||TWO_SIDED|95.0|1.12|1.54|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 3||1.54|1.12|
71879989|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.13|1.58|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 4||1.58|1.13|
71879990|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.08|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 5||1.71|1.08|
71879991|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.37|||||TWO_SIDED|95.0|1.12|1.69|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6A||1.69|1.12|
71879992|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.41|||||TWO_SIDED|95.0|1.17|1.7|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 6B||1.70|1.17|
71879993|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.16|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 7F||1.55|1.16|
71879994|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.38|||||TWO_SIDED|95.0|1.17|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 8||1.64|1.17|
71879995|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.24|||||TWO_SIDED|95.0|1.05|1.47|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 9V||1.47|1.05|
71879996|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.22|||||TWO_SIDED|95.0|1.03|1.44|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 10A||1.44|1.03|
71879997|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.18|||||TWO_SIDED|95.0|0.98|1.42|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 11A||1.42|0.98|
71879998|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.2|||||TWO_SIDED|95.0|0.99|1.46|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 12F||1.46|0.99|
71879999|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.42|||||TWO_SIDED|95.0|1.21|1.67|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 14||1.67|1.21|
71880000|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.46|||||TWO_SIDED|95.0|1.22|1.76|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 15B||1.76|1.22|
71882817|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2744|STANDARD_ERROR_OF_MEAN|0.1055||0.012|TWO_SIDED|80.0|0.13746|0.41127|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.41127|0.13746|0.0120
71880001|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.29|||||TWO_SIDED|95.0|1.07|1.55|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 18C||1.55|1.07|
71880002|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.39|||||TWO_SIDED|95.0|1.2|1.61|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19A||1.61|1.20|
71880003|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.33|||||TWO_SIDED|95.0|1.12|1.57|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 19F||1.57|1.12|
71880004|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.12|1.6|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 22F||1.60|1.12|
71880005|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.36|||||TWO_SIDED|95.0|1.09|1.71|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 23F||1.71|1.09|
71880006|NCT05879107|143279341|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio (as measured by the OP assay) between the Control group (at Day 31) versus Co-administration group (at Day 31) was \<=2.|GMT ratio|1.4|||||TWO_SIDED|95.0|1.2|1.64|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|Strep pneumoniae - serotype 33F||1.64|1.20|
71880007|NCT05879107|143279342|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-A neutralizing titer was \<=1.5.|GMT ratio|1.06|||||TWO_SIDED|95.0|0.94|1.2|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-A||1.20|0.94|
71880008|NCT05879107|143279343|NON_INFERIORITY|NI was to be demonstrated if the upper limit of the 2-sided 95% CI of the GMT ratio between the Control group (at Day 61) versus Co-administration group (at Day 31) for RSV-B neutralizing titer was \<=1.5.|GMT ratio|1.0|||||TWO_SIDED|95.0|0.89|1.13|||||The ANCOVA model, for logarithm-transformed titers, included the treatment group and age category at vaccination as fixed effects and the pre-dose log-10 titer as covariate.|RSV-B||1.13|0.89|
71880009|NCT03437564|143279401|EQUIVALENCE|The difference in the least square (LS) means between the formulations (dosing of one Vortioxetine 20 mg tablet - dosing of two Vortioxetine 10 mg tablets) and the two-sided 90% confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.996|||||TWO_SIDED|90.0|0.967|1.026|||ANOVA|||||1.026|0.967|
71880010|NCT03437564|143279402|EQUIVALENCE|The difference in the LS means between the formulations (dosing of one vortioxetine 20 mg tablet - dosing of two vortioxetine 10 mg tablets) and the two-sided 90% CI were provided using a crossover ANOVA model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.972|||||TWO_SIDED|90.0|0.937|1.008|||ANOVA|||||1.008|0.937|
71880011|NCT04037748|143279413|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|90.8|||||TWO_SIDED|90.0|86.3|95.6||||||||95.6|86.3|
71880012|NCT04037748|143279414|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|93.7|||||TWO_SIDED|90.0|88.2|99.5||||||||99.5|88.2|
71880013|NCT04037748|143279416|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|97.3|||||TWO_SIDED|90.0|94.7|100.0||||||||100.0|94.7|
71880014|NCT04037748|143279417|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|94.82|||||TWO_SIDED|90.0|92.0|97.8||||||||97.8|92.0|
71880015|NCT00942175|143279436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|||||TWO_SIDED|90.0|0.6106|0.8026|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8026|0.6106|
71880016|NCT00942175|143279436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.734|||||TWO_SIDED|90.0|0.6516|0.8269|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.8269|0.6516|
71880017|NCT00942175|143279436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5564|||||TWO_SIDED|90.0|0.4877|0.6347|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.6347|0.4877|
71880018|NCT00942175|143279436|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6783|||||TWO_SIDED|90.0|0.5063|0.9087|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9087|0.5063|
71880019|NCT00942175|143279437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8573|||||TWO_SIDED|90.0|0.802|0.9165|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9165|0.8020|
71880020|NCT00942175|143279437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9103|||||TWO_SIDED|90.0|0.8567|0.9672|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.9672|0.8567|
71880021|NCT00942175|143279437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6943|||||TWO_SIDED|90.0|0.6438|0.7487|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||0.7487|0.6438|
71880022|NCT00942175|143279437|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8389|||||TWO_SIDED|90.0|0.644|1.0928|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.|||1.0928|0.6440|
71880023|NCT00942175|143279438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.1016|||||TWO_SIDED|90.0|0.0348|8.1684|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||8.1684|0.0348|
71880024|NCT00942175|143279438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0474|||||TWO_SIDED|90.0|-0.8555|4.9503|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||4.9503|-0.8555|
71880025|NCT00942175|143279438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0407|||||TWO_SIDED|90.0|6.5219|15.5595|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.5595|6.5219|
71880026|NCT00942175|143279438|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.4437|||||TWO_SIDED|90.0|7.1791|15.7083|||||Included only participants with complete data for both regimens. Values are least squares mean difference.|||15.7083|7.1791|
71880027|NCT00942175|143279439|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.035
71880028|NCT00942175|143279439|SUPERIORITY_OR_OTHER|||||||0.445||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.445
71880029|NCT00942175|143279439|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
71880030|NCT00942175|143279439|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
71880031|NCT00942175|143279440|SUPERIORITY_OR_OTHER|||||||0.004||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.004
71880032|NCT00942175|143279440|SUPERIORITY_OR_OTHER|||||||0.148||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||0.148
71880033|NCT00942175|143279440|SUPERIORITY_OR_OTHER||||||<|0.001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<0.001
71880034|NCT00942175|143279440|SUPERIORITY_OR_OTHER||||||<|0.0001||90.0||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA|||||||<.0001
71880035|NCT00545064|143279452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.001||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 score = 7"||7.0|-0.6|0.001
71880036|NCT00545064|143279452|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.2|STANDARD_DEVIATION|20.2||0.097||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 = 0"||7.0|-0.6|0.097
71880037|NCT00545064|143279455|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = -4"||-10.7|-12.3|<0.001
71880038|NCT00545064|143279455|SUPERIORITY_OR_OTHER||Median Difference (Net)|-11.5|STANDARD_DEVIATION|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = 0"||-10.7|-12.3|<0.001
71880039|NCT00258674|143279457|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.307||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.307
71880040|NCT00258674|143279458|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.551||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.551
71686948|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-2.3|2.4||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-2.3|
71686949|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.4|2.8||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-5.4|
71686950|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||TWO_SIDED|97.5|-5.3|2.6||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.6|-5.3|
71686951|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.7|4.7||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.7|-4.7|
71686952|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-2.7|1.6||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.6|-2.7|
71686953|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||TWO_SIDED|97.5|-3.8|2.8||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-3.8|
71686954|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||TWO_SIDED|97.5|-4.3|2.5||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.5|-4.3|
71686955|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|1.2|||||TWO_SIDED|97.5|-1.6|4.5||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.5|-1.6|
71686956|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.8|||||TWO_SIDED|97.5|-1.6|3.6||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.6|-1.6|
71686957|NCT01964716|142891069|SUPERIORITY_OR_OTHER||percentage difference|-0.4|||||TWO_SIDED|97.5|-4.4|3.5||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan \& Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) - 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.||3.5|-4.4|
71686958|NCT01964716|142891069|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV - 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||TWO_SIDED|97.5|-4.3|4.4||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.4|-4.3|
71686959|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.22||||||Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.87|
71882818|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1016|STANDARD_ERROR_OF_MEAN|0.1136||0.375|TWO_SIDED|80.0|-0.0457|0.24881|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.24881|-0.0457|0.3750
71882819|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4367|STANDARD_ERROR_OF_MEAN|3.9301||0.9119|TWO_SIDED|80.0|-4.665|5.5387|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||5.5387|-4.665|0.9119
71882820|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3429|STANDARD_ERROR_OF_MEAN|4.1977||0.1367|TWO_SIDED|80.0|-11.79|-0.896|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.8960|-11.79|0.1367
71686960|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.79|||||TWO_SIDED|97.5|0.71|0.9||||||Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.90|0.71|
71686961|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.0|||||TWO_SIDED|97.5|0.86|1.18||||||Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.86|
71686962|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.85|1.19||||||Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.19|0.85|
71686963|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.86|1.22||||||Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.86|
71686964|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.06|||||TWO_SIDED|97.5|0.82|1.36||||||Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.36|0.82|
71686965|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.94|||||TWO_SIDED|97.5|0.82|1.08||||||Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.82|
71686966|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||TWO_SIDED|97.5|0.87|1.21||||||Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.21|0.87|
71686967|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.96|||||TWO_SIDED|97.5|0.75|1.24||||||Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.75|
71686968|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.28|||||TWO_SIDED|97.5|1.09|1.49||||||Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.49|1.09|
71880041|NCT00258674|143279459|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.927||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.927
71880042|NCT00258674|143279460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.308||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.308
71922459|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Perecent Difference|-3.4||||0.686|TWO_SIDED|95.0|-19.3|12.5|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.5|-19.3|0.686
71686969|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||TWO_SIDED|97.5|0.82|1.24||||||Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.24|0.82|
71686970|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.04|||||TWO_SIDED|97.5|0.85|1.26||||||Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.26|0.85|
71882821|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.0062|STANDARD_ERROR_OF_MEAN|3.1094||0.0595|TWO_SIDED|80.0|-10.05|-1.964|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.964|-10.05|0.0595
71882822|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0362|STANDARD_ERROR_OF_MEAN|3.3182||0.1356|TWO_SIDED|80.0|0.72505|9.3473|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.3473|0.72505|0.1356
71882823|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|5.1569|STANDARD_ERROR_OF_MEAN|16.2884||0.7528|TWO_SIDED|80.0|-15.99|26.303|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||26.303|-15.99|0.7528
71882824|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|67.7022|STANDARD_ERROR_OF_MEAN|17.4066||0.0003|TWO_SIDED|80.0|45.114|90.29|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||90.290|45.114|0.0003
71882825|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|2.8582|STANDARD_ERROR_OF_MEAN|2.6389||0.2837|TWO_SIDED|80.0|-0.567|6.2835|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||6.2835|-0.5670|0.2837
71882826|NCT00531752|143284710|SUPERIORITY_OR_OTHER||LS Mean Difference|12.9251|STANDARD_ERROR_OF_MEAN|2.8913|<|0.0001|TWO_SIDED|80.0|9.1761|16.674|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||16.674|9.1761|<0.0001
71882827|NCT00531752|143284711|SUPERIORITY_OR_OTHER||LS Mean Difference|26.8615|STANDARD_ERROR_OF_MEAN|3.9167|<|0.0001|TWO_SIDED|80.0|21.777|31.946|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||31.946|21.777|<0.0001
71882828|NCT00531752|143284711|SUPERIORITY_OR_OTHER||LS Mean Difference|4.3455|STANDARD_ERROR_OF_MEAN|4.1817||0.3034|TWO_SIDED|80.0|-1.08|9.7713|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.7713|-1.080|0.3034
71882829|NCT00531752|143284711|SUPERIORITY_OR_OTHER||LS Mean Difference|6.9558|STANDARD_ERROR_OF_MEAN|2.9408||0.0223|TWO_SIDED|80.0|3.132|10.78|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||10.780|3.1320|0.0223
71882830|NCT00531752|143284711|SUPERIORITY_OR_OTHER||LS Mean Difference|3.7518|STANDARD_ERROR_OF_MEAN|3.0743||0.2284|TWO_SIDED|80.0|-0.2442|7.7479|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||7.7479|-0.2442|0.2284
71882831|NCT00531752|143284711|SUPERIORITY_OR_OTHER||LS Mean Difference|8.5752|STANDARD_ERROR_OF_MEAN|3.5848||0.0201|TWO_SIDED|80.0|3.9265|13.224|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||13.224|3.9265|0.0201
71882832|NCT00531752|143284711|SUPERIORITY_OR_OTHER||LS Mean Difference|5.0229|STANDARD_ERROR_OF_MEAN|3.8154||0.1931|TWO_SIDED|80.0|0.07753|9.9683|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||9.9683|0.07753|0.1931
71882833|NCT00531752|143284712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6766|STANDARD_ERROR_OF_MEAN|0.1759||0.0003|TWO_SIDED|80.0|-0.9046|-0.4487|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.4487|-0.9046|0.0003
71882834|NCT00531752|143284712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3075|STANDARD_ERROR_OF_MEAN|0.1871||0.1055|TWO_SIDED|80.0|-0.5499|-0.065|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.0650|-0.5499|0.1055
71882835|NCT00531752|143284712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4684|STANDARD_ERROR_OF_MEAN|0.1791||0.0119|TWO_SIDED|80.0|-0.7012|-0.2356|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.2356|-0.7012|0.0119
71882836|NCT00531752|143284712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1263|STANDARD_ERROR_OF_MEAN|0.1866||0.5016|TWO_SIDED|80.0|-0.3687|0.11608|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.11608|-0.3687|0.5016
71882837|NCT00531752|143284712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3451|STANDARD_ERROR_OF_MEAN|0.1738||0.0531|TWO_SIDED|80.0|-0.5711|-0.1191|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1191|-0.5711|0.0531
71880043|NCT00258674|143279461|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.867||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.867
71880044|NCT00258674|143279462|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.807||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.807
71880045|NCT00258674|143279463|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.702||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.702
71880046|NCT00258674|143279464|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.413||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.413
71882838|NCT00531752|143284712|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4137|STANDARD_ERROR_OF_MEAN|0.1856||0.0306|TWO_SIDED|80.0|-0.6549|-0.1725|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.1725|-0.6549|0.0306
71882839|NCT00531752|143284713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7671|STANDARD_ERROR_OF_MEAN|0.1731|<|0.0001|TWO_SIDED|80.0|0.5426|0.99157|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.99157|0.54260|<0.0001
71882840|NCT00531752|143284713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5285|STANDARD_ERROR_OF_MEAN|0.1847||0.0059|TWO_SIDED|80.0|0.28911|0.76798|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.76798|0.28911|0.0059
71882841|NCT00531752|143284713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1526|STANDARD_ERROR_OF_MEAN|0.1431||0.2921|TWO_SIDED|80.0|-0.0336|0.33878|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.33878|-0.0336|0.2921
71882842|NCT00531752|143284713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.198|STANDARD_ERROR_OF_MEAN|0.1498||0.1929|TWO_SIDED|80.0|0.00319|0.39272|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.39272|0.00319|0.1929
71882843|NCT00531752|143284713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3433|STANDARD_ERROR_OF_MEAN|0.1565||0.0332|TWO_SIDED|80.0|0.13988|0.54663|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.54663|0.13988|0.0332
71882844|NCT00531752|143284713|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4184|STANDARD_ERROR_OF_MEAN|0.1681||0.0162|TWO_SIDED|80.0|0.20006|0.63674|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.63674|0.20006|0.0162
71882845|NCT00531752|143284714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5103|STANDARD_ERROR_OF_MEAN|0.1103|<|0.0001|TWO_SIDED|80.0|0.36707|0.65345|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.65345|0.36707|<0.0001
71882846|NCT00531752|143284714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3643|STANDARD_ERROR_OF_MEAN|0.1174||0.0031|TWO_SIDED|80.0|0.21189|0.51664|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.51664|0.21189|0.0031
71882847|NCT00531752|143284714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1362|STANDARD_ERROR_OF_MEAN|0.09408||0.1553|TWO_SIDED|80.0|0.01366|0.25882|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.25882|0.01366|0.1553
71880047|NCT00258674|143279465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.996||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.996
71880048|NCT00258674|143279466|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.02||||0.451||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.451
71880049|NCT00258674|143279467|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1||||0.447||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.447
71880050|NCT00258674|143279468|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.936||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.936
71880051|NCT00258674|143279469|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.04||||0.332||95.0||||A comparison of the claims vs. claims+MR arms was also conducted, giving a p-value of 0.537.|Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.332
71880052|NCT00258674|143279470|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.01||||0.86||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.860
71880053|NCT00258674|143279471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.382||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.382
71880054|NCT00258674|143279472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.988||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.988
71880055|NCT00258674|143279473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.685||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as -1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.||||0.685
71880056|NCT03715153|143279474|SUPERIORITY||Estimate of the adjusted difference|0.35|STANDARD_ERROR_OF_MEAN|0.71||0.617|TWO_SIDED|95.0|-1.04|1.75|||t-test, 2 sided|General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline.|Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.04|0.617
71880057|NCT03715153|143279475|SUPERIORITY||Estimate of the adjusted difference|0.48|STANDARD_ERROR_OF_MEAN|3.26|||TWO_SIDED|95.0|-5.91|6.88|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||6.88|-5.91|
71880058|NCT03715153|143279476|SUPERIORITY||Estimate of the adjusted difference|-0.04|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.24|0.16|||||Rank-based analysis (Wilcoxon scores) including terms for fixed categorical effects of treatment, country and gender. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||0.16|-0.24|
71880059|NCT03715153|143279477|SUPERIORITY||Estimate of the adjusted difference|0.16|STANDARD_ERROR_OF_MEAN|0.81|||TWO_SIDED|95.0|-1.42|1.75|||||General Linear Model including the fixed, categorical effects of treatment, country, gender, as well as the continuous, fixed covariates of baseline. Estimate of the adjusted difference was based on 211 patients (Missing data were imputed).|||1.75|-1.42|
71880060|NCT03715153|143279481|SUPERIORITY||Estimate of the adjusted difference|-0.26|STANDARD_ERROR_OF_MEAN|2.48|||TWO_SIDED|95.0|-5.12|4.59||||||||4.59|-5.12|
71880061|NCT01412554|143279566|OTHER|Only descriptive statistics|||||<|0.05|||||||Spearman|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient||Only an observational follow-up study|The degree of tracking was assessed by Spearman's rank or Pearson's correlation coefficient|||<0.05
71880062|NCT02012621|143279626|OTHER||Odds Ratio (OR)|73.5|||<|0.0001|TWO_SIDED|95.0|25.7|210.5|||Regression, Logistic|||||210.5|25.7|<0.0001
71880063|NCT02012621|143279627|OTHER||Odds Ratio (OR)|8.5||||0.0012|TWO_SIDED|95.0|2.3|30.9|||Regression, Logistic|||||30.9|2.3|0.0012
71880064|NCT02012621|143279628|OTHER||Odds Ratio (OR)|4.7|||<|0.0001|TWO_SIDED|95.0|2.6|8.7|||Regression, Logistic|||||8.7|2.6|<0.0001
71880065|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|2.4|||||TWO_SIDED|95.0|-6.4|11.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||11.2|-6.4|
71880066|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined||8.3|-10.8|
71880067|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|2.0|||||TWO_SIDED|95.0|-9.3|13.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||13.2|-9.3|
71880068|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-11.4|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1||11.4|-11.4|
71880069|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-14.8|||||TWO_SIDED|95.0|-29.2|-0.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||-0.3|-29.2|
71880070|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-7.0|||||TWO_SIDED|95.0|-20.9|6.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2||6.9|-20.9|
71880071|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-17.6|||||TWO_SIDED|95.0|-32.8|-2.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-2.4|-32.8|
71880072|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-19.0|||||TWO_SIDED|95.0|-34.1|-3.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3||-3.9|-34.1|
71880073|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
71880074|NCT02090413|143279633|SUPERIORITY_OR_OTHER||Difference in percentage|-4.8|||||TWO_SIDED|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4||11.4|-21.0|
71880075|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-2.6|12.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.4|-2.6|
71880076|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-2.5|12.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events||12.5|-2.5|
71880077|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|-1.5|||||TWO_SIDED|95.0|-11.2|8.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.1|-11.2|
71880078|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|-1.3|||||TWO_SIDED|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events||8.3|-10.8|
71880079|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|4.9|||||TWO_SIDED|95.0|-1.8|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.8|
71880080|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-1.7|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events||11.7|-1.7|
71880081|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|5.9|||||TWO_SIDED|95.0|-5.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||17.3|-5.4|
71880082|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|5.0|||||TWO_SIDED|95.0|-6.4|16.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events||16.4|-6.4|
71880083|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|-8.0|||||TWO_SIDED|95.0|-19.5|3.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||3.5|-19.5|
71880084|NCT02090413|143279634|SUPERIORITY_OR_OTHER||Difference in percentage|-11.3|||||TWO_SIDED|95.0|-23.1|0.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events||0.6|-23.1|
71880085|NCT02090413|143279637|SUPERIORITY_OR_OTHER||Difference in percentage|-1.4|||||TWO_SIDED|95.0|-15.8|13.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||13.0|-15.8|
71880086|NCT02090413|143279637|SUPERIORITY_OR_OTHER||Difference in percentage|5.4|||||TWO_SIDED|95.0|-8.4|19.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined||19.1|-8.4|
71880087|NCT02090413|143279637|SUPERIORITY_OR_OTHER||Difference in percentage|6.5|||||TWO_SIDED|95.0|-9.9|23.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||23.0|-9.9|
71880088|NCT02090413|143279637|SUPERIORITY_OR_OTHER||Difference in percentage|15.7|||||TWO_SIDED|95.0|0.2|31.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined||31.3|0.2|
71880089|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||15.4|-10.2|
71880090|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-8.6|16.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined||16.6|-8.6|
71880091|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|3.1|||||TWO_SIDED|95.0|-12.8|18.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||18.9|-12.8|
71880092|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|12.3|||||TWO_SIDED|95.0|-2.8|27.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined||27.3|-2.8|
71880093|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|-1.8|||||TWO_SIDED|95.0|-15.7|12.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||12.2|-15.7|
71880094|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|4.0|||||TWO_SIDED|95.0|-9.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined||17.3|-9.4|
71880095|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|-9.0|||||TWO_SIDED|95.0|-25.1|7.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||7.0|-25.1|
71880096|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|3.3|||||TWO_SIDED|95.0|-12.0|18.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined||18.5|-12.0|
71880097|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|-0.3|||||TWO_SIDED|95.0|-13.5|12.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||12.9|-13.5|
71880098|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|2.6|||||TWO_SIDED|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined||15.4|-10.2|
71880099|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|0.2|||||TWO_SIDED|95.0|-15.3|15.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||15.7|-15.3|
71880100|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|4.8|||||TWO_SIDED|95.0|-10.3|19.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined||19.9|-10.3|
71880101|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0|||||TWO_SIDED|95.0|-18.4|14.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||14.3|-18.4|
71880102|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|13.7|||||TWO_SIDED|95.0|-1.9|29.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined||29.3|-1.9|
71880103|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|-5.2|||||TWO_SIDED|95.0|-22.1|11.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||11.8|-22.1|
71880104|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|7.1|||||TWO_SIDED|95.0|-9.6|23.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined||23.9|-9.6|
71880105|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8 combined||25.5|-6.8|
71880106|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|9.4|||||TWO_SIDED|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8||25.5|-6.8|
71920360|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.517|STANDARD_ERROR_OF_MEAN|3.688|<|0.001|TWO_SIDED|95.0|-63.845|-49.189|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.189|-63.845|<0.001
71920361|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.262|STANDARD_ERROR_OF_MEAN|3.196|<|0.001|TWO_SIDED|95.0|-39.608|-26.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.915|-39.608|<0.001
71920362|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-45.956|STANDARD_ERROR_OF_MEAN|3.239|<|0.001|TWO_SIDED|95.0|-52.388|-39.523|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.523|-52.388|<0.001
71920363|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.5|STANDARD_ERROR_OF_MEAN|3.305|<|0.001|TWO_SIDED|95.0|-58.063|-44.937|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.937|-58.063|<0.001
71920364|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.474|STANDARD_ERROR_OF_MEAN|3.547|<|0.001|TWO_SIDED|95.0|-47.523|-33.426|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.426|-47.523|<0.001
71920365|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-54.634|STANDARD_ERROR_OF_MEAN|3.549|<|0.001|TWO_SIDED|95.0|-61.685|-47.583|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-47.583|-61.685|<0.001
71920366|NCT02055976|143362577|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.608|STANDARD_ERROR_OF_MEAN|3.52|<|0.001|TWO_SIDED|95.0|-66.602|-52.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.614|-66.602|<0.001
71920367|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.265|STANDARD_ERROR_OF_MEAN|3.566|<|0.001|TWO_SIDED|95.0|-50.347|-36.183|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.183|-50.347|<0.001
71920368|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.962|STANDARD_ERROR_OF_MEAN|3.628|<|0.001|TWO_SIDED|95.0|-65.167|-50.758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.758|-65.167|<0.001
71920369|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.729|STANDARD_ERROR_OF_MEAN|3.682|<|0.001|TWO_SIDED|95.0|-72.039|-57.419|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.419|-72.039|<0.001
71920370|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.428|STANDARD_ERROR_OF_MEAN|3.535|<|0.001|TWO_SIDED|95.0|-43.451|-29.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-29.405|-43.451|<0.001
71920371|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.296|STANDARD_ERROR_OF_MEAN|3.538|<|0.001|TWO_SIDED|95.0|-60.325|-46.267|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.267|-60.325|<0.001
71920372|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.489|STANDARD_ERROR_OF_MEAN|3.496|<|0.001|TWO_SIDED|95.0|-62.436|-48.542|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.542|-62.436|<0.001
71920373|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.288|STANDARD_ERROR_OF_MEAN|3.41|<|0.001|TWO_SIDED|95.0|-42.059|-28.516|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-28.516|-42.059|<0.001
71920374|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.845|STANDARD_ERROR_OF_MEAN|3.456|<|0.001|TWO_SIDED|95.0|-55.709|-41.982|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.982|-55.709|<0.001
71880107|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|3.8|||||TWO_SIDED|95.0|-13.2|20.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||20.8|-13.2|
71880108|NCT02090413|143279638|SUPERIORITY_OR_OTHER||Difference in percentage|8.4|||||TWO_SIDED|95.0|-8.5|25.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined||25.3|-8.5|
71880109|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.414|0.125|||||Analysis of variance model (ANCOVA) model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.125|-0.414|
71880110|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.392|||||TWO_SIDED|95.0|-0.656|-0.128|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||-0.128|-0.656|
71880111|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.247|||||TWO_SIDED|95.0|-0.507|0.012|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined||0.012|-0.507|
71880112|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.376|||||TWO_SIDED|95.0|-0.193|0.945|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.945|-0.193|
71880113|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|||||TWO_SIDED|95.0|-0.498|0.635|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.635|-0.498|
71880114|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.308|||||TWO_SIDED|95.0|-0.867|0.251|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined||0.251|-0.867|
71880115|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|||||TWO_SIDED|95.0|-0.308|0.355|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.355|-0.308|
71880116|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-0.374|0.254|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.254|-0.374|
71880117|NCT02090413|143279642|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|||||TWO_SIDED|95.0|-0.4|0.232|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined||0.232|-0.4|
71880118|NCT00487396|143279656|OTHER||||||<|0.0001|||||||McNemar|||"Pathologies were including in the analysis as follows:~* combination of CE+IC procedures but not detected by the combination of SBFT+IC procedures were marked as CE+IC new finding ;~* Pathologies detected by the combination of SBFT+IC procedures but not detected by the combination of CE+IC procedures were marked as SBFT+IC new finding event;~* Pathologies detected by the combination of CE+IC procedures and by the combination of SBFT+IC procedures were marked as same findings event."||||<0.0001
71880119|NCT00487396|143279657|OTHER||||||<|0.0001|||||||McNemar|||"For each category, the numbers of found and missed pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by SBFT procedure were marked as CE new finding event;~* Pathologies detected by SBFT procedure but not detected by CE procedure were marked as SBFT new finding event;~* Pathologies detected by both procedures (i.e., CE and SBFT) were marked as same findings event."||||<0.0001
71880120|NCT00487396|143279658|OTHER|||||||0.085|||||||McNemar|||"Pathologies were including in the analysis as follows:~* Pathologies detected by CE procedure but not detected by IC procedure were marked as CE new finding event;~* Pathologies detected by IC procedure but not detected by CE procedure were marked as IC new finding event;~* Pathologies detected by both procedures (i.e., CE and IC) were marked as same findings event."||||0.085
71880121|NCT05321069|143279660|SUPERIORITY||Mean Difference (Net)|44.89||||0.0222|TWO_SIDED|95.0|6.44|83.33|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 9 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||83.33|6.44|0.0222
71880122|NCT05321069|143279660|SUPERIORITY||Mean Difference (Net)|68.83||||0.0005|TWO_SIDED|95.0|30.26|107.39|||Mixed Models Analysis|The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.|Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 18 mg bid group and the Placebo group.|Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.||107.39|30.26|0.0005
71882848|NCT00531752|143284714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.107|STANDARD_ERROR_OF_MEAN|0.09797||0.2809|TWO_SIDED|80.0|-0.0205|0.23458|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.23458|-0.0205|0.2809
71920375|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.114|STANDARD_ERROR_OF_MEAN|3.526|<|0.001|TWO_SIDED|95.0|-62.116|-48.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.112|-62.116|<0.001
71920376|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.045|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-47.118|-32.971|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.971|-47.118|<0.001
71920377|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-53.81|STANDARD_ERROR_OF_MEAN|3.56|<|0.001|TWO_SIDED|95.0|-60.883|-46.737|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-46.737|-60.883|<0.001
71686971|NCT01964716|142891070|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.2|||||TWO_SIDED|97.5|0.98|1.48||||||Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.48|0.98|
71686972|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-7.7|||||TWO_SIDED|95.0|-17.2|1.9||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.9|-17.2|
71920378|NCT02055976|143362578|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-58.62|STANDARD_ERROR_OF_MEAN|3.533|<|0.001|TWO_SIDED|95.0|-65.64|-51.6|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-51.600|-65.640|<0.001
71880123|NCT05321069|143279661|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.5443|TWO_SIDED|95.0|0.69|1.22|||Regression, Cox|||The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment group, baseline antifibrotic therapy use, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (hemoglobin-corrected) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.||1.22|0.69|0.5443
71880124|NCT05321069|143279661|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9512|TWO_SIDED|95.0|0.75|1.31|||Regression, Cox|||Based on Cox proportional hazards model including treatment, baseline antifibrotic therapy, age, baseline Forced Vital Capacity (FVC) percent predicted, and baseline Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percent predicted (corrected for haemoglobin) as covariates. p-values not adjusted for multiplicity.||1.31|0.75|0.9512
71880125|NCT05321069|143279662|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.5583|TWO_SIDED|95.0|0.76|1.67|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.67|0.76|0.5583
71880126|NCT05321069|143279662|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5896|TWO_SIDED|95.0|0.75|1.65|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.65|0.75|0.5896
71880127|NCT05321069|143279663|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9038|TWO_SIDED|95.0|0.7|1.36|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.36|0.70|0.9038
71880128|NCT05321069|143279663|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.4687|TWO_SIDED|95.0|0.82|1.56|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.56|0.82|0.4687
71880129|NCT05321069|143279664|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.7695|TWO_SIDED|95.0|0.74|1.25|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.25|0.74|0.7695
71880130|NCT05321069|143279664|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2068|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.10|0.64|0.2068
71880131|NCT05321069|143279665|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.9251|TWO_SIDED|95.0|0.69|1.41|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.41|0.69|0.9251
71880132|NCT05321069|143279665|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.4988|TWO_SIDED|95.0|0.62|1.26|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.26|0.62|0.4988
71880133|NCT05321069|143279666|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9084|TWO_SIDED|95.0|0.6|1.76|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.76|0.60|0.9084
71880134|NCT05321069|143279666|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.4682|TWO_SIDED|95.0|0.46|1.43|||Regression, Cox|||Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.||1.43|0.46|0.4682
71880135|NCT05321069|143279667|SUPERIORITY||Mean Difference (Net)|-1.0||||0.3697|TWO_SIDED|95.0|-3.2|1.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 9mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.19|-3.20|0.3697
71882849|NCT00531752|143284714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2195|STANDARD_ERROR_OF_MEAN|0.1146||0.0603|TWO_SIDED|80.0|0.07101|0.36803|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.36803|0.07101|0.0603
71920379|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.896|STANDARD_ERROR_OF_MEAN|2.643|<|0.001|TWO_SIDED|95.0|3.646|14.145|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.145|3.646|<0.001
71920380|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.429|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|10.141|20.717|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||20.717|10.141|<0.001
71920381|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.321|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|6.959|17.683|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.683|6.959|<0.001
71920382|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.804|STANDARD_ERROR_OF_MEAN|3.041||0.014|TWO_SIDED|95.0|0.761|12.847|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.847|0.761|0.014
71920383|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.565|STANDARD_ERROR_OF_MEAN|3.023|<|0.001|TWO_SIDED|95.0|4.556|16.573|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.573|4.556|<0.001
71920384|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|12.895|STANDARD_ERROR_OF_MEAN|2.969|<|0.001|TWO_SIDED|95.0|6.993|18.796|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.796|6.993|<0.001
71920385|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.644|STANDARD_ERROR_OF_MEAN|3.266||0.005|TWO_SIDED|95.0|2.157|15.13|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.130|2.157|0.005
71920386|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|14.708|STANDARD_ERROR_OF_MEAN|3.272|<|0.001|TWO_SIDED|95.0|8.208|21.208|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.208|8.208|<0.001
71920387|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|11.168|STANDARD_ERROR_OF_MEAN|3.317|<|0.001|TWO_SIDED|95.0|4.58|17.757|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||17.757|4.580|<0.001
71920388|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.132|STANDARD_ERROR_OF_MEAN|2.609||0.001|TWO_SIDED|95.0|2.947|13.316|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.316|2.947|0.001
71920389|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.23|STANDARD_ERROR_OF_MEAN|2.592|<|0.001|TWO_SIDED|95.0|5.079|15.381|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.381|5.079|<0.001
71880136|NCT05321069|143279667|SUPERIORITY||Mean Difference (Net)|-0.63||||0.5734|TWO_SIDED|95.0|-2.83|1.57|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 18mg BID group and the Placebo group at Week 52.|The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.||1.57|-2.83|0.5734
71880137|NCT05321069|143279668|SUPERIORITY||Mean Difference (Net)|-0.1||||0.9442|TWO_SIDED|95.0|-2.98|2.77|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.77|-2.98|0.9442
71880138|NCT05321069|143279668|SUPERIORITY||Mean Difference (Net)|-0.59||||0.6862|TWO_SIDED|95.0|-3.47|2.28|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.28|-3.47|0.6862
71880139|NCT05321069|143279669|SUPERIORITY||Mean Difference (Net)|0.19||||0.8759|TWO_SIDED|95.0|-2.25|2.63|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 9 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.63|-2.25|0.8759
71880140|NCT05321069|143279669|SUPERIORITY||Mean Difference (Net)|0.43||||0.732|TWO_SIDED|95.0|-2.02|2.87|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 18 mg BID group and the Placebo group at Week 52.|The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.||2.87|-2.02|0.7320
71880141|NCT05321069|143279670|SUPERIORITY||Mean Difference (Net)|1.17||||0.028|TWO_SIDED|95.0|0.13|2.22|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 9 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.22|0.13|0.0280
71882850|NCT00531752|143284714|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4278|STANDARD_ERROR_OF_MEAN|0.1212||0.0008|TWO_SIDED|80.0|0.27079|0.58479|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||0.58479|0.27079|0.0008
71882851|NCT00531752|143284715|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.3264|STANDARD_ERROR_OF_MEAN|2.6944|<|0.0001|TWO_SIDED|80.0|-16.83|-9.828|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-9.828|-16.83|<0.0001
71882852|NCT00531752|143284715|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.126|STANDARD_ERROR_OF_MEAN|2.8841||0.0068|TWO_SIDED|80.0|-11.87|-4.382|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-4.382|-11.87|0.0068
71882853|NCT00531752|143284715|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.5341|STANDARD_ERROR_OF_MEAN|2.3172||0.1346|TWO_SIDED|80.0|-6.551|-0.5175|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.5175|-6.551|0.1346
71882854|NCT00531752|143284715|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0911|STANDARD_ERROR_OF_MEAN|2.4268||0.6552|TWO_SIDED|80.0|-2.067|4.2494|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||4.2494|-2.067|0.6552
71882855|NCT00531752|143284715|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2001|STANDARD_ERROR_OF_MEAN|1.7614||0.0765|TWO_SIDED|80.0|-5.494|-0.9063|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-0.9063|-5.494|0.0765
71882856|NCT00531752|143284715|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8781|STANDARD_ERROR_OF_MEAN|1.8976||0.0473|TWO_SIDED|80.0|-6.349|-1.407|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.||-1.407|-6.349|0.0473
71882857|NCT03449095|143284834|SUPERIORITY||||||<|0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANOVA|||||||<0.001
71880142|NCT05321069|143279670|SUPERIORITY||Mean Difference (Net)|1.73||||0.0013|TWO_SIDED|95.0|0.68|2.78|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 18 mg BID group and the placebo group at Week 52.|"Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate."||2.78|0.68|0.0013
71880143|NCT05321069|143279671|SUPERIORITY||Mean Difference (Net)|2.49||||0.0042|TWO_SIDED|95.0|0.79|4.19|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 9 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||4.19|0.79|0.0042
71880144|NCT05321069|143279671|SUPERIORITY||Mean Difference (Net)|1.67||||0.053|TWO_SIDED|95.0|-0.02|3.37|||Mixed Models Analysis||The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 18 mg BID group and the placebo group at Week 52.|"Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.~Baseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate."||3.37|-0.02|0.0530
71880145|NCT00736255|143279672|SUPERIORITY_OR_OTHER|||||||0.54|||||||Chi-squared|||"Null Hypothesis:LDX and NRT will not facilitate smoking cessation compared to NRT and placebo.~Alternate Hypothesis: LDX and NRT will facilitate smoking cessation compared to NRT and placebo.~This is a one tailed, proof of concept study so there is no formal power analysis, however if we see a signal for treatment effect, we would like to do further investigation by conducting a separate trial."||||0.54
71880146|NCT04036708|143279735|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|2.33||0.77|TWO_SIDED|95.0|-3.93|5.32||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||5.32|-3.93|.77
71880147|NCT04036708|143279735|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|2.44||0.9|TWO_SIDED|95.0|-5.14|4.54||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||4.54|-5.14|.90
71880148|NCT04036708|143279736|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|64.03|STANDARD_ERROR_OF_MEAN|24.55||0.01|TWO_SIDED|95.0|15.26|112.8||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||112.8|15.26|.01
71880149|NCT04036708|143279736|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-37.53|STANDARD_ERROR_OF_MEAN|24.86||0.13|TWO_SIDED|95.0|-86.92|11.85||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, the HOME score, and child's age and sex were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. The alternative hypothesis was that the means of two groups were not equal. Planned sample size of total 100 analyzed was determined by feasibility considerations for this exploratory developmental R21 study. With planned n=66 in MISC+WTM arm and n=34 in WTM only arm, the unadjusted effect size of 0.60 was detectable as statistically significant with power of 0.80 and 0.05 level of significance in two-tailed tests.||11.85|-86.92|.13
71880150|NCT04036708|143279737|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-1.76|STANDARD_ERROR_OF_MEAN|2.97||0.55|TWO_SIDED|95.0|-7.65|4.13||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||4.13|-7.65|.55
71920390|NCT02055976|143362580|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.767|STANDARD_ERROR_OF_MEAN|2.565||0.014|TWO_SIDED|95.0|0.67|10.864|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.864|0.670|0.014
71920391|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.079|STANDARD_ERROR_OF_MEAN|1.905|<|0.001|TWO_SIDED|95.0|2.296|9.863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.863|2.296|<0.001
71920392|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.786|STANDARD_ERROR_OF_MEAN|1.918|<|0.001|TWO_SIDED|95.0|6.976|14.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.597|6.976|<0.001
71920393|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.069|STANDARD_ERROR_OF_MEAN|1.945|<|0.001|TWO_SIDED|95.0|5.206|12.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.932|5.206|<0.001
71920394|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.859|STANDARD_ERROR_OF_MEAN|2.173||0.014|TWO_SIDED|95.0|0.541|9.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.178|0.541|0.014
71920395|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.331|STANDARD_ERROR_OF_MEAN|2.161|<|0.001|TWO_SIDED|95.0|3.037|11.624|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.624|3.037|<0.001
71920396|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.075|STANDARD_ERROR_OF_MEAN|2.122|<|0.001|TWO_SIDED|95.0|4.856|13.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.293|4.856|<0.001
71686973|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-1.2|||||TWO_SIDED|95.0|-4.4|1.1||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||1.1|-4.4|
71880151|NCT04036708|143279737|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-3.42|STANDARD_ERROR_OF_MEAN|3.05||0.26|TWO_SIDED|95.0|-9.48|2.63||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome and household material possessions were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.63|-9.48|.26
71880152|NCT04036708|143279738|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.16||0.32|TWO_SIDED|95.0|-0.48|0.16||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.16|-0.48|.32
71920397|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.936|STANDARD_ERROR_OF_MEAN|2.266||0.005|TWO_SIDED|95.0|1.435|10.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.437|1.435|0.005
71920398|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.213|STANDARD_ERROR_OF_MEAN|2.271|<|0.001|TWO_SIDED|95.0|5.702|14.724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.724|5.702|<0.001
71686974|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
71686975|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-2.4|||||TWO_SIDED|95.0|-10.6|5.7||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||5.7|-10.6|
71686976|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.8||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.8|-2.9|
71686977|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-4.5|4.6||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.6|-4.5|
71880153|NCT04036708|143279738|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|95.0|-0.72|-0.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.06|-0.72|.02
71880154|NCT04036708|143279739|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.2||0.06|TWO_SIDED|95.0|-0.78|0.01||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||0.01|-0.78|.06
71880155|NCT04036708|143279739|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.21||0.001|TWO_SIDED|95.0|-1.11|-0.28||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||-0.28|-1.11|.001
71880156|NCT04036708|143279740|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|1.05|STANDARD_ERROR_OF_MEAN|0.49||0.04|TWO_SIDED|95.0|0.07|2.03||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.03|0.07|.04
71880157|NCT04036708|143279740|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.51||0.07|TWO_SIDED|95.0|-0.08|1.96||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||1.96|-0.08|.07
71880158|NCT04036708|143279741|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 6 in linear mixed effects model.|Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|0.51|<|0.01|TWO_SIDED|95.0|1.02|3.06||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||3.06|1.02|<.01
71880159|NCT04036708|143279741|SUPERIORITY|The key parameter was the coefficient for the trial arm difference at month 12 in linear mixed effects model.|Mean Difference (Final Values)|1.73|STANDARD_ERROR_OF_MEAN|0.53|<|0.01|TWO_SIDED|95.0|0.67|2.79||P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was .05.|Mixed Models Analysis|Baseline value of the outcome, household material possessions, and the HOME score were adjusted for in the model.|WTM only minus MISC and WTM|The null hypothesis was that the means of two groups were equal. Sample size was determined by considerations for the primary outcomes.||2.79|0.67|<.01
71880160|NCT02933034|143279764|OTHER|||||||0.001|||||||t-test, 2 sided|||Comparison of infarct size using MEMRI versus DEMRI scan||||0.001
71880161|NCT01648790|143279801|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.983|||||TWO_SIDED|90.0|0.819|1.18|||||Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.18|0.819|
71880162|NCT01648790|143279802|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.987|||||TWO_SIDED|90.0|0.918|1.06|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||1.06|0.918|
71920399|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.056|STANDARD_ERROR_OF_MEAN|2.302|<|0.001|TWO_SIDED|95.0|3.484|12.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.629|3.484|<0.001
71920400|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.846|STANDARD_ERROR_OF_MEAN|1.778|<|0.001|TWO_SIDED|95.0|2.312|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|2.312|<0.001
71686978|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.3|2.3||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.3|-2.3|
71880163|NCT01648790|143279803|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.28|||||TWO_SIDED|90.0|0.233|0.335|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.335|0.233|
71880164|NCT01648790|143279804|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.779|||||TWO_SIDED|90.0|0.724|0.837|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.|||0.837|0.724|
71880165|NCT01486927|143279810|SUPERIORITY_OR_OTHER||Rate ratio|0.08|||<|0.0001|TWO_SIDED|95.0|0.07|0.1|||Poisson, regression|||A test of the null hypothesis of no difference on AsBR between the 2 comparison groups was based on the Poisson Regression method. The corresponding prophylaxis/on-demand ratio with 95% confidence interval (CI) was calculated.||0.10|0.07|< 0.0001
71880166|NCT00365456|143279830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.012|STANDARD_ERROR_OF_MEAN|1.0045||0.01|TWO_SIDED|95.0|1.003|1.021||No multiplicity correction of the significance level was performed as only one primary endpoint was planned.|ANCOVA|Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.||An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.||1.021|1.003|0.010
71880167|NCT01476475|143279832|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority of insulin glargine/lixisenatide FRC versus insulin glargine was tested first, at alpha level of 0.025 (1-sided) and a non-inferiority margin of 0.4% HbA1c. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided). The non-inferiority was assessed using upper bound of 2-sided 95% confidence interval (CI) at ≤0.4%.|Least square (LS) mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|95.0|-0.312|-0.037|||ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. A step-down testing procedure described by Hochberg and Tamhane was used to control type-1 error.||-0.037|-0.312|
71880168|NCT01476475|143279832|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.07||0.013|TWO_SIDED|95.0|-0.312|-0.037||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline HbA1c value as covariates. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided).||-0.037|-0.312|0.0130
71880169|NCT01476475|143279833|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.17|STANDARD_ERROR_OF_MEAN|0.337|<|0.0001|TWO_SIDED|95.0|-3.832|-2.504||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA with treatment groups,randomization strata of screening HbA1c(\<8.0, ≥8.0%)\& screening BMI(\<30 kg/m\^2, ≥30 kg/m\^2),country as fixed effects and baseline 2-hour PPG value as covariates.A step-down testing procedure used to control type-1 error.If non-inferiority demonstrated for primary endpoint,superiority testing on secondary endpoints was performed sequentially in order endpoints are reported(continued only if previous endpoint was statistically significant).||-2.504|-3.832|<0.0001
71880170|NCT01476475|143279834|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|0.331|<|0.0001|TWO_SIDED|95.0|-3.895|-2.592||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline 2-hour plasma glucose excursion value as covariates.||-2.592|-3.895|<0.0001
71880171|NCT01476475|143279835|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.125||0.0154|TWO_SIDED|95.0|-0.55|-0.058||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline average 7-point SMPG value as covariates.||-0.058|-0.550|0.0154
71880172|NCT01476475|143279836|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.11|-0.773||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects and baseline body weight value as covariates.||-0.773|-2.110|<0.0001
71880173|NCT01476475|143279837|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.24|STANDARD_ERROR_OF_MEAN|1.704||0.0583|TWO_SIDED|95.0|-6.592|0.114||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (\<8.0, ≥8.0%), randomization strata of screening BMI (\<30 kg/m\^2, ≥30 kg/m\^2), and country as fixed effects.||0.114|-6.592|0.0583
71880174|NCT01278745|143279846|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|||||||ANCOVA|Adjusted for baseline PAV||||||0.0019
71880175|NCT01265615|143279859|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880176|NCT01265615|143279860|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880177|NCT01265615|143279861|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880178|NCT01265615|143279862|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880179|NCT01265615|143279863|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880180|NCT01265615|143279864|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880181|NCT01265615|143279865|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880182|NCT01265615|143279866|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880183|NCT01265615|143279867|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880184|NCT01265615|143279868|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71880185|NCT02953340|143279881|NON_INFERIORITY|The study used non inferiority margin of 0.62 days for the above comparison. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean difference|-0.074|||<|0.0001|TWO_SIDED|95.0|-0.292|0.129|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||0.129|-0.292|< 0.0001
71880186|NCT01977599|143279905|OTHER|Chi Square|||||<|0.001|||||||Chi-squared|||||||<0.001
71880187|NCT02375724|143279938|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.02||||0.0306|TWO_SIDED|95.0|-1.94|-0.1|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||-0.10|-1.94|0.0306
71880188|NCT02375724|143279939|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.22||||0.0793|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.03|-0.46|0.0793
71880189|NCT02375724|143279940|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.06||||0.844|TWO_SIDED|95.0|-0.64|0.52|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors||||0.52|-0.64|0.844
71880190|NCT02684604|143279941|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71880191|NCT01197521|143279944|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.08|<0.001
71880192|NCT01197521|143279944|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.1||||0.006|TWO_SIDED|95.0|0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.18|0.03|0.006
71880193|NCT01197521|143279945|SUPERIORITY_OR_OTHER|||||||0.252||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.252
71880194|NCT01197521|143279945|SUPERIORITY_OR_OTHER|||||||0.17||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.||||0.170
71880195|NCT01197521|143279946|SUPERIORITY_OR_OTHER||Weighted difference in proportion|0.13|||<|0.001|TWO_SIDED|95.0|0.1|0.17||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.17|0.10|<0.001
71880196|NCT01197521|143279947|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.16|||<|0.001|TWO_SIDED|95.0|0.11|0.22||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.22|0.11|<0.001
71880197|NCT01197521|143279947|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.09||||0.002|TWO_SIDED|95.0|0.03|0.14||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.14|0.03|0.002
71880198|NCT01197521|143279948|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.08|||<|0.001|TWO_SIDED|95.0|0.05|0.12||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.12|0.05|<0.001
71882858|NCT03449095|143284835|SUPERIORITY|||||||0.001||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|ANCOVA|||||||.001
71882859|NCT00609791|143284873|SUPERIORITY||Slope|0.011|STANDARD_ERROR_OF_MEAN|0.0057||0.055|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on age in years||||0.055
71882860|NCT00609791|143284873|SUPERIORITY||Slope|1.17|STANDARD_ERROR_OF_MEAN|0.45||0.013|TWO_SIDED||||||Regression, Linear|||Linear regression of ln AUC24 on chemotherapy toxicity risk score||||0.013
71686979|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|4.7|||||TWO_SIDED|95.0|-4.5|14.1||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||14.1|-4.5|
71686980|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-7.8|||||TWO_SIDED|95.0|-15.8|0.0||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||-0.0|-15.8|
71686981|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|0.0|||||TWO_SIDED|95.0|-2.9|2.9||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.9|-2.9|
71686982|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-1.9|||||TWO_SIDED|95.0|-6.6|2.4||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||2.4|-6.6|
71686983|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-0.7|||||TWO_SIDED|95.0|-6.3|4.9||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||4.9|-6.3|
71686984|NCT01964716|142891079|SUPERIORITY_OR_OTHER||percent difference|-1.3|||||TWO_SIDED|95.0|-5.8|3.0||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV - 13vPnC SDS, expressed as a percentage was analyzed.||3.0|-5.8|
71686985|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.2||||||Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.20|0.70|
71686986|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.69|0.93||||||Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||0.93|0.69|
71686987|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.39||||||Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.39|0.89|
71686988|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.22||||||Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.22|0.80|
71686989|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.7|1.06||||||Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.06|0.70|
71882861|NCT00609791|143284874|SUPERIORITY||Slope|-0.0074|STANDARD_ERROR_OF_MEAN|0.0063||0.25|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL on age in years||||0.25
71882862|NCT00609791|143284874|SUPERIORITY||Slope|-0.96|STANDARD_ERROR_OF_MEAN|0.44||0.04|TWO_SIDED||||||Regression, Linear|||Linear regression of ln CL versus chemotherapy toxicity risk score||||0.04
71882863|NCT00609791|143284875|OTHER|||||||0.041|||||||Fisher Exact|||||||0.041
71882864|NCT00609791|143284878|SUPERIORITY||Mean Difference (Final Values)|-4.89||||0.38|TWO_SIDED|95.0|-16.5|6.7|||t-test, 2 sided|||Difference in age based on whether there was need for a dose reduction.||6.7|-16.5|.38
71882865|NCT00609791|143284878|SUPERIORITY||Mean Difference (Final Values)|0.058||||0.76|TWO_SIDED|95.0|-0.33|0.44|||t-test, 2 sided|||Difference in AUC24 based on the need of a dose reduction.||0.44|-0.33|0.76
71882866|NCT00609791|143284878|SUPERIORITY||Mean Difference (Final Values)|-0.063||||0.75|TWO_SIDED|95.0|-0.49|0.36|||t-test, 2 sided|||Difference in clearance based on whether there was a need for dose reduction.||0.36|-0.49|0.75
71882867|NCT00609791|143284879|SUPERIORITY||Mean Difference (Final Values)|5.81||||0.15|TWO_SIDED|95.0|-2.3|13.9|||t-test, 2 sided|||Difference in age based on whether there was need for a dose omission.||13.9|-2.3|0.15
71882868|NCT00609791|143284879|SUPERIORITY||Mean Difference (Final Values)|-0.079||||0.61|TWO_SIDED|95.0|-0.39|0.23|||t-test, 2 sided|||Difference in AUC24 based on whether there was need for a dose omission.||0.23|-0.39|0.61
71882869|NCT00609791|143284879|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.51|TWO_SIDED|95.0|-0.22|0.42|||t-test, 2 sided|||Difference in clearance based on whether there was a need for a dose omission.||0.42|-0.22|0.51
71882870|NCT00609791|143284880|SUPERIORITY||Mean Difference (Final Values)|1.68||||0.75|TWO_SIDED|95.0|-9.3|12.7|||t-test, 2 sided|||Difference in age based on whether a participant experienced grade 3 toxicity.||12.7|-9.3|0.75
71882871|NCT00609791|143284880|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.13|TWO_SIDED|95.0|-0.12|0.81|||t-test, 2 sided|||Difference in AUC based on whether a participant experienced grade 3 toxicity.||0.81|-0.12|0.13
71920401|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.91|STANDARD_ERROR_OF_MEAN|1.766|<|0.001|TWO_SIDED|95.0|3.4|10.421|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.421|3.400|<0.001
71686990|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.74|1.33||||||Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.33|0.74|
71686991|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.8|||||TWO_SIDED|95.0|0.7|1.0||||||Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.00|0.70|
71686992|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|1.0|||||TWO_SIDED|95.0|0.79|1.27||||||Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.27|0.79|
71686993|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.7|||||TWO_SIDED|95.0|0.48|1.08||||||Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.08|0.48|
71686994|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.38|2.19||||||Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||2.19|1.38|
71686995|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.74|1.16||||||Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.16|0.74|
71686996|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.71|1.18||||||Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.18|0.71|
71686997|NCT01964716|142891080|SUPERIORITY_OR_OTHER||GMT Ratio|0.9|||||TWO_SIDED|95.0|0.67|1.25||||||Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV - 13vPnC SDS).||1.25|0.67|
71686998|NCT01215435|142891136|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.|Estimated treatment difference, Mean|-0.14|||<|0.001||95.0|-0.4|0.13|||Regression, Linear|||H0: D \> 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)||0.13|-0.40|<0.001
71686999|NCT01215435|142891137|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|-3.14||||0.6215||95.0|-15.65|9.37|||Regression, Linear|||||9.37|-15.65|0.6215
71687000|NCT05811026|142891139|SUPERIORITY||Median Difference (Net)|5.0||||0.075|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.075
71687001|NCT05811026|142891140|SUPERIORITY||Median Difference (Net)|0.17||||0.4727|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4727
71687002|NCT05811026|142891141|SUPERIORITY||Median Difference (Net)|-1.5||||0.7326|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.7326
71687003|NCT05811026|142891142|SUPERIORITY||Median Difference (Net)|0.61||||0.0757|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0757
71687004|NCT05811026|142891143|SUPERIORITY||Median Difference (Net)|37.75||||0.0376|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0376
71687005|NCT05811026|142891144|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.3123|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3123
71687006|NCT05811026|142891145|SUPERIORITY||Median Difference (Final Values)|1.0||||0.1009|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.1009
71687007|NCT05811026|142891146|SUPERIORITY||Mean Difference (Net)|5.5||||0.0088|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0088
71920402|NCT02055976|143362581|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.168|STANDARD_ERROR_OF_MEAN|1.748||0.01|TWO_SIDED|95.0|0.693|7.642|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.642|0.693|0.010
71687008|NCT05811026|142891147|SUPERIORITY||Median Difference (Net)|-0.03||||0.4274|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.4274
71687009|NCT05811026|142891148|SUPERIORITY||Mean Difference (Net)|1.75||||0.6497|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6497
71687010|NCT05811026|142891149|SUPERIORITY||Median Difference (Net)|0.54||||0.0006|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0006
71687011|NCT05811026|142891150|SUPERIORITY||Median Difference (Net)|34.5||||0.0002|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0002
71687012|NCT05811026|142891151|SUPERIORITY||Median Difference (Final Values)|0.0||||0.6231|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6231
71687013|NCT05811026|142891152|SUPERIORITY||Median Difference (Final Values)|0.0||||0.3327|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.3327
71687014|NCT05811026|142891153|SUPERIORITY||Median Difference (Net)|7.25||||0.0752|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0752
71687015|NCT05811026|142891154|SUPERIORITY||Median Difference (Net)|-0.94||||0.0982|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0982
71687016|NCT05811026|142891155|SUPERIORITY||Median Difference (Net)|-0.5||||0.8541|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.8541
71687017|NCT05811026|142891156|SUPERIORITY||Median Difference (Net)|0.63||||0.0758|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0758
71880199|NCT01197521|143279948|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.04||||0.015|TWO_SIDED|95.0|0.01|0.07||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||0.07|0.01|0.015
71880200|NCT01197521|143279949|SUPERIORITY_OR_OTHER||||||<|0.001||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||<0.001
71687018|NCT05811026|142891157|SUPERIORITY||Median Difference (Net)|41.75||||0.066|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.066
71880201|NCT01197521|143279949|SUPERIORITY_OR_OTHER|||||||0.002||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||||0.002
71687019|NCT05811026|142891158|SUPERIORITY||Median Difference (Final Values)|-0.17||||0.6961|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.6961
71687020|NCT05811026|142891159|SUPERIORITY||Median Difference (Final Values)|1.0||||0.0067|TWO_SIDED|||||Statistical significance was defined as a p-value \< 0.05.|Wilcoxon (Mann-Whitney)||Differece = (2-week interval group) - (4-week interval group)|||||0.0067
71687021|NCT02870205|142891161|SUPERIORITY||||||<|0.001||||||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|ANCOVA|||||||<0.001
71687022|NCT02870205|142891161|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
71687023|NCT02870205|142891161|SUPERIORITY|||||||0.019|||||||ANCOVA|||||||0.019
71687024|NCT02870205|142891161|SUPERIORITY||||||<|0.001|||||||ANCOVA|||||||<0.001
71687025|NCT02870205|142891161|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71687026|NCT02179749|142891198|SUPERIORITY||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|0.2||0.51|TWO_SIDED||||||ANOVA|||||||0.51
71687027|NCT02179749|142891198|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04||0.038|TWO_SIDED||||||Mixed Models Analysis|||Latent growth model includes one week on study drug and two weeks after the last dose of study drug. Principal predictors were drug plasma concentration and baseline treatment goal of abstinence or non abstinence. Arms were combined for this analysis.||||0.038
71687028|NCT02179749|142891199|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|36.7||0.5|TWO_SIDED||||||ANOVA|411 and 102 degrees of freedom||||||0.50
71687029|NCT02756364|142891200|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.537|TWO_SIDED|95.0|0.47|1.26|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original interactive response technology (IRT) stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.26|0.47|0.537
71880202|NCT01197521|143279950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0|||<|0.001|TWO_SIDED|95.0|2.44|14.64||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||14.64|2.44|<0.001
71880203|NCT01197521|143279950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.4||||0.002|TWO_SIDED|95.0|1.76|11.02||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||11.02|1.76|0.002
71880204|NCT01197521|143279951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.0|||<|0.001|TWO_SIDED|95.0|1.63|5.67||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||5.67|1.63|<0.001
71880205|NCT01197521|143279951|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.083|TWO_SIDED|95.0|0.93|3.5||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.50|0.93|0.083
71880206|NCT01197521|143279952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.79|3.3||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.30|1.79|<0.001
71880207|NCT01197521|143279952|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.57||||0.004|TWO_SIDED|95.0|1.16|2.14||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.14|1.16|0.004
71880208|NCT01197521|143279953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.001|TWO_SIDED|95.0|1.68|3.26||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.26|1.68|<0.001
71880209|NCT01197521|143279953|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9|||<|0.001|TWO_SIDED|95.0|1.38|2.68||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.68|1.38|<0.001
71880210|NCT01197521|143279954|SUPERIORITY_OR_OTHER||Treatment difference|2.24|||<|0.001||95.0|1.16|3.31||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.31|1.16|<0.001
71880211|NCT01197521|143279954|SUPERIORITY_OR_OTHER||Treatment difference|1.27||||0.02||95.0|0.2|2.35||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.35|0.20|0.020
71882872|NCT00609791|143284880|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.34|TWO_SIDED|95.0|-0.67|0.25|||t-test, 2 sided|||Difference in clearance based on whether a participant experienced grade 3 toxicity.||0.25|-0.67|0.34
71882873|NCT02484911|143284881|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
71882874|NCT02484911|143284882|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
71687030|NCT02756364|142891200|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.849|TWO_SIDED|95.0|0.53|1.45|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.45|0.53|0.849
71687031|NCT02756364|142891201|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.276|TWO_SIDED|95.0|0.36|1.4|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.40|0.36|0.276
71687032|NCT02756364|142891201|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.47|TWO_SIDED|95.0|0.47|1.68|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.68|0.47|0.470
71687033|NCT02756364|142891202|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.495|TWO_SIDED|95.0|0.46|1.25|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.25|0.46|0.495
71687034|NCT02756364|142891202|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.646|TWO_SIDED|95.0|0.49|1.38|||Log Rank||HR obtained by stratified Cox proportional hazard model with treatment arm, original IRT stratification factors as covariates. A hazard ratio of \<1 was considered statistically significant.|||1.38|0.49|0.646
71687035|NCT02756364|142891203|SUPERIORITY||Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.68|7.29|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||7.29|0.68|
71687036|NCT02756364|142891203|SUPERIORITY||Odds Ratio (OR)|1.22|||||TWO_SIDED|95.0|0.34|4.39|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.39|0.34|
71687037|NCT02756364|142891204|SUPERIORITY||Odds Ratio (OR)|2.56|||||TWO_SIDED|95.0|0.94|6.94|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||6.94|0.94|
71687038|NCT02756364|142891204|SUPERIORITY||Odds Ratio (OR)|1.75|||||TWO_SIDED|95.0|0.69|4.44|||||The odds ratio and 95% CIs were obtained using a stratified Cochran-Mantel-Haenszel model with the original IRT stratification factors (visceral metastases, previous sensitivity to hormonal therapy, and previous exposure to CDK4/6 inhibitors).|||4.44|0.69|
71687039|NCT02655016|142891206|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.502|0.755||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and homologous recombination deficiency (HRD) status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.755|0.502|<0.0001
71687040|NCT02655016|142891207|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.1238|TWO_SIDED|95.0|0.442|1.106||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.106|0.442|0.1238
71687041|NCT02655016|142891208|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0001|TWO_SIDED|95.0|0.521|0.802||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||0.802|0.521|0.0001
71687042|NCT02655016|142891209|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.2242|TWO_SIDED|95.0|0.577|1.139||p-value was calculated based on stratified log-rank test using randomization stratification factors: administration of neoadjuvant chemotherapy, best response to platinum therapy and HRD status.|Log Rank||If hazard ratio was found to be \<1 then niraparib can be considered as superior to placebo.|||1.139|0.577|0.2242
71687043|NCT02223364|142891221|SUPERIORITY|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||||||0.144
71687044|NCT02223364|142891221|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||||||0.016
71687045|NCT02223364|142891221|SUPERIORITY|||||||0.196|||||||Wilcoxon (Mann-Whitney)|||||||0.196
71687046|NCT02223364|142891222|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71687047|NCT02223364|142891222|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71687048|NCT02223364|142891222|SUPERIORITY|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||||||0.021
71687049|NCT02223364|142891223|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71687050|NCT02223364|142891223|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71687051|NCT02223364|142891223|SUPERIORITY|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||||||0.257
71687052|NCT02223364|142891224|SUPERIORITY|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||||||0.059
71687053|NCT02223364|142891224|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71687054|NCT02223364|142891224|SUPERIORITY|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||||||0.214
71687055|NCT02223364|142891225|SUPERIORITY|||||||0.189|||||||Wilcoxon (Mann-Whitney)|||||||0.189
71687056|NCT02223364|142891225|SUPERIORITY|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||||||0.043
71687057|NCT02223364|142891225|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
71687058|NCT02223364|142891226|SUPERIORITY|||||||0.958|||||||Wilcoxon (Mann-Whitney)|||||||0.958
71687059|NCT02223364|142891226|SUPERIORITY|||||||0.203|||||||Wilcoxon (Mann-Whitney)|||||||0.203
71687060|NCT02223364|142891226|SUPERIORITY|||||||0.132|||||||Wilcoxon (Mann-Whitney)|||||||0.132
71687061|NCT02223364|142891227|SUPERIORITY|||||||0.493|||||||Wilcoxon (Mann-Whitney)|||||||0.493
71687062|NCT02223364|142891227|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
71687063|NCT02223364|142891227|SUPERIORITY|||||||0.797|||||||Wilcoxon (Mann-Whitney)|||||||0.797
71687064|NCT02223364|142891228|SUPERIORITY|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||||||0.571
71687065|NCT02223364|142891228|SUPERIORITY|||||||0.991|||||||Wilcoxon (Mann-Whitney)|||||||0.991
71687066|NCT02223364|142891228|SUPERIORITY|||||||0.496|||||||Wilcoxon (Mann-Whitney)|||||||0.496
71687067|NCT02223364|142891229|SUPERIORITY|||||||0.807|||||||Wilcoxon (Mann-Whitney)|||||||0.807
71687068|NCT02223364|142891229|SUPERIORITY|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||||||0.171
71687069|NCT02223364|142891229|SUPERIORITY|||||||0.104|||||||Wilcoxon (Mann-Whitney)|||||||0.104
71687070|NCT02223364|142891231|SUPERIORITY|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||||||0.012
71687071|NCT02223364|142891231|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71687072|NCT02223364|142891231|SUPERIORITY|||||||0.293|||||||Wilcoxon (Mann-Whitney)|||||||0.293
71687073|NCT02223364|142891232|SUPERIORITY|||||||0.202|||||||Wilcoxon (Mann-Whitney)|||||||0.202
71687074|NCT02223364|142891232|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||||||0.007
71687075|NCT02223364|142891232|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
71687076|NCT02223364|142891233|SUPERIORITY|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||||||0.933
71687077|NCT02223364|142891233|SUPERIORITY|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
71687078|NCT02223364|142891233|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
71687079|NCT02223364|142891234|SUPERIORITY|||||||0.768|||||||Kruskal-Wallis|||||||0.768
71687080|NCT02223364|142891235|SUPERIORITY|||||||0.623|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.623
71687081|NCT02223364|142891235|SUPERIORITY|||||||0.001|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)||||0.001
71687082|NCT02223364|142891235|SUPERIORITY|||||||0.048|||||||Regression, Cox|||Within group comparison of baseline and three months (approximately 12 weeks)||||0.048
71687083|NCT01249833|142891308|SUPERIORITY_OR_OTHER||LS Means Difference|-30.4||||0.0492|TWO_SIDED|95.0|-60.7|-0.1|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||-0.1|-60.7|.0492
71687084|NCT01249833|142891309|SUPERIORITY_OR_OTHER||LS Means Difference|3.8||||0.0054|TWO_SIDED|95.0|1.14|6.42|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||6.42|1.14|0.0054
71687085|NCT01249833|142891310|SUPERIORITY_OR_OTHER||LS Means Difference|3.9||||0.9685|TWO_SIDED|95.0|-190.1|197.9|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|||197.9|-190.1|.9685
71687086|NCT01249833|142891311|SUPERIORITY_OR_OTHER||LS Means Difference|1.9||||0.3195|TWO_SIDED|95.0|-1.9|5.7|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|Alertness: the higher the value, the greater the alertness.||5.7|-1.9|.3195
71687087|NCT01249833|142891311|SUPERIORITY_OR_OTHER||LS Means Difference|-0.6||||0.7219|TWO_SIDED|95.0|-4.1|2.9|||ANCOVA||The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.|Calmness: the higher the value, the greater the calmness.||2.9|-4.1|.7219
71687088|NCT01249833|142891311|SUPERIORITY_OR_OTHER||LS Means Difference|3.3||||0.1162|TWO_SIDED|95.0|-0.8|7.4|||ANCOVA||The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.|Contentedness: the higher the value, the greater the contentedness.||7.4|-.8|.1162
71687089|NCT03796676|142891312|SUPERIORITY||Estimate of difference|16.7||||0.0147|TWO_SIDED|95.0|3.5|29.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||29.9|3.5|0.0147
71880212|NCT01197521|143279955|SUPERIORITY_OR_OTHER||Treatment difference|1.8||||0.005||95.0|0.54|3.07||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||3.07|0.54|0.005
71880213|NCT01197521|143279955|SUPERIORITY_OR_OTHER||Treatment difference|1.56||||0.017||95.0|0.28|2.83||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.||2.83|0.28|0.017
71882875|NCT02484911|143284884|SUPERIORITY_OR_OTHER|||||||0.397|||||||Chi-squared|||||||0.397
71687090|NCT03796676|142891312|SUPERIORITY||Estimate of difference|20.6||||0.003|TWO_SIDED|95.0|7.3|33.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||33.9|7.3|0.0030
71687091|NCT03796676|142891313|SUPERIORITY||Estimate of difference|26.5||||0.0002|TWO_SIDED|95.0|13.1|39.8|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||39.8|13.1|0.0002
71687092|NCT03796676|142891313|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.3|42.5|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||42.5|16.3|<0.0001
71687093|NCT03796676|142891314|SUPERIORITY||Estimate of difference|14.7||||0.0119||95.0|3.5|25.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo|||25.9|3.5|0.0119
71687094|NCT03796676|142891314|SUPERIORITY||Estimate of difference|26.1|||<|0.0001|TWO_SIDED|95.0|13.9|38.3|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo|||38.3|13.9|<0.0001
71687095|NCT03796676|142891314|SUPERIORITY||Estimate of difference|10.9||||0.0971|TWO_SIDED|95.0|-1.8|23.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo|||23.6|-1.8|0.0971
71687096|NCT03796676|142891314|SUPERIORITY||Estimate of difference|29.4|||<|0.0001|TWO_SIDED|95.0|16.0|42.9|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo|||42.9|16.0|<0.0001
71687097|NCT03796676|142891314|SUPERIORITY||Estimate of difference|22.8||||0.0035|TWO_SIDED|95.0|8.0|37.7|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo|||37.7|8.0|0.0035
71687098|NCT03796676|142891314|SUPERIORITY||Estimate of difference|25.6||||0.0013|TWO_SIDED|95.0|10.6|40.6|||Cochran-Mantel-Haenszel||Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo|||40.6|10.6|0.0013
71687099|NCT03796676|142891315|SUPERIORITY||Mean Difference (Net)|-0.5||||0.0664|TWO_SIDED|95.0|-1.1|0.0|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo|||0.0|-1.1|0.0664
71687100|NCT03796676|142891315|SUPERIORITY||Mean Difference (Net)|-0.7||||0.0142|TWO_SIDED|95.0|-1.3|-0.1|||Mixed Models Analysis||The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo|||-0.1|-1.3|0.0142
71687101|NCT02724410|142891357|OTHER|Chi Square test of independence||||||0.7188|||||||Chi-squared|||||||0.7188
71880214|NCT00552175|143279956|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-1.17|-0.56|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.||-0.56|-1.17|<0.0001
71880215|NCT00552175|143279958|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.27|-0.64||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.64|-1.27|<0.0001
71880216|NCT00552175|143279958|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.83|||<|0.0001|TWO_SIDED|95.0|-1.15|-0.51||P-value for Night Pain.|Mixed Models Analysis|Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.51|-1.15|<0.0001
71880217|NCT00552175|143279959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.87|||||TWO_SIDED|95.0|-1.26|-0.49|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.49|-1.26|
71880218|NCT00552175|143279959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.05|||||TWO_SIDED|95.0|-1.43|-0.66|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis||-0.66|-1.43|
71687102|NCT02724410|142891358|OTHER|Chi Square test of independence||||||0.5933|||||||Chi-squared|||||||.5933
71687103|NCT02724410|142891359|OTHER|Chi Square test of independence|||||>|0.99|||||||Chi-squared|||||||>.99
71687104|NCT02724410|142891360|OTHER|T-test for difference between groups|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<.0001
71687105|NCT02442206|142891361|SUPERIORITY||Mean Difference (Net)|10.27|||<|0.0001|TWO_SIDED|95.0|6.209|14.331|||ANOVA|||||14.331|6.209|<0.0001
71687106|NCT02442206|142891362|SUPERIORITY||Mean Difference (Net)|0.42|||<|0.0001|TWO_SIDED|95.0|0.36|0.49|||ANOVA|||||0.49|0.36|<0.0001
71687107|NCT02442206|142891363|SUPERIORITY||Mean Difference (Net)|0.67|||<|0.0001|TWO_SIDED|95.0|0.55|0.8|||ANOVA|||||0.80|0.55|<0.0001
71687108|NCT02442206|142891364|SUPERIORITY||Mean Difference (Net)|0.446|||<|0.0001|TWO_SIDED|95.0|0.352|0.541|||ANOVA|||||0.541|0.352|<0.0001
71687109|NCT02442206|142891365|SUPERIORITY||Mean Difference (Net)|-0.177||||0.0017|TWO_SIDED|95.0|-0.285|-0.07|||ANOVA|||||-0.070|-0.285|0.0017
71687110|NCT02442206|142891366|SUPERIORITY||Mean Difference (Net)|-0.751|||<|0.0001|TWO_SIDED|95.0|-0.925|-0.577|||ANOVA|||||-0.577|-0.925|<0.0001
71687111|NCT02442206|142891367|SUPERIORITY||Mean Difference (Net)|-1.639|||<|0.0001|TWO_SIDED|95.0|-1.945|-1.332|||ANOVA|||||-1.332|-1.945|<0.0001
71880219|NCT00552175|143279959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.17|-0.39|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.39|-1.17|
71880220|NCT00552175|143279959|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.28|-0.5|||Mixed Models Analysis|Covariates: Baseline value of night pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis||-0.5|-1.28|
71880221|NCT00552175|143279960|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||<|0.0001|TWO_SIDED|95.0|-0.85|-0.44|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.44|-0.85|<0.0001
71880222|NCT00552175|143279961|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.9|-0.39|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.39|-0.9|
71880223|NCT00552175|143279961|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.65|||||TWO_SIDED|95.0|-0.91|-0.4|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.4|-0.91|
71880224|NCT00552175|143279962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.61||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.61|-1.34|<0.0001
71687112|NCT02442206|142891368|SUPERIORITY||Mean Difference (Net)|-0.625|||<|0.0001|TWO_SIDED|95.0|-0.761|-0.489|||ANOVA|||||-0.489|-0.761|<0.0001
71687113|NCT02442206|142891369|SUPERIORITY||Mean Difference (Net)|1.209||||0.142|TWO_SIDED|95.0|-0.419|2.836|||ANOVA|||LV EF||2.836|-0.419|0.1420
71880225|NCT00552175|143279962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.21|-0.48||P-value for Least Pain.|Mixed Models Analysis|Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.48|-1.21|<0.0001
71880226|NCT00552175|143279962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.33|-0.67||P-value for Average Pain.|Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.67|-1.33|<0.0001
71880227|NCT00552175|143279962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.54||P-value for Pain Right Now.|Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.54|-1.29|<0.0001
71880228|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.89|||||TWO_SIDED|95.0|-1.34|-0.44|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.44|-1.34|
71880229|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.06|||||TWO_SIDED|95.0|-1.51|-0.62|||Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis||-0.62|-1.51|
71880230|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78|||||TWO_SIDED|95.0|-1.23|-0.33|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.33|-1.23|
71880231|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Mean Squares Difference|-0.91|||||TWO_SIDED|95.0|-1.36|-0.46|||Mixed Models Analysis|Covariates: Baseline value of least pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis||-0.46|-1.36|
71880232|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.98|||||TWO_SIDED|95.0|-1.39|-0.58|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.58|-1.39|
71880233|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.01|||||TWO_SIDED|95.0|-1.41|-0.61|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis||-0.61|-1.41|
71880234|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.88|||||TWO_SIDED|95.0|-1.35|-0.41|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.41|-1.35|
71880235|NCT00552175|143279963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.95|||||TWO_SIDED|95.0|-1.41|-0.48|||Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis||-0.48|-1.41|
71880236|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41||||0.0676|TWO_SIDED|95.0|-0.85|0.03||P-value for General Activity.|Mixed Models Analysis|Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.03|-0.85|0.0676
71880237|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37||||0.0933|TWO_SIDED|95.0|-0.8|0.06||P-value for Mood.|Mixed Models Analysis|Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.06|-0.8|0.0933
71880238|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49||||0.0228|TWO_SIDED|95.0|-0.91|-0.07||P-value for Walking Ability.|Mixed Models Analysis|Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.07|-0.91|0.0228
71880239|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.38||||0.0783|TWO_SIDED|95.0|-0.8|0.04||P-value for Normal Work.|Mixed Models Analysis|Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.04|-0.8|0.0783
71880240|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55||||0.0076|TWO_SIDED|95.0|-0.96|-0.15||P-value for Relation to People.|Mixed Models Analysis|Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.15|-0.96|0.0076
71880241|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.46||||0.0378|TWO_SIDED|95.0|-0.9|-0.03||P-value for Sleep.|Mixed Models Analysis|Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.03|-0.9|0.0378
71880242|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.56||||0.0089|TWO_SIDED|95.0|-0.98|-0.14||P-value for Enjoyment of Life.|Mixed Models Analysis|Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.14|-0.98|0.0089
71882876|NCT02484911|143284885|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.02
71882877|NCT02484911|143284886|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
71687114|NCT02442206|142891369|SUPERIORITY||Mean Difference (Net)|1.131||||0.1732|TWO_SIDED|95.0|-0.512|2.774|||ANOVA|||RV EF||2.774|-0.512|0.1732
71687115|NCT02442206|142891370|SUPERIORITY||Mean Difference (Net)|2.241||||0.0437|TWO_SIDED|95.0|0.066|4.417|||ANOVA|||LV ESV||4.417|0.066|0.0437
71687116|NCT02442206|142891370|SUPERIORITY||Mean Difference (Net)|2.095||||0.1236|TWO_SIDED|95.0|-0.591|4.782|||ANOVA|||RV ESV||4.782|-0.591|0.1236
71687117|NCT02442206|142891371|SUPERIORITY||Mean Difference (Net)|9.357||||0.0002|TWO_SIDED|95.0|4.649|14.065|||ANOVA|||||14.065|4.649|0.0002
71687118|NCT02442206|142891372|SUPERIORITY||Mean Difference (Net)|0.337||||0.0032|TWO_SIDED|95.0|0.118|0.555|||ANOVA|||LVCO||0.555|0.118|0.0032
71687119|NCT02442206|142891372|SUPERIORITY||Mean Difference (Net)|0.281||||0.0182|TWO_SIDED|95.0|0.05|0.512|||ANOVA|||RVCO||0.512|0.050|0.0182
71687120|NCT00497146|142891373|SUPERIORITY_OR_OTHER|||||||0.145||95.0|||||Mixed Models Analysis|Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.||||||0.145
71687121|NCT00929994|142891410|OTHER||||||=|0.06||||||A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all \>.05).|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.||||=0.06
71687122|NCT00929994|142891410|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.06
71687123|NCT00929994|142891411|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.01
71687124|NCT00929994|142891412|SUPERIORITY|||||||0.04||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts.|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.||||0.04
71687125|NCT00929994|142891413|SUPERIORITY||||||>|0.05||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.||||>0.05
71687126|NCT01964989|142891420|SUPERIORITY|Relative vaccine efficacy (rVE; ≥6 to \<72 months) rVE = (1-HR) is the relative vaccine efficacy of aQIV and HR is defined as hazard ratio between aQIV and non adjuvanted comparator.|Cox Proportional Hazard|-0.67|||||TWO_SIDED|95.0|-19.81|15.41||||||||15.41|-19.81|
71880243|NCT00552175|143279964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48||||0.0095|TWO_SIDED|95.0|-0.85|-0.12||P-value for Average of Interference Scores|Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||-0.12|-0.85|0.0095
71687127|NCT01964989|142891427|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% confidence interval (CI) on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.91|||||TWO_SIDED|95.0|1.8|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.8|
71687128|NCT01964989|142891427|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H1N1, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
71687129|NCT01964989|142891427|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|1.71|||||TWO_SIDED|95.0|1.6|1.8||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.8|1.6|
71687130|NCT01964989|142891427|OTHER||GMT ratio|1.57|||||TWO_SIDED|95.0|1.4|1.7||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for A/H3N2, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||1.7|1.4|
71687131|NCT01964989|142891427|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.19|||||TWO_SIDED|95.0|2.0|2.4||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.4|2.0|
71687132|NCT01964989|142891427|OTHER||GMT ratio|1.86|||||TWO_SIDED|95.0|1.7|2.0||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/YAM, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.0|1.7|
71687133|NCT01964989|142891427|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the adjusted ratio of GMTs for HI antibody titer exceeds 1.|GMT ratio|2.27|||||TWO_SIDED|95.0|2.0|2.6||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D22/50 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.6|2.0|
71687134|NCT01964989|142891427|OTHER||GMT ratio|1.8|||||TWO_SIDED|95.0|1.6|2.1||||||GMT ratio (aQIV/Comparator \[TIV/QIV\]) for B/VIC, D181/209 (Pooled Naïve \& Non-naïve). An adjusted analysis GMT model (log-transformed postvaccination HI titer = log-transformed prevaccination HI titer+treatment group+ age group, health status+ season + country) was used for analysis.||2.1|1.6|
71687135|NCT01964989|142891429|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.0||||||aQIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.0|0.8|
71687136|NCT01964989|142891429|OTHER||GMT ratio|1.02|||||TWO_SIDED|95.0|0.9|1.1||||||aQIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.9|
71687137|NCT01964989|142891429|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71687138|NCT01964989|142891429|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.8|1.1||||||aQIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71687139|NCT01964989|142891429|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H1N1 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71687140|NCT01964989|142891429|OTHER||GMT ratio|0.98|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for A/H3N2 at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71687141|NCT01964989|142891429|OTHER||GMT ratio|0.95|||||TWO_SIDED|95.0|0.8|1.1||||||TIV/QIV GMT ratio (High risk/Healthy) for B/YAM at D22/50 (Pooled Naïve \& Non-naïve).||1.1|0.8|
71687142|NCT01964989|142891429|OTHER||GMT ratio|0.92|||||TWO_SIDED|95.0|0.7|1.2||||||TIV/QIV GMT ratio (High risk/Healthy) for B/VIC at D22/50 (Pooled Naïve \& Non-naïve).||1.2|0.7|
71687143|NCT01964989|142891431|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|8.2|||||TWO_SIDED|95.0|5.0|11.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||11.3|5.0|
71687144|NCT01964989|142891431|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|5.2|||||TWO_SIDED|95.0|1.9|8.4||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||8.4|1.9|
71880244|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.6|||||TWO_SIDED|95.0|-1.14|-0.06|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||-0.06|-1.14|
71880245|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|||||TWO_SIDED|95.0|-0.77|0.32|||Mixed Models Analysis|Covariates: Baseline value of general activity, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis||0.32|-0.77|
71880246|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.27|||||TWO_SIDED|95.0|-0.8|0.27|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.27|-0.8|
71880247|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.48|||||TWO_SIDED|95.0|-1.01|0.05|||Mixed Models Analysis|Covariates: Baseline value of mood score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis||0.05|-1.01|
71880248|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||||TWO_SIDED|95.0|-1.02|0.02|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.02|-1.02|
71880249|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.49|||||TWO_SIDED|95.0|-1.01|0.03|||Mixed Models Analysis|Covariates: Baseline value of walking ability, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis||0.03|-1.01|
71880250|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.35|||||TWO_SIDED|95.0|-0.86|0.16|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.16|-0.86|
71882878|NCT02484911|143284887|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
71687145|NCT01964989|142891431|SUPERIORITY||Seroconversion difference|21.3|||||TWO_SIDED|95.0|18.1|24.5||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||24.5|18.1|
71687146|NCT01964989|142891431|SUPERIORITY|Superiority criterion: The lower bound of the two-sided 95% CI on the unadjusted difference of percentages of subjects seroconverted for HI antibody exceeds 0%.|Seroconversion difference|13.6|||||TWO_SIDED|95.0|10.0|17.3||||||Seroconversion difference (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||17.3|10.0|
71687147|NCT01964989|142891432|OTHER||Mean Difference (Final Values)|11.5|||||TWO_SIDED|95.0|9.4|13.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H1N1.||13.7|9.4|
71687148|NCT01964989|142891432|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for A/H3N2.||9.7|6.1|
71687149|NCT01964989|142891432|OTHER||Mean Difference (Final Values)|21.9|||||TWO_SIDED|95.0|18.1|25.6||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/YAM.||25.6|18.1|
71687150|NCT01964989|142891432|OTHER||Mean Difference (Final Values)|20.9|||||TWO_SIDED|95.0|15.9|25.7||||||Difference in HI titers ≥ 1:40 (aQIV - Comparator \[TIV/QIV\]) for B/VIC.||25.7|15.9|
71687151|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|5.9|9.7||||||Difference in HI titers ≥ 1:110 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.7|5.9|
71687152|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|9.8|||||TWO_SIDED|95.0|7.8|11.9||||||Difference in HI Titers ≥ 1:151 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||11.9|7.8|
71687153|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|16.1|||||TWO_SIDED|95.0|13.5|18.7||||||Difference in HI Titers ≥ 1:215 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||18.7|13.5|
71687154|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|23.1|||||TWO_SIDED|95.0|19.8|26.4||||||Difference in HI Titers ≥ 1:330 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||26.4|19.8|
71687155|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|24.1|||||TWO_SIDED|95.0|20.6|27.6||||||Difference in HI Titers ≥ 1:629 for A/H1N1 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||27.6|20.6|
71880251|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||||TWO_SIDED|95.0|-0.92|0.11|||Mixed Models Analysis|Covariates: Baseline value of normal work score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis||0.11|-0.92|
71880252|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.39|||||TWO_SIDED|95.0|-0.89|0.11|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||0.11|-0.89|
71880253|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.71|||||TWO_SIDED|95.0|-1.21|-0.22|||Mixed Models Analysis|Covariates: Baseline value of relation to people, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis||-0.22|-1.21|
71880254|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.57|||||TWO_SIDED|95.0|-1.11|-0.03|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||-0.03|-1.11|
71920403|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.7208|STANDARD_ERROR_OF_MEAN|0.6289||0.127|TWO_SIDED|95.0|-0.5283|1.97|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.9700|-0.5283|0.127
71920404|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.0574|STANDARD_ERROR_OF_MEAN|0.6461||0.053|TWO_SIDED|95.0|-0.2259|2.3406|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3406|-0.2259|0.053
71880255|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.36|||||TWO_SIDED|95.0|-0.9|0.18|||Mixed Models Analysis|Covariates: Baseline value of sleep score, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis||0.18|-0.9|
71880256|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.37|||||TWO_SIDED|95.0|-0.88|0.15|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||0.15|-0.88|
71880257|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.76|||||TWO_SIDED|95.0|-1.27|-0.24|||Mixed Models Analysis|Covariates: Baseline value of enjoyment of life, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis||-0.24|-1.27|
71880258|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.45|||||TWO_SIDED|95.0|-0.9|0.0|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||0|-0.9|
71880259|NCT00552175|143279965|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.52|||||TWO_SIDED|95.0|-0.97|-0.07|||Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis||-0.07|-0.97|
71880260|NCT00552175|143279966|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.11||||0.8517|TWO_SIDED|95.0|-1.22|1.01|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.01|-1.22|0.8517
71880261|NCT00552175|143279967|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34|||||TWO_SIDED|95.0|-1.03|1.71|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||1.71|-1.03|
71880262|NCT00552175|143279967|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.55|||||TWO_SIDED|95.0|-1.92|0.81|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|||0.81|-1.92|
71880263|NCT00078325|143279975|SUPERIORITY_OR_OTHER|||||||0.0001|||||||ANOVA|Treatment and country as factors.||||||0.0001
71920405|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2445|STANDARD_ERROR_OF_MEAN|0.6511||0.354|TWO_SIDED|95.0|-1.0486|1.5375|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.5375|-1.0486|0.354
71920406|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8055|STANDARD_ERROR_OF_MEAN|0.8615||0.176|TWO_SIDED|95.0|-0.9066|2.5177|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.5177|-0.9066|0.176
71920407|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0071|STANDARD_ERROR_OF_MEAN|0.8641||0.011|TWO_SIDED|95.0|0.2899|3.7242|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.7242|0.2899|0.011
71920408|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.7116|STANDARD_ERROR_OF_MEAN|0.852||0.024|TWO_SIDED|95.0|0.0184|3.4049|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4049|0.0184|0.024
71920409|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8585|STANDARD_ERROR_OF_MEAN|0.7844||0.138|TWO_SIDED|95.0|-0.6992|2.4163|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4163|-0.6992|0.138
71920410|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8807|STANDARD_ERROR_OF_MEAN|0.799||0.137|TWO_SIDED|95.0|-0.7064|2.4678|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.4678|-0.7064|0.137
71920411|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.2624|STANDARD_ERROR_OF_MEAN|0.8053||0.373|TWO_SIDED|95.0|-1.337|1.8618|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8618|-1.3370|0.373
71920412|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3239|STANDARD_ERROR_OF_MEAN|0.7472||0.333|TWO_SIDED|95.0|-1.1611|1.8089|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.8089|-1.1611|0.333
71920413|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1.9322|STANDARD_ERROR_OF_MEAN|0.7488||0.006|TWO_SIDED|95.0|0.4441|3.4203|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.4203|0.4441|0.006
71920414|NCT02055976|143362583|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.834|STANDARD_ERROR_OF_MEAN|0.7442||0.133|TWO_SIDED|95.0|-0.6451|2.313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.3130|-0.6451|0.133
71920415|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.0813|STANDARD_ERROR_OF_MEAN|2.0411||0.155|TWO_SIDED|95.0|-1.973|6.1356|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.1356|-1.9730|0.155
71920416|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.2608|STANDARD_ERROR_OF_MEAN|2.0965||0.062|TWO_SIDED|95.0|-0.9035|7.425|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.4250|-0.9035|0.062
71920417|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.8224|STANDARD_ERROR_OF_MEAN|2.1126||0.349|TWO_SIDED|95.0|-3.3733|5.0182|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.0182|-3.3733|0.349
71920418|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.3254|STANDARD_ERROR_OF_MEAN|2.7702||0.202|TWO_SIDED|95.0|-3.1801|7.831|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.8310|-3.1801|0.202
71920419|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|6.1048|STANDARD_ERROR_OF_MEAN|2.7784||0.015|TWO_SIDED|95.0|0.5833|11.6263|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||11.6263|0.5833|0.015
71922460|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.772|TWO_SIDED|95.0|-13.2|18.2|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.2|-13.2|0.772
71922461|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|12.8||||0.201|TWO_SIDED|95.0|-6.5|32.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||32.0|-6.5|0.201
71880264|NCT00078325|143279975|SUPERIORITY_OR_OTHER|||||||0.0008|||||||ANOVA|Treatment and country as factors.||||||0.0008
71880265|NCT00078325|143279976|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
71880266|NCT00078325|143279976|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.||||||<0.0001
71880267|NCT00578136|143279977|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|The Wilcoxon rank-sum test was used because the study did not have a normal distribution using the Kolmogorov-Smirnov test (p\<0.01).||Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.||||0.008
71880268|NCT04722042|143280039|SUPERIORITY|||||||0.557|||||||ANOVA|||comparison of word recognition over time (activation, and 1, 3, 6, and 12 months post-activation) between groups (default versus place-based)||||0.557
71880269|NCT04722042|143280040|SUPERIORITY|||||||0.208|||||||ANOVA|||comparison of spatial release from masking over time (1, 3, 6, and 12 months post-activation) between the groups (default versus place-based)||||0.208
71880270|NCT04722042|143280041|SUPERIORITY|||||||0.126|||||||ANOVA|||comparison of spatial release from masking between the groups over time||||0.126
71880271|NCT04722042|143280042|SUPERIORITY|||||||0.369|||||||ANOVA|||comparison of perceived benefit between the groups over time||||0.369
71880272|NCT04722042|143280043|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71880273|NCT04722042|143280044|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71880274|NCT04722042|143280045|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.02
71880275|NCT02321930|143280048|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
71880276|NCT02321930|143280049|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
71880277|NCT02321930|143280050|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
71880278|NCT02321930|143280051|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
71880279|NCT02321930|143280052|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months||||<0.0001
71880280|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 4||14.2|-5.0|
71880281|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 6B||9.5|-7.3|
71880282|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 9V||9.5|-7.3|
71880283|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.8|9.5||||||Comparison between treatments for common serotype 14||9.5|-7.8|
71880284|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 18C||14.2|-5.0|
71880285|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 19F||9.5|-7.3|
71880286|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 23F||9.5|-7.3|
71880287|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
71880288|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 3||9.5|-7.3|
71880289|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 5||9.5|-7.3|
71880290|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
71880291|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 7F||9.5|-7.3|
71880292|NCT00853749|143280055|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
71880293|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.8|||||TWO_SIDED|95.0|-8.6|12.7||||||Comparison between treatments for common serotype 4||12.7|-8.6|
71880294|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 6B||9.7|-7.5|
71880295|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 9V||9.7|-7.5|
71880296|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 14||9.7|-7.5|
71880297|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.4|10.0||||||Comparison between treatments for common serotype 18C||10.0|-7.4|
71880298|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.5|10.0||||||Comparison between treatments for common serotype 19F||10.0|-7.5|
71880299|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-10.8|8.1||||||Comparison between treatments for common serotype 23F||8.1|-10.8|
71880300|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|2.7|||||TWO_SIDED|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1||14.2|-5.0|
71880301|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.1|7.9||||||Comparison between treatments for additional serotype 3||7.9|-11.1|
71880302|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.7|||||TWO_SIDED|95.0|-8.5|12.2||||||Comparison between treatments for additional serotype 5||12.2|-8.5|
71880303|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A||9.5|-7.3|
71880304|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|-2.0|||||TWO_SIDED|95.0|-11.3|7.7||||||Comparison between treatments for additional serotype 7F||7.7|-11.3|
71880305|NCT00853749|143280056|SUPERIORITY_OR_OTHER_LEGACY||Difference in proportions (percentage)|0.0|||||TWO_SIDED|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A||9.5|-7.3|
71880306|NCT00853749|143280057|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.3|||||TWO_SIDED|95.0|0.22|0.42|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.42|0.22|
71880307|NCT00853749|143280057|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.32|||||TWO_SIDED|95.0|0.23|0.44|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.44|0.23|
71880308|NCT00853749|143280057|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.44|||||TWO_SIDED|95.0|0.29|0.67|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.67|0.29|
71880309|NCT00853749|143280057|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.88|||||TWO_SIDED|95.0|0.61|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.61|
71880310|NCT00853749|143280057|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric means|0.47|||||TWO_SIDED|95.0|0.34|0.65|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.65|0.34|
71880311|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.35|1.12|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.12|0.35|
71880312|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.68|1.38|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.38|0.68|
71880313|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.51|1.81|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.81|0.51|
71880314|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.0|||||TWO_SIDED|95.0|0.67|1.48|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.48|0.67|
71880315|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.33|0.98|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.98|0.33|
71880316|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.1|||||TWO_SIDED|95.0|0.72|1.56|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.56|0.72|
71880317|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.6|||||TWO_SIDED|95.0|0.39|0.99|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.99|0.39|
71880318|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.2|||||TWO_SIDED|95.0|0.12|0.32|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.32|0.12|
71880319|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.56|1.18|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.18|0.56|
71880320|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.4|||||TWO_SIDED|95.0|0.21|0.63|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.63|0.21|
71880321|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|1.4|||||TWO_SIDED|95.0|0.88|2.25|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||2.25|0.88|
71880322|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.7|||||TWO_SIDED|95.0|0.48|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.48|
71880323|NCT00853749|143280058|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMTs|0.8|||||TWO_SIDED|95.0|0.54|1.2|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.20|0.54|
71880324|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.37|||||TWO_SIDED|95.0|0.25|0.55|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.55|0.25|
71880325|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.71|||||TWO_SIDED|95.0|0.44|1.15|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.15|0.44|
71880326|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.58|||||TWO_SIDED|95.0|0.45|0.75|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.75|0.45|
71880327|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.77|||||TWO_SIDED|95.0|0.48|1.24|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.24|0.48|
71880328|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.57|||||TWO_SIDED|95.0|0.38|0.85|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.85|0.38|
71880329|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.84|||||TWO_SIDED|95.0|0.56|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.27|0.56|
71880330|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.64|||||TWO_SIDED|95.0|0.44|0.95|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.95|0.44|
71880331|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.27|||||TWO_SIDED|95.0|0.18|0.4|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.40|0.18|
71880332|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|1.14|||||TWO_SIDED|95.0|0.76|1.72|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.72|0.76|
71880333|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.36|||||TWO_SIDED|95.0|0.25|0.51|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||0.51|0.25|
71880334|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.79|||||TWO_SIDED|95.0|0.55|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.14|0.55|
71880335|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.89|||||TWO_SIDED|95.0|0.61|1.28|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.28|0.61|
71880336|NCT00853749|143280059|SUPERIORITY_OR_OTHER_LEGACY||Ratio of GMCs|0.86|||||TWO_SIDED|95.0|0.6|1.23|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).||1.23|0.60|
71880337|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.253|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any tenderness||||0.253
71880338|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.38|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for significant tenderness||||0.380
71880339|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.135|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any redness||||0.135
71920420|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.2393|STANDARD_ERROR_OF_MEAN|2.7396||0.03|TWO_SIDED|95.0|-0.2058|10.6845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.6845|-0.2058|0.030
71920421|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1827|STANDARD_ERROR_OF_MEAN|2.4251||0.185|TWO_SIDED|95.0|-2.6334|6.9988|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.9988|-2.6334|0.185
71920422|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.1376|STANDARD_ERROR_OF_MEAN|2.4716||0.195|TWO_SIDED|95.0|-2.7718|7.0469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0469|-2.7718|0.195
71920423|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.3113|STANDARD_ERROR_OF_MEAN|2.4909||0.45|TWO_SIDED|95.0|-4.6358|5.2584|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2584|-4.6358|0.450
71920424|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.6078|STANDARD_ERROR_OF_MEAN|2.3322||0.397|TWO_SIDED|95.0|-4.0274|5.2431|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.2431|-4.0274|0.397
71920425|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.7096|STANDARD_ERROR_OF_MEAN|2.3367||0.008|TWO_SIDED|95.0|1.0659|10.3532|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.3532|1.0659|0.008
71920426|NCT02055976|143362584|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.4558|STANDARD_ERROR_OF_MEAN|2.323||0.147|TWO_SIDED|95.0|-2.1608|7.0724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.0724|-2.1608|0.147
71920427|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.9203|STANDARD_ERROR_OF_MEAN|1.3242|<|0.001|TWO_SIDED|95.0|-7.5504|-2.2901|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.2901|-7.5504|<0.001
71920428|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.1983|STANDARD_ERROR_OF_MEAN|1.3462|<|0.001|TWO_SIDED|95.0|-9.8718|-4.5249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.5249|-9.8718|<0.001
71920429|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.3118|STANDARD_ERROR_OF_MEAN|1.3505|<|0.001|TWO_SIDED|95.0|-9.9935|-4.6301|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.6301|-9.9935|<0.001
71920430|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.0629|STANDARD_ERROR_OF_MEAN|1.032||0.002|TWO_SIDED|95.0|-5.1132|-1.0125|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.0125|-5.1132|0.002
71920431|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.6209|STANDARD_ERROR_OF_MEAN|1.0367|<|0.001|TWO_SIDED|95.0|-5.6804|-1.5614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5614|-5.6804|<0.001
71687156|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|5.9|||||TWO_SIDED|95.0|4.5|7.5||||||Difference in HI Titers ≥ 1:110 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||7.5|4.5|
71687157|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|7.8|||||TWO_SIDED|95.0|6.1|9.6||||||Difference in HI Titers ≥ 1:151 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.6|6.1|
71687158|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|11.7|||||TWO_SIDED|95.0|9.6|13.9||||||Difference in HI Titers ≥ 1:215 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||13.9|9.6|
71687159|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|19.0|||||TWO_SIDED|95.0|16.1|22.0||||||Difference in HI Titers ≥ 1:330 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||22.0|16.1|
71687160|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|21.1|||||TWO_SIDED|95.0|17.8|24.3||||||Difference in HI Titers ≥ 1:629 for A/H3N2 (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||24.3|17.8|
71687161|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|28.8|||||TWO_SIDED|95.0|25.1|32.3||||||Difference in HI Titers ≥ 1:110 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||32.3|25.1|
71687162|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|26.3|||||TWO_SIDED|95.0|22.6|29.9||||||Difference in HI Titers ≥ 1:151 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||29.9|22.6|
71687163|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|18.3|25.3||||||Difference in HI Titers ≥ 1:215 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||25.3|18.3|
71687164|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|11.6|||||TWO_SIDED|95.0|8.6|14.5||||||Difference in HI Titers ≥ 1:330 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||14.5|8.6|
71687165|NCT01964989|142891433|OTHER||Mean Difference (Final Values)|6.8|||||TWO_SIDED|95.0|4.3|9.4||||||Difference in HI Titers ≥ 1:629 for B/YAM (aQIV - Comparator \[TIV/QIV\]) at Day 22/50.||9.4|4.3|
71687166|NCT00424593|142891443|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.|Repeated Measures Analysis|||||||0.004
71687167|NCT00424593|142891444|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||||||0.014
71687168|NCT00424593|142891445|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value is for 13 Week Change from Baseline.|ANCOVA|||||||0.009
71687169|NCT00424593|142891446|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Average Pain Score Change from Baseline.|ANCOVA|||||||0.002
71687170|NCT00424593|142891446|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||P-value for Worst Pain Score Change from Baseline.|ANCOVA|||||||0.014
71687171|NCT00424593|142891446|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||P-value for Night Pain Score Change from Baseline.|ANCOVA|||||||0.007
71687172|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Worst Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.011
71687173|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Least Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.001
71687174|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Average Pain Score Week 13 Change from Baseline.|ANCOVA|||||||0.019
71687175|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pain Right Now Score Week 13 Change from Baseline.|ANCOVA|||||||0.002
71687176|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for General Activity Week 13 Change from Baseline.|ANCOVA|||||||0.068
71687177|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Mood Week 13 Change from Baseline.|ANCOVA|||||||0.009
71687178|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||P-value for Walking Ability Week 13 Change from Baseline.|ANCOVA|||||||0.006
71687179|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||P-value for Normal Work Week 13 Change from Baseline.|ANCOVA|||||||0.024
71687180|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Relations With People Week 13 Change from Baseline.|ANCOVA|||||||0.005
71687181|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Sleep Week 13 Change from Baseline.|ANCOVA|||||||0.051
71687182|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||P-value for Enjoyment of Life Week 13 Change from Baseline.|ANCOVA|||||||0.013
71687183|NCT00424593|142891447|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Average Interference Week 13 Change from Baseline.|ANCOVA|||||||0.005
71687184|NCT00424593|142891448|SUPERIORITY_OR_OTHER|||||||0.092||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.092
71687185|NCT00424593|142891449|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Fisher Exact|||||||0.060
71687186|NCT00424593|142891450|SUPERIORITY_OR_OTHER|||||||0.087||95.0|||||Fisher Exact|||||||0.087
71687187|NCT00424593|142891451|SUPERIORITY_OR_OTHER|||||||0.329||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.329
71687188|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.051||95.0||||P-value for Mental Component Summary Change from Baseline.|ANCOVA|||||||0.051
71687189|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.22||95.0||||P-value for Physical Component Summary Change from Baseline.|ANCOVA|||||||0.220
71687190|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||P-value for Bodily Pain Change from Baseline.|ANCOVA|||||||0.038
71687191|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.041||95.0||||P-value for General Health Change from Baseline.|ANCOVA|||||||0.041
71687192|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for Mental Health Change from Baseline.|ANCOVA|||||||0.093
71687193|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for Physical Functioning Change from Baseline.|ANCOVA|||||||0.210
71687194|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Role-Emotional Change from Baseline.|ANCOVA|||||||0.170
71687195|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.306||95.0||||P-value for Role-Physical Change from Baseline.|ANCOVA|||||||0.306
71687196|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.053||95.0||||P-value for Social Functioning Change from Baseline.|ANCOVA|||||||0.053
71687197|NCT00424593|142891452|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||P-value for Vitality Change from Baseline.|ANCOVA|||||||0.040
71687198|NCT00424593|142891453|SUPERIORITY_OR_OTHER|||||||0.117||95.0||||P-value for Change from Baseline.|ANCOVA|||||||0.117
71687199|NCT00424593|142891454|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||P-value for Absenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.063
71687200|NCT00424593|142891454|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||P-value for Presenteeism Week 13 Change from Baseline.|ANCOVA|||||||0.452
71687201|NCT00424593|142891454|SUPERIORITY_OR_OTHER|||||||0.736||95.0||||P-value for Work Productivity Loss Week 13 Change from Baseline.|ANCOVA|||||||0.736
71687202|NCT00424593|142891454|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Work Activity Impairment Week 13 Change from Baseline.|ANCOVA|||||||0.002
71687203|NCT00424593|142891455|SUPERIORITY_OR_OTHER|||||||0.177||95.0||||P-value for Week 13 Change from Baseline.|ANCOVA|||||||0.177
71687204|NCT00424593|142891456|SUPERIORITY_OR_OTHER|||||||0.122||95.0||||P-value for Anxiety Subscale Change from Baseline.|ANCOVA|||||||0.122
71687205|NCT00424593|142891456|SUPERIORITY_OR_OTHER|||||||0.262||95.0||||P-value for Depression Subscale Change from Baseline.|ANCOVA|||||||0.262
71687206|NCT00424593|142891457|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.046
71687207|NCT00424593|142891458|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.||||||0.008
71687208|NCT00424593|142891459|SUPERIORITY_OR_OTHER|||||||0.028||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.028
71687209|NCT00424593|142891460|SUPERIORITY_OR_OTHER|||||||0.764||95.0||||P-value for SBP Week 13 Change from Baseline.|ANOVA|||||||0.764
71687210|NCT00424593|142891460|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for DBP Week 13 Change from Baseline.|ANOVA|||||||0.093
71687211|NCT00424593|142891461|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||P-value for Week 13 Change from Baseline.|ANOVA|||||||0.008
71687212|NCT01796301|142891464|SUPERIORITY|A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below.|Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.7|3.8|||Linear mixed effects repeated measures|||The primary analysis to assess the treatment difference (Romosozumab - Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.||3.8|2.7|< 0.0001
71687213|NCT01796301|142891465|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.7|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.7|2.5|< 0.0001
71687214|NCT01796301|142891466|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
71687215|NCT01796301|142891467|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.0|2.8|< 0.0001
71687216|NCT01796301|142891468|SUPERIORITY||Treatment difference|4.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|3.9|5.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||5.3|3.9|< 0.0001
71687217|NCT01796301|142891469|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.5|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.5|< 0.0001
71687218|NCT01796301|142891470|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
71880340|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild redness||||0.520
71687219|NCT01796301|142891471|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.4|3.8|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.8|2.4|< 0.0001
71687220|NCT01796301|142891472|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.6|<|0.0001|TWO_SIDED|95.0|2.1|4.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.3|2.1|< 0.0001
71687221|NCT01796301|142891473|SUPERIORITY||Treatment difference|3.1|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.6|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||3.6|2.6|< 0.0001
71687222|NCT01796301|142891474|SUPERIORITY||Treatment difference|3.6|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.||4.2|2.9|< 0.0001
71880341|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.283|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate redness||||0.283
71880342|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.225|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe redness||||0.225
71880343|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.202|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for any swelling||||0.202
71880344|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.294|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for mild swelling||||0.294
71880345|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.175|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for moderate swelling||||0.175
71687223|NCT01796301|142891475|SUPERIORITY||Treatment difference|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.5|3.9|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||3.9|2.5|< 0.0001
71920432|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.1778|STANDARD_ERROR_OF_MEAN|1.0269|<|0.001|TWO_SIDED|95.0|-6.2184|-2.1372|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.1372|-6.2184|<0.001
71920433|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.2914|STANDARD_ERROR_OF_MEAN|1.2954||0.006|TWO_SIDED|95.0|-5.8649|-0.7178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.7178|-5.8649|0.006
71920434|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3569|STANDARD_ERROR_OF_MEAN|1.3157|<|0.001|TWO_SIDED|95.0|-8.9706|-3.7432|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7432|-8.9706|<0.001
71920435|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.3962|STANDARD_ERROR_OF_MEAN|1.3233|<|0.001|TWO_SIDED|95.0|-9.0247|-3.7677|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.7677|-9.0247|<0.001
71920436|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.9228|STANDARD_ERROR_OF_MEAN|0.9199|<|0.001|TWO_SIDED|95.0|-5.7506|-2.095|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.0950|-5.7506|<0.001
71920437|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.7094|STANDARD_ERROR_OF_MEAN|0.9244|<|0.001|TWO_SIDED|95.0|-6.5459|-2.8729|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.8729|-6.5459|<0.001
71920438|NCT02055976|143362586|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.4374|STANDARD_ERROR_OF_MEAN|0.9187|<|0.001|TWO_SIDED|95.0|-6.263|-2.6118|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.6118|-6.2630|<0.001
71920439|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.4492|STANDARD_ERROR_OF_MEAN|10.2401||0.004|TWO_SIDED|95.0|-47.7872|-7.1112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.1112|-47.7872|0.004
71920440|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.5908|STANDARD_ERROR_OF_MEAN|10.4568|<|0.001|TWO_SIDED|95.0|-61.3577|-19.824|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-19.8240|-61.3577|<0.001
71920441|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-27.163|STANDARD_ERROR_OF_MEAN|10.5402||0.006|TWO_SIDED|95.0|-48.0927|-6.2332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.2332|-48.0927|0.006
71922462|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-10.4||||0.256|TWO_SIDED|95.0|-27.3|6.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.5|-27.3|0.256
71922463|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.519|TWO_SIDED|95.0|-11.4|23.5|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.5|-11.4|0.519
71922464|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|16.7||||0.094|TWO_SIDED|95.0|-1.9|35.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||35.2|-1.9|0.094
71922465|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.8||||0.76|TWO_SIDED|95.0|-14.4|20.1|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||20.1|-14.4|0.760
71880346|NCT00853749|143280060|SUPERIORITY_OR_OTHER_LEGACY|||||||0.314|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for severe swelling||||0.314
71880347|NCT00853749|143280061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C||||> .99
71880348|NCT00853749|143280061|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.99|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased appetite||||> .99
71880349|NCT00853749|143280061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.543|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for irritability||||0.543
71880350|NCT00853749|143280061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.233|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for increased sleep||||0.233
71880351|NCT00853749|143280061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.198|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for decreased sleep||||0.198
71880352|NCT00853749|143280061|SUPERIORITY_OR_OTHER_LEGACY|||||||0.628|TWO_SIDED||||||Fisher Exact|||Comparison between treatments for rash||||0.628
71880353|NCT00255970|143280077|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.||||>.05
71880354|NCT00255970|143280077|SUPERIORITY_OR_OTHER||||||>|0.05||||||The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|ANOVA|||A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.||||>0.05
71880355|NCT00255970|143280078|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>.05
71880356|NCT00255970|143280079|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANOVA|||The change in recession, measured in mm, had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
71880357|NCT00255970|143280080|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.||||>0.05
71880358|NCT00255970|143280081|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).||||>0.05
71880359|NCT01392677|143280084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.1022|<|0.0001|TWO_SIDED|95.0|-0.89|-0.49||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Mixed Models Analysis|Longitudinal repeated measures model using mixed model with treatment group, baseline value, week and week\*treatment and week\*baseline||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.49|-0.89|<0.0001
71880360|NCT01392677|143280085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.45|STANDARD_ERROR_OF_MEAN|4.8846|<|0.0001|TWO_SIDED|95.0|-43.08|-23.82||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-23.82|-43.08|<0.0001
71880361|NCT01392677|143280086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|0.3651|<|0.0001|TWO_SIDED|95.0|-2.79|-1.35||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.35|-2.79|<0.0001
71880362|NCT01392677|143280087|SUPERIORITY_OR_OTHER||Risk Difference (RD)|20.7|STANDARD_ERROR_OF_MEAN|5.056|<|0.0001|TWO_SIDED|95.0|10.7|30.6||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Tsiatis, Davidian, Zhang \& Lu, with adjustment for baseline value||H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0||30.6|10.7|<0.0001
71880363|NCT01392677|143280088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.76|STANDARD_ERROR_OF_MEAN|1.6677||0.025|TWO_SIDED|95.0|-7.05|-0.48||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.48|-7.05|0.025
71880364|NCT03996876|143280089|SUPERIORITY|Given the relatively small sample size, results of our inferential statistical tests should be interpreted with caution.|F Statistic|1.032||||0.322|TWO_SIDED|||||The a priori threshold for statistical significance was set at 0.05.|ANOVA|We conducted a two-way mixed ANOVA with intervention as the between-subjects and time as the within-subjects variable.|The F Statistic reported is for the interaction between Intervention and Time.|||||0.322
71880365|NCT02726971|143280092|SUPERIORITY_OR_OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71920442|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.1677|STANDARD_ERROR_OF_MEAN|8.8755||0.004|TWO_SIDED|95.0|-41.8023|-6.5332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.5332|-41.8023|0.004
71880366|NCT01538628|143280118|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||Exact binomial test|testing the null hypothesis that the proportion for SpaceOAR is less than or equal to 0.70.||||||.0001
71880367|NCT03080883|143280125|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.3117|TWO_SIDED|95.0|0.38|1.37|||Gray Test P-value|||||1.37|0.38|0.3117
71920443|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.2255|STANDARD_ERROR_OF_MEAN|8.9203||0.017|TWO_SIDED|95.0|-36.9471|-1.5038|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.5038|-36.9471|0.017
71920444|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-26.5155|STANDARD_ERROR_OF_MEAN|8.8387||0.002|TWO_SIDED|95.0|-44.0795|-8.9515|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.9515|-44.0795|0.002
71920445|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-18.3898|STANDARD_ERROR_OF_MEAN|5.1768|<|0.001|TWO_SIDED|95.0|-28.6698|-8.1097|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-8.1097|-28.6698|<0.001
71880368|NCT03080883|143280126|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.997|TWO_SIDED|95.0|0.4|2.53|||Gray Test P-value|||||2.53|0.40|0.9970
71880369|NCT04360551|143280145|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
71880370|NCT04360551|143280146|SUPERIORITY||||||>|0.5|||||||Kruskal-Wallis|||||||>0.5
71880371|NCT01761292|143280190|OTHER||mean|13.906|||<|0.0001|TWO_SIDED|95.0|11.5657|16.2466||The paired t-test or non-parametric signed rank test for 2 means (paired observations) (as is appropriate) was applied for testing the statistical significance of the Change From Baseline to End of Study. MFA% P \< 0.05 was set as significant.|t-test, 2 sided|||||16.2466|11.5657|<0.0001
71880372|NCT01761292|143280191|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||< 0.0001
71880373|NCT02535715|143280205|SUPERIORITY|ANOVA Bonferroni adjustment|||||<|0.05|||||||ANOVA|||||||<0.05
71920446|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.7882|STANDARD_ERROR_OF_MEAN|5.264|<|0.001|TWO_SIDED|95.0|-47.2423|-26.3341|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3341|-47.2423|<0.001
71920447|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-36.8453|STANDARD_ERROR_OF_MEAN|5.3084|<|0.001|TWO_SIDED|95.0|-47.3864|-26.3041|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-26.3041|-47.3864|<0.001
71920448|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.9411|STANDARD_ERROR_OF_MEAN|7.8656|<|0.001|TWO_SIDED|95.0|-48.5748|-17.3075|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.3075|-48.5748|<0.001
71920449|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.3176|STANDARD_ERROR_OF_MEAN|7.9032|<|0.001|TWO_SIDED|95.0|-47.0238|-15.6114|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.6114|-47.0238|<0.001
71922466|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.95|TWO_SIDED|95.0|-16.8|18.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.0|-16.8|0.950
71922467|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|13.6||||0.185|TWO_SIDED|95.0|-5.9|33.0|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||33.0|-5.9|0.185
71922468|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.2||||0.982|TWO_SIDED|95.0|-18.8|19.3|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||19.3|-18.8|0.982
71922469|NCT00883896|143365378|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-11.6||||0.223|TWO_SIDED|95.0|-29.0|5.8|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-29.0|0.223
71922470|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.885|TWO_SIDED|95.0|-6.8|5.8|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.8|-6.8|0.885
71687224|NCT01796301|142891476|SUPERIORITY||Treatment difference|3.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.6|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.2|2.6|< 0.0001
71687225|NCT01796301|142891477|SUPERIORITY||Treatment difference|3.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||4.6|2.9|< 0.0001
71687226|NCT01796301|142891478|SUPERIORITY||Treatment difference|4.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|3.4|5.4|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab - Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.||5.4|3.4|< 0.0001
71687227|NCT01537835|142891505|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|||||p-value is adjusted for multiple comparisons|Kruskal-Wallis|||||||0.17
71687228|NCT02087943|142891533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-15.01||||0.1308|TWO_SIDED|95.0|-34.52|4.5||Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||4.50|-34.52|0.1308
71687229|NCT02087943|142891533|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-20.6||||0.0347|TWO_SIDED|95.0|-39.7|-1.5||Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, \> 20) as factors.|ANCOVA|||||-1.50|-39.70|0.0347
71687230|NCT02087943|142891534|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-2.7||||0.4938|TWO_SIDED|95.0|-10.2|4.8||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, Cochran-Mantel-Haenszel (CMH) weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||4.8|-10.2|0.4938
71880374|NCT03901105|143280207|OTHER||Risk Ratio (RR)|1.36||||0.0313|TWO_SIDED|95.0|1.028|1.785||A priori threshold was two-sided 0.05.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline CDR-SB score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.785|1.028|0.0313
71880375|NCT03901105|143280208|OTHER||Risk Ratio (RR)|1.35||||0.0833|TWO_SIDED|95.0|0.962|1.886||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for MMSE CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.886|0.962|.0833
71880376|NCT03901105|143280208|OTHER||Risk Ratio (RR)|1.77||||0.0141|TWO_SIDED|95.0|1.122|2.796||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for ADAS-Cog11 CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.796|1.122|.0141
71880377|NCT03901105|143280208|OTHER||Risk Ratio (RR)|1.32||||0.0639|TWO_SIDED|95.0|0.984|1.776||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for FAQ CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||1.776|0.984|.0639
71687231|NCT02087943|142891534|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|8.0||||0.1368|TWO_SIDED|95.0|-2.3|18.2||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with, CMH weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.|||18.2|-2.3|0.1368
71687232|NCT02087943|142891535|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|-1.5||||0.8589|TWO_SIDED|95.0|-18.0|14.9|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||14.9|-18.0|0.8589
71687233|NCT02087943|142891535|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference in Proportion|9.9||||0.2476|TWO_SIDED|95.0|-6.7|26.6|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, \> 20) with the CMH weights.|||26.6|-6.7|0.2476
71687234|NCT02087943|142891536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-5.17||||0.5286|TWO_SIDED|95.0|-21.34|10.99|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||10.99|-21.34|0.5286
71880378|NCT03901105|143280208|OTHER||Risk Ratio (RR)|1.28||||0.2814|TWO_SIDED|95.0|0.815|2.02||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|log linear model|Adjusted for treatment arm (lanabecestat 20 mg, 50 mg, or placebo), baseline age, years of education (categorical), and baseline score.|τAD++ scans represent the numerator for risk, and τAD+/τAD- scans represent the denominator|Risk ratio for CDR Global CMD. Scan results were grouped into τAD++ vs. non-τAD++ (τAD+ and τAD-) for the analysis||2.020|0.815|.2814
71882879|NCT02484911|143284889|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
71687235|NCT02087943|142891536|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.17||||0.6092|TWO_SIDED|95.0|-20.22|11.88|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, \> 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.|||11.88|-20.22|0.6092
71880379|NCT03901105|143280209|OTHER|||||||0.0305||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between CDR-SB least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||.0305
71687236|NCT03836209|142891541|SUPERIORITY||Proportion Difference|-0.071||||0.366|TWO_SIDED|90.0|-0.205|0.062||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.062|-0.205|0.366
71687237|NCT03836209|142891542|SUPERIORITY||Proportion Difference|-0.059||||0.446|TWO_SIDED|90.0|-0.191|0.073||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.073|-0.191|0.446
71687238|NCT03836209|142891543|SUPERIORITY||Proportion Difference|0.047||||0.539|TWO_SIDED|90.0|-0.084|0.178||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.178|-0.084|0.539
71687239|NCT03836209|142891544|SUPERIORITY||Proportion Difference|0.131||||0.042|TWO_SIDED|90.0|0.02|0.242||The threshold for statistical significance was p = 0.10.|Fisher Exact||Treatment Difference = Arm A - Arm B|||0.242|0.020|0.042
71687240|NCT01424241|142891549|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|300.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||None available.||||<0.05
71880380|NCT03901105|143280209|OTHER||||||<|0.0001||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between MMSE least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||<0.0001
71880381|NCT03901105|143280209|OTHER|||||||0.0006||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between ADAS-Cog11 least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0006
71687241|NCT01424241|142891549|SUPERIORITY||Mean Difference (Final Values)|1.6|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<.05
71687242|NCT05259917|142891553|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||<0.0001
71880382|NCT03901105|143280209|OTHER|||||||0.0097||||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|Mixed Models Analysis|Adjusted for baseline clinical score, age, years of education (categorical), and treatment arm (lanabecestat - 20mg or 50mg - or placebo).||MMRM testing the difference between FAQ least squares mean changes of tAD++ and Non-tAD++ (tAD+ and tAD-). The unstructured covariance structure (UN) was used.||||0.0097
71880383|NCT02700412|143280241|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
71882880|NCT02484911|143284890|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
71882881|NCT02484911|143284891|SUPERIORITY_OR_OTHER|||||||1|||||||Chi-squared|||||||1.0
71882882|NCT02484911|143284892|SUPERIORITY_OR_OTHER|||||||0.246|||||||Chi-squared|||||||0.246
71687243|NCT05259917|142891553|SUPERIORITY|||||||0.0013|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0013
71687244|NCT05259917|142891554|SUPERIORITY|||||||0.0036|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0036
71687245|NCT05259917|142891554|SUPERIORITY|||||||0.0032|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||0.0032
71687246|NCT05259917|142891555|SUPERIORITY|||||||0.0022|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 300 mg vs Placebo"||||0.0022
71687247|NCT05259917|142891555|SUPERIORITY||||||<|0.0001|||||||Gehan score transformation test|||"Gehan score transformation test:~KVD900 600 mg vs Placebo"||||<0.0001
71687248|NCT00482170|142891556|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.32|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.87|1.77||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.77|0.87|<0.001
71882883|NCT04129528|143284894|SUPERIORITY||Ratio of geometric means CFZ533/placebo|1.173||||0.1817|TWO_SIDED|80.0|0.94|1.47||one-sided P-value|Mixed model repeated measure analysis|||||1.47|0.94|0.1817
71882884|NCT01964352|143284911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.293|0.369|||Mixed Effects Model for Repeated Measure|||||0.369|0.293|<0.0001
71882885|NCT01964352|143284911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.075|0.148|||Mixed Effects Model for Repeated Measure|||||0.148|0.075|<0.0001
71687249|NCT00482170|142891557|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.41|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|0.95|1.87||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||1.87|0.95|<0.001
71687250|NCT00482170|142891558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|16.12||||0.008|TWO_SIDED|95.0|2.05|126.9||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||126.9|2.05|0.008
71687251|NCT00482170|142891558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.25||||0.002|TWO_SIDED|95.0|2.44|51.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||51.83|2.44|0.002
71687252|NCT00482170|142891558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.88||||0.001|TWO_SIDED|95.0|2.26|27.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.||27.44|2.26|0.001
71687253|NCT00482170|142891558|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.73|||<|0.001|TWO_SIDED|95.0|2.59|29.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used for the analysis.||29.47|2.59|<0.001
71687254|NCT00482170|142891559|SUPERIORITY_OR_OTHER||Regression coefficient|0.17||||0.045|TWO_SIDED|95.0|0.0|0.34||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.34|0.00|0.045
71880384|NCT02700412|143280242|OTHER|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.|||<0.0001
71880385|NCT00632099|143280243|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||||||<0.05
71880386|NCT05112536|143280251|OTHER|||||||0.101|||||||Wilcoxon signed-rank test|||||||0.101
71882886|NCT01964352|143284911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.262|0.337|||Mixed Effects Model for Repeated Measure|||||0.337|0.262|<0.0001
71882887|NCT01964352|143284911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001|TWO_SIDED|95.0|0.044|0.116|||Mixed Effects Model for Repeated Measure|||||0.116|0.044|<0.0001
71920450|NCT02055976|143362587|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.847|STANDARD_ERROR_OF_MEAN|7.8576|<|0.001|TWO_SIDED|95.0|-48.465|-17.2289|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.2289|-48.4650|<0.001
71687255|NCT00482170|142891560|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.707|TWO_SIDED|95.0|-0.58|0.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, female and male (reference).||0.39|-0.58|0.707
71687256|NCT00482170|142891561|SUPERIORITY_OR_OTHER||Regression coefficient|-0.38||||0.195|TWO_SIDED|95.0|-0.89|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).||0.14|-0.89|0.195
71687257|NCT00482170|142891561|SUPERIORITY_OR_OTHER||Regression coefficient|-0.55||||0.195|TWO_SIDED|95.0|-1.21|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).||0.11|-1.21|0.195
71687258|NCT00482170|142891562|SUPERIORITY_OR_OTHER||Regression coefficient|-0.09||||0.493|TWO_SIDED|95.0|-0.36|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-A: =\< 4, HAD-A: \> 4 to 7, HAD-A: \> 7 to 10 and HAD-A: \> 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.36|0.493
71882888|NCT01964352|143284911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001|TWO_SIDED|95.0|0.181|0.258|||Mixed Effects Model for Repeated Measure|||||0.258|0.181|<0.0001
71920451|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.663|STANDARD_ERROR_OF_MEAN|1.431|<|0.001|TWO_SIDED|95.0|4.82|10.506|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.506|4.820|<0.001
71687259|NCT00482170|142891562|SUPERIORITY_OR_OTHER||Regression coefficient|-0.16||||0.287|TWO_SIDED|95.0|-0.46|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-D: =\< 3, HAD-D: \> 3 to 5, HAD-D: \> 5 to 8 and HAD-A: \> 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.14|-0.46|0.287
71687260|NCT00482170|142891563|SUPERIORITY_OR_OTHER||Regression coefficient|0.13||||0.123|TWO_SIDED|95.0|-0.04|0.3||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.30|-0.04|0.123
71687261|NCT00482170|142891564|SUPERIORITY_OR_OTHER||Regression coefficient|-0.24||||0.359|TWO_SIDED|95.0|-0.76|0.28||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.28|-0.76|0.359
71687262|NCT00482170|142891565|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.693|TWO_SIDED|95.0|-0.08|0.12|||Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.12|-0.08|0.693
71687263|NCT00482170|142891566|SUPERIORITY_OR_OTHER||Regression coefficient|0.22||||0.17|TWO_SIDED|95.0|-0.09|0.53||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.53|-0.09|0.170
71687264|NCT00482170|142891567|SUPERIORITY_OR_OTHER||Regression coefficient|0.02||||0.211|TWO_SIDED|95.0|-0.01|0.04||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.04|-0.01|0.211
71687265|NCT00482170|142891568|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.045|TWO_SIDED|95.0|0.0|0.18||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.18|0.00|0.045
71687266|NCT00482170|142891569|SUPERIORITY_OR_OTHER||Regression coefficient|-0.01||||0.913|TWO_SIDED|95.0|-0.12|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.11|-0.12|0.913
71687267|NCT00482170|142891570|SUPERIORITY_OR_OTHER||Regression coefficient|0.0||||0.968|TWO_SIDED|95.0|-0.17|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.||0.17|-0.17|0.968
71687268|NCT00482170|142891571|SUPERIORITY_OR_OTHER||Regression coefficient|-0.15||||0.531|TWO_SIDED|95.0|-0.61|0.32||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).||0.32|-0.61|0.531
71687269|NCT00482170|142891571|SUPERIORITY_OR_OTHER||Regression coefficient|0.44||||0.061|TWO_SIDED|95.0|-0.02|0.9||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).||0.90|-0.02|0.061
71687270|NCT00482170|142891572|SUPERIORITY_OR_OTHER||Regression coefficient|-0.73||||0.759|TWO_SIDED|95.0|-5.37|3.92||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||3.92|-5.37|0.759
71687271|NCT00482170|142891573|SUPERIORITY_OR_OTHER||Regression coefficient|0.09||||0.713|TWO_SIDED|95.0|-0.37|0.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).||0.55|-0.37|0.713
71687272|NCT00482170|142891574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.001|TWO_SIDED|95.0|1.63|3.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.49|1.63|<0.001
71687273|NCT00482170|142891574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.61|3.67||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.67|1.61|<0.001
71687274|NCT00482170|142891574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.74|||<|0.001|TWO_SIDED|95.0|1.78|4.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.21|1.78|<0.001
71687275|NCT00482170|142891574|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51|||<|0.001|TWO_SIDED|95.0|1.66|3.8||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.80|1.66|<0.001
71882889|NCT01964352|143284911|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.031|STANDARD_ERROR_OF_MEAN|0.018||0.0872|TWO_SIDED|95.0|-0.005|0.067|||Mixed Effects Model for Repeated Measure|||||0.067|-0.005|0.0872
71882890|NCT01964352|143284912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.162|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.0124|0.2|||Mixed Effects Model for Repeated Measure|||||0.200|0.0124|<0.0001
71882891|NCT01964352|143284912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.028|STANDARD_ERROR_OF_MEAN|0.019||0.1381|TWO_SIDED|95.0|-0.009|0.066|||Mixed Effects Model for Repeated Measure|||||0.066|-0.009|0.1381
71687276|NCT00482170|142891575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.88||||0.004|TWO_SIDED|95.0|1.22|2.89||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.89|1.22|0.004
71687277|NCT00482170|142891575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.017|TWO_SIDED|95.0|1.1|2.72||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.72|1.10|0.017
71687278|NCT00482170|142891575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.47|3.73||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.73|1.47|<0.001
71687279|NCT00482170|142891575|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.06||||0.001|TWO_SIDED|95.0|1.32|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.21|1.32|0.001
71687280|NCT00482170|142891576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.025|TWO_SIDED|95.0|1.07|2.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.64|1.07|0.025
71687281|NCT00482170|142891576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.936|TWO_SIDED|95.0|0.63|1.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.64|0.63|0.936
71687282|NCT00482170|142891576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.42|TWO_SIDED|95.0|0.75|1.99||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.99|0.75|0.420
71687283|NCT00482170|142891576|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.625|TWO_SIDED|95.0|0.71|1.79||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.79|0.71|0.625
71687284|NCT00482170|142891577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.21|TWO_SIDED|95.0|0.86|1.94||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.94|0.86|0.210
71687285|NCT00482170|142891577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.227|TWO_SIDED|95.0|0.85|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.85|0.227
71880387|NCT00884273|143280279|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Final Values)|2.37||||0.36|TWO_SIDED|95.0|-2.78|7.52||FAS.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.52|-2.78|0.36
71880388|NCT00884273|143280288|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Net)|2.24||||0.41|TWO_SIDED|95.0|-3.1|7.58||PP.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.||7.58|-3.10|0.41
71880389|NCT03710486|143280300|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.13202|TWO_SIDED|95.0|0.32|1.16|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by propensity scores inverse probability treatment weighting (PS-IPTW).|Estimated with a logistic regression adjusted by PS-IPTW.|||1.16|0.32|=0.13202
71687286|NCT00482170|142891577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.22|TWO_SIDED|95.0|0.84|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.08|0.84|0.220
71880390|NCT03710486|143280301|SUPERIORITY||Odds Ratio (OR)|1.18|||=|0.5861|TWO_SIDED|95.0|0.65|2.13|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.13|0.65|=0.5861
71880391|NCT03710486|143280304|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.1648|TWO_SIDED|95.0|0.35|1.19|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.19|0.35|=0.1648
71880392|NCT03710486|143280305|SUPERIORITY||Odds Ratio (OR)|0.66|||=|0.1732|TWO_SIDED|95.0|0.36|1.2|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.20|0.36|=0.1732
71880393|NCT03710486|143280308|SUPERIORITY||||||=|0.2011|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||CD: Vedolizumab Versus Other Biological||||=0.2011
71880394|NCT03710486|143280309|SUPERIORITY||||||=|0.6939|||||||Log Rank Test Adjusted by PS-IPTW|p-value was estimated with Log Rank test adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.||||||=0.6939
71880395|NCT03710486|143280310|SUPERIORITY||Odds Ratio (OR)|0.29|||=|0.0071|TWO_SIDED|95.0|0.12|0.71|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.71|0.12|=0.0071
71880396|NCT03710486|143280311|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.4809|TWO_SIDED|95.0|0.64|2.55|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.55|0.64|=0.4809
71880397|NCT03710486|143280312|SUPERIORITY||Odds Ratio (OR)|1.05|||=|0.915|TWO_SIDED|95.0|0.46|2.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.36|0.46|=0.9150
71880398|NCT03710486|143280313|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.7254|TWO_SIDED|95.0|0.56|2.28|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.28|0.56|=0.7254
71880399|NCT03710486|143280314|SUPERIORITY||Odds Ratio (OR)|0.34|||=|0.0051|TWO_SIDED|95.0|0.16|0.72|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.72|0.16|=0.0051
71880400|NCT03710486|143280315|SUPERIORITY||Odds Ratio (OR)|0.53|||=|0.0653|TWO_SIDED|95.0|0.27|1.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.04|0.27|=0.0653
71920452|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.29|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|6.389|12.19|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||12.190|6.389|<0.001
71687287|NCT00482170|142891577|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.249|TWO_SIDED|95.0|0.84|2.0||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.00|0.84|0.249
71880401|NCT03710486|143280316|SUPERIORITY||Odds Ratio (OR)|0.9|||=|0.7629|TWO_SIDED|95.0|0.47|1.74|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.74|0.47|=0.7629
71920453|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|7.255|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|4.336|10.175|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||10.175|4.336|<0.001
71687288|NCT00482170|142891578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.48|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.21|1.48|<0.001
71687289|NCT00482170|142891578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.62|3.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.62|1.62|<0.001
71687290|NCT00482170|142891578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35|||<|0.001|TWO_SIDED|95.0|1.58|3.51||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.51|1.58|<0.001
71687291|NCT00482170|142891578|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.64|3.59||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.59|1.64|<0.001
71687292|NCT00482170|142891579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.34|||<|0.001|TWO_SIDED|95.0|1.5|3.65||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.65|1.50|<0.001
71687293|NCT00482170|142891579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.96|||<|0.001|TWO_SIDED|95.0|1.83|4.77||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.77|1.83|<0.001
71687294|NCT00482170|142891579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.58|||<|0.001|TWO_SIDED|95.0|1.62|4.12||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||4.12|1.62|<0.001
71687295|NCT00482170|142891579|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45|||<|0.001|TWO_SIDED|95.0|1.55|3.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.86|1.55|<0.001
71687296|NCT00482170|142891580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.681|TWO_SIDED|95.0|0.73|1.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.62|0.73|0.681
71687297|NCT00482170|142891580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.947|TWO_SIDED|95.0|0.67|1.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.54|0.67|0.947
71687298|NCT00482170|142891580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.604|TWO_SIDED|95.0|0.59|1.36||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.36|0.59|0.604
71687299|NCT00482170|142891580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.43|TWO_SIDED|95.0|0.57|1.27||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.27|0.57|0.430
71687300|NCT00482170|142891581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.072|TWO_SIDED|95.0|0.48|1.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.03|0.48|0.072
71687301|NCT00482170|142891581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.205|TWO_SIDED|95.0|0.86|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.86|0.205
71687302|NCT00482170|142891581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.434|TWO_SIDED|95.0|0.78|1.78||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.78|0.78|0.434
71687303|NCT00482170|142891581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.857|TWO_SIDED|95.0|0.69|1.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.55|0.69|0.857
71687304|NCT00482170|142891582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.837|TWO_SIDED|95.0|0.7|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.70|0.837
71687305|NCT00482170|142891582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.172|TWO_SIDED|95.0|0.87|2.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.15|0.87|0.172
71687306|NCT00482170|142891582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.096|TWO_SIDED|95.0|0.94|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.24|0.94|0.096
71687307|NCT00482170|142891582|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.164|TWO_SIDED|95.0|0.88|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.08|0.88|0.164
71687308|NCT00482170|142891583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.356|TWO_SIDED|95.0|0.83|1.69||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.69|0.83|0.356
71687309|NCT00482170|142891583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.737|TWO_SIDED|95.0|0.73|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.56|0.73|0.737
71687310|NCT00482170|142891583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.156|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.156
71687311|NCT00482170|142891583|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.29|TWO_SIDED|95.0|0.85|1.76||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.76|0.85|0.290
71687312|NCT00482170|142891584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.065|TWO_SIDED|95.0|0.5|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.02|0.50|0.065
71920454|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|2.228|STANDARD_ERROR_OF_MEAN|1.806||0.11|TWO_SIDED|95.0|-1.361|5.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.818|-1.361|0.110
71920455|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.578|STANDARD_ERROR_OF_MEAN|1.815||0.001|TWO_SIDED|95.0|1.972|9.185|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.185|1.972|0.001
71920456|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.712|STANDARD_ERROR_OF_MEAN|1.789||0.005|TWO_SIDED|95.0|1.156|8.268|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.268|1.156|0.005
71920457|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.888|STANDARD_ERROR_OF_MEAN|2.035||0.002|TWO_SIDED|95.0|1.844|9.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.932|1.844|0.002
71687313|NCT00482170|142891584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.1|TWO_SIDED|95.0|0.5|1.06||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.06|0.50|0.100
71687314|NCT00482170|142891584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.298|TWO_SIDED|95.0|0.54|1.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.21|0.54|0.298
71687315|NCT00482170|142891584|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.148|TWO_SIDED|95.0|0.51|1.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.11|0.51|0.148
71687316|NCT00482170|142891585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.098|TWO_SIDED|95.0|0.94|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.94|0.098
71687317|NCT00482170|142891585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.311|TWO_SIDED|95.0|0.82|1.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.87|0.82|0.311
71687318|NCT00482170|142891585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.376|TWO_SIDED|95.0|0.79|1.85||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.85|0.79|0.376
71687319|NCT00482170|142891585|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.299|TWO_SIDED|95.0|0.83|1.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.86|0.83|0.299
71687320|NCT00482170|142891586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.494|TWO_SIDED|95.0|0.6|1.28||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.28|0.60|0.494
71687321|NCT00482170|142891586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.65||||0.036|TWO_SIDED|95.0|0.44|0.97||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.97|0.44|0.036
71687322|NCT00482170|142891586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.079|TWO_SIDED|95.0|0.45|1.04||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.04|0.45|0.079
71687323|NCT00482170|142891586|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.68||||0.063|TWO_SIDED|95.0|0.46|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.02|0.46|0.063
71880402|NCT03710486|143280317|SUPERIORITY||Odds Ratio (OR)|0.8|||=|0.4895|TWO_SIDED|95.0|0.43|1.5|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.50|0.43|=0.4895
71880403|NCT03710486|143280318|SUPERIORITY||Odds Ratio (OR)|0.76|||=|0.4458|TWO_SIDED|95.0|0.38|1.54|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||1.54|0.38|=0.4458
71880404|NCT03710486|143280319|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.04|0.47|=0.9471
71880405|NCT03710486|143280320|SUPERIORITY||Odds Ratio (OR)|0.42|||=|0.0104|TWO_SIDED|95.0|0.21|0.81|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.81|0.21|=0.0104
71880406|NCT03710486|143280321|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
71880407|NCT03710486|143280322|SUPERIORITY||Odds Ratio (OR)|0.98|||=|0.9471|TWO_SIDED|95.0|0.47|2.04|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|CD Participants||2.04|0.47|=0.9471
71880408|NCT03710486|143280323|SUPERIORITY||Odds Ratio (OR)|0.3|||=|0.0104|TWO_SIDED|95.0|0.12|0.75|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.75|0.12|=0.0104
71880409|NCT03710486|143280324|SUPERIORITY||Odds Ratio (OR)|0.26|||=|0.0011|TWO_SIDED|95.0|0.12|0.59|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.59|0.12|=0.0011
71687324|NCT00482170|142891587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.628|TWO_SIDED|95.0|0.62|1.33||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.33|0.62|0.628
71880410|NCT03710486|143280325|SUPERIORITY||Odds Ratio (OR)|1.28|||=|0.54|TWO_SIDED|95.0|0.59|2.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||2.78|0.59|=0.5400
71687325|NCT00482170|142891587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.203|TWO_SIDED|95.0|0.51|1.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.15|0.51|0.203
71880411|NCT03710486|143280326|SUPERIORITY||Odds Ratio (OR)|1.21|||=|0.8123|TWO_SIDED|95.0|0.26|5.66|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||5.66|0.26|=0.8123
71880412|NCT03710486|143280327|SUPERIORITY||Odds Ratio (OR)|0.22|||=|0.0282|TWO_SIDED|95.0|0.06|0.85|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||0.85|0.06|=0.0282
71880413|NCT03710486|143280328|SUPERIORITY||Odds Ratio (OR)|1.13|||=|0.8584|TWO_SIDED|95.0|0.29|4.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||4.36|0.29|=0.8584
71880414|NCT03710486|143280329|SUPERIORITY||Odds Ratio (OR)|0.95|||=|0.9474|TWO_SIDED|95.0|0.24|3.78|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|Estimated with a logistic regression adjusted by PS-IPTW.|||3.78|0.24|=0.9474
71880415|NCT03710486|143280330|SUPERIORITY||Odds Ratio (OR)|0.73|||=|0.3103|TWO_SIDED|95.0|0.4|1.34|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.34|0.40|=0.3103
71880416|NCT03710486|143280330|SUPERIORITY||Odds Ratio (OR)|0.41|||=|0.0045|TWO_SIDED|95.0|0.22|0.76|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||0.76|0.22|=0.0045
71880417|NCT03710486|143280330|SUPERIORITY||Odds Ratio (OR)|1.19|||=|0.6287|TWO_SIDED|95.0|0.59|2.42|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.42|0.59|=0.6287
71880418|NCT03710486|143280330|SUPERIORITY||Odds Ratio (OR)|0.65|||=|0.2495|TWO_SIDED|95.0|0.31|1.36|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||1.36|0.31|=0.2495
71880419|NCT03710486|143280331|SUPERIORITY||Risk Ratio (RR)|0.89|||=|0.4784|TWO_SIDED|95.0|0.66|1.22|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.22|0.66|=0.4784
71880420|NCT03710486|143280331|SUPERIORITY||Risk Ratio (RR)|0.83|||=|0.2616|TWO_SIDED|95.0|0.6|1.15|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse event||1.15|0.60|=0.2616
71880421|NCT03710486|143280331|SUPERIORITY||Risk Ratio (RR)|2.01|||=|0.0077|TWO_SIDED|95.0|1.2|3.34|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||3.34|1.20|=0.0077
71880422|NCT03710486|143280331|SUPERIORITY||Risk Ratio (RR)|1.3|||=|0.3046|TWO_SIDED|95.0|0.79|2.14|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse event||2.14|0.79|=0.3046
71880423|NCT03710486|143280332|SUPERIORITY||Odds Ratio (OR)|0.54|||=|0.1681|TWO_SIDED|95.0|0.22|1.3|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.30|0.22|=0.1681
71880424|NCT03710486|143280332|SUPERIORITY||Odds Ratio (OR)|0.23|||=|0.0645|TWO_SIDED|95.0|0.05|1.09|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||1.09|0.05|=0.0645
71880425|NCT03710486|143280332|SUPERIORITY||Odds Ratio (OR)|0.38|||=|0.3145|TWO_SIDED|95.0|0.06|2.51|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.51|0.06|=0.3145
71880426|NCT03710486|143280332|SUPERIORITY||Odds Ratio (OR)|1.49|||=|0.8197|TWO_SIDED|95.0|0.05|47.11|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||47.11|0.05|=0.8197
71882892|NCT01964352|143284912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.113|0.188|||Mixed Effects Model for Repeated Measure|||||0.188|0.113|<0.0001
71687326|NCT00482170|142891587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.222|TWO_SIDED|95.0|0.51|1.17||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.17|0.51|0.222
71920458|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.251|STANDARD_ERROR_OF_MEAN|2.062|<|0.001|TWO_SIDED|95.0|5.153|13.349|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.349|5.153|<0.001
71920459|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.264|STANDARD_ERROR_OF_MEAN|2.072||0.006|TWO_SIDED|95.0|1.147|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.380|1.147|0.006
71920460|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.065|STANDARD_ERROR_OF_MEAN|1.843||0.004|TWO_SIDED|95.0|1.402|8.728|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.728|1.402|0.004
71920461|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|5.096|STANDARD_ERROR_OF_MEAN|1.853||0.004|TWO_SIDED|95.0|1.413|8.78|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||8.780|1.413|0.004
71920462|NCT02055976|143362589|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.301|STANDARD_ERROR_OF_MEAN|1.832||0.011|TWO_SIDED|95.0|0.658|7.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.943|0.658|0.011
71920463|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.389|STANDARD_ERROR_OF_MEAN|2.525|<|0.001|TWO_SIDED|95.0|8.373|18.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.405|8.373|<0.001
71920464|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.546|STANDARD_ERROR_OF_MEAN|2.576|<|0.001|TWO_SIDED|95.0|11.43|21.663|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||21.663|11.430|<0.001
71920465|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|13.288|STANDARD_ERROR_OF_MEAN|2.593|<|0.001|TWO_SIDED|95.0|8.137|18.438|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.438|8.137|<0.001
71920466|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|4.112|STANDARD_ERROR_OF_MEAN|2.909||0.081|TWO_SIDED|95.0|-1.671|9.895|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||9.895|-1.671|0.081
71920467|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.56|STANDARD_ERROR_OF_MEAN|2.927|<|0.001|TWO_SIDED|95.0|3.743|15.377|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.377|3.743|<0.001
71920468|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.826|STANDARD_ERROR_OF_MEAN|2.878|<|0.001|TWO_SIDED|95.0|4.103|15.548|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.548|4.103|<0.001
71920469|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.004|STANDARD_ERROR_OF_MEAN|3.326||0.002|TWO_SIDED|95.0|3.395|16.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.612|3.395|0.002
71920470|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|16.252|STANDARD_ERROR_OF_MEAN|3.367|<|0.001|TWO_SIDED|95.0|9.56|22.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.943|9.560|<0.001
71687327|NCT00482170|142891587|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.263|TWO_SIDED|95.0|0.53|1.19||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.19|0.53|0.263
71687328|NCT00482170|142891588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.914|TWO_SIDED|95.0|0.7|1.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.50|0.70|0.914
71687329|NCT00482170|142891588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.827|TWO_SIDED|95.0|0.7|1.57||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.57|0.70|0.827
71687330|NCT00482170|142891588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.712|TWO_SIDED|95.0|0.61|1.4||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.40|0.61|0.712
71687331|NCT00482170|142891588|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.733|TWO_SIDED|95.0|0.62|1.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.39|0.62|0.733
71687332|NCT00482170|142891589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.09|TWO_SIDED|95.0|0.95|1.95||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.95|0.95|0.090
71687333|NCT00482170|142891589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.154|TWO_SIDED|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.91|0.90|0.154
71687334|NCT00482170|142891589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.037|TWO_SIDED|95.0|1.02|2.22||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.22|1.02|0.037
71687335|NCT00482170|142891589|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.028|TWO_SIDED|95.0|1.05|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.24|1.05|0.028
71687336|NCT00482170|142891590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.022|TWO_SIDED|95.0|1.06|2.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.21|1.06|0.022
71687337|NCT00482170|142891590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.005|TWO_SIDED|95.0|1.17|2.41||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.41|1.17|0.005
71687338|NCT00482170|142891590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.076|TWO_SIDED|95.0|0.97|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.03|0.97|0.076
71687339|NCT00482170|142891590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.049|TWO_SIDED|95.0|1.0|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.11|1.00|0.049
71880427|NCT03710486|143280333|SUPERIORITY||Risk Ratio (RR)|0.43|||=|0.0239|TWO_SIDED|95.0|0.2|0.89|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.89|0.20|=0.0239
71880428|NCT03710486|143280333|SUPERIORITY||Risk Ratio (RR)|0.21|||=|0.0373|TWO_SIDED|95.0|0.05|0.91|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Adverse events related to treatment||0.91|0.05|=0.0373
71687340|NCT00482170|142891591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||<|0.001|TWO_SIDED|95.0|1.32|2.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.83|1.32|<0.001
71687341|NCT00482170|142891591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.63|||<|0.001|TWO_SIDED|95.0|1.78|3.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.87|1.78|<0.001
71687342|NCT00482170|142891591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13|||<|0.001|TWO_SIDED|95.0|1.42|3.19||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||3.19|1.42|<0.001
71687343|NCT00482170|142891591|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.001|TWO_SIDED|95.0|1.52|3.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||3.39|1.52|<0.001
71687344|NCT00482170|142891592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.057|TWO_SIDED|95.0|0.99|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.11|0.99|0.057
71687345|NCT00482170|142891592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.151|TWO_SIDED|95.0|0.9|1.96||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.96|0.90|0.151
71687346|NCT00482170|142891592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.024|TWO_SIDED|95.0|1.06|2.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||2.44|1.06|0.024
71687347|NCT00482170|142891592|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.025|TWO_SIDED|95.0|1.06|2.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||2.39|1.06|0.025
71687348|NCT00482170|142891593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.49|0.24|<0.001
71687349|NCT00482170|142891593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.26|||<|0.001|TWO_SIDED|95.0|0.18|0.37||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.37|0.18|<0.001
71687350|NCT00482170|142891593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.45||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.45|0.21|<0.001
71880429|NCT03710486|143280333|SUPERIORITY||Risk Ratio (RR)|0.54|||=|0.426|TWO_SIDED|95.0|0.12|2.49|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||2.49|0.12|=0.4260
71880430|NCT03710486|143280333|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression||The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|Serious adverse events related to treatment||48.44|0.05|=0.8012
71880431|NCT03710486|143280334|SUPERIORITY||Odds Ratio (OR)|0.17|||=|0.0044|TWO_SIDED|95.0|0.05|0.58|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.58|0.05|=0.0044
71880432|NCT03710486|143280334|SUPERIORITY||Odds Ratio (OR)|0.32|||=|0.0215|TWO_SIDED|95.0|0.12|0.84|||Regression, Logistic|p-value was estimated with a logistic regression adjusted by PS-IPTW.|The incidence comparison was estimated by using a logistic regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.84|0.12|=0.0215
71880433|NCT03710486|143280335|SUPERIORITY||Risk Ratio (RR)|0.27|||=|0.0152|TWO_SIDED|95.0|0.1|0.78|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||0.78|0.10|=0.0152
71880434|NCT03710486|143280335|SUPERIORITY||Risk Ratio (RR)|1.56|||=|0.8012|TWO_SIDED|95.0|0.05|48.44|||Poisson Regression|p-value was estimated with a Poisson regression including the following time adjusted by PS-IPTW.|The incidence rate comparison was estimated by using a Poisson regression adjusted by PS-IPTW. Multiple Imputation has been performed to estimate PS-IPTW.|||48.44|0.05|=0.8012
71880435|NCT01147744|143280340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.056||||0.326|TWO_SIDED|95.0|-0.06|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.06|0.326
71880436|NCT01147744|143280340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.104||||0.066|TWO_SIDED|95.0|-0.01|0.22||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.22|-0.01|0.066
71880437|NCT01147744|143280340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.069||||0.224|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.224
71880438|NCT01147744|143280340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.062||||0.271|TWO_SIDED|95.0|-0.05|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.17|-0.05|0.271
71880439|NCT01147744|143280340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.189|||<|0.001|TWO_SIDED|95.0|0.08|0.3||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.30|0.08|<0.001
71880440|NCT01147744|143280340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.22|TWO_SIDED|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.||||0.18|-0.04|0.220
71882893|NCT01964352|143284912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.017|STANDARD_ERROR_OF_MEAN|0.019||0.3872|TWO_SIDED|95.0|-0.021|0.054|||Mixed Effects Model for Repeated Measure|||||0.054|-0.021|0.3872
71882894|NCT01964352|143284912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.096|0.172|||Mixed Effects Model for Repeated Measure|||||0.172|0.096|<0.0001
71882895|NCT01964352|143284912|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.012|STANDARD_ERROR_OF_MEAN|0.019||0.5333|TWO_SIDED|95.0|-0.025|0.049|||Mixed Effects Model for Repeated Measure|||||0.049|-0.025|0.5333
71882896|NCT01964352|143284913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.894|STANDARD_ERROR_OF_MEAN|1.024|<|0.0001|TWO_SIDED|95.0|-6.904|-2.884|||Mixed Effects Model for Repeated Measure|||||-2.884|-6.904|<0.0001
71882897|NCT01964352|143284913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.493|STANDARD_ERROR_OF_MEAN|1.009||0.0136|TWO_SIDED|95.0|-4.473|-0.513|||Mixed Effects Model for Repeated Measure|||||-0.513|-4.473|0.0136
71882898|NCT01964352|143284913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.122|STANDARD_ERROR_OF_MEAN|1.023|<|0.0001|TWO_SIDED|95.0|-6.129|-2.114|||Mixed Effects Model for Repeated Measure|||||-2.114|-6.129|<0.0001
71882899|NCT01964352|143284913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.721|STANDARD_ERROR_OF_MEAN|1.008||0.088|TWO_SIDED|95.0|-3.698|0.256|||Mixed Effects Model for Repeated Measure|||||0.256|-3.698|0.0880
71882900|NCT01964352|143284913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.401|STANDARD_ERROR_OF_MEAN|1.029||0.0198|TWO_SIDED|95.0|-4.419|-0.382|||Mixed Effects Model for Repeated Measure|||||-0.382|-4.419|0.0198
71882901|NCT01964352|143284913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.772|STANDARD_ERROR_OF_MEAN|1.003||0.4415|TWO_SIDED|95.0|-2.741|1.196|||Mixed Effects Model for Repeated Measure|||||1.196|-2.741|0.4415
71882902|NCT01964352|143284914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.157|0.282|||Mixed Effects Model for Repeated Measure|||||0.282|0.157|<0.0001
71882903|NCT01964352|143284914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.032||0.5052|TWO_SIDED|95.0|-0.041|0.084|||Mixed Effects Model for Repeated Measure|||||0.084|-0.041|0.5052
71882904|NCT01964352|143284914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.208|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.146|0.271|||Mixed Effects Model for Repeated Measure|||||0.271|0.146|<0.0001
71882905|NCT01964352|143284914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7566|TWO_SIDED|95.0|-0.052|0.072|||Mixed Effects Model for Repeated Measure|||||0.072|-0.052|0.7566
71882906|NCT01964352|143284914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.032|<|0.0001|TWO_SIDED|95.0|0.136|0.261|||Mixed Effects Model for Repeated Measure|||||0.261|0.136|<0.0001
71882907|NCT01964352|143284914|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.032||0.7199|TWO_SIDED|95.0|-0.051|0.073|||Mixed Effects Model for Repeated Measure|||||0.073|-0.051|0.7199
71880441|NCT01147744|143280341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.385||||0.932|TWO_SIDED|95.0|-9.25|8.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||8.48|-9.25|0.932
71880442|NCT01147744|143280341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.367||||0.762|TWO_SIDED|95.0|-7.5|10.23|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.23|-7.50|0.762
71880443|NCT01147744|143280341|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.798||||0.689|TWO_SIDED|95.0|-10.62|7.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||7.03|-10.62|0.689
71880444|NCT01147744|143280341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.321||||0.605|TWO_SIDED|95.0|-6.49|11.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.13|-6.49|0.605
71920471|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.571|STANDARD_ERROR_OF_MEAN|3.384||0.003|TWO_SIDED|95.0|2.847|16.295|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.295|2.847|0.003
71920472|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|9.029|STANDARD_ERROR_OF_MEAN|2.858||0.001|TWO_SIDED|95.0|3.348|14.71|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.710|3.348|0.001
71920473|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.543|STANDARD_ERROR_OF_MEAN|2.876||0.002|TWO_SIDED|95.0|2.827|14.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.260|2.827|0.002
71920474|NCT02055976|143362590|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.898|STANDARD_ERROR_OF_MEAN|2.84||0.001|TWO_SIDED|95.0|3.252|14.544|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||14.544|3.252|0.001
71920475|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-7.462|STANDARD_ERROR_OF_MEAN|1.434|<|0.001|TWO_SIDED|95.0|-10.311|-4.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-4.614|-10.311|<0.001
71880445|NCT01147744|143280341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.46||||0.584|TWO_SIDED|95.0|-6.36|11.28|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||11.28|-6.36|0.584
71880446|NCT01147744|143280341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.529||||0.907|TWO_SIDED|95.0|-8.4|9.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||9.45|-8.40|0.907
71920476|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.693|STANDARD_ERROR_OF_MEAN|1.469|<|0.001|TWO_SIDED|95.0|-9.61|-3.776|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-3.776|-9.610|<0.001
71920477|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.755|STANDARD_ERROR_OF_MEAN|1.479|<|0.001|TWO_SIDED|95.0|-11.692|-5.817|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.817|-11.692|<0.001
71920478|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.072|STANDARD_ERROR_OF_MEAN|1.773||0.484|TWO_SIDED|95.0|-3.596|3.451|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.451|-3.596|0.484
71920479|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.701|STANDARD_ERROR_OF_MEAN|1.793||0.173|TWO_SIDED|95.0|-5.264|1.862|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.862|-5.264|0.173
71920480|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.953|STANDARD_ERROR_OF_MEAN|1.761||0.135|TWO_SIDED|95.0|-5.452|1.546|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.546|-5.452|0.135
71920481|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.447|STANDARD_ERROR_OF_MEAN|2.406||0.034|TWO_SIDED|95.0|-9.23|0.335|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.335|-9.230|0.034
71880447|NCT01147744|143280342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.463||||0.753|TWO_SIDED|95.0|-7.65|10.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||10.58|-7.65|0.753
71920482|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.764|STANDARD_ERROR_OF_MEAN|2.442||0.003|TWO_SIDED|95.0|-11.617|-1.91|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.910|-11.617|0.003
71920483|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.951|STANDARD_ERROR_OF_MEAN|2.458||0.009|TWO_SIDED|95.0|-10.836|-1.066|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.066|-10.836|0.009
71687351|NCT00482170|142891593|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.23|0.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.47|0.23|<0.001
71880448|NCT01147744|143280342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.75||||0.419|TWO_SIDED|95.0|-5.36|12.87|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.87|-5.36|0.419
71880449|NCT01147744|143280342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.046||||0.51|TWO_SIDED|95.0|-12.12|6.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||6.03|-12.12|0.510
71880450|NCT01147744|143280342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.585||||0.32|TWO_SIDED|95.0|-4.47|13.64|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||13.64|-4.47|0.320
71880451|NCT01147744|143280342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.484||||0.452|TWO_SIDED|95.0|-5.61|12.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||12.58|-5.61|0.452
71880452|NCT01147744|143280342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.615||||0.229|TWO_SIDED|95.0|-3.55|14.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.||||14.78|-3.55|0.229
71880453|NCT01147744|143280343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.169||||0.771|TWO_SIDED|95.0|-6.73|9.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.07|-6.73|0.771
71880454|NCT01147744|143280343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56||||0.257|TWO_SIDED|95.0|-3.33|12.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.45|-3.33|0.257
71880455|NCT01147744|143280343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.326||||0.741|TWO_SIDED|95.0|-6.54|9.19|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||9.19|-6.54|0.741
71880456|NCT01147744|143280343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.083||||0.983|TWO_SIDED|95.0|-7.76|7.93|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.93|-7.76|0.983
71880457|NCT01147744|143280343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.204||||0.041|TWO_SIDED|95.0|0.34|16.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||16.07|0.34|0.041
71880458|NCT01147744|143280343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.891||||0.475|TWO_SIDED|95.0|-5.05|10.83|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.83|-5.05|0.475
71880459|NCT01147744|143280344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.837||||0.838|TWO_SIDED|95.0|-7.22|8.89|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.89|-7.22|0.838
71880460|NCT01147744|143280344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.715||||0.508|TWO_SIDED|95.0|-5.33|10.76|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.76|-5.33|0.508
71920484|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|1.915||0.056|TWO_SIDED|95.0|-6.876|0.736|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.736|-6.876|0.056
71920485|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.557|STANDARD_ERROR_OF_MEAN|1.937||0.095|TWO_SIDED|95.0|-6.408|1.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||1.293|-6.408|0.095
71687352|NCT00482170|142891594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.27|0.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.54|0.27|<0.001
71687353|NCT00482170|142891594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.31|||<|0.001|TWO_SIDED|95.0|0.21|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.21|<0.001
71880461|NCT01147744|143280344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.124||||0.603|TWO_SIDED|95.0|-5.9|10.14|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.14|-5.90|0.603
71880462|NCT01147744|143280344|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|-1.781||||0.662|TWO_SIDED|95.0|-9.78|6.22|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||6.22|-9.78|0.662
71920486|NCT02055976|143362592|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.271|STANDARD_ERROR_OF_MEAN|1.913||0.004|TWO_SIDED|95.0|-9.074|-1.469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.469|-9.074|0.004
71687354|NCT00482170|142891594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.34|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
71687355|NCT00482170|142891594|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||<|0.001|TWO_SIDED|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.50|0.24|<0.001
71880463|NCT01147744|143280344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.949||||0.146|TWO_SIDED|95.0|-2.08|13.98|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.98|-2.08|0.146
71880464|NCT01147744|143280344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.394||||0.191|TWO_SIDED|95.0|-2.69|13.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||13.48|-2.69|0.191
71880465|NCT01147744|143280345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.106||||0.164|TWO_SIDED|95.0|-2.5|14.71|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||14.71|-2.50|0.164
71880466|NCT01147744|143280345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.106||||0.349||95.0|-4.49|12.7|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.70|-4.49|0.349
71880467|NCT01147744|143280345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.148||||0.623|TWO_SIDED|95.0|-6.42|10.72|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.72|-6.42|0.623
71880468|NCT01147744|143280345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.713||||0.694|TWO_SIDED|95.0|-6.84|10.26|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.26|-6.84|0.694
71880469|NCT01147744|143280345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.592||||0.028|TWO_SIDED|95.0|1.03|18.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||18.15|1.03|0.028
71880470|NCT01147744|143280345|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.75||||0.125|TWO_SIDED|95.0|-1.89|15.38|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.38|-1.89|0.125
71880471|NCT01147744|143280346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.346||||0.585|TWO_SIDED|95.0|-6.09|10.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||10.78|-6.09|0.585
71880472|NCT01147744|143280346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.431||||0.92|TWO_SIDED|95.0|-8.0|8.86|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||8.86|-8.00|0.920
71880473|NCT01147744|143280346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.702||||0.528|TWO_SIDED|95.0|-5.7|11.11|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||11.11|-5.70|0.528
71880474|NCT01147744|143280346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.218||||0.776|TWO_SIDED|95.0|-9.6|7.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||7.17|-9.60|0.776
71920487|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.88|STANDARD_ERROR_OF_MEAN|7.071|<|0.001|TWO_SIDED|95.0|-45.925|-17.836|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.836|-45.925|<0.001
71687356|NCT00482170|142891595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33|||<|0.001|TWO_SIDED|95.0|0.24|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.24|<0.001
71687357|NCT00482170|142891595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32|||<|0.001|TWO_SIDED|95.0|0.22|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.46|0.22|<0.001
71687358|NCT00482170|142891595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.38|||<|0.001|TWO_SIDED|95.0|0.26|0.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||0.56|0.26|<0.001
71687359|NCT00482170|142891595|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.41|||<|0.001|TWO_SIDED|95.0|0.28|0.58||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||0.58|0.28|<0.001
71687360|NCT00482170|142891596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.47|TWO_SIDED|95.0|0.6|1.26||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.26|0.60|0.470
71687361|NCT00482170|142891596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.325|TWO_SIDED|95.0|0.57|1.2||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.20|0.57|0.325
71687362|NCT00482170|142891596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.197|TWO_SIDED|95.0|0.55|1.13||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.||1.13|0.55|0.197
71880475|NCT01147744|143280346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.49||||0.081|TWO_SIDED|95.0|-0.92|15.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||15.90|-0.92|0.081
71880476|NCT01147744|143280346|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.611||||0.403|TWO_SIDED|95.0|-4.87|12.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||12.09|-4.87|0.403
71687363|NCT00482170|142891596|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.212|TWO_SIDED|95.0|0.56|1.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.||1.14|0.56|0.212
71687364|NCT00482170|142891597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.35||0.515|TWO_SIDED|95.0|-0.91|0.46||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.||0.46|-0.91|0.515
71687365|NCT00482170|142891597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.34||0.842|TWO_SIDED|95.0|-0.74|0.6||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.60|-0.74|0.842
71687366|NCT00482170|142891597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.33||0.928|TWO_SIDED|95.0|-0.67|0.61||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.||0.61|-0.67|0.928
71687367|NCT00482170|142891597|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.32||0.974|TWO_SIDED|95.0|-0.62|0.64||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Last observation: ANOVA method was used for the analysis.||0.64|-0.62|0.974
71880477|NCT01147744|143280347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.005||||0.951|TWO_SIDED|95.0|-0.17|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.17|0.951
71880478|NCT01147744|143280347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.166||||0.043|TWO_SIDED|95.0|-0.33|-0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.01|-0.33|0.043
71880479|NCT01147744|143280347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.028||||0.734|TWO_SIDED|95.0|-0.19|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.19|0.734
71880480|NCT01147744|143280347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.003||||0.972|TWO_SIDED|95.0|-0.16|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.16|0.972
71880481|NCT01147744|143280347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.097||||0.238|TWO_SIDED|95.0|-0.26|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.26|0.238
71687368|NCT00482170|142891598|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.||||0.030
71880482|NCT01147744|143280347|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.075||||0.36|TWO_SIDED|95.0|-0.24|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.24|0.360
71880483|NCT01147744|143280348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.028||||0.692|TWO_SIDED|95.0|-0.11|0.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.17|-0.11|0.692
71880484|NCT01147744|143280348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.096||||0.176|TWO_SIDED|95.0|-0.24|0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.04|-0.24|0.176
71880485|NCT01147744|143280348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.021||||0.768|TWO_SIDED|95.0|-0.16|0.12|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.12|-0.16|0.768
71880486|NCT01147744|143280348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.887|TWO_SIDED|95.0|-0.13|0.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.15|-0.13|0.887
71880487|NCT01147744|143280348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.051||||0.471|TWO_SIDED|95.0|-0.19|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.19|0.471
71880488|NCT01147744|143280348|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.083||||0.248|TWO_SIDED|95.0|-0.22|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.22|0.248
71920488|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.187|STANDARD_ERROR_OF_MEAN|7.242|<|0.001|TWO_SIDED|95.0|-43.571|-14.803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.803|-43.571|<0.001
71880489|NCT01147744|143280349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.131||||0.209|TWO_SIDED|95.0|-0.33|0.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.07|-0.33|0.209
71880490|NCT01147744|143280349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.264||||0.011|TWO_SIDED|95.0|-0.47|-0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.06|-0.47|0.011
71880491|NCT01147744|143280349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.076||||0.464|TWO_SIDED|95.0|-0.28|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.13|-0.28|0.464
71880492|NCT01147744|143280349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.045||||0.662|TWO_SIDED|95.0|-0.25|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.16|-0.25|0.662
71687369|NCT00482170|142891598|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.||||0.010
71880493|NCT01147744|143280349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.245||||0.018|TWO_SIDED|95.0|-0.45|-0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.04|-0.45|0.018
71880494|NCT01147744|143280349|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.207||||0.047|TWO_SIDED|95.0|-0.41|0.0|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||-0.00|-0.41|0.047
71687370|NCT00482170|142891599|SUPERIORITY_OR_OTHER|||||||0.984||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.984
71880495|NCT01147744|143280350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.098||||0.3|TWO_SIDED|95.0|-0.28|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.09|-0.28|0.300
71880496|NCT01147744|143280350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.138||||0.145|TWO_SIDED|95.0|-0.32|0.05|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.05|-0.32|0.145
71880497|NCT01147744|143280350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.123||||0.19|TWO_SIDED|95.0|-0.31|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.06|-0.31|0.190
71880498|NCT01147744|143280350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.002||||0.98|TWO_SIDED|95.0|-0.19|0.18|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.18|-0.19|0.980
71880499|NCT01147744|143280350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.171||||0.07|TWO_SIDED|95.0|-0.36|0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.01|-0.36|0.070
71880500|NCT01147744|143280350|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.158||||0.095|TWO_SIDED|95.0|-0.34|0.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.||||0.03|-0.34|0.095
71880501|NCT01147744|143280351|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71880502|NCT01147744|143280351|SUPERIORITY_OR_OTHER|||||||0.814|||||||Fisher Exact|||||||0.814
71920489|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-39.657|STANDARD_ERROR_OF_MEAN|7.29|<|0.001|TWO_SIDED|95.0|-54.136|-25.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-25.178|-54.136|<0.001
71687371|NCT00482170|142891599|SUPERIORITY_OR_OTHER|||||||0.549||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.549
71687372|NCT00482170|142891600|SUPERIORITY_OR_OTHER|||||||0.158||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.158
71687373|NCT00482170|142891600|SUPERIORITY_OR_OTHER|||||||0.808||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.808
71687374|NCT00482170|142891601|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.||||0.029
71687375|NCT00482170|142891601|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
71687376|NCT00482170|142891601|SUPERIORITY_OR_OTHER|||||||0.411||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.||||0.411
71880503|NCT01147744|143280351|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.000
71880504|NCT01147744|143280351|SUPERIORITY_OR_OTHER|||||||0.828|||||||Fisher Exact|||||||0.828
71880505|NCT01147744|143280351|SUPERIORITY_OR_OTHER|||||||0.477|||||||Fisher Exact|||||||0.477
71880506|NCT01147744|143280351|SUPERIORITY_OR_OTHER|||||||0.46|||||||Fisher Exact|||||||0.460
71880507|NCT03302975|143280373|SUPERIORITY|||||||0.001|TWO_SIDED|95.0|||||ANOVA|||||||0.001
71880508|NCT00807742|143280380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.606|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.606
71880509|NCT00807742|143280381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.29|TWO_SIDED|95.0|0.57|2.63|||Chi-squared|||||2.63|0.57|.290
71880510|NCT00807742|143280382|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.32|TWO_SIDED|95.0|0.49|8.23|||Chi-squared|||||8.23|0.49|.32
71880511|NCT00807742|143280383|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.08||||0.298|TWO_SIDED|95.0|0.51|8.45|||Chi-squared|||||8.45|0.51|.298
71687377|NCT00482170|142891601|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.||||0.005
71687378|NCT00482170|142891602|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.039
71687379|NCT00482170|142891602|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.006
71687380|NCT00482170|142891603|SUPERIORITY_OR_OTHER|||||||0.752||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.752
71687381|NCT00482170|142891603|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.700
71687382|NCT00482170|142891604|SUPERIORITY_OR_OTHER|||||||0.697||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.697
71687383|NCT00482170|142891604|SUPERIORITY_OR_OTHER|||||||0.159||95.0|||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.159
71687384|NCT00482170|142891605|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.004
71880512|NCT00807742|143280384|SUPERIORITY||Effect Size d|-0.49|||<|0.001|TWO_SIDED|95.0|-0.71|-0.27|||t-test, 2 sided|||||-0.27|-0.71|<.001
71880513|NCT00807742|143280385|SUPERIORITY||Effect Size d|-0.15||||0.199|TWO_SIDED|95.0|-0.38|0.08|||t-test, 2 sided|||||0.08|-0.38|.199
71880514|NCT00807742|143280386|SUPERIORITY||Effect Size d|-0.12||||0.148|TWO_SIDED|95.0|-0.57|0.33|||t-test, 2 sided|||||0.33|-.57|.148
71880515|NCT00807742|143280387|SUPERIORITY||Effect Size d|-0.15||||0.249|TWO_SIDED|95.0|-0.4|0.11|||t-test, 2 sided|||||0.11|-0.40|.249
71880516|NCT00807742|143280388|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.402|TWO_SIDED|95.0|0.59|3.72|||Chi-squared|||||3.72|0.59|0.402
71880517|NCT00807742|143280389|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.772|TWO_SIDED|95.0|0.49|1.7|||Chi-squared|||||1.70|0.49|.772
71880518|NCT00807742|143280390|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.91|TWO_SIDED|95.0|0.6|1.77|||Chi-squared|||||1.77|0.60|.910
71880519|NCT00807742|143280391|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.812|TWO_SIDED|95.0|0.54|1.62|||Chi-squared|||||1.62|0.54|.812
71880520|NCT00807742|143280392|SUPERIORITY||Odds Ratio (OR)|0.76||||0.49|TWO_SIDED|95.0|0.36|1.65|||Chi-squared|||||1.65|0.36|.490
71880521|NCT00807742|143280393|SUPERIORITY||Odds Ratio (OR)|1.19||||0.511|TWO_SIDED|95.0|0.67|2.06|||Chi-squared|||||2.06|0.67|.511
71880522|NCT00807742|143280394|SUPERIORITY||Odds Ratio (OR)|1.19||||0.499|TWO_SIDED|95.0|0.72|1.97|||Chi-squared|||||1.97|0.72|.499
71880523|NCT00807742|143280395|SUPERIORITY||Odds Ratio (OR)|0.96||||0.876|TWO_SIDED|95.0|0.58|1.6|||Chi-squared|||||1.60|0.58|.876
71880524|NCT00807742|143280396|SUPERIORITY_OR_OTHER||Effect Size d|-0.37||||0.001|TWO_SIDED|95.0|-0.59|-0.15|||t-test, 2 sided|||||-0.15|-0.59|.001
71880525|NCT00807742|143280397|SUPERIORITY_OR_OTHER||Effect Size d|-0.25||||0.069|TWO_SIDED|95.0|-0.46|0.02|||t-test, 2 sided|||||0.02|-0.46|.069
71687385|NCT00482170|142891605|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
71687386|NCT00482170|142891606|SUPERIORITY_OR_OTHER|||||||0.652||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.652
71687387|NCT00482170|142891606|SUPERIORITY_OR_OTHER|||||||0.024||95.0|||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.024
71687388|NCT00482170|142891607|SUPERIORITY_OR_OTHER|||||||0.56||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.560
71687389|NCT00482170|142891607|SUPERIORITY_OR_OTHER|||||||0.474||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.474
71880526|NCT00807742|143280398|SUPERIORITY_OR_OTHER||Effect Size d|-0.16||||0.202|TWO_SIDED|95.0|-0.4|0.08|||t-test, 2 sided|||||0.08|-0.40|.202
71687390|NCT00482170|142891608|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.023
71880527|NCT00807742|143280399|SUPERIORITY_OR_OTHER||Effect Size d|-0.17||||0.199|TWO_SIDED|95.0|-0.42|0.09|||t-test, 2 sided|||||0.09|-0.42|.199
71687391|NCT00482170|142891608|SUPERIORITY_OR_OTHER|||||||0.089||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.089
71880528|NCT00492752|143280400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6783||||0.014144||95.0|0.4962|0.9272|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||0.9272|0.4962|0.014144
71880529|NCT00492752|143280400|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6208||||0.003464||95.0|0.4498|0.8568|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.8568|0.4498|0.003464
71920490|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-4.681|STANDARD_ERROR_OF_MEAN|13.601||0.366|TWO_SIDED|95.0|-31.713|22.35|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||22.350|-31.713|0.366
71920491|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|10.227|STANDARD_ERROR_OF_MEAN|13.586||0.773|TWO_SIDED|95.0|-16.774|37.228|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||37.228|-16.774|0.773
71687392|NCT00482170|142891609|SUPERIORITY_OR_OTHER|||||||0.494||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.494
71687393|NCT00482170|142891609|SUPERIORITY_OR_OTHER|||||||0.782||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.782
71920492|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.646|STANDARD_ERROR_OF_MEAN|13.362||0.422|TWO_SIDED|95.0|-29.206|23.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||23.915|-29.206|0.422
71920493|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-12.911|STANDARD_ERROR_OF_MEAN|10.309||0.107|TWO_SIDED|95.0|-33.411|7.589|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.589|-33.411|0.107
71687394|NCT00482170|142891610|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.||||0.444
71880530|NCT00492752|143280401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9032||||0.497537||95.0|0.6705|1.2165|||Log Rank||Hazard ratio is for Sorafenib vs placebo.|||1.2165|0.6705|0.497537
71880531|NCT00492752|143280401|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8831||||0.437926||95.0|0.6449|1.2093|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||1.2093|0.6449|0.437926
71880532|NCT00492752|143280402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5744||||0.000537||95.0|0.4154|0.7942|||Log Rank||Hazard ratio is for Sorafenib vs placebo|||0.7942|0.4154|0.000537
71880533|NCT00492752|143280402|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5375||||0.00054||95.0|0.3763|0.7677|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo|||0.7677|0.3763|0.000540
71880534|NCT00492752|143280403|SUPERIORITY_OR_OTHER||Disease control rate|0.3533||||||95.0|0.2771|0.4355||||||||0.4355|0.2771|
71880535|NCT00492752|143280403|SUPERIORITY_OR_OTHER||Disease control rate|0.1579||||||95.0|0.0843|0.2596||||||||0.2596|0.0843|
71880536|NCT00492752|143280406|SUPERIORITY_OR_OTHER|||||||0.67|||||||Fisher Exact|based on tumor response rate (CR+PR)||||||0.67
71880537|NCT02258451|143280423|SUPERIORITY||Hazard Ratio (HR)|0.891||||0.4843|TWO_SIDED|80.0|0.72|1.102||1-sided SSE-FS hypotheses were tested using a log-rank test with a 2-sided alpha of 0.2, stratified by the randomization stratification factors.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) for SSE-FS was calculated using Cox Proportional Hazards Model, stratified by the same stratification factors as randomization.|The 1-sided null hypothesis that treatment with radium-223 dichloride does not result in superior SSE-FS to treatment with placebo in participant population was tested against the 1-sided alternative hypothesis that the treatment with radium-223 dichloride results in superior SSE-FS time to treatment the placebo. H0: SSE-FS Radium-223+Exemestane/Everolimus \<= SSE-FS Placebo+Exemestane/Everolimus, versus HA: SSE-FSRadium-223+Exemestane/Everolimus \> SSE-FS Placebo+Exemestane/Everolimus||1.102|0.720|0.4843
71880538|NCT02258451|143280424|SUPERIORITY||Hazard Ratio (HR)|0.968||||0.8438|TWO_SIDED|95.0|0.697|1.343||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.343|0.697|0.8438
71880539|NCT02258451|143280425|SUPERIORITY||Hazard Ratio (HR)|0.962||||0.8811|TWO_SIDED|95.0|0.577|1.604||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.604|0.577|0.8811
71880540|NCT02258451|143280426|SUPERIORITY||Hazard Ratio (HR)|0.928||||0.6537|TWO_SIDED|95.0|0.667|1.289||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|Participants with baseline WPS \> 8 were included in the analysis population but censored at Day 1.||1.289|0.667|0.6537
71880541|NCT02258451|143280427|SUPERIORITY||Hazard Ratio (HR)|0.884||||0.4496|TWO_SIDED|95.0|0.641|1.219||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.219|0.641|0.4496
71880542|NCT02258451|143280428|SUPERIORITY||Hazard Ratio (HR)|0.874||||0.3467|TWO_SIDED|95.0|0.66|1.157||P-value was calculated using a 2-sided log-rank test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Log Rank||The hazard ratio (radium-223 dichloride / placebo) was calculated using Cox Proportional Hazards Model , stratified by the same stratification factors as randomization.|||1.157|0.660|0.3467
71880543|NCT02258451|143280429|SUPERIORITY||Risk Difference (RD)|4.1||||0.556|TWO_SIDED|95.0|-10.2|18.4||P-value was calculated using a 2-sided Cochran-Mantel-Haenszel test stratified by the same stratification factors as randomization. No alpha adjustment for multiplicity was applied.|Cochran-Mantel-Haenszel|||||18.4|-10.2|0.556
71880544|NCT03834519|143280448|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.2616|TWO_SIDED|95.0|0.77|1.14|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in survival assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.14|0.77|0.2616
71880545|NCT03834519|143280449|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.5544|TWO_SIDED|95.0|0.82|1.25|||Log Rank|One-sided p-value based on log-rank test stratified by measurable disease status and prior NHA treatment.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|Treatment difference in rPFS assessed by the stratified log-rank test stratified by measurable disease status and prior NHA treatment.||1.25|0.82|0.5544
71880546|NCT03834519|143280450|OTHER|Treatment difference in TFST|Hazard Ratio (HR)|0.86||||||95.0|0.71|1.03|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.03|0.71|
71880547|NCT03834519|143280451|OTHER|Treatment difference in ORR|Difference in percentage|10.9|||||TWO_SIDED|95.0|4.0|17.1||||||||17.1|4.0|
71880548|NCT03834519|143280453|OTHER|Treatment difference in time to PSA progression|Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.89|1.38|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.38|0.89|
71687395|NCT00482170|142891610|SUPERIORITY_OR_OTHER|||||||0.947||95.0|||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.947
71687396|NCT00482170|142891611|SUPERIORITY_OR_OTHER|||||||0.787||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.787
71687397|NCT00482170|142891611|SUPERIORITY_OR_OTHER|||||||0.379||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.379
71880549|NCT03834519|143280454|OTHER|Treatment difference in SSRE|Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.38|0.78|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||0.78|0.38|
71880550|NCT03834519|143280455|OTHER|Treatment difference in time to radiographic soft tissue progression|Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.62|1.0|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.00|0.62|
71880551|NCT03834519|143280456|OTHER|Treatment difference in TTPE|Hazard Ratio (HR)|0.95||||0.3643|TWO_SIDED|95.0|0.72|1.26|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by measurable disease status and prior NHA treatment.|||1.26|0.72|0.3643
71880552|NCT02958007|143280503|SUPERIORITY|||||||0.544|||||||t-test, 2 sided|||||||0.544
71687398|NCT00482170|142891611|SUPERIORITY_OR_OTHER|||||||0.098||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.||||0.098
71880553|NCT01484977|143280504|SUPERIORITY_OR_OTHER||Retention Rate|73.3|||||TWO_SIDED|95.0|65.42|81.25||||||"Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.~The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.~This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation."||81.25|65.42|
71880554|NCT00495820|143280505|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71880555|NCT00495820|143280506|SUPERIORITY_OR_OTHER||||||=|0.01|||||||Mixed Models Analysis|||||||=0.01
71880556|NCT00346073|143280525|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.43|||||TWO_SIDED|95.0|-1.47|0.84||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-diphtheria (anti-D) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.84|-1.47|
71882908|NCT01964352|143284915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.052|STANDARD_ERROR_OF_MEAN|0.273|<|0.0001|TWO_SIDED|95.0|1.516|2.588|||Mixed Effects Model for Repeated Measure|||||2.588|1.516|<0.0001
71882909|NCT01964352|143284915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.607|STANDARD_ERROR_OF_MEAN|0.27||0.0246|TWO_SIDED|95.0|0.078|1.137|||Mixed Effects Model for Repeated Measure|||||1.137|0.078|0.0246
71882910|NCT01964352|143284915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.952|STANDARD_ERROR_OF_MEAN|0.272|<|0.0001|TWO_SIDED|95.0|1.417|2.487|||Mixed Effects Model for Repeated Measure|||||2.487|1.417|<0.0001
71882911|NCT01964352|143284915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.507|STANDARD_ERROR_OF_MEAN|0.269||0.0599|TWO_SIDED|95.0|-0.021|1.035|||Mixed Effects Model for Repeated Measure|||||1.035|-0.021|0.0599
71882912|NCT01964352|143284915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.445|STANDARD_ERROR_OF_MEAN|0.274|<|0.0001|TWO_SIDED|95.0|0.907|1.983|||Mixed Effects Model for Repeated Measure|||||1.983|0.907|<0.0001
71882913|NCT01964352|143284915|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.268||0.7081|TWO_SIDED|95.0|-0.425|0.626|||Mixed Effects Model for Repeated Measure|||||0.626|-0.425|0.7081
71882914|NCT01964352|143284916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.457|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.39|0.524|||Mixed Effects Model for Repeated Measure|||||0.524|0.390|<0.0001
71882915|NCT01964352|143284916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.095|0.225|||Mixed Effects Model for Repeated Measure|||||0.225|0.095|<0.0001
71882916|NCT01964352|143284916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.398|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001|TWO_SIDED|95.0|0.331|0.465|||Mixed Effects Model for Repeated Measure|||||0.465|0.331|<0.0001
71882917|NCT01964352|143284916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.101|STANDARD_ERROR_OF_MEAN|0.033||0.0023|TWO_SIDED|95.0|0.036|0.165|||Mixed Effects Model for Repeated Measure|||||0.165|0.036|0.0023
71882918|NCT01964352|143284916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.297|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001|TWO_SIDED|95.0|0.229|0.365|||Mixed Effects Model for Repeated Measure|||||0.365|0.229|<0.0001
71882919|NCT01964352|143284916|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.033||0.0701|TWO_SIDED|95.0|-0.005|0.123|||Mixed Effects Model for Repeated Measure|||||0.123|-0.005|0.0701
71882920|NCT03787472|143284917|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|Least-Square Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|2.98|||TWO_SIDED|95.0|-5.5|6.6|||Linear Mixed Model|The Kenward and Roger method was used for the calculation of the denominator of degrees of freedom.|Mean difference was calculated as Test - Control|||6.6|-5.5|
71882921|NCT03787472|143284918|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.008|STANDARD_ERROR_OF_MEAN|0.0166|||TWO_SIDED|95.0|-0.025|0.041|||Linear Mixed Model||Mean difference was calculated as Test - Control|Distance Standard High Contrast Bright||0.041|-0.025|
71687399|NCT00482170|142891611|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.||||0.166
71882922|NCT03787472|143284918|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|-0.012|STANDARD_ERROR_OF_MEAN|0.0155|||TWO_SIDED|95.0|-0.043|0.019|||Linear Mixed Model||Mean difference was calculated as Test - Control|Intermediate Standard High Contrast Bright||0.019|-0.043|
71687400|NCT00482170|142891612|SUPERIORITY_OR_OTHER|||||||0.535||95.0|||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.||||0.535
71687401|NCT04333225|142891624|OTHER|Other: estimating risk reduction|Risk Ratio (RR)|2.0718||||0.0112|TWO_SIDED|95.0|1.15|3.72|||Chi-squared|||||3.72|1.15|0.0112
71880557|NCT00346073|143280525|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.42|||||TWO_SIDED|95.0|-0.9|0.11||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.||0.11|-0.9|
71880558|NCT00346073|143280526|NON_INFERIORITY|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group - Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-1.04|||||TWO_SIDED|95.0|-1.97|0.0||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 1.0 IU/mL, one month after vaccination.||0|-1.97|
71880559|NCT00346073|143280528|SUPERIORITY||Booster response|77.2|||||TWO_SIDED|95.0|74.9|79.3||||||"Demonstration that anti-PT booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||79.3|74.9|
71880560|NCT00346073|143280528|SUPERIORITY||Booster response|96.9|||||TWO_SIDED|95.0|95.8|97.7||||||"Demonstration that anti-FHA booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||97.7|95.8|
71880561|NCT00346073|143280528|SUPERIORITY||Booster response|93.2|||||TWO_SIDED|95.0|91.8|94.4||||||"Demonstration that anti-PRN booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."||94.4|91.8|
71880562|NCT02603120|143280564|NON_INFERIORITY|A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|0.7|||||TWO_SIDED|95.002|-1.0|2.8|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.8|-1.0|
71880563|NCT02603120|143280564|SUPERIORITY|||||||0.62|||||||Fisher Exact|||||||0.62
71880564|NCT02603120|143280565|NON_INFERIORITY|It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group -ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10%.|Difference in Percentages|-1.4|||||TWO_SIDED|95.002|-5.5|2.6|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|||2.6|-5.5|
71880565|NCT02603120|143280565|SUPERIORITY|||||||0.59|||||||Fisher Exact|||||||.59
71880566|NCT02603120|143280566|OTHER||Difference in least squares means|-35.0||||0.031|TWO_SIDED|95.0|-67.0|-3.0|||ANOVA|||||-3|-67|0.031
71880567|NCT02603120|143280568|OTHER||Difference in least squares means|0.276||||0.33|TWO_SIDED|95.0|-0.275|0.827|||ANOVA|||||0.827|-0.275|0.33
71880568|NCT02603120|143280570|OTHER||Difference in least squares means|-0.143||||0.47|TWO_SIDED|95.0|-0.534|0.248|||ANOVA|||||0.248|-0.534|0.47
71880569|NCT03577730|143280617|OTHER||Median Difference (Final Values)|55.0||||0.092|TWO_SIDED|95.0|-9.0|118.0|||Generalized estimating equations||The median difference (+55) is an estimated difference between groups - rather than the actual difference - based on the pre-specified generalized estimated equations modeling.|||118|-9|0.092
71880570|NCT03577730|143280618|OTHER|||||||0.802|||||||Mixed Models Analysis|||Analysis for visual analog scale scores at rest presented.||||0.802
71880571|NCT03577730|143280619|OTHER|||||||0.32|||||||Mixed Models Analysis|||||||0.320
71880572|NCT03577730|143280620|OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||||||0.670
71687402|NCT04333225|142891625|OTHER|Other: Estimating hazard ratio|Hazard Ratio (HR)|0.35||||0.0105|TWO_SIDED|95.0|0.17|0.75|||Log Rank|||||0.75|0.17|0.0105
71687403|NCT00822328|142891642|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
71880573|NCT03577730|143280621|OTHER|||||||0.595|||||||Fisher Exact|||||||0.595
71880574|NCT03577730|143280622|OTHER|||||||0.985|||||||Fisher Exact|||||||0.985
71880575|NCT03577730|143280623|OTHER|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||||||0.417
71880576|NCT03577730|143280624|OTHER|||||||0.432|||||||Wilcoxon (Mann-Whitney)|||||||0.432
71880577|NCT03577730|143280625|OTHER|||||||0.673|||||||Wilcoxon (Mann-Whitney)|||||||0.673
71880578|NCT03577730|143280626|OTHER|||||||0.058|||||||Chi-squared|||||||0.058
71880579|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.4295|TWO_SIDED|95.0|-1.65|0.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 1||0.70|-1.65|0.4295
71880580|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.0586|TWO_SIDED|95.0|-2.34|0.04|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 1||0.04|-2.34|0.0586
71687404|NCT00822328|142891644|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).||||<0.05
71687405|NCT04399538|142891648|SUPERIORITY||Difference in least square (LS) mean|-52.36|||<|0.0001||80.0|-60.07|-43.17|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-43.17|-60.07|<0.0001
71687406|NCT04399538|142891648|SUPERIORITY||Difference in LS mean|-56.58|||<|0.0001||80.0|-63.88|-47.8|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-47.80|-63.88|<0.0001
71687407|NCT04399538|142891648|SUPERIORITY||Difference in LS mean|-58.8|||<|0.0001||80.0|-65.66|-50.57|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. Relative change was converted to percent change as follows: Percent change = 100\*(RC-1). 80% CI was calculated based on difference in LS mean between groups.||-50.57|-65.66|<0.0001
71687408|NCT04399538|142891648|SUPERIORITY||Difference in LS mean|-45.8||||0.0003||80.0|-55.86|-33.46|||ANCOVA|||Natural log-transformed individual relative change (RC) from baseline to Week 6 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline % liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale.||-33.46|-55.86|0.0003
71687409|NCT01420016|142891656|EQUIVALENCE|The analysis used a time-by-condition mixed model to estimate the annual rate of change in post-index CV risk values by treatment group. The models included fixed effects for study arm (CDS vs. UC), time (years since index), and study-arm-by-time comparing the rate of change in CDS versus UC and a random clinic intercept. The intervention effect was the difference in rate of change in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|Slope Difference (Net)|-2.25|||<|0.05|TWO_SIDED|95.0|-3.45|-1.04||A priori power analysis (power=.80, α2=.05) estimated detectable group difference in CVR at 1 year of \~2-3%, assuming 18 clinics, 1000 patients per clinic (actual 400), 3 CVR per patient (actual 2.3), and ICC=.01-03 (actual .019). p-value calculated.|Mixed Models Analysis||The intervention effect was the difference in annualized rates of change (slope) in CV risk in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P\<0.05).|||-1.04|-3.45|<0.05
71687410|NCT02685072|142891675|SUPERIORITY||Odds Ratio (OR)|0.5818||||0.3253|TWO_SIDED|95.0|0.1968|1.7202|||Chi-squared|degrees of freedom =1|Odds ratio represents odds of smoking abstinence in TPN + progesterone group versus TPN + placebo group|||1.7202|0.1968|0.3253
71687411|NCT02685072|142891676|SUPERIORITY||Odds Ratio (OR)|1.0781||||0.8944|TWO_SIDED|95.0|0.355|3.2744|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 (negative for smoking) in TPN + progesterone versus TPN + placebo groups|||3.2744|0.3550|0.8944
71687412|NCT02685072|142891677|SUPERIORITY||Odds Ratio (OR)|0.7619||||0.662|TWO_SIDED|95.0|0.2247|2.5838|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.5838|0.2247|0.6620
71687413|NCT02685072|142891678|SUPERIORITY||Odds Ratio (OR)|0.913||||0.8661|TWO_SIDED|95.0|0.3171|2.6287|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.6287|0.3171|0.8661
71687414|NCT02685072|142891679|SUPERIORITY||Mean Difference (Final Values)|-9.1|STANDARD_DEVIATION|31.7||0.31|TWO_SIDED|95.0|-27.1|9.0|||t-test, 2 sided||(Placebo + TPN) - (Progesterone + TPN)|||9.0|-27.1|0.31
71687415|NCT02685072|142891680|SUPERIORITY||Mean Difference (Final Values)|0.148||||0.791|TWO_SIDED|95.0|-0.9747|1.2707|||t-test, 2 sided||(placebo + TPN) - (progesterone + TPN)|||1.2707|-0.9747|0.7910
71687416|NCT02685072|142891681|SUPERIORITY||Mean Difference (Final Values)|9.26||||0.0065|TWO_SIDED|95.0|2.71|15.81|||t-test, 2 sided|||||15.81|2.71|0.0065
71880581|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.89||||0.0111|TWO_SIDED|95.0|-3.34|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 2||-0.43|-3.34|0.0111
71687417|NCT02685072|142891692|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO \< 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|.6449
71687418|NCT02685072|142891693|SUPERIORITY||Odds Ratio (OR)|0.7172||||0.6449|TWO_SIDED|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of prolonged abstinence in TPN + progesterone versus TPN + placebo.|||2.9594|0.1738|0.6449
71687419|NCT02717442|142891704|SUPERIORITY||Risk Ratio (RR)|0.658|||=|0.029|TWO_SIDED|95.0|0.453|0.957||Study week was based on each 4-week interval and was modeled as a categorical variable, and an offset for the log of the number of diary entries recorded for each 4-week interval post-baseline was included for each subject.|Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.957|0.453|=0.029
71687420|NCT02717442|142891705|SUPERIORITY||Risk Ratio (RR)|0.59|||=|0.014|TWO_SIDED|95.0|0.388|0.896|||Regression, Linear|||The primary efficacy endpoint was compared between OTO-104 and placebo at the 2-tailed 0.05 alpha level using a generalized Poisson linear mixed model. The model included fixed effects for randomized treatment group, sex, study week, a treatment group by study week interaction, and the count of lead-in period DVD standardized to 28 days as a covariate.||0.896|0.388|=0.014
71880582|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.0141|TWO_SIDED|95.0|-3.3|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 2||-0.37|-3.30|0.0141
71880583|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.22||||0.0152|TWO_SIDED|95.0|-4.0|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 4||-0.43|-4.00|0.0152
71880584|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.06||||0.001|TWO_SIDED|95.0|-4.86|-1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 4||-1.25|-4.86|0.0010
71880585|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.41||||0.0245|TWO_SIDED|95.0|-4.5|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 6||-0.31|-4.50|0.0245
71880586|NCT00880399|143280636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.86||||0.0082|TWO_SIDED|95.0|-4.97|-0.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 6||-0.75|-4.97|0.0082
71880587|NCT00880399|143280638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.6||||0.51|TWO_SIDED|95.0|0.8|3.19|||Log Rank|||Placebo Vs Orvepitant 30 mg at Week 6||3.19|0.80|0.51
71920494|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-23.119|STANDARD_ERROR_OF_MEAN|10.461||0.015|TWO_SIDED|95.0|-43.923|-2.315|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-2.315|-43.923|0.015
71920495|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.159|STANDARD_ERROR_OF_MEAN|10.535||0.054|TWO_SIDED|95.0|-38.108|3.789|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.789|-38.108|0.054
71920496|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.416|STANDARD_ERROR_OF_MEAN|12.718||0.029|TWO_SIDED|95.0|-49.696|0.865|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||0.865|-49.696|0.029
71687421|NCT02798354|142891712|SUPERIORITY||Risk Difference (RD)|3.9|||<|0.0001|TWO_SIDED|95.0|2.4|5.3|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||5.3|2.4|<0.0001
71687422|NCT02798354|142891713|SUPERIORITY||Risk Difference (RD)|16.0|||<|0.0001|TWO_SIDED|95.0|12.3|20.0|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||20|12.3|<0.0001
71880588|NCT00880399|143280638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.66||||0.37|TWO_SIDED|95.0|0.84|3.3|||Log Rank|||Placebo Vs Orvepitant 60 mg at Week 6||3.30|0.84|0.37
71880589|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.7859|TWO_SIDED|95.0|-0.72|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.55|-0.72|0.7859
71880590|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.15||||0.6429|TWO_SIDED|95.0|-0.79|0.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.49|-0.79|0.6429
71880591|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.04||||0.0092|TWO_SIDED|95.0|-1.82|-0.26|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.26|-1.82|0.0092
71880592|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.91||||0.023|TWO_SIDED|95.0|-1.69|-0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.13|-1.69|0.0230
71880593|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.0104|TWO_SIDED|95.0|-2.27|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.31|-2.27|0.0104
71880594|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.001|TWO_SIDED|95.0|-2.67|-0.69|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.69|-2.67|0.0010
71880595|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.0361|TWO_SIDED|95.0|-2.37|-0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.08|-2.37|0.0361
71880596|NCT00880399|143280639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.54||||0.0092||95.0|-2.69|-0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.38|-2.69|0.0092
71880597|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.72||||0.1662|TWO_SIDED|95.0|-1.74|0.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.30|-1.74|0.1662
71880598|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.2116|TWO_SIDED|95.0|-1.69|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.38|-1.69|0.2116
71920497|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-6.287|STANDARD_ERROR_OF_MEAN|12.705||0.311|TWO_SIDED|95.0|-31.541|18.968|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.968|-31.541|0.311
71920498|NCT02055976|143362593|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-32.443|STANDARD_ERROR_OF_MEAN|12.555||0.006|TWO_SIDED|95.0|-57.4|-7.485|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.485|-57.400|0.006
71920499|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-35.967|STANDARD_ERROR_OF_MEAN|10.822|<|0.001|TWO_SIDED|95.0|-57.463|-14.472|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-14.472|-57.463|<0.001
71880599|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.02||||0.082|TWO_SIDED|95.0|-2.17|0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.13|-2.17|0.0820
71687423|NCT02798354|142891714|SUPERIORITY||Risk Difference (RD)|1.1||||0.302|TWO_SIDED|95.0|-1.0|3.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||3.1|-1.0|0.302
71687424|NCT02798354|142891715|SUPERIORITY||Risk Difference (RD)|26.6|||<|0.0001|TWO_SIDED|95.0|22.4|30.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||30.7|22.4|<0.0001
71880600|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.3498|TWO_SIDED|95.0|-1.71|0.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.61|-1.71|0.3498
71880601|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.69||||0.0107|TWO_SIDED|95.0|-2.99|-0.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.40|-2.99|0.0107
71880602|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.1||||0.0017|TWO_SIDED|95.0|-3.4|-0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.79|-3.40|0.0017
71880603|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.29||||0.088|TWO_SIDED|95.0|-2.78|0.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.19|-2.78|0.0880
71880604|NCT00880399|143280640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.68||||0.0282|TWO_SIDED|95.0|-3.17|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.18|-3.17|0.0282
71880605|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9854|TWO_SIDED|95.0|-0.45|0.44|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.44|-0.45|0.9854
71880606|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.3476|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.23|-0.66|0.3476
71880607|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0898|TWO_SIDED|95.0|-0.94|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.07|-0.94|0.0898
71880608|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.0928|TWO_SIDED|95.0|-0.95|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.07|-0.95|0.0928
71880609|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.32||||0.2937|TWO_SIDED|95.0|-0.93|0.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.28|-0.93|0.2937
71880610|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.0587|TWO_SIDED|95.0|-1.2|0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.02|-1.20|0.0587
71880611|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.195|TWO_SIDED|95.0|-1.14|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.23|-1.14|0.1950
71880612|NCT00880399|143280641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.0498|TWO_SIDED|95.0|-1.4|0.0|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.00|-1.40|0.0498
71880613|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.14||||0.1731|TWO_SIDED|95.0|0.72|6.4|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 1||6.40|0.72|0.1731
71880614|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.77||||0.7084|TWO_SIDED|95.0|0.2|2.97|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 1||2.97|0.20|0.7084
71880615|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.6||||0.0247|TWO_SIDED|95.0|1.13|5.98|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 2||5.98|1.13|0.0247
71880616|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.8||||0.1862|TWO_SIDED|95.0|0.75|4.3|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 2||4.30|0.75|0.1862
71880617|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.87||||0.063|TWO_SIDED|95.0|0.97|3.61|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 4||3.61|0.97|0.0630
71880618|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.65||||0.1413|TWO_SIDED|95.0|0.85|3.23|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 4||3.23|0.85|0.1413
71880619|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.77||||0.0806|TWO_SIDED|95.0|0.93|3.37|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 6||3.37|0.93|0.0806
71880620|NCT00880399|143280642|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.53||||0.2007|TWO_SIDED|95.0|0.8|2.92|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 6||2.92|0.80|0.2007
71880621|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2523|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.07|-0.25|0.2523
71880622|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.2639|TWO_SIDED|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.07|-0.25|0.2639
71880623|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.0004|TWO_SIDED|95.0|-0.58|-0.17|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||-0.17|-0.58|0.0004
71880624|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.0348|TWO_SIDED|95.0|-0.43|-0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||-0.02|-0.43|0.0348
71880625|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.0166|TWO_SIDED|95.0|-0.62|-0.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||-0.06|-0.62|0.0166
71880626|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.0014|TWO_SIDED|95.0|-0.75|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||-0.18|-0.75|0.0014
71880627|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.0099|TWO_SIDED|95.0|-0.79|-0.11|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.11|-0.79|0.0099
71880628|NCT00880399|143280643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.0059|TWO_SIDED|95.0|-0.83|-0.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.14|-0.83|0.0059
71880629|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.5473|TWO_SIDED|95.0|-2.04|1.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.08|-2.04|0.5473
71920500|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-29.186|STANDARD_ERROR_OF_MEAN|11.044||0.005|TWO_SIDED|95.0|-51.123|-7.249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-7.249|-51.123|0.005
71880630|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.9814|TWO_SIDED|95.0|-1.56|1.6|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.60|-1.56|0.9814
71880631|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.51||||0.0515|TWO_SIDED|95.0|-3.03|0.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.01|-3.03|0.0515
71687425|NCT02798354|142891716|SUPERIORITY||Risk Difference (RD)|20.1|||<|0.0001|TWO_SIDED|95.0|16.2|24.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||24.1|16.2|<0.0001
71880632|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.468|TWO_SIDED|95.0|-2.09|0.96|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.96|-2.09|0.4680
71880633|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22||||0.1757|TWO_SIDED|95.0|-2.98|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.55|-2.98|0.1757
71880634|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15||||0.2048|TWO_SIDED|95.0|-2.93|0.63|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.63|-2.93|0.2048
71880635|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16||||0.0312|TWO_SIDED|95.0|-4.12|-0.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||-0.20|-4.12|0.0312
71880636|NCT00880399|143280644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.34||||0.0202|TWO_SIDED|95.0|-4.31|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.37|-4.31|0.0202
71880637|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.45||||0.7246|TWO_SIDED|95.0|-20.38|29.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 1||29.28|-20.38|0.7246
71880638|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|27.36||||0.0332|TWO_SIDED|95.0|2.2|52.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 1||52.52|2.20|0.0332
71880639|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.12||||0.5439|TWO_SIDED|95.0|-18.18|34.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 2||34.41|-18.18|0.5439
71880640|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.52||||0.3127|TWO_SIDED|95.0|-12.8|39.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 2||39.85|-12.80|0.3127
71880641|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-17.51||||0.2419|TWO_SIDED|95.0|-46.9|11.89|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 4||11.89|-46.90|0.2419
71880642|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Median Difference (Net)|21.11||||0.1606|TWO_SIDED|95.0|-8.43|50.64|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 4||50.64|-8.43|0.1606
71880643|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.48||||0.7412||95.0|-22.21|31.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 6||31.16|-22.21|0.7412
71880644|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.47||||0.3974|TWO_SIDED|95.0|-15.19|38.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 6||38.14|-15.19|0.3974
71880645|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.52||||0.1397|TWO_SIDED|95.0|-26.83|3.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 1||3.79|-26.83|0.1397
71880646|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.9||||0.0026|TWO_SIDED|95.0|-39.4|-8.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 1||-8.41|-39.40|0.0026
71880647|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.67||||0.3206|TWO_SIDED|95.0|-22.85|7.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 2||7.50|-22.85|0.3206
71880648|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.67||||0.0015|TWO_SIDED|95.0|-39.86|-9.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 2||-9.49|-39.86|0.0015
71880649|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.71||||0.2157|TWO_SIDED|95.0|-27.7|6.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 4||6.28|-27.70|0.2157
71880650|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.31||||0.0784|TWO_SIDED|95.0|-32.37|1.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 4||1.75|-32.37|0.0784
71880651|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.84||||0.3345|TWO_SIDED|95.0|-7.09|20.78|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 6||20.78|-7.09|0.3345
71880652|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.25||||0.6471|TWO_SIDED|95.0|-17.19|10.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 6||10.70|-17.19|0.6471
71880653|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4||||0.8071|TWO_SIDED|95.0|-16.95|21.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 1||21.75|-16.95|0.8071
71880654|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.3||||0.3564|TWO_SIDED|95.0|-29.11|10.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 1||10.52|-29.11|0.3564
71920501|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.01|STANDARD_ERROR_OF_MEAN|11.16|<|0.001|TWO_SIDED|95.0|-62.175|-17.845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-17.845|-62.175|<0.001
71687426|NCT02798354|142891717|SUPERIORITY||Risk Difference (RD)|14.0|||<|0.0001|TWO_SIDED|95.0|10.3|17.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave|||17.7|10.3|<0.0001
71880655|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-15.86||||0.122|TWO_SIDED|95.0|-36.0|4.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 2||4.28|-36.00|0.1220
71880656|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.25||||0.0313|TWO_SIDED|95.0|-42.49|-2.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 2||-2.01|-42.49|0.0313
71687427|NCT02798354|142891718|SUPERIORITY||Risk Difference (RD)|0.1||||0.922|TWO_SIDED|95.0|-1.8|1.9|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave|||1.9|-1.8|0.922
71880657|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.15||||0.8861|TWO_SIDED|95.0|-27.45|31.76|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 4||31.76|-27.45|0.8861
71880658|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.67||||0.9132|TWO_SIDED|95.0|-31.87|28.53|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 4||28.53|-31.87|0.9132
71880659|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.09||||0.7844|TWO_SIDED|95.0|-33.55|25.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||25.37|-33.55|0.7844
71880660|NCT00880399|143280645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.8497|TWO_SIDED|95.0|-27.33|33.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6||33.14|-27.33|0.8497
71880661|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.4814|TWO_SIDED|95.0|-0.83|0.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||0.39|-0.83|0.4814
71880662|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.6179|TWO_SIDED|95.0|-0.47|0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||0.79|-0.47|0.6179
71880663|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.5022|TWO_SIDED|95.0|-0.44|0.21|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||0.21|-0.44|0.5022
71880664|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.1389|TWO_SIDED|95.0|-0.57|0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||0.08|-0.57|0.1389
71880665|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.9663|TWO_SIDED|95.0|-0.36|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||0.38|-0.36|0.9663
71880666|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.1311|TWO_SIDED|95.0|-0.67|0.09|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||0.09|-0.67|0.1311
71880667|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.1362|TWO_SIDED|95.0|-0.73|0.1|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||0.10|-0.73|0.1362
71880668|NCT00880399|143280646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48||||0.0275|TWO_SIDED|95.0|-0.91|-0.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.05|-0.91|0.0275
71880669|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.0606|TWO_SIDED|95.0|-0.02|1.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 1||1.06|-0.02|0.0606
71880670|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69||||0.0132|TWO_SIDED|95.0|0.15|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 1||1.24|0.15|0.0132
71880671|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.001|TWO_SIDED|95.0|0.38|1.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 2||1.50|0.38|0.0010
71880672|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.0034|TWO_SIDED|95.0|0.28|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 2||1.40|0.28|0.0034
71880673|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13||||0.6692|TWO_SIDED|95.0|-0.47|0.72|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 4||0.72|-0.47|0.6692
71880674|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.82||||0.0078|TWO_SIDED|95.0|0.22|1.42|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 4||1.42|0.22|0.0078
71880675|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66||||0.044|TWO_SIDED|95.0|0.02|1.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 6||1.30|0.02|0.0440
71880676|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0181|TWO_SIDED|95.0|0.13|1.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 6||1.41|0.13|0.0181
71880677|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.1484|TWO_SIDED|95.0|-0.14|0.92|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 1||0.92|-0.14|0.1484
71880678|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.7||||0.0108|TWO_SIDED|95.0|0.16|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 1||1.24|0.16|0.0108
71880679|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.0361||95.0|0.04|1.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 2||1.16|0.04|0.0361
71880680|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.0418|TWO_SIDED|95.0|0.02|1.15|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 2||1.15|0.02|0.0418
71880681|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.9305|TWO_SIDED|95.0|-0.64|0.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 4||0.58|-0.64|0.9305
71880682|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.77||||0.0141|TWO_SIDED|95.0|0.16|1.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 4||1.39|0.16|0.0141
71687428|NCT00528372|142891722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1522||0.0207||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0207
71880683|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.65||||0.0562|TWO_SIDED|95.0|-0.02|1.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.31|-0.02|0.0562
71687429|NCT00528372|142891722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1541||0.0005||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0005
71880684|NCT00880399|143280647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.0296|TWO_SIDED|95.0|0.07|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6||1.40|0.07|0.0296
71880685|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.2||||0.0735|TWO_SIDED|95.0|-0.21|4.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||4.61|-0.21|0.0735
71880686|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.35||||0.2905|TWO_SIDED|95.0|-1.17|3.86|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||3.86|-1.17|0.2905
71880687|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.05||||0.4327|TWO_SIDED|95.0|-1.6|3.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||3.70|-1.60|0.4327
71880688|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.01||||0.4642|TWO_SIDED|95.0|-1.73|3.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||3.75|-1.73|0.4642
71920502|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|3.17|STANDARD_ERROR_OF_MEAN|10.906||0.614|TWO_SIDED|95.0|-18.502|24.842|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||24.842|-18.502|0.614
71880689|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.48||||0.285|TWO_SIDED|95.0|-1.26|4.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||4.23|-1.26|0.2850
71880690|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.5984|TWO_SIDED|95.0|-2.08|3.59|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||3.59|-2.08|0.5984
71880691|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.21||||0.4192|TWO_SIDED|95.0|-1.76|4.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||4.19|-1.76|0.4192
71687430|NCT00528372|142891722|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.1518|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
71687431|NCT00528372|142891722|SUPERIORITY_OR_OTHER||Difference from placebo|-0.61|STANDARD_ERROR_OF_MEAN|0.1536|||TWO_SIDED|95.0|-0.91|-0.3||||||||-0.30|-0.91|
71880692|NCT00880399|143280651|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.6766|TWO_SIDED|95.0|-2.42|3.71|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||3.71|-2.42|0.6766
71880693|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9951|TWO_SIDED|95.0|-1.26|1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1||1.25|-1.26|0.9951
71880694|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.894|TWO_SIDED|95.0|-1.17|1.34|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1||1.34|-1.17|0.8940
71880695|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.8195|TWO_SIDED|95.0|-1.61|1.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2||1.28|-1.61|0.8195
71880696|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.4106|TWO_SIDED|95.0|-0.84|2.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2||2.05|-0.84|0.4106
71880697|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.9403|TWO_SIDED|95.0|-1.71|1.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4||1.85|-1.71|0.9403
71880698|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.5206|TWO_SIDED|95.0|-2.36|1.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4||1.20|-2.36|0.5206
71880699|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.714|TWO_SIDED|95.0|-2.3|1.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6||1.58|-2.30|0.7140
71880700|NCT00880399|143280652|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.26||||0.0234|TWO_SIDED|95.0|-4.22|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6||-0.31|-4.22|0.0234
71920503|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-8.563|STANDARD_ERROR_OF_MEAN|11.067||0.221|TWO_SIDED|95.0|-30.554|13.427|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||13.427|-30.554|0.221
71880701|NCT01911442|143280653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|2.15||0.5463|TWO_SIDED|95.0|-5.6|3.0|||Mixed Models Analysis|||LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||3.0|-5.6|0.5463
71880702|NCT01911442|143280653|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|2.09||0.3592|TWO_SIDED|95.0|-6.1|2.2|||Mixed Models Analysis|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.||2.2|-6.1|0.3592
71880703|NCT01911442|143280654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.25||0.1755|TWO_SIDED||||||Mixed Models Analysis||This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.|||||0.1755
71880704|NCT01911442|143280654|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.24||0.2402|TWO_SIDED||||||Mixed Models Analysis|||||||0.2402
71880705|NCT00122681|143280662|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.9|||||TWO_SIDED|95.0|79.9|98.3||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.3|79.9|
71880706|NCT00122681|143280662|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|82.9|99.6||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||99.6|82.9|
71880707|NCT00122681|143280662|SUPERIORITY_OR_OTHER||1-Rate Ratio|86.7|||||TWO_SIDED|95.0|39.7|98.7||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||98.7|39.7|
71880708|NCT00122681|143280662|SUPERIORITY_OR_OTHER||1-Rate Ratio|90.8|||||TWO_SIDED|95.0|78.1|96.9||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||96.9|78.1|
71880709|NCT00122681|143280662|SUPERIORITY_OR_OTHER||1-Rate Ratio|92.7|||||TWO_SIDED|95.0|79.3|98.2||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.2|79.3|
71880710|NCT00122681|143280662|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|44.1|98.8||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.8|44.1|
71880711|NCT00122681|143280663|SUPERIORITY_OR_OTHER||1-Rate Ratio|94.9|||||TWO_SIDED|95.0|87.7|98.4||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||98.4|87.7|
71880712|NCT00122681|143280663|SUPERIORITY_OR_OTHER||1-Rate Ratio|97.6|||||TWO_SIDED|95.0|91.0|99.7||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed||99.7|91.0|
71687432|NCT00528372|142891722|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1527|||TWO_SIDED|95.0|-0.86|-0.26||||||||-0.26|-0.86|
71687433|NCT00528372|142891722|SUPERIORITY_OR_OTHER||Difference from placebo|-0.56|STANDARD_ERROR_OF_MEAN|0.1474|||TWO_SIDED|95.0|-0.85|-0.27||||||||-0.27|-0.85|
71920504|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.649|STANDARD_ERROR_OF_MEAN|10.933||0.303|TWO_SIDED|95.0|-27.376|16.079|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.079|-27.376|0.303
71920505|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-22.003|STANDARD_ERROR_OF_MEAN|14.53||0.067|TWO_SIDED|95.0|-50.882|6.875|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||6.875|-50.882|0.067
71920506|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.761|STANDARD_ERROR_OF_MEAN|14.676||0.003|TWO_SIDED|95.0|-70.934|-12.588|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-12.588|-70.934|0.003
71920507|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-34.933|STANDARD_ERROR_OF_MEAN|14.832||0.01|TWO_SIDED|95.0|-64.41|-5.456|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.456|-64.410|0.010
71687434|NCT00528372|142891723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|STANDARD_ERROR_OF_MEAN|5.734||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|||Week 24|||||
71687435|NCT00528372|142891723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|5.806||0.0007||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||0.0007
71687436|NCT00528372|142891723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.7|STANDARD_ERROR_OF_MEAN|5.626|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05)|ANCOVA||Week 24|||||<0.0001
71687437|NCT00528372|142891723|SUPERIORITY_OR_OTHER||Difference from placebo|-21.5|STANDARD_ERROR_OF_MEAN|5.686|||TWO_SIDED|95.0|-32.6|-10.3||||||||-10.3|-32.6|
71687438|NCT00528372|142891723|SUPERIORITY_OR_OTHER||Difference from placebo|-23.3|STANDARD_ERROR_OF_MEAN|5.711|||TWO_SIDED|95.0|-34.4|-12.0||||||||-12.0|-34.4|
71920508|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.978|STANDARD_ERROR_OF_MEAN|11.725||0.064|TWO_SIDED|95.0|-41.282|5.326|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||5.326|-41.282|0.064
71920509|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-5.654|STANDARD_ERROR_OF_MEAN|11.903||0.318|TWO_SIDED|95.0|-29.311|18.004|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||18.004|-29.311|0.318
71920510|NCT02055976|143362595|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-19.435|STANDARD_ERROR_OF_MEAN|11.807||0.052|TWO_SIDED|95.0|-42.902|4.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.032|-42.902|0.052
71920511|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.974|STANDARD_ERROR_OF_MEAN|7.674|<|0.001|TWO_SIDED|95.0|-41.217|-10.731|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-10.731|-41.217|<0.001
71687439|NCT00528372|142891723|SUPERIORITY_OR_OTHER||Difference from placebo|-25.5|STANDARD_ERROR_OF_MEAN|5.567|||TWO_SIDED|95.0|-36.4|-14.5||||||||-14.5|-36.4|
71687440|NCT00528372|142891725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|0.6307||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.||||||||
71687441|NCT00528372|142891725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65|STANDARD_ERROR_OF_MEAN|0.6388||0.3101||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.3101
71687442|NCT00528372|142891725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.6223||0.1189||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||||||0.1189
71687443|NCT00528372|142891725|SUPERIORITY_OR_OTHER||Difference from placebo|-1.63|STANDARD_ERROR_OF_MEAN|0.6254|||TWO_SIDED|95.0|-2.86|-0.41||||||||-0.41|-2.86|
71687444|NCT00528372|142891725|SUPERIORITY_OR_OTHER||Difference from placebo|-1.36|STANDARD_ERROR_OF_MEAN|0.6279|||TWO_SIDED|95.0|-2.6|-0.13||||||||-0.13|-2.60|
71687445|NCT00528372|142891725|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
71687446|NCT00528372|142891727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|4.324||||||||||||||||
71687447|NCT00528372|142891727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.9|STANDARD_ERROR_OF_MEAN|4.342||||||||||||||||
71687448|NCT00528372|142891727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.6|STANDARD_ERROR_OF_MEAN|4.176||||||||||||||||
71687449|NCT00528372|142891727|SUPERIORITY_OR_OTHER||Difference from placebo|-12.0|STANDARD_ERROR_OF_MEAN|4.223|||TWO_SIDED|95.0|-20.3|-3.7||||||||-3.7|-20.3|
71687450|NCT00528372|142891727|SUPERIORITY_OR_OTHER||Difference from placebo|-16.2|STANDARD_ERROR_OF_MEAN|4.321|||TWO_SIDED|95.0|-24.7|-7.7||||||||-7.7|-24.7|
71687451|NCT00528372|142891727|SUPERIORITY_OR_OTHER||Difference from placebo|-17.9|STANDARD_ERROR_OF_MEAN|4.228|||TWO_SIDED|95.0|-26.2|-9.5||||||||-9.5|-26.2|
71687452|NCT00528372|142891729|SUPERIORITY_OR_OTHER||Percentage difference|9.7||||||||||||||||||
71687453|NCT00528372|142891729|SUPERIORITY_OR_OTHER||Percentage difference|12.6||||||||||||||||||
71687454|NCT00528372|142891729|SUPERIORITY_OR_OTHER||Percentage difference|19.2||||||||||||||||||
71687455|NCT00528372|142891729|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.8|||||TWO_SIDED|95.0|4.9|34.7||||||||34.7|4.9|
71687456|NCT00528372|142891729|SUPERIORITY_OR_OTHER||Percent difference from placebo|12.4|||||TWO_SIDED|95.0|-2.5|27.3||||||||27.3|-2.5|
71687457|NCT00528372|142891729|SUPERIORITY_OR_OTHER||Percent difference from placebo|19.9|||||TWO_SIDED|95.0|5.3|34.5||||||||34.5|5.3|
71687458|NCT00528372|142891730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.6979||||||||||||||||
71687459|NCT00528372|142891730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.6828||||||||||||||||
71687460|NCT00528372|142891730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|0.6404||||||||||||||||
71687461|NCT00528372|142891730|SUPERIORITY_OR_OTHER||Difference from placebo|-1.55|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
71687462|NCT00528372|142891730|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
71687463|NCT00528372|142891730|SUPERIORITY_OR_OTHER||Difference from placebo|-0.87|STANDARD_ERROR_OF_MEAN|0.6103|||TWO_SIDED|95.0|-2.06|0.33||||||||0.33|-2.06|
71687464|NCT00528372|142891731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
71687465|NCT00528372|142891731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.175||||||||||||||||
71687466|NCT00528372|142891731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.1708||||||||||||||||
71687467|NCT00528372|142891731|SUPERIORITY_OR_OTHER||Difference from placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.1798|||TWO_SIDED|95.0|-0.95|-0.25||||||||-0.25|-0.95|
71687468|NCT00528372|142891731|SUPERIORITY_OR_OTHER||Difference from placebo|-0.55|STANDARD_ERROR_OF_MEAN|0.1741|||TWO_SIDED|95.0|-0.89|-0.21||||||||-0.21|-0.89|
71687469|NCT00528372|142891731|SUPERIORITY_OR_OTHER||Difference from placebo|-0.58|STANDARD_ERROR_OF_MEAN|0.1704|||TWO_SIDED|95.0|-0.92|-0.25||||||||-0.25|-0.92|
71687470|NCT00528372|142891732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_ERROR_OF_MEAN|6.526||||||||||||||||
71687471|NCT00528372|142891732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|6.761||||||||||||||||
71687472|NCT00528372|142891732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_ERROR_OF_MEAN|6.334||||||||||||||||
71687473|NCT00528372|142891732|SUPERIORITY_OR_OTHER||Percent difference from placebo|18.8|||||TWO_SIDED|95.0|5.5|32.1||||||||32.1|5.5|
71687474|NCT00528372|142891732|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.3|||||TWO_SIDED|95.0|-1.8|24.4||||||||24.4|-1.8|
71687475|NCT00528372|142891732|SUPERIORITY_OR_OTHER||Percent difference from placebo|11.4|||||TWO_SIDED|95.0|-1.0|23.9||||||||23.9|-1.0|
71687476|NCT00528372|142891733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.736||||||||||||||||
71687477|NCT00528372|142891733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.7371||||||||||||||||
71687478|NCT00528372|142891733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96|STANDARD_ERROR_OF_MEAN|0.7078||||||||||||||||
71687479|NCT00528372|142891733|SUPERIORITY_OR_OTHER||Difference from placebo|-1.87|STANDARD_ERROR_OF_MEAN|0.7394|||TWO_SIDED|95.0|-3.33|-0.42||||||||-0.42|-3.33|
71687480|NCT00528372|142891733|SUPERIORITY_OR_OTHER||Difference from placebo|-1.27|STANDARD_ERROR_OF_MEAN|0.7257|||TWO_SIDED|95.0|-2.69|0.16||||||||0.16|-2.69|
71687481|NCT00528372|142891733|SUPERIORITY_OR_OTHER||Difference from placebo|-0.97|STANDARD_ERROR_OF_MEAN|0.7135||||95.0|-2.37|0.44||||||||0.44|-2.37|
71687482|NCT02774005|142891748|SUPERIORITY||Odds Ratio (OR)|2.286||||0.0021|TWO_SIDED|95.0|1.352|3.884|||Wald Chi-square|||||3.884|1.352|0.0021
71880713|NCT00122681|143280663|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.1|||||TWO_SIDED|95.0|57.2|97.5||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.||97.5|57.2|
71880714|NCT00122681|143280663|SUPERIORITY_OR_OTHER||1-Rate Ratio|93.6|||||TWO_SIDED|95.0|86.3|97.5||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.5|86.3|
71687483|NCT02774005|142891749|SUPERIORITY||Odds Ratio (OR)|1.646||||0.0873|TWO_SIDED|95.0|0.929|2.918|||Waldi-Chi-Square|||||2.918|0.929|0.0873
71687484|NCT02774005|142891750|SUPERIORITY||Odds Ratio (OR)|7.323||||0.0005|TWO_SIDED|95.0|2.339|25.912|||Waldi-Chi-Square|||||25.912|2.339|0.0005
71687485|NCT02379273|142891755|SUPERIORITY||||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||A Friedman repeated-measures ANOVA on ranks was applied to the unilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.||||<0.001
71687486|NCT02379273|142891755|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral CNC data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
71687487|NCT02379273|142891756|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the unilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
71687488|NCT02379273|142891756|SUPERIORITY|A Friedman repeated-measures ANOVA on ranks was applied to the bilateral AzBio data with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p = 0.05.|ANOVA|||||||<0.001
71880715|NCT00122681|143280663|SUPERIORITY_OR_OTHER||1-Rate Ratio|95.7|||||TWO_SIDED|95.0|88.5|98.9||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||98.9|88.5|
71880716|NCT00122681|143280663|SUPERIORITY_OR_OTHER||1-Rate Ratio|87.6|||||TWO_SIDED|95.0|59.2|97.6||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).||97.6|59.2|
71880717|NCT00122681|143280688|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.798||||0.391|TWO_SIDED|95.0|0.476|1.337|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection||1.337|0.476|0.3910
71880718|NCT00122681|143280690|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.778||||0.3796|TWO_SIDED|95.0|0.444|1.362|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.362|0.444|0.3796
71880719|NCT00122681|143280692|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.1035||95.0|0.337|1.106|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.||1.106|0.337|0.1035
71880720|NCT00122681|143280694|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.635||||0.2111|TWO_SIDED|95.0|0.312|1.293|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.||1.293|0.312|0.2111
71880721|NCT02819635|143280697|SUPERIORITY||Adjusted risk difference (%)|8.4||||0.049|TWO_SIDED|95.0|0.0|16.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||16.8|0.0|0.049
71880722|NCT02819635|143280697|SUPERIORITY||Adjusted risk difference (%)|13.5||||0.01|TWO_SIDED|95.0|3.3|23.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||23.8|3.3|0.010
71880723|NCT02819635|143280697|SUPERIORITY||Adjusted risk difference (%)|13.8||||0.007|TWO_SIDED|95.0|3.8|23.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||23.9|3.8|0.007
71880724|NCT02819635|143280697|SUPERIORITY||Adjusted risk difference (%)|21.1|||<|0.001|TWO_SIDED|95.0|8.6|33.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||33.6|8.6|<0.001
71880725|NCT02819635|143280698|SUPERIORITY||Adjusted risk difference (%)|21.6|||<|0.001|TWO_SIDED|95.0|15.8|27.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||27.4|15.8|<0.001
71880726|NCT02819635|143280699|SUPERIORITY||Adjusted risk difference (%)|30.7|||<|0.001|TWO_SIDED|95.0|21.7|39.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||39.8|21.7|<0.001
71880727|NCT02819635|143280699|SUPERIORITY||Adjusted risk difference (%)|39.0|||<|0.001|TWO_SIDED|95.0|29.7|48.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||48.2|29.7|<0.001
71880728|NCT02819635|143280700|SUPERIORITY||Adjusted risk difference (%)|13.1||||0.03|TWO_SIDED|95.0|1.2|25.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||25.0|1.2|0.030
71687489|NCT02379273|142891757|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
71687490|NCT02379273|142891758|SUPERIORITY|A one-way repeated-measures analysis of variance was applied to the data, with follow-up pairwise comparisons based on the Holm-Sidak method.|||||<|0.001|||||||ANOVA|The threshold for statistical significance was p=0.05.||||||<0.001
71687491|NCT02379273|142891759|SUPERIORITY|Pre- and postoperative mean scores were compared based on Friedman repeated-measures analysis of variance with follow-up pairwise comparisons based on the Tukey Test.|||||<|0.001||||||The threshold for statistical significance was p=0.05.|ANOVA|||||||<0.001
71687492|NCT03275389|142891806|EQUIVALENCE|The use of the adjuvant (AS03) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|2.47|||||TWO_SIDED|94.46|2.06|2.95|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS03 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 1, at Day 29 of D-SUIV Adjuvant Group 2 and Day 85 of D-SUIV Adjuvant Group 3) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.95|2.06|
71687493|NCT03275389|142891806|EQUIVALENCE|The use of the adjuvant (AS01) is to be considered justified if the lower limit of the 94.46% CI of the GMC ratio (adjuvanted vs non-adjuvanted) is \> 1.50|GMC ratio|1.75|||||TWO_SIDED|94.46|1.46|2.1|||Dunnett's t test|Comparison performed using a 2-sided alpha=0.1 and Dunnett adjustment for multiple comparisons,||To evaluate the adjuvant effect of AS01 (Pooling of results at Day 29 of D-SUIV Adjuvant Group 4, at Day 29 of D-SUIV Adjuvant Group 5 and Day 85 of D-SUIV Adjuvant Group 6) on the humoral immune response for anti-H1 stalk antibody by ELISA at Day 29 and Day 85 (i.e. 28 days post-vaccination) when compared to the non-adjuvanted formulations (Pooling of results at Day 29 of D-SUIV Unadjuvanted Group 1, at Day 29 of D-SUIV Unadjuvanted Group 2 and Day 85 of D-SUIV Unadjuvanted Group 3).||2.1|1.46|
71880729|NCT02819635|143280700|SUPERIORITY||Adjusted risk difference (%)|27.6|||<|0.001|TWO_SIDED|95.0|13.1|42.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||42.1|13.1|<0.001
71880730|NCT02819635|143280700|SUPERIORITY||Adjusted risk difference (%)|26.6|||<|0.001|TWO_SIDED|95.0|12.3|40.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||40.8|12.3|<0.001
71880731|NCT02819635|143280700|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|19.2|51.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||51.7|19.2|<0.001
71880732|NCT02819635|143280701|SUPERIORITY||Adjusted risk difference (%)|11.0||||0.021|TWO_SIDED|95.0|1.7|20.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||20.4|1.7|0.021
71880733|NCT02819635|143280701|SUPERIORITY||Adjusted risk difference (%)|9.6||||0.024|TWO_SIDED|95.0|1.3|18.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||18.0|1.3|0.024
71880734|NCT02819635|143280701|SUPERIORITY||Adjusted risk difference (%)|12.2||||0.015|TWO_SIDED|95.0|2.3|22.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||22.0|2.3|0.015
71880735|NCT02819635|143280701|SUPERIORITY||Adjusted risk difference (%)|20.1||||0.001|TWO_SIDED|95.0|8.0|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||32.1|8.0|0.001
71880736|NCT02819635|143280702|SUPERIORITY||Adjusted risk difference (%)|16.7||||0.038|TWO_SIDED|95.0|0.9|32.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||32.5|0.9|0.038
71880737|NCT02819635|143280702|SUPERIORITY||Adjusted risk difference (%)|35.2|||<|0.001|TWO_SIDED|95.0|17.5|52.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||52.8|17.5|<0.001
71880738|NCT02819635|143280702|SUPERIORITY||Adjusted risk difference (%)|33.6|||<|0.001|TWO_SIDED|95.0|16.3|50.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||50.8|16.3|<0.001
71880739|NCT02819635|143280702|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|26.2|63.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||63.9|26.2|<0.001
71880740|NCT02819635|143280703|SUPERIORITY||Adjusted risk difference (%)|5.9||||0.495|TWO_SIDED|95.0|-11.1|22.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||22.9|-11.1|0.495
71880741|NCT02819635|143280703|SUPERIORITY||Adjusted risk difference (%)|15.9||||0.074|TWO_SIDED|95.0|-1.6|33.4||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||33.4|-1.6|0.074
71880742|NCT02819635|143280703|SUPERIORITY||Adjusted risk difference (%)|19.2||||0.033|TWO_SIDED|95.0|1.6|36.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||36.9|1.6|0.033
71880743|NCT02819635|143280703|SUPERIORITY||Adjusted risk difference (%)|40.1|||<|0.001|TWO_SIDED|95.0|20.5|59.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||59.7|20.5|<0.001
71880744|NCT02819635|143280704|SUPERIORITY||LS Mean Difference|-2.142|||<|0.001|TWO_SIDED|95.0|-3.2323|-1.052||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||-1.0520|-3.2323|<0.001
71880745|NCT02819635|143280704|SUPERIORITY||LS Mean Difference|-2.938|||<|0.001|TWO_SIDED|95.0|-4.0284|-1.8478||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||-1.8478|-4.0284|<0.001
71880746|NCT02819635|143280704|SUPERIORITY||LS Mean Difference|-3.736|||<|0.001|TWO_SIDED|95.0|-4.8247|-2.647||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||-2.6470|-4.8247|<0.001
71880747|NCT02819635|143280704|SUPERIORITY||LS Mean Difference|-4.061|||<|0.001|TWO_SIDED|95.0|-5.1252|-2.9974||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|ANCOVA|Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\<= 7 and \> 7)), and Baseline value as covariate.|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||-2.9974|-5.1252|<0.001
71880748|NCT02819635|143280705|SUPERIORITY||Adjusted risk difference (%)|6.6||||0.075|TWO_SIDED|95.0|-0.7|13.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||13.9|-0.7|0.075
71880749|NCT02819635|143280705|SUPERIORITY||Adjusted risk difference (%)|3.8||||0.199|TWO_SIDED|95.0|-2.0|9.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||9.6|-2.0|0.199
71880750|NCT02819635|143280705|SUPERIORITY||Adjusted risk difference (%)|11.1||||0.015|TWO_SIDED|95.0|2.2|20.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||20.0|2.2|0.015
71880751|NCT02819635|143280705|SUPERIORITY||Adjusted risk difference (%)|17.8||||0.004|TWO_SIDED|95.0|5.8|29.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||29.9|5.8|0.004
71880752|NCT02819635|143280706|SUPERIORITY||Adjusted risk difference (%)|25.6||||0.003|TWO_SIDED|95.0|8.9|42.3||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 7.5 mg - Placebo|Substudy 1: Upadacitinib 7.5 mg vs Placebo||42.3|8.9|0.003
71880753|NCT02819635|143280706|SUPERIORITY||Adjusted risk difference (%)|43.6|||<|0.001|TWO_SIDED|95.0|25.4|61.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 15 mg - Placebo|Substudy 1: Upadacitinib 15 mg vs Placebo||61.8|25.4|<0.001
71880754|NCT02819635|143280706|SUPERIORITY||Adjusted risk difference (%)|39.4|||<|0.001|TWO_SIDED|95.0|21.3|57.5||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 30 mg - Placebo|Substudy 1: Upadacitinib 30 mg vs Placebo||57.5|21.3|<0.001
71687494|NCT02432144|142891823|SUPERIORITY||LS Mean|-62.28|STANDARD_ERROR_OF_MEAN|4.946|<|0.0001|TWO_SIDED|95.0|-71.98|-52.59||P-values are from generalized estimating equation (GEE) model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 0||-52.59|-71.98|< 0.0001
71687495|NCT02432144|142891823|SUPERIORITY||LS Mean|-67.18|STANDARD_ERROR_OF_MEAN|3.224|<|0.0001|TWO_SIDED|95.0|-73.49|-60.86||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 12||-60.86|-73.49|< 0.0001
71687496|NCT02432144|142891823|SUPERIORITY||LS Mean|-64.12|STANDARD_ERROR_OF_MEAN|4.016|<|0.0001|TWO_SIDED|95.0|-71.99|-56.24||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 24||-56.24|-71.99|< 0.0001
71880755|NCT02819635|143280706|SUPERIORITY||Adjusted risk difference (%)|43.1|||<|0.001|TWO_SIDED|95.0|24.4|61.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 1: Upadacitinib 45 mg vs Placebo||61.9|24.4|<0.001
71880756|NCT02819635|143280707|SUPERIORITY||Adjusted risk difference (%)|29.3|||<|0.001|TWO_SIDED|95.0|22.6|35.9||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.9|22.6|<0.001
71880757|NCT02819635|143280708|SUPERIORITY||Adjusted risk difference (%)|12.7|||<|0.001|TWO_SIDED|95.0|8.4|17.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||17.0|8.4|<0.001
71880758|NCT02819635|143280709|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|38.4|54.2||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||54.2|38.4|<0.001
71880759|NCT02819635|143280710|SUPERIORITY||Adjusted risk difference (%)|33.3|||<|0.001|TWO_SIDED|95.0|24.8|41.8||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)||Substudy 2: Upadacitinib 45 mg vs Placebo|Difference = Upadacitinib 45 mg - Placebo|41.8|24.8|<0.001
71880760|NCT02819635|143280711|SUPERIORITY||Adjusted risk difference (%)|23.7|||<|0.001|TWO_SIDED|95.0|17.5|30.0||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||30.0|17.5|<0.001
71880761|NCT02819635|143280712|SUPERIORITY||Adjusted risk difference (%)|27.4|||<|0.001|TWO_SIDED|95.0|19.2|35.6||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||35.6|19.2|<0.001
71880762|NCT02819635|143280713|SUPERIORITY||Adjusted risk difference (%)|23.6|||<|0.001|TWO_SIDED|95.0|15.1|32.1||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||32.1|15.1|<0.001
71687497|NCT02432144|142891823|SUPERIORITY||LS Mean|-60.8|STANDARD_ERROR_OF_MEAN|5.992|<|0.0001|TWO_SIDED|95.0|-72.54|-49.06||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 36||-49.06|-72.54|< 0.0001
71880763|NCT02819635|143280714|SUPERIORITY||Adjusted risk difference (%)|32.2|||<|0.001|TWO_SIDED|95.0|23.8|40.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \> 7)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.7|23.8|<0.001
71880764|NCT02819635|143280715|SUPERIORITY||Least Squares (LS) Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|3.39|<|0.001|TWO_SIDED|95.0|27.02|40.36||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||40.36|27.02|<0.001
71687498|NCT02432144|142891823|SUPERIORITY||LS Mean|-57.85|||<|0.0001|TWO_SIDED|95.0|-71.87|-43.82||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 48||-43.82|-71.87|< 0.0001
71687499|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.462||0.6797||95.0|-0.83|1.22|||ANOVA|||Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose.||1.22|-0.83|0.6797
71687500|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.528||0.4811||95.0|-1.54|0.77|||ANOVA|||Difference from placebo (including Baseline), Day 1: 1 hour post-dose.||0.77|-1.54|0.4811
71687501|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.454||0.1693||95.0|-1.67|0.33|||ANOVA|||Difference from placebo (including Baseline), Day 1: 2 hours post-dose.||0.33|-1.67|0.1693
71687502|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.487||0.4034||95.0|-1.78|0.87|||ANOVA|||Difference from placebo (including Baseline) , Day 1: 3 hours post-dose.||0.87|-1.78|0.4034
71687503|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.694||0.1935||95.0|-2.36|0.5|||ANOVA|||Difference from placebo (including Baseline), Day 1: 4 hours post-dose.||0.50|-2.36|0.1935
71687504|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.715||0.0694||95.0|-2.83|0.12|||ANOVA|||Difference from placebo (including Baseline), Day 1: 5 hours post-dose.||0.12|-2.83|0.0694
71687505|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.713||0.0396||95.0|-3.02|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 1: 6 hours post-dose.||-0.08|-3.02|0.0396
71880765|NCT02819635|143280716|SUPERIORITY||Adjusted risk difference (%)|9.7|||<|0.001|TWO_SIDED|95.0|5.7|13.7||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \> 7), and bio-IR status (bio-IR or non-bio-IR)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||13.7|5.7|<0.001
71880766|NCT02819635|143280717|SUPERIORITY||Least Squares (LS) Mean Difference|6.7|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|4.79|8.59||The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).|Mixed-effect model repeated measurement|MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)|Difference = Upadacitinib 45 mg - Placebo|Substudy 2: Upadacitinib 45 mg vs Placebo||8.59|4.79|<0.001
71687506|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.319||0.1531||95.0|-1.25|0.24|||ANOVA|||Difference from placebo (including Baseline), Day 1: 8 hours post-dose.||0.24|-1.25|0.1531
71687507|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25|STANDARD_ERROR_OF_MEAN|0.637||0.0951||95.0|-2.79|0.29|||ANOVA|||Difference from placebo (including Baseline), Day 1: 10 hours post-dose.||0.29|-2.79|0.0951
71687508|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.615||0.0614||95.0|-2.84|0.09|||ANOVA|||Difference from placebo (including Baseline), Day 1: 12 hours post-dose.||0.09|-2.84|0.0614
71687509|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.87|STANDARD_ERROR_OF_MEAN|0.619||0.1946||95.0|-2.29|0.54|||ANOVA|||Difference from placebo (including Baseline), Day 8: pre-dose.||0.54|-2.29|0.1946
71687510|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.553||0.2843||95.0|-2.2|0.84|||ANOVA|||Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose.||0.84|-2.20|0.2843
71882923|NCT03787472|143284918|NON_INFERIORITY|The non-inferiority of the Test lens relative to the Control will be concluded if the upper confidence limit of LSM difference is below the non-inferiority margin 0.05 logMAR.|Least-Square Mean Difference|0.003|STANDARD_ERROR_OF_MEAN|0.0169|||TWO_SIDED|95.0|-0.03|0.037|||Linear Mixed Model||Mean difference was calculated as Test - Control|Near Standard High Contrast Bright||0.037|-0.030|
71687511|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.82||0.215||95.0|-2.75|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 1 hour post-dose.||0.65|-2.75|0.2150
71687512|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.189||0.9601||95.0|-0.44|0.42|||ANOVA|||Difference from placebo (including Baseline), Day 8: 2 hours post-dose.||0.42|-0.44|0.9601
71687513|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.311||0.867||95.0|-0.64|0.74|||ANOVA|||Difference from placebo (including baseline), Day 8: 3 hours post-dose.||0.74|-0.64|0.8670
71687514|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.393||0.9024||95.0|-0.94|0.84|||ANOVA|||Difference from placebo (including baseline), Day 8: 4 hours post-dose.||0.84|-0.94|0.9024
71687515|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.293||0.9708||95.0|-0.67|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 5 hours post-dose.||0.65|-0.67|0.9708
71687516|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.395||0.1078||95.0|-1.62|0.19|||ANOVA|||Difference from placebo (including Baseline), Day 8: 6 hours post-dose.||0.19|-1.62|0.1078
71687517|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.419||0.446||95.0|-1.28|0.61|||ANOVA|||Difference from placebo (including Baseline), Day 8: 8 hours post-dose.||0.61|-1.28|0.4460
71687518|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.394||0.5266||95.0|-1.13|0.62|||ANOVA|||Difference from placebo (including Baseline), Day 8: 10 hours post-dose.||0.62|-1.13|0.5266
71687519|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.273||0.029||95.0|-1.29|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 8: 12 hours post-dose.||-0.08|-1.29|0.0290
71687520|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.531||0.183||95.0|-2.01|0.45|||ANOVA|||Difference from placebo (including Baseline), Day 8: 24 hours post-dose.||0.45|-2.01|0.1830
71920512|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-21.11|STANDARD_ERROR_OF_MEAN|7.831||0.004|TWO_SIDED|95.0|-36.665|-5.555|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-5.555|-36.665|0.004
71920513|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-31.034|STANDARD_ERROR_OF_MEAN|7.917|<|0.001|TWO_SIDED|95.0|-46.758|-15.31|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-15.310|-46.758|<0.001
71920514|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|8.034|STANDARD_ERROR_OF_MEAN|9.553||0.799|TWO_SIDED|95.0|-10.948|27.015|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||27.015|-10.948|0.799
71920515|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.511|STANDARD_ERROR_OF_MEAN|9.682||0.398|TWO_SIDED|95.0|-21.748|16.727|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||16.727|-21.748|0.398
71920516|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.369|STANDARD_ERROR_OF_MEAN|9.58||0.515|TWO_SIDED|95.0|-18.668|19.407|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||19.407|-18.668|0.515
71920517|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-10.056|STANDARD_ERROR_OF_MEAN|8.801||0.128|TWO_SIDED|95.0|-27.549|7.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||7.437|-27.549|0.128
71920518|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-24.352|STANDARD_ERROR_OF_MEAN|8.882||0.004|TWO_SIDED|95.0|-42.008|-6.695|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-6.695|-42.008|0.004
71920519|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-14.994|STANDARD_ERROR_OF_MEAN|8.987||0.049|TWO_SIDED|95.0|-32.858|2.87|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||2.870|-32.858|0.049
71920520|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-13.83|STANDARD_ERROR_OF_MEAN|9.326||0.071|TWO_SIDED|95.0|-32.368|4.709|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||4.709|-32.368|0.071
71920521|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-3.378|STANDARD_ERROR_OF_MEAN|9.464||0.361|TWO_SIDED|95.0|-22.191|15.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||15.435|-22.191|0.361
71920522|NCT02055976|143362596|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-15.035|STANDARD_ERROR_OF_MEAN|9.389||0.056|TWO_SIDED|95.0|-33.698|3.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||3.629|-33.698|0.056
71920523|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.189|STANDARD_ERROR_OF_MEAN|5.431|<|0.001|TWO_SIDED|95.0|-86.975|-65.403|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-65.403|-86.975|<0.001
71920524|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-95.205|STANDARD_ERROR_OF_MEAN|5.556|<|0.001|TWO_SIDED|95.0|-106.238|-84.172|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-84.172|-106.238|<0.001
71920525|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-106.077|STANDARD_ERROR_OF_MEAN|5.622|<|0.001|TWO_SIDED|95.0|-117.239|-94.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-94.915|-117.239|<0.001
71920526|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.234|STANDARD_ERROR_OF_MEAN|6.622|<|0.001|TWO_SIDED|95.0|-84.39|-58.077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-58.077|-84.390|<0.001
71920527|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.638|STANDARD_ERROR_OF_MEAN|6.609|<|0.001|TWO_SIDED|95.0|-113.768|-87.508|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-87.508|-113.768|<0.001
71920528|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-103.386|STANDARD_ERROR_OF_MEAN|6.525|<|0.001|TWO_SIDED|95.0|-116.353|-90.42|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-90.420|-116.353|<0.001
71920529|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.124|STANDARD_ERROR_OF_MEAN|5.382|<|0.001|TWO_SIDED|95.0|-71.813|-50.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.435|-71.813|<0.001
71920530|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-81.837|STANDARD_ERROR_OF_MEAN|5.48|<|0.001|TWO_SIDED|95.0|-92.721|-70.954|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-70.954|-92.721|<0.001
71920531|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-89.683|STANDARD_ERROR_OF_MEAN|5.567|<|0.001|TWO_SIDED|95.0|-100.74|-78.627|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-78.627|-100.740|<0.001
71920532|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-76.747|STANDARD_ERROR_OF_MEAN|6.118|<|0.001|TWO_SIDED|95.0|-88.902|-64.593|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.593|-88.902|<0.001
71920533|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-100.666|STANDARD_ERROR_OF_MEAN|6.098|<|0.001|TWO_SIDED|95.0|-112.781|-88.551|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-88.551|-112.781|<0.001
71920534|NCT02055976|143362598|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-109.49|STANDARD_ERROR_OF_MEAN|6.054|<|0.001|TWO_SIDED|95.0|-121.519|-97.462|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-97.462|-121.519|<0.001
71920535|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.772|STANDARD_ERROR_OF_MEAN|3.473|<|0.001|TWO_SIDED|95.0|-53.671|-39.874|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-39.874|-53.671|<0.001
71920536|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-59.2|STANDARD_ERROR_OF_MEAN|3.554|<|0.001|TWO_SIDED|95.0|-66.257|-52.143|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-52.143|-66.257|<0.001
71920537|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.868|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-74.007|-59.73|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.730|-74.007|<0.001
71920538|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.051|STANDARD_ERROR_OF_MEAN|3.595|<|0.001|TWO_SIDED|95.0|-47.195|-32.908|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-32.908|-47.195|<0.001
71687521|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.406||0.9884||95.0|-0.9|0.91|||ANOVA|||Difference from placebo (including Baseline), Day 8: 36 hours post-dose.||0.91|-0.90|0.9884
71687522|NCT00978341|142891824|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.354||0.8082||95.0|-0.87|0.69|||ANOVA|||Difference from placebo (including Baseline), Day 8: 48 hours post-dose.||0.69|-0.87|0.8082
71687523|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.714||0.2101||95.0|-2.39|0.55|||ANOVA|||Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models.||0.55|-2.39|0.2101
71687524|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|0.623||0.1065||95.0|-2.33|0.24|||ANOVA|||Difference from placebo (including baseline); Day 3.||0.24|-2.33|0.1065
71687525|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.254||0.0697||95.0|-1.11|0.05|||ANOVA|||Difference from placebo (including baseline); Day 4.||0.05|-1.11|0.0697
71687526|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.65||0.4589||95.0|-1.83|0.85|||ANOVA|||Difference from placebo; Day 5.||0.85|-1.83|0.4589
71687527|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.742||0.1326||95.0|-2.69|0.38|||ANOVA|||Difference from placebo; Day 6.||0.38|-2.69|0.1326
71687528|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.638||0.282||95.0|-2.45|0.9|||ANOVA|||Difference from placebo (including baseline); Day 7.||0.90|-2.45|0.2820
71687529|NCT00978341|142891825|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|0.356||0.0108||95.0|-2.21|-0.44|||ANOVA|||Difference from placebo (including baseline); Day 8.||-0.44|-2.21|0.0108
71687530|NCT00978341|142891826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.26|STANDARD_ERROR_OF_MEAN|19.06||0.9068||95.0|-41.78|37.27|||ANOVA|||Difference from placebo; Day 1: 4 hours post-dose (including Baseline).||37.27|-41.78|0.9068
71687531|NCT00978341|142891826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.52|STANDARD_ERROR_OF_MEAN|15.813||0.7807||95.0|-30.53|39.57|||ANOVA|||Difference from placebo; Day 8: pre-dose (including Baseline).||39.57|-30.53|0.7807
71687532|NCT00978341|142891826|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.51|STANDARD_ERROR_OF_MEAN|17.526||0.2293||95.0|-61.79|16.78|||ANOVA|||Difference from placebo; Day 8: 4 hours post-dose (including Baseline).||16.78|-61.79|0.2293
71687533|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.386||0.3774||95.0|-0.54|1.27|||ANOVA|||Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose.||1.27|-0.54|0.3774
71687534|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.215||0.4153||95.0|-0.33|0.7|||ANOVA|||Difference from placebo (including Baseline); Day 1: 1 hour post-dose.||0.70|-0.33|0.4153
71687535|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48||||0.147||95.0|-0.23|1.2|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||1.20|-0.23|0.1470
71687536|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.3||0.1862||95.0|-1.18|0.29|||ANOVA|||Difference from placebo (including Baseline); Day 1: 3 hours post-dose.||0.29|-1.18|0.1862
71687537|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.22||0.8321||95.0|-0.45|0.55|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.55|-0.45|0.8321
71687538|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.269||0.4251||95.0|-0.42|0.88|||ANOVA|||Difference from placebo (including Baseline); Day 1: 5 hours post-dose.||0.88|-0.42|0.4251
71687539|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.269||0.6394||95.0|-0.53|0.8|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.80|-0.53|0.6394
71687540|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.302||0.9964||95.0|-0.68|0.68|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.68|-0.68|0.9964
71687541|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|0.324||0.3638||95.0|-0.47|1.11|||ANOVA|||Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose.||1.11|-0.47|0.3638
71687542|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.223||0.1202||95.0|-0.15|0.99|||ANOVA|||Difference from placebo (including Baseline); Day 8: 1 hour post-dose.||0.99|-0.15|0.1202
71687543|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.355||0.1204||95.0|-0.19|1.39|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||1.39|-0.19|0.1204
71687544|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.289||0.4213||95.0|-0.44|0.93|||ANOVA|||Difference from placebo (including Baseline); Day 8: 3 hours post-dose.||0.93|-0.44|0.4213
71687545|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.205||0.6028||95.0|-0.34|0.56|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.56|-0.34|0.6028
71687546|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.491||0.3624||95.0|-0.68|1.64|||ANOVA|||Difference from placebo (including Baseline); Day 8: 5 hours post-dose.||1.64|-0.68|0.3624
71687547|NCT00978341|142891827|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.461||0.3163||95.0|-0.52|1.49|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||1.49|-0.52|0.3163
71687548|NCT00978341|142891828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|9.738||0.5919||95.0|-16.26|27.04|||ANOVA|||Difference from placebo (including Baseline); Day 1.||27.04|-16.26|0.5919
71920539|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.009|STANDARD_ERROR_OF_MEAN|3.587|<|0.001|TWO_SIDED|95.0|-63.135|-48.882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.882|-63.135|<0.001
71920540|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-57.576|STANDARD_ERROR_OF_MEAN|3.544|<|0.001|TWO_SIDED|95.0|-64.618|-50.533|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-50.533|-64.618|<0.001
71920541|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-37.991|STANDARD_ERROR_OF_MEAN|3.389|<|0.001|TWO_SIDED|95.0|-44.721|-31.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.260|-44.721|<0.001
71920542|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-50.856|STANDARD_ERROR_OF_MEAN|3.451|<|0.001|TWO_SIDED|95.0|-57.709|-44.002|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-44.002|-57.709|<0.001
71920543|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.354|STANDARD_ERROR_OF_MEAN|3.505|<|0.001|TWO_SIDED|95.0|-63.315|-49.393|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.393|-63.315|<0.001
71920544|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.172|STANDARD_ERROR_OF_MEAN|3.647|<|0.001|TWO_SIDED|95.0|-50.417|-35.926|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.926|-50.417|<0.001
71920545|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.698|STANDARD_ERROR_OF_MEAN|3.633|<|0.001|TWO_SIDED|95.0|-63.916|-49.48|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.480|-63.916|<0.001
71920546|NCT02055976|143362599|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.305|STANDARD_ERROR_OF_MEAN|3.609|<|0.001|TWO_SIDED|95.0|-68.477|-54.134|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.134|-68.477|<0.001
71920547|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.69928|STANDARD_ERROR_OF_MEAN|0.13216|<|0.001|TWO_SIDED|95.0|-1.96175|-1.43682|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.43682|-1.96175|<0.001
71920548|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.07922|STANDARD_ERROR_OF_MEAN|0.13446|<|0.001|TWO_SIDED|95.0|-2.34622|-1.81223|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.81223|-2.34622|<0.001
71920549|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.23886|STANDARD_ERROR_OF_MEAN|0.13553|<|0.001|TWO_SIDED|95.0|-2.50795|-1.96978|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.96978|-2.50795|<0.001
71920550|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.43281|STANDARD_ERROR_OF_MEAN|0.16311|<|0.001|TWO_SIDED|95.0|-1.75689|-1.10872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.10872|-1.75689|<0.001
71920551|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.01501|STANDARD_ERROR_OF_MEAN|0.16217|<|0.001|TWO_SIDED|95.0|-2.33718|-1.69283|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.69283|-2.33718|<0.001
71920552|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.11359|STANDARD_ERROR_OF_MEAN|0.16038|<|0.001|TWO_SIDED|95.0|-2.4323|-1.79489|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.79489|-2.43230|<0.001
71687549|NCT00978341|142891828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.58|STANDARD_ERROR_OF_MEAN|14.603||0.3981||95.0|-17.7|42.87|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||42.87|-17.70|0.3981
71687550|NCT00978341|142891828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.64|STANDARD_ERROR_OF_MEAN|12.123||0.8314||95.0|-24.0|29.28|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||29.28|-24.00|0.8314
71920553|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.35298|STANDARD_ERROR_OF_MEAN|0.13609|<|0.001|TWO_SIDED|95.0|-1.62324|-1.08271|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.08271|-1.62324|<0.001
71920554|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.79615|STANDARD_ERROR_OF_MEAN|0.1379|<|0.001|TWO_SIDED|95.0|-2.07001|-1.52229|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.52229|-2.07001|<0.001
71920555|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.86921|STANDARD_ERROR_OF_MEAN|0.13927|<|0.001|TWO_SIDED|95.0|-2.14575|-1.59266|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.59266|-2.14575|<0.001
71920556|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.57311|STANDARD_ERROR_OF_MEAN|0.14333|<|0.001|TWO_SIDED|95.0|-1.85788|-1.28834|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.28834|-1.85788|<0.001
71920557|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.00256|STANDARD_ERROR_OF_MEAN|0.14228|<|0.001|TWO_SIDED|95.0|-2.28521|-1.7199|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.71990|-2.28521|<0.001
71920558|NCT02055976|143362601|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.20298|STANDARD_ERROR_OF_MEAN|0.14142|<|0.001|TWO_SIDED|95.0|-2.48399|-1.92197|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-1.92197|-2.48399|<0.001
71920559|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-41.92915|STANDARD_ERROR_OF_MEAN|2.83037|<|0.001|TWO_SIDED|95.0|-47.55052|-36.30778|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-36.30778|-47.55052|<0.001
71920560|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.08604|STANDARD_ERROR_OF_MEAN|2.88356|<|0.001|TWO_SIDED|95.0|-56.81235|-45.35973|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.35973|-56.81235|<0.001
71920561|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-55.516|STANDARD_ERROR_OF_MEAN|2.91014|<|0.001|TWO_SIDED|95.0|-61.29424|-49.73777|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-49.73777|-61.29424|<0.001
71920562|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.30375|STANDARD_ERROR_OF_MEAN|3.07498|<|0.001|TWO_SIDED|95.0|-39.41376|-27.19373|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.19373|-39.41376|<0.001
71920563|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-47.8521|STANDARD_ERROR_OF_MEAN|3.05746|<|0.001|TWO_SIDED|95.0|-53.92668|-41.77751|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-41.77751|-53.92668|<0.001
71920564|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.65686|STANDARD_ERROR_OF_MEAN|3.02097|<|0.001|TWO_SIDED|95.0|-54.6606|-42.65313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.65313|-54.66060|<0.001
71920565|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-33.5292|STANDARD_ERROR_OF_MEAN|2.96599|<|0.001|TWO_SIDED|95.0|-39.42015|-27.63826|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-27.63826|-39.42015|<0.001
71922471|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|6.1||||0.18|TWO_SIDED|95.0|-3.4|15.6|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.6|-3.4|0.180
71920566|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.8568|STANDARD_ERROR_OF_MEAN|3.00531|<|0.001|TWO_SIDED|95.0|-49.82617|-37.88744|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-37.88744|-49.82617|<0.001
71920567|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.36865|STANDARD_ERROR_OF_MEAN|3.03981|<|0.001|TWO_SIDED|95.0|-52.40589|-40.33142|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-40.33142|-52.40589|<0.001
71920568|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-38.06019|STANDARD_ERROR_OF_MEAN|3.1361|<|0.001|TWO_SIDED|95.0|-44.29176|-31.82863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-31.82863|-44.29176|<0.001
71920569|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-48.57807|STANDARD_ERROR_OF_MEAN|3.1135|<|0.001|TWO_SIDED|95.0|-54.76397|-42.39217|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.39217|-54.76397|<0.001
71920570|NCT02055976|143362602|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-51.87214|STANDARD_ERROR_OF_MEAN|3.09363|<|0.001|TWO_SIDED|95.0|-58.01968|-45.7246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-45.72460|-58.01968|<0.001
71920571|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.33157|STANDARD_ERROR_OF_MEAN|0.02639|<|0.001|TWO_SIDED|95.0|-0.38399|-0.27916|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.27916|-0.38399|<0.001
71920572|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44402|STANDARD_ERROR_OF_MEAN|0.02682|<|0.001|TWO_SIDED|95.0|-0.49727|-0.39077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39077|-0.49727|<0.001
71880767|NCT02819635|143280718|SUPERIORITY||Adjusted risk difference (%)|34.4|||<|0.001|TWO_SIDED|95.0|25.1|43.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||43.7|25.1|<0.001
71880768|NCT02819635|143280718|SUPERIORITY||Adjusted risk difference (%)|46.3|||<|0.001|TWO_SIDED|95.0|36.7|55.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||55.8|36.7|<0.001
71880769|NCT02819635|143280719|SUPERIORITY||Adjusted risk difference (%)|37.4|||<|0.001|TWO_SIDED|95.0|20.3|54.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.6|20.3|<0.001
71880770|NCT02819635|143280719|SUPERIORITY||Adjusted risk difference (%)|47.0|||<|0.001|TWO_SIDED|95.0|30.7|63.3||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||63.3|30.7|<0.001
71880771|NCT02819635|143280720|SUPERIORITY||Adjusted risk difference (%)|35.4|||<|0.001|TWO_SIDED|95.0|18.2|52.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||52.7|18.2|<0.001
71880772|NCT02819635|143280720|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|28.7|61.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.6|28.7|<0.001
71880773|NCT02819635|143280721|SUPERIORITY||Adjusted risk difference (%)|42.0|||<|0.001|TWO_SIDED|95.0|27.8|56.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||56.2|27.8|<0.001
71880774|NCT02819635|143280721|SUPERIORITY||Adjusted risk difference (%)|48.6|||<|0.001|TWO_SIDED|95.0|35.5|61.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||61.7|35.5|<0.001
71880775|NCT02819635|143280722|SUPERIORITY||Adjusted risk difference (%)|18.7|||<|0.001|TWO_SIDED|95.0|11.0|26.4||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||26.4|11.0|<0.001
71880776|NCT02819635|143280722|SUPERIORITY||Adjusted risk difference (%)|19.4|||<|0.001|TWO_SIDED|95.0|11.7|27.2||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||27.2|11.7|<0.001
71880777|NCT02819635|143280723|SUPERIORITY||Adjusted risk difference (%)|44.6|||<|0.001|TWO_SIDED|95.0|34.5|54.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||54.7|34.5|<0.001
71920573|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.48314|STANDARD_ERROR_OF_MEAN|0.02698|<|0.001|TWO_SIDED|95.0|-0.53671|-0.42956|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.42956|-0.53671|<0.001
71687551|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.054||0.7569||95.0|-0.14|0.1|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.||0.10|-0.14|0.7569
71687552|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4814||95.0|-0.26|0.13|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.||0.13|-0.26|0.4814
71687553|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.143||0.6222||95.0|-0.37|0.23|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.||0.23|-0.37|0.6222
71687554|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.113||0.3035||95.0|-0.35|0.12|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.||0.12|-0.35|0.3035
71687555|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.122||0.1881||95.0|-0.42|0.09|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.||0.09|-0.42|0.1881
71880778|NCT02819635|143280723|SUPERIORITY||Adjusted risk difference (%)|56.6|||<|0.001|TWO_SIDED|95.0|47.2|66.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||66.0|47.2|<0.001
71882924|NCT00477165|143284919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.59|TWO_SIDED|95.0|0.687|1.196||p\<0.05 for statistical significance|t-test, 2 sided||Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.|Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups||1.196|0.687|0.59
71687556|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.072||0.3159||95.0|-0.09|0.24|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.||0.24|-0.09|0.3159
71882925|NCT00105443|143284923|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6931||||0.00583||95.0|0.5549|0.8658||According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).|Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and tumor burden. In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here."||0.8658|0.5549|0.00583
71882926|NCT00105443|143284924|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0764||||0.7676||95.0|0.8837|1.311|||Log Rank||This is the sorafenib to placebo hazard ratio.|"The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and tumor burden. This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study."||1.3110|0.8837|0.7676
71882927|NCT00105443|143284925|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5764||||7e-06||95.0|0.4484|0.741|||Log Rank||This is the sorafenib to placebo hazard ratio.|"In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and tumor burden."||0.7410|0.4484|0.000007
71882928|NCT00105443|143284926|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-11.95||||0.001641||95.0|-19.56|-4.35|||Cochran-Mantel-Haenszel||Sorafenib minus placebo difference|"Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and tumor burden."||-4.35|-19.56|0.001641
71882929|NCT01157078|143284933|SUPERIORITY_OR_OTHER||LS mean|-1.0|STANDARD_ERROR_OF_MEAN|1.08||0.349|TWO_SIDED|95.0|-3.14|1.11||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.11|-3.14|0.349
71882930|NCT01157078|143284934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.29||0.444|TWO_SIDED|95.0|0.75|1.92|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||1.92|0.75|0.444
71882931|NCT01157078|143284935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52|STANDARD_ERROR_OF_MEAN|0.42||0.13|TWO_SIDED|95.0|0.88|2.61|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.61|0.88|0.130
71882932|NCT01157078|143284936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75|STANDARD_ERROR_OF_MEAN|0.96||0.307|TWO_SIDED|95.0|0.6|5.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||5.14|0.60|0.307
71882933|NCT01157078|143284937|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|STANDARD_ERROR_OF_MEAN|0.52||0.313|TWO_SIDED|95.0|0.71|2.94|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||2.94|0.71|0.313
71882934|NCT01157078|143284938|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.77|STANDARD_ERROR_OF_MEAN|0.79||0.201|TWO_SIDED|95.0|0.74|4.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.||4.24|0.74|0.201
71882935|NCT01157078|143284939|SUPERIORITY_OR_OTHER||LS mean|-0.5|STANDARD_ERROR_OF_MEAN|0.82||0.552|TWO_SIDED|95.0|-2.1|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.||1.12|-2.10|0.552
71882936|NCT01157078|143284940|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.803||95.0|-0.31|0.24|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.24|-0.31|0.803
71882937|NCT01157078|143284941|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|STANDARD_ERROR_OF_MEAN|0.28||0.44|TWO_SIDED|95.0|0.75|1.91|||Regression, Logistic||TC-5214 is the numerator in the OR, OR\>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.||1.91|0.75|0.440
71687557|NCT00978341|142891829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.103||0.8203||95.0|-0.22|0.27|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.||0.27|-0.22|0.8203
71687558|NCT03035916|142891832|OTHER|||||||0.454|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.454
71880779|NCT02819635|143280724|SUPERIORITY||Adjusted risk difference (%)|23.8|||<|0.001|TWO_SIDED|95.0|14.8|32.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||32.8|14.8|<0.001
71880780|NCT02819635|143280724|SUPERIORITY||Adjusted risk difference (%)|37.3|||<|0.001|TWO_SIDED|95.0|27.8|46.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||46.8|27.8|<0.001
71920574|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.30542|STANDARD_ERROR_OF_MEAN|0.0323|<|0.001|TWO_SIDED|95.0|-0.3696|-0.24124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.24124|-0.36960|<0.001
71920575|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.44143|STANDARD_ERROR_OF_MEAN|0.03183|<|0.001|TWO_SIDED|95.0|-0.50466|-0.37821|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.37821|-0.50466|<0.001
71920576|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46235|STANDARD_ERROR_OF_MEAN|0.03148|<|0.001|TWO_SIDED|95.0|-0.52491|-0.3998|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39980|-0.52491|<0.001
71920577|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.26949|STANDARD_ERROR_OF_MEAN|0.02615|<|0.001|TWO_SIDED|95.0|-0.32142|-0.21755|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.21755|-0.32142|<0.001
71920578|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.37493|STANDARD_ERROR_OF_MEAN|0.02649|<|0.001|TWO_SIDED|95.0|-0.42754|-0.32231|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.32231|-0.42754|<0.001
71920579|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.41199|STANDARD_ERROR_OF_MEAN|0.02676|<|0.001|TWO_SIDED|95.0|-0.46512|-0.35886|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.35886|-0.46512|<0.001
71920580|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.31806|STANDARD_ERROR_OF_MEAN|0.02979|<|0.001|TWO_SIDED|95.0|-0.37723|-0.25888|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.25888|-0.37723|<0.001
71920581|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.42583|STANDARD_ERROR_OF_MEAN|0.02932|<|0.001|TWO_SIDED|95.0|-0.48409|-0.36758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.36758|-0.48409|<0.001
71920582|NCT02055976|143362604|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.45501|STANDARD_ERROR_OF_MEAN|0.02912|<|0.001|TWO_SIDED|95.0|-0.51287|-0.39715|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-0.39715|-0.51287|<0.001
71920583|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-49.42411|STANDARD_ERROR_OF_MEAN|3.72907|<|0.001|TWO_SIDED|95.0|-56.83019|-42.01803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-42.01803|-56.83019|<0.001
71920584|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-66.63383|STANDARD_ERROR_OF_MEAN|3.7905|<|0.001|TWO_SIDED|95.0|-74.16086|-59.10681|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-59.10681|-74.16086|<0.001
71920585|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-71.72901|STANDARD_ERROR_OF_MEAN|3.81541|<|0.001|TWO_SIDED|95.0|-79.30431|-64.15371|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-64.15371|-79.30431|<0.001
71687559|NCT03035916|142891832|OTHER|||||||0.402|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.402
71687560|NCT03035916|142891832|OTHER|||||||0.901|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.901
71687561|NCT03035916|142891832|OTHER|||||||0.54|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.540
71687562|NCT03035916|142891832|OTHER|||||||0.523|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.523
71920586|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-43.56596|STANDARD_ERROR_OF_MEAN|3.92236|<|0.001|TWO_SIDED|95.0|-51.35899|-35.77293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-35.77293|-51.35899|<0.001
71687563|NCT03035916|142891832|OTHER|||||||0.26|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.260
71687564|NCT03035916|142891832|OTHER|||||||0.139|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.139
71687565|NCT03035916|142891832|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687566|NCT03035916|142891832|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687567|NCT03035916|142891832|OTHER|||||||0.464|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.464
71687568|NCT03035916|142891832|OTHER|||||||0.007|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.007
71687569|NCT03035916|142891832|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687570|NCT03035916|142891832|OTHER|||||||0.411|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.411
71687571|NCT03035916|142891832|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687572|NCT03035916|142891832|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71920587|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-62.34926|STANDARD_ERROR_OF_MEAN|3.86432|<|0.001|TWO_SIDED|95.0|-70.02607|-54.67245|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.67245|-70.02607|<0.001
71922472|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-2.7||||0.277|TWO_SIDED|95.0|-6.5|1.1|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||1.1|-6.5|0.277
71687573|NCT03035916|142891833|OTHER|||||||0.412|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.412
71687574|NCT03035916|142891833|OTHER|||||||0.592|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.592
71687575|NCT03035916|142891833|OTHER|||||||0.796|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."||||0.796
71687576|NCT03035916|142891833|OTHER|||||||0.576|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.576
71687577|NCT03035916|142891833|OTHER|||||||0.427|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.427
71687578|NCT03035916|142891833|OTHER|||||||0.201|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."||||0.201
71920588|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-65.06617|STANDARD_ERROR_OF_MEAN|3.82052|<|0.001|TWO_SIDED|95.0|-72.65818|-57.47415|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-57.47415|-72.65818|<0.001
71920589|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-40.52435|STANDARD_ERROR_OF_MEAN|3.66973|<|0.001|TWO_SIDED|95.0|-47.81299|-33.23571|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-33.23571|-47.81299|<0.001
71920590|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-56.14495|STANDARD_ERROR_OF_MEAN|3.71641|<|0.001|TWO_SIDED|95.0|-63.52668|-48.76322|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-48.76322|-63.52668|<0.001
71920591|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.5637|STANDARD_ERROR_OF_MEAN|3.7569|<|0.001|TWO_SIDED|95.0|-69.0251|-54.1023|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-54.10230|-69.02510|<0.001
71920592|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-46.34109|STANDARD_ERROR_OF_MEAN|4.16385|<|0.001|TWO_SIDED|95.0|-54.61427|-38.06792|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-38.06792|-54.61427|<0.001
71920593|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-61.3789|STANDARD_ERROR_OF_MEAN|4.09957|<|0.001|TWO_SIDED|95.0|-69.52338|-53.23443|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-53.23443|-69.52338|<0.001
71920594|NCT02055976|143362605|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-64.67274|STANDARD_ERROR_OF_MEAN|4.06866|<|0.001|TWO_SIDED|95.0|-72.75728|-56.5882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.||-56.58820|-72.75728|<0.001
71920595|NCT00394654|143362617|SUPERIORITY_OR_OTHER|||||||0.168|||||||Univariate 2-sample t-test|||||||0.168
71920596|NCT00394654|143362618|SUPERIORITY_OR_OTHER|||||||0.254|||||||Univariate 2-sample t-test|||||||0.254
71920597|NCT00394654|143362619|SUPERIORITY_OR_OTHER|||||||0.677|||||||Univariate 2-sample t-test|||||||0.677
71920598|NCT00394654|143362620|SUPERIORITY_OR_OTHER|||||||0.318|||||||Univariate 2-sample t-test|||||||0.318
71920599|NCT00394654|143362621|SUPERIORITY_OR_OTHER|||||||0.798|||||||Univariate 2-sample t-test|||||||0.798
71920600|NCT00394654|143362622|SUPERIORITY_OR_OTHER|||||||0.766|||||||Univariate 2-sample t-test|||||||0.766
71920601|NCT03756285|143362651|SUPERIORITY||Least Square Means Ratio|0.25|||<|0.001|TWO_SIDED|95.0|0.12|0.52|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||0.52|0.12|<0.001
71920602|NCT03756285|143362652|SUPERIORITY||Least Square Means Ratio|0.97||||0.568|ONE_SIDED|95.0|0.74||||ANCOVA|Covariates: atrial fibrillation status at randomization, baseline value, treatment|||||0.74|0.568
71920603|NCT03756285|143362653|SUPERIORITY||Mean Difference (Final Values)|21.8||||0.407|TWO_SIDED|95.0|-30.5|74.1|||Mixed Models Analysis|Covariates: atrial fibrillation status at randomization, baseline value, treatment, visit, and treatment\*visit.||||74.1|-30.5|0.407
71920604|NCT02705755|143362664|SUPERIORITY||Least Squares Mean Difference|-4.4||||0.0399|TWO_SIDED|95.0|-8.57|-0.23||P-values were reported without multiplicity adjustment.|Repeated-measures Mixed-effect Model|||Least squares mean differences were calculated based on a repeated-measures mixed-effect model with change from baseline at different time points as the dependent variable, the treatment group (TD-9855 or placebo), time point, baseline and the interaction between the treatment group and time point as fixed factors. A compound symmetry was used as the variance-covariance structure.||-0.23|-8.57|0.0399
71920605|NCT01084096|143362672|SUPERIORITY|Trial powered to detect a 30% reduction in 28-d NM among \<5th %tile for birth weight infants. We used an intention-to-treat approach, with a model-based adaptation of the permutation test. We fitted an individual-level linear model with 28-d NM by site and randomization strata, nested within site, and computed the residual for each individual and mean cluster-level residuals. Next, we used an ANOVA model to test for trt differences between mean residuals for intervention and control clusters.|Risk Ratio (RR)|0.96||||0.65|TWO_SIDED|95.0|0.87|1.06|||t-test, 2 sided|Cluster-level with 62 degrees of freedom \[101 clusters-37 strata-2 treatment groups\].|Calculated from generalized linear models accounting for the cluster-level variance and adjusted for randomization strata. Each stratum corresponds to 2-4 clusters within the site with equal distribution to treatment and control arms.|||1.06|0.87|0.65
71920606|NCT01084096|143362673|SUPERIORITY||Risk Difference (RD)|0.3546|||<|0.0001|TWO_SIDED|95.0|0.3299|0.3792|||Cochran-Mantel-Haenszel|P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Risk difference represents risk in the intervention clusters minus the risk in the control clusters.|The trial was powered to detect a 30% reduction in 28-day neonatal mortality among infants born at less than the 5th percentile of birth weight, based on previous research and an expected increase from 10% to 50% in the use of antenatal corticosteroids among women at risk of preterm birth in the intervention group.||0.3792|0.3299|<0.0001
71920607|NCT01084096|143362674|OTHER|Descriptive analysis.|Odds Ratio (OR)|1.45|||<|0.0001|TWO_SIDED|95.0|1.33|1.58||P-values were calculated from Cochran-Mantel-Haenszel test controlling for randomization strata.|Cochran-Mantel-Haenszel|||||1.58|1.33|<0.0001
71687579|NCT03035916|142891833|OTHER|||||||0.872|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.872
71687580|NCT03035916|142891833|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687581|NCT03035916|142891833|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687582|NCT03035916|142891833|OTHER|||||||0.165|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.165
71687583|NCT03035916|142891833|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687584|NCT03035916|142891833|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687585|NCT03035916|142891833|OTHER|||||||0.305|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.305
71687586|NCT03035916|142891833|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687587|NCT03035916|142891833|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687588|NCT03035916|142891834|OTHER|||||||0.673|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.673
71687589|NCT03035916|142891834|OTHER|||||||0.824|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.824
71687590|NCT03035916|142891834|OTHER|||||||0.547|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.547
71687591|NCT03035916|142891834|OTHER|||||||0.303|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.303
71687592|NCT03035916|142891834|OTHER|||||||0.026|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.026
71687593|NCT03035916|142891834|OTHER|||||||0.002|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.002
71687594|NCT03035916|142891834|OTHER|||||||0.057|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.057
71687595|NCT03035916|142891834|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687596|NCT03035916|142891834|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71920608|NCT01084096|143362676|SUPERIORITY||Risk Ratio (RR)|1.12||||0.0127|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0127
71920609|NCT01084096|143362677|OTHER|Descriptive analysis.|Risk Ratio (RR)|1.11||||0.0181|TWO_SIDED|95.0|1.02|1.22||P-value calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated p value was adjusted for randomization strata.|Generalized linear model with GEE||Relative risk calculated from a generalized linear model with generalized estimating equations to estimate parameters while controlling for cluster correlations. Model-generated measure of risk was adjusted for randomization strata.|||1.22|1.02|0.0181
71920610|NCT04450394|143362712|NON_INFERIORITY|The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% Confidence Interval is below 0.4.|LS Mean Difference|0.06|||||TWO_SIDED|90.0|-0.11|0.24||||||||0.24|-0.11|
71920611|NCT00836342|143362716|SUPERIORITY_OR_OTHER|||||||0.31|||||||t-test, 2 sided|||Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.||||0.31
71920612|NCT00836342|143362717|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
71920613|NCT00836342|143362718|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||t-test, 2 sided|||||||0.09
71920614|NCT02155660|143362720|SUPERIORITY||Rate ratio|0.85||||0.0638|TWO_SIDED|95.0|0.71|1.01|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.01|0.71|0.0638
71920615|NCT02155660|143362720|SUPERIORITY||Rate ratio|1.04||||0.6575|TWO_SIDED|95.0|0.88|1.23|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.23|0.88|0.6575
71920616|NCT02155660|143362720|SUPERIORITY||Rate ratio|0.93||||0.3988|TWO_SIDED|95.0|0.78|1.1|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.10|0.78|0.3988
71920617|NCT02155660|143362721|SUPERIORITY||Rate ratio|1.04||||0.7564|TWO_SIDED|95.0|0.82|1.32|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.32|0.82|0.7564
71920618|NCT02155660|143362721|SUPERIORITY||Rate ratio|1.08||||0.5573|TWO_SIDED|95.0|0.84|1.37|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.37|0.84|0.5573
71920619|NCT02155660|143362721|SUPERIORITY||Rate ratio|1.02||||0.8644|TWO_SIDED|95.0|0.8|1.3|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.||||1.30|0.80|0.8644
71920620|NCT02155660|143362722|SUPERIORITY||Mean Difference (Final Values)|0.015||||0.5043|TWO_SIDED|95.0|-0.029|0.059|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.059|-0.029|0.5043
71920621|NCT02155660|143362722|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.7691|TWO_SIDED|95.0|-0.051|0.037|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.037|-0.051|0.7691
71920622|NCT02155660|143362722|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.3767|TWO_SIDED|95.0|-0.024|0.064|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.064|-0.024|0.3767
71920623|NCT02155660|143362723|SUPERIORITY||Mean Difference (Final Values)|-1.011||||0.3636|TWO_SIDED|95.0|-3.192|1.171|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.171|-3.192|0.3636
71920624|NCT02155660|143362723|SUPERIORITY||Mean Difference (Final Values)|-1.388||||0.2106|TWO_SIDED|95.0|-3.562|0.786|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.786|-3.562|0.2106
71687597|NCT03035916|142891834|OTHER|||||||0.069|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.069
71687598|NCT03035916|142891834|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687599|NCT03035916|142891834|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687600|NCT03035916|142891834|OTHER|||||||0.561|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.561
71687601|NCT03035916|142891834|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687602|NCT03035916|142891834|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687603|NCT03035916|142891835|OTHER|||||||0.249|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.249
71920625|NCT02155660|143362723|SUPERIORITY||Mean Difference (Final Values)|-0.602||||0.5851|TWO_SIDED|95.0|-2.763|1.56|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||1.560|-2.763|0.5851
71920626|NCT02155660|143362724|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.8525|TWO_SIDED|95.0|-0.82|0.99|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.99|-0.82|0.8525
71920627|NCT02155660|143362724|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.987|TWO_SIDED|95.0|-0.91|0.89|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.89|-0.91|0.9870
71920628|NCT02155660|143362724|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.8204|TWO_SIDED|95.0|-1.0|0.79|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.79|-1.00|0.8204
71920629|NCT02155660|143362725|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.2636|TWO_SIDED|95.0|-1.102|0.301|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.301|-1.102|0.2636
71920630|NCT02155660|143362725|SUPERIORITY||Mean Difference (Final Values)|-0.296||||0.4087|TWO_SIDED|95.0|-0.998|0.406|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.406|-0.998|0.4087
71920631|NCT02155660|143362725|SUPERIORITY||Mean Difference (Final Values)|-0.425||||0.2336|TWO_SIDED|95.0|-1.125|0.275|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.275|-1.125|0.2336
71920632|NCT02155660|143362726|SUPERIORITY||Mean Difference (Final Values)|-0.642||||0.0012|TWO_SIDED|95.0|-1.029|-0.254|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.254|-1.029|0.0012
71920633|NCT02155660|143362726|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.0852|TWO_SIDED|95.0|-0.727|0.047|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.047|-0.727|0.0852
71920634|NCT02155660|143362726|SUPERIORITY||Mean Difference (Final Values)|-0.364||||0.065|TWO_SIDED|95.0|-0.75|0.023|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.023|-0.750|0.0650
71920635|NCT02155660|143362727|SUPERIORITY||Mean Difference (Final Values)|-0.041||||0.0415|TWO_SIDED|95.0|-0.081|-0.002|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.002|-0.081|0.0415
71920636|NCT02155660|143362727|SUPERIORITY||Mean Difference (Final Values)|-0.055||||0.0069|TWO_SIDED|95.0|-0.094|-0.015|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||-0.015|-0.094|0.0069
71920637|NCT02155660|143362727|SUPERIORITY||Mean Difference (Final Values)|-0.026||||0.2008|TWO_SIDED|95.0|-0.065|0.014|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.||||0.014|-0.065|0.2008
71920638|NCT02155660|143362731|SUPERIORITY||Rate ratio|0.98||||0.8158|TWO_SIDED|95.0|0.81|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.81|0.8158
71920639|NCT02155660|143362731|SUPERIORITY||Rate ratio|0.98||||0.8378|TWO_SIDED|95.0|0.82|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.18|0.82|0.8378
71920640|NCT02155660|143362731|SUPERIORITY||Rate ratio|0.92||||0.3759|TWO_SIDED|95.0|0.76|1.11|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.||||1.11|0.76|0.3759
71920641|NCT02155660|143362732|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9141|TWO_SIDED|95.0|0.76|1.36|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.36|0.76|0.9141
71920642|NCT02155660|143362732|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0323|TWO_SIDED|95.0|1.03|1.87|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.87|1.03|0.0323
71882938|NCT01157078|143284942|SUPERIORITY_OR_OTHER||LS mean|0.2|STANDARD_ERROR_OF_MEAN|0.55||0.768|TWO_SIDED|95.0|-0.91|1.23||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.23|-0.91|0.768
71687604|NCT03035916|142891835|OTHER|||||||0.091|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.091
71687605|NCT03035916|142891835|OTHER|||||||0.493|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.493
71687606|NCT03035916|142891835|OTHER|||||||0.067|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.067
71687607|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
71687608|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."||||0.001
71687609|NCT03035916|142891835|OTHER|||||||0.079|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.079
71687610|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687611|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687612|NCT03035916|142891835|OTHER|||||||0.314||||||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.314
71687613|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687614|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687615|NCT03035916|142891835|OTHER|||||||0.087|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.087
71687616|NCT03035916|142891835|OTHER|||||||0.023|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.023
71687617|NCT03035916|142891835|OTHER|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687618|NCT03035916|142891836|OTHER|||||||0.384|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.384
71687619|NCT03035916|142891836|OTHER|||||||0.53|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.530
71687620|NCT03035916|142891836|OTHER|||||||0.819|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.819
71880781|NCT02819635|143280725|SUPERIORITY||LS Mean Difference|31.3|STANDARD_ERROR_OF_MEAN|4.77|<|0.001|TWO_SIDED|95.0|21.98|40.7||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||40.70|21.98|<0.001
71687621|NCT03035916|142891836|OTHER|||||||0.108|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.108
71882939|NCT01157078|143284943|SUPERIORITY_OR_OTHER||LS mean|0.7|STANDARD_ERROR_OF_MEAN|0.78||0.373|TWO_SIDED|95.0|-0.84|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.24|-0.84|0.373
71687622|NCT03035916|142891836|OTHER|||||||0.667|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.667
71687623|NCT03035916|142891836|OTHER|||||||0.046|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.046
71687624|NCT03035916|142891836|OTHER|||||||0.006|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.006
71687625|NCT03035916|142891836|OTHER|||||||0.406|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.406
71687626|NCT03035916|142891836|OTHER|||||||0.042|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.042
71687627|NCT03035916|142891836|OTHER|||||||0.655|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.655
71687628|NCT03035916|142891836|OTHER|||||||0.262|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.262
71687629|NCT03035916|142891836|OTHER|||||||0.143|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.143
71687630|NCT03035916|142891836|OTHER|||||||0.494|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.494
71687631|NCT03035916|142891836|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71687632|NCT03035916|142891836|OTHER|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71687633|NCT03035916|142891836|OTHER|||||||0.555|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
71687634|NCT03035916|142891836|OTHER|||||||0.411|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.411
71687635|NCT03035916|142891836|OTHER|||||||0.167|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.167
71687636|NCT03035916|142891836|OTHER|||||||0.445|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.445
71687637|NCT03035916|142891836|OTHER|||||||0.489|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.489
71687638|NCT03035916|142891836|OTHER|||||||0.159|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.159
71687639|NCT03035916|142891836|OTHER|||||||0.72|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.720
71687640|NCT03035916|142891836|OTHER|||||||0.026|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.026
71687641|NCT03035916|142891836|OTHER|||||||0.011|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.011
71687642|NCT03035916|142891836|OTHER|||||||0.763|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.763
71687643|NCT03035916|142891836|OTHER|||||||0.187|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.187
71687644|NCT03035916|142891836|OTHER|||||||0.112|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.112
71687645|NCT03035916|142891837|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
71687646|NCT03035916|142891837|OTHER|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.645
71687647|NCT03035916|142891837|OTHER|||||||0.314|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."||||0.314
71687648|NCT03035916|142891837|OTHER|||||||0.003|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.003
71687649|NCT03035916|142891837|OTHER|||||||0.367|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.367
71687650|NCT03035916|142891837|OTHER|||||||0.031|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."||||0.031
71687651|NCT03035916|142891837|OTHER|||||||0.009|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.009
71920643|NCT02155660|143362732|SUPERIORITY||Odds Ratio (OR)|1.1||||0.5109|TWO_SIDED|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with \>=1 COPD exacerbation.||1.48|0.82|0.5109
71920644|NCT02155660|143362734|SUPERIORITY||Rate ratio|0.68||||0.0287|TWO_SIDED|95.0|0.49|0.96|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.96|0.49|0.0287
71920645|NCT02155660|143362734|SUPERIORITY||Rate ratio|0.89||||0.4631|TWO_SIDED|95.0|0.65|1.22|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||1.22|0.65|0.4631
71920646|NCT02155660|143362734|SUPERIORITY||Rate ratio|0.67||||0.0185|TWO_SIDED|95.0|0.48|0.94|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).||||0.94|0.48|0.0185
71920647|NCT01192139|143362739|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin|Ratio of Geometric Least Squares Means|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.068|1.011|
71920648|NCT01192139|143362739|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Means|1.078|||||TWO_SIDED|90.0|1.049|1.108|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.108|1.049|
71920649|NCT01192139|143362739|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|104.65||||||95.0||||||||Geometric least squares means for treatment A||||
71687652|NCT03035916|142891837|OTHER|||||||0.873|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.873
71920650|NCT01192139|143362739|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|108.74||||||95.0||||||||Geometric least squares means for treatment B||||
71920651|NCT01192139|143362739|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|100.84||||||95.0||||||||Geometric least squares mean for treatment C||||
71920652|NCT01192139|143362741|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|1.039|||||TWO_SIDED|90.0|1.011|1.068|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||1.068|1.011|
71920653|NCT01192139|143362741|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.08|||||TWO_SIDED|90.0|1.051|1.11|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.110|1.051|
71920654|NCT01192139|143362741|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|102.84||||||95.0||||||||Geometric least squares mean for treatment A||||
71920655|NCT01192139|143362741|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|106.89||||||95.0||||||||Geometric least squares mean for treatment B||||
71920656|NCT01192139|143362741|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|98.99||||||95.0||||||||Geometric least squares mean for treatment C||||
71922473|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.7||||0.74|TWO_SIDED|95.0|-7.9|11.3|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.3|-7.9|0.740
71922474|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.4||||0.934|TWO_SIDED|95.0|-9.3|10.1|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||10.1|-9.3|0.934
71922475|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.6||||0.876|TWO_SIDED|95.0|-7.7|6.4|||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.4|-7.7|0.876
71922476|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.1||||0.842|TWO_SIDED|95.0|-11.4|9.2|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.2|-11.4|0.842
71922477|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.1||||0.509|TWO_SIDED|95.0|-8.1|16.3|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||16.3|-8.1|0.509
71922478|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.504|TWO_SIDED|95.0|-7.0|15.0|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||15.0|-7.0|0.504
71922479|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.373|TWO_SIDED|95.0|-6.3|17.0|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||17.0|-6.3|0.373
71687653|NCT03035916|142891837|OTHER|||||||0.026|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."||||0.026
71920657|NCT01192139|143362742|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of Geometric Least Squares Means|1.021|||||TWO_SIDED|90.0|0.94|1.109|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.109|0.940|
71920658|NCT01192139|143362742|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the fed to fasted ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin.|Ratio of Geometric Least Squares Means|0.949|||||TWO_SIDED|90.0|0.873|1.031|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.031|0.873|
71920659|NCT01192139|143362742|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|25.68||||||95.0||||||||Geometric least squares mean for treatment A||||
71920660|NCT01192139|143362742|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|26.21||||||95.0||||||||Geometric least squares mean for treatment B||||
71920661|NCT01192139|143362742|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|27.63||||||95.0||||||||Geometric least squares mean for treatment C||||
71920662|NCT01192139|143362751|NON_INFERIORITY_OR_EQUIVALENCE|BE concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Geometric Means|0.915|||||TWO_SIDED|90.0|0.836|1.002|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.002|0.836|
71920663|NCT01192139|143362751|NON_INFERIORITY_OR_EQUIVALENCE|lack of food effect concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Geometric LS Mean and 90% CI|1.01|||||TWO_SIDED|90.0|0.918|1.111|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.111|0.918|
71920664|NCT01192139|143362751|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5542.2||||||95.0||||||||Geometric least squares means for treatment A||||
71920665|NCT01192139|143362751|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5072.9||||||95.0||||||||Geometric least squares mean for treatment B||||
71920666|NCT01192139|143362751|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5023.3||||||95.0||||||||Geometric least squares mean for treatment C||||
71920667|NCT01192139|143362752|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Mean|0.92|||||TWO_SIDED|90.0|0.854|0.992|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|||0.992|0.854|
71920668|NCT01192139|143362752|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|1.025|||||TWO_SIDED|95.0|0.951|1.105|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||1.105|0.951|
71920669|NCT01192139|143362752|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|5287.1||||||95.0||||||||Geometric least squares means for treatment A||||
71920670|NCT01192139|143362752|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4866.2||||||95.0||||||||Geometric least squares mean for treatment B||||
71920671|NCT01192139|143362752|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|4746.8||||||95.0||||||||Geometric least squares means for treatment C||||
71920672|NCT01192139|143362753|NON_INFERIORITY_OR_EQUIVALENCE|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|Ratio of Geometric Least Squares Means|0.933|||||TWO_SIDED|95.0|0.865|1.007|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.||1.007|0.865|
71920673|NCT01192139|143362753|NON_INFERIORITY_OR_EQUIVALENCE|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(inf) of saxagliptin and metformin.|Ratio of Geometric Least Squares Means|0.898|||||TWO_SIDED|90.0|0.832|0.969|||||Ration = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|||0.969|0.832|
71920674|NCT01192139|143362753|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|608.41||||||95.0||||||||Geometric least squares mean for treatment A||||
71920675|NCT01192139|143362753|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|567.85||||||95.0||||||||Geometric least squares mean for treatment B||||
71920676|NCT01192139|143362753|SUPERIORITY_OR_OTHER||Geometric least squares mean (ng*hr/mL)|632.39||||||95.0||||||||Geometric least squares mean for treatment C||||
71920677|NCT03812224|143362759|SUPERIORITY||LS Mean Difference|-1.62|||<|0.001||95.0|-2.52|-0.73|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type and prior migraine preventive treatment status, and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.73|-2.52|<0.001
71920678|NCT03812224|143362760|SUPERIORITY||Odds Ratio (OR)|2.33||||0.005|TWO_SIDED|95.0|1.29|4.23|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factors of migraine type and prior migraine preventive treatment status.||||4.23|1.29|0.005
71687654|NCT03035916|142891837|OTHER|||||||0.411|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.411
71687655|NCT03035916|142891837|OTHER|||||||0.787|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.787
71687656|NCT03035916|142891837|OTHER|||||||0.306|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."||||0.306
71687657|NCT03035916|142891837|OTHER|||||||0.921|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.921
71687658|NCT03035916|142891837|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71687659|NCT03035916|142891837|OTHER|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."||||0.001
71687660|NCT03035916|142891837|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.555
71687661|NCT03035916|142891837|OTHER|||||||0.058|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.058
71687662|NCT03035916|142891837|OTHER|||||||0.166|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."||||0.166
71687663|NCT03035916|142891837|OTHER|||||||0.288|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.288
71687664|NCT03035916|142891837|OTHER|||||||0.299|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.299
71880782|NCT02819635|143280725|SUPERIORITY||LS Mean Difference|41.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|31.39|50.55||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||50.55|31.39|<0.001
71880783|NCT02819635|143280726|SUPERIORITY||Adjusted risk difference (%)|13.0|||<|0.001|TWO_SIDED|95.0|6.0|20.0||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||20.0|6.0|<0.001
71687665|NCT03035916|142891837|OTHER|||||||0.051|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."||||0.051
71687666|NCT03035916|142891837|OTHER|||||||0.186|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.186
71687667|NCT03035916|142891837|OTHER|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.555
71687668|NCT03035916|142891837|OTHER|||||||0.065|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."||||0.065
71687669|NCT03035916|142891837|OTHER|||||||0.168|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.168
71687670|NCT03035916|142891837|OTHER|||||||0.739|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.739
71920679|NCT03812224|143362761|SUPERIORITY||LS Mean Difference|-1.47|||<|0.001||95.0|-2.24|-0.71|||Generalized Linear Mixed Model|||Analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of migraine type (episodic migraine or chronic migraine) and prior migraine preventive treatment status (ever used or never used), and baseline value as covariates and assumes a first-order auto regression covariance structure.||-0.71|-2.24|<0.001
71687671|NCT03035916|142891837|OTHER|||||||0.079|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."||||0.079
71687672|NCT03035916|142891838|OTHER|||||||0.056|||||||t-test, 2 sided|||||||0.056
71687673|NCT03035916|142891838|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71687674|NCT03035916|142891838|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71920680|NCT02643420|143362818|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% confidence interval (CI) of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|-0.148|||<|0.0001|TWO_SIDED|95.0|-0.266|-0.031|||t-statistics|The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.||||-0.031|-0.266|<0.0001
71920681|NCT02643420|143362819|SUPERIORITY||Mean Difference (Final Values)|-0.25||||0.685|TWO_SIDED|95.0|-1.43|0.94|||Negative binomial regression|||||0.94|-1.43|0.685
71880784|NCT02819635|143280726|SUPERIORITY||Adjusted risk difference (%)|13.6|||<|0.001|TWO_SIDED|95.0|6.6|20.6||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||20.6|6.6|<0.001
71880785|NCT02819635|143280727|SUPERIORITY||Adjusted risk difference (%)|38.7|||<|0.001|TWO_SIDED|95.0|28.9|48.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||48.5|28.9|<0.001
71880786|NCT02819635|143280727|SUPERIORITY||Adjusted risk difference (%)|45.1|||<|0.001|TWO_SIDED|95.0|35.5|54.8||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||54.8|35.5|<0.001
71880787|NCT02819635|143280728|SUPERIORITY||Adjusted risk difference (%)|24.3|||<|0.001|TWO_SIDED|95.0|14.2|34.5||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||34.5|14.2|<0.001
71880788|NCT02819635|143280728|SUPERIORITY||Adjusted risk difference (%)|33.7|||<|0.001|TWO_SIDED|95.0|23.6|43.9||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|Cochran-Mantel-Haenszel|Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||43.9|23.6|<0.001
71880789|NCT02819635|143280729|SUPERIORITY||LS Mean Difference|5.1|||<|0.001|TWO_SIDED|95.0|2.67|7.52||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 15 mg - Placebo|Substudy 3: Upadacitinib 15 mg vs Placebo||7.52|2.67|<0.001
71880790|NCT02819635|143280729|SUPERIORITY||LS Mean Difference|5.9|||<|0.001|TWO_SIDED|95.0|3.44|8.27||The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).|ANCOVA|Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)|Difference = Upadacitinib 30 mg - Placebo|Substudy 3: Upadacitinib 30 mg vs Placebo||8.27|3.44|<0.001
71880791|NCT04416555|143280743|SUPERIORITY|||||||0.391|||||||Mixed Models Analysis|||||||0.391
71920682|NCT02643420|143362820|SUPERIORITY||Median Difference (Final Values)|1.2||||0.155|TWO_SIDED|95.0|0.93|1.56|||Asymptotic normality assumption|P-value was obtained based upon asymptotic normality assumption on the log10 transformed data.||||1.56|0.93|0.155
71920683|NCT02643420|143362821|SUPERIORITY||Percent Difference|1.1||||0.435|TWO_SIDED|95.0|-8.6|10.8|||Fisher Exact|||||10.8|-8.6|0.435
71920684|NCT02643420|143362822|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.042|||<|0.0001|TWO_SIDED|95.0|-0.032|0.116|||t-statistics|||DSN in Cycle 2||0.116|-0.032|<0.0001
71920685|NCT02643420|143362822|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.026|||<|0.0001|TWO_SIDED|95.0|-0.032|0.085|||t-statistics|||DSN in Cycle 3||0.085|-0.032|<0.0001
71920686|NCT02643420|143362822|NON_INFERIORITY|The margin of non-inferiority to be used in the study is 0.62 day. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was \<0.62 days.|Mean Difference (Final Values)|0.027|||<|0.0001|TWO_SIDED|95.0|-0.036|0.089|||t-statistics|||DSN in Cycle 4||0.089|-0.036|<0.0001
71687675|NCT03035916|142891839|OTHER|||||||0.056||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.056
71687676|NCT03035916|142891839|OTHER|||||||0.009||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.009
71687677|NCT03035916|142891839|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
71687678|NCT03035916|142891839|OTHER|||||||0.198|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.198
71687679|NCT03035916|142891839|OTHER|||||||0.047|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.047
71687680|NCT03035916|142891839|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.002
71687681|NCT03035916|142891839|OTHER|||||||0.102|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.102
71687682|NCT03035916|142891839|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.005
71687683|NCT03035916|142891839|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
71687684|NCT03035916|142891839|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687685|NCT03035916|142891839|OTHER|||||||0.023|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.023
71687686|NCT03035916|142891839|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71880792|NCT04416555|143280744|SUPERIORITY|||||||0.608|||||||Regression, Linear|||||||0.608
71687687|NCT03035916|142891839|OTHER|||||||0.425|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.425
71687688|NCT03035916|142891839|OTHER|||||||0.124|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.124
71687689|NCT03035916|142891839|OTHER|||||||0.052|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.052
71687690|NCT03035916|142891840|OTHER|||||||0.176||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.176
71687691|NCT03035916|142891840|OTHER|||||||0.001||||||p\<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."||||0.001
71687692|NCT03035916|142891840|OTHER|||||||0.228|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.228
71687693|NCT03035916|142891840|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687694|NCT03035916|142891840|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."||||0.001
71687695|NCT03035916|142891840|OTHER|||||||0.057|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.057
71687696|NCT03035916|142891840|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
71687697|NCT03035916|142891840|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."||||0.001
71687698|NCT03035916|142891840|OTHER|||||||0.004|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.004
71687699|NCT03035916|142891840|OTHER|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.005
71687700|NCT03035916|142891840|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."||||0.001
71687701|NCT03035916|142891840|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
71687702|NCT03035916|142891840|OTHER|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.002
71880793|NCT04416555|143280745|SUPERIORITY|||||||0.768|||||||Mixed Models Analysis|||||||0.768
71880794|NCT04416555|143280746|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
71880795|NCT04416555|143280747|SUPERIORITY|||||||0.191|||||||Wilcoxon (Mann-Whitney)|||||||0.191
71880796|NCT01118273|143280753|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANCOVA|||||||0.54
71880797|NCT01118273|143280754|SUPERIORITY_OR_OTHER|||||||0.31|||||||ANCOVA|||||||0.31
71880798|NCT01118273|143280755|SUPERIORITY_OR_OTHER|||||||0.45|||||||Log Rank|||||||0.45
71880799|NCT01118273|143280756|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71880800|NCT01118273|143280757|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||||||0.05
71880801|NCT01118273|143280758|SUPERIORITY_OR_OTHER|||||||0.019|||||||ANCOVA|||||||0.019
71687703|NCT03035916|142891840|OTHER|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."||||0.001
71687704|NCT03035916|142891841|OTHER|||||||0.585|||||||t-test, 2 sided|||||||0.585
71687705|NCT03035916|142891841|OTHER|||||||0.071|||||||t-test, 2 sided|||||||0.071
71687706|NCT03035916|142891841|OTHER|||||||0.13|||||||t-test, 2 sided|||||||0.13
71687707|NCT03035916|142891842|OTHER|||||||0.644|||||||t-test, 2 sided|||||||0.644
71687708|NCT03035916|142891842|OTHER|||||||0.045|||||||t-test, 2 sided|||||||0.045
71687709|NCT03035916|142891842|OTHER|||||||0.031|||||||t-test, 2 sided|||||||0.031
71687710|NCT03035916|142891843|OTHER|||||||0.421|||||||t-test, 2 sided|||||||0.421
71687711|NCT03035916|142891843|OTHER|||||||0.046|||||||t-test, 2 sided|||||||0.046
71687712|NCT03035916|142891843|OTHER|||||||0.007|||||||t-test, 2 sided|||||||0.007
71920687|NCT02643420|143362823|SUPERIORITY||Percent Difference|0.3||||1|TWO_SIDED|95.0|-9.5|10.0|||Fisher Exact|||||10.0|-9.5|1.000
71920688|NCT02643420|143362824|SUPERIORITY||Percent Difference|0.0||||1|TWO_SIDED|95.0|-9.7|9.8|||Fisher Exact|||FN in Cycle 2||9.8|-9.7|1.000
71920689|NCT02643420|143362824|SUPERIORITY||Percent Difference|1.6||||0.201|TWO_SIDED|95.0|-8.2|11.3|||Fisher Exact|||FN in Cycle 3||11.3|-8.2|0.201
71920690|NCT02643420|143362824|SUPERIORITY||Percent Difference|1.0||||0.232|TWO_SIDED|95.0|-8.7|10.8|||Fisher Exact|||FN in Cycle 4||10.8|-8.7|0.232
71920691|NCT04138758|143362843|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.85|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of a first COPD exacerbation.||0.85|0.68|
71920692|NCT04138758|143362844|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.97|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of first hospitalization for community-acquired pneumonia.||0.97|0.57|
71920693|NCT04138758|143362845|OTHER|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.|Hazard Ratio (HR)|0.23|||||TWO_SIDED|95.0|0.19|0.27|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|||0.27|0.19|
71920694|NCT04138758|143362846|OTHER||Hazard Ratio (HR)|0.22|||||TWO_SIDED|95.0|0.19|0.26|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of escalation.||0.26|0.19|
71920695|NCT04138758|143362847|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.42|0.51|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.51|0.42|
71920696|NCT04138758|143362848|OTHER||Hazard Ratio (HR)|0.45|||||TWO_SIDED|95.0|0.41|0.49|||||Hazard Ratio lower than 1 favors Tiotropium + Olodaterol.|Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid therapy combination on the risk of any element of a composite outcome including exacerbation, hospitalization for pneumonia, or escalation.||0.49|0.41|
71920697|NCT00125138|143362908|SUPERIORITY_OR_OTHER||Difference of LS Mean|0.1||||0.5177|TWO_SIDED|95.0|-6.3|6.6||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||6.6|-6.3|0.5177
71920698|NCT00125138|143362908|SUPERIORITY_OR_OTHER||Difference of LS mean|-2.9||||0.1519|TWO_SIDED|95.0|-8.5|2.7||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||2.7|-8.5|0.1519
71920699|NCT00125138|143362908|SUPERIORITY_OR_OTHER||Difference of LS mean|0.3||||0.5406|TWO_SIDED|95.0|-5.2|5.8||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.||5.8|-5.2|0.5406
71920700|NCT00125138|143362909|SUPERIORITY_OR_OTHER|||||||0.9212||95.0||||Overall p-value using a one-way ANCOVA.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||Only subjects with both a baseline and a post-baseline value are included.||||0.9212
71920701|NCT00041119|143362910|SUPERIORITY|If the 5-year DFS for 4 cycles is 84.7% then a decrease of 23% in hazard rate for 6 cycles corresponds to an increase in 5-year DFS to 88%. Assuming a 2-sided significance level of 0.05, there is 90.9% power to detect such an increase at the final analysis conducted 6.4 years after study activation.|Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.84|1.28||||||The null hypothesis is that the hazards of both 6 and 4 cycle regimens are equal. The alternative hypothesis is a hazard ratio of 0.77, corresponding to a decrease of 23% in hazard due to longer duration of chemotherapy.||1.28|0.84|
71687713|NCT03035916|142891844|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.910
71687714|NCT03035916|142891844|OTHER|||||||0.864|||||||t-test, 2 sided|||||||0.864
71687715|NCT03035916|142891844|OTHER|||||||0.785|||||||t-test, 2 sided|||||||0.785
71687716|NCT03035916|142891845|OTHER|||||||0.972|||||||t-test, 2 sided|||||||0.972
71687717|NCT03035916|142891845|OTHER|||||||0.987|||||||t-test, 2 sided|||||||0.987
71920702|NCT00041119|143362911|EQUIVALENCE|For T to be considered equivalent to the standard CA, a confidence interval of the hazard ratio of T to CA should be wholly to the left of 1.3, corresponding to a 30% increase in hazard rate. If the 5-year DFS for CA is 88% then an increase of 30% in hazard rate for T corresponds to 5-year DFS of 84.7%. The null hypothesis is that the hazard ratio of T to CA exceeds 1.3. The alternative hypothesis is that the two hazard rates are equivalent.|Hazard Ratio (HR)|1.26|||||ONE_SIDED|95.0||1.48||||||||1.48||
71920703|NCT00041119|143362912|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years. We assume the 5-year DFS of CA therapy is 88% and 84.7% for T. These assumptions are based upon results of SWOG 8897.|Hazard Ratio (HR)|1.27|||||ONE_SIDED|95.0||1.56||||||||1.56||
71687718|NCT03035916|142891845|OTHER|||||||0.518|||||||t-test, 2 sided|||||||0.518
71687719|NCT02636439|142891859|SUPERIORITY||Mean Difference (Final Values)|44.0||||0.21|TWO_SIDED|95.0|-25.0|112.0|||ANCOVA|adjusted for baseline value, age, and sex.||||112|-25|0.21
71687720|NCT02636439|142891860|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.0|0.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.8|-1.0|0.86
71687721|NCT02636439|142891861|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.77|TWO_SIDED|95.0|-2.8|3.8|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.8|-2.8|0.77
71687722|NCT02636439|142891862|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.85|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.2|-0.3|0.85
71687723|NCT02636439|142891863|SUPERIORITY||Mean Difference (Final Values)|6.4||||0.053|TWO_SIDED|95.0|-0.1|12.9|||ANCOVA|Adjusted for baseline value, age, and sex.||||12.9|-0.1|0.053
71687724|NCT02636439|142891864|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.043|TWO_SIDED|95.0|0.0|0.13|||ANCOVA|Adjusted for baseline value, age, and sex.||||0.13|0.00|0.043
71687725|NCT02636439|142891865|SUPERIORITY||Mean Difference (Final Values)|-5.0||||0.07|TWO_SIDED|95.0|-10.0|0.0|||ANCOVA|Adjusted for baseline value, age, and sex.||||0|-10|0.07
71687726|NCT02636439|142891866|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.79|TWO_SIDED|95.0|-4.4|3.3|||ANCOVA|Adjusted for baseline value, age, and sex.||||3.3|-4.4|0.79
71687727|NCT00762034|142891910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.94896|TWO_SIDED|95.0|0.86|1.16|||Log Rank|||||1.16|0.86|0.94896
71687728|NCT00762034|142891911|SUPERIORITY_OR_OTHER|||||||0.72997||95.0|||||Fisher Exact|||||||0.72997
71687729|NCT00762034|142891912|SUPERIORITY_OR_OTHER|||||||0.20892|||||||Fisher Exact|||||||0.20892
71687730|NCT00762034|142891913|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.01206|TWO_SIDED|95.0|0.71|0.96|||Log Rank|||||0.96|0.71|0.01206
71687731|NCT00762034|142891914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.006|TWO_SIDED|95.0|0.67|0.94|||Log Rank|||||0.94|0.67|0.006
71687732|NCT00762034|142891919|SUPERIORITY_OR_OTHER|||||||0.667||95.0||||Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.667
71687733|NCT00762034|142891920|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.815
71687734|NCT00762034|142891920|SUPERIORITY_OR_OTHER|||||||0.978||95.0||||p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||0.978
71687735|NCT00762034|142891921|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71880802|NCT01118273|143280759|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.018
71880803|NCT01118273|143280760|SUPERIORITY_OR_OTHER|||||||0.03|||||||Cochran-Mantel-Haenszel|||||||0.03
71880804|NCT01118273|143280761|SUPERIORITY_OR_OTHER|||||||0.76|||||||Cochran-Mantel-Haenszel|||||||0.76
71880805|NCT01118273|143280762|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANCOVA|||||||0.015
71880806|NCT01118273|143280763|SUPERIORITY_OR_OTHER|||||||0.04|||||||Cochran-Mantel-Haenszel|||||||0.04
71880807|NCT01118273|143280764|SUPERIORITY_OR_OTHER|||||||0.95|||||||ANCOVA|||||||0.95
71880808|NCT01118273|143280765|SUPERIORITY_OR_OTHER|||||||0.05|||||||Cochran-Mantel-Haenszel|||||||0.05
71880809|NCT01118273|143280767|SUPERIORITY_OR_OTHER|||||||0.42|||||||ANCOVA|||||||0.42
71880810|NCT01118273|143280768|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
71880811|NCT01118273|143280769|SUPERIORITY_OR_OTHER|||||||0.35|||||||ANCOVA|||||||0.35
71880812|NCT01118273|143280770|SUPERIORITY_OR_OTHER|||||||0.72|||||||ANCOVA|||||||0.72
71880813|NCT01118273|143280771|SUPERIORITY_OR_OTHER|||||||0.001|||||||Log Rank|||||||0.001
71880814|NCT01118273|143280773|SUPERIORITY_OR_OTHER|||||||0.35|||||||Cochran-Mantel-Haenszel|||||||0.35
71880815|NCT01118273|143280775|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||||||0.53
71880816|NCT01118273|143280776|SUPERIORITY_OR_OTHER|||||||0.55|||||||ANCOVA|||||||0.55
71880817|NCT01118273|143280777|SUPERIORITY_OR_OTHER|||||||0.59|||||||ANCOVA|||||||0.59
71880818|NCT01118273|143280778|SUPERIORITY_OR_OTHER|||||||0.25|||||||ANCOVA|||||||0.25
71880819|NCT01923285|143280786|NON_INFERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001||||||The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|Chi-squared|||"The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.~If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025."||||<0.0001
71880820|NCT01923285|143280786|SUPERIORITY|The non-inferiority margin, which is pre-specified at 10%. If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025|||||=|0.0004|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||=0.0004
71882940|NCT01157078|143284944|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.9||0.435|TWO_SIDED|95.0|-2.47|1.07|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||1.07|-2.47|0.435
71880821|NCT01923285|143280787|OTHER|Comparison of the mean difference. Difference in intensities is calculated as the supine paresthesia intensity minus the upright paresthesia intensity.|Mean Difference (Net)|1.9|||<|0.0001|TWO_SIDED|95.0|1.0|2.8|||Wilcoxon (Mann-Whitney)||Difference in paresthesia intensities is calculated as the supine paresthesia score minus the upright paresthesia score for each subject.|"Secondary endpoint compared the mean differences in upright and supine paresthesia scores between the Axium and Control groups at three months post INS implant. This endpoint was evaluated at a two-sided significance level of 0.05.~The primary hypothesis tested was: H0: μ0- μ1≤0 vs. H1: μ0- μ1\>0 where μ0 is the mean difference in paresthesia intensities in the Control group and μ1 is the mean difference in the Axium group."||2.8|1.0|<0.0001
71880822|NCT01923285|143280788|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||<|0.0001|||||||Chi-squared|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||<0.0001
71880823|NCT01923285|143280788|SUPERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.|||||=|0.0047|||||||Chi-squared|||||||=0.0047
71880824|NCT01923285|143280789|NON_INFERIORITY|If non-inferiority is achieved at a one-sided alpha of 0.05, a one-sided superiority test is performed at the significance level of 0.025.||||||0.0003|||||||Non-inferiority|||The primary hypothesis tested was: H0: p1 ≤ p0 - δ vs. H1: p1\> p0 - δ, where p0 is the success rate in the Control group, p1 is the success rate in the Axium group, and δ is the non-inferiority margin, which is pre-specified at 10%.||||0.0003
71880825|NCT03201458|143280809|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.027|TWO_SIDED|90.0|0.35|0.93||One-sided test|Log Rank|||||0.93|0.35|0.027
71880826|NCT03201458|143280810|SUPERIORITY||Odds Ratio (OR)|2.3||||0.22|TWO_SIDED||||||Fisher Exact|||||||0.22
71880827|NCT03201458|143280812|SUPERIORITY|||||||0.41||||||One-sided test|Log Rank|||||||0.410
71880828|NCT04707157|143280820|SUPERIORITY||Posterior Mean Difference|-1.56|||||TWO_SIDED|95.0|-2.76|-0.38|||||Posterior mean difference with 95% credible interval is reported.|||-0.38|-2.76|
71880829|NCT04707157|143280821|SUPERIORITY||Posterior Mean Difference|-1.03|||||TWO_SIDED|95.0|-2.14|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-2.14|
71880830|NCT04707157|143280822|SUPERIORITY||Posterior Mean Difference|-0.91|||||TWO_SIDED|95.0|-1.56|-0.25|||||Posterior mean difference with 95% credible interval is reported.|||-0.25|-1.56|
71880831|NCT04707157|143280823|SUPERIORITY||Posterior Mean Difference|-1.99|||||TWO_SIDED|95.0|-3.22|-0.77|||||Posterior mean difference with 95% credible interval is reported.|||-0.77|-3.22|
71880832|NCT04707157|143280824|SUPERIORITY||Posterior Mean Difference|-19.12|||||TWO_SIDED|95.0|-31.22|-6.97|||||Posterior mean difference with 95% credible interval is reported.|||-6.97|-31.22|
71880833|NCT04707157|143280825|SUPERIORITY||Posterior Mean Difference|-0.11|||||TWO_SIDED|95.0|-0.86|0.64|||||Posterior mean difference with 95% credible interval is reported.|||0.64|-0.86|
71880834|NCT04707157|143280826|SUPERIORITY||Posterior Mean Difference|-269.92|||||TWO_SIDED|95.0|-624.98|86.24|||||Posterior mean difference with 95% credible interval is reported.|||86.24|-624.98|
71880835|NCT04707157|143280827|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.22|0.29|||||Posterior mean difference with 95% credible interval is reported.|||0.29|-0.22|
71920704|NCT00041119|143362916|NON_INFERIORITY_OR_EQUIVALENCE|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years.|Hazard Ratio (HR)|1.12|||||TWO_SIDED|95.0|0.84|1.49||||||||1.49|.84|
71922480|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-3.4||||0.499|TWO_SIDED|95.0|-12.0|5.2|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.2|-12.0|0.499
71880836|NCT00804570|143280828|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3||||0.12|TWO_SIDED|95.0|-9.72|1.13|||Mixed Models Analysis|||||1.13|-9.72|0.120
71880837|NCT00804570|143280829|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.013|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||||-0.15|-1.27|0.013
71880838|NCT00804570|143280830|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.37||||0.051|TWO_SIDED|95.0|-0.02|10.77|||Mixed Models Analysis|||||10.77|-0.02|0.051
71880839|NCT00804570|143280831|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||0.249|TWO_SIDED|95.0|-1.07|0.28|||Mixed Models Analysis|||||0.28|-1.07|0.249
71880840|NCT00804570|143280832|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.199|TWO_SIDED|95.0|-1.12|0.23|||Mixed Models Analysis|||||0.23|-1.12|0.199
71880841|NCT00804570|143280833|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.68||||0.318|TWO_SIDED|95.0|-2.03|0.66|||Mixed Models Analysis|||||0.66|-2.03|0.318
71880842|NCT00804570|143280834|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.034|TWO_SIDED|95.0|-5.8|-0.22|||Mixed Models Analysis|||||-0.22|-5.80|0.034
71880843|NCT00804570|143280835|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.9||||0.001|TWO_SIDED|95.0|0.85|0.96|||Mixed Models Analysis|||||0.96|0.85|0.001
71880844|NCT00804570|143280836|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.96||||0.103|TWO_SIDED|95.0|0.91|1.01|||Mixed Models Analysis|||||1.01|0.91|0.103
71880845|NCT00804570|143280837|SUPERIORITY_OR_OTHER_LEGACY||GMR over Baseline relative to placebo|0.94||||0.012|TWO_SIDED|95.0|0.89|0.99|||Mixed Models Analysis|||||0.99|0.89|0.012
71880846|NCT00804570|143280838|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32||||0.392|TWO_SIDED|95.0|-1.05|0.41|||Mixed Models Analysis|||||0.41|-1.05|0.392
71880847|NCT00804570|143280839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.44||||0.185|TWO_SIDED|95.0|-1.1|0.21|||Mixed Models Analysis|||||0.21|-1.10|0.185
71880848|NCT00804570|143280840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.25||||0.142|TWO_SIDED|95.0|-0.42|2.92|||ANCOVA|||||2.92|-0.42|0.142
71880849|NCT00804570|143280841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.69|TWO_SIDED|95.0|-1.01|0.04||P-value is for desire to stop drinking at this time.|ANCOVA|||||0.04|-1.01|0.69
71687736|NCT00762034|142891921|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis|||||||<0.001
71920705|NCT01258738|143362923|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.64||||0.0062|TWO_SIDED|95.0|5.36|27.92||P-value \<0.05 was required to declare statistical significance.|Cochran-Mantel-Haenszel|||"The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo.~The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only."||27.92|5.36|0.0062
71920706|NCT01258738|143362924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.46||||0.0059|TWO_SIDED|95.0|3.69|19.24|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.24|3.69|0.0059
71920707|NCT01258738|143362924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.19||||0.3786|TWO_SIDED|95.0|-4.98|15.35|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4"||15.35|-4.98|0.3786
71920708|NCT01258738|143362924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0304|TWO_SIDED|95.0|1.79|23.87|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.87|1.79|0.0304
71920709|NCT01258738|143362924|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.52||||0.0023|TWO_SIDED|95.0|7.29|29.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.75|7.29|0.0023
71920710|NCT01258738|143362925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.44||||0.0189|TWO_SIDED|95.0|3.2|25.68|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||25.68|3.20|0.0189
71920711|NCT01258738|143362925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29||||0.0983|TWO_SIDED|95.0|-2.17|22.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||22.75|-2.17|0.0983
71920712|NCT01258738|143362925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.61||||0.0867|TWO_SIDED|95.0|-2.63|23.84|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||23.84|-2.63|0.0867
71920713|NCT01258738|143362925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.27||||0.0195|TWO_SIDED|95.0|3.1|29.43|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||29.43|3.10|0.0195
71920714|NCT01258738|143362926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.63|||<|0.0001|TWO_SIDED|95.0|11.85|33.41|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||33.41|11.85|<0.0001
71920715|NCT01258738|143362926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.83||||0.0021|TWO_SIDED|95.0|5.09|20.57|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||20.57|5.09|0.0021
71920716|NCT01258738|143362926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.89||||0.002|TWO_SIDED|95.0|5.18|24.6|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||24.60|5.18|0.0020
71920717|NCT01258738|143362926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.79|||<|0.0001|TWO_SIDED|95.0|10.92|32.67|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||32.67|10.92|<0.0001
71920718|NCT01258738|143362927|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920719|NCT01258738|143362927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|||<|0.001|TWO_SIDED|95.0|-0.74|-0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.34|-0.74|<0.001
71920720|NCT01258738|143362927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.81|-0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.41|-0.81|<0.001
71920721|NCT01258738|143362927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-0.85|<0.001
71687737|NCT00762034|142891935|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||<|0.001|TWO_SIDED|95.0|0.338|0.681||p-value was not adjusted for multiple comparisons.|Regression, Cox|||||0.681|0.338|<0.001
71880850|NCT00804570|143280841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.545|TWO_SIDED|95.0|-0.85|0.45||P-value is for expectation of success in quitting alcohol.|ANCOVA|||||0.45|-0.85|0.545
71880851|NCT00804570|143280841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.48||||0.19|TWO_SIDED|95.0|-1.2|0.24||P-value is for difficulty to quit and remain abstinent.|ANCOVA|||||0.24|-1.20|0.190
71687738|NCT00762034|142891936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.927||||0.673|TWO_SIDED|95.0|0.654|1.316||p-value is for TS Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.316|0.654|0.673
71687739|NCT00762034|142891936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.521||||0.287|TWO_SIDED|95.0|0.157|1.729||p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.729|0.157|0.287
71687740|NCT00762034|142891936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.759||||0.2|TWO_SIDED|95.0|0.498|1.157||p-value is for TS Nucleus Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.157|0.498|0.2
71687741|NCT00762034|142891936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.915|TWO_SIDED|95.0|0.54|1.738||p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.738|0.540|0.915
71687742|NCT00762034|142891937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97||||0.891|TWO_SIDED|95.0|0.622|1.511||p-value for FR-α Cytoplasm Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.511|0.622|0.891
71687743|NCT00762034|142891937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.592||||0.06|TWO_SIDED|95.0|0.342|1.023||p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.023|0.342|0.060
71687744|NCT00762034|142891937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.905|TWO_SIDED|95.0|0.49|1.88||p-value for FR-α Membrane Positive (H score \> 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.880|0.490|0.905
71687745|NCT00762034|142891937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.859||||0.455|TWO_SIDED|95.0|0.575|1.281||p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox|||||1.281|0.575|0.455
71687746|NCT04656301|142891944|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|degrees of freedom = 1.92||||||<0.001
71687747|NCT02187029|142891980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-52.55|||||TWO_SIDED|90.0|-56.32|-48.78|||Bayesian ANCOVA|||||-48.780|-56.320|
71687748|NCT02187029|142891980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.31|||||TWO_SIDED|90.0|-71.31|-61.54|||Bayesian ANCOVA|||||-61.540|-71.310|
71687749|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||||90.0|-0.55|-0.06|||Mixed Models Analysis|||Day 1, Hour 1||-0.06|-0.55|
71880852|NCT00804570|143280841|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04||||0.856|TWO_SIDED|95.0|-0.49|0.4||P-value is for goal related to alcohol use.|ANCOVA|||||0.40|-0.49|0.856
71920722|NCT01258738|143362928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84||||0.0209|TWO_SIDED|95.0|2.58|23.09|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||23.09|2.58|0.0209
71880853|NCT00804570|143280842|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.77||||0.297|TWO_SIDED|95.0|-0.68|2.22|||Mixed Models Analysis|||||2.22|-0.68|0.297
71880854|NCT00804570|143280843|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46||||0.633|TWO_SIDED|95.0|-1.44|2.36|||Mixed Models Analysis|||||2.36|-1.44|0.633
71920723|NCT01258738|143362928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.65||||0.0179|TWO_SIDED|95.0|1.82|15.48|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.~Week 2"||15.48|1.82|0.0179
71687750|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-0.95|-0.28|||Mixed Models Analysis|||Day 1, Hour 2||-0.28|-0.95|
71687751|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|90.0|-1.52|-1.16|||Mixed Models Analysis|||Day 1, Hour 4||-1.16|-1.52|
71687752|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.86|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-2.38|-1.33|||Mixed Models Analysis|||Day 1, Hour 8||-1.33|-2.38|
71687753|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.83|STANDARD_ERROR_OF_MEAN|0.19|||TWO_SIDED|90.0|-2.18|-1.48|||Mixed Models Analysis|||Day 1, Hour 12||-1.48|-2.18|
71687754|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.2|||TWO_SIDED|90.0|-2.11|-1.37|||Mixed Models Analysis|||Day 1, Hour 24||-1.37|-2.11|
71687755|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.48|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-2.89|-2.06|||Mixed Models Analysis|||Day 3||-2.06|-2.89|
71687756|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.75|STANDARD_ERROR_OF_MEAN|0.3|||TWO_SIDED|90.0|-3.29|-2.2|||Mixed Models Analysis|||Day 7, pre-dose||-2.20|-3.29|
71687757|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.8|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-3.39|-2.21|||Mixed Models Analysis|||Day 7, Hour 1||-2.21|-3.39|
71687758|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.06|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-3.72|-2.41|||Mixed Models Analysis|||Day 7, Hour 2||-2.41|-3.72|
71687759|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-4.03|-2.77|||Mixed Models Analysis|||Day7, Hour 4||-2.77|-4.03|
71687760|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.3|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.82|-2.79|||Mixed Models Analysis|||Day 7, Hour 8||-2.79|-3.82|
71687761|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.2|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-3.72|-2.68|||Mixed Models Analysis|||Day 7, Hour 12||-2.68|-3.72|
71880855|NCT00804570|143280846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.77||||0.409|TWO_SIDED|95.0|-2.62|1.07||P-value is for supine systolic blood pressure.|Mixed Models Analysis|||||1.07|-2.62|0.409
71880856|NCT00804570|143280846|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.45||||0.452|TWO_SIDED|95.0|-1.63|0.73||P-value is for supine diastolic blood pressure.|Mixed Models Analysis|||||0.73|-1.63|0.452
71880857|NCT00804570|143280847|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53||||0.456|TWO_SIDED|95.0|-1.93|0.87|||Mixed Models Analysis|||||0.87|-1.93|0.456
71880858|NCT00804570|143280848|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.08||||0.081|TWO_SIDED|95.0|-4.41|0.26|||Mixed Models Analysis|||||0.26|-4.41|0.081
71920724|NCT01258738|143362928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81||||0.0611|TWO_SIDED|95.0|-0.03|13.65|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||13.65|-0.03|0.0611
71920725|NCT01258738|143362928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.73||||0.0141|TWO_SIDED|95.0|3.14|22.32|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||22.32|3.14|0.0141
71920726|NCT01258738|143362928|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920727|NCT01258738|143362929|SUPERIORITY_OR_OTHER|||||||0.0022|TWO_SIDED||||||Log Rank|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||||0.0022
71920728|NCT01258738|143362930|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920729|NCT01258738|143362930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0156|TWO_SIDED|95.0|-1.26|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.13|-1.26|0.0156
71880859|NCT00804570|143280849|SUPERIORITY_OR_OTHER_LEGACY|||||||0.122||95.0|||||Fisher Exact|||||||0.122
71880860|NCT00804570|143280850|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Fisher Exact|||||||0.002
71920730|NCT01258738|143362930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0111|TWO_SIDED|95.0|-1.06|-0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.14|-1.06|0.0111
71920731|NCT01258738|143362930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.0936|TWO_SIDED|95.0|-0.91|0.07|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.07|-0.91|0.0936
71920732|NCT01258738|143362930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2678|TWO_SIDED|95.0|-0.81|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.23|-0.81|0.2678
71920733|NCT01258738|143362931|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920734|NCT01258738|143362931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0102|TWO_SIDED|95.0|-1.4|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.40|0.0102
71920735|NCT01258738|143362931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0007|TWO_SIDED|95.0|-1.44|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.39|-1.44|0.0007
71920736|NCT01258738|143362931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0057|TWO_SIDED|95.0|-1.35|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.23|-1.35|0.0057
71920737|NCT01258738|143362931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0077|TWO_SIDED|95.0|-1.44|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.44|0.0077
71920738|NCT01258738|143362932|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920739|NCT01258738|143362932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93||||0.0091|TWO_SIDED|95.0|-1.62|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.23|-1.62|0.0091
71920740|NCT01258738|143362932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.0097|TWO_SIDED|95.0|-1.38|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.19|-1.38|0.0097
71920741|NCT01258738|143362932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.82||||0.0101|TWO_SIDED|95.0|-1.45|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.45|0.0101
71880861|NCT00804570|143280851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.69||||0.235|TWO_SIDED|95.0|-1.82|0.45||P-value is for orthostatic systolic blood pressure.|Mixed Models Analysis|||||0.45|-1.82|0.235
71880862|NCT00804570|143280851|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31||||0.4|TWO_SIDED|95.0|-1.05|0.42||P-value is for orthostatic diastolic blood pressure.|Mixed Models Analysis|||||0.42|-1.05|0.400
71880863|NCT00804570|143280852|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.74||||0.077|TWO_SIDED|95.0|-0.08|1.57|||Mixed Models Analysis|||||1.57|-0.08|0.077
71920742|NCT01258738|143362932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0031|TWO_SIDED|95.0|-1.61|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.33|-1.61|0.0031
71687762|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.81|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-3.3|-2.32|||Mixed Models Analysis|||Day 7, Hour 24||-2.32|-3.30|
71880864|NCT00804570|143280854|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|||<|0.001|TWO_SIDED|95.0|0.24|0.9|||Mixed Models Analysis|||||0.90|0.24|<0.001
71880865|NCT00290342|143280855|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to diphteria||1.79|-1.85|
71880866|NCT00290342|143280855|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups'difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to tetanus||1.79|-1.85|
71880867|NCT00290342|143280856|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||TWO_SIDED|95.0|-1.85|1.82||||||Immune response non-inferiority - Anti-Polio 1||1.82|-1.85|
71880868|NCT00290342|143280856|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.49|||||TWO_SIDED|95.0|-1.36|2.71||||||Immune response non-inferiority - Anti-Polio 2||2.71|-1.36|
71880869|NCT00290342|143280856|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|-0.01|||||TWO_SIDED|95.0|-2.28|2.24||||||Immune response non-inferiority - Anti-Polio 3||2.24|-2.28|
71880870|NCT00290342|143280857|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|1.44|||||TWO_SIDED|95.0|-0.46|4.13||||||Immune response non-inferiority - Anti-PT||4.13|-0.46|
71880871|NCT00290342|143280857|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.45|||||TWO_SIDED|95.0|-1.88|2.95||||||Immune response non-inferiority - Anti-FHA||2.95|-1.88|
71880872|NCT00290342|143280857|NON_INFERIORITY_OR_EQUIVALENCE|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups' difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.47|||||TWO_SIDED|95.0|-1.4|2.64||||||Immune response non-inferiority - Anti-PRN||2.64|-1.4|
71880873|NCT01056510|143280868|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||The first-line subpopulation became the focus of the primary statistical analysis following the protocol amendment dated 21-May-2012.||||0.002
71880874|NCT01056510|143280869|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||< 0.001
71880875|NCT01056510|143280870|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||||||0.009
71880876|NCT01056510|143280871|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 3 cycles||||0.900
71880877|NCT01056510|143280871|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 6 cycles||||0.563
71880878|NCT01056510|143280871|SUPERIORITY_OR_OTHER|||||||0.304|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||At the EOT visit||||0.304
71880879|NCT01056510|143280874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.525||||0.003|TWO_SIDED|95.0|0.341|0.809|||Log Rank|||Unstratified analysis||0.809|0.341|0.003
71687763|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.56|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-5.19|-3.92|||Mixed Models Analysis|||Day 11||-3.92|-5.19|
71880880|NCT01056510|143280874|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.523||||0.003|TWO_SIDED|95.0|0.339|0.806|||Log Rank|||Stratified analysis: by baseline Binet stage||0.806|0.339|0.003
71920743|NCT01258738|143362933|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920744|NCT01258738|143362933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.0064|TWO_SIDED|95.0|-1.49|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.25|-1.49|0.0064
71920745|NCT01258738|143362933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0407|TWO_SIDED|95.0|-1.12|-0.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.02|-1.12|0.0407
71687764|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-4.75|-3.88|||Mixed Models Analysis|||Day 14, pre-dose||-3.88|-4.75|
71687765|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.55|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.02|-4.08|||Mixed Models Analysis|||Day 14, Hour 1||-4.08|-5.02|
71880881|NCT01056510|143280876|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Log Rank|||||||0.029
71880882|NCT01056510|143280878|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Log Rank|||||||0.006
71880883|NCT01056510|143280880|SUPERIORITY_OR_OTHER|||||||0.037|TWO_SIDED||||||Log Rank|||||||0.037
71880884|NCT01056510|143280882|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED||||||Log Rank|||||||0.007
71880885|NCT01056510|143280884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.994||||0.986|TWO_SIDED|95.0|0.517|1.911||Unstratified analysis|Log Rank|||||1.911|0.517|0.986
71880886|NCT01056510|143280884|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.975||||0.939|TWO_SIDED|95.0|0.505|1.88|||Log Rank|||Stratified analysis: by baseline Binet stage||1.880|0.505|0.939
71880887|NCT01056510|143280885|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||||||< 0.001
71880888|NCT00243386|143280888|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6016||95.0|||||t-test, 2 sided|||A t-test was used to compare the means of the transformed data. The null-hypothesis tested was H0: X'A(PK-driven prophylaxis) - X'B (standard prophylaxis) = 0 (i.e., no difference for treatment under the 2 prophylactic regimens. X' = (ABR+0.5)\^(1/2)||||0.6016
71880889|NCT00243386|143280889|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-Test|||||||<0.0001
71880890|NCT00243386|143280890|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
71880891|NCT00243386|143280891|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test|||||||<0.0001
71880892|NCT00243386|143280892|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4924||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.4924
71880893|NCT00243386|143280913|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1467||95.0|||||Wilcoxon-Rank Sum (Mann-Whitney)|||||||0.1467
71880894|NCT00243386|143280914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0007
71880895|NCT00243386|143280915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0||||Due to multiple hypotheses testing results, adjusted alpha values are set to α\*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values \< α\*|Wilcoxon signed-rank test|||||||0.0002
71880896|NCT00243386|143280916|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon Signed-Rank Test|||||||<0.0001
71880897|NCT02285998|143280917|NON_INFERIORITY_OR_EQUIVALENCE|The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.|Relative Vaccine Efficacy (rVE)|30.0|||||TWO_SIDED|95.0|10.0|47.0||||||The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was \> -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be \> +9%.||47|10|
71880898|NCT02662036|143280965|SUPERIORITY|||||||0.76|||||||Mann Whitney U Test|||Statistical analysis #1 is for intraoperative opioid use||||0.76
71880899|NCT02662036|143280965|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||Statistical analysis #2 is for postoperative acute care unit opioid use||||0.38
71880900|NCT02662036|143280965|SUPERIORITY|||||||0.69|||||||Mann Whitney U Test|||Statistical analysis #3 is for postoperative floor opioid use||||0.69
71880901|NCT02662036|143280965|SUPERIORITY|||||||0.98|||||||Mann Whitney U Test|||Statistical analysis #4 is for total opioid use||||0.98
71880902|NCT02662036|143280966|SUPERIORITY|||||||0.28|||||||Mann Whitney U Test|||Statistical analysis #1 is for postoperative acute care unit antiemetic use||||0.28
71880903|NCT02662036|143280966|SUPERIORITY|||||||0.62|||||||Mann Whitney U Test|||Statistical analysis #2 is for floor antiemetic use||||0.62
71880904|NCT02662036|143280966|SUPERIORITY|||||||0.5|||||||Mann Whitney U Test|||Statistical analysis #3 is for total antiemetic use||||0.50
71880905|NCT02662036|143280967|SUPERIORITY|||||||0.2|||||||Mann Whitney U Test|||||||0.20
71880906|NCT02662036|143280968|SUPERIORITY|||||||0.64|||||||Mann Whitney U Test|||||||0.64
71880907|NCT02662036|143280969|SUPERIORITY|||||||0.38|||||||Mann Whitney U Test|||||||0.38
71880908|NCT04995055|143280977|SUPERIORITY||Least-square Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|2.81|||TWO_SIDED|95.0|-21.2|-9.5|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-9.5|-21.2|
71880909|NCT04995055|143280978|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
71880910|NCT04995055|143280979|SUPERIORITY||Least-square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|0.66|||TWO_SIDED|95.0|-4.9|-2.1|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-2.1|-4.9|
71880911|NCT04995055|143280980|SUPERIORITY||Least-square Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.05|||TWO_SIDED|95.0|0.2|0.4|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||0.4|0.2|
71880912|NCT04995055|143280982|SUPERIORITY||Least-square Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|95.0|-4.4|-1.9|||Linear Mixed Model|Kenward and Roger method was used for denominator degrees of freedom.|Least-square Mean difference was calculated as senofilcon A (C3)- senofilcon A|||-1.9|-4.4|
71880913|NCT03418129|143280984|SUPERIORITY||Slope|0.2331|STANDARD_ERROR_OF_MEAN|0.2176||0.2852|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.2852
71880914|NCT03418129|143280984|SUPERIORITY||Slope|0.03057|STANDARD_ERROR_OF_MEAN|0.2132||0.8861|TWO_SIDED||||||ANCOVA||Multilevel modeling was used to model outcome at baseline and 3-month follow-up. Resulting slopes capture change in outcome from baseline to follow-up, with relaxation set as the comparison.|||||0.8861
71880915|NCT03418129|143280985|SUPERIORITY||Slope|-0.03844|STANDARD_ERROR_OF_MEAN|0.09424||0.6842|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.6842
71880916|NCT03418129|143280985|SUPERIORITY||Slope|-0.1432|STANDARD_ERROR_OF_MEAN|0.09427||0.132|TWO_SIDED||||||ANOVA||Multilevel modeling was used to model outcomes at two time points (3-month follow-up and baseline) and across three treatment groups (Mindfulness, Neurofeedback, and Relaxation).|||||0.132
71880917|NCT03418129|143280986|SUPERIORITY||Slope|0.1911|STANDARD_ERROR_OF_MEAN|0.2551||0.4542|TWO_SIDED||||||ANCOVA|||||||0.4542
71880918|NCT03418129|143280986|SUPERIORITY||Slope|-0.3761|STANDARD_ERROR_OF_MEAN|0.2454||0.1261|TWO_SIDED||||||ANCOVA|||||||0.1261
71880919|NCT02186847|143281021|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.7563|TWO_SIDED|95.0|0.77|1.73|||Log Rank|One-sided significance level = 0.10|Reference level = Chemoradiation|The study was powered to detect an improvement of the 1-year progression-free survival rate from 50% (no metformin) to 65% (metformin) or equivalently a hazard ratio (HR) of 0.622, at one-sided type 1 error of 0.1 and 85% power with at least 102 progression-free survival events.||1.73|0.77|0.7563
71880920|NCT02186847|143281022|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.891|TWO_SIDED|95.0|0.64|1.68|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.68|0.64|0.8910
71880921|NCT02186847|143281023|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-side significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
71880922|NCT02186847|143281024|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.4075|TWO_SIDED|95.0|0.71|2.34|||Log Rank|Two-sided significance level = 0.05|Reference level = Chemoradiation|||2.34|0.71|0.4075
71880923|NCT02186847|143281025|SUPERIORITY||Odds Ratio (OR)|0.92||||0.6266|TWO_SIDED|95.0|0.47|1.8|||Chi-squared|Two-sided significance level = 0.05|Reference level = Chemoradiation|||1.80|0.47|0.6266
71882941|NCT01157078|143284945|SUPERIORITY_OR_OTHER||LS mean|-0.7|STANDARD_ERROR_OF_MEAN|0.97||0.501|TWO_SIDED|95.0|-2.56|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.||1.25|-2.56|0.501
71882942|NCT01157078|143284946|SUPERIORITY_OR_OTHER||LS mean|-0.62|STANDARD_ERROR_OF_MEAN|0.771||0.424|TWO_SIDED|95.0|-2.134|0.901||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.901|-2.134|0.424
71882943|NCT01157078|143284947|SUPERIORITY_OR_OTHER||LS mean|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.214|TWO_SIDED|95.0|-0.96|0.22||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.22|-0.96|0.214
71882944|NCT01157078|143284948|SUPERIORITY_OR_OTHER||LS mean|0.0|STANDARD_ERROR_OF_MEAN|0.29||0.931|TWO_SIDED|95.0|-0.59|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.54|-0.59|0.931
71882945|NCT01157078|143284949|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.26||0.755|TWO_SIDED|95.0|-0.6|0.44|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.||0.44|-0.60|0.755
71882946|NCT01157078|143284950|SUPERIORITY_OR_OTHER||LS mean|0.82|STANDARD_ERROR_OF_MEAN|1.789||0.646|TWO_SIDED|95.0|-2.699|4.346|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.||4.346|-2.699|0.646
71880924|NCT03670953|143281055|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|0.53|STANDARD_ERROR_OF_MEAN|0.226||0.0194|TWO_SIDED|95.0|0.09|0.97||"LSM, SE, CI and p-value from a MMRM with CFB in Good on time as outcome, baseline Good on time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||0.97|0.09|0.0194
71880925|NCT03670953|143281056|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.214||0.0252|TWO_SIDED|95.0|-0.9|-0.06||"LSM, SE, CI and p-value from a MMRM with CFB in Off time as outcome, baseline Off time as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction."|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||-0.06|-0.90|0.0252
71880926|NCT03670953|143281057|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Percent difference|10.9||||0.0015|TWO_SIDED|95.0|3.5|18.3||"P-value from the Cochran-Mantel-Haenszel test stratified by pooled center comparing the percentage of Much or Very Much Improved participants between the treatment groups."|Cochran-Mantel-Haenszel|||||18.3|3.5|0.0015
71920746|NCT01258738|143362933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64||||0.0349|TWO_SIDED|95.0|-1.24|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.24|0.0349
71920747|NCT01258738|143362933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.0021|TWO_SIDED|95.0|-1.65|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.37|-1.65|0.0021
71920748|NCT01258738|143362934|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920749|NCT01258738|143362934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0164|TWO_SIDED|95.0|-1.04|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.04|0.0164
71920750|NCT01258738|143362934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0095|TWO_SIDED|95.0|-0.95|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-0.95|0.0095
71920751|NCT01258738|143362934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0127|TWO_SIDED|95.0|-0.99|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.12|-0.99|0.0127
71920752|NCT01258738|143362934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0166|TWO_SIDED|95.0|-0.99|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-0.99|0.0166
71920753|NCT01258738|143362935|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920754|NCT01258738|143362935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.0029|TWO_SIDED|95.0|-1.28|-0.27|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.27|-1.28|0.0029
71920755|NCT01258738|143362935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0147|TWO_SIDED|95.0|-1.21|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.13|-1.21|0.0147
71920756|NCT01258738|143362935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0056|TWO_SIDED|95.0|-1.28|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.22|-1.28|0.0056
71920757|NCT01258738|143362935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.001|TWO_SIDED|95.0|-1.52|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.39|-1.52|0.0010
71920758|NCT01258738|143362936|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920759|NCT01258738|143362936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0173|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.12|-1.19|0.0173
71920760|NCT01258738|143362936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1618|TWO_SIDED|95.0|-0.97|0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.16|-0.97|0.1618
71920761|NCT01258738|143362936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.0153|TWO_SIDED|95.0|-1.25|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.13|-1.25|0.0153
71920762|NCT01258738|143362936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0866|TWO_SIDED|95.0|-1.05|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.07|-1.05|0.0866
71920763|NCT01258738|143362937|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920764|NCT01258738|143362937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.1413|TWO_SIDED|95.0|-0.95|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.95|0.1413
71920765|NCT01258738|143362937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0284|TWO_SIDED|95.0|-1.14|-0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.06|-1.14|0.0284
71920766|NCT01258738|143362937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.0659|TWO_SIDED|95.0|-1.07|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.03|-1.07|0.0659
71880927|NCT03670953|143281058|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.89||0.9587|TWO_SIDED|95.0|-1.8|1.7||LSM, SE, CI and p-value from a MMRM with CFB in MDS-UPDRS Part III Score as outcome, baseline MDS-UPDRS Part III Score as a covariate, treatment and visit as fixed effects, pooled center as random effect and a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||1.7|-1.8|0.9587
71880928|NCT03670953|143281059|SUPERIORITY|2-sided at a significance level of alpha = 0.05|Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.11||0.9668|TWO_SIDED|95.0|-2.2|2.1||LSM, SE, CI \& p-value from MMRM with CFB in MDS-UPDRS Part II \& III Scores as outcome, baseline MDS-UPDRS Part II and III Scores as a covariate, treatment and visit as fixed effects, pooled center as random effect \& a treatment-by-visit interaction.|MMRM|The degree-of-freedom of the denominator is estimated using the Kenward-Roger method. Unstructured covariance structure is assumed.||||2.1|-2.2|0.9668
71880929|NCT04342871|143281067|OTHER|Pre-post comparison from baseline to 2-weeks post-intervention||||||0.2|||||||t-test, 2 sided|||||||0.2
71880930|NCT00666458|143281071|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.055|||TWO_SIDED|95.0|-0.01|0.2||||||||0.20|-0.01|
71880931|NCT00666458|143281072|SUPERIORITY_OR_OTHER||Difference in Percent|-2.8|||||TWO_SIDED|95.0|-9.0|3.5||||||||3.5|-9.0|
71880932|NCT00666458|143281073|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.42|STANDARD_ERROR_OF_MEAN|2.064|||TWO_SIDED|95.0|1.37|9.47||||||||9.47|1.37|
71880933|NCT00666458|143281074|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.115|||TWO_SIDED|95.0|0.08|0.53||||||||0.53|0.08|
71880934|NCT04353284|143281108|SUPERIORITY||Mean Difference (Net)|0.74||||0.06|TWO_SIDED|95.0|-0.03|1.51|||Mixed Models Analysis|||This analysis compares the change from baseline between treatment arms.||1.51|-0.03|0.06
71880935|NCT04353284|143281109|SUPERIORITY||Mean Difference (Net)|0.06||||0.87|TWO_SIDED|95.0|-0.7|0.83|||Mixed Models Analysis|||||0.83|-0.70|0.87
71880936|NCT04353284|143281110|SUPERIORITY||Mean Difference (Net)|0.23||||0.69|TWO_SIDED|95.0|-0.94|1.4|||Mixed Models Analysis|||||1.4|-0.94|0.69
71687766|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.97|STANDARD_ERROR_OF_MEAN|0.27|||TWO_SIDED|90.0|-5.47|-4.47|||Mixed Models Analysis|||Day 14, Hour 2||-4.47|-5.47|
71687767|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.43|STANDARD_ERROR_OF_MEAN|0.22|||TWO_SIDED|90.0|-5.83|-5.02|||Mixed Models Analysis|||Day 14, Hour 4||-5.02|-5.83|
71687768|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.57|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-6.08|-5.05|||Mixed Models Analysis|||Day 14, Hour 8||-5.05|-6.08|
71687769|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.34|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|90.0|-5.86|-4.82|||Mixed Models Analysis|||Day 14, Hour 12||-4.82|-5.86|
71687770|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.65|STANDARD_ERROR_OF_MEAN|0.25|||TWO_SIDED|90.0|-5.12|-4.18|||Mixed Models Analysis|||Day 14, Hour 24||-4.18|-5.12|
71687771|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.09|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.97|0.79|||Mixed Models Analysis|||Follow-up, Day 25-29||0.79|-2.97|
71880937|NCT04353284|143281111|SUPERIORITY||Odds Ratio (OR)|1.3||||0.71|TWO_SIDED|95.0|0.33|5.09|||GEE|||Nasopharyngeal Swab Samples analyzed.||5.09|0.33|0.71
71687772|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.17|||TWO_SIDED|90.0|-0.92|-0.32|||Mixed Models Analysis|||Day 1, Hour 1||-0.32|-0.92|
71687773|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-1.61|-0.75|||Mixed Models Analysis|||Day 1, Hour 2||-0.75|-1.61|
71687774|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.91|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|90.0|-3.14|-2.69|||Mixed Models Analysis|||Day 1, Hour 4||-2.69|-3.14|
71687775|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-4.36|-3.03|||Mixed Models Analysis|||Day 1, Hour 8||-3.03|-4.36|
71687776|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.84|STANDARD_ERROR_OF_MEAN|0.24|||TWO_SIDED|90.0|-4.28|-3.4|||Mixed Models Analysis|||Day 1, Hour 12||-3.40|-4.28|
71687777|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.47|STANDARD_ERROR_OF_MEAN|0.26||||90.0|-3.94|-3.0|||Mixed Models Analysis|||Day 1, Hour 24||-3.00|-3.94|
71880938|NCT04353284|143281111|SUPERIORITY||Odds Ratio (OR)|0.4||||0.17|TWO_SIDED|95.0|0.11|1.47|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||1.47|0.11|0.17
71880939|NCT04353284|143281112|SUPERIORITY||Odds Ratio (OR)|3.05||||0.03|TWO_SIDED|95.0|1.12|8.26|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||8.26|1.12|0.03
71880940|NCT04353284|143281112|SUPERIORITY||Odds Ratio (OR)|1.23||||0.68|TWO_SIDED|95.0|0.47|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.47|0.68
71687778|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.76|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-5.29|-4.23|||Mixed Models Analysis|||Day 3||-4.23|-5.29|
71687779|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.81|STANDARD_ERROR_OF_MEAN|0.45|||TWO_SIDED|90.0|-6.62|-5.0|||Mixed Models Analysis|||Day 7, pre-dose||-5.00|-6.62|
71687780|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.84|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|90.0|-6.72|-4.95|||Mixed Models Analysis|||Day 7, Hour 1||-4.95|-6.72|
71687781|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.18|STANDARD_ERROR_OF_MEAN|0.55|||TWO_SIDED|90.0|-7.17|-5.19|||Mixed Models Analysis|||Day 7, Hour 2||-5.19|-7.17|
71687782|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.51|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-7.46|-5.55|||Mixed Models Analysis|||Day 7, Hour 4||-5.55|-7.46|
71687783|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-7.07|-5.51|||Mixed Models Analysis|||Day 7, Hour 8||-5.51|-7.07|
71687784|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.24|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-7.03|-5.44|||Mixed Models Analysis|||Day 7, Hour 12||-5.44|-7.03|
71687785|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.75|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-6.5|-4.99|||Mixed Models Analysis|||Day 7, Hour 24||-4.99|-6.50|
71687786|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.62|STANDARD_ERROR_OF_MEAN|0.53|||TWO_SIDED|90.0|-6.59|-4.65|||Mixed Models Analysis|||Day 11||-4.65|-6.59|
71687787|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.76|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-6.42|-5.1|||Mixed Models Analysis|||Day 14, pre-dose||-5.10|-6.42|
71687788|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.96|STANDARD_ERROR_OF_MEAN|0.39|||TWO_SIDED|90.0|-6.67|-5.24|||Mixed Models Analysis|||Day 14, Hour 1||-5.24|-6.67|
71687789|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.14|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-6.9|-5.38|||Mixed Models Analysis|||Day 14, Hour 2||-5.38|-6.90|
71687790|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.42|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-7.03|-5.81|||Mixed Models Analysis|||Day 14, Hour 4||-5.81|-7.03|
71687791|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.64|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.41|-5.87|||Mixed Models Analysis|||Day 14, Hour 8||-5.87|-7.41|
71687792|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|0.42|||TWO_SIDED|90.0|-7.18|-5.63|||Mixed Models Analysis|||Day 14, Hour 12||-5.63|-7.18|
71687793|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.77|STANDARD_ERROR_OF_MEAN|0.38|||TWO_SIDED|90.0|-6.47|-5.07|||Mixed Models Analysis|||Day 14, Hour 24||-5.07|-6.47|
71687794|NCT02187029|142891985|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.66|STANDARD_ERROR_OF_MEAN|1.26|||TWO_SIDED|90.0|-4.96|-0.35|||Mixed Models Analysis|||Follow-up, Day 25-29||-0.35|-4.96|
71687795|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0355|STANDARD_ERROR_OF_MEAN|0.0423|||TWO_SIDED|90.0|-0.1103|0.0394|||Mixed Models Analysis|||Day 1, Hour 1||0.0394|-0.1103|
71687796|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0152|STANDARD_ERROR_OF_MEAN|0.0631|||TWO_SIDED|90.0|-0.1269|0.0966|||Mixed Models Analysis|||Day 1, Hour 2||0.0966|-0.1269|
71687797|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0331|STANDARD_ERROR_OF_MEAN|0.0422|||TWO_SIDED|90.0|-0.1078|0.0417|||Mixed Models Analysis|||Day 1, Hour 4||0.0417|-0.1078|
71687798|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0035|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.075|0.082|||Mixed Models Analysis|||Day 1, Hour 8||0.0820|-0.0750|
71687799|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0502|STANDARD_ERROR_OF_MEAN|0.0367|||TWO_SIDED|90.0|-0.1153|0.0149|||Mixed Models Analysis|||Day 1, Hour 12||0.0149|-0.1153|
71687800|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.008|STANDARD_ERROR_OF_MEAN|0.0553|||TWO_SIDED|90.0|-0.1058|0.0899|||Mixed Models Analysis|||Day 1, Hour 24||0.0899|-0.1058|
71687801|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0539|STANDARD_ERROR_OF_MEAN|0.0561|||TWO_SIDED|90.0|-0.1538|0.046|||Mixed Models Analysis|||Day 7, pre-dose||0.0460|-0.1538|
71687802|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0109|STANDARD_ERROR_OF_MEAN|0.0506|||TWO_SIDED|90.0|-0.0793|0.101|||Mixed Models Analysis|||Day 7, Hour 1||0.1010|-0.0793|
71687803|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.033|STANDARD_ERROR_OF_MEAN|0.0496|||TWO_SIDED|90.0|-0.0554|0.1213|||Mixed Models Analysis|||Day 7, Hour 2||0.1213|-0.0554|
71687804|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0086|STANDARD_ERROR_OF_MEAN|0.0459|||TWO_SIDED|90.0|-0.0733|0.0905|||Mixed Models Analysis|||Day 7, Hour 4||0.0905|-0.0733|
71687805|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0244|STANDARD_ERROR_OF_MEAN|0.0349|||TWO_SIDED|90.0|-0.0865|0.0378|||Mixed Models Analysis|||Day 7, Hour 8||0.0378|-0.0865|
71687806|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0526|STANDARD_ERROR_OF_MEAN|0.0251|||TWO_SIDED|90.0|-0.0973|-0.0079|||Mixed Models Analysis|||Day 7, Hour 12||-0.0079|-0.0973|
71687807|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0298|STANDARD_ERROR_OF_MEAN|0.0331|||TWO_SIDED|90.0|-0.0889|0.0292|||Mixed Models Analysis|||Day 7, Hour 24||0.0292|-0.0889|
71687808|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0167|STANDARD_ERROR_OF_MEAN|0.0268|||TWO_SIDED|90.0|-0.0649|0.0315|||Mixed Models Analysis|||Day 14, pre-dose||0.0315|-0.0649|
71687809|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0616|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|0.001|0.1222|||Mixed Models Analysis|||Day 14, Hour 1||0.1222|0.0010|
71687810|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1025|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.0104|0.1945|||Mixed Models Analysis|||Day 14, Hour 2||0.1945|0.0104|
71687811|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0062|STANDARD_ERROR_OF_MEAN|0.0495|||TWO_SIDED|90.0|-0.0827|0.0952|||Mixed Models Analysis|||Day 14, Hour 4||0.0952|-0.0827|
71880941|NCT04353284|143281113|SUPERIORITY||Odds Ratio (OR)|6.28||||0.1|TWO_SIDED|95.0|0.7|56.6|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||||56.60|0.70|0.10
71687812|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0124|STANDARD_ERROR_OF_MEAN|0.0443|||TWO_SIDED|90.0|-0.0672|0.0919|||Mixed Models Analysis|||Day 14, Hour 8||0.0919|-0.0672|
71687813|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0186|STANDARD_ERROR_OF_MEAN|0.0408|||TWO_SIDED|90.0|-0.0918|0.0547|||Mixed Models Analysis|||Day 14, Hour 12||0.0547|-0.0918|
71880942|NCT04353284|143281113|SUPERIORITY||Odds Ratio (OR)|0.9||||0.87|TWO_SIDED|95.0|0.25|3.23|||GEE|Within subject correlation is controlled by specifying a compound symmetry R-side structure in the model.||Saliva RT-PCR samples analyzed.||3.23|0.25|0.87
71880943|NCT04353284|143281114|SUPERIORITY||Mean Difference (Net)|-6.6||||0.02|TWO_SIDED|95.0|-12.1|-1.2|||Mixed Models Analysis|||||-1.2|-12.1|0.02
71880944|NCT04353284|143281115|SUPERIORITY||Mean Difference (Net)|-2.1||||0.48|TWO_SIDED|95.0|-7.9|3.7|||Mixed Models Analysis|||||3.7|-7.9|0.48
71880945|NCT04353284|143281116|SUPERIORITY||Mean Difference (Net)|1.0||||0.16|TWO_SIDED|95.0|-0.4|2.3|||Mixed Models Analysis|||||2.3|-0.4|0.16
71880946|NCT04353284|143281117|SUPERIORITY||Mean Difference (Net)|0.7||||0.34|TWO_SIDED|95.0|-0.7|2.1|||Mixed Models Analysis|||||2.1|-0.7|0.34
71880947|NCT00676676|143281133|SUPERIORITY_OR_OTHER|||||||0.002|||||||t-test, 2 sided|||Baseline versus 2-week||||0.002
71880948|NCT00676676|143281133|SUPERIORITY_OR_OTHER|||||||0.004|||||||t-test, 2 sided|||Baseline versus 8-week||||0.004
71880949|NCT03129321|143281134|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|4.24|||||TWO_SIDED|90.0|-5.05|13.54||||||||13.54|-5.05|
71880950|NCT03129321|143281135|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71880951|NCT03129321|143281135|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
71880952|NCT03129321|143281136|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|2.85|||||TWO_SIDED|90.0|-6.29|11.98||||||||11.98|-6.29|
71880953|NCT03129321|143281137|EQUIVALENCE|Equivalence margin: +/-20%|Difference in proportions|-0.02|||||TWO_SIDED|90.0|-8.29|8.26||||||||8.26|-8.29|
71880954|NCT03129321|143281138|SUPERIORITY|||||||0.002|||||||Cochran-Mantel-Haenszel|||||||0.0020
71880955|NCT03129321|143281138|SUPERIORITY|||||||0.0076|||||||Cochran-Mantel-Haenszel|||||||0.0076
71880956|NCT03129321|143281139|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71880957|NCT03129321|143281139|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71880958|NCT01148537|143281155|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.91|||<|0.001|TWO_SIDED|90.0|3.4|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||||8.4|3.4|< .001
71880959|NCT01148537|143281156|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.77|TWO_SIDED|90.0|-1.8|2.6|||ANCOVA||For the comparison of BTDS to placebo, the subjects randomized to moxifloxacin were excluded.|||2.6|-1.8|.770
71880960|NCT01148537|143281157|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|||<|0.001|TWO_SIDED|90.0|3.3|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||Day 13 analysis||8.4|3.3|< .001
71687814|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.0413|STANDARD_ERROR_OF_MEAN|0.0433|||TWO_SIDED|90.0|-0.1192|0.0365|||Mixed Models Analysis|||Day 14, Hour 24||0.0365|-0.1192|
71687815|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4011|STANDARD_ERROR_OF_MEAN|0.3916|||TWO_SIDED|90.0|-0.2968|1.099|||Mixed Models Analysis|||Follow-up, Day 25-29||1.0990|-0.2968|
71687816|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1175|STANDARD_ERROR_OF_MEAN|0.0537|||TWO_SIDED|90.0|0.0223|0.2127|||Mixed Models Analysis|||Day 1, Hour 1||0.2127|0.0223|
71880961|NCT01148537|143281158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.64|||<|0.001|TWO_SIDED|90.0|5.4|9.9|||ANCOVA|ANCOVA model with average baseline as a covariate, and with gender and treatment as main effects||||9.9|5.4|< .001
71880962|NCT01148537|143281159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.936|TWO_SIDED|90.0|-2.9|2.6|||ANCOVA|||Day 6 analysis||2.6|-2.9|.936
71880963|NCT01148537|143281159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.16|||<|0.001|TWO_SIDED|90.0|4.2|10.1|||ANCOVA|||Day 13 analysis||10.1|4.2|< .001
71880964|NCT01148537|143281160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|||<|0.001|TWO_SIDED|90.0|5.5|10.9|||ANCOVA|||Day 6 analysis||10.9|5.5|< .001
71880965|NCT01148537|143281160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.4|||<|0.001|TWO_SIDED|90.0|4.3|10.5|||ANCOVA|||Day 13 analysis||10.5|4.3|< .001
71880966|NCT01148537|143281161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.427|TWO_SIDED|90.0|-1.4|4.0|||ANCOVA|||Day 6 analysis||4.0|-1.4|.427
71880967|NCT01148537|143281161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.01||||0.001|TWO_SIDED|90.0|3.2|8.8|||ANCOVA|||Day 13 analysis||8.8|3.2|.001
71880968|NCT01148537|143281162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86|||<|0.001|TWO_SIDED|90.0|4.2|9.6|||ANCOVA|||Day 6 analysis||9.6|4.2|< .001
71880969|NCT01148537|143281162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.68||||0.006|TWO_SIDED|90.0|1.9|7.4|||ANCOVA|||Day 13 analysis||7.4|1.9|.006
71880970|NCT00393887|143281163|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Fisher Exact|||Two-sided Fisher's exact test||||0.11
71880971|NCT03503877|143281164|SUPERIORITY|||||||0.07|||||||Wilcoxon signed-rank testing|||||||0.07
71880972|NCT03503877|143281165|SUPERIORITY|||||||0.89|||||||Wilcoxon signed-rank testing|||||||0.89
71880973|NCT03503877|143281166|SUPERIORITY|||||||0.54||||||High mosaicism|Wilcoxon signed-rank testing|||||||0.54
71880974|NCT03503877|143281166|SUPERIORITY|||||||0.2||||||Low mosaicism|Wilcoxon signed-rank|||||||.20
71880975|NCT03503877|143281167|SUPERIORITY|||||||0.01||||||Time to Expanded Blastocyst|Wilcoxon signed-rank testing|||||||0.01
71880976|NCT00330382|143281178|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.11|||>|0.45|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area||||>0.45
71880977|NCT00330382|143281178|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.92|||>|0.88|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in protease activity with relative percent change in total lesion area||||> 0.88
71880978|NCT00330382|143281178|SUPERIORITY_OR_OTHER||Correlation Coefficient|0.07|||>|0.66|TWO_SIDED||||||Spearman Rank Correlation|||Correlation of percent change in serum Neu with relative percent change in total lesion area||||> 0.66
71880979|NCT02018822|143281214|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2552|||||||Chi-squared|||||||0.2552
71880980|NCT02018822|143281215|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2235|||||||Chi-squared|||||||0.2235
71880981|NCT02018822|143281216|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3891|||||||Chi-squared|||||||0.3891
71880982|NCT02018822|143281217|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
71880983|NCT02018822|143281218|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared|||||||0.3883
71880984|NCT02018822|143281219|NON_INFERIORITY|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2707|||||||Chi-squared|||||||0.2707
71880985|NCT01389752|143281231|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.65|||||TWO_SIDED|90.0|0.61|0.68||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.68|0.61|
71880986|NCT01389752|143281232|SUPERIORITY_OR_OTHER||Ratio of Geometric Least Squares Means|0.9|||||TWO_SIDED|90.0|0.83|0.98||The outcome was measured as a ratio of geometric means between the two treatments (LY2216684 in combination with activated charcoal/LY2216684 alone), and the 90% Confidence Interval for the ratio.|Mixed Models Analysis|||||0.98|0.83|
71880987|NCT01389752|143281233|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.55||||0.001|TWO_SIDED|90.0|-1.04|-0.5||The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).|Wilcoxon (Mann-Whitney)|||||-0.50|-1.04|0.0010
71880988|NCT04251910|143281246|SUPERIORITY|||||||0.0813|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0813
71880989|NCT04251910|143281246|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0011
71880990|NCT04251910|143281246|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0002
71880991|NCT04251910|143281248|SUPERIORITY|||||||0.9616|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.9616
71880992|NCT04251910|143281248|SUPERIORITY|||||||0.546|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.5460
71880993|NCT04251910|143281248|SUPERIORITY|||||||0.0961|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/s Part A-Placebo (2 hours)||||0.0961
71880994|NCT04251910|143281248|SUPERIORITY|||||||0.1359|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.1359
71880995|NCT04251910|143281248|SUPERIORITY|||||||0.1688|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.1688
71880996|NCT04251910|143281248|SUPERIORITY|||||||0.667|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.6670
71880997|NCT04251910|143281248|SUPERIORITY|||||||0.8695|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.8695
71880998|NCT04251910|143281248|SUPERIORITY|||||||0.5002|||||||Mixed effects model|||Part A-30 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.5002
71880999|NCT04251910|143281248|SUPERIORITY|||||||0.5631|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (30 minutes)||||0.5631
71881000|NCT04251910|143281248|SUPERIORITY|||||||0.0089|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (1 hour)||||0.0089
71881001|NCT04251910|143281248|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (2 hours)||||<.0001
71881002|NCT04251910|143281248|SUPERIORITY|||||||0.0011|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (4 hours)||||0.0011
71881003|NCT04251910|143281248|SUPERIORITY|||||||0.0008|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (8 hours)||||0.0008
71881004|NCT04251910|143281248|SUPERIORITY|||||||0.2847|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (24 hours)||||0.2847
71881005|NCT04251910|143281248|SUPERIORITY|||||||0.2616|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 3)||||0.2616
71687817|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3845|STANDARD_ERROR_OF_MEAN|0.0802|||TWO_SIDED|90.0|0.2424|0.5266|||Mixed Models Analysis|||Day 1, Hour 2||0.5266|0.2424|
71687818|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3812|STANDARD_ERROR_OF_MEAN|0.0536|||TWO_SIDED|90.0|0.2862|0.4762|||Mixed Models Analysis|||Day 1, Hour 4||0.4762|0.2862|
71687819|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2841|STANDARD_ERROR_OF_MEAN|0.0563|||TWO_SIDED|90.0|0.1843|0.3838|||Mixed Models Analysis|||Day 1, Hour 8||0.3838|0.1843|
71687820|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1462|STANDARD_ERROR_OF_MEAN|0.0467|||TWO_SIDED|90.0|0.0635|0.2289|||Mixed Models Analysis|||Day 1, Hour 12||0.2289|0.0635|
71687821|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.168|STANDARD_ERROR_OF_MEAN|0.0702|||TWO_SIDED|90.0|0.0436|0.2924|||Mixed Models Analysis|||Day 1, Hour 24||0.2924|0.0436|
71687822|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1303|STANDARD_ERROR_OF_MEAN|0.083|||TWO_SIDED|90.0|-0.0172|0.2778|||Mixed Models Analysis|||Day 7, pre-dose||0.2778|-0.0172|
71687823|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1953|STANDARD_ERROR_OF_MEAN|0.0747||||90.0|0.0625|0.3281|||Mixed Models Analysis|||Day 7, Hour 1||0.3281|0.0625|
71687824|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5409|STANDARD_ERROR_OF_MEAN|0.0729|||TWO_SIDED|90.0|0.411|0.6707|||Mixed Models Analysis|||Day 7, Hour 2||0.6707|0.4110|
71687825|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5235|STANDARD_ERROR_OF_MEAN|0.0675|||TWO_SIDED|90.0|0.4032|0.6438|||Mixed Models Analysis|||Day 7, Hour 4||0.6438|0.4032|
71687826|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3857|STANDARD_ERROR_OF_MEAN|0.0512|||TWO_SIDED|90.0|0.2944|0.4769|||Mixed Models Analysis|||Day 7, Hour 8||0.4769|0.2944|
71687827|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0216|STANDARD_ERROR_OF_MEAN|0.0368|||TWO_SIDED|90.0|-0.0439|0.0872|||Mixed Models Analysis|||Day 7, Hour 12||0.0872|-0.0439|
71687828|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1708|STANDARD_ERROR_OF_MEAN|0.0486|||TWO_SIDED|90.0|0.0841|0.2574|||Mixed Models Analysis|||Day 7, Hour 24||0.2574|0.0841|
71687829|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.166|STANDARD_ERROR_OF_MEAN|0.0377|||TWO_SIDED|90.0|0.0982|0.2338|||Mixed Models Analysis|||Day 14, pre-dose||0.2338|0.0982|
71687830|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3524|STANDARD_ERROR_OF_MEAN|0.0477|||TWO_SIDED|90.0|0.2667|0.438|||Mixed Models Analysis|||Day 14, Hour 1||0.4380|0.2667|
71687831|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5631|STANDARD_ERROR_OF_MEAN|0.0724|||TWO_SIDED|90.0|0.433|0.6932|||Mixed Models Analysis|||Day 14, Hour 2||0.6932|0.4330|
71687832|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5807|STANDARD_ERROR_OF_MEAN|0.07|||TWO_SIDED|90.0|0.4549|0.7065|||Mixed Models Analysis|||Day 14, Hour 4||0.7065|0.4549|
71687833|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2814|STANDARD_ERROR_OF_MEAN|0.0627|||TWO_SIDED|90.0|0.1688|0.394|||Mixed Models Analysis|||Day 14, Hour 8||0.3940|0.1688|
71687834|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1982|STANDARD_ERROR_OF_MEAN|0.0577|||TWO_SIDED|90.0|0.0945|0.3019|||Mixed Models Analysis|||Day 14, Hour 12||0.3019|0.0945|
71687835|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1465|STANDARD_ERROR_OF_MEAN|0.0615|||TWO_SIDED|90.0|0.0361|0.2569|||Mixed Models Analysis|||Day 14, Hour 24||0.2569|0.0361|
71687836|NCT02187029|142891991|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8565|STANDARD_ERROR_OF_MEAN|0.4796|||TWO_SIDED|90.0|0.0017|1.7112|||Mixed Models Analysis|||Follow-up, Day 25-29||1.7112|0.0017|
71687837|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.348|STANDARD_ERROR_OF_MEAN|0.209|||TWO_SIDED|90.0|-0.707|0.01|||Mixed Models Analysis|||Day 1, Hour 1||0.010|-0.707|
71687838|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.179|STANDARD_ERROR_OF_MEAN|0.205|||TWO_SIDED|90.0|-0.533|0.175|||Mixed Models Analysis|||Day 1, Hour 2||0.175|-0.533|
71687839|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.258|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.568|0.052|||Mixed Models Analysis|||Day 1, Hour 4||0.052|-0.568|
71687840|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.046|STANDARD_ERROR_OF_MEAN|0.201||||90.0|-0.39|0.298|||Mixed Models Analysis|||Day 1, Hour 8||0.298|-0.390|
71687841|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.284|STANDARD_ERROR_OF_MEAN|0.168||||90.0|-0.575|0.006|||Mixed Models Analysis|||Day 1, Hour 12||0.006|-0.575|
71687842|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.166|STANDARD_ERROR_OF_MEAN|0.235|||TWO_SIDED|90.0|-0.569|0.237|||Mixed Models Analysis|||Day 1, Hour 24||0.237|-0.569|
71687843|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.263|STANDARD_ERROR_OF_MEAN|0.23|||TWO_SIDED|90.0|-0.657|0.132|||Mixed Models Analysis|||Day 7, pre-dose||0.132|-0.657|
71687844|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.221|||TWO_SIDED|90.0|-0.46|0.299|||Mixed Models Analysis|||Day 7, Hour 1||0.299|-0.460|
71687845|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.082|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.392|0.228|||Mixed Models Analysis|||Day 7, Hour 2||0.228|-0.392|
71687846|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.083|STANDARD_ERROR_OF_MEAN|0.189|||TWO_SIDED|90.0|-0.408|0.242|||Mixed Models Analysis|||Day 7, Hour 4||0.242|-0.408|
71687847|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.207|STANDARD_ERROR_OF_MEAN|0.174|||TWO_SIDED|90.0|-0.508|0.095|||Mixed Models Analysis|||Day 7, Hour 8||0.095|-0.508|
71687848|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.451|0.191|||Mixed Models Analysis|||Day 7, Hour 12||0.191|-0.451|
71687849|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.186|||TWO_SIDED|90.0|-0.445|0.196|||Mixed Models Analysis|||Day 7, Hour 24||0.196|-0.445|
71687850|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.188|STANDARD_ERROR_OF_MEAN|0.162|||TWO_SIDED|90.0|-0.472|0.097|||Mixed Models Analysis|||Day 14, pre-dose||0.097|-0.472|
71687851|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.152|STANDARD_ERROR_OF_MEAN|0.161|||TWO_SIDED|90.0|-0.434|0.13|||Mixed Models Analysis|||Day 14, Hour 1||0.130|-0.434|
71687852|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.231|STANDARD_ERROR_OF_MEAN|0.155|||TWO_SIDED|90.0|-0.504|0.043|||Mixed Models Analysis|||Day 14, Hour 2||0.043|-0.504|
71687853|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.405|STANDARD_ERROR_OF_MEAN|0.184|||TWO_SIDED|90.0|-0.722|-0.088|||Mixed Models Analysis|||Day 14, Hour 4||-0.088|-0.722|
71687854|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.249|STANDARD_ERROR_OF_MEAN|0.18|||TWO_SIDED|90.0|-0.56|0.062|||Mixed Models Analysis|||Day 14, Hour 8||0.062|-0.560|
71687855|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.163|STANDARD_ERROR_OF_MEAN|0.176|||TWO_SIDED|90.0|-0.467|0.141|||Mixed Models Analysis|||Day 14, Hour 12||0.141|-0.467|
71687856|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.317|STANDARD_ERROR_OF_MEAN|0.183|||TWO_SIDED|90.0|-0.633|-0.002|||Mixed Models Analysis|||Day 14, Hour 24||-0.002|-0.633|
71687857|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.094|STANDARD_ERROR_OF_MEAN|0.339|||TWO_SIDED|90.0|-0.683|0.496|||Mixed Models Analysis|||Follow-up, Day 25-29||0.496|-0.683|
71687858|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.266|||TWO_SIDED|90.0|-0.406|0.505|||Mixed Models Analysis|||Day 1, Hour 1||0.505|-0.406|
71687859|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.257|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.193|0.707|||Mixed Models Analysis|||Day 1, Hour 2||0.707|-0.193|
71687860|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.091|STANDARD_ERROR_OF_MEAN|0.229|||TWO_SIDED|90.0|-0.302|0.485|||Mixed Models Analysis|||Day 1, Hour 4||0.485|-0.302|
71687861|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.33|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.107|0.768|||Mixed Models Analysis|||Day 1, Hour 8||0.768|-0.107|
71687862|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.283|STANDARD_ERROR_OF_MEAN|0.214|||TWO_SIDED|90.0|-0.087|0.653|||Mixed Models Analysis|||Day 1, Hour 12||0.653|-0.087|
71687863|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.488|STANDARD_ERROR_OF_MEAN|0.299|||TWO_SIDED|90.0|-0.024|1.0|||Mixed Models Analysis|||Day 1, Hour 24||1.000|-0.024|
71687864|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.206|STANDARD_ERROR_OF_MEAN|0.327|||TWO_SIDED|90.0|-0.356|0.768|||Mixed Models Analysis|||Day 7, pre-dose||0.768|-0.356|
71687865|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.123|STANDARD_ERROR_OF_MEAN|0.31|||TWO_SIDED|90.0|-0.41|0.656|||Mixed Models Analysis|||Day 7, Hour 1||0.656|-0.410|
71687866|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.396|STANDARD_ERROR_OF_MEAN|0.246|||TWO_SIDED|90.0|-0.025|0.818|||Mixed Models Analysis|||Day 7, Hour 2||0.818|-0.025|
71687867|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.077|STANDARD_ERROR_OF_MEAN|0.26|||TWO_SIDED|90.0|-0.523|0.368|||Mixed Models Analysis|||Day 7, Hour 4||0.368|-0.523|
71687868|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.254|STANDARD_ERROR_OF_MEAN|0.237|||TWO_SIDED|90.0|-0.154|0.661|||Mixed Models Analysis|||Day 7, Hour 8||0.661|-0.154|
71687869|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.125|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|-0.564|0.315|||Mixed Models Analysis|||Day 7, Hour 12||0.315|-0.564|
71687870|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.458|STANDARD_ERROR_OF_MEAN|0.256|||TWO_SIDED|90.0|0.019|0.897|||Mixed Models Analysis|||Day 7, Hour 24||0.897|0.019|
71687871|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.418|STANDARD_ERROR_OF_MEAN|0.215|||TWO_SIDED|90.0|0.043|0.792|||Mixed Models Analysis|||Day 14, pre-dose||0.792|0.043|
71687872|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.521|STANDARD_ERROR_OF_MEAN|0.213|||TWO_SIDED|90.0|0.15|0.893|||Mixed Models Analysis|||Day 14, Hour 1||0.893|0.150|
71687873|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.53|STANDARD_ERROR_OF_MEAN|0.204|||TWO_SIDED|90.0|0.172|0.888|||Mixed Models Analysis|||Day 14, Hour 2||0.888|0.172|
71687874|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.357|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.069|0.782|||Mixed Models Analysis|||Day 14, Hour 4||0.782|-0.069|
71687875|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.088|STANDARD_ERROR_OF_MEAN|0.242|||TWO_SIDED|90.0|-0.328|0.503|||Mixed Models Analysis|||Day 14, Hour 8||0.503|-0.328|
71687876|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.406|STANDARD_ERROR_OF_MEAN|0.236|||TWO_SIDED|90.0|0.0|0.812|||Mixed Models Analysis|||Day 14, Hour 12||0.812|0.000|
71687877|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|0.377|STANDARD_ERROR_OF_MEAN|0.247|||TWO_SIDED|90.0|-0.047|0.802|||Mixed Models Analysis|||Day 14, Hour 24||0.802|-0.047|
71687878|NCT02187029|142891992|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.223|STANDARD_ERROR_OF_MEAN|0.418|||TWO_SIDED|90.0|-0.949|0.502|||Mixed Models Analysis|||Follow-up, Day 25-29||0.502|-0.949|
71687879|NCT02187029|142891993|SUPERIORITY_OR_OTHER||LS Mean Difference|316.89|STANDARD_ERROR_OF_MEAN|166.57|||TWO_SIDED|90.0|21.91|611.88|||Mixed Models Analysis|||Day 1||611.88|21.91|
71687880|NCT02187029|142891993|SUPERIORITY_OR_OTHER||LS Mean Difference|61.97|STANDARD_ERROR_OF_MEAN|88.27|||TWO_SIDED|90.0|-94.87|218.82|||Mixed Models Analysis|||Day 7||218.82|-94.87|
71687881|NCT02187029|142891993|SUPERIORITY_OR_OTHER||LS Mean Difference|107.96|STANDARD_ERROR_OF_MEAN|100.38|||TWO_SIDED|90.0|-71.2|287.11|||Mixed Models Analysis|||Day 14||287.11|-71.20|
71687882|NCT02187029|142891993|SUPERIORITY_OR_OTHER||LS Mean Difference|433.21|STANDARD_ERROR_OF_MEAN|211.71|||TWO_SIDED|90.0|58.3|808.13|||Mixed Models Analysis|||Day 1||808.13|58.30|
71687883|NCT02187029|142891993|SUPERIORITY_OR_OTHER||LS Mean Difference|13.2|STANDARD_ERROR_OF_MEAN|125.47|||TWO_SIDED|90.0|-208.07|234.47|||Mixed Models Analysis|||Day 7||234.47|-208.07|
71687884|NCT02187029|142891993|SUPERIORITY_OR_OTHER||LS Mean Difference|-29.83|STANDARD_ERROR_OF_MEAN|142.95|||TWO_SIDED|90.0|-285.26|225.6|||Mixed Models Analysis|||Day 14||225.60|-285.26|
71687885|NCT02187029|142891994|SUPERIORITY_OR_OTHER||LS Mean Difference|3.44|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|0.71|6.17|||Mixed Models Analysis|||Day 1||6.17|0.71|
71687886|NCT02187029|142891994|SUPERIORITY_OR_OTHER||LS Mean Difference|3.67|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|1.97|5.37|||Mixed Models Analysis|||Day 7||5.37|1.97|
71687887|NCT02187029|142891994|SUPERIORITY_OR_OTHER||LS Mean Difference|8.1|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|6.24|9.96|||Mixed Models Analysis|||Day 14||9.96|6.24|
71687888|NCT02187029|142891994|SUPERIORITY_OR_OTHER||LS Mean Difference|13.12|STANDARD_ERROR_OF_MEAN|2.0|||TWO_SIDED|90.0|9.65|16.59|||Mixed Models Analysis|||Day 1||16.59|9.65|
71687889|NCT02187029|142891994|SUPERIORITY_OR_OTHER||LS Mean Difference|27.99|STANDARD_ERROR_OF_MEAN|1.4|||TWO_SIDED|90.0|25.49|30.49|||Mixed Models Analysis|||Day 7||30.49|25.49|
71687890|NCT02187029|142891994|SUPERIORITY_OR_OTHER||LS Mean Difference|28.77|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|26.14|31.41|||Mixed Models Analysis|||Day 14||31.41|26.14|
71687891|NCT02187029|142891995|SUPERIORITY_OR_OTHER||LS Mean Difference|0.9|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|-1.31|3.1|||Mixed Models Analysis|||Day 1||3.10|-1.31|
71687892|NCT02187029|142891995|SUPERIORITY_OR_OTHER||LS Mean Difference|2.91|STANDARD_ERROR_OF_MEAN|1.29|||TWO_SIDED|90.0|0.71|5.11|||Mixed Models Analysis|||Day 7||5.11|0.71|
71687893|NCT02187029|142891995|SUPERIORITY_OR_OTHER||LS Mean Difference|3.59|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|1.33|5.85|||Mixed Models Analysis|||Day 14||5.85|1.33|
71687894|NCT02187029|142891995|SUPERIORITY_OR_OTHER||LS Mean Difference|1.51|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-1.29|4.31|||Mixed Models Analysis|||Day 1||4.31|-1.29|
71881006|NCT04251910|143281248|SUPERIORITY|||||||0.1989|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 7)||||0.1989
71881007|NCT04251910|143281248|SUPERIORITY|||||||0.4585|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (30 minutes)||||0.4585
71881008|NCT04251910|143281248|SUPERIORITY|||||||0.0005|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (1 hour)||||0.0005
71687895|NCT02187029|142891995|SUPERIORITY_OR_OTHER||LS Mean Difference|7.73|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|4.57|10.89|||Mixed Models Analysis|||Day 7||10.89|4.57|
71687896|NCT02187029|142891995|SUPERIORITY_OR_OTHER||LS Mean Difference|9.07|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.91|12.23|||Mixed Models Analysis|||Day 14||12.23|5.91|
71687897|NCT04472494|142892037|SUPERIORITY||Odds Ratio (OR)|1.07||||0.9297|TWO_SIDED|95.0|0.26|4.49|||Cochran-Mantel-Haenszel Chi-Square test|||||4.49|0.26|0.9297
71881009|NCT04251910|143281248|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours)||||0.0004
71881010|NCT04251910|143281248|SUPERIORITY|||||||0.0025|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (4 hours)||||0.0025
71687898|NCT04472494|142892038|SUPERIORITY||Adjusted mean difference from Placebo|0.64||||0.74|TWO_SIDED|95.0|-0.55|1.82|||Cochran-Mantel-Haenszel|||||1.82|-0.55|0.7400
71881011|NCT04251910|143281248|SUPERIORITY|||||||0.1027|TWO_SIDED|95.0|||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (8 hours)||||0.1027
71881012|NCT04251910|143281248|SUPERIORITY|||||||0.7953|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (24 hours)||||0.7953
71881013|NCT04251910|143281248|SUPERIORITY|||||||0.1416|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.1416
71881014|NCT04251910|143281248|SUPERIORITY|||||||0.0658|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.0658
71881015|NCT04251910|143281249|SUPERIORITY|||||||0.876|||||||Mixed effects model|||Part A -30 mcg BXCL501 v/s Part A-Placebo (Day 1; 1 hour)||||0.8760
71881016|NCT04251910|143281249|SUPERIORITY|||||||0.9077|||||||Mixed effects model|||Part A 30 mcg BXCL501 v/s Part A-Placebo (Day 1; 2 hours)||||0.9077
71881017|NCT04251910|143281249|SUPERIORITY|||||||0.7208|||||||Mixed effects model|||Part A 30 mcg BXCL501 vs Part A-Placebo (Day1; 4 hours)||||0.7208
71881018|NCT04251910|143281249|SUPERIORITY|||||||0.3666|||||||Mixed effects model|||Part A BXCL501 30 mcg v/s Part A-Placebo(Day 1;8 hours)||||0.3666
71881019|NCT04251910|143281249|SUPERIORITY|||||||0.0191|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Placebo-Part A (Day1; 1 hour)||||0.0191
71881020|NCT04251910|143281249|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part A BXCL501 60 mcg v/s Part A-Placebo (Day 1; 2 hours)||||0.0006
71881021|NCT04251910|143281249|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 v/s Part A-Placebo (Day 1; 4 hours)||||<.0001
71881022|NCT04251910|143281249|SUPERIORITY|||||||0.0003|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1;8 hours)||||0.0003
71881023|NCT04251910|143281249|SUPERIORITY|||||||0.0006|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0006
71881024|NCT04251910|143281249|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0002
71881025|NCT04251910|143281249|SUPERIORITY|||||||0.0029|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0029
71881026|NCT04251910|143281249|SUPERIORITY|||||||0.2446|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.2446
71881027|NCT04251910|143281250|SUPERIORITY|||||||0.0926|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.0926
71881028|NCT04251910|143281250|SUPERIORITY|||||||0.3976|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.3976
71881029|NCT04251910|143281250|SUPERIORITY|||||||0.1169|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1169
71881030|NCT04251910|143281250|SUPERIORITY|||||||0.3786|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.3786
71881031|NCT04251910|143281250|SUPERIORITY|||||||0.564|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24hours)||||0.5640
71881032|NCT04251910|143281250|SUPERIORITY|||||||0.602|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.6020
71881033|NCT04251910|143281250|SUPERIORITY|||||||0.5875|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5875
71881034|NCT04251910|143281250|SUPERIORITY|||||||0.1055|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.1055
71881035|NCT04251910|143281250|SUPERIORITY|||||||0.0024|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0024
71881036|NCT04251910|143281250|SUPERIORITY|||||||0.0016|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0016
71881037|NCT04251910|143281250|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0002
71881038|NCT04251910|143281250|SUPERIORITY|||||||0.2039|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.2039
71881039|NCT04251910|143281250|SUPERIORITY|||||||0.1948|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 3)||||0.1948
71881040|NCT04251910|143281250|SUPERIORITY|||||||0.5615|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.5615
71881041|NCT04251910|143281250|SUPERIORITY|||||||0.8266|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.8266
71881042|NCT04251910|143281250|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
71881043|NCT04251910|143281250|SUPERIORITY|||||||0.0004|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0004
71881044|NCT04251910|143281250|SUPERIORITY|||||||0.1037|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.1037
71881045|NCT04251910|143281250|SUPERIORITY|||||||0.3267|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.3267
71881046|NCT04251910|143281250|SUPERIORITY|||||||0.0339|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 3)||||0.0339
71881047|NCT04251910|143281250|SUPERIORITY|||||||0.1892|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day7)||||0.1892
71881048|NCT04251910|143281251|SUPERIORITY|||||||0.3359|||||||Fisher Exact|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.3359
71881049|NCT04251910|143281251|SUPERIORITY|||||||0.0004|||||||Fisher Exact|||Part A-60 mcg BXCL501 V/S Part A-Placebo (2 hours post administration)||||0.0004
71881050|NCT04251910|143281251|SUPERIORITY|||||||0.0351|||||||Fisher Exact|||||||0.0351
71881051|NCT04251910|143281252|SUPERIORITY|||||||0.0952|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (2 hours)||||0.0952
71881052|NCT04251910|143281252|SUPERIORITY|||||||0.8977|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.8977
71881053|NCT04251910|143281252|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0002
71881054|NCT04251910|143281252|SUPERIORITY|||||||0.3147|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 2; 24 hours)||||0.3147
71881055|NCT04251910|143281252|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||<.0001
71881056|NCT04251910|143281252|SUPERIORITY|||||||0.1241|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 2; 24 hours)||||0.1241
71881057|NCT04251910|143281253|SUPERIORITY|||||||0.408|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.4080
71881058|NCT04251910|143281253|SUPERIORITY|||||||0.4198|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.4198
71687899|NCT04472494|142892039|SUPERIORITY||Estimate of Difference|-0.1||||0.9684|TWO_SIDED|95.0|-20.55|20.34|||Cochran-Mantel-Haenszel Chi-Square test||Estimate of Difference is based on minimum risk weights|||20.34|-20.55|0.9684
71687900|NCT04472494|142892040|SUPERIORITY||Odds Ratio (OR)|0.85||||0.8504|TWO_SIDED|95.0|0.18|3.97|||Cochran-Mantel-Haenszel|||||3.97|0.18|0.8504
71687901|NCT04472494|142892041|SUPERIORITY||Odds Ratio (OR)|2.29||||0.2724|TWO_SIDED|95.0|0.53|9.82|||Cochran-Mantel-Haenszel|||||9.82|0.53|0.2724
71687902|NCT04472494|142892041|SUPERIORITY||Estimate of difference|12.78|||||TWO_SIDED|95.0|-10.61|36.17|||||||Estimate of difference is based on minimum risk weights|36.17|-10.61|
71687903|NCT04472494|142892042|SUPERIORITY||Odds Ratio (OR)|2.03||||0.4734|TWO_SIDED|95.0|0.33|12.64|||Cochran-Mantel-Haenszel|||||12.64|0.33|0.4734
71881059|NCT04251910|143281253|SUPERIORITY|||||||0.037|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day1; 2 hours)||||0.0370
71687904|NCT04472494|142892042|SUPERIORITY||Estimate of difference|5.43|||||TWO_SIDED|95.0|-16.71|27.57|||||Estimate of difference is based on minimum risk weights|||27.57|-16.71|
71687905|NCT02131233|142892100|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|0.51|||||TWO_SIDED|95.0|-4.204|5.223|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||5.223|-4.204|
71881060|NCT04251910|143281253|SUPERIORITY|||||||0.1324|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.1324
71687906|NCT02131233|142892101|NON_INFERIORITY_OR_EQUIVALENCE|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|1.449|||||TWO_SIDED|95.0|-4.41|7.308|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA \<=100,000 copies/mL or HIV-1 RNA \>100,000 copies/mL)||7.308|-4.410|
71687907|NCT02131233|142892102|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1|||||TWO_SIDED|95.0|-30.9|26.7|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||26.7|-30.9|
71687908|NCT02131233|142892103|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-32.8|31.6|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.||31.6|-32.8|
71687909|NCT02095197|142892146|SUPERIORITY_OR_OTHER|||||||0.23|||||||Fisher Exact|||||||0.23
71687910|NCT02095197|142892147|SUPERIORITY_OR_OTHER|||||||0.47|||||||Chi-squared|||||||0.47
71881061|NCT04251910|143281253|SUPERIORITY|||||||0.0624|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 8 hours)||||0.0624
71881062|NCT04251910|143281253|SUPERIORITY|||||||0.6334|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 30 minutes)||||0.6334
71881063|NCT04251910|143281253|SUPERIORITY|||||||0.0275|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 1 hour)||||0.0275
71881064|NCT04251910|143281253|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
71881065|NCT04251910|143281253|SUPERIORITY|||||||0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 4 hours)||||0.0001
71881066|NCT04251910|143281253|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day1; 8 hours)||||<.0001
71881067|NCT04251910|143281253|SUPERIORITY|||||||0.2806|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 30 minutes)||||0.2806
71881068|NCT04251910|143281253|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 1 hour)||||0.0002
71881069|NCT04251910|143281253|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hour)||||<.0001
71881070|NCT04251910|143281253|SUPERIORITY|||||||0.0009|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 4 hours)||||0.0009
71881071|NCT04251910|143281253|SUPERIORITY|||||||0.0081|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 8 hours)||||0.0081
71881072|NCT04251910|143281254|SUPERIORITY|||||||0.0591|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||0.0591
71881073|NCT04251910|143281254|SUPERIORITY|||||||0.0966|||||||Mixed effects model|||Part A-30 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0966
71881074|NCT04251910|143281254|SUPERIORITY||||||<|0.0001|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 1; 2 hours)||||<.0001
71881075|NCT04251910|143281254|SUPERIORITY|||||||0.029|||||||Mixed effects model|||Part A-60 mcg BXCL501 V/S Part A-Placebo (Day 7)||||0.0290
71881076|NCT04251910|143281254|SUPERIORITY|||||||0.0937|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 1; 2 hours)||||0.0937
71881077|NCT04251910|143281254|SUPERIORITY|||||||0.2747|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (Day 7)||||0.2747
71881078|NCT04251910|143281257|SUPERIORITY|||||||0.0002|||||||Mixed effects model|||Part B-40 mcg-BXCL501 v/s Part B-Placebo (2 hours post administration)||||0.0002
71881079|NCT03002155|143281267|SUPERIORITY|||||||0.26||||||Not adjusted for multiple comparisons due to the pilot nature of the study, alpha level was 0.10.|ANOVA|||||||.26
71881080|NCT03002155|143281268|SUPERIORITY|||||||0.38|||||||ANOVA|||||||0.38
71881081|NCT03002155|143281269|SUPERIORITY|||||||0.24|||||||ANOVA|||For PROMIS Global Physical||||0.24
71881082|NCT03002155|143281269|SUPERIORITY|||||||0.8||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||For PROMIS Global Mental||||0.80
71881083|NCT03002155|143281270|SUPERIORITY|||||||0.81||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.81
71881084|NCT03002155|143281271|SUPERIORITY|||||||0.03||||||p-value is interaction of group and time. Alpha level= 0.10; not adjusted for multiple comparisons (pilot study)|ANOVA|||||||0.03
71881085|NCT00978029|143281277|SUPERIORITY_OR_OTHER||Percent Difference|6.9||||0.486|TWO_SIDED|95.0|-10.17|23.97|||Fisher Exact|||||23.97|-10.17|0.486
71881086|NCT00978029|143281277|SUPERIORITY_OR_OTHER||Percent Difference|16.9||||0.078|TWO_SIDED|95.0|0.01|33.83|||Fisher Exact|||||33.83|0.01|0.078
71881087|NCT01553188|143281286|SUPERIORITY|||||||0.44|||||||Log rank two-tailed p-value|||||||0.44
71881088|NCT01553188|143281288|SUPERIORITY|||||||0.26|||||||Log rank two-tailed p-value|||||||0.26
71881089|NCT04744207|143281299|SUPERIORITY||Least squares mean estimate|0.81|||<|0.05|TWO_SIDED|95.0|-2.48|4.1|||ANCOVA|||||4.10|-2.48|<0.05
71881090|NCT00777101|143281336|NON_INFERIORITY|Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.|Hazard Ratio (HR)|1.19||||0.231|TWO_SIDED|95.0|0.89|1.6|||Log Rank|The log-rank test comparing treatment groups is stratified by region.|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.|||1.60|0.89|0.231
71881091|NCT05376215|143281375|NON_INFERIORITY|The non-inferiority margin of -12.5 was used per the findings from Chisolm, et al (2005), see attached article. In that study, the smallest critical difference for the short term retest difference was 12.5 for the APHAB global score at the 90th percentile. For this study, non-inferiority is confirmed if Fitting Method B is no more than 12.5 percentage points below the mean global benefit score of Fitting Method A.||||||0.806|||||||Mixed Models Analysis|||||||0.806
71881092|NCT05376215|143281376|NON_INFERIORITY|The non-inferiority margin is -1.8 dB. This is based off of work by Killion (2004) in which the critical difference for 4 lists is 1.9 dB at the 95% confidence interval. Killion also found that if all 12 lists are presented, the mean SNR scores will differ by 1.8 dB 5% of the time.||||||0.889|||||||Mixed Models Analysis|||||||0.889
71881093|NCT01947816|143281380|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
71881094|NCT01947816|143281380|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
71881095|NCT01947816|143281380|SUPERIORITY|||||||0.5512|||||||paired t-test|||Change from Baseline When Discontinued||||0.5512
71881096|NCT01947816|143281380|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
71881097|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 4||||< 0.0001
71881098|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 8||||< 0.0001
71881099|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 16||||< 0.0001
71881100|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24||||< 0.0001
71881101|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52||||< 0.0001
71881102|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline when discontinued||||< 0.0001
71687911|NCT02095197|142892148|SUPERIORITY_OR_OTHER|||||||0.3|||||||Chi-squared|||||||0.30
71687912|NCT02095197|142892149|SUPERIORITY_OR_OTHER|||||||0.41|||||||Chi-squared|||||||0.41
71881103|NCT01947816|143281382|SUPERIORITY||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment||||< 0.0001
71882947|NCT01157078|143284951|SUPERIORITY_OR_OTHER||LS mean|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.446|TWO_SIDED|95.0|-0.31|0.14|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.||0.14|-0.31|0.446
71881104|NCT01301950|143281386|SUPERIORITY_OR_OTHER|||||||0.54|||||||ANOVA|||The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.||||0.54
71687913|NCT01462305|142892161|SUPERIORITY_OR_OTHER|||||||0.74||||||interaction effect and week of treatment condition|ANOVA|||To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the \~465nm (shorter wavelength) source compared with the \~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (\~465nm vs. \~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.||||0.74
71687914|NCT01462305|142892161|SUPERIORITY_OR_OTHER|||||||0.9||||||A repeated-measures ANOVA on the 29 subjects revealed no significant effect or interaction effect|ANOVA|||||||0.9
71881105|NCT02651584|143281391|NON_INFERIORITY|The p-value was based on the chi square test for non-inferiority with the margin of 10% point.|||||<|0.001|||||||Chi-squared|||||||<0.001
71881106|NCT02651584|143281392|SUPERIORITY|||||||0.004|||||||Wilcoxon Rank-Sum|||including subject self-reported opioid use||||0.004
71881107|NCT02651584|143281392|SUPERIORITY|||||||0.008|||||||Wilcoxon Rank-Sum|||not including self-reported opioid use||||0.008
71881108|NCT02651584|143281394|NON_INFERIORITY_OR_EQUIVALENCE|The p-value was based on the chi square test for non-inferiority with the margin of 15%.||||||0.006|||||||Chi-squared|||||||0.006
71881109|NCT03455491|143281395|SUPERIORITY|||||||0.3541|||||||Gekhan-Wilcoxon test|||||||0.3541
71881110|NCT03455491|143281396|SUPERIORITY|||||||0.3597|||||||Gekhan-Wilcoxon test|||||||0.3597
71881111|NCT03455491|143281398|SUPERIORITY|||||||0.4551|||||||ANOVA|one-way ANOVA||||||0.4551
71881112|NCT05248295|143281443|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of the variables. Below, the results are reported for the effect of production condition (Unison vs. Solo) for the group of interest, People with aphasia.|Odds Ratio (OR)|1.21|STANDARD_ERROR_OF_MEAN|0.13||0.077|TWO_SIDED|||||Results are reported for production condition for people with aphasia (experimental group).|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|People with aphasia (PWA) were not directly compared to controls since the finding of a lower % syllables correct in any condition in PWA would be trivial. Instead, within-groups analyses were conducted to understand how the experimental variables affected syllable accuracy within each group.||||0.077
71881113|NCT05248295|143281443|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the group of interest, People with aphasia.|||||>|0.1||||||Results are reported for Timing Condition for the People with aphasia.|Regression, Logistic|||||||>.1
71881114|NCT05248295|143281443|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the group of interest, People with aphasia.|Odds Ratio (OR)|1.55|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed as ((Unison Metrical)/(Unison Conversational)) / ((Solo Metrical)/(Solo Conversational))|||||<0.001
71881115|NCT05248295|143281443|OTHER||Odds Ratio (OR)|0.63|STANDARD_ERROR_OF_MEAN|0.14||0.036|TWO_SIDED|||||Results are reported for Production Condition for the Control group.|Regression, Logistic||OR computed with Unison as the numerator and Solo as the denominator|Separate regression models were used within each group. Here, the results are reported for the Control group.||||0.036
71881116|NCT05248295|143281443|OTHER|Below, the results are reported for the effect of timing condition (Metrical vs. Conversational) for the control group.|Odds Ratio (OR)|3.36|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED||||||Regression, Logistic||OR computed with Metrical as the numerator and Conversational as the denominator|||||<0.001
71881117|NCT05248295|143281443|OTHER|Below, the results are reported for the interaction effect between production condition and timing condition for the control group.|||||>|0.1|||||||Regression, Logistic|||||||>.1
71881118|NCT05248295|143281444|OTHER|Separate regression models were used within each group (People with aphasia and Controls) to independently assess the effects of Timing Condition. Production Condition is not included in the analysis since all timing data are from the unison production condition, by definition.|Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||Results are reported for people with aphasia (experimental group).|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group rather than a true comparator. Instead, within-groups analyses were conducted to understand how the experimental variable affected timing alignment in each group.||||<0.001
71881119|NCT05248295|143281444|OTHER||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.0|<|0.001|TWO_SIDED|||||Results are reported for the Control group.|Regression, Linear|||People with aphasia were not directly compared to Controls since the Control group is a context-providing reference group and not a true comparator. Instead, within-groups analyses were conducted to understand how experimental variables affected timing alignment in each group.||||<0.001
71881120|NCT03021499|143281445|SUPERIORITY||Odds Ratio (OR)|2.65|||<|0.001|TWO_SIDED|95.0|1.64|4.27|||Regression, Logistic|The model is based on a logistic regression with terms for treatment, baseline UPCR, biopsy class, MMF use at baseline and Region.||The primary endpoint was the proportion of subjects showing renal response at Week 52 as adjudicated by the Clinical Endpoints Committee.||4.27|1.64|<0.001
71881121|NCT03021499|143281446|SUPERIORITY||Hazard Ratio (HR)|2.02|||<|0.001|TWO_SIDED|95.0|1.51|2.7|||Log Rank|||||2.7|1.51|<0.001
71881122|NCT03021499|143281448|SUPERIORITY||Odds Ratio (OR)|2.23||||0.002|TWO_SIDED|95.0|1.34|3.72|||Regression, Cox||The hazard ratios are from a Cox's proportional hazards model with terms for treatment arm, baseline UPCR, biopsy class, MMF use at baseline and Region|||3.72|1.34|0.002
71881123|NCT03021499|143281449|SUPERIORITY||Odds Ratio (OR)|2.43|||<|0.001|TWO_SIDED|95.0|1.56|3.79||Week 24|Regression, Logistic||Week 24|Week 24||3.79|1.56|<0.001
71881124|NCT03021499|143281449|SUPERIORITY||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.45|3.51||Week 52|Regression, Logistic||Week 52|Week 52||3.51|1.45|<0.001
71881125|NCT03021499|143281450|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.349|TWO_SIDED|95.0|0.53|1.25|||Regression, Cox|||||1.25|0.53|0.349
71881126|NCT03021499|143281450|SUPERIORITY|||||||0.646|||||||Log Rank|||||||0.646
71881127|NCT03021499|143281453|SUPERIORITY||Hazard Ratio (HR)|2.05|||<|0.001|TWO_SIDED|95.0|1.62|2.6|||Log Rank|||||2.6|1.62|<0.001
71687915|NCT01462305|142892161|SUPERIORITY_OR_OTHER||||||<|0.0001||||||A repeated-measures ANOVA on the 29 subjects revealed significant effect of treatment week|ANOVA|||||||<0.0001
71687916|NCT01462305|142892163|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||ANOVA|||||||0.20
71881128|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 2||-1.9|-7.3|< 0.001
71881129|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-3.4|STANDARD_ERROR_OF_MEAN|1.39||0.014|TWO_SIDED|95.0|-6.1|-0.7|||Mixed Models Analysis|||Week 4||-0.7|-6.1|0.014
71881130|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-4.6|STANDARD_ERROR_OF_MEAN|1.39|<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||Mixed Models Analysis|||Week 8||-1.9|-7.3|< 0.001
71920767|NCT01258738|143362937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0098|TWO_SIDED|95.0|-1.26|-0.18|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.18|-1.26|0.0098
71920768|NCT01258738|143362938|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920769|NCT01258738|143362938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0037|TWO_SIDED|95.0|-1.26|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.25|-1.26|0.0037
71920770|NCT01258738|143362938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0044|TWO_SIDED|95.0|-1.35|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.25|-1.35|0.0044
71920771|NCT01258738|143362938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0104|TWO_SIDED|95.0|-1.26|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.17|-1.26|0.0104
71881131|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.39||0.017|TWO_SIDED|95.0|-6.0|-0.6|||Mixed Models Analysis|||Week 12||-0.6|-6|0.017
71881132|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-2.4|STANDARD_ERROR_OF_MEAN|1.4||0.085|TWO_SIDED|95.0|-5.1|0.3|||Mixed Models Analysis|||Week 16||0.3|-5.1|0.085
71881133|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.035|TWO_SIDED|95.0|-5.7|-0.2|||Mixed Models Analysis|||Week 20||-0.2|-5.7|0.035
71881134|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.41||0.121|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 24||0.6|-5|0.121
71881135|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-2.2|STANDARD_ERROR_OF_MEAN|1.42||0.12|TWO_SIDED|95.0|-5.0|0.6|||Mixed Models Analysis|||Week 30||0.6|-5|0.12
71920772|NCT01258738|143362938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.006|TWO_SIDED|95.0|-1.33|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.22|-1.33|0.0060
71920773|NCT01258738|143362939|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920774|NCT01258738|143362939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.2268|TWO_SIDED|95.0|-0.8|0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.19|-0.80|0.2268
71920775|NCT01258738|143362939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1145|TWO_SIDED|95.0|-0.93|0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.10|-0.93|0.1145
71920776|NCT01258738|143362939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0512|TWO_SIDED|95.0|-1.0|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.00|-1.00|0.0512
71920777|NCT01258738|143362939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0509|TWO_SIDED|95.0|-1.02|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.00|-1.02|0.0509
71920778|NCT01258738|143362940|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920779|NCT01258738|143362940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.243|TWO_SIDED|95.0|-0.79|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.20|-0.79|0.2430
71920780|NCT01258738|143362940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0384|TWO_SIDED|95.0|-1.09|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.09|0.0384
71920781|NCT01258738|143362940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0797|TWO_SIDED|95.0|-1.03|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.06|-1.03|0.0797
71687917|NCT00368459|142892172|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||For this pilot trial, we did not anticipate power to detect significant, clinically-meaningful between-group differences of the magnitude provided by FDA-approved AD therapies over a 12 month treatment period, but we specified that we would report trends (alpha \<0.1) as a guide to future effectiveness studies.||||>0.1
71687918|NCT00368459|142892173|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71881136|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-2.3|STANDARD_ERROR_OF_MEAN|1.43||0.102|TWO_SIDED|95.0|-5.1|0.5|||Mixed Models Analysis|||Week 36||0.5|-5.1|0.102
71881137|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-3.3|STANDARD_ERROR_OF_MEAN|1.44||0.022|TWO_SIDED|95.0|-6.1|0.5|||Mixed Models Analysis|||Week 42||0.5|-6.1|0.022
71687919|NCT00368459|142892174|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687920|NCT00368459|142892175|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687921|NCT00368459|142892176|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687922|NCT00368459|142892177|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687923|NCT00368459|142892178|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687924|NCT00368459|142892179|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Favoring placebo, unadjusted for multiple comparisons|ANCOVA|||||||<0.01
71687925|NCT00368459|142892180|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687926|NCT00368459|142892181|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||ANCOVA|||||||>0.1
71687927|NCT01690299|142892233|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|27.5|||<|0.0001|TWO_SIDED|95.0|14.9|40.1||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||40.1|14.9|< 0.0001
71881138|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-4.1|STANDARD_ERROR_OF_MEAN|1.45||0.004|TWO_SIDED|95.0|-7.0|-1.3|||Mixed Models Analysis|||Week 48||-1.3|-7|0.004
71881139|NCT03021499|143281454|SUPERIORITY||Mean Difference (Least Squares)|-2.8|STANDARD_ERROR_OF_MEAN|1.46||0.055|TWO_SIDED|95.0|-5.7|0.1|||Mixed Models Analysis|||Week 52||0.1|-5.7|0.055
71881140|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-0.56|STANDARD_ERROR_OF_MEAN|0.181||0.011|TWO_SIDED|95.0|-1.0|-0.13|||Mixed Models Analysis|||Week 2||-0.13|-1|0.011
71881141|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-0.76|STANDARD_ERROR_OF_MEAN|0.187|<|0.001|TWO_SIDED|95.0|-1.13|-0.4|||Mixed Models Analysis|||Week 4||-0.4|-1.13|<0.001
71881142|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-0.7|STANDARD_ERROR_OF_MEAN|0.181|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||Week 8||-0.34|-1.05|<0.001
71881143|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-0.94|STANDARD_ERROR_OF_MEAN|0.196|<|0.001|TWO_SIDED|95.0|-1.33|-0.55|||Mixed Models Analysis|||Week 12||-0.55|-1.33|<0.001
71881144|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.18|STANDARD_ERROR_OF_MEAN|0.214|<|0.001|TWO_SIDED|95.0|-1.6|-0.76|||Mixed Models Analysis|||Week 16||-0.76|-1.6|<0.001
71881145|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.16|STANDARD_ERROR_OF_MEAN|0.241|<|0.001|TWO_SIDED|95.0|-1.63|-0.68|||Mixed Models Analysis|||Week 20||-0.68|-1.63|<0.001
71881146|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.15|STANDARD_ERROR_OF_MEAN|0.222|<|0.001|TWO_SIDED|95.0|-1.59|-0.72|||Mixed Models Analysis|||Week 24||-0.72|-1.59|<0.001
71881147|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.02|STANDARD_ERROR_OF_MEAN|0.284|<|0.001|TWO_SIDED|95.0|-1.58|-0.46|||Mixed Models Analysis|||Week 30||-0.46|-1.58|<0.001
71881148|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.21|STANDARD_ERROR_OF_MEAN|0.264|<|0.001|TWO_SIDED|95.0|-1.73|-0.69|||Mixed Models Analysis|||Week 36||-0.69|-1.73|<0.001
71881149|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.37|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.87|-0.86|||Mixed Models Analysis|||Week 42||-0.86|-1.87|<0.001
71881150|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-1.06|STANDARD_ERROR_OF_MEAN|0.256|<|0.001|TWO_SIDED|95.0|-1.56|-0.55|||Mixed Models Analysis|||Week 48||-0.55|-1.56|<0.001
71881151|NCT03021499|143281455|SUPERIORITY||Mean Difference (Least Squares)|-0.99|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.52|-0.46|||Mixed Models Analysis|||Week 52||-0.46|-1.52|<0.001
71881152|NCT03021499|143281456|SUPERIORITY||Odds Ratio (OR)|2.44||||0.008|TWO_SIDED|95.0|1.26|4.71||Week 24|Regression, Logistic||Week 24|Week 24||4.71|1.26|0.008
71881153|NCT03021499|143281456|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.001|TWO_SIDED|95.0|1.48|4.0||Week 52|Regression, Logistic||Week 52|Week 52||4.00|1.48|<0.001
71881154|NCT03021499|143281457|SUPERIORITY||Least Squares Mean difference|-0.5||||0.373|TWO_SIDED|95.0|-1.6|0.6||Week 24|Mixed Models Analysis||Week 24|Week 24||0.6|-1.6|0.373
71881155|NCT03021499|143281457|SUPERIORITY||Least Squares Mean difference|-0.5||||0.277|TWO_SIDED|95.0|-1.4|0.4||Week 52|Mixed Models Analysis||Week 52|Week 52||0.4|-1.4|0.277
71881156|NCT03021499|143281458|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|1.389||0.733|TWO_SIDED|95.0|-3.21|2.26|||Mixed Models Analysis|||SF-36 Change from Baseline Week 24||2.26|-3.21|0.733
71881157|NCT03021499|143281458|SUPERIORITY||Mean Difference (Least Squares)|-0.37|STANDARD_ERROR_OF_MEAN|1.481||0.801|TWO_SIDED|95.0|-3.29|2.54|||Mixed Models Analysis|||SF-36 Change from Baseline at Week 52||2.54|-3.29|0.801
71881158|NCT03021499|143281458|SUPERIORITY||Mean Difference (Least Squares)|1.7|STANDARD_ERROR_OF_MEAN|1.442||0.239|TWO_SIDED|95.0|-1.14|4.54|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 24||4.54|-1.14|0.239
71881159|NCT03021499|143281458|SUPERIORITY||Mean Difference (Least Squares)|-0.6|STANDARD_ERROR_OF_MEAN|1.535||0.695|TWO_SIDED|95.0|-3.62|2.42|||Mixed Models Analysis|||LupusPRO HRQOL Change from Baseline at Week 52||2.42|-3.62|0.695
71881160|NCT03021499|143281458|SUPERIORITY||Mean Difference (Least Squares)|-1.89|STANDARD_ERROR_OF_MEAN|1.439||0.19|TWO_SIDED|95.0|-4.72|0.94|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 24||0.94|-4.72|0.19
71881161|NCT03021499|143281458|SUPERIORITY||Mean Difference (Least Squares)|0.826|STANDARD_ERROR_OF_MEAN|1.531||0.826|TWO_SIDED|95.0|-2.67|3.35|||Mixed Models Analysis|||LupusPRO non-HRQOL Change from Baseline at Week 52||3.35|-2.67|0.826
71881162|NCT04869345|143281498|SUPERIORITY||Odds Ratio (OR)|0.67||||0.684|TWO_SIDED|95.0|0.13|3.05||A priori threshold for statistical significance = 0.05.|Boschloo Test||Maximum likelihood estimate of the Odds Ratio comparing retention rate in LARKSPUR group to Attention Control group|||3.05|0.13|.684
71881163|NCT04869345|143281501|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|1.28||0.835|TWO_SIDED|95.0|-2.8|2.27||The threshold for statistical significance was 0.05.|Mixed Models Analysis|P-value adjusted using the Kenward-Roger (1997) degrees of freedom method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.27|-2.80|0.835
71881164|NCT04869345|143281501|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|1.29||0.732|TWO_SIDED|95.0|-2.12|3.0||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.00|-2.12|0.732
71882948|NCT01157078|143284952|SUPERIORITY_OR_OTHER||LS mean|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.178|TWO_SIDED|95.0|-0.06|0.33|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.||0.33|-0.06|0.178
71920782|NCT01258738|143362940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.2186|TWO_SIDED|95.0|-0.9|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.21|-0.90|0.2186
71920783|NCT01258738|143362941|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920784|NCT01258738|143362941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.141|TWO_SIDED|95.0|-0.96|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.14|-0.96|0.1410
71920785|NCT01258738|143362941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2299|TWO_SIDED|95.0|-0.88|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.21|-0.88|0.2299
71920786|NCT01258738|143362941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.3221|TWO_SIDED|95.0|-0.87|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.29|-0.87|0.3221
71920787|NCT01258738|143362941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1891|TWO_SIDED|95.0|-0.99|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.20|-0.99|0.1891
71920788|NCT01258738|143362942|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920789|NCT01258738|143362942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.108|TWO_SIDED|95.0|-0.9|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.09|-0.90|0.1080
71920790|NCT01258738|143362942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0389|TWO_SIDED|95.0|-1.06|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.03|-1.06|0.0389
71920791|NCT01258738|143362942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.1181|TWO_SIDED|95.0|-0.98|0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.11|-0.98|0.1181
71920792|NCT01258738|143362942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.2271|TWO_SIDED|95.0|-0.94|0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.22|-0.94|0.2271
71920793|NCT01258738|143362943|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920794|NCT01258738|143362943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.75||||0.0044|TWO_SIDED|95.0|-1.27|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.27|0.0044
71920795|NCT01258738|143362943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0455|TWO_SIDED|95.0|-1.09|-0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.01|-1.09|0.0455
71920796|NCT01258738|143362943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.175|TWO_SIDED|95.0|-0.91|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.17|-0.91|0.1750
71920797|NCT01258738|143362943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0379|TWO_SIDED|95.0|-1.12|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.03|-1.12|0.0379
71920798|NCT01258738|143362944|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71882949|NCT01157078|143284953|SUPERIORITY_OR_OTHER||LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.61||0.515|TWO_SIDED|95.0|-4.22|2.12|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||2.12|-4.22|0.515
71881165|NCT04869345|143281501|SUPERIORITY||Mean Difference (Net)|0.71|STANDARD_ERROR_OF_MEAN|1.38||0.609|TWO_SIDED|95.0|-2.05|3.47||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.47|-2.05|0.609
71881166|NCT04869345|143281502|SUPERIORITY||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|1.08||0.445|TWO_SIDED|95.0|-2.97|1.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.31|-2.97|0.445
71881167|NCT04869345|143281502|SUPERIORITY||Mean Difference (Final Values)|1.38|STANDARD_ERROR_OF_MEAN|1.09||0.209|TWO_SIDED|95.0|-0.78|3.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.54|-0.78|0.209
71881168|NCT04869345|143281502|SUPERIORITY||Mean Difference (Net)|2.21|STANDARD_ERROR_OF_MEAN|1.17||0.063|TWO_SIDED|95.0|-0.12|4.54||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Interference scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||4.54|-0.12|0.063
71881169|NCT04869345|143281503|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.95||0.792|TWO_SIDED|95.0|-1.63|2.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.13|-1.63|0.792
71881170|NCT04869345|143281503|SUPERIORITY||Mean Difference (Final Values)|1.2|STANDARD_ERROR_OF_MEAN|0.95||0.209|TWO_SIDED|95.0|-0.69|3.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Physical Functioning scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.09|-0.69|0.209
71882950|NCT01157078|143284954|SUPERIORITY_OR_OTHER||LS mean|0.024|STANDARD_ERROR_OF_MEAN|0.0226||0.298|TWO_SIDED|95.0|-0.0209|0.068||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||0.0680|-0.0209|0.298
71882951|NCT01157078|143284954|SUPERIORITY_OR_OTHER||LS mean|1.6|STANDARD_ERROR_OF_MEAN|2.34||0.484|TWO_SIDED|95.0|-2.98|6.26||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.||6.26|-2.98|0.484
71882952|NCT03962439|143284958|OTHER|Null-hypothesis significance testing|F-value|1.61||||0.211|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in episodic memory from baseline to 16 weeks interacted with condition (Time x Condition).||||.211
71882953|NCT03962439|143284960|OTHER|Null hypothesis significance testing|F-value|1.66||||0.203|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in speed of processing from baseline to 16 weeks interacted with condition (Time x Condition).||||.203
71882954|NCT03962439|143284962|OTHER|Null hypothesis significance testing|F-value|0.28||||0.76|TWO_SIDED|||||A priori threshold was two-sided 0.05. No adjustment for multiple comparisons.|ANCOVA|Adjusted for baseline age, sex, and education.||Repeated measures ANCOVA testing whether change in reasoning from baseline to week 16 interacted with condition (Time x Condition).||||.760
71881171|NCT04869345|143281503|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.66||0.151|TWO_SIDED|95.0|-0.35|2.26||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Pain Intensity scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||2.26|-0.35|0.151
71882955|NCT01192022|143284995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.87|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|2.55|9.29||Logistic regression model with treatment and pooled center as factors.|Regression, Logistic|||||9.29|2.55|<0.001
71881172|NCT04869345|143281504|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.47||0.601|TWO_SIDED|95.0|-2.14|3.69||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||3.69|-2.14|0.601
71881173|NCT04869345|143281504|SUPERIORITY||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|1.49||0.269|TWO_SIDED|95.0|-4.6|1.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||1.29|-4.60|0.269
71881174|NCT04869345|143281504|SUPERIORITY||Mean Difference (Net)|-2.43|STANDARD_ERROR_OF_MEAN|1.53||0.116|TWO_SIDED|95.0|-5.47|0.61||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS Fatigue scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.61|-5.47|0.116
71920799|NCT01258738|143362944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0826|TWO_SIDED|95.0|-0.98|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.06|-0.98|0.0826
71881175|NCT04869345|143281505|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.08||0.479|TWO_SIDED|95.0|-0.1|0.22||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.22|-0.10|0.479
71881176|NCT04869345|143281505|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.08||0.126|TWO_SIDED|95.0|-0.04|0.29||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.29|-0.04|0.126
71881177|NCT04869345|143281505|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.457|TWO_SIDED|95.0|-0.12|0.25||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline CESD-R-10 scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.25|-0.12|0.457
71881178|NCT04869345|143281506|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.13||0.389|TWO_SIDED|95.0|-0.15|0.38||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.38|-0.15|0.389
71881179|NCT04869345|143281506|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13||0.157|TWO_SIDED|95.0|-0.07|0.46||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.46|-0.07|0.157
71881180|NCT04869345|143281506|SUPERIORITY||Mean Difference (Net)|0.08|STANDARD_ERROR_OF_MEAN|0.14||0.593|TWO_SIDED|95.0|-0.21|0.36||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline mDES scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.36|-0.21|0.593
71920800|NCT01258738|143362944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1538|TWO_SIDED|95.0|-0.96|0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.15|-0.96|0.1538
71920801|NCT01258738|143362944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0728|TWO_SIDED|95.0|-1.04|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.05|-1.04|0.0728
71920802|NCT01258738|143362944|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0975|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.08|-0.99|0.0975
71920803|NCT01258738|143362945|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71687928|NCT01690299|142892234|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|35.9|||<|0.0001|TWO_SIDED|95.0|23.3|48.5||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||48.5|23.3|<0.0001
71687929|NCT01690299|142892235|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.0||||0.0005|TWO_SIDED|95.0|8.4|27.7||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The p-value is from a CMH test stratified by the BMI at screening.|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.|||27.7|8.4|0.0005
71687930|NCT01690299|142892235|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|25.2|||<|0.0001|TWO_SIDED|95.0|14.8|35.5||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.||||35.5|14.8|<0.0001
71881181|NCT04869345|143281507|SUPERIORITY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13||0.933|TWO_SIDED|95.0|-0.26|0.24||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.24|-0.26|0.933
71881182|NCT04869345|143281507|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.642|TWO_SIDED|95.0|-0.19|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|-0.19|0.642
71881183|NCT04869345|143281507|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.577|TWO_SIDED|95.0|-0.18|0.32||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PANAS-GEN scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.32|-0.18|0.577
71881184|NCT04869345|143281508|SUPERIORITY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.11||0.403|TWO_SIDED|95.0|-0.32|0.13||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.13|-0.32|0.403
71881185|NCT04869345|143281508|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.11||0.062|TWO_SIDED|95.0|-0.44|0.01||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference compares the LARKSPUR intervention minus the Attention Control.|The treatment difference (LARKSPUR Intervention vs. Attention Control) at Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PROMIS PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.01|-0.44|0.062
71881186|NCT04869345|143281508|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.269|TWO_SIDED|95.0|-0.33|0.09||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and two time points (Week 11, Week 16) and their interaction adjusting for baseline PSS scores. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.09|-0.33|0.269
71882956|NCT00781456|143285025|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.02|STANDARD_ERROR_OF_MEAN|0.43||0.954|TWO_SIDED|95.0|-0.82|0.87|||Regression, Logistic|Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|||0.87|-0.82|0.954
71920804|NCT01258738|143362945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0186|TWO_SIDED|95.0|-1.18|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.11|-1.18|0.0186
71920805|NCT01258738|143362945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0106|TWO_SIDED|95.0|-1.01|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.13|-1.01|0.0106
71920806|NCT01258738|143362945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0048|TWO_SIDED|95.0|-1.11|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.20|-1.11|0.0048
71920807|NCT01258738|143362945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0016|TWO_SIDED|95.0|-1.31|-0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.31|-1.31|0.0016
71920808|NCT01258738|143362946|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920809|NCT01258738|143362946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.0058|TWO_SIDED|95.0|-1.37|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.24|-1.37|0.0058
71687931|NCT01690299|142892236|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-31.4|||<|0.0001|TWO_SIDED|95.0|-43.33|-19.46|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-19.46|-43.33|<0.0001
71687932|NCT01690299|142892236|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-39.85|||<|0.0001|TWO_SIDED|95.0|-51.78|-27.92|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-27.92|-51.78|<0.0001
71920810|NCT01258738|143362946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0064|TWO_SIDED|95.0|-1.42|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.24|-1.42|0.0064
71920811|NCT01258738|143362946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.0002|TWO_SIDED|95.0|-1.85|-0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.60|-1.85|0.0002
71920812|NCT01258738|143362946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.0134|TWO_SIDED|95.0|-1.49|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.17|-1.49|0.0134
71920813|NCT01258738|143362947|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920814|NCT01258738|143362947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.0316|TWO_SIDED|95.0|-1.09|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.05|-1.09|0.0316
71920815|NCT01258738|143362947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0973|TWO_SIDED|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-0.99|0.0973
71687933|NCT01690299|142892237|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|29.4||||0.0002|TWO_SIDED|95.0|14.9|43.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||43.9|14.9|0.0002
71920816|NCT01258738|143362947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.0216|TWO_SIDED|95.0|-1.27|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.10|-1.27|0.0216
71920817|NCT01258738|143362947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.2425|TWO_SIDED|95.0|-1.03|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.03|0.2425
71920818|NCT01258738|143362948|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920819|NCT01258738|143362948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2688|TWO_SIDED|95.0|-0.92|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.26|-0.92|0.2688
71920820|NCT01258738|143362948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0866|TWO_SIDED|95.0|-1.17|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.08|-1.17|0.0866
71920821|NCT01258738|143362948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0277|TWO_SIDED|95.0|-1.34|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.08|-1.34|0.0277
71920822|NCT01258738|143362948|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.239|TWO_SIDED|95.0|-1.04|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.26|-1.04|0.2390
71920823|NCT01258738|143362949|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920824|NCT01258738|143362949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0928|TWO_SIDED|95.0|-1.0|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.00|0.0928
71920825|NCT01258738|143362949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.0139|TWO_SIDED|95.0|-1.27|-0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.15|-1.27|0.0139
71920826|NCT01258738|143362949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0017|TWO_SIDED|95.0|-1.53|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.36|-1.53|0.0017
71920827|NCT01258738|143362949|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.02||||0.0008|TWO_SIDED|95.0|-1.61|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.43|-1.61|0.0008
71920828|NCT01258738|143362950|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920829|NCT01258738|143362950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.4559|TWO_SIDED|95.0|-0.84|0.38|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.38|-0.84|0.4559
71920830|NCT01258738|143362950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0345|TWO_SIDED|95.0|-1.28|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.05|-1.28|0.0345
71920831|NCT01258738|143362950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68||||0.034|TWO_SIDED|95.0|-1.3|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.05|-1.30|0.0340
71920832|NCT01258738|143362950|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0634|TWO_SIDED|95.0|-1.24|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.03|-1.24|0.0634
71920833|NCT01258738|143362951|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920834|NCT01258738|143362951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.0007|TWO_SIDED|95.0|-1.56|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.43|-1.56|0.0007
71920835|NCT01258738|143362951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0073|TWO_SIDED|95.0|-1.39|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-0.22|-1.39|0.0073
71920836|NCT01258738|143362951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0094|TWO_SIDED|95.0|-1.48|-0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.21|-1.48|0.0094
71920837|NCT01258738|143362951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.87||||0.012|TWO_SIDED|95.0|-1.54|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.19|-1.54|0.0120
71920838|NCT01258738|143362952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.96||||0.0029|TWO_SIDED|95.0|7.54|32.37|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||32.37|7.54|0.0029
71920839|NCT01258738|143362952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.59||||0.01|TWO_SIDED|95.0|3.18|19.99|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||19.99|3.18|0.0100
71920840|NCT01258738|143362952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.75||||0.012|TWO_SIDED|95.0|3.62|23.89|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||23.89|3.62|0.0120
71920841|NCT01258738|143362952|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12||||0.0213|TWO_SIDED|95.0|3.04|27.2|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||27.20|3.04|0.0213
71920842|NCT01258738|143362953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.88||||0.2755|TWO_SIDED|95.0|-5.15|20.92|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||20.92|-5.15|0.2755
71920843|NCT01258738|143362953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.57||||0.195|TWO_SIDED|95.0|-4.39|21.54|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||21.54|-4.39|0.1950
71920844|NCT01258738|143362953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.99||||0.0278|TWO_SIDED|95.0|0.72|27.26|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||27.26|0.72|0.0278
71920845|NCT01258738|143362953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.29||||0.0174|TWO_SIDED|95.0|2.28|28.3|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||28.30|2.28|0.0174
71920846|NCT01258738|143362954|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920847|NCT01258738|143362954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54||||0.0201|TWO_SIDED|95.0|-0.99|-0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4||-0.09|-0.99|0.0201
71920848|NCT01258738|143362954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0558|TWO_SIDED|95.0|-1.02|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12||0.01|-1.02|0.0558
71920849|NCT01258738|143362955|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920850|NCT01258738|143362955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.6741|TWO_SIDED|95.0|-0.18|0.28|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.28|-0.18|0.6741
71920851|NCT01258738|143362955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.3896|TWO_SIDED|95.0|-0.33|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.13|-0.33|0.3896
71920852|NCT01258738|143362955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.7468|TWO_SIDED|95.0|-0.22|0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.31|-0.22|0.7468
71920853|NCT01258738|143362955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.6871|TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.23|-0.35|0.6871
71920854|NCT01258738|143362956|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71687934|NCT01690299|142892237|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|49.8|||<|0.0001|TWO_SIDED|95.0|36.9|62.7||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||62.7|36.9|<0.0001
71687935|NCT01690299|142892238|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-4.48|||<|0.0001|TWO_SIDED|95.0|-6.82|-2.14|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-2.14|-6.82|<0.0001
71687936|NCT01690299|142892238|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-3.94||||0.0004|TWO_SIDED|95.0|-6.27|-1.6|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||-1.60|-6.27|0.0004
71687937|NCT01690299|142892239|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|0.93||||0.7112|TWO_SIDED|95.0|-2.05|3.9|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||3.90|-2.05|0.7112
71687938|NCT01690299|142892239|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|2.22||||0.1719|TWO_SIDED|95.0|-0.75|5.19|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.||||5.19|-0.75|0.1719
71687939|NCT01690299|142892240|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|18.1||||0.0011|TWO_SIDED|95.0|7.6|28.6||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||28.6|7.6|0.0011
71687940|NCT01690299|142892240|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Difference|16.7||||0.0021|TWO_SIDED|95.0|6.5|26.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.|||26.9|6.5|0.0021
71687941|NCT01753115|142892245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of AUC|0.887|||||TWO_SIDED|90.0|0.831|0.948||||||Analysis of Ciprofloxacin Area Under the Curve at Day 5 and Day 44.||0.948|0.831|
71687942|NCT01753115|142892245|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Equivalence margin is 0.80 - 1.25.|Ratio of Cmax|0.944|||||TWO_SIDED|90.0|0.852|1.046||||||Analysis of Cmax at Day 5 and Day 44||1.046|0.852|
71687943|NCT01753115|142892246|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin is 0.67.|Ratio of GMT|1.267|||||TWO_SIDED|95.0|0.898|1.787||||||||1.787|0.898|
71687944|NCT01461473|142892267|SUPERIORITY_OR_OTHER|||||||0.2067|||||||Analysis of covariance (GLM)|||These data were analyzed using an analysis of covariance via general linear model (GLM). The GLM has an indicator variable for PAP vs. OA plus covariates for baseline apnea-hypopnea index, gender, site and baseline NMAP. The primary hypothesis tested is that the 2-month means differ between study arms, after adjustment for the above covariates. A Wald statistic was constructed for hypothesis testing.||||0.2067
71687945|NCT01461473|142892268|SUPERIORITY_OR_OTHER|||||||0.3902|||||||GLMM|||Generalized linear mixed model (GLMM) was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3902
71687946|NCT01461473|142892269|SUPERIORITY_OR_OTHER|||||||0.9319|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.9319
71687947|NCT01461473|142892270|SUPERIORITY_OR_OTHER|||||||0.3895|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.||||0.3895
71687948|NCT01461473|142892271|SUPERIORITY_OR_OTHER|||||||0.3449|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.3449
71687949|NCT01461473|142892272|SUPERIORITY_OR_OTHER|||||||0.1531|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.||||0.1531
71687950|NCT01778751|142892321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.012|TWO_SIDED|95.0|-1.7|-0.2|||Mixed Models Analysis|||Comparison at 3 months||-0.2|-1.7|0.012
71687951|NCT01778751|142892321|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.05|TWO_SIDED|95.0|-2.0|0.0|||Mixed Models Analysis|||Comparison at 6 months||-0.0|-2.0|0.050
71687952|NCT01778751|142892322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9||||0.303|TWO_SIDED|95.0|-2.7|8.4|||Mixed Models Analysis|||Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.||8.4|-2.7|0.303
71687953|NCT01778751|142892322|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.7||||0.027|TWO_SIDED|95.0|0.9|14.4|||Mixed Models Analysis|||Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.||14.4|0.9|0.027
71687954|NCT01778751|142892323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.83|TWO_SIDED|95.0|0.35|2.34|||Generalized estimating equation (GEE)|||||2.34|0.35|0.830
71687955|NCT01778751|142892323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.97|TWO_SIDED|95.0|0.33|3.19|||Generalized Estimating Equation (GEE)|||Comparison at 6 months||3.19|0.33|0.970
71687956|NCT01778751|142892324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.428|TWO_SIDED|95.0|-3.3|1.4|||Mixed Models Analysis|||Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||1.4|-3.3|0.428
71920855|NCT01258738|143362956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.4332|TWO_SIDED|95.0|-0.57|1.32|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||1.32|-0.57|0.4332
71687957|NCT01778751|142892324|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.1||||0.397|TWO_SIDED|95.0|-1.4|3.6|||Mixed Models Analysis|||Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.||3.6|-1.4|0.397
71687958|NCT01454414|142892325|SUPERIORITY_OR_OTHER_LEGACY||Protective effectiveness= 1 - rate ratio|0.646||||0.004|TWO_SIDED|95.0|0.288|0.824|||Poisson regression|||Protective effectiveness (1 - the incidence rate ratio) and 95% CIs for comparing reported tick bites between the treatment and control groups were calculated using a GEE model with a Poisson distribution and log link, and included terms for treatment, year of follow-up, and the interaction of treatment and year of follow-up, with an offset variable for log outdoor work hours.||0.824|0.288|0.004
71687959|NCT04679948|142892341|OTHER||Ratio of GLSMs [%]|112.06|||||TWO_SIDED|90.0|101.02|124.3|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) =16.2."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||124.30|101.02|
71687960|NCT04679948|142892342|OTHER||Ratio of GLSMs [%]|96.74|||||TWO_SIDED|90.0|91.55|102.23|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + caffeine/GLSM of caffeine). Intra-individual geometric coefficient of variation (gCV \[%\]) = 8.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||102.23|91.55|
71920856|NCT01258738|143362956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.9947|TWO_SIDED|95.0|-0.98|0.98|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.98|-0.98|0.9947
71920857|NCT01258738|143362956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.74||||0.1558|TWO_SIDED|95.0|-0.28|1.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.75|-0.28|0.1558
71920858|NCT01258738|143362956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.0488|TWO_SIDED|95.0|0.03|2.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||2.39|0.03|0.0488
71920859|NCT01258738|143362957|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920860|NCT01258738|143362957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.7645|TWO_SIDED|95.0|-2.06|2.8|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||2.80|-2.06|0.7645
71920861|NCT01258738|143362957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.03||||0.4178|TWO_SIDED|95.0|-1.48|3.55|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||3.55|-1.48|0.4178
71920862|NCT01258738|143362957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.06||||0.443|TWO_SIDED|95.0|-1.67|3.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||3.79|-1.67|0.4430
71920863|NCT01258738|143362957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.39||||0.1095|TWO_SIDED|95.0|-0.54|5.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||5.31|-0.54|0.1095
71920864|NCT01258738|143362958|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920865|NCT01258738|143362958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9504|TWO_SIDED|95.0|-0.46|0.49|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.49|-0.46|0.9504
71920866|NCT01258738|143362958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4971|TWO_SIDED|95.0|-0.7|0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.34|-0.70|0.4971
71920867|NCT01258738|143362958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.8999|TWO_SIDED|95.0|-0.47|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.54|-0.47|0.8999
71920868|NCT01258738|143362958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9712|TWO_SIDED|95.0|-0.6|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.62|-0.60|0.9712
71920869|NCT01258738|143362959|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920870|NCT01258738|143362959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.4556|TWO_SIDED|95.0|-1.46|3.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||3.24|-1.46|0.4556
71920871|NCT01258738|143362959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.85||||0.0543|TWO_SIDED|95.0|-0.05|5.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||5.75|-0.05|0.0543
71920872|NCT01258738|143362959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.26||||0.1754|TWO_SIDED|95.0|-1.02|5.53|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||5.53|-1.02|0.1754
71920873|NCT01258738|143362959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.45||||0.3985|TWO_SIDED|95.0|-1.93|4.82|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||4.82|-1.93|0.3985
71687961|NCT04679948|142892343|OTHER||Ratio of GLSMs [%]|110.38|||||TWO_SIDED|90.0|107.15|113.71|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) =4.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.71|107.15|
71687962|NCT04679948|142892344|OTHER||Ratio of GLSMs [%]|108.47|||||TWO_SIDED|90.0|104.11|113.01|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + warfarin/GLSM of Warfarin). Intra-individual geometric coefficient of variation (gCV \[%\]) = 6.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.01|104.11|
71687963|NCT04679948|142892345|OTHER||Ratio of GLSM [%]|99.74|||||TWO_SIDED|90.0|89.66|110.95|||||"Ratio of Geometric Least Squares Means (GLSM) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =12.3."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||110.95|89.66|
71687964|NCT04679948|142892346|OTHER||Ratio of GLSMs [%]|71.32|||||TWO_SIDED|90.0|44.64|113.96|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + omeprazole/GLSM of Omeprazole). Intra-individual geometric coefficient of variation (gCV \[%\]) =87.8."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||113.96|44.64|
71687965|NCT04679948|142892347|OTHER||Ratio of GLSMs [%]|126.85|||||TWO_SIDED|90.0|119.15|135.05|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =10.1."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||135.05|119.15|
71687966|NCT04679948|142892348|OTHER||Ratio of GLSMs [%]|130.25|||||TWO_SIDED|90.0|121.25|139.92|||||"Ratio of Geometric Least Squares Means (GLSMs) was calculated as (GLSM of BI 730357 + midazolam/GLSM of Midazolam). Intra-individual geometric coefficient of variation (gCV \[%\]) =11.6."|The statistical model used for the analysis of the primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. That is, the PK endpoints were logtransformed (natural logarithm) prior to fitting the ANOVA model. These quantities were then back-transformed to the original scale to provide the point estimate and 90% CIs for each endpoint. This model included effects accounting for the following sources of variation: subjects (random effect) and treatment (fixed effect).||139.92|121.25|
71687967|NCT02371668|142892349|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71687968|NCT02371668|142892350|SUPERIORITY|||||||0.114|||||||Fisher Exact|||||||0.114
71882957|NCT00781456|143285026|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|0.44||0.479|TWO_SIDED|95.0|-0.55|1.17||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with \>=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.||1.17|-0.55|0.479
71687969|NCT02371668|142892351|SUPERIORITY|||||||0.4989|||||||Wilcoxon (Mann-Whitney)|||||||0.4989
71687970|NCT02371668|142892352|SUPERIORITY|||||||0.1412|||||||Wilcoxon (Mann-Whitney)|||||||0.1412
71687971|NCT02371668|142892353|SUPERIORITY|||||||0.137|||||||Fisher Exact|||||||0.137
71687972|NCT02371668|142892354|SUPERIORITY|||||||0.2445|||||||Wilcoxon (Mann-Whitney)|||||||0.2445
71687973|NCT02371668|142892355|SUPERIORITY|||||||0.045|||||||Fisher Exact|||||||0.045
71687974|NCT02371668|142892356|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.230
71687975|NCT02371668|142892357|SUPERIORITY|||||||0.646|||||||Fisher Exact|||||||0.646
71687976|NCT04227405|142892361|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||>.05
71687977|NCT04227405|142892361|SUPERIORITY||Slope|1.59|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change between pre-test and post-test for the Positive Conflict Management subscale using multilevel modeling||||<.001
71920874|NCT01258738|143362960|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920875|NCT01258738|143362960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.2823|TWO_SIDED|95.0|-0.18|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.62|-0.18|0.2823
71920876|NCT01258738|143362960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.4029|TWO_SIDED|95.0|-0.23|0.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.58|-0.23|0.4029
71920877|NCT01258738|143362960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.511|TWO_SIDED|95.0|-0.25|0.51|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.51|-0.25|0.5110
71687978|NCT04227405|142892361|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Positive Conflict Management subscale||||<.001
71687979|NCT04227405|142892361|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Negative Conflict Management for the Control Group||||>.05
71687980|NCT04227405|142892361|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.29|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the Negative Conflict Management subscale||||<.01
71687981|NCT04227405|142892361|SUPERIORITY||Slope|-1.0|STANDARD_ERROR_OF_MEAN|0.36|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Negative Conflict Management subscale||||<.01
71687982|NCT04227405|142892361|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes in the Relationship Quality subscale from Pre-test to post-test in the control group||||<.05
71687983|NCT04227405|142892361|SUPERIORITY||Slope|0.86|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes in the Relationship Quality Subscale from pretest to posttest in the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71920878|NCT01258738|143362960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.5844|TWO_SIDED|95.0|-0.32|0.56|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.56|-0.32|0.5844
71687984|NCT04227405|142892361|SUPERIORITY||Slope|0.53|STANDARD_ERROR_OF_MEAN|0.22|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Qualitty subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
71687985|NCT04227405|142892361|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.11|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.05
71687986|NCT04227405|142892361|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Emotional Abuse subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71881187|NCT04869345|143281509|SUPERIORITY||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|0.07|0.33||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.33|0.07|0.003
71881188|NCT04869345|143281509|SUPERIORITY||Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.07||0.006|TWO_SIDED|95.0|0.05|0.31||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.31|0.05|0.006
71920879|NCT01258738|143362961|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920880|NCT01258738|143362961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0129|TWO_SIDED|95.0|-0.95|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.11|-0.95|0.0129
71920881|NCT01258738|143362961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.6003|TWO_SIDED|95.0|-0.61|0.35|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.35|-0.61|0.6003
71920882|NCT01258738|143362961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0911|TWO_SIDED|95.0|-0.89|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.07|-0.89|0.0911
71920883|NCT01258738|143362961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.3144|TWO_SIDED|95.0|-0.73|0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.24|-0.73|0.3144
71920884|NCT01258738|143362962|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920885|NCT01258738|143362962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.6476|TWO_SIDED|95.0|-0.46|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2||0.29|-0.46|0.6476
71920886|NCT01258738|143362962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9777|TWO_SIDED|95.0|-0.4|0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4||0.39|-0.40|0.9777
71920887|NCT01258738|143362962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.4453|TWO_SIDED|95.0|-0.28|0.65|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8||0.65|-0.28|0.4453
71920888|NCT01258738|143362962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.5782|TWO_SIDED|95.0|-0.33|0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12||0.60|-0.33|0.5782
71920889|NCT01258738|143362963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
71920890|NCT01258738|143362964|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920891|NCT01258738|143362964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.93|||<|0.001|TWO_SIDED|95.0|-4.16|-1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-1.70|-4.16|<0.001
71920892|NCT01258738|143362965|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920893|NCT01258738|143362965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0414|TWO_SIDED|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||-0.04|-1.88|0.0414
71920894|NCT01258738|143362966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.0132|TWO_SIDED|95.0|-0.72|-0.08|||ANCOVA|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."||-0.08|-0.72|0.0132
71920895|NCT01258738|143362967|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920896|NCT01258738|143362967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.2438|TWO_SIDED|95.0|-0.52|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.13|-0.52|0.2438
71920897|NCT01258738|143362967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.1958|TWO_SIDED|95.0|-0.42|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.09|-0.42|0.1958
71687987|NCT04227405|142892361|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.16|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Emotional Abuse subscale|The expected decrease from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.05
71687988|NCT04227405|142892361|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to posttest in the Relationship Satisfaction subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
71687989|NCT04227405|142892361|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Changes from pre-test to posttest in the Relationship satisfaction subscale for the intervention group||||<.001
71687990|NCT04227405|142892361|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Satisfactionn subscale||||<.001
71687991|NCT04227405|142892361|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the control group||||>.05
71687992|NCT04227405|142892361|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Relationship Commitment subscale for the intervention group||||<.001
71881189|NCT04869345|143281509|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.796|TWO_SIDED|95.0|-0.15|0.12||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.12|-0.15|0.796
71881190|NCT04869345|143281510|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.02||0.758|TWO_SIDED|95.0|-0.03|0.05||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 11 minus Baseline) minus the change for the Attention Control (Week 11 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 11 (Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.05|-0.03|0.758
71920898|NCT01258738|143362967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.1624|TWO_SIDED|95.0|-0.46|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.08|-0.46|0.1624
71920899|NCT01258738|143362967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0091|TWO_SIDED|95.0|-0.54|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.08|-0.54|0.0091
71920900|NCT01258738|143362968|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71687993|NCT04227405|142892361|SUPERIORITY||Slope|0.27|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Relationship Commitment subscale||||<.001
71920901|NCT01258738|143362968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0836|TWO_SIDED|95.0|-1.32|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.08|-1.32|0.0836
71881191|NCT04869345|143281510|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.02||0.88|TWO_SIDED|95.0|-0.04|0.04||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Baseline) minus the change for the Attention Control (Week 16 minus Baseline).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Baseline to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.04|-0.04|0.880
71881192|NCT04869345|143281510|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.652|TWO_SIDED|95.0|-0.05|0.03||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Degrees of freedom and standard error estimates were adjusted using the Kenward-Roger (1997) method.|The estimated Mean Difference (Net) compares the change for the LARKSPUR intervention (Week 16 minus Week 11) minus the change for the Attention Control (Week 16 minus Week 11).|The treatment difference (LARKSPUR Intervention vs. Attention Control) in change from Week 11 (Post-Intervention) to Week 16 (1 Month Post-Intervention) was tested using a mixed effects model with two treatment groups and three time points (Baseline, Week 11, Week 16) and their interaction while accounting for heterogeneous (random slopes) linear daily trends. Sample size was chosen based on feasibility indicators (recruitment, retention, adherence) rather than on formal power analyses.||0.03|-0.05|0.652
71881193|NCT01999465|143281590|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms.||||||0.40
71881194|NCT01999465|143281591|OTHER|||||||0.2|||||||t-test, 2 sided|||||||0.20
71881195|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.0034||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.0034
71881196|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.26||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.||||0.2600
71881197|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated measures Analysis of Variance|||60 minutes after study drug injection.||||0.0001
71881198|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.0039||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0039
71881199|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.93||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.9300
71881200|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.0031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.||||0.0031
71881201|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.019||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0190
71881202|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.92||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.9200
71881203|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.015||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.||||0.0150
71881204|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.095||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0950
71881205|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.6||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.6000
71881206|NCT00916357|143281671|SUPERIORITY_OR_OTHER|||||||0.031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.||||0.0310
71920902|NCT01258738|143362968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5402|TWO_SIDED|95.0|-1.02|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.54|-1.02|0.5402
71881207|NCT00916357|143281672|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
71881208|NCT00916357|143281672|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.1800
71881209|NCT00916357|143281672|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
71881210|NCT00916357|143281673|SUPERIORITY_OR_OTHER|||||||0.0045||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0045
71881211|NCT00916357|143281673|SUPERIORITY_OR_OTHER|||||||0.48||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.4800
71881212|NCT00916357|143281673|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0006
71920903|NCT01258738|143362968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.8167|TWO_SIDED|95.0|-0.69|0.87|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.87|-0.69|0.8167
71881213|NCT00916357|143281674|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
71881214|NCT00916357|143281674|SUPERIORITY_OR_OTHER|||||||0.0016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0016
71881215|NCT00916357|143281674|SUPERIORITY_OR_OTHER|||||||0.1||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.1000
71881216|NCT00916357|143281675|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone + Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
71881217|NCT00916357|143281675|SUPERIORITY_OR_OTHER|||||||0.3||||||Treatment comparison for Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.3000
71881218|NCT00916357|143281675|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
71881219|NCT00916357|143281676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||<0.0001
71881220|NCT00916357|143281676|SUPERIORITY_OR_OTHER|||||||0.77||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.7700
71881221|NCT00916357|143281676|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||<0.0001
71881222|NCT00916357|143281677|SUPERIORITY_OR_OTHER|||||||0.01||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.0100
71881223|NCT00916357|143281677|SUPERIORITY_OR_OTHER|||||||0.82||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8200
71881224|NCT00916357|143281677|SUPERIORITY_OR_OTHER|||||||0.0056||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.0056
71881225|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.064||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.064
71881226|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.47||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.47
71881227|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.012||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>160 milligrams per deciliter (mg/dL)||||0.012
71881228|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.099||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.099
71881229|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.46
71881230|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.02||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \>140 milligrams per deciliter (mg/dL)||||0.020
71920904|NCT01258738|143362968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.9891|TWO_SIDED|95.0|-0.72|0.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.73|-0.72|0.9891
71920905|NCT01258738|143362969|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71881231|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.13||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.13
71881232|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.41||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.41
71687994|NCT04227405|142892361|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Depression subscale for the control group||||<.001
71920906|NCT01258738|143362969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.6148|TWO_SIDED|95.0|-0.08|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.05|-0.08|0.6148
71920907|NCT01258738|143362969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.2547|TWO_SIDED|95.0|-0.11|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.03|-0.11|0.2547
71881233|NCT00916357|143281678|SUPERIORITY_OR_OTHER|||||||0.46||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) \<70 milligrams per deciliter (mg/dL)||||0.46
71881234|NCT00916357|143281679|SUPERIORITY_OR_OTHER|||||||0.016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.016
71881235|NCT00916357|143281679|SUPERIORITY_OR_OTHER|||||||0.88||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||||||0.8800
71881236|NCT00916357|143281679|SUPERIORITY_OR_OTHER|||||||0.011||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||||||0.011
71881237|NCT00916357|143281681|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
71881238|NCT00916357|143281681|SUPERIORITY_OR_OTHER|||||||0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||0.1800
71881239|NCT00916357|143281681|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve \[AUC\])||||<0.0001
71881240|NCT00916357|143281681|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison for Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
71881241|NCT00916357|143281681|SUPERIORITY_OR_OTHER|||||||0.72||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||0.7200
71881242|NCT00916357|143281681|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve \[AUC\])||||<0.0001
71881243|NCT01308008|143281682|SUPERIORITY||coefficient|0.05||||0.16|TWO_SIDED|95.0|-0.02|0.13|||Regression, Logistic|||||0.13|-0.02|0.16
71881244|NCT01308008|143281683|SUPERIORITY||coefficient|34.0||||0.17|TWO_SIDED|95.0|-15.0|83.0|||Regression, Logistic|||||83|-15|0.17
71920908|NCT01258738|143362969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.1208|TWO_SIDED|95.0|-0.08|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.01|-0.08|0.1208
71920909|NCT01258738|143362969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.8291|TWO_SIDED|95.0|-0.13|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.17|-0.13|0.8291
71920910|NCT01258738|143362970|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71881245|NCT01308008|143281684|SUPERIORITY||coefficient|-8.7||||0.5|TWO_SIDED|95.0|-35.0|17.0|||Regression, Logistic|||||17|-35|0.5
71881246|NCT01417195|143281685|NON_INFERIORITY_OR_EQUIVALENCE|The pre-defined non-inferiority margin for the lower limit of the 95% CI for the difference in fertilization rate was below -12%.|Mean Difference (Final Values)|3.6|||||TWO_SIDED|95.0|-4.3|11.5|||||"Mean difference = Menopur/Bravelle - Menopur.~95% CI is based on Student's t-distribution, assuming equal variances."|||11.5|-4.3|
71881247|NCT03357731|143281691|SUPERIORITY||Mean Difference (Net)|-2.15|STANDARD_ERROR_OF_MEAN|0.9242||0.027|TWO_SIDED|95.0|-4.0432|-0.257|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.2570|-4.0432|0.027
71881248|NCT03357731|143281692|SUPERIORITY||Mean Difference (Net)|0.193|STANDARD_ERROR_OF_MEAN|0.9832||0.846|TWO_SIDED|95.0|-1.8176|2.2042|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||2.2042|-1.8176|0.846
71881249|NCT03357731|143281693|SUPERIORITY||Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|0.93||0.177|TWO_SIDED|95.0|-0.62|3.19|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||3.19|-0.62|0.177
71920911|NCT01258738|143362970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.3536|TWO_SIDED|95.0|-0.64|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||0.23|-0.64|0.3536
71687995|NCT04227405|142892361|SUPERIORITY||Slope|-0.81|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Changes from pre-test to posttest in the Depression subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71881250|NCT03357731|143281693|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.48||0.839|TWO_SIDED|95.0|-1.08|0.88|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.88|-1.08|0.839
71881251|NCT03357731|143281694|SUPERIORITY||Mean Difference (Net)|-0.0977|STANDARD_ERROR_OF_MEAN|0.03308||0.007|TWO_SIDED|95.0|-0.16634|-0.02915|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||-0.02915|-0.16634|0.007
71920912|NCT01258738|143362970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0769|TWO_SIDED|95.0|-0.97|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||0.05|-0.97|0.0769
71920913|NCT01258738|143362970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.4698|TWO_SIDED|95.0|-0.7|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||0.33|-0.70|0.4698
71920914|NCT01258738|143362970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0167|TWO_SIDED|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.12|-1.19|0.0167
71920915|NCT01258738|143362971|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were \<0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.||||<0.001
71920916|NCT01258738|143362971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|||<|0.0001|TWO_SIDED|95.0|-4.39|-1.66|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.66|-4.39|<0.0001
71920917|NCT01258738|143362971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.86||||0.0008|TWO_SIDED|95.0|-6.09|-1.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-1.62|-6.09|0.0008
71687996|NCT04227405|142892361|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Depression subscale||||>.05
71687997|NCT04227405|142892361|SUPERIORITY||Slope|-0.26|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the control group||||>.05
71687998|NCT04227405|142892361|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Anxiety subscale for the intervention group||||<.001
71881252|NCT03357731|143281694|SUPERIORITY||Mean Difference (Net)|-0.0371|STANDARD_ERROR_OF_MEAN|0.02194||0.103|TWO_SIDED|95.0|-0.08243|0.00814|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.00814|-0.08243|0.103
71881253|NCT03357731|143281695|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.037||0.003|TWO_SIDED|95.0|-0.205|-0.051|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||-0.051|-0.205|0.003
71881254|NCT03357731|143281695|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.904|TWO_SIDED|95.0|-0.051|0.057|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/A ratio||0.057|-0.051|0.904
71687999|NCT04227405|142892361|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test and post-test in the intervention group were not significantly different from the change from pre-test and post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Anxiety subscale||||>.05
71688000|NCT04227405|142892361|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.04|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Budgeting subscale for the control group||||<.05
71688001|NCT04227405|142892361|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Budgeting subscale for the intervention group||||<.001
71688002|NCT04227405|142892361|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Budgeting subscale||||<.10
71688003|NCT04227405|142892361|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the control group||||<.10
71688004|NCT04227405|142892361|SUPERIORITY||Slope|-0.21|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Difficulties to Pay Bills subscale for the intervention group||||<.001
71688005|NCT04227405|142892361|SUPERIORITY||Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Difficulties to Pay Bills subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
71688006|NCT04227405|142892361|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the control group||||>.05
71688007|NCT04227405|142892361|SUPERIORITY||Slope|0.28|STANDARD_ERROR_OF_MEAN|0.13|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in Time with Partner subscale for the intervention group||||<.05
71688008|NCT04227405|142892361|SUPERIORITY||Slope|0.16|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to pos-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time with Partner subscale||||>.05
71688009|NCT04227405|142892361|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Positive values indicate an increase whereas a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for control group||||>.05
71688010|NCT04227405|142892361|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in banking subscale for the intervention group||||>.05
71688011|NCT04227405|142892361|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in Banking subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|||>.05
71688012|NCT04227405|142892361|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the control group||||>.05
71688013|NCT04227405|142892361|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in parenting stress subscale for the intervention group||||>.05
71688014|NCT04227405|142892361|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.11|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Parenting stresss subscale||||>.05
71881255|NCT03357731|143281695|SUPERIORITY||Mean Difference (Net)|-1.66|STANDARD_ERROR_OF_MEAN|0.527||0.006|TWO_SIDED|95.0|-2.763|-0.549|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||-0.549|-2.763|0.006
71688015|NCT04227405|142892361|SUPERIORITY||Slope|0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the control group||||<.001
71688016|NCT04227405|142892361|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in conflict management satisfaction subscale for the intervention group||||<.001
71688017|NCT04227405|142892361|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||The increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Conflict Management Satisfaction subscale||||<.001
71688018|NCT04227405|142892362|SUPERIORITY||Slope|0.18|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
71688019|NCT04227405|142892362|SUPERIORITY||Slope|1.53|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Positive Conflict Management subscale for the intervention group||||<.001
71688020|NCT04227405|142892362|SUPERIORITY||Slope|1.35|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Positive Conflict Management subscale|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Positive Conflict Management subscale||||<.01
71688021|NCT04227405|142892362|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.28|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Negative Conflict subscale for the control group||||>.05
71688022|NCT04227405|142892362|SUPERIORITY||Slope|-1.4|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Changes from pre-test to Follow-up in the Negative Conflict Manageement subscale for the intervention group|A positive value indicates an increase while a negative value indicates a decrease|||<.001
71688023|NCT04227405|142892362|SUPERIORITY||Slope|-0.99|STANDARD_ERROR_OF_MEAN|0.44|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-i\[in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Negative Conflict Management subscale||||<.01
71688024|NCT04227405|142892362|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.17|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
71688025|NCT04227405|142892362|SUPERIORITY||Slope|0.91|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Quality subscale for the intervention group||||<.001
71688026|NCT04227405|142892362|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.26|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables. Pvalue set at \<.05|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up n the Relationship Quality subscale||||<.10
71688027|NCT04227405|142892362|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group||||<.10
71688028|NCT04227405|142892362|SUPERIORITY||Slope|-0.71|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Emotional Abuse subscale for the intervention group||||<.001
71688029|NCT04227405|142892362|SUPERIORITY||Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected decrease from pre-test to follow-up in the intervention group is not significantly (p \> .05) different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Emotional Abuse subscale||||<.10
71688030|NCT04227405|142892362|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship subscale for the control group||||>.05
71688031|NCT04227405|142892362|SUPERIORITY||Slope|0.29|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Satisfaction subscale for the intervention group||||<.001
71881256|NCT03357731|143281695|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.392||0.503|TWO_SIDED|95.0|-1.085|0.55|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|E/e' ratio||0.550|-1.085|0.503
71881257|NCT03357731|143281696|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.398||0.994|TWO_SIDED|95.0|-0.827|0.82|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||0.820|-0.827|0.994
71881258|NCT03357731|143281696|SUPERIORITY||Mean Difference (Net)|0.48|STANDARD_ERROR_OF_MEAN|0.258||0.073|TWO_SIDED|95.0|-0.049|1.013|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|annular e' velocity||1.013|-0.049|0.073
71881259|NCT03357731|143281697|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.4||0.705|TWO_SIDED|95.0|-0.67|0.976|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.976|-0.670|0.705
71688032|NCT04227405|142892362|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Satisfaction subscale||||<.001
71688033|NCT04227405|142892362|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
71688034|NCT04227405|142892362|SUPERIORITY||Slope|0.24|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Relationship Commitment subscale for the intervention group||||<.001
71688035|NCT04227405|142892362|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Relationship Commitment subscale||||<.001
71688036|NCT04227405|142892362|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for the control group||||>.05
71688037|NCT04227405|142892362|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Positive Conflict Management subscale for th eintervention group||||>.05
71688038|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
71688039|NCT04227405|142892362|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the control group||||>.05
71688040|NCT04227405|142892362|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Negative Conflict Management subscale for the intervention group||||>.05
71688041|NCT04227405|142892362|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.14|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Negative Conflict Management subscale||||>.05
71688042|NCT04227405|142892362|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the control group||||>.05
71688043|NCT04227405|142892362|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Quality subscale for the intervention group||||>.05
71881260|NCT03357731|143281697|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.404||0.105|TWO_SIDED|95.0|-1.504|0.151|||Kenward-Roger degree of freedom|Kenward-Roger degree of freedom is used to adjust the standard error of treatment effect|The modelled mean difference uses treatment sequence and difference of baselines as a covariates of the treatment effect.|||0.151|-1.504|0.105
71881261|NCT02495844|143281706|SUPERIORITY||Odds Ratio (OR)|4.14|||=|0.0679|TWO_SIDED|95.0|0.9|19.06|||Regression, Logistic|||||19.06|0.90|=0.0679
71688044|NCT04227405|142892362|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Quality subscale||||>.05
71688045|NCT04227405|142892362|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group||||>.05
71688046|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Emotional Abuse subscale for the intervention group||||>.05
71688047|NCT04227405|142892362|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Emotional Abuse subscale||||>.05
71688048|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.01|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the control group||||>.05
71688049|NCT04227405|142892362|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Satisfaction subscale for the interventionn group||||>.05
71688050|NCT04227405|142892362|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship satisfaction subscale||||>.05
71688051|NCT04227405|142892362|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from post-test to Follow-up in the Relationship Commitment subscale for the control group||||>.05
71688052|NCT04227405|142892362|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Relationship Commitment subscale for the intervention group||||>.05
71881262|NCT03118232|143281719|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|16.6|||<|0.001|TWO_SIDED|95.0|11.0|21.8|||Mixed Models Analysis|||||21.8|11.0|<0.001
71688053|NCT04227405|142892362|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Relationship Commitment subscale||||>.05
71688054|NCT04227405|142892362|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the control group||||>.05
71688055|NCT04227405|142892362|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in banking subscale for the intervention group||||>.05
71688056|NCT04227405|142892362|SUPERIORITY||Slope|0.07|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Banking subscale||||>.05
71881263|NCT03118232|143281720|OTHER|The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.|Difference in Risk Ratio|14.6|||<|0.001|TWO_SIDED|95.0|9.7|19.2|||Mixed Models Analysis|||||19.2|9.7|<0.001
71881264|NCT02325219|143281725|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71881265|NCT02325219|143281725|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71881266|NCT02325219|143281726|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71881267|NCT02325219|143281726|SUPERIORITY||||||<|0.001|||||||Fisher Exact|||||||< 0.001
71688057|NCT04227405|142892362|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.001
71881268|NCT02918864|143281772|SUPERIORITY||Beta Coefficient|-0.22||||0.037|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.037
71881269|NCT02918864|143281774|SUPERIORITY||Beta Coefficient|-0.23||||0.016|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.016
71881270|NCT02918864|143281776|SUPERIORITY||Beta Coefficient|-0.16||||0.061|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SB=Group+Time+Group\*Time+ADHD+ γ + ε; ADHD, CASI T-score significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.061
71881271|NCT02918864|143281778|SUPERIORITY||Beta Coefficient|0.03||||0.674|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.674
71881272|NCT02918864|143281780|SUPERIORITY||Beta Coefficient|0.09||||0.191|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.191
71920918|NCT01258738|143362971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0143|TWO_SIDED|95.0|-5.47|-0.61|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.61|-5.47|0.0143
71920919|NCT01258738|143362971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.0038|TWO_SIDED|95.0|-5.23|-1.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-1.02|-5.23|0.0038
71920920|NCT01258738|143362972|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test||||<0.001
71920921|NCT01258738|143362972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.0001|TWO_SIDED|95.0|-10.85|-4.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-4.58|-10.85|<0.0001
71920922|NCT01258738|143362972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.12|||<|0.0001|TWO_SIDED|95.0|-9.16|-3.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||-3.09|-9.16|<0.0001
71920923|NCT01258738|143362972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.78||||0.0009|TWO_SIDED|95.0|-9.15|-2.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-2.41|-9.15|0.0009
71920924|NCT01258738|143362972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.03|||<|0.0001|TWO_SIDED|95.0|-10.34|-3.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-3.73|-10.34|<0.0001
71920925|NCT01258738|143362973|SUPERIORITY_OR_OTHER|||||||0.037|||||||t-test, 2 sided|||With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were \<0.001, from paired t-test.||||0.0370
71920926|NCT01258738|143362973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.9965|TWO_SIDED|95.0|-4.39|4.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||4.37|-4.39|0.9965
71920927|NCT01258738|143362973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.61||||0.197|TWO_SIDED|95.0|-1.89|9.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||9.10|-1.89|0.1970
71920928|NCT01258738|143362973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.07||||0.0394|TWO_SIDED|95.0|0.3|11.84|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||11.84|0.30|0.0394
71920929|NCT01258738|143362974|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.01 at Week 12 and \<0.001 thereafter, from paired t-test.||||<0.01
71920930|NCT01258738|143362974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1341|TWO_SIDED|95.0|-0.02|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4||0.21|-0.02|0.1341
71920931|NCT01258738|143362974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.0447|TWO_SIDED|95.0|0.0|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8||0.14|0.00|0.0447
71920932|NCT01258738|143362974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.1345|TWO_SIDED|95.0|-0.02|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12||0.13|-0.02|0.1345
71920933|NCT01258738|143362975|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71881273|NCT02918864|143281782|SUPERIORITY||Beta Coefficient|0.04||||0.599|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SC=Group+Time+Group\*Time+Group\*VIQ+ γ + ε; VIQ, verbal intelligence quotient (VIQ) significant moderator), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||H0=No significant interaction of Group\*Time||||0.599
71881274|NCT02918864|143281784|SUPERIORITY|||||||0.462||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 12"||||0.462
71881275|NCT02918864|143281785|SUPERIORITY|||||||1||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 16"||||1.000
71920934|NCT01258738|143362975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.31||||0.1035|TWO_SIDED|95.0|-0.27|2.9|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||2.90|-0.27|0.1035
71920935|NCT01258738|143362975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38||||0.0134|TWO_SIDED|95.0|0.5|4.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||4.26|0.50|0.0134
71688058|NCT04227405|142892362|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the intervention group||||<.001
71920936|NCT01258738|143362976|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
71920937|NCT01258738|143362976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.252|TWO_SIDED|95.0|-0.84|3.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||3.19|-0.84|0.2520
71881276|NCT02918864|143281786|SUPERIORITY|||||||0.607||||||2-sided p-value; p-value reported not adjusted for multiple tests (with different time points)|Fisher Exact|||"Ho=Group and response are independent (responders=improved scores of 1-2; non-responders=worsened scores of 5-7 on the CGI-I) at week 24"||||0.607
71920938|NCT01258738|143362976|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.4981|TWO_SIDED|95.0|-1.63|3.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||3.34|-1.63|0.4981
71920939|NCT01258738|143362977|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71881277|NCT02918864|143281787|SUPERIORITY||Beta Coefficient|-0.15||||0.31|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.310
71881278|NCT02918864|143281789|SUPERIORITY||Beta Coefficient|-0.2||||0.115|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.115
71881279|NCT02918864|143281791|SUPERIORITY||Beta Coefficient|-0.08||||0.455|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (SRS=Group+Time+Group\*Time+VIQ+ γ + ε; VIQ, verbal IQ significant covariate), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.455
71920940|NCT01258738|143362977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.4621|TWO_SIDED|95.0|-0.9|0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.41|-0.90|0.4621
71920941|NCT01258738|143362977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.3842|TWO_SIDED|95.0|-1.28|0.5|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.50|-1.28|0.3842
71920942|NCT01258738|143362978|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920943|NCT01258738|143362978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.6357|TWO_SIDED|95.0|-0.52|0.86|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.86|-0.52|0.6357
71920944|NCT01258738|143362978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2439|TWO_SIDED|95.0|-1.39|0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.36|-1.39|0.2439
71920945|NCT01258738|143362979|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71688059|NCT04227405|142892362|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.03|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Banking subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||<.10
71920946|NCT01258738|143362979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.3286|TWO_SIDED|95.0|-1.55|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||0.52|-1.55|0.3286
71920947|NCT01258738|143362980|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920948|NCT01258738|143362980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1829|TWO_SIDED|95.0|-1.93|0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.||0.37|-1.93|0.1829
71920949|NCT01258738|143362981|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.05, from paired t-test.||||<0.05
71920950|NCT01258738|143362981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.37||||0.5226|TWO_SIDED|95.0|-4.95|9.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||9.68|-4.95|0.5226
71920951|NCT01258738|143362981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.6232|TWO_SIDED|95.0|-4.9|8.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||8.14|-4.90|0.6232
71920952|NCT01258738|143362981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.52||||0.3877|TWO_SIDED|95.0|-4.53|11.57|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||11.57|-4.53|0.3877
71920953|NCT01258738|143362981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.74||||0.2402|TWO_SIDED|95.0|-3.22|12.69|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||12.69|-3.22|0.2402
71920954|NCT01258738|143362982|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and thereafter, from paired t-test.||||<0.001
71920955|NCT01258738|143362982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.19||||0.0193|TWO_SIDED|95.0|-16.85|-1.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-1.52|-16.85|0.0193
71920956|NCT01258738|143362982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.08||||0.173|TWO_SIDED|95.0|-12.41|2.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.26|-12.41|0.1730
71920957|NCT01258738|143362982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.26||||0.1224|TWO_SIDED|95.0|-14.23|1.71|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||1.71|-14.23|0.1224
71920958|NCT01258738|143362982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.14||||0.0461|TWO_SIDED|95.0|-18.11|-0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.16|-18.11|0.0461
71920959|NCT01258738|143362983|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920960|NCT01258738|143362983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97||||0.0372|TWO_SIDED|95.0|-11.58|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.36|-11.58|0.0372
71920961|NCT01258738|143362983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1||||0.2126|TWO_SIDED|95.0|-7.98|1.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||1.79|-7.98|0.2126
71920962|NCT01258738|143362983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.66||||0.033|TWO_SIDED|95.0|-12.79|-0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||-0.54|-12.79|0.0330
71920963|NCT01258738|143362983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.85||||0.0397|TWO_SIDED|95.0|-13.38|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||-0.33|-13.38|0.0397
71920964|NCT01258738|143362984|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were \<0.001 at Week 16 and at Week 32 and thereafter, from paired t test.||||<0.001
71920965|NCT01258738|143362984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.29||||0.0382|TWO_SIDED|95.0|-16.12|-0.46|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2||-0.46|-16.12|0.0382
71922481|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|7.0||||0.244|TWO_SIDED|95.0|-4.2|18.3|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||18.3|-4.2|0.244
71920966|NCT01258738|143362984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.1648|TWO_SIDED|95.0|-12.69|2.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4||2.19|-12.69|0.1648
71688060|NCT04227405|142892362|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulty to Pay Bills for the control group||||>.05
71920967|NCT01258738|143362984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.98||||0.1476|TWO_SIDED|95.0|-14.11|2.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8||2.15|-14.11|0.1476
71920968|NCT01258738|143362984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.68||||0.0687|TWO_SIDED|95.0|-18.03|0.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12||0.68|-18.03|0.0687
71920969|NCT01258738|143362985|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920970|NCT01258738|143362985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2578|TWO_SIDED|95.0|-1.21|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||0.33|-1.21|0.2578
71920971|NCT01258738|143362985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.4334|TWO_SIDED|95.0|-1.21|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||0.52|-1.21|0.4334
71920972|NCT01258738|143362986|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were \<0.001, from paired t-test.||||<0.001
71920973|NCT01258738|143362986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.3554|TWO_SIDED|95.0|-4.7|1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4||1.70|-4.70|0.3554
71920974|NCT01258738|143362986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.335|TWO_SIDED|95.0|-5.82|1.99|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12||1.99|-5.82|0.3350
71920975|NCT01258738|143362987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.41||||14.41|TWO_SIDED|95.0|0.04|28.78|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||28.78|0.04|14.41
71920976|NCT01258738|143362988|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.03||||0.1285|TWO_SIDED|95.0|-2.51|24.56|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.||24.56|-2.51|0.1285
71920977|NCT00568399|143362991|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.2|STANDARD_DEVIATION|0.987||0.001|TWO_SIDED|95.0||||Coronary calcium score after treatment compared to baseline|Wilcoxon (Mann-Whitney)|||This was a pilot study without a control group. There were no power calculations (see manuscript).||||0.001
71920978|NCT00783263|143363016|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.25|||<|0.001|TWO_SIDED|95.0|-19.89|-10.6|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.||||-10.60|-19.89|<0.001
71920979|NCT00783263|143363017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.31|||<|0.001|TWO_SIDED|95.0|-18.95|-5.67|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-5.67|-18.95|<0.001
71920980|NCT00783263|143363017|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.46|||<|0.001|TWO_SIDED|95.0|-23.92|-10.99|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.||||-10.99|-23.92|<0.001
71920981|NCT00783263|143363018|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5|||<|0.001|TWO_SIDED|95.0|2.9|6.9|||Logistic Regression|Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: \<100, 100-\<130, ≥130 mg/dL).||||6.9|2.9|<0.001
71920982|NCT00783263|143363019|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.1|||<|0.001|TWO_SIDED|95.0|1.7|5.8|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||5.8|1.7|<0.001
71920983|NCT00783263|143363019|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|3.4|12.3|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: \<100, 100-\<130, \>=130 mg/dL).||||12.3|3.4|<0.001
71920984|NCT00783263|143363020|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.0|||<|0.001|TWO_SIDED|95.0|4.6|14.0|||Logistic Regression|||||14.0|4.6|<0.001
71920985|NCT00783263|143363021|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.1|||<|0.001|TWO_SIDED|95.0|2.2|11.8|||Logistic Regression|||Stratum I||11.8|2.2|<0.001
71920986|NCT00783263|143363021|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.4|||<|0.001|TWO_SIDED|95.0|5.2|24.8|||Logistic Regression|||Stratum II||24.8|5.2|<0.001
71920987|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.65|||<|0.001|TWO_SIDED|95.0|-11.59|-5.71|||Longitudinal Data Analysis|||Total Cholesterol (mg/dL)||-5.71|-11.59|<0.001
71920988|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.306|TWO_SIDED|95.0|-9.04|2.84|||Longitudinal Data Analysis|||Triglycerides (mg/dL)||2.84|-9.04|0.306
71881280|NCT02918864|143281793|SUPERIORITY||Beta Coefficient|-0.14||||0.379|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.379
71881281|NCT02918864|143281795|SUPERIORITY||Beta Coefficient|-0.14||||0.275|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||Ho=No significant interaction of Group\*Time||||0.275
71688061|NCT04227405|142892362|SUPERIORITY||Slope|-0.19|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||<.05
71881282|NCT02918864|143281797|SUPERIORITY||Beta Coefficient|-0.2||||0.087|TWO_SIDED|||||p-value reported for Group\*Time, primary comparison in linear mixed effects model (CGS=Group+Time+Group\*Time+ γ + ε), not adjusted for multiple tests (with different time points)|Mixed Models Analysis|||||||0.087
71881283|NCT02634151|143281806|SUPERIORITY||LS Mean Difference|-11.05||||0.0057|TWO_SIDED|95.0|-18.81|-3.29|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||A 2-sided test with a significance level of 0.05 was used for the comparison.||-3.29|-18.81|0.0057
71881284|NCT02634151|143281807|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.8||||0.0648|TWO_SIDED|95.0|-24.35|0.75|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||High-Intensity.||0.75|-24.35|0.0648
71881285|NCT02634151|143281807|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.64||||0.0398|TWO_SIDED|95.0|-20.77|-0.51|||ANCOVA|Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.||Moderate Intensity.||-0.51|-20.77|0.0398
71920989|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.15||||0.111|TWO_SIDED|95.0|-4.79|0.49|||Longitudinal Data Analysis|||High-Density Lipoprotein Cholesterol||0.49|-4.79|0.111
71920990|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.98|||<|0.001|TWO_SIDED|95.0|-16.1|-7.86|||Longitudinal Data Analysis|||Non High-Density Liproprotein Cholesterol||-7.86|-16.10|<0.001
71920991|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.25|||<|0.001|TWO_SIDED|95.0|-18.36|-8.13|||Longitudinal Data Analysis|||LDL Cholesterol/HDL Cholesterol||-8.13|-18.36|<0.001
71920992|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.45||||0.002|TWO_SIDED|95.0|-10.53|-2.36|||Longitudinal Data Analysis|||Total Cholesterol/HDL Cholesterol||-2.36|-10.53|0.002
71920993|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.52||||0.001|TWO_SIDED|95.0|-15.3|-3.75|||Longitudinal Data Analysis|||Non-HDL Cholestrol/HDL Cholesterol||-3.75|-15.30|0.001
71920994|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.41|||<|0.001|TWO_SIDED|95.0|-12.74|-6.08|||Longitudinal Data Analysis|||Apolipoprotein B (Apo B)||-6.08|-12.74|<0.001
71920995|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.82||||0.102|TWO_SIDED|95.0|-3.99|0.36|||Longitudinal Data Analysis|||Apolipoprotein A-I (Apo A-I)||0.36|-3.99|0.102
71920996|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.54|||<|0.001|TWO_SIDED|95.0|-11.25|-3.83|||Longitudinal Data Analysis|||Apolipoprotein B/Apo A-I||-3.83|-11.25|<0.001
71920997|NCT00783263|143363022|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.08||||0.861|TWO_SIDED|95.0|-13.13|10.97|||Longitudinal Data Analysis|||hs-C-Reactive Protein||10.97|-13.13|0.861
71920998|NCT00405756|143363023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.001|TWO_SIDED|95.0|0.278|0.56||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.560|0.278|<0.001
71920999|NCT00405756|143363023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|0.001|TWO_SIDED|95.0|0.347|0.702||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.702|0.347|<0.001
71921000|NCT00405756|143363023|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.134|TWO_SIDED|95.0|0.589|1.075||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.075|0.589|0.134
71921001|NCT00405756|143363024|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.214|0.541|||Log Rank|P-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.||||0.541|0.214|<0.001
71921002|NCT00405756|143363026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.337|||<|0.001|TWO_SIDED|95.0|0.231|0.493||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.493|0.231|<0.001
71921003|NCT00405756|143363026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.414|||<|0.001|TWO_SIDED|95.0|0.284|0.603||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||0.603|0.284|<0.001
71921004|NCT00405756|143363026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.826||||0.223|TWO_SIDED|95.0|0.606|1.125||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank|||||1.125|0.606|0.223
71921005|NCT00405756|143363027|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||<0.001
71921006|NCT00405756|143363027|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.009
71921007|NCT00405756|143363027|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)|||||||0.003
71921008|NCT00405756|143363027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.04|5.47|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||5.47|2.04|<0.001
71688062|NCT04227405|142892362|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Difficulties to pay bills subscale||||>.05
71921009|NCT00405756|143363027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58||||0.096|TWO_SIDED|95.0|0.95|2.62|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||2.62|0.95|0.096
71921010|NCT00405756|143363027|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.12||||0.002|TWO_SIDED|95.0|1.33|3.37|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE||3.37|1.33|0.002
71688063|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulty to Pay Bills subscale for the control group||||>.05
71688064|NCT04227405|142892362|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Difficulties to Pay Bills subscale for the intervention group||||>.05
71688065|NCT04227405|142892362|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Difficulty to Pay Bills subscale||||>.05
71688066|NCT04227405|142892362|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|||||No adjustment to p vallue|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the control group||||<.001
71688067|NCT04227405|142892362|SUPERIORITY||Slope|-0.72|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in depression subscale for the intervention group||||<.001
71688068|NCT04227405|142892362|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Depression subscale||||>.05
71688069|NCT04227405|142892362|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the control group||||>.05
71688070|NCT04227405|142892362|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in depression subscale for the intervention group||||>.05
71688071|NCT04227405|142892362|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in depression subscale||||>.05
71688072|NCT04227405|142892362|SUPERIORITY||Slope|-0.29|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to follow-up in the Anxiety subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
71688073|NCT04227405|142892362|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Anxiety subscale for the intervention group||||<.05
71881286|NCT02634151|143281808|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.09||||0.0275|TWO_SIDED|95.0|-19.04|-1.14|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.14|-19.04|0.0275
71881287|NCT02634151|143281808|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.4||||0.0524|TWO_SIDED|95.0|-18.9|0.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4.||0.10|-18.90|0.0524
71688074|NCT04227405|142892362|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.32|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Anxiety subscale||||>.05
71688075|NCT04227405|142892362|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
71688076|NCT04227405|142892362|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in anxiety subscale for the control group||||>.05
71688077|NCT04227405|142892362|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the Anxiety subscale||||>.05
71688078|NCT04227405|142892362|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the control group||||>.05
71688079|NCT04227405|142892362|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.1|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in parenting stress subscale for the intervention group||||>.05
71688080|NCT04227405|142892362|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in parenting stress subscale|Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|||>.05
71688081|NCT04227405|142892362|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.03|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in banking subscale for the control group||||<.05
71688082|NCT04227405|142892362|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in parenting stress subscale for the control group||||>.05
71688083|NCT04227405|142892362|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in Parenting Stress subscale||||>.05
71688084|NCT04227405|142892362|SUPERIORITY||Slope|0.26|STANDARD_ERROR_OF_MEAN|0.13|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Partner subscale for the control group||||<.10
71688085|NCT04227405|142892362|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Time with Parter subscale for the intervention group||||>.05
71688086|NCT04227405|142892362|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.2|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn Time with Partner subscale||||>.05
71688087|NCT04227405|142892362|SUPERIORITY||Slope|-0.14|STANDARD_ERROR_OF_MEAN|0.04|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the control group||||<.001
71688088|NCT04227405|142892362|SUPERIORITY||Slope|0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Time with Partner subscale for the intervention group||||>.05
71688089|NCT04227405|142892362|SUPERIORITY||Slope|0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Time with Partner subscale|Changes from post-test to follow-up in the intervention group were significantly different from the change from post-test to follow-up in the control group|||<.001
71688090|NCT04227405|142892362|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.05|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.05
71688091|NCT04227405|142892362|SUPERIORITY||Slope|0.32|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Conflict Management Satisfaction subscale for the control group||||<.001
71921011|NCT00405756|143363029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.348|||<|0.001|TWO_SIDED|95.0|0.228|0.531||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.531|0.228|<0.001
71921012|NCT00405756|143363029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.419|||<|0.001|TWO_SIDED|95.0|0.281|0.623||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.623|0.281|<0.001
71921013|NCT00405756|143363029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.825||||0.302|TWO_SIDED|95.0|0.571|1.191||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.191|0.571|0.302
71688092|NCT04227405|142892362|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.08|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up in Conflict Management Satisfaction subscale||||<.05
71688093|NCT04227405|142892362|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in Conflict Management Satisfaction subscale for the control group||||>.05
71688094|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in conflict management satisfaction subscale for the intervention group||||>.05
71688095|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Difference between the control and the intervention group in the change from post-test to follow-up in Conflict Management Satisfaction subscale|Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|||>.05
71688096|NCT04227405|142892362|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.05|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in budgeting subscale for the control group||||<.10
71688097|NCT04227405|142892362|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.06|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in Budgeting subscale for the intervention group||||<.05
71688098|NCT04227405|142892362|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.07|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.01
71688099|NCT04227405|142892362|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the control group||||<.001
71688100|NCT04227405|142892362|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up in budgeting subscale for the intervention group||||<.001
71688101|NCT04227405|142892362|SUPERIORITY||Slope|-0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from pre-test to follow-up in Budgeting subscale|Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|||<.001
71688102|NCT04227405|142892364|SUPERIORITY||Slope|-0.35|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
71688103|NCT04227405|142892364|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Acceptance subscale for the intervention group||||<.05
71688104|NCT04227405|142892364|SUPERIORITY||Slope|0.68|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
71688105|NCT04227405|142892364|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||<.05
71688106|NCT04227405|142892364|SUPERIORITY||Slope|0.38|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.05
71688107|NCT04227405|142892364|SUPERIORITY||Slope|0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale|The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|||<.001
71688108|NCT04227405|142892364|SUPERIORITY||Slope|-0.32|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
71688109|NCT04227405|142892364|SUPERIORITY||Slope|0.44|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the intervention group||||<.01
71688110|NCT04227405|142892364|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
71688111|NCT04227405|142892364|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
71688112|NCT04227405|142892364|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||>.05
71688113|NCT04227405|142892364|SUPERIORITY||Slope|0.12|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||>.05
71881288|NCT02634151|143281808|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.89||||0.8602|TWO_SIDED|95.0|-9.12|10.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||10.90|-9.12|0.8602
71881289|NCT02634151|143281808|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.63||||0.0115|TWO_SIDED|95.0|-22.37|-2.89|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-2.89|-22.37|0.0115
71921014|NCT00405756|143363030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.404|||<|0.001|TWO_SIDED|95.0|0.296|0.553||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.553|0.296|<0.001
71688114|NCT04227405|142892365|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.14|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||<.10
71688115|NCT04227405|142892365|SUPERIORITY||Slope|0.41|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.05
71688116|NCT04227405|142892365|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Aceptance subscale||||<.001
71688117|NCT04227405|142892365|SUPERIORITY||Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||<.10
71688118|NCT04227405|142892365|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.05
71688119|NCT04227405|142892365|SUPERIORITY||Slope|0.76|STANDARD_ERROR_OF_MEAN|0.22|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.01
71688120|NCT04227405|142892365|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
71688121|NCT04227405|142892365|SUPERIORITY||Slope|0.59|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
71688122|NCT04227405|142892365|SUPERIORITY||Slope|0.94|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.001
71688123|NCT04227405|142892365|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71881290|NCT02634151|143281808|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.87||||0.1945|TWO_SIDED|95.0|-14.79|3.05|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Average of week 8 and 12||3.05|-14.79|0.1945
71688124|NCT04227405|142892365|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the Intervention group||||>.05
71688125|NCT04227405|142892365|SUPERIORITY||Slope|0.13|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||>.05
71688126|NCT04227405|142892365|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
71688127|NCT04227405|142892365|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the intervention group||||>.05
71688128|NCT04227405|142892365|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Positive Conflict Management subscale||||>.05
71688129|NCT04227405|142892365|SUPERIORITY|Changes from post-test to Follow-up in the Active Coping subscale for the control group|Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|||||>.05
71688130|NCT04227405|142892365|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the intervention group||||>.05
71688131|NCT04227405|142892365|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Copinng subscale||||>.05
71688132|NCT04227405|142892365|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Plannning subscale for the control group||||>.05
71688133|NCT04227405|142892365|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||<.10
71881291|NCT02634151|143281809|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-5.88||||0.0991|TWO_SIDED|95.0|-12.89|1.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.13|-12.89|0.0991
71881292|NCT02634151|143281810|OTHER|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.58||||0.0101|TWO_SIDED|95.0|-13.32|-1.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.84|-13.32|0.0101
71881293|NCT02634151|143281810|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.56||||0.0037|TWO_SIDED|95.0|-15.94|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.18|-15.94|0.0037
71881294|NCT02634151|143281810|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.94||||0.7839|TWO_SIDED|95.0|-7.72|5.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.84|-7.72|0.7839
71881295|NCT02634151|143281810|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.69||||0.0025|TWO_SIDED|95.0|-17.53|-3.84|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.84|-17.53|0.0025
71921015|NCT00405756|143363030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.499|||<|0.001|TWO_SIDED|95.0|0.363|0.688||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||0.688|0.363|<0.001
71921016|NCT00405756|143363030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.827||||0.169|TWO_SIDED|95.0|0.63|1.085||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank|||||1.085|0.630|0.169
71921017|NCT00089505|143363056|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.69|||<|0.001|TWO_SIDED|95.0|1.79|7.61||P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Regression, Cox|The model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm\^3).|The HR is for NVP/NVP vs. NVP/LPV\_r.|||7.61|1.79|<0.001
71921018|NCT00089505|143363057|NON_INFERIORITY_OR_EQUIVALENCE|NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV\_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.|Hazard Ratio (HR)|0.85||||0.43|TWO_SIDED|95.0|0.56|1.29||P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.|Regression, Cox|The cox proportional hazard model was stratified by screening CD4 strata (\<50 vs. \>=50 cells/mm3).|The HR is for NoNVP/NVP vs. NoNVP/LPV\_r.|||1.29|0.56|0.43
71921019|NCT01117428|143363061|EQUIVALENCE|Differences between Parts E and F in terms of Best Overall Response evaluated from screening until disease progression.||||||0.6645||||||No adjustment, 5% significance level|Fisher Exact|||||||0.6645
71921020|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.8|-1.4|<0.0001
71921021|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.2|-1.7|<0.0001
71921022|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.7|||<|0.0001|TWO_SIDED|95.0|-2.0|-1.4||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.4|-2.0|<0.0001
71921023|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|0.3||||0.0799|TWO_SIDED|95.0|0.0|0.6||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.6|-0.0|0.0799
71921024|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.1||||0.3942|TWO_SIDED|95.0|-0.4|0.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||0.2|-0.4|0.3942
71921025|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.3||||0.0272|TWO_SIDED|95.0|-0.6|0.0||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurement||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.0|-0.6|0.0272
71921026|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.5|-1.1|<0.0001
71921027|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.5|<0.0001
71921028|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-1.1|-1.7|<0.0001
71921029|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|0.2||||0.1958|TWO_SIDED|95.0|-0.1|0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.5|-0.1|0.1958
71922482|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.2||||0.979|TWO_SIDED|95.0|-15.0|14.6|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.6|-15.0|0.979
71922483|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-9.8||||0.166|TWO_SIDED|95.0|-21.8|2.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||2.2|-21.8|0.166
71921030|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.2||||0.1868|TWO_SIDED|95.0|-0.5|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.1|-0.5|0.1868
71921031|NCT03018028|143363064|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4||||0.0077|TWO_SIDED|95.0|-0.7|-0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.1|-0.7|0.0077
71922484|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.5||||0.947|TWO_SIDED|95.0|-13.2|14.2|||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||14.2|-13.2|0.947
71881296|NCT02634151|143281811|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.66||||0.0117|TWO_SIDED|95.0|-22.45|-2.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.88|-22.45|0.0117
71881297|NCT02634151|143281811|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.55||||0.0036|TWO_SIDED|95.0|-25.88|-5.21|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.21|-25.88|0.0036
71881298|NCT02634151|143281811|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.59||||0.9147|TWO_SIDED|95.0|-11.48|10.31||Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.|ANCOVA|||Week 8||10.31|-11.48|0.9147
71881299|NCT02634151|143281811|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.59||||0.0026|TWO_SIDED|95.0|-27.24|-5.93|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.93|-27.24|0.0026
71881300|NCT02634151|143281812|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.13||||0.0101|TWO_SIDED|95.0|-10.77|-1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.50|-10.77|0.0101
71881301|NCT02634151|143281812|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.73||||0.0036|TWO_SIDED|95.0|-12.89|-2.58|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-2.58|-12.89|0.0036
71881302|NCT02634151|143281812|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.12||||0.9653|TWO_SIDED|95.0|-5.27|5.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||5.51|-5.27|0.9653
71881303|NCT02634151|143281812|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.89||||0.0101|TWO_SIDED|95.0|-12.1|-1.68|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.68|-12.10|0.0101
71881304|NCT02634151|143281813|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.74||||0.0173|TWO_SIDED|95.0|-23.19|-2.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-2.30|-23.19|0.0173
71881305|NCT02634151|143281813|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-16.29||||0.0038|TWO_SIDED|95.0|-27.17|-5.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-5.40|-27.17|0.0038
71881306|NCT02634151|143281813|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.58||||0.7846|TWO_SIDED|95.0|-9.85|13.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||13.01|-9.85|0.7846
71881307|NCT02634151|143281813|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.98||||0.0121|TWO_SIDED|95.0|-24.83|-3.13|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-3.13|-24.83|0.0121
71922485|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|8.3||||0.286|TWO_SIDED|95.0|-7.1|23.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||23.8|-7.1|0.286
71921032|NCT03018028|143363091|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.2579|TWO_SIDED|95.0|0.29|1.4||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.40|0.29|0.2579
71921033|NCT03018028|143363091|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.25||||0.0052|TWO_SIDED|95.0|0.1|0.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.66|0.10|0.0052
71921034|NCT03018028|143363091|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31||||0.0259|TWO_SIDED|95.0|0.11|0.87||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.87|0.11|0.0259
71921035|NCT03018028|143363091|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.7||||0.0674|TWO_SIDED|95.0|0.93|7.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||7.80|0.93|0.0674
71921036|NCT03018028|143363091|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.07||||0.9087|TWO_SIDED|95.0|0.32|3.54||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||3.54|0.32|0.9087
71921037|NCT03018028|143363091|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33||||0.6498|TWO_SIDED|95.0|0.38|4.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||4.62|0.38|0.6498
71921038|NCT03018028|143363092|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.34||||0.0219|TWO_SIDED|95.0|0.14|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.86|0.14|0.0219
71921039|NCT03018028|143363092|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15||||0.0005|TWO_SIDED|95.0|0.05|0.44||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.44|0.05|0.0005
71921040|NCT03018028|143363092|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.23||||0.0098|TWO_SIDED|95.0|0.07|0.7||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.70|0.07|0.0098
71921041|NCT03018028|143363092|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.95||||0.1193|TWO_SIDED|95.0|0.76|11.46||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||11.46|0.76|0.1193
71921042|NCT03018028|143363092|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.31||||0.7147|TWO_SIDED|95.0|0.31|5.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||5.56|0.31|0.7147
71688134|NCT04227405|142892365|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Planning subscale||||>.05
71688135|NCT04227405|142892365|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71688136|NCT04227405|142892365|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||>.05
71688137|NCT04227405|142892365|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Support subscale||||>.05
71688138|NCT04227405|142892367|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to Follow-up in the Emotional Abuse subscale for the control group|Changes from pre-test to posttest in the Acceptance subscale for the control group||||<.05
71688139|NCT04227405|142892367|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Emotional Abuse subscale for the control group||||<.01
71881308|NCT02634151|143281814|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-13.32||||0.0108|TWO_SIDED|95.0|-23.32|-3.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-3.12|-23.32|0.0108
71688140|NCT04227405|142892367|SUPERIORITY||Slope|0.77|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Acceptance subscale||||<.001
71688141|NCT04227405|142892367|SUPERIORITY||Slope|-0.17|STANDARD_ERROR_OF_MEAN|0.13|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the control group||||>.05
71688142|NCT04227405|142892367|SUPERIORITY||Slope|0.3|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Active Coping subscale for the intervention group||||<.10
71688143|NCT04227405|142892367|SUPERIORITY||Slope|0.47|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Active Coping subscale||||<.05
71881309|NCT02634151|143281814|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.6|||<|0.0001|TWO_SIDED|95.0|-34.78|-12.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.42|-34.78|<0.0001
71688144|NCT04227405|142892367|SUPERIORITY||Slope|-0.38|STANDARD_ERROR_OF_MEAN|0.12|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the control group||||<.05
71688145|NCT04227405|142892367|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Planning subscale for the Intervention group||||<.05
71881310|NCT02634151|143281814|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.71||||0.1376|TWO_SIDED|95.0|-15.6|2.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.18|-15.60|0.1376
71881311|NCT02634151|143281814|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.64||||0.0144|TWO_SIDED|95.0|-28.1|-3.18|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||-3.18|-28.10|0.0144
71881312|NCT02634151|143281815|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-19.53||||0.0113|TWO_SIDED|95.0|-34.55|-4.51|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-4.51|-34.55|0.0113
71688146|NCT04227405|142892367|SUPERIORITY||Slope|0.74|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Planning subscale||||<.001
71688147|NCT04227405|142892367|SUPERIORITY||Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the control group||||>.05
71688148|NCT04227405|142892367|SUPERIORITY||Slope|0.49|STANDARD_ERROR_OF_MEAN|0.16|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest in the Instrumental Support subscale for the intervention group||||<.01
71688149|NCT04227405|142892367|SUPERIORITY||Slope|0.6|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to post-test in the intervention group is significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in the Instrumental Support subscale||||<.01
71688150|NCT04227405|142892368|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.15|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the control group||||>.05
71688151|NCT04227405|142892368|SUPERIORITY||Slope|0.52|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Acceptance subscale for the intervention group||||<.01
71688152|NCT04227405|142892368|SUPERIORITY||Slope|0.78|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Acceptance subscale|The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|||<.01
71688153|NCT04227405|142892368|SUPERIORITY||Slope|0.09|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the control group||||>.05
71688154|NCT04227405|142892368|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.2|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Active Coping subscale for the intervention group||||<.10
71688155|NCT04227405|142892368|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.25|<|0.1|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Active Coping subscale||||<.10
71688156|NCT04227405|142892368|SUPERIORITY||Slope|-0.31|STANDARD_ERROR_OF_MEAN|0.15|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the control group||||<.10
71688157|NCT04227405|142892368|SUPERIORITY||Slope|0.4|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Planning subscale for the intervention group||||<.05
71688158|NCT04227405|142892368|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Planning subscale||||<.01
71688159|NCT04227405|142892368|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.16|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71688160|NCT04227405|142892368|SUPERIORITY||Slope|0.64|STANDARD_ERROR_OF_MEAN|0.19|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.01
71688161|NCT04227405|142892368|SUPERIORITY||Slope|0.66|STANDARD_ERROR_OF_MEAN|0.24|<|0.01|TWO_SIDED||||||Multilevel modeling||The expected increase from pre-test to follow-up in the intervention group is significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up in the Instrumental Support subscale||||<.01
71688162|NCT04227405|142892368|SUPERIORITY||Slope|-0.05|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the control group||||>.05
71688163|NCT04227405|142892368|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Acceptance subscale for the interventionn group||||>.05
71688164|NCT04227405|142892368|SUPERIORITY||Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Acceptance subscale||||>.05
71688165|NCT04227405|142892368|SUPERIORITY||Slope|-0.08|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping subscale for the control group||||>.05
71688166|NCT04227405|142892368|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Active Coping in the intervention group||||>.05
71688167|NCT04227405|142892368|SUPERIORITY||Slope|0.01|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Active Coping subscale||||>.05
71688168|NCT04227405|142892368|SUPERIORITY||Slope|-0.07|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the control group||||>.05
71688169|NCT04227405|142892368|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Planning subscale for the intervention group||||>.05
71688170|NCT04227405|142892368|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.07|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in Planning subscale||||>.05
71881313|NCT02634151|143281815|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-33.64||||0.0002|TWO_SIDED|95.0|-50.58|-16.69|||ANCOVA|||Week 4||-16.69|-50.58|0.0002
71881314|NCT02634151|143281815|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-8.33||||0.1873|TWO_SIDED|95.0|-20.77|4.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.12|-20.77|0.1873
71881315|NCT02634151|143281815|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-29.58||||0.0172|TWO_SIDED|95.0|-53.8|-5.37|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-5.37|-53.80|0.0172
71881316|NCT02634151|143281816|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.52||||0.021|TWO_SIDED|95.0|-21.27|-1.77|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-1.77|-21.27|0.0210
71881317|NCT02634151|143281816|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-23.01|||<|0.0001|TWO_SIDED|95.0|-34.02|-12.01|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-12.01|-34.02|<0.0001
71881318|NCT02634151|143281816|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.43||||0.1483|TWO_SIDED|95.0|-15.19|2.33|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.33|-15.19|0.1483
71881319|NCT02634151|143281816|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.63||||0.0214|TWO_SIDED|95.0|-21.5|-1.76|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-1.76|-21.50|0.0214
71881320|NCT02634151|143281817|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.95||||0.0308|TWO_SIDED|95.0|-5.62|-0.28|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||-0.28|-5.62|0.0308
71881321|NCT02634151|143281817|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.3||||0.0002|TWO_SIDED|95.0|-9.56|-3.04|||ANCOVA|A 2-sided test with a significance level of 0.05 was used for the comparison.||Week 4||-3.04|-9.56|0.0002
71881322|NCT02634151|143281817|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.58||||0.2056|TWO_SIDED|95.0|-4.03|0.88|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.88|-4.03|0.2056
71881323|NCT02634151|143281817|SUPERIORITY||LS Mean Difference|-4.0||||0.0103|TWO_SIDED|95.0|-7.04|-0.96|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.96|-7.04|0.0103
71881324|NCT02634151|143281818|SUPERIORITY||LS Mean Difference|-2.13||||0.3193|TWO_SIDED|95.0|-6.36|2.09|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||2.09|-6.36|0.3193
71881325|NCT02634151|143281818|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-2.4||||0.2932|TWO_SIDED|95.0|-6.91|2.11|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.11|-6.91|0.2932
71881326|NCT02634151|143281818|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.98||||0.4383|TWO_SIDED|95.0|-3.06|7.02|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.02|-3.06|0.4383
71881327|NCT02634151|143281818|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|2.78||||0.2814|TWO_SIDED|95.0|-2.31|7.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.86|-2.31|0.2814
71881328|NCT02634151|143281819|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.92||||0.4278|TWO_SIDED|95.0|-3.23|1.38|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 2||1.38|-3.23|0.4278
71881329|NCT02634151|143281819|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.13||||0.3529|TWO_SIDED|95.0|-3.53|1.27|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.27|-3.53|0.3529
71881330|NCT02634151|143281819|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.24||||0.3522|TWO_SIDED|95.0|-1.39|3.86|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.86|-1.39|0.3522
71921043|NCT03018028|143363092|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.97||||0.3765|TWO_SIDED|95.0|0.44|8.85||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||8.85|0.44|0.3765
71921044|NCT02532998|143363114|SUPERIORITY_OR_OTHER||Treatment differences|-1.258|||||TWO_SIDED|90.0|-1.721|0.7945|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment C and Treatment D.||0.7945|-1.721|
71921045|NCT02532998|143363129|SUPERIORITY_OR_OTHER||Treatment differences|3.409|||||TWO_SIDED|90.0|2.946|3.872|||mixed linear model|Analyses done using mixed linear model involving fixed effect, random effect, and a covariate.||Statistical analysis of urinary sodium/potassium ratio between Treatment A and Treatment B.||3.872|2.946|
71921046|NCT02519777|143363141|SUPERIORITY|||||||0.6|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.60
71921047|NCT02519777|143363141|SUPERIORITY|||||||0.33|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.33
71921048|NCT02519777|143363141|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 48 from baseline||||0.61
71921049|NCT02519777|143363143|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.61
71921050|NCT02519777|143363143|SUPERIORITY|||||||0.72|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.72
71921051|NCT02519777|143363143|SUPERIORITY|||||||0.79|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.79
71921052|NCT02519777|143363143|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.55
71921053|NCT02519777|143363143|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.47
71921054|NCT02519777|143363143|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.95
71921055|NCT02519777|143363143|SUPERIORITY|||||||0.85|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 24 from baseline||||0.85
71921056|NCT02519777|143363143|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 72 from baseline||||0.67
71921057|NCT02519777|143363143|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in normalized composite neurocognitive test scores at Week 96 from baseline||||0.70
71921058|NCT02519777|143363144|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 24 from baseline||||0.99
71921059|NCT02519777|143363144|SUPERIORITY|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 48 from baseline||||0.97
71921060|NCT02519777|143363144|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 72 from baseline||||0.79
71921061|NCT02519777|143363144|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in functional status scores at Week 96 from baseline||||0.99
71921062|NCT02519777|143363144|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.74
71921063|NCT02519777|143363144|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.69
71921064|NCT02519777|143363144|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.44
71921065|NCT02519777|143363144|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
71921066|NCT02519777|143363144|SUPERIORITY|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 24 from baseline||||0.83
71688171|NCT04227405|142892368|SUPERIORITY||Slope|-0.09|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the control group||||>.05
71688172|NCT04227405|142892368|SUPERIORITY||Slope|-0.15|STANDARD_ERROR_OF_MEAN|0.06|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up in the Instrumental Support subscale for the intervention group||||<.10
71688173|NCT04227405|142892368|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.08|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up in the Instrumental Supportt subscale||||>.05
71688174|NCT04227405|142892370|SUPERIORITY||Slope|-1.41|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED||||||Multilevel modeling|||Changes from pre-test to posttest for the control group|A positive value indicates an increase while a negative value indicates a decrease|||<.05
71688175|NCT04227405|142892370|SUPERIORITY||Slope|2.02|STANDARD_ERROR_OF_MEAN|0.69|<|0.01|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to posttest for the intervention group||||<.01
71688176|NCT04227405|142892370|SUPERIORITY||Slope|-0.62|STANDARD_ERROR_OF_MEAN|0.83|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to post-test t in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
71688177|NCT04227405|142892371|SUPERIORITY||Slope|-1.48|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the control group||||>.05
71688178|NCT04227405|142892371|SUPERIORITY||Slope|-1.5|STANDARD_ERROR_OF_MEAN|0.82|<|0.1|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from pre-test to Follow-up for the intervention group||||<.10
71688179|NCT04227405|142892371|SUPERIORITY||Slope|-0.02|STANDARD_ERROR_OF_MEAN|1.01|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from Pre-test to Follow-up||||>.05
71688180|NCT04227405|142892371|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.02|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
71688181|NCT04227405|142892371|SUPERIORITY||Slope|-0.52|STANDARD_ERROR_OF_MEAN|0.23|>|0.05|TWO_SIDED||||||Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Changes from post-test to Follow-up for the control group||||>.05
71688182|NCT04227405|142892371|SUPERIORITY||Slope|-0.6|STANDARD_ERROR_OF_MEAN|0.03|>|0.05|TWO_SIDED||||||Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from Post-test to Follow-up||||>.05
71881331|NCT02634151|143281819|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.6||||0.2635|TWO_SIDED|95.0|-1.22|4.42|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.42|-1.22|0.2635
71688183|NCT04227405|142892373|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|1.16|>|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in Difficulties in Emotion Regulation for the control group||||>.05
71688184|NCT04227405|142892373|SUPERIORITY||Slope|-3.07|STANDARD_ERROR_OF_MEAN|1.51|<|0.05|TWO_SIDED|||||No adjustment for p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
71688185|NCT04227405|142892373|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.85|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||>.05
71688186|NCT04227405|142892374|SUPERIORITY||Slope|-0.7|STANDARD_ERROR_OF_MEAN|1.41|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling|||Change from pre-test to follow-up for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
71688187|NCT04227405|142892374|SUPERIORITY||Slope|-2.74|STANDARD_ERROR_OF_MEAN|1.79|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||>.05
71688188|NCT04227405|142892374|SUPERIORITY||Slope|-2.04|STANDARD_ERROR_OF_MEAN|2.24|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||>.05
71688189|NCT04227405|142892374|SUPERIORITY||Slope|0.36|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71688190|NCT04227405|142892374|SUPERIORITY||Slope|-0.33|STANDARD_ERROR_OF_MEAN|0.5|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71688191|NCT04227405|142892374|SUPERIORITY||Slope|-0.69|STANDARD_ERROR_OF_MEAN|0.68|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
71688192|NCT04227405|142892376|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological agggression subscale for the control group||||<.001
71881332|NCT02634151|143281820|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.23||||0.0464|TWO_SIDED|95.0|1.01|4.93|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.93|1.01|0.0464
71688193|NCT04227405|142892376|SUPERIORITY||Slope|-0.73|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in psychological aggression subscale for the intervention group||||<.001
71688194|NCT04227405|142892376|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.17|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Psychological Aggression subscale||||<.10
71881333|NCT02634151|143281820|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.3||||0.5278|TWO_SIDED|95.0|0.58|2.92|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.92|0.58|0.5278
71881334|NCT02634151|143281820|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.36||||0.0359|TWO_SIDED|95.0|1.06|5.27|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.27|1.06|0.0359
71881335|NCT02634151|143281821|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.5||||0.0268|TWO_SIDED|95.0|1.11|5.61|||Regression, Logistic|||Week 4||5.61|1.11|0.0268
71881336|NCT02634151|143281821|SUPERIORITY||Odds Ratio (OR)|1.55||||0.2755|TWO_SIDED|95.0|0.7|3.41|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.41|0.70|0.2755
71881337|NCT02634151|143281821|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|4.74||||0.0003|TWO_SIDED|95.0|2.05|10.94|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||10.94|2.05|0.0003
71881338|NCT02634151|143281822|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.26||||0.0079|TWO_SIDED|95.0|1.36|7.8|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||7.80|1.36|0.0079
71881339|NCT02634151|143281822|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.44||||0.4002|TWO_SIDED|95.0|0.62|3.35|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.35|0.62|0.4002
71881340|NCT02634151|143281822|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.09||||0.0142|TWO_SIDED|95.0|1.25|7.59|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.59|1.25|0.0142
71688195|NCT04227405|142892376|SUPERIORITY||Slope|0.0|STANDARD_ERROR_OF_MEAN|0.09|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling|||Change from pre-test to post-test in physical assault subscale for the control group|A positive value indicates an increase while a negative value indicates a decrease|||>.05
71881341|NCT02634151|143281823|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|3.7||||0.0115|TWO_SIDED|95.0|1.34|10.2|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||10.20|1.34|0.0115
71881342|NCT02634151|143281823|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|1.15||||0.7566|TWO_SIDED|95.0|0.48|2.75|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.75|0.48|0.7566
71881343|NCT02634151|143281823|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|Odds Ratio (OR)|2.96||||0.0298|TWO_SIDED|95.0|1.11|7.88|||Regression, Logistic|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||7.88|1.11|0.0298
71688196|NCT04227405|142892376|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test in the physical assault subscale for the intervention group||||<.001
71881344|NCT02634151|143281824|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.4||||0.0029|TWO_SIDED|95.0|-17.2|-3.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.7|-17.2|0.0029
71881345|NCT02634151|143281824|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-4.3||||0.1666|TWO_SIDED|95.0|-10.4|1.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.8|-10.4|0.1666
71881346|NCT02634151|143281824|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.5||||0.001|TWO_SIDED|95.0|-18.2|-4.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.8|-18.2|0.0010
71881347|NCT02634151|143281825|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-10.7||||0.0018|TWO_SIDED|95.0|-17.3|-4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-4.1|-17.3|0.0018
71881348|NCT02634151|143281825|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.8||||0.2437|TWO_SIDED|95.0|-10.1|2.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||2.6|-10.1|0.2437
71688197|NCT04227405|142892376|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.14|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Physical Assault subscale||||<.05
71921067|NCT02519777|143363144|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 48 from baseline||||0.80
71921068|NCT02519777|143363144|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 72 from baseline||||0.86
71921069|NCT02519777|143363144|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in functional status scores at Week 96 from baseline||||1.00
71921070|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|3.32|||||TWO_SIDED|95.0|-2.78|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-2.78|
71921071|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|5.17|||||TWO_SIDED|95.0|-0.53|10.87||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.87|-0.53|
71921072|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|-8.21|||||TWO_SIDED|95.0|-16.56|0.13||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||0.13|-16.56|
71921073|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|3.17|||||TWO_SIDED|95.0|-3.07|9.42||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||9.42|-3.07|
71921074|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|3.48|||||TWO_SIDED|95.0|-3.11|10.06||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||10.06|-3.11|
71921075|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|-1.85|||||TWO_SIDED|95.0|-7.89|4.19||||||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||4.19|-7.89|
71921076|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|-0.15|||||TWO_SIDED|95.0|-4.53|4.23||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24||4.23|-4.53|
71921077|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|-1.69|||||TWO_SIDED|95.0|-4.99|1.6||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48||1.60|-4.99|
71921078|NCT02519777|143363145|SUPERIORITY||Difference in Percentage of Participants|6.36|||||TWO_SIDED|95.0|-2.7|15.42||||||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in number of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96||15.42|-2.70|
71921079|NCT02519777|143363147|SUPERIORITY|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 24 from baseline||||0.67
71921080|NCT02519777|143363147|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 48 from baseline||||0.78
71921081|NCT02519777|143363147|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD4+ T-cell count at Week 96 from baseline||||0.94
71921082|NCT02519777|143363147|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.42
71921083|NCT02519777|143363147|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.07
71921084|NCT02519777|143363147|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.37
71921085|NCT02519777|143363147|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 24 from baseline||||0.08
71921086|NCT02519777|143363147|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 48 from baseline||||0.33
71921087|NCT02519777|143363147|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD4+ T-cell count at Week 96 from baseline||||0.56
71921088|NCT02519777|143363149|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 24 from baseline||||0.63
71921089|NCT02519777|143363149|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 48 from baseline||||0.38
71881349|NCT02634151|143281825|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-11.6||||0.0012|TWO_SIDED|95.0|-18.5|-4.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-4.7|-18.5|0.0012
71921090|NCT02519777|143363149|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in CD8+ T-cell count at Week 96 from baseline||||0.95
71921091|NCT02519777|143363149|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.27
71921092|NCT02519777|143363149|SUPERIORITY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.23
71921093|NCT02519777|143363149|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
71921094|NCT02519777|143363149|SUPERIORITY|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 24 from baseline||||0.03
71921095|NCT02519777|143363149|SUPERIORITY|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 48 from baseline||||0.02
71921096|NCT02519777|143363149|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in CD8+ T-cell count at Week 96 from baseline||||0.09
71921097|NCT02519777|143363150|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sCD14 in plasma at Week 48 from baseline||||1.00
71921098|NCT02519777|143363150|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.95
71921099|NCT02519777|143363150|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sCD14 in plasma at Week 48 from baseline||||0.96
71921100|NCT02519777|143363151|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||0.52
71921101|NCT02519777|143363151|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
71921102|NCT02519777|143363151|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in plasma at Week 48 from baseline||||<0.01
71921103|NCT02519777|143363152|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.91
71881350|NCT02634151|143281826|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.6832|TWO_SIDED|95.0|-4.2|2.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||2.8|-4.2|0.6832
71921104|NCT02519777|143363152|SUPERIORITY|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.86
71921105|NCT02519777|143363152|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 sTNFr-II in plasma at Week 48 from baseline||||0.94
71921106|NCT02519777|143363153|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 VCAM in plasma at Week 48 from baseline||||0.70
71921107|NCT02519777|143363153|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.28
71921108|NCT02519777|143363153|SUPERIORITY|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 VCAM in plasma at Week 48 from baseline||||0.85
71921109|NCT02519777|143363154|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.99
71921110|NCT02519777|143363154|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.26
71921111|NCT02519777|143363154|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 MIP-1 Beta in CSF at Week 48 from baseline||||0.20
71921112|NCT02519777|143363155|SUPERIORITY|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.59
71688198|NCT04227405|142892377|SUPERIORITY||Slope|-0.47|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the psychological aggression subscale for the control group||||<.001
71881351|NCT02634151|143281826|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.674|TWO_SIDED|95.0|-2.9|4.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||4.5|-2.9|0.6740
71881352|NCT02634151|143281826|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.3379|TWO_SIDED|95.0|-2.0|5.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||5.7|-2.0|0.3379
71881353|NCT02634151|143281827|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.7||||0.7753|TWO_SIDED|95.0|-5.9|4.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||4.4|-5.9|0.7753
71881354|NCT02634151|143281827|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.5472|TWO_SIDED|95.0|-3.9|7.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||7.4|-3.9|0.5472
71881355|NCT02634151|143281827|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|3.6||||0.2406|TWO_SIDED|95.0|-2.4|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.6|-2.4|0.2406
71688199|NCT04227405|142892377|SUPERIORITY||Slope|-0.77|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up in the Psychological Aggression subscale for the intervention group||||<.001
71881356|NCT02634151|143281828|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9028|TWO_SIDED|95.0|-3.3|3.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||3.8|-3.3|0.9028
71881357|NCT02634151|143281828|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|5.2||||0.0199|TWO_SIDED|95.0|0.8|9.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||9.6|0.8|0.0199
71881358|NCT02634151|143281828|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.6||||0.0369|TWO_SIDED|95.0|0.3|8.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||8.9|0.3|0.0369
71881359|NCT02634151|143281829|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.1||||0.911|TWO_SIDED|95.0|-1.2|1.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.4|-1.2|0.9110
71881360|NCT02634151|143281829|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.9||||0.0243|TWO_SIDED|95.0|0.3|3.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||3.5|0.3|0.0243
71688200|NCT04227405|142892377|SUPERIORITY||Slope|-0.3|STANDARD_ERROR_OF_MEAN|0.21|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up inn the psychological aggression subscale||||>.05
71688201|NCT04227405|142892377|SUPERIORITY||Slope|0.08|STANDARD_ERROR_OF_MEAN|0.04|<|0.1|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group in the psychological aggression subscale||||<.10
71688202|NCT04227405|142892377|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.05|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the psychological aggresssion subscale||||>.05
71688203|NCT04227405|142892377|SUPERIORITY||Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up in the psychological aggression subscale||||>.05
71688204|NCT04227405|142892377|SUPERIORITY||Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.12|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the physical assault subscale||||>.05
71688205|NCT04227405|142892377|SUPERIORITY||Slope|-0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Physical Assault Subscale||||<.05
71688206|NCT04227405|142892377|SUPERIORITY||Slope|-0.37|STANDARD_ERROR_OF_MEAN|0.18|<|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Physical Assault subscale||||<.05
71688207|NCT04227405|142892377|SUPERIORITY||Slope|0.02|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group for the Physical Assault subscale||||>.05
71688208|NCT04227405|142892377|SUPERIORITY||Slope|0.06|STANDARD_ERROR_OF_MEAN|0.04|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the intervention group for the Physical Assault subscale||||>.05
71688209|NCT04227405|142892377|SUPERIORITY||Slope|0.04|STANDARD_ERROR_OF_MEAN|0.06|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
71688210|NCT04227405|142892379|SUPERIORITY||Slope|-2.12|STANDARD_ERROR_OF_MEAN|0.57|<|0.001|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group||||<.001
71921113|NCT02519777|143363155|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.39
71921114|NCT02519777|143363155|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 IP-10 in CSF at Week 48 from baseline||||0.80
71688211|NCT04227405|142892379|SUPERIORITY||Slope|-4.46|STANDARD_ERROR_OF_MEAN|0.73|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.001
71688212|NCT04227405|142892379|SUPERIORITY||Slope|-2.34|STANDARD_ERROR_OF_MEAN|0.89|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to pos-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test in Time||||<.05
71688213|NCT04227405|142892380|SUPERIORITY||Slope|-1.96|STANDARD_ERROR_OF_MEAN|0.7|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group||||<.05
71688214|NCT04227405|142892380|SUPERIORITY||Slope|-4.48|STANDARD_ERROR_OF_MEAN|0.88|<|0.001|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group||||<.001
71688215|NCT04227405|142892380|SUPERIORITY||Slope|-2.52|STANDARD_ERROR_OF_MEAN|1.1|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up||||<.05
71688216|NCT04227405|142892380|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71688217|NCT04227405|142892380|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from post-test to follow-up for the control group||||>.05
71921115|NCT02519777|143363156|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.90
71688218|NCT04227405|142892380|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||No adjustment to p value|Multilevel modeling||Changes from post-test to follow-up in the intervention group were not significantly different from the change from post-test to follow-up in the control group|Difference between the control and the intervention group in the change from post-test to follow-up||||>.05
71881361|NCT02634151|143281829|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.0388|TWO_SIDED|95.0|0.1|3.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||3.2|0.1|0.0388
71881362|NCT02634151|143281830|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|7.0||||0.2799|TWO_SIDED|95.0|-5.7|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-5.7|0.2799
71881363|NCT02634151|143281830|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|26.8||||0.0018|TWO_SIDED|95.0|10.2|43.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||43.3|10.2|0.0018
71881364|NCT02634151|143281830|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|20.1||||0.0197|TWO_SIDED|95.0|3.3|36.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||36.9|3.3|0.0197
71881365|NCT02634151|143281831|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.6||||0.0179|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||1.0|0.1|0.0179
71881366|NCT02634151|143281831|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.1||||0.0003|TWO_SIDED|95.0|0.5|1.7|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||1.7|0.5|0.0003
71881367|NCT02634151|143281831|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.0095|TWO_SIDED|95.0|0.2|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||1.5|0.2|0.0095
71881368|NCT02634151|143281832|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-12.2||||0.0057|TWO_SIDED|95.0|-20.8|-3.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-3.6|-20.8|0.0057
71921116|NCT02519777|143363156|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.14
71921117|NCT02519777|143363156|SUPERIORITY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 Neopterin in CSF at Week 48 from baseline||||0.49
71881369|NCT02634151|143281832|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.2||||0.9665|TWO_SIDED|95.0|-8.3|8.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||8.6|-8.3|0.9665
71881370|NCT02634151|143281832|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-6.2||||0.2358|TWO_SIDED|95.0|-16.4|4.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||4.1|-16.4|0.2358
71881371|NCT02634151|143281833|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-1.3||||0.0048|TWO_SIDED|95.0|-2.3|-0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.4|-2.3|0.0048
71881372|NCT02634151|143281833|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.1||||0.9064|TWO_SIDED|95.0|-0.9|0.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.8|-0.9|0.9064
71881373|NCT02634151|143281833|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.2505|TWO_SIDED|95.0|-1.7|0.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||0.4|-1.7|0.2505
71881374|NCT02634151|143281834|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.8|||<|0.0001|TWO_SIDED|95.0|-22.6|-9.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-9.0|-22.6|<0.0001
71881375|NCT02634151|143281834|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-7.2||||0.0406|TWO_SIDED|95.0|-14.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||-0.3|-14.0|0.0406
71881376|NCT02634151|143281834|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-15.3|||<|0.0001|TWO_SIDED|95.0|-22.8|-7.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-7.8|-22.8|<0.0001
71921118|NCT02519777|143363157|SUPERIORITY|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm B: DTG and placebo MVC in change in Log10 NFL in CSF at Week 48 from baseline||||0.52
71921119|NCT02519777|143363157|SUPERIORITY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm A: Placebo MVC and placebo DTG and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.99
71688219|NCT04227405|142892382|SUPERIORITY||Slope|0.37|STANDARD_ERROR_OF_MEAN|0.24|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for Supportive Dyadic Coping subscale||||>.05
71881377|NCT02634151|143281835|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||-0.3|-0.9|<0.0001
71881378|NCT02634151|143281835|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.3||||0.0771|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||0.0|-0.6|0.0771
71881379|NCT02634151|143281835|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.6||||0.0006|TWO_SIDED|95.0|-1.0|-0.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||-0.3|-1.0|0.0006
71881380|NCT02634151|143281836|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.6||||0.121|TWO_SIDED|95.0|-2.3|19.6|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||19.6|-2.3|0.1210
71881381|NCT02634151|143281836|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|8.0||||0.0948|TWO_SIDED|95.0|-1.4|17.3|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 8||17.3|-1.4|0.0948
71881382|NCT02634151|143281836|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.1||||0.5113|TWO_SIDED|95.0|-8.2|16.4|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||16.4|-8.2|0.5113
71881383|NCT02634151|143281837|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|1.7||||0.7276|TWO_SIDED|95.0|-7.8|11.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 4||11.1|-7.8|0.7276
71881384|NCT02634151|143281837|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|4.7||||0.2218|TWO_SIDED|95.0|-2.9|12.2|||ANCOVA|||Week 8||12.2|-2.9|0.2218
71921120|NCT02519777|143363157|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Under the null hypothesis, it was assumed there was no difference between Arm B: DTG and placebo MVC and Arm C: MVC and DTG in change in Log10 NFL in CSF at Week 48 from baseline||||0.54
71881385|NCT02634151|143281837|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.3||||0.942|TWO_SIDED|95.0|-9.2|9.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||Week 12||9.8|-9.2|0.9420
71881386|NCT02634151|143281838|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|32.57||||0.6786|TWO_SIDED|95.0|-122.98|188.12|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||188.12|-122.98|0.6786
71881387|NCT02634151|143281839|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-0.84||||0.1648|TWO_SIDED|95.0|-2.03|0.35|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.35|-2.03|0.1648
71881388|NCT02634151|143281840|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|41.5||||0.4701|TWO_SIDED|95.0|-72.1|155.1|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||155.1|-72.1|0.4701
71881389|NCT02634151|143281841|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-32.4||||0.0517|TWO_SIDED|95.0|-65.1|0.2|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||0.2|-65.1|0.0517
71881390|NCT02634151|143281842|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-9.5||||0.9111|TWO_SIDED|95.0|-177.8|158.8|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||158.8|-177.8|0.9111
71881391|NCT02634151|143281843|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|-3.0||||0.3864|TWO_SIDED|95.0|-10.0|3.9|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||3.9|-10.0|0.3864
71881392|NCT02634151|143281844|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|12.2||||0.0145|TWO_SIDED|95.0|2.5|22.0|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||22.0|2.5|0.0145
71881393|NCT02634151|143281845|SUPERIORITY|A 2-sided test with a significance level of 0.05 was used for the comparison.|LS Mean Difference|0.8||||0.051|TWO_SIDED|95.0|0.0|1.5|||ANCOVA|Randomized treatment group, baseline statin intensity, \& diabetes status are included as factors, \& outcome at baseline is included as a covariate.||||1.5|-0.0|0.0510
71881394|NCT01035099|143281856|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.31
71881395|NCT01035099|143281857|SUPERIORITY|||||||0.19|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.19
71921121|NCT02625610|143363178|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.1779|TWO_SIDED|95.0|0.74|1.11|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).||||1.11|0.74|0.1779
71921122|NCT02625610|143363179|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.85|1.28||||||||1.28|0.85|
71688220|NCT04227405|142892382|SUPERIORITY||Slope|0.71|STANDARD_ERROR_OF_MEAN|0.31|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group||||<.05
71921123|NCT02625610|143363181|SUPERIORITY||Odds Ratio (OR)|0.91|||||TWO_SIDED|95.0|0.55|1.51||||||||1.51|0.55|
71921124|NCT00082628|143363192|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Nonparametric ANCOVA Model|||||||<0.001
71921125|NCT02364999|143363197|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk difference for confirmed response. EU equivalence margins (95% CI in -13% to 13%).|Risk Difference (RD)|0.6531|||||TWO_SIDED|95.0|-6.608|7.9082|||||PF-06439535 vs Bevacizumab-EU|||7.9082|-6.6080|
71921126|NCT02364999|143363197|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. US equivalence margins (90% CI in 0.73 to 1.37).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|90.0|0.8856|1.1625|||||PF-06439535 vs Bevacizumab-EU|||1.1625|0.8856|
71921127|NCT02364999|143363197|EQUIVALENCE|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. Japan equivalence margins (95% CI in 0.729 to 1.371).|Risk Ratio (RR)|1.0146|||||TWO_SIDED|95.0|0.8628|1.1933|||||PF-06439535 vs Bevacizumab-EU|||1.1933|0.8628|
71921128|NCT02364999|143363200|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.8||||0.1077|TWO_SIDED|95.0|0.608|1.051|||Log Rank|Stratified by smoking, sex and region.||||1.051|0.608|0.1077
71921129|NCT02364999|143363201|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.931||||0.4492||95.0|0.777|1.116|||Log Rank|Stratified by smoking, sex and region.||||1.116|0.777|0.4492
71921130|NCT02364999|143363202|OTHER|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; \>1 indicated an increase in PD/death in PF-06439535; \<1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.918||||0.4726|TWO_SIDED|95.0|0.729|1.157|||Log Rank|Stratified by smoking, sex and region.||||1.157|0.729|0.4726
71921131|NCT01566981|143363206|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6925|STANDARD_DEVIATION|1.4708||0.005|TWO_SIDED|95.0|0.2221|1.1629|||t-test, 2 sided|without adjustments, df=39||"Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05"||1.1629|0.2221|0.005
71921132|NCT00792922|143363232|SUPERIORITY|Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm \& parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % \& 97.5 % percentiles were reported.|Mean Difference (Final Values)|1.4||||0.22|TWO_SIDED|95.0|-1.0|3.8|||Regression, Linear|||"This is analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||3.8|-1|0.22
71921133|NCT00792922|143363232|SUPERIORITY|For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.|Mean Difference (Final Values)|2.6||||0.73|TWO_SIDED|95.0|-0.3|5.3|||Ordinary least squares linear regression|||"This is the analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.~Here we are looking at the prevalence of trachoma"||5.3|-0.3|0.73
71921134|NCT00792922|143363232|SUPERIORITY||Median Difference (Final Values)|-4.6||||0.2|TWO_SIDED|95.0|-11.1|1.9|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."||1.9|-11.1|0.20
71921135|NCT00792922|143363232|SUPERIORITY||Mean Difference (Final Values)|2.4||||0.6|TWO_SIDED|95.0|-7.7|12.5|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma."||12.5|-7.7|0.60
71688221|NCT04227405|142892382|SUPERIORITY||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.38|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling|||Difference between the control and the intervention group in the change from Pre-test to Post-test in the Supportive Dyadic Coping subscale|Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|||>.05
71881396|NCT01035099|143281860|SUPERIORITY|||||||0.12|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.12
71881397|NCT01035099|143281861|SUPERIORITY|||||||0.77|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.77
71881398|NCT01035099|143281862|SUPERIORITY|||||||0.63|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.63
71881399|NCT01035099|143281864|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.14
71881400|NCT01035099|143281865|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||<0.0001
71881401|NCT01035099|143281866|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.58
71881402|NCT01035099|143281868|SUPERIORITY|||||||0.42|||||||t-test, 2 sided|Nonparametric Wilcoxon rank-sum test confirmed these results.||||||0.42
71881403|NCT04962022|143281880|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|118.57||||0.05|TWO_SIDED|90.0|112.5|124.97|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||124.97|112.50|0.05
71881404|NCT04962022|143281881|OTHER|PF-07321332/ritonavir administered alone was the Reference treatment and PF-07321332/ritonavir co-administered with itraconazole was the Test treatment.|Specified in comments|138.82||||0.05|TWO_SIDED|90.0|129.25|149.11|||Mixed Models Analysis||"Mixed Model was fitted to obtain:~1.Ratio of geometric means 2.90% CI of ratio of geometric means"|||149.11|129.25|0.05
71881405|NCT01146873|143281896|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|0.107|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
71881406|NCT01146873|143281897|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|-0.007|||<|0.001|TWO_SIDED||||||Kaplan-Meier methods|||||||<0.001
71881407|NCT01146873|143281898|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71881408|NCT01146873|143281900|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Chi-squared|||||||0.003
71881409|NCT01594515|143281918|SUPERIORITY_OR_OTHER||Slope|0.9702|STANDARD_ERROR_OF_MEAN|0.0151|||TWO_SIDED|95.0|0.94|1.0005|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50)||1.0005|0.9400|
71881410|NCT01594515|143281919|SUPERIORITY_OR_OTHER||Slope|1.0442|STANDARD_ERROR_OF_MEAN|0.0148|||TWO_SIDED|95.0|1.0145|1.074|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale."|This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48)||1.0740|1.0145|
71881411|NCT00841789|143281938|SUPERIORITY|||||||0.1|||||||Chi-squared|||||||.10
71881412|NCT00841789|143281939|SUPERIORITY|||||||0.86|||||||Regression, Cox|||We applied a Generalized Estimating Equation (GEE) model to determine z score change values (see Protocol page 36 in Supplement).||||0.86
71881413|NCT00841789|143281940|SUPERIORITY|||||||0.83|||||||GEE|||General Estimating Equation||||.83
71881414|NCT00841789|143281940|OTHER|Generallzed Estimating Equation was used for z-score change within groups compared to baseline|General Estimating Equation|||||0.1279|||||||GEE|||We analyzed change from baseline for both etanercept and placebo. LS mean change J(standard error) reported||||0.1279
71881415|NCT00841789|143281941|OTHER|General Estimating Equation for 3 coronary arteries.||||||0.03|||||||GEE|||General Estimating Equation|Generalize estimating equation for 3 coronary arteries evaluated in each patient by echocardiography|||0.03
71881416|NCT00841789|143281941|OTHER|see above||||||0.619|||||||GEE|||GEE performed to compare with change in coronary z score from baseline||||0.619
71881417|NCT03317795|143281972|SUPERIORITY|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||||||0.11
71881418|NCT03317795|143281974|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71881419|NCT03317795|143281975|SUPERIORITY|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Physical composite score||||0.32
71881420|NCT03317795|143281975|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Mental composite score||||0.26
71881421|NCT03317795|143281976|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71881422|NCT03317795|143281977|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
71881423|NCT01664559|143281993|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.99
71881424|NCT01664559|143281994|SUPERIORITY_OR_OTHER|||||||0.31|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) Anticipated pain||||0.31
71881425|NCT01664559|143281994|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||0.33
71881426|NCT01664559|143281994|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.72
71881427|NCT01664559|143281994|SUPERIORITY_OR_OTHER|||||||0.36|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.36
71881428|NCT01664559|143281994|SUPERIORITY_OR_OTHER|||||||0.64|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.64
71881429|NCT01664559|143281994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) 5 min after placement||||<0.001
71881430|NCT01664559|143281994|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 15 min after placement||||<0.001
71881431|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||1\) anticipated pain||||0.6
71881432|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||2\) pain with injection||||1.0
71881433|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||3\) speculum insertion||||0.34
71881434|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||4\) tenaculum placement||||0.32
71881435|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||5\) uterine sounding||||0.04
71881436|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||6\) IUD placement||||0.02
71881437|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||7\) 5 min after placement||||0.32
71881438|NCT01664559|143281995|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||8\) 15 min after placement||||0.02
71881439|NCT01664559|143281996|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)||||> 0.05
71881440|NCT01664559|143281996|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Injection site pain (just as bad or worse than IUD procedure)||||0.76
71881441|NCT01664559|143281996|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED||||||Chi-squared|||Satisfied or very satisfied with IUD placement procedure||||0.76
71881442|NCT01664559|143281996|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||Chi-squared|||Would recommend IUD placement to a friend||||0.35
71881443|NCT01664559|143281996|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Desires additional pain medication||||0.02
71881444|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Chi-squared|||Level of training, PGY 1, 2, 3, 4 and Attending||||0.2
71881445|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||IUD type (levonorgestrel or copper)||||0.09
71881446|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Purpose of IUD (contraception or heavy menstrual bleeding)||||1.0
71881447|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED||||||Chi-squared|||Position of uterus (anteverted, retroverted, midpositioned)||||0.92
71881448|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Need for cervical dilation||||1.0
71881449|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared, Corrected|||Able to complete the IUD insertion||||1.0
71881450|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||Chi-squared|||Significant bleeding||||0.24
71881451|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||Major complications||||1.0
71688222|NCT04227405|142892382|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.3|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the common dyadic coping subscale||||>.05
71688223|NCT04227405|142892382|SUPERIORITY||Slope|1.21|STANDARD_ERROR_OF_MEAN|0.39|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping subscale||||<.01
71688224|NCT04227405|142892382|SUPERIORITY||Slope|0.97|STANDARD_ERROR_OF_MEAN|0.47|<|0.1|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Common Dyadic Coping Subscale||||<.10
71921136|NCT02394028|143363267|SUPERIORITY||Difference in rate|1.1||||0.8508|TWO_SIDED|95.0|-10.85|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-10.85|0.8508
71921137|NCT02394028|143363267|SUPERIORITY||Difference in rate|3.8||||0.5235|TWO_SIDED|95.0|-8.3|15.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.27|-8.30|0.5235
71921138|NCT02394028|143363269|SUPERIORITY||Difference in rate|4.9||||0.7908|TWO_SIDED|95.0|-6.26|16.11||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||16.11|-6.26|0.7908
71921139|NCT02394028|143363269|SUPERIORITY||Difference in rate|5.8||||0.317|TWO_SIDED|95.0|-5.43|17.05||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||17.05|-5.43|0.3170
71921140|NCT02394028|143363270|SUPERIORITY||Difference in rate|11.3||||0.0088|TWO_SIDED|95.0|2.7|19.65||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.65|2.70|0.0088
71921141|NCT02394028|143363271|SUPERIORITY||Difference in rate|11.5||||0.0026|TWO_SIDED|95.0|4.11|18.83||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||18.83|4.11|0.0026
71921142|NCT02394028|143363273|SUPERIORITY||Difference in rate|3.1||||1|TWO_SIDED|95.0|-8.02|13.45||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||13.45|-8.02|1
71921143|NCT02394028|143363273|SUPERIORITY||Difference in rate|2.3||||0.7908|TWO_SIDED|95.0|-8.78|12.56||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||12.56|-8.78|0.7908
71921144|NCT02394028|143363275|SUPERIORITY||Difference in rate|1.6||||1|TWO_SIDED|95.0|-6.51|9.73||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||9.73|-6.51|1
71921145|NCT02394028|143363275|SUPERIORITY||Difference in rate|6.5||||0.5235|TWO_SIDED|95.0|-2.24|15.16||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates are adjusted using CMH weights and the 95% CIs use the Newcombes method.|||15.16|-2.24|0.5235
71921146|NCT02394028|143363276|SUPERIORITY||Difference in LSM|-0.5||||0.311|TWO_SIDED|90.0|-1.4|0.3|||MMRM|||Bowel Domain Score||0.3|-1.4|0.3110
71921147|NCT02394028|143363277|SUPERIORITY||Difference in LSM|0.2||||1|TWO_SIDED|95.0|-0.5|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Scale||0.9|-0.5|1
71921148|NCT02394028|143363277|SUPERIORITY||Difference in LSM|0.0||||1|TWO_SIDED|95.0|-0.7|0.7||The multiplicity adjusted p-values are presented.|MMRM|||Functional Domain Score||0.7|-0.7|1
71921149|NCT02394028|143363277|SUPERIORITY||Difference in LSM|0.1||||1|TWO_SIDED|95.0|-0.8|0.9||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.9|-0.8|1
71921150|NCT02394028|143363277|SUPERIORITY||Difference in LSM|-0.3||||1|TWO_SIDED|95.0|-1.1|0.5||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Domain Score||0.5|-1.1|1
71921151|NCT02394028|143363278|SUPERIORITY||Difference in rate|17.3||||0.0677|TWO_SIDED|95.0|3.52|30.27||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||30.27|3.52|0.0677
71921152|NCT02394028|143363279|SUPERIORITY||Difference in rates|18.6||||0.048|TWO_SIDED|95.0|11.07|25.96||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||25.96|11.07|0.0480
71921153|NCT02394028|143363280|SUPERIORITY||Difference in rates|13.5||||0.121|TWO_SIDED|95.0|-2.9|29.94|||Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||29.94|-2.90|0.1210
71921154|NCT02394028|143363281|SUPERIORITY||Difference in rates|6.2||||0.048|TWO_SIDED|95.0|0.54|11.93||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||11.93|0.54|0.0480
71921155|NCT02394028|143363282|SUPERIORITY||Difference in rates|11.2||||0.0677|TWO_SIDED|95.0|3.04|19.24||The multiplicity adjusted p-values are presented.|Cochran-Mantel-Haenszel||Difference in response rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||19.24|3.04|0.0677
71921156|NCT02394028|143363283|SUPERIORITY||Difference in rates|16.2||||0.0035|TWO_SIDED|95.0|8.96|23.31||Nominal p-value, no adjustment for multiplicity performed.|Cochran-Mantel-Haenszel||Difference in remission rates is adjusted using CMH weights and the 95% CIs use the Newcombes method.|||23.31|8.96|0.0035
71921157|NCT02394028|143363284|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-0.9|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Functional Symptoms Domain||0.4|-0.9|0.4009
71688225|NCT04227405|142892382|SUPERIORITY||Slope|-0.74|STANDARD_ERROR_OF_MEAN|0.37|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Negative Dyadic Coping Subscale||||<.10
71688226|NCT04227405|142892382|SUPERIORITY||Slope|-1.14|STANDARD_ERROR_OF_MEAN|0.49|<|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping subscale||||<.05
71688227|NCT04227405|142892382|SUPERIORITY||Slope|-0.39|STANDARD_ERROR_OF_MEAN|0.6|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Negative Dyadic Coping Scale||||>.05
71688228|NCT04227405|142892383|SUPERIORITY||Slope|0.57|STANDARD_ERROR_OF_MEAN|0.29|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the control group for the Supportive Dyadic Coping Subscale||||>.05
71688229|NCT04227405|142892383|SUPERIORITY||Slope|0.7|STANDARD_ERROR_OF_MEAN|0.37|<|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to follow-up for the intervention group for the Supportive Dyadic Coping Subscale||||<.05
71688230|NCT04227405|142892383|SUPERIORITY||Slope|0.19|STANDARD_ERROR_OF_MEAN|0.46|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to follow-up in the intervention group were not significantly different from the change from pre-test to follow-up in the control group|Difference between the control and the intervention group in the change from pre-test to follow-up for the Supportive Dyadic Coping Subscale||||>.05
71688231|NCT04227405|142892385|SUPERIORITY||Slope|0.03|STANDARD_ERROR_OF_MEAN|0.26|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group in the Supportive Dyadic Coping Subcale||||>.05
71688232|NCT04227405|142892385|SUPERIORITY||Slope|1.45|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Supportive Dyadic Coping Scale||||<.001
71881452|NCT01664559|143281997|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Chi-squared|||Took acetaminophen prior to leaving the office||||0.02
71688233|NCT04227405|142892385|SUPERIORITY||Slope|1.42|STANDARD_ERROR_OF_MEAN|0.41|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test||||<.01
71688234|NCT04227405|142892385|SUPERIORITY||Slope|0.22|STANDARD_ERROR_OF_MEAN|0.35|>|0.05|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Common Dyadic Coping Subscale||||>.05
71688235|NCT04227405|142892385|SUPERIORITY||Slope|2.12|STANDARD_ERROR_OF_MEAN|0.45|<|0.001|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group in the Common Dyadic Coping Subscale||||<.001
71921158|NCT02394028|143363284|SUPERIORITY||Difference in LSM|-0.3||||0.4009|TWO_SIDED|95.0|-1.0|0.4||The multiplicity adjusted p-values are presented.|MMRM|||Bowel Symptoms Domain||0.4|-1.0|0.4009
71921159|NCT02514889|143363305|SUPERIORITY||Mean Difference (Final Values)|-2.11|STANDARD_ERROR_OF_MEAN|2.05||0.3|TWO_SIDED|95.0|-6.12|1.91||a priori threshold is p = .017, so that experiment-wide critical alpha would be p = .05.|Mixed Models Analysis|Covariates: sex, age, ethnicity, marital status and educational attainment|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||1.91|-6.12|0.30
71921160|NCT02514889|143363306|EQUIVALENCE|p-value \>0.20 would be considered equivalent.|Mean Difference (Final Values)|2.59|STANDARD_ERROR_OF_MEAN|1.39||0.06|TWO_SIDED|95.0|-0.1342|5.3228|||Mixed Models Analysis|Covariates included age, sex, ethnicity, educational attainment and marital status||||5.3228|-0.1342|0.06
71921161|NCT02514889|143363307|SUPERIORITY||Mean Difference (Net)|-1.37|STANDARD_ERROR_OF_MEAN|2.55||0.504|TWO_SIDED|95.0|-6.37|3.63|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).|||3.63|-6.37|0.504
71921162|NCT02514889|143363308|SUPERIORITY|Difference in differences|Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|2.35||0.3|TWO_SIDED|95.0|-6.47|2.74|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment, marital status|The difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.74|-6.47|0.30
71921163|NCT02514889|143363309|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.99||0.64|TWO_SIDED|95.0|-1.47|2.39|||Mixed Models Analysis||The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||2.39|-1.47|0.640
71921164|NCT02514889|143363310|EQUIVALENCE|For the comparison conditions to be equivalent, as predicted, the critical alpha was set at P \> 0.20.|Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.135||0.747|TWO_SIDED|95.0|-0.31|0.22|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||0.22|-.31|0.747
71921165|NCT02514889|143363311|EQUIVALENCE|For the comparison conditions to be judged equivalent, as predicted, the critical p-value was set to P \>.20|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.51||0.776|TWO_SIDED|95.0|-0.85|1.14|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)|||1.14|-0.85|0.776
71921166|NCT03479203|143363347|OTHER|T-Test followed by Bonferroni post-hoc analysis.|Mean Difference (Final Values)|1.96|STANDARD_DEVIATION|1.5||0.05|TWO_SIDED|95.0|1.0|6.0|||t-test, 2 sided|||"Blood assessed for C-reactive protein (CRP), soluble intercellular adhesion molecule (sICAM), the high mobility group box-1 (HMGB1), the NLRP3 inflammasome, and nitrates (NOx for nitric oxide) pre- and post-vaping. CRP, sICAM HMGB1 and NLRP3 is in ng/ml blood and NOx is in nanomol/ml. These numbers were weighted to obtain an inflammation index in blood. This index represents the fold increase over pre-vaping values."||6|1|0.05
71921167|NCT03419741|143363355|OTHER|We plan to enroll 20 participants within one year. Eleven participants were enrolled. 11/20 = 55% completed the number of enrollment.|%|11.0|||||TWO_SIDED||||||percentage|||||||
71921168|NCT01091116|143363398|SUPERIORITY_OR_OTHER|||||||0.5263||95.0|||||ANCOVA|||Tests of Fixed Effects for the primary efficacy variable including baseline treatment and visit (from Visit 3 to Visit 5) as covariates||||0.5263
71921169|NCT02194699|143363412|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.84||||0.4656|TWO_SIDED|95.0|0.53|1.34|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.34|0.53|0.4656
71922486|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.6||||0.822|TWO_SIDED|95.0|-15.0|11.8|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-15.0|0.822
71688236|NCT04227405|142892385|SUPERIORITY||Slope|1.91|STANDARD_ERROR_OF_MEAN|0.55|<|0.01|TWO_SIDED|||||The Benjamini-Hochberg method (1995) was used for adjusting p values for multiple comparisons as recommended by What Works Clearinghouse for controlling the false discovery rate for studies that have multiple outcome variables.|Multilevel modeling||Changes from pre-test to post-test in the intervention group were significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test inn the Common Dyadic Coping subscale||||<.01
71688237|NCT04227405|142892385|SUPERIORITY||Slope|-0.68|STANDARD_ERROR_OF_MEAN|0.42|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the control group for the Negative Dyadic Coping Scale||||>.05
71921170|NCT02194699|143363412|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.13||||0.4126|TWO_SIDED|95.0|0.85|1.5|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.50|0.85|0.4126
71921171|NCT02194699|143363412|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|15.83||||0.4656|TWO_SIDED|95.0|-33.71|47.01|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||47.01|-33.71|0.4656
71921172|NCT02194699|143363412|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.03||||0.8027|TWO_SIDED|95.0|0.81|1.31|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.||1.31|0.81|0.8027
71921173|NCT02194699|143363412|SUPERIORITY|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|-3.14||||0.8027|TWO_SIDED|95.0|-31.46|19.08|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.||19.08|-31.46|0.8027
71921174|NCT02194699|143363413|SUPERIORITY||Least square (LS) Mean difference|1.86||||0.6033|TWO_SIDED|95.0|-5.16|8.88|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||8.88|-5.16|0.6033
71921175|NCT02194699|143363413|SUPERIORITY||LS Mean difference|3.37||||0.1276|TWO_SIDED|95.0|-0.97|7.7|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||7.70|-0.97|0.1276
71921176|NCT02194699|143363413|SUPERIORITY||LS Mean difference|2.95||||0.1164|TWO_SIDED|95.0|-0.73|6.62|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment||6.62|-0.73|0.1164
71921177|NCT02194699|143363414|SUPERIORITY||LS Mean difference|-0.2||||0.1456|TWO_SIDED|95.0|-0.47|0.07|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.07|-0.47|0.1456
71881453|NCT02189213|143282033|OTHER|The parameters were the CGI-Improvement scale which comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The hypothesis is that \~50% of subjects receiving treatment will not respond.|||||=|0.0002|||||||t-test, 2 sided|||At least 50% of subjects will respond to Sertraline treatment (CGI greater than or equal to 2).||||=0.0002
71881454|NCT02424253|143282038|SUPERIORITY||LS Difference|-0.35|||=|0.249|TWO_SIDED|90.0|-1.21|0.51||1-sided p-value.|ANCOVA|The ANCOVA model included baseline value and treatment.||Change from baseline||0.51|-1.21|= 0.249
71881455|NCT02424253|143282039|SUPERIORITY||LS Difference|-5.06|||=|0.01|TWO_SIDED|90.0|-8.66|-1.46||1-sided p-value.|ANCOVA|The ANCOVA model included baseline EASI, stratification variable (worst daily pruritus NRS ≤ 7.5 or \> 7.5) and treatment.||Change from baseline analysis||-1.46|-8.66|= 0.01
71881456|NCT03998046|143282061|SUPERIORITY|||||||0.85|||||||Chi-squared|||||||.85
71881457|NCT03998046|143282063|SUPERIORITY|||||||0.2|||||||t-test, 2 sided|||||||.20
71881458|NCT03998046|143282064|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||||||.38
71881459|NCT03998046|143282065|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||.02
71881460|NCT03998046|143282066|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||.01
71881461|NCT03998046|143282067|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||||||.13
71881462|NCT03998046|143282068|SUPERIORITY|||||||0.61|||||||t-test, 2 sided|||||||.61
71881463|NCT03998046|143282069|SUPERIORITY|||||||0.56|||||||Chi-squared|||||||.56
71881464|NCT02290873|143282070|SUPERIORITY||Difference in Rates|0.8961|||<|0.0001|TWO_SIDED|95.0|0.8505|0.9416||P-value calculated from a Cochran-Mantel-Haenszel test accounting for fentanyl strata.|Cochran-Mantel-Haenszel|||||0.9416|0.8505|<0.0001
71881465|NCT02290873|143282071|SUPERIORITY||Hazard Ratio (HR)|6.133|||<|0.0001|TWO_SIDED|95.0|4.416|8.517|||Log Rank|||||8.517|4.416|<0.0001
71881466|NCT01519765|143282094|SUPERIORITY_OR_OTHER|||||||0.1611|||||||Fisher Exact|||A consecutive sample will be used as women are recruited. Based on an 80% power and an alpha of 0.05, a sample size of 103 subjects in each arm is required to detect a 20% difference between deliveries within 24hrs between the two treatment arms. An effect size of 20% was selected as this is thought to be a clinically significant difference. This is based on the Wing study showing 50% delivery within 24 hrs with vaginal misoprostol.||||0.1611
71881467|NCT01519765|143282095|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED||||||t-test, 2 sided|||||||0.018
71881468|NCT01519765|143282096|SUPERIORITY_OR_OTHER|||||||0.0623|||||||Kruskal-Wallis|||||||0.0623
71881469|NCT01519765|143282097|SUPERIORITY_OR_OTHER|||||||0.1141|TWO_SIDED||||||Kruskal-Wallis|||||||0.1141
71881470|NCT01519765|143282098|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
71881471|NCT01519765|143282099|SUPERIORITY_OR_OTHER|||||||0.4469|TWO_SIDED||||||Fisher Exact|||||||0.4469
71881472|NCT01519765|143282100|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED||||||Kruskal-Wallis|||||||0.093
71881473|NCT01519765|143282101|SUPERIORITY_OR_OTHER|||||||0.2417|TWO_SIDED||||||Fisher Exact|||||||0.2417
71881474|NCT01519765|143282102|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
71881475|NCT01519765|143282103|SUPERIORITY_OR_OTHER|||||||0.1054|TWO_SIDED||||||Fisher Exact|||||||0.1054
71881476|NCT01519765|143282104|SUPERIORITY_OR_OTHER|||||||0.8043|TWO_SIDED||||||Fisher Exact|||||||0.8043
71881477|NCT01519765|143282105|SUPERIORITY_OR_OTHER|||||||0.797|TWO_SIDED||||||Fisher Exact|||||||0.797
71881478|NCT01519765|143282106|SUPERIORITY_OR_OTHER|||||||0.751|||||||Fisher Exact|||||||0.751
71881479|NCT01519765|143282107|SUPERIORITY_OR_OTHER|||||||0.6244|TWO_SIDED||||||Fisher Exact|||||||0.6244
71881480|NCT01519765|143282108|SUPERIORITY_OR_OTHER|||||||0.7906|TWO_SIDED||||||Fisher Exact|||||||0.7906
71881481|NCT01519765|143282109|SUPERIORITY_OR_OTHER|||||||0.5118|TWO_SIDED||||||Fisher Exact|||||||0.5118
71881482|NCT01519765|143282110|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1
71881483|NCT01519765|143282111|SUPERIORITY_OR_OTHER|||||||0.741|TWO_SIDED||||||Fisher Exact|||||||0.741
71881484|NCT01519765|143282112|SUPERIORITY_OR_OTHER|||||||0.579|TWO_SIDED||||||Kruskal-Wallis|||||||0.579
71881485|NCT01519765|143282113|SUPERIORITY_OR_OTHER|||||||0.8062|||||||Kruskal-Wallis|||Score for Nausea and vomiting||||.8062
71881486|NCT01519765|143282113|SUPERIORITY_OR_OTHER|||||||0.1505|||||||Kruskal-Wallis|||Effectiveness||||0.1505
71881487|NCT01519765|143282113|SUPERIORITY_OR_OTHER|||||||0.1223|||||||Kruskal-Wallis|||Patient concern||||0.1223
71881488|NCT01519765|143282113|SUPERIORITY_OR_OTHER|||||||0.538||||||Patient satisfaction|Kruskal-Wallis|||Labor satisfaction||||0.5380
71881489|NCT01519765|143282114|SUPERIORITY_OR_OTHER|||||||0.2868||||||This is the overall p value of all rows.|Chi-squared|||||||0.2868
71881490|NCT02354222|143282131|SUPERIORITY||Least Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-1.16|-0.72|||ANCOVA|||||-0.72|-1.16|<0.001
71881491|NCT02354222|143282132|SUPERIORITY||Least Squares Mean Difference|-15.6|STANDARD_ERROR_OF_MEAN|3.9|<|0.001|TWO_SIDED|95.0|-23.3|-7.9|||ANCOVA|||||-7.9|-23.3|<0.001
71881492|NCT02354222|143282133|SUPERIORITY||Least Squares Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|0.63|2.23|||ANCOVA|||||2.23|0.63|<0.001
71881493|NCT02354222|143282134|SUPERIORITY||Least Squares Mean Difference|-55.9|STANDARD_ERROR_OF_MEAN|9.2|<|0.001|TWO_SIDED|95.0|-74.1|-37.6|||ANCOVA|||||-37.6|-74.1|<0.001
71881494|NCT02354222|143282135|SUPERIORITY||Least Squares Mean Difference|-37.6|STANDARD_ERROR_OF_MEAN|6.2|<|0.001|TWO_SIDED|95.0|-49.9|-25.2|||ANCOVA|||||-25.2|-49.9|<0.001
71881495|NCT01699542|143282136|SUPERIORITY|||||||0.159|||||||Generalized Linear Model|||||||0.159
71881496|NCT01342484|143282148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|0.48||0.3295|TWO_SIDED|95.0|-1.47|0.51|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, pharmacokinetic (PK) / pharmacodynamics (PD) subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.51|-1.47|0.3295
71881497|NCT01342484|143282148|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.42||0.1447|TWO_SIDED|95.0|-1.5|0.23|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.23|-1.50|0.1447
71881498|NCT01342484|143282150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31|STANDARD_ERROR_OF_MEAN|1.36||0.8216|TWO_SIDED|95.0|-3.08|2.46|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||2.46|-3.08|0.8216
71881499|NCT01342484|143282150|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9|STANDARD_ERROR_OF_MEAN|1.18||0.1189|TWO_SIDED|95.0|-4.31|0.52|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.||0.52|-4.31|0.1189
71881500|NCT00432042|143282193|NON_INFERIORITY_OR_EQUIVALENCE|Measles difference|Mean Difference (Final Values)|1.14|||||TWO_SIDED|95.0|-1.62|4.82|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||4.82|-1.62|
71881501|NCT00432042|143282193|NON_INFERIORITY_OR_EQUIVALENCE|Mumps difference|Mean Difference (Final Values)|-1.83|||||TWO_SIDED|95.0|-4.21|1.1|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.10|-4.21|
71881502|NCT00432042|143282193|NON_INFERIORITY_OR_EQUIVALENCE|Rubella difference|Mean Difference (Final Values)|-1.2|||||TWO_SIDED|95.0|-3.19|1.35|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||1.35|-3.19|
71881503|NCT00432042|143282193|NON_INFERIORITY_OR_EQUIVALENCE|Varicella difference|Mean Difference (Final Values)|2.53|||||TWO_SIDED|95.0|-0.41|6.58|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -10%.|||6.58|-0.41|
71881504|NCT00432042|143282194|NON_INFERIORITY_OR_EQUIVALENCE|Hepatitis B difference|Mean Difference (Final Values)|1.36|||||TWO_SIDED|95.0|-0.29|4.24|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||4.24|-0.29|
71881505|NCT00432042|143282194|NON_INFERIORITY_OR_EQUIVALENCE|Haemophilus Influenza type B difference|Mean Difference (Final Values)|2.97|||||TWO_SIDED|95.0|-0.17|6.89|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||6.89|-0.17|
71881506|NCT00432042|143282195|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PT difference|GMT ratio|0.97|||||TWO_SIDED|95.0|0.88|1.08|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.08|0.88|
71881507|NCT00432042|143282195|NON_INFERIORITY_OR_EQUIVALENCE|Anti-FHA difference|GMT ratio|1.09|||||TWO_SIDED|95.0|0.98|1.23|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.23|0.98|
71881508|NCT00432042|143282195|NON_INFERIORITY_OR_EQUIVALENCE|Anti-PRN difference|GMT ratio|1.18|||||TWO_SIDED|95.0|1.03|1.36|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is \> -5%.|||1.36|1.03|
71881509|NCT02822885|143282196|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71881510|NCT02822885|143282197|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71881511|NCT02822885|143282198|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71881512|NCT02822885|143282199|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71921178|NCT02194699|143363414|SUPERIORITY||LS Mean difference|0.04||||0.6548|TWO_SIDED|95.0|-0.13|0.2|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.20|-0.13|0.6548
71881513|NCT02822885|143282200|SUPERIORITY_OR_OTHER||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided|||||||<0.05
71881514|NCT04013529|143282203|SUPERIORITY||||||=|0.9|||||||ANCOVA|||||||=0.90
71881515|NCT04013529|143282204|SUPERIORITY||||||=|0.88|||||||ANCOVA|||||||= 0.88
71881516|NCT04013529|143282205|SUPERIORITY||||||<|0.17|||||||ANCOVA|||||||< 0.17
71688238|NCT04227405|142892385|SUPERIORITY||Slope|-1.02|STANDARD_ERROR_OF_MEAN|0.53|<|0.1|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||A positive value indicates an increase while a negative value indicates a decrease|Change from pre-test to post-test for the intervention group for the Negative Dyadic Coping Scale||||<.10
71688239|NCT04227405|142892385|SUPERIORITY||Slope|-0.34|STANDARD_ERROR_OF_MEAN|0.65|>|0.05|TWO_SIDED|||||No adjustment in p value|Multilevel modeling||Changes from pre-test to post-test in the intervention group were not significantly different from the change from pre-test to post-test in the control group|Difference between the control and the intervention group in the change from Pre-test to Post-test for the Negative Dyadic Coping Subscale||||>.05
71881517|NCT04013529|143282206|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||< 0.05
71881518|NCT04013529|143282207|SUPERIORITY||||||=|0.81|||||||ANCOVA|||||||= 0.81
71881519|NCT01733628|143282225|OTHER|Type of statistical Test: Inequality|Hazard Ratio (HR)|0.94||||0.8166|TWO_SIDED|95.0|0.56|1.59|||Wilcoxon (Mann-Whitney)|||||1.59|0.56|0.8166
71881520|NCT02347098|143282257|SUPERIORITY|||||||0.2533|||||||t-test, 2 sided|||||||0.2533
71881521|NCT02347098|143282258|SUPERIORITY|||||||0.779|||||||t-test, 2 sided|||||||0.7790
71881522|NCT02347098|143282259|SUPERIORITY|||||||0.4549||||||The p-value reported compares the trends of outcome across time (baseline pre-PCI, baseline post-PCI, 30-day follow-up, and 90-day follow-up) between treatment groups using the repeated measurement analysis.|Mixed Models Analysis|||||||0.4549
71881523|NCT02347098|143282260|SUPERIORITY|||||||0.2663|||||||Fisher Exact|||||||0.2663
71881524|NCT02187172|143282261|SUPERIORITY||Mean Difference (Final Values)|-0.2456|STANDARD_ERROR_OF_MEAN|0.07||0.0012|TWO_SIDED|95.0|-0.3873|-0.104|||Regression, Linear|||Comparison during RCT period||-0.1040|-0.3873|0.0012
71881525|NCT02187172|143282261|SUPERIORITY||Mean Difference (Final Values)|-0.0151|STANDARD_ERROR_OF_MEAN|0.0353||0.6718|TWO_SIDED|95.0|-0.0867|0.0565|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.0565|-0.0867|0.6718
71921179|NCT02194699|143363414|SUPERIORITY||LS Mean difference|-0.04||||0.5763|TWO_SIDED|95.0|-0.18|0.1|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.10|-0.18|0.5763
71921180|NCT02194699|143363415|SUPERIORITY||LS Mean difference|0.27||||0.0874|TWO_SIDED|95.0|-0.04|0.57|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.57|-0.04|0.0874
71921181|NCT02194699|143363415|SUPERIORITY||LS Mean difference|-0.01||||0.9083|TWO_SIDED|95.0|-0.2|0.17|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.17|-0.20|0.9083
71921182|NCT02194699|143363415|SUPERIORITY||LS Mean difference|0.06||||0.4506|TWO_SIDED|95.0|-0.1|0.22|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.22|-0.10|0.4506
71921183|NCT02194699|143363416|SUPERIORITY||LS Mean difference|-0.27||||0.04|TWO_SIDED|95.0|-0.53|-0.01|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.01|-0.53|0.0400
71921184|NCT02194699|143363416|SUPERIORITY||LS Mean difference|0.0||||0.9735|TWO_SIDED|95.0|-0.16|0.16|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.16|-0.16|0.9735
71881526|NCT02187172|143282262|SUPERIORITY||Mean Difference (Final Values)|-64.97|STANDARD_ERROR_OF_MEAN|44.88||0.1159|TWO_SIDED|95.0|-115.83|25.89|||Regression, Linear|||Comparison during RCT period||25.89|-115.83|0.1159
71881527|NCT02187172|143282262|SUPERIORITY||Mean Difference (Final Values)|6.65|STANDARD_ERROR_OF_MEAN|22.24||0.7666|TWO_SIDED|95.0|-38.41|51.72|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||51.72|-38.41|0.7666
71881528|NCT02187172|143282263|SUPERIORITY||Mean Difference (Final Values)|-80.89|STANDARD_ERROR_OF_MEAN|30.46||0.0115|TWO_SIDED|95.0|-142.55|-19.23|||Regression, Linear|||Comparison during RCT period||-19.23|-142.55|0.0115
71881529|NCT02187172|143282263|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|14.11||0.8883|TWO_SIDED|95.0|-30.58|26.59|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||26.59|-30.58|0.8883
71921185|NCT02194699|143363416|SUPERIORITY||LS Mean difference|-0.08||||0.2432|TWO_SIDED|95.0|-0.21|0.05|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.05|-0.21|0.2432
71881530|NCT02187172|143282264|SUPERIORITY||Mean Difference (Final Values)|-3027.21|STANDARD_ERROR_OF_MEAN|3180.58||0.3472|TWO_SIDED|95.0|-9465.95|3411.54|||Regression, Linear|||Comparison during RCT period||3411.54|-9465.95|0.3472
71881531|NCT02187172|143282264|SUPERIORITY||Mean Difference (Final Values)|-1974.63|STANDARD_ERROR_OF_MEAN|1659.11||0.2416|TWO_SIDED|95.0|-5336.3|1387.04|||Regression, Linear|||Combined ustekinumab and placebo groups for active treatment period analysis.||1387.04|-5336.30|0.2416
71881532|NCT02187172|143282265|SUPERIORITY||Mean Difference (Final Values)|20.66|STANDARD_ERROR_OF_MEAN|24.75||0.6742|TWO_SIDED|95.0|-78.03|119.34|||Regression, Linear|||Comparison during RCT period||119.34|-78.03|0.6742
71881533|NCT02187172|143282265|SUPERIORITY||Mean Difference (Final Values)|47.0|STANDARD_ERROR_OF_MEAN|35.84||0.1979|TWO_SIDED|95.0|-25.63|11963.0|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||11963|-25.63|0.1979
71881534|NCT02187172|143282266|SUPERIORITY||Mean Difference (Final Values)|-7884.29|STANDARD_ERROR_OF_MEAN|7780.29||0.3173|TWO_SIDED|95.0|-23634.67|7566.1|||Regression, Linear|||Comparison during RCT period||7566.10|-23634.67|0.3173
71881535|NCT02187172|143282266|SUPERIORITY||Mean Difference (Final Values)|-3782.54|STANDARD_ERROR_OF_MEAN|4073.25||0.3591|TWO_SIDED|95.0|-12035.72|4470.64|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4470.64|-12035.72|0.3591
71881536|NCT02187172|143282267|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|2.54||0.9767|TWO_SIDED|95.0|-5.22|5.07|||Regression, Linear|||Comparison during RCT period||5.07|-5.22|0.9767
71881537|NCT02187172|143282267|SUPERIORITY||Mean Difference (Final Values)|-1.09|STANDARD_ERROR_OF_MEAN|1.09||0.3205|TWO_SIDED|95.0|-3.29|1.11|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.11|-3.29|0.3205
71881538|NCT02187172|143282268|SUPERIORITY||Mean Difference (Final Values)|-14.79|STANDARD_ERROR_OF_MEAN|19.96||0.4632|TWO_SIDED|95.0|-55.19|25.61|||Regression, Linear|||Comparison during RCT period||25.61|-55.19|0.4632
71881539|NCT02187172|143282268|SUPERIORITY||Mean Difference (Final Values)|-7.24|STANDARD_ERROR_OF_MEAN|11.47||0.5316|TWO_SIDED|95.0|-30.47|15.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||15.99|-30.47|0.5316
71881540|NCT02187172|143282269|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.68||0.1928|TWO_SIDED|95.0|-2.27|0.47|||Regression, Linear|||Comparison during RCT period||0.47|-2.27|0.1928
71881541|NCT02187172|143282269|SUPERIORITY||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.34||0.058|TWO_SIDED|95.0|-1.36|0.02|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.02|-1.36|0.0580
71881542|NCT02187172|143282270|SUPERIORITY||Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|11.41||0.7185|TWO_SIDED|95.0|-27.24|18.96|||Regression, Linear|||Comparison during RCT period||18.96|-27.24|0.7185
71881543|NCT02187172|143282270|SUPERIORITY||Mean Difference (Final Values)|-8.35|STANDARD_ERROR_OF_MEAN|8.41||0.3271|TWO_SIDED|95.0|-25.4|8.69|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||8.69|-25.40|0.3271
71881544|NCT02187172|143282271|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.51||0.3124|TWO_SIDED|95.0|-1.56|0.51|||Regression, Linear|||Comparison during RCT period||0.51|-1.56|0.3124
71881545|NCT02187172|143282271|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.11||0.0106|TWO_SIDED|95.0|-0.54|-0.08|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.08|-0.54|0.0106
71881546|NCT02187172|143282272|SUPERIORITY||Mean Difference (Final Values)|-70.76|STANDARD_ERROR_OF_MEAN|33.42||0.0408|TWO_SIDED|95.0|-138.42|-3.11|||Regression, Linear|||Comparison during RCT period||-3.11|-138.42|0.0408
71881547|NCT02187172|143282272|SUPERIORITY||Mean Difference (Final Values)|71.72|STANDARD_ERROR_OF_MEAN|132.87||0.5926|TWO_SIDED|95.0|-197.5|340.93|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||340.93|-197.50|0.5926
71881548|NCT02187172|143282273|SUPERIORITY||Mean Difference (Final Values)|191.49|STANDARD_ERROR_OF_MEAN|46.1||0.0002|TWO_SIDED|95.0|98.18|284.81|||Regression, Linear|||Comparison during RCT period||284.81|98.18|0.0002
71881549|NCT02187172|143282273|SUPERIORITY||Mean Difference (Final Values)|171.21|STANDARD_ERROR_OF_MEAN|20.3|<|0.0001|TWO_SIDED|95.0|130.08|212.34|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||212.34|130.08|<0.0001
71881550|NCT02187172|143282274|SUPERIORITY||Mean Difference (Final Values)|-2.63|STANDARD_ERROR_OF_MEAN|0.98||0.011|TWO_SIDED|95.0|-4.62|-0.64|||Regression, Linear|||Comparison during RCT period||-0.64|-4.62|0.0110
71881551|NCT02187172|143282274|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.32||0.0008|TWO_SIDED|95.0|-1.79|-0.51|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-0.51|-1.79|0.0008
71881552|NCT02187172|143282275|SUPERIORITY||Mean Difference (Final Values)|-155.31|STANDARD_ERROR_OF_MEAN|688.28||0.8227|TWO_SIDED|95.0|-1548.66|1238.04|||Regression, Linear|||Comparison during RCT period||1238.04|-1548.66|0.8227
71881553|NCT02187172|143282275|SUPERIORITY||Mean Difference (Final Values)|-407.43|STANDARD_ERROR_OF_MEAN|180.7||0.0302|TWO_SIDED|95.0|-773.57|-41.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||-41.29|-773.57|0.0302
71881554|NCT02187172|143282276|SUPERIORITY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|-0.47||0.2333|TWO_SIDED|95.0|-1.25|0.32|||Regression, Linear|||Comparison during RCT period||0.32|-1.25|0.2333
71881555|NCT02187172|143282276|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.21||0.0713|TWO_SIDED|95.0|-0.8|0.03|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.03|-0.80|0.0713
71921186|NCT02194699|143363417|SUPERIORITY||Rate ratio|0.39||||0.0576|TWO_SIDED|95.0|0.15|1.03|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.03|0.15|0.0576
71921187|NCT02194699|143363417|SUPERIORITY||Rate ratio|0.83||||0.5249|TWO_SIDED|95.0|0.46|1.48|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."||1.48|0.46|0.5249
71921188|NCT02194699|143363417|SUPERIORITY||Rate ratio|0.67||||0.1155|TWO_SIDED|95.0|0.41|1.1|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.||1.10|0.41|0.1155
71921189|NCT02194699|143363419|SUPERIORITY||LS Mean difference|-0.95||||0.036|TWO_SIDED|95.0|-1.85|-0.06|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||-0.06|-1.85|0.0360
71921190|NCT02194699|143363419|SUPERIORITY||LS Mean difference|0.15||||0.5864|TWO_SIDED|95.0|-0.4|0.7|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||0.70|-0.40|0.5864
71921191|NCT02194699|143363419|SUPERIORITY||LS Mean difference|-0.17||||0.4689|TWO_SIDED|95.0|-0.63|0.29|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||0.29|-0.63|0.4689
71921192|NCT02194699|143363420|SUPERIORITY||LS Mean difference|6.15||||0.5094|TWO_SIDED|95.0|-12.13|24.43|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||24.43|-12.13|0.5094
71922487|NCT00883896|143365379|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.1||||0.986|TWO_SIDED|95.0|-12.3|12.1|||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||12.1|-12.3|0.986
71922488|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
71922489|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.188|TWO_SIDED|95.0|-2.3|7.3|||Cochran-Mantel-Haenszel|||Week 2:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.3|-2.3|0.188
71922490|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 2: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.0|0.0|
71922491|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|1.1||||0.699|TWO_SIDED|95.0|-4.5|6.6|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.6|-4.5|0.699
71922492|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.4||||0.155|TWO_SIDED|95.0|-3.0|13.8|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||13.8|-3.0|0.155
71922493|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.0||||0.546|TWO_SIDED|95.0|-2.9|0.9|||Cochran-Mantel-Haenszel|||Week 4:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||0.9|-2.9|0.546
71881556|NCT02187172|143282277|SUPERIORITY||Mean Difference (Final Values)|-16.87|STANDARD_ERROR_OF_MEAN|15.62||0.2869|TWO_SIDED|95.0|-48.48|14.75|||Regression, Linear|||Comparison during RCT period||14.75|-48.48|0.2869
71881557|NCT02187172|143282277|SUPERIORITY||Mean Difference (Final Values)|-2.23|STANDARD_ERROR_OF_MEAN|1.71||0.1988|TWO_SIDED|95.0|-5.69|1.22|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.22|-5.69|0.1988
71881558|NCT02187172|143282278|SUPERIORITY||Mean Difference (Final Values)|2.06|STANDARD_ERROR_OF_MEAN|12.91||0.8744|TWO_SIDED|95.0|-24.09|28.2|||Regression, Linear|||Comparison during RCT period||28.20|-24.09|0.8744
71881559|NCT02187172|143282278|SUPERIORITY||Mean Difference (Final Values)|10.55|STANDARD_ERROR_OF_MEAN|8.26||0.2093|TWO_SIDED|95.0|-6.18|27.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||27.29|-6.18|0.2093
71881560|NCT02187172|143282279|SUPERIORITY||Mean Difference (Final Values)|19.2|STANDARD_ERROR_OF_MEAN|7.41||0.0135|TWO_SIDED|95.0|4.21|34.2|||Regression, Linear|||Comparison during RCT period||34.20|4.21|0.0135
71881561|NCT02187172|143282279|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|4.14||0.8499|TWO_SIDED|95.0|-9.19|7.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||7.61|-9.19|0.8499
71881562|NCT02187172|143282280|SUPERIORITY||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|1.96||0.0693|TWO_SIDED|95.0|-0.3|7.62|||Regression, Linear|||Comparison during RCT period||7.62|-0.30|0.0693
71881563|NCT02187172|143282280|SUPERIORITY||Mean Difference (Final Values)|1.92|STANDARD_ERROR_OF_MEAN|1.42||0.1841|TWO_SIDED|95.0|-0.96|4.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||4.80|-0.96|0.1841
71881564|NCT02187172|143282281|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|1.03||0.2305|TWO_SIDED|95.0|-0.83|3.34|||Regression, Linear|||Comparison during RCT period||3.34|-0.83|0.2305
71921193|NCT02194699|143363420|SUPERIORITY||LS Mean difference|3.02||||0.5984|TWO_SIDED|95.0|-8.22|14.26|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.26|-8.22|0.5984
71881565|NCT02187172|143282281|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.72||0.2189|TWO_SIDED|95.0|-0.53|2.37|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.37|-0.53|0.2189
71881566|NCT02187172|143282282|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3212|TWO_SIDED|95.0|-0.34|0.11|||Regression, Linear|||Comparison during RCT period||0.11|-0.34|0.3212
71881567|NCT02187172|143282282|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.07||0.0137|TWO_SIDED|95.0|0.04|0.31|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.31|0.04|0.0137
71881568|NCT02187172|143282283|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.6||0.8383|TWO_SIDED|95.0|-1.09|1.33|||Regression, Linear|||Comparison during RCT period||1.33|-1.09|0.8383
71881569|NCT02187172|143282283|SUPERIORITY||Mean Difference (Final Values)|0.51|STANDARD_ERROR_OF_MEAN|0.36||0.1651|TWO_SIDED|95.0|-0.22|1.24|||Regression, Logistic|||Global change from baseline after 52 weeks of active treatment.||1.24|-0.22|0.1651
71881570|NCT02187172|143282284|SUPERIORITY||Mean Difference (Final Values)|2.49|STANDARD_ERROR_OF_MEAN|1.7||0.1502|TWO_SIDED|95.0|-0.94|5.93|||Regression, Linear|||Comparison during RCT period||5.93|-0.94|0.1502
71881571|NCT02187172|143282284|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.84||0.8054|TWO_SIDED|95.0|-1.49|1.91|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||1.91|-1.49|0.8054
71881572|NCT02187172|143282285|SUPERIORITY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|1.69||0.4235|TWO_SIDED|95.0|-4.79|2.05|||Regression, Linear|||Comparison during RCT period||2.05|-4.79|0.4235
71881573|NCT02187172|143282285|SUPERIORITY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.97||0.8653|TWO_SIDED|95.0|-1.8|2.13|||Regression, Linear|||Comparison during RCT period||2.13|-1.80|0.8653
71881574|NCT02187172|143282286|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|1.89||0.558|TWO_SIDED|95.0|-4.95|2.71|||Regression, Linear|||Comparison during RCT period||2.71|-4.95|0.5580
71881575|NCT02187172|143282286|SUPERIORITY||Mean Difference (Final Values)|0.77|STANDARD_ERROR_OF_MEAN|1.0||0.4454|TWO_SIDED|95.0|-1.25|2.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||2.80|-1.25|0.4454
71881576|NCT02187172|143282287|SUPERIORITY||Mean Difference (Final Values)|21.37|STANDARD_ERROR_OF_MEAN|6.67||0.0027|TWO_SIDED|95.0|7.86|34.87|||Regression, Linear|||Comparison during RCT period||34.87|7.86|0.0027
71881577|NCT02187172|143282287|SUPERIORITY||Mean Difference (Final Values)|-2.92|STANDARD_ERROR_OF_MEAN|4.07||0.4775|TWO_SIDED|95.0|-11.17|5.33|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||5.33|-11.17|0.4775
71881578|NCT02187172|143282288|SUPERIORITY||Mean Difference (Final Values)|230.77|STANDARD_ERROR_OF_MEAN|69.8||0.0021|TWO_SIDED|95.0|89.47|372.08|||Regression, Linear|||Comparison during RCT period||372.08|89.47|0.0021
71881579|NCT02187172|143282288|SUPERIORITY||Mean Difference (Final Values)|-31.89|STANDARD_ERROR_OF_MEAN|41.71||0.4493|TWO_SIDED|95.0|-116.4|52.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||52.61|-116.40|0.4493
71921194|NCT02194699|143363420|SUPERIORITY||LS Mean difference|7.84||||0.3971|TWO_SIDED|95.0|-10.32|26.0|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||26.00|-10.32|0.3971
71922494|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
71881580|NCT02187172|143282289|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.17||0.8008|TWO_SIDED|95.0|-0.3|0.38|||Regression, Linear|||Comparison during RCT period||0.38|-0.30|0.8008
71881581|NCT02187172|143282289|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11||0.8068|TWO_SIDED|95.0|-0.19|0.24|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||0.24|-0.19|0.8068
71881582|NCT02187172|143282290|SUPERIORITY||Mean Difference (Final Values)|46.96|STANDARD_ERROR_OF_MEAN|56.12||0.4079|TWO_SIDED|95.0|-66.65|160.57|||Regression, Logistic|||Comparison during RCT period||160.57|-66.65|0.4079
71881583|NCT02187172|143282290|SUPERIORITY||Mean Difference (Final Values)|4.68|STANDARD_ERROR_OF_MEAN|33.85||0.8907|TWO_SIDED|95.0|-63.91|73.28|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||73.28|-63.91|0.8907
71881584|NCT02187172|143282291|SUPERIORITY||Mean Difference (Final Values)|7.01|STANDARD_ERROR_OF_MEAN|48.81||0.8866|TWO_SIDED|95.0|-91.8|105.81|||Regression, Linear|||Comparison during RCT period||105.81|-91.80|0.8866
71881585|NCT02187172|143282291|SUPERIORITY||Mean Difference (Final Values)|-24.74|STANDARD_ERROR_OF_MEAN|32.59||0.4527|TWO_SIDED|95.0|-90.78|41.3|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||41.30|-90.78|0.4527
71881586|NCT02187172|143282292|SUPERIORITY||Mean Difference (Final Values)|194.69|STANDARD_ERROR_OF_MEAN|66.23||0.0056|TWO_SIDED|95.0|60.61|328.77|||Regression, Linear|||Comparison during RCT period||328.77|60.61|0.0056
71881587|NCT02187172|143282292|SUPERIORITY||Mean Difference (Final Values)|-29.16|STANDARD_ERROR_OF_MEAN|38.01||0.4478|TWO_SIDED|95.0|-106.17|47.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.||47.85|-106.17|0.4478
71881588|NCT02187172|143282293|SUPERIORITY||Mean Difference (Final Values)|3.14|STANDARD_ERROR_OF_MEAN|2.81||0.2704|TWO_SIDED|95.0|-2.55|8.83|||Regression, Linear|||Comparison during RCT period||8.83|-2.55|0.2704
71881589|NCT02187172|143282293|SUPERIORITY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|1.41||0.295|TWO_SIDED|95.0|-1.36|4.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.36|-1.36|0.2950
71881590|NCT02187172|143282294|SUPERIORITY||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|6.57||0.0149|TWO_SIDED|95.0|-30.03|-3.45|||Regression, Linear|||Comparison during RCT period||-3.45|-30.03|0.0149
71881591|NCT02187172|143282294|SUPERIORITY||Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|3.37||0.9734|TWO_SIDED|95.0|-6.93|6.71|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.71|-6.93|0.9734
71881592|NCT02187172|143282295|SUPERIORITY||Mean Difference (Net)|-9.21|STANDARD_ERROR_OF_MEAN|11.76||0.4384|TWO_SIDED|95.0|-33.03|14.6|||Regression, Linear|||Comparison during RCT period||14.60|-33.03|0.4384
71881593|NCT02187172|143282295|SUPERIORITY||Mean Difference (Final Values)|11.14|STANDARD_ERROR_OF_MEAN|7.33||0.1373|TWO_SIDED|95.0|-3.72|25.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||25.99|-3.72|0.1373
71881594|NCT02187172|143282296|SUPERIORITY||Mean Difference (Final Values)|-15.71|STANDARD_ERROR_OF_MEAN|5.77||0.0097|TWO_SIDED|95.0|-27.39|-4.03|||Regression, Linear|||Comparison during RCT period||-4.03|-27.39|0.0097
71881595|NCT02187172|143282296|SUPERIORITY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|2.07||0.8119|TWO_SIDED|95.0|-4.69|3.7|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.70|-4.69|0.8119
71881596|NCT02187172|143282297|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|4.57||0.9415|TWO_SIDED|95.0|-8.91|9.59|||Regression, Linear|||Comparison during RCT period||9.59|-8.91|0.9415
71881597|NCT02187172|143282297|SUPERIORITY||Mean Difference (Final Values)|-1.86|STANDARD_ERROR_OF_MEAN|2.43||0.4485|TWO_SIDED|95.0|-6.77|3.06|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||3.06|-6.77|0.4485
71881598|NCT02187172|143282298|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|5.16||0.988|TWO_SIDED|95.0|-10.37|10.53|||Regression, Linear|||Comparison during RCT period||10.53|-10.37|0.9880
71881599|NCT02187172|143282298|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|2.59||0.8836|TWO_SIDED|95.0|-4.86|5.63|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||5.63|-4.86|0.8836
71881600|NCT02187172|143282299|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.3||0.8321|TWO_SIDED|95.0|-2.91|2.36|||Regression, Linear|||Comparison during RCT period||2.36|-2.91|0.8321
71881601|NCT02187172|143282299|SUPERIORITY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|1.08||0.0394|TWO_SIDED|95.0|0.12|4.48|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||4.48|0.12|0.0394
71881602|NCT02187172|143282300|SUPERIORITY||Mean Difference (Final Values)|152.68|STANDARD_ERROR_OF_MEAN|43.76||0.0012|TWO_SIDED|95.0|64.07|241.23|||Regression, Linear|||Comparison during RCT period||241.23|64.07|0.0012
71881603|NCT02187172|143282300|SUPERIORITY||Mean Difference (Final Values)|-2.97|STANDARD_ERROR_OF_MEAN|25.7||0.9085|TWO_SIDED|95.0|-55.04|49.09|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||49.09|-55.04|0.9085
71881604|NCT02187172|143282301|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.04||0.1792|TWO_SIDED|95.0|-0.03|0.14|||Regression, Linear|||Comparison during RCT period||0.14|-0.03|0.1792
71881605|NCT02187172|143282301|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.03||0.2559|TWO_SIDED|95.0|-0.03|0.1|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.10|-0.03|0.2559
71921195|NCT02194699|143363420|SUPERIORITY||LS Mean difference|3.59||||0.531|TWO_SIDED|95.0|-7.65|14.83|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||14.83|-7.65|0.5310
71921196|NCT02194699|143363420|SUPERIORITY||LS Mean difference|3.46||||0.4764|TWO_SIDED|95.0|-6.06|12.97|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||12.97|-6.06|0.4764
71921197|NCT02194699|143363420|SUPERIORITY||LS Mean difference|3.88||||0.4221|TWO_SIDED|95.0|-5.6|13.37|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||13.37|-5.60|0.4221
71921198|NCT02194699|143363421|SUPERIORITY||LS Mean difference|-5.04||||0.1099|TWO_SIDED|95.0|-11.21|1.14|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||1.14|-11.21|0.1099
71921199|NCT02194699|143363421|SUPERIORITY||LS Mean difference|0.46||||0.8112|TWO_SIDED|95.0|-3.33|4.25|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."||4.25|-3.33|0.8112
71921200|NCT02194699|143363421|SUPERIORITY||LS Mean difference|-1.19||||0.4645|TWO_SIDED|95.0|-4.4|2.01|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.||2.01|-4.40|0.4645
71921201|NCT02194699|143363422|SUPERIORITY||Odds Ratio (OR)|0.77||||0.344|TWO_SIDED|95.0|0.44|1.33|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.||1.33|0.44|0.3440
71921202|NCT02194699|143363422|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7768|TWO_SIDED|95.0|0.75|1.46|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.||1.46|0.75|0.7768
71921203|NCT02194699|143363422|SUPERIORITY||Odds Ratio (OR)|0.91||||0.5276|TWO_SIDED|95.0|0.69|1.21|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.||1.21|0.69|0.5276
71921204|NCT04853368|143363430|SUPERIORITY||LS Mean of Difference|2.6|STANDARD_ERROR_OF_MEAN|0.84||0.002|TWO_SIDED|90.0|1.22|4.04||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.04|1.22|0.002
71881606|NCT02187172|143282302|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.13||0.2453|TWO_SIDED|95.0|-0.11|0.41|||Regression, Linear|||||0.41|-0.11|0.2453
71881607|NCT02187172|143282302|SUPERIORITY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.06||0.1087|TWO_SIDED|95.0|-0.02|0.23|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||0.23|-0.02|0.1087
71881608|NCT02187172|143282303|SUPERIORITY||Mean Difference (Final Values)|48.43|STANDARD_ERROR_OF_MEAN|61.62||0.4368|TWO_SIDED|95.0|-76.31|173.16|||Regression, Linear|||Comparison during RCT period||173.16|-76.31|0.4368
71881609|NCT02187172|143282303|SUPERIORITY||Mean Difference (Final Values)|-49.56|STANDARD_ERROR_OF_MEAN|27.84||0.0833|TWO_SIDED|95.0|-105.97|6.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||6.85|-105.97|0.0833
71881610|NCT02187172|143282304|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|1.11||0.8036|TWO_SIDED|95.0|-2.52|1.97|||Regression, Linear|||Comparison during RCT period||1.97|-2.52|0.8036
71881611|NCT02187172|143282304|SUPERIORITY||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|0.51||0.4608|TWO_SIDED|95.0|-0.65|1.4|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.40|-0.65|0.4608
71881612|NCT02187172|143282305|SUPERIORITY||Mean Difference (Final Values)|3320.58|STANDARD_ERROR_OF_MEAN|3414.9||0.337|TWO_SIDED|95.0|-3592.52|10233.67|||Regression, Linear|||Comparison during RCT period||10233.67|-3592.52|0.3370
71881613|NCT02187172|143282305|SUPERIORITY||Mean Difference (Final Values)|6926.25|STANDARD_ERROR_OF_MEAN|2257.84||0.004|TWO_SIDED|95.0|2351.43|11501.07|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||11501.07|2351.43|0.0040
71881614|NCT02187172|143282306|SUPERIORITY||Mean Difference (Final Values)|-68.95|STANDARD_ERROR_OF_MEAN|131.9||0.6042|TWO_SIDED|95.0|-335.97|198.08|||Regression, Linear|||Comparison during RCT period||198.08|-335.97|0.6042
71881615|NCT02187172|143282306|SUPERIORITY||Mean Difference (Final Values)|-7.96|STANDARD_ERROR_OF_MEAN|85.98||0.9267|TWO_SIDED|95.0|-182.18|166.26|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||166.26|-182.18|0.9267
71881616|NCT02187172|143282307|SUPERIORITY||Mean Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|5.18||0.4226|TWO_SIDED|95.0|-6.28|14.68|||Regression, Linear|||Comparison during RCT period||14.68|-6.28|0.4226
71881617|NCT02187172|143282307|SUPERIORITY||Mean Difference (Final Values)|3.41|STANDARD_ERROR_OF_MEAN|3.43||0.327|TWO_SIDED|95.0|-3.54|10.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||10.36|-3.54|0.3270
71881618|NCT02187172|143282308|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|1.52||0.7507|TWO_SIDED|95.0|-3.56|2.59|||Regression, Linear|||Comparison during RCT period||2.59|-3.56|0.7507
71881619|NCT02187172|143282308|SUPERIORITY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.89||0.9348|TWO_SIDED|95.0|-1.88|1.73|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment||1.73|-1.88|0.9348
71881620|NCT02187172|143282309|SUPERIORITY||Difference of proportions|0.67||||0.0005|TWO_SIDED|95.0|0.45|0.89|||Chi-squared|||||0.89|0.45|0.0005
71881621|NCT02187172|143282309|OTHER|95% CI of proportion achieving PASI75 at end of study|Proportion|0.72|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
71881622|NCT02187172|143282310|SUPERIORITY||Difference of proportions|0.41||||0.0016|TWO_SIDED|95.0|0.2|0.62|||Chi-squared|||||0.62|0.20|0.0016
71881623|NCT02187172|143282310|OTHER|95% CI of proportion achieving PASI90 at end of study|Proportion|0.49|||||TWO_SIDED|95.0|0.32|0.65||||||||0.65|0.32|
71881624|NCT02187172|143282311|SUPERIORITY||Difference of proportions|0.53||||0.0005|TWO_SIDED|95.0|0.29|0.78|||Chi-squared|||Comparison during RCT period for binary Physician Global Assessment||0.78|0.29|0.0005
71881625|NCT02187172|143282311|OTHER|95% CI of proportion achieving PGA clear/almost clear at end of study|Proportion|0.46|||||TWO_SIDED|95.0|0.3|0.63||||||||0.63|0.30|
71881626|NCT02187172|143282312|SUPERIORITY||Mean Difference (Final Values)|8.32|STANDARD_ERROR_OF_MEAN|6.3||0.1944|TWO_SIDED|95.0|-4.42|21.06|||Regression, Linear|||||21.06|-4.42|0.1944
71921205|NCT04853368|143363430|SUPERIORITY||LS Mean of Difference|1.3|STANDARD_ERROR_OF_MEAN|1.92||0.254|TWO_SIDED|90.0|-2.07|4.67||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||4.67|-2.07|0.254
71921206|NCT04853368|143363430|SUPERIORITY||LS Mean of Difference|0.9||||0.402|TWO_SIDED|90.0|-5.07|6.77||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Primary analysis of ppFEV1 using MMRM excludes data inconsistent with baseline in terms of the timing of bronchodilator or airway clearance regimen.||||6.77|-5.07|0.402
71921207|NCT04853368|143363432|SUPERIORITY||LS Mean of Difference|5.5|STANDARD_ERROR_OF_MEAN|2.63||0.022|TWO_SIDED|90.0|1.07|9.92||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||9.92|1.07|0.022
71881627|NCT02187172|143282312|SUPERIORITY||Mean Difference (Final Values)|-12.33|STANDARD_ERROR_OF_MEAN|3.5||0.0011|TWO_SIDED|95.0|-19.4|-5.25|||Regression, Linear|||||-5.25|-19.40|0.0011
71921208|NCT04853368|143363432|SUPERIORITY||LS Mean of Difference|-14.1||||0.043|TWO_SIDED|90.0|-27.59|-0.62||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||-0.62|-27.59|0.043
71881628|NCT02187172|143282313|SUPERIORITY||Mean Difference (Final Values)|-779.59|STANDARD_ERROR_OF_MEAN|1049.99||0.4628|TWO_SIDED|95.0|-2911.19|1352.01|||Regression, Linear|||||1352.01|-2911.19|0.4628
71881629|NCT02187172|143282313|SUPERIORITY||Mean Difference (Final Values)|-910.84|STANDARD_ERROR_OF_MEAN|729.96||0.2209|TWO_SIDED|95.0|-2395.95|574.27|||Regression, Linear|||||574.27|-2395.95|0.2209
71881630|NCT04673292|143282314|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing community-based testing to the fixed site SOC testing.|Prevalence Ratio|1.04||||0.67|TWO_SIDED|95.0|0.86|1.27|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.27|0.86|0.67
71881631|NCT04673292|143282314|EQUIVALENCE|The fixed site SOC testing study arm was the standard of care and reference group. The null hypothesis was that there is not a statistically significant difference in the proportion of participants who complete PCR COVID-19 testing within 30 days of randomization when comparing self-collected testing to the fixed site SOC testing.|Prevalence Ratio|1.08||||0.43|TWO_SIDED|95.0|0.89|1.31|||Poisson Regression|Adjusted poisson regression was performed using Study Arm as a nominal variable in the model with the Fixed Site SOC Testing as the reference group.|||Models were adjusted for employment.|1.31|0.89|0.43
71921209|NCT04853368|143363433|SUPERIORITY||LS Mean of Difference|0.14|STANDARD_ERROR_OF_MEAN|0.047||0.003|TWO_SIDED|90.0|0.059|0.219||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.219|0.059|0.003
71921210|NCT04853368|143363433|SUPERIORITY||LS Mean of Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.089||0.475|TWO_SIDED|90.0|-0.162|0.15||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.150|-0.162|0.475
71921211|NCT04853368|143363433|SUPERIORITY||LS Mean of Difference|-0.06||||0.352|TWO_SIDED|90.0|-0.332|0.212||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||Cohort 2: Difference between Triple Therapy and Placebo||0.212|-0.332|0.352
71921212|NCT04853368|143363434|SUPERIORITY||LS Mean of Difference|0.089|STANDARD_ERROR_OF_MEAN|0.0403||0.017|TWO_SIDED|90.0|0.0209|0.1568||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.1568|0.0209|0.017
71921213|NCT04853368|143363434|SUPERIORITY||LS Mean of Difference|0.103|STANDARD_ERROR_OF_MEAN|0.1033||0.169|TWO_SIDED|90.0|-0.1814|0.288||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.2880|-0.1814|0.169
71921214|NCT04853368|143363434|SUPERIORITY||Mean Difference (Final Values)|0.136||||0.23|TWO_SIDED|90.0|-0.1809|0.4527||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|The LS mean is estimated using the mixed-Effect model repeat measurement method.||||0.4527|-0.1809|0.230
71921215|NCT04853368|143363435|SUPERIORITY||LS Mean of Difference|4.4||||0.002|TWO_SIDED|90.0|2.04|6.78||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.78|2.04|0.002
71921216|NCT04853368|143363435|SUPERIORITY||LS Mean of Difference|1.3||||0.35|TWO_SIDED|90.0|-4.42|6.97||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.97|-4.42|0.350
71921217|NCT04853368|143363435|SUPERIORITY||LS Mean of Difference|1.3||||0.412|TWO_SIDED|90.0|-8.75|11.34||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.34|-8.75|0.412
71921218|NCT04853368|143363436|SUPERIORITY||LS Mean of Difference|4.36|||<|0.001|TWO_SIDED|90.0|2.19|6.524||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||6.524|2.190|<0.001
71921219|NCT04853368|143363436|SUPERIORITY||LS Mean of Difference|-0.59||||0.396|TWO_SIDED|90.0|-4.449|3.268||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||3.268|-4.449|0.396
71881632|NCT04673292|143282315|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the community-based testing to fixed site SOC testing. Alpha threshold of 0.05.|Time Ratio|0.87||||0.14|TWO_SIDED|95.0|0.73|1.05||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.05|0.73|0.14
71921220|NCT04853368|143363436|SUPERIORITY||LS Mean of Difference|-2.0||||0.305|TWO_SIDED|90.0|-8.724|4.732||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||4.732|-8.724|0.305
71921221|NCT04853368|143363437|SUPERIORITY||LS Mean of Difference|6.475||||0.018|TWO_SIDED|90.0|1.4443|11.5056||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.5056|1.4443|0.018
71921222|NCT04853368|143363437|SUPERIORITY||LS Mean of Difference|6.019||||0.214|TWO_SIDED|90.0|-7.1464|19.1844||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.1844|-7.1464|0.214
71921223|NCT04853368|143363437|SUPERIORITY||LS Mean of Difference|7.29||||0.286|TWO_SIDED|90.0|-15.186|29.766||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||29.7660|-15.1860|0.286
71921224|NCT04853368|143363438|SUPERIORITY||LS Mean of Difference|5.6||||0.057|TWO_SIDED|90.0|-0.26|11.37||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||11.37|-0.26|0.057
71921225|NCT04853368|143363438|SUPERIORITY||LS Mean of Difference|8.6||||0.088|TWO_SIDED|90.0|-2.18|19.4||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|||||19.40|-2.18|0.088
71921226|NCT04853368|143363438|SUPERIORITY||LS Mean of Difference|11.2||||0.142|TWO_SIDED|90.0|-6.9|29.25||One-sided p-value; p-value \<=0.05 indicates significance.|Mixed Models Analysis|Note: The LS mean is estimated using the linear regression on the change in CFQ-R from baseline to day 29.||||29.25|-6.90|0.142
71921227|NCT04495166|143363444|SUPERIORITY|||||||0.757||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.||||0.757
71921228|NCT04495166|143363445|SUPERIORITY|||||||0.91||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.910
71881633|NCT04673292|143282315|EQUIVALENCE|Testing for equivalence in the difference in time from randomization to completion of SARS-CoV-2 PCR testing when comparing the self-collected testing arm to the fixed site SOC testing Alpha threshold of 0.05.|Time Ratio|0.86||||0.09|TWO_SIDED|95.0|0.71|1.03||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 30 days.|Models adjusted for employment|1.03|0.71|0.09
71881634|NCT04673292|143282316|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the community-based testing to fixed site SOC testing.|Time Ratio|0.96||||0.56|TWO_SIDED|95.0|0.83|1.1||aprior threshold for significance: p\<0.05|Accelerated Failure Time|Study arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.10|0.83|0.56
71881635|NCT04673292|143282316|EQUIVALENCE|Null hypothesis: There is no significant difference in time from completion of SARS-CoV-2 test to receipt of SARS-CoV-2 test results when comparing the self-collected testing arm to the fixed site SOC testing.|Time Ratio|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07||aprior significance threshold: p-value\<0.05|Accelerated Failure Time|Study Arm included as a nominal (dummy) variable in accelerated failure time models. Models adjusted for employment.||Times were censored at 10 days.|Models adjusted for employment|1.07|0.81|0.32
71881636|NCT01438489|143282358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.014|TWO_SIDED|90.0|1.33|4.26|||Regression, Logistic|||All-comers||4.26|1.33|0.014
71881637|NCT01438489|143282358|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.063|TWO_SIDED|90.0|1.08|3.49|||Regression, Logistic|||All-comers||3.49|1.08|0.063
71881638|NCT01438489|143282359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.55||||0.004|TWO_SIDED|90.0|1.72|7.32|||Regression, Logistic|||High||7.32|1.72|0.004
71881639|NCT01438489|143282359|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.029|TWO_SIDED|90.0|1.27|5.53|||Regression, Logistic|||High||5.53|1.27|0.029
71881640|NCT01761084|143282374|SUPERIORITY||Odds Ratio (OR)|1.06|||||TWO_SIDED|95.0|0.58|1.94||||||||1.94|.58|
71881641|NCT01761084|143282375|SUPERIORITY||Risk Ratio (RR)|1.32|||||TWO_SIDED|95.0|0.99|1.74||||||||1.74|.99|
71881642|NCT01761084|143282376|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.811|TWO_SIDED|95.0|-0.84|1.07|||t-test, 2 sided|Intention-to-treat analysis|Intention-to-treat analysis|Baseline||1.07|-0.84|0.811
71881643|NCT01761084|143282376|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.765|TWO_SIDED|95.0|-0.8|1.09|||t-test, 2 sided||Per-protocol analysis|Month 12||1.09|-0.80|0.765
71881644|NCT01761084|143282377|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.796|TWO_SIDED|95.0|-0.8|0.61|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.61|-0.80|0.796
71921229|NCT04495166|143363447|SUPERIORITY|||||||0.442||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.442
71921230|NCT04495166|143363448|SUPERIORITY|||||||0.223||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.223
71921231|NCT04495166|143363449|SUPERIORITY|||||||0.54||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.540
71921232|NCT04495166|143363450|SUPERIORITY|||||||0.901||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.901
71921233|NCT04495166|143363451|SUPERIORITY|||||||0.748||||||Statistical tests were 2-sided and p values \<0.05 were considered statistically significant|t-test, 2 sided|To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.||||||0.748
71881645|NCT01761084|143282377|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.888|TWO_SIDED|95.0|-0.75|0.65|||t-test, 2 sided||Per-protocol analysis|Month 12||0.65|-0.75|0.888
71881646|NCT01761084|143282378|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.719|TWO_SIDED|95.0|-0.54|0.78|||t-test, 2 sided||Intention-to-treat analysis|Baseline||0.78|-0.54|0.719
71881647|NCT01761084|143282378|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.745|TWO_SIDED|95.0|-0.56|0.79|||t-test, 2 sided||Per-protocol analysis|Month 12||0.79|-0.56|0.745
71881648|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.854|TWO_SIDED|95.0|-5.66|6.83|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in EQ5D - VAS||6.83|-5.66|0.854
71881649|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.585|TWO_SIDED|95.0|-4.66|8.22|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in EQ5D-VAS||8.22|-4.66|0.585
71881650|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|0.16||||0.335|TWO_SIDED|95.0|-0.16|0.47|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in OQLQ Average Score||0.47|-0.16|0.335
71881651|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.285|TWO_SIDED|95.0|-0.15|0.5|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in OQLQ Average Score||0.50|-0.15|0.285
71881652|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|-0.52||||0.225|TWO_SIDED|95.0|-1.36|0.32|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS at rest||0.32|-1.36|0.225
71881653|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.488|TWO_SIDED|95.0|-1.16|0.56|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS at rest||0.56|-1.16|0.488
71881654|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.808|TWO_SIDED|95.0|-0.68|0.88|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS during movement||0.88|-0.68|0.808
71921234|NCT02127970|143363461|NON_INFERIORITY|The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.|Difference|-2.9|||||TWO_SIDED|95.0|-8.5|2.8|||||For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.|||2.8|-8.5|
71881655|NCT01761084|143282379|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.566|TWO_SIDED|95.0|-0.57|1.04|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS during movement||1.04|-0.57|0.566
71921235|NCT00542321|143363480|SUPERIORITY_OR_OTHER||difference between proportions|0.5||||1|TWO_SIDED|95.0|||||Fisher Exact|Chi-Square = 0.750, df = 1||Pearson Chi-Square Test for difference between groups||||1.00
71881656|NCT01761084|143282382|SUPERIORITY||Mean Difference (Final Values)|0.045||||0.951|TWO_SIDED|95.0|-1.412|1.501|||t-test, 2 sided|||Baseline||1.501|-1.412|.951
71881657|NCT01761084|143282382|SUPERIORITY||Mean Difference (Final Values)|-1.396||||0.039|TWO_SIDED|95.0|-2.721|-0.071|||t-test, 2 sided|||Month 12||-0.071|-2.721|0.039
71881658|NCT01761084|143282383|SUPERIORITY||Mean Difference (Final Values)|-65.9|||<|0.05|TWO_SIDED|95.0|-91.8|-40.0||Month 6 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-40.0|-91.8|<0.05
71881659|NCT01761084|143282383|SUPERIORITY||Mean Difference (Final Values)|-49.3|||<|0.05|TWO_SIDED|95.0|-69.8|-28.8||Month 12 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.||-28.8|-69.8|<0.05
71881660|NCT01761084|143282388|SUPERIORITY||Incident Rate Ratio|0.97|||||TWO_SIDED|95.0|0.58|1.63||||||Negative Binomial Regression.||1.63|.58|
71881661|NCT01761084|143282391|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.536|TWO_SIDED|95.0|-0.28|0.53|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in height||0.53|-0.28|0.536
71881662|NCT01761084|143282392|SUPERIORITY||Mean Difference (Net)|-0.055||||0.9|TWO_SIDED|95.0|-0.917|0.807|||t-test, 2 sided|||Month 12 scores.||0.807|-0.917|.900
71881663|NCT01761084|143282393|SUPERIORITY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|13.9||0.712|TWO_SIDED|95.0|-33.6|23.2|||t-test, 2 sided|||Baseline||23.2|-33.6|.712
71881664|NCT01761084|143282393|SUPERIORITY||Mean Difference (Final Values)|8.1|STANDARD_ERROR_OF_MEAN|15.3||0.6|TWO_SIDED|95.0|-23.3|39.5|||t-test, 1 sided|||Month 12||39.5|-23.3|.60
71881665|NCT01761084|143282395|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.461|TWO_SIDED|95.0|-0.25|0.55|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in weight||0.55|-0.25|0.461
71881666|NCT01261507|143282396|SUPERIORITY_OR_OTHER||difference in areas under the LROC curve|-0.059|STANDARD_ERROR_OF_MEAN|0.037|<|0.05|TWO_SIDED|95.0|-0.086|-0.031|||mixed model:Dorfman, Berbaum, Metz|||Measure is the difference between the radiologists working without the software less the value for the radiologists working with the software. Thus a negative value would indicate that the the radiologists showed better results when using the software.||-0.031|-0.086|<0.05
71881667|NCT01324232|143282436|SUPERIORITY||Pearson correlation|0.0019|||=|0.9827|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between the change from Baseline PRS scores and the DM plasma concentration was equal to zero and was tested using a 2-sided test at the 5% level of significance within active treatment groups. The regression line was fitted using change from baseline in average PRS during Day 57-84 as the dependent variable and the average of log-transformed DM Plasma Concentration at Day 22 and Day 50 as the independent variable.||||= 0.9827
71881668|NCT01324232|143282438|SUPERIORITY||||||=|0.8869|||||||ANCOVA|||Test of dose trend (overall P value)||||=0.8869
71881669|NCT01324232|143282438|SUPERIORITY||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.46|=|0.9381|TWO_SIDED|95.0|-0.94|0.87|||ANCOVA|||Pairwise treatment group vs placebo||0.87|-0.94|=0.9381
71881670|NCT01324232|143282438|SUPERIORITY||Adjusted mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.46|=|0.4128|TWO_SIDED|95.0|-1.28|0.53|||ANCOVA|||Pairwise treatment group vs placebo||0.53|-1.28|=0.4128
71881671|NCT01324232|143282438|SUPERIORITY||Adjusted mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.461|=|0.9427|TWO_SIDED|95.0|-0.88|0.94|||ANCOVA|||Pairwise treatment group vs placebo||0.94|-0.88|=0.9427
71881672|NCT01324232|143282438|SUPERIORITY||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.401|=|0.6075|TWO_SIDED|95.0|-1.0|0.58|||ANCOVA|||Pairwise treatment group vs placebo||0.58|-1.0|=0.6075
71881673|NCT01324232|143282438|SUPERIORITY||Adjusted mean difference|-0.17|STANDARD_ERROR_OF_MEAN|0.402|=|0.669|TWO_SIDED|95.0|-0.96|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.96|=0.6690
71881674|NCT01324232|143282438|SUPERIORITY||Adjusted mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.38|=|0.7394|TWO_SIDED|95.0|-0.88|0.62|||ANCOVA|||Pairwise treatment group vs placebo||0.62|-0.88|=0.7394
71881675|NCT01324232|143282439|SUPERIORITY||||||=|0.9731|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9731
71881676|NCT01324232|143282439|SUPERIORITY||Mean difference (final values)|1.32|STANDARD_ERROR_OF_MEAN|2.42|||TWO_SIDED|95.0|-3.46|6.09||||||||6.09|-3.46|
71881677|NCT01324232|143282439|SUPERIORITY||Mean difference (final values)|-3.0|STANDARD_ERROR_OF_MEAN|2.394|||TWO_SIDED|95.0|-7.72|1.72||||||||1.72|-7.72|
71881678|NCT01324232|143282439|SUPERIORITY||Mean difference (final values)|1.2|STANDARD_ERROR_OF_MEAN|2.408|||TWO_SIDED|95.0|-3.54|5.95||||||||5.95|-3.54|
71881679|NCT01324232|143282441|SUPERIORITY||||||=|0.4778||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.4778
71881680|NCT01324232|143282441|SUPERIORITY||Adjusted mean difference|0.49|STANDARD_ERROR_OF_MEAN|3.676|||TWO_SIDED|95.0|-6.76|7.74||||||||7.74|-6.76|
71881681|NCT01324232|143282441|SUPERIORITY||Adjusted mean difference|-1.67|STANDARD_ERROR_OF_MEAN|3.663|||TWO_SIDED|95.0|-8.89|5.56||||||||5.56|-8.89|
71881682|NCT01324232|143282441|SUPERIORITY||Adjusted mean difference|3.43|STANDARD_ERROR_OF_MEAN|3.681|||TWO_SIDED|95.0|-3.83|10.68||||||||10.68|-3.83|
71881683|NCT01324232|143282442|SUPERIORITY||||||=|0.0685|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.0685
71881684|NCT01324232|143282442|SUPERIORITY||Mean difference (final values)|-0.51|STANDARD_ERROR_OF_MEAN|0.68|||TWO_SIDED|95.0|-1.85|0.83||||||||0.83|-1.85|
71881685|NCT01324232|143282442|SUPERIORITY||Mean difference (final values)|-0.85|STANDARD_ERROR_OF_MEAN|0.677|||TWO_SIDED|95.0|-2.19|0.48||||||||0.48|-2.19|
71881686|NCT01324232|143282442|SUPERIORITY||Mean difference (final values)|-1.2|STANDARD_ERROR_OF_MEAN|0.681|||TWO_SIDED|95.0|-2.54|0.15||||||||0.15|-2.54|
71881687|NCT01324232|143282443|SUPERIORITY||||||=|0.4201|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.4201
71881688|NCT01324232|143282443|SUPERIORITY||Adjusted mean difference|-0.49|STANDARD_ERROR_OF_MEAN|1.473|||TWO_SIDED|95.0|-3.4|2.41||||||||2.41|-3.40|
71881689|NCT01324232|143282443|SUPERIORITY||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|1.454|||TWO_SIDED|95.0|-3.76|1.97||||||||1.97|-3.76|
71881690|NCT01324232|143282443|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|95.0|-1.42|4.34||||||||4.34|-1.42|
71881691|NCT01324232|143282444|SUPERIORITY||||||=|0.8068||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.||||=0.8068
71881692|NCT01324232|143282444|SUPERIORITY||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.205|||TWO_SIDED|95.0|-3.47|1.28||||||||1.28|-3.47|
71881693|NCT01324232|143282444|SUPERIORITY||Adjusted mean difference|-0.63|STANDARD_ERROR_OF_MEAN|1.2|||TWO_SIDED|95.0|-2.99|1.74||||||||1.74|-2.99|
71881694|NCT01324232|143282444|SUPERIORITY||Adjusted mean difference|0.31|STANDARD_ERROR_OF_MEAN|1.207|||TWO_SIDED|95.0|-2.07|2.69||||||||2.69|-2.07|
71881695|NCT01324232|143282445|SUPERIORITY||||||=|0.6315||||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Oral responses.|ANCOVA|||||||=0.6315
71881696|NCT01324232|143282445|SUPERIORITY||Adjusted mean difference|2.37|STANDARD_ERROR_OF_MEAN|2.772|||TWO_SIDED|95.0|-3.19|7.93||||||||7.93|-3.19|
71881697|NCT01324232|143282445|SUPERIORITY||Adjusted mean difference|1.31|STANDARD_ERROR_OF_MEAN|2.562|||TWO_SIDED|95.0|-3.83|6.45||||||||6.45|-3.83|
71881698|NCT01324232|143282445|SUPERIORITY||Adjusted mean difference|1.46|STANDARD_ERROR_OF_MEAN|2.728|||TWO_SIDED|95.0|-4.01|6.94||||||||6.94|-4.01|
71881699|NCT01324232|143282445|SUPERIORITY||||||=|0.1485|TWO_SIDED|||||P-value presented tests the hypothesis for overall treatment effect versus no treatment effect. Written responses.|ANCOVA|||||||=0.1485
71881700|NCT01324232|143282445|SUPERIORITY||Mean difference (final values)|1.77|STANDARD_ERROR_OF_MEAN|1.558|||TWO_SIDED|95.0|-1.31|4.85||||||||4.85|-1.31|
71881701|NCT01324232|143282445|SUPERIORITY||Mean difference (final values)|-1.68|STANDARD_ERROR_OF_MEAN|1.605|||TWO_SIDED|95.0|-4.86|1.49||||||||1.49|-4.86|
71881702|NCT01324232|143282445|SUPERIORITY||Mean difference (final values)|-1.65|STANDARD_ERROR_OF_MEAN|1.549|||TWO_SIDED|95.0|-4.71|1.41||||||||1.41|-4.71|
71881703|NCT01324232|143282446|SUPERIORITY||||||=|0.1404|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis is that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 158 of the 209 participants in the mITT Population were analyzed at Day 22.||||=0.1404
71881704|NCT01324232|143282446|SUPERIORITY||||||=|0.0805|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 152 of the 209 participants in the mITT Population were analyzed at Day 50.||||=0.0805
71881705|NCT01324232|143282446|SUPERIORITY||||||=|0.0551|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis that the true correlation between NRS scores and DM plasma concentration is equal to zero. Only 185 of the 209 participants in the mITT Population were analyzed at Day 85.||||=0.0551
71881706|NCT01324232|143282447|SUPERIORITY||||||=|0.9207|TWO_SIDED|||||The p-value presented tests the hypothesis for overall treatment effect versus no treatment effect.|ANCOVA|||||||=0.9207
71881707|NCT00705783|143282477|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.199|||<|0.0001|TWO_SIDED|95.0|0.125|0.317|||Log Rank||Aripiprazole depot/placebo depot|Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.||0.317|0.125|<0.0001
71881708|NCT00705783|143282478|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.|Chi-squared|||||||<0.0001
71881709|NCT00705783|143282479|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71881710|NCT00705783|143282480|SUPERIORITY_OR_OTHER|||||||0.1756||95.0|||||Chi-squared|||||||0.1756
71881711|NCT00705783|143282481|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.11|||<|0.0001|TWO_SIDED|95.0|-12.68|-7.54|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-7.54|-12.68|<0.0001
71881712|NCT00705783|143282482|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.7|-0.35|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.35|-0.70|<0.0001
71881713|NCT00705783|143282483|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.82|||<|0.0001|TWO_SIDED|95.0|-4.72|-2.91|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||Positive Subscale Score||-2.91|-4.72|<0.0001
71881714|NCT00705783|143282484|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0001|TWO_SIDED|95.0|-2.04|-0.67|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||||-0.67|-2.04|0.0001
71881715|NCT00705783|143282485|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71881716|NCT00705783|143282486|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
71881717|NCT02184195|143282487|SUPERIORITY||Hazard Ratio (HR)|0.531||||0.0038|TWO_SIDED|95.0|0.346|0.815|||Log-rank test|||||0.815|0.346|0.0038
71881718|NCT02184195|143282488|OTHER||Hazard Ratio (HR)|0.831||||0.3487|TWO_SIDED|95.0|0.564|1.224|||Log-rank test|||||1.224|0.564|0.3487
71881719|NCT02184195|143282489|SUPERIORITY||Hazard Ratio (HR)|0.659||||0.0613|TWO_SIDED|95.0|0.426|1.02|||Log-rank test|||||1.020|0.426|0.0613
71881720|NCT02184195|143282490|SUPERIORITY||Hazard Ratio (HR)|0.611||||0.0111|TWO_SIDED|95.0|0.418|0.894|||Log-rank test|||||0.894|0.418|0.0111
71881721|NCT02184195|143282491|SUPERIORITY||Hazard Ratio (HR)|0.442|||<|0.0001|TWO_SIDED|95.0|0.297|0.658|||Log-rank test|||||0.658|0.297|<0.0001
71881722|NCT02184195|143282492|SUPERIORITY||Hazard Ratio (HR)|0.425|||<|0.0001|TWO_SIDED|95.0|0.289|0.627|||Log-rank test|||||0.627|0.289|<0.0001
71881723|NCT02184195|143282493|SUPERIORITY||Odds Ratio (OR)|1.52||||0.3273|TWO_SIDED|95.0|0.668|3.61|||Regression, Logistic|||||3.610|0.668|0.3273
71881724|NCT02184195|143282495|SUPERIORITY||Mean Difference (Final Values)|-2.21||||0.355|TWO_SIDED|95.0|-6.917|2.496|||Mixed Models Analysis|||||2.496|-6.917|0.355
71881725|NCT02997735|143282500|SUPERIORITY||Odds Ratio (OR)|7.78|||<|0.001|TWO_SIDED|95.0|2.81|27.9|||Chi-squared||ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.|||27.90|2.81|<0.001
71881726|NCT02997735|143282501|SUPERIORITY||Odds Ratio (OR)|0.48||||0.15|TWO_SIDED|95.0|0.13|1.72|||Chi-squared||1-5 years Row (\<1 Ref)|||1.72|0.13|0.15
71881727|NCT02997735|143282501|SUPERIORITY||Odds Ratio (OR)|0.61|||||TWO_SIDED|95.0|0.18|2.12|||||6-12 years Row (\<1 Ref)|||2.12|0.18|
71881728|NCT02997735|143282501|SUPERIORITY||Odds Ratio (OR)|1.82|||||TWO_SIDED|95.0|0.49|6.94|||||13 or Older Row (\<1 Ref)|||6.94|0.49|
71881729|NCT02997735|143282502|SUPERIORITY||Odds Ratio (OR)|2.38||||0.028|TWO_SIDED|95.0|0.92|6.5|||Chi-squared||35-49 years Row (18-34 Ref)|||6.50|0.92|0.028
71881730|NCT02997735|143282502|SUPERIORITY||Odds Ratio (OR)|5.1|||||TWO_SIDED|95.0|1.46|17.32|||||50 or older Row (18-34 Ref)|||17.32|1.46|
71881731|NCT02997735|143282503|SUPERIORITY||Odds Ratio (OR)|1.1||||0.85|TWO_SIDED|95.0|0.4|2.8|||Chi-squared||Asthma Row (No asthma Ref)|||2.80|0.40|0.85
71881732|NCT02997735|143282504|SUPERIORITY||Odds Ratio (OR)|2.07||||0.086|TWO_SIDED|95.0|0.9|6.5|||Chi-squared||10 or more cigarettes Row (\<10 cigarettes Ref)|||6.50|0.90|0.086
71881733|NCT02997735|143282505|SUPERIORITY||Odds Ratio (OR)|0.47||||0.35|TWO_SIDED|95.0|0.15|1.27|||Chi-squared||Less than 6 months Row (30 days Ref)|||1.27|0.15|0.35
71881734|NCT02997735|143282505|SUPERIORITY||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.15|2.21|||||||6 or more months Row (30 days Ref)|2.21|0.15|
71881735|NCT03029143|143282506|OTHER||Odds Ratio (OR)|0.6|||=|0.401|TWO_SIDED|95.0|0.2|1.8|||Chi-squared||||Chi-squared test was used to estimate P-value from the logistic regression model where Endoscopic Mucosal Healing was the response variable and Treatment and TNF stratification were factors. Baseline complete Mayo Score and natural logarithm of trough concentration at week 6 were covariates.|1.8|0.2|=0.401
71881736|NCT03029143|143282507|OTHER||Adjusted risk difference|-0.4|||=|0.943|TWO_SIDED|95.0|-11.4|10.6|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|10.6|-11.4|=0.943
71881737|NCT03029143|143282508|OTHER||Adjusted risk difference|-1.2|||=|0.893|TWO_SIDED|95.0|-18.7|16.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|16.3|-18.7|=0.893
71881738|NCT03029143|143282509|OTHER||Adjusted risk difference|6.0|||=|0.525|TWO_SIDED|95.0|-12.4|24.3|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.3|-12.4|=0.525
71881739|NCT03029143|143282510|OTHER||Adjusted risk difference|-6.6|||=|0.623|TWO_SIDED|95.0|-34.0|20.8|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|20.8|-34.0|=0.623
71881740|NCT03029143|143282511|SUPERIORITY||Adjusted risk difference|8.1|||=|0.344|TWO_SIDED|95.0|-8.5|24.7|||CMH Chi-square test||||Cochran-Mantel-Haenszel (CMH) chi-square test was stratified by TNF antagonist status.|24.7|-8.5|=0.344
71881741|NCT00619255|143282525|SUPERIORITY||Slope|1.38||||0.71|TWO_SIDED||||||Chi-squared|DF=3||||||0.71
71881742|NCT00619255|143282526|SUPERIORITY||Slope|1.02||||0.8|TWO_SIDED||||||Chi-squared|DF=3||||||0.80
71881743|NCT00619255|143282527|SUPERIORITY|||||||0.67|||||||Chi-squared|"DF = 1~Chi-Square Value = 0.18"||||||0.67
71881744|NCT00619255|143282528|SUPERIORITY||Slope|9.0||||0.03|TWO_SIDED||||||Chi-squared|DF=3||||||0.03
71881745|NCT00619255|143282529|SUPERIORITY||Slope|1.35||||0.72|TWO_SIDED||||||Chi-squared|DF=3||||||0.72
71881746|NCT02121262|143282530|SUPERIORITY||Rate Difference|1.5||||0.7431|TWO_SIDED|95.0|-5.9|8.9|||Cochran-Mantel-Haenszel|Based on the Cochran-Mantel-Haenszel (CMH) general association test stratified by baseline BCVA categories.||||8.9|-5.9|0.7431
71881747|NCT02121262|143282531|SUPERIORITY||Least Squares Mean (LSM) Difference|2.9|STANDARD_ERROR_OF_MEAN|0.89||0.0011|TWO_SIDED|95.0|1.17|4.66|||ANCOVA|The ANCOVA model included the treatment group as the main effect and baseline BCVA score as the covariate.|Null hypothesis-there was no difference in treatment groups of average BCVA CFB in 12-months. Hypothesis test-based on 2-sided test at 0.05 significance level,confidence interval(CI) was constructed between treatment groups in LSM using ANCOVA model.|||4.66|1.17|0.0011
71881748|NCT02121262|143282532|SUPERIORITY||Least Squares Mean Difference|-89.3|STANDARD_ERROR_OF_MEAN|16.89|<|0.0001|TWO_SIDED|95.0|-122.53|-56.01|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline retinal thickness as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-56.01|-122.53|<0.0001
71881749|NCT02121262|143282533|SUPERIORITY||Least Squares Mean Difference|-7.729|STANDARD_ERROR_OF_MEAN|1.0443|<|0.0001|TWO_SIDED|95.0|-9.7855|-5.6733|||ANCOVA|Based on ANCOVA model with treatment and baseline BCVA categories as main effects and baseline total leakage area as the covariate.|Null hypothesis was there was no difference in treatment groups in average BCVA CFB in 12-months. Hypothesis test was based on 2-sided test at 0.05 significance level. 2-sided 95% CI was constructed between treatment groups in LSM using ANCOVA model.|||-5.6733|-9.7855|<0.0001
71881750|NCT02255409|143282575|OTHER||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-6.7|9.7||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||9.7|-6.7|
71881751|NCT02255409|143282575|OTHER||Mean Difference (Final Values)|-6.0|||||TWO_SIDED|95.0|-14.2|2.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||2.3|-14.2|
71881752|NCT02255409|143282575|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|8.4|24.1||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||24.1|8.4|
71921236|NCT00542321|143363481|SUPERIORITY_OR_OTHER||Rank sums|52.0||||1|TWO_SIDED|95.0||||Alpha = .05|Wilcoxon (Mann-Whitney)|||There will be no difference in duration of mechanical ventilation between groups.||||1.0
71921237|NCT00542321|143363482|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.451
71921238|NCT00542321|143363483|SUPERIORITY_OR_OTHER||probability|0.43||||1||95.0|||||Fisher Exact|||||||1.0
71881753|NCT02255409|143282575|OTHER||Mean Difference (Final Values)|14.2|||||TWO_SIDED|95.0|6.3|22.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||22.0|6.3|
71881754|NCT02255409|143282576|OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.9|2.2||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22||2.2|-0.9|
71881755|NCT02255409|143282576|OTHER||Mean Difference (Final Values)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22||1.2|-1.9|
71881756|NCT02255409|143282576|OTHER||Mean Difference (Final Values)|14.4|||||TWO_SIDED|95.0|9.3|20.0||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22||20.0|9.3|
71881757|NCT02255409|143282576|OTHER||Mean Difference (Final Values)|26.0|||||TWO_SIDED|95.0|20.6|32.0||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22||32.0|20.6|
71881758|NCT02255409|143282580|OTHER||Mean Difference (Final Values)|5.8|||||TWO_SIDED|95.0|-1.6|13.0||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||13.0|-1.6|
71881759|NCT02255409|143282580|OTHER||Mean Difference (Final Values)|2.2|||||TWO_SIDED|95.0|-5.5|9.8||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.8|-5.5|
71881760|NCT02255409|143282580|OTHER||Mean Difference (Final Values)|11.8|||||TWO_SIDED|95.0|5.3|18.3||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||18.3|5.3|
71881761|NCT02255409|143282580|OTHER||Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-8.4|5.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||5.7|-8.4|
71881762|NCT02255409|143282581|OTHER||Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|2.4|8.4||||||Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181||8.4|2.4|
71921239|NCT00542321|143363484|SUPERIORITY_OR_OTHER||Rank sums|56.0||||1|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0
71921240|NCT04542525|143363498|SUPERIORITY||||||<|0.0001|||||||Exact Test of Binomial Proportion||||P-value is provided from exact test of binomial proportion (one-sided alpha = 2.5%) comparing PanOptix Toric Trifocal IOL Model TFNT20 with historical threshold 29.2 % (rate calculated for a non-toric IOL in Japanese study patients that would qualify for a T2 lens using the same toric calculator).|||<0.0001
71921241|NCT00545740|143363501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.063||95.0|||||Cochran-Mantel-Haenszel|||||||0.063
71921242|NCT00545740|143363501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.736||95.0|||||Cochran-Mantel-Haenszel|||||||0.736
71921243|NCT00545740|143363501|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
71921244|NCT00545740|143363503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0|||||Cochran-Mantel-Haenszel|||||||0.047
71921245|NCT00545740|143363503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741||95.0|||||Cochran-Mantel-Haenszel|||||||0.741
71921246|NCT00545740|143363503|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78||95.0|||||Cochran-Mantel-Haenszel|||||||0.780
71688240|NCT03372382|142892414|EQUIVALENCE|We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it's 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments|Mean Difference (Final Values)|4.8|||||TWO_SIDED|95.0|-2.1|11.9|||||The upper boundary of the CI is out of pre-specified limits.|Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.||11.9|-2.1|
71688241|NCT02757352|142892416|SUPERIORITY||Odds Ratio (OR)|2.36||||0.009|TWO_SIDED|95.0|1.23|4.51|||Regression, Logistic|||||4.51|1.23|0.009
71688242|NCT02757352|142892416|SUPERIORITY||Odds Ratio (OR)|2.78||||0.002|TWO_SIDED|95.0|1.48|5.25|||Regression, Logistic|||||5.25|1.48|0.002
71688243|NCT02757352|142892417|SUPERIORITY||Odds Ratio (OR)|2.82||||0.004|TWO_SIDED|95.0|1.38|5.77|||Regression, Logistic|||||5.77|1.38|0.004
71688244|NCT02757352|142892417|SUPERIORITY||Odds Ratio (OR)|2.85||||0.004|TWO_SIDED|95.0|1.4|5.77|||Regression, Logistic|||||5.77|1.40|0.004
71881763|NCT02255409|143282581|OTHER||Mean Difference (Final Values)|5.6|||||TWO_SIDED|95.0|3.1|9.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||9.3|3.1|
71921247|NCT01234337|143363509|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.973|||=|0.405618|TWO_SIDED|95.0|0.779|1.217||One-sided p-value from log rank test (stratified per randomization as in interactive voice response system \[IVRS\]).|Log Rank|||PFS was compared using a stratified log-rank test with a one-sided alpha of 0.005, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95 percent (%) CIs were calculated using the Cox model, stratified by the above factors. A Hazard ratio of less than (\<) 1 indicates superiority of Sorafenib + Capecitabine over Placebo + Capecitabine.||1.217|0.779|=0.405618
71921248|NCT01234337|143363510|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.195|||=|0.930088|TWO_SIDED|95.0|0.943|1.513||One-sided p-value from log rank test (stratified per randomization as in IVRS). OS was compared using a stratified log-rank test, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease.|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by randomization factors.|At the time of PFS final analysis, it was OS interim analysis (IA) with 285 total death events. According to protocol specified O'Brien-Fleming type alpha spending function and 285 death events at IA, the prespecified alpha for this analysis was 0.0075 (one-sided). A Hazard ratio \< 1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.513|0.943|=0.930088
71921249|NCT01234337|143363511|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||=|0.2105|TWO_SIDED|95.0|0.723|1.146||One-sided p-value from log rank test (stratified per randomization as in IVRS).|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by the above factors.|TTP was compared using a stratified log-rank test with a one-sided alpha of 0.025, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. A Hazard ratio \<1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.||1.146|0.723|=0.2105
71921250|NCT01234337|143363512|SUPERIORITY_OR_OTHER||Percent Difference|1.93|||=|0.257412|TWO_SIDED|95.0|-3.9|7.77||One-sided p-value from Cochran Mantel-Haenszel test (stratified per randomization as in IVRS)|Cochran-Mantel-Haenszel|||ORR and 95% CI based on Cochran Mantel-Haenszel Test stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. Difference = (Placebo + Capecitabine) - (Sorafenib + Capecitabine).||7.77|-3.9|=0.257412
71881764|NCT02255409|143282581|OTHER||Mean Difference (Final Values)|33.2|||||TWO_SIDED|95.0|25.0|40.9||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||40.9|25.0|
71881765|NCT02255409|143282581|OTHER||Mean Difference (Final Values)|37.3|||||TWO_SIDED|95.0|29.6|44.7||||||Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181||44.7|29.6|
71881766|NCT02255409|143282582|OTHER||GMT Ratio|1.94|||||TWO_SIDED|95.0|1.6|2.4||||||The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 1.||2.4|1.6|
71881767|NCT02255409|143282582|OTHER||GMT Ratio|1.48|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 22.||1.7|1.3|
71881768|NCT02255409|143282582|OTHER||GMT Ratio|1.5|||||TWO_SIDED|95.0|1.3|1.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H1N1 at Day 181.||1.7|1.3|
71881769|NCT02255409|143282582|OTHER||GMT Ratio|2.16|||||TWO_SIDED|95.0|1.7|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||2.7|1.7|
71688245|NCT02757352|142892418|SUPERIORITY||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.136|<|0.001|TWO_SIDED|95.0|-0.81|-0.28|||Mixed Models Analysis|||||-0.28|-0.81|<0.001
71688246|NCT02757352|142892418|SUPERIORITY||LS Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.134|<|0.001|TWO_SIDED|95.0|-0.94|-0.41|||Mixed Models Analysis|||||-0.41|-0.94|<0.001
71688247|NCT02757352|142892419|SUPERIORITY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.179|<|0.001|TWO_SIDED|95.0|-0.96|-0.26|||Mixed Models Analysis|||||-0.26|-0.96|<0.001
71688248|NCT02757352|142892419|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.178|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||Mixed Models Analysis|||||-0.34|-1.05|<0.001
71688249|NCT02757352|142892421|SUPERIORITY||LS Mean Difference|2.8509|STANDARD_ERROR_OF_MEAN|1.139||0.013|TWO_SIDED|95.0|0.6092|5.0926|||Mixed Models Analysis|||||5.0926|0.6092|0.013
71688250|NCT02757352|142892421|SUPERIORITY||LS Mean Difference|2.7497|STANDARD_ERROR_OF_MEAN|1.1278||0.015|TWO_SIDED|95.0|0.5299|4.9694|||Mixed Models Analysis|||||4.9694|0.5299|0.015
71688251|NCT02757352|142892422|SUPERIORITY||LS Mean Difference|4.2001|STANDARD_ERROR_OF_MEAN|1.6467||0.012|TWO_SIDED|95.0|0.9525|7.4477|||Mixed Models Analysis|||||7.4477|0.9525|0.012
71688252|NCT02757352|142892422|SUPERIORITY||LS Mean Difference|4.6081|STANDARD_ERROR_OF_MEAN|1.6455||0.006|TWO_SIDED|95.0|1.3629|7.8533|||Mixed Models Analysis|||||7.8533|1.3629|0.006
71688253|NCT02757352|142892423|SUPERIORITY||Odds Ratio (OR)|2.73||||0.008|TWO_SIDED|95.0|1.3|5.76|||Regression, Logistic|||||5.76|1.30|0.008
71688254|NCT02757352|142892423|SUPERIORITY||Odds Ratio (OR)|3.43|||<|0.001|TWO_SIDED|95.0|1.66|7.08|||Regression, Logistic|||||7.08|1.66|<0.001
71688255|NCT02757352|142892424|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.02|10.41|||Regression, Logistic|||||10.41|2.02|<0.001
71688256|NCT02757352|142892424|SUPERIORITY||Odds Ratio (OR)|3.99|||<|0.001|TWO_SIDED|95.0|1.76|9.05|||Regression, Logistic|||||9.05|1.76|<0.001
71688257|NCT02757352|142892425|SUPERIORITY||LS Means Square Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.308||0.031|TWO_SIDED|95.0|-1.28|-0.06|||Mixed Models Analysis|||||-0.06|-1.28|0.031
71688258|NCT02757352|142892425|SUPERIORITY||LS Mean Difference|-1.01|STANDARD_ERROR_OF_MEAN|0.305||0.001|TWO_SIDED|95.0|-1.61|-0.41|||Mixed Models Analysis|||||-0.41|-1.61|0.001
71688259|NCT02757352|142892426|SUPERIORITY||LS Mean Difference|-1.13|STANDARD_ERROR_OF_MEAN|0.404||0.006|TWO_SIDED|95.0|-1.92|-0.33|||Mixed Models Analysis|||||-0.33|-1.92|0.006
71688260|NCT02757352|142892426|SUPERIORITY||LS Mean Difference|-1.29|STANDARD_ERROR_OF_MEAN|0.404||0.002|TWO_SIDED|95.0|-2.08|-0.49|||Mixed Models Analysis|||||-0.49|-2.08|0.002
71688261|NCT02757352|142892427|SUPERIORITY||LS Mean Difference|-3.07|STANDARD_ERROR_OF_MEAN|0.764|<|0.001|TWO_SIDED|95.0|-4.58|-1.57|||ANCOVA|||||-1.57|-4.58|<0.001
71688262|NCT02757352|142892427|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|0.751|<|0.001|TWO_SIDED|95.0|-5.68|-2.72|||ANCOVA|||||-2.72|-5.68|<0.001
71921251|NCT01234337|143363513|SUPERIORITY_OR_OTHER||Percent Difference|-2.34|||=|0.284674|TWO_SIDED|95.0|-10.4|5.72||One-sided p-value from Cochran-Mantel-Haenszel test (stratified per randomization as in IVRS).|Cochran-Mantel-Haenszel|||"DCR and 95% CI based on general association Cochran-Mantel-Haenszel statistic with one-sided alpha of 0.025 stratified by number of prior chemotherapies for metastatic disease, hormone receptor status, and region. Difference = Placebo + Capecitabine - Sorafenib + Capecitabine."||5.72|-10.4|=0.284674
71921252|NCT01234337|143363515|SUPERIORITY_OR_OTHER||LSM Difference|-0.441|||||TWO_SIDED|95.0|-0.967|0.086||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.086|-0.967|
71688263|NCT02757352|142892428|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.621||0.849|TWO_SIDED|95.0|-1.35|1.11|||Mixed Models Analysis|||||1.11|-1.35|0.849
71688264|NCT02757352|142892428|SUPERIORITY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.608||0.648|TWO_SIDED|95.0|-1.48|0.93|||Mixed Models Analysis|||||0.93|-1.48|0.648
71688265|NCT02757352|142892429|SUPERIORITY||LS Mean Difference|-1.06|STANDARD_ERROR_OF_MEAN|0.443||0.018|TWO_SIDED|95.0|-1.93|-0.18|||Mixed Models Analysis|||||-0.18|-1.93|0.018
71688266|NCT02757352|142892429|SUPERIORITY||LS Mean Difference|-1.18|STANDARD_ERROR_OF_MEAN|0.442||0.008|TWO_SIDED|95.0|-2.05|-0.31|||Mixed Models Analysis|||||-0.31|-2.05|0.008
71688267|NCT02757352|142892430|SUPERIORITY||Odds Ratio (OR)|5.33||||0.0011|TWO_SIDED|96.0|1.47|19.4|||Regression, Logistic|||||19.40|1.47|0.0011
71688268|NCT02757352|142892430|SUPERIORITY||Odds Ratio (OR)|4.22||||0.031|TWO_SIDED|95.0|1.14|15.66|||Regression, Logistic|||||15.66|1.14|0.031
71688269|NCT02757352|142892431|SUPERIORITY||LS Mean Difference|-3.807|STANDARD_ERROR_OF_MEAN|2.8507||0.183|TWO_SIDED|95.0|-9.418|1.804|||Mixed Models Analysis|||||1.804|-9.418|0.183
71688270|NCT02757352|142892431|SUPERIORITY||LS Mean Difference|-2.743|STANDARD_ERROR_OF_MEAN|2.8202||0.331|TWO_SIDED|95.0|-8.294|2.807|||Mixed Models Analysis|||||2.807|-8.294|0.331
71688271|NCT02757352|142892432|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.148||0.008|TWO_SIDED|95.0|-0.69|-0.1|||Mixed Models Analysis|||||-0.10|-0.69|0.008
71688272|NCT02757352|142892432|SUPERIORITY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.148||0.038|TWO_SIDED|95.0|-0.6|-0.02|||Mixed Models Analysis|||||-0.02|-0.60|0.038
71688273|NCT02757352|142892433|SUPERIORITY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.325||0.871|TWO_SIDED|95.0|-0.59|0.7|||Mixed Models Analysis|||||0.70|-0.59|0.871
71688274|NCT02757352|142892433|SUPERIORITY||LS Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.327||0.295|TWO_SIDED|95.0|-0.3|0.99|||Mixed Models Analysis|||||0.99|-0.30|0.295
71688275|NCT02757352|142892434|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.406||0.257|TWO_SIDED|95.0|-1.26|0.34|||Mixed Models Analysis|||||0.34|-1.26|0.257
71688276|NCT02757352|142892434|SUPERIORITY||LS Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.402||0.057|TWO_SIDED|95.0|-1.56|0.02|||Mixed Models Analysis|||||0.02|-1.56|0.057
71688277|NCT02757352|142892435|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.496||0.082|TWO_SIDED|95.0|-1.85|0.11|||Mixed Models Analysis|||||0.11|-1.85|0.082
71688278|NCT02757352|142892435|SUPERIORITY||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.493||0.088|TWO_SIDED|95.0|-1.82|0.13|||Mixed Models Analysis|||||0.13|-1.82|0.088
71688279|NCT02757352|142892436|SUPERIORITY||LS Mean Difference|-1.79|STANDARD_ERROR_OF_MEAN|1.442||0.219|TWO_SIDED|95.0|-4.66|1.09|||Mixed Models Analysis|||TJC||1.09|-4.66|0.219
71688280|NCT02757352|142892436|SUPERIORITY||LS Mean Difference|-3.53|STANDARD_ERROR_OF_MEAN|1.388||0.013|TWO_SIDED|95.0|-6.3|-0.76|||Mixed Models Analysis|||TJC||-0.76|-6.30|0.013
71688281|NCT02757352|142892436|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.355||0.009|TWO_SIDED|95.0|-1.68|-0.26|||Mixed Models Analysis|||SJC||-0.26|-1.68|0.009
71688282|NCT02757352|142892436|SUPERIORITY||LS Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.348||0.034|TWO_SIDED|95.0|-1.46|-0.06|||Mixed Models Analysis|||SJC||-0.06|-1.46|0.034
71688283|NCT02757352|142892438|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.5||0.325|TWO_SIDED|95.0|-1.5|0.5|||Mixed Models Analysis|||||0.5|-1.5|0.325
71688284|NCT02757352|142892438|SUPERIORITY||LS Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.5||0.206|TWO_SIDED|95.0|-1.6|0.4|||Mixed Models Analysis|||||0.4|-1.6|0.206
71688285|NCT02757352|142892439|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.601||0.33|TWO_SIDED|95.0|-1.77|0.6|||Mixed Models Analysis|||||0.60|-1.77|0.330
71688286|NCT02757352|142892439|SUPERIORITY||LS Mean Difference|-0.97|STANDARD_ERROR_OF_MEAN|0.602||0.11|TWO_SIDED|95.0|-2.15|0.22|||Mixed Models Analysis|||||0.22|-2.15|0.110
71688287|NCT02757352|142892440|SUPERIORITY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.81||0.348|TWO_SIDED|95.0|-2.4|0.8|||Mixed Models Analysis|||||0.8|-2.4|0.348
71688288|NCT02757352|142892440|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.82||0.386|TWO_SIDED|95.0|-2.3|0.9|||Mixed Models Analysis|||||0.9|-2.3|0.386
71688289|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-13.76|STANDARD_ERROR_OF_MEAN|4.835||0.005|TWO_SIDED|95.0|-23.32|-4.2|||ANCOVA|||Overall Impairment Score||-4.20|-23.32|0.005
71688290|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-6.29|STANDARD_ERROR_OF_MEAN|4.697||0.183|TWO_SIDED|95.0|-15.58|3.0|||ANCOVA|||Overall Impairment Score||3.00|-15.58|0.183
71688291|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|3.114||0.06|TWO_SIDED|95.0|-12.05|0.26|||ANCOVA|||Percentage of absenteeism||0.26|-12.05|0.060
71688292|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-4.15|STANDARD_ERROR_OF_MEAN|3.098||0.182|TWO_SIDED|95.0|-10.27|1.97|||ANCOVA|||Percentage of absenteeism||1.97|-10.27|0.182
71688293|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-13.61|STANDARD_ERROR_OF_MEAN|4.558||0.003|TWO_SIDED|95.0|-22.62|-4.6|||ANCOVA|||Percentage of presentism||-4.60|-22.62|0.003
71688294|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-6.21|STANDARD_ERROR_OF_MEAN|4.446||0.164|TWO_SIDED|95.0|-15.0|2.58|||ANCOVA|||Percentage of presentism||2.58|-15.00|0.164
71688295|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-10.63|STANDARD_ERROR_OF_MEAN|3.669||0.004|TWO_SIDED|95.0|-17.85|-3.41|||LS Mean Difference|||Percentage of Impairment in Activities Performed Outside of Work||-3.41|-17.85|0.004
71688296|NCT02757352|142892441|SUPERIORITY||LS Mean Difference|-9.99|STANDARD_ERROR_OF_MEAN|3.621||0.006|TWO_SIDED|95.0|-17.12|-2.86|||ANCOVA|||Percentage of Impairment in Activities Performed Outside of Work||-2.86|-17.12|0.006
71688297|NCT00802672|142892445|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|For the primary efficacy analysis, a 90% confidence interval was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald's method with Yates' continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)|Mean Difference (Final Values)|1.0|||||TWO_SIDED|90.0|-17.61|2.45|||Wald's method with Yates' continuity|||||2.45|-17.61|
71688298|NCT01579669|142892481|SUPERIORITY_OR_OTHER|||||||0.0269|TWO_SIDED||||||t-test, 2 sided|||Pre-post comparison||||0.0269
71688299|NCT01579669|142892482|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||<0.0001
71688300|NCT01579669|142892483|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||Pre-post intervention comparison||||0.016
71688301|NCT00527124|142892484|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.907|STANDARD_ERROR_OF_MEAN|0.2973||0.7428|TWO_SIDED|95.0|0.506|1.624|||Regression, Cox|||||1.624|0.506|0.7428
71688302|NCT00527124|142892484|SUPERIORITY_OR_OTHER|||||||0.7425|TWO_SIDED|95.0|||||Log Rank|||||||0.7425
71688303|NCT01301079|142892499|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Mann-Whitney|||||||0.113
71688304|NCT01301079|142892500|SUPERIORITY_OR_OTHER|||||||0.946|TWO_SIDED||||||t-test, 2 sided|||||||0.946
71688305|NCT01301079|142892501|SUPERIORITY_OR_OTHER|||||||0.999|TWO_SIDED||||||t-test, 2 sided|||||||0.999
71688306|NCT01301079|142892502|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||t-test, 2 sided|||||||0.019
71688307|NCT01301079|142892503|SUPERIORITY_OR_OTHER|||||||0.652|TWO_SIDED||||||t-test, 2 sided|||||||0.652
71688308|NCT01301079|142892504|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED||||||t-test, 2 sided|||||||0.221
71688309|NCT01301079|142892505|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
71688310|NCT01301079|142892506|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED||||||t-test, 2 sided|||||||0.386
71688311|NCT01301079|142892507|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||t-test, 1 sided|||||||0.499
71688312|NCT01301079|142892508|SUPERIORITY_OR_OTHER|||||||0.909|TWO_SIDED||||||t-test, 2 sided|||||||0.909
71688313|NCT01301079|142892509|SUPERIORITY_OR_OTHER|||||||0.737|TWO_SIDED||||||t-test, 2 sided|||||||0.737
71688314|NCT01301079|142892510|SUPERIORITY_OR_OTHER||||||<|0.872|TWO_SIDED||||||t-test, 2 sided|||||||<0.872
71688315|NCT01301079|142892511|SUPERIORITY_OR_OTHER|||||||0.598|TWO_SIDED||||||t-test, 2 sided|||||||0.598
71688316|NCT01301079|142892512|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.485|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.485
71688317|NCT01301079|142892513|SUPERIORITY_OR_OTHER|||||||0.744|TWO_SIDED||||||t-test, 2 sided|||||||0.744
71688318|NCT01301079|142892514|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||t-test, 2 sided|||||||0.540
71688319|NCT01301079|142892515|SUPERIORITY_OR_OTHER|||||||0.673|TWO_SIDED||||||t-test, 2 sided|||||||0.673
71688320|NCT01301079|142892516|SUPERIORITY_OR_OTHER|||||||0.586|TWO_SIDED||||||t-test, 2 sided|||||||0.586
71688321|NCT01301079|142892517|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||t-test, 2 sided|||||||0.077
71688322|NCT01301079|142892518|SUPERIORITY_OR_OTHER|||||||0.677|TWO_SIDED||||||t-test, 2 sided|||||||0.677
71688323|NCT01301079|142892519|SUPERIORITY_OR_OTHER|||||||0.545|TWO_SIDED||||||t-test, 2 sided|||||||0.545
71688324|NCT01301079|142892520|SUPERIORITY_OR_OTHER|||||||0.65|TWO_SIDED||||||t-test, 2 sided|||||||0.650
71688325|NCT01301079|142892521|SUPERIORITY_OR_OTHER|||||||0.593|TWO_SIDED||||||t-test, 2 sided|||||||0.593
71688326|NCT01301079|142892522|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
71688327|NCT01301079|142892523|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
71688328|NCT01301079|142892524|SUPERIORITY_OR_OTHER|||||||0.313|TWO_SIDED||||||Chi-squared|||||||0.313
71688329|NCT01301079|142892525|SUPERIORITY_OR_OTHER|||||||0.611|TWO_SIDED||||||Chi-squared|||||||0.611
71688330|NCT01301079|142892526|SUPERIORITY_OR_OTHER|||||||0.312|TWO_SIDED||||||t-test, 2 sided|||||||0.312
71688331|NCT01301079|142892527|SUPERIORITY_OR_OTHER|||||||0.676|TWO_SIDED||||||t-test, 2 sided|||||||0.676
71688332|NCT01301079|142892528|SUPERIORITY_OR_OTHER|||||||0.938|TWO_SIDED||||||t-test, 2 sided|||||||0.938
71688333|NCT01301079|142892529|SUPERIORITY_OR_OTHER|||||||0.385|TWO_SIDED||||||t-test, 2 sided|||||||0.385
71688334|NCT01301079|142892530|SUPERIORITY_OR_OTHER|||||||0.422|TWO_SIDED||||||t-test, 2 sided|||||||0.422
71688335|NCT01301079|142892531|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.500
71688336|NCT01301079|142892532|SUPERIORITY_OR_OTHER|||||||0.435|TWO_SIDED||||||t-test, 2 sided|||||||0.435
71688337|NCT01301079|142892533|SUPERIORITY_OR_OTHER|||||||0.745|TWO_SIDED||||||t-test, 2 sided|||||||0.745
71688338|NCT01301079|142892534|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||t-test, 2 sided|||||||0.557
71688339|NCT02700425|142892535|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
71688340|NCT02700425|142892535|OTHER||||||<|0.001||||||P-value was not adjusted for multiple comparisons. Test was two-tailed, considered statistically significant with a p-value \<0.05, and conducted using SAS version 9.4 (SAS Institute Inc, Cary, NC) and STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon signed rank test||The sample size was estimated based on the primary endpoint of echocardiographic response to test the hypothesis that an absolute 10% greater improvement in LVEF would be observed with His Bundle Pacing compared to Coronary Sinus Pacing, with a significance level of 0.05 and a power of 0.80. Primary outcome was presented at baseline and 6-months as median (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with the Wilcoxon signed rank test.||||<0.001
71688341|NCT02700425|142892536|OTHER|paired t-test||||||0.002||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
71881770|NCT02255409|143282582|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||1.5|1.2|
71881771|NCT02255409|143282582|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.2|1.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||1.6|1.2|
71921253|NCT01234337|143363516|SUPERIORITY_OR_OTHER||LSM Difference|-0.025|||||TWO_SIDED|95.0|-0.053|0.002||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.002|-0.053|
71921254|NCT01234337|143363517|SUPERIORITY_OR_OTHER||LSM Difference|-1.696|||||TWO_SIDED|95.0|-3.619|0.227||||||Estimate of Difference (least squares mean \[LSM\] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.||0.227|-3.619|
71921255|NCT01234337|143363518|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.14|||||TWO_SIDED|90.0|0.92|1.4||||||Statistical analysis for Cmax: 5-fluorouracil||1.40|0.92|
71921256|NCT01234337|143363518|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.29|||||TWO_SIDED|90.0|1.07|1.56||||||Statistical analysis for Cmax: Capecitabine||1.56|1.07|
71921257|NCT01234337|143363519|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.11|||||TWO_SIDED|90.0|0.95|1.3||||||Statistical analysis for AUC(0-tlast): 5-fluorouracil||1.30|0.95|
71921258|NCT01234337|143363519|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.39|||||TWO_SIDED|90.0|1.22|1.58||||||Statistical analysis for AUC(0-tlast): Capecitabine||1.58|1.22|
71921259|NCT01646255|143363549|SUPERIORITY_OR_OTHER||Least Square Mean|-1.2|||=|0.0002|TWO_SIDED|95.0|-1.83|-0.57||Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.|ANCOVA|||"Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent off. The ANCOVA model contained treatment and (pooled) site as factors and Baseline off time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis."||-0.57|-1.83|=0.0002
71921260|NCT02430389|143363579|SUPERIORITY_OR_OTHER|||||||0.0575|TWO_SIDED||||||t-test, 2 sided|||||||.0575
71921261|NCT02430389|143363580|SUPERIORITY_OR_OTHER|||||||0.348|TWO_SIDED||||||t-test, 2 sided|||||||.348
71921262|NCT01468844|143363591|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|15.3|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921263|NCT01468844|143363592|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921264|NCT01468844|143363593|OTHER|The difference between the minocycline and placebo treatment arms in number of participants improving ≥ 1 logOCT scale step in the study eye at Month 24 compared to baseline is reported|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921265|NCT01468844|143363594|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 12 is reported.|Mean Difference (Net)|-5.0|STANDARD_DEVIATION|2.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921266|NCT01468844|143363595|OTHER|The mean difference between the minocycline and placebo treatment arms in number of bevacizumab injections received from baseline to Month 24 is reported.|Mean Difference (Net)|-8.2|STANDARD_DEVIATION|4.4|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921267|NCT01468844|143363596|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 3 compared to baseline is reported.|Mean Difference (Net)|-2.5|STANDARD_DEVIATION|1.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71881772|NCT02255409|143282582|OTHER||GMT Ratio|1.82|||||TWO_SIDED|95.0|1.5|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.2|1.5|
71881773|NCT02255409|143282582|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.5|2.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 22.||2.0|1.5|
71881774|NCT02255409|143282582|OTHER||GMT Ratio|1.85|||||TWO_SIDED|95.0|1.6|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 181.||2.2|1.6|
71881775|NCT02255409|143282582|OTHER||GMT Ratio|3.24|||||TWO_SIDED|95.0|2.7|4.0||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 1.||4.0|2.7|
71881776|NCT02255409|143282582|OTHER||GMT Ratio|1.49|||||TWO_SIDED|95.0|1.2|1.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 22.||1.8|1.2|
71881777|NCT02255409|143282582|OTHER||GMT Ratio|1.29|||||TWO_SIDED|95.0|1.1|1.5||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Victoria at Day 181.||1.5|1.1|
71881778|NCT02255409|143282584|OTHER||Mean Difference (Final Values)|5.7|||||TWO_SIDED|95.0|-5.2|16.3||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||16.3|-5.2|
71881779|NCT02255409|143282584|OTHER||Mean Difference (Final Values)|14.5|||||TWO_SIDED|95.0|5.3|23.6||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||23.6|5.3|
71921268|NCT01468844|143363597|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|-0.8|STANDARD_DEVIATION|3.5|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71881780|NCT02255409|143282585|OTHER||Mean Difference (Final Values)|16.3|||||TWO_SIDED|95.0|9.5|24.1||||||Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181||24.1|9.5|
71881781|NCT02255409|143282585|OTHER||Mean Difference (Final Values)|46.4|||||TWO_SIDED|95.0|35.9|55.8||||||Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181||55.8|35.9|
71881782|NCT02255409|143282586|OTHER||GMT Ratio|2.63|||||TWO_SIDED|95.0|1.8|3.8||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 1.||3.8|1.8|
71881783|NCT02255409|143282586|OTHER||GMT Ratio|1.57|||||TWO_SIDED|95.0|1.3|2.9||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.9|1.3|
71881784|NCT02255409|143282586|OTHER||GMT Ratio|1.7|||||TWO_SIDED|95.0|1.3|2.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||2.2|1.3|
71881785|NCT02255409|143282586|OTHER||GMT Ratio|1.99|||||TWO_SIDED|95.0|1.5|2.6||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for B/Yamagata at Day 1.||2.6|1.5|
71881786|NCT02255409|143282586|OTHER||GMT Ratio|2.21|||||TWO_SIDED|95.0|1.8|2.7||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 22.||2.7|1.8|
71881787|NCT02255409|143282586|OTHER||GMT Ratio|2.55|||||TWO_SIDED|95.0|2.1|3.2||||||GMTr values between aQIV vs. QIV (ie, GMT\[aQIV\]:GMT\[QIV\]) for A/H3N2 at Day 181.||3.2|2.1|
71881788|NCT00345176|143282601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9|||<|0.013|TWO_SIDED|98.7|0.76|1.07||Adjusted for 3 treatment versus placebo comparisons and interim analyses|Regression, Cox|Adjusted for baseline AMD status|The reference group is placebo.|Each of the 3 active arms was compared to the placebo/control arm.||1.07|0.76|<0.013
71881789|NCT00345176|143282601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|||<|0.013|TWO_SIDED|98.7|0.82|1.16||Adjusted for multiple comparisons|Regression, Cox|||||1.16|0.82|<0.013
71881790|NCT00345176|143282601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||<|0.013|TWO_SIDED|98.7|0.75|1.06|||Regression, Cox|Adjusted for multiple comparisons||||1.06|0.75|<0.013
71881791|NCT00345176|143282602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||<|0.05|TWO_SIDED|95.0|0.84|1.08|||Regression, Cox|||||1.08|0.84|<0.05
71881792|NCT00345176|143282602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.09|||Regression, Cox|||||1.09|0.84|<0.05
71881793|NCT00345176|143282602|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94|||<|0.05|TWO_SIDED|95.0|0.83|1.07|||Regression, Cox|||||1.07|0.83|<0.05
71881794|NCT00345176|143282603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04|||<|0.05|TWO_SIDED|95.0|0.77|1.4|||Regression, Cox|||Comparison of Lutein/Zeaxantin versus Control for mortality||1.40|0.77|<0.05
71881795|NCT00345176|143282603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13|||<|0.05|TWO_SIDED|95.0|0.84|1.52|||Regression, Cox|||Comparison of DHA/EPA versus Placebo for mortality||1.52|0.84|<0.05
71881796|NCT00345176|143282603|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23|||<|0.05|TWO_SIDED|95.0|0.92|1.65|||Regression, Cox|||Comparison of Lutein/Zeaxanthin + DHA/EPA versus Placebo for Mortality||1.65|0.92|<0.05
71881797|NCT00345176|143282604|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|||<|0.05|TWO_SIDED|95.0|0.84|1.1|||Regression, Cox|||||1.10|0.84|<0.05
71881798|NCT02370615|143282610|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|2.012|||||TWO_SIDED|90.0|1.632|2.481||||||Analysis for TAK 272F||2.481|1.632|
71881799|NCT02370615|143282610|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.089|||||TWO_SIDED|90.0|0.064|0.123||||||Analysis for TAK 272-M-I||0.123|0.064|
71921269|NCT01468844|143363598|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|-3.0|STANDARD_DEVIATION|3.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71881800|NCT02370615|143282611|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.888|||||TWO_SIDED|90.0|4.137|5.777||||||Analysis for TAK 272F||5.777|4.137|
71881801|NCT02370615|143282612|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|4.702|||||TWO_SIDED|90.0|3.969|5.569||||||Analysis for TAK 272F||5.569|3.969|
71881802|NCT02370615|143282612|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 10/Day 1)|0.023|||||TWO_SIDED|90.0|0.012|0.045||||||Analysis for TAK 272-M-I||0.045|0.012|
71881803|NCT02370615|143282614|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.349|||||TWO_SIDED|90.0|1.117|1.628||||||||1.628|1.117|
71881804|NCT02370615|143282615|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.02|||||TWO_SIDED|90.0|0.919|1.131||||||||1.131|0.919|
71881805|NCT02370615|143282616|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.155|||||TWO_SIDED|90.0|1.035|1.289||||||||1.289|1.035|
71881806|NCT02370615|143282618|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.235|||||TWO_SIDED|90.0|1.1|1.387||||||Analysis for Midazolam||1.387|1.100|
71881807|NCT02370615|143282618|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|0.887|||||TWO_SIDED|90.0|0.781|1.008||||||Analysis for 1'Hydroxymidazolam||1.008|0.781|
71921270|NCT01468844|143363599|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|2.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921271|NCT01468844|143363600|OTHER|The mean difference between the minocycline and placebo groups in the change in macular sensitivity in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|-5.4|STANDARD_DEVIATION|3.8|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921272|NCT01468844|143363601|OTHER|The mean difference between the minocycline and placebo arms in change in BCVA in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|30.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921273|NCT01468844|143363602|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 6 compared to baseline is reported.|Mean Difference (Net)|39.3|STANDARD_DEVIATION|113.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921274|NCT01468844|143363603|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 12 compared to baseline is reported.|Mean Difference (Net)|313.2|STANDARD_DEVIATION|267.3|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921275|NCT01468844|143363604|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 18 compared to baseline is reported.|Mean Difference (Net)|428.5|STANDARD_DEVIATION|146.2|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921276|NCT01468844|143363605|OTHER|The mean difference between the minocycline and placebo treatment arms in change in retinal thickness as measured by OCT in the study eye at Month 24 compared to baseline is reported.|Mean Difference (Net)|119.0|STANDARD_DEVIATION|66.6|||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921277|NCT01468844|143363606|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921278|NCT01468844|143363606|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|-1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921279|NCT01468844|143363606|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 12 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71881808|NCT02370615|143282619|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.422|||||TWO_SIDED|90.0|1.29|1.568||||||Analysis for Midazolam||1.568|1.290|
71881809|NCT02370615|143282619|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.081|||||TWO_SIDED|90.0|1.008|1.16||||||Analysis for 1'Hydroxymidazolam||1.160|1.008|
71881810|NCT02370615|143282620|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.425|||||TWO_SIDED|90.0|1.291|1.574||||||Analysis for Midazolam||1.574|1.291|
71881811|NCT02370615|143282620|SUPERIORITY_OR_OTHER||Geometric Mean Ratio (Day 7/Day 1)|1.061|||||TWO_SIDED|90.0|0.986|1.143||||||Analysis for 1'Hydroxymidazolam||1.143|0.986|
71881812|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|0.114|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.087|0.142|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.142|0.087|<0.0001
71881813|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.078|0.133|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.133|0.078|<0.0001
71921280|NCT01468844|143363607|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing a decrease in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|1.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921281|NCT01468844|143363607|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing an increase in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71881814|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|0.058|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|0.03|0.085|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.085|0.030|0.0001
71881815|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0139||0.5223|TWO_SIDED|95.0|-0.036|0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.018|-0.036|0.5223
71881816|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|-0.057|STANDARD_ERROR_OF_MEAN|0.0139||0.0001|TWO_SIDED|95.0|-0.084|-0.029|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.029|-0.084|0.0001
71881817|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|-0.048|STANDARD_ERROR_OF_MEAN|0.0138||0.0007|TWO_SIDED|95.0|-0.075|-0.02|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.020|-0.075|0.0007
71881818|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|-0.114|STANDARD_ERROR_OF_MEAN|0.0141|<|0.0001|TWO_SIDED|95.0|-0.142|-0.086|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.086|-0.142|<0.0001
71881819|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|-0.056|STANDARD_ERROR_OF_MEAN|0.0141||0.0001|TWO_SIDED|95.0|-0.084|-0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.028|-0.084|0.0001
71881820|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|-0.009|STANDARD_ERROR_OF_MEAN|0.0141||0.5394|TWO_SIDED|95.0|-0.036|0.019|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.019|-0.036|0.5394
71881821|NCT01136655|143282627|SUPERIORITY_OR_OTHER||LS mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.014||0.9863|TWO_SIDED|95.0|-0.027|0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.028|-0.027|0.9863
71881822|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|0.105|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.056|0.155|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.155|0.056|<0.0001
71881823|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|0.066|STANDARD_ERROR_OF_MEAN|0.0252||0.0092|TWO_SIDED|95.0|0.017|0.116|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.116|0.017|0.0092
71881824|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|0.015|STANDARD_ERROR_OF_MEAN|0.0252||0.5509|TWO_SIDED|95.0|-0.035|0.065|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.065|-0.035|0.5509
71881825|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|-0.039|STANDARD_ERROR_OF_MEAN|0.0249||0.1163|TWO_SIDED|95.0|-0.088|0.01|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.010|-0.088|0.1163
71881826|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.025||0.0004|TWO_SIDED|95.0|-0.14|-0.041|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.041|-0.140|0.0004
71881827|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|-0.051|STANDARD_ERROR_OF_MEAN|0.0247||0.04|TWO_SIDED|95.0|-0.1|-0.002|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.002|-0.100|0.0400
71881828|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|-0.083|STANDARD_ERROR_OF_MEAN|0.0252||0.0011|TWO_SIDED|95.0|-0.133|-0.034|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.034|-0.133|0.0011
71881829|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|-0.068|STANDARD_ERROR_OF_MEAN|0.0254||0.0077|TWO_SIDED|95.0|-0.118|-0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.018|-0.118|0.0077
71881830|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|-0.017|STANDARD_ERROR_OF_MEAN|0.0252||0.4957|TWO_SIDED|95.0|-0.067|0.033|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.033|-0.067|0.4957
71881831|NCT01136655|143282628|SUPERIORITY_OR_OTHER||LS mean difference|0.022|STANDARD_ERROR_OF_MEAN|0.025||0.38|TWO_SIDED|95.0|-0.027|0.071|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.071|-0.027|0.3800
71881832|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|0.107|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.073|0.14|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.140|0.073|<0.0001
71688342|NCT02700425|142892536|OTHER|paired t-test||||||0.002|||||||t-test, 2 sided|||Primary outcome of His Bundle Pacing was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.002
71688343|NCT02700425|142892537|OTHER|Log rank test of a survival analysis||||||0.62||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular hospitalization or death by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.62
71688344|NCT02700425|142892538|OTHER|||||||0.09||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of Coronary Sinus Pacing arm was presented at baseline as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with a Wilcoxon sign rank test.||||0.09
71688345|NCT02700425|142892538|OTHER|||||||0.32||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|Wilcoxon sign rank test||NYHA functional class of the His Bundle Pacing arm was presented at baseline and 12 months as medians (interquartile ranges) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon sign rank test.||||0.32
71688346|NCT02700425|142892539|OTHER|||||||0.35||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with His Bundle Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.35
71688347|NCT02700425|142892539|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Quality of Life was presented at baseline and 1-year as medians (interquartile range) for patients with Coronary Sinus Pacing based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.07
71688348|NCT02700425|142892540|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first cardiovascular rehospitalization by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
71688349|NCT02700425|142892541|OTHER|Log rank test of a survival analysis||||||0.14||||||P-value did not need to be adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Log Rank|||Primary outcome of time to first treated VT/VF by His Bundle Pacing compared to Coronary Sinus Pacing presented median and interquartile range in years based upon the Shapiro-Wilks test of normality, and then analyzed with a log rank test.||||0.14
71688350|NCT00571103|142892552|SUPERIORITY_OR_OTHER||Mean Slope|-0.985|STANDARD_ERROR_OF_MEAN|0.158||0.05|TWO_SIDED|95.0|-1.0|1.0|||Linear mixed effects|||||1|-1|0.05
71881833|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|0.112|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|0.078|0.146|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.146|0.078|<0.0001
71881834|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|0.057|STANDARD_ERROR_OF_MEAN|0.0172||0.0011|TWO_SIDED|95.0|0.023|0.09|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.090|0.023|0.0011
71881835|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|0.005|STANDARD_ERROR_OF_MEAN|0.0169||0.7589|TWO_SIDED|95.0|-0.028|0.039|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.039|-0.028|0.7589
71921282|NCT01468844|143363607|OTHER|The difference between the minocycline and treatment arms in the number of participants experiencing no change in fluid leakage at Month 24 compared to baseline is reported.|Difference in Number of Participants|0.0|||||TWO_SIDED||||||||Difference = Minocycline - Placebo|||||
71921283|NCT02380703|143363623|SUPERIORITY||Hazard Ratio (HR)|1.34||||0.29|TWO_SIDED|95.0|0.78|2.32||For participants who dropped out, their time until study attrition was used as the exposure period; and they were carried forward as part of the overall incidence count.|Regression, Cox|||Sample-size calculations were performed, based on the ability to detect a small-to-moderate difference (Cohen's h = 0.4) in rate of aggression onset over a 1-year period between APT and EU-PC, assuming 80% power and a type I error rate of 5%. Given an anticipated rate of aggression onset over 1 year of 37% for EU-PC, an ES of h = 0.4 allows detection of aggression onset in APT as high as 19%. Given this effect size and up to 10% attrition, our goal was to include 220 total participants.||2.32|0.78|0.29
71881836|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|-0.05|STANDARD_ERROR_OF_MEAN|0.017||0.0035|TWO_SIDED|95.0|-0.084|-0.017|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.017|-0.084|0.0035
71881837|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|-0.055|STANDARD_ERROR_OF_MEAN|0.0168||0.0011|TWO_SIDED|95.0|-0.089|-0.022|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.022|-0.089|0.0011
71881838|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|-0.115|STANDARD_ERROR_OF_MEAN|0.0171|<|0.0001|TWO_SIDED|95.0|-0.149|-0.081|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.081|-0.149|<0.0001
71881839|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|-0.058|STANDARD_ERROR_OF_MEAN|0.0172||0.0008|TWO_SIDED|95.0|-0.092|-0.024|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||-0.024|-0.092|0.0008
71881840|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|-0.003|STANDARD_ERROR_OF_MEAN|0.0172||0.8582|TWO_SIDED|95.0|-0.037|0.031|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.031|-0.037|0.8582
71881841|NCT01136655|143282629|SUPERIORITY_OR_OTHER||LS mean difference|-0.008|STANDARD_ERROR_OF_MEAN|0.017||0.6276|TWO_SIDED|95.0|-0.042|0.025|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.||0.025|-0.042|0.6276
71881842|NCT01136655|143282630|SUPERIORITY_OR_OTHER||LS mean difference|0.52|||<|0.0001|TWO_SIDED|95.0|0.393|0.7|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.700|0.393|<0.0001
71881843|NCT01136655|143282630|SUPERIORITY_OR_OTHER||LS mean difference|0.26|||<|0.0001|TWO_SIDED|95.0|0.194|0.347|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.347|0.194|<0.0001
71881844|NCT01136655|143282630|SUPERIORITY_OR_OTHER||LS mean difference|0.29|||<|0.0001|TWO_SIDED|95.0|0.214|0.396|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.396|0.214|<0.0001
71881845|NCT01136655|143282630|SUPERIORITY_OR_OTHER||LS mean difference|0.49|||<|0.0001|TWO_SIDED|95.0|0.371|0.659|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.659|0.371|<0.0001
71881846|NCT01136655|143282630|SUPERIORITY_OR_OTHER||LS mean difference|0.56||||0.0002|TWO_SIDED|95.0|0.409|0.755|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||0.755|0.409|0.0002
71881847|NCT01136655|143282630|SUPERIORITY_OR_OTHER||LS mean difference|1.12||||0.4512|TWO_SIDED|95.0|0.827|1.528|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) \[log(response + 1) if response is 0\].||Factors in the ANOVA model included: patient, period and treatment.||1.528|0.827|0.4512
71881848|NCT01970501|143282653|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.905|TWO_SIDED|95.0|0.72|1.45|||Log Rank|||||1.45|.72|0.905
71881849|NCT01970501|143282654|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.961|TWO_SIDED|95.0|0.71|1.42|||Log Rank|||||1.42|0.71|0.961
71881850|NCT03924752|143282657|OTHER|A two-way repeated-measures analysis of variance (ANOVA) was performed on different walking conditions (including the baseline of not wearing the exoskeleton) on the subject's overground self-selected walking speed across different locomotion modes by setting the significant value to 0.05. Two independent variables were assistance type (Exo vs No Exo) and different locomotion modes.||||||0.9547||||||This presents the effect of exoskeleton assistance on the user's preferred overground walking speed across different locomotion modes.|ANOVA|||||||0.9547
71881851|NCT03803059|143282658|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean change from baseline is zero||||<0.01
71881852|NCT03803059|143282659|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4 (no change).||||<0.01
71881853|NCT03803059|143282660|SUPERIORITY||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Calculated using the Wilcoxon signed rank test. Testing hypothesis is that the mean score is equal to 4.||||<0.01
71881854|NCT03803059|143282661|SUPERIORITY|||||||0.051|||||||t-test, 1 sided|||Calculated using paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.051
71881855|NCT03803059|143282662|SUPERIORITY||||||<|0.01|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||<0.01
71881856|NCT03803059|143282663|SUPERIORITY|||||||0.331|||||||t-test, 1 sided|||Calculated from paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.331
71881857|NCT03803059|143282664|SUPERIORITY|||||||0.863|||||||t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.863
71881858|NCT03803059|143282665|SUPERIORITY|||||||0.048|||||||t-test, 2 sided|||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.048
71881859|NCT03803059|143282666|SUPERIORITY|||||||0.355||||||P-value reported is for viscoelastic deformation.|t-test, 2 sided|at significance level alpha+0.05||Calculated using the paired t-test. The testing hypothesis is that the mean change from baseline is zero.||||0.355
71881860|NCT03803059|143282667|SUPERIORITY|||||||0.859||||||Calculated with a paired T test. Testing hypothesis is that the mean change from baseline is zero.|t-test, 2 sided|||Calculated using the paired t test. Testing hypothesis is that the mean change from baseline is zero.||||0.859
71881861|NCT03803059|143282668|EQUIVALENCE|.A binomial (sign) test was performed to test if the the proportion of the combined designated favorable evaluations/responses is equal to the combined designated negative evaluations/responses for each question|||||<|0.01|||||||Sign test|||Patient satisfaction questionnaires were tabulated, and the frequency and percentage of all response options were reported for each question and time point calculated from the binomial (sign) test. The testing hypothesis is that the proportion of favorable responses is equal to the unfavorable||||<0.01
71881862|NCT03803059|143282669|SUPERIORITY|||||||0.031||||||All statistical tests were 2-sided at significance level alpha=0.05. No multiple testing corrections were considered in the study.|t-test, 2 sided|||The null hypothesis that the mean change from baseline is zero was tested using a paired t-test||||0.031
71881863|NCT02116777|143282670|OTHER|Maximum Tolerate Dose Level was determined by the rolling-6 design.|Maximum Tolerate Dose Level|4.0|||||TWO_SIDED||||||||Maximum Tolerate Dose Level is Dose Level 4 (600 mcg/m²/dose +30 mg/m2/dose (BMN 673) BID + 30 mg/m²/dose (TEM), Max 1000 mcg/day). MTD determined by using the Rolling-6 Design.|||||
71881864|NCT00102960|143282689|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59||||0.02|TWO_SIDED|95.0|0.38|0.93|||Regression, Cox|||Statistical analysis compares early therapy 40 weeks (ART-40W) relative to deferred therapy (ART-Def)||0.93|0.38|0.02
71881865|NCT00102960|143282689|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.47||||0.002|TWO_SIDED|95.0|0.27|0.76|||Regression, Cox|||Statistical analysis compares early therapy 96 weeks (ART-96W) relative to deferred therapy (ART-Def)||0.76|0.27|0.002
71688351|NCT03959527|142892586|NON_INFERIORITY|A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority \[NI\] margin for the primary endpoint).|Risk Difference (RD)|5.31|||||TWO_SIDED|95.0|1.38|8.65|||||95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin|Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.||8.65|1.38|
71688352|NCT02020889|142892631|OTHER||Odds Ratio (OR)|5.91|||<|0.001|TWO_SIDED|95.0|2.68|13.03|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||13.03|2.68|<0.001
71688353|NCT02020889|142892632|OTHER||Odds Ratio (OR)|16.74|||<|0.001|TWO_SIDED|95.0|3.61|77.56|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||77.56|3.61|<0.001
71688354|NCT02020889|142892633|OTHER||Hazard Ratio (HR)|0.322|||<|0.001|TWO_SIDED|95.0|0.206|0.502|||Cox Proportional Hazard regression|Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||0.502|0.206|<0.001
71688355|NCT02020889|142892634|OTHER||Odds Ratio (OR)|0.2|||<|0.001|TWO_SIDED|95.0|0.09|0.41|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||0.41|0.09|<0.001
71688356|NCT02020889|142892635|OTHER||Odds Ratio (OR)|19.65||||0.007|TWO_SIDED|95.0|2.3|167.93|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||167.93|2.30|0.007
71688357|NCT02020889|142892636|OTHER||Odds Ratio (OR)|5.31|||<|0.001|TWO_SIDED|95.0|2.63|10.74|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo|||10.74|2.63|<0.001
71881866|NCT00102960|143282694|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Cummulative Probability|0.13||||0.03|TWO_SIDED|95.0|0.01|0.25|||Proportion test|||Relative to ART-Def, ART-40W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.25|0.01|0.03
71688358|NCT02020889|142892637|OTHER||Odds Ratio (OR)|7.19|||<|0.001|TWO_SIDED|95.0|2.6|19.87|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo|||19.87|2.60|<0.001
71921284|NCT02380703|143363623|EQUIVALENCE|Examination of whether the presence of aggression is equivalent between APT and EU-PC|Difference in frequencies|1.21||||0.27|TWO_SIDED|||||Association between presence of aggression and condition (APT vs EU-PC).|Chi-squared|X2(1) = 1.21||||||0.27
71881867|NCT00102960|143282694|SUPERIORITY||Kaplan-Meier Cummulative Probability|0.2||||0.0006|TWO_SIDED|95.0|0.09|0.31|||Proportion test|||Relative to ART-Def, ART-96W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years||0.31|0.09|0.0006
71921285|NCT02380703|143363624|SUPERIORITY||F-statistic|1.59||||0.19|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.19
71921286|NCT02380703|143363625|SUPERIORITY||F-statistic|2.43||||0.06|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.06
71921287|NCT02380703|143363626|SUPERIORITY||F-statistic|0.33||||0.8|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.80
71881868|NCT00102960|143282695|SUPERIORITY_OR_OTHER_LEGACY||Rate per 100 person years|0.0|||<|0.0001|TWO_SIDED|||||This p-value compares event rates per 100 person-years across the three arms|Poisson Regression|||The CHER study compared Grade 3 or 4 clinical event rates per 100 person-years between the three arms using Poisson regression modeling over the study duration of 4.8 years.|The rates per 100 person-years were 33.8 (Arm 1), 21.6 (Arm 2) and 16 (Arm 3)|||<0.0001
71881869|NCT00102960|143282696|SUPERIORITY||Rate per 100 person years|0.0||||0.46|TWO_SIDED||||||Poisson regression|||The event rates per 100 person years were compared across the three arms|The laboratory events per 100 person years across the three arms were: 7 (Deferred arm), 8.1 (early therapy for 40 weeks) and 6 (early therapy for 96 weeks).|||0.46
71881870|NCT00102960|143282699|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.48||||0.011|TWO_SIDED|95.0|0.27|0.84|||Regression, Cox||Hazard rate reported above compares early therapy 40 weeks relative to the deferred therapy arm.|The analysis compares ART-40W relative to the ART-Def arm.||0.84|0.27|0.011
71881871|NCT00102960|143282699|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.34||||0.0009|TWO_SIDED|95.0|0.18|0.64|||Regression, Cox||The hazard ratio compares ART-96W relative to the ART-Def arm.|The analysis compares ART-96 Weeks relative to ART-Deferred||0.64|0.18|0.0009
71881872|NCT00102960|143282701|SUPERIORITY||Count of days|0.0||||0.004|TWO_SIDED|||||The p-value here compares the days spent in hospital across the three arms|Poisson regression||||The total number of days/count of days: 1018 (Arm 1), 533 (Arm 2) and 414 (Arm 3) were compared across the three groups by Poisson regression analysis.|||0.004
71881873|NCT00102960|143282702|SUPERIORITY||Hazard Ratio (HR)|0.562||||0.0021|TWO_SIDED|95.0|0.389|0.811|||Regression, Cox|||||0.811|0.389|0.0021
71881874|NCT00102960|143282702|SUPERIORITY||Hazard Ratio (HR)|0.583||||0.0038|TWO_SIDED|95.0|0.405|0.84|||Regression, Cox|||||0.840|0.405|0.0038
71881875|NCT00980200|143282705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|||<|0.001|TWO_SIDED|95.0|0.049|0.14|||ANCOVA|||||0.140|0.049|<0.001
71881876|NCT00980200|143282705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.095|0.185|||ANCOVA|||||0.185|0.095|<0.001
71881877|NCT00980200|143282705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.057|0.147|||ANCOVA|||||0.147|0.057|<0.001
71881878|NCT00980200|143282705|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|||<|0.001|TWO_SIDED|95.0|0.08|0.17|||ANCOVA|||||0.170|0.080|<0.001
71922495|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.2||||0.269|TWO_SIDED|95.0|-1.8|6.1|||Cochran-Mantel-Haenszel|||Week 6:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||6.1|-1.8|0.269
71881879|NCT00457015|143282707|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The primary efficacy analysis compared the change from baseline in MSCS Score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.010
71881880|NCT00457015|143282708|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.||||0.003
71881881|NCT00457015|143282709|SUPERIORITY_OR_OTHER_LEGACY|||||||0.102||95.0||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||Kaplan-Meier analysis using the Log-Rank test was used to compare the time distribution between the 2 treatment groups.||||0.102
71881882|NCT02257372|143282715|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.123|||<|0.001|TWO_SIDED|95.0|0.071|0.174|||Mixed model repeated measures analysis|||||0.174|0.071|<0.001
71881883|NCT02257372|143282716|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|||<|0.001|TWO_SIDED|95.0|0.099|0.197|||Mixed model repeated measures analysis|||||0.197|0.099|<0.001
71881884|NCT02104583|143282724|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.52||||0.152|TWO_SIDED|95.0|0.86|2.71|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or rest of world (ROW)\].||2.71|0.86|0.152
71881885|NCT02104583|143282724|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|0.82||||0.662|TWO_SIDED|95.0|0.34|1.97|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW\].||1.97|0.34|0.662
71881886|NCT02104583|143282724|SUPERIORITY||Eleclazine : Placebo Incident Rate Ratio|1.24||||0.618|TWO_SIDED|95.0|0.54|2.86|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region \[US or ROW.||2.86|0.54|0.618
71881887|NCT03045861|143282762|OTHER||Emax|-1.822|||||TWO_SIDED|95.0|-2.333|1.31||||||||1.310|-2.333|
71881888|NCT03045861|143282762|OTHER||ED50|1020.755|||||TWO_SIDED|95.0|100.786|1940.724||||||||1940.724|100.786|
71922496|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.723|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.723
71881889|NCT03045861|143282762|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.095|0.306||||||||0.306|0.095|
71881890|NCT03045861|143282763|OTHER||Emax|-1.801|||||TWO_SIDED|95.0|-2.319|-1.283||||||||-1.283|-2.319|
71881891|NCT03045861|143282763|OTHER||ED50|55.572|||||TWO_SIDED|95.0|3.565|107.579||||||||107.579|3.565|
71881892|NCT03045861|143282763|OTHER||s2e|0.206|||||TWO_SIDED|95.0|0.097|0.314||||||||0.314|0.097|
71881893|NCT03045861|143282764|OTHER||Emax|-1.846|||||TWO_SIDED|95.0|-2.352|-1.34||||||||-1.340|-2.352|
71881894|NCT03045861|143282764|OTHER||ED50|32.415|||||TWO_SIDED|95.0|4.687|60.143||||||||60.143|4.687|
71881895|NCT03045861|143282764|OTHER||s2e|0.2|||||TWO_SIDED|95.0|0.094|0.305||||||||0.305|0.094|
71881896|NCT00940589|143282838|SUPERIORITY_OR_OTHER||||||<|0.045|TWO_SIDED||||||ANCOVA|||||||<0.045
71881897|NCT00940589|143282839|SUPERIORITY_OR_OTHER||||||<|0.044|TWO_SIDED||||||ANCOVA|||||||<0.044
71881898|NCT01918007|143282840|SUPERIORITY||Odds Ratio (OR)|1.3||||0.54|TWO_SIDED|95.0|0.5|3.3|||Chi-squared|||||3.3|0.5|0.54
71881899|NCT01918007|143282841|SUPERIORITY||Odds Ratio (OR)|14.0|||<|0.001|TWO_SIDED|95.0|2.9|68.4|||Chi-squared|||||68.4|2.9|<0.001
71881900|NCT01918007|143282842|SUPERIORITY||Mean Difference (Net)|-0.31|||<|0.001|TWO_SIDED|95.0|-0.35|-0.27|||t-test, 2 sided|||||-0.27|-0.35|<0.001
71881901|NCT01918007|143282843|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71881902|NCT01918007|143282844|SUPERIORITY||Mean Difference (Net)|-2.76|||<|0.001|TWO_SIDED|95.0|-3.63|-1.9|||t-test, 2 sided|||||-1.90|-3.63|<0.001
71881903|NCT01918007|143282845|SUPERIORITY||Risk Ratio (RR)|1.16||||0.553|TWO_SIDED|95.0|0.71|1.89|||Chi-squared|||||1.89|0.71|0.553
71881904|NCT01918007|143282846|SUPERIORITY||Risk Ratio (RR)|1.79||||0.057|TWO_SIDED|95.0|0.98|3.27|||Chi-squared|||||3.27|0.98|0.057
71881905|NCT01918007|143282847|SUPERIORITY||Risk Ratio (RR)|2.29||||0.084|TWO_SIDED|95.0|0.84|6.25|||Chi-squared|||||6.25|0.84|0.084
71881906|NCT01918007|143282848|SUPERIORITY|||||||0.547|||||||Wilcoxon (Mann-Whitney)|||||||0.547
71881907|NCT01918007|143282849|SUPERIORITY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||||||0.062
71881908|NCT01918007|143282850|SUPERIORITY|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
71881909|NCT01918007|143282851|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
71881910|NCT01918007|143282852|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||||||0.074
71881911|NCT00960661|143282861|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.|Mean Difference (Final Values)|-0.04||||0.6273|TWO_SIDED|95.0|-0.18|0.11||The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Mixed model repeated measures|||The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.||0.11|-0.18|0.6273
71881912|NCT00530270|143282885|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.127
71881913|NCT00530270|143282886|SUPERIORITY_OR_OTHER|||||||0.801||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.801
71881914|NCT00530270|143282887|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.02
71881915|NCT00530270|143282888|SUPERIORITY_OR_OTHER|||||||0.876||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.876
71881916|NCT00530270|143282889|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.||||0.770
71881917|NCT02324920|143282891|SUPERIORITY||Hazard Ratio (HR)|0.22|||<|0.001|TWO_SIDED|95.0|0.11|0.46|||Regression, Cox||||Additional models were implemented to control for country and investigational sites effect on primary endpoint.|0.46|0.11|<0.001
71881918|NCT02324920|143282892|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.002|TWO_SIDED|95.0|0.27|0.75|||Regression, Cox|||||0.75|0.27|0.002
71881919|NCT01399788|143282899|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.81|||||TWO_SIDED|90.0|99.2|108.64||||||Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||108.64|99.20|
71881920|NCT01399788|143282899|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|107.28|||||TWO_SIDED|90.0|101.95|112.9||||||Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||112.90|101.95|
71881921|NCT01399788|143282899|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
71881922|NCT01399788|143282900|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|102.75|||||TWO_SIDED|90.0|95.36|110.71||||||Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||110.71|95.36|
71881923|NCT01399788|143282900|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|103.85|||||TWO_SIDED|90.0|92.13|117.07||||||Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||117.07|92.13|
71881924|NCT01399788|143282900|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|99.48|||||TWO_SIDED|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.25|94.92|
71881925|NCT01399788|143282901|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.73|||||TWO_SIDED|90.0|99.12|104.4||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.40|99.12|
71881926|NCT01399788|143282902|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|95.17|||||TWO_SIDED|90.0|88.6|102.22||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||102.22|88.60|
71881927|NCT01399788|143282903|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|104.3|||||TWO_SIDED|90.0|99.7|109.1||||||Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||109.10|99.70|
71881928|NCT01399788|143282903|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|105.74|||||TWO_SIDED|90.0|100.32|111.46||||||Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||111.46|100.32|
71881929|NCT01399788|143282903|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|100.97|||||TWO_SIDED|90.0|96.28|105.88||||||Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||105.88|96.28|
71881930|NCT01399788|143282904|SUPERIORITY_OR_OTHER||Ratio of Adjusted Means|101.8|||||TWO_SIDED|90.0|99.24|104.43||||||Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||104.43|99.24|
71881931|NCT02919436|143282908|SUPERIORITY|We found observed rate of postoperative urinary retention in male spine surgery patients to historically be 17%. We hypothesize that the use of tamsulosin can reduce this rate by 50%. A two group continuity corrected chi-square test with a .05 two-sided significance level will have 80% power to detect the difference between a control group proportion of .17 and a treatment group proportion of .085 (odds ratio of .454) when the sample size in each group is 264 and a total sample size of 528.||||||0.96|||||||Chi-squared, Corrected|||||||.96
71881932|NCT03699007|143282911|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71881933|NCT03699007|143282912|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71881934|NCT03259074|143282918|SUPERIORITY||Marginal difference|1.51||||0.7164|TWO_SIDED|95.0|-6.63|9.64||Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.|Regression, Logistic|||||9.64|-6.63|0.7164
71881935|NCT03259074|143282918|SUPERIORITY||Marginal difference|1.67||||0.6925|TWO_SIDED|95.0|-6.61|9.95|||Regression, Logistic|Logistic regression model with treatment as a factor and baseline mSASSS score as a covariate using marginal standardization method.||||9.95|-6.61|0.6925
71881936|NCT03259074|143282919|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.18|||||TWO_SIDED|95.0|-0.646|0.293|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.293|-0.646|
71881937|NCT03259074|143282919|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS mean difference|-0.16|||||TWO_SIDED|95.0|-0.639|0.315|||||ANCOVA model with treatment as a factor and baseline mSASSS score as a covariate.|||0.315|-0.639|
71881938|NCT03259074|143282920|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|4.32|||||TWO_SIDED|95.0|-5.62|14.27|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||14.27|-5.62|
71881939|NCT03259074|143282920|SUPERIORITY|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.09|||||TWO_SIDED|95.0|-9.13|11.31|||||Logistic regression model with treatment as a factor and baseline count of vertebral corners with syndesmophyte as a covariate using marginal standardization method.|||11.31|-9.13|
71881940|NCT03259074|143282921|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.183|STANDARD_ERROR_OF_MEAN|0.1517|||TWO_SIDED|95.0|-0.12|0.48|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||0.48|-0.12|
71881941|NCT03259074|143282921|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.332|STANDARD_ERROR_OF_MEAN|0.1545|||TWO_SIDED|95.0|0.03|0.64|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||0.64|0.03|
71881942|NCT03259074|143282922|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|LS Means|0.877|STANDARD_ERROR_OF_MEAN|0.3316|||TWO_SIDED|95.0|0.22|1.53|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 150 mg||1.53|0.22|
71881943|NCT03259074|143282922|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|LS Means|0.419|STANDARD_ERROR_OF_MEAN|0.3357|||TWO_SIDED|95.0|-0.24|1.08|||||LS Means and 95% CI are from an ANCOVA model with treatment as a factor, baseline Berlin SI joint edema score as a covariate.|Week 104 - 300 mg||1.08|-0.24|
71881944|NCT03259074|143282923|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|1.54|||||TWO_SIDED|95.0|-5.1|8.18|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||8.18|-5.10|
71921288|NCT02380703|143363627|SUPERIORITY||F-statistic|0.21||||0.89|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.89
71921289|NCT02380703|143363628|SUPERIORITY||F-statistic|1.48||||0.22|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.22
71881945|NCT03259074|143282924|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|Marginal difference|-2.34|||||TWO_SIDED|95.0|-10.18|5.51|||||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method.|||5.51|-10.18|
71881946|NCT03259074|143282925|OTHER|Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented|Marginal difference|2.18|||||TWO_SIDED|95.0|-5.34|9.69|||Marginal difference||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||9.69|-5.34|
71881947|NCT03259074|143282926|OTHER||Marginal difference|0.33|||||TWO_SIDED|95.0|-7.08|7.74||Due to to the pre-defined hierarchical testing strategy, p values beyond the primary endpoint which was not met were not presented.|||Estimated mean, marginal difference and 95% confidence interval are from a logistic regression model with treatment as a factor using marginal standardization method|||7.74|-7.08|
71881948|NCT02409290|143282941|SUPERIORITY||Cox Proportional Hazard|0.2||||0.0016|TWO_SIDED|95.0|0.07|0.61|||Log Rank|||||0.61|0.07|0.0016
71881949|NCT02409290|143282942|SUPERIORITY||Cox Proportional Hazard|0.11||||0.0005|TWO_SIDED|95.0|0.03|0.5|||Log Rank|||Control regimen (arm B) uses concurrent controls only||0.50|0.03|0.0005
71881950|NCT00708500|143282943|SUPERIORITY_OR_OTHER||Treatment Difference|37.4|||<|0.0001||95.0|25.7|49.1|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||49.1|25.7|<0.0001
71881951|NCT00708500|143282943|SUPERIORITY_OR_OTHER||Treatment Difference|45.2|||<|0.0001||95.0|33.7|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.7|<0.0001
71881952|NCT00708500|143282944|SUPERIORITY_OR_OTHER||Treatment Difference|39.1|||<|0.0001||95.0|27.2|51.0|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||51.0|27.2|<0.0001
71881953|NCT00708500|143282944|SUPERIORITY_OR_OTHER||Treatment Difference|45.1|||<|0.0001||95.0|33.4|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.|||56.8|33.4|<0.0001
71881954|NCT00595556|143282951|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Mixed Models Analysis|||||||.012
71881955|NCT00595556|143282952|SUPERIORITY_OR_OTHER|||||||0.94||95.0|||||Mixed Models Analysis|||||||.94
71881956|NCT00595556|143282953|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Mixed Models Analysis|||||||.004
71881957|NCT00595556|143282954|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Mixed Models Analysis|||||||.006
71688359|NCT02020889|142892638|OTHER||Odds Ratio (OR)|11.39||||0.003|TWO_SIDED|95.0|2.35|55.24|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.|Mepolizumab 300mg/Placebo|||55.24|2.35|0.003
71688360|NCT03224624|142892658|EQUIVALENCE|Comparing baseline-\>12month SBP change (mean difference) between the two groups.|Mean Difference (Net)|-1.35|STANDARD_ERROR_OF_MEAN|3.8||0.72|TWO_SIDED|||||p\<0.05 considered significant.|t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in SBP|t- tests were done to compare group mean differences between self-management and usual care and within groups Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.72
71688361|NCT03224624|142892658|EQUIVALENCE|Comparing baseline-\>12month DBP change (mean difference) between the two groups.|Mean Difference (Net)|-3.75|STANDARD_ERROR_OF_MEAN|2.55||0.15|TWO_SIDED||||||t-test, 2 sided||direction of comparison: (self-management change over 12 months) - (usual care change over 12 months) in DBP|Mean differences were calculated by subtracting 12-month blood pressure from baseline blood pressure for each participant. t-tests were done to compare mean differences between the two groups.||||0.15
71688362|NCT03224624|142892658|EQUIVALENCE|Comparing baseline-\>12month SBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-6.95||||0.01|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for self-management group (as given in table)|change in SBP from baseline to 12-months within self-management group.||||0.01
71688363|NCT03224624|142892658|EQUIVALENCE|Comparing baseline-\>12month SBP change within usual care group (null hypothesis no change).|Mean Difference (Net)|-5.59|||<|0.05|TWO_SIDED||||||t-test, 2 sided||(12-month SBP)-(baseline SBP) for usual care group (as given in table)|Comparing baseline-\>12month SBP change within usual care group.||||<0.05
71688364|NCT03224624|142892658|EQUIVALENCE|Comparing baseline-\>12month DBP change within self-management group (null hypothesis no change).|Mean Difference (Net)|-5.51|||<|0.01|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for self-management group (as given in table)|change in DBP from baseline to 12-months within self-management group.||||<0.01
71688365|NCT03224624|142892658|EQUIVALENCE|change in DBP from baseline to 12-months within usual care group.|Mean Difference (Net)|-1.76||||0.34|TWO_SIDED||||||t-test, 2 sided||(12-month DBP)-(baseline DBP) for usual care group (as given in table)|||||0.34
71688366|NCT01884545|142892661|SUPERIORITY|||||||0.1073|||||||Regression, Linear|||||||0.1073
71881958|NCT00595556|143282955|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||Mixed Models Analysis|||||||.3
71881959|NCT01765920|143282960|SUPERIORITY|||||||0.0174||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0174
71881960|NCT01765920|143282961|SUPERIORITY|||||||0.0719||||||A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.0719
71881961|NCT01765920|143282962|SUPERIORITY|||||||0.02||||||Total score analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses).|Kruskal-Wallis|||||||0.02
71921290|NCT02380703|143363629|SUPERIORITY||F-statistic|0.38||||0.77|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.77
71688367|NCT01884545|142892661|SUPERIORITY|||||||0.0615|||||||Regression, Linear|||||||0.0615
71688368|NCT01884545|142892662|SUPERIORITY|||||||0.6732|||||||Regression, Linear|||||||0.6732
71688369|NCT01884545|142892662|SUPERIORITY|||||||0.3754|||||||Regression, Linear|||||||0.3754
71688370|NCT01884545|142892663|SUPERIORITY||Odds Ratio (OR)|2.853||||0.0073|TWO_SIDED|95.0|1.326|6.139|||Regression, Logistic|||||6.139|1.326|0.0073
71688371|NCT01884545|142892663|SUPERIORITY||Odds Ratio (OR)|1.045||||0.9068|TWO_SIDED|95.0|0.5|2.183|||Regression, Logistic|||||2.183|0.5|0.9068
71688372|NCT01884545|142892664|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
71881962|NCT01765920|143282962|SUPERIORITY|||||||0.0099||||||"Symptoms domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.0099
71881963|NCT01765920|143282962|SUPERIORITY|||||||0.037||||||"Ability domain analysis. A priori threshold for statistical significance α=0.0221 (Pocock boundary for 3 interim analyses)."|Kruskal-Wallis|||||||0.037
71881964|NCT01765920|143282963|SUPERIORITY|||||||0.22||||||Day 1 analysis.|Fisher Exact|||||||0.22
71881965|NCT01765920|143282963|SUPERIORITY|||||||0.32||||||Day 2 analysis.|Fisher Exact|||||||0.32
71881966|NCT01765920|143282963|SUPERIORITY|||||||0.47||||||Day 3 analysis.|Fisher Exact|||||||0.47
71881967|NCT01765920|143282963|SUPERIORITY|||||||0.72||||||Day 4 analysis.|Fisher Exact|||||||0.72
71881968|NCT01765920|143282963|SUPERIORITY|||||||0.25||||||Day 5 analysis.|Fisher Exact|||||||0.25
71881969|NCT01765920|143282964|SUPERIORITY|||||||0.68|||||||Fisher Exact|||||||0.68
71881970|NCT01923129|143282976|NON_INFERIORITY|The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe \& Altman.|||||<|0.05|TWO_SIDED|95.0|||||Chi-squared|||||||<0.05
71881971|NCT03631732|143282980|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the upper bound of the 2-sided 95% confidence interval (CI) of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL is less than 6% (i.e., a margin of 6% is applied to non-inferiority assessment).|Difference in percentages|-1.2|||||TWO_SIDED|95.0|-4.8|0.9|||||Differences in percentages of participants with HIV-1 RNA \>= 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||0.9|-4.8|
71881972|NCT03631732|143282980|SUPERIORITY|||||||0.3399|||||||Fisher Exact|||||||0.3399
71688373|NCT01884545|142892664|SUPERIORITY||Odds Ratio (OR)|1.333||||0.7822|TWO_SIDED|95.0|0.173|10.254|||Regression, Logistic|||||10.254|0.173|0.7822
71881973|NCT03631732|143282982|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.8|||||TWO_SIDED|95.0|-2.0|6.8|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||6.8|-2.0|
71921291|NCT02380703|143363630|SUPERIORITY||F-statistic|0.56||||0.64|TWO_SIDED|||||P value for interaction between treatment arm and time|Mixed Models Analysis||"Interaction between time and treatment arm:~Numerator df = 3, denominator df = 510"|"Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type.~The main interest was the interaction between group (APT vs EU-PC) and time."||||0.64
71921292|NCT02417935|143363648|NON_INFERIORITY|If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.|Mean Difference (Final Values)|0.072||||0.7|TWO_SIDED|95.0|-0.295|0.439|||Mixed Models Analysis|||||0.439|-0.295|0.700
71921293|NCT02417935|143363649|OTHER||Mean Difference (Final Values)|-0.2||||0.149|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||||0.1|-0.4|0.149
71921294|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|0.1||||0.535|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||Worst Pain||0.6|-0.3|.535
71688374|NCT01884545|142892665|SUPERIORITY|||||||0.7985|||||||Regression, Linear|||||||0.7985
71688375|NCT01884545|142892665|SUPERIORITY|||||||0.1642|||||||Regression, Linear|||||||0.1642
71688376|NCT01884545|142892666|SUPERIORITY|||||||0.8027|||||||Regression, Linear|||||||0.8027
71881974|NCT03631732|143282982|SUPERIORITY|||||||0.3532|||||||Fisher Exact|||||||0.3532
71921295|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.1||||0.436|TWO_SIDED|95.0|-0.5|0.2|||Mixed Models Analysis|||Least Pain||0.2|-0.5|.436
71921296|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|0.1||||0.534|TWO_SIDED|95.0|-0.2|0.5|||Mixed Models Analysis|||Average Pain||0.5|-0.2|.534
71921297|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|0.0||||0.948|TWO_SIDED|95.0|-0.4|0.4|||Mixed Models Analysis|||Pain Right Now||0.4|-0.4|.948
71921298|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.2||||0.225|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||General Activity||0.1|-0.6|.225
71688377|NCT01884545|142892666|SUPERIORITY|||||||0.7751|||||||Regression, Linear|||||||0.7751
71921299|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.2||||0.276|TWO_SIDED|95.0|-0.6|0.2|||Mixed Models Analysis|||Mood||0.2|-0.6|.276
71921300|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.1||||0.507|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||Walking Ability||0.2|-0.4|.507
71921301|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.2||||0.216|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Normal Work||0.1|-0.5|.216
71921302|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.2||||0.233|TWO_SIDED|95.0|-0.4|0.1|||Mixed Models Analysis|||Relations with other people||0.1|-0.4|.233
71688378|NCT01884545|142892667|SUPERIORITY|||||||0.5557|||||||Regression, Linear|||||||0.5557
71688379|NCT01884545|142892667|SUPERIORITY|||||||0.7834|||||||Regression, Linear|||||||0.7834
71688380|NCT01884545|142892668|SUPERIORITY|||||||0.1439|||||||Regression, Linear|||||||0.1439
71688381|NCT01884545|142892668|SUPERIORITY|||||||0.2275|||||||Regression, Linear|||||||0.2275
71688382|NCT01884545|142892669|SUPERIORITY|||||||0.7639|||||||Regression, Linear|||||||0.7639
71688383|NCT01884545|142892669|SUPERIORITY|||||||0.9999|||||||Regression, Linear|||||||0.9999
71688384|NCT01884545|142892670|SUPERIORITY|||||||0.4673|||||||Regression, Linear|||||||0.4673
71688385|NCT01884545|142892670|SUPERIORITY|||||||0.2297|||||||Regression, Linear|||||||0.2297
71688386|NCT01884545|142892671|SUPERIORITY|||||||0.2192|||||||Regression, Linear|||||||0.2192
71688387|NCT01884545|142892671|SUPERIORITY|||||||0.9062|||||||Regression, Linear|||||||0.9062
71688388|NCT01884545|142892672|SUPERIORITY|||||||0.1466|||||||Regression, Linear|||||||0.1466
71688389|NCT01884545|142892672|SUPERIORITY|||||||0.207|||||||Regression, Linear|||||||0.2070
71688390|NCT01884545|142892673|SUPERIORITY|||||||0.6289|||||||Regression, Linear|||||||0.6289
71881975|NCT03631732|143282983|NON_INFERIORITY|B/F/TAF is non-inferior to SBR if the lower bound of the 2-sided 95% CI of the difference between treatment groups \[B/F/TAF - SBR\] in the percentage of participants with HIV-1 RNA \< 50 copies/mL is greater than -10% (i.e., a margin of 10% is applied to non-inferiority assessment).|Difference in percentages|1.4|||||TWO_SIDED|95.0|-1.0|5.3|||||Differences in percentages of participants with HIV-1 RNA \< 50 copies/mL between treatment groups and 95% CI were calculated based on exact method.|||5.3|-1.0|
71921303|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|0.0||||0.857|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||Sleep||0.3|-0.3|.857
71921304|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.2||||0.133|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||Enjoyment of life||0.1|-0.5|.133
71921305|NCT02417935|143363650|OTHER||Mean Difference (Final Values)|-0.16||||0.246|TWO_SIDED|95.0|-0.44|0.11|||Mixed Models Analysis|||Average Interference Score||0.11|-0.44|.246
71921306|NCT02417935|143363651|OTHER||Mean Difference (Final Values)|-0.7||||0.627|TWO_SIDED|95.0|-3.6|2.2|||ANCOVA|||Total Score||2.2|-3.6|.627
71921307|NCT02417935|143363651|OTHER||Mean Difference (Final Values)|-0.2||||0.355|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Burning Pain||0.2|-0.6|.355
71921308|NCT02417935|143363651|OTHER||Mean Difference (Final Values)|0.1||||0.731|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Pressing Pain||0.4|-0.3|.731
71688391|NCT01884545|142892673|SUPERIORITY|||||||0.9631|||||||Regression, Linear|||||||0.9631
71688392|NCT01884545|142892674|SUPERIORITY|||||||0.2313|||||||Regression, Linear|||||||0.2313
71688393|NCT01884545|142892674|SUPERIORITY|||||||0.8029|||||||Regression, Linear|||||||0.8029
71688394|NCT01884545|142892675|SUPERIORITY|||||||0.071|||||||Regression, Linear|||||||0.0710
71688395|NCT01884545|142892675|SUPERIORITY|||||||0.8069|||||||Regression, Linear|||||||0.8069
71881976|NCT03631732|143282983|SUPERIORITY|||||||0.3356|||||||Fisher Exact|||||||0.3356
71881977|NCT03631732|143282985|OTHER||Difference in LSM|11.0||||0.5618|TWO_SIDED|95.0|-27.0|49.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM (Least square mean) and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||49|-27|0.5618
71881978|NCT03631732|143282986|OTHER||Difference in LSM|9.0||||0.6632|TWO_SIDED|95.0|-31.0|48.0|||ANOVA|P-value was calculated from ANOVA model with treatment as a fixed effect.|Difference in LSM and its 95% C.I. was calculated from ANOVA model with treatment as a fixed effect.|||48|-31|0.6632
71881979|NCT00768521|143283005|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.18||||0.008||90.0|7.58|41.06||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|Primary Hypothesis: Tolterodine LA 4 mg is superior to placebo with respect to change from baseline in maximum cystometric capacity at 4 hours post Dose 7 (i.e., steady state). The expected treatment effect is targeted at 40 mL.|||41.06|7.58|0.008
71921309|NCT02417935|143363651|OTHER||Mean Difference (Final Values)|0.1||||0.721|TWO_SIDED|95.0|-0.3|0.4|||ANCOVA|||Paroxysmal Pain||0.4|-0.3|.721
71921310|NCT02417935|143363651|OTHER||Mean Difference (Final Values)|-0.2||||0.345|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Evoked Pain||0.2|-0.5|.345
71921311|NCT02417935|143363651|OTHER||Mean Difference (Final Values)|-0.1||||0.557|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Paresthesia/Dysesthesia||0.3|-0.5|.557
71921312|NCT02417935|143363652|OTHER||Mean Difference (Final Values)|-0.2||||0.106|TWO_SIDED|95.0|-0.4|0.0|||Mixed Models Analysis|||||0.0|-0.4|.106
71921313|NCT02417935|143363653|OTHER||Mean Difference (Final Values)|0.014||||0.361|TWO_SIDED|95.0|-0.0161|0.0441|||ANCOVA|||||0.0441|-0.0161|.361
71881980|NCT00768521|143283006|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63||||0.422||90.0|-11.5|16.71||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.||||16.71|-11.5|0.422
71881981|NCT02873936|143283013|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.5|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||46.3|23.5|<0.001
71921314|NCT02417935|143363654|OTHER||Mean Difference (Final Values)|0.2||||0.701|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|.701
71921315|NCT02417935|143363655|OTHER||Mean Difference (Final Values)|0.005||||0.976|TWO_SIDED|95.0|-0.355|0.366|||Mixed Models Analysis|||||0.366|-0.355|.976
71688396|NCT01884545|142892676|SUPERIORITY|||||||0.0512|||||||Chi-squared|||||||0.0512
71688397|NCT01884545|142892676|SUPERIORITY|||||||0.4478|||||||Chi-squared|||||||0.4478
71688398|NCT01884545|142892679|SUPERIORITY|||||||0.7923|||||||Regression, Linear|||Perceived Risk for CHD, Consequences subscale||||0.7923
71881982|NCT02873936|143283013|SUPERIORITY||Difference in Response Rates|26.4|||<|0.001|TWO_SIDED|95.0|15.0|37.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||37.9|15.0|<0.001
71881983|NCT02873936|143283014|SUPERIORITY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.066|<|0.001|TWO_SIDED|95.0|-0.45|-0.19||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.19|-0.45|<0.001
71881984|NCT02873936|143283014|SUPERIORITY||Least Squares Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.001|TWO_SIDED|95.0|-0.4|-0.14||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.14|-0.40|<0.001
71881985|NCT02873936|143283015|SUPERIORITY||Difference in Response Rates|25.3|||<|0.001|TWO_SIDED|95.0|14.7|35.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||35.8|14.7|<0.001
71881986|NCT02873936|143283015|SUPERIORITY||Difference in Response Rates|21.7|||<|0.001|TWO_SIDED|95.0|11.4|32.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||32.0|11.4|<0.001
71881987|NCT02873936|143283016|SUPERIORITY||Least Squares Mean Difference|4.3|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|2.5|6.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||6.1|2.5|<0.001
71921316|NCT02417935|143363656|OTHER||Mean Difference (Final Values)|0.136||||0.503|TWO_SIDED|95.0|-0.264|0.537|||Mixed Models Analysis|||||0.537|-0.264|.503
71921317|NCT02417935|143363657|OTHER|||||||0.632||||||30% reduction|Fisher Exact|||||||.632
71921318|NCT02417935|143363657|OTHER|||||||0.907|||||||Fisher Exact|||50% Reduction||||.907
71921319|NCT01899729|143363669|OTHER|Used mixed effects model||||||0.06|||||||Mixed Models Analysis|||||||0.06
71688399|NCT01884545|142892679|SUPERIORITY|||||||0.0636|||||||Regression, Linear|||Perceived Risk for CHD, Personal control||||0.0636
71688400|NCT01884545|142892679|SUPERIORITY|||||||0.2063|||||||Regression, Linear|||Perceived Risk for CHD, Treatment control||||0.2063
71688401|NCT01884545|142892679|SUPERIORITY|||||||0.2529|||||||Regression, Linear|||Perceived Risk for CHD, Emotional representations||||0.2529
71688402|NCT01884545|142892679|SUPERIORITY|||||||0.1085|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), Consequences subscale||||0.1085
71688403|NCT01884545|142892679|SUPERIORITY|||||||0.337|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), personal control subscale||||0.3370
71881988|NCT02873936|143283016|SUPERIORITY||Least Squares Mean Difference|3.4|STANDARD_ERROR_OF_MEAN|0.92|<|0.001|TWO_SIDED|95.0|1.6|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.6|<0.001
71881989|NCT02873936|143283017|SUPERIORITY||Difference in Response Rates|18.5|||<|0.001|TWO_SIDED|95.0|8.6|28.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||28.3|8.6|<0.001
71881990|NCT02873936|143283017|SUPERIORITY||Difference in Response Rates|14.0||||0.003|TWO_SIDED|95.0|4.6|23.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||23.4|4.6|0.003
71688404|NCT01884545|142892679|SUPERIORITY|||||||0.3483|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), treatment control subscale||||0.3483
71688405|NCT01884545|142892679|SUPERIORITY|||||||0.5384|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), emotional representations||||0.5384
71881991|NCT02873936|143283018|SUPERIORITY||Least Squares Mean Difference|5.0|STANDARD_ERROR_OF_MEAN|1.19|<|0.001|TWO_SIDED|95.0|2.6|7.3||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.3|2.6|<0.001
71921320|NCT01454531|143363693|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired values|t-test, 2 sided|||The null hypothesis is no changes in IgE-blocking factor values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in IgE-blocking factor values||||<0.001
71921321|NCT01454531|143363694|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Paired samples|t-test, 2 sided|||The null hypothesis is no changes in Phleum specific IgG4 values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in Phleum specific IgG4 values||||<0.001
71881992|NCT02873936|143283018|SUPERIORITY||Least Squares Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|1.18||0.007|TWO_SIDED|95.0|0.9|5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.5|0.9|0.007
71881993|NCT02873936|143283019|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.4|23.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||23.7|6.4|<0.001
71881994|NCT02873936|143283019|SUPERIORITY||Difference in Response Rates|14.1|||<|0.001|TWO_SIDED|95.0|5.7|22.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||22.6|5.7|<0.001
71921322|NCT01454531|143363695|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Parallel Line Assay|||Parallel Line Assay is based on the construction of two dose-response regression lines obtained plotting the allergen concentration used to prick test the subjects against the wheal size obtained. ANOVA allows to check for regression, linearity and parallelism. A common slope and y-intercepts are calculated. The CTI is the exponentiation of the difference between y-intercepts divided by the common slope. (Finney D.J., Statistical Method in Biological Assay, 1978).||||<0.01
71921323|NCT00890396|143363702|SUPERIORITY|||||||0.67|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||0.67
71921324|NCT00890396|143363703|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||The primary analysis compared the frequency of worsening spleen function (from normal to decreased or absent, or from decreased to absent).||||>0.99
71921325|NCT00890396|143363704|SUPERIORITY|||||||0.61|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.61
71688406|NCT01884545|142892680|SUPERIORITY|||||||0.7447|||||||Regression, Linear|||Perceived Risk for T2D, Consequences subscale||||0.7447
71881995|NCT02873936|143283019|SUPERIORITY||Difference in Response Rates|28.0|||<|0.001|TWO_SIDED|95.0|17.5|38.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||38.5|17.5|<0.001
71881996|NCT02873936|143283019|SUPERIORITY||Difference in Response Rates|17.2|||<|0.001|TWO_SIDED|95.0|7.1|27.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||27.2|7.1|<0.001
71881997|NCT02873936|143283019|SUPERIORITY||Difference in Response Rates|26.7|||<|0.001|TWO_SIDED|95.0|15.8|37.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||37.6|15.8|<0.001
71881998|NCT02873936|143283019|SUPERIORITY||Difference in Response Rates|16.4||||0.002|TWO_SIDED|95.0|5.9|26.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||26.9|5.9|0.002
71881999|NCT02873936|143283020|SUPERIORITY||Difference in Response Rates|3.4||||0.16|TWO_SIDED|95.0|-1.9|8.8||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||8.8|-1.9|0.16
71882000|NCT02873936|143283020|SUPERIORITY||Difference in Response Rates|5.8||||0.039|TWO_SIDED|95.0|0.0|11.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||11.6|-0.0|0.039
71882001|NCT02873936|143283020|SUPERIORITY||Difference in Response Rates|15.0|||<|0.001|TWO_SIDED|95.0|6.5|23.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12||23.5|6.5|<0.001
71882002|NCT02873936|143283020|SUPERIORITY||Difference in Response Rates|7.6||||0.036|TWO_SIDED|95.0|0.1|15.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12||15.2|0.1|0.036
71882003|NCT02873936|143283020|SUPERIORITY||Difference in Response Rates|23.9|||<|0.001|TWO_SIDED|95.0|14.5|33.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||33.3|14.5|<0.001
71921326|NCT00890396|143363705|SUPERIORITY|||||||0.78|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.78
71921327|NCT00890396|143363706|SUPERIORITY|||||||0.8|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.80
71882004|NCT02873936|143283020|SUPERIORITY||Difference in Response Rates|12.2||||0.004|TWO_SIDED|95.0|3.7|20.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||20.6|3.7|0.004
71882005|NCT02873936|143283021|SUPERIORITY||Difference in Response Rates|26.0|||<|0.001|TWO_SIDED|95.0|14.6|37.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4||37.4|14.6|<0.001
71882006|NCT02873936|143283021|SUPERIORITY||Difference in Response Rates|18.8|||<|0.001|TWO_SIDED|95.0|7.5|30.0||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4||30.0|7.5|<0.001
71882007|NCT02873936|143283021|SUPERIORITY||Difference in Response Rates|34.9|||<|0.001|TWO_SIDED|95.0|23.6|46.3||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24||46.3|23.6|<0.001
71882008|NCT02873936|143283021|SUPERIORITY||Difference in Response Rates|20.4|||<|0.001|TWO_SIDED|95.0|8.8|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24||32.1|8.8|<0.001
71882009|NCT02873936|143283022|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.4||0.003|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.003
71882010|NCT02873936|143283022|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.4||0.027|TWO_SIDED|95.0|-6.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-6.0|0.027
71882011|NCT02873936|143283022|SUPERIORITY||Least Squares Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-8.0|-3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-3.0|-8.0|<0.001
71921328|NCT00890396|143363707|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
71921329|NCT00890396|143363708|SUPERIORITY|||||||0.85|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.85
71921330|NCT00890396|143363709|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.95
71921331|NCT00890396|143363710|SUPERIORITY|||||||0.4|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.40
71921332|NCT00890396|143363711|SUPERIORITY|||||||0.11|||||||Kruskal-Wallis|||Kruskal-Wallis test was used to test if there were a statistically significant difference between the two treatment groups.||||0.11
71688407|NCT01884545|142892680|SUPERIORITY|||||||0.6378|||||||Regression, Linear|||Perceived Risk for T2D, Personal control||||0.6378
71688408|NCT01884545|142892680|SUPERIORITY|||||||0.3209|||||||Regression, Linear|||Perceived Risk for T2D, Treatment control||||0.3209
71688409|NCT01884545|142892680|SUPERIORITY|||||||0.0058|||||||Regression, Linear|||Perceived Risk for T2D, Emotional representations||||0.0058
71688410|NCT01884545|142892680|SUPERIORITY|||||||0.3769|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), Consequences subscale||||0.3769
71688411|NCT01884545|142892680|SUPERIORITY|||||||0.0872|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), personal control||||0.0872
71688412|NCT01884545|142892680|SUPERIORITY|||||||0.4302|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), treatment control||||0.4302
71688413|NCT01884545|142892680|SUPERIORITY|||||||0.4133|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), emotional representations||||0.4133
71688414|NCT01884545|142892681|SUPERIORITY|||||||0.3106|||||||Regression, Linear|||||||0.3106
71882012|NCT02873936|143283022|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.3|<|0.001|TWO_SIDED|95.0|-7.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-7.0|<0.001
71882013|NCT02873936|143283022|SUPERIORITY||Least Squares Mean Difference|-7.0|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-10.0|-4.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.0|-10.0|<0.001
71688415|NCT01884545|142892681|SUPERIORITY|||||||0.7087|||||||Regression, Linear|||||||0.7087
71688416|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|1.034||||0.9259|TWO_SIDED|95.0|0.511|2.094|||Regression, Logistic|||Stages of Change, Weight reduction||2.094|0.511|0.9259
71688417|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|2.252||||0.0082|TWO_SIDED|95.0|1.234|4.111|||Regression, Logistic|||Stages of Change, Exercise behavior||4.111|1.234|0.0082
71688418|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|0.423||||0.2954|TWO_SIDED|95.0|0.084|2.12|||Regression, Logistic|||Stages of Change, Smoking behavior||2.120|0.084|0.2954
71688419|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|1.216||||0.5669|TWO_SIDED|95.0|0.622|2.376|||Regression, Logistic|||Stages of Change, Healthier eating behavior||2.376|0.622|0.5669
71688420|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|0.622||||0.121|TWO_SIDED|95.0|0.341|1.134|||Regression, Logistic|||Stages of Change, Stress behavior||1.134|0.341|0.1210
71688421|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|0.928||||0.8355|TWO_SIDED|95.0|0.461|1.872|||Regression, Logistic|||Weight reduction||1.872|0.461|0.8355
71688422|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0459|TWO_SIDED|95.0|1.011|3.311|||Regression, Logistic|||Exercise behavior||3.311|1.011|0.0459
71688423|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|0.563||||0.465|TWO_SIDED|95.0|0.121|2.629|||Regression, Logistic|||Smoking behavior||2.629|0.121|0.4650
71688424|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8303|TWO_SIDED|95.0|0.478|1.808|||Regression, Logistic|||Healthier eating behavior||1.808|0.478|0.8303
71688425|NCT01884545|142892682|SUPERIORITY||Odds Ratio (OR)|1.347||||0.3254|TWO_SIDED|95.0|0.744|2.439|||Regression, Logistic|||Stress behavior||2.439|0.744|0.3254
71688426|NCT01884545|142892683|SUPERIORITY|||||||0.0174|||||||Regression, Linear|||||||0.0174
71688427|NCT01884545|142892683|SUPERIORITY|||||||0.8694|||||||Regression, Linear|||||||0.8694
71688428|NCT01884545|142892684|SUPERIORITY|||||||0.4768|||||||Regression, Linear|||||||0.4768
71882014|NCT02873936|143283022|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.5||0.006|TWO_SIDED|95.0|-7.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-7.0|0.006
71688429|NCT01884545|142892684|SUPERIORITY|||||||0.8452|||||||Regression, Linear|||||||0.8452
71688430|NCT01884545|142892685|SUPERIORITY||Odds Ratio (OR)|1.591||||0.5589|TWO_SIDED|95.0|0.335|7.544|||Regression, Logistic|||||7.544|0.335|0.5589
71688431|NCT00519584|142892686|SUPERIORITY||Hazard Ratio (HR)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.39|||Log Rank||Ropivacaine/dex vs. Ropivacaine/saline|||0.39|0.08|<0.001
71688432|NCT00519584|142892686|SUPERIORITY||Hazard Ratio (HR)|0.44|||<|0.001|TWO_SIDED|95.0|0.23|0.83|||Log Rank||bupivacaine/dex vs. bupivacaine/Saline|||0.83|0.23|<0.001
71688433|NCT00519584|142892687|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71688434|NCT00519584|142892687|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71688435|NCT00519584|142892688|SUPERIORITY||||||<|0.001||||||adjusted significance level is 0.025|Wilcoxon (Mann-Whitney)|||||||<0.001
71688436|NCT00519584|142892688|SUPERIORITY|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||||||0.005
71688437|NCT00519584|142892689|SUPERIORITY|||||||0.29||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.29
71688438|NCT00519584|142892689|SUPERIORITY|||||||0.15||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)|||||||0.15
71688439|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688440|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688441|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688442|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71882015|NCT02873936|143283023|SUPERIORITY||Least Squares Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.008|TWO_SIDED|95.0|-5.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-5.0|0.008
71882016|NCT02873936|143283023|SUPERIORITY||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.0||0.65|TWO_SIDED|95.0|-2.0|1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||1.0|-2.0|0.65
71882017|NCT02873936|143283023|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
71882018|NCT02873936|143283023|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.008|TWO_SIDED|95.0|-4.0|-1.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.0|-4.0|0.008
71882019|NCT02873936|143283023|SUPERIORITY||Least Squares Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|0.9|<|0.001|TWO_SIDED|95.0|-5.0|-2.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.0|-5.0|<0.001
71882020|NCT02873936|143283023|SUPERIORITY||Least Squares Mean Difference|-2.0|STANDARD_ERROR_OF_MEAN|0.9||0.039|TWO_SIDED|95.0|-4.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.0|-4.0|0.039
71882021|NCT02873936|143283024|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
71882022|NCT02873936|143283024|SUPERIORITY||Least Squares Mean Difference|-11.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-16.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-16.0|<0.001
71921333|NCT02504424|143363712|OTHER||percent of breasts successfully exchange|100.0|||||ONE_SIDED|||||||||Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts - 6 breasts). Failed exchange = 4 breasts (non-device related) \& Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).||||
71921334|NCT02504424|143363712|OTHER||% breasts successfully exchanged|100.0|||||ONE_SIDED|||||||||Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.||||
71688443|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71882023|NCT02873936|143283024|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-24.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-24.0|<0.001
71882024|NCT02873936|143283024|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.0|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
71921335|NCT02504424|143363713|OTHER||% breasts successfully exchanged|95.2|||||ONE_SIDED|||||||||Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.||||
71688444|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688445|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688446|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688447|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688448|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71882025|NCT02873936|143283024|SUPERIORITY||Least Squares Mean Difference|-18.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-25.0|-12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-12.0|-25.0|<0.001
71882026|NCT02873936|143283024|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.0|-19.0|<0.001
71882027|NCT02873936|143283025|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-17.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|Mixed effects model for repeated measure|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-17.0|<0.001
71921336|NCT00440232|143363714|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.969||||0.172|TWO_SIDED|95.0|0.74|5.235|||Chi-squared|||||5.235|0.74|0.172
71921337|NCT00440232|143363715|SUPERIORITY_OR_OTHER||log rank chi square|1.247||||0.264||95.0|||||Log Rank|df=1||||||0.264
71921338|NCT00362297|143363717|SUPERIORITY_OR_OTHER_LEGACY||Incident Risk Ratio|0.79||||0.052||95.0|0.63|1.0|||Regression, Poisson|Adjusted for period effects.||Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.||1.00|0.63|0.052
71921339|NCT01259388|143363728|SUPERIORITY_OR_OTHER_LEGACY|||||||0.346|||||||t-test, 2 sided|||||||0.346
71688449|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688450|NCT00524680|142892720|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.||||<.0001
71688451|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.8244|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.8244
71688452|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.1025|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 4000 IU. Statistical analysis was done using one sample t-test.||||0.1025
71688453|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.1744|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU.||||0.1744
71688454|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.1281|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.1281
71688455|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.9688|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test.||||0.9688
71688456|NCT00524680|142892721|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test.||||<0.0001
71688457|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.8241|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.8241
71688458|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.1828|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1828
71688459|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.1348|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test.||||0.1348
71921340|NCT01259388|143363730|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71921341|NCT02743494|143363733|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.0003|TWO_SIDED|96.4|0.56|0.86|||Stratified log-rank test||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.|||0.86|0.56|0.0003
71921342|NCT01032265|143363755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27||95.0|||||Mixed Models Analysis|||analysis between groups||||0.27
71921343|NCT01032265|143363756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.52||95.0|||||Mixed Models Analysis|||analysis between groups||||0.52
71921344|NCT01032265|143363757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3||95.0|||||Mixed Models Analysis|||analysis between groups||||0.30
71921345|NCT01032265|143363758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.02
71921346|NCT01032265|143363759|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||<0.001
71688460|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.2214|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.2214
71688461|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.0079|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0079
71688462|NCT00524680|142892721|SUPERIORITY_OR_OTHER|||||||0.0631|TWO_SIDED||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test.||||0.0631
71688463|NCT00856843|142892754|SUPERIORITY_OR_OTHER||Difference in success rates|8.8||||0.038|TWO_SIDED|95.0|0.9|16.8|||Chi-squared|||||16.8|0.9|0.038
71688464|NCT00856843|142892755|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||||||0.010
71688465|NCT00856843|142892756|SUPERIORITY_OR_OTHER|||||||0.02|||||||Chi-squared|||||||0.020
71688466|NCT00856843|142892757|SUPERIORITY_OR_OTHER|||||||0.644|||||||Chi-squared|||||||0.644
71882028|NCT02873936|143283025|SUPERIORITY||Least Squares Mean Difference|-10.0|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-15.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-15.0|<0.001
71882029|NCT02873936|143283025|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-22.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-22.0|<0.001
71921347|NCT01032265|143363760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23||95.0|||||negative binomial regression|||analysis between groups||||0.23
71921348|NCT01032265|143363761|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0|||||Wilcoxon (Mann-Whitney)|||analysis between groups||||0.01
71921349|NCT02728804|143363763|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.65|TWO_SIDED|95.0|0.66|1.29|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.29|0.66|0.65
71921350|NCT02728804|143363764|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.7|TWO_SIDED|95.0|0.79|1.43|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.43|0.79|0.70
71688467|NCT00856843|142892758|SUPERIORITY_OR_OTHER|||||||0.763|||||||Chi-squared|||||||0.763
71688468|NCT00856843|142892759|SUPERIORITY_OR_OTHER|||||||0.173|||||||Chi-squared|||||||0.173
71688469|NCT00856843|142892760|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||||||0.004
71688470|NCT00856843|142892761|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71688471|NCT00856843|142892762|SUPERIORITY_OR_OTHER|||||||0.005|||||||Chi-squared|||||||0.005
71688472|NCT00856843|142892763|SUPERIORITY_OR_OTHER|||||||0.013|||||||Chi-squared|||||||0.013
71688473|NCT00856843|142892764|SUPERIORITY_OR_OTHER|||||||0.283|||||||Chi-squared|||||||0.283
71688474|NCT03078127|142892768|SUPERIORITY|||||||0.615||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for statistical significance was set to 0.05|ANOVA|||No comparable preliminary data exists on mucociliary clearance (MCC) in response to airway clearance therapy methods (ACTs) for a power calculation. However, prior studies of medication effect on MCC gave a baseline mean change of Ave270 clr of 27.7% (std dev of 15.1%). Thus, the investigators estimated a mean change of 20% for effective ACT with the same estimate for variability (Std Dev of 15.1%). Using a paired 2-tailed test to compare means, 7 subjects were estimated to be needed.||||0.615
71688475|NCT03078127|142892769|SUPERIORITY|||||||0.696||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for significance was \< 0.05.|ANOVA|||||||0.696
71688476|NCT03078127|142892771|SUPERIORITY|||||||0.001||||||The a priori threshold of statistical significance was p = 0.05|t-test, 2 sided|||The investigators compared FENO before and after ACT in a pooled manner (i.e., grouping each of the comparisons together), as the study was not powered for FENO comparisons within each ACT type.||||0.001
71688477|NCT03078127|142892771|OTHER|A linear regression was performed between change in FENO and Ave90Clr||||||0.692||||||The a priori threshold for statistical significance (i.e., slope different than zero) between MCC and FENO was 0.05|Regression, Linear|||if the difference between pre and post-ACT FENO was significant (defined as p\<0.05), it was investigated whether change in FENO correlated with MCC (as represented by Ave90Clr)||||0.692
71688478|NCT03078127|142892772|SUPERIORITY|||||||0.146||||||Non-parametric test used due to lack of data normality. The a prior threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.146
71688479|NCT03078127|142892773|SUPERIORITY|||||||0.041||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.041
71688480|NCT03078127|142892773|OTHER|A linear regression was performed between change in pre and post-ACT adenosine (purine) in EBC and Ave90Clr||||||0.047||||||The a priori threshold of statistical significance was p = 0.05|Regression, Linear|||If the difference between pre and post-ACT adenosine (purine) in EBC was significant (defined as p\<0.05), the correlation between change in adenosine concentration and MCC (as represented by Ave90Clr) was investigated.||||0.047
71688481|NCT03078127|142892774|SUPERIORITY|||||||0.07||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was \< 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.||||0.070
71921351|NCT02728804|143363765|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.87|TWO_SIDED|95.0|0.73|1.31|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.31|0.73|0.87
71882030|NCT02873936|143283025|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-18.0|<0.001
71882031|NCT02873936|143283025|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-18.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-18.0|<0.001
71882032|NCT02873936|143283025|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|2.7||0.052|TWO_SIDED|95.0|-11.0|0.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||0.0|-11.0|0.052
71882033|NCT02873936|143283026|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-21.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-21.0|<0.001
71882034|NCT02873936|143283026|SUPERIORITY||Least Squares Mean Difference|-14.0|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-19.0|-8.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-8.0|-19.0|<0.001
71882035|NCT02873936|143283026|SUPERIORITY||Least Squares Mean Difference|-17.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-23.0|-11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-11.0|-23.0|<0.001
71882036|NCT02873936|143283026|SUPERIORITY||Least Squares Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-19.0|-7.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.0|-19.0|<0.001
71882037|NCT02873936|143283026|SUPERIORITY||Least Squares Mean Difference|-16.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-23.0|-10.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-10.0|-23.0|<0.001
71882038|NCT02873936|143283026|SUPERIORITY||Least Squares Mean Difference|-12.0|STANDARD_ERROR_OF_MEAN|3.4|<|0.001|TWO_SIDED|95.0|-19.0|-5.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.0|-19.0|<0.001
71882039|NCT02873936|143283027|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.055|<|0.001|TWO_SIDED|95.0|-0.33|-0.11||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.11|-0.33|<0.001
71921352|NCT02728804|143363766|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.01|TWO_SIDED|95.0|0.48|0.92|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||0.92|0.48|0.01
71921353|NCT02728804|143363767|SUPERIORITY||Hazard Ratio (HR)|1.33||||0.1|TWO_SIDED|95.0|0.95|1.87|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||1.87|0.95|0.10
71921354|NCT02728804|143363767|SUPERIORITY||Hazard Ratio (HR)|1.92||||0.002|TWO_SIDED|95.0|1.28|2.89|||Regression, Cox|Covariate adjustment for insurance status, education, and sex.||||2.89|1.28|0.002
71921355|NCT02475564|143363786|SUPERIORITY_OR_OTHER|||||||0.7|||||||Mann-Whitney test|||A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.||||0.7
71688482|NCT01451554|142892785|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||2 tailed t-test|t-test, 2 sided|||Data were compared between groups using the 2 sample T-test.||||0.06
71882040|NCT02873936|143283027|SUPERIORITY||Least Squares Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.055||0.006|TWO_SIDED|95.0|-0.26|-0.04||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.04|-0.26|0.006
71882041|NCT02873936|143283027|SUPERIORITY||Least Squares Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.075|<|0.001|TWO_SIDED|95.0|-0.51|-0.21||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.21|-0.51|<0.001
71882042|NCT02873936|143283027|SUPERIORITY||Least Squares Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.075||0.003|TWO_SIDED|95.0|-0.37|-0.08||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.08|-0.37|0.003
71882043|NCT02873936|143283028|SUPERIORITY||Least Squares Mean Difference|-10.51|STANDARD_ERROR_OF_MEAN|1.578|<|0.001|TWO_SIDED|95.0|-13.61|-7.41||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.41|-13.61|<0.001
71882044|NCT02873936|143283028|SUPERIORITY||Least Squares Mean Difference|-8.92|STANDARD_ERROR_OF_MEAN|1.577|<|0.001|TWO_SIDED|95.0|-12.02|-5.82||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.82|-12.02|<0.001
71882045|NCT02873936|143283028|SUPERIORITY||Least Squares Mean Difference|-10.94|STANDARD_ERROR_OF_MEAN|1.652|<|0.001|TWO_SIDED|95.0|-14.19|-7.69||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.69|-14.19|<0.001
71882046|NCT02873936|143283028|SUPERIORITY||Least Squares Mean Difference|-8.98|STANDARD_ERROR_OF_MEAN|1.651|<|0.001|TWO_SIDED|95.0|-12.22|-5.73||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.73|-12.22|<0.001
71921356|NCT02475564|143363787|SUPERIORITY_OR_OTHER|||||||0.1|||||||Mann-Whitney test|||||||0.1
71882047|NCT02873936|143283028|SUPERIORITY||Least Squares Mean Difference|-9.87|STANDARD_ERROR_OF_MEAN|1.964|<|0.001|TWO_SIDED|95.0|-13.73|-6.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.00|-13.73|<0.001
71882048|NCT02873936|143283028|SUPERIORITY||Least Squares Mean Difference|-6.89|STANDARD_ERROR_OF_MEAN|1.987|<|0.001|TWO_SIDED|95.0|-10.8|-2.98||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.98|-10.80|<0.001
71921357|NCT02475564|143363788|SUPERIORITY_OR_OTHER|||||||0.8|||||||Mann-Whitney test|||||||0.8
71921358|NCT02988115|143363813|SUPERIORITY||Least squares means difference|-21.41|STANDARD_ERROR_OF_MEAN|1.897|<|0.001|TWO_SIDED|95.0|-25.132|-17.697|||ANCOVA||bempedoic acid (BA) therapy minus placebo|||-17.697|-25.132|<0.001
71921359|NCT02988115|143363814|SUPERIORITY||Least squares means difference|-18.91|STANDARD_ERROR_OF_MEAN|2.063|<|0.001|TWO_SIDED|95.0|-22.951|-14.865|||ANCOVA||BA therapy minus placebo|||-14.865|-22.951|<0.001
71921360|NCT02988115|143363815|SUPERIORITY||Least squares means difference|-17.94|STANDARD_ERROR_OF_MEAN|1.597|<|0.001|TWO_SIDED|95.0|-21.07|-14.811|||ANCOVA||BA therapy minus placebo|non-HDL-C||-14.811|-21.070|<0.001
71921361|NCT02988115|143363815|SUPERIORITY||Least squares means difference|-14.76|STANDARD_ERROR_OF_MEAN|1.287|<|0.001|TWO_SIDED|95.0|-17.283|-12.239|||ANCOVA||BA therapy minus placebo|TC||-12.239|-17.283|<0.001
71688483|NCT01451554|142892786|SUPERIORITY_OR_OTHER|||||||0.31||95.0|||||t-test, 2 sided|||Data were compared between groups using a 2 sample T-test.||||0.31
71688484|NCT01402986|142892787|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.709|TWO_SIDED|95.0|0.67|1.31|||Poisson regression|||The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus \[vs\] more than \[\>\] 2 but less than or equal to \[=\<\] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.||1.31|0.67|0.709
71921362|NCT02988115|143363815|SUPERIORITY||Least squares means difference|-14.96|STANDARD_ERROR_OF_MEAN|1.581|<|0.001|TWO_SIDED|95.0|-18.062|-11.866|||ANCOVA||BA therapy minus placebo|apoB||-11.866|-18.062|<0.001
71921363|NCT02988115|143363816|SUPERIORITY||Median treatment difference|-24.29|STANDARD_ERROR_OF_MEAN|-24.3|<|0.001|TWO_SIDED|95.0|-35.888|-12.712|||Wilcoxon rank sum test||BA therapy minus placebo|||-12.712|-35.888|<0.001
71921364|NCT03287089|143363836|SUPERIORITY||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.49|2.43|||Chi-squared|||||2.43|0.49|0.84
71921365|NCT03287089|143363837|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.44
71921366|NCT03287089|143363838|SUPERIORITY|||||||0.68|||||||t-test, 1 sided|||||||0.68
71921367|NCT00661362|143363839|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.55|-0.29|||ANCOVA|||||-0.29|-0.55|<0.0001
71921368|NCT00661362|143363840|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|0.149|<|0.0002|TWO_SIDED|95.0|-0.85|-0.26|||ANCOVA|||||-0.26|-0.85|<0.0002
71921369|NCT00661362|143363841|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-10.1|STANDARD_ERROR_OF_MEAN|2.684|<|0.0002|TWO_SIDED|95.0|-15.37|-4.83|||ANCOVA|||||-4.83|-15.37|<0.0002
71921370|NCT00661362|143363842|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-155.0|STANDARD_ERROR_OF_MEAN|55.0||0.0052|TWO_SIDED|95.0|-264.0|-47.0|||ANCOVA|||||-47|-264|0.0052
71921371|NCT00661362|143363843|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2802.0|STANDARD_ERROR_OF_MEAN|989.8||0.0052|TWO_SIDED|95.0|-4753.0|-852.0|||ANCOVA|||||-852|-4753|0.0052
71921372|NCT00661362|143363844|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.1|||<|0.0001|TWO_SIDED|95.0|8.0|24.0|||ANCOVA|||||24.0|8.0|<0.0001
71921373|NCT04880642|143363855|SUPERIORITY|"The null hypothesis was that the there was no difference in survival up to Day 60 between the two groups and was to be rejected in favour of the alternative hypothesis i.e. a difference in survival up to Day 60 between the two groups excisted.~The overall 2-sided significance level of 5% was applied to the primary endpoint."|Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.4|2.36|||Log Rank|||||2.36|0.40|0.949
71921374|NCT04880642|143363856|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.301|TWO_SIDED|95.0|0.91|1.52|||Log Rank|||||1.52|0.91|0.301
71921375|NCT04880642|143363857|SUPERIORITY||Median Difference (Final Values)|0.0||||0.425|TWO_SIDED|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||||1|-1|0.425
71921376|NCT04880642|143363858|SUPERIORITY||Risk Difference (RD)|-1.7|STANDARD_ERROR_OF_MEAN|3.91||0.671|TWO_SIDED|95.0|-9.3|6.0|||Regression, Logistic|||||6.0|-9.3|0.671
71921377|NCT04880642|143363859|SUPERIORITY||Risk Difference (RD)|-0.4|STANDARD_ERROR_OF_MEAN|5.62||0.948|TWO_SIDED|95.0|-11.4|10.6|||Regression, Logistic|||||10.6|-11.4|0.948
71921378|NCT00104299|143363860|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin of -20%|Difference between group success rates|10.6|||<|0.001||95.1|-3.2|24.3||P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O'Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.|95.1% CI of difference|Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.||In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.||24.3|-3.2|<0.001
71688485|NCT01402986|142892787|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.904|TWO_SIDED|95.0|0.71|1.46|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \> 2 but =\< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.46|0.71|0.904
71688486|NCT01402986|142892804|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.293|TWO_SIDED|95.0|0.26|1.51|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.51|0.26|0.293
71882049|NCT02873936|143283029|SUPERIORITY||Difference in Response Rates|20.1|||<|0.001|TWO_SIDED|95.0|8.1|32.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||32.1|8.1|<0.001
71882050|NCT02873936|143283029|SUPERIORITY||Difference in Response Rates|14.5||||0.013|TWO_SIDED|95.0|2.4|26.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||26.5|2.4|0.013
71882051|NCT02873936|143283029|SUPERIORITY||Difference in Response Rates|22.2|||<|0.001|TWO_SIDED|95.0|10.3|34.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||34.1|10.3|<0.001
71882052|NCT02873936|143283029|SUPERIORITY||Difference in Response Rates|21.8|||<|0.001|TWO_SIDED|95.0|10.0|33.6||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||33.6|10.0|<0.001
71882053|NCT02873936|143283029|SUPERIORITY||Difference in Response Rates|33.3|||<|0.001|TWO_SIDED|95.0|21.8|44.9||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||44.9|21.8|<0.001
71882054|NCT02873936|143283029|SUPERIORITY||Difference in Response Rates|18.6||||0.001|TWO_SIDED|95.0|6.8|30.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||30.5|6.8|0.001
71882055|NCT02873936|143283030|SUPERIORITY||Least Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-1.1|-0.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.6|-1.1|<0.001
71688487|NCT01402986|142892804|SUPERIORITY_OR_OTHER||Rate Ratio|0.62||||0.27|TWO_SIDED|95.0|0.27|1.44|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.||1.44|0.27|0.270
71688488|NCT01402986|142892805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.257|TWO_SIDED|95.0|0.57|1.16|||Regression, Cox|||||1.16|0.57|0.257
71688489|NCT01402986|142892805|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.225|TWO_SIDED|95.0|0.56|1.15|||Regression, Cox|||||1.15|0.56|0.225
71922497|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.5||||0.205|TWO_SIDED|95.0|-2.3|7.4|||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.4|-2.3|0.205
71922498|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Week 8: Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the cochran method.||0.0|0.0|
71922499|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|4.0||||0.125|TWO_SIDED|95.0|-1.3|9.4|||Cochran-Mantel-Haenszel|||Week 8:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||9.4|-1.3|0.125
71922500|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|5.0||||0.071|TWO_SIDED|95.0|-1.7|11.8|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||11.8|-1.7|0.071
71922501|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.317|TWO_SIDED|95.0|-1.2|5.1|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.1|-1.2|0.317
71922502|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|2.0||||0.28|TWO_SIDED|95.0|-1.6|5.6|||Cochran-Mantel-Haenszel|||Week 10:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||5.6|-1.6|0.280
71922503|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|0.6||||0.892|TWO_SIDED|95.0|-7.6|8.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||8.8|-7.6|0.892
71922504|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-0.5||||0.903|TWO_SIDED|95.0|-8.3|7.2|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||7.2|-8.3|0.903
71688490|NCT01402986|142892806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79||||0.538|TWO_SIDED|95.0|0.37|1.68|||Regression, Cox|||||1.68|0.37|0.538
71688491|NCT01402986|142892806|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.561|TWO_SIDED|95.0|0.37|1.71|||Regression, Cox|||||1.71|0.37|0.561
71688492|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.73||||0.19|TWO_SIDED|95.0|0.46|1.17|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.17|0.46|0.190
71688493|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.856|TWO_SIDED|95.0|0.56|1.61|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= median||1.61|0.56|0.856
71688494|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|1.13||||0.602|TWO_SIDED|95.0|0.71|1.81|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.81|0.71|0.602
71688495|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.703|TWO_SIDED|95.0|0.55|1.5|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< median||1.50|0.55|0.703
71688496|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.455|TWO_SIDED|95.0|0.58|1.28|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.28|0.58|0.455
71922505|NCT00883896|143365380|SUPERIORITY_OR_OTHER_LEGACY||Percent Difference|-1.7||||0.625|TWO_SIDED|95.0|-7.2|3.8|||Cochran-Mantel-Haenszel|||Week 12:P-value was assessed from 2-sided CMH test stratified by anti-TNF prior use and geographic region of the site. Treatment group differences and the corresponding confidence intervals adjusted for stratification were calculated using the Cochran method.||3.8|-7.2|0.625
71688497|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|1.02||||0.929|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 25th Percentile||1.57|0.66|0.929
71688498|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.507|TWO_SIDED|95.0|0.63|2.51|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||2.51|0.63|0.507
71688499|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.805|TWO_SIDED|95.0|0.44|1.89|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 25th Percentile||1.89|0.44|0.805
71688500|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.716|TWO_SIDED|95.0|0.44|1.75|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||1.75|0.44|0.716
71688501|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|1.51||||0.328|TWO_SIDED|95.0|0.66|3.43|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \>= 75th Percentile||3.43|0.66|0.328
71688502|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.804|TWO_SIDED|95.0|0.64|1.41|||Poission regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.41|0.64|0.804
71688503|NCT01402986|142892807|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.088|TWO_SIDED|95.0|0.47|1.05|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin \< 75th Percentile||1.05|0.47|0.088
71688504|NCT01402986|142892808|SUPERIORITY_OR_OTHER||Rate Ratio|0.8||||0.365|TWO_SIDED|95.0|0.5|1.29|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.29|0.50|0.365
71688505|NCT01402986|142892808|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.922|TWO_SIDED|95.0|0.56|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.68|0.56|0.922
71922506|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.900
71922507|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.522|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.522
71922508|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.147|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.147
71688506|NCT01402986|142892808|SUPERIORITY_OR_OTHER||Rate Ratio|1.11||||0.685|TWO_SIDED|95.0|0.67|1.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.84|0.67|0.685
71882056|NCT02873936|143283030|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.9|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-0.9|<0.001
71882057|NCT02873936|143283030|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.5|-0.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.9|-1.5|<0.001
71882058|NCT02873936|143283030|SUPERIORITY||Least Squares Mean Difference|-1.0|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.3|-0.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.7|-1.3|<0.001
71921379|NCT00104299|143363861|SUPERIORITY_OR_OTHER|||||||0.927||||||P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model|Poisson regression model|||Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.||||0.927
71921380|NCT00104299|143363862|SUPERIORITY_OR_OTHER||95.1% Confidence Interval of Difference|10.6||||0.133|TWO_SIDED|95.1|-3.2|24.4|||Chi-squared|At 6 months, the confidence interval is 95.1%.||The p-value is from a chi-square test.||24.4|-3.2|0.133
71921381|NCT00104299|143363863|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.761|TWO_SIDED|95.0|0.5|1.7||The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission|Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.7|0.5|0.761
71921382|NCT00104299|143363864|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9||||0.861|TWO_SIDED|95.0|0.6|1.5|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit||1.5|0.6|0.861
71921383|NCT00104299|143363865|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.0||||0.497|TWO_SIDED|95.0|0.7|1.3|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.3|0.7|0.497
71921384|NCT00104299|143363866|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.147|TWO_SIDED|95.0|0.9|1.8|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.|||1.8|0.9|0.147
71921385|NCT00104299|143363867|SUPERIORITY_OR_OTHER|||||||0.504||95.0|||||Chi-squared|||Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.||||0.504
71921386|NCT00608426|143363904|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Logistic|||||||.02
71921387|NCT00608426|143363905|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of telephone counseling between the two groups|Mixed effects logistic regression|||||||<.001
71921388|NCT00608426|143363905|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED|||||for the comparison of in-person counseling between the two groups|Mixed effects logistic regression|||||||0.57
71921389|NCT00608426|143363905|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED|||||for the comparison of used medications between the two groups|Mixed effects logistic regression|||||||.15
71921390|NCT00608426|143363905|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||for the comparison of combination counseling and medication between the two groups|Mixed effects logistic regression|||||||<.001
71921391|NCT00608426|143363905|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED|||||for the comparison of attended VA smoking cessation clinic between the two groups|Mixed effects logistic regression|||||||.77
71921392|NCT00608426|143363905|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||for the comparison of received VA smoking cessation medication between the two groups|Mixed effects logistic regression|||||||.002
71688507|NCT01402986|142892808|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.813|TWO_SIDED|95.0|0.66|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.70|0.66|0.813
71921393|NCT00608426|143363906|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Regression, Logistic|||||||0.13
71921394|NCT02630459|143363915|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.89|||<|0.001|TWO_SIDED|95.0|-2.58|-1.2||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.20|-2.58|<0.001
71921395|NCT02630459|143363915|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.31|||<|0.001|TWO_SIDED|95.0|-3.0|-1.62||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.62|-3.00|<0.001
71921396|NCT02630459|143363915|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.25||||0.004|TWO_SIDED|95.0|-2.1|-0.41||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.41|-2.10|0.004
71921397|NCT02630459|143363916|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Full Administration||13.8|-13.3|
71921398|NCT02630459|143363916|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Not Full Administration||13.3|-13.8|
71921399|NCT02630459|143363916|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 4: Discontinued Investigational Product||13.3|-13.8|
71921400|NCT02630459|143363916|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.3|13.8|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Full Administration||13.8|-13.3|
71921401|NCT02630459|143363916|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Not Full Administration||13.3|-13.8|
71921402|NCT02630459|143363916|SUPERIORITY||Treatment Difference|0.0|||||TWO_SIDED|95.0|-13.8|13.3|||||The 95% CI for the difference was calculated using the Newcombe hybrid score method.|Week 8: Discontinued Investigational Product||13.3|-13.8|
71921403|NCT02630459|143363917|SUPERIORITY||Common Odds Ratio|4.73|||<|0.001|TWO_SIDED|95.0|2.24|9.99||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||9.99|2.24|<0.001
71921404|NCT02630459|143363917|SUPERIORITY||Common Odds Ratio|5.6|||<|0.001|TWO_SIDED|95.0|2.6|12.06||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||12.06|2.60|<0.001
71921405|NCT02630459|143363917|SUPERIORITY||Common Odds Ratio|3.21||||0.009|TWO_SIDED|95.0|1.3|7.88||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.||7.88|1.30|0.009
71921406|NCT02630459|143363918|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.04|||<|0.001|TWO_SIDED|95.0|-2.63|-1.45||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.45|-2.63|<0.001
71921407|NCT02630459|143363918|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.07|||<|0.001|TWO_SIDED|95.0|-2.66|-1.49||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-1.49|-2.66|<0.001
71882059|NCT02873936|143283030|SUPERIORITY||Least Squares Mean Difference|-1.1|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.5|-0.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.8|-1.5|<0.001
71882060|NCT02873936|143283030|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.17|<|0.001|TWO_SIDED|95.0|-1.1|-0.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-0.4|-1.1|<0.001
71882061|NCT02873936|143283031|SUPERIORITY||Difference in Response Rates|12.3||||0.004|TWO_SIDED|95.0|3.5|21.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||21.2|3.5|0.004
71882062|NCT02873936|143283031|SUPERIORITY||Difference in Response Rates|12.8||||0.003|TWO_SIDED|95.0|4.0|21.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||21.5|4.0|0.003
71882063|NCT02873936|143283031|SUPERIORITY||Difference in Response Rates|27.4|||<|0.001|TWO_SIDED|95.0|16.3|38.4||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 24.||38.4|16.3|<0.001
71882064|NCT02873936|143283031|SUPERIORITY||Difference in Response Rates|17.0||||0.001|TWO_SIDED|95.0|6.2|27.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 24.||27.7|6.2|0.001
71882065|NCT02873936|143283032|SUPERIORITY||Difference in Response Rates|7.5||||0.012|TWO_SIDED|95.0|1.3|13.7||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 4.||13.7|1.3|0.012
71921408|NCT02630459|143363918|SUPERIORITY|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.07||||0.004|TWO_SIDED|95.0|-1.8|-0.35||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure||-0.35|-1.80|0.004
71921409|NCT01453439|143363927|SUPERIORITY||Slope|-0.4602|STANDARD_ERROR_OF_MEAN|0.1249|<|0.01|TWO_SIDED|||||Degrees of freedom=90.9|Mixed Models Analysis|Effect of interest: time by group interaction|The estimated value describes the mean slope difference of CBT compared to SPT.|"We compared the difference in the rate of change in BDD symptom severity over time (during treatment phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||<.01
71922314|NCT00453349|143365042|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)||7.5|-8.1|
71882066|NCT02873936|143283032|SUPERIORITY||Difference in Response Rates|9.1||||0.006|TWO_SIDED|95.0|2.7|15.5||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 4.||15.5|2.7|0.006
71882067|NCT02873936|143283032|SUPERIORITY||Difference in Response Rates|14.3|||<|0.001|TWO_SIDED|95.0|5.6|23.1||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 200 mg vs Placebo at Week 12.||23.1|5.6|<0.001
71882068|NCT02873936|143283032|SUPERIORITY||Difference in Response Rates|17.4|||<|0.001|TWO_SIDED|95.0|8.5|26.2||P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.|Regression, Logistic|||Filgotinib 100 mg vs Placebo at Week 12.||26.2|8.5|<0.001
71882069|NCT02873936|143283035|SUPERIORITY||Least Squares Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|1.47|<|0.001|TWO_SIDED|95.0|-10.0|-4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.2|-10.0|<0.001
71882070|NCT02873936|143283035|SUPERIORITY||Least Squares Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.46|<|0.001|TWO_SIDED|95.0|-7.9|-2.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.2|-7.9|<0.001
71921410|NCT01453439|143363927|SUPERIORITY||Slope|-0.00984|STANDARD_ERROR_OF_MEAN|0.1038||0.62|TWO_SIDED|||||Degrees of freedom=74.7|Mixed Models Analysis|The effect of interest was the time by group interaction.|The estimated value describes the mean slope difference of CBT compared to SPT during follow-up (week 24 to week 50).|"We compared the difference in the rate of change in BDD symptom severity over time (during the follow-up phase) between the randomized treatment groups (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in BDD symptom severity during follow-up will not differ significantly between CBT and SPT treatments \[to be tested\]."||||.62
71921411|NCT01453439|143363928|SUPERIORITY|||||||0.1||||||Degrees of freedom=93.2|Mixed Models Analysis|||"We compared the change in Patient Insight over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.10
71921412|NCT01453439|143363928|SUPERIORITY|||||||0.45||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in Patient Insight over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in insight in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.45
71921413|NCT01453439|143363929|SUPERIORITY|||||||0.05||||||Degrees of freedom=89.1|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in depressive symptoms in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.05
71921414|NCT01453439|143363929|SUPERIORITY|||||||0.26||||||Degrees of freedom=63.7|Mixed Models Analysis|||"We compared the change in depressive symptoms over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depressive symptoms in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.26
71882071|NCT02873936|143283035|SUPERIORITY||Least Squares Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-12.6|-6.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.5|-12.6|<0.001
71882072|NCT02873936|143283035|SUPERIORITY||Least Squares Mean Difference|-7.6|STANDARD_ERROR_OF_MEAN|1.55|<|0.001|TWO_SIDED|95.0|-10.6|-4.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-4.5|-10.6|<0.001
71882073|NCT02873936|143283035|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.64|<|0.001|TWO_SIDED|95.0|-11.9|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.9|<0.001
71882074|NCT02873936|143283035|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|1.66||0.003|TWO_SIDED|95.0|-8.2|-1.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-1.6|-8.2|0.003
71882075|NCT02873936|143283036|SUPERIORITY||Least Squares Mean Difference|-8.1|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-11.1|-5.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.1|-11.1|<0.001
71882076|NCT02873936|143283036|SUPERIORITY||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|1.52|<|0.001|TWO_SIDED|95.0|-8.9|-2.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.9|-8.9|<0.001
71882077|NCT02873936|143283036|SUPERIORITY||Least Squares Mean Difference|-10.7|STANDARD_ERROR_OF_MEAN|1.6|<|0.001|TWO_SIDED|95.0|-13.8|-7.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-7.5|-13.8|<0.001
71882078|NCT02873936|143283036|SUPERIORITY||Least Squares Mean Difference|-8.7|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|-11.8|-5.5||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-5.5|-11.8|<0.001
71882079|NCT02873936|143283036|SUPERIORITY||Least Squares Mean Difference|-10.1|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-13.5|-6.8||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-6.8|-13.5|<0.001
71882080|NCT02873936|143283036|SUPERIORITY||Least Squares Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-9.4|-2.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||-2.7|-9.4|<0.001
71882081|NCT02873936|143283038|SUPERIORITY||Least Squares Mean Difference|2.5|STANDARD_ERROR_OF_MEAN|0.7|<|0.001|TWO_SIDED|95.0|1.1|3.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.9|1.1|<0.001
71882082|NCT02873936|143283038|SUPERIORITY||Least Squares Mean Difference|2.0|STANDARD_ERROR_OF_MEAN|0.7||0.005|TWO_SIDED|95.0|0.6|3.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.4|0.6|0.005
71882083|NCT02873936|143283038|SUPERIORITY||Least Squares Mean Difference|3.9|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|1.9|5.9||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.9|1.9|<0.001
71922509|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.534
71922510|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.206|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.206
71922511|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Cochran-Mantel-Haenszel|||Week 2: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.070
71922512|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.936|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.936
71922513|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.625
71922514|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.586|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.586
71922515|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.685|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.685
71922516|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.34|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.340
71922517|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.212|||||||Cochran-Mantel-Haenszel|||Week 4: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.212
71922518|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.455|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.455
71922519|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.145|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.145
71922520|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.660
71922521|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.050
71922522|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.428|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.428
71922523|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Cochran-Mantel-Haenszel|||Week 6: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.160
71922524|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.757|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.757
71922525|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.408|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.408
71922526|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.983|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.983
71922527|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.374|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.374
71922528|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.992|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.992
71922529|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.422|||||||Cochran-Mantel-Haenszel|||Week 8: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.422
71922530|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.743|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.743
71922531|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.188|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.188
71922532|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.385|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.385
71922533|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.148|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.148
71688508|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.335|TWO_SIDED|95.0|0.56|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.22|0.56|0.335
71882084|NCT02873936|143283038|SUPERIORITY||Least Squares Mean Difference|3.1|STANDARD_ERROR_OF_MEAN|1.03||0.002|TWO_SIDED|95.0|1.1|5.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.2|1.1|0.002
71882085|NCT02873936|143283040|SUPERIORITY||Least Squares Mean Difference|2.3|STANDARD_ERROR_OF_MEAN|0.97||0.019|TWO_SIDED|95.0|0.4|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|0.4|0.019
71882086|NCT02873936|143283040|SUPERIORITY||Least Squares Mean Difference|1.7|STANDARD_ERROR_OF_MEAN|0.97||0.073|TWO_SIDED|95.0|-0.2|3.6||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.6|-0.2|0.073
71882087|NCT02873936|143283040|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.03||0.045|TWO_SIDED|95.0|0.0|4.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.1|0.0|0.045
71882088|NCT02873936|143283040|SUPERIORITY||Least Squares Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|1.02||0.32|TWO_SIDED|95.0|-1.0|3.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||3.0|-1.0|0.32
71882089|NCT02873936|143283040|SUPERIORITY||Least Squares Mean Difference|1.9|STANDARD_ERROR_OF_MEAN|1.19||0.12|TWO_SIDED|95.0|-0.5|4.2||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.2|-0.5|0.12
71882090|NCT02873936|143283040|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.2||0.96|TWO_SIDED|95.0|-2.3|2.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||2.4|-2.3|0.96
71882091|NCT02873936|143283042|SUPERIORITY||Least Squares Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED|95.0|1.6|5.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.7|1.6|<0.001
71882092|NCT02873936|143283042|SUPERIORITY||Least Squares Mean Difference|3.3|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED|95.0|1.2|5.4||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||5.4|1.2|0.002
71882093|NCT02873936|143283042|SUPERIORITY||Least Squares Mean Difference|4.6|STANDARD_ERROR_OF_MEAN|1.28|<|0.001|TWO_SIDED|95.0|2.1|7.1||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||7.1|2.1|<0.001
71922534|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.304|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.304
71922535|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Cochran-Mantel-Haenszel|||Week 10: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.552
71922536|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.494|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.494
71688509|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|0.88||||0.586|TWO_SIDED|95.0|0.54|1.41|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=150 cells/mcgL||1.41|0.54|0.586
71921415|NCT01453439|143363930|SUPERIORITY|||||||0.04||||||Degrees of freedom=91.4|Mixed Models Analysis|||"We compared the change in Quality of life satisfaction over time (During treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Quality of life satisfaction severity in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.04
71921416|NCT01453439|143363930|SUPERIORITY|||||||0.82||||||Degrees of freedom=74.7|Mixed Models Analysis|||"We compared the change in the quality of life satisfaction over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in the quality of life satisfaction in the CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.82
71921417|NCT01453439|143363931|SUPERIORITY||Mean Difference (Net)|0.7937|STANDARD_ERROR_OF_MEAN|0.3007||0.0095|TWO_SIDED|||||Effect of interest: Treatment main effect, two-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment: F(num df=1, den df=112) = 5.17|Least Squares Means difference|Null hypothesis: There is no significant different in the perceived credibility of CBT and SPT.||||0.0095
71921418|NCT01453439|143363935|SUPERIORITY|||||||0.3||||||Degrees of freedom=88.0|Mixed Models Analysis|||"We compared the change in social functioning over time (During Treatment phase) by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts, and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning in the CBT group will not be significantly different from the SPT group \[to be tested\]."||||.30
71921419|NCT01453439|143363935|SUPERIORITY|||||||0.85||||||Degrees of freedom=74.5|Mixed Models Analysis|||"We compared the change in social functioning over time (during the follow-up phase), by randomized treatment group (CBT vs. SPT) using a latent growth curve model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of improvement in social functioning CBT group will not be significantly different from the SPT group during follow-up \[to be tested\]."||||.85
71921420|NCT01453439|143363936|SUPERIORITY||Mean Difference (Net)|1.5867|STANDARD_ERROR_OF_MEAN|0.6882||0.0235|TWO_SIDED|||||a priori significance level: 2-sided alpha = 0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment type, site, time (repeated)) Effect of interest: main effect of treatment - F(num def=1,den df=79.9) = 15.55|Least Squares Means difference|Null hypothesis: There is no significant difference in treatment satisfaction between patients with BDD assigned to CBT vs. SPT.||||0.0235
71921421|NCT01453439|143363937|SUPERIORITY||Median Difference (Net)|9.439|STANDARD_ERROR_OF_MEAN|3.4259||0.0069|TWO_SIDED|||||a priori significance level: 2-sided alpha=0.05 effect adjusted for site effects, time effects, and interactions|ANOVA|repeated measures 3-way ANOVA (treatment group, site, time (repeated)) effect of interest: main effect of treatment: F(num df=1, den df=110) = 7.59|Least Squares Mean difference|Null hypotheses: There is no significant difference in patient expectancy of improvement between BDD patients assigned to CBT vs. SPT.||||0.0069
71921422|NCT01014442|143363938|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.305||||0.2649|TWO_SIDED|95.0|-0.83|4.25|||Wilcoxon rank sum test|||Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2500|-0.8300|0.2649
71921423|NCT01014442|143363938|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.405||||0.3113|TWO_SIDED|95.0|-10.2|42.78|||Wilcoxon rank sum test|||Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||42.7800|-10.2000|0.3113
71921424|NCT01014442|143363938|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.305||||0.2953|TWO_SIDED|95.0|-0.81|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.8100|0.2953
71921425|NCT01014442|143363939|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.29||||0.1308|TWO_SIDED|95.0|-2.99|0.41|||Wilcoxon rank sum test|||Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4100|-2.9900|0.1308
71921426|NCT01014442|143363939|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-10.845||||0.4886|TWO_SIDED|95.0|-31.5|20.79|||Wilcoxon rank sum test|||Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||20.7900|-31.5000|0.4886
71921427|NCT01014442|143363939|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.2218|TWO_SIDED|95.0|-0.6|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.6000|0.2218
71921428|NCT01014442|143363940|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.87||||0.0886|TWO_SIDED|95.0|-3.79|0.28|||Wilcoxon rank sum test|||Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-3.7900|0.0886
71921429|NCT01014442|143363940|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-30.76||||0.022|TWO_SIDED|95.0|-54.97|-6.36|||Wilcoxon rank sum test|||Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-6.3600|-54.9700|0.0220
71688510|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|1.36||||0.331|TWO_SIDED|95.0|0.73|2.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.52|0.73|0.331
71688511|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|1.41||||0.311|TWO_SIDED|95.0|0.73|2.71|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<150 cells/mcgL||2.71|0.73|0.311
71688512|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|0.81||||0.414|TWO_SIDED|95.0|0.48|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.35|0.48|0.414
71688513|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|1.26||||0.463|TWO_SIDED|95.0|0.68|2.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||2.36|0.68|0.463
71688514|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.793|TWO_SIDED|95.0|0.67|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.68|0.67|0.793
71688515|NCT01402986|142892809|SUPERIORITY_OR_OTHER||Rate Ratio|0.77||||0.264|TWO_SIDED|95.0|0.49|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||1.22|0.49|0.264
71688516|NCT01402986|142892810|SUPERIORITY_OR_OTHER||Rate Ratio|0.66||||0.245|TWO_SIDED|95.0|0.33|1.32|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.32|0.33|0.245
71688517|NCT01402986|142892810|SUPERIORITY_OR_OTHER||Rate Ratio|0.76||||0.438|TWO_SIDED|95.0|0.37|1.54|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||1.54|0.37|0.438
71688518|NCT01402986|142892810|SUPERIORITY_OR_OTHER||Rate Ratio|1.01||||0.947|TWO_SIDED|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.57|0.66|0.947
71921430|NCT01014442|143363940|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.56||||0.0008|TWO_SIDED|95.0|-1.02|-0.27|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.2700|-1.0200|0.0008
71922537|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.421|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.421
71688519|NCT01402986|142892810|SUPERIORITY_OR_OTHER||Rate Ratio|0.97||||0.916|TWO_SIDED|95.0|0.59|1.59|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.59|0.59|0.916
71688520|NCT01402986|142892811|SUPERIORITY_OR_OTHER||Rate Ratio|0.91||||0.723|TWO_SIDED|95.0|0.52|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.56|0.52|0.723
71688521|NCT01402986|142892811|SUPERIORITY_OR_OTHER||Rate Ratio|1.06||||0.852|TWO_SIDED|95.0|0.6|1.86|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=60%||1.86|0.60|0.852
71688522|NCT01402986|142892811|SUPERIORITY_OR_OTHER||Rate Ratio|0.86||||0.409|TWO_SIDED|95.0|0.6|1.23|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.23|0.60|0.409
71688523|NCT01402986|142892811|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.744|TWO_SIDED|95.0|0.72|1.58|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted \<=80%||1.58|0.72|0.744
71688524|NCT01402986|142892812|SUPERIORITY_OR_OTHER||Rate Ratio|0.94||||0.802|TWO_SIDED|95.0|0.58|1.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.52|0.58|0.802
71688525|NCT01402986|142892812|SUPERIORITY_OR_OTHER||Rate Ratio|0.6||||0.05|TWO_SIDED|95.0|0.36|1.0|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year||1.00|0.36|0.050
71921431|NCT01014442|143363941|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|3.945||||0.0318|TWO_SIDED|95.0|0.25|8.23|||Wilcoxon rank sum test|||Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.2300|0.2500|0.0318
71921432|NCT01014442|143363941|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-7.59||||0.7144|TWO_SIDED|95.0|-51.19|30.7|||Wilcoxon rank sum test|||Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.7000|-51.1900|0.7144
71921433|NCT01014442|143363941|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.27||||0.393|TWO_SIDED|95.0|-0.31|0.88|||Wilcoxon rank sum test|||Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.8800|-0.3100|0.3930
71921434|NCT01014442|143363942|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|17.08||||0.3002|TWO_SIDED|95.0|-16.5|74.32|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||74.3200|-16.5000|0.3002
71921435|NCT01014442|143363943|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-25.24||||0.0334|TWO_SIDED|95.0|-53.25|-2.29|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.2900|-53.2500|0.0334
71921436|NCT01014442|143363944|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-23.805||||0.1151|TWO_SIDED|95.0|-52.27|5.97|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.9700|-52.2700|0.1151
71921437|NCT01014442|143363945|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-15.63||||0.5974|TWO_SIDED|95.0|-63.88|30.56|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.5600|-63.8800|0.5974
71921438|NCT01014442|143363946|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0005||||0.5466|TWO_SIDED|95.0|-0.00103|0.00259|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00259|-0.00103|0.5466
71921439|NCT01014442|143363946|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00728||||0.3223|TWO_SIDED|95.0|-0.00707|0.03161|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.03161|-0.00707|0.3223
71922538|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.418|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.418
71922539|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.235|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.235
71922540|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.268|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.268
71922541|NCT00883896|143365392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.957|||||||Cochran-Mantel-Haenszel|||Week 12: P-value was assessed from 2-sided stratified CMH row mean test by anti-TNF prior use and geographic region of the site.||||0.957
71922542|NCT01856920|143365412|EQUIVALENCE|Alpha= 0.05||||||0.376|||||||Rank-Sum|||||||0.3760
71922543|NCT04051320|143365429|SUPERIORITY||F statistic|2.164||||0.16|TWO_SIDED||||||repeated measures ANOVA|||||||0.160
71922544|NCT04051320|143365430|SUPERIORITY||F statistic|1.74||||0.1922|TWO_SIDED||||||ANOVA|||||||0.1922
71922545|NCT04051320|143365431|SUPERIORITY||F statistic|0.837||||0.368|TWO_SIDED||||||ANOVA|||||||0.368
71922546|NCT04051320|143365432|SUPERIORITY||F statistic|0.23||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
71922547|NCT04051320|143365433|SUPERIORITY||F statistic|16.541||||0.000723|TWO_SIDED||||||ANOVA|||||||0.000723
71922548|NCT04051320|143365434|SUPERIORITY||F statistic|0.072||||0.791|TWO_SIDED||||||ANOVA|||||||0.791
71922549|NCT04051320|143365435|SUPERIORITY||F statistic|4.952||||0.0372|TWO_SIDED||||||ANOVA|||||||0.0372
71922550|NCT04051320|143365436|SUPERIORITY||F statistic|3.258||||0.0861|TWO_SIDED||||||ANOVA|||||||0.0861
71922551|NCT04051320|143365437|SUPERIORITY||F statistic|2.37||||0.139|TWO_SIDED||||||ANOVA|||||||0.139
71922552|NCT04051320|143365438|SUPERIORITY||F statistic|1.484||||0.237|TWO_SIDED||||||ANOVA|||||||0.237
71922553|NCT04051320|143365439|SUPERIORITY||F statistic|0.013||||0.91|TWO_SIDED||||||ANOVA|||||||0.910
71922554|NCT04051320|143365440|SUPERIORITY||F statistic|4.609||||0.0449|TWO_SIDED||||||ANOVA|||||||0.0449
71922555|NCT04051320|143365441|SUPERIORITY|||||||0.322|||||||Pearson's Correlation Coefficient|||||||0.322
71922556|NCT04051320|143365441|SUPERIORITY|||||||0.772|||||||Pearson's Correlation Coefficient|||||||0.772
71922557|NCT04051320|143365442|SUPERIORITY||Pearson's r|-0.568314||||0.068|TWO_SIDED||||||Pearson correlation|||||||0.068
71922558|NCT04051320|143365442|SUPERIORITY||Pearson's r|-0.082904||||0.8759289|TWO_SIDED||||||Pearson correlation|||||||0.8759289
71922559|NCT04051320|143365443|SUPERIORITY||Pearson's r|-0.1275539||||0.70859639|TWO_SIDED||||||Pearson correlation|||||||0.70859639
71922560|NCT04051320|143365443|SUPERIORITY||Pearson's r|0.49225646||||0.2617744|TWO_SIDED||||||Pearson correlation|||||||0.2617744
71922561|NCT04051320|143365444|SUPERIORITY|||||||0.568|||||||Pearson's Correlation Coefficient|||||||0.568
71922562|NCT04051320|143365444|SUPERIORITY|||||||0.944|||||||Pearson's Correlation Coefficient|||||||0.944
71921440|NCT01014442|143363946|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00026||||0.2108|TWO_SIDED|95.0|-0.0007|0.00012|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00012|-0.00070|0.2108
71921441|NCT01014442|143363946|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000112||||0.4334|TWO_SIDED|95.0|-0.000014|0.0000462|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator.||0.0000462|-0.0000140|0.4334
71922563|NCT04051320|143365445|SUPERIORITY|||||||0.103|||||||Pearson's Correlation Coefficient|||||||0.103
71922564|NCT01632345|143365446|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|6.7|||||TWO_SIDED|95.0|-9.0|22.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||22.4|-9.0|
71922565|NCT01632345|143365446|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|9.7|||||TWO_SIDED|95.0|-4.6|24.9|||||A negative value would be considered as favoring doravirine over efavirenz.|||24.9|-4.6|
71922566|NCT01632345|143365446|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-11.9|||||TWO_SIDED|95.0|-27.9|6.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.3|-27.9|
71922567|NCT01632345|143365446|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.0|||||TWO_SIDED|95.0|-14.5|18.4|||||A negative value would be considered as favoring doravirine over efavirenz.|||18.4|-14.5|
71922568|NCT01632345|143365447|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.3|||||TWO_SIDED|95.0|-13.7|8.8|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.8|-13.7|
71922569|NCT01632345|143365447|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|2.2|||||TWO_SIDED|95.0|-9.9|14.7|||||A negative value would be considered as favoring doravirine over efavirenz.|||14.7|-9.9|
71922570|NCT01632345|143365447|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-2.4|||||TWO_SIDED|95.0|-13.8|8.2|||||A negative value would be considered as favoring doravirine over efavirenz.|||8.2|-13.8|
71922571|NCT01632345|143365447|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-4.8|||||TWO_SIDED|95.0|-15.9|4.1|||||A negative value would be considered as favoring doravirine over efavirenz.|||4.1|-15.9|
71922572|NCT01632345|143365448|SUPERIORITY_OR_OTHER||Difference|-10.2|||||TWO_SIDED|95.0|-20.9|0.5|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.5|-20.9|
71922573|NCT01632345|143365449|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.4|-7.8||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.8|-32.4|0.002
71922574|NCT01632345|143365450|SUPERIORITY_OR_OTHER||Difference (Doravirine - Efavirenz)|-20.4||||0.002|TWO_SIDED|95.0|-32.6|-7.5||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.|||-7.5|-32.6|0.002
71922575|NCT01632345|143365451|SUPERIORITY_OR_OTHER||Difference in % response|15.7|||||TWO_SIDED|95.0|-4.1|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-4.1|
71922576|NCT01632345|143365451|SUPERIORITY_OR_OTHER||Difference in % response|10.0|||||TWO_SIDED|95.0|-9.6|29.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||29.1|-9.6|
71922577|NCT01632345|143365451|SUPERIORITY_OR_OTHER||Difference in % response|6.6|||||TWO_SIDED|95.0|-13.2|26.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||26.0|-13.2|
71922578|NCT01632345|143365451|SUPERIORITY_OR_OTHER||Difference in % response|15.9|||||TWO_SIDED|95.0|-3.4|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.|||34.4|-3.4|
71922579|NCT01632345|143365452|SUPERIORITY_OR_OTHER||Difference in % response|-0.5|||||TWO_SIDED|95.0|-13.2|11.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.2|-13.2|
71922580|NCT01632345|143365453|SUPERIORITY_OR_OTHER||Difference in % response|-1.9|||||TWO_SIDED|95.0|-12.9|9.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.2|-12.9|
71922581|NCT01632345|143365454|SUPERIORITY_OR_OTHER||Difference in % response|-0.8|||||TWO_SIDED|95.0|-12.4|10.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||10.7|-12.4|
71922582|NCT01632345|143365455|SUPERIORITY_OR_OTHER||Difference in % response|4.5|||||TWO_SIDED|95.0|-12.5|21.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||21.5|-12.5|
71922583|NCT01632345|143365455|SUPERIORITY_OR_OTHER||Difference in % response|2.8|||||TWO_SIDED|95.0|-13.9|19.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||19.8|-13.9|
71922584|NCT01632345|143365455|SUPERIORITY_OR_OTHER||Difference in % response|12.2|||||TWO_SIDED|95.0|-2.5|28.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||28.0|-2.5|
71922585|NCT01632345|143365455|SUPERIORITY_OR_OTHER||Difference in % response|9.5|||||TWO_SIDED|95.0|-6.2|25.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||25.7|-6.2|
71922586|NCT01632345|143365456|SUPERIORITY_OR_OTHER||Difference in % response|2.7||||||95.0|-6.1|11.7|||||A positive value would be considered as favoring doravirine over efavirenz.|||11.7|-6.1|
71922587|NCT01632345|143365457|SUPERIORITY_OR_OTHER||Difference in % response|0.1|||||TWO_SIDED|95.0|-9.7|9.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||9.9|-9.7|
71922588|NCT01632345|143365458|SUPERIORITY_OR_OTHER||Difference in % response|3.9|||||TWO_SIDED|95.0|-7.3|15.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||15.0|-7.3|
71922589|NCT01632345|143365459|SUPERIORITY_OR_OTHER||Difference in CD4 change|33.0|||||TWO_SIDED|95.0|-28.1|94.0|||||A positive value would be considered as favoring doravirine over efavirenz.|||94.0|-28.1|
71922590|NCT01632345|143365459|SUPERIORITY_OR_OTHER||Difference in CD4 change|-8.3|||||TWO_SIDED|95.0|-68.5|51.9|||||A positive value would be considered as favoring doravirine over efavirenz.|||51.9|-68.5|
71921442|NCT01014442|143363947|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00081||||0.1511|TWO_SIDED|95.0|-0.00216|0.0003|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00030|-0.00216|0.1511
71921443|NCT01014442|143363947|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00695||||0.4131|TWO_SIDED|95.0|-0.0205|0.01103|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01103|-0.02050|0.4131
71921444|NCT01014442|143363947|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00017||||0.2677|TWO_SIDED|95.0|-0.00046|0.00013|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00046|0.2677
71921445|NCT01014442|143363947|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000185||||0.0173|TWO_SIDED|95.0|-0.0000394|-0.000005|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000050|-0.0000394|0.0173
71921446|NCT01014442|143363948|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00063||||0.3784|TWO_SIDED|95.0|-0.0023|0.00084|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00084|-0.00230|0.3784
71921447|NCT01014442|143363948|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.01602||||0.0942|TWO_SIDED|95.0|-0.03229|0.00297|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00297|-0.03229|0.0942
71921448|NCT01014442|143363948|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00037||||0.0032|TWO_SIDED|95.0|-0.00062|-0.00015|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00015|-0.00062|0.0032
71921449|NCT01014442|143363948|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000126||||0.176|TWO_SIDED|95.0|-0.0000328|-0.0000091|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0000091|-0.0000328|0.1760
71921450|NCT01014442|143363949|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0043||||0.0509|TWO_SIDED|95.0|-0.00027|0.00833|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00833|-0.00027|0.0509
71921451|NCT01014442|143363949|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00567||||0.8262|TWO_SIDED|95.0|-0.03414|0.02671|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.02671|-0.03414|0.8262
71921452|NCT01014442|143363949|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00023||||0.4345|TWO_SIDED|95.0|-0.0003|0.0007|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00070|-0.00030|0.4345
71921453|NCT01014442|143363949|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.6472|TWO_SIDED|95.0|-0.0000586|0.0000364|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000364|-0.0000586|0.6472
71921454|NCT01014442|143363950|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.5745|TWO_SIDED|95.0|-1.95|0.5|||Wilcoxon rank sum test|||Tmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-1.9500|0.5745
71921455|NCT01014442|143363950|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8||||0.2003|TWO_SIDED|95.0|-2.3333|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.3333|0.2003
71921456|NCT01014442|143363950|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.5||||0.0929|TWO_SIDED|95.0|-2.0833|0.0|||Wilcoxon rank sum test|||Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.0833|0.0929
71921457|NCT01014442|143363950|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.0823|TWO_SIDED|95.0|0.0|0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0667|0.0000|0.0823
71922591|NCT01632345|143365459|SUPERIORITY_OR_OTHER||Difference in CD4 change|12.5|||||TWO_SIDED|95.0|-44.6|69.5|||||A positive value would be considered as favoring doravirine over efavirenz.|||69.5|-44.6|
71921458|NCT01014442|143363951|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0417||||0.8106|TWO_SIDED|95.0|-0.5|1.7333|||Wilcoxon rank sum test|||Tmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.7333|-0.5000|0.8106
71921459|NCT01014442|143363951|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-0.1667|0.1667|||Wilcoxon rank sum test|||Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1667|-0.1667|1.0000
71921460|NCT01014442|143363951|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0667||||0.6311|TWO_SIDED|95.0|-0.3333|1.4667|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.4667|-0.3333|0.6311
71921461|NCT01014442|143363951|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.433|TWO_SIDED|95.0|-0.1667|0.0167|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0167|-0.1667|0.4330
71921462|NCT01014442|143363952|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||1|TWO_SIDED|95.0|-1.1667|0.5833|||Wilcoxon rank sum test|||Tmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5833|-1.1667|1.0000
71921463|NCT01014442|143363952|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0833||||0.4947|TWO_SIDED|95.0|-2.0|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0833|-2.0000|0.4947
71921464|NCT01014442|143363952|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1667||||0.4425|TWO_SIDED|95.0|-1.9667|0.2|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2000|-1.9667|0.4425
71921465|NCT01014442|143363952|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0||||0.972|TWO_SIDED|95.0|-0.05|0.0333|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0333|-0.0500|0.9720
71921466|NCT01014442|143363953|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0333||||0.8834|TWO_SIDED|95.0|-1.1667|0.7|||Wilcoxon rank sum test|||Tmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.7000|-1.1667|0.8834
71921467|NCT01014442|143363953|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.8333||||0.0386|TWO_SIDED|95.0|-2.2|0.0|||Wilcoxon rank sum test|||Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.2000|0.0386
71921468|NCT01014442|143363953|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.525||||0.0558|TWO_SIDED|95.0|-2.6167|0.0|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000|-2.6167|0.0558
71921469|NCT01014442|143363953|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.15||||0.0082|TWO_SIDED|95.0|-0.2333|-0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0667|-0.2333|0.0082
71921470|NCT01014442|143363954|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.13||||0.5224|TWO_SIDED|95.0|-0.26|0.5|||Wilcoxon rank sum test|||Cmin of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.5000|-0.2600|0.5224
71921471|NCT01014442|143363954|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|11.16||||0.2088|TWO_SIDED|95.0|-5.29|30.29|||Wilcoxon rank sum test|||Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||30.2900|-5.2900|0.2088
71921472|NCT01014442|143363954|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.165||||0.1794|TWO_SIDED|95.0|-0.45|0.08|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0800|-0.4500|0.1794
71921473|NCT01014442|143363955|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.125||||0.4027|TWO_SIDED|95.0|-0.38|0.19|||Wilcoxon rank sum test|||Cmin of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1900|-0.3800|0.4027
71921474|NCT01014442|143363955|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-16.09||||0.0875|TWO_SIDED|95.0|-29.35|6.39|||Wilcoxon rank sum test|||Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.3900|-29.3500|0.0875
71922592|NCT01632345|143365459|SUPERIORITY_OR_OTHER||Difference in CD4 change|19.6|||||TWO_SIDED|95.0|-45.1|84.2|||||A positive value would be considered as favoring doravirine over efavirenz.|||84.2|-45.1|
71921475|NCT01014442|143363955|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.2||||0.0112|TWO_SIDED|95.0|-0.35|-0.05|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0500|-0.3500|0.0112
71921476|NCT01014442|143363956|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.215||||0.0818|TWO_SIDED|95.0|-0.56|0.05|||Wilcoxon rank sum test|||Cmin of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0500|-0.5600|0.0818
71921477|NCT01014442|143363956|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-14.03||||0.0945|TWO_SIDED|95.0|-26.9|2.94|||Wilcoxon rank sum test|||Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.9400|-26.9000|0.0945
71921478|NCT01014442|143363956|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.19||||0.0081|TWO_SIDED|95.0|-0.41|-0.04|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0400|-0.4100|0.0081
71921479|NCT01014442|143363957|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.36||||0.3289|TWO_SIDED|95.0|-1.14|0.28|||Wilcoxon rank sum test|||Cmin of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2800|-1.1400|0.3289
71921480|NCT01014442|143363957|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-20.3||||0.1243|TWO_SIDED|95.0|-49.39|4.71|||Wilcoxon rank sum test|||Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.7100|-49.3900|0.1243
71921481|NCT01014442|143363957|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.03||||0.8704|TWO_SIDED|95.0|-0.28|0.23|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2300|-0.2800|0.8704
71921482|NCT01014442|143363958|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|5.22||||0.4043|TWO_SIDED|95.0|-5.01|24.49|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||24.4900|-5.0100|0.4043
71921483|NCT01014442|143363959|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.44||||0.893|TWO_SIDED|95.0|-6.07|8.01|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.0100|-6.0700|0.8930
71921484|NCT01014442|143363960|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.935||||0.0819|TWO_SIDED|95.0|-14.31|1.11|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1100|-14.3100|0.0819
71921485|NCT01014442|143363961|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.205||||0.0414|TWO_SIDED|95.0|-19.27|-0.07|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.0700|-19.2700|0.0414
71922593|NCT01632345|143365460|SUPERIORITY_OR_OTHER||Difference in CD4 change|6.3|||||TWO_SIDED|95.0|-38.2|50.8|||||A positive value would be considered as favoring doravirine over efavirenz.|||50.8|-38.2|
71922594|NCT01632345|143365461|SUPERIORITY_OR_OTHER||Difference in CD4 change|-2.6|||||TWO_SIDED|95.0|-46.5|41.3|||||A positive value would be considered as favoring doravirine over efavirenz.|||41.3|-46.5|
71922595|NCT01632345|143365462|SUPERIORITY_OR_OTHER||Difference in CD4 change|-4.4|||||TWO_SIDED|95.0|-64.0|55.1|||||A positive value would be considered as favoring doravirine over efavirenz.|||55.1|-64.0|
71922596|NCT01632345|143365463|SUPERIORITY_OR_OTHER||Difference|-2.8|||||TWO_SIDED|95.0|-11.7|6.0|||||A negative value would be considered as favoring doravirine over efavirenz.|||6.0|-11.7|
71922597|NCT01632345|143365464|SUPERIORITY_OR_OTHER||Difference|-6.5|||||TWO_SIDED|95.0|-14.1|0.3|||||A negative value would be considered as favoring doravirine over efavirenz.|||0.3|-14.1|
71922598|NCT03370133|143365465|SUPERIORITY||Odds Ratio (OR)|99.869|||<|0.001|TWO_SIDED|95.0|34.02|293.175||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||293.175|34.020|<0.001
71922599|NCT03370133|143365465|SUPERIORITY||Odds Ratio (OR)|6.056|||<|0.001|TWO_SIDED|95.0|3.874|9.466||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||9.466|3.874|<0.001
71922600|NCT03370133|143365466|SUPERIORITY||Odds Ratio (OR)|118.762|||<|0.001|TWO_SIDED|95.0|36.701|384.307||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs PBO) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||384.307|36.701|<0.001
71922601|NCT03370133|143365466|SUPERIORITY||Odds Ratio (OR)|4.809|||<|0.001|TWO_SIDED|95.0|3.096|7.47||P-values for the comparison of treatment groups (BKZ 320 mg Q4W vs Ustekinumab) were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio was calculated using stratified CMH (Cochran-Mantel-Haenszel) test with region and prior biologic exposure as stratification variables.||7.470|3.096|<0.001
71688526|NCT01402986|142892812|SUPERIORITY_OR_OTHER||Rate Ratio|0.93||||0.792|TWO_SIDED|95.0|0.56|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||1.56|0.56|0.792
71921486|NCT01014442|143363962|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|69.7186||||0.1552|TWO_SIDED|95.0|-23.4659|162.9545|||Wilcoxon rank sum test|||Vz of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||162.9545|-23.4659|0.1552
71921487|NCT01014442|143363962|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.7836||||0.6057|TWO_SIDED|95.0|-3.2675|2.5529|||Wilcoxon rank sum test|||Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.5529|-3.2675|0.6057
71921488|NCT01014442|143363962|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|299.1021||||0.0188|TWO_SIDED|95.0|79.5869|695.1789|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||695.1789|79.5869|0.0188
71921489|NCT01014442|143363963|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|88.959||||0.0659|TWO_SIDED|95.0|-5.7876|209.0183|||Wilcoxon rank sum test|||Vz of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||209.0183|-5.7876|0.0659
71921490|NCT01014442|143363963|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.4456||||0.7842|TWO_SIDED|95.0|-3.1366|2.292|||Wilcoxon rank sum test|||Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2.2920|-3.1366|0.7842
71921491|NCT01014442|143363963|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|121.3737||||0.4072|TWO_SIDED|95.0|-233.6483|560.0069|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||560.0069|-233.6483|0.4072
71921492|NCT01014442|143363964|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|207.9933||||0.004|TWO_SIDED|95.0|71.2442|355.1739|||Wilcoxon rank sum test|||Vz of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||355.1739|71.2442|0.0040
71921493|NCT01014442|143363964|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|2.6186||||0.0689|TWO_SIDED|95.0|-0.1999|6.7766|||Wilcoxon rank sum test|||Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||6.7766|-0.1999|0.0689
71921494|NCT01014442|143363964|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|635.7812||||0.0306|TWO_SIDED|95.0|49.4696|2793.7642|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||2793.7642|49.4696|0.0306
71921495|NCT01014442|143363965|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|4.7477||||0.9029|TWO_SIDED|95.0|-73.5212|59.8304|||Wilcoxon rank sum test|||Vz of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||59.8304|-73.5212|0.9029
71921496|NCT01014442|143363965|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0077||||0.9692|TWO_SIDED|95.0|-3.6739|3.9521|||Wilcoxon rank sum test|||Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.9521|-3.6739|0.9692
71921497|NCT01014442|143363965|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-149.7962||||0.3744|TWO_SIDED|95.0|-644.4526|311.9735|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||311.9735|-644.4526|0.3744
71921498|NCT01014442|143363966|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|7.8422||||0.1362|TWO_SIDED|95.0|-3.911|18.4444|||Wilcoxon rank sum test|||CL of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||18.4444|-3.9110|0.1362
71921499|NCT01014442|143363966|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1609||||0.4325|TWO_SIDED|95.0|-0.5693|0.271|||Wilcoxon rank sum test|||CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2710|-0.5693|0.4325
71921500|NCT01014442|143363966|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|47.2686||||0.0316|TWO_SIDED|95.0|4.197|112.7806|||Wilcoxon rank sum test|||CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||112.7806|4.1970|0.0316
71688527|NCT01402986|142892812|SUPERIORITY_OR_OTHER||Rate Ratio|1.39||||0.231|TWO_SIDED|95.0|0.81|2.38|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|\> 2 but \< 6 asthma exacerbations in the past year||2.38|0.81|0.231
71921501|NCT01014442|143363967|SUPERIORITY_OR_OTHER||Hodges-Lehmann estmator|19.0536||||0.0572|TWO_SIDED|95.0|-0.425|35.3852|||Wilcoxon rank sum test|||CL of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||35.3852|-0.4250|0.0572
71921502|NCT01014442|143363967|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.3541||||0.3198|TWO_SIDED|95.0|-0.2524|1.1097|||Wilcoxon rank sum test|||CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||1.1097|-0.2524|0.3198
71921503|NCT01014442|143363967|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|54.0322||||0.0845|TWO_SIDED|95.0|-6.7706|160.3469|||Wilcoxon rank sum test|||CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||160.3469|-6.7706|0.0845
71921504|NCT01014442|143363968|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|25.0037||||0.0048|TWO_SIDED|95.0|8.2373|43.5102|||Wilcoxon rank sum test|||CL of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||43.5102|8.2373|0.0048
71921505|NCT01014442|143363968|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.4297||||0.0277|TWO_SIDED|95.0|0.034|0.9925|||Wilcoxon rank sum test|||CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.9925|0.0340|0.0277
71882094|NCT02873936|143283042|SUPERIORITY||Least Squares Mean Difference|2.1|STANDARD_ERROR_OF_MEAN|1.3||0.11|TWO_SIDED|95.0|-0.5|4.7||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||4.7|-0.5|0.11
71882095|NCT02873936|143283045|SUPERIORITY||Least Squares Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|2.5||0.009|TWO_SIDED|95.0|2.0|11.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||11.0|2.0|0.009
71882096|NCT02873936|143283045|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.5||0.003|TWO_SIDED|95.0|3.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|3.0|0.003
71882097|NCT02873936|143283045|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.6||0.003|TWO_SIDED|95.0|3.0|13.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||13.0|3.0|0.003
71882098|NCT02873936|143283045|SUPERIORITY||Least Squares Mean Difference|7.0|STANDARD_ERROR_OF_MEAN|2.6||0.006|TWO_SIDED|95.0|2.0|12.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||12.0|2.0|0.006
71882099|NCT02873936|143283045|SUPERIORITY||Least Squares Mean Difference|9.0|STANDARD_ERROR_OF_MEAN|2.9||0.002|TWO_SIDED|95.0|3.0|15.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||15.0|3.0|0.002
71882100|NCT02873936|143283045|SUPERIORITY||Least Squares Mean Difference|8.0|STANDARD_ERROR_OF_MEAN|2.9||0.007|TWO_SIDED|95.0|2.0|14.0||MMRM model included treatment, visit (as categorical), treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.|MMRM|||Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.||14.0|2.0|0.007
71882101|NCT03099187|143283092|SUPERIORITY||Difference in Group Means|-134.6||||0.6777|TWO_SIDED|95.0|-772.4|503.3||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|t-test, 2 sided|||Primary Analysis in 2019. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||503.3|-772.4|0.6777
71882102|NCT03099187|143283092|SUPERIORITY||Difference in Group Means|-216.0||||0.4682|TWO_SIDED|95.0|-803.6|371.7||p-value was not adjusted for multiplicity and is provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020. Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05||371.7|-803.6|0.4682
71882103|NCT03099187|143283093|SUPERIORITY|||||||0.0383|||||||rank ANCOVA|||Primary Analysis in 2019||||0.0383
71882104|NCT03099187|143283093|SUPERIORITY|||||||0.0239|||||||rank ANCOVA|||Final Analysis in 2020||||0.0239
71882105|NCT03099187|143283094|SUPERIORITY||Overall Mean Difference|95.3||||0.0018|TWO_SIDED|95.0|35.9|154.6||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Primary Analysis in 2019||154.6|35.9|0.0018
71882106|NCT03099187|143283094|SUPERIORITY||Overall Mean Difference|84.3||||0.0096|TWO_SIDED|95.0|20.7|147.8||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Student's t-test|||Final Analysis in 2020||147.8|20.7|0.0096
71882107|NCT03099187|143283095|SUPERIORITY||Odds Ratio (OR)|0.42||||0.0006|TWO_SIDED|95.0|0.25|0.69||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.69|0.25|0.0006
71882108|NCT03099187|143283095|SUPERIORITY||Odds Ratio (OR)|0.43||||0.0009|TWO_SIDED|95.0|0.26|0.71||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.71|0.26|0.0009
71882109|NCT03099187|143283096|SUPERIORITY||Odds Ratio (OR)|0.44||||0.0114|TWO_SIDED|95.0|0.23|0.84||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Primary Analysis in 2019||0.84|0.23|0.0114
71688528|NCT01402986|142892813|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.046|TWO_SIDED|95.0|0.06|0.98|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||0.98|0.06|0.046
71688529|NCT01402986|142892813|SUPERIORITY_OR_OTHER||Rate Ratio|0.47||||0.197|TWO_SIDED|95.0|0.15|1.48|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \>=Median||1.48|0.15|0.197
71688530|NCT01402986|142892813|SUPERIORITY_OR_OTHER||Rate Ratio|1.18||||0.708|TWO_SIDED|95.0|0.5|2.79|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||2.79|0.50|0.708
71882110|NCT03099187|143283096|SUPERIORITY||Odds Ratio (OR)|0.46||||0.0168|TWO_SIDED|95.0|0.24|0.88||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel|||Final Analysis in 2020||0.88|0.24|0.0168
71882111|NCT03099187|143283097|SUPERIORITY|||||||0.0874||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0874
71882112|NCT03099187|143283097|SUPERIORITY|||||||0.1191||||||p-values are not adjusted for multiplicity and are provided for descriptive purpose only.|rank ANCOVA|||Final Analysis in 2020||||0.1191
71882113|NCT03099187|143283098|SUPERIORITY|||||||0.0395||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Primary Analysis in 2019||||0.0395
71882114|NCT03099187|143283098|SUPERIORITY|||||||0.0299||||||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|||Final Analysis in 2020||||0.0299
71882115|NCT03099187|143283099|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.7788|TWO_SIDED|95.0|-5.0|5.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||5.00|-5.00|0.7788
71882116|NCT03099187|143283099|SUPERIORITY||Hodges-Lehmann Median Difference|0.0||||0.8289|TWO_SIDED|95.0|-5.0|5.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate|rank ANCOVA|||Final Analysis in 2020||5.00|-5.00|0.8289
71882117|NCT03099187|143283100|SUPERIORITY||Hodges-Lehmann Median difference|0.29||||0.1872|TWO_SIDED|95.0|-0.45|1.04||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.04|-0.45|0.1872
71882118|NCT03099187|143283100|SUPERIORITY||Hodges-Lehmann Median Difference|0.27||||0.2019|TWO_SIDED|95.0|-0.48|1.02||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.02|-0.48|0.2019
71882119|NCT03099187|143283101|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.2995|TWO_SIDED|95.0|-10.0|4.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||4.00|-10.00|0.2995
71882120|NCT03099187|143283101|SUPERIORITY||Hodges-Lehmann Median Difference|-2.0||||0.3372|TWO_SIDED|95.0|-10.0|4.0||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||4.00|-10.00|0.3372
71882121|NCT03099187|143283102|SUPERIORITY||Hodges-Lehmann Median Difference|-1.86||||0.163|TWO_SIDED|95.0|-5.06|1.38|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.||Primary Analysis in 2019||1.38|-5.06|0.1630
71882122|NCT03099187|143283102|SUPERIORITY||Hodges-Lehmann Median Difference|-1.74||||0.1851|TWO_SIDED|95.0|-5.0|1.55||Analysis of Covariance Changes from baseline to week 24 or early discontinuation visit are compared between the treatment arms using a rank ANCOVA with change from baseline as outcome variable and standardized rank baseline value as covariate.|rank ANCOVA|||Final Analysis in 2020||1.55|-5.00|0.1851
71882123|NCT03099187|143283103|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.5922|TWO_SIDED|95.0|0.59|2.49|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. All-cause non-elective hospitalization.||2.49|0.59|0.5922
71882124|NCT03099187|143283103|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.8057|TWO_SIDED|95.0|0.26|2.83|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Primary Analysis in 2019. Respiratory non-elective hospitalization.||2.83|0.26|0.8057
71882125|NCT03099187|143283103|SUPERIORITY||Hazard Ratio (HR)|1.31||||0.4613|TWO_SIDED|95.0|0.63|2.73|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models|Final Analysis in 2020. All-cause non-elective hospitalization.||2.73|0.63|0.4613
71921506|NCT01014442|143363968|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|318.5455||||0.0002|TWO_SIDED|95.0|154.1902|526.1716|||Wilcoxon rank sum test|||CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||526.1716|154.1902|0.0002
71921507|NCT01014442|143363969|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.579||||0.9417|TWO_SIDED|95.0|-14.5052|11.6346|||Wilcoxon rank sum test|||CL of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||11.6346|-14.5052|0.9417
71921508|NCT01014442|143363969|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1817||||0.2941|TWO_SIDED|95.0|-0.1954|0.6246|||Wilcoxon rank sum test|||CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.6246|-0.1954|0.2941
71921509|NCT01014442|143363969|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.9076||||0.817|TWO_SIDED|95.0|-84.8234|109.9321|||Wilcoxon rank sum test|||CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||109.9321|-84.8234|0.8170
71921510|NCT01014442|143363970|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-2.4102||||0.2798|TWO_SIDED|95.0|-8.5642|3.0044|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.0044|-8.5642|0.2798
71921511|NCT01014442|143363970|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|72.7203||||0.4063|TWO_SIDED|95.0|-107.1596|393.5295|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||393.5295|-107.1596|0.4063
71921512|NCT01014442|143363970|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-3.6042||||0.0441|TWO_SIDED|95.0|-8.1854|-0.1887|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.1887|-8.1854|0.0441
71921513|NCT01014442|143363971|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-5.8077||||0.051|TWO_SIDED|95.0|-11.7302|0.0033|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0033|-11.7302|0.0510
71921514|NCT01014442|143363971|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-171.159||||0.2733|TWO_SIDED|95.0|-361.4437|171.9652|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||171.9652|-361.4437|0.2733
71921515|NCT01014442|143363971|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-1.9621||||0.0718|TWO_SIDED|95.0|-4.8456|0.2067|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.2067|-4.8456|0.0718
71921516|NCT01014442|143363972|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-8.6964||||0.0002|TWO_SIDED|95.0|-13.7713|-4.6498|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-4.6498|-13.7713|0.0002
71921517|NCT01014442|143363972|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-268.9537||||0.0058|TWO_SIDED|95.0|-506.7782|-77.397|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-77.3970|-506.7782|0.0058
71921518|NCT01014442|143363972|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-4.828|||<|0.0001|TWO_SIDED|95.0|-7.1455|-2.6133|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-2.6133|-7.1455|<0.0001
71921519|NCT01014442|143363973|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|1.7477||||0.7144|TWO_SIDED|95.0|-12.101|14.6563|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||14.6563|-12.1010|0.7144
71688531|NCT01402986|142892813|SUPERIORITY_OR_OTHER||Rate Ratio|1.31||||0.594|TWO_SIDED|95.0|0.48|3.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin \< Median||3.57|0.48|0.594
71688532|NCT01402986|142892814|SUPERIORITY_OR_OTHER||Rate Ratio|1.03||||0.975|TWO_SIDED|95.0|0.14|7.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||7.67|0.14|0.975
71688533|NCT01402986|142892814|SUPERIORITY_OR_OTHER||Rate Ratio|1.66||||0.473|TWO_SIDED|95.0|0.41|6.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \>=12%||6.67|0.41|0.473
71688534|NCT01402986|142892814|SUPERIORITY_OR_OTHER||Rate Ratio|0.49||||0.099|TWO_SIDED|95.0|0.21|1.14|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.14|0.21|0.099
71688535|NCT01402986|142892814|SUPERIORITY_OR_OTHER||Rate Ratio|0.42||||0.148|TWO_SIDED|95.0|0.13|1.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility \<12%||1.36|0.13|0.148
71688536|NCT01402986|142892815|SUPERIORITY_OR_OTHER||Rate Ratio|0.82||||0.698|TWO_SIDED|95.0|0.31|2.19|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||2.19|0.31|0.698
71688537|NCT01402986|142892815|SUPERIORITY_OR_OTHER||Rate Ratio|0.55||||0.299|TWO_SIDED|95.0|0.18|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high||1.70|0.18|0.299
71688538|NCT01402986|142892815|SUPERIORITY_OR_OTHER||Rate Ratio|0.25||||0.105|TWO_SIDED|95.0|0.05|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||1.34|0.05|0.105
71921520|NCT01014442|143363973|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-156.3255||||0.3413|TWO_SIDED|95.0|-526.0765|195.8348|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||195.8348|-526.0765|0.3413
71688539|NCT01402986|142892815|SUPERIORITY_OR_OTHER||Rate Ratio|0.7||||0.576|TWO_SIDED|95.0|0.2|2.47|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low||2.47|0.20|0.576
71921521|NCT01014442|143363973|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.888||||0.6251|TWO_SIDED|95.0|-3.0288|4.2273|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||4.2273|-3.0288|0.6251
71921522|NCT01014442|143363974|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|24.315||||0.2342|TWO_SIDED|95.0|-16.0292|79.365|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||79.3650|-16.0292|0.2342
71688540|NCT01402986|142892816|SUPERIORITY_OR_OTHER||Rate Ratio|0.48||||0.133|TWO_SIDED|95.0|0.19|1.25|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.25|0.19|0.133
71688541|NCT01402986|142892816|SUPERIORITY_OR_OTHER||Rate Ratio|0.46||||0.241|TWO_SIDED|95.0|0.13|1.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \>=300 cells/mcgL||1.67|0.13|0.241
71688542|NCT01402986|142892816|SUPERIORITY_OR_OTHER||Rate Ratio|0.59||||0.51|TWO_SIDED|95.0|0.12|2.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.84|0.12|0.510
71688543|NCT01402986|142892816|SUPERIORITY_OR_OTHER||Rate Ratio|0.74||||0.661|TWO_SIDED|95.0|0.19|2.85|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count \<300 cells/mcgL||2.85|0.19|0.661
71688544|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.79||||0.057|TWO_SIDED|95.0|-0.21|13.79|||Repeated measure model|||Baseline serum periostin \>= median||13.79|-0.21|0.057
71688545|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.57||||0.874|TWO_SIDED|95.0|-6.54|7.68|||Repeated measure model|||Baseline serum periostin \>= median||7.68|-6.54|0.874
71688546|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.37||||0.028|TWO_SIDED|95.0|0.8|13.95|||Repeated measure model|||Baseline serum periostin \< median||13.95|0.80|0.028
71688547|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.09||||0.745|TWO_SIDED|95.0|-5.48|7.66|||Repeated measure model|||Baseline serum periostin \< median||7.66|-5.48|0.745
71688548|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.12||||0.011|TWO_SIDED|95.0|1.66|12.58|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||12.58|1.66|0.011
71688549|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.48||||0.863|TWO_SIDED|95.0|-5.93|4.97|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||4.97|-5.93|0.863
71688550|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.24||||0.221|TWO_SIDED|95.0|-3.8|16.27|||Repeated measure model|||Baseline serum periostin \< 25th percentile||16.27|-3.80|0.221
71688551|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.58||||0.108|TWO_SIDED|95.0|-1.91|19.07|||Repeated measure model|||Baseline serum periostin \< 25th percentile||19.07|-1.91|0.108
71688552|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|9.89||||0.09|TWO_SIDED|95.0|-1.57|21.35|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||21.35|-1.57|0.090
71688553|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.7||||0.908|TWO_SIDED|95.0|-11.19|12.59|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||12.59|-11.19|0.908
71688554|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.52||||0.013|TWO_SIDED|95.0|1.41|11.64|||Repeated measure model|||Baseline serum periostin \< 75th percentile||11.64|1.41|0.013
71688555|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.23||||0.635|TWO_SIDED|95.0|-3.84|6.29|||Repeated measure model|||Baseline serum periostin \< 75th percentile||6.29|-3.84|0.635
71882126|NCT03099187|143283103|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.9523|TWO_SIDED|95.0|0.3|3.59|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.|Final Analysis in 2020. Respiratory non-elective hospitalization.||3.59|0.30|0.9523
71882127|NCT03099187|143283105|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.7871|TWO_SIDED|95.0|0.26|2.78|||Log Rank|||||2.78|0.26|0.7871
71688556|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.89||||0.014|TWO_SIDED|95.0|1.84|15.94|||Repeated measure model|||Th2 high||15.94|1.84|0.014
71688557|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.91||||0.28|TWO_SIDED|95.0|-3.19|11.02|||Repeated measure model|||Th2 high||11.02|-3.19|0.280
71688558|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|3.22||||0.292|TWO_SIDED|95.0|-2.78|9.22|||Repeated measure model|||Th2 low||9.22|-2.78|0.292
71688559|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.18||||0.691|TWO_SIDED|95.0|-6.99|4.64|||Repeated measure model|||Th2 low||4.64|-6.99|0.691
71688560|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|8.83||||0.004|TWO_SIDED|95.0|2.85|14.81|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||14.81|2.85|0.004
71688561|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.25||||0.177|TWO_SIDED|95.0|-1.92|10.43|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||10.43|-1.92|0.177
71688562|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.05||||0.159|TWO_SIDED|95.0|-2.39|14.5|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||14.50|-2.39|0.159
71688563|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.72||||0.857|TWO_SIDED|95.0|-8.63|7.18|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||7.18|-8.63|0.857
71688564|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|13.75||||0.002|TWO_SIDED|95.0|5.28|22.22|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||22.22|5.28|0.002
71688565|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|5.23||||0.243|TWO_SIDED|95.0|-3.56|14.02|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||14.02|-3.56|0.243
71688566|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|4.37||||0.144|TWO_SIDED|95.0|-1.5|10.24|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||10.24|-1.50|0.144
71688567|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.804|TWO_SIDED|95.0|-5.01|6.46|||Baseline peripheral blood eosinophil cou|||Baseline peripheral blood eosinophil count \< 300 cells/μ||6.46|-5.01|0.804
71688568|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|11.19||||0.029|TWO_SIDED|95.0|1.15|21.23|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||21.23|1.15|0.029
71688569|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.72||||0.887|TWO_SIDED|95.0|-9.19|10.62|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||10.62|-9.19|0.887
71688570|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.67||||0.002|TWO_SIDED|95.0|2.76|12.59|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||12.59|2.76|0.002
71688571|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.79||||0.268|TWO_SIDED|95.0|-2.15|7.74|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||7.74|-2.15|0.268
71688572|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.82||||0.003|TWO_SIDED|95.0|2.64|13.01|||Repeated measure model|||2 asthma exacerbations in the past year||13.01|2.64|0.003
71688573|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|2.42||||0.361|TWO_SIDED|95.0|-2.78|7.62|||Repeated measure model|||2 asthma exacerbations in the past year||7.62|-2.78|0.361
71688574|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|6.34||||0.185|TWO_SIDED|95.0|-3.06|15.75|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||15.75|-3.06|0.185
71688575|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.986|TWO_SIDED|95.0|-9.5|9.34|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||9.34|-9.50|0.986
71688576|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.87||||0.912|TWO_SIDED|95.0|-14.7|16.44|||Repeated measure model|||Chronic OCS use||16.44|-14.70|0.912
71882128|NCT03099187|143283106|SUPERIORITY||Cox Proportional Hazard|0.84||||0.366|TWO_SIDED|95.0|0.56|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.24|0.56|0.3660
71882129|NCT03099187|143283106|SUPERIORITY||Cox Proportional Hazard|0.85||||0.4173|TWO_SIDED|95.0|0.57|1.26|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.26|0.57|0.4173
71882130|NCT03099187|143283107|SUPERIORITY||Cox Proportional Hazard|0.79||||0.2726|TWO_SIDED|95.0|0.52|1.2|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Primary Analysis in 2019||1.20|0.52|0.2726
71688577|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|-1.46||||0.86|TWO_SIDED|95.0|-17.76|14.84|||Repeated measure model|||Chronic OCS use||14.84|-17.76|0.860
71688578|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|7.56||||0.002|TWO_SIDED|95.0|2.76|12.36|||Repeated measure model|||Without chronic OCS use||12.36|2.76|0.002
71688579|NCT01402986|142892817|SUPERIORITY_OR_OTHER||Difference of LS-mean|1.28||||0.601|TWO_SIDED|95.0|-3.51|6.06|||Repeated measure model|||Without chronic OCS use||6.06|-3.51|0.601
71688580|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.145|TWO_SIDED|95.0|-0.57|0.08|||Repeated measure model|||Baseline serum periostin \>= median||0.08|-0.57|0.145
71688581|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.05||||0.759|TWO_SIDED|95.0|-0.28|0.38|||Repeated measure model|||Baseline serum periostin \>= median||0.38|-0.28|0.759
71688582|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.936|TWO_SIDED|95.0|-0.38|0.35|||Repeated measure model|||Baseline serum periostin \< median||0.35|-0.38|0.936
71688583|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.28||||0.127|TWO_SIDED|95.0|-0.64|0.08|||Repeated measure model|||Baseline serum periostin \< median||0.08|-0.64|0.127
71688584|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.13||||0.343|TWO_SIDED|95.0|-0.41|0.14|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.14|-0.41|0.343
71688585|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.928|TWO_SIDED|95.0|-0.29|0.27|||Repeated measure model|||Baseline serum periostin\>= 25th percentile||0.27|-0.29|0.928
71921523|NCT01014442|143363975|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-13.5592||||0.1964|TWO_SIDED|95.0|-37.395|5.4825|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||5.4825|-37.3950|0.1964
71688586|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.23||||0.374|TWO_SIDED|95.0|-0.74|0.28|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.28|-0.74|0.374
71688587|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.29||||0.259|TWO_SIDED|95.0|-0.81|0.22|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.22|-0.81|0.259
71688588|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.11|-0.84|0.127
71688589|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>= 75th percentile||0.42|-0.56|0.775
71688590|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
71688591|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
71688592|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.24||||0.181|TWO_SIDED|95.0|-0.59|0.11|||Repeated measure model|||Th2 high||0.11|-0.59|0.181
71688593|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.25||||0.161|TWO_SIDED|95.0|-0.6|0.1|||Repeated measure model|||Th2 high||0.10|-0.60|0.161
71688594|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
71688595|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
71688596|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.22||||0.154|TWO_SIDED|95.0|-0.52|0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μL||0.08|-0.52|0.154
71688597|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.271|TWO_SIDED|95.0|-0.48|0.13|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 150 cells/μ||0.13|-0.48|0.271
71688598|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.08||||0.725|TWO_SIDED|95.0|-0.51|0.36|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.36|-0.51|0.725
71688599|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.559|TWO_SIDED|95.0|-0.53|0.28|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.28|-0.53|0.559
71688600|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.47||||0.019|TWO_SIDED|95.0|-0.87|-0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||-0.08|-0.87|0.019
71688601|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.348|TWO_SIDED|95.0|-0.61|0.21|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.21|-0.61|0.348
71688602|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.03||||0.855|TWO_SIDED|95.0|-0.35|0.29|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.29|-0.35|0.855
71688603|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.2||||0.203|TWO_SIDED|95.0|-0.5|0.11|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.11|-0.50|0.203
71688604|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.44||||0.055|TWO_SIDED|95.0|-0.89|0.01|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.01|-0.89|0.055
71688605|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.104|TWO_SIDED|95.0|-0.82|0.08|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.08|-0.82|0.104
71688606|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.652|TWO_SIDED|95.0|-0.37|0.23|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.23|-0.37|0.652
71688607|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.02||||0.905|TWO_SIDED|95.0|-0.28|0.32|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.32|-0.28|0.905
71688608|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.198|TWO_SIDED|95.0|-0.49|0.1|||Repeated measure model|||2 asthma exacerbations in the past year||0.10|-0.49|0.198
71688609|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.18||||0.226|TWO_SIDED|95.0|-0.47|0.11|||Repeated measure model|||2 asthma exacerbations in the past year||0.11|-0.47|0.226
71688610|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.14||||0.513|TWO_SIDED|95.0|-0.56|0.28|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.28|-0.56|0.513
71882131|NCT03099187|143283107|SUPERIORITY||Cox Proportional Hazard|0.82||||0.3386|TWO_SIDED|95.0|0.54|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||Final Analysis in 2020||1.24|0.54|0.3386
71882132|NCT03099187|143283108|SUPERIORITY||Cox Proportional Hazard|1.01||||0.9969|TWO_SIDED|95.0|0.06|16.08|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||16.08|0.06|0.9969
71882133|NCT03099187|143283109|SUPERIORITY|||||||0.3231|||||||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.||||||0.3231
71921524|NCT01014442|143363976|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-22.7878||||0.0672|TWO_SIDED|95.0|-44.8217|3.7573|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||3.7573|-44.8217|0.0672
71921525|NCT01014442|143363977|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-21.4737||||0.2453|TWO_SIDED|95.0|-64.1567|8.5708|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||8.5708|-64.1567|0.2453
71921526|NCT01014442|143363978|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00237||||0.1362|TWO_SIDED|95.0|-0.00734|0.00106|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00106|-0.00734|0.1362
71921527|NCT01014442|143363978|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.04797||||0.4325|TWO_SIDED|95.0|-0.08467|0.26322|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.26322|-0.08467|0.4325
71921528|NCT01014442|143363978|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00311||||0.0316|TWO_SIDED|95.0|-0.00645|-0.00029|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00029|-0.00645|0.0316
71921529|NCT01014442|143363978|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0000158||||0.3269|TWO_SIDED|95.0|-0.0000134|0.0000552|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000552|-0.0000134|0.3269
71921530|NCT01014442|143363979|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00383||||0.0572|TWO_SIDED|95.0|-0.00761|0.0001|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00010|-0.00761|0.0572
71921531|NCT01014442|143363979|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.09626||||0.3198|TWO_SIDED|95.0|-0.25269|0.11464|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.11464|-0.25269|0.3198
71921532|NCT01014442|143363979|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00131||||0.0845|TWO_SIDED|95.0|-0.00352|0.00013|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00013|-0.00352|0.0845
71921533|NCT01014442|143363979|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.00001||||0.1769|TWO_SIDED|95.0|-0.000025|0.0000043|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000043|-0.0000250|0.1769
71921534|NCT01014442|143363980|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0049||||0.0048|TWO_SIDED|95.0|-0.00876|-0.00148|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.00148|-0.00876|0.0048
71921535|NCT01014442|143363980|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.14764||||0.0277|TWO_SIDED|95.0|-0.31026|-0.01067|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||-0.01067|-0.31026|0.0277
71921536|NCT01014442|143363980|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0035||||0.0002|TWO_SIDED|95.0|-0.00476|0.00168|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00168|-0.00476|0.0002
71921537|NCT01014442|143363980|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0000138||||0.1661|TWO_SIDED|95.0|-0.0000295|0.0000047|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000047|-0.0000295|0.1661
71921538|NCT01014442|143363981|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00054||||0.9417|TWO_SIDED|95.0|-0.01037|0.01042|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.01042|-0.01037|0.9417
71921539|NCT01014442|143363981|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.1461||||0.2941|TWO_SIDED|95.0|-0.39951|0.12988|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.12988|-0.39951|0.2941
71921540|NCT01014442|143363981|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.00033||||0.817|TWO_SIDED|95.0|-0.00361|0.00421|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.00421|-0.00361|0.8170
71921541|NCT01014442|143363981|SUPERIORITY_OR_OTHER||Hodge-Lehmann estimator|-0.0000239||||0.1927|TWO_SIDED|95.0|-0.0000594|0.0000154|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0000154|-0.0000594|0.1927
71921542|NCT01014442|143363982|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.1616||||0.0821|TWO_SIDED|95.0|-0.0121|0.4188|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.4188|-0.0121|0.0821
71921543|NCT01014442|143363983|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.0427||||0.3628|TWO_SIDED|95.0|-0.0455|0.1221|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1221|-0.0455|0.3628
71921544|NCT01014442|143363984|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|0.001||||0.9873|TWO_SIDED|95.0|-0.1152|0.1173|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.1173|-0.1152|0.9873
71921545|NCT01014442|143363985|SUPERIORITY_OR_OTHER||Hodges-Lehmann estimator|-0.0857||||0.2178|TWO_SIDED|95.0|-0.187|0.0265|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.||0.0265|-0.1870|0.2178
71921546|NCT01014442|143363991|SUPERIORITY_OR_OTHER||Difference in rates|-1.8||||1|TWO_SIDED|95.0|-24.9|22.1|||Fisher Exact|||||22.1|-24.9|1.0000
71921547|NCT03459794|143364045|OTHER|||||||||||||||||All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =\<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.|||
71921548|NCT03459794|143364046|OTHER|||||||||||||||||All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=\<0.05.|||
71921549|NCT03459794|143364047|OTHER||||||<|0.05|||||||t-test, 1 sided|||||||<0.05
71921550|NCT02177942|143364048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.6931|TWO_SIDED|95.0|-0.2|0.13|||ANCOVA||Difference is test treatment minus control treatment such that a positive difference favours the test treatment.|||0.13|-0.20|0.6931
71921551|NCT01351415|143364057|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.84||||0.1044|TWO_SIDED|90.0|0.71|1.0|||Stratified Log-Rank test|||The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.||1.00|0.71|0.1044
71921552|NCT01351415|143364058|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.83||||0.0573|TWO_SIDED|90.0|0.7|0.98|||Stratified Log-Rank test|||PFS 2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.98|0.70|0.0573
71921553|NCT01351415|143364058|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.63||||0.0045|TWO_SIDED|90.0|0.49|0.83|||Stratified Log-Rank test|||PFS 3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.83|0.49|0.0045
71921554|NCT01351415|143364059|SUPERIORITY_OR_OTHER||Estimated difference in response rate|0.0237||||0.081|TWO_SIDED|90.0|-0.0156|0.063|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0630|-0.0156|0.0810
71921555|NCT01351415|143364060|SUPERIORITY_OR_OTHER||Estimated difference in Disease Control|0.0326||||0.0218|TWO_SIDED|90.0|-0.0288|0.094|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.0940|-0.0288|0.0218
71921556|NCT01351415|143364061|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.29||||0.06|TWO_SIDED|90.0|0.09|0.9|||Stratified Log-Rank test|||The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.90|0.09|0.0600
71921557|NCT01351415|143364063|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.79||||0.0311|TWO_SIDED|90.0|0.65|0.95|||Stratified Log-Rank test|||TTP2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.95|0.65|0.0311
71921558|NCT01351415|143364063|SUPERIORITY_OR_OTHER||Stratified Hazard Ratio|0.69||||0.0326|TWO_SIDED|90.0|0.52|0.92|||Stratified Log-Rank test|||TTP3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.||0.92|0.52|0.0326
71921559|NCT03123549|143364100|SUPERIORITY|||||||0.017|||||||t-test, 1 sided|||||||0.017
71921560|NCT03742271|143364152|SUPERIORITY|Superiority was concluded in the lower limit of the 95% confidence interval was above 0.50.|Proportion|0.974|||||TWO_SIDED|95.0|0.925|0.995|||Binomial Exact Test|||This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.||0.995|0.925|
71921561|NCT01624974|143364159|SUPERIORITY||Difference in Least Squares (LS) Means|0.047||||0.282|TWO_SIDED|95.0|-0.039|0.134|||LDA model|The LDA model assumes that repeated measurements follow a multivariate normal distribution.||||0.134|-0.039|0.282
71921562|NCT01408862|143364168|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||"Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by Wilcoxon-paired test. Variable will be log-transformed if they were not normally distributed. . We used the CSS/ Statistica program package, StatSoft V 6.0.~This analysis applies to both GLP1R and GIPR categories"||||0.04
71921563|NCT01408862|143364169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.2|||||||ANOVA|||Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by two-way ANOVA with repeated measures on one factor, for variables measured in several consecutive times. Variable will be log-transformed if they were not normally distributed. Wilcoxon test for paired samples was used. The Statistica program package (StatSoft V 6.0) were used to perform these analyses, which applied to both GLP1R and GIPR agonist effect categories.||||0.20
71921564|NCT01813149|143364171|SUPERIORITY|||||||0.009|||||||t-test, 2 sided|df=20 t-statistic = 2.90||A t-test to see if expression of α1-AR differs between phenylephrine responders and non-responders||||0.009
71921565|NCT01882439|143364185|SUPERIORITY_OR_OTHER||Risk Difference (RD)|25.95|STANDARD_ERROR_OF_MEAN|5.73|<|0.0001|TWO_SIDED|95.0|14.72|37.19|||Large sample approximation|Missing response (MR) = non-response (NR)||||37.19|14.72|<0.0001
71921566|NCT01882439|143364185|SUPERIORITY_OR_OTHER||Risk Difference (RD)|23.31|STANDARD_ERROR_OF_MEAN|5.71|<|0.0001|TWO_SIDED|95.0|12.1|34.51|||Large sample approximation|MR=NR||||34.51|12.10|<0.0001
71921567|NCT01882439|143364186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2529|STANDARD_ERROR_OF_MEAN|0.06422|<|0.0001|TWO_SIDED|95.0|-0.3792|-0.1266|||Mixed Models Analysis|No imputation||||-0.1266|-0.3792|<0.0001
71921568|NCT01882439|143364186|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.215|STANDARD_ERROR_OF_MEAN|0.06453||0.0009|TWO_SIDED|95.0|-0.3419|-0.0881|||Mixed Models Analysis|No imputation||||-0.0881|-0.3419|0.0009
71921569|NCT03125902|143364224|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2032|TWO_SIDED|95.0|0.6|1.12|||Log Rank|||Stratified Analysis||1.12|0.60|0.2032
71921570|NCT03125902|143364224|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.2601|TWO_SIDED|95.0|0.62|1.14|||Log Rank|||Unstratified Analysis||1.14|0.62|0.2601
71921571|NCT03125902|143364225|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.86||||0.1343|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||||1.05|0.70|0.1343
71921572|NCT03125902|143364225|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.1285|TWO_SIDED|95.0|0.7|1.05|||Log Rank|||Unstratified Analysis||1.05|0.70|0.1285
71921573|NCT03125902|143364226|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5798|TWO_SIDED|95.0|0.76|1.64|||Log Rank|||Stratified Analysis||1.64|0.76|0.5798
71921574|NCT03125902|143364226|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.4035|TWO_SIDED|95.0|0.8|1.72|||Log Rank|||Unstratified Analysis||1.72|0.80|0.4035
71921575|NCT03125902|143364227|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.3425|TWO_SIDED|95.0|0.88|1.43|||Log Rank|||Stratified analysis||1.43|0.88|0.3425
71688611|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.01||||0.974|TWO_SIDED|95.0|-0.43|0.42|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.42|-0.43|0.974
71688612|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.226|TWO_SIDED|95.0|-0.97|0.23|||Repeated measure model|||Chronic OCS use||0.23|-0.97|0.226
71921576|NCT03125902|143364227|SUPERIORITY||Hazard Ratio (HR)|1.16||||0.2166|TWO_SIDED|95.0|0.92|1.48|||Log Rank|||Unstratified Analysis||1.48|0.92|0.2166
71921577|NCT03125902|143364229|OTHER|Stratified analysis|Hazard Ratio (HR)|0.94||||0.6465|TWO_SIDED|95.0|0.71|1.24|||Log Rank|||||1.24|0.71|0.6465
71921578|NCT03125902|143364231|OTHER||Odds Ratio (OR)|1.44||||0.1526|TWO_SIDED|95.0|0.87|2.37|||Cochran-Mantel-Haenszel|||||2.37|0.87|0.1526
71921579|NCT03125902|143364232|OTHER||Odds Ratio (OR)|1.4||||0.1834|TWO_SIDED|95.0|0.85|2.31|||Cochran-Mantel-Haenszel|||||2.31|0.85|0.1834
71921580|NCT03125902|143364233|OTHER||Odds Ratio (OR)|1.42||||0.0513|TWO_SIDED|95.0|1.0|2.02|||Cochran-Mantel-Haenszel|||||2.02|1.00|0.0513
71921581|NCT03125902|143364234|OTHER||Odds Ratio (OR)|1.3||||0.1226|TWO_SIDED|95.0|0.93|1.81|||Cochran-Mantel-Haenszel|||||1.81|0.93|0.1226
71921582|NCT03125902|143364235|OTHER|Unstratified Analysis|Hazard Ratio (HR)|0.74||||0.0641|TWO_SIDED|95.0|0.54|1.02|||Log Rank|||||1.02|0.54|0.0641
71921583|NCT03125902|143364245|SUPERIORITY||Hazard Ratio (HR)|0.62||||0.01227|TWO_SIDED|95.0|0.42|0.9|||Log Rank|||Unstratified Analysis||0.90|0.42|0.01227
71921584|NCT02269709|143364246|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline and Follow-up #1||||<0.0001
71921585|NCT02269709|143364246|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow up #2||||<0.0001
71921586|NCT02269709|143364246|OTHER|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow-up #3||||<0.0001
71921587|NCT02269709|143364247|OTHER|Mean IVC pressures from different time points were compared using the Wilcoxon signed-rank test.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71921588|NCT04411472|143364251|SUPERIORITY||Odds Ratio (OR)|1.18||||0.8025|TWO_SIDED|95.0|0.805|1.732|||One-sided p-value|||||1.732|0.805|0.8025
71921589|NCT04411472|143364252|SUPERIORITY||Odds Ratio (OR)|0.54||||0.1824|TWO_SIDED|95.0|0.139|2.131|||One-sided p-value|||||2.131|0.139|0.1824
71921590|NCT04411472|143364253|SUPERIORITY||Odds Ratio (OR)|0.02||||0.008|TWO_SIDED|95.0|0.001|0.405|||One-sided p-value|||||0.405|0.001|0.0080
71921591|NCT04411472|143364254|SUPERIORITY||Odds Ratio (OR)|0.94||||0.3894|TWO_SIDED|95.0|0.606|1.454|||One-sided p-value|||||1.454|0.606|0.3894
71921592|NCT04411472|143364255|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1237|TWO_SIDED|95.0|0.128|1.697|||One-sided p-value|||||1.697|0.128|0.1237
71921593|NCT04411472|143364257|SUPERIORITY||z-score statistic difference proportions|-7.9||||0.019|TWO_SIDED|95.0|-15.4|-0.4||one-sided p-value based on the z-score statistic for the difference in proportions|one-sided p-value|||||-0.4|-15.4|0.019
71921594|NCT04411472|143364258|SUPERIORITY|||||||0.546|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through to Day 28||||0.5460
71921595|NCT04411472|143364258|SUPERIORITY|||||||0.677|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.6770
71921596|NCT04411472|143364258|SUPERIORITY|||||||0.993|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.9930
71688613|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.15||||0.613|TWO_SIDED|95.0|-0.44|0.75|||Repeated measure model|||Chronic OCS use||0.75|-0.44|0.613
71688614|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.17||||0.198|TWO_SIDED|95.0|-0.43|0.09|||Repeated measure model|||Without chronic OCS use||0.09|-0.43|0.198
71688615|NCT01402986|142892818|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.19||||0.165|TWO_SIDED|95.0|-0.45|0.08|||Repeated measure model|||Without chronic OCS use||0.08|-0.45|0.165
71688616|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.211|TWO_SIDED|95.0|-0.13|0.6|||Repeated measure model|||Baseline serum periostin \>= median||0.60|-0.13|0.211
71688617|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.397|TWO_SIDED|95.0|-0.21|0.53|||Repeated measure model|||Baseline serum periostin \>= median||0.53|-0.21|0.397
71688618|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.315|TWO_SIDED|95.0|-0.18|0.56|||Repeated Measure Model|||Baseline serum periostin \< median||0.56|-0.18|0.315
71688619|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.26||||0.166|TWO_SIDED|95.0|-0.11|0.63|||Repeated measure model|||Baseline serum periostin \< median||0.63|-0.11|0.166
71921597|NCT04411472|143364258|SUPERIORITY|||||||0.779|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.7790
71921598|NCT04411472|143364259|SUPERIORITY|||||||0.051|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||0.0510
71921599|NCT04411472|143364259|SUPERIORITY|||||||0.013|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.0130
71921600|NCT04411472|143364259|SUPERIORITY|||||||0.025|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.0250
71921601|NCT04411472|143364259|SUPERIORITY|||||||0.073|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0730
71921602|NCT04411472|143364260|SUPERIORITY|||||||1|||||||One-sided p-value from re-randomization|||Days alive and free of organ support through Day 28||||1.0000
71921603|NCT04411472|143364260|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||Number of days free of MV||||0.9790
71921604|NCT04411472|143364260|SUPERIORITY|||||||0.675|||||||One-sided p-value from re-randomization|||Number of days free of RRT||||0.6750
71921605|NCT04411472|143364260|SUPERIORITY|||||||0.031|||||||One-sided p-value from re-randomization|||Number of days free of vasopressors and inotropes||||0.0310
71921606|NCT04411472|143364261|SUPERIORITY|||||||0.545|||||||One-sided p-value from re-randomization|||||||0.5450
71921607|NCT04411472|143364262|SUPERIORITY|||||||0.081|||||||One-sided p-value from re-randomization|||||||0.0810
71921608|NCT04411472|143364263|SUPERIORITY|||||||0.979|||||||One-sided p-value from re-randomization|||||||0.9790
71921609|NCT04411472|143364264|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6916|TWO_SIDED|95.0|0.806|1.437|||One-sided p-value|||||1.437|0.806|0.6916
71921610|NCT04411472|143364265|SUPERIORITY||Hazard Ratio (HR)|0.47||||0.0628|TWO_SIDED|95.0|0.18|1.234|||One-sided p-value|||||1.234|0.180|0.0628
71921611|NCT04411472|143364266|SUPERIORITY||Hazard Ratio (HR)|0.01|||<|0.0001|TWO_SIDED|95.0|0.001|0.054|||One-sided p-value|||||0.054|0.001|<0.0001
71921612|NCT03512028|143364283|SUPERIORITY||Mean Difference (Net)|3.2||||0.002|TWO_SIDED|||||Interaction effect of group x time from pre- to post- intervention|ANOVA||Estimated difference between slopes|Mixed model ANOVA with group (RLIC, Sham) and time (pre-, post-, and follow-up ). The main analysis of interest is the group x time interaction from pre- to post-.||||0.002
71921613|NCT03512028|143364283|SUPERIORITY|||||||0.001||||||Main effect of time|ANOVA|||||||0.001
71921614|NCT03512028|143364283|SUPERIORITY|||||||0.844||||||Main effect of group|ANOVA|||||||0.844
71921615|NCT01906489|143364307|SUPERIORITY||Odds Ratio (OR)|11.4739|||=|0.0001|TWO_SIDED|95.0|3.3505|39.2931|||Fisher Exact|||||39.2931|3.3505|=0.0001
71921616|NCT01906489|143364308|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71921617|NCT01906489|143364309|OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71921618|NCT01906489|143364311|OTHER||||||=|0.0953|TWO_SIDED||||||Fisher Exact|||||||=0.0953
71921619|NCT01906489|143364312|OTHER||||||=|0.1238|TWO_SIDED||||||Fisher Exact|||||||=0.1238
71921620|NCT01906489|143364313|OTHER||||||<|0.0001|TWO_SIDED||||||Fisher Exact|||||||<0.0001
71921621|NCT01906489|143364314|OTHER||||||=|0.0019|||||||t-test, 2 sided|||Week 2||||=0.0019
71921622|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
71921623|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
71921624|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
71921625|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
71921626|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
71921627|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
71921628|NCT01906489|143364314|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
71921629|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
71921630|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
71921631|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
71921632|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
71921633|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
71921634|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
71921635|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
71921636|NCT01906489|143364316|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
71921637|NCT01906489|143364318|OTHER||||||=|0.0031|||||||t-test, 2 sided|||Week 2||||=0.0031
71921638|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 4||||<0.0001
71921639|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 6||||<0.0001
71921640|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 8||||<0.0001
71921641|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 12||||<0.0001
71921642|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 16||||<0.0001
71921643|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 19||||<0.0001
71921644|NCT01906489|143364318|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 20||||<0.0001
71921645|NCT01906489|143364320|OTHER||||||<|0.0001|||||||t-test, 2 sided|||Week 2||||<0.0001
71921646|NCT01906489|143364320|OTHER||||||=|0.0133|||||||t-test, 2 sided|||Week 4||||=0.0133
71921647|NCT01906489|143364320|OTHER||||||=|0.3053|||||||t-test, 2 sided|||Week 6||||=0.3053
71921648|NCT01906489|143364320|OTHER||||||=|0.1918|||||||t-test, 2 sided|||Week 8||||=0.1918
71921649|NCT01906489|143364320|OTHER||||||=|0.209|||||||t-test, 2 sided|||Week 12||||=0.2090
71921650|NCT01906489|143364320|OTHER||||||=|0.6184|||||||t-test, 2 sided|||Week 16||||=0.6184
71921651|NCT01906489|143364320|OTHER||||||=|0.3604|||||||t-test, 2 sided|||Week 19||||=0.3604
71921652|NCT01906489|143364320|OTHER||||||=|0.4056|||||||t-test, 2 sided|||Week 20||||=0.4056
71921653|NCT01906489|143364326|OTHER||Hazard Ratio (HR)|4.1451|||=|0.0017|TWO_SIDED|95.0|1.5752|10.908|||Log Rank|||||10.9080|1.5752|=0.0017
71921654|NCT01078389|143364354|SUPERIORITY_OR_OTHER|||||||0.472|||||||Ranked Analysis of Covariance (ANCOVA)|Baseline modified Sharp/van der Heijde Erosion Score as a covariate.||Change from Baseline at Month 24||||0.472
71921655|NCT01078389|143364355|SUPERIORITY_OR_OTHER|||||||0.548|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.548
71921656|NCT01078389|143364356|SUPERIORITY_OR_OTHER|||||||0.389|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.||Change from Baseline at Month 24||||0.389
71921657|NCT01078389|143364357|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Ranked ANCOVA|Baseline RAMRIS Synovitis Score as a covariate.||Synovitis: Change from Baseline at Month 24||||<0.001
71921658|NCT01078389|143364357|SUPERIORITY_OR_OTHER|||||||0.634|||||||Ranked ANCOVA|Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.||Erosion(Distal+Proximal): Change from Baseline at Month 24||||0.634
71921659|NCT01078389|143364357|SUPERIORITY_OR_OTHER|||||||0.307|||||||Ranked ANCOVA|Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.||Edema(Distal+Proximal): Change from Baseline at Month 24||||0.307
71921660|NCT01078389|143364358|SUPERIORITY_OR_OTHER|||||||0.122|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score as a covariate.||Change from Baseline at Month 24||||0.122
71921661|NCT02028182|143364366|OTHER||Kappa statistic-Concordance 0.4 mg/cm2|75.0|||||TWO_SIDED|95.0|60.4|94.0||||||||94.0|60.4|
71921662|NCT02028182|143364366|OTHER||Kappa statistic: Concordance 0.20 mg/cm2|65.0|||||TWO_SIDED|95.0|55.6|90.4||||||||90.4|55.6|
71921663|NCT02028182|143364366|OTHER||Kappa statistic: Concordance0.10 mg/cm2|60.0|||||TWO_SIDED|95.0|53.3|88.4||||||||88.4|53.3|
71921664|NCT02551874|143364384|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<0.3%|Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.085||0.118|TWO_SIDED|95.0|-0.3|0.03||Superiority|Mixed Models Analysis|Adjusted for treatment, baseline HbA1c, randomization stratification factor, visit, treatment-by-visit, and baseline HbA1c-by-visit.||||0.03|-0.30|0.118
71921665|NCT02551874|143364385|SUPERIORITY||Mean Difference (Final Values)|-3.64|STANDARD_ERROR_OF_MEAN|0.282|<|0.001|TWO_SIDED|95.0|-4.2|-3.09|||Mixed Models Analysis|Adjusted for treatment, baseline body weight, randomization stratification factor, visit, treatment-by-visit, and baseline body weight-by-visit.||||-3.09|-4.20|<0.001
71921666|NCT02551874|143364386|SUPERIORITY||Odds Ratio (OR)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.62|||Regression, Logistic|Adjusted for baseline HbA1c and randomization stratification factor (background medication of metformin with or without SU).||||0.62|0.30|<0.001
71921667|NCT02551874|143364387|SUPERIORITY||Odds Ratio (OR)|1.8||||0.008|TWO_SIDED|95.0|1.16|2.67|||Regression, Logistic|||||2.67|1.16|0.008
71921668|NCT02551874|143364388|NON_INFERIORITY|Noninferiority was defined by lower bound of 95% CI \>-10%.|Adjusted Percent Difference|-0.4|||||TWO_SIDED|95.0|-7.42|6.54||||||||6.54|-7.42|
71921669|NCT02551874|143364389|NON_INFERIORITY|Noninferiority was defined by upper bound of 95% CI \<12 mg/dL.|Mean Difference (Final Values)|-19.99|STANDARD_ERROR_OF_MEAN|3.55|<|0.0001|TWO_SIDED|95.0|-26.98|-13.0|||Mixed Models Analysis|Adjusted for treatment, baseline measurement, randomization stratification factor, visit, treatment-by-visit, and baseline-by-visit.||||-13.00|-26.98|<0.0001
71921670|NCT01491802|143364410|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.090
71921671|NCT01491802|143364411|SUPERIORITY|||||||0.68|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.680
71921672|NCT01491802|143364412|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.197
71921673|NCT01491802|143364413|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.006
71921674|NCT01491802|143364414|SUPERIORITY|||||||0.044|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.044
71921675|NCT01491802|143364415|SUPERIORITY|||||||0.573|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.573
71921676|NCT01491802|143364416|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.960
71921677|NCT01491802|143364417|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.944
71921678|NCT01491802|143364418|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.||||0.028
71921679|NCT02600715|143364518|EQUIVALENCE|Test for differences in continuous variables.||||||0.94||||||Two-sided alpha of 0.05 was used to determine statistical significance.|Kruskal-Wallis|||||||0.94
71921680|NCT03938857|143364534|OTHER||Slope|-0.1088295|STANDARD_ERROR_OF_MEAN|0.4728041||0.814|TWO_SIDED|95.0|-1.035508|0.8178494|||Mixed Models Analysis||Estimated value represents interaction between treatment and days.|Placebo group compared to combined Dexmedetomidine groups.||0.8178494|-1.035508|0.814
71921681|NCT02577107|143364562|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.314|STANDARD_ERROR_OF_MEAN|4.1613|||TWO_SIDED|95.0|9.618|31.011||||||||31.011|9.618|
71921682|NCT02516605|143364566|OTHER||adjusted fold change from baseline|0.86||||0.293|TWO_SIDED|90.0|0.68|1.09|||ANCOVA|||||1.09|0.68|0.293
71921683|NCT02516605|143364566|OTHER||adjusted fold change from baseline|0.47|||<|0.001|TWO_SIDED|90.0|0.37|0.6|||ANCOVA|||||0.60|0.37|<0.001
71921684|NCT02516605|143364566|OTHER||adjusted fold change from baseline|0.32|||<|0.001|TWO_SIDED|90.0|0.26|0.4|||ANCOVA|||||0.40|0.26|<.001
71921685|NCT02516605|143364566|OTHER||adjusted fold change from baseline|0.36|||<|0.001|TWO_SIDED|90.0|0.27|0.47|||ANCOVA|||||0.47|0.27|<.001
71921686|NCT02516605|143364576|OTHER||Median difference from baseline|1.0||||0.898|TWO_SIDED|90.0|-7.0|6.0|||Wilcoxon rank-sum test|Day 28||||6.0|-7.0|0.898
71921687|NCT02516605|143364576|OTHER||Median difference from baseline|2.0||||0.593|TWO_SIDED|90.0|-4.0|10.0|||Wilcoxon rank-sum test|Day 56||||10.0|-4.0|0.593
71921688|NCT02516605|143364576|OTHER||Median difference from baseline|-3.0||||0.509|TWO_SIDED|90.0|-11.0|4.0|||Wilcoxon rank-sum test|Day 84||||4.0|-11.0|0.509
71921689|NCT02516605|143364576|OTHER||Median difference from baseline|1.5||||0.591|TWO_SIDED|90.0|-5.0|7.0|||Wilcoxon rank-sum test|Day 28||||7.0|-5.0|0.591
71921690|NCT02516605|143364576|OTHER||Median difference from baseline|-2.0||||0.702|TWO_SIDED|90.0|-12.0|4.0|||Wilcoxon rank-sum test|Day 56||||4.0|-12.0|0.702
71921691|NCT02516605|143364576|OTHER||Median difference from baseline|-1.0||||0.838|TWO_SIDED|90.0|-10.0|8.0|||Wilcoxon rank-sum test|Day 84||||8.0|-10.0|0.838
71921692|NCT02516605|143364576|OTHER||Median difference from baseline|4.0||||0.297|TWO_SIDED|90.0|-3.0|8.0|||Wilcoxon rank-sum test|Day 28||||8.0|-3.0|0.297
71921693|NCT02516605|143364576|OTHER||Median difference from baseline|-6.0||||0.236|TWO_SIDED|90.0|-14.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-14.0|0.236
71921694|NCT02516605|143364576|OTHER||Median difference from baseline|-6.5||||0.192|TWO_SIDED|90.0|-15.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-15.0|0.192
71921695|NCT02516605|143364576|OTHER||Median difference from baseline|2.0||||0.605|TWO_SIDED|90.0|-2.0|9.0|||Wilcoxon rank-sum test|Day 28||||9.0|-2.0|0.605
71921696|NCT02516605|143364576|OTHER||Median difference from baseline|-11.0||||0.037|TWO_SIDED|90.0|-21.0|-1.0|||Wilcoxon rank-sum test|Day 56||||-1.0|-21.0|0.037
71921697|NCT02516605|143364576|OTHER||Median difference from baseline|-3.5||||0.397|TWO_SIDED|90.0|-11.0|3.0|||Wilcoxon rank-sum test|Day 84||||3.0|-11.0|0.397
71921698|NCT02516605|143364577|OTHER||Median difference from baseline|1.0||||0.342|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|-1.0|0.342
71921699|NCT02516605|143364577|OTHER||Median difference from baseline|0.0||||0.699|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.699
71921700|NCT02516605|143364577|OTHER||Median difference from baseline|-1.0||||0.377|TWO_SIDED|90.0|-3.0|0.0|||Wilcoxon rank-sum test|Day 84||||0.0|-3.0|0.377
71921701|NCT02516605|143364577|OTHER||Median difference from baseline|1.0||||0.132|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 28||||2.0|0.0|0.132
71921702|NCT02516605|143364577|OTHER||Median difference from baseline|1.0||||0.292|TWO_SIDED|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|0.0|0.292
71921703|NCT02516605|143364577|OTHER||Median difference from baseline|0.0||||0.979|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.979
71921704|NCT02516605|143364577|OTHER||Median difference from baseline|2.0||||0.102|TWO_SIDED|90.0|0.0|4.0|||Wilcoxon rank-sum test|Day 28||||4.0|0.0|0.102
71921705|NCT02516605|143364577|OTHER||Median difference from baseline|0.0||||0.717|TWO_SIDED|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56||||2.0|-1.0|0.717
71921706|NCT02516605|143364577|OTHER||Median difference|0.0||||1|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|1.000
71921707|NCT02516605|143364577|OTHER||Median difference from baseline|2.0||||0.142|TWO_SIDED|90.0|0.0|5.0|||Wilcoxon rank-sum test|Day 28||||5.0|0.0|0.142
71921708|NCT02516605|143364577|OTHER||Median difference from baseline|0.0||||0.975|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon rank-sum test|Day 56||||1.0|-1.0|0.975
71921709|NCT02516605|143364577|OTHER||Median difference from baseline|0.0||||0.602|TWO_SIDED|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84||||1.0|-2.0|0.602
71921710|NCT02516605|143364578|OTHER||Mean difference from baseline|-2.78|STANDARD_ERROR_OF_MEAN|8.436||0.743|TWO_SIDED|90.0|-16.91|11.34|||ANCOVA|Day 7||||11.34|-16.91|0.743
71921711|NCT02516605|143364578|OTHER||Median difference from baseline|-14.07|STANDARD_ERROR_OF_MEAN|8.229||0.093|TWO_SIDED|90.0|-27.85|-0.28|||ANCOVA|Day 14||||-0.28|-27.85|0.093
71921712|NCT02516605|143364578|OTHER||Median difference from baseline|7.78|STANDARD_ERROR_OF_MEAN|8.71||0.376|TWO_SIDED|90.0|-6.81|22.38|||ANCOVA|Day 21||||22.38|-6.81|0.376
71921713|NCT02516605|143364578|OTHER||Median difference from baseline|7.03|STANDARD_ERROR_OF_MEAN|9.187||0.448|TWO_SIDED|90.0|-8.36|22.43|||ANCOVA|Day 28||||22.43|-8.36|0.448
71921714|NCT02516605|143364578|OTHER||Median difference from baseline|-15.25|STANDARD_ERROR_OF_MEAN|7.192||0.039|TWO_SIDED|90.0|-27.3|-3.19|||ANCOVA|Day 56||||-3.19|-27.30|0.039
71921715|NCT02516605|143364578|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.592||0.054|TWO_SIDED|90.0|-31.31|-2.54|||ANCOVA|Day 84||||-2.54|-31.31|0.054
71921716|NCT02516605|143364578|OTHER||Median difference from baseline|11.34|STANDARD_ERROR_OF_MEAN|8.434||0.185|TWO_SIDED|90.0|-2.78|25.46|||ANCOVA|Day 7||||25.46|-2.78|0.185
71921717|NCT02516605|143364578|OTHER||Median difference from baseline|7.74|STANDARD_ERROR_OF_MEAN|8.226||0.351|TWO_SIDED|90.0|-6.05|21.52|||ANCOVA|Day 14||||21.52|-6.05|0.351
71921718|NCT02516605|143364578|OTHER||Median difference from baseline|16.79|STANDARD_ERROR_OF_MEAN|8.707||0.059|TWO_SIDED|90.0|2.2|31.38|||ANCOVA|day 21||||31.38|2.20|0.059
71921719|NCT02516605|143364578|OTHER||Median difference from baseline|14.05|STANDARD_ERROR_OF_MEAN|9.184||0.132|TWO_SIDED|90.0|-1.35|29.44|||ANCOVA|Day 28||||29.44|-1.35|0.132
71921720|NCT02516605|143364578|OTHER||Median difference from baseline|-1.75|STANDARD_ERROR_OF_MEAN|7.19||0.809|TWO_SIDED|90.0|-13.8|10.31|||ANCOVA|Day 56||||10.31|-13.80|0.809
71921721|NCT02516605|143364578|OTHER||Median difference from baseline|-10.9|STANDARD_ERROR_OF_MEAN|8.59||0.21|TWO_SIDED|90.0|-25.29|3.48|||ANCOVA|Day 84||||3.48|-25.29|0.210
71921722|NCT02516605|143364578|OTHER||Median difference from baseline|13.92|STANDARD_ERROR_OF_MEAN|7.963||0.086||90.0|0.58|27.25|||ANCOVA|day 7||||27.25|0.58|0.086
71921723|NCT02516605|143364578|OTHER||Median difference from baseline|0.48|STANDARD_ERROR_OF_MEAN|7.787||0.951|TWO_SIDED|90.0|-12.57|13.53|||ANCOVA|Day 14||||13.53|-12.57|0.951
71921724|NCT02516605|143364578|OTHER||Median difference from baseline|5.02|STANDARD_ERROR_OF_MEAN|8.244||0.545|TWO_SIDED|90.0|-8.79|18.83|||ANCOVA|day 21||||18.83|-8.79|0.545
71921725|NCT02516605|143364578|OTHER||Median difference from baseline|0.19|STANDARD_ERROR_OF_MEAN|8.697||0.982|TWO_SIDED|90.0|-14.38|14.77|||ANCOVA|Day 28||||14.77|-14.38|0.982
71921726|NCT02516605|143364578|OTHER||Median difference from baseline|-13.82|STANDARD_ERROR_OF_MEAN|6.797||0.047|TWO_SIDED|90.0|-25.21|-2.43|||ANCOVA|day 56||||-2.43|-25.21|0.047
71921727|NCT02516605|143364578|OTHER||Median difference from baseline|-18.23|STANDARD_ERROR_OF_MEAN|8.11||0.029|TWO_SIDED|90.0|-31.81|-4.64|||ANCOVA|Day 84||||-4.64|-31.81|0.029
71921728|NCT02516605|143364578|OTHER||Median difference from baseline|26.7|STANDARD_ERROR_OF_MEAN|8.799||0.004|TWO_SIDED|90.0|11.97|41.44|||ANCOVA|Day 7||||41.44|11.97|0.004
71921729|NCT02516605|143364578|OTHER||Median difference from baseline|8.17|STANDARD_ERROR_OF_MEAN|9.032||0.37|TWO_SIDED|90.0|-6.96|23.29|||ANCOVA|Day 14||||23.29|-6.96|0.370
71921730|NCT02516605|143364578|OTHER||Median difference from baseline|5.9|STANDARD_ERROR_OF_MEAN|10.014||0.558|TWO_SIDED|90.0|-10.86|22.66|||ANCOVA|Day 21||||22.66|-10.86|0.558
71921731|NCT02516605|143364578|OTHER||Median difference from baseline|8.91|STANDARD_ERROR_OF_MEAN|10.911||0.418|TWO_SIDED|90.0|-9.34|27.15|||ANCOVA|Day 28||||27.15|-9.34|0.418
71921732|NCT02516605|143364578|OTHER||Median difference from baseline|-11.08|STANDARD_ERROR_OF_MEAN|7.69||0.156|TWO_SIDED|90.0|-23.95|1.8|||ANCOVA|Day 56||||1.80|-23.95|0.156
71921733|NCT02516605|143364578|OTHER||Median difference from baseline|-16.93|STANDARD_ERROR_OF_MEAN|8.961||0.064|TWO_SIDED|90.0|-31.94|-1.92|||ANCOVA|Day 84||||-1.92|-31.94|0.064
71921734|NCT02839330|143364583|EQUIVALENCE|Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|1.01|||||TWO_SIDED|95.0|0.9|1.13||||||aH5N1c Lot #1 vs. aH5N1c Lot #2||1.13|0.90|
71921735|NCT02839330|143364583|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.96|||||TWO_SIDED|95.0|0.86|1.08||||||aH5N1c Lot #2 vs. aH5N1c Lot #3||1.08|0.86|
71921736|NCT02839330|143364583|EQUIVALENCE|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.97|||||TWO_SIDED|95.0|0.87|1.09||||||aH5N1c Lot #1 vs. aH5N1c Lot #3||1.09|0.87|
71921737|NCT02615158|143364595|EQUIVALENCE|If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.|Slope|0.07|STANDARD_ERROR_OF_MEAN|0.12||0.555|TWO_SIDED|95.0|-0.17|0.31||The alpha for statistical significance is set at 0.05.|Mixed Models Analysis||This is to compare change in maternal lifestyle group to child safety group.|H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.||0.31|-0.17|0.555
71921738|NCT02615158|143364595|EQUIVALENCE|95% CI|Slope|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2|TWO_SIDED|95.0|-0.08|0.39||Two-side test|Mixed Models Analysis||This is to compare the Responsive Parenting to the safety intervention group.|||0.39|-0.08|0.200
71921739|NCT02615158|143364596|EQUIVALENCE|95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.|Slope|-0.11|STANDARD_ERROR_OF_MEAN|0.32||0.739|TWO_SIDED|95.0|-0.74|0.52||The alpha for statistical significance is set at 0.05|Mixed Models Analysis||This is to compare maternal lifestyle to child safety group.|H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.||0.52|-0.74|0.739
71921740|NCT02615158|143364596|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.32||0.904|TWO_SIDED|95.0|-0.66|0.59||The alpha for statistical significance was set at 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to the child safety group.|H0: There are no differences in the change over time between responsive parenting and child safety groups.||0.59|-0.66|0.904
71921741|NCT02615158|143364597|EQUIVALENCE|The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.|Slope|3.31|STANDARD_ERROR_OF_MEAN|2.4||0.168|TWO_SIDED|95.0|-1.4|8.02||Alpha is set at 0.05.|Mixed Models Analysis|||H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.||8.02|-1.4|0.168
71921742|NCT02615158|143364597|EQUIVALENCE|95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.|Slope|0.82|STANDARD_ERROR_OF_MEAN|2.39||0.733|TWO_SIDED|95.0|-3.88|5.52|||Mixed Models Analysis||This is to compare the responsive feeding group to child safety group.|H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time||5.52|-3.88|0.733
71921743|NCT02615158|143364598|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.|Slope|3.3|STANDARD_ERROR_OF_MEAN|2.49||0.186|TWO_SIDED|95.0|-1.6|8.2||Alpha is set at 0.05.|Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.||8.2|-1.6|0.186
71921744|NCT02615158|143364598|EQUIVALENCE|95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.|Slope|-0.03|STANDARD_ERROR_OF_MEAN|2.51||0.99|TWO_SIDED|95.0|-4.97|4.91||Alpha is set to 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|H0 is there is no difference in the change of maternal HEI score over time between the two groups.||4.91|-4.97|0.990
71688620|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.262||95.0|-0.13|0.47|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.47|-0.13|0.262
71688621|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.14||||0.379|TWO_SIDED|95.0|-0.17|0.44|||Repeated measure model|||Baseline serum periostin \>= 25th percentile||0.44|-0.17|0.379
71688622|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.25||||0.387|TWO_SIDED|95.0|-0.32|0.81|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.81|-0.32|0.387
71688623|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.303|TWO_SIDED|95.0|-0.26|0.84|||Repeated measure model|||Baseline serum periostin \< 25th percentile||0.84|-0.26|0.303
71688624|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.37||||0.127|TWO_SIDED|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.11|-0.84|0.127
71688625|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.775|TWO_SIDED|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin \>=75th percentile||0.42|-0.56|0.775
71688626|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.1||||0.512|TWO_SIDED|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.19|-0.38|0.512
71688627|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.12||||0.404|TWO_SIDED|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin \< 75th percentile||0.16|-0.40|0.404
71882134|NCT02831673|143283230|NON_INFERIORITY|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 greater than -10%.|Adjusted difference in proportion|-2.6|||||TWO_SIDED|95.0|-6.7|1.5|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=versus \[vs.\]\>100,000 c/mL) and cluster of differentiation 4+ (CD4+) cell count (\<= vs. \>200 cells per cubic millimeter).|||1.5|-6.7|
71882135|NCT02831673|143283231|OTHER||Adjusted difference in proportion|-0.4|||||TWO_SIDED|95.0|-4.2|3.4|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<=vs.\>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells per cubic millimeter).|||3.4|-4.2|
71688628|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.102|TWO_SIDED|95.0|-0.06|0.69|||Repeated measure model|||Th2 high||0.69|-0.06|0.102
71688629|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.3||||0.116|TWO_SIDED|95.0|-0.08|0.68|||Repeated measure model|||Th2 high||0.68|-0.08|0.116
71688630|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.11||||0.54|TWO_SIDED|95.0|-0.47|0.25|||Repeated measure model|||Th2 low||0.25|-0.47|0.540
71688631|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.07||||0.674|TWO_SIDED|95.0|-0.42|0.27|||Repeated measure model|||Th2 low||0.27|-0.42|0.674
71688632|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.295|TWO_SIDED|95.0|-0.15|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.15|0.295
71688633|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.16||||0.342|TWO_SIDED|95.0|-0.17|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count \>=150 cells/μL||0.49|-0.17|0.342
71688634|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.18||||0.406|TWO_SIDED|95.0|-0.24|0.6|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.60|-0.24|0.406
71688635|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.38||||0.069|TWO_SIDED|95.0|-0.03|0.79|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 150 cells/μL||0.79|-0.03|0.069
71688636|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.19||||0.371|TWO_SIDED|95.0|-0.23|0.62|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.62|-0.23|0.371
71688637|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.07||||0.766|TWO_SIDED|95.0|-0.37|0.51|||Repeated measure model|||Baseline peripheral blood eosinophil count \>= 300 cells/μL||0.51|-0.37|0.766
71688638|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.147|TWO_SIDED|95.0|-0.09|0.57|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.57|-0.09|0.147
71688639|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.35||||0.031|TWO_SIDED|95.0|0.03|0.68|||Repeated measure model|||Baseline peripheral blood eosinophil count \< 300 cells/μL||0.68|0.03|0.031
71688640|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.59||||0.02|TWO_SIDED|95.0|0.1|1.09|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||1.09|0.10|0.020
71688641|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.29||||0.226|TWO_SIDED|95.0|-0.18|0.77|||Repeated measure model|||Baseline FEV1 reversibility \>= 12%||0.77|-0.18|0.226
71688642|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.01||||0.964|TWO_SIDED|95.0|-0.31|0.33|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.33|-0.31|0.964
71688643|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.533|TWO_SIDED|95.0|-0.22|0.42|||Repeated measure model|||Baseline FEV1 reversibility \< 12%||0.42|-0.22|0.533
71688644|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.17||||0.292|TWO_SIDED|95.0|-0.15|0.5|||Repeated measure model|||2 asthma exacerbations in the past year||0.50|-0.15|0.292
71688645|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.27||||0.097|TWO_SIDED|95.0|-0.05|0.59|||Repeated measure model|||2 asthma exacerbations in the past year||0.59|-0.05|0.097
71688646|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.24||||0.26|TWO_SIDED|95.0|-0.18|0.67|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.67|-0.18|0.260
71688647|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.1||||0.648|TWO_SIDED|95.0|-0.33|0.53|||Repeated measure model|||\> 2 but \< 6 asthma exacerbations in the past year||0.53|-0.33|0.648
71688648|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.28||||0.398|TWO_SIDED|95.0|-0.37|0.93|||Repeated measure model|||Chronic OCS use||0.93|-0.37|0.398
71688649|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|-0.32||||0.327|TWO_SIDED|95.0|-0.95|0.32|||Repeated measure model|||Chronic OCS use||0.32|-0.95|0.327
71882136|NCT02831673|143283232|OTHER||Adjusted difference in proportion|-4.9|||||TWO_SIDED|95.0|-9.8|0.0|||||Week 96. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||0.0|-9.8|
71921745|NCT02615158|143364599|EQUIVALENCE|A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.|Slope|23.67|STANDARD_ERROR_OF_MEAN|11.03||0.034|TWO_SIDED|95.0|1.88|45.46||Alpha is set at 0.05.|Mixed Models Analysis||This is for maternal lifestyle group compared to safety control group.|Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.||45.46|1.88|0.034
71921746|NCT02615158|143364599|EQUIVALENCE|H0 is that there is no difference between the change of MVPA over time between the two groups.|Slope|13.52|STANDARD_ERROR_OF_MEAN|10.89||0.216|TWO_SIDED|95.0|-7.98|35.03|||Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|||35.03|-7.98|0.216
71921747|NCT02615158|143364600|EQUIVALENCE|The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.|Slope|10.97|STANDARD_ERROR_OF_MEAN|4.82||0.024|TWO_SIDED|95.0|1.46|20.48|||Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|H0 is that there is no difference in the change of maternal MVPA over time between the two groups.||20.48|1.46|0.024
71921748|NCT02615158|143364600|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|0.98|STANDARD_ERROR_OF_MEAN|4.94||0.804|TWO_SIDED|95.0|-8.76|10.72|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|H0 is that there is no significant difference in the change of maternal MVPA between the two groups.||10.72|-8.76|0.804
71921749|NCT02615158|143364601|EQUIVALENCE|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.056|TWO_SIDED|95.0|-0.78|0.06||Alpha is set at 0.05 for statistical significance.|Mixed Models Analysis||This is to compare maternal lifestyle group to the child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.06|-0.78|0.056
71688650|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.23||||0.105|TWO_SIDED|95.0|-0.05|0.52|||Repeated measure model|||Without chronic OCS use||0.52|-0.05|0.105
71688651|NCT01402986|142892819|SUPERIORITY_OR_OTHER||Difference of LS-mean|0.31||||0.03|TWO_SIDED|95.0|0.03|0.6|||Repeated measure model|||Without chronic OCS use||0.60|0.03|0.030
71921750|NCT02615158|143364601|EQUIVALENCE|Alpha is set at 0.05 to indicate statistical significance.|Slope|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.896|TWO_SIDED|95.0|-0.39|0.45|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.||0.45|-0.39|0.896
71921751|NCT00724594|143364617|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.||||0.9
71921752|NCT00724594|143364617|OTHER|||||||0.9|||||||t-test, 2 sided|||Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort||||0.9
71921753|NCT00724594|143364618|OTHER|||||||0.9||||||not significant|t-test, 2 sided|||Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline||||0.9
71921754|NCT00724594|143364618|OTHER|||||||0.9|||||||t-test, 2 sided|||Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline||||0.9
71921755|NCT00724594|143364619|OTHER|||||||0.072|||||||t-test, 2 sided|||correcting for gestational age at birth||||0.072
71921756|NCT00724594|143364620|OTHER|||||||0.014|||||||t-test, 2 sided|||||||0.014
71921757|NCT00174460|143364628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.991|STANDARD_ERROR_OF_MEAN|0.1067|<|0.001|TWO_SIDED|95.0|0.773|1.21|||ANCOVA|Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).||Treatment difference||1.210|0.773|<0.001
71921758|NCT00174460|143364629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.415|STANDARD_ERROR_OF_MEAN|0.395|<|0.001|TWO_SIDED|95.0|3.605|5.225|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.225|3.605|<0.001
71921759|NCT00174460|143364629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.884|STANDARD_ERROR_OF_MEAN|0.5327||0.108|TWO_SIDED|95.0|-1.977|0.208|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.208|-1.977|0.108
71921760|NCT00174460|143364630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.074|STANDARD_ERROR_OF_MEAN|0.7089||0.141|TWO_SIDED|95.0|-2.524|0.376|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||0.376|-2.524|0.141
71921761|NCT00174460|143364631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.54|STANDARD_ERROR_OF_MEAN|0.3661|<|0.001|TWO_SIDED|95.0|3.789|5.291|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||5.291|3.789|<0.001
71921762|NCT00174460|143364631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.064|STANDARD_ERROR_OF_MEAN|0.9822|<|0.001|TWO_SIDED|95.0|2.049|6.08|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||6.080|2.049|<0.001
71921763|NCT00174460|143364632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.719|STANDARD_ERROR_OF_MEAN|0.1606|<|0.001|TWO_SIDED|95.0|0.39|1.047|||ANCOVA|Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.||Treatment difference Month 24||1.047|0.390|<0.001
71921764|NCT00174460|143364633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.497|<|0.001|TWO_SIDED|95.0|-3.73|-1.68|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 12||-1.68|-3.73|<0.001
71921765|NCT00174460|143364633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.758||0.537|TWO_SIDED|95.0|-2.04|1.09|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 24||1.09|-2.04|0.537
71882137|NCT02831673|143283233|OTHER||Adjusted difference in proportion|-3.6|||||TWO_SIDED|95.0|-9.4|2.1|||||Week 144. Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (\<= vs. \>100,000 c/mL) and CD4+ cell count (\<= vs. \>200 cells/mm\^3).|||2.1|-9.4|
71882138|NCT02831673|143283234|OTHER||Hazard Ratio (HR)|1.0||||0.658|TWO_SIDED|95.0|0.86|1.16||The generalized Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalized Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.|||1.16|0.86|0.658
71882139|NCT02831673|143283238|OTHER||Mean Difference (Net)|17.1||||0.206|TWO_SIDED|95.0|-9.4|43.6|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||43.6|-9.4|0.206
71882140|NCT02831673|143283238|OTHER||Mean Difference (Net)|4.6||||0.754|TWO_SIDED|95.0|-23.9|33.0|||Mixed Model Repeated Measures (MMRM)||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||33.0|-23.9|0.754
71882141|NCT02831673|143283239|OTHER||Mean Difference (Net)|10.8||||0.5|TWO_SIDED|95.0|-20.7|42.4|||Mixed Model Repeated Measures (MMRM)||Week 96. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||42.4|-20.7|0.500
71882142|NCT02831673|143283240|OTHER||Mean Difference (Net)|-1.4||||0.934|TWO_SIDED|95.0|-34.2|31.5|||Mixed Model Repeated Measures (MMRM)||Week 144.Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.|||31.5|-34.2|0.934
71882143|NCT02831673|143283251|OTHER||Mean Difference (Net)|-0.02||||0.025|TWO_SIDED|95.0|-0.04|0.0|||Mixed Model Repeated Measures||Serum Cystatin C, Week 24|||0.00|-0.04|0.025
71882144|NCT02831673|143283251|OTHER||Mean Difference (Net)|-0.03||||0.001|TWO_SIDED|95.0|-0.05|-0.01|||Mixed Model Repeated Measures||Serum Cystatin C, Week 48|||-0.01|-0.05|0.001
71882145|NCT02831673|143283251|OTHER||Mean Difference (Net)|-0.3||||0.683|TWO_SIDED|95.0|-1.6|1.0|||Mixed Model Repeated Measures||Serum RBP, Week 24|||1.0|-1.6|0.683
71882146|NCT02831673|143283251|OTHER||Mean Difference (Net)|-0.1||||0.93|TWO_SIDED|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Serum RBP, Week 48|||1.2|-1.4|0.930
71882147|NCT02831673|143283252|OTHER||Mean Difference (Net)|-0.02||||0.009|TWO_SIDED|95.0|-0.04|-0.01|||Mixed Model Repeated Measures||Week 96. Serum Cystatin C.|||-0.01|-0.04|0.009
71882148|NCT02831673|143283253|OTHER||Mean Difference (Net)|-0.01||||0.108|TWO_SIDED|95.0|-0.03|0.0|||Mixed Model Repeated Measures||Week 144. Serum Cystatin C.|||-0.00|-0.03|0.108
71882149|NCT02831673|143283256|OTHER||Mean Difference (Net)|2.2||||0.011|TWO_SIDED|95.0|0.5|4.0|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 24|||4.0|0.5|0.011
71882150|NCT02831673|143283256|OTHER||Mean Difference (Net)|2.8|||<|0.001|TWO_SIDED|95.0|1.2|4.5|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 48|||4.5|1.2|<0.001
71882151|NCT02831673|143283256|OTHER||Mean Difference (Net)|3.2|||<|0.001|TWO_SIDED|95.0|1.6|4.8|||Mixed Model Repeated Measures||GFR-creatinine adjusted, Week 24|||4.8|1.6|<0.001
71882152|NCT02831673|143283256|OTHER||Mean Difference (Net)|3.5|||<|0.001|TWO_SIDED|95.0|2.0|5.1|||Mixed Model Repeated Measures||GFR- creatinine adjusted, Week 48|||5.1|2.0|<0.001
71882153|NCT02831673|143283259|OTHER||Mean Difference (Net)|-3.19|||<|0.001|TWO_SIDED|95.0|-4.62|-1.75|||Mixed Model Repeated Measures||Week 24|||-1.75|-4.62|<0.001
71882154|NCT02831673|143283259|OTHER||Mean Difference (Net)|-3.22|||<|0.001|TWO_SIDED|95.0|-4.54|-1.91|||Mixed Model Repeated Measures||Week 48|||-1.91|-4.54|<0.001
71882155|NCT02831673|143283260|OTHER||Mean Difference (Net)|-3.34|||<|0.001|TWO_SIDED|95.0|-4.96|-1.72|||Mixed Model Repeated Measures||Week 96. Serum or Plasma creatinine|||-1.72|-4.96|<0.001
71882156|NCT02831673|143283261|OTHER||Mean Difference (Net)|-2.98|||<|0.001|TWO_SIDED|95.0|-4.57|-1.4|||Mixed Model Repeated Measures||Week 144. Serum or Plasma creatinine|||-1.40|-4.57|<0.001
71882157|NCT02831673|143283262|OTHER||Ratio of geometric means|0.915|||<|0.001|TWO_SIDED|95.0|0.887|0.943|||Mixed Model Repeated Measures||Week 24. Serum B2M|||0.943|0.887|<0.001
71882158|NCT02831673|143283262|OTHER||Ratio of geometric means|0.904|||<|0.001|TWO_SIDED|95.0|0.88|0.929|||Mixed Model Repeated Measures||Week 48. Serum B2M|||0.929|0.880|<0.001
71882159|NCT02831673|143283262|OTHER||Ratio of geometric means|0.656||||0.005|TWO_SIDED|95.0|0.491|0.877|||Mixed Model Repeated Measures||Week 24. Urine B2M|||0.877|0.491|0.005
71882160|NCT02831673|143283262|OTHER||Ratio of geometric means|0.672|||<|0.001|TWO_SIDED|95.0|0.551|0.821|||Mixed Model Repeated Measures||Week 48. Urine B2M|||0.821|0.551|<0.001
71882161|NCT02831673|143283262|OTHER||Ratio of geometric means|0.965||||0.575|TWO_SIDED|95.0|0.853|1.092|||Mixed Model Repeated Measures||Week 24. Urine Albumin/Creatinine|||1.092|0.853|0.575
71882162|NCT02831673|143283262|OTHER||Ratio of geometric means|0.891||||0.051|TWO_SIDED|95.0|0.793|1.001|||Mixed Model Repeated Measures||Week 48. Urine Albumin/Creatinine|||1.001|0.793|0.051
71882163|NCT02831673|143283262|OTHER||Ratio of geometric means|0.64|||<|0.001|TWO_SIDED|95.0|0.493|0.831|||Mixed Model Repeated Measures||Week 24. Urine B2M/Urine Creatinine|||0.831|0.493|<0.001
71921766|NCT00174460|143364634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.405||0.364|TWO_SIDED|95.0|-1.21|0.46|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||0.46|-1.21|0.364
71921767|NCT00174460|143364634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.345||0.506|TWO_SIDED|95.0|-0.94|0.48|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||0.48|-0.94|0.506
71921768|NCT00174460|143364635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|1.188||0.959|TWO_SIDED|95.0|-2.42|2.54|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12||2.54|-2.42|0.959
71921769|NCT00174460|143364635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|1.065||0.919|TWO_SIDED|95.0|-2.11|2.32|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24||2.32|-2.11|0.919
71921770|NCT00174460|143364636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.892|STANDARD_ERROR_OF_MEAN|0.8161||0.336|TWO_SIDED|95.0|-3.158|1.374|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 12||1.374|-3.158|0.336
71921771|NCT00174460|143364636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.717|STANDARD_ERROR_OF_MEAN|0.6027||0.3|TWO_SIDED|95.0|-0.956|2.391|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 24||2.391|-0.956|0.300
71921772|NCT00174460|143364637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.615|STANDARD_ERROR_OF_MEAN|0.6591|<|0.001|TWO_SIDED|95.0|4.266|6.963|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference||6.963|4.266|<0.001
71921773|NCT00174460|143364638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.482|STANDARD_ERROR_OF_MEAN|0.9666||0.653|TWO_SIDED|95.0|-3.558|2.595|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||2.595|-3.558|0.653
71921774|NCT00174460|143364638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.205|STANDARD_ERROR_OF_MEAN|0.8991||0.251|TWO_SIDED|95.0|-3.701|1.292|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.292|-3.701|0.251
71921775|NCT00174460|143364639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|1.1499||0.914|TWO_SIDED|95.0|-3.524|3.795|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.795|-3.524|0.914
71921776|NCT00174460|143364639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.292|STANDARD_ERROR_OF_MEAN|0.4432||0.547|TWO_SIDED|95.0|-0.939|1.522|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||1.522|-0.939|0.547
71921777|NCT00174460|143364640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.31|STANDARD_ERROR_OF_MEAN|0.4542||0.007|TWO_SIDED|95.0|1.049|3.572|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12||3.572|1.049|0.007
71921778|NCT00174460|143364640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.626|STANDARD_ERROR_OF_MEAN|0.6536||0.068|TWO_SIDED|95.0|-0.189|3.44|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24||3.440|-0.189|0.068
71921779|NCT00174460|143364643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.5061||0.331|TWO_SIDED|95.0|-0.846|1.965|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 12||1.965|-0.846|0.331
71921780|NCT00174460|143364643|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.114|STANDARD_ERROR_OF_MEAN|0.4703||0.82|TWO_SIDED|95.0|-1.192|1.42|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 24||1.420|-1.192|0.820
71688652|NCT01402986|142892820|SUPERIORITY_OR_OTHER||Rate Ratio|0.95||||0.803|TWO_SIDED|95.0|0.62|1.44|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.44|0.62|0.803
71688653|NCT01402986|142892820|SUPERIORITY_OR_OTHER||Rate Ratio|0.83||||0.457|TWO_SIDED|95.0|0.52|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma||1.35|0.52|0.457
71688654|NCT01402986|142892820|SUPERIORITY_OR_OTHER||Rate Ratio|0.71||||0.25|TWO_SIDED|95.0|0.4|1.27|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.27|0.40|0.250
71688655|NCT01402986|142892820|SUPERIORITY_OR_OTHER||Rate Ratio|1.07||||0.794|TWO_SIDED|95.0|0.66|1.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma||1.74|0.66|0.794
71688656|NCT01402986|142892821|SUPERIORITY_OR_OTHER||Rate Ratio|1.2||||0.614|TWO_SIDED|95.0|0.59|2.46|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.46|0.59|0.614
71688657|NCT01402986|142892821|SUPERIORITY_OR_OTHER||Rate Ratio|1.29||||0.506|TWO_SIDED|95.0|0.61|2.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use||2.74|0.61|0.506
71688658|NCT01402986|142892821|SUPERIORITY_OR_OTHER||Rate Ratio|0.79||||0.243||95.0|0.53|1.18|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.18|0.53|0.243
71921781|NCT00174460|143364644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.42||0.844|TWO_SIDED|95.0|-0.88|1.05|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 12||1.05|-0.88|0.844
71921782|NCT00174460|143364644|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.329||0.519|TWO_SIDED|95.0|-0.52|0.96|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 24||0.96|-0.52|0.519
71921783|NCT00174460|143364647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.998|STANDARD_ERROR_OF_MEAN|0.1095|<|0.001|TWO_SIDED|95.0|0.778|1.219|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||1.219|0.778|<0.001
71921784|NCT00174460|143364647|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.688|STANDARD_ERROR_OF_MEAN|0.1519|<|0.001|TWO_SIDED|95.0|0.382|0.994|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||0.994|0.382|<0.001
71921785|NCT00174460|143364649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.585|STANDARD_ERROR_OF_MEAN|0.3859|<|0.001|TWO_SIDED|95.0|3.806|5.363|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 12||5.363|3.806|<0.001
71921786|NCT00174460|143364649|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.563|STANDARD_ERROR_OF_MEAN|0.708|<|0.001|TWO_SIDED|95.0|2.134|4.992|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit\*treatment and target height SDS.||Treatment difference Month 24||4.992|2.134|<0.001
71688659|NCT01402986|142892821|SUPERIORITY_OR_OTHER||Rate Ratio|0.87||||0.531|TWO_SIDED|95.0|0.57|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs \>2 but =\<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use||1.34|0.57|0.531
71688660|NCT02634983|142892842|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.11||0.0254|TWO_SIDED|90.0|1.4|8.6|||t-test, 2 sided|||Global Ventilated Lung Volume||8.60|1.40|0.0254
71688661|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.77|STANDARD_ERROR_OF_MEAN|2.15||0.035|TWO_SIDED|90.0|1.11|8.44|||t-test, 2 sided|||Lung, Left Ventilation||8.44|1.11|0.0350
71688662|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.96|STANDARD_ERROR_OF_MEAN|2.86||0.0946|TWO_SIDED|90.0|0.08|9.84|||t-test, 2 sided|||Lung, Left Lower Lobe Ventilation||9.84|0.08|0.0946
71688663|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.97|STANDARD_ERROR_OF_MEAN|2.41||0.0486|TWO_SIDED|90.0|0.87|9.07|||t-test, 2 sided|||Lung, Left Upper Lobe Ventilation||9.07|0.87|0.0486
71688664|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.39|STANDARD_ERROR_OF_MEAN|2.33||0.0286|TWO_SIDED|90.0|1.42|9.35|||t-test, 2 sided|||Lung, Right Ventilation||9.35|1.42|0.0286
71688665|NCT02634983|142892843|NON_INFERIORITY|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|3.27|STANDARD_ERROR_OF_MEAN|2.29||0.165|TWO_SIDED|90.0|-0.63|7.17|||t-test, 2 sided|||Lung, Right Lower Lobe Ventilation||7.17|-0.63|0.1650
71921787|NCT02467504|143364651|OTHER|||||||0.53|||||||Chi-squared|||||||0.530
71921788|NCT02467504|143364652|OTHER|||||||0.315|||||||Chi-squared|||||||0.315
71921789|NCT02467504|143364653|OTHER|||||||0.018|||||||Mixed Models Analysis|||||||0.018
71921790|NCT02467504|143364654|OTHER|||||||0.015|||||||Mixed Models Analysis|||||||0.015
71921791|NCT02467504|143364655|OTHER|Chi||||||0.474|||||||Chi-squared|||||||0.474
71921792|NCT02467504|143364656|OTHER|description of Treg cells in CD4+ T cells||||||0.665|||||||Mixed Models Analysis|||||||0.665
71921793|NCT02467504|143364657|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
71921794|NCT02467504|143364658|OTHER|||||||0.616|||||||Chi-squared|||||||0.616
71921795|NCT02467504|143364659|OTHER|||||||0.2|||||||Chi-squared|||||||0.200
71921796|NCT02467504|143364660|OTHER|||||||0.373|||||||Chi-squared|||||||0.373
71921797|NCT02467504|143364661|OTHER|||||||0.565|||||||Chi-squared|||||||0.565
71921798|NCT02467504|143364662|OTHER|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||||||0.221
71921799|NCT02467504|143364663|OTHER|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||||||0.085
71921800|NCT02467504|143364664|OTHER|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.740
71921801|NCT02467504|143364665|OTHER|||||||0.881|||||||Mixed Models Analysis|||||||0.881
71921802|NCT02467504|143364666|OTHER|||||||0.422|||||||Mixed Models Analysis|||||||0.422
71921803|NCT02467504|143364667|OTHER|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||||||0.055
71921804|NCT02467504|143364668|OTHER|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71921805|NCT02467504|143364669|OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.156
71921806|NCT04047472|143364676|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.16||0.006|TWO_SIDED|90.0|-3.0|0.9|||ANOVA|||||0.9|-3.0|0.006
71921807|NCT04047472|143364677|NON_INFERIORITY|Non-inferiority of brolucizumab to aflibercept with respect to change from baseline in BCVA, considering a margin of 4 letters.|LS mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.11||0.009|TWO_SIDED|90.0|-3.2|0.5|||ANOVA|||||0.5|-3.2|0.009
71921808|NCT04269629|143364751|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACEI) and the group without such treatment. The primary outcome was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.25||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||It was assumed that 24% of the patients would be on β-blockers and/or ACE inhibitors (ACEI). A χ2 test with a two-sided 5% significance level has an 80% power to detect the difference between the group without antihypertensive medication with 6% SR during VIT and the group on β-blockers and/or ACEI with 12.3% SR during VIT (OR = 2.2) when the sample sizes are 631 and 200, respectively. A drop-out rate of 37% was assumed which resulted in a required number of 1,319 patients.||||0.25
71921809|NCT04269629|143364752|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.29||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||0.29
71921810|NCT04269629|143364753|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitor) and the group without such treatment. The secondary outcomes were analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.04||||||The level of significance was set at 0.05. Correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions (p=0.04).|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for correlation of the prevalence of cardiovascular diseases and/or hypertension with the risk for more severe systemic sting reactions.||||0.04
71921811|NCT04269629|143364754|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.|||||<|0.001||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||||||<0.001
71921812|NCT04269629|143364755|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.99||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - bee venom.||||0.99
71921813|NCT04269629|143364755|OTHER|All patients participating in this study belong to one of the following two groups for analysis: the group with antihypertensive treatment (β-blockers or ACE inhibitors) and the group without such treatment. The secondary outcomes was analyzed using logistic linear mixed models with a random intercept. This model type takes into account the clustered structure of the data, i.e., observations clustered in the different participating centers.||||||0.15||||||The level of significance was set at 0.05.|Mixed Models Analysis|Missing at random was assumed, and multiple imputations were conducted with 50 imputations taking into account the cluster design.||Analysis for sIgE levels - vespid venom.||||0.15
71688765|NCT04633291|142892936|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard Male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.58||The threshold for statistical significance was set at 0.05|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.58|-0.50|0.88
71688766|NCT04633291|142892937|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.14||||0.62|TWO_SIDED|95.0|-0.72|0.44||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.44|-0.72|0.62
71761076|NCT02469870|143023656|SUPERIORITY|||||||0.81|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.81
71761077|NCT02469870|143023657|SUPERIORITY|||||||0.404|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.404
71758601|NCT00836693|143019578|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.35|<|0.001|TWO_SIDED|95.0|5.1|18.3||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.3|5.1|<0.001
71761078|NCT02469870|143023658|SUPERIORITY|||||||0.246|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.246
71761079|NCT02469870|143023659|SUPERIORITY|||||||0.007|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.007
71761080|NCT02469870|143023660|SUPERIORITY|||||||0.045|||||||t-test, 2 sided|||Two-sample t-test||||.045
71761081|NCT04717336|143023688|SUPERIORITY||Mean of Paired Differences|0.002||||0.98|TWO_SIDED|95.0|-0.22|0.23|||Paired T-Test|A paired t-test was applied across both periods because this is a cross-over study where each participant serves at their own control.||The aim of this analysis is to test whether there is a statistically significant difference in Pulse Wave Velocity when participants are on sodium chloride vs. placebo, regardless of period.||0.23|-0.22|0.98
71761082|NCT03523988|143023693|SUPERIORITY|||||||0.04||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.04
71758602|NCT00836693|143019579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.0|STANDARD_ERROR_OF_MEAN|4.6|<|0.001|TWO_SIDED|95.0|8.9|27.0||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||27.0|8.9|<0.001
71761083|NCT03523988|143023693|SUPERIORITY|||||||0.63||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.63
71761084|NCT03523988|143023693|SUPERIORITY|||||||0.41||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.41
71883065|NCT00385255|143285394|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.61|||||TWO_SIDED|95.0|-2.22|0.96||||||Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||0.96|-2.22|
71922624|NCT00280059|143365534|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.|Mean Difference (Final Values)|-0.16|||||TWO_SIDED|95.0|-0.24|-0.09|||Gart and Nam: correction of skewness||95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.|Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.||-0.09|-0.24|
71922625|NCT00280059|143365535|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.74||||0.0034|TWO_SIDED|95.0|0.6|0.9||Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.|Regression, Cox|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \> 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||0.90|0.60|0.0034
71922626|NCT00280059|143365536|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.06||||0.8047|TWO_SIDED|95.0|0.65|1.74||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.74|0.65|0.8047
71922627|NCT00280059|143365537|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.19||||0.2537|TWO_SIDED|95.0|0.88|1.6||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.60|0.88|0.2537
71922628|NCT00280059|143365538|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|6.52||||0.0025|TWO_SIDED|95.0|1.93|22.04||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||22.04|1.93|0.0025
71922629|NCT00280059|143365539|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.0744|TWO_SIDED|95.0|0.97|1.91||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.91|0.97|0.0744
71922630|NCT00280059|143365540|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.47||||0.0003|TWO_SIDED|95.0|1.19|1.8||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio \< 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.||1.80|1.19|0.0003
71922631|NCT00280059|143365550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8||||0.0025|TWO_SIDED|95.0|0.3|1.4|||ANCOVA|||Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.4|0.3|0.0025
71922632|NCT00280059|143365550|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6||||0.0186|TWO_SIDED|95.0|0.1|1.1|||ANCOVA|||Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.||1.1|0.1|0.0186
71922633|NCT00280059|143365551|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.0683|TWO_SIDED|95.0|0.98|1.93|||Regression, Logistic|||Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.93|0.98|0.0683
71922634|NCT00280059|143365551|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.5096|TWO_SIDED|95.0|0.78|1.66|||Regression, Logistic|||Week 32: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.66|0.78|0.5096
71922635|NCT00280059|143365551|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.09||||0.6804|TWO_SIDED|95.0|0.73|1.63|||Regression, Logistic|||Week 56 (termination): dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.||1.63|0.73|0.6804
71761085|NCT03523988|143023694|SUPERIORITY|||||||0.65||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.65
71761086|NCT03523988|143023694|SUPERIORITY|||||||0.82||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.82
71883066|NCT00385255|143285394|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.55|||||TWO_SIDED|95.0|-2.52|1.42||||||Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.||1.42|-2.52|
71883067|NCT00385255|143285395|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H1N1 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.37|||||TWO_SIDED|95.0|-2.84|7.58||||||Difference in seroconversion rates for anti-H1N1 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.||7.58|-2.84|
71883068|NCT00385255|143285395|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H3N2 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|5.58|||||TWO_SIDED|95.0|1.1|10.07||||||Difference in seroconversion rates for anti-H3N2 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.||10.07|1.10|
71883069|NCT00385255|143285395|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase anti-B antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.15|||||TWO_SIDED|95.0|-2.9|7.2||||||Difference in seroconversion rates for anti-B antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.||7.20|-2.90|
71883070|NCT02079987|143285422|SUPERIORITY|||||||0.49|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.49
71883071|NCT02079987|143285423|SUPERIORITY|||||||0.23|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.||||||0.23
71883072|NCT02079987|143285424|SUPERIORITY|||||||0.25||||||A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|difference-in-difference analysis|||||||0.25
71883073|NCT02079987|143285425|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
71883074|NCT02079987|143285426|SUPERIORITY|||||||0.57|||||||Chi-squared|||||||0.57
71883075|NCT02079987|143285427|SUPERIORITY|||||||0.87|||||||Chi-squared|||||||0.87
71883076|NCT01445951|143285429|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 0.4 margin|Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.086|||TWO_SIDED|95.0|0.02|0.36||||||MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit\*treatment)||0.36|0.02|
71883077|NCT01445951|143285430|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.016|||TWO_SIDED|95.0|-0.02|0.04|||||Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit\*Treatment)|||0.04|-0.02|
71883078|NCT01445951|143285431|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-35.42|STANDARD_ERROR_OF_MEAN|10.622|||TWO_SIDED|95.0|-56.25|-14.59|||||MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit\*Treatment)|||-14.59|-56.25|
71883079|NCT01445951|143285434|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.512||0.0102|TWO_SIDED|95.0|-2.33|-0.31|||ANCOVA|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|||-0.31|-2.33|0.0102
71883080|NCT01445951|143285434|SUPERIORITY_OR_OTHER|||||||0.4955|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.4955
71883081|NCT01445951|143285434|SUPERIORITY_OR_OTHER|||||||0.6807|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.6807
71883082|NCT01445951|143285434|SUPERIORITY_OR_OTHER|||||||0.0079|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero||||0.0079
71883083|NCT01445951|143285436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5328||||0.0156|TWO_SIDED|95.0|0.3198|0.8877|||Regression, Logistic|Logistic model with affects for Region, Basal insulin stratum, and Treatment||||0.8877|0.3198|0.0156
71883084|NCT01445951|143285437|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||<0.0001
71883085|NCT01445951|143285438|SUPERIORITY_OR_OTHER|||||||0.1022|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time||||||0.1022
71883086|NCT01445951|143285439|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.449||||0.0158|TWO_SIDED|95.0|0.23|0.86|||Regression, Logistic|Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c|Gen2 in the numerator, Aspart in the denominator|||0.86|0.23|0.0158
71883087|NCT02076997|143285440|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71883088|NCT02076997|143285446|OTHER|||||||||||||||||There was no statistical analysis performed for this aim as it was descriptive|There was no statistical analysis performed for this aim as it was descriptive|||
71883089|NCT02076997|143285447|OTHER||Odds Ratio (OR)|6.7|||||TWO_SIDED|95.0||||||||||||
71883090|NCT03817775|143285450|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71883091|NCT03817775|143285451|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71883092|NCT03817775|143285452|OTHER|||||||0.7215|||||||Wilcoxon (Mann-Whitney)|||||||0.7215
71883093|NCT03817775|143285453|OTHER|||||||0.5675|||||||Wilcoxon (Mann-Whitney)|||||||0.5675
71883094|NCT03817775|143285454|OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||||||<0.01
71883095|NCT00401375|143285460|OTHER||Mean Difference (Final Values)|-0.23||||0.4259||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.4259
71883096|NCT00401375|143285460|OTHER||Mean Difference (Final Values)|0.13||||0.3575||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.||||0.3575
71883097|NCT00950664|143285464|NON_INFERIORITY_OR_EQUIVALENCE|81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.||||||0.05||95.0|||||Paired-t test|||||||0.05
71883098|NCT03152019|143285471|SUPERIORITY||percentages|0.77|||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71883099|NCT00350142|143285481|SUPERIORITY_OR_OTHER||proportion|0.75|||||TWO_SIDED|||||||||||||
71883100|NCT00610987|143285491|SUPERIORITY_OR_OTHER||||||=|0.12|TWO_SIDED||||||t-test, 1 sided|||||||=0.12
71883101|NCT00254501|143285492|SUPERIORITY_OR_OTHER|||||||0.0757||||||Adjusted for baseline Hemoglobin A-1C.|ANCOVA|||"Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months."||||0.0757
71883102|NCT00254501|143285493|SUPERIORITY_OR_OTHER|||||||0.44|||||||ANCOVA|||Comparison of change in LDL from baseline to 12 months between groups.||||0.44
71883103|NCT00254501|143285493|SUPERIORITY_OR_OTHER|||||||0.16|||||||ANCOVA|||Comparison of change in HDL from baseline to 12 months between groups.||||0.16
71883104|NCT00254501|143285493|SUPERIORITY_OR_OTHER|||||||0.14|||||||ANCOVA|||Comparison of change in total cholesterol from baseline to 12 months between groups.||||0.14
71883105|NCT00254501|143285493|SUPERIORITY_OR_OTHER|||||||0.92|||||||ANCOVA|||Comparison of change in triglycerides from baseline to 12 months between groups.||||0.92
71883106|NCT00254501|143285494|SUPERIORITY_OR_OTHER|||||||0.3856|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.3856
71883107|NCT00254501|143285494|SUPERIORITY_OR_OTHER|||||||0.6413|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.||||.6413
71883108|NCT00254501|143285494|SUPERIORITY_OR_OTHER|||||||0.4303|||||||Wilcoxon (Mann-Whitney)|||Analyses not adjusted for other variables.||||.4303
71883109|NCT00254501|143285495|SUPERIORITY_OR_OTHER|||||||0.785|||||||ANCOVA|||Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.||||0.785
71883110|NCT00254501|143285495|SUPERIORITY_OR_OTHER|||||||0.302|||||||ANCOVA|||Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.||||0.302
71883111|NCT00254501|143285495|SUPERIORITY_OR_OTHER|||||||0.0024|||||||ANCOVA|||Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.||||0.0024
71883112|NCT01515787|143285531|NON_INFERIORITY|Disease recurrence or death in order to have 85% power to reject the null hypothesis. Noninferiority of the intervention could be claimed if the upper limit of the two-sided 90.2% confidence interval of the hazard ratio for disease recurrence or death did not exceed the 1.29 noninferiority margin.|Hazard Ratio (HR)|0.92||||0.005|TWO_SIDED|90.2|0.74|1.14|||kaplan meier|||||1.14|0.74|0.005
71883113|NCT01515787|143285533|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.74|1.44||||||||1.44|0.74|
71883114|NCT01515787|143285535|SUPERIORITY||Hazard Ratio (HR)|1.18|||||TWO_SIDED|95.0|0.44|3.16||||||||3.16|0.44|
71883115|NCT03776175|143285543|SUPERIORITY||Difference in LS mean|-44.52||||0|TWO_SIDED|90.0|-54.97|-31.65|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in least square (LS) mean between groups||-31.65|-54.97|0.0000
71883116|NCT03776175|143285543|SUPERIORITY||Difference in LS Mean|-35.4||||0.0007|TWO_SIDED|90.0|-47.4|-20.68|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference LS mean between groups.||-20.68|-47.40|0.0007
71883117|NCT03776175|143285543|SUPERIORITY||Difference in LS Mean|-44.64||||0|TWO_SIDED|90.0|-54.8|-32.19|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||-32.19|-54.80|0.0000
71883118|NCT03776175|143285543|SUPERIORITY||Difference in LS Mean|-0.21||||0.9836|TWO_SIDED|90.0|-15.66|18.08|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||18.08|-15.66|0.9836
71883119|NCT03776175|143285543|SUPERIORITY||Difference in LS Mean|-14.3||||0.1233|TWO_SIDED|90.0|-27.32|1.06|||ANCOVA||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 90% CI was calculated on difference in LS mean between groups.||1.06|-27.32|0.1233
71883120|NCT03776175|143285543|SUPERIORITY||Difference in LS Mean|-0.21|||||TWO_SIDED|50.0|-6.82|6.87|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||6.87|-6.82|
71883121|NCT03776175|143285543|SUPERIORITY||Difference in LS Mean|-14.3|||||TWO_SIDED|50.0|-19.86|-8.35|||||LS mean difference was not a simple subtraction between LS means of groups but through statistical model.|Natural log-transformed of individual relative change from baseline to Day 42 was analyzed using the ANCOVA model with treatment as a fixed effect, natural log-transformed baseline whole liver fat by MRI-PDFF as covariate. Values were back-transformed from the log scale. 50% CI was calculated on difference in LS mean between groups.||-8.35|-19.86|
71761087|NCT03523988|143023694|SUPERIORITY|||||||0.69||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.69
71883122|NCT05525533|143285550|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-1.87|2.24|||Regression, Linear|||||2.24|-1.87|
71883123|NCT05525533|143285550|SUPERIORITY||Mean Difference (Final Values)|1.55|||||TWO_SIDED|95.0|-0.73|3.82|||Regression, Linear|||||3.82|-0.73|
71883124|NCT05525533|143285552|SUPERIORITY||Mean Difference (Final Values)|7.58|||||TWO_SIDED|95.0|-2.92|18.0|||Regression, Linear|||||18|-2.92|
71883125|NCT05525533|143285552|SUPERIORITY||Mean Difference (Final Values)|16.0|||||TWO_SIDED|95.0|0.64|31.0|||Regression, Linear|||||31|0.64|
71883126|NCT05525533|143285554|SUPERIORITY||Mean Difference (Final Values)|47.0|||||TWO_SIDED|95.0|-18.0|113.0|||Regression, Linear|||||113|-18|
71883127|NCT05525533|143285554|SUPERIORITY||Mean Difference (Final Values)|113.0|||||TWO_SIDED|95.0|38.0|189.0|||Regression, Linear|||||189|38|
71883128|NCT05525533|143285555|SUPERIORITY||Mean Difference (Final Values)|3.63|||||TWO_SIDED|95.0|-1.37|8.63|||Regression, Linear|||||8.63|-1.37|
71883129|NCT05525533|143285555|SUPERIORITY||Mean Difference (Final Values)|1.5|||||TWO_SIDED|95.0|-1.5|4.5|||Regression, Linear|||||4.50|-1.50|
71883130|NCT05525533|143285556|SUPERIORITY||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-0.36|7.3|||Regression, Linear|||||7.30|-0.36|
71883131|NCT05525533|143285556|SUPERIORITY||Mean Difference (Final Values)|3.38|||||TWO_SIDED|95.0|-0.54|7.3|||Regression, Linear|||||7.30|-0.54|
71883132|NCT05525533|143285557|SUPERIORITY||Mean Difference (Final Values)|0.17|||||TWO_SIDED|95.0|-3.38|3.72|||Regression, Linear|||||3.72|-3.38|
71883133|NCT05525533|143285557|SUPERIORITY||Mean Difference (Final Values)|7.57|||||TWO_SIDED|95.0|0.42|15.0|||Regression, Linear|||||15|0.42|
71922636|NCT00951912|143365583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7981|STANDARD_ERROR_OF_MEAN|2.422|<|0.05|TWO_SIDED|95.0|-6.6569|5.0607|||ANOVA|||"Null hypothesis: There are no difference in the difference of changes in plasma glucose.~Power calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate."||5.0607|-6.6569|<0.05
71922637|NCT00951912|143365583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0842|STANDARD_ERROR_OF_MEAN|2.411|<|0.05|TWO_SIDED|95.0|-2.7486|8.9171|||ANOVA|||||8.9171|-2.7486|<0.05
71922638|NCT00951912|143365583|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.8823|STANDARD_ERROR_OF_MEAN|2.399|<|0.05|TWO_SIDED|95.0|-1.9234|9.6881|||ANOVA|||||9.6881|-1.9234|<0.05
71922639|NCT00951912|143365584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7696|STANDARD_ERROR_OF_MEAN|4.2|<|0.05|TWO_SIDED|95.0|-11.9308|8.3916|||ANOVA|||||8.3916|-11.9308|<0.05
71922640|NCT00951912|143365584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6929|STANDARD_ERROR_OF_MEAN|4.1818|<|0.05|TWO_SIDED|95.0|-9.4232|10.8091|||ANOVA|||||10.8091|-9.4232|<0.05
71922641|NCT00951912|143365584|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.4626|STANDARD_ERROR_OF_MEAN|4.1624|<|0.05|TWO_SIDED|95.0|-7.6067|12.5318|||ANOVA|||||12.5318|-7.6067|<0.05
71922642|NCT00951912|143365585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01174|STANDARD_ERROR_OF_MEAN|1.45967|<|0.05|TWO_SIDED|95.0|-3.5428|3.5194|||ANOVA|||||3.5194|-3.5428|<0.05
71922643|NCT00951912|143365585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.68659|STANDARD_ERROR_OF_MEAN|1.4532|<|0.05|TWO_SIDED|95.0|-6.202|0.8288|||ANOVA|||||0.8288|-6.2020|<0.05
71922644|NCT00951912|143365585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.67485|STANDARD_ERROR_OF_MEAN|1.44646|<|0.05|TWO_SIDED|95.0|-6.174|0.8243|||ANOVA|||||0.8243|-6.174|<0.05
71922645|NCT00951912|143365586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9661|STANDARD_ERROR_OF_MEAN|3.14977|<|0.05|TWO_SIDED|95.0|-10.5857|4.6535|||ANOVA|||||4.6535|-10.5857|<0.05
71922646|NCT00951912|143365586|SUPERIORITY_OR_OTHER||Odds Ratio, log|-0.9972|STANDARD_ERROR_OF_MEAN|3.13581|<|0.05|TWO_SIDED|95.0|-8.583|6.5886|||ANOVA|||||6.5886|-8.5830|<0.05
71922647|NCT00951912|143365586|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.9689|STANDARD_ERROR_OF_MEAN|3.12126|<|0.05|TWO_SIDED|95.0|-5.5817|9.5195|||ANOVA|||||9.5195|-5.5817|<0.05
71922648|NCT00951912|143365587|SUPERIORITY_OR_OTHER||Mean Rank|1.442|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71922649|NCT00951912|143365588|SUPERIORITY_OR_OTHER||Mean Ranks|1.895|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71922650|NCT00951912|143365589|SUPERIORITY_OR_OTHER||Mean Ranks|2.169|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71922651|NCT00951912|143365590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.437|STANDARD_ERROR_OF_MEAN|4.9113|<|0.05|TWO_SIDED|95.0|-8.444|15.318|||ANOVA|||||15.318|-8.444|<0.05
71922652|NCT00951912|143365590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.4809|STANDARD_ERROR_OF_MEAN|4.8896|<|0.05|TWO_SIDED|95.0|-8.3475|15.3092|||ANOVA|||||15.3092|-8.3475|<0.05
71922653|NCT00951912|143365590|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0439|STANDARD_ERROR_OF_MEAN|4.8669|<|0.05|TWO_SIDED|95.0|-11.7296|11.8174|||ANOVA|||||11.8174|-11.7296|<0.05
71922654|NCT00951912|143365591|SUPERIORITY_OR_OTHER||Mean ranks|1.031|||<|0.05|||||||Kruskal-Wallis|||||||<0.05
71922655|NCT00951912|143365592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8185|STANDARD_ERROR_OF_MEAN|3.2343|<|0.05|TWO_SIDED|95.0|-6.0057|9.6426|||ANOVA|||||9.6426|-6.0057|<0.05
71922656|NCT00951912|143365592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0276|STANDARD_ERROR_OF_MEAN|3.2199|<|0.05|TWO_SIDED|95.0|-6.7619|8.817|||ANOVA|||||8.8170|-6.7619|<0.05
71922657|NCT00951912|143365592|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7909|STANDARD_ERROR_OF_MEAN|3.205|<|0.05|TWO_SIDED|95.0|-8.5442|6.9624|||ANOVA|||||6.9624|-8.5442|<0.05
71922658|NCT00951912|143365593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.0122|STANDARD_ERROR_OF_MEAN|4.1686|<|0.05|TWO_SIDED|95.0|-8.0721|12.0964|||ANOVA|||||12.0964|-8.0721|<0.05
71922659|NCT00951912|143365593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7716|STANDARD_ERROR_OF_MEAN|4.1501|<|0.05|TWO_SIDED|95.0|-10.8111|9.2679|||ANOVA|||||9.2679|-10.8111|<0.05
71922660|NCT00951912|143365593|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.7837|STANDARD_ERROR_OF_MEAN|4.1309|<|0.05|TWO_SIDED|95.0|-12.7767|7.2092|||ANOVA|||||7.2092|-12.7767|<0.05
71922661|NCT00951912|143365594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4437|STANDARD_ERROR_OF_MEAN|0.1001|<|0.05|TWO_SIDED|95.0|-0.6416|-0.2458|||ANOVA|||||-0.2458|-0.6416|<0.05
71922662|NCT00951912|143365594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1986|STANDARD_ERROR_OF_MEAN|0.09986|<|0.05|TWO_SIDED|95.0|-0.3956|-0.0016|||ANOVA|||||-0.0016|-0.3956|<0.05
71922663|NCT00951912|143365594|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2451|STANDARD_ERROR_OF_MEAN|0.09648|<|0.05|TWO_SIDED|95.0|0.0544|0.4358|||ANOVA|||||0.4358|0.0544|<0.05
71922664|NCT00951912|143365595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6353|STANDARD_ERROR_OF_MEAN|0.1146|<|0.05|TWO_SIDED|95.0|-0.8617|-0.4089|||ANOVA|||||-0.4089|-0.8617|<0.05
71922665|NCT00951912|143365595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0282|STANDARD_ERROR_OF_MEAN|0.1156||0.05|TWO_SIDED|95.0|-0.2003|0.2568|||ANOVA|||||0.2568|-0.2003|0.05
71922666|NCT00951912|143365595|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6635|STANDARD_ERROR_OF_MEAN|0.1121|<|0.05|TWO_SIDED|95.0|0.4419|0.8851|||ANOVA|||||0.8851|0.4419|<0.05
71922667|NCT00951912|143365596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1557|STANDARD_ERROR_OF_MEAN|0.119|<|0.05||95.0|-0.3911|0.0796|||ANOVA|||||0.0796|-0.3911|<0.05
71922668|NCT00951912|143365596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.606|STANDARD_ERROR_OF_MEAN|0.119||0.05|TWO_SIDED|95.0|-0.8414|-0.3707|||ANOVA|||||-0.3707|-0.8414|0.05
71922669|NCT00951912|143365596|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4503|STANDARD_ERROR_OF_MEAN|0.1163|<|0.05|TWO_SIDED|95.0|-0.6804|-0.2202|||ANOVA|||||-0.2202|-0.6804|<0.05
71922670|NCT00951912|143365597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|102.4|STANDARD_ERROR_OF_MEAN|83.4|<|0.05|TWO_SIDED|95.0|-99.3|304.1|||ANOVA|||||304.1|-99.3|<0.05
71922671|NCT00951912|143365597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.8|STANDARD_ERROR_OF_MEAN|82.6||0.05|TWO_SIDED|95.0|-203.7|196.1|||ANOVA|||||196.1|-203.7|0.05
71922672|NCT00951912|143365597|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-106.2|STANDARD_ERROR_OF_MEAN|82.2|<|0.05|TWO_SIDED|95.0|-305.1|92.8|||ANOVA|||||92.8|-305.1|<0.05
71922673|NCT02612194|143365654|OTHER|Estimation only.|Overall Response Rate|0.0|||||TWO_SIDED|95.0|0.0|0.369|||||Confidence interval estimated using the Clopper Pearson method.|||0.369|0.000|
71883134|NCT05525533|143285558|SUPERIORITY||Mean Difference (Final Values)|2.46|||||TWO_SIDED|95.0|-0.11|5.02|||Regression, Linear|||||5.02|-0.11|
71883135|NCT05525533|143285558|SUPERIORITY||Mean Difference (Final Values)|3.29|||||TWO_SIDED|95.0|0.33|6.25|||Regression, Linear|||||6.25|0.33|
71883136|NCT02429414|143285592|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71883137|NCT02429414|143285593|SUPERIORITY|||||||0.0209|||||||t-test, 2 sided|||||||0.0209
71883138|NCT02429414|143285594|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||||||0.078
71883139|NCT05051904|143285596|OTHER||Adjusted Hazard Ratio|0.5|||<|0.0001|TWO_SIDED|95.0|0.402|0.622|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.622|0.402|<0.0001
71883140|NCT05051904|143285596|OTHER||Adjusted Hazard Ratio|0.784||||0.0004|TWO_SIDED|95.0|0.686|0.896|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Rivaroxaban.|||0.896|0.686|0.0004
71883141|NCT05051904|143285596|OTHER||Adjusted Hazard Ratio|0.637|||<|0.0001|TWO_SIDED|95.0|0.514|0.791|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.791|0.514|<0.0001
71883142|NCT05051904|143285597|OTHER||Adjusted Hazard Ratio|0.78|||<|0.0001|TWO_SIDED|95.0|0.714|0.851|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio \<1 favors Dabigatran.|||0.851|0.714|<0.0001
71883143|NCT05051904|143285597|OTHER||Adjusted Hazard Ratio|0.827|||<|0.0001|TWO_SIDED|95.0|0.777|0.88|||Regression, Cox|Cox proportional hazard model with s-IPTW. 'Treatment' is the only Independent variable used to estimate the hazard ratios.|Hazard ratio\<1 favors Rivaroxaban|||0.88|0.777|<0.0001
71883144|NCT00794677|143285625|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.252|STANDARD_ERROR_OF_MEAN|0.112||0.03||95.0|||||ANOVA|||Statistical significance was determined for a standard two-period crossover design using JMP software (Version 5.0, SAS Institute. Cary, NC).||||0.03
71883145|NCT00794677|143285626|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.273|STANDARD_ERROR_OF_MEAN|0.102||0.01||95.0|||||ANOVA|||||||0.01
71883146|NCT00794677|143285627|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.048|STANDARD_ERROR_OF_MEAN|0.089||0.6||95.0|||||ANOVA|||||||0.60
71883147|NCT00794677|143285628|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.47||0.67||95.0|||||ANOVA|||||||0.67
71883148|NCT00794677|143285629|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.14||0.3||95.0|||||ANOVA|||||||0.30
71883149|NCT00794677|143285630|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.412|STANDARD_ERROR_OF_MEAN|1.569|<|0.0001|TWO_SIDED|95.0|||||ANOVA|||||||<0.0001
71883150|NCT00794677|143285631|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.846|STANDARD_ERROR_OF_MEAN|2.866|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
71883151|NCT00794677|143285632|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.397|STANDARD_ERROR_OF_MEAN|1.893||0.009|TWO_SIDED|95.0|||||ANOVA|||||||0.009
71883152|NCT00794677|143285633|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-21.353|STANDARD_ERROR_OF_MEAN|2.22|<|1e-07|TWO_SIDED|95.0|||||ANOVA|||||||<0.0000001
71883153|NCT03015259|143285634|EQUIVALENCE|To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Referece LS Mean Ratio|1.04|||||TWO_SIDED|90.0|0.958|1.13|||||Fieller's formula was applied|Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.||1.130|0.958|
71883154|NCT03015259|143285635|EQUIVALENCE|To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.|Test/Reference LS Mean Ratio|1.004|||||TWO_SIDED|90.0|0.889|1.14|||||Fieller's formula was applied|Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.||1.140|0.889|
71883155|NCT03015259|143285636|OTHER|||||||||||||||||Comparison of means, no formal statistical comparison|no statistical significance applied|||
71883156|NCT00143312|143285672|SUPERIORITY_OR_OTHER||Crude IFI Rate (percent) at 12 months|7.0||||||95.0|2.0|19.0||||||||19|2|
71883157|NCT00143312|143285672|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 12 months|10.0||||||95.0|2.0|27.0||||||||27|2|
71883158|NCT00143312|143285673|SUPERIORITY_OR_OTHER||IFI Rate (percent) at 6 months|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
71883159|NCT00143312|143285674|SUPERIORITY_OR_OTHER||IFI Rate (percent) at End of Prophylaxis|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||24|2|
71883160|NCT00143312|143285678|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 6 months|79.0||||||95.0|64.0|91.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||91|64|
71883161|NCT00143312|143285678|SUPERIORITY_OR_OTHER||survive free of IFI (percent): 12 months|69.0||||||95.0|52.0|83.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage|||83|52|
71883162|NCT03341962|143285686|SUPERIORITY||Odds Ratio (OR)|1.0188||||0.5836|TWO_SIDED||||||Cochran-Mantel-Haenszel|1-sided exact test adjusted for stratification factors (prior use of any biologics and concurrent use of corticosteroids), α=0.097||||||0.5836
71883163|NCT02500628|143285747|OTHER|||||||0.77|||||||t-test, 2 sided|||comparison between fibromyalgia and non-fibromyalgia group||||0.77
71922674|NCT02612194|143365655|OTHER|Estimation only|Median|3.1|||||TWO_SIDED|95.0|0.2|6.1|||||The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||6.1|0.2|
71922675|NCT02612194|143365656|OTHER|Estimation only|Median|1.5|||||TWO_SIDED|95.0|0.2|1.8|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||1.8|0.2|
71922676|NCT00149227|143365657|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|STANDARD_DEVIATION|2.0|<|0.05|TWO_SIDED|95.0|-0.975|0.975|||Cox's proportional hazard analysis|||"We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.~with a two-tailed 5% statistical signiﬁcant level."||0.975|-0.975|<0.05
71922677|NCT02539160|143365671|SUPERIORITY||Median Difference (Net)|6.4||||0.105|TWO_SIDED|95.0|-1.1|14.3|||t-test, 2 sided|||||14.3|-1.1|0.105
71922678|NCT02539160|143365671|SUPERIORITY||Mean Difference (Final Values)|6.0||||0.112|TWO_SIDED|95.0|-1.5|13.7|||t-test, 2 sided|||||13.7|-1.5|0.112
71922679|NCT02312934|143365702|OTHER||||||=|0.41||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||=0.41
71922680|NCT02312934|143365703|OTHER|||||||0.79||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p \< 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.||||0.79
71922681|NCT02978339|143365704|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||.03
71922682|NCT02978339|143365705|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71922683|NCT02978339|143365706|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||||||0.91
71922684|NCT02978339|143365707|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||||||0.41
71922685|NCT02978339|143365708|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||.15
71922686|NCT02978339|143365709|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||.06
71883164|NCT02500628|143285748|OTHER|||||||0.27|||||||t-test, 2 sided|||||||0.27
71688767|NCT04633291|142892938|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|0.11||||0.63|TWO_SIDED|95.0|-0.36|0.57||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.57|-0.36|0.63
71758603|NCT00836693|143019583|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.2|STANDARD_ERROR_OF_MEAN|3.37|<|0.001|TWO_SIDED|95.0|9.5|22.8||P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||22.8|9.5|<0.001
71883165|NCT02500628|143285749|OTHER|||||||0.92|||||||t-test, 2 sided|||difference between fibromyalgia and non-fibromyalgia patients.||||0.92
71883166|NCT01627860|143285755|SUPERIORITY_OR_OTHER||Difference in Seizure free rate|23.57||||0.0759|TWO_SIDED|95.0|-4.21|49.0|||ANOVA||Difference in Seizure free rate (Monotherapy minus Add on therapy)|||49.00|-4.21|0.0759
71883167|NCT01627860|143285756|SUPERIORITY_OR_OTHER||Difference in mean percent change|18.3||||0.7102|TWO_SIDED|95.0|-81.0|117.7|||ANCOVA||Difference in mean percent change of seizure frequency (Monotherapy minus Add on therapy)|||117.7|-81.0|0.7102
71883168|NCT04770389|143285764|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
71883169|NCT04770389|143285765|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
71883170|NCT04770389|143285766|SUPERIORITY||Least Squares (LS) Mean|-44.92|STANDARD_ERROR_OF_MEAN|5.183|<|0.0001|TWO_SIDED|95.0|-55.2|-34.63|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-34.63|-55.20|<0.0001
71883171|NCT04770389|143285767|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
71922687|NCT02978339|143365710|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||.93
71922688|NCT00689299|143365714|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||ANOVA with baseline score as covariate||||<0.05
71922689|NCT00434876|143365732|SUPERIORITY_OR_OTHER|||||||0.49||95.0|||||Mixed Models Analysis|||||||0.49
71922690|NCT00434876|143365733|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|||||||0.04
71922691|NCT00434876|143365734|SUPERIORITY_OR_OTHER|||||||0.57||95.0|||||Mixed Models Analysis|||||||0.57
71922692|NCT00434876|143365735|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||Mixed Models Analysis|||||||0.03
71922693|NCT00758394|143365736|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.|ANOVA|||The null hypothesis states that there is no difference between groups.||||<0.05
71922694|NCT00784225|143365756|SUPERIORITY||Cox Proportional Hazard|0.75||||0.52|TWO_SIDED|95.0|0.32|1.79|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for selenium||1.79|0.32|0.52
71922695|NCT00784225|143365756|SUPERIORITY||Cox Proportional Hazard|0.75||||0.51|TWO_SIDED|95.0|0.31|1.77|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for vitamin E||1.77|0.31|0.51
71922696|NCT00784225|143365757|SUPERIORITY||Cox Proportional Hazard|0.91||||0.37|TWO_SIDED|95.0|0.75|1.11|||Regression, Cox|||||1.11|0.75|0.37
71922697|NCT00784225|143365757|SUPERIORITY||Cox Proportional Hazard|1.02||||0.81|TWO_SIDED|95.0|0.84|1.25|||Regression, Cox|||||1.25|0.84|0.81
71922698|NCT00784225|143365758|SUPERIORITY||Cox Proportional Hazard|2.5||||0.12|TWO_SIDED|95.0|0.79|7.98|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for selenium||7.98|0.79|0.12
71922699|NCT00784225|143365758|SUPERIORITY||Cox Proportional Hazard|0.99||||0.98|TWO_SIDED|95.0|0.35|2.82|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for vitamin E||2.82|0.35|0.98
71922700|NCT00784225|143365759|SUPERIORITY||Cox Proportional Hazard|0.84||||0.19|TWO_SIDED|95.0|0.64|1.09|||Regression, Cox|||||1.09|0.64|0.19
71922701|NCT00784225|143365759|SUPERIORITY||Cox Proportional Hazard|1.08||||0.58|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||||1.41|0.83|0.58
71688768|NCT04633291|142892939|NON_INFERIORITY|Based on previous studies, the weighted average VAS discomfort level in healthy subjects using SpeediCath®Standard male was estimated at 2.3 cm, with 50% increase in VAS was considered clinically relevant. The mean difference non-inferiority margin between catheter coatings was therefore set to 1.2 cm, and non-inferiority was demonstrated if the mean difference was not above 1.2 cm.|Mean Difference (Final Values)|-0.15||||0.19|TWO_SIDED|95.0|-0.38|0.08||The threshold for statistical significance was set at 0.05.|Mixed Models Analysis|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.||At a 85% power level, the sample size needed to demonstrate non-inferiority of the novel coating to the original the coating was 18 subjects (participants). This was based on a standard deviation of 1.6 cm, a within subject correlation of 0.5 cm, and an assumption of same VAS distribution for the investigational device as for the comparator. With an expected drop-out rate of 20%, 22 subjects were included.||0.08|-0.38|0.19
71688769|NCT04633291|142892940|SUPERIORITY||Odds Ratio (OR)|1.76||||0.381|TWO_SIDED|95.0|0.47|6.6||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.|Null hypothesis: No difference between the devices.||6.60|0.47|0.381
71688770|NCT04633291|142892941|SUPERIORITY||Odds Ratio (OR)|7.8||||0.541|TWO_SIDED|95.0|-18.4|34.0||The threshold for statistical significance was set at 0.05.|Proportional odds model|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|"OR=1 corresponds to exact equality. OR \>1 means that the investigational device is evaluated easier than the comparator. OR \<1 means that the comparator device is evaluated easier than the investigational device.~Of note: Log transformed estimates."|Null hypothesis: No difference between the devices.||34.00|-18.40|0.541
71688771|NCT04633291|142892942|SUPERIORITY||Odds Ratio (OR)|7.17||||0.269|TWO_SIDED|95.0|0.19|265.95||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||265.95|0.19|0.269
71922702|NCT00313716|143365760|SUPERIORITY_OR_OTHER|||||||0.01||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo2 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo2 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 2 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups. Using a one-sided alpha of 0.15, a sample size of 62 subjects in the Epo 2 regimen group and 100 subjects in the placebo group provided 91% power to test the futility hypothesis.||||.01
71922703|NCT00313716|143365760|SUPERIORITY_OR_OTHER|||||||0.13||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo1 group - in Placebo group is \>= 0.2.~H1: Proportion in Epo1 group - in Placebo group \< 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 1 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups.||||0.13
71922704|NCT00313716|143365760|SUPERIORITY_OR_OTHER|||||||0.34|||||||2-sample test of proportions|||We hypothesized that 40% of the patients in the TT7 group would have a favorable GOS score and that there would be no interaction between the Epo and TT groups. Assuming a 2-sided test with an alpha level of 0.05, we estimated that a sample size of 200 patients would provide 80% power to detect a 20% absolute increase in the GOS score for the TT10 group.||||.34
71922705|NCT00313716|143365761|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||.06
71922706|NCT00313716|143365762|SUPERIORITY_OR_OTHER|||||||0.25|||||||Log Rank|||||||.25
71922707|NCT00313716|143365762|SUPERIORITY_OR_OTHER|||||||0.75|||||||Log Rank|||||||.75
71922708|NCT00313716|143365762|SUPERIORITY_OR_OTHER|||||||0.72|||||||Log Rank|||||||.72
71922709|NCT00313716|143365763|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79||||0.08|TWO_SIDED|95.0|0.93|3.45|||Regression, Cox|||||3.45|.93|.08
71922710|NCT00313716|143365764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.26|TWO_SIDED|95.0|-0.22|0.05|||2-sample test - equality of proportions|||||.05|-.22|.26
71922711|NCT01347931|143365791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|7.0|<|0.05|TWO_SIDED|95.0|2.0|10.0|||t-test, 2 sided|||A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).||10|2|<0.05
71922712|NCT01347931|143365792|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|1.0|7.0|||t-test, 2 sided|||Two-tailed t test||7|1|<0.05
71883172|NCT04770389|143285768|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
71761088|NCT03523988|143023695|SUPERIORITY|||||||0.53||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA|||||||0.53
71883173|NCT04770389|143285769|SUPERIORITY||Least Squares (LS) Mean|-43.33|STANDARD_ERROR_OF_MEAN|5.517|<|0.0001|TWO_SIDED|95.0|-54.29|-32.36|||ANCOVA|||||-32.36|-54.29|<0.0001
71883174|NCT04770389|143285770|SUPERIORITY||Least Squares (LS) Means|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
71883175|NCT04770389|143285771|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
71883176|NCT04770389|143285772|SUPERIORITY||Least Squares (LS) Mean|-33.36|STANDARD_ERROR_OF_MEAN|5.176|<|0.0001|TWO_SIDED|95.0|-43.63|-23.09|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-23.09|-43.63|<0.0001
71883177|NCT04770389|143285773|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
71883178|NCT04770389|143285774|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
71883179|NCT04770389|143285775|SUPERIORITY||Least Squares (LS) Mean|-28.2|STANDARD_ERROR_OF_MEAN|5.596|<|0.0001|TWO_SIDED|95.0|-39.32|-17.08|||ANCOVA|||||-17.08|-39.32|<0.0001
71883180|NCT04770389|143285776|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
71883181|NCT04770389|143285777|SUPERIORITY||Least Squares (LS) Mean|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
71883182|NCT04770389|143285778|SUPERIORITY||Least Squares (LS) Means|-29.62|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-37.12|-22.12|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-22.12|-37.12|<0.0001
71883183|NCT04770389|143285779|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
71883184|NCT04770389|143285780|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
71883185|NCT04770389|143285781|SUPERIORITY||Least Squares (LS) Mean|-22.36|STANDARD_ERROR_OF_MEAN|3.768|<|0.0001|TWO_SIDED|95.0|-29.83|-14.88|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-14.88|-29.83|<0.0001
71883186|NCT04770389|143285782|SUPERIORITY||Least Squares (LS) Means|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
71883187|NCT04770389|143285783|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
71883188|NCT04770389|143285784|SUPERIORITY||Least Squares (LS) Mean|-30.13|STANDARD_ERROR_OF_MEAN|5.254|<|0.0001|TWO_SIDED|95.0|-40.55|-19.71|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-19.71|-40.55|<0.0001
71883189|NCT04770389|143285785|SUPERIORITY||Least Squares (LS) Means|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
71883190|NCT04770389|143285786|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
71883191|NCT04770389|143285787|SUPERIORITY||Least Squares (LS) Mean|-18.58|STANDARD_ERROR_OF_MEAN|5.196||0.0005|TWO_SIDED|95.0|-28.88|-8.27|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-8.27|-28.88|0.0005
71883192|NCT04770389|143285788|SUPERIORITY||Least Squares (LS) Means|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
71883193|NCT04770389|143285789|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
71883194|NCT04770389|143285790|SUPERIORITY||Least Squares (LS) Mean|-14.79|STANDARD_ERROR_OF_MEAN|5.165||0.0051|TWO_SIDED|95.0|-25.03|-4.54|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-4.54|-25.03|0.0051
71761089|NCT03523988|143023695|SUPERIORITY|||||||0.31||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA|||||||0.31
71883195|NCT04770389|143285791|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
71883196|NCT04770389|143285792|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
71883197|NCT04770389|143285793|SUPERIORITY||Least Squares (LS) Mean|-12.77|STANDARD_ERROR_OF_MEAN|5.58||0.0245|TWO_SIDED|95.0|-23.86|-1.68|||ANCOVA|||||-1.68|-23.86|0.0245
71883198|NCT04770389|143285794|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
71883199|NCT04770389|143285795|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
71883200|NCT04770389|143285796|SUPERIORITY||Least Squares (LS) Mean|-20.81|STANDARD_ERROR_OF_MEAN|3.822|<|0.0001|TWO_SIDED|95.0|-28.39|-13.22|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-13.22|-28.39|<0.0001
71761090|NCT03523988|143023695|SUPERIORITY|||||||0.37||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA|||||||0.37
71883201|NCT02249143|143285798|SUPERIORITY||Mean Difference (Net)|6.62|||<|0.05|TWO_SIDED|95.0|0.02|13.22|||Regression, Linear|||FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.||13.22|0.02|<0.05
71883202|NCT02249143|143285799|SUPERIORITY||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71883203|NCT02249143|143285799|SUPERIORITY|||||||||||||||||Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.||||
71883204|NCT01783080|143285811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4||||0.005|TWO_SIDED||||||Regression, Linear|||||||0.005
71883205|NCT01783080|143285813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.11|TWO_SIDED||||||Regression, Linear|||||||0.11
71883206|NCT02533063|143285817|SUPERIORITY|||||||0.217|||||||ANOVA|||||||0.217
71883207|NCT02533063|143285818|SUPERIORITY|||||||0.501|||||||ANOVA|||||||0.501
71883208|NCT02533063|143285819|SUPERIORITY|||||||0.151|||||||ANOVA|||||||0.151
71883209|NCT02533063|143285820|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.450
71883210|NCT02533063|143285821|SUPERIORITY|||||||0.678|||||||ANOVA|||||||0.678
71883211|NCT02533063|143285822|SUPERIORITY|||||||0.06|||||||ANOVA|||||||0.060
71883212|NCT02533063|143285825|SUPERIORITY|||||||0.483|||||||ANOVA|||||||0.483
71883213|NCT00159861|143285840|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.095|||||TWO_SIDED|95.0|0.059|0.132||||||1 Year: Proportion of participants who died.||0.132|0.059|
71883214|NCT00159861|143285840|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.194|||||TWO_SIDED|95.0|0.144|0.243||||||2 Years: Proportion of participants who died.||0.243|0.144|
71883215|NCT00159861|143285840|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.26|||||TWO_SIDED|95.0|0.205|0.315||||||3 Years: Proportion of participants who died.||0.315|0.205|
71883216|NCT00159861|143285840|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.291|||||TWO_SIDED|95.0|0.234|0.348||||||4 Years: Proportion of participants who died.||0.348|0.234|
71883217|NCT00159861|143285840|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier estimate|0.369|||||TWO_SIDED|95.0|0.302|0.437||||||5 Years: Proportion of participants who died.||0.437|0.302|
71883218|NCT01500759|143285900|OTHER||Odds Ratio (OR)|1.9|||||TWO_SIDED|95.0||||||||||||
71883219|NCT01500759|143285901|OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0||||||||||||
71883220|NCT01500759|143285902|OTHER||Odds Ratio (OR)|0.92|||||TWO_SIDED|||||||||||||
71883221|NCT01500759|143285903|OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0||||||||||||
71883222|NCT01290874|143285906|SUPERIORITY|||||||0.31|||||||Log Rank|||||||0.31
71922713|NCT01249404|143365794|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-0.1|||=|0.2859|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.1|-0.3|=0.2859
71922714|NCT01249404|143365794|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|||=|0.0091|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||-0.1|-0.5|=0.0091
71922715|NCT01249404|143365795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.064|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0640
71922716|NCT01249404|143365795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.3|||=|0.0665|TWO_SIDED|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.5|-0.0|=0.0665
71922717|NCT01249404|143365795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0466|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0466
71922718|NCT01249404|143365795|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.2||||0.0406|TWO_SIDED||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.||||0.0406
71922719|NCT01249404|143365796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|||=|0.7247|TWO_SIDED|95.0|-0.02|0.03|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.03|-0.02|=0.7247
71922720|NCT01249404|143365796|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.01|||=|0.7266|TWO_SIDED|95.0|-0.03|0.02|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.||0.02|-0.03|=0.7266
71922721|NCT01020812|143365818|SUPERIORITY_OR_OTHER||proportion of participants|0.286|||||TWO_SIDED|95.0|0.031|0.636|||||The data was analyzed in a competing risk model with death as a competing risk. The proportion of 0.286 is the cumulative incidence function at 12 months.|The data was analyzed in a competitive risk model with the cumulative incidence function as the estimator. Death and other progression were competitive risks.||0.636|0.031|
71922722|NCT01020812|143365819|SUPERIORITY_OR_OTHER||probability|0.4|||||TWO_SIDED||||||||This is the overall survival probability at 18 months.|The data was analyzed using the Kaplan Meier estimator.||||
71922723|NCT01716585|143365827|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.|Percentage of Participants with SVR12|96.4|||||TWO_SIDED|95.0|94.7|98.1|||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.||98.1|94.7|
71922724|NCT01716585|143365828|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|Fisher Exact|||||||< 0.001
71922725|NCT01716585|143365829|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|95.7|||||TWO_SIDED|95.0|93.4|97.9||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|||95% CI calculated using the normal approximation to the binomial distribution.|||97.9|93.4|
71922726|NCT01716585|143365830|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|98.0|||||TWO_SIDED|95.0|95.8|100.0|||||95% CI calculated using the normal approximation to the binomial distribution.|||100.0|95.8|
71922727|NCT01707667|143365835|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.012|TWO_SIDED|95.0|1.6|9.9|||Linear Mixed-Effect Models Analysis|||||9.9|1.6|0.012
71922728|NCT01707667|143365836|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|69051.4||||0.079|TWO_SIDED|95.0|-12004.5|150107.3|||Linear Mixed-Effect Models Analysis|||||150107.3|-12004.5|0.079
71922729|NCT01707667|143365837|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2||||0.717|TWO_SIDED|95.0|-45.3|63.7|||Linear Mixed-Effect Models Analysis|||||63.7|-45.3|0.717
71922730|NCT01707667|143365838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED||||||Log Rank|||||||0.295
71922731|NCT01707667|143365839|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.179||||0.18|TWO_SIDED|95.0|-0.465|0.107|||Linear Mixed-Effect Models Analysis|||||0.107|-0.465|0.180
71922732|NCT01707667|143365840|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.8||||0.225|TWO_SIDED|95.0|-12.6|44.3|||Linear Mixed-Effect Models Analysis|||||44.3|-12.6|0.225
71922733|NCT03802331|143365843|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|166.02|||||TWO_SIDED|90.0|143.17|192.53|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 19.0.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||192.53|143.17|
71922734|NCT03802331|143365844|OTHER|Relative bioavailability|Ajusted Geometric Mean Ratio T/R (%)|235.5|||||TWO_SIDED|90.0|179.82|308.42|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 35.4.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||308.42|179.82|
71922735|NCT03802331|143365845|OTHER|Relative bioavailability|Adjusted Geometric Mean Ratio T/R (%)|159.39|||||TWO_SIDED|90.0|140.11|181.34|||||The Adjusted Geometric Mean is adjusted by treatment. Geometric coefficient of variation (gCV) = 16.5.|This model included effects accounting for the following sources of variation: sequence, subjects within sequences, period, and treatment.||181.34|140.11|
71922736|NCT00851721|143365878|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Two-sample, two-sided t-test|||H0: μ(on-demand) = μ(prophylaxis) Versus H1: μ(on-demand) ≠ μ(prophylaxis) (Where H0 implies no difference in mean bleeding episode rate between prophylaxis and on-demand treatment arms and H1 implies otherwise. This test was performed at a significance level of 5%, two-sided, two sample)||||0.0003
71922737|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|||||||Two-sample, two-sided t-test|||Spontaneous Bleeds||||0.0008
71922738|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0199|||||||Two-sample, two-sided t-test|||Traumatic Bleeds||||0.0199
71922739|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0006|||||||Two-sample, two-sided t-test|||Joint Bleeds||||0.0006
71922740|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0227|||||||Two-sample, two-sided t-test|||Non-Joint Bleeds||||0.0227
71922741|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0013|||||||Two-sample, two-sided t-test|||Spontaneous Joint Bleeds||||0.0013
71922742|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|||||||Two-sample, two-sided t-test|||Spontaneous Non-Joint Bleeds||||0.0030
71922743|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0254|||||||Two-sample, two-sided t-test|||Traumatic Joint Bleeds||||0.0254
71922744|NCT00851721|143365880|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9322|||||||Two-sample, two-sided t-test|||Traumatic Non-Joint Bleeds||||0.9322
71922745|NCT00851721|143365882|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0271|||||||Two-sample, two-sided t-test|||||||0.0271
71922746|NCT00851721|143365889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0067||95.0|||||Mann-Whitney tests (Wilcoxon-Rank Sum)|||||||0.0067
71922747|NCT03485976|143365940|OTHER||||||<|0.001||||||The threshold for statistical significance was p=0.05|t-test, 2 sided|||||||<0.001
71922748|NCT03485976|143365941|OTHER|||||||0.004||||||The threshold for significance was p=0.05|t-test, 2 sided|||||||0.004
71922749|NCT03485976|143365942|OTHER|||||||0.001||||||Threshold for significance was p=0.05|t-test, 2 sided|||||||0.001
71922750|NCT03547960|143365958|SUPERIORITY|||||||0.639|||||||Chi-squared|||||||0.639
71922751|NCT03547960|143365958|SUPERIORITY|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||||||0.283
71922752|NCT03547960|143365960|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||||||0.564
71922753|NCT03524664|143366000|SUPERIORITY|||||||0.523||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71) = 0.411, p =.523||Repeated measures ANOVA||||.523
71922754|NCT03524664|143366001|SUPERIORITY|||||||0.173||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.89, p=.173||Repeated measures ANOVA||||.173
71922755|NCT03524664|143366002|SUPERIORITY|||||||0.14||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.23, p=.140||Outcome data analyzed for those with complete data at both timepoints.||||.140
71922756|NCT03524664|143366003|SUPERIORITY|||||||0.845||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.039, p=0.845||Outcome data analyzed for those with complete data at both timepoints.||||0.845
71922757|NCT03524664|143366004|SUPERIORITY|||||||0.147||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=2.147, p=.147||Outcome data analyzed for those with complete data at both timepoints.||||.147
71922758|NCT03524664|143366005|SUPERIORITY|||||||0.429||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=.633, p=.429||Outcome data analyzed for those with complete data at both timepoints.||||.429
71922759|NCT03524664|143366006|SUPERIORITY|||||||0.208||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,70)=1.618, p=.208||Outcome data analyzed for those with complete data at both timepoints.||||.208
71922760|NCT03524664|143366007|SUPERIORITY|||||||0.3||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=1.09, p=.300||Outcome data analyzed for those with complete data at both timepoints.||||.300
71922761|NCT03524664|143366008|SUPERIORITY|||||||0.099||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.79, p=.099||Outcome data analyzed for those with complete data at both timepoints.||||.099
71922762|NCT03524664|143366009|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=2.70, p=.105||Outcome data analyzed for those with complete data at both timepoints.||||.105
71922763|NCT03524664|143366010|SUPERIORITY|||||||0.699||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.15, p=.699||Repeated measures ANOVA||||.699
71922764|NCT03524664|143366011|SUPERIORITY|||||||0.945||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.005, p=.945||Repeated measures ANOVA||||.945
71922765|NCT03524664|143366012|SUPERIORITY|||||||0.767||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=0.088, p=.767||Repeated measures ANOVA||||.767
71922766|NCT03524664|143366013|SUPERIORITY|||||||0.682||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,71)=.0.17, p=.682||Repeated measures ANOVA||||.682
71922767|NCT03524664|143366014|SUPERIORITY|||||||0.96||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.003, p=.960||Repeated measures ANOVA||||.960
71922768|NCT03524664|143366015|SUPERIORITY|||||||0.643||||||The threshold for statistical significance was p = 0.05.|ANOVA|F(1,42)=0.218, p=.643||Repeated measures ANOVA||||.643
71922769|NCT03524664|143366016|SUPERIORITY|||||||0.118||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time X Group F(2,90)=2.19, p.118||Repeated measures ANOVA||||.118
71922770|NCT03524664|143366017|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.05.|ANOVA|Time x Group F(2,90)=.223, p=.800||Repeated measures ANOVA||||.800
71922771|NCT03524664|143366018|SUPERIORITY|||||||0.863||||||The threshold for statistical significance was p = 0.05.|ANOVA|Group x Time F(2,92)=0.148, p=.863||Repeated measures ANOVA||||.863
71922772|NCT00877929|143366050|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.2|-7.9|0.0001
71922773|NCT00877929|143366051|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1||||0.0001||95.0|-8.9|-5.4|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-5.4|-8.9|0.0001
71922774|NCT00877929|143366052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.0001||95.0|-8.3|-4.9|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.9|-8.3|0.0001
71922775|NCT00877929|143366053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.3|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-4.3|-7.9|0.0001
71922776|NCT00877929|143366054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.9||||0.0001||95.0|-6.6|-3.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.||||-3.2|-6.6|0.0001
71922777|NCT01140646|143366091|SUPERIORITY_OR_OTHER|||||||0.0903||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash score is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.0903
71922778|NCT01140646|143366091|SUPERIORITY_OR_OTHER|||||||0.1553||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash frequency is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.||||0.1553
71922779|NCT03006276|143366096|SUPERIORITY||Odds Ratio (OR)|2.0|||<|0.001|TWO_SIDED|95.0|1.36|2.94|||Fisher Exact|||Last Observation Carried Forward (LOCF)||2.94|1.36|<0.001
71922780|NCT03006276|143366096|SUPERIORITY||Odds Ratio (OR)|1.97|||<|0.001|TWO_SIDED|95.0|1.34|2.89|||Fisher Exact|||||2.89|1.34|<0.001
71922781|NCT03006276|143366097|SUPERIORITY||Odds Ratio (OR)|1.68||||0.007|TWO_SIDED|95.0|1.17|2.43|||Fisher Exact|||last observation carried forward (LOCF)||2.43|1.17|0.007
71922782|NCT03006276|143366097|SUPERIORITY||Odds Ratio (OR)|1.69||||0.007|TWO_SIDED|95.0|1.16|2.44|||Fisher Exact|||observed cases (OC)||2.44|1.16|0.007
71922783|NCT00689728|143366123|SUPERIORITY_OR_OTHER|||||||0.178||95.0|||||Fisher Exact|||||||0.178
71922784|NCT00689728|143366123|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Fisher Exact|||||||0.116
71922785|NCT00689728|143366125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.873||||0.062||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.062
71922786|NCT00689728|143366125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.427||||0.052||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Physical Health Component scores.|ANCOVA|||||||0.052
71922787|NCT00689728|143366125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.72||||0.655||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.655
71922788|NCT00689728|143366125|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.264||||0.173||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Mental Health Component scores.|ANCOVA|||||||0.173
71922789|NCT00689728|143366126|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||Fisher Exact|||||||0.281
71922790|NCT00689728|143366126|SUPERIORITY_OR_OTHER|||||||0.218||95.0|||||Fisher Exact|||||||0.218
71922791|NCT00689728|143366127|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Fisher Exact|||||||0.500
71922792|NCT00689728|143366127|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||Fisher Exact|||||||0.444
71922793|NCT00689728|143366128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.337||95.0|||||ANCOVA|||||||0.337
71922794|NCT00689728|143366128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.6||||0.038||95.0|||||ANCOVA|||||||0.038
71922795|NCT00689728|143366129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7||||0.403||95.0|||||ANCOVA|||||||0.403
71922796|NCT00689728|143366129|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.006||95.0|||||ANCOVA|||||||0.006
71922797|NCT00689728|143366130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2||||0.168||95.0|||||ANCOVA|||||||0.168
71922798|NCT00689728|143366130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.075||95.0|||||ANCOVA|||||||0.075
71922799|NCT00689728|143366131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.3||||0.157||95.0|||||ANCOVA|||||||0.157
71922800|NCT00689728|143366131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6||||0.025||95.0|||||ANCOVA|||||||0.025
71922801|NCT00689728|143366132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4||||0.11||95.0|||||ANCOVA|||||||0.110
71922802|NCT00689728|143366132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.1||||0.147||95.0|||||ANCOVA|||||||0.147
71922803|NCT00689728|143366133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.172||||0.969||95.0|||||ANCOVA|||||||0.969
71922804|NCT00689728|143366133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.452||95.0|||||ANCOVA|||||||0.452
71922805|NCT00689728|143366134|SUPERIORITY_OR_OTHER|||||||0.554||95.0|||||ANCOVA|||||||0.554
71922806|NCT00689728|143366134|SUPERIORITY_OR_OTHER|||||||0.92||95.0|||||ANCOVA|||||||0.920
71922807|NCT00689728|143366135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.912||||0.1||95.0|||||ANCOVA|||||||0.100
71922808|NCT00689728|143366135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.322||||0.005||95.0|||||ANCOVA|||||||0.005
71922809|NCT00689728|143366136|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||p-value represents comparison of LY2127399-30 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.022
71922810|NCT00689728|143366136|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value represents comparison of LY2127399-80 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact|||||||0.016
71922811|NCT00689728|143366137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.818||95.0|||||ANCOVA|||||||0.818
71922812|NCT00689728|143366137|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.7||||0.066||95.0|||||ANCOVA|||||||0.066
71922813|NCT00689728|143366138|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||ANCOVA|||||||0.010
71922814|NCT00689728|143366138|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||ANCOVA|||||||0.056
71922815|NCT00689728|143366139|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
71922816|NCT00689728|143366139|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
71922817|NCT00689728|143366140|SUPERIORITY_OR_OTHER|||||||0.146||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.146
71922818|NCT00689728|143366140|SUPERIORITY_OR_OTHER|||||||0.125||95.0||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA|||||||0.125
71922819|NCT00689728|143366140|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||<0.001
71922820|NCT00689728|143366140|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA|||||||0.005
71922821|NCT00689728|143366140|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.115
71922822|NCT00689728|143366140|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA|||||||0.019
71922823|NCT03245372|143366143|SUPERIORITY|||||||0.114|||||||Wilcoxon (Mann-Whitney)|||||||0.114
71922824|NCT03245372|143366144|SUPERIORITY|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.692
71922825|NCT03245372|143366145|SUPERIORITY|||||||0.082|||||||t-test, 2 sided|||||||0.082
71922826|NCT03245372|143366146|SUPERIORITY|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
71922827|NCT03245372|143366147|SUPERIORITY|||||||0.668|||||||t-test, 2 sided|||||||0.668
71922828|NCT03245372|143366148|SUPERIORITY|||||||0.516|||||||Chi-squared|||||||0.516
71922829|NCT03245372|143366150|SUPERIORITY|||||||0.229|||||||Wilcoxon (Mann-Whitney)|||||||0.229
71922830|NCT03245372|143366151|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1
71922831|NCT04047342|143366152|SUPERIORITY||Odds Ratio (OR)|0.97||||0.828|TWO_SIDED|95.0|0.72|1.3||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.30|0.72|.828
71922832|NCT00660829|143366158|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5633|STANDARD_DEVIATION|0.3345|<|0.001||95.0|-2.22|-0.91|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.91|-2.22|<0.001
71922833|NCT00660829|143366159|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7444|STANDARD_ERROR_OF_MEAN|0.1677|<|0.001||95.0|-1.07|-0.42|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.42|-1.07|<0.001
71922834|NCT00660829|143366160|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4403|STANDARD_DEVIATION|0.3406|<|0.001||95.0|-2.11|-0.77|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||||-0.77|-2.11|<0.001
71922835|NCT00660829|143366161|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2907|STANDARD_DEVIATION|0.3204|<|0.001||95.0|-1.92|0.66|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline||0.66|-1.92|<0.001
71922836|NCT00660829|143366162|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANCOVA|||Change from baseline||||0.001
71922837|NCT02127931|143366165|OTHER|||||||0.005|||||||Correlation|||ADHD-I||||0.005
71922838|NCT02127931|143366165|OTHER|||||||0.023|||||||Correlation|||ADHD-C||||0.023
71922839|NCT02127931|143366166|OTHER|||||||0.013|||||||Correlation|||||||0.013
71922840|NCT03395704|143366234|SUPERIORITY||||||<|0.0001|||||||General Linear Model|||||||< 0.0001
71922841|NCT03539900|143366238|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.44|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a moderator or predictor.||||||.44
71922842|NCT03539900|143366239|SUPERIORITY|Analyses used all available data. Analyses to compare treatments were all intent-to-treat.||||||0.04|||||||Mixed Models Analysis|Analyses were performed for all randomized participants. Models also considered weight status as a predictor or moderator.||||||.04
71922843|NCT03539900|143366240|SUPERIORITY|||||||0.98|||||||ANOVA|Analyses used all available data without imputation.||||||.98
71922844|NCT03539900|143366241|SUPERIORITY|||||||0.44|||||||ANOVA|Analyses used all available data without imputation.||||||.44
71922845|NCT03539900|143366242|SUPERIORITY|||||||0.99|||||||ANOVA|Analyses used all available data without imputation.||||||.99
71922846|NCT03539900|143366243|SUPERIORITY|||||||0.4|||||||ANOVA|Analyses used all available data without imputation.||||||.40
71922847|NCT04823494|143366244|NON_INFERIORITY|For sample size in each sequence group is 16 (total N=32), a 2 X 2 crossover design will have 80% power to reject the null hypothesis that the SELF-FIT APHAB mean is inferior to the PRO-FIT APHAB mean. The non-inferiority difference margin is 8.4, the standard deviation of differences is 16.3, and p\<.025. The non-inferiority margin of 8.4 preserves half the 95% critical difference for the global APHAB score (16.8). The common standard deviation reported for the APHAB global score is 16.0.|Mean Difference (Final Values)|1.4|||<|0.025|TWO_SIDED|95.0|-1.59|4.73||There were two outcome measures, primary and secondary, considered. As a result, the a priori p value of .05 for statistical significance was adjusted for multiple comparisons to .025.|t-test, 1 sided|The mean differences and 95% CIs in APHAB global score between SELF-FIT and PRO-FIT were calculated using bias-corrected \& accelerated bootstrapping.|The mean difference and 95% CIs are for Self-Fit minus Pro-Fit aided scores. These values are the pooled data for all 37 participants, 19 receiving one sequence and 18 the other sequence.|"For the wear-time crossover field trial, the APHAB was measured following both the audiology best-practices hearing aid fitting (PRO-FIT) and the self-fitting method (SELF-FIT).~* Null hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT ) ≥ 8.4~* Alternative hypothesis: Mean (APHAB SELF-FIT - APHAB PRO-FIT) \< 8.4~The mean difference between the aided scores for the two fitting methods, Self-Fit minus Pro-Fit, represent the primary outcome measure. The expected difference = 0."||4.73|-1.59|<0.025
71922848|NCT04823494|143366245|NON_INFERIORITY|For the QuickSIN, a clinically meaningful difference is 3 dB and half that difference resulted in a margin of 1.5 dB. This 1.5-dB margin was used for the QuickSIN for the non-inferiority analyses of the data from the field-trial component. The mean difference, QuickSIN Self-Fit minus QuickSIN Pro-Fit, should be less than 1.5 dB for the entire sample (N=37) to meet the non-inferiority criterion.|Mean Difference (Final Values)|0.58|||<|0.025|TWO_SIDED|95.0|-0.03|1.2||The a priori threshold value of 0.05 was Bonferroni-adjusted to 0.025 based on the use of two outcome measures, APHAB global (primary) and QuickSIN (secondary).|t-test, 1 sided|The mean differences in dB, SELF-FIT minus PRO-FIT, were calculated with 95% confidence intervals (bias-corrected, accelerated bootstrap) generated.|Mean differences in aided QuickSIN SNR in dB, Self-Fit minus Pro-Fit, were calculated for the entire group of 37 participants with about 1/2 receiving one of the two fit sequences (Pro-Fit then Self-Fit or Self-Fit then Pro-Fit).|"For the QuickSIN, aided performance after each wear period was compared between SELF-FIT and PRO-FIT.~* Null hypothesis: Mean (QuickSIN SELF-FIT - QuickSIPRO-FIT) ≥ 1.5 dB~* Alternative hypothesis: Mean (QuickSIN SELF-FIT - QuickSIN PRO-FIT) \< 1.5 dB~Power calculations were based on the primary outcome measured, the aided APHAB global score, (see information for that outcome measure). With the minimum required N of 32 based on the APHAB global score, the power for QuickSIN exceeded 80%."||1.20|-0.03|<0.025
71922849|NCT03691831|143366258|SUPERIORITY||Odds Ratio (OR)|4.8||||0.0001|TWO_SIDED|95.0|2.14|10.76||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.|Mixed Models Analysis|||A summary of the wart clearance at Visit 10.||10.76|2.14|0.0001
71922850|NCT03691831|143366259|SUPERIORITY||Mean Difference (Final Values)|2.71||||0.0001|TWO_SIDED|95.0|1.61|4.56|||Mixed Models Analysis|||P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.||4.56|1.61|0.0001
71922851|NCT03691831|143366260|SUPERIORITY||Odds Ratio (OR)|15.44|||<|0.0001|TWO_SIDED|95.0|9.0|21.8|||Wilcoxon (Mann-Whitney)|||||21.8|9.0|<0.0001
71922852|NCT03691831|143366261|SUPERIORITY||Odds Ratio (OR)|5.2||||0.0006|TWO_SIDED|95.0|1.76|15.53|||Wilcoxon (Mann-Whitney)|||||15.53|1.76|0.0006
71922853|NCT03691831|143366262|SUPERIORITY||Hazard Ratio (HR)|3.33|||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71922854|NCT03922945|143366263|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71922855|NCT03922945|143366264|SUPERIORITY||||||<|0.0017|||||||Cochran-Mantel-Haenszel|||||||<0.0017
71922856|NCT03922945|143366271|SUPERIORITY|||||||0.7465|||||||Mixed Models Analysis|||||||0.7465
71922857|NCT02528643|143366276|SUPERIORITY||Hazard Ratio (HR)|1.146||||0.248|TWO_SIDED|95.0|0.774|1.696||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by geographic region and ECOG performance status. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.696|0.774|0.248
71922858|NCT02528643|143366276|SUPERIORITY||Hazard Ratio (HR)|1.142||||0.252|TWO_SIDED|95.0|0.773|1.688||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.688|0.773|0.252
71922859|NCT02528643|143366281|SUPERIORITY||Hazard Ratio (HR)|1.039||||0.396|TWO_SIDED|95.0|0.732|1.474||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by ECOG performance status and region. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.||1.474|0.732|0.396
71922860|NCT02528643|143366281|SUPERIORITY||Hazard Ratio (HR)|0.959||||0.586|TWO_SIDED|95.0|0.684|1.345||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio \< 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.||1.345|0.684|0.586
71922861|NCT04120116|143366282|SUPERIORITY||Odds Ratio (OR)|0.3||||0.068|TWO_SIDED|95.0|0.11|1.08||P value for statistical significance is \<0.05|Mixed Models Analysis|||||1.08|0.11|0.068
71922862|NCT04120116|143366284|SUPERIORITY||Least squares mean difference|1.25|STANDARD_ERROR_OF_MEAN|2.611||0.634|TWO_SIDED|95.0|-3.945|6.439||P value for statistical significance is \<0.05|Mixed Models Analysis|||||6.439|-3.945|0.634
71922863|NCT02087085|143366288|SUPERIORITY||Least Squares Mean Difference|-0.3589|STANDARD_ERROR_OF_MEAN|0.1804||0.047|TWO_SIDED|95.0|-0.7132|-0.0047||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||-0.0047|-0.7132|0.047
71922864|NCT02087085|143366289|SUPERIORITY||Least Squares Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|1.4||0.39|TWO_SIDED|95.0|-3.9|1.5||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.5|-3.9|0.390
71922865|NCT02087085|143366290|SUPERIORITY||Least Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|1.4||0.301|TWO_SIDED|95.0|-4.2|1.3||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM|||||1.3|-4.2|0.301
71922866|NCT01729559|143366325|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on a previous trial showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of unfractionated heparin (UFH) every 12 hr. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required.|Risk Difference (RD)|6.5||||0.025|TWO_SIDED|95.0|-2.9|15.8||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|Analysis was performed in a subset of patients who received at least one follow-up venous duplex ultrasound of the lower extremities.||15.8|-2.9|0.025
71922867|NCT01729559|143366325|NON_INFERIORITY_OR_EQUIVALENCE|A 10% noninferiority margin was selected based on these data showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of UFH every 12 hours. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required. This analysis was performed in the entire sample.|Risk Difference (RD)|3.1||||0.025|TWO_SIDED|95.0|-1.6|7.7||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|"Analysis was performed in the total sample of eligible patients and who received their assigned treatment (referred to as the randomized treated sample) ."||7.7|-1.6|0.025
71922868|NCT03764813|143366331|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
71922869|NCT03764813|143366332|SUPERIORITY||Median Difference (Final Values)|0.165|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71922870|NCT03764813|143366333|SUPERIORITY||Median Difference (Final Values)|0.537|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71922871|NCT03764813|143366334|SUPERIORITY||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).||||<0.0001
71922872|NCT04646668|143366340|SUPERIORITY|Due to the pilot nature of the current study, formal power calculations were not conducted.||||||0.002|||||||ANOVA|||The null hypothesis is that there is no difference in nicotine delivery between cigarettes, e-cigarettes, and heat not burn after the standardized 10-puff bout. ANOVAs were conducted to detect differences between products for nicotine concentration at five minutes (immediately following 10-puff bout). The test was performed with a significance level of 0.05 (two-sided).||||0.002
71922873|NCT03223649|143366409|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.035||0.005|TWO_SIDED|95.0|-0.17|-0.03||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.03|-.17|0.005
71922874|NCT03223649|143366410|SUPERIORITY||Mean Difference (Final Values)|-0.011|STANDARD_ERROR_OF_MEAN|0.011||0.349|TWO_SIDED|95.0|-0.033|0.011||Unadjusted P-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.011|-.033|0.349
71922875|NCT03223649|143366411|SUPERIORITY||Mean Difference (Final Values)|-0.043|STANDARD_ERROR_OF_MEAN|0.021||0.045|TWO_SIDED|95.0|-0.084|-0.002||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||-.002|-.084|.045
71922876|NCT03223649|143366412|SUPERIORITY||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.016||0.226|TWO_SIDED|95.0|-0.051|0.013||Unadjusted p-value|ANCOVA|Log-transformed value adjusted for: arcsine sqrt transformed % fat mass, pubertal stage (pre, early, or late), and basal analyte log transformed.||||0.013|-0.051|0.226
71922877|NCT03223649|143366413|SUPERIORITY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|0.545|<|0.001|TWO_SIDED|95.0|-6.884|-4.716|||t-test, 2 sided|||||-4.716|-6.884|<0.001
71922878|NCT03223649|143366414|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.116||0.39|TWO_SIDED|95.0|-0.33|0.13|||t-test, 2 sided|||||0.130|-0.330|0.39
71922879|NCT03223649|143366415|SUPERIORITY||Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.046||0.648|TWO_SIDED|95.0|-0.071|0.114|||ANCOVA|Dependent variable in Kcal log transformed, comparison adjusted for: age(y), lean mass(kg), fat mass(kg)||||0.114|-0.071|0.648
71922880|NCT03223649|143366416|SUPERIORITY||Mean Difference (Final Values)|0.834|STANDARD_ERROR_OF_MEAN|1.354||0.539|TWO_SIDED|95.0|-1.857|3.525|||ANCOVA|Adjusted for age (years)||||3.525|-1.857|0.539
71922881|NCT03223649|143366417|SUPERIORITY||Mean Difference (Final Values)|-1.06|STANDARD_ERROR_OF_MEAN|1.766||0.55|TWO_SIDED|95.0|-4.57|2.45|||ANCOVA|Adjusted for age (years)||||2.45|-4.57|0.550
71922882|NCT03223649|143366418|SUPERIORITY||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.681||0.741|TWO_SIDED|95.0|-1.127|1.579|||ANCOVA|Adjusted for age (years)||||1.579|-1.127|0.741
71922883|NCT04533204|143366419|SUPERIORITY||Mean Difference (Final Values)|18.47|||<|0.001|TWO_SIDED|95.0|12.28|24.67|||Mixed Models Analysis|||||24.67|12.28|<.001
71922884|NCT04533204|143366420|SUPERIORITY||Mean Difference (Final Values)|2.33||||0.004|TWO_SIDED|95.0|0.75|3.91||Performance on cued recall (error scores)|Mixed Models Analysis|||||3.91|.75|.004
71922885|NCT03982069|143366421|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
71922886|NCT03982069|143366422|OTHER||||||<|0.001||||||All listed antigens|Chi-squared|||||||<0.001
71922887|NCT03982069|143366423|OTHER||||||<|0.001||||||Day 28 for all listed antigens|Chi-squared|||||||<0.001
71922888|NCT03982069|143366423|OTHER|||||||0.4||||||Day 0, A/H1N1-A/Brisbane|Chi-squared|||||||0.40
71922889|NCT03982069|143366423|OTHER|||||||0.36||||||Day 0 A/H1N1-A/Kansas egg grown virus|Chi-squared|||||||0.36
71922890|NCT03982069|143366423|OTHER|||||||0.08||||||Day 0 A/H1N1-A/Kansas cell grown virus|Chi-squared|||||||0.08
71922891|NCT03982069|143366423|OTHER|||||||0.91||||||Day 0 B/Victoria-B/Colorado|Chi-squared|||||||0.91
71922892|NCT03982069|143366423|OTHER|||||||0.31||||||Day 0 B/Yamagata-B/Phuket|Chi-squared|||||||0.31
71922893|NCT03982069|143366424|OTHER|||||||0.79||||||Day 0 A/H1N1-A/Brisbane|t-test, 2 sided|||||||0.79
71922894|NCT03982069|143366424|OTHER|||||||0.79||||||Day 0 A/H3N2-A/Kansas egg grown virus|t-test, 2 sided|||||||0.79
71922895|NCT03982069|143366424|OTHER|||||||0.56||||||Day 0 A/H3N2-A/Kansas cell grown virus|t-test, 2 sided|||||||0.56
71922896|NCT03982069|143366424|OTHER|||||||0.95||||||Day 0 B/Victoria-B/Colorado|t-test, 2 sided|||||||0.95
71922897|NCT03982069|143366424|OTHER|||||||0.44||||||Day 0 B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.44
71922898|NCT03982069|143366424|OTHER||||||<|0.001||||||Day 28 for all listed variables|t-test, 2 sided|||||||<0.001
71922899|NCT03982069|143366425|OTHER|||||||0.83|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii66-egg based antigen||||||0.83
71922900|NCT03982069|143366425|OTHER|||||||0.79|||||||Chi-squared|Day 0: A/H1N1-A/Hawaii70-cell based antigen||||||0.79
71922901|NCT03982069|143366425|OTHER|||||||0.65|||||||Chi-squared|Day 0: A/H1N1-A/Delaware||||||0.65
71922902|NCT03982069|143366425|OTHER|||||||0.06|||||||Chi-squared|Day 0: A/H3N2-A/Hong Kong||||||0.06
71922903|NCT03982069|143366425|OTHER|||||||0.98|||||||Chi-squared|Day 0: B/Victoria-B/Washington||||||0.98
71922904|NCT03982069|143366425|OTHER|||||||0.24|||||||Chi-squared|Day 0: B/Yamagata-B/Phuket||||||0.24
71922905|NCT03982069|143366425|OTHER||||||<|0.01|||||||Chi-squared|Day 28: A/H1N1-A/Hawaii66-egg based antigen, A/H1N1-A/Hawaii70-cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket||||||<0.01
71922906|NCT03982069|143366425|OTHER|||||||0.66|||||||Chi-squared|A/H3N2-A/Hong Kong||||||0.66
71922907|NCT03982069|143366426|OTHER|||||||0.22||||||Day 0: A/H1N1-A/Hawaii66 egg based antigen|t-test, 2 sided|||||||0.22
71922908|NCT03982069|143366426|OTHER|||||||0.25||||||Day 0: A/H1N1-A/Hawaii70 cell based antigen|t-test, 2 sided|||||||0.25
71922909|NCT03982069|143366426|OTHER|||||||0.13||||||Day 0: A/H1N1-A/Delaware|t-test, 2 sided|||||||0.13
71922910|NCT03982069|143366426|OTHER|||||||0.06||||||Day 0: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.06
71922911|NCT03982069|143366426|OTHER|||||||0.78||||||Day 0: B/Victoria-B/Washington|t-test, 2 sided|||||||0.78
71922912|NCT03982069|143366426|OTHER|||||||0.36||||||Day 0: B/Yamagata-B/Phuket|t-test, 2 sided|||||||0.36
71922913|NCT03982069|143366426|OTHER||||||<|0.0001||||||Day 28: A/H1N1-A/Hawaii66 egg based antigen, A/H1N1-A/Hawaii70 cell based antigen, A/H1N1-A/Delaware, B/Victoria-B/Washington, B/Yamagata-B/Phuket|t-test, 2 sided|||||||<0.0001
71922914|NCT03982069|143366426|OTHER|||||||0.01||||||Day 28: A/H3N2-A/Hong Kong|t-test, 2 sided|||||||0.01
71922915|NCT03970330|143366435|SUPERIORITY||Mean Difference (Final Values)|1123.0||||0.2|TWO_SIDED|95.0|-755.0|3000.0|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||3000|-755|0.20
71922916|NCT03970330|143366436|SUPERIORITY||Mean Difference (Final Values)|28.9||||0.06|TWO_SIDED|95.0|-1.9|59.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at BASELINE||59.6|-1.9|0.06
71922917|NCT03970330|143366436|SUPERIORITY||Mean Difference (Final Values)|10.4||||0.48|TWO_SIDED|95.0|-20.3|41.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 4||41.2|-20.3|0.48
71922918|NCT03970330|143366436|SUPERIORITY||Mean Difference (Final Values)|18.9||||0.21|TWO_SIDED|95.0|-11.8|49.6|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 8||49.6|-11.8|0.21
71922919|NCT03970330|143366436|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.3|TWO_SIDED|95.0|-15.2|46.2|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 12||46.2|-15.2|0.30
71922920|NCT03970330|143366436|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.65|TWO_SIDED|95.0|-24.0|37.5|||Mixed Models Analysis|A single model was run with comparisons between naltrexone and placebo at each visit (not adjusted for multiple comparisons)|Difference calculated as Naltrexone minus Placebo|Comparison of treatment groups at WEEK 16||37.5|-24.0|0.65
71922921|NCT03970330|143366437|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.07
71922922|NCT03970330|143366437|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.07
71922923|NCT03970330|143366437|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.06
71922924|NCT03970330|143366437|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||1.00
71922925|NCT03970330|143366438|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Comparison of treament groups at WEEK 4||||0.29
71922926|NCT03970330|143366438|SUPERIORITY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.24
71922927|NCT03970330|143366438|SUPERIORITY|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.20
71922928|NCT03970330|143366438|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.53
71922929|NCT03970330|143366439|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 4||||0.37
71922930|NCT03970330|143366439|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 8||||0.39
71922931|NCT03970330|143366439|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 12||||0.37
71922932|NCT03970330|143366439|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at WEEK 16||||0.39
71922933|NCT03970330|143366440|SUPERIORITY||Mean Difference (Final Values)|4.3||||0.08|TWO_SIDED|95.0|-0.6|9.2|||t-test, 2 sided||Difference calculated as Naltrexone minus Placebo|||9.2|-0.6|0.08
71922934|NCT02242305|143366511|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.809|TWO_SIDED|90.0|-0.33|0.27|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.27|-0.33|0.809
71922935|NCT02242305|143366511|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.05||||0.809|TWO_SIDED|95.0|-0.39|0.33|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.|||0.33|-0.39|0.809
71922936|NCT02242305|143366512|SUPERIORITY_OR_OTHER|||||||0.079|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.||||||0.079
71922937|NCT02242305|143366517|SUPERIORITY_OR_OTHER|||||||0.531|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.||||||0.531
71922938|NCT03451630|143366518|SUPERIORITY|||||||0.0211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (6, 3152).||Overall Test of Group by Time Interaction||||0.0211
71922939|NCT03451630|143366518|SUPERIORITY||Mean Difference (Final Values)|2.69|STANDARD_ERROR_OF_MEAN|1.22||0.028|TWO_SIDED|95.0|0.29|5.09||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 4.83 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||5.09|0.29|0.0280
71922940|NCT03451630|143366518|SUPERIORITY||Mean Difference (Final Values)|2.07|STANDARD_ERROR_OF_MEAN|1.23||0.0935|TWO_SIDED|95.0|-0.35|4.48||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.81 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to 12-Months using linear contrast.||4.48|-0.35|0.0935
71922941|NCT03451630|143366518|SUPERIORITY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|1.05||0.5538|TWO_SIDED|95.0|-1.44|2.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.35 with degrees of freedom (1, 3152).||Test for group difference in the change from baseline to12-Months using linear contrast.||2.68|-1.44|0.5538
71922942|NCT03451630|143366519|SUPERIORITY|Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).||||||0.8505|||||||Mixed Models Analysis|F-statistics 0.44 with degrees of freedom (6, 3154).||Overall Test of the Group by Time Interaction||||0.8505
71922943|NCT03451630|143366519|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 16.97 with degrees of freedom (3, 3160).||Test for significant change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71922944|NCT03451630|143366519|SUPERIORITY|||||||0.8656||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.14 with degrees of freedom (2, 1229).||Test for significant change by treatment when the treatment-by-time interaction effect is not significant.||||0.8656
71922945|NCT03451630|143366519|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|1.29||0.474|TWO_SIDED|95.0|-1.61|3.46||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.51 with degrees of freedom (1, 3154)||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.46|-1.61|0.4740
71922946|NCT03451630|143366519|SUPERIORITY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|1.26||0.6017|TWO_SIDED|95.0|-1.81|3.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.27 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||3.13|-1.81|0.6017
71922947|NCT03451630|143366519|SUPERIORITY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.99||0.786|TWO_SIDED|95.0|-1.67|2.2||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (1, 3154).||Test for group difference in the change from baseline to 12-Months using the linear contrasts.||2.20|-1.67|0.7860
71922948|NCT03451630|143366520|SUPERIORITY|||||||0.59||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.59
71922949|NCT03451630|143366520|SUPERIORITY||Odds Ratio (OR)|1.26||||0.6692|TWO_SIDED|95.0|0.76|2.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||2.11|0.76|0.6692
71922950|NCT03451630|143366520|SUPERIORITY||Odds Ratio (OR)|1.16||||0.6692|TWO_SIDED|95.0|0.7|1.93||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.80 with degrees of freedom (2).||Test for the Treatment Effect||1.93|0.70|0.6692
71922951|NCT03451630|143366520|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6692|TWO_SIDED|95.0|0.75|1.59||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-square statistics 0.8 with degrees of freedom (2).||Test for the Treatment Effect||1.59|0.75|0.6692
71922952|NCT03451630|143366521|SUPERIORITY|||||||0.58||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.08 with degrees of freedom (2).||Overall Test of Marginal Group Differences||||0.58
71922953|NCT03451630|143366521|SUPERIORITY||Odds Ratio (OR)|1.13||||0.7436|TWO_SIDED|95.0|0.43|3.02||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect||3.02|0.43|0.7436
71922954|NCT03451630|143366521|SUPERIORITY||Odds Ratio (OR)|0.84||||0.7436|TWO_SIDED|95.0|0.31|2.25||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.25|0.31|0.7436
71922955|NCT03451630|143366521|SUPERIORITY||Odds Ratio (OR)|1.36||||0.7436|TWO_SIDED|95.0|0.62|2.97|||Regression, Logistic|Chi-squared statistics 0.59 with degrees of freedom (2).||Test for the treatment effect.||2.97|0.62|0.7436
71922956|NCT03451630|143366522|SUPERIORITY|||||||0.5558||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.82 with degrees of freedom (6, 3057)||Overall test of treatment-by-time interaction||||0.5558
71922957|NCT03451630|143366522|SUPERIORITY|||||||0.0002||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 6.74 with degrees of freedom (3, 3063).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0002
71922958|NCT03451630|143366522|SUPERIORITY|||||||0.7846||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.24 with degrees of freedom (2,1197).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.7846
71922959|NCT03451630|143366522|SUPERIORITY||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.61||0.2444|TWO_SIDED|95.0|-1.92|0.49||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-Statistics 1.36 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.49|-1.92|0.2444
71922960|NCT03451630|143366522|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.61||0.648|TWO_SIDED|95.0|-1.48|0.92||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.21 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.92|-1.48|0.6480
71922961|NCT03451630|143366522|SUPERIORITY||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.46||0.3476|TWO_SIDED|95.0|-1.34|0.47||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (1, 3057).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.47|-1.34|0.3476
71922962|NCT03451630|143366523|SUPERIORITY|||||||0.5199||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.86 with degrees of freedom (6, 3148)||Overall test of treatment-by-time||||0.5199
71922963|NCT03451630|143366523|SUPERIORITY|||||||0.0008||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.56 with degrees of freedom (3, 3154).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0008
71922964|NCT03451630|143366523|SUPERIORITY|||||||0.9897||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.01 with degrees of freedom (2,1229).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9897
71922965|NCT03451630|143366523|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.8749|TWO_SIDED|95.0|-0.03|0.03||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.03|-0.03|0.8749
71922966|NCT03451630|143366523|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.2216|TWO_SIDED|95.0|-0.05|0.01||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.49 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.01|-0.05|0.2216
71922967|NCT03451630|143366523|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.01||0.0607|TWO_SIDED|95.0|0.0|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.52 with degrees of freedom (1, 3148).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.04|0.00|0.0607
71922968|NCT03451630|143366524|SUPERIORITY|||||||0.1884||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.46 with degrees of freedom (6, 3138)||Overall test of treatment-by-time||||0.1884
71922969|NCT03451630|143366524|SUPERIORITY|||||||0.009||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.87 with degrees of freedom (3, 3144).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0090
71922970|NCT03451630|143366524|SUPERIORITY|||||||0.217||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.53 with degrees of freedom (2, 1227).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.2170
71922971|NCT03451630|143366524|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.09||0.191|TWO_SIDED|95.0|-0.06|0.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.71 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.28|-0.06|0.1910
71922972|NCT03451630|143366524|SUPERIORITY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.08||0.0229|TWO_SIDED|95.0|0.03|0.35||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 5.18 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.35|0.03|0.0229
71922973|NCT03451630|143366524|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.07||0.2547|TWO_SIDED|95.0|-0.21|0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.30 with degrees of freedom (1, 3138).||Test for Group difference in the change from baseline to 12 months using the linear contrasts.||0.06|-0.21|0.2547
71922974|NCT03451630|143366525|SUPERIORITY|||||||0.0413||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.49 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.0413
71922975|NCT03451630|143366525|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1433|TWO_SIDED|95.0|-0.28|0.04||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.14 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.04|-0.28|0.1433
71922976|NCT03451630|143366525|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4272|TWO_SIDED|95.0|-0.1|0.23||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.63 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.23|-0.10|0.4272
71922977|NCT03451630|143366525|SUPERIORITY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0037|TWO_SIDED|95.0|-0.31|-0.06||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 8.45 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||-0.06|-0.31|0.0037
71688772|NCT04633291|142892943|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.02|64.83||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||64.83|0.02|1.0
71922978|NCT03451630|143366526|SUPERIORITY|||||||0.8231||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.8231
71922979|NCT03451630|143366526|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 330.05 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71922980|NCT03451630|143366526|SUPERIORITY|||||||0.6061||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.50 with degrees of freedom (2 , 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.6061
71922981|NCT03451630|143366526|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.7459|TWO_SIDED|95.0|-0.15|0.11||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.11|-0.15|0.7459
71922982|NCT03451630|143366526|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.05||0.3169|TWO_SIDED|95.0|-0.18|0.08||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.00 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.08|-0.18|0.3169
71922983|NCT03451630|143366526|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.4098|TWO_SIDED|95.0|-0.07|0.14||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.68 with degrees of freedom (1, 3164).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.14|-0.07|0.4098
71922984|NCT03451630|143366527|SUPERIORITY|||||||0.4732||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.88 with degrees of freedom (4, 1945).||Overall test for the treatment-by-time interaction||||0.4732
71922985|NCT03451630|143366527|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 319.14 with degrees of freedom (2, 1948).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71922986|NCT03451630|143366527|SUPERIORITY|||||||0.9628||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (2, 1948).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9628
71922987|NCT03451630|143366527|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.07||0.8438|TWO_SIDED|95.0|-0.16|0.19||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.04 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.19|-0.16|0.8438
71922988|NCT03451630|143366527|SUPERIORITY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.7425|TWO_SIDED|95.0|-0.19|0.15||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.15|-0.19|0.7425
71922989|NCT03451630|143366527|SUPERIORITY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.06||0.5044|TWO_SIDED|95.0|-0.1|0.17||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.45 with degrees of freedom (1, 1945).||Test for Group difference in the change from baseline to 12-Months using the linear contrasts.||0.17|-0.10|0.5044
71922990|NCT03451630|143366528|SUPERIORITY|||||||0.9804||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9804
71688773|NCT04633291|142892944|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.08|12.87||The threshold for statistical significance was set at 0.05.|Regression, Logistic|Random effect: 'Subject'. Fixed effect: 'Visit' (Visit 1 and 2) and 'Treatment' (original coating and novel coating). Age was included as covariate.|OR=1 corresponds to exact equality. OR \>1 means that the investigational device is in favor compared to the comparator. OR \<1 means that the comparator device is in favor compared to the investigational device.|Null hypothesis: No difference between the devices.||12.87|0.08|1.0
71688774|NCT00076258|142892946|SUPERIORITY_OR_OTHER_LEGACY||Remission rate|29.5|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|Both unadjusted and adjusted rates (for significant covariates) were reported||||||<0.05
71922991|NCT03451630|143366528|SUPERIORITY||||||<|0.0001||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 21.80 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||<0.0001
71922992|NCT03451630|143366528|SUPERIORITY|||||||0.9764||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.02 with degrees of freedom (2, 1211).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.9764
71922993|NCT03451630|143366528|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9757|TWO_SIDED|95.0|0.63|1.6||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.03.||Odds ratio of Treatment at 12-Months||1.60|0.63|0.9757
71922994|NCT03451630|143366528|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7958|TWO_SIDED|95.0|0.67|1.68||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-test statistics 0.26.||Odds ratio of Treatment at 12-Months||1.68|0.67|0.7958
71922995|NCT03451630|143366528|SUPERIORITY||Odds Ratio (OR)|0.95||||0.7646|TWO_SIDED|95.0|0.67|1.34||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.30||Odds ratio of Treatment at 12-Months||1.34|0.67|0.7646
71922996|NCT03451630|143366529|SUPERIORITY|||||||0.9622||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.15 with degrees of freedom (4, 3164).||Overall test for the treatment-by-time interaction||||0.9622
71688775|NCT00076258|142892946|SUPERIORITY_OR_OTHER_LEGACY||Remission Rate|28.3|||<|0.05|TWO_SIDED||||||Generalized Linear Mixed Model|||For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p \< 0.06 and the NNT of 7.8 for the PHD versus the LD.||||<0.05
71688776|NCT00398216|142892969|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Fisher Exact|||||||0.003
71922997|NCT03451630|143366529|SUPERIORITY|||||||0.0377||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 3.28 with degrees of freedom (2, 3168).||Test for the change over time when the treatment-by-time interaction effect is not significant.||||0.0377
71922998|NCT03451630|143366529|SUPERIORITY|||||||0.83||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistic 0.19 with degrees of freedom (2, 1903).||Test for the change by treatment when the treatment-by-time interaction effect is not significant.||||0.8300
71688777|NCT00398216|142892969|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71688778|NCT00398216|142892969|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71688779|NCT00398216|142892969|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71688780|NCT00398216|142892972|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Fisher Exact|||||||.250
71688781|NCT00398216|142892972|SUPERIORITY_OR_OTHER|||||||0.122|TWO_SIDED||||||Fisher Exact|||||||.122
71688782|NCT00398216|142892972|SUPERIORITY_OR_OTHER|||||||0.124|TWO_SIDED||||||Fisher Exact|||||||.124
71688783|NCT00398216|142892972|SUPERIORITY_OR_OTHER|||||||0.123|TWO_SIDED||||||Fisher Exact|||||||.123
71688784|NCT01048944|142892973|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||P values are adjusted for multiple comparisons except for specific a priori directional predictions.|Mixed Models Analysis|||Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).||||<0.05
71922999|NCT03451630|143366529|SUPERIORITY||Odds Ratio (OR)|0.87||||0.7507|TWO_SIDED|95.0|0.38|2.0||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.32||Odds ratio of Treatment at 12-Months||2.00|0.38|0.7507
71923000|NCT03451630|143366529|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8844|TWO_SIDED|95.0|0.42|2.13||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.15||Odds ratio of Treatment at 12-Months||2.13|0.42|0.8844
71923001|NCT03451630|143366529|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8227|TWO_SIDED|95.0|0.49|1.77||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|T-statistics -0.22||Odds ratio of Treatment at 12-Months||1.77|0.49|0.8227
71923002|NCT03451630|143366530|OTHER|||||||1|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1a||||1.00
71923003|NCT03451630|143366530|OTHER|||||||0.242|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Frequency and test of the marginal association between event rate and treatment for eligible participants' data at 12 months for MMA-1b||||0.242
71923004|NCT03451630|143366531|OTHER|||||||0.1112|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-1||||0.1112
71923005|NCT03451630|143366531|OTHER|||||||0.4754|||||||Fisher Exact|Fisher's exact test for the null hypothesis of no association between each event and treatment group.||Test of the marginal association between event rate and treatment for eligible participants' data at 12 months for PCE-2||||0.4754
71923006|NCT03451630|143366532|SUPERIORITY||Odds Ratio (OR)|0.74||||0.9079|TWO_SIDED|95.0|0.13|4.28||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||4.28|0.13|0.9079
71923007|NCT03451630|143366532|SUPERIORITY||Odds Ratio (OR)|0.68||||0.9079|TWO_SIDED|95.0|0.13|3.72||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.72|0.13|0.9079
71923008|NCT03451630|143366532|SUPERIORITY||Odds Ratio (OR)|1.08||||0.9079|TWO_SIDED|95.0|0.34|3.45||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Regression, Logistic|Chi-squared statistics 0.19 with degrees of freedom (2).||Test for the treatment effect (without weight) using a Firth's penalized logistic regression model for rare events.||3.45|0.34|0.9079
71923009|NCT03451630|143366533|SUPERIORITY|||||||0.9912||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.07 with degrees of freedom (4, 335).||Test for the treatment-by-time interaction (without weight) for SPC-1.||||0.9912
71923010|NCT03451630|143366533|SUPERIORITY|||||||0.876||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 339).||Test for change over time for SPC-1||||0.8760
71923011|NCT03451630|143366533|SUPERIORITY|||||||0.678||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.39 with degrees of freedom (2, 276).||Test for change in treatment effect for SPC-1||||0.6780
71923012|NCT03451630|143366533|SUPERIORITY|||||||0.1761||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.59 with degrees of freedom (4, 284).||Test for the treatment-by-time interaction (without weight) for SPC-2||||0.1761
71923013|NCT03451630|143366533|SUPERIORITY|||||||0.3239||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.13 with degrees of freedom (2, 288).||Test for change over time for SPC-2||||0.3239
71923014|NCT03451630|143366533|SUPERIORITY|||||||0.7415||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.30 with degrees of freedom (2, 139).||Test for change in treatment effect for SPC-2||||0.7415
71923015|NCT03451630|143366534|SUPERIORITY|||||||0.9786||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.11 with degrees of freedom (4, 608).||Test for the treatment-by-time interaction (without weight) for SPD-1.||||0.9786
71923016|NCT03451630|143366534|SUPERIORITY|||||||0.4703||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.76 with degrees of freedom (2, 612).||Test for change over time for SPD-1||||0.4703
71923017|NCT03451630|143366534|SUPERIORITY|||||||0.877||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.13 with degrees of freedom (2, 332).||Test for change in treatment effect for SPD-1||||0.8770
71923018|NCT03451630|143366534|SUPERIORITY|||||||0.6198||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.66 with degrees of freedom (4, 469).||Test for the treatment-by-time interaction (without weight) for SPD-2||||0.6198
71923019|NCT03451630|143366534|SUPERIORITY|||||||0.6211||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.48 with degrees of freedom (2, 473).||Test for change over time for SPD-2||||0.6211
71923020|NCT03451630|143366534|SUPERIORITY|||||||0.1471||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.93 with degrees of freedom (2, 219).||Test for change in treatment effect for SPD-2.||||0.1471
71688785|NCT02207400|142892978|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-11.612|||<|0.0001|TWO_SIDED|95.0|-13.191|-10.033|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-10.033|-13.191|<0.0001
71923021|NCT03451630|143366535|SUPERIORITY|||||||0.8247||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.38 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-1||||0.8247
71923022|NCT03451630|143366535|SUPERIORITY|||||||0.6651||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.41 with degrees of freedom (2, 284).||Test for change over time for AMM-1||||0.6651
71923023|NCT03451630|143366535|SUPERIORITY|||||||0.3441||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 1.07 with degrees of freedom (2, 218).||Test for change in treatment effect for AMM-1||||0.3441
71923024|NCT03451630|143366535|SUPERIORITY|||||||0.0847||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 2.07 with degrees of freedom (4, 280).||Test for the treatment-by-time interaction (without weight) for AMM-2||||0.0847
71923025|NCT03451630|143366535|SUPERIORITY|||||||0.9695||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.03 with degrees of freedom (2, 284).||Test for change over time for AMM-2||||0.9695
71923026|NCT03451630|143366535|SUPERIORITY|||||||0.9396||||||Controlling for: age, sex, race, ethnicity, insurance, engagement at baseline, comfortability with technology, tech literacy (HINTS), social support at baseline (ISEL), health literacy (AAHLS), illness burden (CCI), and area deprivation index (ADI).|Mixed Models Analysis|F-statistics 0.06 with degrees of freedom (2, 200).||Test for change in treatment effect for AMM-2||||0.9396
71923027|NCT03503617|143366536|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71923028|NCT02452892|143366544|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.307||||||"P-value displayed for 60min.~Mixed Model Repeated Measures (MMRM) model."|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.307
71923029|NCT02452892|143366544|SUPERIORITY|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p\<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.859||||||P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.||Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS \& sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.||||0.859
71923030|NCT02452892|143366545|SUPERIORITY|||||||0.966||||||P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 2 baseline HAM-D6 total score, treatment, visit, treatment\*visit, age, \& gender included in model. Visit was the repeated measure within subject.||||||0.966
71923031|NCT02452892|143366546|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.294||||||For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.294
71923032|NCT02452892|143366546|SUPERIORITY|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.232||||||For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response||||||0.232
71923033|NCT02452892|143366547|SUPERIORITY|||||||0.0932||||||P-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.0932
71923034|NCT02452892|143366547|SUPERIORITY|||||||0.7509||||||The p-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.||||0.7509
71923035|NCT02452892|143366548|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.2672||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.2672
71923036|NCT02452892|143366548|SUPERIORITY|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.166||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.||||||0.1660
71923037|NCT02452892|143366549|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~* All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~* The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~* The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
71923038|NCT02452892|143366549|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3537||||||"P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.~."|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3537
71923039|NCT02452892|143366550|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0848||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0848
71923040|NCT02452892|143366550|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.593||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.5930
71923041|NCT02452892|143366551|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.0307
71923042|NCT02452892|143366551|SUPERIORITY|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3907||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed \& the negative score for affected subjects \& visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."||||0.3907
71923043|NCT02041533|143366607|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.15||||0.2511|TWO_SIDED|95.0|0.91|1.45|||Log Rank|Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.|Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.45|0.91|0.2511
71923044|NCT02041533|143366608|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.17|||||TWO_SIDED|95.0|0.95|1.43|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.43|0.95|
71923045|NCT02041533|143366609|SUPERIORITY||Hazard Ratio (HR)|0.97|||||TWO_SIDED|95.0|0.79|1.2|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.20|0.79|
71923046|NCT02041533|143366610|SUPERIORITY||Hazard Ratio (HR)|1.03|||||TWO_SIDED|95.0|0.86|1.24|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.|||1.24|0.86|
71923047|NCT02041533|143366611|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.06|||||Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.|||1.06|0.46|
71923048|NCT02117024|143366613|SUPERIORITY|||||||0.0011|||||||Log Rank|||||||0.0011
71923049|NCT02117024|143366613|OTHER||Hazard Ratio (HR)|1.0|||<|0.05|TWO_SIDED||||||Other|||With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.||||<0.05
71923050|NCT02500706|143366655|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|-0.02|||<|0.001|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|<0.001
71923051|NCT02500706|143366655|NON_INFERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|0.1|||<|0.001|TWO_SIDED|95.0|0.004|0.19||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.19|0.004|<0.001
71923052|NCT02500706|143366655|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points."|Treatment difference|-0.02||||0.633|TWO_SIDED|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.||0.07|-0.11|0.633
71923053|NCT02500706|143366656|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.~Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0."|Treatment difference|-0.9|||<|0.001|TWO_SIDED|95.0|-1.36|-0.45||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA|||Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.||-0.45|-1.36|<0.001
71923054|NCT02500706|143366657|SUPERIORITY|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0."|Treatment difference|0.02||||0.924|TWO_SIDED|95.0|-0.31|0.34||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.||0.34|-0.31|0.924
71923055|NCT00529152|143366705|SUPERIORITY_OR_OTHER|||||||0.0005|||||||Regression, Linear|||Change in Serum Ferritin from baseline to week 24 was compared using regression analysis; null hypothesis was defined as no change in serum ferritin from baseline to week 24||||0.0005
71923056|NCT01497899|143366721|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.|Difference in percentages|-2.9||||0.58|TWO_SIDED|95.0|-13.5|7.7|||Cochran-Mantel-Haenszel|P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.|Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|||7.7|-13.5|0.58
71923057|NCT01680835|143366725|OTHER|Freedom from primary safety composite event at 36 months compared to a performance goal of 35%|Kaplan Meier|0.771|||<|0.001|ONE_SIDED|97.5|0.678||||Log Rank||||||0.678|<0.001
71923058|NCT01680835|143366726|OTHER|No hypothesis Testing for this endpoint.|Kaplan Meier|1.0|STANDARD_ERROR_OF_MEAN|0.0|||TWO_SIDED|||||||||Stent Fracture at 1 Year||||
71923059|NCT01680835|143366726|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.989|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Stent Fracture at 2 Years||||
71923060|NCT01680835|143366726|OTHER|No hypothesis testing was done for this endpoint|Kaplan Meier|0.965|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|||||||||Stent Fracture at 3 Years||||
71923061|NCT01680835|143366727|OTHER|No hypothesis testing was done at this endpoint|Kaplan Meier|0.86|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year||||
71923062|NCT01680835|143366727|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.782|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years||||
71923063|NCT01680835|143366728|OTHER|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.99|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|||||||||Estimate from freedom from major amputation through 3 years.||||
71923064|NCT01680835|143366729|OTHER||Kaplan Meier|0.781|STANDARD_ERROR_OF_MEAN|0.04|||TWO_SIDED|||||||||Freedom from clinically-driven TLR through 3 Years||||
71923065|NCT05047601|143366736|SUPERIORITY||Risk Ratio (RR)|0.702||||0.1722|TWO_SIDED|95.0|0.422|1.167|||Generalized estimating equation (GEE)|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.167|0.422|0.1722
71923066|NCT05047601|143366736|SUPERIORITY||Risk Ratio (RR)|0.645||||0.1163|TWO_SIDED|95.0|0.373|1.115|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.115|0.373|0.1163
71923067|NCT05047601|143366738|SUPERIORITY||Risk Ratio (RR)|0.88||||0.6766|TWO_SIDED|95.0|0.484|1.602|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.602|0.484|0.6766
71923068|NCT05047601|143366738|SUPERIORITY||Risk Ratio (RR)|0.809||||0.507|TWO_SIDED|95.0|0.433|1.512|||GEE|Model included the fixed effects of treatment, geographic regions. Compound symmetry variance-covariance structure.||||1.512|0.433|0.5070
71923069|NCT05047601|143366740|SUPERIORITY||Risk Ratio (RR)|0.672||||0.1869|TWO_SIDED|95.0|0.373|1.213|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.213|0.373|0.1869
71923070|NCT05047601|143366740|SUPERIORITY||Risk Ratio (RR)|0.633||||0.1221|TWO_SIDED|95.0|0.355|1.13|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.130|0.355|0.1221
71923071|NCT05047601|143366741|SUPERIORITY|||||||0.0368|||||||Log Rank|||||||0.0368
71923072|NCT05047601|143366741|SUPERIORITY|||||||0.0186|||||||Log Rank|||||||0.0186
71923073|NCT05047601|143366742|SUPERIORITY||Risk Ratio (RR)|0.75||||0.4126|TWO_SIDED|95.0|0.378|1.491|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.491|0.378|0.4126
71923074|NCT05047601|143366742|SUPERIORITY||Risk Ratio (RR)|1.244||||0.4273|TWO_SIDED|95.0|0.725|2.135|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||2.135|0.725|0.4273
71923075|NCT05047601|143366743|SUPERIORITY||Risk Ratio (RR)|0.726||||0.1333|TWO_SIDED|95.0|0.478|1.103|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.103|0.478|0.1333
71923076|NCT05047601|143366743|SUPERIORITY||Risk Ratio (RR)|0.953||||0.8088|TWO_SIDED|95.0|0.645|1.408|||GEE|Model included the fixed effects of treatment, geographic regions and presence of risk factors. Compound symmetry variance-covariance structure.||||1.408|0.645|0.8088
71923077|NCT05047601|143366751|SUPERIORITY||LS Mean Ratio|0.969||||0.7991|TWO_SIDED|95.0|0.758|1.238|||Negative binomial regression model|||||1.238|0.758|0.7991
71923078|NCT05047601|143366751|SUPERIORITY||LS Mean Ratio|0.847||||0.1985|TWO_SIDED|95.0|0.657|1.091|||Negative binomial regression model|||||1.091|0.657|0.1985
71923079|NCT03137173|143366754|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% confidence interval (CI) of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the Cochran-Mantel-Haenszel (CMH) weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|3.3|||||TWO_SIDED|95.0|-1.2|7.8||||||||7.8|-1.2|
71923080|NCT03137173|143366755|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|1.0|||||TWO_SIDED|95.0|-3.5|5.6||||||||5.6|-3.5|
71923081|NCT03137173|143366756|NON_INFERIORITY|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin plus aztreonam) using a 10% non-inferiority margin in the CE populations. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|2.7|||||TWO_SIDED|95.0|-0.3|5.6||||||||5.6|-0.3|
71923082|NCT02828982|143366759|SUPERIORITY|||||||0.585||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there would be no difference in metabolic costs between the two groups||||0.585
71923083|NCT02828982|143366760|SUPERIORITY|||||||0.452||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||The null hypothesis was that there were no differences in the number of steps taken outside of the home for the two prostheses.||||0.452
71923084|NCT02828982|143366761|OTHER|paired t-test of Physical component scores between the two conditions||||||0.48||||||a prior threshold for significance was 0.05|t-test, 2 sided|||||||0.480
71923085|NCT02828982|143366761|SUPERIORITY|||||||0.408||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||Mental Component Score||||0.408
71923086|NCT02828982|143366762|SUPERIORITY|||||||0.058||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Ambulation Score||||0.058
71923087|NCT02828982|143366762|OTHER|paired t-test between conditions||||||0.123||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Appearance Score||||.123
71923088|NCT02828982|143366762|OTHER|paired t-test between conditions||||||0.052||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Frustration Score||||.052
71923089|NCT02828982|143366762|OTHER|paired t-test between conditions||||||0.188||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Perceived Response Score||||.188
71923090|NCT02828982|143366762|OTHER|paired t-test between conditions||||||0.336||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Limb Health Score||||.336
71923091|NCT02828982|143366762|OTHER|paired t-test between conditions||||||0.043||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Social Burden Score||||.043
71923092|NCT02828982|143366762|OTHER|paired t-test between conditions||||||0.391||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Sounds Score||||.391
71923093|NCT02828982|143366762|SUPERIORITY|paired t-test between conditions||||||0.799||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Utility Score||||.799
71923094|NCT02828982|143366762|SUPERIORITY|||||||0.173||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Well-Being||||.173
71923095|NCT02828982|143366763|OTHER|paired t-test between conditions||||||0.655||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Biceps Femoris||||0.655
71923096|NCT02828982|143366763|OTHER|paired t-test between conditions||||||0.281||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Rectus Femoris||||.281
71923097|NCT02828982|143366763|OTHER|paired t-test between conditions||||||0.844||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Soleus||||.844
71923098|NCT02828982|143366763|OTHER|paired t-test between conditions||||||0.11||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Intact Side Tibialis Anterior||||.110
71923099|NCT02828982|143366763|OTHER|paired t-test between conditions||||||0.394||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Biceps Femoris||||.394
71923100|NCT02828982|143366763|SUPERIORITY|||||||0.141||||||Statistical significance was set a-priori at p\<0.05.|t-test, 2 sided|||Residual Side Rectus Femoris||||.141
71923101|NCT02828982|143366764|SUPERIORITY|||||||0.212||||||Statistical significance was set a-priori at p\<0.05|t-test, 2 sided|||||||0.212
71923102|NCT00911508|143366785|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.65|1.15||||||||1.15|0.65|
71923103|NCT00911508|143366786|SUPERIORITY||Cox Proportional Hazard|0.85|||||TWO_SIDED|95.0|0.6|1.21||||||||1.21|0.60|
71923104|NCT00911508|143366787|SUPERIORITY||Cox Proportional Hazard|0.83|||||TWO_SIDED|95.0|0.74|0.93||||||||0.93|0.74|
71923105|NCT00911508|143366788|SUPERIORITY||Cox Proportional Hazard|0.88|||||TWO_SIDED|95.0|0.72|1.09||||||||1.09|0.72|
71923106|NCT00911508|143366789|SUPERIORITY||Cox Proportional Hazard|0.94|||||TWO_SIDED|95.0|0.53|1.68||||||||1.68|0.53|
71923107|NCT00911508|143366790|SUPERIORITY||Cox Proportional Hazard|0.87|||||TWO_SIDED|95.0|0.51|1.51||||||||1.51|0.51|
71923108|NCT00911508|143366791|SUPERIORITY||Cox Proportional Hazard|0.76|||||TWO_SIDED|95.0|0.33|1.72||||||||1.72|0.33|
71923109|NCT00911508|143366792|SUPERIORITY||Cox Proportional Hazard|1.13|||||TWO_SIDED|95.0|0.41|3.09||||||||3.09|0.41|
71923110|NCT00911508|143366793|SUPERIORITY||Cox Proportional Hazard|0.52|||||TWO_SIDED|95.0|0.45|0.6||||||||0.60|0.45|
71923111|NCT00911508|143366794|SUPERIORITY||Cox Proportional Hazard|0.86|||||TWO_SIDED|95.0|0.77|0.97||||||||0.97|0.77|
71923112|NCT00911508|143366795|SUPERIORITY||Mean Difference (Net)|5.3|||<|0.001|TWO_SIDED|95.0|3.7|6.9|||Mixed Models Analysis|||12 Month||6.9|3.7|<0.001
71923113|NCT00911508|143366795|SUPERIORITY||Mean Difference (Net)|3.4|||<|0.001|TWO_SIDED|95.0|2.1|4.8|||Mixed Models Analysis|||5 Years||4.8|2.1|<0.001
71923114|NCT00911508|143366796|SUPERIORITY||Mean Difference (Net)|-1.7||||0.001|TWO_SIDED|95.0|-2.3|-1.2|||Mixed Models Analysis|||12 Month||-1.2|-2.3|0.001
71923115|NCT00911508|143366796|SUPERIORITY||Mean Difference (Net)|-1.4||||0.001|TWO_SIDED|95.0|-1.9|-0.9|||Mixed Models Analysis|||5 Year||-0.9|-1.9|0.001
71923116|NCT00911508|143366797|SUPERIORITY||Mean Difference (Net)|-1.5|||<|0.001|TWO_SIDED|95.0|-2.0|-1.1|||Mixed Models Analysis|||12 Month||-1.1|-2.0|<0.001
71923117|NCT00911508|143366797|SUPERIORITY||Mean Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.7|-0.4|||Mixed Models Analysis|||5 Year||-0.4|-1.7|<0.001
71923118|NCT01409382|143366801|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.4|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|1.5|7.6|||Chi-squared|||Take home babies||7.6|1.5|<0.05
71923119|NCT02058940|143366831|OTHER|||||||0.2|||||||Spearman's Correlation Coefficient|||||||0.2
71923120|NCT01519700|143366836|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)|Mean Difference (Net)|0.04|||||ONE_SIDED|97.5|-0.26||||||The one-sided 97.5% Confidence Interval: \[-0.26, ∞).||||-0.26|
71923121|NCT01789476|143366853|SUPERIORITY_OR_OTHER||||||<|0.05||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.05
71923122|NCT01789476|143366854|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
71923123|NCT01789476|143366855|SUPERIORITY_OR_OTHER||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA|||||||<0.03
71923124|NCT00965458|143366856|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.||||0.065
71923125|NCT00965458|143366857|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.019
71923126|NCT00965458|143366857|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.002
71923127|NCT00965458|143366858|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.065
71923128|NCT00965458|143366858|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL||||0.015
71923129|NCT00965458|143366859|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean insulin use comparison||||0.020
71923130|NCT00965458|143366859|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean insulin use comparison||||0.002
71923131|NCT00965458|143366860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Baseline to Week 52||||<0.001
71923132|NCT00965458|143366860|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Week 52 to Week 104||||<0.001
71923133|NCT00965458|143366861|SUPERIORITY_OR_OTHER|||||||0.746|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean HbA1C comparison||||0.746
71923134|NCT00965458|143366861|SUPERIORITY_OR_OTHER|||||||0.942|TWO_SIDED|||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean HbA1C comparison||||0.942
71923135|NCT00692198|143366882|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.52|TWO_SIDED|95.0|0.79|1.12|||Log Rank|||||1.12|0.79|0.52
71923136|NCT00692198|143366883|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.53|TWO_SIDED|95.0|0.64|1.25|||Log Rank||Hazard ratio, LTOT vs No LTOT|||1.25|0.64|0.53
71923137|NCT00692198|143366884|SUPERIORITY_OR_OTHER||Rate ratio|1.01||||0.81|TWO_SIDED|95.0|0.91|1.13|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.13|0.91|0.81
71923138|NCT00692198|143366886|SUPERIORITY_OR_OTHER||Rate ratio|1.08||||0.12|TWO_SIDED|95.0|0.98|1.19|||Fisher Exact||Rate ratio, LTOT vs No LTOT|||1.19|0.98|0.12
71923139|NCT00692198|143366887|SUPERIORITY_OR_OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71923140|NCT00692198|143366888|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71923141|NCT00692198|143366889|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71923142|NCT00692198|143366890|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||||||0.03
71923143|NCT00692198|143366891|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71923144|NCT00692198|143366892|SUPERIORITY_OR_OTHER|||||||0.41|||||||t-test, 2 sided|||||||0.41
71923145|NCT00692198|143366893|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.09|||||TWO_SIDED|95.0|0.54|8.0|||||Relative risk, LTOT vs No LTOT|||8.00|0.54|
71923146|NCT00692198|143366894|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
71923147|NCT00692198|143366895|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71923148|NCT03039686|143366899|SUPERIORITY||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.87|||TWO_SIDED|95.0|-2.17|1.27|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age Interactive response system (IXRS) Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||1.27|-2.17|
71923149|NCT03039686|143366899|SUPERIORITY||Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|95.0|-1.1|2.26|||||Based on the MMRM using an unstructured covariance matrix -change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.26|-1.10|
71923150|NCT03039686|143366901|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.21|0.2|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.20|-0.21|
71923151|NCT03039686|143366901|SUPERIORITY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.12|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.12|
71923152|NCT03039686|143366903|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
71923153|NCT03039686|143366903|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|0.0|0.06|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.06|-0.00|
71923154|NCT03039686|143366905|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.08|0.27|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.27|-0.08|
71923155|NCT03039686|143366905|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.17|0.18|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||0.18|-0.17|
71923156|NCT03039686|143366907|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|2.41|||TWO_SIDED|95.0|-6.76|2.77|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||2.77|-6.76|
71923157|NCT03039686|143366907|SUPERIORITY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.36|||TWO_SIDED|95.0|-3.71|5.63|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||5.63|-3.71|
71923158|NCT03039686|143366910|SUPERIORITY||Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|11.5|||TWO_SIDED|95.0|-21.1|24.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||24.6|-21.1|
71923159|NCT03039686|143366910|SUPERIORITY||Mean Difference (Final Values)|11.3|STANDARD_ERROR_OF_MEAN|11.3|||TWO_SIDED|95.0|-11.0|33.6|||||Based on the MMRM using an unstructured covariance matrix - change = Baseline + Age IXRS Stratum + Corticosteroid Regimen IXRS Stratum + Analysis Visit\*Treatment.|||33.6|-11.0|
71923160|NCT04250558|143366921|OTHER|||||||0.05|||||||Regression, Logistic|||Kinetic parameters were assessed by Mann-Whitney U test in MATLAB Statistics and Machine Learning Toolbox. Receiver operating characteristic (ROC) analysis based on logistic regression was utilized, with one surgical condition versus the other two states as the binary dependent variable, and each perfusion-related kinetic parameter of Imax, IS and BF as the independent variable. Power analysis was performed to evaluate the statistical validity, using G\*Power software||||0.05
71923161|NCT00772031|143366924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.97||0.77|TWO_SIDED|95.0|-1.8|2.4|||ANCOVA|covariate adjustments: study site, baseline mod-to-sev 28-day headache-rate, topiramate use, medication overuse, and anti-depressive medications use.|Topiramate plus placebo mean reduction minus topiramate plus propranolol reduction|The study was designed to enroll 250 subjects to provide at least 90% power to detect a 3-day difference and 87% power to detect a 2.5-day difference in 28-day moderate-to-severe headache rate reductions at six months, assuming a type I error rate of 0.05, a two-sided test, a 10% loss to follow-up and a standard deviation of within-person change in days with headache of six.||2.4|-1.8|0.77
71923162|NCT00772031|143366925|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44|||||TWO_SIDED|95.0|0.75|2.78||||||||2.78|0.75|
71923163|NCT00772031|143366926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.5|2.02||||||||2.02|0.50|
71923164|NCT00772031|143366928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28|STANDARD_DEVIATION|3.75||0.91||95.0|||||ANCOVA|||||||0.91
71923165|NCT00656136|143366932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.077||||0.7428|TWO_SIDED|95.0|0.862|1.346||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.||1.346|0.862|0.7428
71923166|NCT00656136|143366932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.976||||0.3955|TWO_SIDED|95.0|0.814|1.17||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.||1.170|0.814|0.3955
71923167|NCT00656136|143366933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.381|||<|0.0001|TWO_SIDED|95.0|0.306|0.475||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||0.475|0.306|<0.0001
71923168|NCT00656136|143366934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|15.61||||0.0071|TWO_SIDED|95.0|2.1|115.0||P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)|Regression, Logistic|Model stratified by gender and baseline ECOG score (0,1 vs 2)||||115|2.1|0.0071
71923169|NCT01101321|143366964|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||TWO_SIDED|90.0|96.14|104.96|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||104.96|96.14|
71923170|NCT01101321|143366965|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.44|101.73|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.73|95.44|
71923171|NCT01101321|143366966|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||TWO_SIDED|90.0|95.42|101.7|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||101.70|95.42|
71923172|NCT01098266|143366977|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.58|TWO_SIDED|95.0|0.75|1.18||The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.|Log Rank|Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.||Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05||1.18|0.75|0.58
71923173|NCT01098266|143366978|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.65|TWO_SIDED|95.0|0.78|1.17|||Log Rank|Cox regression analyses (unstratified and stratified) was performed to assess the influence of baseline covariates in an exploratory manner.||The log-rank test (unstratified and stratified) was used at an alpha level of 5% to test for differences in PFS between the two treatment arms. Kaplan-Meier curves and estimates were provided.||1.17|0.78|0.65
71923174|NCT01098266|143366979|SUPERIORITY||Odds Ratio (OR)|1.13||||0.62|TWO_SIDED|95.0|0.76|1.68|||Fisher Exact||Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner|Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.||1.68|0.76|0.62
71923175|NCT01098266|143366982|OTHER|Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.|Hazard Ratio (HR)|0.92||||0.5806|TWO_SIDED|95.0|0.68|1.26|||Log Rank|||QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.||1.26|0.68|0.5806
71923176|NCT01733758|143367000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.55|||||TWO_SIDED|95.0|-1.72|-1.39|||ANCOVA|||||-1.39|-1.72|
71923177|NCT01733758|143367000|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.35|||||TWO_SIDED|95.0|-1.51|-1.18|||ANCOVA|||||-1.18|-1.51|
71688786|NCT02207400|142892979|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.652|||<|0.0001|TWO_SIDED|95.0|-0.738|-0.566|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.|||-0.566|-0.738|<0.0001
71688787|NCT02362425|142893008|SUPERIORITY|An a priori power calculation, with power at 80% and a two-sided α of 0·05, determined that n=76 participants (n=38 per group) would be required to detect a statistically significant post-intervention difference in plasma glutathione (GSH) concentration between NAC and placebo groups. After the primary endpoint was changed, re-evaluation of the sample size determined that a larger sample (total n=182) would be required. As per protocol, the study was completed at this time.|Mean Difference (Final Values)|0.1||||0.88|TWO_SIDED|95.0|-1.4|1.6|||Regression, Linear|Model comparing 12 m corrected 15-F2t-isoprostane conc. controlling for pre-intervention value. Investigated covariates: smoking and drinking status.||Null Hypothesis: In RYR1-RM myopathy patients, there will be no statistically significant difference in corrected 15-F2t-isoprostane concentration and/or corrected 15=f2t-Isop:PGR2alpha ratio between NAC and placebo groups at month 12, after controlling for established a priori confounders.||1.6|-1.4|0.88
71688788|NCT02362425|142893009|SUPERIORITY||Mean Difference (Final Values)|23.9||||0.11|TWO_SIDED|95.0|-5.5|53.4||Model controlled for six-month(pre-intervention) distance and treatment group. Investigated covariates: height|Regression, Linear|||In RYR1-RM myopathy patients, there will be no statistically significant difference in 6MWT (six minute walk test) total distance between NAC and placebo groups at month 12, after controlling for established a priori confounders.||53.4|-5.5|.11
71688789|NCT02362425|142893010|SUPERIORITY||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-3.6|0.7|||Regression, Linear|||||0.7|-3.6|0.14
71688790|NCT02362425|142893011|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.62|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||||0.3|-0.5|0.62
71688791|NCT02362425|142893012|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.05|TWO_SIDED|95.0|-1.1|0.0|||t-test, 2 sided|||||0.0|-1.1|0.05
71688792|NCT02362425|142893013|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.1|0.6|||t-test, 2 sided|||||0.6|-2.1|0.25
71923178|NCT01733758|143367000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg - placebo) is equal to zero.||||||<0.0001
71923179|NCT01733758|143367000|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg - placebo) is equal to zero.||||||<0.0001
71688793|NCT02362425|142893014|SUPERIORITY||Mean Difference (Final Values)|-1.1||||0.05|TWO_SIDED|95.0|-2.1|0.0|||t-test, 2 sided|||||0.0|-2.1|0.05
71688794|NCT02362425|142893015|SUPERIORITY||Mean Difference (Final Values)|3.4||||0.09|TWO_SIDED|95.0|-0.6|7.3|||t-test, 2 sided|||||7.3|-0.6|0.09
71923180|NCT01111058|143367011|SUPERIORITY||Difference in survival proportions|0.0022||||0.9|TWO_SIDED|95.0|-0.33|0.33|||Comparison of Kaplan-Meier estimates|Used Greenwood standard errors||||0.33|-0.33|0.90
71923181|NCT01111058|143367011|SUPERIORITY|||||||0.54|||||||Log Rank|||||||0.54
71923182|NCT01111058|143367012|SUPERIORITY|||||||0.086|||||||Fisher Exact|||||||0.086
71923183|NCT02790476|143367022|SUPERIORITY||Mean Difference (Final Values)|-27.8|||<|0.05|TWO_SIDED|95.0|-38.2|-17.63||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (288.36-347.65 = -59.29) and control (318.60-350.09 = -31.49) arms, resulting in a difference of -27.80.|1-3 months post intervention||-17.63|-38.20|<0.05
71688795|NCT02362425|142893016|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.69|TWO_SIDED|95.0|-1.3|2.0|||t-test, 2 sided|||||2.0|-1.3|0.69
71688796|NCT02362425|142893017|SUPERIORITY||Mean Difference (Final Values)|-1.2||||0.31|TWO_SIDED|95.0|-3.5|1.1|||t-test, 2 sided|||||1.1|-3.5|0.31
71688797|NCT02362425|142893018|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.22|TWO_SIDED|95.0|-0.8|3.0|||t-test, 2 sided|||||3.0|-0.8|0.22
71688798|NCT02362425|142893019|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.93|TWO_SIDED|95.0|-2.6|2.4|||t-test, 2 sided|||||2.4|-2.6|0.93
71688799|NCT02362425|142893020|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.66|TWO_SIDED|95.0|-1.3|0.8|||t-test, 2 sided|||||0.8|-1.3|0.66
71688800|NCT02362425|142893021|SUPERIORITY||Mean Difference (Final Values)|2.1||||0.09|TWO_SIDED|95.0|-0.4|4.6|||t-test, 2 sided|||||4.6|-0.4|0.09
71688801|NCT02362425|142893022|SUPERIORITY||Mean Difference (Final Values)|4.2||||0.09|TWO_SIDED|95.0|-0.7|9.0|||t-test, 2 sided|||||9.0|-0.7|0.09
71688802|NCT02362425|142893023|SUPERIORITY||Mean Difference (Final Values)|-5.5||||0.15|TWO_SIDED|95.0|-13.4|2.4|||t-test, 2 sided|||||2.4|-13.4|0.15
71688803|NCT02362425|142893024|SUPERIORITY||Mean Difference (Final Values)|-6.4||||0.08|TWO_SIDED|95.0|-13.7|1.0|||t-test, 2 sided|||||1.0|-13.7|0.08
71688804|NCT02362425|142893025|SUPERIORITY||Mean Difference (Final Values)|-16.27||||0.39|TWO_SIDED|95.0|-80.1|47.5|||t-test, 2 sided|||||47.5|-80.1|0.39
71688805|NCT02362425|142893026|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.57|TWO_SIDED|95.0|-59.5|39.5|||t-test, 2 sided|||||39.5|-59.5|0.57
71923184|NCT02790476|143367022|SUPERIORITY||Mean Difference (Final Values)|-12.42|||<|0.01|TWO_SIDED|95.0|-18.4|-6.55||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (167.83-347.65 = -179.83) and control (182.67-350.09 = -167.41) arms, resulting in a difference of -12.42.|||-6.55|-18.40|<0.01
71923185|NCT02790476|143367023|SUPERIORITY||Mean Difference (Final Values)|-0.35||||0.224|TWO_SIDED|95.0|-0.92|0.22||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.45-3.74 = -0.29) and control (3.45-4.59= -0.64) arms, resulting in a difference of -0.35.|Change in mean number of =\> 50 MME prescriptions pre- to 1-3 months post-intervention||0.22|-0.92|0.224
71923186|NCT02790476|143367023|SUPERIORITY||Mean Difference (Final Values)|-0.7|||<|0.001|TWO_SIDED|95.0|-1.08|-0.33||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (3.00-3.74 = -0.74) and control (3.15-4.59= -1.44) arms, resulting in a difference of -0.70.|Change in mean number of =\> 50 MME prescriptions pre- to 4-12 months post-intervention||-0.33|-1.08|<0.001
71923187|NCT02790476|143367023|SUPERIORITY||Mean Difference (Final Values)|-0.21||||0.279|TWO_SIDED|95.0|-0.59|0.17||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.00-2.14 = -0.14) and control (2.20-2.55= -0.35) arms, resulting in a difference of -0.21.|Change in mean number of \> 90 MME prescriptions pre- to 1-3 months post-intervention||0.17|-0.59|0.279
71923188|NCT02790476|143367023|SUPERIORITY||Mean Difference (Final Values)|-0.38|||<|0.01|TWO_SIDED|95.0|-0.63|-0.12||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (1.71-2.14 = -0.43) and control (1.74-2.55= -0.81) arms, resulting in a difference of -0.38.|Change in mean number of \> 90 MME prescriptions pre- to 4-12 months post-intervention||-0.12|-0.63|<0.01
71923189|NCT02790476|143367024|SUPERIORITY||Mean Difference (Final Values)|-1.6|||<|0.05|TWO_SIDED|95.0|-3.2|-0.1||The threshold for statistical significance was p=0.05.|Mixed Models Analysis|Pre-intervention values were trimmed at 95% with bootstrapped means and confidence intervals.|This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean DME in the letter (72.3-76 = -3.7) and control (82-82.9 = -0.9) arms, resulting in a difference of -1.6.|||-0.1|-3.2|<0.05
71923190|NCT02790476|143367026|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.823|TWO_SIDED|95.0|-0.23|0.29||The threshold for statistical significance was p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.44-3.72 = -1.28) and control (2.26-3.51= -1.25) arms, resulting in a difference of 0.03.|Change in mean number of new patients pre- to 1-3 months post-intervention||0.29|-0.23|0.823
71923191|NCT02790476|143367026|SUPERIORITY||Mean Difference (Final Values)|-0.03||||0.692|TWO_SIDED|95.0|-0.2|0.14||The threshold for statistical significance is p=0.05.|Mixed Models Analysis||This measure is a difference-in-difference, calculated by subtracting the pre- and post-intervention difference in mean MME in the letter (2.08-3.72 = -1.64) and control (1.84-3.51= -1.67) arms, resulting in a difference of -0.03.|Change in mean number of new patients pre- to 4-12 months post-intervention||0.14|-0.20|0.692
71923192|NCT04594213|143367071|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923193|NCT04594213|143367072|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923194|NCT04594213|143367073|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923195|NCT04594213|143367074|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923196|NCT04594213|143367075|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923197|NCT04594213|143367076|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923198|NCT04594213|143367077|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923199|NCT04594213|143367078|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923200|NCT04594213|143367079|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923201|NCT04594213|143367080|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71923202|NCT04594213|143367081|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923203|NCT04594213|143367081|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923204|NCT04594213|143367082|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923205|NCT04594213|143367082|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923206|NCT04594213|143367083|SUPERIORITY||||||<|0.0001|||||||Mantel Haenszel|||||||<0.0001
71923207|NCT04594213|143367084|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71923208|NCT04594213|143367084|SUPERIORITY||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71923209|NCT00538434|143367087|SUPERIORITY_OR_OTHER||Adjusted mean difference|-52.78|STANDARD_ERROR_OF_MEAN|11.4|<|0.0001|TWO_SIDED|95.0|-75.24|-30.32|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-30.32|-75.24|< 0.0001
71923210|NCT00538434|143367087|SUPERIORITY_OR_OTHER||Adjusted mean difference|-73.03|STANDARD_ERROR_OF_MEAN|11.29|<|0.0001|TWO_SIDED|95.0|-95.28|-50.78|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-50.78|-95.28|< 0.0001
71923211|NCT00538434|143367087|SUPERIORITY_OR_OTHER||Adjusted mean difference|-64.69|STANDARD_ERROR_OF_MEAN|11.28|<|0.0001|TWO_SIDED|95.0|-86.93|-42.45|||ANCOVA|adjustment for stratification factor and for variable at Baseline||||-42.45|-86.93|< 0.0001
71923212|NCT00538434|143367088|SUPERIORITY_OR_OTHER|||||||0.0313|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0313
71923213|NCT00538434|143367088|SUPERIORITY_OR_OTHER|||||||0.5793|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.5793
71923214|NCT00538434|143367088|SUPERIORITY_OR_OTHER|||||||0.4905|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.4905
71923215|NCT00538434|143367089|SUPERIORITY_OR_OTHER|||||||0.0062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0062
71923216|NCT00538434|143367089|SUPERIORITY_OR_OTHER|||||||0.0943|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.0943
71923217|NCT00538434|143367089|SUPERIORITY_OR_OTHER|||||||0.2955|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.2955
71923218|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.75|STANDARD_ERROR_OF_MEAN|6.48||0.4644|TWO_SIDED|95.0|-17.53|8.03||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||8.03|-17.53|0.4644
71923219|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.47|STANDARD_ERROR_OF_MEAN|6.44||0.8196|TWO_SIDED|95.0|-14.17|11.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||11.23|-14.17|0.8196
71923220|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.36|STANDARD_ERROR_OF_MEAN|6.36||0.8306|TWO_SIDED|95.0|-11.19|13.91||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score||13.91|-11.19|0.8306
71923221|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.38|STANDARD_ERROR_OF_MEAN|4.37||0.1459|TWO_SIDED|95.0|-15.01|2.24||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||2.24|-15.01|0.1459
71923222|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.41|STANDARD_ERROR_OF_MEAN|4.38||0.4375|TWO_SIDED|95.0|-12.05|5.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||5.23|-12.05|0.4375
71923223|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|4.35||0.9217|TWO_SIDED|95.0|-9.0|8.15||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score||8.15|-9.00|0.9217
71923224|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.57|STANDARD_ERROR_OF_MEAN|7.82||0.8412|TWO_SIDED|95.0|-16.98|13.85||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||13.85|-16.98|0.8412
71923225|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.54|STANDARD_ERROR_OF_MEAN|7.81||0.4794|TWO_SIDED|95.0|-20.94|9.87||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||9.87|-20.94|0.4794
71923226|NCT00538434|143367090|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.06|STANDARD_ERROR_OF_MEAN|7.66||0.8906|TWO_SIDED|95.0|-16.16|14.06||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score||14.06|-16.16|0.8906
71923227|NCT03814499|143367095|OTHER||Coefficient|-2.3|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
71923228|NCT03814499|143367096|OTHER||Coefficient|-3.8|||<|0.01|TWO_SIDED||||||Regression, Linear|||||||<0.01
71923229|NCT03814499|143367097|OTHER||Coefficient|369.9||||0.3269|TWO_SIDED||||||Regression, Linear|||||||0.3269
71923230|NCT03814499|143367098|OTHER||Coefficient|365.4||||0.4265|TWO_SIDED||||||Regression, Linear|||||||0.4265
71923231|NCT03814499|143367099|OTHER||Coefficient|264.3||||0.4782|TWO_SIDED||||||Regression, Linear|||||||0.4782
71923232|NCT03814499|143367100|OTHER||Coefficient|730.2||||0.2716|TWO_SIDED||||||Regression, Linear|||||||0.2716
71923233|NCT03814499|143367101|OTHER||Coefficient|-0.6||||0.4178|TWO_SIDED||||||Regression, Linear|||||||0.4178
71923234|NCT03814499|143367102|OTHER||Coefficient|-1.5||||0.2677|TWO_SIDED||||||Regression, Linear|||||||0.2677
71923235|NCT03814499|143367103|OTHER||Coefficient|-467.0||||0.3364|TWO_SIDED||||||Regression, Linear|||||||0.3364
71923236|NCT03814499|143367104|OTHER||Coefficient|-908.0||||0.1124|TWO_SIDED||||||Regression, Linear|||||||0.1124
71923237|NCT03814499|143367105|OTHER||Coefficient|479.2||||0.2649|TWO_SIDED||||||Regression, Linear|||||||0.2649
71923238|NCT03814499|143367106|OTHER||Coefficient|1114.3||||0.216|TWO_SIDED||||||Regression, Linear|||||||0.216
71923239|NCT03814499|143367107|OTHER||Coefficient|0.1||||0.9032|TWO_SIDED||||||Regression, Linear|||||||0.9032
71923240|NCT03814499|143367108|OTHER||Coefficient|-0.4||||0.7889|TWO_SIDED||||||Regression, Linear|||||||0.7889
71923241|NCT03814499|143367109|OTHER||Coefficient|7.0||||0.0242|TWO_SIDED||||||Regression, Linear|||||||0.0242
71923242|NCT03814499|143367110|OTHER||Coefficient|1.5||||0.5092|TWO_SIDED||||||Regression, Linear|||||||0.5092
71923243|NCT03814499|143367111|OTHER||Coefficient|-47.1||||0.3634|TWO_SIDED||||||Regression, Linear|||||||0.3634
71923244|NCT03814499|143367112|OTHER||Coefficient|-204.7||||0.0677|TWO_SIDED||||||Regression, Linear|||||||0.0677
71923245|NCT03814499|143367113|OTHER||Coefficient|-235.8||||0.156|TWO_SIDED||||||Regression, Linear|||||||0.156
71923246|NCT03814499|143367114|OTHER||Coefficient|-102.0||||0.3148|TWO_SIDED||||||Regression, Linear|||||||0.3148
71923247|NCT03814499|143367115|OTHER||Coefficient|-0.1||||0.9349|TWO_SIDED||||||Regression, Linear|||||||0.9349
71923248|NCT03814499|143367116|OTHER||Coefficient|-0.6||||0.7196|TWO_SIDED||||||Regression, Linear|||||||0.7196
71923249|NCT03814499|143367117|OTHER||Coefficient|4.7||||0.0542|TWO_SIDED||||||Regression, Linear|||||||0.0542
71923250|NCT03814499|143367118|OTHER||Coefficient|2.6||||0.4224|TWO_SIDED||||||Regression, Linear|||||||0.4224
71923251|NCT03814499|143367119|OTHER||Coeffiient|-118.9||||0.1247|TWO_SIDED||||||Regression, Linear|||||||0.1247
71923252|NCT03814499|143367120|OTHER||Coefficient|-135.2||||0.1461|TWO_SIDED||||||Regression, Linear|||||||0.1461
71923253|NCT03814499|143367121|OTHER||Coefficient|-154.2||||0.0699|TWO_SIDED||||||Regression, Linear|||||||0.0699
71923254|NCT03814499|143367122|OTHER||Coefficient|-164.6||||0.0901|TWO_SIDED||||||Regression, Linear|||||||0.0901
71923255|NCT01589185|143367124|SUPERIORITY|||||||0.3962||||||\< 0.1 is considered borderline significant|Fisher Exact|||The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.||||0.3962
71923256|NCT02046993|143367128|SUPERIORITY_OR_OTHER|||||||0.27|||||||Chi-squared|||comparison of the percentage of patients doing HBPM between intervention and control group at baseline||||0.27
71923257|NCT02046993|143367128|SUPERIORITY_OR_OTHER|||||||0.02|||||||McNemar|||Comparison of percentage of subjects doing HBPM at 3rd month from baseline within intervention group||||.020
71688806|NCT02362425|142893027|SUPERIORITY||Mean Difference (Final Values)|-2.1||||0.12|TWO_SIDED|95.0|-5.0|0.6|||t-test, 2 sided|||||0.6|-5.0|0.12
71688807|NCT02362425|142893028|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.76|TWO_SIDED|95.0|-3.6|2.7|||t-test, 2 sided|||||2.7|-3.6|0.76
71923258|NCT02046993|143367128|SUPERIORITY_OR_OTHER|||||||0.06|||||||McNemar|||comparison in percentage of patients doing Home BP monitoring at 6th month from baseline within intervention group||||.060
71923259|NCT02046993|143367128|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||McNemar|||Change in the proportion of patients doing HBPM at 3 months from baseline within the control group||||.002
71923260|NCT02046993|143367128|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED||||||McNemar|||Change in proportion of patients doing HBPM at 6 months from baseline within control group||||.009
71923261|NCT02046993|143367129|SUPERIORITY_OR_OTHER|||||||0.813|||||||t-test, 2 sided|||Comparison of baseline mean clinic systolic BP mCSBP readings between control and intervention||||0.813
71923262|NCT02046993|143367129|SUPERIORITY_OR_OTHER|||||||0.865|||||||t-test, 2 sided|||Comparison of baseline mean clinic diastolic BP mCDBP readings between control and intervention||||0.865
71923263|NCT02046993|143367129|SUPERIORITY_OR_OTHER|||||||0.476|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline||||0.476
71923264|NCT02046993|143367129|SUPERIORITY_OR_OTHER|||||||0.14|||||||t-test, 2 sided|||Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline||||0.14
71923265|NCT02046993|143367129|SUPERIORITY_OR_OTHER|||||||0.495|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline||||0.495
71923266|NCT02046993|143367129|SUPERIORITY_OR_OTHER|||||||0.967|||||||t-test, 2 sided|||Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline||||0.967
71688808|NCT02362425|142893029|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.72|TWO_SIDED|95.0|-2.5|3.5|||t-test, 2 sided|||||3.5|-2.5|0.72
71688809|NCT02362425|142893030|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.7|TWO_SIDED|95.0|-1.8|2.7|||t-test, 2 sided|||||2.7|-1.8|0.70
71923267|NCT02046993|143367130|SUPERIORITY_OR_OTHER|||||||0.819|||||||t-test, 2 sided|||Comparison of baselline SEMCD between telemonitoring group and enhanced usual care||||0.819
71923268|NCT02046993|143367130|SUPERIORITY_OR_OTHER|||||||0.512|||||||t-test, 2 sided|||Comparison of SEMCD at 3 months between telemonitoring group and enhanced usual care||||0.512
71923269|NCT02046993|143367130|SUPERIORITY_OR_OTHER|||||||0.325|||||||t-test, 2 sided|||Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group||||0.325
71923270|NCT02046993|143367131|SUPERIORITY_OR_OTHER|||||||0.532|||||||t-test, 2 sided|||comparison of baseline mHSBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.532
71923271|NCT02046993|143367131|SUPERIORITY_OR_OTHER|||||||0.902|||||||t-test, 2 sided|||comparison of baseline mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups||||0.902
71923272|NCT02046993|143367132|SUPERIORITY_OR_OTHER|||||||0.138|||||||t-test, 2 sided|||comparison of mHSBP at 3 months between smartphone based telemonitoring group and control group on enhanced usual care||||0.138
71923273|NCT02046993|143367132|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups at 3 months||||0.204
71923274|NCT02046993|143367133|SUPERIORITY_OR_OTHER|||||||0.199|||||||t-test, 2 sided|||comparison of mHSBP in mmHg between Telemonitoring groups and Enhanced Usual Care groups at 6 months||||0.199
71923275|NCT02046993|143367133|SUPERIORITY_OR_OTHER|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg at 6 months between Telemonitoring and Enhanced Usual Care groups||||0.204
71923276|NCT00598442|143367135|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.101|||TWO_SIDED|97.5|-0.09|0.36|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.36|-0.09|
71923277|NCT00598442|143367135|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|0.102|||TWO_SIDED|97.5|0.08|0.54|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.||0.54|0.08|
71923278|NCT00598442|143367136|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.28|||||TWO_SIDED|95.0|1.04|5.01|||Cochran-Mantel-Haenszel|||||5.01|1.04|
71923279|NCT00598442|143367136|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.1|||||TWO_SIDED|95.0|0.94|4.69|||Cochran-Mantel-Haenszel|||||4.69|0.94|
71688810|NCT02362425|142893031|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.88|TWO_SIDED|95.0|-2.8|3.3|||t-test, 2 sided|||||3.3|-2.8|0.88
71923280|NCT00598442|143367137|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.9|1.01|||Cochran-Mantel-Haenszel|||||1.01|0.90|
71923281|NCT00598442|143367137|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.98|||||TWO_SIDED|95.0|0.93|1.04|||Cochran-Mantel-Haenszel|||||1.04|0.93|
71923282|NCT00679354|143367155|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.0||||1|TWO_SIDED||||||Spearman's Correlation|||||||1.000
71688811|NCT02362425|142893032|SUPERIORITY||Mean Difference (Final Values)|2.5||||0.61|TWO_SIDED|95.0|-10.3|15.2|||t-test, 2 sided|||||15.2|-10.3|0.61
71688812|NCT02362425|142893033|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.87|TWO_SIDED|95.0|-7.4|8.5|||t-test, 2 sided|||||8.5|-7.4|0.87
71688813|NCT02362425|142893034|SUPERIORITY||Mean Difference (Final Values)|-12.5||||0.28|TWO_SIDED|95.0|-38.9|13.9|||t-test, 2 sided|||||13.9|-38.9|0.28
71923283|NCT00679354|143367156|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|0.56||||0.057|TWO_SIDED||||||Spearman's Correlation|||||||0.057
71923284|NCT00679354|143367157|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.22||||0.495|TWO_SIDED||||||Spearman's Correlation|||||||0.495
71923285|NCT00679354|143367158|SUPERIORITY_OR_OTHER||Spearman's Correlation Coefficient|-0.48||||0.114|TWO_SIDED||||||Spearman's Correlation|||||||0.114
71923286|NCT03947333|143367170|SUPERIORITY||Mean Difference (Final Values)|1.6||||0.221|TWO_SIDED||||||t-test, 1 sided|||||||0.221
71923287|NCT03947333|143367170|OTHER||fixed-effects estimate of intervention|0.846||||0.559|TWO_SIDED|95.0|-1.99|3.68|||Mixed Models Analysis|||Mixed effects model||3.68|-1.99|0.559
71923288|NCT03947333|143367171|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.532|TWO_SIDED||||||t-test, 1 sided|||||||0.532
71923289|NCT03947333|143367172|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.086|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.086
71923290|NCT03947333|143367172|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.562|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.562
71923291|NCT03947333|143367172|OTHER||fixed-effects estimate of intervention|0.348||||0.451|TWO_SIDED|95.0|-0.557|1.254|||Mixed Models Analysis|||Mixed Effects Model||1.254|-0.557|0.451
71923292|NCT03947333|143367173|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.27|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.270
71923293|NCT03947333|143367173|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.299|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.299
71923294|NCT03947333|143367173|OTHER||fixed-effects estimate of intervention|0.1||||0.917|TWO_SIDED|95.0|-1.786|1.986|||Mixed Models Analysis|||Mixed effects model||1.986|-1.786|0.917
71923295|NCT03947333|143367174|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.093|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.093
71923296|NCT03947333|143367174|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.034|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.034
71923297|NCT03947333|143367174|OTHER||fixed-effects estimate of intervention|0.242||||0.103|TWO_SIDED|95.0|-0.049|0.533|||Mixed Models Analysis|||Mixed Effects Model||0.533|-0.049|0.103
71923298|NCT03947333|143367175|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.116|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.116
71923299|NCT03947333|143367175|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.009|TWO_SIDED||||||t-test, 1 sided|||||||0.009
71923300|NCT03947333|143367175|OTHER||fixed-effects estimate of intervention|0.183||||0.178|TWO_SIDED|95.0|-0.084|0.451|||Mixed Models Analysis|||Mixed Effects Model||0.451|-0.084|0.178
71923301|NCT03947333|143367176|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.188|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.188
71923302|NCT03947333|143367176|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.749|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.749
71923303|NCT03947333|143367176|OTHER||fixed-effects estimate of intervention|0.031||||0.847|TWO_SIDED|95.0|-0.288|0.351|||Mixed Models Analysis|||Mixed Effects Model||0.351|-0.288|0.847
71923304|NCT03947333|143367177|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.182|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.182
71923305|NCT03947333|143367177|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.158|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.158
71923306|NCT03947333|143367177|OTHER||fixed-effects estimate of intervention|0.107||||0.612|TWO_SIDED|95.0|-0.305|0.519|||Mixed Models Analysis|||Mixed Effects Model||0.519|-0.305|0.612
71923307|NCT03947333|143367178|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.97|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.970
71923308|NCT03947333|143367178|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.786|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.786
71923309|NCT03947333|143367178|OTHER||fixed-effects estimate of intervention|-0.088||||0.67|TWO_SIDED|95.0|-0.493|0.317|||Mixed Models Analysis|||Mixed Effects Model||0.317|-0.493|0.670
71688814|NCT02579382|142893072|SUPERIORITY||Least Squares Mean Difference|0.107||||0.227|TWO_SIDED|95.0|-0.067|0.282||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.282|-0.067|0.227
71923310|NCT03947333|143367179|SUPERIORITY||Median Difference (Final Values)|0.0||||0.478|TWO_SIDED||||||t-test, 1 sided|||Change at 3 months||||0.478
71923311|NCT03947333|143367179|SUPERIORITY||Mean Difference (Net)|-0.2||||0.666|TWO_SIDED||||||t-test, 1 sided|||Change at 6 months||||0.666
71923312|NCT03947333|143367179|OTHER||fixed-effects estimate of intervention|-0.15||||0.601|TWO_SIDED|95.0|-0.713|0.413|||Mixed Models Analysis|||Mixed Effects Model||0.413|-0.713|0.601
71923313|NCT03947333|143367180|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.654|TWO_SIDED||||||t-test, 1 sided|||||||0.654
71923314|NCT03947333|143367181|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.485|TWO_SIDED||||||t-test, 1 sided|||||||0.485
71923315|NCT03947333|143367182|OTHER|||||||0.48|||||||McNemar|||||||0.480
71923316|NCT03947333|143367182|OTHER|||||||0.023|||||||McNemar|||||||0.023
71923317|NCT03947333|143367183|SUPERIORITY||Mean Difference (Final Values)|0.8||||0.542|TWO_SIDED||||||t-test, 1 sided|||||||0.542
71923318|NCT02898662|143367190|OTHER|The null hypothesis was that during the 52-week double-blind treatment period, the time to LOAC in the AZD1419 arm was equal to the corresponding time to LOAC in the placebo arm.|Hazard Ratio (HR)|1.05||||0.5722|TWO_SIDED|95.0|0.59|1.87||1-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to LOAC. Cox regression model analysis with age and gender included as covariates.||1.87|0.59|0.5722
71923319|NCT02898662|143367191|OTHER||Odds Ratio (OR)|1.86||||0.2006|TWO_SIDED|95.0|0.72|4.79||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants experiencing LOAC. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment, visit and age and gender as covariates.||4.79|0.72|0.2006
71923320|NCT02898662|143367192|OTHER||LS Mean difference|-0.02||||0.8166|TWO_SIDED|95.0|-0.22|0.17||2-sided p-value|Repeated measures analysis|||Comparison between groups for ACQ-5 score. Repeated measures analysis.||0.17|-0.22|0.8166
71923321|NCT02898662|143367193|OTHER||LS Mean difference|-0.03||||0.8412|TWO_SIDED|95.0|-0.32|0.26||2-sided p-value|Repeated measures analysis|||Comparison between groups for asthma daily diary score. Repeated measures analysis.||0.26|-0.32|0.8412
71923322|NCT02898662|143367194|OTHER|The null hypothesis was that the time to moderate or severe exacerbation was not different between AZD1419 and placebo.|Hazard Ratio (HR)|0.8||||0.5477|TWO_SIDED|95.0|0.38|1.67||2-sided p-value|Regression, Cox||Hazard ratio \< 1 favours AZD1419 over placebo.|Comparison between groups for time to moderate or severe asthma exacerbation. Cox regression model analysis with age and gender included as covariates.||1.67|0.38|0.5477
71923323|NCT02898662|143367194|OTHER||Odds Ratio (OR)|0.88||||0.7294|TWO_SIDED|95.0|0.41|1.86||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants with moderate or severe asthma exacerbation. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment and visit as covariates.||1.86|0.41|0.7294
71923324|NCT02898662|143367196|OTHER||LS Mean difference|0.06||||0.3764|TWO_SIDED|95.0|-0.08|0.2||2-sided p-value|Repeated measures analysis|||Comparison between groups for pre-BD FEV1. Repeated measures analysis.||0.20|-0.08|0.3764
71923325|NCT02898662|143367196|OTHER||LS Mean difference|-0.03||||0.7013|TWO_SIDED|95.0|-0.17|0.11||2-sided p-value|Repeated measures analysis|||Comparison between groups for post-BD FEV1. Repeated measures analysis.||0.11|-0.17|0.7013
71923326|NCT02898662|143367197|OTHER||LS Mean difference|-0.32||||0.9686|TWO_SIDED|95.0|-16.54|15.9||2-sided p-value|Repeated measures analysis|||Comparison between groups for PEF. Repeated measures analysis.||15.90|-16.54|0.9686
71923327|NCT02898662|143367198|OTHER||LS Mean difference|-2.02||||0.5403|TWO_SIDED|95.0|-8.55|4.52||2-sided p-value|Repeated measures analysis|||Comparison between groups for FeNO. Repeated measures analysis.||4.52|-8.55|0.5403
71923328|NCT03432819|143367215|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Net)|9.24||||0.06|TWO_SIDED|95.0|-0.55|19.03|||Regression, Linear|||||19.03|-0.55|0.06
71923329|NCT03432819|143367216|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|4.5||||0.02|TWO_SIDED|95.0|0.7|8.3|||Regression, Linear|||||8.30|0.70|0.02
71923330|NCT03432819|143367217|SUPERIORITY|Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.|Mean Difference (Final Values)|0.08||||0.39|TWO_SIDED|95.0|-0.1|0.26|||Regression, Linear|||||0.26|-0.10|0.39
71923331|NCT03432819|143367218|SUPERIORITY||Median Difference (Final Values)|-0.09||||0.54|TWO_SIDED|95.0|-0.37|0.2|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.20|-0.37|0.54
71923332|NCT03432819|143367219|SUPERIORITY||Median Difference (Final Values)|-0.02||||0.81|TWO_SIDED|95.0|-0.18|0.14|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.14|-0.18|0.81
71923333|NCT03432819|143367220|SUPERIORITY||Median Difference (Final Values)|-0.18||||0.06|TWO_SIDED|95.0|-0.37|0.01|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.01|-0.37|0.06
71688815|NCT02579382|142893072|SUPERIORITY||Least Squares Mean Difference|0.018||||0.84|TWO_SIDED|95.0|-0.156|0.191||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.191|-0.156|0.840
71923334|NCT03432819|143367221|SUPERIORITY||Mean Difference (Final Values)|-0.33||||0.16|TWO_SIDED|95.0|-0.78|0.13|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.13|-0.78|0.16
71688816|NCT02579382|142893072|SUPERIORITY||Least Squares Mean Difference|0.127||||0.151|TWO_SIDED|95.0|-0.047|0.301||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM|||||0.301|-0.047|0.151
71923335|NCT03432819|143367222|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.02|TWO_SIDED|95.0|-0.84|-0.09|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||-0.09|-0.84|0.02
71923336|NCT03432819|143367223|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.71|TWO_SIDED|95.0|-0.32|0.47|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.47|-0.32|0.71
71923337|NCT03432819|143367224|SUPERIORITY||Mean Difference (Final Values)|-0.34||||0.1|TWO_SIDED|95.0|-0.73|0.06|||Regression, Linear|||Using an intent-to-treat approach, intervention efficacy was tested with a hierarchical linear repeated-measures regressions where responses came from either follow-up, and MEMS adherence from 5, 6, or 7 month measurements. Predictors were an indicator for study arm, baseline value, follow-up time-point, and covariates. Standard errors were adjusted for clustering at the individual-level (ultimate clustering methods). Covariates were socio-demographics associated with the outcome at p\>.05.||0.06|-0.73|0.10
71923338|NCT02347124|143367225|SUPERIORITY||Odds Ratio (OR)|1.29||||0.13|TWO_SIDED|95.0|0.93|1.78||Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.|Regression, Logistic|||||1.78|0.93|0.13
71923339|NCT02347124|143367226|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9|TWO_SIDED|95.0|0.69|1.53||Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.|Regression, Logistic|||||1.53|0.69|0.90
71923340|NCT02347124|143367227|SUPERIORITY||Odds Ratio (OR)|1.22||||0.21|TWO_SIDED|95.0|0.89|1.69||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.69|0.89|0.21
71923341|NCT02347124|143367228|SUPERIORITY||Odds Ratio (OR)|1.42||||0.04|TWO_SIDED|95.0|1.01|2.0||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||2.00|1.01|0.04
71923342|NCT02347124|143367229|SUPERIORITY||Odds Ratio (OR)|1.37||||0.09|TWO_SIDED|95.0|0.95|1.96||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic|||||1.96|0.95|0.09
71923343|NCT02347124|143367230|SUPERIORITY||Odds Ratio (OR)|-0.05||||0.85|TWO_SIDED|95.0|-0.57|0.47|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.47|-0.57|0.85
71923344|NCT02347124|143367231|SUPERIORITY||Odds Ratio (OR)|0.41||||0.14|TWO_SIDED|95.0|-0.14|0.96|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.||||0.96|-0.14|0.14
71923345|NCT02347124|143367232|SUPERIORITY||Odds Ratio (OR)|0.35||||0.002|TWO_SIDED|95.0|0.13|0.56|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline self-efficacy score.||||0.56|0.13|.002
71923346|NCT02347124|143367233|SUPERIORITY||Odds Ratio (OR)|0.0||||0.97|TWO_SIDED|95.0|-0.22|0.23||Adjusted for sex, age, state quit line, and baseline self-efficacy score.|Regression, Linear|||||0.23|-0.22|0.97
71923347|NCT02347124|143367234|SUPERIORITY||Odds Ratio (OR)|-0.1||||0.16|TWO_SIDED|95.0|-0.24|0.04|||Regression, Linear|Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.||||0.04|-0.24|0.16
71923348|NCT02347124|143367235|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.83|TWO_SIDED|95.0|-0.16|0.13|||Regression, Linear|Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.||||0.13|-0.16|0.83
71923349|NCT02347124|143367236|SUPERIORITY||Odds Ratio (OR)|0.22||||0.02|TWO_SIDED|95.0|0.04|0.41|||Regression, Linear|adjusted for sex, age, state quit line, and baseline motivation score.||||0.41|0.04|0.02
71923350|NCT02347124|143367237|SUPERIORITY||Odds Ratio (OR)|0.02||||0.82|TWO_SIDED|95.0|-0.17|0.21|||Regression, Linear|||||0.21|-0.17|0.82
71923351|NCT02347124|143367238|SUPERIORITY||Odds Ratio (OR)|-0.02||||0.8|TWO_SIDED|95.0|-0.2|0.16|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.||||0.16|-0.20|0.80
71923352|NCT02347124|143367239|SUPERIORITY||Odds Ratio (OR)|0.07||||0.45|TWO_SIDED|95.0|-0.11|0.26|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.||||0.26|-0.11|0.45
71923353|NCT01522391|143367264|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
71923354|NCT01522391|143367265|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||||0.491|0.004|0.012
71923355|NCT01522391|143367266|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.66|0.022|0.242
71923356|NCT01522391|143367266|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
71923357|NCT01522391|143367267|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7||2.660|0.022|0.242
71923358|NCT01522391|143367267|OTHER||Ratio between geometric means|0.428||||0.482|TWO_SIDED|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21||4.696|0.039|0.482
71923359|NCT01522391|143367268|OTHER||Ratio between geometric means|0.288||||0.395|TWO_SIDED|95.0|0.016|5.221|||Mixed Models Analysis|||Day 7||5.221|0.016|0.395
71923360|NCT01522391|143367268|OTHER||Ratio between geometric means|0.067||||0.067|TWO_SIDED|95.0|0.004|1.218|||Mixed Models Analysis|||Day 14||1.218|0.004|0.067
71923361|NCT01522391|143367268|OTHER||Ratio between geometric means|0.484||||0.62|TWO_SIDED|95.0|0.027|8.787|||Mixed Models Analysis|||Day 21||8.787|0.027|0.620
71923362|NCT01522391|143367269|OTHER||Ratio between geometric means|0.287||||0.403|TWO_SIDED|95.0|0.015|5.55|||Mixed Models Analysis|||Day 7||5.550|0.015|0.403
71923363|NCT01522391|143367269|OTHER||Ratio between geometric means|0.032||||0.021|TWO_SIDED|95.0|0.002|0.583|||Mixed Models Analysis|||Day 14||0.583|0.002|0.021
71923364|NCT01522391|143367269|OTHER||Ratio between geometric means|0.271||||0.368|TWO_SIDED|95.0|0.015|4.779|||Mixed Models Analysis|||Day 21||4.779|0.015|0.368
71923365|NCT01522391|143367270|OTHER||Ratio between geometric means|1.045||||0.97|TWO_SIDED|95.0|0.106|10.32|||Mixed Models Analysis|||Day 7||10.32|0.106|0.970
71923366|NCT01522391|143367270|OTHER||Ratio between geometric means|0.045||||0.009|TWO_SIDED|95.0|0.005|0.447|||Mixed Models Analysis|||Day 14||0.447|0.005|0.009
71923367|NCT01522391|143367270|OTHER||Ratio between geometric means|0.36||||0.377|TWO_SIDED|95.0|0.036|3.556|||Mixed Models Analysis|||Day 21||3.556|0.036|0.377
71923368|NCT01522391|143367271|OTHER||Ratio between geometric means|0.961||||0.974|TWO_SIDED|95.0|0.081|11.43|||Mixed Models Analysis|||Day 7||11.43|0.081|0.974
71923369|NCT01522391|143367271|OTHER||Ratio between geometric means|0.046||||0.013|TWO_SIDED|95.0|0.004|0.512|||Mixed Models Analysis|||Day 14||0.512|0.004|0.013
71923370|NCT01522391|143367271|OTHER||Ratio between geometric means|0.447||||0.504|TWO_SIDED|95.0|0.041|4.883|||Mixed Models Analysis|||Day 21||4.883|0.041|0.504
71923371|NCT01522391|143367272|OTHER||Ratio between geometric means|0.242||||0.242|TWO_SIDED|95.0|0.022|2.659|||Mixed Models Analysis|||Day 7||2.659|0.022|0.242
71923372|NCT01522391|143367272|OTHER||Ratio between geometric means|0.045||||0.012|TWO_SIDED|95.0|0.004|0.491|||Mixed Models Analysis|||Day 14||0.491|0.004|0.012
71923373|NCT01522391|143367272|OTHER||Ratio between geometric means|0.428||||0.483|TWO_SIDED|95.0|0.039|4.697|||Mixed Models Analysis|||Day 21||4.697|0.039|0.483
71923374|NCT01522391|143367273|OTHER||Ratio between geometric means|0.202||||0.197|TWO_SIDED|95.0|0.017|2.34|||Mixed Models Analysis|||Day 7||2.340|0.017|0.197
71923375|NCT01522391|143367273|OTHER||Ratio between geometric means|0.021||||0.002|TWO_SIDED|95.0|0.002|0.227|||Mixed Models Analysis|||Day 14||0.227|0.002|0.002
71923376|NCT01522391|143367273|OTHER||Ratio between geometric means|0.257||||0.257|TWO_SIDED|95.0|0.024|2.752|||Mixed Models Analysis|||Day 21||2.752|0.024|0.257
71923377|NCT01522391|143367274|OTHER||Least Square Mean Difference|20.38||||0.346|TWO_SIDED|95.0|-22.42|63.19|||Mixed Models Analysis|||Day 7||63.19|-22.42|0.346
71923378|NCT01522391|143367274|OTHER||Least Square Mean Difference|29.1||||0.18|TWO_SIDED|95.0|-13.71|71.9|||Mixed Models Analysis|||Day 14||71.90|-13.71|0.18
71923379|NCT01522391|143367274|OTHER||Least Square Mean Difference|-11.64||||0.59|TWO_SIDED|95.0|-54.44|31.16|||Mixed Models Analysis|||Day 21||31.16|-54.44|0.590
71923380|NCT01522391|143367275|OTHER||Least Square Mean Difference|5.95||||0.748|TWO_SIDED|95.0|-30.84|42.73|||Mixed Models Analysis|||Day 7||42.73|-30.84|0.748
71923381|NCT01522391|143367275|OTHER||Least Square Mean Difference|14.62||||0.437|TWO_SIDED|95.0|-22.65|51.88|||Mixed Models Analysis|||Day 14||51.88|-22.65|0.437
71923382|NCT01522391|143367275|OTHER||Least Square Mean Difference|-18.66||||0.322|TWO_SIDED|95.0|-55.92|18.61|||Mixed Models Analysis|||Day 21||18.61|-55.92|0.322
71923383|NCT01522391|143367276|OTHER||Least Square Mean Difference|8.04||||0.631|TWO_SIDED|95.0|-25.15|41.24|||Mixed Models Analysis|||Day 7||41.24|-25.15|0.631
71923384|NCT01522391|143367276|OTHER||Least Square Mean Difference|20.44||||0.224|TWO_SIDED|95.0|-12.75|53.63|||Mixed Models Analysis|||Day 14||53.63|-12.75|0.224
71923385|NCT01522391|143367276|OTHER||Least Square Mean Difference|-1.23||||0.941|TWO_SIDED|95.0|-34.42|31.96|||Mixed Models Analysis|||Day 21||31.96|-34.42|0.941
71923386|NCT01522391|143367277|OTHER||Least Square Means Difference|0.97||||0.954|TWO_SIDED|95.0|-32.93|34.87|||Mixed Models Analysis|||Day 7||34.87|-32.93|0.954
71923387|NCT01522391|143367277|OTHER||Least Square Mean Difference|15.72||||0.358|TWO_SIDED|95.0|-18.18|49.62|||Mixed Models Analysis|||Day 14||49.62|-18.18|0.358
71923388|NCT01522391|143367277|OTHER||least Square Mean Difference|-7.94||||0.642|TWO_SIDED|95.0|-41.82|25.94|||Mixed Models Analysis|||Day 21||25.94|-41.82|0.642
71923389|NCT01522391|143367278|OTHER|||||||0.701|||||||Cochran-Mantel-Haenszel|||Day 7||||0.701
71923390|NCT01522391|143367278|OTHER|||||||0.898|||||||Cochran-Mantel-Haenszel|||Day 14||||0.898
71923391|NCT01522391|143367278|OTHER|||||||0.271|||||||Cochran-Mantel-Haenszel|||Day 21||||0.271
71923392|NCT01522391|143367279|OTHER|||||||0.511|||||||Cochran-Mantel-Haenszel|||Day 7||||0.511
71923393|NCT01522391|143367279|OTHER|||||||0.777|||||||Cochran-Mantel-Haenszel|||Day 14||||0.777
71923394|NCT01522391|143367279|OTHER|||||||0.204|||||||Cochran-Mantel-Haenszel|||Day 21||||0.204
71923395|NCT01522391|143367280|OTHER|||||||0.489|||||||Cochran-Mantel-Haenszel|||Day 7||||0.489
71923396|NCT01522391|143367280|OTHER|||||||0.249|||||||Cochran-Mantel-Haenszel|||Day 14||||0.249
71923397|NCT01522391|143367280|OTHER|||||||0.098|||||||Cochran-Mantel-Haenszel|||Day 21||||0.098
71923398|NCT01522391|143367281|OTHER|||||||0.291|||||||Cochran-Mantel-Haenszel|||Day 7||||0.291
71923399|NCT01522391|143367281|OTHER|||||||0.113|||||||Cochran-Mantel-Haenszel|||Day 14||||0.113
71923400|NCT01522391|143367281|OTHER|||||||0.033|||||||Cochran-Mantel-Haenszel|||Day 21||||0.033
71923401|NCT01522391|143367282|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
71923402|NCT01522391|143367282|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 14||||0.825
71923403|NCT01522391|143367282|OTHER|||||||0.208|||||||Cochran-Mantel-Haenszel|||||||0.208
71923404|NCT01522391|143367283|OTHER|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7||||0.825
71923405|NCT01522391|143367283|OTHER|||||||0.82|||||||Cochran-Mantel-Haenszel|||Day 14||||0.820
71923406|NCT01522391|143367283|OTHER|||||||0.086|||||||Cochran-Mantel-Haenszel|||Day 21||||0.086
71923407|NCT01522391|143367284|OTHER|||||||0.378|||||||Cochran-Mantel-Haenszel|||Day 7||||0.378
71923408|NCT01522391|143367284|OTHER|||||||0.975|||||||Cochran-Mantel-Haenszel|||Day 14||||0.975
71923409|NCT01522391|143367284|OTHER|||||||0.962|||||||Cochran-Mantel-Haenszel|||Day 21||||0.962
71923410|NCT01522391|143367285|OTHER|||||||0.375|||||||Cochran-Mantel-Haenszel|||Day 7||||0.375
71923411|NCT01522391|143367285|OTHER|||||||0.946|||||||Cochran-Mantel-Haenszel|||Day 14||||0.946
71923412|NCT01522391|143367285|OTHER|||||||0.495|||||||Cochran-Mantel-Haenszel|||Day 21||||0.495
71923413|NCT01522391|143367288|OTHER|||||||0.477|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.477
71923414|NCT01522391|143367288|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Day 14 morning||||0.651
71923415|NCT01522391|143367288|OTHER|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 21 morning||||0.340
71923416|NCT01522391|143367289|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning||||0.300
71923417|NCT01522391|143367289|OTHER|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||Day 14||||0.705
71923418|NCT01522391|143367289|OTHER|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Day 21||||0.286
71923419|NCT00195702|143367300|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
71923420|NCT00195702|143367300|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson's chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.||||<0.001
71923421|NCT00195702|143367301|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
71923422|NCT00195702|143367301|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.||||<0.001
71923423|NCT00195702|143367302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71923424|NCT00195702|143367302|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71923425|NCT00195702|143367303|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||ANCOVA|||||||<0.01
71923426|NCT00195702|143367303|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71923427|NCT00195702|143367304|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71923428|NCT00195702|143367304|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71688817|NCT03026283|142893097|OTHER|||||||1||||||In order to evaluate the significance of sensitivity and specificity findings, we implement McNemar's test comparing sensitivity and specificity for CCTA alone and FFR-CT, assuming conditional dependence.|Chi-squared|||Reference test is positive (test of sensitivity).||||1.00
71688818|NCT03026283|142893097|OTHER||||||<|0.0047||||||In order to evaluate the significance of sensitivity and specificity findings, we implement Mcnemar's test comparing sensitive and pscificity for CCTA and FFR-CT assuming dependence.|Chi-squared|McNemar's chi-squared = 8.00||Reference test is Negative||||<0.0047
71688819|NCT03782571|142893104|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|1.7|STANDARD_ERROR_OF_MEAN|1.97|||TWO_SIDED|99.1|-4.0|7.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere clearance rate.||7.4|-4.0|
71688820|NCT03782571|142893104|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|3.01|||TWO_SIDED|99.1|-4.0|13.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere clearance rate.||13.4|-4.0|
71923429|NCT00195702|143367305|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
71923430|NCT00195702|143367305|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p\<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.||||<0.001
71923431|NCT00195702|143367306|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71923432|NCT00195702|143367306|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71923433|NCT00195702|143367308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71923434|NCT00195702|143367308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71923435|NCT00195702|143367312|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71923436|NCT00195702|143367312|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71923437|NCT01336647|143367335|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size\>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher's Exact test was used to compare treatment arms, instead of the CMH test.|||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|The assessment of statistical significance will be done using Hochberg's modified Bonferroni test.||Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison||||<0.001
71688821|NCT03782571|142893104|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.2|STANDARD_ERROR_OF_MEAN|3.78|||TWO_SIDED|99.1|-2.7|19.1|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere clearance rate.||19.1|-2.7|
71688822|NCT03782571|142893104|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|3.12|||TWO_SIDED|99.1|-2.6|15.5|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere clearance rate.||15.5|-2.6|
71688823|NCT03782571|142893104|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|99.1|-2.0|8.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere clearance rate.||8.9|-2.0|
71923438|NCT00994123|143367343|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.008|TWO_SIDED|95.0|0.16|0.76|||Log Rank|||||0.76|0.16|0.008
71923439|NCT00994123|143367343|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.15||||0.059|TWO_SIDED|95.0|0.97|4.76|||Log Rank|||||4.76|0.97|0.059
71923440|NCT00151775|143367363|SUPERIORITY_OR_OTHER|||||||0.0008||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0008
71923441|NCT00151775|143367363|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
71923442|NCT00151775|143367363|SUPERIORITY_OR_OTHER|||||||0.0032||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||0.0032
71923443|NCT00151775|143367363|SUPERIORITY_OR_OTHER|||||||0.0265||95.0|||||Regression, Linear|||Weight adjusted dosage||||0.0265
71923444|NCT00151775|143367363|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Non-weight adjusted dosage||||<0.0001
71923445|NCT00151775|143367363|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Regression, Linear|||Weight adjusted dosage||||<0.0001
71923446|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|0.69||||0.0008||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0008
71923447|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-0.057||||0.0026||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0026
71923448|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-0.85||||0.0032||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0032
71923449|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-0.58||||0.0125||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0125
71923450|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-0.75|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71923451|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-0.57|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71923452|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-8.97|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71923453|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-8.15|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71923454|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-7.17||||0.0265||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0265
71923455|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-6.85||||0.0084||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||0.0084
71923456|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-8.36|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71923457|NCT00151775|143367364|SUPERIORITY_OR_OTHER||Slope|-7.71|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.||||<0.0001
71923458|NCT00151775|143367365|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.58||||0.0093|TWO_SIDED|95.0|-6.27|-0.89|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||-0.89|-6.27|0.0093
71923459|NCT00151775|143367365|SUPERIORITY_OR_OTHER||LS Mean difference|-3.49||||0.0052|TWO_SIDED|95.0|-5.92|-1.05|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||-1.05|-5.92|0.0052
71923460|NCT00151775|143367365|SUPERIORITY_OR_OTHER||LS Mean difference|-2.57||||0.133|TWO_SIDED|95.0|-5.93|0.79|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.||0.79|-5.93|0.1330
71923461|NCT00151775|143367365|SUPERIORITY_OR_OTHER||LS Mean difference|-1.38||||0.3442|TWO_SIDED|95.0|-4.27|1.5|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.||1.50|-4.27|0.3442
71923462|NCT00151775|143367365|SUPERIORITY_OR_OTHER||LS Mean difference|-3.16||||0.0029|TWO_SIDED|95.0|-5.24|-1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested||-1.09|-5.24|0.0029
71923463|NCT00151775|143367365|SUPERIORITY_OR_OTHER||LS Mean difference|-2.8||||0.0032|TWO_SIDED|95.0|-4.65|-0.95|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||-0.95|-4.65|0.0032
71923464|NCT00151775|143367366|SUPERIORITY_OR_OTHER||LS Mean difference|-2.82||||0.2113|TWO_SIDED|95.0|-7.29|1.65|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested.||1.65|-7.29|0.2113
71923465|NCT00151775|143367366|SUPERIORITY_OR_OTHER||LS Mean difference|-2.92||||0.1496|TWO_SIDED|95.0|-6.92|1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.||1.09|-6.92|0.1496
71923466|NCT01008059|143367373|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<.05
71923467|NCT02322866|143367390|SUPERIORITY||Least Squares Mean Difference|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.8|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|||-2.9|-5.8|< 0.0001
71923468|NCT02322866|143367391|SUPERIORITY||Treatment Rate Difference|7.3||||0.0038|TWO_SIDED|95.0|2.53|12.07||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo|||12.07|2.53|0.0038
71923469|NCT02322866|143367392|SUPERIORITY||Least Squares Mean Difference|-14.4|||<|0.0001|TWO_SIDED|95.0|-19.4|-9.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12||-9.5|-19.4|< 0.0001
71923470|NCT02322866|143367393|SUPERIORITY||Least Squares Mean Difference|-12.6|||<|0.0001|TWO_SIDED|95.0|-17.3|-7.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9||-7.9|-17.3|< 0.0001
71923471|NCT02322866|143367394|SUPERIORITY||Least Squares Mean Difference|-11.8|||<|0.0001|TWO_SIDED|95.0|-16.1|-7.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6||-7.5|-16.1|< 0.0001
71923472|NCT02322866|143367395|SUPERIORITY||Least Squares Mean Difference|-9.4|||<|0.0001|TWO_SIDED|95.0|-13.5|-5.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3||-5.3|-13.5|< 0.0001
71923473|NCT02322866|143367396|SUPERIORITY||Least Squares Mean Difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-5.2|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9||-2.5|-5.2|< 0.0001
71923474|NCT02322866|143367397|SUPERIORITY||Least Squares Mean Difference|-3.7|||<|0.0001|TWO_SIDED|95.0|-5.0|-2.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6||-2.4|-5.0|< 0.0001
71923475|NCT02322866|143367398|SUPERIORITY||Least Squares Mean Difference|-2.9|||<|0.0001|TWO_SIDED|95.0|-4.1|-1.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3||-1.7|-4.1|< 0.0001
71923476|NCT02181634|143367410|SUPERIORITY||Hazard Ratio (HR)|2.02||||0.099|TWO_SIDED|95.0|0.86|4.75|||Log Rank|||||4.75|0.86|0.099
71923477|NCT02181634|143367411|SUPERIORITY||Hazard Ratio (HR)|1.54||||0.34|TWO_SIDED|95.0|0.64|3.71|||Log Rank|||||3.71|0.64|0.34
71923478|NCT02145949|143367418|OTHER|||||||0.03|||||||ANCOVA|||||||.03
71923479|NCT02145949|143367419|OTHER|||||||0.01|||||||ANCOVA|||||||.01
71923480|NCT02145949|143367420|OTHER|||||||0.04|||||||ANCOVA|||||||.04
71923481|NCT02145949|143367421|OTHER|||||||0.01|||||||ANCOVA|||||||.01
71923482|NCT02145949|143367422|OTHER|||||||0.12|||||||ANCOVA|||||||.12
71923483|NCT02145949|143367423|OTHER|||||||0.03|||||||ANCOVA|||||||.03
71923484|NCT02145949|143367424|OTHER|||||||0.71|||||||ANCOVA|||||||.71
71923485|NCT02145949|143367425|OTHER|||||||0.76|||||||ANCOVA|||||||.76
71923486|NCT02145949|143367426|OTHER|||||||0.4|||||||ANCOVA|||||||.40
71923487|NCT02145949|143367427|OTHER|||||||0.97|||||||ANCOVA|||||||.97
71923488|NCT02145949|143367428|OTHER|||||||0.89|||||||ANCOVA|||||||.89
71923489|NCT02145949|143367429|OTHER|||||||0.48|||||||ANCOVA|||||||.48
71923490|NCT02145949|143367430|OTHER|||||||0.02|||||||ANCOVA|||||||.02
71923491|NCT02145949|143367431|OTHER|||||||0.29|||||||ANCOVA|||||||.29
71923492|NCT02145949|143367432|OTHER|||||||0.33|||||||ANCOVA|||||||.33
71923493|NCT02145949|143367433|OTHER|||||||0.3|||||||ANCOVA|||||||.30
71923494|NCT02145949|143367434|OTHER|||||||0.98|||||||ANCOVA|||||||.98
71923495|NCT02145949|143367435|OTHER|||||||0.18|||||||ANCOVA|||||||.18
71923496|NCT02145949|143367436|OTHER|||||||0.52|||||||ANCOVA|||||||.52
71923497|NCT02145949|143367437|OTHER|||||||0.81|||||||ANCOVA|||||||.81
71923498|NCT02843282|143367444|SUPERIORITY||Mean Difference (Net)|0.69||||0.04|TWO_SIDED||||||Regression, Linear|||||||0.040
71923499|NCT02843282|143367445|SUPERIORITY||Mean Difference (Net)|0.98||||0.004|TWO_SIDED||||||Regression, Linear|||||||0.004
71688824|NCT03782571|142893104|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|2.54|||TWO_SIDED|99.1|-4.3|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere clearance rate.||10.3|-4.3|
71923500|NCT02843282|143367446|SUPERIORITY||Mean Difference (Net)|1.95|||<|0.001|TWO_SIDED||||||Regression, Linear|||||||<0.001
71923501|NCT02843282|143367447|SUPERIORITY||Mean Difference (Net)|0.52||||0.039|TWO_SIDED||||||Regression, Linear|||||||0.039
71923502|NCT02843282|143367448|SUPERIORITY||Mean Difference (Net)|0.42||||0.092|TWO_SIDED||||||Regression, Linear|||||||0.092
71923503|NCT02843282|143367449|SUPERIORITY||Mean Difference (Net)|6.58||||0.052|TWO_SIDED||||||Regression, Linear|||||||0.052
71923504|NCT02843282|143367450|SUPERIORITY||Mean Difference (Net)|0.52||||0.121|TWO_SIDED||||||Regression, Linear|||||||0.121
71923505|NCT02843282|143367451|SUPERIORITY||Mean Difference (Net)|1.23||||0.019|TWO_SIDED||||||Regression, Linear|||||||0.019
71923506|NCT02843282|143367452|SUPERIORITY||Mean Difference (Net)|0.37||||0.278|TWO_SIDED||||||Regression, Linear|||||||0.278
71923507|NCT02843282|143367453|SUPERIORITY||Mean Difference (Net)|7.0||||0.095|TWO_SIDED||||||Regression, Linear|||||||0.095
71923508|NCT02843282|143367454|OTHER||Mean Difference (Net)|0.15|||<|0.01|TWO_SIDED||||||Whole brain voxel-wise correlation analy|||||||< 0.01
71923509|NCT02843282|143367455|SUPERIORITY||Mean Difference (Net)|1.22||||0.001|TWO_SIDED||||||Regression, Linear|||||||0.001
71923510|NCT02843282|143367456|SUPERIORITY||Mean Difference (Net)|1.33||||0.007|TWO_SIDED||||||Regression, Linear|||||||0.007
71923511|NCT04550234|143367457|OTHER||Geometric mean ratio|57.73|||||TWO_SIDED|90.0|47.07|70.81||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||70.81|47.07|
71923512|NCT04550234|143367457|OTHER||Geometric mean ratio|145.55|||||TWO_SIDED|90.0|118.66|178.52||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||178.52|118.66|
71923513|NCT04550234|143367457|OTHER||Geometric mean ratio|52.07|||||TWO_SIDED|90.0|42.46|63.87||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||63.87|42.46|
71923514|NCT04550234|143367457|OTHER||Geometric mean ratio|101.16|||||TWO_SIDED|90.0|82.48|124.08||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.08|82.48|
71923515|NCT04550234|143367457|OTHER||Geometric mean ratio|73.34|||||TWO_SIDED|90.0|61.81|87.03||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||87.03|61.81|
71923516|NCT04550234|143367457|OTHER||Geometric mean ratio|66.33|||||TWO_SIDED|90.0|55.9|78.72||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||78.72|55.90|
71923517|NCT04550234|143367457|OTHER||Geometric mean ratio|106.58|||||TWO_SIDED|90.0|89.81|126.47||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.47|89.81|
71923518|NCT04550234|143367457|OTHER||Geometric mean ratio|86.86|||||TWO_SIDED|90.0|83.15|90.74||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||90.74|83.15|
71923519|NCT04550234|143367457|OTHER||Geometric mean ratio|92.3|||||TWO_SIDED|90.0|88.35|96.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||96.42|88.35|
71923520|NCT04550234|143367457|OTHER||Geometric mean ratio|89.54|||||TWO_SIDED|90.0|85.71|93.54||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.54|85.71|
71923521|NCT04550234|143367458|OTHER||Geometric mean ratio|102.49|||||TWO_SIDED|90.0|89.12|117.86||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||117.86|89.12|
71923522|NCT04550234|143367458|OTHER||Geometric mean ratio|144.61|||||TWO_SIDED|90.0|125.75|166.31||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||166.31|125.75|
71923523|NCT04550234|143367458|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.71|88.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.23|66.71|
71688825|NCT03782571|142893105|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|3.24|||TWO_SIDED|99.1|-1.0|17.8|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 1 - Control|Testing equivalence with respect to microsphere uptake rate.||17.8|-1.0|
71923524|NCT04550234|143367458|OTHER||Geometric mean ratio|96.19|||||TWO_SIDED|90.0|83.64|110.62||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.62|83.64|
71923525|NCT04550234|143367458|OTHER||Geometric mean ratio|89.41|||||TWO_SIDED|90.0|83.86|95.34||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||95.34|83.86|
71923526|NCT04550234|143367458|OTHER||Geometric mean ratio|94.16|||||TWO_SIDED|90.0|88.31|100.4||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.40|88.31|
71923527|NCT04550234|143367458|OTHER||Geometric mean ratio|91.7|||||TWO_SIDED|90.0|86.37|97.36||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.36|86.37|
71923528|NCT04550234|143367458|OTHER||Geometric mean ratio|91.23|||||TWO_SIDED|90.0|88.01|94.56||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||94.56|88.01|
71923529|NCT04550234|143367458|OTHER||Geometric mean ratio|99.95|||||TWO_SIDED|90.0|96.43|103.61||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||103.61|96.43|
71923530|NCT04550234|143367458|OTHER||Geometric mean ratio|90.13|||||TWO_SIDED|90.0|86.95|93.42||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.42|86.95|
71923531|NCT04550234|143367459|OTHER||Geometric mean ratio|102.91|||||TWO_SIDED|90.0|89.04|118.93||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||118.93|89.04|
71923532|NCT04550234|143367459|OTHER||Geometric mean ratio|146.57|||||TWO_SIDED|90.0|126.82|169.4||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||169.40|126.82|
71923533|NCT04550234|143367459|OTHER||Geometric mean ratio|76.72|||||TWO_SIDED|90.0|66.38|88.67||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.67|66.38|
71923534|NCT04550234|143367459|OTHER||Geometric mean ratio|95.37|||||TWO_SIDED|90.0|82.52|110.23||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||110.23|82.52|
71923535|NCT04550234|143367459|OTHER||Geometric mean ratio|82.6|||||TWO_SIDED|90.0|77.38|88.17||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||88.17|77.38|
71923536|NCT04550234|143367459|OTHER||Geometric mean ratio|87.14|||||TWO_SIDED|90.0|81.63|93.01||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.01|81.63|
71923537|NCT04550234|143367459|OTHER||Geometric mean ratio|91.45|||||TWO_SIDED|90.0|85.67|97.61||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||97.61|85.67|
71923538|NCT04550234|143367459|OTHER||Geometric mean ratio|90.91|||||TWO_SIDED|90.0|87.98|93.94||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||93.94|87.98|
71923539|NCT04550234|143367459|OTHER||Geometric mean ratio|99.37|||||TWO_SIDED|90.0|96.17|102.68||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.68|96.17|
71923540|NCT04550234|143367459|OTHER||Geometric mean ratio|89.18|||||TWO_SIDED|90.0|86.3|92.15||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||92.15|86.30|
71923541|NCT04550234|143367471|OTHER||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.13|124.49||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||124.49|94.13|
71923542|NCT04550234|143367471|OTHER||Geometric mean ratio|96.57|||||TWO_SIDED|90.0|90.96|102.53||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.53|90.96|
71923543|NCT04550234|143367471|OTHER||Geometric mean ratio|98.75|||||TWO_SIDED|90.0|95.27|102.36||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.36|95.27|
71923544|NCT04550234|143367472|OTHER||Geometric mean ratio|109.27|||||TWO_SIDED|90.0|94.55|126.29||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||126.29|94.55|
71923545|NCT04550234|143367472|OTHER||Geometric mean ratio|96.47|||||TWO_SIDED|90.0|90.38|102.97||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||102.97|90.38|
71923546|NCT04550234|143367472|OTHER||Geometric mean ratio|97.48|||||TWO_SIDED|90.0|94.34|100.73||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||100.73|94.34|
71923547|NCT04550234|143367473|OTHER||Geometric mean ratio|131.28|||||TWO_SIDED|90.0|107.03|161.02||||||"Statistical Comparison of Verinurad~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||161.02|107.03|
71923548|NCT04550234|143367473|OTHER||Geometric mean ratio|96.39|||||TWO_SIDED|90.0|81.23|114.39||||||"Statistical Comparison of Allopurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||114.39|81.23|
71923549|NCT04550234|143367473|OTHER||Geometric mean ratio|95.15|||||TWO_SIDED|90.0|91.08|99.4||||||"Statistical Comparison of Oxypurinol~Analysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect"||99.40|91.08|
71923550|NCT00224952|143367475|OTHER|||||||0.004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.004
71923551|NCT00224952|143367475|OTHER|||||||0.032|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (4-Methylthio-2-hydroxyiminostilbene) as a function of age||||0.032
71923552|NCT00224952|143367475|OTHER|||||||0.018|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Fractional Recovery (MTHIS)) as a function of age||||0.018
71923553|NCT00224952|143367475|OTHER|||||||0.033|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery MTHIS)) as a function of age||||0.033
71923554|NCT00224952|143367475|OTHER|||||||0.0004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-3-ene VPA isomers)) as a function of age||||0.0004
71923555|NCT00224952|143367475|OTHER|||||||0.0003|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-2-ene VPA) ) as a function of age||||0.0003
71923556|NCT00224952|143367475|OTHER||||||<|0.0001|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Total N-acetylcysteine conjugates) as a function of age||||<0.0001
71923557|NCT00224952|143367475|OTHER|||||||0.522|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-3-ene VPA isomers)) as a function of age||||0.522
71923558|NCT00224952|143367475|OTHER|||||||0.925|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-2-ene VPA) ) as a function of age||||0.925
71923559|NCT00224952|143367475|OTHER|||||||0.469|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery Total NAC conjugates) as a function of age||||0.469
71923560|NCT01928758|143367476|OTHER||Mean Difference (Final Values)|-175.7|||<|0.0001|TWO_SIDED|95.0|-218.3|-133.1||Complete case analysis|Regression, Linear|Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||-133.1|-218.3|<0.0001
71688826|NCT03782571|142893105|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|4.95|||TWO_SIDED|99.1|-7.8|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-7.8|
71761091|NCT02840461|143023772|EQUIVALENCE|Therapeutic equivalence of the Test product to the Reference product based on the primary endpoint was evaluated in the PP population. If the confidence interval is within 80-125% for the primary endpoint, then the Test and Reference treatments are considered therapeutically equivalent.|Mean Difference (Net)|103.51|||||TWO_SIDED|90.0|97.95|110.0||||||||110.00|97.95|
71923561|NCT01928758|143367477|OTHER||Mean Difference (Final Values)|0.69||||0.16|TWO_SIDED|95.0|-0.28|1.65||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.65|-0.28|0.16
71923562|NCT01928758|143367478|OTHER||Mean Difference (Final Values)|0.38||||0.67|TWO_SIDED|95.0|-1.4|2.16||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.|||2.16|-1.40|0.67
71923563|NCT01928758|143367479|OTHER||Mean Difference (Final Values)|-0.31||||0.65|TWO_SIDED|95.0|-1.68|1.05||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group|||1.05|-1.68|0.65
71923564|NCT02681094|143367487|SUPERIORITY||LS mean difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.55|-0.24|||Mixed Models Analysis|||||-0.24|-0.55|<0.0001
71923565|NCT02681094|143367487|SUPERIORITY||LS mean difference|-0.34|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.19|||Mixed Models Analysis|||||-0.19|-0.50|<0.0001
71923566|NCT02681094|143367488|SUPERIORITY||Risk Difference (RD)|19.8|||<|0.0001|TWO_SIDED|95.0|12.7|26.9|||Method of Zhang, Tsiatis, and Davidian|||||26.9|12.7|<0.0001
71923567|NCT02681094|143367488|SUPERIORITY||Risk Difference (RD)|11.7||||0.0018|TWO_SIDED|95.0|4.4|19.1|||Method of Zhang, Tsiatis, and Davidian|||||19.1|4.4|0.0018
71923568|NCT02681094|143367489|SUPERIORITY||LS mean difference|-7.58||||0.0135|TWO_SIDED|95.0|-13.59|-1.57|||Mixed Models Analysis|||||-1.57|-13.59|0.0135
71923569|NCT02681094|143367489|SUPERIORITY||LS mean difference|-14.88|||<|0.0001|TWO_SIDED|95.0|-20.85|-8.91|||Mixed Models Analysis|||||-8.91|-20.85|<0.0001
71923570|NCT02681094|143367490|SUPERIORITY||LS mean difference|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.11|-1.09|||Mixed Models Analysis|||||-1.09|-2.11|<0.0001
71923571|NCT01270139|143367506|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
71923572|NCT01270139|143367507|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71923573|NCT01270139|143367508|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control||||<0.05
71923574|NCT01270139|143367509|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
71688827|NCT03782571|142893105|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|2.9|STANDARD_ERROR_OF_MEAN|6.22|||TWO_SIDED|99.1|-15.1|20.9|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Control|Testing equivalence with respect to microsphere uptake rate.||20.9|-15.1|
71688828|NCT03782571|142893105|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.13|||TWO_SIDED|99.1|-20.4|9.4|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 1|Testing equivalence with respect to microsphere uptake rate.||9.4|-20.4|
71688829|NCT03782571|142893105|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-3.7|STANDARD_ERROR_OF_MEAN|3.1|||TWO_SIDED|99.1|-12.6|5.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 3 - Test 2|Testing equivalence with respect to microsphere uptake rate.||5.3|-12.6|
71688830|NCT03782571|142893105|EQUIVALENCE|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|4.18|||TWO_SIDED|99.1|-13.9|10.3|||Mixed Models Analysis|Kenward and Roger method was used for denominator degrees of freedom. Adjustment was made using a simulation-based approach.|Test 2 - Test 1|Testing equivalence with respect to microsphere uptake rate.||10.3|-13.9|
71688831|NCT03188523|142893113|SUPERIORITY||Posterior Mean Difference|-1.03|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>98%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
71688832|NCT03188523|142893113|SUPERIORITY||Posterior Mean Difference|-0.92|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was \>95%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).||||
71688833|NCT03188523|142893129|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
71688834|NCT03188523|142893129|OTHER||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.||||
71761092|NCT02840461|143023772|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0027|TWO_SIDED|95.0|-16.24|-3.42|||ANOVA|||||-3.42|-16.24|0.0027
71923575|NCT01270139|143367510|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
71923576|NCT01270139|143367511|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|ONE_SIDED||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
71923577|NCT01270139|143367512|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
71923578|NCT01270139|143367513|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
71923579|NCT01270139|143367514|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED||||||Chi-squared|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control||||<0.05
71923580|NCT01270139|143367515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control||||<0.05
71923581|NCT01270139|143367516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
71923582|NCT01270139|143367517|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and Stenting control||||<0.05
71923583|NCT01270139|143367518|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|TWO_SIDED|||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control||||<0.05
71923584|NCT01270139|143367519|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71923585|NCT01270139|143367520|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71923586|NCT01270139|143367521|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71923587|NCT01270139|143367522|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.||||<0.05
71923588|NCT01270139|143367523|OTHER|The Kolmogorov-Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher's exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher's post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was \>0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|t-test, 2 sided|||Null hypothesis is ex-vivo arm with exposure of nanoparticles is superior to saline control.||||<0.05
71923589|NCT00134563|143367524|SUPERIORITY_OR_OTHER||Relative risk reduction (%)|31.5||||0.0005||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 14 mg compared to placebo|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was sized to detect a 25% relative risk reduction with teriflunomide in the 2-year relapse rate at a significance level of 0.050 with a power ≥95% anticipating a potential 20% 2-year dropout rate."||||0.0005
71923590|NCT00134563|143367524|SUPERIORITY_OR_OTHER||Relative Risk Reduction (%)|31.2||||0.0002||||||"Step down approach used to adjust for multiplicity:~* H1 tested first~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 7 mg compared to placebo|||||0.0002
71923591|NCT00134563|143367525|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|29.8||||0.0279||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~* H1: No difference between Teriflunomide 14 mg and placebo~* H2: No difference between Teriflunomide 7 mg and placebo~The study was also sized to detect a 37% hazard rate reduction of an assumed disability progression hazard rate of 0.1783 in the placebo group and 0.1116 in the teriflunomide group by the end of 2 years with a power of 80% anticipating a potential 20% 2-year dropout rate."||||0.0279
71923592|NCT00134563|143367525|SUPERIORITY_OR_OTHER||Hazard ratio reduction (%)|23.7||||0.0835||||||"Step down approach:~* H1 tested only if both comparisons on the primary outcome measure were statistically significant~* H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|||||0.0835
71923593|NCT00134563|143367526|SUPERIORITY_OR_OTHER|||||||0.0003||95.0||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0003
71923594|NCT00134563|143367526|SUPERIORITY_OR_OTHER|||||||0.0317||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures \[MMRM\] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).||||0.0317
71923595|NCT00134563|143367529|SUPERIORITY_OR_OTHER|||||||0.8271||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.8271
71923596|NCT00134563|143367529|SUPERIORITY_OR_OTHER|||||||0.3861||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||||||0.3861
71761093|NCT02840461|143023772|SUPERIORITY||Mean Difference (Net)|-9.83||||0.0028|TWO_SIDED|95.0|-16.25|-3.4|||ANOVA|||||-3.40|-16.25|0.0028
71923597|NCT02452320|143367534|OTHER|||||||0.59|||||||t-test, 2 sided|||||||0.59
71923598|NCT03382639|143367560|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.66||0.426|TWO_SIDED|95.0|-1.4|1.2|||Mixed Models Analysis|||||1.2|-1.4|0.426
71923599|NCT03382639|143367560|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.66||0.725|TWO_SIDED|95.0|-1.5|1.1|||Mixed Models Analysis|||||1.1|-1.5|0.725
71923600|NCT03382639|143367560|SUPERIORITY||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.68||0.808|TWO_SIDED|95.0|-0.7|1.9|||Mixed Models Analysis|||||1.9|-0.7|0.808
71923601|NCT01072175|143367584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.79|1.34|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.|||1.34|0.79|
71923602|NCT01072175|143367584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.99|||||TWO_SIDED|90.0|0.78|1.25|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.78|
71923603|NCT01072175|143367584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.27|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.|||1.27|0.84|
71923604|NCT01072175|143367584|NON_INFERIORITY_OR_EQUIVALENCE|Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.98|||||TWO_SIDED|90.0|0.66|1.45|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.|||1.45|0.66|
71923605|NCT01072175|143367585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.01|||||TWO_SIDED|90.0|0.85|1.19|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.19|0.85|
71923606|NCT01072175|143367585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.82|1.08|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.|||1.08|0.82|
71923607|NCT01072175|143367585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.84|1.25|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2285403 were calculated.|||1.25|0.84|
71923608|NCT01072175|143367585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-inf) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.92|||||TWO_SIDED|90.0|0.81|1.03|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for GSK2285403 were calculated.|||1.03|0.81|
71923609|NCT01072175|143367585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.81|1.29|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2298683 were calculated.|||1.29|0.81|
71923610|NCT01072175|143367585|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-t) of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||TWO_SIDED|90.0|0.76|1.37|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2167542 were calculated.|||1.37|0.76|
71923611|NCT01072175|143367592|SUPERIORITY_OR_OTHER||Unconditional exact method|-4.0|||||TWO_SIDED|95.0|-23.1|15.9||||||Difference in response rate Arm2 - Arm1||15.9|-23.1|
71923612|NCT01072175|143367592|SUPERIORITY_OR_OTHER||Unconditional exact method|22.0|||||TWO_SIDED|95.0|2.5|40.7||||||Difference in response rate Arm3 - Arm1||40.7|2.5|
71923613|NCT01072175|143367593|SUPERIORITY_OR_OTHER||Unconditional exact method|-6.0|||||TWO_SIDED|95.0|-24.9|14.1||||||Difference in response rate Arm2- Arm1||14.1|-24.9|
71923614|NCT01072175|143367593|SUPERIORITY_OR_OTHER||Unconditional exact method|15.0|||||TWO_SIDED|95.0|-4.9|33.7||||||Difference in response rate Arm3 - Arm1||33.7|-4.9|
71923615|NCT01072175|143367594|SUPERIORITY_OR_OTHER||Response rate|6.0|||||TWO_SIDED|95.0|5.1|26.8||||||||26.8|5.1|
71923616|NCT01072175|143367595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58||||0.0048|TWO_SIDED|95.0|0.38|0.87|||Log Rank||HRs were estimated using the Pike estimator.|||0.87|0.38|0.0048
71923617|NCT01072175|143367595|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Log Rank||HRs were estimated using the Pike estimator.|||0.68|0.29|<0.0001
71923618|NCT01072175|143367597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.1667|TWO_SIDED|95.0|0.45|1.18|||Log Rank||HRs were estimated using the Pike estimator.|||1.18|0.45|0.1667
71923619|NCT01072175|143367597|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.54||||0.0119|TWO_SIDED|95.0|0.32|0.9|||Log Rank||HRs were estimated using the Pike estimator.|||0.90|0.32|0.0119
71923620|NCT01072175|143367605|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.51|||||TWO_SIDED|90.0|1.1|2.08|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||2.08|1.10|
71688835|NCT03498313|142893158|SUPERIORITY||Slope|-0.25|STANDARD_ERROR_OF_MEAN|0.082||0.002|TWO_SIDED|95.0|-0.41|-0.08|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo represents the reference treatment.|Fixed interaction effect of treatment (0=Placebo, 1=E2) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||-.08|-.41|.002
71688836|NCT03498313|142893158|SUPERIORITY||Slope|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.46|TWO_SIDED|95.0|-0.22|0.1|||Mixed Models Analysis|This is the p-value for the Treatment X Cycle Phase Interaction. Kenward-Roger Method was utilized for degrees of freedom.|Placebo Represents the Reference Condition.|Fixed interaction effect of treatment (0=Placebo, 1=P4) by cycle phase (0=Lower-Risk Early Luteal Baseline, 1=Higher-Risk Perimenstrual Phase) predicting SI severity in a multilevel model (with daily observations nested within conditions nested within participants over time).||.10|-.22|.46
71688837|NCT02171429|142893163|SUPERIORITY||Difference in Remission Rates|7.2||||0.1729|TWO_SIDED|95.0|-3.83|16.12||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||16.12|-3.83|0.1729
71923621|NCT01072175|143367607|NON_INFERIORITY_OR_EQUIVALENCE|Following loge transformation, AUC(0-tau) of dabrafenib was analyzed by a linear mixed effect model with dosing chort and day as fixed effects and subject as random effect. Based on the model, geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|Geometric Mean Ratio|1.23|||||TWO_SIDED|90.0|0.89|1.69|||||Geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|||1.69|0.89|
71923622|NCT01072175|143367607|NON_INFERIORITY_OR_EQUIVALENCE|Following loge tranformation, AUC(0-tau) of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5, 2 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were then provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.1|||||TWO_SIDED|90.0|0.84|1.44|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|||1.44|0.84|
71923623|NCT00218439|143367644|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71923624|NCT00218439|143367645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||||||0.006
71923625|NCT00218439|143367646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|||||||Mixed Models Analysis|||||||0.56
71758604|NCT00836693|143019584|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|STANDARD_ERROR_OF_MEAN|3.11|>|0.001|TWO_SIDED|95.0|13.9|26.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANOVA|||The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||26.1|13.9|>0.001
71923626|NCT00218439|143367647|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|||||||Mixed Models Analysis|||||||0.33
71923627|NCT00218439|143367648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|||||||Mixed Models Analysis|||||||0.82
71923628|NCT01474291|143367684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.56||||0.023|TWO_SIDED|95.0|1.06|2.3|||Wald Chi-square|Wald Chi-square Test for Type 3 generalized estimating equation (GEE) Analysis.||"Influence of baseline factor Patient's Age (\>=65) upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||2.30|1.06|0.0230
71923629|NCT01474291|143367684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.92|8.43|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor No methotrexate (MTX) sequences within the two last years upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||8.43|3.92|<0.0001
71923630|NCT01474291|143367684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.03||||0.0212|TWO_SIDED|95.0|1.11|3.7|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Past history of severe infectious disease upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."||3.70|1.11|0.0212
71923631|NCT01474291|143367684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0076|TWO_SIDED|95.0|1.05|1.41|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Higher Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) (unit=1) on physician decision to initiate tocilizumab monotherapy; DAS28-ESR was calculated from the number of swollen joints and tender joints using 28-joint count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity; scores range from 0 to 10; higher scores correspond to greater disease activity (multivariate analysis)."||1.41|1.05|0.0076
71923632|NCT00148109|143367709|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Fisher Exact|||Estimate a 4 month progression-free survival rate for each group.||||<0.05
71923633|NCT02735382|143367736|SUPERIORITY||Odds Ratio (OR)|4.663|||<|0.0001|TWO_SIDED|95.0|4.116|5.283|||Chi-squared, Corrected|||||5.283|4.116|<.0001
71923634|NCT02735382|143367737|SUPERIORITY||Odds Ratio (OR)|3.284|||<|0.0001|TWO_SIDED|95.0|2.672|4.035|||Chi-squared, Corrected|||||4.035|2.672|<.0001
71923635|NCT02735382|143367738|SUPERIORITY||Odds Ratio (OR)|0.885||||0.8438|TWO_SIDED|95.0|0.42|1.698|||Chi-squared, Corrected|||||1.698|0.420|.8438
71923636|NCT02735382|143367739|SUPERIORITY||Mean Difference (Final Values)|0.44|STANDARD_ERROR_OF_MEAN|0.161||0.007|TWO_SIDED|95.0|0.123|0.757|||t-test, 2 sided|df=292||A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.||0.757|0.123|.007
71923637|NCT05489146|143367740|SUPERIORITY|||||||0.046|||||||Mixed Models Analysis|||||||0.046
71761094|NCT02840461|143023773|EQUIVALENCE|If the 90% confidence interval (with Yates correction) for the difference between the proportion of patients in the Test and Reference groups considered to be a clinical success was contained within the pre-defined equivalence limits \[-20%, +20%\], the therapeutic equivalence of the Test to Reference product was considered supported.|Mean Difference (Net)|5.8|||||TWO_SIDED|90.0|-2.7|14.2||||||||14.2|-2.7|
71923638|NCT05489146|143367741|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|||||||0.003
71923639|NCT05489146|143367742|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71923640|NCT05489146|143367743|SUPERIORITY||||||>|0.05|||||||ANCOVA|||||||>0.05
71923641|NCT05489146|143367744|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71923642|NCT05489146|143367745|SUPERIORITY||||||>|0.05|||||||Mixed Models Analysis|||||||>0.05
71923643|NCT05489146|143367746|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71923644|NCT05489146|143367747|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71923645|NCT00078715|143367765|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.004|STANDARD_ERROR_OF_MEAN|1.141||0.527|TWO_SIDED|95.0|-4.26|2.251||The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.|Mixed Models Analysis|A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.||The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.||2.251|-4.260|.527
71923646|NCT00643851|143367769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|0.1243|<|0.0001|TWO_SIDED|95.0|-1.11|-0.62||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET was superior to both controls.|ANCOVA|||||-0.62|-1.11|<0.0001
71923647|NCT00643851|143367769|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.1245|<|0.0001|TWO_SIDED|95.0|-0.94|-0.45||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.45|-0.94|<0.0001
71923648|NCT00643851|143367770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|3.883|<|0.0001|TWO_SIDED|95.0|-26.7|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-11.4|-26.7|<0.0001
71923649|NCT00643851|143367770|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-27.5|STANDARD_ERROR_OF_MEAN|3.897|<|0.0001|TWO_SIDED|95.0|-35.1|-19.8||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-19.8|-35.1|<0.0001
71923650|NCT00643851|143367771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.9|STANDARD_ERROR_OF_MEAN|4.633|<|0.0001|TWO_SIDED|95.0|20.8|39.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|modified logistic regression|||||39.0|20.8|<0.0001
71923651|NCT00643851|143367771|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|4.947||0.0003|TWO_SIDED|95.0|8.1|27.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||27.4|8.1|0.0003
71923652|NCT00643851|143367772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.34|STANDARD_ERROR_OF_MEAN|0.1938|<|0.0001|TWO_SIDED|95.0|-1.72|-0.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.96|-1.72|<0.0001
71923653|NCT00643851|143367772|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|0.1912|<|0.0001|TWO_SIDED|95.0|-1.57|-0.82||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.82|-1.57|<0.0001
71923654|NCT00643851|143367773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.3388||0.8769|TWO_SIDED|95.0|-0.72|0.61||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.61|-0.72|0.8769
71923655|NCT00643851|143367773|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.37|STANDARD_ERROR_OF_MEAN|0.3399|<|0.0001|TWO_SIDED|95.0|-2.04|-0.71||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.71|-2.04|<0.0001
71923656|NCT00643851|143367774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.4191|||TWO_SIDED|95.0|-0.98|0.66||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||0.66|-0.98|
71923657|NCT00643851|143367774|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.57|STANDARD_ERROR_OF_MEAN|0.4201|||TWO_SIDED|95.0|-2.4|-0.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA|||||-0.74|-2.40|
71923658|NCT04557189|143367779|SUPERIORITY||Adjusted Treatment Difference|0.241|||||TWO_SIDED|95.0|0.031|0.452|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.452|0.031|
71923659|NCT04557189|143367780|SUPERIORITY||Adjusted Treatment Difference|0.175|||||TWO_SIDED|95.0|-0.044|0.394|||||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on Cochran-Mantel-Haenszel (CMH) method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|0.394|-0.044|
71688838|NCT02171429|142893164|SUPERIORITY||Difference in Remission Rates|-6.8||||0.1458|TWO_SIDED|95.0|-16.26|2.73||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.73|-16.26|0.1458
71688839|NCT02171429|142893165|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
71688840|NCT02171429|142893166|SUPERIORITY||Difference in Response Rates|14.0||||0.1729|TWO_SIDED|95.0|-0.12|27.19||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||27.19|-0.12|0.1729
71688841|NCT02171429|142893166|SUPERIORITY||Difference in Response Rates|-2.5||||0.6726|TWO_SIDED|95.0|-13.83|9.01||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.01|-13.83|0.6726
71761095|NCT04672655|143023803|OTHER|||||||0.8875||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.8875
71923660|NCT04557189|143367781|SUPERIORITY||Adjusted Treatment Difference|-0.094|||||TWO_SIDED|95.0|-0.253|0.059|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.059|-0.253|
71923661|NCT04557189|143367782|SUPERIORITY||Adjusted Treatment Difference|-0.141|||||TWO_SIDED|95.0|-0.316|0.033|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.033|-0.316|
71923662|NCT04557189|143367783|SUPERIORITY||Adjusted Treatment Difference|0.191|||||TWO_SIDED|95.0|-0.029|0.41|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.410|-0.029|
71923663|NCT04557189|143367784|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
71923664|NCT04557189|143367785|SUPERIORITY||Adjusted Treatment Difference|-0.234|||||TWO_SIDED|95.0|-0.448|-0.019|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||-0.019|-0.448|
71923665|NCT04557189|143367786|SUPERIORITY||Hazard Ratio (HR)|0.393|||||TWO_SIDED|95.0|0.122|1.259|||||The hazard ratio is derived from a Cox proportional hazard model with treatment group and the number of Apfel risk factors (3 or 4) as independent variables.|||1.259|0.122|
71923666|NCT04557189|143367787|SUPERIORITY||Difference in LSM Estimates|0.188|||||TWO_SIDED|95.0|-0.402|0.777||||||30 Minutes Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.777|-0.402|
71923667|NCT04557189|143367787|SUPERIORITY||Difference in LSM Estimates|0.401|||||TWO_SIDED|95.0|-0.258|1.059||||||1 Hour Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|1.059|-0.258|
71923668|NCT04557189|143367787|SUPERIORITY||Difference in LSM Estimates|0.265|||||TWO_SIDED|95.0|0.0|0.786||||||2 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.786|0|
71923669|NCT04557189|143367787|SUPERIORITY||Difference in LSM Estimates|0.097|||||TWO_SIDED|95.0|-0.093|0.286||||||6 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.286|-0.093|
71923670|NCT04557189|143367787|SUPERIORITY||Difference in LSM Estimates|-0.203|||||TWO_SIDED|95.0|-0.575|0.17||||||24 Hours Post Surgery|From MMRM analysis over all post-randomization timepoints, with the Peak VRS score as the outcome, treatment group, timepoint, number of Apfel risk factors and treatment-by-timepoint interaction as fixed effects and participant as random effect with unstructured covariance structure for observed data up to 24 hours post surgery.|0.170|-0.575|
71923671|NCT04557189|143367788|SUPERIORITY||Adjusted Treatment Difference|0.146|||||TWO_SIDED|95.0|-0.073|0.365|||||Adjusted treatment difference between TAK-951, ondansetron, associated confidence intervals: based on CMH method, adjusting for number of Apfel risk factors (3/4), or exact unconditional confidence limits for treatment difference if numerator is ≤5.|||0.365|-0.073|
71923672|NCT01731600|143367807|OTHER||Incidence rate|0.0|||||ONE_SIDED|97.5||0.067|||||The incidence of inhibitory antibodies was calculated as number of patients with inhibitors during the main phase of the trial divided by number of patients in the main phase of the trial.|A one-sided, upper 97.5% confidence limit was provided based on an exact calculation in the binomial distribution.||0.067||
71923673|NCT00465894|143367824|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
71923674|NCT01728454|143368013|SUPERIORITY|||||||0.036|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.0360
71923675|NCT01728454|143368013|SUPERIORITY|||||||0.1087|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1087
71923676|NCT01728454|143368013|SUPERIORITY|||||||0.2263|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.2263
71923677|NCT01728454|143368013|SUPERIORITY|||||||0.5375|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5375
71923678|NCT01728454|143368014|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1017
71923679|NCT01728454|143368014|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.1927
71923680|NCT01728454|143368014|SUPERIORITY|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1017
71923681|NCT01728454|143368014|SUPERIORITY|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.1927
71923682|NCT01728454|143368015|SUPERIORITY|||||||0.7508|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.7508
71923683|NCT01728454|143368015|SUPERIORITY|||||||0.5507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1||||0.5507
71923684|NCT01728454|143368015|SUPERIORITY|||||||0.3993|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.3993
71923685|NCT01728454|143368015|SUPERIORITY|||||||0.5821|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1||||0.5821
71923686|NCT01728454|143368016|SUPERIORITY|||||||0.7507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.7507
71923687|NCT01728454|143368016|SUPERIORITY|||||||0.8919|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.8919
71923688|NCT01728454|143368017|SUPERIORITY|||||||0.478|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.4780
71923689|NCT01728454|143368017|SUPERIORITY|||||||0.2354|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2354
71923690|NCT01728454|143368018|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
71923691|NCT01728454|143368018|SUPERIORITY|||||||0.1636|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1636
71923692|NCT01728454|143368019|SUPERIORITY|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1140
71923693|NCT01728454|143368019|SUPERIORITY|||||||0.0733|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0733
71923694|NCT01728454|143368020|SUPERIORITY|||||||0.1253|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.1253
71923695|NCT01728454|143368020|SUPERIORITY|||||||0.3442|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.3442
71923696|NCT01728454|143368021|SUPERIORITY|||||||0.0303|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.0303
71923697|NCT01728454|143368021|SUPERIORITY|||||||0.2864|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle||||0.2864
71923698|NCT01728454|143368022|SUPERIORITY|||||||0.4365|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.4365
71923699|NCT01728454|143368022|SUPERIORITY|||||||0.1302|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1||||0.1302
71923700|NCT01728454|143368022|SUPERIORITY|||||||0.3591|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.3591
71923701|NCT01728454|143368022|SUPERIORITY|||||||0.0872|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1||||0.0872
71923702|NCT01728454|143368022|SUPERIORITY|||||||0.4814|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.4814
71923703|NCT01728454|143368022|SUPERIORITY|||||||0.9162|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1||||0.9162
71923704|NCT01728454|143368022|SUPERIORITY|||||||0.6607|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.6607
71923705|NCT01728454|143368022|SUPERIORITY|||||||0.9527|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1||||0.9527
71923706|NCT01728454|143368023|SUPERIORITY|||||||0.2812|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.2812
71923707|NCT01728454|143368023|SUPERIORITY|||||||0.5858|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1||||0.5858
71923708|NCT01728454|143368023|SUPERIORITY|||||||0.4116|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4116
71923709|NCT01728454|143368023|SUPERIORITY|||||||0.4252|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1||||0.4252
71923710|NCT01728454|143368024|SUPERIORITY|||||||0.6131|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.6131
71923711|NCT01728454|143368024|SUPERIORITY|||||||0.7881|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1||||0.7881
71923712|NCT01728454|143368024|SUPERIORITY|||||||0.9376|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.9376
71923713|NCT01728454|143368024|SUPERIORITY|||||||0.6552|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1||||0.6552
71923714|NCT01728454|143368024|SUPERIORITY|||||||0.7143|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.7143
71923715|NCT01728454|143368024|SUPERIORITY|||||||0.2985|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1||||0.2985
71923716|NCT01728454|143368024|SUPERIORITY|||||||0.3162|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.3162
71923717|NCT01728454|143368024|SUPERIORITY|||||||0.7503|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1||||0.7503
71923718|NCT01190839|143368025|SUPERIORITY_OR_OTHER|||||||0.097||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.097
71923719|NCT01190839|143368026|SUPERIORITY_OR_OTHER||||||<|0.001||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||<0.001
71923720|NCT01190839|143368027|SUPERIORITY_OR_OTHER|||||||0.098||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test|||||||0.098
71923721|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.001
71923722|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.001
71923723|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.001
71923724|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.001
71923725|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
71923726|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.001
71923727|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.001
71923728|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.001
71923729|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
71923730|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
71923731|NCT01362062|143368055|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
71923732|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.003|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 3.||||=0.003
71923733|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.005|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 4.||||=0.005
71923734|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 5.||||=0.002
71923735|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 6.||||=0.014
71923736|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 7.||||=0.001
71688842|NCT02171429|142893167|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
71688843|NCT02171429|142893168|SUPERIORITY||Difference in Response Rates|9.4||||0.2372|TWO_SIDED|95.0|-4.31|21.95||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||21.95|-4.31|0.2372
71688844|NCT02171429|142893168|SUPERIORITY||Difference in Response Rates|-3.5||||0.5341|TWO_SIDED|95.0|-14.76|7.82||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.82|-14.76|0.5341
71688845|NCT02171429|142893169|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
71688846|NCT02171429|142893170|SUPERIORITY||Difference in Remission Rates|11.2||||0.2372|TWO_SIDED|95.0|0.59|19.76||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||19.76|0.59|0.2372
71923737|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.008|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 8.||||=0.008
71923738|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.014|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 9.||||=0.014
71923739|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.009|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 10.||||=0.009
71923740|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 11.||||=0.001
71923741|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 12.||||=0.001
71923742|NCT01362062|143368056|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Paired t-test|||Statistical analysis for CFB at Visit 13.||||=0.001
71923743|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.002
71923744|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
71923745|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.002|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.002
71923746|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
71923747|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
71923748|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
71923749|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
71923750|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
71923751|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
71923752|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
71923753|NCT01362062|143368057|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
71923754|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
71923755|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
71923756|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
71923757|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
71923758|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
71923759|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
71923760|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
71923761|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
71923762|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
71923763|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
71923764|NCT01362062|143368058|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
71923765|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.001
71923766|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.001
71923767|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.001
71923768|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.001
71923769|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.||||=0.001
71923770|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.001
71923771|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.001
71923772|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.001
71923773|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.001
71923774|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.001
71923775|NCT01362062|143368059|SUPERIORITY_OR_OTHER||||||=|0.001|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.001
71923776|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.064|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.||||=0.064
71923777|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.104|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.||||=0.104
71923778|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.052|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.||||=0.052
71923779|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.043|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.||||=0.043
71923780|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.015|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB of Visit 7.||||=0.015
71923781|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.||||=0.023
71923782|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.028|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.||||=0.028
71923783|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.048|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.||||=0.048
71923784|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.025|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.||||=0.025
71923785|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.023|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.||||=0.023
71923786|NCT01362062|143368060|SUPERIORITY_OR_OTHER||||||=|0.022|TWO_SIDED||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.||||=0.022
71923787|NCT00950755|143368068|SUPERIORITY_OR_OTHER||percentage of participants|76.0|||||TWO_SIDED|95.0|62.0|89.0|||||The estimated value represents the percentage of participants with response.|||89|62|
71923788|NCT00950755|143368069|SUPERIORITY_OR_OTHER||percentage of participants|54.0|||||TWO_SIDED|95.0|38.0|69.0|||||The estimated value represents the percentage of participants with confirmed response.|||69|38|
71923789|NCT00950755|143368070|SUPERIORITY_OR_OTHER||percentage of participants|34.0|||||TWO_SIDED|95.0|20.0|49.0|||||The estimated value represents the percentage of participants with confirmed CR.|||49|20|
71923790|NCT00950755|143368071|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||||TWO_SIDED|95.0|26.0|57.0|||||The estimated value represents the percentage of participants with confirmed CR + CCR.|||57|26|
71923791|NCT00950755|143368072|SUPERIORITY_OR_OTHER||percentage of participants|10.0|||||TWO_SIDED|95.0|1.0|19.0|||||The estimated value represents the percentage of participants with confirmed PR.|||19|1|
71923792|NCT02549040|143368089|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.85|1.09||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.09|0.85|
71923793|NCT02549040|143368089|OTHER||Geometric mean ratio|1.13|||||TWO_SIDED|90.0|1.02|1.26||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.26|1.02|
71923794|NCT02549040|143368089|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.88|1.11||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.11|0.88|
71923795|NCT02549040|143368089|OTHER||Geometric mean ratio|0.89|||||TWO_SIDED|90.0|0.8|0.99||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.99|0.80|
71923796|NCT02549040|143368090|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.98||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.98|0.79|
71923797|NCT02549040|143368090|OTHER||Geometric mean ratio|1.09|||||TWO_SIDED|90.0|0.98|1.21||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.21|0.98|
71923798|NCT02549040|143368090|OTHER||Geometric mean ratio|0.9|||||TWO_SIDED|90.0|0.81|1.0||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.00|0.81|
71923799|NCT02549040|143368090|OTHER||Geometric mean ratio|0.88|||||TWO_SIDED|90.0|0.79|0.97||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.97|0.79|
71688847|NCT02171429|142893170|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1192|TWO_SIDED|95.0|-17.2|2.33||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.33|-17.20|0.1192
71688848|NCT02171429|142893171|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
71688849|NCT02171429|142893172|SUPERIORITY||Difference in Remission Rates|9.6||||0.2729|TWO_SIDED|95.0|-4.71|22.02||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.02|-4.71|0.2729
71688850|NCT02171429|142893172|SUPERIORITY||Difference in Remission Rates|-14.8||||0.0215|TWO_SIDED|95.0|-26.97|-2.04||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-2.04|-26.97|0.0215
71688851|NCT02171429|142893173|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
71688852|NCT02171429|142893174|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
71923800|NCT02549040|143368091|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.61|0.82||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.82|0.61|
71923801|NCT02549040|143368091|OTHER||Geometric mean ratio|0.87|||||TWO_SIDED|90.0|0.75|1.01||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.01|0.75|
71761181|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.3613|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.3|0.3613
71923802|NCT02549040|143368091|OTHER||Geometric mean ratio|0.7|||||TWO_SIDED|90.0|0.6|0.81||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.81|0.60|
71923803|NCT02549040|143368091|OTHER||Geometric mean ratio|0.76|||||TWO_SIDED|90.0|0.66|0.86||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.86|0.66|
71923804|NCT02549040|143368092|OTHER||Geometric mean ratio|0.82|||||TWO_SIDED|90.0|0.72|0.93||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.93|0.72|
71688853|NCT02171429|142893174|SUPERIORITY|||||||0.2864||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.2864
71688854|NCT02171429|142893175|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71688855|NCT02171429|142893176|SUPERIORITY|||||||0.1729||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.1729
71688856|NCT02171429|142893176|SUPERIORITY|||||||0.4174||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.4174
71688857|NCT02171429|142893177|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71688858|NCT02171429|142893178|SUPERIORITY||Mean Difference (Net)|-1.1||||0.1659|TWO_SIDED|95.0|-2.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-2.8|0.1659
71688859|NCT02171429|142893178|SUPERIORITY||Mean Difference (Net)|0.1||||0.9182|TWO_SIDED|95.0|-1.3|1.4||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||1.4|-1.3|0.9182
71688860|NCT02171429|142893179|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
71688861|NCT02171429|142893179|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
71923805|NCT02549040|143368092|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.94|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.94|
71923806|NCT02549040|143368092|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.96||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.76|
71923807|NCT02549040|143368092|OTHER||Geometric mean ratio|0.83|||||TWO_SIDED|90.0|0.74|0.94||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.74|
71923808|NCT02549040|143368095|OTHER||Geometric mean ratio|0.84|||||TWO_SIDED|90.0|0.75|0.94||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.94|0.75|
71923809|NCT02549040|143368095|OTHER||Geometric mean ratio|1.06|||||TWO_SIDED|90.0|0.95|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||1.18|0.95|
71923810|NCT02549040|143368095|OTHER||Geometric mean ratio|0.85|||||TWO_SIDED|90.0|0.76|0.95||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.95|0.76|
71923811|NCT02549040|143368095|OTHER||Geometric mean ratio|0.86|||||TWO_SIDED|90.0|0.77|0.96||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet||0.96|0.77|
71923812|NCT00421928|143368122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.18|<|0.05||95.0|-1.04|-0.33|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and pooled analysis center as factors and baseline pain intensity score as a covariate.||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.||-0.33|-1.04|<0.05
71923813|NCT02022566|143368129|OTHER||||||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71923814|NCT02022566|143368130|OTHER|Described elsewhere|Mean Difference (Final Values)|0.05|||<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71923815|NCT03799198|143368136|SUPERIORITY||Treatment Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.02|<|0.001|TWO_SIDED|95.0|-5.51|-1.5|||ANCOVA|||Analysis of in-trial data with missing observations for body weight at month 12 imputed from the WMP arm based on a jump to reference multiple (x=100) imputation approach. Percent change in body weight from baseline to month 12 was calculated for each study participant within the FAS and analyzed using an analysis of covariance model with randomized treatment as a factor and baseline body weight (kg) as a covariate.||-1.50|-5.51|<0.001
71923816|NCT00665366|143368181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.058|TWO_SIDED|95.0|-4.14|0.07|||ANCOVA|||||0.07|-4.14|0.058
71923817|NCT00665366|143368182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.669|TWO_SIDED|95.0|-0.16|0.25|||ANOVA/ANCOVA||Week 3|||0.25|-0.16|0.669
71923818|NCT00665366|143368182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.436|TWO_SIDED|95.0|-0.36|0.16|||ANOVA/ANCOVA||Week 6|||0.16|-0.36|0.436
71923819|NCT00665366|143368182|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.053|TWO_SIDED|95.0|-0.56|0.0|||ANOVA/ANCOVA||Week 9|||0.00|-0.56|0.053
71923820|NCT00665366|143368182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.044|TWO_SIDED|95.0|-0.59|-0.01|||ANOVA/ANCOVA||Week 12|||-0.01|-0.59|0.044
71923821|NCT00665366|143368183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.24|TWO_SIDED|95.0|-0.22|0.06|||ANOVA/ANCOVA model||Week 3|||0.06|-0.22|0.240
71923822|NCT00665366|143368183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.843|TWO_SIDED|95.0|-0.15|0.19|||ANOVA/ANCOVA model||Week 6|||0.19|-0.15|0.843
71923823|NCT00665366|143368183|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.117|TWO_SIDED|95.0|-0.04|0.35|||ANOVA/ANCOVA model||Week 9|||0.35|-0.04|0.117
71923824|NCT00665366|143368183|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.17||||0.109|TWO_SIDED|95.0|-0.04|0.38|||ANOVA/ANCOVA model|Week 12||||0.38|-0.04|0.109
71923825|NCT00665366|143368184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.567|TWO_SIDED|95.0|-0.37|0.2|||ANOVA/ANCOVA model|Week 12||||0.20|-0.37|0.567
71923826|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.566|TWO_SIDED|95.0|-1.66|3.03|||ANCOVA||Total score: Week 3|||3.03|-1.66|0.566
71923827|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66||||0.221||95.0|-1.0|4.32|||ANCOVA||Total score: Week 6|||4.32|-1.00|0.221
71923828|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.315|TWO_SIDED|95.0|-1.4|4.35|||ANCOVA||Total score: Week 9|||4.35|-1.40|0.315
71923829|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.88||||0.212|TWO_SIDED|95.0|-1.08|4.84|||ANCOVA||Total score: Week 12|||4.84|-1.08|0.212
71923830|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.49|0.48|||ANCOVA||Autonomy score: Week 3|||0.48|-0.49|0.991
71923831|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.201|TWO_SIDED|95.0|-0.18|0.85|||ANCOVA||Autonomy score: Week 6|||0.85|-0.18|0.201
71923832|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.198|TWO_SIDED|95.0|-0.19|0.93|||ANCOVA||Autonomy score: Week 9|||0.93|-0.19|0.198
71923833|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.178|TWO_SIDED|95.0|-0.18|0.96|||ANCOVA||Autonomy score: Week 12|||0.96|-0.18|0.178
71923834|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.311|TWO_SIDED|95.0|-1.01|0.32|||ANCOVA||Occupational functioning score: Week 3|||0.32|-1.01|0.311
71688862|NCT02171429|142893180|SUPERIORITY||Mean Difference (Net)|-1.0||||0.0116|TWO_SIDED|95.0|-1.7|-0.2||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||-0.2|-1.7|0.0116
71688863|NCT02171429|142893180|SUPERIORITY||Mean Difference (Net)|-0.1||||0.6771|TWO_SIDED|95.0|-0.8|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.8|0.6771
71688864|NCT02171429|142893181|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
71688865|NCT02171429|142893181|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
71688866|NCT02171429|142893182|SUPERIORITY||Difference in Remission Rates|7.9||||0.1382|TWO_SIDED|95.0|-3.19|16.87||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.87|-3.19|0.1382
71688867|NCT02171429|142893182|SUPERIORITY||Difference in Remission Rates|-7.5||||0.1163|TWO_SIDED|95.0|-17.1|2.22||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.22|-17.10|0.1163
71688868|NCT02171429|142893183|SUPERIORITY||Difference in Remission Rates|2.9||||0.4772|TWO_SIDED|95.0|-6.47|10.14||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.14|-6.47|0.4772
71923835|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.671|TWO_SIDED|95.0|-0.94|0.61|||ANCOVA||Occupational functioning score: Week 6|||0.61|-0.94|0.671
71923836|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.968|TWO_SIDED|95.0|-0.83|0.79|||ANCOVA||Occupational functioning score: Week 9|||0.79|-0.83|0.968
71923837|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.546|TWO_SIDED|95.0|-0.56|1.07|||ANCOVA||Occupational functioning score: Week 12|||1.07|-0.56|0.546
71923838|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.284|TWO_SIDED|95.0|-0.28|0.96|||ANCOVA||Cognitive functioning score: Week 3|||0.96|-0.28|0.284
71923839|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.063|TWO_SIDED|95.0|-0.04|1.35|||ANCOVA||Cognitive functioning score: Week 6|||1.35|-0.04|0.063
71923840|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.62||||0.09|TWO_SIDED|95.0|-0.1|1.34|||ANCOVA||Cognitive functioning score: Week 9|||1.34|-0.10|0.090
71923841|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.68||||0.072|TWO_SIDED|95.0|-0.06|1.42|||ANCOVA||Cognitive functioning score: Week 12|||1.42|-0.06|0.072
71923842|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.499|TWO_SIDED|95.0|-0.45|0.93|||ANCOVA||Interpersonal relationships score: Week 3|||0.93|-0.45|0.499
71923843|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.457|TWO_SIDED|95.0|-0.48|1.06|||ANCOVA||Interpersonal relationships score: Week 6|||1.06|-0.48|0.457
71923844|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.525||95.0|-0.56|1.1|||ANCOVA||Interpersonal relationships score: Week 9|||1.10|-0.56|0.525
71923845|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.544|TWO_SIDED|95.0|-0.58|1.09|||ANCOVA||Interpersonal relationships score: Week 12|||1.09|-0.58|0.544
71923846|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.149|TWO_SIDED|95.0|-0.08|0.52|||ANCOVA||Leisure time score: Week 3|||0.52|-0.08|0.149
71923847|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.264|TWO_SIDED|95.0|-0.15|0.54|||ANCOVA||Leisure time score: Week 6|||0.54|-0.15|0.264
71923848|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.988|TWO_SIDED|95.0|-0.35|0.35|||ANCOVA||Leisure time score: Week 9|||0.35|-0.35|0.988
71923849|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08||||0.641|TWO_SIDED|95.0|-0.27|0.44|||ANCOVA||Leisure time score: Week 12|||0.44|-0.27|0.641
71923850|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.068|TWO_SIDED|95.0|-0.02|0.61|||ANCOVA||Financial issues score: Week 3|||0.61|-0.02|0.068
71923851|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.019|TWO_SIDED|95.0|0.07|0.74|||ANCOVA||Financial issues score: Week 6|||0.74|0.07|0.019
71923852|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.136|TWO_SIDED|95.0|-0.08|0.6|||ANCOVA||Financial issues score: Week 9|||0.60|-0.08|0.136
71923853|NCT00665366|143368185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23||||0.18||95.0|-0.11|0.57|||ANCOVA||Financial issues score: Week 12|||0.57|-0.11|0.18
71923854|NCT00665366|143368186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.13||||0.466|TWO_SIDED|95.0|0.81|1.59|||Ration of response||Week 3|||1.59|0.81|0.466
71923855|NCT00665366|143368186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.54|TWO_SIDED|95.0|0.86|1.32|||Risk ratio||Week 6|||1.32|0.86|0.540
71923856|NCT00665366|143368186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.06|TWO_SIDED|95.0|0.99|1.38|||Risk ratio||Week 9|||1.38|0.99|0.060
71923857|NCT00665366|143368186|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.289|TWO_SIDED|95.0|0.94|1.23|||Risk ratio|||||1.23|0.94|0.289
71923858|NCT00665366|143368187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.909|TWO_SIDED|95.0|0.75|1.39|||Risk ratio (RR)||Week 3|||1.39|0.75|0.909
71923859|NCT00665366|143368187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.06||||0.573|TWO_SIDED|95.0|0.86|1.3|||RR||Week 6|||1.30|0.86|0.573
71923860|NCT00665366|143368187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.16||||0.08|TWO_SIDED|95.0|0.98|1.36|||RR||Week 9|||1.36|0.98|0.080
71923861|NCT00665366|143368187|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.211|TWO_SIDED|95.0|0.95|1.27|||RR||Week 12|||1.27|0.95|0.211
71923862|NCT00665366|143368188|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|||||TWO_SIDED|95.0|0.07|1.29|||ANOVA/ANCOVA model||Week 6|||1.29|0.07|
71923863|NCT00665366|143368188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.031|TWO_SIDED|95.0|0.08|1.58|||ANOVA/ANCOVA model||Week 12|||1.58|0.08|0.031
71923864|NCT00665366|143368188|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.61||||0.104|TWO_SIDED|95.0|-0.13|1.34|||ANOVA/ANCOVA model||Week 12 (LOCF)|||1.34|-0.13|0.104
71923865|NCT00665366|143368189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06|||||TWO_SIDED|95.0|-0.21|0.32|||ANCOVA||Week 3|||0.32|-0.21|
71923866|NCT00665366|143368189|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24|||||TWO_SIDED|95.0|-0.05|0.53|||ANCOVA||Week 6|||0.53|-0.05|
71923867|NCT00665366|143368189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.197|TWO_SIDED|95.0|-0.11|0.54|||ANCOVA||Week 12|||0.54|-0.11|0.197
71923868|NCT00665366|143368189|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.111|TWO_SIDED|95.0|-0.07|0.63|||ANCOVA||Week 12 (LOCF)|||0.63|-0.07|0.111
71923869|NCT00665366|143368190|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.983|TWO_SIDED|95.0|-0.63|0.64|||ANOVA/ANCOVA model||Week 12 LOCF|||0.64|-0.63|0.983
71923870|NCT00665366|143368191|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.45|||||TWO_SIDED|95.0|0.57|3.71|||Risk Ratio|Weight gain||||3.71|0.57|
71923871|NCT00665366|143368192|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.0||||0.582||95.0|||||ANCOVA|||||||0.582
71923872|NCT05111548|143368193|SUPERIORITY|||||||0.923|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.923
71923873|NCT05111548|143368194|SUPERIORITY|||||||0.11|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.110
71923874|NCT05111548|143368195|SUPERIORITY|||||||0.818|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.818
71923875|NCT05111548|143368196|SUPERIORITY|||||||0.13|||||||ANOVA|||Mixed ANOVA (within-subjects factor=time; between-subjects factor=group)||||0.130
71923876|NCT03330275|143368197|NON_INFERIORITY|A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.|Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.0574|||TWO_SIDED|95.0|-0.045|0.183|||Linear Mixed Model|Kenward and Roger Method was used for denominator degrees of freedom|Mean difference was calculated as Test - Control 1|It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.||0.183|-0.045|
71923877|NCT03330275|143368198|NON_INFERIORITY|A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.|Mean Difference (Final Values)|-0.028|STANDARD_ERROR_OF_MEAN|0.0076|||TWO_SIDED|95.0|-0.043|-0.012|||Linear Mixed Model|Kenward and Roger Method was used for the degrees of freedom.|Mean difference was calculated as Test - Control 1|||-0.012|-0.043|
71761096|NCT04672655|143023804|OTHER|||||||0.4811||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.4811
71923878|NCT03330275|143368199|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|3.162|||||TWO_SIDED|95.0|0.442|22.604|||Generalized Estimating Equation||Odds ratio was calculated as Test over Control 1|||22.604|0.442|
71923879|NCT03330275|143368200|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.98|||||TWO_SIDED|95.0|0.82|1.16|||Generalized Linear Mixed Model||Odds ratio was calculated as Test over Control1|||1.16|0.82|
71923880|NCT03330275|143368201|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|5.29|||TWO_SIDED|95.0|7.1|28.5|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test - Control 1|||28.5|7.1|
71923881|NCT03330275|143368202|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.33|1.74|||Generalized Linear Mixed Model||Odds Ratio was calculated as Test over Control 1|||1.74|0.33|
71923882|NCT03330275|143368203|EQUIVALENCE|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|7.93|||TWO_SIDED|95.0|-11.4|20.7|||Linear Mixed Model|Kenward and Roger Method was used for denominator Degrees of Freedom.|Mean difference was calculated as Test - Control 1|||20.7|-11.4|
71923883|NCT04516291|143368204|OTHER||Least Square (LS) Mean difference|-22.4|STANDARD_ERROR_OF_MEAN|4.93|<|0.001|TWO_SIDED|95.0|-32.1|-12.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.7|-32.1|<0.001
71923884|NCT04516291|143368204|OTHER||LS Mean difference|-22.0|STANDARD_ERROR_OF_MEAN|4.88|<|0.001|TWO_SIDED|95.0|-31.7|-12.4|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-12.4|-31.7|<0.001
71923885|NCT04516291|143368204|OTHER||LS Mean difference|-24.1|STANDARD_ERROR_OF_MEAN|5.05|<|0.001|TWO_SIDED|95.0|-34.1|-14.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-14.2|-34.1|<0.001
71923886|NCT04516291|143368204|OTHER||LS Mean difference|-27.7|STANDARD_ERROR_OF_MEAN|4.09|<|0.001|TWO_SIDED|95.0|-35.7|-19.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-19.6|-35.7|<0.001
71923887|NCT04516291|143368204|OTHER||LS Mean difference|-26.6|STANDARD_ERROR_OF_MEAN|3.98|<|0.001|TWO_SIDED|95.0|-34.5|-18.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-18.8|-34.5|<0.001
71923888|NCT04516291|143368204|OTHER||LS Mean difference|-24.7|STANDARD_ERROR_OF_MEAN|3.96|<|0.001|TWO_SIDED|95.0|-32.5|-16.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-16.9|-32.5|<0.001
71923889|NCT04516291|143368204|OTHER||LS Mean difference|-26.5|STANDARD_ERROR_OF_MEAN|4.51|<|0.001|TWO_SIDED|95.0|-35.4|-17.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-17.6|-35.4|<0.001
71923890|NCT04516291|143368206|OTHER||LS Mean difference|-44.0|STANDARD_ERROR_OF_MEAN|6.66|<|0.001|TWO_SIDED|95.0|-57.1|-30.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.8|-57.1|<0.001
71923891|NCT04516291|143368206|OTHER||LS Mean difference|-43.8|STANDARD_ERROR_OF_MEAN|6.64|<|0.001|TWO_SIDED|95.0|-56.9|-30.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-30.7|-56.9|<0.001
71923892|NCT04516291|143368206|OTHER||LS Mean difference|-41.3|STANDARD_ERROR_OF_MEAN|6.85|<|0.001|TWO_SIDED|95.0|-54.8|-27.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-27.8|-54.8|<0.001
71923893|NCT04516291|143368206|OTHER||LS Mean difference|-50.5|STANDARD_ERROR_OF_MEAN|5.54|<|0.001|TWO_SIDED|95.0|-61.4|-39.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-39.6|-61.4|<0.001
71923894|NCT04516291|143368206|OTHER||LS Mean difference|-45.9|STANDARD_ERROR_OF_MEAN|5.38|<|0.001|TWO_SIDED|95.0|-56.5|-35.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-35.2|-56.5|<0.001
71923895|NCT04516291|143368206|OTHER||LS Mean difference|-50.7|STANDARD_ERROR_OF_MEAN|5.35|<|0.001|TWO_SIDED|95.0|-61.2|-40.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-40.1|-61.2|<0.001
71923896|NCT04516291|143368206|OTHER||LS Mean difference|-56.8|STANDARD_ERROR_OF_MEAN|6.14|<|0.001|TWO_SIDED|95.0|-68.9|-44.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||TG||-44.7|-68.9|<0.001
71923897|NCT04516291|143368206|OTHER||LS Mean difference|-15.1|STANDARD_ERROR_OF_MEAN|4.36|<|0.001|TWO_SIDED|95.0|-23.7|-6.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-6.5|-23.7|<0.001
71923898|NCT04516291|143368206|OTHER||LS Mean difference|-10.6|STANDARD_ERROR_OF_MEAN|4.34||0.015|TWO_SIDED|95.0|-19.2|-2.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.1|-19.2|0.015
71923899|NCT04516291|143368206|OTHER||LS Mean difference|-11.5|STANDARD_ERROR_OF_MEAN|4.49||0.011|TWO_SIDED|95.0|-20.3|-2.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-2.7|-20.3|0.011
71923900|NCT04516291|143368206|OTHER||LS Mean difference|-12.5|STANDARD_ERROR_OF_MEAN|3.64|<|0.001|TWO_SIDED|95.0|-19.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.3|-19.7|<0.001
71923901|NCT04516291|143368206|OTHER||LS Mean difference|-12.6|STANDARD_ERROR_OF_MEAN|3.54|<|0.001|TWO_SIDED|95.0|-19.5|-5.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-5.6|-19.5|<0.001
71923902|NCT04516291|143368206|OTHER||LS Mean difference|-6.0|STANDARD_ERROR_OF_MEAN|3.56||0.095|TWO_SIDED|95.0|-13.0|1.0|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||1.0|-13.0|0.095
71923903|NCT04516291|143368206|OTHER||LS Mean difference|-8.5|STANDARD_ERROR_OF_MEAN|4.01||0.036|TWO_SIDED|95.0|-16.4|-0.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||ApoB||-0.6|-16.4|0.036
71923904|NCT04516291|143368206|OTHER||LS Mean difference|-10.0|STANDARD_ERROR_OF_MEAN|6.55||0.129|TWO_SIDED|95.0|-22.9|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-22.9|0.129
71923905|NCT04516291|143368206|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|6.65||0.238|TWO_SIDED|95.0|-21.0|5.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||5.2|-21.0|0.238
71923906|NCT04516291|143368206|OTHER||LS Mean difference|-11.4|STANDARD_ERROR_OF_MEAN|6.73||0.09|TWO_SIDED|95.0|-24.7|1.8|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||1.8|-24.7|0.090
71923907|NCT04516291|143368206|OTHER||LS Mean difference|-16.0|STANDARD_ERROR_OF_MEAN|5.44||0.004|TWO_SIDED|95.0|-26.7|-5.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-5.3|-26.7|0.004
71923908|NCT04516291|143368206|OTHER||LS Mean difference|-14.5|STANDARD_ERROR_OF_MEAN|5.38||0.008|TWO_SIDED|95.0|-25.1|-3.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||-3.9|-25.1|0.008
71923909|NCT04516291|143368206|OTHER||LS Mean difference|-7.9|STANDARD_ERROR_OF_MEAN|5.28||0.136|TWO_SIDED|95.0|-18.3|2.5|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.5|-18.3|0.136
71923910|NCT04516291|143368206|OTHER||LS Mean difference|-9.0|STANDARD_ERROR_OF_MEAN|6.01||0.138|TWO_SIDED|95.0|-20.8|2.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||LDL-C||2.9|-20.8|0.138
71923911|NCT04516291|143368208|OTHER||LS Mean difference|-69.9|STANDARD_ERROR_OF_MEAN|5.97|<|0.001|TWO_SIDED|95.0|-81.6|-58.1|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-58.1|-81.6|<0.001
71923912|NCT04516291|143368208|OTHER||LS Mean difference|-79.6|STANDARD_ERROR_OF_MEAN|6.03|<|0.001|TWO_SIDED|95.0|-91.5|-67.7|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-67.7|-91.5|<0.001
71923913|NCT04516291|143368208|OTHER||LS Mean difference|-77.1|STANDARD_ERROR_OF_MEAN|6.22|<|0.001|TWO_SIDED|95.0|-89.4|-64.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-64.9|-89.4|<0.001
71923914|NCT04516291|143368208|OTHER||LS Mean difference|-86.3|STANDARD_ERROR_OF_MEAN|5.04|<|0.001|TWO_SIDED|95.0|-96.2|-76.3|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-76.3|-96.2|<0.001
71923915|NCT04516291|143368208|OTHER||LS Mean difference|-80.4|STANDARD_ERROR_OF_MEAN|4.82|<|0.001|TWO_SIDED|95.0|-89.9|-70.9|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-70.9|-89.9|<0.001
71923916|NCT04516291|143368208|OTHER||LS Mean difference|-92.2|STANDARD_ERROR_OF_MEAN|4.92|<|0.001|TWO_SIDED|95.0|-101.9|-82.6|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-82.6|-101.9|<0.001
71923917|NCT04516291|143368208|OTHER||LS Mean difference|-95.2|STANDARD_ERROR_OF_MEAN|5.59|<|0.001|TWO_SIDED|95.0|-106.2|-84.2|||Mixed Models Analysis|MMRM with baseline value, treatment, visit, interaction term of treatment by visit as fixed effects and unstructured covariance structure was used.||||-84.2|-106.2|<0.001
71923918|NCT00649220|143368209|SUPERIORITY_OR_OTHER|||||||0.22626||95.0|||||t-test, 2 sided|||Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.22626
71923919|NCT00649220|143368209|SUPERIORITY_OR_OTHER|||||||0.34192||95.0|||||Wilcoxon signed rank test|||Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline||||0.34192
71923920|NCT00351611|143368240|NON_INFERIORITY|Non-inferiority was demonstrated if the upper CI bound was less than 0.10 (10%).|Difference in percentage of participants|-1.7094|||||TWO_SIDED|95.0|-9.1751|5.9784||||||A 2-sided 95 percent (%) confidence interval (CI) on the difference in percentage of participants, between pregabalin and placebo was constructed using unconditional exact methods.||5.9784|-9.1751|
71923921|NCT00351611|143368241|NON_INFERIORITY|Non-inferiority with respect to mean deviation was demonstrated if the lower bound of the CI is greater than -2.0 decibels.|Difference in LS mean|-0.125||||0.4414|TWO_SIDED|95.0|-0.443|0.194|||ANCOVA|||Analysis of covariance (ANCOVA) with treatment and center in the model and the baseline mean deviation as the covariate was used to construct a 2-sided 95% CI on the difference in least squares (LS) mean between pregabalin and placebo.||0.194|-0.443|0.4414
71923922|NCT00351611|143368242|OTHER||Difference in LS mean|-0.9||||0.1346|TWO_SIDED|95.0|-2.083|0.283|||ANCOVA|||ANCOVA with treatment and center in the model and the baseline visual acuity as the covariate was used to construct a 2-sided 95% confidence interval on the difference in LS mean between pregabalin and placebo.||0.283|-2.083|0.1346
71923923|NCT00368069|143368248|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.155||||0.038||95.0|0.009|0.301|||ANCOVA|Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.||||0.301|0.009|0.038
71923924|NCT00368069|143368248|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.4||||||95.0|0.9|26.0|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over PBO is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.0|0.9|
71923925|NCT00368069|143368250|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.158||||0.034||95.0|0.012|0.305|||ANCOVA|ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.||||0.305|0.012|0.034
71923926|NCT00368069|143368250|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|14.7||||||95.0|1.2|26.3|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||26.3|1.2|
71923927|NCT00368069|143368251|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.84||||0.07||95.0|0.95|3.55|||Regression, Logistic|Logistic regression analysis including Treatment as a factor.|Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.|||3.55|0.95|0.070
71923928|NCT00368069|143368252|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Mantel Haenszel|Subjects with missing data during the Treatment period were considered in the category \<-25%.||||||0.033
71923929|NCT00368069|143368253|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.205||||0.003||95.0|0.07|0.341|||ANCOVA|ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate||||0.341|0.070|0.003
71923930|NCT00368069|143368253|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over Placebo|18.6||||||95.0|6.7|28.9|||Transf. of ANCOVA results on log data|Percent Reduction of Keppra over Placebo is calculated based on the ANCOVA on log data as 100\*(1-exp(LSmeans Keppra -LSMeans Placebo))||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data||28.9|6.7|
71923931|NCT04680273|143368262|OTHER||Geometric mean ratio|0.573|STANDARD_DEVIATION|1.11|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 10.4%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of GDC-9545 in plasma samples compared with the AUC(0-72) of total radioactivity in plasma samples.||||
71923932|NCT04680273|143368262|OTHER||Geometric mean ratio|0.752|STANDARD_DEVIATION|1.036|||||||||||The geometric coefficient of variation (%) for the AUC(0-72) geometric mean ratio was 3.5%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-72) of total radioactivity (TR) in whole blood samples compared with the AUC(0-72) of TR in plasma samples.||||
71923933|NCT04680273|143368263|OTHER||Geometric mean ratio|0.625|STANDARD_DEVIATION|1.134|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 12.7%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of GDC-9545 in plasma samples compared with the AUC(0-t) of total radioactivity in plasma samples.||||
71923934|NCT04680273|143368263|OTHER||Geometric mean ratio|0.79|STANDARD_DEVIATION|1.171|||||||||||The geometric coefficient of variation (%) for the AUC(0-t) geometric mean ratio was 15.9%. The standard deviation (SD) reported is a geometric SD.|The geometric mean ratio was calculated for the AUC(0-t) of total radioactivity (TR) in whole blood samples compared with the AUC(0-t) of TR in plasma samples.||||
71923935|NCT01430559|143368307|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from analysis of covariance (ANCOVA, repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||||-0.43|-1.20|<0.0001
71923936|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.14||0.0103|TWO_SIDED|95.0|-0.65|-0.09||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 2)||-0.09|-0.65|0.0103
71923937|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0295|TWO_SIDED|95.0|-0.67|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 4)||-0.04|-0.67|0.0295
71923938|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.18||0.0041|TWO_SIDED|95.0|-0.87|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 8)||-0.17|-0.87|0.0041
71923939|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.2|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Pain subscale (Week 12)||-0.43|-1.20|<0.0001
71923940|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.16||0.0369|TWO_SIDED|95.0|-0.64|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 2)||-0.02|-0.64|0.0369
71923941|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.2642|TWO_SIDED|95.0|-0.54|0.15||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 4)||0.15|-0.54|0.2642
71923942|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.19||0.014|TWO_SIDED|95.0|-0.84|-0.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 8)||-0.10|-0.84|0.0140
71923943|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.2||0.0009|TWO_SIDED|95.0|-1.06|-0.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Stiffness subscale (Week 12)||-0.28|-1.06|0.0009
71923944|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.14||0.0017|TWO_SIDED|95.0|-0.72|-0.17||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 2)||-0.17|-0.72|0.0017
71923945|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.16||0.0328|TWO_SIDED|95.0|-0.66|-0.03||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 4)||-0.03|-0.66|0.0328
71923946|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.18||0.0043|TWO_SIDED|95.0|-0.86|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 8)||-0.16|-0.86|0.0043
71923947|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.19|-0.43||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical function subscale (Week 12)||-0.43|-1.19|<0.0001
71923948|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.13||0.0051|TWO_SIDED|95.0|-0.65|-0.12||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 2)||-0.12|-0.65|0.0051
71923949|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0593|TWO_SIDED|95.0|-0.61|0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 4)||0.01|-0.61|0.0593
71923950|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0046|TWO_SIDED|95.0|-0.84|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 8)||-0.16|-0.84|0.0046
71761097|NCT04672655|143023805|OTHER|||||||0.754||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.754
71923951|NCT01430559|143368308|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.19|<|0.0001|TWO_SIDED|95.0|-1.14|-0.39||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Average score (Week 12)||-0.39|-1.14|<0.0001
71923952|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.16||0.0002|TWO_SIDED|95.0|-0.94|-0.3||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 2)||-0.30|-0.94|0.0002
71923953|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.18||0.0015|TWO_SIDED|95.0|-0.92|-0.22||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 4)||-0.22|-0.92|0.0015
71923954|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.19||0.0003|TWO_SIDED|95.0|-1.08|-0.32||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 8)||-0.32|-1.08|0.0003
71923955|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.93|STANDARD_ERROR_OF_MEAN|0.21|<|0.0001|TWO_SIDED|95.0|-1.34|-0.51||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Walking on flat surface (Week 12)||-0.51|-1.34|<0.0001
71923956|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.17||0.0363|TWO_SIDED|95.0|-0.67|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 2)||-0.02|-0.67|0.0363
71923957|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.18||0.0311|TWO_SIDED|95.0|-0.75|-0.04||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 4)||-0.04|-0.75|0.0311
71923958|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.0057|TWO_SIDED|95.0|-0.94|-0.16||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 8)||-0.16|-0.94|0.0057
71923959|NCT01430559|143368309|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-1.08|STANDARD_ERROR_OF_MEAN|0.22|<|0.0001|TWO_SIDED|95.0|-1.52|-0.64||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Going up or down stairs (Week 12)||-0.64|-1.52|<0.0001
71923960|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.42||||0.2373|TWO_SIDED|95.0|0.79|2.55||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 2)||2.55|0.79|0.2373
71923961|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.38||||0.2069|TWO_SIDED|95.0|0.84|2.26||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 4)||2.26|0.84|0.2069
71923962|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.56||||0.068|TWO_SIDED|95.0|0.97|2.53||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 8)||2.53|0.97|0.0680
71923963|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.41||||0.0005|TWO_SIDED|95.0|1.47|3.94||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=30% reduction (Week 12)||3.94|1.47|0.0005
71923964|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.94||||0.1736|TWO_SIDED|95.0|0.75|5.01||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 2)||5.01|0.75|0.1736
71923965|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1496|TWO_SIDED|95.0|0.82|3.59||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 4)||3.59|0.82|0.1496
71923966|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.12||||0.0171|TWO_SIDED|95.0|1.14|3.93||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 8)||3.93|1.14|0.0171
71923967|NCT01430559|143368311|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.77||||0.0004|TWO_SIDED|95.0|1.57|4.89||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||\>=50% reduction (Week 12)||4.89|1.57|0.0004
71923968|NCT01430559|143368312|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.06||0.0027|TWO_SIDED|95.0|-0.31|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.07|-0.31|0.0027
71923969|NCT01430559|143368312|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.0308|TWO_SIDED|95.0|-0.3|-0.01||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||-0.01|-0.30|0.0308
71923970|NCT01430559|143368312|SUPERIORITY_OR_OTHER_LEGACY|P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|Least Squares Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.06||0.006|TWO_SIDED|95.0|-0.31|-0.05|||ANCOVA|||Week 8||-0.05|-0.31|0.0060
71923971|NCT01430559|143368312|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.07||0.0076|TWO_SIDED|95.0|-0.34|-0.05||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.05|-0.34|0.0076
71923972|NCT01430559|143368313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.13||||0.2843|TWO_SIDED|95.0|0.53|8.5||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 2||8.50|0.53|0.2843
71688869|NCT02171429|142893183|SUPERIORITY||Difference in Remission Rates|-5.2||||0.1801|TWO_SIDED|95.0|-12.95|2.63||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||2.63|-12.95|0.1801
71688870|NCT02171429|142893184|SUPERIORITY||Difference in Adjusted Means|4.0||||0.4833|TWO_SIDED|95.0|-7.2|15.2||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||15.2|-7.2|0.4833
71688871|NCT02171429|142893184|SUPERIORITY||Difference in Adjusted Means|0.0||||0.9931|TWO_SIDED|95.0|-9.2|9.1||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.1|-9.2|0.9931
71688872|NCT00909220|142893192|SUPERIORITY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.06||0.05|TWO_SIDED|95.0|0.27|0.49|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).||0.49|0.27|0.05
71688873|NCT00909220|142893193|SUPERIORITY|ANCOVA|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|95.0|0.31|0.59|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).||0.59|0.31|<0.05
71923973|NCT01430559|143368313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.05||||0.105|TWO_SIDED|95.0|0.86|4.87||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 4||4.87|0.86|0.1050
71923974|NCT01430559|143368313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.16||||0.7861|TWO_SIDED|95.0|0.4|3.32||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 8||3.32|0.40|0.7861
71923975|NCT01430559|143368313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.71||||0.1873|TWO_SIDED|95.0|0.77|3.78||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Week 12||3.78|0.77|0.1873
71923976|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|1.38|STANDARD_ERROR_OF_MEAN|1.55||0.3738|TWO_SIDED|95.0|-1.67|4.42||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||General health||4.42|-1.67|0.3738
71688874|NCT00909220|142893194|OTHER|Multiple regression analyses|beta|0.43|STANDARD_ERROR_OF_MEAN|6.75||0.02|TWO_SIDED|||||p \<0.05 a priori threshold for statistical significance.|Regression, Linear|||||||.02
71761098|NCT04672655|143023806|OTHER|||||||0.0406||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.0406
71923977|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.94|STANDARD_ERROR_OF_MEAN|1.96||0.0028|TWO_SIDED|95.0|2.07|9.8||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical functioning||9.80|2.07|0.0028
71923978|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|8.16|STANDARD_ERROR_OF_MEAN|2.14||0.0002|TWO_SIDED|95.0|3.95|12.38||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role physical||12.38|3.95|0.0002
71923979|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|7.36|STANDARD_ERROR_OF_MEAN|1.66|<|0.0001|TWO_SIDED|95.0|4.1|10.63||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Bodily pain||10.63|4.10|<0.0001
71923980|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.05|STANDARD_ERROR_OF_MEAN|1.64||0.2124|TWO_SIDED|95.0|-1.18|5.27||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Vitality||5.27|-1.18|0.2124
71923981|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.96|STANDARD_ERROR_OF_MEAN|2.1||0.005|TWO_SIDED|95.0|1.82|10.1||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Social functioning||10.10|1.82|0.0050
71923982|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.87|STANDARD_ERROR_OF_MEAN|2.24||0.0093|TWO_SIDED|95.0|1.46|10.28||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Role emotional||10.28|1.46|0.0093
71923983|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.57|STANDARD_ERROR_OF_MEAN|1.64||0.7274|TWO_SIDED|95.0|-2.66|3.81||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental health||3.81|-2.66|0.7274
71923984|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.94|STANDARD_ERROR_OF_MEAN|0.88||0.2819|TWO_SIDED|95.0|-0.78|2.67||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Mental component aggregate||2.67|-0.78|0.2819
71923985|NCT01430559|143368314|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|2.57|STANDARD_ERROR_OF_MEAN|0.66||0.0001|TWO_SIDED|95.0|1.27|3.86||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Physical component aggregate||3.86|1.27|0.0001
71923986|NCT01430559|143368315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.6||||0.0014|TWO_SIDED|95.0|1.45|4.66||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Mobility||4.66|1.45|0.0014
71923987|NCT01430559|143368315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.51||||0.108|TWO_SIDED|95.0|0.91|2.48||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Self-care||2.48|0.91|0.1080
71923988|NCT01430559|143368315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.06||||0.0119|TWO_SIDED|95.0|1.17|3.62||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Usual activities||3.62|1.17|0.0119
71923989|NCT01430559|143368315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.62||||0.0887|TWO_SIDED|95.0|0.93|2.83||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Pain/discomfort||2.83|0.93|0.0887
71923990|NCT01430559|143368315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.37||||0.2466|TWO_SIDED|95.0|0.8|2.33||P-value and 95% confidence interval for odds ratio were calculated from logistic regression model (including baseline value and treatment group as factors) for binary data for comparison of meloxicam group versus placebo.|Regression, Logistic|||Anxiety/depression||2.33|0.80|0.2466
71923991|NCT01430559|143368316|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0367|TWO_SIDED|95.0|-0.58|-0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 2||-0.02|-0.58|0.0367
71923992|NCT01430559|143368316|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.17||0.0652|TWO_SIDED|95.0|-0.65|0.02||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 4||0.02|-0.65|0.0652
71923993|NCT01430559|143368316|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.19||0.02|TWO_SIDED|95.0|-0.81|-0.07||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 8||-0.07|-0.81|0.0200
71688875|NCT00909220|142893195|OTHER|Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.|Slope|2.58|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED|95.0|1.22|2.77||The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.|Regression, Logistic|df = 31||A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.||2.77|1.22|<0.05
71923994|NCT01430559|143368316|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.0016|TWO_SIDED|95.0|-1.02|-0.24||P-value and 95% confidence interval for least squares mean difference were calculated from ANCOVA (repeated measures) model with baseline value and treatment group as fixed effects, and study site as a random effect.|ANCOVA|||Week 12||-0.24|-1.02|0.0016
71923995|NCT01177943|143368317|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of geometric means.|Ratio of Geometric LS Mean values|0.945|||||TWO_SIDED|90.0|0.858|1.04|||ANOVA|||||1.04|0.858|
71923996|NCT01177943|143368318|NON_INFERIORITY_OR_EQUIVALENCE|80-125% was used for bioequivalence (BE) criteria in terms of the ratio of geometric means.|Ratio of AUC(0-tlast) values|1.03|||||TWO_SIDED|90.0|1.0|1.07|||ANOVA|||||1.07|1.00|
71688876|NCT01763203|142893225|SUPERIORITY|||||||0.73|||||||Mixed Models Analysis|||||||0.73
71688877|NCT01763203|142893226|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
71688878|NCT01763203|142893228|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|||||||0.002
71923997|NCT00808665|143368319|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71923998|NCT03319160|143368320|OTHER||Incidence per 100 patient-years|7.5|STANDARD_DEVIATION|2.74|||TWO_SIDED|95.0|6.3|8.7|||||"Poisson distribution assumed due to the infrequent nature of the events. Number of appropriate shock events: 19 (17 subjects had one appropriate shock event, one subject had two appropriate shock events).~Length of exposure: 253 patient-years."|||8.7|6.3|
71923999|NCT03319160|143368322|OTHER||Incidence per 100 patient-years|3.2|STANDARD_DEVIATION|1.78|||TWO_SIDED|95.0|1.9|4.4|||||||Poisson distribution assumed due to the infrequent nature of the events. Number of inappropriately shocked events: 8. Length of exposure: 253 patient-years.|4.4|1.9|
71688879|NCT01763203|142893229|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71688880|NCT01763203|142893230|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.10
71688881|NCT01763203|142893231|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
71924000|NCT03301272|143368339|OTHER||Difference in differences|0.0||||0.5|TWO_SIDED|||||The threshold for statistical significance is 0.05|Regression, Linear|||||||0.5
71924001|NCT02347345|143368344|OTHER|Descriptive pilot study. Not relevant.||||||0.07|||||||Kruskal-Wallis|||||||0.07
71924002|NCT03457701|143368349|SUPERIORITY||Adjusted mean difference.|0.02||||0.9971|TWO_SIDED|95.0|-10.13|10.16|||Mixed Models Analysis||Analysis was based on a mixed effects model fitted with fixed effect terms for treatment, period, and iron isotope type and a random participant effect.|The null hypotheses is defined as the difference in fractional iron absorption between treatment arms (Daprodustat - rhEPO \[i.e., epoetin alfa or darbepoetin alfa\]) is equal to zero.||10.16|-10.13|0.9971
71924003|NCT01288911|143368409|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.34|0.57|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.||0.57|0.34|<0.0001
71924004|NCT01288911|143368410|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.42|||<|0.0001|TWO_SIDED|95.0|0.33|0.55|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.||0.55|0.33|<0.0001
71924005|NCT01288911|143368411|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
71924006|NCT01288911|143368412|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Wilcoxon rank sum test|||Best PSA Response Enzalutamide Vs. Bicalutamide.||||<0.0001
71924007|NCT01288911|143368413|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.2|0.39|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA progression Enzalutamide Vs. Bicalutamide.||0.39|0.20|<0.0001
71924008|NCT01288911|143368414|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.07|||<|0.0001|TWO_SIDED|95.0|3.18|8.09|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA Enzalutamide Vs. Bicalutamide.||8.09|3.18|<0.0001
71924009|NCT01288911|143368415|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|5.55|||<|0.0001|TWO_SIDED|95.0|3.96|7.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 30% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||7.79|3.96|<0.0001
71924010|NCT01288911|143368416|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.01|||<|0.0001|TWO_SIDED|95.0|4.83|10.16|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 50% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||10.16|4.83|<0.0001
71688882|NCT01763203|142893232|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|||||||0.011
71688883|NCT01763203|142893233|SUPERIORITY|||||||0.47|||||||Mixed Models Analysis|||||||0.47
71688884|NCT01763203|142893234|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||||||0.58
71688885|NCT01763203|142893235|SUPERIORITY|||||||0.74|||||||Mixed Models Analysis|||||||0.74
71924011|NCT01288911|143368417|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|13.91|||<|0.0001|TWO_SIDED|95.0|7.23|26.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 90% PSA decline from baseline Enzalutamide Vs. Bicalutamide.||26.79|7.23|<0.0001
71924012|NCT01288911|143368418|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.51||||0.0002|TWO_SIDED|95.0|0.36|0.74|||Log Rank||Estimated by use of Cox proportional hazards model.|Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.||0.74|0.36|0.0002
71924013|NCT02543918|143368431|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|1.4|||||TWO_SIDED|90.0|-16.6|19.2||||||Tetanus vaccine responders||19.2|-16.6|
71924014|NCT02543918|143368431|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|-0.8|||||TWO_SIDED|90.0|-12.9|11.0||||||Pneumococcal vaccine responders||11.0|-12.9|
71924015|NCT00387621|143368512|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|With Bonferroni correction for multiple comparisons||||||<0.05
71924016|NCT00387621|143368513|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||rank-sum test|Rank-sum test was used due to non-normality of data with Bonferroni correction for multiple comparisons||||||<0.05
71924017|NCT02451137|143368522|SUPERIORITY||Odds Ratio (OR)|1.19||||0.0308|TWO_SIDED|95.4|1.01|1.39||Threshold for significance at 0.046 level.|Regression, Logistic|||A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (\<8%,\<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).||1.39|1.01|0.0308
71924018|NCT03747497|143368535|OTHER||Median Difference (Net)|-0.6|||||TWO_SIDED|95.0|-14.0|2.8||||||||2.8|-14.0|
71924019|NCT02545504|143368587|SUPERIORITY||Cox Proportional Hazard|0.93||||0.5625|TWO_SIDED|95.0|0.74|1.18||The significance level at final analysis is 0.046 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by Eastern Cooperative Oncology Group (ECOG) status, geographic region and primary tumor site.|Hazard ratio (HR) was stratified by ECOG status, geographic region and primary tumor site with treatment arm as the only covariate.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.||1.18|0.74|0.5625
71924020|NCT02545504|143368588|SUPERIORITY||Cox Proportional Hazard|0.84||||0.1031|TWO_SIDED|95.0|0.67|1.04||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by ECOG status,geographic region and primary tumor site.|HR was stratified by ECOG status,geographic region;primary tumor site with treatment arm as a covariate.Stratum with \<6 participants or no informative event by combined treatment arms was pooled with smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.||1.04|0.67|0.1031
71924021|NCT02545504|143368589|SUPERIORITY||Odds Ratio (OR)|1.47||||0.0493|TWO_SIDED|95.0|1.0|2.15||The significance level at final analysis was 0.032 (two-sided). Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Cochran-Mantel-Haenszel|p-value was stratified by ECOG status, geographic region and primary tumor site.|OR was stratified by ECOG status, geographic region and primary tumor site. Stratum with \< 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.||2.15|1.00|0.0493
71924022|NCT02545504|143368589|SUPERIORITY||ORR Difference|9.4|||||TWO_SIDED|95.0|0.1|18.8|||||The 2-sided 95% confidence interval (CI) of difference for ORR between the treatment and placebo is calculated based on stratum-adjusted Cochran-Mantel-Haenszel proportion.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.||18.8|0.1|
71924023|NCT00329433|143368616|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of \<0.05.||||<0.05
71924024|NCT00329433|143368617|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71924025|NCT00329433|143368618|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71924026|NCT01189201|143368619|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.9|STANDARD_DEVIATION|7.2|||TWO_SIDED|90.0|102.07|107.8|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability||107.80|102.07|
71924027|NCT01189201|143368620|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.91|STANDARD_DEVIATION|12.8|||TWO_SIDED|90.0|99.97|110.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||110.09|99.97|
71688886|NCT01763203|142893236|SUPERIORITY|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||||||0.0021
71688887|NCT01763203|142893237|SUPERIORITY|||||||0.07|||||||Mixed Models Analysis|||||||0.07
71688888|NCT01763203|142893238|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
71688889|NCT01763203|142893239|SUPERIORITY|||||||0.77|||||||Chi-squared|||||||0.77
71688890|NCT01763203|142893240|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.20
71688891|NCT01763203|142893241|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71688892|NCT01763203|142893242|SUPERIORITY|||||||0.93|||||||t-test, 2 sided|||||||0.93
71924028|NCT01189201|143368621|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|107.68|STANDARD_DEVIATION|15.3|||TWO_SIDED|90.0|101.7|114.02|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||114.02|101.70|
71924029|NCT01189201|143368622|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|109.68|STANDARD_DEVIATION|26.2|||TWO_SIDED|90.0|99.55|120.83|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||120.83|99.55|
71924030|NCT01189201|143368625|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.78|STANDARD_DEVIATION|7.1|||TWO_SIDED|90.0|102.02|107.61|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||107.61|102.02|
71924031|NCT01189201|143368626|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.64|STANDARD_DEVIATION|19.7|||TWO_SIDED|90.0|97.23|112.62|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||112.62|97.23|
71924032|NCT01189201|143368627|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.86|STANDARD_DEVIATION|9.3|||TWO_SIDED|90.0|81.33|90.64|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.64|81.33|
71924033|NCT01189201|143368628|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|61.41|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|54.1|69.71|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||69.71|54.10|
71924034|NCT01189201|143368629|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.32|STANDARD_DEVIATION|9.4|||TWO_SIDED|90.0|80.77|90.14|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||90.14|80.77|
71924035|NCT01189201|143368630|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|93.18|STANDARD_DEVIATION|15.7|||TWO_SIDED|90.0|85.07|102.05|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||102.05|85.07|
71924036|NCT01189201|143368631|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|68.48|STANDARD_DEVIATION|27.2|||TWO_SIDED|90.0|58.59|80.03|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||80.03|58.59|
71924037|NCT01189201|143368632|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|90.95|STANDARD_DEVIATION|13.2|||TWO_SIDED|90.0|84.24|98.19|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||98.19|84.24|
71924038|NCT01189201|143368633|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.64|STANDARD_DEVIATION|9.6|||TWO_SIDED|90.0|91.19|100.3|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.30|91.19|
71924039|NCT01189201|143368634|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|98.04|STANDARD_DEVIATION|13.0|||TWO_SIDED|90.0|91.95|104.53|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||104.53|91.95|
71688893|NCT01763203|142893243|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.80
71688894|NCT01763203|142893244|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.25
71688895|NCT02187861|142893245|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-13.38|21.23||||||||21.23|-13.38|
71688896|NCT02187861|142893246|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-15.89|19.81||||||||19.81|-15.89|
71688897|NCT02187861|142893247|SUPERIORITY_OR_OTHER||Difference in response rates|1.96|||||TWO_SIDED|95.0|-17.07|20.99||||||||20.99|-17.07|
71688898|NCT02187861|142893248|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-27.01|11.32||||||||11.32|-27.01|
71688899|NCT02187861|142893249|SUPERIORITY_OR_OTHER||Difference in response rates|13.73|||||TWO_SIDED|95.0|-4.24|31.69||||||At 6-8 weeks after Cycle 6 Day 1||31.69|-4.24|
71924040|NCT01189201|143368635|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.69|STANDARD_DEVIATION|9.8|||TWO_SIDED|90.0|91.17|100.43|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.43|91.17|
71924041|NCT01189201|143368636|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|92.98|STANDARD_DEVIATION|14.9|||TWO_SIDED|90.0|86.36|100.09|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||100.09|86.36|
71924042|NCT01189201|143368637|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|103.71|STANDARD_DEVIATION|22.4|||TWO_SIDED|90.0|92.93|115.74|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||115.74|92.93|
71688900|NCT02187861|142893249|SUPERIORITY_OR_OTHER||Difference in response rates|3.92|||||TWO_SIDED|95.0|-12.98|20.82||||||At Year 1||20.82|-12.98|
71924043|NCT01189201|143368638|NON_INFERIORITY_OR_EQUIVALENCE|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|96.36|STANDARD_DEVIATION|14.3|||TWO_SIDED|90.0|89.78|103.42|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability||103.42|89.78|
71688901|NCT02187861|142893250|SUPERIORITY_OR_OTHER||Difference in response rates|-15.69|||||TWO_SIDED|95.0|-31.87|0.49||||||At 4-10 weeks after Cycle 6 Day 1||0.49|-31.87|
71688902|NCT02187861|142893250|SUPERIORITY_OR_OTHER||Difference in response rates|-7.84|||||TWO_SIDED|95.0|-22.56|6.87||||||At Year 1||6.87|-22.56|
71688903|NCT02187861|142893256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.27|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.||1.27|0.38|
71688904|NCT02187861|142893256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.43|1.4|||||HR was calculated using Cox regression.|Unstratified Analysis||1.40|0.43|
71688905|NCT02187861|142893258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.||1.24|0.38|
71688906|NCT02187861|142893258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
71688907|NCT02187861|142893260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.||1.24|0.38|
71688908|NCT02187861|142893260|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis||1.36|0.43|
71688909|NCT02187861|142893262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.48|||||TWO_SIDED|95.0|0.04|5.37|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.||5.37|0.04|
71688910|NCT02187861|142893262|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.05|5.63|||||HR was calculated using Cox regression.|Unstratified Analysis||5.63|0.05|
71688911|NCT04957212|142893272|EQUIVALENCE|We used an equivalence margin of 0.2 for the primary endpoint.|Risk Difference (RD)|-0.04||||0.54|TWO_SIDED|95.0|-0.16|0.09|||Chi-squared|||||0.09|-0.16|0.54
71688912|NCT04957212|142893273|OTHER||Risk Difference (RD)|-0.07||||0.26|TWO_SIDED|95.0|-0.21|0.06|||Chi-squared|||||0.06|-0.21|0.26
71688913|NCT04957212|142893274|OTHER|||||||0.99|||||||Fisher Exact|||||||0.99
71688914|NCT04957212|142893275|OTHER|||||||0.56|||||||Chi-squared|||||||0.56
71688915|NCT01768559|142893299|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|Least Square (LS) Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|-0.17|0.064|||ANCOVA||Lixisenatide vs Insulin Glulisine QD|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (\<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).||0.064|-0.17|
71688916|NCT01768559|142893299|NON_INFERIORITY_OR_EQUIVALENCE|Pre-specified non-inferiority margin of 0.4%.|LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|0.059|||TWO_SIDED|95.0|0.095|0.328|||ANCOVA||Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||0.328|0.095|
71688917|NCT01768559|142893300|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.99|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-2.593|-1.396||Threshold for significance at 0.025 level.|ANCOVA|The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.|Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).||-1.396|-2.593|< 0.0001
71688918|NCT00351936|142893346|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
71688919|NCT00351936|142893347|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||ANCOVA|||||||0.003
71688920|NCT00351936|142893348|SUPERIORITY_OR_OTHER|||||||0.747||95.0|||||ANCOVA|||||||0.747
71688921|NCT00351936|142893349|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||ANCOVA|||||||0.208
71688922|NCT00351936|142893350|SUPERIORITY_OR_OTHER|||||||0.665||95.0|||||ANCOVA|||||||0.665
71688923|NCT00351936|142893351|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||ANCOVA|||||||0.999
71924044|NCT04308668|143368646|SUPERIORITY||Mean Difference (Net)|-2.4||||0.35|TWO_SIDED|95.0|-7.0|2.2|||Fisher Exact||Values represent percentages. Experimental treatment arm compared with the placebo control arm.|||2.2|-7.0|0.35
71924045|NCT04308668|143368647|SUPERIORITY||Mean Difference (Net)|-0.27||||0.117|TWO_SIDED|95.0|-0.61|0.27|||Mixed Models Analysis|||||0.27|-0.61|0.117
71924046|NCT01266967|143368655|SUPERIORITY_OR_OTHER||percentage of participants|41.0|||<|0.0001|TWO_SIDED|95.0|29.3|52.6|||Exact Test||The estimated value represents the percentage of participants with OIR.|||52.6|29.3|<0.0001
71924047|NCT01266967|143368655|SUPERIORITY_OR_OTHER||percentage of participants|37.0|||<|0.0001|TWO_SIDED|95.0|25.3|49.8|||Exact Test||The estimated value represents the percentage of participants with OIR.|||49.8|25.3|<0.0001
71924048|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.47|||TWO_SIDED|90.0|-1.99|2.9||||||||2.90|-1.99|
71924049|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.73|2.24||||||||2.24|-2.73|
71924050|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.25|2.79||||||||2.79|-2.25|
71924051|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-1.94|3.09||||||||3.09|-1.94|
71924052|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.62|2.35||||||||2.35|-2.62|
71924053|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-0.88|4.11||||||||4.11|-0.88|
71924054|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.66|||TWO_SIDED|90.0|-1.63|3.85||||||||3.85|-1.63|
71924055|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.79|||TWO_SIDED|90.0|-3.13|2.79||||||||2.79|-3.13|
71924056|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|2.13|||TWO_SIDED|90.0|-2.6|4.47||||||||4.47|-2.60|
71924057|NCT03808298|143368684|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|-2.03|2.98||||||||2.98|-2.03|
71924058|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-0.19|2.64||||||||2.64|-0.19|
71688924|NCT00351936|142893352|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||||||0.001
71688925|NCT02937636|142893353|OTHER||Least square (LS) mean difference|-0.09|||<|0.0001|TWO_SIDED|95.0|-0.12|-0.07|||ANCOVA|From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate.|Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment.|||-0.07|-0.12|<.0001
71924059|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|0.74|||TWO_SIDED|90.0|-0.12|2.33||||||||2.33|-0.12|
71924060|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|0.4|3.67||||||||3.67|0.40|
71924061|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|0.6|4.49||||||||4.49|0.60|
71924062|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|0.09|4.94||||||||4.94|0.09|
71924063|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.84|||TWO_SIDED|90.0|-1.62|4.47||||||||4.47|-1.62|
71924064|NCT03808298|143368685|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|1.6|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-0.1|3.39||||||||3.39|-0.10|
71924065|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 0.5 Hours Post-dose|LS Mean|0.8|STANDARD_ERROR_OF_MEAN|0.85|||TWO_SIDED|90.0|-0.6|2.2||||||||2.20|-0.60|
71924066|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 1 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|0.13|2.55||||||||2.55|0.13|
71924067|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 2.5 Hours Post-dose|LS Mean|1.7|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|0.04|3.27||||||||3.27|0.04|
71924068|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 4 Hours Post-dose|LS Mean|1.3|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-0.64|3.2||||||||3.20|-0.64|
71924069|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 8 Hours Post-dose|LS Mean|2.3|STANDARD_ERROR_OF_MEAN|1.45|||TWO_SIDED|90.0|-0.13|4.67||||||||4.67|-0.13|
71924070|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 12 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.82|||TWO_SIDED|90.0|-2.31|3.7||||||||3.70|-2.31|
71924071|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 1 24 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-1.35|2.1||||||||2.10|-1.35|
71924072|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.46|||TWO_SIDED|90.0|-2.94|1.89||||||||1.89|-2.94|
71924073|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.48|||TWO_SIDED|90.0|-3.19|1.72||||||||1.72|-3.19|
71688926|NCT03124537|142893423|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health||Tested whether weekly steps increased from the baseline week in both conditions (main effect of time).||||< .001
71688927|NCT03124537|142893423|SUPERIORITY|||||||0.846||||||Controlling for age, sex, education, and health.|Mixed Models Analysis|||Tested whether weekly step increases from the baseline week differed between the two conditions (time by condition interaction).||||.846
71924074|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.26|2.74||||||||2.74|-2.26|
71924075|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.51|||TWO_SIDED|90.0|-2.02|2.96||||||||2.96|-2.02|
71924076|NCT03808298|143368686|EQUIVALENCE|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 1 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.49|||TWO_SIDED|90.0|-2.39|2.54||||||||2.54|-2.39|
71924077|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.8|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-0.67|4.28||||||||4.28|-0.67|
71924078|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.11|3.31||||||||3.31|-2.11|
71924079|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 8 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-2.38|3.47||||||||3.47|-2.38|
71924080|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 12 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|2.11|||TWO_SIDED|90.0|-2.85|4.14||||||||4.14|-2.85|
71924081|NCT03808298|143368686|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at Day 14 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|1.5|||TWO_SIDED|90.0|-2.36|2.6||||||||2.60|-2.36|
71924082|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-1.2|0.73||||||||0.73|-1.20|
71924083|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.08|0.96||||||||0.96|-1.08|
71924084|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.73|0.78||||||||0.78|-1.73|
71924085|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.75|||TWO_SIDED|90.0|-1.8|0.7||||||||0.70|-1.80|
71924086|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.05|||TWO_SIDED|90.0|-2.42|1.05||||||||1.05|-2.42|
71924087|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.18|||TWO_SIDED|90.0|-2.66|1.24||||||||1.24|-2.66|
71924088|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-1.91|0.85||||||||0.85|-1.91|
71924089|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.9|-0.48||||||||-0.48|-3.90|
71924090|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-3.41|0.0||||||||0.00|-3.41|
71924091|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.08|||TWO_SIDED|90.0|-3.21|0.36||||||||0.36|-3.21|
71924092|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Pre-dose|LS Mean|-1.6|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-3.25|0.01||||||||0.01|-3.25|
71924093|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.36|-0.01||||||||-0.01|-3.36|
71924094|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.9|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-3.75|-0.14||||||||-0.14|-3.75|
71924095|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.4|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-3.06|0.29||||||||0.29|-3.06|
71924096|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.24|||TWO_SIDED|90.0|-3.08|1.01||||||||1.01|-3.08|
71688928|NCT03124537|142893424|SUPERIORITY|||||||0.571||||||Controlling for age, sex, condition, education, and health.|Mixed Models Analysis|||Tested whether exercise self-efficacy increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.571
71924097|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.03|0.76||||||||0.76|-3.03|
71924098|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.13|||TWO_SIDED|90.0|-2.87|0.87||||||||0.87|-2.87|
71924099|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 0.5 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.59|||TWO_SIDED|90.0|-0.89|1.07||||||||1.07|-0.89|
71924100|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 1 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.62|||TWO_SIDED|90.0|-1.21|0.86||||||||0.86|-1.21|
71924101|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 2.5 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|0.77|||TWO_SIDED|90.0|-1.71|0.83||||||||0.83|-1.71|
71924102|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 4 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.76|||TWO_SIDED|90.0|-1.07|1.46||||||||1.46|-1.07|
71924103|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 8 Hours Post-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.06|||TWO_SIDED|90.0|-2.5|1.0||||||||1.00|-2.50|
71924104|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 12 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|-2.22|1.74||||||||1.74|-2.22|
71924105|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 1 24 Hours Post-dose|LS Mean|-2.2|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-3.63|-0.85||||||||-0.85|-3.63|
71924106|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.75 Hours Pre-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.42|1.03||||||||1.03|-2.42|
71924107|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline Day 14 HR (bpm) at 0.5 Hours Pre-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|1.04|||TWO_SIDED|90.0|-2.96|0.49||||||||0.49|-2.96|
71924108|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.25 Hours Pre-dose|LS Mean|-0.8|STANDARD_ERROR_OF_MEAN|1.09|||TWO_SIDED|90.0|-2.58|1.02||||||||1.02|-2.58|
71924109|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 0.5 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|0.99|||TWO_SIDED|90.0|-2.34|0.95||||||||0.95|-2.34|
71924110|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 1 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.65|0.73||||||||0.73|-2.65|
71688929|NCT03124537|142893424|SUPERIORITY|||||||0.361|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise self efficacy increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.361
71924111|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 2.5 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.1|||TWO_SIDED|90.0|-3.11|0.53||||||||0.53|-3.11|
71924112|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 4 Hours Post-dose|LS Mean|-1.0|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.73|0.66||||||||0.66|-2.73|
71924113|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.25|||TWO_SIDED|90.0|-2.77|1.37||||||||1.37|-2.77|
71924114|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 12 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-2.5|1.33||||||||1.33|-2.50|
71924115|NCT03808298|143368687|OTHER|Placebo-corrected change-from-baseline HR (bpm) at Day 14 24 Hours Post-dose|LS Mean|-1.7|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.57|0.2||||||||0.20|-3.57|
71924116|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.83|||TWO_SIDED|90.0|-2.56|0.17||||||||0.17|-2.56|
71924117|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.96|||TWO_SIDED|90.0|-1.62|1.55||||||||1.55|-1.62|
71924118|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|1.0|||TWO_SIDED|90.0|-1.22|2.09||||||||2.09|-1.22|
71924119|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.4|STANDARD_ERROR_OF_MEAN|1.02|||TWO_SIDED|90.0|-2.04|1.33||||||||1.33|-2.04|
71924120|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.31|||TWO_SIDED|90.0|-1.0|3.33||||||||3.33|-1.00|
71924121|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.56|||TWO_SIDED|90.0|-2.3|2.88||||||||2.88|-2.30|
71924122|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|-1.1|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|-3.0|0.81||||||||0.81|-3.00|
71924123|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-2.08|3.35||||||||3.35|-2.08|
71924124|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.48|3.12||||||||3.12|-2.48|
71924125|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|1.69|||TWO_SIDED|90.0|-2.55|3.06||||||||3.06|-2.55|
71924126|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.9|||TWO_SIDED|90.0|-3.17|3.12||||||||3.12|-3.17|
71924127|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|90.0|-2.47|3.37||||||||3.37|-2.47|
71924128|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.74|||TWO_SIDED|90.0|-3.42|2.34||||||||2.34|-3.42|
71924129|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-3.54|2.12||||||||2.12|-3.54|
71688930|NCT03124537|142893425|SUPERIORITY|||||||0.564|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether exercise control increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.564
71688931|NCT03124537|142893425|SUPERIORITY|||||||0.641|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether exercise control belief increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.641
71688932|NCT03124537|142893427|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether daily walking was related to mood within-persons.||||< .001
71688933|NCT03124537|142893427|SUPERIORITY|||||||0.003|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether daily walking was related to energy within-persons.||||.003
71688934|NCT03124537|142893427|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, health, and average steps.||Tested whether the relationship between daily walking and mood differed between males and females (steps by sex interaction).||||< .001
71688935|NCT03124537|142893427|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Controlling for age, condition, education, health, and average steps.||Tested whether the relationship between daily walking and energy differed between males and females (steps by sex interaction).||||< .001
71688936|NCT03124537|142893428|SUPERIORITY|||||||0.011|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported vigorous physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.011
71688937|NCT03124537|142893428|SUPERIORITY|||||||0.232|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported vigorous physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.232
71688938|NCT03124537|142893429|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported moderate physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.530
71924130|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.57|||TWO_SIDED|90.0|-3.31|1.88||||||||1.88|-3.31|
71924131|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|90.0|-1.21|4.09||||||||4.09|-1.21|
71924132|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.63|||TWO_SIDED|90.0|-2.9|2.49||||||||2.49|-2.90|
71688939|NCT03124537|142893429|SUPERIORITY|||||||0.831|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported moderate physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.831
71688940|NCT03124537|142893430|SUPERIORITY|||||||0.199|||||||Mixed Models Analysis|Controlling for age, sex, condition, education, and health.||Tested whether self-reported light physical activity increased from the baseline week to the end of the intervention in both conditions (main effect of time).||||.199
71688941|NCT03124537|142893430|SUPERIORITY|||||||0.203|||||||Mixed Models Analysis|Controlling for age, sex, education, and health.||Tested whether self-reported light physical activity increases from the baseline to the end of the intervention differed between the two conditions (time by condition interaction).||||.203
71688942|NCT03681184|142893433|SUPERIORITY||Difference in Least Squares (LS) Mean|-53.546|STANDARD_ERROR_OF_MEAN|4.3224|<|0.0001|TWO_SIDED|95.0|-62.314|-44.778||P=1.685E-14|MMRM|||The Mixed-Effect Model Repeated Measures (MMRM) includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-44.778|-62.314|<0.0001
71688943|NCT03681184|142893434|SUPERIORITY||Difference in LS Mean|-0.975|STANDARD_ERROR_OF_MEAN|0.0998|<|0.0001|TWO_SIDED|95.0|-1.177|-0.772||P=1.225E-11|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate corrected for BSA as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-0.772|-1.177|<0.0001
71688944|NCT03681184|142893435|SUPERIORITY||Difference in LS Mean|-51.7718|STANDARD_ERROR_OF_MEAN|6.16118|<|0.0001|TWO_SIDED|95.0|-64.2653|-39.2784||P=5.032E-10|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline 24-hour urinary oxalate:creatinine ratio as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-39.2784|-64.2653|<0.0001
71688945|NCT03681184|142893436|SUPERIORITY||Difference in Proportions|0.84|||<|0.0001|TWO_SIDED|95.0|0.55|0.94||P=8.341E-07|Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤1.5 x ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.94|0.55|<0.0001
71924133|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.84|||TWO_SIDED|90.0|-2.0|0.77||||||||0.77|-2.00|
71924134|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 1 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.97|||TWO_SIDED|90.0|-1.71|1.5||||||||1.50|-1.71|
71924135|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 2.5 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.02||||90.0|-1.64|1.73||||||||1.73|-1.64|
71924136|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 4 Hours Post-dose|LS Mean|-0.7|STANDARD_ERROR_OF_MEAN|1.03|||TWO_SIDED|90.0|-2.39|1.02||||||||1.02|-2.39|
71924137|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 8 Hours Post-dose|LS Mean|0.9|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|90.0|-1.26|3.13||||||||3.13|-1.26|
71688946|NCT03681184|142893437|SUPERIORITY||Difference in Proportions|0.52||||0.001|TWO_SIDED|95.0|0.23|0.7|||Cochran-Mantel-Haenszel|||The proportion of participants (lumasiran vs. placebo) with 24-hour urinary oxalate ≤ULN at Month 6 is analyzed using the Cochran-Mantel-Haenszel test, stratified by baseline 24-hour urinary oxalate corrected for BSA (≤1.70 mmol/24hr/1.73m\^2 vs. \>1.70 mmol/24hr/1.73m\^2). The difference in proportion (lumasiran vs. placebo) and the corresponding 95% confidence interval are calculated using the Newcombe method, based on the Wilson score.||0.70|0.23|0.0010
71688947|NCT03681184|142893438|SUPERIORITY||Difference in LS Mean|-39.48|STANDARD_ERROR_OF_MEAN|5.181|<|0.0001|TWO_SIDED|95.0|-50.1|-28.87||P=2.862E-08|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-28.87|-50.10|<0.0001
71688948|NCT03681184|142893439|SUPERIORITY||Difference in LS Mean|-8.71|STANDARD_ERROR_OF_MEAN|1.338|<|0.0001|TWO_SIDED|95.0|-11.45|-5.98||P=3.893E-07|MMRM|||The MMRM includes fixed effects of treatment arms (lumasiran vs. placebo) and scheduled visits (months 3, 4, 5, and 6), baseline plasma oxalate as a continuous fixed covariate, and patient as a random effect. The variance-covariance matrix is assumed to be unstructured. Satterthwaite approximation is used to estimate denominator degrees of freedom.||-5.98|-11.45|<0.0001
71924138|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 12 Hours Post-dose|LS Mean|-1.3|STANDARD_ERROR_OF_MEAN|1.59||||90.0|-3.92|1.35||||||||1.35|-3.92|
71924139|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 1 24 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|1.16|||TWO_SIDED|90.0|-1.96|1.89||||||||1.89|-1.96|
71924140|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|1.4|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|-1.34|4.13||||||||4.13|-1.34|
71924141|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.61|4.05||||||||4.05|-1.61|
71924142|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|1.5|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.32|4.35||||||||4.35|-1.32|
71924143|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 0.5 Hours Post-dose|LS Mean|-0.2|STANDARD_ERROR_OF_MEAN|1.92|||TWO_SIDED|90.0|-3.38|2.97||||||||2.97|-3.38|
71924144|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 1 Hours Pre-dose|LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|1.78||||90.0|-3.48|2.42||||||||2.42|-3.48|
71924145|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 2.5 Hours Post-dose|LS Mean|1.1|STANDARD_ERROR_OF_MEAN|1.76|||TWO_SIDED|90.0|-1.81|4.02||||||||4.02|-1.81|
71924146|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 4 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.72|||TWO_SIDED|90.0|-1.67|4.04||||||||4.04|-1.67|
71924147|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 8 Hours Post-dose|LS Mean|0.7|STANDARD_ERROR_OF_MEAN|1.58|||TWO_SIDED|90.0|-1.95|3.29||||||||3.29|-1.95|
71924148|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 12 Hours Post-dose|LS Mean|3.3|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|90.0|0.6|5.96||||||||5.96|0.60|
71924149|NCT03808298|143368688|OTHER|Placebo-corrected change-from-baseline PR (ms) at Day 14 24 Hours Post-dose|LS Mean|2.0|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|-0.72|4.72||||||||4.72|-0.72|
71924150|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.29|0.07||||||||0.07|-0.29|
71924151|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.02|0.34||||||||0.34|-0.02|
71924152|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline (ms) at QRS Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.3|0.12||||||||0.12|-0.30|
71924153|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.26|0.18||||||||0.18|-0.26|
71924154|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.57|0.38||||||||0.38|-0.57|
71924155|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.65|0.56||||||||0.56|-0.65|
71924156|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.15||||90.0|-0.11|0.4||||||||0.40|-0.11|
71924157|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.34|0.74||||||||0.74|-0.34|
71924158|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.17|0.91||||||||0.91|-0.17|
71924159|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.04|1.05||||||||1.05|-0.04|
71924160|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.26|0.82||||||||0.82|-0.26|
71924161|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|32.0|||TWO_SIDED|90.0|-0.18|0.9||||||||0.90|-0.18|
71924162|NCT03808298|143368689|OTHER||LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.08|1.0||||||Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose||1.00|-0.08|
71924163|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.19|0.94||||||||0.94|-0.19|
71924164|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.43|||TWO_SIDED|90.0|-0.33|1.1||||||||1.10|-0.33|
71924165|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.47|||TWO_SIDED|90.0|-0.5|1.06||||||||1.06|-0.50|
71924166|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|90.0|-0.06|1.11||||||||1.11|-0.06|
71924167|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 0.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|-0.25|0.11||||||||0.11|-0.25|
71924168|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 1 Hours Post-dose|LS Mean|0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|90.0|0.0|0.36||||||||0.36|0.00|
71924169|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 2.5 Hours Post-dose|LS Mean|-0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.34|0.09||||||||0.09|-0.34|
71924170|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 4 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|90.0|-0.1|0.34||||||||0.34|-0.10|
71924171|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 8 Hours Post-dose|LS Mean|0.1|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|90.0|-0.4|0.57||||||||0.57|-0.40|
71924172|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.37|||TWO_SIDED|90.0|-0.31|0.93||||||||0.93|-0.31|
71924173|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 1 24 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|90.0|0.07|0.58||||||||0.58|0.07|
71924174|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.75 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.19|0.9||||||||0.90|-0.19|
71924175|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Pre-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.11|0.98||||||||0.98|-0.11|
71924176|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.25 Hours Pre-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.06|1.05||||||||1.05|-0.06|
71924177|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 0.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.27|0.82||||||||0.82|-0.27|
71924178|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 1 Hours Post-dose|LS Mean|0.4|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.14|0.94||||||||0.94|-0.14|
71924179|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 2.5 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.33|||TWO_SIDED|90.0|-0.24|0.86||||||||0.86|-0.24|
71924180|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 4 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|0.07|1.2||||||||1.20|0.07|
71924181|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 8 Hours Post-dose|LS Mean|0.6|STANDARD_ERROR_OF_MEAN|0.44|||TWO_SIDED|90.0|-0.1|1.35||||||||1.35|-0.10|
71924182|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 12 Hours Post-dose|LS Mean|0.3|STANDARD_ERROR_OF_MEAN|0.48|||TWO_SIDED|90.0|-0.5|1.07||||||||1.07|-0.50|
71924183|NCT03808298|143368689|OTHER|Placebo-corrected change-from-baseline QRS (ms) at Day 14 24 Hours Post-dose|LS Mean|0.5|STANDARD_ERROR_OF_MEAN|0.36|||TWO_SIDED|90.0|-0.14|1.04||||||||1.04|-0.14|
71924184|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 0.5 Hours Post-dose|LS Mean|1.2|STANDARD_ERROR_OF_MEAN|1.71|||TWO_SIDED|90.0|-1.64|4.04||||||||4.04|-1.64|
71924185|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 1 Hours Post-dose|LS Mean|5.4|STANDARD_ERROR_OF_MEAN|1.93|||TWO_SIDED|90.0|2.22|8.63||||||||8.63|2.22|
71924186|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 2.5 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.64|||TWO_SIDED|90.0|5.81|11.28||||||||11.28|5.81|
71924187|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 4 Hours Post-dose|LS Mean|8.6|STANDARD_ERROR_OF_MEAN|1.65|||TWO_SIDED|90.0|5.86|11.34||||||||11.34|5.86|
71924188|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 8 Hours Post-dose|LS Mean|8.5|STANDARD_ERROR_OF_MEAN|1.86|||TWO_SIDED|90.0|5.43|11.61||||||||11.61|5.43|
71924189|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 12 Hours Post-dose|LS Mean|6.9|STANDARD_ERROR_OF_MEAN|1.88|||TWO_SIDED|90.0|3.76|10.0||||||||10.00|3.76|
71924190|NCT03808298|143368711|OTHER|Placebo-corrected change-from-baseline QTcF (ms) at 24 Hours Post-dose|LS Mean|6.1|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|3.58|8.62||||||||8.62|3.58|
71924191|NCT03159455|143368718|OTHER||Slope|2.2305|STANDARD_ERROR_OF_MEAN|0.2592|||TWO_SIDED|95.0|1.6955|2.7655|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC0-24 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.7655|1.6955|
71924192|NCT03159455|143368719|OTHER||Slope|1.9007|STANDARD_ERROR_OF_MEAN|0.2382|||TWO_SIDED|95.0|1.4102|2.3912|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3912|1.4102|
71688949|NCT04424914|142893466|OTHER|||||||0.3006|||||||Chi-squared|p-values for comparison of proportions of CLASS I+II vs CLASS III+IV were based on a Chi-square test.||||||0.3006
71924193|NCT03159455|143368720|OTHER||Slope|3.244|STANDARD_ERROR_OF_MEAN|0.1771|||TWO_SIDED|95.0|2.8793|3.6087|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for AUC0-24,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|3.6087|2.8793|
71924194|NCT03159455|143368721|OTHER||Slope|2.0711|STANDARD_ERROR_OF_MEAN|0.148|||TWO_SIDED|95.0|1.7663|2.376|||||Dose proportionality was explored using the power model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing on Day 28 (after multiple doses). Dose proportionality of tablets for Cmax,28 was analysed in Japanese subjects.|Standard error of mean is standard error of slope.|2.3760|1.7663|
71924195|NCT05040295|143368723|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|102.5|||||TWO_SIDED|90.0|94.21|111.51|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||111.51|94.21|
71924196|NCT05040295|143368723|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|106.65|||||TWO_SIDED|90.0|100.07|113.66|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|AUCinf was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||113.66|100.07|
71924197|NCT05040295|143368724|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|101.12|||||TWO_SIDED|90.0|88.25|115.87|||||Reference = Treatment A Test = Treatment B Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||115.87|88.25|
71688950|NCT04424914|142893467|OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
71924198|NCT05040295|143368724|EQUIVALENCE|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Ratio of adjust geometric means|90.11|||||TWO_SIDED|90.0|78.49|103.44|||||Reference = Treatment A Test = Treatment C Ratio=Test/Reference|Cmax was analyzed using a mixed effects model with sequence and treatment as fixed effects and participant within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model.||103.44|78.49|
71924199|NCT00953849|143368727|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71924200|NCT00953849|143368728|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71924201|NCT00953849|143368729|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71688951|NCT04485637|142893468|SUPERIORITY||Odds Ratio (OR)|1.67|||=|0.05|TWO_SIDED|95.0|1.0|2.79|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||2.79|1.00|=0.05
71688952|NCT04485637|142893468|SUPERIORITY||Odds Ratio (OR)|1.66|||=|0.05|TWO_SIDED|95.0|1.0|2.76|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||2.76|1.00|=0.05
71688953|NCT04485637|142893469|SUPERIORITY|Enhanced table \> Basic table|Odds Ratio (OR)|1.52|||=|0.29|TWO_SIDED|95.0|0.71|3.26|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||3.26|0.71|=0.29
71688954|NCT04485637|142893469|SUPERIORITY|Enhanced graph \> Basic table|Odds Ratio (OR)|0.96|||=|0.9|TWO_SIDED|95.0|0.48|1.93|||Regression, Logistic|Adjusted for respondent characteristics as described in statistical analysis plan.||||1.93|0.48|=0.90
71688955|NCT04485637|142893470|SUPERIORITY||Unst|-0.14|||=|0.13|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced table \> Basic table||0.04|-0.32|=0.13
71688956|NCT04485637|142893470|SUPERIORITY||Unstandardized B|-0.14|||=|0.12|TWO_SIDED|95.0|-0.32|0.04|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||Enhanced graph \> Basic table||0.04|-0.32|=0.12
71924202|NCT00953849|143368730|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.||||||<0.05
71924203|NCT01801475|143368731|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
71924204|NCT01801475|143368732|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.||||<0.05
71688957|NCT04485637|142893471|SUPERIORITY|Enhanced table \> Basic table|Unstandardized B|-0.08|||=|0.33|TWO_SIDED|95.0|-0.25|0.08|||Regression, Linear|||||0.08|-0.25|=0.33
71688958|NCT04485637|142893471|SUPERIORITY||Unstandardized B|-0.09|||=|0.29|TWO_SIDED|95.0|-0.26|0.08|||Regression, Linear|Adjusted for respondent characteristics as described in statistical analysis plan.||||0.08|-0.26|=0.29
71688959|NCT00492232|142893517|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.71||||0.484||95.0|0.27|1.85||Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using the logistic regression analysis adjusted for effects of treatment and pooled center.||||1.85|0.27|0.484
71688960|NCT00492232|142893518|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.946||95.0|-6.23|5.81||P-values are from t-tests of the analysis of covariance (ANCOVA) model for the difference in least squares (LS) means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||5.81|-6.23|0.946
71688961|NCT00492232|142893519|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.901||95.0|-5.31|6.03||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.03|-5.31|0.901
71924205|NCT00444028|143368743|OTHER|"The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|Slope|0.909|||||TWO_SIDED|90.0|0.832|0.987||||||Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered.||0.987|0.832|
71924206|NCT05056311|143368748|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
71924207|NCT05056311|143368749|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
71924208|NCT05056311|143368750|SUPERIORITY|||||||0.001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.001
71924209|NCT05056311|143368752|SUPERIORITY|||||||0.0001||||||The a priori threshold for statistical significance was \<0.05.|t-test, 2 sided|||||||0.0001
71924210|NCT05056311|143368753|SUPERIORITY|||||||0.6374||||||The a priori threshold for statistical significance was \<0.05.|McNemar|||||||0.6374
71924211|NCT02713490|143368758|SUPERIORITY||LSMD|-26.884||||0.0381|TWO_SIDED|95.0|-56.608|2.841|||ANOVA|||||2.841|-56.608|0.0381
71924212|NCT02713490|143368759|SUPERIORITY||LSM treatment ratio|0.203||||0.0029|TWO_SIDED|95.0|0.065|0.631|||ANOVA|||||0.631|0.065|0.0029
71688962|NCT00492232|142893520|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.538||95.0|-4.32|8.23||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||8.23|-4.32|0.538
71688963|NCT00492232|142893521|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.517||95.0|-9.09|4.6||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||4.60|-9.09|0.517
71688964|NCT00492232|142893522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.965||95.0|-6.28|6.56||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg) and pooled center as covariates.||||6.56|-6.28|0.965
71924213|NCT02713490|143368760|SUPERIORITY||Treatment difference|0.098||||0.0088|TWO_SIDED|95.0|0.0284|0.1685|||Cochran-Mantel-Haenszel|||||0.1685|0.0284|0.0088
71924214|NCT02713490|143368761|SUPERIORITY|||||||0.023|||||||Log Rank|||Analysis applies to the overall distribution of time to first opioid rescue, estimated from Kaplan-Meier analysis.||||0.0230
71924215|NCT02713490|143368762|SUPERIORITY|||||||0.4285|||||||Kruskal-Wallis|||||||0.4285
71924216|NCT00346775|143368765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.517|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||||0.3|-0.6|0.517
71924217|NCT01714726|143368769|SUPERIORITY||Risk Difference (RD)|22.5|||=|0.01|TWO_SIDED|90.0|8.3|36.8|||Regression, Logistic|||||36.8|8.3|=0.01
71924218|NCT02748096|143368788|OTHER||||||<|0.05||||||A p value of less than 0.05 was considered statistically significant for all the radiographic parameters .|t-test, 2 sided|This test applies to comparison between the two treatment arms and assesses all the radiographic parameters||The sample size was calculated from a previous study that used similar radiological assessments to compare OUKAs performed using conventional instrumentation and computer navigation. In this study, the standard deviation of the tibia varus/valgus angle for the control group was 3.6°. Assuming a minimum clinically important difference of 3°, the SMD would be 0.8. Hence with a power of 0.8 and significance level of 0.05, a total sample size of 44 patients (22 in each group) was required.||||<0.05
71924219|NCT02748096|143368789|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71924220|NCT02748096|143368790|OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71924221|NCT01545375|143368801|SUPERIORITY|The objective was to demonstrate that VE induced by GSK2189242A vaccine (three doses in the first year of life and a booster dose in the second year of life)in preventing clinical AOM diagnosed and verified against AAP criteria was greater than 0%, as compared to the control group. One-sided p-value for the Wald-Test obtained from the general Cox proportional hazard model was calculated.|Vaccine Efficacy|3.81||||0.3016|TWO_SIDED|95.0|-11.35|16.9||The primary objective was met if the one-sided p-value calculated for the null hypothesis H0=\[clinical AOM VE ≤ 0%\] was lower than defined 1-sided alpha level: (17.8%).|Regression, Cox|||VE-AOM against AAP criteria: Occurrence of AOM during efficacy follow-up period was compared between groups to estimate Vaccine Efficacy (VE) and its 95% confidence interval using the Anderson \& Gill model (generalization of Cox proportional hazard model) taking into account for recurrent events \[Kelly, 2000\]. VE= (1 - hazard ratio) x 100 Censoring occurred at the time of the last scheduled or medically attended visit.||16.90|-11.35|0.3016
71924222|NCT06045026|143368892|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924223|NCT06045026|143368892|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924224|NCT06045026|143368892|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924225|NCT06045026|143368892|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924226|NCT06045026|143368892|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924227|NCT06045026|143368892|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924228|NCT06045026|143368893|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924229|NCT06045026|143368893|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924230|NCT06045026|143368893|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924231|NCT06045026|143368893|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924232|NCT06045026|143368893|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924233|NCT06045026|143368893|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924234|NCT06045026|143368894|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924235|NCT06045026|143368894|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924236|NCT06045026|143368894|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924237|NCT06045026|143368894|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924238|NCT06045026|143368894|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924239|NCT06045026|143368894|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924240|NCT06045026|143368895|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924241|NCT06045026|143368895|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924242|NCT06045026|143368895|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924243|NCT06045026|143368895|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924244|NCT06045026|143368895|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924245|NCT06045026|143368895|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924246|NCT06045026|143368896|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924247|NCT06045026|143368896|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924248|NCT06045026|143368896|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924249|NCT06045026|143368896|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924250|NCT06045026|143368896|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924251|NCT06045026|143368896|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924252|NCT06045026|143368897|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924253|NCT06045026|143368897|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924254|NCT06045026|143368897|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924255|NCT06045026|143368897|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924256|NCT06045026|143368897|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924257|NCT06045026|143368897|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924258|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 4||||<0.0001
71924259|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 8||||<0.0001
71924260|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 12||||<0.0001
71924261|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 16||||<0.0001
71924262|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 20||||<0.0001
71924263|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q1 (How intense are the sensations?): Change from Baseline at Week 24||||<0.0001
71924264|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 4||||<0.0001
71924265|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 8||||<0.0001
71924266|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 12||||<0.0001
71924267|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 16||||<0.0001
71924268|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 20||||<0.0001
71924269|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q2 (How bothered are you by any sensations?): Change from Baseline at Week 24||||<0.0001
71924270|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 4||||<0.0001
71924271|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 8||||<0.0001
71924272|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 12||||<0.0001
71924273|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 16||||<0.0001
71924274|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 20||||<0.0001
71924275|NCT06045026|143368898|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Q3 (How well can you tolerate sensations?): Change from Baseline at Week 24||||<0.0001
71924276|NCT06045026|143368899|SUPERIORITY|||||||0.01|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||0.0100
71924277|NCT06045026|143368899|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924278|NCT06045026|143368899|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924279|NCT06045026|143368899|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924280|NCT06045026|143368899|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924281|NCT06045026|143368899|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924282|NCT06045026|143368900|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924283|NCT06045026|143368900|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924284|NCT06045026|143368900|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924285|NCT06045026|143368900|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924286|NCT06045026|143368900|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924287|NCT06045026|143368900|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924288|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 1||||<0.0001
71924289|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 2||||<0.0001
71924290|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 4||||<0.0001
71924291|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 8||||<0.0001
71924292|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 12||||<0.0001
71924293|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 16||||<0.0001
71924294|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 20||||<0.0001
71924295|NCT06045026|143368902|SUPERIORITY||||||<|0.0001|||||||Mixed Model with Repeated Measures|||Change from Baseline at Week 24||||<0.0001
71924296|NCT01399619|143368905|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||p-value corresponds to a two sided test against the historical rate of 40%.|normal approximation|||the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.||||<0.0001
71924297|NCT00399542|143368932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||70.6% improvement in response with lubiprostone at 90% statistical power||||0.023
71924298|NCT00399542|143368933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.391|||||||van Elteren nonparametric test|Adjusted for center||||||0.391
71924299|NCT00399542|143368934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.151|||||||van Elteren nonparametric test|Adjusted for center||||||0.151
71924300|NCT00399542|143368935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.163|||||||van Elteren nonparametric test|Adjusted for center||||||0.163
71924301|NCT00399542|143368936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.185|||||||van Elteren nonparametric test|Adjusted for center||||||0.185
71924302|NCT00399542|143368937|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Cochran-Mantel-Haenszel|||||||0.300
71924303|NCT00399542|143368938|SUPERIORITY_OR_OTHER_LEGACY|||||||0.303||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.303
71924304|NCT00399542|143368939|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.047
71924305|NCT00399542|143368940|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||||||0.008
71924306|NCT00399542|143368941|SUPERIORITY_OR_OTHER_LEGACY|||||||0.663|||||||van Elteren nonparametric test|Adjusted for center||||||0.663
71924307|NCT00399542|143368942|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224|||||||van Elteren nonparametric test|Adjusted for center||||||0.224
71924308|NCT00399542|143368943|SUPERIORITY_OR_OTHER_LEGACY|||||||0.271|||||||van Elteren nonparametric test|Adjusted for center||||||0.271
71924309|NCT00399542|143368944|SUPERIORITY_OR_OTHER_LEGACY|||||||0.945|||||||van Elteren nonparametric test|Adjusted for center||||||0.945
71924310|NCT00399542|143368945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.352|||||||van Elteren nonparametric test|||||||0.352
71924311|NCT00399542|143368946|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18|||||||van Elteren nonparametric test|Adjusted for center||||||0.180
71924312|NCT00399542|143368947|SUPERIORITY_OR_OTHER_LEGACY|||||||0.275|||||||van Elteren nonparametric test|Adjusted for center||||||0.275
71924313|NCT00399542|143368948|SUPERIORITY_OR_OTHER_LEGACY|||||||0.722|||||||van Elteren nonparametric test|Adjusted for center||||||0.722
71924314|NCT00399542|143368949|SUPERIORITY_OR_OTHER_LEGACY|||||||0.177|||||||van Elteren nonparametric test|Adjusted for center||||||0.177
71924315|NCT00399542|143368950|SUPERIORITY_OR_OTHER_LEGACY|||||||0.082|||||||van Elteren nonparametric test|Adjusted for center||||||0.082
71924316|NCT00399542|143368951|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11|||||||van Elteren nonparametric test|Adjusted for center||||||0.110
71924317|NCT00399542|143368952|SUPERIORITY_OR_OTHER_LEGACY|||||||0.146|||||||van Elteren nonparametric test|Adjusted for center||||||0.146
71924318|NCT00399542|143368953|SUPERIORITY_OR_OTHER_LEGACY|||||||0.373|||||||van Elteren nonparametric test|Adjusted for center||||||0.373
71924319|NCT00399542|143368954|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|||||||van Elteren nonparametric test|Adjusted for center||||||0.339
71924320|NCT00399542|143368955|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023|||||||Cochran-Mantel-Haenszel|||||||0.023
71924321|NCT00399542|143368956|SUPERIORITY_OR_OTHER_LEGACY|||||||0.073|||||||Cochran-Mantel-Haenszel|||||||0.073
71924322|NCT00399542|143368957|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||ANCOVA|Adjusted for center||||||0.062
71924323|NCT00399542|143368958|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06|||||||van Elteren nonparametric test|||||||0.060
71924324|NCT00399542|143368959|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||van Elteren nonparametric test|||||||0.290
71924325|NCT00399542|143368960|SUPERIORITY_OR_OTHER_LEGACY|||||||0.495|||||||van Elteren nonparametric test|||||||0.495
71924326|NCT01830621|143368994|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.337|TWO_SIDED|95.0|0.88|1.46|||Log Rank|||||1.46|0.88|0.337
71924327|NCT01830621|143368995|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.837|TWO_SIDED|95.0|0.76|1.26|||Log Rank|||||1.26|0.76|0.837
71924328|NCT01830621|143368996|SUPERIORITY||Odds Ratio (OR)|0.98||||0.955|TWO_SIDED|95.0|0.48|2.0|||Cochran-Mantel-Haenszel|||||2.00|0.48|0.955
71924329|NCT01830621|143368998|SUPERIORITY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71924330|NCT03026556|143369036|OTHER||Hazard Ratio (HR)|0.766||||0.0844|TWO_SIDED|95.0|0.566|1.037|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.037|0.566|0.0844
71924331|NCT03026556|143369036|OTHER||Hazard Ratio (HR)|1.255||||0.4892|TWO_SIDED|95.0|0.659|2.39|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.390|0.659|0.4892
71924332|NCT03026556|143369037|OTHER||Hazard Ratio (HR)|0.82||||0.0182|TWO_SIDED|95.0|0.696|0.967|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.967|0.696|0.0182
71924333|NCT03026556|143369037|OTHER||Hazard Ratio (HR)|1.374||||0.0702|TWO_SIDED|95.0|0.974|1.939|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.939|0.974|0.0702
71924334|NCT03026556|143369038|OTHER||Hazard Ratio (HR)|0.923||||0.6307|TWO_SIDED|95.0|0.667|1.278|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.278|0.667|0.6307
71924335|NCT03026556|143369038|OTHER||Hazard Ratio (HR)|1.054||||0.8777|TWO_SIDED|95.0|0.54|2.055|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.055|0.540|0.8777
71924336|NCT03026556|143369039|OTHER||Hazard Ratio (HR)|0.223||||0.0023|TWO_SIDED|95.0|0.085|0.585|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.585|0.085|0.0023
71924337|NCT03026556|143369040|OTHER||Hazard Ratio (HR)|0.654||||0.0406|TWO_SIDED|95.0|0.435|0.982|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||0.982|0.435|0.0406
71924338|NCT03026556|143369040|OTHER||Hazard Ratio (HR)|1.11||||0.8124|TWO_SIDED|95.0|0.469|2.63|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.630|0.469|0.8124
71924339|NCT03026556|143369041|OTHER||Hazard Ratio (HR)|0.856||||0.0901|TWO_SIDED|95.0|0.716|1.025|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.025|0.716|0.0901
71924340|NCT03026556|143369041|OTHER||Hazard Ratio (HR)|1.431||||0.0616|TWO_SIDED|95.0|0.983|2.083|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.083|0.983|0.0616
71924341|NCT03026556|143369042|OTHER||Hazard Ratio (HR)|0.887||||0.2073|TWO_SIDED|95.0|0.736|1.069|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.069|0.736|0.2073
71924342|NCT03026556|143369042|OTHER||Hazard Ratio (HR)|1.504||||0.0417|TWO_SIDED|95.0|1.015|2.228|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.228|1.015|0.0417
71924343|NCT03026556|143369044|OTHER||Hazard Ratio (HR)|0.709||||0.2663|TWO_SIDED|95.0|0.387|1.299|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.299|0.387|0.2663
71924344|NCT03026556|143369044|OTHER||Hazard Ratio (HR)|0.864||||0.8112|TWO_SIDED|95.0|0.261|2.863|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.863|0.261|0.8112
71924345|NCT03026556|143369045|OTHER||Hazard Ratio (HR)|0.766||||0.1227|TWO_SIDED|95.0|0.546|1.075|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.075|0.546|0.1227
71924346|NCT03026556|143369045|OTHER||Hazard Ratio (HR)|1.138||||0.7115|TWO_SIDED|95.0|0.573|2.26|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.260|0.573|0.7115
71924347|NCT03026556|143369046|OTHER||Hazard Ratio (HR)|0.923||||0.4727|TWO_SIDED|95.0|0.741|1.149|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.149|0.741|0.4727
71924348|NCT03026556|143369046|OTHER||Hazard Ratio (HR)|1.721||||0.0275|TWO_SIDED|95.0|1.062|2.79|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.790|1.062|0.0275
71924349|NCT03026556|143369047|OTHER||Hazard Ratio (HR)|1.346||||0.2309|TWO_SIDED|95.0|0.828|2.189|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||2.189|0.828|0.2309
71924350|NCT03026556|143369047|OTHER||Hazard Ratio (HR)|1.557||||0.3333|TWO_SIDED|95.0|0.635|3.821|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||3.821|0.635|0.3333
71924351|NCT03026556|143369048|OTHER||Hazard Ratio (HR)|1.008||||0.9359|TWO_SIDED|95.0|0.829|1.226|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.226|0.829|0.9359
71924352|NCT03026556|143369048|OTHER||Hazard Ratio (HR)|1.024||||0.8947|TWO_SIDED|95.0|0.716|1.465|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||1.465|0.716|0.8947
71924353|NCT01294319|143369049|SUPERIORITY|||||||0.4872|||||||Fisher Exact|||||||0.4872
71924354|NCT01294319|143369050|SUPERIORITY|||||||0.2786|||||||t-test, 2 sided|||||||0.2786
71924355|NCT02924129|143369051|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||Significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71924356|NCT02924129|143369052|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|9.0|||<|0.001|TWO_SIDED|95.0|-2.4|20.4||significance threshold (α) of 0.05|t-test, 2 sided|||||20.4|-2.4|<0.001
71924357|NCT02924129|143369053|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|14.6|||<|0.001|TWO_SIDED|95.0|2.9|26.3||significance threshold (α) of 0.05|t-test, 2 sided|||||26.3|2.9|<0.001
71924358|NCT02924129|143369054|NON_INFERIORITY|non-inferiority margin (δ) of 10%||||||0.002||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||0.002
71924359|NCT02924129|143369055|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71924360|NCT02924129|143369056|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71924361|NCT02924129|143369057|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|10.7|||<|0.001|TWO_SIDED|95.0|-1.8|23.3||significance threshold (α) of 0.05|t-test, 2 sided|||||23.3|-1.8|<0.001
71924362|NCT02924129|143369058|NON_INFERIORITY|non-inferiority margin (δ) of 10%|Mean Difference (Final Values)|15.4|||<|0.001|TWO_SIDED|95.0|2.5|28.3||significance threshold (α) of 0.05|t-test, 2 sided|||||28.3|2.5|<0.001
71924363|NCT02924129|143369059|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001|||||||normal approximation to the binomial|||||||<0.001
71924364|NCT02924129|143369060|NON_INFERIORITY|non-inferiority margin (δ) of 10%|||||<|0.001||||||significance threshold (α) of 0.05|normal approximation to the binomial|||||||<0.001
71924365|NCT01000311|143369082|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|83.0|||||TWO_SIDED|95.0|83.0|93.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.||93|83|
71688965|NCT00492232|142893523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.617||95.0|-0.27|0.45||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.45|-0.27|0.617
71688966|NCT00492232|142893524|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.541||95.0|-0.39|0.74||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||0.74|-0.39|0.541
71688967|NCT00492232|142893525|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.55||||0.163||95.0|-0.23|1.33||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.33|-0.23|0.163
71688968|NCT00492232|142893526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.757||95.0|-0.79|1.08||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.08|-0.79|0.757
71688969|NCT00492232|142893527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.82||95.0|-0.93|1.17||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs \>10 mg), baseline zolpidem frequency, and pooled center as covariates.||||1.17|-0.93|0.820
71688970|NCT00492232|142893529|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|2.01||||0.284||95.0|0.55|7.34||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||7.34|0.55|0.284
71688971|NCT00492232|142893530|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|1.42||||0.389||95.0|0.64|3.13||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs \>10 mg).||||3.13|0.64|0.389
71924366|NCT01000311|143369082|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|90.0|||||TWO_SIDED|95.0|90.0|98.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.||98|90|
71924367|NCT01000311|143369082|SUPERIORITY_OR_OTHER||Lower limit of 95% confidence interval|93.0|||||TWO_SIDED|95.0|93.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup W.||99|93|
71924368|NCT01000311|143369082|SUPERIORITY_OR_OTHER||Lowe limit of 95% confidence interval|92.0|||||TWO_SIDED|95.0|92.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup Y.||99|92|
71924369|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to diphtheria toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.9|2.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||2.6|-2.9|
71924370|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to tetanus toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-3.3|3.9|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||3.9|-3.3|
71924371|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-12.1|4.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone||4.3|-12.1|
71924372|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis (FHA antigen), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|4.0|||||TWO_SIDED|95.0|-5.1|13.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||13.6|-5.1|
71924373|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis pertactin antigen, when DTaP vaccine is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-8.8|9.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.||9.1|-8.8|
71924374|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-2.0|||||TWO_SIDED|95.0|-10.6|6.8|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone||6.8|-10.6|
71688972|NCT02453256|142893531|SUPERIORITY||Difference in least square means|-1.73||||0.0983|TWO_SIDED|95.0|-3.78|0.32|||Repeated Measure|||Difference in least square means between the TCZ group and the Placebo group at week 48. Null hypothesis: There is no difference between the TCZ group and the placebo group in mean change in mRSS from baseline to Week 48.||0.32|-3.78|0.0983
71688973|NCT02453256|142893532|SUPERIORITY||Weighted difference|21.91||||0.0007|TWO_SIDED|95.0|9.2|34.6|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 20% improvement in mRSS.||34.6|9.2|0.0007
71688974|NCT02453256|142893532|SUPERIORITY||Weighted difference|4.32||||0.5139|TWO_SIDED|95.0|-8.7|17.3|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 40% improvement in mRSS.||17.3|-8.7|0.5139
71924375|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to hepatitis B, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of hepatitis B vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-5.2|4.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.||4.5|-5.2|
71924376|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to Hib vaccine, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of Hib vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|5.0|||||TWO_SIDED|95.0|0.0|11.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.||11.2|0|
71924377|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 1), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-3.1|5.4|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||5.4|-3.1|
71924378|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 2), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.4|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||3|-1.4|
71924379|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to polio antigen (Type 3), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|-1.0|||||TWO_SIDED|95.0|-3.3|1.7|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone||1.7|-3.3|
71924380|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|1.0|||||TWO_SIDED|95.0|-1.9|4.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||4.6|-1.9|
71924381|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||TWO_SIDED|95.0|-10.3|3.2|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.2|-10.3|
71924382|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-8.7|2.3|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||2.3|-8.7|
71924383|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||TWO_SIDED|95.0|-2.8|3.0|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||3.0|-2.8|
71688975|NCT02453256|142893532|SUPERIORITY||Weighted difference|-5.41||||0.3276|TWO_SIDED|95.0|-16.2|5.4|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 60% improvement in mRSS.||5.4|-16.2|0.3276
71688976|NCT02453256|142893533|SUPERIORITY|||||||0.0015||||||P-value from Van Elteren analysis stratified by IL-6 level (\<10; \>=10 pg/mL) at screening.|Van Elteren|||||||0.0015
71688977|NCT02453256|142893534|SUPERIORITY||Difference in least square means|0.167||||0.0001|TWO_SIDED|95.0|0.083|0.25|||Repeated Measure|||||0.250|0.083|0.0001
71924384|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||TWO_SIDED|95.0|-7.3|1.6|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||1.6|-7.3|
71924385|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|3.0|||||TWO_SIDED|95.0|1.3|7.1|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||7.1|1.3|
71924386|NCT01000311|143369086|NON_INFERIORITY_OR_EQUIVALENCE|The immune seroresponse to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-5.0|||||TWO_SIDED|95.0|-11.4|0.5|||Miettinen and Nurminen|||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone||0.5|-11.4|
71924387|NCT01000311|143369087|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.02|||||TWO_SIDED|95.0|0.81|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone||1.28|0.81|
71924388|NCT01000311|143369087|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FHA antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.9|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.19|0.9|
71924389|NCT01000311|143369087|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis pertactin antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.28|0.84|
71924390|NCT01000311|143369087|NON_INFERIORITY_OR_EQUIVALENCE|The immune response measured as GMC of antibodies to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.09|||||TWO_SIDED|95.0|0.88|1.35|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone||1.35|0.88|
71924391|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.98|||||TWO_SIDED|95.0|0.8|1.19|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.19|0.8|
71924392|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.76|||||TWO_SIDED|95.0|0.62|0.93|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||0.93|0.62|
71924393|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.87|||||TWO_SIDED|95.0|0.72|1.06|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.06|0.72|
71924394|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|1.04|||||TWO_SIDED|95.0|0.84|1.28|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.28|0.84|
71924395|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.99|||||TWO_SIDED|95.0|0.82|1.2|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.2|0.82|
71924396|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.89|||||TWO_SIDED|95.0|0.73|1.07|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.07|0.73|
71924397|NCT01000311|143369088|NON_INFERIORITY_OR_EQUIVALENCE|The immune response as GMC of antibodies to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.84|||||TWO_SIDED|95.0|0.68|1.04|||ANOVA|||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone||1.04|0.68|
71924398|NCT02780869|143369094|NON_INFERIORITY|The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™- G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ \> -0.10 using a one-sided level 0.025 test.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.||||||<0.0001
71924399|NCT02780869|143369094|SUPERIORITY|||||||0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Cochran-Mantel-Haenszel|||A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.||||0.0001
71924400|NCT02780869|143369095|SUPERIORITY||||||<|0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Regression, Linear|||The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.||||<0.0001
71924401|NCT02780869|143369096|NON_INFERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.|||||<|0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||<0.0001
71924402|NCT02780869|143369096|SUPERIORITY|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.||||||0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic|||||||0.0001
71924403|NCT01377194|143369168|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.303||||0.0027|TWO_SIDED|95.0|-5.457|-1.148|||mixed-model for repeated measures|||||-1.148|-5.457|0.0027
71924404|NCT01377194|143369168|SUPERIORITY_OR_OTHER||Least squares mean difference|-3.141||||0.0043|TWO_SIDED|95.0|-5.293|-0.988|||mixed-model for repeated measures|||||-0.988|-5.293|0.0043
71924405|NCT01377194|143369169|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.827||||0.0459|TWO_SIDED|95.0|-3.62|-0.033|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.033|-3.620|0.0459
71924406|NCT01377194|143369169|SUPERIORITY_OR_OTHER||Least squares mean difference|-2.72||||0.0028|TWO_SIDED|95.0|-4.494|-0.946|||Mixed Models Analysis|Mixed-effects model for repeated measures.||||-0.946|-4.494|0.0028
71924407|NCT02138227|143369184|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71924408|NCT02138227|143369185|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|F (2, 1574)||||||<0.01
71924409|NCT00960869|143369192|SUPERIORITY_OR_OTHER||proportions|2.7||||0.005|TWO_SIDED|95.0|1.1|5.5|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.||5.5|1.1|0.005
71924410|NCT00960869|143369193|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71924411|NCT00960869|143369194|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71688978|NCT02453256|142893535|SUPERIORITY||Difference in least square means|-0.053||||0.4489|TWO_SIDED|95.0|-0.192|0.085|||Repeated Measure|||||0.085|-0.192|0.4489
71924412|NCT00960869|143369195|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71924413|NCT00960869|143369196|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||||<0.001
71924414|NCT01153971|143369215|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71924415|NCT03410693|143369233|SUPERIORITY||ORR difference (R-C)|-2.1|||=|0.6991|TWO_SIDED|95.0|-14.0|9.9|||Fisher Exact|||||9.9|-14.0|=0.6991
71924416|NCT03410693|143369233|SUPERIORITY||ORR difference (R - C)|-4.5|||=|0.7944|TWO_SIDED|95.0|-18.9|9.9|||Fisher Exact|||||9.9|-18.9|=0.7944
71924417|NCT03410693|143369234|SUPERIORITY||DCR difference (R-C)|-5.1|||=|0.7962|TWO_SIDED|95.0|-19.9|9.7|||Fisher Exact|||||9.7|-19.9|=0.7962
71924418|NCT03410693|143369234|SUPERIORITY||DCR difference (R-C)|-10.3|||=|0.9109|TWO_SIDED|95.0|-27.5|6.9|||Fisher Exact|||||6.9|-27.5|=0.9109
71924419|NCT03410693|143369235|SUPERIORITY||Hazard Ratio (HR)|1.226|||=|0.8672|TWO_SIDED|95.0|0.853|1.762|||Log Rank|||||1.762|0.853|= 0.8672
71924420|NCT03410693|143369235|SUPERIORITY||Hazard Ratio (HR)|1.341||||0.9171|TWO_SIDED|95.0|0.88|2.043|||Log Rank|||||2.043|0.880|0.9171
71924421|NCT03628781|143369511|SUPERIORITY||Odds Ratio (OR)|0.384||||0.535|TWO_SIDED||||||Chi-squared|||||||.535
71924422|NCT03628781|143369512|SUPERIORITY||Slope|0.018|STANDARD_ERROR_OF_MEAN|0.081||0.829|TWO_SIDED||||||ANOVA|||||||.829
71924423|NCT03628781|143369513|SUPERIORITY||Slope|-0.105|STANDARD_ERROR_OF_MEAN|0.093||0.357|TWO_SIDED||||||ANOVA|||||||.357
71924424|NCT03628781|143369514|SUPERIORITY||Slope|-0.035|STANDARD_ERROR_OF_MEAN|0.126||0.782|TWO_SIDED||||||ANOVA|||||||.782
71924425|NCT00656669|143369515|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|||||||t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of sunitinib monotherapy||From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.||||0.0001
71924426|NCT00656669|143369516|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7963||||||a priori threshold of \<0.05|t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of paxlitaxel+sunitinib treatment||||||0.7963
71924427|NCT03778021|143369519|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|0.093||0.017|TWO_SIDED|95.0|0.04|0.41||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05."|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change (intervention minus control) from repeated measures linear mixed model|"The unit of measure is score on a scale. The results show the least squares estimate of change in that score, from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|"In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured)."|0.41|0.04|0.017
71924428|NCT03778021|143369520|SUPERIORITY||Mean Difference (Net)|1.41||||0.18|TWO_SIDED|95.0|-0.66|3.49||"Estimated differential change in score between intervention and comparison group from repeated measures linear mixed model.~All the reported analyses conservatively specified covariance structure as general covariance (unstructured). alpha = 0.05"|Mixed Models Analysis|Repeated measures linear mixed model analysis. Student nested within school. Model fit time, intervention and time by intervention interaction.|Estimated differential change from baseline to follow-up from model (intervention minus control)|"Results present estimated change in score from baseline to 8-month follow-up in each group from model.~Values from the 100 and 194 baseline respondents and from the 72 and 141 follow-up respondents of intervention and comparison groups respectively contributed to the repeated measures linear mixed model, where the units of analysis were participant-time. The nesting within schools was accounted for in the model."|In the repeated measures linear mixed model, time was treated as a fixed effect. In the specification of the repeated measures linear mixed model, students were nested within schools|3.49|-0.66|0.18
71688979|NCT02453256|142893536|SUPERIORITY||Difference in least square means|-2.44||||0.4339|TWO_SIDED|95.0|-8.57|3.7|||Repeated Measure|||||3.70|-8.57|0.4339
71688980|NCT02453256|142893537|SUPERIORITY||Difference in least square means|-2.46||||0.4378|TWO_SIDED|95.0|-8.72|3.79|||Repeated Measure|||||3.79|-8.72|0.4378
71688981|NCT02453256|142893538|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.0821|TWO_SIDED|95.0|0.37|1.06|||Cox-proportional hazards model|||||1.06|0.37|0.0821
71688982|NCT00636636|142893589|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.2||0.0125|TWO_SIDED|95.0|-0.88|-0.11|||ANCOVA|||||-0.11|-0.88|0.0125
71924429|NCT03778021|143369521|SUPERIORITY||Odds Ratio (OR)|1.29||||0.51|TWO_SIDED|95.0|0.6|2.81||"Repeated measures generalized linear mixed model with binomial distribution (variable was I know I can - yes versus no)."|Mixed Models Analysis|The odds of the odds ratio is reported as the intervention effect.|Odds ratio from estimated least squares from generalized mixed model with binomial distribution specified. Intervention odds of change compared to comparison group odds of change via odds ratio..|"Odds ratio of 8-month follow-up to baseline percent reporting  I know I can was estimated from repeated measures generalized linear mixed model with binomial distribution.~Values included from the 100 and 194 baseline respondents and from the 72 and 141 8-month follow-up respondents of intervention and comparison groups respectively. The person-timepoint is the unit of analysis."||2.81|0.60|0.51
71924430|NCT02687815|143369537|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.63|TWO_SIDED|95.0|0.69|1.85|||Regression, Cox|||||1.85|0.69|0.63
71924431|NCT02687815|143369538|SUPERIORITY||Hazard Ratio (HR)|1.32||||0.46|TWO_SIDED|95.0|0.63|2.75|||Regression, Cox|||||2.75|0.63|0.46
71924432|NCT02687815|143369539|SUPERIORITY||Odds Ratio (OR)|0.99||||0.99|TWO_SIDED|95.0|0.66|1.52|||Regression, Logistic|||||1.52|0.66|0.99
71924433|NCT02687815|143369540|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.049|TWO_SIDED|95.0|0.001|8.8|||Regression, Linear|||||8.80|0.001|0.049
71924434|NCT02558634|143369541|SUPERIORITY||Median Difference (Final Values)|1.25||||0.025|TWO_SIDED|95.0|0.75|1.75||The level of significance was set at p=0.025 to allow a Bonferroni correction for these two tests (i.e. p=0.050 divided by two).|Wilcoxon (Mann-Whitney)|||||1.75|0.75|0.025
71924435|NCT01224171|143369553|SUPERIORITY_OR_OTHER||Risk Difference (RD)|3.0||||0.4332|TWO_SIDED|95.0|-4.5|10.5|||Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine \[6-MP\], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.||10.5|-4.5|0.4332
71688983|NCT00636636|142893590|SUPERIORITY_OR_OTHER||Difference in proportion|0.092||||0.0434|TWO_SIDED|95.0|0.0|0.18|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in PGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.18|-0.00|0.0434
71924436|NCT03737812|143369562|OTHER|a statistical test was not performed|Odds Ratio (OR)|2.23|||||TWO_SIDED|95.0|0.485|10.259||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||10.259|0.485|
71924437|NCT03737812|143369562|OTHER|a statistical test was not performed|Odds Ratio (OR)|3.859|||||TWO_SIDED|95.0|0.899|16.561||||||Analyzed using a logistic regression model with corresponding baseline value as a covariate and treatment as a main effect. Logistic regression model for EDSS+ includes baseline values for EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant, 9-Hole Peg Test-nondominant, and treatment as a main effect. Subjects with missing values were imputed as non-responders.||16.561|0.899|
71924438|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|5.83|STANDARD_ERROR_OF_MEAN|18.332||0.6241|TWO_SIDED|95.0|-31.05|42.71||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||42.71|-31.05|0.6241
71924439|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|11.87|STANDARD_ERROR_OF_MEAN|19.081||0.7315|TWO_SIDED|95.0|-26.52|50.26||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||50.26|-26.52|0.7315
71924440|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|18.566||0.6212|TWO_SIDED|95.0|-31.65|43.18||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||43.18|-31.65|0.6212
71924441|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|20.662||0.5987|TWO_SIDED|95.0|-36.44|46.84||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.||46.84|-36.44|0.5987
71924442|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Median Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|18.114||0.482|TWO_SIDED|95.0|-37.28|35.64||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||35.64|-37.28|0.4820
71924443|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|19.9|STANDARD_ERROR_OF_MEAN|18.496||0.8562|TWO_SIDED|95.0|-17.33|57.13||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||57.13|-17.33|0.8562
71924444|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|18.3||0.488|TWO_SIDED|95.0|-37.46|36.35||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||36.35|-37.46|0.4880
71924445|NCT00612456|143369592|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|20.008||0.7556|TWO_SIDED|95.0|-26.38|54.32||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.||54.32|-26.38|0.7556
71924446|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|4.32|STANDARD_ERROR_OF_MEAN|1.29||0.0015|TWO_SIDED|95.0|1.74|6.91|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.91|1.74|0.0015
71924447|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|1.403||0.5921|TWO_SIDED|95.0|-2.05|3.57|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.57|-2.05|0.5921
71924448|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|1.988||0.9646|TWO_SIDED|95.0|-3.89|4.07|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.07|-3.89|0.9646
71688984|NCT00636636|142893591|SUPERIORITY_OR_OTHER||Difference in proportion|0.102||||0.0268|TWO_SIDED|95.0|0.01|0.19|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in CGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.||0.19|0.01|0.0268
71688985|NCT00636636|142893592|SUPERIORITY_OR_OTHER||Least square mean difference|-0.71|STANDARD_ERROR_OF_MEAN|0.18||0.0001|TWO_SIDED|95.0|-1.07|-0.35|||ANCOVA||P-value versus Placebo for pairwise test of difference of LS mean change from baseline between G-ER and Placebo groups is based on t-test of Type III analysis.|||-0.35|-1.07|0.0001
71688986|NCT00636636|142893593|SUPERIORITY_OR_OTHER||Least square mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.2||0.007|TWO_SIDED|95.0|-0.96|-0.15|||ANCOVA|||||-0.15|-0.96|0.007
71924449|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|4.75||||0.0003|TWO_SIDED|95.0|2.32|7.19|||ANCOVA|||Comparison between Baseline value and Day 29 value.||7.19|2.32|0.0003
71924450|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.326||0.2208|TWO_SIDED|95.0|-1.02|4.3|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.30|-1.02|0.2208
71924451|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|1.927||0.9847|TWO_SIDED|95.0|-3.9|3.83|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.83|-3.90|0.9847
71924452|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|3.53|STANDARD_ERROR_OF_MEAN|1.376||0.0142|TWO_SIDED|95.0|0.75|6.31|||ANCOVA|||Comparison between Baseline value and Day 29 value.||6.31|0.75|0.0142
71924453|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|1.419||0.5547|TWO_SIDED|95.0|-2.02|3.71|||ANCOVA|||Comparison between Baseline value and Day 29 value.||3.71|-2.02|0.5547
71924454|NCT00612456|143369599|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means based on participants with a 'YES' for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|2.287||0.9114|TWO_SIDED|95.0|-4.37|4.88|||ANCOVA|||Comparison between Baseline value and Day 29 value.||4.88|-4.37|0.9114
71688987|NCT01237327|142893594|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7799||||0.3348|TWO_SIDED|95.0|0.47|1.294|||Log Rank|||Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.||1.294|0.47|0.3348
71688988|NCT04811664|142893622|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|52.6|||||TWO_SIDED|95.0|-14.1|80.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||80.3|-14.1|
71688989|NCT04811664|142893625|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|71.0|||||TWO_SIDED|95.0|-9.5|92.3|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||92.3|-9.5|
71688990|NCT04811664|142893626|SUPERIORITY||Vaccine efficacy, (1-HR) *100%|41.2|||||TWO_SIDED|95.0|-37.7|74.9|||||"Immediate Vaccination compared to Standard of care (reference). Wald 95% CI."|Cox model on the calendar time scale, stratified by site and adjusted for sex, residence, team sport participation, mask wearing and SARS-CoV-2 exposure risk score. Outside vaccination censoring.||74.9|-37.7|
71688991|NCT05052697|142893681|OTHER||Geometric Mean Ratio|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A1||2.20|0.34|
71924455|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.383||0.0534|TWO_SIDED|95.0|-0.01|1.53|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.53|-0.01|0.0534
71688992|NCT05052697|142893681|OTHER||Geometric Mean Ratio|1.53|||||TWO_SIDED|95.0|0.86|2.7|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: A2||2.70|0.86|
71924456|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.82|STANDARD_ERROR_OF_MEAN|0.409||0.0508|TWO_SIDED|95.0|0.0|1.64|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.64|-0.00|0.0508
71924457|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.61||||0.3141|TWO_SIDED|95.0|-0.6|1.83|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.||1.83|-0.60|0.3141
71924458|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.395||0.6018|TWO_SIDED|95.0|-1.04|0.62|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||0.62|-1.04|0.6018
71924459|NCT00612456|143369602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.476||0.0509|TWO_SIDED|95.0|0.0|2.0||Statistics has been presented for least square means.|ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||2.00|-0.00|0.0509
71924460|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.566||0.3976|TWO_SIDED|95.0|-0.7|1.68|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.||1.68|-0.70|0.3976
71924461|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.385||0.241|TWO_SIDED|95.0|-0.32|1.23|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.23|-0.32|0.2410
71688993|NCT05052697|142893681|OTHER||Geometric Mean Ratio|0.96|||||TWO_SIDED|95.0|0.4|2.28|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B1||2.28|0.40|
71688994|NCT05052697|142893681|OTHER||Geometric Mean Ratio|0.54|||||TWO_SIDED|95.0|0.25|1.18|||||GMRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the difference (qIRV group minus QIV group) and the corresponding CIs (based on the Student t distribution).|Strain: B2||1.18|0.25|
71688995|NCT05052697|142893682|OTHER||Difference in percentage of participants|26.2|||||TWO_SIDED|95.0|-4.5|53.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A1||53.5|-4.5|
71688996|NCT05052697|142893682|OTHER||Difference in percentage of participants|17.1|||||TWO_SIDED|95.0|-19.2|49.4|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: A2||49.4|-19.2|
71688997|NCT05052697|142893682|OTHER||Difference in percentage of participants|-12.4|||||TWO_SIDED|95.0|-41.7|19.1|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B1||19.1|-41.7|
71688998|NCT05052697|142893682|OTHER||Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-29.2|32.5|||||Difference in percentage of participants achieving seroconversion, qIRV group - Licensed QIV group as reference, expressed as a percentage.|Strain: B2||32.5|-29.2|
71688999|NCT01289574|142893701|SUPERIORITY_OR_OTHER|||||||0.1919|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site||||||0.1919
71689000|NCT01289574|142893702|SUPERIORITY_OR_OTHER|||||||0.061|||||||Cochran-Mantel-Haenszel|||||||0.0610
71689001|NCT01289574|142893703|SUPERIORITY_OR_OTHER|||||||0.0857|||||||Cochran-Mantel-Haenszel|||||||0.0857
71689002|NCT01554163|142893727|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).|Difference in LS Mean Change|-1.63||||0.39|TWO_SIDED|95.0|-5.37|2.1|||ANCOVA|||||2.10|-5.37|0.390
71924462|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|1.27|STANDARD_ERROR_OF_MEAN|0.412||0.0032|TWO_SIDED|95.0|0.44|2.09|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||2.09|0.44|0.0032
71924463|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.58|STANDARD_ERROR_OF_MEAN|0.581||0.3185|TWO_SIDED|95.0|-0.58|1.75|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size||1.75|-0.58|0.3185
71924464|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.377||0.1074|TWO_SIDED|95.0|-0.14|1.37|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.37|-0.14|0.1074
71924465|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.402||0.0403|TWO_SIDED|95.0|0.04|1.65|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.65|0.04|0.0403
71924466|NCT00612456|143369602|SUPERIORITY_OR_OTHER|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.594||0.249|TWO_SIDED|95.0|-0.5|1.88|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size||1.88|-0.50|0.2490
71924467|NCT01258803|143369606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.124|||<|0.001|TWO_SIDED|95.0|0.094|0.154|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.154|0.094|<0.001
71924468|NCT01258803|143369607|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.102|||<|0.001|TWO_SIDED|95.0|0.073|0.131|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.131|0.073|<0.001
71924469|NCT01258803|143369608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.022||||0.144|TWO_SIDED|95.0|-0.008|0.052|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.052|-0.008|0.144
71924470|NCT01258803|143369610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.018||||0.229|TWO_SIDED|95.0|-0.012|0.048|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.048|-0.012|0.229
71924471|NCT01258803|143369611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.004||||0.79|TWO_SIDED|95.0|-0.033|0.025|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.025|-0.033|0.790
71924472|NCT01258803|143369612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.106|||<|0.001|TWO_SIDED|95.0|0.077|0.135|||ANCOVA|||"Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."||0.135|0.077|<0.001
71924473|NCT00920582|143369614|SUPERIORITY||Odds Ratio (OR)|1.348||||0.609|TWO_SIDED|95.0|0.431|4.219|||Mantel Haenszel|||||4.219|0.431|0.609
71924474|NCT00920582|143369614|SUPERIORITY||Odds Ratio (OR)|1.356||||0.601|TWO_SIDED|95.0|0.453|4.23|||Mantel Haenszel|||||4.230|0.453|0.601
71924475|NCT00920582|143369614|SUPERIORITY||Odds Ratio (OR)|1.624||||0.4|TWO_SIDED|95.0|0.521|5.066|||Mantel Haenszel|||||5.066|0.521|0.400
71924476|NCT00920582|143369616|SUPERIORITY||Mean Difference (Final Values)|-0.028||||0.365|TWO_SIDED|95.0|-0.086|0.031|||ANCOVA|||||0.031|-0.086|0.365
71924477|NCT00920582|143369616|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.842|TWO_SIDED|95.0|-0.078|0.064|||ANCOVA|||||0.064|-0.078|0.842
71924478|NCT00920582|143369616|SUPERIORITY||Mean Difference (Final Values)|0.021||||0.565|TWO_SIDED|95.0|-0.089|0.171|||ANCOVA|||||0.171|-0.089|0.565
71924479|NCT00920582|143369621|SUPERIORITY||Odds Ratio (OR)|2.197||||0.142|TWO_SIDED|95.0|0.764|6.312|||Mantel Haenszel|||||6.312|0.764|0.142
71924480|NCT00920582|143369621|SUPERIORITY||Odds Ratio (OR)|1.487||||0.46|TWO_SIDED|95.0|0.517|4.278|||Mantel Haenszel|||||4.278|0.517|0.460
71924481|NCT00920582|143369621|SUPERIORITY||Odds Ratio (OR)|1.954||||0.199|TWO_SIDED|95.0|0.69|5.532|||Mantel Haenszel|||||5.532|0.690|0.199
71924482|NCT04652245|143369632|SUPERIORITY|||||||0.028|||||||ANCOVA|||||||0.028
71924483|NCT04652245|143369633|SUPERIORITY|||||||0.008|||||||ANCOVA|||||||0.008
71924484|NCT04419558|143369637|OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.077||0.6579|TWO_SIDED|95.0|-0.12|0.19|||Mixed Models Analysis|||||0.19|-0.12|0.6579
71924485|NCT05146999|143369649|SUPERIORITY||Treatment difference|83.8|||<|0.001|TWO_SIDED|95.0|72.81|94.87|||Cochran-Mantel-Haenszel|||||94.87|72.81|<0.001
71924486|NCT00796367|143369690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71|STANDARD_ERROR_OF_MEAN|0.673|<|0.0001|TWO_SIDED|95.0|7.39|10.03||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||10.03|7.39|<0.0001
71924487|NCT00796367|143369690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.52|STANDARD_ERROR_OF_MEAN|0.799|<|0.0001|TWO_SIDED|95.0|5.95|9.09||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||9.09|5.95|<0.0001
71924488|NCT00796367|143369690|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19|STANDARD_ERROR_OF_MEAN|0.76||0.1189|TWO_SIDED|95.0|-0.31|2.68||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.68|-0.31|0.1189
71924489|NCT00796367|143369691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.4|STANDARD_ERROR_OF_MEAN|1.97|<|0.0001|TWO_SIDED|95.0|6.24|14.16||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||14.16|6.24|<0.0001
71924490|NCT00796367|143369691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|4.36|11.19||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||11.19|4.36|<0.0001
71924491|NCT00796367|143369691|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|STANDARD_ERROR_OF_MEAN|0.32||0.2169|TWO_SIDED|95.0|0.84|2.15|||Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)||2.15|0.84|0.2169
71924492|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.2|||<|0.0001|TWO_SIDED|95.0|15.9|37.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.0|15.9|<.0001
71924493|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|25.3|||<|0.0001|TWO_SIDED|95.0|17.1|37.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.3|17.1|<.0001
71924494|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.4|||<|0.0001|TWO_SIDED|95.0|14.9|33.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.7|14.9|<.0001
71924495|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.5|||<|0.0001|TWO_SIDED|95.0|10.8|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|10.8|<.0001
71924496|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|147.0||||0.1148|TWO_SIDED|95.0|93.7|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|93.7|0.1148
71924497|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|153.0||||0.044|TWO_SIDED|95.0|101.0|233.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||233|101|0.0440
71924498|NCT05664672|143369692|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|136.0||||0.2422|TWO_SIDED|95.0|87.8|210.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||210|87.8|0.2422
71924499|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.9||||0.0994|TWO_SIDED|95.0|22.7|110.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||110|22.7|0.0994
71924500|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|65.8||||0.4162|TWO_SIDED|95.0|32.0|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|32.0|0.4162
71924501|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|47.5|215.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||215|47.5|1.0000
71924502|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2.23|||<|0.0001|TWO_SIDED|95.0|1.01|4.94|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||4.94|1.01|<.0001
71924503|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2230.0|||<|0.0001|TWO_SIDED|95.0|965.0|5160.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||5160|965|<.0001
71689003|NCT01554163|142893728|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.32||||0.464|TWO_SIDED|95.0|-4.88|2.23|||ANCOVA|||||2.23|-4.88|0.464
71924504|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|2940.0|||<|0.0001|TWO_SIDED|95.0|1350.0|6400.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||6400|1350|<.0001
71924505|NCT05664672|143369693|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4530.0|||<|0.0001|TWO_SIDED|95.0|2020.0|10200.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10200|2020|<.0001
71924506|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.69|||<|0.0001|TWO_SIDED|95.0|3.29|9.87|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||9.87|3.29|<.0001
71924507|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|8.08|||<|0.0001|TWO_SIDED|95.0|4.88|13.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||13.4|4.88|<.0001
71924508|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.58|||<|0.0001|TWO_SIDED|95.0|3.88|11.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||11.2|3.88|<.0001
71924509|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.03|||<|0.0001|TWO_SIDED|95.0|3.46|10.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||10.5|3.46|<.0001
71924510|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.4||||0.9972|TWO_SIDED|95.0|52.7|169.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||169|52.7|0.9972
71924511|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|134.0||||0.4655|TWO_SIDED|95.0|77.9|230.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||230|77.9|0.4655
71924512|NCT05664672|143369694|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|109.0||||0.9851|TWO_SIDED|95.0|62.1|192.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||192|62.1|0.9851
71924513|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.7|||<|0.0001|TWO_SIDED|95.0|9.72|19.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.2|9.72|<.0001
71924514|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.6|||<|0.0001|TWO_SIDED|95.0|12.1|22.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.6|12.1|<.0001
71924515|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.4|||<|0.0001|TWO_SIDED|95.0|9.68|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.68|<.0001
71924516|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.7|||<|0.0001|TWO_SIDED|95.0|11.2|22.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.2|11.2|<.0001
71689004|NCT01554163|142893729|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.09||||0.624|TWO_SIDED|95.0|-5.48|3.3|||ANCOVA|||||3.30|-5.48|0.624
71689005|NCT01554163|142893730|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.08||||0.369|TWO_SIDED|95.0|-0.26|0.1|||ANCOVA|||||0.10|-0.26|0.369
71924517|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.8||||0.7167|TWO_SIDED|95.0|60.6|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|60.6|0.7167
71924518|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|105.0||||0.9864|TWO_SIDED|95.0|75.3|147.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||147|75.3|0.9864
71924519|NCT05664672|143369695|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|85.1||||0.5911|TWO_SIDED|95.0|60.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|60.1|0.5911
71924520|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|29.6|||<|0.0001|TWO_SIDED|95.0|21.8|40.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.0|21.8|<.0001
71924521|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.3|||<|0.0001|TWO_SIDED|95.0|21.5|37.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||37.4|21.5|<.0001
71924522|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|33.1|||<|0.0001|TWO_SIDED|95.0|24.8|44.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||44.2|24.8|<.0001
71924523|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.5|||<|0.0001|TWO_SIDED|95.0|27.7|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|27.7|<.0001
71924524|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|78.8||||0.195|TWO_SIDED|95.0|57.3|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|57.3|0.1950
71924525|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|75.5||||0.0699|TWO_SIDED|95.0|56.1|102.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||102|56.1|0.0699
71924526|NCT05664672|143369696|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.3||||0.7041|TWO_SIDED|95.0|64.7|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|64.7|0.7041
71689006|NCT01554163|142893731|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.09||||0.294|TWO_SIDED|95.0|-0.25|0.08|||ANCOVA|||||0.08|-0.25|0.294
71689007|NCT01554163|142893732|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.86||||0.679|TWO_SIDED|95.0|-4.96|3.24|||ANCOVA|||||3.24|-4.96|0.679
71689008|NCT01554163|142893733|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean Change|-0.1||||0.314|TWO_SIDED|95.0|-0.3|0.1|||ANCOVA|||||0.10|-0.30|0.314
71689009|NCT01037816|142893740|SUPERIORITY|||||||0.137|||||||ANCOVA|||The treatment effect of the FS-67 patch was estimated by computing the difference in LS means of the FS-67 and placebo patches from the ANCOVA model||||0.137
71689010|NCT01037816|142893741|SUPERIORITY|||||||0.044|||||||ANCOVA|||||||0.044
71689011|NCT01972464|142893746|SUPERIORITY||Odds Ratio (OR)|1.77||||0.39|TWO_SIDED|95.0|0.48|6.52||a priori threshold for statistical significance = 0.05|Regression, Logistic|adjusted for age (18-25 years versus \>25 years) and pre-quit smoking level (\<10 versus \>10 cigarettes per day)|OR represents of odds of abstinence in progesterone group versus placebo group|Null hypothesis- odds of week 8 point prevalence abstinence were equal between placebo and progesterone group.||6.52|0.48|0.39
71924527|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.57|18.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.4|9.57|<.0001
71924528|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.3|||<|0.0001|TWO_SIDED|95.0|9.84|17.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||17.9|9.84|<.0001
71924529|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.6|||<|0.0001|TWO_SIDED|95.0|9.93|18.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||18.6|9.93|<.0001
71924530|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|9.28|||<|0.0001|TWO_SIDED|95.0|6.67|12.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.9|6.67|<.0001
71924531|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0404|TWO_SIDED|95.0|101.0|202.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||202|101|0.0404
71924532|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|143.0||||0.0243|TWO_SIDED|95.0|104.0|198.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||198|104|0.0243
71924533|NCT05664672|143369697|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|146.0||||0.0215|TWO_SIDED|95.0|105.0|205.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||205|105|0.0215
71924534|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.37|||<|0.0001|TWO_SIDED|95.0|3.69|7.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.80|3.69|<.0001
71924535|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.65|||<|0.0001|TWO_SIDED|95.0|4.01|7.96|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.96|4.01|<.0001
71924536|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|5.61|||<|0.0001|TWO_SIDED|95.0|3.92|8.03|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.03|3.92|<.0001
71924537|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.09|||<|0.0001|TWO_SIDED|95.0|4.17|8.89|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.89|4.17|<.0001
71924538|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.1||||0.8335|TWO_SIDED|95.0|59.4|131.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||131|59.4|0.8335
71924539|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.9||||0.9622|TWO_SIDED|95.0|64.2|134.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||134|64.2|0.9622
71924540|NCT05664672|143369698|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|92.1||||0.9531|TWO_SIDED|95.0|62.8|135.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||135|62.8|0.9531
71924541|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.4|22.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.3|14.4|<.0001
71924542|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.0|||<|0.0001|TWO_SIDED|95.0|14.8|22.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.1|14.8|<.0001
71924543|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|15.8|||<|0.0001|TWO_SIDED|95.0|12.8|19.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||19.4|12.8|<.0001
71924544|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.6|22.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||22.7|14.6|<.0001
71924545|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.4||||0.9993|TWO_SIDED|95.0|78.2|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|78.2|0.9993
71924546|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.9||||0.9998|TWO_SIDED|95.0|79.7|123.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||123|79.7|0.9998
71924547|NCT05664672|143369699|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.4||||0.3019|TWO_SIDED|95.0|69.1|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|69.1|0.3019
71689012|NCT01972464|142893747|SUPERIORITY||Hazard Ratio (HR)|1.39||||0.41|TWO_SIDED|95.0|0.66|3.38||a priori threshold = 0.05|Regression, Cox|Adjusted for age and pre-quit smoking level|Hazard ratio is placebo / progesterone|||3.38|0.66|0.41
71924548|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.3|||<|0.0001|TWO_SIDED|95.0|13.2|25.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.3|13.2|<.0001
71924549|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.7|||<|0.0001|TWO_SIDED|95.0|17.6|31.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||31.9|17.6|<.0001
71924550|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|19.3|||<|0.0001|TWO_SIDED|95.0|14.2|26.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||26.4|14.2|<.0001
71924551|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.0|||<|0.0001|TWO_SIDED|95.0|17.3|33.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||33.3|17.3|<.0001
71924552|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|76.1||||0.153|TWO_SIDED|95.0|54.0|107.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||107|54.0|0.1530
71924553|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.6||||0.9999|TWO_SIDED|95.0|71.7|136.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||136|71.7|0.9999
71924554|NCT05664672|143369700|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|80.5||||0.3025|TWO_SIDED|95.0|57.8|112.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||112|57.8|0.3025
71924555|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.7|||<|0.0001|TWO_SIDED|95.0|17.0|30.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||30.4|17.0|<.0001
71924556|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|21.6|36.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.6|21.6|<.0001
71924557|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|27.5|||<|0.0001|TWO_SIDED|95.0|20.8|36.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||36.2|20.8|<.0001
71924558|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.7|||<|0.0001|TWO_SIDED|95.0|21.4|38.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||38.4|21.4|<.0001
71924559|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|79.4||||0.1843|TWO_SIDED|95.0|58.6|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|58.6|0.1843
71924560|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|98.1||||0.9994|TWO_SIDED|95.0|73.9|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|73.9|0.9994
71689013|NCT01972464|142893748|SUPERIORITY||Risk Ratio (RR)|0.91|||<|0.001|TWO_SIDED|95.0|0.86|0.96|||general estimating equation|adjusted for age \& pre-quit smoking level; specified a gamma distribution, log link, autoregressive correlation structure|risk ratio is progesterone versus placebo|null hypothesis rate of change in QSU-brief scores were equal between treatment groups||0.96|0.86|<0.001
71924561|NCT05664672|143369701|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|95.9||||0.9891|TWO_SIDED|95.0|71.4|129.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||129|71.4|0.9891
71924562|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|37.3|||<|0.0001|TWO_SIDED|95.0|30.4|45.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.7|30.4|<.0001
71924563|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|44.0|||<|0.0001|TWO_SIDED|95.0|36.5|53.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.1|36.5|<.0001
71924564|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|41.8|||<|0.0001|TWO_SIDED|95.0|34.4|50.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||50.9|34.4|<.0001
71924565|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|42.9|||<|0.0001|TWO_SIDED|95.0|34.9|52.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.7|34.9|<.0001
71924566|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.9||||0.3027|TWO_SIDED|95.0|70.0|108.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||108|70.0|0.3027
71924567|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9926|TWO_SIDED|95.0|83.9|125.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||125|83.9|0.9926
71924568|NCT05664672|143369702|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|97.5||||0.9938|TWO_SIDED|95.0|79.1|120.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||120|79.1|0.9938
71924569|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|46.3|||<|0.0001|TWO_SIDED|95.0|39.5|54.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.4|39.5|<.0001
71924570|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|55.6|||<|0.0001|TWO_SIDED|95.0|48.0|64.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.4|48.0|<.0001
71689014|NCT01133704|142893750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.719|TWO_SIDED|95.0|0.69|1.7|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)|||1.70|0.69|0.719
71689015|NCT01133704|142893751|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.27||||0.331|TWO_SIDED|95.0|0.78|2.07|||Log Rank||Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).|||2.07|0.78|0.331
71689016|NCT00136214|142893752|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.08
71689017|NCT00136214|142893752|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Mi/Cr at time points 1,2 and 3||||0.3
71689018|NCT00136214|142893752|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.9
71689019|NCT00136214|142893752|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.7
71924571|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.7|||<|0.0001|TWO_SIDED|95.0|45.2|61.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||61.5|45.2|<.0001
71924572|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|54.9|||<|0.0001|TWO_SIDED|95.0|46.7|64.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||64.5|46.7|<.0001
71924573|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|84.4||||0.0504|TWO_SIDED|95.0|71.2|100.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||100|71.2|0.0504
71924574|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||0.9988|TWO_SIDED|95.0|86.4|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|86.4|0.9988
71924575|NCT05664672|143369703|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|96.0||||0.9238|TWO_SIDED|95.0|81.4|113.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||113|81.4|0.9238
71924576|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|3.71|||<|0.0001|TWO_SIDED|95.0|1.88|7.31|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.31|1.88|<.0001
71924577|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.25|||<|0.0001|TWO_SIDED|95.0|2.28|7.93|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||7.93|2.28|<.0001
71689020|NCT00136214|142893752|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1,2 and 3||||0.4
71689021|NCT00136214|142893752|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.6
71689022|NCT00136214|142893752|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3||||0.3
71689023|NCT00136214|142893752|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy ofMI/Cr at time points 1,2 and 3||||0.3
71689024|NCT00136214|142893752|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3||||0.3
71689025|NCT00136214|142893752|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.4
71689026|NCT00136214|142893752|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.9
71689027|NCT00136214|142893752|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
71689028|NCT00136214|142893752|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.7
71689029|NCT00136214|142893752|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.1
71924578|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|4.24|||<|0.0001|TWO_SIDED|95.0|2.2|8.14|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||8.14|2.20|<.0001
71924579|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|6.4|||<|0.0001|TWO_SIDED|95.0|3.22|12.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||12.7|3.22|<.0001
71924580|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|57.9||||0.184|TWO_SIDED|95.0|28.3|119.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||119|28.3|0.1840
71924581|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.4||||0.3552|TWO_SIDED|95.0|34.0|130.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||130|34.0|0.3552
71924582|NCT05664672|143369704|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|66.2||||0.381|TWO_SIDED|95.0|33.0|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|33.0|0.3810
71924583|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|16.8|||<|0.0001|TWO_SIDED|95.0|13.0|21.8|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||21.8|13.0|<.0001
71924584|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|20.5|||<|0.0001|TWO_SIDED|95.0|16.2|25.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||25.9|16.2|<.0001
71924585|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|18.2|||<|0.0001|TWO_SIDED|95.0|14.3|23.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.4|14.3|<.0001
71924586|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|17.8|||<|0.0001|TWO_SIDED|95.0|13.7|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||23.1|13.7|<.0001
71924587|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|94.5||||0.9589|TWO_SIDED|95.0|72.0|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|72.0|0.9589
71924588|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|115.0||||0.4442|TWO_SIDED|95.0|89.3|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|89.3|0.4442
71924589|NCT05664672|143369705|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|103.0||||0.9975|TWO_SIDED|95.0|78.8|133.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||133|78.8|0.9975
71924590|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|36.5|||<|0.0001|TWO_SIDED|95.0|23.9|55.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||55.6|23.9|<.0001
71924591|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|39.9|||<|0.0001|TWO_SIDED|95.0|27.1|59.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.0|27.1|<.0001
71924592|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|30.2|||<|0.0001|TWO_SIDED|95.0|20.1|45.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||45.5|20.1|<.0001
71924593|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|48.9||||0.0002|TWO_SIDED|95.0|31.9|75.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||75.0|31.9|0.0002
71924594|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|74.5||||0.2938|TWO_SIDED|95.0|47.6|117.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||117|47.6|0.2938
71924595|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|81.6||||0.5552|TWO_SIDED|95.0|53.7|124.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||124|53.7|0.5552
71924596|NCT05664672|143369706|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|61.7||||0.0254|TWO_SIDED|95.0|39.9|95.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||95.5|39.9|0.0254
71924597|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|52.1|||<|0.0001|TWO_SIDED|95.0|40.4|67.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||67.1|40.4|<.0001
71924598|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|49.3|||<|0.0001|TWO_SIDED|95.0|39.0|62.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||62.2|39.0|<.0001
71924599|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|40.8|||<|0.0001|TWO_SIDED|95.0|32.0|52.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||52.1|32.0|<.0001
71924600|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|45.9|||<|0.0001|TWO_SIDED|95.0|35.7|59.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||59.2|35.7|<.0001
71924601|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.5817|TWO_SIDED|95.0|86.8|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|86.8|0.5817
71924602|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.8852|TWO_SIDED|95.0|83.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||138|83.7|0.8852
71924603|NCT05664672|143369707|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|88.9||||0.607|TWO_SIDED|95.0|68.7|115.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||115|68.7|0.6070
71924604|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|13.2|||<|0.0001|TWO_SIDED|95.0|5.44|32.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||32.0|5.44|<.0001
71924605|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|23.8|||<|0.0001|TWO_SIDED|95.0|10.7|53.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.3|10.7|<.0001
71924606|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.7||||0.0003|TWO_SIDED|95.0|10.6|57.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||57.4|10.6|0.0003
71924607|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|22.3||||0.0002|TWO_SIDED|95.0|9.21|54.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||54.1|9.21|0.0002
71924608|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|59.1||||0.428|TWO_SIDED|95.0|23.3|150.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||150|23.3|0.4280
71924609|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|107.0||||0.999|TWO_SIDED|95.0|44.8|255.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||255|44.8|0.9990
71924610|NCT05664672|143369708|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|110.0||||0.9958|TWO_SIDED|95.0|44.9|272.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||272|44.9|0.9958
71924611|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|-50.8|||<|0.0001|TWO_SIDED|95.0|-77.7|-23.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-23.9|-77.7|<.0001
71924612|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|-45.0|||<|0.0001|TWO_SIDED|95.0|-69.6|-20.3|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-20.3|-69.6|<.0001
71689030|NCT00136214|142893752|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2||||0.6
71924613|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|-42.3||||0.0003|TWO_SIDED|95.0|-68.2|-16.5|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-16.5|-68.2|0.0003
71924614|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|-44.8||||0.0004|TWO_SIDED|95.0|-72.6|-17.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||-17.0|-72.6|0.0004
71689031|NCT00136214|142893752|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2||||0.5
71689032|NCT00136214|142893752|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2||||0.4
71689033|NCT00136214|142893752|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Crat time points 1 and 2||||0.9
71689034|NCT00136214|142893753|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for HVLT||||>0.05
71689035|NCT00136214|142893753|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for ROCF||||< 0.05
71689036|NCT00136214|142893753|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for HVLT||||>0.05
71924615|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|-6.05||||0.9551|TWO_SIDED|95.0|-35.2|23.1|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||23.1|-35.2|0.9551
71924616|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|-0.198||||1|TWO_SIDED|95.0|-27.3|26.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||26.9|-27.3|1.0000
71924617|NCT05664672|143369709|SUPERIORITY||Ratio of geometric LS means|2.48||||0.9981|TWO_SIDED|95.0|-25.6|30.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||30.6|-25.6|0.9981
71689037|NCT00136214|142893753|SUPERIORITY||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for ROCF||||>0.05
71689038|NCT04985942|142893754|SUPERIORITY||Least Squares Mean Difference|-4.9|STANDARD_ERROR_OF_MEAN|0.75|<|0.0001|TWO_SIDED|95.0|-6.38|-3.44|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-3.44|-6.38|<0.0001
71689039|NCT04985942|142893755|SUPERIORITY||Least Squares Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.85|-0.48|||Mixed Effects Model for Repeated Measure|MMRM Analysis Based on Hypothetical Estimand Strategy||||-0.48|-0.85|<0.0001
71924618|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|31.7|||<|0.0001|TWO_SIDED|95.0|18.7|53.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||53.9|18.7|<.0001
71924619|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.5|||<|0.0001|TWO_SIDED|95.0|17.6|46.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||46.2|17.6|<.0001
71689040|NCT02849704|142893757|SUPERIORITY||||||<|0.001||||||a priori threshold for significance: \<0.05|t-test, 2 sided|||||||<0.001
71689041|NCT02849704|142893758|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
71689042|NCT02849704|142893759|SUPERIORITY||||||<|0.01||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.01
71689043|NCT02849704|142893760|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
71689044|NCT02849704|142893761|SUPERIORITY||||||<|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||<0.05
71689045|NCT02849704|142893762|SUPERIORITY||||||>|0.05||||||a priori threshold for statistical significance \<0.05|t-test, 2 sided|||||||>0.05
71689046|NCT01128400|142893769|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71689047|NCT01128400|142893770|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANOVA|||||||0.05
71689048|NCT04304508|142893780|OTHER|Dose-response test by using multiple comparison procedures (MCP) Mod.||||||0.7976|||||||MCP Mod|||Dose-response test||||0.7976
71689049|NCT04304508|142893780|OTHER||Crude incidence ratio|1.044|||||TWO_SIDED|90.0|0.8105|1.3478||||||Comparison of the Asundexian 10 mg group versus Placebo group.||1.3478|0.8105|
71689050|NCT04304508|142893780|OTHER||Crude incidence ratio|1.1963|||||TWO_SIDED|90.0|0.9281|1.5428||||||Comparison of the Asundexian 20 mg group versus Placebo group.||1.5428|0.9281|
71689051|NCT04304508|142893780|OTHER||Crude incidence ratio|1.0485|||||TWO_SIDED|90.0|0.8082|1.3619||||||Comparison of the Asundexian 50 mg group versus Placebo group.||1.3619|0.8082|
71689052|NCT04304508|142893788|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.724|||=|0.1507|TWO_SIDED|90.0|0.924|3.215|||Log Rank|||Comparison of the Asundexian 10 mg group versus Placebo group||3.215|0.924|= 0.1507
71689053|NCT04304508|142893788|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.285|||=|0.5339|TWO_SIDED|90.0|0.662|2.494|||Log Rank|||Comparison of the Asundexian 20 mg group versus Placebo group||2.494|0.662|= 0.5339
71689054|NCT04304508|142893788|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.749|||=|0.1401|TWO_SIDED|90.0|0.938|3.262|||Log Rank|||Comparison of the Asundexian 50 mg group versus Placebo group||3.262|0.938|= 0.1401
71924620|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|24.3|||<|0.0001|TWO_SIDED|95.0|14.7|40.2|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||40.2|14.7|<.0001
71689055|NCT04304508|142893788|OTHER|Cause specific HRs were only calculated if at least 3 events occurred in 1 of the compared groups and at least 1 event in each of the compared treatment groups.|Cox Proportional Hazard|1.585|||=|0.1653|TWO_SIDED|90.0|0.918|2.736|||Log Rank|||Comparison of the Total Asundexian group versus Placebo group||2.736|0.918|= 0.1653
71924621|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|28.1|||<|0.0001|TWO_SIDED|95.0|16.6|47.7|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||47.7|16.6|<.0001
71924622|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|113.0||||0.9511|TWO_SIDED|95.0|64.7|197.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||197|64.7|0.9511
71924623|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|101.0||||1|TWO_SIDED|95.0|60.4|170.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||170|60.4|1.0000
71924624|NCT05664672|143369710|SUPERIORITY||Ratio of geometric LS means (Test/Ref)|86.5||||0.9003|TWO_SIDED|95.0|50.6|148.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric LSM calculated by transforming the natural-log LS means back to the linear scale. Ratio of geometric LSM expressed as percentage. In statistical model, group \& gender included as fixed effects; baseline value included as covariate.|||148|50.6|0.9003
71924625|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|46.4|||<|0.0001|TWO_SIDED|95.0|37.1|58.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||58.0|37.1|<.0001
71924626|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|43.1|||<|0.0001|TWO_SIDED|95.0|35.1|52.9|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||52.9|35.1|<.0001
71924627|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|44.1|||<|0.0001|TWO_SIDED|95.0|35.5|54.6|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||54.6|35.5|<.0001
71924628|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|39.1|||<|0.0001|TWO_SIDED|95.0|31.0|49.4|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||49.4|31.0|<.0001
71924629|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|119.0||||0.2351|TWO_SIDED|95.0|93.2|151.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||151|93.2|0.2351
71924630|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|110.0||||0.657|TWO_SIDED|95.0|87.7|138.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||138|87.7|0.6570
71924631|NCT05664672|143369711|SUPERIORITY||Ratio of geometric LS means|113.0||||0.5112|TWO_SIDED|95.0|89.1|142.0|||ANCOVA|Least square means (LSM) calculated from mixed model to control for variables were used for analysis instead of the observed means reported on table.|Geometric least squares means were calculated by transforming the natural-log LS means back to the linear scale. Est. para. is ratio of geometric LS means for natural-log (expressed as a percentage), natural-log transformed back to the linear scale.|||142|89.1|0.5112
71924632|NCT01598831|143369722|SUPERIORITY||Risk Difference (RD)|-2.55||||0.318|TWO_SIDED|95.0|-3.68|8.77||The threshold for statistical significance was a two sided 5%|Cochran-Mantel-Haenszel|CMH test controlled for the stratification factor.|Rates by Arm are 26.8% for ART-123 and 29.4% for Placebo||In a post hoc sensitivity analysis for the primary outcome that accounted for pooled site as a random effect, the adjusted 28-day all-cause mortality rate was 24.8%in the rhsTM group vs 27.5%in the placebo group (P = .31).|8.77|-3.68|0.318
71924633|NCT02260791|143369794|EQUIVALENCE|-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate|Mean Difference (Final Values)|-1.8|||||TWO_SIDED|90.0|-7.3|3.6||||||The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.||3.6|-7.3|
71924634|NCT02260791|143369795|EQUIVALENCE|If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between -0.6 and +0.6 then FKB327 was considered equivalent to Humira.|Difference in least square mean|0.01|||||TWO_SIDED|95.0|-0.16|0.18||||||The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.||0.18|-0.16|
71924635|NCT02985541|143369815|OTHER||3-year probability of getting pregnant|0.68|||||TWO_SIDED|95.0|0.17|2.71||||||Cumulative failure rate (Kaplan-Meier) during Years 6-8||2.71|0.17|
71924636|NCT04140942|143369830|SUPERIORITY|||||||0.15|||||||Chi-squared|||6-Month Employment||||.15
71924637|NCT04140942|143369830|SUPERIORITY|||||||0.001|||||||Regression, Logistic|||6-Month Employment||||.001
71924638|NCT04140942|143369830|SUPERIORITY|||||||0.87|||||||Chi-squared|||12-Month Employment||||.87
71924639|NCT04140942|143369831|SUPERIORITY|||||||0.04|||||||ANCOVA|Repeated measures.||||||0.04
71924640|NCT04140942|143369832|SUPERIORITY|||||||0.056|||||||Chi-squared|||12-Month Recidivism Analysis||||.056
71924641|NCT04140942|143369832|SUPERIORITY|||||||0.18|||||||Chi-squared|||6-Month Recidivism Analysis||||.18
71924642|NCT00933543|143369861|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.43||||0.0703|TWO_SIDED|95.0|0.65|63.18||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||63.18|0.65|0.0703
71924643|NCT00933543|143369863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.92||||0.2969|TWO_SIDED|95.0|-11.35|3.5||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||3.50|-11.35|0.2969
71924644|NCT00933543|143369864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.67||||0.8913|TWO_SIDED|95.0|-9.09|10.43||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)||10.43|-9.09|0.8913
71924645|NCT04988035|143369887|SUPERIORITY||Odds Ratio (OR)|0.64||||0.09|TWO_SIDED|95.0|0.38|1.07|||Proportional odds model||Odds ratio greater than 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. Odds ratio of a better clinical status score, confidence interval and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using multiple imputation (MI) for participants lost to follow-up before Day 8 while hospitalized, in hospice, long term acute care, or transferred to other hospital while those participants lost to follow-up after discharge to home are assigned a score of 2.||1.07|0.38|0.090
71924646|NCT04988035|143369888|SUPERIORITY||Odds Ratio (OR)|0.69||||0.358|TWO_SIDED|95.0|0.31|1.53|||Regression, Logistic|||Odds ratio, confidence interval, and p-value estimated from a logistic regression model adjusted for baseline dexamethasone use, baseline ordinal score, age, and baseline C-Reactive Protein (CRP).|Odds ratio greater than 1 favors Remdesivir plus Danicopan|1.53|0.31|0.358
71924647|NCT04988035|143369889|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.014|TWO_SIDED|95.0|0.46|0.92|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|Hazard ratio, confidence interval, and p-value estimated from a Cox model adjusted for baseline steroid use and baseline ordinal score.||0.92|0.46|0.014
71924648|NCT04988035|143369890|SUPERIORITY||Odds Ratio (OR)|0.7||||0.177|TWO_SIDED|95.0|0.42|1.17|||Proportional odds model||Odds ratio above 1 favors Remdesivir plus Danicopan.|Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 15 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 15 after discharge are given a score of 2.||1.17|0.42|0.177
71924649|NCT04988035|143369891|SUPERIORITY||Odds Ratio (OR)|0.81||||0.427|TWO_SIDED|95.0|0.48|1.36|||Proportional odds model|||Includes all ordinal score categories. OR of a better clinical status score, confidence interval, and p-value estimated from a proportional odds model adjusted for baseline steroid use and baseline ordinal score. Missing data imputed using last observation carried forward for participants lost to follow-up before Day 29 while hospitalized, in hospice, long term acute care, or transferred to other hospital. Participants lost to follow-up before Day 29 after discharge are given a score of 2.|Odds ratio above 1 favors Remdesivir plus Danicopan.|1.36|0.48|0.427
71924650|NCT04988035|143369926|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.109|TWO_SIDED|95.0|0.56|1.06|||Regression, Cox||HR greater than 1 favors Remdesivir plus Danicopan.|||1.06|0.56|0.109
71924651|NCT04988035|143369927|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.036|TWO_SIDED|95.0|0.51|0.98|||Regression, Cox||||HR greater than 1 favors Remdesivir plus Danicopan.|0.98|0.51|0.036
71924652|NCT03602976|143369929|SUPERIORITY||Mean Difference (Final Values)|190.7||||0.059|TWO_SIDED||||||t-test, 2 sided|||For GGT||||0.059
71924653|NCT03602976|143369929|SUPERIORITY||Mean Difference (Final Values)|55.5||||0.23|TWO_SIDED||||||t-test, 2 sided|||For Alkaline Phosphatase||||0.23
71924654|NCT03602976|143369930|SUPERIORITY||Mean Difference (Final Values)|2.06||||0.36|TWO_SIDED||||||t-test, 2 sided|||||||0.36
71924655|NCT03602976|143369931|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.73|TWO_SIDED||||||t-test, 2 sided|||||||0.73
71924656|NCT03602976|143369932|SUPERIORITY||Mean Difference (Final Values)|12.2||||0.094|TWO_SIDED||||||t-test, 2 sided|||||||0.094
71924657|NCT03602976|143369933|SUPERIORITY||Mean Difference (Final Values)|21.0||||0.11|TWO_SIDED||||||t-test, 2 sided|||||||0.11
71924658|NCT04837807|143369934|SUPERIORITY||Mean Difference (Final Values)|22.4|STANDARD_DEVIATION|12.8|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||"Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as better scores thus representing more comfort than previous weeks."||||<0.05
71924659|NCT04837807|143369936|SUPERIORITY|OSDI scores were obtained across all three visits, baseline, week 1 and week 2. Lower OSDI scores indicate better eye health.|Mean Difference (Final Values)|10.5|STANDARD_DEVIATION|7.3|<|0.05|TWO_SIDED||||||ANOVA|This was a cross-over study, so there is really 30 subjects per group that was analyzed.||||||<0.05
71924660|NCT04278846|143369971|SUPERIORITY|||||||0.87|||||||Kruskal-Wallis|||||||.87
71924661|NCT04278846|143369972|SUPERIORITY|||||||0.49|||||||Kruskal-Wallis|||||||.49
71924662|NCT04278846|143369973|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||.57
71924663|NCT04278846|143369974|SUPERIORITY|||||||0.3|||||||Kruskal-Wallis|||||||.3
71924664|NCT04278846|143369975|SUPERIORITY|||||||0.99|||||||Kruskal-Wallis|||||||.99
71924665|NCT04278846|143369976|SUPERIORITY|||||||0.33|||||||Kruskal-Wallis|||||||.33
71924666|NCT04278846|143369977|SUPERIORITY|||||||0.26|||||||Kruskal-Wallis|||||||.26
71924667|NCT04278846|143369978|SUPERIORITY|||||||0.79|||||||Kruskal-Wallis|||||||.79
71924668|NCT04278846|143369979|SUPERIORITY|||||||0.62|||||||Kruskal-Wallis|||||||.62
71924669|NCT04278846|143369980|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||.94
71924670|NCT04278846|143369981|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
71924671|NCT04278846|143369982|SUPERIORITY|||||||0.54|||||||Kruskal-Wallis|||||||.54
71924672|NCT04278846|143369983|SUPERIORITY|||||||0.95|||||||Kruskal-Wallis|||||||.95
71924673|NCT04278846|143369984|SUPERIORITY|||||||0.96|||||||Kruskal-Wallis|||||||.96
71924674|NCT04278846|143369986|SUPERIORITY|||||||0.088|||||||Kruskal-Wallis|||||||.088
71924675|NCT04278846|143369987|SUPERIORITY|||||||0.42|||||||Kruskal-Wallis|||||||.42
71924676|NCT04278846|143369988|SUPERIORITY|||||||0.88|||||||Kruskal-Wallis|||||||.88
71924677|NCT04278846|143369990|SUPERIORITY|||||||0.12|||||||Kruskal-Wallis|||||||.12
71924678|NCT04278846|143369991|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||.96
71924679|NCT04278846|143369992|SUPERIORITY|||||||0.76|||||||t-test, 2 sided|||||||.76
71924680|NCT04278846|143369993|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||.88
71924681|NCT04278846|143369994|SUPERIORITY|||||||0.37|||||||t-test, 2 sided|||||||.37
71924682|NCT01539512|143370004|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.1|0.32|||Log Rank|P-value is from stratified log-rank test, adjusted for randomization stratification factors.||||0.32|0.10|< 0.0001
71924683|NCT01539512|143370007|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||||TWO_SIDED|95.0|0.11|0.69||||||||0.69|0.11|
71924684|NCT01333501|143370034|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|2.7||0.494|TWO_SIDED|95.0|-3.51|7.23|||ANCOVA|||||7.23|-3.51|0.4940
71924685|NCT01333501|143370035|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.97|STANDARD_ERROR_OF_MEAN|3.03||0.5183|TWO_SIDED|95.0|-4.06|7.99|||ANCOVA|||||7.99|-4.06|0.5183
71924686|NCT01333501|143370036|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6|STANDARD_ERROR_OF_MEAN|1.05||0.1334|TWO_SIDED|95.0|-3.69|0.5|||ANCOVA|||||0.50|-3.69|0.1334
71924687|NCT01333501|143370037|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|2.29||0.4501|TWO_SIDED|95.0|-6.27|2.81|||ANCOVA|||||2.81|-6.27|0.4501
71924688|NCT01333501|143370038|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|2.53||0.8561|TWO_SIDED|95.0|-4.57|5.49|||ANCOVA|||||5.49|-4.57|0.8561
71924689|NCT01333501|143370039|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|2.53||0.8858|TWO_SIDED|95.0|-4.67|5.4|||ANCOVA|||||5.40|-4.67|0.8858
71924690|NCT01333501|143370040|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.47||0.7119|TWO_SIDED|95.0|-0.76|1.11|||ANCOVA|||||1.11|-0.76|0.7119
71924691|NCT01333501|143370041|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.42||0.9496|TWO_SIDED|95.0|-0.86|0.81|||ANCOVA|||||0.81|-0.86|0.9496
71924692|NCT01333501|143370042|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|1.18||0.8944|TWO_SIDED|95.0|-2.18|2.5|||ANCOVA|||||2.50|-2.18|0.8944
71924693|NCT01333501|143370043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.59||0.6757|TWO_SIDED|95.0|-1.42|0.92|||ANCOVA|||||0.92|-1.42|0.6757
71924694|NCT01333501|143370044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.16|STANDARD_ERROR_OF_MEAN|2.34||0.3585|TWO_SIDED|95.0|-6.82|2.5|||ANCOVA|||||2.50|-6.82|0.3585
71924695|NCT01333501|143370045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.24|STANDARD_ERROR_OF_MEAN|3.69||0.161|TWO_SIDED|95.0|-12.62|2.14|||ANCOVA|||||2.14|-12.62|0.1610
71924696|NCT00674440|143370055|OTHER||Sensitivity|93.0|||||TWO_SIDED|95.0|80.9|98.5||||||||98.5|80.9|
71924697|NCT00674440|143370055|OTHER||Specifity|88.5|||||TWO_SIDED|95.0|76.6|95.6||||||||95.6|76.6|
71924698|NCT01728194|143370093|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||< 0.025
71924699|NCT01728194|143370094|OTHER||||||<|0.025|||||||Mixed Models Analysis|||||||<0.025
71689056|NCT02688764|142893803|SUPERIORITY|||||||0.1465||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.1465
71689057|NCT02688764|142893806|SUPERIORITY|||||||0.0872||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects||||0.0872
71689058|NCT02688764|142893807|SUPERIORITY|||||||0.6207||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.6207
71689059|NCT02688764|142893807|SUPERIORITY|||||||0.3226||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.||||0.3226
71689060|NCT02688764|142893825|SUPERIORITY|||||||0.5682||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=2 years to \<6 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5682
71689061|NCT02688764|142893825|SUPERIORITY|||||||0.2271||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=6 years to \<12 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.2271
71924700|NCT04604015|143370115|OTHER||absolute difference|41.0|||<|0.001|TWO_SIDED|95.0|32.9|50.2|||McNemar|||The study was powered based on the results of a meta-analysis reporting the pooled NeuralBot (TCD) sensitivity for Right to Left Shunt detection, and the pooled TTE sensitivity for Right to Left Shunt detection.||50.2|32.9|<0.001
71924701|NCT02129192|143370116|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|95.77|||||TWO_SIDED|90.0|88.89|103.17|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.17|88.89|
71924702|NCT02129192|143370116|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.4|||||TWO_SIDED|90.0|99.7|103.13|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.13|99.70|
71924703|NCT02129192|143370116|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.77|||||TWO_SIDED|90.0|98.46|105.19|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||105.19|98.46|
71924704|NCT02129192|143370117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|30.15||||1|TWO_SIDED|90.0|24.99|36.38|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||36.38|24.99|1.0000
71924705|NCT02129192|143370117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|98.23|||<|0.0001|TWO_SIDED|90.0|94.63|101.97|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||101.97|94.63|<0.0001
71689062|NCT02688764|142893825|SUPERIORITY|||||||0.022||||||0.05 level of significance|t-test, 2 sided|||"Age group of \>=12 years to \<=18 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0220
71689063|NCT02688764|142893826|SUPERIORITY|||||||0.0058||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline above Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.0058
71689064|NCT02688764|142893826|SUPERIORITY|||||||0.5801||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline below or within Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."||||0.5801
71689065|NCT00885378|142893830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.51|STANDARD_ERROR_OF_MEAN|6.162||0.1248|TWO_SIDED|95.0|-21.68|2.66|||ANCOVA|ANCOVA model: post - pre = pretreatment.|Estimate = adjusted mean change for Saxagliptin - adjusted mean change for Placebo.|||2.66|-21.68|0.1248
71689066|NCT00885378|142893831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|||||TWO_SIDED|95.0|1.1|25.4|||||Adjusted for baseline.|||25.4|1.1|
71689067|NCT00885378|142893832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.8|||||TWO_SIDED|95.0|3.0|24.7|||||Adjusted for baseline.|||24.7|3.0|
71689068|NCT00885378|142893839|SUPERIORITY_OR_OTHER||Standard Error of the Mean|-0.34||||0.0063|TWO_SIDED|95.0|-0.58|-0.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo at Week 12(LOCF) was adjusted for baseline.|difference between week t value - baseline value = baseline value + treatment.|||-0.10|-0.58|0.0063
71689069|NCT05725824|142893875|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
71689070|NCT05725824|142893876|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
71689071|NCT05725824|142893877|SUPERIORITY||||||<|0.05||||||Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.|Repeated Measure Analysis of Variance|||||||<0.05
71924706|NCT02129192|143370117|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|79.69||||0.5422|TWO_SIDED|90.0|74.97|84.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||84.71|74.97|0.5422
71924707|NCT02129192|143370118|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|99.21|||||TWO_SIDED|90.0|96.14|102.38|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||102.38|96.14|
71924708|NCT02129192|143370118|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.43||||||90.0|99.84|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||103.04|99.84|
71924709|NCT02129192|143370118|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|100.33|||||TWO_SIDED|90.0|98.29|102.4|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.40|98.29|
71924710|NCT02129192|143370119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|63.66||||1|TWO_SIDED|90.0|58.98|68.71|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||68.71|58.98|1.0000
71924711|NCT02129192|143370119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.74|||<|0.0001|TWO_SIDED|90.0|97.08|102.48|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.48|97.08|<0.0001
71924712|NCT02129192|143370119|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.66||||0.0001|TWO_SIDED|90.0|85.8|93.7|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.70|85.80|0.0001
71689072|NCT05725824|142893878|SUPERIORITY||||||<|0.05|||||||Repeated Measure Analysis of Variance|||||||<0.05
71689073|NCT03252145|142893923|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
71689074|NCT03252145|142893924|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71689075|NCT03252145|142893925|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
71689076|NCT03252145|142893926|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71689077|NCT03252145|142893927|OTHER|||||||0.552|||||||t-test, 2 sided|||||||0.552
71689078|NCT03252145|142893928|OTHER|||||||0.498|||||||t-test, 2 sided|||||||0.498
71689079|NCT03252145|142893929|OTHER|||||||0.264|||||||t-test, 2 sided|||Affected Arm Only||||0.264
71689080|NCT03252145|142893929|OTHER|||||||0.224|||||||t-test, 2 sided|||Unaffected arm||||0.224
71689081|NCT03252145|142893930|OTHER|||||||0.125|||||||t-test, 2 sided|||Affected arm||||0.125
71689082|NCT03252145|142893930|OTHER|||||||0.241|||||||t-test, 2 sided|||Unaffected arm||||0.241
71689083|NCT03252145|142893931|OTHER|||||||0.261|||||||t-test, 2 sided|||Affected Arm||||0.261
71689084|NCT03252145|142893931|OTHER|||||||0.597|||||||t-test, 2 sided|||Unaffected Arm||||0.597
71689085|NCT03252145|142893932|OTHER|||||||0.596|||||||t-test, 2 sided|||Affected arm||||0.596
71689086|NCT03252145|142893932|OTHER|||||||0.219|||||||t-test, 2 sided|||Unaffected arm||||0.219
71689087|NCT03252145|142893933|OTHER|||||||0.842|||||||t-test, 2 sided|||||||0.842
71689088|NCT03252145|142893934|OTHER|||||||0.772|||||||t-test, 2 sided|||||||0.772
71689089|NCT03252145|142893935|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
71689090|NCT03252145|142893936|OTHER|||||||0.3|||||||t-test, 2 sided|||||||0.300
71689091|NCT03252145|142893937|OTHER|||||||0.679|||||||t-test, 2 sided|||||||0.679
71689092|NCT03252145|142893938|OTHER|||||||0.12|||||||t-test, 2 sided|||||||0.120
71689093|NCT03252145|142893939|OTHER|||||||0.138|||||||t-test, 2 sided|||||||0.138
71689094|NCT03252145|142893940|OTHER|||||||0.096|||||||t-test, 2 sided|||||||0.096
71689095|NCT03252145|142893941|OTHER|||||||0.206|||||||t-test, 2 sided|||||||0.206
71924713|NCT02129192|143370120|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|99.62|||||TWO_SIDED|90.0|96.32|103.04|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for telmisartan 80 mg||103.04|96.32|
71924714|NCT02129192|143370120|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|101.21|||||TWO_SIDED|90.0|99.59|102.87|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for amlodipine 5 mg||102.87|99.59|
71924715|NCT02129192|143370120|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|100.15|||||TWO_SIDED|90.0|98.23|102.1|||Mixed Models Analysis|"Model on logarithmic scale included subjects within sequence as random effect and sequence, period, and treatment as fixed effects."|Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by-treatment means on the log-transformed scale for hydrochlorothiazide 12.5 mg||102.10|98.23|
71924716|NCT02129192|143370121|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|64.4||||1|TWO_SIDED|90.0|59.59|69.59|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for telmisartan 80 mg. No hypothesis was tested.||69.59|59.59|1.0000
71924717|NCT02129192|143370121|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|99.45|||<|0.0001|TWO_SIDED|90.0|96.69|102.29|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for amlodipine 5 mg. No hypothesis was tested.||102.29|96.69|<0.0001
71924718|NCT02129192|143370121|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio (%)|89.82|||<|0.0001|TWO_SIDED|90.0|86.02|93.79|||ANOVA|"Model included subject as random effect and feeding condition as fixed effect."|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by-treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.||93.79|86.02|<0.0001
71924719|NCT01231620|143370125|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.73||||0.25|TWO_SIDED|95.0|-1.79|0.75|||Wilcoxon rank sum||IV Zanamivir 300 mg versus IV Zanamivir 600 mg|||0.75|-1.79|0.25
71924720|NCT01231620|143370125|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.48||||0.39|TWO_SIDED|95.0|-2.11|0.97|||Wilcoxon rank sum||Oral oseltamivir 75 mg versus IV Zanamivir 600 mg|||0.97|-2.11|0.39
71924721|NCT01231620|143370126|SUPERIORITY_OR_OTHER|||||||0.506|||||||Wei-Johnson method|||||||0.506
71924722|NCT01231620|143370126|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wei-Johnson method|||||||0.41
71924723|NCT02486263|143370200|SUPERIORITY|||||||0.28||||||The threshold for statistical significance was \<0.05.|Chi-squared|||||||0.28
71924724|NCT02486263|143370201|SUPERIORITY||Odds Ratio (OR)|0.8||||0.99|TWO_SIDED|95.0|0.4|1.6||Used Bonferroni adjustment for multiple comparisons. Threshold for statistical significance was p\<0.05|Generalized Estimation Equation||Data presented as OR (95% CI) using Generalized Estimation Equation (GEE) model with Conventional as reference.|Generalized Estimation Equation (GEE) model was used for the comparison of differences between intervention groups from week 0 to week 5 for peristaltic response frequency.||1.6|0.4|0.99
71924725|NCT02486263|143370202|SUPERIORITY|Weight velocity in grams/day||||||0.64|||||||t-test, 2 sided|||||||0.64
71924726|NCT02486263|143370203|SUPERIORITY|||||||0.11|||||||Chi-squared|||||||0.11
71924727|NCT02486263|143370204|SUPERIORITY|||||||0.49||||||Threshold for statistical significance \<0.05|Chi-squared|||||||0.49
71924728|NCT00976521|143370218|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.034
71924729|NCT00976521|143370219|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.||||0.51
71924730|NCT03039699|143370227|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71924731|NCT03039699|143370228|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0675
71924732|NCT03039699|143370228|SUPERIORITY|||||||0.0675||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0675
71689096|NCT03252145|142893943|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
71924733|NCT03039699|143370228|SUPERIORITY|||||||0.5569||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.5569
71924734|NCT03039699|143370229|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||48 hours timepoint comparison||||0.0696
71924735|NCT03039699|143370229|SUPERIORITY|||||||0.0696||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||72 hours timepoint comparison||||0.0696
71924736|NCT03039699|143370229|SUPERIORITY|||||||0.1998||||||p-value adjusted for multiple comparisons using Holm method|Fisher Exact|||96 hours timepoint comparison||||0.1998
71924737|NCT03039699|143370230|SUPERIORITY|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||||||0.0039
71924738|NCT03039699|143370231|SUPERIORITY|||||||0.89||||||"The p-value associated with treatment\*visit interaction of total CDS score from 24 hours to 48 and 72 hours of treatment between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.89
71924739|NCT03039699|143370232|SUPERIORITY|||||||0.0044|||||||Wilcoxon (Mann-Whitney)|||||||0.0044
71924740|NCT03039699|143370233|SUPERIORITY|||||||0.5488||||||nonadjusted p-value|Fisher Exact|||Day 3 comparison||||0.5488
71924741|NCT03039699|143370233|SUPERIORITY|||||||0.814||||||nonadjusted p-value|Fisher Exact|||Day 4 comparison||||0.8140
71924742|NCT03039699|143370233|SUPERIORITY|||||||0.1248||||||nonadjusted p-value|Fisher Exact|||Day 6 comparison||||0.1248
71924743|NCT03039699|143370233|SUPERIORITY|||||||0.3889||||||nonadjusted p-value|Fisher Exact|||Day 10 comparison||||0.3889
71924744|NCT03039699|143370234|SUPERIORITY|||||||0.3593|||||||Fisher Exact|||||||0.3593
71924745|NCT00129220|143370235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.62|||<|0.001|TWO_SIDED|95.0|-8.87|-2.37|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-2.37|-8.87|<0.001
71924746|NCT00129220|143370236|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.78||||0.774|TWO_SIDED|95.0|-6.15|4.59|||ANCOVA||Least Squares Mean Difference = Olazapine minus Haloperidol.|||4.59|-6.15|0.774
71924747|NCT00129220|143370237|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|21.0||||0.064|TWO_SIDED|95.0|1.6|40.4|||Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||40.4|1.6|0.064
71924748|NCT00129220|143370238|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.171|TWO_SIDED|95.0|-1.15|0.21|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.21|-1.15|0.171
71924749|NCT00129220|143370239|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.51||||0.006|TWO_SIDED|95.0|-0.87|-0.15||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.15|-0.87|0.006
71924750|NCT00129220|143370239|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.13||||0.722|TWO_SIDED|95.0|-0.82|0.57||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||0.57|-0.82|0.722
71924751|NCT00129220|143370240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.7||||0.333|TWO_SIDED|95.0|-6.7|20.1||P-value for 3-Week Response Rate.|Cochran-Mantel-Haenszel|||||20.1|-6.7|0.333
71924752|NCT00129220|143370240|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.908|TWO_SIDED|95.0|-21.0|18.4||P-value for 6-Week Response Rate.|Cochran-Mantel-Haenszel|||||18.4|-21.0|0.908
71924753|NCT00129220|143370241|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|5.9||||0.384|TWO_SIDED|95.0|-7.3|19.2||P-value for 3-Week Remission Rate.|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Placebo.|||19.2|-7.3|0.384
71924754|NCT00129220|143370241|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3||||0.982|TWO_SIDED|95.0|-21.3|21.8||P-value is for 6-Week Remission Rate|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||21.8|-21.3|0.982
71924755|NCT00129220|143370242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8||||0.698|TWO_SIDED|95.0|-3.2|4.9||P-value for 3-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||4.9|-3.2|0.698
71924756|NCT00129220|143370242|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.1||||0.014|TWO_SIDED|95.0|-31.7|3.4||P-value for 6-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel|||||3.4|-31.7|0.014
71924757|NCT00129220|143370243|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.48||||0.019|TWO_SIDED|95.0|-2.71|-0.25||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.|||-0.25|-2.71|0.019
71924758|NCT00129220|143370243|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.16||||0.855|TWO_SIDED|95.0|-1.95|1.62||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.|||1.62|-1.95|0.855
71924759|NCT00129220|143370244|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.6||||0.136|TWO_SIDED|95.0|-14.9|5.7||P-value for 6-Week Syndromic Depression Rate.|Cochran-Mantel-Haenszel|||||5.7|-14.9|0.136
71924760|NCT00129220|143370245|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Maximum Change from Baseline.|Wilcoxon Rank Sum|||||||0.003
71924761|NCT01883362|143370246|SUPERIORITY||Hazard Ratio (HR)|0.46||||0.2655|TWO_SIDED|95.0|0.12|1.86|||Log Rank|||||1.86|0.12|0.2655
71924762|NCT01883362|143370247|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
71924763|NCT01883362|143370248|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.2424|TWO_SIDED|95.0|0.2|1.52|||Log Rank|||||1.52|0.20|0.2424
71924764|NCT01883362|143370249|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.4297|TWO_SIDED|95.0|0.17|2.14|||Log Rank|||||2.14|0.17|0.4297
71924765|NCT01883362|143370250|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.3418|TWO_SIDED|95.0|0.19|1.79|||Log Rank|||||1.79|0.19|0.3418
71924766|NCT01883362|143370251|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.4169|TWO_SIDED|95.0|0.09|2.74|||Log Rank|||||2.74|0.09|0.4169
71924767|NCT02883400|143370275|SUPERIORITY||Mean Difference (Final Values)|5.0||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71924768|NCT00798161|143370288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.79|-0.36||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.36|-0.79|<0.0001
71924769|NCT00798161|143370288|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.3||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.30|-0.73|<0.0001
71924770|NCT00798161|143370288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.99|-0.55||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.55|-0.99|<0.0001
71924771|NCT00798161|143370288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.36|-0.92||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.92|-1.36|<0.0001
71924772|NCT00798161|143370289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.56|-0.26|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.26|-0.56|<0.0001
71689097|NCT03252145|142893944|OTHER|||||||0.068|||||||t-test, 2 sided|||Physical Function Domain||||0.068
71689098|NCT03252145|142893944|OTHER|||||||0.808|||||||t-test, 2 sided|||Anxiety Domain||||0.808
71924773|NCT00798161|143370289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.53|-0.23|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.23|-0.53|<0.0001
71924774|NCT00798161|143370289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.65|-0.35|||ANCOVA|||Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg||-0.35|-0.65|<0.0001
71924775|NCT00798161|143370289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.79|-0.48|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.48|-0.79|<0.0001
71924776|NCT00798161|143370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.72|-0.31|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.31|-0.72|<0.0001
71924777|NCT00798161|143370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-0.63|-0.22|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.22|-0.63|<0.0001
71924778|NCT00798161|143370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.92|-0.51|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.51|-0.92|<0.0001
71924779|NCT00798161|143370290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001||95.0|-1.16|-0.75|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.75|-1.16|<0.0001
71924780|NCT00798161|143370291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.73|-0.29|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.29|-0.73|<0.0001
71924781|NCT00798161|143370291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.69|-0.26|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.26|-0.69|<0.0001
71924782|NCT00798161|143370291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-0.94|-0.49|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-0.49|-0.94|<0.0001
71924783|NCT00798161|143370291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001||95.0|-1.3|-0.86|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-0.86|-1.30|<0.0001
71924784|NCT00798161|143370292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|5.0||0.0005||95.0|-27.2|-7.6|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-7.6|-27.2|0.0005
71924785|NCT00798161|143370292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.2|STANDARD_ERROR_OF_MEAN|5.0||0.0006||95.0|-27.1|-7.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.3|-27.1|0.0006
71924786|NCT00798161|143370292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.6|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-34.4|-14.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-14.8|-34.4|<0.0001
71924787|NCT00798161|143370292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-40.8|STANDARD_ERROR_OF_MEAN|5.0|<|0.0001||95.0|-50.6|-31.0|||ANCOVA|||Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg||-31.0|-50.6|<0.0001
71924788|NCT00798161|143370293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.9|STANDARD_ERROR_OF_MEAN|4.1||0.0003||95.0|-22.9|-6.8|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-6.8|-22.9|0.0003
71924789|NCT00798161|143370293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-24.9|-8.8|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.8|-24.9|<0.0001
71924790|NCT00798161|143370293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-29.5|-13.4|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-13.4|-29.5|<0.0001
71924791|NCT00798161|143370293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.6|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001||95.0|-33.6|-17.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-17.6|-33.6|<0.0001
71924792|NCT00798161|143370294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-26.7|-9.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-9.1|-26.7|<0.0001
71924793|NCT00798161|143370294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|4.5||0.0002||95.0|-25.6|-7.9|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-7.9|-25.6|0.0002
71924794|NCT00798161|143370294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.9|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-36.7|-19.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-19.1|-36.7|<0.0001
71924795|NCT00798161|143370294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-37.6|STANDARD_ERROR_OF_MEAN|4.5|<|0.0001||95.0|-46.4|-28.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.8|-46.4|<0.0001
71689099|NCT03252145|142893944|OTHER|||||||0.557|||||||t-test, 2 sided|||Depression Domain||||0.557
71689100|NCT03252145|142893944|OTHER|||||||0.049|||||||t-test, 2 sided|||Fatigue Domain||||0.049
71689101|NCT03252145|142893944|OTHER|||||||0.279|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.279
71689102|NCT03252145|142893944|OTHER|||||||0.02|||||||t-test, 2 sided|||Roles/Activity Domain||||0.020
71689103|NCT03252145|142893944|OTHER|||||||0.009|||||||t-test, 2 sided|||Pain Interference Domain||||0.009
71689104|NCT03252145|142893945|OTHER|||||||0.038|||||||t-test, 2 sided|||Physical Function Domain||||0.038
71689105|NCT03252145|142893945|OTHER|||||||0.108|||||||t-test, 2 sided|||Anxiety Domain||||0.108
71689106|NCT03252145|142893945|OTHER|||||||0.467|||||||t-test, 2 sided|||Depression Domain||||0.467
71689107|NCT03252145|142893945|OTHER|||||||0.078|||||||t-test, 2 sided|||Fatigue Domain||||0.078
71689108|NCT03252145|142893945|OTHER|||||||0.147|||||||t-test, 2 sided|||Sleep Disturbance Domain||||0.147
71689109|NCT03252145|142893945|OTHER|||||||0.004|||||||t-test, 2 sided|||Roles/Activity Domain||||0.004
71689110|NCT03252145|142893945|OTHER|||||||0.032|||||||t-test, 2 sided|||Pain Interference Domain||||0.032
71689111|NCT03252145|142893946|OTHER|||||||0.938|||||||t-test, 2 sided|||||||0.938
71689112|NCT03252145|142893947|OTHER|||||||0.603|||||||t-test, 2 sided|||||||0.603
71689113|NCT03252145|142893948|OTHER|||||||0.837|||||||t-test, 2 sided|||||||0.837
71689114|NCT03252145|142893949|OTHER|||||||0.511|||||||t-test, 2 sided|||||||0.511
71924796|NCT00798161|143370295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|4.7||0.0024||95.0|-23.7|-5.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-5.1|-23.7|0.0024
71924797|NCT00798161|143370295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.0|STANDARD_ERROR_OF_MEAN|4.8||0.0002||95.0|-27.4|-8.7|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.7|-27.4|0.0002
71924798|NCT00798161|143370295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.8|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-37.1|-18.5|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-18.5|-37.1|<0.0001
71924799|NCT00798161|143370295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.5|STANDARD_ERROR_OF_MEAN|4.7|<|0.0001||95.0|-50.8|-32.2|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-32.2|-50.8|<0.0001
71924800|NCT00798161|143370296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.4|-11.4|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||-11.4|-30.4|<0.0001
71689115|NCT03252145|142893950|OTHER|||||||0.326|||||||t-test, 2 sided|||||||0.326
71689116|NCT04336475|142893958|SUPERIORITY|||||||0.564||||||The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)|ANOVA|Repeated Measures ANOVA||||||0.564
71689117|NCT01267929|142893964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1|STANDARD_ERROR_OF_MEAN|2.14||0.34|TWO_SIDED|95.0|-2.3|6.5||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the second month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.||6.5|-2.3|0.34
71924801|NCT00798161|143370296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.9|STANDARD_ERROR_OF_MEAN|4.9||0.0003||95.0|-27.4|-8.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||-8.3|-27.4|0.0003
71924802|NCT00798161|143370296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.4|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-35.0|-15.9|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-15.9|-35.0|<0.0001
71924803|NCT00798161|143370296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-39.0|STANDARD_ERROR_OF_MEAN|4.9|<|0.0001||95.0|-48.5|-29.4|||ANCOVA|||Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg||-29.4|-48.5|<0.0001
71924804|NCT00798161|143370297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.372||||0.0062||95.0|1.278|4.402|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||4.402|1.278|0.0062
71924805|NCT00798161|143370297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.163|||<|0.0001||95.0|2.343|7.397|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.397|2.343|<0.0001
71924806|NCT00798161|143370297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.854|||<|0.0001||95.0|2.363|9.973|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||9.973|2.363|<0.0001
71924807|NCT00798161|143370297|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.094|||<|0.0001||95.0|8.238|35.471|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||35.471|8.238|<0.0001
71924808|NCT00798161|143370299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.465||||0.0102||95.0|1.342|8.943|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||8.943|1.342|0.0102
71924809|NCT00798161|143370299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.521||||0.0004||95.0|1.747|7.094|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||7.094|1.747|0.0004
71689118|NCT01267929|142893964|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7|STANDARD_ERROR_OF_MEAN|2.7||0.78|TWO_SIDED|95.0|-6.3|4.7||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the sixth month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.||4.7|-6.3|0.78
71689119|NCT01515696|142893983|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0||||0.61||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.61
71689120|NCT01515696|142893984|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.5||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71689121|NCT01515696|142893985|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Chi-squared|||||||>0.05
71689122|NCT01188668|142893998|SUPERIORITY_OR_OTHER||ratio of adjusted means|105.97|||||TWO_SIDED|90.0|101.39|110.76|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||110.76|101.39|
71689123|NCT01188668|142893999|SUPERIORITY_OR_OTHER||ratio of adjusted means|101.05|||||TWO_SIDED|90.0|92.94|109.87|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||109.87|92.94|
71689124|NCT01188668|142894004|SUPERIORITY_OR_OTHER||ratio of adjusted means|102.93|||||TWO_SIDED|90.0|94.21|112.46|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||112.46|94.21|
71689125|NCT01188668|142894005|SUPERIORITY_OR_OTHER||ratio of adjusted means|106.27|||||TWO_SIDED|90.0|100.97|111.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)||111.85|100.97|
71924810|NCT00798161|143370299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.521||||0.0053||95.0|1.564|13.069|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||13.069|1.564|0.0053
71924811|NCT00798161|143370299|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.947|||<|0.0001||95.0|4.314|33.08|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||33.080|4.314|<0.0001
71924812|NCT00798161|143370301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.181|||<|0.0001||95.0|1.903|5.316|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||5.316|1.903|<0.0001
71924813|NCT00798161|143370301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.382||||0.0027||95.0|1.352|4.196|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||4.196|1.352|0.0027
71924814|NCT00798161|143370301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.622|||<|0.0001||95.0|2.153|6.093|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||6.093|2.153|<0.0001
71924815|NCT00798161|143370301|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.529|||<|0.0001||95.0|3.724|11.445|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||11.445|3.724|<0.0001
71924816|NCT00798161|143370302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|22.7||0.8893||95.0|-48.5|42.2|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg||42.2|-48.5|0.8893
71924817|NCT00798161|143370302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.0|STANDARD_ERROR_OF_MEAN|22.1||0.3234||95.0|-66.2|22.2|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg||22.2|-66.2|0.3234
71924818|NCT00798161|143370302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.8|STANDARD_ERROR_OF_MEAN|23.8||0.0373||95.0|-98.5|-3.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg||-3.1|-98.5|0.0373
71924819|NCT00798161|143370302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-73.9|STANDARD_ERROR_OF_MEAN|22.7||0.0018||95.0|-119.3|-28.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg||-28.6|-119.3|0.0018
71924820|NCT00798161|143370305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.326||||0.0445|TWO_SIDED|95.0|0.109|0.973|||Regression, Logistic|||||0.973|0.109|0.0445
71924821|NCT00798161|143370305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.274||||0.0151|TWO_SIDED|95.0|0.096|0.779|||Regression, Logistic|||||0.779|0.096|0.0151
71924822|NCT00798161|143370305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.42||||0.049|TWO_SIDED|95.0|0.177|0.996|||Regression, Logistic|||||0.996|0.177|0.0490
71924823|NCT00798161|143370305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.598||||0.2617|TWO_SIDED|95.0|0.244|1.467|||Regression, Logistic|||||1.467|0.244|0.2617
71924824|NCT01982942|143370324|SUPERIORITY|||||||0.04|||||||t-test, 2 sided|||The null hypothesis states that the BPF rates of change in the treatment and placebo groups are equal, which can be evaluated based on as assessment of parameter estimates from a linear mixed model (LMM).||||0.04
71924825|NCT02918968|143370346|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.29|0.61||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||0.61|0.29|<0.001
71924826|NCT02918968|143370348|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|37.8|||<|0.001|TWO_SIDED|95.0|25.2|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|\>=50% reduction||50.4|25.2|<0.001
71924827|NCT02918968|143370348|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|38.4|||<|0.001|TWO_SIDED|95.0|26.3|50.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥ 90% reduction||50.4|26.3|<0.001
71924828|NCT02918968|143370349|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|40.7|||<|0.001|TWO_SIDED|95.0|28.3|53.1||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate.|≥ 50% reduction||53.1|28.3|<0.001
71924829|NCT02918968|143370349|SUPERIORITY|The significance level was 0.05 (two-sided).|Risk Difference (RD)|33.5|||<|0.001|TWO_SIDED|95.0|21.5|45.4||P-value is based on Cochran-Mantel-Haenszel mean score test stratified disease stages (M0/N0, M0/N1, or M1).|Mantel Haenszel|Mantel Haenszel common risk difference|Difference of response rate|≥90% reduction||45.4|21.5|<0.001
71924830|NCT02918968|143370350|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
71924831|NCT02918968|143370351|SUPERIORITY|The significance level was 0.05 (two-sided).|||||<|0.001||||||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1).|Log Rank|||||||<0.001
71924832|NCT02918968|143370353|SUPERIORITY|The significance level was 0.05 (two-sided).|Hazard Ratio (HR)|0.87||||0.669|TWO_SIDED|95.0|0.45|1.67||P-value is based on a log-rank test stratified disease stages (M0/N0, M0/N1, or M1)|Log Rank||Hazard ratio and P-value calculated using unstratified Cox proportional hazards model with treatment and disease stages (M0/N0, M0/N1, or M1) as covariate.|||1.67|0.45|0.669
71689126|NCT02081001|142894014|SUPERIORITY_OR_OTHER||Point estimate ratio|2.06|STANDARD_ERROR_OF_MEAN|1.19||0.23|TWO_SIDED|90.0|0.74|5.75|||Mixed Models Analysis|||||5.75|0.74|0.23
71689127|NCT02081001|142894014|SUPERIORITY_OR_OTHER||Point estimate ratio|1.25|STANDARD_ERROR_OF_MEAN|0.43||0.52|TWO_SIDED|90.0|0.69|2.28|||Mixed Models Analysis|||||2.28|0.69|0.52
71689128|NCT02081001|142894014|SUPERIORITY_OR_OTHER||Point estimate ratio|0.86|STANDARD_ERROR_OF_MEAN|0.19||0.49|TWO_SIDED|90.0|0.59|1.25|||Mixed Models Analysis|||||1.25|0.59|0.49
71689129|NCT02081001|142894015|SUPERIORITY_OR_OTHER||Point estimate ratio|1.37|STANDARD_ERROR_OF_MEAN|0.34||0.23|TWO_SIDED|90.0|0.88|2.12|||Mixed Models Analysis|||||2.12|0.88|0.23
71689130|NCT02081001|142894015|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.18||0.09|TWO_SIDED|90.0|1.01|1.65|||Mixed Models Analysis|||||1.65|1.01|0.09
71689131|NCT02081001|142894015|SUPERIORITY_OR_OTHER||Point estimate ratio|1.36|STANDARD_ERROR_OF_MEAN|0.16||0.02|TWO_SIDED|90.0|1.11|1.67|||Mixed Models Analysis|||||1.67|1.11|0.02
71924833|NCT00727246|143370359|OTHER|||||||0.85|TWO_SIDED|95.0|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. A mean index score created as a composite cognitive performance across domains (higher t-score = higher cognition). Purpose was to serve as a measure of overall cognitive functioning for data analysis.||||.85
71924834|NCT00727246|143370360|OTHER|||||||0.329|TWO_SIDED|0.95|||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo.||||.329
71689132|NCT02081001|142894016|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.19||0.15|TWO_SIDED|90.0|0.97|1.64|||Mixed Models Analysis|||||1.64|0.97|0.15
71924835|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924836|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924837|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924838|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71689133|NCT02081001|142894016|SUPERIORITY_OR_OTHER||Point estimate ratio|1.29|STANDARD_ERROR_OF_MEAN|0.26||0.24|TWO_SIDED|90.0|0.9|1.84|||Mixed Models Analysis|||||1.84|0.90|0.24
71689134|NCT02081001|142894016|SUPERIORITY_OR_OTHER||Point estimate ratio|0.83|STANDARD_ERROR_OF_MEAN|0.15||0.31|TWO_SIDED|90.0|0.6|1.14|||Mixed Models Analysis|||||1.14|0.60|0.31
71689135|NCT02081001|142894017|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.11||0.09|TWO_SIDED|90.0|1.01|1.39|||Mixed Models Analysis|||||1.39|1.01|0.09
71689136|NCT02081001|142894017|SUPERIORITY_OR_OTHER||Point estimate ratio|1.12|STANDARD_ERROR_OF_MEAN|0.12||0.29|TWO_SIDED|90.0|0.93|1.35|||Mixed Models Analysis|||||1.35|0.93|0.29
71689137|NCT02081001|142894017|SUPERIORITY_OR_OTHER||Point estimate ratio|1.11|STANDARD_ERROR_OF_MEAN|0.09||0.24|TWO_SIDED|90.0|0.96|1.28|||Mixed Models Analysis|||||1.28|0.96|0.24
71689138|NCT02081001|142894018|SUPERIORITY_OR_OTHER||Point estimate ratio|0.91|STANDARD_ERROR_OF_MEAN|0.22||0.7|TWO_SIDED|90.0|0.6|1.38|||Mixed Models Analysis|||||1.38|0.60|0.70
71689139|NCT02081001|142894018|SUPERIORITY_OR_OTHER||Point estimate ratio|1.26|STANDARD_ERROR_OF_MEAN|0.21||0.19|TWO_SIDED|90.0|0.94|1.68|||Mixed Models Analysis|||||1.68|0.94|0.19
71689140|NCT02081001|142894018|SUPERIORITY_OR_OTHER||Point estmate ratio|1.45|STANDARD_ERROR_OF_MEAN|0.26||0.052|TWO_SIDED|90.0|1.07|1.98|||Mixed Models Analysis|||||1.98|1.07|0.052
71689141|NCT02081001|142894019|SUPERIORITY_OR_OTHER||Point estimate ratio|2.02|STANDARD_ERROR_OF_MEAN|0.95||0.16|TWO_SIDED|90.0|0.87|4.66|||Mixed Models Analysis|||||4.66|0.87|0.16
71689142|NCT02081001|142894019|SUPERIORITY_OR_OTHER||Point estimate ratio|1.31|STANDARD_ERROR_OF_MEAN|0.49||0.48|TWO_SIDED|90.0|0.68|2.54|||Mixed Models Analysis|||||2.54|0.68|0.48
71689143|NCT02081001|142894019|SUPERIORITY_OR_OTHER||Point estimate ratio|0.8|STANDARD_ERROR_OF_MEAN|0.16||0.28|TWO_SIDED|90.0|0.57|1.13|||Mixed Models Analysis|||||1.13|0.57|0.28
71689144|NCT02081001|142894020|SUPERIORITY_OR_OTHER||Point estimate ratio|1.06|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|90.0|0.87|1.3|||Mixed Models Analysis|||||1.30|0.87|0.61
71689145|NCT02081001|142894020|SUPERIORITY_OR_OTHER||Point estimate ratio|1.19|STANDARD_ERROR_OF_MEAN|0.16||0.22|TWO_SIDED|90.0|0.94|1.5|||Mixed Models Analysis|||||1.5|0.94|0.22
71689146|NCT02081001|142894020|SUPERIORITY_OR_OTHER||Point estimate ratio|0.84|STANDARD_ERROR_OF_MEAN|0.12||0.26|TWO_SIDED|90.0|0.66|1.09|||Mixed Models Analysis|||||1.09|0.66|0.26
71689147|NCT02081001|142894021|SUPERIORITY_OR_OTHER||Point estimate ratio|1.18|STANDARD_ERROR_OF_MEAN|0.14||0.19|TWO_SIDED|90.0|0.96|1.46|||Mixed Models Analysis|||||1.46|0.96|0.19
71689148|NCT02081001|142894021|SUPERIORITY_OR_OTHER||Point estimate ratio|1.15|STANDARD_ERROR_OF_MEAN|0.12||0.21|TWO_SIDED|90.0|0.95|1.38|||Regression, Cox|||||1.38|0.95|0.21
71689149|NCT02081001|142894021|SUPERIORITY_OR_OTHER||Point estimate ratio|1.13|STANDARD_ERROR_OF_MEAN|0.1||0.19|TWO_SIDED|90.0|0.97|1.31|||Mixed Models Analysis|||||1.31|0.97|0.19
71689150|NCT02081001|142894022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.4||0.24|TWO_SIDED|95.0|-17.1|4.3|||Mixed Models Analysis|||||4.3|-17.1|0.24
71689151|NCT02081001|142894022|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.4|STANDARD_ERROR_OF_MEAN|5.4||0.0005|TWO_SIDED|95.0|-30.1|-8.7|||Mixed Models Analysis|||||-8.7|-30.1|0.0005
71689152|NCT02081001|142894022|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.3|STANDARD_ERROR_OF_MEAN|5.4|<|0.0001|TWO_SIDED|95.0|-34.0|-12.6|||Mixed Models Analysis|||||-12.6|-34.0|<0.0001
71689153|NCT02081001|142894023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0|STANDARD_ERROR_OF_MEAN|1.6||0.22|TWO_SIDED|95.0|-5.1|1.2|||Mixed Models Analysis|||||1.2|-5.1|0.22
71924839|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924840|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924841|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924842|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924843|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924844|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924845|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924846|NCT03781167|143370515|SUPERIORITY|Week 26 vs Baseline|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924847|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924848|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924849|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924850|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924851|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924852|NCT03781167|143370515|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924853|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 1 vs Baseline||||>0.999
71924854|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.5095|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.5095
71924855|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6962|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.6962
71924856|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
71924857|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0324|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0324
71924858|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924859|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0072|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0072
71924860|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0129|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0129
71924861|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924862|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0119|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0119
71924863|NCT03781167|143370516|SUPERIORITY||||||=|0.22||||||A paired-sample t-test was performed to test the change from Baseline.|paired-sample t-test|||Week 26 vs Baseline||||=0.2200
71924864|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0063|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0063
71924865|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924866|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4331|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4331
71924867|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0045|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0045
71924868|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0049|||||||Wilcoxon (Mann-Whitney)|||Week 52 vs Baseline||||=0.0049
71924869|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.6312|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.6312
71924870|NCT03781167|143370516|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1892|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1892
71924871|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924872|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924873|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924874|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924875|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924876|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924877|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924878|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924879|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924880|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924881|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924882|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924883|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924884|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924885|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924886|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924887|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924888|NCT03781167|143370517|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924889|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924890|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924891|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924892|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924893|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924894|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924895|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924896|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924897|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924898|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924899|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924900|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924901|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0042|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0042
71924902|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924903|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924904|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1135|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.1135
71924905|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0029|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0029
71924906|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0026|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0026
71924907|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0034|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0034
71924908|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0103|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0103
71924909|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924910|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0493|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0493
71924911|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3003|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3003
71924912|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0354|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.0354
71924913|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2553|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2553
71924914|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.864|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.8640
71924915|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4774|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.4774
71924916|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3865|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.3865
71924917|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.1186|||||||paired-sample t-test|||Week 52 vs Baseline||||0.1186
71924918|NCT03781167|143370518|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.083|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0830
71924919|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924920|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0041|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0041
71924921|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924922|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924923|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924924|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924925|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924926|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924927|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924928|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924929|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924930|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924931|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924932|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924933|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924934|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924935|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71689154|NCT02081001|142894023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|1.6||0.58|TWO_SIDED|95.0|-4.0|2.3|||Mixed Models Analysis|||||2.3|-4.0|0.58
71689155|NCT02081001|142894023|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.6|STANDARD_ERROR_OF_MEAN|1.6||0.03|TWO_SIDED|95.0|-6.7|-0.4|||Mixed Models Analysis|||||-0.4|-6.7|0.03
71689156|NCT05816070|142894028|NON_INFERIORITY|The non-inferiority margin is -10% based on the general standard of antibacterial drug. Non-inferiority is established when P\<0.05.||||||0.0137|||||||Chi-squared|||||||0.0137
71689157|NCT00583011|142894031|EQUIVALENCE||Median Difference (Final Values)|0.02|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71689158|NCT00423813|142894093|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Overall Comparison||||0.001
71689159|NCT00423813|142894093|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 4.5g and placebo||||<0.001
71924936|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924937|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924938|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924939|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924940|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924941|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924942|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71924943|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924944|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924945|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71924946|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0091|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0091
71924947|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924948|NCT03781167|143370519|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71924949|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4447|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.4447
71924950|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3567|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.3567
71689160|NCT00423813|142894093|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Pairwise comparison of Xyrem 6.0g and placebo||||0.001
71689161|NCT01386944|142894102|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-0.5|||||TWO_SIDED|95.0|-1.0|-0.5||||||||-0.5|-1.0|
71689162|NCT01386944|142894103|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-1.5|||||TWO_SIDED|95.0|-1.5|-1.0||||||||-1.0|-1.5|
71689163|NCT01386944|142894104|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
71689164|NCT01386944|142894105|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
71689165|NCT01386944|142894106|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5||||||||-1.5|-2.5|
71689166|NCT01386944|142894107|SUPERIORITY_OR_OTHER||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5||||||||-1.5|-2.0|
71689167|NCT03883477|142894113|OTHER|The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||||0.013||||||1 week P-value|Wilcoxon (Mann-Whitney)|||||||0.013
71689168|NCT03883477|142894113|OTHER|||||||0.007||||||1 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.007
71689169|NCT03883477|142894113|OTHER|||||||0.804||||||6 month P-value|Wilcoxon (Mann-Whitney)|||The trial was powered to detect a difference in POSAS score of 10, deemed to be clinically significant by the investigators. To detect a mean difference in POSAS score of 10 points (SD = 8) with a two-sided significance level of 5% and power of 80% with equal allocation to two arms required 12 patients in each arm of the trial.||||0.804
71689170|NCT03883477|142894114|OTHER|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||||||0.142
71689171|NCT03883477|142894115|OTHER|||||||0.561|||||||Wilcoxon (Mann-Whitney)|||||||0.561
71689172|NCT03883477|142894116|OTHER|||||||0.748|||||||Wilcoxon (Mann-Whitney)|||||||0.748
71689173|NCT03883477|142894117|OTHER|||||||0.184|||||||Wilcoxon (Mann-Whitney)|||||||0.184
71689174|NCT03883477|142894118|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
71689175|NCT03883477|142894119|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
71689176|NCT03658642|142894122|SUPERIORITY||Odds Ratio (OR)|1.22||||0.58|TWO_SIDED|95.0|0.61|2.43|||GEE|Obtained from a GEE model accounting for clustering by site and multiple covariates.||||2.43|0.61|0.58
71689177|NCT03658642|142894123|SUPERIORITY||Odds Ratio (OR)|1.03||||0.95|TWO_SIDED|95.0|0.43|2.47|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.47|0.43|0.95
71689178|NCT03658642|142894125|SUPERIORITY||Odds Ratio (OR)|1.55||||0.01|TWO_SIDED|95.0|1.11|2.16|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.16|1.11|0.01
71689179|NCT03658642|142894126|SUPERIORITY||Odds Ratio (OR)|1.13||||0.48|TWO_SIDED|95.0|0.91|1.57|||GEE|Obtained from a GEE model accounting for clustering by site.||||1.57|0.91|0.48
71924951|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2315|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.2315
71924952|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0667|||||||paired-sample t-test|||Week 1 vs Baseline||||=0.0667
71924953|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924954|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924955|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924956|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2033|||||||paired-sample t-test|||Week 2 vs Baseline||||=0.2033
71924957|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924958|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0012|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0012
71924959|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0734|||||||paired-sample t-test|||Week 3 vs Baseline||||=0.0734
71924960|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924961|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0304|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0304
71924962|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||>|0.999|||||||paired-sample t-test|||Week 4 vs Baseline||||>0.999
71924963|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0891|||||||paired-sample t-test|||Week 4 vs Baseline||||=0.0891
71924964|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0832|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0832
71924965|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4941|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.4941
71924966|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2764|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.2764
71924967|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3248|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.3248
71924968|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2535|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.2535
71924969|NCT03781167|143370520|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9274|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.9274
71924970|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.3297|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.3297
71924971|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.9722|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.9722
71924972|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.4403|||||||paired-sample t-test|||Week 26 vs Baseline||||=0.4403
71924973|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1946|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.1946
71924974|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2077|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.2077
71924975|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0692|||||||paired-sample t-test|||Week 39 vs Baseline||||=0.0692
71924976|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.2276|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.2276
71924977|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.||||||0.3369|||||||paired-sample t-test|||Week 52 vs Baseline||||0.3369
71924978|NCT03781167|143370520|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.1218|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.1218
71924979|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924980|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.002|||||||paired-sample t-test|||Day 2 vs Baseline||||=0.0020
71924981|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924982|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924983|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 1 vs Baseline||||<0.001
71924984|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Day 2 vs Baseline||||<0.001
71924985|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924986|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924987|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 2 vs Baseline||||<0.001
71924988|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924989|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71924990|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 3 vs Baseline||||<0.001
71689180|NCT03658642|142894127|SUPERIORITY||Odds Ratio (OR)|1.32||||0.27|TWO_SIDED|95.0|0.81|2.14|||GEE|Obtained from a GEE model accounting for clustering by site.||||2.14|0.81|0.27
71924991|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924992|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924993|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 4 vs Baseline||||<0.001
71924994|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924995|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924996|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71924997|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924998|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71924999|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925000|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925001|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925002|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925003|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925004|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925005|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925006|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925007|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925008|NCT03781167|143370521|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925009|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925010|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925011|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925012|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925013|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925014|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925015|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925016|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925017|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925018|NCT03781167|143370522|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925019|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925020|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925021|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925022|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925023|NCT03781167|143370522|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925024|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925025|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925026|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925027|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925028|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71689181|NCT02137226|142894133|NON_INFERIORITY_OR_EQUIVALENCE|The 90% Confidence Interval (CI) for ACR20 at Week 12, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-12.0%, 15.0%\]|Difference in proportions|5.9|||||TWO_SIDED|90.0|-0.9|12.7|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 12 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.7|-0.9|
71689182|NCT02137226|142894134|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|-0.1|||||TWO_SIDED|90.0|-0.25|0.05|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 12 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.05|-0.25|
71925029|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71689183|NCT02137226|142894134|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence margin is not applicable|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-0.17|0.23|||ANCOVA||Difference in least square means of BI 695501 - Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 24 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.||0.23|-0.17|
71925030|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925031|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925032|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925033|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925034|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925035|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925036|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925037|NCT03781167|143370523|OTHER|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925038|NCT03781167|143370523|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925039|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0035|||||||paired-sample t-test|||Week 6 vs Baseline||||=0.0035
71925040|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925041|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 6 vs Baseline||||<0.001
71925042|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.0098|||||||paired-sample t-test|||Week 13 vs Baseline||||=0.0098
71925043|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925044|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 13 vs Baseline||||<0.001
71925045|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925046|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925047|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 26 vs Baseline||||<0.001
71925048|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925049|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925050|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 39 vs Baseline||||<0.001
71925051|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||=|0.003|||||||paired-sample t-test|||Week 52 vs Baseline||||=0.0030
71925052|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925053|NCT03781167|143370524|SUPERIORITY|A paired-sample t-test was performed to test the change from Baseline.|||||<|0.001|||||||paired-sample t-test|||Week 52 vs Baseline||||<0.001
71925054|NCT00398476|143370569|OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|||Analysis for overall product preference||||0.003
71925055|NCT00398476|143370569|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Scent/odor||||<0.001
71689184|NCT02137226|142894136|NON_INFERIORITY_OR_EQUIVALENCE|The 95% Confidence Interval (CI) for ACR20 at Week 24, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region \[-15.0%;+15.0%\]|Difference in proportions|4.5|||||TWO_SIDED|95.0|-3.4|12.5|||Regression, Logistic||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 - Humira, %) is presented.|The week 24 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve||12.5|-3.4|
71689185|NCT02373137|142894162|SUPERIORITY||Coefficient|-1.8|||<|0.001|TWO_SIDED|95.0|-2.8|-1.0|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity.|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.|||-1.0|-2.8|<0.001
71689186|NCT02373137|142894163|SUPERIORITY||Coefficient|-1.5||||0.002|TWO_SIDED|95.0|-2.5|-0.6|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.|Comparison of 3-Month Visual Acuity Between Groups||-0.6|-2.5|0.002
71689187|NCT02373137|142894163|SUPERIORITY||Coefficient|-1.4|||<|0.001|TWO_SIDED|95.0|-2.2|-0.7|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.|Comparison of 12 Month Visual Acuity Between Groups||-0.7|-2.2|<0.001
71689188|NCT02373137|142894165|SUPERIORITY||Coefficient|-77.0||||0.53|TWO_SIDED|95.0|-326.0|172.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 3 months.|||172|-326|0.53
71689189|NCT02373137|142894165|SUPERIORITY||Coefficient|-150.0||||0.17|TWO_SIDED|95.0|-356.0|66.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 6 months.|||66|-356|0.17
71925056|NCT00398476|143370569|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Immediate taste||||<0.001
71925057|NCT00398476|143370569|OTHER|||||||0.002|||||||Cochran-Mantel-Haenszel|||Analysis for After-taste||||0.002
71925058|NCT00398476|143370569|OTHER|||||||0.037|||||||Cochran-Mantel-Haenszel|||Analysis for Less drip down throat||||0.037
71925059|NCT00398476|143370569|OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Less run out nose||||<0.001
71925060|NCT00398476|143370569|OTHER|||||||0.408|||||||Cochran-Mantel-Haenszel|||Analysis for More soothing||||0.408
71925061|NCT00398476|143370569|OTHER|||||||0.07|||||||Cochran-Mantel-Haenszel|||Analysis for Less irritating||||0.070
71689190|NCT02373137|142894165|SUPERIORITY||Coefficient|-215.0||||0.051|TWO_SIDED|95.0|-430.0|-0.4|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 12 months.|||-0.4|-430|0.051
71689191|NCT02373137|142894171|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||0.70
71689192|NCT02559570|142894209|SUPERIORITY||Least Squares Mean Difference|-0.042|STANDARD_ERROR_OF_MEAN|0.149||0.7789|TWO_SIDED|95.0|-0.335|0.252|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.252|-0.335|0.7789
71689193|NCT02559570|142894209|SUPERIORITY||Least Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.143||0.993|TWO_SIDED|95.0|-0.282|0.284|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.284|-0.282|0.9930
71689194|NCT02559570|142894209|SUPERIORITY||Least Squares Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.146||0.4107|TWO_SIDED|95.0|-0.167|0.408|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.408|-0.167|0.4107
71689195|NCT02559570|142894210|SUPERIORITY||Least Squares Mean Difference|-0.588|STANDARD_ERROR_OF_MEAN|0.577||0.3097|TWO_SIDED|95.0|-1.729|0.552|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.552|-1.729|0.3097
71925062|NCT00398476|143370569|OTHER|||||||0.587|||||||Cochran-Mantel-Haenszel|||Analysis for Urge to sneeze||||0.587
71925063|NCT00398476|143370570|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-2.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ items||||<0.001
71925064|NCT00398476|143370570|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-1.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ items||||<0.001
71925065|NCT00398476|143370571|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.255||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||0.255
71925066|NCT00398476|143370572|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.056||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for all DAQ items||||0.056
71925067|NCT00398476|143370573|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.845||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ Irtems||||0.845
71925068|NCT00398476|143370574|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.871||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ Items||||0.871
71925069|NCT00398476|143370575|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71925070|NCT00398476|143370576|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.592||95.0|||||Cochran-Mantel-Haenszel|||||||0.592
71925071|NCT00398476|143370577|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71925072|NCT00398476|143370578|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.434||95.0|||||Cochran-Mantel-Haenszel|||||||0.434
71925073|NCT00398476|143370579|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.797
71925074|NCT00398476|143370579|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.296|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.296
71925075|NCT00398476|143370580|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ||||<0.001
71925076|NCT00398476|143370580|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in DAQ||||<0.001
71925077|NCT00398476|143370581|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.968|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ||||0.968
71925078|NCT00398476|143370581|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Mean Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ||||0.797
71925079|NCT00398476|143370582|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.221|||||||Cochran-Mantel-Haenszel|||||||0.221
71925080|NCT00398476|143370583|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.205|||||||Cochran-Mantel-Haenszel|||||||0.205
71925081|NCT00398476|143370584|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.108|||||||Cochran-Mantel-Haenszel|||||||0.108
71925082|NCT00398476|143370585|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.694|||||||Cochran-Mantel-Haenszel|||||||0.694
71925083|NCT00398476|143370586|EQUIVALENCE|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.02|||||||Cochran-Mantel-Haenszel|||||||0.020
71925084|NCT00635362|143370645|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35|TWO_SIDED||||||Fisher Exact|||||||0.35
71925085|NCT00635362|143370646|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|TWO_SIDED||||||Fisher Exact|||||||0.04
71925086|NCT00635362|143370647|SUPERIORITY_OR_OTHER_LEGACY|||||||1|TWO_SIDED|0.0|||||Fisher Exact|||||||1.000
71925087|NCT00635362|143370648|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37|TWO_SIDED|0.0|||||Fisher Exact|||||||0.37
71925088|NCT00635362|143370649|SUPERIORITY_OR_OTHER_LEGACY|||||||1||0.0|||||Fisher Exact|||||||1.00
71925089|NCT04095039|143370670|SUPERIORITY|||||||0.077||||||p-value is based on a sample that is less than 10% of the planned sample size (planned n=4,000)|Finkelstein-Schoenfeld method|||Primary outcome is for the individually randomized cohort since DSMB had concerns about selection bias for the cluster-randomized population due to differences in baseline characteristics that leaned towards the arm objectives.||||0.077
71925090|NCT02309372|143370685|SUPERIORITY||Mean Difference (Net)|-0.76||||0.32|TWO_SIDED|95.0|-2.28|0.77|||t-test, 2 sided|||||0.77|-2.28|0.32
71925091|NCT01590810|143370697|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|1.15||0.503|TWO_SIDED|95.0|-1.59|3.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.15|-1.59|0.503
71689196|NCT02559570|142894210|SUPERIORITY||Least Squares Mean Difference|-0.186|STANDARD_ERROR_OF_MEAN|0.557||0.7384|TWO_SIDED|95.0|-1.286|0.913|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.913|-1.286|0.7384
71689197|NCT02559570|142894210|SUPERIORITY||Least Squares Mean Difference|0.364|STANDARD_ERROR_OF_MEAN|0.563||0.5188|TWO_SIDED|95.0|-0.748|1.477|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||1.477|-0.748|0.5188
71689198|NCT02559570|142894211|SUPERIORITY||Least Squares Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.249||0.8426|TWO_SIDED|95.0|-0.543|0.444|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.444|-0.543|0.8426
71689199|NCT02559570|142894211|SUPERIORITY||Least Squares Mean Difference|-0.038|STANDARD_ERROR_OF_MEAN|0.246||0.877|TWO_SIDED|95.0|-0.525|0.448|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.448|-0.525|0.8770
71689200|NCT02559570|142894211|SUPERIORITY||Least Squares Mean Difference|0.356|STANDARD_ERROR_OF_MEAN|0.246||0.1502|TWO_SIDED|95.0|-0.131|0.842|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.842|-0.131|0.1502
71689201|NCT02559570|142894211|SUPERIORITY||Least Squares Mean Difference|-0.062|STANDARD_ERROR_OF_MEAN|0.239||0.7949|TWO_SIDED|95.0|-0.535|0.41|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.410|-0.535|0.7949
71689202|NCT02559570|142894211|SUPERIORITY||Least Squares Mean Difference|-0.074|STANDARD_ERROR_OF_MEAN|0.235||0.7543|TWO_SIDED|95.0|-0.54|0.392|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.392|-0.540|0.7543
71689203|NCT02559570|142894211|SUPERIORITY||Least Squares Mean Difference|0.262|STANDARD_ERROR_OF_MEAN|0.235||0.2676|TWO_SIDED|95.0|-0.204|0.728|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.728|-0.204|0.2676
71925092|NCT01590810|143370697|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.32|<|0.0001|TWO_SIDED|95.0|-2.86|-1.55|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.55|-2.86|<0.0001
71925093|NCT01590810|143370697|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.23|STANDARD_ERROR_OF_MEAN|0.92|<|0.0001|TWO_SIDED|95.0|-10.13|-6.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.34|-10.13|<0.0001
71925094|NCT01590810|143370697|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.84|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-9.1|-4.58|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.58|-9.10|<0.0001
71925095|NCT01590810|143370697|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.41|STANDARD_ERROR_OF_MEAN|1.21|<|0.0001|TWO_SIDED|95.0|-12.89|-7.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.92|-12.89|<0.0001
71689204|NCT02559570|142894212|SUPERIORITY||Least Squares Mean Difference|-0.053|STANDARD_ERROR_OF_MEAN|0.208||0.7997|TWO_SIDED|95.0|-0.465|0.359|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.359|-0.465|0.7997
71689205|NCT02559570|142894212|SUPERIORITY||Least Squares Mean Difference|-0.121|STANDARD_ERROR_OF_MEAN|0.207||0.5602|TWO_SIDED|95.0|-0.53|0.288|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.288|-0.530|0.5602
71689206|NCT02559570|142894212|SUPERIORITY||Least Squares Mean Difference|-0.236|STANDARD_ERROR_OF_MEAN|0.205||0.2529|TWO_SIDED|95.0|-0.641|0.17|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation||0.170|-0.641|0.2529
71689207|NCT02559570|142894212|SUPERIORITY||Least Squares Mean Difference|-0.054|STANDARD_ERROR_OF_MEAN|0.206||0.7923|TWO_SIDED|95.0|-0.461|0.352|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.352|-0.461|0.7923
71925096|NCT01590810|143370698|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.89|STANDARD_ERROR_OF_MEAN|1.4||0.052|TWO_SIDED|95.0|-5.79|0.02|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.02|-5.79|0.052
71925097|NCT01590810|143370698|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.46|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.49|-1.43|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.43|-9.49|0.010
71689208|NCT02559570|142894212|SUPERIORITY||Least Squares Mean Difference|-0.113|STANDARD_ERROR_OF_MEAN|0.204||0.5802|TWO_SIDED|95.0|-0.517|0.29|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.290|-0.517|0.5802
71689209|NCT02559570|142894212|SUPERIORITY||Least Squares Mean Difference|-0.199|STANDARD_ERROR_OF_MEAN|0.202||0.3263|TWO_SIDED|95.0|-0.6|0.201|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average||0.201|-0.600|0.3263
71689210|NCT02559570|142894213|SUPERIORITY||Least Squares Mean Difference|0.048|STANDARD_ERROR_OF_MEAN|0.152||0.7507|TWO_SIDED|95.0|-0.252|0.349|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.349|-0.252|0.7507
71689211|NCT02559570|142894213|SUPERIORITY||Least Squares Mean Difference|0.028|STANDARD_ERROR_OF_MEAN|0.146||0.8505|TWO_SIDED|95.0|-0.262|0.317|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.317|-0.262|0.8505
71689212|NCT02559570|142894213|SUPERIORITY||Least Squares Mean Difference|0.039|STANDARD_ERROR_OF_MEAN|0.149||0.7933|TWO_SIDED|95.0|-0.254|0.332|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.332|-0.254|0.7933
71925098|NCT01590810|143370698|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.49|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.2|-4.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.79|-14.20|<0.001
71689213|NCT02559570|142894214|SUPERIORITY||Least Squares Mean Difference|-0.425|STANDARD_ERROR_OF_MEAN|0.45||0.3461|TWO_SIDED|95.0|-1.313|0.463|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.463|-1.313|0.3461
71689214|NCT02559570|142894214|SUPERIORITY||Least Squares Mean Difference|-0.235|STANDARD_ERROR_OF_MEAN|0.435||0.5892|TWO_SIDED|95.0|-1.095|0.624|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.624|-1.095|0.5892
71689215|NCT02559570|142894214|SUPERIORITY||Least Squares Mean Difference|0.08|STANDARD_ERROR_OF_MEAN|0.44||0.856|TWO_SIDED|95.0|-0.789|0.949|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|||0.949|-0.789|0.8560
71925099|NCT01590810|143370698|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.02|STANDARD_ERROR_OF_MEAN|2.17|<|0.0001|TWO_SIDED|95.0|-16.51|-7.52|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.52|-16.51|<0.0001
71925100|NCT01590810|143370698|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-12.93|-6.53|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.53|-12.93|<0.0001
71925101|NCT01590810|143370699|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|5.61||0.48|TWO_SIDED|95.0|-16.44|8.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.25|-16.44|0.480
71925102|NCT01590810|143370699|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.79|STANDARD_ERROR_OF_MEAN|5.72||0.086|TWO_SIDED|95.0|-23.37|1.79|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.79|-23.37|0.086
71689216|NCT02526160|142894233|SUPERIORITY||||||<|0.0001||||||From Cochran-Mantel-Haenszel (CMH) testing for association between achieving mean serum phosphorus levels above lower limit of normal (LLN) and treatment group, adjusting for stratification of Brief Pain Inventory (BPI) Average Pain and region.|Cochran-Mantel-Haenszel|||||||< 0.0001
71689217|NCT02526160|142894234|SUPERIORITY||Least squares (LS) mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.275||0.0919|TWO_SIDED|95.0|-1.0|0.08||Prespecified significance level for test after Hochberg adjustment: 0.05|GEE model|||||0.08|-1.00|0.0919
71689218|NCT02526160|142894235|SUPERIORITY||LS mean difference|-8.31|STANDARD_ERROR_OF_MEAN|3.251||0.0106|TWO_SIDED|95.0|-14.68|-1.94||Prespecified significance level for test after Hochberg adjustment: 0.0167|GEE model|||||-1.94|-14.68|0.0106
71689219|NCT02526160|142894236|SUPERIORITY||LS mean difference|-4.9|STANDARD_ERROR_OF_MEAN|2.479||0.0478|TWO_SIDED|95.0|-9.76|-0.05||Prespecified significance level for test after Hochberg adjustment: 0.025|GEE model|||||-0.05|-9.76|0.0478
71689220|NCT02576977|142894266|SUPERIORITY||Hazard Ratio (HR)|1.5||||0.99324|TWO_SIDED|95.0|1.08|2.08|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|||2.08|1.08|0.99324
71689221|NCT02576977|142894267|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.99989|TWO_SIDED|95.0|1.32|2.55|||Log Rank|One-sided p-value based on Stratified log-rank test.|||The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).|2.55|1.32|0.99989
71689222|NCT02576977|142894268|SUPERIORITY||Difference in % vs. SOC|-5.2||||0.79921|TWO_SIDED|95.0|-17.1|6.9|||Miettinen & Nurminen method||||Based on Miettinen \& Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.|6.9|-17.1|0.79921
71689223|NCT04727528|142894273|SUPERIORITY||Odds Ratio (OR)|56.2||||0.001|TWO_SIDED|95.0|5.6|563.6|||Wald Chi-Squared test||Logistic regression model included response status (response / non-response) as the dependent variable and randomized treatment as an independent factor.|||563.6|5.6|0.001
71689224|NCT04727528|142894274|SUPERIORITY||Least-squares mean|1.64|STANDARD_ERROR_OF_MEAN|0.81||0.05|TWO_SIDED|95.0|0.0|3.29|||t-test, 2 sided|||Difference between groups||3.29|-0.00|0.050
71925103|NCT01590810|143370699|SUPERIORITY_OR_OTHER||LS Mean Difference|-17.51|STANDARD_ERROR_OF_MEAN|5.15||0.006|TWO_SIDED|95.0|-28.85|-6.18|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.18|-28.85|0.006
71925104|NCT01590810|143370700|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.21|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.84|-9.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.59|-16.84|<0.0001
71925105|NCT01590810|143370700|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.0001|TWO_SIDED|95.0|-13.94|-6.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.45|-13.94|<0.0001
71925106|NCT01590810|143370700|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.82|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-16.45|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.45|<0.0001
71925107|NCT01590810|143370700|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.84|STANDARD_ERROR_OF_MEAN|1.75|<|0.0001|TWO_SIDED|95.0|-16.49|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.19|-16.49|<0.0001
71689225|NCT04727528|142894275|SUPERIORITY||Odds Ratio (OR)|3.2||||0.153|TWO_SIDED|95.0|0.6|15.8|||Wald Chi-Squared test|||Comparison between groups||15.8|0.6|0.153
71689226|NCT04727528|142894276|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
71689227|NCT04727528|142894277|SUPERIORITY||Odds Ratio (OR)|2.2||||0.271|TWO_SIDED|95.0|0.5|8.6|||Wald Chi-Squared test|||Comparison between groups||8.6|0.5|0.271
71689228|NCT04727528|142894278|SUPERIORITY||Odds Ratio (OR)|10.8||||0.039|TWO_SIDED|95.0|1.1|102.8|||Wald Chi-Squared test|||Comparison between groups||102.8|1.1|0.039
71925108|NCT01590810|143370701|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.31|STANDARD_ERROR_OF_MEAN|1.18||0.061|TWO_SIDED|95.0|-4.73|0.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.11|-4.73|0.061
71925109|NCT01590810|143370701|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.23|STANDARD_ERROR_OF_MEAN|0.86||0.016|TWO_SIDED|95.0|-4.0|-0.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.45|-4.00|0.016
71925110|NCT01590810|143370701|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.62|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-14.42|-8.82|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.82|-14.42|<0.0001
71689229|NCT04727528|142894279|SUPERIORITY||Odds Ratio (OR)|57008.6||||0.94|TWO_SIDED|95.0|0.0||The upper limit of the 95% confidence interval = 13124060000000000000000000000||Wald Chi-Squared test|||Comparison between groups|||0.0|0.940
71925111|NCT01590810|143370701|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.15|STANDARD_ERROR_OF_MEAN|1.55|<|0.0001|TWO_SIDED|95.0|-11.34|-4.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.96|-11.34|<0.0001
71925112|NCT01590810|143370701|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.78|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.81|-12.75|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.75|-20.81|<0.0001
71925113|NCT01590810|143370702|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.95|STANDARD_ERROR_OF_MEAN|1.26||0.029|TWO_SIDED|95.0|-5.56|-0.34|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.34|-5.56|0.029
71925114|NCT01590810|143370702|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|2.19||0.005|TWO_SIDED|95.0|-11.29|-2.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.22|-11.29|0.005
71925115|NCT01590810|143370702|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.48|STANDARD_ERROR_OF_MEAN|3.16|<|0.001|TWO_SIDED|95.0|-20.03|-6.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.93|-20.03|<0.001
71689230|NCT01763827|142894281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.14|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-61.14|-53.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.14|-61.14|<0.001
71925116|NCT01590810|143370702|SUPERIORITY_OR_OTHER||LS Mean Difference|-18.33|STANDARD_ERROR_OF_MEAN|1.76|<|0.0001|TWO_SIDED|95.0|-21.98|-14.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-14.68|-21.98|<0.0001
71925117|NCT01590810|143370702|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.24|STANDARD_ERROR_OF_MEAN|1.96|<|0.0001|TWO_SIDED|95.0|-20.29|-12.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-12.19|-20.29|<0.0001
71925118|NCT01590810|143370703|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.59|STANDARD_ERROR_OF_MEAN|2.51||0.539|TWO_SIDED|95.0|-7.12|3.93|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.93|-7.12|0.539
71925119|NCT01590810|143370703|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.36|STANDARD_ERROR_OF_MEAN|3.12||0.113|TWO_SIDED|95.0|-12.23|1.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.50|-12.23|0.113
71925120|NCT01590810|143370703|SUPERIORITY_OR_OTHER||LS Mean Difference|-14.3|STANDARD_ERROR_OF_MEAN|2.45|<|0.001|TWO_SIDED|95.0|-19.69|-8.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.91|-19.69|<0.001
71925121|NCT01590810|143370704|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.0001|TWO_SIDED|95.0|-15.62|-9.11|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-9.11|-15.62|<0.0001
71925122|NCT01590810|143370704|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.58|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-13.74|-7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.42|-13.74|<0.0001
71925123|NCT01590810|143370704|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.63|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-16.12|-11.13|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-11.13|-16.12|<0.0001
71925124|NCT01590810|143370704|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.96|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-15.85|-10.08|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-10.08|-15.85|<0.0001
71925125|NCT01590810|143370705|SUPERIORITY_OR_OTHER||LS Mean Difference|1.05|STANDARD_ERROR_OF_MEAN|0.75||0.175|TWO_SIDED|95.0|-0.5|2.6|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.60|-0.50|0.175
71925126|NCT01590810|143370705|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|1.18||0.076|TWO_SIDED|95.0|-0.25|4.61|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||4.61|-0.25|0.076
71925127|NCT01590810|143370705|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|STANDARD_ERROR_OF_MEAN|0.55||0.001|TWO_SIDED|95.0|1.04|3.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.32|1.04|0.001
71925128|NCT01590810|143370705|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|1.22|<|0.0001|TWO_SIDED|95.0|3.14|8.15|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.15|3.14|<0.0001
71925129|NCT01590810|143370705|SUPERIORITY_OR_OTHER||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|0.74||0.008|TWO_SIDED|95.0|0.63|3.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.67|0.63|0.008
71925130|NCT01590810|143370706|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.83|STANDARD_ERROR_OF_MEAN|1.39||0.557|TWO_SIDED|95.0|-3.7|2.05|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.05|-3.70|0.557
71925131|NCT01590810|143370706|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.48|STANDARD_ERROR_OF_MEAN|1.05||0.175|TWO_SIDED|95.0|-3.65|0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.70|-3.65|0.175
71925132|NCT01590810|143370706|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09|STANDARD_ERROR_OF_MEAN|1.52||0.951|TWO_SIDED|95.0|-3.04|3.23|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.23|-3.04|0.951
71925133|NCT01590810|143370706|SUPERIORITY_OR_OTHER||LS Mean Difference|2.61|STANDARD_ERROR_OF_MEAN|0.61|<|0.001|TWO_SIDED|95.0|1.34|3.88|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.88|1.34|<0.001
71925134|NCT01590810|143370706|SUPERIORITY_OR_OTHER||LS Mean Difference|4.62|STANDARD_ERROR_OF_MEAN|0.78|<|0.0001|TWO_SIDED|95.0|3.0|6.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||6.24|3.00|<0.0001
71925135|NCT01590810|143370707|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.45|STANDARD_ERROR_OF_MEAN|1.16||0.241|TWO_SIDED|95.0|-4.01|1.12|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.12|-4.01|0.241
71925136|NCT01590810|143370707|SUPERIORITY_OR_OTHER||LS Mean Difference|0.92|STANDARD_ERROR_OF_MEAN|2.07||0.664|TWO_SIDED|95.0|-3.63|5.48|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||5.48|-3.63|0.664
71925137|NCT01590810|143370707|SUPERIORITY_OR_OTHER||LS Mean Difference|3.65|STANDARD_ERROR_OF_MEAN|2.13||0.114|TWO_SIDED|95.0|-1.03|8.33|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||8.33|-1.03|0.114
71925138|NCT01590810|143370708|SUPERIORITY_OR_OTHER||LS Mean Difference|4.42|STANDARD_ERROR_OF_MEAN|4.98||0.385|TWO_SIDED|95.0|-5.96|14.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.81|-5.96|0.385
71925139|NCT01590810|143370708|SUPERIORITY_OR_OTHER||LS Mean Difference|4.58|STANDARD_ERROR_OF_MEAN|5.15||0.385|TWO_SIDED|95.0|-6.16|15.32|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||15.32|-6.16|0.385
71925140|NCT01590810|143370708|SUPERIORITY_OR_OTHER||LS Mean Difference|5.15|STANDARD_ERROR_OF_MEAN|4.6||0.276|TWO_SIDED|95.0|-4.44|14.74|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||14.74|-4.44|0.276
71925141|NCT01590810|143370708|SUPERIORITY_OR_OTHER||LS Mean Difference|9.5|STANDARD_ERROR_OF_MEAN|4.94||0.069|TWO_SIDED|95.0|-0.81|19.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||19.81|-0.81|0.069
71925142|NCT01590810|143370709|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|1.09||0.383|TWO_SIDED|95.0|-1.28|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-1.28|0.383
71925143|NCT01590810|143370709|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.75|STANDARD_ERROR_OF_MEAN|0.51||0.002|TWO_SIDED|95.0|-2.79|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.70|-2.79|0.002
71925144|NCT01590810|143370709|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.11|STANDARD_ERROR_OF_MEAN|0.96|<|0.0001|TWO_SIDED|95.0|-10.08|-6.14|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.14|-10.08|<0.0001
71925145|NCT01590810|143370709|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.5|STANDARD_ERROR_OF_MEAN|1.58|<|0.001|TWO_SIDED|95.0|-9.74|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-9.74|<0.001
71925146|NCT01590810|143370709|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.31|STANDARD_ERROR_OF_MEAN|1.23|<|0.0001|TWO_SIDED|95.0|-12.84|-7.78|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.78|-12.84|<0.0001
71925147|NCT01590810|143370710|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.07|STANDARD_ERROR_OF_MEAN|1.62||0.216|TWO_SIDED|95.0|-5.43|1.3|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.30|-5.43|0.216
71925148|NCT01590810|143370710|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.8|STANDARD_ERROR_OF_MEAN|2.27||0.046|TWO_SIDED|95.0|-9.51|-0.1|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.10|-9.51|0.046
71925149|NCT01590810|143370710|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.93|STANDARD_ERROR_OF_MEAN|2.5||0.002|TWO_SIDED|95.0|-14.1|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-14.10|0.002
71925150|NCT01590810|143370710|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.16|STANDARD_ERROR_OF_MEAN|2.65|<|0.001|TWO_SIDED|95.0|-16.64|-5.68|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.68|-16.64|<0.001
71925151|NCT01590810|143370710|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.25|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-12.7|-5.8|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.80|-12.70|<0.0001
71925152|NCT01590810|143370711|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.27|STANDARD_ERROR_OF_MEAN|4.65||0.635|TWO_SIDED|95.0|-12.5|7.96|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.96|-12.50|0.635
71925153|NCT01590810|143370711|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.18|STANDARD_ERROR_OF_MEAN|5.18||0.143|TWO_SIDED|95.0|-19.58|3.22|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.22|-19.58|0.143
71925154|NCT01590810|143370711|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.51|STANDARD_ERROR_OF_MEAN|4.32||0.004|TWO_SIDED|95.0|-25.01|-6.01|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.01|-25.01|0.004
71925155|NCT01590810|143370712|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.84|STANDARD_ERROR_OF_MEAN|1.42|<|0.0001|TWO_SIDED|95.0|-13.79|-7.89|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.89|-13.79|<0.0001
71925156|NCT01590810|143370712|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.55|STANDARD_ERROR_OF_MEAN|1.26|<|0.0001|TWO_SIDED|95.0|-11.18|-5.91|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.91|-11.18|<0.0001
71925157|NCT01590810|143370712|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.64|STANDARD_ERROR_OF_MEAN|1.34|<|0.0001|TWO_SIDED|95.0|-13.44|-7.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-7.84|-13.44|<0.0001
71925158|NCT01590810|143370712|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.13|STANDARD_ERROR_OF_MEAN|1.36|<|0.0001|TWO_SIDED|95.0|-13.97|-8.29|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-8.29|-13.97|<0.0001
71925159|NCT01590810|143370713|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|1.19||0.547|TWO_SIDED|95.0|-3.19|1.73|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.73|-3.19|0.547
71925160|NCT01590810|143370713|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.53||0.004|TWO_SIDED|95.0|-2.79|-0.62|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.62|-2.79|0.004
71925161|NCT01590810|143370713|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.8|<|0.0001|TWO_SIDED|95.0|-6.23|-2.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.94|-6.23|<0.0001
71925162|NCT01590810|143370713|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.37|STANDARD_ERROR_OF_MEAN|0.78|<|0.001|TWO_SIDED|95.0|-4.98|-1.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.76|-4.98|<0.001
71925163|NCT01590810|143370713|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.92|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-8.24|-3.59|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.59|-8.24|<0.0001
71925164|NCT01590810|143370714|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.43|STANDARD_ERROR_OF_MEAN|1.33||0.017|TWO_SIDED|95.0|-6.19|-0.67|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.67|-6.19|0.017
71925165|NCT01590810|143370714|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.64|STANDARD_ERROR_OF_MEAN|1.35|<|0.001|TWO_SIDED|95.0|-8.43|-2.84|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.84|-8.43|<0.001
71925166|NCT01590810|143370714|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.99|STANDARD_ERROR_OF_MEAN|1.91||0.005|TWO_SIDED|95.0|-9.94|-2.04|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.04|-9.94|0.005
71925167|NCT01590810|143370714|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.33|STANDARD_ERROR_OF_MEAN|1.73|<|0.001|TWO_SIDED|95.0|-10.9|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.76|-10.90|<0.001
71925168|NCT01590810|143370714|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.22|STANDARD_ERROR_OF_MEAN|1.22|<|0.001|TWO_SIDED|95.0|-7.76|-2.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.69|-7.76|<0.001
71925169|NCT01590810|143370715|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.93|STANDARD_ERROR_OF_MEAN|6.52||0.311|TWO_SIDED|95.0|-21.27|7.42|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.42|-21.27|0.311
71925170|NCT01590810|143370715|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.87|STANDARD_ERROR_OF_MEAN|6.62||0.078|TWO_SIDED|95.0|-27.44|1.69|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||1.69|-27.44|0.078
71925171|NCT01590810|143370715|SUPERIORITY_OR_OTHER||LS Mean Difference|-16.03|STANDARD_ERROR_OF_MEAN|6.29||0.027|TWO_SIDED|95.0|-29.87|-2.19|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.19|-29.87|0.027
71925172|NCT01590810|143370716|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.77|STANDARD_ERROR_OF_MEAN|1.5|<|0.0001|TWO_SIDED|95.0|-12.9|-6.65|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.65|-12.90|<0.0001
71925173|NCT01590810|143370716|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.19|STANDARD_ERROR_OF_MEAN|2.1||0.003|TWO_SIDED|95.0|-11.57|-2.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.81|-11.57|0.003
71925174|NCT01590810|143370716|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.19|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-12.4|-3.98|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.98|-12.40|0.001
71925175|NCT01590810|143370716|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.47|STANDARD_ERROR_OF_MEAN|2.02||0.001|TWO_SIDED|95.0|-11.69|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.25|-11.69|0.001
71925176|NCT01590810|143370717|SUPERIORITY_OR_OTHER||LS Mean Difference|0.31|STANDARD_ERROR_OF_MEAN|1.04||0.765|TWO_SIDED|95.0|-1.82|2.45|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||2.45|-1.82|0.765
71925177|NCT01590810|143370717|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|0.56||0.023|TWO_SIDED|95.0|-2.49|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.20|-2.49|0.023
71925178|NCT01590810|143370717|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|-9.18|-4.36|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.36|-9.18|<0.0001
71925179|NCT01590810|143370717|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.45|STANDARD_ERROR_OF_MEAN|1.95||0.01|TWO_SIDED|95.0|-9.46|-1.44|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-1.44|-9.46|0.010
71925180|NCT01590810|143370717|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.61|STANDARD_ERROR_OF_MEAN|1.3|<|0.0001|TWO_SIDED|95.0|-11.28|-5.94|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.94|-11.28|<0.0001
71925181|NCT01590810|143370718|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.02|STANDARD_ERROR_OF_MEAN|1.39||0.16|TWO_SIDED|95.0|-4.89|0.86|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||0.86|-4.89|0.160
71925182|NCT01590810|143370718|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.32|STANDARD_ERROR_OF_MEAN|1.97||0.039|TWO_SIDED|95.0|-8.4|-0.24|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-0.24|-8.40|0.039
71925183|NCT01590810|143370718|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.75|STANDARD_ERROR_OF_MEAN|2.34||0.003|TWO_SIDED|95.0|-12.58|-2.92|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-2.92|-12.58|0.003
71925184|NCT01590810|143370718|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.79|STANDARD_ERROR_OF_MEAN|2.27|<|0.001|TWO_SIDED|95.0|-14.49|-5.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.09|-14.49|<0.001
71925185|NCT01590810|143370718|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.31|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-11.3|-5.31|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.31|-11.30|<0.0001
71925186|NCT01590810|143370719|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.72|STANDARD_ERROR_OF_MEAN|4.0||0.675|TWO_SIDED|95.0|-10.54|7.09|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||7.09|-10.54|0.675
71925187|NCT01590810|143370719|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.76|STANDARD_ERROR_OF_MEAN|4.64||0.174|TWO_SIDED|95.0|-16.98|3.46|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||3.46|-16.98|0.174
71925188|NCT01590810|143370719|SUPERIORITY_OR_OTHER||LS Mean Difference|-13.68|STANDARD_ERROR_OF_MEAN|4.03||0.006|TWO_SIDED|95.0|-22.55|-4.81|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-4.81|-22.55|0.006
71925189|NCT01590810|143370720|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.12|STANDARD_ERROR_OF_MEAN|1.49|<|0.0001|TWO_SIDED|95.0|-12.22|-6.03|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.03|-12.22|<0.0001
71925190|NCT01590810|143370720|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.86|STANDARD_ERROR_OF_MEAN|1.38|<|0.0001|TWO_SIDED|95.0|-9.73|-3.99|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-3.99|-9.73|<0.0001
71925191|NCT01590810|143370720|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.57|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|-11.51|-5.64|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-5.64|-11.51|<0.0001
71925192|NCT01590810|143370720|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.52|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|-12.55|-6.5|||Mixed Models Analysis||Difference is MK-8150 dose - placebo|||-6.50|-12.55|<0.0001
71925193|NCT00412360|143370722|SUPERIORITY|||||||0.17||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.||||0.17
71925194|NCT00412360|143370723|SUPERIORITY|||||||0.11||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.||||0.11
71925195|NCT00412360|143370724|SUPERIORITY|||||||0.29||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.||||0.29
71925196|NCT00412360|143370724|SUPERIORITY|||||||0.04||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.||||0.04
71925197|NCT00412360|143370726|SUPERIORITY|||||||0.78||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.78
71925198|NCT00412360|143370726|SUPERIORITY|||||||0.02||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.||||0.02
71689231|NCT01763827|142894281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.78|STANDARD_ERROR_OF_MEAN|1.87|<|0.001|TWO_SIDED|95.0|-58.46|-51.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-51.10|-58.46|<0.001
71925199|NCT00412360|143370727|SUPERIORITY|||||||0.51||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.51
71925200|NCT00412360|143370727|SUPERIORITY|||||||0.05||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.||||0.05
71925201|NCT00412360|143370729|SUPERIORITY|||||||0.12||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.||||0.12
71689232|NCT01763827|142894281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.29|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-43.28|-35.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.31|-43.28|<0.001
71925202|NCT00412360|143370730|SUPERIORITY|||||||0.43||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.||||0.43
71925203|NCT03655951|143370733|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
71925204|NCT03655951|143370734|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
71925205|NCT03655951|143370735|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
71925206|NCT03655951|143370736|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
71925207|NCT03655951|143370737|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.48|||||||Regression, Linear|||||||.48
71925208|NCT03655951|143370738|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
71925209|NCT03655951|143370739|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.87|||||||Regression, Linear|||||||.87
71925210|NCT03655951|143370740|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.8|||||||Regression, Linear|||||||.8
71925211|NCT03655951|143370741|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.32|||||||Regression, Linear|||||||.32
71925212|NCT03655951|143370742|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
71925213|NCT03655951|143370743|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
71925214|NCT03655951|143370744|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
71925215|NCT03655951|143370745|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.42|||||||Regression, Linear|||||||.42
71925216|NCT03655951|143370746|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
71925217|NCT03655951|143370747|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0003|||||||Regression, Linear|||||||.0003
71925218|NCT03655951|143370748|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.97|||||||Regression, Linear|||||||.97
71925219|NCT03655951|143370749|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.08|||||||Regression, Linear|||||||.08
71925220|NCT03655951|143370750|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.7|||||||Regression, Linear|||||||.70
71925221|NCT03655951|143370751|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
71925222|NCT03655951|143370752|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
71925223|NCT03655951|143370753|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.36|||||||Regression, Linear|||||||.36
71925224|NCT03655951|143370754|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.61|||||||Regression, Linear|||||||.61
71925225|NCT03655951|143370755|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.72|||||||Regression, Linear|||||||.72
71925226|NCT03655951|143370756|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.05|||||||Regression, Linear|||||||.05
71925227|NCT03655951|143370757|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
71761099|NCT04672655|143023807|OTHER|||||||0.9032||||||The a priori threshold for statistical significance was \< 0.05.|linear mixed effects models|||A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.||||0.9032
71925228|NCT03655951|143370758|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
71925229|NCT03655951|143370759|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
71925230|NCT03655951|143370760|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
71925231|NCT03655951|143370761|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
71925232|NCT03655951|143370762|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.0001|||||||Regression, Linear|||||||.0001
71925233|NCT03655951|143370763|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.20
71925234|NCT03655951|143370764|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
71761182|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.4|-0.9|<0.0001
71925235|NCT03655951|143370765|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.62|||||||Regression, Linear|||||||.62
71925236|NCT03655951|143370766|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.29|||||||Regression, Linear|||||||.29
71925237|NCT03655951|143370767|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.14|||||||Regression, Linear|||||||.14
71925238|NCT03655951|143370768|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.008|||||||Regression, Linear|||||||.008
71925239|NCT03655951|143370769|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
71925240|NCT03655951|143370770|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.03|||||||Regression, Linear|||||||.03
71925241|NCT03655951|143370771|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing post-intervention scores onto baseline scores and the treatment variables.||||||0.69|||||||Regression, Linear|||||||.69
71925242|NCT03655951|143370772|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.4|||||||Regression, Logistic|||||||.4
71925243|NCT03655951|143370773|EQUIVALENCE|Binary outcomes were assessed with logistic regression.||||||0.02|||||||Regression, Logistic|||||||.02
71925244|NCT03655951|143370774|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.27|||||||Regression, Linear|||||||.27
71925245|NCT03655951|143370775|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.31|||||||Regression, Linear|||||||.31
71925246|NCT03655951|143370776|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.11|||||||Regression, Linear|||||||.11
71925247|NCT03655951|143370777|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.89|||||||Regression, Linear|||||||.89
71925248|NCT03655951|143370778|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.41|||||||Regression, Linear|||||||.41
71925249|NCT03655951|143370779|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.93|||||||Regression, Linear|||||||.93
71925250|NCT03655951|143370780|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.83|||||||Regression, Linear|||||||.83
71925251|NCT03655951|143370781|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.04|||||||Regression, Linear|||||||.04
71925252|NCT03655951|143370782|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.13|||||||Regression, Linear|||||||.13
71925253|NCT03655951|143370783|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.56|||||||Regression, Linear|||||||.56
71925254|NCT03655951|143370784|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.96|||||||Regression, Linear|||||||.96
71925255|NCT03655951|143370785|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.35|||||||Regression, Linear|||||||.35
71925256|NCT03655951|143370786|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.24|||||||Regression, Linear|||||||.24
71925257|NCT03655951|143370787|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.2|||||||Regression, Linear|||||||.2
71925258|NCT03655951|143370788|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.18|||||||Regression, Linear|||||||.18
71925259|NCT03655951|143370789|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.67|||||||Regression, Linear|||To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||.67
71925260|NCT03655951|143370790|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
71761183|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0043|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.1|-0.6|0.0043
71925261|NCT03655951|143370791|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
71925262|NCT03655951|143370792|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.84|||||||Regression, Linear|||||||.84
71925263|NCT03655951|143370793|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
71925264|NCT03655951|143370794|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.65|||||||Regression, Linear|||||||.65
71925265|NCT03655951|143370795|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.09|||||||Regression, Linear|||||||.09
71925266|NCT03655951|143370796|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
71925267|NCT03655951|143370797|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.47|||||||Regression, Linear|||||||.47
71925268|NCT03655951|143370798|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.003|||||||Regression, Linear|||||||.003
71925269|NCT03655951|143370799|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.77|||||||Regression, Linear|||||||.77
71925270|NCT03655951|143370800|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.|||||<|0.001|||||||Regression, Linear|||||||<.001
71925271|NCT03655951|143370801|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.06|||||||Regression, Linear|||||||.06
71925272|NCT03655951|143370802|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.91|||||||Regression, Linear|||||||.91
71925273|NCT03655951|143370803|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.95|||||||Regression, Linear|||||||.95
71925274|NCT03655951|143370804|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.12|||||||Regression, Linear|||||||.12
71925275|NCT03655951|143370805|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
71925276|NCT03655951|143370806|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.57|||||||Regression, Linear|||||||.57
71925277|NCT03655951|143370807|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.98|||||||Regression, Linear|||||||.98
71925278|NCT03655951|143370808|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.07|||||||Regression, Linear|||||||.07
71925279|NCT03655951|143370809|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.02|||||||Regression, Linear|||||||.02
71925280|NCT03655951|143370810|EQUIVALENCE|To examine intervention effects, a residual difference score approach was used to provide an estimate of change from baseline and is assessed by regressing follow-up scores onto baseline scores and the treatment variables.||||||0.15|||||||Regression, Linear|||||||.15
71925281|NCT01790633|143370885|SUPERIORITY_OR_OTHER||||||<|0.001||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.||||<0.001
71925282|NCT01790633|143370886|SUPERIORITY_OR_OTHER|||||||0.7||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P \< 0.05|Chi-squared|||||||0.7
71925283|NCT00333437|143370924|SUPERIORITY_OR_OTHER||Change from Baseline|0.1786|STANDARD_DEVIATION|0.1613||0.026|TWO_SIDED|95.0|0.0294|0.3277||Not adjusted|t-test, 2 sided|||H(0): post-pre FVC (liters) = 0||0.3277|0.0294|0.026
71925284|NCT00333437|143370925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|8.1035||0.3652|TWO_SIDED|95.0|-10.49|4.4945||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre neutrophil count = 0||4.4945|-10.49|0.3652
71925285|NCT00333437|143370925|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.286|STANDARD_DEVIATION|16.358||0.3485|TWO_SIDED|95.0|-21.41|8.8426||significant p\<0.05|t-test, 2 sided|||H(0): post-pre eosinophil count = 0||8.8426|-21.41|0.3485
71925286|NCT00333437|143370927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|264.26|STANDARD_DEVIATION|194.66||0.0115|TWO_SIDED|95.0|84.256|444.32||Significant p\<0.05|t-test, 2 sided|Not adjusted||H(0): post-pre walk distance = 0||444.32|84.256|0.0115
71925287|NCT00333437|143370928|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8643|STANDARD_DEVIATION|1.5013||0.0167|TWO_SIDED|95.0|0.4758|3.2527||significant p\<0.05|t-test, 2 sided|||H(0): Post-pre DLCO = 0||3.2527|0.4758|0.0167
71925288|NCT03022526|143370929|SUPERIORITY|||||||0.7463|||||||t-test, 2 sided|||||||0.7463
71925289|NCT03022526|143370930|SUPERIORITY|||||||0.5764|||||||t-test, 2 sided|||||||0.5764
71925290|NCT03022526|143370931|SUPERIORITY|||||||0.7169|||||||t-test, 2 sided|||||||0.7169
71925291|NCT03022526|143370932|SUPERIORITY|||||||0.4226|||||||t-test, 2 sided|||||||0.4226
71925292|NCT03022526|143370933|SUPERIORITY|||||||0.6873|||||||t-test, 2 sided|||||||0.6873
71925293|NCT03022526|143370934|SUPERIORITY|||||||0.0452|||||||Chi-squared|||||||0.0452
71925294|NCT03022526|143370935|SUPERIORITY|||||||0.0899|||||||Chi-squared|||||||0.0899
71925295|NCT03022526|143370936|SUPERIORITY|||||||0.1265|||||||Chi-squared|||||||0.1265
71925296|NCT03022526|143370937|SUPERIORITY|||||||0.0328|||||||t-test, 2 sided|||||||0.0328
71925297|NCT03022526|143370938|SUPERIORITY|||||||0.6824|||||||t-test, 2 sided|||||||0.6824
71925298|NCT03022526|143370939|SUPERIORITY|||||||0.449|||||||t-test, 2 sided|||||||0.449
71925299|NCT03022526|143370940|SUPERIORITY|||||||0.5996|||||||t-test, 2 sided|||||||0.5996
71925300|NCT03022526|143370941|SUPERIORITY|||||||0.8009|||||||t-test, 2 sided|||||||0.8009
71925301|NCT03022526|143370942|SUPERIORITY|||||||0.5422|||||||t-test, 2 sided|||||||0.5422
71925302|NCT03022526|143370943|SUPERIORITY|||||||0.7374|||||||t-test, 2 sided|||||||0.7374
71925303|NCT00451191|143370947|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0|||||Simon's optimal two-stage design|||Simon's optimal two-stage design was applied to determine whether there was sufficient activity at either of the two dose levels to warrant further investigation. Each patient was considered either a successful or failed response. The response rate or proportion of patients treated successfully was examined in two stages. At both stages, the two dose levels were compared to pre-determined critical cut-off values. Sample size was based on significance level α=0.05 and power 90%.||||<0.05
71925304|NCT01458535|143370953|SUPERIORITY_OR_OTHER|||||||0.157|||||||Cochran-Mantel-Haenszel|||||||0.157
71689233|NCT01763827|142894281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-37.55|STANDARD_ERROR_OF_MEAN|1.88|<|0.001|TWO_SIDED|95.0|-41.24|-33.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-33.86|-41.24|<0.001
71689234|NCT01763827|142894282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.5|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-59.95|-53.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-53.04|-59.95|<0.001
71689235|NCT01763827|142894282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-57.4|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-60.66|-54.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.||-54.14|-60.66|<0.001
71689236|NCT01763827|142894282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.41|STANDARD_ERROR_OF_MEAN|1.76|<|0.001|TWO_SIDED|95.0|-42.87|-35.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-35.94|-42.87|<0.001
71689237|NCT01763827|142894282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.69|STANDARD_ERROR_OF_MEAN|1.66|<|0.001|TWO_SIDED|95.0|-42.97|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.||-36.42|-42.97|<0.001
71925305|NCT01458535|143370953|SUPERIORITY_OR_OTHER|||||||0.999|||||||Cochran-Mantel-Haenszel|||||||0.999
71925306|NCT01458535|143370953|SUPERIORITY_OR_OTHER|||||||0.045|||||||Cochran-Mantel-Haenszel|||||||0.045
71925307|NCT01238861|143370960|SUPERIORITY_OR_OTHER||Rate Ratio|1.09||||0.781|TWO_SIDED|80.0|0.74|1.59|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||1.59|0.74|0.781
71925308|NCT01238861|143370960|SUPERIORITY_OR_OTHER||Rate Ratio|0.64||||0.173|TWO_SIDED|80.0|0.42|0.97|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.97|0.42|0.173
71925309|NCT01238861|143370960|SUPERIORITY_OR_OTHER||Rate ratio|0.59||||0.096|TWO_SIDED|80.0|0.4|0.89|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.|||0.89|0.40|0.096
71925310|NCT01238861|143370965|SUPERIORITY_OR_OTHER|||||||0.125|||||||ANCOVA|P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.125
71925311|NCT01238861|143370965|SUPERIORITY_OR_OTHER|||||||0.074|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.074
71925312|NCT01238861|143370965|SUPERIORITY_OR_OTHER|||||||0.057|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.057
71925313|NCT01238861|143370965|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.010
71925314|NCT01238861|143370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.182||||0.131|TWO_SIDED|80.0|-0.336|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.336|0.131
71925315|NCT01238861|143370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.173||||0.126|TWO_SIDED|80.0|-0.317|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.028|-0.317|0.126
71925316|NCT01238861|143370967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.097|TWO_SIDED|80.0|-0.247|-0.032|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||-0.032|-0.247|0.097
71925317|NCT01238861|143370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.174||||0.642|TWO_SIDED|80.0|-0.654|0.306|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.306|-0.654|0.642
71925318|NCT01238861|143370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.111||||0.824|TWO_SIDED|80.0|-0.533|0.756|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.756|-0.533|0.824
71925319|NCT01238861|143370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029||||0.91|TWO_SIDED|80.0|-0.297|0.355|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.||0.355|-0.297|0.910
71689238|NCT01763827|142894283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-79.6|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-85.0|-74.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.2|-85.0|<0.001
71925320|NCT01238861|143370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.004||||0.992|TWO_SIDED|80.0|-0.602|0.593|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.593|-0.602|0.992
71925321|NCT01238861|143370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.337||||0.624|TWO_SIDED|80.0|-0.548|1.222|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||1.222|-0.548|0.624
71925322|NCT01238861|143370968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.645|TWO_SIDED|80.0|-0.267|0.567|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.||0.567|-0.267|0.645
71925323|NCT01238861|143370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157||||0.014|TWO_SIDED|80.0|0.076|0.237|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.237|0.076|0.014
71925324|NCT01238861|143370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184||||0.004|TWO_SIDED|80.0|0.102|0.266|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.266|0.102|0.004
71925325|NCT01238861|143370969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091||||0.026|TWO_SIDED|80.0|0.039|0.143|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.143|0.039|0.026
71925326|NCT01238861|143370970|SUPERIORITY_OR_OTHER|||||||0.384|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.384
71925327|NCT01238861|143370970|SUPERIORITY_OR_OTHER|||||||0.092|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.092
71925328|NCT01238861|143370970|SUPERIORITY_OR_OTHER|||||||0.134|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.134
71925329|NCT01238861|143370970|SUPERIORITY_OR_OTHER|||||||0.129|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.129
71925330|NCT01238861|143370972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.404||||0.069|TWO_SIDED|80.0|0.121|0.687|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.687|0.121|0.069
71925331|NCT01238861|143370972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.462||||0.049|TWO_SIDED|80.0|0.163|0.761|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.761|0.163|0.049
71925332|NCT01238861|143370972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238||||0.168|TWO_SIDED|80.0|0.017|0.459|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.459|0.017|0.168
71925333|NCT01238861|143370973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.51|TWO_SIDED|80.0|-0.058|0.019|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.019|-0.058|0.510
71925334|NCT01238861|143370973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.041||||0.113|TWO_SIDED|80.0|0.008|0.074|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.074|0.008|0.113
71925335|NCT01238861|143370973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011||||0.599|TWO_SIDED|80.0|-0.016|0.038|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||0.038|-0.016|0.599
71925336|NCT01238861|143370974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.373||||0.871|TWO_SIDED|80.0|-3.333|2.586|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||2.586|-3.333|0.871
71925337|NCT01238861|143370974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.857||||0.227|TWO_SIDED|80.0|-0.175|5.889|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||5.889|-0.175|0.227
71925338|NCT01238861|143370974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.139||||0.503|TWO_SIDED|80.0|-1.041|3.319|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||3.319|-1.041|0.503
71925339|NCT01238861|143370975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.907||||0.55|TWO_SIDED|80.0|-4.483|12.297|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||12.297|-4.483|0.550
71925340|NCT01238861|143370975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.659||||0.215|TWO_SIDED|80.0|-0.262|15.579|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||15.579|-0.262|0.215
71925341|NCT01238861|143370975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.54||||0.413|TWO_SIDED|80.0|-2.006|9.086|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||9.086|-2.006|0.413
71925342|NCT01238861|143370976|SUPERIORITY_OR_OTHER|||||||0.896|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.896
71925343|NCT01238861|143370976|SUPERIORITY_OR_OTHER|||||||0.944|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.944
71925344|NCT01238861|143370976|SUPERIORITY_OR_OTHER|||||||0.667|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||||||0.667
71925345|NCT04602078|143371007|SUPERIORITY|||||||0.444|||||||Log Rank|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.444
71925346|NCT04602078|143371008|SUPERIORITY|||||||0.414|||||||Chi-squared|||Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative||||0.414
71925347|NCT02706327|143371010|OTHER||||||<|0.001||||||A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.|Kruskal-Wallis|Effect sizes (Cohen's d) were calculated for significant differences.||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.||||<0.001
71925348|NCT02706327|143371011|OTHER|||||||0.547|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.547
71925349|NCT02706327|143371012|OTHER|||||||0.895|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.895
71925350|NCT02706327|143371013|OTHER|||||||0.842|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.842
71925351|NCT02706327|143371014|OTHER|||||||0.848|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.||||0.848
71925352|NCT06104423|143371059|SUPERIORITY||Mean difference pre vs post treatment|-19.2|STANDARD_DEVIATION|8.62|<|0.001|TWO_SIDED|95.0|-26.0|-14.0|||paired t-test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting systolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 5 (Week 12, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-14.0|-26.0|< 0.001
71925353|NCT03417245|143371060|SUPERIORITY||ABR ratio|0.101|||<|0.0001|TWO_SIDED|95.0|0.064|0.159||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression mode|||||0.159|0.064|<0.0001
71925354|NCT03417245|143371062|SUPERIORITY||ABR ratio|0.13|||<|0.0001|TWO_SIDED|95.0|0.09|0.188||P-value derived from NB regression model during TP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.188|0.090|<0.0001
71925355|NCT03417245|143371064|SUPERIORITY||ABR ratio|0.083|||<|0.0001|TWO_SIDED|95.0|0.049|0.141||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.141|0.049|<0.0001
71925356|NCT03417245|143371066|SUPERIORITY||ABR ratio|0.097|||<|0.0001|TWO_SIDED|95.0|0.059|0.161||P-value derived from NB regression model during EP, with treatment arm, number of bleeds in 6 months prior to study (\<=10, \>10) and hemophilia type (A vs B) as fixed effects. Significance threshold was at 0.05.|Negative binomial regression model|||||0.161|0.059|<0.0001
71925357|NCT03417245|143371068|SUPERIORITY||Least Square (LS) Mean difference|-19.75|||<|0.0001|TWO_SIDED|95.0|-27.0|-12.5||Analysis of Covariance (ANCOVA) model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-12.50|-27.00|<0.0001
71925358|NCT03417245|143371069|SUPERIORITY||LS Mean difference|-7.07|||=|0.0011|TWO_SIDED|95.0|-11.23|-2.9||ANCOVA model included treatment arm, number of bleeds in 6 months prior to study (\<=10,\>10) and hemophilia type (A vs B) as fixed effects, Baseline score as covariate. Significance threshold was at 0.05.|ANCOVA|||||-2.90|-11.23|=0.0011
71925359|NCT02067728|143371137|SUPERIORITY_OR_OTHER|||||||0.0029|TWO_SIDED||||||Chi-squared|||||||0.0029
71925360|NCT02067728|143371138|SUPERIORITY_OR_OTHER|||||||0.3875|TWO_SIDED||||||t-test, 2 sided|||||||0.3875
71925361|NCT02067728|143371139|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26|STANDARD_DEVIATION|0.42|<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71925362|NCT02067728|143371140|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Chi-squared|||||||>0.05
71925363|NCT02067728|143371141|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Chi-squared|||||||1.000
71925364|NCT02067728|143371142|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|3.3|||<|0.0001|TWO_SIDED|95.0|2.2|4.9|||Chi-squared|||||4.9|2.2|<0.0001
71925365|NCT02067728|143371143|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.9|||<|0.0001|TWO_SIDED|95.0|2.0|4.5|||Chi-squared|||||4.5|2.0|<0.0001
71925366|NCT02067728|143371146|SUPERIORITY_OR_OTHER|||||||0.4835|TWO_SIDED||||||t-test, 2 sided|||||||0.4835
71925367|NCT02067728|143371147|SUPERIORITY_OR_OTHER|||||||0.588|TWO_SIDED||||||t-test, 2 sided|||||||0.5880
71925368|NCT00234533|143371191|OTHER|An one-way Analysis of Covariance (ANOVA) was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.9|||||TWO_SIDED|95.0|0.88|0.92|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An Intra-class Correlation Coefficient (ICC) for the evening series (defined as 12:00 to 24:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.92|0.88|
71925369|NCT00234533|143371191|OTHER|An one-way ANOVA was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.92|||||TWO_SIDED|95.0|0.9|0.93|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An ICC for the morning series (defined as 06:00 to 12:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.||0.93|0.90|
71925370|NCT00234533|143371192|OTHER||Fisher's F statistic (F) value|1.79|||||TWO_SIDED|||||||||Analysis of the weekly timing effect (Week 21 versus Week 22 versus Week 23) on the IGF-I value as measured by capillary blood spot method.|For the effect of the weekly timing on the IGF-I levels; F value = 1.79 and the significance probability value, PR\>F = 0.1678.|||
71925371|NCT00234533|143371192|OTHER||F value|1.06|||||TWO_SIDED|||||||||Analysis of the daily timing effect (morning versus evening) on the IGF-I value as measured by capillary blood spot method.|For the effect of the daily timing on the IGF-I levels; F value = 1.06 and the significance probability value, PR\>F = 0.3035|||
71925372|NCT00234533|143371193|OTHER||F value|83.97|||||TWO_SIDED|||||||||Analysis of the effect of the patient's sex (male versus female) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's sex on the IGF-I levels; F value = 83.97 and the significance probability value, PR\>F = \<0.0001.|||
71925373|NCT00234533|143371193|OTHER||F value|68.35|||||TWO_SIDED|||||||||Analysis of the effect of the patient's pubertal status (pubertal versus prepubertal) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's pubertal status on the IGF-I levels; F value = 68.35 and the significance probability value, PR\>F = \<0.0001.|||
71925374|NCT00234533|143371194|OTHER||F value|10.73|||||TWO_SIDED|||||||||Analysis of the disease condition (GHD versus TS) on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 10.73 and the significance probability value, PR\>F = 0.0012.|||
71925375|NCT00234533|143371194|OTHER||F value|2.2|||||TWO_SIDED|||||||||Analysis of the country cluster on the IGF-I value as measured by capillary blood spot method.|For the effect of the country cluster on the IGF-I levels; F value = 2.20 and the significance probability value, PR\>F = 0.0701.|||
71925376|NCT00234533|143371195|OTHER||F value|3.65|||||TWO_SIDED|||||||||Analysis of the time of the year on the IGF-I value as measured by capillary blood spot method.|For the effect of the time of the year on the IGF-I levels; F value = 3.65 and the significance probability value, PR\>F = 0.0139.|||
71925377|NCT00234533|143371195|OTHER||F value|7.38|||||TWO_SIDED|||||||||Analysis of the effect of the calculated age at enrolment on the IGF-I value as measured by capillary blood spot method.|For the effect of the calculated age at enrolment on the IGF-I levels; F value = 7.38 and the significance probability value, PR\>F = 0.0073.|||
71925378|NCT00234533|143371195|OTHER||F value|3.86|||||TWO_SIDED|||||||||Analysis of the effect of the disease condition on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 3.86 and the significance probability value, PR\>F = 0.0511|||
71925379|NCT00234533|143371196|OTHER||Mean difference|-164.79|STANDARD_ERROR_OF_MEAN|159.28|||TWO_SIDED|95.0|-483.35|-153.77||||||The Bland and Altman method was used to compare the results of each of the three simultaneous random capillary and serum measurements were compared. The difference between the capillary blood spot method and the serum IGF-I measurements is presented||-153.77|-483.35|
71925380|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|3.04||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.32
71925381|NCT01484691|143371207|SUPERIORITY||Mean Difference (Final Values)|1.91||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.38
71925382|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|0.47||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.83
71925383|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|1.27||||0.42|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.42
71925384|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|2.55||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.32
71925385|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|0.68||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.83
71925386|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|1.94||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.38
71925387|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|2.77||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.38
71925388|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|3.38||||0.32|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.32
71925389|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.99
71925390|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|1.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.38
71925391|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|1.57||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.38
71689239|NCT01763827|142894283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-81.9|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-87.0|-76.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-76.9|-87.0|<0.001
71689240|NCT01763827|142894283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.001|TWO_SIDED|95.0|-60.7|-49.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-49.9|-60.7|<0.001
71689241|NCT01763827|142894283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-56.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.001|TWO_SIDED|95.0|-61.1|-51.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-51.0|-61.1|<0.001
71689242|NCT01763827|142894284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-80.4|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-86.4|-74.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-74.3|-86.4|<0.001
71689243|NCT01763827|142894284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-77.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.001|TWO_SIDED|95.0|-83.4|-72.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-72.2|-83.4|<0.001
71689244|NCT01763827|142894284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-55.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.001|TWO_SIDED|95.0|-61.1|-49.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-49.0|-61.1|<0.001
71925392|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|0.52||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.83
71925393|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|0.81||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.83
71925394|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|1.39||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.38
71925395|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|-0.92||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.38
71689245|NCT01763827|142894284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.001|TWO_SIDED|95.0|-58.5|-47.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference|||-47.3|-58.5|<0.001
71689246|NCT01763827|142894285|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|73.6|||<|0.001|TWO_SIDED|95.0|64.4|80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||80.2|64.4|<0.001
71689247|NCT01763827|142894285|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.3|||<|0.001|TWO_SIDED|95.0|62.2|78.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.0|62.2|<0.001
71925396|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|0.55||||0.83|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.83
71689248|NCT01763827|142894285|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|72.2|||<|0.001|TWO_SIDED|95.0|62.4|78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.9|62.4|<0.001
71925397|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|-1.12||||0.3|TWO_SIDED||||||t-test, 2 sided|||mir1915||||0.30
71925398|NCT01484691|143371207|SUPERIORITY||Mean Difference (Net)|-1.35||||0.38|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.38
71689249|NCT01763827|142894285|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|68.6|||<|0.001|TWO_SIDED|95.0|58.3|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||75.5|58.3|<0.001
71925399|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|4.53||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1||||0.26
71925400|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|4.52||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir107||||0.26
71925401|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|3.57||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir128||||0.26
71689250|NCT01763827|142894286|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.2|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.2|<0.001
71689251|NCT01763827|142894286|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|65.4|||<|0.001|TWO_SIDED|95.0|55.6|72.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||72.9|55.6|<0.001
71689252|NCT01763827|142894286|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|71.5|||<|0.001|TWO_SIDED|95.0|61.3|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||78.4|61.3|<0.001
71925402|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|-0.58||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir141||||0.87
71925403|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|4.57||||0.29|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir148b||||0.29
71925404|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|1.56||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir181b||||0.75
71925405|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|2.9||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir185||||0.36
71925406|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|-0.36||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir194||||0.89
71925407|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|2.48||||0.48|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir19a||||0.48
71925408|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|0.75||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir200a||||0.87
71925409|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|2.78||||0.53|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir22||||0.53
71925410|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|1.91||||0.57|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir223||||0.57
71925411|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|4.27||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir23a||||0.26
71925412|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|1.66||||0.75|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir26a||||0.75
71925413|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|-0.91||||0.89|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir320b||||0.89
71925414|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|3.32||||0.26|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir598||||0.26
71925415|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|-0.99||||0.87|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir720||||0.87
71925416|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|-0.75||||0.74|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1915||||0.74
71925417|NCT01484691|143371208|SUPERIORITY||Mean Difference (Net)|3.77||||0.36|TWO_SIDED|||||This p value is adjusted for multiple comparisons using the false discovery rate (FDR) approach and a p value \<0.05 is taken for significance.|t-test, 2 sided|||mir1978||||0.36
71925418|NCT00736840|143371225|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Provided above|Sensitivity|0.74|STANDARD_ERROR_OF_MEAN|0.0363||0.0924|TWO_SIDED|95.0|0.6607|0.8809|||Exact binomial test|||The null hypothesis was sensitivity lower than 0.8. We assumed a sensitivity of 0.89 and required a power of 90% to test the hypothesis at a 5% level of significance, and calculated that 173 cirrhotic and 241 non-cirrhotic subjects were needed (for a one-sample binomial test of outcome versus constant).||0.8809|0.6607|0.0924
71925419|NCT00736840|143371226|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sample size was calculated to enable the testing of both study hypotheses (together) with at least 80% power. Our best estimate of sensitivity of the HIS diagnosis in the population, was 0.9 and its specificity 0.79. Requiring a power of 90% for each of the hypotheses and a 5% level of significance, to test the null hypotheses 173 cirrhotic and 241 non-cirrhotic subjects were needed.Therefore a total of at least 414 subjects were required.|AUC ROC|0.785|STANDARD_ERROR_OF_MEAN|0.0485|<|0.0001|TWO_SIDED|95.0|0.737|0.834|||Regression, Logistic|||||0.834|0.737|<0.0001
71689253|NCT01763827|142894286|SUPERIORITY_OR_OTHER_LEGACY||Treatment Difference|64.0|||<|0.001|TWO_SIDED|95.0|53.5|71.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.||||71.6|53.5|<0.001
71689254|NCT01763827|142894287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.81|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-52.01|-45.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.61|-52.01|<0.001
71689255|NCT01763827|142894287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-53.28|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-56.23|-50.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.33|-56.23|<0.001
71925420|NCT01314261|143371231|SUPERIORITY_OR_OTHER|||||||0.336|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.336
71925421|NCT01314261|143371231|SUPERIORITY_OR_OTHER|||||||0.171|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.171
71925422|NCT01314261|143371231|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.||||0.030
71925423|NCT01314261|143371232|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.102
71925424|NCT01314261|143371232|SUPERIORITY_OR_OTHER|||||||0.362|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.362
71925425|NCT01314261|143371232|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.079
71925426|NCT01314261|143371236|SUPERIORITY_OR_OTHER|||||||0.083|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.083
71925427|NCT01314261|143371236|SUPERIORITY_OR_OTHER|||||||0.515|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.515
71925428|NCT01314261|143371236|SUPERIORITY_OR_OTHER|||||||0.221|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or \> median).||||||0.221
71925429|NCT01314261|143371237|SUPERIORITY_OR_OTHER|||||||0.155|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.155
71925430|NCT01314261|143371237|SUPERIORITY_OR_OTHER|||||||0.214|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.214
71925431|NCT01314261|143371237|SUPERIORITY_OR_OTHER|||||||0.231|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.231
71689256|NCT01763827|142894287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.58|STANDARD_ERROR_OF_MEAN|1.63|<|0.001|TWO_SIDED|95.0|-38.79|-32.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.38|-38.79|<0.001
71689257|NCT01763827|142894287|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.49|STANDARD_ERROR_OF_MEAN|1.5|<|0.001|TWO_SIDED|95.0|-38.44|-32.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.53|-38.44|<0.001
71925432|NCT01314261|143371238|SUPERIORITY_OR_OTHER|||||||0.127|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.127
71925433|NCT01314261|143371238|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.328
71925434|NCT01314261|143371238|SUPERIORITY_OR_OTHER|||||||0.166|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.166
71925435|NCT01314261|143371239|SUPERIORITY_OR_OTHER|||||||0.007|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.007
71925436|NCT01314261|143371239|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.029
71925437|NCT01314261|143371239|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank|||||||0.105
71925438|NCT01314261|143371242|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.028
71925439|NCT01314261|143371242|SUPERIORITY_OR_OTHER|||||||0.051|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.051
71925440|NCT01314261|143371242|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||||||0.021
71925441|NCT00422227|143371258|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||||||<0.001
71925442|NCT00422227|143371259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 20||||<0.001
71925443|NCT00422227|143371259|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||ACR 50||||<0.001
71925444|NCT00422227|143371259|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Fisher Exact|||ACR 70||||0.009
71925445|NCT00422227|143371260|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||Low Disease (DAS28 \<3.2)||||<0.001
71925446|NCT00422227|143371260|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Fisher Exact|||Remission (DAS28 \<2.6)||||0.069
71925447|NCT00422227|143371261|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71925448|NCT00422227|143371262|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71925449|NCT00422227|143371263|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||≥0.6||||0.003
71925450|NCT00422227|143371263|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||≥1.2||||0.001
71925451|NCT00422227|143371264|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||ANCOVA|||Painful Joints at Week 16||||0.014
71925452|NCT00422227|143371264|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Swollen Joints at Week 16||||<0.001
71925453|NCT00422227|143371265|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Physician Global Assessment Week 16||||<0.001
71925454|NCT00422227|143371265|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Subject Global Assessment Week 16||||<0.001
71925455|NCT00422227|143371266|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Week 16||||<0.001
71925456|NCT00422227|143371267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||General Health Week 16||||<0.001
71925457|NCT00422227|143371267|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||Pain Week 16||||<0.001
71925458|NCT00422227|143371267|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||Fatigue Week 16||||0.001
71925459|NCT00157157|143371280|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.95||||||95.0|1.29|19.06||||||||19.06|1.29|
71925460|NCT00157157|143371281|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||||95.0|1.18|14.82||||||||14.82|1.18|
71925461|NCT00157157|143371282|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.5||||||95.0|1.05|19.25||||||||19.25|1.05|
71925462|NCT01018680|143371283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||Using a 1:1 ratio of allocation to treatment, a 2-tailed 0.05 level of significance and 80% power, 253 participants per arm had been estimated to be adequate to assess an effect size of 0.25, based on a 2-sample Student's t-test. This derived estimate was increased slightly to 261 participants per arm to account for extremely early discontinuation that would have led to exclusion from the efficacy analysis in a small number of participants (approximately 3%).||||<0.001
71925463|NCT01018680|143371284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59|||<|0.001||95.0||||First gated secondary outcome measure. Gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 secondary outcomes with sequential comparisons of treatments until outcome failed to be significant (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925464|NCT01018680|143371285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.84|||<|0.001||95.0||||WOMAC Physical Disability Score p-value. Second gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 2 secondary outcomes with sequential treatment comparisons until outcome failed significance (p\>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71689258|NCT01763827|142894288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.81|STANDARD_ERROR_OF_MEAN|1.79|<|0.001|TWO_SIDED|95.0|-53.34|-46.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-46.27|-53.34|<0.001
71689259|NCT01763827|142894288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-51.19|STANDARD_ERROR_OF_MEAN|1.67|<|0.001|TWO_SIDED|95.0|-54.49|-47.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.90|-54.49|<0.001
71925465|NCT01018680|143371285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||<|0.001||95.0||||This is the p-value for the WOMAC Pain Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925466|NCT01018680|143371285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.004||95.0||||This is the p-value for WOMAC Stiffness Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.004
71925467|NCT01018680|143371286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|||<|0.001||95.0||||This is the p-value for Night Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925468|NCT01018680|143371286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03|||<|0.001||95.0||||This is the p-value for Worst Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925469|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08|||<|0.001||95.0||||This is the p-value for BPI-S for Worst Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925470|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|||<|0.001||95.0||||This is the p-value for BPI-S for Least Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925471|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-S for Average Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925472|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71|||<|0.001||95.0||||This is the p-value for BPI-S for Pain Right Now. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925473|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|||<|0.001||95.0||||This is the p-value for BPI-I for General Activity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925474|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72|||<|0.001||95.0||||This is the p-value for BPI-I for Mood. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925475|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-I for Walking Ability. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925476|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85|||<|0.001||95.0||||This is the p-value for BPI-I for Normal Work. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925477|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|||<|0.001||95.0||||This is the p-value for BPI-I for Relations with Others. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925478|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|||<|0.001||95.0||||This is the p-value for BPI-I for Sleep. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925479|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||<|0.001||95.0||||This is the p-value for BPI-I for Enjoyment of Life. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925480|NCT01018680|143371287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|||<|0.001||95.0||||This is the p-value for BPI-I for Mean Interference Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925481|NCT01018680|143371288|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925482|NCT01018680|143371289|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||<0.001
71925483|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.449||95.0||||This is the p-value for the BPOMS Total Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.449
71925484|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.265||95.0||||This is the p-value for the BPOMS Tension-Anxiety Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.265
71925485|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.18||95.0||||This is the p-value for the BPOMS Depression-Dejection Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.180
71925486|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.041||95.0||||This is the p-value for the BPOMS Anger-Hostility Score. 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.041
71925487|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.356||95.0||||This is the p-value for the BPOMS Vigor-Activity Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.356
71925488|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.862||95.0||||This is the p-value for the BPOMS Fatigue-Inertia Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.862
71925489|NCT01018680|143371290|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.883||95.0||||This is the p-value for the BPOMS Confusion-Bewilderment Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.883
71925490|NCT01018680|143371291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.0||||0.083||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||||||0.083
71925491|NCT01018680|143371292|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
71925492|NCT01018680|143371293|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
71925493|NCT01018680|143371293|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||<0.001
71925494|NCT01018680|143371294|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 30% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
71925495|NCT01018680|143371294|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 50% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact|||||||<0.001
71925496|NCT01018680|143371295|SUPERIORITY_OR_OTHER|||||||0.012||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.012
71925497|NCT01018680|143371296|SUPERIORITY_OR_OTHER|||||||0.724||95.0||||This is the p-value for PCS Weight Gain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.724
71925498|NCT01018680|143371296|SUPERIORITY_OR_OTHER|||||||0.106||95.0||||This is the p-value for PCS Weight Loss. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.106
71925499|NCT01018680|143371297|SUPERIORITY_OR_OTHER|||||||0.031||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.031
71925500|NCT01018680|143371298|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||This is the p-value for Diastolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.063
71925501|NCT01018680|143371298|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||This is the p-value for Systolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.018
71925502|NCT01018680|143371299|SUPERIORITY_OR_OTHER|||||||0.249||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact|||||||0.249
71925503|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||This is the p-value for outpatient group visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.241
71925504|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.087||95.0||||This is the p-value for outpatient individual visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.087
71925505|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.414||95.0||||This is the p-value for emergency room visits for non-psychiatric illness. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.414
71925506|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.332||95.0||||This is the p-value for outpatient visits to other physicians. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.332
71925507|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.183||95.0||||This is the p-value for the average number of hours worked for pay per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.183
71689260|NCT01763827|142894288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.23|STANDARD_ERROR_OF_MEAN|1.78|<|0.001|TWO_SIDED|95.0|-38.74|-31.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.71|-38.74|<0.001
71689261|NCT01763827|142894288|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.21|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-36.51|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.90|-36.51|<0.001
71925508|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.666||95.0||||This is the p-value for how long the participant has had this job. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.666
71925509|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.89||95.0||||This is the p-value for the average number of hours of volunteer work per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.890
71925510|NCT01018680|143371300|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||This is the p-value for psychiatric visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared|||||||0.413
71925511|NCT02383966|143371304|OTHER||Hazard Ratio (HR)|0.566|||||TWO_SIDED|95.0|0.4|0.803||||||||0.803|0.400|
71925512|NCT02383966|143371305|OTHER||Hazard Ratio (HR)|0.568|||||TWO_SIDED|95.0|0.406|0.795||||||||0.795|0.406|
71925513|NCT02383966|143371306|OTHER||Hazard Ratio (HR)|0.705|||||TWO_SIDED|95.0|0.502|0.991||||||||0.991|0.502|
71925514|NCT02383966|143371307|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED|95.0|1.52|5.45||||||||5.45|1.52|
71925515|NCT02383966|143371308|OTHER||Odds Ratio (OR)|2.14|||||TWO_SIDED|95.0|1.15|3.95||||||||3.95|1.15|
71925516|NCT02163759|143371311|SUPERIORITY||Difference in Remission Rates|12.3||||0.0173|TWO_SIDED|95.0|1.59|20.6||The threshold for statistical significance was a p-value \<0.05.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|The null hypothesis (H0): the percentage of participants achieving remission at Week 10 was the same in both the placebo and etrolizumab arms. The alternative hypothesis (H1): the percentage of participants achieving remission at Week 10 was not the same in the placebo and etrolizumab arms.||20.60|1.59|0.0173
71925517|NCT02163759|143371312|SUPERIORITY||Difference in Remission Rates|-3.1||||0.5055|TWO_SIDED|95.0|-12.61|6.37||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||6.37|-12.61|0.5055
71925518|NCT02163759|143371313|SUPERIORITY||Difference in Remission Rates|-5.0||||1|TWO_SIDED|95.0|-11.66|1.75||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||1.75|-11.66|1
71925519|NCT02163759|143371314|SUPERIORITY||Difference in Response Rates|6.9||||0.4434|TWO_SIDED|95.0|-7.03|20.62||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||20.62|-7.03|0.4434
71925520|NCT02163759|143371314|SUPERIORITY||Difference in Response Rates|4.8||||0.4122|TWO_SIDED|95.0|-6.72|16.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||16.07|-6.72|0.4122
71925521|NCT02163759|143371315|SUPERIORITY||Difference in Response Rates|1.2||||1|TWO_SIDED|95.0|-6.98|9.26||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.26|-6.98|1
71925522|NCT02163759|143371316|SUPERIORITY||Difference in Response Rates|17.9||||0.0173|TWO_SIDED|95.0|4.49|29.5||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 1 of the testing procedure; please refer to the statistical analysis plan for details.||29.50|4.49|0.0173
71925523|NCT02163759|143371316|SUPERIORITY||Difference in Response Rates|7.4||||0.1886|TWO_SIDED|95.0|-3.77|18.32||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||18.32|-3.77|0.1886
71925524|NCT02163759|143371317|SUPERIORITY||Difference in Response Rates|1.9||||1|TWO_SIDED|95.0|-6.04|9.88||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in response rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 3 of the testing procedure; please refer to the statistical analysis plan for details.||9.88|-6.04|1
71689262|NCT01763827|142894289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.09|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-50.67|-43.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-43.51|-50.67|<0.001
71925525|NCT02163759|143371318|SUPERIORITY||Difference in Remission Rates|13.8||||0.1347|TWO_SIDED|95.0|2.97|22.15||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||22.15|2.97|0.1347
71925526|NCT02163759|143371318|SUPERIORITY||Difference in Remission Rates|0.5||||0.9138|TWO_SIDED|95.0|-8.95|9.92||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||9.92|-8.95|0.9138
71925527|NCT02163759|143371319|SUPERIORITY||Difference in Remission Rates|-3.5||||1|TWO_SIDED|95.0|-10.27|3.3||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||3.30|-10.27|1
71925528|NCT02163759|143371320|SUPERIORITY||Difference in Remission Rates|26.3||||0.0173|TWO_SIDED|95.0|12.1|37.86||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||37.86|12.10|0.0173
71925529|NCT02163759|143371320|SUPERIORITY||Difference in Remission Rates|13.2||||0.0313|TWO_SIDED|95.0|0.93|24.94||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||24.94|0.93|0.0313
71925530|NCT02163759|143371321|SUPERIORITY||Difference in Remission Rates|-0.3||||1|TWO_SIDED|95.0|-9.13|8.45||p-value has been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||8.45|-9.13|1
71689263|NCT01763827|142894289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-50.93|STANDARD_ERROR_OF_MEAN|1.7|<|0.001|TWO_SIDED|95.0|-54.27|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-47.59|-54.27|<0.001
71925531|NCT02163759|143371322|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
71925532|NCT02163759|143371322|SUPERIORITY|||||||0.3374||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.3374
71925533|NCT02163759|143371323|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and RB score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71925534|NCT02163759|143371324|SUPERIORITY|||||||0.4434||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 2 of the testing procedure; please refer to the statistical analysis plan for details.||||0.4434
71925535|NCT02163759|143371324|SUPERIORITY|||||||0.6367||||||Nominal p-value; it has not been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||||0.6367
71925536|NCT02163759|143371325|SUPERIORITY|||||||1||||||p-value has been adjusted for multiplicity.|Rank ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and SF score at BL.||Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 5 of the testing procedure; please refer to the statistical analysis plan for details.||||1
71925537|NCT02163759|143371326|SUPERIORITY||Mean Difference (Net)|-0.7||||0.3708|TWO_SIDED|95.0|-2.4|0.9||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.9|-2.4|0.3708
71689264|NCT01763827|142894289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.57|STANDARD_ERROR_OF_MEAN|1.82|<|0.001|TWO_SIDED|95.0|-37.15|-29.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.99|-37.15|<0.001
71925538|NCT02163759|143371326|SUPERIORITY||Mean Difference (Net)|-0.5||||0.4477|TWO_SIDED|95.0|-1.8|0.8||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.8|-1.8|0.4477
71689265|NCT01763827|142894289|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.64|STANDARD_ERROR_OF_MEAN|1.71|<|0.001|TWO_SIDED|95.0|-37.99|-31.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.28|-37.99|<0.001
71689266|NCT01763827|142894290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-47.81|STANDARD_ERROR_OF_MEAN|1.91|<|0.001|TWO_SIDED|95.0|-51.56|-44.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.05|-51.56|<0.001
71689267|NCT01763827|142894290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-48.43|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-52.07|-44.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-44.79|-52.07|<0.001
71689268|NCT01763827|142894290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.04|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|-37.78|-30.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.30|-37.78|<0.001
71689269|NCT01763827|142894290|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-32.57|STANDARD_ERROR_OF_MEAN|1.85|<|0.001|TWO_SIDED|95.0|-36.21|-28.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-28.92|-36.21|<0.001
71925539|NCT02163759|143371327|SUPERIORITY||Mean Difference (Net)|-1.0||||1|TWO_SIDED|95.0|-2.1|0.2||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.2|-2.1|1
71925540|NCT02163759|143371327|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-1.2|0.7||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.7|-1.2|1
71925541|NCT02163759|143371328|SUPERIORITY||Mean Difference (Net)|-0.2||||0.6356|TWO_SIDED|95.0|-0.9|0.5||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.5|-0.9|0.6356
71925542|NCT02163759|143371328|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1253|TWO_SIDED|95.0|-1.0|0.1||Nominal p-value; it has not been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||0.1|-1.0|0.1253
71925543|NCT02163759|143371329|SUPERIORITY||Mean Difference (Net)|-0.5||||1|TWO_SIDED|95.0|-1.0|0.0||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 4 of the testing procedure; please refer to the statistical analysis plan for details.||0.0|-1.0|1
71925544|NCT02163759|143371329|SUPERIORITY||Mean Difference (Net)|-0.3||||1|TWO_SIDED|95.0|-0.7|0.1||p-value has been adjusted for multiplicity.|Mixed Model for Repeated Measures|Model adjusted for treatment, visit, stratification factors, treatment-by-visit, baseline UC-PRO/SS domain, and baseline UC-PRO/SS domain-by-visit.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. This comparison was part of Family 6 of the testing procedure; please refer to the statistical analysis plan for details.||0.1|-0.7|1
71689270|NCT01763827|142894291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-38.93|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-42.0|-35.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-35.86|-42.00|<0.001
71689271|NCT01763827|142894291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-45.83|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-49.39|-42.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-42.27|-49.39|<0.001
71925545|NCT02163759|143371330|SUPERIORITY||Difference in Remission Rates|10.9||||0.0364|TWO_SIDED|95.0|-0.08|19.48||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||19.48|-0.08|0.0364
71925546|NCT02163759|143371330|SUPERIORITY||Difference in Remission Rates|-4.5||||0.3383|TWO_SIDED|95.0|-14.1|5.07||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||5.07|-14.10|0.3383
71925547|NCT02163759|143371331|SUPERIORITY||Difference in Remission Rates|6.2||||0.09|TWO_SIDED|95.0|-3.33|12.3||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||12.30|-3.33|0.0900
71925548|NCT02163759|143371331|SUPERIORITY||Difference in Remission Rates|-3.6||||0.3217|TWO_SIDED|95.0|-11.07|3.78||Nominal p-value; it has not been adjusted for multiplicity.|Cochran-Mantel-Haenszel|Difference and 95% CI adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL) and MCS (≤9 or ≥10) at BL.|Difference in remission rates was calculated as the etrolizumab arm minus the adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||3.78|-11.07|0.3217
71925549|NCT02163759|143371332|SUPERIORITY||Difference in Adjusted Means|1.3||||0.7919|TWO_SIDED|95.0|-8.3|10.8||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus placebo arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||10.8|-8.3|0.7919
71925550|NCT02163759|143371332|SUPERIORITY||Difference in Adjusted Means|-0.8||||0.8327|TWO_SIDED|95.0|-8.7|7.0||Nominal p-value; it has not been adjusted for multiplicity.|ANCOVA|Model adjusted for concomitant treatment with corticosteroids or immunosuppressants at baseline (BL), MCS (≤9 or ≥10) at BL, and IBDQ score at BL.|Mean difference was calculated as etrolizumab arm minus adalimumab arm.|Primary and secondary outcome measures were evaluated for statistical significance in a hierarchical manner with a component-wise multistage gatekeeping procedure. Please refer to the statistical analysis plan for details. This comparison was not considered a key secondary outcome measure and was not part of the multiple testing procedure for statistical significance.||7.0|-8.7|0.8327
71925551|NCT03471507|143371410|OTHER|||||||0.46|||||||Regression, Linear|Adjusted for age and sex.||||||0.46
71925552|NCT00750061|143371418|SUPERIORITY_OR_OTHER|||||||0.343|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (wk6-d0)||||0.343
71925553|NCT00750061|143371418|SUPERIORITY_OR_OTHER|||||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change light touch score (m6-d0)||||0.69
71925554|NCT00750061|143371418|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (wk6-d0)||||1
71925555|NCT00750061|143371418|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (m6-d0)||||0.32
71925556|NCT00750061|143371418|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (wk6-d0)||||1
71925557|NCT00750061|143371418|SUPERIORITY_OR_OTHER|||||||0.582|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||change motor score (m6-d0)||||0.582
71925558|NCT00750061|143371419|SUPERIORITY_OR_OTHER|||||||0.257|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (Wk6 - D0)||||0.257
71925559|NCT00750061|143371419|SUPERIORITY_OR_OTHER|||||||0.168|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||FIM change (M6 - D0)||||0.168
71925560|NCT00750061|143371419|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (Wk6 - D0)||||0.013
71925561|NCT00750061|143371419|SUPERIORITY_OR_OTHER|||||||0.137|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||VAS change (M6 - D0)||||0.137
71925562|NCT03246152|143371422|OTHER||||||>|0.05|||||||Pearson's correlation coefficient|||Correlation between change in BCVA and the pre treatment, post treatment, and change in vascular density following 3-6 injections was performed.||||>0.05
71925563|NCT01374516|143371447|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|60.8|||||TWO_SIDED|95.0|52.0|68.0||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow \& Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.||68.0|52.0|
71925564|NCT01374516|143371448|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.8||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.8|58.7|
71925565|NCT01374516|143371449|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|64.7|||||TWO_SIDED|95.0|58.7|69.9||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||69.9|58.7|
71925566|NCT01374516|143371450|SUPERIORITY_OR_OTHER_LEGACY||Vaccine Efficacy|61.9|||||TWO_SIDED|95.0|54.7|68.0||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.||68.0|54.7|
71925567|NCT00401726|143371508|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.25||||0.218|||||||Chi-squared|||||||0.218
71925568|NCT00401726|143371509|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.76||95.0|-0.92|1.25|||ANCOVA|||||1.25|-0.92|0.76
71689272|NCT01763827|142894291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-29.36|STANDARD_ERROR_OF_MEAN|1.56|<|0.001|TWO_SIDED|95.0|-32.43|-26.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-26.28|-32.43|<0.001
71925569|NCT00401726|143371510|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.148||95.0|-0.41|0.06|||ANCOVA|||||0.06|-0.41|0.148
71925570|NCT00401726|143371511|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.829||95.0|-1.09|0.87|||ANCOVA|||||0.87|-1.09|0.829
71925571|NCT00401726|143371512|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.57||||0.728|||||||Chi-squared|||||||0.728
71925572|NCT00401726|143371513|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.805||95.0|-2.24|1.74|||ANCOVA|||||1.74|-2.24|0.805
71925573|NCT00401726|143371514|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.123||95.0|-2.27|0.27|||ANCOVA|||||0.27|-2.27|0.123
71925574|NCT00401726|143371515|SUPERIORITY_OR_OTHER|||||||0.961|||||||Cochran-Mantel-Haenszel|p-value based on comparison of mean score differences||CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.||||0.961
71925575|NCT00830310|143371562|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||<0.001
71925576|NCT00830310|143371563|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
71925577|NCT00830310|143371564|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
71925578|NCT00830310|143371565|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.001
71925579|NCT00830310|143371566|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.001
71925580|NCT00830310|143371567|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.011
71925581|NCT00830310|143371568|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||0.038
71925582|NCT00830310|143371569|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.||||0.002
71925583|NCT00830310|143371570|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.||||<0.001
71925584|NCT01050998|143371571|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.578|TWO_SIDED|95.0|-11.5|22.0|||Fisher Exact||95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||22.0|-11.5|0.578
71925585|NCT01050998|143371571|SUPERIORITY_OR_OTHER||Percent difference|30.7|||<|0.001|TWO_SIDED|95.0|13.4|46.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||46.3|13.4|<0.001
71925586|NCT01050998|143371571|SUPERIORITY_OR_OTHER||Percent difference|15.3||||0.099|TWO_SIDED|95.0|-1.6|32.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||32.2|-1.6|0.099
71925587|NCT01050998|143371571|SUPERIORITY_OR_OTHER||Percent difference|35.5|||<|0.001|TWO_SIDED|95.0|17.8|50.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||50.6|17.8|<0.001
71925588|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.543|TWO_SIDED|95.0|-11.9|25.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||25.4|-11.9|0.543
71925589|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|26.3||||0.011|TWO_SIDED|95.0|7.2|43.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||43.6|7.2|0.011
71925590|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|16.6||||0.108|TWO_SIDED|95.0|-2.5|35.5|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.5|-2.5|0.108
71925591|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|32.0||||0.001|TWO_SIDED|95.0|12.5|49.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||49.0|12.5|0.001
71925592|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
71925593|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
71925594|NCT01050998|143371572|SUPERIORITY_OR_OTHER||Percent difference|9.8||||0.661|TWO_SIDED|95.0|-24.3|46.9|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||46.9|-24.3|0.661
71925595|NCT01050998|143371573|SUPERIORITY_OR_OTHER||Percent difference|13.0||||0.152|TWO_SIDED|95.0|-4.2|30.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||30.3|-4.2|0.152
71925596|NCT01050998|143371573|SUPERIORITY_OR_OTHER||Percent difference|24.3||||0.008|TWO_SIDED|95.0|7.0|40.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||40.3|7.0|0.008
71925597|NCT01050998|143371573|SUPERIORITY_OR_OTHER||Percent difference|21.4||||0.02|TWO_SIDED|95.0|3.9|37.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||37.8|3.9|0.020
71925598|NCT01050998|143371573|SUPERIORITY_OR_OTHER||Percent difference|29.0||||0.002|TWO_SIDED|95.0|11.3|45.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher's exact test.||45.0|11.3|0.002
71925599|NCT01050998|143371574|SUPERIORITY_OR_OTHER||Percent difference|9.9||||0.328|TWO_SIDED|95.0|-9.3|29.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||29.4|-9.3|0.328
71925600|NCT01050998|143371574|SUPERIORITY_OR_OTHER||Percent difference|17.2||||0.084|TWO_SIDED|95.0|-2.0|35.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||35.6|-2.0|0.084
71925601|NCT01050998|143371574|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.049|TWO_SIDED|95.0|0.7|38.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||38.2|0.7|0.049
71925602|NCT01050998|143371574|SUPERIORITY_OR_OTHER||Percent difference|22.8||||0.03|TWO_SIDED|95.0|3.2|40.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher's exact test.||40.7|3.2|0.030
71925603|NCT01050998|143371574|SUPERIORITY_OR_OTHER||Percent difference|26.8||||0.188|TWO_SIDED|95.0|-9.3|60.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||60.7|-9.3|0.188
71925604|NCT01050998|143371574|SUPERIORITY_OR_OTHER||Percent difference|57.4||||0.01|TWO_SIDED|95.0|15.2|81.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher's exact test.||81.8|15.2|0.010
71925605|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.205||0.137|TWO_SIDED|95.0|-0.71|0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.10|-0.71|0.137
71925606|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.202||0.001|TWO_SIDED|95.0|-1.07|-0.27|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.27|-1.07|0.001
71925607|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.35|STANDARD_ERROR_OF_MEAN|0.201||0.08|TWO_SIDED|95.0|-0.75|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.04|-0.75|0.080
71925608|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.204|<|0.001|TWO_SIDED|95.0|-1.14|-0.33|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.33|-1.14|<0.001
71925609|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.212||0.107|TWO_SIDED|95.0|-0.76|0.08|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.08|-0.76|0.107
71925610|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.21|<|0.001|TWO_SIDED|95.0|-1.17|-0.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.35|-1.17|<0.001
71925611|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.209||0.046|TWO_SIDED|95.0|-0.83|-0.01|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.01|-0.83|0.046
71925612|NCT01050998|143371595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.212|<|0.001|TWO_SIDED|95.0|-1.22|-0.38|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.38|-1.22|<0.001
71925613|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.086|TWO_SIDED|95.0|-0.85|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.06|-0.85|0.086
71925614|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.55|STANDARD_ERROR_OF_MEAN|0.225||0.016|TWO_SIDED|95.0|-0.99|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.10|-0.99|0.016
71925615|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.225||0.059|TWO_SIDED|95.0|-0.87|0.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.02|-0.87|0.059
71925616|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.227||0.002|TWO_SIDED|95.0|-1.14|-0.25|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.25|-1.14|0.002
71925617|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39|STANDARD_ERROR_OF_MEAN|0.241||0.107|TWO_SIDED|95.0|-0.87|0.09|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.09|-0.87|0.107
71925618|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.236||0.007|TWO_SIDED|95.0|-1.11|-0.18|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.18|-1.11|0.007
71925619|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.236||0.084|TWO_SIDED|95.0|-0.88|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.06|-0.88|0.084
71925620|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.238||0.002|TWO_SIDED|95.0|-1.2|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.26|-1.20|0.002
71925621|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.12|STANDARD_ERROR_OF_MEAN|0.447||0.785|TWO_SIDED|95.0|-0.78|1.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||1.02|-0.78|0.785
71925622|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.19|STANDARD_ERROR_OF_MEAN|0.465||0.014|TWO_SIDED|95.0|-2.13|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||-0.26|-2.13|0.014
71925623|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.04|STANDARD_ERROR_OF_MEAN|0.448||0.931|TWO_SIDED|95.0|-0.94|0.86|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.86|-0.94|0.931
71925624|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.465||0.07|TWO_SIDED|95.0|-1.8|0.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.||0.07|-1.80|0.070
71925625|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.449||0.854|TWO_SIDED|95.0|-0.99|0.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.82|-0.99|0.854
71925626|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.468||0.011|TWO_SIDED|95.0|-2.19|-0.31|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.31|-2.19|0.011
71689273|NCT01763827|142894291|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-27.51|STANDARD_ERROR_OF_MEAN|1.81|<|0.001|TWO_SIDED|95.0|-31.08|-23.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-23.94|-31.08|<0.001
71689274|NCT01763827|142894292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-39.63|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|-42.97|-36.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-36.30|-42.97|<0.001
71925627|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.448||0.271|TWO_SIDED|95.0|-1.4|0.4|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||0.40|-1.40|0.271
71925628|NCT01050998|143371596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.465||0.031|TWO_SIDED|95.0|-1.97|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.||-0.10|-1.97|0.031
71925629|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|7.0||||0.238|TWO_SIDED|95.0|-3.3|20.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||20.5|-3.3|0.238
71925630|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|14.8||||0.017|TWO_SIDED|95.0|2.8|29.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||29.7|2.8|0.017
71925631|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.09|TWO_SIDED|95.0|0.0|25.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||25.4|0.0|0.090
71925632|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|15.8||||0.015|TWO_SIDED|95.0|2.9|31.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher's exact test.||31.0|2.9|0.015
71925633|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|3.0||||0.412|TWO_SIDED|95.0|-4.2|14.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.0|-4.2|0.412
71925634|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.237|TWO_SIDED|95.0|-2.9|16.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.4|-2.9|0.237
71925635|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|5.1||||0.231|TWO_SIDED|95.0|-2.8|16.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||16.8|-2.8|0.231
71925636|NCT01050998|143371597|SUPERIORITY_OR_OTHER||Percent difference|3.1||||0.406|TWO_SIDED|95.0|-4.1|14.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher's exact test.||14.4|-4.1|0.406
71925637|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|8.7||||0.182|TWO_SIDED|95.0|-2.7|24.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||24.4|-2.7|0.182
71925638|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|10.4||||0.11|TWO_SIDED|95.0|-1.2|25.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||25.5|-1.2|0.110
71925639|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|11.3||||0.104|TWO_SIDED|95.0|-0.6|26.9|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||26.9|-0.6|0.104
71925640|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|16.4||||0.016|TWO_SIDED|95.0|3.5|32.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||32.7|3.5|0.016
71925641|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.115|TWO_SIDED|95.0|-1.0|19.3|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||19.3|-1.0|0.115
71925642|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|8.4||||0.052|TWO_SIDED|95.0|0.6|21.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||21.6|0.6|0.052
71925643|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
71925644|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
71689275|NCT01763827|142894292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-44.67|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-48.66|-40.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-40.68|-48.66|<0.001
71689276|NCT01763827|142894292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-28.42|STANDARD_ERROR_OF_MEAN|1.68|<|0.001|TWO_SIDED|95.0|-31.73|-25.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-25.10|-31.73|<0.001
71689277|NCT01763827|142894292|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-25.31|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-29.31|-21.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-21.31|-29.31|<0.001
71925645|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|10.5||||0.591|TWO_SIDED|95.0|-18.2|46.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||46.2|-18.2|0.591
71925646|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|13.2||||0.57|TWO_SIDED|95.0|-16.6|51.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[CRP\]): p-value was calculated using a two-tailed Fisher's exact test.||51.4|-16.6|0.570
71925647|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
71925648|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
71925649|NCT01050998|143371598|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 \[ESR\]): p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
71925650|NCT01050998|143371599|SUPERIORITY_OR_OTHER||Percent difference|||||0.604|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.604
71925651|NCT01050998|143371599|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||<0.001
71925652|NCT01050998|143371599|SUPERIORITY_OR_OTHER|||||||0.145|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.||||0.145
71925653|NCT01050998|143371599|SUPERIORITY_OR_OTHER|||||||0.282|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.282
71925654|NCT01050998|143371599|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||<0.001
71925655|NCT01050998|143371599|SUPERIORITY_OR_OTHER|||||||0.047|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.||||0.047
71925656|NCT01050998|143371600|SUPERIORITY_OR_OTHER||Percent difference|||||0.237|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.237
71925657|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.005
71925658|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.134|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||0.134
71925659|NCT01050998|143371600|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.||||<0.001
71925660|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.265|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.265
71925661|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.013|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.013
71925662|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.952|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.952
71925663|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.004|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.||||0.004
71925664|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.246|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.246
71925665|NCT01050998|143371600|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||<0.001
71925666|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.126|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.||||0.126
71925667|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.831|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.831
71925668|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.005|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.005
71925669|NCT01050998|143371600|SUPERIORITY_OR_OTHER|||||||0.125|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||0.125
71925670|NCT01050998|143371600|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.||||<0.001
71925671|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.15||||0.486|TWO_SIDED|95.0|0.78|1.69|||Exponential,Weibull and Log normal model||Ratio greater than (\>) 1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||1.69|0.78|0.486
71925672|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.54||||0.015|TWO_SIDED|95.0|1.09|2.18|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.18|1.09|0.015
71925673|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.65||||0.006|TWO_SIDED|95.0|1.15|2.36|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.36|1.15|0.006
71925674|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|2.09|||<|0.001|TWO_SIDED|95.0|1.49|2.93|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.||2.93|1.49|<0.001
71925675|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|0.97||||0.906|TWO_SIDED|95.0|0.61|1.55|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.55|0.61|0.906
71925676|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.89|||<|0.001|TWO_SIDED|95.0|1.31|2.71|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.71|1.31|<0.001
71925677|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.26||||0.272|TWO_SIDED|95.0|0.83|1.91|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||1.91|0.83|0.272
71925678|NCT01050998|143371601|SUPERIORITY_OR_OTHER||Ratio of expected duration of response|1.91|||<|0.001|TWO_SIDED|95.0|1.34|2.72|||Exponential,Weibull and Log normal model||Ratio \>1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.||2.72|1.34|<0.001
71925679|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.589|TWO_SIDED|95.0|-12.1|22.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||22.0|-12.1|0.589
71925680|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|20.2||||0.032||95.0|2.8|36.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||36.7|2.8|0.032
71925681|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|0.5||||1|TWO_SIDED|95.0|-16.0|18.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||18.0|-16.0|1.000
71925682|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|33.3|||<|0.001|TWO_SIDED|95.0|15.6|48.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher's exact test.||48.6|15.6|<0.001
71925683|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|8.9||||0.212|TWO_SIDED|95.0|-3.5|23.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||23.6|-3.5|0.212
71925684|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|18.7||||0.011|TWO_SIDED|95.0|4.8|34.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||34.0|4.8|0.011
71925685|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|4.7||||0.446|TWO_SIDED|95.0|-7.0|19.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||19.1|-7.0|0.446
71925686|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|22.1||||0.003|TWO_SIDED|95.0|7.6|37.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher's exact test.||37.8|7.6|0.003
71925687|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-8.9|9.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||9.7|-8.9|1.000
71925688|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|4.8||||0.317|TWO_SIDED|95.0|-4.1|17.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||17.5|-4.1|0.317
71925689|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|0.8||||1|TWO_SIDED|95.0|-7.2|12.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||12.1|-7.2|1.000
71925690|NCT01050998|143371602|SUPERIORITY_OR_OTHER||Percent difference|9.5||||0.106|TWO_SIDED|95.0|-0.5|23.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher's exact test.||23.5|-0.5|0.106
71925691|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
71925692|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|16.1||||0.12|TWO_SIDED|95.0|-3.1|34.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||34.4|-3.1|0.120
71925693|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|1.0||||1|TWO_SIDED|95.0|-17.7|20.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||20.4|-17.7|1.000
71925694|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|29.2||||0.005|TWO_SIDED|95.0|9.7|46.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||46.1|9.7|0.005
71925695|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|20.9||||0.382|TWO_SIDED|95.0|-16.4|55.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||55.9|-16.4|0.382
71925696|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|39.0||||0.087|TWO_SIDED|95.0|-2.7|69.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||69.6|-2.7|0.087
71925697|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|-1.3||||1|TWO_SIDED|95.0|-33.7|35.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||35.7|-33.7|1.000
71925698|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|51.5||||0.028|TWO_SIDED|95.0|8.2|77.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher's exact test.||77.0|8.2|0.028
71925699|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|11.1||||0.175|TWO_SIDED|95.0|-2.9|27.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||27.9|-2.9|0.175
71925700|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|17.3||||0.026|TWO_SIDED|95.0|2.4|34.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.1|2.4|0.026
71925701|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|8.5||||0.271|TWO_SIDED|95.0|-5.1|24.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||24.9|-5.1|0.271
71925702|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|18.8||||0.021|TWO_SIDED|95.0|3.4|36.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||36.0|3.4|0.021
71925703|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|-0.7||||1|TWO_SIDED|95.0|-27.0|34.8|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||34.8|-27.0|1.000
71925704|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|25.7||||0.283|TWO_SIDED|95.0|-8.8|63.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||63.2|-8.8|0.283
71925705|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
71925706|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|38.2||||0.059|TWO_SIDED|95.0|1.6|71.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher's exact test.||71.2|1.6|0.059
71925707|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-7.0|14.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||14.2|-7.0|1.000
71925708|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|5.8||||0.242|TWO_SIDED|95.0|-3.7|19.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||19.4|-3.7|0.242
71925709|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.41|TWO_SIDED|95.0|-5.1|16.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||16.9|-5.1|0.410
71925710|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|13.9||||0.03|TWO_SIDED|95.0|2.7|29.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||29.5|2.7|0.030
71925711|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||0.529|TWO_SIDED|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.7|-35.0|0.529
71925712|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|0.7||||1|TWO_SIDED|95.0|-26.7|39.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||39.5|-26.7|1.000
71925713|NCT01050998|143371603|SUPERIORITY_OR_OTHER||Percent difference|-11.8||||1|TWO_SIDED|95.0|-37.5|22.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher's exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher's exact test.||22.6|-37.5|1.000
71925714|NCT01050998|143371605|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.05|STANDARD_ERROR_OF_MEAN|7.162||0.051|TWO_SIDED|95.0|-0.05|28.15|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.15|-0.05|0.051
71925715|NCT01050998|143371605|SUPERIORITY_OR_OTHER||Adjusted Mean difference|21.23|STANDARD_ERROR_OF_MEAN|7.028||0.003|TWO_SIDED|95.0|7.39|35.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||35.07|7.39|0.003
71925716|NCT01050998|143371605|SUPERIORITY_OR_OTHER||Adjusted Mean difference|7.09|STANDARD_ERROR_OF_MEAN|7.136||0.322|TWO_SIDED|95.0|-6.96|21.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||21.14|-6.96|0.322
71925717|NCT01050998|143371605|SUPERIORITY_OR_OTHER||Adjusted Mean difference|32.03|STANDARD_ERROR_OF_MEAN|7.085|<|0.001|TWO_SIDED|95.0|18.08|45.98|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||45.98|18.08|<0.001
71925718|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted Mean difference|14.49|STANDARD_ERROR_OF_MEAN|7.981||0.071|TWO_SIDED|95.0|-1.24|30.22|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||30.22|-1.24|0.071
71925719|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|19.43|STANDARD_ERROR_OF_MEAN|7.798||0.013|TWO_SIDED|95.0|4.06|34.8|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||34.80|4.06|0.013
71925720|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|7.84|STANDARD_ERROR_OF_MEAN|7.873||0.32|TWO_SIDED|95.0|-7.68|23.36|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||23.36|-7.68|0.320
71925721|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.37|STANDARD_ERROR_OF_MEAN|7.873|<|0.001|TWO_SIDED|95.0|15.85|46.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for European region.||46.89|15.85|<0.001
71925722|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|12.11|STANDARD_ERROR_OF_MEAN|17.089||0.483|TWO_SIDED|95.0|-22.41|46.64|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||46.64|-22.41|0.483
71925723|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|31.24|STANDARD_ERROR_OF_MEAN|17.089||0.075|TWO_SIDED|95.0|-3.28|65.77|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||65.77|-3.28|0.075
71925724|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22|STANDARD_ERROR_OF_MEAN|17.872||0.815|TWO_SIDED|95.0|-31.89|40.32|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||40.32|-31.89|0.815
71925725|NCT01050998|143371606|SUPERIORITY_OR_OTHER||Adjusted mean difference|36.11|STANDARD_ERROR_OF_MEAN|17.089||0.041|TWO_SIDED|95.0|1.58|70.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|Analysis reported for Japanese region.||70.63|1.58|0.041
71925726|NCT00370994|143371676|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Comparisons were made between groups and within the group between baseline and different time points.|Repeated measures ANOVA.|||||||<0.001
71925727|NCT00370994|143371677|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||There were significant differences in Oswestry Disability Index between both groups|Repeated measures of ANOVA|||||||0.001
71925728|NCT04246593|143371680|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites. In order to further explore the intervention effect, we fit GLMMs that adjust for (1) baseline dietary intake and (2) race and baseline income.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.52||0.84|TWO_SIDED|||||P-value calculated for the mean difference between the user and non-user groups.|GLMM|||||||0.84
71925729|NCT04246593|143371681|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Median Difference (Net)|-0.59|STANDARD_ERROR_OF_MEAN|1.15||0.61|TWO_SIDED|||||P-value calculated for the mean difference between change in BMI for intervention and control groups.|GLMM|||||||0.61
71925730|NCT04246593|143371682|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-28.02|STANDARD_ERROR_OF_MEAN|43.31||0.53|TWO_SIDED|||||P-value calculated for the mean difference in change scores between the intervention and control groups.|GLMM|||||||0.53
71925731|NCT04246593|143371683|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.53|STANDARD_ERROR_OF_MEAN|1.65||0.75|TWO_SIDED|||||The p-value applies to the mean difference in mean self-efficacy change scores between the intervention and control groups.|GLMM|||||||0.75
71925732|NCT04246593|143371684|OTHER|We used generalized linear mixed model (GLMM) with random intercept to control for clustering within sites.|Mean Difference (Net)|-0.56|STANDARD_ERROR_OF_MEAN|1.13||0.63|TWO_SIDED|||||P-value applies to the mean difference in mean total barriers score change between the intervention and control groups.|GLMM|||||||0.63
71925733|NCT02369874|143371691|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.7624|TWO_SIDED|95.0|0.85|1.26|||Log Rank|||||1.26|0.85|0.7624
71925734|NCT02369874|143371691|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.1993|TWO_SIDED|95.0|0.72|1.08|||Log Rank|||||1.08|0.72|0.1993
71925735|NCT02369874|143371692|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.459|TWO_SIDED|95.0|0.73|1.17|||Log Rank|||||1.17|0.73|0.4590
71925736|NCT02369874|143371692|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.85|1.36||||||||1.36|0.85|
71925737|NCT02369874|143371693|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.63|1.39||||||||1.39|0.63|
71925738|NCT02369874|143371694|SUPERIORITY||Hazard Ratio (HR)|1.09|||||TWO_SIDED|95.0|0.9|1.33||||||||1.33|0.90|
71925739|NCT02369874|143371694|SUPERIORITY||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.84|1.25||||||||1.25|0.84|
71925740|NCT02369874|143371695|SUPERIORITY||Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.67|1.7||||||||1.70|0.67|
71925741|NCT02369874|143371695|SUPERIORITY||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.66|1.68||||||||1.68|0.66|
71925742|NCT02369874|143371697|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.67|1.52||||||6 Month analysis||1.52|0.67|
71925743|NCT02369874|143371697|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.64|1.46||||||6 Month analysis||1.46|0.64|
71925744|NCT02369874|143371697|SUPERIORITY||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.72|1.75||||||12 Month analysis||1.75|0.72|
71925745|NCT02369874|143371697|SUPERIORITY||Odds Ratio (OR)|1.0|||||TWO_SIDED|95.0|0.63|1.57||||||12 Month analysis||1.57|0.63|
71925746|NCT02369874|143371700|SUPERIORITY||Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.76|1.21||||||||1.21|0.76|
71925747|NCT02369874|143371701|SUPERIORITY||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.74|2.39||||||||2.39|0.74|
71925748|NCT00620191|143371747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|1.92||0.05|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
71925749|NCT00620191|143371747|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|4.1|STANDARD_DEVIATION|1.36||0.05|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog value|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.05
71925750|NCT00620191|143371748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.98|STANDARD_DEVIATION|1.01||0.06|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.06
71925751|NCT00620191|143371748|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_DEVIATION|0.91||0.34|TWO_SIDED||||||ANCOVA|adjusted for baseline ADAS-Cog score.|The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
71925752|NCT00620191|143371749|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|2.14||0.36|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.36
71925753|NCT00620191|143371750|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|5.09|STANDARD_DEVIATION|4.73||0.34|TWO_SIDED||||||t-test, 2 sided||The difference is the value for the metformin arm minus the value for the placebo arm.|||||0.34
71925754|NCT00145795|143371770|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 3 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.81
71925755|NCT00145795|143371771|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||||||Significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 6 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.||||0.03
71925756|NCT00145795|143371772|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 3 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.08
71689278|NCT01763827|142894293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.12|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-53.12|-45.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.12|-53.12|<0.001
71689279|NCT01763827|142894293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-54.95|STANDARD_ERROR_OF_MEAN|2.12|<|0.001|TWO_SIDED|95.0|-59.12|-50.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-50.78|-59.12|<0.001
71689280|NCT01763827|142894293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-34.73|STANDARD_ERROR_OF_MEAN|2.03|<|0.001|TWO_SIDED|95.0|-38.73|-30.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-30.73|-38.73|<0.001
71925757|NCT00145795|143371773|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 3 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.29
71925758|NCT00145795|143371774|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 6 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.||||0.29
71925759|NCT00145795|143371775|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 6 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.||||0.04
71925760|NCT00145795|143371776|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 3 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.21
71925761|NCT00145795|143371777|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 6 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.||||0.61
71925762|NCT00570492|143371783|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|||||TWO_SIDED|95.0|-0.48|-0.06|||||An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.|||-0.06|-0.48|
71925763|NCT05510297|143371827|SUPERIORITY||Median Difference (Net)|7.0||||0.007|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.007
71925764|NCT05510297|143371828|SUPERIORITY||Mean Difference (Final Values)|2653.16|STANDARD_DEVIATION|5110.86||0.074|TWO_SIDED|95.0|-297.76522|5604.07522||a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made; data were checked for normality using the Shapiro-Wilk test where p\>0.05 was interpreted as likely normal distribution.|t-test, 2 sided|||||5604.07522|-297.76522|0.074
71925765|NCT05510297|143371829|SUPERIORITY|a priori threshold for statistical significance=0.05 for 2-sided t-test; no adjustments for multiple comparisons made;|Mean Difference (Net)|4.44067|STANDARD_DEVIATION|41.59009||0.685|TWO_SIDED|95.0|-18.59116|27.47249|||t-test, 2 sided|||||27.47249|-18.59116|0.685
71925766|NCT05510297|143371830|SUPERIORITY||Mean Difference (Net)|-0.51267|STANDARD_DEVIATION|1.44656||0.191|TWO_SIDED|95.0|-1.31374|0.28841|||t-test, 2 sided|||||0.28841|-1.31374|0.191
71925767|NCT05510297|143371831|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_DEVIATION|1.35026||0.218|TWO_SIDED|95.0|-1.19775|0.29775|||t-test, 2 sided|||||0.29775|-1.19775|0.218
71925768|NCT05510297|143371832|SUPERIORITY||Mean Difference (Net)|-0.924|STANDARD_DEVIATION|2.19396||0.125|TWO_SIDED|95.0|-2.13898|0.29098|||t-test, 2 sided|||||0.29098|-2.13898|0.125
71689281|NCT01763827|142894293|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-36.62|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-40.81|-32.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-32.42|-40.81|<0.001
71689282|NCT01763827|142894294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-49.57|STANDARD_ERROR_OF_MEAN|2.14|<|0.001|TWO_SIDED|95.0|-53.78|-45.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-45.36|-53.78|<0.001
71925769|NCT05510297|143371833|SUPERIORITY||Mean Difference (Net)|0.00133|STANDARD_DEVIATION|0.10148||0.96|TWO_SIDED|95.0|-0.05486|0.5753|||t-test, 2 sided|||||0.5753|-0.05486|0.960
71925770|NCT05510297|143371837|SUPERIORITY||Mean Difference (Net)|-0.622|STANDARD_DEVIATION|1.6553||0.168|TWO_SIDED|95.0|-1.53867|0.29467|||t-test, 2 sided|||||0.29467|-1.53867|0.168
71925771|NCT04409262|143371838|SUPERIORITY||Hazard Ratio (HR)|0.965||||0.7414|TWO_SIDED|95.0|0.78|1.19|||Log Rank|||||1.19|0.78|0.7414
71925772|NCT04409262|143371839|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.8993|TWO_SIDED|95.0|0.72|1.34|||Log Rank|||||1.34|0.72|0.8993
71925773|NCT04409262|143371840|SUPERIORITY||Odds Ratio (OR)|1.05||||0.7648|TWO_SIDED|95.0|0.77|1.44|||Regression, Logistic|||||1.44|0.77|0.7648
71925774|NCT04409262|143371841|SUPERIORITY||Hazard Ratio (HR)|0.948||||0.7867|TWO_SIDED|95.0|0.65|1.39|||Log Rank|||||1.39|0.65|0.7867
71925775|NCT04409262|143371842|SUPERIORITY||Hazard Ratio (HR)|0.882||||0.4602|TWO_SIDED|95.0|0.63|1.23|||Log Rank|||||1.23|0.63|0.4602
71925776|NCT04409262|143371843|SUPERIORITY||Hazard Ratio (HR)|0.982||||0.8664|TWO_SIDED|95.0|0.8|1.21|||Log Rank|||||1.21|0.80|0.8664
71925777|NCT04409262|143371844|SUPERIORITY||Odds Ratio (OR)|1.01||||0.9569|TWO_SIDED|95.0|0.75|1.35|||Regression, Logistic|||||1.35|0.75|0.9569
71925778|NCT04409262|143371845|SUPERIORITY||Odds Ratio (OR)|1.09||||0.6331|TWO_SIDED|95.0|0.78|1.52|||Regression, Logistic|||||1.52|0.78|0.6331
71925779|NCT04409262|143371846|SUPERIORITY||Odds Ratio (OR)|0.99||||0.9622|TWO_SIDED|95.0|0.7|1.4|||Regression, Logistic|||||1.40|0.70|0.9622
71925780|NCT04409262|143371847|SUPERIORITY||Odds Ratio (OR)|1.14||||0.485|TWO_SIDED|95.0|0.79|1.64|||Regression, Logistic|||||1.64|0.79|0.4850
71925781|NCT04409262|143371848|SUPERIORITY||Weighted % difference|-2.2||||0.5915|TWO_SIDED|95.0|-10.2|5.9|||Cochran-Mantel-Haenszel|||Day 28||5.9|-10.2|0.5915
71925782|NCT04409262|143371848|SUPERIORITY||Weighted % difference|-2.5||||0.5494|TWO_SIDED|95.0|-10.5|5.6|||Cochran-Mantel-Haenszel|||Day 60||5.6|-10.5|0.5494
71925783|NCT04409262|143371849|SUPERIORITY||Weighted % difference|-14.1||||0.259|TWO_SIDED|95.0|-37.4|9.2|||Cochran-Mantel-Haenszel|||Day 28||9.2|-37.4|0.2590
71925784|NCT04409262|143371849|SUPERIORITY||Weighted % difference|-14.6||||0.229|TWO_SIDED|95.0|-37.0|7.8|||Cochran-Mantel-Haenszel|||Day 60||7.8|-37.0|0.2290
71925785|NCT04409262|143371850|SUPERIORITY||Mean Difference (Final Values)|3.1125||||0.2434|TWO_SIDED|95.0|-2.16|8.38|||Regression, Linear|||||8.38|-2.16|0.2434
71925786|NCT04409262|143371851|SUPERIORITY||Weighted % difference|0.6||||0.8222|TWO_SIDED|95.0|-4.4|5.6|||Cochran-Mantel-Haenszel|||Day 14||5.6|-4.4|0.8222
71925787|NCT04409262|143371851|SUPERIORITY||Weighted % difference|-1.3||||0.6944|TWO_SIDED|95.0|-7.8|5.2|||Cochran-Mantel-Haenszel|||Day 28||5.2|-7.8|0.6944
71925788|NCT04409262|143371851|SUPERIORITY||Weighted % difference|-3.0||||0.3919|TWO_SIDED|95.0|-10.1|4.0|||Cochran-Mantel-Haenszel|||Day 60||4.0|-10.1|0.3919
71925789|NCT04409262|143371852|SUPERIORITY||Hazard Ratio (HR)|0.957||||0.6778|TWO_SIDED|95.0|0.78|1.18|||Log Rank|||||1.18|0.78|0.6778
71925790|NCT04409262|143371853|SUPERIORITY||Weighted % difference|-0.9||||0.7692|TWO_SIDED|95.0|-8.7|6.8|||Cochran-Mantel-Haenszel|||||6.8|-8.7|0.7692
71925791|NCT04409262|143371854|SUPERIORITY||Weighted % difference|-0.3||||0.9334|TWO_SIDED|95.0|-7.8|7.2|||Cochran-Mantel-Haenszel|||||7.2|-7.8|0.9334
71925792|NCT01738672|143371871|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71925793|NCT01738672|143371872|OTHER|||||||0.73|||||||t-test, 2 sided|||||||0.73
71925794|NCT01738672|143371873|OTHER|||||||0.56|||||||t-test, 2 sided|||||||0.56
71925795|NCT03289676|143371883|SUPERIORITY|||||||0.29|||||||Fisher Exact|||||||0.29
71925796|NCT03289676|143371885|OTHER||Odds Ratio, log|1.12||||0.029|TWO_SIDED|95.0|1.0|1.24|||Regression, Logistic|||||1.24|1.00|0.029
71925797|NCT01678794|143371886|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.26
71925798|NCT01678794|143371887|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71925799|NCT02260804|143371903|EQUIVALENCE|The equivalence margin of ±17% was predefined.|Difference in proportion|1.8|||||TWO_SIDED|90.0|-6.43|10.2||||||||10.2|-6.43|
71925800|NCT02207413|143371929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV\_LP/ D-QIV\_IP) is ≤ 1.5.|Adjusted GMT Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/ Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.11|0.85|
71925801|NCT02207413|143371929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.05|||||TWO_SIDED|95.0|0.94|1.18|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.18|0.94|
71925802|NCT02207413|143371929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.03|||||TWO_SIDED|95.0|0.91|1.16|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.16|0.91|
71925803|NCT02207413|143371929|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/ Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.04|||||TWO_SIDED|95.0|0.9|1.21|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.21|0.90|
71689283|NCT01763827|142894294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-52.77|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-57.28|-48.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|||-48.26|-57.28|<0.001
71689284|NCT01763827|142894294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-35.76|STANDARD_ERROR_OF_MEAN|2.13|<|0.001|TWO_SIDED|95.0|-39.95|-31.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-31.57|-39.95|<0.001
71689285|NCT01763827|142894294|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Treatment Difference|-33.97|STANDARD_ERROR_OF_MEAN|2.29|<|0.001|TWO_SIDED|95.0|-38.48|-29.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|||-29.45|-38.48|<0.001
71925804|NCT02207413|143371930|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT ratio|1.07|||||TWO_SIDED|95.0|0.9|1.28|||ANCOVA|||The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.28|0.90|
71925805|NCT02207413|143371930|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5|Adjusted GMT Ratio|1.18|||||TWO_SIDED|95.0|1.0|1.39|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.39|1.00|
71925806|NCT02207413|143371930|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.07|||||TWO_SIDED|95.0|0.91|1.27|||ANCOVA|||The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.||1.27|0.91|
71925807|NCT02207413|143371930|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra\_LP/Influsplit Tetra\_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.17|||||TWO_SIDED|95.0|0.99|1.38|||ANCOVA||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate||1.38|0.99|
71925808|NCT02777554|143371968|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% confidence intervals (CIs) of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|101.6|||||TWO_SIDED|90.0|95.1|108.5|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an analysis of variance (ANOVA) model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 Cmax.||108.5|95.1|
71925809|NCT02777554|143371969|EQUIVALENCE|Equivalent exposure of the QD formulation to the BID tablet was established if the 90% CIs of the geometric mean ratio for Day 7 AUC0-24 and Cmax were completely contained within the range of 80% to 125%.|Ratio (%) of Geometric Means|95.3|||||TWO_SIDED|90.0|88.9|102.2|||||Geometric mean ratio (Apremilast 75 mg XL QD / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To assess the exposure between the extended release apremilast formulation, and Reference IR (30 mg reference IR BID) tablet following multiple oral doses, an ANOVA model, with sequence, period, and treatment as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Day 7 AUC0-24.||102.2|88.9|
71689286|NCT01763827|142894295|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.48|||<|0.001|TWO_SIDED|95.0|-25.28|-11.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.68|-25.28|<0.001
71689287|NCT01763827|142894295|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-19.24|||<|0.001|TWO_SIDED|95.0|-23.2|-15.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-15.28|-23.20|<0.001
71689288|NCT01763827|142894295|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-18.37|||<|0.001|TWO_SIDED|95.0|-24.39|-12.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.35|-24.39|<0.001
71689289|NCT01763827|142894295|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.15|||<|0.001|TWO_SIDED|95.0|-23.23|-11.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.08|-23.23|<0.001
71689290|NCT01763827|142894296|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-27.76|-13.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-13.06|-27.76|<0.001
71689291|NCT01763827|142894296|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.82|||<|0.001|TWO_SIDED|95.0|-24.51|-11.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-11.12|-24.51|<0.001
71689292|NCT01763827|142894296|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.41|||<|0.001|TWO_SIDED|95.0|-28.13|-12.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-12.69|-28.13|<0.001
71689293|NCT01763827|142894296|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-15.77|||<|0.001|TWO_SIDED|95.0|-24.39|-7.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.14|-24.39|<0.001
71689294|NCT01763827|142894297|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.27||||0.72|TWO_SIDED|95.0|-13.27|2.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.73|-13.27|0.72
71689295|NCT01763827|142894297|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.59|||<|0.001|TWO_SIDED|95.0|-30.98|-10.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.20|-30.98|<0.001
71689296|NCT01763827|142894297|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.71||||0.027|TWO_SIDED|95.0|-16.86|1.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.45|-16.86|0.027
71689297|NCT01763827|142894297|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-11.73||||0.044|TWO_SIDED|95.0|-21.19|-2.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-2.27|-21.19|0.044
71689298|NCT01763827|142894298|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-6.23||||0.72|TWO_SIDED|95.0|-16.41|3.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||3.95|-16.41|0.72
71689299|NCT01763827|142894298|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-17.65|||<|0.001|TWO_SIDED|95.0|-26.67|-8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm|||-8.63|-26.67|<0.001
71689300|NCT01763827|142894298|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.14||||0.027|TWO_SIDED|95.0|-17.54|1.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||1.26|-17.54|0.027
71689301|NCT01763827|142894298|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-13.23||||0.044|TWO_SIDED|95.0|-21.69|-4.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.77|-21.69|0.044
71689302|NCT01763827|142894299|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-4.59||||0.072|TWO_SIDED|95.0|-11.3|2.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.12|-11.30|0.072
71689303|NCT01763827|142894299|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-20.39|||<|0.001|TWO_SIDED|95.0|-30.11|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-10.68|-30.11|<0.001
71689304|NCT01763827|142894299|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-5.71||||0.082|TWO_SIDED|95.0|-14.13|2.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.71|-14.13|0.082
71689305|NCT01763827|142894299|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.84||||0.044|TWO_SIDED|95.0|-22.14|-3.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baselie value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-3.54|-22.14|0.044
71925810|NCT02777554|143371970|OTHER||Ratio (%) of Geometric Means|103.9|||||TWO_SIDED|90.0|93.6|115.4|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||115.4|93.6|
71925811|NCT02777554|143371970|OTHER||Ratio (%) of Geometric Means|90.9|||||TWO_SIDED|90.0|81.6|101.3|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||101.3|81.6|
71925812|NCT02777554|143371970|OTHER||Ratio (%) of Geometric Means|115.0|||||TWO_SIDED|90.0|103.3|128.1|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||128.1|103.3|
71925813|NCT02777554|143371970|OTHER||Ratio (%) of Geometric Means|126.5|||||TWO_SIDED|90.0|113.7|140.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed Cmax of apremilast.||140.8|113.7|
71925814|NCT02777554|143371971|OTHER||Ratio (%) of Geometric Means|92.9|||||TWO_SIDED|90.0|81.3|106.2|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||106.2|81.3|
71925815|NCT02777554|143371971|OTHER||Ratio (%) of Geometric Means|86.0|||||TWO_SIDED|90.0|74.9|98.7|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||98.7|74.9|
71925816|NCT02777554|143371971|OTHER||Ratio (%) of Geometric Means|97.3|||||TWO_SIDED|90.0|84.9|111.6|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||111.6|84.9|
71925817|NCT02777554|143371971|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-t of apremilast.||129.7|98.8|
71925818|NCT02777554|143371972|OTHER||Ratio (%) of Geometric Means|92.6|||||TWO_SIDED|90.0|81.1|105.9|||||Geometric mean ratio (Apremilast 75 mg XL / Apremilast 30 mg IR BID) from an ANOVA model, expressed as a percentage.|To estimate the exposure of apremilast following single dose administration of extended release (QD) relative to the Reference IR (BID) tablet under fasted conditions, an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||105.9|81.1|
71925819|NCT02777554|143371972|OTHER||Ratio (%) of Geometric Means|86.1|||||TWO_SIDED|90.0|75.0|98.8|||||Geometric mean ratio (Apremilast 75 mg XL (Fasted) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||98.8|75.0|
71925820|NCT02777554|143371972|OTHER||Ratio (%) of Geometric Means|97.5|||||TWO_SIDED|90.0|85.0|111.8|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Standard Meal)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||111.8|85.0|
71925821|NCT02777554|143371972|OTHER||Ratio (%) of Geometric Means|113.2|||||TWO_SIDED|90.0|98.8|129.7|||||Geometric mean ratio (Apremilast 75 mg XL (High Fat) / Apremilast 75 mg XL (Fasted)) from an ANOVA model, expressed as a percentage.|To estimate the effect of food on the PK of a single oral dose of extended release apremilast (QD), an ANOVA model with treatment, sequence, and period as fixed effects, and subject nested within sequence as a random effect, was performed on the natural log-transformed AUC0-∞ of apremilast.||129.7|98.8|
71925822|NCT00066573|143372002|SUPERIORITY|To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.|Hazard Ratio (HR)|1.02||||0.85|TWO_SIDED|95.0|0.87|1.18|||Log Rank|||||1.18|0.87|0.85
71925823|NCT00066573|143372003|SUPERIORITY|No power calculation for secondary analysis|Hazard Ratio (HR)|0.93||||0.46|TWO_SIDED|95.0|0.77|1.13|||Log Rank|||||1.13|0.77|0.46
71925824|NCT01241591|143372008|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% lower confidence intervals (LCIs) of the difference for PGA and Psoriasis Area and Severity Index 75 (PASI75) responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA response and PASI75 at Week 12.|Mean Difference|-19.16|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-26.55|-11.76||||||Difference from Etanercept (Active-Etanercept)||-11.76|-26.55|
71689306|NCT01763827|142894300|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-7.94||||0.72|TWO_SIDED|95.0|-18.81|2.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||2.92|-18.81|0.72
71689307|NCT01763827|142894300|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-16.33|||<|0.001|TWO_SIDED|95.0|-25.64|-7.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-7.02|-25.64|<0.001
71689308|NCT01763827|142894300|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-8.58||||0.082|TWO_SIDED|95.0|-18.1|0.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||0.94|-18.10|0.082
71689309|NCT01763827|142894300|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|-12.72||||0.044|TWO_SIDED|95.0|-20.89|-4.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||-4.54|-20.89|0.044
71689310|NCT01763827|142894301|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.007|TWO_SIDED|95.0|2.23|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.23|0.007
71689311|NCT01763827|142894301|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|8.48|||<|0.001|TWO_SIDED|95.0|5.53|11.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||11.43|5.53|<0.001
71925825|NCT01241591|143372008|SUPERIORITY_OR_OTHER||Mean Difference|32.16|STANDARD_ERROR_OF_MEAN|4.41|||TWO_SIDED|95.0|23.51|40.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.81|23.51|
71925826|NCT01241591|143372008|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|1.91|STANDARD_ERROR_OF_MEAN|3.64|||TWO_SIDED|95.0|-5.22|9.05||||||Difference from Etanercept (Active-Etanercept)||9.05|-5.22|
71925827|NCT01241591|143372008|SUPERIORITY_OR_OTHER||Mean Difference|53.23|STANDARD_ERROR_OF_MEAN|4.3|||TWO_SIDED|95.0|44.81|61.65||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||61.65|44.81|
71925828|NCT01241591|143372009|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA and PASI75 response at Week 12.|Mean Difference|-19.29|STANDARD_ERROR_OF_MEAN|3.81|||TWO_SIDED|95.0|-26.75|-11.83||||||Difference from Etanercept (Active-Etanercept)||-11.83|-26.75|
71689312|NCT01763827|142894301|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|4.81||||0.013|TWO_SIDED|95.0|0.85|8.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.78|0.85|0.013
71689313|NCT01763827|142894301|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|3.81||||0.044|TWO_SIDED|95.0|-0.77|8.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline visit|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.39|-0.77|0.044
71689314|NCT01763827|142894302|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.91||||0.007|TWO_SIDED|95.0|1.67|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||10.16|1.67|0.007
71689315|NCT01763827|142894302|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|9.33|||<|0.001|TWO_SIDED|95.0|5.32|13.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||13.34|5.32|<0.001
71689316|NCT01763827|142894302|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|7.56||||0.013|TWO_SIDED|95.0|3.11|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||12.00|3.11|0.013
71689317|NCT01763827|142894302|SUPERIORITY_OR_OTHER_LEGACY||Median Treatment Difference|5.53||||0.044|TWO_SIDED|95.0|2.22|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.|||8.84|2.22|0.044
71689318|NCT02179047|142894388|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.002|TWO_SIDED||||||ANOVA|||||||0.002
71689319|NCT02179047|142894389|SUPERIORITY||Hazard Ratio (HR)|1.05|STANDARD_DEVIATION|0.005||0.002|TWO_SIDED|95.0|||||ANOVA|||||||0.002
71689320|NCT02179047|142894390|SUPERIORITY||Hazard Ratio (HR)|1.39|STANDARD_DEVIATION|0.005||0.001|TWO_SIDED||||||ANCOVA|||||||0.001
71689321|NCT01393522|142894391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1|TWO_SIDED||||||ANCOVA|||||||0.1
71689322|NCT01393522|142894391|SUPERIORITY_OR_OTHER_LEGACY|||||||0.88|TWO_SIDED||||||t-test, 2 sided|||||||0.88
71689323|NCT01393522|142894392|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
71925829|NCT01241591|143372009|SUPERIORITY_OR_OTHER||Mean Difference|33.91|STANDARD_ERROR_OF_MEAN|3.49|||TWO_SIDED|95.0|27.06|40.76||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.||40.76|27.06|
71925830|NCT01241591|143372009|NON_INFERIORITY_OR_EQUIVALENCE|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|4.83|STANDARD_ERROR_OF_MEAN|3.77|||TWO_SIDED|95.0|-2.57|12.23||||||Difference from Etanercept (Active-Etanercept)||12.23|-2.57|
71925831|NCT01241591|143372009|SUPERIORITY_OR_OTHER||Mean Difference|58.03|STANDARD_ERROR_OF_MEAN|3.46|||TWO_SIDED|95.0|51.25|64.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.||64.81|51.25|
71925832|NCT01945034|143372054|SUPERIORITY_OR_OTHER||LS Mean Difference|23.0||||0.19|TWO_SIDED|95.0|-11.49|57.56||p-value \<=0.05 for treatment effects|ANOVA|||The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||57.56|-11.49|0.190
71925833|NCT01945034|143372054|SUPERIORITY_OR_OTHER||LS Mean Difference|7.8||||0.633|TWO_SIDED|95.0|-24.2|39.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||39.70|-24.20|0.633
71925834|NCT01945034|143372054|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.436|TWO_SIDED|95.0|-53.87|23.3||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.||23.30|-53.87|0.436
71925835|NCT01945034|143372055|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|4.8||||0.426|TWO_SIDED|95.0|-6.98|16.49||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI\< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||16.49|-6.98|0.426
71689324|NCT01393522|142894393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|TWO_SIDED||||||ANCOVA|||||||0.75
71689325|NCT01393522|142894393|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|TWO_SIDED||||||t-test, 2 sided|||||||0.24
71689326|NCT01393522|142894394|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|TWO_SIDED||||||t-test, 2 sided|||||||0.16
71689327|NCT01393522|142894395|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41|TWO_SIDED||||||t-test, 2 sided|||||||0.41
71689328|NCT01393522|142894396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09|TWO_SIDED||||||t-test, 2 sided|||||||0.09
71689329|NCT01393522|142894397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.78|TWO_SIDED||||||t-test, 2 sided|||||||0.78
71689330|NCT03746405|142894399|SUPERIORITY||Mean Difference (Final Values)|1.15|||=|0.03|TWO_SIDED|||||Give the limited sample size, this p-value was not adjusted for multiple comparisons. The threshold for statistical significant was p \< 0.05|t-test, 2 sided|||Hypothesis: Active rTMS applied over the node in the medial prefrontal cortex the most strongly negatively connected to the right amygdala will decrease amygdala BOLD activation compared to sham rTMS||||= 0.03
71689331|NCT03479008|142894400|OTHER||||||<|0.0001||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||This presents the p value for the thigh comparison baseline to during stimulation||||<0.0001
71689332|NCT03479008|142894400|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This presents the p value for the calf comparisons between baseline and during stimulation.||||<0.0001
71689333|NCT03479008|142894400|OTHER||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||This statistical analysis presents the data for the biceps comparisons between baseline and during stimulation.||||<0.001
71689334|NCT03479008|142894401|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||The P value below applies to the VO2||||<0.0001
71689335|NCT03479008|142894401|SUPERIORITY||||||<|0.001|||||||post-hoc analysis|with Bonferroni correction||This p value applies to the VCO2||||<0.001
71689336|NCT03479008|142894402|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
71689337|NCT03479008|142894403|SUPERIORITY||||||<|0.0001|||||||post-hoc analysis|with Bonferroni correction||||||<0.0001
71925836|NCT01945034|143372055|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.0||||0.85|TWO_SIDED|95.0|-11.9|9.82||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.||9.82|-11.90|0.850
71925837|NCT01945034|143372055|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.8||||0.385|TWO_SIDED|95.0|-18.91|7.32||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.||7.32|-18.91|0.385
71925838|NCT01945034|143372056|SUPERIORITY_OR_OTHER||LS Mean Difference|10.0||||0.072|TWO_SIDED|95.0|-0.92|20.91||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||20.91|-0.92|0.072
71925839|NCT01945034|143372056|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.296|TWO_SIDED|95.0|-15.4|4.7||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.70|-15.40|0.296
71925840|NCT01945034|143372056|SUPERIORITY_OR_OTHER||LS Mean Difference|-15.3||||0.014|TWO_SIDED|95.0|-27.53|-3.16||p-value \<=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.||-3.16|-27.53|0.014
71925841|NCT01945034|143372057|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.305|TWO_SIDED|95.0|-0.1|0.3||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo||0.30|-0.10|0.305
71925842|NCT01945034|143372057|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.261|TWO_SIDED|95.0|-0.08|0.29||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.29|-0.08|0.261
71925843|NCT01945034|143372057|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.996|TWO_SIDED|95.0|-0.22|0.22||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.22|-0.22|0.996
71925844|NCT01945034|143372057|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.21|TWO_SIDED|95.0|-0.08|0.36||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.08|0.210
71925845|NCT01945034|143372057|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.556|TWO_SIDED|95.0|-0.14|0.27||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.27|-0.14|0.556
71689338|NCT03479008|142894404|SUPERIORITY|||||||0.094|||||||post-hoc analysis|with Bonferroni correction||||||0.094
71689339|NCT03479008|142894405|SUPERIORITY|||||||0.011||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for Muscle bellies of Soleus (SO)||||0.011
71689340|NCT03479008|142894405|SUPERIORITY|||||||0.012|||||||ANOVA|Statistical significance level was set at p \< 0.05 for all tests.||Comparison of Vibration to Baseline for tibialis anterior (TA)||||0.012
71689341|NCT03479008|142894405|SUPERIORITY|||||||0.003||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for gastrocnemius lateralis (GL)||||0.003
71689342|NCT03479008|142894405|SUPERIORITY||||||<|0.001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus medialis (VM)||||<0.001
71689343|NCT03479008|142894405|SUPERIORITY||||||<|0.0001||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for vastus lateralis (VL)||||<0.0001
71689344|NCT03479008|142894405|SUPERIORITY|||||||0.59||||||Statistical significance level was set at p \<0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for rectus femoris (RF)||||0.59
71689345|NCT03479008|142894405|SUPERIORITY|||||||0.86||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for semitendinosus (ST)||||0.86
71689346|NCT03479008|142894405|SUPERIORITY|||||||0.006||||||Statistical significance level was set at p \< 0.05 for all tests.|ANOVA|||Comparison of Vibration to Baseline for deltoideus medius||||0.006
71689347|NCT00412932|142894406|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.||||<0.0001
71689348|NCT00412932|142894407|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||One-sample t-test|||||||<0.0001
71689349|NCT00412932|142894408|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.|one-sample t-test|||||||<0.0001
71689350|NCT00412932|142894409|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||No multiplicity adjustments. The P-Value of \<0.0001 applies to both daytime and nighttime periods.|one-sample t-test|||||||<0.0001
71925846|NCT01945034|143372057|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.534|TWO_SIDED|95.0|-0.33|0.17||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.||0.17|-0.33|0.534
71925847|NCT01945034|143372058|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.354|TWO_SIDED|95.0|-0.27|0.1||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.10|-0.27|0.354
71925848|NCT01945034|143372058|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.237|TWO_SIDED|95.0|-0.28|0.07||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.07|-0.28|0.237
71925849|NCT01945034|143372058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.871|TWO_SIDED|95.0|-0.23|0.19||p-value \<=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.19|-0.23|0.871
71925850|NCT01945034|143372058|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.05|TWO_SIDED|95.0|-0.43|0.0||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.00|-0.43|0.050
71925851|NCT01945034|143372058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.64|TWO_SIDED|95.0|-0.25|0.15||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.25|0.640
71925852|NCT01945034|143372058|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.18|TWO_SIDED|95.0|-0.08|0.41||p-value \<=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.||0.41|-0.08|0.180
71925853|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.771|TWO_SIDED|95.0|-0.38|0.51|||ANOVA|||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.51|-0.38|0.771
71925854|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.022|TWO_SIDED|95.0|-0.88|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-0.07|-0.88|0.022
71925855|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.032|TWO_SIDED|95.0|-1.03|-0.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.05|-1.03|0.032
71925856|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.72|TWO_SIDED|95.0|-0.38|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.38|0.720
71925857|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.194|TWO_SIDED|95.0|-0.71|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.15|-0.71|0.194
71925858|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.163|TWO_SIDED|95.0|-0.89|0.15|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.15|-0.89|0.163
71925859|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.644|TWO_SIDED|95.0|-0.4|0.64|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.64|-0.40|0.644
71925860|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.129|TWO_SIDED|95.0|-0.85|0.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.11|-0.85|0.129
71925861|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.096|TWO_SIDED|95.0|-1.07|0.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.09|-1.07|0.096
71689351|NCT01703169|142894413|OTHER||||||||||||||||||The proportion of platelet response in a previous study (PMID:22762314) was 0.36 (9/25). The null hypothesis of no difference between the platelet response rate in this study and that of the previous study was tested using a two-sided exact test of binomial proportions. A p-value of 0.40 was obtained. The threshold for significance was 0.05.|||
71689352|NCT00947310|142894459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.45||||0.01|TWO_SIDED|95.0|0.24|0.85|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.85|0.24|0.01
71689353|NCT00947310|142894459|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56||||0.06|TWO_SIDED|95.0|0.3|1.02|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||1.02|0.30|0.06
71689354|NCT00947310|142894460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.32||||0.39|TWO_SIDED|95.0|0.71|2.47|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||2.47|0.71|0.39
71689355|NCT00947310|142894460|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.58|2.05|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||2.05|0.58|0.80
71689356|NCT00947310|142894461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.13|0.34|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1||0.34|0.13|<0.001
71689357|NCT00947310|142894461|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24|||<|0.001|TWO_SIDED|95.0|0.15|0.4|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1||0.40|0.15|<0.001
71689358|NCT00547248|142894462|NON_INFERIORITY|Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature \> 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar.|Difference in percentage|0.89|||||TWO_SIDED|95.0|-4.82|5.59|||Philips' statistical test|||||5.59|-4.82|
71689359|NCT00534248|142894490|SUPERIORITY_OR_OTHER||point estimate|0.698|||<|0.001|TWO_SIDED|95.0|0.541|0.806|||Conditional Exact Method||The point estimate was for vaccine efficacy with respect to incidence of HZ.|Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.||.806|.541|<.001
71689360|NCT00534248|142894491|SUPERIORITY_OR_OTHER||geometric mean titre ratio|2.3|||<|0.001|TWO_SIDED|95.0|2.2|2.4|||linear mixed longitudinal analysis model|||||2.4|2.2|<.001
71689361|NCT00534248|142894492|SUPERIORITY_OR_OTHER||Relative Risk|1.133|||||TWO_SIDED|95.0|0.805|1.595||||||Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.||1.595|.805|
71689362|NCT02259400|142894513|NON_INFERIORITY_OR_EQUIVALENCE|For the calculation of sample size we used the duration of ventilation as the main primary outcome. As no basic data are available for this population, we were able to retrieve from the database of our two NICUs the duration of ventilation on NIV. We assumed a difference of 24-h between the two groups in the duration of NIV as clinically relevant. We used a confidence level α=0.05; the power level desired was 0.80 and consequently we needed 62 patients for each group.|||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.05
71689363|NCT02964338|142894560|OTHER||Least square (LS) mean difference|3.5||||0.2741|TWO_SIDED|95.0|-2.8|9.82||Threshold for significance at 0.05 level.|ANCOVA|||||9.82|-2.80|0.2741
71689364|NCT02964338|142894560|OTHER||LS mean difference|-3.3||||0.3047|TWO_SIDED|95.0|-9.59|3.01||Threshold for significance at 0.05 level.|ANCOVA|||||3.01|-9.59|0.3047
71689365|NCT00112918|142894573|SUPERIORITY_OR_OTHER|||||||0.2024||95.0|||||Closed test procedure|||Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.||||0.2024
71689366|NCT05076604|142894589|SUPERIORITY|||||||0.354|||||||t-test, 2 sided|||Intraoperative packed red blood cell transfusion||||0.354
71689367|NCT05076604|142894589|SUPERIORITY|||||||0.314|||||||t-test, 2 sided|||Postoperative red blood cell transfusion||||0.314
71689368|NCT03258645|142894591|OTHER||||||<|0.001|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of National Institute of Health Stroke Scale (NIHSS) score at index date was applied.||||< 0.001
71689369|NCT03258645|142894592|OTHER|||||||0.01|||||||Regression, Linear|||Univariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of Modified Rankin Scale (mRS) at index date was applied.||||0.01
71689370|NCT03258645|142894593|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.13||||0.016|TWO_SIDED|95.0|1.02|1.25|||Regression, Linear|Relation between age and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.25|1.02|0.016
71689371|NCT03258645|142894594|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.12||||0.002|TWO_SIDED|95.0|1.04|1.21|||Regression, Linear|Relation between Diastolic blood pressure (DBP) and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.04|0.002
71689372|NCT03258645|142894595|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|1.1||||0.04|TWO_SIDED|95.0|1.0|1.21|||Regression, Linear|Relation between CHA2DS2-VASc and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.21|1.00|0.04
71689373|NCT03258645|142894596|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.9||||0.051|TWO_SIDED|95.0|0.45|1.0|||Regression, Linear|Relation between HAS-BLED and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||1.00|0.45|0.051
71689374|NCT03258645|142894597|OTHER|CHA2DS2-VASc is the Congestive heart failure, Hypertension, Age (\> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category score. HAS-BLED is the Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol Score.|Odds Ratio (OR)|0.91||||0.026|TWO_SIDED|95.0|0.9|0.93|||Regression, Linear|Relation between History/Predisposition To Bleeding and dabigatran initiation time was reported.||Multivariate linear regression with the continuous dependent variable of time-to-initiation for dabigatran in days and independent variable of age, Diastolic blood pressure (DBP), CHA2DS2-VASc, HAS-BLED, and History/Predisposition To Bleeding at index date was applied.||0.93|0.9|0.026
71689375|NCT01704755|142894602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.||96.1|87.6|
71689376|NCT01704755|142894602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|91.8|||||TWO_SIDED|97.5|87.6|96.1||||||The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.||96.1|87.6|
71689377|NCT01704755|142894602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
71689378|NCT01704755|142894602|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|96.5|||||TWO_SIDED|97.5|93.4|99.7||||||||99.7|93.4|
71689379|NCT01704755|142894603|SUPERIORITY_OR_OTHER_LEGACY|||||||0.051|TWO_SIDED||||||Regression, Logistic|||To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.||||0.051
71689380|NCT01639703|142894657|OTHER||Odds Ratio (OR)|0.76||||0.2476|TWO_SIDED|95.0|0.47|1.21|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.21|0.47|0.2476
71925862|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.5|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.57|-0.50|0.905
71925863|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.279|TWO_SIDED|95.0|-0.77|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.77|0.279
71925864|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.315|TWO_SIDED|95.0|-0.9|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.29|-0.90|0.315
71925865|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.203|TWO_SIDED|95.0|-0.19|0.91|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.91|-0.19|0.203
71689381|NCT01639703|142894658|OTHER||Odds Ratio (OR)|1.13||||0.5354|TWO_SIDED|95.0|0.77|1.66|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.66|0.77|0.5354
71925866|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.207|TWO_SIDED|95.0|-0.83|0.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.18|-0.83|0.207
71925867|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.03|TWO_SIDED|95.0|-1.3|-0.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.07|-1.30|0.030
71925868|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.372|TWO_SIDED|95.0|-0.32|0.84|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.84|-0.32|0.372
71925869|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.532|TWO_SIDED|95.0|-0.7|0.36|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.36|-0.70|0.532
71925870|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.189|TWO_SIDED|95.0|-1.08|0.21|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.21|-1.08|0.189
71925871|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.264|TWO_SIDED|95.0|-0.24|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.24|0.264
71925872|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.26|TWO_SIDED|95.0|-0.81|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.81|0.260
71925873|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.054|TWO_SIDED|95.0|-1.23|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.23|0.054
71925874|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.456|TWO_SIDED|95.0|-0.37|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.37|0.456
71925875|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.639|TWO_SIDED|95.0|-0.42|0.68|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.42|0.639
71925876|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.78|TWO_SIDED|95.0|-0.75|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.75|0.780
71925877|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.071|TWO_SIDED|95.0|-0.04|1.07|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.07|-0.04|0.071
71925878|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.468|TWO_SIDED|95.0|-0.7|0.32|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.32|-0.70|0.468
71925879|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.027|TWO_SIDED|95.0|-1.33|-0.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.08|-1.33|0.027
71925880|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.107|TWO_SIDED|95.0|-0.11|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.11|0.107
71925881|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.947|TWO_SIDED|95.0|-0.57|0.53|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.57|0.947
71925882|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.134|TWO_SIDED|95.0|-1.18|0.16|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.16|-1.18|0.134
71689382|NCT01639703|142894659|OTHER||Odds Ratio (OR)|0.9||||0.3487|TWO_SIDED|95.0|0.71|1.13|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.13|0.71|0.3487
71689383|NCT01639703|142894660|OTHER||Odds Ratio (OR)|1.08||||0.4195|TWO_SIDED|95.0|0.9|1.29|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.29|0.90|0.4195
71689384|NCT01639703|142894661|OTHER||Odds Ratio (OR)|0.9||||0.7127|TWO_SIDED|95.0|0.53|1.54|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||1.54|0.53|0.7127
71689385|NCT01639703|142894662|OTHER||Odds Ratio (OR)|1.41||||0.1753|TWO_SIDED|95.0|0.86|2.31|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and \>50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.||2.31|0.86|0.1753
71689386|NCT00551525|142894712|SUPERIORITY_OR_OTHER||||||<|0.001||||||Significance level 0.05, two-sided test|binomial proportion|||||||<0.001
71689387|NCT00551525|142894715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.984|||||TWO_SIDED|95.0|0.91|1.063||||||Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and Gleason score (\<8 vs. 8-10\[reference level\]).||1.063|0.910|
71689388|NCT00551525|142894715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02|||||TWO_SIDED|95.0|0.89|1.169||||||Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), Gleason score (\<8 vs. 8-10\[reference level\]), and age.||1.169|0.890|
71925883|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.017|TWO_SIDED|95.0|0.12|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.12|0.017
71925884|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.715|TWO_SIDED|95.0|-0.6|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.41|-0.60|0.715
71925885|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.015|TWO_SIDED|95.0|-1.39|-0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.15|-1.39|0.015
71925886|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.027|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.027
71925887|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.66|TWO_SIDED|95.0|-0.42|0.65|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.65|-0.42|0.660
71689389|NCT00551525|142894715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.307|||||TWO_SIDED|95.0|0.364|4.697||||||Modeling the association of clinical T-stage (pT2 vs. pT3 \[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (\<8 vs. 8-10\[reference level\]), and age.||4.697|0.364|
71689390|NCT00551525|142894715|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.659|||||TWO_SIDED|95.0|0.217|2.006||||||Modeling the association of Gleason score (\<8 vs. 8-10\[reference level\]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 \[reference level\]), baseline PSA, and age.||2.006|0.217|
71689391|NCT04676724|142894751|OTHER||Difference in SVR Rate|-3.0|||||TWO_SIDED|95.0|-29.0|11.0|||||The point estimate of SVR and its 95% highest posterior density Credible Interval (CI) are estimated from a Bayesian model that incorporates the analysis stratification factors and treatment arm.|||11|-29|
71689392|NCT01150903|142894752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
71689393|NCT01150903|142894753|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||Chi-square test was used to calculate p-value.||||<0.001
71689394|NCT04274075|142894776|OTHER||Geometric Mean Ratio|1.03|||||TWO_SIDED|90.0|0.945|1.12|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.12|0.945|
71689395|NCT04274075|142894776|OTHER||Geometric Mean Ratio|0.79|||||TWO_SIDED|90.0|0.726|0.859|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.859|0.726|
71689396|NCT04274075|142894777|OTHER||Median Difference (Net)|0.525|||||TWO_SIDED|90.0|-0.225|1.5|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.50|-0.225|
71925888|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.107|TWO_SIDED|95.0|-1.18|0.11|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.11|-1.18|0.107
71925889|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|0.10|0.020
71925890|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.749|TWO_SIDED|95.0|-0.55|0.4|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.55|0.749
71925891|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.019|TWO_SIDED|95.0|-1.27|-0.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.12|-1.27|0.019
71925892|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.163|TWO_SIDED|95.0|-0.16|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.16|0.163
71925893|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.727|TWO_SIDED|95.0|-0.43|0.61|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.61|-0.43|0.727
71925894|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.336|TWO_SIDED|95.0|-0.94|0.32|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.32|-0.94|0.336
71925895|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.174|TWO_SIDED|95.0|-0.16|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.16|0.174
71925896|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.277|TWO_SIDED|95.0|-0.73|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.21|-0.73|0.277
71925897|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.035|TWO_SIDED|95.0|-1.19|-0.04|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.04|-1.19|0.035
71925898|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.858|TWO_SIDED|95.0|-0.5|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.50|0.858
71925899|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.724|TWO_SIDED|95.0|-0.6|0.42|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.60|0.724
71925900|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.651|TWO_SIDED|95.0|-0.76|0.48|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.48|-0.76|0.651
71925901|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.059|TWO_SIDED|95.0|-0.02|1.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.05|-0.02|0.059
71925902|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.766|TWO_SIDED|95.0|-0.57|0.42|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.42|-0.57|0.766
71925903|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.053|TWO_SIDED|95.0|-1.19|0.01|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.01|-1.19|0.053
71925904|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.212|TWO_SIDED|95.0|-0.21|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.21|0.212
71925905|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.911|TWO_SIDED|95.0|-0.49|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.55|-0.49|0.911
71925906|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.305|TWO_SIDED|95.0|-0.96|0.3|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.30|-0.96|0.305
71689397|NCT04274075|142894777|OTHER||Median Difference (Net)|1.98|||||TWO_SIDED|90.0|1.26|2.45|||||The Hodges-Lehmann estimate of median difference was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||2.45|1.26|
71689398|NCT04274075|142894780|OTHER||Geometric Mean Ratio|0.971|||||TWO_SIDED|90.0|0.903|1.04|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.04|0.903|
71689399|NCT04274075|142894780|OTHER||Geometric Mean Ratio|0.919|||||TWO_SIDED|90.0|0.855|0.988|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.988|0.855|
71689400|NCT04274075|142894781|OTHER||Geometric Mean Ratio|0.975|||||TWO_SIDED|90.0|0.908|1.05|||||The geometric mean ratio was calculated as Treatment B versus Treatment A.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||1.05|0.908|
71689401|NCT04274075|142894781|OTHER||Geometric Mean Ratio|0.918|||||TWO_SIDED|90.0|0.856|0.985|||||The geometric mean ratio was calculated as Treatment C versus Treatment B.|The sample size chosen for this study was based upon precedent set by other PK studies of similar nature and was not based on power calculations.||0.985|0.856|
71689402|NCT00099632|142894796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV||||0.37
71689403|NCT00099632|142894796|SUPERIORITY_OR_OTHER_LEGACY|||||||0.091||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV||||0.091
71689404|NCT04388176|142894809|EQUIVALENCE|Differences in treatment groups in the primary endpoint (log (AUC)) was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0146|||=|0.3801|TWO_SIDED|90.0|0.9859|1.0442|||ANCOVA|||||1.0442|0.9859|=0.3801
71925907|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.075|TWO_SIDED|95.0|-0.05|1.02|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.05|0.075
71925908|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.684|TWO_SIDED|95.0|-0.39|0.6|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.60|-0.39|0.684
71689405|NCT04388176|142894810|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|1.0346|||=|0.0356|TWO_SIDED|90.0|1.0086|1.0613|||ANCOVA|||||1.0613|1.0086|=0.0356
71689406|NCT04388176|142894811|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Difference in least square means|-0.4991|||=|0.0154|TWO_SIDED|90.0|-0.8234|-0.1749|||ANCOVA|||Analysis at the 10 min point||-0.1749|-0.8234|=0.0154
71689407|NCT04388176|142894812|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1.|Ratio in least square means|0.8301|||=|0.282|TWO_SIDED|90.0|0.6206|1.1102|||ANCOVA|||||1.1102|0.6206|=0.282
71689408|NCT04388176|142894813|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.3989|||=|0.3722|TWO_SIDED|90.0|-1.1718|0.3739|||ANCOVA|||||0.3739|-1.1718|=0.3722
71689409|NCT04388176|142894814|EQUIVALENCE|Differences between treatment groups was to be detected with a power of 90% and alpha=0.1|Difference in least square means|-0.109|||=|0.4982|TWO_SIDED|90.0|-0.4074|0.1895|||ANCOVA|||Analysis of capillaroscopy before cold||0.1895|-0.4074|=0.4982
71689410|NCT04388176|142894814|EQUIVALENCE|A difference between treatment groups was detected with a power of 90% and alpha=0.1|Difference in least square means|-0.0637|||=|0.6219|TWO_SIDED|90.0|-0.3037|0.1763|||ANCOVA|||Analysis of capillaroscopy post recovery||0.1763|-0.3037|=0.6219
71689411|NCT00282152|142894844|NON_INFERIORITY|Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.||||||0.968|||||||Log Rank|||||||0.968
71689412|NCT00282152|142894845|OTHER|||||||0.4|||||||t-test, 2 sided|||Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.||||0.40
71689413|NCT01124370|142894856|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The test was conducted using a 0.05 level of significance.|t-test, 2 sided|||The null hypothesis was that there would be no change in AHI from baseline.||||<.001
71761184|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0186|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||-0.0|-0.5|0.0186
71925909|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.208|TWO_SIDED|95.0|-0.98|0.21|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.21|-0.98|0.208
71925910|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.27|0.85|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.85|-0.27|0.304
71925911|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.356|TWO_SIDED|95.0|-0.27|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.27|0.356
71925912|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.876|TWO_SIDED|95.0|-0.67|0.58|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.58|-0.67|0.876
71925913|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.02|TWO_SIDED|95.0|0.1|1.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.15|0.10|0.020
71925914|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.94|TWO_SIDED|95.0|-0.5|0.47|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.47|-0.50|0.940
71925915|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.6||||0.032|TWO_SIDED|95.0|-1.23|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.23|0.032
71925916|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.206|TWO_SIDED|95.0|-0.21|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.21|0.206
71925917|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.31|TWO_SIDED|95.0|-0.26|0.81|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.81|-0.26|0.310
71925918|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.771|TWO_SIDED|95.0|-0.74|0.55|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.55|-0.74|0.771
71925919|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.24|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.24|0.13|0.016
71925920|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.905|TWO_SIDED|95.0|-0.48|0.54|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.54|-0.48|0.905
71925921|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.039|TWO_SIDED|95.0|-1.28|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.28|0.039
71925922|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.276|TWO_SIDED|95.0|-0.27|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.27|0.276
71925923|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.343|TWO_SIDED|95.0|-0.29|0.82|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.82|-0.29|0.343
71925924|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.849|TWO_SIDED|95.0|-0.73|0.6|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.60|-0.73|0.849
71925925|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.009|TWO_SIDED|95.0|0.19|1.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.29|0.19|0.009
71761185|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.4|-0.9|<0.0001
71925926|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.763|TWO_SIDED|95.0|-0.58|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.43|-0.58|0.763
71925927|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.8||||0.01|TWO_SIDED|95.0|-1.43|-0.2|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.20|-1.43|0.010
71761186|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0407|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||-0.0|-0.6|0.0407
71925928|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.105|TWO_SIDED|95.0|-0.1|1.09|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.10|0.105
71925929|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.533|TWO_SIDED|95.0|-0.38|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.38|0.533
71925930|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.348|TWO_SIDED|95.0|-0.99|0.35|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.35|-0.99|0.348
71925931|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.016|TWO_SIDED|95.0|0.13|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.13|0.016
71925932|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.483|TWO_SIDED|95.0|-0.69|0.33|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.33|-0.69|0.483
71925933|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.9||||0.006|TWO_SIDED|95.0|-1.47|-0.25|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.25|-1.47|0.006
71925934|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.177|TWO_SIDED|95.0|-0.19|1.0|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.00|-0.19|0.177
71925935|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.586|TWO_SIDED|95.0|-0.4|0.7|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.70|-0.40|0.586
71925936|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.448|TWO_SIDED|95.0|-0.92|0.41|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.41|-0.92|0.448
71925937|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.043|TWO_SIDED|95.0|0.02|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|0.02|0.043
71925938|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.688|TWO_SIDED|95.0|-0.59|0.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.39|-0.59|0.688
71925939|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.032|TWO_SIDED|95.0|-1.25|-0.06|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.06|-1.25|0.032
71689414|NCT02182830|142894863|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint|Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.2||0.0002|TWO_SIDED|95.0|-1.18|-0.38|||Mixed Models Analysis||Empagliflozin minus Placebo|"MMRM model : HbA1c baseline, treatment, renal function, pre-treatment with metformin, visit, visit by treatment interaction, and HbA1c baseline by treatment interaction. Treatment, renal function, pre-treatment with metformin, visit, and visit by treatment interaction were fixed classification effects, and HbA1c baseline was a linear covariate. The interaction visit by HbA1c baseline interaction was based on the linear covariate HbA1c baseline."||-0.38|-1.18|0.0002
71689415|NCT02182830|142894864|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.21|STANDARD_ERROR_OF_MEAN|2.04||0.0117|TWO_SIDED|95.0|-9.24|-1.18|||ANCOVA||Empagliflozin minus Placebo|"change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-1.18|-9.24|0.0117
71689416|NCT02182830|142894865|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.99|STANDARD_ERROR_OF_MEAN|2.62||0.0237|TWO_SIDED|95.0|-11.16|-0.81|||ANCOVA||Empagliflozin minus Placebo|"ANCOVA mode:~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."||-0.81|-11.16|0.0237
71689417|NCT02182830|142894866|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-1.23|STANDARD_ERROR_OF_MEAN|0.59||0.0382|TWO_SIDED|95.0|-2.39|-0.07|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||-0.07|-2.39|0.0382
71689418|NCT02182830|142894867|SUPERIORITY|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-4.04|STANDARD_ERROR_OF_MEAN|2.59||0.1215|TWO_SIDED|95.0|-9.16|1.09|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.||1.09|-9.16|0.1215
71689419|NCT02182830|142894868|SUPERIORITY||Adjusted mean difference|-8.39|STANDARD_ERROR_OF_MEAN|2.69||0.0025|TWO_SIDED|95.0|-13.74|-3.04|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-3.04|-13.74|0.0025
71689420|NCT02182830|142894869|SUPERIORITY||Adjusted mean difference|-3.43|STANDARD_ERROR_OF_MEAN|1.25||0.0069|TWO_SIDED|95.0|-5.9|-0.96|||ANCOVA||Empagliflozin minus Placebo|The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.||-0.96|-5.90|0.0069
71689421|NCT02182830|142894870|SUPERIORITY||Adjusted mean difference|-4.91|STANDARD_ERROR_OF_MEAN|1.74||0.0058|TWO_SIDED|95.0|-8.35|-1.46|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.46|-8.35|0.0058
71689422|NCT02182830|142894871|SUPERIORITY||Adjusted mean difference|-7.43|STANDARD_ERROR_OF_MEAN|2.5||0.0036|TWO_SIDED|95.0|-12.37|-2.48|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-2.48|-12.37|0.0036
71689423|NCT02182830|142894872|SUPERIORITY||Adjusted mean difference|-1.84|STANDARD_ERROR_OF_MEAN|1.56||0.2402|TWO_SIDED|95.0|-4.93|1.25|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||1.25|-4.93|0.2402
71689424|NCT02182830|142894873|SUPERIORITY||Adjusted mean difference|-4.25|STANDARD_ERROR_OF_MEAN|1.49||0.0053|TWO_SIDED|95.0|-7.21|-1.29|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.||-1.29|-7.21|0.0053
71689425|NCT04672044|142894885|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71689426|NCT03268005|142894886|NON_INFERIORITY|The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.|Treatment difference|-0.04||||0.31|TWO_SIDED|95.0|-0.11|0.03|||ANOVA||Faster aspart-NovoRapid|Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.||0.03|-0.11|0.310
71689427|NCT00792116|142894949|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
71689428|NCT00792116|142894950|NON_INFERIORITY_OR_EQUIVALENCE|||||||0.05||95.0|||||ANCOVA|Repeated Measures||||||.05
71689429|NCT01490840|142895022|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 90 in each group would have 80% power to detect a difference in means of 3.8, assuming that the common standard deviation is 9.05, using a two group t-test with a 0.05 2-sided significance level.|Mean Difference (Net)|-1.47||||0.4579|TWO_SIDED|95.0|-5.39|2.44|||ANCOVA|||||2.44|-5.39|0.4579
71689430|NCT00905567|142895042|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|93.01||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
71925940|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.179|TWO_SIDED|95.0|-0.19|0.99|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.99|-0.19|0.179
71925941|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.609|TWO_SIDED|95.0|-0.4|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.40|0.609
71925942|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.435|TWO_SIDED|95.0|-0.92|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.40|-0.92|0.435
71925943|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.023|TWO_SIDED|95.0|0.1|1.26|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.26|0.10|0.023
71689431|NCT00905567|142895043|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.62||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
71689432|NCT00905567|142895044|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.43||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.|||||
71689433|NCT02542397|142895045|SUPERIORITY|"It has been reported that, based on the Edmonton Symptom Assessment Scale (ESAS) pain scale, about 30% of cancer patients receiving standard of care pain management experienced \>= 2-point improvement in pain score between visits \[Ref\].~Ref: Scharpf, J., et al., The role of pain in head and neck cancer recurrence and survivorship. Arch Otolaryngol Head Neck Surg, 2009. 135(8): p. 789-94."|Exact binomial proportion|0.5556|||<|0.0001|TWO_SIDED|95.0|0.414|0.6908||The a priori threshold for statistical significance was alpha = 0.10.|Exact binomial test of proportions|||A single-stage design was used to test the hypothesis that the pain improvement rate, assessed by the Edmonton Symptom Assessment Scale, is \<= 0.30. Our study targeted enrollment of 71 evaluable subjects for the final analysis; 54 subjects met the criteria at study closure. Assuming a one-sided alpha=0.10 significance level, 71 evaluable subjects would provide approximately 90% power to reject the null hypothesis (based on an exact binomial test) assuming the true pain improvement rate is 0.45.||.6908|.4140|<0.0001
71689434|NCT02362191|142895051|OTHER|||||||0.758||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.758
71689435|NCT02362191|142895052|OTHER|||||||0.4||||||The threshold for statistical significance is 0.05.|t-test, 2 sided|||||||0.40
71689436|NCT01473940|142895059|OTHER|||||||||||||P-Value not used||||A 3 + 3 enrollment design was adopted to monitor safety and determine the MTD based on DLTs obsesved. The MTD is the highest dose at which 0 of 3 or 1 of 6 DLTs are detected. The MTD is exceeded if 2 of 3 or 2 of 6 DLTs are detected. There will be no dose escalation within a cohort.|The number of DLTs seen at each cohort were used to determine the MTD for the expansion cohort. The MTD was determined to be Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg|||
71925944|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.987|TWO_SIDED|95.0|-0.54|0.53|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.53|-0.54|0.987
71925945|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.7||||0.04|TWO_SIDED|95.0|-1.33|-0.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.03|-1.33|0.040
71689437|NCT00435461|142895083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
71689438|NCT00435461|142895083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.2|-0.7|||ANCOVA|||||-0.7|-1.2|<0.001
71925946|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.319|TWO_SIDED|95.0|-0.31|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.31|0.319
71689439|NCT00435461|142895083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.14||0.816|TWO_SIDED|95.0|-0.3|0.2|||ANCOVA|||||0.2|-0.3|0.816
71689440|NCT00435461|142895084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.9|||ANCOVA|||||-0.9|-1.6|<0.001
71689441|NCT00435461|142895084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||||-0.7|-1.4|<0.001
71689442|NCT00435461|142895084|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
71689443|NCT00435461|142895085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||ANCOVA|||||-0.7|-1.5|<0.001
71689444|NCT00435461|142895085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||ANCOVA|||||-0.4|-1.2|<0.001
71689445|NCT00435461|142895085|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.19||0.136|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||||0.1|-0.7|0.136
71689446|NCT00435461|142895086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|||||-0.8|-1.6|<0.001
71689447|NCT00435461|142895086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.3|-0.6|||ANCOVA|||||-0.6|-1.3|<0.001
71689448|NCT00435461|142895086|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.136|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||||0.1|-0.6|0.136
71689449|NCT00435461|142895087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||||-0.2|-0.8|0.001
71689450|NCT00435461|142895087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
71689451|NCT00435461|142895087|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
71689452|NCT00435461|142895088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.007|TWO_SIDED|95.0|-0.7|-0.1|||ANCOVA|||||-0.1|-0.7|0.007
71689453|NCT00435461|142895088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
71689454|NCT00435461|142895088|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.106
71689455|NCT00435461|142895089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.003|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||||-0.2|-0.7|0.003
71925947|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.712|TWO_SIDED|95.0|-0.47|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.69|-0.47|0.712
71925948|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.557|TWO_SIDED|95.0|-0.91|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.49|-0.91|0.557
71925949|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.015|TWO_SIDED|95.0|0.14|1.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.28|0.14|0.015
71925950|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.326|TWO_SIDED|95.0|-0.26|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.26|0.326
71689456|NCT00435461|142895089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.15||0.286|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|||||0.1|-0.5|0.286
71689457|NCT00435461|142895089|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.106|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||||0|-0.6|0.106
71689458|NCT00435461|142895090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.7|-1.0|||ANCOVA|||Pre-dose iTNSS||-1|-1.7|<0.001
71925951|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.167|TWO_SIDED|95.0|-1.08|0.19|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.19|-1.08|0.167
71925952|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.35|TWO_SIDED|95.0|-0.33|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.33|0.350
71925953|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.235|TWO_SIDED|95.0|-0.23|0.93|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-0.23|0.235
71925954|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.881|TWO_SIDED|95.0|-0.65|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.76|-0.65|0.881
71925955|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.036|TWO_SIDED|95.0|0.04|1.16|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.16|0.04|0.036
71925956|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.656|TWO_SIDED|95.0|-0.4|0.63|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.63|-0.40|0.656
71925957|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.13|TWO_SIDED|95.0|-1.11|0.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.14|-1.11|0.130
71925958|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.304|TWO_SIDED|95.0|-0.3|0.95|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.95|-0.30|0.304
71925959|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.491|TWO_SIDED|95.0|-0.37|0.78|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.78|-0.37|0.491
71925960|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.82|0.57|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.57|-0.82|0.726
71925961|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.029|TWO_SIDED|95.0|0.07|1.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.23|0.07|0.029
71925962|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.585|TWO_SIDED|95.0|-0.39|0.68|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.68|-0.39|0.585
71925963|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.131|TWO_SIDED|95.0|-1.15|0.15|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.15|-1.15|0.131
71925964|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.215|TWO_SIDED|95.0|-0.24|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.04|-0.24|0.215
71925965|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.244|TWO_SIDED|95.0|-0.24|0.94|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.24|0.244
71925966|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.885|TWO_SIDED|95.0|-0.76|0.66|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.66|-0.76|0.885
71925967|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.13|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.04|0.067
71925968|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.5|TWO_SIDED|95.0|-0.35|0.73|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.35|0.500
71925969|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.276|TWO_SIDED|95.0|-1.02|0.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.29|-1.02|0.276
71925970|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.413|TWO_SIDED|95.0|-0.38|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.38|0.413
71925971|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.448|TWO_SIDED|95.0|-0.37|0.83|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.83|-0.37|0.448
71925972|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.917|TWO_SIDED|95.0|-0.76|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.76|0.917
71925973|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.132|TWO_SIDED|95.0|-0.13|1.03|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.03|-0.13|0.132
71925974|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.505|TWO_SIDED|95.0|-0.35|0.72|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.72|-0.35|0.505
71925975|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.422|TWO_SIDED|95.0|-0.92|0.38|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.38|-0.92|0.422
71925976|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.747|TWO_SIDED|95.0|-0.54|0.76|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.76|-0.54|0.747
71925977|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.386|TWO_SIDED|95.0|-0.34|0.87|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.34|0.386
71925978|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.668|TWO_SIDED|95.0|-0.57|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.89|-0.57|0.668
71925979|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.099|TWO_SIDED|95.0|-0.09|1.08|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.08|-0.09|0.099
71925980|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.365|TWO_SIDED|95.0|-0.29|0.79|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.79|-0.29|0.365
71925981|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.463|TWO_SIDED|95.0|-0.9|0.41|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.41|-0.90|0.463
71925982|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.845|TWO_SIDED|95.0|-0.6|0.73|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.73|-0.60|0.845
71925983|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.199|TWO_SIDED|95.0|-0.21|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.21|0.199
71925984|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.375|TWO_SIDED|95.0|-0.41|1.08|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.08|-0.41|0.375
71925985|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7||||0.028|TWO_SIDED|95.0|0.07|1.27|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.27|0.07|0.028
71925986|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.188|TWO_SIDED|95.0|-0.18|0.92|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.92|-0.18|0.188
71925987|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.375|TWO_SIDED|95.0|-0.97|0.37|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.37|-0.97|0.375
71925988|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.552|TWO_SIDED|95.0|-0.47|0.89|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.89|-0.47|0.552
71925989|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.126|TWO_SIDED|95.0|-0.14|1.12|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.12|-0.14|0.126
71925990|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.46|TWO_SIDED|95.0|-0.47|1.05|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.05|-0.47|0.460
71925991|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.095|TWO_SIDED|95.0|-0.09|1.09|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.09|-0.09|0.095
71925992|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.146|TWO_SIDED|95.0|-0.14|0.94|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.94|-0.14|0.146
71925993|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.769|TWO_SIDED|95.0|-0.75|0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.56|-0.75|0.769
71925994|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.405|TWO_SIDED|95.0|-0.39|0.96|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.96|-0.39|0.405
71925995|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6||||0.073|TWO_SIDED|95.0|-0.05|1.2|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.20|-0.05|0.073
71925996|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.458|TWO_SIDED|95.0|-0.47|1.04|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||1.04|-0.47|0.458
71925997|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8||||0.009|TWO_SIDED|95.0|0.2|1.39|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.39|0.20|0.009
71925998|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.209|TWO_SIDED|95.0|-0.2|0.9|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.90|-0.20|0.209
71925999|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.193|TWO_SIDED|95.0|-1.11|0.22|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.22|-1.11|0.193
71926000|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.149|TWO_SIDED|95.0|-0.18|1.18|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.18|-0.18|0.149
71926001|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.4||||0.186|TWO_SIDED|95.0|-0.21|1.06|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.06|-0.21|0.186
71926002|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.845|TWO_SIDED|95.0|-0.84|0.69|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.69|-0.84|0.845
71926003|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.067|TWO_SIDED|95.0|-0.04|1.14|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.14|-0.04|0.067
71926004|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.242|TWO_SIDED|95.0|-0.22|0.87|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.87|-0.22|0.242
71926005|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2||||0.498|TWO_SIDED|95.0|-0.88|0.43|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||0.43|-0.88|0.498
71926006|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.3||||0.33|TWO_SIDED|95.0|-0.34|1.02|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.02|-0.34|0.330
71926007|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.5||||0.124|TWO_SIDED|95.0|-0.14|1.13|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||1.13|-0.14|0.124
71926008|NCT01945034|143372059|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.687|TWO_SIDED|95.0|-0.61|0.92|||ANOVA|p-value \<=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||0.92|-0.61|0.687
71926009|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|2.0||||0.166|TWO_SIDED|95.0|-0.85|4.95|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.95|-0.85|0.166
71926010|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.7||||0.199|TWO_SIDED|95.0|-4.42|0.93|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.93|-4.42|0.199
71926011|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.8||||0.022|TWO_SIDED|95.0|-7.04|-0.56|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-0.56|-7.04|0.022
71926012|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.26|TWO_SIDED|95.0|-1.3|4.79|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||4.79|-1.30|0.260
71926013|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.5||||0.729|TWO_SIDED|95.0|-3.31|2.32|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||2.32|-3.31|0.729
71926014|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.2||||0.196|TWO_SIDED|95.0|-5.64|1.16|||ANOVA|||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||1.16|-5.64|0.196
71926015|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|24.9||||0.03|TWO_SIDED|95.0|2.49|47.28|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||47.28|2.49|0.030
71926016|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-30.2||||0.018|TWO_SIDED|95.0|-55.24|-5.23|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||-5.23|-55.24|0.018
71926017|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.3||||0.611|TWO_SIDED|95.0|-25.98|15.29|||ANOVA|p-value \<=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||15.29|-25.98|0.611
71926018|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|13.8||||0.251|TWO_SIDED|95.0|-9.8|37.36|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||37.36|-9.80|0.251
71926019|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|4.4||||0.689|TWO_SIDED|95.0|-17.37|26.26|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||26.26|-17.37|0.689
71926020|NCT01945034|143372060|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.3||||0.486|TWO_SIDED|95.0|-35.69|17.01|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||17.01|-35.69|0.486
71926021|NCT01945034|143372061|SUPERIORITY_OR_OTHER||LS Mean Difference|38.5||||0.021|TWO_SIDED|95.0|5.9|71.18|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||71.18|5.90|0.021
71926022|NCT01945034|143372061|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.9||||0.603|TWO_SIDED|95.0|-38.02|22.12|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||22.12|-38.02|0.603
71926023|NCT01945034|143372061|SUPERIORITY_OR_OTHER||LS Mean Difference|-46.5||||0.013|TWO_SIDED|95.0|-82.93|-10.05|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||-10.05|-82.93|0.013
71926024|NCT01945034|143372062|SUPERIORITY_OR_OTHER||LS Mean Difference|87.7||||0.021|TWO_SIDED|95.0|13.48|161.85|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||161.85|13.48|0.021
71689459|NCT00435461|142895090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.4|-0.7|||ANCOVA|||Pre-dose iTNSS||-0.7|-1.4|<0.001
71689460|NCT00435461|142895090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.193|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Pre-dose iTNSS||0.1|-0.6|0.193
71689461|NCT00435461|142895090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.8|-0.2|||ANCOVA|||Pre-dose iTOSS||-0.2|-0.8|<0.001
71926025|NCT01945034|143372062|SUPERIORITY_OR_OTHER||LS Mean Difference|11.8||||0.735|TWO_SIDED|95.0|-56.59|80.11|||ANOVA|p-value \<=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||80.11|-56.59|0.735
71926026|NCT01945034|143372062|SUPERIORITY_OR_OTHER||LS Mean Difference|-75.9||||0.072|TWO_SIDED|95.0|-158.73|6.93|||ANOVA|||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.||6.93|-158.73|0.072
71926027|NCT01945034|143372062|SUPERIORITY_OR_OTHER||LS Mean Difference|46.0||||0.261|TWO_SIDED|95.0|-34.43|126.52|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||126.52|-34.43|0.261
71926028|NCT01945034|143372062|SUPERIORITY_OR_OTHER||LS Mean Difference|37.3||||0.325|TWO_SIDED|95.0|-37.13|111.8|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||111.80|-37.13|0.325
71926029|NCT01945034|143372062|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.7||||0.849|TWO_SIDED|95.0|-98.64|81.22|||ANOVA|p-value \<=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.||81.22|-98.64|0.849
71926030|NCT01945034|143372063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.042|TWO_SIDED|95.0|0.0|0.49|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.49|0.0|0.042
71926031|NCT01945034|143372063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.2||||0.114|TWO_SIDED|95.0|-0.04|0.4|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.40|-0.04|0.114
71926032|NCT01945034|143372063|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.598|TWO_SIDED|95.0|-0.34|0.2|||ANOVA|p-value \<=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.20|-0.34|0.598
71926033|NCT01945034|143372063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.833|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.19|-0.24|0.833
71926034|NCT01945034|143372063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.853|TWO_SIDED|95.0|-0.18|0.22|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI \< 0 for Ibuprofen treatment significantly better than combined Placebo.||0.22|-0.18|0.853
71926035|NCT01945034|143372063|SUPERIORITY_OR_OTHER||LS Mean Difference|0.0||||0.733|TWO_SIDED|95.0|-0.2|0.29|||ANOVA|p-value \<=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.||0.29|-0.20|0.733
71926036|NCT01945034|143372065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.45||||0.016|TWO_SIDED|95.0|1.07|1.97|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.||1.97|1.07|0.016
71926037|NCT01945034|143372065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.022|TWO_SIDED|95.0|0.53|0.95|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.95|0.53|0.022
71926038|NCT01945034|143372065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.49|||<|0.001|TWO_SIDED|95.0|0.34|0.69|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.69|0.34|< 0.001
71926039|NCT01945034|143372065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.79|||<|0.001|TWO_SIDED|95.0|1.27|2.51|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||2.51|1.27|< 0.001
71926040|NCT01945034|143372065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.009|TWO_SIDED|95.0|0.41|0.88|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.88|0.41|0.009
71926041|NCT01945034|143372065|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.34|||<|0.001|TWO_SIDED|95.0|0.22|0.52|||Proportional Hazards Model|p-value \<=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.||0.52|0.22|< 0.001
71926042|NCT01945034|143372067|SUPERIORITY_OR_OTHER|||||||0.479|||||||Cochran-Mantel-Haenszel|p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.||||||0.479
71926043|NCT01945034|143372067|SUPERIORITY_OR_OTHER|||||||0.279|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.279
71926044|NCT01945034|143372067|SUPERIORITY_OR_OTHER|||||||0.129|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.||||||0.129
71926045|NCT01798056|143372083|NON_INFERIORITY|Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.|Adjusted GMC ratio|23.2|||||TWO_SIDED|95.0|17.9|30.0||||Difference of means between vaccines and placebo were calculated together with 2-sided confidence intervals and back-transformed to the original units||The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).||30|17.9|
71926046|NCT02646566|143372147|SUPERIORITY|||||||0.003||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.003
71926047|NCT02646566|143372147|SUPERIORITY|||||||0.109||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.109
71926048|NCT02646566|143372148|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
71926049|NCT02646566|143372148|SUPERIORITY|||||||0.059||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.059
71926050|NCT02646566|143372149|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
71926051|NCT02646566|143372149|SUPERIORITY|||||||0.053||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.053
71926052|NCT02646566|143372150|SUPERIORITY||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||<0.001
71926053|NCT02646566|143372150|SUPERIORITY|||||||0.021||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.021
71926054|NCT02646566|143372151|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
71926055|NCT02646566|143372151|SUPERIORITY|||||||0.084|||||||Regression, Cox|||||||0.084
71926056|NCT02646566|143372152|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71689462|NCT00435461|142895090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.058|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.6|0.058
71926057|NCT02646566|143372152|SUPERIORITY|||||||0.004|||||||Chi-squared|||||||0.004
71926058|NCT02646566|143372153|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71926059|NCT02646566|143372153|SUPERIORITY|||||||0.179|||||||Chi-squared|||||||0.179
71926060|NCT02646566|143372154|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71926061|NCT02646566|143372154|SUPERIORITY|||||||0.315|||||||Chi-squared|||||||0.315
71926062|NCT02646566|143372155|SUPERIORITY|||||||0.065|||||||Chi-squared|||||||0.065
71926063|NCT02646566|143372155|SUPERIORITY|||||||0.52|||||||Chi-squared|||||||0.520
71926064|NCT02646566|143372156|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71926065|NCT02646566|143372156|SUPERIORITY|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.420
71926066|NCT02646566|143372157|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71926067|NCT02646566|143372157|SUPERIORITY|||||||0.258|||||||Wilcoxon (Mann-Whitney)|||||||0.258
71926068|NCT02222246|143372164|NON_INFERIORITY|Change in pain scores from arrival to discharge||||||0.0311|||||||Mixed Models Analysis|Analysis for pain change was conducted using Hierarchical Linear Mixed Effects Model (HLM), adjusting for nested patient and site effects (N=126)||||||0.0311
71926069|NCT02222246|143372165|NON_INFERIORITY|Trajectory of pain across time (arrival to discharge)||||||0.0049||||||p-value for the protocol by time interaction|Mixed Models Analysis|||The trajectory of change in pain score was evaluated every 30 minutes over 120 hours (2 hours) rather than 6 hours because of expected missing data after 120 minutes due to discharge from the ED.||||0.0049
71926070|NCT02222246|143372165|NON_INFERIORITY|Emergency Department Arrival||||||0.9393|||||||t-test, 2 sided|||||||0.9393
71926071|NCT02222246|143372165|NON_INFERIORITY|Post-placement 30 minutes||||||0.7259|||||||t-test, 2 sided|||||||0.7259
71926072|NCT02222246|143372165|NON_INFERIORITY|Post-placement 60 minutes||||||0.53|||||||t-test, 2 sided|||||||0.5300
71926073|NCT02222246|143372165|NON_INFERIORITY|Post-placement 90 minutes||||||0.3678|||||||t-test, 2 sided|||||||0.3678
71926074|NCT02222246|143372165|NON_INFERIORITY|Post-placement 120 minutes||||||0.2457|||||||t-test, 2 sided|||||||0.2457
71926075|NCT02222246|143372165|NON_INFERIORITY|Emergency Department Discharge||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71926076|NCT02222246|143372166|NON_INFERIORITY|Incidence of nausea during Emergency Department Visit - YES||||||0.0001|||||||Chi-squared|||||||0.0001
71926077|NCT02222246|143372167|NON_INFERIORITY|Incidence of vomiting (YES) during Emergency Department visit||||||0.6625|||||||Chi-squared|||||||0.6625
71926078|NCT02222246|143372168|NON_INFERIORITY|Decrease in systolic BP (\>= 20% of baseline)||||||0.4473|||||||Chi-squared|||||||0.4473
71926079|NCT02222246|143372169|NON_INFERIORITY|Decrease in diastolic blood pressure (\>= 20% baseline)||||||0.5372|||||||Chi-squared|||||||0.5372
71926080|NCT02222246|143372170|NON_INFERIORITY|Incidence of oxygen desaturation (\<95%) YES during Emergency Department visit||||||0.2891|||||||Chi-squared|||||||0.2891
71926081|NCT02222246|143372172|NON_INFERIORITY|Incidence of sedation during Emergency Department visit.||||||0.3915|||||||Chi-squared|||||||0.3915
71926082|NCT02222246|143372173|NON_INFERIORITY|Incidence of the need for supplemental oxygen during Emergency Department visit||||||0.0726|||||||Chi-squared|||||||0.0726
71926083|NCT02660489|143372176|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71926084|NCT02660489|143372177|SUPERIORITY|||||||0.49|||||||t-test, 2 sided|||||||0.49
71926085|NCT02660489|143372178|SUPERIORITY|||||||0.5|||||||t-test, 2 sided|||||||0.50
71926086|NCT02660489|143372179|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71926087|NCT02660489|143372180|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71926088|NCT02660489|143372181|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71926089|NCT02660489|143372182|SUPERIORITY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||||||0.75
71926090|NCT02660489|143372183|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||||||0.66
71926091|NCT04621227|143372200|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|202.94|||||TWO_SIDED|90.0|167.14|246.41|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \[Period 4\] vs Rosuvastatin 10mg \[Period 1\])||246.41|167.14|
71926092|NCT04621227|143372200|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|283.73|||||TWO_SIDED|90.0|233.68|344.51|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \[Period 7\] vs Rosuvastatin 10mg \[Period 1\])||344.51|233.68|
71926093|NCT04621227|143372201|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.57|||||TWO_SIDED|90.0|42.27|60.5|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \[Period 5\] vs Midazolam 2mg \[Period 2\])||60.50|42.27|
71689463|NCT00435461|142895090|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.15||0.16|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|||Pre-dose iTOSS||0|-0.5|0.16
71689464|NCT00435461|142895091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.7|11.9|||ANCOVA|||Morning assessment||11.9|5.7|<0.001
71689465|NCT00435461|142895091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|STANDARD_ERROR_OF_MEAN|1.59|<|0.001|TWO_SIDED|95.0|5.3|11.5|||ANCOVA|||Morning assessment||11.5|5.3|<0.001
71926094|NCT04621227|143372201|OTHER|The ratio and 90% confidence interval were expressed as percentages.|Adjusted Geometric Mean Ratio (%)|50.56|||||TWO_SIDED|90.0|42.06|60.78|||Mixed Models Analysis|||Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \[Period 8\] vs Midazolam 2mg \[Period 2\])||60.78|42.06|
71926095|NCT01342445|143372218|SUPERIORITY_OR_OTHER_LEGACY||Partial eta squared|0.34|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 10.9~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<0.001
71926096|NCT01342445|143372219|SUPERIORITY_OR_OTHER_LEGACY||partial eta squared|0.28|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 8.14~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.||||<.001
71926097|NCT05299359|143372220|NON_INFERIORITY|If the lower limit of the 95% CI is \>= 0.67, then the immune response to a single heterologous booster vaccination of TAK-019 is considered to be non-inferior of that to the primary series of TAK-019.|LS Mean Difference|1.18|||||TWO_SIDED|95.0|0.95|1.47||||||GMT ratio was calculated GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36.||1.47|0.95|
71926098|NCT02652793|143372268|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in lumbar spine BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.01|STANDARD_DEVIATION|0.03||0.0239|TWO_SIDED|95.0|0.001|0.019||Statistical test applied to lumbar spine BMD only. P-value reflects within-group change from baseline to Week 48.|Regression, Linear|Per-protocol analysis; missing data excluded|Represents mean change in lumbar spine BMD from baseline to Week 48.|Single-arm study; no comparator group||0.019|0.001|0.0239
71926099|NCT02652793|143372268|SUPERIORITY|Single-arm pilot study to assess BMD improvement after switching therapy. Null hypothesis: no change in left hip BMD at Week 48. Sample size of 45 planned to detect a 2% increase with 90% power (α=0.025). Final analysis included 30 participants.|Mean Difference (Final Values)|0.013|STANDARD_DEVIATION|0.03||0.0046|TWO_SIDED|95.0|0.004|0.023||Left hip|Regression, Linear|Statistical test applied to left hip BMD only. P-value reflects within-group change from baseline to Week 48.|Represents mean change in left hip BMD from baseline to Week 48|Single-arm study; no comparator group||0.023|0.004|0.0046
71926100|NCT04579666|143372305|SUPERIORITY||Difference in LS Mean|-3.0||||0.7205|TWO_SIDED|95.0|-19.5|13.5|||ANCOVA|||Analysis of covariance (ANCOVA) was used to analyze the ranks of the CAFS score with treatment as a fixed effect, adjusted for baseline ALSFRS-R total score, time from symptom onset, baseline Log neurofilament light chain (NfL), and the randomization stratification factors (location of first muscle weakness and use of riluzole and edaravone).||13.5|-19.5|0.7205
71926101|NCT04579666|143372310|SUPERIORITY||Difference in LS Mean|-0.7||||0.6447|TWO_SIDED|95.0|-3.5|2.2|||MMRM|||The mixed-effect model for repeated measures (MMRM) included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors location of first muscle weakness and use of riluzole and/or edaravone).||2.2|-3.5|0.6447
71926102|NCT04579666|143372311|SUPERIORITY||Difference in LS Mean|-6.6||||0.0949|TWO_SIDED|95.0|-14.3|1.2|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||1.2|-14.3|0.0949
71926103|NCT04579666|143372312|SUPERIORITY||Difference in LS Mean|-0.19||||0.0935|TWO_SIDED|95.0|-0.42|0.03|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||0.03|-0.42|0.0935
71926104|NCT04579666|143372314|SUPERIORITY||Difference in LS Mean|6.5||||0.0069|TWO_SIDED|95.0|1.8|11.1|||MMRM|||The MMRM included fixed categorical effects for treatment, week, and the week-by-treatment interaction, as well as the continuous, fixed covariate of the baseline value of the endpoint, and the week-by-baseline interaction, baseline log NfL, time from symptoms onset to the first dose of study drug, and randomization stratification factors (location of first muscle weakness and use of riluzole and/or edaravone).||11.1|1.8|0.0069
71926105|NCT01151085|143372344|SUPERIORITY_OR_OTHER||||||=|0.03|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the Frequency of Treatment Related Adverse Events."||||=0.030
71926106|NCT01151085|143372345|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||"The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events."||||<0.001
71926107|NCT01151085|143372346|SUPERIORITY_OR_OTHER||||||=|0.017|TWO_SIDED||||||Fisher Exact|||"The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events."||||=0.017
71926108|NCT01151085|143372347|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Chi-squared|||Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.||||<0.001
71926109|NCT03413618|143372385|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71926110|NCT03413618|143372386|SUPERIORITY|||||||0.049|||||||Log Rank|||||||0.049
71926111|NCT03413618|143372388|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71926112|NCT03413618|143372389|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71926113|NCT03413618|143372391|SUPERIORITY|||||||0.001|||||||Fisher Exact|||||||0.001
71926114|NCT03413618|143372392|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71926115|NCT04753606|143372417|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
71926116|NCT04753606|143372417|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
71926117|NCT04753606|143372418|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
71926118|NCT04753606|143372418|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
71926119|NCT04753606|143372419|SUPERIORITY||Least Squares (LS) Means|-32.96|STANDARD_ERROR_OF_MEAN|4.943|<|0.0001|TWO_SIDED|95.0|-44.03|-21.9|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.90|-44.03|<.0001
71926120|NCT04753606|143372419|SUPERIORITY||Least Squares (LS) Means|-39.18|STANDARD_ERROR_OF_MEAN|4.927|<|0.0001|TWO_SIDED|95.0|-50.21|-28.15|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-28.15|-50.21|<.0001
71926121|NCT04753606|143372420|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
71926122|NCT04753606|143372420|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
71926123|NCT04753606|143372421|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
71926124|NCT04753606|143372421|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
71926125|NCT04753606|143372422|SUPERIORITY||Least Squares (LS) Means|-28.94|STANDARD_ERROR_OF_MEAN|4.643|<|0.0001|TWO_SIDED|95.0|-38.14|-19.74|||ANCOVA|||||-19.74|-38.14|<.0001
71926126|NCT04753606|143372422|SUPERIORITY||Least Squares (LS) Means|-40.07|STANDARD_ERROR_OF_MEAN|4.591|<|0.0001|TWO_SIDED|95.0|-49.16|-30.97|||ANCOVA|||||-30.97|-49.16|<.0001
71926127|NCT04753606|143372423|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
71926128|NCT04753606|143372423|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
71926129|NCT04753606|143372424|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
71926130|NCT04753606|143372424|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
71926131|NCT04753606|143372425|SUPERIORITY||Least Squares (LS) Means|-18.26|STANDARD_ERROR_OF_MEAN|3.657|<|0.0001|TWO_SIDED|95.0|-25.51|-11.02|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-11.02|-25.51|<.0001
71926132|NCT04753606|143372425|SUPERIORITY||Least Squares (LS) Means|-23.99|STANDARD_ERROR_OF_MEAN|3.65|<|0.0001|TWO_SIDED|95.0|-31.22|-16.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-16.76|-31.22|<.0001
71926133|NCT04753606|143372426|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
71926134|NCT04753606|143372426|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
71926135|NCT04753606|143372427|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
71926136|NCT04753606|143372427|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
71926137|NCT04753606|143372428|SUPERIORITY||Least Squares (LS) Means|-30.54|STANDARD_ERROR_OF_MEAN|4.503|<|0.0001|TWO_SIDED|95.0|-39.46|-21.62|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-21.62|-39.46|<.0001
71926138|NCT04753606|143372428|SUPERIORITY||Least Squares (LS) Means|-36.03|STANDARD_ERROR_OF_MEAN|4.488|<|0.0001|TWO_SIDED|95.0|-44.92|-27.14|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||-27.14|-44.92|<.0001
71926139|NCT04753606|143372429|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
71926140|NCT04753606|143372429|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
71926141|NCT04753606|143372430|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
71926142|NCT04753606|143372430|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
71926143|NCT04753606|143372431|SUPERIORITY||Least Squares (LS) Means|129.27|STANDARD_ERROR_OF_MEAN|9.337|<|0.0001|TWO_SIDED|95.0|110.78|147.77|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||147.77|110.78|<.0001
71926144|NCT04753606|143372431|SUPERIORITY||Least Squares (LS) Means|164.33|STANDARD_ERROR_OF_MEAN|9.306|<|0.0001|TWO_SIDED|95.0|145.9|182.76|||Mixed Models Analysis|mixed model for repeated measures (MMRM) with missing at random assumption||||182.76|145.90|<.0001
71926145|NCT03841331|143372432|SUPERIORITY||Treatment Effect|-1.4||||0.5861|TWO_SIDED|95.0|-13.9|11.1|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used|At Week 10||11.1|-13.9|0.5861
71926146|NCT03841331|143372433|SUPERIORITY||Treatment Effect|-0.7||||0.5651|TWO_SIDED|95.0|-10.1|8.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||8.7|-10.1|0.5651
71926147|NCT03841331|143372433|SUPERIORITY||Treatment Effect|-4.1||||0.7769|TWO_SIDED|95.0|-14.8|6.7|||Cochran-Mantel-Haenszel|||At Week 4|95% Wald confidence intervals for the treatment difference was used.|6.7|-14.8|0.7769
71926148|NCT03841331|143372433|SUPERIORITY||Treatment Effect|2.8||||0.3285|TWO_SIDED|95.0|-9.1|14.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||14.8|-9.1|0.3285
71926149|NCT03841331|143372433|SUPERIORITY||Treatment Effect|-2.3||||0.6525|TWO_SIDED|95.0|-14.4|9.8|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.8|-14.4|0.6525
71926150|NCT03841331|143372434|SUPERIORITY||Treatment effect|0.0||||0.4952|TWO_SIDED|95.0|-5.6|5.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 2||5.7|-5.6|0.4952
71926151|NCT03841331|143372434|SUPERIORITY||Treatment effect|5.2||||0.0891|TWO_SIDED|95.0|-2.3|12.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 4||12.7|-2.3|0.0891
71926152|NCT03841331|143372434|SUPERIORITY||Treatment effect|-4.2||||0.8447|TWO_SIDED|95.0|-12.1|3.7|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 6||3.7|-12.1|0.8447
71926153|NCT03841331|143372434|SUPERIORITY||Treatment effect|1.0||||0.4174|TWO_SIDED|95.0|-7.5|9.4|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 8||9.4|-7.5|0.4174
71926154|NCT03841331|143372434|SUPERIORITY||Treatment effect|2.7||||0.2756|TWO_SIDED|95.0|-5.8|11.2|||Cochran-Mantel-Haenszel||95% Wald confidence intervals for the treatment difference was used.|At Week 10||11.2|-5.8|0.2756
71926155|NCT03841331|143372435|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.4409|TWO_SIDED|95.0|-0.49|0.57|||ANOVA|||At Week 2||0.57|-0.49|0.4409
71926156|NCT03841331|143372435|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.5496|TWO_SIDED|95.0|-0.65|0.57||At week 4|ANOVA|||At Week 4||0.57|-0.65|0.5496
71926157|NCT03841331|143372435|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.6311|TWO_SIDED|95.0|-0.78|0.55|||ANOVA|||At Week 6||0.55|-0.78|0.6311
71926158|NCT03841331|143372435|SUPERIORITY||Mean Difference (Final Values)|0.4738||||0.02|TWO_SIDED|95.0|-0.65|0.69|||ANOVA|||At Week 8||0.69|-0.65|0.02
71926159|NCT03841331|143372435|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.3948|TWO_SIDED|95.0|-0.6|0.78|||ANOVA|||At Week 10||0.78|-0.60|0.3948
71926160|NCT03841331|143372437|SUPERIORITY||Mean Difference (Final Values)|2.44||||0.244|TWO_SIDED|95.0|-4.98|9.87|||ANOVA|||At Week 2||9.87|-4.98|0.2440
71926161|NCT03841331|143372437|SUPERIORITY||Mean Difference (Final Values)|-1.27||||0.6349|TWO_SIDED|95.0|-9.2|6.65|||ANOVA|||At Week 4||6.65|-9.20|0.6349
71926162|NCT03841331|143372437|SUPERIORITY||Mean Difference (Final Values)|0.3407||||1.91|TWO_SIDED|95.0|-6.4|10.23|||ANOVA|||At Week 6||10.23|-6.40|1.91
71926163|NCT03841331|143372437|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.496|TWO_SIDED|95.0|-8.52|8.97|||ANOVA|||At Week 10||8.97|-8.52|0.4960
71926164|NCT02743117|143372440|SUPERIORITY_OR_OTHER||Rate Difference|-1.3|||||TWO_SIDED|95.0|-8.1|1.3||||||||1.3|-8.1|
71926165|NCT02743117|143372441|SUPERIORITY_OR_OTHER||Rate Difference|-8.2|||||TWO_SIDED|95.0|-22.2|4.6||||||Up to Day 8||4.6|-22.2|
71926166|NCT02743117|143372441|SUPERIORITY_OR_OTHER||Rate Difference|-7.4|||||TWO_SIDED|95.0|-21.6|5.9||||||Up to Day 15||5.9|-21.6|
71926167|NCT00766727|143372445|SUPERIORITY||Mean Difference (Final Values)|-31.88|STANDARD_DEVIATION|14.25|||TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||
71926168|NCT03948646|143372451|OTHER||Odds Ratio (OR)|2.0||||0.0029|TWO_SIDED|95.0|1.27|3.15|||Regression, Logistic|||||3.15|1.27|0.0029
71926169|NCT03948646|143372452|OTHER||Mean Difference (Net)|-21.77|STANDARD_ERROR_OF_MEAN|9.994||0.0296|TWO_SIDED|95.0|-41.37|-2.16|||ANCOVA|||||-2.16|-41.37|0.0296
71926170|NCT00634933|143372463|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.||||0.061
71926171|NCT00634933|143372463|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.120
71926172|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.570
71926173|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.200
71926174|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.616|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.616
71926175|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.671
71926176|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.108
71926177|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.174|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.174
71926178|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.010
71926179|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.029|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.029
71926180|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
71926181|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.021
71926182|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.062|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.062
71926183|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.049|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.049
71926184|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.030
71926185|NCT00634933|143372464|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.005
71926186|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.014
71926187|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.025
71926188|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.794|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.794
71926189|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.966|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.966
71926190|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.770
71926191|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.456|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.456
71926192|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.880
71926193|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.814|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.814
71926194|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.042|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.042
71926195|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.035
71926196|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.086
71926197|NCT00634933|143372465|SUPERIORITY_OR_OTHER|||||||0.082|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.082
71926198|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.325
71926199|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.338|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.338
71926200|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.983|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.983
71926201|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.296
71926202|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.575|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.575
71926203|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||1.000
71926204|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.573
71926205|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.563|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.563
71926206|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.768|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.768
71926207|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.977|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.977
71926208|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.249|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.249
71926209|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.268|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.268
71926210|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.089|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.089
71926211|NCT00634933|143372466|SUPERIORITY_OR_OTHER|||||||0.079|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.079
71926212|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.106|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.106
71926213|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.322|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.322
71926214|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.059|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.059
71926215|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.250
71926216|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.255|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.255
71926217|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.105|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.105
71926218|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.001
71926219|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.019|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.019
71926220|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.011
71926221|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.113|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.113
71926222|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.002
71926223|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.006
71926224|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.034|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.034
71926225|NCT00634933|143372481|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.||||0.003
71926226|NCT01049360|143372482|SUPERIORITY_OR_OTHER||Least square mean difference|0.2|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.156|0.245||Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|Mixed Models Analysis|||||0.245|0.156|<0.0001
71926227|NCT01049360|143372482|SUPERIORITY_OR_OTHER||Least square mean difference|0.202|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.158|0.245|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.245|0.158|<0.0001
71926228|NCT01049360|143372483|SUPERIORITY_OR_OTHER||Least square mean difference|0.132|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.083|0.181|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.181|0.083|<0.0001
71926229|NCT01049360|143372483|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|STANDARD_ERROR_OF_MEAN|0.025|<|0.0001|TWO_SIDED|95.0|0.088|0.185|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.185|0.088|<0.0001
71926230|NCT01049360|143372484|SUPERIORITY_OR_OTHER||Least squares mean difference|0.281|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.23|0.333|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.333|0.230|<0.0001
71926231|NCT01049360|143372484|SUPERIORITY_OR_OTHER||Least squares mean difference|0.275|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001|TWO_SIDED|95.0|0.224|0.325|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate||||0.325|0.224|<0.0001
71926232|NCT01694849|143372485|SUPERIORITY||Odds Ratio (OR)|1.092||||0.8539|TWO_SIDED|95.0|0.427|2.795||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.795|0.427|0.8539
71689466|NCT00435461|142895091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.59||0.779|TWO_SIDED|95.0|-3.6|2.7|||ANCOVA|||Morning assessment||2.7|-3.6|0.779
71689467|NCT00435461|142895091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.1|9.6|||ANCOVA|||Evening assessment||9.6|3.1|<0.001
71689468|NCT00435461|142895091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|3.8|10.3|||ANCOVA|||Evening assessment||10.3|3.8|<0.001
71689469|NCT00435461|142895091|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|1.65||0.662|TWO_SIDED|95.0|-2.5|4.0|||ANCOVA|||Evening assessment||4|-2.5|0.662
71926233|NCT01694849|143372485|SUPERIORITY||Odds Ratio (OR)|0.897||||0.816|TWO_SIDED|95.0|0.361|2.232||To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined.|Regression, Logistic|Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values|Standard error of the estimate|H\_01: OR\_80 less than or equal to 1 versus H\_11 : OR\_80 greater than 1 H\_02: OR\_120 less than or equal to 1 versus H\_12 : OR\_120 greater than 1||2.232|0.361|0.8160
71926234|NCT01694849|143372486|SUPERIORITY||difference in least square mean change|-0.27||||0.225|TWO_SIDED|95.0|-0.75|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.75|0.225
71926235|NCT01694849|143372486|SUPERIORITY||Difference in least square mean change|-0.28||||0.254|TWO_SIDED|95.0|-0.76|0.2|||Mixed Models Analysis|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the least squares mean|"H0: difference in least squares (LS) mean change from baseline equal to 0 H1: difference in LS mean change from baseline not equal to 0~Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4"||0.2|-0.76|0.254
71926236|NCT01694849|143372487|SUPERIORITY||Odds Ratio (OR)|1.073||||0.8586|TWO_SIDED|95.0|0.493|2.339|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score.|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.339|0.493|0.8586
71689470|NCT00435461|142895092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA|||||-0.3|-0.7|<0.001
71689471|NCT00435461|142895092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.203|TWO_SIDED|95.0|-0.4|0.1|||ANCOVA|||||0.1|-0.4|0.203
71689472|NCT00435461|142895092|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-0.8|-0.4|||ANCOVA|||||-0.4|-0.8|<0.001
71689473|NCT02488018|142895107|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|99.0|||||ANOVA|Degree of freedom for the model (treatment) was 8.||Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.||||<0.01
71689474|NCT01850394|142895108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|180.0|STANDARD_DEVIATION|300.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71689475|NCT01850394|142895108|SUPERIORITY_OR_OTHER||Mean Difference (Net)|150.0|STANDARD_DEVIATION|200.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71689476|NCT01850394|142895109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|140.0|STANDARD_DEVIATION|15.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71689477|NCT01850394|142895109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.0|STANDARD_DEVIATION|4.0|<|0.05|TWO_SIDED|95.0|||||ANOVA|||||||<0.05
71689478|NCT01850394|142895110|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.25|STANDARD_ERROR_OF_MEAN|0.1|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71689479|NCT01850394|142895111|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|STANDARD_ERROR_OF_MEAN|0.02|<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||||||<0.05
71689480|NCT01850394|142895112|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.66|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0|||||ANOVA|||||||0.05
71926237|NCT01694849|143372487|SUPERIORITY||Odds Ratio (OR)|1.601||||0.2265|TWO_SIDED|95.0|0.747|3.432|||Regression, Logistic|Baseline Non-Alcoholic Fatty Liver Disease Activity Score|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.432|0.747|0.2265
71926238|NCT01694849|143372488|SUPERIORITY||Odds Ratio (OR)|0.723||||0.5231|TWO_SIDED|95.0|0.267|1.958|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.958|0.267|0.5231
71689481|NCT05446142|142895129|OTHER||Reference/Test Ratio|95.25|||||TWO_SIDED|90.0|90.82|99.9||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.90|90.82|
71926239|NCT01694849|143372488|SUPERIORITY||Odds Ratio (OR)|1.102||||0.8459|TWO_SIDED|95.0|0.415|2.924|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.924|0.415|0.8459
71926240|NCT01694849|143372489|SUPERIORITY||Odds Ratio (OR)|0.638||||0.5229|TWO_SIDED|95.0|0.161|2.529|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.529|0.161|0.5229
71926241|NCT01694849|143372489|SUPERIORITY||Odds Ratio (OR)|1.433||||0.5646|TWO_SIDED|95.0|0.421|4.875|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||4.875|.421|0.5646
71926242|NCT01694849|143372490|SUPERIORITY||Odds Ratio (OR)|0.382||||0.1983|TWO_SIDED|95.0|0.088|1.656|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.656|0.088|0.1983
71926243|NCT01694849|143372490|SUPERIORITY||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.288|3.466|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||3.466|0.288|1.0000
71926244|NCT01694849|143372491|SUPERIORITY||Odds Ratio (OR)|0.653||||0.3543|TWO_SIDED|95.0|0.265|1.609|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||1.609|0.265|0.3543
71926245|NCT01694849|143372491|SUPERIORITY||Odds Ratio (OR)|1.27||||0.578|TWO_SIDED|95.0|0.547|2.953|||Regression, Logistic|Baseline value of the analyzed parameter|Standard error of the estimate|Population with baseline Non-Alcoholic Fatty Liver Disease Activity Score greater than or equal to 4||2.953|0.547|0.5780
71926246|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|1.24||||0.711|TWO_SIDED|95.0|-5.33|7.81|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||7.81|-5.33|0.711
71926247|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-0.94||||0.78|TWO_SIDED|95.0|-7.58|5.7|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in aspartate transaminase (U/L)||5.7|-7.58|0.78
71926248|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-6.13||||0.221|TWO_SIDED|95.0|-15.97|3.71|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||3.71|-15.97|0.221
71689482|NCT05446142|142895129|OTHER||Reference/Test Ratio|96.3|||||TWO_SIDED|90.0|91.71|101.12||||||Natural log transformed encorafenib AUCinf was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||101.12|91.71|
71926249|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-9.45||||0.062|TWO_SIDED|95.0|-19.4|0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in alanine aminotransferase (U/L)||0.49|-19.4|0.062
71926250|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-23.02|||<|0.001|TWO_SIDED|95.0|-27.16|-18.88|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||-18.88|-27.16|<0.001
71926251|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-23.85|||<|0.001|TWO_SIDED|95.0|-28.04|2.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Alkaline phosphatases (U/L)||2.12|-28.04|<0.001
71926252|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-31.41|||<|0.001|TWO_SIDED|95.0|-43.78|-19.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-19.05|-43.78|<0.001
71926253|NCT01694849|143372492|SUPERIORITY||Difference in least square mean change|-29.31|||<|0.001|TWO_SIDED|95.0|-41.84|-16.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Change in Gamma-glutamyl transferase (U/L)||-16.77|-41.84|<0.001
71926254|NCT01694849|143372493|SUPERIORITY||Difference in least square mean change|0.14|||<|0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.21|0.06|<0.001
71926255|NCT01694849|143372493|SUPERIORITY||Difference in least square mean change|0.19|||<|0.001|TWO_SIDED|95.0|0.11|0.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.26|0.11|<0.001
71926256|NCT01694849|143372494|SUPERIORITY||Difference in least square mean change|141.78||||0.095|TWO_SIDED|95.0|-24.99|308.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||308.55|-24.99|0.095
71926257|NCT01694849|143372494|SUPERIORITY||Difference in least square mean change|-70.57||||0.412|TWO_SIDED|95.0|-239.85|98.71||Baseline parameter value and presence of diabetes as random factors|Mixed Models Analysis||Standard error of the least square mean|||98.71|-239.85|0.412
71926258|NCT01694849|143372495|SUPERIORITY||Difference in least square mean change|32.39||||0.592|TWO_SIDED|95.0|-86.63|151.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||151.42|-86.63|0.592
71926259|NCT01694849|143372495|SUPERIORITY||Difference in least square mean change|31.35||||0.61|TWO_SIDED|95.0|-89.42|152.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||152.12|-89.42|0.61
71926260|NCT01694849|143372496|SUPERIORITY||Difference in least square mean change|1.67||||0.459|TWO_SIDED|95.0|-2.77|6.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.11|-2.77|0.459
71926261|NCT01694849|143372496|SUPERIORITY||Difference in least square mean change|-0.67||||0.764|TWO_SIDED|95.0|-5.06|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|-5.06|0.764
71926262|NCT01694849|143372497|SUPERIORITY||Difference in least square mean change|-12.92||||0.466|TWO_SIDED|95.0|-47.79|21.95|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||21.95|-47.79|0.466
71926263|NCT01694849|143372497|SUPERIORITY||Difference in least square mean change|-5.82||||0.745|TWO_SIDED|95.0|-41.07|29.42|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||29.42|-41.07|0.745
71926264|NCT01694849|143372498|SUPERIORITY||Difference in least square mean change|-26.57||||0.018|TWO_SIDED|95.0|-48.59|-4.54|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-4.54|-48.59|0.018
71926265|NCT01694849|143372498|SUPERIORITY||Difference in least square mean change|-40.39|||<|0.001|TWO_SIDED|95.0|-62.61|-18.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG19||-18.17|-62.61|<0.001
71926266|NCT01694849|143372498|SUPERIORITY||Difference in least square mean change|190.07||||0.101|TWO_SIDED|95.0|-37.38|417.52|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||417.52|-37.38|0.101
71926267|NCT01694849|143372498|SUPERIORITY||Difference in least square mean change|228.33||||0.052|TWO_SIDED|95.0|-2.16|458.82|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|FG21||458.82|-2.16|0.052
71926268|NCT01694849|143372499|SUPERIORITY||Difference in least square mean change|-0.14||||0.002|TWO_SIDED|95.0|-0.29|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.29|0.002
71926269|NCT01694849|143372499|SUPERIORITY||Difference in least square mean change|-0.24|||<|0.001|TWO_SIDED|95.0|-0.34|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.15|-0.34|<0.001
71926270|NCT01694849|143372500|SUPERIORITY||Difference in least square mean change|-16.54||||0.203|TWO_SIDED|95.0|-42.07|8.98|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Hyaluronic acid||8.98|-42.07|0.203
71926271|NCT01694849|143372500|SUPERIORITY||Difference in least square mean change|-6.79||||0.603|TWO_SIDED|95.0|-32.49|18.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||18.9|-32.49|0.603
71926272|NCT01694849|143372500|SUPERIORITY||Difference in least square mean change|-0.73||||0.235|TWO_SIDED|95.0|-1.95|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.48|-1.95|0.235
71926273|NCT01694849|143372500|SUPERIORITY||Difference in least square mean change|-0.81||||0.193|TWO_SIDED|95.0|-2.04|0.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|PIIINP||0.41|-2.04|0.193
71926274|NCT01694849|143372500|SUPERIORITY||Difference in least square mean change|6.21||||0.348|TWO_SIDED|95.0|-6.81|19.22|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||19.22|-6.81|0.348
71926275|NCT01694849|143372500|SUPERIORITY||Difference in least square mean change|-14.66||||0.029|TWO_SIDED|95.0|-27.81|1.51|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|TIMP-1||1.51|-27.81|0.029
71926276|NCT01694849|143372501|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.07|<0.001
71926277|NCT01694849|143372501|SUPERIORITY||Difference in least square mean change|-0.05|||<|0.001|TWO_SIDED|95.0|-0.08|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.02|-0.08|<0.001
71926278|NCT01694849|143372502|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
71926279|NCT01694849|143372502|SUPERIORITY||Difference in least square mean change|-0.11|||<|0.001|TWO_SIDED|95.0|-0.15|-0.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.07|-0.15|<0.001
71926280|NCT01694849|143372503|SUPERIORITY||Difference in least square mean change|0.06||||0.471|TWO_SIDED|95.0|-0.11|0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.23|-0.11|0.471
71926281|NCT01694849|143372503|SUPERIORITY||Difference in least square mean change|-0.25||||0.005|TWO_SIDED|95.0|-0.42|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.42|0.005
71926282|NCT01694849|143372504|SUPERIORITY||Difference in least square mean change|-0.07||||0.457|TWO_SIDED|95.0|-0.27|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.27|0.457
71926283|NCT01694849|143372504|SUPERIORITY||Difference in least square mean|-0.08||||0.428|TWO_SIDED|95.0|-0.28|0.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.12|-0.28|0.428
71926284|NCT01694849|143372505|SUPERIORITY||Difference in least square mean change|-9.22|||<|0.001|TWO_SIDED|95.0|-13.19|-5.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.24|-13.19|<0.001
71926285|NCT01694849|143372505|SUPERIORITY||Difference in least square mean change|-9.08|||<|0.001|TWO_SIDED|95.0|-13.12|-5.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-5.04|-13.12|<0.001
71926286|NCT01694849|143372506|SUPERIORITY||Difference in least square mean change|0.02||||0.531|TWO_SIDED|95.0|-0.05|0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.09|-0.05|0.531
71926287|NCT01694849|143372506|SUPERIORITY||Difference in least square mean change|-0.02||||0.638|TWO_SIDED|95.0|-0.08|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.08|0.638
71926288|NCT01694849|143372507|SUPERIORITY||Difference in least square mean change|-0.14||||0.831|TWO_SIDED|95.0|-1.39|1.12|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.12|-1.39|0.831
71926289|NCT01694849|143372507|SUPERIORITY||Difference in least square mean change|0.2||||0.754|TWO_SIDED|95.0|-1.07|1.47|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Total bilirubin||1.47|-1.07|0.754
71926290|NCT01694849|143372507|SUPERIORITY||Difference in least square mean change|-0.03||||0.848|TWO_SIDED|95.0|-0.36|0.3|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.3|-0.36|0.848
71926291|NCT01694849|143372507|SUPERIORITY||Difference in least square mean change|0.11||||0.511|TWO_SIDED|95.0|-0.22|0.45|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Conjugated Bilirubin||0.45|-0.22|0.511
71926292|NCT01694849|143372508|SUPERIORITY||Difference in least square mean change|-2.83||||0.075|TWO_SIDED|95.0|-5.95|0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.29|-5.95|0.075
71926293|NCT01694849|143372508|SUPERIORITY||Difference in least square mean change|-1.11||||0.491|TWO_SIDED|95.0|-4.29|2.07|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.07|-4.29|0.491
71926294|NCT01694849|143372509|SUPERIORITY||Difference in least square mean change|-0.03||||0.393|TWO_SIDED|95.0|-0.1|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.1|0.393
71926295|NCT01694849|143372509|SUPERIORITY||Difference in least square mean change|-0.04||||0.289|TWO_SIDED|95.0|-0.11|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.11|0.289
71689483|NCT05446142|142895129|OTHER||Reference/Test Ratio|96.57|||||TWO_SIDED|90.0|82.91|112.47||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||112.47|82.91|
71689484|NCT05446142|142895129|OTHER||Reference/Test Ratio|88.56|||||TWO_SIDED|90.0|82.59|94.95||||||Natural log transformed encorafenib AUCinf was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.95|82.59|
71689485|NCT05446142|142895130|OTHER||Reference/Test Ratio|104.31|||||TWO_SIDED|90.0|91.4|119.04||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||119.04|91.40|
71689486|NCT05446142|142895130|OTHER||Reference/Test Ratio|90.35|||||TWO_SIDED|90.0|79.17|103.12||||||Natural log transformed encorafenib Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||103.12|79.17|
71926296|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.47|||<|0.001|TWO_SIDED|95.0|-0.73|-0.21|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.21|-0.73|<0.001
71926297|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.55|||<|0.001|TWO_SIDED|95.0|-0.81|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Triglycerides||-0.29|-0.81|<0.001
71926298|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.35||||0.001|TWO_SIDED|95.0|-0.56|-0.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.14|-0.56|0.001
71926299|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.43|||<|0.001|TWO_SIDED|95.0|-0.64|-0.23|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Cholesterol||-0.23|-0.64|<0.001
71689487|NCT05446142|142895130|OTHER||Reference/Test Ratio|79.66|||||TWO_SIDED|90.0|58.7|108.08||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||108.08|58.70|
71689488|NCT05446142|142895130|OTHER||Reference/Test Ratio|80.78|||||TWO_SIDED|90.0|64.82|100.68||||||Natural log transformed encorafenib Cmax was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.68|64.82|
71689489|NCT05446142|142895131|OTHER||Reference/Test Ratio|95.34|||||TWO_SIDED|90.0|90.37|100.59||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||100.59|90.37|
71689490|NCT05446142|142895131|OTHER||Reference/Test Ratio|94.67|||||TWO_SIDED|90.0|89.73|99.88||||||Natural log transformed encorafenib AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to CAP) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to CAP) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||99.88|89.73|
71689491|NCT05446142|142895131|OTHER||Reference/Test Ratio|95.76|||||TWO_SIDED|90.0|84.1|109.04||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCC relative to eMCC with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCC relative to eMCC with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||109.04|84.10|
71689492|NCT05446142|142895131|OTHER||Reference/Test Ratio|88.31|||||TWO_SIDED|90.0|82.36|94.7||||||Natural log transformed encorafenib AUClast was analyzed using ANOVA with treatment and sequence as a fixed effect and participant within sequence as a random effect. The adjusted mean differences (eMCCL relative to eMCCL with rabeprazole) and corresponding 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (eMCCL relative to eMCCL with rabeprazole) and 90% CIs for the ratios. The geometric mean ratios are presented as percentages.||94.70|82.36|
71689493|NCT02098395|142895140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.5|-0.2|||Mixed Models Analysis|||Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.||-0.2|-0.5|< 0.0001
71689494|NCT02098395|142895140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23|||=|0.0021|TWO_SIDED|95.0|-0.38|-0.08|||Mixed Models Analysis|||Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.||-0.08|-0.38|= 0.0021
71689495|NCT02098395|142895140|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|||=|0.0011|TWO_SIDED|95.0|-0.39|-0.1|||Mixed Models Analysis|||Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.||-0.1|-0.39|= 0.0011
71689496|NCT00547157|142895145|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.09|||||TWO_SIDED|95.0|-0.26|0.07|||||difference is PRT - CRT|||0.07|-0.26|
71689497|NCT00547157|142895146|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.613||||0.0601|TWO_SIDED|95.0|0.98|2.656|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.656|0.980|0.0601
71689498|NCT00547157|142895147|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.731||||0.0259|TWO_SIDED|95.0|1.068|2.806|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.|||2.806|1.068|0.0259
71689499|NCT00547157|142895148|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593||||0.1039|TWO_SIDED|95.0|0.909|2.793|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy|||2.793|0.909|0.1039
71689500|NCT00547157|142895149|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.791||||0.5744|TWO_SIDED|95.0|0.342|1.785|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||1.785|0.342|0.5744
71689501|NCT00547157|142895149|SUPERIORITY_OR_OTHER||Difference in objective response rate|-0.044|||||TWO_SIDED|95.0|-0.187|0.112|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.112|-0.187|
71689502|NCT00547157|142895150|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.278||||0.807|TWO_SIDED|95.0|0.438|4.043|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.|||4.043|0.438|0.8070
71689503|NCT00547157|142895150|SUPERIORITY_OR_OTHER||Difference in complete response rate|0.029|||||TWO_SIDED|95.0|-0.103|0.141|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.|||0.141|-0.103|
71926300|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.46|||<|0.001|TWO_SIDED|95.0|-0.67|-0.24|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.24|-0.67|<0.001
71926301|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.54|||<|0.001|TWO_SIDED|95.0|-0.75|-0.32|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Non-high Density Lipoproteins Cholesterol||-0.32|-0.75|<0.001
71926302|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|0.09||||0.005|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.15|0.03|0.005
71926303|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|0.11|||<|0.001|TWO_SIDED|95.0|0.05|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|High Density Lipoproteins Cholesterol||0.17|0.05|<0.001
71926304|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.18|||<|0.001|TWO_SIDED|95.0|-0.26|-0.11|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.11|-0.26|<0.001
71926305|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.17|||<|0.001|TWO_SIDED|95.0|-0.25|-0.09|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Very Low Density Lipoproteins Cholesterol||-0.09|-0.25|<0.001
71926306|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.2||||0.031|TWO_SIDED|95.0|-0.38|-0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.02|-0.38|0.031
71926307|NCT01694849|143372510|SUPERIORITY||Difference in least square mean change|-0.24||||0.009|TWO_SIDED|95.0|-0.42|-0.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Low Density Lipoproteins Cholesterol||-0.06|-0.42|0.009
71926308|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|5.73||||0.038|TWO_SIDED|95.0|0.31|11.14|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||11.14|0.31|0.038
71926309|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|7.07||||0.012|TWO_SIDED|95.0|1.59|12.55|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo A1||12.55|1.59|0.012
71926310|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-12.41|||<|0.001|TWO_SIDED|95.0|-17.56|-7.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-7.25|-17.56|<0.001
71926311|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-9.61|||<|0.001|TWO_SIDED|95.0|-14.81|-4.41|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo B||-4.41|-14.81|<0.001
71926312|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|3.55|||<|0.001|TWO_SIDED|95.0|2.14|4.96|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||4.96|2.14|<0.001
71926313|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|6.1|||<|0.001|TWO_SIDED|95.0|4.67|7.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo AII||7.53|4.67|<0.001
71926314|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-2.27|||<|0.001|TWO_SIDED|95.0|-3.29|-1.25|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-1.25|-3.29|<0.001
71926315|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.5||||0.004|TWO_SIDED|95.0|-2.52|-0.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII||-0.49|-2.52|0.004
71926316|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.78|||<|0.001|TWO_SIDED|95.0|-2.63|-0.92|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.92|-2.63|<0.001
71926317|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.15||||0.009|TWO_SIDED|95.0|-2.0|-0.29|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/B||-0.29|-2|0.009
71926318|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-0.46||||0.002|TWO_SIDED|95.0|-0.75|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.17|-0.75|0.002
71926319|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-0.39||||0.008|TWO_SIDED|95.0|-0.68|-0.1|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo CIII/nonB||-0.1|-0.68|0.008
71926320|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-2.35||||0.069|TWO_SIDED|95.0|-4.89|0.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||0.19|-4.89|0.069
71926321|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-3.39||||0.01|TWO_SIDED|95.0|-5.95|-0.84|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Small dense Low Density Lipoproteins||-0.84|-5.95|0.01
71926322|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|0.84||||0.549|TWO_SIDED|95.0|-1.93|3.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.61|-1.93|0.549
71926323|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|0.49||||0.728|TWO_SIDED|95.0|-2.28|3.26|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Lp(a)||3.26|-2.28|0.728
71926324|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.38|||<|0.001|TWO_SIDED|95.0|-2.14|-0.61|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.61|-2.14|<0.001
71926325|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.12||||0.004|TWO_SIDED|95.0|-1.89|-0.36|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E||-0.36|-1.89|0.004
71926326|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.18|||<|0.001|TWO_SIDED|95.0|-1.82|-0.53|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.53|-1.82|<0.001
71926327|NCT01694849|143372511|SUPERIORITY||Difference in least square mean change|-1.08||||0.001|TWO_SIDED|95.0|-1.72|-0.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Apo E/B||-0.43|-1.72|0.001
71926328|NCT01694849|143372512|SUPERIORITY||Difference in least square mean change|-2.8||||0.066|TWO_SIDED|95.0|-5.79|0.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Least square mean changes from baseline|||0.18|-5.79|0.066
71926329|NCT01694849|143372512|SUPERIORITY||Difference in least square mean change|0.77||||0.615|TWO_SIDED|95.0|-2.24|3.77|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.77|-2.24|0.615
71926330|NCT01694849|143372513|SUPERIORITY||Difference in least square mean change|-17.4||||0.307|TWO_SIDED|95.0|-50.88|16.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||16.08|-50.88|0.307
71926331|NCT01694849|143372513|SUPERIORITY||Difference in least square mean change|-21.41||||0.213|TWO_SIDED|95.0|-55.17|12.34|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.34|-55.17|0.213
71926332|NCT01694849|143372514|SUPERIORITY||Difference in least square mean change|-0.23||||0.003|TWO_SIDED|95.0|-0.37|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.08|-0.37|0.003
71926333|NCT01694849|143372514|SUPERIORITY||Difference in least square mean change|-0.14||||0.068|TWO_SIDED|95.0|-0.29|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.29|0.068
71926334|NCT01694849|143372515|SUPERIORITY||Difference in least square mean change|-0.8||||0.448|TWO_SIDED|95.0|-2.86|1.27|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.27|-2.86|0.448
71926335|NCT01694849|143372515|SUPERIORITY||Difference in least square mean change|-1.17||||0.267|TWO_SIDED|95.0|-3.25|0.9|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.9|-3.25|0.267
71926336|NCT01694849|143372516|SUPERIORITY||Difference in least square mean change|-0.05||||0.095|TWO_SIDED|95.0|-0.11|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.11|0.095
71926337|NCT01694849|143372516|SUPERIORITY||Difference in least square mean change|-0.07||||0.022|TWO_SIDED|95.0|-0.13|-0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-0.01|-0.13|0.022
71926338|NCT01694849|143372517|SUPERIORITY||Difference in least square mean change|-0.46||||0.077|TWO_SIDED|95.0|-0.96|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.96|0.077
71926339|NCT01694849|143372517|SUPERIORITY||Difference in least square mean change|-0.36||||0.172|TWO_SIDED|95.0|-0.87|0.16|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.16|-0.87|0.172
71926340|NCT01694849|143372518|SUPERIORITY||Difference in least square mean change|-0.04||||0.732|TWO_SIDED|95.0|-0.24|0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.17|-0.24|0.732
71926341|NCT01694849|143372518|SUPERIORITY||Difference in least square mean change|-0.2||||0.062|TWO_SIDED|95.0|-0.4|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.4|0.062
71926342|NCT01694849|143372519|SUPERIORITY||Difference in least square mean change|3.66||||0.4|TWO_SIDED|95.0|-4.89|12.2|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||12.2|-4.89|0.4
71926343|NCT01694849|143372519|SUPERIORITY||Difference in least square mean change|-16.22|||<|0.001|TWO_SIDED|95.0|-24.99|-7.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||-7.44|-24.99|<0.001
71926344|NCT01694849|143372520|SUPERIORITY||Difference in least square mean change|-0.36|||<|0.001|TWO_SIDED|95.0|-0.54|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Fibrinogen||-0.17|-0.54|<0.001
71926345|NCT01694849|143372520|SUPERIORITY||Difference in least square mean change|-0.27||||0.005|TWO_SIDED|95.0|-0.46|-0.08|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors||Fibrinogen|Standard error of the least square mean|-0.08|-0.46|0.005
71926346|NCT01694849|143372520|SUPERIORITY||Difference in least square mean change|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.15|-0.35|<0.001
71926347|NCT01694849|143372520|SUPERIORITY||Difference in least square mean change|-0.27|||<|0.001|TWO_SIDED|95.0|-0.37|-0.17|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Haptoglobin||-0.17|-0.37|<0.001
71926348|NCT01694849|143372521|SUPERIORITY||Difference in least square mean change|0.57||||0.742|TWO_SIDED|95.0|-2.9|4.06|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||4.06|-2.9|0.742
71926349|NCT01694849|143372521|SUPERIORITY||Difference in least square mean change|2.9||||0.107|TWO_SIDED|95.0|-0.63|6.43|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Tumour Necrosis Factor alpha||6.43|-0.63|0.107
71926350|NCT01694849|143372521|SUPERIORITY||Difference in least square mean change|0.5||||0.362|TWO_SIDED|95.0|-0.58|1.59|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.59|-0.58|0.362
71926351|NCT01694849|143372521|SUPERIORITY||Difference in least square mean change|0.07||||0.894|TWO_SIDED|95.0|-1.03|1.18|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|Interleukine 6||1.18|-1.03|0.894
71926352|NCT01694849|143372522|SUPERIORITY||Difference in least square mean change|-0.76||||0.229|TWO_SIDED|95.0|-2.0|0.48|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.48|-2|0.229
71926353|NCT01694849|143372522|SUPERIORITY||Difference in least square mean change|-0.45||||0.463|TWO_SIDED|95.0|-1.67|0.76|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.76|-1.67|0.463
71926354|NCT01694849|143372523|SUPERIORITY||Difference in least square mean change|-0.21||||0.065|TWO_SIDED|95.0|-0.42|0.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.01|-0.42|0.065
71926355|NCT01694849|143372523|SUPERIORITY||Difference in least square mean change|-0.19||||0.098|TWO_SIDED|95.0|-0.41|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|-0.41|0.098
71926356|NCT01694849|143372524|SUPERIORITY||Difference in least square mean change|0.7||||0.553|TWO_SIDED|95.0|-1.61|3.01|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.01|-1.61|0.553
71926357|NCT01694849|143372524|SUPERIORITY||Difference in least square mean change|4.31|||<|0.001|TWO_SIDED|95.0|1.97|6.64|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||6.64|1.97|<0.001
71926358|NCT01694849|143372525|SUPERIORITY||Difference in least square mean change|0.04||||0.861|TWO_SIDED|95.0|-0.37|0.44|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.44|-0.37|0.861
71926359|NCT01694849|143372525|SUPERIORITY||Difference in least square mean change|-0.4||||0.052|TWO_SIDED|95.0|-0.81|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|-0.81|0.052
71926360|NCT01694849|143372526|SUPERIORITY||Difference in least square mean change|0.01||||0.473|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.02|-0.01|0.473
71926361|NCT01694849|143372526|SUPERIORITY||Difference in least square mean change|0.01||||0.124|TWO_SIDED|95.0|0.0|0.03|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.03|0|0.124
71926362|NCT01694849|143372527|SUPERIORITY||Difference in least square mean change|0.81|||<|0.001|TWO_SIDED|95.0|0.47|1.15|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.15|0.47|<0.001
71926363|NCT01694849|143372527|SUPERIORITY||Difference in least square mean change|0.85|||<|0.001|TWO_SIDED|95.0|0.5|1.19|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.19|0.5|<0.001
71926364|NCT01694849|143372528|SUPERIORITY||Difference in least square mean change|0.0||||0.842|TWO_SIDED|95.0|-0.04|0.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.04|-0.04|0.842
71926365|NCT01694849|143372528|SUPERIORITY||Difference in least square mean change|0.01||||0.589|TWO_SIDED|95.0|-0.03|0.05|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0.05|-0.03|0.589
71926366|NCT01694849|143372529|SUPERIORITY||Difference in least square mean change|48.93||||0.325|TWO_SIDED|95.0|-8.73|146.6|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||146.6|-8.73|0.325
71926367|NCT01694849|143372529|SUPERIORITY||Difference in least square mean change|93.21||||0.066|TWO_SIDED|95.0|-6.06|192.49|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||192.49|-6.06|0.066
71926368|NCT01694849|143372530|SUPERIORITY||Difference in least square mean change|2.41|||<|0.001|TWO_SIDED|95.0|1.1|3.72|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||3.72|1.1|<0.001
71926369|NCT01694849|143372530|SUPERIORITY||Difference in least square mean change|1.59||||0.019|TWO_SIDED|95.0|0.26|2.91|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||2.91|0.26|0.019
71926370|NCT01694849|143372531|SUPERIORITY||Difference in least square mean change|0.0||||0.447|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.447
71926371|NCT01694849|143372531|SUPERIORITY||Difference in least square mean change|0.0||||0.758|TWO_SIDED|95.0|0.0|0.0|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||0|0|0.758
71926372|NCT01694849|143372532|SUPERIORITY||Difference in least square mean change|-0.04||||0.942|TWO_SIDED|95.0|-1.12|1.04|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.04|-1.12|0.942
71926373|NCT01694849|143372532|SUPERIORITY||Difference in least square mean change|0.57||||0.304|TWO_SIDED|95.0|-0.52|1.66|||Mixed Models Analysis|Baseline parameter value and presence of diabetes as random factors|Standard error of the least square mean|||1.66|-0.52|0.304
71689504|NCT01151345|142895204|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|88.65|||||TWO_SIDED|90.0|81.23|96.75||||||Natural-log transformed AUC (0-t) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||96.75|81.23|
71689505|NCT01151345|142895205|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|91.26|||||TWO_SIDED|90.0|83.83|99.34||||||Natural-log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||99.34|83.83|
71689506|NCT01151345|142895206|SUPERIORITY_OR_OTHER||Adjusted geometric means ratio|83.25|||||TWO_SIDED|90.0|67.08|103.31||||||Natural-log transformed Cmax was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.||103.31|67.08|
71689507|NCT01129804|142895224|SUPERIORITY|Longitudinal Linear mixed modeling|Slope|0.1|||<|0.04|TWO_SIDED|||||Tested the null hypothesis that slopes of PDA over time would not differ between treatment conditions, as indicated by the significance of the Treatment main effect and Treatment X Time interaction effect, at the level of p \< .05.|Mixed Models Analysis||||Multilevel longitudinal modeling (MLM) with random effects and maximum likelihood estimation (Proc MIXED; SAS Institute, 1999) was used to evaluate the effects of treatment over time for each of the continuously scaled outcome variables described above. The MLM approach was used because it employs maximum likelihood estimation of covariance matrices rather than raw data, allowing us to take advantage of all data collected for anyone randomized to treatment. Each repeated dependent variable was analyzed as a unction of treatment condition, time since intake (in months), and the interaction of treatment condition by time.|||<.04
71689508|NCT02259699|142895238|SUPERIORITY|||||||0.582|||||||t-test, 2 sided|||Difference between arms at T1||||0.582
71689509|NCT02259699|142895238|SUPERIORITY|||||||0.053|||||||t-test, 2 sided|||Difference between arms at T3||||0.053
71689510|NCT02259699|142895238|SUPERIORITY|||||||0.288|||||||t-test, 2 sided|||Difference between arms at T4||||0.288
71689511|NCT02259699|142895239|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||Difference between arms at T3||||0.087
71926374|NCT00908375|143372537|NON_INFERIORITY_OR_EQUIVALENCE|Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.|Median Difference (Final Values)|-2.0||||0.279|TWO_SIDED|99.0|-6.0|3.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||3|-6|0.279
71926375|NCT00908375|143372538|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-1.0||||0.282|TWO_SIDED|99.0|-2.0|1.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||1.0|-2.0|0.282
71926376|NCT00908375|143372539|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-16.0||||0.139|TWO_SIDED|99.0|-42.0|16.0||The criterion for rejection of the null hypothesis (P \< 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)|||||16|-42|0.139
71926377|NCT00463385|143372556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.092||95.0|||||Fisher Exact|||||||0.092
71926378|NCT00463385|143372556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.048||95.0|||||Fisher Exact|||||||0.048
71689512|NCT02259699|142895239|SUPERIORITY|||||||0.91|||||||t-test, 2 sided|||Difference between arms at T4||||0.910
71689513|NCT02259699|142895240|SUPERIORITY|||||||0.807|||||||t-test, 2 sided|||||||0.807
71689514|NCT02259699|142895241|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Difference between arms at T3||||0.071
71689515|NCT02259699|142895241|SUPERIORITY|||||||0.332|||||||t-test, 2 sided|||Difference between arms at T4||||0.332
71689516|NCT02259699|142895242|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||Difference between arms at T3||||0.177
71689517|NCT02259699|142895242|SUPERIORITY|||||||0.745|||||||t-test, 2 sided|||Difference between arms at T4||||0.745
71689518|NCT02432209|142895275|SUPERIORITY||Risk Ratio (RR)|0.81||||0.404|TWO_SIDED|95.0|0.48|1.34|||Chi-squared|||||1.34|0.48|0.404
71689519|NCT01087203|142895304|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.53||0.025|TWO_SIDED|95.0|-2.28|-0.16|||ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.16|-2.28|0.025
71689520|NCT01087203|142895305|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.332|TWO_SIDED|95.0|-0.92|0.32|||ANCOVA|||Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.32|-0.92|0.332
71689521|NCT01087203|142895305|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.38||0.297|TWO_SIDED|95.0|-1.15|0.36|||ANCOVA|||Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||0.36|-1.15|0.297
71689522|NCT01087203|142895305|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.95|STANDARD_ERROR_OF_MEAN|0.42||0.029|TWO_SIDED|95.0|-1.81|-0.1|||ANCOVA|||Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.10|-1.81|0.029
71689523|NCT01087203|142895305|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.46||0.01|TWO_SIDED|95.0|-2.17|-0.3|||ANCOVA|||Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.30|-2.17|0.010
71689524|NCT01087203|142895305|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.32|STANDARD_ERROR_OF_MEAN|0.49||0.009|TWO_SIDED|95.0|-2.3|-0.34|||ANCOVA|||Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.34|-2.30|0.009
71689525|NCT01087203|142895305|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.31|STANDARD_ERROR_OF_MEAN|0.52||0.015|TWO_SIDED|95.0|-2.36|-0.27|||ANCOVA|||Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.||-0.27|-2.36|0.015
71689526|NCT03828214|142895331|SUPERIORITY||Mean Difference (Final Values)|2.4|STANDARD_DEVIATION|9.2||0.973|TWO_SIDED|||||a priori threshold for statistical significance was 0.05.|ANOVA|||C2, C3, C4 were compared to C1 the comparison condition.||||0.973
71926379|NCT00463385|143372556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.758||95.0|||||Fisher Exact|||||||0.758
71926380|NCT01366846|143372589|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
71926381|NCT01366846|143372589|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.004
71926382|NCT01366846|143372590|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of participants with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
71926383|NCT01366846|143372591|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.||||<0.001
71926384|NCT01366846|143372591|SUPERIORITY_OR_OTHER|||||||0.027|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.||||0.027
71926385|NCT01366846|143372592|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group across both the SPT-negative and SPT-positive strata.||||<0.001
71926386|NCT01366846|143372593|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
71926387|NCT01366846|143372594|SUPERIORITY_OR_OTHER|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.||||0.250
71926388|NCT04196023|143372614|SUPERIORITY|||||||0.2||||||p-value was calculated using GLM. Statistical significance was determined using an alpha level of 0.05.|general linear model|adjusted for age, sex, education and baseline overall MoCA score||||||0.20
71926389|NCT04196023|143372615|SUPERIORITY|||||||0.9||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.90
71926390|NCT04196023|143372616|SUPERIORITY|||||||0.01||||||p-value was calculated using GLM model. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.01
71926391|NCT04196023|143372617|SUPERIORITY|||||||0.05||||||p-value was calculated using GLM model and false discovery rate (FDR)-adjustment. Statistical significance was determined using an alpha level of 0.05.|general linear model|GLM model additionally adjusting for age, sex, education and baseline level.||||||0.05
71926392|NCT04359758|143372618|SUPERIORITY|||||||0.14|||||||Chi-squared|||The study was powered assuming 10% genetic testing uptake UC compared to 35% in ST. assuming these uptake rates and a two-tailed alpha of 0.05, a sample size of n=50 per arm would yield greater than 80% power.||||0.14
71926393|NCT04359758|143372618|SUPERIORITY||Odds Ratio (OR)|2.57||||0.039|TWO_SIDED|95.0|1.05|6.29|||Regression, Logistic|||Because education and marital status have been associated with genetic testing participation in prior research, we conducted a follow-up analysis in which we adjusted for education and marital status.||6.29|1.05|0.039
71926394|NCT04359758|143372619|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|101 degrees of freedom.||||||0.13
71926395|NCT04359758|143372620|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|df=102||||||0.78
71926396|NCT04359758|143372621|SUPERIORITY|||||||0.97|||||||ANCOVA|df = 1, 101||Analysis of PROMIS anxiety||||0.97
71926397|NCT04359758|143372621|SUPERIORITY|||||||0.34|||||||ANCOVA|df = 1, 101||Analysis of PROMIS Depression||||0.34
71926398|NCT00489411|143372711|SUPERIORITY_OR_OTHER||Mean Difference|0.73||||0.003|TWO_SIDED|95.0|0.26|1.2|||Wilcoxon (Mann-Whitney)|||||1.20|0.26|0.003
71926399|NCT00489411|143372712|SUPERIORITY_OR_OTHER||Mean Difference|4.4|||||TWO_SIDED|95.0|0.93|7.88||||||||7.88|0.93|
71926400|NCT00489411|143372713|SUPERIORITY_OR_OTHER||Mean Difference|1.58||||0.03|TWO_SIDED|95.0|0.15|3.0|||Wilcoxon (Mann-Whitney)|||||3.00|0.15|0.03
71926401|NCT00489411|143372714|SUPERIORITY_OR_OTHER||Mean difference|1.01|||||TWO_SIDED|95.0|0.36|1.65||||||||1.65|0.36|
71926402|NCT01283009|143372715|SUPERIORITY||Odds Ratio (OR)|0.9||||0.635|TWO_SIDED|95.0|0.58|1.4|||Mantel Haenszel|||||1.40|0.58|0.635
71926403|NCT04436497|143372716|SUPERIORITY||Disease Rate Ratio|1.08|STANDARD_DEVIATION|0.11|||TWO_SIDED|95.0|0.874|1.307||Posterior probability that the disease rate ratio (DRR) is less than 1 (i.e. zilucoplan slowed progression) was 0.2418. NOTE: p-value is not provided for Bayesian model.|Bayesian shared-parameter model|A Bayesian shared-parameter model of change in disease severity as measured by ALSFRS-R total score and mortality.|"DDR \<1 imply slowing of disease progression by zilucoplan relative to placebo. Note: reported Confidence Interval is actually a Bayesian credible interval."||The DRR parameter for active treatment represents the relative change to the rate of decline of ALSFRS-R and the rate of mortality of treated participant relative to a placebo participant. The estimated DRR can also be interpreted as the average rate of decline in function and mortality. The model includes covariates for baseline use of edaravone, baseline use of riluzole, months since onset of symptoms, and pre-baseline slope of ALSFRS-R, and random effects for regimen and participant-specific slopes.|1.307|0.874|
71926404|NCT04436497|143372718|SUPERIORITY||Mean Difference (Net)|-1.09|STANDARD_ERROR_OF_MEAN|1.819||0.5495|TWO_SIDED|95.0|-4.66|2.48|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||2.48|-4.66|0.5495
71926405|NCT04436497|143372719|SUPERIORITY||Mean Difference (Net)|-1.04|STANDARD_ERROR_OF_MEAN|3.409||0.7602|TWO_SIDED|95.0|-7.73|5.65|||Mixed Models Analysis|Covariates include baseline use of edaravone and riluzole, months since symptom onset, and pre-baseline ALSFRS-R slope.|Zilucoplan 24-week change from baseline relative to placebo 24-week change from baseline.|||5.65|-7.73|0.7602
71926406|NCT04436497|143372720|SUPERIORITY|||||||0.6891|||||||Log Rank|||||||0.6891
71926407|NCT00505765|143372724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.5||0.21|TWO_SIDED||||||ANCOVA|||||||0.21
71926408|NCT00505765|143372724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2|STANDARD_DEVIATION|1.5||0.44|TWO_SIDED||||||ANCOVA|||||||0.44
71926409|NCT01207219|143372729|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||The p-value for statistical significance in these analyses was 0.01 adjusted for multiple comparisons .|Mixed Models Analysis|mixed-model analysis with a repeated-measures approach including an unstructured variance matrix||Data analysis was based on the Intention-to-Treatment (ITT) method. Differences between the three intervention groups over time (baseline and 12 weeks) were assessed with a Group x Time interaction term. A priori comparisons of the active intervention groups with the waitlist group were carried out with the same strategy if analyses including all the three groups meet the criterion of statistical significance (P\<0.01).||||<0.01
71926410|NCT00694070|143372734|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%."||||||0.0421|||||||Exact binomial test|||||||0.0421
71926411|NCT00694070|143372735|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%."||||||0.0309|||||||Exact binomial test|||||||0.0309
71926412|NCT00694070|143372736|NON_INFERIORITY_OR_EQUIVALENCE|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} \< Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%."||||||0.0309|||||||Exact binomial test|||||||0.0309
71926413|NCT00480077|143372749|SUPERIORITY|The primary end point of the study, all-cause death or hospitalization for heart failure, was analyzed on a time-to-first-event basis with the log-rank test. The hazard ratio (HR) associated with allocation to the access arm relative to control was estimated with corresponding 95% confidence interval (CI) by fitting a Cox proportional hazards model containing the treatment group as a categorical factor.||||||0.063|||||||Log Rank|||||||0.063
71689527|NCT00305565|142895335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.34||||0.803|TWO_SIDED|95.0|-2.34|3.02|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.02|-2.34|0.803
71926414|NCT01683565|143372798|OTHER|Analyses compared the change in Pervasive Developmental Disorders Screening Test-II scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.67||||||Threshold for statistical significance (\<0.05)|Mixed Models Analysis|||The sample size was determined based on the goal of confirming trial feasibility and estimating effect sizes for a full-scale trial, not for a definitive test of efficacy. The enrollment goal was 40, which would have provided an indication of an expected effect size for a larger full-scale trial (e.g., 53% power to detect a 2-point decrease (approximately 0.7-SD based on a prior study) in Pervasive Developmental Disorders Screening Test-II score). Funding limitations capped enrollment at 31.||||0.67
71926415|NCT01683565|143372799|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.22||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Competence scores between groups (LCPUFA vs. Placebo).||||0.22
71926416|NCT01683565|143372799|OTHER|Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes||||||0.92||||||Threshold for statistical significance (\<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo).||||0.92
71926417|NCT01683565|143372799|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.88|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo).||||0.88
71926418|NCT01683565|143372799|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.23|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo).||||0.23
71926419|NCT01683565|143372799|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.91|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo).||||0.91
71926420|NCT01683565|143372799|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.03|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo).||||0.03
71926421|NCT01683565|143372799|OTHER|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.07|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo).||||0.07
71926422|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.31||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (10:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.31
71926423|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.47||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.47
71926424|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.38||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.38
71926425|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
71926426|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.16||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.16
71926427|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
71926428|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.02
71926429|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.21||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.21
71926430|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.34||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.34
71926431|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.24||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.24
71689528|NCT00305565|142895335|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.813|TWO_SIDED|95.0|-2.39|3.05|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.||3.05|-2.39|0.813
71926432|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.5||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo).||||0.50
71926433|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.07||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.07
71926434|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.10
71926435|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
71926436|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.71||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.71
71926437|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo).||||0.001
71926438|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo).||||0.10
71926439|NCT01683565|143372800|OTHER|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values \<0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo).||||0.10
71926440|NCT05261126|143372811|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-41.2|||<|0.001|TWO_SIDED|95.0|-47.8|-34.7|||cLDA||MK-0616 6 mg minus Placebo|||-34.7|-47.8|<0.001
71926441|NCT05261126|143372811|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.7|||<|0.001|TWO_SIDED|95.0|-62.3|-49.1|||cLDA||MK-0616 12 mg minus Placebo|||-49.1|-62.3|<0.001
71926442|NCT05261126|143372811|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-59.1|||<|0.001|TWO_SIDED|95.0|-65.7|-52.5|||cLDA||MK-0616 18 mg minus Placebo|||-52.5|-65.7|<0.001
71926443|NCT05261126|143372811|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-60.9|||<|0.001|TWO_SIDED|95.0|-67.6|-54.3|||cLDA||MK-0616 30 mg minus Placebo|||-54.3|-67.6|<0.001
71926444|NCT05261126|143372812|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|0.2|||||TWO_SIDED|95.0|-15.5|15.8|||||MK-0616 6 mg minus Placebo|||15.8|-15.5|
71926445|NCT05261126|143372812|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-4.5|||||TWO_SIDED|95.0|-20.0|11.2|||||MK-0616 12 mg vs Placebo|||11.2|-20.0|
71926446|NCT05261126|143372812|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-0.6|||||TWO_SIDED|95.0|-16.3|15.1|||||MK-0616 18 mg vs Placebo|||15.1|-16.3|
71926447|NCT05261126|143372812|OTHER|Difference in percentage based on Miettinen \& Nurminen method.|Difference in Percentage|-1.9|||||TWO_SIDED|95.0|-17.5|13.8|||||MK-0616 30 mg minus Placebo|||13.8|-17.5|
71926448|NCT05261126|143372814|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-32.8|||<|0.001|TWO_SIDED|95.0|-38.6|-26.9|||cLDA||MK-0616 6 mg minus Placebo|||-26.9|-38.6|<0.001
71926449|NCT05261126|143372814|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-45.8|||<|0.001|TWO_SIDED|95.0|-51.7|-39.9|||cLDA||MK-0616 12 mg minus Placebo|||-39.9|-51.7|<0.001
71926450|NCT05261126|143372814|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-48.7|||<|0.001|TWO_SIDED|95.0|-54.6|-42.8|||cLDA||MK-0616 18 mg minus Placebo|||-42.8|-54.6|<0.001
71926451|NCT05261126|143372814|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Square Means|-51.8|||<|0.001|TWO_SIDED|95.0|-57.7|-45.9|||cLDA||MK-0616 30 mg minus Placebo|||-45.9|-57.7|<0.001
71926452|NCT05261126|143372815|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-35.9|||<|0.001|TWO_SIDED|95.0|-42.4|-29.4|||cLDA||MK-0616 6 mg minus Placebo|||-29.4|-42.4|<0.001
71689529|NCT03162328|142895399|SUPERIORITY|||||||0.363|||||||Wilcoxon Signed Ranks Test|||||||0.363
71689530|NCT03162328|142895400|SUPERIORITY|||||||0.291|||||||Wilcoxon Signed Ranks Test|||||||0.291
71926453|NCT05261126|143372815|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-50.5|||<|0.001|TWO_SIDED|95.0|-57.0|-44.0|||cLDA||MK-0616 12 mg minus Placebo|||-44.0|-57.0|<0.001
71926454|NCT05261126|143372815|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-53.2|||<|0.001|TWO_SIDED|95.0|-59.7|-46.7|||cLDA||MK-0616 18 mg minus Placebo|||-46.7|-59.7|<0.001
71926455|NCT05261126|143372815|SUPERIORITY|One-sided p-value and difference in least squares means based on a cLDA model including terms for treatment, time, baseline statin intensity, baseline renal function, and the interaction of treatment by time.|Difference in Least Squares Means|-55.8|||<|0.001|TWO_SIDED|95.0|-62.3|-49.3|||cLDA||MK-0616 30 mg minus Placebo|||-49.3|-62.3|<0.001
71926456|NCT05261126|143372816|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|69.2|||<|0.001|TWO_SIDED|95.0|56.2|79.0|||Miettinen & Nurminen||MK-0616 6 mg minus Placebo|||79.0|56.2|<0.001
71926457|NCT05261126|143372816|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|75.2|||<|0.001|TWO_SIDED|95.0|62.9|84.0|||Miettinen & Nurminen method||MK-0616 12 mg minus Placebo|||84.0|62.9|<0.001
71926458|NCT05261126|143372816|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.2|||<|0.001|TWO_SIDED|95.0|67.1|87.1|||Miettinen & Nurminen method||MK-0616 18 mg minus Placebo|||87.1|67.1|<0.001
71926459|NCT05261126|143372816|SUPERIORITY|One-sided p-value and difference in percentage based on Miettinen \& Nurminen method, with sample size weighting, stratified by background statin intensity.|Difference in Percentage|79.5|||<|0.001|TWO_SIDED|95.0|67.9|87.4|||Miettinen & Nurminen method||MK-0616 30 mg minus Placebo|||87.4|67.9|<0.001
71926460|NCT03901274|143372817|SUPERIORITY||Slope|-0.16|STANDARD_ERROR_OF_MEAN|0.29|||TWO_SIDED|95.0|-0.74|0.42|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on three month outcomes with intake (i.e. Pretest covariate)||0.42|-0.74|
71926461|NCT03901274|143372817|SUPERIORITY||Slope|-0.65|STANDARD_ERROR_OF_MEAN|0.28|||TWO_SIDED|95.0|-1.2|-0.09|||||Parameter estimated with full information maximum likelihood|Intent-to-treat on six month outcomes with intake (i.e. Pretest covariate)||-0.09|-1.20|
71926462|NCT00145119|143372853|SUPERIORITY_OR_OTHER_LEGACY||proportion (%)|8.0||||||||||||||||||
71926463|NCT03671746|143372870|SUPERIORITY||Median Difference (Final Values)|1.5|STANDARD_DEVIATION|1.5|=|0.275|TWO_SIDED||||||ANOVA|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using Length of Stay (LOS) as this was the primary outcome. Using a significance level of 0.05 and assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||=0.275
71926464|NCT03671746|143372871|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed using LOS as this was the primary outcome. Using a significance level of 0.05 and an assumed standard deviation of 1.5 days, a sample size of 42 patients/group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients/group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
71926465|NCT03671746|143372872|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|The VAS model was adjusted for baseline levels as a covariate, which differed significantly between groups.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).||||<0.05
71926466|NCT03671746|143372873|SUPERIORITY||||||=|0.564|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.564
71926467|NCT03671746|143372874|SUPERIORITY||||||=|0.118|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.118
71926468|NCT03671746|143372875|SUPERIORITY|||||||0.215|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||0.215
71926469|NCT03671746|143372876|SUPERIORITY||||||=|0.043|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.043
71926470|NCT03671746|143372877|SUPERIORITY||||||=|0.617|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||=0.617
71926471|NCT03671746|143372879|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|A Kenward-Roger adjustment was used to correct for negative bias in the standard errors and degrees of freedom calculations.||Sample size calculations were performed regarding LOS as this was the primary outcome measure. Using a significance level of 0.05 and an assumed SD of 1.5 days, a sample size of 42 patients per group (84 total) would yield 80% power to detect a difference of 0.928 days in average LOS between groups. Allowing for a dropout rate of up to 25%, recruitment was originally planned for 56 patients per group. Power calculations were performed using nQuery 8.5 (Statistical Solutions Ltd; Cork, Ireland).|Group-level summary statistics were calculated for demographic and clinical variables, and differences between groups were evaluated using two-sample t-tests for quantitative measures and Fisher's exact tests for categorical measures, as appropriate. Time and group comparisons for each cytokine were made using linear mixed models, with and without adjusting for selected covariates. Patient demographic variables and clinical outcomes of interest were considered for inclusion as covariates in each model but were only retained if they significantly improved the model. Linear mixed models were log-transformed, double-log-transformed, or square-root-transformed to correct for right skewness, as appropriate. Likelihood ratio testing and Akaike information criterion were used to select appropriate covariance structures in each case. All analyses were completed in SAS 9.4 (SAS Institute Inc.; Cary, NC, USA).|||<0.05
71926472|NCT04410991|143372916|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|0.996||||0.9758|TWO_SIDED|95.0|0.754|1.315||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.315|0.754|0.9758
71926473|NCT04410991|143372917|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.582||||0.0114|TWO_SIDED|95.0|0.38|0.891||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.891|0.380|0.0114
71926474|NCT04410991|143372918|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.641||||0.0181|TWO_SIDED|95.0|0.444|0.925||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||0.925|0.444|0.0181
71926475|NCT04410991|143372919|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.165||||0.2362|TWO_SIDED|95.0|0.905|1.502|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.502|0.905|0.2362
71926476|NCT04410991|143372920|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|2.118|||<|0.0001|TWO_SIDED|95.0|1.502|2.987|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.987|1.502|<0.0001
71926477|NCT04410991|143372921|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|-0.053||||0.31|TWO_SIDED|95.0|-0.156|0.05|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.050|-0.156|0.3100
71926478|NCT04410991|143372922|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|-0.612||||0.5235|TWO_SIDED|95.0|-2.493|1.269|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||1.269|-2.493|0.5235
71926479|NCT04410991|143372923|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|1.652||||0.0079|TWO_SIDED|95.0|1.145|2.383||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||2.383|1.145|0.0079
71926480|NCT04410991|143372924|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.044||||0.4266|TWO_SIDED|95.0|-0.065|0.153|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.153|-0.065|0.4266
71926481|NCT05966129|143372969|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7957|TWO_SIDED|95.0|-18.3|23.8|||t-test, 2 sided||||Confidence Interval Width = 42.1|23.8|-18.3|0.7957
71926482|NCT05966129|143372970|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.8255|TWO_SIDED|95.0|-0.4|0.5|||t-test, 2 sided||||Confidence Interval Width = 0.9|0.5|-0.4|0.8255
71926483|NCT05966129|143372971|SUPERIORITY|||||||0.9054|||||||Wilcoxon (Mann-Whitney)|||||||0.9054
71926484|NCT05966129|143372972|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.248|TWO_SIDED|95.0|-1.9|0.5|||t-test, 2 sided||||Confidence Interval Width = 2.4|0.5|-1.9|0.248
71926485|NCT05966129|143372973|SUPERIORITY||Mean Difference (Final Values)|1.0||||0.6012|TWO_SIDED|95.0|-2.7|4.7|||t-test, 2 sided||||Confidence Interval Width = 7.4|4.7|-2.7|0.6012
71926486|NCT05966129|143372974|SUPERIORITY|||||||0.7528|||||||Chi-squared|||||||0.7528
71926487|NCT05966129|143372975|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71926488|NCT01298323|143372976|SUPERIORITY_OR_OTHER_LEGACY||t-Statistic|1.29||||0.199|TWO_SIDED|95.0|-3.44|16.37||Statistical significance threshold at this analysis was 10%|t-test, 2 sided|||||16.37|-3.44|0.199
71926489|NCT00931515|143373004|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71689531|NCT01680653|142895465|SUPERIORITY_OR_OTHER|||||||0.106||||||In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P\<0.05.|Wilcoxon (Mann-Whitney)|||The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of \<70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for \> or = 25 minutes.||||0.106
71926490|NCT01375491|143373049|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05||95.0||||See published paper.|ANOVA|See published paper.||See published paper.||||<0.05
71926491|NCT01740297|143373185|SUPERIORITY||Odds Ratio (OR)|2.9||||0.002|TWO_SIDED|95.0|1.5|5.5|||Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.5|1.5|0.002
71926492|NCT01740297|143373188|OTHER||Odds Ratio (OR)|1.9||||0.033|TWO_SIDED|95.0|1.1|3.4||P-value is descriptive|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||3.4|1.1|0.033
71926493|NCT01740297|143373189|OTHER||Odds Ratio (OR)|2.8||||0.007|TWO_SIDED|95.0|1.4|5.8||P-value is descriptive.|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.|||5.8|1.4|0.007
71926494|NCT01740297|143373190|OTHER||Hazard Ratio (HR)|1.41||||0.228|TWO_SIDED|95.0|0.8|2.49||P-value is descriptive|Log Rank||Obtained from unstratified Cox Proportional Hazard Model.|||2.49|0.80|0.228
71689532|NCT01680653|142895466|SUPERIORITY_OR_OTHER|||||||0.078|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.078
71689533|NCT01680653|142895467|SUPERIORITY_OR_OTHER||Fisher's exact test|||||0.003|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This is the P value for the number of events \<70 mg/dL longer than one hour||||0.003
71689534|NCT01680653|142895467|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events \<70 mg/dL that were greater than 2 hours||||0.010
71689535|NCT01680653|142895467|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED||||||Fisher's exact test|||This is the p value for the number of events that were \<50 mg/dL for \> 30 minutes||||0.021
71926495|NCT01740297|143373192|OTHER||Hazard Ratio (HR)|0.83||||0.348|TWO_SIDED|95.0|0.56|1.23|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.23|0.56|0.348
71926496|NCT01740297|143373193|OTHER|||||||0.696|||||||Chi-squared, Corrected|||||||0.696
71926497|NCT01740297|143373194|OTHER||Hazard Ratio (HR)|0.8||||0.474|TWO_SIDED|95.0|0.44|1.46|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.46|0.44|0.474
71689536|NCT01680653|142895467|SUPERIORITY_OR_OTHER|||||||0.077|TWO_SIDED||||||Fisher's exact|||This is the P value for the number of events \<50 mg/dL that were \>1 hr||||0.077
71926498|NCT01740297|143373196|OTHER||Hazard Ratio (HR)|0.78||||0.14|TWO_SIDED|95.0|0.55|1.09|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.09|0.55|0.14
71926499|NCT01740297|143373197|OTHER||Hazard Ratio (HR)|0.83||||0.37|TWO_SIDED|95.0|0.56|1.24|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model|||1.24|0.56|0.37
71926500|NCT01966458|143373224|NON_INFERIORITY|A non-inferiority margin of 6% was pre-specified.|Risk Difference (RD)|2.6||||0.1444|TWO_SIDED|90.0|-5.5|10.7|||Farrington-Manning asymptotic test||Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.|The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.||10.7|-5.5|0.1444
71926501|NCT01966458|143373225|SUPERIORITY||Percent of Participants|19.2||||0.7363|TWO_SIDED|90.0|15.6|23.3|||Exact Binomial Test||Two-sided exact binomial confidence interval used|The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.||23.3|15.6|0.7363
71926502|NCT01966458|143373226|NON_INFERIORITY|The non-inferiority margin on the difference in success proportions is 15%.|Difference in Percentages|-9.2|||<|0.0001|TWO_SIDED|90.0|-17.2|-1.1|||Farrington-Manning asymptotic test||Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used|||-1.1|-17.2|<0.0001
71926503|NCT01966458|143373226|SUPERIORITY|||||||0.0354|||||||Chi-squared|||||||0.0354
71926504|NCT02389621|143373227|SUPERIORITY||Difference|36.7|||<|0.0001|TWO_SIDED|95.0|24.9|48.5||Statistical tests were performed at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted using the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||48.5|24.9|<0.0001
71926505|NCT02389621|143373228|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|34.8|||<|0.0001|TWO_SIDED|95.0|22.8|46.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||46.8|22.8|<0.0001
71926506|NCT02389621|143373229|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|52.5|||<|0.0001|TWO_SIDED|95.0|42.0|62.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.||||62.9|42.0|<0.0001
71689537|NCT03020550|142895485|SUPERIORITY|||||||0.034|||||||ANOVA|Adjusted for baseline GERD symptom severity.||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in GSR (galvanic skin response). No term for visit type assignment was included in the model.||||0.034
71689538|NCT03020550|142895486|SUPERIORITY|||||||0.56|||||||ANOVA|Adjusted for baseline GERD symptom severity||The outcome measure was calculated using a general linear model with average daily post GERD symptom severity as the dependent variable with the following independent variables: baseline average GERD symptom severity and change in RMSSD (high frequency HRV). No term for visit type assignment was included in the model.||||0.56
71689539|NCT03020550|142895487|SUPERIORITY|||||||0.8|||||||Pearson's correlation test|||The outcome measure was calculated using a Pearson correlation to compare the session index representing the amount of concordance in GSR between patient and physician and the percent change in patients' GERD symptoms. Visit type assignment was not included in the analysis.||||0.80
71689540|NCT04378569|142895496|SUPERIORITY||Odds Ratio (OR)|1.11||||0.5788|TWO_SIDED|95.0|0.49|2.53|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.53|0.49|0.5788
71689541|NCT04378569|142895496|SUPERIORITY||Odds Ratio (OR)|0.84||||0.6488|TWO_SIDED|95.0|0.33|2.17|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.17|0.33|0.6488
71689542|NCT04378569|142895496|SUPERIORITY||Odds Ratio (OR)|0.85||||0.5653|TWO_SIDED|95.0|0.32|2.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation used to handle missing data|||2.25|0.32|0.5653
71689543|NCT04378569|142895497|SUPERIORITY||Odds Ratio (OR)|0.84||||0.5033|TWO_SIDED|95.0|0.25|2.78|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.78|0.25|0.5033
71689544|NCT04378569|142895497|SUPERIORITY||Odds Ratio (OR)|0.83||||0.4975|TWO_SIDED|95.0|0.25|2.79|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.79|0.25|0.4975
71926507|NCT02389621|143373230|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.||||||0.0002|||||||van Elteren test|van Elteren test stratified by platelet transfusion during the study.||||||0.0002
71926508|NCT02389621|143373231|SUPERIORITY|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|||||<|0.0001|||||||Wilcoxon rank sum test|||||||<0.0001
71926509|NCT01969201|143373278|NON_INFERIORITY|The non-inferiority was evaluated by calculating the 95% CI for the differences in pregnancy rates between the two treatment groups. If the lower bound of the 95% CI of the difference between the two proportions was greater than -0.10 (i.e. 10%), then Fostimon was to be considered not inferior to the control treatment.|Mean Difference (Final Values)|-2.73||||0.49|TWO_SIDED|95.0|-9.88|4.42|||Fisher Exact|||||4.42|-9.88|0.49
71926510|NCT01969201|143373279|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71926511|NCT01969201|143373280|OTHER|||||||0.02|||||||ANOVA|||||||0.02
71926512|NCT01969201|143373281|OTHER|||||||0.32|||||||ANOVA|||||||0.32
71926513|NCT01969201|143373282|OTHER|||||||0.89|||||||ANOVA|||||||0.89
71926514|NCT01969201|143373283|OTHER|||||||0.5|||||||Fisher Exact|||||||0.5
71926515|NCT01969201|143373284|OTHER|||||||0.53|||||||Fisher Exact|||||||0.53
71926516|NCT01969201|143373285|OTHER|||||||0.07|||||||Fisher Exact|||||||0.07
71926517|NCT01422876|143373299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.75|-0.41|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.41|-0.75|<0.0001
71926518|NCT01422876|143373299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.67|-0.32|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.32|-0.67|<0.0001
71926519|NCT01422876|143373299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.59|-0.25|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.25|-0.59|<0.0001
71926520|NCT01422876|143373299|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|95.0|-0.56|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p\<0.0001), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.56|<0.0001
71926521|NCT01422876|143373300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.43|STANDARD_ERROR_OF_MEAN|3.54|<|0.0001|TWO_SIDED|95.0|-23.37|-9.48|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-9.48|-23.37|<0.0001
71926522|NCT01422876|143373300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.2|STANDARD_ERROR_OF_MEAN|3.62|<|0.0001|TWO_SIDED|95.0|-29.3|-15.1|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-15.10|-29.30|<0.0001
71926523|NCT01422876|143373300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.34|STANDARD_ERROR_OF_MEAN|3.55||0.0015|TWO_SIDED|95.0|-18.31|-4.37|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-4.37|-18.31|0.0015
71926524|NCT01422876|143373300|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-19.12|STANDARD_ERROR_OF_MEAN|3.61|<|0.0001|TWO_SIDED|95.0|-26.21|-12.03|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p\<0.0001) as fixed effect(s).||-12.03|-26.21|<0.0001
71926525|NCT01422876|143373301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.31|STANDARD_ERROR_OF_MEAN|3.78||0.1605|TWO_SIDED|95.0|-12.74|2.11|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||2.11|-12.74|0.1605
71926526|NCT01422876|143373301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.82|STANDARD_ERROR_OF_MEAN|3.78||0.1246|TWO_SIDED|95.0|-13.25|1.61|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||1.61|-13.25|0.1246
71926527|NCT01422876|143373301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-23.63|STANDARD_ERROR_OF_MEAN|3.78|<|0.0001|TWO_SIDED|95.0|-31.06|-16.21|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-16.21|-31.06|<0.0001
71689545|NCT04378569|142895497|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||P value was not evaluable|Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|Stratified by pooled site group and baseline IGA score with multiple imputation to handle missing data|||2.55|0.04|
71926528|NCT01422876|143373301|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-22.29|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001|TWO_SIDED|95.0|-29.71|-14.88|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p\<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p\<0.0001) as fixed effect(s).||-14.88|-29.71|<0.0001
71926529|NCT01422876|143373302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.19|STANDARD_ERROR_OF_MEAN|0.43||0.6604|TWO_SIDED|95.0|-0.65|1.03||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||1.03|-0.65|0.6604
71926530|NCT01422876|143373302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-3.15|-1.44|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.44|-3.15|<0.0001
71926531|NCT01422876|143373302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.43||0.8757|TWO_SIDED|95.0|-0.91|0.77||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||0.77|-0.91|0.8757
71926532|NCT01422876|143373302|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.91|STANDARD_ERROR_OF_MEAN|0.44|<|0.0001|TWO_SIDED|95.0|-2.77|-1.05|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p\<0.0001) as fixed effect(s).||-1.05|-2.77|<0.0001
71926533|NCT01422876|143373303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.1785|TWO_SIDED|95.0|-0.33|0.06|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||0.06|-0.33|0.1785
71926534|NCT01422876|143373303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.21|-0.61|<0.0001
71926535|NCT01422876|143373303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.61|-0.22|||Cochran-Mantel-Haenszel|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.22|-0.61|<0.0001
71926536|NCT01422876|143373303|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.76|-0.37|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p\<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p\<0.0001) as fixed effect(s).||-0.37|-0.76|<0.0001
71926537|NCT01422876|143373304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.51||0.801|TWO_SIDED|95.0|-0.88|1.14||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||1.14|-0.88|0.8010
71926538|NCT01422876|143373304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47|STANDARD_ERROR_OF_MEAN|0.51||0.3616|TWO_SIDED|95.0|-1.48|0.54||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||0.54|-1.48|0.3616
71926539|NCT01422876|143373304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.22|STANDARD_ERROR_OF_MEAN|0.51||0.0178|TWO_SIDED|95.0|-2.23|-0.21|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.21|-2.23|0.0178
71926540|NCT01422876|143373304|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|0.51||0.0001|TWO_SIDED|95.0|-2.97|-0.95|||ANCOVA|||Model for Week 24 includes baseline weight (p\<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).||-0.95|-2.97|0.0001
71926541|NCT01422876|143373305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.191|||<|0.0001|TWO_SIDED|95.0|2.319|7.573|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.573|2.319|<0.0001
71926542|NCT01422876|143373305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.474|8.184|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||8.184|2.474|<0.0001
71926543|NCT01422876|143373305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.495|||<|0.0001|TWO_SIDED|95.0|1.92|6.363|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||6.363|1.920|<0.0001
71926544|NCT01422876|143373305|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.795||||0.0005|TWO_SIDED|95.0|1.562|5.001|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.001|1.562|0.0005
71926545|NCT01422876|143373306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.893||||0.0224|TWO_SIDED|95.0|1.095|3.274|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||3.274|1.095|0.0224
71926546|NCT01422876|143373306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.961||||0.0001|TWO_SIDED|95.0|1.697|5.169|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.169|1.697|0.0001
71926547|NCT01422876|143373306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.065|||<|0.0001|TWO_SIDED|95.0|1.768|5.314|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||5.314|1.768|<0.0001
71926548|NCT01422876|143373306|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.303|||<|0.0001|TWO_SIDED|95.0|2.462|7.522|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.||7.522|2.462|<0.0001
71926549|NCT04640168|143373389|SUPERIORITY|||||||0.909|||||||Chi-squared|||||||0.909
71926550|NCT04640168|143373406|SUPERIORITY||Risk Difference (RD)|7.7|||||TWO_SIDED|95.0|1.8|13.4||||||||13.4|1.8|
71926551|NCT04640168|143373407|SUPERIORITY||Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-4.3|5.5||||||||5.5|-4.3|
71926552|NCT04640168|143373425|SUPERIORITY||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.8|1.27||||||||1.27|0.80|
71926553|NCT04640168|143373426|SUPERIORITY||Risk Difference (RD)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
71926554|NCT04640168|143373427|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
71926555|NCT04640168|143373428|SUPERIORITY||Hazard Ratio (HR)|1.08|||||TWO_SIDED|95.0|0.94|1.23||||||||1.23|0.94|
71926556|NCT04640168|143373429|SUPERIORITY||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.91|1.19||||||||1.19|0.91|
71926557|NCT00276458|143373482|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.9|STANDARD_ERROR_OF_MEAN|2.7|<|0.001||95.0|-25.2|-14.5|||ANCOVA|Model terms: treatment and baseline LDL-C value|(Atorva + EZ minus Atorva)|||-14.5|-25.2|<0.001
71926558|NCT00276458|143373483|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|2.1||0.273||95.0|-1.9|6.6|||ANCOVA|Model terms: treatment and baseline HDL-C value|(Atorva + EZ minus Atorva)|||6.6|-1.9|0.273
71926559|NCT00276458|143373484|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-21.2|-11.7|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|(Atorva + EZ minus Atorva)|||-11.7|-21.2|<0.001
71926560|NCT00276458|143373485|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|1.8|<|0.001||95.0|-15.8|-8.6|||ANCOVA|Model terms: treatment and baseline Total-C value|(Atorva + EZ minus Atorva)|||-8.6|-15.8|<0.001
71926561|NCT00276458|143373486|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-8.9||||0.159||95.0|-17.7|-0.4||ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value|Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||-0.4|-17.7|0.159
71926562|NCT00276458|143373487|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.7|STANDARD_ERROR_OF_MEAN|2.1|<|0.001||95.0|-17.8|-9.6|||ANCOVA|Model terms: treatment and baseline Apo B value|(Atorva + EZ minus Atorva)|||-9.6|-17.8|<0.001
71926563|NCT00276458|143373488|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|1.6||0.681||95.0|-3.9|2.6|||ANCOVA|Model terms: treatment and baseline Apo A-I value|(Atorva + EZ minus Atorva)|||2.6|-3.9|0.681
71926564|NCT00276458|143373489|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.2|<|0.001||95.0|-17.5|-8.7|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|(Atorva + EZ minus Atorva)|||-8.7|-17.5|<0.001
71926565|NCT00276458|143373490|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.001||95.0|-26.5|-15.3|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-15.3|-26.5|<0.001
71689546|NCT04378569|142895498|SUPERIORITY||Odds Ratio (OR)|0.75||||0.7237|TWO_SIDED|95.0|0.23|2.44|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.44|0.23|0.7237
71689547|NCT04378569|142895498|SUPERIORITY||Odds Ratio (OR)|0.59||||0.838|TWO_SIDED|95.0|0.17|2.1|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.10|0.17|0.8380
71689548|NCT04378569|142895498|SUPERIORITY||Odds Ratio (OR)|0.33|||||TWO_SIDED|95.0|0.04|2.55||p-value was unevaluable||Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|||2.55|0.04|
71689549|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9604|TWO_SIDED|95.0|0.31|3.07|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.07|0.31|0.9604
71689550|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|1.02||||0.9752|TWO_SIDED|95.0|0.32|3.25|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.25|0.32|0.9752
71689551|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.57||||0.5077|TWO_SIDED|95.0|0.11|3.03|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 2||3.03|0.11|0.5077
71689552|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.74||||0.5916|TWO_SIDED|95.0|0.26|2.15|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||2.15|0.26|0.5916
71689553|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.65||||0.332|TWO_SIDED|95.0|0.27|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.27|0.3320
71926566|NCT00276458|143373491|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.4|<|0.001||95.0|-17.9|-8.3|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|(Atorva + EZ minus Atorva)|||-8.3|-17.9|<0.001
71926567|NCT00276458|143373492|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.001||95.0|-23.2|-11.4|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|(Atorva + EZ minus Atorva)|||-11.4|-23.2|<0.001
71926568|NCT00276458|143373493|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.841||95.0|-23.8|28.8|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment|"Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.~(Atorva + EZ minus Atorva)"|||28.8|-23.8|0.841
71926569|NCT00276458|143373494|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.839||95.0|-26.1|8.3|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.~(Atorva + EZ minus Atorva)"|||8.3|-26.1|0.839
71689554|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.47||||0.1922|TWO_SIDED|95.0|0.14|1.57|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 4||1.57|0.14|0.1922
71689555|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.65||||0.4188|TWO_SIDED|95.0|0.23|1.81|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.81|0.23|0.4188
71689556|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.74||||0.552|TWO_SIDED|95.0|0.29|1.92|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||1.92|0.29|0.5520
71689557|NCT04378569|142895499|SUPERIORITY||Odds Ratio (OR)|0.69||||0.69|TWO_SIDED|95.0|0.21|2.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Stratified by pooled site group and baseline IGA score, with multiple imputation of missing data|Week 8||2.20|0.21|0.69
71689558|NCT04378569|142895500|SUPERIORITY|Week 2|Mean Difference (Net)|-0.06||||0.6464|TWO_SIDED|95.0|-0.33|0.21|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.21|-0.33|0.6464
71689559|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.8881|TWO_SIDED|95.0|-0.29|0.25|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.25|-0.29|0.8881
71689560|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.436|TWO_SIDED|95.0|-0.2|0.46|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 2||0.46|-0.20|0.4360
71689561|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.8196|TWO_SIDED|95.0|-0.29|0.36|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.36|-0.29|0.8196
71689562|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.02||||0.9217|TWO_SIDED|95.0|-0.31|0.34|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 4||0.34|-0.31|0.9217
71926570|NCT00276458|143373495|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|8.6|||<|0.001||95.0|3.8|19.47|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.|||19.47|3.80|<0.001
71926571|NCT00750373|143373496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.1|||<|0.05|TWO_SIDED|95.0|||||Fisher Exact|||We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.||||<0.05
71926572|NCT02276274|143373540|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
71926573|NCT02276274|143373541|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0592|0.0264|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0264|-0.0592|
71926574|NCT02276274|143373542|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.1182|||||TWO_SIDED|90.0|-0.0405|0.2769|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.2769|-0.0405|
71926575|NCT02276274|143373544|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0139|||||TWO_SIDED|90.0|-0.0598|0.032|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0320|-0.0598|
71926576|NCT02276274|143373559|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.014|||||TWO_SIDED|90.0|-0.0918|0.0638|||||ANOVA was performed on log-transformed values of AUC (0-48) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0638|-0.0918|
71926577|NCT02276274|143373560|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0164|||||TWO_SIDED|90.0|-0.0934|0.0605|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0605|-0.0934|
71926578|NCT02276274|143373562|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.1518|||||TWO_SIDED|90.0|-0.2356|-0.068|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||-0.0680|-0.2356|
71926579|NCT02276274|143373564|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.0179|||||TWO_SIDED|90.0|-0.095|0.0591|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.|||0.0591|-0.0950|
71926580|NCT01015118|143373623|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.84||||0.0239|TWO_SIDED|95.0|0.72|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).||0.98|0.72|0.0239
71926581|NCT01015118|143373624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.0286|TWO_SIDED|95.0|0.75|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.75|0.0286
71926582|NCT01015118|143373625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.0186|TWO_SIDED|95.0|0.72|0.97|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.97|0.72|0.0186
71926583|NCT01015118|143373626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0256|TWO_SIDED|95.0|0.74|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||0.98|0.74|0.0256
71926584|NCT01015118|143373627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.8653|TWO_SIDED|95.0|0.83|1.17|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.17|0.83|0.8653
71926585|NCT01015118|143373628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0749|TWO_SIDED|95.0|0.77|1.01|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.01|0.77|0.0749
71926586|NCT01015118|143373629|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.349|TWO_SIDED|95.0|0.81|1.82|||Regression, Logistic||An odds ratio \>1 favours nintedanib.|Odds ratio and p-value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).||1.82|0.81|0.3490
71926587|NCT01015118|143373630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.29|STANDARD_ERROR_OF_MEAN|0.72|<|0.0001|TWO_SIDED|95.0|3.88|6.69|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||6.69|3.88|<0.0001
71689563|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.4783|TWO_SIDED|95.0|-0.25|0.53|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|||0.53|-0.25|0.4783
71689564|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.7725|TWO_SIDED|95.0|-0.32|0.43|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.43|-0.32|0.7725
71689565|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.7861|TWO_SIDED|95.0|-0.43|0.33|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.33|-0.43|0.7861
71689566|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.3521|TWO_SIDED|95.0|-0.24|0.68|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 8||0.68|-0.24|0.3521
71926588|NCT01015118|143373631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.88|STANDARD_ERROR_OF_MEAN|0.75||0.0124|TWO_SIDED|95.0|-3.35|-0.41|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB-III vs IV), and carboplatin level (AUC5 vs. AUC6).||-0.41|-3.35|0.0124
71926589|NCT03522506|143373632|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The least squares mean (LSM) sleep latency for each treatment and the associated standard error and 95% confidence interval (CI) was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|Least square mean difference|20.06|||<|0.001|TWO_SIDED|95.0|13.35|26.77|||Linear mixed effect model|||||26.77|13.35|<0.001
71926590|NCT03522506|143373632|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|24.35|||<|0.001|TWO_SIDED|95.0|17.64|31.06|||Linear mixed effect model|||||31.06|17.64|<0.001
71926591|NCT03522506|143373632|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM Difference|19.89|||<|0.001|TWO_SIDED|95.0|13.3|26.49|||Linear mixed effects model|||||26.49|13.30|<0.001
71926592|NCT03522506|143373642|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.2||||0.664|TWO_SIDED|95.0|-1.13|0.73|||Linear mixed effect model|||||0.73|-1.13|0.664
71926593|NCT03522506|143373642|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.24||||0.605|TWO_SIDED|95.0|-0.69|1.17|||Linear mixed effect model|||||1.17|-0.69|0.605
71926594|NCT03522506|143373642|SUPERIORITY|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.574|TWO_SIDED|95.0|-1.17|0.66|||Linear mixed effect model|||||0.66|-1.17|0.574
71926595|NCT03522506|143373642|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.29||||0.483|TWO_SIDED|95.0|-0.53|1.11|||Linear mixed effect model|||||1.11|-0.53|0.483
71926596|NCT03522506|143373642|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.01||||0.972|TWO_SIDED|95.0|-0.81|0.84|||Linear mixed effect model|||||0.84|-0.81|0.972
71926597|NCT03522506|143373642|SUPERIORITY|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.18||||0.654|TWO_SIDED|95.0|-0.99|0.63|||Linear mixed effect model|||||0.63|-0.99|0.654
71926598|NCT03522506|143373642|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.01||||0.984|TWO_SIDED|95.0|-0.86|0.85|||Linear mixed effect model|||||0.85|-0.86|0.984
71926599|NCT03522506|143373642|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.29||||0.508|TWO_SIDED|95.0|-1.14|0.57|||Linear mixed effect model|||||0.57|-1.14|0.508
71926600|NCT03522506|143373642|SUPERIORITY|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.22||||0.605|TWO_SIDED|95.0|-1.06|0.62|||Linear mixed effect model|||||0.62|-1.06|0.605
71926601|NCT03522506|143373642|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.11||||0.847|TWO_SIDED|95.0|-1.06|1.29|||Linear mixed effect model|||||1.29|-1.06|0.847
71926602|NCT03522506|143373642|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.44||||0.455|TWO_SIDED|95.0|-1.61|0.73|||Linear mixed effect model|||||0.73|-1.61|0.455
71926603|NCT03522506|143373642|SUPERIORITY|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.58||||0.317|TWO_SIDED|95.0|-1.74|0.57|||Linear mixed effect model|||||0.57|-1.74|0.317
71926604|NCT03522506|143373642|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.0||||0.001|TWO_SIDED|95.0|-3.18|-0.83|||Linear mixed effect model|||||-0.83|-3.18|0.001
71926605|NCT03522506|143373642|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.61|||<|0.001|TWO_SIDED|95.0|-4.79|-2.44|||Linear mixed effect model|||||-2.44|-4.79|<0.001
71926606|NCT03522506|143373642|SUPERIORITY|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.16|||<|0.001|TWO_SIDED|95.0|-4.32|-2.01|||Linear mixed effect model|||||-2.01|-4.32|<0.001
71926607|NCT03522506|143373642|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.69||||0.003|TWO_SIDED|95.0|-2.78|-0.6|||Linear mixed effect model|||||-0.60|-2.78|0.003
71926608|NCT03522506|143373642|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-4.3|||<|0.001|TWO_SIDED|95.0|-5.39|-3.21|||Linear mixed effect model|||||-3.21|-5.39|<0.001
71926609|NCT03522506|143373642|SUPERIORITY|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.83|||<|0.001|TWO_SIDED|95.0|-4.91|-2.76|||Linear mixed effect model|||||-2.76|-4.91|<0.001
71926610|NCT03522506|143373642|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.71||||0.13|TWO_SIDED|95.0|-1.63|0.21|||Linear mixed effect model|||||0.21|-1.63|0.130
71926611|NCT03522506|143373642|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.32|||<|0.001|TWO_SIDED|95.0|-4.24|-2.4|||Linear mixed effect model|||||-2.40|-4.24|<0.001
71926612|NCT03522506|143373642|SUPERIORITY|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.71|||<|0.001|TWO_SIDED|95.0|-3.62|-1.8|||Linear mixed effect model|||||-1.80|-3.62|<0.001
71926613|NCT03522506|143373642|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26||||0.577|TWO_SIDED|95.0|-1.2|0.68|||Linear mixed effect model|||||0.68|-1.20|0.577
71689567|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|-0.24||||0.2166|TWO_SIDED|95.0|-0.62|0.14|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.14|-0.62|0.2166
71926614|NCT03522506|143373642|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.26|||<|0.001|TWO_SIDED|95.0|-3.2|-1.32|||Linear mixed effect model|||||-1.32|-3.20|<0.001
71689568|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.5262|TWO_SIDED|95.0|-0.52|0.27|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.27|-0.52|0.5262
71926615|NCT03522506|143373642|SUPERIORITY|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.65|||<|0.001|TWO_SIDED|95.0|-2.57|-0.72|||Linear mixed effect model|||||-0.72|-2.57|<0.001
71926616|NCT03522506|143373642|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.31||||0.475|TWO_SIDED|95.0|-0.55|1.16|||Linear mixed effect model|||||1.16|-0.55|0.475
71926617|NCT03522506|143373642|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.14||||0.753|TWO_SIDED|95.0|-0.99|0.72|||Linear mixed effect model|||||0.72|-0.99|0.753
71926618|NCT03522506|143373642|SUPERIORITY|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.99||||0.022|TWO_SIDED|95.0|-1.83|-0.15|||Linear mixed effect model|||||-0.15|-1.83|0.022
71926619|NCT03522506|143373643|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|22.94|||<|0.001|TWO_SIDED|95.0|16.58|29.3|||Linear mixed effect model|||||29.30|16.58|<0.001
71926620|NCT03522506|143373643|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|30.95|||<|0.001|TWO_SIDED|95.0|24.59|37.31|||Linear mixed effects model|||||37.31|24.59|<0.001
71926621|NCT03522506|143373643|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|26.5|||<|0.001|TWO_SIDED|95.0|20.24|32.75|||Linear mixed effect model|||||32.75|20.24|<0.001
71926622|NCT03522506|143373644|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|14.56|||<|0.001|TWO_SIDED|95.0|7.04|22.08|||Linear mixed effect model|||||22.08|7.04|<0.001
71926623|NCT03522506|143373644|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|32.21|||<|0.001|TWO_SIDED|95.0|24.68|39.73|||Linear mixed effect model|||||39.73|24.68|<0.001
71926624|NCT03522506|143373644|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|25.74|||<|0.001|TWO_SIDED|95.0|18.33|33.14|||Linear mixed effect model|||||33.14|18.33|<0.001
71926625|NCT03522506|143373645|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|9.6||||0.003|TWO_SIDED|95.0|3.35|15.85|||Linear mixed effect model|||||15.85|3.35|0.003
71689569|NCT04378569|142895500|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.7575|TWO_SIDED|95.0|-0.39|0.54|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Treatment group, pooled site group, and baseline IGA were independent variables, with multiple imputation of missing data|Week 12||0.54|-0.39|0.7575
71689570|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|1.73||||0.2662|TWO_SIDED|95.0|0.64|4.7|||Cochran-Mantel-Haenszel|Stratified|Stratified|Week 2||4.70|0.64|0.2662
71926626|NCT03522506|143373645|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|33.33|||<|0.001|TWO_SIDED|95.0|27.08|39.58|||Linear mixed effect model|||||39.58|27.08|<0.001
71926627|NCT03522506|143373645|SUPERIORITY|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.91|||<|0.001|TWO_SIDED|95.0|10.77|23.06|||Linear mixed effect model|||||23.06|10.77|<0.001
71926628|NCT03522506|143373646|SUPERIORITY|An analysis of variance (ANOVA) model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.16||||0.436|TWO_SIDED|95.0|-7.68|3.36|||ANOVA|||||3.36|-7.68|0.436
71926629|NCT03522506|143373646|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.29||||0.409|TWO_SIDED|95.0|-7.81|3.23|||ANOVA|||||3.23|-7.81|0.409
71926630|NCT03522506|143373646|SUPERIORITY|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.77|||<|0.001|TWO_SIDED|95.0|11.37|22.18|||ANOVA|||||22.18|11.37|<0.001
71926631|NCT03480243|143373647|OTHER||Cmax Estimate Ratio|1.9|||||TWO_SIDED|90.0|1.59|2.27|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.27|1.59|
71926632|NCT03480243|143373647|OTHER||Cmax Estimate Ratio|1.81|||||TWO_SIDED|90.0|1.51|2.16|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.16|1.51|
71926633|NCT03480243|143373648|OTHER||AUC Estimate Ratio|1.8|||||TWO_SIDED|90.0|1.5|2.17|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.17|1.50|
71926634|NCT03480243|143373648|OTHER||AUC Estimate Ratio|1.64|||||TWO_SIDED|90.0|1.36|1.97|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||1.97|1.36|
71926635|NCT03480243|143373649|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.77|2.55|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.55|1.77|
71926636|NCT03480243|143373649|OTHER||Cmax,ss Estimate Ratio|2.13|||||TWO_SIDED|90.0|1.78|2.56|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.56|1.78|
71926637|NCT03480243|143373650|OTHER||AUCtau Estimate Ratio|2.48|||||TWO_SIDED|90.0|2.02|3.03|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||3.03|2.02|
71926638|NCT03480243|143373650|OTHER||AUCtau Estimate Ratio|2.23|||||TWO_SIDED|90.0|1.82|2.73|||ANOVA|||The analysis of variance model included the fixed effects period (1, 2 or 3b) and participant as a random effect.||2.73|1.82|
71926639|NCT00761085|143373675|OTHER|No statistical comparisons||||||||||||||||"No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults"|No statistical comparisons|||
71926640|NCT00761085|143373676|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71926641|NCT01522755|143373679|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71926642|NCT01522755|143373680|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71926643|NCT01522755|143373681|OTHER|t-test|||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71926644|NCT04365387|143373683|OTHER||Cochran-Mantel-Haenszel|2.1|||||TWO_SIDED|90.0|-10.3|14.5|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using Cochran-Mantel-Haenszel (CMH).|||14.5|-10.3|
71926645|NCT04365387|143373684|OTHER||Cochran-Mantel-Haenszel|-4.6|||||TWO_SIDED|90.0|-14.9|5.7|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.7|-14.9|
71926646|NCT04365387|143373686|OTHER||Cochran-Mantel-Haenszel|1.4|||||TWO_SIDED|90.0|-3.2|5.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||5.9|-3.2|
71926647|NCT04365387|143373687|OTHER||Cochran-Mantel-Haenszel|13.3|||||TWO_SIDED|90.0|0.1|26.4|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH for non-Imputed values|||26.4|0.1|
71926648|NCT04365387|143373688|OTHER||Cochran-Mantel-Haenszel|1.3|||||TWO_SIDED|90.0|-9.3|11.9|||||Risk Difference (90% CI) were estimated using weighted average of stratum-specific proportion using CMH.|||11.9|-9.3|
71926649|NCT05770401|143373689|SUPERIORITY||Mean Difference (Final Values)|3.24|STANDARD_ERROR_OF_MEAN|1.227||0.014|TWO_SIDED|95.0|0.72|5.76|||ANCOVA|||The null hypothesis was there would be no significant difference in LCQ total score change from baseline to one-week post-treatment between groups.||5.76|.72|.014
71926650|NCT05770401|143373690|SUPERIORITY||Mean Difference (Final Values)|-16.1|STANDARD_ERROR_OF_MEAN|8.804||0.056|TWO_SIDED|95.0|-32.7|0.46|||ANCOVA|||The null hypothesis was there would be no significant difference in Cough Severity VAS Scores from baseline to one-week post-treatment between groups.||0.46|-32.7|.056
71926651|NCT05643573|143373696|SUPERIORITY||Cox Proportional Hazard|3.785|||<|0.0001|TWO_SIDED|95.0|2.457|5.833|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||5.833|2.457|<.0001
71926652|NCT05643573|143373696|SUPERIORITY||Fine-Gray model|3.79|||<|0.0001|TWO_SIDED|95.0|2.46|5.839|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||5.839|2.460|<.0001
71926653|NCT05643573|143373697|SUPERIORITY||Fine-Gray model|0.319|||<|0.0001|TWO_SIDED|95.0|0.185|0.552|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||0.552|0.185|<.0001
71926654|NCT05643573|143373697|SUPERIORITY||Fine-Gray model|0.316|||<|0.0001|TWO_SIDED|95.0|0.182|0.547|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||0.547|0.182|<.0001
71926655|NCT05643573|143373698|SUPERIORITY||Fine-Gray model|1.61||||0.0011|TWO_SIDED|95.0|1.207|2.149|||Log Rank|||Comparison of Asundexian 50 mg verus Apixaban||2.149|1.207|0.0011
71689571|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|1.54||||0.3798|TWO_SIDED|95.0|0.59|4.0|||Cochran-Mantel-Haenszel|||Week 2||4.00|0.59|0.3798
71926656|NCT05643573|143373698|SUPERIORITY||Fine-Gray model|1.599||||0.0013|TWO_SIDED|95.0|1.197|2.134|||Gray's test|||Comparison of Asundexian 50 mg verus Apixaban||2.134|1.197|0.0013
71926657|NCT04089566|143373732|SUPERIORITY|The Analysis of Covariance (ANCOVA) model used rank score as response, treatment as fixed effect and disease duration at screening, baseline Hammersmith Infant Neurological Examination (HINE) Section 2 (HINE 2), baseline CHOP INTEND total score as covariates.|Least square (LS) mean difference|26.06|STANDARD_ERROR_OF_MEAN|4.141|<|0.0001|TWO_SIDED|95.0|17.941|34.172|||ANCOVA|||||34.172|17.941|< 0.0001
71926658|NCT04089566|143373755|SUPERIORITY||Difference of percentages|58.0|||<|0.0001|TWO_SIDED|95.0|39.46|71.81|||Fisher Exact||Exact unconditional confidence interval|||71.81|39.46|<0.0001
71926659|NCT04089566|143373756|SUPERIORITY||LS mean difference|26.67|STANDARD_ERROR_OF_MEAN|4.009|<|0.0001|TWO_SIDED|95.0|18.812|34.526||ANCOVA model was used treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||34.526|18.812|<0.0001
71926660|NCT04089566|143373757|SUPERIORITY||LS geometric mean ratio|0.08|||<|0.0001||||||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||||<0.0001
71926661|NCT04089566|143373758|SUPERIORITY||LS mean difference|1.0|STANDARD_ERROR_OF_MEAN|5.251|=|0.8484|TWO_SIDED|95.0|-9.29|11.299||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||11.299|-9.29|=0.8484
71926662|NCT04089566|143373759|SUPERIORITY||LS mean difference|6.12|STANDARD_ERROR_OF_MEAN|4.497|=|0.1734|TWO_SIDED|95.0|-2.693|14.939||ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.|ANCOVA|||||14.939|-2.693|=0.1734
71926663|NCT04089566|143373760|SUPERIORITY||LS geometric mean ratio|0.51|||=|0.002|TWO_SIDED|95.0|0.33|0.78||ANCOVA model was used with treatment as a fixed effect and adjustment for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.|ANCOVA|||||0.78|0.33|=0.002
71926664|NCT04089566|143373803|SUPERIORITY||LS geometric mean ratio|0.86|||=|0.3785|TWO_SIDED|95.0|0.62|1.2||ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log CSF NF-L and baseline CHOP INTEND total score.|ANCOVA|||||1.2|0.62|=0.3785
71689572|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|3.18||||0.0611|TWO_SIDED|95.0|0.9|11.17|||Cochran-Mantel-Haenszel|||Week 2||11.17|0.90|0.0611
71689573|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|1.58||||0.3129|TWO_SIDED|95.0|0.64|3.93|||Cochran-Mantel-Haenszel|||Week 4||3.93|0.64|0.3129
71926665|NCT00056472|143373822|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28|||<|0.001||95.0|1.12|1.47|||Regression, Logistic|||Predicting remission rates of 40% in combination therapy and 20% in monotherapy subjects, 260 subjects randomized into the two treatment groups would provide \>80% power at a two-tailed alpha level of .05. Treatment efficacy was compared between groups based on intent-to-treat analyses for the longitudinal binary outcome of remission using mixed effects logistic regression with a random intercept that included treatment and time as fixed effects and a treatment by time interaction effect.||1.47|1.12|<.001
71926666|NCT00056472|143373823|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||The p-value is for the overall mean CGI-S score compared to baseline.|Mixed Models Analysis|This was a longitudinal analysis of CGI-S scores compared to baseline.||Intent-to-treat changes in global improvement from week to week compared to baseline (CGI-S) over the course of the trial using longitudinal mixed effects linear regression models. The null hypothesis is that there is no difference in overall change in CGI-S.||||.02
71926667|NCT00056472|143373824|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value is for the overall mean across all time points between each treatment group.|Mixed Models Analysis|||Intent-to-treat between group comparison using longitudinal mixed effects regression.||||<.001
71926668|NCT03677440|143373825|SUPERIORITY|||||||0.34|||||||ANOVA|||This involves a repeated-measures ANOVA testing a condition (i.e., treadmill walking exercise training vs. stretching-and-toning exercise training)-by-time (i.e., baseline, follow-up) interaction on Symbol Digit Modalities Test scores.||||.34
71926669|NCT03677440|143373826|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||||||.01
71926670|NCT03677440|143373827|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||||||.02
71926671|NCT03677440|143373828|SUPERIORITY|||||||0.63|||||||ANOVA|||||||.63
71926672|NCT03677440|143373829|SUPERIORITY||Partial eta-squared|0.067||||0.2|TWO_SIDED||||||ANOVA|||||||.20
71926673|NCT03677440|143373830|SUPERIORITY|||||||0.96|||||||ANOVA|||||||.96
71689574|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9586|TWO_SIDED|95.0|0.35|2.74|||Cochran-Mantel-Haenszel|||Week 4||2.74|0.35|0.9586
71926674|NCT03677440|143373831|SUPERIORITY|||||||0.55|||||||ANOVA|||||||.55
71926675|NCT03677440|143373832|SUPERIORITY||Partial eta-squared|0.087||||0.14|TWO_SIDED||||||ANOVA|||||||.14
71926676|NCT03677440|143373833|SUPERIORITY|||||||0.69|||||||ANOVA|||||||.69
71926677|NCT03677440|143373834|SUPERIORITY||Partial eta-squared|0.048||||0.28|TWO_SIDED||||||ANOVA|||||||.28
71926678|NCT01875731|143373844|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.09||||0.01|TWO_SIDED|95.0|1.57|16.8|||Chi-squared|||||16.8|1.57|0.01
71926679|NCT01875731|143373845|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.71|TWO_SIDED|95.0|0.1|4.09|||Chi-squared|||||4.09|0.1|0.71
71689575|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|3.65||||0.0643|TWO_SIDED|95.0|0.87|15.29|||Cochran-Mantel-Haenszel|||Week 4||15.29|0.87|0.0643
71926680|NCT01441882|143373858|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.0106|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (lymph node size).||||0.0106
71926681|NCT01441882|143373858|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.1986|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (Absolute Lymphocyte Count (ALC)).||||0.19860
71926682|NCT01441882|143373858|NON_INFERIORITY|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.5167|TWO_SIDED|95.0|||||t-test, 2 sided|Threshold for statistical significance is 0.05.||Percent change from baseline in responders compared to non-responders (spleen size).||||0.5167
71926683|NCT00437294|143373883|SUPERIORITY_OR_OTHER_LEGACY|||||||0.237||||||The 1-sided significance level was 0.20.|Log Rank|||||||0.237
71926684|NCT00437294|143373888|SUPERIORITY_OR_OTHER_LEGACY|||||||1||||||1-sided significance level was 0.20.|Fisher Exact|||||||1.00
71926685|NCT00437294|143373889|SUPERIORITY_OR_OTHER_LEGACY|||||||0.812|||||||Log Rank|||||||0.812
71926686|NCT00437294|143373890|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181|||||||Log Rank|||||||0.181
71926687|NCT00620776|143373918|SUPERIORITY_OR_OTHER|||||||0.17|||||||Mixed Models Analysis|||Mixed model analysis (differential slopes over time) comparing the 26 patients who received combined treatment with at least one CBT session to the 35 patients randomized to venlafaxine XR alone (and received at least one dose) on HAM-A total scores. Only available scores were used (no imputation for missing data). Because the HAM-A demonstrated a relatively rapid improvement early in treatment and then a leveling off, a shifted log-transformation of time of assessment was implemented.||||.17
71926688|NCT00620776|143373919|SUPERIORITY_OR_OTHER|||||||0.54|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.54
71926689|NCT00620776|143373920|SUPERIORITY_OR_OTHER|||||||0.86|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.86
71926690|NCT00620776|143373921|SUPERIORITY_OR_OTHER|||||||0.051|||||||ANCOVA|||Data collected at week 24 were analyzed using analysis of covariance (ANCOVA) with the baseline score as the covariate.||||.051
71926691|NCT00620776|143373922|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.06
71689576|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|2.41||||0.0932|TWO_SIDED|95.0|0.84|6.88|||Cochran-Mantel-Haenszel|||Week 8||6.88|0.84|0.0932
71926692|NCT00620776|143373923|SUPERIORITY_OR_OTHER|||||||0.95|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).||||.95
71926693|NCT00620776|143373924|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.17
71926694|NCT00620776|143373925|SUPERIORITY_OR_OTHER|||||||0.53|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.||||.53
71926695|NCT00620776|143373926|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA with baseline data as covariate.||||.23
71926696|NCT00620776|143373927|SUPERIORITY_OR_OTHER|||||||0.07|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA including baseline data as covariate.||||.07
71926697|NCT00620776|143373928|SUPERIORITY_OR_OTHER|||||||0.63|||||||Chi-squared|||||||.63
71926698|NCT00620776|143373929|SUPERIORITY_OR_OTHER|||||||0.52|||||||Chi-squared|||||||.52
71926699|NCT03992456|143373951|SUPERIORITY|||||||0.5126|||||||Un-Stratified Log-rank|||||||0.5126
71926700|NCT03992456|143373952|SUPERIORITY|||||||0.1512|||||||Un-Stratified Log-rank|||||||0.1512
71926701|NCT03992456|143373953|SUPERIORITY|||||||0.2506|||||||Chi-squared|||||||0.2506
71926702|NCT03992456|143373954|SUPERIORITY|||||||0.8865|||||||Chi-squared|||||||0.8865
71926703|NCT03992456|143373955|SUPERIORITY|||||||0.5455|||||||Fisher Exact|||||||0.5455
71926704|NCT04668066|143374023|OTHER||Least Square Mean Difference|5.6||||0.6343|TWO_SIDED|90.0|-21.4|32.6|||ANCOVA|||||32.6|-21.4|0.6343
71926705|NCT03414658|143374071|SUPERIORITY||Hazard Ratio (HR)|0.53||||0.025|TWO_SIDED|80.0|0.35|0.81|||Log Rank|||||0.81|0.35|0.025
71926706|NCT03414658|143374071|SUPERIORITY||Hazard Ratio (HR)|1.14||||0.32|TWO_SIDED|80.0|0.8|1.64|||Log Rank|||||1.64|0.8|0.32
71926707|NCT02388906|143374075|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.0003|TWO_SIDED|95.0|0.6|0.86|||Log Rank|Stratified log rank||||0.86|0.60|0.0003
71926708|NCT02388906|143374076|SUPERIORITY||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.03|0.69|1.11|||Log Rank||Stratified Cox proportional hazard model|||1.11|0.69|
71926709|NCT02388906|143374083|SUPERIORITY||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.63|0.9|||Log Rank|Stratified log rank||||0.90|0.63|
71926710|NCT04957979|143374121|SUPERIORITY||Mean Difference (Net)|-1.6||||0.19|TWO_SIDED|95.0|-4.1|0.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||0.1|-4.1|0.19
71926711|NCT04957979|143374121|SUPERIORITY||Mean Difference (Net)|-3.3||||0.005|TWO_SIDED|95.0|-5.6|-1.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Negative value represents smaller change in Medical/Social clinics as compared to Medical/Nursing.|Null hypothesis: Average change in composite care quality outcome is not different between patients receiving care in Medical/Nursing Model clinics and those receiving care in Medical/Social Model clinics.||-1.0|-5.6|0.005
71689577|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|1.42||||0.573|TWO_SIDED|95.0|0.44|4.59|||Cochran-Mantel-Haenszel|||Week 8||4.59|0.44|0.5730
71689578|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|4.96||||0.0389|TWO_SIDED|95.0|0.96|25.66|||Cochran-Mantel-Haenszel|||Week 8||25.66|0.96|0.0389
71689579|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|1.82||||0.2813|TWO_SIDED|95.0|0.6|5.53|||Cochran-Mantel-Haenszel|||Week 12||5.53|0.60|0.2813
71689580|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|0.72||||0.6841|TWO_SIDED|95.0|0.17|3.03|||Cochran-Mantel-Haenszel|||Week 12||3.03|0.17|0.6841
71926712|NCT04957979|143374122|SUPERIORITY||Incidence Rate Ratio|1.28||||0.02|TWO_SIDED|95.0|1.04|1.58||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.58|1.04|0.02
71926713|NCT04957979|143374122|SUPERIORITY||Incidence Rate Ratio|1.09||||0.45|TWO_SIDED|95.0|0.868|1.38||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.38|0.868|0.45
71926714|NCT04957979|143374123|SUPERIORITY||Incidence Rate Ratio|1.35||||0.01|TWO_SIDED|95.0|1.08|1.69||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.69|1.08|0.01
71926715|NCT04957979|143374123|SUPERIORITY||Incidence Rate Ratio|1.33||||0.08|TWO_SIDED|95.0|0.969|1.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher rates post-care coordination in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Poisson link function. Pre-care coordination measures were included as an independent variable when modeling post-measures to capture change related to care coordination initiation.||1.81|0.969|0.08
71926716|NCT04957979|143374124|SUPERIORITY||Odds Ratio (OR)|0.64||||0.0001|TWO_SIDED|95.0|0.51|0.81||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||0.81|0.51|0.0001
71926717|NCT04957979|143374124|SUPERIORITY||Odds Ratio (OR)|1.2||||0.32|TWO_SIDED|95.0|0.84|1.72||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.72|0.84|0.32
71926718|NCT04957979|143374125|SUPERIORITY||Odds Ratio (OR)|0.85||||0.14|TWO_SIDED|95.0|0.69|1.05||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.05|0.69|0.14
71926719|NCT04957979|143374125|SUPERIORITY||Odds Ratio (OR)|0.74||||0.12|TWO_SIDED|95.0|0.51|1.08||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Adjusted for patient demographics, comorbidities, clinic characteristics, and includes random effect for clustering within clinic.|Values \> 1.0 represents higher likelihood of positive rating in Medical/Social clinics as compared to Medical/Nursing.|Generalized Linear Mixed Models with Binomial link function.||1.08|0.51|0.12
71926720|NCT04957979|143374126|SUPERIORITY||Odds Ratio (OR)|1.086||||0.914|TWO_SIDED|95.0|0.243|4.861||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.861|0.243|0.914
71926721|NCT04957979|143374126|SUPERIORITY||Odds Ratio (OR)|1.009||||0.987|TWO_SIDED|95.0|0.327|3.114||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||3.114|0.327|0.987
71926722|NCT04957979|143374127|SUPERIORITY||Odds Ratio (OR)|1.257||||0.204|TWO_SIDED|95.0|0.883|1.79||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.79|0.883|0.204
71926723|NCT04957979|143374127|SUPERIORITY||Odds Ratio (OR)|0.399||||0.04|TWO_SIDED|95.0|0.166|0.958|||Mixed Models Analysis|||||0.958|0.166|0.04
71926724|NCT04957979|143374128|SUPERIORITY||Odds Ratio (OR)|1.257||||0.302|TWO_SIDED|95.0|0.814|1.939||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.939|0.814|0.302
71926725|NCT04957979|143374128|SUPERIORITY||Odds Ratio (OR)|0.84||||0.192|TWO_SIDED|95.0|0.647|1.092||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.092|0.647|0.192
71926726|NCT04957979|143374129|SUPERIORITY||Odds Ratio (OR)|0.438||||0.318|TWO_SIDED|95.0|0.086|2.22||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.22|0.086|0.318
71926727|NCT04957979|143374129|SUPERIORITY||Odds Ratio (OR)|1.793||||0.421|TWO_SIDED|95.0|0.433|7.426||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||7.426|0.433|0.421
71689581|NCT04378569|142895502|SUPERIORITY||Odds Ratio (OR)|2.13||||0.3113|TWO_SIDED|95.0|0.49|9.21|||Cochran-Mantel-Haenszel|||Week 12||9.21|0.49|0.3113
71926728|NCT04957979|143374130|SUPERIORITY||Odds Ratio (OR)|0.906||||0.632|TWO_SIDED|95.0|0.606|1.356||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.356|0.606|0.632
71926729|NCT04957979|143374130|SUPERIORITY||Odds Ratio (OR)|0.845||||0.492|TWO_SIDED|95.0|0.523|1.366||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.366|0.523|0.492
71926730|NCT04957979|143374131|SUPERIORITY||Odds Ratio (OR)|0.856||||0.405|TWO_SIDED|95.0|0.594|1.234||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.234|0.594|0.405
71926731|NCT04957979|143374131|SUPERIORITY||Odds Ratio (OR)|0.559||||0.004|TWO_SIDED|95.0|0.374|0.834|||Mixed Models Analysis|||||0.834|0.374|0.004
71926732|NCT04957979|143374132|SUPERIORITY||Odds Ratio (OR)|0.151||||0.071|TWO_SIDED|95.0|0.02|1.173||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.173|0.02|0.071
71689582|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.21||||0.2674|TWO_SIDED|95.0|0.46|10.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||10.67|0.46|0.2674
71926733|NCT04957979|143374132|SUPERIORITY||Mean Difference (Net)|0.023||||0.003|TWO_SIDED|95.0|0.002|0.268||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||0.268|0.002|0.003
71689583|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.78||||0.285|TWO_SIDED|95.0|0.44|17.54|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||17.54|0.44|0.2850
71689584|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.63||||0.3086|TWO_SIDED|95.0|0.42|16.52|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 2||16.52|0.42|0.3086
71689585|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|4.33||||0.1655|TWO_SIDED|95.0|0.46|40.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||40.83|0.46|0.1655
71926734|NCT04957979|143374133|SUPERIORITY||Odds Ratio (OR)|0.884||||0.557|TWO_SIDED|95.0|0.587|1.333||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.333|0.587|0.557
71926735|NCT04957979|143374133|SUPERIORITY||Mean Difference (Net)|0.624||||0.069|TWO_SIDED|95.0|0.376|1.037||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.037|0.376|0.069
71926736|NCT04957979|143374134|SUPERIORITY||Odds Ratio (OR)|0.539||||0.256|TWO_SIDED|95.0|0.185|1.565||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.565|0.185|0.256
71926737|NCT04957979|143374134|SUPERIORITY||Odds Ratio (OR)|1.117||||0.866|TWO_SIDED|95.0|0.308|4.047||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||4.047|0.308|0.866
71689586|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|1.41||||0.7154|TWO_SIDED|95.0|0.26|7.67|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||7.67|0.26|0.7154
71926738|NCT04957979|143374135|SUPERIORITY||Odds Ratio (OR)|0.797||||0.641|TWO_SIDED|95.0|0.307|2.069||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||2.069|0.307|0.641
71926739|NCT04957979|143374135|SUPERIORITY||Odds Ratio (OR)|0.569||||0.32|TWO_SIDED|95.0|0.187|1.729||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Mixed Models Analysis|Binomial link function. Estimation parameter is the interaction between Time (post vs pre) and Care Model (Medical/Social vs Medical Nursing).|Values \> 1.0 represents larger improvement pre to post-care coordination in likelihood of specific care quality outcome for patients in Medical/Social clinics as compared to those in Medical/Nursing.|||1.729|0.187|0.32
71926740|NCT04957979|143374136|SUPERIORITY||Risk Difference (RD)|9.3|||<|0.001|TWO_SIDED|95.0|5.6|13.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||13|5.6|<.001
71926741|NCT04957979|143374136|SUPERIORITY||Risk Difference (RD)|11.0||||0.002|TWO_SIDED|95.0|4.2|18.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||18|4.2|0.002
71926742|NCT04957979|143374137|SUPERIORITY||Risk Difference (RD)|6.0||||0.023|TWO_SIDED|95.0|0.86|11.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||11.0|0.86|0.023
71926743|NCT04957979|143374137|SUPERIORITY||Risk Difference (RD)|-3.7||||0.5|TWO_SIDED|95.0|-14.0|7.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher proportion of responders in Medical/Nursing clinics as compared to Medical/Social.|||7.0|-14.0|0.5
71926744|NCT04957979|143374138|SUPERIORITY||Mean Difference (Net)|0.13|||<|0.001|TWO_SIDED|95.0|0.06|0.19||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.19|0.06|<0.001
71926745|NCT04957979|143374138|SUPERIORITY||Mean Difference (Net)|0.19|||<|0.001|TWO_SIDED|95.0|0.06|0.32||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Positive values reflect higher/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||0.32|0.06|<0.001
71926746|NCT04957979|143374139|SUPERIORITY||Mean Difference (Net)|-0.11|||<|0.001|TWO_SIDED|95.0|-0.16|-0.06|||t-test, 2 sided|No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.06|-0.16|<0.001
71926747|NCT04957979|143374139|SUPERIORITY||Mean Difference (Net)|-0.11||||0.006|TWO_SIDED|95.0|-0.2|-0.03|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.03|-0.2|0.006
71926748|NCT04957979|143374140|SUPERIORITY||Risk Difference (RD)|-2.4||||0.059|TWO_SIDED|95.0|-4.9|0.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||0.00|-4.9|0.059
71926749|NCT04957979|143374140|SUPERIORITY||Risk Difference (RD)|-5.7||||0.014|TWO_SIDED|95.0|-10.0|-1.3||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.3|-10.0|0.014
71926750|NCT04957979|143374141|SUPERIORITY||Risk Difference (RD)|11.0|||<|0.001|TWO_SIDED|95.0|6.8|15.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared|||||15.0|6.8|<0.001
71926751|NCT04957979|143374141|SUPERIORITY||Risk Difference (RD)|12.0||||0.001|TWO_SIDED|95.0|4.7|20.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||20.0|4.7|0.001
71689587|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.0||||0.5371|TWO_SIDED|95.0|0.27|14.64|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 4||14.64|0.27|0.5371
71689588|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|5.0||||0.217|TWO_SIDED|95.0|0.43|57.83|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||57.83|0.43|0.2170
71689589|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.74||||0.3408|TWO_SIDED|95.0|0.41|18.22|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||18.22|0.41|0.3408
71689590|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.4||||0.327|TWO_SIDED|95.0|0.41|14.2|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade|Stratified by pooled site group and baseline IGA grade|Week 8||14.20|0.41|0.3270
71689591|NCT04378569|142895505|SUPERIORITY|||||||0.0719|||||||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||||0.0719
71689592|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|0.78||||0.8527|TWO_SIDED|95.0|0.07|8.43|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||8.43|0.07|0.8527
71926752|NCT04957979|143374142|SUPERIORITY||Mean Difference (Net)|-7.6|||<|0.001|TWO_SIDED|95.0|-10.0|-5.0||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5|-10|<.001
71926753|NCT04957979|143374142|SUPERIORITY||Mean Difference (Net)|-6.0||||0.007|TWO_SIDED|95.0|-10.0|-2.0|||t-test, 2 sided||Negative values reflect lower/better scores of responders in Medical/Nursing clinics as compared to Medical/Social.|||-2|-10|0.007
71926754|NCT04957979|143374143|SUPERIORITY||Risk Difference (RD)|-2.5||||0.046|TWO_SIDED|95.0|-4.8|-0.14||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.14|-4.8|0.046
71689593|NCT04378569|142895505|SUPERIORITY||Odds Ratio (OR)|2.2||||0.3545|TWO_SIDED|95.0|0.37|13.11|||Cochran-Mantel-Haenszel|Stratified by pooled site group and baseline IGA grade||Week 12||13.11|0.37|0.3545
71689594|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-4.4||||0.0725|TWO_SIDED|95.0|-9.2|0.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.4|-9.2|0.0725
71689595|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-5.8||||0.0183|TWO_SIDED|95.0|-10.7|-1.0|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||-1.0|-10.7|0.0183
71689596|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-1.7||||0.5701|TWO_SIDED|95.0|-7.7|4.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables||Week 2||4.3|-7.7|0.5701
71689597|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-4.0||||0.2116|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||2.3|-10.4|0.2116
71689598|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-5.1||||0.1235|TWO_SIDED|95.0|-11.5|1.4|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||1.4|-11.5|0.1235
71689599|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-1.9||||0.6334|TWO_SIDED|95.0|-9.7|5.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 4||5.9|-9.7|0.6334
71689600|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.1788|TWO_SIDED|95.0|-11.4|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||2.1|-11.4|0.1788
71689601|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-7.6||||0.0292|TWO_SIDED|95.0|-14.4|-0.8|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.8|-14.4|0.0292
71689602|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-8.8||||0.0371|TWO_SIDED|95.0|-17.1|-0.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 8||-0.5|-17.1|0.0371
71689603|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-3.9||||0.2971|TWO_SIDED|95.0|-11.3|3.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||3.5|-11.3|0.2971
71926755|NCT04957979|143374143|SUPERIORITY||Risk Difference (RD)|-4.5||||0.033|TWO_SIDED|95.0|-8.4|-0.52||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-0.52|-8.4|0.033
71926756|NCT04957979|143374144|SUPERIORITY||Risk Difference (RD)|-10.0|||<|0.001|TWO_SIDED|95.0|-13.0|-6.8||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-6.8|-13.0|<0.001
71926757|NCT04957979|143374144|SUPERIORITY||Risk Difference (RD)|-11.0|||<|0.001|TWO_SIDED|95.0|-17.0|-5.6||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-5.6|-17.0|<0.001
71926758|NCT04957979|143374145|SUPERIORITY||Risk Difference (RD)|-7.2|||<|0.001|TWO_SIDED|95.0|-10.0|-4.1||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-4.1|-10.0|<0.001
71926759|NCT04957979|143374145|SUPERIORITY||Risk Difference (RD)|-8.2||||0.002|TWO_SIDED|95.0|-13.0|-3.2||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social|||-3.2|-13.0|0.002
71926760|NCT04957979|143374146|SUPERIORITY||Risk Difference (RD)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||-1.4|-5.5|0.002
71926761|NCT04957979|143374146|SUPERIORITY||Risk Difference (RD)|-2.4||||0.3|TWO_SIDED|95.0|-6.1|1.4||No adjustments for multiple comparisons. Two-sided alpha of 0.05 specified a-priori|Chi-squared||Positive values reflect higher percentage of responders in Medical/Nursing clinics as compared to Medical/Social.|||1.4|-6.1|0.3
71926762|NCT02255422|143374147|SUPERIORITY||LS mean difference (net)|-0.015|STANDARD_ERROR_OF_MEAN|0.0446||0.7321|TWO_SIDED|95.0|-0.1051|0.0743||P-Value relates to difference in change in peak work from baseline relative to placebo for all doses pooled. Statistical significance was defined as p\<0.05|Mixed Models Analysis|Null hypothesis: wk 12 mean change from baseline (\[μ RTA 408\] - \[μ Placebo\]) in peak work = 0 w/kg. Positive change from baseline suggests improvement||Primary Objective: To evaluate the change in peak work during maximal exercise testing||0.0743|-0.1051|0.7321
71926763|NCT02255422|143374148|SUPERIORITY||LS mean difference (net)|-33.448|STANDARD_ERROR_OF_MEAN|11.6473||0.006|TWO_SIDED|95.0|-56.855|-10.042||P-value comparison is for difference in change in six minute walk distance from baseline within each dosage group relative to placebo. Statistical significance defined as p\<0.05.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 4||-10.042|-56.855|0.0060
71926764|NCT02255422|143374148|SUPERIORITY||LS mean difference (net)|-3.963|STANDARD_ERROR_OF_MEAN|11.53||0.7325|TWO_SIDED|95.0|-27.133|19.207||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 8||19.207|-27.133|0.7325
71926765|NCT02255422|143374148|SUPERIORITY||LS mean difference (net)|-18.594|STANDARD_ERROR_OF_MEAN|15.0004||0.221|TWO_SIDED|95.0|-48.739|11.55||Statistical significance was defined as p\<0.05. The p-value comparison is for the difference in change in 6MWD from baseline within each dosage group relative to placebo.|Mixed Models Analysis|The change from baseline in 6MWT was analyzed using the same MMRM model used for the primary efficacy endpoint. Analysis visits 0, 4, 8 and 12 used.||Secondary Objective: To evaluate the change in 6-minute walk test (6MWT) distance at Week 12||11.550|-48.739|0.2210
71926766|NCT04411641|143374149|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.693||||0.0026|TWO_SIDED|95.0|0.546|0.88||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation.Covariates were treatment group,age at screening (\>40,\<=40 years),geographic region (United States \[US\], non-US),baseline EDSS score \& baseline gadolinium (Gd)-enhancing T1 lesions (presence, absence).In this analysis, for participants who completed study with 3-month confirmation and continued to meet disability progression criteria throughout EOS, their 6-month CDP status was imputed via multiple imputation method.||0.880|0.546|0.0026
71926767|NCT04411641|143374150|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.757||||0.0134|TWO_SIDED|95.0|0.607|0.944||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.944|0.607|0.0134
71926768|NCT04411641|143374151|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Relative Risk|0.622||||0.011|TWO_SIDED|95.0|0.432|0.897||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Derived using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score, and baseline number of T2 lesions as covariates, and log transformed observation duration as the offset variable.||0.897|0.432|0.0110
71689604|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.015|TWO_SIDED|95.0|-17.2|-1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||-1.9|-17.2|0.0150
71689605|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-7.0||||0.1245|TWO_SIDED|95.0|-15.8|1.9|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 12||1.9|-15.8|0.1245
71689606|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-5.3||||0.1591|TWO_SIDED|95.0|-12.7|2.1|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||2.1|-12.7|0.1591
71689607|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-7.3||||0.06|TWO_SIDED|95.0|-14.8|0.3|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||0.3|-14.8|0.0600
71689608|NCT04378569|142895506|SUPERIORITY||Mean Difference (Final Values)|-3.3||||0.464|TWO_SIDED|95.0|-12.0|5.5|||ANCOVA|Treatment group, pooled site group, and baseline IGA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 13||5.5|-12.0|0.4640
71926769|NCT04411641|143374152|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.972||||0.8428|TWO_SIDED|95.0|0.735|1.286||Threshold for significance at 2-sided 0.05 level.|Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||1.286|0.735|0.8428
71926770|NCT04411641|143374153|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|0.767||||0.004|TWO_SIDED|95.0|0.64|0.919|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||0.919|0.640|0.0040
71926771|NCT04411641|143374154|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|Hazard Ratio (HR)|1.882||||0.0206|TWO_SIDED|95.0|1.102|3.214|||Regression, Cox|||Derived using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), baseline EDSS score and baseline Gd-enhancing T1 lesions (presence, absence).||3.214|1.102|0.0206
71926772|NCT04411641|143374155|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures are reported and continued when previous outcome measure was statistically significant at 2-sided 0.05. Primary and first 6 secondary endpoints are included in this procedure.|LS Mean Difference|0.082||||0.1646|TWO_SIDED|95.0|-0.034|0.197|||Mixed model repeated measures (MMRM)|||Covariates in the mixed-effect model with repeated measures were treatment group, age at screening (\>40, \<=40 years), geographic region (US, non-US), visit, treatment-by-visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.197|-0.034|0.1646
71926773|NCT03810417|143374166|SUPERIORITY||||||>|0.05|||||||Regression, Linear|||||||>0.05
71926774|NCT03810417|143374166|SUPERIORITY||||||<|0.05|||||||Regression, Logistic|||||||<0.05
71689609|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.066||||0.3184|TWO_SIDED|95.0|-0.196|0.064|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, and baseline IGA were independent variables|Week 2||0.064|-0.196|0.3184
71689610|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.013||||0.8514|TWO_SIDED|95.0|-0.149|0.123|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.123|-0.149|0.8514
71689611|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|0.091||||0.2603|TWO_SIDED|95.0|-0.068|0.249|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 2||0.249|-0.068|0.2603
71689612|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.171||||0.0273|TWO_SIDED|95.0|-0.323|-0.019|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.019|-0.323|0.0273
71689613|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0266|TWO_SIDED|95.0|-0.339|-0.021|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||-0.021|-0.339|0.0266
71689614|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.012||||0.9023|TWO_SIDED|95.0|-0.196|0.173|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 4||0.173|-0.196|0.9023
71689615|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.096||||0.3298|TWO_SIDED|95.0|-0.291|0.098|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.098|-0.291|0.3298
71926775|NCT01195662|143374178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.28|STANDARD_ERROR_OF_MEAN|1.1485||0.0002|TWO_SIDED|95.0|-6.54|-2.02||Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure used.|Longitudinal repeated measures|Data from all weeks during the double-blind treatment period were included.||Longitudinal repeated measures analysis using 'direct likelihood', with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, as well as continuous fixed covariates of baseline SBP value and baseline SBP value-by-week interaction. Unstructured matrix for within-subject error variance-covariance used. 80% power to detect a difference of 4 mmHg in mean change from baseline, 75% power to meet both co-primary endpoints with overall Type I error.||-2.02|-6.54|0.0002
71926776|NCT01195662|143374179|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.0773|<|0.0001|TWO_SIDED|95.0|-0.76|-0.46|||Longitudinal repeated measures|Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure was used.||A longitudinal repeated measures analysis used, with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, continuous fixed covariates of baseline HbA1c value and baseline HbA1c value-by-week interaction. Only data up to Week 12 included. All data used in the model even if participants discontinued prior to Week 12. A heirarchical closed testing procedure (sequential) was used and testing performed since first primary endpoint was significant.||-0.46|-0.76|<0.0001
71926777|NCT01195662|143374180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.45|STANDARD_ERROR_OF_MEAN|1.368||0.0012|TWO_SIDED|95.0|-7.14|-1.76||Endpoint tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate was used. By applying sequential testing procedure, the testing was performed since the prior endpoint was significant.||-1.76|-7.14|0.0012
71926778|NCT01195662|143374181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.69||0.1619|TWO_SIDED|95.0|-2.32|0.39||Endpoint tested following a sequential testing procedure at alpha=0.05.|Longitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline seated diastolic BP value and baseline seated diastolic BP value by week interaction.||0.39|-2.32|0.1619
71926779|NCT01195662|143374182|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|0.8635|||TWO_SIDED|95.0|-3.68|-0.29|||ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate. A hierarchical closed testing procedure was implemented to control the family-wise type I error rate related to the co-primary and secondary endpoints at the 2-sided 0.05 level. Statistical testing of this endpoint was not performed since the prior secondary endpoint was not statistically significant.||-0.29|-3.68|
71926780|NCT01195662|143374183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0858|||TWO_SIDED|95.0|-0.57|-0.23|||lLongitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline serum uric acid value and baseline seated serum uric acid value by week interaction. By applying sequential testing procedure at alpha=0.05, no testing was performed since the prior secondary endpoint was not significant.||-0.23|-0.57|
71689616|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.6205|TWO_SIDED|95.0|-0.251|0.15|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.150|-0.251|0.6205
71926781|NCT01215968|143374189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|2.19|||||TWO_SIDED|90.0|1.83|2.62|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 10 over Day 3.||||2.62|1.83|
71926782|NCT01215968|143374189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.94|||||TWO_SIDED|90.0|1.61|2.33|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 17 over Day 3.||||2.33|1.61|
71926783|NCT01215968|143374189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.91|||||TWO_SIDED|90.0|1.59|2.29|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 24 over Day 3.||||2.29|1.59|
71926784|NCT01215968|143374189|SUPERIORITY_OR_OTHER||Ratio of Geometric LS Mean|1.84|||||TWO_SIDED|90.0|1.52|2.22|||Mixed Linear effects model analyses|Ratio is the Geometric LS Means of Day 31 over Day 3.||||2.22|1.52|
71926785|NCT03222570|143374194|SUPERIORITY||Estimated mean difference|-0.88||||0.76|TWO_SIDED|95.0|-6.56|4.7|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||4.7|-6.56|0.76
71926786|NCT03222570|143374195|SUPERIORITY||Estimated mean difference|-2.52||||0.32|TWO_SIDED|95.0|-7.42|2.3|||Regression, Linear||Mean difference estimated from fitting a linear regression model adjusting for baseline value of the measure.|||2.3|-7.42|0.32
71926787|NCT05182840|143374232|OTHER||Mean Difference (Net)|-0.168||||0.0499|TWO_SIDED|95.0|-0.337|0.0|||MMRM||"Least Squares Mean of 3 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.000|-0.337|0.0499
71926788|NCT05182840|143374232|OTHER||Mean Difference (Net)|-0.486|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.313|||MMRM||"Least Squares Mean of 10 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.313|-0.660|<.0001
71926789|NCT05182840|143374232|OTHER||Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.596|-0.246|||MMRM||"Least Squares Mean of 20 mg BI 690517 - Least Squares Mean of Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.246|-0.596|<.0001
71926790|NCT05182840|143374232|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod Emax model fit|Emax model fit assumption: 80% of the maximum effect is achieved at 10 mg.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
71926791|NCT05182840|143374232|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0||||||P-value was rounded to four decimal places.|MCPMod linear model fit|Linear model fit assumption: No assumption is needed.||"A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod).~MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient."||||0.0000
71926792|NCT05182840|143374232|OTHER|Null hypothesis: The dose-response curve is flat across the 3 BI 690517 doses and the placebo.||||||0.0003|||||||MCPMod exponential model fit|Exponential model fit assumption: 15% of the maximum effect is achieved at 10 mg.||A flat vs. non-flat dose-response relationship across the 3 doses of BI 690517 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod). MMRM estimates were used as input for the MCP-Mod. MMRM included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||||0.0003
71926793|NCT05182840|143374233|OTHER||Median Difference (Net)|-15.5|||||TWO_SIDED|95.0|-28.6|0.0|||||"Median of 3 mg BI 690517 - Median of Placebo to BI 690517."|||-0.0|-28.6|
71926794|NCT05182840|143374233|OTHER||Median Difference (Net)|-38.5|||||TWO_SIDED|95.0|-48.3|-26.8|||||"Median of 10 mg BI 690517 - Median of Placebo to BI 690517."|||-26.8|-48.3|
71926795|NCT05182840|143374233|OTHER||Median Difference (Net)|-34.3|||||TWO_SIDED|95.0|-44.9|-21.8|||||"Median of 20 mg BI 690517 - Median of Placebo to BI 690517."|||-21.8|-44.9|
71926796|NCT05182840|143374234|OTHER||Mean Difference (Net)|-0.227||||0.0867|TWO_SIDED|95.0|-0.488|0.033|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.033|-0.488|0.0867
71926797|NCT05182840|143374234|OTHER||Mean Difference (Net)|-0.469||||0.0007|TWO_SIDED|95.0|-0.737|-0.201|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.201|-0.737|0.0007
71926798|NCT05182840|143374234|OTHER||Mean Difference (Net)|-0.429||||0.0027|TWO_SIDED|95.0|-0.707|-0.151|||MMRM||"Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - Least Squares Mean of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.151|-0.707|0.0027
71926799|NCT05182840|143374235|OTHER||Median Difference (Net)|-20.3|||||TWO_SIDED|95.0|-38.6|3.4|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||3.4|-38.6|
71926800|NCT05182840|143374235|OTHER||Median Difference (Net)|-37.4|||||TWO_SIDED|95.0|-52.2|-18.2|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517"|||-18.2|-52.2|
71926801|NCT05182840|143374235|OTHER||Median Difference (Net)|-34.9|||||TWO_SIDED|95.0|-50.7|-14.0|||||"Median of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 6905177 - median of Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|||-14.0|-50.7|
71926802|NCT05182840|143374236|OTHER||Mean Difference (Net)|-0.098||||0.3737|TWO_SIDED|95.0|-0.316|0.119|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||0.119|-0.316|0.3737
71926803|NCT05182840|143374236|OTHER||Mean Difference (Net)|-0.502|||<|0.0001|TWO_SIDED|95.0|-0.73|-0.275|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.275|-0.730|<.0001
71926804|NCT05182840|143374236|OTHER||Mean Difference (Net)|-0.404||||0.0004|TWO_SIDED|95.0|-0.625|-0.184|||MMRM||"Least Squares Mean of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - Least Squares Mean of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|The difference of adjusted means and 95 % confidence interval were estimated by restricted maximum likelihood-based mixed models for repeated measures ((REML)-based MMRM) which included the fixed effects of treatment at each visit, baseline (continuous) at each visit, and baseline, visit, treatment, background medication (empagliflozin or placebo matching empagliflozin) and randomisation stratum as main effects, as well as random effects of patient.||-0.184|-0.625|0.0004
71926805|NCT05182840|143374237|OTHER||Median Difference (Net)|-9.4|||||TWO_SIDED|95.0|-27.1|12.7|||||"Median of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||12.7|-27.1|
71689617|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.018||||0.8817|TWO_SIDED|95.0|-0.253|0.217|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 8||0.217|-0.253|0.8817
71926806|NCT05182840|143374237|OTHER||Median Difference (Net)|-39.5|||||TWO_SIDED|95.0|-51.8|-24.0|||||"Median of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-24.0|-51.8|
71926807|NCT05182840|143374237|OTHER||Median Difference (Net)|-33.2|||||TWO_SIDED|95.0|-46.5|-16.8|||||"Median of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 - median of Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|||-16.8|-46.5|
71926808|NCT05182840|143374238|OTHER||Odds Ratio (OR)|2.08||||0.0136|TWO_SIDED|95.0|1.16|3.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.72|1.16|0.0136
71926809|NCT05182840|143374238|OTHER||Odds Ratio (OR)|7.02||||0|TWO_SIDED|95.0|3.94|12.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||12.49|3.94|0.0000
71926810|NCT05182840|143374238|OTHER||Odds Ratio (OR)|5.48||||0|TWO_SIDED|95.0|3.09|9.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.71|3.09|0.0000
71926811|NCT05182840|143374239|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
71926812|NCT05182840|143374239|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
71926813|NCT05182840|143374239|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
71926814|NCT05182840|143374240|OTHER||Odds Ratio (OR)|1.8||||0.0348|TWO_SIDED|95.0|1.04|3.09||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.09|1.04|0.0348
71926815|NCT05182840|143374240|OTHER||Odds Ratio (OR)|4.12||||0|TWO_SIDED|95.0|2.4|7.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.08|2.40|0.0000
71926816|NCT05182840|143374240|OTHER||Odds Ratio (OR)|5.02||||0|TWO_SIDED|95.0|2.91|8.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.67|2.91|0.0000
71689618|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.1837|TWO_SIDED|95.0|-0.302|0.058|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.058|-0.302|0.1837
71926817|NCT05182840|143374241|OTHER||Odds Ratio (OR)|2.15||||0.0111|TWO_SIDED|95.0|1.19|3.88||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.88|1.19|0.0111
71926818|NCT05182840|143374241|OTHER||Odds Ratio (OR)|6.33||||0|TWO_SIDED|95.0|3.49|11.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.49|3.49|0.0000
71926819|NCT05182840|143374241|OTHER||Odds Ratio (OR)|5.21||||0|TWO_SIDED|95.0|2.88|9.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.44|2.88|0.0000
71926820|NCT05182840|143374242|OTHER||Odds Ratio (OR)|2.44||||0.0419|TWO_SIDED|95.0|1.03|5.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.74|1.03|0.0419
71926821|NCT05182840|143374242|OTHER||Odds Ratio (OR)|6.09||||0|TWO_SIDED|95.0|2.64|14.08||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.08|2.64|0.0000
71926822|NCT05182840|143374242|OTHER||Odds Ratio (OR)|6.13||||0|TWO_SIDED|95.0|2.64|14.25||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||14.25|2.64|0.0000
71926823|NCT05182840|143374243|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
71926824|NCT05182840|143374243|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
71926825|NCT05182840|143374243|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
71689619|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|-0.102||||0.2896|TWO_SIDED|95.0|-0.293|0.088|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|||0.088|-0.293|0.2896
71926826|NCT05182840|143374244|OTHER||Odds Ratio (OR)|2.03||||0.0767|TWO_SIDED|95.0|0.93|4.42||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.42|0.93|0.0767
71926827|NCT05182840|143374244|OTHER||Odds Ratio (OR)|4.11||||0.0003|TWO_SIDED|95.0|1.89|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.89|0.0003
71689620|NCT04378569|142895507|SUPERIORITY||Mean Difference (Final Values)|0.031||||0.919|TWO_SIDED|95.0|-0.205|0.227|||ANCOVA|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Treatment group, pooled site group, baseline IGA grade, and baseline % BSA were independent variables|Week 12||0.227|-0.205|0.9190
71689621|NCT04560868|142895512|EQUIVALENCE|The point null hypothesis was a difference in expected number of log ins of exactly 0.|Mean Difference (Final Values)|12.73|||<|0.01|TWO_SIDED|95.0|6.41|19.05|||Regression, Linear||mean difference=experimental-control|Based on a priori power calculations we had 80% power to detect an average increase of 3.8 log ins in the experimental relative to the control arm.||19.05|6.41|<0.01
71689622|NCT04560868|142895513|EQUIVALENCE|The null hypothesis was a point null of relative risk equal to exactly 1.|Risk Ratio (RR)|1.01||||0.98|TWO_SIDED|95.0|0.55|1.85|||Regression, Poisson||relative risk=experimental/control|Based on a priori power calculations, we had 80% power to detect a 33% - 35% increase in the proportion of experimental participants who successfully quit smoking for at least 24 hours relative to controls.||1.85|0.55|0.98
71926828|NCT05182840|143374244|OTHER||Odds Ratio (OR)|4.69||||0.0001|TWO_SIDED|95.0|2.15|10.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.24|2.15|0.0001
71926829|NCT05182840|143374245|OTHER||Odds Ratio (OR)|2.88||||0.0195|TWO_SIDED|95.0|1.19|7.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.02|1.19|0.0195
71926830|NCT05182840|143374245|OTHER||Odds Ratio (OR)|6.38||||0|TWO_SIDED|95.0|2.65|15.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.35|2.65|0.0000
71926831|NCT05182840|143374245|OTHER||Odds Ratio (OR)|6.39||||0.0001|TWO_SIDED|95.0|2.6|15.67||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.67|2.60|0.0001
71926832|NCT05182840|143374246|OTHER||Odds Ratio (OR)|1.82||||0.1398|TWO_SIDED|95.0|0.82|4.04||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.04|0.82|0.1398
71926833|NCT05182840|143374246|OTHER||Odds Ratio (OR)|8.42||||0|TWO_SIDED|95.0|3.73|19.02||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||19.02|3.73|0.0000
71926834|NCT05182840|143374246|OTHER|P-value was rounded to four decimal places.|Odds Ratio (OR)|4.98||||0.0001|TWO_SIDED|95.0|2.28|10.9|||Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||10.90|2.28|0.0001
71926835|NCT05182840|143374247|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
71689623|NCT04560868|142895514|EQUIVALENCE|The null hypothesis was a point null of exactly 0 risk difference between arms.|Risk Difference (RD)|0.08||||0.35|TWO_SIDED|95.0|-0.08|0.24|||Regression, Linear||Risk difference = experimental - control.|Based on a priori power calculations, we had 80% power to detect a 28% - 33% increase in 7-day smoking abstinence in the experimental arm relative to the control arm at 3 months.||0.24|-0.08|0.35
71689624|NCT04560868|142895515|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.26||||0.4|TWO_SIDED|95.0|-0.35|0.87|||Regression, Linear||mean difference=experimental-control|||0.87|-0.35|0.40
71689625|NCT04560868|142895516|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|-0.04||||0.9|TWO_SIDED|95.0|-0.68|0.6|||Regression, Linear||mean difference=experimental-control|||0.60|-0.68|0.90
71689626|NCT04560868|142895517|EQUIVALENCE|The tested hypothesis was a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.4||||0.39|TWO_SIDED|95.0|-0.5|1.4|||Regression, Linear||mean difference=experimental-control|||1.4|-0.5|0.39
71689627|NCT04560868|142895518|EQUIVALENCE|The tested hypothesis was for a point null of 0 difference in expected average helpfulness score between arms.|Mean Difference (Final Values)|0.6||||0.11|TWO_SIDED|95.0|-0.1|1.3|||Regression, Linear||mean difference=experimental-control|||1.3|-0.1|0.11
71689628|NCT04560868|142895520|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected number of badges earned in each arm by 3 months post-baseline.|Mean Difference (Final Values)|4.2|||<|0.01|TWO_SIDED|95.0|1.72|6.65|||Regression, Linear||mean difference=experimental-control|||6.65|1.72|<0.01
71926836|NCT05182840|143374247|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
71926837|NCT05182840|143374247|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
71926838|NCT05182840|143374248|OTHER||Odds Ratio (OR)|1.62||||0.214|TWO_SIDED|95.0|0.76|3.46||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.46|0.76|0.2140
71926839|NCT05182840|143374248|OTHER||Odds Ratio (OR)|4.13||||0.0003|TWO_SIDED|95.0|1.93|8.85||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.85|1.93|0.0003
71926840|NCT05182840|143374248|OTHER||Odds Ratio (OR)|5.43||||0|TWO_SIDED|95.0|2.52|11.71||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.71|2.52|0.0000
71926841|NCT05182840|143374249|OTHER||Odds Ratio (OR)|1.71||||0.1884|TWO_SIDED|95.0|0.77|3.79||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.79|0.77|0.1884
71926842|NCT05182840|143374249|OTHER||Odds Ratio (OR)|6.8||||0|TWO_SIDED|95.0|2.94|15.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||15.72|2.94|0.0000
71689629|NCT04560868|142895521|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected score between arms.|Mean Difference (Final Values)|0.08||||0.96|TWO_SIDED|95.0|-1.02|1.18|||Regression, Linear||mean difference=experimental-control|||1.18|-1.02|0.96
71689630|NCT04560868|142895522|EQUIVALENCE|The null hypothesis was a point null hypothesis of exactly 0 difference in expected score between the arms.|Mean Difference (Final Values)|-0.44||||0.31|TWO_SIDED|95.0|-1.55|0.66|||Regression, Linear||mean difference=experimental-control|||0.66|-1.55|0.31
71689631|NCT04560868|142895526|EQUIVALENCE|The point null hypothesis was of the exact same proportion of control and experimental subjects requesting NRT.|Risk Ratio (RR)|3.9||||0.06|TWO_SIDED|95.0|0.9|16.9|||Regression, Poisson||RR=experimental/control|||16.9|0.9|0.06
71689632|NCT04560868|142895527|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in probability of the outcome between arms.|Risk Ratio (RR)|1.01||||0.99|TWO_SIDED|95.0|0.38|2.65|||Regression, Poisson||risk ratio=experimental/control|||2.65|0.38|0.99
71689633|NCT04560868|142895528|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change from baseline in number of cigarettes smoked per day between arms.|Mean Difference (Net)|1.39||||0.3|TWO_SIDED|95.0|-1.21|3.99|||Regression, Linear||treatment difference=experimental-control, where the outcome for each individual is (one month)-baseline.|||3.99|-1.21|0.30
71926843|NCT05182840|143374249|OTHER||Odds Ratio (OR)|4.46||||0.0003|TWO_SIDED|95.0|2.0|9.94||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.94|2.00|0.0003
71926844|NCT05182840|143374250|OTHER||Odds Ratio (OR)|2.18||||0.0024|TWO_SIDED|95.0|1.32|3.61||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.61|1.32|0.0024
71926845|NCT05182840|143374250|OTHER||Odds Ratio (OR)|4.05||||0|TWO_SIDED|95.0|2.39|6.86||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.86|2.39|0.0000
71926846|NCT05182840|143374250|OTHER||Odds Ratio (OR)|3.87||||0|TWO_SIDED|95.0|2.29|6.55||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.55|2.29|0.0000
71926847|NCT05182840|143374251|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
71926848|NCT05182840|143374251|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
71926849|NCT05182840|143374251|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
71926850|NCT05182840|143374252|OTHER||Odds Ratio (OR)|1.67||||0.0418|TWO_SIDED|95.0|1.02|2.74||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.74|1.02|0.0418
71926851|NCT05182840|143374252|OTHER||Odds Ratio (OR)|3.91||||0|TWO_SIDED|95.0|2.3|6.65||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.65|2.30|0.0000
71926852|NCT05182840|143374252|OTHER||Odds Ratio (OR)|3.58||||0|TWO_SIDED|95.0|2.11|6.05||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.05|2.11|0.0000
71926853|NCT05182840|143374253|OTHER||Odds Ratio (OR)|2.26||||0.0019|TWO_SIDED|95.0|1.35|3.77||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 3 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||3.77|1.35|0.0019
71926854|NCT05182840|143374253|OTHER||Odds Ratio (OR)|3.81||||0|TWO_SIDED|95.0|2.2|6.59||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 10 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.59|2.20|0.0000
71926855|NCT05182840|143374253|OTHER||Odds Ratio (OR)|3.67||||0|TWO_SIDED|95.0|2.12|6.35||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of 20 mg BI 690517 vs. Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.35|2.12|0.0000
71926856|NCT05182840|143374254|OTHER||Odds Ratio (OR)|2.2||||0.0285|TWO_SIDED|95.0|1.09|4.45||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.45|1.09|0.0285
71926857|NCT05182840|143374254|OTHER||Odds Ratio (OR)|2.9||||0.0038|TWO_SIDED|95.0|1.41|5.96||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.96|1.41|0.0038
71926858|NCT05182840|143374254|OTHER||Odds Ratio (OR)|4.15||||0.0002|TWO_SIDED|95.0|1.97|8.72||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.72|1.97|0.0002
71926859|NCT05182840|143374255|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
71926860|NCT05182840|143374255|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
71926861|NCT05182840|143374255|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
71926862|NCT05182840|143374256|OTHER||Odds Ratio (OR)|1.34||||0.4092|TWO_SIDED|95.0|0.67|2.69||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||2.69|0.67|0.4092
71926863|NCT05182840|143374256|OTHER||Odds Ratio (OR)|3.66||||0.0005|TWO_SIDED|95.0|1.77|7.58||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.58|1.77|0.0005
71926864|NCT05182840|143374256|OTHER||Odds Ratio (OR)|4.04||||0.0002|TWO_SIDED|95.0|1.92|8.49||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.49|1.92|0.0002
71926865|NCT05182840|143374257|OTHER||Odds Ratio (OR)|2.16||||0.0348|TWO_SIDED|95.0|1.06|4.43||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.43|1.06|0.0348
71926866|NCT05182840|143374257|OTHER||Odds Ratio (OR)|6.08||||0|TWO_SIDED|95.0|2.73|13.57||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||13.57|2.73|0.0000
71926867|NCT05182840|143374257|OTHER||Odds Ratio (OR)|3.58||||0.0007|TWO_SIDED|95.0|1.71|7.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.52|1.71|0.0007
71926868|NCT05182840|143374258|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
71926869|NCT05182840|143374258|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
71926870|NCT05182840|143374258|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
71926871|NCT05182840|143374259|OTHER||Odds Ratio (OR)|2.17||||0.0342|TWO_SIDED|95.0|1.06|4.44||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.44|1.06|0.0342
71926872|NCT05182840|143374259|OTHER||Odds Ratio (OR)|4.23||||0.0003|TWO_SIDED|95.0|1.93|9.24||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||9.24|1.93|0.0003
71926873|NCT05182840|143374259|OTHER||Odds Ratio (OR)|3.19||||0.0023|TWO_SIDED|95.0|1.52|6.73||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.73|1.52|0.0023
71926874|NCT05182840|143374260|OTHER||Odds Ratio (OR)|2.56||||0.0116|TWO_SIDED|95.0|1.23|5.31||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||5.31|1.23|0.0116
71926875|NCT05182840|143374260|OTHER||Odds Ratio (OR)|3.08||||0.0032|TWO_SIDED|95.0|1.46|6.52||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||6.52|1.46|0.0032
71926876|NCT05182840|143374260|OTHER||Odds Ratio (OR)|4.07||||0.0004|TWO_SIDED|95.0|1.86|8.91||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517 vs. Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||8.91|1.86|0.0004
71689634|NCT04560868|142895529|EQUIVALENCE|The null hypothesis was a point null of exactly 0 difference in expected change in daily cigarette usage between arms.|Mean Difference (Net)|1.5||||0.47|TWO_SIDED|95.0|-2.51|5.5|||Regression, Linear||treatment effect=experimental-control, where the outcome for each individual is (three month)-baseline.|||5.5|-2.51|0.47
71926877|NCT05182840|143374261|OTHER||Odds Ratio (OR)|2.01||||0.0578|TWO_SIDED|95.0|0.98|4.14||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 3 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||4.14|0.98|0.0578
71926878|NCT05182840|143374261|OTHER||Odds Ratio (OR)|5.12||||0.0001|TWO_SIDED|95.0|2.23|11.78||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 10 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||11.78|2.23|0.0001
71926879|NCT05182840|143374261|OTHER||Odds Ratio (OR)|3.32||||0.0022|TWO_SIDED|95.0|1.54|7.16||P-value was rounded to four decimal places.|Regression, Logistic||"Odds ratio of Treatment period: 10 mg empagliflozin + 20 mg BI 690517 vs. Treatment period: 10 mg empagliflozin + Placebo to BI 690517."|"The odds ratio, 95% confidence interval, and p-value were calculated based on logistic regression of binary outcome adjusting for treatment, and stratification factors as covariates.~Randomisation stratification was used, which is based on estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR) levels at screening."||7.16|1.54|0.0022
71926880|NCT00863265|143374264|EQUIVALENCE||Mean Difference (Final Values)|289.0||||0.01|TWO_SIDED||||||ANOVA||The estimation parameter is the difference between the placebo group and the ezetimibe group.|Phytosterol Diet compared to Ezetimibe||||0.01
71689635|NCT04560868|142895530|EQUIVALENCE|The null hypothesis was risk difference of exactly 0.|Risk Difference (RD)|0.04||||0.3|TWO_SIDED|95.0|-0.03|0.11|||Regression, Linear||risk difference=experimental-control|||0.11|-0.03|0.30
71926881|NCT00863265|143374264|EQUIVALENCE|The hypothesis is that groups are equal.|Mean Difference (Final Values)|457.0|||<|0.01|TWO_SIDED||||||ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
71689636|NCT01724177|142895557|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:~H0: ORR ≤ 5% versus H1: ORR \> 5%"|Exact Test|||||||<0.0001
71926882|NCT00863265|143374264|EQUIVALENCE|The hypothesis is that groups are equal|Mean Difference (Final Values)|168.0|||<|0.01|TWO_SIDED||||||ANOVA|||Ezetimibe vs. Ezetimibe Plus Phytosterols||||<0.01
71926883|NCT00863265|143374265|EQUIVALENCE|Not applicable in this study.|Mean Difference (Final Values)|22.8|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal||||<0.01
71926884|NCT00863265|143374265|EQUIVALENCE||Mean Difference (Final Values)|36.4|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols||||<0.01
71926885|NCT00863265|143374265|EQUIVALENCE||Mean Difference (Final Values)|13.6|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.01
71926886|NCT00863265|143374266|EQUIVALENCE||Mean Difference (Final Values)|21.0|||<|0.01|TWO_SIDED||||||ANOVA|||The hypothesis is that groups are equal.||||<0.01
71926887|NCT00863265|143374266|EQUIVALENCE||Mean Difference (Final Values)|28.0|||<|0.01|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that all groups are equal||||<0.01
71926888|NCT00863265|143374266|EQUIVALENCE||Mean Difference (Final Values)|7.0|||<|0.05|TWO_SIDED|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.||||<0.05
71926889|NCT02268214|143374267|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.0697|<|0.0001|TWO_SIDED|95.0|-0.56|-0.28|||RMM|Repeated Measures Model||||-0.28|-0.56|<0.0001
71926890|NCT02268214|143374267|SUPERIORITY||Median Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.0696|<|0.0001|TWO_SIDED|95.0|-0.58|-0.31|||RMM|Repeated Measures Model||||-0.31|-0.58|<0.0001
71926891|NCT02268214|143374268|SUPERIORITY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|1.9555|<|0.0001|TWO_SIDED|95.0|-12.56|-4.88|||RMM|Repeated Measures Model||||-4.88|-12.56|<0.0001
71926892|NCT02268214|143374268|SUPERIORITY||Mean Difference (Final Values)|-13.17|STANDARD_ERROR_OF_MEAN|1.8643|<|0.0001|TWO_SIDED|95.0|-16.75|-9.43|||RMM|Repeated Measures Model||||-9.43|-16.75|<0.0001
71926893|NCT02268214|143374269|SUPERIORITY||Mean Difference (Final Values)|-3.05|STANDARD_ERROR_OF_MEAN|0.3251|<|0.0001|TWO_SIDED|95.0|-3.68|-2.41|||RMM|Repeated Measures Model||||-2.41|-3.68|<0.0001
71926894|NCT02268214|143374269|SUPERIORITY||Mean Difference (Final Values)|-3.72|STANDARD_ERROR_OF_MEAN|0.3213|<|0.0001|TWO_SIDED|95.0|-4.34|-3.08|||RMM|Repeated Measures Model||||-3.08|-4.34|<0.0001
71926895|NCT02268214|143374270|SUPERIORITY||Mean Difference (Final Values)|-15.34|STANDARD_ERROR_OF_MEAN|2.4859|<|0.0001|TWO_SIDED|95.0|-20.22|-10.46|||RMM|Repeated Measures Model||||-10.46|-20.22|<0.0001
71926896|NCT02268214|143374270|SUPERIORITY||Mean Difference (Final Values)|-18.03|STANDARD_ERROR_OF_MEAN|2.505|<|0.0001|TWO_SIDED|95.0|-22.95|-13.11|||RMM|Repeated Measures Model||||-13.11|-22.95|<0.0001
71926897|NCT02268214|143374271|SUPERIORITY||Mean Difference (Final Values)|-17.3|STANDARD_ERROR_OF_MEAN|2.6273|<|0.0001|TWO_SIDED|95.0|-22.46|-12.14|||RMM|Repeated Measures Model||||-12.14|-22.46|<0.0001
71926898|NCT02268214|143374271|SUPERIORITY||Mean Difference (Final Values)|-18.93|STANDARD_ERROR_OF_MEAN|2.6482|<|0.0001|TWO_SIDED|95.0|-24.13|-13.73|||RMM|Repeated Measures Model||||-13.73|-24.13|<0.0001
71926899|NCT02268214|143374272|SUPERIORITY||Mean Difference (Final Values)|9.11|STANDARD_ERROR_OF_MEAN|1.1611|<|0.0001|TWO_SIDED|95.0|6.83|11.39|||RMM|Repeated Measures Model||||11.39|6.83|<0.0001
71926900|NCT02268214|143374272|SUPERIORITY||Mean Difference (Final Values)|10.65|STANDARD_ERROR_OF_MEAN|1.1689|<|0.0001|TWO_SIDED|95.0|8.35|12.94|||RMM|Repeated Measures Model||||12.94|8.35|<0.0001
71926901|NCT02268214|143374273|SUPERIORITY||Odds Ratio (OR)|3.09|STANDARD_ERROR_OF_MEAN|0.198|<|0.0001|TWO_SIDED|95.0|2.1|4.56|||Regression, Logistic|||||4.56|2.10|<0.0001
71926902|NCT02268214|143374273|SUPERIORITY||Odds Ratio (OR)|3.29|STANDARD_ERROR_OF_MEAN|0.1979|<|0.0001|TWO_SIDED|95.0|2.23|4.85|||Regression, Logistic|||||4.85|2.23|<0.0001
71926903|NCT04342390|143374275|SUPERIORITY|||||||0.363|||||||ANCOVA|||||||0.363
71926904|NCT04342390|143374276|SUPERIORITY|||||||0.633|||||||ANCOVA|||||||0.633
71926905|NCT04342390|143374277|SUPERIORITY|||||||0.433|||||||ANCOVA|||||||0.433
71926906|NCT04342390|143374278|SUPERIORITY|||||||0.822|||||||ANCOVA|||||||0.822
71926907|NCT04342390|143374279|SUPERIORITY|||||||0.554|||||||ANCOVA|||||||0.554
71926908|NCT04342390|143374280|SUPERIORITY|||||||0.186|||||||ANCOVA|||||||0.186
71926909|NCT04342390|143374281|SUPERIORITY|||||||0.921|||||||ANCOVA|||||||0.921
71926910|NCT00318357|143374301|SUPERIORITY|||||||0.007|||||||Regression, Cox|||Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.||||0.007
71926911|NCT03378921|143374304|SUPERIORITY|||||||0.183||||||The threshold for statistical significance was P = 0.05|Log Rank|||The sample size (n = 26) was calculated according to the estimation that the remission rate in the FMT group would be 80% and 25% in the placebo group during the follow-up of 1 year. This difference of 55% was considered to be clinically meaningful. The significance level was selected to be 1%, and the power was set to 90%.||||0.183
71926912|NCT01054443|143374357|OTHER||Cochran-Armitage Trend Test Statistic|0.173||||0.431|||||||Cochran-Armitage Trend Test|||The primary efficacy evaluation was to test if there was a linear relationship existing such that the higher the dose level, the larger the percentage of responders. The Cochran-Armitage trend test was employed by assigning the score 0, 0.5, 0.75, and 1 to placebo, lusutrombopag 0.5, 0.75, and 1.0 mg group, respectively, at the 0.025 level of significance (1-sided) to determine the test statistic for detecting a dose-response in the percentage of responders.||||0.431
71926913|NCT01054443|143374358|OTHER||LS Mean Difference|25544.0|||||TWO_SIDED|95.0|6202.8|44885.3|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||44885.3|6202.8|
71926914|NCT01054443|143374358|OTHER||LS Mean Difference|11801.3|||||TWO_SIDED|95.0|-8809.3|32411.9|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||32411.9|-8809.3|
71926915|NCT01054443|143374358|OTHER||LS Mean Difference|756.6|||||TWO_SIDED|95.0|-18794.3|20307.5|||||The difference of least squares means (LSMeans) between each of the lusutrombopag treatment groups and placebo was estimated after adjusting for the Baseline platelet count using analysis of covariance (ANCOVA).|||20307.5|-18794.3|
71926916|NCT02277665|143374448|SUPERIORITY|Chi-square|Odds Ratio (OR)|0.56|||=|0.33|TWO_SIDED|95.0|0.17|1.82|||Chi-squared|||||1.82|.17|= 0.33
71926917|NCT02277665|143374449|OTHER||Odds Ratio (OR)|0.32||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
71761187|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0016|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||-0.1|-0.6|0.0016
71926918|NCT02277665|143374450|OTHER||Odds Ratio (OR)|0.45|||=|0.16|TWO_SIDED|95.0|0.15|1.35|||Chi-squared|||||1.35|0.15|= 0.16
71926919|NCT02277665|143374451|SUPERIORITY||Means Ratio|0.97||||0.87|TWO_SIDED|95.0|0.66|1.42|||Chi-squared|||||1.42|0.66|0.87
71926920|NCT02277665|143374452|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71926921|NCT02277665|143374453|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71926922|NCT05279807|143374473|SUPERIORITY||Mean difference pre vs post treatment|-13.5|||<|0.001|TWO_SIDED|95.0|-14.5|-12.5|||Paired Samples T-Test|||Primary endpoint, verified on the single cohort of patients who completed the monotherapy run-in period, is calculated as the mean difference in sitting diastolic blood pressure between Visit 2 (Week 0, Baseline Visit of the combination therapy) and Visit 4 (Week 8, End of Study Visit). This is not a comparison of two different arms, but a comparison of two measurements taken from the same patient treated with combination therapy (single arm paired pre- vs. post-combination therapy comparison)||-12.5|-14.5|< 0.001
71926923|NCT05981365|143374519|OTHER||Ratio of Geometric LS Means|1.2629|||||TWO_SIDED|90.0|1.1673|1.3663||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3663|1.1673|
71926924|NCT05981365|143374519|OTHER||Ratio of Geometric LS Means|1.1845|||||TWO_SIDED|95.0|1.0758|1.3042||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3042|1.0758|
71926925|NCT05981365|143374520|OTHER||Ratio of Geometric LS Means|1.1929|||||TWO_SIDED|90.0|1.0215|1.393||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3930|1.0215|
71926926|NCT05981365|143374521|OTHER||Ratio of Geometric LS Means|1.1311|||||TWO_SIDED|90.0|1.0496|1.2189||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2189|1.0496|
71926927|NCT05981365|143374522|OTHER||Ratio of Geometric LS Means|0.8228||||||90.0|0.6992|0.9683||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9683|0.6992|
71926928|NCT05981365|143374523|OTHER||Ratio of Geometric LS Means|1.5738|||||TWO_SIDED|90.0|1.4523|1.7054||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.7054|1.4523|
71926929|NCT05981365|143374524|OTHER||Ratio of Geometric LS Means|1.1491|||||TWO_SIDED|90.0|1.0807|1.222||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2220|1.0807|
71926930|NCT05981365|143374524|OTHER||Ratio of Geometric LS Means|0.9494|||||TWO_SIDED|90.0|0.8759|1.0291||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0291|0.8759|
71926931|NCT05981365|143374525|OTHER||Ratio of Geometric LS Means|1.3316|||||TWO_SIDED|90.0|1.2558|1.4121||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4121|1.2558|
71926932|NCT05981365|143374526|OTHER||Ratio of Geometric LS Means|1.1282|||||TWO_SIDED|90.0|1.07|1.1896||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1896|1.0700|
71926933|NCT05981365|143374527|OTHER||Ratio of Geometric LS Means|0.8047|||||TWO_SIDED|90.0|0.7173|0.9027||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9027|0.7173|
71926934|NCT05981365|143374528|OTHER||Ratio of Geometric LS Means|2.0611|||||TWO_SIDED|90.0|1.8789|2.2609||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2609|1.8789|
71926935|NCT05981365|143374529|OTHER||Ratio of Geometric LS Means|1.1374|||||TWO_SIDED|90.0|1.0672|1.2122||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2122|1.0672|
71926936|NCT05981365|143374529|OTHER||Ratio of Geometric LS Means|0.9371|||||TWO_SIDED|90.0|0.8643|1.0162||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.0162|0.8643|
71926937|NCT05981365|143374530|OTHER||Ratio of Geometric LS Means|1.2713|||||TWO_SIDED|90.0|1.1939|1.3538||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3538|1.1939|
71926938|NCT05981365|143374531|OTHER||Ratio of Geometric LS Means|1.127|||||TWO_SIDED|90.0|1.0688|1.1883||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1883|1.0688|
71926939|NCT05981365|143374532|OTHER||Ratio of Geometric LS Means|0.7973|||||TWO_SIDED|90.0|0.7039|0.9031||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.9031|0.7039|
71926940|NCT05981365|143374533|OTHER||Ratio of Geometric LS Means|2.026|||||TWO_SIDED|90.0|1.8496|2.2193||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||2.2193|1.8496|
71926941|NCT05981365|143374534|OTHER||Ratio of Geometric LS Means|0.7909|||||TWO_SIDED|90.0|0.716|0.8737||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8737|0.7160|
71926942|NCT05981365|143374535|OTHER||Ratio of Geometric LS Means|1.0831|||||TWO_SIDED|90.0|0.9723|1.2065||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.2065|0.9723|
71926943|NCT05981365|143374536|OTHER||Ratio of Geometric LS Means|1.3138|||||TWO_SIDED|90.0|1.1871|1.4541||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.4541|1.1871|
71926944|NCT05981365|143374537|OTHER||Ratio of Geometric LS Means|0.7958|||||TWO_SIDED|90.0|0.742|0.8534||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8534|0.7420|
71926945|NCT05981365|143374538|OTHER||Ratio of Geometric LS Means|1.0322|||||TWO_SIDED|90.0|0.9531|1.1179||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1179|0.9531|
71926946|NCT05981365|143374539|OTHER||Ratio of Geometric LS Means|1.1975|||||TWO_SIDED|90.0|1.0972|1.3069||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3069|1.0972|
71926947|NCT05981365|143374540|OTHER||Ratio of Geometric LS Means|0.8018|||||TWO_SIDED|90.0|0.7472|0.8604||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||0.8604|0.7472|
71926948|NCT05981365|143374541|OTHER||Ratio of Geometric LS Means|1.063|||||TWO_SIDED|90.0|0.9888|1.1427||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.1427|0.9888|
71926949|NCT05981365|143374542|OTHER||Ratio of Geometric LS Means|1.2197|||||TWO_SIDED|90.0|1.1114|1.3385||||||Analysis was performed using linear mixed model, with treatment as fixed effect and participant as random effect.||1.3385|1.1114|
71926950|NCT02203305|143374613|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: Interval and condition (p\<0.001).||Recorded 50-word consonant-nucleus-consonant (CNC) words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
71926951|NCT02203305|143374613|SUPERIORITY||||||<|0.001||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and condition (p\<0.001). Interaction: interval and condition (p\<0.001).||Recorded 50-word CNC words were evaluated for the poorer hearing ear 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction. Percent correct converted to RAU.||||<0.001
71926952|NCT02203305|143374613|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71926953|NCT02203305|143374613|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded 50-word CNC words were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71926954|NCT02203305|143374613|SUPERIORITY||||||<|0.429||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Main effects: interval (p\<0.001) and group (p=0.429). Interaction: group and interval (p=0.387).||Comparison of word recognition between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.429
71926955|NCT02203305|143374614|SUPERIORITY||||||<|0.019||||||The Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.19) and condition (p\<0.001). Interaction: interval and condition (p\<0.019).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.019
71926956|NCT02203305|143374614|SUPERIORITY||||||<|0.012||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.012) and condition (p\<0.001). Interaction: interval and condition (p=0.004).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.012
71689637|NCT04846270|142895599|OTHER|||||||0.0006|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of manual checks has been reduced.||"POWER is a single arm investigation with cross-over design. Each participating subject will use the study device and act as its own control.~The null hypothesis (H0) is that there is no difference in the mean number of checks performed during the investigation week compared to the baseline week.~The alternate hypothesis (H1) is that there is a reduction in the mean number of checks performed during the investigation week compared to the baseline week."||||0.0006
71689638|NCT04846270|142895601|OTHER|||||||0.0051|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of leakages had been reduced.||||||0.0051
71689639|NCT04846270|142895604|OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|A Wilcoxon Signed-Rank test was used to test if the number of fecal incidents had been reduced.||||||0.76
71689640|NCT00828061|142895617|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.25||||0.002||95.0|0.12|0.54||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.54|0.12|0.002
71689641|NCT00828061|142895617|SUPERIORITY_OR_OTHER||Geometric Mean Fold Difference|0.07|||<|0.001||95.0|0.03|0.15||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.||||0.15|0.03|<0.001
71689642|NCT00828061|142895618|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.537||95.0|-15.48|17.26||1-sided, alpha = 0.05|ANOVA|||||17.26|-15.48|0.537
71689643|NCT01400906|142895619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||||TWO_SIDED|95.0|-0.037|0.38|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.380|-0.037|
71689644|NCT01400906|142895619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|||||TWO_SIDED|95.0|-0.047|0.37|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.370|-0.047|
71689645|NCT01400906|142895624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.638|||||TWO_SIDED|95.0|0.44|0.836|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.836|0.440|
71689646|NCT01400906|142895624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.661|||||TWO_SIDED|95.0|0.463|0.859|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.859|0.463|
71689647|NCT01400906|142895625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.175|||||TWO_SIDED|95.0|0.018|0.333|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.333|0.018|
71689648|NCT01400906|142895625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|||||TWO_SIDED|95.0|0.008|0.323|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.323|0.008|
71689649|NCT01400906|142895626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.476|||||TWO_SIDED|95.0|0.326|0.627|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.627|0.326|
71689650|NCT01400906|142895626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53|||||TWO_SIDED|95.0|0.38|0.68|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|||0.680|0.380|
71689651|NCT03280056|142895678|SUPERIORITY||Odds Ratio (OR)|1.33||||0.453|TWO_SIDED|95.0|0.632|2.798|||Chi-squared|||||2.798|0.632|0.453
71689652|NCT03280056|142895679|SUPERIORITY||Odds Ratio (OR)|0.998||||0.997|TWO_SIDED|95.0|0.416|2.395|||Chi-squared|||||2.395|0.416|0.997
71689653|NCT03280056|142895680|SUPERIORITY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.926||0.693|TWO_SIDED|95.0|-1.47|2.2|||Mixed Models Analysis|||||2.20|-1.47|0.693
71689654|NCT03280056|142895681|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|6.176||0.804|TWO_SIDED|95.0|-10.65|13.72|||ANCOVA|||||13.72|-10.65|0.804
71689655|NCT02144077|142895682|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority margin of -15%|Difference in Percentage|1.6|||<|0.0001|ONE_SIDED|97.5|-6.5||||Farrington and Manning Test|Difference of proportions|||||-6.5|<0.0001
71689656|NCT00169104|142895716|SUPERIORITY||Mean Difference (Net)|-0.2|||>|0.05|TWO_SIDED|||||t=-0.29|t-test, 2 sided|df=15||T test||||>0.05
71689657|NCT00141518|142895739|SUPERIORITY_OR_OTHER||mean change from baseline|-9.4|STANDARD_DEVIATION|17.5||0.017|TWO_SIDED||||||Wilcoxon tests|||Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.017
71689658|NCT00141518|142895740|SUPERIORITY_OR_OTHER||mean change from baseline|0.02|STANDARD_DEVIATION|0.29||0.919|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.919
71689659|NCT00141518|142895741|SUPERIORITY_OR_OTHER||mean change from baseline|0.18|STANDARD_DEVIATION|0.24||0.002|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)||||0.002
71926957|NCT02203305|143374614|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71926958|NCT02203305|143374614|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71926959|NCT02203305|143374614|OTHER|correlation|bivariate pearson correlation|0.42|||=|0.033|TWO_SIDED||||||bivariate pearson correlation|||Association of age at implantation and sound source localization (RMS) at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.033
71926960|NCT02203305|143374614|SUPERIORITY||||||<|0.249||||||There were significant main effects of group (p\<0.001) and interval (p\<0.001). There was a non-significant interaction between group and interval (p=0.249).|Mixed Models Analysis|Main effects: group (p\<0.001) and interval (p\<0.001). Interaction: group and interval (p=0.249).||Comparison of sound source localization between groups (UHL/SSD and AHL) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.249
71926961|NCT02203305|143374615|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Speech, Spatial, \& Qualities of hearing scale (SSQ) as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
71926962|NCT02203305|143374615|SUPERIORITY||||||=|0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.056
71926963|NCT02203305|143374615|SUPERIORITY||||||<|0.448||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.488).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.448
71926964|NCT02203305|143374615|SUPERIORITY||||||<|0.299||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: subscale (p\<0.001) and interval (p=0.072). Interaction: subscale and interval (p=0.299).||Responses on the SSQ over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). Subscales include: speech, spatial, and qualities of hearing. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.299
71926965|NCT02203305|143374615|SUPERIORITY||||||<|0.018||||||There were significant main effects of interval (p\<0.001) and pragmatic subscale (p\<0.001), and their interaction (p\<0.018).|Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.018).||Responses on the SSQ Speech pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.018
71926966|NCT02203305|143374615|SUPERIORITY||||||<|0.767|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p=0.767). Interaction: interval and pragmatic subscale (p=0.542).||Responses on the SSQ Spatial pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.767
71926967|NCT02203305|143374615|SUPERIORITY||||||<|0.242|||||||Mixed Models Analysis|Main effects: interval (p=0.003) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.242).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.242
71926968|NCT02203305|143374615|OTHER|Bivariate pearson correlation||||||0.37|||||||bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||0.370
71926969|NCT02203305|143374615|OTHER|bivariate pearson correlation|||||=|0.865||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.865
71926970|NCT02203305|143374615|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.6|||=|0.005|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.005
71926971|NCT02203305|143374615|OTHER|bivariate pearson correlation|bivariate pearson correlation|0.67|||=|0.006|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Speech Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.006
71926972|NCT02203305|143374615|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.33|||=|0.152|TWO_SIDED||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.152
71926973|NCT02203305|143374615|OTHER|bivariate pearson correlation|||||=|0.761|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the preoperative interval and sound source localization (RMS error).||||=0.761
71926974|NCT02203305|143374615|OTHER|bivariate pearson correlation|||||=|0.315|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.315
71926975|NCT02203305|143374615|OTHER|bivariate pearson correlation|||||=|0.666|||||||bivariate pearson correlation|||Association of subjective benefit (Spatial Subscale) at the 12-month interval and sound source localization (RMS error).||||=0.666
71926976|NCT02203305|143374615|SUPERIORITY||||||>|0.175|||||||Mixed Models Analysis|Main effects: cohort (p=0.912), interval (p=0.463), and subscale (p=0.483). Interactions: 2-way or 3-way (p\>0.175).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the speech, spatial, and qualities of hearing subscales during the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.175
71926977|NCT02203305|143374616|SUPERIORITY||||||<|0.161||||||"Significant effect of interval (p=0.046) and of condition (p\<0.001) and a non-significant interaction (p=0.161).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: interval (p=0.046) and condition (p\<0.001). Interaction: interval and condition (p=0.161).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.161
71926978|NCT02203305|143374616|SUPERIORITY||||||>|0.107||||||"Significant effect of condition (p\<0.001) and the interaction (p\<0.001). Non-significant effect of interval (p=0.107).~Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis."|Mixed Models Analysis|Main effects: condition (p\<0.001) and interval p=0.107). Interaction of condition and interval (p\<0.001).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.107
71926979|NCT02203305|143374616|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71926980|NCT02203305|143374616|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||<0.001
71926981|NCT02203305|143374616|OTHER|bivariate pearson correlation|||||=|0.58||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of age at implantation and speech recognition in noise at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation.||||=0.580
71926982|NCT02203305|143374616|SUPERIORITY||||||<|0.743||||||A logit transformation was applied to proportion correct data prior to analysis.|Mixed Models Analysis|Effects: SNR (p=0.026) \& masker condition (p\<0.001). Interactions: cohort \& condition (p\<0.001), interval \& condition (p=0.015). Others (p\>0.140).||Comparison of speech recognition between groups (UHL/SSD and AHL) for the three masker configurations (noise towards the better hearing ear, noise towards the poorer hearing ear, and noise from the front) and signal-to-noise ratio (SNR; 0, 5, or 10 dB SNR) over the post-activation intervals (1, 3, 6, 9, and 12 months).||||<0.743
71926983|NCT02203305|143374616|OTHER|pearson correlation|||||=|0.036||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||=0.036
71926984|NCT02203305|143374617|SUPERIORITY||||||<|0.183||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.183) and condition (p=0.012). Interaction: interval and condition (p=0.081).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.183
71926985|NCT02203305|143374617|SUPERIORITY||||||<|0.196||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: interval (p=0.010) and condition (p=0.100). Interaction: interval and condition (p=0.196).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.196
71926986|NCT02203305|143374617|SUPERIORITY|||||||0.056||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||0.056
71926987|NCT02203305|143374617|SUPERIORITY||||||=|0.21||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Variable error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||=0.210
71926988|NCT02203305|143374618|SUPERIORITY||||||<|0.071||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.071) and condition (p\<0.001). Interaction: interval and condition (p\<0.051)||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.071
71689660|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-6.5|STANDARD_DEVIATION|9.6||0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)||||0.001
71689661|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-9.2|STANDARD_DEVIATION|9.0|<|0.001|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)||||<0.001
71689662|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-5.9|STANDARD_DEVIATION|11.2||0.022|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)||||0.022
71926989|NCT02203305|143374618|SUPERIORITY||||||<|0.109||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.109) and condition (p\<0.001). Interaction: interval and condition (p=0.052).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.109
71926990|NCT02203305|143374618|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71926991|NCT02203305|143374618|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71926992|NCT02203305|143374619|SUPERIORITY||||||<|0.024||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.018) and condition (p\<0.001). Interaction: interval and condition (p=0.024).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.024
71926993|NCT02203305|143374619|SUPERIORITY||||||<|0.219|||||||Mixed Models Analysis|Main effects: interval (p=0.187) and condition (p\<0.001). Interaction: interval and condition (p=0.219).||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval, condition (unaided or with the cochlear implant), and their interaction.||||<0.219
71926994|NCT02203305|143374619|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effect of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71926995|NCT02203305|143374619|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 60, 70, or 80 decibel (dB) sound pressure level (SPL) in a sound treated room. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response. A repeated-measures ANOVA evaluated the effects of interval (pre-operatively, 1, 3, 6, 9, and 12 months post). Pre-op: unaided, Post: bilateral.||||<0.001
71926996|NCT02203305|143374620|SUPERIORITY||||||=|0.011||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the Abbreviated Profile of Hearing Aid Benefit (APHAB) as measured with the global score were compared over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||=0.011
71926997|NCT02203305|143374620|SUPERIORITY||||||=|0.264||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses were compared to responses over the post-activation period (1, 3, 6, 9, and 12 months) with the cochlear implant using a repeated-measures ANOVA.||||=0.264
71926998|NCT02203305|143374620|SUPERIORITY||||||<|0.023||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p=0.005) and subscales (p=0.001). Interaction: interval and subscales (p=0.023).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.023
71926999|NCT02203305|143374620|SUPERIORITY||||||<|0.643|||||||Mixed Models Analysis|Main effects: interval (p=0.643) and subscale (p=0.005). Interaction: interval and subscale (p=0.480).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction over time with the cochlear implant (1, 3, 6, 9, and 12 months post-activation).||||<0.643
71927000|NCT02203305|143374620|OTHER|bivariate pearson correlation (one-tailed)|||||=|0.947||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.947
71689663|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-7.5|STANDARD_DEVIATION|11.6||0.005|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)||||0.005
71927001|NCT02203305|143374620|SUPERIORITY||||||=|0.5||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the preoperative interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.500
71927002|NCT02203305|143374620|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.51|||=|0.023|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.023
71927003|NCT02203305|143374620|OTHER|bivariate pearson correlation|bivariate pearson correlation|-0.55|||=|0.033|TWO_SIDED|||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|bivariate pearson correlation|||Association of subjective benefit (Noise Subscale) at the 12-month interval and speech recognition with AzBio sentences when the target is from the front and the masker is towards the acoustic ear.||||=0.033
71927004|NCT02203305|143374620|SUPERIORITY||||||>|0.208|||||||Mixed Models Analysis|Main effects: cohort (p=0.541), interval (p=0.446), and subscale (p=0.208). Interactions: 2-way or 3-way (p\>0.287).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the ease of communication, background noise, and reverberation subscales over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.208
71927005|NCT02203305|143374621|SUPERIORITY||||||=|0.221||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.221
71927006|NCT02203305|143374621|SUPERIORITY||||||=|0.538||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared over the post-activation time period (1, 3, 6, 9, and 12 months)."||||=0.538
71927007|NCT02203305|143374621|SUPERIORITY||||||>|0.218||||||There were no significant main effects of cohort (p=0.265) or interval (p=0.430). There was no significant interaction between cohort and interval (p=0.218).|Mixed Models Analysis|Main effects: cohort (p=0.265) or interval (p=0.430). Interaction: cohort and interval (p=0.218).||Comparison of subjective benefit between groups (UHL/SSD and AHL) on the Tinnitus Handicap Inventory over the post-activation intervals (1, 3, 6, 9, and 12 months).||||>0.218
71927008|NCT02203305|143374622|SUPERIORITY||||||<|0.322||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.084) and condition (p=0.322). Interaction: interval and condition (p=0.125).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.322
71927009|NCT02203305|143374622|SUPERIORITY||||||<|0.317||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: interval (p=0.014) and condition (p=0.317). Interaction: interval and condition (p=0.118).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.317
71927010|NCT02203305|143374622|SUPERIORITY||||||=|0.017||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.017
71927011|NCT02203305|143374622|SUPERIORITY||||||=|0.292||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.292
71927012|NCT02203305|143374622|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
71927013|NCT02203305|143374623|SUPERIORITY||||||<|0.581||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effect: interval (p=0.039) and condition (p=0.007). Interaction: interval and condition (p=0.581).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.581
71689664|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-5.3|STANDARD_DEVIATION|13.9||0.126|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)||||0.126
71689665|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-5.2|STANDARD_DEVIATION|12.3||0.049|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)||||0.049
71927014|NCT02203305|143374623|SUPERIORITY||||||<|0.817||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|Mixed Models Analysis|Main effects: condition (p=0.005) and interval (p=0.528). Interaction: condition and interval (p=0.817).||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.817
71927015|NCT02203305|143374623|SUPERIORITY||||||=|0.008||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.008
71927016|NCT02203305|143374623|SUPERIORITY||||||=|0.009|||||||ANOVA|||Recorded AzBio sentences in a 10-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation). Percent correct converted to RAU.||||=0.009
71927017|NCT02203305|143374623|OTHER|bivariate correlation|||||=|0.049||||||"Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.~This correlation was no longer significant when controlling for the hearing threshold at 8000 Hz."|bivariate pearson correlation|||Association of age at implantation and performance at the 12-month interval with the cochlear implant, analyzed with a Bivariate Pearson correlation (one-tailed).||||=0.049
71927018|NCT02203305|143374623|OTHER|pearson correlation|||||>|0.185|||||||bivariate pearson correlation|||Association of word recognition and speech recognition in noise, analyzed with a Bivariate Pearson correlation. Scores were averaged between 3 and 12 months post-activation as an estimate of asymptotic performance.||||>0.185
71927019|NCT02203305|143374624|SUPERIORITY||||||<|0.44|||||||Mixed Models Analysis|Main effects: interval (p=0.070) and condition (p=0.440). Interaction: interval and condition (p=0.047).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.440
71927020|NCT02203305|143374624|SUPERIORITY||||||<|0.379|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.250). Interaction: interval and condition (p=0.379).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.379
71927021|NCT02203305|143374624|SUPERIORITY||||||=|0.021|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.021
71927022|NCT02203305|143374624|SUPERIORITY||||||<|0.001|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
71927023|NCT02203305|143374625|SUPERIORITY||||||<|0.639||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effect: condition (p\<0.001) and interval (p=0.639). Interaction: interval and condition (p=0.280).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.639
71927024|NCT02203305|143374625|SUPERIORITY||||||<|0.637|||||||Mixed Models Analysis|Main effects: condition (p\<0.001) and interval (p=0.637). Interaction: interval and condition (p=0.450).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.637
71689666|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|-3.1|STANDARD_DEVIATION|9.9||0.203|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)||||0.203
71689667|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|0.8|STANDARD_DEVIATION|13.2||0.733|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)||||0.733
71689668|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|4.4|STANDARD_DEVIATION|14.3||0.414|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)||||0.414
71689669|NCT00141518|142895768|SUPERIORITY_OR_OTHER||mean change from baseline|2.3|STANDARD_DEVIATION|14.9||0.534|TWO_SIDED||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)||||0.534
71689670|NCT00141518|142895777|SUPERIORITY_OR_OTHER|||||||0.016|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.016
71689671|NCT00141518|142895777|SUPERIORITY_OR_OTHER|||||||0.188|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.188
71927025|NCT02203305|143374625|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||<0.001
71927026|NCT02203305|143374625|SUPERIORITY||||||=|0.002|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.002
71927027|NCT02203305|143374626|SUPERIORITY||||||<|0.671|||||||Mixed Models Analysis|Main effects: interval (p=0.020) and condition (p=0.406). Interaction: interval and condition (p=0.671).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||<0.671
71927028|NCT02203305|143374626|SUPERIORITY||||||>|0.124|||||||Mixed Models Analysis|Main effects: interval (p=0.124) and condition (p=0.845). Interaction: interval and condition (p=0.960).||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) unaided and 2) with the cochlear implant (CI) over the post-activation study period. Results are reported in dB SNR, where a lower value indicates better performance. A repeated-measures ANOVA evaluated the main effects of interval (1, 3, 6, 9, and 12 months post-activation), condition (unaided or with the CI), and their interaction.||||>0.124
71927029|NCT02203305|143374626|SUPERIORITY||||||=|0.025|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.025
71927030|NCT02203305|143374626|SUPERIORITY||||||=|0.442|||||||ANOVA|||Recorded BKB sentences in a 4-talker masker were evaluated in an unaided condition for the poorer hearing ear pre-operatively and with the cochlear implant (CI) over the study period. A repeated-measures ANOVA evaluated the main effect of interval (before surgery, and 1, 3, 6, 9, and 12 months post-activation).||||=0.442
71689672|NCT00141518|142895778|SUPERIORITY_OR_OTHER|||||||0.008|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.008
71689673|NCT00141518|142895778|SUPERIORITY_OR_OTHER|||||||0.107|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.107
71689674|NCT00141518|142895779|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
71689675|NCT00141518|142895779|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.010
71689676|NCT00141518|142895780|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
71689677|NCT00141518|142895780|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
71689678|NCT00141518|142895781|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.001
71689679|NCT00141518|142895781|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.003
71689680|NCT00141518|142895782|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||1.000
71689681|NCT00141518|142895782|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.002
71689682|NCT00141518|142895783|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.017
71689683|NCT00141518|142895783|SUPERIORITY_OR_OTHER|||||||0.191|||||||Wilcoxon tests|||||||0.191
71689684|NCT00141518|142895784|SUPERIORITY_OR_OTHER|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.002
71689685|NCT00141518|142895784|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||<0.001
71689686|NCT00141518|142895785|SUPERIORITY_OR_OTHER|||||||0.047|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.047
71689687|NCT00141518|142895785|SUPERIORITY_OR_OTHER|||||||0.847|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.847
71689688|NCT00141518|142895786|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.012
71689689|NCT00141518|142895786|SUPERIORITY_OR_OTHER|||||||0.035|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.035
71689690|NCT00141518|142895787|SUPERIORITY_OR_OTHER|||||||0.599|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.599
71689691|NCT00141518|142895787|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
71689692|NCT00141518|142895788|SUPERIORITY_OR_OTHER|||||||0.026|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.026
71689693|NCT00141518|142895788|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.208
71689694|NCT00141518|142895789|SUPERIORITY_OR_OTHER|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.010
71689695|NCT00141518|142895789|SUPERIORITY_OR_OTHER|||||||0.073|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.073
71689696|NCT00141518|142895790|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.048
71689697|NCT00141518|142895790|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.030
71927031|NCT02203305|143374627|SUPERIORITY||||||<|0.001||||||Percent correct values were converted to rationalized arcsine units prior to analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
71927032|NCT02203305|143374627|SUPERIORITY||||||<|0.001||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|t-test, 2 sided|||Paired samples t-test comparing word recognition (percent correct for CNC words) with a hearing aid at the pre-operative interval and the cochlear implant at the 12-month interval for the affected ear (masking presented to the contralateral ear).||||<0.001
71927033|NCT02203305|143374628|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listened with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
71927034|NCT02203305|143374628|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Participants listening with a bone conduction device preoperatively and with the cochlear implant at 1, 3, 6, 9, and 12 months post-activation. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Repeated-measures ANOVA compared performance over time.||||<0.001
71927035|NCT02203305|143374628|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
71927036|NCT02203305|143374628|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Compare localization performance with the cochlear implant to a bone-conduction device at the 12-month interval using a paired samples t-test.||||<0.001
71927037|NCT02203305|143374629|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
71689698|NCT00141518|142895791|SUPERIORITY_OR_OTHER|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores||||0.208
71689699|NCT00141518|142895791|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores||||0.048
71689700|NCT00237692|142895819|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.7|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.7|
71689701|NCT00237692|142895819|SUPERIORITY_OR_OTHER||Est. % of patients with controled SBP|59.8|||||TWO_SIDED|95.0|55.7|64.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||64.0|55.7|
71689702|NCT00237692|142895819|SUPERIORITY_OR_OTHER||Est. % of patinets with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at Baseline||63.9|55.6|
71689703|NCT00237692|142895819|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.8|||||TWO_SIDED|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline||63.9|55.6|
71689704|NCT00237692|142895820|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|58.0|||||TWO_SIDED|95.0|49.3|66.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 6 months.||66.7|49.3|
71689705|NCT00237692|142895820|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|60.9|||||TWO_SIDED|95.0|52.5|69.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||69.3|52.5|
71689706|NCT00237692|142895820|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|65.0|||||TWO_SIDED|95.0|56.9|73.1|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||73.1|56.9|
71689707|NCT00237692|142895820|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.8|||||TWO_SIDED|95.0|55.6|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.||72.0|55.6|
71689708|NCT00237692|142895820|SUPERIORITY_OR_OTHER||% diff|2.9|||||TWO_SIDED|95.0|-9.0|14.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.||14.9|-9.0|
71927038|NCT02203305|143374629|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is calculated from the responses on the ease of communication, reverberation, and effectiveness in background noise subscales. Responses at the preoperative interval (alternative treatments for unilateral hearing loss) were compared to responses over time with the cochlear implant using a repeated-measures ANOVA.||||<0.001
71927039|NCT02203305|143374629|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p\<0.001). Interaction: interval and subscales (p\<0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.001
71927040|NCT02203305|143374629|SUPERIORITY||||||<|0.01||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscales (p=0.010). Interaction: interval and subscales (p=0.001).||The Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Subscales include: ease of communication, reverberation, effectiveness in background noise, and reverberation. A repeated-measures ANOVA compared the main effects of interval and subscale and their interaction from the preoperative interval (alternative treatments) and over time with the cochlear implant.||||<0.010
71927041|NCT02203305|143374630|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||<0.001
71927042|NCT02203305|143374630|SUPERIORITY||||||=|0.003||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||"The Tinnitus Handicap Inventory is a 25-item questionnaire. The subject answers yes (4 points), sometimes (2 points), or no (0 points) to each question. Responses are added to quantify tinnitus severity: none/slight (0-16), mild (18-36), moderate (38-56), severe (58-76), and catastrophic (78-100). Responses were compared at the preoperative interval (alternative treatments) and over the post-activation time period (1, 3, 6, 9, and 12 months) with the cochlear implant."||||=0.003
71927043|NCT02203305|143374631|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
71927044|NCT02203305|143374631|SUPERIORITY||||||<|0.001||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|||Responses on the SSQ as measured with the total score were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months).||||<0.001
71927045|NCT02203305|143374631|SUPERIORITY||||||<|0.001||||||"There were significant main effects of interval (p\<0.001) and subscale (p\<0.001) and interaction (p=0.001).~A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity."|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.001).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for SSD) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.001
71927046|NCT02203305|143374631|SUPERIORITY||||||<|0.034||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|Mixed Models Analysis|Main effects: interval (p\<0.001) and subscale (p\<0.001). Interaction: interval and subscale (p=0.034).||Responses on the SSQ as measured with the subscales (speech, spatial, \& qualities) were compared at the preoperative interval (alternative treatments for asymmetric hearing loss) and over the post-activation period (i.e., 1, 3, 6, 9, and 12 months). A repeated-measures ANOVA assessed the main effects of interval and subscale, and their interaction.||||<0.034
71927047|NCT02203305|143374631|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
71927048|NCT02203305|143374631|SUPERIORITY||||||<|0.192|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.192). Interaction: interval and pragmatic subscale (p=0.001).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.192
71927049|NCT02203305|143374631|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p\<0.001).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.001
71927050|NCT02203305|143374631|SUPERIORITY||||||<|0.479|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.479).||Responses on the SSQ Speech pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.479
71927051|NCT02203305|143374631|SUPERIORITY||||||<|0.804|||||||Mixed Models Analysis|Main effect: interval (p\<0.001) and pragmatic subscale (p=0.804). Interaction: interval and pragmatic subscale (p=0.090).||Responses on the SSQ Spatial pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.804
71689709|NCT00237692|142895820|SUPERIORITY_OR_OTHER||% Diff|6.9|||||TWO_SIDED|95.0|-4.7|18.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.||18.7|-4.7|
71689710|NCT00237692|142895820|SUPERIORITY_OR_OTHER||% Diff|5.7|||||TWO_SIDED|95.0|-6.0|17.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 6months.||17.6|-6.0|
71927052|NCT02203305|143374631|SUPERIORITY||||||<|0.005|||||||Mixed Models Analysis|Main effects: interval (p\<0.001) and pragmatic subscale (p\<0.001). Interaction: interval and pragmatic subscale (p=0.005).||Responses on the SSQ Qualities of Hearing pragmatic subscale over the study period (i.e., preoperative, and 1, 3, 6, 9, and 12 months post-activation). A repeated-measures ANOVA compared the main effects of interval and pragmatic subscale and their interaction over time.||||<0.005
71927053|NCT02203305|143374632|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
71927054|NCT02203305|143374632|SUPERIORITY||||||=|0.034|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.034
71927055|NCT02203305|143374633|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
71927056|NCT02203305|143374633|SUPERIORITY||||||=|0.037|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.037
71927057|NCT02203305|143374634|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||<0.001
71927058|NCT02203305|143374634|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.||||=0.001
71927059|NCT02203305|143374635|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) with a bone-conduction device (preoperative interval) and 2) with the cochlear implant (CI) at the 12-month post-activation interval. Results are reported in dB SNR, where a lower value indicates better performance. A paired samples t-test compared the performance with the two devices.||||=0.004
71927060|NCT02203305|143374635|SUPERIORITY||||||=|0.004|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.004
71927061|NCT02203305|143374636|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||<0.001
71927062|NCT02203305|143374636|SUPERIORITY||||||=|0.727|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.727
71927063|NCT02203305|143374637|SUPERIORITY||||||=|0.001|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.001
71927064|NCT02203305|143374637|SUPERIORITY||||||=|0.09|||||||t-test, 2 sided|||Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance.||||=0.090
71927065|NCT02203305|143374643|SUPERIORITY||||||<|0.923|||||||Mixed Models Analysis|Main effect: electrode (p\<0.001), target stimulus (p=0.923), and interval (p=0.226). Interaction: electrode and interval (p=0.496).||A linear mixed effects model compared the main effects of target stimulus (click, tone), electrode (1-5), and interval (1, 3, 6, and 12 months) on the normalized pitch match.||||<0.923
71927066|NCT02203305|143374643|OTHER||||||>|0.164|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and word recognition with the CI alone.||||>0.164
71927067|NCT02203305|143374643|OTHER|bivariate pearson correlation|||||>|0.367|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and speech recognition in noise (masker from the front, masker towards the better hearing ear, and masker towards the poorer hearing ear).||||>0.367
71927068|NCT02203305|143374643|OTHER|bivariate pearson correlation|||||>|0.349|||||||bivariate pearson correlation|||Correlation between pitch perception (normalized mean pitch match) and sound source localization (RMS error).||||>0.349
71927069|NCT02203305|143374644|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||"Comparison of the unaided threshold at 125 Hz at the preoperative and initial activation intervals for the 25 participants with unaided threshold of 80 dB HL or better at the preoperative interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||<0.001
71927070|NCT02203305|143374644|SUPERIORITY||||||=|0.47|||||||ANOVA|generalized linear mixed-effects model||"Comparison of the unaided threshold at 125 Hz from the initial activation to the 12-month post-activation interval for the 9 participants with an unaided threshold of 95 dB HL or better at the initial activation interval.~The data from the SSD and AHL group were combined to review hearing preservation with long arrays. The inclusion criteria for the implanted ear were the same for the SSD and AHL groups and all subjects received the same 31.5 mm electrode array."||||=0.47
71927071|NCT02203305|143374645|SUPERIORITY||||||=|0.739|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.739
71927072|NCT02203305|143374645|SUPERIORITY||||||=|0.553|||||||t-test, 2 sided|||A paired samples t-test compared the performance with the bone-conduction device at the preoperative and 12-month intervals.||||=0.553
71927073|NCT02203305|143374646|SUPERIORITY||||||<|0.345||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: interval (p=0.027) and masker condition (p\<0.001). Interaction: interval and masker condition (p=0.345).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.345
71927074|NCT02203305|143374646|SUPERIORITY||||||<|0.577||||||Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis.|ANOVA|Main effect: masker condition (p\<0.001) and interval (p=0.577). Interaction: interval and masker condition (p=0.055).||A repeated-measures ANOVA assessed the effects of interval (preoperative and 12-months) and masker condition (front, acoustic ear, or affected ear) on performance with the bone conduction device.||||<0.577
71927075|NCT02203305|143374647|SUPERIORITY||||||>|0.023|||||||Mixed Models Analysis|Main effect: coding strategy (p=0.023). Interaction: coding strategy and electrode (p=0.044). All other main effects and interactions were p\>0.160.||A linear mixed effect model assessed the main effects of stimulus, electrode, and coding strategy, and their interactions.||||>0.023
71927076|NCT02203305|143374647|SUPERIORITY||||||>|0.035|||||||t-test, 2 sided|Pitch perception for electrode 1 (p=0.035). All other comparisons were p\>0.318.||Paired samples t-tests evaluated whether pitch perception (mean normalized pitch) differed between coding strategy for each electrode.||||>0.035
71927077|NCT02203305|143374648|SUPERIORITY||||||>|0.084|||||||ANOVA|Main effects: condition (p=0.960) and interval (p=0.084). Interaction: condition and interval (p=0.433).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.084
71927078|NCT02203305|143374648|SUPERIORITY||||||>|0.434|||||||ANOVA|Main effect: condition (p=0.434) or interval (p=0.687). Interaction: condition and interval (p=0.678).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device) and interval (preoperative, 12-month) and their interaction on sound source localization.||||>0.434
71927079|NCT02203305|143374649|SUPERIORITY||||||<|0.935||||||Percent correct converted to rationalized arcsine units (RAU) prior to analysis.|ANOVA|Main effects: condition (p=0.018), interval (p=0.012), and masker (p\<0.001). Interactions: interval and masker (p\<0.001). Other interactions: p\>0.117.||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.935
71927080|NCT02203305|143374649|SUPERIORITY||||||<|0.977||||||A Greenhouse-Geisser correction was applied as indicated by the Mauchly test of sphericity.|ANOVA|Effects: interval (p=0.012) and masker (p\<0.001). Interactions: interval\&masker (p=0.020) \& condition, interval, \&masker (p=0.035). Others: (p\>0.131).||A repeated-measures ANOVA assessed the effects of condition (unaided, bone-conduction device), interval (preoperative, 12-month), and masker condition and their 2-way and 3-way interactions on speech recognition in noise.||||<0.977
71689711|NCT00237692|142895821|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.9|||||TWO_SIDED|95.0|51.4|68.3|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||68.3|51.4|
71927081|NCT01005810|143374650|SUPERIORITY||Odds Ratio (OR)|2.35||||0.029|TWO_SIDED|95.0|1.05|5.24|||Regression, Logistic|||||5.24|1.05|0.029
71927082|NCT01453296|143374673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
71927083|NCT01453296|143374673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
71927084|NCT01453296|143374673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 maximum HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
71927085|NCT01453296|143374674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.5|||||TWO_SIDED|95.0|-0.8|5.7|||||Day 1 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-0.8|
71927086|NCT01453296|143374674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|||||TWO_SIDED|95.0|-2.4|3.7|||||Day 14 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.7|-2.4|
71689712|NCT00237692|142895821|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.1|||||TWO_SIDED|95.0|65.6|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months||80.7|65.6|
71927087|NCT01453296|143374674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|||||TWO_SIDED|95.0|-2.6|3.6|||||Day 14 weighted HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||3.6|-2.6|
71927088|NCT01453296|143374675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0|||||TWO_SIDED|95.0|-4.5|6.6|||||Day 1 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.6|-4.5|
71927089|NCT01453296|143374675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|||||TWO_SIDED|95.0|-3.2|6.3|||||Day 14 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.3|-3.2|
71927090|NCT01453296|143374675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|||||TWO_SIDED|95.0|-3.0|5.7|||||Day 14 maximum QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||5.7|-3.0|
71927091|NCT01453296|143374689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.01|||||TWO_SIDED|95.0|-2.59|6.61|||||Day 1 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||6.61|-2.59|
71927092|NCT01453296|143374689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|||||TWO_SIDED|95.0|-1.93|7.81|||||Day 14 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.81|-1.93|
71927093|NCT01453296|143374689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19|||||TWO_SIDED|95.0|-0.7|7.08|||||Day 14 weighted QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.|||7.08|-0.70|
71927094|NCT03557775|143374690|SUPERIORITY|||||||0.041||||||Result for time by group interaction (threshold for statistical significance set at 0.05).|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.041
71927095|NCT03557775|143374691|SUPERIORITY|||||||0.887||||||Result for time by group interaction. Statistical threshold set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
71927096|NCT03557775|143374692|SUPERIORITY|||||||0.733||||||Result for time by group interaction effect. Threshold for statistical significance was set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.733
71927097|NCT03557775|143374693|SUPERIORITY|||||||0.702||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.702
71927098|NCT03557775|143374694|SUPERIORITY|||||||0.198||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.198
71927099|NCT03557775|143374695|SUPERIORITY|||||||0.388||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.388
71927100|NCT03557775|143374696|SUPERIORITY|||||||0.296||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.296
71927101|NCT03557775|143374697|SUPERIORITY|||||||0.04||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.040
71927102|NCT03557775|143374698|SUPERIORITY|||||||0.887||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.887
71927103|NCT03557775|143374699|SUPERIORITY|||||||0.663||||||Result for time by group interaction effect. Threshold for statistical significance was set 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.663
71927104|NCT03557775|143374700|SUPERIORITY|||||||0.026||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.026
71927105|NCT03557775|143374701|SUPERIORITY|||||||0.721||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.721
71927106|NCT03557775|143374702|SUPERIORITY|||||||0.408||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.408
71927107|NCT03557775|143374703|SUPERIORITY|||||||0.638||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.638
71927108|NCT03557775|143374704|SUPERIORITY|||||||0.715||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.715
71927109|NCT03557775|143374705|SUPERIORITY|||||||0.708||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.708
71927110|NCT03557775|143374706|SUPERIORITY|||||||0.988||||||Result for time by group interaction effect. Threshold for statistical significance set at 0.05.|ANOVA|||Null hypothesis: there will be no significant time by group interaction effect for this variable.||||0.988
71927111|NCT00972309|143374829|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71927112|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.0001
71927113|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
71927114|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.01
71927115|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of thrombocytopenia adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
71927116|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.||||<0.05
71927117|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
71927118|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Monthly DP arm compared with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm||||<0.05
71927119|NCT00948896|143374831|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Daily TS arm compare with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the daily TS arm||||<0.01
71927120|NCT00948896|143374833|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|7.0||||0.57|TWO_SIDED|95.0|-19.0|28.0|||Negative Binomial Regression||The no chemoprevention arm is the reference group.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||28|-19|0.57
71927121|NCT00948896|143374833|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|28.0||||0.01|TWO_SIDED|95.0|7.0|44.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||44|7|0.01
71927122|NCT00948896|143374833|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|58.0|||<|0.001|TWO_SIDED|95.0|45.0|67.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||67|45|<0.001
71927123|NCT00948896|143374834|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|9.0||||0.065|TWO_SIDED|95.0|-35.0|38.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||38|-35|0.065
71927124|NCT00948896|143374834|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|49.0||||0.001|TWO_SIDED|95.0|23.0|66.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||66|23|0.001
71927125|NCT00948896|143374834|SUPERIORITY_OR_OTHER||Protective Efficacy (%)|69.0|||<|0.001|TWO_SIDED|95.0|53.0|80.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.||80|53|<0.001
71927126|NCT05405218|143374895|SUPERIORITY||Mean Difference (Net)|0.08||||0.46|TWO_SIDED|95.0|-0.13|0.29|||Mixed Models Analysis|||||0.29|-0.13|0.46
71927127|NCT05405218|143374896|SUPERIORITY||Mean Difference (Net)|0.01||||0.92|TWO_SIDED|95.0|-0.2|0.23|||Mixed Models Analysis|||||0.23|-0.2|0.92
71927128|NCT05405218|143374898|SUPERIORITY||Mean Difference (Net)|0.61||||0.09|TWO_SIDED|95.0|-0.08|1.3|||Mixed Models Analysis|||||1.3|-0.08|0.09
71927129|NCT05405218|143374899|SUPERIORITY||Mean Difference (Net)|0.0||||0.9|TWO_SIDED|95.0|-0.06|0.05|||Mixed Models Analysis|||||0.05|-0.06|0.9
71927130|NCT05436067|143374930|OTHER||||||<|0.001||||||Difference in head angle pitch - left between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
71927131|NCT05436067|143374930|OTHER||||||<|0.001||||||Difference in head angle pitch - right between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
71927132|NCT05436067|143374930|OTHER|||||||0.042||||||Difference in head angle yaw - extension between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.042
71927133|NCT05436067|143374930|OTHER|||||||0.111||||||Difference in head angle yaw - flexion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.111
71927134|NCT05436067|143374931|OTHER|||||||0.023||||||Difference in pitch range of motion between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.023
71927135|NCT05436067|143374931|OTHER||||||<|0.001|||||||paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||<0.001
71927136|NCT05436067|143374932|OTHER|||||||0.057||||||Difference in pitch velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.057
71927137|NCT05436067|143374932|OTHER|||||||0.003||||||Difference in yaw velocity between the arms|paired t-test|||This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test||||0.003
71927138|NCT05436067|143374933|OTHER|||||||0.035||||||Weight shift exercise - mediolateral range of motion|paired t-test|||||||0.035
71927139|NCT05436067|143374933|OTHER|||||||0.006||||||Weight shift balance exercise anteroposterior range of motion|paired t-test|||||||0.006
71927140|NCT05436067|143374933|OTHER|||||||0.024||||||Single leg balance range of motion|paired t-test|||||||0.024
71927141|NCT05436067|143374933|OTHER|||||||0.257||||||Single leg balance fluency|Shapiro Wilcoxon test|Data was not normally distributed.||||||0.257
71927142|NCT05689554|143374941|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.11|TWO_SIDED|95.0|0.944|1.306|||Log Rank|||||1.306|.944|0.11
71927143|NCT05689554|143374942|SUPERIORITY||Risk Ratio (RR)|1.24||||0.183|TWO_SIDED|95.0|0.9|1.7|||Regression, modified Poisson|||||1.7|.9|0.183
71927144|NCT00157820|143374943|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.31||||0.0028|TWO_SIDED|95.0|0.14|0.67|||Wilcoxon (Mann-Whitney)||An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an 'offset'.|"The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa \< 0.05 and a power of 88.8%.~The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up."||0.67|0.14|0.0028
71927145|NCT00563706|143374960|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-12.3||||0.043|TWO_SIDED|95.0|-24.24|-0.37|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||-0.37|-24.24|0.043
71927146|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.77||||0.457|TWO_SIDED|95.0|-24.7|11.16|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||11.16|-24.70|0.457
71927147|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-11.61||||0.067|TWO_SIDED|95.0|-24.03|0.81|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.81|-24.03|0.067
71927148|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.61||||0.567|TWO_SIDED|95.0|-16.02|8.8|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.80|-16.02|0.567
71927149|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-10.9||||0.07|TWO_SIDED|95.0|-22.71|0.92|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||0.92|-22.71|0.070
71927150|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.18||||0.647|TWO_SIDED|95.0|-16.87|10.5|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||10.50|-16.87|0.647
71927151|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.73||||0.075|TWO_SIDED|95.0|-20.46|1.0|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||1.00|-20.46|0.075
71927152|NCT00563706|143374960|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.44||||0.765|TWO_SIDED|95.0|-10.92|8.04|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.||8.04|-10.92|0.765
71927153|NCT00299546|143374970|SUPERIORITY_OR_OTHER||||||<|0.001||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX)||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a \>90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40\~55% ACR 20 response in golimumab groups.||||<0.001
71927154|NCT00299546|143374970|SUPERIORITY_OR_OTHER|||||||0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg.||||0.001
71927155|NCT00299546|143374970|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg.||||<0.001
71927156|NCT00299546|143374971|SUPERIORITY_OR_OTHER|||||||0.003|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||0.003
71927157|NCT00299546|143374971|SUPERIORITY_OR_OTHER|||||||0.021||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.021
71927158|NCT00299546|143374971|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
71927159|NCT00299546|143374972|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methorexate (MTX).||||||<0.001
71927160|NCT00299546|143374972|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
71927161|NCT00299546|143374972|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
71927162|NCT00299546|143374973|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).||||||<0.001
71927163|NCT00299546|143374973|SUPERIORITY_OR_OTHER|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||0.002
71927164|NCT00299546|143374973|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||||||<0.001
71927165|NCT00299546|143374974|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|Stratified by baseline Methotrexate (MTX).||||||<0.001
71927166|NCT00299546|143374974|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
71927167|NCT00299546|143374974|SUPERIORITY_OR_OTHER||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 \& 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.||||||<0.001
71927168|NCT03309072|143375006|OTHER|To compare the old and new faces' hit rate, we calculated the true positive rate (TPR: the proportion of positives that are correctly identified as such). A repeated measures ANOVA was conducted with the TPR for both old and new faces as within-subjects variable and group (active vs sham) as between-subjects variable.|Mean Difference (Net)|10.66|||<|0.049|TWO_SIDED||||||ANOVA||Difference between active tDCS and sham tDCS|||||<.049
71927169|NCT00124709|143375120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0046||||0.7901|TWO_SIDED|95.0|-0.029|0.0381|||ANCOVA|Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables||"A disease-free day in Step 2 or less was defined as a diary day with variable No or almost no eczema?=yes and medication used variable=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day."||0.0381|-0.0290|0.7901
71927170|NCT01728376|143375132|SUPERIORITY_OR_OTHER||Difference (%)|-2.5|||||TWO_SIDED|95.0|-30.3|25.3|||||Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||25.3|-30.3|
71927171|NCT01728376|143375132|SUPERIORITY_OR_OTHER||Difference (%)|16.3|||||TWO_SIDED|95.0|-13.0|45.7|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||45.7|-13.0|
71927172|NCT01728376|143375132|SUPERIORITY_OR_OTHER||Difference (%)|25.7|||||TWO_SIDED|95.0|-21.0|72.4|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved||72.4|-21.0|
71927173|NCT01728376|143375133|SUPERIORITY_OR_OTHER||Difference (%)|5.0|||||TWO_SIDED|95.0|-29.8|39.8|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||39.8|-29.8|
71927174|NCT01728376|143375133|SUPERIORITY_OR_OTHER||Difference (%)|37.9|||||TWO_SIDED|95.0|0.7|75.1|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||75.1|0.7|
71927175|NCT01728376|143375133|SUPERIORITY_OR_OTHER||Difference (%)|-10.0||||||95.0|-60.3|40.3|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms||40.3|-60.3|
71927176|NCT01683331|143375140|SUPERIORITY||Odds Ratio (OR)|1.03||||0.87|TWO_SIDED|95.0|1.01|1.06|||Chi-squared|||||1.06|1.01|0.87
71927177|NCT01683331|143375141|SUPERIORITY||Odds Ratio (OR)|1.3||||0.92|TWO_SIDED|95.0|1.2|2.8|||Chi-squared|||||2.8|1.2|0.92
71927178|NCT03491800|143375146|SUPERIORITY||Mean Difference (Net)|7.5|STANDARD_ERROR_OF_MEAN|0.15||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
71927179|NCT03491800|143375147|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.43||0.9|TWO_SIDED||||||t-test, 2 sided|||||||0.90
71927180|NCT03491800|143375147|SUPERIORITY||Mean Difference (Final Values)|4.44|STANDARD_ERROR_OF_MEAN|0.26||0.3|TWO_SIDED||||||t-test, 2 sided|||||||0.30
71927181|NCT03491800|143375148|SUPERIORITY||Mean Difference (Final Values)|-3.03|STANDARD_ERROR_OF_MEAN|-0.28||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
71927182|NCT03491800|143375148|SUPERIORITY||Mean Difference (Final Values)|0.93|STANDARD_ERROR_OF_MEAN|0.22||0.85|TWO_SIDED||||||t-test, 2 sided|||||||0.85
71927183|NCT03491800|143375149|SUPERIORITY||Mean Difference (Final Values)|-5.05|STANDARD_ERROR_OF_MEAN|-0.25||0.21|TWO_SIDED||||||t-test, 2 sided|||||||0.21
71927184|NCT03491800|143375150|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.23||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
71927185|NCT03491800|143375151|SUPERIORITY||Mean Difference (Final Values)|3.34|STANDARD_ERROR_OF_MEAN|-0.2||0.52|TWO_SIDED||||||t-test, 2 sided|||||||0.52
71927186|NCT03491800|143375152|SUPERIORITY||Mean Difference (Final Values)|-38.25|STANDARD_ERROR_OF_MEAN|-38.25||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
71927187|NCT03491800|143375152|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|22.0||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
71927188|NCT03491800|143375152|SUPERIORITY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|9.62||0.054|TWO_SIDED||||||t-test, 2 sided|||||||0.054
71927189|NCT03491800|143375153|SUPERIORITY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|5.4||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
71927190|NCT03491800|143375153|SUPERIORITY||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|3.29||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
71927191|NCT01256086|143375158|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Relative potency of Novolizer compared to Aerolizer. Equivalence was to be concluded if the CI for the relative potency was completely covered by the interval (0.67, 1.50) according to OIP Guideline.|Relative potency|1.13|||||TWO_SIDED|90.0|0.94|1.38|||||Fieller confidence interval for logarithm of relative potency|||1.38|0.94|
71927192|NCT05604521|143375161|SUPERIORITY|||||||0.3944|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any local solicited AEs after any vaccination.||||0.3944
71927193|NCT05604521|143375161|SUPERIORITY|||||||0.3717|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any systemic solicited AEs after any vaccination.||||0.3717
71927194|NCT05604521|143375161|SUPERIORITY|||||||1|||||||Fisher Exact|||Null hypothesis: There is no statistically significant difference between the vaccine and control groups in the proportion of participants experiencing any related unsolicited AEs after any vaccination.||||1.0
71927195|NCT01491737|143375162|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.007|TWO_SIDED|95.0|0.48|0.89||Test was performed at 2-sided alpha of 5%.|Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the PFS time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the PFS time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to PFS was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.89|0.48|0.0070
71927196|NCT01491737|143375162|OTHER|Exploratory|Hazard Ratio (HR)|0.67||||0.0059|TWO_SIDED|95.0|0.5|0.89|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis||0.89|0.50|0.0059
71927197|NCT01491737|143375163|OTHER|Exploratory|Hazard Ratio (HR)|1.15||||0.585|TWO_SIDED|95.0|0.69|1.91|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Primary Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.91|0.69|0.5850
71927198|NCT01491737|143375163|OTHER|Exploratory|Hazard Ratio (HR)|1.05||||0.7833|TWO_SIDED|95.0|0.73|1.52|||Log Rank|Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Hazard ratio comparing Arm A vs. B from stratified Cox proportional hazards model including stratification factors.|Final Analysis. This study was not powered for overall survival (OS), so adequately powered statistical testing for this outcome measure was not possible.||1.52|0.73|0.7833
71927199|NCT01491737|143375164|SUPERIORITY||Difference in ORR|7.6||||0.2537|TWO_SIDED|95.0|-6.0|21.3||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||ORR for Arm A vs Arm B||21.3|-6.0|0.2537
71927200|NCT01491737|143375165|SUPERIORITY||Difference in CBR|1.8||||0.7743|TWO_SIDED|95.0|-11.2|14.8||Test was performed at 2-sided alpha of 5%. There was no multiplicity adjustment.|Chi-squared|||CBR for Arm A vs. Arm B||14.8|-11.2|0.7743
71927201|NCT01491737|143375166|SUPERIORITY||Hazard Ratio (HR)|0.57||||0.0181|TWO_SIDED|95.0|0.36|0.91||Test was performed at 2-sided alpha of 5%.|Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Primary Analysis. Log Rank tested the following: Null Hypothesis (H0): the distribution of the DOR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the DOR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to DOR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||0.91|0.36|0.0181
71927202|NCT01491737|143375166|OTHER|Exploratory|Hazard Ratio (HR)|0.62||||0.0205|TWO_SIDED|95.0|0.41|0.93|||Log Rank|Log-rank test from unstratified analysis based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including stratification factors of induction chemotherapy and prior adjuvant hormone therapy.|Final Analysis.||0.93|0.41|0.0205
71927203|NCT01491737|143375167|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.5597|TWO_SIDED|95.0|0.78|1.57||Test was performed at 2-sided alpha of 5%.|Log Rank|The log-rank test from unstratified analysis was based upon Kaplan-Meier approach. There was no multiplicity adjustment.|Hazard ratio from stratified Cox proportional hazards model including the induction chemotherapy and prior adjuvant hormone therapy stratification factors.|Log Rank tested the following: Null Hypothesis (H0): the distribution of the TTR time was the same in Arms A \& B; The Alternative Hypothesis (H1): the distribution of the TTR time was different in Arms A \& B. A Cox proportional hazards model tested the HR. If the HR of investigational arm (Arm A) compared with control arm (Arm B) with respect to TTR was assumed to be constant over time (λ) then the null (H0) and alternative hypotheses (H1) were: H0: λ =1; H1: λ ≠1.||1.57|0.78|0.5597
71927204|NCT04311411|143375172|SUPERIORITY||Median Difference (Final Values)|-534.11|||<|0.0001|TWO_SIDED|95.0|-668.2|-400.02|||ANCOVA|||||-400.02|-668.20|<.0001
71927205|NCT04311411|143375173|SUPERIORITY||Median Difference (Final Values)|0.0439||||0.5437|TWO_SIDED|95.0|-0.0994|0.1871|||Mixed Models Analysis|||Insula||0.1871|-0.0994|0.5437
71927206|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|0.093||||0.1806|TWO_SIDED|95.0|-0.0441|0.2301|||Mixed Models Analysis|||Insula||0.2301|-0.0441|0.1806
71689713|NCT00237692|142895821|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|73.4|||||TWO_SIDED|95.0|66.1|80.7|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.||80.7|66.1|
71689714|NCT00237692|142895821|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|68.6|||||TWO_SIDED|95.0|60.5|76.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 12 months.||76.6|60.5|
71689715|NCT00237692|142895821|SUPERIORITY_OR_OTHER||% Diff|13.2|||||TWO_SIDED|95.0|2.0|24.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.||24.4|2.0|
71927207|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0491||||0.472|TWO_SIDED|95.0|-0.1846|0.0863|||Mixed Models Analysis|||Insula||0.0863|-0.1846|0.4720
71927208|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0011||||0.9842|TWO_SIDED|95.0|-0.1079|0.1058|||Mixed Models Analysis|||Medial frontal gyrus||0.1058|-0.1079|0.9842
71927209|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|0.0077||||0.8822|TWO_SIDED|95.0|-0.0949|0.1102|||Mixed Models Analysis|||Medial frontal gyrus||0.1102|-0.0949|0.8822
71927210|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0087||||0.8657|TWO_SIDED|95.0|-0.1111|0.0937|||Mixed Models Analysis|||Medial frontal gyrus||0.0937|-0.1111|0.8657
71927211|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|0.0043||||0.9599|TWO_SIDED|95.0|-0.165|0.1736|||Mixed Models Analysis|||Superior temporal gyrus||0.1736|-0.1650|0.9599
71927212|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|0.0489||||0.549|TWO_SIDED|95.0|-0.1129|0.2107|||Mixed Models Analysis|||Superior temporal gyrus||0.2107|-0.1129|0.5490
71927213|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0446||||0.5854|TWO_SIDED|95.0|-0.2068|0.1176|||Mixed Models Analysis|||Superior temporal gyrus||0.1176|-0.2068|0.5854
71927214|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0192||||0.7203|TWO_SIDED|95.0|-0.1259|0.0874|||Mixed Models Analysis|||Precentral gyrus||0.0874|-0.1259|0.7203
71927215|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|0.0404||||0.433|TWO_SIDED|95.0|-0.0617|0.1425|||Mixed Models Analysis|||Precentral gyrus||0.1425|-0.0617|0.4330
71927216|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0596||||0.2488|TWO_SIDED|95.0|-0.1619|0.0426|||Mixed Models Analysis|||Precentral gyrus||0.0426|-0.1619|0.2488
71927217|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.007||||0.8886|TWO_SIDED|95.0|-0.1059|0.0919|||Mixed Models Analysis|||Cingulate gyrus||0.0919|-0.1059|0.8886
71927218|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|0.0684||||0.1563|TWO_SIDED|95.0|-0.0267|0.1635|||Mixed Models Analysis|||Cingulate gyrus||0.1635|-0.0267|0.1563
71689716|NCT00237692|142895821|SUPERIORITY_OR_OTHER||% Diff|13.5|||||TWO_SIDED|95.0|2.4|24.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.||24.6|2.4|
71689717|NCT00237692|142895821|SUPERIORITY_OR_OTHER||% diff|8.6|||||TWO_SIDED|95.0|-2.9|20.2||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 12 months.||20.2|-2.9|
71689718|NCT00237692|142895822|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|61.8|||||TWO_SIDED|95.0|53.0|70.6|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 18 months||70.6|53.0|
71689719|NCT00237692|142895822|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|59.4|||||TWO_SIDED|95.0|50.8|67.9|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled BP at 18 months||67.9|50.8|
71689720|NCT00237692|142895822|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|63.5|||||TWO_SIDED|95.0|55.1|72.0|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months.||72.0|55.1|
71927219|NCT04311411|143375173|SUPERIORITY||Mean Difference (Final Values)|-0.0754||||0.1182|TWO_SIDED|95.0|-0.1704|0.0196|||Mixed Models Analysis|||Cingulate gyrus||0.0196|-0.1704|0.1182
71927220|NCT04311411|143375174|SUPERIORITY||Mean Difference (Final Values)|20.57|||<|0.0001|TWO_SIDED|95.0|12.11|29.02|||Mixed Models Analysis|||Fasting (Pre-lunch)||29.02|12.11|<.0001
71927221|NCT04311411|143375174|SUPERIORITY||Mean Difference (Final Values)|6.63||||0.1097|TWO_SIDED|95.0|-1.53|14.79||Fasting|Mixed Models Analysis|||Fasting (Pre-lunch)||14.79|-1.53|0.1097
71927222|NCT04311411|143375174|SUPERIORITY||Mean Difference (Final Values)|13.94||||0.0015|TWO_SIDED|95.0|5.49|22.38|||Mixed Models Analysis|||Fasting (Pre-lunch)||22.38|5.49|0.0015
71927223|NCT04311411|143375174|SUPERIORITY||Mean Difference (Final Values)|2.25||||0.4469|TWO_SIDED|95.0|-3.6|8.09|||Mixed Models Analysis|||Postprandial (Post-lunch)||8.09|-3.60|0.4469
71927224|NCT04311411|143375174|SUPERIORITY||Mean Difference (Final Values)|0.64||||0.8227|TWO_SIDED|95.0|-5.02|6.31|||Mixed Models Analysis|||Postprandial (Post-lunch)||6.31|-5.02|0.8227
71927225|NCT04311411|143375174|SUPERIORITY||Mean Difference (Final Values)|1.61||||0.5861|TWO_SIDED|95.0|-4.23|7.45|||Mixed Models Analysis|||Postprandial (Post-lunch)||7.45|-4.23|0.5861
71927226|NCT01817764|143375179|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.074|||<|0.001|TWO_SIDED|95.0|0.038|0.11|||ANCOVA|||||0.110|0.038|<0.001
71927227|NCT04888377|143375181|NON_INFERIORITY|The primary hypothesis of non-inferiority was tested by calculating the mean difference between treatment arms and its associated 90% confidence interval for the primary outcome. If the lower bound of the 90% confidence interval was greater than -4, then LDA was assumed to be non-inferior to placebo. If non-inferiority were assumed, a one-sided t-test would test the benefit of LDA compared to placebo. All models controlled for site as the original randomization stratification factor.|Mean Difference (Final Values)|-0.8||||0.25|TWO_SIDED|95.0|-2.2|0.6||For each outcome, the adjusted mean difference between treatment groups and the associated 95% confidence interval based on an ANCOVA model is presented.|ANCOVA||Mean difference is Aspirin-Placebo.|Assuming a non-inferiority margin of 4 points in the BSID-III cognitive score as clinically significant, and a true effect of LDA of not more than a 1 point decrease, a total sample size of 620 was determined to provide 80% power for a one-sided test for non-inferiority with a type I error of 5%. To test this secondary hypothesis, the sample size also provided over 90% power, at a two-sided type I error of 5%, to detect a difference of 4 points between LDA and placebo based on a two-sided test.||0.6|-2.2|0.25
71927228|NCT00526162|143375200|OTHER||percentage|0.0|||<|0.03|ONE_SIDED|97.0||||Using a confidence interval of 97%, the exact binomial upper confidence bound was 9.5% which is lower than the 10% set for the primary safety objective. Therefore, the actual p-value has not been calculated further.|One proportion binomial exact||The confidence interval was calculated based on 35 patients who completed 1-month follow-up at interim analysis.|||||<0.03
71927229|NCT05644756|143375219|OTHER|The primary analysis examined changes in measurement-based care (MBC) collection over time using ANOVA. The study was not designed as a superiority, non-inferiority, or equivalence trial.|||||>|0.01|||||||ANOVA|||||||>.01
71927230|NCT03985982|143375220|SUPERIORITY||||||<|0.001||||||This outcome measure is the first to be assessed in a hierarchical testing sequence using a one-sided alpha of 0.025.|Cochran-Mantel-Haenszel|||||||<0.001
71927231|NCT03985982|143375221|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the second test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous test shows statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Emotional domain - Change from Baseline at Week 4||||<0.001
71927232|NCT03985982|143375221|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the third test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous two tests show statistical significance at the alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Social Functioning domain - Change from Baseline at Week 4||||<0.001
71927233|NCT03985982|143375221|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the forth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous three tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for Modified Skindex-16 (GL-QoL) Overall score - Change from Baseline at Week 4.||||<0.001
71927234|NCT03985982|143375221|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the fifth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous four tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Appraisal of Lines Between Eyebrows - Change from Baseline at Week 4||||<0.001
71927235|NCT03985982|143375221|SUPERIORITY||||||<|0.001||||||The statistical significance is set to 0.025. This is the sixth test in a hierarchical testing sequence. Statistical significance will only be assessed if the previous five tests show statistical significance at the 1-sided alpha level of 0.025.|Wilcoxon (Mann-Whitney)|||Test performed for FACE-Q Age Appraisal VAS score||||<0.001
71927236|NCT00617175|143375269|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Negative binomial regression|||||||<0.001
71927237|NCT03586427|143375271|OTHER|Mixed model of repeated measures least square estimates of change compared to placebo|||||>|0.05||||||Comparison of each dose level change from baseline to placebo baseline yielded P values \>0.05|Mixed Models Analysis|||Each dose group was compared to placebo||||>0.05
71927238|NCT00423137|143375284|OTHER||Difference of least square means|-1.385|STANDARD_ERROR_OF_MEAN|2.181||0.5305|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.||||||0.5305
71689721|NCT00237692|142895822|SUPERIORITY_OR_OTHER||Est. % of Patients with controlled SBP|71.6|||||TWO_SIDED|95.0|63.7|79.5|||||Joint National Committee 7 blood pressure control: \< 140/90 mmHg for non-diabetics; \<130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months||79.5|63.7|
71689722|NCT00237692|142895822|SUPERIORITY_OR_OTHER||% Diff|-2.4|||||TWO_SIDED|95.0|-14.6|9.7||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.||9.7|-14.6|
71689723|NCT00237692|142895822|SUPERIORITY_OR_OTHER||% Diff|1.7|||||TWO_SIDED|95.0|-10.3|13.8||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.||13.8|-10.3|
71927239|NCT00423137|143375285|OTHER||Difference of least square means|-0.049|STANDARD_ERROR_OF_MEAN|0.033||0.1498|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1498
71927240|NCT00423137|143375288|OTHER||Difference of least square means|0.335|STANDARD_ERROR_OF_MEAN|0.434||0.4472|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4472
71927241|NCT00423137|143375289|OTHER||Difference of least square means|-0.141|STANDARD_ERROR_OF_MEAN|0.342||0.6829|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.6829
71927242|NCT00423137|143375290|OTHER||Difference of least square means|0.571|STANDARD_ERROR_OF_MEAN|0.391||0.1565|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.1565
71927243|NCT00423137|143375291|OTHER||Difference of least square means|1.081|STANDARD_ERROR_OF_MEAN|1.185||0.3709|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.3709
71927244|NCT00423137|143375292|OTHER||Difference of least square means|-52.083|STANDARD_ERROR_OF_MEAN|16.48||0.0044|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0044
71927245|NCT00423137|143375293|OTHER||Difference of least square means|-67.012|STANDARD_ERROR_OF_MEAN|21.29||0.0056|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0056
71927246|NCT00423137|143375294|OTHER||Difference of least square means|-62.571|STANDARD_ERROR_OF_MEAN|18.42||0.0025|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0025
71927247|NCT00423137|143375295|OTHER||Difference of least square means|-40.067|STANDARD_ERROR_OF_MEAN|18.8||0.0439|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0439
71927248|NCT00423137|143375296|OTHER||Difference of least square means|-57.46|STANDARD_ERROR_OF_MEAN|21.3||0.0129|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0129
71927249|NCT00423137|143375297|OTHER||Difference of least square means|-55.332|STANDARD_ERROR_OF_MEAN|17.11||0.0037|||||||ANCOVA|The adjusted least squares mean is estimated based on the one way ANOVA model with Treatment.|Difference to Placebo \[Treatment-Placebo\]|||||0.0037
71927250|NCT00423137|143375298|OTHER||Difference of least square means|0.0|STANDARD_ERROR_OF_MEAN|0.001||0.9076|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.9076
71927251|NCT00423137|143375299|OTHER||Difference of least square means|-13453.0|STANDARD_ERROR_OF_MEAN|16118.0||0.4121|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.4121
71927252|NCT00423137|143375300|OTHER||Difference of least square means|-78.619|STANDARD_ERROR_OF_MEAN|298.91||0.7948|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.7948
71689724|NCT00237692|142895822|SUPERIORITY_OR_OTHER||% Diff|9.8|||||TWO_SIDED|95.0|-1.9|21.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral \& Med Mgmt and Arm 1 - Control at 18 months.||21.4|-1.9|
71689725|NCT00237692|142895824|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|2.0|||||TWO_SIDED|95.0|-3.1|7.1|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||7.1|-3.1|
71689726|NCT00237692|142895824|SUPERIORITY_OR_OTHER||Est. Dif in Patient w/Controlled DBP|0.5|||||TWO_SIDED|95.0|-2.7|3.8|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral||3.8|-2.7|
71927253|NCT00423137|143375301|OTHER||Difference of least square means|0.195|STANDARD_ERROR_OF_MEAN|0.101||0.064|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0640
71927254|NCT00423137|143375302|OTHER||Difference of least square means|0.007|STANDARD_ERROR_OF_MEAN|0.004||0.0587|||||||ANCOVA|The adjusted least squares mean is estimated based on the ANCOVA model with treatment, centre, and baseline.|Difference to Placebo \[Treatment-Placebo\]|||||0.0587
71927255|NCT00593385|143375320|OTHER||Meta-Analysis|9.67||||0.005|ONE_SIDED|95.0||16.57||An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.|Exact test of the binomial distribution||To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%|The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.||16.57||0.005
71927256|NCT01797458|143375355|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02||||||Twenty-five teeth experienced at least one 'Minor' failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%).|Kruskal-Wallis|||The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.||||0.02
71927257|NCT00924313|143375370|SUPERIORITY||||||<|0.0001||||||The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.|Spearman rank correlation|||||||<0.0001
71927258|NCT00924313|143375370|SUPERIORITY|||||||0.65||||||The reported p-value is representative of the BPH high uptake level.|Spearman rank correlation|||||||0.65
71927259|NCT00924313|143375373|SUPERIORITY|||||||0.55|||||||Spearman rank correlation|||||||0.55
71927260|NCT00924313|143375375|SUPERIORITY|||||||0.407|||||||Spearman rank correlation|||||||0.407
71927261|NCT00491322|143375378|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71927262|NCT00602667|143375388|OTHER||Hazard Ratio (HR)|4.99|||||TWO_SIDED|95.0|1.17|21.23||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||21.23|1.17|
71927263|NCT00602667|143375388|OTHER||Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.4|1.84||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.84|0.40|
71927264|NCT00602667|143375389|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|0.42|8.22||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).||8.22|0.42|
71761223|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.6|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.||-0.8|-1.6|<0.0001
71927265|NCT00602667|143375389|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.31|1.79||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).||1.79|0.31|
71927266|NCT04410978|143375477|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.061||||0.6691|TWO_SIDED|95.0|0.808|1.393||Threshold for significance at 2-sided 0.05 level.|Chi-squared|||Analysis was performed using negative binomial model with number of adjudicated relapses onset between randomization date and EOS date as the response variable, treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (\<4, \>=4) and geographic region (United States \[US\], non-US) as covariates, and log transformed observation duration as the offset variable.||1.393|0.808|0.6691
71927267|NCT04410978|143375478|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.85||||0.4888|TWO_SIDED|95.0|0.565|1.278||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.278|0.565|0.4888
71927268|NCT04410978|143375479|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.819||||0.2991|TWO_SIDED|95.0|0.582|1.151||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.151|0.582|0.2991
71927269|NCT04410978|143375480|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.084||||0.4575|TWO_SIDED|95.0|0.876|1.342|||Chi-squared|||Analysis was performed using negative binomial model with the number of new and/or enlarging T2-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, baseline T2-hyperintense lesion count, EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed observation duration as the offset variable.||1.342|0.876|0.4575
71927270|NCT04410978|143375481|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Relative risk|1.86||||0.0001|TWO_SIDED|95.0|1.358|2.548|||Chi-squared|||Analysis was performed using negative binomial model with the number of new Gd-enhancing T1-hyperintense lesions between randomization date and EOS date as the response variable, treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4) and geographic region (US, non-US) as covariates, and log transformed number of MRI scans as the offset variable.||2.548|1.358|0.0001
71689727|NCT00237692|142895824|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|0.4|||||TWO_SIDED|95.0|-4.8|5.5|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.||5.5|-4.8|
71689728|NCT00237692|142895824|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|0.7|||||TWO_SIDED|95.0|-2.6|4.0|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management||4.0|-2.6|
71689729|NCT00237692|142895824|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled SBP|1.6|||||TWO_SIDED|95.0|-3.3|6.6|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|-3.3|
71689730|NCT00237692|142895824|SUPERIORITY_OR_OTHER||Est. % Diff in Patient w/Controlled DBP|3.4|||||TWO_SIDED|95.0|0.3|6.6|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management||6.6|0.3|
71689731|NCT00685360|142895832|SUPERIORITY||Risk Ratio Mean|1.534|||=|0.0083|TWO_SIDED|95.0|1.107|2.124|||Cochran-Mantel-Haenszel|P-value was derived using Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata (cavitation).||||2.124|1.107|=0.0083
71689732|NCT00685360|142895832|SUPERIORITY||Risk Ratio Mean|1.416|||=|0.0393|TWO_SIDED|95.0|1.012|1.98||P-value was derived using CMH test stratified by randomization strata (cavitation).|Cochran-Mantel-Haenszel|||||1.980|1.012|=0.0393
71689733|NCT00685360|142895844|SUPERIORITY||Risk Ratio Mean|1.599|||=|0.0021|TWO_SIDED|95.0|1.175|2.177|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||2.177|1.175|=0.0021
71927271|NCT04410978|143375482|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Least square (LS) mean difference|0.035||||0.432|TWO_SIDED|95.0|-0.053|0.124|||MMRM|||Covariates in the mixed-effect model with repeated measures (MMRM) were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||0.124|-0.053|0.4320
71927272|NCT04410978|143375483|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|1.873||||0.0675|TWO_SIDED|95.0|-0.135|3.88|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, baseline value, and baseline value-by-visit interaction.||3.880|-0.135|0.0675
71927273|NCT04410978|143375484|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|Hazard Ratio (HR)|0.831||||0.3594|TWO_SIDED|95.0|0.554|1.245||Derived from log-rank test with stratification of EDSS strata (\<4, \>=4), geographic region (US, non-US).|Log Rank|||Analysis was performed using Cox proportional-hazards model with robust variance estimation. Covariates were treatment group, Gd-enhancing T1 lesions at baseline (presence, absence), EDSS strata (\<4, \>=4), geographic region (US, non-US).||1.245|0.554|0.3594
71927274|NCT04410978|143375485|SUPERIORITY|A hierarchical testing procedure was used to control the overall type I error.|LS mean difference|0.196||||0.0002|TWO_SIDED|95.0|0.093|0.298|||MMRM|||Covariates in the MMRM were treatment group, EDSS strata (\<4, \>=4), geographic region (US, non-US), visit, treatment by visit interaction, cube root transformed Month 6 brain volume, and cube root transformed Month 6 brain volume-by-visit interaction.||0.298|0.093|0.0002
71689734|NCT00685360|142895844|SUPERIORITY||Risk Ratio Mean|1.939|||<|0.0001|TWO_SIDED|95.0|1.449|2.595|||Cochran-Mantel-Haenszel|||||2.595|1.449|<.0001
71689735|NCT00685360|142895845|SUPERIORITY||||||=|0.2419|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from analysis of covariance(ANCOVA)model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2419
71689736|NCT00685360|142895845|SUPERIORITY||||||=|0.2239|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.2239
71689737|NCT00685360|142895845|SUPERIORITY||||||=|0.9544|TWO_SIDED||||||ANCOVA|Pairwise comparison is derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.9544
71689738|NCT00685360|142895846|SUPERIORITY||||||=|0.0246|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0246
71689739|NCT00685360|142895846|SUPERIORITY||||||=|0.0529|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.0529
71689740|NCT00685360|142895846|SUPERIORITY||||||=|0.7508|TWO_SIDED||||||ANCOVA|Pairwise comparison was derived from ANCOVA model with factors of treatment, baseline cavitation status and covariate baseline.||||||=0.7508
71689741|NCT00685360|142895847|SUPERIORITY||Risk Ratio Mean|1.272|||=|0.0518|TWO_SIDED|95.0|0.995|1.627|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.627|0.995|=0.0518
71689742|NCT00685360|142895847|SUPERIORITY||Risk Ratio Mean|1.203|||=|0.1506|TWO_SIDED|95.0|0.934|1.55|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.550|0.934|=0.1506
71689743|NCT00685360|142895848|SUPERIORITY||Risk Ratio Mean|1.234|||=|0.1201|TWO_SIDED|95.0|0.945|1.612|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.612|0.945|=0.1201
71689744|NCT00685360|142895848|SUPERIORITY||Risk Ratio Mean|1.099|||=|0.5112|TWO_SIDED|95.0|0.829|1.456|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.456|0.829|=0.5112
71927275|NCT04115488|143375495|EQUIVALENCE|Data was analyzed using a negative binomial model with a logarithmic link function and fixed effects for the treatment group and stratification factors. Equivalence was tested based 95% confidence interval.|Exponentiated Difference|0.17|STANDARD_ERROR_OF_MEAN|0.397|||TWO_SIDED|95.0|-0.613|0.944|||||Difference calculated as Tysabri minus PB006.|||0.944|-0.613|
71927276|NCT03315780|143375562|SUPERIORITY||Mean Difference (Final Values)|-254.02|||<|0.0001|TWO_SIDED|95.0|-337.76|-170.28|||Mixed Models Analysis|||||-170.28|-337.76|< 0.0001
71927277|NCT03315780|143375565|SUPERIORITY||Mean Difference (Final Values)|27.46||||0.01|TWO_SIDED|95.0|8.05|46.87|||Mixed Models Analysis|||||46.87|8.05|0.0100
71927278|NCT03315780|143375566|SUPERIORITY||Mean Difference (Final Values)|3.72||||0.0263|TWO_SIDED|95.0|0.63|6.81|||Mixed Models Analysis|||||6.81|0.63|0.0263
71689745|NCT00685360|142895849|SUPERIORITY||Risk Ratio Mean|1.323|||=|0.0141|TWO_SIDED|95.0|1.053|1.661|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.661|1.053|=0.0141
71689746|NCT00685360|142895849|SUPERIORITY||Risk Ratio Mean|1.438|||=|0.0008|TWO_SIDED|95.0|1.155|1.791|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.791|1.155|=0.0008
71927279|NCT03315780|143375567|SUPERIORITY||Mean Difference (Final Values)|-9.36||||0.08|TWO_SIDED|95.0|-20.16|1.43|||Mixed Models Analysis|||||1.43|-20.16|0.0800
71927280|NCT03315780|143375568|SUPERIORITY||Mean Difference (Final Values)|-15.39||||0.7475|TWO_SIDED|95.0|-118.35|87.57|||Mixed Models Analysis|||||87.57|-118.35|0.7475
71927281|NCT01361308|143375570|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA|||||||<0.0001
71927282|NCT01361308|143375570|SUPERIORITY_OR_OTHER|||||||0.009||||||Week 12 frequency|Rank transformed ANCOVA|||||||0.0090
71927283|NCT01361308|143375571|SUPERIORITY_OR_OTHER|||||||0.001||||||Clinical meaningfulness at week 4|Logit model|||||||0.001
71927284|NCT01361308|143375571|SUPERIORITY_OR_OTHER|||||||0.055||||||Clinical meaningfulness at week 12|Logit model|||||||0.055
71927285|NCT01361308|143375587|SUPERIORITY_OR_OTHER|||||||0.0017||||||Week 4 severity|Rank transformed ANCOVA|||||||0.0017
71927286|NCT01361308|143375587|SUPERIORITY_OR_OTHER|||||||0.1658||||||Week 12 severity|Rank transformed ANCOVA|||||||0.1658
71927287|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|5.96|||<|0.001|TWO_SIDED|95.0|4.0|9.18||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||9.18|4.00|<.001
71927288|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|5.02|||<|0.001|TWO_SIDED|95.0|3.36|7.76||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||7.76|3.36|<.001
71927289|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|3.3|||<|0.001|TWO_SIDED|95.0|2.17|5.17||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who previously enrolled in the program).||5.17|2.17|<.001
71927290|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|3.28||||0.038|TWO_SIDED|95.0|1.16|11.71||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||11.71|1.16|.038
71927291|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|2.01||||0.256|TWO_SIDED|95.0|0.63|7.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||7.54|0.63|.256
71927292|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|1.5||||0.531|TWO_SIDED|95.0|0.43|5.89||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the three email conditions as dummy variables with no email as the reference group (among employees who never enrolled in the program).||5.89|0.43|.531
71927293|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|1.19||||0.202|TWO_SIDED|95.0|0.91|1.54||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||1.54|0.91|.202
71927294|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|0.66||||0.005|TWO_SIDED|95.0|0.49|0.88||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled in the program).||0.88|0.49|.005
71927295|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|0.75||||0.276|TWO_SIDED|95.0|0.69|4.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||4.16|0.69|.276
71927296|NCT03965754|143375602|SUPERIORITY||Odds Ratio (OR)|0.75||||0.592|TWO_SIDED|95.0|0.25|2.16||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled in the program).||2.16|0.25|.592
71927297|NCT03965754|143375603|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).|Odds Ratio (OR)|1.31||||0.02|TWO_SIDED|95.0|1.04|1.65||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.65|1.04|.020
71927298|NCT03965754|143375603|SUPERIORITY||Odds Ratio (OR)|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.75||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who previously enrolled).||0.75|0.44|<.001
71927299|NCT03965754|143375603|SUPERIORITY||Odds Ratio (OR)|0.75||||0.359|TWO_SIDED|95.0|0.41|1.38||We used an a priori threshold of p \< .05.|Regression, Logistic|||We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).||1.38|0.41|.359
71927300|NCT03965754|143375603|SUPERIORITY|We conducted a logistic regression with the two experimental conditions as dummy variables with the standard email as the reference group (among employees who never enrolled).|Odds Ratio (OR)|1.72||||0.035|TWO_SIDED|95.0|1.05|2.9|||Regression, Logistic|We used an a priori threshold of p \< .05.||||2.90|1.05|.035
71927301|NCT02983305|143375604|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area at baseline.||||.0001
71927302|NCT02983305|143375604|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.0001||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area under intervention conditions.||||0.0001
71927303|NCT02983305|143375604|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.003||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.||||.003
71927304|NCT02983305|143375605|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.38||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed at baseline.||||0.38
71927305|NCT02983305|143375605|EQUIVALENCE|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.27||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed under intervention conditions.||||0.27
71927306|NCT02983305|143375605|EQUIVALENCE|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.79||||||P \< .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the gait speed detected between baseline and intervention.||||0.79
71927307|NCT01646268|143375606|SUPERIORITY_OR_OTHER||LS Means|-4.82|STANDARD_ERROR_OF_MEAN|1.2|<|0.0001|TWO_SIDED|95.0|-7.18|-2.45|||ANCOVA||Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.|The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).||-2.45|-7.18|<0.0001
71927308|NCT00461591|143375616|SUPERIORITY||Odds Ratio (OR)|0.76||||0.1068|TWO_SIDED|95.0|0.54|1.06|||Cochran-Mantel-Haenszel|||||1.06|0.54|0.1068
71927309|NCT00461591|143375617|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0412|TWO_SIDED|95.0|0.59|0.99|||Log Rank|||||0.99|0.59|0.0412
71927310|NCT02325414|143375637|SUPERIORITY||Median Difference (Final Values)|10.61||||0.05|TWO_SIDED||||||Mixed Models Analysis||||One-year data analysis were carried out using linear mixed-effects models. Covariate adjustments for baseline value of the corresponding outcome and ambulatory status (measured by WISCI) were performed by fitting these variables as fixed factors. The repeated measures were addressed using participant identification as random intercepts in the model.|||0.05
71927311|NCT02544607|143375641|OTHER||||||<|0.01|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.01
71927312|NCT02544607|143375642|OTHER|||||||0.048|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.048
71927313|NCT02544607|143375643|OTHER|||||||0.003|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.003
71927314|NCT02544607|143375644|OTHER|||||||0.0499|TWO_SIDED|95.0|||||t-test, 2 sided|||||||.0499
71927315|NCT02544607|143375645|OTHER|||||||0.038|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.038
71927316|NCT00347776|143375679|SUPERIORITY||Cox Proportional Hazard|0.67||||0.047|TWO_SIDED|95.0|0.45|0.98|||Log Rank|||"The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.~The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence."||0.98|0.45|.047
71927317|NCT00347776|143375680|SUPERIORITY|||||||0.19|||||||Log Rank|||"We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.~The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years."||||0.19
71927318|NCT00347776|143375681|SUPERIORITY||Odds Ratio (OR)|0.63|||||TWO_SIDED|95.0|0.36|1.1|||Regression, Logistic||Comparison group was the tetracycline group.|Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.||1.10|0.36|
71927319|NCT00518531|143375683|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|10.5||||0.0259|TWO_SIDED|95.0|1.3|19.7||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||19.7|1.3|0.0259
71927320|NCT00518531|143375684|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|30.9|||<|0.0001|TWO_SIDED|95.0|20.6|41.3||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.|||41.3|20.6|<0.0001
71927321|NCT00518531|143375685|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|11.0||||0.0138|TWO_SIDED|95.0|2.2|19.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||19.7|2.2|0.0138
71927322|NCT00518531|143375686|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.7|||<|0.0001|TWO_SIDED|95.0|17.6|37.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||37.7|17.6|<0.0001
71927323|NCT00518531|143375687|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|9.8||||0.0291|TWO_SIDED|95.0|1.1|18.5|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||18.5|1.1|0.0291
71927324|NCT00518531|143375688|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|27.4|||<|0.0001|TWO_SIDED|95.0|18.1|36.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.|||36.7|18.1|<0.0001
71927325|NCT03681769|143375704|EQUIVALENCE|Non-equivalence determined by p\<.05.||||||0.83||||||No site X time interaction (F12,270 = 0.614, p = 0.830).|Mixed Models Analysis|||||||.83
71927326|NCT03681769|143375705|OTHER|||||||0.53|||||||t-test, 2 sided|||||||.53
71927327|NCT03722849|143375741|OTHER||||||=|0.0028||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0028
71927328|NCT03722849|143375742|OTHER||||||=|0.007||||||No multiple comparisons as region of interest analysis defined a priori.|Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests for non-parametric data||||=0.0070
71927329|NCT03722849|143375743|OTHER|Group comparisons (Cough versus healthy) for each measurement using repeated measures ANOVA.|||||=|0.0019|||||||ANOVA|with repeated measures||||||=0.0019
71927330|NCT03722849|143375745|OTHER|Group-wise comparisons using unpaired t-tests or one way ANOVA|||||<|0.0001|||||||ANOVA|||||||<0.0001
71927331|NCT03478982|143375746|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
71927332|NCT03478982|143375746|SUPERIORITY||Difference in percentage|23.3|||=|0.0392|TWO_SIDED|95.0|1.8|44.8|||Chi-squared|||||44.8|1.8|=0.0392
71927333|NCT00659945|143375754|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||The primary endpoint was the incidence of emesis at any time within the first 48 hours after surgery. Power analysis showed that a sample size of 69 patients per group was necessary to detect a significant decrease in the incidence of emesis from 33% in the placebo group to 15% in the aprepitant group using a Chi-square test with an alpha value of 0.05 and power of 80%.||||<0.05
71927334|NCT04259905|143375811|SUPERIORITY||Cohen's d|0.85|||||TWO_SIDED|||||||||||||
71927335|NCT04259905|143375812|SUPERIORITY||Cohen's d|1.29|||||TWO_SIDED|||||||||||||
71927336|NCT04259905|143375813|SUPERIORITY||Cohen's d|1.06|||||TWO_SIDED|||||||||||||
71927337|NCT00762073|143375834|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.239||||0.5282|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.5282
71927338|NCT00762073|143375834|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|18.86||||0.0092|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0092
71927339|NCT00762073|143375834|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|15.009||||0.0174|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.0174
71927340|NCT00762073|143375835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1786|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.1786
71927341|NCT00762073|143375835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0090
71927342|NCT00762073|143375835|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0001
71927343|NCT00762073|143375836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4959|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.4959
71927344|NCT00762073|143375836|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||0.0040
71927345|NCT00762073|143375836|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic|||||||<0.0001
71927346|NCT00762073|143375837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0108|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0108
71927347|NCT00762073|143375837|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0208|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.0208
71927348|NCT00762073|143375837|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||<0.0001
71927349|NCT00762073|143375838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1095|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.1095
71927350|NCT00762073|143375838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0264|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0264
71927351|NCT00762073|143375838|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA|||||||0.0010
71927352|NCT00762073|143375839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3769|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3769
71927353|NCT00762073|143375839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9363|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9363
71689747|NCT00685360|142895850|SUPERIORITY||Risk Ratio Mean|1.341|||=|0.0196|TWO_SIDED|95.0|1.044|1.722|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.722|1.044|=0.0196
71927354|NCT00762073|143375839|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1235|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.1235
71927355|NCT00762073|143375840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3444|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3444
71927356|NCT00762073|143375840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9258|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.9258
71927357|NCT00762073|143375840|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3215|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic|||||||0.3215
71927358|NCT00762073|143375841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6729|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.6729
71927359|NCT00762073|143375841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8894|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8894
71927360|NCT00762073|143375841|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1532|TWO_SIDED|||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.1532
71927361|NCT00762073|143375842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4197|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.4197
71927362|NCT00762073|143375842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9787|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.9787
71927363|NCT00762073|143375842|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8987|TWO_SIDED|||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA|||||||0.8987
71689748|NCT00685360|142895850|SUPERIORITY||Risk Ratio Mean|1.503|||=|0.0006|TWO_SIDED|95.0|1.183|1.909|||Cochran-Mantel-Haenszel|P-value was derived using CMH test stratified by randomization strata (cavitation).||||1.909|1.183|=0.0006
71689749|NCT00685360|142895851|SUPERIORITY||||||=|0.0468|||||||Cochran-Armitage Linear Trend Test|Cochran-Armitage test was performed for dose response with the treatment group ordered as placebo, delamanid 100 mg BID, and delamanid 200 mg BID.||||||=0.0468
71689750|NCT00685360|142895852|SUPERIORITY||Hazard Ratio (HR)|1.856|||=|0.0011|TWO_SIDED|95.0|1.255|2.745|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.745|1.255|=0.0011
71927364|NCT00326625|143375848|SUPERIORITY||Slope difference|-0.06|STANDARD_ERROR_OF_MEAN|0.083||0.4807|TWO_SIDED|95.0|-0.22|0.1|||ANCOVA||Glatiramer acetate vs. Placebo|Analysis compares the ALSFRS-R slopes of change from baseline between treatment groups. Analysis includes the following covariates: time from randomization, treatment group, time by treatment interaction, center, Riluzole use, age, site of ALS onset, time from ALS onset and baseline ALSFRS-R score.||0.10|-0.22|0.4807
71927365|NCT00326625|143375849|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8583|TWO_SIDED|95.0|0.56|2.005|||Regression, Cox||Glatiramer acetate vs. Placebo|Analysis covariates are center, riluzole use, site of ALS onset, time from ALS onset, baseline ALSFRS-R score, baseline slow vital capacity (VC) and baseline body mass index (BMI).||2.005|0.560|0.8583
71927366|NCT01265875|143375850|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 4.||||.25
71927367|NCT01265875|143375850|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to day 7.||||.19
71927368|NCT01265875|143375850|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.27
71927369|NCT01265875|143375852|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 4.||||.52
71927370|NCT01265875|143375852|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED||||||t-test, 2 sided|||Change from baseline to Day 30.||||.34
71927371|NCT04456998|143375860|SUPERIORITY||Mean Difference (Net)|-96.1||||0.031|TWO_SIDED|95.0|-183.5|-8.8|||ANCOVA||GB002 vs. Placebo|||-8.8|-183.5|0.0310
71927372|NCT04456998|143375861|SUPERIORITY||Mean Difference (Net)|6.5||||0.5972|TWO_SIDED|95.0|-17.9|30.9|||Mixed Models Analysis||GB002 vs. Placebo|||30.9|-17.9|0.5972
71927373|NCT03179462|143375901|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71927374|NCT05153629|143375903|OTHER|||||||0.93||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of back pain.||||0.93
71927375|NCT05153629|143375903|OTHER|||||||0.76||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of abdominal/groin pain.||||0.76
71927376|NCT05153629|143375903|OTHER|||||||0.56||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain frequency.||||0.56
71927377|NCT05153629|143375903|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of nausea intensity.||||0.26
71927378|NCT05153629|143375904|OTHER|||||||0.55||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in back pain.||||0.55
71927379|NCT05153629|143375904|OTHER|||||||0.28||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in abdominal/groin pain.||||0.28
71927380|NCT05153629|143375904|OTHER|||||||0.39||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in pain frequency.||||0.39
71927381|NCT05153629|143375904|OTHER|||||||0.26||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of difference in nausea intensity.||||0.26
71927382|NCT05153629|143375905|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
71927383|NCT05153629|143375906|OTHER|||||||0.5||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||||||0.50
71927384|NCT05153629|143375907|OTHER|||||||0.8||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall USDT score.||||0.80
71927385|NCT05153629|143375907|OTHER|||||||0.72||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of urinary symptoms.||||0.72
71927386|NCT05153629|143375907|OTHER|||||||0.45||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of pain.||||0.45
71927387|NCT05153629|143375907|OTHER|||||||0.42||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of daily life.||||0.42
71927388|NCT05153629|143375907|OTHER|||||||0.36||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of sexual life.||||0.36
71927389|NCT05153629|143375907|OTHER|||||||0.49||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of medical care/analgesic use.||||0.49
71927390|NCT05153629|143375907|OTHER|||||||0.88||||||A p-value less than the a priori threshold of 0.05 is considered statistically significant.|t-test, 2 sided|||Analysis of overall quality of life.||||0.88
71927391|NCT03743571|143375912|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
71927392|NCT03743571|143375913|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
71927393|NCT03743571|143375914|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
71927394|NCT03743571|143375915|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.42||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.67, p = 0.42.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.42
71927395|NCT03743571|143375916|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.88||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 0.02, p = .88.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.88
71927396|NCT03743571|143375917|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham), and whether scores differed between audience type (matched vs unmatched) for the two tDCS groups (anodal/active vs sham).||||||0.17||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,24) = 1.98, p = .17.||We used a null hypothesis significance testing approach in our analyses. For performance on Behavioral Approach Tests (BATs), we completed 2 x 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham), time (within subjects variable; baseline vs follow-up), and audience type (ethnicity primary matched vs unmatched to the participants' own identity) on outcome measures.||||.17
71927397|NCT03743571|143375918|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.67||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.19, p = .67||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.67
71927398|NCT03743571|143375919|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham).||||||0.96||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) \< .01, p = .96||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.96
71927399|NCT03743571|143375920|OTHER|We needed a total sample size of at least N = 24 to reach 80% power to detect a moderately large effect (Cohen's f = 0.3) for 2x2 interactions to determine whether scores differed across time (baseline vs follow up) for the two tDCS groups (anodal/active vs sham),||||||0.43||||||Unadjusted. A priori threshold was set at p \< .05, two-tailed|ANOVA|tDCS (anodal vs sham) x Time (baseline vs follow-up) interaction: F(1,26) = 0.65, p = .43||We used a null hypothesis significance testing approach in our analyses. For performance on the questionnaires, we completed 2 x 2 mixed factorial ANOVAs to evaluate the impact of tDCS groups (between-subjects variable; anodal/active vs sham) and time (within subjects variable; baseline vs follow-up) on outcome measures.||||.43
71927400|NCT01233284|143375926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.09|0.186|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.186|0.090|<0.0001
71927401|NCT01233284|143375926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.08|0.176|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.176|0.080|<0.0001
71927402|NCT01233284|143375926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.188|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.14|0.236|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.236|0.140|<0.0001
71927403|NCT01233284|143375927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.078|0.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.173|0.078|<0.0001
71927404|NCT01233284|143375927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.132|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.179|0.084|<0.0001
71927405|NCT01233284|143375927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001||95.0|0.096|0.191|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.191|0.096|<0.0001
71927406|NCT01233284|143375928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.129|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.083|0.175|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.175|0.083|<0.0001
71927407|NCT01233284|143375928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.081|0.172|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.172|0.081|<0.0001
71927408|NCT01233284|143375928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.178|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001||95.0|0.132|0.224|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.224|0.132|<0.0001
71927409|NCT01233284|143375929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.027||0.0034||95.0|0.026|0.132|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.132|0.026|0.0034
71927410|NCT01233284|143375929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.027||0.0087||95.0|0.018|0.124|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.124|0.018|0.0087
71927411|NCT01233284|143375929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.085|0.19|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.190|0.085|<0.0001
71927412|NCT01233284|143375930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.054|STANDARD_ERROR_OF_MEAN|0.03||0.0732||95.0|-0.005|0.113|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.113|-0.005|0.0732
71927413|NCT01233284|143375930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.03||0.0177||95.0|0.012|0.131|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.131|0.012|0.0177
71927414|NCT01233284|143375930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.098|STANDARD_ERROR_OF_MEAN|0.03||0.0012||95.0|0.039|0.157|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.157|0.039|0.0012
71927415|NCT01233284|143375931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064|STANDARD_ERROR_OF_MEAN|0.026||0.0149||95.0|0.013|0.115|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.115|0.013|0.0149
71927416|NCT01233284|143375931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.075|STANDARD_ERROR_OF_MEAN|0.026||0.0043||95.0|0.024|0.126|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.126|0.024|0.0043
71927417|NCT01233284|143375931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.138|STANDARD_ERROR_OF_MEAN|0.026|<|0.0001||95.0|0.086|0.189|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.189|0.086|<0.0001
71927418|NCT01233284|143375935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.55|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|11.204|25.895|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||25.895|11.204|<0.0001
71927419|NCT01233284|143375935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.895|STANDARD_ERROR_OF_MEAN|3.737|<|0.0001||95.0|10.55|25.24|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||25.240|10.550|<0.0001
71927420|NCT01233284|143375935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.846|STANDARD_ERROR_OF_MEAN|3.739|<|0.0001||95.0|13.497|28.195|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.195|13.497|<0.0001
71927421|NCT01233284|143375936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.251|STANDARD_ERROR_OF_MEAN|3.77|<|0.0001||95.0|13.84|28.662|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||28.662|13.840|<0.0001
71927422|NCT01233284|143375936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.577|STANDARD_ERROR_OF_MEAN|3.77||0.0001||95.0|7.166|21.988|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||21.988|7.166|0.0001
71927423|NCT01233284|143375936|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.581|STANDARD_ERROR_OF_MEAN|3.773|<|0.0001||95.0|14.166|28.997|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||28.997|14.166|<0.0001
71927424|NCT01233284|143375937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.635||0.8574||95.0|-1.363|1.134|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||1.134|-1.363|0.8574
71927425|NCT01233284|143375937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.635||0.3954||95.0|-1.789|0.708|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.708|-1.789|0.3954
71927426|NCT01233284|143375937|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.077|STANDARD_ERROR_OF_MEAN|0.636||0.9034||95.0|-1.327|1.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||1.173|-1.327|0.9034
71927427|NCT01233284|143375938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.233|STANDARD_ERROR_OF_MEAN|0.107||0.0296||95.0|-0.443|-0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.023|-0.443|0.0296
71927428|NCT01233284|143375938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.214|STANDARD_ERROR_OF_MEAN|0.107||0.0454||95.0|-0.424|-0.004|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.004|-0.424|0.0454
71927429|NCT01233284|143375938|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.201|STANDARD_ERROR_OF_MEAN|0.107||0.061||95.0|-0.41|0.009|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.009|-0.410|0.0610
71927430|NCT01233284|143375939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.149|STANDARD_ERROR_OF_MEAN|0.063||0.0183||95.0|-0.273|-0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||-0.025|-0.273|0.0183
71927431|NCT01233284|143375939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.138|STANDARD_ERROR_OF_MEAN|0.063||0.0288||95.0|-0.262|-0.014|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||-0.014|-0.262|0.0288
71927432|NCT01233284|143375939|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.111|STANDARD_ERROR_OF_MEAN|0.063||0.0781||95.0|-0.235|0.013|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.013|-0.235|0.0781
71927433|NCT01233284|143375940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.084|STANDARD_ERROR_OF_MEAN|0.055||0.1303||95.0|-0.193|0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.025|-0.193|0.1303
71927434|NCT01233284|143375940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.068|STANDARD_ERROR_OF_MEAN|0.055||0.2191||95.0|-0.177|0.041|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.041|-0.177|0.2191
71927435|NCT01233284|143375940|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.087|STANDARD_ERROR_OF_MEAN|0.056||0.1163||95.0|-0.196|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.022|-0.196|0.1163
71927436|NCT01233284|143375941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.032||0.7501||95.0|-0.073|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|||0.052|-0.073|0.7501
71927437|NCT01233284|143375941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.006|STANDARD_ERROR_OF_MEAN|0.032||0.8401||95.0|-0.069|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|||0.056|-0.069|0.8401
71927438|NCT01233284|143375941|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.031|STANDARD_ERROR_OF_MEAN|0.032||0.3237||95.0|-0.094|0.031|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|||0.031|-0.094|0.3237
71927439|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.079||0.1402|TWO_SIDED|95.0|-0.04|0.276||MMRM, adjusted for treatment, period, patient and study baseline.|Mixed Models Analysis||Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.276|-0.040|0.1402
71927440|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.079||0.0656|TWO_SIDED|95.0|-0.01|0.305|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.305|-0.010|0.0656
71927441|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.079||0.0766|TWO_SIDED|95.0|-0.015|0.299|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.299|-0.015|0.0766
71927442|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.081|STANDARD_ERROR_OF_MEAN|0.084||0.3371|TWO_SIDED|95.0|-0.086|0.249|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.249|-0.086|0.3371
71927443|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.084||0.1097|TWO_SIDED|95.0|-0.031|0.303|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.303|-0.031|0.1097
71927444|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.196|STANDARD_ERROR_OF_MEAN|0.084||0.022|TWO_SIDED|95.0|0.029|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.363|0.029|0.0220
71689751|NCT00685360|142895852|SUPERIORITY||Hazard Ratio (HR)|1.849|||=|0.0013|TWO_SIDED|95.0|1.246|2.743|||Stratified Log-Rank Test|p-value was derived from log-rank test with SAS Proc lifetest for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.743|1.246|=0.0013
71689752|NCT00685360|142895853|SUPERIORITY||Hazard Ratio (HR)|1.926|||=|0.0004|TWO_SIDED|95.0|1.315|2.82|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.820|1.315|=0.0004
71927445|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.078||0.2062|TWO_SIDED|95.0|-0.056|0.256|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.256|-0.056|0.2062
71927446|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.078||0.0731|TWO_SIDED|95.0|-0.014|0.297|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.297|-0.014|0.0731
71927447|NCT01233284|143375942|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.078||0.0333|TWO_SIDED|95.0|0.014|0.324|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.324|0.014|0.0333
71927448|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.099||0.2451|TWO_SIDED|95.0|-0.081|0.312|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.312|-0.081|0.2451
71927449|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.099||0.0379|TWO_SIDED|95.0|0.012|0.405|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.405|0.012|0.0379
71927450|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.167|STANDARD_ERROR_OF_MEAN|0.099||0.0957|TWO_SIDED|95.0|-0.03|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h||0.363|-0.030|0.0957
71927451|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.067|STANDARD_ERROR_OF_MEAN|0.104||0.5207|TWO_SIDED|95.0|-0.139|0.273|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.273|-0.139|0.5207
71927452|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.104||0.0606|TWO_SIDED|95.0|-0.009|0.404|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.404|-0.009|0.0606
71927453|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.181|STANDARD_ERROR_OF_MEAN|0.104||0.0855|TWO_SIDED|95.0|-0.026|0.387|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h||0.387|-0.026|0.0855
71927454|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.091|STANDARD_ERROR_OF_MEAN|0.099||0.3564|TWO_SIDED|95.0|-0.104|0.287|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.287|-0.104|0.3564
71927455|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.099||0.0424|TWO_SIDED|95.0|0.007|0.399|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.399|0.007|0.0424
71927456|NCT01233284|143375943|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.099||0.0815|TWO_SIDED|95.0|-0.022|0.37|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h||0.370|-0.022|0.0815
71927457|NCT01821391|143375972|SUPERIORITY||||||=|0.2665|||||||Paired Student's t test|||||||=0.2665
71927458|NCT04880850|143376034|NON_INFERIORITY|Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec minus insulin glargine) was strictly below 0.3%.|Treatment difference|0.02|||<|0.0001|TWO_SIDED|95.0|-0.11|0.15|||ANCOVA|||The response and change from baseline in response after 26 weeks were analysed using an analysis of covariance (ANCOVA) model with treatment, region and personal continuous glucose monitoring (CGM) device use as fixed factors, and baseline response as covariate.||0.15|-0.11|<0.0001
71927459|NCT03417102|143376045|SUPERIORITY||ABR ratio|0.092|||<|0.0001|TWO_SIDED|95.0|0.044|0.192||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.192|0.044|<0.0001
71927460|NCT03417102|143376047|SUPERIORITY||ABR ratio|0.108|||<|0.0001|TWO_SIDED|95.0|0.056|0.207||P-value derived from NB regression model, accounted for different follow-up times during TP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.207|0.056|<0.0001
71927461|NCT03417102|143376049|SUPERIORITY||ABR ratio|0.056|||<|0.0001|TWO_SIDED|95.0|0.026|0.121||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.121|0.026|<0.0001
71927462|NCT03417102|143376051|SUPERIORITY||ABR ratio|0.098|||<|0.0001|TWO_SIDED|95.0|0.046|0.21||P-value derived from NB regression model, accounted for different follow-up times during EP, with treatment arm and randomization strata of number of bleeds in 6 months prior to study (\<=10,\>10) as fixed effects. Significance threshold was 0.05.|Negative binomial regression model|||||0.210|0.046|<0.0001
71927463|NCT03417102|143376053|SUPERIORITY||Least Square (LS) Mean difference|-28.72|||<|0.0001|TWO_SIDED|95.0|-39.07|-18.37||Analysis of Covariance (ANCOVA) model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-18.37|-39.07|<0.0001
71689753|NCT00685360|142895853|SUPERIORITY||Hazard Ratio (HR)|2.19|||<|0.0001|TWO_SIDED|95.0|1.504|3.189|||Stratified Log-Rank Test|||||3.189|1.504|<.0001
71689754|NCT00685360|142895854|SUPERIORITY||Hazard Ratio (HR)|1.727|||=|0.0056|TWO_SIDED|95.0|1.152|2.591|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.591|1.152|=0.0056
71927464|NCT03417102|143376054|SUPERIORITY||LS Mean difference|-14.85|||<|0.0001|TWO_SIDED|95.0|-21.37|-8.33||ANCOVA model included treatment arm and randomization strata of number of bleeds (\<=10, \> 10) as fixed effects, Baseline score as a covariate. Significance threshold was at 0.05.|ANCOVA|||||-8.33|-21.37|<0.0001
71927465|NCT02062385|143376057|SUPERIORITY_OR_OTHER||1 - (Incidence V260 / Incidence Placebo)|69.3|||<|0.001|TWO_SIDED|95.0|54.5|79.7|||Clopper-Pearson|To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.||V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is \>0% at the final analysis||79.7|54.5|<0.001
71927466|NCT00706901|143376068|NON_INFERIORITY_OR_EQUIVALENCE|Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
71927467|NCT00706901|143376068|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||zero-hurdle Poisson model|||||||0.02
71927468|NCT00706901|143376069|NON_INFERIORITY_OR_EQUIVALENCE|A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
71927469|NCT00706901|143376069|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.0002|TWO_SIDED||||||Zero-hurdle Poisson model|||||||.0002
71927470|NCT00706901|143376070|NON_INFERIORITY_OR_EQUIVALENCE|To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.||||||0.04|TWO_SIDED||||||Weibull mixture model|||||||0.04
71927471|NCT00706901|143376070|NON_INFERIORITY_OR_EQUIVALENCE|A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.||||||0.47|TWO_SIDED||||||Mixed Models Analysis|||||||0.47
71927472|NCT00706901|143376071|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.01|TWO_SIDED||||||Zero inflated Poisson model|||||||<0.01
71927473|NCT00706901|143376071|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero-hurdle Poisson model|||||||<.0001
71927474|NCT00706901|143376072|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.0001|TWO_SIDED||||||Zero inflated Poisson model|||||||<.0001
71927475|NCT00706901|143376072|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.02
71927476|NCT00706901|143376073|NON_INFERIORITY_OR_EQUIVALENCE|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.||||||0.17|TWO_SIDED||||||Zero inflated Poisson model|||||||0.17
71927477|NCT00706901|143376073|NON_INFERIORITY_OR_EQUIVALENCE|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.67|TWO_SIDED||||||Zero-hurdle Poisson model|||||||0.67
71927478|NCT03433482|143376074|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% confidence interval (CI) for the hSBA GMT ratio for serogroup A between the MenACWY liquid vaccine aged for approximately 24 months and the licensed MenACWY vaccine is \> 0.5.|GMT ratio|1.21|||||TWO_SIDED|95.0|0.94|1.57|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 24 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination||1.57|0.94|
71927479|NCT03433482|143376074|NON_INFERIORITY|Non-inferiority is concluded if the lower limit of the two sided 95% CI for the hSBA GMT ratios for serogroup A between the MenACWY liquid vaccine aged for approximately 30 months and the licensed MenACWY vaccine is \> 0.5. Non-inferiority hypotheses testing will be conducted sequentially, starting from MenACWY liquid vaccine aged for approximately 24 months and subsequently with MenACWY liquid vaccine aged for approximately 30 months.|GMT ratio|1.11|||||TWO_SIDED|95.0|0.87|1.42|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and country as factors.||To demonstrate non-inferiority of the MenACWY liquid vaccine aged for approximately 30 months to that of currently licensed MenACWY vaccine, as measured by the adjusted hSBA GMTs directed against N. meningitidis serogroup A at Day 29 after a single dose vaccination.||1.42|0.87|
71927480|NCT03433482|143376075|OTHER||GMT ratio|0.84|||||TWO_SIDED|95.0|0.58|1.19|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup C||1.19|0.58|
71927481|NCT03433482|143376075|OTHER||GMT ratio|0.94|||||TWO_SIDED|95.0|0.72|1.24|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup W||1.24|0.72|
71927482|NCT03433482|143376075|OTHER||GMT ratio|1.09|||||TWO_SIDED|95.0|0.82|1.44|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq24 and ACWY\_1, at Day 29 against serogroup Y||1.44|0.82|
71927483|NCT03433482|143376075|OTHER||GMT ratio|1.14|||||TWO_SIDED|95.0|0.79|1.64|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup C||1.64|0.79|
71927484|NCT03433482|143376075|OTHER||GMT ratio|1.1|||||TWO_SIDED|95.0|0.84|1.45|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup W||1.45|0.84|
71927485|NCT03433482|143376075|OTHER||GMT ratio|0.96|||||TWO_SIDED|95.0|0.72|1.26|||ANCOVA|Analysis of Covariance (ANCOVA) including pre-vaccination titer (Day 1) as a covariate and with vaccine group and center (if applicable) as factors.||Between-groups ratio of adjusted hSBA GMTs and its 95% CI, between vaccine groups GSK3536820A ACWY\_Liq30 and ACWY\_2, at Day 29 against serogroup Y||1.26|0.72|
71927486|NCT03433482|143376077|OTHER||Difference in percentage of subjects|2.21|||||TWO_SIDED|95.0|-1.94|6.4|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||6.40|-1.94|
71927487|NCT03433482|143376077|OTHER||Difference in percentage of subjects|-2.12|||||TWO_SIDED|95.0|-8.94|4.72|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||4.72|-8.94|
71927488|NCT03433482|143376077|OTHER||Difference in percentage of subjects|-1.16|||||TWO_SIDED|95.0|-8.11|5.8|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||5.80|-8.11|
71927489|NCT03433482|143376077|OTHER||Difference in percentage of subjects|-1.57|||||TWO_SIDED|95.0|-7.88|4.74|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||4.74|-7.88|
71689755|NCT00685360|142895854|SUPERIORITY||Hazard Ratio (HR)|1.585|||=|0.0232|TWO_SIDED|95.0|1.048|2.399|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.399|1.048|=0.0232
71927490|NCT03433482|143376077|OTHER||Difference in percentage of subjects|-0.12|||||TWO_SIDED|95.0|-4.29|4.07|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup A at Day 29.||4.07|-4.29|
71927491|NCT03433482|143376077|OTHER||Difference in percentage of subjects|2.85|||||TWO_SIDED|95.0|-3.63|9.3|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup C at Day 29.||9.30|-3.63|
71927492|NCT03433482|143376077|OTHER||Difference in percentage of subjects|4.01|||||TWO_SIDED|95.0|-2.89|10.88|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup W at Day 29.||10.88|-2.89|
71927493|NCT03433482|143376077|OTHER||Difference in percentage of subjects|-2.84|||||TWO_SIDED|95.0|-8.91|3.26|||Miettinen and Nurminen score method|||Between-group difference in percentage of subjects with a ≥ 4-fold rise in post-vaccination hSBA for N. meningitidis serogroup Y at Day 29.||3.26|-8.91|
71927494|NCT03433482|143376078|OTHER||Difference in percentage of subjects|1.79|||||TWO_SIDED|95.0|-2.69|6.32|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.32|-2.69|
71927495|NCT03433482|143376078|OTHER||Difference in percentage of subjects|6.96|||||TWO_SIDED|95.0|0.01|13.84|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||13.84|0.01|
71927496|NCT03433482|143376078|OTHER||Difference in percentage of subjects|3.13|||||TWO_SIDED|95.0|-3.33|9.58|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||9.58|-3.33|
71927497|NCT03433482|143376078|OTHER||Difference in percentage of subjects|0.96|||||TWO_SIDED|95.0|-4.86|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||6.80|-4.86|
71927498|NCT03433482|143376078|OTHER||Difference in percentage of subjects|1.46|||||TWO_SIDED|95.0|-2.24|5.22|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||5.22|-2.24|
71927499|NCT03433482|143376078|OTHER||Difference in percentage of subjects|-0.43|||||TWO_SIDED|95.0|-6.32|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||5.46|-6.32|
71927500|NCT03433482|143376078|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 29.||4.18|-7.05|
71927501|NCT03433482|143376078|OTHER||Difference in percentage of subjects|2.04|||||TWO_SIDED|95.0|-2.81|6.9|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||6.90|-2.81|
71927502|NCT03433482|143376078|OTHER||Difference in percentage of subjects|1.5|||||TWO_SIDED|95.0|-3.32|6.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 1.||6.33|-3.32|
71927503|NCT03433482|143376078|OTHER||Difference in percentage of subjects|0.38|||||TWO_SIDED|95.0|-6.6|7.35|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 1.||7.35|-6.60|
71927504|NCT03433482|143376078|OTHER||Difference in percentage of subjects|-1.26|||||TWO_SIDED|95.0|-7.75|5.23|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup W on Day 1.||5.23|-7.75|
71927505|NCT03433482|143376078|OTHER||Difference in percentage of subjects|-0.85|||||TWO_SIDED|95.0|-6.69|4.98|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 1.||4.98|-6.69|
71927506|NCT03433482|143376078|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup A on Day 29.||2.96|-4.24|
71927507|NCT03433482|143376078|OTHER||Difference in percentage of subjects|1.32|||||TWO_SIDED|95.0|-3.99|6.64|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup C on Day 29.||6.64|-3.99|
71927508|NCT03433482|143376078|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 the N. meningitidis serogroup W on Day 29.||9.33|-1.11|
71927509|NCT03433482|143376078|OTHER||Difference in percentage of subjects|0.48|||||TWO_SIDED|95.0|-4.16|5.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥8 for the N. meningitidis serogroup Y on Day 29.||5.13|-4.16|
71927510|NCT03433482|143376079|OTHER||Difference in percentage of subjects|1.29|||||TWO_SIDED|95.0|-3.37|5.99|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||5.99|-3.37|
71927511|NCT03433482|143376079|OTHER||Difference in percentage of subjects|7.23|||||TWO_SIDED|95.0|0.25|14.13|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||14.13|0.25|
71927512|NCT03433482|143376079|OTHER||Difference in percentage of subjects|3.92|||||TWO_SIDED|95.0|-2.57|10.39|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||10.39|-2.57|
71927513|NCT03433482|143376079|OTHER||Difference in percentage of subjects|1.49|||||TWO_SIDED|95.0|-4.44|7.44|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||7.44|-4.44|
71927514|NCT03433482|143376079|OTHER||Difference in percentage of subjects|1.73|||||TWO_SIDED|95.0|-1.94|5.46|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||5.46|-1.94|
71689756|NCT00685360|142895855|SUPERIORITY||Hazard Ratio (HR)|1.846|||=|0.0016|TWO_SIDED|95.0|1.235|2.759|||Stratified Log-Rank Test|P-value was derived from log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||2.759|1.235|=0.0016
71927515|NCT03433482|143376079|OTHER||Difference in percentage of subjects|-0.99|||||TWO_SIDED|95.0|-6.66|4.7|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||4.70|-6.66|
71927516|NCT03433482|143376079|OTHER||Difference in percentage of subjects|-1.43|||||TWO_SIDED|95.0|-7.05|4.18|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||4.18|-7.05|
71927517|NCT03433482|143376079|OTHER||Difference in percentage of subjects|2.06|||||TWO_SIDED|95.0|-2.67|6.8|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||6.80|-2.67|
71927518|NCT03433482|143376079|OTHER||Difference in percentage of subjects|1.75|||||TWO_SIDED|95.0|-3.32|6.83|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 1||6.83|-3.32|
71927519|NCT03433482|143376079|OTHER||Difference in percentage of subjects|3.87|||||TWO_SIDED|95.0|-3.0|10.71|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 1||10.71|-3.00|
71927520|NCT03433482|143376079|OTHER||Difference in percentage of subjects|-0.73|||||TWO_SIDED|95.0|-7.24|5.77|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 1||5.77|-7.24|
71927521|NCT03433482|143376079|OTHER||Difference in percentage of subjects|-1.12|||||TWO_SIDED|95.0|-6.99|4.75|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 1||4.75|-6.99|
71927522|NCT03433482|143376079|OTHER||Difference in percentage of subjects|-0.64|||||TWO_SIDED|95.0|-4.24|2.96|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup A at Day 29||2.96|-4.24|
71927523|NCT03433482|143376079|OTHER||Difference in percentage of subjects|0.0|||||TWO_SIDED|95.0|-5.16|5.16|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup C at Day 29||5.16|-5.16|
71927524|NCT03433482|143376079|OTHER||Difference in percentage of subjects|4.09|||||TWO_SIDED|95.0|-1.11|9.33|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup W at Day 29||9.33|-1.11|
71927525|NCT03433482|143376079|OTHER||Difference in percentage of subjects|0.73|||||TWO_SIDED|95.0|-3.88|5.37|||Miettinen and Nurminen score method|||Between-group difference in percentages of subjects with hSBA titer ≥LLOQ for the N. meningitidis serogroup Y at Day 29||5.37|-3.88|
71927526|NCT00594568|143376085|SUPERIORITY_OR_OTHER|||||||0.134||95.0|||||Mixed Models Analysis|||||||0.134
71927527|NCT00594568|143376085|SUPERIORITY_OR_OTHER|||||||0.045||95.0|||||Mixed Models Analysis|||||||0.045
71927528|NCT00594568|143376085|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||Mixed Models Analysis|||||||0.610
71927529|NCT00594568|143376086|SUPERIORITY_OR_OTHER|||||||0.296||95.0|||||Mixed Models Analysis|||||||0.296
71927530|NCT00594568|143376086|SUPERIORITY_OR_OTHER|||||||0.172||95.0|||||Mixed Models Analysis|||||||0.172
71927531|NCT00594568|143376086|SUPERIORITY_OR_OTHER|||||||0.746||95.0|||||Mixed Models Analysis|||||||0.746
71689757|NCT00685360|142895855|SUPERIORITY||Hazard Ratio (HR)|2.301|||<|0.0001|TWO_SIDED|95.0|1.555|3.405|||Stratified Log-Rank Test|P-value was derived from Log-rank test with SAS PROC LIFETEST for comparisons with placebo.|Hazard ratio computed with SAS PROC PHREG for comparisons with placebo.|||3.405|1.555|<.0001
71927532|NCT00594568|143376087|SUPERIORITY_OR_OTHER|||||||0.166||95.0|||||Mixed Models Analysis|||||||0.166
71927533|NCT00594568|143376087|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71927534|NCT00594568|143376087|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Mixed Models Analysis|||||||0.014
71927535|NCT00594568|143376088|SUPERIORITY_OR_OTHER|||||||0.935||95.0|||||Mixed Models Analysis|||||||0.935
71927536|NCT00594568|143376088|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Mixed Models Analysis|||||||0.068
71927537|NCT00594568|143376088|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||Mixed Models Analysis|||||||0.070
71927538|NCT00594568|143376089|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||||||0.002
71927539|NCT00594568|143376089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71927540|NCT00594568|143376089|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71927541|NCT00594568|143376090|SUPERIORITY_OR_OTHER|||||||0.038||95.0|||||ANCOVA|||||||0.038
71927542|NCT00594568|143376090|SUPERIORITY_OR_OTHER|||||||0.147||95.0|||||ANCOVA|||||||0.147
71927543|NCT00594568|143376090|SUPERIORITY_OR_OTHER|||||||0.604||95.0|||||ANCOVA|||||||0.604
71927544|NCT00594568|143376091|SUPERIORITY_OR_OTHER|||||||0.143||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.143
71927545|NCT00594568|143376091|SUPERIORITY_OR_OTHER|||||||0.464||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.464
71927546|NCT00594568|143376091|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||This is the p-value for the Left Hippocampal Volume|ANCOVA|||||||0.025
71927547|NCT00594568|143376091|SUPERIORITY_OR_OTHER|||||||0.347||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.347
71927548|NCT00594568|143376091|SUPERIORITY_OR_OTHER|||||||0.82||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.820
71927549|NCT00594568|143376091|SUPERIORITY_OR_OTHER|||||||0.243||95.0||||This is the p-value for the Right Hippocampal Volume|ANCOVA|||||||0.243
71927550|NCT00594568|143376092|SUPERIORITY_OR_OTHER|||||||0.784||95.0|||||ANCOVA|||||||0.784
71927551|NCT00594568|143376092|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||ANCOVA|||||||0.931
71927552|NCT00594568|143376092|SUPERIORITY_OR_OTHER|||||||0.718||95.0|||||ANCOVA|||||||0.718
71927553|NCT00594568|143376093|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||ANCOVA|||||||0.634
71927554|NCT00594568|143376093|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|||||||0.901
71927555|NCT00594568|143376093|SUPERIORITY_OR_OTHER|||||||0.659||95.0|||||ANCOVA|||||||0.659
71927556|NCT00594568|143376096|SUPERIORITY_OR_OTHER|||||||0.062||95.0|||||Mixed Models Analysis|||||||0.062
71689758|NCT04208412|142895881|SUPERIORITY|||||||0.001|||||||Wilcoxon Test (Gehan's Generalized)|||||||0.0010
71689759|NCT04208412|142895882|SUPERIORITY|||||||0.0045|||||||Prescott's Test|||||||0.0045
71927557|NCT00594568|143376096|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Mixed Models Analysis|||||||0.022
71927558|NCT00594568|143376096|SUPERIORITY_OR_OTHER|||||||0.669||95.0|||||Mixed Models Analysis|||||||0.669
71927559|NCT00594568|143376097|SUPERIORITY_OR_OTHER|||||||0.071||95.0|||||Mixed Models Analysis|||||||0.071
71927560|NCT00594568|143376097|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||Mixed Models Analysis|||||||0.018
71927561|NCT00594568|143376097|SUPERIORITY_OR_OTHER|||||||0.571||95.0|||||Mixed Models Analysis|||||||0.571
71927562|NCT00594568|143376098|SUPERIORITY_OR_OTHER|||||||0.518||95.0|||||Mixed Models Analysis|||||||0.518
71927563|NCT00594568|143376098|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Mixed Models Analysis|||||||0.013
71927564|NCT00594568|143376098|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Mixed Models Analysis|||||||0.072
71927565|NCT00594568|143376099|SUPERIORITY_OR_OTHER|||||||0.069||95.0|||||Mixed Models Analysis|||||||0.069
71927566|NCT00594568|143376099|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Mixed Models Analysis|||||||0.002
71927567|NCT00594568|143376099|SUPERIORITY_OR_OTHER|||||||0.198||95.0|||||Mixed Models Analysis|||||||0.198
71927568|NCT00594568|143376100|SUPERIORITY_OR_OTHER|||||||0.127||95.0|||||Mixed Models Analysis|||||||0.127
71927569|NCT00594568|143376100|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Mixed Models Analysis|||||||0.016
71927570|NCT00594568|143376100|SUPERIORITY_OR_OTHER|||||||0.381||95.0|||||Mixed Models Analysis|||||||0.381
71927571|NCT00594568|143376101|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Mixed Models Analysis|||||||<0.001
71927572|NCT00594568|143376101|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Mixed Models Analysis|||||||0.005
71927573|NCT00594568|143376101|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Mixed Models Analysis|||||||0.141
71927574|NCT00594568|143376102|SUPERIORITY_OR_OTHER|||||||0.337||95.0|||||ANCOVA|||||||0.337
71927575|NCT00594568|143376102|SUPERIORITY_OR_OTHER|||||||0.018||95.0|||||ANCOVA|||||||0.018
71927576|NCT00594568|143376102|SUPERIORITY_OR_OTHER|||||||0.157||95.0|||||ANCOVA|||||||0.157
71927577|NCT00594568|143376103|SUPERIORITY_OR_OTHER|||||||0.186||95.0|||||Mixed Models Analysis|||||||0.186
71927578|NCT00594568|143376103|SUPERIORITY_OR_OTHER|||||||0.149||95.0|||||Mixed Models Analysis|||||||0.149
71927579|NCT00594568|143376103|SUPERIORITY_OR_OTHER|||||||0.889||95.0|||||Mixed Models Analysis|||||||0.889
71927580|NCT00594568|143376104|SUPERIORITY_OR_OTHER|||||||0.202||95.0|||||Mixed Models Analysis|||||||0.202
71927581|NCT00594568|143376104|SUPERIORITY_OR_OTHER|||||||0.075||95.0|||||Mixed Models Analysis|||||||0.075
71927582|NCT00594568|143376104|SUPERIORITY_OR_OTHER|||||||0.616||95.0|||||Mixed Models Analysis|||||||0.616
71927583|NCT01656850|143376125|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71927584|NCT01656850|143376126|SUPERIORITY_OR_OTHER|||||||0.2786|TWO_SIDED||||||Mixed Models Analysis|||||||0.2786
71927585|NCT01656850|143376127|SUPERIORITY_OR_OTHER|||||||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.420
71927586|NCT01656850|143376128|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.0001
71927587|NCT01656850|143376129|SUPERIORITY_OR_OTHER|||||||0.2412|TWO_SIDED||||||Mixed Models Analysis|||||||0.2412
71927588|NCT01656850|143376130|SUPERIORITY_OR_OTHER|||||||0.3837|TWO_SIDED||||||Mixed Models Analysis|||||||0.3837
71927589|NCT01656850|143376131|SUPERIORITY_OR_OTHER|||||||0.9784|TWO_SIDED||||||Mixed Models Analysis|||||||0.9784
71927590|NCT01656850|143376132|SUPERIORITY_OR_OTHER|||||||0.5868|TWO_SIDED||||||Mixed Models Analysis|||||||0.5868
71927591|NCT01656850|143376133|SUPERIORITY_OR_OTHER|||||||0.1101|TWO_SIDED||||||Mixed Models Analysis|||||||0.1101
71927592|NCT01656850|143376134|SUPERIORITY_OR_OTHER|||||||0.7823|TWO_SIDED||||||Mixed Models Analysis|||||||0.7823
71927593|NCT01656850|143376135|SUPERIORITY_OR_OTHER|||||||0.557|TWO_SIDED||||||Mixed Models Analysis|||||||0.5570
71927594|NCT01656850|143376136|SUPERIORITY_OR_OTHER|||||||0.6263|TWO_SIDED||||||Mixed Models Analysis|||||||0.6263
71927595|NCT01656850|143376137|SUPERIORITY_OR_OTHER|||||||0.8328|TWO_SIDED||||||Mixed Models Analysis|||||||0.8328
71927596|NCT01656850|143376138|SUPERIORITY_OR_OTHER|||||||0.7758|TWO_SIDED||||||Mixed Models Analysis|||||||0.7758
71927597|NCT01656850|143376139|SUPERIORITY_OR_OTHER|||||||0.0476|TWO_SIDED||||||Mixed Models Analysis|||||||0.0476
71927598|NCT01656850|143376140|SUPERIORITY_OR_OTHER|||||||0.1205|TWO_SIDED||||||Mixed Models Analysis|||||||0.1205
71927599|NCT01656850|143376141|SUPERIORITY_OR_OTHER|||||||0.1512|TWO_SIDED||||||Mixed Models Analysis|||||||0.1512
71927600|NCT01656850|143376142|SUPERIORITY_OR_OTHER|||||||0.7364|TWO_SIDED||||||Mixed Models Analysis|||||||0.7364
71927601|NCT01656850|143376143|SUPERIORITY_OR_OTHER|||||||0.1995|TWO_SIDED||||||Mixed Models Analysis|||||||0.1995
71927602|NCT01656850|143376144|SUPERIORITY_OR_OTHER|||||||0.8528|TWO_SIDED||||||Mixed Models Analysis|||||||0.8528
71927603|NCT00296192|143376146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.91||||95.0|-2.9|8.7|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.7|-2.9|
71927604|NCT00296192|143376146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|2.93||||95.0|-5.7|6.0|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||6.0|-5.7|
71927605|NCT00296192|143376146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.9|STANDARD_ERROR_OF_MEAN|2.86||||95.0|-2.8|8.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||8.6|-2.8|
71927606|NCT00296192|143376146|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|3.02||||95.0|-7.4|4.6|||ANCOVA|||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.||4.6|-7.4|
71927607|NCT00296192|143376147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.6|STANDARD_ERROR_OF_MEAN|8.58||||95.0|-25.7|8.5|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||8.5|-25.7|
71927608|NCT00296192|143376147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.8|STANDARD_ERROR_OF_MEAN|8.63||||95.0|-34.0|0.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||0.4|-34.0|
71927609|NCT00296192|143376147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4|STANDARD_ERROR_OF_MEAN|8.45||||95.0|-18.2|15.4|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||15.4|-18.2|
71927610|NCT00296192|143376147|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.5|STANDARD_ERROR_OF_MEAN|8.9||||95.0|-23.3|12.2|||ANCOVA|||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.||12.2|-23.3|
71927611|NCT00296192|143376148|SUPERIORITY_OR_OTHER||Difference in proportions|-20.6||||||95.0|-53.3|12.1|||Confidence interval|||95% confidence interval in difference in success rate||12.1|-53.3|
71927612|NCT00296192|143376148|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
71927613|NCT00296192|143376148|SUPERIORITY_OR_OTHER||Difference in proportions|0.0||||||95.0|-30.6|30.6|||95% confidence interval|||95% confidence interval in difference in success rate||30.6|-30.6|
71927614|NCT00296192|143376148|SUPERIORITY_OR_OTHER||Difference in proportions|4.4||||||95.0|-25.9|34.7|||95% confidence interval|||95% confidence interval in difference in success rate||34.7|-25.9|
71927615|NCT02060526|143376175|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.286||||0.4615|TWO_SIDED|95.0|-0.297|0.745|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.745|-0.297|0.4615
71927616|NCT02060526|143376175|SUPERIORITY_OR_OTHER_LEGACY||Difference between proportions|0.143||||1|TWO_SIDED|95.0|-0.423|0.647|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.||0.647|-0.423|1.0000
71927617|NCT02354352|143376203|NON_INFERIORITY|Using a Type I error rate of 5%, we conducted a power calculation using a non-inferiority test on 12-month change in Ecc. If there is truly no difference in the 12-month Ecc change between the spironolactone and eplerenone groups, 46 patients (23 in each group) would result in at least 80% power to ensure that the lower limit of a one-sided 95% confidence interval for the true difference between the spironolactone and eplerenone groups to be above the non-inferiority limit of -1.75.||||||0.5867|||||||Wilcoxon (Mann-Whitney)|||||||0.5867
71927618|NCT04633434|143376204|EQUIVALENCE|Test of whether the pretest and posttest scores are significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.56||0.69|TWO_SIDED||||||t-test, 2 sided||Estimation parameter based on paired t-test.|||||.690
71927619|NCT04633434|143376205|EQUIVALENCE|Test of whether pretest to posttest score change is greater than zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.308||0.052|TWO_SIDED||||||t-test, 2 sided|||||||.052
71927620|NCT04633434|143376206|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.647|STANDARD_ERROR_OF_MEAN|0.41||0.135|TWO_SIDED||||||t-test, 2 sided|||||||.135
71927621|NCT04633434|143376207|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|7.14||0.026|TWO_SIDED||||||t-test, 2 sided|||||||.026
71927622|NCT04633434|143376208|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71927623|NCT04633434|143376209|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71927624|NCT04633434|143376210|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-1.11|STANDARD_ERROR_OF_MEAN|0.54||0.057|TWO_SIDED||||||t-test, 2 sided|||||||.057
71927625|NCT04633434|143376211|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|1.89|<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71927626|NCT04633434|143376212|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.1||0.352|TWO_SIDED||||||t-test, 2 sided|||||||.352
71927627|NCT04633434|143376213|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13||0.104|TWO_SIDED||||||t-test, 2 sided|||||||.104
71927628|NCT04633434|143376216|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.33|STANDARD_ERROR_OF_MEAN|0.19||0.106|TWO_SIDED||||||t-test, 2 sided|||||||.106
71927629|NCT04633434|143376217|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.005|TWO_SIDED||||||t-test, 2 sided|||||||.005
71927630|NCT04633434|143376218|EQUIVALENCE|Test of whether pretest to posttest change is significantly different from zero.|Mean Difference (Final Values)|3.52|STANDARD_ERROR_OF_MEAN|1.9||0.082|TWO_SIDED||||||t-test, 2 sided|||||||.082
71927631|NCT00585468|143376242|SUPERIORITY_OR_OTHER|||||||0.0163|||||||t-test, 2 sided|||||||0.0163
71927632|NCT00585468|143376243|SUPERIORITY_OR_OTHER|||||||0.039|||||||t-test, 2 sided|||||||0.039
71927633|NCT00585468|143376245|SUPERIORITY_OR_OTHER|||||||0.146|||||||t-test, 2 sided|||||||0.146
71927634|NCT00585468|143376246|SUPERIORITY_OR_OTHER|||||||0.4937|||||||t-test, 2 sided|||||||0.4937
71927635|NCT00585468|143376247|SUPERIORITY_OR_OTHER|||||||0.9669|||||||t-test, 2 sided|||||||0.9669
71927636|NCT00585468|143376249|SUPERIORITY_OR_OTHER|||||||0.9607|||||||t-test, 2 sided|||||||0.9607
71927637|NCT00943826|143376256|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64|||<|0.0001|TWO_SIDED|95.0|0.55|0.74||Stratified by Region and Recursive partitioning analysis (RPA) Class|Log Rank||Stratified by Region and RPA Class.|||0.74|0.55|<0.0001
71927638|NCT00943826|143376257|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88||||0.0987|TWO_SIDED|95.0|0.76|1.02|||Log Rank|Stratified by Region and RPA Class|Stratified by Region and RPA Class.|||1.02|0.76|0.0987
71927639|NCT00943826|143376258|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.53|0.71||Stratified by Region and RPA Class.|Log Rank||Stratified by Region and RPA Class.|||0.71|0.53|<0.0001
71927640|NCT00517868|143376263|NON_INFERIORITY|A paired student t comparison was used to assess treatment differences as measured by 11 point numerical rating scale.|Mean Difference (Final Values)|-21.14||||0.0363|TWO_SIDED|95.0|-44.43|2.16|||t-test, 1 sided|||||2.16|-44.43|0.0363
71927641|NCT02234427|143376275|SUPERIORITY_OR_OTHER||||||<|5e-06||||||Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.|negative binomial|||Null Hypothesis: There is no difference in gene expression before and after aspirin therapy||||<0.000005
71927642|NCT02279888|143376283|OTHER|the lower limit of the two-sided 95% confidence interval on the freedom from DSRC rate at 24 months is greater than 80%|Kaplan Meier|0.05|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71927643|NCT02279888|143376285|OTHER||Hazard Ratio (HR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.39|0.47|||Andersen-Gill||This analysis applies to Primary Outcome: HFH Rate|||0.47|0.39|<0.0001
71927644|NCT02279888|143376287|OTHER||Hazard Ratio (HR)|0.57|||<|0.0001|TWO_SIDED|95.0|0.52|0.62|||Andersen-Gill|||||0.62|0.52|<0.0001
71927645|NCT00650806|143376325|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|0.4||0.031|TWO_SIDED|95.0|-1.6|-0.1|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.1|-1.6|0.031
71927646|NCT00650806|143376325|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.8|-2.4|<0.001
71927647|NCT00650806|143376325|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.4|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-2.1|-0.6|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.||||-0.6|-2.1|<0.001
71927648|NCT00650806|143376326|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.4||0.045|TWO_SIDED|95.0|-1.58|-0.02|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.02|-1.58|0.045
71927649|NCT00650806|143376326|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.41|<|0.001|TWO_SIDED|95.0|-2.4|-0.8|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.80|-2.40|<0.001
71927650|NCT00650806|143376326|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.07|-0.51|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.||||-0.51|-2.07|0.001
71927651|NCT00650806|143376327|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.14||0.031|TWO_SIDED|95.0|-0.59|-0.03|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.03|-0.59|0.031
71927652|NCT00650806|143376327|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.32|-0.90|<0.001
71927653|NCT00650806|143376327|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.76|-0.2|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||-0.20|-0.76|<0.001
71927654|NCT00650806|143376328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.317||95.0|0.6|5.6||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||5.6|0.6|0.317
71927655|NCT00650806|143376328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.059|TWO_SIDED|95.0|0.9|11.1||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||11.1|0.9|0.059
71927656|NCT00650806|143376328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.1||||0.027|TWO_SIDED|95.0|1.0|10.0||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.|||10.0|1.0|0.027
71927657|NCT00650806|143376329|SUPERIORITY_OR_OTHER|||||||0.117|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.117
71927658|NCT00650806|143376329|SUPERIORITY_OR_OTHER|||||||0.225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.225
71927659|NCT00650806|143376329|SUPERIORITY_OR_OTHER|||||||0.317|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.||||||0.317
71927660|NCT00650806|143376330|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|1.23||0.835|TWO_SIDED|95.0|-2.68|2.17|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||2.17|-2.68|0.835
71927661|NCT00650806|143376330|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.94|STANDARD_ERROR_OF_MEAN|1.29||0.466|TWO_SIDED|95.0|-3.47|1.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.59|-3.47|0.466
71927662|NCT00650806|143376330|SUPERIORITY_OR_OTHER||Least-Sqaures Mean Difference|-1.37|STANDARD_ERROR_OF_MEAN|1.25||0.273|TWO_SIDED|95.0|-3.87|1.09|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.09|-3.87|0.273
71927663|NCT00650806|143376331|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.63|STANDARD_ERROR_OF_MEAN|1.13||0.149|TWO_SIDED|95.0|-3.85|0.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.59|-3.85|0.149
71927664|NCT00650806|143376331|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|1.18||0.541|TWO_SIDED|95.0|-3.05|1.6|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||1.6|-3.05|0.541
71927665|NCT00650806|143376331|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.78|STANDARD_ERROR_OF_MEAN|1.15||0.121|TWO_SIDED|95.0|-4.03|0.47|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.47|-4.03|0.121
71927666|NCT00650806|143376332|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.011|STANDARD_ERROR_OF_MEAN|0.0091||0.239|TWO_SIDED|95.0|-0.0071|0.0286|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0286|-0.0071|0.239
71927667|NCT00650806|143376332|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.001|STANDARD_ERROR_OF_MEAN|0.0095||0.9|TWO_SIDED|95.0|-0.0174|0.0198|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0198|-0.0174|0.900
71927668|NCT00650806|143376332|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|0.002|STANDARD_ERROR_OF_MEAN|0.0092||0.822|TWO_SIDED|95.0|-0.016|0.0202|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.||||0.0202|-0.0160|0.822
71927669|NCT03707145|143376337|SUPERIORITY||Partial Eta Squared|0.058|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
71927670|NCT03707145|143376338|SUPERIORITY||Partial Eta Squared|0.008|||||TWO_SIDED|||||||||Partial Eta Squared was calculated based on ANOVA with Time (pre-post) as within subject factor and Empowerment (Professional led versus Patient Empowered) as between subject factor.||||
71927671|NCT05014672|143376344|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.86||||0.0206|TWO_SIDED|95.0|0.746|0.994|||Mixed Model Repeated Measures|||||0.994|0.746|0.0206
71927672|NCT05014672|143376344|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.81||||0.0057|TWO_SIDED|95.0|0.703|0.939|||Mixed Model Repeated Measures|||||0.939|0.703|0.0057
71927673|NCT05014672|143376345|SUPERIORITY||LS mean difference vs placebo|-2.16||||0.2214|TWO_SIDED|95.0|-7.785|3.458|||Mixed Model Repeated Measures|||||3.458|-7.785|0.2214
71927674|NCT05014672|143376345|SUPERIORITY||LS mean difference vs placebo|0.63||||0.591|TWO_SIDED|95.0|-4.859|6.12|||Mixed Model Repeated Measures|||||6.120|-4.859|0.5910
71927675|NCT05014672|143376348|SUPERIORITY||LS mean difference vs placebo|0.42||||0.5675|TWO_SIDED|95.0|-4.454|5.285|||Mixed Model Repeated Measures|||||5.285|-4.454|0.5675
71927676|NCT05014672|143376348|SUPERIORITY||LS mean difference vs placebo|0.02||||0.5032|TWO_SIDED|95.0|-4.886|4.926|||Mixed Model Repeated Measures|||||4.926|-4.886|0.5032
71927677|NCT05014672|143376349|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.85||||0.0491|TWO_SIDED|95.0|0.692|1.033|||Mixed Model Repeated Measures|||||1.033|0.692|0.0491
71927678|NCT05014672|143376349|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.95||||0.3099|TWO_SIDED|95.0|0.783|1.158|||Mixed Model Repeated Measures|||||1.158|0.783|0.3099
71927679|NCT05014672|143376355|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.84||||0.0039|TWO_SIDED|95.0|0.743|0.954|||Mixed Model Repeated Measures|||||0.954|0.743|0.0039
71927680|NCT05014672|143376356|SUPERIORITY||LS mean difference vs placebo|0.3905||||0.3905|TWO_SIDED|95.0|-5.496|4.153|||Mixed Model Repeated Measures|||||4.153|-5.496|0.3905
71927681|NCT05014672|143376357|SUPERIORITY||LS mean difference vs placebo|0.21||||0.5393|TWO_SIDED|95.0|-3.968|4.381|||Mixed Model Repeated Measures|||||4.381|-3.968|0.5393
71927682|NCT05014672|143376358|SUPERIORITY||Ratio of geometric LS mean vs placebo|0.9||||0.1079|TWO_SIDED|95.0|0.759|1.065|||Mixed Model Repeated Measures|||||1.065|0.759|0.1079
71927683|NCT00965562|143376359|SUPERIORITY_OR_OTHER|||||||0.15||95.0|||||Chi-squared|||||||0.15
71927684|NCT00965562|143376360|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Chi-squared|||||||0.05
71927685|NCT00965562|143376361|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71927686|NCT00965562|143376362|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Chi-squared|||||||0.09
71927687|NCT00965562|143376363|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||Chi-squared|||||||0.005
71927688|NCT00965562|143376364|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||0.04
71927689|NCT00965562|143376365|SUPERIORITY_OR_OTHER||Slope|-2.63||||0.07|TWO_SIDED|95.0|-5.51|0.24|||Mixed Models Analysis||Slope represents average change in fluoxetine group IDS score as compared to placebo|||0.24|-5.51|0.07
71927690|NCT00965562|143376365|SUPERIORITY_OR_OTHER||Slope|-0.1||||0.94|TWO_SIDED|95.0|-2.85|2.65|||Mixed Models Analysis||Slope represents average change in calcium group IDS scores as compared to placebo|||2.65|-2.85|0.94
71927691|NCT00965562|143376365|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.15||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
71927692|NCT00965562|143376365|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.1||||0.94|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.94
71927693|NCT00965562|143376366|SUPERIORITY_OR_OTHER||Slope|-1.63||||0.1|TWO_SIDED|95.0|-3.6|0.34|||Mixed Models Analysis||Slope represents average change in fluoxetine group PMTS scores as compared to placebo|||0.34|-3.60|0.10
71927694|NCT00965562|143376366|SUPERIORITY_OR_OTHER||Slope|-0.81||||0.4|TWO_SIDED|95.0|-2.71|1.09|||Mixed Models Analysis||Slope represents average change in calcium group PMTS scores as compared to placebo|||1.09|-2.71|0.40
71927695|NCT00965562|143376366|SUPERIORITY_OR_OTHER||Cohen's d effect size|1.06||||0.1|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.10
71927696|NCT00965562|143376366|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.37||||0.4|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.40
71927697|NCT00965562|143376367|SUPERIORITY_OR_OTHER||Slope|-0.35||||0.07|TWO_SIDED|95.0|-0.73|0.03|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI-S scores as compared to placebo|||0.03|-0.73|0.07
71927698|NCT00965562|143376367|SUPERIORITY_OR_OTHER||Slope|-0.17||||0.36|TWO_SIDED|95.0|-0.54|0.2|||Mixed Models Analysis||Slope represents average change in calcium group CGI-S scores as compared to placebo|||0.20|-0.54|0.36
71927699|NCT00965562|143376367|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.92||||0.07|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.07
71927700|NCT00965562|143376367|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.44||||0.36|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.36
71927701|NCT00965562|143376368|SUPERIORITY_OR_OTHER||Slope|-0.28||||0.02|TWO_SIDED|95.0|-0.53|-0.04|||Mixed Models Analysis||Slope represents average change in fluoxetine group DRSP scores as compared to placebo|||-0.04|-0.53|0.02
71927702|NCT00965562|143376368|SUPERIORITY_OR_OTHER||Slope|0.06||||0.58|TWO_SIDED|95.0|-0.16|0.28|||Mixed Models Analysis||Slope represents average change in calcium group DRSP scores as compared to placebo|||0.28|-0.16|0.58
71927703|NCT00965562|143376368|SUPERIORITY_OR_OTHER||Cohen's d effect size|2.08||||0.02|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.02
71927704|NCT00965562|143376368|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.18||||0.58|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5|||||0.58
71927705|NCT00965562|143376369|SUPERIORITY_OR_OTHER||Slope|-1.03||||0.04|TWO_SIDED|95.0|-1.7|-0.35|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI Improvement scores as compared to placebo|||-0.35|-1.70|0.04
71927706|NCT00965562|143376369|SUPERIORITY_OR_OTHER||Slope|-0.2||||0.54|TWO_SIDED|95.0|-0.86|0.46|||Mixed Models Analysis||Slope represents average change in calcium group CGI Improvement scores as compared to placebo|||0.46|-0.86|0.54
71927707|NCT00965562|143376369|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.8||||0.04|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.04
71927708|NCT00965562|143376369|SUPERIORITY_OR_OTHER||Cohen's d effect size|0.32||||0.54|TWO_SIDED||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5|||||0.54
71927709|NCT04636437|143376370|SUPERIORITY||Mean Difference (Net)|1.36||||0.23|TWO_SIDED|97.5|-1.2|3.92||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||3.92|-1.20|0.23
71927710|NCT04636437|143376370|SUPERIORITY||Mean Difference (Net)|-0.89||||0.41|TWO_SIDED|97.5|-3.34|1.57||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 48.||1.57|-3.34|0.41
71927711|NCT04636437|143376371|SUPERIORITY||Mean Difference (Net)|0.83||||0.31|TWO_SIDED|97.5|-0.99|2.64||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||2.64|-0.99|0.31
71927712|NCT04636437|143376371|SUPERIORITY||Mean Difference (Net)|-1.99||||0.012|TWO_SIDED|97.5|-3.76|-0.21||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in body weight from entry to week 24.||-0.21|-3.76|0.012
71927713|NCT04636437|143376372|SUPERIORITY||Mean Difference (Net)|1.72||||0.2|TWO_SIDED|97.5|-1.33|4.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||4.77|-1.33|0.20
71927714|NCT04636437|143376372|SUPERIORITY||Mean Difference (Net)|-1.49||||0.25|TWO_SIDED|97.5|-4.43|1.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 48.||1.44|-4.43|0.25
71927715|NCT04636437|143376373|SUPERIORITY||Mean Difference (Net)|-0.16||||0.9|TWO_SIDED|97.5|-3.23|2.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||2.90|-3.23|0.90
71927716|NCT04636437|143376373|SUPERIORITY||Mean Difference (Net)|-1.48||||0.26|TWO_SIDED|97.5|-4.47|1.51||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in waist circumference from entry to week 24.||1.51|-4.47|0.26
71927717|NCT04636437|143376374|SUPERIORITY||Mean Difference (Net)|1.19||||0.91|TWO_SIDED|97.5|-22.2|24.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||24.59|-22.2|0.91
71927718|NCT04636437|143376374|SUPERIORITY||Mean Difference (Net)|-7.1||||0.48|TWO_SIDED|97.5|-29.7|15.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 48.||15.47|-29.7|0.48
71927719|NCT04636437|143376375|SUPERIORITY||Mean Difference (Net)|-15.2||||0.3|TWO_SIDED|97.5|-48.6|18.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||18.20|-48.6|0.30
71927720|NCT04636437|143376375|SUPERIORITY||Mean Difference (Net)|-18.5||||0.21|TWO_SIDED|97.5|-51.8|14.76||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting triglycerides, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting triglycerides from entry to week 24.||14.76|-51.8|0.21
71927721|NCT04636437|143376376|SUPERIORITY||Mean Difference (Net)|-2.84||||0.58|TWO_SIDED|97.5|-14.4|8.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||8.72|-14.4|0.58
71927722|NCT04636437|143376376|SUPERIORITY||Mean Difference (Net)|-6.88||||0.16|TWO_SIDED|97.5|-18.0|4.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 48.||4.20|-18.0|0.16
71927723|NCT04636437|143376377|SUPERIORITY||Mean Difference (Net)|-2.92||||0.47|TWO_SIDED|97.5|-12.1|6.27||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||6.27|-12.1|0.47
71927724|NCT04636437|143376377|SUPERIORITY||Mean Difference (Net)|-15.1|||<|0.001|TWO_SIDED|97.5|-24.2|-5.91||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting LDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting LDL from entry to week 24.||-5.91|-24.2|<0.001
71927725|NCT04636437|143376378|SUPERIORITY||Mean Difference (Net)|0.8||||0.79|TWO_SIDED|97.5|-6.17|7.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||7.77|-6.17|0.79
71927726|NCT04636437|143376378|SUPERIORITY||Mean Difference (Net)|-5.46||||0.063|TWO_SIDED|97.5|-12.1|1.16||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 48.||1.16|-12.1|0.063
71927727|NCT04636437|143376379|SUPERIORITY||Mean Difference (Net)|-1.38||||0.27|TWO_SIDED|97.5|-4.21|1.45||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||1.45|-4.21|0.27
71927728|NCT04636437|143376379|SUPERIORITY||Mean Difference (Net)|-5.45|||<|0.001|TWO_SIDED|97.5|-8.25|-2.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting HDL, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting HDL from entry to week 24.||-2.66|-8.25|<0.001
71927729|NCT04636437|143376380|SUPERIORITY||Mean Difference (Net)|1.55||||0.77|TWO_SIDED|97.5|-10.3|13.44||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||13.44|-10.3|0.77
71927730|NCT04636437|143376380|SUPERIORITY||Mean Difference (Net)|-5.23||||0.3|TWO_SIDED|97.5|-16.7|6.2||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 48.||6.20|-16.7|0.30
71927731|NCT04636437|143376381|SUPERIORITY||Mean Difference (Net)|0.18||||0.96|TWO_SIDED|97.5|-8.78|9.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||9.15|-8.78|0.96
71927732|NCT04636437|143376381|SUPERIORITY||Mean Difference (Net)|-6.32||||0.11|TWO_SIDED|97.5|-15.2|2.55||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting glucose, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting glucose from entry to week 24.||2.55|-15.2|0.11
71927733|NCT04636437|143376382|SUPERIORITY||Mean Difference (Net)|8.07||||0.16|TWO_SIDED|97.5|-4.93|21.06||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.06|-4.93|0.16
71927734|NCT04636437|143376382|SUPERIORITY||Mean Difference (Net)|8.89||||0.1|TWO_SIDED|97.5|-3.37|21.15||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 48.||21.15|-3.37|0.10
71927735|NCT04636437|143376383|SUPERIORITY||Mean Difference (Net)|4.28||||0.37|TWO_SIDED|97.5|-6.42|14.99||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||14.99|-6.42|0.37
71927736|NCT04636437|143376383|SUPERIORITY||Mean Difference (Net)|0.37||||0.94|TWO_SIDED|97.5|-10.0|10.77||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry fasting insulin, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in fasting insulin from entry to week 24.||10.77|-10.0|0.94
71927737|NCT04636437|143376384|SUPERIORITY||Mean Difference (Net)|2.77||||0.2|TWO_SIDED|97.5|-2.08|7.63||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||7.63|-2.08|0.20
71927738|NCT04636437|143376384|SUPERIORITY||Mean Difference (Net)|2.21||||0.28|TWO_SIDED|97.5|-2.44|6.87||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 48.||6.87|-2.44|0.28
71927739|NCT04636437|143376385|SUPERIORITY||Mean Difference (Net)|1.79||||0.24|TWO_SIDED|97.5|-1.68|5.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||5.25|-1.68|0.24
71927740|NCT04636437|143376385|SUPERIORITY||Mean Difference (Net)|-0.57||||0.7|TWO_SIDED|97.5|-3.91|2.78||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in absolute change in HOMA-IR from entry to week 24.||2.78|-3.91|0.70
71927741|NCT04636437|143376387|SUPERIORITY|||||||0.43||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.43
71927742|NCT04636437|143376387|SUPERIORITY|||||||0.26||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of Grade ≥3 AEs from entry to week 48.||||0.26
71927743|NCT04636437|143376388|SUPERIORITY|||||||0.008||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.008
71927744|NCT04636437|143376388|SUPERIORITY|||||||0.068||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of \>10% reduction in CrCl from entry to week 48.||||0.068
71927745|NCT04636437|143376389|SUPERIORITY|||||||0.2||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.20
71927746|NCT04636437|143376389|SUPERIORITY|||||||0.56||||||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in occurrence of premature discontinuation of study treatment from entry to week 48.||||0.56
71927747|NCT04636437|143376390|SUPERIORITY||Mean Difference (Net)|3.43||||0.13|TWO_SIDED|97.5|-1.62|8.47||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||8.47|-1.62|0.13
71927748|NCT04636437|143376390|SUPERIORITY||Mean Difference (Net)|-0.09||||0.97|TWO_SIDED|97.5|-4.89|4.72||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in total fat from entry to week 48.||4.72|-4.89|0.97
71927749|NCT04636437|143376391|SUPERIORITY||Mean Difference (Net)|0.31||||0.78|TWO_SIDED|97.5|-2.18|2.8||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||2.80|-2.18|0.78
71927750|NCT04636437|143376391|SUPERIORITY||Mean Difference (Net)|1.24||||0.23|TWO_SIDED|97.5|-1.11|3.59||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lean mass from entry to week 48.||3.59|-1.11|0.23
71927751|NCT04636437|143376392|SUPERIORITY||Mean Difference (Net)|3.71||||0.18|TWO_SIDED|97.5|-2.48|9.9||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||9.90|-2.48|0.18
71927752|NCT04636437|143376392|SUPERIORITY||Mean Difference (Net)|-1.35||||0.6|TWO_SIDED|97.5|-7.23|4.53||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in trunk fat from entry to week 48.||4.53|-7.23|0.60
71927753|NCT04636437|143376393|SUPERIORITY||Mean Difference (Net)|4.19||||0.094|TWO_SIDED|97.5|-1.45|9.83||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|9.83|-1.45|0.094
71927754|NCT04636437|143376393|SUPERIORITY||Mean Difference (Net)|1.76||||0.46|TWO_SIDED|97.5|-3.59|7.11||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear|||Null hypothesis: There is no difference between the two arms in percent change in limb fat from entry to week 48.|Mean difference and CI come from a linear regression model adjusting for entry limb fat, sex, and race (Black and not Black).|7.11|-3.59|0.46
71927755|NCT04636437|143376394|SUPERIORITY||Mean Difference (Net)|2.19||||0.26|TWO_SIDED|97.5|-2.19|6.56||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||6.56|-2.19|0.26
71927756|NCT04636437|143376394|SUPERIORITY||Mean Difference (Net)|3.15||||0.084|TWO_SIDED|97.5|-0.96|7.25||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in appendicular lean mass from entry to week 48.||7.25|-0.96|0.084
71689760|NCT04208412|142895883|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||"Gehan's Generalized Wilcoxon Test:~600 mg KVD900 vs Placebo"||||<0.0001
71927757|NCT04636437|143376395|SUPERIORITY||Mean Difference (Net)|0.78||||0.19|TWO_SIDED|97.5|-0.57|2.13||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||2.13|-0.57|0.19
71927758|NCT04636437|143376395|SUPERIORITY||Mean Difference (Net)|-0.64||||0.27|TWO_SIDED|97.5|-1.93|0.66||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in hip bone mineral density from entry to week 48.||0.66|-1.93|0.27
71927759|NCT04636437|143376396|SUPERIORITY||Mean Difference (Net)|0.5||||0.58|TWO_SIDED|97.5|-1.57|2.58||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.58|-1.57|0.58
71927760|NCT04636437|143376396|SUPERIORITY||Mean Difference (Net)|0.05||||0.95|TWO_SIDED|97.5|-1.93|2.03||Bonferroni adjustment for 2 pairwise comparisons of DOR-containing arms versus continuation of INSTI. Two sided 2.5% alpha.|Regression, Linear||Mean difference and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).|Null hypothesis: There is no difference between the two arms in percent change in lumbar spine bone mineral density from entry to week 48.||2.03|-1.93|0.95
71927761|NCT01977482|143376467|SUPERIORITY_OR_OTHER||E0 (g/dL)|-0.664|||||TWO_SIDED|95.0|-0.96|-0.387|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.387|-0.960|
71927762|NCT01977482|143376467|SUPERIORITY_OR_OTHER||ED50 (milligrams[mg])|33.531|||||TWO_SIDED|95.0|15.566|48.948|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||48.948|15.566|
71927763|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Emax (g/dL)|5.234||||||95.0|2.691|7.94|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||7.940|2.691|
71927764|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Gamma|1.145|||||TWO_SIDED|95.0|0.748|1.738|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.738|0.748|
71927765|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Var|1.012|||||TWO_SIDED|95.0|0.84|1.234|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||1.234|0.840|
71927766|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Alpha|-0.206|||||TWO_SIDED|95.0|-0.397|-0.014|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||-0.014|-0.397|
71927767|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Minimally Effective Dose (MED) (mg)|0.418|||||TWO_SIDED|95.0|0.0|2.342|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||2.342|0.000|
71927768|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Dose that achieves a change of -0.25g/dL|2.423|||||TWO_SIDED|95.0|0.0|4.15|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||4.150|0.000|
71927769|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Target Dose (TD) (mg)|4.406|||||TWO_SIDED|95.0|2.544|5.995|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||5.995|2.544|
71927770|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.25 g/dL|6.43|||||TWO_SIDED|95.0|4.698|8.01|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||8.010|4.698|
71927771|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.5 g/dL|8.542|||||TWO_SIDED|95.0|6.931|10.523|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||10.523|6.931|
71927772|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Dose that achieves a change of 0.75 g/dL|10.8|||||TWO_SIDED|95.0|9.024|14.004|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||14.004|9.024|
71927773|NCT01977482|143376467|SUPERIORITY_OR_OTHER||Dose that achieves a change of 1 g/dL|13.248|||||TWO_SIDED|95.0|10.891|18.916|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.|||18.916|10.891|
71927774|NCT05554471|143376503|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: the time to ambulation for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used.||||<0.001
71927775|NCT05554471|143376504|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: the time to hemostasis for the MYNX CONTROL™ Venous VCD device is at least 5 minutes less than manual compression.||||<0.001
71927776|NCT05554471|143376506|SUPERIORITY||||||<|0.001|||||||t-test, 1 sided|||Hypothesis: The time to discharge eligibility for the subjects using the MYNX CONTROL™ Venous VCD was significantly less than for those where manual compression was used||||<0.001
71927777|NCT00526227|143376530|OTHER|An exact one-sided 97% upper confidence bound or a p-value will be calculated based on the observed percentage of subjects with an USADE within the first month post-implant. This rate will be considered acceptable if the one-sided 97% upper confidence bound is less than 10% or, equivalently, if the p-value is less than 0.0304.|Percentage|7.7|||||ONE_SIDED|97.0|||||||The CI was calculated based on 44 patients at interim analysis: 0 USADE were reported within 1-month post implant, ie 0% of subjects experienced a USADE. The one-sided 97% exact binomial upper confidence bound was 7.7% which is lower than 10%.|"H 0 (null hypothesis): P ≥ 10%; H A (alternative hypothesis): P \< 10%, where P is the percentage of subjects experiencing a USADE through the 1-month post implant.~An upper limit of the confidence interval of the percentage subjects with USADE not greater than or equal to 10% at the 1-month follow-up visit provides a reasonably-sized clinical study with sufficient power to detect USADEs."||||
71927778|NCT06212544|143376535|SUPERIORITY||||||<|0.05|||||||ANOVA|||||||<0.05
71927779|NCT04074109|143376550|OTHER|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
71927780|NCT04074109|143376550|OTHER|||||||||||||||||This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used. We report percentages and frequencies to show feasibility|This is a feasibility study which is not powered for efficacy. Therefore no formal statistical tests are used.|||
71927781|NCT01939834|143376561|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71927782|NCT00795210|143376570|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|||Kruskal-Wallis Test for overall difference between groups||||0.01
71927783|NCT00795210|143376571|SUPERIORITY_OR_OTHER|||||||0.42||95.0|||||ANOVA|||||||0.42
71927784|NCT03504839|143376573|SUPERIORITY||||||<|0.01|||||||ANOVA|||||||<0.01
71927785|NCT02074982|143376590|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.01|4.02|||Regression, Logistic|||||4.02|2.01|<0.0001
71927786|NCT00566969|143376608|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|A hierarchical linear model was used to account for unequal variance and covariance structures across time.||||||0.1|||||||ANOVA|||||||.10
71927787|NCT00471237|143376610|SUPERIORITY||Mean Difference (Net)|0.29|STANDARD_ERROR_OF_MEAN|0.55||0.59|TWO_SIDED|95.0|-0.78|1.37|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||1.37|-0.78|0.590
71927788|NCT00471237|143376610|SUPERIORITY||Mean Difference (Net)|1.36|STANDARD_ERROR_OF_MEAN|0.55||0.028|TWO_SIDED|95.0|0.28|2.44|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12||||2.44|0.28|0.028
71927789|NCT00471237|143376610|SUPERIORITY||Mean Difference (Net)|1.58|STANDARD_ERROR_OF_MEAN|0.54||0.011|TWO_SIDED|95.0|0.51|2.65|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.65|0.51|0.011
71927790|NCT00471237|143376610|SUPERIORITY||Mean Difference (Net)|1.6|STANDARD_ERROR_OF_MEAN|0.55||0.012|TWO_SIDED|95.0|0.51|2.69|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.044 at Month 12.||||2.69|0.51|0.012
71689761|NCT04208412|142895884|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
71689762|NCT04208412|142895885|SUPERIORITY||||||<|0.0001|||||||Wilcoxon Test (Gehan's Generalized)|||||||<0.0001
71689763|NCT05415462|142895891|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Geometric Mean Ratio (GMR)|1.01|||||TWO_SIDED|97.5|0.952|1.071||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||1.071|0.952|
71927791|NCT00471237|143376618|SUPERIORITY||Mean Difference (Net)|-0.45|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.38|0.48|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.48|-1.38|0.680
71927792|NCT00471237|143376618|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|0.48||0.192|TWO_SIDED|95.0|0.01|1.89|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.89|0.01|0.192
71927793|NCT00471237|143376618|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.47||0.68|TWO_SIDED|95.0|-1.12|0.73|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||0.73|-1.12|0.680
71927794|NCT00471237|143376618|SUPERIORITY||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.48||0.68|TWO_SIDED|95.0|-0.59|1.29|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was \<0.006 at Month 6.||||1.29|-0.59|0.680
71927795|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-0.68|STANDARD_ERROR_OF_MEAN|0.33||0.037|TWO_SIDED|95.0|-1.32|-0.04|||ANOVA|||Total Hip aBMD, Month 6||-0.04|-1.32|0.037
71927796|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-0.79|STANDARD_ERROR_OF_MEAN|0.33||0.017|TWO_SIDED|95.0|-1.43|-0.14|||ANOVA|||Total Hip aBMD, Month 6||-0.14|-1.43|0.017
71927797|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|0.32||0|TWO_SIDED|95.0|-1.92|-0.64|||ANOVA|||Total Hip aBMD, Month 6||-0.64|-1.92|0.000
71927798|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.33||0|TWO_SIDED|95.0|-1.95|-0.65|||ANOVA|||Total Hip aBMD, Month 6||-0.65|-1.95|0.000
71927799|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|0.36||0.015|TWO_SIDED|95.0|-1.61|-0.17|||ANOVA|||Total Hip aBMD, Month 12||-0.17|-1.61|0.015
71927800|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-1.02|STANDARD_ERROR_OF_MEAN|0.37||0.006|TWO_SIDED|95.0|-1.74|-0.3|||ANOVA|||Total Hip aBMD, Month 12||-0.30|-1.74|0.006
71927801|NCT00471237|143376619|SUPERIORITY||Mean Difference (Net)|-1.33|STANDARD_ERROR_OF_MEAN|0.36||0|TWO_SIDED|95.0|-2.04|-0.63|||ANOVA|||Total Hip aBMD, Month 12||-0.63|-2.04|0.000
71927802|NCT00471237|143376619|SUPERIORITY||Median Difference (Net)|-1.57|STANDARD_ERROR_OF_MEAN|0.37||0|TWO_SIDED|95.0|-2.3|-0.84|||ANOVA|||Total Hip aBMD, Month 12||-0.84|-2.30|0.000
71927803|NCT03112720|143376634|OTHER||Odds Ratio (OR)|1.5|||<|0.01|TWO_SIDED||||||Chi-squared||||\< 0.01 study terminated because of covid and no meaningfull numbers participated|||<0.01
71927804|NCT02684370|143376638|OTHER||adjusted difference in percentage|70.3|||<|0.001|TWO_SIDED|95.0|64.0|76.7||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to tumor necrosis factor \[TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||76.7|64.0|<0.001
71927805|NCT02684370|143376639|OTHER||adjusted difference in percentage|79.9|||<|0.001|TWO_SIDED|95.0|73.5|86.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.3|73.5|<0.001
71927806|NCT02684370|143376640|OTHER||adjusted difference in percentage|34.7|||<|0.001|TWO_SIDED|95.0|28.6|40.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||40.8|28.6|<0.001
71927807|NCT02684370|143376641|OTHER||adjusted difference in percentage|35.5|||<|0.001|TWO_SIDED|95.0|30.0|41.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||41.0|30.0|< 0.001
71927808|NCT02684370|143376642|OTHER||adjusted difference in percentage|57.9|||<|0.001|TWO_SIDED|95.0|50.4|65.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||65.3|50.4|< 0.001
71927809|NCT02684370|143376643|OTHER||adjusted difference in percentage|27.1|||<|0.001|TWO_SIDED|95.0|21.2|32.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.9|21.2|< 0.001
71927810|NCT02684370|143376644|OTHER||adjusted difference in percentage|33.5|||<|0.001|TWO_SIDED|95.0|22.7|44.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.3|22.7|< 0.001
71927811|NCT02684370|143376645|OTHER||adjusted difference in percentage|25.1|||<|0.001|TWO_SIDED|95.0|15.2|35.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||35.0|15.2|< 0.001
71927812|NCT02684370|143376646|OTHER||adjusted difference in percentage|23.8|||<|0.001|TWO_SIDED|95.0|15.5|32.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||32.1|15.5|< 0.001
71927813|NCT02684370|143376647|OTHER||adjusted difference in percentage|22.9|||<|0.001|TWO_SIDED|95.0|14.3|31.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||31.6|14.3|< 0.001
71927814|NCT02684370|143376648|OTHER||adjusted difference in percentage|38.3|||<|0.001|TWO_SIDED|95.0|27.9|48.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||48.6|27.9|< 0.001
71927815|NCT02684370|143376649|OTHER||adjusted difference in percentage|35.1|||<|0.001|TWO_SIDED|95.0|25.7|44.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||44.6|25.7|< 0.001
71927816|NCT02684370|143376650|OTHER||adjusted difference in percentage|36.5|||<|0.001|TWO_SIDED|95.0|27.0|45.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||45.9|27.0|< 0.001
71927817|NCT02684370|143376651|OTHER||adjusted difference in percentage|17.0|||<|0.001|TWO_SIDED|95.0|7.4|26.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||26.6|7.4|< 0.001
71927818|NCT02684370|143376652|OTHER||adjusted difference in percentage|17.3|||<|0.001|TWO_SIDED|95.0|7.3|27.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||27.3|7.3|< 0.001
71927819|NCT02684370|143376653|OTHER||adjusted difference in percentage|23.0|||<|0.001|TWO_SIDED|95.0|11.9|34.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight \[≤100 kg vs \>100 kg\] and prior exposure to TNF\] antagonists \[0 vs ≥1\]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||34.0|11.9|< 0.001
71927820|NCT02684370|143376654|OTHER||Mean Difference (Final Values)|-5.765|||<|0.001|TWO_SIDED|95.0|-6.496|-5.035|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs \>100 kg) and prior exposure to TNF antagonists (0 vs ≥1).||-5.035|-6.496|<0.001
71927821|NCT04221373|143376655|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 117.78||SCIM Total Score||||<0.01
71927822|NCT04221373|143376655|OTHER|Mixed-effects model||||||0.03||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.59||SCIM Total Score||||0.03
71927823|NCT04221373|143376655|OTHER|Mixed-effects model||||||0.01||||||treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.02||SCIM R \& S scores||||0.01
71927824|NCT04221373|143376655|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 72.49||SCIM R \& S scores||||< 0.01
71927825|NCT04221373|143376656|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 5.82||LEMS||||0.02
71927826|NCT04221373|143376656|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 33.29||LEMS||||<0.01
71927827|NCT04221373|143376656|OTHER|Mixed-effects model||||||0.04||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 4.58||UEMS||||0.04
71927828|NCT04221373|143376656|OTHER|Mixed-effects model|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1, 26) = 15.34||UEMS||||<0.01
71927829|NCT04221373|143376656|OTHER|Mixed-effects model|||||<|0.01||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,26) = 8.06||TMS||||<0.01
71927830|NCT04221373|143376656|OTHER|TMS|||||<|0.01||||||Main effect of time|Mixed Models Analysis|F(1,26) = 38.91||||||<0.01
71927831|NCT04221373|143376656|OTHER|Mixed-effects model||||||0.02||||||Treatment group by time interaction effects|Mixed Models Analysis|F(1,21.7) = 6.23||TLTS||||0.02
71927832|NCT04221373|143376656|OTHER|Mixed-effects model||||||0.05||||||Main effect of time|Mixed Models Analysis|F(1 26)=4.14||TLTS||||0.05
71927833|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.485||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.51||Average worst pain intensity||||0.485
71927834|NCT04221373|143376657|OTHER|Mixed-effects model||||||0||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 26.71||Average worst pain intensity||||0.000
71927835|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.832||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 21) = 0.05||Worst pain interference with day-to-day activities||||0.832
71927836|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.033||||||Main effect of time|Mixed Models Analysis|F(1, 21) = 5.21||Worst pain interference with day-to-day activities||||0.033
71927837|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.692||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1, 42) = 0.16||Worst pain interference with overall mood||||0.692
71927838|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.005||||||Main effect of time|Mixed Models Analysis|F(1, 42) = 8.65||Worst pain interference with overall mood||||0.005
71927839|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.946||||||Treatment group-by-time interaction effect|Mixed Models Analysis|F(1,21) = 0.01||Worst pain interfered with sleep||||0.946
71927840|NCT04221373|143376657|OTHER|Mixed-effects model||||||0.0002||||||Main effect of time|Mixed Models Analysis|F(1,21) = 11.94||Worst pain interference with sleep||||0.0002
71927841|NCT04221373|143376658|SUPERIORITY|||||||0.554|||||||Chi-squared|X\^2 (1, N = 23) = 0.35||Baseline||||0.554
71927842|NCT04221373|143376658|SUPERIORITY|||||||0.949|||||||Chi-squared|X\^2 (1, N = 23) = 0.004||discharge from acute inpatient rehabilitation (average 2-3 weeks)||||0.949
71927843|NCT00627094|143376684|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0438|TWO_SIDED|95.0|1.02|2.96||In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.|Chi-squared|Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis||The null hypothesis to be tested was that the distributions of categorical responses were the same.||2.96|1.02|0.0438
71927844|NCT01828164|143376688|SUPERIORITY_OR_OTHER||Percent Change|29.0||||0.0164|TWO_SIDED||||||t-test, 1 sided||Percent change in tooth movement rate on the treatment side as compared to the control side.|||||0.0164
71927845|NCT01828164|143376689|SUPERIORITY_OR_OTHER||Percent change|220.8||||0.0423|TWO_SIDED||||||t-test, 1 sided||Percent change in root resorption rate on the control side as compared to the treatment side.|||||0.0423
71927846|NCT01828164|143376690|NON_INFERIORITY|1 point on the 10-point pain scale was used as the non-inferiority margin.|||||<|0.001|||||||Bootstrapped mean difference|This test bootstrapped the mean difference (Treatment Arm - Control Arm) less 1, the non-inferiority margin, 1000 times.||||||<0.001
71927847|NCT04983589|143376699|SUPERIORITY||Percentage Difference|27.3|||<|0.0001|TWO_SIDED|95.0|17.3|37.4||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||37.4|17.3|<0.0001
71927848|NCT04983589|143376700|SUPERIORITY||Percentage Difference|26.4|||<|0.0001|TWO_SIDED|95.0|16.8|36.0||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation based on pooled variance without continuity correction.|||36.0|16.8|<0.0001
71927849|NCT04983589|143376701|SUPERIORITY||Percentage Difference|34.7|||<|0.0001|TWO_SIDED|95.0|22.7|46.7||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated based on the normal approximation using pooled variance without continuity correction.|||46.7|22.7|<0.0001
71927850|NCT04983589|143376702|SUPERIORITY||Percentage Difference|20.6||||0.001|TWO_SIDED|95.0|8.6|32.6||Analysis was done using chi-square test.|Chi-squared||The 95% confidence interval for the proportion differences was calculated using the normal approximation using pooled variance without continuity correction.|||32.6|8.6|0.001
71927851|NCT00761969|143376703|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||Log Rank|||Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression - the outcome being the number of events per person-year.||||<0.001
71927852|NCT01040624|143376705|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|||||||Chi-squared|One-sided binomial test of univariate probability distributions||||||<0.0001
71927853|NCT01353586|143376709|SUPERIORITY_OR_OTHER||Proportion of events|71.6|||||TWO_SIDED|95.0|63.3|79.8|||||The above supplemental analysis is to estimate the rate of subjects without documented symptomatic AF at Day 240 using the Kaplan-Meier time-to-event analysis method to accommodate the censored information from the two withdrawn subjects.|||79.8|63.3|
71927854|NCT00978120|143376717|SUPERIORITY_OR_OTHER|||||||0.014|||||||Fisher Exact|||||||0.014
71927855|NCT00978120|143376718|SUPERIORITY_OR_OTHER|||||||0.05|||||||Fisher Exact|||||||0.05
71927856|NCT00978120|143376721|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||||||0.470
71927857|NCT00978120|143376722|SUPERIORITY_OR_OTHER|||||||0.12|||||||Fisher Exact|||||||0.120
71927858|NCT00978120|143376723|SUPERIORITY_OR_OTHER|||||||0.284|||||||Fisher Exact|||||||0.284
71927859|NCT00978120|143376724|SUPERIORITY_OR_OTHER|||||||0.004|||||||Fisher Exact|||||||0.004
71927860|NCT00978120|143376725|SUPERIORITY_OR_OTHER|||||||0.341|||||||Fisher Exact|||||||0.341
71927861|NCT00978120|143376726|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.020
71927862|NCT00978120|143376727|SUPERIORITY_OR_OTHER|||||||0.245|||||||Fisher Exact|||||||0.245
71927863|NCT00978120|143376728|SUPERIORITY_OR_OTHER|||||||0.173|||||||Fisher Exact|||||||0.173
71927864|NCT00978120|143376729|SUPERIORITY_OR_OTHER|||||||0.362|||||||Fisher Exact|||||||0.362
71927865|NCT00978120|143376730|SUPERIORITY_OR_OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
71927866|NCT00978120|143376731|SUPERIORITY_OR_OTHER|||||||0.016|||||||Fisher Exact|||||||0.016
71927867|NCT00978120|143376732|SUPERIORITY_OR_OTHER|||||||0.032|||||||Fisher Exact|||||||0.032
71927868|NCT01068418|143376735|SUPERIORITY_OR_OTHER||||||<|0.05||||||Threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the mean arterial pressure (mean of five measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.05
71927869|NCT01068418|143376736|SUPERIORITY_OR_OTHER||||||<|0.01||||||threshold for significance was P\<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the renal plasma flow (mean of three measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.||||<0.01
71927870|NCT03155269|143376743|OTHER||Mean Difference (Final Values)|-0.0423||||0.1324|TWO_SIDED|97.5|-0.1057|0.0211||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.0211|-0.1057|0.1324
71927871|NCT03155269|143376744|OTHER||Mean Difference (Final Values)|0.229||||0.0469|TWO_SIDED|97.5|-0.03|0.489||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.|||0.489|-0.030|0.0469
71927872|NCT03056456|143376762|SUPERIORITY||Ratio of Geometric LS Means|1.0|||||TWO_SIDED|90.0|0.81|1.23||||||Day 1||1.23|0.810|
71927873|NCT03056456|143376762|SUPERIORITY||Ratio of Geometric LS Means|1.01|||||TWO_SIDED|90.0|0.817|1.25||||||Day 3||1.25|0.817|
71927874|NCT03056456|143376763|SUPERIORITY||Ratio of Geometric LS Means|1.03|||||TWO_SIDED|90.0|0.808|1.31||||||Day 1||1.31|0.808|
71927875|NCT03056456|143376763|SUPERIORITY|Day 3|Ratio of Geometric LS Means|1.04|||||TWO_SIDED|90.0|0.82|1.32||||||||1.32|0.820|
71927876|NCT03733301|143376766|SUPERIORITY||Odds Ratio (OR)|1.88||||0.082|TWO_SIDED|95.0|0.92|3.85|||Regression, Logistic|||||3.85|0.92|0.082
71927877|NCT03733301|143376766|SUPERIORITY||Odds Ratio (OR)|2.77||||0.004|TWO_SIDED|95.0|1.38|5.56|||Regression, Logistic|||||5.56|1.38|0.004
71927878|NCT03733301|143376767|SUPERIORITY||Odds Ratio (OR)|2.62||||0.002|TWO_SIDED|95.0|1.44|4.76|||Regression, Logistic|||||4.76|1.44|0.002
71927879|NCT03733301|143376767|SUPERIORITY||Odds Ratio (OR)|3.27|||<|0.001|TWO_SIDED|95.0|1.8|5.97|||Regression, Logistic|||||5.97|1.80|< 0.001
71927880|NCT03733301|143376768|SUPERIORITY||Odds Ratio (OR)|1.24||||0.574|TWO_SIDED|95.0|0.59|2.62|||Regression, Logistic|||||2.62|0.59|0.574
71927881|NCT03733301|143376768|SUPERIORITY||Odds Ratio (OR)|2.07||||0.045|TWO_SIDED|95.0|1.02|4.2|||Regression, Logistic|||||4.20|1.02|0.045
71927882|NCT03733301|143376769|SUPERIORITY||Mean Difference (Final Values)|-13.08|STANDARD_ERROR_OF_MEAN|5.256||0.013|TWO_SIDED|95.0|-23.42|-2.73|||Mixed Models Analysis|||||-2.73|-23.42|0.013
71927883|NCT03733301|143376769|SUPERIORITY||Mean Difference (Final Values)|-22.13|STANDARD_ERROR_OF_MEAN|5.259|<|0.001|TWO_SIDED|95.0|-32.48|-11.78|||Mixed Models Analysis|||||-11.78|-32.48|<0.001
71927884|NCT03733301|143376770|SUPERIORITY||Odds Ratio (OR)|1.53||||0.364|TWO_SIDED|95.0|0.61|3.81|||Regression, Logistic|||||3.81|0.61|0.364
71927885|NCT03733301|143376770|SUPERIORITY||Odds Ratio (OR)|2.7||||0.022|TWO_SIDED|95.0|1.15|6.34|||Regression, Logistic|||||6.34|1.15|0.022
71927886|NCT03733301|143376771|SUPERIORITY||Odds Ratio (OR)|2.88||||0.002|TWO_SIDED|95.0|1.48|5.61|||Regression, Logistic|||||5.61|1.48|0.002
71927887|NCT03733301|143376771|SUPERIORITY||Odds Ratio (OR)|3.84|||<|0.001|TWO_SIDED|95.0|1.98|7.46|||Regression, Logistic|||||7.46|1.98|<0.001
71927888|NCT03733301|143376772|SUPERIORITY||Mean Difference (Final Values)|-0.82|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.23|-0.41|||Mixed Models Analysis|||||-0.41|-1.23|<0.001
71927889|NCT03733301|143376772|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|0.209|<|0.001|TWO_SIDED|95.0|-1.33|-0.51|||Mixed Models Analysis|||||-0.51|-1.33|<0.001
71927890|NCT03733301|143376773|SUPERIORITY||Mean Difference (Final Values)|-1.15|STANDARD_ERROR_OF_MEAN|0.319|<|0.001|TWO_SIDED|95.0|-1.78|-0.52|||Mixed Models Analysis|||||-0.52|-1.78|<0.001
71927891|NCT03733301|143376773|SUPERIORITY||Mean Difference (Final Values)|-1.66|STANDARD_ERROR_OF_MEAN|0.322|<|0.001|TWO_SIDED|95.0|-2.3|-1.3|||Mixed Models Analysis|||||-1.30|-2.30|<0.001
71927892|NCT03733301|143376774|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.001|TWO_SIDED|95.0|1.47|4.49|||Regression, Logistic|||||4.49|1.47|<0.001
71927893|NCT03733301|143376774|SUPERIORITY||Odds Ratio (OR)|3.56|||<|0.001|TWO_SIDED|95.0|2.0|6.32|||Regression, Logistic|||||6.32|2.00|<0.001
71927894|NCT03733301|143376775|SUPERIORITY||Odds Ratio (OR)|1.3||||0.715|TWO_SIDED|95.0|0.32|5.31|||Regression, Logistic|||||5.31|0.32|0.715
71927895|NCT03733301|143376775|SUPERIORITY||Odds Ratio (OR)|3.02||||0.083|TWO_SIDED|95.0|0.86|10.56|||Regression, Logistic|||||10.56|0.86|0.083
71927896|NCT03733301|143376776|SUPERIORITY||Mean Difference (Final Values)|-8.48|STANDARD_ERROR_OF_MEAN|2.663||0.002|TWO_SIDED|95.0|-13.72|-3.24|||Mixed Models Analysis|||||-3.24|-13.72|0.002
71927897|NCT03733301|143376776|SUPERIORITY||Mean Difference (Final Values)|-14.38|STANDARD_ERROR_OF_MEAN|2.662|<|0.001|TWO_SIDED|95.0|-19.62|-9.14|||Mixed Models Analysis|||||-9.14|-19.62|<0.001
71927898|NCT03733301|143376777|SUPERIORITY||Odds Ratio (OR)|3.21||||0.204|TWO_SIDED|95.0|0.53|19.37|||Regression, Logistic|||||19.37|0.53|0.204
71927899|NCT03733301|143376777|SUPERIORITY||Odds Ratio (OR)|6.99||||0.025|TWO_SIDED|95.0|1.27|38.53|||Regression, Logistic|||||38.53|1.27|0.025
71927900|NCT03733301|143376778|SUPERIORITY||Mean Difference (Final Values)|-8.97|STANDARD_ERROR_OF_MEAN|2.591|<|0.001|TWO_SIDED|95.0|-14.07|-3.87|||Mixed Models Analysis|||||-3.87|-14.07|<0.001
71927901|NCT03733301|143376778|SUPERIORITY||Mean Difference (Final Values)|-11.69|STANDARD_ERROR_OF_MEAN|2.584|<|0.001|TWO_SIDED|95.0|-16.78|-6.61|||Mixed Models Analysis|||||-6.61|-16.78|<0.001
71927902|NCT03733301|143376779|SUPERIORITY|||||||0.721|||||||Fisher Exact|||||||0.721
71927903|NCT03733301|143376779|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71927904|NCT03733301|143376780|SUPERIORITY||Mean Difference (Final Values)|-65.16|STANDARD_ERROR_OF_MEAN|24.149||0.0073|TWO_SIDED|95.0|-112.87|-17.65|||ANOVA|||||-17.65|-112.87|0.0073
71927905|NCT03733301|143376780|SUPERIORITY||Mean Difference (Final Values)|-91.14|STANDARD_ERROR_OF_MEAN|24.038||0.0002|TWO_SIDED|95.0|-138.43|-43.85|||ANOVA|||||-43.85|-138.43|0.0002
71927906|NCT03733301|143376781|SUPERIORITY||Mean Difference (Final Values)|-16.44|STANDARD_ERROR_OF_MEAN|4.658|<|0.001|TWO_SIDED|95.0|-25.6|-7.27|||Mixed Models Analysis|||||-7.27|-25.60|< 0.001
71927907|NCT03733301|143376781|SUPERIORITY||Mean Difference (Final Values)|-24.22|STANDARD_ERROR_OF_MEAN|4.672|<|0.001|TWO_SIDED|95.0|-33.42|-15.03|||Mixed Models Analysis|||||-15.03|-33.42|< 0.001
71927908|NCT03733301|143376782|SUPERIORITY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|1.046||0.006|TWO_SIDED|95.0|-4.96|-0.84|||Mixed Models Analysis|||||-0.84|-4.96|0.006
71927909|NCT03733301|143376782|SUPERIORITY||Mean Difference (Final Values)|-5.23|STANDARD_ERROR_OF_MEAN|1.043|<|0.001|TWO_SIDED|95.0|-7.28|-3.18|||Mixed Models Analysis|||||-3.18|-7.28|< 0.001
71927910|NCT03733301|143376783|SUPERIORITY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13||0.005|TWO_SIDED|95.0|-0.63|-0.12|||Mixed Models Analysis|||||-0.12|-0.63|0.005
71927911|NCT03733301|143376783|SUPERIORITY||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|95.0|-0.75|-0.24|||Mixed Models Analysis|||||-0.24|-0.75|< 0.001
71927912|NCT03733301|143376784|SUPERIORITY||Mean Difference (Final Values)|-0.74|STANDARD_ERROR_OF_MEAN|0.425||0.083|TWO_SIDED|95.0|-1.57|0.1|||Mixed Models Analysis|||HADS Depression||0.10|-1.57|0.083
71927913|NCT03733301|143376784|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.423||0.016|TWO_SIDED|95.0|-1.85|-0.19|||Mixed Models Analysis|||HADS Depression||-0.19|-1.85|0.016
71927914|NCT03733301|143376784|SUPERIORITY||Mean Difference (Final Values)|-0.81|STANDARD_ERROR_OF_MEAN|0.415||0.051|TWO_SIDED|95.0|-1.63|0.0|||Mixed Models Analysis|||HADS Anxiety||0.00|-1.63|0.051
71927915|NCT03733301|143376784|SUPERIORITY||Mean Difference (Final Values)|-0.91|STANDARD_ERROR_OF_MEAN|0.413||0.028|TWO_SIDED|95.0|-1.72|-0.1|||Mixed Models Analysis|||HADS Anxiety||-0.10|-1.72|0.028
71927916|NCT03733301|143376785|SUPERIORITY||Mean Difference (Final Values)|-1.92|STANDARD_ERROR_OF_MEAN|0.832||0.022|TWO_SIDED|95.0|-3.56|-0.28|||Mixed Models Analysis|||||-0.28|-3.56|0.022
71927917|NCT03733301|143376785|SUPERIORITY||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|0.829|<|0.001|TWO_SIDED|95.0|-4.94|-1.68|||Mixed Models Analysis|||||-1.68|-4.94|< 0.001
71927918|NCT03733301|143376786|SUPERIORITY||Mean Difference (Final Values)|2.01|STANDARD_ERROR_OF_MEAN|2.569||0.435|TWO_SIDED|95.0|-3.06|7.08|||Mixed Models Analysis|||Absenteeism||7.08|-3.06|0.435
71927919|NCT03733301|143376786|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.569||0.706|TWO_SIDED|95.0|-4.1|6.04|||Mixed Models Analysis|||Absenteeism||6.04|-4.10|0.706
71927920|NCT03733301|143376786|SUPERIORITY|Presenteeism|Mean Difference (Final Values)|-8.12|STANDARD_ERROR_OF_MEAN|4.384||0.066|TWO_SIDED|95.0|-16.78|0.54|||Mixed Models Analysis|||||0.54|-16.78|0.066
71927921|NCT03733301|143376786|SUPERIORITY||Mean Difference (Final Values)|-10.73|STANDARD_ERROR_OF_MEAN|4.336||0.014|TWO_SIDED|95.0|-19.3|-2.17|||Mixed Models Analysis|||Presenteeism||-2.17|-19.30|0.014
71927922|NCT03733301|143376786|SUPERIORITY|Work Productivity Loss|Mean Difference (Final Values)|-7.93|STANDARD_ERROR_OF_MEAN|4.511||0.081|TWO_SIDED|95.0|-16.84|0.99|||Mixed Models Analysis|||||0.99|-16.84|0.081
71927923|NCT03733301|143376786|SUPERIORITY||Mean Difference (Final Values)|-10.71|STANDARD_ERROR_OF_MEAN|4.473||0.018|TWO_SIDED|95.0|-19.55|1.88|||Mixed Models Analysis|||Work productivity Loss||1.88|-19.55|0.018
71927924|NCT03733301|143376786|SUPERIORITY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|3.511||0.006|TWO_SIDED|95.0|-16.71|-2.89|||Mixed Models Analysis|||Activity Impairment||-2.89|-16.71|0.006
71927925|NCT03733301|143376786|SUPERIORITY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|3.5||0.003|TWO_SIDED|95.0|-17.39|-3.61|||Mixed Models Analysis|||Activity Impairment||-3.61|-17.39|0.003
71927926|NCT03733301|143376787|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.017||0.176|TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis|||Health State Index US||0.06|-0.01|0.176
71927927|NCT03733301|143376787|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.017||0.004|TWO_SIDED|95.0|0.02|0.09|||Mixed Models Analysis|||Health State Index US||0.09|0.02|0.004
71927928|NCT03733301|143376787|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.024||0.176|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||Health State Index UK||0.08|-0.01|0.176
71927929|NCT03733301|143376787|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.024||0.003|TWO_SIDED|95.0|0.02|0.12|||Mixed Models Analysis|||Health State Index UK||0.12|0.02|0.003
71927930|NCT03733301|143376788|SUPERIORITY||Mean Difference (Final Values)|4.12|STANDARD_ERROR_OF_MEAN|2.593||0.113|TWO_SIDED|95.0|-0.98|9.23|||Mixed Models Analysis|||||9.23|-0.98|0.113
71927931|NCT03733301|143376788|SUPERIORITY||Mean Difference (Final Values)|6.06|STANDARD_ERROR_OF_MEAN|2.592||0.02|TWO_SIDED|95.0|0.96|11.16|||Mixed Models Analysis|||||11.16|0.96|0.020
71927932|NCT03733301|143376789|SUPERIORITY||Mean Difference (Final Values)|10.04|STANDARD_ERROR_OF_MEAN|4.36||0.022|TWO_SIDED|95.0|1.46|18.36|||ANCOVA|||||18.36|1.46|0.022
71927933|NCT03733301|143376789|SUPERIORITY||Mean Difference (Final Values)|17.33|STANDARD_ERROR_OF_MEAN|4.34|<|0.001|TWO_SIDED|95.0|8.79|25.88|||ANCOVA|||||25.88|8.79|< 0.001
71927934|NCT03733301|143376790|SUPERIORITY||Odds Ratio (OR)|3.83||||0.006|TWO_SIDED|95.0|1.46|10.03|||Regression, Logistic|||||10.03|1.46|0.006
71927935|NCT03733301|143376790|SUPERIORITY||Odds Ratio (OR)|4.58||||0.002|TWO_SIDED|95.0|1.77|11.87|||Regression, Logistic|||||11.87|1.77|0.002
71927936|NCT00807040|143376806|OTHER|We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.||||0.18
71927937|NCT00807040|143376807|OTHER|We used the log-rank test to compare rates of death from baseline to 2 years.|Hazard Ratio (HR)|0.79||||0.39|TWO_SIDED|95.0|0.46|1.35|||Log Rank|||||1.35|0.46|0.39
71927938|NCT00769132|143376838|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Two treatments are comparable if the geometric mean ratio is contained within the interval \[0.50-2.00\].|Geometric least-squares mean ratio|1.12||||||90.0|0.9|1.38||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) \[Treatment A/B\] of the urine levels of 11-dTxB2 on Day 7.||1.38|0.9|
71927939|NCT00769132|143376838|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.07||||||||1.07|0.71|
71927940|NCT00769132|143376838|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.8||||||90.0|0.65|0.98||||||||0.98|0.65|
71927941|NCT00769132|143376838|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.89||||||90.0|0.72|1.09||||||||1.09|0.72|
71927942|NCT00769132|143376838|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.91||||||90.0|0.74|1.12||||||||1.12|0.74|
71927943|NCT00769132|143376838|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.02||||||90.0|0.83|1.25||||||||1.25|0.83|
71927944|NCT00769132|143376839|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|1.04||||||90.0|0.92|1.17||||||||1.17|0.92|
71927945|NCT00769132|143376839|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.9||||||90.0|0.8|1.01||||||||1.01|0.8|
71927946|NCT00769132|143376839|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.56||||||90.0|0.49|0.63||||||||0.63|0.49|
71927947|NCT00769132|143376839|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.58||||||90.0|0.51|0.65||||||||0.65|0.51|
71927948|NCT00769132|143376839|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.62||||||90.0|0.55|0.7||||||||0.7|0.55|
71927949|NCT00769132|143376839|SUPERIORITY_OR_OTHER_LEGACY||Geometric least-squares mean ratio|0.64||||||90.0|0.57|0.72||||||||0.72|0.57|
71927950|NCT02181075|143376884|SUPERIORITY|||||||0.024||||||Not adjusted for multiple comparisons. A priori threshold \< 0.05|t-test, 2 sided|95% confidence interval (CI)||A paired t-test was used for Part I (Arm 1) only. Analysis only applies to Part I (Arm 1) because only this study arm has matched Post-LTLD (i.e. post-drug alone) and Post-LTLD+FUS biopsy samples obtained from the same liver tumours before and after targeted drug delivery. In Part II of the study design in which drug delivery occurred completely non-invasively, no Post-LTLD tissue sample is obtained and only a single tumour biopsy is obtained following drug delivery (Post-LTLD+FUS).||||0.024
71927951|NCT03539952|143376931|NON_INFERIORITY|The primary efficacy analysis utilized the serum NCC values from all study visits that were analyzed using a restricted maximum likelihood based general linear model for correlated data. The correlation due to repeated measures was modeled by specifying the variance covariance matrix. Considering a comparison of means in both treatment arms (D-penicillamine minus TETA 4HCl) at the 1-sided 2.5% level of Type 1 error, a non-inferiority margin of 50 μg/L was used.|Mean Difference (Final Values)|-9.2|STANDARD_ERROR_OF_MEAN|7.49|||TWO_SIDED|||||||||The primary endpoint was the assessment of the non-inferiority of TETA 4HCl in relation to D-penicillamine. The non-inferiority assessment was made on the basis of the mean serum NCC level at Week 36.||||
71927952|NCT00710840|143376936|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.||||0.07
71927953|NCT00710840|143376937|SUPERIORITY_OR_OTHER|||||||0.92|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.92
71927954|NCT00710840|143376938|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.48
71927955|NCT00710840|143376939|SUPERIORITY_OR_OTHER|||||||0.41|TWO_SIDED|||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||||||0.41
71927956|NCT00798707|143376951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.452|TWO_SIDED|95.0|-0.75|1.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||1.69|-0.75|0.452
71927957|NCT00798707|143376951|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.016|TWO_SIDED|95.0|0.28|2.72||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.||2.72|0.28|0.016
71689764|NCT05415462|142895891|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|GMR|1.657|||||TWO_SIDED|97.5|1.562|1.757||||||GMR (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||1.757|1.562|
71927958|NCT00798707|143376952|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.160
71927959|NCT00798707|143376952|SUPERIORITY_OR_OTHER|||||||0.028|TWO_SIDED|||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of 'Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.||||0.028
71927960|NCT00798707|143376953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.066|TWO_SIDED|95.0|-0.01|0.39|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.39|-0.01|0.066
71927961|NCT00798707|143376953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.038|TWO_SIDED|95.0|0.01|0.41|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.41|0.01|0.038
71927962|NCT00798707|143376954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.0||||0.242|TWO_SIDED|95.0|-0.68|2.68|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||2.68|-0.68|0.242
71927963|NCT00798707|143376954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.06||||0.016|TWO_SIDED|95.0|0.39|3.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||3.73|0.39|0.016
71927964|NCT00798707|143376955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.802|TWO_SIDED|95.0|-0.62|0.8|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.80|-0.62|0.802
71927965|NCT00798707|143376955|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.72||||0.048|TWO_SIDED|95.0|0.01|1.43|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||1.43|0.01|0.048
71927966|NCT00798707|143376956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.363||||0.1099|TWO_SIDED|95.0|0.93|1.99|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.99|0.93|0.1099
71927967|NCT00798707|143376956|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.591||||0.0154|TWO_SIDED|95.0|1.09|2.32|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.32|1.09|0.0154
71927968|NCT00798707|143376957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.878||||0.5929|TWO_SIDED|95.0|0.54|1.41|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||1.41|0.54|0.5929
71927969|NCT00798707|143376957|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.474||||0.0852|TWO_SIDED|95.0|0.95|2.29|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.||2.29|0.95|0.0852
71927970|NCT00798707|143376958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.277||||0.2232|TWO_SIDED|95.0|0.86|1.89|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||1.89|0.86|0.2232
71927971|NCT00798707|143376958|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||0.0022|TWO_SIDED|95.0|1.24|2.69|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.||2.69|1.24|0.0022
71927972|NCT00798707|143376959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.158||||0.4313|TWO_SIDED|95.0|0.8|1.67|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.67|0.80|0.4313
71927973|NCT00798707|143376959|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.372||||0.0888|TWO_SIDED|95.0|0.95|1.97|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.||1.97|0.95|0.0888
71927974|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09||||0.073|TWO_SIDED|95.0|-0.1|2.29|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.29|-0.10|0.073
71927975|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.06||||0.078|TWO_SIDED|95.0|-0.12|2.24|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.||2.24|-0.12|0.078
71927976|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.176|TWO_SIDED|95.0|-0.13|0.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.73|-0.13|0.176
71927977|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.109|TWO_SIDED|95.0|-0.08|0.77|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.||0.77|-0.08|0.109
71927978|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.064|TWO_SIDED|95.0|-0.02|0.84|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.84|-0.02|0.064
71927979|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.35||||0.104|TWO_SIDED|95.0|-0.07|0.78|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.||0.78|-0.07|0.104
71927980|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.538|TWO_SIDED|95.0|-2.98|5.57|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.||5.57|-2.98|0.538
71927981|NCT00798707|143376961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.689|TWO_SIDED|95.0|-1.76|2.62|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score||2.62|-1.76|0.689
71927982|NCT00798707|143376962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.066|TWO_SIDED|95.0|-1.67|0.05|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.05|-1.67|0.066
71927983|NCT00798707|143376962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.15|TWO_SIDED|95.0|-1.48|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.||0.23|-1.48|0.150
71927984|NCT00798707|143376963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.951||||0.8758|TWO_SIDED|95.0|0.51|1.78|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||1.78|0.51|0.8758
71927985|NCT00798707|143376963|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.165||||0.6397|TWO_SIDED|95.0|0.61|2.21|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.||2.21|0.61|0.6397
71927986|NCT00798707|143376965|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
71927987|NCT00798707|143376965|SUPERIORITY_OR_OTHER|||||||0.847|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).||||0.847
71927988|NCT00798707|143376965|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
71927989|NCT00798707|143376965|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).||||0.720
71927990|NCT00798707|143376965|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
71927991|NCT00798707|143376965|SUPERIORITY_OR_OTHER|||||||0.72|TWO_SIDED||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).||||0.720
71927992|NCT00848965|143376999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.35|||TWO_SIDED|95.0|-2.08|-0.68|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.68|-2.08|
71927993|NCT00848965|143376999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55|STANDARD_ERROR_OF_MEAN|0.309|||TWO_SIDED|95.0|-2.16|-0.93|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-0.93|-2.16|
71927994|NCT00848965|143376999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72|STANDARD_ERROR_OF_MEAN|0.305|||TWO_SIDED|95.0|-2.33|-1.11|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.|||-1.11|-2.33|
71927995|NCT00848965|143376999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.351|||TWO_SIDED|95.0|-2.6|-1.19|||||Treatment difference is presented as the difference in the adjusted means for treatment versus placebo.|||-1.19|-2.60|
71927996|NCT02329834|143377017|EQUIVALENCE|90% Confidence Interval 80\<ratio of AUC\<125. The FDA guided Bioequivalence limit of 80 to 125% for the ratio of the product averages has been adopted for use of an average BE criterion.|% diff Geometric Least Squared Mean|99.5|||||TWO_SIDED|90.0|94.77|104.75||||||||104.75|94.77|
71927997|NCT02329834|143377018|OTHER||% Diff Geometric Least Squared Mean|99.65|||||TWO_SIDED|90.0|94.79|104.75||||||||104.75|94.79|
71927998|NCT01976104|143377035|SUPERIORITY||Difference of proportion versus placebo|33.7|||=|0.0006|TWO_SIDED|95.0|15.8|51.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||51.6|15.8|=0.0006
71927999|NCT01976104|143377035|SUPERIORITY||Difference of proportion versus placebo|54.6|||<|0.0001|TWO_SIDED|95.0|36.5|72.7|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.||72.7|36.5|<0.0001
71928000|NCT01976104|143377036|SUPERIORITY||Difference of proportion versus placebo|60.2|||<|0.0001|TWO_SIDED|95.0|46.8|73.5|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.||73.5|46.8|<0.0001
71928001|NCT01976104|143377036|SUPERIORITY||Difference of proportion versus placebo|53.7|||<|0.0001|TWO_SIDED|95.0|35.8|71.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups||71.6|35.8|<0.0001
71928002|NCT01976104|143377037|SUPERIORITY||Difference in change of platelet count|25.4|||<|0.0001|TWO_SIDED|95.0|19.5|32.0|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI|||32.0|19.5|<0.0001
71928003|NCT01976104|143377037|SUPERIORITY||Difference in change of platelet count|36.3|||<|0.0001|TWO_SIDED|95.0|25.5|45.5|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.|||45.5|25.5|<0.0001
71928004|NCT01353209|143377045|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.4
71928005|NCT01353209|143377046|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.7
71928006|NCT01353209|143377047|SUPERIORITY|||||||0.8|||||||Regression, Linear|Linear Mixed-Effects Model Adjusted for Sirolimus Use||||||0.8
71928007|NCT01353209|143377047|SUPERIORITY|||||||0.8|||||||Regression, Linear|||||||.8
71928008|NCT01353209|143377048|SUPERIORITY|||||||0.015|||||||Mixed Models Analysis|Linear Mixed-Effects Model Adjusted for Sirolimus Use. P value was obtained for testing zero slope for log(VEGF-D).||||||0.015
71928009|NCT01335620|143377052|SUPERIORITY|||||||0.018|||||||Regression, Logistic|||Compare baseline to 24 weeks||||0.018
71928010|NCT02951182|143377054|SUPERIORITY||Least Squares (LS) Mean Difference|8.6||||0.0016|TWO_SIDED|95.0|3.5|13.8|||Mixed-effects Model for Repeated Measure|||||13.8|3.5|0.0016
71928011|NCT02951182|143377054|SUPERIORITY||Least Squares (LS) Mean Difference|10.6||||0.0001|TWO_SIDED|95.0|5.5|15.8|||Mixed-effects Model for Repeated Measure|||||15.8|5.5|0.0001
71928012|NCT02951182|143377054|SUPERIORITY||Least Squares (LS) Mean Difference|12.0||||0.0001|TWO_SIDED|95.0|6.7|17.4|||Mixed-effects Model for Repeated Measure|||||17.4|6.7|0.0001
71928013|NCT02951182|143377055|SUPERIORITY||Least Squares (LS) Mean Difference|-22.3|||||TWO_SIDED|95.0|-32.1|-12.4||||||||-12.4|-32.1|
71928014|NCT02951182|143377055|SUPERIORITY||Least Squares (LS) Mean Difference|-34.7|||||TWO_SIDED|95.0|-44.7|-24.8||||||||-24.8|-44.7|
71928015|NCT02951182|143377055|SUPERIORITY||Least Squares (LS) Mean Difference|-33.4|||||TWO_SIDED|95.0|-48.5|-18.3||||||||-18.3|-48.5|
71928016|NCT02951182|143377056|SUPERIORITY||Least Squares (LS) Mean Difference|14.8|||||TWO_SIDED|95.0|5.3|24.2||||||||24.2|5.3|
71928017|NCT02951182|143377056|SUPERIORITY||Least Squares (LS) Mean Difference|19.1|||||TWO_SIDED|95.0|9.7|28.6||||||||28.6|9.7|
71928018|NCT02951182|143377056|SUPERIORITY||Least Squares (LS) Mean Difference|20.0|||||TWO_SIDED|95.0|10.8|29.1||||||||29.1|10.8|
71928019|NCT02951182|143377057|SUPERIORITY||Least Squares (LS) Mean Difference|16.1|||||TWO_SIDED|95.0|5.4|26.8||||||||26.8|5.4|
71928020|NCT02951182|143377057|SUPERIORITY||Least Squares (LS) Mean Difference|18.5|||||TWO_SIDED|95.0|7.9|29.1||||||||29.1|7.9|
71928021|NCT02951182|143377057|SUPERIORITY||Least Squares (LS) Mean Difference|20.2|||||TWO_SIDED|95.0|11.9|28.4||||||||28.4|11.9|
71928022|NCT03237325|143377154|SUPERIORITY|||||||0.1798|||||||Log Rank|||||||0.1798
71928023|NCT00561600|143377155|NON_INFERIORITY_OR_EQUIVALENCE|non inferiority of proportion successful with 8% non inferiority margin at 24 months|percentage difference|0.139||||0.872|ONE_SIDED|95.0||0.225|||Chi-squared||The upper confidence limit was a priori determined to be a secondary endpoint|A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt \< 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.||.225||0.872
71928024|NCT00561600|143377156|SUPERIORITY_OR_OTHER|||||||0.167||95.0|||||t-test, 2 sided|Satterthwaite||||||0.167
71928025|NCT00561600|143377159|SUPERIORITY_OR_OTHER|||||||0.457|||||||Wilcoxon (Mann-Whitney)|||||||0.457
71928026|NCT00561600|143377160|SUPERIORITY_OR_OTHER|||||||0.762|||||||Wilcoxon (Mann-Whitney)|||||||0.762
71928027|NCT00561600|143377161|SUPERIORITY_OR_OTHER|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||||||0.869
71928028|NCT00561600|143377162|SUPERIORITY_OR_OTHER|||||||0.799|||||||Wilcoxon (Mann-Whitney)|||||||0.799
71928029|NCT00561600|143377163|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||<0.001
71928030|NCT00561600|143377164|SUPERIORITY_OR_OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.032
71928031|NCT00561600|143377165|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||<0.001
71928032|NCT00561600|143377166|SUPERIORITY_OR_OTHER|||||||0.882|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.882
71928033|NCT00561600|143377167|SUPERIORITY_OR_OTHER|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.005
71928034|NCT00561600|143377168|SUPERIORITY_OR_OTHER|||||||0.237|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.237
71928035|NCT00561600|143377169|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
71928036|NCT00561600|143377170|SUPERIORITY_OR_OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.121
71928037|NCT00561600|143377171|SUPERIORITY_OR_OTHER|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group||||0.012
71928038|NCT00561600|143377172|SUPERIORITY_OR_OTHER|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.103
71928039|NCT00561600|143377173|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.001
71928040|NCT00561600|143377174|SUPERIORITY_OR_OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.300
71928041|NCT00561600|143377175|SUPERIORITY_OR_OTHER|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.079
71928042|NCT00561600|143377176|SUPERIORITY_OR_OTHER|||||||0.766|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.766
71928043|NCT00561600|143377177|SUPERIORITY_OR_OTHER|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.018
71928044|NCT00561600|143377178|SUPERIORITY_OR_OTHER|||||||0.689|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.689
71928045|NCT00561600|143377179|SUPERIORITY_OR_OTHER|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group||||0.048
71928046|NCT00561600|143377180|SUPERIORITY_OR_OTHER|||||||0.782|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group||||0.782
71928047|NCT00561600|143377181|SUPERIORITY_OR_OTHER|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group||||0.061
71928048|NCT00561600|143377182|SUPERIORITY_OR_OTHER|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group||||0.957
71928049|NCT02181673|143377195|SUPERIORITY_OR_OTHER||Percent Difference|53.4|||<|0.001|TWO_SIDED|95.0|45.8|60.9|||Cochran-Mantel-Haenszel|||||60.90|45.80|<0.001
71928050|NCT01354015|143377213|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.79||0.2539|TWO_SIDED|95.0|||||ANOVA|||All statistical analysis used intent-to-treat methodology and all comparisons used a two-tailed test at the .05 level of significance. Continuous variables are reported as means and standard deviations. W||||0.2539
71928051|NCT04637815|143377215|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables|||||||TWO_SIDED|0.0||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71928052|NCT04637815|143377216|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71928053|NCT04637815|143377217|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71928054|NCT04637815|143377218|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71928055|NCT04637815|143377219|EQUIVALENCE|t-tests for continuous variables and chi-squared tests for categorical variables||||||||||||Statistical threshold of significance is .05.|t-test, 2 sided||||We also conducted difference in differences (DID) analysis by first constructing measures of difference between follow-up and baseline for each participant for each measure and then comparing the means of these difference measures for each arm.|||
71928056|NCT00337727|143377220|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
71928057|NCT00337727|143377221|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic|||||||<0.01
71928058|NCT00577031|143377238|SUPERIORITY_OR_OTHER|||||||0.0076|||||||Signed-rank test|||Change from baseline to last visit||||0.0076
71928059|NCT06067191|143377239|OTHER||Difference in Least Square Mean|-312.28||||0.0009|TWO_SIDED|95.0|-489.17|-135.38|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-135.38|-489.17|0.0009
71928060|NCT06067191|143377240|OTHER||Difference in Least Square Mean|-1.45||||0.0047|TWO_SIDED|95.0|-2.43|-0.47|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-0.47|-2.43|0.0047
71928061|NCT06067191|143377241|OTHER||||||<|0.0001|||||||Log Rank|||||||<0.0001
71928062|NCT06067191|143377242|OTHER|||||||0.0051|||||||Log Rank|||||||0.0051
71928063|NCT06067191|143377243|OTHER|||||||0.0077|||||||Log Rank|||||||0.0077
71928064|NCT06067191|143377244|OTHER||Difference in Least Square Mean|-87.4||||0.0268|TWO_SIDED|95.0|-164.3|-10.49|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||-10.49|-164.30|0.0268
71928065|NCT06067191|143377245|OTHER||Difference in Least Square Mean|-0.99||||0.0865|TWO_SIDED|95.0|-2.13|0.15|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.15|-2.13|0.0865
71928066|NCT06067191|143377246|OTHER|||||||0.0008|||||||Log Rank|||||||0.0008
71928067|NCT06067191|143377247|OTHER|||||||0.8579|||||||Log Rank|||||||0.8579
71928068|NCT06067191|143377248|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
71928069|NCT06067191|143377249|OTHER||Difference in Least Square Mean|-93.95||||0.0658|TWO_SIDED|95.0|-194.26|6.36|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||6.36|-194.26|0.0658
71928070|NCT06067191|143377250|OTHER||Difference in Least Square Mean|-0.93||||0.203|TWO_SIDED|95.0|-2.38|0.52|||ANCOVA||Analysis was performed using ANCOVA with treatment group as a fixed effect and baseline viral load as the covariate.|||0.52|-2.38|0.2030
71928071|NCT04764669|143377269|SUPERIORITY|Primary comparisons were: DLB without amyloid copathology versus DLB with amyloid copathology|Least squares mean difference|-20.022|||||TWO_SIDED|95.0|-77.635|37.591||||||||37.591|-77.635|
71928072|NCT04764669|143377269|SUPERIORITY|Primary comparisons were: PDD without amyloid copathology versus PDD with amyloid copathology.|Least squares mean difference|-175.65|||||TWO_SIDED|95.0|-287.407|-63.893||||||||-63.893|-287.407|
71928073|NCT03992261|143377280|OTHER|"Mean, median, SD, minimum/maximum determined for total amount of test article used by each subject in Safety, Evaluable, and PK populations HPA Axis Suppression: Proportion of subjects manifesting laboratory evidence of adrenal suppression at EOS were presented with 95% confidence intervals (CIs) for Evaluable and Safety populations. Descriptive statistics for daily dose of test article were tabulated separately for suppressed and non-suppressed subjects.~PK: Screening, Day 8, Day 15"||||||0.05|||||||ANOVA|||Outcome measure: extent of exposure, HPA axis suppression, and pharmacokinetic analysis.||||0.05
71928074|NCT00877799|143377291|SUPERIORITY_OR_OTHER|||||||0.057|||||||t-test, 2 sided|||||||0.057
71928075|NCT00877799|143377292|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71928076|NCT00877799|143377293|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71928077|NCT01833897|143377319|SUPERIORITY_OR_OTHER||||||<|0.001||||||F1,6.4=161.8,|linear mixed model|||||||<0.001
71928078|NCT01833897|143377320|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71928079|NCT01833897|143377321|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||0.026
71928080|NCT01833897|143377322|SUPERIORITY_OR_OTHER|||||||0.011|||||||ANOVA|||||||0.011
71928081|NCT01833897|143377323|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71928082|NCT00127192|143377324|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.6|||<|0.001||95.0|-4.3|-3.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-3.0|-4.3|<0.001
71928083|NCT00127192|143377324|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.2|||<|0.001||95.0|-3.9|-2.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.6|-3.9|<0.001
71928084|NCT00127192|143377324|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-3.3|||<|0.001||95.0|-3.9|-2.7||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.7|-3.9|<0.001
71928085|NCT00127192|143377324|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-2.6|||<|0.001||95.0|-3.2|-2.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-2.0|-3.2|<0.001
71928086|NCT00127192|143377325|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Tukeys linear trend test based on ANCOVA|Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline||||||<0.001
71928087|NCT00127192|143377325|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-1.04|||<|0.001||95.0|-1.21|-0.86||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.86|-1.21|<0.001
71928088|NCT00127192|143377325|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.96|||<|0.001||95.0|-1.14|-0.79||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.79|-1.14|<0.001
71928089|NCT00127192|143377325|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.99|||<|0.001||95.0|-1.16|-0.82||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.82|-1.16|<0.001
71928090|NCT00127192|143377325|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-0.69|||<|0.001||95.0|-0.85|-0.52||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-0.52|-0.85|<0.001
71928091|NCT00127192|143377326|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-23.2|||<|0.001||95.0|-29.8|-16.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-16.6|-29.8|<0.001
71928092|NCT00127192|143377326|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-20.8|||<|0.001||95.0|-27.4|-14.3||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-14.3|-27.4|<0.001
71928093|NCT00127192|143377326|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-17.7|||<|0.001||95.0|-24.2|-11.2||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-11.2|-24.2|<0.001
71928094|NCT00127192|143377326|SUPERIORITY_OR_OTHER||Least-squares Mean Difference|-15.9|||<|0.001||95.0|-22.3|-9.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval|||-9.6|-22.3|<0.001
71928095|NCT00077766|143377338|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority with 90% power assuming that the true difference between the RO0503821 group and darbepoetin was not larger than 0.3 g/dL.|Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.1162|<|0.0001|TWO_SIDED|95.0|-0.049|0.408||The p-value for the non-inferiority test was derived using ANCOVA.|ANCOVA, CI for difference between groups|Degrees of Freedom : 246|Difference between groups based on the adjusted means derived from the ANCOVA model.|RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was \> or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.||0.408|-0.049|< 0.0001
71928096|NCT04150107|143377355|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|Least mean squares||||<|0.9223|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9223
71928097|NCT04150107|143377356|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.8871|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.8871
71928098|NCT04150107|143377357|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9641|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9641
71928099|NCT04150107|143377358|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.7922|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.7922
71928100|NCT04150107|143377359|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.9898|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.9898
71928101|NCT04150107|143377360|OTHER|Treatment least squares means and change from baseline estimates will be derived using this linear model.|||||<|0.5165|||||||ANCOVA|||Information collected in the daily diaries or via the Continuous Glucose Monitor (CGM) on the final 10 days of treatment will be analyzed using a Repeated Measures Analysis of Covariance with subject as a random effect with each of the 10 days being a single measurement. When analyzing the exogenous insulin variables, the CGM parameters (mean 24 hour glucose value and 24 hour time within 70-180 mg/dL range) and the patient reported carbohydrate intake will be included as covariates.||||<0.5165
71928102|NCT00379821|143377410|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0413|STANDARD_ERROR_OF_MEAN|0.1746||0.8097|TWO_SIDED|95.0|0.7497|1.4463||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4463|0.7497|0.8097
71928103|NCT00379821|143377410|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1623|STANDARD_ERROR_OF_MEAN|0.1973||0.3767|TWO_SIDED|95.0|0.8333|1.6211||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.6211|0.8333|0.3767
71928104|NCT00379821|143377410|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0707|STANDARD_ERROR_OF_MEAN|0.1795||0.6277|TWO_SIDED|95.0|0.7708|1.4872||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.||1.4872|0.7708|0.6277
71928105|NCT00379821|143377444|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96|STANDARD_ERROR_OF_MEAN|0.17||0.79|TWO_SIDED|95.0|0.68|1.34||Not adjusted, 0.05|Regression, Cox|There are no adjustments.|The reference category is those who did not travel.|||1.34|0.68|0.79
71928106|NCT04502862|143377453|OTHER||Least square mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.107||0.512|TWO_SIDED|95.0|-0.28|0.14||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, body mass index (BMI), region (Eastern Europe, rest of world \[ROW\]), inhaled corticosteroids \[ICS\] dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline asthma control questionnaire (ACQ-5), baseline sleep disturbance score and baseline-by-visit interaction as covariates.||0.14|-0.28|0.512
71928107|NCT04502862|143377454|OTHER||Least square mean difference|0.0|STANDARD_ERROR_OF_MEAN|0.11||0.967|TWO_SIDED|95.0|-0.21|0.22||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05.|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline number of nocturnal awakenings and baseline-by-visit interaction as covariates.||0.22|-0.21|0.967
71928108|NCT04502862|143377455|OTHER||Least square mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.865||0.422|TWO_SIDED|95.0|-2.4|1.01||A hierarchical testing procedure was used to control type I error and handle primary and first 2 secondary endpoints (reported sequentially) analyses at a 2-sided significance level of 0.05|MMRM|||The MMRM model included study intervention, age, BMI, region (Eastern Europe, ROW), ICS dose level at baseline (ICS dose level medium, ICS dose level high), visit (up to Week 12), study intervention-by-visit interaction, baseline ACQ-5, baseline PROMIS total score and baseline-by-visit interaction as covariates.||1.01|-2.40|0.422
71928109|NCT02087865|143377467|SUPERIORITY||Mean Difference (Final Values)|-8.25|STANDARD_ERROR_OF_MEAN|7.59||0.273|TWO_SIDED|95.0|-23.12|6.63|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||6.63|-23.12|0.273
71928110|NCT02087865|143377468|SUPERIORITY||Mean Difference (Final Values)|-13.41|STANDARD_ERROR_OF_MEAN|3.92||0.001|TWO_SIDED|95.0|-21.09|-5.73|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-5.73|-21.09|0.001
71928111|NCT02087865|143377469|SUPERIORITY||Median Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|5.48||0.115|TWO_SIDED|95.0|-19.33|2.14|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||2.14|-19.33|0.115
71928112|NCT02087865|143377470|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|2.09||0.941|TWO_SIDED|95.0|-3.94|4.25|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||4.25|-3.94|0.941
71928113|NCT02087865|143377471|SUPERIORITY||Mean Difference (Final Values)|46.33|STANDARD_ERROR_OF_MEAN|15.4||0.003|TWO_SIDED|95.0|16.14|76.53|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||76.53|16.14|0.003
71928114|NCT02087865|143377472|SUPERIORITY||Mean Difference (Final Values)|61.36|STANDARD_ERROR_OF_MEAN|13.32|<|0.001|TWO_SIDED|95.0|35.25|87.46|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||87.46|35.25|<0.001
71928115|NCT02087865|143377473|SUPERIORITY||Mean Difference (Final Values)|-3.35|STANDARD_ERROR_OF_MEAN|1.18||0.005|TWO_SIDED|95.0|-5.65|-1.04|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.04|-5.65|0.005
71928116|NCT02087865|143377474|SUPERIORITY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|1.67||0.011|TWO_SIDED|95.0|-7.58|-1.02|||ANCOVA|||We are reporting the difference in mean between the Donepezil HCL and Placebo groups.||-1.02|-7.58|0.011
71928117|NCT01392469|143377483|SUPERIORITY||Ratio (Test/Reference)|1.17|||||TWO_SIDED|90.0|1.03|1.33||||||||1.33|1.03|
71928118|NCT01392469|143377483|SUPERIORITY||Ratio (Test/Reference)|1.4|||||TWO_SIDED|90.0|1.23|1.59||||||||1.59|1.23|
71928119|NCT01392469|143377484|SUPERIORITY||Ratio (Test/Reference)|1.36|||||TWO_SIDED|90.0|1.14|1.62||||||||1.62|1.14|
71928120|NCT01392469|143377484|SUPERIORITY||Ratio (Test/Reference)|1.7|||||TWO_SIDED|90.0|1.43|2.03||||||||2.03|1.43|
71928121|NCT01392469|143377485|SUPERIORITY||Ratio (Test/Reference)|1.0|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
71928122|NCT01392469|143377485|SUPERIORITY||Ratio (Test/Reference)|1.07|||||TWO_SIDED|90.0|0.88|1.31||||||||1.31|0.88|
71928123|NCT01392469|143377486|SUPERIORITY||Ratio (Test/Reference)|1.28|||||TWO_SIDED|90.0|1.03|1.61||||||||1.61|1.03|
71928124|NCT01392469|143377486|SUPERIORITY||Ratio (Test/Reference)|1.56|||||TWO_SIDED|90.0|1.24|1.95||||||||1.95|1.24|
71928125|NCT00684645|143377537|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.395|||<|0.0001|TWO_SIDED|95.0|0.257|0.609|||Cox proportional hazard|||Time to PFS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.609|0.257|<0.0001
71928126|NCT00684645|143377538|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.361||||0.0221|TWO_SIDED|95.0|0.151|0.864|||Cox proportional hazard|||Time to OS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).||0.864|0.151|0.0221
71928127|NCT03126682|143377549|SUPERIORITY|||||||0.212||||||Threshold of \<0.05|t-test, 2 sided|||||||0.212
71928128|NCT02513095|143377560|SUPERIORITY||Odds Ratio (OR)|6.0||||0.396|TWO_SIDED|95.0|0.6|76.8|||Chi-squared, Corrected|||||76.8|0.6|0.396
71928129|NCT01441401|143377589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.045|||||||Fisher Exact|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no association between the baseline severity of epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."||||0.045
71689765|NCT05415462|142895891|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|GMR|0.665|||||TWO_SIDED|97.5|0.63|0.702||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Victoria Lineage||0.702|0.630|
71928130|NCT01441401|143377589|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Armitage (EXACT)|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the baseline severity of epileptic seizure (mild, moderate, and severe)."||||0.017
71928131|NCT01441401|143377590|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|||||||Fisher Exact|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."||||0.018
71928132|NCT01441401|143377591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.034|||||||Fisher Exact|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."||||0.034
71928133|NCT01441401|143377591|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Cochran-Armitage (EXACT)|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the increasing number of concomitant antiepileptic drugs at baseline."||||0.005
71928134|NCT01441401|143377592|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||"The factor tested was treatment period with gabapentin. The null hypothesis was that there was no association between the treatment period with gabapentin and the number of participants who responded to the treatment with gabapentin."||||<0.001
71928135|NCT03256526|143377598|SUPERIORITY||LS mean difference|11.45||||0.1654|TWO_SIDED|90.0|-2.19|25.09|||ANCOVA|||||25.09|-2.19|0.1654
71928136|NCT03256526|143377598|SUPERIORITY||LS mean difference|-18.73||||0.0395|TWO_SIDED|90.0|-33.55|-3.9|||ANCOVA|||||-3.90|-33.55|0.0395
71928137|NCT01607398|143377628|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-8.05||||0.5146|TWO_SIDED|95.0|-20.5|7.6|||Wilcoxon (Mann-Whitney)|The analysis was done using the Van Elteren extension to the Wilcoxon rank sum test.|From Van-Elteren extension to the Wilcoxon Rank Sum test, adjusted for smoking status strata and Hodges-Lehmann estimator of the 95% CI, not stratified and unadjusted for multiplicity.|||7.600|-20.500|0.5146
71928138|NCT00929201|143377672|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin \[i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.97||||||90.0|0.95|1.0||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||1.00|0.95|
71928139|NCT00929201|143377673|NON_INFERIORITY_OR_EQUIVALENCE|The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin \[i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)\].|Least-Squares Mean Ratio|0.95||||||90.0|0.93|0.98||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets||0.98|0.93|
71928140|NCT01299272|143377681|SUPERIORITY_OR_OTHER|||||||0.485|||||||Log Rank|||||||0.485
71928141|NCT00464308|143377710|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.11|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|Non-inferiority||Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71928142|NCT00464308|143377713|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.051|||<|0.05||95.0||||All statistical tests were interpreted at the 5% significance level (2-tailed).|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71928143|NCT00464308|143377714|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.053|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71928144|NCT00464308|143377715|NON_INFERIORITY_OR_EQUIVALENCE|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.061|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p\<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.||||<0.05
71928145|NCT03533608|143377745|OTHER|Descriptive|Mean Difference (Final Values)|19.51|||||TWO_SIDED|||||||||||||
71928146|NCT03533608|143377746|OTHER|Descriptive|Mean Difference (Final Values)|4.04|||||TWO_SIDED|||||||||||||
71928147|NCT01900392|143377775|OTHER||||||>|0.1|||||||Regression, Linear|||||||>0.1
71928148|NCT00826176|143377790|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|6.4||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
71928149|NCT00826176|143377790|SUPERIORITY_OR_OTHER||upper limit of tolerance interval (min.)|3.2||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.|||||
71928150|NCT00826176|143377790|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence between the two subject populations was to be claimed in the event that the two-sided 95% confidence interval was entirely within the interval ranging from -60 to +60 seconds.|median difference (seconds)|49.0||||||95.0|30.0|72.0|||||The estimated median difference (Chinese minus Caucasian) in time to recovery of the T4/T1 ratio to 0.9.|||72|30|
71928151|NCT01687400|143377793|OTHER|||||||0.035|||||||Fisher Exact|||Statistical analysis #1 is for the genetic mutation TP53.||||0.035
71928152|NCT01687400|143377793|OTHER|||||||0.72|||||||Fisher Exact|||Statistical analysis #2 is for ASXL1 genetic mutation||||0.72
71928153|NCT01687400|143377793|OTHER|||||||0.28|||||||Fisher Exact|||Statistical analysis #3 is for SRSF2 genetic mutation||||0.28
71689766|NCT05415462|142895891|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|GMR|0.661|||||TWO_SIDED|97.5|0.63|0.693||||||GMR (mRNA-1010 vs Fluarix) for Influenza B/ Yamagata Lineage||0.693|0.630|
71928154|NCT01687400|143377793|OTHER|||||||0.14|||||||Fisher Exact|||Statistical analysis #4 is for IDH2 genetic mutation||||0.14
71928155|NCT01687400|143377793|OTHER|||||||0.3|||||||Fisher Exact|||Statistical analysis #5 is for DNMT3A genetic mutation||||0.3
71928156|NCT01687400|143377793|OTHER|||||||0.183|||||||Fisher Exact|||Statistical analysis #6 is for SF3B1 genetic mutation||||0.183
71928157|NCT01687400|143377793|OTHER|||||||0.42|||||||Fisher Exact|||Statistical analysis #7 is for RUNX1 genetic mutation||||0.42
71928158|NCT01687400|143377793|OTHER|||||||0.36|||||||Fisher Exact|||Statistical analysis #8 is for TET2 genetic mutation||||0.36
71928159|NCT01687400|143377793|OTHER|||||||0.1|||||||Fisher Exact|||Statistical analysis #9 is for IDH1 genetic mutation||||0.1
71928160|NCT01687400|143377793|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #10 is for NPM1 genetic mutation||||1
71928161|NCT01687400|143377793|OTHER|||||||0.17|||||||Fisher Exact|||Statistical analysis #11 is for NRAS genetic mutation||||0.17
71928162|NCT01687400|143377793|OTHER|||||||1|||||||Fisher Exact|||-Statistical analysis #12 is for U2AF1 genetic mutation||||1
71928163|NCT01687400|143377793|OTHER|||||||0.6|||||||Fisher Exact|||Statistical analysis #13 is for MY05B genetic mutation||||0.6
71928164|NCT01687400|143377793|OTHER|||||||1|||||||Fisher Exact|||Statistical analysis #14 is for WT1 genetic mutation||||1
71928165|NCT01687400|143377794|SUPERIORITY||Overall Response Rate-for current study|0.744|||<|0.0001|TWO_SIDED|95.0|0.652|0.836|||Chi-squared|1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate||0.836|0.652|<0.0001
71928166|NCT01687400|143377794|SUPERIORITY||Complete response rate-for current study|0.64|||<|0.0001|TWO_SIDED|95.0|0.538|0.741|||Chi-squared|1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.||0.741|0.538|<0.0001
71689767|NCT05415462|142895892|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H1N1 strain at a 2-sided 0.025 level.|Percentage Difference|5.75|||||TWO_SIDED|97.5|3.12|8.38||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H1N1 Antibody||8.38|3.12|
71928167|NCT03731325|143377800|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.01|TWO_SIDED||||||ANOVA||This mean difference represents the main effect of time from baseline to 15 weeks, regardless of group|Change in parent BMI from baseline at 8,11 to 15 weeks||||<0.01
71928168|NCT03731325|143377801|SUPERIORITY||Mean Difference (Net)|-10.5||||0.003|TWO_SIDED|||||main effect of time|ANOVA||This is the main effect of weight change at week 15, e.g. average weight change from baseline to week 15 in the entire sample of parents|repeated measures analysis of variance for time (0,8,11,15 weeks) for weight change (lbs)||||0.003
71928169|NCT03731325|143377802|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.06|TWO_SIDED||||||ANOVA||average difference in BMI percentile for entire sample|Repeated measures ANOVA for child BMI percentile at 0, 8, 11 and 15 weeks||||0.06
71928170|NCT03731325|143377803|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.07|TWO_SIDED||||||ANOVA||average change in delay discounting measure area under the curve for all participants (parents and children) in both groups from baseline to week 15|repeated measures ANOVA, reporting repeated measures effect only||||0.07
71928171|NCT03731325|143377804|SUPERIORITY||Mean Difference (Net)|-0.8||||0.64|TWO_SIDED||||||ANOVA||Difference between weight at baseline and week 15 in lbs for all children, regardless of group|||||0.64
71928172|NCT00297882|143377810|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
71928173|NCT00297882|143377811|NON_INFERIORITY|Non-inferiority of AQ-AS compared to AL was assessed by constructing a one-sided, lower limit asymptotic 97.5% CI on the difference of polymerase chain reaction (PCR)-corrected cure rates of AQ-AS when compared to AL. Non-inferiority was declared if the lower limit of the CI was greater than -10% for AQ-AS.|||||>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Sample Size will be determined by N = {\[(Zα/2)/E\]\*2}pq where Where: n=sample size; Zα/2= Z value of a two-tailed test with 95% confidence level=1.96; p represents cure rate, q=1-p, which represents treatment failure rate of; E=precision of 5%||||>0.05
71928174|NCT04242264|143377813|SUPERIORITY|A two-sided Chi-squared test with alpha=0.05 was used to test the null hypothesis that the vaccine efficacy is zero, which is equivalent to testing that the relative risk of shigellosis is one.|Vaccine efficacy|0.89|||<|0.001|TWO_SIDED|95.0|0.71|0.96|||Chi-squared||Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate.|The null hypothesis is that the absolute vaccine efficacy (VE) of preventing shigellosis is zero. The alternative hypothesis is that the absolute VE is greater than zero.||0.96|0.71|<0.001
71928175|NCT04242264|143377814|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|0.77|||||TWO_SIDED|95.0|0.44|0.92||||||||0.92|0.44|
71928176|NCT04242264|143377814|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.78|1.0||||||||1.00|0.78|
71928177|NCT04242264|143377814|OTHER|Vaccine efficacy was calculated as 1 - relative risk of shigellosis, where relative risk = probability of shigellosis in WRSs2 group / probability of shigellosis in placebo group. A Wilson (Score) CI was calculated for the vaccine efficacy estimate, but no formal hypothesis test was performed.|Vaccine efficacy|1.0|||||TWO_SIDED|95.0|0.71|1.0||||||||1.00|0.71|
71928178|NCT04776135|143377839|OTHER|AUC0-t was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.987|||||TWO_SIDED|90.0|0.936|1.041|||ANOVA|||For AUC0-t, MT-1186 orally Versus MT-1186 via NGT||1.041|0.936|
71928179|NCT04776135|143377839|OTHER|AUC0-inf was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|0.981|||||TWO_SIDED|90.0|0.931|1.033|||ANOVA|||For AUC0-inf, MT-1186 orally Versus MT-1186 via NGT||1.033|0.931|
71928180|NCT04776135|143377840|OTHER|Cmax was log-transformed and analyzed by analysis of variance using administration groups, the administration route, study periods, and subjects as factors. Estimates of the mean values on the log scale, the mean difference between administration routes on the log scale, and 90% CIs for the difference were back transformed to present mean ratios and their 90% CIs for administration via NGT to oral administration.|Ratio (NGT/oral)|1.052|||||TWO_SIDED|90.0|0.903|1.227|||ANOVA|||MT-1186 orally Versus MT-1186 via NGT||1.227|0.903|
71928181|NCT01783860|143377849|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 1 sided|||||||0.03
71928182|NCT01783860|143377850|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||||||0.01
71928183|NCT01783860|143377851|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 1 sided|||||||0.007
71928184|NCT01783860|143377852|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 1 sided|||||||> 0.05
71928185|NCT01783860|143377853|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 1 sided|||||||0.02
71928186|NCT01783860|143377854|SUPERIORITY_OR_OTHER|||||||0.08||95.0|||||t-test, 1 sided|||||||0.08
71928187|NCT01139801|143377876|SUPERIORITY||Mean Difference (Final Values)|212.2||||0.037|TWO_SIDED|95.0|13.3|411.0|||t-test, 2 sided|||||411.0|13.3|0.037
71928188|NCT00741026|143377921|SUPERIORITY_OR_OTHER|||||||0.0203|||||||Wilcoxon Signed-rank|||||||0.0203
71928189|NCT00741026|143377922|SUPERIORITY_OR_OTHER|||||||0.0105|||||||Wilcoxon Sign-rank|||||||0.0105
71928190|NCT00741026|143377923|SUPERIORITY_OR_OTHER|||||||0.0166|||||||Wilcoxon Sign-rank|||||||0.0166
71928191|NCT00741026|143377924|SUPERIORITY_OR_OTHER|||||||0.0184|||||||Wilcoxon Sign-rank|||||||0.0184
71928192|NCT00741026|143377925|SUPERIORITY_OR_OTHER|||||||0.017|||||||Wilcoxon Sign-rank|||||||0.0170
71928193|NCT02712359|143377955|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 8 Group minus Havrix 2 doses\_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-23.33|||<|0.0001|TWO_SIDED|95.0|-28.78|-18.29|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.||-18.29|-28.78|<0.0001
71928194|NCT02712359|143377956|NON_INFERIORITY|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose\_Year 10 Group minus Havrix 2 doses\_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-24.43|||<|0.0001|TWO_SIDED|95.0|-30.11|-19.03|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose\_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses\_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.||-19.03|-30.11|<0.0001
71928195|NCT04139642|143377968|SUPERIORITY||||||<|0.0001||||||A mixed-effects model with provider as a random effect and month as a fixed effect was used to test the main effect of arm.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related diagnosis as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||<0.0001
71928196|NCT04139642|143377969|SUPERIORITY||||||=|0.15||||||Mixed-effects model with provider as a random effect and month as a fixed effect. Statistical significance a priori threshold set at 0.05.|Mixed Models Analysis|||The null hypothesis was that the rate of balance-related referral as a percentage of total visits would be the same between the historical control period, the active control (weight-only), and the intervention (balance+weight), considering provider and month as co-variates.||||=0.15
71928197|NCT00539006|143378006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|0.22|<|0.001||95.0|-1.5|-0.6|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo|FFNS combined across treatment arms 1 \& 2 compared with Placebo FFNS combined across treatment arms 1 \& 2.||-0.6|-1.5|<0.001
71928198|NCT00539006|143378006|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_ERROR_OF_MEAN|0.22||0.004||95.0|-1.1|-0.2|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo|FPNS combined across treatment arms 1 \& 2 compared with Placebo FPNS combined across treatment arms 1 \& 2.||-0.2|-1.1|0.004
71928199|NCT00539006|143378007|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximation to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||Statistical analysis applies to FFNS and FPNS categories.||||<0.001
71928200|NCT00258310|143378012|SUPERIORITY_OR_OTHER_LEGACY||proportion|0.74|||||TWO_SIDED|95.0|0.59|0.9||||||||.90|.59|
71928201|NCT00256217|143378016|OTHER||Mean Difference (Final Values)|4.9||||0.004|TWO_SIDED|95.0|1.8|8.0|||Wilcoxon (Mann-Whitney)|||||8.0|1.8|0.004
71928202|NCT00256217|143378017|OTHER||Mean Difference (Final Values)|0.3||||0.016|TWO_SIDED|95.0|0.1|0.49|||Wilcoxon (Mann-Whitney)|||||0.49|0.10|0.016
71928203|NCT03387267|143378029|OTHER||AUC under ROC curve|0.64|||||ONE_SIDED|95.0||0.72||||||||0.72||
71928204|NCT03387267|143378030|OTHER||AUC under ROC curve|0.65|||||TWO_SIDED|||||||||||||
71928205|NCT03387267|143378031|OTHER||AUC under ROC curve|0.576|||||TWO_SIDED|||||||||||||
71928206|NCT03159611|143378051|SUPERIORITY|||||||0.002|||||||Fisher Exact|||||||0.002
71928207|NCT03159611|143378052|SUPERIORITY|||||||0.005|||||||Cochran-Mantel-Haenszel|||||||0.005
71928208|NCT03159611|143378053|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
71928209|NCT03159611|143378054|SUPERIORITY|||||||0.2|||||||Cochran-Mantel-Haenszel|||||||0.20
71928210|NCT03159611|143378055|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||0.19
71928211|NCT01418365|143378070|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|0.979|||||TWO_SIDED|90.0|0.961|0.998|||ANOVA|||||0.998|0.961|
71928212|NCT01418365|143378071|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.993|||||TWO_SIDED|90.0|0.951|1.04|||ANOVA|||||1.04|0.951|
71928213|NCT03000075|143378074|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|73.6|||<|0.001|TWO_SIDED|95.0|62.2|85.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||85.0|62.2|< 0.001
71928214|NCT03000075|143378074|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|72.4|||<|0.001|TWO_SIDED|95.0|60.6|84.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||84.1|60.6|< 0.001
71928215|NCT03000075|143378076|OTHER||Adjusted percentage difference|75.0|||<|0.001|TWO_SIDED|95.0|63.8|86.2||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||86.2|63.8|< 0.001
71928216|NCT03000075|143378076|OTHER||Adjusted percentage difference|82.4|||<|0.001|TWO_SIDED|95.0|72.2|92.6||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||92.6|72.2|< 0.001
71928217|NCT03000075|143378078|OTHER||Adjusted percentage difference|80.3|||<|0.001|TWO_SIDED|95.0|70.1|90.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.4|70.1|< 0.001
71928218|NCT03000075|143378078|OTHER||Adjusted percentage difference|86.0|||<|0.001|TWO_SIDED|95.0|76.8|95.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||95.1|76.8|< 0.001
71928219|NCT03000075|143378080|OTHER||Adjusted percentage difference|22.6|||<|0.001|TWO_SIDED|95.0|11.8|33.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||33.4|11.8|< 0.001
71928220|NCT03000075|143378080|OTHER||Adjusted percentage difference|32.5|||<|0.001|TWO_SIDED|95.0|20.0|45.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||45.0|20.0|< 0.001
71928221|NCT03000075|143378082|OTHER||Adjusted percentage difference|39.2||||0.131|TWO_SIDED|95.0|-11.6|90.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.||90.1|-11.6|0.131
71928222|NCT03000075|143378082|OTHER|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs \> 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|31.3||||0.269|TWO_SIDED|95.0|-24.2|86.7||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|||86.7|-24.2|0.269
71928223|NCT00440193|143378084|NON_INFERIORITY_OR_EQUIVALENCE|Assuming equal efficacy, a total of 88 events was calculated to give a power of 90% to prove that rivaroxaban is at least as effective as the comparator, considering a non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided α=0.05). A mean incidence for the primary efficacy outcome of 3% was expected and at least 1465 participants per group were determined to be necessary. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|0.68|STANDARD_ERROR_OF_MEAN|0.2179|<|0.0001||95.0|0.44|1.04|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.||1.04|0.44|< 0.0001
71928224|NCT00440193|143378085|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|STANDARD_ERROR_OF_MEAN|0.1616||0.044||95.0|0.53|0.99||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.99|0.53|0.044
71928225|NCT00440193|143378086|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67|STANDARD_ERROR_OF_MEAN|0.1828||0.027||95.0|0.47|0.95||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||0.95|0.47|0.027
71928226|NCT00440193|143378088|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.97|STANDARD_ERROR_OF_MEAN|0.1204||0.77||95.0|0.76|1.22||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.|||1.22|0.76|0.77
71928227|NCT02222168|143378101|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|95.9|STANDARD_ERROR_OF_MEAN|50.7|||TWO_SIDED|90.0|72.593|126.682|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||126.682|72.593|
71928228|NCT02222168|143378101|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|82.13|STANDARD_ERROR_OF_MEAN|38.0|||TWO_SIDED|90.0|66.37|101.639|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||101.639|66.370|
71928229|NCT02222168|143378102|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.697|119.318|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.318|96.697|
71928230|NCT02222168|143378102|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.88|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.028|105.875|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.875|85.028|
71928231|NCT02222168|143378103|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 fed' was an Analysis of Variance (ANOVA ) model on the logarithmic scale.This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequences', 'period' and'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|Ratio (Fed/Fasted)|107.41|STANDARD_ERROR_OF_MEAN|18.2|||TWO_SIDED|90.0|96.709|119.301|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: fed (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||119.301|96.709|
71928232|NCT02222168|143378103|OTHER|The statistical model used for the analysis of the endpoint comparing 'BI 409306 fasted' against 'BI 409306 at bed-time' was an Analysis of Variance (ANOVA ) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subject' and 'treatment'. The effect 'subject' was considered as random, whereas the effect treatment was considered as fixed.|Ratio (Bed time/Fasted)|94.92|STANDARD_ERROR_OF_MEAN|19.1|||TWO_SIDED|90.0|85.061|105.921|||||The estimated parameter was the adjusted geometric mean ratios \[%\] of BI 409306: at bed time (numerator), fasted (denominator). The standard deviation is the intra-individual geometric coefficient of variation \[%\].|No formal hypothesis was tested.||105.921|85.061|
71928233|NCT00530621|143378104|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.13||||0.544||95.0|0.77|1.65||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.65|0.77|0.544
71689768|NCT05415462|142895892|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza A H3N2 strain at a 2-sided 0.025 level.|Percentage Difference|16.91|||||TWO_SIDED|97.5|14.27|19.54||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza A H3N2 Antibody||19.54|14.27|
71928234|NCT00530621|143378105|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.7||||0.171||95.0|0.42|1.17||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status and time since last chemotherapy.|Log Rank|||||1.17|0.42|0.171
71928235|NCT00530621|143378106|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.11||||0.01||95.0|1.19|3.75|||Regression, Cox|||||3.75|1.19|0.010
71928236|NCT00530621|143378107|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.5||||0.194||95.0|0.81|2.77||P-value was stratified by Eastern Cooperative Oncology Group (ECOG) performance status score and time since last chemotherapy.|Log Rank|||||2.77|0.81|0.194
71928237|NCT00530621|143378108|SUPERIORITY_OR_OTHER_LEGACY|||||||0.681|||||||Fisher Exact|||||||0.681
71928238|NCT03409328|143378114|OTHER||F|38.44|||<|0.001|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||<.001
71928239|NCT03409328|143378115|OTHER||F|6.69||||0.013|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.013
71928240|NCT03409328|143378116|OTHER||F|5.07||||0.029|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.029
71928241|NCT03409328|143378117|OTHER||F|0.38||||0.542|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||||||.542
71928242|NCT03409328|143378118|OTHER||F|3.12||||0.084|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is internalized stigma.||||.084
71689769|NCT05415462|142895892|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Victoria-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-17.34|||||TWO_SIDED|97.5|-20.22|-14.43||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Victoria Lineage||-14.43|-20.22|
71689770|NCT05415462|142895892|NON_INFERIORITY|The endpoint was tested for noninferiority of mRNA-1010 vs Fluarix for Influenza B Yamagata-lineage strain at a 2-sided 0.025 level.|Percentage Difference|-15.68|||||TWO_SIDED|97.5|-18.57|-12.76||||||Percentage Difference (mRNA-1010 vs Fluarix) for Influenza B/Yamagata Lineage||-12.76|-18.57|
71689771|NCT00502853|142895930|SUPERIORITY_OR_OTHER|||||||0.1776|||||||Student's t-test|||Change from Baseline to Week 4||||0.1776
71689772|NCT00502853|142895930|SUPERIORITY_OR_OTHER|||||||0.1215|||||||Student's t-test|||Change from Baseline to Week 24||||0.1215
71689773|NCT00502853|142895930|SUPERIORITY_OR_OTHER||Slope|-0.1606|STANDARD_ERROR_OF_MEAN|0.1231||0.2246|||||||Random coefficient model|||Trend over time||||0.2246
71928243|NCT03409328|143378118|OTHER||F|0.67||||0.417|TWO_SIDED||||||ANCOVA|The ANCOVA controlled for baseline levels of the outcome.||The outcome for this analysis is identity affirmation.||||.417
71928244|NCT00518011|143378121|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.842||||0.3644|TWO_SIDED|95.0|0.483|7.027|||Log Rank|||||7.027|0.483|0.3644
71928245|NCT00518011|143378125|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.278||||0.7165|TWO_SIDED|95.0|0.339|4.824|||Log Rank|||||4.824|0.339|0.7165
71928246|NCT03930615|143378139|SUPERIORITY||Treatment Difference|-16.1||||0.0005|TWO_SIDED|95.0|-25.8|-6.5||A one-sided p-value ≤0.0249 was used for declaring statistical significance|Mantel Haenszel|Stratum adjusted|Letermovir minus placebo|It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection.|95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-6.5|-25.8|0.0005
71928247|NCT03930615|143378140|OTHER||Difference in Percentage|-4.4|||||TWO_SIDED|95.0|-11.8|4.7|||||Letermovir minus Placebo||Miettinen \& Nurminen method|4.7|-11.8|
71928248|NCT03930615|143378141|OTHER||Difference in Percentage|3.5|||||TWO_SIDED|95.0|-2.7|8.6|||||Letermovir minus Placebo||Miettinen \& Nurminen method|8.6|-2.7|
71928249|NCT03930615|143378142|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
71928250|NCT03930615|143378143|SUPERIORITY||Treatment Difference|-5.7||||0.1591|TWO_SIDED|95.0|-16.8|5.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.4|-16.8|0.1591
71928251|NCT03930615|143378146|SUPERIORITY||Treatment difference|-14.1||||0.0012|TWO_SIDED|95.0|-23.3|-5.0|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|-5.0|-23.3|0.0012
71928252|NCT03930615|143378147|SUPERIORITY||Treatment Difference|-5.7||||0.1494|TWO_SIDED|95.0|-16.5|5.1|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.1|-16.5|0.1494
71928253|NCT03930615|143378148|SUPERIORITY||Treatment difference|0.7||||0.6244|TWO_SIDED|95.0|-3.8|5.3|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|5.3|-3.8|0.6244
71928254|NCT03930615|143378149|SUPERIORITY||Treatment Difference|0.3||||0.5264|TWO_SIDED|95.0|-7.9|8.4|||Mantel Haenszel|Stratum adjusted|Letermovir minus placebo||95% CIs for the treatment differences in percent response were calculated using stratum adjusted Mantel Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (haploidentical donor yes or no).|8.4|-7.9|0.5264
71928255|NCT01281475|143378152|SUPERIORITY|We modeled each outcome variable as a function of treatment (ie, levodopa versus placebo), visit (ie, baseline vs. 12-month follow-up) and the treatment-by-visit interaction; the interaction term tests whether the effect of levodopa treatment over time is significantly greater than that of the placebo group.||||||0.75||||||This was the calculated p value without correction for multiple comparisons|Generalized estimating equations|||We performed generalized estimating equations with an unstructured covariance matrix to account for inter-correlations within measurements on the same participant over time.||||0.75
71928256|NCT02080273|143378154|OTHER|||||||0.919|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.919
71928257|NCT02080273|143378155|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71928258|NCT02080273|143378156|SUPERIORITY_OR_OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71928259|NCT02080273|143378157|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71928260|NCT02080273|143378158|OTHER|||||||0.922|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.922
71928261|NCT02080273|143378159|OTHER|||||||0.848||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline||||0.848
71928262|NCT02080273|143378160|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71928263|NCT02080273|143378161|OTHER|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.||||0.001
71928264|NCT00903409|143378227|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The difference between Non-switchers and Switchers in the percent change in non-HDL-C level from the end of the OM6 double-blind study (average of Weeks 6 and 8 for the statistical analysis) to 4 months of OM6X open-label treatment (Month 4).|Kruskal-Wallis|||||||<0.001
71928265|NCT01516684|143378235|OTHER|||||||0.036|||||||T-test and chi-square|||Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.||||0.036
71928266|NCT01516684|143378237|OTHER|Marginal mixed model (GEE type)||||||0.094|||||||Mixed Models Analysis|||||||0.094
71928267|NCT01516684|143378238|OTHER|||||||0.382|||||||Chi-squared|||||||0.382
71928268|NCT01516684|143378239|OTHER|Marginal mixed model (GEE type)||||||0.426|||||||Mixed Models Analysis|||||||0.426
71928269|NCT02262507|143378291|OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.05
71928270|NCT00975000|143378311|SUPERIORITY_OR_OTHER||Chi-Square test statistic|66.437|||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and \> 11.2 mg/dL)||The primary endpoint was tested at a significance level of 0.05.||||<0.001
71689774|NCT00502853|142895931|SUPERIORITY_OR_OTHER|||||||0.8989|||||||Student's t-test|||Change from Baseline to Week 4||||0.8989
71928271|NCT00975000|143378311|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|91.41|||||TWO_SIDED|95.0|18.76|445.41|||||Odds ratio of Cinacalcet/Placebo|||445.41|18.76|
71928272|NCT00975000|143378311|SUPERIORITY_OR_OTHER||Difference|75.44|||||TWO_SIDED|95.0|63.83|87.05|||||Difference = Cinacalcet-Placebo|||87.05|63.83|
71928273|NCT00975000|143378312|SUPERIORITY_OR_OTHER||Difference|1.41||||0.266|TWO_SIDED|95.0|-1.1|3.93|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet - placebo)|||3.93|-1.10|0.266
71928274|NCT00975000|143378313|SUPERIORITY_OR_OTHER||Difference|0.45|||<|0.001|TWO_SIDED|95.0|0.26|0.64|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet - placebo)|||0.64|0.26|<0.001
71928275|NCT00975000|143378314|SUPERIORITY_OR_OTHER||Difference|-0.4||||0.842|TWO_SIDED|95.0|-4.37|3.57|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet - placebo)|||3.57|-4.37|0.842
71928276|NCT00975000|143378315|SUPERIORITY_OR_OTHER||Difference|-1.39|||<|0.001|TWO_SIDED|95.0|-1.62|-1.16|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet - placebo)|||-1.16|-1.62|<0.001
71928277|NCT00975000|143378316|SUPERIORITY_OR_OTHER||Difference|-117.21||||0.002|TWO_SIDED|95.0|-189.88|-44.55|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet - placebo)|||-44.55|-189.88|0.002
71928278|NCT00975000|143378317|SUPERIORITY_OR_OTHER||Difference|-1.42||||0.846|TWO_SIDED|95.0|-15.91|13.06|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet - placebo)|||13.06|-15.91|0.846
71928279|NCT00902486|143378322|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0619|TWO_SIDED|95.0|0.77|6.15|||Cochran-Armitage trend test||LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics|The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.||6.15|0.77|0.0619
71928280|NCT00902486|143378322|OTHER|||||||0.1978|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.||||0.1978
71928281|NCT00902486|143378322|OTHER|||||||0.0437|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.||||0.0437
71928282|NCT00902486|143378322|OTHER|||||||0.1236|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.||||0.1236
71928283|NCT02411110|143378377|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.34||||0.505|||||||ANCOVA|Baseline value as a covariate; treatment group and stratification (age: \< 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or \> 6) as factors.|LiRIS® - Placebo|||||0.505
71928284|NCT02871921|143378389|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.86||0.87|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among participants with normal cognition||||0.87
71689775|NCT00502853|142895931|SUPERIORITY_OR_OTHER|||||||0.8834|||||||Student's t-test|||Change from Baseline to Week 24||||0.8834
71928285|NCT02871921|143378389|EQUIVALENCE|A linear regression model was run with the outcome being the MoCA score at Month 6, controlling for the baseline MoCA score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score.|Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.76||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: MoCA at Month 6 Among MCI||||.03
71928286|NCT02871921|143378390|EQUIVALENCE|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|2.56|STANDARD_ERROR_OF_MEAN|1.19||0.03|TWO_SIDED||||||Regression, Linear|||Outcome: Category fluency animals Among participants with normal cognition||||0.03
71928287|NCT02871921|143378390|OTHER|A linear regression model was run with the outcome being the Category Fluency test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|0.69|STANDARD_ERROR_OF_MEAN|0.93||0.46|TWO_SIDED||||||Regression, Linear|||Outcome: Category Fluency (Animals) at Month 6 Among MCI participants||||0.46
71928288|NCT02871921|143378391|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Stroy Immediate Recall score at Month 6, controlling for its baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.82||0.45|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Stroy Immediate Recall (paraphrase scoring) Among participants with normal cognition||||0.45
71928289|NCT02871921|143378391|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.8||0.41|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Immediate Recall (paraphrase) Among MCI||||0.41
71928290|NCT02871921|143378392|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.77||0.74|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall) (Paraphrase scoring) Among participants with normal cognition||||0.74
71928291|NCT02871921|143378392|EQUIVALENCE|A linear regression model was run with the outcome being the Craft Story test score at Month 6, controlling for tits baseline score. The coefficient of the treatment indicator (1: experimental group, 0: control group) is our main interest. The significant coefficient means that treatment and control groups differ in the outcome score at Month 6, controlling for the baseline score and a COVID-19 pandemic period indicator (0: pre-COVID-19 pandemic, 1: during COVID-19 pandemic period).|Median Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.79||0.9|TWO_SIDED||||||Regression, Linear|||Outcome: Craft Story Delayed Recall (Paraphrase scoring) Among MCI||||0.90
71928292|NCT01803464|143378399|OTHER||Cohen's d|0.59|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled Standard Deviation (SD) of the % change for the 2 groups was the denominator.|||||
71928293|NCT01803464|143378399|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71928294|NCT01803464|143378399|OTHER||Cohen's d|0.51|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71928295|NCT01803464|143378400|OTHER||Cohen's d|0.45|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
71928296|NCT01803464|143378400|OTHER||Cohen's d|0.57|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71928297|NCT01803464|143378400|OTHER||Cohen's d|0.13|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator|||||
71928298|NCT01803464|143378401|OTHER||Cohen's d|1.2|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71928299|NCT01803464|143378401|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71928300|NCT01803464|143378401|OTHER||Cohen's d|0.33|||||TWO_SIDED||||||||Cohen's d was calculated. The % change of the typically developing control group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.|||||
71928301|NCT02424851|143378402|OTHER|||||||0.006|||||||Fisher Exact|||||||0.006
71928302|NCT02424851|143378403|OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71928303|NCT02424851|143378404|OTHER||||||=|0.48|||||||Fisher Exact|||Statistical analysis of SAEs.||||=0.48
71928304|NCT02424851|143378404|OTHER||||||=|0.25|||||||Fisher Exact|||Statistical analysis of AEs||||=0.25
71928305|NCT02424851|143378405|OTHER||||||=|0.31|||||||Log Rank|||||||= 0.31
71689776|NCT00502853|142895931|SUPERIORITY_OR_OTHER||Slope|0.1357|STANDARD_ERROR_OF_MEAN|0.9051||0.8841|||||||Random coefficient model|||Trend over time||||0.8841
71928306|NCT02424851|143378406|OTHER||||||=|0.45|||||||Fisher Exact|||||||=0.45
71928307|NCT02424851|143378407|OTHER|||||||0.33|||||||t-test, 1 sided|||||||0.33
71928308|NCT01360021|143378416|SUPERIORITY_OR_OTHER||Estimated Geometic Mean Ratio|1.1||||0.001|TWO_SIDED|95.0|1.06|1.14|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid|The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1||1.14|1.06|0.001
71928309|NCT01360021|143378416|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.01|||||TWO_SIDED|95.0|0.97|1.05|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.||1.05|0.97|
71928310|NCT01360021|143378417|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.03|||||TWO_SIDED|95.0|0.99|1.08|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.||1.08|0.99|
71928311|NCT01360021|143378418|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.49|STANDARD_ERROR_OF_MEAN|6.75||0.825|TWO_SIDED|95.0|-11.81|14.8|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid||14.80|-11.81|0.825
71928312|NCT01360021|143378418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|33.52|STANDARD_ERROR_OF_MEAN|6.8||0.001|TWO_SIDED|95.0|20.11|46.93|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid||46.93|20.11|0.001
71928313|NCT01360021|143378418|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.48|STANDARD_ERROR_OF_MEAN|6.15||0.81|TWO_SIDED|95.0|-10.66|13.61|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||13.61|-10.66|0.810
71928314|NCT01360021|143378418|SUPERIORITY_OR_OTHER||Mean Difference (Net)|32.25|STANDARD_ERROR_OF_MEAN|6.21||0.001|TWO_SIDED|95.0|20.01|44.49|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.||44.49|20.01|0.001
71928315|NCT01360021|143378419|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.272|TWO_SIDED|95.0|-0.1|0.35|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||0.35|-0.10|0.272
71928316|NCT01360021|143378420|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|-6.1|STANDARD_ERROR_OF_MEAN|2.69||0.025|TWO_SIDED|95.0|-11.41|-0.79|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.||-0.79|-11.41|0.025
71928317|NCT01360021|143378421|NON_INFERIORITY_OR_EQUIVALENCE|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.26|STANDARD_ERROR_OF_MEAN|0.23||0.258|TWO_SIDED|95.0|-0.19|0.71|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.||0.71|-0.19|0.258
71928318|NCT02446496|143378422|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|95.91|||||TWO_SIDED|90.0|85.67|107.37||||||||107.37|85.67|
71928319|NCT02446496|143378423|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|102.31|||||TWO_SIDED|90.0|90.46|115.7|||||Comparison of AUC (0-t) between Treatment A and Treatment B|||115.70|90.46|
71928320|NCT02446496|143378423|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|103.13|||||TWO_SIDED|90.0|91.19|116.62|||||Comparison of AUC(0-infinity) between Treatment A and Treatment B|||116.62|91.19|
71928321|NCT02446496|143378424|SUPERIORITY_OR_OTHER|||||||0.267||95.0|||||Wilcoxon's Signed-Rank Test|Comparison of T-max between Treatment A and Treatment B.||||||0.2670
71928322|NCT03170271|143378440|SUPERIORITY|The null hypothesis was that the exacerbation rate of benralizumab was equal to the exacerbation rate of placebo.|Rate ratio|0.51|||<|0.0001|TWO_SIDED|95.0|0.39|0.65|||Negative binomial|||Comparison of annual exacerbation rates for benralizumab vs placebo (rate ratio). Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the negative binomial model as covariates. The log of each patient's corresponding follow-up time was used as an offset variable in the model to adjust for patients having different follow-up times during which events occurred.||0.65|0.39|<0.0001
71928323|NCT03170271|143378441|SUPERIORITY||LS Mean difference|-8.11|||<|0.0001|TWO_SIDED|95.0|-11.41|-4.82|||Repeated measures analysis||Model: Change from baseline in SGRQ total score = Treatment + baseline SGRQ total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SGRQ total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a mixed-effect model for repeated measures (MMRM) analysis.||-4.82|-11.41|<0.0001
71928324|NCT03170271|143378442|SUPERIORITY||LS Mean difference|0.16|||<|0.0001|TWO_SIDED|95.0|0.09|0.23|||Repeated measures analysis||Model: Change from baseline in pre-BD FEV1 = Treatment + baseline pre-BD FEV1 + region + number of exacerbations in previous year + maintenance OCS use at baseline + gender + age + visit + treatment by visit.|Change from baseline in pre-BD FEV1 at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||0.23|0.09|<0.0001
71928325|NCT03170271|143378443|SUPERIORITY||LS Mean difference|-0.46|||<|0.0001|TWO_SIDED|95.0|-0.65|-0.27|||Repeated measures analysis||Model: Change from baseline in ACQ-6 score = Treatment + baseline ACQ-6 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in ACQ-6 score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.27|-0.65|<0.0001
71928326|NCT03170271|143378444|SUPERIORITY||Hazard Ratio (HR)|0.52|||<|0.0001|TWO_SIDED|95.0|0.4|0.67|||Regression, Cox||A hazard ratio \< 1 favours benralizumab to be associated with a longer time from randomization to the first exacerbation than placebo.|Comparison of time to first asthma exacerbation for benralizumab vs placebo. Treatment group, region, number of exacerbations in previous year and maintenance OCS use at baseline were included in the Cox proportional hazard model as covariates.||0.67|0.40|<0.0001
71928327|NCT03170271|143378445|SUPERIORITY||LS Mean difference|20.11||||0.0031|TWO_SIDED|95.0|6.79|33.44|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in morning PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||33.44|6.79|0.0031
71928328|NCT03170271|143378445|SUPERIORITY||LS Mean Difference|23.09||||0.0008|TWO_SIDED|95.0|9.62|36.55|||Repeated measures analysis||Model: Change from baseline in PEF = Treatment + baseline PEF + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from run-in baseline in evening PEF at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||36.55|9.62|0.0008
71928329|NCT03170271|143378446|SUPERIORITY||LS Mean difference|5.35||||0.0077|TWO_SIDED|95.0|1.42|9.28|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for physical functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.28|1.42|0.0077
71928330|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|6.8||||0.0022|TWO_SIDED|95.0|2.45|11.14|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to physical health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||11.14|2.45|0.0022
71928331|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|3.07||||0.1741|TWO_SIDED|95.0|-1.36|7.5|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for bodily pain at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.50|-1.36|0.1741
71928332|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|5.62||||0.0009|TWO_SIDED|95.0|2.32|8.92|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for general health perceptions at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||8.92|2.32|0.0009
71928333|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|5.51||||0.0025|TWO_SIDED|95.0|1.95|9.08|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for vitality at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||9.08|1.95|0.0025
71928334|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|3.12||||0.1583|TWO_SIDED|95.0|-1.22|7.46|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for social functioning at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||7.46|-1.22|0.1583
71928335|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|2.44||||0.2103|TWO_SIDED|95.0|-1.38|6.27|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for role limitations due to emotional problems at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||6.27|-1.38|0.2103
71928336|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|1.68||||0.2581|TWO_SIDED|95.0|-1.23|4.59|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 subscale score for mental health at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||4.59|-1.23|0.2581
71928337|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|2.32||||0.0022|TWO_SIDED|95.0|0.84|3.81|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 physical health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||3.81|0.84|0.0022
71928338|NCT03170271|143378446|SUPERIORITY||LS Mean Difference|0.87||||0.2751|TWO_SIDED|95.0|-0.7|2.44|||Repeated measures analysis||Model: Change from baseline in SF-36v2 score = Treatment + baseline SF-36v2 score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SF-36v2 mental health component summary score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||2.44|-0.70|0.2751
71928339|NCT03170271|143378447|SUPERIORITY||Odds Ratio (OR)|1.55||||0.0233|TWO_SIDED|95.0|1.06|2.25|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.25|1.06|0.0233
71928340|NCT03170271|143378447|SUPERIORITY||Odds Ratio (OR)|1.48||||0.0401|TWO_SIDED|95.0|1.02|2.16|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + baseline score + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a responder classified as type 'Important Improvement' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.16|1.02|0.0401
71928341|NCT03170271|143378448|SUPERIORITY||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.47|2.86|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.86|1.47|<0.0001
71928342|NCT03170271|143378448|SUPERIORITY||Odds Ratio (OR)|3.45||||0.0003|TWO_SIDED|95.0|1.77|6.7|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a CGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||6.70|1.77|0.0003
71928343|NCT03170271|143378448|SUPERIORITY||Odds Ratio (OR)|2.06|||<|0.0001|TWO_SIDED|95.0|1.48|2.87|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||2.87|1.48|<0.0001
71928344|NCT03170271|143378448|SUPERIORITY||Odds Ratio (OR)|3.02|||<|0.0001|TWO_SIDED|95.0|2.02|4.51|||Regression, Logistic||Model: ln (1/(1-p)) = Treatment + region + number of exacerbations in previous year + maintenance OCS use at baseline, where p is the proportion of patients being a responder.|Estimate of the log odds of being a PGI-C responder classified as type 'Very much improved' at Week 24 in the benralizumab group compared to the placebo group using a logistic regression.||4.51|2.02|<0.0001
71928345|NCT03170271|143378449|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.62|-0.68|||Repeated measures analysis||Model: Change from baseline in average PSIA score (top 3 ranked) =Treatment + baseline average PSIA score (top 3 ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score for the average of top 3 ranked symptoms/impairments at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.68|-1.62|<0.0001
71928346|NCT03170271|143378449|SUPERIORITY||LS Mean difference|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.64|-0.66|||Repeated measures analysis||Model: Change from baseline in PSIA score (top ranked) =Treatment + baseline PSIA score (top ranked) + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in PSIA severity score of top ranked symptom/impairment at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-0.66|-1.64|<0.0001
71928347|NCT03170271|143378450|SUPERIORITY||LS Mean difference|-8.91||||0.0204|TWO_SIDED|95.0|-16.42|-1.4|||Repeated measures analysis||Model: Change from baseline in SNOT-22 total score = Treatment + baseline SNOT-22 total score + region + number of exacerbations in previous year + maintenance OCS use at baseline + visit + treatment by visit.|Change from baseline in SNOT-22 total score at Week 24 was compared between the benralizumab group and placebo group using a restricted maximum likelihood based on a MMRM analysis.||-1.40|-16.42|0.0204
71928348|NCT01244516|143378476|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.83|||TWO_SIDED|97.4|-5.91|6.7|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - AOA.|This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B \<= -5. Ha: galyfilcon A - lotrafilcon B \> -5.||6.70|-5.91|
71928349|NCT01244516|143378476|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|2.79|||TWO_SIDED|97.4|-5.96|6.79|||Mixed Models Analysis|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP - BIO.|This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A \<= -5. Ha: galyfilcon A- comfilcon A\> -5.||6.79|-5.96|
71928350|NCT01244516|143378477|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.|The direction of comparison is AAHP/AOA.|The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR \> 1 for (AAHP/AOA).||2.44|1.14|
71928351|NCT01244516|143378477|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is set at \> 0.75. Superiority is concluded is the 97.4% CL \> 1.|Odds Ratio (OR)|1.66|||||TWO_SIDED|97.4|1.14|2.44|||Regression, Logistic|Alpha is adjusted to 1.3% based on a Sidak multiplicity correction.||The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR \> 1 for (AAHP/BIO).||2.44|1.14|
71928352|NCT01984229|143378518|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|118.0|||||TWO_SIDED|90.0|102.0|137.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals (CIs).||137|102|
71928353|NCT01984229|143378519|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|177.0|||||TWO_SIDED|90.0|159.0|198.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||198|159|
71928354|NCT01984229|143378520|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|175.0|||||TWO_SIDED|90.0|157.0|195.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||195|157|
71928355|NCT01984229|143378524|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|28.7|||||TWO_SIDED|90.0|23.1|35.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||35.5|23.1|
71928356|NCT01984229|143378525|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|66.2|||||TWO_SIDED|90.0|56.7|77.4|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||77.4|56.7|
71928357|NCT01984229|143378526|SUPERIORITY_OR_OTHER||Geometric Least Square Mean Ratio|75.1|||||TWO_SIDED|90.0|64.4|87.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.||87.7|64.4|
71928358|NCT02325739|143378537|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fasted) is 120mg.|||||
71928359|NCT02325739|143378537|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 (single agent - fed) is 120mg.|||||
71928360|NCT02325739|143378537|OTHER||RP2D|120.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for FGF401 120mg.|||||
71928361|NCT02325739|143378537|OTHER||RP2D|300.0|||||||||||||The estimation parameter and recommended Phase 2 dose level for FGF401 + PDR001 combination is for PDR001 300mg.|||||
71928362|NCT03226366|143378556|SUPERIORITY||Mean Difference (Final Values)|-7.9||||0.29|TWO_SIDED|95.0|-20.4|6.1|||Regression, Linear||Change in emergency department door-to-antibiotic time (minutes) based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-antibiotic time after versus before intervention implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||6.1|-20.4|0.29
71928363|NCT03226366|143378557|SUPERIORITY||Odds Ratio (OR)|0.81||||0.72|TWO_SIDED|95.0|0.25|2.61|||Regression, Logistic||Odds ratio for hospital mortality after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||2.61|0.25|0.72
71928364|NCT03226366|143378558|SUPERIORITY||Mean Difference (Final Values)|-9.5||||0.26|TWO_SIDED|95.0|-25.9|7.0|||Regression, Linear||Change in emergency department length of stay (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.||7.0|-25.9|0.26
71928365|NCT03226366|143378559|SUPERIORITY||Mean Difference (Final Values)|-0.8||||0.55|TWO_SIDED|95.0|-3.3|1.8|||Regression, Linear||Estimated change in emergency department door-to-physician evaluation time (minutes) after versus before intervention implementation based on adjusted differences-in-differences analysis|Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.||1.8|-3.3|0.55
71689777|NCT00502853|142895932|SUPERIORITY_OR_OTHER|||||||0.5911|||||||Student's t-test|||Change from Baseline to Week 4||||0.5911
71928366|NCT02596009|143378564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.97|||<|0.0001|TWO_SIDED|95.0|23.7|30.24|||paired t-test|||||30.24|23.70|<0.0001
71928367|NCT02596009|143378564|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.93|||<|0.0001|TWO_SIDED|95.0|49.15|58.72|||paired t-test|||||58.72|49.15|<0.0001
71928368|NCT04611152|143378609|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|0.84||0.4162|TWO_SIDED|95.04|-5.47|-2.17|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.17|-5.47|0.4162
71928369|NCT04611152|143378610|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
71928370|NCT04611152|143378611|NON_INFERIORITY|"The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%"|Difference of weighted percentages|0.0|||||TWO_SIDED|95.04|0.0|0.0|||||Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||0|0|
71928371|NCT00956813|143378627|SUPERIORITY_OR_OTHER|||||||0.29|||||||t-test, 2 sided|||||||0.29
71928372|NCT00956813|143378629|SUPERIORITY_OR_OTHER|||||||0.93|||||||Kruskal-Wallis|||||||0.93
71928373|NCT00956813|143378630|SUPERIORITY_OR_OTHER|||||||0.19|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.||||0.19
71928374|NCT00956813|143378630|SUPERIORITY_OR_OTHER|||||||0.78|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.||||0.78
71928375|NCT00956813|143378630|SUPERIORITY_OR_OTHER|||||||0.238|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.||||0.238
71928376|NCT00956813|143378630|SUPERIORITY_OR_OTHER|||||||0.497|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.||||0.497
71928377|NCT00956813|143378631|SUPERIORITY_OR_OTHER|||||||0.089|||||||Kruskal-Wallis|||||||0.089
71928378|NCT01275170|143378647|OTHER|Geometric mean ratio (GMR) \[Renal Impairment/Healthy Control\]|GMR|1.63|||||TWO_SIDED|90.0|1.12|2.39||||||||2.39|1.12|
71928379|NCT01275170|143378647|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.19|||||TWO_SIDED|90.0|1.51|3.18||||||||3.18|1.51|
71928380|NCT01275170|143378647|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|4.87|||||TWO_SIDED|90.0|3.37|7.04||||||||7.04|3.37|
71928381|NCT01275170|143378647|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|9.32|||||TWO_SIDED|90.0|6.45|13.46||||||||13.46|6.45|
71928382|NCT01275170|143378647|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.76|||||TWO_SIDED|90.0|1.2|2.58||||||||2.58|1.20|
71928383|NCT01275170|143378648|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.1|||||TWO_SIDED|90.0|0.64|1.88||||||||1.88|0.64|
71928384|NCT01275170|143378648|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.04|||||TWO_SIDED|90.0|0.62|1.77||||||||1.77|0.62|
71928385|NCT01275170|143378648|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.3|||||TWO_SIDED|90.0|0.77|2.2||||||||2.20|0.77|
71928386|NCT01275170|143378648|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.34|||||TWO_SIDED|90.0|1.39|3.96||||||||3.96|1.39|
71928387|NCT01275170|143378648|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.85|||||TWO_SIDED|90.0|0.5|1.44||||||||1.44|0.50|
71689778|NCT00502853|142895932|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Student's t-test|||Change from Baseline to Week 24||||0.1475
71928388|NCT01275170|143378649|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.42|0.9||||||||0.90|0.42|
71928389|NCT01275170|143378649|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.46|||||TWO_SIDED|90.0|0.31|0.66||||||||0.66|0.31|
71928390|NCT01275170|143378649|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.21|||||TWO_SIDED|90.0|0.14|0.3||||||||0.30|0.14|
71928391|NCT01275170|143378649|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.11|||||TWO_SIDED|90.0|0.07|0.16||||||||0.16|0.07|
71928392|NCT01275170|143378649|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.57|||||TWO_SIDED|90.0|0.39|0.84||||||||0.84|0.39|
71928393|NCT01275170|143378650|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.82|1.21||||||||1.21|0.82|
71928394|NCT01275170|143378650|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.84|1.22||||||||1.22|0.84|
71928395|NCT01275170|143378650|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.9|||||TWO_SIDED|90.0|0.74|1.08||||||||1.08|0.74|
71928396|NCT01275170|143378650|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.96|||||TWO_SIDED|90.0|0.79|1.16||||||||1.16|0.79|
71928397|NCT01275170|143378650|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.28|||||TWO_SIDED|90.0|2.7|4.0||||||||4.00|2.70|
71928398|NCT01275170|143378653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.41|||||TWO_SIDED|90.0|1.07|1.84||||||||1.84|1.07|
71928399|NCT01275170|143378653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.53|||||TWO_SIDED|90.0|1.17|1.99||||||||1.99|1.17|
71928400|NCT01275170|143378653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.51|||||TWO_SIDED|90.0|1.93|3.26||||||||3.26|1.93|
71928401|NCT01275170|143378653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.1|||||TWO_SIDED|90.0|2.39|4.03||||||||4.03|2.39|
71928402|NCT01275170|143378653|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||TWO_SIDED|90.0|0.76|1.29||||||||1.29|0.76|
71928403|NCT01275170|143378654|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.15|||||TWO_SIDED|90.0|0.65|2.06||||||||2.06|0.65|
71928404|NCT01275170|143378654|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.61|1.89||||||||1.89|0.61|
71928405|NCT01275170|143378654|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.32|||||TWO_SIDED|90.0|0.75|2.32||||||||2.32|0.75|
71928406|NCT01275170|143378654|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.46|||||TWO_SIDED|90.0|1.4|4.33||||||||4.33|1.40|
71928407|NCT01275170|143378654|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.86|||||TWO_SIDED|90.0|0.49|1.51||||||||1.51|0.49|
71928408|NCT01275170|143378655|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.71|||||TWO_SIDED|90.0|0.54|0.93||||||||0.93|0.54|
71928409|NCT01275170|143378655|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.65|||||TWO_SIDED|90.0|0.5|0.85||||||||0.85|0.50|
71928410|NCT01275170|143378655|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.4|||||TWO_SIDED|90.0|0.31|0.52||||||||0.52|0.31|
71928411|NCT01275170|143378655|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.32|||||TWO_SIDED|90.0|0.25|0.42||||||||0.42|0.25|
71928412|NCT01275170|143378655|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||TWO_SIDED|90.0|0.78|1.31||||||||1.31|0.78|
71928413|NCT01275170|143378656|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.61|1.08||||||||1.08|0.61|
71928414|NCT01275170|143378656|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.95|||||TWO_SIDED|90.0|0.72|1.26||||||||1.26|0.72|
71928415|NCT01275170|143378656|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.61|1.06||||||||1.06|0.61|
71928416|NCT01275170|143378656|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.83|||||TWO_SIDED|90.0|0.63|1.09||||||||1.09|0.63|
71928417|NCT01275170|143378656|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.54|||||TWO_SIDED|90.0|1.93|3.36||||||||3.36|1.93|
71689779|NCT00502853|142895932|SUPERIORITY_OR_OTHER||Slope|0.1786|STANDARD_ERROR_OF_MEAN|0.1123||0.1463|||||||Random coefficient model|||Trend over time||||0.1463
71928418|NCT01275170|143378659|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.6|||||TWO_SIDED|90.0|1.03|2.49||||||||2.49|1.03|
71928419|NCT01275170|143378659|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.86|||||TWO_SIDED|90.0|1.21|2.87||||||||2.87|1.21|
71928420|NCT01275170|143378659|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|5.6|||||TWO_SIDED|90.0|3.64|8.59||||||||8.59|3.64|
71928421|NCT01275170|143378659|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|13.75|||||TWO_SIDED|90.0|8.96|21.12||||||||21.12|8.96|
71928422|NCT01275170|143378659|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|3.64|||||TWO_SIDED|90.0|2.32|5.69||||||||5.69|2.32|
71928423|NCT01275170|143378660|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.25|||||TWO_SIDED|90.0|0.75|2.08||||||||2.08|0.75|
71928424|NCT01275170|143378660|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.13|||||TWO_SIDED|90.0|0.69|1.87||||||||1.87|0.69|
71928425|NCT01275170|143378660|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.49|||||TWO_SIDED|90.0|0.9|2.44||||||||2.44|0.90|
71928426|NCT01275170|143378660|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.49|||||TWO_SIDED|90.0|1.51|4.09||||||||4.09|1.51|
71928427|NCT01275170|143378660|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.94|||||TWO_SIDED|90.0|0.57|1.54||||||||1.54|0.57|
71928428|NCT01275170|143378661|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.4|0.97||||||||0.97|0.40|
71928429|NCT01275170|143378661|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.54|||||TWO_SIDED|90.0|0.35|0.83||||||||0.83|0.35|
71928430|NCT01275170|143378661|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.18|||||TWO_SIDED|90.0|0.12|0.27||||||||0.27|0.12|
71928431|NCT01275170|143378661|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.07|||||TWO_SIDED|90.0|0.05|0.11||||||||0.11|0.05|
71928432|NCT01275170|143378661|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.27|||||TWO_SIDED|90.0|0.18|0.43||||||||0.43|0.18|
71928433|NCT01275170|143378662|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.04||||||||1.04|0.62|
71928434|NCT01275170|143378662|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.71|1.17||||||||1.17|0.71|
71928435|NCT01275170|143378662|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||TWO_SIDED|90.0|0.62|1.03||||||||1.03|0.62|
71928436|NCT01275170|143378662|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.76|||||TWO_SIDED|90.0|0.59|0.97||||||||0.97|0.59|
71928437|NCT01275170|143378662|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|2.81|||||TWO_SIDED|90.0|2.16|3.65||||||||3.65|2.16|
71689780|NCT00502853|142895933|SUPERIORITY_OR_OTHER|||||||0.1101|||||||Student's t-test|||Change from Baseline at Week 4||||0.1101
71928438|NCT01275170|143378668|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.52|||||TWO_SIDED|90.0|1.07|2.15||||||||2.15|1.07|
71928439|NCT01275170|143378668|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||TWO_SIDED|90.0|0.45|0.9||||||||0.90|0.45|
71928440|NCT01275170|143378668|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.67|||||TWO_SIDED|90.0|0.47|0.94||||||||0.94|0.47|
71928441|NCT01275170|143378669|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||TWO_SIDED|90.0|0.63|1.83||||||||1.83|0.63|
71928442|NCT01275170|143378669|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.6|||||TWO_SIDED|90.0|0.35|1.01||||||||1.01|0.35|
71928443|NCT01275170|143378669|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||TWO_SIDED|90.0|0.36|1.04||||||||1.04|0.36|
71928444|NCT01275170|143378670|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|1.47|||||TWO_SIDED|90.0|0.63|3.4||||||||3.40|0.63|
71928445|NCT01275170|143378670|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||TWO_SIDED|90.0|0.41|2.0||||||||2.00|0.41|
71928446|NCT01275170|143378670|OTHER|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||TWO_SIDED|90.0|0.37|1.78||||||||1.78|0.37|
71928447|NCT03252015|143378751|SUPERIORITY||Mean Difference (Final Values)|-0.182|||||TWO_SIDED|95.0|-0.412|0.049||||||Day 7||0.049|-0.412|
71928448|NCT03252015|143378751|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||Day 7||0.224|-0.081|
71928449|NCT03252015|143378751|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
71928450|NCT03252015|143378751|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
71928451|NCT03252015|143378752|SUPERIORITY||Mean Difference (Final Values)|-0.145|||||TWO_SIDED|95.0|-0.34|0.05||||||Day 7||0.050|-0.340|
71928452|NCT03252015|143378752|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.081|0.224||||||||0.224|-0.081|
71928453|NCT03252015|143378752|SUPERIORITY||Mean Difference (Final Values)|0.071|||||TWO_SIDED|95.0|-0.151|0.294||||||Day 21||0.294|-0.151|
71928454|NCT03252015|143378752|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|0.0|0.0||||||Day 21||0.000|0.000|
71928455|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.656|STANDARD_ERROR_OF_MEAN|1.85|||TWO_SIDED|95.0|-0.032|7.344|||||Hydromorphone - Placebo|"Week 1~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||7.344|-0.032|
71928456|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.927|STANDARD_ERROR_OF_MEAN|1.848|||TWO_SIDED|95.0|3.243|10.612|||||Hydromorphone - Placebo|Week 1 Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05.||10.612|3.243|
71928457|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.586|STANDARD_ERROR_OF_MEAN|1.283|||TWO_SIDED|95.0|-1.977|3.149|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||3.149|-1.977|
71928458|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|2.899|STANDARD_ERROR_OF_MEAN|1.285|||TWO_SIDED|95.0|0.333|5.465|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||5.465|0.333|
71928459|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|0.863|STANDARD_ERROR_OF_MEAN|1.959|||TWO_SIDED|95.0|-3.053|4.778|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||4.778|-3.053|
71928460|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|4.926|STANDARD_ERROR_OF_MEAN|1.956|||TWO_SIDED|95.0|1.016|8.837|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.837|1.016|
71928461|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|3.316|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|-1.425|8.025|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||8.025|-1.425|
71928462|NCT02044094|143378864|NON_INFERIORITY|Blockade was achieved if the upper bound of the 95% confidence interval was \<= the non-inferiority margin of 11.|LSM difference|6.677|STANDARD_ERROR_OF_MEAN|2.367|||TWO_SIDED|95.0|1.936|11.418|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."||11.418|1.936|
71928463|NCT03353415|143378890|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71928464|NCT03353415|143378891|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71928465|NCT03353415|143378892|OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71928466|NCT03353415|143378893|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||||||0.45
71928467|NCT03353415|143378894|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71928468|NCT03353415|143378895|OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71928469|NCT03353415|143378896|OTHER|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71928470|NCT03353415|143378897|OTHER|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||||||0.65
71928471|NCT03353415|143378898|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71928472|NCT03353415|143378899|OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71928473|NCT03353415|143378900|OTHER|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71928474|NCT03353415|143378901|OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||||||0.09
71928475|NCT03353415|143378902|OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71928476|NCT03353415|143378903|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71928477|NCT03353415|143378904|OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||||||0.15
71928478|NCT03353415|143378905|OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||||||0.03
71928479|NCT03353415|143378906|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71928480|NCT03353415|143378907|OTHER|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||||||0.32
71928481|NCT03353415|143378908|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||||||0.41
71928482|NCT03353415|143378909|OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71928483|NCT03353415|143378910|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71928484|NCT01017731|143378936|SUPERIORITY_OR_OTHER|||||||0.0161||||||The p-value for QTc interval prolongation compared to baseline.|Mixed Models Analysis|||||||0.0161
71928485|NCT03926728|143378966|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
71928486|NCT03926728|143378966|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
71928487|NCT03926728|143378966|OTHER|||||||0.0007|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.0007
71928488|NCT03926728|143378969|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
71928489|NCT03926728|143378969|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
71928490|NCT03926728|143378970|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs A2.||||1
71928491|NCT03926728|143378970|OTHER|||||||0.3956|||||||Fisher Exact|||Comparison: Cohort B \[B1, B2\] vs F1.||||0.3956
71928492|NCT03926728|143378972|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].||||1
71928493|NCT03926728|143378972|OTHER|||||||1||||||Simple nonparametric statistical test.|Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].||||1
71928494|NCT03926728|143378972|OTHER|||||||0.3229|||||||Fisher Exact|||Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].||||0.3229
71928495|NCT01107834|143378977|SUPERIORITY_OR_OTHER|||||||0.27|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.27
71928496|NCT01107834|143378978|SUPERIORITY_OR_OTHER|||||||0.46|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.46
71928497|NCT01107834|143378979|SUPERIORITY_OR_OTHER|||||||0.13|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.13
71928498|NCT01107834|143378980|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.59
71928499|NCT01107834|143378981|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.09
71928500|NCT01107834|143378982|SUPERIORITY_OR_OTHER|||||||0.03|||||||t-test, 2 sided|||T-test to detect differences between groups||||0.03
71928501|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9257|||||TWO_SIDED|95.0|0.844|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.844|
71928502|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9321|||||TWO_SIDED|95.0|0.858|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.858|
71928503|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
71928504|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8699|||||TWO_SIDED|95.0|0.79|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.949|0.790|
71928505|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9607|||||TWO_SIDED|95.0|0.927|0.995||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||0.995|0.927|
71928506|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9948|||||TWO_SIDED|95.0|0.985|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.985|
71928507|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
71928508|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.0000|1.0000|
71928509|NCT02118896|143379008|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.||1.000|0.933|
71928510|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8391|||||TWO_SIDED|95.0|0.729|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.949|0.729|
71928511|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8792|||||TWO_SIDED|95.0|0.778|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula..||0.981|0.778|
71928512|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8816|||||TWO_SIDED|95.0|0.782|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.782|
71928513|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.7769|||||TWO_SIDED|95.0|0.675|0.878||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.878|0.675|
71928514|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.8373|||||TWO_SIDED|95.0|0.693|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||0.981|0.693|
71928515|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9419|||||TWO_SIDED|95.0|0.883|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.883|
71928516|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|1.000|
71928517|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9898|||||TWO_SIDED|95.0|0.97|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.970|
71928518|NCT02118896|143379011|SUPERIORITY_OR_OTHER_LEGACY||Kaplan-Meier Method|0.9773|||||TWO_SIDED|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.||1.000|0.933|
71928519|NCT03292731|143379012|OTHER||Odds Ratio (OR)|1.0||||0.96|TWO_SIDED|95.0|0.93|1.08||adjusted for cerclage|Regression, Logistic|adjusted for cerclage||logistic regression comparing drug concentration to the rate of sPTB||1.08|0.93|0.96
71928520|NCT03292731|143379013|OTHER||Slope|1.11||||0.05|TWO_SIDED|95.0|0.0|2.23|||Regression, Linear|||||2.23|0.00|0.05
71928521|NCT03292731|143379014|OTHER||Slope|1.56||||0.022|TWO_SIDED|95.0|0.25|2.87|||Regression, Linear|||||2.87|0.25|0.022
71928522|NCT03292731|143379015|SUPERIORITY|||||||0.82||||||no adjustments|Fisher Exact|||Only RCT subjects utilized in neonatal safety analysis||||0.82
71928523|NCT03901352|143379019|SUPERIORITY||Difference of LSM vs placebo|-0.71|STANDARD_ERROR_OF_MEAN|0.187||0.0001|TWO_SIDED|95.0|-1.08|-0.34|||ANCOVA||"The multiple imputation (MI) was based on a nonfuture dependence model using the pattern mixture model (PMM) approach with shifting parameters under the missing not at random (MNAR0 mechanism for the missing weekly ADPS."|||-0.34|-1.08|0.0001
71928524|NCT02050373|143379031|OTHER|For the comparison between the LLLT and control groups the Pearson chi-square (χ2) or Fisher's Exact tests were used.|||||<|0.05|||||||Fisher Exact|||The Pearson chi-square (χ2) or Fisher's Exact tests were used, at three different times (AD, D7, HD), to analyze the oral mucositis severity in the comparison between the LLLT and control groups. Statistical analysis was not performed for each grade of oral mucositis separately.||||<0.05
71928525|NCT02050373|143379032|OTHER|Student's t test was used to numerical variables with normal distribution. The Mann-Whitney test was used to compare the cytokine values of the two groups (control and laser). The Friedman test was used to indicate differences by comparing cytokine levels at different times of assessment within each group. The Friedman and Wilcoxon tests were used for paired analyzes of the saliva collection times in the groups. All tests were used to compare the groups at the three different times (AD, D7, HD).|||||<|0.05||||||p\<0,05|Wilcoxon (Mann-Whitney)|||||||<0.05
71928526|NCT01569074|143379068|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.23||||0.059|TWO_SIDED|80.0|0.07|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||0.39|0.07|0.059
71928527|NCT01569074|143379068|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.24||||0.054|TWO_SIDED|80.0|0.08|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.39|0.08|0.054
71689781|NCT00502853|142895933|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Student's t-test|||Change from Baseline at Week 12||||0.0003
71928528|NCT01569074|143379068|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.06||||0.57|TWO_SIDED|80.0|-0.2|0.08||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.08|-0.20|0.570
71928529|NCT01569074|143379068|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.262|TWO_SIDED|80.0|-0.02|0.29||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.29|-0.02|0.262
71928530|NCT01569074|143379069|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.11||||0.172|TWO_SIDED|80.0|0.01|0.21||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.21|0.01|0.172
71689782|NCT00502853|142895933|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
71928531|NCT01569074|143379069|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.06||||0.489|TWO_SIDED|80.0|-0.05|0.18||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.18|-0.05|0.489
71928532|NCT01569074|143379069|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.03||||0.704|TWO_SIDED|80.0|-0.08|0.15||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.15|-0.08|0.704
71928533|NCT01569074|143379070|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.17||||0.114|TWO_SIDED|80.0|0.03|0.31||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.31|0.03|0.114
71928534|NCT01569074|143379070|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.21||||0.035|TWO_SIDED|80.0|0.08|0.34||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.34|0.08|0.035
71928535|NCT01569074|143379070|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.07||||0.334|TWO_SIDED|80.0|-0.17|0.02||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.02|-0.17|0.334
71928536|NCT01569074|143379070|SUPERIORITY_OR_OTHER||Weighted difference in proportions|-0.04||||0.645|TWO_SIDED|80.0|-0.13|0.06||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.06|-0.13|0.645
71928537|NCT01569074|143379071|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.12||||0.028|TWO_SIDED|80.0|0.05|0.19||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.19|0.05|0.028
71928538|NCT01569074|143379071|SUPERIORITY_OR_OTHER||Weighted difference in proportions|0.14||||0.021|TWO_SIDED|80.0|0.06|0.22||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||0.22|0.06|0.021
71928539|NCT01569074|143379072|SUPERIORITY_OR_OTHER|||||||0.073||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.073
71928540|NCT01569074|143379072|SUPERIORITY_OR_OTHER|||||||0.065||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.065
71928541|NCT01569074|143379072|SUPERIORITY_OR_OTHER|||||||0.317||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.317
71928542|NCT01569074|143379072|SUPERIORITY_OR_OTHER|||||||0.263||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||||0.263
71928543|NCT01569074|143379073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.3||||0.033|TWO_SIDED|80.0|1.94|14.31|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied||14.31|1.94|0.033
71928544|NCT01569074|143379073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.1||||0.033|TWO_SIDED|80.0|1.92|13.61|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||13.61|1.92|0.033
71928545|NCT01569074|143379073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.5||||0.257|TWO_SIDED|80.0|0.89|6.89|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||6.89|0.89|0.257
71928546|NCT01569074|143379073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.481|TWO_SIDED|80.0|0.63|5.04|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.04|0.63|0.481
71928547|NCT01569074|143379074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.131|TWO_SIDED|80.0|1.12|4.2|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.20|1.12|0.131
71928548|NCT01569074|143379074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.423|TWO_SIDED|80.0|0.79|2.82|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.82|0.79|0.423
71928549|NCT01569074|143379074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.781|TWO_SIDED|80.0|0.45|1.67|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.67|0.45|0.781
71928550|NCT01569074|143379074|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.239|TWO_SIDED|80.0|0.95|3.44|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.44|0.95|0.239
71928551|NCT01569074|143379075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.169|TWO_SIDED|80.0|1.06|4.67||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ration \>1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.67|1.06|0.169
71928552|NCT01569074|143379075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.833|TWO_SIDED|80.0|0.45|1.78||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.78|0.45|0.833
71928553|NCT01569074|143379075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.614|TWO_SIDED|80.0|0.37|1.54||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.54|0.37|0.614
71928554|NCT01569074|143379075|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.748|TWO_SIDED|80.0|0.42|1.69||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of \>1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.69|0.42|0.748
71928555|NCT01569074|143379076|SUPERIORITY_OR_OTHER||Treatment difference|3.01||||0.087|TWO_SIDED|80.0|0.76|5.26|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.26|0.76|0.087
71928556|NCT01569074|143379076|SUPERIORITY_OR_OTHER||Treatment difference|0.25||||0.881|TWO_SIDED|80.0|-1.91|2.41|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||2.41|-1.91|0.881
71928557|NCT01569074|143379076|SUPERIORITY_OR_OTHER||Treatment difference|-0.42||||0.806|TWO_SIDED|80.0|-2.64|1.8|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.80|-2.64|0.806
71928558|NCT01569074|143379076|SUPERIORITY_OR_OTHER||Treatment difference|1.03||||0.548|TWO_SIDED|80.0|-1.17|3.23|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||3.23|-1.17|0.548
71928559|NCT01569074|143379077|SUPERIORITY_OR_OTHER||Treatment difference|3.12||||0.139|TWO_SIDED|80.0|0.42|5.82|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.82|0.42|0.139
71928560|NCT01569074|143379077|SUPERIORITY_OR_OTHER||Treatment difference|2.47||||0.223|TWO_SIDED|80.0|-0.13|5.07|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||5.07|-0.13|0.223
71928561|NCT01569074|143379077|SUPERIORITY_OR_OTHER||Treatment difference|-1.63||||0.432|TWO_SIDED|80.0|-4.3|1.04|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||1.04|-4.30|0.432
71928562|NCT01569074|143379077|SUPERIORITY_OR_OTHER||Treatment difference|1.45||||0.481|TWO_SIDED|80.0|-1.19|4.09|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.||4.09|-1.19|0.481
71928563|NCT02723786|143379078|OTHER||||||||||||||||||The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF \<30% was 0.07 (HPD 95% CI \[0.00,1.00\]). The posterior probability for the proportion of participants with DGF \<50% was 0.34 (HPD 95% CI \[0.00,1.00\]).|||
71928564|NCT00203892|143379097|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.028
71928565|NCT00203892|143379098|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
71928566|NCT02701049|143379101|OTHER|Among 109,994 patients who entered the ED during Mode 1, 19,742 had SOGI collected (18%). Among 88,143 patients who entered the ED during Mode 2, 3,630 had SOGI collected (4%).||||||||||||||||Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.|Results were compared to historical control population from an electronic health record database, no other data were collected for these participants.|||
71928567|NCT03359473|143379129|OTHER||Mean Difference (Net)|4.53|||||TWO_SIDED|90.0|-1.3|10.36|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||10.36|-1.30|
71928568|NCT03359473|143379129|OTHER||Mean Difference (Net)|7.8|||||TWO_SIDED|90.0|0.83|14.76|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.76|0.83|
71928569|NCT03359473|143379130|OTHER||Mean Difference (Net)|16.71|||||TWO_SIDED|90.0|9.86|23.56|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||23.56|9.86|
71928570|NCT03359473|143379130|OTHER||Mean Difference (Net)|5.35|||||TWO_SIDED|90.0|-4.09|14.78|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||14.78|-4.09|
71689783|NCT00502853|142895933|SUPERIORITY_OR_OTHER||Slope|-2.0857|STANDARD_ERROR_OF_MEAN|0.4965||0.0023|||||||Random coefficient model|||Trend over time||||0.0023
71689784|NCT00502853|142895934|SUPERIORITY_OR_OTHER|||||||0.3358|||||||Student's t-test|||Change from Baseline at Week 4||||0.3358
71689785|NCT00502853|142895934|SUPERIORITY_OR_OTHER|||||||0.9158|||||||Student's t-test|||Change from Baseline at Week 24||||0.9158
71928571|NCT03359473|143379131|OTHER||Mean Difference (Net)|5.17|||||TWO_SIDED|90.0|-4.67|15.01|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||15.01|-4.67|
71928572|NCT03359473|143379131|OTHER||Mean Difference (Net)|7.02|||||TWO_SIDED|90.0|0.46|13.58|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.58|0.46|
71928573|NCT03359473|143379132|OTHER||Mean Difference (Net)|5.9|||||TWO_SIDED|90.0|-1.4|13.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||13.2|-1.4|
71928574|NCT03359473|143379132|OTHER||Mean Difference (Net)|13.5|||||TWO_SIDED|90.0|1.6|25.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.5|1.6|
71928575|NCT03359473|143379133|OTHER||Mean Difference (Net)|20.7|||||TWO_SIDED|90.0|10.1|31.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||31.2|10.1|
71928576|NCT03359473|143379133|OTHER||Mean Difference (Net)|7.3|||||TWO_SIDED|90.0|-11.1|25.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||25.8|-11.1|
71928577|NCT03359473|143379134|OTHER||Mean Difference (Net)|8.0|||||TWO_SIDED|90.0|-2.5|18.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||18.4|-2.5|
71928578|NCT03359473|143379134|OTHER||Mean Difference (Net)|11.8|||||TWO_SIDED|90.0|-0.5|24.0|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline leg press strength, with Day as the repeated factor.|||24.0|-0.5|
71928579|NCT03359473|143379135|OTHER||Mean Difference (Net)|0.882|||||TWO_SIDED|90.0|0.643|1.121|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.121|0.643|
71928580|NCT03359473|143379135|OTHER||Mean Difference (Net)|0.291|||||TWO_SIDED|90.0|-0.156|0.738|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||0.738|-0.156|
71928581|NCT03359473|143379136|OTHER||Mean Difference (Net)|0.982|||||TWO_SIDED|90.0|0.629|1.334|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.334|0.629|
71928582|NCT03359473|143379136|OTHER||Mean Difference (Net)|1.127|||||TWO_SIDED|90.0|0.682|1.571|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.571|0.682|
71928583|NCT03359473|143379137|OTHER||Mean Difference (Net)|1.38|||||TWO_SIDED|90.0|0.964|1.795|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.795|0.964|
71928584|NCT03359473|143379137|OTHER||Mean Difference (Net)|1.124|||||TWO_SIDED|90.0|0.594|1.654|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline appendicular lean mass, with Day as the repeated factor.|||1.654|0.594|
71928585|NCT03359473|143379138|OTHER||Mean Difference (Net)|1.167|||||TWO_SIDED|90.0|0.677|1.658|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.658|0.677|
71928586|NCT03359473|143379138|OTHER||Mean Difference (Net)|0.923|||||TWO_SIDED|90.0|0.222|1.623|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||1.623|0.222|
71928587|NCT03359473|143379139|OTHER||Mean Difference (Net)|2.085|||||TWO_SIDED|90.0|1.493|2.678|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.678|1.493|
71928588|NCT03359473|143379139|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|90.0|0.801|2.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.600|0.801|
71928589|NCT03359473|143379140|OTHER||Mean Difference (Net)|2.108|||||TWO_SIDED|90.0|1.271|2.945|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||2.945|1.271|
71928590|NCT03359473|143379140|OTHER||Mean Difference (Net)|2.113|||||TWO_SIDED|90.0|0.949|3.277|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline total lean mass, with Day as the repeated factor.|||3.277|0.949|
71928591|NCT03359473|143379141|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
71928592|NCT03359473|143379141|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.4|0.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.5|-0.4|
71928593|NCT03359473|143379142|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|90.0|-0.6|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.6|
71928594|NCT03359473|143379142|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|90.0|-0.2|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.2|
71928595|NCT03359473|143379143|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|90.0|-0.4|0.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.9|-0.4|
71689786|NCT00502853|142895934|SUPERIORITY_OR_OTHER||Slope|0.003418|STANDARD_ERROR_OF_MEAN|0.02345||0.8877|||||||Random coefficient model|||Trend over time||||0.8877
71689787|NCT00502853|142895935|SUPERIORITY_OR_OTHER|||||||0.7624|||||||Student's t-test|||Change from Baseline at Week 4||||0.7624
71689788|NCT00502853|142895935|SUPERIORITY_OR_OTHER|||||||0.0212|||||||Student's t-test|||Change from Baseline at Week 24||||0.0212
71928596|NCT03359473|143379143|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|90.0|-0.5|0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline SPPB total score, with Day as the repeated factor.|||0.6|-0.5|
71928597|NCT03359473|143379144|OTHER||Mean Difference (Net)|-0.553|||||TWO_SIDED|90.0|-2.082|0.977|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.977|-2.082|
71928598|NCT03359473|143379144|OTHER||Mean Difference (Net)|-0.073|||||TWO_SIDED|90.0|-0.977|0.832|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.832|-0.977|
71928599|NCT03359473|143379145|OTHER||Mean Difference (Net)|-0.816|||||TWO_SIDED|90.0|-2.252|0.619|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.619|-2.252|
71928600|NCT03359473|143379145|OTHER||Mean Difference (Net)|0.163|||||TWO_SIDED|90.0|-1.096|1.422|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.422|-1.096|
71928601|NCT03359473|143379146|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|90.0|-2.668|0.748|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||0.748|-2.668|
71928602|NCT03359473|143379146|OTHER||Mean Difference (Net)|-1.937|||||TWO_SIDED|90.0|-5.208|1.333|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline time for chair rise, with Day as the repeated factor.|||1.333|-5.208|
71928603|NCT03359473|143379147|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|90.0|-0.314|0.233|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.233|-0.314|
71928604|NCT03359473|143379147|OTHER||Mean Difference (Net)|0.058|||||TWO_SIDED|90.0|-0.209|0.324|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.324|-0.209|
71928605|NCT03359473|143379148|OTHER||Mean Difference (Net)|-0.287|||||TWO_SIDED|90.0|-0.65|0.077|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.077|-0.650|
71928606|NCT03359473|143379148|OTHER||Mean Difference (Net)|-0.191|||||TWO_SIDED|90.0|-0.534|0.152|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.152|-0.534|
71928607|NCT03359473|143379149|OTHER||Mean Difference (Net)|-0.012|||||TWO_SIDED|90.0|-0.555|0.532|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.532|-0.555|
71928608|NCT03359473|143379149|OTHER||Mean Difference (Net)|-0.231|||||TWO_SIDED|90.0|-0.541|0.08|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline Time for fastest walk for 4 meter, with Day as the repeated factor.|||0.080|-0.541|
71689789|NCT00502853|142895935|SUPERIORITY_OR_OTHER||Slope|-4.2681|STANDARD_ERROR_OF_MEAN|2.0529||0.0712|||||||Random coefficient model|||Trend over time||||0.0712
71928609|NCT03359473|143379150|OTHER||Difference in Least Square Means|11.1|||||TWO_SIDED|90.0|-57.1|79.2|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||79.2|-57.1|
71928610|NCT03359473|143379150|OTHER||Difference in Least Square Means|-149.3|||||TWO_SIDED|90.0|-280.6|-18.1|||||Analysis was performed by ANCOVA model with Baseline CWR duration as the covariate adjusting for the treatment.|||-18.1|-280.6|
71928611|NCT03359473|143379151|OTHER||Difference in Least Square Means|-6.7|||||TWO_SIDED|90.0|-42.7|29.2|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||29.2|-42.7|
71928612|NCT03359473|143379151|OTHER||Difference in Least Square Means|-34.8|||||TWO_SIDED|90.0|-72.0|2.4|||||Analysis was performed by ANCOVA model with Baseline peak performance as the covariate adjusting for the treatment.|||2.4|-72.0|
71928613|NCT03359473|143379152|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|90.0|-2.6|1.9|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.9|-2.6|
71928614|NCT03359473|143379152|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-3.4|2.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||2.1|-3.4|
71928615|NCT03359473|143379153|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|90.0|-2.9|1.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||1.1|-2.9|
71928616|NCT03359473|143379153|OTHER||Mean Difference (Net)|2.2|||||TWO_SIDED|90.0|0.0|4.5|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and Baseline CAT score, with Day as the repeated factor.|||4.5|0.0|
71689790|NCT00502853|142895936|SUPERIORITY_OR_OTHER|||||||0.024|||||||Student's t-test|||Change from Baseline at Week 4||||0.0240
71689791|NCT00502853|142895936|SUPERIORITY_OR_OTHER|||||||0.0045|||||||Student's t-test|||Change from Baseline at Week 12||||0.0045
71928617|NCT03359473|143379154|OTHER||Mean Difference (Net)|-4.7|||||TWO_SIDED|90.0|-8.9|-0.6|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.6|-8.9|
71928618|NCT03359473|143379154|OTHER||Mean Difference (Net)|-2.1|||||TWO_SIDED|90.0|-7.2|3.1|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||3.1|-7.2|
71928619|NCT03359473|143379155|OTHER||Mean Difference (Net)|-4.9|||||TWO_SIDED|90.0|-9.5|-0.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||-0.4|-9.5|
71928620|NCT03359473|143379155|OTHER||Mean Difference (Net)|-4.1|||||TWO_SIDED|90.0|-10.3|2.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline difficulty scores, with Day as the repeated factor.|||2.2|-10.3|
71928621|NCT03359473|143379156|OTHER||Mean Difference (Net)|-3.1|||||TWO_SIDED|90.0|-5.9|-0.3|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||-0.3|-5.9|
71928622|NCT03359473|143379156|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|90.0|-4.6|4.2|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||4.2|-4.6|
71928623|NCT03359473|143379157|OTHER||Mean Difference (Net)|4.0|||||TWO_SIDED|90.0|-0.8|8.8|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||8.8|-0.8|
71928624|NCT03359473|143379157|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|90.0|-2.3|9.4|||||Analysis was performed by mixed model repeated measures including the covariates: treatment, Day, treatment\*Day and corresponding Baseline amount scores, with Day as the repeated factor.|||9.4|-2.3|
71928625|NCT03359473|143379158|OTHER||Mean Difference (Net)|-4.2|||||TWO_SIDED|90.0|-6.5|-1.9|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||-1.9|-6.5|
71928626|NCT03359473|143379158|OTHER||Mean Difference (Net)|-1.5|||||TWO_SIDED|90.0|-4.1|1.1|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.1|-4.1|
71928627|NCT03359473|143379159|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|90.0|-3.8|1.8|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||1.8|-3.8|
71928628|NCT03359473|143379159|OTHER||Mean Difference (Net)|-0.7|||||TWO_SIDED|90.0|-4.6|3.2|||||Analysis was performed by mixed model repeated measures including the covariates; treatment, Day, treatment\*Day and corresponding Baseline total scores, with Day as the repeated factor.|||3.2|-4.6|
71928629|NCT03359473|143379164|OTHER||Difference in Least Square Means|3.0|||||TWO_SIDED|90.0|-1.4|7.4|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||7.4|-1.4|
71928630|NCT03359473|143379164|OTHER||Difference in Least Square Means|2.1|||||TWO_SIDED|90.0|-2.3|6.5|||||Analysis was performed by ANCOVA model with Baseline total score as the covariate adjusting for the treatment.|||6.5|-2.3|
71928631|NCT03359473|143379165|OTHER||Difference in Least Square Means|2.6|||||TWO_SIDED|90.0|-5.0|10.1|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||10.1|-5.0|
71928632|NCT03359473|143379165|OTHER||Difference in Least Square Means|-0.5|||||TWO_SIDED|90.0|-8.4|7.5|||||Analysis was performed by ANCOVA model with Baseline symptoms score as the covariate adjusting for the treatment.|||7.5|-8.4|
71928633|NCT03359473|143379166|OTHER||Difference in Least Square Means|2.0|||||TWO_SIDED|90.0|-3.2|7.1|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||7.1|-3.2|
71928634|NCT03359473|143379166|OTHER||Difference in Least Square Means|0.5|||||TWO_SIDED|90.0|-5.6|6.5|||||Analysis was performed by ANCOVA model with Baseline activity score as the covariate adjusting for the treatment.|||6.5|-5.6|
71928635|NCT03359473|143379167|OTHER||Difference in Least Square Means|3.4|||||TWO_SIDED|90.0|-1.7|8.6|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||8.6|-1.7|
71928636|NCT03359473|143379167|OTHER||Difference in Least Square Means|3.5|||||TWO_SIDED|90.0|-0.7|7.7|||||Analysis was performed by ANCOVA model with Baseline impact score as the covariate adjusting for the treatment.|||7.7|-0.7|
71928637|NCT05302414|143379172|SUPERIORITY||Median Difference (Final Values)|12.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71928638|NCT05302414|143379172|SUPERIORITY||Median Difference (Final Values)|2.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71928639|NCT05302414|143379172|SUPERIORITY||Median Difference (Final Values)|6.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71928640|NCT05302414|143379173|SUPERIORITY||Median Difference (Final Values)|1.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For pretest at the 0 week||||<0.05
71928641|NCT05302414|143379173|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71928642|NCT05302414|143379173|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71928643|NCT05302414|143379174|SUPERIORITY||Median Difference (Final Values)|40.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71928644|NCT05302414|143379174|SUPERIORITY||Median Difference (Final Values)|45.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71928645|NCT05302414|143379174|SUPERIORITY||Median Difference (Final Values)|43.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71928646|NCT05302414|143379175|SUPERIORITY||Median Difference (Final Values)|0.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71928647|NCT05302414|143379175|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71928648|NCT05302414|143379175|SUPERIORITY||Median Difference (Final Values)|2.5||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71928649|NCT05302414|143379176|SUPERIORITY||Median Difference (Final Values)|6.75|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For the pretest at week 0.||||<0.05
71928650|NCT05302414|143379176|SUPERIORITY||Median Difference (Final Values)|0.25||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||0.05
71928651|NCT05302414|143379176|SUPERIORITY||Median Difference (Final Values)|0.0||||0.05|TWO_SIDED||||||Kruskal-Wallis|||For follow-up test at the 16 weeks.||||0.05
71928652|NCT05302414|143379177|SUPERIORITY||Median Difference (Final Values)|22.0|||<|0.05|TWO_SIDED||||||Kruskal-Wallis|||For posttest right after intervention at the 4 weeks.||||<0.05
71928653|NCT01610284|143379178|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.78|||<|0.001|TWO_SIDED|95.0|0.67|0.89|||Log Rank|||FAS-Full population||0.89|0.67|<0.001
71928654|NCT01610284|143379178|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.8||||0.003|TWO_SIDED|95.0|0.68|0.94|||Log Rank|||FAS-Main cohort||0.94|0.68|0.003
71928655|NCT01610284|143379178|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.76||||0.015|TWO_SIDED|95.0|0.6|0.97|||Log Rank|||FAS-PI3K pathway activated||0.97|0.60|0.015
71928656|NCT01610284|143379178|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.67|1.03||||||FAS-PI3K pathway non-activated||1.03|0.67|
71928657|NCT01610284|143379178|OTHER|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.52|0.94||||||FAS-PI3K pathway unknown||0.94|0.52|
71928658|NCT01610284|143379179|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.87||||0.045|TWO_SIDED|95.0|0.74|1.02|||Log Rank|||FAS-Full population||1.02|0.74|0.045
71928659|NCT01610284|143379179|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.91||||0.144|TWO_SIDED|95.0|0.75|1.09|||Log Rank|||FAS-Main cohort||1.09|0.75|0.144
71928660|NCT01610284|143379179|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.81|||||TWO_SIDED|95.0|0.61|1.08||||||FAS-PI3K pathway activated||1.08|0.61|
71928661|NCT01610284|143379179|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.77|1.24||||||FAS-PI3K pathway non-activated||1.24|0.77|
71928662|NCT01610284|143379179|OTHER|Comparison of overall survival (OS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.52|1.06||||||FAS-PI3K pathway unknown||1.06|0.52|
71928663|NCT04035694|143379187|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.08||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
71928664|NCT04035694|143379188|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.11
71928665|NCT04035694|143379189|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
71928666|NCT04035694|143379190|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.11||0.38|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.38
71928667|NCT04035694|143379191|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.07||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
71928668|NCT04035694|143379192|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.09|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.09
71928669|NCT04035694|143379193|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.08||0.4|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.40
71928670|NCT04035694|143379194|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.09||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
71928671|NCT04035694|143379195|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.66|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.66
71928672|NCT04035694|143379196|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
71928673|NCT04035694|143379197|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.15||0.52|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.52
71928674|NCT04035694|143379198|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.74|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.74
71928675|NCT04035694|143379199|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.21|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.21
71928676|NCT04035694|143379200|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.13||0.27|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.27
71928677|NCT04035694|143379201|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.07||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
71928678|NCT04035694|143379202|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.23|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.23
71928679|NCT04035694|143379203|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.05||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
71928680|NCT04035694|143379204|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.11||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
71928681|NCT04035694|143379205|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.99|STANDARD_ERROR_OF_MEAN|0.72||0.19|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.19
71928682|NCT04035694|143379206|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.59||0.92|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.92
71928683|NCT04035694|143379207|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.13||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
71928684|NCT04035694|143379208|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.16||0.81|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.81
71689792|NCT00502853|142895936|SUPERIORITY_OR_OTHER|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24||||0.0018
71928685|NCT04035694|143379209|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.1||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
71928686|NCT04035694|143379210|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.15||0.82|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.82
71928687|NCT04035694|143379211|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.97|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.97
71928688|NCT04035694|143379212|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.09||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
71928689|NCT04035694|143379213|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.69|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.69
71928690|NCT04035694|143379214|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.06||0.63|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.63
71928691|NCT04035694|143379215|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.79|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.79
71928692|NCT04035694|143379216|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.16||0.93|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.93
71928693|NCT04035694|143379217|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.98|STANDARD_ERROR_OF_MEAN|2.18||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
71928694|NCT04035694|143379218|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|5.0|STANDARD_ERROR_OF_MEAN|2.52||0.11|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.11
71928695|NCT04035694|143379219|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.93|STANDARD_ERROR_OF_MEAN|2.38||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
71928696|NCT04035694|143379220|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-2.24|STANDARD_ERROR_OF_MEAN|4.45||0.64|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.64
71928697|NCT04035694|143379221|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-6.46|STANDARD_ERROR_OF_MEAN|2.53||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
71928698|NCT04035694|143379222|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.23|STANDARD_ERROR_OF_MEAN|2.68||0.65|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.65
71928699|NCT04035694|143379223|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.65|STANDARD_ERROR_OF_MEAN|0.15|<|0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||<.01
71928700|NCT04035694|143379224|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.22||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.20
71928701|NCT04035694|143379225|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|2.79|STANDARD_ERROR_OF_MEAN|2.22||0.28|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.28
71928702|NCT04035694|143379226|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|1.56|STANDARD_ERROR_OF_MEAN|2.77||0.58|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.58
71928703|NCT04035694|143379227|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.1||0.49|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.49
71928704|NCT04035694|143379228|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.14||0.55|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.55
71928705|NCT04035694|143379229|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.09||0.54|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.54
71928706|NCT04035694|143379230|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.95|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.95
71928707|NCT04035694|143379231|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Median Difference (Net)|-4.25|STANDARD_ERROR_OF_MEAN|2.15||0.05|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.05
71928708|NCT04035694|143379232|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|3.84||0.75|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.75
71928709|NCT04035694|143379233|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.09||0.14|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.14
71928710|NCT04035694|143379234|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
71928711|NCT04035694|143379235|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.18|STANDARD_ERROR_OF_MEAN|0.06||0.01|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.01
71928712|NCT04035694|143379236|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.02
71928713|NCT04035694|143379237|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.14|STANDARD_ERROR_OF_MEAN|0.06||0.03|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.03
71928714|NCT04035694|143379238|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.13||0.57|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.57
71928715|NCT04035694|143379239|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.08||0.91|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.91
71928716|NCT04035694|143379240|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.11||0.72|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.72
71928717|NCT04035694|143379241|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.09||0.07|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.07
71928718|NCT04035694|143379242|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.1||0.56|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.56
71928719|NCT04035694|143379243|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.17
71928720|NCT04035694|143379244|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.12||0.89|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.89
71928721|NCT04035694|143379245|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.08||0.2|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||.20
71928722|NCT04035694|143379246|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.16||0.78|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.78
71928723|NCT04035694|143379247|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.41|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.41
71928724|NCT04035694|143379248|EQUIVALENCE|A series of multilevel regression models were estimated to determine the association between condition and each outcome, while controlling for the conditional non-independence of observations. Fixed effects included condition (intervention vs. control), the adolescent's pretest outcome score, and covariates (age, SES, race, sexual experience). The models included a random intercept for teacher and df were adjusted using the Satterthwaite adjustment.|Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.11||0.34|TWO_SIDED||||||Mixed Models Analysis|The df were adjusted to take into account random effects using Satterthwaite df adjustment for mixed models.||||||0.34
71928725|NCT01102972|143379249|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) for the difference in the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 24 was -12% or greater.|Treatment difference of proportions|0.33||||0.937||95.0|-7.97|8.64||The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.|Cochran-Mantel-Haenszel||95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.|||8.64|-7.97|0.937
71928726|NCT01856257|143379279|SUPERIORITY||Mean Difference (Final Values)|3.512||||0.544|TWO_SIDED|95.0|-7.999|15.024|||Mixed Models Analysis||The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.|||15.024|-7.999|0.544
71928727|NCT01856257|143379279|SUPERIORITY||Mean Difference (Final Values)|4.82||||0.531|TWO_SIDED|95.0|-10.481|20.121|||Mixed Models Analysis||P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.|||20.121|-10.481|0.531
71928728|NCT00318409|143379324|SUPERIORITY_OR_OTHER|||||||0.98||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.98
71928729|NCT00742859|143379330|OTHER||Hazard Ratio (HR)|0.14||||0.035|TWO_SIDED|95.0|0.017|1.14|||Log Rank|||Betrixaban 40mg compared to Warfarin||1.14|0.017|0.035
71928730|NCT00742859|143379330|OTHER||Hazard Ratio (HR)|0.711||||0.546|TWO_SIDED|95.0|0.225|2.24|||Log Rank|||Betrixaban 60mg compared to Warfarin||2.24|0.225|0.546
71928731|NCT00742859|143379330|OTHER||Hazard Ratio (HR)|0.755||||0.712|TWO_SIDED|95.0|0.239|2.39|||Log Rank|||Betrixaban 80mg compared to Warfarin||2.39|0.239|0.712
71928732|NCT00742859|143379331|OTHER||Hazard Ratio (HR)|0.508||||0.011|TWO_SIDED|95.0|0.301|0.856|||Log Rank|||Betrixaban 40mg compared to Warfarin||0.856|0.301|0.011
71928733|NCT00742859|143379331|OTHER||Hazard Ratio (HR)|0.767||||0.308|TWO_SIDED|95.0|0.481|1.22|||Log Rank|||Betrixaban 60mg compared to Warfarin||1.22|0.481|0.308
71928734|NCT00742859|143379331|OTHER||Hazard Ratio (HR)|0.551||||0.022|TWO_SIDED|95.0|0.332|0.914|||Log Rank|||Betrixaban 80mg compared to Warfarin||0.914|0.332|0.022
71928735|NCT00956709|143379332|SUPERIORITY_OR_OTHER|||||||0.56||||||Two patients in each group had incomplete block before sugery.|Wilcoxon (Mann-Whitney)|||||||0.56
71928736|NCT00956709|143379334|SUPERIORITY_OR_OTHER|||||||0.3354|||||||Wilcoxon (Mann-Whitney)|||||||0.3354
71928737|NCT00956709|143379335|SUPERIORITY_OR_OTHER|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||||||0.0445
71928738|NCT00116207|143379355|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.32
71928739|NCT00116207|143379355|SUPERIORITY_OR_OTHER|||||||0.045|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24-MONTH||||0.045
71928740|NCT00116207|143379356|SUPERIORITY_OR_OTHER|||||||0.52|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE||||0.52
71928741|NCT00116207|143379356|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.82
71928742|NCT00116207|143379357|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED|||||p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.24
71928743|NCT00116207|143379358|SUPERIORITY_OR_OTHER|||||||0.83|TWO_SIDED|||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH||||0.83
71928744|NCT00728988|143379359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9237|TWO_SIDED|95.0|-7.3|9.3|||Chi-squared, Corrected||95% confidence interval for the true difference in the incidence of MACE between the two treatment groups. Difference of incidence = usual care minus atorvastatin.|Total MACE: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.3|-7.3|0.9237
71928745|NCT00728988|143379359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-10.7|10.7|||Fisher Exact||Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin.|Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher's exact test was applied because the expected frequency of events was less than 5.||10.7|-10.7|1.0000
71928746|NCT00728988|143379359|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.9158|TWO_SIDED|95.0|-7.2|9.2|||Chi-squared, Corrected||Difference of incidence = usual care minus atorvastatin.|Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||9.2|-7.2|0.9158
71928747|NCT00728988|143379359|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.5104|1.6846|||Regression, Logistic|||Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care.||1.6846|0.5104|0.80
71928748|NCT00728988|143379359|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.96||||0.9|TWO_SIDED|95.0|0.4887|1.8836|||Regression, Logistic|||Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF \<=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care.||1.8836|0.4887|0.90
71928749|NCT00728988|143379359|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8494|TWO_SIDED||||||Log Rank|Survival analysis: Kaplan-Meier log rank test.||MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups.||||0.8494
71928750|NCT00728988|143379360|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||1|TWO_SIDED|95.0|-5.6|6.3|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care.|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.3|-5.6|1.0000
71928751|NCT00728988|143379361|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6||||0.7896|TWO_SIDED|95.0|-9.7|6.5|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care .|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||6.5|-9.7|0.7896
71928752|NCT00728988|143379362|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4||||0.631|TWO_SIDED|95.0|-10.1|5.4|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.4|-10.1|0.631
71928753|NCT00728988|143379362|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.518|TWO_SIDED|95.0|-12.1|5.5|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||5.5|-12.1|0.518
71928754|NCT00728988|143379362|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3||||0.236|TWO_SIDED|95.0|-9.6|12.0|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||12.0|-9.6|0.236
71928755|NCT00728988|143379363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.9||||0.425|TWO_SIDED|95.0|-6.2|15.9|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||15.9|-6.2|0.425
71928756|NCT00728988|143379363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.3||||0.392|TWO_SIDED|95.0|-6.1|16.7|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||16.7|-6.1|0.392
71928757|NCT00728988|143379363|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-10.7|10.9|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||10.9|-10.7|1.000
71928758|NCT00728988|143379364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.7||||0.529|TWO_SIDED|95.0|-9.6|4.3|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||4.3|-9.6|0.529
71928759|NCT00728988|143379364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.827|TWO_SIDED|95.0|-5.8|3.6|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.||3.6|-5.8|0.827
71928760|NCT00728988|143379364|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.616|TWO_SIDED|95.0|-10.3|11.5|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.||11.5|-10.3|0.616
71928761|NCT00728988|143379365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-29.53||||0.7554|TWO_SIDED|95.0|-215.87|156.81|||ANOVA|||8 hours post-PCI: difference (% change).||156.81|-215.87|0.7554
71928762|NCT00728988|143379365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|50.58||||0.7436|TWO_SIDED|95.0|-253.42|354.58|||ANOVA|||24 hours post-PCI: difference (% change).||354.58|-253.42|0.7436
71928763|NCT00728988|143379365|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-58.22||||0.4741|TWO_SIDED|95.0|-218.12|101.68|||ANOVA|||30 days post-PCI: difference (% change).||101.68|-218.12|0.4741
71928764|NCT00111007|143379390|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.906||||0.492|TWO_SIDED|95.0|0.627|1.31|||log rank test|||||1.310|0.627|0.492
71928765|NCT00111007|143379391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.996||||0.979|TWO_SIDED|95.0|0.744|1.333|||log rank test|||||1.333|0.744|0.979
71928766|NCT00111007|143379392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.863||||0.331|TWO_SIDED|95.0|0.641|1.162|||log rank test|||||1.162|0.641|0.331
71928767|NCT00111007|143379393|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.398||||0.146|TWO_SIDED|95.0|0.11|1.437|||log rank test|||||1.437|0.110|0.146
71928768|NCT00111007|143379394|SUPERIORITY_OR_OTHER|||||||0.389||95.0|||||Fisher Exact|||||||0.389
71928769|NCT02864953|143379397|SUPERIORITY||Odds Ratio (OR)|1.17|||=|0.415|TWO_SIDED|95.0|0.8|1.71||P-value was analyzed by ordinal logistic regression adjusting for covariates: region, and IRT stratification factors including rtPA usage (yes/no), thrombectomy usage (yes/no), use of ASPECTS for screening (yes/no), baseline NIHSS (\<=20 vs. \>20).|Regression, Logistic|||||1.71|0.80|=0.4150
71928770|NCT02864953|143379399|SUPERIORITY||Odds Ratio (OR)|1.07|||=|0.7413|TWO_SIDED|95.0|0.72|1.6||A logistic regression model was used to estimate an odds ratio (and 95% CI) of improvement on the mRS dichotomized as 0-4 vs. 5-6 at Day 90.|Regression, Logistic|||||1.60|0.72|=0.7413
71928771|NCT02864953|143379400|SUPERIORITY||Mean Difference (Final Values)|0.82|||=|0.1242|TWO_SIDED|95.0|-0.23|1.87||Analysis of Variance (ANOVA) was used to compare the two study arms to assess the treatment effects on midline shift.|ANOVA|||||1.87|-0.23|=0.1242
71928772|NCT03728257|143379402|SUPERIORITY|Change in average steps per day between baseline and 3 months was compared between the two groups.||||||0.8793||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.8793
71928773|NCT03728257|143379403|SUPERIORITY|Change in average steps per day between baseline and 6 months was compared between the two groups.||||||0.9597||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.9597
71928774|NCT03728257|143379404|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.3||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.30
71928775|NCT03728257|143379405|SUPERIORITY|Change in Berg balance between baseline and 3 months was compared between the two groups.||||||0.81||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.81
71928776|NCT03728257|143379406|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 3 months was compared between the two groups.||||||0.2262||||||a priori threshold for statistical significance is p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.2262
71928777|NCT03728257|143379407|SUPERIORITY|Change in 30 Second Sit-to-Stand Test between baseline and 6 months was compared between the two groups.||||||0.59||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.59
71928778|NCT03728257|143379408|SUPERIORITY|Change in SGRQ between baseline and 3 months was compared between the two groups.||||||0.26||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.26
71928779|NCT03728257|143379409|SUPERIORITY|Change in SGRQ between baseline and 6 months was compared between the two groups.||||||0.78||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.78
71928780|NCT03728257|143379410|SUPERIORITY|Change in MVPA between baseline and 3 months was compared between the two groups.||||||0.7073||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.7073
71928781|NCT03728257|143379411|SUPERIORITY|Change in MVPA between baseline and 6 months was compared between the two groups.||||||0.313||||||a priori threshold for statistical significance p \< 0.05|Wilcoxon (Mann-Whitney)|||||||0.313
71928782|NCT03728257|143379412|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.91||||||a priori threshold for statistical significance p \< 0.05|Chi-squared|||||||0.91
71928783|NCT03728257|143379413|SUPERIORITY|Change in count of participants with the same or improved stage of hypertension between baseline and 6 months.||||||0.72||||||a priori threshold of statistical significance p \< 0.05|Chi-squared|||||||0.72
71928784|NCT03205163|143379561|OTHER||GMR|1.35||||0.032|TWO_SIDED|95.0|1.04|1.77|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an analysis of variance (ANOVA) model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and geometric mean ratio (GMR) were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.77|1.04|0.032
71928785|NCT03205163|143379562|OTHER||GMR|1.17|||<|0.001|TWO_SIDED|95.0|1.09|1.25|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.25|1.09|<0.001
71928786|NCT03205163|143379563|OTHER||GMR|4.13|||<|0.001|TWO_SIDED|95.0|2.94|5.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.79|2.94|<0.001
71928787|NCT03205163|143379564|OTHER||GMR|3.24|||<|0.001|TWO_SIDED|95.0|2.76|3.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||3.79|2.76|<0.001
71928788|NCT03205163|143379565|OTHER||GMR|0.143|||<|0.001|TWO_SIDED|95.0|0.118|0.172|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.172|0.118|<0.001
71928789|NCT03205163|143379566|OTHER||GMR|0.153|||<|0.001|TWO_SIDED|95.0|0.138|0.17|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.170|0.138|<0.001
71928790|NCT03205163|143379567|OTHER||GMR|0.622||||0.003|TWO_SIDED|95.0|0.492|0.786|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.786|0.492|0.003
71928791|NCT03205163|143379568|OTHER||GMR|0.599|||<|0.001|TWO_SIDED|95.0|0.525|0.684|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||0.684|0.525|<0.001
71928792|NCT03205163|143379569|OTHER||GMR|7.0|||<|0.001|TWO_SIDED|95.0|5.78|8.48|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||8.48|5.78|<0.001
71928793|NCT03205163|143379570|OTHER||GMR|6.54|||<|0.001|TWO_SIDED|95.0|5.89|7.27|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||7.27|5.89|<0.001
71928794|NCT03205163|143379571|OTHER||GMR|4.54|||<|0.001|TWO_SIDED|95.0|3.64|5.66|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.66|3.64|<0.001
71928795|NCT03205163|143379572|OTHER||GMR|4.32|||<|0.001|TWO_SIDED|95.0|3.96|4.72|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.72|3.96|<0.001
71928796|NCT03205163|143379573|OTHER||GMR|1.36||||0.063|TWO_SIDED|95.0|0.978|1.89|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.89|0.978|0.063
71928797|NCT03205163|143379574|OTHER||GMR|1.18|||<|0.001|TWO_SIDED|95.0|1.1|1.26|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||1.26|1.10|<0.001
71928798|NCT03205163|143379575|OTHER||GMR|4.57|||<|0.001|TWO_SIDED|95.0|4.0|5.23|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||5.23|4.00|<0.001
71928799|NCT03205163|143379576|OTHER||GMR|4.46|||<|0.001|TWO_SIDED|95.0|4.16|4.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.||4.79|4.16|<0.001
71928800|NCT00584831|143379577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71689793|NCT00502853|142895936|SUPERIORITY_OR_OTHER||Slope|-0.1964|STANDARD_ERROR_OF_MEAN|0.04524||0.0019|||||||Random Coefficient Model|||Trend over time||||0.0019
71928801|NCT00584831|143379577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hyposthesis is that visual acuity is the same for all lens types.||||0.02
71928802|NCT00584831|143379577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928803|NCT00584831|143379577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928804|NCT00584831|143379577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928805|NCT00584831|143379577|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928806|NCT00584831|143379578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928807|NCT00584831|143379578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928808|NCT00584831|143379578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928809|NCT00584831|143379578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928810|NCT00584831|143379578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928811|NCT00584831|143379578|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928812|NCT00584831|143379579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|STANDARD_DEVIATION|0.13||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928813|NCT00584831|143379579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928814|NCT00584831|143379579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928815|NCT00584831|143379579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928816|NCT00584831|143379579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928817|NCT00584831|143379579|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928818|NCT00584831|143379580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.04|STANDARD_DEVIATION|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928819|NCT00584831|143379580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928820|NCT00584831|143379580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|STANDARD_DEVIATION|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928821|NCT00584831|143379580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928822|NCT00584831|143379580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928823|NCT00584831|143379580|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.||||0.02
71928824|NCT01371006|143379605|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|105.61|STANDARD_DEVIATION|22.0|||TWO_SIDED|90.0|90.81|122.82|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||122.82|90.81|
71928825|NCT01371006|143379606|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|116.12|STANDARD_DEVIATION|18.8|||TWO_SIDED|90.0|101.87|132.35|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz||132.35|101.87|
71928826|NCT01371006|143379607|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|71.83|STANDARD_DEVIATION|23.6|||TWO_SIDED|90.0|61.46|83.95|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||83.95|61.46|
71928827|NCT01371006|143379608|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|64.97|STANDARD_DEVIATION|30.2|||TWO_SIDED|90.0|53.32|79.16|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||79.16|53.32|
71928828|NCT01371006|143379609|NON_INFERIORITY_OR_EQUIVALENCE|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|54.31|STANDARD_DEVIATION|44.2|||TWO_SIDED|90.0|40.47|72.88|||ANOVA||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir||72.88|40.47|
71928829|NCT03515837|143379622|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0122|TWO_SIDED|95.0|0.65|0.97|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||0.97|0.65|0.0122
71928830|NCT03515837|143379623|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0362|TWO_SIDED|95.0|0.69|1.02|||Log Rank|One-sided p-value based on log-rank test stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.02|0.69|0.0362
71928831|NCT03515837|143379624|SUPERIORITY||Mean Difference (Final Values)|1.9|||||TWO_SIDED|95.0|-6.0|9.9|||||Based on Miettinen \& Nurminen method stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||9.9|-6.0|
71928832|NCT03515837|143379626|OTHER||Difference in LS Means|1.59|||||TWO_SIDED|95.0|-1.93|5.1|||||Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors PD-L1 expression, treatment history, and geographic region of the enrolling site as covariates.|||5.10|-1.93|
71928833|NCT03515837|143379627|OTHER||Hazard Ratio (HR)|0.93||||||95.0|0.68|1.27|||||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by PD-L1 expression; treatment history; geographic region of the enrolling site.|||1.27|0.68|
71928834|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
71928835|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7||||||95.0|-4.8|3.3||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated||3.3|-4.8|
71928836|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated||1.4|-1.4|
71928837|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-6.4|1.7||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated||1.7|-6.4|
71928838|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated||1.4|-1.4|
71928839|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
71928840|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.1||||||95.0|-1.4|6.8||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated||6.8|-1.4|
71928841|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated||2.7|-1.7|
71928842|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated||2.7|-1.7|
71928843|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-3.0||||||95.0|-8.0|2.5||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated||2.5|-8.0|
71928844|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-8.0||||||95.0|-14.9|-1.2||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||-1.2|-14.9|
71928845|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.4|-1.4|
71928846|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|2.7||||||95.0|-3.7|9.2||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||9.2|-3.7|
71928847|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.5|1.5||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||1.5|-1.5|
71928848|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.8||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-3.1|
71928849|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
71928850|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-5.8|1.8||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated||1.8|-5.8|
71928851|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated||2.7|-1.7|
71928852|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-2.3||||||95.0|-7.6|3.0||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-7.6|
71928853|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.3||||||95.0|-11.4|2.6||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||2.6|-11.4|
71928854|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.3||||||95.0|-5.0|4.3||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||4.3|-5.0|
71928855|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.6|3.5||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.5|-3.6|
71928856|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.5||||||95.0|-3.1|3.0||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||3.0|-3.1|
71928857|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8||||||95.0|-3.1|1.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated||1.9|-3.1|
71928858|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.9||||||95.0|-3.2|5.0||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||5.0|-3.2|
71928859|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-4.5||||||95.0|-13.2|4.4||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.4|-13.2|
71928860|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|2.8||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated||2.8|-1.7|
71928861|NCT00366678|143379666|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.2||||||95.0|-3.1|4.5||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated||4.5|-3.1|
71928862|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
71928863|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.9||||||95.0|-0.9|4.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.9|-0.9|
71928864|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
71928865|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
71928866|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|1.4||||||95.0|-1.1|5.9||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.9|-1.1|
71928867|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-5.8|2.7||||||For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.7|-5.8|
71928868|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.9|-1.7|
71928869|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-1.8|3.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||3.3|-1.8|
71928870|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.0||||||95.0|-3.3|3.0||||||For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.0|-3.3|
71928871|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-0.4||||||95.0|-2.5|2.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.4|-2.5|
71928872|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.8|4.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.8|
71928873|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.1|-4.9|
71928874|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.8|-1.8|
71928875|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|-1.1|5.7||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.7|-1.1|
71928876|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-1.0||||||95.0|-5.5|2.8||||||For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||2.8|-5.5|
71928877|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.2||||||95.0|-3.1|4.7||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.7|-3.1|
71928878|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-2.9|5.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||5.4|-2.9|
71928879|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-0.3||||||95.0|-5.5|4.4||||||For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||4.4|-5.5|
71928880|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.4||||||95.0|-1.8|3.9||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.9|-1.8|
71928881|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|0.5||||||95.0|-1.9|4.4||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated||4.4|-1.9|
71928882|NCT00366678|143379667|SUPERIORITY_OR_OTHER||Difference|-0.1||||||95.0|-4.1|3.7||||||For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated||3.7|-4.1|
71928883|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.73|1.03||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.73|
71928884|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.83||||||95.0|0.67|1.03||||||For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.03|0.67|
71928885|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|1.04||||||95.0|0.86|1.26||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.26|0.86|
71928886|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.93||||||95.0|0.77|1.13||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.13|0.77|
71928887|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|1.07||||||95.0|0.82|1.4||||||For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.40|0.82|
71928888|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.87||||||95.0|0.69|1.1||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.10|0.69|
71928889|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.8||||||95.0|0.68|0.94||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.94|0.68|
71928890|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.71||||||95.0|0.59|0.85||||||For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.85|0.59|
71928891|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|1.13||||||95.0|0.95|1.33||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.33|0.95|
71928892|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.88||||||95.0|0.73|1.06||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.06|0.73|
71928893|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.72||||||95.0|0.58|0.9||||||For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.90|0.58|
71928894|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|1.22||||||95.0|1.0|1.49||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.49|1.00|
71928895|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.82||||||95.0|0.69|0.97||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||0.97|0.69|
71928896|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.86||||||95.0|0.69|1.08||||||For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.08|0.69|
71928897|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.95||||||95.0|0.78|1.15||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.15|0.78|
71928898|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|1.26||||||95.0|1.0|1.59||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.59|1.00|
71928899|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.91||||||95.0|0.68|1.2||||||For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.20|0.68|
71928900|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|1.39||||||95.0|1.08|1.79||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.79|1.08|
71928901|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.81||||||95.0|0.67|1.0||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.00|0.67|
71928902|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.85||||||95.0|0.67|1.07||||||For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated||1.07|0.67|
71928903|NCT00366678|143379668|SUPERIORITY_OR_OTHER||Ratio|0.96||||||95.0|0.78|1.19||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated||1.19|0.78|
71928904|NCT00366678|143379671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.66|0.9||||||For Diphtheria the GMC ratio was calculated||0.90|0.66|
71928905|NCT00366678|143379671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.82|
71928906|NCT00366678|143379671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.8||||||95.0|0.67|0.97||||||For Diphtheria the GMC ratio was calculated||0.97|0.67|
71928907|NCT00366678|143379671|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Tetanus the GMC ratio was calculated||1.08|0.69|
71928908|NCT00366678|143379672|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.73|1.14||||||For Hib (PRP) the GMC ratio was calculated||1.14|0.73|
71928909|NCT00366678|143379672|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.04||||||95.0|0.82|1.32||||||For Hib (PRP) the GMC ratio was calculated||1.32|0.82|
71928910|NCT00366678|143379673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.71|1.09||||||For Polio Type 1 the GMC ratio was calculated||1.09|0.71|
71928911|NCT00366678|143379673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.66|1.03||||||For Polio Type 2 the GMC ratio was calculated||1.03|0.66|
71928912|NCT00366678|143379673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.59|1.02||||||For Polio Type 3 the GMC ratio was calculated||1.02|0.59|
71928913|NCT00366678|143379673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.72|1.41||||||For Polio Type 1 the GMC ratio was calculated||1.41|0.72|
71928914|NCT00366678|143379673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.72|1.34||||||For Polio Type 2 the GMC ratio was calculated||1.34|0.72|
71928915|NCT00366678|143379673|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.84||||||95.0|0.6|1.17||||||For Polio Type 3 the GMC ratio was calculated||1.17|0.60|
71928916|NCT00366678|143379674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.78|0.98||||||For Pertussis - FHA the GMC ratio was calculated||0.98|0.78|
71928917|NCT00366678|143379674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.92||||||95.0|0.84|1.02||||||For Pertussis - PT the GMC ratio was calculated||1.02|0.84|
71928918|NCT00366678|143379674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.72|1.0||||||For Pertussis - FHA the GMC ratio was calculated||1.00|0.72|
71928919|NCT00366678|143379674|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.86|1.14||||||For Pertussis - PT the GMC ratio was calculated||1.14|0.86|
71928920|NCT02545868|143379684|SUPERIORITY||normal distribution approximation|-30.7|||||TWO_SIDED|95.0|-50.5|-10.8||||||Difference in positive response, Group A minus Group B||-10.8|-50.5|
71928921|NCT02545868|143379685|SUPERIORITY||normal distribution approximation|-36.4|||||TWO_SIDED|95.0|-56.0|-16.7||||||Difference in positive response, Group A minus Group B||-16.7|-56.0|
71928922|NCT02545868|143379686|SUPERIORITY||normal distribution approximation|-47.0|||||TWO_SIDED|95.0|-63.2|-30.7||||||Difference in positive response, Group A minus Group B||-30.7|-63.2|
71928923|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-50.7|||||TWO_SIDED|95.0|-62.7|-38.8||||||Serotype 1||-38.8|-62.7|
71928924|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-43.3|||||TWO_SIDED|95.0|-56.5|-30.1||||||Serotype 2||-30.1|-56.5|
71928925|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-48.0|||||TWO_SIDED|95.0|-65.2|-30.9||||||Serotype 3||-30.9|-65.2|
71928926|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 4||-48.4|-77.2|
71928927|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-53.8|||||TWO_SIDED|95.0|-68.0|-39.7||||||Serotype 5||-39.7|-68.0|
71928928|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-37.5|||||TWO_SIDED|95.0|-54.4|-20.7||||||Serotype 6B||-20.7|-54.4|
71928929|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-73.1|-43.6||||||Serotype 7F||-43.6|-73.1|
71928930|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-32.9|||||TWO_SIDED|95.0|-45.7|-20.1||||||Serotype 8||-20.1|-45.7|
71928931|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 9N||-30.4|-62.5|
71928932|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-40.4|||||TWO_SIDED|95.0|-55.7|-25.1||||||Serotype 9V||-25.1|-55.7|
71928933|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-62.8|||||TWO_SIDED|95.0|-77.2|-48.4||||||Serotype 10A||-48.4|-77.2|
71928934|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-69.4|-35.6||||||Serotype 11A||-35.6|-69.4|
71928935|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-72.8|-38.3||||||Serotype 12F||-38.3|-72.8|
71928936|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.4|-9.7||||||Serotype 14||-9.7|-41.4|
71928937|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-47.9|||||TWO_SIDED|95.0|-63.9|-32.0||||||Serotype 15B||-32.0|-63.9|
71928938|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-56.9|||||TWO_SIDED|95.0|-72.4|-41.4||||||Serotype 17F||-41.4|-72.4|
71928939|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-52.4|||||TWO_SIDED|95.0|-67.4|-37.3||||||Serotype 18C||-37.3|-67.4|
71928940|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-46.4|||||TWO_SIDED|95.0|-62.5|-30.4||||||Serotype 19A||-30.4|-62.5|
71928941|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-68.8|-36.1||||||Serotype 19F||-36.1|-68.8|
71928942|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-61.5|||||TWO_SIDED|95.0|-77.5|-45.4||||||Serotype 20||-45.4|-77.5|
71928943|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-71.7|-42.0||||||Serotype 22F||-42.0|-71.7|
71928944|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-33.2|||||TWO_SIDED|95.0|-51.7|-14.6||||||Serotype 23F||-14.6|-51.7|
71928945|NCT02545868|143379690|SUPERIORITY||Normal Distribution Approximation|-47.8|||||TWO_SIDED|95.0|-62.2|-33.5||||||Serotype 33F||-33.5|-62.2|
71928946|NCT02545868|143379691|SUPERIORITY||Normal Distribution Approximation|-13.4|||||TWO_SIDED|95.0|-21.6|-5.3||||||||-5.3|-21.6|
71928947|NCT02545868|143379692|SUPERIORITY||Normal Distribution Approximation|-59.7|||||TWO_SIDED|95.0|-72.6|-46.8||||||||-46.8|-72.6|
71928948|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-45.2|||||TWO_SIDED|95.0|-62.7|-27.6||||||Serotype 1- Difference in positive response, Group A1 minus Group B||-27.6|-62.7|
71928949|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 2- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
71928950|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-49.8|||||TWO_SIDED|95.0|-70.4|-29.2||||||Serotype 3- Difference in positive response, Group A1 minus Group B||-29.2|-70.4|
71928951|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-56.0|||||TWO_SIDED|95.0|-75.7|-36.3||||||Serotype 4- Difference in positive response, Group A1 minus Group B||-36.3|-75.7|
71928952|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-58.3|||||TWO_SIDED|95.0|-76.4|-40.3||||||Serotype 5- Difference in positive response, Group A1 minus Group B||-40.3|-76.4|
71928953|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-34.0|||||TWO_SIDED|95.0|-55.7|-12.2||||||Serotype 6B- Difference in positive response, Group A1 minus Group B||-12.2|-55.7|
71928954|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 7F- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
71928955|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-42.2|||||TWO_SIDED|95.0|-60.6|-23.8||||||Serotype 8- Difference in positive response, Group A1 minus Group B||-23.8|-60.6|
71928956|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-37.2|||||TWO_SIDED|95.0|-58.9|-15.5||||||Serotype 9N- Difference in positive response, Group A1 minus Group B||-15.5|-58.9|
71928957|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-36.6|||||TWO_SIDED|95.0|-57.3|-16.0||||||Serotype 9V- Difference in positive response, Group A1 minus Group B||-16.0|-57.3|
71928958|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-62.1|||||TWO_SIDED|95.0|-80.8|-43.5||||||Serotype 10A- Difference in positive response, Group A1 minus Group B||-43.5|-80.8|
71928959|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-50.1|||||TWO_SIDED|95.0|-71.0|-29.2||||||Serotype 11A- Difference in positive response, Group A1 minus Group B||-29.2|-71.0|
71928960|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-56.8|||||TWO_SIDED|95.0|-76.9|-36.8||||||Serotype 12F- Difference in positive response, Group A1 minus Group B||-36.8|-76.9|
71928961|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-20.8|||||TWO_SIDED|95.0|-41.4|-0.2||||||Serotype 14- Difference in positive response, Group A1 minus Group B||-0.2|-41.4|
71928962|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-52.8|||||TWO_SIDED|95.0|-72.8|-32.7||||||Serotype 15B- Difference in positive response, Group A1 minus Group B||-32.7|-72.8|
71928963|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 17F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
71928964|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-42.5|||||TWO_SIDED|95.0|-61.8|-23.2||||||Serotype 18C- Difference in positive response, Group A1 minus Group B||-23.2|-61.8|
71928965|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-30.2|||||TWO_SIDED|95.0|-50.6|-9.7||||||Serotype 19A- Difference in positive response, Group A1 minus Group B||-9.7|-50.6|
71928966|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-46.3|||||TWO_SIDED|95.0|-66.8|-25.8||||||Serotype 19F- Difference in positive response, Group A1 minus Group B||-25.8|-66.8|
71928967|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-79.0|-40.0||||||Serotype 20- Difference in positive response, Group A1 minus Group B||-40.0|-79.0|
71928968|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-52.5|||||TWO_SIDED|95.0|-72.1|-32.8||||||Serotype 22F- Difference in positive response, Group A1 minus Group B||-32.8|-72.1|
71928969|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-28.1|||||TWO_SIDED|95.0|-50.7|-5.4||||||Serotype 23F- Difference in positive response, Group A1 minus Group B||-5.4|-50.7|
71928970|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-49.0|||||TWO_SIDED|95.0|-68.2|-29.7||||||Serotype 33F- Difference in positive response, Group A1 minus Group B||-29.7|-68.2|
71928971|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-78.1|-45.4||||||Serotype 1- Difference in positive response, Group A2 minus Group B||-45.4|-78.1|
71928972|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 2- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
71928973|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-55.9|||||TWO_SIDED|95.0|-75.3|-36.5||||||Serotype 3- Difference in positive response, Group A2 minus Group B||-36.5|-75.3|
71928974|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-64.7|||||TWO_SIDED|95.0|-82.6|-46.8||||||Serotype 4- Difference in positive response, Group A2 minus Group B||-46.8|-82.6|
71928975|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-70.6|-35.3||||||Serotype 5- Difference in positive response, Group A2 minus Group B||-35.3|-70.6|
71928976|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 6B- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
71928977|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-76.7|-40.9||||||Serotype 7F- Difference in positive response, Group A2 minus Group B||-40.9|-76.7|
71928978|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-29.4|||||TWO_SIDED|95.0|-46.1|-12.7||||||Serotype 8- Difference in positive response, Group A2 minus Group B||-12.7|-46.1|
71928979|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-35.3|||||TWO_SIDED|95.0|-56.4|-14.2||||||Serotype 9N- Difference in positive response, Group A2 minus Group B||-14.2|-56.4|
71928980|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-58.2|-18.2||||||Serotype 9V- Difference in positive response, Group A2 minus Group B||-18.2|-58.2|
71928981|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.8|-43.7||||||Serotype 10A- Difference in positive response, Group A2 minus Group B||-43.7|-79.8|
71928982|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-38.2|||||TWO_SIDED|95.0|-59.3|-17.2||||||Serotype 11A- Difference in positive response, Group A2 minus Group B||-17.2|-59.3|
71928983|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-78.0|-39.6||||||Serotype 12F- Difference in positive response, Group A2 minus Group B||-39.6|-78.0|
71928984|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-17.6|||||TWO_SIDED|95.0|-37.4|2.1||||||Serotype 14- Difference in positive response, Group A2 minus Group B||2.1|-37.4|
71928985|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-69.6|-30.4||||||Serotype 15B- Difference in positive response, Group A2 minus Group B||-30.4|-69.6|
71928986|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-44.1|||||TWO_SIDED|95.0|-64.0|-24.2||||||Serotype 17F- Difference in positive response, Group A2 minus Group B||-24.2|-64.0|
71928987|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-61.8|||||TWO_SIDED|95.0|-79.4|-44.2||||||Serotype 18C- Difference in positive response, Group A2 minus Group B||-44.2|-79.4|
71928988|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-52.9|||||TWO_SIDED|95.0|-72.3|-33.6||||||Serotype 19A- Difference in positive response, Group A2 minus Group B||-33.6|-72.3|
71928989|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-58.8|||||TWO_SIDED|95.0|-77.6|-40.1||||||Serotype 19F- Difference in positive response, Group A2 minus Group B||-40.1|-77.6|
71928990|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-70.6|||||TWO_SIDED|95.0|-87.4|-53.8||||||Serotype 20- Difference in positive response, Group A2 minus Group B||-53.8|-87.4|
71928991|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-67.6|||||TWO_SIDED|95.0|-84.8|-50.5||||||Serotype 22F- Difference in positive response, Group A2 minus Group B||-50.5|-84.8|
71928992|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-47.1|||||TWO_SIDED|95.0|-68.0|-26.1||||||Serotype 23F- Difference in positive response, Group A2 minus Group B||-26.1|-68.0|
71928993|NCT02545868|143379694|SUPERIORITY||Normal Distribution Approximation|-50.0|||||TWO_SIDED|95.0|-68.5|-31.5||||||Serotype 33F- Difference in positive response, Group A2 minus Group B||-31.5|-68.5|
71928994|NCT02545868|143379696|SUPERIORITY||Normal Distribution Approximation|-25.5|||||TWO_SIDED|95.0|-41.6|-9.5||||||Strain = H1N1CA09 (Group A2 minus Group B)||-9.5|-41.6|
71928995|NCT02545868|143379696|SUPERIORITY||Normal Distribution Approximation|-14.0|||||TWO_SIDED|95.0|-35.2|7.3||||||Strain = BPHU13 (Group A2 minus Group B)||7.3|-35.2|
71928996|NCT02545868|143379696|SUPERIORITY||Normal Distribution Approximation|-25.9|||||TWO_SIDED|95.0|-45.5|-6.4||||||Strain = H3N2SW13 (Group A2 minus Group B)||-6.4|-45.5|
71928997|NCT02545868|143379696|SUPERIORITY||Normal Distribution Approximation|-19.4|||||TWO_SIDED|95.0|-50.7|11.8||||||Strain = BBRIS08 (Group A2 minus Group B)||11.8|-50.7|
71928998|NCT02545868|143379696|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
71928999|NCT02545868|143379697|SUPERIORITY||Normal Distribution Approximation|-41.8|||||TWO_SIDED|95.0|-61.9|-21.7||||||Strain = H1N1CA09 (Group A2 minus Group B)||-21.7|-61.9|
71929000|NCT02545868|143379697|SUPERIORITY||Normal Distribution Approximation|-37.6|||||TWO_SIDED|95.0|-59.7|-15.5||||||Strain = BPHU13 (Group A2 minus Group B)||-15.5|-59.7|
71929001|NCT02545868|143379697|SUPERIORITY||Normal Distribution Approximation|-59.5|||||TWO_SIDED|95.0|-78.2|-40.7||||||Strain = H3N2SW13 (Group A2 minus Group B)||-40.7|-78.2|
71929002|NCT02545868|143379697|SUPERIORITY||Normal Distribution Approximation|-45.6|||||TWO_SIDED|95.0|-76.0|-15.1||||||Strain = BBRIS08 (Group A2 minus Group B)||-15.1|-76.0|
71929003|NCT02545868|143379697|SUPERIORITY||Normal Distribution Approximation|-3.3|||||TWO_SIDED|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)||42.7|-49.4|
71929004|NCT02545868|143379698|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B||-42.3|-80.2|
71929005|NCT02545868|143379698|SUPERIORITY||Normal Distribution Approximation|-54.8|||||TWO_SIDED|95.0|-75.3|-34.4||||||Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B||-34.4|-75.3|
71929006|NCT02545868|143379698|SUPERIORITY||Normal Distribution Approximation|-82.3|||||TWO_SIDED|95.0|-97.1|-67.5||||||Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B||-67.5|-97.1|
71929007|NCT02545868|143379698|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B||-6.1|-67.2|
71929008|NCT02545868|143379698|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B||50.5|-63.8|
71929009|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-61.3|||||TWO_SIDED|95.0|-80.2|-42.3||||||Strain = H1N1CA09 (Group A2 minus Group B) \[FDA\]||-42.3|-80.2|
71929010|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-46.0|||||TWO_SIDED|95.0|-88.0|-4.0||||||Strain = H1N1CA09 (Group A2 minus Group B) \[Protocol\]||-4.0|-88.0|
71929011|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-57.9|||||TWO_SIDED|95.0|-77.7|-38.1||||||Strain = BPHU13 (Group A2 minus Group B) \[FDA\]||-38.1|-77.7|
71929012|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-55.6|||||TWO_SIDED|95.0|-88.0|-23.1||||||Strain = BPHU13 (Group A2 minus Group B) \[Protocol\]||-23.1|-88.0|
71929013|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-78.5|||||TWO_SIDED|95.0|-94.8|-62.2||||||Strain = H3N2SW13 (Group A2 minus Group B) \[FDA\]||-62.2|-94.8|
71929014|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-57.8|||||TWO_SIDED|95.0|-100.0|-13.4||||||Strain = H3N2SW13 (Group A2 minus Group B) \[Protocol\]||-13.4|-100.0|
71929015|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-36.7|||||TWO_SIDED|95.0|-67.2|-6.1||||||Strain = BBRIS08 (Group A2 minus Group B) \[FDA\]||-6.1|-67.2|
71929016|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-25.0|||||TWO_SIDED|95.0|-67.4|17.4||||||Strain = BBRIS08 (Group A2 minus Group B) \[Protocol\]||17.4|-67.4|
71929017|NCT02545868|143379699|SUPERIORITY||Normal Distribution Approximation|-6.7|||||TWO_SIDED|95.0|-63.8|50.5||||||Strain = AHK4801 (Group A2 minus Group B) \[FDA\]||50.5|-63.8|
71929018|NCT01777191|143379725|SUPERIORITY_OR_OTHER_LEGACY|||||||0.248|TWO_SIDED||||||Fisher Exact|||||||0.248
71929019|NCT01932801|143379728|SUPERIORITY|||||||0.461||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model stats: χ2(18, N=308) = 17.93, CFI = 1.00, RMSEA \< .001, SRMR = .07||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.461
71929020|NCT01932801|143379728|SUPERIORITY||Slope|-0.48||||0.01|TWO_SIDED|95.0|-0.79|-0.18||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period|z score for parameters||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.18|-.79|.01
71929021|NCT01932801|143379728|SUPERIORITY||Slope|-0.41||||0.01|TWO_SIDED|95.0|-0.67|-0.15|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.15|-.67|.01
71929022|NCT01932801|143379728|SUPERIORITY||Slope|-0.23||||0.19|TWO_SIDED|95.0|-0.52|0.06|||z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control (one of three dummy-coded variables) during treatment period|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.06|-.52|.19
71929023|NCT01932801|143379729|SUPERIORITY|||||||0.347||||||Denotes exact fit for the omnibus model|Chi-squared|complete omnibus model statistics: χ2(20, N=308) = 21.89, CFI = 1.00, RMSEA = .02, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.347
71929024|NCT01932801|143379729|SUPERIORITY||Slope|-2.22||||0.002|TWO_SIDED|95.0|-3.39|-1.06||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-1.06|-3.39|.002
71929025|NCT01932801|143379729|SUPERIORITY||Slope|-0.82||||0.208|TWO_SIDED|95.0|-1.89|0.25||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||.25|-1.89|.208
71929026|NCT01932801|143379729|SUPERIORITY||Slope|-1.58||||0.025|TWO_SIDED|95.0|-2.73|-0.42||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.42|-2.73|.025
71929027|NCT01932801|143379730|SUPERIORITY|||||||0.028||||||"p value reflects omnibus model close fit"|Chi-squared|χ2(13, N=308) = 24.34, CFI = .98, RMSEA = .05, SRMR = .03||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.028
71929028|NCT01932801|143379730|SUPERIORITY||Slope|-4.42||||0.047|TWO_SIDED|95.0|-8.09|-0.76||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.76|-8.09|.047
71929029|NCT01932801|143379730|SUPERIORITY||Slope|-5.95||||0.009|TWO_SIDED|95.0|-9.72|-2.19||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-2.19|-9.72|.009
71929030|NCT01932801|143379730|SUPERIORITY||Slope|-4.12||||0.072|TWO_SIDED|95.0|-7.88|-0.36||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|z||Linear effects of HaRT-A only compared to services-as usual control during treatment period (one of three dummy-coded variables)|"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model. For more familiar formats, please see the related publications page, especially see https://doi.org/10.1016/s2215-0366(20)30489-2"||-.36|-7.88|.072
71929031|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.12|STANDARD_ERROR_OF_MEAN|0.24||0.6|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.6
71929032|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.04|STANDARD_ERROR_OF_MEAN|0.18||0.83|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.83
71929033|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.02|STANDARD_ERROR_OF_MEAN|0.17||0.89|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol frequency.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.89
71929034|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.01|STANDARD_ERROR_OF_MEAN|0.02||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
71929035|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.003|STANDARD_ERROR_OF_MEAN|0.02||0.87|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the placebo vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.87
71929036|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.002|STANDARD_ERROR_OF_MEAN|0.02||0.91|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all four treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.91
71929037|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.24|STANDARD_ERROR_OF_MEAN|0.38||0.54|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the XR-NTX vs control group effects on alcohol related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.54
71929038|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.32||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the placebo vs control effects on alcohol-related harm.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
71929039|NCT01932801|143379731|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|0.06|STANDARD_ERROR_OF_MEAN|0.29||0.84|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails all 4 treatment arms; however, this specific contrast is for the HaRT-A vs control group effects on alcohol related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of readiness for change slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.84
71929040|NCT01932801|143379732|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.41|STANDARD_ERROR_OF_MEAN|0.9||0.65|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on alcohol frequency and alcohol craving (PACS).|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.65
71929041|NCT01932801|143379732|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.03|STANDARD_ERROR_OF_MEAN|0.04||0.46|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails 2 treatment arms: XR-NTX vs placebo effects on craving and alcohol quantity.|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of the alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.46
71929042|NCT01932801|143379732|OTHER|Mediation tested using the product of coefficients (a\*b) approach (MacKinnon et al, 2002).|Slope|-0.57|STANDARD_ERROR_OF_MEAN|0.75||0.45|TWO_SIDED||||||z||We used growth modeling to test mediators of the treatment effect, truncated for during-treatment effects. This analysis entails two treatment arms: XR-NTX vs placebo effects on craving and alcohol-related harm|This was a mediation analysis (i.e., multiplication of regression coefficients for the regression of alcohol craving (PACS) slope on group (a-paths) and for the regression of alcohol outcome slopes on readiness (b-paths), where a\*b is considered the mediated effect) for during-treatment effects (baseline to week 12).||||.45
71929043|NCT01932801|143379733|SUPERIORITY|||||||0.95||||||Denotes exact fit for the omnibus model|Chi-squared|Complete omnibus model : χ2(12, N=308) = .75, CFI = 1.00, RMSEA \< .001, SRMR = .008||"We used piecewise growth modeling to test various treatment arm effects on this outcome. Because there is currently no appropriate way to report on piecewise growth models in clinicaltrials.gov reporting tables, we are reporting the omnibus model statistics on this page called analysis 1 and select parameters representing certain treatment arm effects on subsequent analysis pages. However, we note these do not constitute separate analyses, but various parameters within a single SEM model."||||.95
71929044|NCT01932801|143379733|SUPERIORITY||Slope|-0.04||||0.75|TWO_SIDED|95.0|-0.24|0.16||Linear effects of HaRT-A+XR-NTX compared to services-as usual control during treatment period (one of three dummy-coded variables)|Chi-squared|||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.16|-.24|.75
71929045|NCT01932801|143379733|SUPERIORITY||Slope|-0.15||||0.2|TWO_SIDED|95.0|-0.34|0.04|||Chi-squared|Linear effects of HaRT-A+placebo compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.04|-.34|.20
71929046|NCT01932801|143379733|SUPERIORITY||Slope|0.1||||0.39|TWO_SIDED|95.0|-0.09|0.29|||Chi-squared|Linear effects of HaRT-A compared to services-as usual control during treatment period (one of three dummy-coded variables)||"These are select parameters for treatment arm effects that are subordinate to the omnibus model statistics in the table called analysis 1. These are not separate analyses, but select parameters within a single SEM model."||.29|-.09|.39
71929047|NCT01932801|143379734|SUPERIORITY||incident rate ratio|0.98|||>|0.84|TWO_SIDED|95.0|0.83|1.16|||z|||We conducted a generalized estimating equations analysis (negative binomial distribution, log link) to test whether number of adverse events reported increased from baseline to the follow-ups differentially across placebo and XR-NTX groups||1.16|.83|>.84
71929048|NCT00448630|143379737|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
71929049|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.490
71929050|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929051|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.006
71929052|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929053|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.003
71929054|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929055|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.050
71929056|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0012||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0012
71929057|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0078
71929058|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
71929059|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0133
71929060|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0142||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0142
71929061|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0265
71929062|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1613||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1613
71929063|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2644||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2644
71929064|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||5e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000005
71929065|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7385||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7385
71929066|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.0000
71929067|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6813||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6813
71929068|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
71929069|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2237||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2237
71929070|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5774
71929071|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
71929072|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2502||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2502
71929073|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5224||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5224
71929074|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0001
71929075|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
71929076|NCT00448630|143379738|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8166||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8166
71929077|NCT00448630|143379739|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.||||<0.001
71929078|NCT00448630|143379740|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
71929079|NCT00448630|143379741|SUPERIORITY_OR_OTHER_LEGACY|||||||0.544||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.544
71929080|NCT00448630|143379742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.245
71929081|NCT00448630|143379743|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.362
71929082|NCT00448630|143379744|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||0.176
71929083|NCT00448630|143379745|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time (Baseline, 1 month, 4 months).||||<0.001
71929084|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.524||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.524
71929085|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929086|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.005
71929087|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929088|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.009
71929089|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929090|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.047
71929091|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0007
71929092|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0057||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0057
71929093|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
71929094|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0201||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0201
71929095|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0095||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0095
71929096|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0386
71929097|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1976||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1976
71929098|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2383||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2383
71929099|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||2e-05||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00002
71929100|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8297||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8297
71929101|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9081||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.9081
71929102|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7386
71929103|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0024||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0024
71929104|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2587
71929105|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6263||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6263
71929106|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||1e-06||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.000001
71929107|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2589||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2589
71929108|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5153||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5153
71929109|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0003
71929110|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0005
71929111|NCT00448630|143379746|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8952||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8952
71929112|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.197||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.197
71929113|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.010
71929114|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.012
71929115|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929116|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.282||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.282
71929117|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.040
71929118|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.004
71929119|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0193
71929120|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0065||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0065
71929121|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0002
71929122|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3172||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3172
71929123|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0116||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0116
71929124|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0016||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0016
71929125|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.26||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2600
71929126|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2309||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2309
71929127|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0063||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0063
71929128|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8158||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.8158
71929129|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3968||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.3968
71929130|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7193||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.7193
71929131|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
71929132|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.2351
71929133|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5672||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5672
71929134|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.00009
71929135|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1774||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.1774
71929136|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6082||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6082
71929137|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0079
71929138|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0014
71929139|NCT00448630|143379747|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5587||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5587
71929140|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.077
71929141|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.039
71929142|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.978||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.978
71929143|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||<0.001
71929144|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.593||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.593
71929145|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.987||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.987
71929146|NCT00448630|143379748|SUPERIORITY_OR_OTHER_LEGACY|||||||0.174||95.0||||P-value was not adjusted for multiple comparisons; p-values \< 0.05 were considered statistically significant.|Friedman|||Friedman's test was used to assess trends over time.||||0.174
71929147|NCT00468312|143379749|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
71929148|NCT00468312|143379750|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.026
71929149|NCT00468312|143379751|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
71929150|NCT00468312|143379752|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||<0.001
71929151|NCT00468312|143379753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.269||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.||||||0.269
71929152|NCT01052038|143379754|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|||||||<0.001
71929153|NCT01052038|143379754|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
71929154|NCT01052038|143379754|SUPERIORITY_OR_OTHER||Median Difference (Net)|1.0|||<|0.001|TWO_SIDED|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)|||||2|0|<0.001
71929155|NCT01052038|143379755|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Kruskal-Wallis|Dunn's post hoc-test corrected for 12 comparisons.||||||<0.001
71929156|NCT01052038|143379755|SUPERIORITY_OR_OTHER||Median Difference (Net)|22.0||||0.005|TWO_SIDED|95.0|14.0|29.0|||Wilcoxon (Mann-Whitney)|||||29|14|0.005
71689794|NCT00502853|142895937|SUPERIORITY_OR_OTHER||Slope|-6.6294|STANDARD_ERROR_OF_MEAN|1.8623||0.0074|||||||Random Coefficient Model|||Trend over time||||0.0074
71929157|NCT01052038|143379755|SUPERIORITY_OR_OTHER||Median Difference (Net)|14.0||||0.004|TWO_SIDED|95.0|7.0|22.0|||Wilcoxon (Mann-Whitney)|||||22|7|0.004
71929158|NCT01052038|143379756|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared, Corrected|||||||0.004
71929159|NCT01052038|143379757|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Kruskal-Wallis|Post hoc test using Dunn's test corrected for 12 comparisons||||||0.01
71929160|NCT01052038|143379757|SUPERIORITY_OR_OTHER||Median Difference (Net)|10.0||||0.003||95.0|0.0|20.0|||Wilcoxon (Mann-Whitney)|||||20|0|0.003
71929161|NCT01052038|143379758|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared, Corrected|||||||0.04
71929162|NCT04253756|143379786|NON_INFERIORITY|The margin of non-inferiority (Delta) was 5g/dl|Mean Difference (Final Values)|0.5||||0.87|TWO_SIDED||||||ANOVA|||||||0.87
71929163|NCT04253756|143379787|NON_INFERIORITY|The non-inferiority margin (Delta) was 10 minutes of run time, no other key parameters|Mean Difference (Final Values)|3.2||||0.32|TWO_SIDED||||||ANOVA|||||||0.32
71929164|NCT00388674|143379794|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.3553|TWO_SIDED|95.03|0.8|1.084|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.084|0.800|0.3553
71929165|NCT00388674|143379795|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.85||||0.0676|TWO_SIDED|95.03|0.713|1.012|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.012|0.713|0.0676
71929166|NCT00388674|143379796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.1182|TWO_SIDED|95.03|0.769|1.03|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.030|0.769|0.1182
71929167|NCT00388674|143379797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1|||||TWO_SIDED|95.0|0.817|1.478|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.478|0.817|
71929168|NCT00388674|143379798|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.727|1.032|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.032|0.727|
71929169|NCT00388674|143379799|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91|||||TWO_SIDED|95.0|0.608|1.365|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience|||1.365|0.608|
71929170|NCT00759174|143379800|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.15||||0.033|TWO_SIDED|95.0|1.06|4.34|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.34|1.06|0.033
71929171|NCT00759174|143379801|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.36||||0.003|TWO_SIDED|95.0|1.33|4.19|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||4.19|1.33|0.003
71929172|NCT00759174|143379802|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.61|||<|0.001|TWO_SIDED|95.0|1.7|7.69|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.||7.69|1.70|<0.001
71929173|NCT00568776|143379855|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.71|TWO_SIDED|95.0|-0.14|0.21|||Mixed Models Analysis|||||0.21|-0.14|0.71
71929174|NCT00568776|143379856|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.56|STANDARD_ERROR_OF_MEAN|1.9||0.18|TWO_SIDED|95.0|-6.33|1.22|||Mixed Models Analysis|||||1.22|-6.33|0.18
71929175|NCT00568776|143379857|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.11||0.17|TWO_SIDED|95.0|-0.06|0.36|||Mixed Models Analysis|||||0.36|-0.06|0.17
71929176|NCT00568776|143379858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|2.03||0.49|TWO_SIDED|95.0|-5.41|2.62|||Mixed Models Analysis|||||2.62|-5.41|0.49
71929177|NCT00568776|143379859|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|2.2||0.77|TWO_SIDED|95.0|-3.73|5.03|||Mixed Models Analysis|||||5.03|-3.73|0.77
71929178|NCT00568776|143379860|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.47||0.54|TWO_SIDED|95.0|-0.63|1.21|||Mixed Models Analysis|||||1.21|-0.63|0.54
71929179|NCT00568776|143379861|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.02|STANDARD_ERROR_OF_MEAN|2.24||0.65|TWO_SIDED|95.0|-3.43|5.46|||Mixed Models Analysis|||||5.46|-3.43|0.65
71929180|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|6.116|||<|0.0001|TWO_SIDED|95.0|5.976|6.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||6.255|5.976|<.0001
71929181|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|6.073|||<|0.0001|TWO_SIDED|95.0|5.963|6.183|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||6.183|5.963|<.0001
71929182|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.736|||<|0.0001|TWO_SIDED|95.0|5.605|5.868|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||5.868|5.605|<.0001
71929183|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.792|||<|0.0001|TWO_SIDED|95.0|5.687|5.897|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||5.897|5.687|<.0001
71929184|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.835|||<|0.0001|TWO_SIDED|95.0|5.701|5.969|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||5.969|5.701|<.0001
71929185|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|5.799|||<|0.0001|TWO_SIDED|95.0|5.694|5.904|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||5.904|5.694|<.0001
71929186|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|4.881|||<|0.0001|TWO_SIDED|95.0|4.713|5.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||5.048|4.713|<.0001
71929187|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.844|||<|0.0001|TWO_SIDED|95.0|4.711|4.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||4.977|4.711|<.0001
71929188|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.185|||<|0.0001|TWO_SIDED|95.0|5.021|5.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||5.350|5.021|<.0001
71929189|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.933|||<|0.0001|TWO_SIDED|95.0|4.801|5.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||5.066|4.801|<.0001
71689795|NCT00502853|142895937|SUPERIORITY_OR_OTHER|||||||0.1273|||||||Student's t-test|||Change from Baseline at Week 4||||0.1273
71929190|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|5.014|||<|0.0001|TWO_SIDED|95.0|4.852|5.175|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||5.175|4.852|<.0001
71929191|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|4.892|||<|0.0001|TWO_SIDED|95.0|4.763|5.02|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||5.020|4.763|<.0001
71929192|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.379||||0.0013|TWO_SIDED|95.0|-0.646|-0.112|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.112|-0.646|0.0013
71929193|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0034|TWO_SIDED|95.0|-0.496|-0.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.065|-0.496|0.0034
71929194|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.281||||0.0354|TWO_SIDED|95.0|-0.549|-0.012|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.012|-0.549|0.0354
71929195|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.274||||0.0044|TWO_SIDED|95.0|-0.489|-0.059|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.059|-0.489|0.0044
71929196|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-1.235|||<|0.0001|TWO_SIDED|95.0|-1.539|-0.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.930|-1.539|<.0001
71929197|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.229|||<|0.0001|TWO_SIDED|95.0|-1.475|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.983|-1.475|<.0001
71929198|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.93|||<|0.0001|TWO_SIDED|95.0|-1.23|-0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)"||-0.630|-1.230|<.0001
71929199|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-1.14|||<|0.0001|TWO_SIDED|95.0|-1.383|-0.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.896|-1.383|<.0001
71929200|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.723|||<|0.0001|TWO_SIDED|95.0|0.436|1.009|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.009|0.436|<.0001
71929201|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.901|||<|0.0001|TWO_SIDED|95.0|0.667|1.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.134|0.667|<.0001
71929202|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.821|||<|0.0001|TWO_SIDED|95.0|0.533|1.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)"||1.109|0.533|<.0001
71929203|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.907|||<|0.0001|TWO_SIDED|95.0|0.675|1.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)"||1.140|.675|<.0001
71929204|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|-0.133||||0.8291|TWO_SIDED|95.0|-0.453|0.188|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.188|-0.453|.8291
71929205|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.048||||0.9997|TWO_SIDED|95.0|-0.308|0.213|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.213|-0.308|0.9997
71929206|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"|Mean Difference (Net)|0.172||||0.5755|TWO_SIDED|95.0|-0.145|0.488|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)"||0.488|-0.145|0.5755
71929207|NCT03692078|143379862|EQUIVALENCE|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"|Mean Difference (Net)|0.042||||0.9999|TWO_SIDED|95.0|-0.217|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7.~Alternate hypothesis: NNAL amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)"||0.301|-0.217|0.9999
71929208|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.629|||<|0.0001|TWO_SIDED|95.0|2.317|2.94|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)"||2.940|2.317|<.0001
71929209|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.632|||<|0.0001|TWO_SIDED|95.0|2.321|2.943|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)"||2.943|2.321|<.0001
71929210|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|2.006|||<|0.0001|TWO_SIDED|95.0|1.714|2.298|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)"||2.298|1.714|<.0001
71929211|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.143|||<|0.0001|TWO_SIDED|95.0|1.847|2.44|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)"||2.440|1.847|<.0001
71929212|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|1.987|||<|0.0001|TWO_SIDED|95.0|1.69|2.284|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)"||2.284|1.690|<.0001
71929213|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|2.261|||<|0.0001|TWO_SIDED|95.0|1.964|2.559|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)"||2.559|1.964|<.0001
71929214|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.263||||0.1658|TWO_SIDED|95.0|-0.635|0.109|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)"||0.109|-0.635|0.1658
71929215|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.659||||0.0007|TWO_SIDED|95.0|-1.036|-0.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)"||-0.282|-1.036|0.0007
71929216|NCT03692078|143379864|NON_INFERIORITY|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.302||||0.1055|TWO_SIDED|95.0|-0.667|0.064|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)"||0.064|-0.667|0.1055
71929217|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.243||||0.204|TWO_SIDED|95.0|-0.617|0.132|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)"||0.132|-0.617|0.2040
71929218|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"|Mean Difference (Net)|-0.244||||0.1829|TWO_SIDED|95.0|-0.603|0.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)"||0.116|-0.603|0.1829
71929219|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"|Mean Difference (Net)|-0.248||||0.1801|TWO_SIDED|95.0|-0.612|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)"||0.115|-0.612|0.1801
71929220|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.622||||0.0391|TWO_SIDED|95.0|-1.225|-0.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.019|-1.225|0.0391
71929221|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.1864|TWO_SIDED|95.0|-1.096|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.119|-1.096|0.1864
71929222|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.037|-1.246|0.0310
71929223|NCT03692078|143379864|EQUIVALENCE|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"|Mean Difference (Net)|-0.642||||0.031|TWO_SIDED|95.0|-1.246|-0.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|"Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7.~Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)"||-0.037|-1.246|0.0310
71929224|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.891|||<|0.0001|TWO_SIDED|95.0|-3.58|-2.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.202|-3.580|<.0001
71929225|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.291|||<|0.0001|TWO_SIDED|95.0|-3.985|-2.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.597|-3.985|<.0001
71929226|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.93|||<|0.0001|TWO_SIDED|95.0|-3.605|-2.255|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.255|-3.605|<.0001
71929227|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.875|||<|0.0001|TWO_SIDED|95.0|-3.559|-2.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.190|-3.559|<.0001
71929228|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|1.604|2.896|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.896|1.604|<.0001
71929229|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.391|||<|0.0001|TWO_SIDED|95.0|1.737|3.046|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||3.046|1.737|<.0001
71929230|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.231|||<|0.0001|TWO_SIDED|95.0|1.582|2.879|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.879|1.582|<.0001
71929231|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.509|||<|0.0001|TWO_SIDED|95.0|1.857|3.162|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.162|1.857|<.0001
71929232|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.019||||1|TWO_SIDED|95.0|-0.743|0.705|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.705|-0.743|1.0000
71929233|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.411||||0.5639|TWO_SIDED|95.0|-1.142|0.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.320|-1.142|0.5639
71929234|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||1|TWO_SIDED|95.0|-0.771|0.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.656|-0.771|1.0000
71929235|NCT03692078|143379864|EQUIVALENCE|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.006||||1|TWO_SIDED|95.0|-0.721|0.732|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: NNN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.732|-0.721|1.0000
71689796|NCT00502853|142895937|SUPERIORITY_OR_OTHER|||||||0.0132|||||||Student's t-test|||Change from Baseline at Week 12||||0.0132
71929236|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.691|||<|0.0001|TWO_SIDED|95.0|2.519|2.863|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.863|2.519|<.0001
71929237|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.718|||<|0.0001|TWO_SIDED|95.0|2.546|2.89|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.890|2.546|<.0001
71929238|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.415|||<|0.0001|TWO_SIDED|95.0|2.252|2.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.577|2.252|<.0001
71929239|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.44|||<|0.0001|TWO_SIDED|95.0|2.276|2.603|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.603|2.276|<.0001
71929240|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.583|||<|0.0001|TWO_SIDED|95.0|2.417|2.748|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.748|2.417|<.0001
71929241|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.591|||<|0.0001|TWO_SIDED|95.0|2.426|2.757|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.757|2.426|<.0001
71929242|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.107|||<|0.0001|TWO_SIDED|95.0|0.901|1.314|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.314|0.901|<.0001
71929243|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.017|||<|0.0001|TWO_SIDED|95.0|0.81|1.225|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.225|0.810|<.0001
71929244|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.828|||<|0.0001|TWO_SIDED|95.0|1.624|2.031|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.031|1.624|<.0001
71929245|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.782|||<|0.0001|TWO_SIDED|95.0|1.577|1.988|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.988|1.577|<.0001
71929246|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.55|||<|0.0001|TWO_SIDED|95.0|-0.75|-0.35|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.350|-0.750|<.0001
71929247|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.85|||<|0.0001|TWO_SIDED|95.0|-1.051|-0.65|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.650|-1.051|<.0001
71929248|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.276||||0.1608|TWO_SIDED|95.0|-0.609|0.057|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.057|-0.609|0.1608
71929249|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.278||||0.1575|TWO_SIDED|95.0|-0.613|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.056|-0.613|0.1575
71929250|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.108||||0.9728|TWO_SIDED|95.0|-0.442|0.226|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.226|-0.442|0.9728
71929251|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.127||||0.9262|TWO_SIDED|95.0|-0.461|0.208|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.208|-0.461|0.9262
71929252|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.584|||<|0.0001|TWO_SIDED|95.0|-1.963|-1.204|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.204|-1.963|<.0001
71929253|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.701|||<|0.0001|TWO_SIDED|95.0|-2.081|-1.32|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.320|-2.081|<.0001
71689797|NCT00502853|142895937|SUPERIORITY_OR_OTHER|||||||0.1542|||||||Student's t-test|||Change from Baseline at Week 24||||0.1542
71929254|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.863|||<|0.0001|TWO_SIDED|95.0|-1.237|-0.489|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.489|-1.237|<.0001
71929255|NCT03692078|143379866|EQUIVALENCE|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.312|-0.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: NE amount excreted (mg/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: NE amount excreted (mg/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.560|-1.312|<.0001
71929256|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.47|||<|0.0001|TWO_SIDED|95.0|3.31|3.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.630|3.310|<.0001
71929257|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.508|||<|0.0001|TWO_SIDED|95.0|3.348|3.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.668|3.348|<.0001
71929258|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.891|||<|0.0001|TWO_SIDED|95.0|2.741|3.042|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.042|2.741|<.0001
71929259|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.873|||<|0.0001|TWO_SIDED|95.0|2.719|3.027|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.027|2.719|<.0001
71929260|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.928|||<|0.0001|TWO_SIDED|95.0|2.775|3.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.082|2.775|<.0001
71929261|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.896|||<|0.0001|TWO_SIDED|95.0|2.742|3.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.049|2.742|<.0001
71929262|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.864|||<|0.0001|TWO_SIDED|95.0|0.672|1.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.055|0.672|<.0001
71689798|NCT00502853|142895938|SUPERIORITY_OR_OTHER|||||||0.1396|||||||Student's t-test|||Change from Baseline at Week 4||||0.1396
71929263|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.786|||<|0.0001|TWO_SIDED|95.0|0.592|0.981|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.981|0.592|<.0001
71929264|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.641|||<|0.0001|TWO_SIDED|95.0|0.452|0.829|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.829|0.452|<.0001
71929265|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.485|||<|0.0001|TWO_SIDED|95.0|0.29|0.68|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.680|0.290|<.0001
71929266|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.747|||<|0.0001|TWO_SIDED|95.0|0.562|0.932|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.932|0.562|<.0001
71929267|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.833|||<|0.0001|TWO_SIDED|95.0|0.645|1.021|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.021|0.645|<.0001
71929268|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.579|||<|0.0001|TWO_SIDED|95.0|-0.889|-0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.268|-0.889|<.0001
71929269|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.635|||<|0.0001|TWO_SIDED|95.0|-0.949|-0.321|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.321|-0.949|<.0001
71929270|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.542|||<|0.0001|TWO_SIDED|95.0|-0.853|-0.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.231|-0.853|<.0001
71689799|NCT00502853|142895938|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 12||||0.0050
71689800|NCT00502853|142895938|SUPERIORITY_OR_OTHER|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 24||||0.0050
71689801|NCT00502853|142895938|SUPERIORITY_OR_OTHER||Slope|-0.2902|STANDARD_ERROR_OF_MEAN|0.07966||0.0054|||||||Random coefficient model|||Trend over time||||0.0054
71689802|NCT00502853|142895939|SUPERIORITY_OR_OTHER|||||||0.0254|||||||Student's t-test|||Change from Baseline at Week 4||||0.0254
71929271|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.924|-0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.301|-0.924|<.0001
71929272|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.606|||<|0.0001|TWO_SIDED|95.0|-2.959|-2.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.253|-2.959|<.0001
71929273|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.722|||<|0.0001|TWO_SIDED|95.0|-3.078|-2.366|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.366|-3.078|<.0001
71929274|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.829|||<|0.0001|TWO_SIDED|95.0|-3.177|-2.481|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.481|-3.177|<.0001
71929275|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.024|||<|0.0001|TWO_SIDED|95.0|-3.378|-2.669|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.669|-3.378|<.0001
71929276|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.144|||<|0.0001|TWO_SIDED|95.0|1.811|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.811|<.0001
71929277|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.04|||<|0.0001|TWO_SIDED|95.0|1.701|2.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.379|1.701|<.0001
71929278|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.181|||<|0.0001|TWO_SIDED|95.0|1.846|2.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.516|1.846|<.0001
71929279|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.063|||<|0.0001|TWO_SIDED|95.0|1.725|2.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.400|1.725|<.0001
71929280|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.117||||0.9705|TWO_SIDED|95.0|-0.256|0.49|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.490|-0.256|0.9705
71929281|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.047||||1|TWO_SIDED|95.0|-0.425|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.332|-0.425|1.0000
71929282|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.106||||0.9835|TWO_SIDED|95.0|-0.475|0.263|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.263|-0.475|0.9835
71929283|NCT03692078|143379868|EQUIVALENCE|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.348||||0.0854|TWO_SIDED|95.0|-0.725|0.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-AN amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.029|-0.725|0.0854
71929284|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.028|||<|0.0001|TWO_SIDED|95.0|2.901|3.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.154|2.901|<.0001
71929285|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.034|||<|0.0001|TWO_SIDED|95.0|2.927|3.141|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.141|2.927|<.0001
71929286|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.603|||<|0.0001|TWO_SIDED|95.0|2.483|2.722|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.722|2.483|<.0001
71929287|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.567|||<|0.0001|TWO_SIDED|95.0|2.465|2.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.670|2.465|<.0001
71929288|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.716|||<|0.0001|TWO_SIDED|95.0|2.595|2.838|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.838|2.595|<.0001
71929289|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.643|||<|0.0001|TWO_SIDED|95.0|2.541|2.746|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.746|2.541|<.0001
71929290|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.235|||<|0.0001|TWO_SIDED|95.0|1.083|1.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.386|1.083|<.0001
71929291|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.045|1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.304|1.045|<.0001
71929292|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.219|||<|0.0001|TWO_SIDED|95.0|1.07|1.368|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.368|1.070|<.0001
71929293|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.046|1.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.306|1.046|<.0001
71929294|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.176|||<|0.0001|TWO_SIDED|95.0|1.029|1.322|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.322|1.029|<.0001
71929295|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.174|||<|0.0001|TWO_SIDED|95.0|1.049|1.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.300|1.049|<.0001
71929296|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.425|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.181|-0.669|<.0001
71929297|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.467|||<|0.0001|TWO_SIDED|95.0|-0.677|-0.256|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.256|-0.677|<.0001
71929298|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.311||||0.0052|TWO_SIDED|95.0|-0.556|-0.066|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.066|-0.556|0.0052
71929299|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.391|||<|0.0001|TWO_SIDED|95.0|-0.6|-0.182|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.182|-0.600|<.0001
71929300|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.793|||<|0.0001|TWO_SIDED|95.0|-2.07|-1.516|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.516|-2.070|<.0001
71929301|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.859|||<|0.0001|TWO_SIDED|95.0|-2.098|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.098|<.0001
71929302|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.809|||<|0.0001|TWO_SIDED|95.0|-2.082|-1.535|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.535|-2.082|<.0001
71929303|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.858|||<|0.0001|TWO_SIDED|95.0|-2.096|-1.621|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.621|-2.096|<.0001
71929304|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.427|||<|0.0001|TWO_SIDED|95.0|1.166|1.688|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.688|1.166|<.0001
71929305|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.393|||<|0.0001|TWO_SIDED|95.0|1.166|1.62|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.620|1.166|<.0001
71689803|NCT00502853|142895939|SUPERIORITY_OR_OTHER|||||||0.0384|||||||Student's t-test|||Change from Baseline at Week 12||||0.0384
71929306|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.541|||<|0.0001|TWO_SIDED|95.0|1.278|1.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.803|1.278|<.0001
71929307|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.243|1.695|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.695|1.243|<.0001
71929308|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.059||||0.9987|TWO_SIDED|95.0|-0.233|0.351|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.351|-0.233|0.9987
71929309|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.0||||1|TWO_SIDED|95.0|-0.253|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.253|1.0000
71929310|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||0.9999|TWO_SIDED|95.0|-0.246|0.332|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.332|-0.246|0.9999
71929311|NCT03692078|143379870|EQUIVALENCE|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.002||||1|TWO_SIDED|95.0|-0.251|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 4-ABP amount excreted (ng/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.254|-0.251|1.0000
71929312|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.407|||<|0.0001|TWO_SIDED|95.0|2.283|2.531|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||2.531|2.283|<.0001
71929313|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.398|||<|0.0001|TWO_SIDED|95.0|2.253|2.543|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||2.543|2.253|<.0001
71929314|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.303|||<|0.0001|TWO_SIDED|95.0|2.187|2.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.420|2.187|<.0001
71689804|NCT00502853|142895939|SUPERIORITY_OR_OTHER|||||||0.0271|||||||Student's t-test|||Change from Baseline at Week 24||||0.0271
71929315|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.25|||<|0.0001|TWO_SIDED|95.0|2.112|2.389|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.389|2.112|<.0001
71929316|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.285|||<|0.0001|TWO_SIDED|95.0|2.166|2.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.404|2.166|<.0001
71929317|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.272|||<|0.0001|TWO_SIDED|95.0|2.133|2.412|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.412|2.133|<.0001
71929318|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.992|||<|0.0001|TWO_SIDED|95.0|1.844|2.14|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.140|1.844|<.0001
71929319|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.894|||<|0.0001|TWO_SIDED|95.0|1.719|2.069|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.069|1.719|<.0001
71929320|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.102|||<|0.0001|TWO_SIDED|95.0|1.955|2.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.248|1.955|<.0001
71929321|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.075|||<|0.0001|TWO_SIDED|95.0|1.9|2.25|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.250|1.900|<.0001
71929322|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.89|||<|0.0001|TWO_SIDED|95.0|1.746|2.033|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.033|1.746|<.0001
71929323|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.944|||<|0.0001|TWO_SIDED|95.0|1.775|2.114|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.114|1.775|<.0001
71689805|NCT00502853|142895939|SUPERIORITY_OR_OTHER||Slope|-4.7586|STANDARD_ERROR_OF_MEAN|1.5278||0.0124|||||||Random coefficient model|||Trend over time||||0.0124
71929324|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.8674|TWO_SIDED|95.0|-0.345|0.137|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.137|-0.345|0.8674
71929325|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.148||||0.6519|TWO_SIDED|95.0|-0.429|0.133|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.133|-0.429|0.6519
71929326|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.122||||0.7301|TWO_SIDED|95.0|-0.363|0.119|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.119|-0.363|0.7301
71929327|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.126||||0.8076|TWO_SIDED|95.0|-0.405|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.154|-0.405|0.8076
71929328|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.415||||0.0004|TWO_SIDED|95.0|-0.689|-0.142|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.142|-0.689|0.0004
71929329|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.504||||0.0002|TWO_SIDED|95.0|-0.822|-0.185|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.185|-0.822|0.0002
71929330|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.306||||0.0183|TWO_SIDED|95.0|-0.578|-0.034|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.034|-0.578|0.0183
71929331|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.323||||0.0443|TWO_SIDED|95.0|-0.641|-0.005|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.005|-0.641|0.0443
71689806|NCT00502853|142895940|SUPERIORITY_OR_OTHER|||||||0.7376|||||||Student's t-test|||Change from Baseline at Week 4||||0.7376
71929332|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.414||||0.0002|TWO_SIDED|95.0|0.155|0.672|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.672|0.155|0.0002
71689807|NCT00502853|142895940|SUPERIORITY_OR_OTHER|||||||0.1631|||||||Student's t-test|||Change from Baseline at Week 12||||0.1631
71929333|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.306||||0.0454|TWO_SIDED|95.0|0.004|0.608|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.608|0.004|0.0454
71929334|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.396||||0.0004|TWO_SIDED|95.0|0.136|0.655|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.655|0.136|0.0004
71929335|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.328||||0.0261|TWO_SIDED|95.0|0.026|0.63|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.630|0.026|0.0261
71929336|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.102||||0.9455|TWO_SIDED|95.0|-0.187|0.392|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.392|-0.187|0.9455
71929337|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.9999|TWO_SIDED|95.0|-0.387|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.287|-0.387|0.9999
71929338|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.212||||0.2633|TWO_SIDED|95.0|-0.074|0.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.498|-0.074|0.2633
71689808|NCT00502853|142895940|SUPERIORITY_OR_OTHER|||||||0.8816|||||||Student's t-test|||Change from Baseline at Week 24||||0.8816
71689809|NCT00502853|142895940|SUPERIORITY_OR_OTHER||Slope|-0.2927|STANDARD_ERROR_OF_MEAN|1.9408||0.8835|||||||Random coefficient model|||Trend over time||||0.8835
71689810|NCT00502853|142895941|SUPERIORITY_OR_OTHER|||||||0.1312|||||||Student's t-test|||Change from Baseline at Week 4||||0.1312
71929339|NCT03692078|143379872|EQUIVALENCE|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.13||||0.8769|TWO_SIDED|95.0|-0.205|0.465|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: HEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.465|-0.205|0.8769
71929340|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|5.417|||<|0.0001|TWO_SIDED|95.0|5.315|5.52|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (PP Population)||5.520|5.315|<.0001
71929341|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|5.436|||<|0.0001|TWO_SIDED|95.0|5.324|5.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (PP Population)||5.548|5.324|<.0001
71929342|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.957|||<|0.0001|TWO_SIDED|95.0|4.86|5.053|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (PP Population)||5.053|4.860|<.0001
71929343|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.974|||<|0.0001|TWO_SIDED|95.0|4.867|5.081|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (PP Population)||5.081|4.867|<.0001
71929344|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|4.984|||<|0.0001|TWO_SIDED|95.0|4.886|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (PP Population)||5.082|4.886|<.0001
71929345|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|4.975|||<|0.0001|TWO_SIDED|95.0|4.868|5.082|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (PP Population)||5.082|4.868|<.0001
71929346|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.49|||<|0.0001|TWO_SIDED|95.0|3.367|3.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (PP Population)||3.612|3.367|<.0001
71929347|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.347|||<|0.0001|TWO_SIDED|95.0|3.212|3.483|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (PP Population)||3.483|3.212|<.0001
71929348|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.539|||<|0.0001|TWO_SIDED|95.0|3.418|3.66|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (PP Population)||3.660|3.418|<.0001
71929349|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.419|||<|0.0001|TWO_SIDED|95.0|3.284|3.554|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (PP Population)||3.554|3.284|<.0001
71929350|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)|Mean Difference (Net)|3.492|||<|0.0001|TWO_SIDED|95.0|3.373|3.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (PP Population)||3.611|3.373|<.0001
71929351|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)|Mean Difference (Net)|3.437|||<|0.0001|TWO_SIDED|95.0|3.306|3.568|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (PP Population)||3.568|3.306|<.0001
71929352|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.66|-0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (PP Population)||-0.262|-0.660|<.0001
71929353|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.462|||<|0.0001|TWO_SIDED|95.0|-0.679|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.679|<.0001
71929354|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-0.433|||<|0.0001|TWO_SIDED|95.0|-0.633|-0.233|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (PP Population)||-0.233|-0.633|<.0001
71929355|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-0.461|||<|0.0001|TWO_SIDED|95.0|-0.678|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (PP Population)||-0.244|-0.678|<.0001
71929356|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.928|||<|0.0001|TWO_SIDED|95.0|-2.154|-1.701|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (PP Population)||-1.701|-2.154|<.0001
71929357|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.089|||<|0.0001|TWO_SIDED|95.0|-2.336|-1.842|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (PP Population)||-1.842|-2.336|<.0001
71929358|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)|Mean Difference (Net)|-1.879|||<|0.0001|TWO_SIDED|95.0|-2.102|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (PP Population)||-1.656|-2.102|<.0001
71929359|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)|Mean Difference (Net)|-2.017|||<|0.0001|TWO_SIDED|95.0|-2.262|-1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (PP Population)||-1.772|-2.262|<.0001
71929360|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.465|||<|0.0001|TWO_SIDED|95.0|1.25|1.679|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (PP Population)||1.679|1.250|<.0001
71929361|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.537|||<|0.0001|TWO_SIDED|95.0|1.303|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.303|<.0001
71929362|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|1.492|||<|0.0001|TWO_SIDED|95.0|1.277|1.707|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (PP Population)||1.707|1.277|<.0001
71929363|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|1.538|||<|0.0001|TWO_SIDED|95.0|1.304|1.772|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (PP Population)||1.772|1.304|<.0001
71929364|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|-0.003||||1|TWO_SIDED|95.0|-0.242|0.237|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (PP Population)||0.237|-0.242|1.0000
71929365|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.09||||0.9399|TWO_SIDED|95.0|-0.351|0.172|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (PP Population)||0.172|-0.351|0.9399
71929366|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)|Mean Difference (Net)|0.047||||0.9993|TWO_SIDED|95.0|-0.19|0.283|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (PP Population)||0.283|-0.190|0.9993
71929367|NCT03692078|143379874|EQUIVALENCE|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)|Mean Difference (Net)|-0.018||||1|TWO_SIDED|95.0|-0.278|0.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: CEMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (PP Population)||0.242|-0.278|1.0000
71929368|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.805|||<|0.0001|TWO_SIDED|95.0|1.639|1.971|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.971|1.639|<.0001
71929369|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.788|||<|0.0001|TWO_SIDED|95.0|1.622|1.954|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.954|1.622|<.0001
71929370|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.29|||<|0.0001|TWO_SIDED|95.0|1.145|1.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.462|1.145|<.0001
71929371|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.304|||<|0.0001|TWO_SIDED|95.0|1.134|1.447|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.447|1.134|<.0001
71929372|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.353|||<|0.0001|TWO_SIDED|95.0|1.194|1.513|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.513|1.194|<.0001
71929373|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.313|||<|0.0001|TWO_SIDED|95.0|1.153|1.472|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.472|1.153|<.0001
71689811|NCT00502853|142895941|SUPERIORITY_OR_OTHER|||||||0.0662|||||||Student's t-test|||Change from Baseline at Week 12||||0.0662
71929374|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.956|||<|0.0001|TWO_SIDED|95.0|-1.155|-0.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-0.756|-1.155|<.0001
71929375|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.114|||<|0.0001|TWO_SIDED|95.0|-1.315|-0.913|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-0.913|-1.315|<.0001
71929376|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.999|||<|0.0001|TWO_SIDED|95.0|-1.195|-0.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-0.803|-1.195|<.0001
71929377|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.164|||<|0.0001|TWO_SIDED|95.0|-1.364|-0.964|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-0.964|-1.364|<.0001
71929378|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.775|||<|0.0001|TWO_SIDED|95.0|-0.969|-0.582|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-0.582|-0.969|<.0001
71929379|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.795|||<|0.0001|TWO_SIDED|95.0|-0.99|-0.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.600|-0.990|<.0001
71929380|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.514||||0.0002|TWO_SIDED|95.0|-0.836|-0.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.193|-0.836|0.0002
71929381|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.484||||0.0005|TWO_SIDED|95.0|-0.808|-0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.160|-0.808|0.0005
71929382|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.452||||0.0014|TWO_SIDED|95.0|-0.775|-0.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.128|-0.775|0.0014
71929383|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.475||||0.0007|TWO_SIDED|95.0|-0.799|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.799|0.0007
71929384|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.127|-2.394|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.394|-3.127|<.0001
71929385|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.902|||<|0.0001|TWO_SIDED|95.0|-3.271|-2.533|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.533|-3.271|<.0001
71929386|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.804|||<|0.0001|TWO_SIDED|95.0|-3.165|-2.443|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.443|-3.165|<.0001
71929387|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.952|||<|0.0001|TWO_SIDED|95.0|-3.317|-2.587|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.587|-3.317|<.0001
71929388|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.066|||<|0.0001|TWO_SIDED|95.0|1.719|2.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.413|1.719|<.0001
71929389|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.099|||<|0.0001|TWO_SIDED|95.0|1.748|2.449|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.449|1.748|<.0001
71689812|NCT00502853|142895941|SUPERIORITY_OR_OTHER|||||||0.4133|||||||Student's t-test|||Change from Baseline at Week 24||||0.4133
71929390|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.129|||<|0.0001|TWO_SIDED|95.0|1.779|2.478|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.478|1.779|<.0001
71929391|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.107|||<|0.0001|TWO_SIDED|95.0|1.756|2.459|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||2.459|1.756|<.0001
71929392|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.18||||0.7678|TWO_SIDED|95.0|-0.569|0.209|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.209|-0.569|0.7678
71929393|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.319||||0.1691|TWO_SIDED|95.0|-0.711|0.073|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.073|-0.711|0.1691
71929394|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5178|TWO_SIDED|95.0|-0.606|0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.158|-0.606|0.5178
71929395|NCT03692078|143379876|EQUIVALENCE|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.369||||0.0699|TWO_SIDED|95.0|-0.757|0.018|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: S-PMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.018|-0.757|0.0699
71929396|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.177|||<|0.0001|TWO_SIDED|95.0|6.062|6.292|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||6.292|6.062|<.0001
71689813|NCT00502853|142895941|SUPERIORITY_OR_OTHER||Slope|8.8196|STANDARD_ERROR_OF_MEAN|16.4534||0.6049|||||||Random coefficient model|||Trend over time||||0.6049
71929397|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.197|||<|0.0001|TWO_SIDED|95.0|6.082|6.312|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||6.312|6.082|<.0001
71929398|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.798|||<|0.0001|TWO_SIDED|95.0|5.69|5.906|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.906|5.690|<.0001
71929399|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.82|||<|0.0001|TWO_SIDED|95.0|5.71|5.93|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.930|5.710|<.0001
71929400|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.863|||<|0.0001|TWO_SIDED|95.0|5.753|5.974|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.974|5.753|<.0001
71929401|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.816|||<|0.0001|TWO_SIDED|95.0|5.706|5.927|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.927|5.706|<.0001
71929402|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.947|||<|0.0001|TWO_SIDED|95.0|4.809|5.084|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||5.084|4.809|<.0001
71929403|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.913|||<|0.0001|TWO_SIDED|95.0|4.774|5.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.052|4.774|<.0001
71929404|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.862|||<|0.0001|TWO_SIDED|95.0|4.727|4.998|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.998|4.727|<.0001
71929405|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.938|||<|0.0001|TWO_SIDED|95.0|4.799|5.076|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||5.076|4.799|<.0001
71929406|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.826|||<|0.0001|TWO_SIDED|95.0|4.693|4.959|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.959|4.693|<.0001
71929407|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.902|||<|0.0001|TWO_SIDED|95.0|4.767|5.037|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||5.037|4.767|<.0001
71929408|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.379|||<|0.0001|TWO_SIDED|95.0|-0.602|-0.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.156|-0.602|<.0001
71929409|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.376|||<|0.0001|TWO_SIDED|95.0|-0.601|-0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.152|-0.601|<.0001
71929410|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.314||||0.0014|TWO_SIDED|95.0|-0.537|-0.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.090|-0.537|0.0014
71929411|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.381|||<|0.0001|TWO_SIDED|95.0|-0.604|-0.157|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.157|-0.604|<.0001
71929412|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.484|-0.977|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.977|-1.484|<.0001
71929413|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.284|||<|0.0001|TWO_SIDED|95.0|-1.539|-1.029|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.029|-1.539|<.0001
71929414|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.564|-1.065|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.065|-1.564|<.0001
71929415|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.259|||<|0.0001|TWO_SIDED|95.0|-1.512|-1.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.006|-1.512|<.0001
71929416|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.972|||<|0.0001|TWO_SIDED|95.0|0.732|1.211|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.211|0.732|<.0001
71929417|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.918|||<|0.0001|TWO_SIDED|95.0|0.676|1.161|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.161|0.676|<.0001
71929418|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.037|||<|0.0001|TWO_SIDED|95.0|0.797|1.278|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.278|0.797|<.0001
71929419|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.914|||<|0.0001|TWO_SIDED|95.0|0.672|1.156|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.156|0.672|<.0001
71929420|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.121||||0.7939|TWO_SIDED|95.0|-0.147|0.388|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.388|-0.147|0.7939
71929421|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.26|0.281|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.281|-0.260|1.0000
71929422|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.228|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.301|-0.228|1.0000
71929423|NCT03692078|143379878|EQUIVALENCE|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.036||||1|TWO_SIDED|95.0|-0.233|0.305|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HMPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.305|-0.233|1.0000
71929424|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|7.367|||<|0.0001|TWO_SIDED|95.0|7.25|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||7.485|7.250|<.0001
71929425|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|7.368|||<|0.0001|TWO_SIDED|95.0|7.251|7.485|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||7.485|7.251|<.0001
71929426|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.883|||<|0.0001|TWO_SIDED|95.0|6.773|6.994|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||6.994|6.773|<.0001
71929427|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.892|||<|0.0001|TWO_SIDED|95.0|6.78|7.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||7.004|6.780|<.0001
71929428|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.942|||<|0.0001|TWO_SIDED|95.0|6.829|7.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||7.054|6.829|<.0001
71929429|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.896|||<|0.0001|TWO_SIDED|95.0|6.784|7.008|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||7.008|6.784|<.0001
71929430|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.879|||<|0.0001|TWO_SIDED|95.0|5.739|6.019|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||6.019|5.739|<.0001
71929431|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.804|||<|0.0001|TWO_SIDED|95.0|5.662|5.946|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||5.946|5.662|<.0001
71929432|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.916|||<|0.0001|TWO_SIDED|95.0|5.778|6.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||6.054|5.778|<.0001
71929433|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.917|||<|0.0001|TWO_SIDED|95.0|5.775|6.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||6.058|5.775|<.0001
71929434|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|6.017|||<|0.0001|TWO_SIDED|95.0|5.881|6.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||6.153|5.881|<.0001
71929435|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|6.012|||<|0.0001|TWO_SIDED|95.0|5.874|6.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||6.149|5.874|<.0001
71929436|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.484|||<|0.0001|TWO_SIDED|95.0|-0.711|-0.257|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.257|-0.711|<.0001
71929437|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.476|||<|0.0001|TWO_SIDED|95.0|-0.705|-0.248|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.248|-0.705|<.0001
71689814|NCT00502853|142895942|SUPERIORITY_OR_OTHER|||||||0.1725|||||||Student's t-test|||Change from Baseline at Week 4||||0.1725
71929438|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.426|||<|0.0001|TWO_SIDED|95.0|-0.654|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.198|-0.654|<.0001
71929439|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.472|||<|0.0001|TWO_SIDED|95.0|-0.701|-0.244|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.244|-0.701|<.0001
71929440|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.489|||<|0.0001|TWO_SIDED|95.0|-1.747|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.747|<.0001
71929441|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Final Values)|-1.564|||<|0.0001|TWO_SIDED|95.0|-1.825|-1.304|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.304|-1.825|<.0001
71929442|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.451|||<|0.0001|TWO_SIDED|95.0|-1.706|-1.197|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.197|-1.706|<.0001
71929443|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.71|-1.193|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.193|-1.710|<.0001
71929444|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.866|||<|0.0001|TWO_SIDED|95.0|0.622|1.11|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.110|0.622|<.0001
71929445|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.88|||<|0.0001|TWO_SIDED|95.0|0.633|1.128|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.128|0.633|<.0001
71929446|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.924|||<|0.0001|TWO_SIDED|95.0|0.68|1.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.169|0.680|<.0001
71929447|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.884|||<|0.0001|TWO_SIDED|95.0|0.638|1.131|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.131|0.638|<.0001
71929448|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.138||||0.68|TWO_SIDED|95.0|-0.411|0.134|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.134|-0.411|0.6800
71929449|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.208||||0.2371|TWO_SIDED|95.0|-0.483|0.068|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.068|-0.483|0.2371
71929450|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9133|TWO_SIDED|95.0|-0.371|0.169|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.169|-0.371|0.9133
71929451|NCT03692078|143379880|EQUIVALENCE|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.095||||0.9432|TWO_SIDED|95.0|-0.37|0.18|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 3-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.180|-0.370|0.9432
71929452|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.513|||<|0.0001|TWO_SIDED|95.0|4.383|4.643|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||4.643|4.383|<.0001
71929453|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.491|||<|0.0001|TWO_SIDED|95.0|4.371|4.61|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||4.610|4.371|<.0001
71929454|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.15|||<|0.0001|TWO_SIDED|95.0|4.027|4.272|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||4.272|4.027|<.0001
71689815|NCT00502853|142895942|SUPERIORITY_OR_OTHER|||||||0.0832|||||||Student's t-test|||Change from Baseline at Week 12||||0.0832
71929455|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.128|||<|0.0001|TWO_SIDED|95.0|4.014|4.242|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||4.242|4.014|<.0001
71929456|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.176|||<|0.0001|TWO_SIDED|95.0|4.051|4.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||4.301|4.051|<.0001
71929457|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.139|||<|0.0001|TWO_SIDED|95.0|4.024|4.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||4.254|4.024|<.0001
71929458|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.997|||<|0.0001|TWO_SIDED|95.0|2.842|3.153|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||3.153|2.842|<.0001
71929459|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.994|||<|0.0001|TWO_SIDED|95.0|2.849|3.138|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||3.138|2.849|<.0001
71929460|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.317|||<|0.0001|TWO_SIDED|95.0|3.164|3.47|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||3.470|3.164|<.0001
71929461|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.342|||<|0.0001|TWO_SIDED|95.0|3.199|3.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||3.486|3.199|<.0001
71929462|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.036|||<|0.0001|TWO_SIDED|95.0|2.886|3.187|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||3.187|2.886|<.0001
71689816|NCT00502853|142895942|SUPERIORITY_OR_OTHER|||||||0.1685|||||||Student's t-test|||Change from Baseline at Week 24||||0.1685
71689817|NCT00502853|142895942|SUPERIORITY_OR_OTHER||Slope|-55.4458|STANDARD_ERROR_OF_MEAN|33.5821||0.1331|||||||Random coefficient model|||Trend over time||||0.1331
71689818|NCT00502853|142895943|SUPERIORITY_OR_OTHER|||||||0.2938|||||||Student's t-test|||Change from Baseline at Week 4||||0.2938
71929463|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.159|||<|0.0001|TWO_SIDED|95.0|3.019|3.299|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||3.299|3.019|<.0001
71929464|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.363||||0.0008|TWO_SIDED|95.0|-0.613|-0.113|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.113|-0.613|0.0008
71929465|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.362||||0.0003|TWO_SIDED|95.0|-0.595|-0.129|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.129|-0.595|0.0003
71929466|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.337||||0.0026|TWO_SIDED|95.0|-0.588|-0.085|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.085|-0.588|0.0026
71929467|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.351||||0.0004|TWO_SIDED|95.0|-0.584|-0.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.118|-0.584|0.0004
71929468|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.515|||<|0.0001|TWO_SIDED|95.0|-1.8|-1.23|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.230|-1.800|<.0001
71929469|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.497|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.231|-1.762|<.0001
71929470|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.477|-0.915|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.915|-1.477|<.0001
71929471|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.148|||<|0.0001|TWO_SIDED|95.0|-1.41|-0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.886|-1.410|<.0001
71929472|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.113|||<|0.0001|TWO_SIDED|95.0|0.844|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.382|0.844|<.0001
71929473|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.969|||<|0.0001|TWO_SIDED|95.0|0.717|1.221|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.221|0.717|<.0001
71929474|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.139|||<|0.0001|TWO_SIDED|95.0|0.869|1.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.410|0.869|<.0001
71929475|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.98|||<|0.0001|TWO_SIDED|95.0|0.728|1.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.231|0.728|<.0001
71929476|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.039||||1|TWO_SIDED|95.0|-0.34|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.262|-0.340|1.0000
71929477|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.166||||0.5184|TWO_SIDED|95.0|-0.447|0.115|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.115|-0.447|0.5184
71929478|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.28||||0.0743|TWO_SIDED|95.0|-0.017|0.578|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.578|-0.017|0.0743
71689819|NCT00502853|142895943|SUPERIORITY_OR_OTHER|||||||0.2216|||||||Student's t-test|||Change from Baseline at Week 12||||0.2216
71929479|NCT03692078|143379882|EQUIVALENCE|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.183||||0.3889|TWO_SIDED|95.0|-0.095|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-HPMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|-0.095|0.3889
71929480|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.264|||<|0.0001|TWO_SIDED|95.0|5.155|5.373|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||5.373|5.155|<.0001
71929481|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.204|||<|0.0001|TWO_SIDED|95.0|5.106|5.302|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||5.302|5.106|<.0001
71929482|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.005|||<|0.0001|TWO_SIDED|95.0|4.902|5.108|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||5.108|4.902|<.0001
71929483|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.958|||<|0.0001|TWO_SIDED|95.0|4.864|5.051|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||5.051|4.864|<.0001
71929484|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|5.114|||<|0.0001|TWO_SIDED|95.0|5.009|5.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||5.219|5.009|<.0001
71929485|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|5.052|||<|0.0001|TWO_SIDED|95.0|4.958|5.146|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||5.146|4.958|<.0001
71929486|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.539|||<|0.0001|TWO_SIDED|95.0|4.407|4.671|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||4.671|4.407|<.0001
71929487|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.415|||<|0.0001|TWO_SIDED|95.0|4.295|4.534|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||4.534|4.295|<.0001
71689820|NCT00502853|142895943|SUPERIORITY_OR_OTHER|||||||0.567|TWO_SIDED||||||Student's t-test|||Change from Baseline at Week 24||||0.5670
71689821|NCT00502853|142895944|SUPERIORITY_OR_OTHER|||||||0.0934|||||||Student's t-test|||Change from Baseline at Week 4||||0.0934
71929488|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.431|||<|0.0001|TWO_SIDED|95.0|4.302|4.56|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||4.560|4.302|<.0001
71929489|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.361|||<|0.0001|TWO_SIDED|95.0|4.243|4.48|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||4.480|4.243|<.0001
71929490|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|4.486|||<|0.0001|TWO_SIDED|95.0|4.359|4.612|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||4.612|4.359|<.0001
71929491|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|4.588|||<|0.0001|TWO_SIDED|95.0|4.473|4.703|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||4.703|4.473|<.0001
71929492|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.259||||0.0073|TWO_SIDED|95.0|-0.469|-0.049|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.049|-0.469|0.0073
71929493|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.246||||0.0041|TWO_SIDED|95.0|-0.438|-0.055|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.055|-0.438|0.0041
71929494|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.15||||0.308|TWO_SIDED|95.0|-0.361|0.061|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.061|-0.361|0.3080
71929495|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.152||||0.1982|TWO_SIDED|95.0|-0.343|0.039|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.039|-0.343|0.1982
71689822|NCT00502853|142895944|SUPERIORITY_OR_OTHER|||||||0.4047|||||||Student's t-test|||Change from Baseline at Week 12||||0.4047
71689823|NCT00502853|142895944|SUPERIORITY_OR_OTHER|||||||0.2101|||||||Student's t-test|||Change from Baseline at Week 24||||0.2101
71689824|NCT00502853|142895944|SUPERIORITY_OR_OTHER||Slope|0.3997|STANDARD_ERROR_OF_MEAN|0.2506||0.1451|||||||Random coefficient model|||Trend over time||||0.1451
71689825|NCT00502853|142895945|SUPERIORITY_OR_OTHER|||||||0.4963|||||||Student's t-test|||Change from Baseline at Week 4||||0.4963
71929496|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.725|||<|0.0001|TWO_SIDED|95.0|-0.965|-0.486|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.486|-0.965|<.0001
71929497|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.79|||<|0.0001|TWO_SIDED|95.0|-1.008|-0.571|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.571|-1.008|<.0001
71929498|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.833|||<|0.0001|TWO_SIDED|95.0|-1.069|-0.597|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.597|-1.069|<.0001
71929499|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.843|||<|0.0001|TWO_SIDED|95.0|-1.059|-0.627|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.627|-1.059|<.0001
71929500|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.52|||<|0.0001|TWO_SIDED|95.0|0.294|0.745|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.745|0.294|<.0001
71929501|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.37|||<|0.0001|TWO_SIDED|95.0|0.163|0.577|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.577|0.163|<.0001
71929502|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.628|||<|0.0001|TWO_SIDED|95.0|0.402|0.855|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.855|0.402|<.0001
71929503|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.464|||<|0.0001|TWO_SIDED|95.0|0.257|0.67|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.670|0.257|<.0001
71929504|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.053||||0.9984|TWO_SIDED|95.0|-0.2|0.306|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.306|-0.200|0.9984
71929505|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.173||||0.2491|TWO_SIDED|95.0|-0.405|0.058|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.058|-0.405|0.2491
71929506|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.054||||0.9977|TWO_SIDED|95.0|-0.304|0.195|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.195|-0.304|0.9977
71929507|NCT03692078|143379884|EQUIVALENCE|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.227||||0.0554|TWO_SIDED|95.0|-0.456|0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: AAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.003|-0.456|0.0554
71929508|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.294|||<|0.0001|TWO_SIDED|95.0|3.208|3.379|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.379|3.208|<.0001
71929509|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.262|||<|0.0001|TWO_SIDED|95.0|3.176|3.348|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.348|3.176|<.0001
71929510|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|3.039|3.202|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||3.202|3.039|<.0001
71929511|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.099|||<|0.0001|TWO_SIDED|95.0|3.017|3.181|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||3.181|3.017|<.0001
71929512|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.182|||<|0.0001|TWO_SIDED|95.0|3.1|3.264|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||3.264|3.100|<.0001
71929513|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.149|||<|0.0001|TWO_SIDED|95.0|3.066|3.231|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||3.231|3.066|<.0001
71929514|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.777|||<|0.0001|TWO_SIDED|95.0|2.673|2.881|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||2.881|2.673|<.0001
71929515|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.651|||<|0.0001|TWO_SIDED|95.0|2.546|2.756|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||2.756|2.546|<.0001
71929516|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.72|||<|0.0001|TWO_SIDED|95.0|2.618|2.823|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||2.823|2.618|<.0001
71929517|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.649|||<|0.0001|TWO_SIDED|95.0|2.544|2.753|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||2.753|2.544|<.0001
71929518|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.751|||<|0.0001|TWO_SIDED|95.0|2.651|2.851|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||2.851|2.651|<.0001
71929519|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.819|||<|0.0001|TWO_SIDED|95.0|2.718|2.919|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||2.919|2.718|<.0001
71929520|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.173||||0.0377|TWO_SIDED|95.0|-0.34|-0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.006|-0.340|0.0377
71929521|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.163||||0.0643|TWO_SIDED|95.0|-0.331|0.006|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.006|-0.331|0.0643
71689826|NCT00502853|142895945|SUPERIORITY_OR_OTHER|||||||0.2198|||||||Student's t-test|||Change from Baseline at Week 12||||0.2198
71929522|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.112||||0.3875|TWO_SIDED|95.0|-0.279|0.056|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.056|-0.279|0.3875
71929523|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.113||||0.3725|TWO_SIDED|95.0|-0.28|0.054|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.054|-0.280|0.3725
71929524|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.516|||<|0.0001|TWO_SIDED|95.0|-0.706|-0.327|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.327|-0.706|<.0001
71929525|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.611|||<|0.0001|TWO_SIDED|95.0|-0.802|-0.42|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.420|-0.802|<.0001
71929526|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.573|||<|0.0001|TWO_SIDED|95.0|-0.76|-0.386|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.386|-0.760|<.0001
71929527|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.613|||<|0.0001|TWO_SIDED|95.0|-0.803|-0.423|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.423|-0.803|<.0001
71929528|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.369|||<|0.0001|TWO_SIDED|95.0|0.19|0.548|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.548|0.190|<.0001
71929529|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.28||||0.0003|TWO_SIDED|95.0|0.099|0.462|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.462|0.099|0.0003
71929530|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.431|||<|0.0001|TWO_SIDED|95.0|0.251|0.611|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.611|0.251|<.0001
71929531|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.33|||<|0.0001|TWO_SIDED|95.0|0.149|0.511|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.511|0.149|<.0001
71929532|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.026||||1|TWO_SIDED|95.0|-0.176|0.228|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.228|-0.176|1.0000
71929533|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.168||||0.1589|TWO_SIDED|95.0|-0.371|0.036|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.036|-0.371|0.1589
71929534|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.031||||0.9999|TWO_SIDED|95.0|-0.23|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.168|-0.230|0.9999
71929535|NCT03692078|143379886|EQUIVALENCE|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.17||||0.1453|TWO_SIDED|95.0|-0.372|0.032|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: GAMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.032|-0.372|0.1453
71929536|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.085|||<|0.0001|TWO_SIDED|95.0|0.788|1.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.382|0.788|<.0001
71929537|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.104|||<|0.0001|TWO_SIDED|95.0|0.807|1.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.400|0.807|<.0001
71929538|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.606|||<|0.0001|TWO_SIDED|95.0|0.326|0.886|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||0.886|0.326|<.0001
71929539|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.476||||0.0011|TWO_SIDED|95.0|0.192|0.76|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||0.760|0.192|0.0011
71929540|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.505||||0.0006|TWO_SIDED|95.0|0.219|0.79|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||0.790|0.219|0.0006
71929541|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.775|||<|0.0001|TWO_SIDED|95.0|0.49|1.06|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.060|0.490|<.0001
71929542|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.116|||<|0.0001|TWO_SIDED|95.0|-2.472|-1.761|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.761|-2.472|<.0001
71929543|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.016|||<|0.0001|TWO_SIDED|95.0|-2.376|-1.656|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.656|-2.376|<.0001
71929544|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.605|||<|0.0001|TWO_SIDED|95.0|-1.958|-1.253|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.253|-1.958|<.0001
71929545|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.642|||<|0.0001|TWO_SIDED|95.0|-2.003|-1.282|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.282|-2.003|<.0001
71929546|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.578|||<|0.0001|TWO_SIDED|95.0|-1.922|-1.234|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.234|-1.922|<.0001
71929547|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.726|||<|0.0001|TWO_SIDED|95.0|-2.074|-1.378|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.378|-2.074|<.0001
71929548|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.479||||0.1579|TWO_SIDED|95.0|-1.054|0.097|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.097|-1.054|0.1579
71689827|NCT00502853|142895945|SUPERIORITY_OR_OTHER|||||||0.6773|||||||Student's t-test|||Change from Baseline at Week 24||||0.6773
71929549|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.628||||0.026|TWO_SIDED|95.0|-1.207|-0.048|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.048|-1.207|0.0260
71929550|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.58||||0.0483|TWO_SIDED|95.0|-1.158|-0.003|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.003|-1.158|0.0483
71929551|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.329||||0.5842|TWO_SIDED|95.0|-0.906|0.249|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.249|-0.906|0.5842
71929552|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-3.201|||<|0.0001|TWO_SIDED|95.0|-3.856|-2.546|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.546|-3.856|<.0001
71929553|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-3.119|||<|0.0001|TWO_SIDED|95.0|-3.779|-2.46|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.460|-3.779|<.0001
71929554|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-2.69|||<|0.0001|TWO_SIDED|95.0|-3.338|-2.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-2.043|-3.338|<.0001
71929555|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-2.746|||<|0.0001|TWO_SIDED|95.0|-3.402|-2.09|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-2.090|-3.402|<.0001
71929556|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.184|||<|0.0001|TWO_SIDED|95.0|1.565|2.803|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||2.803|1.565|<.0001
71929557|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.202|||<|0.0001|TWO_SIDED|95.0|1.576|2.828|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||2.828|1.576|<.0001
71929558|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|2.083|||<|0.0001|TWO_SIDED|95.0|1.461|2.704|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||2.704|1.461|<.0001
71929559|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|2.501|||<|0.0001|TWO_SIDED|95.0|1.876|3.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||3.126|1.876|<.0001
71929560|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.538||||0.2085|TWO_SIDED|95.0|-1.231|0.154|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.154|-1.231|0.2085
71929561|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.289||||0.8557|TWO_SIDED|95.0|-0.988|0.41|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.410|-0.988|0.8557
71929562|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.027||||1|TWO_SIDED|95.0|-0.713|0.658|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.658|-0.713|1.0000
71929563|NCT03692078|143379888|EQUIVALENCE|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.084||||1|TWO_SIDED|95.0|-0.612|0.78|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-MHBMA amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.780|-0.612|1.0000
71929564|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.081|||<|0.0001|TWO_SIDED|95.0|0.679|1.484|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.484|0.679|<.0001
71929565|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.309|||<|0.0001|TWO_SIDED|95.0|0.902|1.716|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.716|0.902|<.0001
71929566|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.996|||<|0.0001|TWO_SIDED|95.0|0.615|1.377|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.377|0.615|<.0001
71929567|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.728||||0.0003|TWO_SIDED|95.0|0.339|1.116|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.116|0.339|0.0003
71929568|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.987|||<|0.0001|TWO_SIDED|95.0|0.593|1.381|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.381|0.593|<.0001
71929569|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.865|||<|0.0001|TWO_SIDED|95.0|0.475|1.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.254|0.475|<.0001
71929570|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.436||||0.0768|TWO_SIDED|95.0|-0.047|0.92|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.920|-0.047|0.0768
71929571|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.091||||0.7155|TWO_SIDED|95.0|-0.4|0.583|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.583|-0.400|0.7155
71929572|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.237||||0.3282|TWO_SIDED|95.0|-0.239|0.713|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.713|-0.239|0.3282
71929573|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.23||||0.3578|TWO_SIDED|95.0|-0.722|0.262|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.262|-0.722|0.3578
71929574|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.338||||0.1638|TWO_SIDED|95.0|-0.138|0.814|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.814|-0.138|0.1638
71689828|NCT00502853|142895945|SUPERIORITY_OR_OTHER||Slope|0.3688|STANDARD_ERROR_OF_MEAN|0.5987||0.5531|||||||Random coefficient model|||Trend over time||||0.5531
71929575|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-0.05||||0.8384|TWO_SIDED|95.0|-0.533|0.433|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.433|-0.533|0.8384
71929576|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.086||||1|TWO_SIDED|95.0|-0.869|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.869|1.0000
71929577|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.581||||0.2808|TWO_SIDED|95.0|-1.377|0.214|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.214|-1.377|0.2808
71929578|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.095||||1|TWO_SIDED|95.0|-0.887|0.698|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.698|-0.887|1.0000
71929579|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.444||||0.6018|TWO_SIDED|95.0|-1.237|0.349|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.349|-1.237|0.6018
71929580|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.645||||0.2935|TWO_SIDED|95.0|-1.536|0.246|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.246|-1.536|0.2935
71929581|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.218||||0.0023|TWO_SIDED|95.0|-2.12|-0.315|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.315|-2.120|0.0023
71929582|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.844||||0.0669|TWO_SIDED|95.0|-1.723|0.035|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||0.035|-1.723|0.0669
71929583|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.539|||<|0.0001|TWO_SIDED|95.0|-2.438|-0.64|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.640|-2.438|<.0001
71929584|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.658||||0.212|TWO_SIDED|95.0|-0.192|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.192|0.2120
71929585|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.778||||0.0993|TWO_SIDED|95.0|-0.087|1.642|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.642|-0.087|0.0993
71929586|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.649||||0.2347|TWO_SIDED|95.0|-0.211|1.509|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.509|-0.211|0.2347
71929587|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.915||||0.032|TWO_SIDED|95.0|0.052|1.778|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.778|0.052|0.0320
71929588|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.099||||1|TWO_SIDED|95.0|-0.849|1.047|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||1.047|-0.849|1.0000
71929589|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.141||||0.9999|TWO_SIDED|95.0|-0.82|1.103|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||1.103|-0.820|0.9999
71929590|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||1|TWO_SIDED|95.0|-1.038|0.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.837|-1.038|1.0000
71929591|NCT03692078|143379890|EQUIVALENCE|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.18||||0.9995|TWO_SIDED|95.0|-1.139|0.779|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-OHFLe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.779|-1.139|0.9995
71929592|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|3.12|||<|0.0001|TWO_SIDED|95.0|2.964|3.276|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||3.276|2.964|<.0001
71929593|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|3.141|||<|0.0001|TWO_SIDED|95.0|2.953|3.328|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||3.328|2.953|<.0001
71929594|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.658|||<|0.0001|TWO_SIDED|95.0|2.511|2.806|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||2.806|2.511|<.0001
71929595|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.638|||<|0.0001|TWO_SIDED|95.0|2.458|2.817|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||2.817|2.458|<.0001
71929596|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|2.754|||<|0.0001|TWO_SIDED|95.0|2.604|2.903|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||2.903|2.604|<.0001
71929597|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|2.652|||<|0.0001|TWO_SIDED|95.0|2.471|2.832|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||2.832|2.471|<.0001
71929598|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.703|||<|0.0001|TWO_SIDED|95.0|1.517|1.889|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||1.889|1.517|<.0001
71929599|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.637|||<|0.0001|TWO_SIDED|95.0|1.41|1.865|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||1.865|1.410|<.0001
71929600|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.656|||<|0.0001|TWO_SIDED|95.0|1.472|1.839|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||1.839|1.472|<.0001
71929601|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.485|||<|0.0001|TWO_SIDED|95.0|1.259|1.711|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||1.711|1.259|<.0001
71929602|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.713|||<|0.0001|TWO_SIDED|95.0|1.532|1.895|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||1.895|1.532|<.0001
71929603|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.617|||<|0.0001|TWO_SIDED|95.0|1.397|1.837|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||1.837|1.397|<.0001
71929604|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.462||||0.0003|TWO_SIDED|95.0|-0.766|-0.158|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.158|-0.766|0.0003
71929605|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.503||||0.0018|TWO_SIDED|95.0|-0.867|-0.139|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.139|-0.867|0.0018
71929606|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.366||||0.0089|TWO_SIDED|95.0|-0.67|-0.062|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.062|-0.670|0.0089
71929607|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.489||||0.0025|TWO_SIDED|95.0|-0.851|-0.126|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.126|-0.851|0.0025
71929608|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.417|||<|0.0001|TWO_SIDED|95.0|-1.762|-1.072|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.072|-1.762|<.0001
71929609|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.504|||<|0.0001|TWO_SIDED|95.0|-1.916|-1.091|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.091|-1.916|<.0001
71929610|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.464|||<|0.0001|TWO_SIDED|95.0|-1.804|-1.125|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.125|-1.804|<.0001
71929611|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.656|||<|0.0001|TWO_SIDED|95.0|-2.065|-1.247|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.247|-2.065|<.0001
71929612|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.945|||<|0.0001|TWO_SIDED|95.0|0.617|1.273|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.273|0.617|<.0001
71929613|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.021|||<|0.0001|TWO_SIDED|95.0|0.628|1.413|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.413|0.628|<.0001
71929614|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|1.041|||<|0.0001|TWO_SIDED|95.0|0.712|1.369|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.369|0.712|<.0001
71929615|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.035|||<|0.0001|TWO_SIDED|95.0|0.644|1.426|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.426|0.644|<.0001
71929616|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.01||||1|TWO_SIDED|95.0|-0.376|0.355|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.355|-0.376|1.0000
71929617|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.02||||1|TWO_SIDED|95.0|-0.417|0.457|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.457|-0.417|1.0000
71929618|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.058||||0.9999|TWO_SIDED|95.0|-0.418|0.303|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.303|-0.418|0.9999
71689829|NCT00502853|142895946|SUPERIORITY_OR_OTHER|||||||0.5002|||||||Student's t-test|||Change from Baseline at Week 24||||0.5002
71689830|NCT00502853|142895947|SUPERIORITY_OR_OTHER|||||||1|||||||Student's t-test|||Change from Baseline at Week 24||||1.0000
71929619|NCT03692078|143379892|EQUIVALENCE|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.132||||0.9669|TWO_SIDED|95.0|-0.566|0.301|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 2-Naphthol amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.301|-0.566|0.9669
71929620|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.442|||<|0.0001|TWO_SIDED|95.0|-1.604|-1.279|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-1.279|-1.604|<.0001
71929621|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.413|||<|0.0001|TWO_SIDED|95.0|-1.576|-1.251|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-1.251|-1.576|<.0001
71929622|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.754|||<|0.0001|TWO_SIDED|95.0|-1.907|-1.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-1.600|-1.907|<.0001
71929623|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.816|||<|0.0001|TWO_SIDED|95.0|-1.972|-1.659|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-1.659|-1.972|<.0001
71929624|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.654|||<|0.0001|TWO_SIDED|95.0|-1.81|-1.498|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-1.498|-1.810|<.0001
71929625|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.829|||<|0.0001|TWO_SIDED|95.0|-1.986|-1.673|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-1.673|-1.986|<.0001
71929626|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.184|||<|0.0001|TWO_SIDED|95.0|-2.379|-1.989|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.989|-2.379|<.0001
71929627|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.27|||<|0.0001|TWO_SIDED|95.0|-2.468|-2.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-2.071|-2.468|<.0001
71689831|NCT00502853|142895948|SUPERIORITY_OR_OTHER|||||||0.7002|||||||Student's t-test|||Change from Baseline at Week 24||||0.7002
71929628|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.413|||<|0.0001|TWO_SIDED|95.0|-2.607|-2.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-2.219|-2.607|<.0001
71929629|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.349|||<|0.0001|TWO_SIDED|95.0|-2.549|-2.149|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-2.149|-2.549|<.0001
71929630|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-2.227|||<|0.0001|TWO_SIDED|95.0|-2.416|-2.038|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-2.038|-2.416|<.0001
71929631|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-2.154|||<|0.0001|TWO_SIDED|95.0|-2.345|-1.962|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-1.962|-2.345|<.0001
71929632|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.312||||0.0552|TWO_SIDED|95.0|-0.628|0.004|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.004|-0.628|0.0552
71929633|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.402||||0.0055|TWO_SIDED|95.0|-0.722|-0.083|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.083|-0.722|0.0055
71929634|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.212||||0.3834|TWO_SIDED|95.0|-0.53|0.105|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.105|-0.530|0.3834
71929635|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.416||||0.0033|TWO_SIDED|95.0|-0.734|-0.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.099|-0.734|0.0033
71929636|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.743|||<|0.0001|TWO_SIDED|95.0|-1.103|-0.382|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.382|-1.103|<.0001
71689832|NCT00502853|142895949|SUPERIORITY_OR_OTHER|||||||0.3132|||||||Student's t-test|||Change from Baseline at Week 24||||0.3132
71929637|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.857|||<|0.0001|TWO_SIDED|95.0|-1.22|-0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.493|-1.220|<.0001
71929638|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.971|||<|0.0001|TWO_SIDED|95.0|-1.327|-0.616|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.616|-1.327|<.0001
71929639|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.936|||<|0.0001|TWO_SIDED|95.0|-1.298|-0.574|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.574|-1.298|<.0001
71929640|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.473||||0.0016|TWO_SIDED|95.0|0.133|0.813|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.813|0.133|0.0016
71929641|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.338||||0.0582|TWO_SIDED|95.0|-0.007|0.683|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.683|-0.007|0.0582
71929642|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.573|||<|0.0001|TWO_SIDED|95.0|0.232|0.914|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.914|0.232|<.0001
71929643|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.324||||0.0745|TWO_SIDED|95.0|-0.02|0.668|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.668|-0.020|0.0745
71929644|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.043||||1|TWO_SIDED|95.0|-0.337|0.422|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.422|-0.337|1.0000
71929645|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.116||||0.9759|TWO_SIDED|95.0|-0.501|0.268|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.268|-0.501|0.9759
71929646|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.186||||0.7128|TWO_SIDED|95.0|-0.565|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.192|-0.565|0.7128
71929647|NCT03692078|143379894|EQUIVALENCE|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.195||||0.6816|TWO_SIDED|95.0|-0.582|0.192|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHPhe amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.192|-0.582|0.6816
71929648|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-0.948|||<|0.0001|TWO_SIDED|95.0|-1.146|-0.75|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||-0.750|-1.146|<.0001
71929649|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.019|||<|0.0001|TWO_SIDED|95.0|-1.242|-0.796|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||-0.796|-1.242|<.0001
71929650|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.172|||<|0.0001|TWO_SIDED|95.0|-1.358|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||-0.986|-1.358|<.0001
71929651|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.196|||<|0.0001|TWO_SIDED|95.0|-1.409|-0.983|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||-0.983|-1.409|<.0001
71929652|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.049|||<|0.0001|TWO_SIDED|95.0|-1.239|-0.859|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||-0.859|-1.239|<.0001
71929653|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.414|-0.986|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||-0.986|-1.414|<.0001
71929654|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.337|||<|0.0001|TWO_SIDED|95.0|-1.574|-1.099|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||-1.099|-1.574|<.0001
71929655|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.345|||<|0.0001|TWO_SIDED|95.0|-1.616|-1.075|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||-1.075|-1.616|<.0001
71929656|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.452|||<|0.0001|TWO_SIDED|95.0|-1.685|-1.219|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||-1.219|-1.685|<.0001
71929657|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.608|-1.071|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||-1.071|-1.608|<.0001
71929658|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|-1.348|||<|0.0001|TWO_SIDED|95.0|-1.577|-1.118|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||-1.118|-1.577|<.0001
71929659|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|-1.227|||<|0.0001|TWO_SIDED|95.0|-1.488|-0.966|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is equal to zero on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||-0.966|-1.488|<.0001
71929660|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.224||||0.5646|TWO_SIDED|95.0|-0.607|0.16|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||0.160|-0.607|0.5646
71929661|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.177||||0.8765|TWO_SIDED|95.0|-0.609|0.254|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||0.254|-0.609|0.8765
71929662|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.101||||0.9954|TWO_SIDED|95.0|-0.488|0.287|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||0.287|-0.488|0.9954
71929663|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.181||||0.8665|TWO_SIDED|95.0|-0.613|0.252|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||0.252|-0.613|0.8665
71929664|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.389||||0.1165|TWO_SIDED|95.0|-0.829|0.052|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||0.052|-0.829|0.1165
71929665|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.326||||0.3896|TWO_SIDED|95.0|-0.821|0.168|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||0.168|-0.821|0.3896
71929666|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.504||||0.0122|TWO_SIDED|95.0|-0.934|-0.074|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.074|-0.934|0.0122
71929667|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32||||0.3938|TWO_SIDED|95.0|-0.807|0.167|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||0.167|-0.807|0.3938
71929668|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.176||||0.8501|TWO_SIDED|95.0|-0.237|0.589|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||0.589|-0.237|0.8501
71929669|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.031||||1|TWO_SIDED|95.0|-0.435|0.496|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||0.496|-0.435|1.0000
71689833|NCT00502853|142895950|SUPERIORITY_OR_OTHER|||||||0.8597|||||||Student's t-test|||Change from Baseline at Week 24||||0.8597
71929670|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.299||||0.2928|TWO_SIDED|95.0|-0.117|0.715|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||0.715|-0.117|0.2928
71929671|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.027||||1|TWO_SIDED|95.0|-0.439|0.493|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||0.493|-0.439|1.0000
71929672|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.011||||1|TWO_SIDED|95.0|-0.453|0.475|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.475|-0.453|1.0000
71929673|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.118||||0.9966|TWO_SIDED|95.0|-0.64|0.403|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.403|-0.640|0.9966
71929674|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.104||||0.9976|TWO_SIDED|95.0|-0.56|0.352|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.352|-0.560|0.9976
71929675|NCT03692078|143379896|EQUIVALENCE|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-0.112||||0.9976|TWO_SIDED|95.0|-0.628|0.404|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: 1-OHP amount excreted (ug/24 hour) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.404|-0.628|0.9976
71929676|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|180.0|||<|0.0001|TWO_SIDED|95.0|164.9|195.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||195.2|164.9|<.0001
71929677|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|181.1|||<|0.0001|TWO_SIDED|95.0|165.9|196.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||196.2|165.9|<.0001
71689834|NCT00502853|142895951|SUPERIORITY_OR_OTHER|||||||0.3617|||||||Student's t-test|||Change from Baseline at Week 24||||0.3617
71689835|NCT03373461|142896031|OTHER|||||||0.038|||||||Multiple Comparison Procedure-Modeling|||||||0.038
71929678|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|132.3|||<|0.0001|TWO_SIDED|95.0|117.2|147.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||147.5|117.2|<.0001
71929679|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|137.3|||<|0.0001|TWO_SIDED|95.0|122.1|152.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||152.5|122.1|<.0001
71929680|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|136.8|||<|0.0001|TWO_SIDED|95.0|122.0|151.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||151.7|122.0|<.0001
71929681|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|150.8|||<|0.0001|TWO_SIDED|95.0|136.0|165.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||165.7|136.0|<.0001
71929682|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|43.2|||<|0.0001|TWO_SIDED|95.0|25.1|61.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||61.4|25.1|<.0001
71929683|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|61.7|||<|0.0001|TWO_SIDED|95.0|43.2|80.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||80.1|43.2|<.0001
71929684|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|36.9|||<|0.0001|TWO_SIDED|95.0|18.6|55.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||55.1|18.6|<.0001
71929685|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|35.5||||0.0002|TWO_SIDED|95.0|16.7|54.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||54.3|16.7|0.0002
71929686|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|38.8|||<|0.0001|TWO_SIDED|95.0|19.9|57.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||57.6|19.9|<.0001
71929687|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|44.9|||<|0.0001|TWO_SIDED|95.0|26.0|63.8|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||63.8|26.0|<.0001
71929688|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-47.7||||0.0002|TWO_SIDED|95.0|-78.0|-17.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-17.4|-78.0|0.0002
71929689|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-43.8||||0.0009|TWO_SIDED|95.0|-74.1|-13.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-13.4|-74.1|0.0009
71929690|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-43.2||||0.0009|TWO_SIDED|95.0|-73.2|-13.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-13.3|-73.2|0.0009
71929691|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-30.2||||0.0466|TWO_SIDED|95.0|-60.2|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.3|-60.2|0.0466
71929692|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-136.8|||<|0.0001|TWO_SIDED|95.0|-170.4|-103.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-103.3|-170.4|<.0001
71929693|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-119.4|||<|0.0001|TWO_SIDED|95.0|-153.3|-85.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-85.5|-153.3|<.0001
71689836|NCT03373461|142896031|OTHER||Ratio to placebo (of ratio to baseline)|0.99|||||TWO_SIDED|80.0|0.86|1.0||||||||1.00|0.86|
71689837|NCT03373461|142896031|OTHER||Ratio to placebo (of ratio to baseline)|0.94|||||TWO_SIDED|80.0|0.76|0.98||||||||0.98|0.76|
71929694|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-143.2|||<|0.0001|TWO_SIDED|95.0|-176.6|-109.7|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-109.7|-176.6|<.0001
71929695|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-145.6|||<|0.0001|TWO_SIDED|95.0|-179.7|-111.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-111.4|-179.7|<.0001
71929696|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|93.6|||<|0.0001|TWO_SIDED|95.0|60.0|127.2|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||127.2|60.0|<.0001
71929697|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|92.4|||<|0.0001|TWO_SIDED|95.0|58.8|126.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||126.1|58.8|<.0001
71929698|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|98.1|||<|0.0001|TWO_SIDED|95.0|64.6|131.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||131.5|64.6|<.0001
71929699|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|106.0|||<|0.0001|TWO_SIDED|95.0|72.5|139.4|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||139.4|72.5|<.0001
71929700|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|4.5||||1|TWO_SIDED|95.0|-32.0|40.9|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||40.9|-32.0|1.0000
71929701|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|16.8||||0.7714|TWO_SIDED|95.0|-20.0|53.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||53.5|-20.0|0.7714
71929702|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-1.9||||1|TWO_SIDED|95.0|-38.3|34.5|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||34.5|-38.3|1.0000
71929703|NCT03692078|143379898|EQUIVALENCE|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|-9.4||||0.9926|TWO_SIDED|95.0|-46.4|27.6|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Urine Mutagenicity (revertants/24 hours) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||27.6|-46.4|0.9926
71929704|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.872|||<|0.0001|TWO_SIDED|95.0|1.81|1.935|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 5. (mITT Population)||1.935|1.810|<.0001
71929705|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.913|||<|0.0001|TWO_SIDED|95.0|1.851|1.976|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 1 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 1 is NOT equal to zero on Day 7. (mITT Population)||1.976|1.851|<.0001
71929706|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.467|||<|0.0001|TWO_SIDED|95.0|1.408|1.525|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 5. (mITT Population)||1.525|1.408|<.0001
71929707|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.493|||<|0.0001|TWO_SIDED|95.0|1.434|1.551|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to zero on Day 7. (mITT Population)||1.551|1.434|<.0001
71929708|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|1.55|||<|0.0001|TWO_SIDED|95.0|1.49|1.609|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 5. (mITT Population)||1.609|1.490|<.0001
71929709|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|1.594|||<|0.0001|TWO_SIDED|95.0|1.533|1.654|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to zero on Day 7. (mITT Population)||1.654|1.533|<.0001
71689838|NCT03373461|142896031|OTHER||Ratio to placebo (of ratio to baseline)|0.87|||||TWO_SIDED|80.0|0.72|0.96||||||||0.96|0.72|
71689839|NCT03373461|142896031|OTHER||Ratio to placebo (of ratio to baseline)|0.77|||||TWO_SIDED|80.0|0.66|0.92||||||||0.92|0.66|
71929710|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.557|||<|0.0001|TWO_SIDED|95.0|0.482|0.631|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 5. (mITT Population)||0.631|0.482|<.0001
71929711|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.589|||<|0.0001|TWO_SIDED|95.0|0.514|0.665|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to zero on Day 7. (mITT Population)||0.665|0.514|<.0001
71929712|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.533|||<|0.0001|TWO_SIDED|95.0|0.461|0.605|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 5. (mITT Population)||0.605|0.461|<.0001
71929713|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.588|||<|0.0001|TWO_SIDED|95.0|0.514|0.662|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to zero on Day 7. (mITT Population)||0.662|0.514|<.0001
71929714|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.508|0.652|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 5. (mITT Population)||0.652|0.508|<.0001
71929715|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)|Mean Difference (Net)|0.58|||<|0.0001|TWO_SIDED|95.0|0.507|0.653|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 6 is equal to zero on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 6 is NOT equal to zero on Day 7. (mITT Population)||0.653|0.507|<.0001
71929716|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.406|||<|0.0001|TWO_SIDED|95.0|-0.526|-0.285|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.285|-0.526|<.0001
71929717|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.421|||<|0.0001|TWO_SIDED|95.0|-0.541|-0.3|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.300|-0.541|<.0001
71929718|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-0.323|||<|0.0001|TWO_SIDED|95.0|-0.444|-0.201|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 5. (mITT Population)||-0.201|-0.444|<.0001
71929719|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-0.32|||<|0.0001|TWO_SIDED|95.0|-0.442|-0.198|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 1 on Day 7. (mITT Population)||-0.198|-0.442|<.0001
71929720|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.315|||<|0.0001|TWO_SIDED|95.0|-1.453|-1.178|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.178|-1.453|<.0001
71929721|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.324|||<|0.0001|TWO_SIDED|95.0|-1.463|-1.186|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.186|-1.463|<.0001
71929722|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)|Mean Difference (Net)|-1.339|||<|0.0001|TWO_SIDED|95.0|-1.473|-1.205|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 5. (mITT Population)||-1.205|-1.473|<.0001
71929723|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)|Mean Difference (Net)|-1.325|||<|0.0001|TWO_SIDED|95.0|-1.461|-1.19|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 1 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 1 on Day 7. (mITT Population)||-1.190|-1.461|<.0001
71929724|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.887|||<|0.0001|TWO_SIDED|95.0|0.757|1.016|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 5. (mITT Population)||1.016|0.757|<.0001
71929725|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.912|||<|0.0001|TWO_SIDED|95.0|0.782|1.043|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 2 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 2 is NOT equal to Group 6 on Day 7. (mITT Population)||1.043|0.782|<.0001
71929726|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|0.97|||<|0.0001|TWO_SIDED|95.0|0.839|1.1|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 5. (mITT Population)||1.100|0.839|<.0001
71929727|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|1.013|||<|0.0001|TWO_SIDED|95.0|0.882|1.145|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 3 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 3 is NOT equal to Group 6 on Day 7. (mITT Population)||1.145|0.882|<.0001
71929728|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.023||||0.9999|TWO_SIDED|95.0|-0.168|0.122|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 5. (mITT Population)||0.122|-0.168|0.9999
71929729|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.009||||1|TWO_SIDED|95.0|-0.138|0.155|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 4 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 4 is NOT equal to Group 6 on Day 7. (mITT Population)||0.155|-0.138|1.0000
71929730|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)|Mean Difference (Net)|-0.047||||0.9577|TWO_SIDED|95.0|-0.189|0.095|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 5. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 5. (mITT Population)||0.095|-0.189|0.9577
71929731|NCT03692078|143379900|EQUIVALENCE|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)|Mean Difference (Net)|0.008||||1|TWO_SIDED|95.0|-0.136|0.152|||Mixed Models Analysis||LSM calculated from the mixed model for repeated measures that includes study group, day, group by day interaction, and gender as fixed effects, log transformed baseline value as covariate, with a covariance matrix based on the AIC value.|Null hypothesis: Whole Blood COHB (% Saturation) in Group 5 is equal to Group 6 on Day 7. Alternate hypothesis: Whole Blood COHB (% Saturation) in Group 5 is NOT equal to Group 6 on Day 7. (mITT Population)||0.152|-0.136|1.0000
71929732|NCT01005680|143379908|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.822|TWO_SIDED|95.0|0.77|1.39||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.39|0.77|0.822
71929733|NCT01005680|143379909|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.64|TWO_SIDED|95.0|0.82|1.37||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.37|0.82|0.640
71929734|NCT01005680|143379910|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.78|1.32||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.|Cox Proportional Hazard|||||1.32|0.78|0.928
71929735|NCT01005680|143379911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.51|1.79||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.79|0.51|0.887
71929736|NCT01005680|143379912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.861|TWO_SIDED|95.0|0.67|1.61||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard|||||1.61|0.67|0.861
71929737|NCT01005680|143379913|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||two-sided Z test|||||||0.451
71929738|NCT01005680|143379915|SUPERIORITY_OR_OTHER|||||||0.627||95.0|||||two-sided Z test|||||||0.627
71929739|NCT01339858|143379937|SUPERIORITY|||||||0.32|||||||ANOVA|||||||0.32
71929740|NCT01965431|143379982|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.|Mean Difference (Net)|7.9|STANDARD_ERROR_OF_MEAN|1.52|||TWO_SIDED|90.0|5.37|10.43|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|||10.43|5.37|
71929741|NCT01965431|143379983|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|2.02|||TWO_SIDED|90.0|9.32|16.08|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||16.08|9.32|
71929742|NCT01965431|143379984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-1.38|1.73|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||1.73|-1.38|
71929743|NCT01965431|143379985|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.42|STANDARD_ERROR_OF_MEAN|0.94|||TWO_SIDED|90.0|-5.98|-2.87|||||Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' \& 'period-global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.||-2.87|-5.98|
71929744|NCT04342130|143380020|OTHER||||||>|0.05|||||||t-test, 2 sided|||||||>0.05
71929745|NCT03901339|143380024|OTHER||Hazard Ratio (HR)|0.653||||0.0001|TWO_SIDED|95.0|0.526|0.812||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.812|0.526|0.0001
71929746|NCT03901339|143380025|OTHER||Hazard Ratio (HR)|0.788||||0.0133|TWO_SIDED|95.0|0.652|0.952||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.952|0.652|0.0133
71929747|NCT03901339|143380026|OTHER||Odds Ratio (OR)|1.662||||0.0268|TWO_SIDED|95.0|1.058|2.609|||Cochran-Mantel-Haenszel|||ORR by BICR Assessment||2.609|1.058|0.0268
71929748|NCT03901339|143380026|OTHER||Odds Ratio (OR)|1.989||||0.0098|TWO_SIDED|95.0|1.174|3.369|||Cochran-Mantel-Haenszel|||ORR by LIR Assessment||3.369|1.174|0.0098
71929749|NCT03901339|143380028|OTHER||Odds Ratio (OR)|1.796||||0.0025|TWO_SIDED|95.0|1.227|2.628|||Cochran-Mantel-Haenszel|||CBR by BICR Assessment||2.628|1.227|0.0025
71929750|NCT03901339|143380028|OTHER||Odds Ratio (OR)|1.834||||0.0024|TWO_SIDED|95.0|1.237|2.717|||Cochran-Mantel-Haenszel|||CBR by LIR Assessment||2.717|1.237|0.0024
71929751|NCT03901339|143380029|OTHER||Hazard Ratio (HR)|0.728||||0.001|TWO_SIDED|95.0|0.602|0.881||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.881|0.602|0.0010
71929752|NCT03901339|143380030|OTHER||Hazard Ratio (HR)|0.751||||0.0059|TWO_SIDED|95.0|0.612|0.922||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.922|0.612|0.0059
71929753|NCT03901339|143380031|OTHER||Hazard Ratio (HR)|0.918||||0.4151|TWO_SIDED|95.0|0.748|1.126||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||1.126|0.748|0.4151
71929754|NCT03901339|143380032|OTHER||Hazard Ratio (HR)|0.732||||0.0021|TWO_SIDED|95.0|0.598|0.894||Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.|Log Rank|||||0.894|0.598|0.0021
71929755|NCT03123120|143380078|OTHER||Risk Difference (RD)|-0.232|||||TWO_SIDED|95.0|-0.568|0.118|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.118|-0.568|
71929756|NCT03123120|143380079|OTHER||Risk Difference (RD)|-0.054|||||TWO_SIDED|95.0|-0.404|0.21|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.210|-0.404|
71929757|NCT03123120|143380080|OTHER||Risk Difference (RD)|-0.286|||||TWO_SIDED|95.0|-0.602|0.101|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.101|-0.602|
71929758|NCT03123120|143380081|OTHER||Risk Difference (RD)|0.143|||||TWO_SIDED|95.0|-0.197|0.399|||||Risk difference was calculated as the observed proportion of response from Spesolimab minus the one from Placebo. Newcombe method was used in the calculation of the 95% confidence interval around the risk difference.|||0.399|-0.197|
71929759|NCT00806416|143380083|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and the 70 mg alendronate market tablet, the GMR of the combination tablet/alendronate only tablet are contained within \[0.80,1.25\].|Least square mean ratio|1.03||||||90.0|0.91|1.17||||||If the true geometric mean ratio (GMR) for total urinary excretion of alendronate of 70 mg alendronate/vitamin D3 combination tablet with respect to alendronate alone is 1.00 then a sample size =208 provided 99% probability of yielding a 90% CI for the total urinary excretion GMR within the interval of \[0.80, 1.25\]. These calculations were based on the observed-pooled within-subject standard deviation (log scale) of 0.521 obtained from earlier Phase 1 studies.||1.17|0.91|
71929760|NCT00806416|143380084|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|Least square mean ratio for AUC0-120 hr|0.88||||||90.0|0.81|0.95||||||If the true GMRs for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample size=28 provided \>99% probability of yielding a 90% CI for both AUC(0-120 hr) and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC(0-120 hr) (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.81|
71929761|NCT00806416|143380085|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within \[0.80,1.25\].|least-squares mean for Cmax|0.89||||||90.0|0.84|0.95||||||If the true GMR ratios for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample of N=28 provided \>99% probability of yielding a 90% CI for both AUC0-120 hr and Cmax GMRs within the interval of \[0.80, 1.25\]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC0-120 hr (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.||0.95|0.84|
71929762|NCT00442338|143380091|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.01||||0.871|TWO_SIDED|95.0|-0.07|0.08|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the least square (LS) means of time weighted average change FEV1 (0-60 min) using an Analysis of Covariance (ANCOVA) model.||0.08|-0.07|0.871
71929763|NCT00442338|143380091|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.01||||0.794|TWO_SIDED|95.0|-0.08|0.06|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.06|-0.08|0.794
71929764|NCT00442338|143380091|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.02||||0.675|TWO_SIDED|95.0|-0.06|0.09|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.||0.09|-0.06|0.675
71929765|NCT01125358|143380092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.02|||||TWO_SIDED|90.0|-3.37|0.0|||Multiple Comparisons with The Best (MCB)|LS mean difference = LS mean of 10 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.00|-3.37|
71929766|NCT01125358|143380092|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.05|||||TWO_SIDED|90.0|-2.42|0.32|||Multiple Comparison with The Best (MCB)|LS mean difference = LS mean of 160 mg LY2140023 - LS mean of 80 mg LY2140023.||||0.32|-2.42|
71929767|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-9.84|STANDARD_ERROR_OF_MEAN|7.96||0.222|TWO_SIDED|95.0|-25.8|6.12||P-value is for PANSS Total Score.|MMRM|||||6.12|-25.80|0.222
71929768|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-11.91|STANDARD_ERROR_OF_MEAN|7.22||0.105|TWO_SIDED|95.0|-26.42|2.6||P-value is for PANSS Total Score.|MMRM|||||2.60|-26.42|0.105
71929769|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-7.96|STANDARD_ERROR_OF_MEAN|7.73||0.308|TWO_SIDED|95.0|-23.46|7.55||P-value is for PANSS Total Score.|MMRM|||||7.55|-23.46|0.308
71929770|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.6|STANDARD_ERROR_OF_MEAN|2.06||0.441|TWO_SIDED|95.0|-5.74|2.54||P-value is for PANSS Positive Subscore.|MMRM|||||2.54|-5.74|0.441
71929771|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-4.22|STANDARD_ERROR_OF_MEAN|1.88||0.03||95.0|-8.01|-0.44||P-value is for PANSS Positive Subscore.|MMRM|||||-0.44|-8.01|0.030
71929772|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-1.98|STANDARD_ERROR_OF_MEAN|1.98||0.323|TWO_SIDED|95.0|-5.96|2.01||P-value is for PANSS Positive Subscore.|MMRM|||||2.01|-5.96|0.323
71929773|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.46|STANDARD_ERROR_OF_MEAN|2.28||0.285|TWO_SIDED|95.0|-7.05|2.12||P-value is for PANSS Negative Subscore.|MMRM|||||2.12|-7.05|0.285
71929774|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.92|STANDARD_ERROR_OF_MEAN|2.07||0.166|TWO_SIDED|95.0|-7.1|1.26||P-value is for PANSS Negative Subscore.|MMRM|||||1.26|-7.10|0.166
71929775|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-2.37|STANDARD_ERROR_OF_MEAN|2.2||0.286|TWO_SIDED|95.0|-6.79|2.05||P-value is for PANSS Negative Subscore.|MMRM|||||2.05|-6.79|0.286
71929776|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.67|STANDARD_ERROR_OF_MEAN|4.14||0.177|TWO_SIDED|95.0|-13.96|2.63||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.63|-13.96|0.177
71929777|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.1|STANDARD_ERROR_OF_MEAN|3.74||0.178|TWO_SIDED|95.0|-12.6|2.4||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||2.40|-12.60|0.178
71929778|NCT01125358|143380093|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.61|STANDARD_ERROR_OF_MEAN|4.05||0.377|TWO_SIDED|95.0|-11.72|4.51||P-value is for PANSS General Psychopathology Subscore.|MMRM|||||4.51|-11.72|0.377
71929779|NCT01125358|143380094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.87|STANDARD_ERROR_OF_MEAN|0.48||0.077|TWO_SIDED|95.0|-0.1|1.83|||MMRM|||||1.83|-0.10|0.077
71929780|NCT01125358|143380094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.24|STANDARD_ERROR_OF_MEAN|0.44||0.592|TWO_SIDED|95.0|-1.12|0.65|||MMRM|||||0.65|-1.12|0.592
71929781|NCT01125358|143380094|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.39|STANDARD_ERROR_OF_MEAN|0.46||0.395|TWO_SIDED|95.0|-0.53|1.32|||MMRM|||||1.32|-0.53|0.395
71929782|NCT01125358|143380095|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|4.64|STANDARD_ERROR_OF_MEAN|4.49||0.306|TWO_SIDED|95.0|-4.37|13.65|||MMRM|||||13.65|-4.37|0.306
71929783|NCT01125358|143380095|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.82|STANDARD_ERROR_OF_MEAN|4.26||0.849|TWO_SIDED|95.0|-7.74|9.38|||MMRM|||||9.38|-7.74|0.849
71929784|NCT01125358|143380095|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-5.09|STANDARD_ERROR_OF_MEAN|4.46||0.259||95.0|-14.05|3.86|||MMRM|||||3.86|-14.05|0.259
71929785|NCT01125358|143380097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.354||95.0|||||Fisher Exact|||||||0.354
71929786|NCT01125358|143380097|SUPERIORITY_OR_OTHER_LEGACY|||||||0.181||95.0|||||Fisher Exact|||||||0.181
71929787|NCT01125358|143380097|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.999||95.0|||||Fisher Exact|||||||>0.999
71929788|NCT00962013|143380100|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority margin is 7%||||||0.0136|||||||Exact Binomial|||This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.||||0.0136
71929789|NCT00962013|143380102|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from HHS pre-op to HHS 5 year||||<0.0001
71929790|NCT00962013|143380103|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores||||<0.0001
71929791|NCT00962013|143380105|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Exact Binomial|||Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)||||<0.0001
71929792|NCT03706209|143380112|SUPERIORITY||Odds Ratio (OR)|4.12||||0.161|TWO_SIDED|95.0|0.47|35.97|||Cochran-Mantel-Haenszel|||||35.97|0.47|0.161
71929793|NCT03706209|143380112|SUPERIORITY||Odds Ratio (OR)|5.52||||0.111|TWO_SIDED|95.0|0.55|55.43|||Cochran-Mantel-Haenszel|||||55.43|0.55|0.111
71929794|NCT03706209|143380113|SUPERIORITY||Odds Ratio (OR)|1.73||||0.222|TWO_SIDED|95.0|0.71|4.25|||Cochran-Mantel-Haenszel|||||4.25|0.71|0.222
71929795|NCT03706209|143380113|SUPERIORITY||Odds Ratio (OR)|1.91||||0.182|TWO_SIDED|95.0|0.75|4.91|||Cochran-Mantel-Haenszel|||||4.91|0.75|0.182
71929796|NCT03706209|143380114|SUPERIORITY||Odds Ratio (OR)|2.91||||0.294|TWO_SIDED|95.0|0.33|25.39|||Cochran-Mantel-Haenszel|||||25.39|0.33|0.294
71929797|NCT03706209|143380114|SUPERIORITY||Odds Ratio (OR)|4.06||||0.291|TWO_SIDED|95.0|0.31|53.14|||Cochran-Mantel-Haenszel|||||53.14|0.31|0.291
71929798|NCT03706209|143380115|SUPERIORITY||Odds Ratio (OR)|1.31||||0.617|TWO_SIDED|95.0|0.45|3.77|||Cochran-Mantel-Haenszel|||||3.77|0.45|0.617
71929799|NCT03706209|143380115|SUPERIORITY||Odds Ratio (OR)|1.73||||0.319|TWO_SIDED|95.0|0.6|5.0|||Cochran-Mantel-Haenszel|||||5|0.6|0.319
71929800|NCT03706209|143380116|SUPERIORITY||Odds Ratio (OR)|1.5||||0.47|TWO_SIDED|95.0|0.5|4.52|||Cochran-Mantel-Haenszel|||||4.52|0.5|0.47
71929801|NCT03706209|143380116|SUPERIORITY||Odds Ratio (OR)|2.44||||0.136|TWO_SIDED|95.0|0.76|7.82|||Cochran-Mantel-Haenszel|||||7.82|0.76|0.136
71929802|NCT03706209|143380117|SUPERIORITY||least square means|0.2|STANDARD_ERROR_OF_MEAN|1.4||0.894|TWO_SIDED|95.0|-2.6|3.0|||ANCOVA|||||3|-2.6|0.894
71929803|NCT03706209|143380117|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.4||0.456|TWO_SIDED|95.0|-3.8|1.7|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.7|-3.8|0.456
71929804|NCT03706209|143380119|SUPERIORITY|||||||0.572|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.572
71689840|NCT03373461|142896032|OTHER||Mean Difference (Final Values)|3.28|||||TWO_SIDED|80.0|0.21|6.344||||||||6.344|0.210|
71689841|NCT03373461|142896032|OTHER||Mean Difference (Final Values)|5.83|||||TWO_SIDED|80.0|2.642|9.01||||||||9.010|2.642|
71689842|NCT03373461|142896032|OTHER||Mean Difference (Final Values)|3.56|||||TWO_SIDED|80.0|0.427|6.7||||||||6.700|0.427|
71689843|NCT03373461|142896032|OTHER||Mean Difference (Final Values)|5.76|||||TWO_SIDED|80.0|2.882|8.638||||||||8.638|2.882|
71689844|NCT03373461|142896033|OTHER||Mean Difference (Final Values)|-9.2|||||TWO_SIDED|80.0|-15.253|-3.145||||||||-3.145|-15.253|
71689845|NCT03373461|142896033|OTHER||Mean Difference (Final Values)|-9.25|||||TWO_SIDED|80.0|-15.499|-3.0||||||||-3.000|-15.499|
71689846|NCT03373461|142896033|OTHER||Mean Difference (Final Values)|-5.89|||||TWO_SIDED|80.0|-12.04|0.26||||||||0.260|-12.040|
71689847|NCT03373461|142896033|OTHER||Mean Difference (Final Values)|-10.12|||||TWO_SIDED|80.0|-15.763|-4.471||||||||-4.471|-15.763|
71689848|NCT03373461|142896035|OTHER||Ratio to placebo (of ratio to baseline)|0.95|||||TWO_SIDED|80.0|0.742|1.222||||||||1.222|0.742|
71689849|NCT03373461|142896035|OTHER||Ratio to placebo (of ratio to baseline)|1.06|||||TWO_SIDED|80.0|0.83|1.356||||||||1.356|0.830|
71689850|NCT03373461|142896035|OTHER||Ratio to placebo (of ratio to baseline)|0.73|||||TWO_SIDED|80.0|0.569|0.928||||||||0.928|0.569|
71689851|NCT03373461|142896035|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.669|1.05||||||||1.050|0.669|
71689852|NCT03373461|142896036|OTHER||Ratio to placebo (of ratio to baseline)|0.96|||||TWO_SIDED|80.0|0.741|1.25||||||||1.250|0.741|
71689853|NCT03373461|142896036|OTHER||Ratio to placebo (of ratio to baseline)|1.13|||||TWO_SIDED|80.0|0.872|1.458||||||||1.458|0.872|
71689854|NCT03373461|142896036|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.574|0.957||||||||0.957|0.574|
71689855|NCT03373461|142896036|OTHER||Ratio to placebo (of ratio to baseline)|0.89|||||TWO_SIDED|80.0|0.706|1.132||||||||1.132|0.706|
71929805|NCT03706209|143380119|SUPERIORITY|||||||0.4494|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 75 criterion was not computed since data were too sparse.||||||0.4494
71929806|NCT03706209|143380120|SUPERIORITY|||||||0.7922|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.7922
71929807|NCT03706209|143380120|SUPERIORITY|||||||0.1425|||||||Log Rank|Kaplan-Meier estimate of the median time (day) to reach the PASI 50 criterion was not computed since data were too sparse.||||||0.1425
71929808|NCT03706209|143380121|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.992|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.992
71929809|NCT03706209|143380121|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.143|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.143
71929810|NCT03706209|143380124|SUPERIORITY|||||||0.178|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||||||0.178
71929811|NCT03706209|143380124|SUPERIORITY||Odds Ratio (OR)|0.63||||0.718|TWO_SIDED|95.0|0.05|7.48|||Cochran-Mantel-Haenszel|||||7.48|0.05|0.718
71929812|NCT03706209|143380125|SUPERIORITY||Odds Ratio (OR)|2.4||||0.474|TWO_SIDED|95.0|0.21|28.05|||Cochran-Mantel-Haenszel|||||28.05|0.21|0.474
71929813|NCT03706209|143380125|SUPERIORITY||Odds Ratio (OR)|1.25||||0.867|TWO_SIDED|95.0|0.08|19.05|||Cochran-Mantel-Haenszel|||||19.05|0.08|0.867
71929814|NCT03706209|143380126|SUPERIORITY||Odds Ratio (OR)|2.2||||0.375|TWO_SIDED|95.0|0.38|12.84|||Cochran-Mantel-Haenszel|||||12.84|0.38|0.375
71929815|NCT03706209|143380126|SUPERIORITY||Odds Ratio (OR)|4.24||||0.116|TWO_SIDED|95.0|0.66|27.08|||Cochran-Mantel-Haenszel|||||27.08|0.66|0.116
71929816|NCT03706209|143380127|SUPERIORITY||Odds Ratio (OR)|0.41||||0.287|TWO_SIDED|95.0|0.08|2.27|||Cochran-Mantel-Haenszel|||||2.27|0.08|0.287
71929817|NCT03706209|143380127|SUPERIORITY||Odds Ratio (OR)|1.85||||0.332|TWO_SIDED|95.0|0.53|6.4|||Cochran-Mantel-Haenszel|||||6.4|0.53|0.332
71929818|NCT03706209|143380128|SUPERIORITY||Odds Ratio (OR)|0.81||||0.719|TWO_SIDED|95.0|0.25|2.63|||Cochran-Mantel-Haenszel|||||2.63|0.25|0.719
71929819|NCT03706209|143380128|SUPERIORITY||Odds Ratio (OR)|1.72||||0.357|TWO_SIDED|95.0|0.55|5.32|||Cochran-Mantel-Haenszel|||||5.32|0.55|0.357
71929820|NCT03706209|143380129|SUPERIORITY||Odds Ratio (OR)|1.75||||0.355|TWO_SIDED|95.0|0.53|5.72|||Cochran-Mantel-Haenszel|||||5.72|0.53|0.355
71689856|NCT03373461|142896037|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.794|1.214||||||||1.214|0.794|
71689857|NCT03373461|142896037|OTHER||Ratio to placebo (of ratio to baseline)|1.03|||||TWO_SIDED|80.0|0.835|1.269||||||||1.269|0.835|
71929821|NCT03706209|143380129|SUPERIORITY||Odds Ratio (OR)|2.22||||0.198|TWO_SIDED|95.0|0.67|7.37|||Cochran-Mantel-Haenszel|||||7.37|0.67|0.198
71929822|NCT03706209|143380130|SUPERIORITY||least square means|0.3|STANDARD_ERROR_OF_MEAN|1.0||0.757|TWO_SIDED|95.0|-1.7|2.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||2.3|-1.7|0.757
71929823|NCT03706209|143380130|SUPERIORITY||least square means|-1.1|STANDARD_ERROR_OF_MEAN|1.0||0.267|TWO_SIDED|95.0|-3.1|0.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||0.9|-3.1|0.267
71929824|NCT03706209|143380131|SUPERIORITY||least square means|1.0|STANDARD_ERROR_OF_MEAN|1.2||0.412|TWO_SIDED|95.0|-1.4|3.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.4|-1.4|0.412
71929825|NCT03706209|143380131|SUPERIORITY||least square means|-1.0|STANDARD_ERROR_OF_MEAN|1.2||0.401|TWO_SIDED|95.0|-3.5|1.4|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||1.4|-3.5|0.401
71929826|NCT03706209|143380132|SUPERIORITY||least square means|0.4|STANDARD_ERROR_OF_MEAN|1.7||0.801|TWO_SIDED|95.0|-3.0|3.9|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.9|-3|0.801
71929827|NCT03706209|143380132|SUPERIORITY||least square means|0.1|STANDARD_ERROR_OF_MEAN|1.7||0.957|TWO_SIDED|95.0|-3.4|3.3|||ANCOVA|||Estimates and treatment comparison of least square means using an ANCOVA model, with treatment arm and (pooled) analysis center as factors and baseline outcome as covariate.||3.3|-3.4|0.957
71929828|NCT03706209|143380136|SUPERIORITY||Odds Ratio (OR)|1.45||||0.45|TWO_SIDED|95.0|0.55|3.8|||Cochran-Mantel-Haenszel|||||3.8|0.55|0.45
71929829|NCT03706209|143380136|SUPERIORITY||Odds Ratio (OR)|1.97||||0.186|TWO_SIDED|95.0|0.74|5.26|||Cochran-Mantel-Haenszel|||||5.26|0.74|0.186
71929830|NCT03706209|143380137|SUPERIORITY||Odds Ratio (OR)|0.94||||0.884|TWO_SIDED|95.0|0.41|2.18|||Cochran-Mantel-Haenszel|||||2.18|0.41|0.884
71929831|NCT03706209|143380137|SUPERIORITY||Odds Ratio (OR)|1.49||||0.384|TWO_SIDED|95.0|0.61|3.64|||Cochran-Mantel-Haenszel|||||3.64|0.61|0.384
71689858|NCT03373461|142896037|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.616|0.942||||||||0.942|0.616|
71689859|NCT03373461|142896037|OTHER||Ratio to placebo (of ratio to baseline)|0.85|||||TWO_SIDED|80.0|0.704|1.027||||||||1.027|0.704|
71689860|NCT03373461|142896038|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.723|1.172||||||||1.172|0.723|
71689861|NCT03373461|142896038|OTHER||Ratio to placebo (of ratio to baseline)|0.98|||||TWO_SIDED|80.0|0.767|1.249||||||||1.249|0.767|
71689862|NCT03373461|142896038|OTHER||Ratio to placebo (of ratio to baseline)|0.74|||||TWO_SIDED|80.0|0.577|0.937||||||||0.937|0.577|
71689863|NCT03373461|142896038|OTHER||Ratio to placebo (of ratio to baseline)|0.84|||||TWO_SIDED|80.0|0.678|1.052||||||||1.052|0.678|
71689864|NCT03373461|142896047|OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|80.0|0.42|7.472||||||||7.472|0.420|
71689865|NCT03373461|142896047|OTHER||Mean Difference (Final Values)|0.82|||||TWO_SIDED|80.0|-2.747|4.39||||||||4.390|-2.747|
71689866|NCT03373461|142896047|OTHER||Mean Difference (Final Values)|0.26|||||TWO_SIDED|80.0|-2.745|3.262||||||||3.262|-2.745|
71689867|NCT03373461|142896047|OTHER||Mean Difference (Final Values)|1.98|||||TWO_SIDED|80.0|-1.368|5.337||||||||5.337|-1.368|
71689868|NCT03373461|142896048|OTHER||Ratio to placebo (of ratio to baseline)|1.04|||||TWO_SIDED|80.0|0.68|1.579||||||||1.579|0.680|
71689869|NCT03373461|142896048|OTHER||Ratio to placebo (of ratio to baseline)|0.92|||||TWO_SIDED|80.0|0.607|1.39||||||||1.390|0.607|
71689870|NCT03373461|142896048|OTHER||Ratio to placebo (of ratio to baseline)|0.8|||||TWO_SIDED|80.0|0.558|1.153||||||||1.153|0.558|
71929832|NCT03706209|143380138|SUPERIORITY||Odds Ratio (OR)|1.64||||0.311|TWO_SIDED|95.0|0.63|4.26|||Cochran-Mantel-Haenszel|||||4.26|0.63|0.311
71929833|NCT03706209|143380138|SUPERIORITY||Odds Ratio (OR)|1.21||||0.699|TWO_SIDED|95.0|0.47|3.17|||Cochran-Mantel-Haenszel|||||3.17|0.47|0.699
71929834|NCT03706209|143380139|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.671|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.671
71929835|NCT03706209|143380139|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.183|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.183
71929836|NCT03706209|143380140|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.542|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.542
71929837|NCT03706209|143380140|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.328|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.328
71929838|NCT03706209|143380141|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.921|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.921
71929839|NCT03706209|143380141|SUPERIORITY||Hodges-Lehmann using location shift|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.488|TWO_SIDED|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||||0|0|0.488
71929840|NCT03706209|143380152|SUPERIORITY|||||||0.1193|||||||Fisher Exact|||||||0.1193
71929841|NCT03706209|143380152|SUPERIORITY|||||||0.0054|||||||Fisher Exact|||||||0.0054
71929842|NCT03706209|143380153|SUPERIORITY|||||||0.2439|||||||Fisher Exact|||||||0.2439
71929843|NCT03706209|143380153|SUPERIORITY|||||||0.2461|||||||Fisher Exact|||||||0.2461
71929844|NCT03706209|143380154|SUPERIORITY|||||||0.4395|||||||Fisher Exact|||||||0.4395
71929845|NCT03706209|143380154|SUPERIORITY|||||||0.0593|||||||Fisher Exact|||||||0.0593
71929846|NCT03706209|143380156|SUPERIORITY|||||||0.0507|||||||Fisher Exact|||||||0.0507
71929847|NCT03706209|143380156|SUPERIORITY|||||||0.0005|||||||Fisher Exact|||||||0.0005
71929848|NCT03706209|143380157|SUPERIORITY|||||||0.0504|||||||Fisher Exact|||||||0.0504
71929849|NCT03706209|143380157|SUPERIORITY|||||||0.0013|||||||Fisher Exact|||||||0.0013
71929850|NCT03706209|143380158|SUPERIORITY|||||||0.098|||||||Fisher Exact|||||||0.098
71929851|NCT03706209|143380158|SUPERIORITY|||||||0.0032|||||||Fisher Exact|||||||0.0032
71929852|NCT03972709|143380168|SUPERIORITY||Difference in Adjusted Means|0.29|STANDARD_ERROR_OF_MEAN|0.188||0.1206||95.0|-0.08|0.66|||MMRM|||||0.66|-0.08|0.1206
71929853|NCT03972709|143380168|SUPERIORITY||Difference in Adjusted Means|0.12|STANDARD_ERROR_OF_MEAN|0.231||0.6127||95.0|-0.34|0.57|||MMRM|||||0.57|-0.34|0.6127
71929854|NCT03972709|143380175|SUPERIORITY||Difference in Adjusted Means|-0.39|STANDARD_ERROR_OF_MEAN|1.901||0.8388|TWO_SIDED|95.0|-4.14|3.36|||MMRM|||||3.36|-4.14|0.8388
71929855|NCT03972709|143380175|SUPERIORITY||Difference in Adjusted Means|-0.48|STANDARD_ERROR_OF_MEAN|2.384||0.8412|TWO_SIDED|95.0|-5.18|4.23|||MMRM|||||4.23|-5.18|0.8412
71929856|NCT03972709|143380176|SUPERIORITY||Difference in Adjusted Means|0.83|STANDARD_ERROR_OF_MEAN|2.052||0.6865|TWO_SIDED|95.0|-3.22|4.88|||MMRM|||||4.88|-3.22|0.6865
71929857|NCT03972709|143380176|SUPERIORITY||Difference in Adjusted Means|0.2|STANDARD_ERROR_OF_MEAN|2.5||0.9355||95.0|-4.73|5.13|||MMRM|||||5.13|-4.73|0.9355
71929858|NCT00345969|143380178|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||ANOVA|||||||0.01
71929859|NCT00345969|143380179|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||ANOVA|||||||0.55
71929860|NCT00345969|143380180|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||ANOVA|||||||0.23
71929861|NCT00345969|143380181|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||ANOVA|||||||0.43
71929862|NCT00345969|143380182|SUPERIORITY_OR_OTHER|||||||0.33|TWO_SIDED||||||ANOVA|||||||0.33
71929863|NCT00345969|143380183|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||ANOVA|||||||0.93
71929864|NCT00345969|143380184|SUPERIORITY_OR_OTHER|||||||0.24|TWO_SIDED||||||ANOVA|||||||0.24
71929865|NCT00345969|143380185|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||ANOVA|||||||0.49
71929866|NCT00345969|143380186|SUPERIORITY_OR_OTHER|||||||0.19|TWO_SIDED||||||ANOVA|||||||0.19
71929867|NCT00345969|143380187|SUPERIORITY_OR_OTHER|||||||0.71|TWO_SIDED||||||ANOVA|||||||0.71
71929868|NCT00345969|143380188|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||ANOVA|||||||0.44
71929869|NCT00345969|143380189|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||ANOVA|||||||0.89
71929870|NCT00345969|143380190|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||ANOVA|||||||0.13
71929871|NCT02873195|143380191|SUPERIORITY||Hazard Ratio (HR)|0.725||||0.051|TWO_SIDED|95.0|0.491|1.07|||Log Rank|||||1.07|0.491|0.051
71929872|NCT02873195|143380192|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.4|TWO_SIDED|95.0|0.56|1.56|||Log Rank|||||1.56|0.56|0.40
71929873|NCT02873195|143380193|SUPERIORITY|||||||0.4876|||||||Fisher Exact|||||||0.4876
71929874|NCT00752895|143380200|SUPERIORITY_OR_OTHER_LEGACY|||||||0.295|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.295
71929875|NCT00752895|143380201|SUPERIORITY_OR_OTHER_LEGACY|||||||0.82|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression|||||||0.820
71929876|NCT05257109|143380218|OTHER|Mixed effects models with water concentration as the within subject factor and irritation as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Median Difference (Final Values)|0.67||||0.0014|TWO_SIDED|||||Significant p-value set at \<0.05|Mixed Models Analysis|||||||0.0014
71929877|NCT05257109|143380219|OTHER|Mixed effects models with water concentration as the within subject factor and LHS as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|1.55|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71929878|NCT05257109|143380220|OTHER|Mixed effects models with water concentration as the within subject factor and DEQ as outcome. Outcome analyses will be intent-to-treat and using mixed-effects models. If model assumptions will appear to be violated, we will transform the data or fit more flexible generalized linear or nonparametric mixed models. A significant main effect of condition will be considered supportive of our hypothesis. Formal power analyses were not conducted for this pilot study.|Mean Difference (Final Values)|3.28|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<.05
71929879|NCT00915473|143380221|SUPERIORITY_OR_OTHER|||||||0.98|||||||Chi-squared|||||||0.98
71929880|NCT00915473|143380222|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||Severe Migraine Frequency||||0.52
71929881|NCT00915473|143380222|SUPERIORITY_OR_OTHER|||||||0.52|||||||t-test, 2 sided|||At least Moderate Migraine Frequency||||0.52
71929882|NCT00915473|143380222|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||At Least Mild Migraine Frequency||||0.47
71929883|NCT00915473|143380223|SUPERIORITY_OR_OTHER|||||||0.9|||||||t-test, 2 sided|||||||0.90
71929884|NCT00915473|143380224|SUPERIORITY_OR_OTHER|||||||0.47|||||||t-test, 2 sided|||||||0.47
71929885|NCT03443973|143380230|SUPERIORITY||Difference in Adjusted mean|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2998|TWO_SIDED|95.0|-0.55|0.17|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline (BL) + Geographic Region + Disease Stage + AD Medication at BL + Apolipoprotein E, Allele e4 (APOE e4) + Baseline ADAS COG13 + Baseline Alzheimer Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL).||0.17|-0.55|0.2998
71929886|NCT03443973|143380236|SUPERIORITY||Difference in adjusted mean|-1.28|STANDARD_ERROR_OF_MEAN|0.58||0.0273|TWO_SIDED|95.0|-2.41|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4||-0.14|-2.41|0.0273
71929887|NCT03443973|143380237|SUPERIORITY||Difference in adjusted mean|0.82|STANDARD_ERROR_OF_MEAN|0.78||0.2918|TWO_SIDED|95.0|-0.7|2.34|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Region + Disease Stage + AD Medication at BL + APOE e4||2.34|-0.70|0.2918
71689871|NCT03373461|142896048|OTHER||Ratio to placebo (of ratio to baseline)|0.91|||||TWO_SIDED|80.0|0.614|1.362||||||||1.362|0.614|
71689872|NCT03373461|142896050|OTHER||Geometric mean ratio|1.16|||||TWO_SIDED|80.0|0.792|1.692||||||||1.692|0.792|
71689873|NCT03373461|142896050|OTHER||Geometric mean ratio|0.65|||||TWO_SIDED|80.0|0.446|0.945||||||||0.945|0.446|
71929888|NCT03443973|143380238|SUPERIORITY||Difference in adjusted mean|-0.86|STANDARD_ERROR_OF_MEAN|0.43||0.0438|TWO_SIDED|95.0|-1.7|-0.02|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.02|-1.70|0.0438
71929889|NCT03443973|143380239|SUPERIORITY||Difference in adjusted mean|0.52|STANDARD_ERROR_OF_MEAN|0.27||0.0566|TWO_SIDED|95.0|-0.01|1.06|||ANCOVA|||Change from Baseline was calculated based on ANCOVA analysis model which included the following covariates and stratification factors =Treatment + Baseline + Geographic Region + Disease Stage + AD Medication at BL + APOE e4.||1.06|-0.01|0.0566
71929890|NCT03443973|143380240|SUPERIORITY||Difference in adjusted mean|-1.19|STANDARD_ERROR_OF_MEAN|0.53||0.026|TWO_SIDED|95.0|-2.24|-0.14|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||-0.14|-2.24|0.0260
71929891|NCT03443973|143380241|SUPERIORITY||Difference in adjusted mean|-0.03|STANDARD_ERROR_OF_MEAN|0.28||0.9086|TWO_SIDED|95.0|-0.59|0.52|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||0.52|-0.59|0.9086
71929892|NCT03443973|143380242|SUPERIORITY||Difference in adjusted mean|1.41|STANDARD_ERROR_OF_MEAN|0.76||0.0629|TWO_SIDED|95.0|-0.08|2.9|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.90|-0.08|0.0629
71929893|NCT03443973|143380243|SUPERIORITY||Difference in adjusted mean|0.79|STANDARD_ERROR_OF_MEAN|0.66||0.2348|TWO_SIDED|95.0|-0.51|2.09|||ANCOVA|||Change from BL was calculated based on ANCOVA analysis model which included the following covariates and stratification factors = Treatment + Baseline + Geographical Region + Disease Stage + AD Medication at BL + APOE e4.||2.09|-0.51|0.2348
71929894|NCT03443973|143380250|SUPERIORITY||Difference in adjusted means|-56.46|STANDARD_ERROR_OF_MEAN|3.976|<|0.0001|TWO_SIDED|95.0|-64.36|-48.56|||Mixed Model for Repeated Measures|||Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Type of Tracer + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||-48.56|-64.36|<.0001
71929895|NCT03443973|143380251|SUPERIORITY||Difference in adjusted mean|0.01|STANDARD_ERROR_OF_MEAN|0.023||0.7816|TWO_SIDED|95.0|-0.04|0.05|||Mixed Model for Repeated Measures|||Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.04|0.7816
71929896|NCT03443973|143380251|SUPERIORITY||Difference in adjusted means|0.01|STANDARD_ERROR_OF_MEAN|0.018||0.6203|TWO_SIDED|95.0|-0.03|0.05|||Mixed Model for Repeated Measures|||Medial Temporal Composite Region: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.03|0.6203
71929897|NCT03443973|143380251|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.015||0.7754|TWO_SIDED|95.0|-0.03|0.03|||Mixed Model for Repeated Measures|||Frontal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.03|-0.03|0.7754
71929898|NCT03443973|143380251|SUPERIORITY||Difference in adjusted means|0.0|STANDARD_ERROR_OF_MEAN|0.026||0.9022|TWO_SIDED|95.0|-0.05|0.05|||Mixed Model for Repeated Measures|||Parietal Lobe: Change from BL was calculated based on mixed-effect model of repeated measure which included the following covariates and stratification factors = Baseline + APOE e4 status + Study + Analysis Visit + Treatment + Treatment\*Analysis Visit + Analysis Visit\*Baseline.||0.05|-0.05|0.9022
71689874|NCT03373461|142896050|OTHER||Geometric mean ratio|0.72|||||TWO_SIDED|80.0|0.518|0.997||||||||0.997|0.518|
71689875|NCT03373461|142896050|OTHER||Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.558|1.146||||||||1.146|0.558|
71689876|NCT03373461|142896051|OTHER||Ratio to placebo (of ratio to baseline)|1.14|||||TWO_SIDED|80.0|0.765|1.699||||||||1.699|0.765|
71689877|NCT03373461|142896051|OTHER||Ratio to placebo (of ratio to baseline)|0.66|||||TWO_SIDED|80.0|0.446|0.984||||||||0.984|0.446|
71689878|NCT03373461|142896051|OTHER||Ratio to placebo (of ratio to baseline)|0.71|||||TWO_SIDED|80.0|0.501|0.995||||||||0.995|0.501|
71689879|NCT03373461|142896051|OTHER||Ratio to placebo (of ratio to baseline)|0.76|||||TWO_SIDED|80.0|0.52|1.107||||||||1.107|0.520|
71689880|NCT00461097|142896057|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.5||||0.025|TWO_SIDED|95.0|4.3|43.9||No adjustments were made to the p-value.|Barnard's statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of egg white solid was compared using Barnard's statistic with the null hypothesis that there was no difference between treatment groups.||43.9|4.3|0.025
71689881|NCT03442725|142896074|OTHER||Geometric Mean Ratio|1.297|||||TWO_SIDED|90.0|0.6|2.805||||||Analysis of variance (ANOVA) comparison of Cmax for telotristat ethyl between test group versus the control group.||2.805|0.600|
71689882|NCT03442725|142896074|OTHER||Geometric Mean Ratio|1.423|||||TWO_SIDED|90.0|0.901|2.247||||||ANOVA comparison of Cmax for LP-778902 between test group versus the control group.||2.247|0.901|
71689883|NCT03442725|142896075|OTHER|Estimate of the median difference and 90% confidence intervals (CIs) was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7452|TWO_SIDED|90.0|-1.0|0.95|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for telotristat ethyl between test group versus the control group.||0.950|-1.000|0.7452
71689884|NCT03442725|142896075|OTHER|Estimate of the median difference and 90% CIs was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7039|TWO_SIDED|90.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for LP-778902 between test group versus the control group.||1.000|-1.000|0.7039
71929899|NCT03443973|143380252|SUPERIORITY||Percent Difference in Geometric Mean|-13.2||||0.014|TWO_SIDED|95.0|-22.51|-2.87|||ANCOVA|||||-2.87|-22.51|0.014
71929900|NCT03443973|143380253|SUPERIORITY||Percent Difference in Geometric Mean|-14.4|||<|0.001|TWO_SIDED|95.0|-21.88|-6.21|||ANCOVA|||||-6.21|-21.88|<0.001
71929901|NCT03443973|143380254|SUPERIORITY||Percent Difference in Geometric Mean|-17.8|||<|0.001|TWO_SIDED|95.0|-24.92|-10.11|||ANCOVA|||||-10.11|-24.92|<0.001
71929902|NCT03443973|143380255|SUPERIORITY||Percent Difference in Geometric Mean|-21.0|||<|0.001|TWO_SIDED|95.0|-28.29|-12.97|||ANCOVA|||||-12.97|-28.29|<0.001
71929903|NCT00315328|143380258|SUPERIORITY_OR_OTHER|||||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).||||0.96
71929904|NCT00315328|143380259|SUPERIORITY_OR_OTHER|||||||0.78||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.||||0.78
71929905|NCT00315328|143380260|SUPERIORITY_OR_OTHER|||||||0.99||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.||||0.99
71929906|NCT00315328|143380261|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||.04
71929907|NCT00315328|143380261|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero||||0.003
71929908|NCT00315328|143380262|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.||||<0.01
71929909|NCT00315328|143380263|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.||||<0.01
71929910|NCT00315328|143380264|SUPERIORITY_OR_OTHER|||||||0.7||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.||||0.70
71929911|NCT00315328|143380265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||||95.0|-0.03|0.17||||||95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.||0.17|-0.03|
71929912|NCT00315328|143380267|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||||95.0|-0.02|0.18||||||95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.||0.18|-0.02|
71929913|NCT00315328|143380268|NON_INFERIORITY_OR_EQUIVALENCE|Treatment equivalence was to be declared if the ends of the 2 1-sided 95% confidence intervals constructed on the difference between adjusted mean visual acuity scores were completely contained within the designated equivalence interval of +/- 5 letters.|Mean Difference (Net)|1.2||||||95.0|-0.7|3.1|||ANCOVA|||The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.||3.1|-0.7|
71929914|NCT00315328|143380271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.3|||||TWO_SIDED|95.0|0.4|2.2|||ANCOVA|||95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.||2.2|0.4|
71929915|NCT02367729|143380274|SUPERIORITY||Mean Difference (Final Values)|2.15|STANDARD_ERROR_OF_MEAN|0.3947||0.003|TWO_SIDED|95.0|1.37|2.93|||Wilcoxon (Mann-Whitney)|||||2.93|1.37|0.003
71929916|NCT01890109|143380282|SUPERIORITY||Least Square Geometric Mean Ratio|1.1||||0.723|TWO_SIDED|95.0|0.66|1.83|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the number of daily moderate to severe hot flashes. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline number of daily moderate to severe hot flashes was used as a covariate.||1.83|0.66|0.723
71689885|NCT03442725|142896077|OTHER||Geometric Mean Ratio|1.506|||||TWO_SIDED|90.0|0.914|2.48||||||ANOVA comparison of AUC0-inf for LP-778902 between test group versus the control group.||2.480|0.914|
71929917|NCT01890109|143380283|SUPERIORITY||Least Square Geometric Mean Ratio|1.14||||0.551|TWO_SIDED|95.0|0.74|1.74|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the daily hot flash severity score. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline daily hot flash severity score was used as a covariate.||1.74|0.74|0.551
71929918|NCT00996632|143380301|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that drainage volumes are not different||||<0.05
71929919|NCT00996632|143380302|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|||null hypothesis is that Stay in Hospital Days are not different||||0.05
71929920|NCT01598740|143380304|SUPERIORITY_OR_OTHER|||||||0.0662||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.0662
71929921|NCT01598740|143380305|SUPERIORITY_OR_OTHER|||||||0.1899||95.0|||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.||||0.1899
71929922|NCT02861534|143380306|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.269|TWO_SIDED|95.0|0.81|1.06|||Cox proportional hazard model|||||1.06|0.81|0.269
71929923|NCT02861534|143380307|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.048|TWO_SIDED|95.0|0.81|1.0|||Cox proportional hazard model|||||1.00|0.81|0.048
71929924|NCT02861534|143380308|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.019|TWO_SIDED|95.0|0.82|0.98|||Cox proportional hazard model|||||0.98|0.82|0.019
71929925|NCT02861534|143380309|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.023|TWO_SIDED|95.0|0.84|0.99|||Andersen-Gill model|||||0.99|0.84|0.023
71689886|NCT03442725|142896078|OTHER||Geometric Mean Ratio|1.512|||||TWO_SIDED|90.0|0.915|2.498||||||ANOVA comparison of AUC0-tlast for LP-778902 between test group versus the control group.||2.498|0.915|
71689887|NCT03442725|142896082|OTHER||Arithmetic Mean Difference|0.019|||||TWO_SIDED|90.0|-0.03|0.068||||||ANOVA comparison of fu of LP-778902 between test group versus the control group.||0.068|-0.030|
71689888|NCT03442725|142896083|OTHER||Geometric Mean Ratio|1.727|||||TWO_SIDED|90.0|0.866|3.443||||||ANOVA comparison of Cmaxu for LP-778902 between test group versus the control group.||3.443|0.866|
71689889|NCT03442725|142896084|OTHER||Geometric Mean Ratio|1.828|||||TWO_SIDED|90.0|0.903|3.699||||||ANOVA comparison of AUC0-infu for LP-778902 between test group versus the control group.||3.699|0.903|
71689890|NCT03442725|142896085|OTHER||Geometric Mean Ratio|1.835|||||TWO_SIDED|90.0|0.904|3.726||||||ANOVA comparison of AUC0-tlastu for LP-778902 between test group versus the control group.||3.726|0.904|
71689891|NCT03159299|142896103|SUPERIORITY||Mean Difference (Final Values)|0.11|||<|0.15|TWO_SIDED||||||Mixed Models Analysis|||||||<0.15
71689892|NCT02501161|142896127|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
71689893|NCT02501161|142896128|OTHER||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.||||<.0001
71929926|NCT02861534|143380310|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.021|TWO_SIDED|95.0|0.83|0.98|||Cox proportional hazard model|||||0.98|0.83|0.021
71929927|NCT02861534|143380311|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.377|TWO_SIDED|95.0|0.84|1.07|||Cox proportional hazard model|||||1.07|0.84|0.377
71929928|NCT02861534|143380314|OTHER||Difference in Percentage|1.2||||0.121|TWO_SIDED|95.0|-0.3|2.8|||Miettinen & Nurminen method|||||2.8|-0.3|0.121
71929929|NCT02861534|143380315|OTHER||Difference in Percentage|0.6||||0.303|TWO_SIDED|95.0|-0.5|1.6|||Miettinen & Nurminen method|||||1.6|-0.5|0.303
71689894|NCT01990573|142896181|OTHER|ANOVA|F statistic|0.002||||0.002|TWO_SIDED||||||ANOVA|||||||.002
71689895|NCT01990573|142896182|OTHER|ANOVA|F statistic|0.962||||0.962|TWO_SIDED||||||ANOVA|||||||.962
71689896|NCT01000974|142896213|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL.|difference in percentage|-8.59|||||TWO_SIDED|95.0|-12.28|-4.07|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL||-4.07|-12.28|
71689897|NCT01000974|142896213|NON_INFERIORITY|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBVIPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentrations ≥ 0.15 μg/mL.|Difference in percentage|-0.11|||||TWO_SIDED|95.0|-1.98|2.82|||Non-inferiority analysis|||Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL||2.82|-1.98|
71689898|NCT01000974|142896214|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to diphtheria (Anti-D).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.81|||Non-inferiority analysis|||Non-inferiority Anti-D antibody concentrations||1.81|-1.26|
71689899|NCT01000974|142896214|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to tetanus (Anti-T).|Difference in percentage|0.0|||||TWO_SIDED|95.0|-1.26|1.8|||Non-inferiority analysis|||Non-inferiority Anti-T antibody concentrations||1.8|-1.26|
71689900|NCT01000974|142896216|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertussis toxoid \[PT\].|GMC ratio|1.017|||||TWO_SIDED|97.5|0.918|1.127|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PT||1.127|0.918|
71689901|NCT01000974|142896216|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to filamentous hemagglutinin \[FHA\].|GMC ratio|1.088|||||TWO_SIDED|97.5|0.983|1.204|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-FHA||1.204|0.983|
71689902|NCT01000974|142896216|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertactin \[PRN\]|GMC ratio|1.193|||||TWO_SIDED|97.5|1.03|1.382|||Non-inferiority analysis|||Non-inferiority GMC ratio anti-PRN||1.382|1.03|
71689903|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.006|||||TWO_SIDED|97.5|0.873|1.159|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 1 concentrations||1.159|0.873|
71689904|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.048|||||TWO_SIDED|97.5|0.921|1.192|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 3 concentrations||1.192|0.921|
71689905|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.886|1.13|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 4 concentrations||1.13|0.886|
71929930|NCT02780115|143380316|SUPERIORITY||LS Mean Diff|1.96||||0.1663|TWO_SIDED|95.0|-0.83|4.74|||ANCOVA|||||4.74|-0.83|0.1663
71929931|NCT02780115|143380316|SUPERIORITY||LS Mean Diff|4.77||||0.0009|TWO_SIDED|95.0|1.98|7.56|||ANCOVA|||||7.56|1.98|0.0009
71929932|NCT02780115|143380316|SUPERIORITY||LS Mean Diff|4.54||||0.0014|TWO_SIDED|95.0|1.79|7.29|||ANCOVA|||||7.29|1.79|0.0014
71929933|NCT02780115|143380316|SUPERIORITY||LS Mean Diff|4.81||||0.0008|TWO_SIDED|95.0|2.03|7.58|||ANCOVA|||||7.58|2.03|0.0008
71689906|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.02|||||TWO_SIDED|97.5|0.874|1.19|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 5 concentrations||1.19|0.874|
71689907|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.031|||||TWO_SIDED|97.5|0.894|1.188|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6A concentrations||1.188|0.894|
71689908|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.072|||||TWO_SIDED|97.5|0.871|1.32|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 6B concentrations||1.32|0.871|
71689909|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.098|||||TWO_SIDED|97.5|0.964|1.251|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 7F concentrations||1.251|0.964|
71689910|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.035|||||TWO_SIDED|97.5|0.89|1.204|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 9V concentrations||1.204|0.89|
71689911|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.096|||||TWO_SIDED|97.5|0.929|1.294|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 14 concentrations||1.294|0.929|
71929934|NCT02742818|143380342|OTHER|||||||0.19|||||||Generalized Estimation Equations (GEE)|Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.|||Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.|||0.190
71929935|NCT02742818|143380343|OTHER|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||||||0.820
71929936|NCT02742818|143380344|OTHER|||||||0.529|||||||Chi-squared|||||||0.529
71929937|NCT02742818|143380345|OTHER|||||||0.999|||||||Chi-squared|||||||0.999
71929938|NCT02742818|143380346|OTHER|||||||0.462|||||||Wilcoxon (Mann-Whitney)|||||||0.462
71929939|NCT01785472|143380361|NON_INFERIORITY_OR_EQUIVALENCE|The statistical test was made at a one-sided significance level of 0.025.|least Square Means net difference|-2.33|STANDARD_ERROR_OF_MEAN|0.85|<|0.001||95.0|-4.0|-0.66|||ANCOVA|||||-0.66|-4.00|<0.001
71929940|NCT01211873|143380374|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71929941|NCT01211873|143380375|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71689912|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.042|||||TWO_SIDED|97.5|0.9|1.207|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 18C concentrations||1.207|0.9|
71689913|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||TWO_SIDED|97.5|0.859|1.167|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19A concentrations||1.167|0.859|
71689914|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|0.969|||||TWO_SIDED|97.5|0.855|1.098|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 19F concentrations||1.098|0.855|
71689915|NCT01000974|142896217|NON_INFERIORITY|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.031|||||TWO_SIDED|97.5|0.862|1.232|||Non-inferiority analysis|||Non-inferiority Anti-Pneumoniae 23F concentrations||1.232|0.862|
71929942|NCT01211873|143380375|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71929943|NCT01211873|143380376|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71929944|NCT01211873|143380376|SUPERIORITY||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71929945|NCT01294709|143380380|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-6.9|||||TWO_SIDED|90.0|-17.66|3.86|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||3.86|-17.66|
71929946|NCT01294709|143380381|SUPERIORITY_OR_OTHER||Difference in Least squares meand|-0.056|||||TWO_SIDED|90.0|-0.19|0.076|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||0.076|-0.19|
71929947|NCT01294709|143380382|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.14|||||TWO_SIDED|90.0|-22.03|7.74|||mixed effects model|mixed effects model with MK-0974 pooled over doses||Telcagepant minus Placebo Treatment Difference||7.74|-22.03|
71929948|NCT04854707|143380383|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71929949|NCT04854707|143380383|OTHER|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||||||0.032
71689916|NCT01000974|142896218|OTHER|To rule out 10% decrease in seroresponse to FHA in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001|||||||t-test, 1 sided|P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 \& the posterior probability of the cut-off in the control group||Difference in seroresponse Anti-FHA||||<0.0001
71689917|NCT01000974|142896218|OTHER|To rule out 10% decrease in seroresponse to PT in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PT||||<0.0001
71689918|NCT01000974|142896218|OTHER|To rule out 10% decrease in seroresponse to PRN in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn \& HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn \&HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PRN||||<0.0001
71689919|NCT01000974|142896219|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 1.|Difference in percentage|-0.67|||||TWO_SIDED|97.5|-2.24|0.87|||Non-inferiority analysis|||Non-inferiority Anti-Polio 1 concentrations||0.87|-2.24|
71689920|NCT01000974|142896219|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 2.|Difference in percentage|0.45|||||TWO_SIDED|97.5|-1.45|2.91|||Non-inferiority analysis|||Non-inferiority Anti-Polio 2 concentration||2.91|-1.45|
71689921|NCT01000974|142896219|NON_INFERIORITY|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 3.|Difference in percentage|-0.66|||||TWO_SIDED|97.5|-2.2|0.88|||Non-inferiority analysis|||Non-inferiority Anti-Polio 3 concentration||0.88|-2.2|
71929950|NCT04854707|143380384|OTHER||Mean Difference (Final Values)|0.017||||0.314|TWO_SIDED|95.0|-0.0161|0.0501|||Chi-squared|z-value = 1||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0501|-0.0161|0.314
71929951|NCT04854707|143380384|OTHER||Mean Difference (Final Values)|0.0207||||0.482|TWO_SIDED|95.0|-0.0369|0.0782|||Chi-squared|||95% Confidence intervals (CIs) of point estimates were calculated using the exact binominal distribution (Clopper-Pearson method) for proportions||0.0782|-0.0369|0.482
71929952|NCT04854707|143380385|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71929953|NCT04854707|143380385|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71929954|NCT04854707|143380386|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71929955|NCT04854707|143380387|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71929956|NCT04854707|143380387|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71929957|NCT03466060|143380391|SUPERIORITY||Posterior mean difference|-2.1|STANDARD_DEVIATION|2.23|||TWO_SIDED|95.0|-6.4|2.3||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|bayesian multivariate hierarachical||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||2.3|-6.4|
71929958|NCT03466060|143380391|SUPERIORITY||Posertior Mean Difference|-2.5|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.8|1.7||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|5-minute Follow-up Analysis||1.7|-6.8|
71689922|NCT02485483|142896262|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.67|||<|0.001|TWO_SIDED|95.0|0.59|0.74||"Convergent Validity Criterion Correlation coefficient (ρ) \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 221||0.74|0.59|<0.001
71689923|NCT02485483|142896262|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.69|||<|0.001|TWO_SIDED|95.0|0.62|0.76||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 222||0.76|0.62|<0.001
71689924|NCT02485483|142896263|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.58||||0.057|TWO_SIDED|95.0|0.48|0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 203||0.66|0.48|0.057
71929959|NCT03466060|143380391|SUPERIORITY||Posterior Mean Difference|-2.7|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-6.9|1.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian multivariate hierarchical model||Posterior mean difference was calculated as Test-Control.|45-Minute Follolw-up Analysis||1.5|-6.9|
71929960|NCT03466060|143380391|SUPERIORITY||Posterior Mean Difference|-2.5|STANDARD_DEVIATION|2.01|||TWO_SIDED|95.0|-6.5|1.4|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||1.4|-6.5|
71929961|NCT03466060|143380391|SUPERIORITY||Posterior Mean Difference|-1.1|STANDARD_DEVIATION|2.28|||TWO_SIDED|95.0|-5.8|3.1|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis||3.1|-5.8|
71929962|NCT03466060|143380391|SUPERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-0.7|STANDARD_DEVIATION|2.2|||TWO_SIDED|95.0|-5.0|3.6|||Bayesian Multivariate Heirarchical Model||Posterior mean difference was calculated as Test-Control.|5-Minute Follow-up Analysis||3.6|-5.0|
71929963|NCT03466060|143380391|NON_INFERIORITY|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-2.0|STANDARD_DEVIATION|2.16|||TWO_SIDED|95.0|-6.4|2.3|||Bayesian Multivariate Hierarchical Model||Posterior mean difference was calculated as Test-Control.|45-Minute Follow-up Analysis||2.3|-6.4|
71929964|NCT03466060|143380391|SUPERIORITY||Posterior Mean Difference|-1.5|STANDARD_DEVIATION|2.1|||TWO_SIDED|95.0|-5.8|2.5||95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Bayesian Mutlivariate Hiearachical Model||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis||2.5|-5.8|
71929965|NCT01612780|143380394|SUPERIORITY||||||<|0.0001||||||Values of p \<0.05 were deemed statistically significant.|t-test, 2 sided|||Study sample size was established to test the hypothesis that the mean SNOT-20 score is reduced by at least 0.8 points from baseline to 1 year post procedure. Using this delta, a 1-sided alpha of 0.25, and 90% power, a sample size of 19 participants was adequate to test the hypothesis.||||<0.0001
71929966|NCT02964910|143380411|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95% CI of the seroconversion rate difference was not less than -10%.|the seroconversion rate difference(%)|-2.08|||||TWO_SIDED|95.0|-5.23|0.22||||||||0.22|-5.23|
71929967|NCT02964910|143380412|NON_INFERIORITY|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95%CI of the GMC ratio was not lower than 0.5.|GMC ratio|0.69|||||TWO_SIDED|95.0|0.55|0.85||||||||0.85|0.55|
71929968|NCT02964910|143380416|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.778|||||||Chi-squared|||||||0.778
71929969|NCT02964910|143380417|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.728|||||||Chi-squared|||||||0.728
71929970|NCT02964910|143380418|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.949|||||||Chi-squared|||||||0.949
71929971|NCT02964910|143380419|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.614|||||||Chi-squared|||||||0.614
71929972|NCT02964910|143380420|OTHER|The differences in incidence rate of ADR\\AE between the two groups were compared.||||||0.956|||||||Chi-squared|||||||0.956
71929973|NCT04007406|143380421|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold value for statistical significance was p\<0.05|Mixed Models Analysis|||||||<0.0001
71929974|NCT04007406|143380422|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
71929975|NCT04007406|143380423|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
71929976|NCT04007406|143380424|SUPERIORITY||||||<|0.0001|TWO_SIDED|95.0||||The threshold for significance was p \<0.05|Mixed Models Analysis|||||||<0.0001
71929977|NCT04007406|143380425|SUPERIORITY||||||<|0.0001||||||The statistical threshold was p\<0.05|Mixed Models Analysis|||||||<0.0001
71929978|NCT05674721|143380432|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per Food and Drug Administration (FDA) requirements if the 90 percent (%) confidence intervals (CIs) for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|95.13|||||TWO_SIDED|90.0|88.31|102.47||||||||102.47|88.31|
71929979|NCT05674721|143380433|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of Cmax were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.51|||||TWO_SIDED|90.0|93.54|112.35||||||||112.35|93.54|
71929980|NCT05674721|143380434|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.15|||||TWO_SIDED|90.0|96.76|101.61||||||||101.61|96.76|
71929981|NCT05674721|143380435|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-t were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.62|||||TWO_SIDED|90.0|98.15|107.3||||||||107.30|98.15|
71929982|NCT05674721|143380436|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|99.2|||||TWO_SIDED|90.0|96.82|101.63||||||||101.63|96.82|
71929983|NCT05674721|143380437|EQUIVALENCE|The bioequivalence between Treatment A (test) and Treatment B (reference) under fasted conditions would be declared as per FDA if the 90% CIs for the ratio of the geometric means of AUC0-inf were between 80% and 125%.|Ratio of Geometric Least Square Mean|102.73|||||TWO_SIDED|90.0|98.31|107.34||||||||107.34|98.31|
71929984|NCT00091507|143380460|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.28|TWO_SIDED|95.0|0.66|1.13|||Regression, Logistic|||||1.13|0.66|0.28
71929985|NCT00091507|143380461|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.3|1.07|||Regression, Logistic|||||1.07|0.30|0.08
71929986|NCT00091507|143380462|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.24|TWO_SIDED|95.0|0.43|1.23|||Regression, Logistic|||||1.23|0.43|0.24
71929987|NCT00091507|143380463|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72||||0.27|TWO_SIDED|95.0|0.4|1.29|||Regression, Logistic|||||1.29|0.40|0.27
71929988|NCT00091507|143380464|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85|||Regression, Logistic|||||0.85|0.27|0.01
71929989|NCT03506425|143380487|OTHER|||||||0.32|||||||t-test, 2 sided|||||||0.32
71929990|NCT03506425|143380488|OTHER|||||||0.08|||||||ANOVA|||||||0.08
71929991|NCT03506425|143380489|OTHER|||||||0.83|||||||ANOVA|||||||0.83
71929992|NCT02643394|143380492|SUPERIORITY|||||||0.252|TWO_SIDED|80.0|||||Wilcoxon (Mann-Whitney)|||||||0.252
71929993|NCT02643394|143380493|SUPERIORITY|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||||||0.402
71929994|NCT04193033|143380516|SUPERIORITY|||||||0.001|||||||Linear Growth Curve Model|||||||0.001
71929995|NCT04193033|143380517|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71929996|NCT04193033|143380518|SUPERIORITY|||||||0.66|||||||ANOVA|||||||0.66
71929997|NCT04193033|143380520|SUPERIORITY|||||||0.49|||||||Linear Growth Curve Model|Time was included as a fixed effect and both time and intercept were included as random effects.||||||.49
71929998|NCT04193033|143380522|SUPERIORITY|||||||0.06||||||Paired t-test, alpha = .05.|t-test, 2 sided|||||||0.06
71929999|NCT00118209|143380523|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6519|TWO_SIDED|95.0|0.68|1.27|||Log Rank|||||1.27|0.68|0.6519
71930000|NCT00118209|143380524|SUPERIORITY|||||||0.67|||||||t-test, 2 sided|||||||0.67
71930001|NCT00118209|143380525|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.6414|TWO_SIDED|95.0|0.75|1.59|||Log Rank|||||1.59|0.75|0.6414
71930002|NCT00090259|143380532|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.899||||0.027|TWO_SIDED|95.0|0.818|0.988|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.988|0.818|0.027
71930003|NCT00090259|143380533|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.924||||0.068|TWO_SIDED|95.0|0.848|1.006|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.006|0.848|0.068
71930004|NCT00090259|143380534|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.936||||0.235|TWO_SIDED|95.0|0.84|1.044|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||1.044|0.840|0.235
71930005|NCT00090259|143380535|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.865||||0.025|TWO_SIDED|95.0|0.762|0.982|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.982|0.762|0.025
71930006|NCT00090259|143380536|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.892||||0.023|TWO_SIDED|95.0|0.808|0.984|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg|||0.984|0.808|0.023
71930007|NCT00285012|143380559|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.4|||<|0.0001||95.0|4.99|14.14||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Primary endpoint was based on a CO confirmed 4-week CQR (weeks 4 through 12 inclusive). Intent was to evaluate the alternative hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment in subjects with mild to moderate COPD.||14.14|4.99|<0.0001
71930008|NCT00285012|143380560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.88|||<|0.0001||95.0|2.75|8.65||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline versus (vs) placebo at Week 24||8.65|2.75|<0.0001
71930009|NCT00285012|143380560|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.04|||<|0.0001||95.0|2.13|7.67||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.67|2.13|<0.0001
71930010|NCT00285012|143380561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.17|||<|0.0001||95.0|2.96|9.02||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||9.02|2.96|<0.0001
71930011|NCT00285012|143380561|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.92|||<|0.0001||95.0|2.18|7.07||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||7.07|2.18|<0.0001
71930012|NCT00285012|143380562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.99|||<|0.0001||95.0|4.39|11.11||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 12||11.11|4.39|<0.0001
71930013|NCT00285012|143380562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.85|||<|0.0001||95.0|1.79|4.54|||Regression, Logistic|p-value obtained from a logistic regression model including the main effects of treatment and pooled center|odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24||4.54|1.79|<0.0001
71930014|NCT00285012|143380562|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0008||95.0|1.37|3.48||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.48|1.37|0.0008
71930015|NCT00285012|143380563|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.45||||0.0002||95.0|1.52|3.95||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52||3.95|1.52|0.0002
71930016|NCT00285012|143380564|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] pre-bronchodilator||||0.140
71930017|NCT00285012|143380564|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 \[LOCF\] post-bronchodilator||||0.007
71930018|NCT00285012|143380564|SUPERIORITY_OR_OTHER|||||||0.684||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] pre-bronchodilator||||0.684
71930019|NCT00285012|143380564|SUPERIORITY_OR_OTHER|||||||0.901||95.0|||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 \[LOCF\] post-bronchodilator||||0.901
71930020|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Mental State||||0.078
71930021|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.109||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Mental State||||0.109
71930022|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.281||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Mental State||||0.281
71930023|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.581||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Functional State||||0.581
71930024|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Functional State||||0.290
71930025|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Functional State||||0.063
71689925|NCT02485483|142896263|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.74|||<|0.001|TWO_SIDED|95.0|0.67|0.8||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 200||0.80|0.67|<0.001
71689926|NCT02485483|142896264|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.73|||<|0.001|TWO_SIDED|95.0|0.67|0.79||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 258||0.79|0.67|<0.001
71930026|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Respiratory Symptoms||||0.002
71930027|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.081||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Respiratory Symptoms||||0.081
71930028|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Respiratory Symptoms||||0.016
71930029|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Total Score||||0.033
71930030|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.078||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Total Score||||0.078
71930031|NCT00285012|143380565|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Total Score||||0.023
71930032|NCT05004181|143380583|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the GMR was greater than 0.67.|Geometric mean ratio|13.12|||||TWO_SIDED|95.0|11.14|15.45|||||GMRs and 2-sided 95% CIs were based on the analysis of logarithmically transformed neutralizing titers using a linear regression model with terms of age, sex, and group.|||15.45|11.14|
71930033|NCT05004181|143380584|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the difference of percentages was greater than -10%.|Difference in Percentages|-4.55|||||TWO_SIDED|95.0|-10.04|0.83|||||Adjusted difference in percentages were estimated using minimum risk weights and stratified by sex and age group.|||0.83|-10.04|
71930034|NCT05004181|143380586|OTHER||Difference in Percentages|36.73|||||TWO_SIDED|95.0|19.21|51.17|||||Adjusted difference was estimated using the minimum risk weights and stratified by sex and age group.|||51.17|19.21|
71930035|NCT03993288|143380604|NON_INFERIORITY|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean value calculated by the least squares method did not exceed the predetermined boundary of non-inferiority of 5 g/L|Mean Difference (Net)|-0.24||||0.0032|TWO_SIDED|95.0|-4.86|4.38|||ANCOVA|||||4.38|-4.86|0.0032
71930036|NCT01389024|143380618|SUPERIORITY||Incidence rate ratio|0.216||||0.2914|TWO_SIDED|90.0|0.009|1.66|||Poisson Regression||We calculated confidence intervals from exact Poisson regression.|||1.66|.009|0.2914
71930037|NCT00819091|143380622|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001||95.0|-0.7|-0.24|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-0.24|-0.70|< 0.0001
71930038|NCT00819091|143380623|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-6.4|STANDARD_ERROR_OF_MEAN|5.5||0.2406||95.0|-17.2|4.3|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||4.3|-17.2|0.2406
71930039|NCT00819091|143380624|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.466||||0.0065||95.0|1.684|24.825|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||24.825|1.684|0.0065
71930040|NCT00819091|143380625|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.653||||0.2431||95.0|0.515|13.652|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||13.652|0.515|0.2431
71930041|NCT00819091|143380626|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.125||||0.0001||95.0|2.747|9.562|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo||9.562|2.747|0.0001
71930042|NCT00819091|143380627|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.41|||<|0.0001||95.0|-0.585|-0.23|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.230|-0.585|<0.0001
71930043|NCT00819091|143380628|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.0001||95.0|-0.72|-0.276|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.276|-0.720|<0.0001
71689927|NCT02485483|142896265|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|0.71|||<|0.001|TWO_SIDED|95.0|0.64|0.77||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 214||0.77|0.64|<0.001
71689928|NCT02485483|142896266|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.59||||0.034|TWO_SIDED|95.0|-0.67|-0.49||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 222||-0.49|-0.67|0.034
71689929|NCT02485483|142896266|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.61||||0.01|TWO_SIDED|95.0|-0.68|-0.52||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 223||-0.52|-0.68|0.010
71689930|NCT02485483|142896266|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.73|||<|0.001|TWO_SIDED|95.0|-0.78|-0.66||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 222||-0.66|-0.78|<0.001
71689931|NCT02485483|142896267|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.54||||0.219|TWO_SIDED|95.0|-0.63|-0.43||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 202||-0.43|-0.63|0.219
71689932|NCT02485483|142896267|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.68|||<|0.001|TWO_SIDED|95.0|-0.75|-0.6||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 199||-0.60|-0.75|<0.001
71689933|NCT02485483|142896267|SUPERIORITY_OR_OTHER||Spearman correlation coefficient|-0.77|||<|0.001|TWO_SIDED|95.0|-0.82|-0.7||"Convergent Validity Criterion ρ \> \|0.50\|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 205||-0.70|-0.82|<0.001
71689934|NCT02384538|142896284|OTHER||LS Mean Difference|1.52||||0.386|TWO_SIDED|95.0|-1.944|4.99||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||||4.990|-1.944|0.386
71689935|NCT02384538|142896286|OTHER||LS Mean Difference|2.55||||0.383|TWO_SIDED|95.0|-3.214|8.308||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||8.308|-3.214|0.383
71689936|NCT02384538|142896287|OTHER||LS Mean Difference|0.15||||0.719|TWO_SIDED|95.0|-0.677|0.979||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||0.979|-0.677|0.719
71930044|NCT00819091|143380629|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47||||0.0002||95.0|-0.716|-0.226|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo||-0.226|-0.716|0.0002
71930045|NCT00819091|143380630|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-5.9|STANDARD_ERROR_OF_MEAN|4.6||0.197||95.0|-14.9|3.1|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||3.1|-14.9|0.197
71930046|NCT00819091|143380631|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-14.5|STANDARD_ERROR_OF_MEAN|5.6||0.0105||95.0|-25.5|-3.4|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo||-3.4|-25.5|0.0105
71930047|NCT00367679|143380632|SUPERIORITY_OR_OTHER||Percentage of participants with response|5.7||||||95.0|0.7|19.2|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||19.2|0.7|
71930048|NCT00367679|143380633|SUPERIORITY_OR_OTHER||Percentage of participants with response|8.6||||||95.0|1.8|23.1|||||The estimated value given is the percentage of participants who had a response out of the total participants.|||23.1|1.8|
71930049|NCT00367679|143380639|SUPERIORITY_OR_OTHER|||||||0.0028||95.0||||VEGF D|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0028
71930050|NCT00367679|143380639|SUPERIORITY_OR_OTHER|||||||0.0324||95.0||||VEGF A|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0324
71930051|NCT00367679|143380639|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||VEGFR-2|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
71930052|NCT00367679|143380639|SUPERIORITY_OR_OTHER|||||||0.0082||95.0||||c-KIT|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment||||||0.0082
71930053|NCT00367679|143380645|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Vascular endothelial growth factor receptor 2 (VEGFR2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
71930054|NCT00367679|143380645|SUPERIORITY_OR_OTHER||||||<|0.01||95.0||||Placental growth factor (PIGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||<0.01
71930055|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.00024||95.0||||Interferon-inducible cytokine (IP-10)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.00024
71930056|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.0029||95.0||||Cutaneous T-cell attracting chemokine (CTACK)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0029
71930057|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||Stromal cell-derived factor 1 (SDF-1alpha)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0062
71930058|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.0069||95.0||||Monokine induced by interferon gamma (MIG)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0069
71930059|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.0093||95.0||||Tumor necrosis factor ligand (TRAIL)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.0093
71930060|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||Interferon alpha 2 (IFN-alpha2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.021
71930061|NCT00367679|143380645|SUPERIORITY_OR_OTHER|||||||0.326||95.0||||Vascular endothelial growth factor (VEGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment||||||0.326
71930062|NCT02953262|143380646|SUPERIORITY|||||||0.057||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.057
71930063|NCT02953262|143380646|SUPERIORITY|||||||0.753||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.753
71689937|NCT02384538|142896288|OTHER||LS Mean Difference|4.25||||0.387|TWO_SIDED|95.0|-5.448|13.945||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||13.945|-5.448|0.387
71689938|NCT02384538|142896289|OTHER||LS Mean Difference|0.45||||0.281|TWO_SIDED|95.0|-0.373|1.272||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.272|-0.373|0.281
71689939|NCT02384538|142896290|OTHER||LS Mean Difference|0.52||||0.212|TWO_SIDED|95.0|-0.3|1.336||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16||1.336|-0.300|0.212
71689940|NCT02872909|142896291|SUPERIORITY||Mean Difference (Final Values)|1.37|||<|0.05|TWO_SIDED|95.0|0.71|2.54||calculated as \<0.05 for 85% power|t-test, 2 sided|Analysed on log transformed data||Sample size requirement estimation - Preliminary data showed pain scores of 1.25 with ambulatory PDT (n=12) and 5.26 (SD 2.38) for conventional PDT (n=50). Estimated that for 85% power to detect as significant at 5% level a difference in mean pain score in one group of 2cm compared with 4 cm in the other group, assuming two-sided testing, a minimum of 45 subjects needed. We aimed for 50 subjects, with an allocation ratio of 2 (twice as many randomised to ambulatory PDT as conventional PDT)||2.54|0.71|<0.05
71689941|NCT02872909|142896294|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71689942|NCT02256917|142896296|OTHER|Confirmative one-sided one-sample Poisson-test.|ABR|4.87|||||TWO_SIDED|95.0|4.06|5.79||A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|one-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.96-5.93|||5.79|4.06|
71689943|NCT02256917|142896296|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Negative Binomial regression model including a correction for overdispersion.|Rate ratio|11.89|||<|0.0001|TWO_SIDED|95.0|7.5|18.86|||Negative binomial regression model|||||18.86|7.50|<0.0001
71689944|NCT02256917|142896296|OTHER|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Poisson regression model including a correction for overdispersion.|Rate ratio|10.14|||<|0.0001|TWO_SIDED|95.0|6.12|16.8|||Poisson regression model|||||16.80|6.12|<0.0001
71689945|NCT02256917|142896297|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean spontaneous ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|3.12|||||TWO_SIDED|95.0|2.48|3.87|||One-sided one-sample Poisso|||||3.87|2.48|
71689946|NCT02256917|142896298|OTHER|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with 2x/week prophylaxis or less with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|5.03|||||TWO_SIDED|95.0|3.9|6.39|||One-sided one-sample Poisson-test||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.76-6.60|||6.39|3.90|
71689947|NCT00809094|142896312|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.14|TWO_SIDED|95.0|-0.07|0.48|||t-test, 2 sided|||Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)||0.48|-0.07|0.14
71689948|NCT00397189|142896325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.6|STANDARD_DEVIATION|47.0|<|0.05|TWO_SIDED|95.0|-25.3|-6.0|||ANCOVA|||The analysis was a comparison of sleep latency as measured by the sleep diary at Visit 3 in the ITT 65-80 population, using a linear regression model with terms for treatment (Circadin® 2mg vs. Placebo) and baseline sleep latency.||-6|-25.3|<0.05
71689949|NCT01535443|142896327|OTHER|||||||0.374|||||||Traza Pillai|The test was performed with degrees of freedom: 2||||||.374
71689950|NCT02620683|142896339|OTHER||Median Difference (Final Values)|-15.0||||0.006|TWO_SIDED|95.0|-34.6|-5.86|||Wilcoxon (Mann-Whitney)||for a cross over design difference in blood level was calculate buffered lidocaine minus non-buffered lidocaine|The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||-5.86|-34.6|0.006
71689951|NCT02620683|142896340|OTHER||Mean Difference (Final Values)|-0.66||||0.096|TWO_SIDED|95.0|-1.46|0.13|||t-test, 2 sided|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using ProcTTEST (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||0.13|-1.46|0.096
71689952|NCT02620683|142896341|OTHER||Median Difference (Final Values)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P \< 0.05 for all outcomes.||1|-4|0.23
71689953|NCT01806168|142896357|OTHER|||||||0.046|||||||Mixed Models Analysis|||||||0.046
71689954|NCT01806168|142896357|EQUIVALENCE|a \< 0.05||||||0.021|||||||t-test, 2 sided|||||||0.021
71689955|NCT01806168|142896357|EQUIVALENCE|a \< 0.05||||||0.65|||||||t-test, 2 sided|||||||0.65
71689956|NCT01806168|142896358|OTHER|||||||0.93|||||||Mixed Models Analysis|||To test primary and secondary outcomes, we utilized intention to treat data and linear mixed models with a group random effect. Significance was set to a \< 0.05.||||0.93
71689957|NCT01806168|142896359|OTHER|||||||0.18|||||||Mixed Models Analysis|||||||0.18
71689958|NCT01806168|142896360|OTHER|||||||0.54|||||||Mixed Models Analysis|||||||0.54
71689959|NCT01806168|142896361|OTHER|||||||0.86|||||||Mixed Models Analysis|||||||0.86
71689960|NCT01806168|142896362|OTHER|||||||0.4|||||||Mixed Models Analysis|||||||0.4
71930064|NCT02953262|143380646|SUPERIORITY|||||||0.613||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.613
71930065|NCT02953262|143380647|SUPERIORITY|||||||0.308||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.308
71930066|NCT02953262|143380647|SUPERIORITY|||||||0.154||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.154
71930067|NCT02953262|143380647|SUPERIORITY|||||||0.025||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.025
71930068|NCT02953262|143380648|SUPERIORITY|||||||0.102||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.102
71930069|NCT02953262|143380648|SUPERIORITY|||||||0.023||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.023
71689961|NCT01029262|142896367|SUPERIORITY||Risk Ratio (RR)|10.616|||<|0.001|TWO_SIDED|95.0|2.639|42.702|||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group||||42.702|2.639|<0.001
71930070|NCT02953262|143380648|SUPERIORITY|||||||0.439||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.439
71930071|NCT02953262|143380649|SUPERIORITY|||||||0.982||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.982
71930072|NCT02953262|143380649|SUPERIORITY|||||||0.559||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.559
71930073|NCT02953262|143380649|SUPERIORITY|||||||0.032||||||The a priori threshold for statistical significance was p=0.05.|Chi-squared|||||||0.032
71930074|NCT03349437|143380694|SUPERIORITY|||||||0.02||||||This p-value is in reference to the total Modified 6MWT Distance|Wilcoxon Signed Rank|||||||0.02
71930075|NCT01461369|143380695|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.68|STANDARD_ERROR_OF_MEAN|3.806||0.0024|TWO_SIDED|95.0|-19.17|-4.19|||Mixed Models Analysis|||||-4.19|-19.17|0.0024
71930076|NCT01461369|143380695|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.58|STANDARD_ERROR_OF_MEAN|3.739||0.0795|TWO_SIDED|95.0|-13.94|0.78|||Mixed Models Analysis|||||0.78|-13.94|0.0795
71930077|NCT01461369|143380696|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-15.82|STANDARD_ERROR_OF_MEAN|3.552|<|0.0001|TWO_SIDED|95.0|-22.82|-8.83|||Mixed Models Analysis|||||-8.83|-22.82|<0.0001
71930078|NCT01461369|143380696|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.8|STANDARD_ERROR_OF_MEAN|3.481||0.0052|TWO_SIDED|95.0|-16.66|-2.95|||Mixed Models Analysis|||||-2.95|-16.66|0.0052
71930079|NCT01461369|143380697|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.43|STANDARD_ERROR_OF_MEAN|3.776||0.0011|TWO_SIDED|95.0|-19.87|-4.99|||Mixed Models Analysis|||||-4.99|-19.87|0.0011
71930080|NCT01461369|143380697|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.56|STANDARD_ERROR_OF_MEAN|3.707||0.1349|TWO_SIDED|95.0|-12.86|1.74|||Mixed Models Analysis|||||1.74|-12.86|0.1349
71930081|NCT01461369|143380698|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-13.24|STANDARD_ERROR_OF_MEAN|3.377||0.0001|TWO_SIDED|95.0|-19.89|-6.59|||ANCOVA|||||-6.59|-19.89|0.0001
71930082|NCT01461369|143380698|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.48|STANDARD_ERROR_OF_MEAN|3.313||0.0248|TWO_SIDED|95.0|-14.0|-0.96|||ANCOVA|||||-0.96|-14.00|0.0248
71930083|NCT01461369|143380699|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.63|STANDARD_ERROR_OF_MEAN|3.396||0.0002|TWO_SIDED|95.0|-19.32|-5.94|||ANCOVA|||||-5.94|-19.32|0.0002
71930084|NCT01461369|143380699|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.03|STANDARD_ERROR_OF_MEAN|3.339||0.0363|TWO_SIDED|95.0|-13.6|-0.45|||ANCOVA|||||-0.45|-13.60|0.0363
71930085|NCT01461369|143380700|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.38|STANDARD_ERROR_OF_MEAN|3.441||0.0028|TWO_SIDED|95.0|-17.16|-3.6|||ANCOVA|||||-3.60|-17.16|0.0028
71930086|NCT01461369|143380700|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-5.46|STANDARD_ERROR_OF_MEAN|3.385||0.1081|TWO_SIDED|95.0|-12.13|1.21|||ANCOVA|||||1.21|-12.13|0.1081
71930087|NCT04604496|143380703|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|133.17|||||TWO_SIDED|90.0|81.97|216.37||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||216.37|81.97|
71930088|NCT04604496|143380703|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|219.98|||||TWO_SIDED|90.0|135.39|357.41||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||357.41|135.39|
71930089|NCT04604496|143380703|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|334.21|||||TWO_SIDED|90.0|205.7|543.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||543.00|205.70|
71930090|NCT04604496|143380704|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.7|||||TWO_SIDED|90.0|61.33|245.49||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.49|61.33|
71930091|NCT04604496|143380704|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|282.73|||||TWO_SIDED|90.0|141.32|565.66||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||565.66|141.32|
71930092|NCT04604496|143380704|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|640.78|||||TWO_SIDED|90.0|320.27|1282.0||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1282.00|320.27|
71930093|NCT04604496|143380705|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|122.89|||||TWO_SIDED|90.0|61.51|245.51||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||245.51|61.51|
71930094|NCT04604496|143380705|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|283.88|||||TWO_SIDED|90.0|142.1|567.13||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||567.13|142.10|
71930095|NCT04604496|143380705|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|636.32|||||TWO_SIDED|90.0|318.51|1271.24||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||1271.24|318.51|
71930096|NCT04604496|143380706|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|85.19|||||TWO_SIDED|90.0|63.6|114.1||||||Test: the mild hepatic impairment group; Reference: the without hepatic impairment group||114.10|63.60|
71930097|NCT04604496|143380706|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|96.37|||||TWO_SIDED|90.0|71.95|129.07||||||Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group||129.07|71.95|
71930098|NCT04604496|143380706|OTHER|The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.|Ratio of adjusted geometric means|135.2|||||TWO_SIDED|90.0|100.94|181.1||||||Test: the severe hepatic impairment group; Reference: the without hepatic impairment group||181.10|100.94|
71930099|NCT01563029|143380725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.0|||<|0.001|TWO_SIDED|95.0|9.6|22.4|||ANCOVA|Gate-keeper analysis||||22.4|9.6|<0.001
71930100|NCT01563029|143380725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||<|0.001|TWO_SIDED|95.0|5.1|19.8|||ANCOVA||Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.|||19.8|5.1|<0.001
71930101|NCT01563029|143380725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.5|||<|0.001|TWO_SIDED|95.0|12.1|26.9|||ANCOVA||Inference for FF 100 µg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.|||26.9|12.1|<0.001
71930102|NCT01563029|143380725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.6|||<|0.001|TWO_SIDED|95.0|11.3|26.0|||ANCOVA||Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebocomparison.|||26.0|11.3|<0.001
71930103|NCT01563029|143380725|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|14.0|||<|0.001|TWO_SIDED|95.0|6.7|21.4|||ANCOVA|||||21.4|6.7|<0.001
71930104|NCT01563029|143380726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.126|||<|0.001|TWO_SIDED|95.0|0.051|0.201|||ANCOVA|||||0.201|0.051|<0.001
71930105|NCT01563029|143380726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022||||0.551|TWO_SIDED|95.0|-0.05|0.094|||ANCOVA|||||0.094|-0.050|0.551
71930106|NCT01563029|143380726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033||||0.379|TWO_SIDED|95.0|-0.041|0.108|||ANCOVA|||||0.108|-0.041|0.379
71930107|NCT01563029|143380726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.064||||0.089|TWO_SIDED|95.0|-0.01|0.137|||ANCOVA|||||0.137|-0.010|0.089
71930108|NCT01563029|143380727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4||||0.05|TWO_SIDED|95.0|0.0|16.9|||ANCOVA|||||16.9|0.0|0.050
71930109|NCT01563029|143380727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8||||0.023|TWO_SIDED|95.0|1.3|18.2|||ANCOVA|||||18.2|1.3|0.023
71930110|NCT01563029|143380727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.2||||0.004|TWO_SIDED|95.0|3.8|20.5|||ANCOVA|||||20.5|3.8|0.004
71930111|NCT01563029|143380727|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.143|TWO_SIDED|95.0|-2.1|14.6|||ANCOVA|||||14.6|-2.1|0.143
71930112|NCT01563029|143380728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.005|TWO_SIDED|95.0|3.4|19.0|||ANCOVA|||||19.0|3.4|0.005
71930113|NCT01563029|143380728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.4|||<|0.001|TWO_SIDED|95.0|5.7|21.1|||ANCOVA|||||21.1|5.7|<0.001
71930114|NCT01563029|143380728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.4|||<|0.033|TWO_SIDED|95.0|0.7|16.1|||ANCOVA|||||16.1|0.7|<0.033
71930115|NCT01563029|143380728|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.0||||0.042|TWO_SIDED|95.0|0.3|15.7|||ANCOVA|||||15.7|0.3|0.042
71930116|NCT01563029|143380729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.037|TWO_SIDED|95.0|0.7|21.7|||ANCOVA|||||21.7|0.7|0.037
71930117|NCT01563029|143380729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.1||||0.014|TWO_SIDED|95.0|2.6|23.6|||ANCOVA|||||23.6|2.6|0.014
71930118|NCT01563029|143380729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.9||||0.266|TWO_SIDED|95.0|-4.5|16.3|||ANCOVA|||||16.3|-4.5|0.266
71930119|NCT01563029|143380729|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2||||0.242|TWO_SIDED|95.0|-4.2|16.6|||ANCOVA|||||16.6|-4.2|0.242
71930120|NCT01563029|143380730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.6|||<|0.001|TWO_SIDED|95.0|10.0|31.3|||ANCOVA|||||31.3|10.0|<0.001
71930121|NCT01563029|143380730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.9||||0.001|TWO_SIDED|95.0|7.2|28.6|||ANCOVA|||||28.6|7.2|0.001
71930122|NCT01563029|143380730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.5||||0.033|TWO_SIDED|95.0|0.9|22.1|||ANCOVA|||||22.1|0.9|0.033
71930123|NCT01563029|143380730|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.7||||0.002|TWO_SIDED|95.0|6.0|27.3|||ANCOVA|||||27.3|6.0|0.002
71930124|NCT01563029|143380731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.619|TWO_SIDED|95.0|-6.1|10.2|||ANCOVA|||||10.2|-6.1|0.619
71930125|NCT01563029|143380731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.161||95.0|-2.3|13.9|||ANCOVA|||||13.9|-2.3|0.161
71930126|NCT01563029|143380731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.34|TWO_SIDED|95.0|-4.1|12.0|||ANCOVA|||||12.0|-4.1|0.340
71930127|NCT01563029|143380731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.0||||0.459|TWO_SIDED|95.0|-5.0|11.1|||ANCOVA|||||11.1|-5.0|0.459
71930128|NCT01563029|143380732|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71930129|NCT01563029|143380732|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Fisher Exact|||||||0.006
71930130|NCT01563029|143380732|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Fisher Exact|||||||0.003
71930131|NCT01563029|143380732|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71689962|NCT01029262|142896368|SUPERIORITY|||||||1|||||||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.||||||1.000
71930132|NCT02072174|143380748|SUPERIORITY|||||||0.0242|||||||Kruskal-Wallis|||||||0.0242
71930133|NCT02072174|143380749|SUPERIORITY|||||||0.0026|||||||Cochran-Mantel-Haenszel|||patient diary data||||0.0026
71930134|NCT02072174|143380749|SUPERIORITY|||||||0.0127|||||||Cochran-Mantel-Haenszel|||doctor's examination data||||0.0127
71930135|NCT02072174|143380750|SUPERIORITY|||||||0.0394||||||"The p-value associated with treatment factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate. Treatment\*visit interaction p-value is 0.3220."|Mixed Models Analysis|||||||0.0394
71930136|NCT02072174|143380750|SUPERIORITY|||||||0.322||||||"The p-value associated with treatment\*visit interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment\*visit interaction, Day 1 covariate."|Mixed Models Analysis|||||||0.3220
71930137|NCT02072174|143380751|SUPERIORITY|||||||0.0043|||||||Cochran-Mantel-Haenszel|||||||0.0043
71930138|NCT02072174|143380752|SUPERIORITY|||||||0.0104||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 2 (patient diary data)||||0.0104
71930139|NCT02072174|143380752|SUPERIORITY|||||||0.0041||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (patient diary data)||||0.0041
71930140|NCT02072174|143380752|SUPERIORITY|||||||0.0484||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 4 (patient diary data)||||0.0484
71930141|NCT02072174|143380752|SUPERIORITY|||||||0.0603||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (patient diary data)||||0.0603
71930142|NCT02072174|143380752|SUPERIORITY|||||||0.0056||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (doctor's examination)||||0.0056
71930143|NCT02072174|143380752|SUPERIORITY|||||||0.0994||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (doctor's examination)||||0.0994
71930144|NCT02072174|143380753|SUPERIORITY|||||||0.0084|||||||Kruskal-Wallis|||Days 1-7 (patient diary data)||||0.0084
71930145|NCT02072174|143380753|SUPERIORITY|||||||0.0233|||||||Kruskal-Wallis|||Days 1, 3, 5 and 7 (doctor's examination)||||0.0233
71930146|NCT02072174|143380754|SUPERIORITY|||||||0.0721|||||||Mixed Models Analysis|||||||0.0721
71930147|NCT02072174|143380755|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71930148|NCT02072174|143380756|SUPERIORITY|||||||0.3383|||||||Fisher Exact|||||||0.3383
71930149|NCT04466956|143380764|OTHER|Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|||||<|0.01|TWO_SIDED|95.0||||Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.|t-test, 1 sided|||Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.||||<0.01
71930150|NCT00203931|143380765|SUPERIORITY_OR_OTHER|||||||0.11|||||||Log Rank|||||||0.11
71930151|NCT00203931|143380766|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon-Gehan test|||||||0.91
71930152|NCT00203931|143380767|SUPERIORITY_OR_OTHER|||||||0.24|||||||Fisher Exact|||||||0.24
71930153|NCT00203931|143380768|SUPERIORITY_OR_OTHER|||||||0.046|||||||Wilcoxon-Gehan test|||||||0.046
71689963|NCT01029262|142896369|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0|||<|0.001|TWO_SIDED|95.0|0.0||NA for risk ratio is due to 0 responder in placebo group.|P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||||0|< 0.001
71689964|NCT01029262|142896370|SUPERIORITY|||||||0.639|TWO_SIDED||||||Log Rank|p-value from log-rank test to compare lenalidomide and placebo.||||||0.639
71689965|NCT01029262|142896371|SUPERIORITY||Risk Ratio (RR)|1.276||||0.252|TWO_SIDED|95.0|0.867|1.877||p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact|||||1.877|0.867|0.252
71689966|NCT01029262|142896373|SUPERIORITY|||||||0.864|TWO_SIDED|||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.864
71930154|NCT00203931|143380769|SUPERIORITY_OR_OTHER|||||||0.029|||||||Log Rank|||||||0.029
71930155|NCT01393626|143380770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.86||||0.3249|TWO_SIDED|95.0|-7.64|21.36|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||21.36|-7.64|0.3249
71930156|NCT01393626|143380770|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.36||||0.3916|TWO_SIDED|95.0|-8.09|20.8|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo||20.80|-8.09|0.3916
71930157|NCT02426125|143380790|SUPERIORITY||Hazard Ratio (HR)|0.757||||0.0118|TWO_SIDED|95.0|0.607|0.943||Stratified|Log Rank||Stratified|||0.943|0.607|0.0118
71930158|NCT02426125|143380791|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.2461|TWO_SIDED|95.0|0.724|1.086||Stratified|Log Rank||Stratified|||1.086|0.724|0.2461
71930159|NCT02426125|143380794|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.189|TWO_SIDED|95.0|0.473|1.158|||Log Rank|||||1.158|0.473|0.189
71930160|NCT02426125|143380795|SUPERIORITY||Hazard Ratio (HR)|0.879||||0.357|TWO_SIDED|95.0|0.663|1.167||Stratified|Log Rank||Stratified|Global health status/QoL||1.167|0.663|0.357
71930161|NCT03701516|143380862|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-0.38|STANDARD_DEVIATION|1.781|||TWO_SIDED|98.0|-4.53|3.85|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||3.85|-4.53|
71930162|NCT03701516|143380863|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -5.|Posterior Mean Difference|-2.34|STANDARD_DEVIATION|1.263|||TWO_SIDED|98.0|-5.36|0.61|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.61|-5.36|
71689967|NCT01029262|142896374|SUPERIORITY|||||||0.98||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank|||||||0.980
71689968|NCT01029262|142896376|SUPERIORITY|||||||0.823|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Baseline||||0.823
71689969|NCT01029262|142896376|SUPERIORITY|||||||0.371|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 12 (±3 days)||||0.371
71689970|NCT01029262|142896376|SUPERIORITY|||||||0.391|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 24 (±3 days)||||0.391
71689971|NCT01029262|142896376|SUPERIORITY|||||||1|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 36 (±3 days)||||1.000
71689972|NCT01029262|142896376|SUPERIORITY|||||||0.508|TWO_SIDED||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 48 (±3 days)||||0.508
71689973|NCT01029262|142896377|SUPERIORITY|||||||0.323|TWO_SIDED||||||ANOVA|P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.||Week 12||||0.323
71689974|NCT01029262|142896377|SUPERIORITY|||||||0.071|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.071
71689975|NCT01029262|142896378|SUPERIORITY|||||||0.76|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score|ANOVA|||Week 12||||0.760
71689976|NCT01029262|142896378|SUPERIORITY|||||||0.251|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.251
71689977|NCT01029262|142896379|SUPERIORITY|||||||0.424|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.424
71689978|NCT01029262|142896379|SUPERIORITY|||||||0.116|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.116
71689979|NCT01029262|142896380|SUPERIORITY|||||||0.746|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.746
71689980|NCT01029262|142896380|SUPERIORITY|||||||0.46|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||||||0.460
71689981|NCT01029262|142896381|SUPERIORITY|||||||0.265|TWO_SIDED|||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12||||0.265
71930163|NCT03701516|143380864|NON_INFERIORITY|Non-inferiority will be established if the lower bound of the credible interval of the mean difference between Test and Control is greater than -1.|Posterior Mean Difference|-0.06|STANDARD_DEVIATION|0.083|||TWO_SIDED|95.0|-0.22|0.1|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.10|-0.22|
71930164|NCT03701516|143380865|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|0.001|STANDARD_DEVIATION|0.0028|||TWO_SIDED|95.0|-0.005|0.006|||Bayesian repeated measurement random-eff|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.006|-0.005|
71930165|NCT03701516|143380866|NON_INFERIORITY|Non-inferiority will be established if the upper bound of the credible interval of the mean difference between Test and Control is less than 0.05.|Posterior Mean Difference|-0.003|STANDARD_DEVIATION|0.0029|||TWO_SIDED|95.0|-0.009|0.002|||Bayesian repeated measurement model|Results were reported as regression coefficient mean estimates with credible intervals (CrI)|Mean difference was calculated as Test - Control|||0.002|-0.009|
71930166|NCT00609115|143380867|SUPERIORITY||Effect size|0.65||||0.01|TWO_SIDED|97.5|||||ANCOVA|||||||0.010
71930167|NCT00609115|143380867|SUPERIORITY||Effect|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
71930168|NCT00609115|143380868|SUPERIORITY||Effect Size|0.0||||1|TWO_SIDED|95.0||||The reported p-value was calculated.|ANCOVA|||||||1.00
71689982|NCT01029262|142896381|SUPERIORITY|||||||0.047|TWO_SIDED|||||3\]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24||||0.047
71689983|NCT01029262|142896382|SUPERIORITY|||||||0.2909|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.2909
71689984|NCT01029262|142896382|SUPERIORITY|||||||0.0759|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.0759
71689985|NCT01029262|142896383|SUPERIORITY|||||||0.6957|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 12||||0.6957
71930169|NCT00609115|143380868|SUPERIORITY||Effect Size|-0.29||||0.06|TWO_SIDED|95.0|||||ANCOVA|||||||0.06
71930170|NCT00609115|143380869|SUPERIORITY||Effect Size|0.33||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
71930171|NCT00609115|143380869|SUPERIORITY||Effect Size|0.4||||0.17|TWO_SIDED|95.0|||||ANCOVA|||||||0.17
71930172|NCT00609115|143380870|SUPERIORITY||Effect Size|0.05||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
71930173|NCT00609115|143380870|SUPERIORITY||Effect Size|-0.27||||0.83|TWO_SIDED|95.0|||||ANCOVA|||||||0.83
71930174|NCT00609115|143380871|SUPERIORITY||Effect Size|0.25||||0.28|TWO_SIDED|95.0|||||ANCOVA|||||||0.28
71930175|NCT00609115|143380871|SUPERIORITY||Effect Size|0.38||||0.09|TWO_SIDED|95.0|||||ANCOVA|||||||0.09
71930176|NCT00609115|143380872|SUPERIORITY||Effect Size|0.23||||0.18|TWO_SIDED|95.0|||||ANCOVA|||||||0.18
71689986|NCT01029262|142896383|SUPERIORITY|||||||0.1729|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 24||||0.1729
71689987|NCT01029262|142896384|SUPERIORITY|||||||0.3975|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments.||Week 12||||0.3975
71689988|NCT01029262|142896384|SUPERIORITY|||||||0.1714|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.1714
71689989|NCT01029262|142896385|SUPERIORITY|||||||0.6408|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12||||0.6408
71689990|NCT01029262|142896385|SUPERIORITY|||||||0.575|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24||||0.5750
71930177|NCT00609115|143380872|SUPERIORITY||Effect Size|0.37||||0.1|TWO_SIDED|95.0|||||ANCOVA|||||||0.10
71930178|NCT00609115|143380873|SUPERIORITY||Effect Size|0.18||||0.45|TWO_SIDED|95.0|||||ANCOVA|||||||0.45
71930179|NCT00609115|143380873|SUPERIORITY||Effect Size|0.71||||0.003|TWO_SIDED|95.0|||||ANCOVA|||||||0.003
71930180|NCT00609115|143380874|SUPERIORITY||Effect Size|-0.17||||0.47|TWO_SIDED|95.0|||||ANCOVA|||||||0.47
71930181|NCT00609115|143380874|SUPERIORITY||Effect Size|0.77||||0.015|TWO_SIDED|95.0|||||ANCOVA|||||||0.015
71930182|NCT00609115|143380875|SUPERIORITY||Effect Size|0.48||||0.05|TWO_SIDED|95.0|||||ANCOVA|||||||0.05
71930183|NCT00609115|143380875|SUPERIORITY||Effect Size|0.56||||0.002|TWO_SIDED|95.0|||||ANCOVA|||||||0.002
71930184|NCT00609115|143380876|SUPERIORITY||Effect Size|0.26||||0.27|TWO_SIDED|95.0|||||ANCOVA|||||||0.27
71930185|NCT00609115|143380876|SUPERIORITY||Effect Size|0.45||||0.045|TWO_SIDED|95.0|||||ANCOVA|||||||0.045
71930186|NCT03083639|143380877|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUC∞ using analysis of variance (ANOVA) models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90 percent (%) confidence intervals (CIs) for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|1.018|||||TWO_SIDED|90.0|0.969|1.07||||||||1.070|0.969|
71930187|NCT03083639|143380878|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUCt using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|0.993|||||TWO_SIDED|90.0|0.939|1.05||||||||1.050|0.939|
71930188|NCT03083639|143380879|EQUIVALENCE|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of Cmax using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of Cmax central values between esomeprazole capsules and tablets are presented.|Point estimate|0.942|||||TWO_SIDED|90.0|0.88|1.009||||||||1.009|0.880|
71930189|NCT02125734|143380880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.081||||0.0017|TWO_SIDED|95.0|0.031|0.13|||ANCOVA|||||0.130|0.031|0.0017
71689991|NCT01029262|142896386|SUPERIORITY|||||||0.2848|TWO_SIDED||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments||Week 12||||0.2848
71930190|NCT00981019|143380909|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"Study was exploratory, thus no hypotheses had been formalized beforehand.~To analyze repeated measures outcomes (e.g., effect of the four different statistic scenarios on doctors' recommendation of screening, their judgment of screening's effectiveness, etc.), we used the McNemar chi-square test and the Wilcoxon signed-rank test.~To test for order effects (scenarios were randomly presented)Pearson's chi-square test and the Mann-Whitney U test were used."||||<0.05
71930191|NCT03940742|143380933|OTHER||Ratio of geometric least squares mean|1.08|||||TWO_SIDED|90.0|0.879|1.32||||||||1.32|0.879|
71930192|NCT03940742|143380933|OTHER||Ratio of geometric least squares mean|0.96|||||TWO_SIDED|90.0|0.79|1.17||||||||1.17|0.790|
71930193|NCT03940742|143380933|OTHER||Ratio of geometric least squares mean|0.852|||||TWO_SIDED|90.0|0.699|1.04||||||||1.04|0.699|
71930194|NCT03940742|143380934|OTHER||Ratio of geometric least squares mean|0.916|||||TWO_SIDED|90.0|0.726|1.16||||||||1.16|0.726|
71930195|NCT03940742|143380934|OTHER||Ratio of geometric least squares mean|1.0|||||TWO_SIDED|90.0|0.802|1.25||||||||1.25|0.802|
71930196|NCT03940742|143380934|OTHER||Ratio of geometric least squares mean|0.972|||||TWO_SIDED|90.0|0.784|1.21||||||||1.21|0.784|
71930197|NCT02032823|143380935|SUPERIORITY||Hazard Ratio (HR)|0.581||||7.3e-06|TWO_SIDED|99.5|0.409|0.816||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.816|0.409|0.0000073
71930198|NCT02032823|143380936|SUPERIORITY||Hazard Ratio (HR)|0.574||||2.57e-05|TWO_SIDED|99.5|0.392|0.831||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.831|0.392|0.0000257
71930199|NCT02032823|143380937|SUPERIORITY||Hazard Ratio (HR)|0.678||||0.0091|TWO_SIDED|98.5|0.468|0.973||A multiple testing procedure is employed across the primary and all key secondary endpoints to strongly control overall type I error at 5% (2 sided) accounting for all analysis timepoints.|Log Rank|Log rank test is stratified by chemotherapy type, hormone receptor status, and prior platinum therapy using a pre-specified pooling strategy.|Estimate of the treatment hazard ratio is based on a stratified Cox's Proportional Hazards Model, \<1 indicates a lower risk with olaparib compared with placebo arm. Stratification factors are the same as those used in the stratified log-rank test.|||0.973|0.468|0.0091
71930200|NCT03428217|143380943|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.6528|TWO_SIDED|95.0|0.74|1.21|||Log Rank|||Stratified Analysis 1: Stratified by prior programmed cell death protein 1/programmed cell death protein ligand 1 (PD-1/PDL1) inhibitor therapy (yes vs no) and International Metastatic Renal Cell Carcinoma Database (IMDC) prognostic risk group (favorable vs intermediate vs poor).||1.21|0.74|0.6528
71930201|NCT03428217|143380943|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8193|TWO_SIDED|95.0|0.76|1.24|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.24|0.76|0.8193
71930202|NCT03428217|143380943|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.8345|TWO_SIDED|95.0|0.76|1.25|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.25|0.76|0.8345
71930203|NCT03428217|143380943|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9479|TWO_SIDED|95.0|0.78|1.27|||Log Rank|||Unstratified Analysis||1.27|0.78|0.9479
71930204|NCT03428217|143380944|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.3867|TWO_SIDED|95.0|0.83|1.6|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.6|0.83|0.3867
71930205|NCT03428217|143380944|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.3367|TWO_SIDED|95.0|0.85|1.62|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.62|0.85|0.3367
71930206|NCT03428217|143380944|SUPERIORITY||Hazard Ratio (HR)|1.22||||0.2416|TWO_SIDED|95.0|0.88|1.69|||Log Rank|||Stratified Analysis 3: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.69|0.88|0.2416
71930207|NCT03428217|143380944|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.3043|TWO_SIDED|95.0|0.86|1.64|||Log Rank|||Unstratified Analysis||1.64|0.86|0.3043
71930208|NCT03428217|143380945|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9692|TWO_SIDED|95.0|0.79|1.25|||Log Rank|||Stratified Analysis 1: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate vs. poor\].||1.25|0.79|0.9692
71930209|NCT03428217|143380945|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9235|TWO_SIDED|95.0|0.8|1.27|||Log Rank|||Stratified Analysis 2: Stratified by prior PD-1/PD-L1 inhibitor therapy \[yes vs. no\] and IMDC prognostic risk group \[favorable vs. intermediate/poor\].||1.27|0.8|0.9235
71930210|NCT03428217|143380945|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9549|TWO_SIDED|95.0|0.8|1.26|||Log Rank|||Stratified Analysis 3: Stratified by the number of prior anti-angio cancer therapy \[0 vs. \>=1\].||1.26|0.8|0.9549
71930211|NCT03428217|143380945|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.8193|TWO_SIDED|95.0|0.82|1.29|||Log Rank|||Unstratified Analysis||1.29|0.82|0.8193
71930212|NCT03889197|143380946|SUPERIORITY|||||||0.162|||||||Kruskal-Wallis|||||||0.162
71930213|NCT03889197|143380947|SUPERIORITY|||||||0.242|||||||Kruskal-Wallis|||||||0.242
71930214|NCT03889197|143380948|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
71930215|NCT03889197|143380949|SUPERIORITY|||||||0.132|||||||Kruskal-Wallis|||||||0.132
71930216|NCT03889197|143380950|SUPERIORITY|||||||0.445|||||||Kruskal-Wallis|||||||0.445
71930217|NCT03889197|143380951|SUPERIORITY|||||||0.746|||||||Kruskal-Wallis|||||||0.746
71930218|NCT03889197|143380952|SUPERIORITY|||||||0.979|||||||Kruskal-Wallis|||||||0.979
71930219|NCT03889197|143380953|SUPERIORITY|||||||0.289|||||||Chi-squared|||||||0.289
71930220|NCT03889197|143380954|SUPERIORITY|||||||0.94|||||||Kruskal-Wallis|||||||0.940
71930221|NCT03889197|143380955|SUPERIORITY|||||||0.126|||||||Chi-squared|||||||0.126
71930222|NCT03889197|143380956|SUPERIORITY|||||||0.738|||||||Fisher Exact|||||||0.738
71930223|NCT03889197|143380957|SUPERIORITY|||||||0.676|||||||Fisher Exact|||||||0.676
71930224|NCT03889197|143380958|SUPERIORITY|||||||0.996|||||||Kruskal-Wallis|||||||0.996
71930225|NCT03889197|143380959|SUPERIORITY|||||||0.095|||||||Kruskal-Wallis|||||||0.095
71930226|NCT02304302|143381001|SUPERIORITY||Mean Difference (Net)|0.34||||0.61|TWO_SIDED|95.0|-0.98|1.67|||Mixed Models Analysis|||||1.67|-0.98|0.61
71930227|NCT02304302|143381002|SUPERIORITY||Mean Difference (Net)|-0.32||||0.57|TWO_SIDED|95.0|-1.43|0.8|||Mixed Models Analysis|||||0.80|-1.43|0.57
71689992|NCT01029262|142896386|SUPERIORITY|||||||0.1053|TWO_SIDED|||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 1 sided|||Week 24||||0.1053
71930228|NCT02304302|143381003|SUPERIORITY||Median Difference (Net)|-0.04||||0.91|TWO_SIDED|95.0|-0.74|0.66|||Mixed Models Analysis|||||0.66|-0.74|0.91
71930229|NCT02304302|143381004|SUPERIORITY||Median Difference (Final Values)|-0.5||||0.48|TWO_SIDED|95.0|-1.91|0.91|||Mixed Models Analysis|||||0.91|-1.91|0.48
71930230|NCT02304302|143381005|SUPERIORITY||Mean Difference (Net)|-1.31||||0.5|TWO_SIDED|95.0|-5.14|2.53|||Mixed Models Analysis|||||2.53|-5.14|0.50
71930231|NCT02304302|143381006|SUPERIORITY||Mean Difference (Net)|-0.1||||0.62|TWO_SIDED|95.0|-0.52|0.32|||Mixed Models Analysis|||||0.32|-0.52|0.62
71930232|NCT02304302|143381007|SUPERIORITY||Mean Difference (Net)|2.94||||0.84|TWO_SIDED|95.0|-25.32|31.2|||Mixed Models Analysis|||||31.20|-25.32|0.84
71930233|NCT02304302|143381008|SUPERIORITY||Mean Difference (Net)|-3.04||||0.24|TWO_SIDED|95.0|||||ANOVA|||QTc interval duration was the independent variable, treatment and time were the categorical factors.||||0.24
71930234|NCT02304302|143381009|SUPERIORITY||Mean Difference (Net)|1.91||||0.28|TWO_SIDED|95.0|-1.57|5.39|||Mixed Models Analysis|||||5.39|-1.57|0.28
71930235|NCT02304302|143381010|SUPERIORITY||Mean Difference (Net)|0.4||||0.51|TWO_SIDED|95.0|-0.8|1.61|||Mixed Models Analysis|||||1.61|-0.80|0.51
71930236|NCT02304302|143381011|SUPERIORITY||Mean Difference (Net)|1.17||||0.63|TWO_SIDED|95.0|-3.6|5.94|||Mixed Models Analysis|||||5.94|-3.6|0.63
71930237|NCT02304302|143381012|SUPERIORITY||Mean Difference (Net)|-3.65||||0.17|TWO_SIDED|95.0|-8.91|1.61|||Mixed Models Analysis|||||1.61|-8.91|0.17
71930238|NCT03078192|143381050|OTHER|Detecting pre-capillary PH was tested with a cohort of 32 patients. True PH status was based on RHC. A diagnosis of PH was established from mPAP \>20mmHg, while pre-capillary PH required PCWP ≤ 15mmHg and PVR ≥ 3 Woods Units, and post capillary PH required PCWP \> 15mmH and PVR \< 3 Woods Units \[21\]. Patients with both high PVR and PCWP \> 15mmHg were classified as combined pre- and post-capillary PH (CpcPH). Subjects with CpcPH were treated as positive for both pre- and post-capillary PH.|positive predictive value|0.86|||||TWO_SIDED|||||Positive predictive value for Precapillary Pulmonary Hypertension: 86%|calculation of PPV|||||||
71930239|NCT02508649|143381054|SUPERIORITY||Treatment difference|0.55||||0.3015|TWO_SIDED|95.0|-1.34|2.43|||van Elteren test|||The primary endpoint was analyzed using a van Elteren test. The analysis included a test of superiority using a two-sided 5% significance level.||2.43|-1.34|0.3015
71930240|NCT02508649|143381055|SUPERIORITY||Odds Ratio (OR)|1.049||||0.7694|TWO_SIDED|95.0|0.762|1.445|||Regression, Logistic||An odds ratio \< 1 in proportion of subjects dying indicates lower mortality in the selepressin group.|Mortality was analyzed using a logistic regression model with the individual sequential organ failure assessment (SOFA) scores and age as covariates and treatment arm as factor.||1.445|0.762|0.7694
71930241|NCT02508649|143381056|SUPERIORITY||Treatment difference|0.29||||0.8458|TWO_SIDED|95.0|-2.07|2.65|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.65|-2.07|0.8458
71930242|NCT02508649|143381057|SUPERIORITY||Treatment difference|0.49||||0.4124|TWO_SIDED|95.0|-1.22|2.19|||van Elteren test|||This endpoint was analyzed using a van Elteren test. The analysis was a test of superiority using a two-sided 5% significance level.||2.19|-1.22|0.4124
71930243|NCT02508649|143381064|OTHER||Treatment difference|-0.51||||0.2009|TWO_SIDED|95.0|-1.3|0.27|||ANCOVA|||Overall score using a modified version of the SOFA on Day 1||0.27|-1.30|0.2009
71930244|NCT02508649|143381064|OTHER||Treatment difference|0.11||||0.7894|TWO_SIDED|95.0|-0.68|0.9|||ANCOVA|||Overall score using a modified version of the SOFA on Day 3||0.90|-0.68|0.7894
71930245|NCT02508649|143381064|OTHER||Treatment difference|0.55||||0.1888|TWO_SIDED|95.0|-0.27|1.37|||ANCOVA|||Overall score using a modified version of the SOFA on Day 7||1.37|-0.27|0.1888
71930246|NCT02508649|143381064|OTHER||Treatment difference|-0.08||||0.2997|TWO_SIDED|95.0|-0.24|0.07|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 1||0.07|-0.24|0.2997
71930247|NCT02508649|143381064|OTHER||Treatment difference|-0.03||||0.6796|TWO_SIDED|95.0|-0.19|0.12|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 3||0.12|-0.19|0.6796
71930248|NCT02508649|143381064|OTHER||Treatment difference|0.03||||0.7467|TWO_SIDED|95.0|-0.14|0.19|||ANCOVA|||Individual organ (respiratory) score using a modified version of the SOFA on Day 7||0.19|-0.14|0.7467
71930249|NCT02508649|143381064|OTHER||Treatment difference|-0.42||||0.0003|TWO_SIDED|95.0|-0.65|-0.19|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 1||-0.19|-0.65|0.0003
71930250|NCT02508649|143381064|OTHER||Treatment difference|-0.25||||0.0349|TWO_SIDED|95.0|-0.49|-0.02|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 3||-0.02|-0.49|0.0349
71930251|NCT02508649|143381064|OTHER||Treatment difference|-0.14||||0.2787|TWO_SIDED|95.0|-0.39|0.11|||ANCOVA|||Individual organ (cardiovascular) score using a modified version of the SOFA on Day 7||0.11|-0.39|0.2787
71930252|NCT02508649|143381064|OTHER||Treatment difference|-0.05||||0.6476|TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 1||0.16|-0.26|0.6476
71930253|NCT02508649|143381064|OTHER||Treatment difference|0.08||||0.4313|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 3||0.29|-0.13|0.4313
71930254|NCT02508649|143381064|OTHER||Treatment difference|0.17||||0.1334|TWO_SIDED|95.0|-0.05|0.39|||ANCOVA|||Individual organ (renal) score using a modified version of the SOFA on Day 7||0.39|-0.05|0.1334
71930255|NCT02508649|143381064|OTHER||Treatment difference|0.12||||0.2126|TWO_SIDED|95.0|-0.07|0.3|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 1||0.30|-0.07|0.2126
71930256|NCT02508649|143381064|OTHER||Treatment Difference|0.23||||0.0174|TWO_SIDED|95.0|0.04|0.41|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 3||0.41|0.04|0.0174
71930257|NCT02508649|143381064|OTHER||Treatment difference|0.23||||0.0194|TWO_SIDED|95.0|0.04|0.43|||ANCOVA|||Individual organ (coagulation) score using a modified version of the SOFA on Day 7||0.43|0.04|0.0194
71930258|NCT02508649|143381064|OTHER||Treatment difference|-0.15||||0.1284|TWO_SIDED|95.0|-0.35|0.04|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 1||0.04|-0.35|0.1284
71930259|NCT02508649|143381064|OTHER||Treatment difference|-0.05||||0.6542|TWO_SIDED|95.0|-0.25|0.15|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 3||0.15|-0.25|0.6542
71930260|NCT02508649|143381064|OTHER||Treatment difference|0.17||||0.1079|TWO_SIDED|95.0|-0.04|0.38|||ANCOVA|||Individual organ (liver) score using a modified version of the SOFA on Day 7||0.38|-0.04|0.1079
71930261|NCT02508649|143381065|OTHER||Odds Ratio (OR)|1.4||||0.063|TWO_SIDED|95.0|0.98|2.0|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 7||2.00|0.98|0.0630
71930262|NCT02508649|143381065|OTHER||Odds Ratio (OR)|1.28||||0.1875|TWO_SIDED|95.0|0.89|1.86|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ dysfunction up to Day 30||1.86|0.89|0.1875
71930263|NCT02508649|143381065|OTHER||Odds Ratio (OR)|1.14||||0.4382|TWO_SIDED|95.0|0.82|1.58|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 7||1.58|0.82|0.4382
71930264|NCT02508649|143381065|OTHER||Odds Ratio (OR)|1.01||||0.9529|TWO_SIDED|95.0|0.73|1.39|||Regression, Logistic||Odds ratio is equal to Selepressin pooled/Placebo.|Percentage of subjects with new organ failure up to Day 30||1.39|0.73|0.9529
71930265|NCT00417859|143381076|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.||||0.05
71930266|NCT03594175|143381088|SUPERIORITY||Mean difference of proportions, Wald|29.51||||0.003|TWO_SIDED|95.0|10.76|48.26|||2-sample Z test for proportions|||CUSA-081 vs Placebo Dwell Time Up To 90 Min -- FAS||48.26|10.76|0.003
71930267|NCT03594175|143381089|NON_INFERIORITY|Non-inferiority was assessed based on the constructed 95% confidence interval (CI) for the difference in the rate of treatment success between CUSA-081 vs alteplase, with non-inferiority considered as demonstrated if the lower limit of the 95% CI for the difference in rate of success is greater than -10%.|Mean difference of proportions, Wald|-10.31||||0.03|TWO_SIDED|95.0|-19.38|-1.24|||2-sample Z test for proportions|||||-1.24|-19.38|0.030
71930268|NCT03594175|143381090|SUPERIORITY||Mean difference of proportions, Wald|24.13||||0.017|TWO_SIDED|95.0|5.84|42.41|||2-sample Z test for proportions|||||42.41|5.84|0.017
71930269|NCT03594175|143381091|SUPERIORITY||Mean difference of proportions, Wald|41.08|||<|0.001|TWO_SIDED|95.0|21.94|60.21|||2-sample Z test for proportions|||||60.21|21.94|<0.001
71930270|NCT03594175|143381092|SUPERIORITY||Mean difference of proportions, Wald|-10.96||||0.019|TWO_SIDED|95.0|-19.89|-2.04|||2-sample Z test for proportions|||||-2.04|-19.89|0.019
71930271|NCT03594175|143381093|SUPERIORITY||Probability Re-Occlusion Free at Day 30|0.948|||||TWO_SIDED|95.0|0.126|7.121||||||Time to first re-occlusion.||7.121|0.126|
71930272|NCT03594175|143381093|OTHER||Cox Proportional Hazard|0.654|||||TWO_SIDED|95.0|0.337|1.27||||||Time to first re-occlusion.||1.270|0.337|
71930273|NCT03594175|143381093|OTHER||Cox Proportional Hazard|1.448|||||TWO_SIDED|95.0|0.193|10.848||||||Time to first re-occlusion.||10.848|0.193|
71930274|NCT00633217|143381216|NON_INFERIORITY_OR_EQUIVALENCE|If the lower bound of the 95% confidence interval for the mean difference in 2-hour post-dose FEV1 change from baseline fell above -75 mL, then HFA MDI could be deemed non-inferior to DISKUS treatment response.||||||0.021||95.0|||||ANCOVA|||||||0.021
71689993|NCT01029262|142896387|SUPERIORITY|||||||0.042|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.042
71930275|NCT01186744|143381219|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Log Rank|||||||0.0008
71930276|NCT01186744|143381219|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71930277|NCT01186744|143381220|SUPERIORITY_OR_OTHER|||||||0.0027|TWO_SIDED||||||Log Rank|||||||0.0027
71930278|NCT01186744|143381220|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Log Rank|||||||<0.0001
71930279|NCT02547779|143381344|SUPERIORITY||Odds Ratio (OR)|0.95|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71930280|NCT02547779|143381345|SUPERIORITY||Odds Ratio (OR)|0.98|||<|0.05|TWO_SIDED||||||Regression, Logistic|||||||<0.05
71930281|NCT01020773|143381346|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANOVA|||||||>0.05
71930282|NCT02675426|143381347|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.1|||<|0.001|TWO_SIDED|95.0|19.1|37.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||37.0|19.1|<0.001
71930283|NCT02675426|143381347|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.5|||<|0.001|TWO_SIDED|95.0|21.6|39.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.4|21.6|<0.001
71930284|NCT02675426|143381348|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|31.2|||<|0.001|TWO_SIDED|95.0|23.0|39.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.5|23.0|<0.001
71930285|NCT02675426|143381348|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.8|||<|0.001|TWO_SIDED|95.0|22.5|39.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||39.0|22.5|<0.001
71930286|NCT02675426|143381349|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Least Squares (LS) Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.42|-0.94||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.94|-1.42|<0.001
71930287|NCT02675426|143381349|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.32|||<|0.001|TWO_SIDED|95.0|-1.56|-1.08||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-1.08|-1.56|<0.001
71930288|NCT02675426|143381350|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|TWO_SIDED|95.0|-0.43|-0.24||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.24|-0.43|<0.001
71930289|NCT02675426|143381350|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.28|||<|0.001|TWO_SIDED|95.0|-0.38|-0.18||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo|||-0.18|-0.38|<0.001
71930290|NCT02675426|143381351|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.55|||<|0.001|TWO_SIDED|95.0|3.13|5.98||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.98|3.13|<0.001
71930291|NCT02675426|143381351|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.98|||<|0.001|TWO_SIDED|95.0|3.54|6.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.42|3.54|<0.001
71689994|NCT01029262|142896387|SUPERIORITY|||||||0.448|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.448
71689995|NCT01029262|142896388|SUPERIORITY|||||||0.825|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.825
71689996|NCT01029262|142896388|SUPERIORITY|||||||0.568|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.568
71689997|NCT01029262|142896389|SUPERIORITY|||||||0.119|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.119
71689998|NCT01029262|142896389|SUPERIORITY|||||||0.172|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.172
71689999|NCT01029262|142896390|SUPERIORITY|||||||0.792|TWO_SIDED|||||The P-values were calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.792
71930292|NCT02675426|143381352|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|20.8|||<|0.001|TWO_SIDED|95.0|13.6|28.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||28.1|13.6|<0.001
71930293|NCT02675426|143381352|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|18.4|||<|0.001|TWO_SIDED|95.0|11.2|25.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||25.5|11.2|<0.001
71930294|NCT02675426|143381353|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|21.3|||<|0.001|TWO_SIDED|95.0|13.0|29.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||29.5|13.0|<0.001
71930295|NCT02675426|143381353|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|23.0|||<|0.001|TWO_SIDED|95.0|14.7|31.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.3|14.7|<0.001
71930296|NCT02675426|143381354|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-51.01|||<|0.001|TWO_SIDED|95.0|-78.14|-23.87||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.87|-78.14|<0.001
71930297|NCT02675426|143381354|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-50.86|||<|0.001|TWO_SIDED|95.0|-78.19|-23.53||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.53|-78.19|<0.001
71930298|NCT02675426|143381355|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.95|||<|0.001|TWO_SIDED|95.0|3.31|6.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.60|3.31|<0.001
71930299|NCT02675426|143381355|SUPERIORITY|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.78|||<|0.001|TWO_SIDED|95.0|3.12|6.44||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.44|3.12|<0.001
71930300|NCT02675426|143381356|SUPERIORITY||Response Rate Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.0||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||31.0|15.1|<0.001
71930301|NCT02675426|143381356|SUPERIORITY||Response Rate Difference|28.4|||<|0.001|TWO_SIDED|95.0|20.4|36.5||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||36.5|20.4|<0.001
71930302|NCT02675426|143381357|SUPERIORITY||Response Rate Difference|14.9|||<|0.001|TWO_SIDED|95.0|8.7|21.1||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||21.1|8.7|<0.001
71930303|NCT02675426|143381357|SUPERIORITY||Response Rate Difference|20.6|||<|0.001|TWO_SIDED|95.0|14.0|27.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||27.2|14.0|<0.001
71690000|NCT01029262|142896390|SUPERIORITY|||||||0.279|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.279
71690001|NCT01029262|142896391|SUPERIORITY|||||||0.476|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12||||0.476
71690002|NCT01029262|142896391|SUPERIORITY|||||||0.052|TWO_SIDED|||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24||||0.052
71930304|NCT02675426|143381358|SUPERIORITY||Response Rate Difference|13.6|||<|0.001|TWO_SIDED|95.0|7.0|20.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo|||20.2|7.0|<0.001
71930305|NCT02675426|143381358|SUPERIORITY||Response Rate Difference|19.7|||<|0.001|TWO_SIDED|95.0|12.7|26.7||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use|Response Rate Difference = Upadacitinib - Placebo|||26.7|12.7|<0.001
71930306|NCT04662086|143381389|OTHER|||||||0.2||||||A p-value of \<0.05 would be considered statistically significant.|Linear mixed-effects regression model|||A generalized linear mixed effects model with parameterization was utilized to capture the difference in change in viral shedding at day 10 between treatment arms. SARS-CoV2 viral RNA CT values were transformed using a standard Reference curve.||||0.20
71930307|NCT04662086|143381390|OTHER||Hazard Ratio (HR)|0.6||||0.07|TWO_SIDED|95.0|0.34|1.04||A p-value of \<0.05 would be considered statistically significant.|Cox proportional hazards model|Two-sided Cox proportional hazards model adjusted for age, sex, and receipt of baseline receipt of monoclonal antibodies.||A two-sided log rank test at the 0.04999 level of significance for the final analysis required 78 events (i.e., sustained symptom resolution) to provide 80% power to detect a hazard ratio of 1.91. Based on previous outpatient COVID-19 trials at Stanford, assumed placebo and treatment arm median time to symptom resolution of 10 and 5 days, respectively, for a total sample size of 120 patients. Participants with missing data lasting through Day 28 were censored on Day 28.||1.04|0.34|0.07
71930308|NCT04662086|143381392|OTHER||Hazard Ratio (HR)|0.62||||0.05|TWO_SIDED|95.0|0.38|1.01|||Linear mixed-effects regression model|||||1.01|0.38|0.05
71930309|NCT04662086|143381393|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.34|1.01||||||||1.01|0.34|
71930310|NCT04662086|143381394|OTHER|||||||0.21||||||A p-value of \<0.05 would be considered statistically significant.|Fisher Exact|||Difference in incidence of ED visits||||0.21
71930311|NCT01856686|143381396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56593|||||||ANCOVA|||Between-Group Comparison||||0.56593
71930312|NCT01856686|143381396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.44929|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.44929
71930313|NCT01856686|143381396|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81844|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.81844
71930314|NCT01856686|143381397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.71152|||||||ANCOVA|||Between-Group Comparison||||0.71152
71930315|NCT01856686|143381397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
71930316|NCT01856686|143381397|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47616|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.47616
71930317|NCT01856686|143381398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.10036|||||||ANCOVA|||Between-Group Comparison||||0.10036
71930318|NCT01856686|143381398|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0082|||||||Paired t-test|||Within-group changes||||0.00820
71930319|NCT01856686|143381398|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||1.00000
71930320|NCT01856686|143381399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92193|||||||ANCOVA|||Between-Group Comparison||||0.92193
71690003|NCT01029262|142896392|SUPERIORITY||Risk Ratio (RR)|1.759||||0.017|TWO_SIDED|95.0|1.083|2.856||p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|Fisher Exact|||||2.856|1.083|0.017
71690004|NCT03410992|142896396|SUPERIORITY||Odds Ratio (OR)|496.318|||<|0.001|TWO_SIDED|95.0|82.798|2975.086||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2975.086|82.798|<0.001
71930321|NCT01856686|143381399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50704|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.50704
71930322|NCT01856686|143381399|SUPERIORITY_OR_OTHER_LEGACY|||||||0.42314|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.42314
71930323|NCT01856686|143381400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08946|||||||ANCOVA|||Between-Group Comparison||||0.08946
71930324|NCT01856686|143381400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27795
71930325|NCT01856686|143381400|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0109|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.01090
71930326|NCT01856686|143381401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.73209|||||||ANCOVA|||Between-Group Comparison||||0.73209
71930327|NCT01856686|143381401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07965|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07965
71930328|NCT01856686|143381401|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61613|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.61613
71930329|NCT01856686|143381402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.33027|||||||ANCOVA|||Between-Group Comparison||||0.33027
71930330|NCT01856686|143381402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00013|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00013
71930331|NCT01856686|143381402|SUPERIORITY_OR_OTHER_LEGACY|||||||0.28019|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.28019
71930332|NCT01856686|143381403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94449|||||||ANCOVA|||Between-Group Comparison||||0.94449
71930333|NCT01856686|143381403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
71930334|NCT01856686|143381403|SUPERIORITY_OR_OTHER_LEGACY|||||||0.85428|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.85428
71930335|NCT01856686|143381404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.83929|||||||ANCOVA|||Between-Group Comparison||||0.83929
71930336|NCT01856686|143381404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.97213|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.97213
71930337|NCT01856686|143381404|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58323|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.58323
71930338|NCT01856686|143381405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05158|||||||ANCOVA|||Between-Group Comparison||||0.05158
71930339|NCT01856686|143381405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.94574
71930340|NCT01856686|143381405|SUPERIORITY_OR_OTHER_LEGACY|||||||0.09331|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.09331
71930341|NCT01856686|143381406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17383|||||||ANCOVA|||Between-Group Comparison||||0.17383
71930342|NCT01856686|143381406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00092|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00092
71930343|NCT01856686|143381406|SUPERIORITY_OR_OTHER_LEGACY|||||||0.15544|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.15544
71930344|NCT01856686|143381407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39707|||||||ANCOVA|||Between-Group Comparison||||0.39707
71930345|NCT01856686|143381407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.27945|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.27945
71930346|NCT01856686|143381407|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.19739
71930347|NCT01856686|143381408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.50964|||||||ANCOVA|||Between-Group Comparison||||0.50964
71930348|NCT01856686|143381408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0071|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00710
71930349|NCT01856686|143381408|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00595|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00595
71930350|NCT01856686|143381409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.48336|||||||ANCOVA|||Between-Group Comparison||||0.48336
71930351|NCT01856686|143381409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08739
71930352|NCT01856686|143381409|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37046|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.37046
71930353|NCT01856686|143381411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45013|||||||ANCOVA|||Between-Group Comparison||||0.45013
71930354|NCT01856686|143381411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17374|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.17374
71930355|NCT01856686|143381411|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07548|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.07548
71930356|NCT01856686|143381412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23226|||||||ANCOVA|||Between-Group Comparison||||0.23226
71930357|NCT01856686|143381412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08812|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.08812
71930358|NCT01856686|143381412|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00776|||||||Pairedt-test|||Within-group comparisons between the baseline and 3 month data||||0.00776
71930359|NCT01856686|143381413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.90843|||||||ANCOVA|||Between-Group Comparison||||0.90843
71930360|NCT01856686|143381413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00413|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00413
71930361|NCT01856686|143381413|SUPERIORITY_OR_OTHER_LEGACY|||||||0.00775|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data||||0.00775
71930362|NCT02216214|143381477|SUPERIORITY||Least Squares Mean (LSM) Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.33||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.33|-1.05|<0.001
71930363|NCT02216214|143381478|SUPERIORITY||LSM Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-0.82|-0.27||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.27|-0.82|<0.001
71930364|NCT02216214|143381479|SUPERIORITY||LSM Difference|13.68|STANDARD_ERROR_OF_MEAN|4.45||0.002|TWO_SIDED|95.0|4.95|22.42||P-value compares the Mirabegron group to the placebo group.|stratified rank ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||22.42|4.95|0.002
71930365|NCT02216214|143381480|SUPERIORITY||LSM Difference|-5.15|STANDARD_ERROR_OF_MEAN|1.37|<|0.001|TWO_SIDED|95.0|-7.84|-2.46||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-2.46|-7.84|<0.001
71930366|NCT02216214|143381481|SUPERIORITY||LSM Difference|2.72|STANDARD_ERROR_OF_MEAN|1.07||0.011|TWO_SIDED|95.0|0.62|4.83||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||4.83|0.62|0.011
71930367|NCT02216214|143381482|SUPERIORITY||LSM Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.16||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and baseline value as a covariate.||-0.16|-0.46|<0.001
71930368|NCT02216214|143381483|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
71690005|NCT03410992|142896397|SUPERIORITY||Odds Ratio (OR)|657.255|||<|0.001|TWO_SIDED|95.0|105.792|4083.333||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||4083.333|105.792|<0.001
71930369|NCT02216214|143381484|SUPERIORITY||Rate Ratio|0.68|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of urgency incontinence episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group was calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||<0.001
71930370|NCT02216214|143381485|SUPERIORITY||Rate Ratio|0.84||||0.432||||||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||The rate ratio for the number of nocturia episodes reported during 3-day diary prior to each visit between mirabegron total group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as fixed factors and number of valid diary days as the offset variable.||||0.432
71930371|NCT02216214|143381486|SUPERIORITY|||||||0.317||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.317
71930372|NCT02216214|143381487|SUPERIORITY|||||||0.165||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.165
71930373|NCT02216214|143381488|SUPERIORITY||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||<0.001
71930374|NCT02216214|143381489|SUPERIORITY|||||||0.019||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Coping Subscale Score||||0.019
71930375|NCT02216214|143381489|SUPERIORITY|||||||0.01||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Concern Subscale Score||||0.010
71930376|NCT02216214|143381489|SUPERIORITY|||||||0.006||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Sleep Subscale Score||||0.006
71930377|NCT02216214|143381489|SUPERIORITY|||||||0.614||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Social Subscale Score||||0.614
71930378|NCT02216214|143381490|SUPERIORITY|||||||0.002||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.002
71690006|NCT03410992|142896398|SUPERIORITY||Odds Ratio (OR)|220.038|||<|0.001|TWO_SIDED|95.0|28.757|1683.639||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1683.639|28.757|<0.001
71930379|NCT02216214|143381491|SUPERIORITY|||||||0.755||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.755
71930380|NCT02216214|143381492|SUPERIORITY||Rate Ratio|0.8||||0.014|TWO_SIDED|95.0|0.67|0.96||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.96|0.67|0.014
71930381|NCT02216214|143381492|SUPERIORITY||Rate Ratio|0.81||||0.043|TWO_SIDED|95.0|0.66|0.99||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.99|0.66|0.043
71930382|NCT02216214|143381492|SUPERIORITY||Rate Ratio|0.69||||0.002|TWO_SIDED|95.0|0.54|0.87||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (\<75, \>=75 years) and country as factors and number of valid diary days as the offset variable.||0.87|0.54|0.002
71930383|NCT02216214|143381494|SUPERIORITY||Odds Ratio (OR)|1.5||||0.005||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.005
71930384|NCT02216214|143381495|SUPERIORITY||Odds Ratio (OR)|1.775|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||<0.001
71930385|NCT02216214|143381496|SUPERIORITY||Odds Ratio (OR)|1.501||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
71690007|NCT03410992|142896399|SUPERIORITY||Odds Ratio (OR)|224.744|||<|0.001|TWO_SIDED|95.0|30.13|1676.425||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||1676.425|30.130|<0.001
71930386|NCT02216214|143381497|SUPERIORITY||Odds Ratio (OR)|1.39||||0.034||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.034
71930387|NCT02216214|143381497|SUPERIORITY||Odds Ratio (OR)|1.327||||0.07||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.070
71930388|NCT02216214|143381497|SUPERIORITY||Odds Ratio (OR)|1.452||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.012
71690008|NCT03410992|142896400|SUPERIORITY||Odds Ratio (OR)|316.641|||<|0.001|TWO_SIDED|95.0|39.423|2543.254||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||2543.254|39.423|<0.001
71690009|NCT03410992|142896401|SUPERIORITY||Odds Ratio (OR)|34.325|||<|0.001|TWO_SIDED|95.0|14.22|82.856||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||82.856|14.220|<0.001
71690010|NCT03410992|142896402|SUPERIORITY||Odds Ratio (OR)|43.497|||<|0.001|TWO_SIDED|95.0|15.728|120.295||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||120.295|15.728|<0.001
71930389|NCT02216214|143381497|SUPERIORITY||Odds Ratio (OR)|1.116||||0.602||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.602
71930390|NCT02216214|143381498|SUPERIORITY||Odds Ratio (OR)|1.634||||0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.001
71930391|NCT02216214|143381499|SUPERIORITY||Odds Ratio (OR)|1.597||||0.003||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (\<75, \>=75 years), and country as fixed factors and baseline value as a covariate.||||0.003
71930392|NCT02216214|143381501|SUPERIORITY|||||||0.471||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||||||0.471
71930393|NCT00713830|143381503|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.867|-0.621||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (\<8.0, \>=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 570 patients in lixisenatide arm and 285 in placebo arm would provide a power of 99% (or 98%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.||-0.621|-0.867|<0.0001
71930394|NCT00703261|143381599|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||cLDA|||Constrained longitudinal data analysis (cLDA)||||0.006
71930395|NCT00703261|143381599|SUPERIORITY_OR_OTHER|||||||0.277||95.0|||||cLDA|||||||0.277
71930396|NCT00703261|143381599|SUPERIORITY_OR_OTHER||Percent Reduction|4.5||||0.088|TWO_SIDED|90.0|-1.0|9.6|||cLDA|||||9.6|-1.0|0.088
71930397|NCT00703261|143381600|SUPERIORITY_OR_OTHER|||||||0.195||95.0|||||cLDA|||||||0.195
71930398|NCT01215955|143381617|SUPERIORITY_OR_OTHER||LS Mean Difference|0.04|||||TWO_SIDED|95.0|-0.15|0.22|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.22|-0.15|
71930399|NCT01215955|143381617|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06|||||TWO_SIDED|95.0|-0.12|0.24|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||0.24|-0.12|
71930400|NCT01215955|143381618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.128|TWO_SIDED|95.0|0.52|1.09||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.09|0.520|0.128
71930401|NCT01215955|143381618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.625|TWO_SIDED|95.0|0.58|1.39||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.39|0.580|0.625
71930402|NCT01215955|143381618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.162|TWO_SIDED|95.0|0.53|1.11||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.11|0.53|0.162
71930403|NCT01215955|143381618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.723|TWO_SIDED|95.0|0.61|1.4||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Linear|||||1.40|0.61|0.723
71930404|NCT01215955|143381619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.701|TWO_SIDED|95.0|0.52|2.67||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||2.67|0.520|0.701
71930405|NCT01215955|143381619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.249|TWO_SIDED|95.0|0.71|3.7||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||3.70|0.710|0.249
71930406|NCT01215955|143381619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.32||||0.015|TWO_SIDED|95.0|0.13|0.8||P-value is for HbA1c ≤7% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|Included treatment and effects for baseline stratification variables: Baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use.||||0.80|0.13|0.015
71930407|NCT01215955|143381619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.078|TWO_SIDED|95.0|0.17|1.1||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or \>8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|||||1.10|0.17|0.078
71930408|NCT01215955|143381620|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81||||0.014|TWO_SIDED|95.0|0.17|1.46||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||1.46|0.17|0.014
71930409|NCT01215955|143381620|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.5||||0.108|TWO_SIDED|95.0|-1.12|0.11||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.11|-1.12|0.108
71930410|NCT01215955|143381621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.182|TWO_SIDED|95.0|0.57|1.11||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.11|0.57|0.182
71690011|NCT03410992|142896403|SUPERIORITY||Odds Ratio (OR)|60.946|||<|0.001|TWO_SIDED|95.0|20.56|180.669||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haensze (CMH) test with region and prior biologic exposure as stratification variables.||180.669|20.560|<0.001
71690012|NCT03410992|142896404|SUPERIORITY||Odds Ratio (OR)|158.0|||<|0.001|TWO_SIDED|95.0|49.263|506.745||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables.||506.745|49.263|<0.001
71930411|NCT01215955|143381621|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.46|TWO_SIDED|95.0|0.65|1.22||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.||||1.22|0.65|0.460
71930412|NCT01215955|143381622|SUPERIORITY_OR_OTHER||LS Mean Differences|0.29|||||TWO_SIDED|95.0|-0.19|0.77|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||0.77|-0.19|
71930413|NCT01215955|143381622|SUPERIORITY_OR_OTHER||LS Mean Differences|0.81|||||TWO_SIDED|95.0|0.3|1.31|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|||1.31|0.30|
71930414|NCT01215955|143381623|SUPERIORITY_OR_OTHER||LS Mean Differences|0.59||||0.242|TWO_SIDED|95.0|-0.4|1.58||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model.|||1.58|-0.40|0.242
71930415|NCT01215955|143381623|SUPERIORITY_OR_OTHER||LS Mean Differences|1.13||||0.082|TWO_SIDED|95.0|-0.15|2.41||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without 24-week values were handled by the statistical model.|||2.41|-0.15|0.082
71690013|NCT03410992|142896405|SUPERIORITY||Odds Ratio (OR)|45.192|||<|0.001|TWO_SIDED|95.0|18.622|109.672||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||109.672|18.622|<0.001
71690014|NCT03410992|142896405|SUPERIORITY||Odds Ratio (OR)|49.297|||<|0.001|TWO_SIDED|95.0|18.887|128.673||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||128.673|18.887|<0.001
71690015|NCT03410992|142896405|SUPERIORITY||Odds Ratio (OR)|47.406|||<|0.001|TWO_SIDED|95.0|22.087|101.75||P-values for the comparison of treatment groups were based on the CMH test from the general association.|Cochran-Mantel-Haenszel|||Odds ratio: Bimekizumab/Placebo calculated using stratified Cochran-Mantel-Haenszel (CMH) test with region and prior biologic exposure as stratification variables. This statistical analysis is not controlled for multiplicity and is only nominal.||101.750|22.087|<0.001
71690016|NCT03299101|142896441|SUPERIORITY|||||||0.872|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in grip strength across all 4 time points.||||0.872
71690017|NCT03299101|142896441|SUPERIORITY||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|0.71||0.423|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and day of surgery.||||0.423
71690018|NCT03299101|142896441|SUPERIORITY||Mean Difference (Net)|-0.39|STANDARD_ERROR_OF_MEAN|2.12||0.853|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between baseline and 90 days postop.||||0.853
71690019|NCT03299101|142896441|SUPERIORITY||Mean Difference (Net)|-1.28|STANDARD_ERROR_OF_MEAN|2.16||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in grip strength between day of surgery and 90 days postop.||||0.552
71690020|NCT03299101|142896442|SUPERIORITY|||||||0.256||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max MIP across all 4 time points.||||0.256
71930416|NCT01215955|143381624|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.15||||0.723|TWO_SIDED|95.0|-0.95|0.66||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.66|-0.95|0.723
71930417|NCT01215955|143381624|SUPERIORITY_OR_OTHER||LS Mean Differences|-0.28||||0.495|TWO_SIDED|95.0|-1.08|0.52||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model|||0.52|-1.08|0.495
71930418|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|3.32||||0.245|TWO_SIDED|95.0|-2.28|8.93||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||8.93|-2.28|0.245
71930419|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.71||||0.842|TWO_SIDED|95.0|-7.71|6.29||P-value is for Morning 2-HR PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.29|-7.71|0.842
71930420|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|1.42||||0.626||95.0|-4.32|7.16||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.16|-4.32|0.626
71930421|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.48||||0.358|TWO_SIDED|95.0|-10.91|3.95||P-value is for Midday 2-Hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||3.95|-10.91|0.358
71930422|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|3.38||||0.322|TWO_SIDED|95.0|-3.32|10.07||P-value is for Evening Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.07|-3.32|0.322
71930423|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.25||||0.617|TWO_SIDED|95.0|-11.08|6.58||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||6.58|-11.08|0.617
71930424|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|2.37||||0.519|TWO_SIDED|95.0|-4.86|9.6||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||9.60|-4.86|0.519
71930425|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|2.1||||0.415|TWO_SIDED|95.0|-2.96|7.15||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||7.15|-2.96|0.415
71930426|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|4.38||||0.198|TWO_SIDED|95.0|-2.3|11.06||P-value is for Morning 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||11.06|-2.30|0.198
71930427|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|6.22||||0.045|TWO_SIDED|95.0|0.14|12.29||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.29|0.14|0.045
71930428|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|3.07||||0.426|TWO_SIDED|95.0|-4.5|10.64||P-value is for Midday 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||10.64|-4.50|0.426
71930429|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|5.66||||0.14|TWO_SIDED|95.0|-1.86|13.17||P-value is for Evening Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||13.17|-1.86|0.140
71930430|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|11.18||||0.02|TWO_SIDED|95.0|1.74|20.63||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||20.63|1.74|0.020
71930431|NCT01215955|143381625|SUPERIORITY_OR_OTHER||LS Mean Difference|9.01||||0.037|TWO_SIDED|95.0|0.53|17.49||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||17.49|0.53|0.037
71930432|NCT01215955|143381626|SUPERIORITY_OR_OTHER||LS Mean Difference|1.15||||0.543|TWO_SIDED|95.0|-2.55|4.84||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.84|-2.55|0.543
71930433|NCT01215955|143381626|SUPERIORITY_OR_OTHER||LS Mean Difference|6.72||||0.095|TWO_SIDED|95.0|-1.17|14.6||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||14.60|-1.17|0.095
71930434|NCT01215955|143381626|SUPERIORITY_OR_OTHER||LS Mean Difference|8.86||||0.059|TWO_SIDED|95.0|-0.35|18.06||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||18.06|-0.35|0.059
71930435|NCT01215955|143381626|SUPERIORITY_OR_OTHER||LS Mean Difference|1.09||||0.497|TWO_SIDED|95.0|-2.05|4.23||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||4.23|-2.05|0.497
71930436|NCT01215955|143381626|SUPERIORITY_OR_OTHER||LS Mean Difference|5.37||||0.156|TWO_SIDED|95.0|-2.06|12.79||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||12.79|-2.06|0.156
71930437|NCT01215955|143381626|SUPERIORITY_OR_OTHER||LS Mean Difference|6.05||||0.222|TWO_SIDED|95.0|-3.67|15.76||P-value of for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||15.76|-3.67|0.222
71930438|NCT01215955|143381627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.442|TWO_SIDED|95.0|-0.02|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.02|0.442
71930439|NCT01215955|143381627|SUPERIORITY_OR_OTHER||LS Mean Difference|0.07||||0.037|TWO_SIDED|95.0|0.0|0.14||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.14|0.00|0.037
71930440|NCT01215955|143381627|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1|||<|0.001|TWO_SIDED|95.0|0.05|0.16||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.16|0.05|<0.001
71930441|NCT01215955|143381627|SUPERIORITY_OR_OTHER||LS Mean Difference|0.02||||0.275|TWO_SIDED|95.0|-0.01|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference|||||0.05|-0.01|0.275
71930442|NCT01215955|143381627|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03||||0.194|TWO_SIDED|95.0|-0.02|0.08||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.08|-0.02|0.194
71690021|NCT03299101|142896442|SUPERIORITY||Mean Difference (Net)|4.69|STANDARD_ERROR_OF_MEAN|2.78||0.091|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and day of surgery.||||0.091
71690022|NCT03299101|142896442|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.69||0.066|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between baseline and 90 days postop.||||0.066
71690023|NCT03299101|142896442|SUPERIORITY||Mean Difference (Net)|1.86|STANDARD_ERROR_OF_MEAN|3.13||0.552|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MIP between day of surgery and 90 days postop.||||0.552
71690024|NCT03299101|142896443|SUPERIORITY|||||||0.003||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean MIP across all 4 time points.||||0.003
71690025|NCT03299101|142896443|SUPERIORITY||Mean Difference (Net)|7.48|STANDARD_ERROR_OF_MEAN|2.48||0.003|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and day of surgery.||||0.003
71930443|NCT01215955|143381627|SUPERIORITY_OR_OTHER||LS Mean Difference|0.06||||0.245|TWO_SIDED|95.0|-0.04|0.15||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis|||||0.15|-0.04|0.245
71930444|NCT01215955|143381628|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.435
71930445|NCT01215955|143381628|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.351
71930446|NCT01215955|143381629|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.802
71930447|NCT01215955|143381629|SUPERIORITY_OR_OTHER|||||||0.205||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.205
71690026|NCT03299101|142896443|SUPERIORITY||Mean Difference (Net)|10.18|STANDARD_ERROR_OF_MEAN|3.61||0.005|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between baseline and 90 days postop.||||0.005
71690027|NCT03299101|142896443|SUPERIORITY||Mean Difference (Net)|2.31|STANDARD_ERROR_OF_MEAN|2.18||0.29|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MIP between day of surgery and 90 days postop.||||0.290
71690028|NCT03299101|142896444|SUPERIORITY|||||||0.009||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in maximal inspiratory pressure across all 4 time points.||||0.009
71690029|NCT03299101|142896444|SUPERIORITY||Mean Difference (Net)|12.61|STANDARD_ERROR_OF_MEAN|4.57||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and day of surgery.||||0.006
71930448|NCT01215955|143381630|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio of Negative Binomial|1.06||||0.586|TWO_SIDED|95.0|0.86|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial Regression|||||1.30|0.86|0.586
71930449|NCT01215955|143381630|SUPERIORITY_OR_OTHER||Q3D vs Q1D Ratio Negative Binomial|1.05||||0.689|TWO_SIDED|95.0|0.84|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial|||||1.30|0.84|0.689
71930450|NCT01215955|143381631|SUPERIORITY_OR_OTHER|||||||0.258||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.258
71930451|NCT01215955|143381631|SUPERIORITY_OR_OTHER|||||||0.856||95.0||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic|||||||0.856
71930452|NCT00396981|143381632|NON_INFERIORITY_OR_EQUIVALENCE|This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin||||||0.76|||||||Log Rank|||Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)||||0.76
71930453|NCT02494583|143381639|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03918|TWO_SIDED|95.0|0.7|1.02||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.02|0.70|0.03918
71930454|NCT02494583|143381640|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.04611|TWO_SIDED|95.0|0.7|1.03||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.03|0.70|0.04611
71690030|NCT03299101|142896444|SUPERIORITY||Mean Difference (Net)|12.79|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between baseline and 90 days postop.||||0.015
71930455|NCT02494583|143381641|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.15804|TWO_SIDED|95.0|0.62|1.17||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.17|0.62|0.15804
71930456|NCT02494583|143381642|NON_INFERIORITY|Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio (\[HR\], pembro mono arm vs SOC) is \< 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.|Hazard Ratio (HR)|0.91|||||TWO_SIDED|99.2|0.69|1.18|||||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.18|0.69|
71930457|NCT02494583|143381642|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.16205|TWO_SIDED|95.0|0.74|1.1||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||1.10|0.74|0.16205
71930458|NCT02494583|143381643|SUPERIORITY||Hazard Ratio (HR)|0.69||||0.01491|TWO_SIDED|95.0|0.49|0.97||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.||0.97|0.49|0.01491
71930459|NCT02494583|143381644|OTHER||Difference in ORR Percentage|11.5||||0.00447|TWO_SIDED|95.0|2.9|20.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||20.0|2.9|0.00447
71930460|NCT02494583|143381646|OTHER||Difference in ORR Percentage|-22.3|||>|0.99999|TWO_SIDED|95.0|-29.6|-14.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.||-14.9|-29.6|>0.99999
71930461|NCT02494583|143381648|OTHER||Hazard Ratio (HR)|1.64||||1|TWO_SIDED|95.0|1.36|1.98||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.||1.98|1.36|1.00000
71690031|NCT03299101|142896444|SUPERIORITY||Mean Difference (Net)|-0.86|STANDARD_ERROR_OF_MEAN|3.42||0.802|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum MEP between day of surgery and 90 days postop.||||0.802
71690032|NCT03299101|142896445|SUPERIORITY|||||||0.01||||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in Mean MEP across all 4 time points.||||0.010
71930462|NCT02494583|143381649|OTHER||Difference in LS Means|-0.16||||0.948|TWO_SIDED|95.0|-5.01|4.69||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||4.69|-5.01|0.948
71930463|NCT02494583|143381650|OTHER||Difference in LS Means|1.98||||0.368|TWO_SIDED|95.0|-2.34|6.31||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.31|-2.34|0.368
71930464|NCT02494583|143381651|OTHER||Difference in LS Means|2.35||||0.308|TWO_SIDED|95.0|-2.18|6.89||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||6.89|-2.18|0.308
71930465|NCT02494583|143381652|OTHER||Difference in LS Means|-6.56||||0.001|TWO_SIDED|95.0|-10.55|-2.58||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.||-2.58|-10.55|0.001
71930466|NCT01787188|143381655|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.84|STANDARD_ERROR_OF_MEAN|3.097||0.0005|TWO_SIDED|95.0|-16.93|-4.75|||Mixed Models Analysis|||||-4.75|-16.93|0.0005
71930467|NCT01787188|143381655|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.74|STANDARD_ERROR_OF_MEAN|3.154||0.0059|TWO_SIDED|95.0|-14.94|-2.53|||Mixed Models Analysis|||||-2.53|-14.94|0.0059
71930468|NCT01787188|143381656|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.61|STANDARD_ERROR_OF_MEAN|2.641||0.0003|TWO_SIDED|95.0|-14.8|-4.42|||Mixed Models Analysis|||||-4.42|-14.80|0.0003
71930469|NCT01787188|143381656|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-3.9|STANDARD_ERROR_OF_MEAN|2.696||0.1486|TWO_SIDED|95.0|-9.2|1.4|||Mixed Models Analysis|||||1.40|-9.20|0.1486
71930470|NCT01787188|143381657|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.33|STANDARD_ERROR_OF_MEAN|2.865||0.0004|TWO_SIDED|95.0|-15.97|-4.7|||Mixed Models Analysis|||||-4.70|-15.97|0.0004
71930471|NCT01787188|143381657|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.84|STANDARD_ERROR_OF_MEAN|2.917||0.0008|TWO_SIDED|95.0|-15.58|-4.1|||Mixed Models Analysis|||||-4.10|-15.58|0.0008
71930472|NCT01787188|143381658|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.44|STANDARD_ERROR_OF_MEAN|2.521|<|0.0001|TWO_SIDED|95.0|-15.4|-5.48|||ANCOVA|||||-5.48|-15.40|<0.0001
71930473|NCT01787188|143381658|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-7.82|STANDARD_ERROR_OF_MEAN|2.561||0.0024|TWO_SIDED|95.0|-12.85|-2.78|||ANCOVA|||||-2.78|-12.85|0.0024
71930474|NCT01787188|143381659|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.34|STANDARD_ERROR_OF_MEAN|2.623|<|0.0001|TWO_SIDED|95.0|-15.49|-5.18|||Mixed Models Analysis|||||-5.18|-15.49|<0.0001
71930475|NCT01787188|143381659|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.39|STANDARD_ERROR_OF_MEAN|2.662||0.0997|TWO_SIDED|95.0|-9.63|0.84|||Mixed Models Analysis|||||0.84|-9.63|0.0997
71930476|NCT01787188|143381660|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.83|STANDARD_ERROR_OF_MEAN|2.905||0.0008|TWO_SIDED|95.0|-15.54|-4.11|||Mixed Models Analysis|||||-4.11|-15.54|0.0008
71930477|NCT01787188|143381660|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.42|STANDARD_ERROR_OF_MEAN|2.951||0.0015|TWO_SIDED|95.0|-15.22|-3.62|||Mixed Models Analysis|||||-3.62|-15.22|0.0015
71930478|NCT01787188|143381661|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.13|STANDARD_ERROR_OF_MEAN|3.147||0.0014|TWO_SIDED|95.0|-16.32|-3.94|||Mixed Models Analysis|||||-3.94|-16.32|0.0014
71930479|NCT01787188|143381661|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.98|STANDARD_ERROR_OF_MEAN|3.198||0.0019|TWO_SIDED|95.0|-16.27|-3.69|||Mixed Models Analysis|||||-3.69|-16.27|0.0019
71930480|NCT01787188|143381662|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.47|STANDARD_ERROR_OF_MEAN|2.593|<|0.0001|TWO_SIDED|95.0|-15.57|-5.37|||ANCOVA|||||-5.37|-15.57|<0.0001
71930481|NCT01787188|143381662|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.16|STANDARD_ERROR_OF_MEAN|2.627||0.002|TWO_SIDED|95.0|-13.33|-2.99|||ANCOVA|||||-2.99|-13.33|0.0020
71930482|NCT01787188|143381663|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|2.686||0.0001|TWO_SIDED|95.0|-15.73|-5.17|||Mixed Models Analysis|||||-5.17|-15.73|0.0001
71930483|NCT01787188|143381663|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-4.41|STANDARD_ERROR_OF_MEAN|2.725||0.1065|TWO_SIDED|95.0|-9.77|0.95|||Mixed Models Analysis|||||0.95|-9.77|0.1065
71930484|NCT01787188|143381664|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.68|STANDARD_ERROR_OF_MEAN|2.961||0.0012|TWO_SIDED|95.0|-15.5|-3.85|||Mixed Models Analysis|||||-3.85|-15.50|0.0012
71930485|NCT01787188|143381664|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.65|STANDARD_ERROR_OF_MEAN|3.006||0.0014|TWO_SIDED|95.0|-15.56|-3.74|||Mixed Models Analysis|||||-3.74|-15.56|0.0014
71930486|NCT01787188|143381665|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.26|STANDARD_ERROR_OF_MEAN|3.194||0.0014|TWO_SIDED|95.0|-16.54|-3.97|||Mixed Models Analysis|||||-3.97|-16.54|0.0014
71930487|NCT01787188|143381665|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.45|STANDARD_ERROR_OF_MEAN|3.24||0.0014|TWO_SIDED|95.0|-16.82|-4.08|||Mixed Models Analysis|||||-4.08|-16.82|0.0014
71930488|NCT01787188|143381666|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.52|STANDARD_ERROR_OF_MEAN|2.646|<|0.0001|TWO_SIDED|95.0|-15.72|-5.31|||ANCOVA|||||-5.31|-15.72|<0.0001
71930489|NCT01787188|143381666|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.44|STANDARD_ERROR_OF_MEAN|2.68||0.0018|TWO_SIDED|95.0|-13.71|-3.17|||ANCOVA|||||-3.17|-13.71|0.0018
71930490|NCT01787188|143381667|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.98|STANDARD_ERROR_OF_MEAN|2.831||0.0001|TWO_SIDED|95.0|-16.55|-5.41|||Mixed Models Analysis|||||-5.41|-16.55|0.0001
71930491|NCT01787188|143381667|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-6.02|STANDARD_ERROR_OF_MEAN|2.89||0.0379|TWO_SIDED|95.0|-11.71|-0.34|||Mixed Models Analysis|||||-0.34|-11.71|0.0379
71930492|NCT01787188|143381668|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-12.22|STANDARD_ERROR_OF_MEAN|3.152||0.0001|TWO_SIDED|95.0|-18.42|-6.02|||Mixed Models Analysis|||||-6.02|-18.42|0.0001
71930493|NCT01787188|143381668|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.1|STANDARD_ERROR_OF_MEAN|3.21||0.0049|TWO_SIDED|95.0|-15.41|-2.78|||Mixed Models Analysis|||||-2.78|-15.41|0.0049
71930494|NCT01787188|143381669|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-10.94|STANDARD_ERROR_OF_MEAN|3.359||0.0012|TWO_SIDED|95.0|-17.55|-4.33|||Mixed Models Analysis|||||-4.33|-17.55|0.0012
71930495|NCT01787188|143381669|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-9.36|STANDARD_ERROR_OF_MEAN|3.422||0.0066|TWO_SIDED|95.0|-16.09|-2.63|||Mixed Models Analysis|||||-2.63|-16.09|0.0066
71930496|NCT01787188|143381670|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-11.67|STANDARD_ERROR_OF_MEAN|2.751|<|0.0001|TWO_SIDED|95.0|-17.08|-6.26|||ANCOVA|||||-6.26|-17.08|<0.0001
71930497|NCT01787188|143381670|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-8.24|STANDARD_ERROR_OF_MEAN|2.795||0.0034|TWO_SIDED|95.0|-13.74|-2.74|||ANCOVA|||||-2.74|-13.74|0.0034
71930498|NCT02756078|143381679|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|5.0|STANDARD_DEVIATION|1.796|||TWO_SIDED|98.0|1.3|8.73|||Bayesian hierarchical model|A 98% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||8.73|1.30|
71930499|NCT02756078|143381680|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|13.7|STANDARD_DEVIATION|1.701|||TWO_SIDED|95.0|10.34|17.05|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)|||17.05|10.34|
71930500|NCT02756078|143381681|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.37|STANDARD_DEVIATION|0.313|||TWO_SIDED|95.0|-1.0|0.25|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|||Mean difference was calculated as senofilcon A minus samfilcon A.|0.25|-1.00|
71930501|NCT02756078|143381682|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.06|STANDARD_DEVIATION|0.107|||TWO_SIDED|95.0|-0.27|0.16|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.16|-0.27|
71930502|NCT02756078|143381683|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|0.05|STANDARD_DEVIATION|0.261|||TWO_SIDED|95.0|-0.47|0.57|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A|||0.57|-0.47|
71930503|NCT02756078|143381684|NON_INFERIORITY|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.05|STANDARD_DEVIATION|0.159|||TWO_SIDED|95.0|-0.36|0.26|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Mean difference was calculated as senofilcon A minus samfilcon A.|||0.26|-0.36|
71930504|NCT02756078|143381685|NON_INFERIORITY|A non-inferiority margin of 0.67 was used.|Posterior odds ratio|1.35|STANDARD_DEVIATION|0.203|||TWO_SIDED|95.0|0.99|1.79|||Bayesian multinomial model|A 95% credible interval for the posterior odds ratio was used to demonstrate non-inferiority between the senofilcon A and samfilcon A lenses.|Odds ratio was calculated as senofilcon A over samfilcon A.|||1.79|0.99|
71930505|NCT02587117|143381728|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.004
71930506|NCT02587117|143381729|SUPERIORITY_OR_OTHER|||||||0.224|TWO_SIDED|95.0|||||Mann Whitney test|||||||0.224
71930507|NCT03332212|143381776|OTHER||Mean Difference (Final Values)|-0.247|STANDARD_ERROR_OF_MEAN|0.164||0.1418|TWO_SIDED|95.0|-0.582|0.087|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.087|-0.582|0.1418
71930508|NCT03332212|143381776|OTHER||Mean Difference (Final Values)|-0.159|STANDARD_ERROR_OF_MEAN|0.213||0.465|TWO_SIDED|95.0|-0.604|0.286|||ANOVA|||ANOVA on the PCr/ATP ratio absolute change using treatment (empagliflozin vs. placebo), history of diabetes (yes vs, no) and history of atrial fibrillation (yes vs no) as between subjects factor.||0.286|-0.604|0.4650
71930509|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|0.79||||0.069|TWO_SIDED|95.0|-0.06|1.65||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.|||1.65|-0.06|0.069
71930510|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|0.37||||0.43|TWO_SIDED|95.0|-0.55|1.29||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.|||1.29|-0.55|0.43
71930511|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.76|TWO_SIDED|95.0|-1.05|0.77||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.|||0.77|-1.05|0.76
71930512|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|-0.37||||0.41|TWO_SIDED|95.0|-1.27|0.53||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.|||0.53|-1.27|0.41
71930513|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|-0.95||||0.039|TWO_SIDED|95.0|-1.85|-0.05||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.|||-0.05|-1.85|0.039
71930514|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.15|TWO_SIDED|95.0|-1.65|0.26||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.|||0.26|-1.65|0.15
71930515|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.15|TWO_SIDED|95.0|-1.68|0.25||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.|||0.25|-1.68|0.15
71930516|NCT02058368|143381777|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.004|TWO_SIDED|95.0|-2.4|-0.46||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.|||-0.46|-2.40|0.004
71930517|NCT02058368|143381778|SUPERIORITY||Mean Difference (Final Values)|-23.0|STANDARD_ERROR_OF_MEAN|1.48|<|0.001|TWO_SIDED|95.0|-25.9|-20.1||Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.|||-20.1|-25.9|<.001
71930518|NCT02058368|143381778|SUPERIORITY|Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|Mean Difference (Final Values)|-28.4|STANDARD_ERROR_OF_MEAN|1.65|<|0.001|TWO_SIDED|95.0|-31.7|-25.2|||General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24|||-25.2|-31.7|<.001
71930519|NCT02058368|143381779|SUPERIORITY|||||||0.91||||||P-value for IPSS improvement \>= 3 units has been presented for Month 3|Mantel Haenszel|||||||0.91
71930520|NCT02058368|143381779|SUPERIORITY|||||||0.31||||||P-value for IPSS improvement \>= 2 units has been presented for Month 3|Mantel Haenszel|||||||0.31
71930521|NCT02058368|143381779|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 3|Mantel Haenszel|||||||0.42
71930522|NCT02058368|143381779|SUPERIORITY|||||||0.92||||||P-value for IPSS improvement \>= 3 units has been presented for Month 6|Mantel Haenszel|||||||0.92
71930523|NCT02058368|143381779|SUPERIORITY|||||||0.89||||||P-value for IPSS improvement \>= 2 units has been presented for Month 6|Mantel Haenszel|||||||0.89
71930524|NCT02058368|143381779|SUPERIORITY|||||||0.81||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 6|Mantel Haenszel|||||||0.81
71930525|NCT02058368|143381779|SUPERIORITY|||||||0.08||||||P-value for IPSS improvement \>= 3 units has been presented for Month 9|Mantel Haenszel|||||||0.080
71930526|NCT02058368|143381779|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 9|Mantel Haenszel|||||||0.42
71930527|NCT02058368|143381779|SUPERIORITY|||||||0.06||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 9|Mantel Haenszel|||||||0.060
71930528|NCT02058368|143381779|SUPERIORITY|||||||0.14||||||P-value for IPSS improvement \>= 3 units has been presented for Month 12|Mantel Haenszel|||||||0.14
71930529|NCT02058368|143381779|SUPERIORITY|||||||0.26||||||P-value for IPSS improvement \>= 2 units has been presented for Month 12|Mantel Haenszel|||||||0.26
71930530|NCT02058368|143381779|SUPERIORITY|||||||0.048||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 12|Mantel Haenszel|||||||0.048
71930531|NCT02058368|143381779|SUPERIORITY|||||||0.17||||||P-value for IPSS improvement \>= 3 units has been presented for Month 15|Mantel Haenszel|||||||0.17
71930532|NCT02058368|143381779|SUPERIORITY|||||||0.11||||||P-value for IPSS improvement \>= 2 units has been presented for Month 15|Mantel Haenszel|||||||0.11
71930533|NCT02058368|143381779|SUPERIORITY|||||||0.022||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 15|Mantel Haenszel|||||||0.022
71930534|NCT02058368|143381779|SUPERIORITY|||||||0.18||||||P-value for IPSS improvement \>= 3 units has been presented for Month 18|Mantel Haenszel|||||||0.18
71930535|NCT02058368|143381779|SUPERIORITY|||||||0.19||||||P-value for IPSS improvement \>= 2 units has been presented for Month 18|Mantel Haenszel|||||||0.19
71930536|NCT02058368|143381779|SUPERIORITY|||||||0.28||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 18|Mantel Haenszel|||||||0.28
71930537|NCT02058368|143381779|SUPERIORITY|||||||0.39||||||P-value for IPSS improvement \>= 3 units has been presented for Month 21|Mantel Haenszel|||||||0.39
71690033|NCT03299101|142896445|SUPERIORITY||Mean Difference (Net)|12.37|STANDARD_ERROR_OF_MEAN|4.35||0.004|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and day of surgery.||||0.004
71690034|NCT03299101|142896445|SUPERIORITY||Mean Difference (Net)|9.95|STANDARD_ERROR_OF_MEAN|4.9||0.042|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between baseline and 90 days postop.||||0.042
71930538|NCT02058368|143381779|SUPERIORITY|||||||0.42||||||P-value for IPSS improvement \>= 2 units has been presented for Month 21|Mantel Haenszel|||||||0.42
71930539|NCT02058368|143381779|SUPERIORITY|||||||0.084||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 21|Mantel Haenszel|||||||0.084
71930540|NCT02058368|143381779|SUPERIORITY|||||||0.016||||||P-value for IPSS improvement \>= 3 units has been presented for Month 24|Mantel Haenszel|||||||0.016
71930541|NCT02058368|143381779|SUPERIORITY|||||||0.047||||||P-value for IPSS improvement \>= 2 units has been presented for Month 24|Mantel Haenszel|||||||0.047
71930542|NCT02058368|143381779|SUPERIORITY|||||||0.007||||||P-value for IPSS improvement \>= 25 percent has been presented for Month 24|Mantel Haenszel|||||||0.007
71930543|NCT02058368|143381780|SUPERIORITY||Mean Difference (Final Values)|0.91|STANDARD_ERROR_OF_MEAN|0.33||0.006|TWO_SIDED|95.0|0.26|1.56||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.56|0.26|0.006
71930544|NCT02058368|143381780|SUPERIORITY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.35||0.005|TWO_SIDED|95.0|0.3|1.69||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||1.69|0.30|0.005
71930545|NCT02058368|143381780|SUPERIORITY||Mean Difference (Final Values)|1.46|STANDARD_ERROR_OF_MEAN|0.42|<|0.001|TWO_SIDED|95.0|0.63|2.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.29|0.63|<.001
71930546|NCT02058368|143381780|SUPERIORITY||Mean Difference (Final Values)|1.34|STANDARD_ERROR_OF_MEAN|0.41||0.001|TWO_SIDED|95.0|0.54|2.15||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||2.15|0.54|0.001
71930547|NCT02058368|143381781|SUPERIORITY|||||||0.13||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 6|Mantel Haenszel|||||||0.13
71930548|NCT02058368|143381781|SUPERIORITY|||||||0.15||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 6|Mantel Haenszel|||||||0.15
71930549|NCT02058368|143381781|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 12|Mantel Haenszel|||||||<.001
71930550|NCT02058368|143381781|SUPERIORITY|||||||0.003||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 12|Mantel Haenszel|||||||0.003
71930551|NCT02058368|143381781|SUPERIORITY|||||||0.002||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 18|Mantel Haenszel|||||||0.002
71930552|NCT02058368|143381781|SUPERIORITY|||||||0.009||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 18|Mantel Haenszel|||||||0.009
71930553|NCT02058368|143381781|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 3 mL/sec for Month 24|Mantel Haenszel|||||||<.001
71930554|NCT02058368|143381781|SUPERIORITY||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for \>= 30 % for Month 24|Mantel Haenszel|||||||<.001
71930555|NCT02058368|143381782|SUPERIORITY||Cox Proportional Hazard|0.27||||0.012|TWO_SIDED|95.0|0.09|0.81||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.81|0.09|0.012
71930556|NCT02058368|143381783|SUPERIORITY||Cox Proportional Hazard|0.15||||0.005|TWO_SIDED|95.0|0.03|0.68||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||0.68|0.03|0.005
71930557|NCT02058368|143381784|SUPERIORITY||Cox Proportional Hazard|0.69||||0.68|TWO_SIDED|95.0|0.11|4.11||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank|||||4.11|0.11|0.68
71930558|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.1||0.83|TWO_SIDED|95.0|-0.17|0.21||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.21|-0.17|0.83
71930559|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|-0.04|0.36||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.36|-0.04|0.11
71930560|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11||0.21|TWO_SIDED|95.0|-0.07|0.34||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.34|-0.07|0.21
71690035|NCT03299101|142896445|SUPERIORITY||Mean Difference (Net)|-3.77|STANDARD_ERROR_OF_MEAN|3.08||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.221
71690036|NCT03299101|142896446|SUPERIORITY|||||||0.814|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in max SMIP across all 4 time points.||||0.814
71690037|NCT03299101|142896446|SUPERIORITY||Mean Difference (Net)|10.5|STANDARD_ERROR_OF_MEAN|30.91||0.734|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and day of surgery.||||0.734
71930561|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.1||0.8|TWO_SIDED|95.0|-0.23|0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.18|-0.23|0.80
71690038|NCT03299101|142896446|SUPERIORITY||Mean Difference (Net)|21.07|STANDARD_ERROR_OF_MEAN|22.12||0.341|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between baseline and 90 days postop.||||0.341
71930562|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.37|TWO_SIDED|95.0|-0.3|0.11||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.11|-0.30|0.37
71930563|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11||0.44|TWO_SIDED|95.0|-0.3|0.13||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.13|-0.30|0.44
71930564|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.6|TWO_SIDED|95.0|-0.16|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.28|-0.16|0.60
71930565|NCT02058368|143381785|SUPERIORITY||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|0.11||0.16|TWO_SIDED|95.0|-0.37|0.06||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam|||0.06|-0.37|0.16
71930566|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.18||0.17|TWO_SIDED|95.0|-0.11|0.62||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 3|||0.62|-0.11|0.17
71930567|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.33|TWO_SIDED|95.0|-0.2|0.59||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 6|||0.59|-0.20|0.33
71930568|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.2||0.15|TWO_SIDED|95.0|-0.1|0.68||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 9|||0.68|-0.10|0.15
71930569|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.21||0.46|TWO_SIDED|95.0|-0.25|0.55||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 12|||0.55|-0.25|0.46
71930570|NCT02058368|143381786|SUPERIORITY||Median Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.21||0.59|TWO_SIDED|95.0|-0.51|0.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 15|||0.29|-0.51|0.59
71930571|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.2||0.56|TWO_SIDED|95.0|-0.52|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 18|||0.28|-0.52|0.56
71930572|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.21||0.51|TWO_SIDED|95.0|-0.56|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 21|||0.28|-0.56|0.51
71930573|NCT02058368|143381786|SUPERIORITY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.21||0.034|TWO_SIDED|95.0|-0.88|-0.03||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 24|||-0.03|-0.88|0.034
71690039|NCT03299101|142896446|SUPERIORITY||Mean Difference (Net)|28.55|STANDARD_ERROR_OF_MEAN|37.61||0.448|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in maximum SMIP between day of surgery and 90 days postop.||||0.448
71690040|NCT03299101|142896447|SUPERIORITY|||||||0.419|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in mean SMIP across all 4 time points.||||0.419
71690041|NCT03299101|142896447|SUPERIORITY||Mean Difference (Net)|20.91|STANDARD_ERROR_OF_MEAN|27.03||0.439|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and day of surgery.||||0.439
71930574|NCT02058368|143381787|SUPERIORITY||Mean Difference (Final Values)|-1.02|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.54|-0.5||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.50|-1.54|<.001
71930575|NCT02058368|143381787|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.27||0.009|TWO_SIDED|95.0|-1.23|-0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-0.18|-1.23|0.009
71930576|NCT02058368|143381792|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-2.1|-1.6||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.6|-2.1|<.001
71930577|NCT02058368|143381792|SUPERIORITY||Mean Difference (Final Values)|-2.1|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|95.0|-2.3|-1.9||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-1.9|-2.3|<.001
71930578|NCT02058368|143381792|SUPERIORITY||Mean Difference (Final Values)|-2.7|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-3.1|-2.2||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.|||-2.2|-3.1|<.001
71930579|NCT02058368|143381794|SUPERIORITY|||||||0.77||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6|Van Elteren test|||||||0.77
71930580|NCT02058368|143381794|SUPERIORITY|||||||0.84||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12|Van Elteren test|||||||0.84
71930581|NCT02058368|143381794|SUPERIORITY|||||||0.98||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18|Van Elteren test|||||||0.98
71930582|NCT02058368|143381794|SUPERIORITY|||||||0.28||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24|Van Elteren test|||||||0.28
71930583|NCT02392559|143381817|SUPERIORITY||treatment difference|-38.3|STANDARD_ERROR_OF_MEAN|3.66|<|0.0001|TWO_SIDED|95.0|-45.54|-31.06|||repeated measures model||Treatment difference uses placebo as the reference.|||-31.06|-45.54|< 0.0001
71930584|NCT02392559|143381817|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930585|NCT02392559|143381818|SUPERIORITY||treatment difference|-42.09|STANDARD_ERROR_OF_MEAN|3.17|<|0.0001|TWO_SIDED|95.0|-48.34|-35.83|||repeated measures model||Treatment difference uses placebo as the reference.|||-35.83|-48.34|< 0.0001
71930586|NCT02392559|143381818|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930587|NCT02392559|143381819|SUPERIORITY||treatment difference|-68.6|STANDARD_ERROR_OF_MEAN|7.3|<|0.0001|TWO_SIDED|95.0|-83.1|-54.0||Treatment difference uses placebo as the reference.|repeated measures model|||||-54.0|-83.1|< 0.0001
71930588|NCT02392559|143381819|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930589|NCT02392559|143381820|SUPERIORITY||treatment difference|-35.04|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-41.79|-28.3|||repeated measures model||Treatment difference uses placebo as the reference.|||-28.30|-41.79|< 0.0001
71930590|NCT02392559|143381820|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930591|NCT02392559|143381821|SUPERIORITY||treatment difference|-32.47|STANDARD_ERROR_OF_MEAN|3.21|<|0.0001|TWO_SIDED|95.0|-38.82|-26.13|||repeated measures model||Treatment difference uses placebo as the reference.|||-26.13|-38.82|< 0.0001
71930592|NCT02392559|143381821|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930593|NCT02392559|143381822|SUPERIORITY||treatment difference|-30.3|STANDARD_ERROR_OF_MEAN|3.09|<|0.0001|TWO_SIDED|95.0|-36.4|-24.21|||repeated measures model||Treatment difference uses placebo as the reference.|||-24.21|-36.40|< 0.0001
71930594|NCT02392559|143381822|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930595|NCT02392559|143381823|SUPERIORITY||treatment difference|-36.38|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|95.0|-42.97|-29.8|||repeated measures model||Treatment difference uses placebo as the reference.|||-29.80|-42.97|< 0.0001
71690042|NCT03299101|142896447|SUPERIORITY||Mean Difference (Net)|47.67|STANDARD_ERROR_OF_MEAN|26.19||0.069|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between baseline and 90 days postop.||||0.069
71690043|NCT03299101|142896447|SUPERIORITY||Mean Difference (Net)|37.11|STANDARD_ERROR_OF_MEAN|37.96||0.328|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean SMIP between day of surgery and 90 days postop.||||0.328
71690044|NCT03299101|142896448|SUPERIORITY|||||||0.196|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in serum prealbumin across all 4 time points.||||0.196
71930596|NCT02392559|143381823|SUPERIORITY||||||<|0.0001||||||Adjusted p-value based on a combination of sequential testing and the Hochberg procedure to control the overall significance level for all primary and secondary endpoints.|sequential testing/Hochberg procedure|Adjusted p-value is compared to 0.05 to determine statistical significance.||||||< 0.0001
71930597|NCT02149199|143381836|SUPERIORITY||Odds Ratio (OR)|1.14||||0.046|TWO_SIDED|95.0|1.0|1.3|||Regression, Logistic|Repeated measures logistic regression, with treatment, pre-study treatment, region and study week as fixed effects.|An odds ratio greater than 1 favours Symbicort 'as needed'|||1.30|1.00|0.046
71930598|NCT02149199|143381836|NON_INFERIORITY|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI \>=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid.|Odds Ratio (OR)|0.64|||||TWO_SIDED|95.0|0.57|0.73|||Regression, Logistic|Repeated measures logistic regression with treatment, pre-study treatment, region and study week as fixed effects.||||0.73|0.57|
71930599|NCT02149199|143381837|SUPERIORITY||Hazard Ratio (HR)|0.435|||<|0.001|TWO_SIDED|95.0|0.328|0.577|||Regression, Cox|Cox-regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0, \>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||0.577|0.328|<0.001
71930600|NCT02149199|143381837|SUPERIORITY||Hazard Ratio (HR)|0.901||||0.524|TWO_SIDED|95.0|0.653|1.242|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.|||1.242|0.653|0.524
71930601|NCT02149199|143381838|SUPERIORITY||Hazard Ratio (HR)|0.429|||<|0.001|TWO_SIDED|95.0|0.348|0.528|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||0.528|0.348|<0.001
71930602|NCT02149199|143381838|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.436|TWO_SIDED|95.0|0.718|1.153|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.|||1.153|0.718|0.436
71690045|NCT03299101|142896448|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.19||0.562|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and day of surgery.||||0.562
71930603|NCT02149199|143381839|SUPERIORITY||Mean Difference (Net)|53.8|||<|0.001|TWO_SIDED|95.0|29.1|78.5|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||78.5|29.1|<0.001
71930604|NCT02149199|143381839|SUPERIORITY||Mean Difference (Net)|-54.3|||<|0.001|TWO_SIDED|95.0|-78.8|-29.8|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.|||-29.8|-78.8|<0.001
71690046|NCT03299101|142896448|SUPERIORITY||Mean Difference (Net)|-0.42|STANDARD_ERROR_OF_MEAN|0.25||0.087|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between baseline and 90 days postop.||||0.087
71930605|NCT02149199|143381840|SUPERIORITY||Mean Difference (Net)|11.95|||<|0.001|TWO_SIDED|95.0|7.89|16.0|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||16.00|7.89|<0.001
71930606|NCT02149199|143381840|SUPERIORITY||Mean Difference (Net)|-9.98|||<|0.001|TWO_SIDED|95.0|-14.03|-5.93|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-5.93|-14.03|<0.001
71930607|NCT02149199|143381841|SUPERIORITY||Mean Difference (Net)|10.94|||<|0.001|TWO_SIDED|95.0|6.99|14.9|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||14.90|6.99|<0.001
71930608|NCT02149199|143381841|SUPERIORITY||Mean Difference (Net)|-6.23||||0.002|TWO_SIDED|95.0|-10.18|-2.29|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.|||-2.29|-10.18|0.002
71690047|NCT03299101|142896448|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.226|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in serum prealbumin between day of surgery and 90 days postop.||||0.226
71690048|NCT03299101|142896449|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in gait speed across all 4 time points.||||0.001
71930609|NCT02149199|143381843|SUPERIORITY||Mean Difference (Net)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.18|-0.06|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.06|-0.18|<0.001
71930610|NCT02149199|143381843|SUPERIORITY||Mean Difference (Net)|0.09||||0.004|TWO_SIDED|95.0|0.03|0.15|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.|||0.15|0.03|0.004
71930611|NCT02149199|143381850|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|0.001|TWO_SIDED|95.0|0.343|0.497|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||0.497|0.343|<0.001
71930612|NCT02149199|143381850|SUPERIORITY||Hazard Ratio (HR)|0.865||||0.175|TWO_SIDED|95.0|0.701|1.067|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.|||1.067|0.701|0.175
71930613|NCT02149199|143381851|SUPERIORITY||Mean Difference (Net)|-0.154|||<|0.001|TWO_SIDED|95.0|-0.203|-0.105|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||-0.105|-0.203|<0.001
71930614|NCT02149199|143381851|SUPERIORITY||Mean Difference (Net)|0.149|||<|0.001|TWO_SIDED|95.0|0.101|0.198|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.|||0.198|0.101|<0.001
71930615|NCT02149199|143381852|SUPERIORITY||Mean Difference (Net)|0.127|||<|0.001|TWO_SIDED|95.0|0.074|0.181|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||0.181|0.074|<0.001
71930616|NCT02149199|143381852|SUPERIORITY||Mean Difference (Net)|-0.102|||<|0.001|TWO_SIDED|95.0|-0.155|-0.049|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.|||-0.049|-0.155|<0.001
71930617|NCT02149199|143381854|SUPERIORITY||Rate ratio|0.36|||<|0.001|TWO_SIDED|95.0|0.27|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.27|<0.001
71930618|NCT02149199|143381854|SUPERIORITY||Rate ratio|0.83||||0.279|TWO_SIDED|95.0|0.59|1.16|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.|||1.16|0.59|0.279
71930619|NCT02149199|143381855|SUPERIORITY||Rate ratio|0.4|||<|0.001|TWO_SIDED|95.0|0.32|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||0.49|0.32|<0.001
71930620|NCT02149199|143381855|SUPERIORITY||Rate ratio|0.95||||0.663|TWO_SIDED|95.0|0.74|1.21|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,\>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.|||1.21|0.74|0.663
71930621|NCT02395536|143381899|NON_INFERIORITY|A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting.|Risk Difference (RD)|-0.001|||<|0.001|TWO_SIDED|95.0|-0.03|0.029||P-value for non-inferiority versus a 5% non-inferiority margin.|Farrington-Manning test||The estimated value and its associated confidence interval are for the in-office minus traditional hospital setting difference in the untoward event rates. The point estimate is negative since the in-office rate was lower than the hospital rate.|The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.||0.029|-0.030|<0.001
71930622|NCT02038959|143381917|SUPERIORITY_OR_OTHER||||||>|0.05|||||||ANCOVA|||||||>0.05
71930623|NCT02038959|143381922|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71930624|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|81.1237||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for entry criteria||||||0.0001
71930625|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.973||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for model entry||||||0.0001
71930626|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|7.1526||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% significance level for entry criteria||||||0.0075
71930627|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.409||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% Significance Level for model entry||||||0.0075
71930628|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|51.8456||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% significance level for entry criteria||||||0.0001
71930629|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.515||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71930630|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|98.1065||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71930631|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.929||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71930632|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|2.8589||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for entry criteria||||||0.0909
71930633|NCT01788163|143381984|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.086||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for model entry||||||0.0909
71930634|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|11.106||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for entry criteria||||||0.0009
71930635|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.561||||0.0009||||||Age: \<=65 vs. \>65|Regression Stepwise|10% Significance Level for model entry||||||0.0009
71930636|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|34.1075||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71930637|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.386||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% significance level for model entry||||||0.0001
71930638|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|14.0806||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for entry criteria||||||0.0002
71930639|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.955||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for model entry||||||0.0002
71930640|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|33.8574||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71930641|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.077||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71930642|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Wald Chi Square Statistic|21.2537||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria||||||0.0001
71930643|NCT01788163|143381987|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.084||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry||||||0.0001
71930644|NCT00545441|143381992|NON_INFERIORITY_OR_EQUIVALENCE|Alpha = 0.05 and power = 0.8, a non-inferiority margin of 10%.||||||0.59|TWO_SIDED||||||Fisher Exact|||||||0.59
71930645|NCT03610646|143381997|EQUIVALENCE|An equivalence margin of \[-3, 3\] letters was used to demonstrate equivalence for the difference of mean change in BCVA, from baseline to Week 8.|Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.73|||TWO_SIDED|90.0|-1.16|1.24||||||||1.24|-1.16|
71930646|NCT00467038|143382005|SUPERIORITY_OR_OTHER||||||<|0.004|TWO_SIDED||||||t-test, 1 sided|\<0.004 p value was common for all time points.||||||<0.004
71930647|NCT00467038|143382006|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Fisher's LSD post-hoc, trend level|||||||0.08
71930648|NCT04071366|143382028|SUPERIORITY||Difference in CRS rate|-0.39||||0.003|TWO_SIDED|95.0|-0.6463|-0.1363|||One-sided Z-test|||||-0.1363|-0.6463|0.0030
71930649|NCT04071366|143382028|OTHER||Difference in CRS rate|-0.37|||||TWO_SIDED|95.0|-0.6073|-0.1231||||||||-0.1231|-0.6073|
71930650|NCT04071366|143382028|OTHER||Difference in CRS rate|0.03|||||TWO_SIDED|95.0|-0.1778|0.2299||||||||0.2299|-0.1778|
71930651|NCT02115373|143382128|OTHER||Median|2.07|||||TWO_SIDED|90.0|1.446|7.195|||||TTP in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||7.195|1.446|
71930652|NCT02115373|143382128|OTHER||Median|3.98|||||TWO_SIDED|90.0|2.858|4.238|||||TTP in months was calculated for Phase 2: Tepotinib 500 mg.|||4.238|2.858|
71930653|NCT02115373|143382129|OTHER||Median|1.51|||||TWO_SIDED|90.0|1.413|3.68|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.680|1.413|
71930654|NCT02115373|143382129|OTHER||Median|3.22|||||TWO_SIDED|90.0|0.03|16.53|||||PFS time in months was calculated for Phase 2: Tepotinib 500 mg.|||16.53|0.03|
71930655|NCT02115373|143382130|OTHER||Median|1.48|||||TWO_SIDED|90.0|1.413|3.844|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||3.844|1.413|
71930656|NCT02115373|143382130|OTHER||Median|3.35|||||TWO_SIDED|90.0|2.76|4.172|||||PFS time in months was was calculated for Phase 2: Tepotinib 500 mg.|||4.172|2.760|
71930657|NCT02115373|143382132|OTHER||Median|7.2|||||TWO_SIDED|90.0|3.68|10.119|||||Overall Survival time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.|||10.119|3.680|
71930658|NCT02115373|143382132|OTHER||Median|5.55|||||TWO_SIDED|90.0|5.092|8.181|||||Overall Survival time in months was calculated for Phase 2: Tepotinib 500 mg.|||8.181|5.092|
71930659|NCT03747939|143382153|SUPERIORITY||Adjusted difference in proportions|18.5||||0.0008|TWO_SIDED|95.0|8.9|28.1|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per Interactive Web Response System (IWRS) data, using Cochran-Mantel-Haenszel (CMH) weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||28.1|8.9|0.0008
71930660|NCT03747939|143382154|SUPERIORITY||Adjusted difference in proportions|18.6||||0.0017|TWO_SIDED|95.0|7.0|30.2|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||30.2|7.0|0.0017
71930661|NCT03747939|143382155|SUPERIORITY||Adjusted difference in proportions|5.1||||0.3539|TWO_SIDED|95.0|-5.8|16.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||16.0|-5.8|0.3539
71930662|NCT03747939|143382156|SUPERIORITY||Adjusted difference in proportions|22.1||||0.0003|TWO_SIDED|95.0|10.4|33.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||33.7|10.4|0.0003
71930663|NCT03747939|143382157|SUPERIORITY||Adjusted difference in proportions|11.8||||0.0286|TWO_SIDED|95.0|1.7|22.0|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||22.0|1.7|0.0286
71930664|NCT03747939|143382158|SUPERIORITY||Adjusted difference in proportions|16.3||||0.0022|TWO_SIDED|95.0|6.9|25.8|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||25.8|6.9|0.0022
71930665|NCT03747939|143382159|SUPERIORITY||Difference in LS means|-1.03|||<|0.0001|TWO_SIDED|95.0|-1.48|-0.59|||MMRM||Apremilast - Placebo|Difference in LS means is based MMRM of the change from baseline.||-0.59|-1.48|<0.0001
71930666|NCT03747939|143382160|SUPERIORITY||Adjusted difference in proportions|17.7||||0.0043|TWO_SIDED|95.0|5.7|29.7|||Cochran-Mantel-Haenszel|Two-sided p-value adjusted for prior/concomitant use of csDMARD and baseline glucocorticosteroid use, normalized via Wilson-Hilferty transformation.|Apremilast - Placebo|Adjusted difference in proportions is the weighted average of the treatment differences across strata formed by two stratification factors, prior/concomitant use of csDMARD and baseline glucocorticosteroid use per IWRS data, using CMH weights. Two-sided 95% CI is based on a normal approximation to the weighted average.||29.7|5.7|0.0043
71930667|NCT01523301|143382161|SUPERIORITY_OR_OTHER||Difference in LS Mean|-1.12|||=|0.1286|TWO_SIDED|95.0|-2.56|0.33||The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.|ANCOVA|||The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.||0.33|-2.56|=0.1286
71930668|NCT01447628|143382170|SUPERIORITY|||||||0.6039|||||||Mixed Models Analysis|||||||0.6039
71930669|NCT01447628|143382171|SUPERIORITY|||||||0.0747|||||||Mixed Models Analysis|||||||0.0747
71930670|NCT01447628|143382171|SUPERIORITY|||||||0.799|||||||Mixed Models Analysis|||||||0.7990
71930671|NCT01447628|143382171|SUPERIORITY|||||||0.2111|||||||Mixed Models Analysis|||This is a combination of the p-values from the separate analyses of each data set.||||0.2111
71930672|NCT01447628|143382172|SUPERIORITY|||||||0.6583|||||||Mixed Models Analysis|||||||0.6583
71930673|NCT01447628|143382172|SUPERIORITY|||||||0.9166|||||||Mixed Models Analysis|||||||0.9166
71930674|NCT01447628|143382172|SUPERIORITY|||||||0.6631|||||||Mixed Models Analysis|||||||0.6631
71930675|NCT01447628|143382173|SUPERIORITY|||||||0.4039|||||||Mixed Models Analysis|||||||0.4039
71930676|NCT01447628|143382173|SUPERIORITY|||||||0.9144|||||||Mixed Models Analysis|||||||0.9144
71930677|NCT01447628|143382173|SUPERIORITY|||||||0.9959|||||||Mixed Models Analysis|||||||0.9959
71930678|NCT01447628|143382174|SUPERIORITY|||||||0.1788|||||||Mixed Models Analysis|||||||0.1788
71930679|NCT01447628|143382174|SUPERIORITY|||||||0.7795|||||||Mixed Models Analysis|||||||0.7795
71930680|NCT01447628|143382174|SUPERIORITY|||||||0.414|||||||Mixed Models Analysis|||||||0.414
71930681|NCT01447628|143382175|SUPERIORITY|||||||0.8688|||||||Mixed Models Analysis|||||||0.8688
71930682|NCT01447628|143382175|SUPERIORITY|||||||0.9999|||||||Mixed Models Analysis|||||||0.9999
71930683|NCT01447628|143382175|SUPERIORITY|||||||0.991|||||||Mixed Models Analysis|||||||0.991
71930684|NCT01447628|143382176|SUPERIORITY|||||||0.5465|||||||Mixed Models Analysis|||||||0.5465
71930685|NCT01447628|143382176|SUPERIORITY|||||||0.4298|||||||Mixed Models Analysis|||||||0.4298
71930686|NCT01447628|143382176|SUPERIORITY|||||||0.5451|||||||Mixed Models Analysis|||||||0.5451
71930687|NCT01447628|143382177|SUPERIORITY|||||||0.6241|||||||Mixed Models Analysis|||Note that Endurance CPET was not done in China, hence only European data provided.||||0.6241
71930688|NCT01447628|143382178|SUPERIORITY|||||||0.4758|||||||Mixed Models Analysis|||||||0.4758
71930689|NCT01447628|143382179|SUPERIORITY|||||||0.205|||||||Mixed Models Analysis|||||||0.2050
71930690|NCT01447628|143382179|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
71930691|NCT01447628|143382179|SUPERIORITY|||||||0.1993|||||||Mixed Models Analysis|||||||0.1993
71930692|NCT01447628|143382180|SUPERIORITY|||||||0.061|||||||Mixed Models Analysis|||||||0.0610
71930693|NCT01447628|143382180|SUPERIORITY|||||||0.0641|||||||Mixed Models Analysis|||||||0.0641
71930694|NCT01447628|143382181|SUPERIORITY|||||||0.0003|||||||Mixed Models Analysis|||||||0.0003
71930695|NCT01447628|143382181|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71930696|NCT01447628|143382181|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71930697|NCT01447628|143382182|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71930698|NCT01447628|143382183|SUPERIORITY|||||||0.8093|||||||Mixed Models Analysis|||||||0.8093
71930699|NCT01447628|143382183|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|||||||0.6300
71930700|NCT01447628|143382183|SUPERIORITY|||||||0.8533|||||||Mixed Models Analysis|||||||0.8533
71930701|NCT01447628|143382184|SUPERIORITY|||||||0.0725|||||||Mixed Models Analysis|||||||0.0725
71930702|NCT01447628|143382184|SUPERIORITY|||||||0.8572|||||||Mixed Models Analysis|||||||0.8572
71930703|NCT01447628|143382184|SUPERIORITY|||||||0.2348|||||||Mixed Models Analysis|||||||0.2348
71930704|NCT01447628|143382185|SUPERIORITY|||||||0.1115|||||||Mixed Models Analysis|||||||0.1115
71930705|NCT01447628|143382186|SUPERIORITY|||||||0.979|||||||Mixed Models Analysis|||||||0.9790
71930706|NCT01447628|143382187|SUPERIORITY|||||||0.7702|||||||Mixed Models Analysis|||||||0.7702
71930707|NCT01447628|143382188|SUPERIORITY|||||||0.2219|||||||Mixed Models Analysis|||||||0.2219
71930708|NCT01447628|143382189|SUPERIORITY|||||||0.1777|||||||Mixed Models Analysis|||||||0.1777
71930709|NCT01447628|143382189|SUPERIORITY|||||||0.7889|||||||Mixed Models Analysis|||||||0.7889
71930710|NCT01447628|143382189|SUPERIORITY|||||||0.4156|||||||Mixed Models Analysis|||||||0.4156
71930711|NCT01447628|143382190|SUPERIORITY|||||||0.7625|||||||Mixed Models Analysis|||||||0.7625
71930712|NCT01447628|143382190|SUPERIORITY|||||||0.2262|||||||Mixed Models Analysis|||||||0.2262
71930713|NCT01447628|143382190|SUPERIORITY|||||||0.4756|||||||Mixed Models Analysis|||||||0.4756
71930714|NCT01447628|143382191|SUPERIORITY|||||||0.7711|||||||Mixed Models Analysis|||||||0.7711
71930715|NCT01447628|143382191|SUPERIORITY|||||||0.7806|||||||Mixed Models Analysis|||||||0.7806
71930716|NCT01447628|143382191|SUPERIORITY|||||||0.9074|||||||Mixed Models Analysis|||||||0.9074
71930717|NCT01447628|143382192|SUPERIORITY|||||||0.9504|||||||Mixed Models Analysis|||||||0.9504
71930718|NCT01447628|143382192|SUPERIORITY|||||||0.8666|||||||Mixed Models Analysis|||||||0.8666
71930719|NCT01447628|143382192|SUPERIORITY|||||||0.8104|||||||Mixed Models Analysis|||||||0.8104
71930720|NCT01447628|143382193|SUPERIORITY|||||||0.4478|||||||Mixed Models Analysis|||||||0.4478
71930721|NCT01447628|143382194|SUPERIORITY|||||||0.459|||||||Mixed Models Analysis|||||||0.4590
71930722|NCT01447628|143382195|SUPERIORITY|||||||0.8086|||||||Mixed Models Analysis|||||||0.8086
71930723|NCT01447628|143382196|SUPERIORITY|||||||0.6944|||||||Mixed Models Analysis|||||||0.6944
71930724|NCT01447628|143382197|SUPERIORITY|||||||0.585|||||||Mixed Models Analysis|||||||0.585
71930725|NCT01447628|143382198|SUPERIORITY|||||||0.4619|||||||Mixed Models Analysis|||||||0.4619
71930726|NCT01447628|143382199|SUPERIORITY|||||||0.7721|||||||Mixed Models Analysis|||||||0.7721
71930727|NCT01447628|143382200|SUPERIORITY|||||||0.8332|||||||Mixed Models Analysis|||||||0.8332
71930728|NCT01447628|143382201|SUPERIORITY|||||||0.2651|||||||Mixed Models Analysis|||||||0.2651
71930729|NCT00639158|143382211|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
71930730|NCT00639158|143382212|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||0.004
71930731|NCT00639158|143382213|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||A sample size of 212 per arm provided 90% power and \> 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.||||< 0.001
71930732|NCT00639158|143382214|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71930733|NCT00639158|143382215|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71930734|NCT00639158|143382216|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71930735|NCT00639158|143382217|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71690049|NCT03299101|142896449|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.04||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between baseline and day of surgery.||||0.001
71690050|NCT03299101|142896449|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.05||0.001|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests|Linear mixed models estimated within-person change in gait speed between baseline and 90 days postop.||||0.001
71690051|NCT03299101|142896449|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.05||0.874|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in gait speed between day of surgery and 90 days postop.||||0.874
71690052|NCT03299101|142896450|SUPERIORITY|||||||0.854|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SPPB across all 4 time points.||||0.854
71690053|NCT03299101|142896450|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.32||0.298|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and day of surgery.||||0.298
71690054|NCT03299101|142896450|SUPERIORITY||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|0.31||0.684|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between baseline and 90 days postop.||||0.684
71930736|NCT00639158|143382218|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|Rank-sum test||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.||||< 0.001
71690055|NCT03299101|142896450|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.33||0.485|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SPPB between day of surgery and 90 days postop.||||0.485
71930737|NCT02180659|143382238|NON_INFERIORITY|"For the primary efficacy variable, a test of non-inferiority of Probuphine (active) versus SL BPN (control) responders was conducted. A non-inferiority margin of 20% was employed to define noninferiority.~A Confidence Interval (CI) for the difference in proportions was calculated, and non-inferiority was established if the lower bound of the 95% CI for the difference of proportions (Probuphine - SL BPN) was greater than -0.20."|Difference in Response Rate|0.088|||<|0.001|TWO_SIDED|95.0|0.009|0.167|||Chi-squared|||||0.167|0.009|<.001
71930738|NCT02180659|143382239|SUPERIORITY|At month 6 comparing those subject with no illicit drug use.||||||0.306|||||||Chi-squared|||||||0.306
71930739|NCT02180659|143382240|SUPERIORITY|||||||0.037|||||||Log Rank|||||||.037
71690056|NCT03299101|142896451|SUPERIORITY|||||||0.067|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in RAI across all 4 time points.||||0.067
71690057|NCT03299101|142896451|SUPERIORITY||Mean Difference (Net)|2.07|STANDARD_ERROR_OF_MEAN|1.22||0.089|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and day of surgery.||||0.089
71690058|NCT03299101|142896451|SUPERIORITY||Mean Difference (Net)|4.37|STANDARD_ERROR_OF_MEAN|1.6||0.006|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between baseline and 90 days postop.||||0.006
71690059|NCT03299101|142896451|SUPERIORITY||Mean Difference (Net)|1.98|STANDARD_ERROR_OF_MEAN|1.62||0.221|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in RAI between day of surgery and 90 days postop.||||0.221
71690060|NCT03299101|142896452|SUPERIORITY|||||||0.86|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in SGA across all 4 time points.||||0.860
71690061|NCT03299101|142896452|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.41|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and day of surgery.||||0.410
71690062|NCT03299101|142896452|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.17||0.622|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between baseline and 90 days postop.||||0.622
71930740|NCT02180659|143382242|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.832|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.832
71930741|NCT02180659|143382243|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.922|TWO_SIDED||||||ANOVA|||||||0.922
71930742|NCT02180659|143382244|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.425|TWO_SIDED||||||ANOVA|||||||0.425
71930743|NCT02180659|143382245|SUPERIORITY||Median Difference (Final Values)|-1.3||||0.505|TWO_SIDED||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.||||0.505
71930744|NCT00929864|143382282|NON_INFERIORITY_OR_EQUIVALENCE|Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).|Difference from adalimumab at Day 365|1.8|||||TWO_SIDED|95.0|-5.6|9.2|||minimum risk weights method|adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||The null and alternative hypotheses are H0: T - C\<= δ vs. Ha:T - C \> δ, where T is the treatment effect of abatacept, C is the effect of active control (adalimumab),and δ is non-inferiority margin. Abatacept is defined as δ non-inferior to adalimumab when H0 is rejected. More specifically, if the lower bound of the 95% two-sided confidence interval for C-T is greater than δ,, then that Abatacept is δ non-inferior to adalimumab can be claimed.||9.2|-5.6|
71930745|NCT00929864|143382283|SUPERIORITY_OR_OTHER||Difference in proportions|-5.37||||0.006|TWO_SIDED|95.0|-9.13|-1.62|||Chi-squared|||Analysis is p-value of difference in proportions. n=number of participants with event, N=number of participants at risk. Proportion = n/N. In order to maintain the overall type I error rate of 0.05 for testing both the primary non-inferiority hypothesis and the key secondary local injection site reaction (LISR) hypothesis, the LISR hypothesis was tested at the 5% significance level only after the primary non-inferiority hypothesis is established at the 5% level.||-1.62|-9.13|0.006
71930746|NCT00929864|143382284|SUPERIORITY_OR_OTHER||Difference from adalimumab|-4.13|||||TWO_SIDED|95.0|-6.55|-1.72||||||Analysis of incidence rate at 24 months. Point estimate and 95% CI. Poisson distribution was used to construct the 95% CIs.||-1.72|-6.55|
71930747|NCT00929864|143382285|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 365|-1.3|||||TWO_SIDED|95.0|-6.5|3.9|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 365.||3.9|-6.5|
71930748|NCT00929864|143382285|SUPERIORITY_OR_OTHER||Difference from adalimumab at Day 729|0.9|||||TWO_SIDED|95.0|-5.5|7.3|||minimum risk weights method|Adjusted for randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).||This analysis is for Day 729.||7.3|-5.5|
71930749|NCT00929864|143382286|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.8|||||TWO_SIDED|95.0|-4.51|6.11||||||Analysis for incidence rate of SAE at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||6.11|-4.51|
71930750|NCT00929864|143382286|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.67|||||TWO_SIDED|95.0|-3.27|1.94||||||Analysis for incidence rate of Serious Infections and Infestations at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.94|-3.27|
71930751|NCT00929864|143382286|SUPERIORITY_OR_OTHER||Difference from adalimumab|0.0|||||TWO_SIDED|95.0|-0.92|0.91||||||Analysis for incidence rate of Opportunistic Infections at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.91|-0.92|
71930752|NCT00929864|143382286|SUPERIORITY_OR_OTHER||Difference from adalimumab|-5.32|||||TWO_SIDED|95.0|-12.06|1.41||||||Analysis for incidence rate of discontinuation for any cause at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.41|-12.06|
71930753|NCT00929864|143382287|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.91|||||TWO_SIDED|95.0|-5.43|1.61||||||Analysis for incidence rate of SAE at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||1.61|-5.43|
71930754|NCT00929864|143382287|SUPERIORITY_OR_OTHER||Difference from adalimumab|-1.24|||||TWO_SIDED|95.0|-3.12|0.63||||||Analysis for incidence rate of Serious infections and infestations Adverse Events at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.63|-3.12|
71930755|NCT00929864|143382287|SUPERIORITY_OR_OTHER||Difference from adalimumab|-0.52|||||TWO_SIDED|95.0|-1.39|0.36|||minimum risk weights method|||Analysis for incidence rate of opportunistic infections at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.36|-1.39|
71930756|NCT00929864|143382287|SUPERIORITY_OR_OTHER||Difference from adalimumab|-3.1|||||TWO_SIDED|95.0|-7.13|0.92||||||Analysis for incidence rate of discontinuations (all cause) at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.||0.92|-7.13|
71930757|NCT00929864|143382288|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.1|||||TWO_SIDED|95.0|-13.9|-2.2||||||Analysis for ANA at Day 365. Point estimate and 95% CI for treatment difference.||-2.2|-13.9|
71930758|NCT00929864|143382288|SUPERIORITY_OR_OTHER||Difference from adalimumab|-8.4|||||TWO_SIDED|95.0|-15.3|-1.5||||||Analysis for ANA at Day 729. Point estimate and 95% CI for treatment difference||-1.5|-15.3|
71930759|NCT00929864|143382288|SUPERIORITY_OR_OTHER||Difference from adalimumab|-9.6|||||TWO_SIDED|95.0|-13.4|-5.7||||||Analysis for dsDNA at Day 365. Point estimate and 95% CI for treatment difference.||-5.7|-13.4|
71930760|NCT00929864|143382288|SUPERIORITY_OR_OTHER||Difference from adalimumab|-12.2|||||TWO_SIDED|95.0|-16.9|-7.6||||||Analysis for dsDNA at Day 729. Point estimate and 95% CI for treatment difference.||-7.6|-16.9|
71930761|NCT01345058|143382298|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.49|TWO_SIDED|95.0|0.35|1.65|||Chi-squared||Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.|||1.65|0.35|0.49
71930762|NCT01892020|143382314|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.12|STANDARD_ERROR_OF_MEAN|0.27|<|0.001||95.0|-1.66|-0.58||The 2-h PPG increment was analyzed using a normal linear mixed model with period and treatment as fixed effects and subject as a random effect.|Mixed Models Analysis|||Let D be the treatment difference (BIAsp 50 BID + metformin minus BHI 50 BID + metformin) of 2-h PPG increment after a 4-week treatment. The null hypothesis was D = 0 mmol/L. The alternative hypothesis was D ≠ 0 mmol/L. Sample size was determined using a two-sided one sample t-test at a = 0.05 under the assumption of 0.8 mmol/L mean treatment different and 80% power.||-0.58|-1.66|< 0.001
71930763|NCT01500434|143382487|NON_INFERIORITY_OR_EQUIVALENCE|Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.|Target Lesion Failure Rate|3.2|||<|0.0001|ONE_SIDED|95.0||7.96|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.||7.96||<0.0001
71930764|NCT01966107|143382516|SUPERIORITY||Rate ratio|0.65||||0.006|TWO_SIDED|95.0|0.48|0.89|||Negative Binomial Regression model||||A rate ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|0.89|0.48|0.006
71930765|NCT01966107|143382518|NON_INFERIORITY|Estimate of the hazard ratio and its 95% CI for comparing aclidinium bromide 400 μg versus placebo were derived using the Cox proportional hazard model. A hazard ratio \<1 represents a favorable outcome for aclidinium bromide 400 μg.|Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.64|1.23||||||Composite MACE||1.23|0.64|
71930766|NCT00532779|143382519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.67|||<|0.001||95.0|-4.5|-2.85|||ANCOVA|||||-2.85|-4.50|<0.001
71930767|NCT00532779|143382519|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.81|||<|0.001|TWO_SIDED|95.0|-5.63|-3.99|||ANCOVA|||||-3.99|-5.63|<0.001
71930768|NCT00532779|143382520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.42|||<|0.001||95.0|2.52|4.63|||Regression, Logistic|||||4.63|2.52|<0.001
71930769|NCT00532779|143382520|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.86|||<|0.001||95.0|3.6|6.57|||Regression, Logistic|||||6.57|3.60|<0.001
71930770|NCT00532779|143382521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.21|||<|0.001|TWO_SIDED|95.0|2.14|4.81|||Regression, Logistic|||||4.81|2.14|<0.001
71930771|NCT00532779|143382521|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.19|||<|0.001|TWO_SIDED|95.0|2.82|6.23|||Regression, Logistic|||||6.23|2.82|<0.001
71930772|NCT00532779|143382522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.58|||<|0.001|TWO_SIDED|95.0|-3.74|-1.43|||ANCOVA|||||-1.43|-3.74|<0.001
71930773|NCT00532779|143382522|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.78|||<|0.001|TWO_SIDED|95.0|-4.93|-2.64|||ANCOVA|||||-2.64|-4.93|<0.001
71930774|NCT00532779|143382523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.42|||<|0.001|TWO_SIDED|95.0|2.17|4.66|||ANCOVA|||||4.66|2.17|<0.001
71930775|NCT00532779|143382523|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.48|||<|0.001|TWO_SIDED|95.0|2.26|4.7|||ANCOVA|||||4.70|2.26|<0.001
71930776|NCT00532779|143382524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.88|||=|0.046|TWO_SIDED||||||ANCOVA|||||||=0.046
71930777|NCT00532779|143382524|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-9.61|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71930778|NCT00532779|143382525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.13|||<|0.001|TWO_SIDED|95.0|1.72|4.54|||ANCOVA|||||4.54|1.72|<0.001
71930779|NCT00532779|143382525|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.14|||<|0.001|TWO_SIDED|95.0|2.73|5.56|||ANCOVA|||||5.56|2.73|<0.001
71930780|NCT00532779|143382526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.36|||=|0.016|TWO_SIDED||||||ANCOVA|||||||=0.016
71930781|NCT00532779|143382526|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.32|||=|0.008|TWO_SIDED||||||ANCOVA|||||||=0.008
71930782|NCT00532779|143382527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-7.27|||=|0.063|TWO_SIDED||||||ANCOVA|||||||=0.063
71930783|NCT00532779|143382527|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.57|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71930784|NCT00532779|143382528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.09|||||TWO_SIDED|95.0|-2.6|0.42||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.42|-2.60|
71930785|NCT00532779|143382528|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.94|||=|0.01|TWO_SIDED|95.0|-3.42|-0.46|||ANCOVA|||||-0.46|-3.42|=0.010
71930786|NCT00532779|143382529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.43|||||TWO_SIDED|||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||
71930787|NCT00532779|143382529|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.29|||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71930788|NCT00532779|143382530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.81|||||TWO_SIDED|95.0|-6.68|-0.94||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||-0.94|-6.68|
71930789|NCT00532779|143382530|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.84|||<|0.001|TWO_SIDED|95.0|-8.71|-2.98|||ANCOVA|||||-2.98|-8.71|<0.001
71930790|NCT00532779|143382531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-3.62|2.84||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.84|-3.62|
71930791|NCT00532779|143382531|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.13||||0.484|TWO_SIDED|95.0|-4.29|2.04|||ANCOVA|||||2.04|-4.29|0.484
71930792|NCT00532779|143382532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.23|||||TWO_SIDED|95.0|1.16|3.3||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||3.30|1.16|
71930793|NCT00532779|143382532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.83|||||TWO_SIDED|95.0|0.76|2.9||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||2.90|0.76|
71930794|NCT00532779|143382533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.96|||||TWO_SIDED|95.0|0.19|1.73||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.73|0.19|
71930795|NCT00532779|143382533|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9|||||TWO_SIDED|95.0|0.13|1.67||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.67|0.13|
71930796|NCT00532779|143382534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74|||||TWO_SIDED|95.0|0.19|1.28||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.28|0.19|
71930797|NCT00532779|143382534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||||TWO_SIDED|95.0|-0.09|1.0||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.00|-0.09|
71930798|NCT00532779|143382535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.69|||||TWO_SIDED|95.0|0.14|1.23||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||1.23|0.14|
71930799|NCT00532779|143382535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.4|0.69||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.69|-0.40|
71930800|NCT00532779|143382536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.53|0.53||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.53|-0.53|
71930801|NCT00532779|143382536|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-0.8|0.27||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.||0.27|-0.80|
71930802|NCT00689273|143382537|SUPERIORITY||Least Square (LS) Mean Difference|-0.49|STANDARD_ERROR_OF_MEAN|0.57||0.39|TWO_SIDED|80.0|-1.23|0.24|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect. One-sided alpha of 0.1 was used for the analysis.||0.24|-1.23|0.39
71930803|NCT00689273|143382538|SUPERIORITY||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.52||0.63|TWO_SIDED|80.0|-0.92|0.42|||Mixed Models Analysis|||Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.42|-0.92|0.63
71930804|NCT00689273|143382539|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.27||0.54|TWO_SIDED|80.0|-0.51|0.18|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.18|-0.51|0.54
71930805|NCT00689273|143382539|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.28||0.6|TWO_SIDED|80.0|-0.51|0.21|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.21|-0.51|0.60
71930806|NCT00689273|143382540|SUPERIORITY||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|1.8||0.44|TWO_SIDED|80.0|-3.69|0.94|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.94|-3.69|0.44
71930807|NCT00689273|143382540|SUPERIORITY||LS Mean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.0||0.23|TWO_SIDED|80.0|-5.0|0.16|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-5.00|0.23
71930808|NCT00689273|143382541|SUPERIORITY||LS Mean Difference|-1.76|STANDARD_ERROR_OF_MEAN|2.46||0.48|TWO_SIDED|80.0|-4.94|1.41|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||1.41|-4.94|0.48
71930809|NCT00689273|143382541|SUPERIORITY||LS Mean Difference|-3.02|STANDARD_ERROR_OF_MEAN|2.79||0.28|TWO_SIDED|80.0|-6.61|0.57|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.57|-6.61|0.28
71930810|NCT00689273|143382542|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.91||0.48|TWO_SIDED|80.0|-1.81|0.52|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.52|-1.81|0.48
71930811|NCT00689273|143382542|SUPERIORITY||LS Mean Difference|-1.12|STANDARD_ERROR_OF_MEAN|1.03||0.28|TWO_SIDED|80.0|-2.45|0.2|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.20|-2.45|0.28
71930812|NCT00689273|143382543|SUPERIORITY||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.19||0.28|TWO_SIDED|80.0|-0.46|0.04|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.04|-0.46|0.28
71930813|NCT00689273|143382543|SUPERIORITY||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.28||0.14|TWO_SIDED|80.0|-0.78|-0.06|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.06|-0.78|0.14
71930814|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.28||0.55|TWO_SIDED|80.0|-0.52|0.19|||Mixed Models Analysis|||Day 1: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.19|-0.52|0.55
71930815|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.81|-0.09|||Mixed Models Analysis|||Day 2: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.81|0.11
71930816|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.28||0.2|TWO_SIDED|80.0|-0.71|0.0|||Mixed Models Analysis|||Day 3: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.00|-0.71|0.20
71930817|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.23|TWO_SIDED|80.0|-0.69|0.02|||Mixed Models Analysis|||Day 4: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.02|-0.69|0.23
71930818|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_DEVIATION|0.28||0.41|TWO_SIDED|80.0|-0.58|0.13|||Mixed Models Analysis|||Day 5: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.13|-0.58|0.41
71930819|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.28||0.62|TWO_SIDED|80.0|-0.49|0.22|||Mixed Models Analysis|||Day 6: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.22|-0.49|0.62
71930820|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.28||0.49|TWO_SIDED|80.0|-0.55|0.16|||Mixed Models Analysis|||Day 7: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.16|-0.55|0.49
71930821|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.46|STANDARD_DEVIATION|0.28||0.1|TWO_SIDED|80.0|-0.81|-0.1|||Mixed Models Analysis|||Day 8: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.10|-0.81|0.10
71930822|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.69|0.03|||Mixed Models Analysis|||Day 9: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.69|0.24
71930823|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.65|STANDARD_ERROR_OF_MEAN|0.28||0.02|TWO_SIDED|80.0|-1.01|-0.28|||Mixed Models Analysis|||Day 10: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.28|-1.01|0.02
71930824|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.93|-0.21|||Mixed Models Analysis|||Day 11: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.21|-0.93|0.04
71930825|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.28||0.04|TWO_SIDED|80.0|-0.95|-0.23|||Mixed Models Analysis|||Day 12: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.23|-0.95|0.04
71930826|NCT00689273|143382544|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.24|TWO_SIDED|80.0|-0.7|0.03|||Mixed Models Analysis|||Day 13: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.03|-0.70|0.24
71930827|NCT00689273|143382544|SUPERIORITY||Slope|-0.45|STANDARD_ERROR_OF_MEAN|0.28||0.11|TWO_SIDED|80.0|-0.82|-0.09|||Mixed Models Analysis|||Day 14: Results were obtained from a mixed effect repeated measure model using compound symmetry covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||-0.09|-0.82|0.11
71930828|NCT00689273|143382545|SUPERIORITY|||||||0.22|||||||Cochran-Mantel-Haenszel|||30% Reduction||||0.22
71930829|NCT00689273|143382545|SUPERIORITY|||||||0.38|||||||Cochran-Mantel-Haenszel|||50% Reduction||||0.38
71930830|NCT00689273|143382546|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.45|TWO_SIDED|80.0|-0.27|0.07|||Mixed Models Analysis|||Week 1: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.07|-0.27|0.45
71690063|NCT03299101|142896452|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.15||0.757|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in SGA between day of surgery and 90 days postop.||||0.757
71690064|NCT03299101|142896453|SUPERIORITY|||||||0.362|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change in 6 Minute Walk Test across all 4 time points.||||0.362
71690065|NCT03299101|142896453|SUPERIORITY||Mean Difference (Net)|25.52|STANDARD_ERROR_OF_MEAN|20.06||0.203|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and day of surgery.||||.203
71930831|NCT00689273|143382546|SUPERIORITY||LS Mean Difference|-0.12|STANDARD_ERROR_OF_MEAN|0.13||0.37|TWO_SIDED|80.0|-0.29|0.05|||Mixed Models Analysis|||Week 2: Results were obtained from a mixed effect repeated measure model using unstructured covariance matrix. The model included random-effect terms for participant, and fixed-effect terms for baseline response, treatment group, time, treatment-by-time interaction, and country effect.||0.05|-0.29|0.37
71930832|NCT01556165|143382558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|1.32||0.0254|TWO_SIDED|75.0|-4.53|-1.47||No adjustments for multiple comparisons were made.|ANCOVA|||This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.||-1.47|-4.53|0.0254
71930833|NCT01556165|143382559|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.21||0.0032|TWO_SIDED|95.0|-1.03|-0.21|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||-0.21|-1.03|0.0032
71930834|NCT01556165|143382560|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.52||0.1963|TWO_SIDED|95.0|-1.7|0.35|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.35|-1.70|0.1963
71930835|NCT01556165|143382561|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71|STANDARD_ERROR_OF_MEAN|0.91||0.0641|TWO_SIDED|95.0|-3.52|0.1|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.||0.10|-3.52|0.0641
71930836|NCT01238172|143382564|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.76|TWO_SIDED|95.0|0.75|1.24|||Log Rank|||||1.24|0.75|0.76
71930837|NCT01238172|143382565|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.71|TWO_SIDED|95.0|0.23|8.41|||Log Rank|||||8.41|0.23|0.71
71930838|NCT01238172|143382566|SUPERIORITY|||||||0.995|||||||Wilcoxon (Mann-Whitney)|||||||0.995
71930839|NCT01238172|143382567|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|Two-sided||||||<0.001
71930840|NCT02787746|143382616|OTHER||Odds Ratio (OR)|0.988||||0.9744|TWO_SIDED|95.0|0.466|2.095|||Regression, Logistic|||Age (\>75y vs ≤75y）||2.095|0.466|0.9744
71930841|NCT02787746|143382616|OTHER||Odds Ratio (OR)|3.42||||0.3288|TWO_SIDED|95.0|0.29|40.354|||Regression, Logistic|||APOE ɛ4 (carrier vs non-carrier)||40.354|0.290|0.3288
71930842|NCT02787746|143382616|OTHER||Odds Ratio (OR)|2.107||||0.5732|TWO_SIDED|95.0|0.158|28.171|||Regression, Logistic|||Concomitant medication：Gastrointestinal drugs||28.171|0.158|0.5732
71930843|NCT02787746|143382616|OTHER||Odds Ratio (OR)|0.976||||0.9694|TWO_SIDED|95.0|0.281|3.387|||Regression, Logistic|||Concomitant medication：Hypoglycemic drugs||3.387|0.281|0.9694
71930844|NCT02787746|143382616|OTHER||Odds Ratio (OR)|2.221||||0.0396|TWO_SIDED|95.0|1.039|4.748|||Regression, Logistic|||Concomitant medication：Cardiovascular and Cerebrovascular drugs||4.748|1.039|0.0396
71930845|NCT02787746|143382616|OTHER||Odds Ratio (OR)|2.056||||0.5889|TWO_SIDED|95.0|0.151|28.074|||Regression, Logistic|||Concomitant medication：Hepatology drugs||28.074|0.151|0.5889
71930846|NCT02787746|143382616|OTHER||Odds Ratio (OR)|1.004||||0.1181|TWO_SIDED|95.0|0.999|1.008|||Regression, Logistic|||Duration of previous donepezil 5mg/d therapy (day)||1.008|0.999|0.1181
71930847|NCT04876482|143382626|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-10.76|||<|0.05|TWO_SIDED||||||Regression, Linear|||"We hypothesized that the improvements in the AHI would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).~."||||<0.05
71930848|NCT04876482|143382627|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.05|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the upper airway volume would be higher in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71930849|NCT04876482|143382628|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.275|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the minimal area on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls)||||<0.05
71930850|NCT04876482|143382629|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|-0.14|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the anteror to posterior distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71930851|NCT04876482|143382630|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the lateral distance on the tip of epiglottis would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71930852|NCT04876482|143382631|OTHER|Baseline characteristics among the study groups were compared using Fisher exact test for categorical variables. McNemar chi-square test used for within-group analysis.|Number and percentage|0.05|||<|0.05|TWO_SIDED||||||Fisher Exact|||We hypothesized that TORS followed by OPR would improve upper airway obstruction more compared with TORS alone and conservative treatment (control).||||<0.05
71930853|NCT04876482|143382632|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.23|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the jaw opening muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71930854|NCT04876482|143382633|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|2.45|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue protrusion muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71930855|NCT04876482|143382634|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|4.81|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue elevation muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71930856|NCT04876482|143382635|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|7.01|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue depression muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71690066|NCT03299101|142896453|SUPERIORITY||Mean Difference (Net)|12.7|STANDARD_ERROR_OF_MEAN|13.77||0.357|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between baseline and 90 days postop.||||0.357
71690067|NCT03299101|142896453|SUPERIORITY||Mean Difference (Net)|21.48|STANDARD_ERROR_OF_MEAN|15.4||0.163|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<0.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in 6 Minute Walk Test between day of surgery and 90 days postop.||||0.163
71690068|NCT03299101|142896454|SUPERIORITY|||||||0.068|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across all 4 time points.||||0.068
71690069|NCT03299101|142896454|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.02||0.043|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and day of surgery.||||0.043
71690070|NCT03299101|142896454|SUPERIORITY||Mean Difference (Net)|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.092|TWO_SIDED|||||The null hypothesis was rejected a priori if p\<.05.|Mixed Models Analysis||The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change between baseline and 90 days postop.||||0.092
71690071|NCT03299101|142896454|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.02||0.292|TWO_SIDED||||||Mixed Models Analysis|The null hypothesis was rejected a priori if p\<.05.|The mean within-person difference was assessed with linear mixed models with standard error and p-value similar to paired t-tests.|Linear mixed models estimated within-person change in mean MEP between day of surgery and 90 days postop.||||0.292
71690072|NCT03299101|142896455|SUPERIORITY|||||||0.625|||||||Mixed Models Analysis|||Linear mixed models estimated overall, within-person change across both time points.||||0.625
71690073|NCT01100723|142896456|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71690074|NCT01100723|142896457|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||<0.05
71690075|NCT01100723|142896458|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71930857|NCT04876482|143382636|OTHER|The Overall Number of Participants Analyzed do not appear to be equal, so we used linear regrssion to compare the mean difference among three groups.|Mean Difference (Final Values)|3.67|||<|0.05|TWO_SIDED||||||Regression, Linear|||We hypothesized that the improvements in the tongue lateralization muscle strength would be more in patients who underwent TORS combined with OPR than in those who underwent only TORS and those who received conservative treatment (controls).||||<0.05
71690076|NCT01100723|142896459|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71690077|NCT01100723|142896460|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71690078|NCT01100723|142896461|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||McNemar|||Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.||||< 0.05
71690079|NCT03066778|142896467|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.00069|TWO_SIDED|95.0|0.6|0.88|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.88|0.60|0.00069
71690080|NCT03066778|142896468|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.01643|TWO_SIDED|95.0|0.64|0.98|||Log Rank|One-sided p-value based on log-rank test stratified by platinum chemotherapy, ECOG, and LDH|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by platinum chemotherapy, ECOG, and LDH|||0.98|0.64|0.01643
71690081|NCT03066778|142896469|SUPERIORITY||Percent Difference|8.9||||0.0227|TWO_SIDED|95.0|0.2|17.4|||Miettinen & Nurminen|One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent \> 0.|Based on Miettinen \& Nurminen method stratified by platinum chemotherapy, ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||17.4|0.2|0.02270
71690082|NCT03066778|142896474|OTHER||Difference in Least Square Means|4.43||||0.04|TWO_SIDED|95.0|0.21|8.66|||Log Rank|||||8.66|0.21|0.040
71930858|NCT02007369|143382644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.033|TWO_SIDED|95.0|0.05|0.89|||Regression, Logistic|||||0.89|0.05|0.033
71930859|NCT02007369|143382644|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.934|TWO_SIDED|95.0|0.36|3.01|||Regression, Logistic|||||3.01|0.36|0.934
71930860|NCT02007369|143382645|SUPERIORITY_OR_OTHER|||||||0.002|||||||Fisher Exact|||||||0.002
71690083|NCT03066778|142896477|OTHER||Hazard Ratio (HR)|0.8||||0.208|TWO_SIDED|95.0|0.56|1.14|||Log Rank|Two-sided p-value based on stratified log-rank test|Based on Cox regression model with treatment as a covariate stratified by platinum chemotherapy ECOG, and LDH. Cisplatin, ECOG 0, LDH ≤ULN and Cisplatin, ECOG 0, LDH \>ULN were combined into one stratum because of small sample size|||1.14|0.56|0.208
71690084|NCT03665077|142896485|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.684
71690085|NCT03665077|142896486|OTHER|Linear mixed-effect model of log-transformed oxylipin level, with time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.02
71930861|NCT02007369|143382645|SUPERIORITY_OR_OTHER|||||||0.199|||||||Fisher Exact|||||||0.199
71930862|NCT02007369|143382646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.285|TWO_SIDED|95.0|0.25|1.5|||Regression, Logistic|||||1.50|0.25|0.285
71930863|NCT02007369|143382646|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.597|TWO_SIDED|95.0|0.31|1.97|||Regression, Logistic|||||1.97|0.31|0.597
71930864|NCT02007369|143382647|SUPERIORITY_OR_OTHER|||||||0.023|||||||Fisher Exact|||||||0.023
71930865|NCT02007369|143382647|SUPERIORITY_OR_OTHER|||||||0.527|||||||Fisher Exact|||||||0.527
71930866|NCT02253654|143382665|SUPERIORITY_OR_OTHER||Treatment difference|0.39|STANDARD_ERROR_OF_MEAN|3.53||0.46|ONE_SIDED|97.5|-6.58||||t-test, 1 sided|||The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.|||-6.58|0.46
71930867|NCT00069160|143382675|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||t-test, 2 sided|||||||>.05
71930868|NCT02576054|143382710|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.25|||<|0.001|TWO_SIDED|95.0|1.0|1.57|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 6||1.57|1.00|<0.001
71930869|NCT02576054|143382710|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|2.3|||<|0.001|TWO_SIDED|95.0|1.89|2.78|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio = GMT PN200 divided by GMT PN122|Anti-HPV 11||2.78|1.89|<0.001
71930870|NCT02576054|143382710|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.69|||<|0.001|TWO_SIDED|95.0|1.35|2.11|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 16||2.11|1.35|<0.001
71930871|NCT02576054|143382710|NON_INFERIORITY|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|3.05|||<|0.001|TWO_SIDED|95.0|2.33|3.99|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 18||3.99|2.33|<0.001
71930872|NCT01190098|143382715|NON_INFERIORITY_OR_EQUIVALENCE|Null hypothesis: there is a non-inferiority region of 4 points.||||||0.027|||||||t-test, 1 sided|||||||0.027
71930873|NCT01190098|143382716|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.7||||0.23|TWO_SIDED||||||t-test, 2 sided|||||||0.23
71930874|NCT01190098|143382717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.84|TWO_SIDED||||||t-test, 2 sided|||||||0.84
71930875|NCT01190098|143382718|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.37|TWO_SIDED||||||t-test, 2 sided|||||||0.37
71930876|NCT01190098|143382719|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.8||||0.33|TWO_SIDED||||||t-test, 2 sided|||||||0.33
71930877|NCT01190098|143382720|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.92|TWO_SIDED||||||t-test, 2 sided|||||||0.92
71930878|NCT01190098|143382721|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0||||0.69|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.69
71930879|NCT01190098|143382722|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.95|TWO_SIDED||||||t-test, 2 sided|||||||0.95
71930880|NCT02957682|143382723|NON_INFERIORITY|Upper confidence interval (CI) limit was compared to the noninferiority margin, which was 0.2%, and noninferiority was declared if the upper CI limit was below the noninferiority margin.|Least Square (LS) Mean Difference|-0.02||||0.6055|TWO_SIDED|95.0|-0.094|0.055||P-value was taken from mixed-effect model with repeated measures (MMRM) analysis.|Mixed-effect Model Repeated Measures||Model: fixed categorical effects of treatment group, randomization strata as per IVRS, time point, treatment-by-time point, strata-by-time point, continuous fixed covariates of baseline SWMS raw score value, baseline value by time-point interaction.|Change at Week 96||0.055|-0.094|0.6055
71930881|NCT02499406|143382740|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||>0.016
71930882|NCT02499406|143382741|SUPERIORITY||||||<|0.016||||||p value was calculated and found to be below the a priori threshold for significance, which was adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||<0.016
71690086|NCT03665077|142896487|OTHER|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058|||||||Mixed Models Analysis|Linear mixed-effect model of log-transformed oxylipin level: time (date) as a continuous variable, adjusted for batch and clustered on participant||||||0.058
71690087|NCT02420262|142896492|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D \<0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).|Treatment contrast|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.16|0.12|||Mixed Models Analysis|||Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.||0.12|-0.16|<0.0001
71690088|NCT02420262|142896493|SUPERIORITY_OR_OTHER||Treatment ratio|0.11|||<|0.0001|TWO_SIDED|95.0|0.08|0.17|||Negative binomial regression model||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0.|Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||0.17|0.08|<0.0001
71930883|NCT02499406|143382742|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
71930884|NCT02499406|143382743|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=14||Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessment||||<0.016
71930885|NCT02499406|143382744|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=10||Null hypothesis is no difference between baseline and this 6-month assessment.||||<0.016
71930886|NCT02499406|143382745|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=11||Null hypothesis is no difference between baseline and this 9-month assessment.||||<0.016
71930887|NCT02499406|143382746|SUPERIORITY||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.||||> 0.016
71930888|NCT02499406|143382747|SUPERIORITY||||||=|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=10||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.||||=.016
71930889|NCT02499406|143382748|SUPERIORITY||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.||||<0.016
71930890|NCT00390949|143382782|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjustments for community pair, age-group and value of variable at baseline||||||<0.05
71930891|NCT00390949|143382783|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value of variable at baseline||||||<0.05
71930892|NCT00390949|143382784|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|||||||<0.05
71930893|NCT00390949|143382785|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
71930894|NCT00390949|143382786|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair and age-group||||||<0.05
71930895|NCT00390949|143382787|SUPERIORITY||||||<|0.05||||||The p-value reported above is not simply a statement of the threshold for significance used in the study. The p-value for this comparison was calculated at the time of the study and was found to be less than 0.5.|Regression, Logistic|Adjusted for community pair, age-group and value at baseline||||||<0.05
71930896|NCT00038467|143382813|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||3e-05|TWO_SIDED|95.0|0.58|0.82|||Log Rank|||||0.82|0.58|0.00003
71930897|NCT00038467|143382814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.913||||0.15737|TWO_SIDED|95.0|0.806|1.036|||Log Rank|||||1.036|0.806|0.15737
71930898|NCT00038467|143382816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|||<|0.0001|TWO_SIDED|95.0|1.63|3.23|||t-test, 2 sided|||6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.23|1.63|<0.0001
71930899|NCT00038467|143382816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.18||||0.0002|TWO_SIDED|95.0|0.57|1.79|||t-test, 2 sided|||6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||1.79|0.57|0.0002
71930900|NCT00038467|143382816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.79|||<|0.0001|TWO_SIDED|95.0|1.77|3.81|||t-test, 2 sided|||12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||3.81|1.77|<0.0001
71930901|NCT00038467|143382816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.79|||<|0.0001|TWO_SIDED|95.0|1.12|2.46|||t-test, 2 sided|||12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.46|1.12|<0.0001
71930902|NCT00038467|143382816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|||<|0.0001|TWO_SIDED|95.0|2.1|4.35|||t-test, 2 sided|||24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.||4.35|2.10|<0.0001
71930903|NCT00038467|143382816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|||<|0.0001|TWO_SIDED|95.0|1.1|2.69|||t-test, 2 sided|||24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.||2.69|1.10|<0.0001
71930904|NCT00038467|143382825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.5|TWO_SIDED|95.0|-1.76|0.86|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.86|-1.76|0.500
71930905|NCT00038467|143382825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.009|TWO_SIDED|95.0|-3.67|-0.52|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.52|-3.67|0.009
71930906|NCT00038467|143382825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.35||||0.079|TWO_SIDED|95.0|-2.86|0.16|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.16|-2.86|0.079
71930907|NCT00038467|143382825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.729|TWO_SIDED|95.0|-1.24|1.77|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.77|-1.24|0.729
71930908|NCT00038467|143382825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84||||0.302|TWO_SIDED|95.0|-2.43|0.75|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.75|-2.43|0.302
71930909|NCT00038467|143382825|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.187|TWO_SIDED|95.0|-2.76|0.54|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.54|-2.76|0.187
71930910|NCT00038467|143382826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.26|TWO_SIDED|95.0|-1.8|0.49|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.49|-1.80|0.260
71930911|NCT00038467|143382826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79||||0.209|TWO_SIDED|95.0|-2.02|0.44|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.44|-2.02|0.209
71930912|NCT00038467|143382826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.698|TWO_SIDED|95.0|-1.38|0.92|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.92|-1.38|0.698
71930913|NCT00038467|143382826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.83||||0.192|TWO_SIDED|95.0|-0.42|2.09|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||2.09|-0.42|0.192
71930914|NCT00038467|143382826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.813|TWO_SIDED|95.0|-1.46|1.15|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||1.15|-1.46|0.813
71930915|NCT00038467|143382826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42||||0.537|TWO_SIDED|95.0|-0.91|1.75|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||1.75|-0.91|0.537
71930916|NCT00038467|143382827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.727|TWO_SIDED|95.0|-3.46|2.42|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||2.42|-3.46|0.727
71930917|NCT00038467|143382827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08||||0.047|TWO_SIDED|95.0|-6.12|-0.05|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.05|-6.12|0.047
71930918|NCT00038467|143382827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.553|TWO_SIDED|95.0|-3.88|2.08|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||2.08|-3.88|0.553
71930919|NCT00038467|143382827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.91||||0.563|TWO_SIDED|95.0|-2.17|3.99|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||3.99|-2.17|0.563
71930920|NCT00038467|143382827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.73||||0.643|TWO_SIDED|95.0|-3.83|2.36|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||2.36|-3.83|0.643
71930921|NCT00038467|143382827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.91||||0.126|TWO_SIDED|95.0|-6.63|0.82|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.82|-6.63|0.126
71930922|NCT00038467|143382828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.265|TWO_SIDED|95.0|-0.83|0.23|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.23|-0.83|0.265
71930923|NCT00038467|143382828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.21||||0.0002|TWO_SIDED|95.0|-1.84|-0.57|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||-0.57|-1.84|0.0002
71930924|NCT00038467|143382828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.132|TWO_SIDED|95.0|-1.0|0.13|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.13|-1.00|0.132
71930925|NCT00038467|143382828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.635|TWO_SIDED|95.0|-0.7|0.43|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.43|-0.70|0.635
71930926|NCT00038467|143382828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.449|TWO_SIDED|95.0|-0.75|0.33|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.33|-0.75|0.449
71930927|NCT00038467|143382828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.454|TWO_SIDED|95.0|-0.81|0.36|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.36|-0.81|0.454
71930928|NCT00038467|143382829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.712|TWO_SIDED|95.0|-0.53|0.335|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.335|-0.53|0.712
71930929|NCT00038467|143382829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.899|TWO_SIDED|95.0|-0.65|0.356|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.356|-0.65|0.899
71930930|NCT00038467|143382829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.882|TWO_SIDED|95.0|-0.76|0.359|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.359|-0.76|0.882
71930931|NCT00038467|143382829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.604|TWO_SIDED|95.0|-0.54|0.37|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.37|-0.54|0.604
71930932|NCT00038467|143382829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.562|TWO_SIDED|95.0|-1.16|0.454|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.454|-1.16|0.562
71930933|NCT00038467|143382830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.892|TWO_SIDED|95.0|-0.2|0.18|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.18|-0.20|0.892
71930934|NCT00038467|143382830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.881|TWO_SIDED|95.0|-0.21|0.24|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.24|-0.21|0.881
71930935|NCT00038467|143382830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.883|TWO_SIDED|95.0|-0.18|0.21|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.21|-0.18|0.883
71930936|NCT00038467|143382830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.604|TWO_SIDED|95.0|-0.16|0.27|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.27|-0.16|0.604
71930937|NCT00038467|143382830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.118|TWO_SIDED|95.0|-0.05|0.41|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.41|-0.05|0.118
71930938|NCT00038467|143382830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.307|TWO_SIDED|95.0|-0.11|0.34|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.34|-0.11|0.307
71930939|NCT00038467|143382831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.792|TWO_SIDED|95.0|-0.42|0.56|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.56|-0.42|0.792
71930940|NCT00038467|143382831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.405|TWO_SIDED|95.0|-0.76|0.31|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.31|-0.76|0.405
71930941|NCT00038467|143382831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.484|TWO_SIDED|95.0|-0.75|0.36|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.36|-0.75|0.484
71930942|NCT00038467|143382831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.229|TWO_SIDED|95.0|-0.19|0.8|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.80|-0.19|0.229
71930943|NCT00038467|143382831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.381|TWO_SIDED|95.0|-0.84|0.32|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.32|-0.84|0.381
71930944|NCT00038467|143382831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.405|TWO_SIDED|95.0|-0.82|0.33|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.33|-0.82|0.405
71930945|NCT00038467|143382832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.648|TWO_SIDED|95.0|-0.77|0.48|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.48|-0.77|0.648
71930946|NCT00038467|143382832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.366|TWO_SIDED|95.0|-1.08|0.4|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.40|-1.08|0.366
71930947|NCT00038467|143382832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.062|TWO_SIDED|95.0|-1.33|0.03|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.03|-1.33|0.062
71930948|NCT00038467|143382832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.545|TWO_SIDED|95.0|-0.53|1.0|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||1.00|-0.53|0.545
71930949|NCT00038467|143382832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.932|TWO_SIDED|95.0|-0.77|0.7|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.70|-0.77|0.932
71930950|NCT00038467|143382832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.244|TWO_SIDED|95.0|-1.24|0.32|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.32|-1.24|0.244
71930951|NCT00038467|143382833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.876|TWO_SIDED|95.0|-0.62|0.73|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.||0.73|-0.62|0.876
71930952|NCT00038467|143382833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.195|TWO_SIDED|95.0|-1.25|0.26|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.||0.26|-1.25|0.195
71930953|NCT00038467|143382833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.63|TWO_SIDED|95.0|-0.92|0.55|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.||0.55|-0.92|0.630
71930954|NCT00038467|143382833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.53|TWO_SIDED|95.0|-0.5|0.98|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.||0.98|-0.50|0.530
71930955|NCT00038467|143382833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.147|TWO_SIDED|95.0|-1.43|0.21|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.||0.21|-1.43|0.147
71930956|NCT00038467|143382833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.389|TWO_SIDED|95.0|-1.18|0.46|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.||0.46|-1.18|0.389
71930957|NCT00038467|143382835|SUPERIORITY_OR_OTHER|||||||0.0174|TWO_SIDED||||||Chi-squared|||6 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0174
71930958|NCT00038467|143382835|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Chi-squared|||12 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0059
71930959|NCT00038467|143382835|SUPERIORITY_OR_OTHER|||||||0.0037|TWO_SIDED||||||Chi-squared|||24 months: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.0037
71930960|NCT00038467|143382835|SUPERIORITY_OR_OTHER|||||||0.8084|TWO_SIDED||||||Chi-squared|||12 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.8084
71930961|NCT00038467|143382835|SUPERIORITY_OR_OTHER|||||||0.6449|TWO_SIDED||||||Chi-squared|||24 months post-treatment: p-value for percentage of participants with an endometrial thickness of \>=5 mm was analyzed using Chi-squared test.||||0.6449
71930962|NCT01988493|143382843|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.46||||0.0087|TWO_SIDED|90.0|0.28|0.76|||Log Rank|||||0.76|0.28|0.0087
71930963|NCT01988493|143382844|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.53||||0.0229||90.0|0.33|0.84|||Log Rank|||||0.84|0.33|0.0229
71930964|NCT01988493|143382845|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.71||||0.2333||90.0|0.45|1.14|||Log Rank|||||1.14|0.45|0.2333
71930965|NCT01988493|143382846|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.45||||0.0059||90.0|0.28|0.73|||Log Rank|||||0.73|0.28|0.0059
71930966|NCT01988493|143382859|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|1.04||||0.8915||90.0|0.62|1.77|||Log Rank|||||1.77|0.62|0.8915
71930967|NCT01988493|143382860|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0438|||||||Cochran-Mantel-Haenszel|||||||0.0438
71930968|NCT01988493|143382862|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.59||||0.0496|TWO_SIDED|90.0|0.38|0.92|||Log Rank|||||0.92|0.38|0.0496
71930969|NCT01988493|143382863|EQUIVALENCE|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0527|||||||Cochran-Mantel-Haenszel|||||||0.0527
71930970|NCT02617446|143382908|SUPERIORITY||Mean Difference (Final Values)|-3.0||||0.029|TWO_SIDED|95.0|-5.68|-0.32||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.32|-5.68|0.029
71930971|NCT02617446|143382908|SUPERIORITY||Mean Difference (Final Values)|-2.08||||0.009|TWO_SIDED|95.0|-3.61|-0.55||Alpha set at 0.05.|ANOVA|Treatment term included in the model||Null hypothesis: No difference in E/Ea ratio between istaroxime and placebo||-0.55|-3.61|0.009
71930972|NCT02617446|143382909|SUPERIORITY||Mean Difference (Final Values)|1.7632||||0.089|TWO_SIDED|95.0|-0.2751|3.8014||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.8014|-0.2751|0.089
71930973|NCT02617446|143382909|SUPERIORITY||Mean Difference (Final Values)|0.9848||||0.423|TWO_SIDED|95.0|-1.4668|3.4365||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term included in the model||Null hypothesis: No difference in LVEF % between istaroxime and placebo participants.||3.4365|-1.4668|0.423
71930974|NCT02617446|143382910|SUPERIORITY||Mean Difference (Final Values)|3.684||||0.034|TWO_SIDED|95.0|0.285|7.083||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in SVI between istaroxime and placebo participants.||7.083|0.285|0.034
71930975|NCT02617446|143382910|SUPERIORITY||Mean Difference (Final Values)|2.31||||0.09|TWO_SIDED|95.0|-0.373|4.992||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.992|-0.373|0.090
71930976|NCT02617446|143382911|SUPERIORITY||Mean Difference (Final Values)|-0.777||||0.042|TWO_SIDED|95.0|-1.522|-0.032||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is included in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.032|-1.522|0.042
71930977|NCT02617446|143382911|SUPERIORITY||Mean Difference (Final Values)|-0.829||||0.029|TWO_SIDED|95.0|-1.568|-0.091||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||-0.091|-1.568|0.029
71930978|NCT02617446|143382912|SUPERIORITY||Mean Difference (Final Values)|-5.368||||0.11|TWO_SIDED|95.0|-11.999|1.262||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVESV between istaroxime and placebo participants.||1.262|-11.999|0.110
71930979|NCT02617446|143382912|SUPERIORITY||Mean Difference (Final Values)|0.439||||0.931|TWO_SIDED|95.0|-9.735|10.614||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model||Null hypothesis: No difference in LVEDV between istaroxime and placebo participants.||10.614|-9.735|0.931
71930980|NCT02617446|143382913|SUPERIORITY||Mean Difference (Final Values)|-1.657||||0.589|TWO_SIDED|95.0|-7.777|4.461||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term in the model||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||4.461|-7.777|0.589
71690089|NCT02420262|142896494|SUPERIORITY_OR_OTHER||Treatment difference|-3.57|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.95|||Mixed Models Analysis||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero.|Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.||-2.95|-4.19|<0.0001
71930981|NCT02617446|143382913|SUPERIORITY||Mean Difference (Final Values)|3.944||||0.424|TWO_SIDED|95.0|-5.886|13.774||Alpha set at 0.05. No adjustment for multiple comparisons|ANOVA|Treatment term is in the model.||Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants.||13.774|-5.886|0.424
71930982|NCT02617446|143382914|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|-0.041||||0.987|TWO_SIDED|95.0|-5.216|5.133||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups||5.133|-5.216|0.987
71930983|NCT02617446|143382914|SUPERIORITY|Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment\*timepoint interaction included in the model.|Mean Difference (Final Values)|3.015||||0.251|TWO_SIDED|95.0|-2.168|8.198||Unadjusted alpha of 0.05 is the threshold for statistical significance.|Mixed Models Analysis|Kenward-Roger adjustment used for the degrees of freedom.||Null hypothesis: no difference between treatment groups.||8.198|-2.168|0.251
71930984|NCT00865306|143382954|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared|||||||<.05
71930985|NCT00865306|143382955|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Chi-squared|||||||<.01
71930986|NCT01652872|143382973|OTHER||Treatment Difference|-0.27|||||TWO_SIDED|95.0|-6.39|5.85|||||Difference is fixed dose - titration.|||5.85|-6.39|
71930987|NCT01652872|143382973|OTHER||Risk Ratio (RR)|0.998|||||TWO_SIDED|95.0|0.776|1.285|||Cochran-Mantel-Haenszel|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|A risk ratio \< 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.|||1.285|0.776|
71930988|NCT01652872|143382974|OTHER|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.|Least Squares Mean (LSM) Ratio|1.28|||||TWO_SIDED|95.0|0.81|2.05|||Negative binomial regression model||Least Squares Mean (LSM) ratio is fixed dose relative to titration.|||2.05|0.81|
71930989|NCT01652872|143382975|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.76|1.35|||Cox Proportional Hazard Model|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology).|Hazard ratio is fixed dose relative to titration.|||1.35|0.76|
71930990|NCT01652872|143382976|OTHER||Median of the difference|-0.34|||||TWO_SIDED|95.0|-0.46|-0.22|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-0.22|-0.46|
71930991|NCT01652872|143382977|OTHER||Median of the difference|-22.1|||||TWO_SIDED|95.0|-26.1|-18.1|||Hodges-Lehmann estimate||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.|-18.1|-26.1|
71690090|NCT01904032|142896499|SUPERIORITY||Mean Difference (Final Values)|0.7982|STANDARD_ERROR_OF_MEAN|2.0537||0.6982|TWO_SIDED|95.0|-3.2691|4.8656|||t-test, 2 sided|||The null hypothesis is that there is no difference in the CES-D change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||4.8656|-3.2691|.6982
71930992|NCT04529096|143382978|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.1|1.14|||Bayesian Mixed Model Analysis|||||1.14|-0.10|
71930993|NCT04529096|143382979|SUPERIORITY||Posterior Mean Difference|1.05|||||TWO_SIDED|95.0|-0.46|2.56|||Bayesian Mixed Model Analysis|||||2.56|-0.46|
71930994|NCT04529096|143382980|SUPERIORITY||Posterior Mean Difference|0.16|||||TWO_SIDED|95.0|-0.25|0.58|||Bayesian Mixed Model Analysis|||||0.58|-0.25|
71930995|NCT04529096|143382981|SUPERIORITY||Posterior Mean Difference|0.48|||||TWO_SIDED|95.0|-0.19|1.17|||Bayesian Mixed Model Analysis|||||1.17|-0.19|
71930996|NCT04529096|143382982|SUPERIORITY||Posterior Mean Difference|4.63|||||TWO_SIDED|95.0|-3.51|12.59|||Bayesian Mixed Model Analysis|||||12.59|-3.51|
71930997|NCT04529096|143382983|SUPERIORITY||Posterior Mean Difference|0.05|||||TWO_SIDED|95.0|-0.4|0.51|||Bayesian Mixed Model Analysis|||||0.51|-0.40|
71930998|NCT04529096|143382984|SUPERIORITY||Posterior Mean Difference|-15.18|||||TWO_SIDED|95.0|-206.43|175.8|||Bayesian Mixed Model Analysis|||||175.80|-206.43|
71930999|NCT04529096|143382985|SUPERIORITY||Posterior Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.11|0.01|||Bayesian Mixed Model Analysis|||||0.01|-0.11|
71931000|NCT03985293|143383012|SUPERIORITY||Difference in LS Mean|-0.47||||0.0071|TWO_SIDED|90.0|-0.76|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.76|0.0071
71931001|NCT03985293|143383012|SUPERIORITY||Difference in LS Mean|-0.9|||<|0.0001|TWO_SIDED|90.0|-1.18|-0.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.62|-1.18|<.0001
71931002|NCT03985293|143383012|SUPERIORITY||Difference in LS Mean|-1.01|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.73|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.73|-1.30|<.0001
71931003|NCT03985293|143383012|SUPERIORITY||Difference in LS Mean|-0.94|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.65|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.65|-1.24|<.0001
71931004|NCT03985293|143383012|SUPERIORITY||Difference in LS Mean|-1.16|||<|0.0001|TWO_SIDED|90.0|-1.47|-0.86|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.86|-1.47|<.0001
71931005|NCT03985293|143383013|SUPERIORITY||Odds Ratio (OR)|5.11|||||TWO_SIDED|90.0|1.84|14.18|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||14.18|1.84|
71931006|NCT03985293|143383013|SUPERIORITY||Odds Ratio (OR)|16.85|||||TWO_SIDED|90.0|6.18|45.93|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||45.93|6.18|
71931007|NCT03985293|143383013|SUPERIORITY||Odds Ratio (OR)|18.79|||||TWO_SIDED|90.0|7.03|50.21|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||50.21|7.03|
71931008|NCT03985293|143383013|SUPERIORITY||Odds Ratio (OR)|23.97|||||TWO_SIDED|90.0|8.66|66.39|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||66.39|8.66|
71931009|NCT03985293|143383013|SUPERIORITY||Odds Ratio (OR)|24.46|||||TWO_SIDED|90.0|8.72|68.57|||Regression, Logistic||The Odds ratio model included multiple imputation. PF-06882961 = Test Placebo = Reference|||68.57|8.72|
71931010|NCT03985293|143383014|SUPERIORITY||Difference in LS Mean|-0.09||||0.1578|TWO_SIDED|90.0|-0.19|0.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.01|-0.19|0.1578
71931011|NCT03985293|143383014|SUPERIORITY||Difference in LS Mean|-0.22||||0.0003|TWO_SIDED|90.0|-0.32|-0.12|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.12|-0.32|0.0003
71931012|NCT03985293|143383014|SUPERIORITY||Difference in LS Mean|-0.2||||0.0013|TWO_SIDED|90.0|-0.3|-0.1|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.10|-0.30|0.0013
71931013|NCT03985293|143383014|SUPERIORITY||Difference in LS Mean|-0.24||||0.0001|TWO_SIDED|90.0|-0.34|-0.14|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.14|-0.34|0.0001
71931014|NCT03985293|143383014|SUPERIORITY||Difference in LS Mean|-0.26|||<|0.0001|TWO_SIDED|90.0|-0.36|-0.16|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.16|-0.36|<.0001
71931015|NCT03985293|143383015|SUPERIORITY||Difference in LS Mean|-0.3||||0.0013|TWO_SIDED|90.0|-0.46|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.46|0.0013
71931016|NCT03985293|143383015|SUPERIORITY||Difference in LS Mean|-0.43|||<|0.0001|TWO_SIDED|90.0|-0.58|-0.28|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.28|-0.58|<.0001
71931017|NCT03985293|143383015|SUPERIORITY||Difference in LS Mean|-0.55|||<|0.0001|TWO_SIDED|90.0|-0.7|-0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.40|-0.70|<.0001
71931018|NCT03985293|143383015|SUPERIORITY||Difference in LS Mean|-0.5|||<|0.0001|TWO_SIDED|90.0|-0.66|-0.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.35|-0.66|<.0001
71931019|NCT03985293|143383015|SUPERIORITY||Difference in LS Mean|-0.56|||<|0.0001|TWO_SIDED|90.0|-0.71|-0.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.41|-0.71|<.0001
71931020|NCT03985293|143383016|SUPERIORITY||Difference in LS Mean|-0.4||||0.0004|TWO_SIDED|90.0|-0.59|-0.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.22|-0.59|0.0004
71931021|NCT03985293|143383016|SUPERIORITY||Difference in LS Mean|-0.64|||<|0.0001|TWO_SIDED|90.0|-0.81|-0.46|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.46|-0.81|<.0001
71931022|NCT03985293|143383016|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
71931023|NCT03985293|143383016|SUPERIORITY||Difference in LS Mean|-0.72|||<|0.0001|TWO_SIDED|90.0|-0.91|-0.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.53|-0.91|<.0001
71931024|NCT03985293|143383016|SUPERIORITY||Difference in LS Mean|-0.77|||<|0.0001|TWO_SIDED|90.0|-0.95|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-0.95|<.0001
71931025|NCT03985293|143383017|SUPERIORITY||Difference in LS Mean|-0.37||||0.0054|TWO_SIDED|90.0|-0.59|-0.15|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.15|-0.59|0.0054
71931026|NCT03985293|143383017|SUPERIORITY||Difference in LS Mean|-0.65|||<|0.0001|TWO_SIDED|90.0|-0.86|-0.44|||Mixed Models Analysis||PF-06882961 = Test Placebo = Reference|||-0.44|-0.86|<.0001
71931027|NCT03985293|143383017|SUPERIORITY||Difference in LS Mean|-0.84|||<|0.0001|TWO_SIDED|90.0|-1.06|-0.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.63|-1.06|<.0001
71931028|NCT03985293|143383017|SUPERIORITY||Difference in LS Mean|-0.8|||<|0.0001|TWO_SIDED|90.0|-1.02|-0.57|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.57|-1.02|<.0001
71931029|NCT03985293|143383017|SUPERIORITY||Difference in LS Mean|-0.89|||<|0.0001|TWO_SIDED|90.0|-1.11|-0.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.67|-1.11|<.0001
71931030|NCT03985293|143383018|SUPERIORITY||Difference in LS Mean|-0.44||||0.0061|TWO_SIDED|90.0|-0.71|-0.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.18|-0.71|0.0061
71931031|NCT03985293|143383018|SUPERIORITY||Difference in LS Mean|-0.79|||<|0.0001|TWO_SIDED|90.0|-1.05|-0.54|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.54|-1.05|<.0001
71931032|NCT03985293|143383018|SUPERIORITY||Difference in LS Mean|-0.98|||<|0.0001|TWO_SIDED|90.0|-1.24|-0.72|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.72|-1.24|<.0001
71931033|NCT03985293|143383018|SUPERIORITY||Difference in LS Mean|-0.83|||<|0.0001|TWO_SIDED|90.0|-1.1|-0.56|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.56|-1.10|<.0001
71931034|NCT03985293|143383018|SUPERIORITY||Difference in LS Mean|-1.03|||<|0.0001|TWO_SIDED|90.0|-1.3|-0.75|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.75|-1.30|<.0001
71931035|NCT03985293|143383019|SUPERIORITY||Difference in LS Mean|-17.13||||0.0014|TWO_SIDED|90.0|-25.94|-8.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-8.33|-25.94|0.0014
71931036|NCT03985293|143383019|SUPERIORITY||Difference in LS Mean|-16.38||||0.0021|TWO_SIDED|90.0|-25.08|-7.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|Difference in LS Mean|||-7.67|-25.08|0.0021
71931037|NCT03985293|143383019|SUPERIORITY||Difference in LS Mean|-22.2|||<|0.0001|TWO_SIDED|90.0|-30.88|-13.53|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-13.53|-30.88|<.0001
71931038|NCT03985293|143383019|SUPERIORITY||Difference in LS Mean|-18.59||||0.0006|TWO_SIDED|90.0|-27.43|-9.76|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.76|-27.43|0.0006
71931039|NCT03985293|143383019|SUPERIORITY||Difference in LS Mean|-25.33|||<|0.0001|TWO_SIDED|90.0|-34.0|-16.67|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-16.67|-34.00|<.0001
71931040|NCT03985293|143383020|SUPERIORITY||Difference in LS Mean|-11.79||||0.0468|TWO_SIDED|90.0|-21.55|-2.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.04|-21.55|0.0468
71931041|NCT03985293|143383020|SUPERIORITY||Difference in LS Mean|-18.68||||0.0012|TWO_SIDED|90.0|-28.12|-9.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-9.25|-28.12|0.0012
71931042|NCT03985293|143383020|SUPERIORITY||Difference in LS Mean|-27.44|||<|0.0001|TWO_SIDED|90.0|-37.03|-17.85|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.85|-37.03|<.0001
71931043|NCT03985293|143383020|SUPERIORITY||Difference in LS Mean|-27.36|||<|0.0001|TWO_SIDED|90.0|-37.22|-17.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.51|-37.22|<.0001
71931044|NCT03985293|143383020|SUPERIORITY||Difference in LS Mean|-28.09|||<|0.0001|TWO_SIDED|90.0|-37.72|-18.45|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-18.45|-37.72|<.0001
71931045|NCT03985293|143383021|SUPERIORITY||Difference in LS Mean|-15.9||||0.0091|TWO_SIDED|90.0|-25.9|-5.9|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-5.90|-25.90|0.0091
71931046|NCT03985293|143383021|SUPERIORITY||Difference in LS Mean|-25.53|||<|0.0001|TWO_SIDED|90.0|-35.18|-15.89|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.89|-35.18|<.0001
71690091|NCT01904032|142896500|SUPERIORITY||Mean Difference (Final Values)|-0.0424|STANDARD_ERROR_OF_MEAN|3.6619||0.9908|TWO_SIDED|95.0|-7.2946|7.2097|||t-test, 2 sided|||The null hypothesis is that there is no difference in the PAID change score between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||7.2097|-7.2946|.9908
71931047|NCT03985293|143383021|SUPERIORITY||Difference in LS Mean|-30.01|||<|0.0001|TWO_SIDED|90.0|-39.8|-20.21|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.21|-39.80|<.0001
71931048|NCT03985293|143383021|SUPERIORITY||Difference in LS Mean|-27.48|||<|0.0001|TWO_SIDED|90.0|-37.63|-17.33|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-17.33|-37.63|<.0001
71931049|NCT03985293|143383021|SUPERIORITY||Difference in LS Mean|-31.77|||<|0.0001|TWO_SIDED|90.0|-41.77|-21.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.78|-41.77|<.0001
71931050|NCT03985293|143383022|SUPERIORITY||Difference in LS Mean|-3.63||||0.5449|TWO_SIDED|90.0|-13.51|6.25|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||6.25|-13.51|0.5449
71931051|NCT03985293|143383022|SUPERIORITY||Difference in LS Mean|-17.12||||0.0031|TWO_SIDED|90.0|-26.62|-7.63|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-7.63|-26.62|0.0031
71931052|NCT03985293|143383022|SUPERIORITY||Difference in LS Mean|-20.64||||0.0005|TWO_SIDED|90.0|-30.31|-10.96|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-10.96|-30.31|0.0005
71931053|NCT03985293|143383022|SUPERIORITY||Difference in LS Mean|-24.12|||<|0.0001|TWO_SIDED|90.0|-34.2|-14.04|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.04|-34.20|<.0001
71931054|NCT03985293|143383022|SUPERIORITY||Difference in LS Mean|-25.21|||<|0.0001|TWO_SIDED|90.0|-35.44|-14.97|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.97|-35.44|<.0001
71931055|NCT03985293|143383023|SUPERIORITY||Difference in LS Mean|-7.7||||0.294|TWO_SIDED|90.0|-19.78|4.38|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||4.38|-19.78|0.2940
71931056|NCT03985293|143383023|SUPERIORITY||Difference in LS Mean|-23.77||||0.0008|TWO_SIDED|90.0|-35.37|-12.17|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-12.17|-35.37|0.0008
71690092|NCT01904032|142896501|SUPERIORITY||Mean Difference (Final Values)|0.4966|STANDARD_ERROR_OF_MEAN|3.1474||0.8749|TWO_SIDED|95.0|-5.7366|6.7298|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in systolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||6.7298|-5.7366|.8749
71690093|NCT01904032|142896502|SUPERIORITY||Mean Difference (Final Values)|1.5125|STANDARD_ERROR_OF_MEAN|1.8636||0.4187|TWO_SIDED|95.0|-2.1784|5.2033|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change in diastolic blood pressure between women who received high dose Vitamin D therapy versus low dose Vitamin D therapy.||5.2033|-2.1784|.4187
71690094|NCT01903993|142896549|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69|||=|0.0106|TWO_SIDED|95.0|0.52|0.92|||Log rank (Stratified)|||Hazard ratios (HR) were estimated by a Cox regression model.||0.92|0.52|= 0.0106
71690095|NCT01903993|142896550|SUPERIORITY_OR_OTHER_LEGACY||Difference in Response Rates|0.59|||=|0.8884|TWO_SIDED|95.0|-7.67|8.85|||Cochran-Mantel-Haenszel|||||8.85|-7.67|= 0.8884
71690096|NCT01903993|142896551|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.92|||=|0.5563|TWO_SIDED|95.0|0.71|1.2|||Log rank (Stratified)|||HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.||1.20|0.71|=0.5563
71690097|NCT01903993|142896552|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.32|||=|0.0028|TWO_SIDED|95.0|0.15|0.7|||Log rank (unstratified)|||HR were estimated by a unstratified Cox regression model.||0.70|0.15|= 0.0028
71690098|NCT01868165|142896569|OTHER||Slope|0.58|||||TWO_SIDED|95.0|-0.6|1.77|||||"Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).~Multiple adjustments including; age, sex, education."|||1.77|-0.60|
71931057|NCT03985293|143383023|SUPERIORITY||Difference in LS Mean|-33.23|||<|0.0001|TWO_SIDED|90.0|-45.05|-21.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-21.40|-45.05|<.0001
71690099|NCT01603407|142896587|SUPERIORITY|||||||0.3904|||||||Mixed Models Analysis|||||||0.3904
71931058|NCT03985293|143383023|SUPERIORITY||Difference in LS Mean|-31.66|||<|0.0001|TWO_SIDED|90.0|-44.14|-19.19|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-19.19|-44.14|<.0001
71931059|NCT03985293|143383023|SUPERIORITY||Difference in LS Mean|-33.59|||<|0.0001|TWO_SIDED|90.0|-46.67|-20.51|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.51|-46.67|<.0001
71931060|NCT03985293|143383024|SUPERIORITY||Difference in LS Mean|-14.12||||0.0464|TWO_SIDED|90.0|-25.77|-2.47|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.47|-25.77|0.0464
71931061|NCT03985293|143383024|SUPERIORITY||Difference in LS Mean|-25.84||||0.0002|TWO_SIDED|90.0|-37.05|-14.62|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-14.62|-37.05|0.0002
71931062|NCT03985293|143383024|SUPERIORITY||Difference in LS Mean|-31.78|||<|0.0001|TWO_SIDED|90.0|-43.2|-20.35|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.35|-43.20|<.0001
71931063|NCT03985293|143383024|SUPERIORITY||Difference in LS Mean|-27.02||||0.0002|TWO_SIDED|90.0|-39.03|-15.01|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-15.01|-39.03|0.0002
71931064|NCT03985293|143383024|SUPERIORITY||Difference in LS Mean|-33.24|||<|0.0001|TWO_SIDED|90.0|-45.63|-20.84|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-20.84|-45.63|<.0001
71690100|NCT01603407|142896587|SUPERIORITY|||||||0.569|||||||Mixed Models Analysis|||||||0.5690
71690101|NCT01603407|142896587|SUPERIORITY|||||||0.1518|||||||Mixed Models Analysis|||||||0.1518
71690102|NCT01603407|142896588|SUPERIORITY|||||||0.7365|||||||Mixed Models Analysis|||||||0.7365
71690103|NCT01603407|142896588|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71690104|NCT01603407|142896588|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71690105|NCT01603407|142896589|SUPERIORITY|||||||0.2456|||||||Mixed Models Analysis|||||||0.2456
71690106|NCT01603407|142896589|SUPERIORITY|||||||0.0369|||||||Mixed Models Analysis|||||||0.0369
71690107|NCT01603407|142896589|SUPERIORITY|||||||0.3589|||||||Mixed Models Analysis|||||||0.3589
71690108|NCT01603407|142896590|SUPERIORITY|||||||0.7335|||||||Mixed Models Analysis|||||||0.7335
71690109|NCT01603407|142896590|SUPERIORITY|||||||0.0004|||||||Mixed Models Analysis|||||||0.0004
71690110|NCT01603407|142896590|SUPERIORITY|||||||0.0001|||||||Mixed Models Analysis|||||||0.0001
71690111|NCT01603407|142896591|SUPERIORITY|||||||0.9532|||||||Mixed Models Analysis|||||||0.9532
71690112|NCT01603407|142896591|SUPERIORITY|||||||0.004|||||||Mixed Models Analysis|||||||0.0040
71690113|NCT01603407|142896591|SUPERIORITY|||||||0.0046|||||||Mixed Models Analysis|||||||0.0046
71690114|NCT01603407|142896592|SUPERIORITY|||||||0.332|||||||Mixed Models Analysis|||||||0.3320
71690115|NCT01603407|142896592|SUPERIORITY|||||||0.1248|||||||Mixed Models Analysis|||||||0.1248
71690116|NCT01603407|142896592|SUPERIORITY|||||||0.5854|||||||Mixed Models Analysis|||||||0.5854
71690117|NCT01603407|142896593|SUPERIORITY|||||||0.30814|||||||Mixed Models Analysis|||||||0.30814
71690118|NCT01603407|142896593|SUPERIORITY|||||||0.1405|||||||Mixed Models Analysis|||||||0.1405
71690119|NCT01603407|142896593|SUPERIORITY|||||||0.664|||||||Mixed Models Analysis|||||||0.6640
71690120|NCT01603407|142896595|SUPERIORITY|||||||0.8345|||||||Mixed Models Analysis|||||||0.8345
71690121|NCT01603407|142896595|SUPERIORITY|||||||0.3762|||||||Mixed Models Analysis|||||||0.3762
71690122|NCT01603407|142896595|SUPERIORITY|||||||0.5059|||||||Mixed Models Analysis|||||||0.5059
71690123|NCT01603407|142896596|SUPERIORITY|||||||0.5947|||||||Mixed Models Analysis|||||||0.5947
71690124|NCT01603407|142896596|SUPERIORITY|||||||0.1098|||||||Mixed Models Analysis|||||||0.1098
71690125|NCT01603407|142896596|SUPERIORITY|||||||0.2803|||||||Mixed Models Analysis|||||||0.2803
71690126|NCT01603407|142896597|SUPERIORITY|||||||0.3875|||||||Mixed Models Analysis|||||||0.3875
71690127|NCT01603407|142896597|SUPERIORITY|||||||0.424|||||||Mixed Models Analysis|||||||0.4240
71690128|NCT01603407|142896597|SUPERIORITY|||||||0.9683|||||||Mixed Models Analysis|||||||0.9683
71690129|NCT01603407|142896598|SUPERIORITY|||||||0.6161|||||||Mixed Models Analysis|||||||0.6161
71690130|NCT01603407|142896598|SUPERIORITY|||||||0.7302|||||||Mixed Models Analysis|||||||0.7302
71690131|NCT01603407|142896598|SUPERIORITY|||||||0.9007|||||||Mixed Models Analysis|||||||0.9007
71690132|NCT01603407|142896599|SUPERIORITY|||||||0.8138|||||||Mixed Models Analysis|||||||0.8138
71690133|NCT01603407|142896599|SUPERIORITY|||||||0.5995|||||||Mixed Models Analysis|||||||0.5995
71690134|NCT01603407|142896599|SUPERIORITY|||||||0.7616|||||||Mixed Models Analysis|||||||0.7616
71690135|NCT01603407|142896600|SUPERIORITY|||||||0.68|||||||Mixed Models Analysis|||||||0.6800
71690136|NCT01603407|142896600|SUPERIORITY|||||||0.4365|||||||Mixed Models Analysis|||||||0.4365
71690137|NCT01603407|142896600|SUPERIORITY|||||||0.7281|||||||Mixed Models Analysis|||||||0.7281
71690138|NCT01603407|142896601|SUPERIORITY||Mean Difference (Net)|-1.545||||0.0041|TWO_SIDED|98.3|-2.6611|-0.2479|||Mixed Models Analysis|||||-0.2479|-2.6611|0.0041
71690139|NCT01603407|142896601|SUPERIORITY||Mean Difference (Net)|0.9076||||0.9076|TWO_SIDED|98.3|-1.248|1.1331|||Mixed Models Analysis|||||1.1331|-1.248|0.9076
71690140|NCT01603407|142896601|SUPERIORITY||Mean Difference (Net)|1.3971||||0.0054|TWO_SIDED|98.3|0.2014|2.5927|||Mixed Models Analysis|||||2.5927|0.2014|0.0054
71690141|NCT01603407|142896602|SUPERIORITY||Mean Difference (Net)|-1.48|||<|0.0001|TWO_SIDED|98.3|-2.3242|-0.6358|||Mixed Models Analysis|||||-0.6358|-2.3242|<0.0001
71690142|NCT01603407|142896602|SUPERIORITY||Mean Difference (Net)|3.054|||<|0.0001|TWO_SIDED|98.3|2.2222|3.8857|||Mixed Models Analysis|||||3.8857|2.2222|<0.0001
71690143|NCT01603407|142896602|SUPERIORITY||Mean Difference (Net)|4.534|||<|0.0001|TWO_SIDED|98.3|3.6941|5.3738|||Mixed Models Analysis|||||5.3738|3.6941|<0.0001
71931065|NCT03985293|143383025|SUPERIORITY||Difference in LS Mean|0.06||||0.8011|TWO_SIDED|90.0|-0.33|0.44|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.44|-0.33|0.8011
71931066|NCT03985293|143383025|SUPERIORITY||Difference in LS Mean|0.02||||0.9149|TWO_SIDED|90.0|-0.35|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.35|0.9149
71690144|NCT01603407|142896603|SUPERIORITY||Mean Difference (Net)|-0.6205||||0.0853|TWO_SIDED|98.3|-1.4845|0.2434|||Mixed Models Analysis|||||0.2434|-1.4845|0.0853
71690145|NCT01603407|142896603|SUPERIORITY||Mean Difference (Net)|-0.876||||0.0143|TWO_SIDED|98.3|-1.7292|-0.0229|||Mixed Models Analysis|||||-0.0229|-1.7292|0.0143
71690146|NCT01603407|142896603|SUPERIORITY||Mean Difference (Net)|-0.2555||||0.4731|TWO_SIDED|98.3|-1.1117|0.6007|||Mixed Models Analysis|||||0.6007|-1.1117|0.4731
71690147|NCT02500719|142896604|SUPERIORITY||Mean Difference (Net)|0.1319||||0.029|ONE_SIDED||||||t-test, 1 sided|||This test is to determine if the difference between engagement and disengagement of emotional arousal is increased by real-time neurofeedback guidance in PTSD participants.||||.029
71690148|NCT01990768|142896605|SUPERIORITY||Odds Ratio (OR)|0.87||||0.1809|ONE_SIDED|||||Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.|Regression, Logistic|Analysis was adjusted for regional site. Missing outcomes were multiply imputed.|Odds ratio for unfavorable GOS-E (\<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)|This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.||||.1809
71690149|NCT03538691|142896624|SUPERIORITY||Hazard Ratio (HR)|1.138||||0.51|TWO_SIDED|95.0|0.776|1.669|||Log Rank||The hazard ratio and 95% confidence interval (CI) were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.669|0.776|0.5100
71690150|NCT03538691|142896625|SUPERIORITY||Least Squares (LS) Mean Difference|0.23||||0.2393|TWO_SIDED|95.0|-0.16|0.62||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||||0.62|-0.16|0.2393
71690151|NCT03538691|142896626|SUPERIORITY||Hazard Ratio (HR)|1.177||||0.3086|TWO_SIDED|95.0|0.857|1.615|||Log Rank||The hazard ratio and 95% CI were derived from the Cox proportional hazard model with treatment as fixed effect.|||1.615|0.857|0.3086
71690152|NCT03538691|142896627|SUPERIORITY|||||||0.603|||||||Chi-squared|||||||0.6030
71690153|NCT03538691|142896628|SUPERIORITY|||||||0.7081|||||||Chi-squared|||Week 21||||0.7081
71690154|NCT03538691|142896628|SUPERIORITY|||||||0.4589|||||||Chi-squared|||Week 23||||0.4589
71690155|NCT03538691|142896628|SUPERIORITY|||||||0.5314|||||||Chi-squared|||Week 25||||0.5314
71690156|NCT03538691|142896628|SUPERIORITY|||||||0.1433|||||||Chi-squared|||Week 29||||0.1433
71690157|NCT03538691|142896628|SUPERIORITY|||||||0.9636|||||||Chi-squared|||Week 33||||0.9636
71690158|NCT03538691|142896628|SUPERIORITY|||||||0.7596|||||||Chi-squared|||Week 37||||0.7596
71690159|NCT03538691|142896628|SUPERIORITY|||||||0.2402|||||||Chi-squared|||Week 41||||0.2402
71690160|NCT03538691|142896628|SUPERIORITY|||||||0.8363|||||||Chi-squared|||Week 45||||0.8363
71690161|NCT03538691|142896628|SUPERIORITY|||||||0.8308|||||||Chi-squared|||Week 46||||0.8308
71690162|NCT03538691|142896629|SUPERIORITY||LS Mean Difference|-0.12||||0.8806|TWO_SIDED|95.0|-1.73|1.49|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||1.49|-1.73|0.8806
71690163|NCT03538691|142896630|SUPERIORITY||LS Mean Difference|0.03||||0.7956|TWO_SIDED|95.0|-0.18|0.24|||ANCOVA|P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.||||0.24|-0.18|0.7956
71690164|NCT03538691|142896631|SUPERIORITY||LS Mean Difference|0.15||||0.5223|TWO_SIDED|95.0|-0.31|0.61||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Work/School||0.61|-0.31|0.5223
71690165|NCT03538691|142896631|SUPERIORITY||LS Mean Difference|0.36||||0.0904|TWO_SIDED|95.0|-0.06|0.77||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Social Life||0.77|-0.06|0.0904
71931067|NCT03985293|143383025|SUPERIORITY||Difference in LS Mean|-0.08||||0.7216|TWO_SIDED|90.0|-0.46|0.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.30|-0.46|0.7216
71931068|NCT03985293|143383025|SUPERIORITY||Difference in LS Mean|-0.42||||0.0758|TWO_SIDED|90.0|-0.8|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-0.80|0.0758
71931069|NCT03985293|143383025|SUPERIORITY||Difference in LS Mean|-0.4||||0.086|TWO_SIDED|90.0|-0.77|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-0.77|0.0860
71931070|NCT03985293|143383026|SUPERIORITY||Difference in LS Mean|-0.08||||0.7898|TWO_SIDED|90.0|-0.59|0.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.42|-0.59|0.7898
71931071|NCT03985293|143383026|SUPERIORITY||Difference in LS Mean|0.16||||0.5829|TWO_SIDED|90.0|-0.33|0.66|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.66|-0.33|0.5829
71931072|NCT03985293|143383026|SUPERIORITY||Difference in LS Mean|-0.52||||0.0827|TWO_SIDED|90.0|-1.02|-0.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.03|-1.02|0.0827
71931073|NCT03985293|143383026|SUPERIORITY||Difference in LS Mean|-0.8||||0.0101|TWO_SIDED|90.0|-1.31|-0.29|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.29|-1.31|0.0101
71931074|NCT03985293|143383026|SUPERIORITY||Difference in LS Mean|-1.09||||0.0004|TWO_SIDED|90.0|-1.59|-0.59|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.59|-1.59|0.0004
71931075|NCT03985293|143383027|SUPERIORITY||Difference in LS Mean|-0.1||||0.7985|TWO_SIDED|90.0|-0.75|0.55|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.55|-0.75|0.7985
71931076|NCT03985293|143383027|SUPERIORITY||Difference in LS Mean|-0.23||||0.5484|TWO_SIDED|90.0|-0.86|0.4|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.40|-0.86|0.5484
71931077|NCT03985293|143383027|SUPERIORITY||Difference in LS Mean|-0.75||||0.0541|TWO_SIDED|90.0|-1.38|-0.11|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.11|-1.38|0.0541
71931078|NCT03985293|143383027|SUPERIORITY||Difference in LS Mean|-1.6|||<|0.0001|TWO_SIDED|90.0|-2.26|-0.95|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.95|-2.26|<.0001
71931079|NCT03985293|143383027|SUPERIORITY||Difference in LS Mean|-2.25|||<|0.0001|TWO_SIDED|90.0|-2.9|-1.6|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.60|-2.90|<.0001
71931080|NCT03985293|143383028|SUPERIORITY||Difference in LS Mean|0.31||||0.4692|TWO_SIDED|90.0|-0.4|1.03|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.03|-0.40|0.4692
71931081|NCT03985293|143383028|SUPERIORITY||Difference in LS Mean|0.09||||0.8274|TWO_SIDED|90.0|-0.6|0.78|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.78|-0.60|0.8274
71931082|NCT03985293|143383028|SUPERIORITY||Difference in LS Mean|-0.72||||0.0887|TWO_SIDED|90.0|-1.42|-0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.02|-1.42|0.0887
71931083|NCT03985293|143383028|SUPERIORITY||Difference in LS Mean|-1.61||||0.0003|TWO_SIDED|90.0|-2.33|-0.88|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-0.88|-2.33|0.0003
71931084|NCT03985293|143383028|SUPERIORITY||Difference in LS Mean|-2.95|||<|0.0001|TWO_SIDED|90.0|-3.67|-2.22|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.22|-3.67|<.0001
71931085|NCT03985293|143383029|SUPERIORITY||Difference in LS Mean|0.15||||0.7758|TWO_SIDED|90.0|-0.7|0.99|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.99|-0.70|0.7758
71931086|NCT03985293|143383029|SUPERIORITY||Difference in LS Mean|0.23||||0.6367|TWO_SIDED|90.0|-0.58|1.05|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.05|-0.58|0.6367
71931087|NCT03985293|143383029|SUPERIORITY||Difference in LS Mean|-0.81||||0.1082|TWO_SIDED|90.0|-1.63|0.02|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.02|-1.63|0.1082
71931088|NCT03985293|143383029|SUPERIORITY||Difference in LS Mean|-2.28|||<|0.0001|TWO_SIDED|90.0|-3.14|-1.42|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.42|-3.14|<.0001
71931089|NCT03985293|143383029|SUPERIORITY||Difference in LS Mean|-3.57|||<|0.0001|TWO_SIDED|90.0|-4.44|-2.7|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-2.70|-4.44|<.0001
71931090|NCT03985293|143383030|SUPERIORITY||Difference in LS Mean|0.45||||0.4325|TWO_SIDED|90.0|-0.5|1.41|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.41|-0.50|0.4325
71931091|NCT03985293|143383030|SUPERIORITY||Difference in LS Mean|0.38||||0.4978|TWO_SIDED|90.0|-0.54|1.3|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||1.30|-0.54|0.4978
71931092|NCT03985293|143383030|SUPERIORITY||Difference in LS Mean|-0.73||||0.197|TWO_SIDED|90.0|-1.66|0.2|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||0.20|-1.66|0.1970
71931093|NCT03985293|143383030|SUPERIORITY||Difference in LS Mean|-2.04||||0.0006|TWO_SIDED|90.0|-3.01|-1.07|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-1.07|-3.01|0.0006
71931094|NCT03985293|143383030|SUPERIORITY||Difference in LS Mean|-4.17|||<|0.0001|TWO_SIDED|90.0|-5.15|-3.18|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)|PF-06882961 = Test Placebo = Reference|||-3.18|-5.15|<.0001
71931095|NCT00858234|143383150|OTHER|Accumulation Ratio (Day 11 AUC0-24hr/Day 1 AUC0-24hr)|Accumulation ratio|1.08|||||TWO_SIDED|90.0|0.8|1.45|||||Back-transformed least squares mean difference and 90% confidence interval from mixed effects model performed on natural log-transformed values.|||1.45|0.80|
71931096|NCT00529802|143383233|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.69|TWO_SIDED|95.0|-9.3|13.23|||t-test, 2 sided|Relative changes in tumor size were log-transformed to satisfy the normality assumption for the t-test.|Mean difference is the difference between Low and High SUV uptake groups in tumor size percent (%) change from baseline, and is reported on the raw scale. Tumor size changes were log-transformed for the t-test.|Relative changes in tumor size were log-transformed to satisfy the normality assumption.||13.23|-9.3|0.69
71690166|NCT03538691|142896631|SUPERIORITY||LS Mean Difference|0.25||||0.2289|TWO_SIDED|95.0|-0.16|0.67||P-value was derived from an ANCOVA model with treatment, pooled center as factor and Baseline value as covariance.|ANCOVA|||SDS Individual Item: Family Life||0.67|-0.16|0.2289
71690167|NCT03479944|142896647|SUPERIORITY||Least Squares Mean Difference|-1.505|||<|0.0001|TWO_SIDED|95.0|-1.72|-1.289|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-1.289|-1.720|<0.0001
71690168|NCT03479944|142896648|SUPERIORITY||Least Squares Mean Difference|1.2||||0.2602|TWO_SIDED|95.0|-0.9|3.3|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures|||3.3|-0.9|0.2602
71690169|NCT03479944|142896649|SUPERIORITY||Least Squares Mean Difference|-11.52|||||TWO_SIDED|95.0|-15.87|-7.18|||||Least Squares Mean Difference from a Mixed Model for Repeated Measures|||-7.18|-15.87|
71690170|NCT02029274|142896650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.551|STANDARD_ERROR_OF_MEAN|11.5519||0.9621|TWO_SIDED|95.0|-22.447|23.549|||Repeated measures analysis|||||23.549|-22.447|0.9621
71690171|NCT02029274|142896650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-15.368|STANDARD_ERROR_OF_MEAN|10.9297||0.1637|TWO_SIDED|95.0|-37.128|6.391|||Repeated measures analysis|||||6.391|-37.128|0.1637
71690172|NCT02029274|142896650|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-13.709|STANDARD_ERROR_OF_MEAN|11.6016||0.2409|TWO_SIDED|95.0|-36.806|9.388|||Repeated measures|||||9.388|-36.806|0.2409
71690173|NCT03654729|142896661|SUPERIORITY||Risk Ratio (RR)|1.3842||||0.2266|TWO_SIDED|95.0|0.8172|2.3446|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||2.3446|0.8172|0.2266
71931097|NCT00529802|143383234|SUPERIORITY_OR_OTHER||Slope|0.0028|STANDARD_ERROR_OF_MEAN|0.00109||0.013|TWO_SIDED|95.0|0.00063|0.004997|||Regression, Linear|Tumor size change (outcome variable) was log-transformed to satisfy the normality assumption.|Outcome was log(tumor size at 8 weeks/tumor size at baseline), and the predictor was the early change in aveSUVmax \[(aveSUVmax at 2 weeks - aveSUVmax at baseline)/aveSUVmax at baseline\] x 100%.|The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.||0.004997|0.00063|0.013
71931098|NCT01336608|143383235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.01||||0.969|TWO_SIDED|95.0|-0.71|0.74|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.74|-0.71|0.969
71931099|NCT01336608|143383235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.22||||0.568|TWO_SIDED|95.0|-0.53|0.96|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.96|-0.53|0.568
71931100|NCT01336608|143383235|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.2||||0.566|TWO_SIDED|95.0|-0.49|0.89|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)||||0.89|-0.49|0.566
71931101|NCT01336608|143383236|SUPERIORITY_OR_OTHER||Least squares mean difference|0.082||||0.007|TWO_SIDED|95.0|0.023|0.141||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.141|0.023|0.007
71690174|NCT03654729|142896661|SUPERIORITY||Risk Ratio (RR)|1.0951||||0.7434|TWO_SIDED|95.0|0.6356|1.887|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel estimate of the common relative risk of moderate to severe CIPN.||1.8870|0.6356|0.7434
71690175|NCT01919164|142896695|SUPERIORITY||Mean Difference (Final Values)|0.01|||||TWO_SIDED|95.0|-0.01|0.03||||||Descriptive statistics was provided for primary endpoint.||0.03|-0.01|
71690176|NCT01919164|142896695|SUPERIORITY||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.01|0.04||||||Descriptive statistics was provided for primary endpoint.||0.04|-0.01|
71690177|NCT01919164|142896695|SUPERIORITY||Mean Difference (Final Values)|0.04|||||TWO_SIDED|95.0|0.02|0.06||||||Descriptive statistics was provided for primary endpoint.||0.06|0.02|
71690178|NCT01919164|142896695|SUPERIORITY||Mean Difference (Final Values)|0.05|||||TWO_SIDED|95.0|0.03|0.07||||||Descriptive statistics was provided for primary endpoint.||0.07|0.03|
71690179|NCT01431313|142896724|OTHER|Mixed effects model across all time points.||||||0.002|||||||Mixed Models Analysis|||||||0.002
71690180|NCT01431313|142896724|OTHER|Mixed effects model across all time points.||||||0.003|||||||Mixed Models Analysis|||||||0.003
71690181|NCT01431313|142896724|OTHER|Mixed effects model across all time points.||||||0.66|||||||Mixed Models Analysis|||||||0.66
71690182|NCT01431313|142896726|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71690183|NCT01431313|142896726|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71690184|NCT01431313|142896726|OTHER|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71690185|NCT01431313|142896727|OTHER|Mixed effects model across all time points.||||||0.8|||||||Mixed Models Analysis|||||||0.8
71690186|NCT01431313|142896727|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
71690187|NCT01431313|142896727|OTHER|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis|||||||0.01
71690188|NCT01431313|142896728|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71690189|NCT01431313|142896728|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71690190|NCT01431313|142896728|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||||||0.17
71690191|NCT01431313|142896729|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71690192|NCT01431313|142896729|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71690193|NCT01431313|142896729|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71690194|NCT01431313|142896730|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71690195|NCT01431313|142896730|OTHER|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71690196|NCT01431313|142896731|OTHER|Mixed effects model across all doses.|||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71931102|NCT01336608|143383236|SUPERIORITY_OR_OTHER||Least squares mean difference|0.155|||<|0.001|TWO_SIDED|95.0|0.095|0.215||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.215|0.095|<0.001
71931103|NCT01336608|143383236|SUPERIORITY_OR_OTHER||Least squares mean difference|0.074||||0.012|TWO_SIDED|95.0|0.016|0.131||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).||||0.131|0.016|0.012
71931104|NCT01336608|143383237|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.22||Nominal p-value|ANCOVA|||||-0.22|-0.72|<0.001
71931105|NCT01336608|143383237|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.5|||<|0.001|TWO_SIDED|95.0|-0.76|-0.24||Nominal p-value|ANCOVA|||||-0.24|-0.76|<0.001
71931106|NCT01336608|143383237|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.03||||0.803|TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||||0.22|-0.29|0.803
71931107|NCT00080288|143383238|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.7|||<|0.0001||95.0|1.67|3.69|||ANCOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||3.69|1.67|<0.0001
71931108|NCT00080288|143383239|SUPERIORITY_OR_OTHER|||||||0.001|||||||Cochran-Mantel-Haenszel|The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.||||0.0010
71931109|NCT01143272|143383288|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.94|TWO_SIDED|95.0|0.55|1.9|||Regression, Cox|||||1.90|0.55|0.94
71931110|NCT01143272|143383288|SUPERIORITY_OR_OTHER|||||||0.25|||||||Fisher Exact|||||||0.25
71931111|NCT01143272|143383288|SUPERIORITY_OR_OTHER|||||||0.87|||||||Log Rank|||||||0.87
71931112|NCT01143272|143383290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.8|TWO_SIDED|95.0|0.49|1.73|||Regression, Cox|||||1.73|0.49|0.80
71931113|NCT01143272|143383290|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.93|TWO_SIDED|95.0|0.53|2.03||adjusting for age, sex, CRP, leukocyte count, duration of antibiotic treatment, and administration of antibiotics|Regression, Cox|||||2.03|0.53|0.93
71931114|NCT01143272|143383291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.6|TWO_SIDED|95.0|0.96|1.08||Association between initial leukocyte count and incidence of AAD|Regression, Logistic|||||1.08|0.96|0.6
71931115|NCT01143272|143383291|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.653|TWO_SIDED|95.0|1.0|1.01||Association between the initial C-reactive protein and incidence of AAD|Regression, Logistic|||||1.01|1.00|0.653
71931116|NCT00545181|143383308|SUPERIORITY_OR_OTHER|||||||0.75||95.0|||||Chi-squared, Corrected|||||||0.75
71931117|NCT00149669|143383320|SUPERIORITY||Odds Ratio (OR)|8.67|||<|0.01|TWO_SIDED|95.0|4.24|17.73|||General Estimating Equation (GEE)|||||17.73|4.24|<0.01
71931118|NCT00149669|143383321|SUPERIORITY||Odds Ratio (OR)|0.91||||0.82|TWO_SIDED|95.0|0.43|1.95|||General Estimating Equation (GEE)|||||1.95|.43|0.82
71931119|NCT00149669|143383322|SUPERIORITY||Odds Ratio (OR)|0.61|||=|0.19|TWO_SIDED|95.0|0.29|1.26|||General Estimating Equation (GEE)|||||1.26|0.29|=0.19
71931120|NCT02458365|143383327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||<|0.0001|TWO_SIDED|95.0|0.51|0.75|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.75|.51|<.0001
71931121|NCT02458365|143383327|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.45|0.68|||Regression, Linear|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.68|.45|<.0001
71931122|NCT02458365|143383328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||<|0.001|TWO_SIDED|95.0|0.57|0.84|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.84|.57|<.001
71931123|NCT02458365|143383328|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61|||<|0.0001|TWO_SIDED|95.0|0.5|0.75|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.75|.50|<.0001
71931124|NCT02458365|143383329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.0001|TWO_SIDED|95.0|0.43|0.67|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.67|.43|<.0001
71690197|NCT01431313|142896731|OTHER|Mixed effects model across all doses.||||||0.21|||||||Mixed Models Analysis|||||||0.21
71931125|NCT02458365|143383329|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.45|||<|0.0001|TWO_SIDED|95.0|0.36|0.56|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.56|.36|<.0001
71931126|NCT02458365|143383330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5|||<|0.0001|TWO_SIDED|95.0|0.41|0.62|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.62|.41|<.0001
71931127|NCT02458365|143383330|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||<|0.0001|TWO_SIDED|95.0|0.35|0.54|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.54|.35|<.0001
71931128|NCT02458365|143383331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.001|TWO_SIDED|95.0|0.38|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.38|.001
71931129|NCT02458365|143383331|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.013|TWO_SIDED|95.0|0.4|0.9|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.90|.40|.013
71931130|NCT02458365|143383332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53|||<|0.001|TWO_SIDED|95.0|0.37|0.76|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.76|.37|<.001
71931131|NCT02458365|143383332|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.35|0.82|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.82|.35|.004
71931132|NCT02458365|143383333|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.002|TWO_SIDED|95.0|0.35|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.78|.35|.002
71931133|NCT02458365|143383333|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.5||||0.005|TWO_SIDED|95.0|0.31|0.81|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.81|.31|.005
71931134|NCT02458365|143383334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43|||<|0.0001|TWO_SIDED|95.0|0.29|0.64|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design||||.64|.29|<.0001
71931135|NCT02458365|143383334|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.003|TWO_SIDED|95.0|0.29|0.77|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.||||.77|.29|.003
71931136|NCT04840901|143383407|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.16|||ANCOVA|||||1.16|1.03|
71931137|NCT04840901|143383408|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.07|||||TWO_SIDED|90.0|1.02|1.14|||ANCOVA|||||1.14|1.02|
71931138|NCT04840901|143383409|EQUIVALENCE|PK parameters were powered to test equivalence with a power of 90% that the 90% confidence interval (CI) of the geometric mean ratio fall within 0.8 to 1.25 equivalence margin.|Ratio of Geometric LS Mean|1.09|||||TWO_SIDED|90.0|1.03|1.14|||ANCOVA|||||1.14|1.03|
71931139|NCT05354206|143383411|SUPERIORITY||Mean Difference (Final Values)|0.405|STANDARD_DEVIATION|0.285|<|0.05|TWO_SIDED|||||p-values have not been adjusted for multiple comparisons|t-test, 2 sided||Difference of RST from 1 for hip range of motion task without stimulation.|"Reticulospinal tract (RST) contribution computed as RST = (visual - startle)/(visual - auditory) reaction times, where a RST value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task.~A one sample t-test (or Wilcoxon signed-rank test for non-normally distributed data) was used to test the hypothesis that the RST contribution for a given movement was significantly greater than 1."||||<0.05
71931140|NCT04936334|143383416|SUPERIORITY||McNemar|0.03|||<|0.05|TWO_SIDED||||||McNemar|||||||<0.05
71931141|NCT02209272|143383419|SUPERIORITY|||||||0.82|||||||t-test, 2 sided|||||||0.82
71931142|NCT02209272|143383420|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
71931143|NCT02209272|143383421|SUPERIORITY|||||||0.57|||||||t-test, 2 sided|||||||0.57
71931144|NCT00110084|143383429|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|50.0|||||TWO_SIDED|95.0|36.0|64.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||64|36|
71690198|NCT01431313|142896731|OTHER|Mixed effects model across all doses.||||||0.59|||||||Mixed Models Analysis|||||||0.59
71931145|NCT00663039|143383443|SUPERIORITY|||||||0.758|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect Scores between Oxytocin and Placebo Arms||||0.758
71931146|NCT00663039|143383443|SUPERIORITY|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill scores between Oxytocin and Placebo arms||||0.779
71931147|NCT00663039|143383444|SUPERIORITY|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 1 scores between Oxytocin and Placebo Arms||||0.578
71931148|NCT00663039|143383444|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 2 scores between Oxytocin and Placebo Arms||||0.28
71931149|NCT00663039|143383444|SUPERIORITY|||||||0.707|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 3 scores between Oxytocin and Placebo Arms||||0.707
71931150|NCT00663039|143383445|SUPERIORITY|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total amount of money offered during the trust game between the Oxytocin and Placebo arms||||0.391
71931151|NCT00663039|143383446|SUPERIORITY|||||||0.559|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.559
71931152|NCT00663039|143383446|SUPERIORITY|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Oxytocin and Placebo arms.||||0.858
71931153|NCT00663039|143383446|SUPERIORITY|||||||0.514|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.514
71931154|NCT00663039|143383446|SUPERIORITY|||||||0.088|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Oxytocin and Placebo arms||||0.088
71931155|NCT00663039|143383447|SUPERIORITY|||||||0.296|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Oxytocin and Placebo arms.||||0.296
71931156|NCT00663039|143383447|SUPERIORITY|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.136
71690199|NCT01563198|142896747|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)||||<0.0001
71690200|NCT01563198|142896748|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71690201|NCT01563198|142896749|SUPERIORITY||||||<|0.0001|||||||Chi-squared|||||||<0.0001
71931157|NCT00663039|143383447|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Oxytocin and Placebo arms.||||0.47
71931158|NCT00663039|143383447|SUPERIORITY|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.||||0.702
71931159|NCT00663039|143383448|SUPERIORITY|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||Comparison of Brief Assessments of Cognition for Schizophrenia scores between the Oxytocin and Placebo arms.||||0.451
71931160|NCT00663039|143383449|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.9
71931161|NCT00663039|143383450|SUPERIORITY|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||Comparison of Reading the Mind in the Eyes total scores between Oxytocin and Placebo arms||||0.946
71931162|NCT00663039|143383451|SUPERIORITY|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Total scores between Oxytocin and Placebo arms||||0.016
71931163|NCT00663039|143383451|SUPERIORITY|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Hits between Oxytocin and Placebo arms||||0.185
71931164|NCT00663039|143383451|SUPERIORITY|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition False Alarms between Oxytocin and Placebo arms||||0.404
71931165|NCT05016765|143383468|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|paired t-test||||||<0.001
71931166|NCT05016765|143383468|OTHER|Pearson correlation test|Pearson's R|0.21||||0.33|TWO_SIDED|95.0|-0.22|0.56|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic frequency with stimulation during this study) with the change in tic frequency (measured as the number of 10-second tic-free intervals) during active, rhythmic stimulation in the randomized, controlled trial of MNS that all participants had previously completed.||0.56|-0.22|0.33
71931167|NCT05016765|143383469|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Paired Samples Wilcoxon Test||||||<0.001
71931168|NCT05016765|143383469|OTHER|Pearson's R|Pearson's R|0.36||||0.08|TWO_SIDED|95.0|-0.05|0.66|||Regression, Linear|Pearson's R||Correlation of this Outcome measure (change in tic intensity during this study) with change in tic intensity during active, rhythmic stimulation during the randomized, controlled trial that all participants had previously completed.||0.66|-0.05|0.08
71931169|NCT05016765|143383474|OTHER|Traditional comparative||||||0.84|||||||Paired Sample t-Test, 2-Sided|||||||0.84
71931170|NCT04101721|143383485|NON_INFERIORITY|Non-inferiority margin is 5%|Adjusted difference|1.81|||||TWO_SIDED|95.1|-15.71|19.33||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||19.33|-15.71|
71931171|NCT04101721|143383486|SUPERIORITY||Adjusted difference|-3.66|||||TWO_SIDED|95.1|-19.86|12.54||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status.||12.54|-19.86|
71931172|NCT04101721|143383487|SUPERIORITY||Adjusted difference|10.1|||||TWO_SIDED|95.1|-9.83|30.02||||||Difference with confidence interval (CI) is calculated using Mantel-Haenszel weighting scheme adjusted by baseline ROP status||30.02|-9.83|
71931173|NCT00535301|143383551|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.24|STANDARD_DEVIATION|2.0||0.005|TWO_SIDED|95.0|0.1|0.6|||Chi-squared|||Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.||0.6|0.1|0.005
71931174|NCT00535301|143383552|SUPERIORITY_OR_OTHER|||||||0.5||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.5
71931175|NCT00535301|143383553|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71931176|NCT05144477|143383569|OTHER|Proportion of referrals who provided consent and enrolled into the study was calculated.|Proportion|0.64|||||TWO_SIDED|95.0|0.425|0.82||||||||0.820|0.425|
71931177|NCT05144477|143383570|OTHER|Proportion of enrolled participants who remained in the study at 30 days after the end of hospital care was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
71931178|NCT05144477|143383571|OTHER|Proportion of participants randomized to the FAID Fear Diary Intervention who wrote in the diary at least twice per week up until the end of hospital care was calculated.|Proportion|0.636|||||TWO_SIDED|95.0|0.308|0.891||||||||0.891|0.308|
71931179|NCT05144477|143383572|OTHER|Proportion of enrolled participants who provided complete data for at least 90% of all study assessments was calculated.|Proportion|0.875|||||TWO_SIDED|95.0|0.617|0.985||||||||0.985|0.617|
71931180|NCT05144477|143383573|OTHER|Proportion of intervention participants who agreed that the ICU diary was acceptable for reducing fear about their loved one's heart was calculated.|Proportion|0.8|||||TWO_SIDED|95.0|0.444|0.975||||||||0.975|0.444|
71931181|NCT05144477|143383574|OTHER|Proportion of intervention participants who agreed that the ICU diary was feasible for reducing fear about their loved one's heart was calculated.|Proportion|0.9|||||TWO_SIDED|95.0|0.555|0.998||||||||0.998|0.555|
71931182|NCT05144477|143383575|OTHER|Proportion of intervention participants who agreed that the ICU diary was appropriate for reducing fear about their loved one's heart was calculated.|Proportion|0.7|||||TWO_SIDED|95.0|0.348|0.933||||||||0.933|0.348|
71931183|NCT05144477|143383576|SUPERIORITY||Mean Difference (Final Values)|0.24||||0.63|TWO_SIDED|95.0|-0.83|1.32|||t-test, 2 sided|||Outcome analysis at the end of hospital care.||1.32|-0.83|.63
71931184|NCT05144477|143383576|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.86|TWO_SIDED|95.0|-0.92|1.08|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.08|-0.92|.86
71931185|NCT05144477|143383577|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.86|TWO_SIDED|95.0|-1.43|1.21|||t-test, 2 sided|||Outcome analysis for the end of hospital care.||1.21|-1.43|.86
71931186|NCT05144477|143383577|SUPERIORITY||Mean Difference (Final Values)|0.19||||0.75|TWO_SIDED|95.0|-1.1|1.58|||t-test, 2 sided|||Outcome analysis for 30 days after the end of hospital care.||1.58|-1.10|.75
71931187|NCT05144477|143383578|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.22|TWO_SIDED|95.0|-23.26|5.86|||t-test, 2 sided|||||5.86|-23.26|.22
71931188|NCT05144477|143383578|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||χ2(1) = 1.29|||.26
71931189|NCT05144477|143383578|SUPERIORITY|||||||1|||||||Fisher Exact|||A Fisher's Exact Test was conducted to compare the number of participants with a positive screen for PTSD symptoms (score \>=33) to those who did not have a positive screen for PTSD symptoms (score \< 33).||||1.00
71931190|NCT03111407|143383582|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.2342|||||||t-test, 2 sided|||"Hip Knee Angle value 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 179.9 +/-2.9 (44) (171, 185.3)~Conventional group: 178.9 +/-3.9 (26) (167, 185)"||||0.2342
71690202|NCT00524771|142896752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.5|1.5|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.||1.5|0.5|
71690203|NCT00524771|142896752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.4|1.7|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.||1.7|0.4|
71690204|NCT00524771|142896752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.2|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of less than 6 months.||2.2|0.3|
71690205|NCT00524771|142896752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.6|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.||2.6|0.3|
71690206|NCT00524771|142896752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.3|2.3|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of \> 12 months.||2.3|0.3|
71690207|NCT00524771|142896753|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.3|||||The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.|||2.3|0.2|
71690208|NCT00524771|142896753|NON_INFERIORITY_OR_EQUIVALENCE|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.2|2.6|||||Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.|||2.6|0.2|
71690209|NCT04819438|142896797|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of Cmax geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|117.05|||<|0.0001|TWO_SIDED|90.0|110.43|124.06|||ANOVA|||||124.06|110.43|<0.0001
71931191|NCT03111407|143383583|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4427|||||||t-test, 2 sided|||"Knee Society Score Assessment 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper)~iAssist group: 74.7 +/- 12.5 \[44\] (30.2, 78.0, 89.5), 95% C.I. (70.9, 78.5)~Conventional group: 72.4 +/- 11.6 \[26\] (45.0, 75.2, 90.1), 95% C.I. (67.7, 77.1)"||||0.4427
71690210|NCT04819438|142896798|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-t geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.82|||<|0.0001|TWO_SIDED|90.0|108.25|115.5|||ANOVA|||||115.50|108.25|<0.0001
71690211|NCT04819438|142896800|EQUIVALENCE|Acceptance criterion for bioequivalence analysis was that the 90% confidence interval for the Test/Reference ratio of AUC0-∞ geometric means was within the 80.00-125.00 range.|Geometric Mean Ratio|111.83|||<|0.0001|TWO_SIDED|90.0|108.19|115.29|||ANOVA|||||115.29|108.19|<0.0001
71690212|NCT03060291|142896833|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.549|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.549
71690213|NCT03060291|142896833|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.854|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.854
71690214|NCT03060291|142896833|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.469|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.469
71690215|NCT03060291|142896834|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.535|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.535
71690216|NCT03060291|142896834|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.081|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.081
71690217|NCT03060291|142896834|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.295|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.295
71690218|NCT03060291|142896835|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.149|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.149
71690219|NCT03060291|142896835|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.207|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.207
71690220|NCT03060291|142896835|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.871|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.871
71690221|NCT03060291|142896836|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.547|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.547
71690222|NCT03060291|142896836|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.575|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.575
71690223|NCT03060291|142896836|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.964|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.964
71690224|NCT03060291|142896837|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.236|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.236
71690225|NCT03060291|142896837|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.142|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.142
71690226|NCT03060291|142896837|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.81|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.810
71690227|NCT03060291|142896838|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.599|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.599
71690228|NCT03060291|142896838|SUPERIORITY||Mean Difference (Final Values)|0.22||||0.523|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.523
71690229|NCT03060291|142896838|SUPERIORITY||Mean Difference (Final Values)|0.36||||0.252|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the web/mobile only as the reference group.|||||.252
71690230|NCT03060291|142896839|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.867|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.867
71690231|NCT03060291|142896839|SUPERIORITY||Mean Difference (Final Values)|-0.47||||0.127|TWO_SIDED||||||t-test, 2 sided||Mean difference in slope with the wait-list control as the reference group.|||||.127
71931192|NCT03111407|143383584|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.6154|||||||t-test, 2 sided|||Knee Soceity Score Function 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 80.5 +/- 13.8 \[44\] (55.0, 80.0, 100.0), 95% C.I. (76.2, 84.7) Conventional group: 78.5 +/- 19.1 \[26\] (40.0, 80.0, 100.0),95% C.I. (70.8, 86.2)||||0.6154
71690232|NCT03060291|142896839|SUPERIORITY||Mean Difference (Final Values)|-0.51||||0.101|TWO_SIDED||||||t-test, 2 sided||||Mean difference in slope with the web/mobile only as the reference group.|||.101
71690233|NCT01556932|142896840|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.2541|||TWO_SIDED|||||||||||||
71690234|NCT01882803|142896841|OTHER||||||<=|0.0001||||||'\<=' represents '≤'|Exact Binomial Test|The p-value was calculated by 1-sided exact binomial test with the null hypothesis that ORR ≤30%.||ORR was tested against the null (≤30%) by 1-sided exact binomial test at 0.025 level.||||<=0.0001
71690235|NCT00705341|142896851|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Regression, Linear|||Log-linear generalized estimating equation (GEE) models were used to assess the dose effect on PC20.||||0.65
71690236|NCT00205660|142896877|SUPERIORITY|||||||0.03||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.03
71690237|NCT00205660|142896878|SUPERIORITY|||||||0.01||||||The a priori threshold for statistical significance in this planned primary test was p\<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).||||0.01
71690238|NCT01720524|142896882|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.985|TWO_SIDED|95.0|-2.08|2.04|||ANCOVA|||||2.04|-2.08|0.9850
71690239|NCT01720524|142896883|SUPERIORITY||Difference in percentage|7.6||||0.4935|TWO_SIDED|95.0|-14.1|29.3|||Chi-squared|||||29.3|-14.1|0.4935
71690240|NCT01720524|142896884|SUPERIORITY|||||||0.9885|||||||Log Rank|||||||0.9885
71690241|NCT01720524|142896885|SUPERIORITY|||||||0.491|||||||Log Rank|||||||0.4910
71690242|NCT01720524|142896886|SUPERIORITY||Difference in Percentage|3.8||||0.7065|TWO_SIDED|95.0|-15.2|22.9|||Fisher Exact|||Additional Treatment||22.9|-15.2|0.7065
71690243|NCT01720524|142896886|SUPERIORITY||Difference in Percentage|0.3|||>|0.999|TWO_SIDED|95.0|-18.5|18.5|||Fisher Exact|||ECMO||18.5|-18.5|>0.999
71690244|NCT01720524|142896886|SUPERIORITY||Difference in Percentage|6.9||||0.2373|TWO_SIDED|95.0|-5.5|22.8|||Fisher Exact|||Death||22.8|-5.5|0.2373
71690245|NCT01720524|142896887|SUPERIORITY||LS Mean Difference|3.9||||0.4984|TWO_SIDED|95.0|-7.5|15.3|||ANCOVA|||Hour 6||15.3|-7.5|0.4984
71690246|NCT01720524|142896887|SUPERIORITY||LS Mean Difference|4.1||||0.3956|TWO_SIDED|95.0|-5.5|13.7|||ANCOVA|||Hour 12||13.7|-5.5|0.3956
71690247|NCT01720524|142896887|SUPERIORITY||LS Mean Difference|-2.2||||0.4249|TWO_SIDED|95.0|-7.6|3.3|||ANCOVA|||Hour 24||3.3|-7.6|0.4249
71690248|NCT01720524|142896888|SUPERIORITY||LS Mean Difference|0.7||||0.7686|TWO_SIDED|95.0|-4.3|5.8|||ANCOVA|||Hour 6||5.8|-4.3|0.7686
71690249|NCT01720524|142896888|SUPERIORITY||LS Mean Difference|-8.0||||0.1112|TWO_SIDED|95.0|-17.8|1.9|||ANCOVA|||Hour 12||1.9|-17.8|0.1112
71690250|NCT01720524|142896888|SUPERIORITY||LS Mean Difference|-8.2||||0.2089|TWO_SIDED|95.0|-21.2|4.8|||ANCOVA|||Hour 24||4.8|-21.2|0.2089
71690251|NCT01720524|142896889|SUPERIORITY||LS Mean Difference|37.2||||0.0829|TWO_SIDED|95.0|-5.0|79.5|||ANCOVA|||Hour 6||79.5|-5.0|0.0829
71690252|NCT01720524|142896889|SUPERIORITY||LS Mean Difference|26.6||||0.1802|TWO_SIDED|95.0|-12.7|65.9|||ANCOVA|||Hour 12||65.9|-12.7|0.1802
71690253|NCT01720524|142896889|SUPERIORITY||LS Mean Difference|79.9||||0.1576|TWO_SIDED|95.0|-32.5|192.2|||ANCOVA|||Hour 24||192.2|-32.5|0.1576
71931193|NCT03111407|143383585|EQUIVALENCE|Data analyzed with SAS Enterprise Guided (version 7.15 HF3, SAS lnstitute lnc., Cary, NC). Significance level set with q = 0.05. Continuous data (e.g. age, weight, EQ-5D) were summarized using mean, standard deviation, minimum, median, maximum and number of observations. Comparison between continuous baseline and patient visits were performed using standard statistical tests (e.g., a t-test, Wilcoxon test, or one-way ANOVA (as appropriate) were performed as required to evaluate the difference).||||||0.4549|||||||t-test, 2 sided|||EQ-5D score 1 year post surgery: Mean+/- SD (N)(Min, Max) 95%C.I (lower, upper) iAssist group: 0.8 +/- 0.2 \[29\] (0.0, 1.0, 1.0), 95% C.I. (0.7, 0.9) Conventional group: 0.8 +/- 0.3 \[20\] (0.1, 0.8, 1.0), 95% C.I. (0.7, 0.9)||||0.4549
71931194|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.64||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.64|-0.94|<0.0001
71931195|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.06|-0.76||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.76|-1.06|<0.0001
71931196|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.52||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.52|-0.82|<0.0001
71931197|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.1245|TWO_SIDED|95.0|-0.27|0.03||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||0.03|-0.27|0.1245
71931198|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.0022|TWO_SIDED|95.0|-0.39|-0.09||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52||-0.09|-0.39|0.0022
71931199|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.41||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.41|-0.79|<0.0001
71931200|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.49||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.49|-0.87|<0.0001
71931201|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.48||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.48|-0.75|<0.0001
71931202|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.83|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.83|<0.0001
71931203|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.74|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.89|-0.59||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.59|-0.89|<0.0001
71931204|NCT01289990|143383586|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.55|-0.85|<0.0001
71931205|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.82|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.04|-0.61||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.61|-1.04|<0.0001
71931206|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-1.11|-0.69||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.69|-1.11|<0.0001
71931207|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.1||0.0322|TWO_SIDED|95.0|-0.41|-0.02||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.02|-0.41|0.0322
71931208|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.1||0.0038|TWO_SIDED|95.0|-0.48|-0.09||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.09|-0.48|0.0038
71931209|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.83|-0.4||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.40|-0.83|<0.0001
71931210|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.62|STANDARD_ERROR_OF_MEAN|0.15|<|0.0001|TWO_SIDED|95.0|-0.9|-0.33||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.33|-0.90|<0.0001
71931211|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-1.0|-0.44||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.44|-1.00|<0.0001
71931212|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.87|-0.47||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.47|-0.87|<0.0001
71931213|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.83|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-1.04|-0.63||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.63|-1.04|<0.0001
71690254|NCT00996034|142896914|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANOVA|||This is a comparison of scan 1 and scan 2||||<0.05
71931214|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.57||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.57|-1.04|<0.0001
71690255|NCT00527826|142896924|NON_INFERIORITY_OR_EQUIVALENCE|Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.73||95.0|||||Negative binomial model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.73
71690256|NCT00527826|142896926|NON_INFERIORITY_OR_EQUIVALENCE|Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.66||95.0|||||Poisson model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.||||||0.66
71690257|NCT00158262|142896939|SUPERIORITY||Mean Difference (Final Values)|7.0|||||TWO_SIDED|95.0|-2.7|16.7|||||Placebo-Propranolol|||16.7|-2.7|
71690258|NCT00158262|142896940|SUPERIORITY||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-15.5|15.3|||||Placebo-Propranolol|CAPS Total Score at Month 1||15.3|-15.5|
71690259|NCT00158262|142896940|SUPERIORITY||Mean Difference (Final Values)|-2.2|||||TWO_SIDED|95.0|-20.3|16.0||||||CAPS Total Score at Month 3||16.0|-20.3|
71690260|NCT00158262|142896941|SUPERIORITY||Mean Difference (Final Values)|2.9|||||TWO_SIDED|95.0|-4.8|10.7|||||Placebo-Propranolol|||10.7|-4.8|
71690261|NCT02585713|142896972|SUPERIORITY|||||||0.1316|||||||Log Rank|||||||0.1316
71931215|NCT01289990|143383587|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.8|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-1.04|-0.56||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis|||||-0.56|-1.04|<0.0001
71931216|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.6|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.8|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.8|<0.0001
71931217|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.2|STANDARD_ERROR_OF_MEAN|1.1||0.0001|TWO_SIDED|95.0|-6.4|-2.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.1|-6.4|0.0001
71931218|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|1.1||0.2107|TWO_SIDED|95.0|-3.5|0.8||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.8|-3.5|0.2107
71931219|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.3|STANDARD_ERROR_OF_MEAN|1.1||0.0033|TWO_SIDED|95.0|-5.4|-1.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.1|-5.4|0.0033
71931220|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.8|STANDARD_ERROR_OF_MEAN|1.1||0.0105|TWO_SIDED|95.0|-5.0|-0.7||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-5.0|0.0105
71690262|NCT03173456|142896975|SUPERIORITY|||||||0.69||||||A priori threshold for statistical significance was 0.05. The plan was to only do individual comparisons between means if the overall test of the analysis of variance (AVOVA) was statistically significant|ANOVA|||The null hypothesis is that all means are equal. The alternate hypothesis is that one or more mean is less than or more than another.||||0.69
71690263|NCT03173456|142896976|SUPERIORITY|||||||0.85||||||Threshold for statistical significance was 0.05. The plan was to only compare means if the overall test of AVOVA was statistically significant.|ANOVA|||||||0.85
71690264|NCT03173456|142896977|SUPERIORITY|||||||0.99||||||Threshold for statistical significance = 0.05|Chi-squared|||||||0.99
71690265|NCT03173456|142896979|SUPERIORITY|||||||0.46|||||||Chi-squared|||||||0.46
71690266|NCT03173456|142896980|SUPERIORITY|||||||0.0501||||||0.05 was the a priori threshold for statistical significance|Chi-squared|||||||0.0501
71690267|NCT01733121|142896981|OTHER||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|0.7|<|0.0001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<.0001
71690268|NCT01733121|142896982|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.4|||ANOVA|||||-0.4|-1.2|<0.0001
71690269|NCT01733121|142896983|OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.7||0.0005|TWO_SIDED|95.0|-3.7|-1.1|||ANCOVA|||||-1.1|-3.7|0.0005
71690270|NCT01733121|142896984|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.2|-0.5|||ANOVA|||||-0.5|-1.2|<.0001
71690271|NCT04501952|142897001|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% confidence interval (CI) were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
71690272|NCT04501952|142897003|SUPERIORITY||Hazard Ratio (HR)|0.191||||0.0024|TWO_SIDED|95.0|0.065|0.555|||Regression, Cox|P-value was estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.555|0.065|0.0024
71690273|NCT04501952|142897006|SUPERIORITY||Hazard Ratio (HR)|0.134||||0.0076|TWO_SIDED|95.0|0.031|0.586|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.586|0.031|0.0076
71690274|NCT04501952|142897007|SUPERIORITY||Hazard Ratio (HR)|0.1||||0.0019|TWO_SIDED|95.0|0.023|0.43|||Regression, Cox|P-value were estimated using the Cox regression with baseline stratification factors as covariates.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||0.430|0.023|0.0019
71690275|NCT04501952|142897008|SUPERIORITY||Least Squares Mean|0.07|STANDARD_ERROR_OF_MEAN|0.09||0.4318|TWO_SIDED|95.0|-0.1|0.24|||ANCOVA|P-value were from an ANCOVA model with baseline viral load as a covariate.|Least squares Mean (LSM), standard error (SE) and 95% CI were from an ANCOVA model with baseline viral load as a covariate.|||0.24|-0.10|0.4318
71690276|NCT04501952|142897009|SUPERIORITY||Hazard Ratio (HR)|1.405||||0.2987|TWO_SIDED|95.0|0.733|2.693|||Log Rank|p-value was based on stratified log-rank test with baseline stratification factor as strata.|Hazard ratio and two-sided 95% CI were estimated using the Cox regression with baseline stratification factors as covariates.|||2.693|0.733|0.2987
71690277|NCT04501952|142897011|SUPERIORITY|||||||0.2163|||||||Fisher Exact|||||||0.2163
71690278|NCT00436826|142897035|SUPERIORITY||Relative Risk|0.37|||<|0.001|TWO_SIDED|95.0|0.22|0.63|||Wald Chi-square|||||0.63|0.22|<0.001
71690279|NCT00784719|142897055|SUPERIORITY_OR_OTHER||Median|59.0|||||TWO_SIDED|80.0|57.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||57.0|
71690280|NCT00784719|142897055|SUPERIORITY_OR_OTHER||Median|58.0|||||TWO_SIDED|80.0|58.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||58.0|
71690281|NCT00784719|142897055|SUPERIORITY_OR_OTHER||Median|57.0|||||TWO_SIDED|80.0|29.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved \>=10 mm Schirmer test score in this reporting group, for the analysis.||||||||29.0|
71690282|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|9.0|28.0||||||||28.0|9.0|
71690283|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|8.5|||||TWO_SIDED|80.0|8.0|27.0||||||||27.0|8.0|
71690284|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|15.0|27.0||||||||27.0|15.0|
71931221|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.0543|TWO_SIDED|95.0|-4.9|0.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-4.9|0.0543
71931222|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.2||0.0019|TWO_SIDED|95.0|-6.4|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-6.4|0.0019
71690285|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|9.5|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
71931223|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.0|STANDARD_ERROR_OF_MEAN|1.0||0.0045|TWO_SIDED|95.0|-5.0|-0.9||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-5.0|0.0045
71931224|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.5|STANDARD_ERROR_OF_MEAN|1.0|<|0.0001|TWO_SIDED|95.0|-6.6|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.5|-6.6|<0.0001
71931225|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.9|STANDARD_ERROR_OF_MEAN|1.0||0.0031|TWO_SIDED|95.0|-4.8|-1.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-4.8|0.0031
71931226|NCT01289990|143383588|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.5|STANDARD_ERROR_OF_MEAN|1.0||0.0096|TWO_SIDED|95.0|-4.4|-0.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-4.4|0.0096
71931227|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.78|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.94|-0.63||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.63|-0.94|<0.0001
71931228|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-1.04|-0.73||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.73|-1.04|<0.0001
71931229|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.66|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.82|-0.51||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.51|-0.82|<0.0001
71931230|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.08||0.131|TWO_SIDED|95.0|-0.28|0.04||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||0.04|-0.28|0.1310
71931231|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.005|TWO_SIDED|95.0|-0.38|-0.07||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.07|-0.38|0.0050
71931232|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.79|-0.4||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.40|-0.79|<0.0001
71931233|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.1|<|0.0001|TWO_SIDED|95.0|-0.88|-0.5||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.50|-0.88|<0.0001
71931234|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.75|-0.46||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.46|-0.75|<0.0001
71931235|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.73|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.88|-0.58||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.58|-0.88|<0.0001
71690286|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|9.0|||||TWO_SIDED|80.0|8.0|15.0||||||||15.0|8.0|
71931236|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.87|-0.56|||ANCOVA|||||-0.56|-0.87|<0.0001
71931237|NCT01289990|143383589|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.85|-0.53||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||||-0.53|-0.85|<0.0001
71931238|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0025|TWO_SIDED|95.0|-5.5|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.5|0.0025
71931239|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.4|STANDARD_ERROR_OF_MEAN|1.1||0.0021|TWO_SIDED|95.0|-5.6|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-5.6|0.0021
71931240|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|1.1||0.7241|TWO_SIDED|95.0|-1.8|2.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||2.6|-1.8|0.7241
71931241|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-5.9|0.0008
71931242|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.8|STANDARD_ERROR_OF_MEAN|1.1||0.0007|TWO_SIDED|95.0|-6.0|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.6|-6.0|0.0007
71931243|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|1.2||0.0987|TWO_SIDED|95.0|-4.5|0.4||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-4.5|0.0987
71931244|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.2||0.0028|TWO_SIDED|95.0|-6.1|-1.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.3|-6.1|0.0028
71931245|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-4.4|STANDARD_ERROR_OF_MEAN|1.1|<|0.0001|TWO_SIDED|95.0|-6.6|-2.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.3|-6.6|<0.0001
71931246|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.7|STANDARD_ERROR_OF_MEAN|1.1||0.0008|TWO_SIDED|95.0|-5.9|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.5|-5.9|0.0008
71931247|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|1.0||0.0213|TWO_SIDED|95.0|-4.1|-0.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-4.1|0.0213
71931248|NCT01289990|143383590|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|1.0||0.0288|TWO_SIDED|95.0|-4.1|-0.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-4.1|0.0288
71931249|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.1058|TWO_SIDED|95.0|-2.4|0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-2.4|0.1058
71931250|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0109|TWO_SIDED|95.0|-3.1|-0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-3.1|0.0109
71931251|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.8259|TWO_SIDED|95.0|-1.5|1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.2|-1.5|0.8259
71931252|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.166|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1660
71931253|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0212|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0212
71931254|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0076|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0076
71931255|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.6|STANDARD_ERROR_OF_MEAN|0.7||0.0003|TWO_SIDED|95.0|-4.1|-1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.2|-4.1|0.0003
71690287|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|15.0|||||TWO_SIDED|80.0|8.0|43.0||||||||43.0|8.0|
71690288|NCT00784719|142897057|SUPERIORITY_OR_OTHER||Median|16.0|||||TWO_SIDED|80.0|15.0|30.0||||||||30.0|15.0|
71690289|NCT05464420|142897088|OTHER|Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|6.0|||||TWO_SIDED|95.0|3.0|8.6||||||Injection site erythema: V116 Combined Lots - PPSV23||8.6|3.0|
71690290|NCT05464420|142897088|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|12.6|||||TWO_SIDED|95.0|8.0|17.3||||||Injection site pain: V116 Combined Lots - PPSV23||17.3|8.0|
71690291|NCT05464420|142897088|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.6|||||TWO_SIDED|95.0|2.6|8.2||||||Injection site swelling: V116 Combined Lots - PPSV23||8.2|2.6|
71690292|NCT05464420|142897090|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|1.4|||||TWO_SIDED|95.0|-3.2|6.0||||||Fatigue: V116 Combined Lots - PPSV23||6.0|-3.2|
71690293|NCT05464420|142897090|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|5.8|||||TWO_SIDED|95.0|1.6|9.7||||||Headache: V116 Combined Lots - PPSV23||9.7|1.6|
71690294|NCT05464420|142897090|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|7.6|||||TWO_SIDED|95.0|4.5|10.5||||||Myalgia: V116 Combined Lots - PPSV23||10.5|4.5|
71690295|NCT05464420|142897090|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.8|||||TWO_SIDED|95.0|-1.0|2.1||||||Pyrexia: V116 Combined Lots - PPSV23||2.1|-1.0|
71690296|NCT05464420|142897092|OTHER|Estimated difference in percentage and 95% CI were based on the Miettinen \& Nurminen method.|Estimated difference in percentage|0.0|||||TWO_SIDED|95.0|-0.7|0.2||||||Vaccine-related SAEs: V116 Combined Lots - PPSV23||0.2|-0.7|
71931256|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.8|STANDARD_ERROR_OF_MEAN|0.7||0.017|TWO_SIDED|95.0|-3.2|-0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-3.2|0.0170
71690297|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.96|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2||1.24|0.96|<0.001
71690298|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.9|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.90|<0.001
71690299|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.83|1.06||Identical p-values for the lower and upper bounds.|cLDA Model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.83|<0.001
71690300|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.97|1.35||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.35|0.97|<0.001
71690301|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.88|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.22|0.88|<0.001
71931257|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.7||0.0236|TWO_SIDED|95.0|-3.1|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-3.1|0.0236
71931258|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2523|TWO_SIDED|95.0|-2.0|0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.5|-2.0|0.2523
71690302|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.91|||<|0.001|TWO_SIDED|95.0|0.77|1.06||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3||1.06|0.77|<0.001
71931259|NCT01289990|143383591|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.6|STANDARD_ERROR_OF_MEAN|0.6||0.3494|TWO_SIDED|95.0|-1.9|0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.7|-1.9|0.3494
71931260|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1568|TWO_SIDED|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.3|0.1568
71690303|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.16|||<|0.001|TWO_SIDED|95.0|1.01|1.34||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 7F: V116 Lot 1/ V116 Lot 2||1.34|1.01|<0.001
71690304|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.94|1.25||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3||1.25|0.94|<0.001
71690305|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3||1.07|0.81|<0.001
71690306|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.92|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 8 V116 Lot 1/V116 Lot 2||1.16|0.92|<0.001
71690307|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.93|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.93|<0.001
71690308|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.9|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/ V116 Lot 3|Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3||1.14|0.90|<0.001
71690309|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2||1.26|0.94|<0.001
71690310|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3||1.17|0.87|<0.001
71690311|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.8|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.80|<0.001
71690312|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.85|<0.001
71931261|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.7||0.1323|TWO_SIDED|95.0|-2.4|0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.3|-2.4|0.1323
71931262|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.5|STANDARD_ERROR_OF_MEAN|0.7||0.4327|TWO_SIDED|95.0|-0.8|1.9||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.9|-0.8|0.4327
71931263|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.7||0.0289|TWO_SIDED|95.0|-2.8|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.8|0.0289
71931264|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.7||0.0231|TWO_SIDED|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-2.9|0.0231
71931265|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.8||0.0513|TWO_SIDED|95.0|-3.0|0.0||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.0|-3.0|0.0513
71931266|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.2|STANDARD_ERROR_OF_MEAN|0.8||0.0038|TWO_SIDED|95.0|-3.7|-0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-3.7|0.0038
71931267|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.7||0.0084|TWO_SIDED|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-3.4|0.0084
71931268|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.7||0.0677|TWO_SIDED|95.0|-2.8|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.8|0.0677
71931269|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.7||0.0814|TWO_SIDED|95.0|-2.4|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.4|0.0814
71931270|NCT01289990|143383592|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.7||0.1785|TWO_SIDED|95.0|-2.2|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.4|-2.2|0.1785
71931271|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.22|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.75|-1.69||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.69|-2.75|<0.0001
71931272|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.14|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.66|-1.61||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.61|-2.66|<0.0001
71931273|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.62|STANDARD_ERROR_OF_MEAN|0.27||0.0223|TWO_SIDED|95.0|0.09|1.14||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.14|0.09|0.0223
71931274|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.84|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.37|-2.31||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.31|-3.37|<0.0001
71931275|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.75|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-3.28|-2.22|||ANCOVA|||||-2.22|-3.28|<0.0001
71690313|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3||1.18|0.91|<0.001
71931276|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.09|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.76|-1.41||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.41|-2.76|<0.0001
71931277|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.99|STANDARD_ERROR_OF_MEAN|0.34|<|0.0001|TWO_SIDED|95.0|-2.66|-1.32||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.32|-2.66|<0.0001
71931278|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.73|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.27|-1.19||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.19|-2.27|<0.0001
71931279|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.3|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.85|-1.76||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.76|-2.85|<0.0001
71931280|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.48|-1.47||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.47|-2.48|<0.0001
71931281|NCT01289990|143383593|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.01|STANDARD_ERROR_OF_MEAN|0.26|<|0.0001|TWO_SIDED|95.0|-2.52|-1.5||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.50|-2.52|<0.0001
71931282|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.35|-1.26||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.26|-2.35|<0.0001
71931283|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.02|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.56|-1.48||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.48|-2.56|<0.0001
71931284|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.28||0.0546|TWO_SIDED|95.0|-0.01|1.08||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.08|-0.01|0.0546
71931285|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.34|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-2.89|-1.8||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.80|-2.89|<0.0001
71931286|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.56|STANDARD_ERROR_OF_MEAN|0.28|<|0.0001|TWO_SIDED|95.0|-3.1|-2.01||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-2.01|-3.10|<0.0001
71931287|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.97|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.69|-1.24||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.24|-2.69|<0.0001
71931288|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.37|<|0.0001|TWO_SIDED|95.0|-2.43|-0.99||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.99|-2.43|<0.0001
71931289|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.93|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.52|-1.34||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.34|-2.52|<0.0001
71931290|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|95.0|-2.79|-1.6||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.60|-2.79|<0.0001
71931291|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.81|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.34|-1.27||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.27|-2.34|<0.0001
71931292|NCT01289990|143383594|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.27|<|0.0001|TWO_SIDED|95.0|-2.18|-1.11||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.11|-2.18|<0.0001
71931293|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
71931294|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0015|TWO_SIDED|95.0|-2.8|-0.7||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.7|-2.8|0.0015
71931295|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.5||0.5052|TWO_SIDED|95.0|-0.7|1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.4|-0.7|0.5052
71931296|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|-3.5|-1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.4|-3.5|<0.0001
71931297|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.5||0.0001|TWO_SIDED|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.1|0.0001
71931298|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.5||0.0064|TWO_SIDED|95.0|-2.6|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.6|0.0064
71931299|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.5||0.0642|TWO_SIDED|95.0|-2.1|0.1||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.1|-2.1|0.0642
71931300|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0053|TWO_SIDED|95.0|-1.8|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.8|0.0053
71931301|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.3|-0.9|||ANCOVA|||||-0.9|-2.3|<0.0001
71931302|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.001|TWO_SIDED|95.0|-2.1|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.1|0.0010
71931303|NCT01289990|143383595|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.4||0.0015|TWO_SIDED|95.0|-2.1|-0.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.5|-2.1|0.0015
71931304|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.5||0.0028|TWO_SIDED|95.0|-2.7|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.7|0.0028
71931305|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7|STANDARD_ERROR_OF_MEAN|0.5||0.0019|TWO_SIDED|95.0|-2.8|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.6|-2.8|0.0019
71931306|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.4|STANDARD_ERROR_OF_MEAN|0.6||0.5044|TWO_SIDED|95.0|-0.7|1.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||1.5|-0.7|0.5044
71931307|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.0|STANDARD_ERROR_OF_MEAN|0.6||0.0003|TWO_SIDED|95.0|-3.1|-0.9||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.9|-3.1|0.0003
71931308|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1|STANDARD_ERROR_OF_MEAN|0.6||0.0002|TWO_SIDED|95.0|-3.2|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-1.0|-3.2|0.0002
71931309|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.4|STANDARD_ERROR_OF_MEAN|0.6||0.0109|TWO_SIDED|95.0|-2.5|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-2.5|0.0109
71931310|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.1238|TWO_SIDED|95.0|-1.9|0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||0.2|-1.9|0.1238
71931311|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.8||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.8|-2.4|<0.0001
71931312|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.4||0.0076|TWO_SIDED|95.0|-1.9|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.3|-1.9|0.0076
71761224|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0054|TWO_SIDED|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.||-0.2|-1.0|0.0054
71931313|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.4||0.0049|TWO_SIDED|95.0|-2.1|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.4|-2.1|0.0049
71931314|NCT01289990|143383596|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.4||0.0178|TWO_SIDED|95.0|-1.9|-0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-0.2|-1.9|0.0178
71931315|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-32.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-37.8|-26.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-26.7|-37.8|<0.0001
71931316|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-37.2|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-42.8|-31.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-31.7|-42.8|<0.0001
71931317|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-17.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-22.9|-11.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-11.7|-22.9|<0.0001
71931318|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.0|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-20.6|-9.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.4|-20.6|<0.0001
71931319|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-19.9|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-25.5|-14.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-14.4|-25.5|<0.0001
71931320|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.1|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-35.0|-19.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.2|-35.0|<0.0001
71931321|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|4.0|<|0.0001|TWO_SIDED|95.0|-38.9|-23.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-23.2|-38.9|<0.0001
71931322|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-24.3|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-29.7|-18.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-18.9|-29.7|<0.0001
71931323|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.3|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-32.7|-21.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-21.9|-32.7|<0.0001
71931324|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.8|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-33.6|-22.0||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.0|-33.6|<0.0001
71931325|NCT01289990|143383597|SUPERIORITY_OR_OTHER||Adjusted mean difference|-28.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-34.5|-22.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-22.8|-34.5|<0.0001
71931326|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.7|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-37.4|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-37.4|<0.0001
71931327|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-34.9|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-40.7|-29.1||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-29.1|-40.7|<0.0001
71931328|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-16.3|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-22.1|-10.5||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-10.5|-22.1|<0.0001
71690314|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.06|||<|0.001|TWO_SIDED|95.0|0.93|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3||1.21|0.93|<0.001
71931329|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-15.4|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-21.2|-9.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-9.6|-21.2|<0.0001
71931330|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-18.7|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|95.0|-24.5|-12.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-12.8|-24.5|<0.0001
71931331|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-23.3|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-31.4|-15.3||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-15.3|-31.4|<0.0001
71931332|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-27.4|STANDARD_ERROR_OF_MEAN|4.1|<|0.0001|TWO_SIDED|95.0|-35.4|-19.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.4|-35.4|<0.0001
71931333|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-25.1|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-30.5|-19.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-19.6|-30.5|<0.0001
71931334|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.4|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-36.9|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.9|-36.9|<0.0001
71931335|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.0|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.0|-24.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-24.9|-37.0|<0.0001
71931336|NCT01289990|143383598|SUPERIORITY_OR_OTHER||Adjusted mean difference|-31.8|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-37.9|-25.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA|||||-25.7|-37.9|<0.0001
71931337|NCT01488071|143383599|NON_INFERIORITY_OR_EQUIVALENCE|"Mixed model for repeated measurements (MMRM), using all available data, with a freely varying mean and covariance structures and with treatment, week, and site group as fixed factors and the baseline score as a covariate. The model also included interaction between week and baseline score, as well as interaction between week and treatment.~Non-inferiority, upper limit of Confidence Interval should not exceed 2."|Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.69||0.0018|TWO_SIDED|95.0|-3.51|-0.81||Under established non-inferiority the p-value is not adjusted.|Mixed Models Analysis|MMRM||||-0.81|-3.51|0.0018
71931338|NCT01488071|143383600|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.03|STANDARD_ERROR_OF_MEAN|0.72||0.0054|TWO_SIDED|95.0|-3.45|-0.6||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.60|-3.45|0.0054
71931339|NCT01488071|143383601|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.56||0.0008|TWO_SIDED|95.0|-2.98|-0.8||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.80|-2.98|0.0008
71931340|NCT01488071|143383602|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.57||0.0007|TWO_SIDED|95.0|-3.04|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.04|0.0007
71931341|NCT01488071|143383603|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0023|TWO_SIDED|95.0|-0.48|-0.11||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.11|-0.48|0.0023
71931342|NCT01488071|143383604|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.1||0.0075|TWO_SIDED|95.0|-0.47|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.47|0.0075
71931343|NCT01488071|143383605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0048|TWO_SIDED|95.0|-0.42|-0.08||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.08|-0.42|0.0048
71931344|NCT01488071|143383606|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.09||0.0055|TWO_SIDED|95.0|-0.42|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.07|-0.42|0.0055
71931345|NCT01488071|143383607|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0012|TWO_SIDED|95.0|1.26|2.6||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.60|1.26|0.0012
71931346|NCT01488071|143383608|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.83||||0.0014|TWO_SIDED|95.0|1.26|2.65||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.65|1.26|0.0014
71931347|NCT01488071|143383609|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0054|TWO_SIDED|95.0|1.17|2.52||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.52|1.17|0.0054
71931348|NCT01488071|143383610|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0002|TWO_SIDED|95.0|1.39|2.9||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic|||||2.90|1.39|0.0002
71931349|NCT01488071|143383611|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22|STANDARD_ERROR_OF_MEAN|0.72||0.0021|TWO_SIDED|95.0|-3.63|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.81|-3.63|0.0021
71931350|NCT01488071|143383612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|STANDARD_ERROR_OF_MEAN|0.75||0.0209|TWO_SIDED|95.0|-3.23|-0.27||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.||||-0.27|-3.23|0.0209
71931351|NCT04355767|143383630|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.|A Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
71931352|NCT04355767|143383630|SUPERIORITY||Risk Difference (RD)|2.2|||||TWO_SIDED|95.0|-5.9|10.4|||||Risk difference after adjustment for age, sex, symptom duration.|Analysis is of patients with a disease-progression event.||10.4|-5.9|
71931353|NCT04355767|143383631|SUPERIORITY|||||||||||||||||Analysis is of patients with a disease-progression event.|A Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.|||
71931354|NCT04355767|143383633|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.69|1.17||||||||1.17|0.69|
71931355|NCT04355767|143383634|OTHER||Mean Difference (Final Values)|0.3|||||TWO_SIDED|95.0|-0.4|1.1||||||||1.1|-0.4|
71931356|NCT03302299|143383638|SUPERIORITY||Odds Ratio (OR)|1.59|||<|0.01|TWO_SIDED|95.0|0.94|2.71||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR for participants with moderate alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||2.71|0.94|<0.01
71931357|NCT03302299|143383638|SUPERIORITY||Odds Ratio (OR)|2.78|||<|0.01|TWO_SIDED|95.0|1.62|4.76||global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence.|Regression, Logistic||OR is for participants with unhealthy alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months.|||4.76|1.62|<0.01
71931358|NCT04318535|143383644|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of Cmax falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.157|||||TWO_SIDED|90.0|1.103|1.213|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.213|1.103|
71931359|NCT04318535|143383645|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-t) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.032|||||TWO_SIDED|90.0|0.974|1.094|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.094|0.974|
71931360|NCT04318535|143383646|EQUIVALENCE|Bioequivalence was to be determined if the 90% confidence interval of the geometric least square mean ratio of AUC(0-inf) falls within the 0.80-1.25 range.|Ratio of geometric least square mean|1.03|||||TWO_SIDED|90.0|0.971|1.093|||||T1 versus R was the primary interest of comparison for this outcome measure.|||1.093|0.971|
71931361|NCT01901146|143383656|EQUIVALENCE|The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).|Risk Difference (RD)|7.3||||0.0508|TWO_SIDED|90.0|1.2|13.4|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.4|1.2|0.0508
71931362|NCT01901146|143383656|EQUIVALENCE|If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.|Risk Ratio (RR)|1.1877||||0.043|TWO_SIDED|90.0|1.0327|1.366|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3660|1.0327|0.0430
71931363|NCT01901146|143383657|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|6.0||||0.1086|TWO_SIDED|90.0|-0.2|12.2|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||12.2|-0.2|0.1086
71690315|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2||1.11|0.84|<0.001
71690316|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3||1.16|0.87|<0.001
71931364|NCT01901146|143383657|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.1463||||0.0807|TWO_SIDED|90.0|1.008|1.3035|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.3035|1.0080|0.0807
71931365|NCT01901146|143383658|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|8.0||||0.0253|TWO_SIDED|90.0|2.1|13.9|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||13.9|2.1|0.0253
71931366|NCT01901146|143383658|OTHER|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.2746||||0.0245|TWO_SIDED|90.0|1.0673|1.5222|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.||1.5222|1.0673|0.0245
71931367|NCT00606801|143383659|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.006
71931368|NCT00606801|143383660|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.04
71690317|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.9|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.90|<0.001
71690318|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.96|1.26||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2||1.26|0.96|<0.001
71931369|NCT00606801|143383661|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.02
71931370|NCT00606801|143383662|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.03
71931371|NCT00606801|143383663|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
71931372|NCT00606801|143383664|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.7
71931373|NCT00606801|143383665|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
71690319|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
71931374|NCT00606801|143383666|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
71931375|NCT00606801|143383667|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.3
71931376|NCT00606801|143383668|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.9
71931377|NCT00606801|143383669|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.8
71931378|NCT00606801|143383670|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.5
71931379|NCT00606801|143383671|SUPERIORITY_OR_OTHER_LEGACY|||||||0.01|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.01
71931380|NCT00606801|143383672|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.60
71931381|NCT00606801|143383673|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p\<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.||||0.50
71931382|NCT02413879|143383687|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
71931383|NCT02413879|143383689|SUPERIORITY||||||<|0.001|||||||McNemar|||||||<0.001
71931384|NCT02533505|143383690|SUPERIORITY||Mean Difference (Final Values)|10.114||||0.007|TWO_SIDED|95.0|2.943|17.286||All p-values ≤ 0.05 after rounding will be considered statistically significant.|Mixed Models Analysis|||||17.286|2.943|0.007
71931385|NCT02533505|143383691|SUPERIORITY||Mean Difference (Final Values)|0.087||||0.111|TWO_SIDED|95.0|-0.021|0.196|||Mixed Models Analysis|||||0.196|-0.021|0.111
71931386|NCT02533505|143383692|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.609|TWO_SIDED|95.0|-1.018|1.719|||Mixed Models Analysis|||ΔHR||1.719|-1.018|0.609
71931387|NCT02533505|143383693|SUPERIORITY||Mean Difference (Final Values)|0.191|||<|0.001|TWO_SIDED|95.0|0.15|0.233|||Mixed Models Analysis|||ΔFEV1||0.233|0.150|<0.001
71931388|NCT02533505|143383693|SUPERIORITY||Mean Difference (Final Values)|0.312|||<|0.001|TWO_SIDED|95.0|0.236|0.388|||Mixed Models Analysis|||ΔFVC||0.388|0.236|<0.001
71931389|NCT02533505|143383693|SUPERIORITY||Mean Difference (Final Values)|0.28|||<|0.001|TWO_SIDED|95.0|0.218|0.342|||Mixed Models Analysis|||ΔIC||0.342|0.218|<0.001
71690320|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.81|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3||1.07|0.81|<0.001
71931390|NCT02533505|143383694|SUPERIORITY||Mean Difference (Final Values)|23.315||||0.021|TWO_SIDED|95.0|3.723|42.907|||Mixed Models Analysis|||ΔVT/Ti||42.907|3.723|0.021
71931391|NCT02533505|143383695|SUPERIORITY||Mean Difference (Final Values)|-0.204||||0.106|TWO_SIDED|95.0|-0.454|0.045|||Mixed Models Analysis|||||0.045|-0.454|0.106
71931392|NCT02533505|143383696|SUPERIORITY||Mean Difference (Final Values)|10.245||||0.011|TWO_SIDED|95.0|2.469|18.021|||Mixed Models Analysis|||ΔVCO2||18.021|2.469|0.011
71931393|NCT02533505|143383697|SUPERIORITY||Mean Difference (Final Values)|0.242||||0.333|TWO_SIDED|95.0|-0.255|0.738|||Mixed Models Analysis|||ΔSaO2||0.738|-0.255|0.333
71931394|NCT02533505|143383698|SUPERIORITY||Mean Difference (Final Values)|0.237||||0.484|TWO_SIDED|95.0|-0.439|0.913|||Mixed Models Analysis|||ΔRR||0.913|-0.439|0.484
71931395|NCT02533505|143383699|SUPERIORITY||Mean Difference (Final Values)|0.016||||0.113|TWO_SIDED|95.0|-0.004|0.036|||Mixed Models Analysis|||ΔTi/Ttot||0.036|-0.004|0.113
71931396|NCT02533505|143383700|SUPERIORITY||Mean Difference (Final Values)|57.624|||<|0.001|TWO_SIDED|95.0|29.701|85.546|||Mixed Models Analysis|||ΔVt||85.546|29.701|<0.001
71931397|NCT02533505|143383701|SUPERIORITY||Mean Difference (Final Values)|862.157|||<|0.001|TWO_SIDED|95.0|439.817|1284.496|||Mixed Models Analysis|||ΔVe||1284.496|439.817|<0.001
71931398|NCT02533505|143383702|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.007|TWO_SIDED|95.0|0.005|0.033|||Mixed Models Analysis|||ΔFEV1/FVC||0.033|0.005|0.007
71931399|NCT01467570|143383749|NON_INFERIORITY_OR_EQUIVALENCE|The differences between study groups were considered significant when the p value was \<0.05 or when the 95% CI for RD or MD did not include 0 (equivalent to p \< 0.05).||||||0.28|||||||t-test, 1 sided|||||||0.28
71931400|NCT01222715|143383774|SUPERIORITY_OR_OTHER|||||||0.0124|TWO_SIDED|95.0|||||Log Rank|||The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.||||0.0124
71931401|NCT03555890|143383795|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.975|||||TWO_SIDED|90.0|0.948|1.003||||||||1.003|0.948|
71931402|NCT03555890|143383796|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.978|||||TWO_SIDED|90.0|0.958|0.998||||||||0.998|0.958|
71931403|NCT03555890|143383797|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.934|||||TWO_SIDED|90.0|0.875|0.998||||||||0.998|0.875|
71931404|NCT03555890|143383798|EQUIVALENCE|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.857|||||TWO_SIDED|90.0|0.815|0.902||||||||0.902|0.815|
71931405|NCT03372369|143383859|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.||||<0.0001
71931406|NCT03372369|143383859|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.||||<0.0001
71931407|NCT03372369|143383859|SUPERIORITY||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.||||<0.0001
71931408|NCT03372369|143383860|SUPERIORITY||||||<|0.001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.||||<0.001
71931409|NCT03372369|143383860|SUPERIORITY||||||<|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.||||<0.01
71931410|NCT03372369|143383860|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.||||>0.01
71931411|NCT03372369|143383861|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
71931412|NCT03372369|143383861|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
71931413|NCT03372369|143383861|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
71931414|NCT03372369|143383862|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.||||>0.01
71931415|NCT03372369|143383862|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.||||>0.01
71931416|NCT03372369|143383862|SUPERIORITY||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.||||>0.01
71931417|NCT02239601|143383863|OTHER||Odds Ratio (OR)|0.41||||0.053|TWO_SIDED|95.0|0.17|1.01|||Mixed Models Analysis|||||1.01|0.17|0.053
71931418|NCT04682639|143383882|OTHER||LS mean difference|-18.54||||0.0103|TWO_SIDED|95.0|-32.6|-4.49|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||-4.49|-32.60|0.0103
71931419|NCT04682639|143383882|OTHER||LS mean difference|-7.53||||0.2861|TWO_SIDED|95.0|-21.48|6.42|||ANCOVA||Estimates were from ANCOVA model for rank score of percent change from baseline in esophageal PEC.|||6.42|-21.48|0.2861
71931420|NCT04682639|143383883|OTHER||LS mean difference|2.38||||0.4894|TWO_SIDED|95.0|-4.43|9.19|||Linear mixed effects model|||||9.19|-4.43|0.4894
71931421|NCT04682639|143383883|OTHER||LS mean difference|4.7||||0.1671|TWO_SIDED|95.0|-2.0|11.41|||Linear mixed effects model|||||11.41|-2.00|0.1671
71931422|NCT04682639|143383884|OTHER||LS mean difference|-54.53||||0.0565|TWO_SIDED|95.0|-110.59|1.54|||ANCOVA|||||1.54|-110.59|0.0565
71931423|NCT04682639|143383884|OTHER||LS mean difference|-13.95||||0.6193|TWO_SIDED|95.0|-69.61|41.71|||ANCOVA|||||41.71|-69.61|0.6193
71931424|NCT04682639|143383885|OTHER||Adjusted difference from placebo|21.9||||0.0007|TWO_SIDED|95.0|9.23|34.57|||Mantel Haenszel|||||34.57|9.23|0.0007
71931425|NCT04682639|143383885|OTHER||Adjusted difference from placebo|13.85||||0.0121|TWO_SIDED|95.0|3.03|24.66|||Mantel Haenszel|||||24.66|3.03|0.0121
71931426|NCT04682639|143383886|OTHER||Adjusted difference from placebo|12.15||||0.0173|TWO_SIDED|95.0|2.15|22.16|||Mantel Haenszel|||||22.16|2.15|0.0173
71931427|NCT04682639|143383886|OTHER||Adjusted difference from placebo|8.37||||0.059|TWO_SIDED|95.0|-0.32|17.07|||Mantel Haenszel|||||17.07|-0.32|0.0590
71931428|NCT00883740|143383889|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.15|||<|0.0001|TWO_SIDED|95.0|-26.69|-11.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.61|-26.69|<0.0001
71931429|NCT00883740|143383890|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.54|||<|0.0001|TWO_SIDED|95.0|-23.29|-11.8||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-11.80|-23.29|<0.0001
71931430|NCT00883740|143383891|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.81||||0.3841|TWO_SIDED|95.0|-5.92|2.3||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||2.30|-5.92|0.3841
71931431|NCT00883740|143383892|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.54|||<|0.0001|TWO_SIDED|95.0|17.48|33.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||33.61|17.48|<0.0001
71931432|NCT00883740|143383893|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.42|||<|0.0001|TWO_SIDED|95.0|3.74|7.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||7.11|3.74|<0.0001
71931433|NCT00883740|143383894|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.41||||0.0135|TWO_SIDED|95.0|-4.31|-0.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.51|-4.31|0.0135
71931434|NCT00883740|143383895|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.53||||0.0008|TWO_SIDED|95.0|-2.41|-0.66||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.66|-2.41|0.0008
71931435|NCT00883740|143383896|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.18||||0.0447|TWO_SIDED|95.0|-14.18|-0.17||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||-0.17|-14.18|0.0447
71931436|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||0.3613|TWO_SIDED|95.0|-1.07|0.39||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 1||0.39|-1.07|0.3613
71690321|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.89|1.22||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2||1.22|0.89|<0.001
71690322|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.86|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.86|<0.001
71690323|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.96|||<|0.001|TWO_SIDED|95.0|0.82|1.12||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3||1.12|0.82|<0.001
71690324|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.15|||<|0.001|TWO_SIDED|95.0|0.95|1.38||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2||1.38|0.95|<0.001
71690325|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.18|||<|0.001|TWO_SIDED|95.0|0.97|1.42||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3||1.42|0.97|<0.001
71690326|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.85|1.23||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3||1.23|0.85|<0.001
71690327|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.84|<0.001
71690328|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.84|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3||1.11|0.84|<0.001
71690329|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.87|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3||1.15|0.87|<0.001
71690330|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.85|1.11||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2||1.11|0.85|<0.001
71690331|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.89|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3||1.17|0.89|<0.001
71690332|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.05|||<|0.001|TWO_SIDED|95.0|0.92|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3||1.20|0.92|<0.001
71690333|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.91|1.15||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2||1.15|0.91|<0.001
71690334|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.95|||<|0.001|TWO_SIDED|95.0|0.84|1.07||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3||1.07|0.84|<0.001
71690335|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.93|||<|0.001|TWO_SIDED|95.0|0.82|1.04||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3||1.04|0.82|<0.001
71690336|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.84|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2||1.14|0.84|<0.001
71690337|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.07|||<|0.001|TWO_SIDED|95.0|0.92|1.24||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3||1.24|0.92|<0.001
71690338|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.09|||<|0.001|TWO_SIDED|95.0|0.94|1.27||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3||1.27|0.94|<0.001
71690339|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.1|||<|0.001|TWO_SIDED|95.0|0.93|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2||1.29|0.93|<0.001
71690340|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.87|1.21||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3||1.21|0.87|<0.001
71690341|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.94|||<|0.001|TWO_SIDED|95.0|0.8|1.1||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3||1.10|0.80|<0.001
71931437|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.1||||0.0686|TWO_SIDED|95.0|-2.29|0.09||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 2||0.09|-2.29|0.0686
71931438|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.44||||0.0009|TWO_SIDED|95.0|-3.85|-1.03||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 3||-1.03|-3.85|0.0009
71690342|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cDLA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.85|<0.001
71690343|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.86|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.86|<0.001
71690344|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3||1.19|0.87|<0.001
71690345|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.22|||<|0.001|TWO_SIDED|95.0|1.0|1.48||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2||1.48|1.00|<0.001
71690346|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.98|||<|0.001|TWO_SIDED|95.0|0.8|1.19||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3||1.19|0.80|<0.001
71690347|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.8|||<|0.001|TWO_SIDED|95.0|0.66|0.97||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3||0.97|0.66|<0.001
71931439|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.52||||0.0002|TWO_SIDED|95.0|-5.33|-1.71||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 4||-1.71|-5.33|0.0002
71931440|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.01||||0.0065|TWO_SIDED|95.0|-5.16|-0.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 5||-0.86|-5.16|0.0065
71931441|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.89||||0.0024|TWO_SIDED|95.0|-6.36|-1.41||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 6||-1.41|-6.36|0.0024
71931442|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.59||||0.0366|TWO_SIDED|95.0|-5.01|-0.16||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 7||-0.16|-5.01|0.0366
71931443|NCT00883740|143383897|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.85||||0.0593|TWO_SIDED|95.0|-5.82|0.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 8||0.11|-5.82|0.0593
71931444|NCT00883740|143383898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.25||||0.1106|TWO_SIDED|95.0|-2.79|0.29||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 1||0.29|-2.79|0.1106
71931445|NCT00883740|143383898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.0|||<|0.0001|TWO_SIDED|95.0|-8.49|-3.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 2||-3.51|-8.49|<0.0001
71931446|NCT00883740|143383898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.83||||0.0004|TWO_SIDED|95.0|-10.53|-3.13||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 3||-3.13|-10.53|0.0004
71931447|NCT00883740|143383898|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.44||||0.0199|TWO_SIDED|95.0|-10.0|-0.88||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 4||-0.88|-10.00|0.0199
71931448|NCT00883740|143383899|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.14||||0.0024|TWO_SIDED|95.0|0.78|3.5||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||||3.50|0.78|0.0024
71931449|NCT00883740|143383900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.13||||0.0591|TWO_SIDED|95.0|-16.59|0.32||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||0.32|-16.59|0.0591
71931450|NCT00883740|143383900|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.81|||<|0.0001|TWO_SIDED|95.0|-27.43|-10.2||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-10.20|-27.43|<0.0001
71931451|NCT00883740|143383901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.47||||0.1101|TWO_SIDED|95.0|-12.2|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5||1.26|-12.20|0.1101
71931452|NCT00883740|143383901|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.39||||0.0002|TWO_SIDED|95.0|-20.36|-6.42||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11||-6.42|-20.36|0.0002
71931453|NCT00883740|143383902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.91|||<|0.0001|TWO_SIDED|95.0|0.58|1.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||1.24|0.58|<0.0001
71931454|NCT00883740|143383902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.14|||<|0.0001|TWO_SIDED|95.0|0.76|1.53||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||1.53|0.76|<0.0001
71931455|NCT00883740|143383902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.87|||<|0.0001|TWO_SIDED|95.0|0.46|1.28||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||1.28|0.46|<0.0001
71690348|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2||1.18|0.88|<0.001
71690349|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.88|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.88|<0.001
71690350|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.87|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.87|<0.001
71690351|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2||1.20|0.87|<0.001
71690352|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.02|||<|0.001|TWO_SIDED|95.0|0.87|1.2||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3||1.20|0.87|<0.001
71690353|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.85|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3||1.17|0.85|<0.001
71931456|NCT00883740|143383902|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.89|||<|0.0001|TWO_SIDED|95.0|0.51|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||1.26|0.51|<0.0001
71931457|NCT00883740|143383903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.66||||0.0001|TWO_SIDED|95.0|-11.44|-3.89||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-3.89|-11.44|0.0001
71690354|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.11|||<|0.001|TWO_SIDED|95.0|0.93|1.33||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2||1.33|0.93|<0.001
71690355|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.08|||<|0.001|TWO_SIDED|95.0|0.9|1.29||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3||1.29|0.90|<0.001
71690356|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.81|1.16||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3||1.16|0.81|<0.001
71931458|NCT00883740|143383903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.67||||0.0077|TWO_SIDED|95.0|-13.27|-2.07||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-2.07|-13.27|0.0077
71931459|NCT00883740|143383903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.68||||0.2196|TWO_SIDED|95.0|-14.81|3.44||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||3.44|-14.81|0.2196
71931460|NCT00883740|143383903|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.18||||0.0081|TWO_SIDED|95.0|-10.73|-1.64||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-1.64|-10.73|0.0081
71931461|NCT00883740|143383904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|||<|0.0001|TWO_SIDED|95.0|-1.02|-0.37||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-0.37|-1.02|<0.0001
71931462|NCT00883740|143383904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.71||||0.0001|TWO_SIDED|95.0|-1.06|-0.36||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-0.36|-1.06|0.0001
71931463|NCT00883740|143383904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.59||||0.0014|TWO_SIDED|95.0|-0.95|-0.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-0.24|-0.95|0.0014
71931464|NCT00883740|143383904|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.52||||0.0084|TWO_SIDED|95.0|-0.9|-0.14||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-0.14|-0.90|0.0084
71931465|NCT00883740|143383905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-18.27|||<|0.0001|TWO_SIDED|95.0|-27.02|-9.52||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||-9.52|-27.02|<0.0001
71931466|NCT00883740|143383905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.06||||0.0002|TWO_SIDED|95.0|-24.24|-7.87||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||-7.87|-24.24|0.0002
71931467|NCT00883740|143383905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.23||||0.0085|TWO_SIDED|95.0|-23.01|-3.46||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||-3.46|-23.01|0.0085
71931468|NCT00883740|143383905|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.25||||0.0102|TWO_SIDED|95.0|-18.01|-2.48||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||-2.48|-18.01|0.0102
71931469|NCT00883740|143383906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.82|||<|0.0001|TWO_SIDED|95.0|13.25|36.4||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1||36.40|13.25|<0.0001
71931470|NCT00883740|143383906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.4|||<|0.0001|TWO_SIDED|95.0|18.59|40.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2||40.21|18.59|<0.0001
71931471|NCT00883740|143383906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|26.79|||<|0.0001|TWO_SIDED|95.0|15.37|38.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3||38.21|15.37|<0.0001
71931472|NCT00883740|143383906|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.44|||<|0.0001|TWO_SIDED|95.0|15.03|35.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4||35.86|15.03|<0.0001
71931473|NCT01818414|143383907|SUPERIORITY_OR_OTHER|||||||0.17|||||||t-test, 2 sided|||||||0.17
71931474|NCT01818414|143383908|SUPERIORITY_OR_OTHER|||||||0.052|||||||t-test, 2 sided|||||||0.052
71931475|NCT03870737|143383913|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 24.81, df = 1/40.||Outcomes fitted via a mixed effects model with time as predictor.||||<.0001
71931476|NCT03870737|143383915|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|Time: F = 5.78, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.02
71931477|NCT03870737|143383916|SUPERIORITY|||||||0.0005|||||||Mixed Models Analysis|Time: F = 14.28, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.0005
71931478|NCT03870737|143383917|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Time: F = .19, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.67
71931479|NCT03870737|143383918|SUPERIORITY|||||||0.76|||||||Mixed Models Analysis|Time: F = .08, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.76
71931480|NCT03870737|143383919|SUPERIORITY|||||||0.8|||||||Mixed Models Analysis|Time: F = .06, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.||||.80
71931481|NCT02320838|143383939|OTHER||||||<|0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||<0.001
71931482|NCT02320838|143383940|OTHER|||||||0.04||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.04
71931483|NCT02320838|143383941|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
71931484|NCT02320838|143383942|OTHER|||||||0.001||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.001
71931485|NCT02320838|143383943|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0.05|t-test, 2 sided|||||||0.003
71931486|NCT02320838|143383944|OTHER|||||||0.023||||||A priori threshold for statistical significance. p\<0.05|Chi-squared|||||||0.023
71931487|NCT02320838|143383945|OTHER|||||||0.003||||||A priori threshold for statistical significance. p\<0,05|t-test, 2 sided|||||||0.003
71931488|NCT02320838|143383946|OTHER|||||||0.8||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.8
71931489|NCT02320838|143383947|OTHER|||||||0.02||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.02
71931490|NCT02320838|143383948|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
71931491|NCT02320838|143383949|OTHER|||||||0.8|||||||ANOVA|||||||0.8
71931492|NCT02320838|143383950|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
71931493|NCT02320838|143383951|OTHER|||||||0.4||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.4
71931494|NCT02320838|143383952|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
71931495|NCT02320838|143383953|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
71931496|NCT02320838|143383954|OTHER|||||||0.9||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.9
71931497|NCT02320838|143383955|OTHER|||||||0.5||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.5
71931498|NCT02320838|143383956|OTHER|||||||0.6||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.6
71931499|NCT02320838|143383957|OTHER|||||||0.1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.1
71931500|NCT02320838|143383958|OTHER|||||||0.2||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||0.2
71931501|NCT02320838|143383959|OTHER|||||||1||||||A priori threshold for statistical significance. p\<0.05|ANOVA|||||||1.0
71931502|NCT01227954|143383980|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||To detect a minimum relative 50% improvement leading to an absolute 15% mean relative decline (MRD) in HVLT-R DR, 51 analyzable patients were required to ensure 80% statistical power with 0.05 alpha. Assuming a death rate of 40% before 4 months (based on trial NCT00003563) and a 10% nonevaluable rate, the target sample size was 102. The target MRD was determined from NCT00003563 which demonstrated 30% MRD in HVLT-R DR score from baseline to 4 months, with a standard deviation of 41%.||||<0.001
71931503|NCT01227954|143383983|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and recursive partitioning analysis class (RPA) (I vs. II). Explanatory variables are reported separately and only if in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
71931504|NCT01227954|143383983|SUPERIORITY|||||||0.1961|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1961
71931505|NCT01227954|143383983|SUPERIORITY|||||||0.0715|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Primary site (lung) is reported here.||||0.0715
71931506|NCT01227954|143383983|SUPERIORITY|||||||0.0554|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic status (no symptoms) is reported here.||||0.0554
71931507|NCT01227954|143383984|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Intercept is reported here.||||<0.0001
71931508|NCT01227954|143383984|SUPERIORITY|||||||0.1579|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Time is reported here.||||0.1579
71931509|NCT01227954|143383984|SUPERIORITY|||||||0.0559|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Neurologic function status (some symptoms) is reported here.||||0.0559
71931510|NCT01227954|143383984|SUPERIORITY|||||||0.0749|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (\>= 60 vs. \<60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p\< 0.10, except time forced in the model.). Age (\>= 60) is reported here.||||0.0749
71931511|NCT03583931|143384037|SUPERIORITY|||||||0.61|||||||ANOVA|||||||0.61
71931512|NCT03583931|143384038|SUPERIORITY|||||||0.84|||||||ANOVA|||||||0.84
71931513|NCT03583931|143384043|SUPERIORITY|||||||0.48|||||||ANOVA|||||||0.48
71931514|NCT03583931|143384044|SUPERIORITY|||||||0.25|||||||ANOVA|||||||0.25
71931515|NCT03583931|143384045|SUPERIORITY|||||||0.45|||||||ANOVA|||||||0.45
71931516|NCT03583931|143384046|SUPERIORITY|||||||0.87|||||||ANOVA|||||||0.87
71931517|NCT02787785|143384048|SUPERIORITY||Cox Proportional Hazard|0.49||||0.354|TWO_SIDED|95.0|0.11|2.2|||Regression, Cox|||||2.20|0.11|0.354
71931518|NCT02787785|143384050|SUPERIORITY||Cox Proportional Hazard|0.37||||0.479|TWO_SIDED|95.0|0.02|5.88|||Regression, Cox|||||5.88|0.02|0.479
71931519|NCT04333199|143384070|SUPERIORITY||Odds Ratio (OR)|2.9903891|||<|0.001|TWO_SIDED|95.0|2.2805876|3.9211066||We used an a priori threshold of p \< .05.|Regression, Logistic|||||3.9211066|2.2805876|<0.001
71931520|NCT04333199|143384071|SUPERIORITY||Odds Ratio (OR)|1.1781659||||0.154|TWO_SIDED|95.0|0.9404654|1.4759445||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.4759445|0.9404654|0.154
71931521|NCT04333199|143384072|SUPERIORITY||Odds Ratio (OR)|0.9575636||||0.571|TWO_SIDED|95.0|0.8242111|1.1124918||We used an a priori threshold of p \< .05.|Regression, Logistic|||||1.1124918|0.8242111|0.571
71931522|NCT04333199|143384073|SUPERIORITY||Odds Ratio (OR)|1.8562672|||<|0.001|TWO_SIDED|95.0|1.5692523|2.1957769||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.1957769|1.5692523|<0.001
71931523|NCT04333199|143384075|SUPERIORITY||Odds Ratio (OR)|1.8542767|||<|0.001|TWO_SIDED|95.0|1.5220654|2.2589975||We used an a priori threshold of p \< .05.|Regression, Logistic|||||2.2589975|1.5220654|<0.001
71931524|NCT01032330|143384209|SUPERIORITY||Risk Difference (RD)|0.054||||0.004|ONE_SIDED|95.0|0.02||||One-sided Barnard's Test||||||0.020|0.004
71931525|NCT01032330|143384210|OTHER||cumulative probability|0.15|||||TWO_SIDED|95.0|0.1|0.22|||||Kaplan-Meier estimate of cumulative probability of deterioration by 3 years|||.22|.10|
71931526|NCT01032330|143384211|SUPERIORITY||Risk Difference (RD)|0.024||||0.27|TWO_SIDED|95.0|-0.038|0.094|||One-sided Barnard's Test|||||0.094|-0.038|0.27
71931527|NCT01032330|143384213|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
71931528|NCT01032330|143384214|OTHER|||||||0.38|||||||ANCOVA|||Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.||||0.38
71931529|NCT01032330|143384215|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
71931530|NCT01032330|143384216|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
71931531|NCT01032330|143384216|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
71931532|NCT01032330|143384217|OTHER||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||<.001
71690357|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.03|||<|0.001|TWO_SIDED|95.0|0.91|1.17||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 2|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2||1.17|0.91|<0.001
71690358|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.04|||<|0.001|TWO_SIDED|95.0|0.91|1.18||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 1/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3||1.18|0.91|<0.001
71690359|NCT05464420|142897093|EQUIVALENCE|Equivalence can be concluded if both the lower tailed and upper tailed p-values are \< 0.025.|GMT Ratio|1.01|||<|0.001|TWO_SIDED|95.0|0.89|1.14||Identical p-values for the lower and upper bounds.|cLDA model|P value for testing the lower bound of the 95% CI for GMT ratio was \>0.5. P value for testing the upper bound of the 95% CI for GMT ratio was \<2.0.|V116 Lot 2/V116 Lot 3|Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3||1.14|0.89|<0.001
71690360|NCT05464420|142897094|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
71690361|NCT05464420|142897094|OTHER||GMT Ratio|3.48|||||TWO_SIDED|95.0|3.01|4.02|||||V116 Combined Lots/PPSV23|Serotype 6A: GMT Ratio V116 Combined Lots/ PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.02|3.01|
71690362|NCT05464420|142897094|OTHER||GMT Ratio|1.33|||||TWO_SIDED|95.0|1.18|1.49|||||V116 Combined Lots/PPSV23|Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.49|1.18|
71690363|NCT05464420|142897094|OTHER||GMT Ratio|0.85|||||TWO_SIDED|95.0|0.77|0.93|||||V116 Combined Lots/PPSV23|Serotype 8: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.93|0.77|
71690364|NCT05464420|142897094|OTHER||GMT Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.08|||||V116 Combined Lots/PPSV23|Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.08|0.85|
71690365|NCT05464420|142897094|OTHER||GMT Ratio|1.32|||||TWO_SIDED|95.0|1.18|1.48|||||V116 Combined Lots/PPSV23|Serotype 10A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.48|1.18|
71690366|NCT05464420|142897094|OTHER||GMT Ratio|1.74|||||TWO_SIDED|95.0|1.56|1.95|||||V116 Combined Lots/PPSV23|Serotype 11A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.95|1.56|
71690367|NCT05464420|142897094|OTHER||GMT Ratio|1.38|||||TWO_SIDED|95.0|1.22|1.56|||||V116 Combined Lots/PPSV23|Serotype 12F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.56|1.22|
71690368|NCT05464420|142897094|OTHER||GMT Ratio|4.03|||||TWO_SIDED|95.0|3.56|4.56|||||V116 Combined Lots/PPSV23|Serotype 15A: GMT Ratio v116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.56|3.56|
71690369|NCT05464420|142897094|OTHER||GMT Ratio|2.9|||||TWO_SIDED|95.0|2.49|3.38|||||V116 Combined Lots/PPSV23|Serotype 15C: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|3.38|2.49|
71690370|NCT05464420|142897094|OTHER||GMT Ratio|3.72|||||TWO_SIDED|95.0|3.32|4.17||||||Serotype 16F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.17|3.32|
71690371|NCT05464420|142897094|OTHER||GMT Ratio|1.71|||||TWO_SIDED|95.0|1.53|1.91|||||V116 Combined Lots/PPSV23|Serotype 17F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.91|1.53|
71690372|NCT05464420|142897094|OTHER||GMT Ratio|0.93|||||TWO_SIDED|95.0|0.84|1.03|||||V116 Combined Lots/PPSV23|Serotype 19A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.03|0.84|
71690373|NCT05464420|142897094|OTHER||GMT Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.67|||||V116 Combined Lots/PPSV23|Serotype 20A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.67|1.30|
71690374|NCT05464420|142897094|OTHER||GMT Ratio|1.34|||||TWO_SIDED|95.0|1.17|1.53|||||V116 Combined Lots/PPSV23|Serotype 22F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|1.53|1.17|
71690375|NCT05464420|142897094|OTHER||GMT Ratio|7.98|||||TWO_SIDED|95.0|6.84|9.31|||||V116 Combined Lots/PPSV23|Serotype 23A: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|9.31|6.84|
71690376|NCT05464420|142897094|OTHER||GMT Ratio|23.72|||||TWO_SIDED|95.0|19.71|28.55|||||V116 Combined Lots/PPSV23|Serotype 23B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|28.55|19.71|
71690377|NCT05464420|142897094|OTHER||GMT Ratio|19.55|||||TWO_SIDED|95.0|16.7|22.88|||||V116 Combined Lots/PPSV23|Serotype 24F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|22.88|16.70|
71690378|NCT05464420|142897094|OTHER||GMT Ratio|13.55|||||TWO_SIDED|95.0|11.68|15.71|||||V116 Combined Lots/PPSV23|Serotype 31: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|15.71|11.68|
71690379|NCT05464420|142897094|OTHER||GMT Ratio|0.84|||||TWO_SIDED|95.0|0.73|0.97||||||Serotype 33F: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|0.97|0.73|
71690380|NCT05464420|142897094|OTHER||GMT Ratio|3.71|||||TWO_SIDED|95.0|3.36|4.09|||||V116 Combined Lots/PPSV23|Serotype 35B: GMT Ratio V116 Combined Lots / PPSV23|GMT Ratio and 95% CI were estimated from a cLDA model.|4.09|3.36|
71690381|NCT05464420|142897095|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.88|1.09|||||V116 Lot 1/V116 Lot 2|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.09|0.88|
71690382|NCT05464420|142897095|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.85|1.05|||||V116 Lot 1/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.85|
71690383|NCT05464420|142897095|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.87|1.08|||||V116 Lot 2/V116 Lot 3|Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.08|0.87|
71690384|NCT05464420|142897095|OTHER||GMC Ratio|1.12|||||TWO_SIDED|95.0|0.95|1.32|||||V116 Lot 1/V116 Lot 2|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.32|0.95|
71690385|NCT05464420|142897095|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.86|
71931533|NCT01032330|143384217|OTHER|||||||0.33|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.33
71931534|NCT01032330|143384218|OTHER|||||||0.013|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.013
71931535|NCT01032330|143384218|OTHER|||||||0.26|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.26
71931536|NCT01032330|143384219|OTHER|||||||0.42|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.42
71931537|NCT01032330|143384219|OTHER|||||||0.61|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.61
71931538|NCT01032330|143384220|OTHER|||||||0.012|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.012
71690386|NCT05464420|142897095|OTHER||GMC Ratio|0.91|||||TWO_SIDED|95.0|0.77|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.77|
71690387|NCT05464420|142897095|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
71690388|NCT05464420|142897095|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.9|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.90|
71690389|NCT05464420|142897095|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.93|1.21|||||V116 Lot 2/V116 Lot 3|Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.93|
71690390|NCT05464420|142897095|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.86|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.86|
71931539|NCT01032330|143384220|OTHER|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.02
71931540|NCT01032330|143384221|OTHER|||||||0.002|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||.002
71931541|NCT01032330|143384221|OTHER|||||||0.01|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.01
71931542|NCT01032330|143384222|OTHER|||||||0.11|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.11
71931543|NCT01032330|143384222|OTHER|||||||0.1|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.10
71931544|NCT01032330|143384223|OTHER|||||||0.6|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.60
71931545|NCT01032330|143384223|OTHER|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.||||0.09
71931546|NCT01155284|143384224|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED|||||The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.|ANCOVA|||||||0.81
71931547|NCT01155284|143384225|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||ANCOVA|||||||0.869
71931548|NCT02268045|143384226|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|Percentage difference|0.7|||||ONE_SIDED|95.0|-13.0||||||For the ITT population||||-13|
71931549|NCT02268045|143384226|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|percentage difference|3.0|||||ONE_SIDED|95.0|-13.0||||||For the PP population||||-13|
71931550|NCT02268045|143384227|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.2|||||TWO_SIDED|90.0|93.6|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.6|
71931551|NCT02268045|143384228|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|103.0|||||TWO_SIDED|90.0|98.5|107.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||107|98.5|
71931552|NCT02268045|143384229|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|99.6|||||TWO_SIDED|90.0|93.9|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||105|93.9|
71931553|NCT02268045|143384230|EQUIVALENCE|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%-125%.|ratio RTXM83 to Mabthera|104.0|||||TWO_SIDED|90.0|99.5|109.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator|||109|99.5|
71931554|NCT02268045|143384234|OTHER|||||||0.457|||||||Log Rank|||||||0.4570
71931555|NCT01766310|143384235|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.68|STANDARD_DEVIATION|1.3||0.05|TWO_SIDED|95.0|-0.09|1.44|||t-test, 2 sided|||||1.44|-0.09|0.05
71931556|NCT01154673|143384239|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.056|TWO_SIDED|95.0|-0.006|0.4||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|Regression, Linear||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|||0.4|-.006|0.056
71931557|NCT01556490|143384241|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.4552|TWO_SIDED|95.0|0.89|1.31|||Log Rank|||||1.31|0.89|0.4552
71931558|NCT01556490|143384242|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.0626|TWO_SIDED|95.0|0.61|1.01|||Log Rank|||||1.01|0.61|0.0626
71931559|NCT01556490|143384243|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.0227|TWO_SIDED|95.0|0.59|0.96|||Log Rank|||||.96|.59|0.0227
71931560|NCT01556490|143384244|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0043|TWO_SIDED|95.0|0.52|0.89|||Log Rank|||||.89|.52|0.0043
71931561|NCT01556490|143384245|SUPERIORITY||Mean Difference (Final Values)|15.5||||0.0001|TWO_SIDED|95.0|8.6|22.3|||2 sided calculated using continuity|2 sided calculated using continuity adjusted Wald Approach||||22.3|8.6|0.0001
71931562|NCT02328404|143384247|SUPERIORITY_OR_OTHER|||||||0.001|||||||Chi-squared|Fisher Exact test was used||The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value\</= 0.05)||||0.001
71931563|NCT02328404|143384248|SUPERIORITY_OR_OTHER||||||<|0||||||A P-value \< 0.05 would be considered statistically significant.|t-test, 2 sided|||Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points||||<0.000
71931564|NCT02328404|143384249|SUPERIORITY_OR_OTHER|||||||0.67|TWO_SIDED||||||t-test, 2 sided|||||||0.67
71931565|NCT02328404|143384250|SUPERIORITY_OR_OTHER|||||||0.51|TWO_SIDED||||||t-test, 2 sided|||||||0.51
71690391|NCT05464420|142897095|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71690392|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.89|
71690393|NCT05464420|142897095|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
71931566|NCT02328404|143384251|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||t-test, 2 sided|||||||0.08
71931567|NCT02328404|143384252|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71931568|NCT02328404|143384253|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Chi-squared|||||||0.001
71931569|NCT02328404|143384254|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED||||||t-test, 2 sided|||||||0.89
71931570|NCT02328404|143384255|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
71931571|NCT02328404|143384256|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||t-test, 2 sided|||||||0.01
71931572|NCT02328404|143384257|SUPERIORITY_OR_OTHER|||||||0.35|TWO_SIDED||||||t-test, 2 sided|||||||0.35
71931573|NCT02328404|143384258|SUPERIORITY_OR_OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71931574|NCT02328404|143384259|SUPERIORITY_OR_OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71931575|NCT02328404|143384260|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.04
71931576|NCT02328404|143384261|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
71931577|NCT02618772|143384262|SUPERIORITY_OR_OTHER|||||||0.026|||||||t-test, 2 sided|||||||0.026
71931578|NCT02618772|143384263|SUPERIORITY_OR_OTHER|||||||0.036|||||||t-test, 2 sided|||||||0.036
71931579|NCT02618772|143384264|SUPERIORITY_OR_OTHER|||||||0.151||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.151
71931580|NCT02618772|143384264|SUPERIORITY_OR_OTHER|||||||0.02||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.020
71931581|NCT02618772|143384264|SUPERIORITY_OR_OTHER|||||||0.198||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.198
71931582|NCT02618772|143384264|SUPERIORITY_OR_OTHER|||||||0.006||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.006
71931583|NCT02618772|143384265|SUPERIORITY_OR_OTHER|||||||0.185||||||This is in reference to the baseline measure.|t-test, 2 sided|||||||0.185
71931584|NCT02618772|143384265|SUPERIORITY_OR_OTHER|||||||0.011||||||This is in reference to the intervention measure.|t-test, 2 sided|||||||0.011
71931585|NCT02618772|143384265|SUPERIORITY_OR_OTHER|||||||0.191||||||This is in reference to the lidocaine measure.|t-test, 2 sided|||||||0.191
71931586|NCT02618772|143384265|SUPERIORITY_OR_OTHER|||||||0.008||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided|||||||0.008
71931587|NCT02618772|143384266|SUPERIORITY_OR_OTHER|||||||0.004||||||This p value is a t-test of the Post STAI minus Pre STAI variable.|t-test, 2 sided|||||||0.004
71931588|NCT02618772|143384267|SUPERIORITY_OR_OTHER|||||||0.015||||||This p value is in reference to the t-test performed for STAI Post Minus STAI Pre.|t-test, 2 sided|||||||0.015
71931589|NCT02618772|143384268|SUPERIORITY_OR_OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.080
71931590|NCT02618772|143384269|SUPERIORITY_OR_OTHER|||||||0.086|||||||t-test, 2 sided|||||||0.086
71690394|NCT05464420|142897095|OTHER||GMC Ratio|0.89|||||TWO_SIDED|95.0|0.77|1.03|||||V116 Lot 1/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.77|
71690395|NCT05464420|142897095|OTHER||GMC Ratio|0.85|||||TWO_SIDED|95.0|0.74|0.98|||||V116 Lot 2/V116 Lot 3|Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|0.98|0.74|
71690396|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
71690397|NCT05464420|142897095|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.83|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.83|
71690398|NCT05464420|142897095|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.82|1.11|||||V116 Lot 2/V116 Lot 3|Serotype 10A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.82|
71690399|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 1/V116 Lot 2|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
71690400|NCT05464420|142897095|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.91|
71690401|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.9|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.90|
71690402|NCT05464420|142897095|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.12|||||V116 Lot 1/V116 Lot 2|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.12|0.80|
71931591|NCT02618772|143384270|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71690403|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.18|||||V116 Lot 1/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.84|
71690404|NCT05464420|142897095|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.89|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 12F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.89|
71690405|NCT05464420|142897095|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
71690406|NCT05464420|142897095|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.83|1.11|||||V116 Lot 1/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.83|
71690407|NCT05464420|142897095|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.8|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 15A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.80|
71690408|NCT05464420|142897095|OTHER||GMC Ratio|1.06|||||TWO_SIDED|95.0|0.91|1.23|||||V116 Lot 1/V116 Lot 2|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.91|
71690409|NCT05464420|142897095|OTHER||GMC Ratio|1.03|||||TWO_SIDED|95.0|0.89|1.2|||||V116 Lot 1/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.20|0.89|
71931592|NCT02618772|143384271|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71931593|NCT04529499|143384279|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
71931594|NCT04529499|143384279|SUPERIORITY||Cox Proportional Hazard|0.991|||||TWO_SIDED|95.0|0.767|1.28|||||Favipiravir + supportive care in numerator and Placebo+ Supportive care in denominator for CPH ratio analysis|||1.280|0.767|
71690410|NCT05464420|142897095|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.14|||||V116 Lot 2/V116 Lot 3|Serotype 15C: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.84|
71690411|NCT05464420|142897095|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.03|||||V116 Lot 1/V116 Lot 2|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.03|0.78|
71690412|NCT05464420|142897095|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.78|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.78|
71690413|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 16F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
71690414|NCT05464420|142897095|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.91|1.21|||||V116 Lot 1/V116 Lot 2|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|0.91|
71690415|NCT05464420|142897095|OTHER||GMC Ratio|1.07|||||TWO_SIDED|95.0|0.93|1.23|||||V116 Lot 1/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.23|0.93|
71690416|NCT05464420|142897095|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.88|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 17F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.88|
71690417|NCT05464420|142897095|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.11|||||V116 Lot 1/V116 Lot 2|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.11|0.85|
71690418|NCT05464420|142897095|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.79|1.04|||||V116 Lot 1/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.04|0.79|
71690419|NCT05464420|142897095|OTHER||GMC Ratio|0.93|||||TWO_SIDED|95.0|0.82|1.07|||||V116 Lot 2/V116 Lot 3|Serotype 19A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.82|
71690420|NCT05464420|142897095|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.83|1.1|||||V116 Lot 1/V116 Lot 2|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.83|
71690421|NCT05464420|142897095|OTHER||GMC Ratio|0.96|||||TWO_SIDED|95.0|0.84|1.1|||||V116 Lot 1/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.84|
71931595|NCT04529499|143384280|SUPERIORITY|||||||0.34|||||||Fisher Exact|||||||0.34
71931596|NCT02524665|143384330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.67|STANDARD_DEVIATION|61.97||0.0769||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used|Wilcoxon signed-rank test||Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.0769
71931597|NCT02524665|143384330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.77|STANDARD_DEVIATION|33.73||0.6698||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6698
71931598|NCT02524665|143384330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.66|STANDARD_DEVIATION|17.59||0.6854||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.|||||0.6854
71931599|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|74.55||0.5031||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.5031
71931600|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.11|STANDARD_DEVIATION|99.76||0.2464||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.2464
71931601|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.03|STANDARD_DEVIATION|65.22||0.8894||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.8894
71931602|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.98|STANDARD_ERROR_OF_MEAN|46.04||0.6722||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.6722
71931603|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_DEVIATION|39.59||0.3352||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.3352
71931604|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|STANDARD_DEVIATION|35.46||0.9323||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9323
71931605|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.72|STANDARD_DEVIATION|26.05||0.3513||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.|||||0.3513
71931606|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22|STANDARD_DEVIATION|22.97||0.8199||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.|||||0.8199
71931607|NCT02524665|143384331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_DEVIATION|17.83||0.9616||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.|||||0.9616
71931608|NCT02524665|143384332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 1|||||1.0000
71931609|NCT02524665|143384332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.66||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.|||||0.7500
71931610|NCT02524665|143384332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||0.7539||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.|||||0.7539
71931611|NCT02524665|143384332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.87||0.3071||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 8|||||0.3071
71931612|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.|||||0.5000
71931613|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.52||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.|||||1.0000
71931614|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.|||||1.0000
71931615|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.|||||0
71931616|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.74||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||1.0000
71931617|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0
71931618|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0
71931619|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71931620|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.|||||1.0000
71931621|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.|||||0
71931622|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.|||||0
71931623|NCT02524665|143384333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71931624|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_DEVIATION|0.63||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 1.|||||0.5000
71931625|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 2.|||||0.5000
71931626|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.92||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 4.|||||1.0000
71931627|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16|STANDARD_DEVIATION|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71931628|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.88||0.8125||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.|||||0.8125
71931629|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_DEVIATION|0.94||0.5742||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.|||||0.5742
71931630|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.|||||0.5000
71931631|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.|||||0.2500
71931632|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.62||1||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 1.|||||1.0000
71931633|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 2.|||||0.7500
71931634|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.98||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 4.|||||0.7500
71931635|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.73||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 8.|||||0.2500
71931636|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.54||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 1.|||||0.2500
71931637|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 2.|||||0.7500
71931638|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|1.01||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 4.|||||0.2500
71931639|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32|STANDARD_DEVIATION|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 8.|||||0.2500
71931640|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_DEVIATION|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.|||||0.5000
71931641|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.|||||0
71931642|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26|STANDARD_DEVIATION|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.|||||0.5000
71931643|NCT02524665|143384334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11|STANDARD_DEVIATION|0.81||1||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.|||||1.0000
71931644|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||1.0000
71931645|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||0||95.0||||The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar|||||||0
71931646|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||0.5637
71931647|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar|||||||1.0000
71931648|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||0.4795||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||0.4795
71931649|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||1||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar|||||||1.0000
71931650|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||0.3173||95.0||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.3173
71931651|NCT02524665|143384335|SUPERIORITY_OR_OTHER|||||||0.1573||95.0||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar|||||||0.1573
71931652|NCT02200614|143384381|SUPERIORITY||Hazard Ratio (HR)|0.413|||<|1e-06|TWO_SIDED|95.0|0.341|0.5|||Log Rank||Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.500|0.341|<0.000001
71931653|NCT02200614|143384382|SUPERIORITY||Hazard Ratio (HR)|0.706||||0.04521|TWO_SIDED|95.0|0.501|0.994|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.994|0.501|0.045210
71931654|NCT02200614|143384383|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
71931655|NCT02200614|143384384|SUPERIORITY||Hazard Ratio (HR)|0.433|||<|1e-06|TWO_SIDED|95.0|0.314|0.595|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.595|0.314|<0.000001
71931656|NCT02200614|143384385|SUPERIORITY||Hazard Ratio (HR)|0.428||||0.011262|TWO_SIDED|95.0|0.218|0.842|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.842|0.218|0.011262
71931657|NCT02200614|143384386|SUPERIORITY||Hazard Ratio (HR)|0.685||||0.003048|TWO_SIDED|95.0|0.533|0.881|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.881|0.533|0.003048
71931658|NCT02200614|143384387|SUPERIORITY||Hazard Ratio (HR)|0.647||||8e-06|TWO_SIDED|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.785|0.533|0.000008
71931659|NCT02200614|143384388|SUPERIORITY||Hazard Ratio (HR)|0.579||||4.4e-05|TWO_SIDED|95.0|0.444|0.755|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.755|0.444|0.000044
71931660|NCT02200614|143384389|SUPERIORITY||Hazard Ratio (HR)|0.484||||0.005294|TWO_SIDED|95.0|0.287|0.815|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. \> 6 months) and use of osteoclast-targeted therapy (No, Yes).|||0.815|0.287|0.005294
71931661|NCT00759759|143384421|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|90.46||||||90.0|82.9|98.7|||ANOVA|||ANOVA of ln-transformed plasma morphine Cmax||98.7|82.9|
71931662|NCT00759759|143384423|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA performed on the ratio of geometric means|mean ratio|101.1||||||90.0|96.9|105.4|||ANOVA|||Statistical analysis of ln-transformed plasma morphine AUClast||105.4|96.9|
71931663|NCT00759759|143384424|NON_INFERIORITY_OR_EQUIVALENCE|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.3||||||90.0|96.2|106.7|||ANOVA|||||106.7|96.2|
71931664|NCT00301873|143384436|SUPERIORITY_OR_OTHER||Slope|-0.107|STANDARD_ERROR_OF_MEAN|0.0855||0.2212||95.0||||The p-value is a test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.||||.2212
71931665|NCT00301873|143384436|SUPERIORITY_OR_OTHER||Slope|0.2357|STANDARD_ERROR_OF_MEAN|0.1091||0.0413||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression||||.0413
71931666|NCT00301873|143384436|SUPERIORITY_OR_OTHER||Slope|-0.232|STANDARD_ERROR_OF_MEAN|0.1029||0.0418||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression||||.0418
71931667|NCT00301873|143384436|SUPERIORITY_OR_OTHER||Slope|0.2123|STANDARD_ERROR_OF_MEAN|0.1209||0.1026||95.0||||the p-value is a test of whether the slope ofl the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression||||.1026
71931668|NCT00391092|143384442|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.0775|TWO_SIDED|95.0|0.65|1.02|||Log Rank (unstratified)|||||1.02|0.65|0.0775
71931669|NCT00391092|143384443|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.9543|TWO_SIDED|95.0|0.74|1.38|||Log Rank|||||1.38|0.74|0.9543
71931670|NCT00391092|143384444|SUPERIORITY_OR_OTHER||Difference in Response rates|4.43||||0.3492|TWO_SIDED|95.0|-5.2|14.0|||Chi-squared||95% CI for the difference in response rates using Hauck-Anderson method.|||14.0|-5.2|0.3492
71931671|NCT00391092|143384445|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.56|0.98||||||||0.98|0.56|
71931672|NCT00391092|143384446|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.5392|TWO_SIDED|95.0|0.76|1.15|||Log Rank|||||1.15|0.76|0.5392
71931673|NCT02437890|143384467|SUPERIORITY||||||=|0.526||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: linear model"||||= 0.526
71931674|NCT02437890|143384467|SUPERIORITY||||||=|0.504||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: Emax model"||||= 0.504
71931675|NCT02437890|143384467|SUPERIORITY||||||=|0.548||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: logistic model"||||= 0.548
71931676|NCT02437890|143384467|SUPERIORITY||||||=|0.985||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 1st Beta model"||||= 0.985
71931677|NCT02437890|143384467|SUPERIORITY||||||=|0.524||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 2nd Beta model"||||= 0.524
71690422|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.88|1.16|||||V116 Lot 2/V116 Lot 3|Serotype 20A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.88|
71931678|NCT02414854|143384508|SUPERIORITY|Hierarchical testing procedure was used to control type I error rate at 0.05 level. The procedure included the 2 primary outcome measures and the first 13 secondary outcome measures reported and considered 2 pair-wise comparisons: Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w and Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w. Testing order is specified in analysis description.|Relative risk|0.54|||<|0.0001|TWO_SIDED|95.0|0.43|0.68||Hierarchical testing sequence performed continued only when previous outcome measures was statistically significant at 0.05. Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.||0.68|0.43|<0.0001
71931679|NCT02414854|143384508|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.523|||<|0.0001|TWO_SIDED|95.0|0.413|0.662||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.||0.662|0.413|<0.0001
71690423|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
71690424|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.87|1.16|||||V116 Lot 1/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.87|
71690425|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.86|1.15|||||V116 Lot 2/V116 Lot 3|Serotype 22F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.86|
71690426|NCT05464420|142897095|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.84|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.84|
71690427|NCT05464420|142897095|OTHER||GMC Ratio|0.98|||||TWO_SIDED|95.0|0.83|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.83|
71690428|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.85|1.17|||||V116 Lot 2/V116 Lot 3|Serotype 23A: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.85|
71690429|NCT05464420|142897095|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.87|1.18|||||V116 Lot 1/V116 Lot 2|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.18|0.87|
71690430|NCT05464420|142897095|OTHER||GMC Ratio|0.92|||||TWO_SIDED|95.0|0.79|1.07|||||V116 Lot 1/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.07|0.79|
71690431|NCT05464420|142897095|OTHER||GMC Ratio|0.9|||||TWO_SIDED|95.0|0.77|1.05|||||V116 Lot 2/V116 Lot 3|Serotype 23B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.05|0.77|
71690432|NCT05464420|142897095|OTHER||GMC Ratio|0.95|||||TWO_SIDED|95.0|0.8|1.13|||||V116 Lot 1/V116 Lot 2|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.80|
71690433|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.84|1.19|||||V116 Lot 1/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.19|0.84|
71690434|NCT05464420|142897095|OTHER||GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.25|||||V116 Lot 2/V116 Lot 3|Serotype 24F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.25|0.88|
71690435|NCT05464420|142897095|OTHER||GMC Ratio|0.88|||||TWO_SIDED|95.0|0.77|1.0|||||V116 Lot 1/V116 Lot 2|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.00|0.77|
71690436|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.14|||||V116 Lot 1/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.88|
71931680|NCT02414854|143384509|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Least Square (LS) Mean Difference|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.18||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.||0.18|0.08|<0.0001
71690437|NCT05464420|142897095|OTHER||GMC Ratio|1.14|||||TWO_SIDED|95.0|1.0|1.3|||||V116 Lot 2/V116 Lot 3|Serotype 31: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.30|1.00|
71690438|NCT05464420|142897095|OTHER||GMC Ratio|1.01|||||TWO_SIDED|95.0|0.89|1.16|||||V116 Lot 1/V116 Lot 2|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 2|GMC Ratio and 95% CI were estimated from a cLDA model.|1.16|0.89|
71690439|NCT05464420|142897095|OTHER||GMC Ratio|1.0|||||TWO_SIDED|95.0|0.88|1.15|||||V116 Lot 1/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.15|0.88|
71690440|NCT05464420|142897095|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 2/V116 Lot 3|Serotype 33F: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71690441|NCT05464420|142897095|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.9|1.17|||||V116 Lot 1/V116 Lot 2|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.17|0.90|
71690442|NCT05464420|142897095|OTHER||GMC Ratio|0.99|||||TWO_SIDED|95.0|0.87|1.13|||||V116 Lot 1/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 1/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.13|0.87|
71690443|NCT05464420|142897095|OTHER||GMC Ratio|0.97|||||TWO_SIDED|95.0|0.85|1.1|||||V116 Lot 2/V116 Lot 3|Serotype 35B: GMC Ratio V116 Lot 2/ V116 Lot 3|GMC Ratio and 95% CI were estimated from a cLDA model.|1.10|0.85|
71690444|NCT05464420|142897096|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|1.01|1.21|||||V116 Combined Lots/PPSV23|Serotype 3: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.21|1.01|
71690445|NCT05464420|142897096|OTHER||GMC Ratio|3.91|||||TWO_SIDED|95.0|3.43|4.45|||||V116 Combined Lots/PPSV23|Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|4.45|3.43|
71690446|NCT05464420|142897096|OTHER||GMC Ratio|1.54|||||TWO_SIDED|95.0|1.38|1.72|||||V116 Combined Lots/PPSV23|Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.72|1.38|
71690447|NCT05464420|142897096|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.89|||||V116 Combined Lots/PPSV23|Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.89|0.73|
71690448|NCT05464420|142897096|OTHER||GMC Ratio|1.02|||||TWO_SIDED|95.0|0.91|1.14|||||V116 Combined Lots/PPSV23|Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.14|0.91|
71690449|NCT05464420|142897096|OTHER||GMC Ratio|1.47|||||TWO_SIDED|95.0|1.3|1.66|||||V116 Combined Lots/PPSV23|Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.66|1.30|
71690450|NCT05464420|142897096|OTHER||GMC Ratio|1.38|||||TWO_SIDED|95.0|1.26|1.52|||||V116 Combined Lots/PPSV23|Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.52|1.26|
71690451|NCT05464420|142897096|OTHER||GMC Ratio|1.41|||||TWO_SIDED|95.0|1.23|1.62|||||V116 Combined Lots/PPSV23|Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.62|1.23|
71690452|NCT05464420|142897096|OTHER||GMC Ratio|6.82|||||TWO_SIDED|95.0|6.08|7.65|||||V116 Combined Lots/PPSV23|Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.65|6.08|
71690453|NCT05464420|142897096|OTHER||GMC Ratio|3.24|||||TWO_SIDED|95.0|2.86|3.67|||||V116 Combined Lots/PPSV23|Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|3.67|2.86|
71690454|NCT05464420|142897096|OTHER||GMC Ratio|6.48|||||TWO_SIDED|95.0|5.83|7.19|||||V116 Combined Lots/PPSV23|Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.19|5.83|
71931681|NCT02414854|143384509|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.14|||<|0.0001|TWO_SIDED|95.0|0.08|0.19||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.||0.19|0.08|<0.0001
71931682|NCT02414854|143384510|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|9.41|||<|0.0001|TWO_SIDED|95.0|5.74|13.07||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; \& treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value \& baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error \& handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.||13.07|5.74|<0.0001
71931683|NCT02414854|143384511|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.402|||<|0.0001|TWO_SIDED|95.0|0.307|0.526||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.||0.526|0.307|<0.0001
71931684|NCT02414854|143384512|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.21||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.||0.21|0.09|<0.0001
71931685|NCT02414854|143384513|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.326|||<|0.0001|TWO_SIDED|95.0|0.234|0.454||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.||0.454|0.234|<0.0001
71931686|NCT02414854|143384514|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.24|||<|0.0001|TWO_SIDED|95.0|0.16|0.32||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.||0.32|0.16|<0.0001
71931687|NCT02414854|143384515|SUPERIORITY|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.834||||0.2599|TWO_SIDED|95.0|0.608|1.144||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.||1.144|0.608|0.2599
71931688|NCT01160198|143384564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 once-daily||||<0.0001
71931689|NCT01160198|143384564|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 twice-daily||||<0.0001
71931690|NCT01160198|143384566|SUPERIORITY_OR_OTHER|||||||0.788|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily||||0.788
71931691|NCT01160198|143384566|SUPERIORITY_OR_OTHER|||||||0.911|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.911
71931692|NCT01160198|143384566|SUPERIORITY_OR_OTHER|||||||0.7|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily||||0.700
71931693|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.17|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 2||0.17|-0.29|1
71690455|NCT05464420|142897096|OTHER||GMC Ratio|1.85|||||TWO_SIDED|95.0|1.66|2.07|||||V116 Combined Lots/PPSV23|Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|2.07|1.66|
71690456|NCT05464420|142897096|OTHER||GMC Ratio|1.1|||||TWO_SIDED|95.0|0.98|1.22|||||V116 Combined Lots/PPSV23|Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.22|0.98|
71931694|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1||95.0|-0.57|0.31|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 4||0.31|-0.57|1
71931695|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.75|0.46|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 6||0.46|-0.75|1
71931696|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||1|TWO_SIDED|95.0|-1.05|0.53|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 8||0.53|-1.05|1
71931697|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.49|TWO_SIDED|95.0|-0.35|0.09|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.09|-0.35|0.490
71931698|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||1|TWO_SIDED|95.0|-0.58|0.29|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.29|-0.58|1
71931699|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.68|0.51|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.51|-0.68|1
71931700|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.84|0.72|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.72|-0.84|1
71931701|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||1|TWO_SIDED|95.0|-0.29|0.15|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2||0.15|-0.29|1
71931702|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.45|0.42|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4||0.42|-0.45|1
71931703|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||1|TWO_SIDED|95.0|-0.53|0.65|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6||0.65|-0.53|1
71931704|NCT01160198|143384567|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||1|TWO_SIDED|95.0|-0.58|0.98|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8||0.98|-0.58|1
71931705|NCT02016755|143384576|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||Overall (LOCF)||||0.331
71931706|NCT02016755|143384576|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||Activity (LOCF)||||0.362
71931707|NCT02016755|143384576|SUPERIORITY|||||||0.159|||||||t-test, 2 sided|||Emotional (LOCF)||||0.159
71931708|NCT02016755|143384576|SUPERIORITY|||||||0.468|||||||t-test, 2 sided|||Pain (LOCF)||||0.468
71931709|NCT02016755|143384576|SUPERIORITY|||||||0.197|||||||t-test, 2 sided|||Social (LOCF)||||0.197
71931710|NCT02016755|143384576|SUPERIORITY|||||||0.448|||||||t-test, 2 sided|||Symptom (LOCF)||||0.448
71931711|NCT02016755|143384577|SUPERIORITY|||||||0.939|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.939
71931712|NCT02016755|143384577|SUPERIORITY|||||||0.508|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.508
71931713|NCT02016755|143384577|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.474
71931714|NCT02016755|143384577|SUPERIORITY|||||||0.361|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.361
71931715|NCT02016755|143384577|SUPERIORITY|||||||0.258|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.258
71931716|NCT02016755|143384577|SUPERIORITY|||||||0.059|||||||t-test, 2 sided|||Change from baseline at Month 18||||0.059
71931717|NCT02016755|143384577|SUPERIORITY|||||||0.023|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.023
71931718|NCT02016755|143384578|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3 (Dorsalis pedis)||||0.655
71931719|NCT02016755|143384578|SUPERIORITY|||||||0.31|||||||t-test, 2 sided|||Change from Baseline at Month 6 (Dorsalis pedis)||||0.310
71931720|NCT02016755|143384578|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||Change from Baseline at Month 9 (Dorsalis pedis)||||0.348
71931721|NCT02016755|143384578|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||Change from Baseline at Month 12 (Dorsalis pedis)||||0.501
71931722|NCT02016755|143384578|SUPERIORITY|||||||0.536|||||||t-test, 2 sided|||Change from Baseline at Month 15 (Dorsalis pedis)||||0.536
71931723|NCT02016755|143384578|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change from Baseline at Month 18 (Dorsalis pedis)||||0.140
71931724|NCT02016755|143384578|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||Change from Baseline at LOCF (Dorsalis pedis)||||0.018
71931725|NCT02016755|143384578|SUPERIORITY|||||||0.716|||||||t-test, 2 sided|||Change from baseline at Month 3 (Posterior tibial)||||0.716
71931726|NCT02016755|143384578|SUPERIORITY|||||||0.641|||||||t-test, 2 sided|||Change from baseline at Month 6 (Posterior tibial)||||0.641
71931727|NCT02016755|143384578|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from baseline at Month 9 (Posterior tibial)||||0.514
71931728|NCT02016755|143384578|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||Change from baseline at Month 12 (Posterior tibial)||||0.808
71931729|NCT02016755|143384578|SUPERIORITY|||||||0.396|||||||t-test, 2 sided|||Change from baseline at Month 15 (Posterior tibial)||||0.396
71931730|NCT02016755|143384578|SUPERIORITY|||||||0.162|||||||t-test, 2 sided|||Change from baseline at Month 18 (Posterior tibial)||||0.162
71931731|NCT02016755|143384578|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||Change from baseline at LOCF (Posterior tibial)||||0.259
71931732|NCT02016755|143384579|SUPERIORITY|||||||0.671|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.671
71931733|NCT02016755|143384579|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.925
71931734|NCT02016755|143384579|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.514
71931735|NCT02016755|143384579|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.302
71931736|NCT02016755|143384579|SUPERIORITY|||||||0.373|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.373
71931737|NCT02016755|143384579|SUPERIORITY|||||||0.505|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.505
71931738|NCT02016755|143384579|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.135
71931739|NCT02016755|143384579|SUPERIORITY|||||||0.175|||||||t-test, 2 sided|||Change from baseline at month 3 (Left)||||0.175
71931740|NCT02016755|143384579|SUPERIORITY|||||||0.393|||||||t-test, 2 sided|||Change from baseline at month 6 (Left)||||0.393
71931741|NCT02016755|143384579|SUPERIORITY|||||||0.928|||||||t-test, 2 sided|||Change from baseline at month 9 (Left)||||0.928
71931742|NCT02016755|143384579|SUPERIORITY|||||||0.429|||||||t-test, 2 sided|||Change from baseline at month 12 (Left)||||0.429
71931743|NCT02016755|143384579|SUPERIORITY|||||||0.907|||||||t-test, 2 sided|||Change from baseline at month 15 (Left)||||0.907
71931744|NCT02016755|143384579|SUPERIORITY|||||||0.3|||||||t-test, 2 sided|||Change from baseline at month 18 (Left)||||0.300
71931745|NCT02016755|143384579|SUPERIORITY|||||||0.214|||||||t-test, 2 sided|||Change from baseline at LOCF (Left)||||0.214
71931746|NCT02016755|143384580|SUPERIORITY|||||||0.655|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.655
71931747|NCT02016755|143384580|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.226
71931748|NCT02016755|143384580|SUPERIORITY|||||||0.38|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.380
71931749|NCT02016755|143384580|SUPERIORITY|||||||0.187|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.187
71931750|NCT02016755|143384580|SUPERIORITY|||||||0.203|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.203
71931751|NCT02016755|143384580|SUPERIORITY|||||||0.074|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.074
71931752|NCT02016755|143384580|SUPERIORITY|||||||0.038|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.038
71931753|NCT02016755|143384581|SUPERIORITY|||||||0.246|||||||t-test, 2 sided|||Change from Baseline at Month 3||||0.246
71931754|NCT02016755|143384581|SUPERIORITY|||||||0.474|||||||t-test, 2 sided|||Change from Baseline at Month 6||||0.474
71931755|NCT02016755|143384581|SUPERIORITY|||||||0.395|||||||t-test, 2 sided|||Change from Baseline at Month 9||||0.395
71931756|NCT02016755|143384581|SUPERIORITY|||||||0.22|||||||t-test, 2 sided|||Change from Baseline at Month 12||||0.220
71931757|NCT02016755|143384581|SUPERIORITY|||||||0.454|||||||t-test, 2 sided|||Change from Baseline at Month 15||||0.454
71931758|NCT02016755|143384581|SUPERIORITY|||||||0.167|||||||t-test, 2 sided|||Change from Baseline at Month 18||||0.167
71931759|NCT02016755|143384581|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||Change from Baseline at LOCF||||0.015
71931760|NCT00337129|143384602|SUPERIORITY_OR_OTHER||Response probability|0.05|||||TWO_SIDED|95.0|0.01|0.17|||two-stage binomial|||Null hypothesis: response probability \< 5%; alternative hypothesis: response probability \> 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.||0.17|0.01|
71931761|NCT00450177|143384628|OTHER|||||||0.03|||||||Chi-squared|||||||0.03
71931762|NCT02613416|143384634|OTHER|||||||0.026||||||The p value was calculated.|Blyth-Still Casella Confidence Interval|||The primary hypothesis for this early phase study was that at least 30% of women would experience a \>5% relative decrease in their breast density after 6 months of treatment with denosumab 120 mg subcutaneous dose once a month.||||0.026
71931763|NCT00763269|143384636|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71931764|NCT00763269|143384637|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71931765|NCT00763269|143384638|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71931766|NCT00763269|143384639|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANCOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71931767|NCT01398982|143384647|NON_INFERIORITY_OR_EQUIVALENCE|Based on our published prospective, nonrandomized study using TAP block in abdominally-based autologous tissue breast reconstruction, 40 patients per group would achieve 85% power to detect a 65% reduction in mean total opioid consumption between the control and study groups (significance level alpha = 0.05; using a two-sided Wilcoxon rank-sum test).||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.02
71931768|NCT03964220|143384662|OTHER||Hazard Ratio (HR)|0.65||||0.044|TWO_SIDED|95.0|0.427|0.99|||Regression, Cox|||The time to first exacerbation was analysis using Cox Proportional Hazards model with group status as the only independent variable assessing the risk of exacerbation across Tio and NonTio groups.||0.990|0.427|0.044
71931769|NCT03964220|143384663|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 6 months of follow-up.||||< 0.0001
71931770|NCT03964220|143384663|OTHER||||||<|0.0001|||||||Negative binomial regression|||Analysis for the rate of exacerbation between Tio and NonTio groups within 1 year of follow-up.||||< 0.0001
71931771|NCT00589693|143384686|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%|Difference of 2 binomial proportions|-11.2|||||TWO_SIDED|95.0|-26.3|3.8|||Normal approximation of 2 proportions|||Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin||3.8|-26.3|
71931772|NCT00589693|143384687|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-18.8|||||TWO_SIDED|95.0|-57.2|19.5|||Normal approximation of 2 proportions|||||19.5|-57.2|
71931773|NCT00589693|143384688|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|-5.6|||||TWO_SIDED|95.0|-23.0|11.7|||Normal approximation of 2 proportions|||||11.7|-23.0|
71931774|NCT00589693|143384689|SUPERIORITY_OR_OTHER|||||||0.14|||||||Fisher Exact|||||||0.14
71690457|NCT05464420|142897096|OTHER||GMC Ratio|1.53|||||TWO_SIDED|95.0|1.37|1.71|||||V116 Combined Lots/PPSV23|Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.71|1.37|
71690458|NCT05464420|142897096|OTHER||GMC Ratio|1.32|||||TWO_SIDED|95.0|1.17|1.49|||||V116 Combined Lots/PPSV23|Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|1.49|1.17|
71690459|NCT05464420|142897096|OTHER||GMC Ratio|8.14|||||TWO_SIDED|95.0|7.19|9.23|||||V116 Combined Lots/PPSV23|Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|9.23|7.19|
71690460|NCT05464420|142897096|OTHER||GMC Ratio|5.74|||||TWO_SIDED|95.0|5.08|6.48|||||V116 Combined Lots/PPSV23|Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|6.48|5.08|
71690461|NCT05464420|142897096|OTHER||GMC Ratio|14.47|||||TWO_SIDED|95.0|12.77|16.4|||||V116 Combined Lots/PPSV23|Serotype 24F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|16.40|12.77|
71690462|NCT05464420|142897096|OTHER||GMC Ratio|9.55|||||TWO_SIDED|95.0|8.61|10.59|||||V116 Combined Lots/PPSV23|Serotype 31: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|10.59|8.61|
71931775|NCT00589693|143384690|SUPERIORITY_OR_OTHER||Difference of 2 binomial proportions|6.7|||||TWO_SIDED|95.0|-5.0|18.5|||Normal approximation of 2 proportions|||||18.5|-5.0|
71931776|NCT02609178|143384691|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.003||||||Alpha value was set at 0.05.|ANOVA|||||||0.003
71931777|NCT02609178|143384691|NON_INFERIORITY_OR_EQUIVALENCE|stated above in statistical analysis 1||||||0.366||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.366
71690463|NCT05464420|142897096|OTHER||GMC Ratio|0.81|||||TWO_SIDED|95.0|0.73|0.91|||||V116 Combined Lots/PPSV23|Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|0.91|0.73|
71690464|NCT05464420|142897096|OTHER||GMC Ratio|7.06|||||TWO_SIDED|95.0|6.41|7.77|||||V116 Combined Lots/PPSV23|Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23|GMC Ratio and 95% CI were estimated from a cLDA model.|7.77|6.41|
71690465|NCT03131687|142897120|OTHER||Posterior Mean Difference|-1.0|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690466|NCT03131687|142897120|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690467|NCT03131687|142897120|OTHER||Posterior Mean Difference|-1.83|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690468|NCT03131687|142897120|OTHER||Posterior Mean Difference|-1.89|STANDARD_DEVIATION|0.17|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690469|NCT03131687|142897121|OTHER||Posterior Mean Difference|-0.89|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690470|NCT03131687|142897121|OTHER||Posterior Mean Difference|-1.49|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690471|NCT03131687|142897121|OTHER||Posterior Mean Difference|-1.62|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690472|NCT03131687|142897121|OTHER||Posterior Mean Difference|-1.67|STANDARD_DEVIATION|0.15|||TWO_SIDED||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.|||||
71690473|NCT03131687|142897122|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.2|-0.4|||Mixed Models Analysis|||||-0.4|-1.2|<0.001
71690474|NCT03131687|142897122|OTHER||Median Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.2|-1.3|||Mixed Models Analysis|||||-1.3|-2.2|<0.001
71690475|NCT03131687|142897122|OTHER||Median Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.5|-1.6|||Mixed Models Analysis|||||-1.6|-2.5|<0.001
71690476|NCT03131687|142897122|OTHER||Median Difference (Final Values)|-2.5|||<|0.001|TWO_SIDED|95.0|-2.9|-2.0|||Mixed Models Analysis|||||-2.0|-2.9|<0.001
71690477|NCT03131687|142897123|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
71931778|NCT02609178|143384691|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.002
71931779|NCT02609178|143384691|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.054||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.054
71931780|NCT02609178|143384692|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.006||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.006
71690478|NCT03131687|142897123|OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.0|-1.3|||Mixed Models Analysis|||||-1.3|-2.0|<0.001
71690479|NCT03131687|142897123|OTHER||Mean Difference (Final Values)|-1.9|||<|0.001|TWO_SIDED|95.0|-2.3|-1.5|||Mixed Models Analysis|||||-1.5|-2.3|<0.001
71690480|NCT03131687|142897123|OTHER||Mean Difference (Final Values)|-2.1|||<|0.001|TWO_SIDED|95.0|-2.4|-1.7|||Mixed Models Analysis|||||-1.7|-2.4|<0.001
71690481|NCT03131687|142897124|OTHER||Mean Difference (Final Values)|-0.5||||0.655|TWO_SIDED|95.0|-2.7|1.7|||Mixed Models Analysis|||||1.7|-2.7|0.655
71690482|NCT03131687|142897124|OTHER||Mean Difference (Final Values)|-4.4|||<|0.001|TWO_SIDED|95.0|-6.6|-2.3|||Mixed Models Analysis|||||-2.3|-6.6|<0.001
71690483|NCT03131687|142897124|OTHER||Mean Difference (Final Values)|-8.3|||<|0.001|TWO_SIDED|95.0|-10.5|-6.0|||Mixed Models Analysis|||||-6.0|-10.5|<0.001
71690484|NCT03131687|142897124|OTHER||Median Difference (Final Values)|-10.9|||<|0.001|TWO_SIDED|95.0|-13.3|-8.6|||Mixed Models Analysis|||||-8.6|-13.3|<0.001
71690485|NCT03131687|142897125|OTHER|||||||0.053|||||||Regression, Logistic|||||||0.053
71690486|NCT03131687|142897125|OTHER|||||||0.002|||||||Regression, Logistic|||||||0.002
71690487|NCT03131687|142897125|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690488|NCT03131687|142897125|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71931781|NCT02609178|143384692|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistic analysis 1.||||||0.739||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.739
71690489|NCT03131687|142897126|OTHER|||||||0.193|||||||Regression, Logistic|||||||0.193
71690490|NCT03131687|142897126|OTHER|||||||0.036|||||||Regression, Logistic|||||||0.036
71931782|NCT02609178|143384692|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.03||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.03
71931783|NCT02609178|143384692|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.009||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.009
71931784|NCT02609178|143384693|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.001||||||alpha value was set at 0.05|Kruskal-Wallis|||||||0.001
71931785|NCT02609178|143384693|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.579||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.579
71931786|NCT02609178|143384693|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.001||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.001
71931787|NCT02609178|143384693|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)|||||||0.002
71931788|NCT02609178|143384694|NON_INFERIORITY_OR_EQUIVALENCE|Using G\*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.007||||||alpha value was set at 0.05|ANOVA|||||||0.007
71931789|NCT02609178|143384694|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.308||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.308
71931790|NCT02609178|143384694|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.005||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.005
71931791|NCT02609178|143384694|NON_INFERIORITY_OR_EQUIVALENCE|Stated above in statistical analysis 1.||||||0.141||||||Alpha value was set at 0.05.|Tukey's multiple comparison test|||||||0.141
71931792|NCT01128153|143384695|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.099|<|0.0001|TWO_SIDED|95.0|-0.86|-0.47|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.47|-0.86|<0.0001
71931793|NCT01128153|143384696|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.74|STANDARD_ERROR_OF_MEAN|7.667||0.0301|TWO_SIDED|95.0|-31.85|-1.62|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-1.62|-31.85|0.0301
71931794|NCT01128153|143384697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|STANDARD_ERROR_OF_MEAN|0.426||0.0301|TWO_SIDED|95.0|-1.77|-0.09|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||-0.09|-1.77|0.0301
71931795|NCT01128153|143384698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|4.595||0.0868|TWO_SIDED|95.0|-16.96|1.15|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||1.15|-16.96|0.0868
71931796|NCT01128153|143384699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44|STANDARD_ERROR_OF_MEAN|0.255||0.0868|TWO_SIDED|95.0|-0.94|0.06|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)|||0.06|-0.94|0.0868
71931797|NCT01128153|143384700|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.006|||<|0.0001|TWO_SIDED|95.0|3.852|21.05|||ANCOVA||Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)|||21.05|3.852|<0.0001
71931798|NCT01682512|143384701|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of \[-0.5, 0.5\].|Adjusted mean difference|-0.4|||||TWO_SIDED|90.0|-0.83|-0.03||Model analyzed was: DAS28(ESR) change from Baseline at Week 24 = overall mean + treatment + DAS28(ESR) Baseline score + visit + visit by treatment interaction + baseline-by-visit interaction + random error.|Mixed Models Analysis|A restricted maximum likelihood (REML)-based Mixed-Effect Model Repeated Measure (MMRM) approach was used.|Adjusted mean difference was calculated as: BI 695500 - Rituxan®|||-0.03|-0.83|
71931799|NCT01682512|143384702|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.35|STANDARD_ERROR_OF_MEAN|107.7|||TWO_SIDED|90.0|90.5|115.76|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.||115.76|90.50|
71690491|NCT03131687|142897126|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
71690492|NCT03131687|142897126|OTHER|||||||0.003|||||||Regression, Logistic|||||||0.003
71690493|NCT03131687|142897127|OTHER|||||||0.03|||||||Regression, Logistic|||||||0.030
71690494|NCT03131687|142897127|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690495|NCT03131687|142897127|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690496|NCT03131687|142897127|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690497|NCT03131687|142897128|OTHER|||||||0.008|||||||Regression, Logistic|||||||0.008
71690498|NCT03131687|142897128|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690499|NCT03131687|142897128|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690500|NCT03131687|142897128|OTHER||||||<|0.001|||||||Regression, Logistic|||||||<0.001
71690501|NCT03131687|142897129|OTHER||Mean Difference (Final Values)|-22.4||||0.01|TWO_SIDED|95.0|-39.4|-5.3|||Mixed Models Analysis|||||-5.3|-39.4|0.010
71690502|NCT03131687|142897129|OTHER||Mean Difference (Final Values)|-56.2|||<|0.001|TWO_SIDED|95.0|-72.9|-39.5|||Mixed Models Analysis|||||-39.5|-72.9|<0.001
71931800|NCT01682512|143384702|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|88.21|STANDARD_ERROR_OF_MEAN|107.5|||TWO_SIDED|90.0|78.24|99.46|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.||99.46|78.24|
71931801|NCT01682512|143384702|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.18|STANDARD_ERROR_OF_MEAN|107.449|||TWO_SIDED|90.0|76.5|97.09|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.||97.09|76.50|
71931802|NCT01682512|143384703|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|102.46|STANDARD_ERROR_OF_MEAN|107.939|||TWO_SIDED|90.0|90.26|116.3|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.||116.30|90.26|
71931803|NCT01682512|143384703|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|86.0|STANDARD_ERROR_OF_MEAN|107.404|||TWO_SIDED|90.0|76.38|96.82|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.||96.82|76.38|
71931804|NCT01682512|143384703|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|83.93|STANDARD_ERROR_OF_MEAN|107.386|||TWO_SIDED|90.0|74.57|94.47|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.||94.47|74.57|
71931805|NCT01682512|143384704|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.87|STANDARD_ERROR_OF_MEAN|106.608|||TWO_SIDED|90.0|86.21|106.62|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.||106.62|86.21|
71931806|NCT01682512|143384704|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.46|STANDARD_ERROR_OF_MEAN|106.775|||TWO_SIDED|90.0|80.23|99.74|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.||99.74|80.23|
71931807|NCT01682512|143384704|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.31|STANDARD_ERROR_OF_MEAN|105.7|||TWO_SIDED|90.0|85.11|102.29|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.||102.29|85.11|
71931808|NCT01682512|143384705|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|93.97|STANDARD_ERROR_OF_MEAN|105.995|||TWO_SIDED|90.0|85.32|103.5|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.||103.50|85.32|
71931809|NCT01682512|143384705|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|89.3|STANDARD_ERROR_OF_MEAN|105.657|||TWO_SIDED|90.0|81.51|97.83|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.||97.83|81.51|
71931810|NCT01682512|143384705|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|95.02|STANDARD_ERROR_OF_MEAN|105.744|||TWO_SIDED|90.0|86.62|104.25|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.||104.25|86.62|
71931811|NCT01682512|143384707|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|104.49|STANDARD_ERROR_OF_MEAN|108.044|||TWO_SIDED|90.0|91.92|118.78|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.||118.78|91.92|
71931812|NCT01682512|143384707|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|91.39|STANDARD_ERROR_OF_MEAN|107.253|||TWO_SIDED|90.0|81.38|102.64|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.||102.64|81.38|
71931813|NCT01682512|143384707|SUPERIORITY_OR_OTHER||Adjusted ratio of gMeans (%)|87.47|STANDARD_ERROR_OF_MEAN|107.896|||TWO_SIDED|90.0|77.12|99.21|||ANOVA|Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error|Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.||99.21|77.12|
71931814|NCT00054275|143384708|SUPERIORITY_OR_OTHER||proportion of pts with partial response|0.39||||0.95|TWO_SIDED|95.0|0.23|0.58|||confidence interval for partial response|Confidence interval for partial response rate using Wilson's Method||||0.58|0.23|0.95
71931815|NCT02572427|143384714|SUPERIORITY_OR_OTHER_LEGACY|||||||0.039|TWO_SIDED||||||t-test, 2 sided|||||||0.039
71931816|NCT02572427|143384715|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71931817|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.39|TWO_SIDED|95.0|-4.29|1.68|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.68|-4.29|0.390
71931818|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.264|TWO_SIDED|95.0|-1.37|4.97|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.97|-1.37|0.264
71690503|NCT03131687|142897129|OTHER||Odds Ratio (OR)|-76.3|||<|0.001|TWO_SIDED|95.0|-93.3|-59.2|||Mixed Models Analysis|||||-59.2|-93.3|<0.001
71931819|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.357|TWO_SIDED|95.0|-4.74|1.72|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.72|-4.74|0.357
71931820|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.981|TWO_SIDED|95.0|-3.5|3.42|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.42|-3.50|0.981
71931821|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.584|TWO_SIDED|95.0|-4.37|2.47|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.47|-4.37|0.584
71931822|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.58||||0.392|TWO_SIDED|95.0|-2.05|5.2|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.20|-2.05|0.392
71931823|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.345|TWO_SIDED|95.0|-6.34|2.24|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.24|-6.34|0.345
71931824|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.922|TWO_SIDED|95.0|-4.73|4.28|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.28|-4.73|0.922
71931825|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44||||0.384|TWO_SIDED|95.0|-7.97|3.1|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.10|-7.97|0.384
71931826|NCT00996918|143384717|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.961|TWO_SIDED|95.0|-6.08|5.78|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.78|-6.08|0.961
71931827|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.22||||0.837|TWO_SIDED|95.0|-1.91|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-1.91|0.837
71931828|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.14||||0.064|TWO_SIDED|95.0|-0.13|4.41|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.41|-0.13|0.064
71931829|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.99|TWO_SIDED|95.0|-2.32|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.35|-2.32|0.990
71690504|NCT03131687|142897129|OTHER||Mean Difference (Final Values)|-73.0|||<|0.001|TWO_SIDED|95.0|-90.9|-55.2|||Mixed Models Analysis|||||-55.2|-90.9|<0.001
71690505|NCT03131687|142897130|OTHER||Mean Difference (Final Values)|0.0||||0.396|TWO_SIDED|95.0|-0.1|0.0|||Mixed Models Analysis|||||0.0|-0.1|0.396
71690506|NCT03131687|142897130|OTHER||Mean Difference (Final Values)|0.0||||0.903|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.903
71690507|NCT03131687|142897130|OTHER||Mean Difference (Final Values)|0.0||||0.536|TWO_SIDED|95.0|-0.1|0.1|||Mixed Models Analysis|||||0.1|-0.1|0.536
71690508|NCT03131687|142897130|OTHER||Mean Difference (Final Values)|0.0||||0.325|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||||0.1|-0.0|0.325
71690509|NCT03131687|142897131|OTHER||Mean Difference (Final Values)|-0.1||||0.565|TWO_SIDED|95.0|-0.4|0.2|||Mixed Models Analysis|||||0.2|-0.4|0.565
71690510|NCT03131687|142897131|OTHER||Mean Difference (Final Values)|-0.4||||0.01|TWO_SIDED|95.0|-0.7|-0.1|||Mixed Models Analysis|||||-0.1|-0.7|0.010
71690511|NCT03131687|142897131|OTHER||Median Difference (Final Values)|-0.5||||0.001|TWO_SIDED|95.0|-0.9|-0.2|||Mixed Models Analysis|||||-0.2|-0.9|0.001
71690512|NCT03131687|142897131|OTHER||Median Difference (Final Values)|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3|||Mixed Models Analysis|||||-0.3|-0.9|<0.001
71690513|NCT03131687|142897132|OTHER||Mean Difference (Final Values)|-0.3||||0.164|TWO_SIDED|95.0|-0.7|0.1|||Mixed Models Analysis|||||0.1|-0.7|0.164
71690514|NCT03131687|142897132|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.4|||Mixed Models Analysis|||||-0.4|-1.1|<0.001
71690515|NCT03131687|142897132|OTHER||Mean Difference (Final Values)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.4|-0.6|||Mixed Models Analysis|||||-0.6|-1.4|<0.001
71931830|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.817|TWO_SIDED|95.0|-2.22|2.82|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.82|-2.22|0.817
71690516|NCT03131687|142897132|OTHER||Median Difference (Final Values)|-1.1|||<|0.001|TWO_SIDED|95.0|-1.5|-0.7|||Mixed Models Analysis|||||-0.7|-1.5|<0.001
71690517|NCT03131687|142897133|OTHER||Mean Difference (Final Values)|0.0||||0.919|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.919
71690518|NCT03131687|142897133|OTHER||Mean Difference (Final Values)|-0.2||||0.194|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.194
71690519|NCT03131687|142897133|OTHER||Mean Difference (Final Values)|-0.2||||0.145|TWO_SIDED|95.0|-0.5|0.1|||Mixed Models Analysis|||||0.1|-0.5|0.145
71690520|NCT03131687|142897133|OTHER||Mean Difference (Final Values)|-0.3||||0.067|TWO_SIDED|95.0|-0.6|0.0|||Mixed Models Analysis|||||0.0|-0.6|0.067
71690521|NCT03131687|142897134|OTHER||Mean Difference (Final Values)|-0.7||||0.539|TWO_SIDED|95.0|-3.1|1.6|||Mixed Models Analysis|||||1.6|-3.1|0.539
71690522|NCT03131687|142897134|OTHER||Mean Difference (Final Values)|-3.8||||0.001|TWO_SIDED|95.0|-6.1|-1.5|||Mixed Models Analysis|||||-1.5|-6.1|0.001
71690523|NCT03131687|142897134|OTHER||Mean Difference (Final Values)|-6.0|||<|0.001|TWO_SIDED|95.0|-8.4|-3.7|||Mixed Models Analysis|||||-3.7|-8.4|<0.001
71690524|NCT03131687|142897134|OTHER||Mean Difference (Final Values)|-8.8|||<|0.001|TWO_SIDED|95.0|-11.3|-6.4|||Mixed Models Analysis|||||-6.4|-11.3|<0.001
71690525|NCT06597084|142897161|OTHER||Percentiles of time to first US|92.0||||0.2081|TWO_SIDED|95.0|25.0|95.0|||Log Rank|||||95|25|0.2081
71690526|NCT06597084|142897167|OTHER||Overall Survival|||||0.0542|||||||Log Rank|||||||0.0542
71690527|NCT01243177|142897188|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.5|2.8|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.8|-5.5|
71690528|NCT01243177|142897189|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The hypothesis was as follows:~H0: \[S(t)LCM\] - \[S(t)CBZ-CR\] ≤ -12 % versus HA: \[S(t)LCM\] - \[S(t)CBZ-CR\] \> -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-5.3|2.7|||Mantel Haenszel|The analysis was stratified based on the number of seizures in the 3 months preceding enrollment (≤ 2 and \>2).|The lower limit of the confidence interval was \>-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was \>- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.||2.7|-5.3|
71690529|NCT02781818|142897198|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||0.77
71690530|NCT02781818|142897198|SUPERIORITY|||||||0.46|||||||Mixed Models Analysis|||||||0.46
71690531|NCT02781818|142897199|SUPERIORITY|||||||0.65|||||||Mixed Models Analysis|||||||.65
71690532|NCT02781818|142897199|SUPERIORITY|||||||0.98|||||||Mixed Models Analysis|||||||0.98
71690533|NCT02781818|142897200|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.50
71690534|NCT02781818|142897200|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71690535|NCT00707057|142897211|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and \>7).||||<0.0001
71690536|NCT00707057|142897212|SUPERIORITY_OR_OTHER||||||<|0.0017||95.0|||||ANCOVA|||The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.||||<0.0017
71690537|NCT00707057|142897213|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
71931831|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.697|TWO_SIDED|95.0|-2.04|3.05|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-2.04|0.697
71690538|NCT00707057|142897214|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.||||<0.0001
71690539|NCT00707057|142897215|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71690540|NCT00707057|142897216|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.0001
71690541|NCT00707057|142897216|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel|||||||<0.0001
71690542|NCT00707057|142897217|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and \>7.||The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval. Time weighted TOTPAR for ech specified interval was similarly derived.||||<0.0001
71690543|NCT00707057|142897218|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Log Rank|||||||<0.0001
71690544|NCT00707057|142897219|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|||The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.||||<0.0001
71690545|NCT00707057|142897220|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.||||<0.0001
71690546|NCT00707057|142897221|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).||||<0.0001
71690547|NCT00707057|142897222|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief."||||<0.0001
71931832|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.93||||0.158|TWO_SIDED|95.0|-0.76|4.63|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.63|-0.76|0.158
71931833|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.829|TWO_SIDED|95.0|-4.06|3.26|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.26|-4.06|0.829
71931834|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.95|TWO_SIDED|95.0|-3.69|3.93|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|-3.69|0.950
71690548|NCT00707057|142897222|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.|ANCOVA|||"Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
71690549|NCT00707057|142897222|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."||||<0.0001
71690550|NCT00707057|142897223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
71690551|NCT00707057|142897223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and basee pain score categories.|ANCOVA|||Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71690552|NCT00707057|142897223|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71690553|NCT00707057|142897224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.||||<0.0001
71690554|NCT00707057|142897224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71690555|NCT00707057|142897224|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.||||<0.0001
71690556|NCT04611542|142897225|SUPERIORITY||Mean Difference (Final Values)|1.02|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<0.001
71690557|NCT04611542|142897226|SUPERIORITY||Median Difference (Final Values)|1.12|||<|0.001|TWO_SIDED||||||t-test, 2 sided|||||||<.001
71690558|NCT04611542|142897227|SUPERIORITY||Mean Difference (Final Values)|6.32|||<|0.001|TWO_SIDED||||||t-test, 2 sided||Investigators tested whether pretest to posttest change was significantly greater than 0 at P \< 0.05.|||||<0.001
71690559|NCT00320242|142897228|SUPERIORITY||Mean Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|0.48||0.0152|TWO_SIDED|95.0|0.26|2.23|||t-test, 2 sided|two-tailed paired t-test||||2.23|0.26|0.0152
71931835|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.816|TWO_SIDED|95.0|-5.35|4.23|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.23|-5.35|0.816
71690560|NCT00320242|142897229|SUPERIORITY||Mean Difference (Final Values)|50.0|STANDARD_ERROR_OF_MEAN|11.7||0.005|TWO_SIDED|95.0|23.9|76.1|||t-test, 2 sided|||||76.1|23.9|0.005
71690561|NCT00320242|142897230|SUPERIORITY||Mean Difference (Net)|1.11|STANDARD_DEVIATION|1.31||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|two-tailed Wilcoxan signed-rank sum test||two-tailed Wilcoxan signed-rank sum test||||0.02
71690562|NCT00320242|142897231|OTHER|The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||||0.002||||||Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.|t-test, 2 sided|||The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||0.002
71690563|NCT00472732|142897232|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in posterior cingulate gray matter will be the same in OTCD patients as in controls.||||0.003
71690564|NCT00472732|142897232|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in parietal white matter will be the same in OTCD patients as in controls.||||<0.001
71690565|NCT00472732|142897232|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in posterior cingulate gray matter would be the same for OTCD patients as for controls.||||0.001
71690566|NCT00472732|142897232|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in parietal white matter would be the same for OTCD patients as for controls.||||<0.001
71690567|NCT00472732|142897233|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||This p-value is adjusted for family wise error rate correction.|t-test, 2 sided|||Two-way between-group t-tests restricted to the prefrontal cortex were performed to compare activation during for the 2-Back\> 1-Back contrast between OTCD patients and controls.||||<0.05
71690568|NCT00472732|142897234|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||t-test, 2 sided|||The null hypothesis predicted that fractional anisotropy, a marker of white matter integrity, would be the same for OTCD patients as for controls.||||<0.001
71690569|NCT02915159|142897235|SUPERIORITY|||||||0.4421|||||||longitudinal repeated measures analysis|||||||0.4421
71690570|NCT02915159|142897236|SUPERIORITY|||||||0.3367|||||||longitudinal repeated measures analysis|||||||0.3367
71690571|NCT02915159|142897237|SUPERIORITY|||||||0.5841|||||||longitudinal repeated measures analysis|||||||.5841
71690572|NCT02821416|142897279|SUPERIORITY||Median Difference (Final Values)|-5.81||||0.0208|TWO_SIDED|95.0|-10.69|-0.94|||Mixed Models Analysis|Model includes covariates of treatment, time post-allergen challenge , treatment\*time post-allergen challenge, allergen induced at screening||||-0.94|-10.69|0.0208
71690573|NCT02821416|142897280|SUPERIORITY||Median Difference (Final Values)|2.535||||0.363|TWO_SIDED|95.0|-3.045|8.116|||Mixed Models Analysis|Model includes covariates of treatment, maximum percent decrease in FEV1 late asthma response||||8.116|-3.045|0.3630
71931836|NCT00996918|143384718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.82||||0.751|TWO_SIDED|95.0|-4.32|5.96|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.96|-4.32|0.751
71931837|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.967|TWO_SIDED|95.0|-7.22|7.53|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.53|-7.22|0.967
71931838|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13||||0.593|TWO_SIDED|95.0|-5.72|9.98|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.98|-5.72|0.593
71931839|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.968|TWO_SIDED|95.0|-7.32|7.62|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.62|-7.32|0.968
71931840|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.92||||0.473|TWO_SIDED|95.0|-10.92|5.08|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.08|-10.92|0.473
71931841|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.63|TWO_SIDED|95.0|-9.91|6.02|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.02|-9.91|0.630
71931842|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.53||||0.293|TWO_SIDED|95.0|-13.02|3.95|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-13.02|0.293
71931843|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.53||||0.733|TWO_SIDED|95.0|-7.28|10.33|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.33|-7.28|0.733
71931844|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.81||||0.55|TWO_SIDED|95.0|-12.06|6.45|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.45|-12.06|0.550
71931845|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.902|TWO_SIDED|95.0|-11.04|12.5|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||12.50|-11.04|0.902
71931846|NCT00996918|143384719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.07||||0.43|TWO_SIDED|95.0|-17.75|7.61|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||7.61|-17.75|0.430
71931847|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.683|TWO_SIDED|95.0|-6.01|3.95|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.95|-6.01|0.683
71931848|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.69||||0.177|TWO_SIDED|95.0|-1.68|9.06|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.06|-1.68|0.177
71931849|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.734|TWO_SIDED|95.0|-6.03|4.25|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.25|-6.03|0.734
71931850|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.595|TWO_SIDED|95.0|-7.06|4.05|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.05|-7.06|0.595
71931851|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.35||||0.409|TWO_SIDED|95.0|-7.95|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-7.95|0.409
71931852|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.368|TWO_SIDED|95.0|-8.73|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.24|-8.73|0.368
71931853|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.44||||0.458|TWO_SIDED|95.0|-4.01|8.89|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||8.89|-4.01|0.458
71931854|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04||||0.76|TWO_SIDED|95.0|-7.77|5.68|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.68|-7.77|0.760
71931855|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.597|TWO_SIDED|95.0|-5.67|9.86|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.86|-5.67|0.597
71931856|NCT00996918|143384720|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87||||0.501|TWO_SIDED|95.0|-11.24|5.5|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.50|-11.24|0.501
71931857|NCT00996918|143384721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.6||||0.183|TWO_SIDED|95.0|-8.91|1.71|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.71|-8.91|0.183
71931858|NCT00996918|143384721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.92|TWO_SIDED|95.0|-5.92|5.35|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||5.35|-5.92|0.920
71931859|NCT00996918|143384721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.99||||0.133|TWO_SIDED|95.0|-11.52|1.53|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.53|-11.52|0.133
71690574|NCT01065571|142897281|EQUIVALENCE|Non-parametric analysis of interval to relapse||||||0.046||||||result from log rank test|Log Rank|||Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.||||0.046
71931860|NCT00996918|143384721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.34||||0.505|TWO_SIDED|95.0|-4.55|9.22|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||9.22|-4.55|0.505
71931861|NCT00996918|143384721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.86||||0.003|TWO_SIDED|95.0|-21.46|-4.25|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||-4.25|-21.46|0.003
71931862|NCT00996918|143384721|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.47||||0.76|TWO_SIDED|95.0|-7.95|10.88|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||10.88|-7.95|0.760
71931863|NCT00996918|143384722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08||||0.373|TWO_SIDED|95.0|-6.68|2.52|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.52|-6.68|0.373
71931864|NCT00996918|143384722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.677|TWO_SIDED|95.0|-5.92|3.86|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.86|-5.92|0.677
71931865|NCT00996918|143384722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.28|TWO_SIDED|95.0|-9.61|2.8|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.80|-9.61|0.280
71931866|NCT00996918|143384722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.95|TWO_SIDED|95.0|-6.34|6.76|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||6.76|-6.34|0.950
71931867|NCT00996918|143384722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.06||||0.13|TWO_SIDED|95.0|-23.16|3.05|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.05|-23.16|0.130
71931868|NCT00996918|143384722|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.48||||0.732|TWO_SIDED|95.0|-11.97|16.94|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||16.94|-11.97|0.732
71931869|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.938|TWO_SIDED|95.0|-1.12|1.21|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.21|-1.12|0.938
71931870|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.753|TWO_SIDED|95.0|-1.43|1.04|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.04|-1.43|0.753
71931871|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.809|TWO_SIDED|95.0|-1.04|1.33|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.33|-1.04|0.809
71931872|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.421|TWO_SIDED|95.0|-1.8|0.75|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.75|-1.80|0.421
71931873|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.535|TWO_SIDED|95.0|-0.85|1.63|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.63|-0.85|0.535
71931874|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52||||0.445|TWO_SIDED|95.0|-0.82|1.86|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.86|-0.82|0.445
71931875|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.309|TWO_SIDED|95.0|-0.67|2.12|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.12|-0.67|0.309
71931876|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.872|TWO_SIDED|95.0|-1.34|1.57|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-1.34|0.872
71931877|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.004|TWO_SIDED|95.0|0.79|4.26|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.26|0.79|0.004
71931878|NCT00996918|143384723|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09||||0.026|TWO_SIDED|95.0|0.25|3.93|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.93|0.25|0.026
71931879|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.504|TWO_SIDED|95.0|-0.77|1.57|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.57|-0.77|0.504
71931880|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.592|TWO_SIDED|95.0|-1.58|0.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.90|-1.58|0.592
71931881|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.441|TWO_SIDED|95.0|-0.72|1.65|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.65|-0.72|0.441
71931882|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.288|TWO_SIDED|95.0|-1.97|0.59|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||0.59|-1.97|0.288
71931883|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66||||0.303|TWO_SIDED|95.0|-0.59|1.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.90|-0.59|0.303
71931884|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.713|TWO_SIDED|95.0|-1.09|1.6|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.60|-1.09|0.713
71931885|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.93||||0.198|TWO_SIDED|95.0|-0.49|2.34|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||2.34|-0.49|0.198
71931886|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.756|TWO_SIDED|95.0|-1.7|1.24|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||1.24|-1.70|0.756
71931887|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.45||||0.006|TWO_SIDED|95.0|0.69|4.22|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||4.22|0.69|0.006
71931888|NCT00996918|143384724|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.75||||0.066|TWO_SIDED|95.0|-0.12|3.62|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."||3.62|-0.12|0.066
71931889|NCT00854607|143384750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28||||0.166|TWO_SIDED|90.0|-0.2|0.77||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.77|-0.20|0.166
71931890|NCT00854607|143384751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.269|TWO_SIDED|90.0|-0.65|0.3||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.30|-0.65|0.269
71931891|NCT00854607|143384752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.101|TWO_SIDED|90.0|-0.06|0.44||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.44|-0.06|0.101
71931892|NCT00854607|143384753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.457|TWO_SIDED|90.0|-0.42|0.47||One-Sided P-Value|t-test, 1 sided|||Mean Difference Between Non-Responders and Responders||0.47|-0.42|0.457
71931893|NCT00854607|143384754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.168|TWO_SIDED|90.0|-0.87|0.23||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.23|-0.87|0.168
71931894|NCT00854607|143384755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.127|TWO_SIDED|90.0|-0.09|0.46||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.46|-0.09|0.127
71931895|NCT00854607|143384756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.47||||0.054|TWO_SIDED|90.0|-0.01|0.96||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.96|-0.01|0.054
71931896|NCT00854607|143384757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21||||0.285|TWO_SIDED|90.0|-0.41|0.83||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.83|-0.41|0.285
71931897|NCT00854607|143384758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.159|TWO_SIDED|90.0|-0.27|1.08||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.08|-0.27|0.159
71931898|NCT00854607|143384759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.071|TWO_SIDED|90.0|-0.02|0.32||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.02|0.071
71931899|NCT00854607|143384760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17||||0.078|TWO_SIDED|90.0|-0.03|0.38||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.38|-0.03|0.078
71931900|NCT00854607|143384761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39||||0.109|TWO_SIDED|90.0|-0.13|0.91||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.91|-0.13|0.109
71931901|NCT00854607|143384762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.65||||0.03|TWO_SIDED|90.0|0.09|1.22||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||1.22|0.09|0.030
71931902|NCT00854607|143384763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.293|TWO_SIDED|90.0|-0.63|0.32||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.32|-0.63|0.293
71931903|NCT00854607|143384764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.213|TWO_SIDED|90.0|-0.83|0.29||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders||0.29|-0.83|0.213
71931904|NCT00190684|143384769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for systolic BP|Wilcoxon signed-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931905|NCT00190684|143384769|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for diastolic BP|Wilcoxon sign-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931906|NCT00190684|143384770|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for pulse|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71690575|NCT01065571|142897282|SUPERIORITY|fecal calprotectin (micrograms/gm stool)||||||0.06|||||||t-test, 2 sided|||||||0.06
71931907|NCT00190684|143384771|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931908|NCT00190684|143384772|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931909|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931910|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931911|NCT00190684|143384773|SUPERIORITY_OR_OTHER|||||||0.644||95.0||||p-value is for weight 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.644
71931912|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for weight 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931913|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931914|NCT00190684|143384773|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for height 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.001
71931915|NCT00190684|143384773|SUPERIORITY_OR_OTHER|||||||0.044||95.0||||p-value is for height 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.044
71931916|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for height 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931917|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931918|NCT00190684|143384773|SUPERIORITY_OR_OTHER|||||||0.032||95.0||||p-value is for BMI 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.032
71690576|NCT01065571|142897283|SUPERIORITY|||||||0.02||||||not adjusted for muliple comparisons, a priori threshold of 0.05|t-test, 2 sided|||paired t-test comparing baseline and value at end of participation||||0.02
71931919|NCT00190684|143384773|SUPERIORITY_OR_OTHER|||||||0.351||95.0||||p-value is for BMI 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.351
71931920|NCT00190684|143384773|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for BMI 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931921|NCT00190684|143384774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for RR interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931922|NCT00190684|143384774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QRS Interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931923|NCT00190684|143384774|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for QT Bazett Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931924|NCT00190684|143384774|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for QT Data Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.310
71931925|NCT00190684|143384774|SUPERIORITY_OR_OTHER|||||||0.632||95.0||||p-value is for QT Fridericia Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.632
71931926|NCT00190684|143384775|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for HR.|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931927|NCT00190684|143384777|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Total Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
71931928|NCT00190684|143384777|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Inattentive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931929|NCT00190684|143384777|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for Hyperactive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
71931930|NCT00190684|143384778|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CGI ADHD Severity within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||||||<0.001
71931931|NCT00190684|143384779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS ADHD Index Subscale within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931932|NCT00190684|143384779|SUPERIORITY_OR_OTHER||||||p<|0||95.0||||p-value is for CPRS Cognitive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||p<0.001
71931933|NCT00190684|143384779|SUPERIORITY_OR_OTHER|||||||0.026||95.0||||p-value is for CPRS Hyperactive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||0.026
71931934|NCT00190684|143384779|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for CPRS Oppositional Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.||||<0.001
71931935|NCT01494649|143384814|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.1||||0.2294|TWO_SIDED|95.0|-0.26|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|The model included treatment as a fixed factor and basline Schiff score as a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favoured stannous fluoride toothpaste.|Null hypothesis is no difference between treatments. Tests were 2-sided.||0.06|-0.26|0.2294
71931936|NCT01494649|143384815|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.12||||0.1792||95.0|-0.3|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||0.06|-0.30|0.1792
71931937|NCT01494649|143384816|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.52|||<|0.0001|TWO_SIDED|95.0|-0.74|-0.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||-0.30|-0.74|<0.0001
71931938|NCT01494649|143384817|SUPERIORITY_OR_OTHER||Mean adjusted difference|-0.08||||0.9445|TWO_SIDED|95.0|-2.49|2.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Tactile Threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2.32|-2.49|0.9445
71931939|NCT01494649|143384818|SUPERIORITY_OR_OTHER||Adjusted mean|-2.07||||0.22|TWO_SIDED|95.0|-5.38|1.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||1.25|-5.38|0.220
71931940|NCT01494649|143384819|SUPERIORITY_OR_OTHER||Mean adjusted difference|8.69||||0.0004|TWO_SIDED|95.0|3.96|13.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.||13.43|3.96|0.0004
71931941|NCT03467971|143384820|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|175.6652|||||TWO_SIDED|90.0|153.779|200.6664||||||Statistical Analysis for Metformin||200.6664|153.7790|
71931942|NCT03467971|143384820|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|104.457|||||TWO_SIDED|90.0|97.766|111.606||||||Statistical Analysis for Gliclazide||111.6060|97.7660|
71931943|NCT03467971|143384821|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|180.7734|||||TWO_SIDED|90.0|157.0135|208.1287||||||Statistical Analysis for Metformin||208.1287|157.0135|
71690577|NCT01001520|142897285|SUPERIORITY_OR_OTHER|||||||0.88||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the right dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.88
71690578|NCT01001520|142897286|SUPERIORITY_OR_OTHER|||||||0.017||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Accuracy was examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would increase subject's accuracy during the N-back working memory task.||||0.017
71690579|NCT01001520|142897287|SUPERIORITY_OR_OTHER|||||||0.88||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would reduce subject's reaction time during the N-back working memory task.||||0.88
71690580|NCT01001520|142897288|SUPERIORITY_OR_OTHER|||||||0.85||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers would smoke fewer cigarettes while taking tolcapone (vs. placebo).||||0.85
71690581|NCT01001520|142897289|SUPERIORITY_OR_OTHER|||||||0.4||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience less cigarette craving during their 24-hour abstinence period.||||0.40
71690582|NCT01001520|142897290|SUPERIORITY_OR_OTHER|||||||0.43||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience fewer withdrawal symptoms during their 24-hour abstinence period.||||0.43
71690583|NCT01001520|142897291|SUPERIORITY_OR_OTHER|||||||0.18||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the left dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.18
71931944|NCT03467971|143384821|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.0818|||||TWO_SIDED|90.0|98.0047|112.6699||||||Statistical Analysis for Gliclazide||112.6699|98.0047|
71931945|NCT03467971|143384822|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|127.7779|||||TWO_SIDED|90.0|110.2732|148.0612||||||Statistical Analysis for Metformin||148.0612|110.2732|
71690584|NCT01001520|142897292|SUPERIORITY_OR_OTHER|||||||0.67||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the dorsal cingulate/medial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.67
71690585|NCT01001520|142897293|SUPERIORITY_OR_OTHER|||||||0.98||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the posterior cingulate cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.98
71690586|NCT01001520|142897294|SUPERIORITY_OR_OTHER|||||||0.002||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the ventromedial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."||||0.002
71690587|NCT02541422|142897295|SUPERIORITY|||||||0.45||||||p-value calculated for the total hangover scale|Wilcoxon (Mann-Whitney)|||||||0.45
71690588|NCT02541422|142897295|SUPERIORITY|||||||0.93||||||p value calculated for symptom of headache|Wilcoxon (Mann-Whitney)|||||||0.93
71690589|NCT02541422|142897295|SUPERIORITY|||||||0.11||||||p value calculated for symptom of nausea|Wilcoxon (Mann-Whitney)|||||||0.11
71690590|NCT02541422|142897295|SUPERIORITY|||||||0.72||||||p value calculated for symptom of weakness|Wilcoxon (Mann-Whitney)|||||||0.72
71931946|NCT03467971|143384822|EQUIVALENCE|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.4183|||||TWO_SIDED|90.0|94.5723|117.5081||||||Statistical Analysis for Gliclazide||117.5081|94.5723|
71931947|NCT02720094|143384844|SUPERIORITY||A bias-adjusted hazard ratio|0.34||||0.0005|TWO_SIDED|95.0|0.18|0.62|||Regression, Cox||The bias-adjusted hazard ratio, CI, and p-value account for the group-sequential trial design and the early stopping time.|||0.62|0.18|0.0005
71931948|NCT02720094|143384844|SUPERIORITY||Hazard Ratio (HR)|0.328||||0.0005|TWO_SIDED|95.0|0.18|0.61|||Regression, Cox||The unadjusted hazard ratio is based on a Cox proportional hazards model stratified by region.|||0.61|0.18|0.0005
71931949|NCT02720094|143384846|SUPERIORITY||Hazard Ratio (HR)|0.21|||<|0.001|TWO_SIDED|95.0|0.1|0.45||The P-Values are two-sided.|Regression, Cox|||The analysis population Injection Step 2 Efficacy consists of the subset of the mITT population who received at least one injection and had at least one HIV test result after the week 5 injection visit.||0.45|0.10|<0.001
71931950|NCT02913261|143384855|SUPERIORITY||Odds Ratio (OR)|2.64|||<|0.0001|TWO_SIDED|95.0|1.65|4.22|||Stratified Cochran-Mantel-Haenszel|||||4.22|1.65|<.0001
71690591|NCT00411450|142897328|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-11.0|21.0|||||Difference = Wild type - Mutant|Difference at Week 17||21|-11|
71931951|NCT02913261|143384856|SUPERIORITY||Odds Ratio (OR)|2.38||||0.0005|TWO_SIDED|95.0|1.43|3.94|||Stratified Cochran-Mantel-Haenszel|||||3.94|1.43|0.0005
71931952|NCT02913261|143384857|SUPERIORITY||Odds Ratio (OR)|1.98||||0.0029|TWO_SIDED|95.0|1.24|3.17|||Stratified Cochran-Mantel-Haenszel|||||3.17|1.24|0.0029
71931953|NCT02913261|143384869|SUPERIORITY||Odds Ratio (OR)|3.07|||<|0.0001|TWO_SIDED|95.0|1.8|5.25|||Stratified Cochran-Mantel-Haenszel|||||5.25|1.80|<.0001
71931954|NCT01236053|143384882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.0002|TWO_SIDED|95.0|1.07|1.24|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)"|||1.24|1.07|0.0002
71690592|NCT00411450|142897328|SUPERIORITY_OR_OTHER||Difference|8.0|||||TWO_SIDED|95.0|-9.0|23.0||||||Difference at Week 25||23|-9|
71931955|NCT01236053|143384882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.0976|TWO_SIDED|95.0|0.99|1.15|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.99|0.0976
71931956|NCT01236053|143384882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.23|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)"|||1.36|1.23|<0.0001
71931957|NCT01236053|143384882|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||<|0.0001|TWO_SIDED|95.0|1.13|1.26|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|1.13|<0.0001
71931958|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.1468|TWO_SIDED|95.0|0.97|1.23|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.23|0.97|0.1468
71931959|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.8545|TWO_SIDED|95.0|0.9|1.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.90|0.8545
71931960|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.27|1.48|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.48|1.27|<0.0001
71931961|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27|||<|0.0001|TWO_SIDED|95.0|1.18|1.37|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.37|1.18|<0.0001
71931962|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0033|TWO_SIDED|95.0|1.07|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.43|1.07|0.0033
71931963|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0474|TWO_SIDED|95.0|1.0|1.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.33|1.00|0.0474
71931964|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||<|0.0001|TWO_SIDED|95.0|1.16|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.16|<0.0001
71931965|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0008|TWO_SIDED|95.0|1.08|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.32|1.08|0.0008
71931966|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.019|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0190
71931967|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.3366|TWO_SIDED|95.0|0.94|1.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.21|0.94|0.3366
71690593|NCT00411450|142897330|SUPERIORITY_OR_OTHER||Difference|7.0|||||TWO_SIDED|95.0|-11.0|23.0|||||Difference = Wild type - Mutant|||23|-11|
71931968|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0001|TWO_SIDED|95.0|1.09|1.31|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.31|1.09|0.0001
71931969|NCT01236053|143384883|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.0464|TWO_SIDED|95.0|1.0|1.2|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.20|1.00|0.0464
71931970|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1194|TWO_SIDED|95.0|0.97|1.26|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.26|0.97|0.1194
71931971|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.7004|TWO_SIDED|95.0|0.9|1.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.90|0.7004
71931972|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37|||<|0.0001|TWO_SIDED|95.0|1.26|1.49|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.49|1.26|<0.0001
71931973|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26|||<|0.0001|TWO_SIDED|95.0|1.16|1.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.38|1.16|<0.0001
71931974|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0134|TWO_SIDED|95.0|1.03|1.34|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.34|1.03|0.0134
71931975|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.1592|TWO_SIDED|95.0|0.96|1.25|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.25|0.96|0.1592
71690594|NCT00411450|142897331|SUPERIORITY_OR_OTHER||Difference|12.5|||||TWO_SIDED|95.0|-6.3|31.4|||||Difference = Wild type - Mutant|Difference at Week 17||31.4|-6.3|
71690595|NCT00411450|142897331|SUPERIORITY_OR_OTHER||Difference|10.9|||||TWO_SIDED|95.0|-8.4|30.2||||||Difference at Week 25||30.2|-8.4|
71690596|NCT00411450|142897332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
71690597|NCT00411450|142897333|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0|||||Difference = Wild type - Mutant|Difference at Week 17||25|-14|
71690598|NCT00411450|142897333|SUPERIORITY_OR_OTHER||Difference|6.0|||||TWO_SIDED|95.0|-14.0|25.0||||||Difference at Week 25||25|-14|
71690599|NCT00411450|142897334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.2|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||2.0|0.2|
71690600|NCT00411450|142897335|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.4|0.9|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||0.9|0.4|
71690601|NCT00411450|142897336|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.1|0.5|
71690602|NCT00411450|142897337|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.5|1.2|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).|||1.2|0.5|
71690603|NCT00872521|142897341|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.09
71690604|NCT00872521|142897342|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
71690605|NCT00872521|142897343|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.23
71690606|NCT00872521|142897344|SUPERIORITY_OR_OTHER|||||||0.56|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.56
71690607|NCT00872521|142897345|SUPERIORITY_OR_OTHER|||||||0.01|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.01
71690608|NCT00872521|142897346|SUPERIORITY_OR_OTHER|||||||0.28|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified||||0.28
71931976|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35|||<|0.0001|TWO_SIDED|95.0|1.24|1.47|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.47|1.24|<0.0001
71690609|NCT00614874|142897356|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||Comparison is between baseline and week 12|ANOVA|||||||0.048
71690610|NCT00614874|142897357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.0|STANDARD_DEVIATION|35.0||0.183||95.0||||comparison was at baseline and week 12|Friedman|||||||0.183
71690611|NCT00614874|142897358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.95||0.398||95.0||||Comparison was at baseline and week 12|Friedman|||||||0.398
71690612|NCT01468454|142897360|OTHER||Specificity|89.5|||||TWO_SIDED|95.0|75.2|97.1||||||||97.1|75.2|
71690613|NCT01468454|142897360|OTHER||Sensitivity|83.9|||||TWO_SIDED|95.0|72.3|92.0||||||||92|72.3|
71690614|NCT02028507|142897387|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.003|TWO_SIDED|95.0|0.55|0.89|||Regression, Cox|||This statistical Analysis corresponds to Global health status/quality of life scale||0.89|0.55|0.003
71690615|NCT02028507|142897387|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.5|0.76|||Regression, Cox|||This statistical Analysis corresponds to Physical functioning scale||0.76|0.50|<0.001
71690616|NCT02028507|142897387|SUPERIORITY||Hazard Ratio (HR)|0.63|||<|0.001|TWO_SIDED|95.0|0.51|0.79|||Regression, Cox|||This statistical Analysis corresponds to Role functioning scale||0.79|0.51|<0.001
71690617|NCT02028507|142897387|SUPERIORITY||Hazard Ratio (HR)|0.97||||0.818|TWO_SIDED|95.0|0.76|1.25|||Regression, Cox|||This statistical Analysis corresponds to Emotional functioning scale||1.25|0.76|0.818
71690618|NCT02028507|142897387|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.004|TWO_SIDED|95.0|0.54|0.89|||Regression, Cox|||This statistical Analysis corresponds to Cognitive functioning scale||0.89|0.54|0.004
71690619|NCT02028507|142897387|SUPERIORITY||Hazard Ratio (HR)|0.62|||<|0.001|TWO_SIDED|95.0|0.49|0.78|||Regression, Cox|||This Statistical Analysis corresponds to Social functioning scale||0.78|0.49|<0.001
71690620|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.001|TWO_SIDED|95.0|0.57|0.86|||Regression, Cox|||This Statistical Analysis corresponds to Fatigue scale||0.86|0.57|0.001
71690621|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.45|0.76|||Regression, Cox|||This Statistical Analysis corresponds to Nausea and vomiting scale||0.76|0.45|<0.001
71690622|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.042|TWO_SIDED|95.0|0.62|0.99|||Regression, Cox|||This Statistical Analysis corresponds to Pain scale||0.99|0.62|0.042
71690623|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.599|TWO_SIDED|95.0|0.81|1.44|||Regression, Cox|||This Statistical Analysis corresponds to Dyspnea scale||1.44|0.81|0.599
71690624|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.196|TWO_SIDED|95.0|0.64|1.1|||Regression, Cox|||This Statistical Analysis corresponds to Insomnia scale||1.10|0.64|0.196
71690625|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.011|TWO_SIDED|95.0|0.54|0.92|||Regression, Cox|||This Statistical Analysis corresponds to Appetite loss scale||0.92|0.54|0.011
71690626|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.564|TWO_SIDED|95.0|0.83|1.41|||Regression, Cox|||This Statistical Analysis corresponds to Constipation scale||1.41|0.83|0.564
71690627|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.42|||<|0.001|TWO_SIDED|95.0|0.32|0.55|||Regression, Cox|||This Statistical Analysis corresponds to Diarrhea scale||0.55|0.32|<0.001
71690628|NCT02028507|142897388|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.118|TWO_SIDED|95.0|0.56|1.07|||Regression, Cox|||This Statistical Analysis corresponds to Financial difficulties scale||1.07|0.56|0.118
71931977|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25|||<|0.0001|TWO_SIDED|95.0|1.14|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.36|1.14|<0.0001
71931978|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.0131|TWO_SIDED|95.0|1.03|1.33|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.33|1.03|0.0131
71931979|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.2731|TWO_SIDED|95.0|0.95|1.22|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.22|0.95|0.2731
71931980|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0012|TWO_SIDED|95.0|1.06|1.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.28|1.06|0.0012
71931981|NCT01236053|143384884|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.1477|TWO_SIDED|95.0|0.98|1.17|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.17|0.98|0.1477
71931982|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0369|TWO_SIDED|95.0|1.01|1.41|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||1.41|1.01|0.0369
71931983|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.3132|TWO_SIDED|95.0|0.92|1.29|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.29|0.92|0.3132
71931984|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0762|TWO_SIDED|95.0|0.99|1.26|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.26|0.99|0.0762
71931985|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.7243|TWO_SIDED|95.0|0.91|1.15|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.15|0.91|0.7243
71931986|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0775|TWO_SIDED|95.0|0.97|1.65|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||1.65|0.97|0.0775
71931987|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.2649|TWO_SIDED|95.0|0.89|1.52|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.52|0.89|0.2649
71931988|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.0257|TWO_SIDED|95.0|1.02|1.43|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||1.43|1.02|0.0257
71931989|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.254|TWO_SIDED|95.0|0.93|1.3|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.30|0.93|0.2540
71931990|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5141|TWO_SIDED|95.0|0.76|1.75|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||1.75|0.76|0.5141
71931991|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8208|TWO_SIDED|95.0|0.69|1.6|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.60|0.69|0.8208
71931992|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0562|TWO_SIDED|95.0|0.99|1.62|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||1.62|0.99|0.0562
71931993|NCT01236053|143384885|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.2596|TWO_SIDED|95.0|0.9|1.47|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.47|0.90|0.2596
71931994|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.0709|TWO_SIDED|95.0|0.99|1.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.28|0.99|0.0709
71931995|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.4996|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.4996
71931996|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||<|0.0001|TWO_SIDED|95.0|1.23|1.45|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.45|1.23|<0.0001
71931997|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24|||<|0.0001|TWO_SIDED|95.0|1.14|1.35|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.35|1.14|<0.0001
71931998|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.0062|TWO_SIDED|95.0|1.05|1.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.36|1.05|0.0062
71931999|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.1144|TWO_SIDED|95.0|0.98|1.26|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.26|0.98|0.1144
71932000|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||<|0.0001|TWO_SIDED|95.0|1.3|1.55|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.55|1.30|<0.0001
71932001|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31|||<|0.0001|TWO_SIDED|95.0|1.2|1.43|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.43|1.20|<0.0001
71932002|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.0469|TWO_SIDED|95.0|1.0|1.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.29|1.00|0.0469
71932003|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.5169|TWO_SIDED|95.0|0.92|1.19|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.19|0.92|0.5169
71932004|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.0103|TWO_SIDED|95.0|1.03|1.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.24|1.03|0.0103
71932005|NCT01236053|143384886|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.4182|TWO_SIDED|95.0|0.95|1.14|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy."|||1.14|0.95|0.4182
71932006|NCT01236053|143384887|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|0.65||||0.3597|TWO_SIDED|95.0|0.26|1.62|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.62|0.26|0.3597
71932007|NCT01236053|143384887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.1845|TWO_SIDED|95.0|0.21|1.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.34|0.21|0.1845
71932008|NCT01236053|143384887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9142|TWO_SIDED|95.0|0.58|1.84|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.84|0.58|0.9142
71932009|NCT01236053|143384887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.6524|TWO_SIDED|95.0|0.49|1.57|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.57|0.49|0.6524
71932010|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.53||||0.2875|TWO_SIDED|95.0|0.17|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.70|0.17|0.2875
71932011|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.2042|TWO_SIDED|95.0|0.15|1.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.51|0.15|0.2042
71932012|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.4733|TWO_SIDED|95.0|0.38|8.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||8.06|0.38|0.4733
71932013|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.7867|TWO_SIDED|95.0|0.26|5.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||5.85|0.26|0.7867
71932014|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.53||||0.0049|TWO_SIDED|95.0|1.47|8.5|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||8.50|1.47|0.0049
71932015|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.87||||0.0218|TWO_SIDED|95.0|1.17|7.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||7.08|1.17|0.0218
71932016|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.849|TWO_SIDED|95.0|0.27|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.27|0.8490
71932017|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6263|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.46|0.22|0.6263
71932018|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.4122|TWO_SIDED|95.0|0.19|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.97|0.19|0.4122
71932019|NCT01236053|143384888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.51||||0.2642|TWO_SIDED|95.0|0.16|1.66|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.66|0.16|0.2642
71932020|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.7891|TWO_SIDED|95.0|0.31|2.43|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.43|0.31|0.7891
71690629|NCT02028507|142897389|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.659|TWO_SIDED|95.0|0.74|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Body image scale||1.21|0.74|0.659
71932021|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6216|TWO_SIDED|95.0|0.27|2.17|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.17|0.27|0.6216
71932022|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.6893|TWO_SIDED|95.0|0.31|5.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.96|0.31|0.6893
71690630|NCT02028507|142897389|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.928|TWO_SIDED|95.0|0.74|1.39|||Regression, Cox|||This Statistical Analysis corresponds to Future perspective scale||1.39|0.74|0.928
71690631|NCT02028507|142897390|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.029|TWO_SIDED|95.0|0.64|0.98|||Regression, Cox|||This Statistical Analysis corresponds to Systemic side-effects scale||0.98|0.64|0.029
71932023|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.9273|TWO_SIDED|95.0|0.24|4.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.84|0.24|0.9273
71932024|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.598|TWO_SIDED|95.0|0.47|3.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.78|0.47|0.5980
71932025|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8572|TWO_SIDED|95.0|0.38|3.18|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.18|0.38|0.8572
71932026|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7807|TWO_SIDED|95.0|0.26|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.77|0.26|0.7807
71932027|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.5579|TWO_SIDED|95.0|0.21|2.32|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.32|0.21|0.5579
71932028|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9932|TWO_SIDED|95.0|0.4|2.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.53|0.40|0.9932
71932029|NCT01236053|143384889|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.6901|TWO_SIDED|95.0|0.32|2.11|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.11|0.32|0.6901
71932030|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.431|TWO_SIDED|95.0|0.19|2.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.01|0.19|0.4310
71932031|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.3226|TWO_SIDED|95.0|0.17|1.79|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.79|0.17|0.3226
71932032|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.6206|TWO_SIDED|95.0|0.4|4.59|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.59|0.40|0.6206
71932033|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.8557|TWO_SIDED|95.0|0.33|3.84|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||3.84|0.33|0.8557
71932034|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.1498|TWO_SIDED|95.0|0.79|4.62|||Unadjusted Odds Ratio||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||4.62|0.79|0.1498
71932035|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.2645|TWO_SIDED|95.0|0.68|4.07|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||4.07|0.68|0.2645
71932036|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.5728|TWO_SIDED|95.0|0.16|2.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.79|0.16|0.5728
71932037|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.52||||0.3727|TWO_SIDED|95.0|0.12|2.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||2.21|0.12|0.3727
71690632|NCT02028507|142897390|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.571|TWO_SIDED|95.0|0.71|1.21|||Regression, Cox|||This Statistical Analysis corresponds to Breast symptoms scale||1.21|0.71|0.571
71690633|NCT02028507|142897390|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.187|TWO_SIDED|95.0|0.66|1.09|||Regression, Cox|||This Statistical Analysis corresponds to Arm symptoms scale||1.09|0.66|0.187
71932038|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.7743|TWO_SIDED|95.0|0.31|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.40|0.31|0.7743
71932039|NCT01236053|143384891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69||||0.4775|TWO_SIDED|95.0|0.24|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs."|||1.94|0.24|0.4775
71932040|NCT01236053|143384892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.33||||0.0032|TWO_SIDED|95.0|1.95|27.56|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||27.56|1.95|0.0032
71932041|NCT01236053|143384892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.39||||0.1251|TWO_SIDED|95.0|0.71|16.17|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||16.17|0.71|0.1251
71932042|NCT01236053|143384892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.22||||0.0261|TWO_SIDED|95.0|1.15|9.01|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||9.01|1.15|0.0261
71932043|NCT01236053|143384892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.209|TWO_SIDED|95.0|0.65|7.17|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.17|0.65|0.2090
71690634|NCT00718094|142897404|SUPERIORITY|||||||0.03|||||||Fisher Exact|||||||0.03
71932044|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
71932045|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
71932046|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
71932047|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21||||0.0269|TWO_SIDED|95.0|1.21|22.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||22.51|1.21|0.0269
71932048|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
71932049|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
71932050|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
71690635|NCT01808261|142897414|OTHER||Mean Difference (Net)|0.0443|STANDARD_ERROR_OF_MEAN|0.0809||0.713||95.0|-0.119|0.2||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 3/Day 90.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.2|-0.119|0.713
71932051|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
71932052|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
71932053|NCT01236053|143384893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9253|TWO_SIDED|95.0|0.1|7.82|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.82|0.10|0.9253
71932054|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
71932055|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.47||||0.0158|TWO_SIDED|95.0|1.78|258.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||258.8|1.78|0.0158
71932056|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.0||||0.0141|TWO_SIDED|95.0|1.43|25.11|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||25.11|1.43|0.0141
71932057|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.56||||0.0063|TWO_SIDED|95.0|1.83|40.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.02|1.83|0.0063
71932058|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.1888|TWO_SIDED|95.0|0.45|55.14|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||55.14|0.45|0.1888
71932059|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.999|TWO_SIDED|95.0|0.03|32.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||32.21|0.03|0.9990
71932060|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.75||||0.2885|TWO_SIDED|95.0|0.33|43.08|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||43.08|0.33|0.2885
71932061|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.9608|TWO_SIDED|95.0|0.06|13.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||13.87|0.06|0.9608
71932062|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
71932063|NCT01236053|143384894|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.9381||95.0|0.11|7.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.97|0.11|0.9381
71932064|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||220.5|1.81|0.0144
71932065|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|21.55||||0.0157|TWO_SIDED|95.0|1.78|260.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||260.2|1.78|0.0157
71932066|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.86||||0.0524|TWO_SIDED|95.0|0.99|15.14|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||15.14|0.99|0.0524
71932067|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.0333|TWO_SIDED|95.0|1.13|20.31|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||20.31|1.13|0.0333
71932068|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34||||0.2966|TWO_SIDED|95.0|0.35|32.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||32.06|0.35|0.2966
71932069|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.751|TWO_SIDED|95.0|0.03|12.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||12.31|0.03|0.7510
71932070|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.71||||0.1868|TWO_SIDED|95.0|0.4|113.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||113.4|0.40|0.1868
71932071|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.7558|TWO_SIDED|95.0|0.07|40.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||40.61|0.07|0.7558
71932072|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.33||||0.0944|TWO_SIDED|95.0|0.78|24.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||24.07|0.78|0.0944
71932073|NCT01236053|143384896|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.9244|TWO_SIDED|95.0|0.1|7.81|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital)."|||7.81|0.10|0.9244
71932074|NCT01236053|143384897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0963|TWO_SIDED|95.0|0.96|1.7|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.96|0.0963
71932075|NCT01236053|143384897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.671|TWO_SIDED|95.0|0.69|1.27|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.27|0.69|0.6710
71932076|NCT01236053|143384897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.54|2.2|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.20|1.54|<0.0001
71932077|NCT01236053|143384897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5|||<|0.0001|TWO_SIDED|95.0|1.24|1.81|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.81|1.24|<0.0001
71932078|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.1184|TWO_SIDED|95.0|0.92|2.18|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.18|0.92|0.1184
71932079|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8016|TWO_SIDED|95.0|0.59|1.5|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.50|0.59|0.8016
71932080|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.27|||<|0.0001|TWO_SIDED|95.0|1.77|2.91|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.91|1.77|<0.0001
71932081|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97|||<|0.0001|TWO_SIDED|95.0|1.51|2.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.58|1.51|<0.0001
71932082|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.6105|TWO_SIDED|95.0|0.65|2.08|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.08|0.65|0.6105
71932083|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.6797|TWO_SIDED|95.0|0.62|2.09|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.09|0.62|0.6797
71932084|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.0103|TWO_SIDED|95.0|1.12|2.39|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.39|1.12|0.0103
71932085|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1629|TWO_SIDED|95.0|0.89|2.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.00|0.89|0.1629
71932086|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.4713|TWO_SIDED|95.0|0.73|1.97|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.97|0.73|0.4713
71932087|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.4505|TWO_SIDED|95.0|0.49|1.38|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.49|0.4505
71690636|NCT01808261|142897415|OTHER||Mean Difference (Net)|0.0794|STANDARD_ERROR_OF_MEAN|0.0857||0.828|TWO_SIDED|95.0|-0.093|0.247||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg - placebo) is greater than 0 m/s at Month 6/Day 180.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.||0.247|-0.093|0.828
71932088|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.0284|TWO_SIDED|95.0|1.04|2.01|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.01|1.04|0.0284
71932089|NCT01236053|143384898|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.6262|TWO_SIDED|95.0|0.77|1.54|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.54|0.77|0.6262
71932090|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.0798|TWO_SIDED|95.0|0.95|2.41|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.41|0.95|0.0798
71932091|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.8357|TWO_SIDED|95.0|0.64|1.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.73|0.64|0.8357
71932092|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.29|||<|0.0001|TWO_SIDED|95.0|1.75|3.01|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.01|1.75|<0.0001
71932093|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.0001|TWO_SIDED|95.0|1.53|2.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.76|1.53|<0.0001
71932094|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7794|TWO_SIDED|95.0|0.63|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.85|0.63|0.7794
71932095|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.8075|TWO_SIDED|95.0|0.52|1.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.66|0.52|0.8075
71932096|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0001|TWO_SIDED|95.0|1.35|2.52|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.52|1.35|0.0001
71932097|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0161|TWO_SIDED|95.0|1.08|2.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.12|1.08|0.0161
71932098|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3972|TWO_SIDED|95.0|0.76|2.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.00|0.76|0.3972
71932099|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.495|TWO_SIDED|95.0|0.5|1.39|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.39|0.50|0.4950
71932100|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0601|TWO_SIDED|95.0|0.99|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.94|0.99|0.0601
71932101|NCT01236053|143384899|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.9286|TWO_SIDED|95.0|0.71|1.45|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.45|0.71|0.9286
71932102|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.5394|TWO_SIDED|95.0|0.63|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.39|0.63|0.5394
71932103|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.507|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.58|0.39|0.5070
71932104|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.5426|TWO_SIDED|95.0|0.73|1.83|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||1.83|0.73|0.5426
71932105|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.515|TWO_SIDED|95.0|0.52|1.38|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.38|0.52|0.5150
71932106|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53||||0.435|TWO_SIDED|95.0|0.53|4.42|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||4.42|0.53|0.4350
71932107|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13||||0.8276|TWO_SIDED|95.0|0.37|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||3.43|0.37|0.8276
71932108|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.4022|TWO_SIDED|95.0|0.69|2.5|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.50|0.69|0.4022
71932109|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8681|TWO_SIDED|95.0|0.48|1.86|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.86|0.48|0.8681
71932110|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.67||||0.6326|TWO_SIDED|95.0|0.2|13.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||13.86|0.20|0.6326
71932111|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.577|TWO_SIDED|95.0|0.21|16.86|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||16.86|0.21|0.5770
71932112|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.8087|TWO_SIDED|95.0|0.4|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.21|0.40|0.8087
71932113|NCT01236053|143384900|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8497|TWO_SIDED|95.0|0.31|2.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.64|0.31|0.8497
71932114|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.1528|TWO_SIDED|95.0|0.88|2.24|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.24|0.88|0.1528
71932115|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01||||0.9625|TWO_SIDED|95.0|0.62|1.65|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.65|0.62|0.9625
71932116|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.96|||<|0.0001|TWO_SIDED|95.0|1.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.59|1.48|<0.0001
71932117|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.7||||0.0006|TWO_SIDED|95.0|1.25|2.29|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.29|1.25|0.0006
71932118|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.28||||0.3515|TWO_SIDED|95.0|0.76|2.16|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.16|0.76|0.3515
71932119|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9069|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.82|0.59|0.9069
71932120|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001|TWO_SIDED|95.0|1.78|3.21|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.21|1.78|<0.0001
71932121|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04|||<|0.0001|TWO_SIDED|95.0|1.48|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||2.81|1.48|<0.0001
71932122|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5948|TWO_SIDED|95.0|0.7|1.88|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.88|0.70|0.5948
71932123|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.3984|TWO_SIDED|95.0|0.47|1.35|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.35|0.47|0.3984
71932124|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.1872|TWO_SIDED|95.0|0.89|1.79|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.79|0.89|0.1872
71932125|NCT01236053|143384901|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6772|TWO_SIDED|95.0|0.64|1.34|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD."|||1.34|0.64|0.6772
71932126|NCT01236053|143384902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.4933|TWO_SIDED|95.0|0.07|3.72|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||3.72|0.07|0.4933
71932127|NCT01236053|143384902|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.43||||0.4147|TWO_SIDED|95.0|0.06|3.27|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||3.27|0.06|0.4147
71932128|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.8257|TWO_SIDED|95.0|0.15|10.38|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||10.38|0.15|0.8257
71932129|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.9467|TWO_SIDED|95.0|0.13|9.02|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||9.02|0.13|0.9467
71690637|NCT01808261|142897417|OTHER||Mean Difference (Net)|2.408|STANDARD_ERROR_OF_MEAN|2.7495|||TWO_SIDED|95.0|-3.067|7.883||||||Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||7.883|-3.067|
71690638|NCT01808261|142897417|OTHER||Mean Difference (Net)|3.015|STANDARD_ERROR_OF_MEAN|2.8732|||TWO_SIDED|95.0|-2.704|8.735||||||Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||8.735|-2.704|
71690639|NCT01808261|142897417|OTHER||Mean Difference (Net)|2.435|STANDARD_ERROR_OF_MEAN|3.5633|||TWO_SIDED|95.0|-4.668|9.538||||||Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||9.538|-4.668|
71690640|NCT01808261|142897417|OTHER||Mean Difference (Net)|3.944|STANDARD_ERROR_OF_MEAN|3.5635|||TWO_SIDED|95.0|-3.15|11.037||||||Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.||11.037|-3.15|
71690641|NCT02609984|142897446|OTHER||Hazard Ratio (HR)|0.8568||||0.49|TWO_SIDED|95.0|0.5507|1.333||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.3330|0.5507|0.4900
71690642|NCT02609984|142897447|OTHER||Hazard Ratio (HR)|1.2145||||0.4737|TWO_SIDED|95.0|0.7131|2.0684||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.0684|0.7131|0.4737
71690643|NCT02609984|142897451|OTHER|||||||0.3645||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3645
71690644|NCT02609984|142897452|OTHER|||||||0.3466||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank|||||||0.3466
71690645|NCT02609984|142897453|OTHER||Hazard Ratio (HR)|0.7006||||0.1622|TWO_SIDED|95.0|0.4241|1.1574||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||1.1574|0.4241|0.1622
71932130|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9859|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9859
71690646|NCT02609984|142897454|OTHER||Hazard Ratio (HR)|1.1849||||0.6397|TWO_SIDED|95.0|0.5817|2.4134||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|||2.4134|0.5817|0.6397
71690647|NCT02609984|142897455|OTHER|||||||0.1128|||||||exact Pearson chi-square test|||||||0.1128
71690648|NCT02609984|142897456|OTHER||||||<|0.0001|||||||exact Pearson chi-square test|||||||<0.0001
71690649|NCT02609984|142897457|OTHER|||||||0.405|||||||exact Pearson chi-square test|||||||0.4050
71690650|NCT02609984|142897458|OTHER|||||||0.0127|||||||exact Pearson chi-square test|||||||0.0127
71690651|NCT02080364|142897460|SUPERIORITY|||||||0.3386||||||p-value for comparison to Placebo|Mixed Models Analysis|||||||0.3386
71690652|NCT02080364|142897460|SUPERIORITY|||||||0.1992||||||p-value for compairons to Placebo|Mixed Models Analysis|||||||0.1992
71690653|NCT02080364|142897461|SUPERIORITY|||||||0.9394||||||p-value for comparison to Placebo.|Mixed Models Analysis|||||||0.9394
71690654|NCT02080364|142897461|SUPERIORITY||||||||||||||||||MMRM model does not converge. LS Mean and p-value are NA.|||
71690655|NCT02504320|142897470|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0848|||||TWO_SIDED|90.0|0.9528|1.235|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.2350|0.9528|
71932131|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9857|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9857
71932132|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.986|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||0.00|0.00|0.9860
71932133|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9858|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9858
71690656|NCT02504320|142897470|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.7709|||||TWO_SIDED|90.0|0.6767|0.8782|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.8782|0.6767|
71932134|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9798|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||0.00|0.00|0.9798
71932135|NCT01236053|143384903|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.9796|TWO_SIDED|95.0|0.0|0.0|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||0.00|0.00|0.9796
71932136|NCT01236053|143384904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.6252|TWO_SIDED|95.0|0.2|14.84|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||14.84|0.20|0.6252
71932137|NCT01236053|143384904|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.7208|TWO_SIDED|95.0|0.17|13.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||13.28|0.17|0.7208
71932138|NCT01236053|143384906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12||||0.9141|TWO_SIDED|95.0|0.14|9.03|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||9.03|0.14|0.9141
71932139|NCT01236053|143384906|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.9613|TWO_SIDED|95.0|0.12|7.78|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||7.78|0.12|0.9613
71932140|NCT01236053|143384907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.0323|TWO_SIDED|95.0|1.02|1.57|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.57|1.02|0.0323
71932141|NCT01236053|143384907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.0682|TWO_SIDED|95.0|0.99|1.52|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.99|0.0682
71932142|NCT01236053|143384907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.0326|TWO_SIDED|95.0|1.01|1.4|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.40|1.01|0.0326
71932143|NCT01236053|143384907|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.0699|TWO_SIDED|95.0|0.99|1.36|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.36|0.99|0.0699
71932144|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.2893|TWO_SIDED|95.0|0.86|1.69|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.86|0.2893
71932145|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.4301|TWO_SIDED|95.0|0.82|1.61|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.61|0.82|0.4301
71690657|NCT02504320|142897470|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9389|||||TWO_SIDED|90.0|0.8246|1.0689|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0689|0.8246|
71690658|NCT02504320|142897471|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0435|||||TWO_SIDED|90.0|0.984|1.1066|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.1066|0.9840|
71761188|NCT00611026|143024039|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0217
71932146|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.0806|TWO_SIDED|95.0|0.97|1.58|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.58|0.97|0.0806
71932147|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.1226|TWO_SIDED|95.0|0.95|1.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.55|0.95|0.1226
71932148|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.3502|TWO_SIDED|95.0|0.8|1.89|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.89|0.80|0.3502
71932149|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4654|TWO_SIDED|95.0|0.76|1.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.81|0.76|0.4654
71932150|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.3987|TWO_SIDED|95.0|0.59|1.23|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.23|0.59|0.3987
71932151|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.3349|TWO_SIDED|95.0|0.58|1.2|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.20|0.58|0.3349
71932152|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.0827|TWO_SIDED|95.0|0.96|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.98|0.96|0.0827
71932153|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0932|TWO_SIDED|95.0|0.95|1.96|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.96|0.95|0.0932
71932154|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.013|TWO_SIDED|95.0|1.07|1.8|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.80|1.07|0.0130
71932155|NCT01236053|143384908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.0241|TWO_SIDED|95.0|1.04|1.75|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.75|1.04|0.0241
71932156|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.5043|TWO_SIDED|95.0|0.77|1.68|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.68|0.77|0.5043
71932157|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.7129|TWO_SIDED|95.0|0.73|1.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.59|0.73|0.7129
71932158|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.2055|TWO_SIDED|95.0|0.91|1.57|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.57|0.91|0.2055
71932159|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.3005|TWO_SIDED|95.0|0.88|1.52|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.52|0.88|0.3005
71932160|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.2849|TWO_SIDED|95.0|0.84|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.77|0.84|0.2849
71932161|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.365|TWO_SIDED|95.0|0.82|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.72|0.82|0.3650
71932162|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.7559|TWO_SIDED|95.0|0.78|1.4|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.40|0.78|0.7559
71932163|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.852|TWO_SIDED|95.0|0.77|1.37|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.37|0.77|0.8520
71932164|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.44||||0.0459|TWO_SIDED|95.0|1.01|2.06|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.06|1.01|0.0459
71932165|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.0542|TWO_SIDED|95.0|0.99|2.04|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.04|0.99|0.0542
71932166|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.0312|TWO_SIDED|95.0|1.03|1.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.74|1.03|0.0312
71932167|NCT01236053|143384909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.3||||0.0508|TWO_SIDED|95.0|1.0|1.7|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.70|1.00|0.0508
71932168|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0892|TWO_SIDED|95.0|0.94|2.42|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag)."|||2.42|0.94|0.0892
71932169|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.48||||0.1043|TWO_SIDED|95.0|0.92|2.39|||Conditional Logistic Regression||"Comparison: \> 1 year (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.39|0.92|0.1043
71932170|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.0101|TWO_SIDED|95.0|1.1|2.06|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag)."|||2.06|1.10|0.0101
71932171|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46||||0.0186|TWO_SIDED|95.0|1.07|2.0|||Conditional Logistic Regression||"Comparison: \> 1 year (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.00|1.07|0.0186
71932172|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.69||||0.1458|TWO_SIDED|95.0|0.83|3.43|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag)."|||3.43|0.83|0.1458
71932173|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.62||||0.1859|TWO_SIDED|95.0|0.79|3.29|||Conditional Logistic Regression||"Comparison: \> 2 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.29|0.79|0.1859
71932174|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.0122|TWO_SIDED|95.0|1.13|2.72|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag)."|||2.72|1.13|0.0122
71932175|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.0162|TWO_SIDED|95.0|1.1|2.67|||Conditional Logistic Regression||"Comparison: \> 2 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||2.67|1.10|0.0162
71932176|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.7573|TWO_SIDED|95.0|0.19|3.36|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag)."|||3.36|0.19|0.7573
71690659|NCT02504320|142897471|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.8777|||||TWO_SIDED|90.0|0.8274|0.9311|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9311|0.8274|
71690660|NCT02504320|142897471|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.954|||||TWO_SIDED|90.0|0.8996|1.0117|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0117|0.8996|
71690661|NCT02504320|142897472|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0283|||||TWO_SIDED|90.0|0.9691|1.0911|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).||1.0911|0.9691|
71690662|NCT02504320|142897472|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9056|||||TWO_SIDED|90.0|0.8516|0.963|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).||0.9630|0.8516|
71690663|NCT02504320|142897472|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimates|0.9463|||||TWO_SIDED|90.0|0.8909|1.0051|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).||1.0051|0.8909|
71690664|NCT00941304|142897478|SUPERIORITY_OR_OTHER||LS Mean Difference|3.34||||0.4739|TWO_SIDED|95.0|-5.94|12.62|||ANCOVA|||||12.62|-5.94|.4739
71690665|NCT00941304|142897478|SUPERIORITY_OR_OTHER||LS Mean Difference|6.26||||0.2183|TWO_SIDED|95.0|-3.81|16.34|||ANCOVA|||||16.34|-3.81|.2183
71690666|NCT00941304|142897478|SUPERIORITY_OR_OTHER||LS Mean Difference|8.74||||0.0809|TWO_SIDED|95.0|-1.11|18.56|||ANCOVA|||||18.56|-1.11|.0809
71690667|NCT03293394|142897489|SUPERIORITY||||||=|0.001|||||||ANCOVA|||||||=0.001
71690668|NCT03293394|142897490|SUPERIORITY|||||||0.011|||||||ANOVA|||||||0.011
71690669|NCT03293394|142897491|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
71690670|NCT03293394|142897492|SUPERIORITY|||||||0.652|||||||ANCOVA|||||||0.652
71690671|NCT03293394|142897493|SUPERIORITY|||||||0.19|||||||ANCOVA|||||||0.190
71932177|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.7088|TWO_SIDED|95.0|0.18|3.21|||Conditional Logistic Regression||"Comparison: \> 3 years (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.21|0.18|0.7088
71932178|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.84||||0.0787|TWO_SIDED|95.0|0.93|3.64|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag)."|||3.64|0.93|0.0787
71932179|NCT01236053|143384910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.0873|TWO_SIDED|95.0|0.92|3.58|||Conditional Logistic Regression||"Comparison: \> 3 years (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||3.58|0.92|0.0873
71932180|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.17||||0.4233|TWO_SIDED|95.0|0.8|1.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.70|0.80|0.4233
71932181|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.5908|TWO_SIDED|95.0|0.76|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.76|0.5908
71932182|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.054|TWO_SIDED|95.0|1.0|1.67|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.67|1.00|0.0540
71690672|NCT03293394|142897494|SUPERIORITY|||||||0.011|||||||ANCOVA|||||||0.011
71690673|NCT03293394|142897495|SUPERIORITY|||||||0.003|||||||ANCOVA|||||||0.003
71690674|NCT03293394|142897496|SUPERIORITY|||||||0.001|||||||ANOVA|||||||0.001
71690675|NCT00086450|142897497|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|7.9||||0.005||95.0|3.3|12.5|||Regression, Cox|||||12.5|3.3|0.005
71690676|NCT00086450|142897498|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.74||||0.004||95.0|1.91|3.89|||Regression, Cox|||||3.89|1.91|0.004
71690677|NCT00086450|142897499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.4||||0.049||95.0|||||Log Rank|||||||0.049
71690678|NCT00086450|142897500|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||Regression, Cox|||||||0.68
71690679|NCT01408901|142897501|SUPERIORITY||Mean Difference (Final Values)|28.7||||0.052|TWO_SIDED|95.0|5.1|52.3||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||52.3|5.1|0.052
71690680|NCT01408901|142897501|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.91|TWO_SIDED|95.0|-30.2|17.6||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||17.6|-30.2|0.91
71690681|NCT01408901|142897501|SUPERIORITY||Mean Difference (Final Values)|-1.4||||0.91|TWO_SIDED|95.0|-25.2|22.4||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||22.4|-25.2|0.91
71690682|NCT01408901|142897501|SUPERIORITY||Mean Difference (Final Values)|33.6||||0.02|TWO_SIDED|95.0|9.4|57.7||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||57.7|9.4|0.02
71690683|NCT01408901|142897502|SUPERIORITY||Hodges-Lehmann estimator|-0.61||||0.49|TWO_SIDED|95.0|-1.67|0.44||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.44|-1.67|0.49
71690684|NCT01408901|142897502|SUPERIORITY||Hodges-Lehmann estimator|-0.67||||0.49|TWO_SIDED|95.0|-1.84|0.51||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||0.51|-1.84|0.49
71690685|NCT01408901|142897502|SUPERIORITY||Hodges-Lehmann estimator|0.36||||0.49|TWO_SIDED|95.0|-0.66|1.38||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.38|-0.66|0.49
71690686|NCT01408901|142897502|SUPERIORITY||Hodges-Lehmann estimator|0.48||||0.49|TWO_SIDED|95.0|-0.64|1.59||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)|||||1.59|-0.64|0.49
71690687|NCT01408901|142897503|SUPERIORITY||Mean Difference (Final Values)|3.6|||<|0.01|TWO_SIDED|95.0|2.1|5.0||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.0|2.1|<0.01
71690688|NCT01408901|142897503|SUPERIORITY||Mean Difference (Final Values)|-0.7||||0.44|TWO_SIDED|95.0|-2.1|0.8||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.8|-2.1|0.44
71690689|NCT01408901|142897503|SUPERIORITY||Mean Difference (Final Values)|-0.6||||0.44|TWO_SIDED|95.0|-2.1|0.9||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||0.9|-2.1|0.44
71690690|NCT01408901|142897503|SUPERIORITY||Mean Difference (Final Values)|3.7|||<|0.01|TWO_SIDED|95.0|2.2|5.2||The P value is a Hochberg-adjusted P value.|t-test, 2 sided|||||5.2|2.2|<0.01
71690691|NCT01408901|142897504|SUPERIORITY||Mean Difference (Final Values)|-0.006||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
71690692|NCT01408901|142897505|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.03|TWO_SIDED|95.0|-0.01|-0.001|||t-test, 2 sided|||||-0.001|-0.010|0.03
71690693|NCT01408901|142897506|SUPERIORITY||Mean Difference (Final Values)|-0.005||||0.09|TWO_SIDED|95.0|-0.012|0.001|||t-test, 2 sided|||||0.001|-0.012|0.09
71690694|NCT01408901|142897507|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.17|TWO_SIDED|95.0|-0.009|0.002|||t-test, 2 sided|||||0.002|-0.009|0.17
71690695|NCT02497404|142897508|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|30.1|62.8||||||||62.8|30.1|
71690696|NCT02497404|142897509|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
71690697|NCT02497404|142897510|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
71690698|NCT02497404|142897511|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|89.7|||||TWO_SIDED|95.0|75.8|97.1||||||||97.1|75.8|
71690699|NCT02497404|142897512|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.|Proportion (percent)|64.1|||||TWO_SIDED|95.0|47.2|78.8||||||||78.8|47.2|
71690700|NCT02497404|142897513|OTHER||Proportion (percent)|38.5|||||TWO_SIDED|95.0|23.4|55.4||||||Clopper-Pearson (exact) 95% confidence interval provided for the survival proportion.||55.4|23.4|
71690701|NCT02497404|142897514|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the graft failure proportion.|Proportion (percent)|2.6|||||TWO_SIDED|95.0|0.07|13.5||||||||13.5|0.07|
71690702|NCT02497404|142897515|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the GVHD proportion.|Proportion (percent)|33.3|||||TWO_SIDED|95.0|19.1|50.2||||||||50.2|19.1|
71690703|NCT02497404|142897516|OTHER|Clopper-Pearson (exact) 95% confidence interval provided for the high-risk extensive chronic graft-versus-host-disease proportion.|Proportion (percent)|5.1|||||TWO_SIDED|95.0|0.63|15.3||||||||15.3|0.63|
71690704|NCT04550364|142897543|OTHER|Semi-structured interview, background information, DSM 5 diagnosis and ED symptoms.||||||||||||||||23 of 24 women were used ideal type analysis as the methods. EDE-Q and DSM 5 diagnosis were measured.|Ideal type analysis as main method of analysis|||
71690705|NCT04550364|142897544|OTHER|Interpretative phenomenological analysis (IPA)||||||||||||||||of the 24 mothers there were 7 of them that had undergone In vitro fertilization. These women were interviewed twice and IPA were used in analysis the material.|IPA|||
71690706|NCT04550364|142897545|OTHER|Grounded theory was used analysis method. 5 distinct ED trajectories into motherhood were identified based on the womens experiences from pregnancy to postpartum.||||||||||||||||This study was based on interviews conducted with 24 participants during pregnancy and postpartum. Semi-structured interview with 24 women at two time points: 1. During pregnancy and 2. 4-6 months after birth. DSM 5 diagnosis at both time points were also assessed and symptoms at eating disorders through EDE-Q.|Qualitative methods using Ground theory|||
71690707|NCT01765569|142897588|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.82|||||TWO_SIDED|90.0|1.63|2.02||||||||2.02|1.63|
71690708|NCT01765569|142897592|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.47|||||TWO_SIDED|90.0|1.3|1.65||||||||1.65|1.3|
71690709|NCT05568797|142897618|NON_INFERIORITY|The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (\<=) 1.5.|GMT Ratio|1.32|||||TWO_SIDED|0.95|1.13|1.53|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.53|1.13|
71761100|NCT00494676|143023808|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.2|||=|0.001|TWO_SIDED|95.0|1.8|21.0|||McNemar||The marginal odds ratio based on discordant pairs was computed.|The analysis used a McNemar test for data combined across both periods of the crossover. We estimated that 70% and 35% of participants would say yes to the real and sham prisms, respectively. For a 2-tailed test, the minimum sample size to detect a 35% difference in yes responses to real and sham prisms was 57 participants, assuming 30% overlap (30% said yes to both pairs of glasses), power of 90% and α of 1%. Assuming an attrition rate of 20%, we planned to enroll 68 participants.||21.0|1.8|= 0.001
71690710|NCT05568797|142897618|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.91|1.18|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.18|0.91|
71690711|NCT05568797|142897618|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|0.97|||||TWO_SIDED|0.95|0.9|1.06|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.06|0.90|
71690712|NCT05568797|142897618|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is \<=1.5.|GMT Ratio|1.04|||||TWO_SIDED|0.95|0.95|1.13|||||The comparison was done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata influenza strain included in the FLU vaccine, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||1.13|0.95|
71690713|NCT05568797|142897619|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-A neutralizing antibody vaccine is \<=1.5.|GMT Ratio|0.99|||||TWO_SIDED|0.95|0.87|1.12|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group and the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group).||1.12|0.87|
71690714|NCT05568797|142897620|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-B neutralizing antibody vaccine is \<=1.5.|GMT Ratio|1.16|||||TWO_SIDED|0.95|1.03|1.3|||||The comparison is done using adjusted group ratio of GMT (ANCOVA model applied to the logarithm- transformed titers). The ANCOVA model included the treatment group, the age category as fixed effects and the pre-dose log-10 titer as covariate.|To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the CoAd Group and Day 61 for the Control Group).||1.30|1.03|
71690715|NCT05568797|142897621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|10.25|||||TWO_SIDED|0.95|3.5|16.9||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||16.90|3.50|
71690716|NCT05568797|142897621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|1.66|||||TWO_SIDED|0.95|-5.16|8.47||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||8.47|-5.16|
71690717|NCT05568797|142897621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.25|||||TWO_SIDED|0.95|-4.92|5.46||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||5.46|-4.92|
71690718|NCT05568797|142897621|NON_INFERIORITY|The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is \<=10% for anti-HI antibodies.|Difference of Percentage|0.79|||||TWO_SIDED|0.95|-4.54|6.17||||||To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).||6.17|-4.54|
71932183|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.62|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.62|0.96|0.0939
71932184|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.214|TWO_SIDED|95.0|0.87|1.87|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||1.87|0.87|0.2140
71932185|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.8|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.80|0.84|0.2940
71932186|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.8352|TWO_SIDED|95.0|0.71|1.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.32|0.71|0.8352
71932187|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.7809|TWO_SIDED|95.0|0.7|1.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.31|0.70|0.7809
71932188|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.0921|TWO_SIDED|95.0|0.95|1.94|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||1.94|0.95|0.0921
71932189|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.1091|TWO_SIDED|95.0|0.94|1.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.92|0.94|0.1091
71932190|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.0564|TWO_SIDED|95.0|0.99|1.68|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.68|0.99|0.0564
71932191|NCT01236053|143384911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.25||||0.0939|TWO_SIDED|95.0|0.96|1.63|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease."|||1.63|0.96|0.0939
71932192|NCT01236053|143384912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.58||||0.3082|TWO_SIDED|95.0|0.31|41.71|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||41.71|0.31|0.3082
71932193|NCT01236053|143384912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.9||||0.3999|TWO_SIDED|95.0|0.24|34.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||34.69|0.24|0.3999
71932194|NCT01236053|143384912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42||||0.7509|TWO_SIDED|95.0|0.16|12.52|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||12.52|0.16|0.7509
71932195|NCT01236053|143384912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.6303|TWO_SIDED|95.0|0.18|17.07|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||17.07|0.18|0.6303
71932196|NCT01236053|143384913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
71932197|NCT01236053|143384913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
71932198|NCT01236053|143384913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
71932199|NCT01236053|143384913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
71932200|NCT01236053|143384914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
71932201|NCT01236053|143384914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
71932202|NCT01236053|143384914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
71932203|NCT01236053|143384914|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.50|0.1118
71932204|NCT01236053|143384916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||108.8|0.37|0.2038
71932205|NCT01236053|143384916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.63||||0.2866|TWO_SIDED|95.0|0.28|77.51|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||77.51|0.28|0.2866
71932206|NCT01236053|143384916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.32||||0.2038|TWO_SIDED|95.0|0.37|108.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||108.8|0.37|0.2038
71932207|NCT01236053|143384916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.4||||0.1118|TWO_SIDED|95.0|0.5|839.0|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis."|||839.0|0.5|0.1118
71932208|NCT01236053|143384917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.9614|TWO_SIDED|95.0|0.58|1.69|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||1.69|0.58|0.9614
71932209|NCT01236053|143384917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.5179|TWO_SIDED|95.0|0.49|1.44|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.44|0.49|0.5179
71932210|NCT01236053|143384917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.8856|TWO_SIDED|95.0|0.71|1.48|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||1.48|0.71|0.8856
71932211|NCT01236053|143384917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.5078|TWO_SIDED|95.0|0.61|1.28|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.28|0.61|0.5078
71932212|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.6888|TWO_SIDED|95.0|0.36|1.95|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||1.95|0.36|0.6888
71932213|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.5024|TWO_SIDED|95.0|0.32|1.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.75|0.32|0.5024
71932214|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6164|TWO_SIDED|95.0|0.49|1.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.53|0.49|0.6164
71932215|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4002|TWO_SIDED|95.0|0.44|1.39|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.39|0.44|0.4002
71932216|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.7329|TWO_SIDED|95.0|0.25|2.66|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.66|0.25|0.7329
71932217|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.71||||0.5731|TWO_SIDED|95.0|0.22|2.33|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.33|0.22|0.5731
71932218|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.3762|TWO_SIDED|95.0|0.69|2.63|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.63|0.69|0.3762
71932219|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.582|TWO_SIDED|95.0|0.62|2.36|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.36|0.62|0.5820
71932220|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4782|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4782
71932221|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8998|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8998
71932222|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9308|TWO_SIDED|95.0|0.53|1.99|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.99|0.53|0.9308
71932223|NCT01236053|143384918|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.5125|TWO_SIDED|95.0|0.41|1.56|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.41|0.5125
71932224|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.8655|TWO_SIDED|95.0|0.37|2.33|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.33|0.37|0.8655
71932225|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.6482|TWO_SIDED|95.0|0.32|2.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.05|0.32|0.6482
71932226|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9003|TWO_SIDED|95.0|0.53|1.76|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||1.76|0.53|0.9003
71932227|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.6|TWO_SIDED|95.0|0.46|1.56|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.56|0.46|0.6000
71932228|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.567|TWO_SIDED|95.0|0.27|2.06|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.06|0.27|0.5670
71932229|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.4353|TWO_SIDED|95.0|0.24|1.85|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.24|0.4353
71932230|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.8922|TWO_SIDED|95.0|0.56|1.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.95|0.56|0.8922
71932231|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.8591|TWO_SIDED|95.0|0.5|1.77|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.77|0.50|0.8591
71932232|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4779|TWO_SIDED|95.0|0.58|3.23|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.23|0.58|0.4779
71932233|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8994|TWO_SIDED|95.0|0.44|2.52|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.52|0.44|0.8994
71932234|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.78|TWO_SIDED|95.0|0.57|2.12|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||2.12|0.57|0.7800
71932235|NCT01236053|143384919|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.6577|TWO_SIDED|95.0|0.44|1.67|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.67|0.44|0.6577
71932236|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8111|TWO_SIDED|95.0|0.48|2.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||2.59|0.48|0.8111
71932237|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9104|TWO_SIDED|95.0|0.45|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.46|0.45|0.9104
71932238|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.5592|TWO_SIDED|95.0|0.68|2.07|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.07|0.68|0.5592
71932239|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.8521|TWO_SIDED|95.0|0.6|1.85|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.85|0.60|0.8521
71932240|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.73||||0.5529|TWO_SIDED|95.0|0.26|2.04|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.04|0.26|0.5529
71932241|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.6||||0.3275|TWO_SIDED|95.0|0.21|1.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.68|0.21|0.3275
71932242|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.89||||0.73|TWO_SIDED|95.0|0.46|1.72|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||1.72|0.46|0.7300
71932243|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.4831|TWO_SIDED|95.0|0.41|1.53|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.53|0.41|0.4831
71932244|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.7693|TWO_SIDED|95.0|0.45|2.92|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||2.92|0.45|0.7693
71932245|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.8189|TWO_SIDED|95.0|0.35|2.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||2.30|0.35|0.8189
71932246|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99||||0.98|TWO_SIDED|95.0|0.5|1.98|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||1.98|0.50|0.9800
71932247|NCT01236053|143384921|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.4944|TWO_SIDED|95.0|0.39|1.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||1.58|0.39|0.4944
71932248|NCT01236053|143384922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|20.0||||0.0144|TWO_SIDED|95.0|1.81|220.5|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||220.5|1.81|0.0144
71932249|NCT01236053|143384922|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.79||||0.0743|TWO_SIDED|95.0|0.79|147.0|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||147.0|0.79|0.0743
71932250|NCT01236053|143384923|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
71932251|NCT01236053|143384923|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
71932252|NCT01236053|143384924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
71932253|NCT01236053|143384924|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
71932254|NCT01236053|143384926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.1035|TWO_SIDED|95.0|0.63|159.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||159.9|0.63|0.1035
71932255|NCT01236053|143384926|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.1||||0.3799|TWO_SIDED|95.0|0.18|95.82|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy."|||95.82|0.18|0.3799
71932256|NCT01236053|143384927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01||||0.0066|TWO_SIDED|95.0|1.21|3.32|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.32|1.21|0.0066
71932257|NCT01236053|143384927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.0494|TWO_SIDED|95.0|1.0|2.82|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.82|1.00|0.0494
71932258|NCT01236053|143384927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.0006|TWO_SIDED|95.0|1.33|2.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.82|1.33|0.0006
71932259|NCT01236053|143384927|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.0138|TWO_SIDED|95.0|1.11|2.41|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.41|1.11|0.0138
71932260|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29||||0.0006|TWO_SIDED|95.0|1.66|6.53|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.53|1.66|0.0006
71932261|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.002|TWO_SIDED|95.0|1.5|6.05|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.05|1.50|0.0020
71932262|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.49||||0.0013|TWO_SIDED|95.0|1.43|4.34|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.34|1.43|0.0013
71932263|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.008|TWO_SIDED|95.0|1.22|3.8|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.80|1.22|0.0080
71932264|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.8165|TWO_SIDED|95.0|0.2|3.61|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||3.61|0.20|0.8165
71932265|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.6624|TWO_SIDED|95.0|0.17|3.12|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.12|0.17|0.6624
71932266|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6316|TWO_SIDED|95.0|0.45|3.68|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.68|0.45|0.6316
71932267|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.906|TWO_SIDED|95.0|0.35|3.22|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.22|0.35|0.9060
71932268|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.3731|TWO_SIDED|95.0|0.61|3.74|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.74|0.61|0.3731
71932269|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.8266|TWO_SIDED|95.0|0.43|2.87|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.87|0.43|0.8266
71932270|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0712|TWO_SIDED|95.0|0.95|3.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.13|0.95|0.0712
71932271|NCT01236053|143384928|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.2674|TWO_SIDED|95.0|0.77|2.6|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.60|0.77|0.2674
71932272|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.61||||0.0005|TWO_SIDED|95.0|1.75|7.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.46|1.75|0.0005
71932273|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.25||||0.0019|TWO_SIDED|95.0|1.55|6.83|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||6.83|1.55|0.0019
71932274|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.51||||0.0024|TWO_SIDED|95.0|1.39|4.55|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.55|1.39|0.0024
71932275|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18||||0.0115|TWO_SIDED|95.0|1.19|4.0|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.00|1.19|0.0115
71932276|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.6281|TWO_SIDED|95.0|0.17|2.96|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||2.96|0.17|0.6281
71932277|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.61||||0.5103|TWO_SIDED|95.0|0.14|2.62|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.62|0.14|0.5103
71932278|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Unadjusted Odds Ratio|1.15||||0.7733|TWO_SIDED|95.0|0.45|2.9|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.90|0.45|0.7733
71932279|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.837|TWO_SIDED|95.0|0.43|2.81|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.81|0.43|0.8370
71932280|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.75||||0.198|TWO_SIDED|95.0|0.75|4.1|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.10|0.75|0.1980
71932281|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5391|TWO_SIDED|95.0|0.54|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.21|0.54|0.5391
71932282|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.97||||0.0224|TWO_SIDED|95.0|1.1|3.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.53|1.10|0.0224
71932283|NCT01236053|143384929|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51||||0.1815|TWO_SIDED|95.0|0.82|2.77|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.77|0.82|0.1815
71932284|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.0248|TWO_SIDED|95.0|1.12|5.09|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.09|1.12|0.0248
71932285|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.16||||0.052|TWO_SIDED|95.0|0.99|4.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||4.70|0.99|0.0520
71932286|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.33||||0.0046|TWO_SIDED|95.0|1.3|4.2|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||4.20|1.30|0.0046
71932287|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05||||0.0193|TWO_SIDED|95.0|1.12|3.72|||Wilcoxon (Mann-Whitney)||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.72|1.12|0.0193
71932288|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.75||||0.0309|TWO_SIDED|95.0|1.1|6.88|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||6.88|1.10|0.0309
71932289|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.11||||0.1285|TWO_SIDED|95.0|0.81|5.51|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||5.51|0.81|0.1285
71932290|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.1257|TWO_SIDED|95.0|0.85|3.83|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.83|0.85|0.1257
71932291|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.52||||0.2944|TWO_SIDED|95.0|0.7|3.31|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||3.31|0.70|0.2944
71932292|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.21||||0.7032|TWO_SIDED|95.0|0.45|3.21|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||3.21|0.45|0.7032
71932293|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.9922|TWO_SIDED|95.0|0.37|2.69|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.69|0.37|0.9922
71932294|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.1227|TWO_SIDED|95.0|0.87|3.16|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.16|0.87|0.1227
71932295|NCT01236053|143384931|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.3809|TWO_SIDED|95.0|0.69|2.61|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis."|||2.61|0.69|0.3809
71932296|NCT01236053|143384932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.1757|TWO_SIDED|95.0|0.8|3.34|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag)."|||3.34|0.80|0.1757
71932297|NCT01236053|143384932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.4405|TWO_SIDED|95.0|0.64|2.75|||Conditional Logistic Regression||"Comparison: Ever (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.75|0.64|0.4405
71932298|NCT01236053|143384932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.24||||0.442|TWO_SIDED|95.0|0.71|2.16|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag)."|||2.16|0.71|0.4420
71932299|NCT01236053|143384932|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.9034|TWO_SIDED|95.0|0.59|1.82|||Conditional Logistic Regression||"Comparison: Ever (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.82|0.59|0.9034
71932300|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.91||||0.2395|TWO_SIDED|95.0|0.65|5.6|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||5.60|0.65|0.2395
71932301|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.3764|TWO_SIDED|95.0|0.55|4.93|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.93|0.55|0.3764
71932302|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.7599|TWO_SIDED|95.0|0.48|2.71|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||2.71|0.48|0.7599
71932303|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.9502|TWO_SIDED|95.0|0.43|2.46|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.43|0.9502
71932304|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.31||||0.7164|TWO_SIDED|95.0|0.3|5.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||5.75|0.30|0.7164
71932305|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9345|TWO_SIDED|95.0|0.24|4.73|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.73|0.24|0.9345
71932306|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.8833|TWO_SIDED|95.0|0.28|3.02|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||3.02|0.28|0.8833
71932307|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.74||||0.6178|TWO_SIDED|95.0|0.22|2.46|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.46|0.22|0.6178
71932308|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.6||||0.4556|TWO_SIDED|95.0|0.46|5.53|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||5.53|0.46|0.4556
71932309|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.7478|TWO_SIDED|95.0|0.35|4.29|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.29|0.35|0.7478
71932310|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.71||||0.235|TWO_SIDED|95.0|0.71|4.13|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.13|0.71|0.2350
71932311|NCT01236053|143384933|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.5428|TWO_SIDED|95.0|0.54|3.24|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.24|0.54|0.5428
71690719|NCT02651337|142897632|OTHER|It is a one arm clinical study. No comparison between groups was made.|||||||||||||||||The study tested the hypothesis that the Alivio flusher could increase flow in occluded or sluggish flowing catheters. Analysis was made on the basis of the procedural results related to priming the flusher, connecting the flusher to the shunt, flushing the system by dome compression, the ability to refill the dome, and the ability to evacuate the dome.|||
71932312|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.9||||0.3123|TWO_SIDED|95.0|0.55|6.59|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||6.59|0.55|0.3123
71932313|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.3951|TWO_SIDED|95.0|0.49|6.15|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||6.15|0.49|0.3951
71932314|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.4388|TWO_SIDED|95.0|0.56|3.75|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.75|0.56|0.4388
71932315|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.5535|TWO_SIDED|95.0|0.51|3.47|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.47|0.51|0.5535
71932316|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.6332|TWO_SIDED|95.0|0.4|4.48|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.48|0.40|0.6332
71932317|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.1||||0.8743|TWO_SIDED|95.0|0.32|3.75|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.75|0.32|0.8743
71932318|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.6132|TWO_SIDED|95.0|0.27|2.15|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.15|0.27|0.6132
71932319|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Adjusted Odds Ratio|0.63||||0.3821|TWO_SIDED|95.0|0.22|1.78|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||1.78|0.22|0.3821
71932320|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.8||||0.3591|TWO_SIDED|95.0|0.51|6.28|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||6.28|0.51|0.3591
71932321|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29||||0.6899|TWO_SIDED|95.0|0.37|4.58|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||4.58|0.37|0.6899
71932322|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.2031|TWO_SIDED|95.0|0.73|4.3|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||4.30|0.73|0.2031
71932323|NCT01236053|143384934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.4932|TWO_SIDED|95.0|0.56|3.37|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.37|0.56|0.4932
71932324|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.64||||0.0843|TWO_SIDED|95.0|0.88|7.96|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag)."|||7.96|0.88|0.0843
71932325|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.71||||0.081|TWO_SIDED|95.0|0.88|8.28|||Conditional Logistic Regression||"Comparison: Tertile 1 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||8.28|0.88|0.0810
71932326|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4583|TWO_SIDED|95.0|0.55|3.7|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag)."|||3.70|0.55|0.4583
71932327|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.43||||0.4622|TWO_SIDED|95.0|0.55|3.73|||Conditional Logistic Regression||"Comparison: Tertile 1 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.73|0.55|0.4622
71932328|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45||||0.5512|TWO_SIDED|95.0|0.43|4.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag)."|||4.95|0.43|0.5512
71932329|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.06||||0.9277|TWO_SIDED|95.0|0.31|3.67|||Conditional Logistic Regression||"Comparison: Tertile 2 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.67|0.31|0.9277
71932330|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23||||0.6402|TWO_SIDED|95.0|0.51|2.95|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag)."|||2.95|0.51|0.6402
71932331|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.9256|TWO_SIDED|95.0|0.4|2.32|||Conditional Logistic Regression||"Comparison: Tertile 2 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.32|0.40|0.9256
71690720|NCT00869128|142897633|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANOVA|The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||||0.04
71690721|NCT02716584|142897667|SUPERIORITY||Effect size|0.41||||0.02|TWO_SIDED||||||ANCOVA|||Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of exercise sessions attended as a covariate.||||0.02
71932332|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.9514|TWO_SIDED|95.0|0.24|4.5|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag)."|||4.50|0.24|0.9514
71690722|NCT02716584|142897668|SUPERIORITY||Effect size|0.35||||0.06|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.06
71690723|NCT02716584|142897669|SUPERIORITY|||||||0.13|||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.13
71690724|NCT02716584|142897670|SUPERIORITY||Effect size|0.19||||0.73|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.73
71932333|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.7543|TWO_SIDED|95.0|0.18|3.44|||Conditional Logistic Regression||"Comparison: Tertile 3 (with 2 year lag) and Never (with 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||3.44|0.18|0.7543
71932334|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.8781|TWO_SIDED|95.0|0.38|3.07|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag)."|||3.07|0.38|0.8781
71932335|NCT01236053|143384936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.7429|TWO_SIDED|95.0|0.29|2.4|||Conditional Logistic Regression||"Comparison: Tertile 3 (without 2 year lag) and Never (without 2 year lag). Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use."|||2.40|0.29|0.7429
71932336|NCT02340078|143384938|SUPERIORITY||Subjects % with difference in VAS ≥ 10mm|0.9516|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
71932337|NCT01311505|143384939|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.9|||||TWO_SIDED|90.0|92.98|105.2||||||20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||105.20|92.98|
71932338|NCT01311505|143384940|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|98.24|||||TWO_SIDED|90.0|87.77|109.97||||||20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.||109.97|87.77|
71932339|NCT01311505|143384942|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|100.25|||||TWO_SIDED|90.0|94.44|106.41||||||Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.||106.41|94.44|
71932340|NCT00883129|143384977|SUPERIORITY_OR_OTHER|||||||0.24||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the FVC %-predicted. Covariates were %-predicted FVC, HRCT-defined extent of lung fibrosis in the lobe of maximum involvement, and terms for time-trend, treatment and treatment-time trend interactions.||||0.24
71932341|NCT00883129|143384977|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the FVC %-predicted for each treatment arm independently.||||<0.05
71690725|NCT02716584|142897670|SUPERIORITY||Effect size|0.73||||0.33|TWO_SIDED|||||For cohort 3, positive affect was measured at baseline and a midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.33
71690726|NCT02716584|142897671|SUPERIORITY||Effect size|-0.21||||0.62|TWO_SIDED|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.62
71690727|NCT02716584|142897671|SUPERIORITY||Effect size|0.77||||0.23|TWO_SIDED|||||For cohort 3, positive affect was measured at a baseline and midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||.23
71690728|NCT02716584|142897672|SUPERIORITY||Effect size|0.02||||0.57|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.57
71690729|NCT02716584|142897673|SUPERIORITY||Effect size|0.35||||0.12|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.12
71690730|NCT02716584|142897674|SUPERIORITY||Effect size|0.72||||0.07|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.07
71932342|NCT00883129|143384977|SUPERIORITY_OR_OTHER|||||||0.55||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of FVC %-predicted at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the FVC %-predicted.||||0.55
71932343|NCT00883129|143384978|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the TLC %-predicted.||||>0.05
71690731|NCT02716584|142897675|SUPERIORITY||Effect size|0.0||||0.88|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.88
71690732|NCT02716584|142897676|SUPERIORITY||Effect size|0.05||||0.86|TWO_SIDED||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.||||||0.86
71690733|NCT02497937|142897709|OTHER||Mean Difference (Net)|0.793|||||TWO_SIDED|95.0|-0.925|2.512|||||Difference estimate of DLco on Day 7 has been presented for Mayo site|||2.512|-0.925|
71690734|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-1.4|||||TWO_SIDED|95.0|-4.4|1.3||||||Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.||1.3|-4.4|
71690735|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.2|0.1||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.1|-6.2|
71690736|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
71690737|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-5.0|||||TWO_SIDED|95.0|-9.6|-0.9||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.9|-9.6|
71690738|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.1|||||TWO_SIDED|95.0|-13.0|-4.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-4.0|-13.0|
71690739|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-8.6|||||TWO_SIDED|95.0|-14.0|-3.7||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-3.7|-14.0|
71690740|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-3.2|||||TWO_SIDED|95.0|-6.8|-0.3||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-0.3|-6.8|
71690741|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.7|||||TWO_SIDED|95.0|-6.4|0.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.4|-6.4|
71690742|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-0.9|||||TWO_SIDED|95.0|-4.4|2.4||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.4|-4.4|
71690743|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-2.3|||||TWO_SIDED|95.0|-5.6|0.5||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||0.5|-5.6|
71690744|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.1|
71690745|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.7|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.7|
71690746|NCT04530838|142897763|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.|Percentage Difference|-4.0|||||TWO_SIDED|95.0|-9.5|1.2||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.2|-9.5|
71690747|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.9|||||TWO_SIDED|95.0|3.0|10.0||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|3.0|
71761101|NCT00494676|143023809|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6|STANDARD_DEVIATION|2.6|=|0.09|TWO_SIDED|95.0|-0.1|1.3|||t-test, 2 sided|||Mobility improvement scores were normally distributed. A paired t-test was used to conduct a within-subjects comparison of the crossover differences in mobility scores between real and sham prism glasses. An alpha level of 5% was used to indicate statistical significance for secondary analyses||1.3|-0.1|= 0.09
71932344|NCT00883129|143384979|SUPERIORITY_OR_OTHER||||||<|0.001||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the DLCO %-predicted.||||<0.001
71932345|NCT00883129|143384979|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the DLCO %-predicted for each treatment arm independently.||||>0.05
71932346|NCT00883129|143384980|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the Quantitative Lung Fibrosis Score for the whole lung (QLF-WL).||||>0.05
71932347|NCT00883129|143384981|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in dyspnea as measured by the Transitional Dyspnea Index Score.||||>0.05
71932348|NCT00883129|143384981|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for dyspnea using the Transitional Dyspnea Index Score for each treatment arm independently.||||<0.05
71932349|NCT00883129|143384983|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in modified Rodnan Skin Score (mRSS).||||>0.05
71932350|NCT00883129|143384983|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the modified Rodnan Skin Score for each treatment arm independently.||||<0.05
71932351|NCT00883129|143384983|SUPERIORITY_OR_OTHER||||||>|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|||Based on the absolute difference between the value of the mRSS at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the mRSS.||||>0.05
71932352|NCT00883129|143384984|SUPERIORITY_OR_OTHER||||||<|0.05||||||The threshold for statistical significance was a P-Value of \</=0.05.|Fisher Exact|The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.||Fisher's Exact Test was utilized to compare the number of participants with a protocol-defined adverse event of interest, SAE or death between the MMF and CYC treatment arms.||||<0.05
71932353|NCT00883129|143384985|SUPERIORITY_OR_OTHER|||||||0.019||||||The threshold for statistical significance was a P-Value of \</=0.05.|Log Rank|||A log-rank test was utilized to assess differences between the MMF and CYC treatment arms with respect to the time to withdrawal from study drug or meeting protocol-defined criteria for treatment failure.||||0.019
71932354|NCT03273257|143384986|SUPERIORITY|||||||0.139|||||||2-sample Wilcoxon rank sum test|||The null hypothesis is that there is no difference between the treatment groups in percent change from baseline in PVR immediately before PEA.||||0.139
71932355|NCT00500656|143385012|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|3.475|||<|0.001|TWO_SIDED|95.0|1.901|6.355|||The Wilcoxon version of the log rank|The median time to onset was calculated using Kaplan Meier methodology. The Wilcoxon version of the log rank test of SAS was used||||6.355|1.901|< 0.001
71932356|NCT00500656|143385013|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||The Wilcoxon version of the log rank|The median time to almost complete symptom relief was calculated using Kaplan Meier methodology.The Wilcoxon version of the log rank test SAS was used||||||< 0.001
71932357|NCT01211613|143385014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|14.0||0.009|TWO_SIDED|95.0||||The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.||||||0.009
71932358|NCT01211613|143385015|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p \< 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.||||||0.002
71932359|NCT03853213|143385016|SUPERIORITY||Mean difference (in change score)|2.54||||0.698|TWO_SIDED|95.0|-11.62|16.71|||t-test, 2 sided|The p-value is adjusted using the Satterthwaite correction due to unequal variances between the two groups.|A higher value of the estimation parameter of mean difference in change score indicates a greater reduction in the measure for the intervention group relative to the attention control group.|||16.71|-11.62|0.698
71932360|NCT03853213|143385017|SUPERIORITY||Mean Difference (Final Values)|-3.88||||0.123|TWO_SIDED|95.0|-9.0|1.24|||t-test, 2 sided||A lower value of the estimation parameter of mean difference indicates lower extent of medication nonadherence for the intervention relative to the control group.|Note that the measure of extent of medication nonadherence used the older 5-item version of the scale rather than the newer 3-item version of the scale because the IRB modification to change the measure took effect after the majority of participants who provided data for Visit 2 had completed the measure.||1.24|-9.00|0.123
71932361|NCT03853213|143385018|SUPERIORITY||Mean difference (in change score)|66.29||||0.965|TWO_SIDED|95.0|-3081.7|3214.3|||t-test, 2 sided|||||3214.3|-3081.7|0.965
71932362|NCT03853213|143385019|SUPERIORITY||Mean difference (in change score)|-6.17||||0.29|TWO_SIDED|95.0|-18.15|5.81|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in context sensitivity for the intervention group relative to the attention control group.|||5.81|-18.15|0.290
71761102|NCT00494676|143023810|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.7|=|0.002|TWO_SIDED|95.0|0.7|3.0|||t-test, 2 sided|||||3.0|0.7|= 0.002
71932363|NCT03853213|143385020|SUPERIORITY||Mean difference (in change score)|-5.07||||0.434|TWO_SIDED|95.0|-18.51|8.38|||t-test, 2 sided||A higher value of the estimation parameter of mean difference in change score indicates a greater increase in future time perspective for the intervention group relative to the attention control group.|||8.38|-18.51|0.434
71932364|NCT03853213|143385021|SUPERIORITY||Mean Difference (Final Values)|17.05||||0.293|TWO_SIDED|95.0|-19.07|53.17|||t-test, 2 sided||A higher value of the estimation parameter of mean difference indicates a lower extent of objectively measured medication adherence for the intervention relative to the control group.|||53.17|-19.07|0.293
71932365|NCT02239692|143385046|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-3.93|||<|0.0001|TWO_SIDED|95.0|-4.99|-2.87||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-2.87|-4.99|<0.0001
71932366|NCT02239692|143385047|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-4.38|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.41||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||-3.41|-5.34|<0.0001
71932367|NCT02239692|143385048|SUPERIORITY_OR_OTHER||Adjusted estimated odds ratio|9.18|||<|0.0001|TWO_SIDED|95.0|4.36|19.32||p-value corresponds to a two-sided test of superiority.|Regression, Logistic|Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.|The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.||19.32|4.36|<0.0001
71932368|NCT00297492|143385052|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||Statistical significance was determined by a two-sided p value less than 0.05.|Chi-squared|Degrees of freedom = 2||"Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05."||||0.30
71932369|NCT00297492|143385052|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59|||||TWO_SIDED|95.0|0.28|1.22|||||The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.|||1.22|0.28|
71932370|NCT02625207|143385067|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.73||||0.1318|TWO_SIDED|90.0|98.55|138.26|||Mixed Models Analysis|||||138.26|98.55|0.1318
71761103|NCT00494676|143023811|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5|STANDARD_DEVIATION|2.1|=|0.21|TWO_SIDED|95.0|-1.2|0.3|||t-test, 2 sided|||||0.3|-1.2|= 0.21
71932371|NCT02625207|143385067|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.85||||0.1369|TWO_SIDED|90.0|72.48|101.68|||Mixed Models Analysis|||||101.68|72.48|0.1369
71932372|NCT02625207|143385067|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.38|||<|0.0001|TWO_SIDED|90.0|53.51|75.07|||Mixed Models Analysis|||||75.07|53.51|< 0.0001
71932373|NCT02625207|143385067|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.83||||0.0036|TWO_SIDED|90.0|62.57|87.13|||Mixed Models Analysis|||||87.13|62.57|0.0036
71932374|NCT02625207|143385067|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.99||||0.0038|TWO_SIDED|90.0|62.7|87.31|||Mixed Models Analysis|||||87.31|62.70|0.0038
71932375|NCT02625207|143385068|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.59||||0.0531|TWO_SIDED|90.0|70.33|96.98|||Mixed Models Analysis|||||96.98|70.33|0.0531
71932376|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|137.07||||0.0106|TWO_SIDED|90.0|112.4|167.15|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||167.15|112.40|0.0106
71932377|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|164.06||||0.0001|TWO_SIDED|90.0|134.54|200.06|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||200.06|134.54|0.0001
71932378|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|198.49|||<|0.0001|TWO_SIDED|90.0|162.77|242.05|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||242.05|162.77|< 0.0001
71932379|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|120.99||||0.1061|TWO_SIDED|90.0|99.65|146.9|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||146.90|99.65|0.1061
71932380|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|272.07|||<|0.0001|TWO_SIDED|90.0|224.08|330.33|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.||330.33|224.08|<0.0001
71932381|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|110.22||||0.3081|TWO_SIDED|90.0|94.05|129.18|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||129.18|94.05|0.3081
71932382|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.71||||0.8583|TWO_SIDED|90.0|86.79|119.2|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||119.20|86.79|0.8583
71932383|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|108.52||||0.3913|TWO_SIDED|90.0|92.6|127.17|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||127.17|92.60|0.3913
71932384|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|106.69||||0.4866|TWO_SIDED|90.0|91.36|124.6|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||124.60|91.36|0.4866
71932385|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|119.61||||0.059|TWO_SIDED|90.0|102.42|139.69|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.||139.69|102.42|0.0590
71932386|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.7||||0.9816|TWO_SIDED|90.0|80.47|123.53|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||123.53|80.47|0.9816
71932387|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.12||||0.6974|TWO_SIDED|90.0|84.84|130.24|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||130.24|84.84|0.6974
71932388|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|101.03||||0.9363|TWO_SIDED|90.0|81.54|125.18|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||125.18|81.54|0.9363
71932389|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|96.11||||0.752|TWO_SIDED|90.0|77.94|118.52|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||118.52|77.94|0.7520
71932390|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|100.73||||0.9536|TWO_SIDED|90.0|81.69|124.22|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.||124.22|81.69|0.9536
71690748|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-33.5|||||TWO_SIDED|95.0|-40.7|-26.2||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-26.2|-40.7|
71932391|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.6||||0.8241|TWO_SIDED|90.0|81.28|117.18|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||117.18|81.28|0.8241
71932392|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.5||||0.1261|TWO_SIDED|90.0|98.69|142.28|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||142.28|98.69|0.1261
71932393|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.6||||0.9708|TWO_SIDED|90.0|82.95|119.59|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||119.59|82.95|0.9708
71932394|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|84.05||||0.1099|TWO_SIDED|90.0|70.29|100.52|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||100.52|70.29|0.1099
71932395|NCT02625207|143385069|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|97.21||||0.7913|TWO_SIDED|90.0|81.29|116.25|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.||116.25|81.29|0.7913
71932396|NCT02625207|143385070|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|116.65||||0.1338|TWO_SIDED|90.0|98.47|138.18|||Mixed Models Analysis|||||138.18|98.47|0.1338
71932397|NCT02625207|143385070|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|85.84||||0.137|TWO_SIDED|90.0|72.46|101.68|||Mixed Models Analysis|||||101.68|72.46|0.1370
71932398|NCT02625207|143385070|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|63.34|||<|0.0001|TWO_SIDED|90.0|53.47|75.04|||Mixed Models Analysis|||||75.04|53.47|< 0.0001
71932399|NCT02625207|143385070|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean ratio|73.79||||0.0036|TWO_SIDED|90.0|62.53|87.09|||Mixed Models Analysis|||||87.09|62.53|0.0036
71932400|NCT02625207|143385070|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|73.89||||0.0037|TWO_SIDED|90.0|62.61|87.2|||Mixed Models Analysis|||||87.20|62.61|0.0037
71932401|NCT02625207|143385071|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|82.42||||0.0507|TWO_SIDED|90.0|70.2|96.77|||Mixed Models Analysis|||||96.77|70.20|0.0507
71932402|NCT02625207|143385072|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|118.19||||0.1997|TWO_SIDED|90.0|95.26|146.63|||Mixed Models Analysis|||||146.63|95.26|0.1997
71932403|NCT02625207|143385072|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|87.28||||0.2947|TWO_SIDED|90.0|70.34|108.28|||Mixed Models Analysis|||||108.28|70.34|0.2947
71932404|NCT02625207|143385072|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|61.23||||0.0004|TWO_SIDED|90.0|49.35|75.97|||Mixed Models Analysis|||||75.97|49.35|0.0004
71932405|NCT02625207|143385072|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|70.16||||0.0071|TWO_SIDED|90.0|56.81|86.63|||Mixed Models Analysis|||||86.63|56.81|0.0071
71932406|NCT02625207|143385072|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|72.37||||0.0135|TWO_SIDED|90.0|58.6|89.36|||Mixed Models Analysis|||||89.36|58.60|0.0135
71932407|NCT02625207|143385073|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|68.32||||0.0505|TWO_SIDED|90.0|49.81|93.71|||Mixed Models Analysis|||||93.71|49.81|0.0505
71932408|NCT02625207|143385074|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|94.83||||0.6761|TWO_SIDED|90.0|76.7|117.24|||Mixed Models Analysis|||||117.24|76.70|0.6761
71932409|NCT02625207|143385074|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|105.43||||0.6771||90.0|85.28|130.35|||Mixed Models Analysis|||||130.35|85.28|0.6771
71932410|NCT02625207|143385074|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|75.74||||0.0331|TWO_SIDED|90.0|61.26|93.64|||Mixed Models Analysis|||||93.64|61.26|0.0331
71932411|NCT02625207|143385074|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.84||||0.0104|TWO_SIDED|90.0|58.38|88.4|||Mixed Models Analysis|||||88.40|58.38|0.0104
71932412|NCT02625207|143385074|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|71.82||||0.0104|TWO_SIDED|90.0|58.37|88.39|||Mixed Models Analysis|||||88.39|58.37|0.0104
71932413|NCT02625207|143385075|SUPERIORITY_OR_OTHER||Adjusted Geometric Mean Ratio|99.62||||0.9713|TWO_SIDED|90.0|83.07|119.45|||Mixed Models Analysis|||||119.45|83.07|0.9713
71932414|NCT00802529|143385102|SUPERIORITY_OR_OTHER|||||||0.271||||||P-value for Drug x Time interaction.|ANOVA|Time: 2 degrees of freedom (Baseline vs 18-24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.271
71690749|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
71690750|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|-19.0|||||TWO_SIDED|95.0|-25.7|-12.5||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-12.5|-25.7|
71690751|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|5.5|||||TWO_SIDED|95.0|2.2|9.6||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||9.6|2.2|
71690752|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|6.4|||||TWO_SIDED|95.0|3.8|10.4||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.4|3.8|
71690753|NCT04530838|142897763|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC \[SC\] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.|Percentage Difference|1.3|||||TWO_SIDED|95.0|-3.2|6.0||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||6.0|-3.2|
71690754|NCT04530838|142897763|OTHER||Percentage Difference|-5.7|||||TWO_SIDED|95.0|-10.4|-1.7||||||Serotype 1: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||-1.7|-10.4|
71932415|NCT00802529|143385103|SUPERIORITY_OR_OTHER|||||||0.964||||||P-value for Drug x Time interaction.|ANOVA|Time: 6 degrees of freedom (Baseline, 1, 2, 6, 12, 18 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.964
71932416|NCT00802529|143385104|SUPERIORITY_OR_OTHER|||||||0.128||||||P-value for Drug x Time interaction.|ANOVA|Time: 5 degrees of freedom (Baseline, 1, 2, 6, 12 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)||||||0.128
71932417|NCT00563524|143385127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5237|||||||ANCOVA|||Baseline: Analysis of covariance (ANCOVA) with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.5237
71932418|NCT00563524|143385127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8463|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.8463
71932419|NCT00563524|143385127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4596|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4596
71932420|NCT00563524|143385127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6345|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6345
71932421|NCT00563524|143385127|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6235|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.6235
71932422|NCT00563524|143385128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3833|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.3833
71932423|NCT00563524|143385128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4909|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4909
71932424|NCT00563524|143385128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.2200
71932425|NCT00563524|143385128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4183|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4183
71690755|NCT04530838|142897763|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.2|2.9||||||Serotype 3: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.9|-5.2|
71690756|NCT04530838|142897763|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 4: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
71690757|NCT04530838|142897763|OTHER||Percentage Difference|0.7|||||TWO_SIDED|95.0|-4.5|5.8||||||Serotype 5: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.8|-4.5|
71690758|NCT04530838|142897763|OTHER||Percentage Difference|4.8|||||TWO_SIDED|95.0|-0.2|10.0||||||Serotype 6A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||10.0|-0.2|
71690759|NCT04530838|142897763|OTHER||Percentage Difference|-5.6|||||TWO_SIDED|95.0|-12.5|1.1||||||Serotype 6B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.1|-12.5|
71690760|NCT04530838|142897763|OTHER||Percentage Difference|-1.1|||||TWO_SIDED|95.0|-5.4|3.1||||||Serotype 7F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.1|-5.4|
71690761|NCT04530838|142897763|OTHER||Percentage Difference|-3.0|||||TWO_SIDED|95.0|-7.7|1.4||||||Serotype 9V: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.4|-7.7|
71690762|NCT04530838|142897763|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-4.4|3.2||||||Serotype 14: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||3.2|-4.4|
71690763|NCT04530838|142897763|OTHER||Percentage Difference|-2.0|||||TWO_SIDED|95.0|-6.2|1.9||||||Serotype 18C: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.9|-6.2|
71690764|NCT04530838|142897763|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.0|1.7||||||Serotype 19A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-3.0|
71690765|NCT04530838|142897763|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 19F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
71690766|NCT04530838|142897763|OTHER||Percentage Difference|-0.9|||||TWO_SIDED|95.0|-6.9|5.1||||||Serotype 23F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||5.1|-6.9|
71690767|NCT04530838|142897763|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-2.2|2.1||||||Serotype 8: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.1|-2.2|
71690768|NCT04530838|142897763|OTHER||Percentage Difference|-0.6|||||TWO_SIDED|95.0|-9.8|8.6||||||Serotype 10A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.6|-9.8|
71690769|NCT04530838|142897763|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 11A: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
71690770|NCT04530838|142897763|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-8.2|8.2||||||Serotype 12F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||8.2|-8.2|
71690771|NCT04530838|142897763|OTHER||Percentage Difference|-0.5|||||TWO_SIDED|95.0|-3.3|2.0||||||Serotype 15B: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.0|-3.3|
71690772|NCT04530838|142897763|OTHER||Percentage Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||Serotype 22F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||1.7|-1.8|
71690773|NCT04530838|142897763|OTHER||Percentage Difference|-2.5|||||TWO_SIDED|95.0|-7.5|2.2||||||Serotype 33F: 2-Sided 95% CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.||2.2|-7.5|
71690774|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.62|||||TWO_SIDED|95.0|0.54|0.72||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.72|0.54|
71690775|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.71|||||TWO_SIDED|95.0|0.63|0.81||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.81|0.63|
71690776|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.51|0.7||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.51|
71690777|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.49|0.71||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.71|0.49|
71761104|NCT02873702|143023877|NON_INFERIORITY|Non-inferiority to lansoprazole if the lower bound of confidence interval (CI) for the treatment difference is greater than -10%.|Difference in Percentage|-2.65|||||TWO_SIDED|95.0|-26.59|21.3||||||Healing Period: Dexlansoprazole 60 mg versus Healing Period: Lansoprazole 30 mg||21.30|-26.59|
71761105|NCT01039376|143023885|SUPERIORITY||Hazard Ratio (HR)|0.55|||<|0.0001|TWO_SIDED|95.0|0.43|0.7|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.70|0.43|<0.0001
71932426|NCT00563524|143385128|SUPERIORITY_OR_OTHER_LEGACY|||||||0.465|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.4650
71761106|NCT01039376|143023886|SUPERIORITY||Hazard Ratio (HR)|0.54|||<|0.0001|TWO_SIDED|95.0|0.42|0.68|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.68|0.42|<0.0001
71932427|NCT00563524|143385129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7051|||||||ANCOVA|||Baseline: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.7051
71932428|NCT00563524|143385129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1072|||||||ANCOVA|||Day 14: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.1072
71932429|NCT00563524|143385129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||ANCOVA|||Day 28: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0020
71932430|NCT00563524|143385129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0079|||||||ANCOVA|||Day 42: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0079
71932431|NCT00563524|143385129|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0308|||||||ANCOVA|||Day 56: ANCOVA with pre-dose as the baseline covariate and treatment as a factor was used for the analysis.||||0.0308
71932432|NCT03231709|143385182|OTHER|||||||0.0141|||||||Mainland-Gart Test|||||||0.0141
71932433|NCT01875991|143385192|SUPERIORITY_OR_OTHER|||||||0.501|||||||Van Elteren test|P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)||||||0.501
71932434|NCT04991311|143385237|SUPERIORITY||Mean Difference (Final Values)|398.4|STANDARD_DEVIATION|581.6|=|0.0585|TWO_SIDED|95.0|-17.6|814.4|||Paired t-test (2-sided, alpha=0.05)|||The participants in both comparison groups are the same.||814.4|-17.6|= 0.0585
71932435|NCT00755937|143385264|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|66.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71932436|NCT00755937|143385265|SUPERIORITY_OR_OTHER||percentage (no inferential test)|72.5||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71932437|NCT00755937|143385266|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71932438|NCT00755937|143385267|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|60.3||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71932439|NCT00755937|143385268|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|64.8||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71932440|NCT00755937|143385269|SUPERIORITY_OR_OTHER||Percentage (no inferential test)|72.1||||||||||There were no comparisons between groups as this was a single-arm observational study.||||||||
71932441|NCT01676311|143385271|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group, CVLT-II-total learning score at baseline and week 12, and covariates (Beck Depression Index \[BDI\], time post-injury, British Columbia Postconcussion Symptom Inventory \[BC-PSI\]). Regression analyses were repeated, permuting data observations for each outcome. The BDI and BC-PSI are covariates in the regression model and not pre-specified Primary and Secondary Outcome Measures.||||0.38
71932442|NCT01676311|143385271|SUPERIORITY|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-short delay free recall (SDFR) score, outcome (CVLT-II-SDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.38
71761107|NCT01039376|143023887|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.6046|TWO_SIDED|95.0|0.69|1.25|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.25|0.69|0.6046
71932443|NCT01676311|143385271|SUPERIORITY|||||||0.42||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-long delay free recall (LDFR) score, outcome (CVLT-II-LDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.||||0.42
71932444|NCT01676311|143385274|SUPERIORITY|||||||0.48||||||A chi-square test with factors of group (Huperzine A, placebo) and occurrence of seizure (yes, no) was performed. A permutation test was the used to assess the effect of Huperzine A on the prevalence of seizures.|Chi-squared test and permutation test|||||||0.48
71932445|NCT01676311|143385275|SUPERIORITY|||||||0.44||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of behavioral side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of behavioral side effects.|Chi-squared test and permutation test|||Behavioral side effects statistical analysis||||0.44
71932446|NCT01676311|143385275|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of cardiac-respiratory side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Cardiac-respiratory side effects statistical analysis||||0.81
71932447|NCT01676311|143385275|SUPERIORITY|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of dermatological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of dermatological side effects.|Chi-squared test and permutation test|||Dermatological side effects statistical analysis||||0.81
71932448|NCT01676311|143385275|SUPERIORITY|||||||0.73||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of gastrointestinal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Gastrointestinal side effects statistical analysis||||0.73
71932449|NCT01676311|143385275|SUPERIORITY|||||||0.54||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of genitourinary/neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects|Chi-squared test and permutation test|||Genitourinary/neurological side effects statistical analysis||||0.54
71932450|NCT01676311|143385275|SUPERIORITY|||||||0.27||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of hematological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Hematological side effects statistical analysis||||0.27
71761108|NCT01039376|143023889|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.0178|TWO_SIDED|95.0|0.62|0.96|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||0.96|0.62|0.0178
71932451|NCT01676311|143385275|SUPERIORITY|||||||0.41||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of musculoskeletal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Musculoskeletal side effects statistical analysis||||0.41
71932452|NCT01676311|143385275|SUPERIORITY|||||||1||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Neurological side effects statistical analysis||||1.00
71932453|NCT01347879|143385283|SUPERIORITY_OR_OTHER||Difference in least square means|-7.35||||0.006|TWO_SIDED|95.0|-12.5|-2.2|||ANCOVA|Lesion count at baseline and center as covariates||||-2.2|-12.5|0.006
71932454|NCT01347879|143385284|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6||||0.8527|TWO_SIDED|95.0|-6.6|5.5|||ANCOVA|Lesion count at baseline and center as covariates||||5.5|-6.6|0.8527
71932455|NCT01347879|143385285|SUPERIORITY_OR_OTHER||Difference in least square means|-20.0||||0.0032|TWO_SIDED|95.0|-33.2|-6.8|||ANCOVA|Lesion count at baseline and center as covariates||||-6.8|-33.2|0.0032
71932456|NCT01347879|143385286|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||Regression, Logistic|||||||0.0125
71932457|NCT01347879|143385291|SUPERIORITY_OR_OTHER||Difference in least square means|-2.56||||0.7161|TWO_SIDED|95.0|-16.5|11.3|||ANCOVA|Lesion count at baseline and center as covariate||||11.3|-16.5|0.7161
71932458|NCT01223196|143385297|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.||Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).||||0.04
71932459|NCT01223196|143385297|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.||||||0.05
71932460|NCT01223196|143385298|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.||Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
71932461|NCT01223196|143385298|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.||Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1||||<0.05
71932462|NCT01223196|143385299|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.||Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon's rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).||||<0.05
71932463|NCT00323271|143385300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.108||||0.911|TWO_SIDED|95.0|-2.106|1.888|||t-test, 2 sided|||||1.888|-2.106|.911
71932464|NCT00323271|143385301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.644||||0.32|TWO_SIDED|95.0|-1.058|2.345||Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|ANCOVA|||||2.345|-1.058|0.320
71932465|NCT00068770|143385302|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5|STANDARD_DEVIATION|1.0||0.82|TWO_SIDED|95.0|1.5|5.5||not adjusted|t-test, 2 sided|||two independent group comparisons||5.5|1.5|0.82
71932466|NCT00068770|143385303|NON_INFERIORITY_OR_EQUIVALENCE|equivalence analysis|Hazard Ratio (HR)|2.7|STANDARD_DEVIATION|1.8||0.11|TWO_SIDED|95.0|1.1|6.3|||Log Rank|||||6.3|1.1|0.11
71932467|NCT00123487|143385342|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the QD schedule relative to the BID schedule was claimed if the lower bound of the 95% CI for difference (QD - BD) was ≥ -12%.|Percent Difference|0.2|||||TWO_SIDED|95.0|-7.8|8.1||||||Primary endpoint was to be assessed at 6-Months: Assuming a 45% MaHR rate in the 70 mg BID participants, the primary efficacy analysis required a total of 540 participants, approximately 270 in each dosing schedule, giving at least 80% power to deduce non-inferiority of the QD schedule relative to the BID schedule if the lower bound of the 95% CI for the difference in MaHR rates (MaHRRQD - MaHRRBID) is greater than -12%.||8.1|-7.8|
71932468|NCT01039584|143385362|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-9.1|12.3|||Wald's method|||||12.3|-9.1|
71932469|NCT01039584|143385363|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.|Yates continuity correction|1.5|||||TWO_SIDED|90.0|-7.3|12.8|||Wald's method|||||12.8|-7.3|
71932470|NCT01039584|143385364|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure|Yates continuity correction|1.5||||0.05|TWO_SIDED|90.0|-11.7|9.4|||Wald's method|||||9.4|-11.7|0.05
71932471|NCT01791127|143385383|SUPERIORITY|The primary endpoint 1 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.|||||<|0.0001|||||||Exact, binomial|||||||<0.0001
71932472|NCT01791127|143385384|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 2 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
71932473|NCT01791127|143385385|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||The primary endpoint 3 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (successful sensing and pacing rate at 12 months) to 97.0%, with Type I error (alpha) or 0.025 and power of 80%.||||<0.0001
71932474|NCT01791127|143385386|SUPERIORITY|||||||||||||||||The primary endpoint 4 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 5 years) to 92.5%, with Type I error (alpha) or 0.025 and power of 80%.|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
71761109|NCT01039376|143023890|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.3136|TWO_SIDED|95.0|0.42|1.32|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.32|0.42|0.3136
71932475|NCT03471182|143385425|SUPERIORITY|||||||0.035||||||Primary hypothesis of a group difference (i.e., CUD vs HHC-PET participants) in mGluR5 availability was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 9 regions of interest (i.e., all 9 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of region. Group (i.e., CUD, HHC-PET) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the region-by-group interaction term and a factor to model the random-effect of participant.||||0.035
71761110|NCT01039376|143023891|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.1603|TWO_SIDED|95.0|0.29|1.19|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of \<1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.|||1.19|0.29|0.1603
71690778|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.59|||||TWO_SIDED|95.0|0.5|0.7||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.70|0.50|
71690779|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.51|||||TWO_SIDED|95.0|0.4|0.64||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.64|0.40|
71690780|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.72|||||TWO_SIDED|95.0|0.62|0.84||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.84|0.62|
71690781|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.69|||||TWO_SIDED|95.0|0.6|0.8||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.80|0.60|
71690782|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.01|0.70|
71690783|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.66|||||TWO_SIDED|95.0|0.57|0.77||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.77|0.57|
71690784|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.76|||||TWO_SIDED|95.0|0.65|0.87||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.87|0.65|
71690785|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.75|||||TWO_SIDED|95.0|0.67|0.85||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.85|0.67|
71690786|NCT04530838|142897764|NON_INFERIORITY|Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.64|||||TWO_SIDED|95.0|0.53|0.78||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.78|0.53|
71690787|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|4.01|||||TWO_SIDED|95.0|3.36|4.79||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||4.79|3.36|
71690788|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.6|||||TWO_SIDED|95.0|0.48|0.76||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.76|0.48|
71690789|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|6.8|||||TWO_SIDED|95.0|5.69|8.13||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||8.13|5.69|
71690790|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|0.95|||||TWO_SIDED|95.0|0.76|1.2||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.76|
71932476|NCT03471182|143385426|SUPERIORITY|Outcome Measure Data were tested using a single linear mixed effects model. The 4 brain networks of interest (i.e., all 4 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||||0.024||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in functional brain network engagement was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||||||0.024
71690791|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|8.18|||||TWO_SIDED|95.0|6.75|9.92||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||9.92|6.75|
71690792|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|5.97|||||TWO_SIDED|95.0|5.0|7.12||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||7.12|5.00|
71690793|NCT04530838|142897764|NON_INFERIORITY|For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC \[SC\] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC \[SC\]/lowest 13vPnC \[SC\]) was greater than 0.5 (2-fold criterion).|GMR|2.06|||||TWO_SIDED|95.0|1.69|2.51||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||2.51|1.69|
71690794|NCT04530838|142897764|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.73|0.99||||||Serotype 1: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.99|0.73|
71690795|NCT04530838|142897764|OTHER||GMR|0.85|||||TWO_SIDED|95.0|0.74|0.98||||||Serotype 3: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||0.98|0.74|
71690796|NCT04530838|142897764|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.83|1.16||||||Serotype 4: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.83|
71690797|NCT04530838|142897764|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 5: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
71690798|NCT04530838|142897764|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.98|1.44||||||Serotype 6A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.44|0.98|
71690799|NCT04530838|142897764|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.72|1.21||||||Serotype 6B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.21|0.72|
71690800|NCT04530838|142897764|OTHER||GMR|0.96|||||TWO_SIDED|95.0|0.82|1.12||||||Serotype 7F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.12|0.82|
71690801|NCT04530838|142897764|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.85|1.16||||||Serotype 9V: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.16|0.85|
71690802|NCT04530838|142897764|OTHER||GMR|0.87|||||TWO_SIDED|95.0|0.72|1.04||||||Serotype 14: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.04|0.72|
71690803|NCT04530838|142897764|OTHER||GMR|0.92|||||TWO_SIDED|95.0|0.79|1.07||||||Serotype 18C: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.07|0.79|
71690804|NCT04530838|142897764|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||Serotype 19A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.84|
71690805|NCT04530838|142897764|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.87|1.1||||||Serotype 19F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.10|0.87|
71690806|NCT04530838|142897764|OTHER||GMR|0.98|||||TWO_SIDED|95.0|0.81|1.19||||||Serotype 23F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.19|0.81|
71690807|NCT04530838|142897764|OTHER||GMR|0.99|||||TWO_SIDED|95.0|0.87|1.13||||||Serotype 8: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.13|0.87|
71690808|NCT04530838|142897764|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.73|1.2||||||Serotype 10A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.20|0.73|
71690809|NCT04530838|142897764|OTHER||GMR|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||Serotype 11A: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.06|0.81|
71690810|NCT04530838|142897764|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.71|1.15||||||Serotype 12F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.71|
71690811|NCT04530838|142897764|OTHER||GMR|1.0|||||TWO_SIDED|95.0|0.85|1.18||||||Serotype 15B: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.18|0.85|
71690812|NCT04530838|142897764|OTHER||GMR|0.89|||||TWO_SIDED|95.0|0.78|1.02||||||Serotype 22F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.02|0.78|
71690813|NCT04530838|142897764|OTHER||GMR|0.95|||||TWO_SIDED|95.0|0.79|1.15||||||Serotype 33F: 2-Sided 95% CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.||1.15|0.79|
71932477|NCT03471182|143385427|SUPERIORITY|||||||0.87||||||Primary hypothesis of group differences (i.e., CUD vs HC-MRI participants) in fALFF was assessed as the significance level of the fixed-effect of group at a threshold of p\<0.05.|Mixed Models Analysis|||Outcome Measure Data were tested using a single linear mixed effects model. The 5 brain networks of interest (i.e., all 5 Rows of the Outcome Measure Data) were included in the model as a within-subjects factor for the fixed-effect of network. Group (i.e., CUD, HC-MRI) was included in the model as a between-subjects factor for the fixed-effect of group. The model also included the network-by-group interaction term and a factor to model the random-effect of participant.||||0.870
71932478|NCT04440163|143385428|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (\>) minus (-)10 percent (%), the non-inferiority was concluded.|Difference in percentage of participants|2.5|||||TWO_SIDED|95.0|-0.2|6.0|||Based on Miettinen and Nurminen method.|||MenA||6.0|-0.2|
71932479|NCT04440163|143385428|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|41.0|||||TWO_SIDED|95.0|34.4|47.5||||||MenC||47.5|34.4|
71932480|NCT04440163|143385428|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|24.3|||||TWO_SIDED|95.0|18.8|30.4||||||MenW||30.4|18.8|
71932481|NCT04440163|143385428|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|23.8|||||TWO_SIDED|95.0|18.0|30.1||||||MenY||30.1|18.0|
71932482|NCT04440163|143385429|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-3.2|||||TWO_SIDED|95.0|-6.5|0.5||||||MenA||0.5|-6.5|
71932483|NCT04440163|143385429|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.9|||||TWO_SIDED|95.0|-4.6|3.3||||||MenC||3.3|-4.6|
71932484|NCT04440163|143385429|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.7|||||TWO_SIDED|95.0|-2.2|4.3||||||MenW||4.3|-2.2|
71932485|NCT04440163|143385429|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-0.7|||||TWO_SIDED|95.0|-4.6|3.8||||||MenY||3.8|-4.6|
71932486|NCT04440163|143385430|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|9.6|||||TWO_SIDED|95.0|4.2|15.2||||||||15.2|4.2|
71932487|NCT04440163|143385431|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|4.0|||||TWO_SIDED|95.0|-0.7|8.9||||||A22||8.9|-0.7|
71932488|NCT04440163|143385431|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.4|||||TWO_SIDED|95.0|-1.0|4.3||||||A56||4.3|-1.0|
71932489|NCT04440163|143385431|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.9|||||TWO_SIDED|95.0|5.2|16.6||||||B24||16.6|5.2|
71932490|NCT04440163|143385431|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage|7.3|||||TWO_SIDED|95.0|2.9|11.9||||||B44||11.9|2.9|
71932491|NCT04440163|143385463|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.7|||||TWO_SIDED|95.0|-1.0|5.3||||||MenA||5.3|-1.0|
71690814|NCT00803712|142897771|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).||||<0.0001
71690815|NCT00803712|142897772|SUPERIORITY_OR_OTHER|||||||0.0002||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.0002
71690816|NCT00803712|142897773|SUPERIORITY_OR_OTHER|||||||0.0139||||||Adjusted p-value is presented. P-value is adjusted using Dubey and Armitage-Parmer method of adjusting for multiple comparisons|Cochran-Mantel-Haenszel|||||||0.0139
71690817|NCT00803712|142897774|SUPERIORITY_OR_OTHER|||||||0.2386||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel|||||||0.2386
71690818|NCT00803712|142897775|SUPERIORITY_OR_OTHER|||||||0.0875|||||||Cochran-Mantel-Haenszel|||||||0.0875
71690819|NCT00803712|142897776|SUPERIORITY_OR_OTHER|||||||0.4304|||||||Cochran-Mantel-Haenszel|||||||0.4304
71690820|NCT00803712|142897777|SUPERIORITY_OR_OTHER|||||||0.091|||||||Cochran-Mantel-Haenszel|||||||0.0910
71932492|NCT04440163|143385463|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|10.5|||||TWO_SIDED|95.0|3.0|17.9||||||MenC||17.9|3.0|
71932493|NCT04440163|143385463|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|6.3|||||TWO_SIDED|95.0|-0.1|13.1||||||MenW||13.1|-0.1|
71932494|NCT04440163|143385463|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|11.4|||||TWO_SIDED|95.0|5.0|18.2||||||MenY||18.2|5.0|
71932495|NCT04440163|143385464|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-2.2|||||TWO_SIDED|95.0|-5.2|1.4||||||MenA||1.4|-5.2|
71690821|NCT00803712|142897778|SUPERIORITY_OR_OTHER|||||||0.952|||||||Cochran-Mantel-Haenszel|||||||0.9520
71690822|NCT00803712|142897779|SUPERIORITY_OR_OTHER|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71932496|NCT04440163|143385464|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|-1.3|||||TWO_SIDED|95.0|-4.9|2.9||||||MenC||2.9|-4.9|
71932497|NCT04440163|143385464|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|1.0|||||TWO_SIDED|95.0|-1.6|4.6||||||MenW||4.6|-1.6|
71690823|NCT00803712|142897780|SUPERIORITY_OR_OTHER|||||||0.0611|||||||Cochran-Mantel-Haenszel|||||||0.0611
71690824|NCT00803712|142897781|SUPERIORITY_OR_OTHER|||||||0.3298|||||||Cochran-Mantel-Haenszel|||||||0.3298
71690825|NCT00803712|142897782|SUPERIORITY_OR_OTHER|||||||0.4436|||||||Cochran-Mantel-Haenszel|||||||0.4436
71690826|NCT00803712|142897783|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||<0.0001
71690827|NCT00803712|142897784|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
71690828|NCT00803712|142897785|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data||||||0.0040
71690829|NCT00803712|142897786|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.||||||<0.0001
71690830|NCT00803712|142897787|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium||||||<0.0001
71932498|NCT04440163|143385464|NON_INFERIORITY|95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was \> -10%, the non-inferiority was concluded.|Difference in percentage of participants|0.6|||||TWO_SIDED|95.0|-3.0|5.0||||||MenY||5.0|-3.0|
71932499|NCT02229487|143385465|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||||||0.209
71690831|NCT00803712|142897788|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
71690832|NCT00803712|142897789|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
71690833|NCT00803712|142897790|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.||||||<0.0001
71932500|NCT01954082|143385469|SUPERIORITY||Risk Ratio (RR)|1.41||||0.0095|TWO_SIDED|95.0|1.08|1.83||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality and/or severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the development of severe ROP and mortality.||1.83|1.08|0.0095
71932501|NCT01954082|143385470|SUPERIORITY||Risk Ratio (RR)|1.03||||0.6599|TWO_SIDED|95.0|0.91|1.16||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of BPD is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of BPD.||1.16|0.91|0.6599
71932502|NCT01954082|143385471|SUPERIORITY||Risk Ratio (RR)|1.05||||0.3883|TWO_SIDED|95.0|0.94|1.17||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of BPD or on mortality due to BDP.||1.17|0.94|0.3883
71932503|NCT01954082|143385472|SUPERIORITY||Risk Ratio (RR)|1.53||||0.0306|TWO_SIDED|95.0|1.03|2.25||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of mortality prior to ROP endpoint is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on survival to ROP endpoint.||2.25|1.03|0.0306
71932504|NCT01954082|143385473|SUPERIORITY||Risk Ratio (RR)|1.02||||0.7464|TWO_SIDED|95.0|0.91|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of ROP||1.14|0.91|0.7464
71932505|NCT01954082|143385474|SUPERIORITY||Risk Ratio (RR)|0.98||||0.7598|TWO_SIDED|95.0|0.83|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of Type 2 ROP or more severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of Type 2 ROP or more severe ROP.||1.14|0.83|0.7598
71932506|NCT01954082|143385475|SUPERIORITY||Risk Ratio (RR)|1.04||||0.8133|TWO_SIDED|95.0|0.74|1.48||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR\>1 implies that the risk of severe IVH is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence severe IVH.||1.48|0.74|0.8133
71932507|NCT01453374|143385516|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71932508|NCT01453374|143385517|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Fisher Exact|||||||>0.05
71932509|NCT01453374|143385518|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Fisher Exact|||||||<0.05
71932510|NCT01453374|143385524|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED||||||Fisher Exact|||||||<0.10
71932511|NCT05180630|143385526|OTHER|||||||0.012||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3). Comparisons were total mean scores for Open dome condition, Vented dome condition, and Custom earmolds with dynamic venting|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for streamed music, but there was no analysis between groups.||||0.012
71932512|NCT05180630|143385527|OTHER|||||||0.154||||||When p-value is adjusted for multiple comparisons, the level of statistical significance must be \</= to 0.01666667 (.05/3).|ANOVA|||Treatment order was not analyzed. A repeated measures ANOVA was performed to compare the effect of the coupling conditions on sound quality ratings for own voice, but there was no analysis between groups.||||0.154
71932513|NCT01029769|143385528|OTHER|"a logistic regression model with remission as the dependent variable and switch of treatment (yes/no) and PANSS-total score at visit 3 as independent variables was used. Multiple imputation (based upon 20 imputations, primary analysis), last observation carried forward and completers only analyses were performed."|||||=|0.01||||||Multiple imputation was performed separately for the switch and non-switch arms and the imputation model included the PANSS total score from all visits from phase II baseline (visit 2) onwards, remission at visit 7 and phase I arm allocation|Regression, Logistic|||Irrespective of the initially assigned antipsychotic treatment in period 1 of the trial (2-week-phase), the patients showing little improvement over the two weeks of treatment in period 1 now switched from the initial treatment in period 2 of the trial (6-week-phase) were grouped together as well as the patients non-switched from their initial treatment.||||=0.01
71932514|NCT00709735|143385531|SUPERIORITY||Mean Difference (Final Values)|-13.0|||||TWO_SIDED|95.0|-30.0|4.0|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||4.0|-30.0|
71932515|NCT00709735|143385532|SUPERIORITY||Mean Difference (Final Values)|-12.7|||||TWO_SIDED|95.0|-27.4|1.9|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)|||1.9|-27.4|
71932516|NCT00666718|143385533|NON_INFERIORITY_OR_EQUIVALENCE|"Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval (insulin lispro protamine suspension + insulin lispro minus insulin glargine+insulin lispro) at a significance level of 0.025 with 90% power."|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.11|0.31|||ANCOVA|||||0.31|-0.11|
71932517|NCT00666718|143385534|SUPERIORITY_OR_OTHER|||||||0.458||95.0||||p-value is for Week 12 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.4580
71932518|NCT00666718|143385534|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Week 24 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment\*country+treatment\*week+baseline HbA1c\*treatment (unstructured covariance used).||||||0.1070
71932519|NCT00666718|143385535|SUPERIORITY_OR_OTHER|||||||0.1333||95.0||||p-value is for HbA1c \<7.0%.|Fisher Exact|||||||0.1333
71932520|NCT00666718|143385535|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||p-value is for HbA1c \<=6.5%|Fisher Exact|||||||0.1213
71932521|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|0.37|||||TWO_SIDED|95.0|-0.43|1.17|||Mixed Models Analysis|Morning Pre-Meal measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.17|-0.43|
71932522|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|0.26|||||TWO_SIDED|95.0|-0.66|1.19|||Mixed Models Analysis|Morning Postprandial measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used)||||1.19|-0.66|
71932523|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.15|0.57|||Mixed Models Analysis|Midday Pre-Meal measurement = Treatment +country + week +treatment\*country + treatment\*week (unstructured covariance was used).||||0.57|-1.15|
71932524|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|||||TWO_SIDED|95.0|-0.46|1.4|||Mixed Models Analysis|Midday Postprandial measurement = Treatment+country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||1.40|-0.46|
71932525|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05|||||TWO_SIDED|95.0|-0.93|0.83|||Mixed Models Analysis|Evening Pre-Meal measurement = Treatment +country+week+treatment\*country + treatment\*week (unstructured covariance was used).||||0.83|-0.93|
71932526|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|0.46|||||TWO_SIDED|95.0|-0.41|1.34|||Mixed Models Analysis|Evening Postprandial measurement = Treatment+country+week +treatment\*country + treatment\*week (unstructured covariance was used).||||1.34|-0.41|
71932527|NCT00666718|143385536|SUPERIORITY_OR_OTHER||LS Mean Difference|0.14|||||TWO_SIDED|95.0|-0.67|0.96|||Mixed Models Analysis|0300 Hours measurement = Treatment+country+week+treatment\*country+treatment\*week (unstructured covariance was used).||||0.96|-0.67|
71932528|NCT00666718|143385537|SUPERIORITY_OR_OTHER|||||||0.5568||95.0||||p-value is for Fasting.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.5568
71932529|NCT00666718|143385537|SUPERIORITY_OR_OTHER|||||||0.7523||95.0||||p-value is for Post-breakfast.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.7523
71932530|NCT00666718|143385537|SUPERIORITY_OR_OTHER|||||||0.6448||95.0||||p-value is for Post-lunch.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment\*country (Mediterranean, rest of Europe)||||||0.6448
71932531|NCT00666718|143385537|SUPERIORITY_OR_OTHER|||||||0.9122||95.0||||p-value is for Post-dinner.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment\*country (Mediterranean, rest of Europe)||||||0.9122
71932532|NCT00666718|143385538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.53|||||TWO_SIDED|95.0|-1.19|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-1.19|
71932533|NCT00666718|143385538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|||||TWO_SIDED|95.0|-0.2|0.11|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.11|-0.20|
71932534|NCT00666718|143385538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|||||TWO_SIDED|95.0|-1.06|0.16|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.16|-1.06|
71932535|NCT00666718|143385538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|||||TWO_SIDED|95.0|-0.86|0.06|||Mixed Models Analysis|Hypoglycemia rate per 30 days = Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.06|-0.86|
71932536|NCT00666718|143385538|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.14|0.12|||Mixed Models Analysis|Hypoglycemia rate per 30 days=Treatment+Country+Week+Treatment\*Country+Treatment\*Week (unstructured covariance structure was used)||||0.12|-0.14|
71932537|NCT00666718|143385539|SUPERIORITY_OR_OTHER|||||||0.1701||95.0||||p-value is for \>=1 hypoglycemic episode.|Fisher Exact|||||||0.1701
71932538|NCT00666718|143385539|SUPERIORITY_OR_OTHER|||||||0.1727||95.0||||p-value is for \>=1 nocturnal hypoglycemic episode.|Fisher Exact|||||||0.1727
71932539|NCT00666718|143385539|SUPERIORITY_OR_OTHER|||||||0.2094||95.0||||p-value is for \>=1 non-nocturnal hypoglycemic episode.|Fisher Exact|||||||0.2094
71932540|NCT00666718|143385539|SUPERIORITY_OR_OTHER|||||||0.623||95.0||||p-value is for \>=1 severe hypoglycemic episode.|Fisher Exact|||||||0.6230
71932541|NCT00666718|143385541|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|||||TWO_SIDED|95.0|-0.86|0.55|||ANCOVA|weight change from baseline = Treatment + country + baseline Hb1Ac + baseline weight + treatment\*HbA1c baseline value||||0.55|-0.86|
71932542|NCT00666718|143385542|SUPERIORITY_OR_OTHER||LS Mean Difference|2.18|||||TWO_SIDED|95.0|-8.33|12.68|||Mixed Models Analysis|Total daily insulin dose=Treatment+country+week+treatment\*country+ treatment\*week (unstructured covariance was used).||||12.68|-8.33|
71932543|NCT03496207|143385544|SUPERIORITY||Difference in Least Squares Means|-151.1|STANDARD_ERROR_OF_MEAN|49.53||0.003|TWO_SIDED|95.0|-249.59|-52.63|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-52.63|-249.59|0.0030
71690834|NCT00803712|142897791|SUPERIORITY_OR_OTHER|||||||0.0085|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0085
71932544|NCT03496207|143385544|SUPERIORITY||Difference in Least Squares Means|-269.4|STANDARD_ERROR_OF_MEAN|48.48|<|0.0001|TWO_SIDED|95.0|-365.81|-173.03|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||-173.03|-365.81|<.0001
71932545|NCT03496207|143385545|SUPERIORITY||Difference in Least Squares Means|-13.9|STANDARD_ERROR_OF_MEAN|50.95||0.7851|TWO_SIDED|95.0|-113.85|86.06|||ANCOVA|ANCOVA was used to compare change from baseline values with randomization stratification factor (WHO functional class) and baseline PVR as covariate.||Analysis based on calculated LS means.||86.06|-113.85|0.7851
71932546|NCT03496207|143385546|SUPERIORITY||Multiple Imputation Mean Difference|-223.2|STANDARD_ERROR_OF_MEAN|57.45|<|0.0001|TWO_SIDED|95.0|-335.83|-110.49||Comparison of baseline and final value|ANCOVA||Standard multiple imputations are done with imputed values that are within the range of the minimum and maximum observed values using linear regression including baseline measurements.|||-110.49|-335.83|<.0001
71932547|NCT00810615|143385583|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|A repeated measures model was designed so as to incorporate the adjust for the repeated (dependent) measures within individuals over time.||ANCOVA, baseline measurement was considered as a covariate and group (sham or 2.4 ATA), treatment (15 treatments, 30 treatments, and 6 weeks) as well as the interaction between group and treatment were considered as the independent variables.||||0.05
71932548|NCT00810615|143385595|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5455||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with one significant event (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71932549|NCT00810615|143385596|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with two significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71932550|NCT00810615|143385597|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1111||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with three significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71932551|NCT00810615|143385598|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with four or more significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.||||
71932552|NCT02567266|143385605|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.2||0.338|TWO_SIDED|95.0|-0.58|0.2||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post-Treatment||.20|-.58|.338
71932553|NCT02567266|143385605|SUPERIORITY||Mean Difference (Net)|0.16|STANDARD_ERROR_OF_MEAN|0.2||0.425|TWO_SIDED|95.0|-0.24|0.57||Threshold: p \<.05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post Treatment||0.57|-0.24|0.425
71932554|NCT02567266|143385605|SUPERIORITY||Mean Difference (Net)|-0.36|STANDARD_ERROR_OF_MEAN|0.21||0.09|TWO_SIDED|95.0|-0.77|0.06||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Post||0.06|-0.77|0.09
71932555|NCT02567266|143385605|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.2||0.126|TWO_SIDED|95.0|-0.72|0.09||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.09|-0.72|0.126
71932556|NCT02567266|143385605|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.21||0.28|TWO_SIDED|95.0|-0.65|0.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.19|-0.65|0.28
71932557|NCT02567266|143385605|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.21||0.697|TWO_SIDED|95.0|-0.51|0.34||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-I at Follow-Up||0.34|-0.51|0.697
71932558|NCT02567266|143385606|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.26||0.779|TWO_SIDED|95.0|-0.6|0.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.45|-0.6|0.779
71932559|NCT02567266|143385606|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.27||0.66|TWO_SIDED|95.0|-0.42|0.67||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.67|-0.42|0.66
71932560|NCT02567266|143385606|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.629|TWO_SIDED|95.0|-0.51|0.31||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.31|-0.51|0.629
71932561|NCT02567266|143385606|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.2||0.938|TWO_SIDED|95.0|-0.41|0.38||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.38|-0.41|0.938
71932562|NCT02567266|143385606|SUPERIORITY||Mean Difference (Net)|0.09|STANDARD_ERROR_OF_MEAN|0.21||0.68|TWO_SIDED|95.0|-0.32|0.49||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Post||0.49|-0.32|0.68
71932563|NCT02567266|143385606|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.28||0.479|TWO_SIDED|95.0|-0.75|0.35||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGI-S at Follow-Up||0.35|-0.75|0.479
71932564|NCT02567266|143385607|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|1.58||0.852|TWO_SIDED|95.0|-2.85|3.45||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.45|-2.85|0.852
71932565|NCT02567266|143385607|SUPERIORITY||Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|1.62||0.917|TWO_SIDED|95.0|-3.41|3.07||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.07|-3.41|0.917
71932566|NCT02567266|143385607|SUPERIORITY||Mean Difference (Net)|0.47|STANDARD_ERROR_OF_MEAN|1.66||0.778|TWO_SIDED|95.0|-2.81|3.74||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Post||3.74|-2.81|0.778
71932567|NCT02567266|143385607|SUPERIORITY||Mean Difference (Net)|0.95|STANDARD_ERROR_OF_MEAN|2.12||0.66|TWO_SIDED|95.0|-3.3|5.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.19|-3.3|0.66
71932568|NCT02567266|143385607|SUPERIORITY||Mean Difference (Net)|-0.18|STANDARD_ERROR_OF_MEAN|2.19||0.935|TWO_SIDED|95.0|-4.55|4.19||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||4.19|-4.55|0.935
71932569|NCT02567266|143385607|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.21||0.615|TWO_SIDED|95.0|-3.29|5.55||Threshold: p \< .05|Mixed Models Analysis||A negative value for the mean difference indicates that the lower numbered Group has a lower mean than the higher numbered group.|DV = CGAS at Follow-Up||5.55|-3.29|0.615
71932570|NCT01255722|143385608|NON_INFERIORITY_OR_EQUIVALENCE|The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).|Mean Difference (Final Values)|-0.033||||0.05|TWO_SIDED|95.0|-0.088|0.021|||Chi-squared|||Iobitridol was compared to the best of the two comparators. The two-sided 95% confidence interval (CI) of the difference between both proportions (Iobitridol - Comparator) was computed and the lower limit of the CI compared to the clinical non-inferiority limit in the study. The non-inferiority of iobitridol over the best comparator was established if the lower limit of the two-sided 95% CI was equal to or higher than the clinical non-inferiority limit.||0.021|-0.088|0.05
71932571|NCT01255722|143385609|SUPERIORITY_OR_OTHER|||||||0.75|TWO_SIDED||||||Fisher Exact|||||||0.750
71932572|NCT01255722|143385611|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
71932573|NCT01255722|143385612|SUPERIORITY_OR_OTHER|||||||0.109|TWO_SIDED||||||Fisher Exact|||||||0.109
71932574|NCT01255722|143385613|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||Fisher Exact|||||||0.09
71932575|NCT02164539|143385614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71932576|NCT02164539|143385614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71932577|NCT02164539|143385614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71932578|NCT02164539|143385614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.103||||0.024|TWO_SIDED|95.0|0.014|0.193|||Final step dose response model|||||0.193|0.014|0.024
71932579|NCT02164539|143385614|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.073||||0.152|TWO_SIDED|95.0|-0.027|0.172|||Final dose response model|||||0.172|-0.027|0.152
71932580|NCT02164539|143385615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.01|TWO_SIDED|95.0|-1.7|-0.2|||ANCOVA|||||-0.2|-1.7|0.010
71932581|NCT02164539|143385615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.004|TWO_SIDED|95.0|-1.9|-0.4|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.4|-1.9|0.004
71932582|NCT02164539|143385615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.083|TWO_SIDED|95.0|-1.4|0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||0.1|-1.4|0.083
71690835|NCT00803712|142897792|SUPERIORITY_OR_OTHER|||||||0.071|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.0710
71690836|NCT00803712|142897793|SUPERIORITY_OR_OTHER|||||||0.3546|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.3546
71932583|NCT02164539|143385615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.014|TWO_SIDED|95.0|-1.5|-0.2|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.2|-1.5|0.014
71932584|NCT02164539|143385615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.031|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.|||-0.1|-1.4|0.031
71932585|NCT02164539|143385616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1|||<|0.001|TWO_SIDED|95.0|-4.6|-1.7|||ANCOVA|||||-1.7|-4.6|<0.001
71932586|NCT02164539|143385616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0|||<|0.001|TWO_SIDED|95.0|-4.5|-1.6|||ANCOVA|||||-1.6|-4.5|<0.001
71932587|NCT02164539|143385616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.007|TWO_SIDED|95.0|-3.4|-0.6|||ANCOVA|||||-0.6|-3.4|0.007
71932588|NCT02164539|143385616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.002|TWO_SIDED|95.0|-3.2|-0.7|||ANCOVA|||||-0.7|-3.2|0.002
71932589|NCT02164539|143385616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.009|TWO_SIDED|95.0|-2.9|-0.4|||ANCOVA|||||-0.4|-2.9|0.009
71932590|NCT02164539|143385617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.1||||0.004||95.0|5.9|30.3|||ANCOVA|||||30.3|5.9|0.004
71932591|NCT02164539|143385617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|21.8|||<|0.001|TWO_SIDED|95.0|9.4|34.1|||ANCOVA|||||34.1|9.4|<0.001
71932592|NCT02164539|143385617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|19.7||||0.001|TWO_SIDED|95.0|7.7|31.7|||ANCOVA|||||31.7|7.7|0.001
71932593|NCT02164539|143385617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|24.8|||<|0.001|TWO_SIDED|95.0|14.1|35.4|||ANCOVA|||||35.4|14.1|<0.001
71932594|NCT02164539|143385617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.5|||<|0.001|TWO_SIDED|95.0|8.0|29.1|||ANCOVA|||||29.1|8.0|<0.001
71932595|NCT02164539|143385618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.045||||0.264|TWO_SIDED|95.0|-0.034|0.125|||ANCOVA|||||0.125|-0.034|0.264
71932596|NCT02164539|143385618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.328|TWO_SIDED|95.0|-0.041|0.121|||ANCOVA|||||0.121|-0.041|0.328
71932597|NCT02164539|143385618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.025||||0.534|TWO_SIDED|95.0|-0.054|0.103|||ANCOVA|||||0.103|-0.054|0.534
71932598|NCT02164539|143385618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.005||||0.895|TWO_SIDED|95.0|-0.065|0.075|||ANCOVA|||||0.075|-0.065|0.895
71932599|NCT02164539|143385618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.076||||0.031|TWO_SIDED|95.0|0.007|0.146|||ANCOVA|||||0.146|0.007|0.031
71932600|NCT02164539|143385619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.088||||0.019|TWO_SIDED|95.0|-0.162|-0.014|||ANCOVA|||||-0.014|-0.162|0.019
71932601|NCT02164539|143385619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.091||||0.017|TWO_SIDED|95.0|-0.165|-0.016|||ANCOVA|||||-0.016|-0.165|0.017
71932602|NCT02164539|143385619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.089||||0.017|TWO_SIDED|95.0|-0.162|-0.016|||ANCOVA|||||-0.016|-0.162|0.017
71932603|NCT02164539|143385619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.066|TWO_SIDED|95.0|-0.124|0.004|||ANCOVA|||||0.004|-0.124|0.066
71932604|NCT02164539|143385619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.163|||<|0.001|TWO_SIDED|95.0|-0.227|-0.099|||ANCOVA|||||-0.099|-0.227|<0.001
71932605|NCT02643966|143385620|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Year/Screen 1.|simple proportions|1.3||||0.005|TWO_SIDED|95.0|0.3|2.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||2.1|0.3|0.005
71932606|NCT02643966|143385620|OTHER|We compared DBT cancer yield per 1,000 for first observer (usual care) vs DBT and WBUS cancer yield per 1,000 for first observer for Years/Screens 2 \& 3.|simple proportions|1.0|||<|0.001|TWO_SIDED|95.0|0.4|1.5||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||1.5|0.4|<0.001
71932607|NCT02643966|143385621|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Year/Screen 1.|simple proportions|17.8||||0.005|TWO_SIDED|95.0|4.4|31.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||31.1|4.4|0.005
71932608|NCT02643966|143385621|OTHER|We compared DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer for Years/Screens 2 and 3.|simple proportions|13.5|||<|0.001|TWO_SIDED|95.0|4.9|22.3||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.||22.3|4.9|< 0.001
71690837|NCT00803712|142897794|SUPERIORITY_OR_OTHER|||||||0.7518|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.||||||0.7518
71690838|NCT02672176|142897802|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71932609|NCT02643966|143385623|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Year/Screen 1.|Slope|4.5|||<|0.001|TWO_SIDED|95.0|3.8|5.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||5.1|3.8|< 0.001
71932610|NCT02643966|143385623|OTHER|We compared DBT false positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer for Years/Screens 2 \& 3.|simple proportions|3.7|||<|0.001|TWO_SIDED|95.0|3.3|4.1||The threshold for statistical significance was p = 0.05|nonparametric bootstrap approach|The 95% CIs for differences were estimated using nonparametric bootstrap approach on the basis of 10,000 replicates with women as resampling units||||4.1|3.3|< 0.001
71932611|NCT03611751|143385694|SUPERIORITY||Odds Ratio (OR)|10.55|||<|0.0001|TWO_SIDED|95.0|6.54|17.0|||Cochran-Mantel-Haenszel|||||17.00|6.54|<0.0001
71932612|NCT03611751|143385695|SUPERIORITY||Odds Ratio (OR)|10.49|||<|0.0001|TWO_SIDED|95.0|6.65|16.55|||Cochran-Mantel-Haenszel|||||16.55|6.65|<0.0001
71932613|NCT03611751|143385696|SUPERIORITY||Odds Ratio (OR)|11.42|||<|0.0001|TWO_SIDED|95.0|5.45|23.93|||Cochran-Mantel-Haenszel|||||23.93|5.45|<0.0001
71932614|NCT03611751|143385696|SUPERIORITY||Odds Ratio (OR)|1.74||||0.0046|TWO_SIDED|95.0|1.18|2.56|||Cochran-Mantel-Haenszel|||||2.56|1.18|0.0046
71932615|NCT03611751|143385697|SUPERIORITY||Odds Ratio (OR)|9.21|||<|0.001|TWO_SIDED|95.0|2.89|29.4|||Cochran-Mantel-Haenszel|||||29.40|2.89|<0.001
71932616|NCT03611751|143385697|SUPERIORITY||Odds Ratio (OR)|2.55||||0.0051|TWO_SIDED|95.0|1.3|5.0|||Cochran-Mantel-Haenszel|||||5.00|1.30|0.0051
71932617|NCT03611751|143385698|SUPERIORITY||Odds Ratio (OR)|14.44|||<|0.0001|TWO_SIDED|95.0|4.62|45.11|||Cochran-Mantel-Haenszel|||||45.11|4.62|<0.0001
71932618|NCT03611751|143385698|SUPERIORITY||Odds Ratio (OR)|2.85||||0.0002|TWO_SIDED|95.0|1.61|5.03|||Cochran-Mantel-Haenszel|||||5.03|1.61|0.0002
71932619|NCT03611751|143385699|SUPERIORITY||Mean Difference (Net)|-23.6|STANDARD_ERROR_OF_MEAN|1.67|<|0.0001|TWO_SIDED|95.0|-26.9|-20.3|||ANCOVA|||||-20.3|-26.9|<0.0001
71932620|NCT03611751|143385699|SUPERIORITY||Mean Difference (Net)|-7.2|STANDARD_ERROR_OF_MEAN|1.68|<|0.0001|TWO_SIDED|95.0|-10.5|-3.9|||ANCOVA|||||-3.9|-10.5|<0.0001
71932621|NCT03611751|143385700|SUPERIORITY||Odds Ratio (OR)|6.4||||0.0005|TWO_SIDED|95.0|1.94|21.15|||Cochran-Mantel-Haenszel|||||21.15|1.94|0.0005
71932622|NCT03611751|143385700|SUPERIORITY||Odds Ratio (OR)|1.82||||0.0928|TWO_SIDED|95.0|0.89|3.71|||Cochran-Mantel-Haenszel|||||3.71|0.89|0.0928
71932623|NCT03611751|143385701|SUPERIORITY||Odds Ratio (OR)|6.85|||<|0.0001|TWO_SIDED|95.0|4.34|10.81|||Cochran-Mantel-Haenszel|||||10.81|4.34|<0.0001
71932624|NCT03611751|143385701|SUPERIORITY||Odds Ratio (OR)|2.63|||<|0.0001|TWO_SIDED|95.0|1.77|3.91|||Cochran-Mantel-Haenszel|||||3.91|1.77|<0.0001
71932625|NCT03611751|143385702|SUPERIORITY||Odds Ratio (OR)|5.38|||<|0.0001|TWO_SIDED|95.0|3.42|8.47|||Cochran-Mantel-Haenszel|||||8.47|3.42|<0.0001
71932626|NCT03611751|143385703|SUPERIORITY||Odds Ratio (OR)|3.21||||0.0621|TWO_SIDED|95.0|0.88|11.79|||Cochran-Mantel-Haenszel|||||11.79|0.88|0.0621
71932627|NCT03611751|143385704|SUPERIORITY||Odds Ratio (OR)|0.64||||0.6692|TWO_SIDED|95.0|0.06|7.46|||Cochran-Mantel-Haenszel|||||7.46|0.06|0.6692
71932628|NCT03611751|143385704|SUPERIORITY||Odds Ratio (OR)|0.32||||0.3793|TWO_SIDED|95.0|0.02|5.56|||Cochran-Mantel-Haenszel|||||5.56|0.02|0.3793
71932629|NCT03611751|143385705|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0004|TWO_SIDED|95.0|1.29|2.41|||Cochran-Mantel-Haenszel|||||2.41|1.29|0.0004
71932630|NCT03611751|143385706|SUPERIORITY||Odds Ratio (OR)|2.01|||<|0.0001|TWO_SIDED|95.0|1.45|2.78|||Cochran-Mantel-Haenszel|||||2.78|1.45|<0.0001
71690839|NCT02672176|142897803|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71932631|NCT03611751|143385707|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71932632|NCT03611751|143385708|SUPERIORITY||Odds Ratio (OR)|2.47|||<|0.0001|TWO_SIDED|95.0|1.78|3.43|||Cochran-Mantel-Haenszel|||||3.43|1.78|<0.0001
71932633|NCT03611751|143385709|SUPERIORITY||Odds Ratio (OR)|2.44|||<|0.0001|TWO_SIDED|95.0|1.78|3.36|||Cochran-Mantel-Haenszel|||||3.36|1.78|<0.0001
71932634|NCT03611751|143385710|SUPERIORITY||Odds Ratio (OR)|2.07||||0.0001|TWO_SIDED|95.0|1.43|3.01|||Cochran-Mantel-Haenszel|||||3.01|1.43|0.0001
71932635|NCT03672396|143385713|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.13||||0.378|TWO_SIDED|95.0|-0.2|0.4|||t-test, 2 sided|||||0.4|-0.2|0.378
71932636|NCT03672396|143385714|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.35||||0.586|TWO_SIDED|95.0|-1.0|1.7|||t-test, 2 sided|||||1.7|-1.0|0.586
71932637|NCT03672396|143385715|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.25||||0.252|TWO_SIDED|95.0|-0.7|0.2|||t-test, 2 sided|||||0.2|-0.7|0.252
71932638|NCT03672396|143385716|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-16.3||||0.111|TWO_SIDED|95.0|-36.9|4.3|||t-test, 2 sided|Mean difference calculated as Post - Pre.||||4.3|-36.9|0.111
71932639|NCT03672396|143385717|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.4||||0.579|TWO_SIDED|95.0|-4.3|7.2|||t-test, 2 sided|||||7.2|-4.3|0.579
71932640|NCT03672396|143385718|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.1||||0.948|TWO_SIDED|95.0|-3.9|3.7|||t-test, 2 sided|||||3.7|-3.9|0.948
71932641|NCT03672396|143385719|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.2||||0.594|TWO_SIDED|95.0|-1.1|0.7|||t-test, 2 sided|||||0.7|-1.1|0.594
71932642|NCT03672396|143385720|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.8||||0.274|TWO_SIDED|95.0|-2.3|0.7|||t-test, 2 sided|||||0.7|-2.3|0.274
71932643|NCT03672396|143385721|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.89||||0.013|TWO_SIDED|95.0|0.48|3.29|||t-test, 2 sided|||||3.29|0.48|0.013
71932644|NCT03672396|143385722|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|4.16||||0.369|TWO_SIDED|95.0|-5.54|13.85|||t-test, 2 sided|||||13.85|-5.54|0.369
71932645|NCT03672396|143385723|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.4||||0.945|TWO_SIDED|95.0|-13.5|12.7|||t-test, 2 sided|||||12.7|-13.5|0.945
71932646|NCT03672396|143385724|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.42|TWO_SIDED|95.0|-2.0|4.6|||t-test, 2 sided|||||4.6|-2.0|0.420
71932647|NCT03672396|143385725|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|-0.6||||0.941|TWO_SIDED|95.0|-16.9|15.8|||t-test, 2 sided|||||15.8|-16.9|0.941
71932648|NCT03672396|143385726|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|2.3||||0.203|TWO_SIDED|95.0|-1.4|5.9|||t-test, 2 sided|||||5.9|-1.4|0.203
71932649|NCT03672396|143385727|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|1.3||||0.057|TWO_SIDED|95.0|-0.04|2.6|||t-test, 2 sided|||||2.6|-0.04|0.057
71932650|NCT03672396|143385728|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.1||||0.809|TWO_SIDED|95.0|-1.0|1.3|||t-test, 2 sided|||||1.3|-1.0|0.809
71932651|NCT03672396|143385729|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.4||||0.191|TWO_SIDED|95.0|-0.3|1.1|||t-test, 2 sided|||||1.1|-0.3|0.191
71932652|NCT03672396|143385730|OTHER|Paired t-test analysis between baseline and post-testing values from a single group of individuals who completed both testing sessions.|Mean Difference (Final Values)|0.5||||0.237|TWO_SIDED|95.0|-0.3|1.3|||t-test, 2 sided|||||1.3|-0.3|0.237
71932653|NCT02441179|143385741|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||Kruskal-Wallis|||||||0.006
71932654|NCT02441179|143385742|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED||||||Kruskal-Wallis|||||||0.012
71932655|NCT02441179|143385743|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Kruskal-Wallis|||||||0.16
71932656|NCT02441179|143385744|SUPERIORITY_OR_OTHER|||||||0.57|TWO_SIDED||||||Chi-squared|||||||0.57
71932657|NCT02441179|143385745|SUPERIORITY_OR_OTHER|||||||0.14|TWO_SIDED||||||Chi-squared|||||||0.14
71932658|NCT02441179|143385746|SUPERIORITY_OR_OTHER|||||||0.43|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.43
71932659|NCT02441179|143385747|SUPERIORITY_OR_OTHER|||||||0.55|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.55
71932660|NCT02139306|143385836|SUPERIORITY||Mean Difference (Net)|0.597|STANDARD_ERROR_OF_MEAN|0.957||0.5336|TWO_SIDED|95.0|-1.2881|2.4813|||Mixed-model, repeated-measures|||||2.4813|-1.2881|0.5336
71932661|NCT02139306|143385837|SUPERIORITY||Rate ratio|0.8567|STANDARD_ERROR_OF_MEAN|0.1577||0.4008|TWO_SIDED|95.0|0.5973|1.2288|||Negative binomial regression|||||1.2288|0.5973|0.4008
71932662|NCT02139306|143385838|SUPERIORITY||Mean Difference (Net)|0.272|STANDARD_ERROR_OF_MEAN|1.93||0.8881|TWO_SIDED|95.0|-3.5292|4.0731|||Mixed-model, repeated measures|||||4.0731|-3.5292|0.8881
71932663|NCT02139306|143385839|SUPERIORITY||Mean Difference (Net)|-0.065|STANDARD_ERROR_OF_MEAN|0.1312||0.6208|TWO_SIDED|95.0|-0.3233|0.1934|||Mixed-model, repeated measures|||||0.1934|-0.3233|0.6208
71932664|NCT03033069|143385859|SUPERIORITY||Least Squares (LS ) Mean Difference|-5.99|||=|0.0021|TWO_SIDED|95.0|-9.79|-2.19|||Mixed Model Repeated Measures (MMRM)|||MMRM analysis with an unstructured (UN) variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-2.19|-9.79|=0.0021
71932665|NCT03033069|143385859|SUPERIORITY||LS Mean Difference|-1.74|||=|0.3868|TWO_SIDED|95.0|-5.7|2.22|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.22|-5.70|=0.3868
71932666|NCT03033069|143385859|SUPERIORITY||LS Mean Difference|-0.91|||=|0.6399|TWO_SIDED|95.0|-4.74|2.92|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||2.92|-4.74|=0.6399
71932667|NCT03033069|143385859|SUPERIORITY||LS Mean Difference|-5.08|||=|0.0106|TWO_SIDED|95.0|-8.96|-1.2|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-1.20|-8.96|=0.0106
71932668|NCT03033069|143385859|SUPERIORITY||LS Mean Difference|-4.24|||=|0.0384|TWO_SIDED|95.0|-8.26|-0.23|||MMRM|||MMRM analysis with an UN variance covariance structure was performed. The model included fixed class-effect terms for treatment, trial site, type of trauma (combat related Yes/No), visit week, and an interaction term of treatment by visit week and included the interaction term of baseline values of CAPS-5 total score by visit week as a covariate.||-0.23|-8.26|=0.0384
71932669|NCT00430638|143385860|SUPERIORITY_OR_OTHER||||||<|0.0001||||||No multiplicity adjustments|ANCOVA|The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932670|NCT00430638|143385861|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932671|NCT00430638|143385862|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932672|NCT00430638|143385862|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932673|NCT00430638|143385863|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932674|NCT00430638|143385863|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932675|NCT00430638|143385864|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932676|NCT00430638|143385864|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population \< 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||<0.0001
71932677|NCT00430638|143385865|SUPERIORITY_OR_OTHER|||||||0.0125||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - \> or equal to 65 years old): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0125
71932678|NCT00430638|143385865|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) \> or equal to 65): For the efficacy population \> or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.||||0.0006
71932679|NCT00430638|143385866|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932680|NCT00430638|143385866|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932681|NCT00430638|143385867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932682|NCT00430638|143385867|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932683|NCT00430638|143385868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932684|NCT00430638|143385868|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932685|NCT00430638|143385869|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932686|NCT00430638|143385869|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons||||<0.0001
71932687|NCT01142466|143385891|SUPERIORITY_OR_OTHER|||||||0.1384|||||||Log Rank|||Two-sided log rank test with alpha equal to 0.05 was used as the appropriate nonparametric method to compare the two groups.||||0.1384
71932688|NCT01142466|143385892|SUPERIORITY_OR_OTHER|||||||0.2635||95.0|||||Fisher Exact|||||||0.2635
71932689|NCT03712137|143385940|SUPERIORITY||Responder Rate Difference|30.9||||0.0001|TWO_SIDED|95.0|15.33|46.54|||Multiple Imputation|The procedure used to perform Multiple Imputation is PROC MIANALYZE in SAS with normal approximation||||46.54|15.33|0.0001
71932690|NCT03712137|143385943|SUPERIORITY||Mean Difference (Final Values)|45.9|||<|0.0001|TWO_SIDED|95.0|40.45|51.28|||Paired T-test|||||51.28|40.45|<0.0001
71932691|NCT03398928|143386104|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71690840|NCT02672176|142897804|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71690841|NCT02672176|142897805|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71932692|NCT03398928|143386105|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71932693|NCT03398928|143386108|SUPERIORITY|||||||0.002||||||The statistical analysis applies to all the rows|Chi-squared|||||||0.002
71932694|NCT03398928|143386109|SUPERIORITY|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
71932695|NCT00370396|143386114|NON_INFERIORITY_OR_EQUIVALENCE|Standardized asymptotic 95% confidence interval (CI) for the difference \[Synflorix-Synflorix minus Prevenar-Prevenar\] in terms of percentages of subjects reporting rectal fever \>39.0°C was computed.|Difference in percentage|-4.43|||||TWO_SIDED|95.0|-11.85|-0.21||||||Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever \> 39.0°C.||-0.21|-11.85|
71932696|NCT03162354|143386238|OTHER||Odds Ratio (OR)|0.64||||0.11|TWO_SIDED|95.0|0.37|1.11||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|We powered this hypothesis to detect a 17% increase (from 73% to 90%) in higher risk patients evaluated thoroughly for abuse at intervention sites, compared to baseline in prior PediBIRN studies. Generalized linear mixed-effects models were adopted to analyze 1,000 Monte Carlo datasets from simulation. For the target sample size of 304 higher risk patients (152 in each arm), the proportion of simulated datasets that yielded a statistically significant result for the primary hypothesis was 95.7%.||1.11|0.37|0.11
71932697|NCT03162354|143386239|OTHER||Odds Ratio (OR)|0.69||||0.49|TWO_SIDED|95.0|0.24|1.98||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.98|0.24|0.49
71932698|NCT03162354|143386240|OTHER||Odds Ratio (OR)|1.88||||0.22|TWO_SIDED|95.0|0.69|5.13||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||5.13|0.69|0.22
71932699|NCT03162354|143386241|OTHER||Odds Ratio (OR)|0.48||||0.01|TWO_SIDED|95.0|0.27|0.85||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.85|0.27|0.01
71932700|NCT03162354|143386242|OTHER||Odds Ratio (OR)|1.09||||0.84|TWO_SIDED|95.0|0.46|2.6||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.60|0.46|0.84
71932701|NCT03162354|143386243|OTHER||Odds Ratio (OR)|1.84||||0.05|TWO_SIDED|95.0|1.0|3.38||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.38|1.00|0.05
71932702|NCT03162354|143386244|OTHER||Odds Ratio (OR)|1.22||||0.71|TWO_SIDED|95.0|0.43|3.49||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||3.49|0.43|0.71
71932703|NCT03162354|143386245|OTHER||Odds Ratio (OR)|1.04||||0.86|TWO_SIDED|95.0|0.7|1.53||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||1.53|0.70|0.86
71932704|NCT03162354|143386246|OTHER||Odds Ratio (OR)|2.02||||0.01|TWO_SIDED|95.0|1.16|3.52||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline prior studies to the cluster randomized trial|||3.52|1.16|0.01
71932705|NCT03162354|143386247|OTHER||Odds Ratio (OR)|0.42|||<|0.001|TWO_SIDED|95.0|0.26|0.67||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior studies to the cluster randomized trial.|||0.67|0.26|<.001
71932706|NCT03162354|143386248|OTHER||Odds Ratio (OR)|0.46||||0.14|TWO_SIDED|95.0|0.16|1.31||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from baseline in prior PediBIRN studies to the clinical trial.|||1.31|0.16|0.14
71932707|NCT03162354|143386250|OTHER||Odds Ratio (OR)|0.74||||0.57|TWO_SIDED|95.0|0.27|2.05||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||2.05|0.27|0.57
71932708|NCT03162354|143386251|OTHER||Odds Ratio (OR)|0.63||||0.04|TWO_SIDED|95.0|0.4|0.99||The threshold for statistical significance was p = 0.05.|Chi-squared||The direction of the comparison is from intervention sites to control sites.|||0.99|0.40|0.04
71932709|NCT00446134|143386253|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Other|12.75|STANDARD_DEVIATION|5.0||0.167|TWO_SIDED|95.0|-3.65|29.15|||Fisher Exact|||||29.15|-3.65|0.167
71932710|NCT00446134|143386253|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|5.71|STANDARD_DEVIATION|5.0||0.611|TWO_SIDED|95.0|-10.76|22.19|||Fisher Exact|||||22.19|-10.76|0.611
71932711|NCT00446134|143386253|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.98|STANDARD_DEVIATION|5.0||0.736|TWO_SIDED|95.0|-13.67|19.63|||Fisher Exact|||||19.63|-13.67|0.736
71932712|NCT00446134|143386253|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|7.04|STANDARD_DEVIATION|5.0||0.485|TWO_SIDED|95.0|-9.28|23.35|||Fisher Exact|||||23.35|-9.28|0.485
71932713|NCT00446134|143386253|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|9.77|STANDARD_DEVIATION|5.0||0.295|TWO_SIDED|95.0|-6.72|26.26|||Fisher Exact|||||26.26|-6.72|0.295
71932714|NCT00446134|143386253|NON_INFERIORITY_OR_EQUIVALENCE|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.73|STANDARD_DEVIATION|5.0||0.864|TWO_SIDED|95.0|-13.84|19.3|||Fisher Exact|||||19.3|-13.84|0.864
71932715|NCT00446134|143386254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.4|STANDARD_DEVIATION|5.0||0.0304|TWO_SIDED|95.0|2.31|30.57|||Chi-squared|||||30.57|2.31|0.0304
71932716|NCT00446134|143386254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.1|STANDARD_DEVIATION|5.0||0.0293|TWO_SIDED|95.0|3.22|31.06|||Chi-squared|||||31.06|3.22|0.0293
71932717|NCT00446134|143386254|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9|STANDARD_DEVIATION|5.0||0.5816|TWO_SIDED|95.0|-10.41|20.24|||Chi-squared|||||20.24|-10.41|0.5816
71932718|NCT00446134|143386255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
71932719|NCT00446134|143386255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.73|14.73|||Fisher Exact|||||14.73|-14.73|0.9999
71932720|NCT00446134|143386255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.11|15.71|||Fisher Exact|||||15.71|-14.11|0.9999
71932721|NCT00446134|143386255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-13.78|16.22|||Fisher Exact|||||16.22|-13.78|0.9999
71932722|NCT00446134|143386255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.42|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-14.76|15.59|||Fisher Exact|||||15.59|-14.76|0.9999
71932723|NCT00446134|143386255|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8|STANDARD_DEVIATION|5.0||0.9999|TWO_SIDED|95.0|-15.71|14.11|||Fisher Exact|||||14.11|-15.71|0.9999
71932724|NCT03909971|143386260|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71690842|NCT02672176|142897806|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71932725|NCT04542330|143386294|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||Acute infection was analysed as recurrent events using an Andersen-Gill Cox proportional hazards regression model with time since inclusion as underlying time scale. The analysis was done for the composite outcome and for all subcomponents separately, presenting Hazard Ratios (HR) with 95% Confidence Intervals (CI) for each. For all recurrent outcomes, a wash-out period of 14 days was used to define new events.||||< 0.05
71690843|NCT02672176|142897807|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71932726|NCT04542330|143386295|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for primary outcome.||||< 0.05
71932727|NCT04542330|143386296|SUPERIORITY||||||<|0.05|||||||Andersen-Gill Cox|||The secondary outcome, self-reported respiratory symptoms, was analysed the same way as the primary outcome (recurrent events).||||< 0.05
71932728|NCT04542330|143386297|SUPERIORITY||||||<|0.05|||||||Regression, Cox|||Verified SARS-CoV-2 infection (first event) and all-cause hospitalisation (first event) was analysed using standard Cox proportional hazards models, but otherwise as described for the primary outcome.||||< 0.05
71932729|NCT02176642|143386301|NON_INFERIORITY|We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||||||0.2
71932730|NCT02176642|143386302|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.4
71932731|NCT02176642|143386303|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||||||0.48
71932732|NCT02176642|143386304|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||||||0.26
71932733|NCT02176642|143386305|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71932734|NCT02176642|143386306|SUPERIORITY|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71932735|NCT02176642|143386307|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||||||0.44
71932736|NCT02176642|143386308|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||||||0.73
71932737|NCT02176642|143386309|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||||||0.94
71690844|NCT02672176|142897808|EQUIVALENCE|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71690845|NCT02672176|142897809|EQUIVALENCE|Information in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71690846|NCT02672176|142897810|EQUIVALENCE|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71690847|NCT03272347|142897853|OTHER|The 95% confidence intervals (CIs) were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.9|||||TWO_SIDED|95.0|-12.5|18.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||18.3|-12.5|
71932738|NCT00295620|143386310|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.425|TWO_SIDED|95.0|0.79|1.11|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event||1.11|0.79|0.425
71932739|NCT00295620|143386311|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.867|TWO_SIDED|95.0|0.83|1.25|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event||1.25|0.83|0.867
71932740|NCT00295620|143386312|SUPERIORITY||Hazard Ratio (HR)|1.35||||0.052|TWO_SIDED|95.0|1.0|1.84|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture||1.84|1.00|0.052
71932741|NCT00295620|143386313|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.678|TWO_SIDED|95.0|0.81|1.38|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma||1.38|0.81|0.678
71932742|NCT00295620|143386314|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.531|TWO_SIDED|95.0|0.75|1.77|||Log Rank|||Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma||1.77|0.75|0.531
71932743|NCT02989610|143386320|SUPERIORITY|Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
71932744|NCT02989610|143386321|NON_INFERIORITY|Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.|||||<|0.0001|||||||Clopper-Pearson method|||Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.||||<0.0001
71932745|NCT02989610|143386322|SUPERIORITY|||||||1|||||||t-test, 1 sided|Paired t-test.||"Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.~The p-value presented is calculated and does not represent the threshold. The statistical test used for this endpoint is single sided, and the observed difference was in the opposite direction of the tested difference, leading to a p-value that is equivalent to 1 within the significance of the statistical software used."||||1.0000
71932746|NCT04179474|143386323|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.55|||||TWO_SIDED|90.0|96.21|115.79|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.79|96.21|
71932747|NCT04179474|143386324|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.03|||||TWO_SIDED|90.0|89.55|123.19|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||123.19|89.55|
71932748|NCT04179474|143386325|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|105.38|||||TWO_SIDED|90.0|96.19|115.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||115.45|96.19|
71932749|NCT04179474|143386326|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|104.76|||||TWO_SIDED|90.0|89.68|122.38|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||122.38|89.68|
71932750|NCT04179474|143386327|EQUIVALENCE|"No effect of co-administration with erenumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with erenumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|103.86|||||TWO_SIDED|90.0|93.01|115.98|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Erenumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means||115.98|93.01|
71932751|NCT04179474|143386328|EQUIVALENCE|"No effect of co-administration with galcanezumab on the PK of ubrogepant was concluded if the 90% CIs for the geometric mean ratios of ubrogepant PK parameters for test study intervention (ubrogepant in combination with galcanezumab) versus reference study intervention (ubrogepant alone) were within the limits of 80% to 125%."|Ratio of Geometric Mean Percentage|99.55|||||TWO_SIDED|90.0|82.27|120.45|||||Ratio of Geometric Mean Percentage=Ubrogepant in Combination with Galcanezumab/Ubrogepant Alone \* 100|A linear mixed-effects model with study intervention as fixed effect and participant as a random effect was used to determine the Geometric Means.||120.45|82.27|
71932752|NCT02556632|143386345|OTHER|||||||0.9306|||||||ANOVA|||||||0.9306
71932753|NCT02556632|143386346|OTHER|||||||0.8048|||||||Fisher Exact|||||||0.8048
71932754|NCT02556632|143386347|OTHER|||||||0.8591|||||||ANOVA|||||||0.8591
71932755|NCT04508621|143386369|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.115|TWO_SIDED|95.0|-0.6|0.1|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||0.1|-0.6|0.115
71932756|NCT04508621|143386370|SUPERIORITY|Patients with missing data considered non-responders.|Difference in Proportions|8.0||||0.038|TWO_SIDED|95.0|0.5|15.5|||Pearson Chi-Squared|||||15.5|0.5|0.038
71932757|NCT04508621|143386371|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.55||0.03|TWO_SIDED|95.0|-6.4|-0.3|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment difference = TNX-102 SL - Placebo|||-0.3|-6.4|0.030
71932758|NCT04508621|143386372|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|1.46||0.797|TWO_SIDED|95.0|-3.2|2.5|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||2.5|-3.2|0.797
71932759|NCT04508621|143386373|SUPERIORITY||LS Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.8||0.004|TWO_SIDED|95.0|-3.8|-0.7|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||-0.7|-3.8|0.004
71932760|NCT04508621|143386374|SUPERIORITY||LS Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.74||0.101|TWO_SIDED|95.0|-2.7|0.2|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.2|-2.7|0.101
71932761|NCT04508621|143386375|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.094|TWO_SIDED|95.0|-0.6|0.0|||Mixed Model Repeated Measures|Multiple imputation used for missing data.|Treatment Difference = TNX-102 SL - Placebo|||0.0|-0.6|0.094
71932762|NCT01083901|143386385|SUPERIORITY_OR_OTHER|||||||0.38|||||||ANCOVA|Changes from baseline to 16 weeks were regressed on the baseline measurement.||The null hypothesis was that the changes in total body fat-free mass in response to resistance exercise training would not be different among the groups. The expected difference in fat-free mass between the Acetaminophen and Placebo groups was 1.8 +/- 1.0% with a 3.6 +/1 1.0% increase in fat-free mass in the Placebo group. The study was designed to achieve 96% power at the 0.05 level with 10 men in the acetaminophen and placebo groups.||||0.38
71932763|NCT01083901|143386386|SUPERIORITY_OR_OTHER|||||||0.23|||||||ANCOVA|The change in fat mass was regressed on the baseline measure.||||||0.23
71932764|NCT01083901|143386387|SUPERIORITY_OR_OTHER|||||||0.3|||||||ANCOVA|Change in strength was regressed on baseline measures.||||||0.30
71932765|NCT01083901|143386388|SUPERIORITY_OR_OTHER|||||||0.37|||||||ANCOVA|Changes in strength were regressed on the baseline measure.||||||0.37
71932766|NCT01625286|143386426|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.8||||0.308|TWO_SIDED|80.0|0.6|1.06||2-sided p-value|Regression, Cox|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.06|0.60|0.308
71932767|NCT01625286|143386427|SUPERIORITY||Mean Difference (Final Values)|-8.9||||0.081|TWO_SIDED|80.0|-17.1|-0.8||1-sided p-value|ANCOVA|||||-0.8|-17.1|0.081
71932768|NCT01625286|143386433|SUPERIORITY||Odds Ratio (OR)|1.53||||0.139|TWO_SIDED|80.0|0.93|2.54||1-sided p-value|Regression, Logistic|including treatment and PIK3CA status as factors/covariates||||2.54|0.93|0.139
71932769|NCT01625286|143386434|SUPERIORITY|A hazard ratio \< 1 favours AZD5363|Hazard Ratio (HR)|0.77||||0.482|TWO_SIDED|80.0|0.48|1.24||2-sided p-value|Log Rank|Cox PH model including treatment and PIK3CA status as factors/covariates||||1.24|0.48|0.482
71932770|NCT00828516|143386471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_DEVIATION|0.96|<|0.001||95.0||||This was not adjusted for multiple comparisons|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|There will be no improvement in MYMOP profile score after 6 acupuncture treatments.||||<0.001
71932771|NCT00828516|143386472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|STANDARD_DEVIATION|0.94|<|0.001||95.0||||There will be no improvement in MYMOP profile score after 12 treatments|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|||||<0.001
71932772|NCT04583592|143386477|SUPERIORITY|||||||0.787||||||\<0.05|Chi-squared|||||||0.787
71932773|NCT01164137|143386499|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.87|TWO_SIDED|95.0|-0.98|0.84|||t-test, 2 sided|||||.84|-.98|.87
71932774|NCT01164137|143386500|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.63||||0.32|TWO_SIDED|95.0|-0.62|1.88|||t-test, 2 sided|||||1.88|-.62|.32
71932775|NCT01164137|143386501|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.21||||0.18|TWO_SIDED|95.0|-0.57|3.01|||t-test, 2 sided|||||3.01|-.57|.18
71932776|NCT01164137|143386502|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.71||||0.11|TWO_SIDED|95.0|-0.39|3.81|||t-test, 2 sided|||||3.81|-.39|.11
71932777|NCT01164137|143386503|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.85||||0.13|TWO_SIDED|95.0|-0.56|4.27|||t-test, 2 sided|||||4.27|-.56|.13
71932778|NCT04523831|143386504|SUPERIORITY||Cox Proportional Hazard|0.53|||<|0.03|TWO_SIDED|95.0|0.3|0.96|||Regression, Linear|||||0.96|0.30|<0.03
71932779|NCT04523831|143386505|SUPERIORITY||Cox Proportional Hazard|0.51|||<|0.004|TWO_SIDED|95.0|0.32|0.8|||Regression, Logistic|||||0.80|0.32|<0.004
71932780|NCT04523831|143386506|SUPERIORITY||Cox Proportional Hazard|0.45|||<|0.013|TWO_SIDED|95.0|0.23|0.85|||Regression, Logistic|||||0.85|0.23|<0.013
71932781|NCT04523831|143386507|SUPERIORITY||Cox Proportional Hazard|0.58|||<|0.001|TWO_SIDED|95.0|0.44|0.81|||Regression, Logistic|||||0.81|0.44|<0.001
71932782|NCT02367781|143386522|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.639|||<|0.0001|TWO_SIDED|95.0|0.536|0.763|||Log Rank|||||0.763|0.536|<.0001
71932783|NCT02367781|143386523|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.788||||0.0298|TWO_SIDED|95.0|0.636|0.977|||Log Rank|||||0.977|0.636|0.0298
71932784|NCT02367781|143386524|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.647|||<|0.0001|TWO_SIDED|95.0|0.545|0.768|||Log Rank|||ITT Population||0.768|0.545|<0.0001
71932785|NCT02367781|143386524|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.561|||<|0.0001|TWO_SIDED|95.0|0.432|0.728|||Log Rank|||TC1/2/3 or IC1/2/3-WT ITT Population||0.728|0.432|<0.0001
71932786|NCT02367781|143386524|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.549|||<|0.0001|TWO_SIDED|95.0|0.425|0.708|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.708|0.425|<0.0001
71932787|NCT02367781|143386525|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.837||||0.0732|TWO_SIDED|95.0|0.689|1.017|||Log Rank|||||1.017|0.689|0.0732
71932788|NCT02367781|143386526|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.752||||0.083|TWO_SIDED|95.0|0.545|1.039|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||1.039|0.545|0.0830
71932789|NCT02367781|143386526|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.746||||0.0813|TWO_SIDED|95.0|0.536|1.038|||Log Rank|||TC1/2/3 or IC1/2/3 WT ITT Population||1.038|0.536|0.0813
71932790|NCT02367781|143386527|SUPERIORITY|Stratified Analysis|Difference in Response Rate|19.21|||<|0.0001|TWO_SIDED|95.0|11.05|27.37|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|||27.37|11.05|<.0001
71932791|NCT02367781|143386528|SUPERIORITY|Unstratified Analysis|Difference in Response Rate|16.89|||<|0.0001|TWO_SIDED|95.0|8.9|24.88|||Cochran-Mantel-Haenszel||Wald with Continuity Correction|ITT Population||24.88|8.90|<.0001
71932792|NCT02367781|143386528|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.22|||||TWO_SIDED|95.0|1.38|3.56||||||TC1/2/3 or IC1/2/3 ITT WT Population||3.56|1.38|
71932793|NCT02367781|143386528|SUPERIORITY|Stratified Analysis|Odds Ratio (OR)|2.21||||0.0007|TWO_SIDED|95.0|1.39|3.51|||Cochran-Mantel-Haenszel|||TC1/2/3 or IC1/2/3 ITT Population||3.51|1.39|0.0007
71932794|NCT02367781|143386529|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.614||||0.0002|TWO_SIDED|95.0|0.473|0.797|||Log Rank|||ITT Population||0.797|0.473|0.0002
71932795|NCT02367781|143386529|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.458|0.785|||Log Rank|||ITT-WT Population||0.785|0.458|0.0002
71932796|NCT02367781|143386529|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.548||||0.0011|TWO_SIDED|95.0|0.379|0.791|||Log Rank|||TC1/2/3 or IC1/2/3 ITT Population||0.791|0.379|0.0011
71932797|NCT02367781|143386529|SUPERIORITY|Unstratified Analysis|Hazard Ratio (HR)|0.551||||0.0014|TWO_SIDED|95.0|0.381|0.798|||Log Rank|||TC1/2/3 or IC1/2/3 ITT WT Population||0.798|0.381|0.0014
71932798|NCT02367781|143386530|SUPERIORITY||Difference in Event Free Rate|7.46||||0.0647|TWO_SIDED|95.0|-0.45|15.37|||Z-test|||Event Free Rate (%) at Year 1 ITT WT Population||15.37|-0.45|0.0647
71932799|NCT02367781|143386530|SUPERIORITY||Difference in Event Free Rate|8.07||||0.0516|TWO_SIDED|95.0|-0.06|16.19|||Z-test|||Event Free Rate (%) at Year 2 ITT WT Population||16.19|-0.06|0.0516
71932800|NCT02367781|143386530|SUPERIORITY||Difference in Event Free Rate|7.19||||0.0683|TWO_SIDED|95.0|-0.54|14.91|||Z-test|||Event Free Rate (%) at Year 1 ITT Population||14.91|-0.54|0.0683
71932801|NCT02367781|143386530|SUPERIORITY||Difference in Event Free Rate|7.53||||0.0625|TWO_SIDED|95.0|-0.39|15.44|||Z-test|||Event Free Rate (%) at Year 2 ITT Population||15.44|-0.39|0.0625
71932802|NCT02367781|143386531|SUPERIORITY||Difference in Event Free Rate|6.69||||0.2385|TWO_SIDED|95.0|-4.44|17.83|||Z-test|||Event Free Rate (%) at Year 1 TC1/2/3 or IC1/2/3 ITT||17.83|-4.44|0.2385
71932803|NCT02367781|143386531|SUPERIORITY||Difference in Event Free Rate|8.64||||0.271|TWO_SIDED|95.0|-6.75|24.03|||Z-test|||Event Free Rate (%) at Year 2 TC1/2/3 or IC1/2/3 ITT||24.03|-6.75|0.2710
71932804|NCT02367781|143386531|SUPERIORITY||Difference in Event Free Rate|6.34||||0.2733|TWO_SIDED|95.0|-5.0|17.67|||Z-test|||Event Free Rate (%) Year 1 TC1/2/3 or IC1/2/3 ITT WT||17.67|-5.00|0.2733
71932805|NCT02367781|143386531|SUPERIORITY||Difference in Event Free Rate|8.69||||0.2909|TWO_SIDED|95.0|-7.44|24.81|||Z-test|||Event Free Rate (%) Year 2 TC1/2/3 or IC1/2/3 ITT WT||24.81|-7.44|0.2909
71932806|NCT02367781|143386532|SUPERIORITY|Stratified Analysis|Hazard Ratio (HR)|0.893||||0.3342|TWO_SIDED|95.0|0.711|1.123|||Log Rank|||||1.123|0.711|0.3342
71932807|NCT02623426|143386540|SUPERIORITY||Ratio of the proportion of baseline|1.36|||<|0.001|TWO_SIDED|95.0|1.19|1.56||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Methotrexate/Ozurdex). Values greater than 1 indicate less reduction in retinal thickness in the Methotrexate treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for Methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.56|1.19|<0.001
71932808|NCT02623426|143386540|SUPERIORITY||Ratio of the proportion of BL|1.22||||0.012|TWO_SIDED|95.0|1.04|1.43||A Bonferroni correction was used to adjust for the co-primary hypotheses;a two-sided type I error rate of 0.05/2 = 0.025 was used to determine statistical significance for the two pairwise comparisons (Ozurdex vs Methotrexate and Ozurdex vs Lucentis)|mixed effects model||The treatment effect is the ratio of the proportions of baseline retinal thickness (Lucentis/Ozurdex) at 12 weeks. Values greater than 1 indicate less reduction in retinal thickness in the Lucentis treated group compared to Ozurdex|A sample size of 240 was calculated to provide 91% power to detect a 25% reduction for Ozurdex, a 38% reduction for methotrexate and Lucentis assuming a standard deviation of 0.33, 25% with bilateral disease, between-eye correlation of 0.4, 10% loss to follow-up, and a two-sided type 1 error rate of 0.025 for each pairwise comparison.||1.43|1.04|0.012
71932809|NCT05166421|143386564|OTHER||Geometric mean ratio|0.938|||||TWO_SIDED|90.0|0.8458|1.0403||||||Statistical Comparison of AUCinf of AZD7442||1.0403|0.8458|
71932810|NCT05166421|143386564|OTHER||Geometric mean ratio|0.9968|||||TWO_SIDED|90.0|0.898|1.1066||||||Statistical Comparison of AUCinf of AZD7442||1.1066|0.8980|
71932811|NCT05166421|143386564|OTHER||Geometric mean ratio|1.0627|||||TWO_SIDED|90.0|0.9579|1.179||||||Statistical Comparison of AUCinf of AZD7442||1.1790|0.9579|
71932812|NCT05166421|143386564|OTHER||Geometric mean ratio|0.8992|||||TWO_SIDED|90.0|0.8107|0.9974||||||Statistical Comparison of AUCinf of AZD8895||0.9974|0.8107|
71932813|NCT05166421|143386564|OTHER||Geometric mean ratio|0.9826|||||TWO_SIDED|90.0|0.8854|1.0905||||||Statistical Comparison of AUCinf of AZD8895||1.0905|0.8854|
71932814|NCT05166421|143386564|OTHER||Geometric mean ratio|1.0928|||||TWO_SIDED|90.0|0.9853|1.212||||||Statistical Comparison of AUCinf of AZD8895||1.2120|0.9853|
71932815|NCT05166421|143386564|OTHER||Geometric mean ratio|1.0039|||||TWO_SIDED|90.0|0.9029|1.1161||||||Statistical Comparison of AUCinf of AZD1061||1.1161|0.9029|
71932816|NCT05166421|143386564|OTHER||Geometric mean ratio|1.0336|||||TWO_SIDED|90.0|0.9288|1.1503||||||Statistical Comparison of AUCinf of AZD1061||1.1503|0.9288|
71932817|NCT05166421|143386564|OTHER||Geometric mean ratio|1.0296|||||TWO_SIDED|90.0|0.9258|1.1451||||||Statistical Comparison of AUCinf of AZD1061||1.1451|0.9258|
71932818|NCT05166421|143386565|OTHER||Geometric mean ratio|0.9418|||||TWO_SIDED|90.0|0.8512|1.0421||||||Statistical Comparison of AUClast of AZD7442||1.0421|0.8512|
71932819|NCT05166421|143386565|OTHER||Geometric mean ratio|0.9973|||||TWO_SIDED|90.0|0.9004|1.1046||||||Statistical Comparison of AUClast of AZD7442||1.1046|0.9004|
71932820|NCT05166421|143386565|OTHER||Geometric mean ratio|1.0589|||||TWO_SIDED|90.0|0.9559|1.173||||||Statistical Comparison of AUClast of AZD7442||1.1730|0.9559|
71932821|NCT05166421|143386565|OTHER||Geometric mean ratio|0.8812|||||TWO_SIDED|90.0|0.7933|0.9788||||||Statistical Comparison of AUClast of AZD8895||0.9788|0.7933|
71932822|NCT05166421|143386565|OTHER||Geometric mean ratio|0.96|||||TWO_SIDED|90.0|0.8633|1.0674||||||Statistical Comparison of AUClast of AZD8895||1.0674|0.8633|
71932823|NCT05166421|143386565|OTHER||Geometric mean ratio|1.0894|||||TWO_SIDED|90.0|0.9796|1.2116||||||Statistical Comparison of AUClast of AZD8895||1.2116|0.9796|
71932824|NCT05166421|143386565|OTHER||Geometric mean ratio|1.0065|||||TWO_SIDED|90.0|0.9061|1.118||||||Statistical Comparison of AUClast of AZD1061||1.1180|0.9061|
71932825|NCT05166421|143386565|OTHER||Geometric mean ratio|1.0293|||||TWO_SIDED|90.0|0.9257|1.1446||||||Statistical Comparison of AUClast of AZD1061||1.1446|0.9257|
71932826|NCT05166421|143386565|OTHER||Geometric mean ratio|1.0227|||||TWO_SIDED|90.0|0.9196|1.1373||||||Statistical Comparison of AUClast of AZD1061||1.1373|0.9196|
71932827|NCT05166421|143386566|OTHER||Geometric mean ratio|1.0308|||||TWO_SIDED|90.0|0.9451|1.1243||||||Statistical Comparison of Cmax of AZD7442||1.1243|0.9451|
71932828|NCT05166421|143386566|OTHER||Geometric mean ratio|0.993|||||TWO_SIDED|90.0|0.9112|1.0822||||||Statistical Comparison of Cmax of AZD7442||1.0822|0.9112|
71932829|NCT05166421|143386566|OTHER||Geometric mean ratio|0.9634|||||TWO_SIDED|90.0|0.8833|1.0507||||||Statistical Comparison of Cmax of AZD7442||1.0507|0.8833|
71932830|NCT05166421|143386566|OTHER||Geometric mean ratio|0.9701|||||TWO_SIDED|90.0|0.8894|1.0582||||||Statistical Comparison of Cmax of AZD8895||1.0582|0.8894|
71932831|NCT05166421|143386566|OTHER||Geometric mean ratio|0.9629|||||TWO_SIDED|90.0|0.8835|1.0494||||||Statistical Comparison of Cmax of AZD8895||1.0494|0.8835|
71932832|NCT05166421|143386566|OTHER||Geometric mean ratio|0.9926|||||TWO_SIDED|90.0|0.91|1.0826||||||Statistical Comparison of Cmax of AZD8895||1.0826|0.9100|
71932833|NCT05166421|143386566|OTHER||Geometric mean ratio|1.0976|||||TWO_SIDED|90.0|0.9992|1.2057||||||Statistical Comparison of Cmax of AZD1061||1.2057|0.9992|
71932834|NCT05166421|143386566|OTHER||Geometric mean ratio|1.0195|||||TWO_SIDED|90.0|0.929|1.119||||||Statistical Comparison of Cmax of AZD1061||1.1190|0.9290|
71932835|NCT05166421|143386566|OTHER||Geometric mean ratio|0.9289|||||TWO_SIDED|90.0|0.8457|1.0203||||||Statistical Comparison of Cmax of AZD1061||1.0203|0.8457|
71932836|NCT04084028|143386578|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
71932837|NCT04084028|143386579|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71932838|NCT04084028|143386580|SUPERIORITY|||||||0.91|||||||Mixed Models Analysis|||||||0.91
71932839|NCT04084028|143386581|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|||||||.19
71932840|NCT04084028|143386582|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||||||.77
71932841|NCT04084028|143386583|SUPERIORITY|||||||0.06|||||||Mixed Models Analysis|||||||.06
71932842|NCT00681824|143386600|SUPERIORITY_OR_OTHER|||||||0.7159||95.0|||||likelihood ratio of chi squared test|||||||0.7159
71932843|NCT02595528|143386632|SUPERIORITY||Least Squares (LS)|-2.5543||||0.0029|||||||Mixed model for repeated measures|||AGN-190584 Quadratic||||0.0029
71932844|NCT02595528|143386632|SUPERIORITY||Least Squares (LS)|6.6961|||<|0.0001|||||||Mixed model for repeated measures|||AGN-190584 Linear||||<0.0001
71932845|NCT02595528|143386632|SUPERIORITY||Least Squares (LS)|-69.89||||0.4126|||||||Mixed model for repeated measures|||AGN-199201 Quadratic||||0.4126
71932846|NCT02595528|143386632|SUPERIORITY||Least Squares (LS)|10.5017||||0.3752|||||||Mixed model for repeated measures|||AGN-199201 Linear||||0.3752
71932847|NCT02292433|143386659|SUPERIORITY_OR_OTHER||LS Mean Difference|-19.96|STANDARD_ERROR_OF_MEAN|4.841||0.0032|TWO_SIDED|90.0|-28.93|-10.98|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-10.98|-28.93|0.0032
71932848|NCT02292433|143386659|SUPERIORITY_OR_OTHER||LS Mean Difference|-41.06|STANDARD_ERROR_OF_MEAN|3.172|<|0.0001|TWO_SIDED|90.0|-46.77|-35.35|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-35.35|-46.77|<0.0001
71932849|NCT02292433|143386660|SUPERIORITY_OR_OTHER||LS Mean Difference|-12.18|STANDARD_ERROR_OF_MEAN|2.851||0.0006|TWO_SIDED|90.0|-17.16|-7.21|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-7.21|-17.16|0.0006
71932850|NCT02292433|143386660|SUPERIORITY_OR_OTHER||LS Mean Difference|-25.81|STANDARD_ERROR_OF_MEAN|2.821|<|0.0001|TWO_SIDED|90.0|-30.73|-20.88|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-20.88|-30.73|<0.0001
71932851|NCT02292433|143386661|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.521|STANDARD_ERROR_OF_MEAN|0.7237||0.0447|TWO_SIDED|90.0|-2.752|-0.29|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.290|-2.752|0.0447
71932852|NCT02292433|143386661|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.949|STANDARD_ERROR_OF_MEAN|0.7249||0.0119|TWO_SIDED|90.0|-3.183|-0.716|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.716|-3.183|0.0119
71932853|NCT02292433|143386661|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.967|STANDARD_ERROR_OF_MEAN|2.3324||0.6873|TWO_SIDED|90.0|-5.195|3.261|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||3.261|-5.195|0.6873
71932854|NCT02292433|143386661|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.439|STANDARD_ERROR_OF_MEAN|0.9533||0.0659|TWO_SIDED|90.0|-4.502|-0.377|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.377|-4.502|0.0659
71932855|NCT02292433|143386661|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.358|STANDARD_ERROR_OF_MEAN|1.5994||0.4031|TWO_SIDED|90.0|-4.079|1.363|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||1.363|-4.079|0.4031
71932856|NCT02292433|143386661|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.766|STANDARD_ERROR_OF_MEAN|1.5951||0.0254|TWO_SIDED|90.0|-6.479|-1.052|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-1.052|-6.479|0.0254
71932857|NCT02292433|143386662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.069||0.0067|TWO_SIDED|90.0|-0.33|-0.09|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.09|-0.33|0.0067
71932858|NCT02292433|143386662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.071||0.0282|TWO_SIDED|90.0|-0.29|-0.05|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||-0.05|-0.29|0.0282
71932859|NCT02292433|143386662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.03|STANDARD_ERROR_OF_MEAN|0.118||0.7877|TWO_SIDED|90.0|-0.18|0.25|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.18|0.7877
71932860|NCT02292433|143386662|SUPERIORITY_OR_OTHER||LS Mean Difference|0.11|STANDARD_ERROR_OF_MEAN|0.156||0.5064|TWO_SIDED|90.0|-0.17|0.39|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.39|-0.17|0.5064
71932861|NCT02292433|143386662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.293||0.4072|TWO_SIDED|90.0|-0.75|0.25|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.25|-0.75|0.4072
71932862|NCT02292433|143386662|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.45|STANDARD_ERROR_OF_MEAN|0.295||0.1422|TWO_SIDED|90.0|-0.95|0.06|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.||0.06|-0.95|0.1422
71932863|NCT03101293|143386663|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).|LS Mean Ratio|1.343||||0.0058|TWO_SIDED|90.0|1.146|1.574|||ANOVA|||||1.574|1.146|0.0058
71932864|NCT03101293|143386664|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.121||||0.1763|TWO_SIDED|90.0|0.969|1.298|||ANOVA|||||1.298|0.969|0.1763
71690848|NCT03272347|142897853|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|9.6|||||TWO_SIDED|95.0|-3.8|23.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||23.0|-3.8|
71932865|NCT03101293|143386665|EQUIVALENCE|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.154||||0.2745|TWO_SIDED|90.0|0.929|1.433|||ANOVA|||||1.433|0.929|0.2745
71690849|NCT03272347|142897853|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|0.2|||||TWO_SIDED|95.0|-16.0|16.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||16.3|-16.0|
71932866|NCT01430182|143386736|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 1 sided|unpaired||||||0.37
71932867|NCT03137082|143386754|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<0.03
71932868|NCT03137082|143386755|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
71932869|NCT03137082|143386757|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71932870|NCT03137082|143386758|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71932871|NCT03137082|143386759|SUPERIORITY|||||||0.5|||||||Mixed Models Analysis|||||||0.5
71932872|NCT03137082|143386760|SUPERIORITY||||||<|0.03|||||||Mixed Models Analysis|||||||<.03
71932873|NCT03137082|143386761|SUPERIORITY|||||||0.1|||||||Mixed Models Analysis|||||||0.1
71932874|NCT03137082|143386762|SUPERIORITY||||||<|0.3|||||||Mixed Models Analysis|||||||<0.3
71932875|NCT03137082|143386763|SUPERIORITY|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71932876|NCT03137082|143386764|SUPERIORITY|||||||0.4|||||||Mixed Models Analysis|||||||0.4
71932877|NCT03137082|143386765|SUPERIORITY|||||||0.08|||||||Mixed Models Analysis|||||||0.08
71932878|NCT03137082|143386766|SUPERIORITY|||||||0.2|||||||Mixed Models Analysis|||||||0.2
71932879|NCT00417027|143386767|SUPERIORITY_OR_OTHER||||||>|0.05||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||>0.05
71932880|NCT00417027|143386767|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.005
71932881|NCT00417027|143386767|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)|||||||0.02
71932882|NCT00417027|143386768|SUPERIORITY_OR_OTHER|||||||0.54||95.0|||||Kruskal-Wallis|||||||0.54
71932883|NCT00417027|143386769|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Kruskal-Wallis|||||||0.32
71932884|NCT00417027|143386770|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||0.69
71932885|NCT00417027|143386771|SUPERIORITY_OR_OTHER|||||||0.72||95.0||||Analysis applies to all rows.|Chi-squared, Corrected|||Analysis apply to all rows. Only 1 comparison was made between the groups in distribution of number of bolus doses.||||0.72
71932886|NCT00417027|143386772|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||Kruskal-Wallis|||||||0.41
71932887|NCT00417027|143386773|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||Kruskal-Wallis|||||||0.85
71932888|NCT01017029|143386814|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.482||||0.1043|TWO_SIDED|95.0|0.922|2.383|||Regression, Cox|||||2.383|0.922|0.1043
71932889|NCT01017029|143386816|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.847||||0.0398|TWO_SIDED|95.0|1.029|3.315|||Regression, Cox|||||3.315|1.029|0.0398
71932890|NCT01017029|143386818|SUPERIORITY_OR_OTHER|||||||0.0234|||||||Fisher Exact|||CMV infections||||0.0234
71932891|NCT01017029|143386819|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.403||||0.1966|TWO_SIDED|95.0|0.839|2.347|||Regression, Cox|||||2.347|0.839|0.1966
71932892|NCT02660385|143386845|SUPERIORITY||Effect Size|-0.6||||0.0002|TWO_SIDED||||||Generalized Linear Mixed Model (GLMM)|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0002
71932893|NCT02660385|143386846|SUPERIORITY|||||||0.0723||||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0723
71932894|NCT02660385|143386847|SUPERIORITY||effect size|0.42||||0.011|TWO_SIDED||||||GLMM|GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.||||||0.0110
71932895|NCT02660385|143386848|SUPERIORITY||effect size|-0.7|||<|0.0001|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||<0.0001
71932896|NCT02660385|143386849|SUPERIORITY||effect size|-0.12||||0.4356|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4356
71932897|NCT02660385|143386850|SUPERIORITY|||||||0.0148||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0148
71932898|NCT02660385|143386851|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71932899|NCT02660385|143386852|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71932900|NCT02660385|143386853|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71932901|NCT02660385|143386854|SUPERIORITY|||||||0.6358||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.6358
71932902|NCT02660385|143386855|SUPERIORITY||effect size|0.35||||0.0318|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0318
71932903|NCT02660385|143386856|SUPERIORITY|||||||0.2722||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2722
71932904|NCT02660385|143386857|SUPERIORITY||effect size|-0.27||||0.0954|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0954
71932905|NCT02660385|143386858|SUPERIORITY|||||||0.4222||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.4222
71932906|NCT02660385|143386859|SUPERIORITY||effect size|0.09||||0.5781|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.5781
71932907|NCT02660385|143386860|SUPERIORITY|||||||0.1238||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1238
71932908|NCT02660385|143386861|SUPERIORITY||effect size|-0.3||||0.0558|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0558
71932909|NCT02660385|143386862|SUPERIORITY|||||||0.023||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0230
71932910|NCT02660385|143386863|SUPERIORITY||effect size|0.06||||0.4597|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.4597
71932911|NCT02660385|143386864|SUPERIORITY|||||||0.1943||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.1943
71932912|NCT02660385|143386865|SUPERIORITY||effect size|-0.23||||0.0027|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0027
71690850|NCT03272347|142897854|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.1|||||TWO_SIDED|95.0|-12.2|24.4|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.4|-12.2|
71690851|NCT03272347|142897854|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|6.2|||||TWO_SIDED|95.0|-12.2|24.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||24.6|-12.2|
71690852|NCT03272347|142897854|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.1|||||TWO_SIDED|95.0|-27.1|14.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||14.8|-27.1|
71690853|NCT03272347|142897855|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.6|||||TWO_SIDED|95.0|-15.7|20.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.5|-15.7|
71690854|NCT03272347|142897855|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|2.9|||||TWO_SIDED|95.0|-15.0|20.8|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.8|-15.0|
71690855|NCT03272347|142897855|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-9.7|||||TWO_SIDED|95.0|-29.4|10.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||10.1|-29.4|
71690856|NCT03272347|142897856|OTHER|Based on Miettinen \& Nurminen method|Difference in %|0.2|||||TWO_SIDED|95.0|-13.4|14.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||14.5|-13.4|
71690857|NCT03272347|142897856|OTHER|Based on Miettinen \& Nurminen method|Difference in %|-3.2|||||TWO_SIDED|95.0|-16.4|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-16.4|
71690858|NCT03272347|142897856|OTHER|Based on Miettinen \& Nurminen method|Difference in %|3.2|||||TWO_SIDED|95.0|-10.8|18.1|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||18.1|-10.8|
71690859|NCT03272347|142897857|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-9.7|||||TWO_SIDED|95.0|-26.1|6.6|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||6.6|-26.1|
71690860|NCT03272347|142897857|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-6.2|||||TWO_SIDED|95.0|-21.5|9.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||9.1|-21.5|
71690861|NCT03272347|142897857|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-7.5|||||TWO_SIDED|95.0|-23.9|8.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||8.8|-23.9|
71690862|NCT03272347|142897858|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|2.2|||||TWO_SIDED|95.0|-23.4|27.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||27.7|-23.4|
71932913|NCT02660385|143386866|SUPERIORITY|||||||0.0792||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0792
71932914|NCT02660385|143386867|SUPERIORITY||effect size|0.13||||0.0656|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.0656
71932915|NCT02660385|143386868|SUPERIORITY|||||||0.2174||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.2174
71932916|NCT02660385|143386869|SUPERIORITY||effect size|0.07||||0.7028|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7028
71932917|NCT02660385|143386870|SUPERIORITY|||||||0.0509||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0509
71932918|NCT02660385|143386871|SUPERIORITY||Mean Difference (Final Values)|275.0|STANDARD_ERROR_OF_MEAN|1525.0||0.955|TWO_SIDED|95.0|-3288.0|2739.0|||t-test, 2 sided|||||2739|-3288|0.955
71932919|NCT02660385|143386872|SUPERIORITY|||||||0.013||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.0130
71932920|NCT02660385|143386873|SUPERIORITY||effect size|-0.05||||0.7496|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.7496
71932921|NCT02660385|143386874|SUPERIORITY||effect size|0.06||||0.3821|TWO_SIDED|||||GLMM with random intercepts and unstructured covariances with changes within groups and time-group interactions to compare the intervention effects.|GLMM|||||||0.3821
71932922|NCT02660385|143386875|SUPERIORITY|||||||0.7204||||||The p value is from the group X time interaction adjusted at 12 months based on the false discovery rate|Mixed Models Analysis|||||||0.7204
71932923|NCT03547531|143386888|OTHER||||||>|0.05|||||||t-test, 2 sided|independent t-test||Null hypothesis: the mean of plaque index between groups are not different|the statistical analysis used in this study is independent t-test|||>0.05
71932924|NCT03547531|143386889|OTHER|this data is analyzed using independent t-test|||||>|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||>0.05
71932925|NCT03547531|143386890|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of plaque index between groups|this data is analyzed using independent t-test|||<0.05
71932926|NCT03547531|143386891|OTHER|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test|||<0.05
71932927|NCT02117479|143386906|OTHER||Hazard Ratio (HR)|0.969|||||TWO_SIDED|95.0|0.747|1.256||||||||1.256|0.747|
71690863|NCT03272347|142897858|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-3.7|||||TWO_SIDED|95.0|-29.6|22.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||22.1|-29.6|
71690864|NCT03272347|142897858|OTHER|The 95% CIs were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA ≤100,000 or \>100,000 copies/mL).|Treatment Difference|-1.3|||||TWO_SIDED|95.0|-27.7|25.2|||||Islatravir minus DOR/3TC/TDF|Treatment difference in percent response||25.2|-27.7|
71690865|NCT03272347|142897860|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|78.4|||||TWO_SIDED|95.0|18.8|138.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||138.1|18.8|
71690866|NCT03272347|142897860|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|50.7|||||TWO_SIDED|95.0|-31.7|133.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||133.1|-31.7|
71690867|NCT03272347|142897860|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.8|||||TWO_SIDED|95.0|-63.0|64.7|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.7|-63.0|
71690868|NCT03272347|142897861|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-74.1|75.3|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||75.3|-74.1|
71690869|NCT03272347|142897861|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|1.5|||||TWO_SIDED|95.0|-70.7|73.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||73.8|-70.7|
71932928|NCT02117479|143386907|OTHER||Hazard Ratio (HR)|1.056|||||TWO_SIDED|95.0|0.827|1.348||||||||1.348|0.827|
71932929|NCT02981602|143386953|OTHER|||||||0.116||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.116
71932930|NCT02981602|143386953|OTHER||||||<|0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||<0.001
71932931|NCT02981602|143386953|OTHER|||||||0.573||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.573
71690870|NCT03272347|142897861|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-80.8|||||TWO_SIDED|95.0|-165.6|4.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||4.0|-165.6|
71690871|NCT03272347|142897862|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-25.5|||||TWO_SIDED|95.0|-134.8|83.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||83.8|-134.8|
71690872|NCT03272347|142897862|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.6|||||TWO_SIDED|95.0|-212.1|-3.1|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-3.1|-212.1|
71690873|NCT03272347|142897862|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-132.4|||||TWO_SIDED|95.0|-242.9|-21.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||-21.9|-242.9|
71690874|NCT03272347|142897863|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-65.6|||||TWO_SIDED|95.0|-195.3|64.0|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||64.0|-195.3|
71690875|NCT03272347|142897863|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-61.0|||||TWO_SIDED|95.0|-188.7|66.8|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||66.8|-188.7|
71690876|NCT03272347|142897863|OTHER|The 95% CI for mean difference in CD4 change was based on t-distribution.|Treatment Difference|-107.1|||||TWO_SIDED|95.0|-231.2|16.9|||||Islatravir minus DOR/3TC/TDF|Treatment difference in T-cell count||16.9|-231.2|
71690877|NCT03272347|142897865|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|4.9|||||TWO_SIDED|95.0|-20.3|29.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||29.6|-20.3|
71690878|NCT03272347|142897865|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|9.5|||||TWO_SIDED|95.0|-15.4|33.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||33.5|-15.4|
71690879|NCT03272347|142897865|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-5.3|||||TWO_SIDED|95.0|-30.6|20.7|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.7|-30.6|
71932932|NCT02981602|143386954|OTHER|||||||0.609||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.609
71932933|NCT02981602|143386954|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
71932934|NCT02981602|143386955|OTHER|Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group||||||0.245|||||||ANCOVA|||||||0.245
71932935|NCT02981602|143386955|OTHER|||||||0.001||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.001
71932936|NCT02981602|143386955|OTHER|||||||0.762||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.762
71932937|NCT02981602|143386956|OTHER|||||||0.141||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.141
71932938|NCT02981602|143386956|OTHER|||||||0.081||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.081
71932939|NCT02981602|143386956|OTHER|||||||0.616||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.616
71932940|NCT02981602|143386959|OTHER|||||||0.763||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.763
71932941|NCT02981602|143386959|OTHER|||||||0.804||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.804
71932942|NCT02981602|143386960|OTHER|||||||0.372||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.372
71932943|NCT02981602|143386960|OTHER|||||||0.954||||||Baseline was the covariate and treatment group as a factor for the comparison between GSK3228836 and placebo group|ANCOVA|||||||0.954
71932944|NCT00386100|143386973|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49|||<|0.0001|TWO_SIDED|95.0|-0.669|-0.305||No adjustment for multiple comparisons|ANCOVA|ANCOVA with terms for treatment, region, gender, and baseline value with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.305|-0.669|<0.0001
71932945|NCT00386100|143386974|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5|||<|0.0001|TWO_SIDED|95.0|-0.69|-0.3||No adjustment for multiple comparisons|Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.30|-0.69|<0.0001
71932946|NCT00386100|143386975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.0046|TWO_SIDED|95.0|1.18|2.46||Hb1AC \<= 6.5%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32.|Odds of having an HbA1c \<= 6.5% at Week 80 on Avandamet compared to Metformin.|||2.46|1.18|0.0046
71932947|NCT00386100|143386975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.59|||<|0.0001|TWO_SIDED|95.0|1.75|3.81||Hb1AC \< 7%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32|Odds of having an HbA1c \<7% at Week 80 on Avandamet compared to Metformin|||3.81|1.75|<0.0001
71932948|NCT00386100|143386976|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.15|||<|0.0001||95.0|-1.54|-0.77|||Repeated measures analysis|Terms for baseline, region, treatment, pre-screening Hb1Ac strata, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model|||-0.77|-1.54|<0.0001
71932949|NCT00386100|143386977|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.07|||<|0.001|TWO_SIDED|95.0|-1.425|-0.71||No adjustment for multiple comparisons|ANCOVA|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.710|-1.425|<0.001
71932950|NCT00386100|143386978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.47|||<|0.0001|TWO_SIDED|95.0|2.94|6.81||FPG \<=6.1 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32.|Odds of having an FPG \<=6.1 mmol/l at Week 80 on Avandamet compared to Metformin|||6.81|2.94|<0.0001
71932951|NCT00386100|143386978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.33|||<|0.0001|TWO_SIDED|95.0|2.25|4.92||FPG \<=7 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac, and baseline with LOCF from Week 32.|Odds of having an FPG \<=7 mmol/l at Week 80 on Avandamet compared to Metformin|||4.92|2.25|<0.0001
71932952|NCT00386100|143386979|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.58|||<|0.0001|TWO_SIDED|95.0|0.45|0.74|||Regression, Cox|Cox proportional hazard regression with terms for treatment, region, baseline Hb1Ac strata, and gender||||0.74|0.45|<0.0001
71932953|NCT00386100|143386980|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.97||||0.0006|TWO_SIDED|95.0|2.522|9.526||Total cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||9.526|2.522|0.0006
71932954|NCT00386100|143386980|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.71||||0.056|TWO_SIDED|95.0|2.486|15.304||LDL cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||15.304|2.486|0.056
71932955|NCT00386100|143386980|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.58||||0.072|TWO_SIDED|95.0|-0.232|5.47||HDL cholesterol. No adjustment for multiple comparison. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||5.470|-0.232|0.072
71932956|NCT00386100|143386980|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.743||||0.835|TWO_SIDED|95.0|-6.056|8.035||Triglycerides. No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||8.035|-6.056|0.835
71932957|NCT00386100|143386981|SUPERIORITY_OR_OTHER||Percent difference from metformin|102.24|||<|0.0001|TWO_SIDED|95.0|79.23|128.19||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||128.19|79.23|<0.0001
71932958|NCT00386100|143386982|SUPERIORITY_OR_OTHER||Percent difference from metformin|-8.2||||0.138|TWO_SIDED|95.0|-18.04|2.82||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||2.82|-18.04|0.1380
71932959|NCT00386100|143386983|SUPERIORITY_OR_OTHER||Percent difference from metformin|-11.308||||0.0342|TWO_SIDED|95.0|-20.617|-0.899||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||-0.899|-20.617|0.0342
71932960|NCT00386100|143386984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-33.7||||0.0042|TWO_SIDED|95.0|-56.666|-0.99||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline.|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.99|-56.666|0.0042
71932961|NCT00386100|143386985|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.229||||0.0006|TWO_SIDED|95.0|-0.359|-0.099||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model|||-0.099|-0.359|0.0006
71932962|NCT00386100|143386986|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.4||||0.7148|TWO_SIDED|95.0|-9.87|16.34||HOMA-B. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||16.34|-9.87|0.7148
71932963|NCT00386100|143386986|SUPERIORITY_OR_OTHER||percent difference from metformin|31.14|||<|0.001|TWO_SIDED|95.0|14.82|49.78||HOMA-S. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline \[BL\]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)||||49.78|14.82|<0.001
71932964|NCT00386100|143386987|SUPERIORITY_OR_OTHER||Mean Difference (Net)|80.85||||0.319|TWO_SIDED|95.0|-79.035|240.744|||Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, pre-screening Hb1AC, time, and treatment by time interaction||||240.744|-79.035|0.319
71932965|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0012|TWO_SIDED|95.0|-3.5|-0.9||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.9|-3.5|0.0012
71932966|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.6||||0.0031|TWO_SIDED|95.0|-2.7|-0.6||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-2.7|0.0031
71932967|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.0308|TWO_SIDED|95.0|-2.0|-0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-2.0|0.0308
71932968|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.0954|TWO_SIDED|95.0|-3.7|0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.3|-3.7|0.0954
71932969|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.9||||0.0015|TWO_SIDED|95.0|-4.7|-1.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.2|-4.7|0.0015
71932970|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.3||||0.0045|TWO_SIDED|95.0|-3.9|-0.7||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-3.9|0.0045
71932971|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.0005|TWO_SIDED|95.0|-3.3|-1.0||Female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-3.3|0.0005
71690880|NCT03272347|142897866|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.5|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.5|-17.9|
71932972|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.2363|TWO_SIDED|95.0|-4.6|1.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.2|-4.6|0.2363
71932973|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.3||||0.0161|TWO_SIDED|95.0|-5.9|-0.6||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-5.9|0.0161
71690881|NCT03272347|142897866|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|-3.6|||||TWO_SIDED|95.0|-17.9|8.2|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||8.2|-17.9|
71690882|NCT03272347|142897866|OTHER|Based on Miettinen \& Nurminen method.|Difference in %|3.8|||||TWO_SIDED|95.0|-11.5|20.6|||||Islatravir minus DOR/3TC/TDF|Difference in % Islatravir vs DOR/3TC/TDF||20.6|-11.5|
71932974|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.0338|TWO_SIDED|95.0|-4.9|-0.2||Postmenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.9|0.0338
71932975|NCT00386100|143386989|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.1|-1.0||Postmenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-1.0|-4.1|0.0020
71932976|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0005|TWO_SIDED|95.0|-2.3|-0.7||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.7|-2.3|0.0005
71932977|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.0||||0.011|TWO_SIDED|95.0|-1.7|-0.2||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-1.7|0.0110
71932978|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.0618|TWO_SIDED|95.0|-1.1|0.0||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-1.1|0.0618
71932979|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.3||||0.011|TWO_SIDED|95.0|-2.3|-0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.3|0.0110
71932980|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.0272|TWO_SIDED|95.0|-1.9|-0.1||Male population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.9|0.0272
71932981|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8||||0.0337|TWO_SIDED|95.0|-1.6|-0.1||Male population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.1|-1.6|0.0337
71932982|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.7||||0.0152|TWO_SIDED|95.0|-3.1|-0.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-3.1|0.0152
71932983|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.2||||0.057|TWO_SIDED|95.0|-2.4|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-2.4|0.0570
71932984|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Median Difference (Net)|-2.2||||0.0296|TWO_SIDED|95.0|-4.3|-0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.3|0.0296
71932985|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.0155|TWO_SIDED|95.0|-4.4|-0.5||Premenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.5|-4.4|0.0155
71932986|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.4||||0.587|TWO_SIDED|95.0|-1.7|1.0||Premenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.7|0.5870
71932987|NCT00386100|143386990|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.1854|TWO_SIDED|95.0|-3.6|0.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-3.6|0.1854
71932988|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.9||||0.0038|TWO_SIDED|95.0|-3.2|-0.6||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.6|-3.2|0.0038
71932989|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0134|TWO_SIDED|95.0|-2.7|-0.3||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.3|-2.7|0.0134
71932990|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.0967|TWO_SIDED|95.0|-1.5|0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.1|-1.5|0.0967
71932991|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.0512|TWO_SIDED|95.0|-3.0|0.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.0|0.0512
71932992|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.4||||0.033|TWO_SIDED|95.0|-4.6|-0.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||-0.2|-4.6|0.0330
71932993|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.0547|TWO_SIDED|95.0|-3.7|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.0|-3.7|0.0547
71932994|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.0613|TWO_SIDED|95.0|-6.3|0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-6.3|0.0613
71932995|NCT00386100|143386991|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.5||||0.1369|TWO_SIDED|95.0|-3.9|1.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.7|-3.9|0.1369
71932996|NCT00386100|143386992|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.126|TWO_SIDED|95.0|-1.7|0.2||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.2|-1.7|0.1260
71932997|NCT00386100|143386992|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.7||||0.3117|TWO_SIDED|95.0|-2.2|0.7||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.7|-2.2|0.3117
71932998|NCT00386100|143386992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.1776|TWO_SIDED|95.0|-2.2|0.4||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.4|-2.2|0.1776
71932999|NCT00386100|143386992|SUPERIORITY_OR_OTHER||Median Difference (Net)|-1.2||||0.2259|TWO_SIDED|95.0|-3.2|0.8||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-3.2|0.2259
71933000|NCT00386100|143386992|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.384|TWO_SIDED|95.0|-2.8|1.1||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-2.8|0.3840
71933001|NCT00386100|143386993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.6102|TWO_SIDED|95.0|-1.9|1.1||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.1|-1.9|0.6102
71933002|NCT00386100|143386993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.3445|TWO_SIDED|95.0|-2.9|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-2.9|0.3445
71933003|NCT00386100|143386993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.9735|TWO_SIDED|95.0|-2.4|2.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.3|-2.4|0.9735
71933004|NCT00386100|143386993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.4||||0.4861|TWO_SIDED|95.0|-5.8|2.9||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||2.9|-5.8|0.4861
71933005|NCT00386100|143386993|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.877|TWO_SIDED|95.0|-3.5|4.0||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||4.0|-3.5|0.8770
71933006|NCT00386100|143386994|SUPERIORITY_OR_OTHER||Median Difference (Net)|-0.2||||0.7015|TWO_SIDED|95.0|-1.5|1.0||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-1.5|0.7015
71933007|NCT00386100|143386994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2||||0.6767|TWO_SIDED|95.0|-0.7|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.0|-0.7|0.6767
71933008|NCT00386100|143386994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.4199|TWO_SIDED|95.0|-3.4|1.5||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||1.5|-3.4|0.4199
71933009|NCT00386100|143386994|SUPERIORITY_OR_OTHER||Median Difference (Net)|-5.5||||0.2526|TWO_SIDED|95.0|-16.4|5.4||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||5.4|-16.4|0.2526
71933010|NCT00386100|143386994|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.4153|TWO_SIDED|95.0|-1.8|0.8||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||0.8|-1.8|0.4153
71933011|NCT00386100|143386995|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.168||||0.7895|TWO_SIDED|95.0|-1.066|1.417||Overall population, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.417|-1.066|0.7895
71933012|NCT00386100|143386995|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.745||||0.4155|TWO_SIDED|95.0|-1.064|2.587||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.587|-1.064|0.4155
71933013|NCT00386100|143386995|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.452||||0.6223|TWO_SIDED|95.0|-2.253|1.382||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.382|-2.253|0.6223
71933014|NCT00386100|143386995|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.638||||0.5908|TWO_SIDED|95.0|-3.043|1.826||Premenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||1.826|-3.043|0.5908
71933015|NCT00386100|143386995|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.155||||0.9154|TWO_SIDED|95.0|-3.037|2.814||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||2.814|-3.037|0.9154
71933016|NCT00386100|143386996|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.467||||0.8682|TWO_SIDED|95.0|-14.785|20.818||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.818|-14.785|0.8682
71933017|NCT00386100|143386996|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.328||||0.974|TWO_SIDED|95.0|-18.308|23.214||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||23.214|-18.308|0.9740
71933018|NCT00386100|143386996|SUPERIORITY_OR_OTHER||Percent difference from metformin|2.986||||0.8378|TWO_SIDED|95.0|-22.997|37.735||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||37.735|-22.997|0.8378
71933019|NCT00386100|143386996|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.19||||0.7889|TWO_SIDED|95.0|-43.839|108.422||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||108.422|-43.839|0.7889
71933020|NCT00386100|143386996|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.344||||0.88|TWO_SIDED|95.0|-34.853|63.935||Postmenopausal females, Week 80. Log transformed.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||63.935|-34.853|0.8800
71933021|NCT00386100|143386997|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.2168||||0.9069|TWO_SIDED|95.0|-17.6057|24.3392||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||24.3392|-17.6057|0.9069
71933022|NCT00386100|143386997|SUPERIORITY_OR_OTHER||Percent difference from metformin|-10.1648||||0.5118|TWO_SIDED|95.0|-35.6298|25.3742||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.3742|-35.6298|0.5118
71690883|NCT01677182|142897909|SUPERIORITY_OR_OTHER||Least Squares Mean Differences|0.8|STANDARD_ERROR_OF_MEAN|0.98||0.783|TWO_SIDED|97.5|-1.4|3.0||Mixed Model Repeated Measures (MMRM) model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.0|-1.4|0.783
71933023|NCT00386100|143386997|SUPERIORITY_OR_OTHER||Percent difference from metformin|8.8777||||0.5816|TWO_SIDED|95.0|-20.2636|48.6692||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||48.6692|-20.2636|0.5816
71933024|NCT00386100|143386997|SUPERIORITY_OR_OTHER||Percent difference from metformin|-1.0031||||0.9587|TWO_SIDED|95.0|-35.928|52.959||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||52.9590|-35.9280|0.9587
71933025|NCT00386100|143386997|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.7614||||0.8337|TWO_SIDED|95.0|-34.4741|67.4901||Postmenopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||67.4901|-34.4741|0.8337
71933026|NCT00386100|143386998|SUPERIORITY_OR_OTHER||Percent difference from metformin|7.527||||0.7041|TWO_SIDED|95.0|-26.773|57.892||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||57.892|-26.773|0.7041
71933027|NCT00386100|143386998|SUPERIORITY_OR_OTHER||Percent difference from metformin|30.211||||0.6403|TWO_SIDED|95.0|-61.586|341.371||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||341.371|-61.586|0.6403
71933028|NCT00386100|143386998|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.929||||0.8474|TWO_SIDED|95.0|-17.015|25.198||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.||||25.198|-17.015|0.8474
71933029|NCT00386100|143386999|SUPERIORITY_OR_OTHER||Percent difference from metformin|5.7||||0.486|TWO_SIDED|95.0|-9.6|23.6||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.6|-9.6|0.4860
71933030|NCT00386100|143386999|SUPERIORITY_OR_OTHER||Percent difference from metformin|12.3||||0.3791|TWO_SIDED|95.0|-13.7|46.1||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||46.1|-13.7|0.3791
71933031|NCT00386100|143386999|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.0||||0.7065|TWO_SIDED|95.0|-15.3|27.6||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||27.6|-15.3|0.7065
71933032|NCT00386100|143386999|SUPERIORITY_OR_OTHER||Percent difference from metformin|32.1||||0.1381|TWO_SIDED|95.0|-9.5|92.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||92.7|-9.5|0.1381
71933033|NCT00386100|143386999|SUPERIORITY_OR_OTHER||Percent difference from metformin|-4.3||||0.7195|TWO_SIDED|95.0|-25.4|22.7||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||22.7|-25.4|0.7195
71933034|NCT00386100|143387000|SUPERIORITY_OR_OTHER||Percent difference from metformin|-3.0||||0.5595|TWO_SIDED|95.0|-12.3|7.4||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.4|-12.3|0.5595
71933035|NCT00386100|143387000|SUPERIORITY_OR_OTHER||Percent difference from metformin|1.0||||0.9125|TWO_SIDED|95.0|-15.3|20.4||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||20.4|-15.3|0.9125
71933036|NCT00386100|143387000|SUPERIORITY_OR_OTHER||Percent difference from metformin|-0.8||||0.9122|TWO_SIDED|95.0|-14.0|14.5||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.5|-14.0|0.9122
71933037|NCT00386100|143387000|SUPERIORITY_OR_OTHER||Percent difference from metformin|4.6||||0.7435|TWO_SIDED|95.0|-21.2|38.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||38.7|-21.2|0.7435
71933038|NCT00386100|143387000|SUPERIORITY_OR_OTHER||Percent difference from metformin|-7.5||||0.3897|TWO_SIDED|95.0|-23.0|11.0||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||11.0|-23.0|0.3897
71933039|NCT00386100|143387001|SUPERIORITY_OR_OTHER||Percent difference from metformin|-2.83||||0.5176|TWO_SIDED|95.0|-10.97|6.06||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||6.06|-10.97|0.5176
71933040|NCT00386100|143387001|SUPERIORITY_OR_OTHER||Percent difference from metformin|-6.26||||0.362|TWO_SIDED|95.0|-18.62|7.97||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||7.97|-18.62|0.3620
71933041|NCT00386100|143387001|SUPERIORITY_OR_OTHER||Percent difference from metformin|0.72||||0.9115|TWO_SIDED|95.0|-11.39|14.48||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||14.48|-11.39|0.9115
71933042|NCT00386100|143387001|SUPERIORITY_OR_OTHER||Percent difference from metformin|-13.51||||0.1956|TWO_SIDED|95.0|-30.35|8.31||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||8.31|-30.35|0.1956
71933043|NCT00386100|143387001|SUPERIORITY_OR_OTHER||Percent difference from metformin|3.75||||0.6749|TWO_SIDED|95.0|-13.09|23.85||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline||||23.85|-13.09|0.6749
71933044|NCT02020785|143387009|SUPERIORITY|Main analyses were intention-to-treat using mixed effects models allowing intercepts to vary for each individual. Carryover effects were examined by using treatment by assignment-order interaction terms. Pre-specified sensitivity analyses were conducted excluding patients who were non-compliant, prior to data analysis: 1st, noncompliance based on missing product pickups and follow-up visits; 2nd, suspected poor compliance (\< 250 mg difference between the higher and lower period).\]|Mean Difference (Final Values)|0.143||||0.05|TWO_SIDED|95.0|-0.025|0.34||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (14.3%, 95% CI: -2.5%, 34.0%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed 24-hour urine albumin excretion|Sample size for this study was calculated using the xsampsi module in STATA, based on a previous study with repeat 24-hour urine collections (standard deviation, 1.04). At an α level of 0.05, we anticipated that a sample size of 30 participants with mean albuminuria of 100 mg/d would result in \>80% power to detect a 13% difference in log- transformed albuminuria between the higher and lower phosphorus additive periods.||0.34|-0.025|0.05
71933045|NCT02020785|143387010|SUPERIORITY||Mean Difference (Final Values)|0.034||||0.05|TWO_SIDED|95.0|-0.059|0.136||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (3.4%, 95% CI: -5.9%, 13.6%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed fibroblast growth factor 23|||0.136|-0.059|0.05
71933046|NCT02020785|143387011|SUPERIORITY||mean difference (during each period)|-1.1||||0.05|TWO_SIDED|95.0|-4.1|1.9||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.9|-4.1|0.05
71933047|NCT02020785|143387012|SUPERIORITY||mean difference (during each period)|-0.8||||0.05|TWO_SIDED|95.0|-2.7|1.0||For each outcome, a p value \< 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis|||||1.0|-2.7|0.05
71933048|NCT02328807|143387013|OTHER||Negative biopsy rate at 6 months after R|0.667|||||TWO_SIDED|95.0|0.223|0.957|||||Two-sided exact confidence interval was calculated using Clopper-Pearson method.|This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.||0.957|0.223|
71933049|NCT00701935|143387043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|4.432||0.8252|TWO_SIDED|95.0|-9.92|7.95||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.||"The power calculation is based on a two-sided t-test and significance level of 0.05.~Hypotheses for sample size:~Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%~94 patients are needed to attain the 37 patients randomized and analyzed in each group."||7.95|-9.92|0.8252
71933050|NCT00701935|143387044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.07|STANDARD_ERROR_OF_MEAN|3.193||0.5207|TWO_SIDED|95.0|-8.53|4.39||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.||||4.39|-8.53|0.5207
71933051|NCT00701935|143387045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.71|STANDARD_ERROR_OF_MEAN|2.687||0.1755|TWO_SIDED|95.0|-9.15|1.73||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.||||1.73|-9.15|0.1755
71933052|NCT00701935|143387046|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001|TWO_SIDED|95.0|-1.19|-0.57||p-values were not adjusted for multiple comparisons.|ANCOVA|ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c||||-0.57|-1.19|<0.0001
71933053|NCT00701935|143387048|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39|STANDARD_ERROR_OF_MEAN|0.491||0.0073|TWO_SIDED|95.0|-2.38|-0.4||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.||||-0.40|-2.38|0.0073
71690884|NCT01677182|142897909|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.97||0.329|TWO_SIDED|97.5|-2.6|1.7||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.7|-2.6|0.329
71690885|NCT01677182|142897910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.5|STANDARD_ERROR_OF_MEAN|0.27||0.088|TWO_SIDED|97.5|-0.1|1.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.1|-0.1|0.088
71933054|NCT00701935|143387049|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.21|STANDARD_ERROR_OF_MEAN|0.725||0.0035|TWO_SIDED|95.0|-3.66|-0.76||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.||||-0.76|-3.66|0.0035
71933055|NCT00701935|143387052|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.248||0.4145|TWO_SIDED|95.0|-0.71|0.3||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol||||0.30|-0.71|0.4145
71933056|NCT00701935|143387053|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.279||0.4007|TWO_SIDED|95.0|-0.8|0.33||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides||||0.33|-0.80|0.4007
71933057|NCT00701935|143387054|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.7915|TWO_SIDED|95.0|-0.08|0.11||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol||||0.11|-0.08|0.7915
71933058|NCT00701935|143387055|SUPERIORITY_OR_OTHER||Ratio|3.28|STANDARD_ERROR_OF_MEAN|2.63||0.1388|TWO_SIDED|95.0|0.68|15.77||p-values were not adjusted for multiple comparisons.|Regression, Linear|Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.||Event rate per subject year was calculated for each subject : (number of events observed from a subject/exposure from a subject)\*365.25 where exposure = last post-baseline visit date - baseline visit date.||15.77|0.68|0.1388
71933059|NCT01783483|143387081|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||t-test, 2 sided|||Comparison of mean CT scan scores.||||<0.0001
71933060|NCT01783483|143387082|SUPERIORITY_OR_OTHER|||||||0.0007|||||||t-test, 2 sided|||||||0.0007
71933061|NCT01783483|143387083|SUPERIORITY_OR_OTHER|||||||0.0539|||||||t-test, 2 sided|||At Rest||||0.0539
71933062|NCT01783483|143387083|SUPERIORITY_OR_OTHER|||||||0.0015|||||||t-test, 2 sided|||After Forced Coughing||||0.0015
71933063|NCT01783483|143387084|SUPERIORITY_OR_OTHER|||||||0.2125|||||||t-test, 2 sided|||At Rest||||0.2125
71933064|NCT01783483|143387084|SUPERIORITY_OR_OTHER|||||||0.0014|||||||t-test, 2 sided|||After Forced Coughing||||0.0014
71933065|NCT01783483|143387085|SUPERIORITY_OR_OTHER|||||||0.0049|||||||t-test, 2 sided|||At Rest||||0.0049
71933066|NCT01783483|143387085|SUPERIORITY_OR_OTHER|||||||0.0183|||||||t-test, 2 sided|||After Forced Coughing||||0.0183
71933067|NCT01783483|143387086|SUPERIORITY_OR_OTHER|||||||0.6653|||||||t-test, 2 sided|||At Rest||||0.6653
71933068|NCT01783483|143387086|SUPERIORITY_OR_OTHER|||||||0.2295|||||||t-test, 2 sided|||After Forced Coughing||||0.2295
71933069|NCT01783483|143387088|SUPERIORITY_OR_OTHER|||||||0.37|||||||t-test, 2 sided|||Index (Day 0 to Hospital Discharge)||||0.370
71933070|NCT01783483|143387089|SUPERIORITY_OR_OTHER|||||||0.778|||||||t-test, 2 sided|||From Hospital Discharge to 3-week||||0.778
71690886|NCT01677182|142897910|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.642|TWO_SIDED|97.5|-0.7|0.5||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.5|-0.7|0.642
71933071|NCT01783483|143387090|SUPERIORITY_OR_OTHER|||||||0.055|||||||t-test, 2 sided|||From 3-week to 6-week post-op||||0.055
71933072|NCT01783483|143387092|SUPERIORITY_OR_OTHER|||||||0.113|||||||t-test, 2 sided|||From 3 month to 6-month post op||||0.113
71933073|NCT03056001|143387112|OTHER|Estimation only.|Rate|0.0333|||||TWO_SIDED|95.0|0.0008|0.1722|||||Confidence interval estimated using the Clopper Pearson method.|The reported severe or life-threatening adverse event rate with weekly doxorubicin and dacarbazine was 0.55. If it became evident that the rate of severe or life-threatening toxicity convincingly exceeded 0.55, the study would have been halted. Convincing evidence of exceeding 0.55 was based on Bayesian methods and continuous monitoring, where the stopping rule would have held enrollment if the posterior probability at any point exceeded 0.75 or higher.||0.1722|0.0008|
71933074|NCT03056001|143387113|OTHER|Estimation only|Median|1.3|||||TWO_SIDED|95.0|0.8|2.1|||||The Kaplan Meier method was used to estimate the median OS (in years) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.|||2.1|0.8|
71933075|NCT03056001|143387114|OTHER|Estimation only|Median|5.7|||||TWO_SIDED|95.0|4.1|8.3|||||The Kaplan Meier method was used to estimate the median PFS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.|||8.3|4.1|
71933076|NCT03056001|143387115|OTHER|Estimation only.|Rate|0.367|||||TWO_SIDED|95.0|0.199|0.561|||||Confidence interval estimated using the Clopper Pearson method.|||0.561|0.199|
71933077|NCT03056001|143387116|OTHER|Estimation only|Median|8.0|||||TWO_SIDED|95.0|2.8|34.6|||||The Kaplan Meier method was used to estimate the median DoR (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median duration of response.|||34.6|2.8|
71933078|NCT03567239|143387137|OTHER|"The PIADS is broken into 3 subgroups - Competence, Adaptability, and Self-Esteem. The minimum possible score is -3 and the maximum possible score is 3 for each subgroup - with positive 3 being the best. The 7-Point Likert scale was used in response to the question The device provided increased my ability to … in relation to the custom need they had. A response of 1 = Strongly disagree and 7 = strongly agree."|||||||||||||||||Median values: Overall = 2.42, Competence = 2.58, Adaptability = 2.33, Self-Esteem = 2.00, Likert = 7|||
71933079|NCT03567239|143387138|OTHER|||||||||||||||||The NASA Task Load Index ranges from 1 to 21 with the lower the score the better.|Median vales: Overall = 4.83, Mental demand = 11, Physical demand = 4, Temporal demand = 6, Performance = 3, Effort = 3, Frustration = 5.|||
71933080|NCT03567239|143387139|OTHER|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.||||||||||||||||The QUEST (Quebec User Evaluation of Satisfaction with Assistive Technology) evaluates a patient's satisfaction with various assistive technologies. It has two subgroups, Device and Service on a scale of 1-5 with 5 being the best score.|Median QUEST scores: Overall = 4.33, Device = 4.38, Services = 4.25.|||
71933081|NCT05003167|143387158|SUPERIORITY||F|8.48||||0.001|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.001
71933082|NCT05003167|143387160|SUPERIORITY||F|2.29||||0.113|TWO_SIDED|95.0|||||ANOVA|df = 2,44||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.113
71933083|NCT05003167|143387161|SUPERIORITY||F|3.17||||0.052|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.||||.052
71933084|NCT05003167|143387162|SUPERIORITY||F|0.07||||0.931|TWO_SIDED|95.0|||||ANOVA|||"A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05.~Results here are for percent of breaths at major boundaries."||||.931
71933085|NCT05003167|143387162|SUPERIORITY||F|0.23||||0.164|TWO_SIDED|95.0|||||ANOVA|||A mixed model ANOVA with session (pre-post-training) as a main effect and participant as a random factor was run via SAS 9.4. Alpha was set at .05. Results reflect percent of breaths at boundaries unrelated to syntax.||||0.164
71933086|NCT03958071|143387170|OTHER||Absolute standardized differences (ASD)|-0.1027||||0.281|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.2810
71933087|NCT03958071|143387170|OTHER||Absolute standardized differences (ASD)|-0.078||||0.1421|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1421
71933088|NCT03958071|143387170|OTHER||Absolute standardized differences (ASD)|0.0159||||0.0048|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0048
71933089|NCT03958071|143387172|OTHER||Absolute standardized differences (ASD)|0.0214||||0.7681|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7681
71933090|NCT03958071|143387172|OTHER||Absolute standardized differences (ASD)|0.371|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
71933091|NCT03958071|143387172|OTHER||Absolute standardized differences (ASD)|0.349|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
71933092|NCT03958071|143387173|OTHER||Absolute standardized differences (ASD)|-0.1257||||0.1659|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.1659
71933093|NCT03958071|143387173|OTHER||Absolute standardized differences (ASD)|0.1566||||0.0112|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.0112
71933094|NCT03958071|143387173|OTHER||Absolute standardized differences (ASD)|0.3019|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
71933095|NCT03958071|143387174|OTHER||Absolute standardized differences (ASD)|-0.0209||||0.326|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||0.3260
71933096|NCT03958071|143387174|OTHER||Absolute standardized differences (ASD)|-0.2694|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
71933097|NCT03958071|143387174|OTHER||Absolute standardized differences (ASD)|-0.2352|||<|0.0001|||||||t-test, 2 sided||ASD=(X1-X2)/sqrt((s1\^2+s2\^2)/2). Where X denotes sample means in each cohort, and s denotes sample variances.|||||<.0001
71933098|NCT03958071|143387175|OTHER||Absolute standardized differences (ASD)|0.09||||0.2042|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.2042
71933099|NCT03958071|143387175|OTHER||Absolute standardized differences (ASD)|0.21|||<|0.0001|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||<.0001
71933100|NCT03958071|143387175|OTHER||Absolute standardized differences (ASD)|0.11||||0.02|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.02
71933101|NCT03958071|143387176|OTHER||Absolute standardized differences (ASD)|0.0241||||0.7395|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.7395
71933102|NCT03958071|143387176|OTHER||Absolute standardized differences (ASD)|0.1644||||0.0017|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0017
71690887|NCT01677182|142897911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.792|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.792
71690888|NCT01677182|142897911|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.171|TWO_SIDED|97.5|-0.4|0.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.1|-0.4|0.171
71933103|NCT03958071|143387176|OTHER||Absolute standardized differences (ASD)|0.1403||||0.0034|||||||Chi-squared||ASD=(p1-p2)/(sqrt(p1\^(1-p1)+p2(1-p2))/2). Where p denotes proportion of a binary variable in each cohort.|||||0.0034
71933104|NCT00948025|143387231|OTHER|Mann-Whitney U test was used to derive p-values.||||||0.0433||||||"1. a priori threshold for statistical significance set at p\<0.05.~2. the p-value was not adjusted for multiple comparisons."|Wilcoxon (Mann-Whitney)|||"1. P-value comparing static 2-point discrimination per visit derived from mixed linear modeling of longitudinal data.~2. P-Value is based on Mann-Whitney U test."||||0.0433
71933105|NCT03182920|143387269|SUPERIORITY||Ratio of geometric least squares means|1.21|||||TWO_SIDED|90.0|0.962|1.52||||||||1.52|0.962|
71933106|NCT03182920|143387270|SUPERIORITY||Ratio of geometric least squares means|1.26|||||TWO_SIDED|90.0|1.03|1.55||||||||1.55|1.03|
71933107|NCT00782275|143387277|SUPERIORITY|||||||0.081|||||||exact binomial test|||The regimen was evaluated against an historical control with null and alternative 4-month PFS rates of 50% and 70%, respectively. With the final sample size of 40 eligible patients and using the same operating characteristics (alpha and beta 10%), the decision rule changes such that if 25 or more patients of 40 are alive and progression-free at 4 months then this regimen is considered promising.||||0.081
71933108|NCT00289731|143387291|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.66|||||TWO_SIDED|95.0|-5.34|1.48||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.48|-5.34|
71933109|NCT00289731|143387291|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.63|||||TWO_SIDED|95.0|-5.31|1.6||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.||1.60|-5.31|
71933110|NCT00289731|143387292|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%.|Difference in seroprotection rate|12.04|||||TWO_SIDED|95.0|4.97|19.35||||||Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.||19.35|4.97|
71933111|NCT00289731|143387292|NON_INFERIORITY|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%.|Difference in seroprotection rates|20.69|||||TWO_SIDED|95.0|12.92|28.62||||||Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.||28.62|12.92|
71933112|NCT04378010|143387321|OTHER||LS mean difference|1.88|STANDARD_ERROR_OF_MEAN|1.788||0.454|TWO_SIDED|95.0|-3.479|7.239|||Mixed model repeated measures|||||7.239|-3.479|0.454
71933113|NCT04378010|143387321|OTHER||LS mean difference|-0.439|STANDARD_ERROR_OF_MEAN|1.553||0.848|TWO_SIDED|95.0|-5.458|4.579|||Mixed model repeated measures|||||4.579|-5.458|0.848
71933114|NCT04378010|143387332|OTHER||LS mean difference|-11.718|STANDARD_ERROR_OF_MEAN|7.052||0.114|TWO_SIDED|95.0|-26.342|2.906|||ANCOVA|||||2.906|-26.342|0.114
71933115|NCT04378010|143387332|OTHER||LS mean difference|-11.261|STANDARD_ERROR_OF_MEAN|6.879||0.099|TWO_SIDED|95.0|-24.723|2.2|||ANCOVA|||||2.200|-24.723|0.099
71933116|NCT04378010|143387333|OTHER||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|0.331||0.003|TWO_SIDED|95.0|0.365|1.736|||ANCOVA|||||1.736|0.365|0.003
71933117|NCT04378010|143387333|OTHER||LS mean difference|0.591|STANDARD_ERROR_OF_MEAN|0.315||0.064|TWO_SIDED|95.0|-0.035|1.216|||ANCOVA|||||1.216|-0.035|0.064
71690889|NCT01677182|142897912|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.653|TWO_SIDED|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.3|-0.2|0.653
71933118|NCT04378010|143387337|OTHER||LS mean difference|12.986|STANDARD_ERROR_OF_MEAN|5.472||0.04|TWO_SIDED|95.0|0.608|25.363|||Mixed model repeated measures|||||25.363|0.608|0.040
71933119|NCT04378010|143387337|OTHER||LS mean difference|7.211|STANDARD_ERROR_OF_MEAN|5.724||0.242|TWO_SIDED|95.0|-4.997|19.418|||Mixed model repeated measures|||||19.418|-4.997|0.242
71933120|NCT00747747|143387368|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypothesis: no difference among groups.||||<0.05
71933121|NCT00747747|143387373|SUPERIORITY_OR_OTHER||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypotheis: no difference among the groups.||||<0.05
71933122|NCT02314520|143387388|SUPERIORITY|||||||0.271||||||0.05 is the threshold for significance for this primary outcome.|Fisher Exact|||||||0.271
71933123|NCT00467818|143387392|SUPERIORITY_OR_OTHER_LEGACY|||||||1|||||||t-test, 2 sided|||||||1.0
71933124|NCT00467818|143387393|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.1|TWO_SIDED||||||Mixed Models Analysis|||||||0.10
71933125|NCT00467818|143387395|SUPERIORITY||Mean Difference (Final Values)|0.5|||<|0.5|TWO_SIDED||||||Mixed Models Analysis|||||||<0.5
71933126|NCT00467818|143387396|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||Mixed Models Analysis|||||||0.5
71690890|NCT01677182|142897912|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.12||0.673|TWO_SIDED|97.5|-0.3|0.2||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||0.2|-0.3|0.673
71933127|NCT02143947|143387410|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
71933128|NCT02143947|143387411|SUPERIORITY_OR_OTHER||||||=|0.036|TWO_SIDED||||||Mixed Models Analysis|||||||= .036
71933129|NCT02143947|143387412|SUPERIORITY_OR_OTHER||||||>|0.1|TWO_SIDED||||||Mixed Models Analysis|||||||> .10
71933130|NCT02143947|143387413|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< .05
71933131|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-3.2||||0.008|TWO_SIDED|95.0|-5.6|-0.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.8|-5.6|0.008
71933132|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-5.3|||<|0.001|TWO_SIDED|95.0|-7.7|-2.9||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-2.9|-7.7|<0.001
71933133|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-6.2|||<|0.001|TWO_SIDED|95.0|-8.6|-3.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-3.8|-8.6|<0.001
71933134|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.92|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 1 (Placebo\<2.5 mg=5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 1. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71933135|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.87|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 2 (Placebo=2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 2. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71933136|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-3.4||||0.0021||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 3 (Placebo=2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 3. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||0.0021
71933137|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.28|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 4 (Placebo\<2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 4. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71933138|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-4.64|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 5 (Placebo=2.5 mg\<5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 5. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71933139|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.07|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 6 (Placebo\<2.5 mg=5.0 mg\<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 6. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71933140|NCT01244815|143387414|SUPERIORITY_OR_OTHER_LEGACY||t-statistic|-5.49|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 7 (Placebo\<2.5 mg\<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 7. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.||||<0.0001
71933141|NCT01244815|143387415|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.6|||<|0.001|TWO_SIDED|95.0|-0.9|-0.3||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.3|-0.9|<0.001
71690891|NCT01677182|142897913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.51||0.119|TWO_SIDED|97.5|-0.4|2.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.0|-0.4|0.119
71933142|NCT01244815|143387415|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-0.9|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-0.9|<0.001
71933143|NCT01244815|143387415|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.7|||<|0.001|TWO_SIDED|95.0|-1.0|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.4|-1.0|<0.001
71933144|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.0||||0.018|TWO_SIDED|95.0|1.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||7.6|1.2|0.018
71933145|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.4||||0.008|TWO_SIDED|95.0|1.4|8.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||8.6|1.4|0.008
71933146|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1||||0.129|TWO_SIDED|95.0|0.8|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)||5.6|0.8|0.129
71933147|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9||||0.003|TWO_SIDED|95.0|1.4|5.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.9|1.4|0.003
71933148|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8||||0.005|TWO_SIDED|95.0|1.4|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||5.6|1.4|0.005
71933149|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.6|||<|0.001|TWO_SIDED|95.0|1.8|7.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)||7.3|1.8|<0.001
71933150|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2||||0.018|TWO_SIDED|95.0|1.1|4.1||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||4.1|1.1|0.018
71933151|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
71933152|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|||<|0.001|TWO_SIDED|95.0|2.2|7.6|||Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)||7.6|2.2|<0.001
71933153|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9||||0.042|TWO_SIDED|95.0|1.0|3.4||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||3.4|1.0|0.042
71933154|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|||<|0.001|TWO_SIDED|95.0|1.7|5.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.8|1.7|<0.001
71933155|NCT01244815|143387416|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001||95.0|1.6|5.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of \>1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)||5.3|1.6|<0.001
71933156|NCT01244815|143387417|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25||||0.014|TWO_SIDED|95.0|-0.45|-0.05|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.05|-0.45|0.014
71933157|NCT01244815|143387417|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17||||0.107|TWO_SIDED|95.0|-0.37|0.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.04|-0.37|0.107
71933158|NCT01244815|143387417|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.039|TWO_SIDED|95.0|-0.42|-0.01|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.01|-0.42|0.039
71933159|NCT01244815|143387418|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.33||||0.006|TWO_SIDED|95.0|-0.56|-0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.10|-0.56|0.006
71933160|NCT01244815|143387418|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.35||||0.003|TWO_SIDED|95.0|-0.59|-0.12|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.12|-0.59|0.003
71933161|NCT01244815|143387418|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.44|||<|0.001|TWO_SIDED|95.0|-0.67|-0.21|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.21|-0.67|<0.001
71933162|NCT01244815|143387419|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.011|TWO_SIDED|95.0|-0.61|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.61|0.011
71933163|NCT01244815|143387419|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.63|||<|0.001|TWO_SIDED|95.0|-0.89|-0.36|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.36|-0.89|<0.001
71933164|NCT01244815|143387419|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.88|-0.35|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.35|-0.88|<0.001
71933165|NCT01244815|143387420|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.61|||<|0.001|TWO_SIDED|95.0|-0.9|-0.32|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.32|-0.90|<0.001
71933166|NCT01244815|143387420|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.75|||<|0.001|TWO_SIDED|95.0|-1.04|-0.46|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.46|-1.04|<0.001
71933167|NCT01244815|143387420|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.74|||<|0.001|TWO_SIDED|95.0|-1.03|-0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.45|-1.03|<0.001
71933168|NCT01244815|143387421|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.07||||0.536|TWO_SIDED|95.0|-0.28|0.15|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.15|-0.28|0.536
71933169|NCT01244815|143387421|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.03||||0.811|TWO_SIDED|95.0|-0.24|0.19|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.19|-0.24|0.811
71933170|NCT01244815|143387421|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.07||||0.556|TWO_SIDED|95.0|-0.15|0.28|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.28|-0.15|0.556
71933171|NCT01244815|143387422|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21||||0.053|TWO_SIDED|95.0|-0.42|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.00|-0.42|0.053
71933172|NCT01244815|143387422|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.18||||0.094|TWO_SIDED|95.0|-0.4|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.40|0.094
71933173|NCT01244815|143387422|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15||||0.178|TWO_SIDED|95.0|-0.36|0.07|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.07|-0.36|0.178
71933174|NCT01244815|143387423|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.08||||0.506|TWO_SIDED|95.0|-0.33|0.16|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.16|-0.33|0.506
71933175|NCT01244815|143387423|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19||||0.131|TWO_SIDED|95.0|-0.43|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.43|0.131
71933176|NCT01244815|143387423|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16||||0.211|TWO_SIDED|95.0|-0.4|0.09|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.09|-0.40|0.211
71933177|NCT01244815|143387424|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23||||0.079|TWO_SIDED|95.0|-0.49|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.03|-0.49|0.079
71933178|NCT01244815|143387424|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.34||||0.01|TWO_SIDED|95.0|-0.6|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.08|-0.60|0.010
71933179|NCT01244815|143387424|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.2||||0.139|TWO_SIDED|95.0|-0.46|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.06|-0.46|0.139
71933180|NCT01244815|143387425|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.61||||0.004|TWO_SIDED|95.0|-4.38|-0.83|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.83|-4.38|0.004
71933181|NCT01244815|143387425|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.17||||0.017|TWO_SIDED|95.0|-3.95|-0.39|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.39|-3.95|0.017
71933182|NCT01244815|143387425|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.16||||0.017|TWO_SIDED|95.0|-3.93|-0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.38|-3.93|0.017
71690892|NCT01677182|142897913|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.791|TWO_SIDED|97.5|-1.3|1.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.0|-1.3|0.791
71933183|NCT01244815|143387426|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.79||||0.395|TWO_SIDED|95.0|-2.62|1.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||1.04|-2.62|0.395
71933184|NCT01244815|143387426|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.44||||0.009|TWO_SIDED|95.0|-4.26|-0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.63|-4.26|0.009
71933185|NCT01244815|143387426|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.121|TWO_SIDED|95.0|-3.27|0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.38|-3.27|0.121
71933186|NCT01244815|143387427|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.44||||0.135|TWO_SIDED|95.0|-3.33|0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.45|-3.33|0.135
71933187|NCT01244815|143387427|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-2.19||||0.023|TWO_SIDED|95.0|-4.08|-0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||-0.30|-4.08|0.023
71933188|NCT01244815|143387427|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-1.28||||0.189|TWO_SIDED|95.0|-3.2|0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo - 98, asenapine 2.5 mg - 101, asenapine 5.0 mg - 98, asenapine 10.0 mg - 98)||0.63|-3.20|0.189
71933189|NCT01244815|143387428|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|4.29||||0.002|TWO_SIDED|95.0|1.56|7.02|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.02|1.56|0.002
71933190|NCT01244815|143387428|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|6.95|||<|0.001|TWO_SIDED|95.0|4.22|9.68|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||9.68|4.22|<0.001
71933191|NCT01244815|143387428|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|5.11|||<|0.001|TWO_SIDED|95.0|2.31|7.91|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||7.91|2.31|<0.001
71933192|NCT01244815|143387429|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.24||||0.05|TWO_SIDED|95.0|0.0|4.48|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||4.48|-0.00|0.050
71933193|NCT01244815|143387429|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|1.35||||0.239|TWO_SIDED|95.0|-0.9|3.59|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||3.59|-0.90|0.239
71933194|NCT01244815|143387429|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|2.78||||0.018|TWO_SIDED|95.0|0.48|5.08|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||5.08|0.48|0.018
71933195|NCT01244815|143387430|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.39||||0.001|TWO_SIDED|95.0|0.15|0.62|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.62|0.15|0.001
71933196|NCT01244815|143387430|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.18||||0.135|TWO_SIDED|95.0|-0.06|0.41|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.41|-0.06|0.135
71933197|NCT01244815|143387430|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|0.25||||0.044|TWO_SIDED|95.0|0.01|0.49|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo|||0.49|0.01|0.044
71933198|NCT02444182|143387459|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|STANDARD_DEVIATION|0.21||0.015|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in Gingival index between probiotics and control groups||||0.015
71933199|NCT02444182|143387460|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.09||0.909|TWO_SIDED||||||paired t-test|||Null hypothesis was no difference in plaque index between probiotics and control groups||||0.909
71933200|NCT00423488|143387482|SUPERIORITY_OR_OTHER_LEGACY||least-squares means|-11.5||||0.005||95.0|-19.4|-3.5|||ANOVA|The analysis of variance (ANOVA) model included term of treatment effect. If more than one basal value was available, the latest was used.||||-3.5|-19.4|0.005
71933201|NCT01749033|143387496|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76|||||||Chi-squared|||We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.76
71933202|NCT01749033|143387498|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02||||0.05|TWO_SIDED||||||Chi-squared||The reported p value was calculated.|We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.||||.05
71933203|NCT00363129|143387521|SUPERIORITY_OR_OTHER|||||||0.43|||||||Chi-squared|||||||0.43
71933204|NCT00363129|143387522|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||0.49
71933205|NCT00363129|143387523|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71933206|NCT00725725|143387549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5299||||0.3934|TWO_SIDED|95.0|-2.0781|5.138|||Mixed Models Analysis|||||5.1380|-2.0781|0.3934
71933207|NCT00725725|143387549|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2667||||0.3515|TWO_SIDED|95.0|-1.4665|4.0|||Mixed Models Analysis|||||4.0000|-1.4665|0.3515
71933208|NCT00725725|143387550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8246||||0.3597|TWO_SIDED|95.0|-5.8307|2.1815|||Mixed Models Analysis|||||2.1815|-5.8307|0.3597
71933209|NCT00725725|143387550|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4414||||0.777|TWO_SIDED|95.0|-3.5952|2.7124|||Mixed Models Analysis|||||2.7124|-3.5952|0.7770
71933210|NCT00725725|143387551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.3356||||0.2683|TWO_SIDED|95.0|-1.8933|6.5644|||Mixed Models Analysis|||||6.5644|-1.8933|0.2683
71933211|NCT00725725|143387551|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1317||||0.0844|TWO_SIDED|95.0|-0.4518|6.7152|||Mixed Models Analysis|||||6.7152|-0.4518|0.0844
71933212|NCT00725725|143387555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3456||||0.8894|TWO_SIDED|95.0|-4.6211|5.3124|||Mixed Models Analysis|||||5.3124|-4.6211|0.8894
71933213|NCT00725725|143387555|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0417||||0.3765|TWO_SIDED|95.0|-2.5526|6.636|||Mixed Models Analysis|||||6.6360|-2.5526|0.3765
71933214|NCT00725725|143387556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2502||||0.8073|TWO_SIDED|95.0|-11.4963|8.9958|||Mixed Models Analysis|||||8.9958|-11.4963|0.8073
71933215|NCT00725725|143387556|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0291||||0.661|TWO_SIDED|95.0|-7.2132|11.2714|||Mixed Models Analysis|||||11.2714|-7.2132|0.6610
71933216|NCT00725725|143387557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7296||||0.7895|TWO_SIDED|95.0|-4.7291|6.1883|||Mixed Models Analysis|||||6.1883|-4.7291|0.7895
71933217|NCT00725725|143387557|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.526||||0.5488|TWO_SIDED|95.0|-3.5495|6.6015|||Mixed Models Analysis|||||6.6015|-3.5495|0.5488
71690893|NCT01677182|142897914|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.422|TWO_SIDED|97.5|-1.0|2.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.1|-1.0|0.422
71933218|NCT00725725|143387558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2766||||0.6516|TWO_SIDED|95.0|-6.9269|4.3738|||Mixed Models Analysis|||||4.3738|-6.9269|0.6516
71933219|NCT00725725|143387558|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1867||||0.0256|TWO_SIDED|95.0|-11.5864|-0.7869|||Mixed Models Analysis|||||-0.7869|-11.5864|0.0256
71690894|NCT01677182|142897914|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.7||0.655|TWO_SIDED|97.5|-1.3|1.9||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||1.9|-1.3|0.655
71690895|NCT01677182|142897915|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|1.64||0.696|TWO_SIDED|97.5|-4.5|2.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||2.8|-4.5|0.696
71933220|NCT03125915|143387569|SUPERIORITY||Beta|-3.62||||0.03|TWO_SIDED|95.0|-6.78|-0.46||A multi-level latent growth curve (LGC) with a intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-leve latent growth curve||For 1-Month Follow-Up, substance use module (SUM) among those who did not view CT Video|||-0.46|-6.78|.03
71690896|NCT01677182|142897915|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|1.63||0.472|TWO_SIDED|97.5|-3.6|3.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures|||||3.8|-3.6|0.472
71933221|NCT03125915|143387569|SUPERIORITY||Beta|-1.67||||0.18|TWO_SIDED|95.0|-4.1|0.76||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did view the CT video.|||0.76|-4.10|.18
71933222|NCT03125915|143387569|SUPERIORITY||Beta|-0.35||||0.75|TWO_SIDED|95.0|-2.5|1.8||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow up, effect of CT video among those who completed the SUM.|||1.80|-2.50|0.75
71933223|NCT03125915|143387569|SUPERIORITY||Beta|-2.3||||0.14|TWO_SIDED|95.0|-5.37|0.77||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-Month follow up, effect of CT video among those who did not complete SUM.|||0.77|-5.37|0.14
71933224|NCT03125915|143387569|SUPERIORITY||Beta|-2.79||||0.013|TWO_SIDED|95.0|-5.0|-0.58||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who viewed the CT video.|||-0.58|-5.00|0.013
71933225|NCT03125915|143387569|SUPERIORITY||Beta|-2.09||||0.1|TWO_SIDED|95.0|-4.56|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who did not view CT video|||0.38|-4.56|0.10
71933226|NCT03125915|143387569|SUPERIORITY||Beta|0.4||||0.78|TWO_SIDED|95.0|-2.35|3.16||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT Video among those who completed the SUM|A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.||3.16|-2.35|0.78
71933227|NCT03125915|143387569|SUPERIORITY||Beta|-0.3||||0.75|TWO_SIDED|95.0|-2.12|1.53||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||1.53|-2.12|0.75
71933228|NCT03125915|143387569|SUPERIORITY||Beta|-3.93||||0.014|TWO_SIDED|95.0|-7.06|-0.81||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed the CT video.|||-0.81|-7.06|0.014
71933229|NCT03125915|143387569|SUPERIORITY||Beta|-0.57||||0.67|TWO_SIDED|95.0|-3.16|2.03||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of SUM among those who did not view CT video.|||2.03|-3.16|0.67
71933230|NCT03125915|143387569|SUPERIORITY||Beta|-0.24||||0.83|TWO_SIDED|95.0|-2.39|1.91||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of CT video among those who completed the SUM.|||1.91|-2.39|0.83
71933231|NCT03125915|143387569|SUPERIORITY||Beta|3.13||||0.05|TWO_SIDED|95.0|-0.004|6.25||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of CT video among those who did not complete SUM.|||6.25|-0.004|0.05
71933232|NCT03125915|143387570|SUPERIORITY||Beta|0.05||||0.9|TWO_SIDED|95.0|-2.3|2.41||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent intercept factor among those who did not view CT videos|||2.41|-2.30|0.90
71933233|NCT03125915|143387570|SUPERIORITY||Beta|0.26||||0.78|TWO_SIDED|95.0|-2.23|2.75||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT video on the latent intercept factor among those who did not view SUM.|||2.75|-2.23|0.78
71690897|NCT01677182|142897916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.998||||0.994|TWO_SIDED|95.0|0.651|1.53||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.530|0.651|0.994
71690898|NCT01677182|142897916|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.886||||0.575|TWO_SIDED|95.0|0.58|1.352||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.352|0.580|0.575
71690899|NCT01677182|142897917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.978||||0.927|TWO_SIDED|95.0|0.606|1.577||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.577|0.606|0.927
71933234|NCT03125915|143387570|SUPERIORITY||Beta|-1.18||||0.53|TWO_SIDED|95.0|-4.86|2.51||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT video on the latent intercept.|||2.51|-4.86|0.53
71933235|NCT03125915|143387570|SUPERIORITY||Beta|1.83||||0.14|TWO_SIDED|95.0|-0.62|4.29||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent slope factor among those who did not view CT Videos.|||4.29|-0.62|0.14
71933236|NCT03125915|143387570|SUPERIORITY||Beta|0.35||||0.76|TWO_SIDED|95.0|-2.02|2.72||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT Video on latent slope factor among those who did not complete the SUM.|||2.72|-2.02|0.76
71933237|NCT03125915|143387570|SUPERIORITY||Beta|-1.28||||0.45|TWO_SIDED|95.0|-4.62|2.06||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor.|||2.06|-4.62|0.45
71933238|NCT03125915|143387571|SUPERIORITY||Beta|-0.75||||0.02|TWO_SIDED|95.0|-1.39|-0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who viewed CT videos.|||-0.11|-1.39|0.02
71933239|NCT03125915|143387571|SUPERIORITY||Beta|-0.49||||0.1|TWO_SIDED|95.0|-1.07|0.09||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view CT videos.|||0.09|-1.07|0.10
71933240|NCT03125915|143387571|SUPERIORITY||Beta|-0.15||||0.63|TWO_SIDED|95.0|-0.77|0.47||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who completed SUM.|||0.47|-0.77|0.63
71933241|NCT03125915|143387571|SUPERIORITY||Beta|-0.41||||0.19|TWO_SIDED|95.0|-1.01|0.2||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who did not complete SUM.|||0.20|-1.01|0.19
71933242|NCT03125915|143387571|SUPERIORITY||Beta|-0.64||||0.01|TWO_SIDED|95.0|-1.13|-0.15||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of SUM among those who completed the CT video.|||-0.15|-1.13|0.01
71933243|NCT03125915|143387571|SUPERIORITY||Beta|-0.49||||0.12|TWO_SIDED|95.0|-1.11|0.12||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of SUM among those who did not complete CT video.|||0.12|-1.11|0.12
71933244|NCT03125915|143387571|SUPERIORITY||Beta|-0.34||||0.23|TWO_SIDED|95.0|-0.89|0.21||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of CT video among those who completed SUM.|||0.21|-0.89|0.23
71933245|NCT03125915|143387571|SUPERIORITY||Beta|-0.19||||0.51|TWO_SIDED|95.0|-0.76|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.|||0.38|-0.76|0.51
71933246|NCT03125915|143387571|SUPERIORITY||Beta|-0.79||||0.003|TWO_SIDED|95.0|-1.32|-0.27||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed CT videos.|||-0.27|-1.32|0.003
71933247|NCT03125915|143387571|SUPERIORITY||Beta|-0.25||||0.49|TWO_SIDED|95.0|-0.96|0.46||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of SUM among those who did not view the CT video.|||0.46|-0.96|0.49
71933248|NCT03125915|143387571|SUPERIORITY||Beta|-0.53||||0.1|TWO_SIDED|95.0|-1.16|0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who completed SUM.|||0.11|-1.16|0.10
71933249|NCT03125915|143387571|SUPERIORITY||Beta|-0.02||||0.96|TWO_SIDED|95.0|-0.6|0.64||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who did not complete SUM.|||0.64|-0.60|0.96
71933250|NCT02517099|143387574|SUPERIORITY||Median Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|0.384||0.05|TWO_SIDED|95.0|1.591|8.8|||Wilcoxon (Mann-Whitney)|||||8.80|1.591|0.05
71933251|NCT01123980|143387578|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D \> 0.4% against HA: D =\< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%|Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.07|<|0.001||95.0|-0.25|0.02||The p-values correspond to one-sided hypotheses of either non-inferiority or superiority, statistical significance level is 2.5%.|ANCOVA|The estimates are from a normal linear regression model with treatment, country and previous OADs as factors and baseline HbA1c as a covariate||H0: The mean treatment difference (BIAsp 30 minus insulin glargine) \> 0.4%. HA: The mean treatment difference (BIAsp 30 minus insulin glargine) =\< 0.4%. Sample size was calculated to achieve a power of at least 90%, assuming an equal change in HbA1c and a common standard deviation of 1.25%||0.02|-0.25|< 0.001
71933252|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03|||<|0.001||95.0|-0.24|0.19||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.19|-0.24|<0.001
71933253|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|||<|0.001||95.0|-0.45|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.45|<0.001
71933254|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001||95.0|-0.31|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.58|-0.31|<0.001
71933255|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|||<|0.001||95.0|-0.26|0.82||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.82|-0.26|<0.001
71933256|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|||<|0.001||95.0|0.22|1.06||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||1.06|0.22|<0.001
71933257|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51|||<|0.001||95.0|-2.03|-1.0||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-1.00|-2.03|<0.001
71933258|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|||<|0.001||95.0|-1.73|-0.78||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Bedtime|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.78|-1.73|<0.001
71933259|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|||<|0.001||95.0|-0.81|-0.13||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||02 - 04 a.m.|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||-0.13|-0.81|<0.001
71933260|NCT01123980|143387579|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|||<|0.001||95.0|-0.06|0.4||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast the following day|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.||0.40|-0.06|<0.001
71933261|NCT01123980|143387580|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8583||95.0|0.64|1.46|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c less than 7% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.46|0.64|0.8583
71933262|NCT01123980|143387581|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.8013||95.0|0.64|1.79|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c below or equal to 6.5% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.||1.79|0.64|0.8013
71933263|NCT02094937|143387601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.31|2.49||||||||2.49|0.31|
71933264|NCT02094937|143387601|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.28|2.19||||||||2.19|0.28|
71933265|NCT02094937|143387602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93|||||TWO_SIDED|95.0|0.9|4.12||||||||4.12|0.90|
71933266|NCT02094937|143387602|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.45|||||TWO_SIDED|95.0|0.66|3.2||||||||3.20|0.66|
71933267|NCT01133392|143387609|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.99|||||TWO_SIDED|90.0|0.948|1.034||||||||1.034|0.948|
71933268|NCT01133392|143387610|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.933|||||TWO_SIDED|90.0|0.897|0.972||||||||0.972|0.897|
71933269|NCT01133392|143387611|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.005|||||TWO_SIDED|90.0|0.958|1.054||||||||1.054|0.958|
71933270|NCT01133392|143387612|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.1|||||TWO_SIDED|90.0|-0.4|0.5||||||||0.500|-0.400|
71933271|NCT01133392|143387613|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|1.014|||||TWO_SIDED|90.0|0.961|1.07||||||||1.070|0.961|
71933272|NCT02842086|143387614|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.468|||||TWO_SIDED|95.003|0.191|1.149||||||Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.149|0.191|
71933273|NCT02842086|143387615|SUPERIORITY||Difference in least squares mean (LSM)|1.142|||<|0.0001|TWO_SIDED|95.0|0.628|1.655|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.||1.655|0.628|<0.0001
71933274|NCT02842086|143387616|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.913|2.22|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.220|0.913|<0.0001
71933275|NCT02842086|143387617|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71933276|NCT02842086|143387618|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71933277|NCT02842086|143387619|SUPERIORITY|||||||0.0048||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.0048
71933278|NCT02842086|143387620|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
71933279|NCT02842086|143387621|NON_INFERIORITY|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.536|||||TWO_SIDED|95.003|0.227|1.264||||||Noninferiority was assessed using a 95.003% CI constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.||1.264|0.227|
71933280|NCT02842086|143387622|SUPERIORITY||Difference in LSM|1.567|||<|0.0001|TWO_SIDED|95.0|0.896|2.237|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||2.237|0.896|<0.0001
71933281|NCT02842086|143387623|SUPERIORITY||Difference in LSM|2.253|||<|0.0001|TWO_SIDED|95.0|1.437|3.069|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.||3.069|1.437|<0.0001
71933282|NCT02842086|143387624|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71933283|NCT02842086|143387625|SUPERIORITY||||||<|0.0001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test|||||||<0.0001
71933284|NCT02842086|143387626|SUPERIORITY|||||||0.2163||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus \> 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance|||||||0.2163
71933285|NCT02842086|143387627|SUPERIORITY||Difference in LSM|-0.02|||<|0.0001|TWO_SIDED|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.||-0.01|-0.02|<0.0001
71933286|NCT03751124|143387630|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|63.36|||<|0.0001|TWO_SIDED|95.0|52.85|73.86||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% confidence interval (CI) of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|The primary efficacy analysis was the comparison of the relugolix plus E2/NETA group with the placebo group with respect to responder rate.||73.86|52.85|<0.0001
71933287|NCT03751124|143387631|OTHER|Stratified log-rank test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Hazard Ratio (HR)|0.13|||<|0.0001|TWO_SIDED|95.0|0.08|0.2||P-value for comparison of relugolix plus E2/NETA to placebo was based on the stratified log-rank test.|Log Rank||Hazard ratio (95% CI) of relugolix plus E2/NETA to placebo was based on a proportional hazard model stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|||0.20|0.08|<0.0001
71933288|NCT03751124|143387632|OTHER|Chi-square test was used for the comparison between relugolix plus E2/NETA group and placebo group.|Treatment difference|58.04|||<|0.0001|TWO_SIDED|95.0|46.97|69.11||P-value was based on the stratified test statistics via log-log transformation of the difference in survival curve at a fixed time point stratified by pivotal study baseline MBL volume and duration of prior exposure to relugolix.|Log-Log transformation|Log-Log transformation of survival curve based on stratified Kaplan-Meier analysis|The 95% CI of treatment difference was calculated via linear transformation of the difference in survival function with pooled variance.|||69.11|46.97|<0.0001
71933289|NCT03751124|143387633|SUPERIORITY||Treatment difference|44.12|||<|0.0001|TWO_SIDED|95.0|33.13|55.11||P-value for difference between relugolix plus E2/NETA and placebo is based on Cochran-Mantel-Haenszel test stratified by pivotal study baseline MBL volume (\<225 mL or ≥225 mL) and duration of prior exposure to relugolix (28 weeks or 52 weeks).|Cochran-Mantel-Haenszel||Treatment difference is relugolix plus E2/NETA minus placebo. 95% CI for difference is based on the normal approximation.|||55.11|33.13|<0.0001
71933290|NCT02450760|143387688|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71933291|NCT02450760|143387689|SUPERIORITY|||||||0.95|||||||t-test, 2 sided|||||||0.95
71933292|NCT02450760|143387693|SUPERIORITY|||||||0.15|||||||Chi-squared|||||||0.15
71933293|NCT02450760|143387694|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71933294|NCT02450760|143387695|SUPERIORITY|||||||0.26|||||||Chi-squared|||||||0.26
71933295|NCT03053622|143387696|OTHER||Ratio of Geometric Least Squares Means|0.996|||||TWO_SIDED|90.0|0.807|1.23||||||||1.23|0.807|
71933296|NCT03053622|143387696|OTHER||Ratio of Geometric Least Squares Means|0.729|||||TWO_SIDED|90.0|0.591|0.898||||||||0.898|0.591|
71933297|NCT03053622|143387696|OTHER||Ratio of Geometric Least Squares Means|0.422|||||TWO_SIDED|90.0|0.343|0.518||||||||0.518|0.343|
71933298|NCT03053622|143387696|OTHER||Ratio of Geometric Least Squares Means|0.307|||||TWO_SIDED|90.0|0.249|0.379||||||||0.379|0.249|
71933299|NCT03053622|143387697|OTHER||Ratio of Geometric Least Squares Means|0.986|||||TWO_SIDED|90.0|0.81|1.2||||||||1.20|0.810|
71933300|NCT03053622|143387697|OTHER||Ratio of Geometric Least Squares Means|0.753|||||TWO_SIDED|90.0|0.619|0.916||||||||0.916|0.619|
71933301|NCT03053622|143387698|OTHER||Median Difference (Final Values)|0.28|||||TWO_SIDED|90.0|-0.1|48.4||||||||48.40|-0.10|
71933302|NCT03053622|143387698|OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|-0.25|23.97|||||"In this outcome, the median difference is not calculated by subtracting two observations, it is derived by Hodges-Lehmann approach to estimating location shift. This method will give the value of 0.25."|||23.97|-0.25|
71933303|NCT00581386|143387701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125||||0.013||95.0|1.27|7.67|||Regression, Logistic|Logistic regression Number of obs = 217, LR chi2(2)=10.89, Prob\>chi2=0.0043,Log likelihood = -112.87788, Pseudo R2=0.0460|this is a simple odds ratio|||7.67|1.27|0.013
71933304|NCT00581386|143387701|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81||||0.003||95.0|1.57|9.29|||Odds ratio|||||9.29|1.57|0.003
71933305|NCT00581386|143387702|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.006||||0.006||95.0|||||t-test, 2 sided|||||||0.006
71933306|NCT00581386|143387703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.088||||0.003||95.0|1.728|14.99|||Regression, Logistic|||||14.99|1.728|0.003
71933307|NCT00581386|143387703|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.22||||0.0004||95.0|2.419|21.527|||Regression, Logistic|||||21.527|2.419|0.0004
71933308|NCT01355523|143387705|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Chi-squared|||||||0.008
71933309|NCT01355523|143387705|SUPERIORITY_OR_OTHER||Number need to treat|2.95|||||TWO_SIDED|95.0|1.703|11.024||||||||11.024|1.703|
71933310|NCT01355523|143387705|SUPERIORITY_OR_OTHER||Relative Risk|0.25|||||TWO_SIDED|95.0|0.076|0.797||||||||0.797|0.076|
71933311|NCT01355523|143387706|SUPERIORITY_OR_OTHER|||||||0.125||95.0|||||Fisher Exact|||||||0.125
71933312|NCT01355523|143387707|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||Fisher Exact|||||||0.460
71933313|NCT01355523|143387708|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Chi-squared|||||||0.002
71933314|NCT01355523|143387709|SUPERIORITY_OR_OTHER|||||||0.264||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.264
71933315|NCT01355523|143387710|SUPERIORITY_OR_OTHER|||||||0.351||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.351
71933316|NCT01355523|143387711|SUPERIORITY_OR_OTHER|||||||0.446||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.446
71933317|NCT01355523|143387712|SUPERIORITY_OR_OTHER|||||||0.122||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.122
71933318|NCT01355523|143387713|SUPERIORITY_OR_OTHER|||||||0.907||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.907
71933319|NCT01355523|143387714|SUPERIORITY_OR_OTHER|||||||0.555||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.555
71933320|NCT01355523|143387715|SUPERIORITY_OR_OTHER|||||||0.93||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.930
71933321|NCT01355523|143387716|SUPERIORITY_OR_OTHER|||||||0.386||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.386
71933322|NCT01355523|143387717|SUPERIORITY_OR_OTHER|||||||0.241||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.241
71933323|NCT01355523|143387718|SUPERIORITY_OR_OTHER|||||||0.339||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.339
71933324|NCT01355523|143387719|SUPERIORITY_OR_OTHER|||||||0.578||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.578
71933325|NCT01355523|143387720|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Wilcoxon (Mann-Whitney)|||||||1.000
71933326|NCT01406873|143387755|SUPERIORITY||||||<|0.01|||||||ANCOVA|||||||<0.01
71933327|NCT00207714|143387759|SUPERIORITY_OR_OTHER|||||||0.01||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.||||0.010
71933328|NCT00207714|143387759|SUPERIORITY_OR_OTHER|||||||0.056|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.056
71933329|NCT00207714|143387759|SUPERIORITY_OR_OTHER|||||||0.281|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.281
71933330|NCT00207714|143387759|SUPERIORITY_OR_OTHER|||||||0.119|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||0.119
71933331|NCT00207714|143387759|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.||||<0.001
71933332|NCT00207714|143387760|SUPERIORITY_OR_OTHER|||||||0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.||||0.001
71933333|NCT00207714|143387760|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks||||0.006
71933334|NCT00207714|143387760|SUPERIORITY_OR_OTHER|||||||0.095|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks||||0.095
71690900|NCT01677182|142897917|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.865||||0.553|TWO_SIDED|95.0|0.536|1.397||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic|||||1.397|0.536|0.553
71933335|NCT00207714|143387760|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA on van der Waerden normal scores.|ANOVA on van der Waerden normal scores||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks||||0.010
71690901|NCT00995722|142897919|NON_INFERIORITY_OR_EQUIVALENCE|N=80, (40 per group), 80% power to detect a group difference of 30%-35% and 5% significance level.|Mean Difference (Final Values)|-2.2||||0.37|TWO_SIDED|95.0|-7.2|2.8|||ANCOVA|ANCOVA used to compare mean values adjusting for the baseline value|QMG Score ranges from 0-15, where 0 is normal and a reduction in score represents imrovement.|Mean Ocular QMG Changes from Baseline to Week 16 . 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||2.8|-7.20|0.37
71933336|NCT00207714|143387760|SUPERIORITY_OR_OTHER||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks||||<0.001
71933337|NCT02580318|143387780|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)|t-test, 2 sided|||this p value is calculated for poor effort||||<0.0001
71933338|NCT02580318|143387780|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)|t-test, 2 sided|||p value calculated for hyperventilation (immediate)||||<0.0001
71933339|NCT02580318|143387780|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 5 minutes)||||<0.0001
71933340|NCT02580318|143387780|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 10 minutes)||||<0.0001
71933341|NCT02580318|143387780|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)|t-test, 2 sided|||p value calculated for drinking water (immediate)||||<0.0001
71933342|NCT02580318|143387780|OTHER||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)|t-test, 2 sided|||p value calculated for drinking water (5 minutes)||||<0.0001
71933343|NCT02082912|143387844|SUPERIORITY||F statistic|0.216||||0.651|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.651
71933344|NCT02082912|143387845|SUPERIORITY||F statistic|0.633||||0.447|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.447
71933345|NCT02082912|143387846|SUPERIORITY||F statistic|0.557||||0.471|TWO_SIDED||||||ANOVA|||Values represent the time x treatment group interaction.||||0.471
71933346|NCT04126733|143387880|EQUIVALENCE|H0: ORR ≤ 5% versus H1: ORR \>5% The hypothesis was tested by a one-sided exact binomial test, assuming a background response rate for the combination to be at most 5%.|Rate|7.1||||0.2721||95.0|2.4|15.9||The target response rate for the combination treatment was 17%. Using a one-sided exact binomial test at a type-I error of at most 2.5% at least 8 responders out of the 70 patients were needed to achieve significance.|Exact Binomial Test|||||15.9|2.4|0.2721
71933347|NCT02629133|143387894|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.560
71933348|NCT02629133|143387894|SUPERIORITY|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months||||0.760
71933349|NCT02629133|143387895|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71933350|NCT02629133|143387895|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.||||0.029
71933351|NCT02629133|143387896|SUPERIORITY||Mean Difference (Final Values)|4.5||||0.325|TWO_SIDED|95.0|-4.5|13.5||We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.|Mixed Models Analysis|||||13.5|-4.5|0.325
71933352|NCT02629133|143387897|SUPERIORITY||Mean Difference (Final Values)|1.19||||0.192|TWO_SIDED|95.0|-0.61|2.98||We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||Higher scores represent more cyber-stalking over follow-up.|||2.98|-0.61|0.192
71933353|NCT02629133|143387898|SUPERIORITY||Mean Difference (Final Values)|-1.43||||0.119|TWO_SIDED|95.0|-3.24|0.38||We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.|Mixed Models Analysis||Higher is better (reflecting more safety behaviors used).|||0.38|-3.24|0.119
71933354|NCT02354976|143387911|OTHER||Geometric mean ratio for difference|0.92||||0.407|TWO_SIDED|95.0|0.76|1.12|||Mixed Models Analysis|||||1.12|0.76|0.407
71933355|NCT02354976|143387912|OTHER||Geometric mean ratio for difference|0.84||||0.077|TWO_SIDED|95.0|0.7|1.02|||Mixed Models Analysis|||||1.02|0.70|0.077
71690902|NCT00995722|142897920|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment|Mean Difference (Net)|6.56||||0.13|TWO_SIDED|95.0|-2.59|15.71|||ANCOVA||Scores ranges fro 0-100 , where 100 is normal and an increase in score represents an improvement|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||15.71|-2.59|0.13
71690903|NCT00995722|142897921|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment|Mean Difference (Final Values)|-3.81||||0.15|TWO_SIDED|95.0|-9.37|1.75|||ANCOVA||Ranges from 0-60, where 0 is Normal and a reduction in score represents improvement.|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||1.75|-9.37|0.15
71690904|NCT00995722|142897922|NON_INFERIORITY_OR_EQUIVALENCE|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16.|Mean Difference (Final Values)|16.98||||0.16|TWO_SIDED|95.0|-9.22|43.17|||ANCOVA||Ranges 0-100, where 100 is normal and an increase in score represents an improvement.|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.||43.17|-9.22|0.16
71690905|NCT00762762|142897927|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71690906|NCT00762762|142897928|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71690907|NCT00762762|142897929|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71690908|NCT00762762|142897930|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71690909|NCT00762762|142897931|OTHER|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.||||0.05
71933356|NCT00986154|143387913|NON_INFERIORITY_OR_EQUIVALENCE|The study was designed to accumulate approximately 220 Overall primary efficacy events in the mITT (modified Intent to Treat) Analysis Set. Assuming equal efficacy (Hazard Ratio = 1.00), a total of 220 events gave a power of 85% to demonstrate that (LMW) heparin/edoxaban was non-inferior to the comparator, considering a relative non-inferiority margin of 1.5 (two sided α=0.05).|Hazard Ratio (HR)|0.89|||<|0.0001|TWO_SIDED|95.0|0.703|1.128|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|(LMW) heparin/edoxaban will be non-inferior to (LMW) heparin/warfarin in preventing recurrence of acute, symptomatic VTE following initial index event. (LMW) Heparin/edoxaban was considered non-inferior to the standard therapy (\[LMW\] heparin/warfarin) if the upper limit of the two-sided 95% confidence interval (CI) for the Hazard Ratio (\[LMW\] heparin/edoxaban to standard therapy) was less than 1.5. Events included in Overall study period if occurred on or after randomization date up to Day 365.||1.128|.703|<0.0001
71690910|NCT00762762|142897932|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71690911|NCT00762762|142897933|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05|TWO_SIDED|95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71690912|NCT00762762|142897934|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71690913|NCT00762762|142897935|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71690914|NCT00762762|142897936|SUPERIORITY_OR_OTHER_LEGACY|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71690915|NCT02861664|142897986|OTHER||Least square (LS) mean difference|-0.6|||<|0.0001||95.0|-0.8|-0.4||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.4|-0.8|<.0001
71690916|NCT02603211|142898017|OTHER||||||||||||||||||"We will obtain 20 tactile image data sets from the breast tumor patients. The tactile images will be converted to size and deformation index. Then these two parameters will be converted to the risk score. This is a small number of patients for statistically significance study. Therefore, we plan to use the Leave-One-Out-Cross-Validation (LOOCV) technique to validate the human test results to determine the performance of the device.~We obtain the Risk Score. Risk Score is a unit less numerical value, which can be used as a scale to classify the tumor as malignant and benign. Based on the calculated size of the tumor and measured deformation index, the breast tumors are classified as benign and malignant using scoring method. The risk score will range from 0 to 5, where 0 represents the benign and 5 represents the malignant tumor.~Comparing the Risk Score and the Pathology reports we obtain sensitivity, specificity and accuracy of the system."|||
71690917|NCT03397121|142898032|SUPERIORITY||Mean Difference (Final Values)|-49.52|||<|0.0001|TWO_SIDED|95.0|-55.04|-43.99||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-43.99|-55.04|<.0001
71690918|NCT03397121|142898033|SUPERIORITY||Mean Difference (Final Values)|-44.3|||<|0.0001|TWO_SIDED|95.0|-48.48|-40.12||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-40.12|-48.48|<0.0001
71690919|NCT03397121|142898034|SUPERIORITY||Mean Difference (Final Values)|-68.89|||<|0.0001|TWO_SIDED|95.0|-77.11|-60.67||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-60.67|-77.11|<0.0001
71690920|NCT03397121|142898035|SUPERIORITY||Mean Difference (Final Values)|-62.74|||<|0.0001|TWO_SIDED|95.0|-69.01|-56.48||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-56.48|-69.01|<0.0001
71690921|NCT03397121|142898036|SUPERIORITY||Mean Difference (Final Values)|-78.34|||<|0.0001|TWO_SIDED|95.0|-83.65|-73.04||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-73.04|-83.65|<0.0001
71690922|NCT03397121|142898037|SUPERIORITY|LS Mean Difference (95% CI) from Placebo|Mean Difference (Final Values)|-31.77|||<|0.0001|TWO_SIDED|95.0|-35.59|-27.94||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-27.94|-35.59|<0.0001
71690923|NCT03397121|142898038|SUPERIORITY||Mean Difference (Final Values)|-36.06|||<|0.0001|TWO_SIDED|95.0|-39.99|-32.14||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-32.14|-39.99|<0.0001
71690924|NCT03397121|142898039|SUPERIORITY||Mean Difference (Final Values)|-42.36|||<|0.0001|TWO_SIDED|95.0|-47.32|-37.4||The a priori threshold for statistical significance was \<0.05|ANCOVA||Represents the least squares mean difference from Placebo|||-37.40|-47.32|<0.0001
71690925|NCT04085601|142898042|SUPERIORITY||Difference|0.7311|||<|0.0001|TWO_SIDED|95.0|0.572|0.8902||Cochran-Mantel-Haenszel test is stratified by number of packed red blood cell (PRBC) within 12 months prior to screening (\<4, ≥ 4) reported in electronic data capture (EDC) data.|Cochran-Mantel-Haenszel|||||0.8902|0.572|<0.0001
71690926|NCT04085601|142898043|SUPERIORITY||LS mean difference|-1470.38|||<|0.0001|TWO_SIDED|95.0|-2113.44|-827.32||p-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-827.32|-2113.44|<0.0001
71690927|NCT04085601|142898044|SUPERIORITY||Difference|0.5411|||<|0.0001|TWO_SIDED|95.0|0.339|0.7431||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.7431|0.339|<0.0001
71933357|NCT00986154|143387914|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9933|TWO_SIDED|95.0|0.832|1.2|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose.|||1.200|.832|.9933
71933358|NCT00986154|143387915|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.004|TWO_SIDED|95.0|0.705|0.936|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|"Safety Analysis set includes all randomized subjects who received at least one dose of study drug.~Null hypothesis (LMW) heparin/edoxaban will be comparable to (LMW) heparin/warfarin in preventing recurrence of major or clinically relevant non-major bleeding."||.936|.705|.0040
71690928|NCT04085601|142898045|SUPERIORITY||LS mean difference|-103.82||||0.0002|TWO_SIDED|95.0|-158.9|-48.74||P-value for Baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||-48.74|-158.9|0.0002
71690929|NCT04085601|142898046|SUPERIORITY||LS mean difference|2.67||||0.0019|TWO_SIDED|95.0|0.99|4.35||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||4.35|0.99|0.0019
71690930|NCT04085601|142898047|SUPERIORITY||Difference|-0.7505|||<|0.0001|TWO_SIDED|95.0|-0.9041|-0.5969||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||-0.5969|-0.9041|<0.0001
71690931|NCT04085601|142898048|SUPERIORITY||Difference|0.7241|||<|0.0001|TWO_SIDED|95.0|0.5583|0.8899||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.8899|0.5583|<0.0001
71690932|NCT04085601|142898049|SUPERIORITY||Median Difference (Net)|3.0|||<|0.0001|TWO_SIDED|95.0|2.0|4.0||Wilcoxon rank-sum test p-value for the comparison between treatments is based on median using stratified non-parametric analysis. The 95% confidence interval (CI) is constructed using Hodges-Lehmann Estimation of Location Shift.|Wilcoxon Rank-Sum Test|||||4|2|<0.0001
71690933|NCT04085601|142898050|SUPERIORITY||LS mean difference|4.51||||0.061|TWO_SIDED|95.0|-0.21|9.24||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||9.24|-0.21|0.061
71690934|NCT04085601|142898051|SUPERIORITY||Difference|0.3645||||0.001|TWO_SIDED|95.0|0.1648|0.5642|||Cochran-Mantel-Haenszel|||||0.5642|0.1648|0.001
71690935|NCT04085601|142898052|SUPERIORITY||Difference|0.5592|||<|0.0001|TWO_SIDED|95.0|0.3682|0.7502|||Cochran-Mantel-Haenszel|||||0.7502|0.3682|<0.0001
71690936|NCT04085601|142898053|SUPERIORITY||LS mean difference|21.75||||0.0006|TWO_SIDED|95.0|9.35|34.16||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||34.16|9.35|0.0006
71690937|NCT04085601|142898054|SUPERIORITY||LS mean difference|55.79||||0.005|TWO_SIDED|95.0|16.83|94.74||P-value for baseline, strata and treatment is from LS mean of proc mixed and proc mianalyze based on parameter estimates.|ANCOVA|||||94.74|16.83|0.005
71690938|NCT04085601|142898055|SUPERIORITY||Difference|0.4639||||0.0002|TWO_SIDED|95.0|0.2529|0.675||Cochran-Mantel-Haenszel test is stratified by number of PRBC within 12 months prior to screening (\<4, ≥ 4) reported in EDC data.|Cochran-Mantel-Haenszel|||||0.675|0.2529|0.0002
71933359|NCT03726437|143387916|SUPERIORITY|Analyses were performed to determine whether RealConsent was superior to Stress and Mood Management in reducing incidence of sexual violence victimization.|Risk Ratio (RR)|0.48||||0.0002|TWO_SIDED|95.0|0.33|0.69|||Mixed Models Analysis|Models adjusted for fixed effects.||||.69|.33|.0002
71933360|NCT03726437|143387916|SUPERIORITY||Odds Ratio (OR)|0.77||||0.31|TWO_SIDED|95.0|0.47|1.28|||Mixed Models Analysis|Models adjusted for fixed effects.||||1.28|.47|.31
71933361|NCT03726437|143387917|SUPERIORITY||Adjusted OR|1.17||||0.03|TWO_SIDED|95.0|0.12|1.22|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.22|0.12|.03
71933362|NCT03726437|143387918|SUPERIORITY||Adjusted OR|-0.5|||<|0.05|TWO_SIDED|95.0|-1.27|0.27|||Mixed Models Analysis|Model adjusted for fixed effects.||||0.27|-1.27|<.05
71933363|NCT03726437|143387919|SUPERIORITY||Incidence rate ratio|0.81||||0.02|TWO_SIDED|95.0|0.67|0.97|||Mixed Models Analysis|Model adjusted for fixed effects.||||.97|.67|.02
71933364|NCT03726437|143387920|SUPERIORITY||Incidence rate ratio|1.05||||0.43|TWO_SIDED|95.0|0.92|1.2|||Mixed Models Analysis|Model adjusted for fixed effects.||||1.20|.92|.43
71933365|NCT03726437|143387921|SUPERIORITY||Adjusted OR|1.72||||0.006|TWO_SIDED|95.0|1.17|2.55|||Mixed Models Analysis|Model adjusted for fixed effects.||||2.55|1.17|.006
71933366|NCT00068445|143387922|SUPERIORITY|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||||||0.56
71933367|NCT00068445|143387923|SUPERIORITY|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71933368|NCT00068445|143387924|SUPERIORITY|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||||||0.25
71933369|NCT00068445|143387925|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||||||0.34
71933370|NCT00068445|143387926|SUPERIORITY|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||||||0.53
71933371|NCT00068445|143387927|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||||||0.22
71933372|NCT00068445|143387928|SUPERIORITY|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||||||0.33
71933373|NCT00068445|143387929|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||||||0.07
71933374|NCT00068445|143387930|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.91
71933375|NCT00068445|143387931|SUPERIORITY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71933376|NCT03118765|143387941|OTHER|ANOVA|LS mean ratio (%)|29.4|||||TWO_SIDED|90.0|21.14|41.0|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||41.00|21.14|
71933377|NCT03118765|143387941|OTHER|ANOVA|LS mean ratio (%)|57.0|||||TWO_SIDED|90.0|41.37|78.46|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||78.46|41.37|
71933378|NCT03118765|143387941|OTHER|ANOVA|LS mean ratio (%)|155.8|||||TWO_SIDED|90.0|111.88|216.99|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||216.99|111.88|
71933379|NCT03118765|143387942|OTHER|ANOVA|LS mean ratio (%)|39.7|||||TWO_SIDED|90.0|29.79|52.87|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||52.87|29.79|
71933380|NCT03118765|143387942|OTHER|ANOVA|LS mean ratio (%)|85.2|||||TWO_SIDED|90.0|64.43|112.64|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||112.64|64.43|
71933381|NCT03118765|143387942|OTHER|ANOVA|LS mean ratio (%)|211.5|||||TWO_SIDED|90.0|158.8|281.8|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.||281.80|158.80|
71933382|NCT03118765|143387943|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.228|TWO_SIDED|95.0|-0.04|0.17|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.17|-0.04|0.228
71933383|NCT03118765|143387943|SUPERIORITY||Mean Difference (Net)|0.02||||0.655|TWO_SIDED|95.0|-0.08|0.13|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.13|-0.08|0.655
71933384|NCT03118765|143387943|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.894|TWO_SIDED|95.0|-0.1|0.11|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.11|-0.10|0.894
71933385|NCT03118765|143387943|SUPERIORITY||Mean Difference (Final Values)|0.06||||0.26|TWO_SIDED|95.0|-0.04|0.16|||MMRM|||SPIRIVA RESPIMAT 5 μg vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.||0.16|-0.04|0.260
71933386|NCT03118765|143387944|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 10 μg was (Geo mean: 108200 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
71933387|NCT03118765|143387944|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 20 μg was (Geo mean: 263100 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
71933388|NCT03118765|143387944|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 40 μg was (Geo mean: 438300 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).|||
71933389|NCT03118765|143387945|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 10 μg was (Geo mean: 293700 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
71933390|NCT03118765|143387945|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 20 μg was (Geo mean: 436500 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
71933391|NCT03118765|143387945|OTHER||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 40 μg was (Geo mean: 1249000 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).|||
71933392|NCT03118765|143387946|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 1.082% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
71690939|NCT04085601|142898056|SUPERIORITY||Stratified Hazard Ratio|0.02|||<|0.0001|TWO_SIDED|95.0|0.004|0.091||Hazard ratio is based on cox proportional hazards model.|Stratified Wilcoxon|||||0.091|0.004|<0.0001
71690940|NCT04085601|142898057|SUPERIORITY||Stratified Hazard Ratio|0.025|||<|0.0001|TWO_SIDED|95.0|0.005|0.121|||Stratified Wilcoxon|||||0.121|0.005|<0.0001
71690941|NCT03492437|142898058|OTHER||Ratio of Geometric Least square Mean|151.38|||||TWO_SIDED|90.0|127.35|179.93||||||||179.93|127.35|
71690942|NCT03492437|142898059|OTHER||Ratio of Geometric Least square Mean|144.7|||||TWO_SIDED|90.0|122.89|170.39||||||||170.39|122.89|
71690943|NCT03492437|142898060|OTHER||Ratio of Geometric Least square Mean|138.45|||||TWO_SIDED|90.0|121.59|157.65||||||||157.65|121.59|
71690944|NCT03492437|142898061|OTHER||Median Difference (Net)|0.5|||||TWO_SIDED|90.0|-0.3|1.0||||||||1.0|-0.3|
71690945|NCT02418234|142898072|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||||||<0.05
71690946|NCT02418234|142898073|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71933393|NCT03118765|143387946|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 1.316% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
71933394|NCT03118765|143387946|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 1.096% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1|||
71933395|NCT03118765|143387947|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 2.937% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
71933396|NCT03118765|143387947|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 2.183% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
71690947|NCT04534517|142898074|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 32 points|Mean Estimate|58.6|STANDARD_DEVIATION|3.26|||TWO_SIDED|95.0|52.3|64.9|||Bayesian multivariate random-effects||Included Hyperope group only|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||64.9|52.3|
71933397|NCT03118765|143387947|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 3.123% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21|||
71933398|NCT03118765|143387948|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean Cmax of tiotropium was 2.191 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
71690948|NCT04534517|142898074|SUPERIORITY|The superiority of the Test lens was concluded if the lower credible limit of the mean was above the pre-defined threshold 40 points for Myopes|Mean Estimate|63.8|STANDARD_DEVIATION|2.97|||TWO_SIDED|95.0|57.9|69.6|||Bayesian multivariate random-effects||Included myope group only.|It was calculated that 60 participants would have \> 99% power to for the mean CLUE vision scores for each sphere stratum to be above the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||69.6|57.9|
71690949|NCT04534517|142898075|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.10 logMAR for Distance|Mean estimate|-0.09|STANDARD_DEVIATION|0.0172|||TWO_SIDED|95.0|-0.125|-0.057|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.057|-0.125|
71690950|NCT04534517|142898075|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Intermediate|Mean Estimate|-0.057|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|-0.091|-0.024|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||-0.024|-0.091|
71690951|NCT04534517|142898075|SUPERIORITY|The superiority of the Test lens was concluded if the upper credible limit of the mean was below the pre-defined threshold +0.17 logMAR for Near|Mean Estimate|0.066|STANDARD_DEVIATION|0.0171|||TWO_SIDED|95.0|0.031|0.098|||Bayesian normal random-effects model|Repeated Measures||It was calculated that 60 participants would have \> 99% power to for the mean visual performance at each distance to be below the hypothesis threshold at the 2-week follow-up. Sample size was determined using one sample means test for equivalence||0.098|0.031|
71690952|NCT04534517|142898076|SUPERIORITY|A superiority margin of 5% was used. Upper limit of 95% credible interval was compared to 5%.|Mean Proportion|0.001|STANDARD_DEVIATION|0.0012|||TWO_SIDED|95.0|0.0|0.004|||Bayesian beta-binomial model|Correlated Binary Data||||0.004|0.000|
71690953|NCT04534517|142898077|SUPERIORITY|A superiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Proportion|0.005|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|0.0|0.018|||Bayesian beta-binomial model|Correlated Binary Data||||0.018|0.000|
71690954|NCT04534517|142898078|SUPERIORITY|A superiority margin of 90% was used. Lower limit of the 95% credible interval was compared to 90%|Mean Proportion|0.992|STANDARD_DEVIATION|0.0072|||TWO_SIDED|95.0|0.973|0.999|||Bayesian beta-binomial model|Correlated Binary Data||||0.999|0.973|
71690955|NCT00823264|142898082|SUPERIORITY_OR_OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71690956|NCT05133323|142898083|SUPERIORITY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|0.89||0.0106|ONE_SIDED|90.0||-0.6|||ANCOVA|||||-0.6||0.0106
71933399|NCT03118765|143387948|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean Cmax of tiotropium was 4.796 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
71933400|NCT03118765|143387948|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean Cmax of tiotropium was 10.2 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.|||
71933401|NCT03118765|143387949|OTHER||||||||||||||||||For GSP304 10 μg, geometric mean AUC0-tau of tiotropium was 8.597 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
71933402|NCT03118765|143387949|OTHER||||||||||||||||||For GSP304 20 μg, geometric mean AUC0-tau of tiotropium was 18.00 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
71933403|NCT03118765|143387949|OTHER||||||||||||||||||For GSP304 40 μg, geometric mean AUC0-tau of tiotropium was 42.69 pg\*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg\*h/mL on Day 1.|||
71933404|NCT03118765|143387952|OTHER||||||||||||||||||For GSP304 10 μg, the geometric mean CavSS was 0.9536 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
71933405|NCT03118765|143387952|OTHER||||||||||||||||||For GSP304 20 μg, the geometric mean CavSS was 1.998 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
71933406|NCT03118765|143387952|OTHER||||||||||||||||||For GSP304 40 μg, the geometric mean CavSS was 5.083 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21|||
71933407|NCT03118765|143387953|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.617 for GSP304 10 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
71933408|NCT03118765|143387953|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.522 for GSP304 20 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
71933409|NCT03118765|143387953|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.926 for GSP304 40 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.|||
71933410|NCT03118765|143387954|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.944 for GSP304 10 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
71933411|NCT03118765|143387954|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.808 for GSP304 20 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
71933412|NCT03118765|143387954|OTHER||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 2.125 for GSP304 40 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.|||
71933413|NCT03118765|143387955|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.004|TWO_SIDED|95.0|0.04|0.21|||Mixed Models Analysis|||||0.21|0.04|0.004
71933414|NCT03118765|143387955|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
71933415|NCT03118765|143387955|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.007|TWO_SIDED|95.0|0.03|0.21|||Mixed Models Analysis|||||0.21|0.03|0.007
71933416|NCT03118765|143387955|SUPERIORITY||Mean Difference (Final Values)|0.17|||<|0.001|TWO_SIDED|95.0|0.08|0.26|||Mixed Models Analysis|||||0.26|0.08|<0.001
71933417|NCT03118765|143387956|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.001|TWO_SIDED|95.0|0.08|0.28|||Mixed Models Analysis|||||0.28|0.08|0.001
71933418|NCT03118765|143387956|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.005|TWO_SIDED|95.0|0.05|0.25|||Mixed Models Analysis|||||0.25|0.05|0.005
71933419|NCT03118765|143387956|SUPERIORITY||Mean Difference (Final Values)|0.11||||0.032|TWO_SIDED|95.0|0.01|0.21|||Mixed Models Analysis|||||0.21|0.01|0.032
71933420|NCT03118765|143387956|SUPERIORITY||Mean Difference (Final Values)|0.17||||0.001|TWO_SIDED|95.0|0.07|0.27|||Mixed Models Analysis|||||0.27|0.07|0.001
71933421|NCT03118765|143387957|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.166|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.166
71933422|NCT03118765|143387957|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.182|TWO_SIDED|95.0|-0.04|0.21|||Mixed Models Analysis|||||0.21|-0.04|0.182
71933423|NCT03118765|143387957|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.401|TWO_SIDED|95.0|-0.07|0.17|||Mixed Models Analysis|||||0.17|-0.07|0.401
71933424|NCT03118765|143387957|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.574|TWO_SIDED|95.0|-0.09|0.16|||Mixed Models Analysis|||||0.16|-0.09|0.574
71933425|NCT03118765|143387958|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.493|TWO_SIDED|95.0|-0.1|0.21|||Mixed Models Analysis|||||0.21|-0.10|0.493
71933426|NCT03118765|143387958|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.864|TWO_SIDED|95.0|-0.17|0.14|||Mixed Models Analysis|||||0.14|-0.17|0.864
71933427|NCT03118765|143387958|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.978|TWO_SIDED|95.0|-0.16|0.15|||Mixed Models Analysis|||||0.15|-0.16|0.978
71933428|NCT03118765|143387958|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.5|TWO_SIDED|95.0|-0.1|0.2|||Mixed Models Analysis|||||0.20|-0.10|0.500
71933429|NCT03118765|143387959|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.003|TWO_SIDED|95.0|0.04|0.2|||Mixed Models Analysis|||||0.20|0.04|0.003
71933430|NCT03118765|143387959|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.001|TWO_SIDED|95.0|0.06|0.22|||Mixed Models Analysis|||||0.22|0.06|0.001
71933431|NCT03118765|143387959|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.001|TWO_SIDED|95.0|0.06|0.21|||Mixed Models Analysis|||||0.21|0.06|0.001
71933432|NCT03118765|143387959|SUPERIORITY||Mean Difference (Final Values)|0.16|||<|0.001|TWO_SIDED|95.0|0.08|0.23|||Mixed Models Analysis|||||0.23|0.08|<0.001
71933433|NCT03118765|143387960|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
71933434|NCT03118765|143387960|SUPERIORITY||Mean Difference (Final Values)|0.09||||0.061|TWO_SIDED|95.0|0.0|0.18|||Mixed Models Analysis|||||0.18|-0.00|0.061
71933435|NCT03118765|143387960|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.14|TWO_SIDED|95.0|-0.02|0.16|||Mixed Models Analysis|||||0.16|-0.02|0.140
71933436|NCT03118765|143387960|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.002|TWO_SIDED|95.0|0.06|0.24|||Mixed Models Analysis|||||0.24|0.06|0.002
71933437|NCT00947518|143387966|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED|95.0|||||Kruskal-Wallis|||||||0.99
71933438|NCT00947518|143387967|SUPERIORITY_OR_OTHER|||||||0.46||95.0|||||ANOVA|||||||0.46
71933439|NCT00947518|143387968|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Chi-squared|||||||0.06
71933440|NCT00947518|143387969|SUPERIORITY||||||<|0.05|||||||Chi-squared||||For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni's correction was used.|||<0.05
71933441|NCT02713243|143388004|SUPERIORITY||Mean Difference (Net)|4.04||||0.01|TWO_SIDED|95.0|0.98|7.11|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||7.11|0.98|0.01
71933442|NCT02713243|143388004|SUPERIORITY||Mean Difference (Net)|1.31||||0.401|TWO_SIDED|95.0|-1.77|4.38|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||4.38|-1.77|0.401
71933443|NCT02713243|143388004|SUPERIORITY||Mean Difference (Net)|2.67||||0.019|TWO_SIDED|95.0|0.46|4.89|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||4.89|0.46|0.019
71933444|NCT02713243|143388009|SUPERIORITY||Mean Difference (Net)|0.12||||0.533|TWO_SIDED|95.0|-0.27|0.52|||Mixed Models Analysis|||Week 1 (Period 1 \& 2)||0.52|-0.27|0.533
71933445|NCT02713243|143388009|SUPERIORITY||Mean Difference (Net)|-0.09||||0.64|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Week 2 (Period 1 \& 2)||0.30|-0.49|0.640
71933446|NCT02713243|143388009|SUPERIORITY||Mean Difference (Net)|0.02||||0.916|TWO_SIDED|95.0|-0.27|0.3|||Mixed Models Analysis|||Week 1\&2 (Period 1 \& 2)||0.30|-0.27|0.916
71933447|NCT00204932|143388012|NON_INFERIORITY_OR_EQUIVALENCE|Power analysis was based on test-retest variance of body fat mass measure by DEXA|||||<|0.05||95.0|||||ANOVA|||Analysis of variance to test CLA not equal to placebo||||<0.05
71933448|NCT00204932|143388012|SUPERIORITY||||||<|0.05|||||||ANOVA|||Pre- post treatment comparison o fat oxidation found that fat oxidation increased in CLA (4 +/- 8 g) and decreased in placebo (-7 +/- 11 g) groups during sleep. after 6 mo of supplementation.||||<0.05
71933449|NCT05788237|143388043|OTHER||GMR|0.84|||||TWO_SIDED|95.0|0.662|1.062||||||GMR for RSV A: RSVpreF + qIRV combination to RSVpreF alone.||1.062|0.662|
71933450|NCT05788237|143388043|OTHER||GMR|0.79|||||TWO_SIDED|95.0|0.614|1.013||||||GMR for RSV B: RSVpreF + qIRV combination to RSVpreF alone.||1.013|0.614|
71933451|NCT05788237|143388044|OTHER||GMR|0.81|||||TWO_SIDED|95.0|0.632|1.044||||||GMR for HAI: H1N1 A/Wisconsin: RSVpreF + qIRV combination to RSVpreF alone.||1.044|0.632|
71933452|NCT05788237|143388044|OTHER||Geometric Mean Ratio|0.74|||||TWO_SIDED|95.0|0.567|0.957||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV combination to RSVpreF alone.||0.957|0.567|
71933453|NCT05788237|143388044|OTHER||GMR|0.94|||||TWO_SIDED|95.0|0.741|1.181||||||GMR for HAI: B/Austria: RSVpreF + qIRV combination to RSVpreF alone.||1.181|0.741|
71933454|NCT05788237|143388044|OTHER||GMR|0.91|||||TWO_SIDED|95.0|0.707|1.174||||||GMR for HAI: B/Phuket: RSVpreF + qIRV combination to RSVpreF alone.||1.174|0.707|
71933455|NCT05788237|143388045|OTHER||Geometric Mean Ratio|1.05|||||TWO_SIDED|95.0|0.82|1.339||||||GMR for RSV A: RSVpreF + qIRV 1.0 mL (Group 1) combination to RSVpreF + qIRV 0.5 mL (Group 2)||1.339|0.820|
71933456|NCT05788237|143388045|OTHER||Geometric Mean Ratio|1.06|||||TWO_SIDED|95.0|0.833|1.352||||||GMR for RSV B: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.352|0.833|
71933457|NCT05788237|143388046|OTHER||GMR|1.19|||||TWO_SIDED|95.0|0.875|1.614||||||GMR for HAI: H1N1 A/Sydney: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.614|0.875|
71933458|NCT05788237|143388046|OTHER||Geometric Mean Ratio|1.13|||||TWO_SIDED|95.0|0.867|1.473||||||GMR for HAI: H3N2 A/Darwin: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.473|0.867|
71933459|NCT05788237|143388046|OTHER||Geometric Mean Ratio|1.08|||||TWO_SIDED|95.0|0.849|1.383||||||GMR for HAI: B/Austria: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.383|0.849|
71933460|NCT05788237|143388046|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.866|1.392||||||GMR for HAI: B/Phuket: RSVpreF + qIRV 1.0 mL (Group 1) to RSVpreF + qIRV 0.5 mL (Group 2)||1.392|0.866|
71933461|NCT01335399|143388080|SUPERIORITY|||||||0.4358|||||||Stratified Log Rank|||||||0.4358
71933462|NCT01335399|143388080|SUPERIORITY||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.71|0.77|1.12|||||E-Ld/Ld. Calculated using Cox proportional hazards modeling|||1.12|0.77|
71933463|NCT01335399|143388081|SUPERIORITY||CMH ESTIMATE OF COMMON ODDS RATIO|1.26||||0.2232|TWO_SIDED|95.0|0.87|1.82|||CMH ESTIMATE OF COMMON ODDS RATIO|||||1.82|0.87|0.2232
71933464|NCT01335399|143388082|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.8932|TWO_SIDED|95.0|0.82|1.19|||Stratified log rank test||Stratified by stage of disease (International Staging System 1 - 2 vs 3), age (\<75 years old vs \>= 75 years old) and ECOG performance status (0 vs 1 - 2) at randomization.|||1.19|0.82|0.8932
71933465|NCT01335399|143388084|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.4358|TWO_SIDED|95.0|0.78|1.12|||Hazard Ratio|||||1.12|0.78|0.4358
71933466|NCT02464059|143388085|SUPERIORITY||Mean Difference (Final Values)|-65.5|STANDARD_DEVIATION|207.8||0.21|TWO_SIDED|95.0|-172.4|41.3||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||41.3|-172.4|0.21
71933467|NCT02464059|143388086|SUPERIORITY||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|12.6||0.86|TWO_SIDED|95.0|-7.02|5.91||P-value is not adjusted for multiple comparisons. A priori threshold for significance is p\<0.05.|t-test, 2 sided|||||5.91|-7.02|0.86
71933468|NCT03990389|143388096|SUPERIORITY|||||||0.0618||||||Three degrees of freedom for the interaction test|Mixed Models Analysis|||||||0.0618
71933469|NCT03990389|143388096|SUPERIORITY||estimated treatment effect at month 1|-2.29|STANDARD_ERROR_OF_MEAN|1.8||0.63|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.63
71933470|NCT03990389|143388096|SUPERIORITY||estimated treatment effect at month 2|-5.19|STANDARD_ERROR_OF_MEAN|1.9||0.018|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.018
71933471|NCT03990389|143388096|SUPERIORITY||estimated treatment effect at month 3|-3.3|STANDARD_ERROR_OF_MEAN|1.9||0.234|TWO_SIDED|||||Bonferroni correction for 3 times points|Mixed Models Analysis|||||||0.234
71933472|NCT03990389|143388097|OTHER|||||||0.116|||||||t-test, 2 sided|||||||0.116
71933473|NCT02290028|143388102|SUPERIORITY||||||<|0.0001|||||||Exact, binomial|||Primary endpoint 1 was evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 6 months) to the performance goal of 90.0%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 90.0%.||||<0.0001
71933474|NCT02290028|143388103|SUPERIORITY||||||=|0.002|||||||Exact, binomial|||Primary endpoint 2 was evaluated by performing an exact, binomial test comparing an observed proportion (rate of acceptable LV pacing thresholds at the permanently programmed pacing vector at 3 months) to 88%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the percentage of subjects with an acceptable LV pacing threshold in the permanently programmed pacing vector must be greater than 88.0%.||||=0.002
71933475|NCT02290028|143388104|SUPERIORITY|||||||||||||||||Primary endpoint 3 will be evaluated by performing an exact, binomial test comparing the observed proportion (overall complication-free rate at 5 years) to the performance goal of 92.5%, with Type I error (alpha) of 0.025 and power of 80%. The lower, two-sided 95% confidence bound for the overall complication-free rate must be greater than 92.5%|On September 24, 2019, BIOTRONIK received FDA approval to transition the ongoing Sentus Post Approval Registry to a new EP PASSION real-world data methodology. As of study closure, the number of subjects with complete data required to perform the hypothesis test was not met. Therefore, this outcome measure was not analyzed.|||
71933476|NCT03202511|143388113|EQUIVALENCE|0.8 to 1.25 equivalence margin was used.|Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.47|1.77||||||||1.77|1.47|
71933477|NCT03202511|143388114|EQUIVALENCE|80 to 125% equivalence margin was used.|Geometric Mean Ratio|77.4|||||TWO_SIDED|90.0|61.4|97.6||||||||97.6|61.4|
71933478|NCT01735877|143388117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|1.52||0.77|||||||t-test, 2 sided|||At Baseline||||0.77
71933479|NCT01735877|143388117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.12|||<|0.0001|TWO_SIDED|95.0|11.02|17.25|||ANCOVA|||Mean Change from baseline to 1 month||17.25|11.02|<0.0001
71933480|NCT01735877|143388117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.56|||<|0.0001|TWO_SIDED|95.0|18.65|26.48|||ANCOVA|||Baseline to 3 month||26.48|18.65|<0.0001
71933481|NCT01735877|143388117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.28|||<|0.0001|TWO_SIDED|95.0|18.94|27.62|||ANCOVA|||Baseline to 6 month||27.62|18.94|<0.0001
71933482|NCT01735877|143388118|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
71933483|NCT01735877|143388118|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At 1 month||||0.99
71933484|NCT01735877|143388118|SUPERIORITY_OR_OTHER|||||||0.03|||||||Chi-squared|||At 3 months||||0.03
71933485|NCT01735877|143388118|SUPERIORITY_OR_OTHER|||||||0.004|||||||Chi-squared|||At 6 months||||0.004
71933486|NCT01735877|143388119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.51|STANDARD_ERROR_OF_MEAN|3.25||0.64|||||||t-test, 2 sided|||At Baseline||||0.64
71933487|NCT01735877|143388119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.92||||0.002|TWO_SIDED|95.0|2.24|9.6|||ANCOVA|||Mean change from baseline to 1 month||9.60|2.24|0.002
71933488|NCT01735877|143388119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.71||||0.005|TWO_SIDED|95.0|2.8|14.63|||ANCOVA|||Mean change from baseline to 3 month||14.63|2.80|0.005
71933489|NCT01735877|143388119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.63||||0.006|TWO_SIDED|95.0|2.67|14.6|||ANCOVA|||Mean change from baseline to 6 month||14.60|2.67|0.006
71933490|NCT01735877|143388120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.64|STANDARD_ERROR_OF_MEAN|0.24||0.99|||||||t-test, 2 sided|||Baseline||||0.99
71933491|NCT01735877|143388120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.68|||<|0.0001|TWO_SIDED|95.0|2.93|4.42|||ANCOVA|||Mean change from baseline to 1 month||4.42|2.93|<0.0001
71933492|NCT01735877|143388120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||<|0.0001|TWO_SIDED|95.0|2.61|4.21|||ANCOVA|||Mean change from baseline to 3 month||4.21|2.61|<0.0001
71933493|NCT01735877|143388120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.21|||<|0.0001|TWO_SIDED|95.0|2.4|4.02|||ANCOVA|||Mean change from baseline to 6 month||4.02|2.40|<0.0001
71933494|NCT01735877|143388121|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At Baseline||||0.99
71933495|NCT01735877|143388121|SUPERIORITY_OR_OTHER|||||||0.99|||||||Chi-squared|||At month 1||||0.99
71933496|NCT01735877|143388121|SUPERIORITY_OR_OTHER|||||||0.04|||||||Chi-squared|||At month 3||||0.04
71933497|NCT01735877|143388121|SUPERIORITY_OR_OTHER|||||||0.01|||||||Chi-squared|||At month 6||||0.01
71933498|NCT00331773|143388189|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio \[HR\] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.|Hazard Ratio (HR)|0.85|||<|0.001|TWO_SIDED|95.0|0.64|1.14|||Log Rank||Reference arm = Conventional 3D-CRT|||1.14|0.64|<0.001
71933499|NCT00331773|143388192|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.77|||<|0.001|TWO_SIDED|95.0|0.51|1.17|||Log Rank||Reference arm = Conventional 3D-CRT|||1.17|0.51|< 0.001
71933500|NCT00331773|143388193|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.95||||0.008|TWO_SIDED|95.0|0.64|1.41|||Log Rank||Reference arm = Conventional 3D-CRT|||1.41|0.64|0.008
71933501|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.85|TWO_SIDED|95.0|0.73|1.46||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.||1.46|0.73|0.85
71933502|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.72|TWO_SIDED|95.0|0.29|5.81||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||5.81|0.29|0.72
71933503|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.99||||0.95|TWO_SIDED|95.0|0.82|1.21||2-sided|Regression, Logistic||Reference Arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.21|0.82|0.95
71933504|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.36||||0.39|TWO_SIDED|95.0|0.67|2.74||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.74|0.67|0.39
71933505|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.59||||0.005|TWO_SIDED|95.0|1.22|2.06||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.06|1.22|0.005
71933506|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.55||||0.19|TWO_SIDED|95.0|0.8|2.99||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||2.99|0.80|0.19
71933507|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.31||||0.009|TWO_SIDED|95.0|1.07|1.61||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||1.61|1.07|0.009
71933508|NCT00331773|143388194|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.56||||0.22|TWO_SIDED|95.0|0.76|3.18||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as \< grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.||3.18|0.76|0.22
71933509|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 6 months||||0.72
71933510|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.056|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 6 months||||0.056
71933511|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 6 months||||0.99
71933512|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 6 months||||0.49
71933513|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0037|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 12 months||||0.0037
71933514|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 12 months||||0.062
71933515|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 12 months||||0.94
71933516|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 12 months||||0.93
71933517|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 24 months||||0.12
71933518|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 24 months||||0.81
71933519|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 24 months||||0.69
71933520|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 24 months||||0.68
71933521|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 60 months||||0.071
71933522|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 60 months||||0.047
71933523|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 60 months||||0.4
71933524|NCT00331773|143388195|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 60 months||||0.91
71933525|NCT00331773|143388197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.55
71933526|NCT00331773|143388197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.29
71933527|NCT00331773|143388197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.23
71933528|NCT00331773|143388197|SUPERIORITY_OR_OTHER_LEGACY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.||||0.028
71933529|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.037|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level = 0.05||Baseline VAS score||||0.037
71933530|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||Baseline index score||||0.12
71933531|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month VAS score||||0.70
71933532|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month index score||||0.20
71933533|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.31||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month VAS score||||0.31
71933534|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month index score||||0.19
71933535|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month VAS score||||0.86
71933536|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.45||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month index score||||0.45
71933537|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.39||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month VAS score||||0.39
71690957|NCT00113295|142898087|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3|||<|0.05||||||No adjustment for multiple testing|t-test, 2 sided||This analysis applies to the additional reduction from phase 2 randomization to phase 2 endpoint in HAM-A scores.|In phase 2, comprising randomized double-blind quetiapine augmentation, change scores were examined with two-tailed, two-sample t tests, utilizing scores at phase 2 randomization as baseline. All analyses were intention to treat (ITT) with the last visit carried forward (LVCF) for subjects that did not complete the study.||||<0.05
71690958|NCT00572455|142898099|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|3.02||||0.028|TWO_SIDED|90.0|0.78|5.25|||ANCOVA|||Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.25|0.78|0.028
71690959|NCT00572455|142898099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.73|||<|0.001|TWO_SIDED|90.0|2.5|6.96|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.96|2.50|<0.001
71690960|NCT00572455|142898099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.56|||<|0.001|TWO_SIDED|90.0|4.33|8.79|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.79|4.33|<0.001
71690961|NCT00572455|142898099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.78|||<|0.001|TWO_SIDED|90.0|3.6|7.95|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.95|3.60|<0.001
71690962|NCT00572455|142898099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.06|||<|0.001|TWO_SIDED|90.0|2.74|7.37|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.37|2.74|<0.001
71690963|NCT00572455|142898099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.02|||<|0.001|TWO_SIDED|90.0|3.79|8.25|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.25|3.79|<0.001
71933538|NCT00331773|143388198|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month index score||||0.56
71933539|NCT00830063|143388206|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.76|-0.72||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.||-0.72|-1.76|<0.001
71690964|NCT00572455|142898100|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.06||||0.171|TWO_SIDED|90.0|-0.21|2.32|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.32|-0.21|0.171
71690965|NCT00572455|142898100|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.553|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.553
71933540|NCT00830063|143388206|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.0|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-1.52|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.52|<0.001
71933541|NCT00830063|143388206|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|0.26||0.007|TWO_SIDED|95.0|-1.23|-0.2||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.20|-1.23|0.007
71933542|NCT00830063|143388206|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.26||0.068|TWO_SIDED|95.0|-0.99|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.99|0.068
71690966|NCT00572455|142898100|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.45||||0.555|TWO_SIDED|90.0|-0.8|1.7|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.70|-0.80|0.555
71690967|NCT00572455|142898100|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.053|TWO_SIDED|90.0|0.22|2.73|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.73|0.22|0.053
71690968|NCT00572455|142898100|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.54|||<|0.001|TWO_SIDED|90.0|1.29|3.8|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.80|1.29|<0.001
71690969|NCT00572455|142898100|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.81||||0.018|TWO_SIDED|90.0|0.56|3.07|||ANCOVA|||Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.07|0.56|0.018
71690970|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.62||||0.011|TWO_SIDED|90.0|1.34|5.9|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.90|1.34|0.011
71690971|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.19||||0.004|TWO_SIDED|90.0|1.91|6.47|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.47|1.91|0.004
71690972|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.47|||<|0.001|TWO_SIDED|90.0|4.19|8.75|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|4.19|<0.001
71933543|NCT00830063|143388207|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.73|-0.77||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.77|-1.73|<0.001
71933544|NCT00830063|143388207|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.51|-0.55||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.55|-1.51|<0.001
71933545|NCT00830063|143388207|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.76|STANDARD_ERROR_OF_MEAN|0.24||0.002|TWO_SIDED|95.0|-1.24|-0.28||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.28|-1.24|0.002
71933546|NCT00830063|143388207|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|0.24||0.03|TWO_SIDED|95.0|-1.01|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-1.01|0.030
71933547|NCT00830063|143388208|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-0.5|-0.16||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.16|-0.50|<0.001
71933548|NCT00830063|143388208|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.09||0.014|TWO_SIDED|95.0|-0.39|-0.04||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.04|-0.39|0.014
71933549|NCT00830063|143388208|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.026|TWO_SIDED|95.0|-0.36|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.36|0.026
71933550|NCT00830063|143388208|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.09||0.349|TWO_SIDED|95.0|-0.25|0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.09|-0.25|0.349
71933551|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
71933552|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
71933553|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
71933554|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
71933555|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
71933556|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.13|-2.07|<0.001
71690973|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.32|||<|0.001|TWO_SIDED|90.0|3.11|7.54|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.54|3.11|<0.001
71690974|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.0|||<|0.001|TWO_SIDED|90.0|3.66|8.33|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|3.66|<0.001
71690975|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.8|||<|0.001|TWO_SIDED|90.0|3.52|8.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.08|3.52|<0.001
71690976|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.44||||0.12|TWO_SIDED|90.0|-0.14|5.02|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|-0.14|0.120
71690977|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.005|TWO_SIDED|90.0|1.97|7.14|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.14|1.97|0.005
71690978|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.17|||<|0.001|TWO_SIDED|90.0|3.58|8.75|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.75|3.58|<0.001
71690979|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.03|||<|0.001|TWO_SIDED|90.0|3.52|8.54|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.54|3.52|<0.001
71690980|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.31|||<|0.001|TWO_SIDED|90.0|4.66|9.95|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.95|4.66|<0.001
71690981|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.5|||<|0.001|TWO_SIDED|90.0|2.91|8.08|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.||8.08|2.91|<0.001
71690982|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.04||||0.009|TWO_SIDED|90.0|1.56|6.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.53|1.56|0.009
71933557|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
71933558|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
71690983|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.0|||<|0.001|TWO_SIDED|90.0|4.49|9.5|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.49|<0.001
71690984|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.61|||<|0.001|TWO_SIDED|90.0|5.11|10.11|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.11|5.11|<0.001
71690985|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.64|9.53|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.53|4.64|<0.001
71690986|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.01|||<|0.001|TWO_SIDED|90.0|3.4|8.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.62|3.40|<0.001
71690987|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|8.7|||<|0.001|TWO_SIDED|90.0|6.11|11.3|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.30|6.11|<0.001
71690988|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.66||||0.066|TWO_SIDED|90.0|0.29|5.02|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.02|0.29|0.066
71690989|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.13||||0.006|TWO_SIDED|90.0|1.76|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.76|0.006
71690990|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.13|||<|0.001|TWO_SIDED|90.0|3.76|8.49|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.49|3.76|<0.001
71690991|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.81|||<|0.001|TWO_SIDED|90.0|3.51|8.11|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.51|<0.001
71933559|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
71933560|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
71933561|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
71933562|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||Slope|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
71933563|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.07|-2.12|<0.001
71933564|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.85|-1.90|<0.001
71933565|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
71933566|NCT00830063|143388209|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
71933567|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
71933568|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
71933569|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
71933570|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
71933571|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.98|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.45|-0.52||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.52|-1.45|<0.001
71933572|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.02|-1.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.10|-2.02|<0.001
71933573|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.361|TWO_SIDED|95.0|-0.68|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.68|0.361
71933574|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.79|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.25|-0.33||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.33|-1.25|<0.001
71933575|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.06|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.54|-0.59||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.59|-1.54|<0.001
71933576|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.57|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.04|-1.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.09|-2.04|<0.001
71933577|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.063|TWO_SIDED|95.0|-0.93|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.93|0.063
71933578|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.43|-0.48||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.48|-1.43|<0.001
71933579|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.2|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.7|-0.71||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.71|-1.70|<0.001
71933580|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.85|-0.86||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.86|-1.85|<0.001
71933581|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.25||0.006|TWO_SIDED|95.0|-1.19|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-1.19|0.006
71933582|NCT00830063|143388210|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.34|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.34|<0.001
71933583|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.24||0.355|TWO_SIDED|95.0|-0.69|0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.25|-0.69|0.355
71933584|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.57|STANDARD_ERROR_OF_MEAN|0.24||0.017|TWO_SIDED|95.0|-1.04|-0.1||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.10|-1.04|0.017
71933585|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56|STANDARD_ERROR_OF_MEAN|0.24||0.02|TWO_SIDED|95.0|0.09|1.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||1.03|0.09|0.020
71933586|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.21|STANDARD_ERROR_OF_MEAN|0.24||0.388|TWO_SIDED|95.0|-0.26|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.26|0.388
71933587|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.65|-0.7||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.70|-1.65|<0.001
71933588|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.6|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.07|-1.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-1.13|-2.07|<0.001
71933589|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.24||0.274|TWO_SIDED|95.0|-0.73|0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.21|-0.73|0.274
71933590|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.24||0.004|TWO_SIDED|95.0|-1.16|-0.22||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.22|-1.16|0.004
71933591|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.25|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-1.74|-0.75||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.75|-1.74|<0.001
71933592|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.25|<|0.001|TWO_SIDED|95.0|-2.0|-1.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.01|-2.00|<0.001
71933593|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.49|STANDARD_ERROR_OF_MEAN|0.25||0.051|TWO_SIDED|95.0|-0.99|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.00|-0.99|0.051
71933594|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.75|STANDARD_ERROR_OF_MEAN|0.25||0.003|TWO_SIDED|95.0|-1.24|-0.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.25|-1.24|0.003
71933595|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||-1.59|-1.59|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-2.12|-1.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.07|-2.12|<0.001
71933596|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.37|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.9|-0.85||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.85|-1.90|<0.001
71933597|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.89|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-1.42|-0.37||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.37|-1.42|<0.001
71933598|NCT00830063|143388211|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.27||0.012|TWO_SIDED|95.0|-1.19|-0.15||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.15|-1.19|0.012
71933599|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.23||0.026|TWO_SIDED|95.0|-0.96|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.96|0.026
71933600|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.32|-0.43||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.43|-1.32|<0.001
71933601|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22|STANDARD_ERROR_OF_MEAN|0.23||0.333|TWO_SIDED|95.0|-0.23|0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.67|-0.23|0.333
71933602|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.23||0.527|TWO_SIDED|95.0|-0.59|0.3||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.30|-0.59|0.527
71933603|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.03|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.48|-0.57||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.57|-1.48|<0.001
71690992|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.02||||0.01|TWO_SIDED|90.0|1.53|6.5|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.50|1.53|0.010
71933604|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.71|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-2.16|-1.25||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.25|-2.16|<0.001
71933605|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13|STANDARD_ERROR_OF_MEAN|0.23||0.574|TWO_SIDED|95.0|-0.58|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|-0.58|0.574
71933606|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.81|STANDARD_ERROR_OF_MEAN|0.23|<|0.001|TWO_SIDED|95.0|-1.26|-0.36||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.36|-1.26|<0.001
71933607|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.6|-0.67||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.67|-1.60|<0.001
71933608|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-2.1|-1.17||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-1.17|-2.10|<0.001
71933609|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.24||0.055|TWO_SIDED|95.0|-0.92|0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.01|-0.92|0.055
71933610|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.42|-0.49||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.49|-1.42|<0.001
71933611|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.27|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.75|-0.79||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.79|-1.75|<0.001
71933612|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.95|-0.99||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.99|-1.95|<0.001
71933613|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.67|STANDARD_ERROR_OF_MEAN|0.24||0.006|TWO_SIDED|95.0|-1.15|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-1.15|0.006
71933614|NCT00830063|143388212|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.87|STANDARD_ERROR_OF_MEAN|0.24|<|0.001|TWO_SIDED|95.0|-1.34|-0.39||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.39|-1.34|<0.001
71933615|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
71933616|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
71933617|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
71933618|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
71933619|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.66|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.66|<0.001
71690993|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.48|||<|0.001|TWO_SIDED|90.0|3.03|7.93|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.93|3.03|<0.001
71933620|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.72|-0.41||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.41|-0.72|<0.001
71933621|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.041|TWO_SIDED|95.0|-0.32|-0.01||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.01|-0.32|0.041
71933622|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.38|-0.06||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.06|-0.38|0.006
71933623|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.44|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.27||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.27|-0.60|<0.001
71933624|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.62|-0.29||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.29|-0.62|<0.001
71933625|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.08||0.011|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.011
71933626|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.23|STANDARD_ERROR_OF_MEAN|0.08||0.006|TWO_SIDED|95.0|-0.4|-0.07||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.07|-0.40|0.006
71933627|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.43|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.6|-0.26||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.26|-0.60|<0.001
71933628|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.48|-0.14||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference||-0.14|-0.48|<0.001
71933629|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.42|-0.09||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.09|-0.42|0.003
71933630|NCT00830063|143388213|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.105|TWO_SIDED|95.0|-0.3|0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.03|-0.30|0.105
71933631|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.08||0.045|TWO_SIDED|95.0|-0.32|0.0||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.00|-0.32|0.045
71933632|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.03|TWO_SIDED|95.0|-0.33|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.33|0.030
71933633|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.18|STANDARD_ERROR_OF_MEAN|0.08||0.027|TWO_SIDED|95.0|0.02|0.34||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.34|0.02|0.027
71933634|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.17|STANDARD_ERROR_OF_MEAN|0.08||0.04|TWO_SIDED|95.0|0.01|0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.32|0.01|0.040
71933635|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.64|-0.32||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.32|-0.64|<0.001
71933636|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.58|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.74|-0.42||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.42|-0.74|<0.001
71933637|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.14|STANDARD_ERROR_OF_MEAN|0.08||0.094|TWO_SIDED|95.0|-0.3|0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||0.02|-0.30|0.094
71933638|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.003|TWO_SIDED|95.0|-0.4|-0.08||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.08|-0.40|0.003
71690994|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.55||||0.006|TWO_SIDED|90.0|1.91|7.19|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.19|1.91|0.006
71933639|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.4|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.57|-0.23||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.23|-0.57|<0.001
71933640|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.51|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.68|-0.35||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.35|-0.68|<0.001
71933641|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.032|TWO_SIDED|95.0|-0.35|-0.02||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.02|-0.35|0.032
71933642|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.29|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.46|-0.13||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.13|-0.46|<0.001
71933643|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.54|-0.21||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.21|-0.54|<0.001
71933644|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.52|-0.19||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.19|-0.52|<0.001
71933645|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.21|STANDARD_ERROR_OF_MEAN|0.08||0.012|TWO_SIDED|95.0|-0.38|-0.05||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.05|-0.38|0.012
71690995|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.3||||0.002|TWO_SIDED|90.0|2.66|7.94|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.94|2.66|0.002
71933646|NCT00830063|143388214|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.08||0.021|TWO_SIDED|95.0|-0.36|-0.03||P-value was based on ANCOVA from pairwise comparisons.|ANCOVA|||Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.||-0.03|-0.36|0.021
71933647|NCT00661674|143388258|SUPERIORITY_OR_OTHER|||||||0.0001||||||p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.0001
71933648|NCT00661674|143388259|SUPERIORITY_OR_OTHER|||||||0.2244||||||p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron \& Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."||||0.2244
71933649|NCT01872689|143388260|SUPERIORITY||Median Difference (Final Values)|0.98111|STANDARD_ERROR_OF_MEAN|1.31064||0.4555|TWO_SIDED|95.0|-1.61|3.57|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||3.57|-1.61|0.4555
71933650|NCT01872689|143388260|SUPERIORITY||Mean Difference (Final Values)|0.49998|STANDARD_ERROR_OF_MEAN|0.84946||0.5566|TWO_SIDED|95.0|-1.17|2.17|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.17|-1.17|0.5566
71933651|NCT01872689|143388261|SUPERIORITY||Median Difference (Final Values)|21.93023|STANDARD_ERROR_OF_MEAN|21.62248||0.3129|TWO_SIDED|95.0|-20.97|64.83|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||64.83|-20.97|0.3129
71933652|NCT01872689|143388261|SUPERIORITY||Mean Difference (Final Values)|-21.4127|STANDARD_ERROR_OF_MEAN|16.8016||0.2036|TWO_SIDED|95.0|-54.5|11.67|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||11.67|-54.50|0.2036
71933653|NCT01872689|143388263|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.4299|TWO_SIDED|95.0|0.44|1.41|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.41|0.44|0.4299
71933654|NCT01872689|143388263|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.3751|TWO_SIDED|95.0|0.56|1.24|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.24|0.56|0.3751
71933655|NCT01872689|143388264|SUPERIORITY||Median Difference (Final Values)|0.54171|STANDARD_ERROR_OF_MEAN|1.05201||0.6075|TWO_SIDED|95.0|-1.54|2.62|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.62|-1.54|0.6075
71933656|NCT01872689|143388264|SUPERIORITY||Mean Difference (Final Values)|0.18203|STANDARD_ERROR_OF_MEAN|0.65206||0.7803|TWO_SIDED|95.0|-1.1|1.47|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||1.47|-1.10|0.7803
71933657|NCT01872689|143388266|SUPERIORITY||Hazard Ratio (HR)|0.65||||0.0972|TWO_SIDED|95.0|0.39|1.09|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.09|0.39|0.0972
71933658|NCT01872689|143388266|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.9344|TWO_SIDED|95.0|0.72|1.42|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.42|0.72|0.9344
71933659|NCT01872689|143388267|SUPERIORITY||Median Difference (Final Values)|28.12302|STANDARD_ERROR_OF_MEAN|49.47253||0.5707|TWO_SIDED|95.0|-69.8|126.04|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||126.04|-69.80|0.5707
71690996|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.51|||<|0.001|TWO_SIDED|90.0|4.87|10.16|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||10.16|4.87|<0.001
71933660|NCT01872689|143388267|SUPERIORITY||Mean Difference (Final Values)|21.72972|STANDARD_ERROR_OF_MEAN|31.68767||0.4934|TWO_SIDED|95.0|-40.65|84.11|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||84.11|-40.65|0.4934
71933661|NCT01872689|143388268|SUPERIORITY||Median Difference (Final Values)|-2.10204|STANDARD_ERROR_OF_MEAN|2.41325||0.3854|TWO_SIDED|95.0|-6.88|2.68|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.68|-6.88|0.3854
71933662|NCT01872689|143388268|SUPERIORITY||Mean Difference (Final Values)|-0.16313|STANDARD_ERROR_OF_MEAN|1.37698||0.9057|TWO_SIDED|95.0|-2.87|2.55|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (\<50%, 50 to 75%, \>75%) and participant by assessment time as random effects with unstructured covariance.||2.55|-2.87|0.9057
71933663|NCT01872689|143388270|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.4433|TWO_SIDED|95.0|0.54|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.54|0.4433
71933664|NCT01872689|143388272|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.9366|TWO_SIDED|95.0|0.21|5.3|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||5.30|0.21|0.9366
71933665|NCT01872689|143388272|SUPERIORITY||Hazard Ratio (HR)|0.45||||0.1346|TWO_SIDED|95.0|0.16|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.31|0.16|0.1346
71933666|NCT01872689|143388274|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6815|TWO_SIDED|95.0|0.52|1.54|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.54|0.52|0.6815
71933667|NCT01872689|143388276|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.5685|TWO_SIDED|95.0|0.23|2.26|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||2.26|0.23|0.5685
71933668|NCT01872689|143388276|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.1976|TWO_SIDED|95.0|0.37|1.23|||Log Rank|||Stratified Analysis: stratified by baseline FVC (\<50%, 50 to 75%, \>75%)||1.23|0.37|0.1976
71933669|NCT03944707|143388378|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_DEVIATION|0.0698||0.6643|TWO_SIDED|80.0|-0.06|0.119||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.119|-0.060|0.6643
71933670|NCT03944707|143388382|SUPERIORITY||Median Difference (Net)|-0.09|STANDARD_DEVIATION|0.21||0.6609|TWO_SIDED|80.0|-0.35|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.18|-0.35|0.6609
71933671|NCT03944707|143388383|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_DEVIATION|7.13||0.5107|TWO_SIDED|80.0|-9.0|9.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean morning PEF||9.1|-9.0|0.5107
71933672|NCT03944707|143388383|SUPERIORITY||Mean Difference (Net)|-3.4|STANDARD_DEVIATION|9.15||0.3611|TWO_SIDED|80.0|-15.2|8.1||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in mean evening PEF||8.1|-15.2|0.3611
71933673|NCT03944707|143388384|SUPERIORITY||Mean Difference (Net)|-0.133|STANDARD_DEVIATION|0.1588||0.8022|TWO_SIDED|80.0|-0.336|0.071||Probability LOU064 better than placebo|Bayesian model||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|||0.071|-0.336|0.8022
71933674|NCT03944707|143388385|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_DEVIATION|0.1573||0.6312|TWO_SIDED|80.0|-0.251|0.149||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in daytime asthma symptom score||0.149|-0.251|0.6312
71933675|NCT03944707|143388385|SUPERIORITY||Mean Difference (Net)|0.075|STANDARD_DEVIATION|0.0819||0.1752|TWO_SIDED|80.0|-0.028|0.18||Probability LOU064 better than placebo|Bayesian model for repeated measures||Posterior mean difference (LOU064 - placebo) and 80% credible interval are presented.|Change from baseline in nighttime asthma symptom score||0.180|-0.028|0.1752
71933676|NCT01946282|143388417|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.59|||||||Chi-squared|||||||0.59
71933677|NCT01946282|143388417|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.75|||||||Chi-squared|||||||.75
71933678|NCT01946282|143388417|EQUIVALENCE|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.08|||||||Chi-squared|||||||.080
71690997|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|9.14|||<|0.001|TWO_SIDED|90.0|6.57|11.71|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||11.71|6.57|<0.001
71690998|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.69||||0.002|TWO_SIDED|90.0|2.94|8.44|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.44|2.94|0.002
71690999|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.89|||<|0.001|TWO_SIDED|90.0|4.16|9.62|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.62|4.16|<0.001
71691000|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.269|TWO_SIDED|90.0|-0.91|4.58|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.58|-0.91|0.269
71691001|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.49||||0.009|TWO_SIDED|90.0|1.75|7.24|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.24|1.75|0.009
71691002|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.83|||<|0.001|TWO_SIDED|90.0|4.08|9.57|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.57|4.08|<0.001
71691003|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.18|||<|0.001|TWO_SIDED|90.0|3.52|8.84|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.84|3.52|<0.001
71691004|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.52||||0.002|TWO_SIDED|90.0|2.71|8.33|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.33|2.71|0.002
71691005|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.76|||<|0.001|TWO_SIDED|90.0|4.01|9.5|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.50|4.01|<0.001
71691006|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.36||||0.024|TWO_SIDED|90.0|0.95|5.76|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||5.76|0.95|0.024
71933679|NCT01946282|143388418|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.07|||||||Chi-squared|||||||0.070
71933680|NCT01946282|143388418|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.8|||||||Chi-squared|||||||0.80
71933681|NCT01946282|143388418|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.6|||||||Chi-squared|||||||0.60
71691007|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.24|||<|0.001|TWO_SIDED|90.0|2.82|7.66|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.66|2.82|<0.001
71691008|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.64|||<|0.001|TWO_SIDED|90.0|4.23|9.06|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.06|4.23|<0.001
71691009|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.22|||<|0.001|TWO_SIDED|90.0|2.87|7.58|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.58|2.87|<0.001
71691010|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.88||||0.012|TWO_SIDED|90.0|1.39|6.37|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.37|1.39|0.012
71691011|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.98|||<|0.001|TWO_SIDED|90.0|4.48|9.48|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.48|4.48|<0.001
71691012|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.41||||0.003|TWO_SIDED|90.0|2.11|6.72|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.72|2.11|0.003
71691013|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.02|||<|0.001|TWO_SIDED|90.0|2.72|7.33|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.33|2.72|<0.001
71691014|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.58|||<|0.001|TWO_SIDED|90.0|4.27|8.88|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.88|4.27|<0.001
71691015|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.54|||<|0.001|TWO_SIDED|90.0|3.31|7.78|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||7.78|3.31|<0.001
71691016|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.44||||0.003|TWO_SIDED|90.0|2.06|6.82|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.82|2.06|0.003
71691017|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|7.08|||<|0.001|TWO_SIDED|90.0|4.7|9.47|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||9.47|4.70|<0.001
71691018|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.41||||0.103|TWO_SIDED|90.0|-0.02|4.84|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||4.84|-0.02|0.103
71691019|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.75||||0.013|TWO_SIDED|90.0|1.32|6.18|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||6.18|1.32|0.013
71691020|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.96|||<|0.001|TWO_SIDED|90.0|3.53|8.39|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.39|3.53|<0.001
71691021|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.87|||<|0.001|TWO_SIDED|90.0|3.5|8.23|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.23|3.50|<0.001
71691022|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.65|||<|0.001|TWO_SIDED|90.0|3.18|8.11|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.11|3.18|<0.001
71933682|NCT01946282|143388418|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.31|||||||Chi-squared|||||||0.31
71933683|NCT01946282|143388418|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.82|||||||Chi-squared|||||||0.82
71933684|NCT01946282|143388418|EQUIVALENCE|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.||||||0.033|||||||Chi-squared|||||||0.033
71691023|NCT00572455|142898104|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.97|||<|0.001|TWO_SIDED|90.0|3.46|8.48|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.||8.48|3.46|<0.001
71691024|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.72||||0.377|TWO_SIDED|90.0|-0.63|2.08|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.08|-0.63|0.377
71691025|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.68||||0.039|TWO_SIDED|90.0|-3.01|-0.35|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||-0.35|-3.01|0.039
71691026|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34||||0.668|TWO_SIDED|90.0|-1.67|0.98|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.98|-1.67|0.668
71691027|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.121|TWO_SIDED|90.0|-0.07|2.59|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|-0.07|0.121
71933685|NCT01946282|143388418|EQUIVALENCE|We estimated needing 545 observations per incentive group to achieve power necessary to detect at least a 10% absolute difference in FIT return rate between patients who received the $5 incentive versus patients who received the $10 incentive, with assumed rates of 45% in the $5 incentive group and 53% in the $10 incentive group, a=0.05, and power=90%.||||||0.033|||||||Chi-squared|||||||0.033
71933686|NCT01946282|143388418|EQUIVALENCE||||||>|0.99|||||||Chi-squared|||||||>0.99
71933687|NCT01946282|143388418|EQUIVALENCE|||||||0.184|||||||Chi-squared|||||||0.184
71933688|NCT01507831|143388420|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.9|||<|0.0001|TWO_SIDED|95.0|-64.3|-59.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-59.4|-64.3|<0.0001
71691028|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.67||||0.039|TWO_SIDED|90.0|0.34|2.99|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.99|0.34|0.039
71691029|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99||||0.22|TWO_SIDED|90.0|-0.34|2.31|||ANCOVA|||Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.31|-0.34|0.220
71691030|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.3||||0.098|TWO_SIDED|90.0|0.01|2.59|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.59|0.01|0.098
71933689|NCT01507831|143388421|SUPERIORITY_OR_OTHER||LS Mean Difference|-63.5|||<|0.0001|TWO_SIDED|95.0|-65.9|-61.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-61.2|-65.9|<0.0001
71933690|NCT01507831|143388422|SUPERIORITY_OR_OTHER||LS Mean Difference|-64.8|||<|0.0001|TWO_SIDED|95.0|-67.2|-62.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-62.4|-67.2|<0.0001
71933691|NCT01507831|143388423|SUPERIORITY_OR_OTHER||LS Mean Difference|-65.5|||<|0.0001|TWO_SIDED|95.0|-67.9|-63.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-63.2|-67.9|<0.0001
71933692|NCT01507831|143388424|SUPERIORITY_OR_OTHER||LS Mean Difference|-61.3|||<|0.0001|TWO_SIDED|95.0|-64.0|-58.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-58.5|-64.0|<0.0001
71933693|NCT01507831|143388425|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.0|||<|0.0001|TWO_SIDED|95.0|-56.3|-51.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.7|-56.3|<0.0001
71933694|NCT01507831|143388426|SUPERIORITY_OR_OTHER||LS Mean Difference|-55.5|||<|0.0001|TWO_SIDED|95.0|-57.7|-53.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.2|-57.7|<0.0001
71933695|NCT01507831|143388427|SUPERIORITY_OR_OTHER||LS Mean Difference|-52.3|||<|0.0001|TWO_SIDED|95.0|-54.4|-50.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-50.2|-54.4|<0.0001
71933696|NCT01507831|143388428|SUPERIORITY_OR_OTHER||LS Mean Difference|-53.7|||<|0.0001|TWO_SIDED|95.0|-55.7|-51.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-51.6|-55.7|<0.0001
71933697|NCT01507831|143388429|SUPERIORITY_OR_OTHER||LS Mean Difference|-37.5|||<|0.0001|TWO_SIDED|95.0|-39.1|-35.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-35.9|-39.1|<0.0001
71933698|NCT01507831|143388430|SUPERIORITY_OR_OTHER||LS Mean Difference|-56.0|||<|0.0001|TWO_SIDED|95.0|-58.3|-53.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-53.7|-58.3|<0.0001
71933699|NCT01507831|143388431|SUPERIORITY_OR_OTHER||LS Mean Difference|-54.6|||<|0.0001|TWO_SIDED|95.0|-56.6|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-52.6|-56.6|<0.0001
71933700|NCT01507831|143388432|SUPERIORITY_OR_OTHER||LS Mean Difference|-39.0|||<|0.0001|TWO_SIDED|95.0|-40.4|-37.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-37.5|-40.4|<0.0001
71933701|NCT01507831|143388433|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|71.5|||<|0.0001|TWO_SIDED|95.0|51.6|99.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||99.1|51.6|<0.0001
71933702|NCT01507831|143388434|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|93.4|||<|0.0001|TWO_SIDED|95.0|66.1|132.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||132.0|66.1|<0.0001
71933703|NCT01507831|143388435|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|74.6|||<|0.0001|TWO_SIDED|95.0|53.3|104.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||104.4|53.3|<0.0001
71933704|NCT01507831|143388436|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|97.3|||<|0.0001|TWO_SIDED|95.0|68.2|138.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||138.9|68.2|<0.0001
71691031|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.519|TWO_SIDED|90.0|-0.77|1.77|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-0.77|0.519
71933705|NCT01507831|143388437|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.6|||<|0.0001|TWO_SIDED|95.0|-28.1|-23.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-23.1|-28.1|<0.0001
71933706|NCT01507831|143388438|SUPERIORITY_OR_OTHER||LS Mean Difference|4.6|||<|0.0001|TWO_SIDED|95.0|3.3|5.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.9|3.3|<0.0001
71933707|NCT01507831|143388439|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.3|||<|0.0001|TWO_SIDED|95.0|-20.1|-14.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-14.6|-20.1|<0.0001
71933708|NCT01507831|143388440|SUPERIORITY_OR_OTHER||LS Mean Difference|2.9|||<|0.0001|TWO_SIDED|95.0|1.6|4.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.2|1.6|<0.0001
71933709|NCT01507831|143388441|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-25.1|||<|0.0001|TWO_SIDED|95.0|-27.4|-22.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.7|-27.4|<0.0001
71933710|NCT01507831|143388442|SUPERIORITY_OR_OTHER||LS Mean Difference|5.6|||<|0.0001|TWO_SIDED|95.0|4.3|6.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||6.8|4.3|<0.0001
71933711|NCT01507831|143388443|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-17.9|||<|0.0001|TWO_SIDED|95.0|-20.5|-15.3||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.3|-20.5|<0.0001
71933712|NCT01507831|143388444|SUPERIORITY_OR_OTHER||LS Mean Difference|4.0|||<|0.0001|TWO_SIDED|95.0|2.8|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||5.2|2.8|<0.0001
71933713|NCT02766400|143388467|SUPERIORITY_OR_OTHER_LEGACY||Cohen's d effect size at 12 months|0.53|||<|0.001|TWO_SIDED|95.0|-0.12|1.19||a priori threshold was set at p\<0.05|Linear mixed models|F(4,150)=5.11|Effect size was calculated using mean change scores (baseline to month 12) and standard error of change (baseline to month 12) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.||1.19|-0.12|<0.001
71933714|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.04819|STANDARD_ERROR_OF_MEAN|0.02482||0.0535|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total POQ Score as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0535
71933715|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00163|STANDARD_ERROR_OF_MEAN|0.001826||0.3729|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Rating as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.3729
71933716|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00593|STANDARD_ERROR_OF_MEAN|0.007228||0.4124|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mobility as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.4124
71933717|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00432|STANDARD_ERROR_OF_MEAN|0.009334||0.6442|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities of Daily Living as outcome variable. Linear mixed models were constructed with fixed effects terms for treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test if the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.6442
71933718|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00898|STANDARD_ERROR_OF_MEAN|0.006436||0.1641|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Vitality as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1641
71933719|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01952|STANDARD_ERROR_OF_MEAN|0.009846||0.0487|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Neg. Affect as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.0487
71933720|NCT03593772|143388468|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0066|STANDARD_ERROR_OF_MEAN|0.004644||0.1554|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Fear as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.05. Borderline statistical significance was considered to be \<0.1.||||0.1554
71933721|NCT03593772|143388469|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00113|STANDARD_ERROR_OF_MEAN|0.000863||0.1924|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1924
71933722|NCT03593772|143388469|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0019|STANDARD_ERROR_OF_MEAN|0.001152||0.1002|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stress as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1002
71933723|NCT03593772|143388469|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000343|STANDARD_ERROR_OF_MEAN|0.000996||0.7311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Tension as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7311
71933724|NCT03593772|143388470|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00241|STANDARD_ERROR_OF_MEAN|0.001716||0.1622|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain as the outcome variable. Linear mixed models were constructed with fixed effects terms for the treatment group (MR vs. WC), time (continuous), and a treatment group x time interaction term to test whether the rate of change in the instrument score differed by treatment group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1622
71933725|NCT03593772|143388470|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00235|STANDARD_ERROR_OF_MEAN|0.002052||0.254|TWO_SIDED||||||Mixed Models Analysis|||Analysis performed on Pain Interference with Activity as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2540
71933726|NCT03593772|143388470|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00612|STANDARD_ERROR_OF_MEAN|0.002297||0.0082|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Sleep as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0082
71933727|NCT03593772|143388470|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00636|STANDARD_ERROR_OF_MEAN|0.002378||0.0079|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Mood as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0079
71933728|NCT03593772|143388470|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00334|STANDARD_ERROR_OF_MEAN|0.002367||0.1588|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Pain Interference with Stress as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1588
71933729|NCT03593772|143388471|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00974|STANDARD_ERROR_OF_MEAN|0.01379||0.4808|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PCL-5 Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4808
71933730|NCT03593772|143388472|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00033|STANDARD_ERROR_OF_MEAN|0.00856||0.9692|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Physical Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9692
71933731|NCT03593772|143388472|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01738|STANDARD_ERROR_OF_MEAN|0.007848||0.0277|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Mental Health Domain Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0277
71933732|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00188|STANDARD_ERROR_OF_MEAN|0.003253||0.5642|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total PSQI Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5642
71933733|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00092|STANDARD_ERROR_OF_MEAN|0.00079||0.2438|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Subjective Sleep Quality Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2438
71933734|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000304|STANDARD_ERROR_OF_MEAN|0.000885||0.7317|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep latency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7317
71933735|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00062|STANDARD_ERROR_OF_MEAN|0.001327||0.6393|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep duration Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6393
71933736|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00112|STANDARD_ERROR_OF_MEAN|0.000873||0.1995|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep efficiency Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1995
71933737|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00072|STANDARD_ERROR_OF_MEAN|0.000675||0.2886|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Sleep disturbance Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2886
71933738|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002048|STANDARD_ERROR_OF_MEAN|0.001356||0.1323|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Use of sleep medication Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1323
71933739|NCT03593772|143388473|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000209|STANDARD_ERROR_OF_MEAN|0.000793||0.7923|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on PSQI Daytime dysfunction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7923
71933740|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00046|STANDARD_ERROR_OF_MEAN|0.001074||0.6679|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6679
71933741|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001083|STANDARD_ERROR_OF_MEAN|0.000769||0.1607|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on COS Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1607
71933742|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000984|STANDARD_ERROR_OF_MEAN|0.00064||0.126|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1260
71933743|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000909|STANDARD_ERROR_OF_MEAN|0.000933||0.3311|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3311
71933744|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001041|STANDARD_ERROR_OF_MEAN|0.000887||0.2416|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2416
71933745|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00087|STANDARD_ERROR_OF_MEAN|0.001016||0.3903|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3903
71933746|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001186|STANDARD_ERROR_OF_MEAN|0.00095||0.2131|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2131
71933747|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001485|STANDARD_ERROR_OF_MEAN|0.000933||0.113|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1130
71933748|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001983|STANDARD_ERROR_OF_MEAN|0.000939||0.0358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0358
71933749|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00019|STANDARD_ERROR_OF_MEAN|0.000495||0.7027|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS- Total Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7027
71933750|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000761|STANDARD_ERROR_OF_MEAN|0.00073||0.2979|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Kindness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.2979
71933751|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00063|STANDARD_ERROR_OF_MEAN|0.000798||0.4278|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Self-Judgment Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4278
71691032|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.724|TWO_SIDED|90.0|-1.0|1.55|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.55|-1.00|0.724
71933752|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.0000074|STANDARD_ERROR_OF_MEAN|0.000877||0.9933|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Common Humanity Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9933
71933753|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00115|STANDARD_ERROR_OF_MEAN|0.000816||0.1589|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Isolation Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1589
71933754|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000109|STANDARD_ERROR_OF_MEAN|0.000767||0.8875|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Mindfulness Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8875
71933755|NCT03593772|143388474|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00032|STANDARD_ERROR_OF_MEAN|0.00078||0.6859|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on CSS Over-identification Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6859
71933756|NCT03593772|143388475|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.01408|STANDARD_ERROR_OF_MEAN|0.01085||0.1959|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on BDI total score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1959
71933757|NCT03593772|143388476|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00788|STANDARD_ERROR_OF_MEAN|0.005845||0.1792|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Perceived Stress Scale Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1792
71933758|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00132|STANDARD_ERROR_OF_MEAN|0.01039||0.8991|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.8991
71933759|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002105|STANDARD_ERROR_OF_MEAN|0.002349||0.3711|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.3711
71933760|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001864|STANDARD_ERROR_OF_MEAN|0.002348||0.428|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4280
71933761|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00007|STANDARD_ERROR_OF_MEAN|0.003205||0.9831|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Affection Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9831
71933762|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003052|STANDARD_ERROR_OF_MEAN|0.006364||0.632|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.6320
71933763|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00007|STANDARD_ERROR_OF_MEAN|0.002259||0.9755|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9755
71933764|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00056|STANDARD_ERROR_OF_MEAN|0.001818||0.7584|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7584
71933765|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.000297|STANDARD_ERROR_OF_MEAN|0.003444||0.9313|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9313
71933766|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00129|STANDARD_ERROR_OF_MEAN|0.002097||0.5401|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.5401
71933767|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.00018|STANDARD_ERROR_OF_MEAN|0.002471||0.9421|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.9421
71933768|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00151|STANDARD_ERROR_OF_MEAN|0.003983||0.7042|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7042
71933769|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.02128|STANDARD_ERROR_OF_MEAN|0.008331||0.0114|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total RDAS Score as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0114
71933770|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002587|STANDARD_ERROR_OF_MEAN|0.001727||0.1358|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Decision Making Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1358
71691033|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.46||||0.059|TWO_SIDED|90.0|0.19|2.74|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.74|0.19|0.059
71691034|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.71|||<|0.001|TWO_SIDED|90.0|1.43|3.98|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.98|1.43|<0.001
71691035|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.008|TWO_SIDED|90.0|0.82|3.37|||ANCOVA|||Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.37|0.82|0.008
71691036|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.32||||0.068|TWO_SIDED|90.0|0.13|2.51|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.51|0.13|0.068
71933771|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.001402|STANDARD_ERROR_OF_MEAN|0.001796||0.4354|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Values Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.4354
71933772|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.005759|STANDARD_ERROR_OF_MEAN|0.002113||0.007|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on AffectionSubdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0070
71933773|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.01037|STANDARD_ERROR_OF_MEAN|0.004485||0.0217|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Consensus Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0217
71691037|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01||||0.994|TWO_SIDED|90.0|-1.16|1.18|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.18|-1.16|0.994
71691038|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.494|TWO_SIDED|90.0|-0.7|1.69|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-0.70|0.494
71691039|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.39||||0.063|TWO_SIDED|90.0|0.16|2.62|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.62|0.16|0.063
71691040|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.15||||0.004|TWO_SIDED|90.0|0.95|3.34|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.34|0.95|0.004
71691041|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.17||||0.004|TWO_SIDED|90.0|0.97|3.38|||ANCOVA|||Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.97|0.004
71691042|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.55||||0.038|TWO_SIDED|90.0|0.32|2.77|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.32|0.038
71691043|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.48||||0.512|TWO_SIDED|90.0|-0.72|1.68|||ANCOVA|||Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.68|-0.72|0.512
71691044|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.66||||0.373|TWO_SIDED|90.0|-0.56|1.89|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.89|-0.56|0.373
71691045|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.088|TWO_SIDED|90.0|0.05|2.56|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.56|0.05|0.088
71691046|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.21||||0.004|TWO_SIDED|90.0|0.98|3.44|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.98|0.004
71691047|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.33||||0.003|TWO_SIDED|90.0|1.09|3.57|||ANCOVA|||Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.57|1.09|0.003
71933774|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|-0.00039|STANDARD_ERROR_OF_MEAN|0.001461||0.7881|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Stability Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.7881
71933775|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004717|STANDARD_ERROR_OF_MEAN|0.00141||0.001|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Conflict Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0010
71933776|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.004393|STANDARD_ERROR_OF_MEAN|0.002415||0.0693|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Satisfaction Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.0693
71691048|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|1.87||||0.01|TWO_SIDED|90.0|0.69|3.04|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.04|0.69|0.010
71691049|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.89||||0.205|TWO_SIDED|90.0|-0.27|2.05|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.05|-0.27|0.205
71691050|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.44||||0.045|TWO_SIDED|90.0|0.26|2.63|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.63|0.26|0.045
71691051|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.09||||0.005|TWO_SIDED|90.0|0.88|3.31|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.31|0.88|0.005
71691052|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.51|||<|0.001|TWO_SIDED|90.0|1.33|3.7|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.70|1.33|<0.001
71691053|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.002|TWO_SIDED|90.0|1.1|3.48|||ANCOVA|||Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.48|1.10|0.002
71691054|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.757|TWO_SIDED|90.0|-1.15|1.69|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.69|-1.15|0.757
71691055|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.13||||0.878|TWO_SIDED|90.0|-1.54|1.27|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.27|-1.54|0.878
71691056|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.24||||0.78|TWO_SIDED|90.0|-1.64|1.17|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.17|-1.64|0.780
71933777|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.002959|STANDARD_ERROR_OF_MEAN|0.001887||0.1184|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Activities Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1184
71933778|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.003436|STANDARD_ERROR_OF_MEAN|0.002262||0.1301|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Discussion Subdomain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1301
71933779|NCT03593772|143388477|OTHER|Treatment is compared against a Waitlist Control Group.|Slope|0.006022|STANDARD_ERROR_OF_MEAN|0.003697||0.1049|TWO_SIDED|||||p value provided is for interaction term between Time (continuous) \* Treatment group (MR vs. WC)|Mixed Models Analysis|||Analysis performed on Total Cohesion Domain as outcome variable. Linear mixed models were constructed with fixed effects terms for the Tx group (MR vs. WC), time (continuous), and a Tx group x time interaction term to test whether the rate of change in the instrument score differed by Tx group. Random effects for the intercept and time were also included. The α p-value for statistical significance was set at 0.01. Borderline statistical significance was considered to be \<0.1.||||0.1049
71933780|NCT01989195|143388484|SUPERIORITY_OR_OTHER||||||<|0.05|||||||t-test, 2 sided|||||||<.05
71933781|NCT02731833|143388502|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-0.4|||<|0.0001|TWO_SIDED|95.0|-0.505|-0.3|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as factor and baseline Schiff sensitivity score as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|Statistical analyses was conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.||-0.300|-0.505|<0.0001
71933782|NCT01529749|143388591|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933783|NCT01529749|143388592|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933784|NCT01529749|143388593|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933785|NCT01529749|143388594|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933786|NCT01529749|143388595|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933787|NCT01529749|143388596|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933788|NCT01529749|143388597|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933789|NCT01529749|143388598|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933790|NCT01529749|143388599|SUPERIORITY|||||||0.01|||||||Kruskal-Wallis|||||||0.01
71933791|NCT01529749|143388600|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933792|NCT01529749|143388601|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933793|NCT01529749|143388602|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933794|NCT01529749|143388603|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933795|NCT01529749|143388604|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933796|NCT01529749|143388605|SUPERIORITY|||||||1|||||||Chi-squared, Corrected|||||||1
71933797|NCT01529749|143388606|SUPERIORITY|||||||0.49|||||||Chi-squared, Corrected|||||||0.49
71933798|NCT01529749|143388607|SUPERIORITY|||||||0.02|||||||Kruskal-Wallis|||||||0.02
71933799|NCT00265083|143388615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide \>=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP\<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP\<1.5mg/dL and 32.5-45% in pts with screening CRP\>=1.5mg/dL, between Groups I vs II or III.||||<0.001
71933800|NCT00265083|143388615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
71933801|NCT00265083|143388615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||||||<0.001
71933802|NCT00265083|143388616|SUPERIORITY_OR_OTHER||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.||||<0.001
71933803|NCT00265083|143388616|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group II and Group I.||||<0.001
71933804|NCT00265083|143388616|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (\<=1.5mg/dL, \>1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group III and Group I.||||<0.001
71933805|NCT00265083|143388617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value \<0.05), and at least one of the pair-wise comparisons is also significant (p-value \<0.05).|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.||||<0.001
71933806|NCT00265083|143388617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group II and Group I.||||<0.001
71933807|NCT00265083|143388617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group III and Group I.||||<0.001
71933808|NCT00265083|143388618|SUPERIORITY_OR_OTHER|||||||0.288||95.0||||The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.||||0.288
71933809|NCT00265083|143388618|SUPERIORITY_OR_OTHER|||||||0.444||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group II and Group I.||||0.444
71933810|NCT00265083|143388618|SUPERIORITY_OR_OTHER|||||||0.247||95.0|||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group III and Group I.||||0.247
71933811|NCT01314703|143388663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.85|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.66|3.02|||ANOVA||ChloraPrep 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.02|2.66|
71933812|NCT01314703|143388663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.038|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.74|4.33|||ANOVA||ChloraPrep 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||4.33|3.74|
71933813|NCT01314703|143388663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.53|STANDARD_ERROR_OF_MEAN|0.089|||TWO_SIDED|95.0|2.36|2.7|||ANOVA||70%Isopropyl Alcohol 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||2.70|2.36|
71933814|NCT01314703|143388663|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.53|STANDARD_ERROR_OF_MEAN|0.149|||TWO_SIDED|95.0|3.24|3.82|||ANOVA||70% Isopropyl Alcohol 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).||3.82|3.24|
71933815|NCT01965535|143388750|SUPERIORITY_OR_OTHER||difference in proportions|1.4|||||TWO_SIDED|95.0|-5.9|8.6|||||The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.|A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.||8.6|-5.9|
71933816|NCT01493531|143388762|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.32|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.23|0.41|||Cochran-Mantel-Haenszel|||||0.41|0.23|<0.0001
71691057|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.36||||0.67|TWO_SIDED|90.0|-1.04|1.77|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.77|-1.04|0.670
71933817|NCT01493531|143388762|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.43|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|0.34|0.52|||Cochran-Mantel-Haenszel|||||0.52|0.34|<0.0001
71933818|NCT01493531|143388763|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.88||||0.5716|TWO_SIDED|95.0|0.57|1.37|||Negative Binomial Regression|||||1.37|0.57|0.5716
71933819|NCT01493531|143388763|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.7454|TWO_SIDED|95.0|0.6|1.45|||Negative Binomial Regression|||||1.45|0.60|0.7454
71933820|NCT01493531|143388764|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.02||||0.8466|TWO_SIDED|95.0|-0.24|0.2|||Cochran-Mantel-Haenszel|||||0.2|-0.24|0.8466
71933821|NCT01493531|143388764|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.06||||0.6301|TWO_SIDED|95.0|-0.29|0.17|||Cochran-Mantel-Haenszel|||||0.17|-0.29|0.6301
71933822|NCT01205529|143388774|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED||||||Regression, Logistic||0 participants with rare SCN5A non-synonymous variants met the primary outcome for ST-segment elevation.||Given the very small number of outcomes (N=4) and the small number of participants with the primary determinant (N=2), a Fisher's Exact Test is the appropriate test and it yields a P-value=1.000.|||1.0
71933823|NCT02059187|143388787|NON_INFERIORITY_OR_EQUIVALENCE|MK-1293 was to be considered non-inferior to Lantus in type 2 diabetes mellitus (T2DM) if the upper bound of the two-sided 95% confidence interval (CI) for the between-treatment difference (MK-1293 minus Lantus) in least-squares (LS) means was below 0.4% based on a cLDA model.|Difference in least squares means|0.03|||||TWO_SIDED|95.0|-0.12|0.18||||||||0.18|-0.12|
71933824|NCT02059187|143388788|SUPERIORITY_OR_OTHER||Difference in percentage|5.7|||||TWO_SIDED|95.0|-2.3|13.7||||||||13.7|-2.3|
71933825|NCT02059187|143388790|SUPERIORITY_OR_OTHER||Difference in percentage|0.0|||||TWO_SIDED|95.0|-8.5|8.5||||||||8.5|-8.5|
71933826|NCT02059187|143388791|SUPERIORITY_OR_OTHER||Difference in percent|6.8|||||TWO_SIDED|95.0|-0.6|14.2||||||||14.2|-0.6|
71933827|NCT02059187|143388792|SUPERIORITY_OR_OTHER||Difference in LS means|1.4|||||TWO_SIDED|95.0|-2.2|4.9||||||||4.9|-2.2|
71933828|NCT02059187|143388793|SUPERIORITY_OR_OTHER||Dofference in LS means|0.01|||||TWO_SIDED|95.0|-0.02|0.05||||||||0.05|-0.02|
71933829|NCT02059187|143388794|SUPERIORITY_OR_OTHER||Difference in LS means|3.5|||||TWO_SIDED|95.0|-3.7|10.7||||||||10.7|-3.7|
71933830|NCT02059187|143388795|SUPERIORITY_OR_OTHER||Difference in LS Means|-3.4|||||TWO_SIDED|95.0|-11.3|4.4||||||||4.4|-11.3|
71933831|NCT02059187|143388796|SUPERIORITY_OR_OTHER||Adjusted difference in percent|2.8|||||TWO_SIDED|95.0|-6.1|11.6|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||11.6|-6.1|
71933832|NCT02059187|143388797|SUPERIORITY_OR_OTHER||Adjusted difference in percent|-0.9|||||TWO_SIDED|95.0|-8.3|6.5|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.|||6.5|-8.3|
71933833|NCT03070431|143388798|SUPERIORITY|It was assumed that radiotherapy with 5x4 Gy results in 6-month LPFS of 67% and an increase by 20% is clinically relevant when using 5x5 Gy. For comparison of 5x5 Gy and a historical control (5x4 Gy), it was assumed that it can be performed with a simple Pearson-Chi-Square test (2-sided significance level of 5%, power of 79%) if 40 patients treated with 5x5 Gy and 400 patients of the control group qualified for Propensity-Score adjusted comparison, assuming 6-month LPFS rates of 87% and 67%.|Risk Difference (RD)|20.0|||<|0.05|TWO_SIDED||||||Cochran-Mantel-Haenszel|||historical control group treated with 5 x 4 Gy|"In a prospective study, 6-month LPFS rates were 86% after longer-course (mainly 3Gyx10) and 67% after short-course radiotherapy (mainly 4Gyx5) \[Rades D, et al., Int J Radiat Oncol Biol Phys 2009;73:228-34.\]. For sample size calculations, it was assumed that conventional radiotherapy with 4Gyx5 results in 6-month LPFS of 67% and that an increase by 20% is clinically relevant and realistic with 5Gyx5. A sample size of 40 eligible patients was required for the phase 2 trial assuming that that 6-month LPFS would be 87% and estimated with a precision of +/-20% expressed as the half length of the associated two-sided confidence interval (95%), and power of \>=80%.~For comparison of phase 2 cohort and historical control group, it was assumed that this could be performed with a simple Pearson-Chi-Square test using a two-sided significance level of 5% (10%) and a power of 79% (86%) if 40 patients received 5Gyx5 and N=400 of the control group qualified for Propensity-Score adjusted comparison."|||<0.05
71933834|NCT01889862|143388808|SUPERIORITY||Mean Difference (Net)|-973.02|||<|0.0001|TWO_SIDED|95.0|-1204.19|-741.85||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 20mg/day compared with those who self administer matching placebo.||-741.85|-1204.19|<0.0001
71933835|NCT01889862|143388808|SUPERIORITY||Mean Difference (Net)|-588.5|||<|0.0001|TWO_SIDED|95.0|-830.07|-346.94||Based on Mixed-Effect Model Repeated Measure (MMRM) model with change from baseline as the response variable, and treatment, visit and treatment by visit interaction and baseline blood phe concentration as factors.|ANCOVA|||Change in blood Phe concentration during Part 2 in subjects previously exposed to BMN165 who self administer BMN165 40mg/day compared with those who self administer matching placebo.||-346.94|-830.07|<0.0001
71933836|NCT00845026|143388814|SUPERIORITY_OR_OTHER_LEGACY|||||||0.184||95.0||||No adjustments were made for multiplicity. All treatment comparisons were evaluated based on a two-sided significance level of 0.05.|Log Rank|||||||0.184
71933837|NCT01455545|143388869|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.999||||0.967|TWO_SIDED|95.0|0.962|1.037|||Regression, Logistic|||Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.||1.037|0.962|0.967
71933838|NCT01455545|143388870|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.001||||0.861|TWO_SIDED|95.0|0.985|1.018|||Regression, Logistic|||||1.018|0.985|0.861
71933839|NCT01455545|143388871|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.625||||0.252|TWO_SIDED|95.0|0.706|3.739|||Chi-squared|||Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square||3.739|0.706|0.252
71933840|NCT01455545|143388872|SUPERIORITY_OR_OTHER|||||||0.217||95.0|||||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Chi - square||||0.217
71933841|NCT01455545|143388873|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.643|TWO_SIDED|95.0|0.376|1.829|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square||1.829|0.376|0.643
71933842|NCT01455545|143388874|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.556||||0.155|TWO_SIDED|95.0|0.247|1.253|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.253|0.247|0.155
71933843|NCT01455545|143388875|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.19||||0.107|TWO_SIDED|95.0|0.02|1.763|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||1.763|0.020|0.107
71933844|NCT01455545|143388876|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.849||||0.196|TWO_SIDED|95.0|1.541|2.219|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||2.219|1.541|0.196
71933845|NCT01455545|143388877|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.135||||0.15|TWO_SIDED|95.0|0.618|15.91|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.||15.91|0.618|0.150
71933846|NCT01455545|143388878|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.096||||0.822|TWO_SIDED|95.0|0.492|2.441|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.||2.441|0.492|0.822
71933847|NCT01455545|143388879|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|||||||0.003
71933848|NCT01455545|143388879|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.038||||0.005|TWO_SIDED|95.0|1.012|1.065|||Regression, Logistic|||||1.065|1.012|0.005
71933849|NCT01455545|143388880|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35||||0.013|TWO_SIDED|95.0|0.153|0.799|||Regression, Logistic|||Ho = no differences between both groups H1= there are differences between both groups.||0.799|0.153|0.013
71933850|NCT00106028|143388881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.438||||0.0625|TWO_SIDED|95.0|-0.235|9.111|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.111|-0.235|0.0625
71933851|NCT00106028|143388882|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.537||||0.6103|TWO_SIDED|95.0|-4.424|7.497|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.497|-4.424|0.6103
71933852|NCT00106028|143388883|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.554||||0.0808||95.0|-0.193|3.301|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.301|-0.193|0.0808
71933853|NCT00106028|143388884|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.498||||0.6466|TWO_SIDED|95.0|-1.648|2.644|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.644|-1.648|0.6466
71933854|NCT00106028|143388885|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.465||||0.7391|TWO_SIDED|95.0|-3.224|2.294|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||2.294|-3.224|0.7391
71691058|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.98||||0.021|TWO_SIDED|90.0|0.58|3.38|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.38|0.58|0.021
71933855|NCT00106028|143388886|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.333|||<|0.0001||95.0|5.258|15.408|||ANCOVA|LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||15.408|5.258|<0.0001
71933856|NCT00106028|143388887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.04||||1789|TWO_SIDED|95.0|-2.807|14.887|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||14.887|-2.807|01789
71933857|NCT00106028|143388888|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28||||0.9646|TWO_SIDED|95.0|-12.196|12.755|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||12.755|-12.196|0.9646
71933858|NCT00106028|143388889|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.494||||0.003||95.0|1.912|9.077|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||9.077|1.912|0.0030
71691059|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31||||0.126|TWO_SIDED|90.0|-0.1|2.71|||ANCOVA|||Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.71|-0.10|0.126
71691060|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.215|TWO_SIDED|90.0|-0.32|2.26|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.26|-0.32|0.215
71933859|NCT00106028|143388890|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.473||||0.6106|TWO_SIDED|95.0|-4.245|7.192|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||7.192|-4.245|0.6106
71933860|NCT00106028|143388891|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.315||||0.9372|TWO_SIDED|95.0|-7.598|8.229|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||8.229|-7.598|0.9372
71933861|NCT00106028|143388892|SUPERIORITY_OR_OTHER||Mean Difference (Net)|31.675|||<|0.0001||95.0|21.051|42.3|||ANCOVA|LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||42.300|21.051|<0.0001
71691061|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37||||0.635|TWO_SIDED|90.0|-1.65|0.91|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.91|-1.65|0.635
71691062|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06||||0.934|TWO_SIDED|90.0|-1.35|1.22|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.35|0.934
71691063|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.56||||0.478|TWO_SIDED|90.0|-0.74|1.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.87|-0.74|0.478
71933862|NCT00106028|143388893|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.029||||0.0793|TWO_SIDED|95.0|-1.667|29.726|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||29.726|-1.667|0.0793
71933863|NCT00106028|143388894|SUPERIORITY_OR_OTHER||Mean Difference (Net)|8.567|||<|0.0001||95.0|5.59|11.545|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.545|5.590|<0.0001
71933864|NCT00106028|143388895|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.315||||0.4575|TWO_SIDED|95.0|-10.477|23.107|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.107|-10.477|0.4575
71933865|NCT00106028|143388896|SUPERIORITY_OR_OTHER||Mean Difference (Net)|37.594||||0.0172||95.0|6.801|68.386|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||68.386|6.801|0.0172
71933866|NCT00106028|143388897|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.492||||0.9786|TWO_SIDED|95.0|-36.807|35.824|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||35.824|-36.807|0.9786
71933867|NCT00106028|143388898|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-8.64||||0.5971|TWO_SIDED|95.0|-40.952|23.672|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||23.672|-40.952|0.5971
71933868|NCT00106028|143388899|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.014||||0.4154||95.0|-1.442|3.47|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.470|-1.442|0.4154
71933869|NCT00106028|143388900|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.884||||0.6404|TWO_SIDED|95.0|-2.855|4.623|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.623|-2.855|0.6404
71933870|NCT00106028|143388901|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.66||||0.4978|TWO_SIDED|95.0|-6.499|3.179|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||3.179|-6.499|0.4978
71691064|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.57||||0.002|TWO_SIDED|90.0|1.26|3.87|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.87|1.26|0.002
71933871|NCT00106028|143388902|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.534||||0.027||95.0|0.41|6.658|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.658|0.410|0.0270
71933872|NCT00106028|143388903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.065||||0.5925|TWO_SIDED|95.0|-2.868|4.998|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||4.998|-2.868|0.5925
71933873|NCT00106028|143388904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.193||||0.684|TWO_SIDED|95.0|-4.604|6.991|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.991|-4.604|0.6840
71933874|NCT00106028|143388905|SUPERIORITY_OR_OTHER|||||||0.068||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.0680
71933875|NCT00106028|143388906|SUPERIORITY_OR_OTHER|||||||0.4121||95.0|||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.4121
71933876|NCT00106028|143388907|SUPERIORITY_OR_OTHER|||||||0.3658||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3658
71933877|NCT00106028|143388908|SUPERIORITY_OR_OTHER|||||||0.3408||95.0|||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||||0.3408
71933878|NCT00106028|143388911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253||95.0|0.31|0.922||All Fractures|Cox proportional hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
71933879|NCT00106028|143388911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.534||||0.0253|TWO_SIDED|95.0|0.31|0.922||All Non-Vertebral Fractures|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.922|0.310|0.0253
71933880|NCT00106028|143388911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.487||||0.0501|TWO_SIDED|95.0|0.25|0.95||Long Bone Non-Vertebral Fracture|Cox Proportional Hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.950|0.250|0.0501
71691065|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.99||||0.013|TWO_SIDED|90.0|0.68|3.3|||ANCOVA|||Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.30|0.68|0.013
71933881|NCT00106028|143388911|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.608||||0.2141|TWO_SIDED|95.0|0.262|1.41||Other Non-Vertebral Fracture|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.410|0.262|0.2141
71933882|NCT00106028|143388912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416||95.0|0.348|0.98||All Fractures|Wald test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
71933883|NCT00106028|143388912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.584||||0.0416|TWO_SIDED|95.0|0.348|0.98||Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.980|0.348|0.0416
71933884|NCT00106028|143388912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.543||||0.0799|TWO_SIDED|95.0|0.274|1.076||Long Bone Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.076|0.274|0.0799
71933885|NCT00106028|143388912|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.682||||0.682|TWO_SIDED|95.0|0.304|1.532||Other Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||1.532|0.304|0.682
71691066|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27||||0.736|TWO_SIDED|90.0|-1.04|1.57|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.57|-1.04|0.736
71691067|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68||||0.386|TWO_SIDED|90.0|-1.96|0.61|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||0.61|-1.96|0.386
71691068|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.05||||0.948|TWO_SIDED|90.0|-1.35|1.24|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.24|-1.35|0.948
71691069|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.09||||0.908|TWO_SIDED|90.0|-1.41|1.22|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.41|0.908
71691070|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.97||||0.015|TWO_SIDED|90.0|0.65|3.28|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.28|0.65|0.015
71691071|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.046|TWO_SIDED|90.0|0.29|2.92|||ANCOVA|||Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.92|0.29|0.046
71691072|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.6||||0.042|TWO_SIDED|90.0|0.31|2.89|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.89|0.31|0.042
71691073|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.06||||0.94|TWO_SIDED|90.0|-1.22|1.34|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.34|-1.22|0.940
71691074|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.24||||0.114|TWO_SIDED|90.0|-0.05|2.53|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.53|-0.05|0.114
71933886|NCT00106028|143388913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-11.678||||0.0318||95.0|-22.325|-1.031|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-1.031|-22.325|0.0318
71933887|NCT00106028|143388914|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.067||||0.9907|TWO_SIDED|95.0|-11.401|11.536|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||11.536|-11.401|0.9907
71933888|NCT00106028|143388915|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.686||||0.3826|TWO_SIDED|95.0|-15.276|5.903|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||5.903|-15.276|0.3826
71933889|NCT00106028|143388916|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.629|||<|0.0001||95.0|-38.089|-15.169|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||-15.169|-38.089|<0.0001
71933890|NCT00106028|143388917|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.04||||0.3075|TWO_SIDED|95.0|-8.433|26.512|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||26.512|-8.433|0.3075
71933891|NCT00106028|143388918|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-5.039||||0.3998|TWO_SIDED|95.0|-16.849|6.772|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||6.772|-16.849|0.3998
71933892|NCT00106028|143388919|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.352||||0.1592||95.0|-0.845|0.14|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.140|-0.845|0.1592
71933893|NCT00106028|143388920|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.127||||0.2917||95.0|-0.111|0.365|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.365|-0.111|0.2917
71933894|NCT00106028|143388921|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.007||||0.9622||95.0|-0.304|0.319|||ANOVA|LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.319|-0.304|0.9622
71933895|NCT00106028|143388922|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.009||||0.9596|TWO_SIDED|95.0|-0.336|0.354|||ANOVA|LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.354|-0.336|0.9596
71933896|NCT00106028|143388923|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.107||||0.34||95.0|-0.114|0.328|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.328|-0.114|0.3400
71933897|NCT00106028|143388924|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.029||||0.6218|TWO_SIDED|95.0|-0.084|0.142|||ANOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.||0.142|-0.084|0.6218
71933898|NCT03276962|143388958|SUPERIORITY||Incremental vaccine efficacy|-21.0||||0.154|TWO_SIDED|95.0|-57.0|7.0|||Regression, Cox|The 95% Confidence Interval of the incremental vaccine efficacy estimates was calculated from Cox regression model.||To demonstrate the superiority of a 3-dose schedule of GSK Biologicals' malaria vaccine RTS,S/AS01E with a fractional third dose at Month 2 (Fx012-14-mFxD Group) compared to a standard schedule of RTS,S/AS01E with 3 full doses (R012-20 + R012-14 Group) in terms of vaccine efficacy against clinical malaria (primary case definition) over 12 months post-Dose 3.||7|-57|0.154
71933899|NCT00449930|143388984|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus metformin) to be less than 0.4%.|Mean Difference (Net)|0.14|STANDARD_DEVIATION|0.57||||95.0|0.06|0.21|||||Based on an analysis of covariance (ANCOVA) model with terms for treatment group and baseline value.|||0.21|0.06|
71933900|NCT00449930|143388985|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.3|||<|0.001||95.0|-10.6|-4.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with diarrhea.~Wilson Score method was used for the 95% Confidence Interval (CI)."|||-4.2|-10.6|<0.001
71933901|NCT00449930|143388986|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.9||||0.032||95.0|-3.9|-0.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with nausea.~Wilson Score method was used for the 95% CI."|||-0.2|-3.9|0.032
71933902|NCT00449930|143388987|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.7||||0.103||95.0|-4.0|0.3|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with abdominal pain.~Wilson Score method was used for the 95% CI."|||0.3|-4.0|0.103
71933903|NCT00449930|143388988|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.0||||||95.0|-2.4|0.2|||||"Difference (sitagliptin minus metformin) in the percentage of patients with vomiting.~Wilson Score method was used for the 95% CI."|||0.2|-2.4|
71933904|NCT02295280|143389007|SUPERIORITY|||||||0.14||||||Reduction in pain scores by at least 2 units six hours post administration|Mann Whitney U test|Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.||A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.||||0.14
71933905|NCT03001011|143389017|SUPERIORITY||Median difference (Renvela - Placebo)|-0.21|||<|0.0001|TWO_SIDED|||||Threshold for statistical significance at 0.05.|Wilcoxon rank sum test||Renvela Vs. Placebo|A hierarchical testing procedure was used to control type I error \& handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.||||<0.0001
71933906|NCT00065065|143389041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.0||||0.005||95.0|1.5|10.5|||Regression, Logistic|||||10.5|1.5|.005
71933907|NCT00397839|143389044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.58|||<|0.001||95.0|1.41|3.76|||ANCOVA|||||3.76|1.41|<0.001
71933908|NCT00397839|143389045|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.86||||0.118||95.0|-0.22|1.94|||ANCOVA|||||1.94|-0.22|0.118
71933909|NCT00397839|143389046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.13|||<|0.001||95.0|1.34|2.92|||ANCOVA|||Total Hip subgroup||2.92|1.34|<0.001
71933910|NCT00397839|143389046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.43||||0.012||95.0|0.32|2.55|||ANCOVA|||Femoral Neckm subgroup||2.55|0.32|0.012
71933911|NCT00397839|143389046|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.72||||0.004||95.0|0.56|2.88|||ANCOVA|||Trochanter subgroup||2.88|0.56|0.004
71933912|NCT00397839|143389047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.75|||<|0.001||95.0|1.11|2.4|||ANCOVA|||Total Hip subgroup||2.40|1.11|<0.001
71933913|NCT00397839|143389047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Femoral Neck subgroup||2.25|0.11|0.031
71933914|NCT00397839|143389047|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Trochanter subgroup||2.25|0.11|0.031
71933915|NCT00397839|143389048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.91||||0.362||95.0|0.73|1.13|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 6||1.13|0.73|0.362
71933916|NCT00397839|143389048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.85||||0.044||95.0|0.72|1.01|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 12||1.01|0.72|0.044
71933917|NCT00397839|143389048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46|||<|0.001||95.0|0.3|0.72|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 6||0.72|0.30|<0.001
71933918|NCT00397839|143389048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|||<|0.001||95.0|0.41|0.8|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 12||0.80|0.41|<0.001
71933919|NCT00397839|143389048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.41|||<|0.001||95.0|0.23|0.72|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD at Month 6||0.72|0.23|<0.001
71933920|NCT00397839|143389048|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001||95.0|0.33|0.75|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD||0.75|0.33|<0.001
71933921|NCT01241565|143389049|SUPERIORITY_OR_OTHER||Rate of incidence of PAL|10.6|||||TWO_SIDED|95.0|3.9|21.3|||||Incidence of Prolonged Air Leak (PAL) is estimated at between 5-10% in literature. PAL of 10%of evaluable cases was used to determine study success.|||21.3|3.9|
71933922|NCT02278952|143389109|OTHER|Generalized estimating equation-adjusted linear models||||||0.33|||||||GEE-adjusted models|||||||0.33
71933923|NCT02278952|143389110|OTHER|Generalized estimating equation-adjusted linear model|||||<|0.0001|||||||GEE-adjusted linear model|||||||< 0.0001
71933924|NCT02278952|143389111|OTHER|Generalized estimating equation-adjusted linear models||||||0.049|||||||GEE-adjusted linear models|||||||0.049
71933925|NCT02278952|143389112|OTHER|Generalized estimating equation-adjusted linear models||||||0.114|||||||GEE-adjusted linear models|||||||0.114
71933926|NCT02278952|143389113|OTHER|Generalized estimating equation-adjusted linear models||||||0.47|||||||GEE-adjusted linear models|||P-value of tacrolimus dose||||0.470
71933927|NCT02278952|143389113|OTHER|Generalized estimating equation-adjusted linear models||||||0.037|||||||GEE-adjusted linear models|||P-value of Prednisone dose||||0.037
71933928|NCT02278952|143389113|OTHER|Generalized-estimating equation-adjusted linear models||||||0.456|||||||GEE-adjusted linear models|||P-value of mycophenolate mofetil dose||||0.456
71933929|NCT02795780|143389123|OTHER|||||||0.0166||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0166
71933930|NCT02795780|143389123|OTHER|||||||0.0108||||||No adjustments for multiplicity. No a priori threshold defined.|ANCOVA|Adjusted for baseline SUVr, age, and diagnosis group (AD/MCI)||Test of whether difference in least squares mean change is 0||||0.0108
71933931|NCT01010230|143389128|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.69|TWO_SIDED|95.0|-5.59|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-5.59|0.69
71933932|NCT01010230|143389129|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.18||||0.18|TWO_SIDED|95.0|0.0|0.35||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.35|0.00|0.18
71933933|NCT01010230|143389130|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.16||||0.85|TWO_SIDED|95.0|-6.93|9.25||The threshold for significance was established a priori at alpha=0.05|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||9.25|-6.93|0.85
71933934|NCT01010230|143389131|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.19||||0.12|TWO_SIDED|95.0|0.43|5.95||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||5.95|0.43|0.12
71933935|NCT01010230|143389132|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.97|TWO_SIDED|95.0|-4.24|4.05||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage (from general linear model).||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.05|-4.24|0.97
71933936|NCT01010230|143389133|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.34||||0.91|TWO_SIDED|95.0|-4.05|4.68||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||4.68|-4.05|0.91
71933937|NCT01010230|143389134|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.29||||0.4|TWO_SIDED|95.0|-0.69|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.11|-0.69|0.40
71933938|NCT01010230|143389135|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.67||||0.73|TWO_SIDED|95.0|-2.02|3.33||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.||3.33|-2.02|0.73
71933939|NCT01010230|143389136|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.2||||0.08|TWO_SIDED|95.0|0.06|0.34||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.34|0.06|0.08
71933940|NCT01010230|143389137|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.13||||0.17|TWO_SIDED|95.0|0.0|0.26||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.26|0.00|0.17
71933941|NCT01010230|143389138|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.08||||0.38|TWO_SIDED|95.0|-0.04|0.2||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.20|-0.04|0.38
71933942|NCT01010230|143389139|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|-0.02||||0.88|TWO_SIDED|95.0|-0.22|0.18||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.18|-0.22|0.88
71933943|NCT01010230|143389140|NON_INFERIORITY_OR_EQUIVALENCE|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.28||||0.06|TWO_SIDED|95.0|0.09|0.46||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.||0.46|0.09|0.06
71933944|NCT00530439|143389147|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.014
71933945|NCT01963676|143389148|SUPERIORITY_OR_OTHER|||||||0.48|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from Day 5 to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups:~H0: μ1 = μ2 μ1: mean(difference 5 days-baseline) for tDCS group (n=13) μ2: mean(difference 5 days-baseline) for sham group (n=13)"||||0.48
71933946|NCT01963676|143389149|SUPERIORITY_OR_OTHER|||||||0.86|TWO_SIDED|||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from 1 Month to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the AHRS score changes from baseline to 1month between the groups:~H0: μ1 = μ2 μ1: mean(difference 1 month-baseline) for tDCS group (n=13) μ2: mean(difference 1 month-baseline) for sham group (n=13)"||||0.86
71933947|NCT01246973|143389150|SUPERIORITY_OR_OTHER|||||||0.6555|TWO_SIDED||||||F-test|||||||0.6555
71933948|NCT01246973|143389151|SUPERIORITY_OR_OTHER|||||||0.3504|TWO_SIDED||||||Chi-squared|||||||0.3504
71933949|NCT00766506|143389152|SUPERIORITY_OR_OTHER||Least square mean difference|-2.23|||<|0.001|TWO_SIDED|95.0|-2.55|-1.91|||ANCOVA|P-value was calculated from analysis of covariance (ANCOVA), with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-1.91|-2.55|<0.001
71933950|NCT00766506|143389153|SUPERIORITY_OR_OTHER|||||||0.219|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 24||||0.219
71933951|NCT00766506|143389153|SUPERIORITY_OR_OTHER|||||||0.299|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 48||||0.299
71933952|NCT00766506|143389153|SUPERIORITY_OR_OTHER|||||||0.136|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At study discontinuation or withdrawal||||0.136
71933953|NCT00766506|143389154|SUPERIORITY_OR_OTHER||Least square mean difference|-0.52|||<|0.001|TWO_SIDED|95.0|-0.74|-0.3|||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group|||-0.30|-0.74|<0.001
71933954|NCT00766506|143389155|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.81||||0.131|TWO_SIDED|95.0|0.84|3.92|||Mantel Haenszel|P-value was calculated from a Mantel-Haenszel Chi-Squared test.||||3.92|0.84|0.131
71933955|NCT00766506|143389156|SUPERIORITY_OR_OTHER|||||||0.342|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.342
71933956|NCT00766506|143389157|SUPERIORITY_OR_OTHER|||||||0.836|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.||||||0.836
71933957|NCT00766506|143389158|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.0||||0.029|TWO_SIDED|95.0|1.04|24.03|||Chi-squared|||||24.03|1.04|0.029
71933958|NCT00766506|143389160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.23|TWO_SIDED|95.0|0.74|3.53|||Chi-squared|||Paracetamol: P-value was calculated using Chi-squared test.||3.53|0.74|0.230
71933959|NCT00766506|143389160|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.72||||0.163|TWO_SIDED|95.0|0.8|3.7|||Chi-squared|||NSAID's: P-value was calculated using Chi-squared test.||3.70|0.80|0.163
71933960|NCT02496221|143389162|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.0021||||0.1229|TWO_SIDED|95.0|-20.5781|2.5739|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.5739|-20.5781|0.1229
71933961|NCT02496221|143389163|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-545.9585||||0.1291|TWO_SIDED|95.0|-1260.0|168.0858|||Mixed Models Analysis|||||168.0858|-1260.00|0.1291
71933962|NCT02496221|143389165|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.2992||||0.0317|TWO_SIDED|95.0|-31.0762|-1.5223|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||-1.5223|-31.0762|0.0317
71933963|NCT02496221|143389166|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|252.6099||||0.0291|TWO_SIDED|95.0|29.5081|475.7117|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||475.7117|29.5081|0.0291
71933964|NCT02496221|143389167|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3748||||0.7961|TWO_SIDED|95.0|-3.4109|2.6614|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||2.6614|-3.4109|0.7961
71933965|NCT02496221|143389169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001526||||0.9424|TWO_SIDED|95.0|-0.045665|0.048717|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.048717|-0.045665|0.9424
71933966|NCT02496221|143389170|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01456||||0.0733|TWO_SIDED|95.0|-0.030666|0.001554|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect||||0.001554|-0.030666|0.0733
71933967|NCT01893983|143389181|EQUIVALENCE|Compare whether 2 groups had any difference in risk/hazard of mental health engagement at any time during follow-up.|Cox Proportional Hazard|1.13||||0.66|TWO_SIDED|95.0|0.81|1.58||P value 0.05 is the threshold for statistical significance|Regression, Cox|Adjusted for site, mental health treatment history and mental health symptom severity at baseline, baseline amphetamine and opioid scores.|The referral alone arm is the reference group (denominator), and the motivational coaching arm is the numerator.|Compare 2 groups in regard to time to first mental health treatment using Cox proportional hazards regression.||1.58|0.81|0.660
71933968|NCT01120600|143389185|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|5.59|||<|0.001|TWO_SIDED|95.0|4.48|6.7|||cLDA|||A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||6.7|4.48|< 0.001
71933969|NCT01120600|143389186|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.02|||<|0.001|TWO_SIDED|95.0|1.27|2.77|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.77|1.27|< 0.001
71933970|NCT01120600|143389187|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|1.69|||=|0.008|TWO_SIDED|95.0|0.45|2.93|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||2.93|0.45|= 0.008
71933971|NCT01120600|143389188|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|2.12|||<|0.001|TWO_SIDED|95.0|0.93|3.3|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||3.3|0.93|< 0.001
71691075|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.97||||0.228|TWO_SIDED|90.0|-0.35|2.28|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.28|-0.35|0.228
71691076|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.29||||0.005|TWO_SIDED|90.0|0.98|3.6|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.60|0.98|0.005
71933972|NCT01120600|143389189|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-76.58|||<|0.001|TWO_SIDED|95.0|-92.56|-60.61|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-60.61|-92.56|< 0.001
71933973|NCT01120600|143389190|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-68.08|||<|0.001|TWO_SIDED|95.0|-78.1|-58.06|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-58.06|-78.1|< 0.001
71933974|NCT01120600|143389191|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-7.94|||=|0.019|TWO_SIDED|95.0|-14.58|-1.31|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-1.31|-14.58|= 0.019
71691077|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.48||||0.063|TWO_SIDED|90.0|0.17|2.79|||ANCOVA|||Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.79|0.17|0.063
71691078|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.5||||0.562|TWO_SIDED|90.0|-0.92|1.91|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.91|-0.92|0.562
71691079|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.67||||0.431|TWO_SIDED|90.0|-0.73|2.07|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.07|-0.73|0.431
71933975|NCT01120600|143389192|SUPERIORITY_OR_OTHER||Difference in Least Squares Means|-16.0|||=|0.001|TWO_SIDED|95.0|-25.74|-6.27|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.||-6.27|-25.74|= 0.001
71933976|NCT03877237|143389209|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.23||||0.02164|TWO_SIDED|95.0|0.96|8.22||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.22|0.96|0.02164
71933977|NCT03877237|143389210|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|4.17||||0.05842|TWO_SIDED|95.0|0.03|8.33||KCCQ-PLS was tested at the alpha level of 0.04990 because KCCQ-TSS had a statistically significant p-value, in accordance with the pre-specified testing strategy.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.04990~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||8.33|0.03|0.05842
71933978|NCT03877237|143389211|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.2||||0.68626|TWO_SIDED|95.0|-6.5|13.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00010:~H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||13.0|-6.5|0.68626
71933979|NCT03877237|143389212|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|-0.16||||0.19748|TWO_SIDED|95.0|-0.55|0.22||Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||"For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is~* H0: m(r(A)) = m(r(C)) versus~* H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively."||0.22|-0.55|0.19748
71933980|NCT00382291|143389250|SUPERIORITY_OR_OTHER|||||||0.2106||95.0|||||Kruskal-Wallis|||Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.||||.2106
71933981|NCT00382291|143389251|SUPERIORITY_OR_OTHER|||||||0.8831|TWO_SIDED|95.0|||||ANCOVA|||Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.||||.8831
71933982|NCT01681771|143389269|SUPERIORITY|||||||0.21|||||||ANCOVA|ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline||||||0.21
71933983|NCT03154333|143389270|OTHER||Risk Ratio (RR)|1.01||||0.9666|TWO_SIDED|95.0|0.63|1.62|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||1.62|0.63|0.9666
71933984|NCT03154333|143389271|OTHER||Risk Ratio (RR)|1.53||||0.2861|TWO_SIDED|95.0|0.41|3.28|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.||||3.28|0.41|0.2861
71933985|NCT00361257|143389272|SUPERIORITY_OR_OTHER||Slope|0.064|STANDARD_ERROR_OF_MEAN|0.164||0.651|TWO_SIDED|95.0|-0.258|0.386||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.|The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).|The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.||0.386|-0.258|0.651
71933986|NCT00361257|143389273|SUPERIORITY_OR_OTHER||Slope|0.091|STANDARD_ERROR_OF_MEAN|0.116||0.434|TWO_SIDED|95.0|-0.14|0.323||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.||The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.||0.323|-0.140|0.434
71933987|NCT00361257|143389274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.569|STANDARD_DEVIATION|0.469||0.337|TWO_SIDED|95.0|0.625|3.936||The p-value was not adjusted for multiple comparisons.|Regression, Cumulative Logistic|The model was adjusted for the stratification variables and the CNS penetration score.||The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.||3.936|0.625|0.337
71933988|NCT00361257|143389275|SUPERIORITY_OR_OTHER||Slope|0.502|STANDARD_ERROR_OF_MEAN|0.428||0.243|TWO_SIDED|95.0|-0.349|1.354||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.||The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.||1.354|-0.349|0.243
71933989|NCT00361257|143389276|SUPERIORITY_OR_OTHER||Slope|0.293|STANDARD_ERROR_OF_MEAN|0.153||0.059|TWO_SIDED|95.0|-0.011|0.596||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.||The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.||0.596|-0.011|0.059
71933990|NCT00361257|143389277|SUPERIORITY_OR_OTHER||Slope|-0.083|STANDARD_ERROR_OF_MEAN|0.147||0.572|TWO_SIDED|95.0|-0.375|0.209||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.||The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.||0.209|-0.375|0.572
71933991|NCT00361257|143389278|SUPERIORITY_OR_OTHER||Slope|-0.086|STANDARD_ERROR_OF_MEAN|0.182||0.637|TWO_SIDED|95.0|-0.449|0.276||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.||The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.||0.276|-0.449|0.637
71933992|NCT00361257|143389279|SUPERIORITY_OR_OTHER||Slope|-0.074|STANDARD_ERROR_OF_MEAN|0.236||0.754|TWO_SIDED|95.0|-0.544|0.396||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.||The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.||0.396|-0.544|0.754
71933993|NCT00361257|143389280|SUPERIORITY_OR_OTHER||Slope|0.145|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.||The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
71933994|NCT00361257|143389281|SUPERIORITY_OR_OTHER||Slope|-0.126|STANDARD_ERROR_OF_MEAN|0.172||0.467|TWO_SIDED|95.0|-0.467|0.216||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.||The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.||0.216|-0.467|0.467
71933995|NCT00361257|143389282|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.476|STANDARD_DEVIATION|1.048||0.234|TWO_SIDED|95.0|0.575|10.668||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.||"The null hypothesis was that the proportion of being better at 24 weeks in minocycline group was the same as in the placebo group."||10.668|0.575|0.234
71933996|NCT00361257|143389283|SUPERIORITY_OR_OTHER||Slope|19.09|STANDARD_ERROR_OF_MEAN|33.75||0.574|TWO_SIDED|95.0|-48.26|86.44||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.||The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.||86.44|-48.26|0.574
71933997|NCT00361257|143389284|SUPERIORITY_OR_OTHER||Slope|40.43|STANDARD_ERROR_OF_MEAN|59.91||0.502|TWO_SIDED|95.0|-79.12|159.97||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.||The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.||159.97|-79.12|0.502
71691080|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.22||||0.795|TWO_SIDED|90.0|-1.18|1.62|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-1.18|0.795
71933998|NCT00361257|143389285|SUPERIORITY_OR_OTHER|||||||0.967||95.0|||||Log Rank|||The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.||||0.967
71933999|NCT00361257|143389287|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.071|STANDARD_ERROR_OF_MEAN|0.497||0.89|TWO_SIDED|95.0|0.405|2.837||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|The model was adjusted for the stratification variables and the baseline CNS penetration score.||The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.||2.837|0.405|0.890
71934000|NCT00361257|143389288|SUPERIORITY_OR_OTHER||Slope|-0.405|STANDARD_ERROR_OF_MEAN|0.391||0.304|TWO_SIDED|95.0|-1.182|0.373||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.||The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.||0.373|-1.182|0.304
71934001|NCT00361257|143389293|SUPERIORITY_OR_OTHER||Slope|-0.097|STANDARD_ERROR_OF_MEAN|0.146||0.506|TWO_SIDED|95.0|-0.388|0.193||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.||The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.||0.193|-0.388|0.506
71934002|NCT00361257|143389294|SUPERIORITY_OR_OTHER||Slope|0.146|STANDARD_ERROR_OF_MEAN|0.207||0.484|TWO_SIDED|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.||The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.||0.558|-0.266|0.484
71934003|NCT00361257|143389295|SUPERIORITY_OR_OTHER||Slope|0.055|STANDARD_ERROR_OF_MEAN|0.137||0.69|TWO_SIDED|95.0|-0.217|0.327||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.||The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.||0.327|-0.217|0.690
71934004|NCT02919475|143389300|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
71934005|NCT02919475|143389300|SUPERIORITY|||||||0.841|||||||Fisher Exact|||||||0.841
71934006|NCT02919475|143389300|SUPERIORITY|||||||0.842|||||||Fisher Exact|||||||0.842
71934007|NCT02919475|143389300|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71934008|NCT02919475|143389301|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71934009|NCT02919475|143389301|SUPERIORITY|||||||0.832|||||||Fisher Exact|||||||0.832
71934010|NCT02919475|143389301|SUPERIORITY|||||||0.682|||||||Fisher Exact|||||||0.682
71934011|NCT02919475|143389301|SUPERIORITY|||||||0.665|||||||Fisher Exact|||||||0.665
71934012|NCT02919475|143389302|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>0.999
71934013|NCT02919475|143389302|SUPERIORITY|||||||0.627|||||||Fisher Exact|||||||0.627
71934014|NCT02919475|143389302|SUPERIORITY|||||||0.794|||||||Fisher Exact|||||||0.794
71934015|NCT02919475|143389302|SUPERIORITY|||||||0.453|||||||Fisher Exact|||||||0.453
71934016|NCT02919475|143389303|SUPERIORITY|||||||0.113|||||||Fisher Exact|||||||0.113
71934017|NCT02919475|143389303|SUPERIORITY|||||||0.024|||||||Fisher Exact|||||||0.024
71934018|NCT02919475|143389303|SUPERIORITY|||||||0.056|||||||Fisher Exact|||||||0.056
71934019|NCT02919475|143389303|SUPERIORITY|||||||0.035|||||||Fisher Exact|||||||0.035
71934020|NCT01928446|143389310|SUPERIORITY||Cox Proportional Hazard|1.1||||0.61|TWO_SIDED|95.0|0.77|1.55|||Log Rank|||Model1 - Treatment only: unadjusted for other covariates||1.55|0.77|0.61
71934021|NCT01928446|143389310|SUPERIORITY||Cox Proportional Hazard|1.08||||0.67|TWO_SIDED|95.0|0.76|1.53|||Log Rank|||Model2 - Treatment only: unadjusted with Site as random Effect||1.53|0.76|0.67
71934022|NCT01928446|143389311|SUPERIORITY||Cox Proportional Hazard|1.49||||0.37|TWO_SIDED|95.0|0.61|3.64|||Log Rank|||||3.64|0.61|0.37
71934023|NCT01928446|143389312|SUPERIORITY||Cox Proportional Hazard|1.14||||0.77|TWO_SIDED|95.0|0.48|2.69|||Log Rank|||Model 5: Non-fatal self-directed violence subgroup||2.69|0.48|0.77
71934024|NCT01928446|143389312|SUPERIORITY||Cox Proportional Hazard|1.61||||0.22|TWO_SIDED|95.0|0.75|3.43|||Log Rank|||Model 6: Interrupted self-directed violence subgroup||3.43|0.75|0.22
71934025|NCT01928446|143389312|SUPERIORITY||Cox Proportional Hazard|0.92||||0.71|TWO_SIDED|95.0|0.58|1.45|||Log Rank|||Model 7: Hospitalization to prevent suicide||1.45|0.58|0.71
71934026|NCT00775983|143389319|NON_INFERIORITY_OR_EQUIVALENCE|Power: We assumed a standard deviation of five minutes based on historical clinic data for surgical abortions during this gestational duration range, a non-inferiority margin of five minutes, and a 10% potential attrition rate to power the study for a non-inferiority hypothesis. Thirty participants in each arm gave us 95% power to conclude non-inferiority of same day Dilapan-S compared to overnight laminaria with respect to procedure time of surgical abortions between 14-18 weeks gestation.|Mean Difference (Final Values)|2.1|||||TWO_SIDED|97.5|-0.3|4.5|||t-test, 2 sided|||Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.||4.5|-0.3|
71934027|NCT00623623|143389324|OTHER||Relative risk|0.86||||0.195|TWO_SIDED|95.0|0.68|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.68|0.195
71934028|NCT00623623|143389325|OTHER||Relative risk|1.03||||0.904|TWO_SIDED|95.0|0.68|1.55|||modified Poisson regression|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.55|0.68|0.904
71934029|NCT00623623|143389326|OTHER||Relative risk|0.97||||0.905|TWO_SIDED|95.0|0.6|1.58|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.58|0.60|0.905
71934030|NCT00623623|143389327|SUPERIORITY_OR_OTHER||Relative risk|0.73||||0.12|TWO_SIDED|95.0|0.49|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.08|0.49|0.120
71934031|NCT00623623|143389328|OTHER||Relative risk|0.79||||0.17|TWO_SIDED|95.0|0.57|1.11|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.11|0.57|0.170
71934032|NCT00623623|143389329|OTHER||Relative risk|1.1||||0.758|TWO_SIDED|95.0|0.61|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.61|0.758
71934033|NCT00623623|143389330|OTHER||Relative risk|1.1||||0.663|TWO_SIDED|95.0|0.73|1.66|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.66|0.73|0.663
71934034|NCT00623623|143389331|OTHER||Relative risk|1.72||||0.148|TWO_SIDED|95.0|0.82|3.6|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||3.60|0.82|0.148
71934035|NCT00623623|143389332|OTHER||Relative risk|0.5||||0.572|TWO_SIDED|95.0|0.05|5.52|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.52|0.05|0.572
71934036|NCT00623623|143389333|OTHER||Relative risk|0.81||||0.207|TWO_SIDED|95.0|0.58|1.13|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.13|0.58|0.207
71934037|NCT00623623|143389334|OTHER||Relative risk|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.04|0.63|0.100
71934038|NCT00623623|143389335|OTHER||Relative Risk|0.91||||0.511|TWO_SIDED|95.0|0.67|1.22|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.22|0.67|0.511
71934039|NCT00623623|143389336|OTHER||Relative Risk|1.75||||0.369|TWO_SIDED|95.0|0.52|5.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||5.97|0.52|0.369
71934040|NCT00623623|143389337|OTHER||Relative Risk|4.99||||0.168|TWO_SIDED|95.0|0.51|49.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||49.08|0.51|0.168
71934041|NCT00623623|143389338|OTHER||Relative Risk|8.02||||0.049|TWO_SIDED|95.0|1.0|63.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||63.97|1.00|0.049
71934042|NCT00623623|143389339|OTHER||Relative Risk|4.51||||0.054|TWO_SIDED|95.0|0.98|20.82|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||20.82|0.98|0.054
71934043|NCT00623623|143389340|OTHER||Relative Risk|2.0||||0.324|TWO_SIDED|95.0|0.5|7.99|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||7.99|0.50|0.324
71934044|NCT00623623|143389341|OTHER||Relative Risk|3.01||||0.032|TWO_SIDED|95.0|1.1|8.24|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||8.24|1.10|0.032
71934045|NCT00623623|143389342|OTHER||Relative Risk|1.36||||0.111|TWO_SIDED|95.0|0.93|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.97|0.93|0.111
71934046|NCT00623623|143389343|OTHER||Relative Risk|1.08||||0.397|TWO_SIDED|95.0|0.91|1.28|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.28|0.91|0.397
71934047|NCT00623623|143389344|OTHER||Relative Risk|1.13||||0.107|TWO_SIDED|95.0|0.97|1.31|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.31|0.97|0.107
71934048|NCT00623623|143389345|OTHER||Relative Risk|0.84||||0.471|TWO_SIDED|95.0|0.53|1.34|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||1.34|0.53|0.471
71934049|NCT00623623|143389346|SUPERIORITY||Relative Risk|0.35||||0.003|TWO_SIDED|95.0|0.17|0.71|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.||0.71|0.17|0.003
71691081|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83||||0.032|TWO_SIDED|90.0|0.43|3.23|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.23|0.43|0.032
71934050|NCT00623623|143389347|OTHER||Relative risk|1.17||||0.451|TWO_SIDED|95.0|0.78|1.73|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.73|0.78|0.451
71934051|NCT00623623|143389348|OTHER||Relative Risk|0.87||||0.22|TWO_SIDED|95.0|0.69|1.09|||modified Poisson regression model|modified Poisson regression model with robust error variance||||1.09|0.69|0.220
71691082|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.73||||0.002|TWO_SIDED|90.0|1.34|4.13|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.13|1.34|0.002
71934052|NCT02499354|143389349|SUPERIORITY|||||||0.2742|||||||t-test, 1 sided|||||||0.2742
71934053|NCT02499354|143389350|SUPERIORITY|||||||0.55|||||||Chi-squared|||||||0.55
71934054|NCT01427920|143389359|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.25||||||95.0|0.04|0.46|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||FAS||0.46|0.04|
71934055|NCT01427920|143389360|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.26||||||95.0|0.05|0.48|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline HbA1c as covariate.||PP||0.48|0.05|
71934056|NCT01427920|143389361|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.13||||0.659||95.0|-0.44|0.69|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.||H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).||0.69|-0.44|0.659
71934057|NCT01202994|143389374|OTHER||correlation coefficient|-0.45|||<|0.05|TWO_SIDED|||||This is a calculated p-value.|correlation|||The primary analysis is to examine the correlation between the practice effect z-score (presented in the Secondary Outcome section) and the standardized uptake value of flutemetamol (presented in the Outcome module).||||<0.05
71934058|NCT00837577|143389404|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.92|STANDARD_ERROR_OF_MEAN|0.09|<|0.001|TWO_SIDED|95.0|-1.09|-0.75||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-0.75|-1.09|<.001
71934059|NCT00837577|143389405|SUPERIORITY_OR_OTHER||Least squares mean difference|-51.3|STANDARD_ERROR_OF_MEAN|5.6|<|0.001|TWO_SIDED|95.0|-62.3|-40.2||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-40.2|-62.3|<.001
71934060|NCT00837577|143389406|SUPERIORITY_OR_OTHER||Least squares mean difference|-22.5|STANDARD_ERROR_OF_MEAN|3.8|<|0.001|TWO_SIDED|95.0|-30.0|-15.0||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.||||-15.0|-30.0|<.001
71934061|NCT00919802|143389407|OTHER|||||||0.688|||||||t-test, 2 sided|||Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.||||0.688
71934062|NCT00919802|143389408|OTHER|paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test||||||0.7252|||||||t-test, 2 sided|||||||0.7252
71934063|NCT00272961|143389410|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|8.37|STANDARD_ERROR_OF_MEAN|6.19||0.185|TWO_SIDED|95.0|-4.21|20.96|||ANCOVA|||Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.||20.96|-4.21|0.185
71934064|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.21|STANDARD_ERROR_OF_MEAN|5.59||0.97|TWO_SIDED|95.0|-11.16|11.59|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.59|-11.16|0.970
71934065|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|5.71||0.994|TWO_SIDED|95.0|-11.66|11.57|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.57|-11.66|0.994
71934066|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|5.72||0.861|TWO_SIDED|95.0|-10.62|12.64|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||12.64|-10.62|0.861
71934067|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|6.1|STANDARD_ERROR_OF_MEAN|4.9||0.221|TWO_SIDED|95.0|-3.79|15.99|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||15.99|-3.79|0.221
71934068|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.68|STANDARD_ERROR_OF_MEAN|4.49||0.88|TWO_SIDED|95.0|-8.37|9.73|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.73|-8.37|0.880
71934069|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|4.56||0.9|TWO_SIDED|95.0|-9.78|8.63|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||8.63|-9.78|0.900
71934070|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|-5.71|STANDARD_ERROR_OF_MEAN|4.56||0.218|TWO_SIDED|95.0|-14.91|3.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||3.50|-14.91|0.218
71934071|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|5.62|STANDARD_ERROR_OF_MEAN|2.68||0.044|TWO_SIDED|95.0|0.17|11.08|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.08|0.17|0.044
71934072|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|1.43|STANDARD_ERROR_OF_MEAN|2.41||0.557|TWO_SIDED|95.0|-3.47|6.33|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.33|-3.47|0.557
71934073|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|6.37|STANDARD_ERROR_OF_MEAN|2.5||0.016|TWO_SIDED|95.0|1.28|11.45|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||11.45|1.28|0.016
71934074|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.99|STANDARD_ERROR_OF_MEAN|2.5||0.695|TWO_SIDED|95.0|-4.09|6.07|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.07|-4.09|0.695
71934075|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|2.56||0.067|TWO_SIDED|95.0|-0.36|9.95|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||9.95|-0.36|0.067
71934076|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|2.36||0.737|TWO_SIDED|95.0|-3.96|5.55|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||5.55|-3.96|0.737
71934077|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|5.64|STANDARD_ERROR_OF_MEAN|2.4||0.023|TWO_SIDED|95.0|0.8|10.47|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||10.47|0.80|0.023
71934078|NCT00272961|143389410|SUPERIORITY_OR_OTHER||LS Mean Difference|1.65|STANDARD_ERROR_OF_MEAN|2.4||0.495|TWO_SIDED|95.0|-3.2|6.5|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.||6.50|-3.20|0.495
71934079|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|232.59|STANDARD_ERROR_OF_MEAN|201.83||0.2577|TWO_SIDED|95.0|-178.5|643.7|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||643.7|-178.5|0.2577
71934080|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|103.67|STANDARD_ERROR_OF_MEAN|173.86||0.5552|TWO_SIDED|95.0|-250.5|457.8|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||457.8|-250.5|0.5552
71691083|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.017|TWO_SIDED|90.0|0.64|3.44|||ANCOVA|||Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.44|0.64|0.017
71934081|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|41.26|STANDARD_ERROR_OF_MEAN|177.26||0.8174|TWO_SIDED|95.0|-319.8|402.3|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||402.3|-319.8|0.8174
71934082|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|166.4|STANDARD_ERROR_OF_MEAN|177.55||0.3557|TWO_SIDED|95.0|-195.3|528.1|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||528.1|-195.3|0.3557
71934083|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|163.04|STANDARD_ERROR_OF_MEAN|130.15||0.2172|TWO_SIDED|95.0|-99.6|425.7|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||425.7|-99.6|0.2172
71934084|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|115.35|STANDARD_ERROR_OF_MEAN|116.03||0.3258|TWO_SIDED|95.0|-118.8|349.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||349.5|-118.8|0.3258
71934085|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|24.67|STANDARD_ERROR_OF_MEAN|117.88||0.8352|TWO_SIDED|95.0|-213.2|262.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||262.6|-213.2|0.8352
71934086|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|50.59|STANDARD_ERROR_OF_MEAN|117.93||0.6701|TWO_SIDED|95.0|-187.4|288.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||288.6|-187.4|0.6701
71934087|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|225.57|STANDARD_ERROR_OF_MEAN|108.95||0.0466|TWO_SIDED|95.0|3.6|447.5|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||447.5|3.6|0.0466
71934088|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|114.77|STANDARD_ERROR_OF_MEAN|93.2637||0.2274|TWO_SIDED|95.0|-75.2|304.8|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||304.8|-75.2|0.2274
71934089|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|224.89|STANDARD_ERROR_OF_MEAN|96.9259||0.0269|TWO_SIDED|95.0|27.5|422.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||422.3|27.5|0.0269
71934090|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|133.22|STANDARD_ERROR_OF_MEAN|96.7383||0.178|TWO_SIDED|95.0|-63.8|330.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||330.3|-63.8|0.1780
71934091|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|240.64|STANDARD_ERROR_OF_MEAN|114.32||0.0413|TWO_SIDED|95.0|9.9|471.4|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||471.4|9.9|0.0413
71934092|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|157.99|STANDARD_ERROR_OF_MEAN|102.21||0.1297|TWO_SIDED|95.0|-48.3|364.3|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||364.3|-48.3|0.1297
71934093|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|254.9|STANDARD_ERROR_OF_MEAN|104.0||0.0185|TWO_SIDED|95.0|45.0|464.8|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||464.8|45.0|0.0185
71934094|NCT00272961|143389411|SUPERIORITY_OR_OTHER||LS Mean Difference|157.66|STANDARD_ERROR_OF_MEAN|104.33||0.1382|TWO_SIDED|95.0|-52.9|368.2|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.||368.2|-52.9|0.1382
71934095|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|3.0||0.7758|TWO_SIDED|95.0|-5.31|7.03|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.03|-5.31|0.7758
71934096|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|2.45||0.888|TWO_SIDED|95.0|-5.4|4.71|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||4.71|-5.40|0.8880
71934097|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|1.86|STANDARD_ERROR_OF_MEAN|2.46||0.4573|TWO_SIDED|95.0|-3.21|6.93|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||6.93|-3.21|0.4573
71934098|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|2.17|STANDARD_ERROR_OF_MEAN|2.78||0.4424|TWO_SIDED|95.0|-3.56|7.91|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||7.91|-3.56|0.4424
71934099|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|3.18|STANDARD_ERROR_OF_MEAN|3.32||0.347|TWO_SIDED|95.0|-3.65|10.01|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||10.01|-3.65|0.3470
71934100|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|1.34|STANDARD_ERROR_OF_MEAN|2.72||0.6249|TWO_SIDED|95.0|-4.25|6.94|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||6.94|-4.25|0.6249
71934101|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|3.92|STANDARD_ERROR_OF_MEAN|2.73||0.1625|TWO_SIDED|95.0|-1.69|9.54|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||9.54|-1.69|0.1625
71934102|NCT00272961|143389416|SUPERIORITY_OR_OTHER||LS Mean Difference|0.97|STANDARD_ERROR_OF_MEAN|3.08||0.7556|TWO_SIDED|95.0|-5.38|7.31|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||7.31|-5.38|0.7556
71934103|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.99|STANDARD_ERROR_OF_MEAN|1.59||0.0714|TWO_SIDED|95.0|-6.25|0.28|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||0.28|-6.25|0.0714
71934104|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|0.47|STANDARD_ERROR_OF_MEAN|1.34||0.7269|TWO_SIDED|95.0|-2.29|3.24|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.24|-2.29|0.7269
71934105|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|0.23|STANDARD_ERROR_OF_MEAN|1.36||0.8656|TWO_SIDED|95.0|-2.58|3.04|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||3.04|-2.58|0.8656
71934106|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4||0.7113|TWO_SIDED|95.0|-3.41|2.36|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.||2.36|-3.41|0.7113
71934107|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.77|STANDARD_ERROR_OF_MEAN|2.21||0.2204|TWO_SIDED|95.0|-7.32|1.77|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.77|-7.32|0.2204
71934108|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.19|STANDARD_ERROR_OF_MEAN|1.87||0.5298|TWO_SIDED|95.0|-5.04|2.66|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||2.66|-5.04|0.5298
71934109|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.95|STANDARD_ERROR_OF_MEAN|1.9||0.3135|TWO_SIDED|95.0|-5.86|1.96|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.96|-5.86|0.3135
71934110|NCT00272961|143389417|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.08|STANDARD_ERROR_OF_MEAN|1.95||0.2962|TWO_SIDED|95.0|-6.09|1.93|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.||1.93|-6.09|0.2962
71934111|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.74|STANDARD_ERROR_OF_MEAN|5.39||0.4933|TWO_SIDED|95.0|-14.84|7.35|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.35|-14.84|0.4933
71934112|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.85|STANDARD_ERROR_OF_MEAN|4.57||0.408|TWO_SIDED|95.0|-13.26|5.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.57|-13.26|0.4080
71934113|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.47|STANDARD_ERROR_OF_MEAN|4.56||0.5936|TWO_SIDED|95.0|-11.86|6.93|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.93|-11.86|0.5936
71934114|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|4.79||0.7883|TWO_SIDED|95.0|-11.17|8.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.57|-11.17|0.7883
71934115|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|5.12||0.5719|TWO_SIDED|95.0|-13.46|7.6|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||7.60|-13.46|0.5719
71934116|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.21|STANDARD_ERROR_OF_MEAN|4.33||0.3401|TWO_SIDED|95.0|-13.11|4.7|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||4.70|-13.11|0.3401
71934117|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|4.34||0.6329|TWO_SIDED|95.0|-11.01|6.82|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.82|-11.01|0.6329
71934118|NCT00272961|143389418|SUPERIORITY_OR_OTHER||LS Mean Difference|3.83|STANDARD_ERROR_OF_MEAN|4.51||0.4037|TWO_SIDED|95.0|-5.45|13.11|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||13.11|-5.45|0.4037
71934119|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|1.21|STANDARD_ERROR_OF_MEAN|4.08||0.7685|TWO_SIDED|95.0|-7.19|9.62|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||9.62|-7.19|0.7685
71934120|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.88|STANDARD_ERROR_OF_MEAN|3.49||0.1739|TWO_SIDED|95.0|-12.07|2.3|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||2.30|-12.07|0.1739
71934121|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|2.71|STANDARD_ERROR_OF_MEAN|3.61||0.4612|TWO_SIDED|95.0|-4.74|10.15|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||10.15|-4.74|0.4612
71934122|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.34|STANDARD_ERROR_OF_MEAN|3.67||0.7172|TWO_SIDED|95.0|-8.9|6.21|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||6.21|-8.90|0.7172
71934123|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|3.45|STANDARD_ERROR_OF_MEAN|4.12||0.4098|TWO_SIDED|95.0|-5.01|11.91|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||11.91|-5.01|0.4098
71934124|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.38|STANDARD_ERROR_OF_MEAN|3.48||0.6943|TWO_SIDED|95.0|-8.54|5.78|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||5.78|-8.54|0.6943
71934125|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|4.78|STANDARD_ERROR_OF_MEAN|3.67||0.2042|TWO_SIDED|95.0|-2.76|12.31|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||12.31|-2.76|0.2042
71934126|NCT00272961|143389419|SUPERIORITY_OR_OTHER||LS Mean Difference|1.07|STANDARD_ERROR_OF_MEAN|3.77||0.7791|TWO_SIDED|95.0|-6.69|8.83|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.||8.83|-6.69|0.7791
71934127|NCT02065791|143389420|SUPERIORITY||Hazard Ratio (HR)|0.7|||<|0.0001|TWO_SIDED|95.0|0.59|0.82|||Cox Proportional Hazard|||Comparison for canagliflozin versus placebo is reported here.||0.82|0.59|< 0.0001
71934128|NCT02065791|143389421|SUPERIORITY||Hazard Ratio (HR)|0.69|||=|0.0001|TWO_SIDED|95.0|0.57|0.83|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.83|0.57|=0.0001
71934129|NCT02065791|143389422|SUPERIORITY||Hazard Ratio (HR)|0.8|||=|0.0121|TWO_SIDED|95.0|0.67|0.95|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||0.95|0.67|=0.0121
71934130|NCT02065791|143389423|SUPERIORITY||Hazard Ratio (HR)|0.61|||=|0.0003|TWO_SIDED|95.0|0.47|0.8|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.80|0.47|=0.0003
71691084|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.26||||0.124|TWO_SIDED|90.0|-0.09|2.6|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.60|-0.09|0.124
71934131|NCT02065791|143389424|SUPERIORITY||Hazard Ratio (HR)|0.66|||<|0.0001|TWO_SIDED|95.0|0.53|0.81|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.81|0.53|<0.0001
71934132|NCT02065791|143389425|SUPERIORITY||Hazard Ratio (HR)|0.78|||=|0.0502|TWO_SIDED|95.0|0.61|1.0|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||1.00|0.61|=0.0502
71934133|NCT02065791|143389426|SUPERIORITY||Hazard Ratio (HR)|0.83|||=|0.0727|TWO_SIDED|95.0|0.68|1.02|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.||1.02|0.68|= 0.0727
71934134|NCT02065791|143389427|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.0001|TWO_SIDED|95.0|0.63|0.86|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.||0.86|0.63|0.0001
71934135|NCT04428502|143389437|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.6|||||||Student's t-test|||At Month 1: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.6
71934136|NCT04428502|143389437|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.007|||||||Student's t-test|||At Month 6: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.007
71934137|NCT04428502|143389437|EQUIVALENCE|Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.||||||0.004|||||||Student's t-test|||At Month 12: P-value \<0.05 was considered statistically significant, without multiplicity adjustment.||||0.004
71934138|NCT03550794|143389462|OTHER||Mean Difference (Final Values)|-0.57||||0.07|TWO_SIDED|95.0|-1.18|0.04||"Mixed model controlling for repeated measures within patients used to get a mean difference in creatinine between the thiamine and placebo groups at 72 hours.~Missing creatinine imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.04|-1.18|0.07
71934139|NCT03550794|143389463|OTHER||Odds Ratio (OR)|0.58||||0.34|TWO_SIDED|95.0|0.18|1.74||P-value from odds ratio from logistic regression model controlling for site, with outcome of receiving renal replacement therapy.|Regression, Logistic|||||1.74|0.18|0.34
71934140|NCT03550794|143389464|OTHER||Median Difference (Final Values)|22.0||||0.002|TWO_SIDED|95.0|7.4|36.6||P-value from quantile regression model controlling for site.|Quantile regression|||||36.6|7.4|0.002
71934141|NCT03550794|143389465|OTHER||Hazard Ratio (HR)|0.62||||0.14|TWO_SIDED|95.0|0.32|1.18||P-value from Cox proportional hazards model adjusting for site.|Regression, Cox|||||1.18|0.32|0.14
71934142|NCT03550794|143389466|OTHER||Odds Ratio (OR)|0.43||||0.07|TWO_SIDED|95.0|0.17|1.06||P-value from logistic regression model controlling for site|Regression, Logistic|||||1.06|0.17|0.07
71934143|NCT03550794|143389467|OTHER||Mean Difference (Final Values)|0.96||||0.79|TWO_SIDED|95.0|0.71|1.3||"Mixed model controlling for repeated measures within patients used to get a mean difference in lactate between the thiamine and placebo groups at 72 hours.~Missing lactate imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||1.30|0.71|0.79
71934144|NCT03550794|143389469|OTHER||Mean Difference (Final Values)|-1.53||||0.16|TWO_SIDED|95.0|-3.63|0.58||"Mixed model controlling for repeated measures within patients used to get a mean difference in SOFA scores between the thiamine and placebo groups at 72 hours.~Missing SOFA imputed using a penalty (20pc increase) as described in SAP."|Mixed Models Analysis|P-value is for the comparison at 72 hours from the mixed model (i.e, not a global p-value)||||0.58|-3.63|0.16
71934145|NCT01864525|143389471|SUPERIORITY|||||||0.0216||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0216
71934146|NCT01864525|143389471|SUPERIORITY|||||||0.0499||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0499
71934147|NCT01864525|143389471|SUPERIORITY|||||||0.0339||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0339
71934148|NCT01864525|143389471|SUPERIORITY|||||||0.045||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P\<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein \& Rosenfeld, 1985).||||0.0450
71691085|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.08||||0.92|TWO_SIDED|90.0|-1.25|1.41|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.41|-1.25|0.920
71934149|NCT01864525|143389472|SUPERIORITY|||||||0.7172||||||A priori significance was set at P\<0.05 for this hypothesis-driven auditory-perceptual variable. Main effect for drug is given above. For the main task effect, P=0.9602. For the interaction effect of drug\*task, P=0.1699.|Mixed Models Analysis|||Statistical modeling tested for main effects of auditory-perceptual ratings for drug and task (sustained vowel and sentence-level ratings), and interaction effects of these variables. The summed scores, averaged across all participants, are provided separately for the sustained vowel and sentence-level ratings. Values range from 0 (no difference between baseline and post-test) to 3 (all three raters indicated that post-test sample was better (less tremor severity).||||0.7172
71934150|NCT00575328|143389475|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in ASEX score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|1.8|STANDARD_DEVIATION|3.3||0.62|TWO_SIDED|95.0|-8.7|12.3||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in ASEX score) between treatment arms. No formal power analysis was carried out, given the small study sample.|The analysis is not truly informative, since the analyzable sample (n=6) was too small. Results should be viewed with caution.|12.3|-8.7|0.62
71934151|NCT00575328|143389476|SUPERIORITY|Analysis is a test of statistical significance to evaluate whether the results are consistent with the assumption of there being no difference in the clinical improvement (i.e. change in MGH-SD score) of the two treatments (null hypothesis).|Mean Difference (Final Values)|3.6|STANDARD_DEVIATION|4.5||0.38|TWO_SIDED|95.0|-6.7|13.97||No adjustment for multiple comparisons. P value for significance set a priori at P\<0.05.|t-test, 2 sided|||Null hypothesis: There will be no difference in clinical improvement (i.e. change in MGH-SD score) between treatment arms. No formal power analysis was carried out, given the small study sample.|Analysis was not truly informative since the analyzable sample (n=6) was too small. Results should be interpreted with caution.|13.97|-6.7|0.38
71934152|NCT02522949|143389478|SUPERIORITY|||||||0.7146|||||||ANCOVA|||Oropharyngeal||||0.7146
71934153|NCT02522949|143389478|SUPERIORITY|||||||0.3543|||||||ANCOVA|||Nasal||||0.3543
71934154|NCT02522949|143389486|OTHER|||||||0.0232|||||||Exact Wilcoxon rank sum test|||||||0.0232
71934155|NCT04128696|143389515|SUPERIORITY||Hazard Ratio (HR)|1.51||||0.973|TWO_SIDED|95.0|0.99|2.29||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.29|0.99|0.973
71934156|NCT04128696|143389516|SUPERIORITY||Hazard Ratio (HR)|4.44|||>|0.999|TWO_SIDED|95.0|2.01|9.82||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||9.82|2.01|>0.999
71934157|NCT04128696|143389517|SUPERIORITY||Hazard Ratio (HR)|1.4||||0.989|TWO_SIDED|95.0|1.05|1.86||Nominal p-value was calculated based on the log-rank test, stratified by stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.86|1.05|0.989
71934158|NCT04128696|143389518|SUPERIORITY||Hazard Ratio (HR)|1.48||||0.996|TWO_SIDED|95.0|1.1|1.99||Nominal p-value was calculated based on the log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||1.99|1.10|0.996
71934159|NCT04128696|143389519|SUPERIORITY||Hazard Ratio (HR)|1.55|||||TWO_SIDED|95.0|0.98|2.43|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx)||2.43|0.98|
71934160|NCT04128696|143389520|SUPERIORITY||Hazard Ratio (HR)|1.59|||||TWO_SIDED|95.0|1.0|2.53|||Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.53|1.00|
71691086|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12||||0.887|TWO_SIDED|90.0|-1.46|1.22|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.22|-1.46|0.887
71934161|NCT04128696|143389525|OTHER||Difference in Percentage|-5.3|||||TWO_SIDED|95.0|-14.6|4.0||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||4.0|-14.6|
71934162|NCT04128696|143389526|OTHER||Difference in Percentage|-13.3|||||TWO_SIDED|95.0|-27.8|1.5||||||The comparison between the treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||1.5|-27.8|
71934163|NCT04128696|143389527|OTHER||Difference in Percentage|-11.8|||||TWO_SIDED|95.0|-22.4|-1.1||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.1|-22.4|
71934164|NCT04128696|143389528|OTHER||Difference in Percentage|-18.0|||||TWO_SIDED|95.0|-33.7|-1.4||||||The comparison between treatment groups was based on the stratified Miettinen \& Nurminen method with strata weighting by sample size and a single treatment covariate. Stratification factors included HPV status (positive vs. negative). Participants with oropharynx HPV negative/unknown and non-oropharyngeal tumors were combined as the HPV negative group.||-1.4|-33.7|
71934165|NCT04128696|143389537|SUPERIORITY||Hazard Ratio (HR)|1.17||||0.783|TWO_SIDED|95.0|0.78|1.77||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.77|0.78|0.783
71934166|NCT04128696|143389538|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.5|TWO_SIDED|95.0|0.5|2.0||Nominal p-value was calculated based on the log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.50|0.500
71934167|NCT04128696|143389539|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.329|TWO_SIDED|95.0|0.62|1.34||Nominal p-value was calculated based on the one-sided log-rank test, stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by PD-L1 expression (CPS ≥20 vs. 1≤ CPS \<20) and HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||1.34|0.62|0.329
71934168|NCT04128696|143389540|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.608|TWO_SIDED|95.0|0.6|2.0||Nominal p-value was calculated based on the one-sided log-rank test, stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).|Stratified Cox proportional hazard model|||The hazard ratio and 2-sided 95% CI was calculated from the Cox regression model with Efron's method of tie handling, a treatment covariate and stratified by HPV status (oropharynx HPV positive vs oropharynx HPV negative/unknown and non-oropharynx).||2.00|0.60|0.608
71934169|NCT00951899|143389544|SUPERIORITY_OR_OTHER|||||||0.0006||95.0||||A P value \< 0.05 was considered statistically significant|t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Colesevelam subjects||||0.0006
71934170|NCT00951899|143389544|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Placebo subjects||||0.30
71934171|NCT02046369|143389564|SUPERIORITY|The primary efficacy endpoint (the change from baseline in CDRS-R total score at Week 6)will be analyzed using a likelihood-based mixed model for repeated measures (MMRM).The response (dependent) variable is the change from baseline in CDRS-R total score assessed weekly (Weeks 1 to 6).The MMRM model includes fixed effects terms for treatment, visit (as a categorical variable), pooled country, age stratum (stratification factor, CDRS-R total score at baseline, and treatment-by-visit interaction.|LS mean differnce (SE)|-5.7|STANDARD_ERROR_OF_MEAN|1.39|<|0.0001|TWO_SIDED|95.0|-8.4|-3.0|||LS mean differnece (SE)|||A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .||-3.0|-8.4|<0.0001
71934172|NCT02046369|143389565|SUPERIORITY||LS mean differnce (SE)|-1.1|STANDARD_ERROR_OF_MEAN|0.54||0.0385|TWO_SIDED|95.0|-2.2|-0.1|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||-0.1|-2.2|0.0385
71934173|NCT02046369|143389566|SUPERIORITY||LS mean differnce (SE)|3.9|STANDARD_ERROR_OF_MEAN|1.35||0.0044|TWO_SIDED|95.0|1.2|6.5|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||6.5|1.2|0.0044
71934174|NCT02046369|143389567|SUPERIORITY||LS mean differnce (SE)|4.7|STANDARD_ERROR_OF_MEAN|1.19|<|0.0001|TWO_SIDED|95.0|2.4|7.0|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||7.0|2.4|<0.0001
71934175|NCT02046369|143389568|SUPERIORITY||LS mean differnce (SE)|-0.7|STANDARD_ERROR_OF_MEAN|0.77||0.3715|TWO_SIDED|95.0|-2.2|0.8|||ANCOVA|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).||0.8|-2.2|0.3715
71934176|NCT02046369|143389569|SUPERIORITY||LS mean differnce (SE)|-0.44|STANDARD_ERROR_OF_MEAN|0.112|<|0.0001|TWO_SIDED|95.0|-0.66|-0.22||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|LS mean differnece (SE)|||||-0.22|-0.66|<0.0001
71934177|NCT02557672|143389600|SUPERIORITY||Ratio of the Geometric Means|0.98||||0.84|TWO_SIDED|95.0|0.81|1.19|||Regression, Linear|||||1.19|0.81|0.84
71934178|NCT02557672|143389601|SUPERIORITY||Odds Ratio (OR)|0.49||||0.09|TWO_SIDED|95.0|0.22|1.11|||Regression, Logistic|||||1.11|0.22|0.09
71934179|NCT02557672|143389602|SUPERIORITY||Odds Ratio, log|0.76||||0.51|TWO_SIDED|95.0|0.33|1.73|||Regression, Logistic|||||1.73|0.33|0.51
71934180|NCT02557672|143389603|SUPERIORITY||Odds Ratio (OR)|1.39||||0.53|TWO_SIDED|95.0|0.51|3.79|||Regression, Logistic|||||3.79|0.51|0.53
71934181|NCT02557672|143389604|SUPERIORITY||Odds Ratio (OR)|0.52||||0.39|TWO_SIDED|95.0|0.12|2.3|||Regression, Logistic|||||2.30|0.12|0.39
71934182|NCT03705169|143389606|EQUIVALENCE|Confidence Interval (CI) on Geometric Mean Ratio.|Geometric Mean Ratio|3.2|||||TWO_SIDED|95.0|1.9|5.3|||||The ratios of the geometric means (Arm A/Arm C) and the corresponding 95% CI were obtained by exponentiating the least squares mean difference and its 95% CI of the natural log-transformed data.|As dose-normalized AUC 0-12WK values were considered, participants were pooled within Arm (i.e., Arm A participants receiving 1, 3, 10, or 30 mg/kg were pooled and Arm C participants 0.3 or 1.0 mg/kg were pooled).|No comparisons were done with Arm B participants, as only two participants in that arm had available measurements such that AUC 0-12WK could be estimated.|5.3|1.9|
71934183|NCT03705169|143389607|OTHER||Mean|-0.18||||0.26|TWO_SIDED|95.0|-0.53|0.18||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 7 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.18|-0.53|0.26
71934184|NCT03705169|143389609|OTHER||Mean|-0.02||||0.78|TWO_SIDED|95.0|-0.24|0.19||Under the null hypothesis, it was assumed there was no change in HIV-1 RNA (log10 copies/mL) from baseline to Day 14 of SAR441236 monotherapy for viremic participants with HIV (Arm B cohorts).|t-test, 2 sided|||Arm B participants were pooled across doses for analysis.||0.19|-0.24|0.78
71934185|NCT00420290|143389626|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||0.031 is the upper level of significance|ANCOVA|||Using data from 128 CHD patients, CRP data were highly skewed, and data were log transformed to achieve normality. With 14 pts in each group (total of 28), it was predicted the minimum detectable difference between control and intervention would be 15% (1.22 for control group and 1.00 for the intervention group), with an 80% power and an alpha of 0.05 using t test approach. Thus, planned sample size was 30 to complete the study.||||0.008
71934186|NCT00420290|143389627|SUPERIORITY_OR_OTHER|||||||0.03|||||||ANCOVA|||||||0.03
71934187|NCT00420290|143389628|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71934188|NCT00420290|143389629|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71934189|NCT00420290|143389630|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71934190|NCT02092961|143389631|SUPERIORITY_OR_OTHER||Treatment difference|-1.75||||0.022|TWO_SIDED|90.0|-2.75|-0.42||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||-0.42|-2.75|0.022
71934191|NCT02092961|143389631|SUPERIORITY_OR_OTHER||Treatment difference|0.5||||0.402|TWO_SIDED|90.0|-1.0|2.0||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.00|-1.00|0.402
71934192|NCT02092961|143389632|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.746|TWO_SIDED|90.0|-1.0|0.5||A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.50|-1.00|0.746
71934193|NCT02092961|143389632|SUPERIORITY_OR_OTHER||Treatment difference|1.0||||0.413|TWO_SIDED|90.0|-1.5|3.5||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||3.50|-1.50|0.413
71934194|NCT02092961|143389633|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.491|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|0.00|0.491
71934195|NCT02092961|143389633|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.341|TWO_SIDED|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||0.00|0.00|0.341
71934196|NCT02092961|143389634|SUPERIORITY_OR_OTHER||Treatment difference|0.0||||0.366|TWO_SIDED|90.0|-0.5|0.0||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|6 weeks||0.00|-0.50|0.366
71934197|NCT02092961|143389634|SUPERIORITY_OR_OTHER||Treatment difference|1.25||||0.053|TWO_SIDED|90.0|0.5|2.5||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference \<0 indicates a benefit towards fostamatinib.|24 weeks||2.50|0.50|0.053
71934198|NCT02092961|143389635|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|0.89||||0.006|TWO_SIDED|90.0|0.36|1.41|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||1.41|0.36|0.006
71934199|NCT02092961|143389635|SUPERIORITY_OR_OTHER||Least Square Mean Treatment Difference|-0.34||||0.496|TWO_SIDED|90.0|-1.16|0.49|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.||0.49|-1.16|0.496
71934200|NCT01663714|143389688|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with unconfirmed response.|||100|100|
71934201|NCT01663714|143389689|SUPERIORITY_OR_OTHER||percentage of participants|100.0|||||TWO_SIDED|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with confirmed response.|||100|100|
71934202|NCT00597584|143389710|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.078|||TWO_SIDED|95.0|-0.05|0.26|||ANOVA|The ANOVA cell means model was used to estimate primary efficacy endpoint within the specified cells formed by the combination of treatment and strata||The sample size for this study has been determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.||0.26|-0.05|
71934203|NCT00597584|143389711|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79|||||TWO_SIDED|95.0|0.5|1.24|||Cochran-Mantel-Haenszel|||||1.24|0.50|
71934204|NCT00597584|143389712|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96|||||TWO_SIDED|95.0|0.87|1.07|||Cochran-Mantel-Haenszel|||||1.07|0.87|
71934205|NCT00660790|143389713|OTHER|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||The paired student's t-test or the Wilcoxon signed-rank test was used to compare the measurements before and after multifactorial treatment, as appropriate, depending on the distribution of the data.||||0.021
71934206|NCT03840811|143389715|OTHER|||||||0.23|||||||Sign test|||To assess whether the fitness of a given mutant is different than that of wild-type, the ratio of colony-forming units of the mutant strain was compared to those of the WT strain at the time of treatment and in the inoculum using a Wilcoxon Signed-Rank Test with a significance level of 0.025. CIs of participants in Mixed FA1090 + FA7537 group were compared to mean = 1.||||0.230
71934207|NCT03840811|143389716|OTHER||Risk Difference (RD)|-0.14||||0.54|TWO_SIDED|95.0|-0.58|0.34||One-sided Fisher's Exact Test with alpha=0.025|Fisher Exact|||||0.34|-0.58|0.54
71934208|NCT01625845|143389724|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|95.0|||||ANCOVA|||||||.474
71934209|NCT01625845|143389725|SUPERIORITY_OR_OTHER|||||||0.068|TWO_SIDED|95.0|||||ANCOVA|||||||.068
71934210|NCT01625845|143389726|SUPERIORITY_OR_OTHER|||||||0.296|TWO_SIDED|95.0|||||ANCOVA|||||||.296
71934211|NCT01625845|143389727|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED|95.0|||||ANCOVA|||||||.203
71934212|NCT01625845|143389728|SUPERIORITY_OR_OTHER|||||||0.906|TWO_SIDED||||||ANCOVA|||||||.906
71934213|NCT01625845|143389729|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED|95.0|||||ANCOVA|||||||.869
71934214|NCT01625845|143389730|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|95.0|||||ANCOVA|||||||.026
71934215|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.28|<|0.001|TWO_SIDED|95.0|-2.8|-1.7||Month 1|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.7|-2.8|<0.001
71934216|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.7|-1.5||Month 3|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.5|-2.7|<0.001
71934217|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.1|-0.9||Month 6|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-0.9|-2.1|<0.001
71934218|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.31|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 9|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
71934219|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-2.2|-1.0||Month 12|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.2|<0.001
71934220|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.3|-1.0||Month 15|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.3|<0.001
71934221|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.35|<|0.001|TWO_SIDED|95.0|-2.4|-1.0||Month 18|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.0|-2.4|<0.001
71934222|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 21|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
71934223|NCT01294592|143389748|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-1.8|STANDARD_ERROR_OF_MEAN|0.34|<|0.001|TWO_SIDED|95.0|-2.5|-1.2||Month 24|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.|||-1.2|-2.5|<0.001
71934224|NCT03549130|143389759|SUPERIORITY||Least Square (LS) mean difference|-0.77||||0.2446|TWO_SIDED|95.0|-2.06|0.53||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.53|-2.06|0.2446
71934225|NCT03549130|143389759|SUPERIORITY||LS mean difference|-1.8||||0.0333|TWO_SIDED|95.0|-3.45|-0.14||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.||-0.14|-3.45|0.0333
71934226|NCT03549130|143389759|SUPERIORITY||LS mean difference|-1.63||||0.0345|TWO_SIDED|95.0|-3.13|-0.12||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.||-0.12|-3.13|0.0345
71934227|NCT03549130|143389759|SUPERIORITY||LS mean difference|-0.71||||0.1711|TWO_SIDED|95.0|-1.72|0.31||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.||0.31|-1.72|0.1711
71934228|NCT03549130|143389760|SUPERIORITY||LS mean difference|-0.47||||0.5063|TWO_SIDED|95.0|-1.85|0.92||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.||0.92|-1.85|0.5063
71934229|NCT03549130|143389760|SUPERIORITY||LS mean difference|-0.97||||0.2496|TWO_SIDED|95.0|-2.64|0.69||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.||0.69|-2.64|0.2496
71934230|NCT03549130|143389760|SUPERIORITY||LS mean difference|-0.71||||0.3325|TWO_SIDED|95.0|-2.16|0.74||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.||0.74|-2.16|0.3325
71934231|NCT03549130|143389760|SUPERIORITY||LS mean difference|-0.81||||0.1088|TWO_SIDED|95.0|-1.81|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.||0.18|-1.81|0.1088
71934232|NCT03549130|143389761|SUPERIORITY||LS mean difference|-0.25||||0.2513|TWO_SIDED|95.0|-0.68|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.68|0.2513
71934233|NCT03549130|143389761|SUPERIORITY||LS mean difference|-0.37||||0.0743|TWO_SIDED|95.0|-0.78|0.04||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.04|-0.78|0.0743
71934234|NCT03549130|143389761|SUPERIORITY||LS mean difference|-0.55||||0.0158|TWO_SIDED|95.0|-0.99|-0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||-0.10|-0.99|0.0158
71934235|NCT03549130|143389761|SUPERIORITY||LS mean difference|-0.47||||0.0489|TWO_SIDED|95.0|-0.94|0.0||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.00|-0.94|0.0489
71934236|NCT03549130|143389762|SUPERIORITY||LS mean difference|-0.19||||0.3034|TWO_SIDED|95.0|-0.57|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.||0.18|-0.57|0.3034
71934237|NCT03549130|143389762|SUPERIORITY||LS mean difference|-0.15||||0.4891|TWO_SIDED|95.0|-0.57|0.27||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.||0.27|-0.57|0.4891
71934238|NCT03549130|143389762|SUPERIORITY||LS mean difference|-0.01||||0.9498|TWO_SIDED|95.0|-0.43|0.4||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.||0.40|-0.43|0.9498
71934239|NCT03549130|143389762|SUPERIORITY||LS mean difference|-0.36||||0.1235|TWO_SIDED|95.0|-0.83|0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.||0.10|-0.83|0.1235
71934240|NCT03549130|143389763|SUPERIORITY|||||||0.8498||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.8498
71934241|NCT03549130|143389763|SUPERIORITY|||||||0.4652||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.4652
71934242|NCT03549130|143389763|SUPERIORITY|||||||0.439||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.4390
71934243|NCT03549130|143389763|SUPERIORITY|||||||0.2997||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.2997
71934244|NCT03549130|143389763|SUPERIORITY|||||||0.1116||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.1116
71934245|NCT03549130|143389763|SUPERIORITY|||||||0.5101||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5101
71934246|NCT03549130|143389763|SUPERIORITY|||||||0.474||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.4740
71934247|NCT03549130|143389763|SUPERIORITY|||||||0.2787||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.2787
71934248|NCT03549130|143389764|SUPERIORITY|||||||0.5958||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.||||0.5958
71934249|NCT03549130|143389764|SUPERIORITY|||||||0.7296||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.||||0.7296
71934250|NCT03549130|143389764|SUPERIORITY|||||||0.7171||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.||||0.7171
71934251|NCT03549130|143389764|SUPERIORITY|||||||0.403||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.||||0.4030
71934252|NCT03549130|143389764|SUPERIORITY|||||||0.4741||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.||||0.4741
71934253|NCT03549130|143389764|SUPERIORITY|||||||0.5591||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.||||0.5591
71934254|NCT03549130|143389764|SUPERIORITY|||||||0.8285||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.||||0.8285
71934255|NCT03549130|143389764|SUPERIORITY|||||||0.3487||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.||||0.3487
71934256|NCT01078623|143389765|SUPERIORITY_OR_OTHER||Least squares mean difference|0.221|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.174|0.268|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.268|0.174|<0.0001
71934257|NCT01078623|143389765|SUPERIORITY_OR_OTHER||Least squares mean difference|0.234|STANDARD_ERROR_OF_MEAN|0.024|<|0.0001|TWO_SIDED|95.0|0.186|0.281|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate||||0.281|0.186|<0.0001
71934258|NCT02186808|143389777|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71934259|NCT01042977|143389801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.0489|<|0.0001|TWO_SIDED|95.0|-0.5|-0.3||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-0.30|-0.50|<0.0001
71934260|NCT01042977|143389802|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.0|||<|0.0001|TWO_SIDED|95.0|4.3|9.8||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||9.8|4.3|<0.0001
71934261|NCT01042977|143389803|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93|STANDARD_ERROR_OF_MEAN|0.1957|<|0.0001|TWO_SIDED|95.0|-2.31|-1.54||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.54|-2.31|<0.0001
71934262|NCT01042977|143389804|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6|STANDARD_ERROR_OF_MEAN|2.149|<|0.0001|TWO_SIDED|95.0|9.4|17.8||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline total body weight and age stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0||17.8|9.4|<0.0001
71934263|NCT01042977|143389805|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71|STANDARD_ERROR_OF_MEAN|0.7977||0.0007|TWO_SIDED|95.0|-4.28|-1.15||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.15|-4.28|0.0007
71934264|NCT01042977|143389806|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.02|STANDARD_ERROR_OF_MEAN|0.7983||0.0002|TWO_SIDED|95.0|-4.59|-1.46||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.46|-4.59|0.0002
71934265|NCT01042977|143389807|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|0.9746||0.0004|TWO_SIDED|95.0|-5.35|-1.53||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0||-1.53|-5.35|0.0004
71934266|NCT04356573|143389815|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71934267|NCT01577537|143389831|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71934268|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.|GMC ratio for anti-1|6.17|||||TWO_SIDED|95.0|5.03|7.58|||ANOVA|||To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||7.58|5.03|
71934269|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.|GMC ratio for anti-4|2.86|||||TWO_SIDED|95.0|2.38|3.45|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||3.45|2.38|
71934270|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.|GMC ratio for anti-5|13.47|||||TWO_SIDED|95.0|10.96|16.55|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||16.55|10.96|
71934271|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.|GMC ratio for anti-6B|28.81|||||TWO_SIDED|95.0|22.54|36.81|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||36.81|22.54|
71934272|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.|GMC ratio for anti-7F|4.75|||||TWO_SIDED|95.0|3.9|5.78|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||5.78|3.9|
71934273|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.|GMC ratio for anti-9V|14.1|||||TWO_SIDED|95.0|11.21|17.75|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||17.75|11.21|
71934274|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.|GMC ratio for anti-14|22.92|||||TWO_SIDED|95.0|17.51|30.0|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||30|17.51|
71934275|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.|GMC ratio for anti-18C|10.01|||||TWO_SIDED|95.0|7.95|12.61|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||12.61|7.95|
71934276|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.|GMC ratio for anti-19F|9.25|||||TWO_SIDED|95.0|7.29|11.74|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||11.74|7.29|
71934277|NCT00950833|143389842|NON_INFERIORITY|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.|GMC ratio for anti-23F|36.52|||||TWO_SIDED|95.0|27.59|48.34|||ANOVA|||To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.||48.34|27.59|
71934278|NCT04132232|143389869|SUPERIORITY|||||||0.06|||||||Chi-squared|||||||0.06
71934279|NCT00368537|143389870|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|0.0||||||95.0|-8.7|8.6|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||8.6|-8.7|
71934280|NCT00368537|143389871|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.2||||||95.0|-9.6|14.0|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|||14.0|-9.6|
71934281|NCT00368537|143389872|NON_INFERIORITY_OR_EQUIVALENCE|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.4||||||95.0|-9.6|14.4|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|Group comparison of eradication + presumed eradication||14.4|-9.6|
71934282|NCT00368537|143389874|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.2||||0.444||95.0|-4.4|2.0|||Fisher Exact|2-sided||Intensive care unit||2.0|-4.4|0.444
71934283|NCT01368276|143389887|SUPERIORITY_OR_OTHER||Treatment Difference|-42.9||||0.2645|TWO_SIDED|||||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||||0.2645
71934284|NCT01368276|143389888|SUPERIORITY_OR_OTHER||Treatment Difference|-1.2||||1|TWO_SIDED|95.0|-57.3|54.9||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF|||54.9|-57.3|1.0000
71934285|NCT02008721|143389916|SUPERIORITY|||||||0.51|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.51
71934286|NCT02008721|143389917|SUPERIORITY|||||||0.82|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size, i.e. an expected mean yearly UMSARS-ME increase of 3,9 under verum treatment compared to 7.8 ± 6.8 (mean ± standard deviation) under Placebo treatment.~We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in motor examination scores on UMSARS between baseline and week 52 between the study groups."||||0.82
71934287|NCT02008721|143389918|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.99
71934288|NCT02008721|143389919|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|||"Power calculation: 80% power, 5% P-level, 50% effect size. We used a linear mixed-effects model to test the primary hypothesis-ie, to compare differences in the change in UMSARS total score between baseline and week 52 between the study groups.~We did a post-hoc power calculation based on the mean change in motor examination scores on UMSARS and SDs in the placebo group of the per-protocol study completer set to test the assumptions of our initial power calculation."||||0.43
71934289|NCT00711867|143389945|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was defined as -0.5 C.|Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.14|||t-test, 2 sided|||H0: Mu\_VH - Mu\_BH \<= -0.5 C.||-0.14|-0.55|
71934290|NCT04133519|143389946|SUPERIORITY||Odds Ratio (OR)|1.16||||0.5352|TWO_SIDED|95.0|0.73|1.84||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel|||P value from Cochran-Mantel-Haenszel testing of H0: OR=1; H1: OR≠1 adjusting for IBS subtype and gender||1.84|0.73|0.5352
71934291|NCT04133519|143389946|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0232|TWO_SIDED|95.0|1.08|2.87|||Cochran-Mantel-Haenszel||Odds ratio reflects the odds of the number of GDH responders being greater than the number of MR responders for abdominal pain intensity.|The final 4 weeks of the on-treatment period (weeks 9-12) was a pre-specified period for analysis of the primary endpoint measure of abdominal pain due to IBS. An abdominal pain intensity responder was defined as a participant whose daily abdominal pain intensity averaged over the last 4 weeks of phase s (weeks 9 through 12) was at least 30% reduced compared with the daily abdominal pain intensity averaged over the 4 weeks of phase 1.||2.87|1.08|0.0232
71934292|NCT04133519|143389946|SUPERIORITY||Odds Ratio (OR)|1.76||||0.0254|TWO_SIDED|95.0|1.07|2.89||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||Odds ratio reflects the odds of GDH being superior to MR.|"Abdominal pain scores were averaged each week on treatment (1-12) and compared with the average baseline abdominal pain score. Participants that recorded a \> 30% decrease in abdominal pain in at least half the weeks on treatment were considered responders.~This analysis was specified in FDA Guidance for Industry, Irritable Bowel Syndrome - Clinical Evaluation of Drugs for Treatment, May 2012. Both the analysis period and the responder threshold (30%) are specified by the FDA Guidance."|Among all subjects, 64.0% reported Adequate Relief and 67.7% reported overall satisfaction with Regulora.|2.89|1.07|0.0254
71934293|NCT04133519|143389947|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.8115|TWO_SIDED|95.0|-0.434|0.554|||ANOVA|||The least square (LS) mean difference between the GDH and MR groups using an analysis of variance (ANOVA) model||0.554|-0.434|0.8115
71934294|NCT04133519|143389948|SUPERIORITY||Mean Difference (Final Values)|0.044||||0.7564|TWO_SIDED|95.0|-0.236|0.325|||ANOVA|||Average abdominal pain frequency at Week 13-16 will be statistically compared between GDH and comparator using an ANOVA model adjusted for gender and IBS subtype. The daily pain frequency measurement was derived from the daily pain intensity measurement. Days where severity was \>0 were considered a day with pain and were recorded as positive. Days with a score of 0 were days without pain. Mean represents the mean number of days in each time period with abdominal pain.||0.325|-0.236|0.7564
71934295|NCT04133519|143389949|SUPERIORITY||Odds Ratio (OR)|1.17||||0.4753|TWO_SIDED|95.0|0.76|1.81||P-value from Cochran-Mantel-Haenszel Test testing H0: OR=1; H1: OR\<\>1 adjusting for IBS subtype and gender|Cochran-Mantel-Haenszel||GDH:MR Relative Risk|A Stool Consistency Responder is defined as a \>=30% improvement in the proportion of Bristol Stool Form Scale (BSFS) scores that fall within Group 2 (normal stools)||1.81|0.76|0.4753
71934296|NCT04133519|143389950|SUPERIORITY||Mean Difference (Final Values)|0.08||||0.6793|TWO_SIDED|95.0|-0.301|0.46|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-C participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||0.460|-0.301|0.6793
71934297|NCT04133519|143389950|SUPERIORITY||Mean Difference (Final Values)|0.173||||0.9468|TWO_SIDED|95.0|-4.904|5.249|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model for IBS-D participants:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random Means are the mean daily number of bowel movements for a 24-hour period."||5.249|-4.904|0.9468
71934298|NCT04133519|143389951|SUPERIORITY||Median Difference (Final Values)|-1.602||||0.5015|TWO_SIDED|95.0|-6.282|3.077|||Mixed Models Analysis|||"The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model:~parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random The unstructured covariance matrix was used to model the within-participant correlation. The model-based least square (LS) means and LS mean differences (GDH minus comparator) and associated 95% CIs for each week and overall were estimated."||3.077|-6.282|0.5015
71934299|NCT04133519|143389952|SUPERIORITY||Mean Difference (Final Values)|4.586||||0.2117|TWO_SIDED|95.0|-2.619|11.79|||Mixed Models Analysis|||"Percent Overall Work Impairment Due to IBS defined as the percent time missed by not showing up for work, plus the percent time missed while working, and calculated as: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]."||11.790|-2.619|0.2117
71934300|NCT04133519|143389953|SUPERIORITY||Mean Difference (Net)|2.372||||0.3676|TWO_SIDED|95.0|-2.793|7.537|||Mixed Models Analysis|||The analysis is based on the mixed model repeated measures (MMRM) analysis of variance model: parameter = treatment + timepoint + treatment\*timepoint + gender + subject error + random||7.537|-2.793|0.3676
71934301|NCT00475852|143389966|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.7||||0.313|TWO_SIDED|95.0|-2.1|0.7|||Cochran-Mantel-Haenszel|Stratified by geographical region.||||0.7|-2.1|0.313
71934302|NCT00475852|143389967|SUPERIORITY_OR_OTHER|||||||0.03|||||||Van Elteren test|Controlled for region.||||||0.030
71934303|NCT00475852|143389968|SUPERIORITY_OR_OTHER|||||||0.007|||||||Van Elteren test|Controlled for region.||||||0.007
71934304|NCT00475852|143389969|SUPERIORITY_OR_OTHER|||||||0.318|||||||Van Elteren test|Controlled for region.||||||0.318
71934305|NCT00475852|143389970|SUPERIORITY_OR_OTHER|||||||0.018|||||||Van Elteren test|Controlled for region.||||||0.018
71934306|NCT00475852|143389971|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.5||||0.295|TWO_SIDED|95.0|-1.5|0.5|||Cochran-Mantel-Haenszel|Controlled for region.||||0.5|-1.5|0.295
71934307|NCT00475852|143389972|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.2|STANDARD_ERROR_OF_MEAN|0.17||0.16|||||||ANOVA|Controlled for region.|This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.|||||0.160
71934308|NCT00475852|143389973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.9||||0.238|TWO_SIDED|95.0|-2.4|0.6|||Cochran-Mantel-Haenszel|Controlled for region.|For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.|||0.6|-2.4|0.238
71934309|NCT00475852|143389977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.109|TWO_SIDED|95.0|0.98|1.21|||Cochran-Mantel-Haenszel|Controlled for region.||||1.21|0.98|0.109
71934310|NCT02273206|143389990|SUPERIORITY|||||||0.2562|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference||||0.2562
71934311|NCT02273206|143389990|SUPERIORITY|||||||0.9795|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference||||0.9795
71934312|NCT02273206|143389990|SUPERIORITY|||||||0.3917|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference||||0.3917
71934313|NCT02273206|143389991|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.346||||0.0677|TWO_SIDED|95.0|0.979|1.851||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline colorectal cancer up to date status, age, and income.|||1.851|0.979|0.0677
71934314|NCT02273206|143389992|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|1.031||||0.8501|TWO_SIDED|95.0|0.753|1.41||Treatment Group (CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline breast cancer up to date status, age, and income|||1.410|0.753|0.8501
71934315|NCT02273206|143389993|SUPERIORITY|Test the coefficient for intervention|Odds Ratio (OR)|0.876||||0.4432|TWO_SIDED|95.0|0.625|1.228||Treatment Group(CCI vs PCM)|Regression, Logistic|p\<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline cervical cancer up to date status, age, and income.|||1.228|0.625|0.4432
71934316|NCT02273206|143389994|SUPERIORITY|||||||0.39|||||||Two-sample t-test|p\<0.05||PHQ9 Intervention Arm Difference between baseline and 12-month follow up||||0.39
71934317|NCT02273206|143389995|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at baseline.||||0.60
71934318|NCT02273206|143389995|SUPERIORITY|||||||0.86|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 6 Months||||0.86
71934319|NCT02273206|143389996|SUPERIORITY|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at Baseline.||||0.60
71934320|NCT02273206|143389996|SUPERIORITY|||||||0.23|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 12 months.||||0.23
71934321|NCT02273206|143389997|SUPERIORITY|||||||0.4483|||||||Chi-squared|p\<0.05||Colorectal Cancer Screening Intervention Arm Difference at 12 Months||||0.4483
71691087|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.42||||0.083|TWO_SIDED|90.0|0.08|2.77|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.77|0.08|0.083
71934322|NCT02273206|143389997|SUPERIORITY|||||||0.1706|||||||Chi-squared|p\<0.05||Cervical Cancer Screening Intervention Arm Difference at 12 Months||||0.1706
71934323|NCT02273206|143389997|SUPERIORITY|||||||0.3568|||||||Chi-squared|p\<0.05||Breast Cancer Screening Intervention Arm Difference at 12 Months||||0.3568
71934324|NCT02273206|143389998|SUPERIORITY|||||||0.85|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at baseline.||||0.85
71934325|NCT02273206|143389998|SUPERIORITY|||||||0.23|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 6 months.||||0.23
71934326|NCT02273206|143389998|SUPERIORITY|||||||0.98|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 12 months.||||0.98
71934327|NCT02273206|143389998|SUPERIORITY|||||||0.57|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at baseline.||||0.57
71934328|NCT02273206|143389998|SUPERIORITY|||||||0.92|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 6 months.||||0.92
71934329|NCT02273206|143389998|SUPERIORITY|||||||0.99|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 12 months.||||0.99
71934330|NCT02273206|143389999|SUPERIORITY|||||||0.2|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at baseline.||||0.20
71934331|NCT02273206|143389999|SUPERIORITY|||||||0.17|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 6 months.||||0.17
71934332|NCT02273206|143389999|SUPERIORITY|||||||0.69|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 12 months.||||0.69
71934333|NCT02273206|143389999|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at baseline.||||0.72
71934334|NCT02273206|143389999|SUPERIORITY|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 6 months.||||0.72
71934335|NCT02273206|143389999|SUPERIORITY|||||||0.87|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 12 months.||||0.87
71934336|NCT02273206|143389999|SUPERIORITY|||||||0.65|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at baseline.||||0.65
71934337|NCT02273206|143389999|SUPERIORITY|||||||0.82|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 6 months.||||0.82
71691088|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.65||||0.002|TWO_SIDED|90.0|1.29|4.01|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.01|1.29|0.002
71934338|NCT02273206|143389999|SUPERIORITY|||||||0.92|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 12 months.||||0.92
71934339|NCT02273206|143389999|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months.||||0.56
71934340|NCT02273206|143390000|SUPERIORITY|||||||0.17|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at baseline.||||0.17
71934341|NCT02273206|143390000|SUPERIORITY|||||||0.38|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 6 months.||||0.38
71691089|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.3||||0.006|TWO_SIDED|90.0|0.94|3.66|||ANCOVA|||Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.66|0.94|0.006
71934342|NCT02273206|143390000|SUPERIORITY|||||||0.07|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 12 months.||||0.07
71934343|NCT02273206|143390000|SUPERIORITY|||||||0.99|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at baseline.||||0.99
71934344|NCT02273206|143390000|SUPERIORITY|||||||0.15|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 6 months.||||0.15
71934345|NCT02273206|143390000|SUPERIORITY|||||||0.55|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 12 months.||||0.55
71934346|NCT02273206|143390000|SUPERIORITY|||||||0.34|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at baseline.||||0.34
71934347|NCT02273206|143390000|SUPERIORITY|||||||0.31|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 6 months. .||||0.31
71934348|NCT02273206|143390000|SUPERIORITY|||||||0.39|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 12 months.||||0.39
71934349|NCT02273206|143390000|SUPERIORITY|||||||0.87|||||||Chi-squared|||Physician Recommendation of Mental Health Care at baseline.||||0.87
71934350|NCT02273206|143390000|SUPERIORITY|||||||0.83|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 6 months.||||0.83
71934351|NCT02273206|143390000|SUPERIORITY|||||||0.36|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 12 months.||||0.36
71934352|NCT02273206|143390001|SUPERIORITY|||||||0.95|||||||Chi-squared|||Generalized Anxiety Disorder scale at baseline. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.95
71934353|NCT02273206|143390001|SUPERIORITY|||||||0.08|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 6 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.08
71934354|NCT02273206|143390001|SUPERIORITY|||||||0.27|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 12 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., \& Lowe, B. (2006).||||0.27
71934355|NCT02273206|143390002|SUPERIORITY|||||||0.54|||||||Chi-squared|||Medical Outcomes Study Health Survey at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.54
71934356|NCT02273206|143390002|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
71934357|NCT02273206|143390002|SUPERIORITY|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.68
71934358|NCT02273206|143390003|SUPERIORITY|||||||0.74|||||||Chi-squared|||Colorectal Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.74
71934359|NCT02273206|143390003|SUPERIORITY|||||||0.86|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.86
71934360|NCT02273206|143390003|SUPERIORITY|||||||0.79|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.79
71934361|NCT02273206|143390003|SUPERIORITY|||||||0.91|||||||Chi-squared|||Breast Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
71934362|NCT02273206|143390003|SUPERIORITY|||||||0.71|||||||Chi-squared|||Breast Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.71
71934363|NCT02273206|143390003|SUPERIORITY|||||||0.77|||||||Chi-squared|||Breast Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.77
71934364|NCT02273206|143390003|SUPERIORITY|||||||0.64|||||||Chi-squared|||Cervical Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.64
71934365|NCT02273206|143390003|SUPERIORITY|||||||0.11|||||||Chi-squared|||Cervical Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.11
71934366|NCT02273206|143390003|SUPERIORITY|||||||1|||||||Chi-squared|||Cervical Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||1.00
71934367|NCT02273206|143390005|SUPERIORITY|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months. Recoding of the continuous measure was based on quartiles.||||0.56
71934368|NCT02273206|143390006|SUPERIORITY|||||||0.18|||||||Chi-squared|||Devaluation-Discrimination Scale Score at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.18
71934369|NCT02273206|143390006|SUPERIORITY|||||||0.32|||||||Chi-squared|||Devaluation-Discrimination Scale score at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.32
71934370|NCT02273206|143390007|SUPERIORITY|||||||0.5|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.50
71934371|NCT02273206|143390007|SUPERIORITY|||||||0.51|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.51
71934372|NCT02273206|143390007|SUPERIORITY|||||||0.02|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.02
71934373|NCT02273206|143390007|SUPERIORITY|||||||0.91|||||||Chi-squared|||Ambulatory Care Experiences - Access at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.91
71934374|NCT02273206|143390007|SUPERIORITY|||||||0.69|||||||Chi-squared|||Ambulatory Care Experiences - Access at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.69
71934375|NCT02273206|143390007|SUPERIORITY|||||||0.63|||||||Chi-squared|||Ambulatory Care Experiences - Access at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.63
71934376|NCT02273206|143390007|SUPERIORITY|||||||0.55|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.55
71934377|NCT02273206|143390007|SUPERIORITY|||||||0.34|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.34
71934378|NCT02273206|143390007|SUPERIORITY|||||||0.19|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.19
71934379|NCT02273206|143390007|SUPERIORITY|||||||0.47|||||||Chi-squared|||Ambulatory Care Experiences - Quality at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.47
71934380|NCT02273206|143390007|SUPERIORITY|||||||0.38|||||||Chi-squared|||Ambulatory Care Experiences - Quality at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.38
71934381|NCT02273206|143390007|SUPERIORITY|||||||0.98|||||||Chi-squared|||Ambulatory Care Experiences - Quality at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.98
71934382|NCT02273206|143390008|SUPERIORITY|||||||0.78|||||||Chi-squared|||Medication Adherence at baseline. Coding of the measure was based on Morisky et al. (2008).||||0.78
71934383|NCT02273206|143390008|SUPERIORITY|||||||0.2|||||||Chi-squared|||Medication Adherence at 6 months. Coding of the measure was based on Morisky et al. (2008).||||0.20
71934384|NCT02273206|143390008|SUPERIORITY|||||||0.77|||||||Chi-squared|||Medication Adherence at 12 Months. Coding of the measure was based on Morisky et al. (2008).||||0.77
71934385|NCT02273206|143390009|SUPERIORITY|||||||0.7|||||||Chi-squared|||Self-efficacy at baseline.Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.70
71934386|NCT02273206|143390009|SUPERIORITY|||||||0.89|||||||Chi-squared|||Self-efficacy at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.89
71934387|NCT02273206|143390009|SUPERIORITY|||||||0.95|||||||Chi-squared|||Self-efficacy at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.||||0.95
71934388|NCT00373685|143390011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|TWO_SIDED|||||Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test|Life Table Extension of CMH Test|||||||0.0003
71934389|NCT00373685|143390012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0035|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.0035
71934390|NCT00373685|143390013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.614|TWO_SIDED||||||Life Table Extension of CMH Test|||||||0.6140
71934391|NCT00373685|143390015|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
71934392|NCT00373685|143390017|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED|||||P-value associated with Overall (LOCF)|ANCOVA|||||||<0.0001
71934393|NCT00373685|143390018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0023|TWO_SIDED|||||P-value associated with Overall (LOCF)|Cochran-Mantel-Haenszel|||||||0.0023
71934394|NCT00373685|143390019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1008|TWO_SIDED||||||Chi-squared|||Baseline||||0.1008
71934395|NCT00373685|143390019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71934396|NCT00373685|143390019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71934397|NCT00373685|143390019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0005|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0005
71934398|NCT00373685|143390019|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||<0.0001
71934399|NCT00373685|143390020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6562|TWO_SIDED||||||Chi-squared|||Baseline||||0.6562
71934400|NCT00373685|143390020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71934401|NCT00373685|143390020|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71934402|NCT00373685|143390020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0245|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0245
71934403|NCT00373685|143390020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0074|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0074
71934404|NCT00373685|143390021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4074|TWO_SIDED||||||Chi-squared|||Baseline||||0.4074
71934405|NCT00373685|143390021|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71934406|NCT00373685|143390021|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71934407|NCT00373685|143390021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0127|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0127
71934408|NCT00373685|143390021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0019|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0019
71934409|NCT00373685|143390022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2699|TWO_SIDED||||||Chi-squared|||Baseline||||0.2699
71934410|NCT00373685|143390022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 8||||<0.0001
71934411|NCT00373685|143390022|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Chi-squared|||Week 16||||<0.0001
71934412|NCT00373685|143390022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0027|TWO_SIDED||||||Chi-squared|||Week 24 or ET||||0.0027
71934413|NCT00373685|143390022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Chi-squared|||Week 24/LOCF||||0.0001
71934414|NCT01890785|143390028|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.708|||||TWO_SIDED|90.0|0.655|0.766||||||||0.766|0.655|
71934415|NCT01890785|143390028|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.918|||||TWO_SIDED|90.0|0.849|0.992||||||||0.992|0.849|
71934416|NCT01890785|143390029|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.641|||||TWO_SIDED|90.0|0.582|0.707||||||||0.707|0.582|
71934417|NCT01890785|143390029|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.828|||||TWO_SIDED|90.0|0.752|0.912||||||||0.912|0.752|
71934418|NCT01890785|143390030|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.937|1.004||||||||1.004|0.937|
71934419|NCT01890785|143390030|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.944|||||TWO_SIDED|90.0|0.912|0.977||||||||0.977|0.912|
71934420|NCT01890785|143390031|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.971|||||TWO_SIDED|90.0|0.945|0.998||||||||0.998|0.945|
71934421|NCT01890785|143390031|SUPERIORITY_OR_OTHER_LEGACY||Ratio of geometric least squares means|0.97|||||TWO_SIDED|90.0|0.944|0.997||||||||0.997|0.944|
71934422|NCT02191579|143390073|SUPERIORITY||Odds Ratio (OR)|4.94|||<|0.001|TWO_SIDED|95.0|2.681|9.085||Odds ratio, 95% CI, and p-value were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||9.085|2.681|<0.001
71934423|NCT02191579|143390074|SUPERIORITY||Mean Difference (Net)|-6.199|||<|0.001|TWO_SIDED|95.0|-7.936|-4.462||Estimated mean difference, 95% CI, and p-value were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-4.462|-7.936|<0.001
71934424|NCT02191579|143390075|SUPERIORITY||Median Difference (Net)|-4.248|||<|0.001||95.0|-5.766|-2.731||Estimated mean difference, 95% CI, and p-value for Week 30 were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA|||||-2.731|-5.766|<0.001
71934425|NCT02191579|143390076|SUPERIORITY||Odds Ratio (OR)|4.05|||<|0.001||95.0|2.014|8.157||Odds ratio, 95% CI, and p-value for the Week 29-32 interval were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic|||||8.157|2.014|<0.001
71934426|NCT00769015|143390077|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.54||||0.067|TWO_SIDED|95.0|0.27|1.06||Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.|Mantel Haenszel|||||1.06|.27|.067
71934427|NCT00769015|143390078|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.75|TWO_SIDED|95.0|-5.92|4.3|||Linear Mixed effects model|||||4.30|-5.92|.75
71934428|NCT00769015|143390079|SUPERIORITY_OR_OTHER||Change in least squares mean|3.47||||0.68|TWO_SIDED|95.0|-12.22|5.29|||Mixed Models Analysis|||||5.29|-12.22|.68
71934429|NCT00769015|143390080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.42||||0.34|TWO_SIDED|95.0|-2.58|7.41|||Least squares mean|||||7.41|-2.58|.34
71934430|NCT00769015|143390081|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.68|TWO_SIDED|95.0|-9.8|5.76|||Least squares mean|||||5.76|-9.80|.68
71934431|NCT00769015|143390082|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39||||0.68|TWO_SIDED|95.0|-4.04|6.82|||Least squares mean|||||6.82|-4.04|.68
71934432|NCT00769015|143390083|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.62||||0.68|TWO_SIDED|95.0|-5.94|9.17|||Least squares mean|||||9.17|-5.94|.68
71934433|NCT04288115|143390188|NON_INFERIORITY|An one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|-5.3||||0.0913|TWO_SIDED|90.0|-16.1|5.4||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Hypothyroid Symptoms score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||5.4|-16.1|0.0913
71934434|NCT04288115|143390188|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical difference.|Difference in Group Means|0.8||||0.8793|TWO_SIDED|95.0|-9.4|10.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates the real discontinuation mean and the sham discontinuation mean are different. Adjusted for gender and baseline HSSs.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-week outcome||10.9|-9.4|0.8793
71934435|NCT04288115|143390188|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-2.3||||0.686|TWO_SIDED|95.0|-14.0|9.3||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline HSS.|Differences are reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline hypothyroid symptom scores.|Analysis of 6-month outcome||9.3|-14.0|0.6860
71934436|NCT04288115|143390189|NON_INFERIORITY|A one-sided α-level of 0.05 will be used to determine the statistical significance of the non-inferiority test.|Difference in Group Means|5.2||||0.0036|TWO_SIDED|90.0|-6.2|16.6||Group differences.|Welch's two-sample t-test|A one-sided p-value \< 0.05 indicates the discontinuation mean falls within the non-inferiority limit.|Differences reported as the sham discontinuation mean minus the real discontinuation mean.|A one-sided t-test will be used to determine whether the mean Tiredness score for the real discontinuation group is no more than 14 points worse than the score of the sham discontinuation group at 6 months.||16.6|-6.2|0.0036
71934437|NCT04288115|143390189|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|2.3||||0.7104|TWO_SIDED|95.0|-10.1|14.7||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These mean differences have been adjusted for gender and baseline tiredness score.|Analysis of 6-week outcome||14.7|-10.1|0.7104
71934438|NCT04288115|143390189|OTHER|A two-sided α-level of 0.05 will be used to determine statistical significance.|Difference in Group Means|5.4||||0.3381|TWO_SIDED|95.0|-5.9|16.7||Group differences.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as sham discontinuation mean minus real discontinuation mean. These differences have been adjusted for gender and baseline tiredness scores.|Analysis of 6-month outcome||16.7|-5.9|0.3381
71934439|NCT04288115|143390190|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-0.02||||0.4684|TWO_SIDED|95.0|-0.076|0.036||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-week EQ-5D Descriptive score outcome.||0.036|-0.076|0.4684
71934440|NCT04288115|143390190|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|0.003||||0.9585|TWO_SIDED|95.0|-0.102|0.107||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D Descriptive scores.|Analysis of 6-month EQ-5D Descriptive score outcome.||0.107|-0.102|0.9585
71934441|NCT04288115|143390190|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|7.0||||0.0643|TWO_SIDED|95.0|-0.4|14.4||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline score.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-week EQ-5D VAS score outcome.||14.4|-0.4|0.0643
71691090|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.49||||0.533|TWO_SIDED|90.0|-0.8|1.78|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.78|-0.80|0.533
71934442|NCT04288115|143390190|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.2||||0.1742|TWO_SIDED|95.0|-15.3|2.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline scores.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline EQ-5D VAS scores.|Analysis of 6-month EQ-5D VAS score outcome.||2.9|-15.3|0.1742
71934443|NCT04288115|143390191|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-12.0||||0.1695|TWO_SIDED|95.0|-29.3|5.3||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline total cholesterol value.|Analysis of 6-month total cholesterol outcome.||5.3|-29.3|0.1695
71934444|NCT04288115|143390191|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-6.8||||0.3805|TWO_SIDED|95.0|-22.2|8.6||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline LDL values.|Analysis of 6-month LDL outcome.||8.6|-22.2|0.3805
71934445|NCT04288115|143390191|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|1.7||||0.5724|TWO_SIDED|95.0|-4.44|7.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline HDL values.|Analysis of 6-month HDL outcome.||7.9|-4.44|0.5724
71934446|NCT04288115|143390191|OTHER|A two-sided α-level of 0.05 will be used to determine the statistical significance.|Difference in Group Means|-17.8||||0.3939|TWO_SIDED|95.0|-59.4|23.9||Testing whether group means are different.|ANCOVA|A p-value \< 0.05 indicates real discontinuation mean and sham discontinuation mean are different. Analyses adjusted for gender and baseline value.|Differences reported as the sham discontinuation mean minus the real discontinuation mean. These differences have been adjusted for gender and baseline triglyceride values.|Analysis of 6-month triglyceride outcome.||23.9|-59.4|0.3939
71934447|NCT02270983|143390214|SUPERIORITY||Least squares mean difference|1.325|STANDARD_ERROR_OF_MEAN|0.45||0.0035|TWO_SIDED|95.0|0.439|2.211|||ANCOVA|||||2.211|0.439|0.0035
71934448|NCT02270983|143390214|SUPERIORITY||Least squares mean difference|1.908|STANDARD_ERROR_OF_MEAN|0.451|<|0.0001|TWO_SIDED|95.0|1.021|2.796|||ANCOVA|||||2.796|1.021|<0.0001
71934449|NCT02270983|143390215|SUPERIORITY||Cox Proportional Hazard|1.28||||0.1429|TWO_SIDED|95.0|0.92|1.77|||Log Rank|||||1.77|0.92|0.1429
71934450|NCT02270983|143390215|SUPERIORITY||Cox Proportional Hazard|1.43||||0.0287|TWO_SIDED|95.0|1.04|1.97|||Log Rank|||||1.97|1.04|0.0287
71934451|NCT02270983|143390216|SUPERIORITY||Odds Ratio (OR)|1.37||||0.3332|TWO_SIDED|95.0|0.73|2.58|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||2.58|0.73|0.3332
71934452|NCT02270983|143390216|SUPERIORITY||Odds Ratio (OR)|1.92||||0.0506|TWO_SIDED|95.0|1.0|3.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.||||3.68|1.00|0.0506
71934453|NCT02270983|143390217|SUPERIORITY||Least squares mean difference|0.751|STANDARD_ERROR_OF_MEAN|0.217||0.0007|TWO_SIDED|95.0|0.324|1.178|||ANCOVA|||||1.178|0.324|0.0007
71934454|NCT02270983|143390217|SUPERIORITY||Least squares mean difference|0.987|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|0.558|1.416|||ANCOVA|||||1.416|0.558|<0.0001
71934455|NCT02270983|143390218|SUPERIORITY||Least squares mean difference|-0.46|STANDARD_ERROR_OF_MEAN|0.145||0.0017|TWO_SIDED|95.0|-0.746|-0.174|||ANCOVA|||||-0.174|-0.746|0.0017
71934456|NCT02270983|143390218|SUPERIORITY||Least squares mean difference|-0.669|STANDARD_ERROR_OF_MEAN|0.146|<|0.0001|TWO_SIDED|95.0|-0.957|-0.382|||ANCOVA|||||-0.382|-0.957|<0.0001
71934457|NCT02270983|143390219|SUPERIORITY||Least squares mean difference|0.033|STANDARD_ERROR_OF_MEAN|0.205||0.872|TWO_SIDED|95.0|-0.371|0.437|||ANCOVA|||||0.437|-0.371|0.8720
71934458|NCT02270983|143390219|SUPERIORITY||Least squares mean difference|-0.607|STANDARD_ERROR_OF_MEAN|0.205||0.0034|TWO_SIDED|95.0|-1.011|-0.203|||ANCOVA|||||-0.203|-1.011|0.0034
71934459|NCT00740727|143390256|SUPERIORITY_OR_OTHER||% of subjects with infusion pain|11.1||||||95.0|1.4|34.7|||95% binomial exact confidence interval|||This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.||34.7|1.4|
71934460|NCT00740727|143390257|SUPERIORITY_OR_OTHER||% subjects with next-day EASI site pain|0.0||||||97.5|0.0|18.5|||binomial exact confidence interval|Because the point estimate was zero, the statistical software (STATA version 10MP) reports a one-sided 97.5% confidence interval.||This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.||18.5|0|
71934461|NCT04364165|143390258|SUPERIORITY||Odds Ratio (OR)|2.0||||0.01|TWO_SIDED|95.0|1.44|2.78|||Regression, Logistic|||||2.78|1.44|.01
71934462|NCT04364165|143390259|SUPERIORITY||Odds Ratio (OR)|1.44||||0.41|TWO_SIDED|95.0|0.36|5.78|||Regression, Logistic|||||5.78|0.36|.41
71934463|NCT01473758|143390297|SUPERIORITY_OR_OTHER||LS Mean Difference|1.404|STANDARD_ERROR_OF_MEAN|3.07||0.6491|TWO_SIDED|95.0|-4.731|7.538||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||7.538|-4.731|0.6491
71934464|NCT01473758|143390298|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.412|STANDARD_ERROR_OF_MEAN|2.687||0.8786|TWO_SIDED|95.0|-5.766|4.943||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA|||||4.943|-5.766|0.8786
71934465|NCT01677910|143390355|SUPERIORITY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.283|-0.337|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.337|-1.283|< 0.001
71934466|NCT01677910|143390355|SUPERIORITY||Mean Difference (Net)|-0.833|||<|0.001|TWO_SIDED|95.0|-1.292|-0.374|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.||-0.374|-1.292|< 0.001
71934467|NCT03341273|143390366|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-6.0|||||TWO_SIDED|95.0|-15.0|2.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D5V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D5V is 5.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||2|-15|
71934468|NCT03341273|143390367|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-4.0|||||TWO_SIDED|95.0|-12.0|3.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D11V is 11.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||3|-12|
71934469|NCT03341273|143390368|NON_INFERIORITY|The non-inferiority margin is 12.5%. Non-inferiority of placebo is concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement is greater than -12.5%.|Risk Difference (RD)|-7.0|||||TWO_SIDED|95.0|-13.0|0.0||The null hypothesis was evaluated using a non-inferiority test and non-inferiority of placebo was concluded if the lower limit of the 95% confidence interval for the difference in proportions of clinical improvement was greater than -12.5%.|||Multiple imputation with a linear model to impute missing clinical values of improvement. The study day that D11V occurred on was included as a covariate in the final model and the estimates for risk difference assume that study day of D28V is 28.|Null Hypothesis: Proportion in placebo - Proportion in azithromycin = -12.5%||0|-13|
71934470|NCT03341273|143390369|SUPERIORITY|DOOR is a composite endpoint created using clinical outcomes from Day 1 through Day 5 Visit. It is based on adequate clinical improvement at Day 5 Visit and solicited events from Day 1 through Day 5 Visit.|Pr(Higher DOOR in Placebo at Day 5 Visit|0.63|||<|0.001|TWO_SIDED|95.0|0.57|0.68||Missing DOOR values at Day 5 Visit were first imputed using linear regression using baseline covariates and available DOOR components as covariates.|Wilcoxon (Mann-Whitney)|The Mann-Whitney test was run on the multiple imputed datasets to generate estimates of DOOR probability and p-value||Null: The sum of the probability that a participant assigned to placebo will have a higher DOOR at Day 5 visit than if assigned to the Azithromycin plus one-half the probability of equal DOORs at Day 5 Visit is 50% (i.e., no difference in DOOR at Day 5 Visit).||0.68|0.57|<0.001
71934471|NCT01717456|143390393|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_DEVIATION|6.72||0.05|TWO_SIDED|95.0||||No adjustment for multiple comparisons.|t-test, 2 sided|||||||.05
71934472|NCT03751020|143390425|SUPERIORITY||Mean Difference (Net)|-6.34|||<|0.01|TWO_SIDED|95.0|-11.03|-1.64|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-1.64|-11.03|<0.01
71934473|NCT03751020|143390426|SUPERIORITY||Mean Difference (Net)|-0.33||||0.03|TWO_SIDED|95.0|-0.62|-0.03|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||-0.03|-0.62|0.03
71934474|NCT03751020|143390427|SUPERIORITY||Mean Difference (Net)|-4.03||||0.07|TWO_SIDED|95.0|-8.55|0.47|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.47|-8.55|0.07
71934475|NCT03751020|143390428|SUPERIORITY||Mean Difference (Net)|1.12||||0.73|TWO_SIDED|95.0|-6.48|8.77|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||8.77|-6.48|0.73
71934476|NCT03751020|143390429|SUPERIORITY||Mean Difference (Net)|-1.28||||0.1|TWO_SIDED|95.0|-2.8|0.24|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||0.24|-2.80|0.10
71934477|NCT03751020|143390430|SUPERIORITY||Mean Difference (Net)|0.09||||0.76|TWO_SIDED|95.0|-1.19|1.57|||Mixed Models Analysis|||The primary comparison was between EW and control to test the interaction between treatment and time.||1.57|-1.19|0.76
71934478|NCT00033631|143390455|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.83|1.2||Two-sided test, significance level = 0.05|Log Rank||Reference level = 70.2 Gy arm|The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.||1.2|0.83|0.98
71934479|NCT00033631|143390456|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.59|||<|0.0001|TWO_SIDED|95.0|0.5|0.7||Two-sided significance level = 0.05|Gray's test|Reference arm is 70.2 Gy arm||||0.70|0.50|<0.0001
71934480|NCT00033631|143390457|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.66||||0.14|TWO_SIDED|95.0|0.38|1.15|||Gray's test|Two-sided significance level = 0.05|Reference level is 70.2 Gy arm|||1.15|0.38|0.14
71934481|NCT00033631|143390458|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.41||||0.0001|TWO_SIDED|95.0|0.25|0.66|||Gray's test|Two-sided significance level = 0.05|Reference level = 70.2 Gy arm|||0.66|0.25|0.0001
71934482|NCT00033631|143390459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65||||0.051|TWO_SIDED|95.0|0.42|1.01||Two-sided significance level = 0.05|Gray's test||Reference level is the 70.2 Gy level|||1.01|0.42|0.051
71934483|NCT00033631|143390460|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||Two-sided significance level = 0.05|Chi-squared|||||||0.29
71934484|NCT00033631|143390461|SUPERIORITY|||||||0.0513|||||||Chi-squared|Two-sided significance level = 0.05||With an expected percentage of erectile disfunction (ED) at 12 months of 29%, a two-sided significance level of 0.05, and 688 patients per arm provides 90% statistical power to detect a reduction in ED to 19%. This calculation assumes 26% ED at baseline and 80% compliance at 12 months. Only participants with baseline ED are analyzed.||||0.0513
71934485|NCT00033631|143390462|SUPERIORITY|||||||0.59|||||||Chi-squared|Two-sided significance level = 0.05||||||0.59
71934486|NCT00528879|143390466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1014||0.0002||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||0.0002
71934487|NCT00528879|143390466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41|STANDARD_ERROR_OF_MEAN|0.1016|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
71934488|NCT00528879|143390466|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.54|STANDARD_ERROR_OF_MEAN|0.1021|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA|||||||<0.0001
71934489|NCT00528879|143390467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.8|STANDARD_ERROR_OF_MEAN|3.774|<|0.0019||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0019
71934490|NCT00528879|143390467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.5|STANDARD_ERROR_OF_MEAN|3.781|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934491|NCT00528879|143390467|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.5|STANDARD_ERROR_OF_MEAN|3.819|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934492|NCT00528879|143390468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934493|NCT00528879|143390468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16|STANDARD_ERROR_OF_MEAN|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934494|NCT00528879|143390468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97|STANDARD_ERROR_OF_MEAN|0.3365|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934495|NCT00528879|143390469|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|7.1||||0.1775||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.1775
71934496|NCT00528879|143390469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7||||0.0275||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0275
71934497|NCT00528879|143390469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7||||0.0062||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0062
71934498|NCT00528879|143390470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.3515||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71934499|NCT00528879|143390470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.3022||0.0068||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0068
71934500|NCT00528879|143390470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|0.3535||0.029||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0290
71934501|NCT00528879|143390471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.3681||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71934502|NCT00528879|143390471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|0.3745|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934503|NCT00528879|143390471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.08|STANDARD_ERROR_OF_MEAN|0.3791|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934504|NCT00528879|143390478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.1109||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71934505|NCT00528879|143390478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1129||0.0004||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||0.0004
71934506|NCT00528879|143390478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.1146|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934507|NCT00528879|143390479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|2.769||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|ANCOVA|||||||
71934508|NCT00528879|143390479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.1|STANDARD_ERROR_OF_MEAN|2.762|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934509|NCT00528879|143390479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.7|STANDARD_ERROR_OF_MEAN|2.808|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|ANCOVA|||||||<0.0001
71934510|NCT00528879|143390480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9||||||||||Sequential testing procedures were used, and no test was performed for this comparison due to the fact that the previous comparison was not significant.|Modified logistic regression|||||||
71934511|NCT00528879|143390480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.8627|||||||Modified logistic regression|||||||0.8627
71934512|NCT00528879|143390480|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.3||||0.0149||||||Statistically significant according to hierarchical testing procedure (p\<0.05).|Modified logistic regression|||||||0.0149
71934513|NCT00078819|143390481|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71934514|NCT00078819|143390482|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71934515|NCT00078819|143390483|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71934516|NCT00078819|143390484|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Van Elteren test|Two-sided van Elteren's test stratified by age group||||||<0.0001
71934517|NCT00078819|143390485|SUPERIORITY|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group||||||<0.0001
71934518|NCT00323609|143390488|SUPERIORITY_OR_OTHER|||||||0.214||95.0|||||Fisher Exact|||||||0.214
71934519|NCT00323609|143390489|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 7 days.||||0.430
71934520|NCT00323609|143390489|SUPERIORITY_OR_OTHER|||||||0.655||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.655
71934521|NCT00323609|143390489|SUPERIORITY_OR_OTHER|||||||0.756||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.756
71934522|NCT00323609|143390489|SUPERIORITY_OR_OTHER|||||||0.503||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.503
71934523|NCT00323609|143390489|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.837
71934524|NCT00323609|143390490|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days||||0.785
71934525|NCT00323609|143390490|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.393
71934526|NCT00323609|143390490|SUPERIORITY_OR_OTHER|||||||0.875||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months||||0.875
71934527|NCT00323609|143390490|SUPERIORITY_OR_OTHER|||||||0.833||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.833
71934528|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 30 days.||||0.180
71934529|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.822||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 3 months||||0.822
71934530|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.291||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 12 months||||0.291
71934531|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.996||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 24 months||||0.996
71934532|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.983||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 30 days||||0.983
71934533|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.576||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 3 months||||0.576
71934534|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 12 months||||0.393
71934535|NCT00323609|143390491|SUPERIORITY_OR_OTHER|||||||0.722||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 24 months||||0.722
71934536|NCT00323609|143390492|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.||||0.318
71934537|NCT00323609|143390492|SUPERIORITY_OR_OTHER|||||||0.523||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.523
71934538|NCT00323609|143390492|SUPERIORITY_OR_OTHER|||||||0.634||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.634
71934539|NCT00323609|143390492|SUPERIORITY_OR_OTHER|||||||0.457||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.457
71934540|NCT00323609|143390493|SUPERIORITY_OR_OTHER|||||||0.818||95.0|||||Fisher Exact|||||||0.818
71934541|NCT00323609|143390494|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||Fisher Exact|||||||0.226
71934542|NCT00323609|143390495|SUPERIORITY_OR_OTHER|||||||1||95.0|||||Fisher Exact|||||||1.0
71934543|NCT00323609|143390496|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.112
71934544|NCT00323609|143390496|SUPERIORITY_OR_OTHER|||||||0.364||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.364
71934545|NCT00323609|143390496|SUPERIORITY_OR_OTHER|||||||0.185||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.185
71934546|NCT00323609|143390496|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.100
71934547|NCT00323609|143390497|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.005
71934548|NCT00323609|143390497|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.382
71934549|NCT00323609|143390497|SUPERIORITY_OR_OTHER|||||||0.196||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.196
71934550|NCT00323609|143390497|SUPERIORITY_OR_OTHER|||||||0.281||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.281
71934551|NCT00323609|143390498|SUPERIORITY_OR_OTHER|||||||0.033||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.033
71934552|NCT00323609|143390498|SUPERIORITY_OR_OTHER|||||||0.981||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.981
71934553|NCT00323609|143390498|SUPERIORITY_OR_OTHER|||||||0.631||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.631
71934554|NCT00323609|143390498|SUPERIORITY_OR_OTHER|||||||0.79||95.0||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.790
71934555|NCT00323609|143390499|SUPERIORITY_OR_OTHER|||||||0.663||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.663
71934556|NCT00323609|143390499|SUPERIORITY_OR_OTHER|||||||0.933||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.933
71934557|NCT00323609|143390499|SUPERIORITY_OR_OTHER|||||||0.089||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.089
71934558|NCT00323609|143390499|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.036
71934559|NCT00323609|143390500|SUPERIORITY_OR_OTHER|||||||0.472||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.||||0.472
71934560|NCT00323609|143390500|SUPERIORITY_OR_OTHER|||||||0.745||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.||||0.745
71934561|NCT00323609|143390500|SUPERIORITY_OR_OTHER|||||||0.565||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.||||0.565
71934562|NCT00323609|143390500|SUPERIORITY_OR_OTHER|||||||0.687||95.0||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.||||0.687
71934563|NCT00267293|143390505|NON_INFERIORITY_OR_EQUIVALENCE|Power for 80%|||||<|0.001||||||comparision of mean temperatures from repeated exposure. At hour 6 temperature|Mixed Models Analysis|||Power for 80%||||<0.001
71934564|NCT00267293|143390505|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Binary outcome \<38C and \>=38C|Chi-squared|||||||<.0001
71934565|NCT00950599|143390506|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||A significance level of alpha = 0.05 was used for the trend test.|Kruskal-Wallis|ANCOVA Model: post-pre=pre treatment.||A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.||||0.9888
71934566|NCT00950599|143390507|SUPERIORITY_OR_OTHER|||||||0.9888||95.0||||Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.|ANCOVA|ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.||||||0.9888
71934567|NCT01684722|143390608|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.25|TWO_SIDED|95.0|-0.7|2.5|||Mixed Models Analysis|||||2.5|-0.7|0.25
71934568|NCT01684722|143390608|SUPERIORITY||Mean Difference (Final Values)|0.9||||0.27|TWO_SIDED|95.0|-0.7|2.6|||Mixed Models Analysis|||||2.6|-0.7|0.27
71934569|NCT01684722|143390609|SUPERIORITY||Ratio of change from baseline, active to|0.99||||0.9|TWO_SIDED|95.0|0.84|1.17|||Mixed Models Analysis|||||1.17|0.84|0.90
71934570|NCT01684722|143390609|SUPERIORITY||Ratio of change from baseline, active to|0.96||||0.64|TWO_SIDED|95.0|0.81|1.14|||Mixed Models Analysis|||||1.14|0.81|0.64
71934571|NCT03063632|143390618|OTHER|||||||||||||||||Per Global Response Score used in Mycosis Fungoides and Sezary Syndrome, Response is assessed by the standard response criteria: Complete Response (CR), complete disappearance of all clinical evidence of disease where all categories (i.e., skin, lymph nodes, viscera, blood) have complete response/noninvolved; Partial Response (PR), regression of measurable disease; Stable Disease (SD), failure to attain CR, PR, or PD.|Simple statistics. Non-responders excluded from analysis.|||
71934572|NCT03063632|143390619|OTHER||||||||||||||||||Kaplan-Meier method|||
71934573|NCT03063632|143390620|OTHER|||||||||||||||||Progression is assessed by the standard response criteria used in Mycosis Fungoides and Sezary Syndrome (skin, lymph nodes, viscera, blood, global). Per Global Response Score, progression is defined as Progressive Disease (PD) in any category (i.e., skin, lymph nodes, viscera, blood).|Kaplan-Meier method|||
71934574|NCT03063632|143390621|OTHER||||||||||||||||||Kaplan-Meier method|||
71934575|NCT03063632|143390622|OTHER||||||||||||||||||Binomial distribution|||
71934576|NCT02570165|143390626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|191.1|||||TWO_SIDED|95.0|101.07|284.26|||||The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.|||284.26|101.07|
71934577|NCT02570165|143390626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|231.6|||||TWO_SIDED|95.0|149.31|310.02|||||The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.|||310.02|149.31|
71934578|NCT02570165|143390626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|261.8|||||TWO_SIDED|95.0|189.85|332.25|||||The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.|||332.25|189.85|
71934579|NCT02570165|143390626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|281.4|||||TWO_SIDED|95.0|212.35|351.3|||||The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.|||351.30|212.35|
71934580|NCT02570165|143390626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|292.8|||||TWO_SIDED|95.0|223.02|364.42|||||The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.|||364.42|223.02|
71934581|NCT02570165|143390627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|182.2|||||TWO_SIDED|95.0|99.8|264.6|||||The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.|||264.60|99.80|
71934582|NCT02570165|143390627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|196.6|||||TWO_SIDED|95.0|128.4|264.8|||||The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.|||264.80|128.40|
71934583|NCT02570165|143390627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|204.6|||||TWO_SIDED|95.0|137.2|272.1|||||The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.|||272.10|137.20|
71934584|NCT02570165|143390627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|208.9|||||TWO_SIDED|95.0|138.7|279.2|||||The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.|||279.20|138.70|
71934585|NCT02570165|143390627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|211.1|||||TWO_SIDED|95.0|138.6|283.7|||||The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.|||283.70|138.60|
71934586|NCT00362401|143390639|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||ANOVA|||The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.||||<0.05
71934587|NCT05478603|143390655|OTHER||Ratio of adjusted geometric means|94.88|||||TWO_SIDED|90.0|70.86|127.04|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||127.04|70.86|
71934588|NCT05478603|143390655|OTHER||Ratio of adjusted geometric means|99.75|||||TWO_SIDED|90.0|74.5|133.56|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||133.56|74.50|
71934589|NCT05478603|143390655|OTHER||Ratio of adjusted geometric means|68.7|||||TWO_SIDED|90.0|51.31|91.98|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||91.98|51.31|
71934590|NCT05478603|143390656|OTHER||Ratio of adjusted geometric means|101.87|||||TWO_SIDED|90.0|59.74|173.71|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||173.71|59.74|
71934591|NCT05478603|143390656|OTHER||Ratio of adjusted geometric means|156.07|||||TWO_SIDED|90.0|91.53|266.14|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||266.14|91.53|
71934592|NCT05478603|143390656|OTHER||Ratio of adjusted geometric means|96.48|||||TWO_SIDED|90.0|56.58|164.51|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||164.51|56.58|
71934593|NCT05478603|143390657|OTHER||Ratio of adjusted geometric means|102.21|||||TWO_SIDED|90.0|59.91|174.39|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||174.39|59.91|
71934594|NCT05478603|143390657|OTHER||Ratio of adjusted geometric means|152.91|||||TWO_SIDED|90.0|89.62|260.9|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||260.90|89.62|
71934595|NCT05478603|143390657|OTHER||Ratio of adjusted geometric means|97.08|||||TWO_SIDED|90.0|56.9|165.65|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||165.65|56.90|
71934596|NCT05478603|143390658|OTHER||Ratio of adjusted geometric means|93.29|||||TWO_SIDED|90.0|64.61|134.69|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||134.69|64.61|
71934597|NCT05478603|143390658|OTHER||Ratio of adjusted geometric means|106.68|||||TWO_SIDED|90.0|73.89|154.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||154.03|73.89|
71934598|NCT05478603|143390658|OTHER||Ratio of adjusted geometric means|246.28|||||TWO_SIDED|90.0|170.57|355.58|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||355.58|170.57|
71934599|NCT05478603|143390659|OTHER||Ratio of adjusted geometric means|88.5|||||TWO_SIDED|90.0|64.13|122.12|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||122.12|64.13|
71934600|NCT05478603|143390659|OTHER||Ratio of adjusted geometric means|106.4|||||TWO_SIDED|90.0|77.11|146.83|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||146.83|77.11|
71934601|NCT05478603|143390659|OTHER||Ratio of adjusted geometric means|169.19|||||TWO_SIDED|90.0|122.61|233.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||233.47|122.61|
71934602|NCT05478603|143390660|OTHER||Ratio of adjusted geometric means|95.12|||||TWO_SIDED|90.0|52.6|172.03|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.03|52.60|
71934603|NCT05478603|143390660|OTHER||Ratio of adjusted geometric means|166.77|||||TWO_SIDED|90.0|92.21|301.62|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||301.62|92.21|
71934604|NCT05478603|143390660|OTHER||Ratio of adjusted geometric means|237.76|||||TWO_SIDED|90.0|131.46|430.0|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||430.00|131.46|
71934605|NCT05478603|143390661|OTHER||Ratio of adjusted geometric means|95.34|||||TWO_SIDED|90.0|52.67|172.59|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||172.59|52.67|
71934606|NCT05478603|143390661|OTHER||Ratio of adjusted geometric means|163.09|||||TWO_SIDED|90.0|90.1|295.22|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||295.22|90.10|
71934607|NCT05478603|143390661|OTHER||Ratio of adjusted geometric means|239.47|||||TWO_SIDED|90.0|132.29|433.47|||ANOVA||The ratio and 90% CI are expressed as percentages.|"One-way ANOVA was used on the natural log transformed PK parameters with hepatic function group as a fixed factor.~The adjusted mean differences and the corresponding 90% confidence intervals derived from ANOVA were exponentiated to provide estimate of the ratio of adjusted geometric means (Test \[hepatic impairment group\]/Reference \[without hepatic impairment group\]) and 90% confidence intervals for the ratio."||433.47|132.29|
71934608|NCT03182686|143390681|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||"H0:π ≤ π0 versus HA:π \> π0~Where π0 is the hypothesized clinically significant value for the proportion of responders. The value will be 30% in this study. This test will be tested using an exact binomial test. That is, given the sample size of n, the number of responders X, and the value of π0 =0.30, then probability that X or more events would be observed will be calculated as the p-value. Since this is a one-sided test, the alpha level will be 0.025."||||<0.0001
71934609|NCT00529568|143390727|SUPERIORITY_OR_OTHER||Percentage difference in SVR|6.0||||0.0202|TWO_SIDED|95.0|1.2|10.9||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.|||10.9|1.2|0.0202
71934610|NCT00931385|143390750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.183|0.113|<0.0001
71934611|NCT00931385|143390750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.148|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.183|0.113|<0.0001
71934612|NCT00931385|143390750|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.106|0.177|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.177|0.106|<0.0001
71934613|NCT00931385|143390751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.109|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.073|0.146|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.146|0.073|<0.0001
71934614|NCT00931385|143390751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.127|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.091|0.164|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.164|0.091|<0.0001
71934615|NCT00931385|143390751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.209|0.135|<0.0001
71934616|NCT00931385|143390752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.094|0.163|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.163|0.094|<0.0001
71934617|NCT00931385|143390752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.137|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.103|0.172|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.172|0.103|<0.0001
71934618|NCT00931385|143390752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.122|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.191|0.122|<0.0001
71934619|NCT00931385|143390753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.126|0.201|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.201|0.126|<0.0001
71934620|NCT00931385|143390753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.127|0.202|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.202|0.127|<0.0001
71934621|NCT00931385|143390753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.198|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.16|0.236|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.236|0.160|<0.0001
71934622|NCT00931385|143390754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.174|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.135|0.214|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.214|0.135|<0.0001
71934623|NCT00931385|143390754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.127|0.206|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.206|0.127|<0.0001
71934624|NCT00931385|143390754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.02|<|0.0001||95.0|0.178|0.257|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.257|0.178|<0.0001
71934625|NCT00931385|143390755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.106|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.064|0.147|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.147|0.064|<0.0001
71934626|NCT00931385|143390755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.072|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.155|0.072|<0.0001
71934627|NCT00931385|143390755|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001||95.0|0.092|0.175|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.175|0.092|<0.0001
71934628|NCT00931385|143390756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.167|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.284|0.167|<0.0001
71934629|NCT00931385|143390756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.229|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.17|0.287|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.287|0.170|<0.0001
71934630|NCT00931385|143390756|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.203|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.144|0.262|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.262|0.144|<0.0001
71934631|NCT00931385|143390757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.087|0.207|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.207|0.087|<0.0001
71934632|NCT00931385|143390757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.112|0.231|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.231|0.112|<0.0001
71934633|NCT00931385|143390757|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001||95.0|0.191|0.311|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.311|0.191|<0.0001
71934634|NCT00931385|143390758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.132|0.241|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.241|0.132|<0.0001
71934635|NCT00931385|143390758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.145|0.254|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.254|0.145|<0.0001
71934636|NCT00931385|143390758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.227|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001||95.0|0.172|0.282|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.282|0.172|<0.0001
71934637|NCT00931385|143390759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.261|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.191|0.33|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.330|0.191|<0.0001
71934638|NCT00931385|143390759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.252|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.183|0.322|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.322|0.183|<0.0001
71934639|NCT00931385|143390759|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.302|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.232|0.372|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.372|0.232|<0.0001
71934640|NCT00931385|143390760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.087|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo|||0.221|0.087|<0.0001
71934641|NCT00931385|143390760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.154|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.086|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo|||0.221|0.086|<0.0001
71934642|NCT00931385|143390760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.115|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo|||0.250|0.115|<0.0001
71934643|NCT01364259|143390806|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.175|TWO_SIDED||||||Fisher Exact||Our odds ratio is equal to 0\*5/9\*2 because we have a zero cell in the two by two table. Hence the OR = 0.|||||0.175
71934644|NCT04444752|143390819|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gate-keeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared to placebo group in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical signficance at p=0.05 level was not achieved.|Mean Difference (Final Values)|23.36|STANDARD_ERROR_OF_MEAN|6.794||0.0007|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg dose Q2W 3. 300 mg dose Q4W vs placebo|ANCOVA|The data were analyzed using an ANCOVA model adjusted for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The primary efficacy analysis includes comparison of percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q2W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0007
71934645|NCT04444752|143390819|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with the placebo group in order from the highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at 0.05 level was not achieved.|Mean Difference (Final Values)|17.89|STANDARD_ERROR_OF_MEAN|6.537||0.0067|TWO_SIDED|||||Adjusted for multiplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were analyzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI.||"The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 150 Q2W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0067
71934646|NCT04444752|143390819|SUPERIORITY|Pairwise comparisons for each CBP-201 group vs placebo were performed and a serial gatekeeping procedure was used for multiplicity adjustment. Each CBP-201 group was compared with placebo in order from highest dose (300 mg Q2W) to the lowest dose frequency (300 mg Q4W), until statistical significance at the 0.05 level was not achieved.|Mean Difference (Final Values)|23.83|STANDARD_ERROR_OF_MEAN|6.575||0.0004|TWO_SIDED|||||Adjusted for mulitplicity using a serial gatekeeping procedure at the 5% in descending order: 1. 300 mg dose Q2W 2. 150 mg Q2W 3. 300 mg Q4W vs placebo.|ANCOVA|The data were anlayzed using an ANCOVA model with terms for treatment, baseline vIGA (moderate, severe), and baseline EASI||"The efficacy analysis includes comparing percentage reduction in EASI from baseline to Week 16 for CBP-201 300 mg Q4W regimen vs placebo.~The sample size of the study was determined based on power calculations for the primary endpoint in patients receiving CBP-201 300 mg Q2W.~Null hypothesis: CBP-201 300 Q4W is not superior to placebo in terms of percent reduction in EASI Score from Baseline to Week 16."||||0.0004
71934647|NCT04444752|143390820|SUPERIORITY|The secondary efficacy analysis includes comparison of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16 for each CBP-201 300 mg Q2W vs placebo.|Difference in vIGA Response Rate|28.1||||0.0089|TWO_SIDED|||||There were no adjustments for multiple comparisons. For IGA response, counts, percentage, and 95% CIs obtained using the Clopper-Pearson method and were presented for pairwise comparisons for each CBP-201 group vs. placebo.|Chi-squared|||Null hypothesis: CBP-201 300 Q2W is not superior to placebo in terms of the number of patients achieving a vIGA score of 0/1 (clear/almost clear) at Week 16.||||0.0089
71934648|NCT00185211|143390821|SUPERIORITY_OR_OTHER|||||||0.0027||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to CDMS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to CDMS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.0027
71934649|NCT00185211|143390821|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.663||||0.0028||97.47|0.488|0.902|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to CDMS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for CDMS, i.e. hazard ratio = 1.||0.902|0.488|0.0028
71934650|NCT00185211|143390822|SUPERIORITY_OR_OTHER|||||||0.1768||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was: H0: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are not identical for both treatment arms for some points in time t\>0. The two-sided alternative hypothesis was: H1: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are identical for both treatment arms for some points in time t\>0.||||0.1768
71934651|NCT00185211|143390822|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.764||||0.1604||97.47|0.497|1.174|||Regression, Cox|The variable used as additional covariate adjustment was volume of T2 lesions on screening MRI.|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to confirmed EDSS progression was modelled by a Cox proportional hazards regression model with the following covariates: treatment group and volume of T2 lesions on screening MRI. The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for confirmed EDSS progression, i.e. hazard ratio = 1.||1.174|0.497|0.1604
71934652|NCT00185211|143390823|SUPERIORITY_OR_OTHER|||||||0.888||95.0||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|non-parametric ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a non-parametric analysis of covariance (ANCOVA)."||||0.8880
71934653|NCT00185211|143390823|SUPERIORITY_OR_OTHER|||||||0.3832||95.0|||||ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||"The null hypothesis H0: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms was tested against the alternative hypothesis HA: The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms using a parametric analysis of covariance (ANCOVA)."||||0.3832
71934654|NCT00185211|143390824|SUPERIORITY_OR_OTHER|||||||6e-06||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are identical for both treatment arms for all points in time t\>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are not identical for both treatment arms for some points in time t\>0."||||0.000006
71934655|NCT00185211|143390824|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.583|||<|1e-06||95.0|0.474|0.718|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b versus initial placebo, i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to McDonald MS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for McDonald MS, i.e. hazard ratio = 1.||0.718|0.474|< 0.000001
71934656|NCT00185211|143390825|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.1265||95.0|0.595|1.066||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Andersen-Gill Model|Covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|The time to recurrent relapses was modelled by an extension of Cox's PH regression model (Andersen-Gill Model) for recurrent events with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for recurrent relapses, i.e. hazard ratio = 1.||1.066|0.595|0.1265
71934657|NCT00185211|143390826|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7971||||0.0141||95.0|0.665|0.9554||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear Poisson regression|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Risk Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Relapse rate was analyzed by a generalized linear Poisson regression model with individual relapse counts as dependent variable, covariates: treatment arm, steroid use during first event, onset of disease and categorized number of T2 lesions at screening and offset variable natural log of time (in years) as difference between last clinical visit and baseline visit. The treatment effect on the relapse rate was of primary interest.||0.9554|0.6650|0.0141
71934658|NCT00185211|143390827|SUPERIORITY_OR_OTHER|||||||0.6078||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is identical for both treatment arms was tested against the alternative hypothesis HA: The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.6078
71934659|NCT00185211|143390827|SUPERIORITY_OR_OTHER|||||||0.8245||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||"The null hypothesis H0: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are identical for both treatment arms was tested against the alternative hypothesis HA: The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are not the same in the two treatment groups based on a non-parametric analysis of covariance (ANCOVA)."||||0.8245
71934660|NCT00185211|143390828|SUPERIORITY_OR_OTHER|||||||0.0062||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: number of Gd-enhancing lesions on T1 at screening||"The null hypothesis H0: The distribution of the cumulative number of newly active lesions at month 60 adjusted for the number of Gadolinium (Gd)-enhancing lesions on T1 at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.0062
71934661|NCT00185211|143390828|SUPERIORITY_OR_OTHER||Relative effect size|0.7351||||0.0435||95.0|0.5436|0.994||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear model|Distribution: negative binomial distribution; covariate: number of Gd-enhancing lesions on T1 at screening|The direction of comparison is initial IFNB-1b versus initial placebo.|Assuming that the cumulative number of newly active lesions at month 60 follows a negative binomial distribution, a generalized linear model (logarithmic link function, covariate: number of Gd-enhancing lesions on T1 at BENEFIT screening) was set up in order to analyze the treatment effect on that MRI outcome.||0.9940|0.5436|0.0435
71934662|NCT00185211|143390829|SUPERIORITY_OR_OTHER|||||||0.7801||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The distribution of the absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.7801
71934663|NCT00185211|143390829|SUPERIORITY_OR_OTHER|||||||0.9408||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: T2 lesion volume at screening||"The null hypothesis H0: The mean absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.9408
71934664|NCT00185211|143390830|SUPERIORITY_OR_OTHER|||||||0.6619||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The distribution of the absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.6619
71934665|NCT00185211|143390830|SUPERIORITY_OR_OTHER|||||||0.8558||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Volume of black holes at screening||"The null hypothesis H0: The mean absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.8558
71934666|NCT00185211|143390831|SUPERIORITY_OR_OTHER|||||||0.1208||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The distribution of the percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA)."||||0.1208
71934667|NCT00185211|143390831|SUPERIORITY_OR_OTHER|||||||0.0719||95.0||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Brain volume at screening||"The null hypothesis H0: The mean percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms. was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA)."||||0.0719
71934668|NCT02544633|143390836|SUPERIORITY|An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR \<=20% against H1: ORR \>20%.|Objective response rate|10.7||||0.94|TWO_SIDED|95.0|2.27|28.23|||exact test|||||28.23|2.27|0.94
71934669|NCT02544633|143390836|SUPERIORITY||Objective response rate|15.0||||0.79|TWO_SIDED|95.0|3.21|37.89|||exact test|||||37.89|3.21|0.79
71934670|NCT02544633|143390836|SUPERIORITY||Objective response rate|25.0||||0.47|TWO_SIDED|95.0|3.19|65.09|||Exact Test|||||65.09|3.19|0.47
71934671|NCT02544633|143390836|SUPERIORITY||Objective response rate|0.0|||>|0.999|TWO_SIDED|95.0|0.0|26.46|||Exact test|||||26.46|0.00|>0.999
71934672|NCT02257632|143390861|SUPERIORITY||Mean Difference (Final Values)|-14.98|||<|0.0001|TWO_SIDED|95.0|-19.64|-10.32||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all other patients|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-10.32|-19.64|<0.0001
71934673|NCT02257632|143390862|SUPERIORITY||Mean Difference (Final Values)|-11.46|||<|0.0001|TWO_SIDED|95.0|-15.98|-6.94||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all the patients with values|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate||||-6.94|-15.98|< 0.0001
71934674|NCT00936884|143390884|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|83.6|||<|0.0001|TWO_SIDED|97.5|6.5|1074.7||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after the first injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||1074.7|6.50|<0.0001
71934675|NCT00936884|143390885|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|56.64|||<|0.0001|TWO_SIDED|97.5|40.62|72.66||Comparison of the MNTX group and the placebo group was based on ANOVA model with the proportion of injections resulting in RFBM within 4 hours during the double-blind period as the dependent variable and the treatment group as the fixed effect. .|ANOVA||Estimated value is the difference in least squared means for MNTX vs. placebo (MNTX minus placebo). Based on the ANOVA model, there is 97.5% confidence that the difference between MNTX and placebo falls between the lower and upper limits presented.|||72.66|40.62|<0.0001
71934676|NCT00936884|143390886|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|23.38|||<|0.0001|TWO_SIDED|97.5|10.91|50.14||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after each injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared|||||50.14|10.91|< 0.0001
71934677|NCT01859390|143390920|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.46|TWO_SIDED|95.0|-0.49|0.22|||t-test, 2 sided|||Two-sample T-test||0.22|-0.49|0.460
71934678|NCT01859390|143390920|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.325|TWO_SIDED|95.0|-0.513|0.173|||Regression, Linear||"Regression Model predictors include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1%Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The estimated value is the mean difference between groups for 16 week change in log10 MPO."|||0.173|-0.513|0.325
71934679|NCT01859390|143390921|SUPERIORITY||Difference in Proportions-SAE incidence|-12.9||||0.302|TWO_SIDED|95.0|-32.1|7.8|||Fisher Exact|||||7.8|-32.1|0.302
71934680|NCT01859390|143390922|SUPERIORITY||Rate Ratio|0.94||||0.486|TWO_SIDED|95.0|0.78|1.13|||Poisson Model|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.||1.13|0.78|0.486
71934681|NCT01859390|143390922|SUPERIORITY|Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|Rate Ratio|0.74||||0.269|TWO_SIDED|95.0|0.43|1.26|||Poisson Regression|||||1.26|0.43|0.269
71934682|NCT01859390|143390923|SUPERIORITY|Two sample T-test|Median Difference (Final Values)|1.43||||0.4463|TWO_SIDED|95.0|-2.3|5.16|||t-test, 2 sided|||||5.16|-2.30|0.4463
71934683|NCT01859390|143390924|SUPERIORITY||Median Difference (Final Values)|0.04||||0.8623|TWO_SIDED|95.0|-0.37|0.44|||t-test, 2 sided|||||0.44|-0.37|0.8623
71934684|NCT01859390|143390925|SUPERIORITY||Cox Proportional Hazard|0.536||||0.0534|TWO_SIDED|95.0|0.284|1.009||Not adjusted for multiple comparisons. Alpha at 0.05.|Regression, Cox||"Cox model parameters include: AquADEKs-2 arm, Age \>=18 years, Sex, Screening FEV1 % Predicted \>70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm."|||1.009|0.284|0.0534
71934685|NCT01859390|143390926|SUPERIORITY||Rate Ratio|0.72||||0.1731|TWO_SIDED|95.0|0.44|1.16|||Poisson Model|||Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.||1.16|0.44|0.1731
71934686|NCT01859390|143390927|SUPERIORITY|Difference in Proportions|Mean Difference (Final Values)|-14.8||||0.2363|TWO_SIDED|95.0|-35.1|7.4||Not adjusted for multiple comparisons. Alpha at 0.05.|Fisher Exact|||||7.4|-35.1|0.2363
71934687|NCT01859390|143390928|SUPERIORITY|Difference in Proportions|Median Difference (Final Values)|-15.7||||0.19|TWO_SIDED|95.0|-34.5|4.8|||Fisher Exact|||||4.8|-34.5|0.1900
71934688|NCT01706198|143390956|OTHER||Adjusted Odds Ratio|2.0|||<|0.001|TWO_SIDED|95.0|1.7|2.34||The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care has been presented.|||2.34|1.70|<0.001
71934689|NCT01706198|143390957|OTHER||Adjusted Odds Ratio|1.92|||<|0.001|TWO_SIDED|95.0|1.67|2.2||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.|||2.20|1.67|<0.001
71934690|NCT01706198|143390957|OTHER||Adjusted Odds Ratio|1.66|||<|0.001|TWO_SIDED|95.0|1.45|1.91||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.|||1.91|1.45|<0.001
71934691|NCT01706198|143390957|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.54|2.02||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.|||2.02|1.54|<0.001
71934692|NCT01706198|143390958|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.82|2.4||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.40|1.82|<0.001
71934693|NCT01706198|143390958|OTHER||Adjusted Odds Ratio|1.96|||<|0.001|TWO_SIDED|95.0|1.7|2.25||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.25|1.70|<0.001
71934694|NCT01706198|143390958|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.56|2.06||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.06|1.56|<0.001
71934695|NCT01706198|143390958|OTHER||Adjusted Odds Ratio|1.95|||<|0.001|TWO_SIDED|95.0|1.69|2.24||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.24|1.69|<0.001
71934696|NCT01706198|143390959|OTHER||Adjusted Odds Ratio|2.28|||<|0.001|TWO_SIDED|95.0|1.98|2.62||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.|||2.62|1.98|<0.001
71934697|NCT01706198|143390959|OTHER||Adjusted Odds Ratio|2.09|||<|0.001|TWO_SIDED|95.0|1.81|2.41||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.|||2.41|1.81|<0.001
71934698|NCT01706198|143390959|OTHER||Adjusted Odds Ratio|1.76|||<|0.001|TWO_SIDED|95.0|1.53|2.02||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.|||2.02|1.53|<0.001
71934699|NCT01706198|143390959|OTHER||Adjusted Odds Ratio|1.91|||<|0.001|TWO_SIDED|95.0|1.66|2.21||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.|||2.21|1.66|<0.001
71934700|NCT01706198|143390960|OTHER||Mean Difference (Net)|1.54|||<|0.001|TWO_SIDED|95.0|1.3|1.77||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|Mixed Model Repeated Measures (MMRM)||Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.|||1.77|1.30|<0.001
71934701|NCT01706198|143390960|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.25|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.|||1.76|1.25|<0.001
71934702|NCT01706198|143390960|OTHER||Mean Difference (Net)|1.37|||<|0.001|TWO_SIDED|95.0|1.11|1.63||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.|||1.63|1.11|<0.001
71934703|NCT01706198|143390960|OTHER||Mean Difference (Net)|1.5|||<|0.001|TWO_SIDED|95.0|1.24|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.|||1.76|1.24|<0.001
71934704|NCT01706198|143390962|OTHER||Ratio|1.03||||0.786|TWO_SIDED|95.0|0.83|1.28||GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.28|0.83|0.786
71934705|NCT01706198|143390963|OTHER||Ratio|1.02||||0.461|TWO_SIDED|95.0|0.97|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.97|0.461
71934706|NCT01706198|143390965|OTHER||Ratio|0.99||||0.822|TWO_SIDED|95.0|0.91|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.08|0.91|0.822
71934707|NCT01706198|143390966|OTHER||Ratio|1.1|||<|0.001|TWO_SIDED|95.0|1.05|1.15||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.15|1.05|<0.001
71934708|NCT01706198|143390968|OTHER||Ratio|0.98||||0.697|TWO_SIDED|95.0|0.88|1.09||GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender \& age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.|||1.09|0.88|0.697
71934709|NCT01706198|143390969|OTHER||Hazard Ratio (HR)|0.96||||0.504|TWO_SIDED|95.0|0.86|1.07||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||A hazard ratio \<1 indicated a lower risk with FF/VI compared with Usual Care|||1.07|0.86|0.504
71934710|NCT01706198|143390970|OTHER||Mean Difference (Final Values)|-0.8|||<|0.001|TWO_SIDED|95.0|-1.1|-0.5||ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age \& number of salbutamol inhalers in year prior to randomization|ANCOVA||Difference of FF/VI versus Usual Care has been presented.|||-0.5|-1.1|<0.001
71934711|NCT01706198|143390971|OTHER||Hazard Ratio (HR)|1.23|||<|0.001|TWO_SIDED|95.0|1.09|1.38||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented|||1.38|1.09|<0.001
71934712|NCT01706198|143390972|OTHER||Adjusted Odds Ratio|1.79|||<|0.001|TWO_SIDED|95.0|1.55|2.06||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI with Usual Care has been presented.|||2.06|1.55|<0.001
71934713|NCT01706198|143390973|OTHER||Adjusted Odds Ratio|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.73||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI versus Usual Care has been presented.|||1.73|1.31|<0.001
71934714|NCT01706198|143390974|NON_INFERIORITY|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.4|||||TWO_SIDED|95.0|0.8|2.7|||||Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.|||2.7|0.8|
71934715|NCT01706198|143390975|OTHER||Hazard Ratio (HR)|1.45||||0.255|TWO_SIDED|95.0|0.77|2.74||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented.|||2.74|0.77|0.255
71934716|NCT04229303|143390995|OTHER||Slope|0.62|||<|0.0001|TWO_SIDED|90.0|0.424|0.821|||General power constant model|||Statistics for Voriconazole AUC0-t||0.821|0.424|<0.0001
71934717|NCT04229303|143390995|OTHER||Slope|1.21||||0.0363|TWO_SIDED|90.0|1.05|1.362|||General power linear model|||Statistics for Voriconazole AUC0-t||1.362|1.050|0.0363
71934718|NCT04229303|143390995|OTHER||Geometric mean difference|13.48|||<|0.0001|TWO_SIDED|90.0|10.096|17.994|||ANOVA|||Statistics for Voriconazole AUC0-t, 40mg vs 5mg||17.994|10.096|<0.0001
71934719|NCT04229303|143390995|OTHER||Slope|1.85|||<|0.0001|TWO_SIDED|90.0|1.728|1.963|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-t||1.963|1.728|<0.0001
71934720|NCT04229303|143390995|OTHER||Slope|0.87||||0.0201|TWO_SIDED|90.0|0.789|0.96|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-t||0.960|0.789|0.0201
71934721|NCT04229303|143390995|OTHER||Geometric mean difference|6.16|||<|0.0001|TWO_SIDED|90.0|5.253|7.217|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t, 40mg vs 5mg||7.217|5.253|<0.0001
71934722|NCT04229303|143390995|OTHER||Slope|0.81|||<|0.0001|TWO_SIDED|90.0|0.661|0.958|||General power constant model|||Statistics for Voriconazole AUC0-inf||0.958|0.661|<0.0001
71934723|NCT04229303|143390995|OTHER||Slope|1.12||||0.1278|TWO_SIDED|90.0|0.99|1.245|||General power linear model|||Statistics for Voriconazole AUC0-inf||1.245|0.990|0.1278
71934724|NCT04229303|143390995|OTHER||Geometric mean difference|9.43|||<|0.0001|TWO_SIDED|90.0|6.834|13.012|||ANOVA|||Statistics for Voriconazole AUC0-inf, 40mg vs 5mg||13.012|6.834|<0.0001
71934725|NCT04229303|143390995|OTHER||Slope|1.98|||<|0.0001|TWO_SIDED|90.0|1.86|2.106|||General power constant model|||Statistics for N-oxide Voriconazole AUC0-inf||2.106|1.860|<0.0001
71934726|NCT04229303|143390995|OTHER||Slope|0.79||||0.0082|TWO_SIDED|90.0|0.67|0.912|||General power linear model|||Statistics for N-oxide Voriconazole AUC0-inf||0.912|0.670|0.0082
71934727|NCT04229303|143390995|OTHER||Geometric mean difference|5.86|||<|0.0001|TWO_SIDED|90.0|4.627|7.421|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf, 40mg vs 5mg||7.421|4.627|<0.0001
71934728|NCT04229303|143390996|OTHER||Slope|0.12||||0.2575|TWO_SIDED|90.0|-0.06|0.308|||General power constant model|||Statistics for Voriconazole Cmax||0.308|-0.060|0.2575
71934729|NCT04229303|143390996|OTHER||Slope|1.17||||0.0491|TWO_SIDED|90.0|1.03|1.316|||General power linear model|||Statistics for Voriconazole Cmax||1.316|1.030|0.0491
71934730|NCT04229303|143390996|OTHER||Geometric mean difference|11.17|||<|0.0001|TWO_SIDED|90.0|8.435|14.803|||ANOVA|||Statistics for Voriconazole Cmax, 40mg vs 5mg||14.803|8.435|<0.0001
71934731|NCT04229303|143390996|OTHER||Slope|1.25|||<|0.0001|TWO_SIDED|90.0|1.135|1.363|||General power constant model|||Statistics for N-oxide Voriconazole Cmax||1.363|1.135|<0.0001
71934732|NCT04229303|143390996|OTHER||Slope|0.74||||0.0003|TWO_SIDED|90.0|0.634|0.843|||General power linear model|||Statistics for N-oxide Voriconazole Cmax||0.843|0.634|0.0003
71934733|NCT04229303|143390996|OTHER||Geometric mean difference|4.97|||<|0.0001|TWO_SIDED|90.0|3.946|6.254|||ANOVA|||Statistics for N-oxide Voriconazole Cmax, 40mg vs 5mg||6.254|3.946|<0.0001
71934734|NCT04229303|143391003|OTHER||Slope|2.0||||0.0004|TWO_SIDED|90.0|1.528|2.617|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||2.617|1.528|0.0004
71934735|NCT04229303|143391003|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.612|6.187|||ANOVA|||Statistics for Voriconazole AUC0-t Day 1||6.187|3.612|<0.0001
71934736|NCT04229303|143391003|OTHER||Slope|2.81|||<|0.0001|TWO_SIDED|90.0|2.017|3.925|||ANOVA|||Statistics for Voriconazole AUC0-t day 10||3.925|2.017|<0.0001
71934737|NCT04229303|143391003|OTHER||Slope|5.28|||<|0.0001|TWO_SIDED|90.0|3.783|7.361|||ANOVA|||Statistics for Voriconazole AUC0-t Day 10||7.361|3.783|<0.0001
71934738|NCT04229303|143391003|OTHER||Slope|1.97|||<|0.0001|TWO_SIDED|90.0|1.615|2.396|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||2.396|1.615|<0.0001
71934739|NCT04229303|143391003|OTHER||Slope|5.09|||<|0.0001|TWO_SIDED|90.0|4.178|6.196|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 1||6.196|4.178|<0.0001
71934740|NCT04229303|143391003|OTHER||Slope|2.45||||0.0002|TWO_SIDED|90.0|1.791|3.349|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||3.349|1.791|0.0002
71934741|NCT04229303|143391003|OTHER||Slope|4.6|||<|0.0001|TWO_SIDED|90.0|3.365|6.294|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-t Day 10||6.294|3.365|<0.0001
71934742|NCT04229303|143391003|OTHER||Slope|1.99||||0.0005|TWO_SIDED|90.0|1.524|2.602|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||2.602|1.524|0.0005
71934743|NCT04229303|143391003|OTHER||Slope|4.58|||<|0.0001|TWO_SIDED|90.0|3.505|5.984|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 1||5.984|3.505|<0.0001
71934744|NCT04229303|143391003|OTHER||Slope|2.65||||0.0003|TWO_SIDED|90.0|1.851|3.781|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||3.781|1.851|0.0003
71934745|NCT04229303|143391003|OTHER||Slope|5.04|||<|0.0001|TWO_SIDED|90.0|3.587|7.088|||ANOVA|||Statistics for Voriconazole AUC0-inf Day 10||7.088|3.587|<0.0001
71934746|NCT04229303|143391003|OTHER||Slope|1.93|||<|0.0001|TWO_SIDED|90.0|1.569|2.384|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||2.384|1.569|<0.0001
71934747|NCT04229303|143391003|OTHER||Slope|4.56|||<|0.0001|TWO_SIDED|90.0|3.608|5.759|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 1||5.759|3.608|<0.0001
71934748|NCT04229303|143391003|OTHER||Slope|2.4||||0.0007|TWO_SIDED|90.0|1.694|3.402|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||3.402|1.694|0.0007
71934749|NCT04229303|143391003|OTHER||Slope|4.22|||<|0.0001|TWO_SIDED|90.0|2.975|5.974|||ANOVA|||Statistics for N-oxide Voriconazole AUC0-inf Day 10||5.974|2.975|<0.0001
71934750|NCT04229303|143391004|OTHER||Slope|2.03||||0.0003|TWO_SIDED|90.0|1.562|2.65|||ANOVA|||Statistics for Voriconazole Cmax Day 1||2.650|1.562|0.0003
71934751|NCT04229303|143391004|OTHER||Slope|4.87|||<|0.0001|TWO_SIDED|90.0|3.74|6.345|||ANOVA|||Statistics for Voriconazole Cmax Day 1||6.345|3.740|<0.0001
71934752|NCT04229303|143391004|OTHER||Slope|2.67|||<|0.0001|TWO_SIDED|90.0|2.081|3.429|||ANOVA|||Statistics for Voriconazole Cmax Day 10||3.429|2.081|<0.0001
71934753|NCT04229303|143391004|OTHER||Slope|5.97|||<|0.0001|TWO_SIDED|90.0|4.647|7.658|||ANOVA|||Statistics for Voriconazole Cmax Day 10||7.658|4.647|<0.0001
71934754|NCT04229303|143391004|OTHER||Slope|2.02|||<|0.0001|TWO_SIDED|90.0|1.688|2.406|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||2.406|1.688|<0.0001
71934755|NCT04229303|143391004|OTHER||Slope|4.73|||<|0.0001|TWO_SIDED|90.0|3.964|5.65|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 1||5.650|3.964|<0.0001
71934756|NCT04229303|143391004|OTHER||Slope|2.12|||<|0.0001|TWO_SIDED|90.0|1.655|2.711|||ANOVA|||Statistics for N-oxide Voriconazole Cmax Day 10||2.711|1.655|<0.0001
71934757|NCT04229303|143391004|OTHER||Slope|4.01|||<|0.0001|TWO_SIDED|90.0|3.135|5.135|||ANOVA|||Statistics for N-oxide Voriconazole Cmax day 10||5.135|3.135|<0.0001
71934758|NCT04229303|143391025|OTHER||Geometric mean ratio|0.13|||||TWO_SIDED|90.0|0.107|0.146||||||Part 3 - ZP-059 20mg: Oral Voriconazole (200mg VFEND)||0.146|0.107|
71934759|NCT04229303|143391025|OTHER||Geometric mean ratio|2.1|||||TWO_SIDED|90.0|1.545|2.853||||||ZP-059 20mg: Part 3 / Part 1||2.853|1.545|
71934760|NCT04229303|143391025|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
71934761|NCT04229303|143391025|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
71934762|NCT04229303|143391026|OTHER||Geometric mean ratio|0.07|||||TWO_SIDED|90.0|0.059|0.075||||||Part 3 ZP-059 20mg: Oral Voriconazole (200mg VFEND®)||0.075|0.059|
71934763|NCT04229303|143391026|OTHER||Geometric mean ratio|1.27|||||TWO_SIDED|90.0|0.85|1.891||||||ZP-059 20mg: Part 3 / Part 1||1.891|0.850|
71934764|NCT04229303|143391026|OTHER||Geometric mean ratio|2.63|||||TWO_SIDED|90.0|1.953|3.544||||||ZP-059 20mg: Part 3 / Part 2 Day 1||3.544|1.953|
71934765|NCT04229303|143391026|OTHER||Geometric mean ratio|1.87|||||TWO_SIDED|90.0|1.386|2.52||||||ZP-059 20mg: Part 3 / Part 2 Day 10||2.520|1.386|
71934766|NCT00606684|143391027|SUPERIORITY_OR_OTHER||Least squares mean difference|0.092|||<|0.001|TWO_SIDED|95.0|0.039|0.144|||ANCOVA|||||0.144|0.039|<0.001
71934767|NCT00606684|143391027|SUPERIORITY_OR_OTHER||Least squares mean difference|0.098|||<|0.001|TWO_SIDED|95.0|0.046|0.15|||ANCOVA|||||0.150|0.046|<0.001
71934768|NCT00606684|143391027|SUPERIORITY_OR_OTHER||Least squares mean difference|0.11|||<|0.001|TWO_SIDED|95.0|0.057|0.162|||ANCOVA|||||0.162|0.057|<0.001
71934769|NCT00606684|143391027|SUPERIORITY_OR_OTHER||Least squares mean difference|0.137|||<|0.001|TWO_SIDED|95.0|0.085|0.19|||ANCOVA|||||0.190|0.085|<0.001
71934770|NCT00606684|143391027|SUPERIORITY_OR_OTHER||Least squares mean difference|0.165|||<|0.001|TWO_SIDED|95.0|0.112|0.217|||ANCOVA|||||0.217|0.112|<0.001
71934771|NCT02763579|143391031|SUPERIORITY||Stratified Hazard Ratio|0.77||||0.017|TWO_SIDED|95.0|0.62|0.96|||Log Rank|||||0.96|0.62|0.0170
71934772|NCT02763579|143391032|SUPERIORITY||Stratified Hazard Ratio|0.7||||0.0069|TWO_SIDED|95.0|0.54|0.91|||Log Rank|||||0.91|0.54|0.0069
71934773|NCT02763579|143391033|SUPERIORITY||Odds Ratio (OR)|0.87|||||TWO_SIDED|95.0|0.55|1.37||||||||1.37|0.55|
71934774|NCT02763579|143391034|SUPERIORITY||Hazard Ratio (HR)|0.715||||0.0063|TWO_SIDED|95.0|0.562|0.911|||Log Rank|||||0.911|0.562|0.0063
71934775|NCT02763579|143391035|SUPERIORITY||Difference in Event Free Rate|8.47||||0.0593|TWO_SIDED|95.0|-0.33|17.27|||Z-test|||PFS Rate at 6 months||17.27|-0.33|0.0593
71934776|NCT02763579|143391035|SUPERIORITY||Difference in Event Free Rate|7.27||||0.0133|TWO_SIDED|95.0|1.52|13.02|||Z-test|||PFS Rate at 1 year||13.02|1.52|0.0133
71934777|NCT02763579|143391036|SUPERIORITY||Difference in Event Free Rate|13.46||||0.0095|TWO_SIDED|95.0|3.29|23.64|||Z-test|||OS Rate at 1 year||23.64|3.29|0.0095
71934778|NCT02763579|143391037|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.221||||0.3604|TWO_SIDED|95.0|0.795|1.874|||Log Rank|||Cough||1.874|0.795|0.3604
71934779|NCT02763579|143391037|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.058||||0.7712|TWO_SIDED|95.0|0.722|1.553|||Log Rank|||Pain in Chest||1.553|0.722|0.7712
71934780|NCT02763579|143391037|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|1.077||||0.6922|TWO_SIDED|95.0|0.747|1.552|||Log Rank|||Pain in Arm or Shoulder||1.552|0.747|0.6922
71934781|NCT02763579|143391037|SUPERIORITY|Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).|Hazard Ratio (HR)|0.748||||0.065|TWO_SIDED|95.0|0.549|1.019|||Log Rank|||Dyspnea||1.019|0.549|0.0650
71934782|NCT02144259|143391044|SUPERIORITY_OR_OTHER||||||<|0.05|||||||GEE|||Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.||||<0.05
71934783|NCT02144259|143391046|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Chi-squared|||||||<0.05
71934784|NCT04169282|143391064|SUPERIORITY|||||||0.108|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.108
71934785|NCT04169282|143391065|SUPERIORITY|||||||0.003|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.003
71691091|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.02||||0.985|TWO_SIDED|90.0|-1.29|1.26|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.26|-1.29|0.985
71934786|NCT04169282|143391066|SUPERIORITY|||||||0.025|||||||t-test, 1 sided|paired t-test for normally distributed and transformed data or Wilcoxon's Signed Rank test for non-parametric paired data||||||0.025
71934787|NCT00621686|143391073|SUPERIORITY_OR_OTHER|||||||0.069|||||||Log Rank|||||||0.069
71934788|NCT01170364|143391088|SUPERIORITY||||||<|0.004|||||||paired sample t-test, two tailed|||||||<0.004
71934789|NCT01381900|143391089|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.644|-0.367|||ANCOVA|||||-0.367|-0.644|<0.001
71934790|NCT01381900|143391089|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.59|STANDARD_ERROR_OF_MEAN|0.071|<|0.001|TWO_SIDED|95.0|-0.731|-0.453|||ANCOVA|||||-0.453|-0.731|<0.001
71934791|NCT01381900|143391090|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.03|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.375|-0.694|||ANCOVA|||||-0.694|-1.375|<0.001
71934792|NCT01381900|143391090|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-1.43|STANDARD_ERROR_OF_MEAN|0.173|<|0.001|TWO_SIDED|95.0|-1.769|-1.089|||ANCOVA|||||-1.089|-1.769|<0.001
71934793|NCT01381900|143391091|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.7|-1.6|||ANCOVA|||||-1.6|-2.7|<0.001
71934794|NCT01381900|143391091|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|-2.9|-1.8|||ANCOVA|||||-1.8|-2.9|<0.001
71934795|NCT01381900|143391092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.26|||||TWO_SIDED|95.0|2.09|5.09|||Regression, Logistic|||||5.09|2.09|
71934796|NCT01381900|143391092|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.99|||||TWO_SIDED|95.0|2.55|6.27|||Regression, Logistic|||||6.27|2.55|
71934797|NCT01381900|143391093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.55|||||TWO_SIDED|95.0|1.45|4.48|||Regression, Logistic|||||4.48|1.45|
71934798|NCT01381900|143391093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.29|||||TWO_SIDED|95.0|1.88|5.75|||Regression, Logistic|||||5.75|1.88|
71934799|NCT02965820|143391113|SUPERIORITY||||||=|0.003|||||||Mixed Models Analysis|||||||=0.0030
71934800|NCT03803085|143391126|SUPERIORITY|||||||0.02|||||||Mixed Models Analysis|||||||0.02
71934801|NCT03803085|143391127|SUPERIORITY|||||||0.03|||||||Mixed Models Analysis|||||||0.03
71934802|NCT03803085|143391128|SUPERIORITY|||||||0.06||||||p\<0.05 was considered significant.|Mixed Models Analysis|||||||0.06
71934803|NCT02345486|143391129|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.001|TWO_SIDED|95.0|0.66|0.74|||Wilcoxon (Mann-Whitney)||"reported mean difference is a difference in proportions."|||0.74|0.66|0.001
71934804|NCT03979677|143391167|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Multiple comparisons were adjusted.|linear mixed-effects models|||||||<.0001
71691092|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.34||||0.665|TWO_SIDED|90.0|-0.95|1.62|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||1.62|-0.95|0.665
71691093|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.86||||0.276|TWO_SIDED|90.0|-0.44|2.15|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.15|-0.44|0.276
71691094|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.34||||0.004|TWO_SIDED|90.0|1.04|3.65|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.65|1.04|0.004
71691095|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.04||||0.011|TWO_SIDED|90.0|0.74|3.35|||ANCOVA|||Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.35|0.74|0.011
71691096|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.78||||0.033|TWO_SIDED|90.0|0.41|3.14|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.14|0.41|0.033
71691097|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.84||||0.302|TWO_SIDED|90.0|-0.5|2.19|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.19|-0.50|0.302
71691098|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.94||||0.255|TWO_SIDED|90.0|-0.42|2.3|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.30|-0.42|0.255
71691099|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.08||||0.198|TWO_SIDED|90.0|-0.3|2.46|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||2.46|-0.30|0.198
71691100|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.68||||0.002|TWO_SIDED|90.0|1.3|4.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||4.06|1.30|0.002
71691101|NCT00572455|142898106|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.68||||0.046|TWO_SIDED|90.0|0.3|3.06|||ANCOVA|||Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.||3.06|0.30|0.046
71691102|NCT04152083|142898122|OTHER||Hazard Ratio (HR)|1.54||||0.0006|TWO_SIDED|95.0|1.2|1.98||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% confidence interval (CI) were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||1.98|1.20|0.0006
71691103|NCT04152083|142898123|OTHER||Hazard Ratio (HR)|1.75|||<|0.0001|TWO_SIDED|95.0|1.41|2.19||Threshold for significance at 0.05 level.|Likelihood ratio test|||The median estimate for each treatment group, hazard ratio, and its 95% CI were based on the stratified Cox model with Efron's method of tie handling. The analysis was censored at the time point of first rescue medication. The stratification factors were concomitant migraine preventive treatment use and region.||2.19|1.41|<0.0001
71691104|NCT04152083|142898124|OTHER||Odds Ratio (OR)|2.27||||0.0009|TWO_SIDED|95.0|1.39|3.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on Cochran-Mantel-Haenszel (CMH) test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.72|1.39|0.0009
71691105|NCT04152083|142898125|OTHER||Odds Ratio (OR)|2.25|||<|0.0001|TWO_SIDED|95.0|1.55|3.25||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Odds ratio and 95% CI were based on CMH test adjusted for the study's stratification factors of concomitant migraine preventive treatment use and region.||3.25|1.55|<0.0001
71691106|NCT00856999|142898129|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<.001
71691107|NCT00856999|142898130|EQUIVALENCE|Non-parametric test equivalent to the dependent t-test|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||||||<.0004
71691108|NCT00656175|142898162|SUPERIORITY_OR_OTHER|||||||0.52||95.0|||||Wilcoxon (Mann-Whitney)|||Wilcoxon sign-rank test used for statistical significance.||||0.52
71691109|NCT03790865|142898163|SUPERIORITY||Mean Difference (Net)|4.0|||<|0.025|TWO_SIDED||||||Mixed Models Analysis|||||||<0.025
71691110|NCT04776928|142898212|SUPERIORITY|||||||0.01|||||||Two-part regression model|||||||0.010
71934805|NCT03979677|143391168|OTHER|HDI and DHI analyzed using linear mixed-effects models with two within-participant factors, Intervention (pre-intervention, post-intervention) and Inventory (DHI, HDI). All models included participant as a random factor. Models constructed using lmer function of the lme package in R and analyzed using anova function in base R. Significant main effects and interactions were evaluated using emmeans . Pairwise comparisons were adjusted to account for false-discovery rates.|||||<|0.0001||||||Point change in DHI was tests.|linear mixed-effects models|||||||<.0001
71934806|NCT00479401|143391193|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority hypothesis comparing pramipexole ER to pramipexole IR was to be tested using a non-inferiority margin of -3 points. The primary efficacy endpoint in UPDRS part II+III was the change from baseline (week 0) to week 33 on the UPDRS Parts II+III score combined. The statistical model was analysis of covariance, controlling for baseline UPDRS Part II+III. Fixed terms in the model were treatment, country, and UPDRS Part II+III score at baseline.|Mean Difference (Final Values)|-0.2|||||TWO_SIDED|95.0|-2.2|1.7|||ANCOVA|Null hypothesis was tested using an analysis of covariance model with α = 0.05 in full analysis set with last observation carried forward.|PPX ER non-inferior to PPX IR, if the lower limit of the confidence interval for the difference is higher than the non-inferiority margin of -3|A non-inferiority hypothesis (H0: μER - μIR \< -3 vs. H1: μER - μIR ≥ -3) comparing pramipexole ER to pramipexole IR was tested using a non-inferiority margin of -3 points.||1.7|-2.2|
71934807|NCT03124381|143391234|NON_INFERIORITY|Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164|||TWO_SIDED|95.0|-7.04|13.42||||||Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.||13.42|-7.04|
71934808|NCT03124381|143391234|SUPERIORITY|Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.|Mean Difference (Net)|3.19|STANDARD_ERROR_OF_MEAN|5.164||0.538|TWO_SIDED|95.0|-7.04|13.42|||ANCOVA|||Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.||13.42|-7.04|0.538
71934809|NCT00947765|143391287|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71934810|NCT00947765|143391288|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71934811|NCT00947765|143391289|SUPERIORITY_OR_OTHER|||||||0.0022||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0022
71934812|NCT00947765|143391290|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.003
71934813|NCT00947765|143391291|SUPERIORITY_OR_OTHER|||||||0.0127||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0127
71934814|NCT00947765|143391292|SUPERIORITY_OR_OTHER|||||||0.0184||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0184
71934815|NCT00947765|143391293|SUPERIORITY_OR_OTHER|||||||0.0058||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0058
71934816|NCT00947765|143391294|SUPERIORITY_OR_OTHER|||||||0.0064||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0064
71934817|NCT02462382|143391350|EQUIVALENCE|The univariate analyses were conducted using Independent t-Tests for continuous variables and Fisher Exact Tests or Chi-Square Tests of Independence for categorical comparisons.|Fisher Exact Tests|0.041||||0.006|TWO_SIDED|||||POD 1 1cm incision.|Chi-squared|||Comparisons of pain scores using a Visual Analog Scale (VAS) based on Post-Operative Day (POD).||||.006
71934818|NCT01084005|143391376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.64|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.81|-0.48|||ANCOVA|||||-0.48|-0.81|<0.0001
71934819|NCT01084005|143391377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.45|-0.24|||ANCOVA|||||-0.24|-0.45|<0.0001
71934820|NCT01084005|143391378|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|-0.71|-0.43|||ANCOVA|||||-0.43|-0.71|<0.0001
71934821|NCT01084005|143391379|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001||95.0|-0.77|-0.47|||ANCOVA|||||-0.47|-0.77|<0.0001
71934822|NCT01084005|143391380|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.7|STANDARD_ERROR_OF_MEAN|4.8|<|0.0001||95.0|-30.2|-11.2|||ANCOVA|||||-11.2|-30.2|<0.0001
71934823|NCT01084005|143391381|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001||95.0|-24.7|-12.6|||Mixed Models Analysis|||||-12.6|-24.7|<0.0001
71934824|NCT01084005|143391382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.5|STANDARD_ERROR_OF_MEAN|3.4|<|0.0001||95.0|-28.1|-14.8|||Mixed Models Analysis|||||-14.8|-28.1|<0.0001
71934825|NCT01084005|143391383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.6|STANDARD_ERROR_OF_MEAN|4.2|<|0.0001||95.0|-29.8|-13.4|||Mixed Models Analysis|||||-13.4|-29.8|<0.0001
71934826|NCT01084005|143391384|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|8.319|||<|0.0001||95.0|3.321|20.837|||Regression, Logistic|||||20.837|3.321|<0.0001
71934827|NCT01084005|143391387|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.214||||0.0048|TWO_SIDED|95.0|0.073|0.625|||Regression, Logistic|||Lina 5 mg qd vs Placebo||0.625|0.073|0.0048
71934828|NCT02967133|143391418|SUPERIORITY|||||||0.5186|||||||Log Rank|||||||0.5186
71934829|NCT01034137|143391419|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.996|||<|0.001|TWO_SIDED|95.0|1.589|2.506|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the Cochran-Mantel-Haenszel (CMH) test taking into account the stratification factors used for randomization.||2.506|1.589|< 0.001
71934830|NCT01034137|143391419|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.855|||<|0.001|TWO_SIDED|95.0|1.481|2.323|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||2.323|1.481|< 0.001
71934831|NCT01034137|143391419|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.616|TWO_SIDED|95.0|0.915|1.16|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.||1.160|0.915|0.616
71934832|NCT00936377|143391461|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71934833|NCT00936377|143391461|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71934834|NCT00936377|143391462|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71934835|NCT00936377|143391462|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||||||0.05
71934836|NCT00936377|143391463|SUPERIORITY_OR_OTHER|||||||0.066|||||||Wilcoxon (Mann-Whitney)|||||||0.066
71934837|NCT00936377|143391463|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71934838|NCT00936377|143391464|SUPERIORITY_OR_OTHER|||||||0.18||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||Percentage of CIWA scores rates as severe||||0.18
71934839|NCT00936377|143391464|SUPERIORITY_OR_OTHER|||||||0.35||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||||||0.35
71934840|NCT00936377|143391465|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For hypotension||||1
71934841|NCT00936377|143391465|SUPERIORITY_OR_OTHER|||||||0.47|||||||Fisher Exact|||For hypotension||||0.47
71934842|NCT00936377|143391465|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||For bradycardia||||1
71934843|NCT00936377|143391465|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||For bradycardia||||0.2
71934844|NCT00936377|143391466|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Repeated measures ANOVA|||||||<0.05
71934845|NCT00936377|143391467|SUPERIORITY_OR_OTHER|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71934846|NCT00936377|143391467|SUPERIORITY_OR_OTHER|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||0.95
71934847|NCT00936377|143391468|SUPERIORITY_OR_OTHER|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||||||0.43
71934848|NCT00936377|143391468|SUPERIORITY_OR_OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71934849|NCT01764854|143391469|SUPERIORITY|||||||0.46|||||||ANCOVA|||AZD1722 in-patient and Placebo in-patient are not included in this analysis since it was only a one week evaluation period and an effect was not expected. Also the size (n=8) of the group was too small to .perform this analysis.||||0.46
71934850|NCT01764854|143391470|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||AZD1722 out-patient and Placebo out-patient were not included in this analysis since stool was only collected in the clinical pharmacology unit of the in-patient groups.||||<0.0001
71934851|NCT01275313|143391494|EQUIVALENCE|Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.||||||0.77|||||||Chi-squared, Corrected|||Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.||||0.77
71934852|NCT01967888|143391504|SUPERIORITY||t-test|-1.2||||0.542|TWO_SIDED|95.0|-14.3|0.0|||Cochran-Mantel-Haenszel|||||000|-14.3|0.542
71934853|NCT01967888|143391505|SUPERIORITY||least square mean difference|-0.1601778||||0.092|TWO_SIDED|95.0|-0.317803|-0.0025525|||t-test, 2 sided|||||-0.0025525|-0.3178030|0.092
71934854|NCT01967888|143391506|SUPERIORITY||least square mean difference|-0.1178242||||0.161|TWO_SIDED|95.0|-0.287431|0.0517825|||t-test, 2 sided|||||0.0517825|-0.2874310|0.161
71934855|NCT01967888|143391507|SUPERIORITY||least square mean difference|0.0136||||0.846|TWO_SIDED|95.0|-0.0508|0.0781|||t-test, 2 sided|||||0.0781|-0.0508|0.846
71934856|NCT01967888|143391508|SUPERIORITY||least square mean difference|-0.025||||0.817|TWO_SIDED|95.0|-0.0939|0.0689|||t-test, 2 sided|||||0.0689|-0.0939|0.817
71934857|NCT01967888|143391509|SUPERIORITY||least square mean difference|-9.4641||||0.57|TWO_SIDED|95.0|-42.49|23.5618|||Mixed Models Analysis|||||23.5618|-42.4900|0.570
71934858|NCT01967888|143391510|SUPERIORITY||least square mean difference|-22.9454|||=|0.074|TWO_SIDED|95.0|-48.1826|2.2918|||Mixed Models Analysis|||||2.2918|-48.1826|=0.074
71934859|NCT01967888|143391511|SUPERIORITY||least square mean difference|-0.2074|||=|0.358|TWO_SIDED|95.0|-0.6538|0.2389|||Mixed Models Analysis|||||0.2389|-0.6538|=0.358
71934860|NCT01967888|143391512|SUPERIORITY||least square mean difference|-0.277|||=|0.288|TWO_SIDED|95.0|-0.7936|0.2396|||Mixed Models Analysis|||||0.2396|-0.7936|=0.288
71934861|NCT01967888|143391513|SUPERIORITY||least square mean difference|0.09716|||=|0.98|TWO_SIDED|95.0|-7.41834|7.61266|||Mixed Models Analysis|||||7.61266|-7.41834|=0.980
71934862|NCT01967888|143391514|SUPERIORITY||least square mean difference|1.07617|||=|0.785|TWO_SIDED|95.0|-6.76562|8.91796|||Mixed Models Analysis|||||8.91796|-6.76562|=0.785
71934863|NCT01967888|143391515|SUPERIORITY|||||||0.176|||||||Wilcoxon (Mann-Whitney)|||||||0.176
71934864|NCT01967888|143391516|SUPERIORITY|||||||0.403|||||||Wilcoxon (Mann-Whitney)|||||||0.403
71934865|NCT01967888|143391517|SUPERIORITY||Treatment effect|2.1||||0.842|TWO_SIDED|95.0|-18.2|22.33|||Chi-squared|||||22.33|-18.20|0.842
71934866|NCT01967888|143391518|SUPERIORITY||Hazard Ratio (HR)|3.21||||0.339|TWO_SIDED|95.0|0.29|34.97|||Anderson-Gill model|||||34.97|0.29|0.339
71934867|NCT01967888|143391519|SUPERIORITY||Treatment effect|5.0||||0.64|TWO_SIDED|95.0|-15.91|25.93|||Chi-squared|||||25.93|-15.91|0.640
71934868|NCT01967888|143391525|SUPERIORITY|||||||0.448|||||||Wilcoxon rank-sum test|||||||0.448
71934869|NCT01967888|143391526|SUPERIORITY|||||||0.91|||||||Wilcoxon rank-sum test|||||||0.910
71934870|NCT01967888|143391527|SUPERIORITY|||||||1|||||||Wilcoxon rank-sum test|||||||1.000
71934871|NCT01967888|143391532|SUPERIORITY||least square mean difference|31.3491|||=|0.5018|TWO_SIDED|95.0|-60.998|123.7|||Mixed Models Analysis|||||123.70|-60.9980|=0.5018
71934872|NCT01967888|143391533|SUPERIORITY||Least square mean difference|23.5454|||=|0.4537|TWO_SIDED|95.0|-38.6619|85.7528|||Mixed Models Analysis|||||85.7528|-38.6619|=0.4537
71934873|NCT01859325|143391578|SUPERIORITY||Median Difference (Final Values)|-0.36||||0.406|TWO_SIDED|95.0|-1.41|0.67|||Wilcoxon (Mann-Whitney)|||Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.||0.67|-1.41|0.406
71934874|NCT03840135|143391589|SUPERIORITY||Mean Difference (Final Values)|-0.22|||<|0.05|TWO_SIDED|95.0|-0.6|0.16|||t-test, 2 sided|||The value of δ = -0.52 days was considered as the boundary of superiority. The end of the fever period is considered to have an axillary body temperature of ≤36.9 ° C in two consecutive measurements (morning-evening / evening-morning).||0.16|-0.6|<0.05
71934875|NCT03840135|143391590|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71934876|NCT03840135|143391591|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71934877|NCT03840135|143391592|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71934878|NCT03840135|143391593|SUPERIORITY||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71934879|NCT03840135|143391594|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71934880|NCT03840135|143391595|SUPERIORITY||||||<|0.05|||||||χ2 Pearson criterion|||||||<0.05
71934881|NCT03840135|143391598|SUPERIORITY||||||<|0.05|||||||Fisher Exact|||||||<0.05
71934882|NCT03840135|143391599|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71934883|NCT01827371|143391600|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|1.32|||||TWO_SIDED|98.33|0.72|1.93||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.93|0.72|
71934884|NCT01827371|143391600|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.86|||||TWO_SIDED|98.33|0.26|1.47||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.47|0.26|
71934885|NCT01827371|143391600|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.41|||||TWO_SIDED|98.33|-0.17|1.0007||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~Sample Size: The SD for log2 PRNT based on a prior study was\~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"||1.0007|-0.17|
71934886|NCT01827371|143391601|SUPERIORITY_OR_OTHER|||||||0.4782|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Pain at Injection Site ' Arm A) = Pr('Pain at Injection Site ' Arm D) H1: Pr('Pain at Injection Site ' Arm A) not = Pr('Pain at Injection Site ' Arm D)"||||0.4782
71934887|NCT01827371|143391601|SUPERIORITY_OR_OTHER|||||||0.1704|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Itchiness at Injection Site' Arm A) = Pr('Itchiness at Injection Site' Arm D) H1: Pr('Itchiness at Injection Site' Arm A) not = Pr('Itchiness at Injection Site' Arm D)"||||0.1704
71934888|NCT01827371|143391601|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm pain' Arm A) = Pr('Underarm pain' Arm D) H1: Pr('Underarm pain' Arm A) not = Pr('Underarm pain' Arm D)"||||1.000
71934889|NCT01827371|143391601|SUPERIORITY_OR_OTHER|||||||0.6171|TWO_SIDED|||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm swelling' Arm A) = Pr('Underarm swelling' Arm D) H1: Pr('Underarm swelling' Arm A) not = Pr('Underarm swelling' Arm D)"||||0.6171
71934890|NCT01827371|143391601|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Redness at Injection Site' Arm A) = Pr('Redness at Injection Site' Arm D) H1: Pr('Redness at Injection Site' Arm A) not = Pr('Redness at Injection Site' Arm D)"||||<0.0001
71934891|NCT01827371|143391601|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Swelling at Injection Site' Arm A) = Pr('Swelling at Injection Site' Arm D) H1: Pr('Swelling at Injection Site' Arm A) not = Pr('Swelling at Injection Site' Arm D)"||||0.0050
71934892|NCT01827371|143391601|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr('Any Solicited Local Reaction' Arm A) = Pr('Any Solicited Local Reaction' Arm D) H1: Pr('Any Solicited Local Reaction' Arm A) not = Pr('Any Solicited Local Reaction' Arm D)"||||0.0012
71934893|NCT01827371|143391602|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.76|||||TWO_SIDED|98.33|0.37|1.15||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) \< 1 or GMT(Arm A)/GMT(Arm B) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||1.15|0.37|
71934894|NCT01827371|143391602|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.3|||||TWO_SIDED|98.33|-0.06|0.67||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) \< 1 or GMT(Arm A)/GMT(Arm C) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.67|-0.06|
71934895|NCT01827371|143391602|NON_INFERIORITY_OR_EQUIVALENCE|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|-0.1|||||TWO_SIDED|98.33|-0.5|0.3||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) \< 1 or GMT(Arm A)/GMT(Arm D) \< 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."||0.30|-0.50|
71934896|NCT01361607|143391606|SUPERIORITY||Median Difference (Final Values)|-1.84||||0.2735|TWO_SIDED|95.0|-6.19|1.5|||Wilcoxon (Mann-Whitney)|||||1.50|-6.19|0.2735
71934897|NCT01809314|143391617|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.||||<0.0001
71934898|NCT01809314|143391618|SUPERIORITY_OR_OTHER|||||||0.001|||||||Wilcoxon signed-rank test|||Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.||||0.001
71934899|NCT00219557|143391625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.758||||0.1026|TWO_SIDED|95.0|0.49|1.17||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.170|0.490|0.1026
71934900|NCT00219557|143391636|SUPERIORITY_OR_OTHER||Difference in response rate|4.3||||0.661|TWO_SIDED|95.0|-4.0|12.7|||Fisher Exact|||Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).||12.7|-4.0|0.661
71934901|NCT00219557|143391638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9648||||0.4466|TWO_SIDED|95.0|0.54|1.73||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).||1.7300|0.5400|0.4466
71934902|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.44|||||TWO_SIDED|95.0|-19.06|2.19||||||For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||2.19|-19.06|
71934903|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.02|||||TWO_SIDED|95.0|-15.4|3.36||||||For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||3.36|-15.4|
71934904|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.32|||||TWO_SIDED|95.0|-23.77|5.12||||||For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.12|-23.77|
71934905|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.73|||||TWO_SIDED|95.0|-15.25|5.79||||||For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.79|-15.25|
71934906|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.11|||||TWO_SIDED|95.0|-15.83|5.61||||||For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||5.61|-15.83|
71934907|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-18.72|12.06||||||For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.06|-18.72|
71934908|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.41|||||TWO_SIDED|95.0|-1.62|22.44||||||For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.44|-1.62|
71934909|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||||TWO_SIDED|95.0|-16.55|7.96||||||For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||7.96|-16.55|
71934910|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.37|||||TWO_SIDED|95.0|-7.57|22.32||||||For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.32|-7.57|
71934911|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.51|||||TWO_SIDED|95.0|-1.28|26.3||||||For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||26.30|-1.28|
71934912|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||||TWO_SIDED|95.0|-5.7|25.49||||||For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||25.49|-5.70|
71934913|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|||||TWO_SIDED|95.0|-4.81|32.07||||||For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||32.07|-4.81|
71934914|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.67|||||TWO_SIDED|95.0|-11.62|20.96||||||For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-11.62|
71934915|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28|||||TWO_SIDED|95.0|-15.1|12.54||||||For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||12.54|-15.1|
71934916|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.43|||||TWO_SIDED|95.0|-4.67|15.53||||||For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.53|-4.67|
71934917|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.83|||||TWO_SIDED|95.0|-32.34|0.67||||||For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.67|-32.34|
71934918|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.58|||||TWO_SIDED|95.0|-24.12|0.96||||||For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||0.96|-24.12|
71934919|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.65|||||TWO_SIDED|95.0|-35.47|-1.83||||||For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||-1.83|-35.47|
71934920|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.92|||||TWO_SIDED|95.0|-29.16|1.32||||||For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||1.32|-29.16|
71934921|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.1|||||TWO_SIDED|95.0|-20.97|6.77||||||For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||6.77|-20.97|
71691111|NCT00103285|142898215|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.17|||||TWO_SIDED|95.0|1.61|16.63|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points.|Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||16.63|1.61|
71934922|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.62|||||TWO_SIDED|95.0|-28.28|9.04||||||For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||9.04|-28.28|
71934923|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.14|||||TWO_SIDED|95.0|-1.27|33.54||||||For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||33.54|-1.27|
71934924|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.8|||||TWO_SIDED|95.0|-18.78|15.18||||||For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||15.18|-18.78|
71934925|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.59|||||TWO_SIDED|95.0|-3.22|36.39||||||For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.39|-3.22|
71934926|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|||||TWO_SIDED|95.0|-5.68|26.47||||||For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||26.47|-5.68|
71934927|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59|||||TWO_SIDED|95.0|-20.19|23.36||||||For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.36|-20.19|
71934928|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.24|||||TWO_SIDED|95.0|-7.62|40.1||||||For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||40.1|-7.62|
71934929|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.76|||||TWO_SIDED|95.0|-17.49|23.02||||||For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||23.02|-17.49|
71934930|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.87|||||TWO_SIDED|95.0|-16.29|22.03||||||For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.03|-16.29|
71934931|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-9.81|20.92||||||For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||20.92|-9.81|
71934932|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.97|||||TWO_SIDED|95.0|-19.52|7.57||||||For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.57|-19.52|
71934933|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.64|||||TWO_SIDED|95.0|-19.75|8.46||||||For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.46|-19.75|
71934934|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.53|||||TWO_SIDED|95.0|-39.11|4.05||||||For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||4.05|-39.11|
71934935|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.25|||||TWO_SIDED|95.0|-26.5|2.0||||||For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||2.00|-26.5|
71934936|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.99|||||TWO_SIDED|95.0|-23.13|9.15||||||For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||9.15|-23.13|
71934937|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|||||TWO_SIDED|95.0|-30.48|16.31||||||For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.31|-30.48|
71934938|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|-5.86|27.63||||||For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.63|-5.86|
71934939|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.1|||||TWO_SIDED|95.0|-24.11|1.91||||||For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||1.91|-24.11|
71934940|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.13|||||TWO_SIDED|95.0|-24.26|14.0||||||For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||14.00|-24.26|
71691112|NCT00103285|142898215|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|1.21|3.27|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.27|1.21|
71934941|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.13|||||TWO_SIDED|95.0|-14.18|24.44||||||For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.44|-14.18|
71934942|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.33|||||TWO_SIDED|95.0|-26.25|13.59||||||For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.59|-26.25|
71934943|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.03|||||TWO_SIDED|95.0|-15.26|33.32||||||For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.32|-15.26|
71934944|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|||||TWO_SIDED|95.0|-25.71|26.82||||||For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||26.82|-25.71|
71934945|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.97|||||TWO_SIDED|95.0|-24.07|28.01||||||For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||28.01|-24.07|
71934946|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.48|||||TWO_SIDED|95.0|-5.89|24.86||||||For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.86|-5.89|
71934947|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.01|||||TWO_SIDED|95.0|-43.19|3.17||||||For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||3.17|-43.19|
71934948|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.57|||||TWO_SIDED|95.0|-27.24|10.1||||||For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.10|-27.24|
71934949|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.07|||||TWO_SIDED|95.0|-41.1|8.96||||||For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||8.96|-41.10|
71934950|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-24.11|||||TWO_SIDED|95.0|-42.72|-5.5||||||For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||-5.50|-42.72|
71934951|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-29.66|10.61||||||For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||10.61|-29.66|
71934952|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.24|||||TWO_SIDED|95.0|-47.93|7.46||||||For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||7.46|-47.93|
71934953|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|3.23|46.77||||||For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.77|3.23|
71934954|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.25|||||TWO_SIDED|95.0|-13.49|25.99||||||For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||25.99|-13.49|
71934955|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.64|||||TWO_SIDED|95.0|-7.12|46.41||||||For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||46.41|-7.12|
71934956|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.02|||||TWO_SIDED|95.0|0.38|43.66||||||For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.66|0.38|
71934957|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.12|||||TWO_SIDED|95.0|-18.49|38.73||||||For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-18.49|
71934958|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-13.98|55.65||||||For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||55.65|-13.98|
71934959|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-19.02|42.83||||||For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.83|-19.02|
71934960|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.9|||||TWO_SIDED|95.0|-16.13|39.94||||||For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||39.94|-16.13|
71934961|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-23.38|23.38||||||For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||23.38|-23.38|
71934962|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.66|||||TWO_SIDED|95.0|-34.53|17.21||||||For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups||17.21|-34.53|
71934963|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.98|||||TWO_SIDED|95.0|-52.01|26.04||||||For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||26.04|-52.01|
71934964|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.32|||||TWO_SIDED|95.0|-71.87|19.24||||||For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||19.24|-71.87|
71934965|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|||||TWO_SIDED|95.0|-26.59|14.31||||||For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||14.31|-26.59|
71934966|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.99|||||TWO_SIDED|95.0|-35.46|11.48||||||For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||11.48|-35.46|
71934967|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|||||TWO_SIDED|95.0|-20.97|49.04||||||For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||49.04|-20.97|
71934968|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.39|||||TWO_SIDED|95.0|-15.83|62.61||||||For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.61|-15.83|
71934969|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.95|||||TWO_SIDED|95.0|-30.84|38.73||||||For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.73|-30.84|
71934970|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.56|||||TWO_SIDED|95.0|-13.08|62.2||||||For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||62.20|-13.08|
71934971|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|||||TWO_SIDED|95.0|-38.65|34.94||||||For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||34.94|-38.65|
71934972|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.65|||||TWO_SIDED|95.0|-37.43|56.73||||||For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||56.73|-37.43|
71934973|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.16|||||TWO_SIDED|95.0|-71.22|97.54||||||For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||97.54|-71.22|
71934974|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.81|||||TWO_SIDED|95.0|-22.61|68.22||||||For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||68.22|-22.61|
71934975|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75|||||TWO_SIDED|95.0|-39.1|35.59||||||For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||35.59|-39.10|
71934976|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.98|||||TWO_SIDED|95.0|1.09|46.86||||||For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||46.86|1.09|
71934977|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.04|||||TWO_SIDED|95.0|-39.03|63.11||||||For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||63.11|-39.03|
71934978|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.89|||||TWO_SIDED|95.0|-20.74|58.52||||||For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||58.52|-20.74|
71934979|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-48.33|||||TWO_SIDED|95.0|-111.94|15.28||||||For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||15.28|-111.94|
71934980|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.93|||||TWO_SIDED|95.0|-22.59|20.74||||||For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.74|-22.59|
71934981|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.22|||||TWO_SIDED|95.0|-24.98|39.43||||||For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||39.43|-24.98|
71934982|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||||TWO_SIDED|95.0|-57.71|77.71||||||For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.71|-57.71|
71934983|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.04|||||TWO_SIDED|95.0|-58.87|24.79||||||For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||24.79|-58.87|
71934984|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|||||TWO_SIDED|95.0|-43.1|13.1||||||For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||13.10|-43.10|
71934985|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.78|||||TWO_SIDED|95.0|-41.75|57.3||||||For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||57.30|-41.75|
71934986|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-53.79|20.46||||||For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.46|-53.79|
71934987|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.11|||||TWO_SIDED|95.0|-73.14|30.92||||||For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.92|-73.14|
71934988|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-32.22|||||TWO_SIDED|95.0|-115.58|51.13||||||For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||51.13|-115.58|
71934989|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.33|||||TWO_SIDED|95.0|-18.6|125.26||||||For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||125.26|-18.60|
71691113|NCT00103285|142898215|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|1.03|3.34|||Mixed Models Analysis||Odds Ratios in this Statistical Analysis corresponds to all four time points|Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.||3.34|1.03|
71934990|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.33|||||TWO_SIDED|95.0|-34.92|41.58||||||For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||41.58|-34.92|
71934991|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.67|||||TWO_SIDED|95.0|-34.3|20.96||||||For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||20.96|-34.3|
71934992|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-58.94|100.6||||||For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||100.60|-58.94|
71934993|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.33|||||TWO_SIDED|95.0|-44.54|63.2||||||For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||63.20|-44.54|
71934994|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-35.3|75.3||||||For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||75.30|-35.30|
71934995|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.5|||||TWO_SIDED|95.0|-51.66|36.66||||||For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||36.66|-51.66|
71934996|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-36.06|69.39||||||For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||69.39|-36.06|
71934997|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|||||TWO_SIDED|95.0|-76.36|86.36||||||For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.36|-76.36|
71934998|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.78|||||TWO_SIDED|95.0|-77.63|42.08||||||For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||42.08|-77.63|
71934999|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-62.33|28.99||||||For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-62.33|
71935000|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-79.59|96.26||||||For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-79.59|
71935001|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-89.98|52.94||||||For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||52.94|-89.98|
71935002|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.0|||||TWO_SIDED|95.0|-133.08|93.08||||||For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||93.08|-133.08|
71935003|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.67|||||TWO_SIDED|95.0|-151.27|77.94||||||For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||77.94|-151.27|
71691114|NCT00103285|142898216|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.542|||||TWO_SIDED|95.0|1.974|3.273|||Regression, Cox|||4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (\<0.1%) or positive (\>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.||3.273|1.974|
71691115|NCT00103285|142898218|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.131|||||TWO_SIDED|95.0|0.101|0.17|||Chi-squared|||MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.||0.17|0.101|
71935004|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-72.58|65.91||||||For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||65.91|-72.58|
71935005|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.33|||||TWO_SIDED|95.0|-16.45|163.12||||||For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||163.12|-16.45|
71935006|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|||||TWO_SIDED|95.0|-48.23|41.56||||||For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||41.56|-48.23|
71935007|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.62|||||TWO_SIDED|95.0|-74.75|106.0||||||For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||106.00|-74.75|
71935008|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-17.22|83.89||||||For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||83.89|-17.22|
71935009|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.17|||||TWO_SIDED|95.0|-58.04|66.37||||||For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-58.04|
71935010|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.21|||||TWO_SIDED|95.0|-28.19|38.61||||||For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||38.61|-28.19|
71935011|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.25|||||TWO_SIDED|95.0|-40.94|103.44||||||For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||103.44|-40.94|
71935012|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.08|||||TWO_SIDED|95.0|-91.02|145.18||||||For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||145.18|-91.02|
71935013|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.28|||||TWO_SIDED|95.0|-99.46|68.9||||||For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||68.90|-99.46|
71935014|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-69.69|19.69||||||For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||19.69|-69.69|
71691116|NCT00103285|142898219|OTHER||Odds Ratio (OR)|4.1|||||TWO_SIDED|95.0|1.31|12.73|||Regression, Logistic|||Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.||12.73|1.31|
71935015|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-77.4|77.4||||||For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.40|-77.40|
71935016|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-82.89|54.32||||||For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||54.32|-82.89|
71935017|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-87.02|78.69||||||For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||78.69|-87.02|
71935018|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-25.0|||||TWO_SIDED|95.0|-184.57|134.57||||||For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||134.57|-184.57|
71935019|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33|||||TWO_SIDED|95.0|-105.73|89.06||||||For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||89.06|-105.73|
71935020|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|79.17|||||TWO_SIDED|95.0|-29.72|188.06||||||For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||188.06|-29.72|
71935021|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-57.74|49.41||||||For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||49.41|-57.74|
71935022|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-39.62|72.95||||||For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||72.95|-39.62|
71935023|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.62|||||TWO_SIDED|95.0|-6.42|61.66||||||For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||61.66|-6.42|
71935024|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.19|||||TWO_SIDED|95.0|-29.28|81.66||||||For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||81.66|-29.28|
71935025|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|||||TWO_SIDED|95.0|-63.74|56.6||||||For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||56.6|-63.74|
71935026|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-31.66|79.28||||||For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.28|-31.66|
71935027|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-53.82|110.96||||||For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.96|-53.82|
71935028|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.16|||||TWO_SIDED|95.0|-94.53|34.21||||||For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||34.21|-94.53|
71691117|NCT00913081|142898222|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow. Because quercetin has not been used to inhibit flushing from niacin in humans, sample size could not be determined statistically. A sample size of 8 men and 8 women was expected to allow separate estimates of effect size, variability, and shape of distribution for men and women.||||0.5
71691118|NCT00913081|142898222|SUPERIORITY_OR_OTHER|||||||0.8|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.8
71691119|NCT00913081|142898222|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.||||0.5
71691120|NCT00511173|142898297|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_DEVIATION|4.5|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in \> 100 patients enrolled into each group.||||< 0.05
71691121|NCT03569098|142898301|SUPERIORITY||Difference in LS mean|0.32|STANDARD_ERROR_OF_MEAN|0.441||0.7669|TWO_SIDED|95.0|-0.55|1.19||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|Mixed Model for Repeated Measures (MMRM)|||Dysport 300 U versus Placebo.||1.19|-0.55|0.7669
71691122|NCT03569098|142898301|SUPERIORITY||Difference in LS mean|-0.36|STANDARD_ERROR_OF_MEAN|0.444||0.2085|TWO_SIDED|95.0|-1.24|0.51||One-sided P-value. The model includes the fixed categorical effects of treatment group, visit, treatment group-by-visit interaction, and the stratification factor as fixed categorical covariates and the Baseline value as a fixed continuous covariate.|MMRM|||Dysport 500 U versus Placebo.||0.51|-1.24|0.2085
71691123|NCT00758498|142898315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.9|||<|0.0001|TWO_SIDED|95.0|2.07|3.71|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||3.71|2.07|<0.0001
71691124|NCT00758498|142898315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.9|||<|0.0001|TWO_SIDED|95.0|6.06|7.69|||ANCOVA|Treatment was a factor and baseline value was a co-variate||||7.69|6.06|<0.0001
71691125|NCT00758498|142898316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.8341|TWO_SIDED|95.0|-0.2|0.25|||ANOVA|||||0.25|-0.20|0.8341
71691126|NCT00758498|142898316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0441|TWO_SIDED|95.0|-0.5|-0.05|||ANCOVA|||||-0.05|-0.50|0.0441
71691127|NCT00758498|142898317|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71691128|NCT00758498|142898317|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71691129|NCT00758498|142898318|SUPERIORITY_OR_OTHER|||||||0.0012|||||||ANCOVA|Treatment comparisons made use of an analysis of covariance (ANCOVA) analysis with treatment as a factor and baseline value as a covariate||||||0.0012
71691130|NCT00758498|142898318|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis by ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
71691131|NCT00758498|142898319|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Analysis of treatment comparisons is based on an analysis of variance (ANCOVA) with treatment as a factor and the baseline value as covariate|ANCOVA|||||||<0.0001
71691132|NCT00758498|142898319|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on an ANCOVA with treatment as a factor and baseline value as a covariate||||||<0.0001
71691133|NCT00758498|142898320|SUPERIORITY_OR_OTHER|||||||0.0022|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||0.0022
71691134|NCT00758498|142898320|SUPERIORITY_OR_OTHER|||||||0.0033|||||||ANCOVA|Analysis of treatment comparisons was based on ANCOVA with treatment as a factor and the baseline as a covariate||||||0.0033
71691135|NCT00758498|142898326|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as factor and baseline value as a covariate.||||||<0.0001
71691136|NCT00758498|142898326|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as factor and baseline value as a covariate||||||<0.0001
71691137|NCT00758498|142898327|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate||||||<0.0001
71691138|NCT00758498|142898327|SUPERIORITY_OR_OTHER||Least square mean||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
71691139|NCT00758498|142898328|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.||||||<0.0001
71691140|NCT00758498|142898328|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is from an ANCOVA with treatment as a factor and the baseline value as a covariate||||||<0.0001
71691141|NCT00758498|142898330|SUPERIORITY_OR_OTHER|||||||0.8262|||||||ANOVA|||||||0.8262
71691142|NCT00758498|142898330|SUPERIORITY_OR_OTHER|||||||0.004|||||||ANOVA|||||||0.0040
71691143|NCT00758498|142898331|SUPERIORITY_OR_OTHER|||||||0.9595|||||||ANOVA|||||||0.9595
71691144|NCT00758498|142898331|SUPERIORITY_OR_OTHER||Least square mean|||||0.3539|||||||ANOVA|||||||0.3539
71691145|NCT00758498|142898332|SUPERIORITY_OR_OTHER|||||||0.1038|||||||ANOVA|||||||0.1038
71691146|NCT00758498|142898332|SUPERIORITY_OR_OTHER|||||||0.8112|||||||ANOVA|||||||0.8112
71691147|NCT03782987|142898353|OTHER||Geometric mean (gMean) ratio (%) (T/ R)|649.48|STANDARD_ERROR_OF_MEAN|27.7|||TWO_SIDED|90.0|541.29|779.29|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||779.29|541.29|
71691148|NCT03782987|142898354|OTHER||gMean ratio (%) (T/ R)|166.88|STANDARD_ERROR_OF_MEAN|17.7|||TWO_SIDED|90.0|148.42|187.64|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||187.64|148.42|
71935029|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-83.26|49.93||||||For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||49.93|-83.26|
71935030|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-97.98|88.45||||||For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||88.45|-97.98|
71935031|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-86.68|64.46||||||For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.46|-86.68|
71935032|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-55.41|64.93||||||For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||64.93|-55.41|
71691149|NCT03782987|142898355|OTHER||gMean ratio (%) (T/ R)|931.41|STANDARD_ERROR_OF_MEAN|25.9|||TWO_SIDED|90.0|785.19|1104.85|||||Confidence intervals were calculated based on the residual error from the ANOVA. Standard error of the mean is actually intra-individual geometric coefficient of variance (gCV).|Statistical model was an analysis of variance (ANOVA) on the logarithmic scale including 'subjects' as random effect and 'treatment' as fixed effect.||1104.85|785.19|
71691150|NCT01516736|142898359|EQUIVALENCE|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
71691151|NCT01516736|142898359|NON_INFERIORITY|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|TWO_SIDED|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~1. that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~2. that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."||0.08|-0.40|0.05
71691152|NCT01781208|142898395|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.68, unadjusted for age, gender, and histologic inflammation.|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
71691153|NCT01781208|142898395|SUPERIORITY_OR_OTHER||||||<|0.0001||||||r=0.73, unadjusted for age, gender, and histologic inflammation score|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.||||<0.0001
71691154|NCT03365934|142898396|SUPERIORITY|||||||0.071225|||||||t-test, 2 sided|||||||0.071225
71691155|NCT03365934|142898396|SUPERIORITY|||||||0.092027|||||||t-test, 2 sided|||||||0.092027
71691156|NCT03365934|142898396|SUPERIORITY|||||||0.601716|||||||t-test, 2 sided|||||||0.601716
71691157|NCT03365934|142898396|SUPERIORITY|||||||0.639911|||||||t-test, 2 sided|||||||0.639911
71691158|NCT03365934|142898396|SUPERIORITY|||||||0.842476|||||||t-test, 2 sided|||||||0.842476
71691159|NCT03365934|142898396|SUPERIORITY|||||||0.999941|||||||t-test, 2 sided|||||||0.999941
71691160|NCT03365934|142898396|SUPERIORITY|||||||0.883479|||||||t-test, 2 sided|||||||0.883479
71691161|NCT03365934|142898396|SUPERIORITY|||||||0.782208|||||||t-test, 2 sided|||||||0.782208
71691162|NCT03365934|142898396|SUPERIORITY|||||||0.607134|||||||t-test, 2 sided|||||||0.607134
71691163|NCT03365934|142898396|SUPERIORITY|||||||0.939549|||||||t-test, 2 sided|||||||0.939549
71691164|NCT03365934|142898396|SUPERIORITY|||||||0.86475|||||||t-test, 2 sided|||||||0.86475
71691165|NCT03365934|142898396|SUPERIORITY|||||||0.704759|||||||t-test, 2 sided|||||||0.704759
71691166|NCT03365934|142898396|SUPERIORITY|||||||0.999989|||||||t-test, 2 sided|||||||0.999989
71691167|NCT03365934|142898396|SUPERIORITY|||||||0.997568|||||||t-test, 2 sided|||||||0.997568
71691168|NCT03365934|142898396|SUPERIORITY|||||||0.999518|||||||t-test, 2 sided|||||||0.999518
71691169|NCT03365934|142898397|SUPERIORITY|||||||0.985332|||||||t-test, 2 sided|||||||0.985332
71691170|NCT03365934|142898397|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71691171|NCT03365934|142898397|SUPERIORITY|||||||0.870459|||||||t-test, 2 sided|||||||0.870459
71691172|NCT03365934|142898397|SUPERIORITY|||||||0.004963|||||||t-test, 2 sided|||||||0.004963
71691173|NCT03365934|142898397|SUPERIORITY|||||||0.071935|||||||t-test, 2 sided|||||||0.071935
71691174|NCT03365934|142898397|SUPERIORITY|||||||0.988995|||||||t-test, 2 sided|||||||0.988995
71691175|NCT03365934|142898397|SUPERIORITY|||||||0.545378|||||||t-test, 2 sided|||||||0.545378
71691176|NCT03365934|142898397|SUPERIORITY|||||||0.000649|||||||t-test, 2 sided|||||||0.000649
71691177|NCT03365934|142898397|SUPERIORITY|||||||0.0146|||||||t-test, 2 sided|||||||0.014600
71691178|NCT03365934|142898397|SUPERIORITY|||||||0.854566|||||||t-test, 2 sided|||||||0.854566
71691179|NCT03365934|142898397|SUPERIORITY|||||||0.004322|||||||t-test, 2 sided|||||||0.004322
71691180|NCT03365934|142898397|SUPERIORITY|||||||0.0651|||||||t-test, 2 sided|||||||0.0651
71691181|NCT03365934|142898397|SUPERIORITY|||||||0.300536|||||||t-test, 2 sided|||||||0.300536
71691182|NCT03365934|142898397|SUPERIORITY|||||||0.753883|||||||t-test, 2 sided|||||||0.753883
71691183|NCT03365934|142898397|SUPERIORITY|||||||0.97621|||||||t-test, 2 sided|||||||0.97621
71691184|NCT03365934|142898398|SUPERIORITY|||||||0.027774|||||||t-test, 2 sided|||||||0.027774
71691185|NCT03365934|142898398|SUPERIORITY|||||||0.08431|||||||t-test, 2 sided|||||||0.08431
71691186|NCT03365934|142898398|SUPERIORITY|||||||0.049247|||||||t-test, 2 sided|||||||0.049247
71691187|NCT03365934|142898398|SUPERIORITY|||||||0.000126|||||||t-test, 2 sided|||||||0.000126
71691188|NCT03365934|142898398|SUPERIORITY|||||||0.010829|||||||t-test, 2 sided|||||||0.010829
71691189|NCT03365934|142898398|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691190|NCT03365934|142898398|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691191|NCT03365934|142898398|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691192|NCT03365934|142898398|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691193|NCT03365934|142898398|SUPERIORITY|||||||0.999533|||||||t-test, 2 sided|||||||0.999533
71691194|NCT03365934|142898398|SUPERIORITY|||||||0.4205363|||||||t-test, 2 sided|||||||0.4205363
71691195|NCT03365934|142898398|SUPERIORITY|||||||0.9802252|||||||t-test, 2 sided|||||||0.9802252
71691196|NCT03365934|142898398|SUPERIORITY|||||||0.6845362|||||||t-test, 2 sided|||||||0.6845362
71691197|NCT03365934|142898398|SUPERIORITY|||||||0.9992002|||||||t-test, 2 sided|||||||0.9992002
71691198|NCT03365934|142898398|SUPERIORITY|||||||0.8562779|||||||t-test, 2 sided|||||||0.8562779
71691199|NCT03365934|142898399|SUPERIORITY|||||||0.0403539|||||||t-test, 2 sided|||||||0.0403539
71691200|NCT03365934|142898399|SUPERIORITY|||||||0.2953049|||||||t-test, 2 sided|||||||0.2953049
71691201|NCT03365934|142898399|SUPERIORITY|||||||0.290551|||||||t-test, 2 sided|||||||0.290551
71935033|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.52|||||TWO_SIDED|95.0|-129.86|110.82||||||For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.82|-129.86|
71935034|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.05|||||TWO_SIDED|95.0|-117.92|79.82||||||For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||79.82|-117.92|
71691202|NCT03365934|142898399|SUPERIORITY|||||||2.47e-05|||||||t-test, 2 sided|||||||0.0000247
71691203|NCT03365934|142898399|SUPERIORITY|||||||0.0133001|||||||t-test, 2 sided|||||||0.0133001
71691204|NCT03365934|142898399|SUPERIORITY|||||||1.67e-05|||||||t-test, 2 sided|||||||0.0000167
71691205|NCT03365934|142898399|SUPERIORITY|||||||2.12e-05|||||||t-test, 2 sided|||||||0.0000212
71935035|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|-6.75|159.13||||||For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||159.13|-6.75|
71935036|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.76|||||TWO_SIDED|95.0|-64.93|55.41||||||For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||55.41|-64.93|
71691206|NCT03365934|142898399|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691207|NCT03365934|142898399|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691208|NCT03365934|142898399|SUPERIORITY|||||||0.99999995|||||||t-test, 2 sided|||||||0.99999995
71935037|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.56|||||TWO_SIDED|95.0|-271.74|260.62||||||For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||260.62|-271.74|
71691209|NCT03365934|142898399|SUPERIORITY|||||||0.0792013|||||||t-test, 2 sided|||||||0.0792013
71691210|NCT03365934|142898399|SUPERIORITY|||||||0.870163|||||||t-test, 2 sided|||||||0.870163
71691211|NCT03365934|142898399|SUPERIORITY|||||||0.103828|||||||t-test, 2 sided|||||||0.103828
71691212|NCT03365934|142898399|SUPERIORITY|||||||0.900265|||||||t-test, 2 sided|||||||0.900265
71691213|NCT03365934|142898399|SUPERIORITY|||||||0.570015|||||||t-test, 2 sided|||||||0.570015
71691214|NCT03365934|142898400|SUPERIORITY|||||||0.882449|||||||t-test, 2 sided|||||||0.882449
71691215|NCT03365934|142898400|SUPERIORITY|||||||0.088558|||||||t-test, 2 sided|||||||0.088558
71691216|NCT03365934|142898400|SUPERIORITY|||||||0.081846|||||||t-test, 2 sided|||||||0.081846
71691217|NCT03365934|142898400|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691218|NCT03365934|142898400|SUPERIORITY|||||||3.03e-05|||||||t-test, 2 sided|||||||0.0000303
71691219|NCT03365934|142898400|SUPERIORITY|||||||0.001817|||||||t-test, 2 sided|||||||0.001817
71691220|NCT03365934|142898400|SUPERIORITY|||||||0.001825|||||||t-test, 2 sided|||||||0.001825
71691221|NCT03365934|142898400|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691222|NCT03365934|142898400|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691223|NCT03365934|142898400|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
71691224|NCT03365934|142898400|SUPERIORITY|||||||0.038836|||||||t-test, 2 sided|||||||0.038836
71691225|NCT03365934|142898400|SUPERIORITY|||||||0.184508|||||||t-test, 2 sided|||||||0.184508
71691226|NCT03365934|142898400|SUPERIORITY|||||||0.062829|||||||t-test, 2 sided|||||||0.062829
71691227|NCT03365934|142898400|SUPERIORITY|||||||0.253458|||||||t-test, 2 sided|||||||0.253458
71691228|NCT03365934|142898400|SUPERIORITY|||||||0.987798|||||||t-test, 2 sided|||||||0.987798
71691229|NCT03365934|142898401|SUPERIORITY|||||||0.516068|||||||t-test, 2 sided|||||||0.516068
71691230|NCT03365934|142898401|SUPERIORITY|||||||0.358412|||||||t-test, 2 sided|||||||0.358412
71691231|NCT03365934|142898401|SUPERIORITY|||||||0.834145|||||||t-test, 2 sided|||||||0.834145
71691232|NCT03365934|142898401|SUPERIORITY|||||||3.5e-05|||||||t-test, 2 sided|||||||0.000035
71691233|NCT03365934|142898401|SUPERIORITY|||||||0.000843|||||||t-test, 2 sided|||||||0.000843
71691234|NCT03365934|142898401|SUPERIORITY|||||||0.002997|||||||t-test, 2 sided|||||||0.002997
71691235|NCT03365934|142898401|SUPERIORITY|||||||0.051717|||||||t-test, 2 sided|||||||0.051717
71691236|NCT03365934|142898401|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691237|NCT03365934|142898401|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691238|NCT03365934|142898401|SUPERIORITY|||||||0.985602|||||||t-test, 2 sided|||||||0.985602
71691239|NCT03365934|142898401|SUPERIORITY|||||||0.046422|||||||t-test, 2 sided|||||||0.046422
71691240|NCT03365934|142898401|SUPERIORITY|||||||0.28061|||||||t-test, 2 sided|||||||0.28061
71691241|NCT03365934|142898401|SUPERIORITY|||||||0.011015|||||||t-test, 2 sided|||||||0.011015
71691242|NCT03365934|142898401|SUPERIORITY|||||||0.089156|||||||t-test, 2 sided|||||||0.089156
71691243|NCT03365934|142898401|SUPERIORITY|||||||0.963882|||||||t-test, 2 sided|||||||0.963882
71691244|NCT03365934|142898402|SUPERIORITY|||||||0.00526|||||||t-test, 2 sided|||||||0.00526
71691245|NCT03365934|142898402|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71935038|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.56|||||TWO_SIDED|95.0|-166.87|197.98||||||For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||197.98|-166.87|
71935039|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.4|
71935040|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-275.22|241.89||||||For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||241.89|-275.22|
71691246|NCT03365934|142898402|SUPERIORITY|||||||0.914409|||||||t-test, 2 sided|||||||0.914409
71691247|NCT03365934|142898402|SUPERIORITY|||||||0.013004|||||||t-test, 2 sided|||||||0.013004
71691248|NCT03365934|142898402|SUPERIORITY|||||||0.028517|||||||t-test, 2 sided|||||||0.028517
71691249|NCT03365934|142898402|SUPERIORITY|||||||0.001356|||||||t-test, 2 sided|||||||0.001356
71691250|NCT03365934|142898402|SUPERIORITY|||||||5.9e-05|||||||t-test, 2 sided|||||||0.000059
71691251|NCT03365934|142898402|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691252|NCT03365934|142898402|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691253|NCT03365934|142898402|SUPERIORITY|||||||0.859272|||||||t-test, 2 sided|||||||0.859272
71691254|NCT03365934|142898402|SUPERIORITY|||||||0.002821|||||||t-test, 2 sided|||||||0.002821
71691255|NCT03365934|142898402|SUPERIORITY|||||||0.007492|||||||t-test, 2 sided|||||||0.007492
71691256|NCT03365934|142898402|SUPERIORITY|||||||0.208803|||||||t-test, 2 sided|||||||0.208803
71691257|NCT03365934|142898402|SUPERIORITY|||||||0.341884|||||||t-test, 2 sided|||||||0.341884
71691258|NCT03365934|142898402|SUPERIORITY|||||||0.999531|||||||t-test, 2 sided|||||||0.999531
71935041|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-307.94|319.05||||||For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.05|-307.94|
71935042|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-238.4|293.96||||||For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||293.96|-238.40|
71935043|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.81|||||TWO_SIDED|95.0|-215.01|244.64||||||For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||244.64|-215.01|
71691259|NCT03365934|142898403|SUPERIORITY|||||||0.066788|||||||t-test, 2 sided|||||||0.066788
71691260|NCT03365934|142898403|SUPERIORITY|||||||0.942653|||||||t-test, 2 sided|||||||0.942653
71691261|NCT03365934|142898403|SUPERIORITY|||||||0.893545|||||||t-test, 2 sided|||||||0.893545
71691262|NCT03365934|142898403|SUPERIORITY|||||||0.165225|||||||t-test, 2 sided|||||||0.165225
71691263|NCT03365934|142898403|SUPERIORITY|||||||0.140475|||||||t-test, 2 sided|||||||0.140475
71691264|NCT03365934|142898403|SUPERIORITY|||||||0.002026|||||||t-test, 2 sided|||||||0.002026
71691265|NCT03365934|142898403|SUPERIORITY|||||||0.001916|||||||t-test, 2 sided|||||||0.001916
71691266|NCT03365934|142898403|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691267|NCT03365934|142898403|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691268|NCT03365934|142898403|SUPERIORITY|||||||0.999957|||||||t-test, 2 sided|||||||0.999957
71691269|NCT03365934|142898403|SUPERIORITY|||||||0.672573|||||||t-test, 2 sided|||||||0.672573
71691270|NCT03365934|142898403|SUPERIORITY|||||||0.630145|||||||t-test, 2 sided|||||||0.630145
71691271|NCT03365934|142898403|SUPERIORITY|||||||0.832757|||||||t-test, 2 sided|||||||0.832757
71691272|NCT03365934|142898403|SUPERIORITY|||||||0.803277|||||||t-test, 1 sided|||||||0.803277
71691273|NCT03365934|142898403|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71691274|NCT03365934|142898404|SUPERIORITY|||||||0.943522|||||||t-test, 2 sided|||||||0.943522
71691275|NCT03365934|142898404|SUPERIORITY|||||||0.002376|||||||t-test, 2 sided|||||||0.002376
71691276|NCT03365934|142898404|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691277|NCT03365934|142898404|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691278|NCT03365934|142898404|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691279|NCT03365934|142898404|SUPERIORITY|||||||0.061015|||||||t-test, 2 sided|||||||0.061015
71691280|NCT03365934|142898404|SUPERIORITY|||||||0.000211|||||||t-test, 2 sided|||||||0.000211
71691281|NCT03365934|142898404|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691282|NCT03365934|142898404|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691283|NCT03365934|142898404|SUPERIORITY|||||||0.412626|||||||t-test, 2 sided|||||||0.412626
71691284|NCT03365934|142898404|SUPERIORITY|||||||0.104388|||||||t-test, 2 sided|||||||0.104388
71691285|NCT03365934|142898404|SUPERIORITY|||||||0.197791|||||||t-test, 2 sided|||||||0.197791
71691286|NCT03365934|142898404|SUPERIORITY|||||||0.994413|||||||t-test, 2 sided|||||||0.994413
71691287|NCT03365934|142898404|SUPERIORITY|||||||0.999851|||||||t-test, 2 sided|||||||0.999851
71691288|NCT03365934|142898404|SUPERIORITY|||||||0.999621|||||||t-test, 2 sided|||||||0.999621
71691289|NCT03365934|142898405|SUPERIORITY|||||||0.193667|||||||t-test, 2 sided|||||||0.193667
71691290|NCT03365934|142898405|SUPERIORITY|||||||0.526573|||||||t-test, 2 sided|||||||0.526573
71691291|NCT03365934|142898405|SUPERIORITY|||||||0.898749|||||||t-test, 2 sided|||||||0.898749
71691292|NCT03365934|142898405|SUPERIORITY|||||||0.975044|||||||t-test, 2 sided|||||||0.975044
71691293|NCT03365934|142898405|SUPERIORITY|||||||0.760706|||||||t-test, 2 sided|||||||0.760706
71691294|NCT03365934|142898405|SUPERIORITY|||||||0.985237|||||||t-test, 2 sided|||||||0.985237
71691295|NCT03365934|142898405|SUPERIORITY|||||||0.837995|||||||t-test, 2 sided|||||||0.837995
71691296|NCT03365934|142898405|SUPERIORITY|||||||0.592697|||||||t-test, 2 sided|||||||0.592697
71691297|NCT03365934|142898405|SUPERIORITY|||||||0.912495|||||||t-test, 2 sided|||||||0.912495
71691298|NCT03365934|142898405|SUPERIORITY|||||||0.99245|||||||t-test, 2 sided|||||||0.99245
71691299|NCT03365934|142898405|SUPERIORITY|||||||0.925553|||||||t-test, 2 sided|||||||0.925553
71691300|NCT03365934|142898405|SUPERIORITY|||||||0.999171|||||||t-test, 2 sided|||||||0.999171
71691301|NCT03365934|142898405|SUPERIORITY|||||||0.999324|||||||t-test, 2 sided|||||||0.999324
71691302|NCT03365934|142898405|SUPERIORITY|||||||0.999913|||||||t-test, 2 sided|||||||0.999913
71691303|NCT03365934|142898405|SUPERIORITY|||||||0.990516|||||||t-test, 2 sided|||||||0.990516
71691304|NCT03365934|142898406|SUPERIORITY|||||||0.92106|||||||t-test, 2 sided|||||||0.92106
71935044|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-302.38|324.6||||||For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||324.60|-302.38|
71935045|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-305.85|383.63||||||For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||383.63|-305.85|
71935046|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-355.85|333.63||||||For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||333.63|-355.85|
71935047|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-322.52|366.97||||||For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||366.97|-322.52|
71935048|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
71935049|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-165.61|165.61||||||For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.61|-165.61|
71935050|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|-17.84|173.39||||||For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||173.39|-17.84|
71935051|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-106.73|84.5||||||For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||84.5|-106.73|
71935052|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.17|||||TWO_SIDED|95.0|-512.66|404.33||||||For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.||404.33|-512.66|
71935053|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-70.0|||||TWO_SIDED|95.0|-143.36|3.36||||||For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.||3.36|-143.36|
71935054|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-400.13|333.46||||||For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.||333.46|-400.13|
71935055|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.67|||||TWO_SIDED|95.0|-591.86|508.53||||||For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.||508.53|-591.86|
71935056|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-66.67|||||TWO_SIDED|95.0|-66.67|-66.67||||||For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.||-66.67|-66.67|
71935057|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.33|||||TWO_SIDED|95.0|-450.13|283.46||||||For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.||283.46|-450.13|
71935058|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-177.86|311.2||||||For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.||311.2|-177.86|
71935059|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-333.46|400.13||||||For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.||400.13|-333.46|
71935060|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in pain at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
71935061|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
71935062|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
71691305|NCT03365934|142898406|SUPERIORITY|||||||0.976812|||||||t-test, 2 sided|||||||0.976812
71691306|NCT03365934|142898406|SUPERIORITY|||||||0.233992|||||||t-test, 2 sided|||||||0.233992
71691307|NCT03365934|142898406|SUPERIORITY|||||||0.007591|||||||t-test, 2 sided|||||||0.007591
71935063|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|50.0|||||TWO_SIDED|95.0|-1050.39|1150.39||||||For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.||1150.39|-1050.39|
71935064|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-1850.65|1817.32||||||For change in constipation at EoS, mean change difference was used to compare the two treatment groups.||1817.32|-1850.65|
71935065|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-700.26|766.93||||||For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.||766.93|-700.26|
71935066|NCT00219557|143391640|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.67|||||TWO_SIDED|95.0|-383.46|350.13||||||For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.||350.13|-383.46|
71935067|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.59|||||TWO_SIDED|95.0|-10.11|15.29||||||For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||15.29|-10.11|
71935068|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.41|||||TWO_SIDED|95.0|-13.39|20.2||||||For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.20|-13.39|
71935069|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.7|||||TWO_SIDED|95.0|5.96|33.43||||||For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||33.43|5.96|
71935070|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.7|||||TWO_SIDED|95.0|0.93|24.47||||||For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.47|0.93|
71935071|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1|||||TWO_SIDED|95.0|1.28|28.91||||||For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||28.91|1.28|
71935072|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.36|||||TWO_SIDED|95.0|-14.59|23.3||||||For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||23.30|-14.59|
71935073|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.19|||||TWO_SIDED|95.0|-37.53|-4.85||||||For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||-4.85|-37.53|
71935074|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.82|||||TWO_SIDED|95.0|-25.04|9.4||||||For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||9.40|-25.04|
71935075|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.95|||||TWO_SIDED|95.0|-9.59|21.5||||||For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-9.59|
71935076|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.39|||||TWO_SIDED|95.0|-1.61|30.4||||||For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||30.40|-1.61|
71935077|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|||||TWO_SIDED|95.0|2.78|22.22||||||For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||22.22|2.78|
71935078|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.88|||||TWO_SIDED|95.0|1.36|20.39||||||For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||20.39|1.36|
71935079|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|||||TWO_SIDED|95.0|-16.36|11.71||||||For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||11.71|-16.36|
71935080|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.21|||||TWO_SIDED|95.0|-11.78|24.2||||||For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.||24.20|-11.78|
71935081|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.87|||||TWO_SIDED|95.0|0.79|28.94||||||For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||28.94|0.79|
71935082|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.49|||||TWO_SIDED|95.0|-7.45|34.42||||||For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||34.42|-7.45|
71935083|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.86|||||TWO_SIDED|95.0|0.17|37.55||||||For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||37.55|0.17|
71691308|NCT03365934|142898406|SUPERIORITY|||||||0.038958|||||||t-test, 2 sided|||||||0.038958
71691309|NCT03365934|142898406|SUPERIORITY|||||||0.99809|||||||t-test, 2 sided|||||||0.99809
71935084|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.57|||||TWO_SIDED|95.0|0.66|22.48||||||For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.48|0.66|
71935085|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.72|||||TWO_SIDED|95.0|0.49|36.95||||||For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||36.95|0.49|
71935086|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|||||TWO_SIDED|95.0|-32.4|11.17||||||For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||11.17|-32.40|
71935087|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.32|||||TWO_SIDED|95.0|-14.63|17.27||||||For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.27|-14.63|
71935088|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.54|||||TWO_SIDED|95.0|-14.7|17.78||||||For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||17.78|-14.70|
71935089|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.05|||||TWO_SIDED|95.0|-10.65|32.75||||||For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||32.75|-10.65|
71935090|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4|||||TWO_SIDED|95.0|-17.33|24.13||||||For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||24.13|-17.33|
71691310|NCT03365934|142898406|SUPERIORITY|||||||0.773028|||||||t-test, 2 sided|||||||0.773028
71691311|NCT03365934|142898406|SUPERIORITY|||||||0.135805|||||||t-test, 2 sided|||||||0.135805
71691312|NCT03365934|142898406|SUPERIORITY|||||||0.350556|||||||t-test, 2 sided|||||||0.350556
71691313|NCT03365934|142898406|SUPERIORITY|||||||0.61046|||||||t-test, 2 sided|||||||0.61046
71691314|NCT03365934|142898406|SUPERIORITY|||||||0.062163|||||||t-test, 2 sided|||||||0.062163
71691315|NCT03365934|142898406|SUPERIORITY|||||||0.203418|||||||t-test, 2 sided|||||||0.203418
71691316|NCT03365934|142898406|SUPERIORITY|||||||0.942304|||||||t-test, 2 sided|||||||0.942304
71691317|NCT03365934|142898406|SUPERIORITY|||||||0.995238|||||||t-test, 2 sided|||||||0.995238
71691318|NCT03365934|142898406|SUPERIORITY|||||||0.99858|||||||t-test, 2 sided|||||||0.99858
71935091|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.27|||||TWO_SIDED|95.0|-4.4|22.93||||||For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.93|-4.40|
71935092|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.19|||||TWO_SIDED|95.0|2.99|35.39||||||For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||35.39|2.99|
71935093|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|||||TWO_SIDED|95.0|-23.7|22.43||||||For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||22.43|-23.70|
71935094|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.51|||||TWO_SIDED|95.0|-3.1|46.12||||||For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.||46.12|-3.10|
71935095|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.19|||||TWO_SIDED|95.0|-21.57|13.19||||||For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||13.19|-21.57|
71935096|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.6|||||TWO_SIDED|95.0|-32.86|7.66||||||For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||7.66|-32.86|
71935097|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.25|||||TWO_SIDED|95.0|-10.33|34.82||||||For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||34.82|-10.33|
71935098|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.84|||||TWO_SIDED|95.0|-0.18|25.85||||||For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||25.85|-0.18|
71935099|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.85|||||TWO_SIDED|95.0|-16.45|24.14||||||For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||24.14|-16.45|
71935100|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.05|||||TWO_SIDED|95.0|-23.23|37.34||||||For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||37.34|-23.23|
71691319|NCT03365934|142898407|SUPERIORITY|||||||0.998949|||||||t-test, 2 sided|||||||0.998949
71935101|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.53|||||TWO_SIDED|95.0|-26.55|21.5||||||For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||21.50|-26.55|
71691320|NCT03365934|142898407|SUPERIORITY|||||||0.111084|||||||t-test, 2 sided|||||||0.111084
71691321|NCT03365934|142898407|SUPERIORITY|||||||0.456846|||||||t-test, 2 sided|||||||0.456846
71691322|NCT03365934|142898407|SUPERIORITY|||||||0.00062|||||||t-test, 2 sided|||||||0.00062
71691323|NCT03365934|142898407|SUPERIORITY|||||||0.006871|||||||t-test, 2 sided|||||||0.006871
71691324|NCT03365934|142898407|SUPERIORITY|||||||0.039407|||||||t-test, 2 sided|||||||0.039407
71691325|NCT03365934|142898407|SUPERIORITY|||||||0.245375|||||||t-test, 2 sided|||||||0.245375
71691326|NCT03365934|142898407|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
71691327|NCT03365934|142898407|SUPERIORITY|||||||0.001612|||||||t-test, 2 sided|||||||0.001612
71691328|NCT03365934|142898407|SUPERIORITY|||||||0.988067|||||||t-test, 2 sided|||||||0.988067
71691329|NCT03365934|142898407|SUPERIORITY|||||||0.599171|||||||t-test, 2 sided|||||||0.599171
71935102|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.46|||||TWO_SIDED|95.0|-27.48|8.56||||||For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||8.56|-27.48|
71935103|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.96|||||TWO_SIDED|95.0|-30.62|16.7||||||For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||16.70|-30.62|
71935104|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.71|||||TWO_SIDED|95.0|-20.37|27.8||||||For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-20.37|
71935105|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.04|||||TWO_SIDED|95.0|-5.73|31.81||||||For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||31.81|-5.73|
71935106|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.12|||||TWO_SIDED|95.0|-3.23|33.46||||||For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||33.46|-3.23|
71935107|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.91|||||TWO_SIDED|95.0|-36.18|20.37||||||For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||20.37|-36.18|
71935108|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.38|||||TWO_SIDED|95.0|-20.24|51.01||||||For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.||51.01|-20.24|
71691330|NCT03365934|142898407|SUPERIORITY|||||||0.928722|||||||t-test, 2 sided|||||||0.928722
71691331|NCT03365934|142898407|SUPERIORITY|||||||0.256079|||||||t-test, 2 sided|||||||0.256079
71691332|NCT03365934|142898407|SUPERIORITY|||||||0.626498|||||||t-test, 2 sided|||||||0.626498
71691333|NCT03365934|142898407|SUPERIORITY|||||||0.988693|||||||t-test, 2 sided|||||||0.988693
71691334|NCT03365934|142898408|SUPERIORITY|||||||0.99916|||||||t-test, 2 sided|||||||0.99916
71691335|NCT03365934|142898408|SUPERIORITY|||||||0.016246|||||||t-test, 2 sided|||||||0.016246
71691336|NCT03365934|142898408|SUPERIORITY|||||||0.289112|||||||t-test, 2 sided|||||||0.289112
71935109|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.25|||||TWO_SIDED|95.0|-10.09|32.59||||||For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||32.59|-10.09|
71935110|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.41|||||TWO_SIDED|95.0|-25.22|40.03||||||For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||40.03|-25.22|
71691337|NCT03365934|142898408|SUPERIORITY|||||||3.8e-05|||||||t-test, 2 sided|||||||0.000038
71691338|NCT03365934|142898408|SUPERIORITY|||||||0.014558|||||||t-test, 2 sided|||||||0.014558
71691339|NCT03365934|142898408|SUPERIORITY|||||||0.03731|||||||t-test, 2 sided|||||||0.03731
71691340|NCT03365934|142898408|SUPERIORITY|||||||0.465745|||||||t-test, 2 sided|||||||0.465745
71691341|NCT03365934|142898408|SUPERIORITY|||||||0.000112|||||||t-test, 2 sided|||||||0.000112
71691342|NCT03365934|142898408|SUPERIORITY|||||||0.034575|||||||t-test, 2 sided|||||||0.034575
71691343|NCT03365934|142898408|SUPERIORITY|||||||0.889597|||||||t-test, 2 sided|||||||0.889597
71691344|NCT03365934|142898408|SUPERIORITY|||||||0.726932|||||||t-test, 2 sided|||||||0.726932
71691345|NCT03365934|142898408|SUPERIORITY|||||||0.999998|||||||t-test, 2 sided|||||||0.999998
71691346|NCT03365934|142898408|SUPERIORITY|||||||0.130235|||||||t-test, 2 sided|||||||0.130235
71691347|NCT03365934|142898408|SUPERIORITY|||||||0.910989|||||||t-test, 2 sided|||||||0.910989
71691348|NCT03365934|142898408|SUPERIORITY|||||||0.616933|||||||t-test, 2 sided|||||||0.616933
71691349|NCT03365934|142898409|SUPERIORITY|||||||0.999952|||||||t-test, 2 sided|||||||0.999952
71691350|NCT03365934|142898409|SUPERIORITY|||||||0.421347|||||||t-test, 2 sided|||||||0.421347
71691351|NCT03365934|142898409|SUPERIORITY|||||||0.598141|||||||t-test, 2 sided|||||||0.598141
71691352|NCT03365934|142898409|SUPERIORITY|||||||0.000197|||||||t-test, 2 sided|||||||0.000197
71691353|NCT03365934|142898409|SUPERIORITY|||||||0.000115|||||||t-test, 2 sided|||||||0.000115
71691354|NCT03365934|142898409|SUPERIORITY|||||||0.511155|||||||t-test, 2 sided|||||||0.511155
71691355|NCT03365934|142898409|SUPERIORITY|||||||0.693868|||||||t-test, 2 sided|||||||0.693868
71691356|NCT03365934|142898409|SUPERIORITY|||||||0.000232|||||||t-test, 2 sided|||||||0.000232
71691357|NCT03365934|142898409|SUPERIORITY|||||||0.000133|||||||t-test, 2 sided|||||||0.000133
71691358|NCT03365934|142898409|SUPERIORITY|||||||0.999894|||||||t-test, 2 sided|||||||0.999894
71691359|NCT03365934|142898409|SUPERIORITY|||||||0.078046|||||||t-test, 2 sided|||||||0.078046
71691360|NCT03365934|142898409|SUPERIORITY|||||||0.054975|||||||t-test, 2 sided|||||||0.054975
71691361|NCT03365934|142898409|SUPERIORITY|||||||0.050132|||||||t-test, 2 sided|||||||0.050132
71691362|NCT03365934|142898409|SUPERIORITY|||||||0.034793|||||||t-test, 2 sided|||||||0.034793
71691363|NCT03365934|142898409|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
71691364|NCT03365934|142898410|SUPERIORITY|||||||0.997406|||||||t-test, 2 sided|||||||0.997406
71691365|NCT03365934|142898410|SUPERIORITY|||||||0.354187|||||||t-test, 2 sided|||||||0.354187
71691366|NCT03365934|142898410|SUPERIORITY|||||||0.883222|||||||t-test, 2 sided|||||||0.883222
71935111|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.28|||||TWO_SIDED|95.0|4.23|52.32||||||For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||52.32|4.23|
71935112|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.22|||||TWO_SIDED|95.0|5.09|43.34||||||For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||43.34|5.09|
71935113|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.11|||||TWO_SIDED|95.0|-0.16|50.38||||||For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||50.38|-0.16|
71935114|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.07|||||TWO_SIDED|95.0|-47.95|27.8||||||For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||27.80|-47.95|
71935115|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.61|||||TWO_SIDED|95.0|-21.78|14.57||||||For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||14.57|-21.78|
71935116|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.98|||||TWO_SIDED|95.0|-17.02|28.99||||||For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||28.99|-17.02|
71935117|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.08|||||TWO_SIDED|95.0|-5.39|49.55||||||For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||49.55|-5.39|
71935118|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.78|||||TWO_SIDED|95.0|-15.33|34.89||||||For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||34.89|-15.33|
71935119|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.81|||||TWO_SIDED|95.0|-10.43|42.06||||||For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.06|-10.43|
71935120|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.77|||||TWO_SIDED|95.0|1.11|42.43||||||For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||42.43|1.11|
71935121|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.81|||||TWO_SIDED|95.0|-41.91|12.28||||||For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||12.28|-41.91|
71935122|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.11|||||TWO_SIDED|95.0|1.6|60.62||||||For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.||60.62|1.60|
71935123|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|||||TWO_SIDED|95.0|-20.62|38.1||||||For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||38.10|-20.62|
71935124|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||||TWO_SIDED|95.0|-68.52|42.05||||||For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.05|-68.52|
71935125|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|||||TWO_SIDED|95.0|-7.93|52.05||||||For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||52.05|-7.93|
71935126|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.63|||||TWO_SIDED|95.0|-5.64|42.89||||||For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||42.89|-5.64|
71935127|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.96|||||TWO_SIDED|95.0|-9.93|57.84||||||For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||57.84|-9.93|
71691367|NCT03365934|142898410|SUPERIORITY|||||||0.000412|||||||t-test, 2 sided|||||||0.000412
71935128|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.54|||||TWO_SIDED|95.0|-32.7|59.78||||||For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.78|-32.70|
71935129|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.14|||||TWO_SIDED|95.0|-29.46|55.74||||||For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||55.74|-29.46|
71935130|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.37|||||TWO_SIDED|95.0|-24.04|36.79||||||For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||36.79|-24.04|
71935131|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.59|||||TWO_SIDED|95.0|-17.94|59.12||||||For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.12|-17.94|
71935132|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.29|||||TWO_SIDED|95.0|-20.12|40.71||||||For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||40.71|-20.12|
71935133|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.74|||||TWO_SIDED|95.0|-8.22|59.69||||||For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||59.69|-8.22|
71935134|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.56|||||TWO_SIDED|95.0|5.32|71.81||||||For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||71.81|5.32|
71935135|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.44|||||TWO_SIDED|95.0|-53.14|44.25||||||For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||44.25|-53.14|
71935136|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.17|||||TWO_SIDED|95.0|-69.9|61.57||||||For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.||61.57|-69.90|
71935137|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-24.52|50.45||||||For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||50.45|-24.52|
71935138|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.15|||||TWO_SIDED|95.0|-76.41|30.11||||||For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||30.11|-76.41|
71935139|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.44|||||TWO_SIDED|95.0|-71.89|33.0||||||For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||33.00|-71.89|
71935140|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|7.31|87.13||||||For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||87.13|7.31|
71935141|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|41.67|||||TWO_SIDED|95.0|-36.0|119.34||||||For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||119.34|-36.00|
71935142|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-5.05|82.83||||||For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||82.83|-5.05|
71935143|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.14|||||TWO_SIDED|95.0|-2.09|66.37||||||For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-2.09|
71935144|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-44.46|29.64||||||For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||29.64|-44.46|
71935145|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.96|||||TWO_SIDED|95.0|-40.45|66.37||||||For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||66.37|-40.45|
71935146|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-32.71|60.49||||||For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||60.49|-32.71|
71935147|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.86|||||TWO_SIDED|95.0|-16.16|77.89||||||For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||77.89|-16.16|
71691368|NCT03365934|142898410|SUPERIORITY|||||||0.000332|||||||t-test, 2 sided|||||||0.000332
71691369|NCT03365934|142898410|SUPERIORITY|||||||0.626878|||||||t-test, 2 sided|||||||0.626878
71935148|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.83|||||TWO_SIDED|95.0|-44.95|86.62||||||For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||86.62|-44.95|
71935149|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.52|||||TWO_SIDED|95.0|-115.22|78.19||||||For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.||78.19|-115.22|
71935150|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.46|||||TWO_SIDED|95.0|-39.71|86.63||||||For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||86.63|-39.71|
71935151|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.96|||||TWO_SIDED|95.0|-130.69|104.76||||||For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||104.76|-130.69|
71935152|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|48.15|||||TWO_SIDED|95.0|-7.12|103.42||||||For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.42|-7.12|
71935153|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|92.59|||||TWO_SIDED|95.0|63.16|122.02||||||For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||122.02|63.16|
71935154|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-85.03|96.14||||||For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.14|-85.03|
71935155|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|37.04|||||TWO_SIDED|95.0|-29.46|103.54||||||For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.54|-29.46|
71691370|NCT03365934|142898410|SUPERIORITY|||||||0.984465|||||||t-test, 2 sided|||||||0.984465
71935156|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.14|||||TWO_SIDED|95.0|-41.45|27.16||||||For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||27.16|-41.45|
71935157|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-67.04|59.64||||||For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||59.64|-67.04|
71935158|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|||||TWO_SIDED|95.0|-104.79|89.97||||||For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||89.97|-104.79|
71935159|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.22|||||TWO_SIDED|95.0|-58.8|103.25||||||For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||103.25|-58.80|
71935160|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-36.28|91.83||||||For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||91.83|-36.28|
71935161|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-74.3|96.52||||||For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||96.52|-74.30|
71935162|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-29.17|||||TWO_SIDED|95.0|-142.55|84.21||||||For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||84.21|-142.55|
71935163|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-55.56|||||TWO_SIDED|95.0|-212.46|101.35||||||For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.||101.35|-212.46|
71935164|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-62.93|96.26||||||For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.26|-62.93|
71935165|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-87.74|116.31||||||For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||116.31|-87.74|
71935166|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|73.81|||||TWO_SIDED|95.0|7.9|139.72||||||For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||139.72|7.90|
71935167|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|76.19|||||TWO_SIDED|95.0|33.64|118.74||||||For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||118.74|33.64|
71935168|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.57|||||TWO_SIDED|95.0|-64.64|121.79||||||For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||121.79|-64.64|
71935169|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|35.71|||||TWO_SIDED|95.0|-28.11|99.53||||||For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||99.53|-28.11|
71935170|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.33|||||TWO_SIDED|95.0|-104.01|77.34||||||For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||77.34|-104.01|
71935171|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-44.44|||||TWO_SIDED|95.0|-140.03|51.14||||||For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||51.14|-140.03|
71935172|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.76|||||TWO_SIDED|95.0|-88.45|97.98||||||For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||97.98|-88.45|
71935173|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.29|||||TWO_SIDED|95.0|-54.32|82.89||||||For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||82.89|-54.32|
71935174|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.81|||||TWO_SIDED|95.0|-66.45|114.07||||||For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||114.07|-66.45|
71935175|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.75|||||TWO_SIDED|95.0|-56.14|119.63||||||For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||119.63|-56.14|
71935176|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-50.0|||||TWO_SIDED|95.0|-163.35|63.35||||||For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||63.35|-163.35|
71935177|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.29|||||TWO_SIDED|95.0|-125.23|96.66||||||For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.||96.66|-125.23|
71935178|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
71935179|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-45.18|95.18||||||For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||95.18|-45.18|
71935180|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|77.78|||||TWO_SIDED|95.0|14.55|141.0||||||For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||141.00|14.55|
71935181|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|86.11|||||TWO_SIDED|95.0|40.61|131.61||||||For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||131.61|40.61|
71935182|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-56.48|106.48||||||For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||106.48|-56.48|
71935183|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|47.22|||||TWO_SIDED|95.0|-37.69|132.13||||||For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||132.13|-37.69|
71935184|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.0|||||TWO_SIDED|95.0|-70.68|110.68||||||For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||110.68|-70.68|
71935185|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.33|||||TWO_SIDED|95.0|-91.87|25.2||||||For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||25.20|-91.87|
71935186|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|||||TWO_SIDED|95.0|-41.89|97.45||||||For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||97.45|-41.89|
71691371|NCT03365934|142898410|SUPERIORITY|||||||0.001845|||||||t-test, 2 sided|||||||0.001845
71691372|NCT03365934|142898410|SUPERIORITY|||||||0.001507|||||||t-test, 2 sided|||||||0.001507
71935187|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.67|||||TWO_SIDED|95.0|-34.03|67.36||||||For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||67.36|-34.03|
71935188|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-100.19|116.86||||||For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||116.86|-100.19|
71691373|NCT03365934|142898410|SUPERIORITY|||||||0.970029|||||||t-test, 2 sided|||||||0.970029
71935189|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.93|||||TWO_SIDED|95.0|-53.73|105.58||||||For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||105.58|-53.73|
71935190|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-117.07|117.07||||||For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.||117.07|-117.07|
71935191|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.89|||||TWO_SIDED|95.0|-221.53|249.31||||||For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||249.31|-221.53|
71935192|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.56|||||TWO_SIDED|95.0|-260.62|271.74||||||For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||271.74|-260.62|
71935193|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|66.67|||||TWO_SIDED|95.0|-152.41|285.75||||||For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||285.75|-152.41|
71935194|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|100.0|||||TWO_SIDED|95.0|-119.08|319.08||||||For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||319.08|-119.08|
71935195|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.33|||||TWO_SIDED|95.0|-185.75|252.41||||||For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||252.41|-185.75|
71935196|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-82.04|170.93||||||For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||170.93|-82.04|
71935197|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
71935198|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.11|||||TWO_SIDED|95.0|-202.34|180.12||||||For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||180.12|-202.34|
71935199|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
71935200|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.11|||||TWO_SIDED|95.0|-84.5|106.73||||||For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||106.73|-84.50|
71935201|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.89|||||TWO_SIDED|95.0|-87.6|165.37||||||For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||165.37|-87.60|
71935202|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|44.44|||||TWO_SIDED|95.0|-208.53|297.42||||||For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||297.42|-208.53|
71935203|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.22|||||TWO_SIDED|95.0|-275.19|230.75||||||For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.||230.75|-275.19|
71935204|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|58.33|||||TWO_SIDED|95.0|-491.86|608.53||||||For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.||608.53|-491.86|
71935205|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|25.0|||||TWO_SIDED|95.0|-1258.79|1308.79||||||For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.||1308.79|-1258.79|
71935206|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
71935207|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.33|||||TWO_SIDED|95.0|-175.06|191.73||||||For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.||191.73|-175.06|
71935208|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in ascites at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
71935209|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-733.59|733.59||||||For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.||733.59|-733.59|
71935210|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|83.33|||||TWO_SIDED|95.0|-283.46|450.13||||||For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.||450.13|-283.46|
71935211|NCT00219557|143391641|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.56|||||TWO_SIDED|95.0|-1375.5|1436.61||||||For change in side effects at EoS, mean change difference was used to compare the two treatment groups.||1436.61|-1375.5|
71935212|NCT02741271|143391667|SUPERIORITY||LSM Difference|5.21|||<|0.001|TWO_SIDED|95.0|3.21|7.2|||cLDA with multiple imputation|Primary Analysis Method, using the constrained Longitudinal Data Analysis (cLDA) model for missing data|Between-Treatment Difference|||7.20|3.21|<0.001
71935213|NCT02741271|143391670|SUPERIORITY||LSM Difference|6.05|||<|0.001|TWO_SIDED|95.0|3.53|8.56|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 4 hr Post-Dose|||8.56|3.53|<0.001
71935214|NCT02741271|143391670|SUPERIORITY||LSM Difference|7.04|||<|0.001|TWO_SIDED|95.0|4.74|9.35|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 2 hr Post-Dose|||9.35|4.74|<0.001
71935215|NCT02741271|143391670|SUPERIORITY||LSM Difference|6.19|||<|0.001|TWO_SIDED|95.0|4.09|8.28|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 60 min Post-Dose|||8.28|4.09|<0.001
71935216|NCT02741271|143391670|SUPERIORITY||LSM Difference|6.89|||<|0.001|TWO_SIDED|95.0|5.1|8.67|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 30 min Post-Dose|||8.67|5.10|<0.001
71935217|NCT02741271|143391670|SUPERIORITY||LSM Difference|6.64|||<|0.001|TWO_SIDED|95.0|4.89|8.39|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 15 min Post-Dose|||8.39|4.89|<0.001
71935218|NCT02741271|143391670|SUPERIORITY||LSM Difference|4.2|||<|0.001|TWO_SIDED|95.0|2.5|5.91|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 5 min Post-Dose|||5.91|2.50|<0.001
71935219|NCT02741271|143391671|SUPERIORITY||LSM Difference|6.32|||<|0.001|TWO_SIDED|95.0|4.36|8.27|||cLDA|Secondary Outcome Measure on Day 1|Between-Treatment Difference at 4 hr Post-Dose|||8.27|4.36|<0.001
71935220|NCT02741271|143391671|SUPERIORITY||LSM Difference|3.33||||0.026|TWO_SIDED|95.0|0.41|6.26|||cLDA|Secondary Outcome Measure at Week 12|Between-Treatment Difference at 4 hr Post-Dose|||6.26|0.41|0.026
71935221|NCT02741271|143391672|SUPERIORITY||LSM Difference|1.63||||0.197|TWO_SIDED|95.0|-0.85|4.11|||cLDA|Secondary Outcome Measure|Between-Treatment Difference|||4.11|-0.85|0.197
71935222|NCT00410410|143391682|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.124|TWO_SIDED|95.0|0.48|1.09||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata (whether a participant had an inadequate response and/or intolerance to anti-TNF therapy).|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 mg/kg vs PLA comparison being statistically significant at 5% level, ABA \~10 vs PLA to be tested at 5% significance level.||Null hypothesis=no treatment difference between ABA arm and placebo (PLA) arm. ABA 30/\~10 mg/kg vs PLA: power=98%, sample size=140 per arm,expected PLA response rate=40%, ABA 30/\~10 mg/kg=65%. ABA \~10 mg/kg vs. PLA: power=90%, sample size=140 per arm, 5% significance; expected PLA response rate= 40%, ABA \~10=60%.||1.09|0.48|0.124
71935223|NCT00410410|143391684|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.2|||||TWO_SIDED|95.0|0.06|0.67||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|Conditional on ABA 30/\~10 vs PLA comparison for clinical response being significant at 5% level, this comparison for remission will be tested at 5%.|Conditional on both the remission comparison for ABA 30/\~10 vs PLA, and the clinical response comparison for ABA\~10 vs PLA being significant at 5%, the secondary remission comparison for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference between each of the ABA and placebo (PLA). At 5% significance level, Aba 30/\~10 vs. PLA: power=96%, sample size=140 per arm, expected PLA rate=15%. ABA 30/\~10 =35%; Aba \~10 vs. PLA: power=82%, sample size=140 per arm, expected PLA response rate= 15%, ABA/\~10 mg/kg=30%||0.67|.06|
71691374|NCT03365934|142898410|SUPERIORITY|||||||0.19886|||||||t-test, 2 sided|||||||0.19886
71691375|NCT03365934|142898410|SUPERIORITY|||||||0.177549|||||||t-test, 2 sided|||||||0.177549
71691376|NCT03365934|142898410|SUPERIORITY|||||||0.041698|||||||t-test, 2 sided|||||||0.041698
71691377|NCT03365934|142898410|SUPERIORITY|||||||0.036131|||||||t-test, 2 sided|||||||0.036131
71691378|NCT03365934|142898410|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71691379|NCT03365934|142898411|SUPERIORITY|||||||1|||||||t-test, 2 sided|||||||1
71691380|NCT03365934|142898411|SUPERIORITY|||||||0.317315|||||||t-test, 2 sided|||||||0.317315
71691381|NCT03365934|142898411|SUPERIORITY|||||||0.829352|||||||t-test, 2 sided|||||||0.829352
71691382|NCT03365934|142898411|SUPERIORITY|||||||0.010561|||||||t-test, 2 sided|||||||0.010561
71691383|NCT03365934|142898411|SUPERIORITY|||||||0.001099|||||||t-test, 2 sided|||||||0.001099
71691384|NCT03365934|142898411|SUPERIORITY|||||||0.175148|||||||t-test, 2 sided|||||||0.175148
71691385|NCT03365934|142898411|SUPERIORITY|||||||0.728796|||||||t-test, 2 sided|||||||0.728796
71691386|NCT03365934|142898411|SUPERIORITY|||||||0.001992|||||||t-test, 2 sided|||||||0.001992
71691387|NCT03365934|142898411|SUPERIORITY|||||||0.000113|||||||t-test, 2 sided|||||||0.000113
71691388|NCT03365934|142898411|SUPERIORITY|||||||0.974567|||||||t-test, 2 sided|||||||0.974567
71691389|NCT03365934|142898411|SUPERIORITY|||||||0.668933|||||||t-test, 2 sided|||||||0.668933
71691390|NCT03365934|142898411|SUPERIORITY|||||||0.239446|||||||t-test, 2 sided|||||||0.239446
71691391|NCT03365934|142898411|SUPERIORITY|||||||0.283848|||||||t-test, 2 sided|||||||0.283848
71691392|NCT03365934|142898411|SUPERIORITY|||||||0.06829|||||||t-test, 2 sided|||||||0.06829
71691393|NCT03365934|142898411|SUPERIORITY|||||||0.979516|||||||t-test, 2 sided|||||||0.979516
71691394|NCT03365934|142898412|SUPERIORITY|||||||0.996522|||||||t-test, 2 sided|||||||0.996522
71691395|NCT03365934|142898412|SUPERIORITY|||||||0.875832|||||||t-test, 2 sided|||||||0.875832
71691396|NCT03365934|142898412|SUPERIORITY|||||||0.938|||||||t-test, 2 sided|||||||0.938
71691397|NCT03365934|142898412|SUPERIORITY|||||||0.038527|||||||t-test, 2 sided|||||||0.038527
71691398|NCT03365934|142898412|SUPERIORITY|||||||0.018334|||||||t-test, 2 sided|||||||0.018334
71691399|NCT03365934|142898412|SUPERIORITY|||||||0.512209|||||||t-test, 2 sided|||||||0.512209
71691400|NCT03365934|142898412|SUPERIORITY|||||||0.665529|||||||t-test, 2 sided|||||||0.665529
71691401|NCT03365934|142898412|SUPERIORITY|||||||0.002257|||||||t-test, 2 sided|||||||0.002257
71691402|NCT03365934|142898412|SUPERIORITY|||||||0.000728|||||||t-test, 2 sided|||||||0.000728
71691403|NCT03365934|142898412|SUPERIORITY|||||||0.999993|||||||t-test, 2 sided|||||||0.999993
71691404|NCT03365934|142898412|SUPERIORITY|||||||0.417914|||||||t-test, 2 sided|||||||0.417914
71691405|NCT03365934|142898412|SUPERIORITY|||||||0.277469|||||||t-test, 2 sided|||||||0.277469
71691406|NCT03365934|142898412|SUPERIORITY|||||||0.385419|||||||t-test, 2 sided|||||||0.385419
71691407|NCT03365934|142898412|SUPERIORITY|||||||0.257647|||||||t-test, 2 sided|||||||0.257647
71691408|NCT03365934|142898412|SUPERIORITY|||||||0.999897|||||||t-test, 2 sided|||||||0.999897
71691409|NCT03365934|142898413|SUPERIORITY|||||||0.862516|||||||t-test, 2 sided|||||||0.862516
71691410|NCT03365934|142898413|SUPERIORITY|||||||0.00473|||||||t-test, 2 sided|||||||0.00473
71691411|NCT03365934|142898413|SUPERIORITY|||||||0.085238|||||||t-test, 2 sided|||||||0.085238
71691412|NCT03365934|142898413|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691413|NCT03365934|142898413|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71691414|NCT03365934|142898413|SUPERIORITY|||||||0.168409|||||||t-test, 2 sided|||||||0.168409
71691415|NCT03365934|142898413|SUPERIORITY|||||||0.652654|||||||t-test, 2 sided|||||||0.652654
71691416|NCT03365934|142898413|SUPERIORITY|||||||0.001436|||||||t-test, 2 sided|||||||0.001436
71691417|NCT03365934|142898413|SUPERIORITY|||||||0.000235|||||||t-test, 2 sided|||||||0.000235
71691418|NCT03365934|142898413|SUPERIORITY|||||||0.974842|||||||t-test, 2 sided|||||||0.974842
71691419|NCT03365934|142898413|SUPERIORITY|||||||0.557877|||||||t-test, 2 sided|||||||0.557877
71691420|NCT03365934|142898413|SUPERIORITY|||||||0.277244|||||||t-test, 2 sided|||||||0.277244
71691421|NCT03365934|142898413|SUPERIORITY|||||||0.195527|||||||t-test, 2 sided|||||||0.195527
71691422|NCT03365934|142898413|SUPERIORITY|||||||0.070843|||||||t-test, 2 sided|||||||0.070843
71691423|NCT03365934|142898413|SUPERIORITY|||||||0.997565|||||||t-test, 2 sided|||||||0.997565
71691424|NCT03365934|142898414|SUPERIORITY|||||||0.016628|||||||t-test, 2 sided|||||||0.016628
71691425|NCT03365934|142898414|SUPERIORITY|||||||0.217862|||||||t-test, 2 sided|||||||0.217862
71691426|NCT03365934|142898414|SUPERIORITY|||||||0.812915|||||||t-test, 2 sided|||||||0.812915
71691427|NCT03365934|142898414|SUPERIORITY|||||||0.999971|||||||t-test, 2 sided|||||||0.999971
71691428|NCT03365934|142898414|SUPERIORITY|||||||0.275557|||||||t-test, 2 sided|||||||0.275557
71691429|NCT03365934|142898414|SUPERIORITY|||||||0.870124|||||||t-test, 2 sided|||||||0.870124
71691430|NCT03365934|142898414|SUPERIORITY|||||||0.380144|||||||t-test, 2 sided|||||||0.380144
71935224|NCT00410410|143391685|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66|||||TWO_SIDED|95.0|0.42|1.05||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata.|Cochran-Mantel-Haenszel|If ABA 30/\~10 vs PLA remission comparison is significant at 5% level, the mucosal healing comparison for the same treatment group will be tested at 5%|Conditional on both the comparison for mucosal healing for ABA 30/\~10 vs PLA and the comparison for remission for ABA \~10 vs. PLA being significant, the comparison for mucosal healing for ABA \~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference (relative risk \[RR\] of ABA over placebo=1) for mucosal healing. ABA 30/\~10 vs. placebo: power=99%, sample size=140 per arm, expected PLA response rate=30%, ABA 30/\~10 mg/kg=60%. ABA \~10 vs. placebo: power=98%, sample size=140 per arm, 5% significance; expected PLA response rate= 30%, ABA \~10 mg/kg=55%||1.05|0.42|
71935225|NCT00410410|143391686|SUPERIORITY_OR_OTHER|||||||0.044||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms.||||0.044
71935226|NCT00410410|143391692|SUPERIORITY_OR_OTHER|||||||0.149||||||All statistical testing was performed at a pre-specified alpha-level of 5%|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.||||0.149
71935227|NCT02868281|143391749|OTHER||Odds Ratio (OR)|7.87||||0.027|TWO_SIDED|95.0|1.29|48.11|||Mixed effect logistic regression||The model included treatment, Baseline ACT total score, Baseline ACT total score squared, center, type of Baseline controller, gender and age, with the center as a random factor.|||48.11|1.29|0.027
71935228|NCT02868281|143391750|OTHER||Difference in Least Squares Mean|-0.1||||0.222|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.222
71935229|NCT02868281|143391750|OTHER||Difference in Least Squares Mean|-0.1||||0.156|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.156
71935230|NCT02868281|143391750|OTHER||Difference in Least Squares Mean|-0.1||||0.245|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.245
71935231|NCT02868281|143391750|OTHER||Difference in Least Squares Mean|-0.1||||0.057|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.057
71935232|NCT02868281|143391750|OTHER||Difference in Least Squares Mean|-0.1||||0.151|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.151
71691431|NCT03365934|142898414|SUPERIORITY|||||||0.029518|||||||t-test, 2 sided|||||||0.029518
71935233|NCT02868281|143391750|OTHER||Difference in Least Squares Mean|-0.1||||0.114|TWO_SIDED|95.0|-0.2|0.0|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.0|-0.2|0.114
71935234|NCT02868281|143391751|OTHER||Difference in Least Squares Mean|-0.05||||0.487|TWO_SIDED|95.0|-0.18|0.09|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.18|0.487
71935235|NCT02868281|143391751|OTHER||Difference in Least Squares Mean|-0.04||||0.546|TWO_SIDED|95.0|-0.16|0.09|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.09|-0.16|0.546
71935236|NCT02868281|143391751|OTHER||Difference in Least Squares Mean|-0.06||||0.314|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.314
71935237|NCT02868281|143391751|OTHER||Difference in Least Squares Mean|-0.07||||0.197|TWO_SIDED|95.0|-0.19|0.04|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.04|-0.19|0.197
71935238|NCT02868281|143391751|OTHER||Difference in Least Squares Mean|-0.06||||0.282|TWO_SIDED|95.0|-0.17|0.06|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.06|-0.17|0.282
71935239|NCT02868281|143391751|OTHER||Difference in Least Squares Mean|-0.03||||0.543|TWO_SIDED|95.0|-0.15|0.08|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||0.08|-0.15|0.543
71935240|NCT02868281|143391752|OTHER||Difference in Least Squares Mean|0.06||||0.273|TWO_SIDED|95.0|-0.059|0.18|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline FEV1, type of Baseline controller, gender and age, with the center as a random factor.|||0.180|-0.059|0.273
71691432|NCT03365934|142898414|SUPERIORITY|||||||0.815476|||||||t-test, 2 sided|||||||0.815476
71691433|NCT03365934|142898414|SUPERIORITY|||||||0.944307|||||||t-test, 2 sided|||||||0.944307
71691434|NCT03365934|142898414|SUPERIORITY|||||||0.313389|||||||t-test, 2 sided|||||||0.313389
71691435|NCT03365934|142898414|SUPERIORITY|||||||0.999996|||||||t-test, 2 sided|||||||0.999996
71691436|NCT03365934|142898414|SUPERIORITY|||||||0.894272|||||||t-test, 2 sided|||||||0.894272
71691437|NCT03365934|142898414|SUPERIORITY|||||||0.969093|||||||t-test, 2 sided|||||||0.969093
71691438|NCT03365934|142898414|SUPERIORITY|||||||0.383434|||||||t-test, 2 sided|||||||0.383434
71691439|NCT03365934|142898415|SUPERIORITY|||||||0.393119|||||||t-test, 2 sided|||||||0.393119
71691440|NCT03365934|142898415|SUPERIORITY|||||||0.890335|||||||t-test, 2 sided|||||||0.890335
71691441|NCT03365934|142898415|SUPERIORITY|||||||0.021978|||||||t-test, 2 sided|||||||0.021978
71691442|NCT03365934|142898415|SUPERIORITY|||||||0.000983|||||||t-test, 2 sided|||||||0.000983
71691443|NCT03365934|142898415|SUPERIORITY|||||||0.006615|||||||t-test, 2 sided|||||||0.006615
71691444|NCT03365934|142898415|SUPERIORITY|||||||0.951883|||||||t-test, 2 sided|||||||0.951883
71691445|NCT03365934|142898415|SUPERIORITY|||||||0.692455|||||||t-test, 2 sided|||||||0.692455
71691446|NCT03365934|142898415|SUPERIORITY|||||||0.257254|||||||t-test, 2 sided|||||||0.257254
71935241|NCT02868281|143391753|OTHER||Difference in Least Squares Mean|-12.0||||0.367|TWO_SIDED|95.0|-40.3|16.3|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.3|-40.3|0.367
71691447|NCT03365934|142898415|SUPERIORITY|||||||0.530181|||||||t-test, 2 sided|||||||0.530181
71691448|NCT03365934|142898415|SUPERIORITY|||||||0.219274|||||||t-test, 2 sided|||||||0.219274
71691449|NCT03365934|142898415|SUPERIORITY|||||||0.029675|||||||t-test, 2 sided|||||||0.029675
71691450|NCT03365934|142898415|SUPERIORITY|||||||0.111454|||||||t-test, 2 sided|||||||0.111454
71691451|NCT03365934|142898415|SUPERIORITY|||||||0.995849|||||||t-test, 2 sided|||||||0.995849
71691452|NCT03365934|142898415|SUPERIORITY|||||||0.999994|||||||t-test, 2 sided|||||||0.999994
71691453|NCT03365934|142898415|SUPERIORITY|||||||0.998744|||||||t-test, 2 sided|||||||0.998744
71691454|NCT03365934|142898416|SUPERIORITY|||||||0.999858|||||||t-test, 2 sided|||||||0.999858
71691455|NCT03365934|142898416|SUPERIORITY|||||||0.215132|||||||t-test, 2 sided|||||||0.215132
71691456|NCT03365934|142898416|SUPERIORITY|||||||0.958812|||||||t-test, 2 sided|||||||0.958812
71691457|NCT03365934|142898416|SUPERIORITY|||||||0.00622|||||||t-test, 2 sided|||||||0.00622
71691458|NCT03365934|142898416|SUPERIORITY|||||||0.017733|||||||t-test, 2 sided|||||||0.017733
71691459|NCT03365934|142898416|SUPERIORITY|||||||0.330576|||||||t-test, 2 sided|||||||0.330576
71691460|NCT03365934|142898416|SUPERIORITY|||||||0.990334|||||||t-test, 2 sided|||||||0.990334
71691461|NCT03365934|142898416|SUPERIORITY|||||||0.013025|||||||t-test, 2 sided|||||||0.013025
71691462|NCT03365934|142898416|SUPERIORITY|||||||0.034707|||||||t-test, 2 sided|||||||0.034707
71691463|NCT03365934|142898416|SUPERIORITY|||||||0.771698|||||||t-test, 2 sided|||||||0.771698
71691464|NCT03365934|142898416|SUPERIORITY|||||||0.790117|||||||t-test, 2 sided|||||||0.790117
71691465|NCT03365934|142898416|SUPERIORITY|||||||0.923224|||||||t-test, 2 sided|||||||0.923224
71691466|NCT03365934|142898416|SUPERIORITY|||||||0.112245|||||||t-test, 2 sided|||||||0.112245
71691467|NCT03365934|142898416|SUPERIORITY|||||||0.216229|||||||t-test, 2 sided|||||||0.216229
71691468|NCT03365934|142898416|SUPERIORITY|||||||0.999663|||||||t-test, 2 sided|||||||0.999663
71691469|NCT03365934|142898417|SUPERIORITY|||||||0.91874|||||||t-test, 2 sided|||||||0.91874
71691470|NCT03365934|142898417|SUPERIORITY|||||||0.013582|||||||t-test, 2 sided|||||||0.013582
71691471|NCT03365934|142898417|SUPERIORITY|||||||0.523284|||||||t-test, 2 sided|||||||0.523284
71691472|NCT03365934|142898417|SUPERIORITY|||||||0.000315|||||||t-test, 2 sided|||||||0.000315
71691473|NCT03365934|142898417|SUPERIORITY|||||||0.059485|||||||t-test, 2 sided|||||||0.059485
71691474|NCT03365934|142898417|SUPERIORITY|||||||0.15037|||||||t-test, 2 sided|||||||0.15037
71691475|NCT03365934|142898417|SUPERIORITY|||||||0.967277|||||||t-test, 2 sided|||||||0.967277
71691476|NCT03365934|142898417|SUPERIORITY|||||||0.008729|||||||t-test, 2 sided|||||||0.008729
71691477|NCT03365934|142898417|SUPERIORITY|||||||0.421603|||||||t-test, 2 sided|||||||0.421603
71691478|NCT03365934|142898417|SUPERIORITY|||||||0.647267|||||||t-test, 2 sided|||||||0.647267
71691479|NCT03365934|142898417|SUPERIORITY|||||||0.953645|||||||t-test, 2 sided|||||||0.953645
71691480|NCT03365934|142898417|SUPERIORITY|||||||0.987387|||||||t-test, 2 sided|||||||0.987387
71691481|NCT03365934|142898417|SUPERIORITY|||||||0.147361|||||||t-test, 2 sided|||||||0.147361
71691482|NCT03365934|142898417|SUPERIORITY|||||||0.930371|||||||t-test, 2 sided|||||||0.930371
71691483|NCT03365934|142898417|SUPERIORITY|||||||0.6094|||||||t-test, 2 sided|||||||0.6094
71691484|NCT03365934|142898418|SUPERIORITY|||||||0.99253|||||||t-test, 2 sided|||||||0.99253
71691485|NCT03365934|142898418|SUPERIORITY|||||||0.795279|||||||t-test, 2 sided|||||||0.795279
71691486|NCT03365934|142898418|SUPERIORITY|||||||0.855067|||||||t-test, 2 sided|||||||0.855067
71691487|NCT03365934|142898418|SUPERIORITY|||||||0.003915|||||||t-test, 2 sided|||||||0.003915
71691488|NCT03365934|142898418|SUPERIORITY|||||||0.000221|||||||t-test, 2 sided|||||||0.000221
71691489|NCT03365934|142898418|SUPERIORITY|||||||0.97816|||||||t-test, 2 sided|||||||0.97816
71691490|NCT03365934|142898418|SUPERIORITY|||||||0.98972|||||||t-test, 2 sided|||||||0.98972
71691491|NCT03365934|142898418|SUPERIORITY|||||||0.01764|||||||t-test, 2 sided|||||||0.01764
71691492|NCT03365934|142898418|SUPERIORITY|||||||0.001185|||||||t-test, 2 sided|||||||0.001185
71691493|NCT03365934|142898418|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
71691494|NCT03365934|142898418|SUPERIORITY|||||||0.119961|||||||t-test, 2 sided|||||||0.119961
71691495|NCT03365934|142898418|SUPERIORITY|||||||0.013468|||||||t-test, 2 sided|||||||0.013468
71935242|NCT02868281|143391753|OTHER||Difference in Least Squares Mean|-7.2||||0.587|TWO_SIDED|95.0|-35.5|21.2|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.2|-35.5|0.587
71935243|NCT02868281|143391753|OTHER||Difference in Least Squares Mean|-4.7||||0.721|TWO_SIDED|95.0|-33.1|23.7|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.7|-33.1|0.721
71935244|NCT02868281|143391753|OTHER||Difference in Least Squares Mean|-3.3||||0.801|TWO_SIDED|95.0|-31.7|25.1|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.1|-31.7|0.801
71935245|NCT02868281|143391753|OTHER||Difference in Least Squares Mean|-5.0||||0.704|TWO_SIDED|95.0|-33.3|23.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||23.4|-33.3|0.704
71935246|NCT02868281|143391753|OTHER||Difference in Least Squares Mean|-4.0||||0.762|TWO_SIDED|95.0|-32.4|24.5|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-32.4|0.762
71935247|NCT02868281|143391754|OTHER||Difference in Least Squares Mean|-12.8||||0.354|TWO_SIDED|95.0|-42.1|16.5|||Mixed Model Repeat Measures||Weeks 1-4. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||16.5|-42.1|0.354
71935248|NCT02868281|143391754|OTHER||Difference in Least Squares Mean|-8.4||||0.538|TWO_SIDED|95.0|-37.8|21.0|||Mixed Model Repeat Measures||Weeks 5-8. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||21.0|-37.8|0.538
71935249|NCT02868281|143391754|OTHER||Difference in Least Squares Mean|-5.0||||0.716|TWO_SIDED|95.0|-34.4|24.5|||Mixed Model Repeat Measures||Weeks 9-12. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||24.5|-34.4|0.716
71935250|NCT02868281|143391754|OTHER||Difference in Least Squares Mean|-3.1||||0.822|TWO_SIDED|95.0|-32.5|26.3|||Mixed Model Repeat Measures||Weeks 13-16. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||26.3|-32.5|0.822
71935251|NCT02868281|143391754|OTHER||Difference in Least Squares Mean|-4.0||||0.767|TWO_SIDED|95.0|-33.4|25.4|||Mixed Model Repeat Measures||Weeks 17-20. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.4|-33.4|0.767
71935252|NCT02868281|143391754|OTHER||Difference in Least Squares Mean|-3.8||||0.779|TWO_SIDED|95.0|-33.4|25.7|||Mixed Model Repeat Measures||Weeks 21-24. The model included covariates of treatment, center, Baseline ACT total score, type of Baseline controller, gender, age and treatment-by-visit interaction, with the center as a random factor.|||25.7|-33.4|0.779
71691496|NCT03365934|142898418|SUPERIORITY|||||||0.112192|||||||t-test, 2 sided|||||||0.112192
71935253|NCT02868281|143391755|OTHER||Difference in Least Squares Mean|0.3||||0.059|TWO_SIDED|95.0|0.0|0.6|||Mixed Model Repeat Measures||The model included covariates of treatment, center, Baseline AQLQ(S) score, type of Baseline controller, gender and age, with the center as a random factor.|||0.6|-0.0|0.059
71935254|NCT02868281|143391756|OTHER||Hazard Ratio (HR)|1.843||||0.01|TWO_SIDED|95.0|1.16|2.926|||Cox proportional hazards model||The model included treatment, Baseline ACT total score, center, type of Baseline controller, gender and age as covariates.|||2.926|1.160|0.010
71935255|NCT02868281|143391757|OTHER||Rate Ratio|1.09||||0.897|TWO_SIDED|95.0|0.32|3.73|||Generalised linear model||The model included treatment, Baseline ACT total score, type of Baseline controller, gender and age as covariates.|||3.73|0.32|0.897
71935256|NCT01841359|143391777|OTHER|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||||||0.90
71935257|NCT01841359|143391778|OTHER|||||||0.08|||||||t-test, 2 sided|||||||0.08
71935258|NCT01841359|143391779|OTHER||||||=|0.20492|||||||t-test, 2 sided|||||||= 0.20492
71691497|NCT03365934|142898418|SUPERIORITY|||||||0.013135|||||||t-test, 2 sided|||||||0.013135
71691498|NCT03365934|142898418|SUPERIORITY|||||||0.965966|||||||t-test, 2 sided|||||||0.965966
71691499|NCT03365934|142898419|SUPERIORITY|||||||0.968005|||||||t-test, 2 sided|||||||0.968005
71935259|NCT01841359|143391780|OTHER|||||||0.2655|||||||t-test, 2 sided|||||||0.2655
71935260|NCT01841359|143391781|OTHER|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71935261|NCT01841359|143391782|OTHER|||||||0.597|||||||t-test, 2 sided|||||||0.597
71935262|NCT01841359|143391783|OTHER|||||||0.37|||||||t-test, 2 sided|||||||0.37
71935263|NCT01841359|143391784|OTHER|||||||0.14|||||||t-test, 2 sided|||||||0.14
71935264|NCT01841359|143391785|OTHER|||||||0.412|||||||t-test, 2 sided|||||||0.412
71935265|NCT01841359|143391786|OTHER|||||||0.89|||||||t-test, 2 sided|||||||0.890
71935266|NCT01841359|143391787|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
71935267|NCT02151461|143391788|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in plasma glucose AUC(0-3hr) at Week 4 in the Day 28 Evaluable population. The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.0435||||||Baseline plasma glucose AUC(0-3hr) is adjusted as a covariate.|ANCOVA|||||||0.0435
71935268|NCT02151461|143391788|OTHER|||||||0.065|||||||ANCOVA|||||||0.065
71935269|NCT02151461|143391788|OTHER|||||||0.1216|||||||ANCOVA|||||||0.1216
71935270|NCT02151461|143391789|OTHER|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in incremental plasma glucose AUC at Week 4 in the Day 28 Evaluable population. The model will include factors for treatment group and fasting plasma glucose stratum.||||||0.8867|||||||ANCOVA|The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.8867
71935271|NCT02151461|143391789|OTHER|||||||0.7641|||||||ANCOVA|||||||0.7641
71691500|NCT03365934|142898419|SUPERIORITY|||||||0.526293|||||||t-test, 2 sided|||||||0.526293
71691501|NCT03365934|142898419|SUPERIORITY|||||||0.994384|||||||t-test, 2 sided|||||||0.994384
71691502|NCT03365934|142898419|SUPERIORITY|||||||0.004967|||||||t-test, 2 sided|||||||0.004967
71691503|NCT03365934|142898419|SUPERIORITY|||||||0.000948|||||||t-test, 2 sided|||||||0.000948
71691504|NCT03365934|142898419|SUPERIORITY|||||||0.936394|||||||t-test, 2 sided|||||||0.936394
71691505|NCT03365934|142898419|SUPERIORITY|||||||0.999945|||||||t-test, 2 sided|||||||0.999945
71691506|NCT03365934|142898419|SUPERIORITY|||||||0.050032|||||||t-test, 2 sided|||||||0.050032
71691507|NCT03365934|142898419|SUPERIORITY|||||||0.01256|||||||t-test, 2 sided|||||||0.01256
71691508|NCT03365934|142898419|SUPERIORITY|||||||0.886978|||||||t-test, 2 sided|||||||0.886978
71935272|NCT02151461|143391789|OTHER|||||||0.2518|||||||ANCOVA|||||||0.2518
71691509|NCT03365934|142898419|SUPERIORITY|||||||0.391295|||||||t-test, 2 sided|||||||0.391295
71691510|NCT03365934|142898419|SUPERIORITY|||||||0.163678|||||||t-test, 2 sided|||||||0.163678
71691511|NCT03365934|142898419|SUPERIORITY|||||||0.047937|||||||t-test, 2 sided|||||||0.047937
71691512|NCT03365934|142898419|SUPERIORITY|||||||0.013231|||||||t-test, 2 sided|||||||0.013231
71691513|NCT03365934|142898419|SUPERIORITY|||||||0.996358|||||||t-test, 2 sided|||||||0.996358
71691514|NCT03365934|142898420|SUPERIORITY|||||||0.995862|||||||t-test, 2 sided|||||||0.995862
71691515|NCT03365934|142898420|SUPERIORITY|||||||0.223341|||||||t-test, 2 sided|||||||0.223341
71691516|NCT03365934|142898420|SUPERIORITY|||||||0.834338|||||||t-test, 2 sided|||||||0.834338
71691517|NCT03365934|142898420|SUPERIORITY|||||||0.030267|||||||t-test, 2 sided|||||||0.030267
71691518|NCT03365934|142898420|SUPERIORITY|||||||0.00104|||||||t-test, 2 sided|||||||0.00104
71691519|NCT03365934|142898420|SUPERIORITY|||||||0.377217|||||||t-test, 2 sided|||||||0.377217
71691520|NCT03365934|142898420|SUPERIORITY|||||||0.965547|||||||t-test, 2 sided|||||||0.965547
71935273|NCT02151461|143391790|OTHER|||||||0.0179|||||||ANCOVA|Total daily dose is twice the respective dose, Pairwise comparison using Treatment D as the reference group||||||0.0179
71935274|NCT02151461|143391790|OTHER|||||||0.0736|||||||ANCOVA|||||||0.0736
71935275|NCT02151461|143391790|OTHER|||||||0.0475|||||||ANCOVA|||||||0.0475
71691521|NCT03365934|142898420|SUPERIORITY|||||||0.052284|||||||t-test, 2 sided|||||||0.052284
71691522|NCT03365934|142898420|SUPERIORITY|||||||0.001348|||||||t-test, 2 sided|||||||0.001348
71691523|NCT03365934|142898420|SUPERIORITY|||||||0.927936|||||||t-test, 2 sided|||||||0.927936
71691524|NCT03365934|142898420|SUPERIORITY|||||||0.946487|||||||t-test, 2 sided|||||||0.946487
71691525|NCT03365934|142898420|SUPERIORITY|||||||0.327918|||||||t-test, 2 sided|||||||0.327918
71691526|NCT03365934|142898420|SUPERIORITY|||||||0.475038|||||||t-test, 2 sided|||||||0.475038
71691527|NCT03365934|142898420|SUPERIORITY|||||||0.060057|||||||t-test, 2 sided|||||||0.060057
71691528|NCT03365934|142898420|SUPERIORITY|||||||0.857177|||||||t-test, 2 sided|||||||0.857177
71691529|NCT03365934|142898421|SUPERIORITY|||||||0.999997|||||||t-test, 2 sided|||||||0.999997
71691530|NCT03365934|142898421|SUPERIORITY|||||||0.938793|||||||t-test, 2 sided|||||||0.938793
71691531|NCT03365934|142898421|SUPERIORITY|||||||0.965993|||||||t-test, 2 sided|||||||0.965993
71691532|NCT03365934|142898421|SUPERIORITY|||||||0.057803|||||||t-test, 2 sided|||||||0.057803
71691533|NCT03365934|142898421|SUPERIORITY|||||||0.022816|||||||t-test, 2 sided|||||||0.022816
71691534|NCT03365934|142898421|SUPERIORITY|||||||0.945179|||||||t-test, 2 sided|||||||0.945179
71691535|NCT03365934|142898421|SUPERIORITY|||||||0.972522|||||||t-test, 2 sided|||||||0.972522
71691536|NCT03365934|142898421|SUPERIORITY|||||||0.033704|||||||t-test, 2 sided|||||||0.033704
71691537|NCT03365934|142898421|SUPERIORITY|||||||0.010747|||||||t-test, 2 sided|||||||0.010747
71691538|NCT03365934|142898421|SUPERIORITY|||||||0.999999|||||||t-test, 2 sided|||||||0.999999
71691539|NCT03365934|142898421|SUPERIORITY|||||||0.385474|||||||t-test, 2 sided|||||||0.385474
71691540|NCT03365934|142898421|SUPERIORITY|||||||0.213798|||||||t-test, 2 sided|||||||0.213798
71691541|NCT03365934|142898421|SUPERIORITY|||||||0.388682|||||||t-test, 2 sided|||||||0.388682
71691542|NCT03365934|142898421|SUPERIORITY|||||||0.22386|||||||t-test, 2 sided|||||||0.22386
71691543|NCT03365934|142898421|SUPERIORITY|||||||0.999494|||||||t-test, 2 sided|||||||0.999494
71691544|NCT03365934|142898422|SUPERIORITY|||||||0.891244|||||||t-test, 2 sided|||||||0.891244
71691545|NCT03365934|142898422|SUPERIORITY|||||||0.022659|||||||t-test, 2 sided|||||||0.022659
71691546|NCT03365934|142898422|SUPERIORITY|||||||0.693615|||||||t-test, 2 sided|||||||0.693615
71691547|NCT03365934|142898422|SUPERIORITY|||||||0.000237|||||||t-test, 2 sided|||||||0.000237
71691548|NCT03365934|142898422|SUPERIORITY|||||||5e-06|||||||t-test, 2 sided|||||||0.000005
71691549|NCT03365934|142898422|SUPERIORITY|||||||0.352008|||||||t-test, 2 sided|||||||0.352008
71691550|NCT03365934|142898422|SUPERIORITY|||||||0.998761|||||||t-test, 2 sided|||||||0.998761
71691551|NCT03365934|142898422|SUPERIORITY|||||||0.017832|||||||t-test, 2 sided|||||||0.017832
71691552|NCT03365934|142898422|SUPERIORITY|||||||0.000974|||||||t-test, 2 sided|||||||0.000974
71691553|NCT03365934|142898422|SUPERIORITY|||||||0.638238|||||||t-test, 2 sided|||||||0.638238
71691554|NCT03365934|142898422|SUPERIORITY|||||||0.777423|||||||t-test, 2 sided|||||||0.777423
71691555|NCT03365934|142898422|SUPERIORITY|||||||0.249909|||||||t-test, 2 sided|||||||0.249909
71691556|NCT03365934|142898422|SUPERIORITY|||||||0.068196|||||||t-test, 2 sided|||||||0.068196
71691557|NCT03365934|142898422|SUPERIORITY|||||||0.005786|||||||t-test, 2 sided|||||||0.005786
71935276|NCT02151461|143391791|OTHER|||||||0.0089|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||||||0.0089
71935277|NCT02151461|143391791|OTHER|||||||0.376|||||||ANCOVA|||||||0.376
71935278|NCT02151461|143391791|OTHER|||||||0.0578|||||||ANCOVA|||||||0.0578
71691558|NCT03365934|142898422|SUPERIORITY|||||||0.954163|||||||t-test, 2 sided|||||||0.954163
71691559|NCT03365934|142898424|SUPERIORITY||Mean Difference (Net)|-7.5|STANDARD_ERROR_OF_MEAN|2.851||0.009|TWO_SIDED|95.0|-13.1279|-1.8688|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||-1.8688|-13.1279|0.009
71691560|NCT03365934|142898424|SUPERIORITY||Mean Difference (Net)|-5.08|STANDARD_ERROR_OF_MEAN|2.851||0.077|TWO_SIDED|95.0|-10.7083|0.5508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||0.5508|-10.7083|0.077
71691561|NCT03365934|142898424|SUPERIORITY||Mean Difference (Net)|-2.41|STANDARD_ERROR_OF_MEAN|2.851||0.399|TWO_SIDED|95.0|-8.0399|3.2192|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||3.2192|-8.0399|0.399
71935279|NCT02151461|143391792|OTHER|||||||0.2177|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||The HOMA Calculator,is an algorithm that takes account of variations in hepatic and peripheral glucose resistance, increases in insulin secretion curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and contribution of circulating proinsulin (eg, C-peptide) to estimate steady state beta cell function (%HOMA-B) and insulin sensitivity (%HOMA-S), as percentages of a normal reference population. %HOMA-IR was analyzed on a logarithmic scale (natural logarithmic transformation).||||0.2177
71935280|NCT02151461|143391792|OTHER|||||||0.4144|||||||ANCOVA|||||||0.4144
71935281|NCT02151461|143391792|OTHER|||||||0.3117|||||||ANCOVA|||||||0.3117
71935282|NCT02151461|143391793|OTHER|Average Change in Pre-meal Glucose Level||||||0.011|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.011
71935283|NCT02151461|143391793|OTHER|Average Change in Pre-meal Glucose Level||||||0.0152|||||||ANCOVA|||||||0.0152
71935284|NCT02151461|143391793|OTHER|Average Change in Pre-meal Glucose Level||||||0.0284|||||||ANCOVA|||||||0.0284
71935285|NCT02151461|143391793|OTHER|Average Change in Post-meal Glucose Level||||||0.1273|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.1273
71935286|NCT02151461|143391793|OTHER|Average Change in Post-meal Glucose Level||||||0.0085|||||||ANCOVA|||||||0.0085
71935287|NCT02151461|143391793|OTHER|Average Change in Post-meal Glucose Level||||||0.1289|||||||ANCOVA|||||||0.1289
71935288|NCT02151461|143391794|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.3143|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise comparison using Treatment D as the reference group.||||||0.3143
71935289|NCT02151461|143391794|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.5677|||||||ANCOVA|||||||0.5677
71935290|NCT02151461|143391794|OTHER|Plasma Insulin Absolute AUC(0-2hr) (h\*uIU/mL)||||||0.8407|||||||ANCOVA|||||||0.8407
71935291|NCT02151461|143391795|OTHER|||||||0.9789|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group||||||0.9789
71935292|NCT02151461|143391795|OTHER|||||||0.841|||||||ANCOVA|||||||0.841
71935293|NCT02151461|143391795|OTHER|||||||0.748|||||||ANCOVA|||||||0.748
71935294|NCT01102777|143391800|SUPERIORITY_OR_OTHER|||||||0.142|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.||||||0.142
71935295|NCT01102777|143391801|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||.502
71935296|NCT01102777|143391802|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.90
71935297|NCT01102777|143391803|SUPERIORITY_OR_OTHER|||||||0.93|TWO_SIDED||||||Regression, Linear|Adjusted for baseline value and rural residence.||||||.93
71935298|NCT01102777|143391804|SUPERIORITY_OR_OTHER|||||||0.08|TWO_SIDED||||||Zero inflated Poisson regression|Adjusted for age, gender, oxygen use, and arm.||||||.08
71935299|NCT01102777|143391805|SUPERIORITY_OR_OTHER|||||||0.731|TWO_SIDED||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group\*time interaction, MMRC score, and urban versus rural residence.||||||0.731
71935300|NCT01102777|143391806|SUPERIORITY_OR_OTHER|||||||0.52|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.52
71935301|NCT01102777|143391807|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|||||||||The determination of arm occurred after recruitment, and Study Reach is a recruitment value.||||
71935302|NCT01102777|143391808|SUPERIORITY_OR_OTHER|||||||0.11|||||||Regression, Linear|Adjusting for time, MMRC score, and urban versus rural residence.||||||.11
71935303|NCT01102777|143391809|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.||||||.01
71935304|NCT01965652|143391814|SUPERIORITY_OR_OTHER||LS Mean Difference|1.28|STANDARD_ERROR_OF_MEAN|0.226|<|0.0001|TWO_SIDED|95.0|0.83|1.72||The significance level was set at 0.05 (2-sided). The analysis of efficacy endpoints was not adjusted for multiplicity; hence, the p-values are purely nominal. A mixed-effects model repeated measures (MMRM) method was used for the comparisons.|Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||1.72|0.83|<0.0001
71935305|NCT01965652|143391814|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.24|<|0.0001|TWO_SIDED|95.0|0.53|1.47|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||1.47|0.53|<0.0001
71935306|NCT01965652|143391814|SUPERIORITY_OR_OTHER||LS Mean Difference|1.01|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|0.52|1.5|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||1.50|0.52|<0.0001
71935307|NCT01965652|143391814|SUPERIORITY_OR_OTHER||LS Mean Difference|1.0|STANDARD_ERROR_OF_MEAN|0.259||0.0001|TWO_SIDED|95.0|0.49|1.51|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||1.51|0.49|0.0001
71935308|NCT01965652|143391816|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001|TWO_SIDED|95.0|-0.44|-0.25|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.25|-0.44|<0.0001
71935309|NCT01965652|143391816|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.36|<0.0001
71935310|NCT01965652|143391816|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.29|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.4|-0.18|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.18|-0.40|<0.0001
71691562|NCT03365934|142898424|SUPERIORITY||Mean Difference (Net)|0.72|STANDARD_ERROR_OF_MEAN|2.851||0.802|TWO_SIDED|95.0|-4.9144|6.3446|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||6.3446|-4.9144|0.802
71691563|NCT03365934|142898425|SUPERIORITY||Mean Difference (Net)|-11.37|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-17.3738|-5.3723|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||-5.3723|-17.3738|<0.001
71691564|NCT03365934|142898425|SUPERIORITY||Mean Difference (Net)|-12.68|STANDARD_ERROR_OF_MEAN|3.038|<|0.001|TWO_SIDED|95.0|-18.6789|-6.6775|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-6.6775|-18.6789|<0.001
71691565|NCT03365934|142898425|SUPERIORITY||Mean Difference (Net)|-1.96|STANDARD_ERROR_OF_MEAN|3.038||0.521|TWO_SIDED|95.0|-7.9571|4.0444|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||4.0444|-7.9571|0.521
71691566|NCT03365934|142898425|SUPERIORITY||Mean Difference (Net)|8.39|STANDARD_ERROR_OF_MEAN|3.038||0.006|TWO_SIDED|95.0|2.3925|14.394|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||14.3940|2.3925|0.006
71691567|NCT03365934|142898426|SUPERIORITY||Mean Difference (Net)|-31.83|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-41.3967|-22.2538|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||-22.2538|-41.3967|<0.001
71691568|NCT03365934|142898426|SUPERIORITY||Mean Difference (Net)|-27.3|STANDARD_ERROR_OF_MEAN|4.847|<|0.001|TWO_SIDED|95.0|-36.8727|-17.7298|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-17.7298|-36.8727|<0.001
71691569|NCT03365934|142898426|SUPERIORITY||Mean Difference (Net)|-13.71|STANDARD_ERROR_OF_MEAN|4.847||0.005|TWO_SIDED|95.0|-23.2784|-4.1355|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||-4.1355|-23.2784|0.005
71691570|NCT03365934|142898426|SUPERIORITY||Mean Difference (Net)|10.07|STANDARD_ERROR_OF_MEAN|4.847||0.039|TWO_SIDED|95.0|0.4969|19.6398|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||19.6398|0.4969|0.039
71691571|NCT03365934|142898427|SUPERIORITY||Mean Difference (Net)|-40.39|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-51.0324|-29.7496|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-29.7496|-51.0324|<0.001
71691572|NCT03365934|142898427|SUPERIORITY||Mean Difference (Net)|-37.84|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-48.4787|-27.1959|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-27.1959|-48.4787|<0.001
71691573|NCT03365934|142898427|SUPERIORITY||Mean Difference (Net)|-20.99|STANDARD_ERROR_OF_MEAN|5.39|<|0.001|TWO_SIDED|95.0|-31.6336|-10.3508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||-10.3508|-31.6336|<0.001
71691574|NCT03365934|142898427|SUPERIORITY||Mean Difference (Net)|8.75|STANDARD_ERROR_OF_MEAN|5.39||0.106|TWO_SIDED|95.0|-1.8871|19.3957|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||19.3957|-1.8871|0.106
71691575|NCT03365934|142898428|SUPERIORITY||Mean Difference (Net)|-32.9|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-43.3249|-22.4838|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-22.4838|-43.3249|<0.001
71691576|NCT03365934|142898428|SUPERIORITY||Mean Difference (Net)|-27.31|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-37.7279|-16.8868|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-16.8868|-37.7279|<0.001
71691577|NCT03365934|142898428|SUPERIORITY||Mean Difference (Net)|-18.76|STANDARD_ERROR_OF_MEAN|5.276|<|0.001|TWO_SIDED|95.0|-29.1785|-8.3374|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-8.3374|-29.1785|<0.001
71691578|NCT03365934|142898428|SUPERIORITY||Mean Difference (Net)|6.79|STANDARD_ERROR_OF_MEAN|5.276||0.2|TWO_SIDED|95.0|-3.6303|17.2107|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||17.2107|-3.6303|0.200
71691579|NCT03365934|142898429|SUPERIORITY||Mean Difference (Net)|-30.9|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-39.5325|-22.265|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-22.2650|-39.5325|<0.001
71691580|NCT03365934|142898429|SUPERIORITY||Mean Difference (Net)|-25.33|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-33.9669|-16.6993|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-16.6993|-33.9669|<0.001
71691581|NCT03365934|142898429|SUPERIORITY||Mean Difference (Net)|-20.63|STANDARD_ERROR_OF_MEAN|4.371|<|0.001|TWO_SIDED|95.0|-29.2588|-11.9912|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-11.9912|-29.2588|<0.001
71691582|NCT03365934|142898429|SUPERIORITY||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|4.371||0.33|TWO_SIDED|95.0|-4.362|12.9055|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||12.9055|-4.3620|0.330
71691583|NCT03365934|142898430|SUPERIORITY||Mean Difference (Net)|-13.95|STANDARD_ERROR_OF_MEAN|3.754|<|0.001|TWO_SIDED|95.0|-21.368|-6.5419|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-6.5419|-21.3680|<0.001
71691584|NCT03365934|142898430|SUPERIORITY||Mean Difference (Net)|-11.54|STANDARD_ERROR_OF_MEAN|3.754||0.002|TWO_SIDED|95.0|-18.9563|-4.1302|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-4.1302|-18.9563|0.002
71935311|NCT01965652|143391816|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.47|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.24|-0.47|<0.0001
71935312|NCT01965652|143391816|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.35|-0.12|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.12|-0.35|<0.0001
71935313|NCT01965652|143391817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.054||0.0002|TWO_SIDED|95.0|-0.31|-0.1|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.10|-0.31|0.0002
71935314|NCT01965652|143391817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0173|TWO_SIDED|95.0|-0.26|-0.03|||Mixed-effects model repeated meaures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.03|-0.26|0.0173
71935315|NCT01965652|143391817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.061||0.0035|TWO_SIDED|95.0|-0.3|-0.06|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.06|-0.30|0.0035
71935316|NCT01965652|143391817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.4|-0.16|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.16|-0.40|<0.0001
71935317|NCT01965652|143391817|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.064||0.0336|TWO_SIDED|95.0|-0.26|-0.01|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.01|-0.26|0.0336
71935318|NCT01965652|143391818|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.37|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.37|<0.0001
71935319|NCT01965652|143391818|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.063||0.0114|TWO_SIDED|95.0|-0.28|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.04|-0.28|0.0114
71935320|NCT01965652|143391818|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.065||0.0003|TWO_SIDED|95.0|-0.36|-0.11|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.11|-0.36|0.0003
71935321|NCT01965652|143391818|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.38|-0.13|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.13|-0.38|<0.0001
71935322|NCT01965652|143391818|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.066||0.0119|TWO_SIDED|95.0|-0.29|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.04|-0.29|0.0119
71935323|NCT01965652|143391819|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.64|-0.39|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.39|-0.64|<0.0001
71935324|NCT01965652|143391819|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|-0.51|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.51|<0.0001
71935325|NCT01965652|143391819|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.54|-0.27|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.27|-0.54|<0.0001
71935326|NCT01965652|143391819|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.071|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.34|-0.62|<0.0001
71935327|NCT01965652|143391819|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.37|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.52|-0.23|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.23|-0.52|<0.0001
71935328|NCT01965652|143391820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.047|<|0.0001|TWO_SIDED|95.0|-0.49|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.30|-0.49|<0.0001
71935329|NCT01965652|143391820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.46|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.26|-0.46|<0.0001
71935330|NCT01965652|143391820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.43|-0.22|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.22|-0.43|<0.0001
71935331|NCT01965652|143391820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.29|-0.50|<0.0001
71691585|NCT03365934|142898430|SUPERIORITY||Mean Difference (Net)|-10.07|STANDARD_ERROR_OF_MEAN|3.754||0.008|TWO_SIDED|95.0|-17.4867|-2.6606|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-2.6606|-17.4867|0.008
71935332|NCT01965652|143391820|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.42|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.20|-0.42|<0.0001
71935333|NCT01965652|143391821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|-0.5|-0.28|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.28|-0.50|<0.0001
71935334|NCT01965652|143391821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.063|<|0.0001|TWO_SIDED|95.0|-0.44|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Anaysis||-0.20|-0.44|<0.0001
71935335|NCT01965652|143391821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|0.065|<|0.0001|TWO_SIDED|95.0|-0.4|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.15|-0.40|<0.0001
71935336|NCT01965652|143391821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.34|STANDARD_ERROR_OF_MEAN|0.068|<|0.0001|TWO_SIDED|95.0|-0.48|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.21|-0.48|<0.0001
71935337|NCT01965652|143391821|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.067|<|0.0001|TWO_SIDED|95.0|-0.41|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.15|-0.41|<0.0001
71935338|NCT01965652|143391822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|-0.34|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.14|-0.34|<0.0001
71935339|NCT01965652|143391822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.055|<|0.0001|TWO_SIDED|95.0|-0.35|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.14|-0.35|<0.0001
71935340|NCT01965652|143391822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.25|STANDARD_ERROR_OF_MEAN|0.057|<|0.0001|TWO_SIDED|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.14|-0.36|<0.0001
71935341|NCT01965652|143391822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.059|<|0.0001|TWO_SIDED|95.0|-0.43|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.19|-0.43|<0.0001
71935342|NCT01965652|143391822|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.21|STANDARD_ERROR_OF_MEAN|0.061||0.0006|TWO_SIDED|95.0|-0.33|-0.09|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.09|-0.33|0.0006
71935343|NCT01965652|143391823|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.39|STANDARD_ERROR_OF_MEAN|0.054|<|0.0001|TWO_SIDED|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.29|-0.50|<0.0001
71935344|NCT01965652|143391823|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.36|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.48|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.24|-0.48|<0.0001
71935345|NCT01965652|143391823|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.061|<|0.0001|TWO_SIDED|95.0|-0.45|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.21|-0.45|<0.0001
71935346|NCT01965652|143391823|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.062|<|0.0001|TWO_SIDED|95.0|-0.54|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.30|-0.54|<0.0001
71691586|NCT03365934|142898430|SUPERIORITY||Mean Difference (Net)|6.87|STANDARD_ERROR_OF_MEAN|3.754||0.069|TWO_SIDED|95.0|-0.5447|14.2814|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||14.2814|-0.5447|0.069
71691587|NCT03365934|142898431|SUPERIORITY||Mean Difference (Net)|-2.76|STANDARD_ERROR_OF_MEAN|3.244||0.397|TWO_SIDED|95.0|-9.1631|3.6504|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||3.6504|-9.1631|0.397
71935347|NCT01965652|143391823|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.064|<|0.0001|TWO_SIDED|95.0|-0.44|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.19|-0.44|<0.0001
71935348|NCT01965652|143391824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001|TWO_SIDED|95.0|-0.81|-0.53|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis||-0.53|-0.81|<0.0001
71935349|NCT01965652|143391824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|0.075|<|0.0001|TWO_SIDED|95.0|-0.73|-0.43|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis||-0.43|-0.73|<0.0001
71935350|NCT01965652|143391824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.077|<|0.0001|TWO_SIDED|95.0|-0.66|-0.36|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis||-0.36|-0.66|<0.0001
71935351|NCT01965652|143391824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.08|<|0.0001|TWO_SIDED|95.0|-0.69|-0.38|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis||-0.38|-0.69|<0.0001
71935352|NCT01965652|143391824|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.64|-0.32|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis||-0.32|-0.64|<0.0001
71935353|NCT01965652|143391825|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71935354|NCT01121900|143391826|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 80% and 125%.|Mean ratio|39.8|||||TWO_SIDED|90.0|34.4|46.0|||||Test/reference (%)|||46.0|34.4|
71691588|NCT03365934|142898431|SUPERIORITY||Mean Difference (Net)|0.81|STANDARD_ERROR_OF_MEAN|3.244||0.804|TWO_SIDED|95.0|-5.6006|7.2129|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||7.2129|-5.6006|0.804
71691589|NCT03365934|142898431|SUPERIORITY||Mean Difference (Net)|-9.32|STANDARD_ERROR_OF_MEAN|3.244||0.005|TWO_SIDED|95.0|-15.7231|-2.9096|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-2.9096|-15.7231|0.005
71691590|NCT03365934|142898431|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|3.244||0.985|TWO_SIDED|95.0|-6.3452|6.4683|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||6.4683|-6.3452|0.985
71691591|NCT03365934|142898433|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.044||0.348|TWO_SIDED|95.0|-0.129|0.0458|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1||0.0458|-0.1290|0.348
71691592|NCT03365934|142898433|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.044||0.019|TWO_SIDED|95.0|-0.1904|-0.0178|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1||-0.0178|-0.1904|0.019
71691593|NCT03365934|142898433|SUPERIORITY||Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.043||0.183|TWO_SIDED|95.0|-0.1437|0.0278|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1||0.0278|-0.1437|0.183
71691594|NCT03365934|142898433|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.044||0.736|TWO_SIDED|95.0|-0.0725|0.1023|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1||0.1023|-0.0725|0.736
71691595|NCT03365934|142898434|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.052||0.516|TWO_SIDED|95.0|-0.136|0.0687|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2||0.0687|-0.1360|0.516
71691596|NCT03365934|142898434|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.052||0.006|TWO_SIDED|95.0|-0.2459|-0.0412|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2||-0.0412|-0.2459|0.006
71691597|NCT03365934|142898434|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.051||0.671|TWO_SIDED|95.0|-0.1235|0.0798|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2||0.0798|-0.1235|0.671
71691598|NCT03365934|142898434|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.052||0.004|TWO_SIDED|95.0|0.0504|0.2578|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2||0.2578|0.0504|0.004
71691599|NCT03365934|142898435|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.062||0.292|TWO_SIDED|95.0|-0.1896|0.0579|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3||0.0579|-0.1896|0.292
71691600|NCT03365934|142898435|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.062||0.016|TWO_SIDED|95.0|-0.2773|-0.0297|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3||-0.0297|-0.2773|0.016
71691601|NCT03365934|142898435|SUPERIORITY||Mean Difference (Net)|-0.04|STANDARD_ERROR_OF_MEAN|0.062||0.538|TWO_SIDED|95.0|-0.1622|0.0853|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3||0.0853|-0.1622|0.538
71691602|NCT03365934|142898435|SUPERIORITY||Mean Difference (Net)|0.012|STANDARD_ERROR_OF_MEAN|0.065||0.061|TWO_SIDED|95.0|-0.0059|0.2515|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3||0.2515|-0.0059|0.061
71691603|NCT03365934|142898436|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.06||0.001|TWO_SIDED|95.0|-0.3265|-0.0895|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4||-0.0895|-0.3265|0.001
71691604|NCT03365934|142898436|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.06|<|0.001|TWO_SIDED|95.0|-0.3614|-0.1243|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4||-0.1243|-0.3614|<0.001
71691605|NCT03365934|142898436|SUPERIORITY||Mean Difference (Net)|-0.07|STANDARD_ERROR_OF_MEAN|0.06||0.236|TWO_SIDED|95.0|-0.1899|0.0471|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4||0.0471|-0.1899|0.236
71691606|NCT03365934|142898436|SUPERIORITY||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.061||0.627|TWO_SIDED|95.0|-0.0902|0.1492|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4||0.1492|-0.0902|0.627
71691607|NCT03365934|142898437|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.051|<|0.001|TWO_SIDED|95.0|-0.3331|-0.1305|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5||-0.1305|-0.3331|<0.001
71691608|NCT03365934|142898437|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3091|-0.1092|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5||-0.1092|-0.3091|<0.001
71691609|NCT03365934|142898437|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.05||0.005|TWO_SIDED|95.0|-0.2439|-0.0457|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5||-0.0457|-0.2439|0.005
71691610|NCT03365934|142898437|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.052||0.02|TWO_SIDED|95.0|0.0197|0.2252|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5||0.2252|0.0197|0.020
71691611|NCT03365934|142898438|SUPERIORITY||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.4019|-0.2044|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6||-0.2044|-0.4019|<0.001
71935355|NCT01121900|143391827|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-tlast) is between 80% and 125%.|Mean ratio|80.9|||||TWO_SIDED|90.0|74.2|88.3|||||Test/reference (%)|||88.3|74.2|
71935356|NCT01121900|143391828|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|83.5|||||TWO_SIDED|90.0|76.5|91.1|||||Test/reference (%)|||91.1|76.5|
71935357|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.31|STANDARD_ERROR_OF_MEAN|2.151|||TWO_SIDED|90.0|2.72|9.89|||||Confidence interval (CI), estimated value and dispersion value of is presented for pre dose|||9.89|2.72|
71935358|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.43|STANDARD_ERROR_OF_MEAN|2.059|||TWO_SIDED|90.0|3.0|9.87|||||CI, estimated value and dispersion value of is presented for 1 hour post dose|||9.87|3.00|
71935359|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.71|STANDARD_ERROR_OF_MEAN|1.734|||TWO_SIDED|90.0|4.82|10.6|||||CI, estimated value and dispersion value of is presented for 2 hour post dose|||10.60|4.82|
71935360|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.42|STANDARD_ERROR_OF_MEAN|2.085|||TWO_SIDED|90.0|2.94|9.89|||||CI, estimated value and dispersion value of is presented for 3 hour post dose|||9.89|2.94|
71935361|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|2.434|||TWO_SIDED|90.0|2.54|10.65|||||CI, estimated value and dispersion value of is presented for 4 hour post dose|||10.65|2.54|
71935362|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.86|STANDARD_ERROR_OF_MEAN|2.573|||TWO_SIDED|90.0|1.57|10.14|||||CI, estimated value and dispersion value of is presented for 6 hour post dose|||10.14|1.57|
71935363|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.91|STANDARD_ERROR_OF_MEAN|2.735|||TWO_SIDED|90.0|0.35|9.47|||||CI, estimated value and dispersion value of is presented for 8 hour post dose|||9.47|0.35|
71691612|NCT03365934|142898438|SUPERIORITY||Mean Difference (Net)|-0.27|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3655|-0.1679|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6||-0.1679|-0.3655|<0.001
71935364|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.75|STANDARD_ERROR_OF_MEAN|2.8|||TWO_SIDED|90.0|4.08|13.42|||||CI, estimated value and dispersion value of is presented for 10 hour post dose|||13.42|4.08|
71935365|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.76|STANDARD_ERROR_OF_MEAN|2.759|||TWO_SIDED|90.0|1.16|10.36|||||CI, estimated value and dispersion value of is presented for 12 hour post dose|||10.36|1.16|
71935366|NCT01328054|143391833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|2.164|||TWO_SIDED|90.0|0.15|7.36|||||CI, estimated value and dispersion value of is presented for 24 hour post dose|||7.36|0.15|
71935367|NCT00291330|143391865|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.05|||<|0.0001||95.0|0.65|1.7||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.70|0.65|<0.0001
71935368|NCT00291330|143391865|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates|Risk Difference (Percentage)|0.4|||<|0.0001||95.0|-0.8|1.5||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.50|-0.80|<0.0001
71935369|NCT00291330|143391865|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||||95.0|0.65|1.84|||Regression, Cox|Patients without events are censored at day 180||Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.84|0.65|
71935370|NCT00291330|143391866|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.622||95.0|-1.0|1.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.70|-1.00|0.6220
71935371|NCT00291330|143391866|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.9844||95.0|0.69|1.46|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.46|0.69|0.9844
71935372|NCT00291330|143391867|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.2||||0.6466||95.0|-1.1|0.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.70|-1.10|0.6466
71935373|NCT00291330|143391867|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.76||||0.385||95.0|0.4|1.42|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.42|0.40|0.3850
71935374|NCT00291330|143391868|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|0.3||||0.2981||95.0|-0.3|1.0|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||1.00|-0.30|0.2981
71935375|NCT00291330|143391868|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.0||||0.1092||95.0|0.86|4.68|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||4.68|0.86|0.1092
71935376|NCT00291330|143391869|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.3||||0.5327||95.0|-1.2|0.6|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.60|-1.20|0.5327
71935377|NCT00291330|143391869|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.33||||0.3332||95.0|0.03|3.15|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||3.15|0.03|0.3332
71935378|NCT00291330|143391870|SUPERIORITY_OR_OTHER||Risk Difference (Percentage)|-0.1||||0.8018||95.0|-1.0|0.8|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.||0.80|-1.00|0.8018
71935379|NCT00291330|143391870|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8203||95.0|0.54|1.63|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.63|0.54|0.8203
71935380|NCT00291330|143391871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.5063||95.0|0.45|1.48|||Regression, Cox|||Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||1.48|0.45|0.5063
71935381|NCT00291330|143391871|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71||||0.0002|TWO_SIDED|95.0|0.59|0.85|||Regression, Cox|||Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.||0.85|0.59|0.0002
71935382|NCT00566709|143391875|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||t-test, 2 sided|||||||0.03
71935383|NCT00566709|143391876|SUPERIORITY_OR_OTHER|||||||0.07|TWO_SIDED||||||Chi-squared, Corrected|||||||0.07
71935384|NCT00566709|143391877|SUPERIORITY_OR_OTHER|||||||0.56|TWO_SIDED||||||Chi-squared, Corrected|||||||0.56
71935385|NCT00566709|143391878|SUPERIORITY_OR_OTHER|||||||0.79|TWO_SIDED||||||t-test, 2 sided|||||||0.79
71935386|NCT00566709|143391879|SUPERIORITY_OR_OTHER|||||||0.77|TWO_SIDED||||||Chi-squared, Corrected|||||||0.77
71935387|NCT00566709|143391880|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||Chi-squared, Corrected|||||||0.22
71935388|NCT03443869|143391884|NON_INFERIORITY|LET was concluded non-inferior to VGCV if the upper bound of the two-sided 95% CI for difference in percentage of participants with adjudicated CMV disease (LET - VGCV) was no higher than 10%|Stratum-adjusted Treatment Difference|-1.4|||||TWO_SIDED|95.0|-6.5|3.8|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||3.8|-6.5|
71935389|NCT03443869|143391885|OTHER||Stratum-adjusted Treatment Difference|-1.7|||||TWO_SIDED|95.0|-3.4|0.1|||||Difference = LET minus VGCV|The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures||0.1|-3.4|
71935390|NCT03443869|143391887|OTHER||Difference in Percentages|-0.1|||||TWO_SIDED|95.0|-4.4|4.2|||||Difference = LET minus VGCV|||4.2|-4.4|
71935391|NCT03443869|143391888|OTHER||Difference in Percentages|-3.7|||||TWO_SIDED|95.0|-7.0|-0.9|||||Difference = LET minus VGCV|||-0.9|-7.0|
71935392|NCT02826603|143391894|SUPERIORITY||Odds Ratio (OR)|2.21|||<|0.0001|TWO_SIDED|95.0|1.72|2.84|||Regression, Logistic|||||2.84|1.72|<0.0001
71935393|NCT02826603|143391895|SUPERIORITY||Odds Ratio (OR)|2.1|||<|0.0001|TWO_SIDED|95.0|1.63|2.72|||Regression, Logistic|||||2.72|1.63|<0.0001
71935394|NCT02826603|143391896|SUPERIORITY||Odds Ratio (OR)|2.62|||<|0.0001|TWO_SIDED|95.0|1.89|3.62|||Regression, Logistic|||||3.62|1.89|<0.0001
71691613|NCT03365934|142898438|SUPERIORITY||Mean Difference (Net)|-0.24|STANDARD_ERROR_OF_MEAN|0.05|<|0.001|TWO_SIDED|95.0|-0.3338|-0.1377|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6||-0.1377|-0.3338|<0.001
71935395|NCT02826603|143391897|SUPERIORITY||Odds Ratio (OR)|3.53|||<|0.0001|TWO_SIDED|95.0|2.65|4.71|||Regression, Logistic|||||4.71|2.65|<0.0001
71691614|NCT03365934|142898438|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.05||0.646|TWO_SIDED|95.0|-0.0767|0.1231|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6||0.1231|-0.0767|0.646
71935396|NCT02826603|143391898|SUPERIORITY||Odds Ratio (OR)|2.33|||<|0.0001|TWO_SIDED|95.0|1.8|3.01|||Regression, Logistic|||||3.01|1.80|<0.0001
71935397|NCT02826603|143391899|SUPERIORITY||Odds Ratio (OR)|2.57|||<|0.0001|TWO_SIDED|95.0|1.96|3.37|||Regression, Logistic|||||3.37|1.96|<0.0001
71935398|NCT02826603|143391900|SUPERIORITY||Odds Ratio (OR)|2.5|||<|0.0001|TWO_SIDED|95.0|1.89|3.31|||Regression, Logistic|||||3.31|1.89|<0.0001
71935399|NCT02826603|143391901|SUPERIORITY||Odds Ratio (OR)|2.86|||<|0.0001|TWO_SIDED|95.0|1.96|4.17|||Regression, Logistic|||||4.17|1.96|<0.0001
71935400|NCT02826603|143391902|SUPERIORITY||Odds Ratio (OR)|2.85|||<|0.0001|TWO_SIDED|95.0|2.19|3.71|||Regression, Logistic|||||3.71|2.19|<0.0001
71935401|NCT02826603|143391903|SUPERIORITY||Odds Ratio (OR)|1.84|||<|0.0001|TWO_SIDED|95.0|1.41|2.41|||Regression, Logistic|||||2.41|1.41|<0.0001
71935402|NCT00409188|143391904|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.893||||0.1566|TWO_SIDED|95.0|0.763|1.044|||Regression, Cox|||||1.044|0.763|0.1566
71935403|NCT00409188|143391905|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.845||||0.0226|TWO_SIDED|95.0|0.732|0.977|||Regression, Cox|||||0.977|0.732|0.0226
71935404|NCT00409188|143391906|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.0528|TWO_SIDED|95.0|0.752|1.002|||Regression, Cox|||||1.002|0.752|0.0528
71935405|NCT00433381|143391941|OTHER|||||||||||||||||Null hypothesis: 20% of patients progression-free at six months. Alternative hypothesis: 35%. Type I and II error rates = 0.10. Required sample size = 57.|The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
71935406|NCT00433381|143391942|OTHER|||||||||||||||||Null hypothesis: 35% discontinuation rate of bevacizumab and temozolomide. Alternative hypothesis: 5%. Type I and II error rates = 0.10. Sample size = 29.|The determination of treatment tolerability was to be made based on the following rules: If 6 or fewer of the cases (6/29=20.6%) stop treatment due to medical conditions, then reject the null hypothesis that the discontinuation rate is at least 35% and conclude tolerability. If 7 or more of the cases (7/29=24.1%) stop treatment due to medical conditions, then reject the alternative hypothesis that the discontinuation rate no more than 15%.|||
71935407|NCT00433381|143391943|OTHER|Receiver Operating Characteristic (ROC) analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.09|0.91||||||Accuracy estimate, as measured by the Area under the Curve (AUC), for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.91|0.09|
71935408|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.14|0.95||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.95|0.14|
71935409|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|0.99||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 2 weeks||0.99|0|
71935410|NCT00433381|143391943|OTHER||Area Under the Curve (AUC)|0.85|||||TWO_SIDED|95.0|0.53|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.53|
71935411|NCT00433381|143391943|OTHER||Area Under the Curve (AUC)|0.83|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.47|
71935412|NCT00433381|143391943|OTHER||Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.11|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.11|
71935413|NCT00433381|143391943|OTHER||Area Under the Curve (AUC)|0.75|||||TWO_SIDED|95.0|0.21|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.21|
71935414|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|1|
71935415|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.46|||||TWO_SIDED|95.0|0.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0|
71935416|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.39|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 2 weeks||0.88|0|
71935417|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.52|||||TWO_SIDED|95.0|0.13|0.91||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 2 weeks||0.91|0.13|
71935418|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.54|||||TWO_SIDED|95.0|0.06|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 2 weeks||1|0.06|
71935419|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.47|||||TWO_SIDED|95.0|0.02|0.92||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.92|0.02|
71935420|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.41|||||TWO_SIDED|95.0|0.01|0.8||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.80|0.01|
71935421|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.63|||||TWO_SIDED|95.0|0.22|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.22|
71935422|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
71935423|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|1|
71935424|NCT00433381|143391943|OTHER|ROC analysis|Area Under the Curve (AUC)|0.93|||||TWO_SIDED|95.0|0.73|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|0.73|
71935425|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.92||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 2 weeks||0.92|0|
71935426|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.42|||||TWO_SIDED|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 2 weeks||0.88|0|
71935427|NCT00433381|143391944|OTHER|ROC analysis|Accuracy: Area Under the ROC|0.67|||||TWO_SIDED|95.0|0.25|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 2 weeks||1|0.25|
71935428|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 8 weeks||1|0.47|
71935429|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.44|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 8 weeks||1|0.44|
71935430|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.17|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 8 weeks||1|0.17|
71935431|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.8|||||TWO_SIDED|95.0|0.45|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 16 weeks||1|0.45|
71935432|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.73|||||TWO_SIDED|95.0|0.19|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 16 weeks||1|0.19|
71935433|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.57|||||TWO_SIDED|95.0|0.03|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 16 weeks||1|0.03|
71935434|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.6|||||TWO_SIDED|95.0|0.2|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 2 weeks||1|0.20|
71935435|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.36|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 2 weeks||1|0.36|
71935436|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.06|0.94||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 2 weeks||0.94|0.06|
71935437|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.58|||||TWO_SIDED|95.0|0.22|0.95||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 8 weeks||0.95|0.22|
71935438|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.5|||||TWO_SIDED|95.0|0.13|0.87||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 8 weeks||0.87|0.13|
71935439|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.78|||||TWO_SIDED|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 8 weeks||1|0.47|
71935440|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 16 weeks||1|1|
71935441|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|0.89|||||TWO_SIDED|95.0|0.63|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 16 weeks||1|0.63|
71935442|NCT00433381|143391944|OTHER|ROC analysis|Area Under the Curve (AUC)|1.0|||||TWO_SIDED|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 16 weeks||1|1|
71935443|NCT00433381|143391945|OTHER||||||||||||||||||The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.|||
71935444|NCT00433381|143391947|OTHER|Agreement was assessed using a Kappa statistic|Kappa Statistic|0.39|||||TWO_SIDED|95.0|0.21|0.57||||||Agreement between Local and Central determinations 6-month PFS, based on imaging, was evaluated using Kappa statistics||0.57|0.21|
71935445|NCT00433381|143391948|OTHER|Sensitivity|Sensitivity|0.6|||||TWO_SIDED|95.0|0.46|0.73||||||Sensitivity||0.73|0.46|
71935446|NCT00433381|143391948|OTHER|Specificity|Specificity|0.78|||||TWO_SIDED|95.0|0.66|0.87||||||Specificity||0.87|0.66|
71935447|NCT00549198|143391967|SUPERIORITY_OR_OTHER|||||||0.435||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.435
71935448|NCT00549198|143391968|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.057
71935449|NCT00549198|143391969|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment\*visit, baseline GFR by MDRD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.060
71935450|NCT00549198|143391970|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.186
71935451|NCT00549198|143391971|SUPERIORITY_OR_OTHER|||||||0.413||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline GFR by CG\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.413
71935452|NCT00549198|143391972|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment\*visit, baseline GFR by CG\*visit, baseline BMI\*visit and baseline CD4\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.315
71935453|NCT00549198|143391979|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
71935454|NCT00549198|143391980|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
71935455|NCT00549198|143391981|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||0.036
71935456|NCT00549198|143391982|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|Correlation matrix for within-subject errors is unstructured.||||||<0.001
71935457|NCT00549198|143391983|SUPERIORITY_OR_OTHER|||||||0.112||95.0||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment\*visit, baseline spine BMD\*visit and baseline BMI\*visit.|Mixed Models Analysis|correlation matrix for within-subject errors is unstructured.||||||0.112
71935458|NCT00549198|143391984|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment\*visit, baseline hip BMD\*visit, and baseline BMI\*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.||||||<0.001
71935459|NCT00549198|143392017|SUPERIORITY_OR_OTHER|||||||0.3025||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3025
71935460|NCT00549198|143392018|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
71935461|NCT00549198|143392019|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||0.3323
71935462|NCT00549198|143392020|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
71935463|NCT00549198|143392021|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.||||||<0.0001
71935464|NCT00549198|143392022|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
71935465|NCT00549198|143392023|SUPERIORITY_OR_OTHER|||||||0.0019||95.0||||The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0019
71935466|NCT00549198|143392024|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.||||||0.0266
71935467|NCT00472446|143392025|SUPERIORITY_OR_OTHER|||||||0.028|||||||t-test, 2 sided|||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||.028
71935468|NCT00472446|143392026|SUPERIORITY_OR_OTHER|||||||0.016|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)||||0.016
71935469|NCT00472446|143392026|SUPERIORITY_OR_OTHER|||||||0.723|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure pre-operative versus post-operative application||||0.723
71935470|NCT00472446|143392028|SUPERIORITY_OR_OTHER|||||||0.94|TWO_SIDED||||||Fisher Exact|mid p value of the two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:"||||0.94
71935471|NCT00472446|143392028|SUPERIORITY_OR_OTHER|||||||0.58|TWO_SIDED||||||Fisher Exact|mid p value of two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:"||||0.58
71935472|NCT00472446|143392029|SUPERIORITY_OR_OTHER|||||||0.328|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamol"||||0.328
71935473|NCT00472446|143392029|SUPERIORITY_OR_OTHER|||||||0.81|TWO_SIDED||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizole"||||0.81
71935474|NCT00472446|143392029|SUPERIORITY_OR_OTHER|||||||0.331|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dose"||||0.331
71935475|NCT00472446|143392029|SUPERIORITY_OR_OTHER|||||||0.44|TWO_SIDED||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dose"||||0.440
71935476|NCT00472446|143392030|SUPERIORITY_OR_OTHER|||||||0.925|TWO_SIDED||||||non-parametric ANOVA-type statistic|non-parametric ANOVA-type statistic for pooled main effects, full model||null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment||||0.925
71935477|NCT01165684|143392031|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently if the p-value for the one-sided test of was less than or equal to 2.5%, where D is the mean treatment difference (step-wise regimen minus basal-bolus regimen).|Estimated treatment difference, Mean|0.14||||0.088||95.0|-0.02|0.3|||Regression, Linear|||||0.30|-0.02|0.088
71935478|NCT01165684|143392032|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.55|||<|0.001||95.0|0.42|0.69|||Regression, Linear|||||0.69|0.42|<0.001
71935479|NCT01165684|143392033|SUPERIORITY_OR_OTHER||Estimated treatment difference, Mean|0.37|||<|0.001||95.0|0.21|0.53|||Regression, Linear|||||0.53|0.21|<0.001
71935480|NCT01165684|143392034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.85|||<|0.001||95.0|4.12|11.39|||Regression, Logistic|||||11.39|4.12|<0.001
71935481|NCT01165684|143392035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38|||<|0.001||95.0|1.56|3.64|||Regression, Logistic|||||3.64|1.56|<0.001
71935482|NCT01165684|143392036|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36||||0.146||95.0|0.9|2.07|||Regression, Logistic|||||2.07|0.90|0.146
71935483|NCT01165684|143392039|SUPERIORITY_OR_OTHER||Estimated Mean|0.12||||0.635||95.0|-0.37|0.6|||Regression, Linear|||||0.60|-0.37|0.635
71935484|NCT01165684|143392042|SUPERIORITY_OR_OTHER||Estimated mean|0.36||||0.046||95.0|0.01|0.71|||Regression, Linear|||||0.71|0.01|0.046
71935485|NCT01165684|143392043|SUPERIORITY_OR_OTHER||Estimated mean|-0.48||||0.228||95.0|-1.25|0.3|||Regression, Linear|||||0.30|-1.25|0.228
71935486|NCT01165684|143392044|SUPERIORITY_OR_OTHER||Estimated mean|-0.17||||0.224||95.0|-0.45|0.11|||Regression, Linear|||||0.11|-0.45|0.224
71935487|NCT01797120|143392105|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.02|TWO_SIDED|95.0|0.4|0.92|||Log Rank|Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease||||0.92|0.40|0.02
71935488|NCT01797120|143392106|SUPERIORITY|||||||0.01|||||||Fisher Exact|||||||0.01
71935489|NCT01797120|143392107|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71935490|NCT02462421|143392109|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||No adjustment for multiple comparisons. Viewed as unnecessary inasmuch as none of the comparisons achieved p\<0.05.|t-test, 2 sided|||"Each of the variant genotypes was compared to the control group (homozygous for major alleles at all three genetic loci) in an unpaired t-test. The study was terminated early because it was clear that we would not meet our recruitment targets and that the study was likely underpowered.~Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant."||||0.92
71935491|NCT02462421|143392109|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.63||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.63
71935492|NCT02462421|143392109|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.86||||||Not adjusted for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.86
71935493|NCT02462421|143392110|OTHER|"We compared the two groups (wild type versus SLC2A9 variant homozygotes. Null hypothesis: there are no differences between the two groups with respect to the pharmacodynamic effect of canagliflozin on fractional excretion of uric acid in the urine."||||||0.04||||||Because the study was terminated early, we did not have sufficient statistical power to adjust for multiple comparisons. We are reporting a nominal p-value without adjusting for multiple comparisons|t-test, 2 sided|||The study was terminated early because of slow recruitment. As a result the study did not achieve the statistical power that had been planned.||||0.04
71935494|NCT02462421|143392111|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.07||||||Not corrected for multiple comparisons|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.07
71935495|NCT02462421|143392111|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.53||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.53
71935496|NCT02462421|143392111|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
71691615|NCT03365934|142898439|SUPERIORITY||Mean Difference (Net)|-0.13|STANDARD_ERROR_OF_MEAN|0.047||0.006|TWO_SIDED|95.0|-0.2254|-0.0384|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7||-0.0384|-0.2254|0.006
71935497|NCT02462421|143392112|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.|||||<|0.01||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||<0.01
71935498|NCT02462421|143392112|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.77||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.77
71935499|NCT02462421|143392112|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.65||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.65
71935500|NCT02462421|143392113|OTHER|Null hypothesis: None of the three genotypes is associated with an alteration in the pharmacodynamic effect of canagliflozin on urinary Na excretion||||||0.2||||||Because the study was terminated early, the study does not have sufficient statistical power to adjust for multiple comparisons. Accordingly, nominal p-values are reported.|t-test, 2 sided|||"The wild type genotype group was compared to homozygotes for each of the three other genotypes."||||0.20
71935501|NCT02462421|143392113|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.01|||||||t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.01
71935502|NCT02462421|143392113|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.16||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.16
71935503|NCT02462421|143392114|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.21||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.21
71935504|NCT02462421|143392114|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.92||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Null hypothesis: pharmacodynamic response is the same in the control group and homozygotes for the genetic variant.||||0.92
71935505|NCT02462421|143392114|OTHER|Probability that the observed difference was the result of random variation rather than a difference between the two populations.||||||0.39||||||Not corrected for multiple comparisons.|t-test, 2 sided|||Not corrected for multiple comparisons.||||0.39
71691616|NCT03365934|142898439|SUPERIORITY||Mean Difference (Net)|-0.15|STANDARD_ERROR_OF_MEAN|0.047||0.002|TWO_SIDED|95.0|-0.2444|-0.0574|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7||-0.0574|-0.2444|0.002
71691617|NCT03365934|142898439|SUPERIORITY||Mean Difference (Net)|-0.16|STANDARD_ERROR_OF_MEAN|0.047||0.001|TWO_SIDED|95.0|-0.2541|-0.0682|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7||-0.0682|-0.2541|0.001
71691618|NCT03365934|142898439|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.048||0.911|TWO_SIDED|95.0|-0.0891|0.0998|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7||0.0998|-0.0891|0.911
71935506|NCT01339910|143392138|SUPERIORITY||Difference in 18 month OS (MAC-RIC)|9.8||||0.07|TWO_SIDED|95.0|-0.8|20.3||This final test was performed at a 0.049 significance level, since 0.001 was spent at interim analyses and the overall significance level was 0.050.|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in overall survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month overall survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||20.3|-0.8|0.07
71935507|NCT01339910|143392139|SUPERIORITY||Difference in 18 month RFS (MAC-RIC)|20.4|||<|0.01|TWO_SIDED|95.0|8.9|32.0||Test performed at a significance level of 0.05|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in relapse-free survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month relapse-free survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.||32.0|8.9|< 0.01
71935508|NCT01339910|143392140|SUPERIORITY||||||<|0.001||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of disease relapse during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of disease relapse was compared between treatment arms using Gray's test, treating death as a competing risk.||||< 0.001
71935509|NCT01339910|143392141|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of treatment-related mortality was compared between treatment arms using Gray's test, treating disease relapse as a competing risk.||||0.002
71691619|NCT03365934|142898440|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.04||0.937|TWO_SIDED|95.0|-0.0818|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14||0.0755|-0.0818|0.937
71691620|NCT03365934|142898440|SUPERIORITY||Mean Difference (Net)|-0.09|STANDARD_ERROR_OF_MEAN|0.039||0.026|TWO_SIDED|95.0|-0.1663|-0.0108|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14||-0.0108|-0.1663|0.026
71691621|NCT03365934|142898440|SUPERIORITY||Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|0.039||0.045|TWO_SIDED|95.0|-0.1562|-0.0017|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14||-0.0017|-0.1562|0.045
71691622|NCT03365934|142898440|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.039||0.956|TWO_SIDED|95.0|-0.0799|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14||0.0755|-0.0799|0.956
71691623|NCT04194489|142898441|OTHER|Effect size calculation|Cohen's d|0.43|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71691624|NCT04194489|142898442|OTHER|Effect size|Cohen's d|0.17|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71691625|NCT04194489|142898443|OTHER|Effect size calculation|Cohen's d|0.27|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71691626|NCT04194489|142898444|OTHER|Effect size calculation|Cohen's d|0.02|||||TWO_SIDED|||||||||Cohen's d effect size was calculated using baseline and follow-up means and standard deviations. An effect size of 0.2 is small, 0.5 is medium and 0.8 is large.||||
71691627|NCT00522548|142898461|SUPERIORITY|||||||0.29||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.29
71691628|NCT00522548|142898462|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED|95.0||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.39
71691629|NCT00522548|142898463|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.0
71691630|NCT00522548|142898464|SUPERIORITY|||||||1||||||A p value of less than 0.05 was considered significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||1.00
71691631|NCT00522548|142898465|SUPERIORITY|||||||0.14||||||a p value of less than 0.05 was considered statistically significant|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.14
71691632|NCT00522548|142898466|SUPERIORITY|||||||0.34||||||A p value of less than 0.05 was considered statistically significant.|Chi-squared|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.34
71691633|NCT00522548|142898467|SUPERIORITY_OR_OTHER|||||||0.51||||||A p-value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||.51
71691634|NCT00522548|142898468|SUPERIORITY|||||||0.95|TWO_SIDED|95.0||||A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.95
71691635|NCT00522548|142898469|SUPERIORITY|||||||0.57||||||The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.57
71691636|NCT00522548|142898470|SUPERIORITY|||||||0.45|TWO_SIDED|95.0||||This represents p value for week 4 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.45
71691637|NCT00522548|142898470|SUPERIORITY|||||||0.58|TWO_SIDED|95.0||||This represents p value for week 24 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.||||0.58
71691638|NCT00522548|142898471|SUPERIORITY|||||||0.012||||||This p value is for data at week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.012
71691639|NCT00522548|142898471|SUPERIORITY|||||||0.046|TWO_SIDED|95.0||||This p value was for data at week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.||||0.046
71691640|NCT00522548|142898472|SUPERIORITY|||||||0.27||||||p value represents data for week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.27
71691641|NCT00522548|142898472|SUPERIORITY|||||||0.23|TWO_SIDED|95.0||||p value represents data for week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study||||0.23
71691642|NCT02121795|142898473|NON_INFERIORITY|Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.|Percentage difference|1.3||||0.5|TWO_SIDED|95.002|-2.5|5.1|||Cochran-Mantel-Haenszel|P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.|Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.|||5.1|-2.5|0.5
71691643|NCT02363387|142898499|SUPERIORITY||Odds Ratio (OR)|7.1|||<|0.001|TWO_SIDED|95.0|2.7|18.8|||Regression, Logistic|||||18.8|2.7|<0.001
71691644|NCT02609386|142898506|OTHER||Cox Proportional Hazard|1.102||||0.6176|TWO_SIDED|95.0|0.6|2.1|||Log Rank|||||2.1|0.6|0.6176
71691645|NCT02609386|142898507|OTHER||Cox Proportional Hazard|1.009||||0.3889|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.3889
71935510|NCT01339910|143392142|SUPERIORITY|||||||0.002||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of neutrophil engraftment at Day 28 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.002
71935511|NCT01339910|143392142|SUPERIORITY|||||||0.065||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment at Day 60 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of platelet engraftment at Day 60 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.||||0.065
71935512|NCT01339910|143392143|SUPERIORITY|||||||0.005||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.005
71935513|NCT01339910|143392143|SUPERIORITY|||||||0.011||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 100 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.011
71935514|NCT01339910|143392143|SUPERIORITY|||||||0.39||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at 18 months post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.||||0.39
71935515|NCT01339910|143392144|SUPERIORITY|||||||0.024||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade II-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade II-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.024
71935516|NCT01339910|143392144|SUPERIORITY|||||||0.066||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade III-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade III-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.066
71935517|NCT01339910|143392145|SUPERIORITY|||||||0.019||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of chronic GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.||||0.019
71935518|NCT02555618|143392201|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.7|||||TWO_SIDED|95.0|-7.983|11.415|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||11.415|-7.983|
71935519|NCT02555618|143392201|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-4.8|||||TWO_SIDED|95.0|-13.974|4.403|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||4.403|-13.974|
71935520|NCT02555618|143392201|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|2.6|||||TWO_SIDED|95.0|-6.082|11.32|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||11.320|-6.082|
71935521|NCT02555618|143392202|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.99|||||TWO_SIDED|95.0|0.7984|1.2253|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2253|0.7984|
71935522|NCT02555618|143392202|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.76|||||TWO_SIDED|95.0|0.5544|1.05|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0500|0.5544|
71935523|NCT02555618|143392202|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.06|||||TWO_SIDED|95.0|0.8134|1.3931|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3931|0.8134|
71935524|NCT02555618|143392205|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|6.8|||||TWO_SIDED|95.0|-3.02|16.348||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||16.348|-3.020|
71935525|NCT02555618|143392205|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-8.8|||||TWO_SIDED|95.0|-18.282|0.901||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||0.901|-18.282|
71935526|NCT02555618|143392205|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.3|||||TWO_SIDED|95.0|-11.461|6.835||||||The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||6.835|-11.461|
71935527|NCT02555618|143392206|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9559|1.1473|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.1473|0.9559|
71691646|NCT02609386|142898508|OTHER||Cox Proportional Hazard|1.009||||0.5091|TWO_SIDED|95.0|0.5|2.2|||Log Rank|||||2.2|0.5|0.5091
71935528|NCT02555618|143392206|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.9|||||TWO_SIDED|95.0|0.7862|1.0241|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.0241|0.7862|
71691647|NCT04391179|142898524|SUPERIORITY||Slope|-0.033|STANDARD_ERROR_OF_MEAN|0.027||0.24|TWO_SIDED|95.0|-0.089|0.023|||Mixed Models Analysis||Estimation represents log-scale difference between average daily change in D-Dimer for Dipyridamole patients minus placebo average daily change. Negative estimates indicate that D-Dimer levels decline faster in Dipyridamole versus placebo patients.|||.023|-.089|0.24
71935529|NCT02555618|143392206|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.9273|1.0364|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.0364|0.9273|
71935530|NCT02555618|143392209|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|14.7|||||TWO_SIDED|95.0|5.489|23.577||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||23.577|5.489|
71935531|NCT02555618|143392209|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-1.9|||||TWO_SIDED|95.0|-10.614|6.928||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||6.928|-10.614|
71935532|NCT02555618|143392209|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-2.4|||||TWO_SIDED|95.0|-10.346|5.579||||||The analysis is difference of seroconversion rate between treatment groups for B-Strain.||5.579|-10.346|
71935533|NCT02555618|143392210|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.48|||||TWO_SIDED|95.0|1.1221|1.9623|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.9623|1.1221|
71935534|NCT02555618|143392210|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.7806|1.4564|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.||1.4564|0.7806|
71935535|NCT02555618|143392210|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.8166|1.3934|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.3934|0.8166|
71935536|NCT02555618|143392213|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|1.1|||||TWO_SIDED|95.0|-7.195|9.423|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.||9.423|-7.195|
71935537|NCT02555618|143392213|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|-0.8|||||TWO_SIDED|95.0|-10.369|8.803|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.||8.803|-10.369|
71935538|NCT02555618|143392213|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to -20%.|Rate difference|3.2|||||TWO_SIDED|95.0|-6.406|12.757|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.||12.757|-6.406|
71935539|NCT02555618|143392214|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||TWO_SIDED|95.0|0.9106|1.2484|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.||1.2484|0.9106|
71935540|NCT02555618|143392214|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||TWO_SIDED|95.0|0.8686|1.0969|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.||1.0969|0.8686|
71935541|NCT02555618|143392214|NON_INFERIORITY_OR_EQUIVALENCE|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||TWO_SIDED|95.0|0.9622|1.1427|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.||1.1427|0.9622|
71935542|NCT02063698|143392220|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2: BPI Worst Pain Past 24 Hours||||1.0
71935543|NCT02063698|143392220|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Day 3: BPI Worst Pain Past 24 Hours||||0.45
71935544|NCT02063698|143392220|SUPERIORITY|||||||0.38|||||||Fisher Exact|||Day 4: BPI Worst Pain Past 24 Hours||||0.38
71935545|NCT02063698|143392220|SUPERIORITY|||||||0.12|||||||Fisher Exact|||Day 5: BPI Worst Pain Past 24 Hours||||0.12
71935546|NCT02063698|143392220|SUPERIORITY|||||||0.7|||||||Fisher Exact|||Day 6: BPI Worst Pain Past 24 Hours||||0.70
71935547|NCT02063698|143392220|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 7: BPI Worst Pain Past 24 Hours||||1.0
71935548|NCT02063698|143392220|SUPERIORITY|||||||0.44|||||||Fisher Exact|||Day 8: BPI Worst Pain Past 24 Hours||||0.44
71935549|NCT02063698|143392221|SUPERIORITY|||||||0.44|||||||Equal variance t-test|||||||0.44
71935550|NCT02063698|143392222|SUPERIORITY|||||||0.13|||||||Equal variance t-test|||||||0.13
71935551|NCT02063698|143392224|SUPERIORITY|||||||0.025|||||||Chi-squared|||||||0.025
71935552|NCT02063698|143392225|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71935553|NCT02063698|143392226|SUPERIORITY|||||||0.02|||||||Chi-squared|||||||0.02
71935554|NCT02063698|143392227|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71935555|NCT02063698|143392228|SUPERIORITY|||||||0.04|||||||Chi-squared|||||||0.04
71935556|NCT01271933|143392260|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0186|TWO_SIDED|||||The p-value was calculated using log-rank test for comparing pregabalin CR with placebo|Log Rank|||||||0.0186
71935557|NCT01271933|143392264|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.41||0.331|TWO_SIDED|95.0|-1.2|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||||0.4|-1.2|0.3310
71935558|NCT01271933|143392267|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.4||0.9247|TWO_SIDED|95.0|-0.8|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.8|-0.8|0.9247
71935559|NCT01271933|143392276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|7.12||0.4314|TWO_SIDED|95.0|-19.7|8.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: Subjective Wake after Sleep Onset||8.5|-19.7|0.4314
71935560|NCT01271933|143392276|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|9.26||0.8915|TWO_SIDED|95.0|-17.1|19.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Subjective Latency to Sleep Onset||19.6|-17.1|0.8915
71935561|NCT01271933|143392277|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.41||0.4571|TWO_SIDED|95.0|-0.5|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.5|0.4571
71935562|NCT01271933|143392278|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3779|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3779
71935563|NCT01271933|143392279|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.34||0.2009|TWO_SIDED|95.0|-0.2|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||1.1|-0.2|0.2009
71935564|NCT01271933|143392281|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.48||0.1845|TWO_SIDED|95.0|-1.6|0.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.3|-1.6|0.1845
71691648|NCT04391179|142898525|SUPERIORITY||win ratio|1.0||||0.98|TWO_SIDED|97.8|0.78|1.29|||Mantel Haenszel||win ratio= (the probability of a win for the dipyridamole patient)/(probability of a win for the placebo patient)|A win ratio analysis of the hierarchical composite outcome requiring direct comparison of outcomes between each dipyridamole patient and placebo patient. The patient with the superior outcome is adjudicated the 'winner' and receives a +1 score, while the 'loser' scores -1.||1.29|0.78|.98
71691649|NCT04391179|142898526|SUPERIORITY|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||.08
71691650|NCT04391179|142898527|SUPERIORITY|||||||0.09|||||||Log Rank|||||||.09
71691651|NCT04391179|142898528|SUPERIORITY||Mean Difference (Net)|0.29||||0.36|TWO_SIDED|95.0|0.02|3.94|||regression, negative binomial||estimated ratio of days on mechanical ventilation for dipyridamole and placebo|||3.94|0.02|0.36
71691652|NCT04391179|142898529|SUPERIORITY||Odds Ratio (OR)|1.04||||0.94|TWO_SIDED|95.0|0.43|2.51|||Regression, Logistic||Odds of a 50 point drop in the dipyridamole group relative to the placebo group.|||2.51|0.43|.94
71691653|NCT04391179|142898530|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||||||.95
71691654|NCT03442088|142898562|OTHER||Mean Difference (Final Values)|-0.272||||0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0001
71691655|NCT03442088|142898563|OTHER||Mean Difference (Final Values)|95.98||||0.934|TWO_SIDED|95.0|-2324.0|2516.0|||t-test, 2 sided|||||2516|-2324|0.934
71691656|NCT03442088|142898564|OTHER||Mean Difference (Final Values)|-0.6878||||0.1632|TWO_SIDED|95.0|-1.685|0.3097|||t-test, 2 sided|||||0.3097|-1.685|0.1632
71691657|NCT03442088|142898565|OTHER||Mean Difference (Final Values)|-2.344||||0.1063|TWO_SIDED|95.0|-5.248|0.5992|||t-test, 2 sided|||||0.5992|-5.248|0.1063
71691658|NCT03442088|142898566|OTHER||Mean Difference (Final Values)|3.24||||0.5611|TWO_SIDED|95.0|-8.333|14.81|||t-test, 2 sided|||||14.81|-8.333|0.5611
71691659|NCT00105989|142898571|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05.|Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.||||<0.001
71691660|NCT00105989|142898572|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|Frequencies are analyzed using Cochran-Mantel-Haenszel controlling for investigator||||||<0.001
71691661|NCT00105989|142898573|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||||||0.003
71691662|NCT00105989|142898574|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Cochran-Mantel-Haenszel|Frequencies were analyzed using Cochran-Mantel-Haenszel controlling for investigator.||||||0.003
71691663|NCT00105989|142898575|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691664|NCT00105989|142898575|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.016
71691665|NCT00105989|142898576|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71691666|NCT00105989|142898577|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691667|NCT00105989|142898577|SUPERIORITY_OR_OTHER|||||||0.153||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.153
71691668|NCT00105989|142898578|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71691669|NCT00105989|142898579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
71691670|NCT00105989|142898579|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.||||||<0.001
71691671|NCT00105989|142898580|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71691672|NCT00105989|142898581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint for all Subscales during Acute phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691673|NCT00105989|142898581|SUPERIORITY_OR_OTHER|||||||0.334||95.0||||P-value for Anxiety Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.334
71691674|NCT00105989|142898581|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||P-value for Core Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.019
71691675|NCT00105989|142898581|SUPERIORITY_OR_OTHER|||||||0.046||95.0||||P-value for Maier Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.046
71691676|NCT00105989|142898581|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Retardation Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691677|NCT00105989|142898581|SUPERIORITY_OR_OTHER|||||||0.319||95.0||||P-value for Sleep Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.319
71691678|NCT00105989|142898581|SUPERIORITY_OR_OTHER|||||||0.275||95.0||||P-value for Depressed Mood Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.275
71935565|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|4.52||0.0305|TWO_SIDED|95.0|-18.9|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep disturbance||1.0|-18.9|0.0305
71935566|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.17||0.3133|TWO_SIDED|95.0|-5.0|15.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Snoring||15.5|-5.0|0.3133
71935567|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.9|STANDARD_ERROR_OF_MEAN|3.71||0.2985|TWO_SIDED|95.0|-11.2|3.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Awakening Short of Breath or with a Headache||3.5|-11.2|0.2985
71935568|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.8|STANDARD_ERROR_OF_MEAN|5.49||0.2159|TWO_SIDED|95.0|-4.1|17.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep adequacy||17.7|-4.1|0.2159
71935569|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2|STANDARD_ERROR_OF_MEAN|4.1||0.2041|TWO_SIDED|95.0|-13.4|2.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Somnolence||2.9|-13.4|0.2041
71935570|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.8|STANDARD_ERROR_OF_MEAN|3.81||0.1319|TWO_SIDED|95.0|-13.4|1.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index I||1.8|-13.4|0.1319
71935571|NCT01271933|143392284|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|3.89||0.1473|TWO_SIDED|95.0|-13.4|2.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index II||2.0|-13.4|0.1473
71935572|NCT01271933|143392285|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3596|TWO_SIDED|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-0.2|0.3596
71935573|NCT01271933|143392287|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.25||||0.4985|TWO_SIDED|95.0|0.66|2.36||Nominal p-value for two-sided test.|two-sided test|||"Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.~Odds ratio \> 1 is in favor of Pregabalin 330 - 495 mg/day."||2.36|0.66|0.4985
71935574|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|4.1||0.74|TWO_SIDED|95.0|-9.5|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Physical Functioning||6.8|-9.5|0.7400
71935575|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|4.89||0.5938|TWO_SIDED|95.0|-7.1|12.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Physical||12.3|-7.1|0.5938
71935576|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|4.61||0.4842|TWO_SIDED|95.0|-5.9|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Pain Index||12.4|-5.9|0.4842
71935577|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|3.45||0.0827|TWO_SIDED|95.0|-12.9|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: SF-36 General Health Perceptions||0.8|-12.9|0.0827
71935578|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|4.73||0.4561|TWO_SIDED|95.0|-12.09|5.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Vitality||5.8|-12.09|0.4561
71935579|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|4.31||0.9645|TWO_SIDED|95.0|-8.8|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Social Functioning||8.4|-8.8|0.9645
71935580|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|5.41||0.7636|TWO_SIDED|95.0|-9.1|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Emotional||12.4|-9.1|0.7636
71935581|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|3.54||0.7067|TWO_SIDED|95.0|-5.7|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Mental Health Index||8.4|-5.7|0.7067
71691679|NCT00105989|142898582|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Anxiety Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||<0.001
71691680|NCT00105989|142898582|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Core Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
71691681|NCT00105989|142898582|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Pairwise comparison of Least Squares Means for Maier Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.002
71691682|NCT00105989|142898582|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Retardation Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
71691683|NCT00105989|142898582|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value for Pairwise comparison of Least Squares Means for Sleep Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.001
71691684|NCT00105989|142898582|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value for Pairwise comparison of Least Squares Means for Depressed Mood Subscale Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.003
71691685|NCT00105989|142898583|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for all Change from Baseline to Endpoint measures in the Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691686|NCT00105989|142898583|SUPERIORITY_OR_OTHER|||||||0.273||95.0||||P-value for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.273
71935582|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|1.78||0.8352|TWO_SIDED|95.0|-3.9|3.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Component Score||3.2|-3.9|0.8352
71691687|NCT00105989|142898583|SUPERIORITY_OR_OTHER|||||||0.968||95.0||||P-value for Headache Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.968
71691688|NCT00105989|142898583|SUPERIORITY_OR_OTHER|||||||0.998||95.0||||P-value for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.998
71691689|NCT00105989|142898583|SUPERIORITY_OR_OTHER|||||||0.703||95.0||||P-value for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.703
71935583|NCT01271933|143392289|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|2.22||0.9347|TWO_SIDED|95.0|-4.2|4.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental Component Score||4.6|-4.2|0.9347
71691690|NCT00105989|142898583|SUPERIORITY_OR_OTHER|||||||0.346||95.0||||P-value for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.346
71691691|NCT00105989|142898583|SUPERIORITY_OR_OTHER|||||||0.963||95.0||||P-value for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.963
71691692|NCT00105989|142898584|SUPERIORITY_OR_OTHER|||||||0.792||95.0||||P-value for pairwise comparison of Least Squares Means for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.792
71691693|NCT00105989|142898584|SUPERIORITY_OR_OTHER|||||||0.407||95.0||||P-value for pairwise comparison of Least Squares Means for Headache Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.407
71691694|NCT00105989|142898584|SUPERIORITY_OR_OTHER|||||||0.475||95.0||||P-value for pairwise comparison of Least Squares Means for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.475
71691695|NCT00105989|142898584|SUPERIORITY_OR_OTHER|||||||0.241||95.0||||P-value for pairwise comparison of Least Squares Means for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.241
71691696|NCT00105989|142898584|SUPERIORITY_OR_OTHER|||||||0.885||95.0||||P-value for pairwise comparison of Least Squares Means for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.885
71691697|NCT00105989|142898584|SUPERIORITY_OR_OTHER|||||||0.717||95.0||||P-value for pairwise comparison of Least Squares Means for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|||||||0.717
71691698|NCT00105989|142898585|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691699|NCT00105989|142898585|SUPERIORITY_OR_OTHER|||||||0.157||95.0||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.157
71691700|NCT00105989|142898586|SUPERIORITY_OR_OTHER|||||||0.979||95.0|||||t-test, 2 sided|||||||0.979
71935584|NCT01271933|143392291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.69||0.1901|TWO_SIDED|95.0|-0.5|2.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-A Anxiety scale||2.3|-0.5|0.1901
71935585|NCT01271933|143392291|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.65||0.6914|TWO_SIDED|95.0|-1.6|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-D Depression scale||1.0|-1.6|0.6914
71691701|NCT00105989|142898587|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in Acute Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691702|NCT00105989|142898587|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to Endpoint in all SDS items in the Continuation Phase were \<0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691703|NCT00105989|142898588|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Global Score|t-test, 2 sided|||||||0.029
71691704|NCT00105989|142898588|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Work/School.|t-test, 2 sided|||||||0.022
71691705|NCT00105989|142898588|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Social Life.|t-test, 2 sided|||||||0.110
71691706|NCT00105989|142898588|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Family Life/Home Responsibilities.|t-test, 2 sided|||||||0.021
71691707|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-values for Change from Baseline to Endpoint in all SF-36 subscales in the Acute Phase were \<0.001|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71935586|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.41||0.3721|TWO_SIDED|95.0|-0.5|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 1: Physical activities||1.2|-0.5|0.3721
71691708|NCT00105989|142898589|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value for Physical Component Summary Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.947
71691709|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Component Summary Change to Endpoint|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691710|NCT00105989|142898589|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P-value for Physical Functioning Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.118
71691711|NCT00105989|142898589|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||P-value for Bodily Pain Change from Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.550
71691712|NCT00105989|142898589|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value for Role Limitations Due to Physical Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.029
71691713|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Role Limitations Due to Emotional Problems Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691714|NCT00105989|142898589|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for General Health Perceptions Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
71691715|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Mental Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691716|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Social Function Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691717|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Vitality Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691718|NCT00105989|142898589|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||P-value for Rate Current Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.815
71691719|NCT00105989|142898589|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Health Compared to a Year Ago Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691720|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.415||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Component Summary.|t-test, 2 sided|||||||0.415
71691721|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Component Summary.|t-test, 2 sided|||||||0.002
71691722|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.731||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Functioning.|t-test, 2 sided|||||||0.731
71691723|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.438||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Bodily Pain.|t-test, 2 sided|||||||0.438
71691724|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.029||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Physical.|t-test, 2 sided|||||||0.029
71691725|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Emotional problems.|t-test, 2 sided|||||||0.003
71691726|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-General Health Perceptions.|t-test, 2 sided|||||||0.391
71935587|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.64||0.8084|TWO_SIDED|95.0|-1.1|1.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 2: Feel good||1.4|-1.1|0.8084
71935588|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.35||0.6312|TWO_SIDED|95.0|-0.9|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 3: Work missed||0.5|-0.9|0.6312
71691727|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Health.|t-test, 2 sided|||||||0.001
71691728|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.142||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Social Functioning.|t-test, 2 sided|||||||0.142
71691729|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.24||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Vitality.|t-test, 2 sided|||||||0.240
71691730|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.615||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Rate General Health.|t-test, 2 sided|||||||0.615
71691731|NCT00105989|142898590|SUPERIORITY_OR_OTHER|||||||0.218||95.0||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Health Compared to a Year Ago.|t-test, 2 sided|||||||0.218
71935589|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.57||0.8824|TWO_SIDED|95.0|-1.0|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 4: Do job||1.2|-1.0|0.8824
71935590|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.49||0.2742|TWO_SIDED|95.0|-1.5|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 5: Pain||0.4|-1.5|0.2742
71935591|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.46||0.852|TWO_SIDED|95.0|-0.8|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 6: Fatigue||1.0|-0.8|0.8520
71935592|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.55||0.5264|TWO_SIDED|95.0|-1.4|0.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 7: Rested||0.7|-1.4|0.5264
71935593|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.55||0.6601|TWO_SIDED|95.0|-1.3|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 8: Stiffness||0.9|-1.3|0.6601
71935594|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.56||0.8937|TWO_SIDED|95.0|-1.2|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 9: Anxiety||1.0|-1.2|0.8937
71935595|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.47||0.9151|TWO_SIDED|95.0|-1.0|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 10: Depression||0.9|-1.0|0.9151
71935596|NCT01271933|143392293|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|3.91||0.9045|TWO_SIDED|95.0|-8.2|7.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the total score||7.3|-8.2|0.9045
71935597|NCT01271933|143392295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.31||0.4606|TWO_SIDED|95.0|-0.4|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: General Fatigue||0.9|-0.4|0.4606
71935598|NCT01271933|143392295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.37||0.4703|TWO_SIDED|95.0|-1.0|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Fatigue||0.5|-1.0|0.4703
71935599|NCT01271933|143392295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.36||0.4009|TWO_SIDED|95.0|-0.4|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced activity||1.0|-0.4|0.4009
71935600|NCT01271933|143392295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.35||0.0695|TWO_SIDED|95.0|-0.1|1.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced motivation||1.3|-0.1|0.0695
71935601|NCT01271933|143392295|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.27||0.5869|TWO_SIDED|95.0|-0.7|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental fatigue||0.4|-0.7|0.5869
71935602|NCT01271933|143392297|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.29||||0.0296|TWO_SIDED|95.0|1.09|4.81||Nominal p-value for two-sided test.|two-sided test|||This analysis is for the domain: Benefit from treatment||4.81|1.09|0.0296
71935603|NCT01271933|143392297|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.29||||0.4691|TWO_SIDED|95.0|0.64|2.61||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Satisfaction from treatment||2.61|0.64|0.4691
71935604|NCT01271933|143392297|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.98||||0.9577|TWO_SIDED|95.0|0.48|2.01||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Willingness to continue treatment||2.01|0.48|0.9577
71935605|NCT01271933|143392299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|19.3|STANDARD_ERROR_OF_MEAN|9.85||0.0562|TWO_SIDED|95.0|-0.5|39.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Work Time Missed||39.2|-0.5|0.0562
71935606|NCT01271933|143392299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1|STANDARD_ERROR_OF_MEAN|3.96||0.7892|TWO_SIDED|95.0|-7.0|9.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Impairment While Working||9.2|-7.0|0.7892
71935607|NCT01271933|143392299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|1.82||0.0819|TWO_SIDED|95.0|-0.4|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Activity Impairment||6.8|-0.4|0.0819
71935608|NCT01271933|143392299|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6|STANDARD_ERROR_OF_MEAN|1.91||0.4135|TWO_SIDED|95.0|-2.2|5.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Overall Work Impairment||5.4|-2.2|0.4135
71935609|NCT01271933|143392310|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.24||0.1224|TWO_SIDED|95.0|-0.1|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.9|-0.1|0.1224
71935610|NCT01271933|143392311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.06||0.768|TWO_SIDED|95.0|-9.3|6.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||6.9|-9.3|0.7680
71935611|NCT01271933|143392312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.29||0.136|TWO_SIDED|95.0|-4.5|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||0.6|-4.5|0.1360
71935612|NCT01271933|143392313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6489.5|STANDARD_ERROR_OF_MEAN|12579.5||0.6077|TWO_SIDED|95.0|-18648.6|31627.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Total daytime activity||31627.6|-18648.6|0.6077
71935613|NCT01271933|143392314|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|1.38||0.6647|TWO_SIDED|95.0|-2.2|3.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||||3.4|-2.2|0.6647
71935614|NCT00591253|143392350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0||||0.001|TWO_SIDED|95.0|-7.97|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.04|-7.97|0.001
71691732|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for change in number of Primary Health Care Provider Visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.838
71935615|NCT00591253|143392350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.78|||<|0.001|TWO_SIDED|95.0|-10.69|-4.86||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-4.86|-10.69|<0.001
71935616|NCT00591253|143392351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.48|||<|0.001|TWO_SIDED|95.0|-10.18|-2.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.78|-10.18|<0.001
71935617|NCT00591253|143392351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.54|||<|0.001|TWO_SIDED|95.0|-10.27|-2.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA|||||-2.81|-10.27|<0.001
71935618|NCT00591253|143392352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44||||0.001|TWO_SIDED|95.0|-5.47|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.40|-5.47|0.001
71935619|NCT00591253|143392352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.77|||<|0.001|TWO_SIDED|95.0|-7.78|-3.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.77|-7.78|<0.001
71935620|NCT00591253|143392353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12||||0.004|TWO_SIDED|95.0|-5.22|-1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.02|-5.22|0.004
71935621|NCT00591253|143392353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.96||||0.006|TWO_SIDED|95.0|-5.08|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.84|-5.08|0.006
71935622|NCT00591253|143392354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.09||||0.001|TWO_SIDED|95.0|-8.14|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.04|-8.14|0.001
71935623|NCT00591253|143392354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.97|||<|0.001|TWO_SIDED|95.0|-10.96|-4.97||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.97|-10.96|<0.001
71935624|NCT00591253|143392355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.74|||<|0.001|TWO_SIDED|95.0|-5.86|-1.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.61|-5.86|<0.001
71935625|NCT00591253|143392355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.9|||<|0.001|TWO_SIDED|95.0|-7.99|-3.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.81|-7.99|<0.001
71935626|NCT00591253|143392356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.91||||0.008|TWO_SIDED|95.0|-8.54|-1.27||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.27|-8.54|0.008
71935627|NCT00591253|143392356|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.27|||<|0.001|TWO_SIDED|95.0|-10.85|-3.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.69|-10.85|<0.001
71935628|NCT00591253|143392357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.05||||0.024|TWO_SIDED|95.0|-5.69|-0.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.40|-5.69|0.024
71935629|NCT00591253|143392357|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.79|||<|0.001|TWO_SIDED|95.0|-8.39|-3.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.19|-8.39|<0.001
71935630|NCT00591253|143392358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3||||0.001|TWO_SIDED|95.0|-8.52|-2.08||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-2.08|-8.52|0.001
71935631|NCT00591253|143392358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.71|||<|0.001|TWO_SIDED|95.0|-10.88|-4.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.55|-10.88|<0.001
71935632|NCT00591253|143392359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.81||||0.001|TWO_SIDED|95.0|-6.08|-1.54||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.54|-6.08|0.001
71935633|NCT00591253|143392359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|||<|0.001|TWO_SIDED|95.0|-7.88|-3.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-3.41|-7.88|<0.001
71935634|NCT00591253|143392360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.86||||0.014|TWO_SIDED|95.0|-8.72|-1.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-1.01|-8.72|0.014
71935635|NCT00591253|143392360|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|||<|0.001|TWO_SIDED|95.0|-12.5|-4.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.92|-12.50|<0.001
71935636|NCT00591253|143392361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.04||||0.012|TWO_SIDED|95.0|-7.17|-0.91||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-0.91|-7.17|0.012
71935637|NCT00591253|143392361|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.55|||<|0.001|TWO_SIDED|95.0|-10.63|-4.48||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA|||||-4.48|-10.63|<0.001
71935638|NCT00591253|143392362|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.15||||0.004|TWO_SIDED|95.0|1.27|3.65||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.65|1.27|0.004
71935639|NCT00591253|143392362|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.93||||0.016|TWO_SIDED|95.0|1.13|3.31||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.31|1.13|0.016
71935640|NCT00591253|143392363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.018|TWO_SIDED|95.0|1.11|3.08||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.08|1.11|0.018
71691733|NCT00105989|142898591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691734|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P-value for change in number of Psychologist/Therapist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.236
71935641|NCT00591253|143392363|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.89||||0.015|TWO_SIDED|95.0|1.13|3.16||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||3.16|1.13|0.015
71935642|NCT00591253|143392364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.35||||0.004|TWO_SIDED|95.0|1.31|4.24||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||4.24|1.31|0.004
71935643|NCT00591253|143392364|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.84|||<|0.001|TWO_SIDED|95.0|1.57|5.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|||||5.13|1.57|<0.001
71691735|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.145||95.0||||P-value for change in number of Other Specialist Physician visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.145
71935644|NCT01365845|143392367|SUPERIORITY_OR_OTHER||Non-parametric paired t-test (Wilcoxon)|29.1||||0.0078|||||||Wilcoxon (Mann-Whitney)|||||||0.0078
71935645|NCT02110706|143392372|OTHER|"A futility (non-superiority) design is a screening tool to identify whether agents should be candidates for phase III trials while minimizing costs/sample size If futility is declared, results would imply not cost effective to conduct a future phase III clinical trial If futility is not declared, suggests that there could be a clinically meaningful effect - supports exploration in a larger, phase III trial"|Odds Ratio (OR)|1.14||||0.03|ONE_SIDED|90.0||2.41|||Regression, Logistic|||"This futility design tests the following hypothesis:~H0: Rituximab improves outcome by at least 30% compared to placebo (pR - pP ≥ 0.30 - not futile) versus HA: Rituximab does not improve outcome by at least 30% compared to placebo (pR - pP \< 0.30 - futile)"||2.41||0.03
71935646|NCT02110706|143392373|SUPERIORITY||Odds Ratio (OR)|0.72||||0.63|TWO_SIDED|90.0|0.23|2.21|||t-test, 2 sided|||% of study participants with treatment related AEs||2.21|0.23|0.63
71691736|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.423||95.0||||P-value for change in number of Other (Specified by Patient) visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.423
71691737|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.325||95.0||||P-value for change in number of Primary Health Care Provider visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.325
71935647|NCT02110706|143392373|SUPERIORITY||Odds Ratio (OR)|0.75||||0.65|TWO_SIDED|90.0|0.27|2.11|||t-test, 2 sided|||% study participants with treatment related SAEs||2.11|0.27|0.65
71935648|NCT02110706|143392374|OTHER||Mean Difference (Final Values)|-0.11||||0.93|ONE_SIDED|90.0||2.02|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the MGC. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline MGC scores.||2.02||0.93
71935649|NCT02110706|143392375|OTHER||Mean Difference (Final Values)|-1.09||||0.39|ONE_SIDED|90.0||1.03|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the QMG. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline QMG scores.||1.03||0.39
71935650|NCT03210259|143392376|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the least squares (LS) means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|105.19|||||TWO_SIDED|90.2|96.58|114.64|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||114.64|96.58|
71935651|NCT03210259|143392377|EQUIVALENCE|Equivalence was concluded if the confidence interval (CI) for the LS means ratio was included in the pre-defined equivalence range of 80.00% to 125.00%.|Least squares means ratio|101.14|||||TWO_SIDED|90.2|93.26|109.7|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm in the numerator and the continuous arm in the denominator.|The null hypothesis was that the ratio of expected means for Switching vs. Continuous Humira is less than 80.00% or more than 125.00%.||109.70|93.26|
71935652|NCT03210259|143392378|OTHER||Least squares means ratio|107.31|||||TWO_SIDED|90.2|97.33|118.43|||||The least squares means were from ANCOVA. Ratio was calculated with the switching arm as numerator and the continuous arm as the denominator.|No hypothesis was defined and no statistical test was performed.||118.43|97.33|
71935653|NCT03210259|143392380|OTHER||Risk Difference (RD)|5.75|||||TWO_SIDED|90.0|-2.45|13.96|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||13.96|-2.45|
71935654|NCT03210259|143392381|OTHER||Risk Difference (RD)|5.63|||||TWO_SIDED|90.0|-4.35|15.62|||||Risk difference was calculated as Switching arm minus Continuous Humira.|No hypothesis was tested.||15.62|-4.35|
71935655|NCT00252187|143392392|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||Chi-squared|||Change in end systolic LV volume index compared between two groups||||0.004
71935656|NCT00252187|143392392|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||Change in LV end diastolic volume was compared between two groups||||0.001
71935657|NCT00252187|143392393|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Chi-squared|||||||0.001
71935658|NCT00252187|143392395|SUPERIORITY_OR_OTHER|||||||0.14||95.0|||||Chi-squared|||||||0.14
71935659|NCT00252187|143392396|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Chi-squared|||||||0.006
71935660|NCT03764059|143392400|NON_INFERIORITY|The test for non-inferiority is based on a 95% CI of the difference between the investigational and control groups with respect to the rate of clinically acceptable restorations at 1-year post placement. The non-inferiority margin was 7%. To establish non-inferiority the lower limit has to be \> -7%|Risk Difference (RD)|4.2|||<|0.0001|TWO_SIDED|95.0||9.2|||Cochran-Mantel-Haenszel|||||9.2|- 0.6|< 0.0001
71935661|NCT01261325|143392453|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|22.8|||<|0.001|TWO_SIDED|95.0|13.3|31.2||"Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant or similar, as accurate and appropriate."|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.2|13.3|<0.001
71935662|NCT01261325|143392453|SUPERIORITY_OR_OTHER_LEGACY||Percent reduction over PBO|23.2|||<|0.001|TWO_SIDED|95.0|13.8|31.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||31.6|13.8|<0.001
71935663|NCT01261325|143392454|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.39|||<|0.001|TWO_SIDED|95.0|1.6|3.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.6|1.6|<0.001
71935664|NCT01261325|143392454|SUPERIORITY_OR_OTHER_LEGACY||Odds ratio (BRV versus PBO)|2.19|||<|0.001|TWO_SIDED|95.0|1.5|3.3||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||3.3|1.5|<0.001
71935665|NCT01261325|143392455|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|15.8|||<|0.001|TWO_SIDED|95.0|7.6|24.2||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||24.2|7.6|<0.001
71935666|NCT01261325|143392455|SUPERIORITY_OR_OTHER_LEGACY||Median difference vs placebo|18.1|||<|0.001|TWO_SIDED|95.0|10.4|26.4||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.|||26.4|10.4|<0.001
71935667|NCT01261325|143392459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67|||<|0.001|TWO_SIDED|95.0|0.56|0.82||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.82|0.56|<0.001
71935668|NCT01261325|143392459|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.54|0.79||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.79|0.54|<0.001
71935669|NCT01261325|143392460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.65|||<|0.001|TWO_SIDED|95.0|0.53|0.8||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.80|0.53|<0.001
71935670|NCT01261325|143392460|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|0.001|TWO_SIDED|95.0|0.47|0.71||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.|||0.71|0.47|<0.001
71935671|NCT01261325|143392461|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.75||||0.009|TWO_SIDED|95.0|0.6|0.93||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.93|0.60|0.009
71935672|NCT01261325|143392461|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.85||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.||||0.85|0.55|<0.001
71935673|NCT02524106|143392466|OTHER||percentage difference|61.0||||0.028|TWO_SIDED||||||Mixed Models Analysis|||||||0.028
71935674|NCT02524106|143392467|OTHER||percentage difference|39.0||||0.096|TWO_SIDED||||||Mixed Models Analysis|||||||0.096
71935675|NCT00990561|143392469|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||Null hypothesis = there is no difference between using ultravate once daily vs. twice daily||||<0.001
71935676|NCT03558997|143392501|SUPERIORITY||Least Square (LS) Mean Difference|4.73||||0.7185|TWO_SIDED|95.0|-21.023|30.487|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.487|-21.023|0.7185
71935677|NCT03558997|143392502|SUPERIORITY||Least Square (LS) Mean Difference|0.3||||0.5438|TWO_SIDED|95.0|-0.661|1.254|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||1.254|-0.661|0.5438
71935678|NCT03558997|143392503|SUPERIORITY||Least Square (LS) Mean Difference|0.03||||0.9559|TWO_SIDED|95.0|-0.877|0.928|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||0.928|-0.877|0.9559
71935679|NCT03558997|143392504|SUPERIORITY||Least Square (LS) Mean Difference|7.25||||0.5416|TWO_SIDED|95.0|-16.028|30.53|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||30.530|-16.028|0.5416
71935680|NCT03558997|143392505|SUPERIORITY||Least Square (LS) Mean Difference|-0.94||||0.0414|TWO_SIDED|95.0|-1.848|-0.037|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-0.037|-1.848|0.0414
71935681|NCT03558997|143392506|SUPERIORITY||Least Square (LS) Mean Difference|-30.45||||0.0108|TWO_SIDED|95.0|-53.874|-7.034|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.|||-7.034|-53.874|0.0108
71935682|NCT03558997|143392507|SUPERIORITY||Median Difference|0.665||||0.1449|TWO_SIDED|95.0|-0.77|3.21|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||3.2100|-0.770|0.1449
71935683|NCT03558997|143392508|SUPERIORITY||Median Difference|335.3||||0.1231|TWO_SIDED|95.0|-551.47|1746.55|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1746.55|-551.47|0.1231
71935684|NCT03558997|143392509|SUPERIORITY||Median Difference|-13.325|||<|0.0001|TWO_SIDED|95.0|-23.94|-8.36|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-8.3600|-23.9400|<0.0001
71935685|NCT03558997|143392510|SUPERIORITY||Median Difference|-134.6|||<|0.0001|TWO_SIDED|95.0|-205.51|-94.98|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||-94.98|-205.51|<0.0001
71691738|NCT00105989|142898591|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for change in number of Psychiatrist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691739|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.915||95.0||||P-value for change in number of Psychologist/Therapist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.915
71691740|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.223||95.0||||P-value for change in number of Other Specialist Physician visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.223
71691741|NCT00105989|142898591|SUPERIORITY_OR_OTHER|||||||0.362||95.0||||P-value for change in number of Other (Specified by Patient) visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.362
71691742|NCT00105989|142898592|SUPERIORITY_OR_OTHER|||||||0.462||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Primary Health Care Provider visits.|t-test, 2 sided|||||||0.462
71691743|NCT00105989|142898592|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychiatrist visits.|t-test, 2 sided|||||||0.668
71691744|NCT00105989|142898592|SUPERIORITY_OR_OTHER|||||||0.746||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychologist/Therapist visits.|t-test, 2 sided|||||||0.746
71691745|NCT00105989|142898592|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other Specialist Physician visits.|t-test, 2 sided|||||||0.511
71935686|NCT03558997|143392511|SUPERIORITY||Median Difference|0.84|||<|0.0001|TWO_SIDED|95.0|0.45|1.27|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate \& treatment as fixed factors. Median difference \& its 95% CI estimated with Hodges-Lehmann method.|||1.2700|0.4500|<0.0001
71691746|NCT00105989|142898592|SUPERIORITY_OR_OTHER|||||||0.271||95.0||||P-value for pairwise comparison of means for change from baseline to endpoint in Other (Specified by Patient) Provider visits.|t-test, 2 sided|||||||0.271
71691747|NCT00105989|142898593|SUPERIORITY_OR_OTHER|||||||0.506||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.506
71691748|NCT00105989|142898593|SUPERIORITY_OR_OTHER|||||||0.057||95.0||||P-value for Change in Average Number of Hours Worked In a Week in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.057
71935687|NCT02033876|143392513|SUPERIORITY|||||||0.43|||||||ANCOVA|||||||0.43
71935688|NCT02033876|143392514|SUPERIORITY|||||||0.65|||||||ANCOVA|||||||0.65
71691749|NCT00105989|142898594|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||t-test, 2 sided|||||||0.826
71691750|NCT00105989|142898595|SUPERIORITY_OR_OTHER|||||||0.105||95.0||||P-value for Change in Number of Missed Paid Work Hours in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.105
71691751|NCT00105989|142898595|SUPERIORITY_OR_OTHER|||||||0.174||95.0||||P-value for Change in Number of Missed Paid Work Hours in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.174
71691752|NCT00105989|142898596|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||t-test, 2 sided|||||||0.037
71691753|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.785
71691754|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.354||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.354
71691755|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.170
71691756|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.825||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.825
71691757|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.877||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.877
71691758|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.009
71691759|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.670
71691760|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.100
71691761|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.021
71935689|NCT02033876|143392516|SUPERIORITY|||||||0.37|||||||ANCOVA|||||||0.37
71935690|NCT02033876|143392517|SUPERIORITY|||||||0.51|||||||ANCOVA|||||||0.51
71935691|NCT02033876|143392518|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||0.4
71935692|NCT02033876|143392519|SUPERIORITY|||||||0.8|||||||ANCOVA|||||||0.8
71935693|NCT02033876|143392520|SUPERIORITY|||||||0.006|||||||ANCOVA|||||||0.006
71691762|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.047||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.047
71691763|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.023
71691764|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.668
71691765|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.136||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.136
71691766|NCT00105989|142898597|SUPERIORITY_OR_OTHER|||||||0.152||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.152
71691767|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691768|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691769|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691770|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691771|NCT00105989|142898598|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.005
71691772|NCT00105989|142898598|SUPERIORITY_OR_OTHER|||||||0.05||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.050
71691773|NCT00105989|142898598|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.022
71691774|NCT00105989|142898598|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.002
71691775|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Sum Items 1\&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691776|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691777|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691778|NCT00105989|142898598|SUPERIORITY_OR_OTHER|||||||0.186||95.0||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.186
71691779|NCT00105989|142898598|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691780|NCT00105989|142898598|SUPERIORITY_OR_OTHER|||||||0.308||95.0||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.308
71691781|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.773
71691782|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.405||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.405
71691783|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.443||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.443
71691784|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.384||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.384
71691785|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.268||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.268
71691786|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.093||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.093
71691787|NCT00105989|142898599|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.566
71691788|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.979||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided|||||||0.979
71935694|NCT01360632|143392526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0925|TWO_SIDED|95.0|-2.58|0.2|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||0.2|-2.58|0.0925
71691789|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.132||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided|||||||0.132
71691790|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided|||||||0.180
71691791|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided|||||||0.163
71691792|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.844||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided|||||||0.844
71691793|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided|||||||0.609
71691794|NCT00105989|142898600|SUPERIORITY_OR_OTHER|||||||0.071||95.0||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided|||||||0.071
71691795|NCT00105989|142898601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691796|NCT00105989|142898601|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691797|NCT00105989|142898602|SUPERIORITY_OR_OTHER|||||||0.314||95.0|||||t-test, 2 sided|||||||0.314
71935695|NCT01360632|143392526|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.0327|TWO_SIDED|95.0|-2.92|-0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.||-0.13|-2.92|0.0327
71691798|NCT00105989|142898603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691799|NCT00105989|142898603|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<0.001
71691800|NCT00105989|142898604|SUPERIORITY_OR_OTHER|||||||0.891||95.0|||||t-test, 2 sided|||||||0.891
71691801|NCT00105989|142898605|SUPERIORITY_OR_OTHER|||||||0.659||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.659
71691802|NCT00105989|142898605|SUPERIORITY_OR_OTHER|||||||0.064||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.064
71691803|NCT00105989|142898605|SUPERIORITY_OR_OTHER|||||||0.224||95.0||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.224
71691804|NCT00105989|142898605|SUPERIORITY_OR_OTHER|||||||0.21||95.0||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||0.210
71691805|NCT00105989|142898606|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||P-value for Change from Baseline: systolic blood pressure.|t-test, 2 sided|||||||0.134
71691806|NCT00105989|142898606|SUPERIORITY_OR_OTHER|||||||0.816||95.0||||P-value for Change from Baseline: diastolic blood pressure.|t-test, 2 sided|||||||0.816
71691807|NCT00105989|142898607|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691808|NCT00105989|142898608|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.007
71691809|NCT00105989|142898609|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.035
71691810|NCT00105989|142898610|SUPERIORITY_OR_OTHER|||||||0.021||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
71691811|NCT00105989|142898611|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691812|NCT00105989|142898612|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.019
71691813|NCT00105989|142898613|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.005
71691814|NCT00105989|142898614|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.031
71691815|NCT00105989|142898615|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691816|NCT00105989|142898616|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691817|NCT00105989|142898617|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691818|NCT00105989|142898618|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691819|NCT00105989|142898619|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691820|NCT00105989|142898620|SUPERIORITY_OR_OTHER|||||||0.004||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.004
71935696|NCT01360632|143392527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3||||0.0737|TWO_SIDED|95.0|-2.73|0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.13|-2.73|0.0737
71691821|NCT00105989|142898621|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.010
71935697|NCT01360632|143392527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95||||0.0079|TWO_SIDED|95.0|-3.39|-0.51|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.51|-3.39|0.0079
71935698|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.06||||0.0096|TWO_SIDED|95.0|-1.86|-0.26|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.26|-1.86|0.0096
71935699|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.4137|TWO_SIDED|95.0|-1.14|0.47|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.47|-1.14|0.4137
71935700|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.44||||0.0065|TWO_SIDED|95.0|-2.47|-0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.4|-2.47|0.0065
71935701|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.0914|TWO_SIDED|95.0|-1.93|0.14|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.14|-1.93|0.0914
71935702|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.0139|TWO_SIDED|95.0|-2.5|-0.28|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.28|-2.5|0.0139
71935703|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.71||||0.2097|TWO_SIDED|95.0|-1.82|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.4|-1.82|0.2097
71935704|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0099|TWO_SIDED|95.0|-2.75|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.38|-2.75|0.0099
71935705|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29||||0.034|TWO_SIDED|95.0|-2.48|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.1|-2.48|0.034
71935706|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0177|TWO_SIDED|95.0|-2.8|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.27|-2.8|0.0177
71935707|NCT01360632|143392528|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.71||||0.0085|TWO_SIDED|95.0|-2.98|-0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.44|-2.98|0.0085
71935708|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.92||||0.0286|TWO_SIDED|95.0|-1.74|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.1|-1.74|0.0286
71935709|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.3173|TWO_SIDED|95.0|-1.24|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.4|-1.24|0.3173
71935710|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0313|TWO_SIDED|95.0|-2.23|-0.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.11|-2.23|0.0313
71935711|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.97||||0.0732|TWO_SIDED|95.0|-2.04|0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.09|-2.04|0.0732
71935712|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.36||||0.0206|TWO_SIDED|95.0|-2.51|-0.21|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.21|-2.51|0.0206
71935713|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.91||||0.1233|TWO_SIDED|95.0|-2.06|0.25|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.25|-2.06|0.1233
71935714|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.0097|TWO_SIDED|95.0|-2.84|-0.39|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.39|-2.84|0.0097
71935715|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0092|TWO_SIDED|95.0|-2.86|-0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.41|-2.86|0.0092
71935716|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0139|TWO_SIDED|95.0|-2.94|-0.33|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.33|-2.94|0.0139
71935717|NCT01360632|143392529|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.12||||0.0015|TWO_SIDED|95.0|-3.42|-0.81|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.81|-3.42|0.0015
71935718|NCT01360632|143392530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0008|TWO_SIDED|95.0|-0.87|-0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.23|-0.87|0.0008
71935719|NCT01360632|143392530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.5792|TWO_SIDED|95.0|-0.41|0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B||0.23|-0.41|0.5792
71691822|NCT00105989|142898622|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.003
71935720|NCT01360632|143392530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0091|TWO_SIDED|95.0|-0.87|-0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.12|-0.87|0.0091
71935721|NCT01360632|143392530|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0474|TWO_SIDED|95.0|-0.73|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.73|0.0474
71935722|NCT01360632|143392531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.0015|TWO_SIDED|95.0|-0.94|-0.22||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.22|-0.94|0.0015
71935723|NCT01360632|143392531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.2627|TWO_SIDED|95.0|-0.56|0.15||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate|Mixed Models Analysis|||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.15|-0.56|0.2627
71935724|NCT01360632|143392531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0158|TWO_SIDED|95.0|-0.89|-0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3||-0.09|-0.89|0.0158
71935725|NCT01360632|143392531|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0191|TWO_SIDED|95.0|-0.88|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.08|-0.88|0.0191
71935726|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.0377|TWO_SIDED|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11||-0.03|-0.88|0.0377
71935727|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0741|TWO_SIDED|95.0|-0.91|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis||-0.43|For Item: Work/School: Week 14||0.04|-0.91|0.0741
71935728|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.0966|TWO_SIDED|95.0|-0.07|0.81||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||For Item: Work/School: Week 11||0.81|-0.07|0.0966
71935729|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.4774|TWO_SIDED|95.0|-0.66|0.31|||Mixed Models Analysis|||For Item: Work/School: Week 14||0.31|-0.66|0.4774
71935730|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0263|TWO_SIDED|95.0|-0.76|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.05|-0.76|0.0263
71935731|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0214|TWO_SIDED|95.0|-0.89|-0.07|||Mixed Models Analysis|||Social life: Week 14||-0.07|-0.89|0.0214
71935732|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.8281|TWO_SIDED|95.0|-0.4|0.32||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.32|-0.40|0.8281
71935733|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.054|TWO_SIDED|95.0|-0.8|0.01|||Mixed Models Analysis|||Social life: Week 14||0.01|-0.80|0.0540
71935734|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.0008|TWO_SIDED|95.0|-0.99|-0.26||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.26|-0.99|0.0008
71935735|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.0093|TWO_SIDED|95.0|-0.97|-0.14|||Mixed Models Analysis|||Family life: Week 14||-0.14|-0.97|0.0093
71935736|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.2182|TWO_SIDED|95.0|-0.59|0.14|||Mixed Models Analysis|||Family life: Week 11||0.14|-0.59|0.2182
71935737|NCT01360632|143392532|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48||||0.0256|TWO_SIDED|95.0|-0.9|-0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.06|-0.90|0.0256
71935738|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0341|TWO_SIDED|95.0|-1.01|-0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||-0.04|-1.01|0.0341
71935739|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.46||||0.0816|TWO_SIDED|95.0|-0.99|0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||School/work: Week 14||0.06|-0.99|0.0816
71935740|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.2561|TWO_SIDED|95.0|-0.21|0.78||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11||0.78|-0.21|0.2561
71935741|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.2952|TWO_SIDED|95.0|-0.82|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 14||0.25|-0.82|0.2952
71935742|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.0331|TWO_SIDED|95.0|-0.82|-0.03||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||-0.03|-0.82|0.0331
71935743|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.0352|TWO_SIDED|95.0|-0.9|-0.03|||Mixed Models Analysis|||Social life: Week 14||-0.03|-0.90|0.0352
71935744|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.486|TWO_SIDED|95.0|-0.54|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11||0.25|-0.54|0.4860
71935745|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.0282|TWO_SIDED|95.0|-0.93|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 14||-0.05|-0.93|0.0282
71935746|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62||||0.0016|TWO_SIDED|95.0|-1.01|-0.24||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||-0.24|-1.01|0.0016
71935747|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.0186|TWO_SIDED|95.0|-0.94|-0.09|||Mixed Models Analysis|||Family life: Week 14||-0.09|-0.94|0.0186
71935748|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0824|TWO_SIDED|95.0|-0.73|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11||0.04|-0.73|0.0824
71935749|NCT01360632|143392533|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.0077|TWO_SIDED|95.0|-1.02|-0.16||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14||-0.16|-1.02|0.0077
71935750|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.0436|TWO_SIDED|95.0|-0.18|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.18|0.0436
71935751|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||-0.06|TWO_SIDED|95.0|-0.15|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.03|-0.15|-0.06
71935752|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0012|TWO_SIDED|95.0|-0.34|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.08|-0.34|0.0012
71935753|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0266|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.02|-0.27|0.0266
71935754|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0034|TWO_SIDED|95.0|-0.33|-0.07|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.07|-0.33|0.0034
71935755|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.3053|TWO_SIDED|95.0|-0.2|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.2|0.3053
71935756|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0541|TWO_SIDED|95.0|-0.29|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0|-0.29|0.0541
71935757|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0912|TWO_SIDED|95.0|-0.28|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.28|0.0912
71935758|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.1553|TWO_SIDED|95.0|-0.28|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.04|-0.28|0.1553
71935759|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.1855|TWO_SIDED|95.0|-0.27|0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.05|-0.27|0.1855
71935760|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.2015|TWO_SIDED|95.0|-0.28|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.06|-0.28|0.2015
71935761|NCT01360632|143392534|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0852|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.02|-0.32|0.0852
71935762|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.08||||0.0817|TWO_SIDED|95.0|-0.17|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.17|0.0817
71935763|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.1406|TWO_SIDED|95.0|-0.16|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.16|0.1406
71935764|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.011|TWO_SIDED|95.0|-0.29|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-0.29|0.011
71935765|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0287|TWO_SIDED|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.02|-0.27|0.0287
71935766|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0071|TWO_SIDED|95.0|-0.32|-0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.05|-0.32|0.0071
71935767|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.2503|TWO_SIDED|95.0|-0.22|-0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.06|-0.22|0.2503
71935768|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.0539|TWO_SIDED|95.0|-0.3|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-0.3|0.0539
71935769|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0398|TWO_SIDED|95.0|-0.31|-0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.01|-0.31|0.0398
71935770|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.1168|TWO_SIDED|95.0|-0.3|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.03|-0.3|0.1168
71935771|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0621|TWO_SIDED|95.0|-0.32|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.01|-0.32|0.0621
71935772|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.089|TWO_SIDED|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.02|-0.32|0.089
71935773|NCT01360632|143392535|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0213|TWO_SIDED|95.0|-0.38|-0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.03|-0.38|0.0213
71935774|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0228|TWO_SIDED|95.0|-2.37|-0.18|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.18|-2.37|0.0228
71935775|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.5081|TWO_SIDED|95.0|-1.47|0.73|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.73|-1.47|0.5081
71935776|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0064|TWO_SIDED|95.0|-3.2|-0.53|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.53|-3.2|0.0064
71935777|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89||||0.1898|TWO_SIDED|95.0|-2.23|0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.44|-2.23|0.1898
71935778|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.09||||0.0074|TWO_SIDED|95.0|-3.62|-0.56|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.56|-3.62|0.0074
71935779|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.5935|TWO_SIDED|95.0|-1.95|1.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||1.11|-1.95|0.5935
71935780|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0211|TWO_SIDED|95.0|-3.52|-0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||-0.29|-3.52|0.0211
71935781|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.1031|TWO_SIDED|95.0|-2.96|0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.27|-2.96|0.1031
71935782|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1366||||0.1366|TWO_SIDED|95.0|-3.02|0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.41|-3.02|0.1366
71691823|NCT00105989|142898623|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71935783|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.2709|TWO_SIDED|95.0|-2.68|0.75|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.75|-2.68|0.2709
71935784|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.0812|TWO_SIDED|95.0|-3.4|0.2|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.2|-3.4|0.0812
71935785|NCT01360632|143392536|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.52||||0.1001|TWO_SIDED|95.0|-3.33|0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.||0.29|-3.33|0.1001
71935786|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12||||0.0496|TWO_SIDED|95.0|-2.24|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0|-2.24|0.0496
71691824|NCT00105989|142898624|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.015
71935787|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.387|TWO_SIDED|95.0|-1.61|0.63|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.63|-1.61|0.387
71935788|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.75||||0.0125|TWO_SIDED|95.0|-3.13|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.38|-3.13|0.0125
71935789|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19||||0.0898|TWO_SIDED|95.0|-2.57|0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.19|-2.57|0.0898
71935790|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31||||0.004|TWO_SIDED|95.0|-3.88|-0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.74|-3.88|0.004
71935791|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83||||0.301|TWO_SIDED|95.0|-2.4|0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.74|-2.4|0.301
71935792|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15||||0.0118|TWO_SIDED|95.0|-3.82|-0.48|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.48|-3.82|0.0118
71935793|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.0287|TWO_SIDED|95.0|-3.54|-0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.19|-3.54|0.0287
71935794|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0686|TWO_SIDED|95.0|-3.39|0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.12|-3.39|0.0686
71935795|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.72||||0.056|TWO_SIDED|95.0|-3.47|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||0.04|-3.47|0.056
71691825|NCT00105989|142898625|SUPERIORITY_OR_OTHER|||||||0.021||95.0||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.021
71935796|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.0448|TWO_SIDED|95.0|-3.75|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.04|-3.75|0.0448
71935797|NCT01360632|143392537|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.13||||0.0251|TWO_SIDED|95.0|-3.98|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.||-0.27|-3.98|0.0251
71935798|NCT01360632|143392538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.1732|TWO_SIDED|95.0|-1.63|0.29|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||0.29|-1.63|0.1732
71935799|NCT01360632|143392538|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0066|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.||-0.37|-2.31|0.0066
71935800|NCT01360632|143392539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.1226|TWO_SIDED|95.0|-1.78|0.21|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.21|-1.78|0.1226
71935801|NCT01360632|143392539|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.001|TWO_SIDED|95.0|-2.69|-0.68|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.68|-2.69|0.001
71935802|NCT01360632|143392540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.8164|TWO_SIDED|95.0|-0.93|0.73|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.73|-0.93|0.8164
71935803|NCT01360632|143392540|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1939|TWO_SIDED|95.0|-1.39|0.28|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.28|-1.39|0.1939
71935804|NCT01360632|143392541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.5192|TWO_SIDED|95.0|-1.14|0.57|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.57|-1.14|0.5192
71935805|NCT01360632|143392541|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0443|TWO_SIDED|95.0|-1.75|-0.02|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.02|-1.75|0.0443
71935806|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0248|TWO_SIDED|95.0|-0.26|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.26|0.0248
71935807|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.1334|TWO_SIDED|95.0|-0.22|0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.03|-0.22|0.1334
71935808|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
71935809|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0019|TWO_SIDED|95.0|-0.38|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.09|-0.38|0.0019
71935810|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0009|TWO_SIDED|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.11|-0.42|0.0009
71935811|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.0254|TWO_SIDED|95.0|-0.34|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.02|-0.34|0.0254
71935812|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0035|TWO_SIDED|95.0|-0.41|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.41|0.0035
71935813|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0152|TWO_SIDED|95.0|-0.39|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.04|-0.39|0.0152
71935814|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.004|TWO_SIDED|95.0|-0.42|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.08|-0.42|0.004
71935815|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.013|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||-0.05|-0.42|0.013
71935816|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.16||||0.0755|TWO_SIDED|95.0|-0.33|0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.02|-0.33|0.0755
71935817|NCT01360632|143392542|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.0527|TWO_SIDED|95.0|-0.39|0.0|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0|-0.39|0.0527
71935818|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.0275|TWO_SIDED|95.0|-0.26|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.01|-0.26|0.0275
71935819|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.1583|TWO_SIDED|95.0|-0.22|0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.04|-0.22|0.1583
71935820|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0021|TWO_SIDED|95.0|-0.41|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.41|0.0021
71935821|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0018|TWO_SIDED|95.0|-0.4|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.4|0.0018
71935822|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0011|TWO_SIDED|95.0|-0.43|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.11|-0.43|0.0011
71935823|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.19||||0.0235|TWO_SIDED|95.0|-0.36|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.36|0.0235
71935824|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.27||||0.0021|TWO_SIDED|95.0|-0.44|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.10|-0.44|0.0021
71935825|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.0111|TWO_SIDED|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.05|-0.42|0.0111
71935826|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.44|0.0030
71935827|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0046|TWO_SIDED|95.0|-0.47|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.09|-0.47|0.0046
71935828|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21||||0.0237|TWO_SIDED|95.0|-0.39|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.03|-0.39|0.0237
71935829|NCT01360632|143392543|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0171|TWO_SIDED|95.0|-0.45|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||-0.04|-0.45|0.0171
71935830|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.5279|TWO_SIDED|95.0|0.51|3.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.68|0.51|0.5279
71935831|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
71935832|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.92||||0.0484|TWO_SIDED|95.0|0.99|3.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.72|0.99|0.0484
71935833|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.5813|TWO_SIDED|95.0|0.6|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|0.60|0.5813
71691826|NCT00105989|142898626|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71935834|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.1236|TWO_SIDED|95.0|0.9|2.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.54|0.90|0.1236
71935835|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.4998|TWO_SIDED|95.0|0.7|2.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.10|0.70|0.4998
71935836|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.64||||0.0365|TWO_SIDED|95.0|1.03|2.61|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.61|1.03|0.0365
71935837|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.52||||0.0822|TWO_SIDED|95.0|0.95|2.43|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.43|0.95|0.0822
71935838|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.4049|TWO_SIDED|95.0|0.79|1.78|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.78|0.79|0.4049
71935839|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.23||||0.2951|TWO_SIDED|95.0|0.84|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.80|0.84|0.2951
71935840|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.53||||0.0248|TWO_SIDED|95.0|1.06|2.2|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.20|1.06|0.0248
71935841|NCT01360632|143392544|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0326|TWO_SIDED|95.0|1.03|2.21|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.21|1.03|0.0326
71935842|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|0.87||||0.7993|TWO_SIDED|95.0|0.3|2.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.55|0.30|0.7993
71935843|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
71935844|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.2825|TWO_SIDED|95.0|0.71|3.16|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.16|0.71|0.2825
71935845|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.2||||0.6375|TWO_SIDED|95.0|0.58|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|0.58|0.6375
71935846|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.0923|TWO_SIDED|95.0|0.92|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.92|0.0923
71935847|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.29||||0.3812|TWO_SIDED|95.0|0.73|2.3|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.30|0.73|0.3812
71935848|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.63||||0.0464|TWO_SIDED|95.0|1.0|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.65|1.00|0.0464
71935849|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.049|TWO_SIDED|95.0|1.0|2.64|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.64|1.00|0.0490
71935850|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.32||||0.2124|TWO_SIDED|95.0|0.85|2.06|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.06|0.85|0.2124
71935851|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.1078|TWO_SIDED|95.0|0.93|2.14|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.14|0.93|0.1078
71935852|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.69||||0.0094|TWO_SIDED|95.0|1.14|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.14|0.0094
71935853|NCT01360632|143392545|SUPERIORITY_OR_OTHER||Ratio of response rate|1.65||||0.0162|TWO_SIDED|95.0|1.09|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.50|1.09|0.0162
71935854|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of remission rate|1.03||||0.9498|TWO_SIDED|95.0|0.37|2.9|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.90|0.37|0.9498
71935855|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|0.13||||0.0141|TWO_SIDED|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||0.94|0.02|0.0141
71691827|NCT00105989|142898627|SUPERIORITY_OR_OTHER|||||||0.032||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.032
71935856|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|0.93||||0.8609|TWO_SIDED|95.0|0.4|2.17|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.17|0.40|0.8609
71935857|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.2846|TWO_SIDED|95.0|0.22|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.22|0.2846
71935858|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.5||||0.248|TWO_SIDED|95.0|0.75|2.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.99|0.75|0.2480
71935859|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.13||||0.7513|TWO_SIDED|95.0|0.54|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.37|0.54|0.7513
71935860|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.82||||0.0554|TWO_SIDED|95.0|0.99|3.35|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||3.35|0.99|0.0554
71935861|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2409|TWO_SIDED|95.0|0.76|2.87|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.87|0.76|0.2409
71935862|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.5538|TWO_SIDED|95.0|0.69|2.02|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.02|0.69|0.5538
71935863|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.44||||0.1743|TWO_SIDED|95.0|0.85|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.41|0.85|0.1743
71935864|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.3||||0.2843|TWO_SIDED|95.0|0.81|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.07|0.81|0.2843
71935865|NCT01360632|143392546|SUPERIORITY_OR_OTHER||Ratio of response rate|1.19||||0.464|TWO_SIDED|95.0|0.74|1.92|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.92|0.74|0.4640
71935866|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3867|TWO_SIDED|95.0|0.18|1.97|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.97|0.18|0.3867
71935867|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|0.11||||0.0118|TWO_SIDED|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||0.93|0.01|0.0118
71935868|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|0.59||||0.32|TWO_SIDED|95.0|0.21|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.66|0.21|0.3200
71935869|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|0.6||||0.3266|TWO_SIDED|95.0|0.23|1.62|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.62|0.23|0.3266
71935870|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.47||||0.3027|TWO_SIDED|95.0|0.7|3.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.10|0.70|0.3027
71935871|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.17||||0.696|TWO_SIDED|95.0|0.54|2.52|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.52|0.54|0.6960
71691828|NCT00105989|142898628|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691829|NCT00105989|142898629|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||<.001
71691830|NCT00105989|142898630|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.028
71691831|NCT00105989|142898631|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.008
71935872|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.62||||0.1368|TWO_SIDED|95.0|0.86|3.07||CMH general association test controlling for trial site|Cochran-Mantel-Haenszel|||Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||3.07|0.86|0.1368
71935873|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.48||||0.2387|TWO_SIDED|95.0|0.76|2.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.89|0.76|0.2387
71935874|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.26||||0.4498|TWO_SIDED|95.0|0.69|2.28|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.28|0.69|0.4498
71935875|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.6||||0.1009|TWO_SIDED|95.0|0.91|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.82|0.91|0.1009
71935876|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.45||||0.1499|TWO_SIDED|95.0|0.87|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.41|0.87|0.1499
71935877|NCT01360632|143392547|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3012|TWO_SIDED|95.0|0.78|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.18|0.78|0.3012
71935878|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.2873|TWO_SIDED|95.0|0.75|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.65|0.75|0.2873
71935879|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.2677|TWO_SIDED|95.0|0.79|2.36|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.36|0.79|0.2677
71935880|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.8||||0.0031|TWO_SIDED|95.0|1.21|2.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.68|1.21|0.0031
71935881|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.7||||0.0066|TWO_SIDED|95.0|1.15|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||2.50|1.15|0.0066
71935882|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.34||||0.0665|TWO_SIDED|95.0|0.98|1.83|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.83|0.98|0.0665
71935883|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.025|TWO_SIDED|95.0|1.05|1.91|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.91|1.05|0.0250
71935884|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.18||||0.2224|TWO_SIDED|95.0|0.9|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.54|0.90|0.2224
71935885|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.0369|TWO_SIDED|95.0|1.01|1.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.68|1.01|0.0369
71935886|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.36||||0.0179|TWO_SIDED|95.0|1.05|1.75|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.75|1.05|0.0179
71691832|NCT00105989|142898632|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.||||||.046
71935887|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.49||||0.0011|TWO_SIDED|95.0|1.17|1.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.89|1.17|0.0011
71935888|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.12||||0.3249|TWO_SIDED|95.0|0.89|1.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.41|0.89|0.3249
71691833|NCT00105989|142898633|SUPERIORITY_OR_OTHER|||||||0.035||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.035
71691834|NCT00105989|142898634|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.011
71691835|NCT00105989|142898635|SUPERIORITY_OR_OTHER|||||||0.744||95.0||||P-value for fasting glucose change from baseline to endpoint|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.744
71691836|NCT00105989|142898635|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||P-value for non-fasting glucose change from baseline to endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.||||||0.030
71691837|NCT00357877|142898638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25|STANDARD_ERROR_OF_MEAN|0.44||0.56|TWO_SIDED|95.0|-0.6|1.11||No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.|Regression, Linear|The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.||We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.||1.11|-0.60|0.56
71691838|NCT00357877|142898639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.35|STANDARD_ERROR_OF_MEAN|0.57||0.54|TWO_SIDED|95.0|-0.77|1.46||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables and age and age-squared as continuous covariates.||hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.||1.46|-0.77|0.54
71691839|NCT00357877|142898640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.51|STANDARD_ERROR_OF_MEAN|0.38||0.18|TWO_SIDED|95.0|-1.25|0.23||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|treatment and site included as class variables and age and age-squared as continuous covariates.||Hypothesized lower increment in active arm, though hypothesis testing was two-sided.||0.23|-1.25|0.18
71691840|NCT00357877|142898641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68|STANDARD_DEVIATION|0.57||0.24|TWO_SIDED|95.0|-1.8|0.45||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables, and age and age-squared as continuous covariates.||Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.||0.45|-1.80|0.24
71691841|NCT03570047|142898665|OTHER||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.558|0.766|||Cox proportional hazards model|||||0.766|0.558|<0.0001
71691842|NCT03570047|142898665|OTHER||Hazard Ratio (HR)|0.79||||0.0291|TWO_SIDED|95.0|0.642|0.977|||Cox proportional hazards model|||||0.977|0.642|0.0291
71691843|NCT03570047|142898665|OTHER||Hazard Ratio (HR)|0.71||||0.0001|TWO_SIDED|95.0|0.592|0.842|||Cox proportional hazards model|||||0.842|0.592|0.0001
71691844|NCT03570047|142898665|OTHER||Hazard Ratio (HR)|0.72||||0.0012|TWO_SIDED|95.0|0.591|0.879|||Cox proportional hazards model|||||0.879|0.591|0.0012
71691845|NCT03570047|142898666|OTHER||Hazard Ratio (HR)|0.72|||<|0.0001|TWO_SIDED|95.0|0.614|0.843|||Cox proportional hazards model|||||0.843|0.614|<0.0001
71691846|NCT03570047|142898666|OTHER||Hazard Ratio (HR)|0.66||||0.0003|TWO_SIDED|95.0|0.529|0.825|||Cox proportional hazards model|||||0.825|0.529|0.0003
71691847|NCT03570047|142898666|OTHER||Hazard Ratio (HR)|0.74||||0.0007|TWO_SIDED|95.0|0.618|0.879|||Cox proportional hazards model|||||0.879|0.618|0.0007
71691848|NCT03570047|142898666|OTHER||Hazard Ratio (HR)|0.71||||0.0011|TWO_SIDED|95.0|0.583|0.874|||Cox proportional hazards model|||||0.874|0.583|0.0011
71691849|NCT03570047|142898667|OTHER||Hazard Ratio (HR)|0.93||||0.0127|TWO_SIDED|95.0|0.872|0.984|||Cox proportional hazards model|||||0.984|0.872|0.0127
71691850|NCT03570047|142898667|OTHER||Hazard Ratio (HR)|0.96||||0.2893||95.0|0.881|1.039|||Cox proportional hazards model|||||1.039|0.881|0.2893
71691851|NCT03570047|142898667|OTHER||Hazard Ratio (HR)|0.94||||0.064|TWO_SIDED|95.0|0.881|1.004|||Cox proportional hazards model|||||1.004|0.881|0.0640
71691852|NCT03570047|142898667|OTHER||Hazard Ratio (HR)|1.03||||0.4404|TWO_SIDED|95.0|0.958|1.103|||Cox proportional hazards model|||||1.103|0.958|0.4404
71691853|NCT02820870|142898704|SUPERIORITY||Odds Ratio (OR)|3.0|||<|0.01|TWO_SIDED|95.0|1.84|4.9|||Regression, Logistic|With clustering by provider and team.||||4.9|1.84|<0.01
71691854|NCT02820870|142898705|SUPERIORITY||Odds Ratio (OR)|1.65||||0.06|TWO_SIDED|95.0|0.99|2.77|||Regression, Logistic|With cluster by provider and team.||||2.77|0.99|0.06
71935889|NCT01360632|143392548|SUPERIORITY_OR_OTHER||Ratio of response rate|1.33||||0.0122|TWO_SIDED|95.0|1.06|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.||1.66|1.06|0.0122
71935890|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.5836|TWO_SIDED|95.0|0.6|2.49|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.49|0.60|0.5836
71935891|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.31||||0.3792|TWO_SIDED|95.0|0.73|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.37|0.73|0.3792
71935892|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.77||||0.0101|TWO_SIDED|95.0|1.14|2.74|||Ratio of response rate|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.74|1.14|0.0101
71935893|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.75||||0.0065|TWO_SIDED|95.0|1.17|2.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.63|1.17|0.0065
71935894|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.41||||0.0526|TWO_SIDED|95.0|1.0|1.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.99|1.00|0.0526
71935895|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.51||||0.0156|TWO_SIDED|95.0|1.08|2.11|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.11|1.08|0.0156
71935896|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.22||||0.1689|TWO_SIDED|95.0|0.92|1.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.63|0.92|0.1689
71935897|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.37||||0.0231|TWO_SIDED|95.0|1.04|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.80|1.04|0.0231
71935898|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.4||||0.0175|TWO_SIDED|95.0|1.06|1.84|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.84|1.06|0.0175
71935899|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.59||||0.0004|TWO_SIDED|95.0|1.22|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||2.07|1.22|0.0004
71935900|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.21||||0.1396|TWO_SIDED|95.0|0.94|1.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.55|0.94|0.1396
71691855|NCT02754518|142898708|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71935901|NCT01360632|143392549|SUPERIORITY_OR_OTHER||Ratio of response rate|1.46||||0.0016|TWO_SIDED|95.0|1.15|1.86|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.||1.86|1.15|0.0016
71935902|NCT02173301|143392550|SUPERIORITY|||||||0.066|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.066
71935903|NCT02173301|143392550|SUPERIORITY|||||||0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||0.001
71935904|NCT02173301|143392550|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Restricted Maximum Likelihood (REML) - an REML-based mixed model for repeated measures (MMRM) with and with baseline PASI score as covariate||||||<0.001
71935905|NCT02173301|143392551|SUPERIORITY|||||||0.501|||||||Regression, Logistic|||Week 12 comparison||||0.501
71935906|NCT02173301|143392551|SUPERIORITY|||||||0.34|||||||Regression, Logistic|||Week 12 comparison||||0.340
71935907|NCT02173301|143392551|SUPERIORITY|||||||0.075|||||||Regression, Logistic|||Week 12 comparison||||0.075
71935908|NCT02173301|143392552|SUPERIORITY|||||||0.229|||||||Regression, Logistic|||Week 12 comparison||||0.229
71935909|NCT02173301|143392552|SUPERIORITY|||||||0.604|||||||Regression, Logistic|||Week 12 comparison||||0.604
71935910|NCT02173301|143392552|SUPERIORITY|||||||0.573|||||||Regression, Logistic|||Week 12 comparison||||0.573
71935911|NCT02884206|143392616|NON_INFERIORITY|To demonstrate non-inferiority that LCZ696 does not lead to a relevant decrease in cognition compared to valsartan at year 3, the lower bound of 95% CI does not include the pre-specified non-inferiority (NI) boundary (Cohen's D) of -0.3. An effect size of 0.3 in Cohen's D is generally considered as small.|LSM|-0.018||||0.7363|TWO_SIDED|95.0|-0.123|0.087|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0277, 95% CI: -0.1101 to 0.0778|0.0870|-0.1230|0.7363
71691856|NCT02754518|142898709|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71691857|NCT02754518|142898710|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71691858|NCT02754518|142898711|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71935912|NCT02884206|143392617|NON_INFERIORITY|To show that the point estimate of SUVr difference in mean change over 3 years is in favor of LCZ696 and the non-inferiority is demonstrated, with the upper bound of the 95% CI excluding the NI boundary of 0.01.|Least Squares Mean|-0.0292||||0.0579|TWO_SIDED|95.0|-0.0593|0.001|||ANCOVA|||Multiple Imputation ANCOVA in Global cortical composite||0.0010|-0.0593|0.0579
71691859|NCT02754518|142898712|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71935913|NCT02884206|143392618|SUPERIORITY||Least Squares Mean|0.0007||||0.9916|TWO_SIDED|95.0|-0.1339|0.1353|||ANCOVA|||Repeated measure ANCOVA for memory domain|Cohen's D: 0.0009; 95% CI: -0.0912 to 0.0922|0.1353|-0.1339|0.9916
71935914|NCT02884206|143392618|SUPERIORITY||Least Squares Mean|0.0327||||0.6348|TWO_SIDED|95.0|-0.1024|0.1677|||ANCOVA|||Repeated measure ANCOVA for executive function domain|Cohen's D: 0.0391, 95% CI: -0.0727 to 0.1192|0.1677|-0.1024|0.6348
71935915|NCT02884206|143392618|SUPERIORITY||Least Squares Mean|-0.1042||||0.2403|TWO_SIDED|95.0|-0.2783|0.07|||ANCOVA|||Repeated measure ANCOVA for attention domain|Cohen's D: -0.0967, 95% CI: -0.1542 to 0.0387|0.0700|-0.2783|0.2403
71935916|NCT02884206|143392619|SUPERIORITY||Least Squares Mean|-0.1105||||0.7081|TWO_SIDED|95.0|-0.6906|0.4696|||ANCOVA|||Repeated measure ANCOVA|Cohen's D: -0.0308, 95% CI: -0.1208 to 0.0820|0.4696|-0.6906|0.7081
71935917|NCT05117099|143392649|SUPERIORITY|||||||0.548|||||||ANOVA|||||||.548
71691860|NCT02754518|142898713|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71935918|NCT05117099|143392651|SUPERIORITY|||||||0.915|||||||ANOVA|||||||.915
71935919|NCT05117099|143392652|SUPERIORITY|||||||0.663|||||||ANOVA|||||||.663
71935920|NCT05117099|143392653|SUPERIORITY|||||||0.138|||||||ANOVA|||||||.138
71935921|NCT05117099|143392654|SUPERIORITY|||||||0.114|||||||ANOVA|||||||.114
71935922|NCT05117099|143392655|SUPERIORITY|||||||0.065|||||||ANOVA|||||||.065
71935923|NCT05117099|143392656|SUPERIORITY|||||||0.394|||||||ANOVA|||||||.394
71935924|NCT05117099|143392657|SUPERIORITY|||||||0.388|||||||ANOVA|||||||.388
71935925|NCT05117099|143392658|SUPERIORITY|||||||0.332|||||||ANOVA|||||||.332
71935926|NCT00125931|143392678|SUPERIORITY_OR_OTHER|||||||0.01|ONE_SIDED|95.0|||||ANOVA|||comparison of mean scores at hour 2 vs 3||||0.01
71935927|NCT00125931|143392679|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 1 sided|||comparison of mean score on treatment vs post-treatment days||||0.01
71935928|NCT00125931|143392679|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||t-test, 1 sided|||comparison of mean scores at pre-treatment vs treatment days||||0.4
71935929|NCT03654898|143392702|SUPERIORITY||cross-tabulation|0.48||||0.49|TWO_SIDED||||||Chi-squared|||||||0.49
71935930|NCT03654898|143392702|SUPERIORITY||Odds Ratio (OR)|1.06||||0.67|TWO_SIDED|95.0|0.8|1.42|||Regression, Logistic|Adjusted logistic regression||||1.42|0.80|0.67
71935931|NCT03654898|143392703|SUPERIORITY||Cross-tabulation|0.71||||0.4|TWO_SIDED||||||Chi-squared|||||||0.40
71935932|NCT03654898|143392704|SUPERIORITY||Cross-tabulation|0.5||||0.78|TWO_SIDED||||||Chi-squared|||Test 1 was for TFVdp while test 2 was for 3TCtp.||||0.78
71935933|NCT03654898|143392704|SUPERIORITY||Cross-tabulation|2.13||||0.34|TWO_SIDED||||||Chi-squared|||Test 2 was for 3TCtp while test 1 was for TFVdp.||||0.34
71935934|NCT01504867|143392766|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wald|This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.||The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%||||0.53
71935935|NCT01504867|143392767|SUPERIORITY_OR_OTHER||||||>|0.99|||||||Chi-squared|||||||>0.99
71935936|NCT01504867|143392768|SUPERIORITY_OR_OTHER|||||||0.36|||||||Chi-squared|||||||0.36
71935937|NCT01504867|143392769|SUPERIORITY_OR_OTHER|||||||0.23|||||||Chi-squared|||||||0.23
71935938|NCT01504867|143392770|SUPERIORITY_OR_OTHER|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||||||0.72
71935939|NCT01504867|143392771|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71935940|NCT01504867|143392772|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71935941|NCT01154153|143392781|SUPERIORITY_OR_OTHER||Treatment Ratio of Geometric mean|0.966|||||TWO_SIDED|95.0|0.892|1.045|||ANCOVA||The treatment ratio was calculated as an exponential of the mean difference between treatments in log scale.|Missing cortisol values were imputed with multiple imputation. AUC(0-24 hr) was calculated for each imputation and analyzed with log-transformation using an ANCOVA model and analyzed with treatment, sex, and age group as fixed effects, and log-transformed baseline value as a covariate. The mean difference in log scale between treatments and its standard error were calculated by Least Squares mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE.||1.045|0.892|
71935942|NCT01154153|143392782|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.85|STANDARD_ERROR_OF_MEAN|0.24||0.0007|TWO_SIDED|95.0|-1.34|-0.37|||ANCOVA|For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.||||-0.37|-1.34|0.0007
71935943|NCT01154153|143392783|SUPERIORITY_OR_OTHER|||||||0.1332||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.1332
71935944|NCT01154153|143392784|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel|||||||0.3314
71935945|NCT00210626|143392787|SUPERIORITY_OR_OTHER|||||||0.3807||95.0|||||ANCOVA|Covariate used is Baseline SF-36 PF Score. Baseline SF-36 PF Score was collected prior to the start of Procrit or Placebo treatment||The null hypothesis is that there is no difference between Procrit and Placebo in average SF-36 Physical Function Scores||||0.3807
71935946|NCT00210626|143392788|SUPERIORITY_OR_OTHER|||||||0.7038||95.0|||||Chi-squared|||||||0.7038
71935947|NCT02473510|143392789|SUPERIORITY_OR_OTHER||Rate Difference|0.4|||||TWO_SIDED|95.0|-5.2|2.6||||||||2.6|-5.2|
71935948|NCT02473510|143392790|SUPERIORITY_OR_OTHER||Rate Difference|16.7|||||TWO_SIDED|95.0|3.6|27.6||||||Up to Day 8||27.6|3.6|
71935949|NCT02473510|143392790|SUPERIORITY_OR_OTHER||Rate Difference|17.9|||||TWO_SIDED|95.0|4.4|29.3||||||Up to Day 15||29.3|4.4|
71935950|NCT01086215|143392818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71935951|NCT01086215|143392818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71935952|NCT01086215|143392818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71935953|NCT01086215|143392818|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion \>0||||||<0.0001
71935954|NCT00408876|143392821|SUPERIORITY_OR_OTHER|||||||0.503||95.0|||||Repeated Measures|||||||0.503
71935955|NCT00408876|143392821|SUPERIORITY_OR_OTHER|||||||0.447||95.0|||||Repeated Measures|||||||0.447
71935956|NCT00408876|143392821|SUPERIORITY_OR_OTHER|||||||0.084||95.0|||||Repeated Measures|||||||0.084
71935957|NCT00408876|143392821|SUPERIORITY_OR_OTHER|||||||0.964||95.0|||||Repeated Measures|||||||0.964
71935958|NCT00408876|143392821|SUPERIORITY_OR_OTHER|||||||0.451||95.0|||||Repeated Measures|||||||0.451
71935959|NCT00408876|143392821|SUPERIORITY_OR_OTHER|||||||0.333||95.0|||||Repeated Measures|||||||0.333
71935960|NCT00408876|143392822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.318||95.0|-0.62|0.2|||t-test, 2 sided|||||0.20|-0.62|0.318
71935961|NCT00408876|143392822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.005||95.0|-0.83|-0.15|||t-test, 2 sided|||||-0.15|-0.83|0.005
71935962|NCT00408876|143392822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.27||||0.124||95.0|-0.61|0.07|||t-test, 2 sided|||||0.07|-0.61|0.124
71935963|NCT00408876|143392822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.183||95.0|-0.7|0.13|||t-test, 2 sided|||||0.13|-0.70|0.183
71935964|NCT00408876|143392822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.778||95.0|-0.48|0.36|||t-test, 2 sided|||||0.36|-0.48|0.778
71935965|NCT00408876|143392822|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.22||||0.21||95.0|-0.13|0.57|||t-test, 2 sided|||||0.57|-0.13|0.210
71935966|NCT00408876|143392823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.161||95.0|-2.32|0.39|||t-test, 2 sided|||||0.39|-2.32|0.161
71935967|NCT00408876|143392823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.41||||0.019||95.0|-2.59|-0.24|||t-test, 2 sided|||||-0.24|-2.59|0.019
71935968|NCT00408876|143392823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.56||||0.01||95.0|-2.74|-0.38|||t-test, 2 sided|||||-0.38|-2.74|0.010
71935969|NCT00408876|143392823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.45||||0.526||95.0|-1.83|0.94|||t-test, 2 sided|||||0.94|-1.83|0.526
71935970|NCT00408876|143392823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.59||||0.397||95.0|-1.96|0.78|||t-test, 2 sided|||||0.78|-1.96|0.397
71935971|NCT00408876|143392823|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.813||95.0|-1.35|1.06|||t-test, 2 sided|||||1.06|-1.35|0.813
71935972|NCT00408876|143392824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.657||95.0|-0.5|0.79|||t-test, 2 sided|||||0.79|-0.50|0.657
71935973|NCT00408876|143392824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.384||95.0|-0.76|0.29|||t-test, 2 sided|||||0.29|-0.76|0.384
71691861|NCT02754518|142898714|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71935974|NCT00408876|143392824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.04||95.0|-1.1|-0.03|||t-test, 2 sided|||||-0.03|-1.10|0.040
71935975|NCT00408876|143392824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.38||||0.253||95.0|-1.03|0.27|||t-test, 2 sided|||||0.27|-1.03|0.253
71935976|NCT00408876|143392824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.034||95.0|-1.36|-0.05|||t-test, 2 sided|||||-0.05|-1.36|0.034
71935977|NCT00408876|143392824|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.33||||0.232||95.0|-0.86|0.21|||t-test, 2 sided|||||0.21|-0.86|0.232
71935978|NCT00408876|143392825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.365||95.0|-0.39|1.05|||t-test, 2 sided|||||1.05|-0.39|0.365
71935979|NCT00408876|143392825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.232||95.0|-0.95|0.23|||t-test, 2 sided|||||0.23|-0.95|0.232
71935980|NCT00408876|143392825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.314||95.0|-0.9|0.29|||t-test, 2 sided|||||0.29|-0.90|0.314
71935981|NCT00408876|143392825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.69||||0.062||95.0|-1.41|0.03|||t-test, 2 sided|||||0.03|-1.41|0.062
71935982|NCT00408876|143392825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.64||||0.083||95.0|-1.36|0.08|||t-test, 2 sided|||||0.08|-1.36|0.083
71935983|NCT00408876|143392825|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.859||95.0|-0.54|0.65|||t-test, 2 sided|||||0.65|-0.54|0.859
71935984|NCT00408876|143392826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.984||95.0|-0.34|0.34|||t-test, 2 sided|||||0.34|-0.34|0.984
71935985|NCT00408876|143392826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.41||||0.004||95.0|-0.7|-0.13|||t-test, 2 sided|||||-0.13|-0.70|0.004
71935986|NCT00408876|143392826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.81|-0.24|||t-test, 2 sided|||||-0.24|-0.81|<0.001
71935987|NCT00408876|143392826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.018||95.0|-0.76|-0.07|||t-test, 2 sided|||||-0.07|-0.76|0.018
71935988|NCT00408876|143392826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.003||95.0|-0.87|-0.19|||t-test, 2 sided|||||-0.19|-0.87|0.003
71935989|NCT00408876|143392826|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.442||95.0|-0.4|0.17|||t-test, 2 sided|||||0.17|-0.40|0.442
71935990|NCT00408876|143392827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.31||||0.464||95.0|-0.52|1.14|||t-test, 2 sided|||||1.14|-0.52|0.464
71935991|NCT00408876|143392827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.36|0.0|||t-test, 2 sided|||||0.00|-1.36|0.052
71935992|NCT00408876|143392827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.68||||0.052||95.0|-1.37|0.01|||t-test, 2 sided|||||0.01|-1.37|0.052
71935993|NCT00408876|143392827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.021||95.0|-1.83|-0.15|||t-test, 2 sided|||||-0.15|-1.83|0.021
71935994|NCT00408876|143392827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99||||0.02||95.0|-1.83|-0.16|||t-test, 2 sided|||||-0.16|-1.83|0.020
71935995|NCT00408876|143392827|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.988||95.0|-0.7|0.69|||t-test, 2 sided|||||0.69|-0.70|0.988
71935996|NCT00408876|143392828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.21||||0.543||95.0|-0.46|0.88|||t-test, 2 sided|||||0.88|-0.46|0.543
71935997|NCT00408876|143392828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.053||95.0|-1.1|0.01|||t-test, 2 sided|||||0.01|-1.10|0.053
71935998|NCT00408876|143392828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.65||||0.024||95.0|-1.21|-0.09|||t-test, 2 sided|||||-0.09|-1.21|0.024
71935999|NCT00408876|143392828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75||||0.03||95.0|-1.43|-0.07|||t-test, 2 sided|||||-0.07|-1.43|0.030
71936000|NCT00408876|143392828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.014||95.0|-1.54|-0.17|||t-test, 2 sided|||||-0.17|-1.54|0.014
71936001|NCT00408876|143392828|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.727||95.0|-0.66|0.46|||t-test, 2 sided|||||0.46|-0.66|0.727
71936002|NCT00408876|143392829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.813||95.0|-0.63|0.8|||t-test, 2 sided|||||0.80|-0.63|0.813
71936003|NCT00408876|143392829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.63||||0.035||95.0|-1.21|-0.04|||t-test, 2 sided|||||-0.04|-1.21|0.035
71936004|NCT00408876|143392829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.58||||0.054||95.0|-1.17|0.01|||t-test, 2 sided|||||0.01|-1.17|0.054
71936005|NCT00408876|143392829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.71||||0.051||95.0|-1.43|0.0|||t-test, 2 sided|||||0.00|-1.43|0.051
71936006|NCT00408876|143392829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.67||||0.07||95.0|-1.39|0.05|||t-test, 2 sided|||||0.05|-1.39|0.070
71936007|NCT00408876|143392829|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.872||95.0|-0.54|0.64|||t-test, 2 sided|||||0.64|-0.54|0.872
71936008|NCT00408876|143392830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.79||95.0|-0.68|0.89|||t-test, 2 sided|||||0.89|-0.68|0.790
71936009|NCT00408876|143392830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93||||0.005||95.0|-1.57|-0.28|||t-test, 2 sided|||||-0.28|-1.57|0.005
71936010|NCT00408876|143392830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87||||0.009||95.0|-1.52|-0.22|||t-test, 2 sided|||||-0.22|-1.52|0.009
71936011|NCT00408876|143392830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.03||||0.011||95.0|-1.83|-0.24|||t-test, 2 sided|||||-0.24|-1.83|0.011
71936012|NCT00408876|143392830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.97||||0.016||95.0|-1.77|-0.18|||t-test, 2 sided|||||-0.18|-1.77|0.016
71936013|NCT00408876|143392830|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.857||95.0|-0.6|0.72|||t-test, 2 sided|||||0.72|-0.60|0.857
71936014|NCT00408876|143392831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.03||||0.948||95.0|-0.81|0.76|||t-test, 2 sided|||||0.76|-0.81|0.948
71936015|NCT00408876|143392831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.55||||0.096||95.0|-1.2|0.1|||t-test, 2 sided|||||0.10|-1.20|0.096
71936016|NCT00408876|143392831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.239||95.0|-1.05|0.26|||t-test, 2 sided|||||0.26|-1.05|0.239
71936017|NCT00408876|143392831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.196||95.0|-1.32|0.27|||t-test, 2 sided|||||0.27|-1.32|0.196
71936018|NCT00408876|143392831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.37||||0.367||95.0|-1.17|0.43|||t-test, 2 sided|||||0.43|-1.17|0.367
71691862|NCT02754518|142898715|OTHER|||||||0.13||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.|paired t-test|||0.13
71936019|NCT00408876|143392831|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.637||95.0|-0.5|0.82|||t-test, 2 sided|||||0.82|-0.50|0.637
71936020|NCT00408876|143392832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.887||95.0|-0.76|0.65|||t-test, 2 sided|||||0.65|-0.76|0.887
71936021|NCT00408876|143392832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.006||95.0|-1.4|-0.23|||t-test, 2 sided|||||-0.23|-1.40|0.006
71936022|NCT00408876|143392832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.26||||0.392||95.0|-0.84|0.33|||t-test, 2 sided|||||0.33|-0.84|0.392
71936023|NCT00408876|143392832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.76||||0.036||95.0|-1.48|-0.05|||t-test, 2 sided|||||-0.05|-1.48|0.036
71936024|NCT00408876|143392832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.573||95.0|-0.92|0.51|||t-test, 2 sided|||||0.51|-0.92|0.573
71691863|NCT02754518|142898716|OTHER|||||||0.95||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.95
71936025|NCT00408876|143392832|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.064||95.0|-0.03|1.15|||t-test, 2 sided|||||1.15|-0.03|0.064
71936026|NCT00408876|143392833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.374||95.0|-1.15|0.43|||t-test, 2 sided|||||0.43|-1.15|0.374
71936027|NCT00408876|143392833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9||||0.007||95.0|-1.55|-0.25|||t-test, 2 sided|||||-0.25|-1.55|0.007
71936028|NCT00408876|143392833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.169||95.0|-1.12|0.2|||t-test, 2 sided|||||0.20|-1.12|0.169
71936029|NCT00408876|143392833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.182||95.0|-1.35|0.26|||t-test, 2 sided|||||0.26|-1.35|0.182
71936030|NCT00408876|143392833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.802||95.0|-0.91|0.7|||t-test, 2 sided|||||0.70|-0.91|0.802
71936031|NCT00408876|143392833|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.191||95.0|-0.22|1.11|||t-test, 2 sided|||||1.11|-0.22|0.191
71936032|NCT00408876|143392834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.25||||0.556||95.0|-1.1|0.59|||t-test, 2 sided|||||0.59|-1.10|0.556
71936033|NCT00408876|143392834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.041||95.0|-1.42|-0.03|||t-test, 2 sided|||||-0.03|-1.42|0.041
71936034|NCT00408876|143392834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.44||||0.22||95.0|-1.14|0.26|||t-test, 2 sided|||||0.26|-1.14|0.220
71936035|NCT00408876|143392834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.47||||0.278||95.0|-1.33|0.38|||t-test, 2 sided|||||0.38|-1.33|0.278
71936036|NCT00408876|143392834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.673||95.0|-1.04|0.68|||t-test, 2 sided|||||0.68|-1.04|0.673
71936037|NCT00408876|143392834|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.29||||0.422||95.0|-0.42|1.0|||t-test, 2 sided|||||1.00|-0.42|0.422
71936038|NCT00408876|143392835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.39||||0.234||95.0|-1.03|0.25|||t-test, 2 sided|||||0.25|-1.03|0.234
71936039|NCT00408876|143392835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.93|||<|0.001||95.0|-1.46|-0.4|||t-test, 2 sided|||||-0.40|-1.46|<0.001
71936040|NCT00408876|143392835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.34||||0.213||95.0|-0.87|0.2|||t-test, 2 sided|||||0.20|-0.87|0.213
71936041|NCT00408876|143392835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.105||95.0|-1.19|0.11|||t-test, 2 sided|||||0.11|-1.19|0.105
71936042|NCT00408876|143392835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.876||95.0|-0.6|0.7|||t-test, 2 sided|||||0.70|-0.60|0.876
71936043|NCT00408876|143392835|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.59||||0.033||95.0|0.05|1.13|||t-test, 2 sided|||||1.13|0.05|0.033
71936044|NCT00408876|143392836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.925||95.0|-0.73|0.8|||t-test, 2 sided|||||0.80|-0.73|0.925
71936045|NCT00408876|143392836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.85||||0.008||95.0|-1.49|-0.22|||t-test, 2 sided|||||-0.22|-1.49|0.008
71936046|NCT00408876|143392836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.49||||0.132||95.0|-1.12|0.15|||t-test, 2 sided|||||0.15|-1.12|0.132
71936047|NCT00408876|143392836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.024||95.0|-1.67|-0.12|||t-test, 2 sided|||||-0.12|-1.67|0.024
71936048|NCT00408876|143392836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.184||95.0|-1.3|0.25|||t-test, 2 sided|||||0.25|-1.30|0.184
71936049|NCT00408876|143392836|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37||||0.262||95.0|-0.27|1.01|||t-test, 2 sided|||||1.01|-0.27|0.262
71936050|NCT00408876|143392837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.07||||0.849||95.0|-0.84|0.69|||t-test, 2 sided|||||0.69|-0.84|0.849
71936051|NCT00408876|143392837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.73||||0.024||95.0|-1.36|-0.1|||t-test, 2 sided|||||-0.10|-1.36|0.024
71936052|NCT00408876|143392837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.09||||0.773||95.0|-0.73|0.54|||t-test, 2 sided|||||0.54|-0.73|0.773
71936053|NCT00408876|143392837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.66||||0.097||95.0|-1.43|0.12|||t-test, 2 sided|||||0.12|-1.43|0.097
71936054|NCT00408876|143392837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.96||95.0|-0.79|0.75|||t-test, 2 sided|||||0.75|-0.79|0.960
71936055|NCT00408876|143392837|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.64||||0.052||95.0|0.0|1.28|||t-test, 2 sided|||||1.28|0.00|0.052
71936056|NCT00408876|143392838|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
71936057|NCT00408876|143392838|SUPERIORITY_OR_OTHER|||||||0.507||95.0|||||Repeated Measures|||||||0.507
71936058|NCT00408876|143392838|SUPERIORITY_OR_OTHER|||||||0.056||95.0|||||Repeated Measures|||||||0.056
71936059|NCT00408876|143392838|SUPERIORITY_OR_OTHER|||||||0.816||95.0|||||Repeated Measures|||||||0.816
71936060|NCT00408876|143392838|SUPERIORITY_OR_OTHER|||||||0.208||95.0|||||Repeated Measures|||||||0.208
71936061|NCT00408876|143392838|SUPERIORITY_OR_OTHER|||||||0.212||95.0|||||Repeated Measures|||||||0.212
71936062|NCT00408876|143392839|SUPERIORITY_OR_OTHER|||||||0.885||95.0|||||Repeated Measures|||||||0.885
71936063|NCT00408876|143392839|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
71936064|NCT00408876|143392839|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
71936065|NCT00408876|143392839|SUPERIORITY_OR_OTHER|||||||0.095||95.0|||||Repeated Measures|||||||0.095
71936066|NCT00408876|143392839|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Repeated Measures|||||||0.040
71936067|NCT00408876|143392839|SUPERIORITY_OR_OTHER|||||||0.635||95.0|||||Repeated Measures|||||||0.635
71936068|NCT00408876|143392840|SUPERIORITY_OR_OTHER|||||||0.575||95.0|||||Repeated Measures|||||||0.575
71936069|NCT00408876|143392840|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Repeated Measures|||||||0.009
71936070|NCT00408876|143392840|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71936071|NCT00408876|143392840|SUPERIORITY_OR_OTHER|||||||0.115||95.0|||||Repeated Measures|||||||0.115
71936072|NCT00408876|143392840|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
71936073|NCT00408876|143392840|SUPERIORITY_OR_OTHER|||||||0.072||95.0|||||Repeated Measures|||||||0.072
71936074|NCT00408876|143392841|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||Repeated Measures|||||||0.516
71936075|NCT00408876|143392841|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
71936076|NCT00408876|143392841|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71936077|NCT00408876|143392841|SUPERIORITY_OR_OTHER|||||||0.112||95.0|||||Repeated Measures|||||||0.112
71936078|NCT00408876|143392841|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Repeated Measures|||||||0.010
71936079|NCT00408876|143392841|SUPERIORITY_OR_OTHER|||||||0.219||95.0|||||Repeated Measures|||||||0.219
71936080|NCT00408876|143392842|SUPERIORITY_OR_OTHER|||||||0.309||95.0|||||Repeated Measures|||||||0.309
71936081|NCT00408876|143392842|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
71936082|NCT00408876|143392842|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71936083|NCT00408876|143392842|SUPERIORITY_OR_OTHER|||||||0.116||95.0|||||Repeated Measures|||||||0.116
71936084|NCT00408876|143392842|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Repeated Measures|||||||0.033
71936085|NCT00408876|143392842|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||Repeated Measures|||||||0.480
71936086|NCT00408876|143392843|SUPERIORITY_OR_OTHER|||||||0.709||95.0|||||Repeated Measures|||||||0.709
71936087|NCT00408876|143392843|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Repeated Measures|||||||0.012
71936088|NCT00408876|143392843|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Repeated Measures|||||||0.001
71936089|NCT00408876|143392843|SUPERIORITY_OR_OTHER|||||||0.097||95.0|||||Repeated Measures|||||||0.097
71936090|NCT00408876|143392843|SUPERIORITY_OR_OTHER|||||||0.023||95.0|||||Repeated Measures|||||||0.023
71936091|NCT00408876|143392843|SUPERIORITY_OR_OTHER|||||||0.435||95.0|||||Repeated Measures|||||||0.435
71936092|NCT00408876|143392844|SUPERIORITY_OR_OTHER|||||||0.931||95.0|||||Repeated Measures|||||||0.931
71936093|NCT00408876|143392844|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
71936094|NCT00408876|143392844|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71936095|NCT00408876|143392844|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
71936096|NCT00408876|143392844|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||Repeated Measures|||||||0.007
71691864|NCT02754518|142898717|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71936097|NCT00408876|143392844|SUPERIORITY_OR_OTHER|||||||0.416||95.0|||||Repeated Measures|||||||0.416
71936098|NCT00408876|143392845|SUPERIORITY_OR_OTHER|||||||0.634||95.0|||||Repeated Measures|||||||0.634
71936099|NCT00408876|143392845|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||Repeated Measures|||||||0.031
71936100|NCT00408876|143392845|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Repeated Measures|||||||0.002
71936101|NCT00408876|143392845|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
71936102|NCT00408876|143392845|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Repeated Measures|||||||0.003
71936103|NCT00408876|143392845|SUPERIORITY_OR_OTHER|||||||0.313||95.0|||||Repeated Measures|||||||0.313
71936104|NCT00408876|143392846|SUPERIORITY_OR_OTHER|||||||0.91||95.0|||||Repeated Measures|||||||0.910
71936105|NCT00408876|143392846|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||Repeated Measures|||||||0.026
71936106|NCT00408876|143392846|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71936107|NCT00408876|143392846|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||Repeated Measures|||||||0.090
71936108|NCT00408876|143392846|SUPERIORITY_OR_OTHER|||||||0.006||95.0|||||Repeated Measures|||||||0.006
71936109|NCT00408876|143392846|SUPERIORITY_OR_OTHER|||||||0.171||95.0|||||Repeated Measures|||||||0.171
71936110|NCT00408876|143392847|SUPERIORITY_OR_OTHER|||||||0.733||95.0|||||Repeated Measures|||||||0.733
71936111|NCT00408876|143392847|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||Repeated Measures|||||||0.022
71936112|NCT00408876|143392847|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Repeated Measures|||||||<0.001
71936113|NCT00408876|143392847|SUPERIORITY_OR_OTHER|||||||0.128||95.0|||||Repeated Measures|||||||0.128
71936114|NCT00408876|143392847|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||Repeated Measures|||||||0.013
71936115|NCT00408876|143392847|SUPERIORITY_OR_OTHER|||||||0.225||95.0|||||Repeated Measures|||||||0.225
71936116|NCT00408876|143392848|SUPERIORITY_OR_OTHER|||||||0.89||95.0|||||Repeated Measures|||||||0.890
71936117|NCT00408876|143392848|SUPERIORITY_OR_OTHER|||||||0.079||95.0|||||Repeated Measures|||||||0.079
71936118|NCT00408876|143392848|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Repeated Measures|||||||0.035
71936119|NCT00408876|143392848|SUPERIORITY_OR_OTHER|||||||0.117||95.0|||||Repeated Measures|||||||0.117
71936120|NCT00408876|143392848|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||Repeated Measures|||||||0.060
71936121|NCT00408876|143392848|SUPERIORITY_OR_OTHER|||||||0.647||95.0|||||Repeated Measures|||||||0.647
71936122|NCT00408876|143392849|SUPERIORITY_OR_OTHER|||||||0.243||95.0|||||Repeated Measures|||||||0.243
71936123|NCT00408876|143392849|SUPERIORITY_OR_OTHER|||||||0.11||95.0|||||Repeated Measures|||||||0.110
71936124|NCT00408876|143392849|SUPERIORITY_OR_OTHER|||||||0.236||95.0|||||Repeated Measures|||||||0.236
71936125|NCT00408876|143392849|SUPERIORITY_OR_OTHER|||||||0.014||95.0|||||Repeated Measures|||||||0.014
71936126|NCT00408876|143392849|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Repeated Measures|||||||0.036
71936127|NCT00408876|143392849|SUPERIORITY_OR_OTHER|||||||0.756||95.0|||||Repeated Measures|||||||0.756
71936128|NCT00408876|143392850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.23||||0.465||95.0|-0.84|0.39|||t-test, 2 sided|||||0.39|-0.84|0.465
71936129|NCT00408876|143392850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.79||||0.002||95.0|-1.3|-0.29|||t-test, 2 sided|||||-0.29|-1.30|0.002
71936130|NCT00408876|143392850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.31||||0.233||95.0|-0.82|0.2|||t-test, 2 sided|||||0.20|-0.82|0.233
71936131|NCT00408876|143392850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.56||||0.075||95.0|-1.19|0.06|||t-test, 2 sided|||||0.06|-1.19|0.075
71936132|NCT00408876|143392850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.798||95.0|-0.71|0.54|||t-test, 2 sided|||||0.54|-0.71|0.798
71936133|NCT00408876|143392850|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.48||||0.066||95.0|-0.03|1.0|||t-test, 2 sided|||||1.00|-0.03|0.066
71936134|NCT00408876|143392851|SUPERIORITY_OR_OTHER|||||||0.869||95.0|||||Fisher Exact|||||||0.869
71936135|NCT00408876|143392851|SUPERIORITY_OR_OTHER|||||||0.141||95.0|||||Fisher Exact|||||||0.141
71936136|NCT00408876|143392851|SUPERIORITY_OR_OTHER|||||||0.033||95.0|||||Fisher Exact|||||||0.033
71936137|NCT00408876|143392851|SUPERIORITY_OR_OTHER|||||||0.142||95.0|||||Fisher Exact|||||||0.142
71936138|NCT00408876|143392851|SUPERIORITY_OR_OTHER|||||||0.049||95.0|||||Fisher Exact|||||||0.049
71936139|NCT00408876|143392851|SUPERIORITY_OR_OTHER|||||||0.587||95.0|||||Fisher Exact|||||||0.587
71936140|NCT00408876|143392852|SUPERIORITY_OR_OTHER|||||||0.356||95.0|||||Fisher Exact|||||||0.356
71936141|NCT00408876|143392852|SUPERIORITY_OR_OTHER|||||||0.472||95.0|||||Fisher Exact|||||||0.472
71936142|NCT00408876|143392852|SUPERIORITY_OR_OTHER|||||||0.255||95.0|||||Fisher Exact|||||||0.255
71936143|NCT00408876|143392852|SUPERIORITY_OR_OTHER|||||||0.107||95.0|||||Fisher Exact|||||||0.107
71936144|NCT00408876|143392852|SUPERIORITY_OR_OTHER|||||||0.053||95.0|||||Fisher Exact|||||||0.053
71936145|NCT00408876|143392852|SUPERIORITY_OR_OTHER|||||||0.779||95.0|||||Fisher Exact|||||||0.779
71691865|NCT02754518|142898718|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71936146|NCT00408876|143392853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.21||||0.747||95.0|-1.47|1.06|||t-test, 2 sided|||||1.06|-1.47|0.747
71936147|NCT00408876|143392853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.07||||0.045||95.0|-2.12|-0.02|||t-test, 2 sided|||||-0.02|-2.12|0.045
71936148|NCT00408876|143392853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.58||95.0|-0.76|1.36|||t-test, 2 sided|||||1.36|-0.76|0.580
71936149|NCT00408876|143392853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.86||||0.185||95.0|-2.14|0.41|||t-test, 2 sided|||||0.41|-2.14|0.185
71936150|NCT00408876|143392853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.51||||0.438||95.0|-0.77|1.79|||t-test, 2 sided|||||1.79|-0.77|0.438
71936151|NCT00408876|143392853|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.37||||0.012||95.0|0.3|2.44|||t-test, 2 sided|||||2.44|0.30|0.012
71936152|NCT00408876|143392854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.46||||0.729||95.0|-2.16|3.08|||t-test, 2 sided|||||3.08|-2.16|0.729
71936153|NCT00408876|143392854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.02||||0.352||95.0|-1.14|3.18|||t-test, 2 sided|||||3.18|-1.14|0.352
71936154|NCT00408876|143392854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.81||||0.465||95.0|-3.0|1.37|||t-test, 2 sided|||||1.37|-3.00|0.465
71936155|NCT00408876|143392854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.677||95.0|-2.09|3.21|||t-test, 2 sided|||||3.21|-2.09|0.677
71936156|NCT00408876|143392854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.27||||0.345||95.0|-3.92|1.38|||t-test, 2 sided|||||1.38|-3.92|0.345
71936157|NCT00408876|143392854|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.84||||0.102||95.0|-4.04|0.37|||t-test, 2 sided|||||0.37|-4.04|0.102
71936158|NCT00408876|143392855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.977||95.0|-2.91|2.83|||t-test, 2 sided|||||2.83|-2.91|0.977
71936159|NCT00408876|143392855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.451||95.0|-1.44|3.24|||t-test, 2 sided|||||3.24|-1.44|0.451
71936160|NCT00408876|143392855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.74||||0.15||95.0|-0.63|4.11|||t-test, 2 sided|||||4.11|-0.63|0.150
71936161|NCT00408876|143392855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.94||||0.524||95.0|-1.96|3.83|||t-test, 2 sided|||||3.83|-1.96|0.524
71936162|NCT00408876|143392855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.78||||0.23||95.0|-1.13|4.69|||t-test, 2 sided|||||4.69|-1.13|0.230
71936163|NCT00408876|143392855|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.84||||0.491||95.0|-1.55|3.23|||t-test, 2 sided|||||3.23|-1.55|0.491
71936164|NCT00408876|143392856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.15||||0.645||95.0|-0.49|0.79|||t-test, 2 sided|||||0.79|-0.49|0.645
71936165|NCT00408876|143392856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.027||95.0|0.07|1.12|||t-test, 2 sided|||||1.12|0.07|0.027
71936166|NCT00408876|143392856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.006||95.0|0.22|1.29|||t-test, 2 sided|||||1.29|0.22|0.006
71936167|NCT00408876|143392856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.44||||0.18||95.0|-0.21|1.1|||t-test, 2 sided|||||1.10|-0.21|0.180
71936168|NCT00408876|143392856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.069||95.0|-0.05|1.25|||t-test, 2 sided|||||1.25|-0.05|0.069
71936169|NCT00408876|143392856|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.564||95.0|-0.38|0.7|||t-test, 2 sided|||||0.70|-0.38|0.564
71936170|NCT00408876|143392857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.929||95.0|-0.92|1.0|||t-test, 2 sided|||||1.00|-0.92|0.929
71936171|NCT00408876|143392857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58||||0.147||95.0|-0.21|1.36|||t-test, 2 sided|||||1.36|-0.21|0.147
71936172|NCT00408876|143392857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.16||||0.7||95.0|-0.64|0.95|||t-test, 2 sided|||||0.95|-0.64|0.700
71936173|NCT00408876|143392857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.54||||0.279||95.0|-0.44|1.51|||t-test, 2 sided|||||1.51|-0.44|0.279
71936174|NCT00408876|143392857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.822||95.0|-0.86|1.09|||t-test, 2 sided|||||1.09|-0.86|0.822
71936175|NCT00408876|143392857|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.299||95.0|-1.22|0.38|||t-test, 2 sided|||||0.38|-1.22|0.299
71936176|NCT00408876|143392858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.18||||0.766||95.0|-1.33|0.98|||t-test, 2 sided|||||0.98|-1.33|0.766
71936177|NCT00408876|143392858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6||||0.217||95.0|-0.35|1.55|||t-test, 2 sided|||||1.55|-0.35|0.217
71936178|NCT00408876|143392858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.07||||0.88||95.0|-0.89|1.04|||t-test, 2 sided|||||1.04|-0.89|0.880
71936179|NCT00408876|143392858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.78||||0.193||95.0|-0.39|1.94|||t-test, 2 sided|||||1.94|-0.39|0.193
71936180|NCT00408876|143392858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.25||||0.675||95.0|-0.92|1.42|||t-test, 2 sided|||||1.42|-0.92|0.675
71936181|NCT00408876|143392858|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.53||||0.288||95.0|-1.5|0.45|||t-test, 2 sided|||||0.45|-1.50|0.288
71936182|NCT00408876|143392859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.42||||0.501||95.0|-1.66|0.81|||t-test, 2 sided|||||0.81|-1.66|0.501
71936183|NCT00408876|143392859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.33||||0.524||95.0|-0.69|1.35|||t-test, 2 sided|||||1.35|-0.69|0.524
71936184|NCT00408876|143392859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.89||||0.089||95.0|-0.14|1.91|||t-test, 2 sided|||||1.91|-0.14|0.089
71691866|NCT02754518|142898719|OTHER|||||||0.65||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired T-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.65
71936185|NCT00408876|143392859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.75||||0.234||95.0|-0.49|2.0|||t-test, 2 sided|||||2.00|-0.49|0.234
71936186|NCT00408876|143392859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.31||||0.04||95.0|0.06|2.56|||t-test, 2 sided|||||2.56|0.06|0.040
71936187|NCT00408876|143392859|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.56||||0.289||95.0|-0.48|1.59|||t-test, 2 sided|||||1.59|-0.48|0.289
71936188|NCT00408876|143392860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.862||95.0|-0.27|0.32|||t-test, 2 sided|||||0.32|-0.27|0.862
71936189|NCT00408876|143392860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.11||||0.368||95.0|-0.13|0.35|||t-test, 2 sided|||||0.35|-0.13|0.368
71936190|NCT00408876|143392860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.628||95.0|-0.18|0.31|||t-test, 2 sided|||||0.31|-0.18|0.628
71936191|NCT00408876|143392860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.09||||0.573||95.0|-0.21|0.38|||t-test, 2 sided|||||0.38|-0.21|0.573
71936192|NCT00408876|143392860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.819||95.0|-0.26|0.33|||t-test, 2 sided|||||0.33|-0.26|0.819
71936193|NCT00408876|143392860|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.05||||0.687||95.0|-0.3|0.2|||t-test, 2 sided|||||0.20|-0.30|0.687
71936194|NCT00408876|143392861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.972||95.0|-0.48|0.5|||t-test, 2 sided|||||0.50|-0.48|0.972
71936195|NCT00408876|143392861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.99||95.0|-0.4|0.4|||t-test, 2 sided|||||0.40|-0.40|0.990
71936196|NCT00408876|143392861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.793||95.0|-0.35|0.46|||t-test, 2 sided|||||0.46|-0.35|0.793
71936197|NCT00408876|143392861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.981||95.0|-0.5|0.49|||t-test, 2 sided|||||0.49|-0.50|0.981
71936198|NCT00408876|143392861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.857||95.0|-0.45|0.54|||t-test, 2 sided|||||0.54|-0.45|0.857
71936199|NCT00408876|143392861|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.805||95.0|-0.36|0.46|||t-test, 2 sided|||||0.46|-0.36|0.805
71936200|NCT00408876|143392862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.34||95.0|-0.26|0.75|||t-test, 2 sided|||||0.75|-0.26|0.340
71936201|NCT00408876|143392862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.848||95.0|-0.45|0.37|||t-test, 2 sided|||||0.37|-0.45|0.848
71936202|NCT00408876|143392862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.573||95.0|-0.54|0.3|||t-test, 2 sided|||||0.30|-0.54|0.573
71936203|NCT00408876|143392862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29||||0.272||95.0|-0.79|0.22|||t-test, 2 sided|||||0.22|-0.79|0.272
71936204|NCT00408876|143392862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.161||95.0|-0.88|0.15|||t-test, 2 sided|||||0.15|-0.88|0.161
71936205|NCT00408876|143392862|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.08||||0.711||95.0|-0.5|0.34|||t-test, 2 sided|||||0.34|-0.50|0.711
71936206|NCT00408876|143392863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.713||95.0|-1.39|0.95|||t-test, 2 sided|||||0.95|-1.39|0.713
71936207|NCT00408876|143392863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52||||0.288||95.0|-0.44|1.49|||t-test, 2 sided|||||1.49|-0.44|0.288
71936208|NCT00408876|143392863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.351||95.0|-1.44|0.51|||t-test, 2 sided|||||0.51|-1.44|0.351
71936209|NCT00408876|143392863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.74||||0.219||95.0|-0.44|1.93|||t-test, 2 sided|||||1.93|-0.44|0.219
71936210|NCT00408876|143392863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.24||||0.686||95.0|-1.43|0.94|||t-test, 2 sided|||||0.94|-1.43|0.686
71936211|NCT00408876|143392863|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.98||||0.05||95.0|-1.97|0.0|||t-test, 2 sided|||||0.00|-1.97|0.050
71936212|NCT00408876|143392864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.663||95.0|-0.06|0.04|||t-test, 2 sided|||||0.04|-0.06|0.663
71936213|NCT00408876|143392864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.33||95.0|-0.02|0.06|||t-test, 2 sided|||||0.06|-0.02|0.330
71936214|NCT00408876|143392864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.143||95.0|-0.01|0.07|||t-test, 2 sided|||||0.07|-0.01|0.143
71936215|NCT00408876|143392864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.218||95.0|-0.02|0.08|||t-test, 2 sided|||||0.08|-0.02|0.218
71936216|NCT00408876|143392864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.04||||0.1||95.0|-0.01|0.09|||t-test, 2 sided|||||0.09|-0.01|0.100
71936217|NCT00408876|143392864|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.614||95.0|-0.03|0.05|||t-test, 2 sided|||||0.05|-0.03|0.614
71936218|NCT00408876|143392865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.786||95.0|-1.83|1.39|||t-test, 2 sided|||||1.39|-1.83|0.786
71936219|NCT00408876|143392865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.445||95.0|-1.85|0.81|||t-test, 2 sided|||||0.81|-1.85|0.445
71936220|NCT00408876|143392865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.39||||0.043||95.0|0.04|2.74|||t-test, 2 sided|||||2.74|0.04|0.043
71936221|NCT00408876|143392865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.721||95.0|-1.92|1.33|||t-test, 2 sided|||||1.33|-1.92|0.721
71691867|NCT02754518|142898720|OTHER|||||||0.06||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||0.06
71691868|NCT02754518|142898721|OTHER|||||||0.76||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.76
71936222|NCT00408876|143392865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.053||95.0|-0.02|3.24|||t-test, 2 sided|||||3.24|-0.02|0.053
71936223|NCT00408876|143392865|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.91||||0.006||95.0|0.54|3.27|||t-test, 2 sided|||||3.27|0.54|0.006
71936224|NCT00408876|143392866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.39||||0.378||95.0|-0.48|1.25|||t-test, 2 sided|||||1.25|-0.48|0.378
71936225|NCT00408876|143392866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.13||||0.723||95.0|-0.84|0.59|||t-test, 2 sided|||||0.59|-0.84|0.723
71936226|NCT00408876|143392866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.542||95.0|-0.95|0.5|||t-test, 2 sided|||||0.50|-0.95|0.542
71936227|NCT00408876|143392866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.52||||0.245||95.0|-1.39|0.36|||t-test, 2 sided|||||0.36|-1.39|0.245
71691869|NCT02754518|142898722|OTHER|||||||0.07||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Fisher Exact|||Primary outcome was presented at baseline and 1-year as frequency and percentages based upon the Shapiro-Wilks test of normality, and then analyzed with the Fisher exact test.||||0.07
71691870|NCT02754518|142898723|OTHER|||||||0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.001
71691871|NCT02754518|142898726|OTHER|||||||0.03||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.03
71691872|NCT02754518|142898727|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71936228|NCT00408876|143392866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.61||||0.169||95.0|-1.48|0.26|||t-test, 2 sided|||||0.26|-1.48|0.169
71936229|NCT00408876|143392866|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.796||95.0|-0.82|0.63|||t-test, 2 sided|||||0.63|-0.82|0.796
71936230|NCT00408876|143392868|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71936231|NCT00408876|143392868|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71936232|NCT00408876|143392868|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71936233|NCT00408876|143392869|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
71936234|NCT00408876|143392870|SUPERIORITY_OR_OTHER|||||||0.048||95.0|||||t-test, 2 sided|||||||0.048
71936235|NCT00408876|143392871|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||t-test, 2 sided|||||||0.015
71936236|NCT00408876|143392871|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||t-test, 2 sided|||||||0.046
71936237|NCT00408876|143392872|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||t-test, 2 sided|||||||0.039
71936238|NCT00408876|143392873|SUPERIORITY_OR_OTHER|||||||0.042||95.0|||||t-test, 2 sided|||||||0.042
71936239|NCT00408876|143392874|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71936240|NCT00408876|143392875|SUPERIORITY_OR_OTHER|||||||0.031||95.0|||||t-test, 2 sided|||||||0.031
71936241|NCT00408876|143392876|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||t-test, 2 sided|||||||0.030
71936242|NCT00408876|143392877|SUPERIORITY_OR_OTHER|||||||0.005||95.0|||||t-test, 2 sided|||||||0.005
71936243|NCT00408876|143392877|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||||||<0.001
71936244|NCT00408876|143392877|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71936245|NCT00408876|143392878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.38||||0.348||95.0|-4.28|1.51|||t-test, 2 sided|||||1.51|-4.28|0.348
71936246|NCT00408876|143392878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.5||||0.04||95.0|0.11|4.89|||t-test, 2 sided|||||4.89|0.11|0.040
71936247|NCT00408876|143392878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.61||||0.191||95.0|-0.81|4.03|||t-test, 2 sided|||||4.03|-0.81|0.191
71936248|NCT00408876|143392878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.89||||0.009||95.0|0.97|6.8|||t-test, 2 sided|||||6.80|0.97|0.009
71936249|NCT00408876|143392878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.0||||0.044||95.0|0.08|5.91|||t-test, 2 sided|||||5.91|0.08|0.044
71936250|NCT00408876|143392878|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.89||||0.473||95.0|-3.33|1.55|||t-test, 2 sided|||||1.55|-3.33|0.473
71936251|NCT00408876|143392879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.846||95.0|-3.61|4.4|||t-test, 2 sided|||||4.40|-3.61|0.846
71936252|NCT00408876|143392879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.14||||0.934||95.0|-3.45|3.17|||t-test, 2 sided|||||3.17|-3.45|0.934
71936253|NCT00408876|143392879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.03||||0.234||95.0|-1.32|5.39|||t-test, 2 sided|||||5.39|-1.32|0.234
71936254|NCT00408876|143392879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.54||||0.794||95.0|-4.58|3.5|||t-test, 2 sided|||||3.50|-4.58|0.794
71936255|NCT00408876|143392879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.64||||0.426||95.0|-2.4|5.67|||t-test, 2 sided|||||5.67|-2.40|0.426
71936256|NCT00408876|143392879|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.17||||0.207||95.0|-1.21|5.55|||t-test, 2 sided|||||5.55|-1.21|0.207
71936257|NCT00408876|143392880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.17||||0.901||95.0|-2.54|2.89|||t-test, 2 sided|||||2.89|-2.54|0.901
71936258|NCT00408876|143392880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11||||0.926||95.0|-2.35|2.14|||t-test, 2 sided|||||2.14|-2.35|0.926
71936259|NCT00408876|143392880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.62||||0.002||95.0|1.35|5.9|||t-test, 2 sided|||||5.90|1.35|0.002
71936260|NCT00408876|143392880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.28||||0.841||95.0|-3.02|2.46|||t-test, 2 sided|||||2.46|-3.02|0.841
71936261|NCT00408876|143392880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.45||||0.014||95.0|0.71|6.19|||t-test, 2 sided|||||6.19|0.71|0.014
71936262|NCT00408876|143392880|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.73||||0.001||95.0|1.44|6.02|||t-test, 2 sided|||||6.02|1.44|0.001
71936263|NCT00408876|143392881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.057||95.0|-1.41|0.02|||t-test, 2 sided|||||0.02|-1.41|0.057
71936264|NCT00408876|143392881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.46||||0.128||95.0|-1.05|0.13|||t-test, 2 sided|||||0.13|-1.05|0.128
71936265|NCT00408876|143392881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.82||||0.007||95.0|-1.42|-0.22|||t-test, 2 sided|||||-0.22|-1.42|0.007
71936266|NCT00408876|143392881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.24||||0.518||95.0|-0.48|0.96|||t-test, 2 sided|||||0.96|-0.48|0.518
71936267|NCT00408876|143392881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12||||0.734||95.0|-0.85|0.6|||t-test, 2 sided|||||0.60|-0.85|0.734
71936268|NCT00408876|143392881|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.36||||0.239||95.0|-0.97|0.24|||t-test, 2 sided|||||0.24|-0.97|0.239
71936269|NCT01488019|143392925|NON_INFERIORITY|The hazard ratio and 90% two-sided confidence interval for the hazard ratio comparing Perforomist to placebo were estimated. Non-inferiority was declared if the upper limit of the two-sided 90% confidence interval was wholly less than 1.5.|Hazard Ratio (HR)|0.965|||||TWO_SIDED|90.0|0.711|1.308||Hazard Ratio was calculated as Perforomist vs Placebo. The non-inferiority margin for the hazard ratio is 1.5. Subjects with no primary event at withdrawal or study completion were treated as censored observations at time of withdrawal|Regression, Cox|Treatment, site group, and bronchodilator reversibility included as covariates in the model.|Hazard Ratio was calculated as Perforomist Inhalation Solution vs Placebo. The non-inferiority margin for the hazard ratio is 1.5.|||1.308|0.711|
71936270|NCT02400710|143392939|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||ANOVA|||||||.05
71936271|NCT02400710|143392940|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED||||||Chi-squared|||||||.05
71936272|NCT04147715|143392951|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9913|||||TWO_SIDED|90.0|0.9232|1.0645|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by analysis of variance (ANOVA) fit with a linear mixed effect model with the natural log (ln)-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% confidence interval (CI) between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0645|0.9232|
71936273|NCT04147715|143392951|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9754|||||TWO_SIDED|90.0|0.8916|1.0671|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed by an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as fixed effect, and participant as random effect. The difference and 90% CI between the ln-transformed Cmax of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0671|0.8916|
71936274|NCT04147715|143392953|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0353|||||TWO_SIDED|90.0|0.9421|1.1377|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1377|0.9421|
71936275|NCT04147715|143392953|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9096|||||TWO_SIDED|90.0|0.8791|0.9411|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||0.9411|0.8791|
71936276|NCT04147715|143392954|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0071|||||TWO_SIDED|90.0|0.9679|1.0479|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0479|0.9679|
71936277|NCT04147715|143392954|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of S-648414 were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9852|||||TWO_SIDED|90.0|0.9605|1.0105|||||Ratio = S-648414 + Dolutegravir / S-648414|The effect of dolutegravir on the PK of S-648414 was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of S-648414 + dolutegravir and S-648414 alone were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0105|0.9605|
71936278|NCT04147715|143392956|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1806|||||TWO_SIDED|90.0|1.1171|1.2477|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2477|1.1171|
71936279|NCT04147715|143392956|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.048|||||TWO_SIDED|90.0|0.9656|1.1373|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1373|0.9656|
71936280|NCT04147715|143392958|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.3445|||||TWO_SIDED|90.0|1.2352|1.4636|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.4636|1.2352|
71936281|NCT04147715|143392958|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0769|||||TWO_SIDED|90.0|1.0137|1.1441|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed Cτ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cτ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1441|1.0137|
71936282|NCT04147715|143392959|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.1939|||||TWO_SIDED|90.0|1.1176|1.2754|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.2754|1.1176|
71936283|NCT04147715|143392959|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, Cτ, and AUC0-τ of dolutegravir were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0482|||||TWO_SIDED|90.0|0.9881|1.1119|||||Ratio = S-648414 + Dolutegravir / Dolutegravir|The effect of S-648414 on the plasma PK of dolutegravir was assessed using an ANOVA fitted with a linear mixed effect model with the natural log-transformed AUC0-τ as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-τ of dolutegravir plus S-648414 and dolutegravir alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.1119|0.9881|
71936284|NCT04147715|143392961|OTHER||Slope|0.9857|||||TWO_SIDED|95.0|0.9341|1.0373||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(Cmax) = Intercept + Slope × ln(Dose) + Random error||1.0373|0.9341|
71936285|NCT04147715|143392961|OTHER||Geometric Least Squares Mean Ratio|0.8786|||||TWO_SIDED|90.0|0.7705|1.0019|||||Ratio = Fed / Fasted|"The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed state and fasted state using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as random effect.~The difference and 90% CI between the fed and fasted state ln-transformed Cmax were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.0019|0.7705|
71936286|NCT04147715|143392963|OTHER||Slope|1.0252|||||TWO_SIDED|95.0|0.984|1.0665||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-last) = Intercept + Slope × ln(Dose) + Random error||1.0665|0.9840|
71936287|NCT04147715|143392963|OTHER||Geometric Least Squares Mean Ratio|0.9598|||||TWO_SIDED|90.0|0.8585|1.073|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-last were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0730|0.8585|
71936288|NCT04147715|143392964|OTHER||Slope|1.028|||||TWO_SIDED|95.0|0.9866|1.0695||||||The dose proportionality of plasma PK parameters of S-648414 was examined for all fasted groups in Part 1 using the power model. The power model assumes a linear relationship between the ln-transformed parameter and ln-transformed dose where ln(AUC0-inf) = Intercept + Slope × ln(Dose) + Random error||1.0695|0.9866|
71936289|NCT04147715|143392964|OTHER||Geometric Least Squares Mean Ratio|0.9646|||||TWO_SIDED|90.0|0.8643|1.0766|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed AUC0-inf were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0766|0.8643|
71936290|NCT04147715|143392965|OTHER||Geometric Least Squares Mean Ratio|1.0272|||||TWO_SIDED|90.0|0.9949|1.0606|||||Ratio = Fed / Fasted|The effect of food on the plasma PK of S-648414 was examined after a single dose of 100 mg S-648414 in the fed and fasted state using an ANOVA fitted with a linear mixed effect model, with ln-transformed t1/2,z as the dependent variable, treatment as a fixed effect, and participant as random effect. The difference and 90% CI between the fed and fasted state ln-transformed t1/2,z were estimated, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI.||1.0606|0.9949|
71936291|NCT04147715|143392972|OTHER||Geometric Least Squares Mean Ratio|1.5167|||||TWO_SIDED|90.0|1.2654|1.818|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8180|1.2654|
71936292|NCT04147715|143392972|OTHER||Geometric Least Squares Mean Ratio|1.8372|||||TWO_SIDED|90.0|1.5696|2.1506|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 Cmax after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed Cmax, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed Cmax, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1506|1.5696|
71936293|NCT04147715|143392972|OTHER||Geometric Least Squares Mean Ratio|1.7489|||||TWO_SIDED|90.0|1.525|2.0057|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0057|1.5250|
71936294|NCT04147715|143392972|OTHER||Geometric Least Squares Mean Ratio|2.1453|||||TWO_SIDED|90.0|1.9741|2.3313|||||Ratio = Day 14 / Day 1|"The accumulation ratio of Cmax in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed Cmax, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed Cmax on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.3313|1.9741|
71936295|NCT04147715|143392974|OTHER||Geometric Least Squares Mean Ratio|1.6277|||||TWO_SIDED|90.0|1.4038|1.8874|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after a single dose of S-648414 (Day 1) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||1.8874|1.4038|
71936296|NCT04147715|143392974|OTHER||Geometric Least Squares Mean Ratio|1.7454|||||TWO_SIDED|90.0|1.4785|2.0605|||||Ratio = 50 mg / 30 mg|"The dose proportionality of plasma S-648414 AUC0-τ after multiple doses of S-648414 (Day 14) was assessed using an ANOVA model fitted to the ln-transformed AUC0-τ, with dose group fitted as a fixed factor.~The point estimates and 90% CIs were generated for the ratios of the 50 mg dose to 30 mg dose ln-transformed AUC0-τ, then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0605|1.4785|
71936297|NCT04147715|143392974|OTHER||Geometric Least Squares Mean Ratio|1.9102|||||TWO_SIDED|90.0|1.7788|2.0513|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 30 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.0513|1.7788|
71936298|NCT04147715|143392974|OTHER||Geometric Least Squares Mean Ratio|2.0478|||||TWO_SIDED|90.0|1.9203|2.1837|||||Ratio = Day 14 / Day 1|"The accumulation ratio of AUC0-τ in the 50 mg dose group was calculated as the ratio of Day 14 to Day 1 using an ANOVA fitted with a linear mixed model with ln-transformed AUC0-τ, Day as a fixed effect and participant as a random effect.~The difference and 90% CI between the ln-transformed AUC0-τ on Day 1 and Day 14 were estimated then back-transformed to obtain the corresponding geometric least squares mean ratio and 90% CI."||2.1837|1.9203|
71936299|NCT04147715|143392981|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.9241|||||TWO_SIDED|90.0|0.8057|1.06|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0600|0.8057|
71936300|NCT04147715|143392981|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|1.0303|||||TWO_SIDED|90.0|0.9299|1.1415|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed Cmax as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed Cmax of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.1415|0.9299|
71936301|NCT04147715|143392983|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500|Geometric Least Squares Mean Ratio|0.842|||||TWO_SIDED|90.0|0.6628|1.0696|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0696|0.6628|
71936302|NCT04147715|143392983|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8542|||||TWO_SIDED|90.0|0.7185|1.0155|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-last as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-last of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0155|0.7185|
71936303|NCT04147715|143392984|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8377|||||TWO_SIDED|90.0|0.6645|1.0561|||||Ratio = 30 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0561|0.6645|
71936304|NCT04147715|143392984|OTHER|The drug interaction was assessed by whether the 90% CIs for the geometric least squares mean ratio of Cmax, AUC0-last, and AUC0-inf of midazolam were completely contained within the range of 0.8000 to 1.2500.|Geometric Least Squares Mean Ratio|0.8529|||||TWO_SIDED|90.0|0.7213|1.0085|||||Ratio = 50 mg S-648414 + Midazolam / Midazolam|The effect of S-648414 on the PK of midazolam (a CYP3A substrate) was assessed using an ANOVA fitted with a linear mixed effect model with ln-transformed AUC0-inf as the dependent variable, treatment as a fixed effect, and participant as a random effect. The difference and 90% CI between the ln-transformed AUC0-inf of midazolam plus S-648414 and midazolam alone was estimated then back-transformed to obtain the corresponding geometric least squares mean ratios and 90% CIs.||1.0085|0.7213|
71936305|NCT03404206|143392998|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71936306|NCT03404206|143392998|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71936307|NCT03404206|143392999|SUPERIORITY||Least squares means|-34.73|||||TWO_SIDED|95.0|-45.67|-23.8|||ANCOVA|||||-23.8|-45.67|
71936308|NCT03404206|143392999|SUPERIORITY||Least squares means|-73.43|||||TWO_SIDED|95.0|-89.01|-57.85|||ANCOVA|||||-57.85|-89.01|
71936309|NCT03404206|143392999|SUPERIORITY||Least squares means|-38.7|||||TWO_SIDED|95.0|-54.29|-23.11|||ANCOVA|||||-23.11|-54.29|
71936310|NCT03404206|143393000|SUPERIORITY||Least squares means|-18.21|||||TWO_SIDED|95.0|-23.52|-12.89|||ANCOVA|||||-12.89|-23.52|
71936311|NCT03404206|143393000|SUPERIORITY||Least squares means|-33.72|||||TWO_SIDED|95.0|-41.29|-26.14|||ANCOVA|||||-26.14|-41.29|
71936312|NCT03404206|143393000|SUPERIORITY||Least squares means|-15.51|||||TWO_SIDED|95.0|-23.09|-7.93|||ANCOVA|||||-7.93|-23.09|
71936313|NCT02629965|143393022|SUPERIORITY||Mean Difference (Final Values)|0.115|STANDARD_ERROR_OF_MEAN|0.019|<|0.001|TWO_SIDED|95.0|0.077|0.153|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.153|0.077|<0.001
71936314|NCT02629965|143393023|SUPERIORITY||Mean Difference (Final Values)|4.168|STANDARD_ERROR_OF_MEAN|5.26||0.4291|TWO_SIDED|95.0|-6.211|14.548|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|14.548|-6.211|0.4291
71936315|NCT02629965|143393024|SUPERIORITY||Mean Difference (Final Values)|9.501|STANDARD_ERROR_OF_MEAN|83.704||0.9098|TWO_SIDED|95.0|-155.692|174.694|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|174.694|-155.692|0.9098
71936316|NCT02629965|143393025|SUPERIORITY||Mean Difference (Final Values)|-0.292|STANDARD_ERROR_OF_MEAN|0.469||0.5338|TWO_SIDED|95.0|-1.217|0.633|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.633|-1.217|0.5338
71936317|NCT02629965|143393026|SUPERIORITY||Mean Difference (Final Values)|0.939|STANDARD_ERROR_OF_MEAN|1.007||0.3524|TWO_SIDED|95.0|-1.048|2.926|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|2.926|-1.048|0.3524
71936318|NCT02629965|143393027|SUPERIORITY||Mean Difference (Final Values)|2.257|STANDARD_ERROR_OF_MEAN|2.647||0.3949|TWO_SIDED|95.0|-2.966|7.481|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|7.481|-2.966|0.3949
71936319|NCT02629965|143393028|SUPERIORITY||Mean Difference (Final Values)|2.42|STANDARD_ERROR_OF_MEAN|3.543||0.4955|TWO_SIDED|95.0|-4.572|9.411|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|9.411|-4.572|0.4955
71936320|NCT02629965|143393029|SUPERIORITY||Mean Difference (Final Values)|0.134|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|0.091|0.176|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.176|0.091|<0.0001
71936321|NCT02629965|143393030|SUPERIORITY||Mean Difference (Final Values)|0.105|STANDARD_ERROR_OF_MEAN|0.009|<|0.0001|TWO_SIDED|95.0|0.088|0.123|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.123|0.088|<0.0001
71936322|NCT02629965|143393031|SUPERIORITY||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001|TWO_SIDED|95.0|0.13|0.197|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.197|0.130|<0.0001
71936323|NCT02629965|143393032|SUPERIORITY||Mean Difference (Final Values)|0.133|STANDARD_ERROR_OF_MEAN|0.015|<|0.0001|TWO_SIDED|95.0|0.103|0.162|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.162|0.103|<0.0001
71936324|NCT02629965|143393033|SUPERIORITY||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.1|0.156|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.156|0.100|<0.0001
71936325|NCT02629965|143393034|SUPERIORITY||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001|TWO_SIDED|95.0|0.056|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.056|<0.0001
71936326|NCT02629965|143393035|SUPERIORITY||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.014|<|0.0001|TWO_SIDED|95.0|0.058|0.114|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.114|0.058|<0.0001
71936327|NCT02629965|143393036|SUPERIORITY||Mean Difference (Final Values)|0.083|STANDARD_ERROR_OF_MEAN|0.012|<|0.0001|TWO_SIDED|95.0|0.059|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.108|0.059|<0.0001
71936328|NCT02629965|143393037|SUPERIORITY||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|0.114|0.189|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.|0.189|0.114|<0.0001
71936329|NCT02330081|143393038|NON_INFERIORITY|The FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of platelet recovery must be ≥ 66% of fresh control platelet values|Risk Ratio (RR)|83.3|STANDARD_ERROR_OF_MEAN|4.97|||ONE_SIDED|95.0|76.2||||||Estimate is the ratio of the mean platelet recovery of treatment over control||||76.2|
71936330|NCT02330081|143393039|NON_INFERIORITY|One of the FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of the mean platelet survival time must be ≥58% of fresh control platelet mean survival time|Mean Ratio Survival Time|81.0|STANDARD_ERROR_OF_MEAN|2.0|||ONE_SIDED|95.0|77.0||||||Estimate is the ratio of the mean platelet survival time of treatment over control||||77.0|
71936331|NCT00905489|143393057|SUPERIORITY_OR_OTHER||Ratio NVP XR: NVP IR (%)|91.2|STANDARD_ERROR_OF_MEAN|1.05||0.008|TWO_SIDED|90.0|83.47|99.64|||Mixed Models Analysis|Adjusted geometric means are estimated from the mixed model for intra-individual comparison.||||99.64|83.47|0.0080
71936332|NCT00895583|143393097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.239|TWO_SIDED|95.0|0.4|1.3||Two-sided alpha equals (=) 0.05.|Fisher Exact|||||1.3|0.4|0.239
71936333|NCT00895583|143393098|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.422|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||||1.4|0.5|0.422
71936334|NCT00895583|143393099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.524|TWO_SIDED|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||Month 12||1.4|0.5|0.524
71936335|NCT00895583|143393099|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.298|TWO_SIDED|95.0|0.4|1.2||Alpha was unadjusted.|Fisher Exact|||Month 24||1.2|0.4|0.298
71936336|NCT00895583|143393100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.6||||0.055|TWO_SIDED|95.0|0.3|1.0||Alpha was unadjusted.|Fisher Exact|||Month 12||1.0|0.3|0.055
71936337|NCT00895583|143393100|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.33|TWO_SIDED|95.0|0.4|1.3||Alpha was unadjusted.|Fisher Exact|||Month 24||1.3|0.4|0.330
71936338|NCT00895583|143393101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.543|TWO_SIDED|95.0|0.4|1.5||Alpha was unadjusted.|Fisher Exact|||Month 12||1.5|0.4|0.543
71936339|NCT00895583|143393101|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||1|TWO_SIDED|95.0|0.6|1.8||Alpha was unadjusted.|Fisher Exact|||Month 24||1.8|0.6|1.000
71936340|NCT00895583|143393103|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.0|STANDARD_ERROR_OF_MEAN|1.3||0.019|TWO_SIDED|95.0|0.5|5.5||Alpha was unadjusted.|ANCOVA|Analysis of covariance (ANCOVA) with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 6||5.5|0.5|0.019
71936341|NCT00895583|143393103|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.5||0.215|TWO_SIDED|95.0|-4.8|1.1||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 12||1.1|-4.8|0.215
71936342|NCT00895583|143393103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.6|STANDARD_ERROR_OF_MEAN|1.7||0.722|TWO_SIDED|95.0|-2.7|3.9||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 18||3.9|-2.7|0.722
71936343|NCT00895583|143393103|SUPERIORITY_OR_OTHER||LS Mean Difference|0.7|STANDARD_ERROR_OF_MEAN|1.9||0.71|TWO_SIDED|95.0|-3.0|4.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 24||4.4|-3.0|0.710
71936344|NCT00895583|143393104|SUPERIORITY_OR_OTHER||Slope difference (SRL-TAC)|-1.8||||0.131|TWO_SIDED|95.0|-4.2|0.5|||Random coefficient model||Random coefficient model with GFR as the dependent variable and study day as the independent variable.|Slope difference (sirolimus \[SRL\] minus tacrolimus \[TAC\])||0.5|-4.2|0.131
71936345|NCT00895583|143393106|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|2.4||0.105|TWO_SIDED|95.0|-8.6|0.8||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 6||0.8|-8.6|0.105
71936346|NCT00895583|143393106|SUPERIORITY_OR_OTHER||LS Mean Difference|7.7|STANDARD_ERROR_OF_MEAN|3.3||0.023|TWO_SIDED|95.0|1.1|14.3||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 12||14.3|1.1|0.023
71936347|NCT00895583|143393106|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|3.4||0.955|TWO_SIDED|95.0|-6.8|6.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 18||6.4|-6.8|0.955
71936348|NCT00895583|143393106|SUPERIORITY_OR_OTHER||LS Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|5.8||0.582|TWO_SIDED|95.0|-8.2|14.6||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 24||14.6|-8.2|0.582
71936349|NCT00895583|143393107|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||||||0.006
71936350|NCT00895583|143393108|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 12 Post-transplantation||||1.000
71936351|NCT00895583|143393108|SUPERIORITY_OR_OTHER|||||||0.215|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 24 post-transplantation||||0.215
71936352|NCT00895583|143393109|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 6||||0.499
71936353|NCT00895583|143393109|SUPERIORITY_OR_OTHER|||||||0.067|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.067
71936354|NCT00895583|143393109|SUPERIORITY_OR_OTHER|||||||0.061|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 18||||0.061
71936355|NCT00895583|143393109|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||0.020
71936356|NCT00895583|143393112|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-therapy Period||||1.000
71936357|NCT00895583|143393112|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-therapy Period||||1.000
71936358|NCT00895583|143393113|SUPERIORITY_OR_OTHER|||||||0.284|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Baseline||||0.284
71936359|NCT00895583|143393113|SUPERIORITY_OR_OTHER|||||||0.046|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 12||||0.046
71936360|NCT00895583|143393113|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Month 24||||1.000
71936361|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.81|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 12||||<0.001
71691873|NCT02754518|142898728|OTHER|||||||0.02||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.02
71691874|NCT02754518|142898729|OTHER||||||<|0.001||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|t-test, 2 sided|Paired t-test||Primary outcome was presented at baseline and 1-year as means +/- standard deviations based upon the Shapiro-Wilks test of normality, and then analyzed with paired t-tests.||||<0.001
71691875|NCT02754518|142898730|OTHER|||||||0.82||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.82
71691876|NCT02754518|142898731|OTHER||||||<|0.001||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||<0.001
71691877|NCT02754518|142898732|OTHER|||||||0.01||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.01
71691878|NCT02754518|142898733|OTHER|||||||0.11||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.11
71691879|NCT02754518|142898734|OTHER|||||||0.17||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.17
71691880|NCT02754518|142898735|OTHER|||||||0.035||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.035
71936362|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Mean|0.61|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 24||||<0.001
71691881|NCT02754518|142898736|OTHER|||||||0.059||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.059
71691882|NCT02754518|142898737|OTHER|||||||0.054||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.054
71691883|NCT02754518|142898738|OTHER|||||||0.28||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.28
71691884|NCT02754518|142898739|OTHER|||||||0.002||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.002
71691885|NCT02754518|142898740|OTHER|||||||0.008||||||P-Values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.008
71691886|NCT02754518|142898741|OTHER|||||||0.005||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.005
71691887|NCT02754518|142898742|OTHER|||||||0.056||||||P-values are not adjusted for multiple comparisons. Tests were two-tailed, considered statistically significant with a p-value \<0.05, and conducted using STATA MP version 15 (College Station, TX).|Sign test|||Primary outcome was presented at baseline and 1-year as medians (interquartile range) based upon the Shapiro-Wilks test of normality, and then analyzed with Wilcoxon signed-rank test.||||0.056
71691888|NCT03318003|142898744|SUPERIORITY||Pearson Chi Square|0.76||||0.92|TWO_SIDED|||||no adjustments made|Chi-squared|||||||0.92
71691889|NCT02683239|142898854|SUPERIORITY||Least Squares Mean|-0.73|STANDARD_ERROR_OF_MEAN|0.221|=|0.001|TWO_SIDED|95.0|-1.159|-0.293|||Mixed Models Analysis|||||-0.293|-1.159|= 0.0010
71691890|NCT02683239|142898854|SUPERIORITY||Least Squares Mean|-1.22|STANDARD_ERROR_OF_MEAN|0.217|<|0.0001|TWO_SIDED|95.0|-1.646|-0.793|||Mixed Models Analysis|||||-0.793|-1.646|< 0.0001
71936363|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.01|STANDARD_ERROR_OF_MEAN|0.03||0.824|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 12||||0.824
71936364|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.02|STANDARD_ERROR_OF_MEAN|0.05||0.735|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 24||||0.735
71936365|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.49|STANDARD_ERROR_OF_MEAN|0.11|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 12||||<0.001
71936366|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.42|STANDARD_ERROR_OF_MEAN|0.13||0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 24||||0.001
71691891|NCT02683239|142898854|SUPERIORITY||Least Squares Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.664|-0.793|||Mixed Models Analysis|||||-0.793|-1.664|< 0.0001
71691892|NCT02683239|142898854|SUPERIORITY||Least Squares Mean|-1.04|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.477|-0.606|||Mixed Models Analysis|||||-0.606|-1.477|< 0.0001
71936367|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.65|STANDARD_ERROR_OF_MEAN|0.13|<|0.001|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 12||||<0.001
71936368|NCT00895583|143393114|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.37|STANDARD_ERROR_OF_MEAN|0.16||0.028|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 24||||0.028
71936369|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.429|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Baseline||||0.429
71936370|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 12||||0.326
71936371|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.517|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 24||||0.517
71936372|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agents (insulin), Baseline||||1.000
71691893|NCT02683239|142898855|SUPERIORITY||Least Squares Mean|-0.74|STANDARD_ERROR_OF_MEAN|0.218|=|0.0007|TWO_SIDED|95.0|-1.163|-0.309|||Mixed Models Analysis|||||-0.309|-1.163|= 0.0007
71691894|NCT02683239|142898855|SUPERIORITY||Least Squares Mean|-1.2|STANDARD_ERROR_OF_MEAN|0.218|<|0.0001|TWO_SIDED|95.0|-1.624|-0.768|||Mixed Models Analysis|||||-0.768|-1.624|< 0.0001
71691895|NCT02683239|142898855|SUPERIORITY||Least Squares Mean|-1.26|STANDARD_ERROR_OF_MEAN|0.223|<|0.0001|TWO_SIDED|95.0|-1.698|-0.822|||Mixed Models Analysis|||||-0.822|-1.698|< 0.0001
71691896|NCT02683239|142898855|SUPERIORITY||Least Squares Mean|-1.13|STANDARD_ERROR_OF_MEAN|0.222|<|0.0001|TWO_SIDED|95.0|-1.564|-0.695|||Mixed Models Analysis|||||-0.695|-1.564|< 0.0001
71691897|NCT02683239|142898856|SUPERIORITY||Least Squares Mean|-0.2|STANDARD_ERROR_OF_MEAN|0.09|=|0.023|TWO_SIDED|95.0|-0.38|-0.028|||Mixed Models Analysis|||||-0.028|-0.380|= 0.0230
71691898|NCT02683239|142898856|SUPERIORITY||Least Squares Mean|-0.27|STANDARD_ERROR_OF_MEAN|0.088|=|0.0025|TWO_SIDED|95.0|-0.437|-0.093|||Mixed Models Analysis|||||-0.093|-0.437|= 0.0025
71936373|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 12||||1.000
71691899|NCT02683239|142898856|SUPERIORITY||Least Squares Mean|-0.32|STANDARD_ERROR_OF_MEAN|0.09|=|0.0003|TWO_SIDED|95.0|-0.496|-0.145|||Mixed Models Analysis|||||-0.145|-0.496|= 0.0003
71691900|NCT02683239|142898856|SUPERIORITY||Least Squares Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.089|=|0.001|TWO_SIDED|95.0|-0.466|-0.118|||Mixed Models Analysis|||||-0.118|-0.466|= 0.0010
71691901|NCT00873730|142898862|SUPERIORITY_OR_OTHER|||||||0.6031|||||||Chi-squared|||||||0.6031
71691902|NCT00873730|142898863|SUPERIORITY_OR_OTHER|||||||0.9166|||||||Chi-squared|||||||0.9166
71936374|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.223|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 24||||0.223
71936375|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.498|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Baseline||||0.498
71691903|NCT00873730|142898864|SUPERIORITY_OR_OTHER|||||||0.7564|||||||Chi-squared|||||||0.7564
71691904|NCT00873730|142898865|SUPERIORITY_OR_OTHER|||||||0.3266|||||||Chi-squared|||||||0.3266
71691905|NCT00873730|142898866|SUPERIORITY_OR_OTHER|||||||0.7481|||||||Chi-squared|||||||0.7481
71691906|NCT00873730|142898867|SUPERIORITY_OR_OTHER|||||||0.7721|||||||Chi-squared|||||||0.7721
71691907|NCT00873730|142898868|SUPERIORITY_OR_OTHER|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Nocturnal Back Pain.||||0.6660
71691908|NCT00873730|142898868|SUPERIORITY_OR_OTHER|||||||0.5364|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Overall Spinal Pain.||||0.5364
71691909|NCT00873730|142898869|SUPERIORITY_OR_OTHER|||||||0.9426|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Physician Global Assessment.||||0.9426
71691910|NCT00873730|142898869|SUPERIORITY_OR_OTHER|||||||0.4969|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Patient Global Assessment.||||0.4969
71691911|NCT00873730|142898870|SUPERIORITY_OR_OTHER|||||||0.6687|||||||Wilcoxon (Mann-Whitney)|||||||0.6687
71691912|NCT00873730|142898871|SUPERIORITY_OR_OTHER|||||||0.6739|||||||Wilcoxon (Mann-Whitney)|||||||0.6739
71691913|NCT00873730|142898872|SUPERIORITY_OR_OTHER|||||||0.2772|||||||Wilcoxon (Mann-Whitney)|||||||0.2772
71691914|NCT00873730|142898873|SUPERIORITY_OR_OTHER|||||||0.156|||||||Wilcoxon (Mann-Whitney)|||||||0.1560
71691915|NCT00873730|142898874|SUPERIORITY_OR_OTHER|||||||0.2099|||||||Chi-squared|||Analysis provided for Mobility.||||0.2099
71691916|NCT00873730|142898874|SUPERIORITY_OR_OTHER|||||||0.8009|||||||Chi-squared|||Analysis provided for Self-care.||||0.8009
71691917|NCT00873730|142898874|SUPERIORITY_OR_OTHER|||||||0.429|||||||Chi-squared|||Analysis provided for Usual activities.||||0.4290
71691918|NCT00873730|142898874|SUPERIORITY_OR_OTHER|||||||0.0461|||||||Chi-squared|||Analysis provided for Pain/Discomfort.||||0.0461
71936376|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.566|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 12||||0.566
71936377|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.423|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 24||||0.423
71936378|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.033|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Baseline||||0.033
71936379|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 12||||0.900
71936380|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.802|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 24||||0.802
71936381|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Baseline||||0.260
71936382|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 12||||0.086
71691919|NCT00873730|142898874|SUPERIORITY_OR_OTHER|||||||0.562|||||||Chi-squared|||Analysis provided for Anxiety/Depression.||||0.5620
71691920|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.3476|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical functioning.||||0.3476
71691921|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.9045|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical role limitations.||||0.9045
71691922|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.8558|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Bodily pain.||||0.8558
71691923|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.3123|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for General health.||||0.3123
71691924|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.3327|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Vitality.||||0.3327
71691925|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.8334|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Social functioning.||||0.8334
71936383|NCT00895583|143393115|SUPERIORITY_OR_OTHER|||||||0.723|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 24||||0.723
71691926|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.7998|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Emotional role limitations.||||0.7998
71691927|NCT00873730|142898875|SUPERIORITY_OR_OTHER|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Mental health.||||0.7125
71691928|NCT00873730|142898877|SUPERIORITY_OR_OTHER|||||||0.7404|||||||Wilcoxon (Mann-Whitney)|||||||0.7404
71691929|NCT04878055|142898889|SUPERIORITY||Odds Ratio (OR)|1.626||||0.216|TWO_SIDED|95.0|0.752|3.514|||Two-sided regression, Logistic|||Analysis is based on logistic regression model with Multiple Imputation under missing not at random using retrieve dropouts with proportion of patients alive and free of respiratory failure at Day 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.||3.514|0.752|0.216
71691930|NCT04878055|142898890|SUPERIORITY|||||||0.377|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||||||0.377
71691931|NCT04878055|142898891|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Date 28 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables. Site is considered as random effects that vary randomly among patients.|Odds Ratio (OR)|0.468||||0.17|TWO_SIDED|95.0|0.158|1.386|||Two-sided regression, Logistic|||||1.386|0.158|0.17
71691932|NCT04878055|142898892|SUPERIORITY||Odds Ratio (OR)|0.561||||0.168|TWO_SIDED|95.0|0.247|1.277|||Regression, Logistic|||||1.277|0.247|0.168
71691933|NCT04878055|142898893|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. Estimates were calculated taking into account the following competing risks: Death, discontinuation for AEs and patient transferred to another institution.||||||0.167|||||||Gray's Test|||Until Day 28||||0.167
71691934|NCT04878055|142898894|SUPERIORITY|||||||0.55||||||Comparison between treatment arms is performed by means of a Fisher's Exact test.|Fisher Exact|||At Day 3 - please note that the number of subjects is 268 (180+88) and not 270.||||0.55
71691935|NCT04878055|142898894|SUPERIORITY|||||||0.128|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared mean.||At Day 7 - Please note that the total of subjects in this analysis is not 270 but 266 (n=179 in the Reparixin group and n=87 in the placebo group).||||0.128
71691936|NCT04878055|142898894|SUPERIORITY|||||||0.235|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 14 - Please note that the total of subjects in this analysis is not 270 but 256 (n=173 in the Reparixin group and n=83 in the placebo group).||||0.235
71691937|NCT04878055|142898894|SUPERIORITY|||||||0.281|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 21 - Please note that the total of subjects in this analysis is not 270 but 255 (n=172 in the Reparixin group and n=83 in the placebo group).||||0.281
71691938|NCT04878055|142898894|SUPERIORITY|||||||0.273|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test.||At Day 90 - Please note that the total of subjects in this analysis is not 270 but 50 (n=33 in the Reparixin group and n=17 in the placebo group).||||0.273
71691939|NCT04878055|142898895|SUPERIORITY|||||||0.047||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 3 - Please note that the number of subjects in this analysis is not 270 but 255||||0.047
71691940|NCT04878055|142898895|SUPERIORITY|||||||0.262|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.262
71691941|NCT04878055|142898895|SUPERIORITY|||||||0.367|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 14 - Please note that the number of subjects in this analysis is not 270 but 209||||0.367
71691942|NCT04878055|142898895|SUPERIORITY|||||||0.882||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Wilcoxon (Mann-Whitney)|||At Day 21 - Please note that the number of subjects in this analysis is not 270 but 176||||0.882
71691943|NCT04878055|142898895|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 28 - Please note that the number of subjects in this analysis is not 270 but 190||||0.19
71691944|NCT04878055|142898895|SUPERIORITY|||||||0.161||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||At Day 60 - Please note that the number of subjects in this analysis is not 270 but 201||||0.161
71936384|NCT00895583|143393116|SUPERIORITY_OR_OTHER||Treatment Ratio|1.71|||<|0.001|TWO_SIDED|95.0|1.38|2.11||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 12; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.11|1.38|<0.001
71691945|NCT04878055|142898895|SUPERIORITY|||||||0.853|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At Day 90 - Please note that the number of subjects in this analysis is not 270 but 18||||0.853
71936385|NCT00895583|143393116|SUPERIORITY_OR_OTHER||Treatment Ratio|1.77|||<|0.001|TWO_SIDED|95.0|1.39|2.26||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 24; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.||2.26|1.39|<0.001
71936386|NCT00895583|143393117|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Pre-randomization||||1.000
71936387|NCT00895583|143393117|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period||||0.020
71936388|NCT00895583|143393117|SUPERIORITY_OR_OTHER|||||||0.021|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period||||0.021
71936389|NCT00895583|143393118|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha is unadjusted.|Fisher Exact|||||||<0.001
71936390|NCT00895583|143393119|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period, any treatment||||<0.001
71936391|NCT00895583|143393119|SUPERIORITY_OR_OTHER|||||||0.685|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period, any treatment||||0.685
71936392|NCT00895583|143393120|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.0|STANDARD_ERROR_OF_MEAN|0.0||0.521|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.521
71936393|NCT00895583|143393121|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.25||0.265|TWO_SIDED|||||Alpha is unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.265
71936394|NCT00895583|143393122|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|10.02|STANDARD_ERROR_OF_MEAN|23.61||0.672|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.672
71936395|NCT00895583|143393123|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.45|STANDARD_ERROR_OF_MEAN|0.67||0.504|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.|||||0.504
71936396|NCT00895583|143393124|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.56|STANDARD_ERROR_OF_MEAN|1.18||0.637|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.637
71936397|NCT00895583|143393125|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|0.08|STANDARD_ERROR_OF_MEAN|1.48||0.955|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.955
71936398|NCT00895583|143393126|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|216.29|STANDARD_ERROR_OF_MEAN|198.84||0.279|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||||||0.279
71936399|NCT00895583|143393127|SUPERIORITY_OR_OTHER||Difference in Adjusted Means|-0.22|STANDARD_ERROR_OF_MEAN|0.23||0.337|TWO_SIDED|||||Alpha was unadjusted.|ANCOVA|||||||0.337
71936400|NCT00895583|143393128|SUPERIORITY_OR_OTHER|||||||0.025|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset (from baseline up to On-Therapy Month 24)||||0.025
71936401|NCT00895583|143393128|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 1 year (from baseline up to On-Therapy Month 12)||||0.012
71936402|NCT00895583|143393128|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||New onset at 2 years (from On-Therapy Month 12 to On-Therapy Month 24)||||1.000
71936403|NCT00895583|143393129|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (12-Month)||||1.000
71936404|NCT00895583|143393129|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (12-Month)||||1.000
71936405|NCT00895583|143393129|SUPERIORITY_OR_OTHER|||||||0.386|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (24-Month)||||0.386
71936406|NCT00895583|143393129|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|||||Alpha was unadjusted.|Fisher Exact|||Insulin (24-Month)||||1.000
71936407|NCT00895583|143393130|SUPERIORITY_OR_OTHER|||||||0.129|TWO_SIDED||||||Fisher Exact|||||||0.129
71936408|NCT00895583|143393131|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED||||||Fisher Exact|||||||1.000
71936409|NCT00895583|143393132|SUPERIORITY_OR_OTHER|||||||0.276|TWO_SIDED||||||Fisher Exact|||||||0.276
71691946|NCT04878055|142898895|SUPERIORITY|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At EOS - Please note that the number of subjects in this analysis is not 270 but 229||||0.068
71936410|NCT00895583|143393133|SUPERIORITY_OR_OTHER|||||||0.158|TWO_SIDED||||||Fisher Exact|||||||0.158
71936411|NCT01710306|143393156|SUPERIORITY|||||||0.1996|||||||Chi-squared|||||||0.1996
71936412|NCT01191255|143393161|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.|ANCOVA|||||||<0.0001
71936413|NCT01191255|143393162|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.|ANCOVA|||||||<0.0001
71936414|NCT01191255|143393163|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71936415|NCT01191255|143393164|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71936416|NCT01191255|143393165|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71936417|NCT02196506|143393166|SUPERIORITY||Mean Difference (Final Values)|-2.3||||0.0074|TWO_SIDED|95.0|-3.97|-0.62|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.62|-3.97|0.0074
71936418|NCT02196506|143393167|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.3331|TWO_SIDED|95.0|-0.66|0.23|||Mixed Models Analysis|||Statistical Analysis at Week 14||0.23|-0.66|0.3331
71936419|NCT02196506|143393168|SUPERIORITY||Mean Difference (Final Values)|-2.25||||0.0263|TWO_SIDED|95.0|-4.23|-0.27|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.27|-4.23|0.0263
71936420|NCT02196506|143393169|SUPERIORITY||Mean Difference (Final Values)|-2.98||||0.0099|TWO_SIDED|95.0|-5.24|-0.72|||Mixed Models Analysis|||Statistical Analysis at Week 14||-0.72|-5.24|0.0099
71936421|NCT01743677|143393186|SUPERIORITY||Least Squares Mean Difference|-1.29|||||TWO_SIDED|90.0|-3.15|0.56||||||||0.56|-3.15|
71936422|NCT01743677|143393187|SUPERIORITY||Least Squares Mean Difference|-1.42|||||TWO_SIDED|90.0|-3.28|0.43||||||||0.43|-3.28|
71936423|NCT01743677|143393188|SUPERIORITY||Least Squares Mean Difference|-2.29|||||TWO_SIDED|90.0|-4.15|-0.44||||||||-0.44|-4.15|
71936424|NCT01743677|143393189|SUPERIORITY||Least Squares Mean Difference|-1.35|||||TWO_SIDED|90.0|-3.21|0.5||||||||0.50|-3.21|
71936425|NCT01743677|143393190|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-0.78|2.93||||||||2.93|-0.78|
71936426|NCT01743677|143393191|SUPERIORITY||Least Squares Mean Difference|0.86|||||TWO_SIDED|90.0|-1.0|2.71||||||||2.71|-1.00|
71936427|NCT01743677|143393192|SUPERIORITY||Least Squares Mean Difference|1.15|||||TWO_SIDED|90.0|-0.71|3.0||||||||3.00|-0.71|
71936428|NCT01743677|143393193|SUPERIORITY||Least Squares Mean Difference|2.15|||||TWO_SIDED|90.0|0.29|4.0||||||||4.00|0.29|
71936429|NCT01743677|143393194|SUPERIORITY||Least Squares Mean Difference|1.35|||||TWO_SIDED|90.0|-0.5|3.21||||||||3.21|-0.50|
71936430|NCT01743677|143393195|SUPERIORITY||Least Squares Mean Difference|11.29|||||TWO_SIDED|90.0|9.62|12.96||||||||12.96|9.62|
71936431|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|0.16|||||TWO_SIDED|90.0|-2.11|2.44||||||0.25 hour post-dose||2.44|-2.11|
71936432|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|1.78|||||TWO_SIDED|90.0|-0.49|4.06||||||0.5 hour post-dose||4.06|-0.49|
71936433|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|2.99|||||TWO_SIDED|90.0|0.71|5.26||||||1 hour post-dose||5.26|0.71|
71936434|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|1.08|||||TWO_SIDED|90.0|-1.19|3.36||||||2 hours post-dose||3.36|-1.19|
71936435|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|2.16|||||TWO_SIDED|90.0|-0.11|4.44||||||4 hours post-dose||4.44|-0.11|
71936436|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|0.05|||||TWO_SIDED|90.0|-2.22|2.33||||||8 hours post-dose||2.33|-2.22|
71936437|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|0.49|||||TWO_SIDED|90.0|-1.79|2.76||||||12 hours post-dose||2.76|-1.79|
71936438|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|2.1|||||TWO_SIDED|90.0|-0.17|4.38||||||16 hours post-dose||4.38|-0.17|
71936439|NCT01743677|143393196|SUPERIORITY||Least Squares Mean Difference|0.79|||||TWO_SIDED|90.0|-1.49|3.06||||||24 hours post-dose||3.06|-1.49|
71936440|NCT01715415|143393207|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.|Percentage of Participants with SVR12|96.3|||||TWO_SIDED|95.0|94.1|98.4|||||95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.|With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).||98.4|94.1|
71936441|NCT01715415|143393208|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.|Fisher Exact|||||||<0.001
71936442|NCT01715415|143393209|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.0|||||TWO_SIDED|95.0|93.0|98.9|||||95% CI calculated using the normal approximation to the binomial distribution.|||98.9|93.0|
71691947|NCT04878055|142898895|SUPERIORITY|||||||0.672|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 195||||0.672
71691948|NCT04878055|142898895|SUPERIORITY|||||||0.153|||||||Wilcoxon (Mann-Whitney)|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||At end of treatment (EoT) - Please note that the number of subjects in this analysis is not 270 but 241||||0.153
71691949|NCT04878055|142898896|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Death, reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.07|||||||Grey's test|||||||0.07
71691950|NCT04878055|142898897|SUPERIORITY|||||||0.07|||||||Gray's test|||number of patients included in the analysis=25||||0.07
71691951|NCT04878055|142898898|SUPERIORITY|Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||||0.668|||||||Gray's test|||Comparison at day 28||||0.668
71691952|NCT04878055|142898899|SUPERIORITY|||||||0.668|||||||Gray's test|||Number of patients included in the analysis = 59||||0.668
71691953|NCT04878055|142898900|SUPERIORITY|||||||0.23|||||||Gray's test|||Estimates are calculated using a nonparametric method for cumulative incidence function with competing risks data. The null hypothesis is that the cumulative incidence functions are identical across treatment groups and estimates are calculated taking into consideration the following competing risks: Reasons for discontinuation for Adverse events and patient transferred to another institution.||||0.23
71936443|NCT01715415|143393210|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.7|||||TWO_SIDED|95.0|93.6|99.9||||||||99.9|93.6|
71691954|NCT04878055|142898901|SUPERIORITY|||||||0.444|||||||Wilcoxon (Mann-Whitney)|||day 3 - please note that the number of subjects in this analysis is not 270 but 255||||0.444
71691955|NCT04878055|142898901|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||day 7 - please note that the number of subjects in this analysis is not 270 but 246||||0.357
71691956|NCT04878055|142898901|SUPERIORITY|||||||0.484|||||||Wilcoxon (Mann-Whitney)|||day 14 - please note that the number of subjects in this analysis is not 270 but 209||||0.484
71691957|NCT04878055|142898901|SUPERIORITY|||||||0.753|||||||Wilcoxon (Mann-Whitney)|||day 21 - please note that the number of subjects in this analysis is not 270 but 176||||0.753
71691958|NCT04878055|142898901|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||day 28 - please note that the number of subjects in this analysis is not 270 but 190||||0.26
71691959|NCT04878055|142898901|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||day 60 - please note that the number of subjects in this analysis is not 270 but 201||||0.19
71691960|NCT04878055|142898901|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||day 90 - please note that the number of subjects in this analysis is not 270 but 18||||1.000
71691961|NCT04878055|142898901|SUPERIORITY|||||||0.074|||||||Wilcoxon (Mann-Whitney)|||EOS - please note that the number of subjects in this analysis is not 270 but 229||||0.074
71691962|NCT04878055|142898901|SUPERIORITY|||||||0.193|||||||two-sample Mann-Whitney U test|||EOT - please note that the number of subjects in this analysis is not 270 but 241||||0.193
71691963|NCT04878055|142898901|SUPERIORITY|||||||0.131|||||||two-sample Mann-Whitney U test|||Hospital discharge - please note that the number of subjects in this analysis is not 270 but 195||||0.131
71691964|NCT04878055|142898902|SUPERIORITY|||||||0.997|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270 but 155.||||0.997
71691965|NCT04878055|142898902|SUPERIORITY|||||||0.712|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270 but 143.||||0.712
71691966|NCT04878055|142898902|SUPERIORITY|||||||0.241|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270 but 115.||||0.241
71691967|NCT04878055|142898902|SUPERIORITY|||||||0.528|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270 but 92.||||0.528
71691968|NCT04878055|142898902|SUPERIORITY|||||||0.814|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270 but 106.||||0.814
71691969|NCT04878055|142898902|SUPERIORITY|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||at EOT - Please note that the number of subjects in this analysis is not 270 but 115.||||0.242
71691970|NCT04878055|142898902|SUPERIORITY|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||at hospital discharge (HD) - Please note that the number of subjects in this analysis is not 270 but 65.||||0.722
71691971|NCT04878055|142898903|SUPERIORITY|||||||0.053|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 246.||||0.053
71691972|NCT04878055|142898903|SUPERIORITY|||||||0.245|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 225.||||0.245
71691973|NCT04878055|142898903|SUPERIORITY|||||||0.067|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 118.||||0.067
71691974|NCT04878055|142898903|SUPERIORITY|||||||0.051|||||||two-sample Mann-Whitney U test|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 54.||||0.051
71936444|NCT03586830|143393235|SUPERIORITY||Difference of least square (LS) means|-4.56|STANDARD_ERROR_OF_MEAN|0.757|<|0.001|TWO_SIDED|95.0|-6.05|-3.06|||Hochberg Approach|||||-3.06|-6.05|<.001
71936445|NCT03586830|143393235|SUPERIORITY||Difference of LS Means|-5.85|STANDARD_ERROR_OF_MEAN|0.755|<|0.001|TWO_SIDED|95.0|-7.34|-4.36|||Hochberg Approach|||||-4.36|-7.34|<.001
71936446|NCT03586830|143393235|SUPERIORITY||Difference of LS Means|-7.23|STANDARD_ERROR_OF_MEAN|0.748|<|0.001|TWO_SIDED|95.0|-8.7|-5.75|||Hochberg Approach|||||-5.75|-8.70|<.001
71691975|NCT04878055|142898903|SUPERIORITY|||||||0.684|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 32.||||0.684
71691976|NCT04878055|142898903|SUPERIORITY|||||||1|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 246, but it is 14.||||1.00
71691977|NCT04878055|142898903|SUPERIORITY|||||||0.48|||||||two-sample Mann-Whitney U test|||at Day 60 - Please note that the number of subjects in this analysis is not 246, but it is 3.||||0.48
71691978|NCT04878055|142898903|SUPERIORITY|||||||0.638|||||||two-sample Mann-W hitney U test|||at Hospital discharge - Please note that the number of subjects in this analysis is 152.||||0.638
71691979|NCT04878055|142898903|SUPERIORITY|||||||0.137|||||||two-sample Mann-W hitney U test|||at EoT - Please note that the number of subjects in this analysis is 212.||||0.137
71691980|NCT04878055|142898904|SUPERIORITY|||||||0.399|||||||Wilcoxon (Mann-Whitney)|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 157||||0.399
71691981|NCT04878055|142898904|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 139||||0.07
71691982|NCT04878055|142898904|SUPERIORITY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 73||||0.4
71691983|NCT04878055|142898904|SUPERIORITY|||||||0.517|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 23||||0.517
71691984|NCT04878055|142898904|SUPERIORITY|||||||0.445|||||||Wilcoxon (Mann-Whitney)|||at day 28 - Please note that the number of subjects in this analysis is not 270, but it is 17||||0.445
71691985|NCT04878055|142898904|SUPERIORITY|||||||0.324|||||||Wilcoxon (Mann-Whitney)|||at EoT - Please note that the number of subjects in this analysis is not 270, but it is 113||||0.324
71691986|NCT04878055|142898904|SUPERIORITY|||||||0.752|||||||Wilcoxon (Mann-Whitney)|||at Hospital discharge - Please note that the number of subjects in this analysis is not 270, but it is 67.||||0.752
71691987|NCT04878055|142898905|SUPERIORITY|||||||0.447|||||||two-sample Mann-Whitney U test|||Please note that the number of patients in this analysis is not 270 but 255, because patients who used supplement oxygen were 174 in the Reparixin group and 81 in the placebo group.||||0.447
71691988|NCT04878055|142898906|SUPERIORITY|||||||0.065||||||Comparison between treatment arms is performed by means of a Chi-squared test|Chi-squared|||At day 28 - Please note that the number of patients in this analysis is not 270 but 245, because patients requiring IMV or ECMO were 163 in the Reparixin group and 82 in the placebo group.||||0.065
71691989|NCT04878055|142898906|SUPERIORITY|||||||0.072|||||||Chi-squared|Comparison between treatment arms is performed by means of a Chi-squared test||||||0.072
71691990|NCT04878055|142898907|SUPERIORITY|||||||0.485||||||Number of subjects included in analysis: 98|two-sample Mann-Whitney U test|||||||0.485
71691991|NCT04878055|142898908|SUPERIORITY|||||||0.267|||||||two-sample Mann-Whitney U test|||Number of subjects included in analysis: 17||||0.267
71691992|NCT04878055|142898909|SUPERIORITY|||||||0.137|||||||two-sample Mann-Whitney U test|||||||0.137
71691993|NCT04878055|142898910|SUPERIORITY|||||||0.002|||||||two-sample Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is 168||||0.002
71691994|NCT04878055|142898910|SUPERIORITY|||||||0.943|||||||two-sample Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 168, but it is 146||||0.943
71691995|NCT04878055|142898910|SUPERIORITY|||||||0.88|||||||two-sample Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 168, but it is 76||||0.88
71691996|NCT04878055|142898910|SUPERIORITY|||||||0.458|||||||Wilcoxon (Mann-Whitney)|||at day 21 - Please note that the number of subjects in this analysis is not 168, but it is 38||||0.458
71691997|NCT04878055|142898910|SUPERIORITY|||||||0.285|||||||two-sample Mann-Whitney U test|||at day 28 - Please note that the number of subjects in this analysis is not 168, but it is 23.||||0.285
71691998|NCT04878055|142898910|SUPERIORITY|||||||0.885|||||||two-sample Mann-Whitney U test|||at EOS - Please note that the number of subjects in this analysis is not 168, but it is 8||||0.885
71691999|NCT04878055|142898910|SUPERIORITY||||||=|0.583|||||||two-sample Mann-Whitney U test|||at HD - Please note that the number of subjects in this analysis is not 270, but it is 74||||= 0.583
71692000|NCT04878055|142898910|SUPERIORITY|||||||0.5|||||||two-sample Mann-Whitney U test|||at End of treatment - Please note that the number of subjects in this analysis is not 270, but it is 131.||||0.5
71692001|NCT04878055|142898911|SUPERIORITY|||||||0.005||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test|Mann-Whitney U test|||at day 3 - Please note that the number of subjects in this analysis is not 270, but it is 245||||0.005
71692002|NCT04878055|142898911|SUPERIORITY|||||||0.283||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 7 - Please note that the number of subjects in this analysis is not 270, but it is 221||||0.283
71692003|NCT04878055|142898911|SUPERIORITY|||||||0.512||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||at day 14 - Please note that the number of subjects in this analysis is not 270, but it is 117||||0.512
71692004|NCT04878055|142898911|SUPERIORITY|||||||0.174|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 21 - Please note that the number of subjects in this analysis is not 270, but it is 51||||0.174
71692005|NCT04878055|142898911|SUPERIORITY|at EOT - Please note that the number of subjects in this analysis is not 270, but it is 206||||||0.133|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||||||0.133
71692006|NCT04878055|142898911|SUPERIORITY|||||||0.009|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||at day 28 ± 2 - Please note that the number of subjects in this analysis is not 270, but it is 29||||0.009
71692007|NCT04878055|142898911|SUPERIORITY|||||||0.593|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to HD - Please note that the number of subjects in this analysis is not 270, but it is 144||||0.593
71692008|NCT04878055|142898911|SUPERIORITY|||||||0.54|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 60 - Please note that the number of subjects in this analysis is not 270, but it is 3||||0.540
71692009|NCT04878055|142898911|SUPERIORITY|||||||0.224|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to EOS - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.224
71692010|NCT04878055|142898912|SUPERIORITY|||||||0.68|||||||Mann-Whitney U test|Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.||to day 3 - Please note that the number of subjects in this analysis is not 270, but it is 15||||0.68
71692011|NCT04878055|142898912|SUPERIORITY|||||||0.272||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 7 - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.272
71692012|NCT04878055|142898912|SUPERIORITY|||||||1||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 14 - Please note that the number of subjects in this analysis is not 270, but it is 13||||1.000
71692013|NCT04878055|142898912|SUPERIORITY|||||||0.903||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 21 - Please note that the number of subjects in this analysis is not 270, but it is 9||||0.903
71692014|NCT04878055|142898912|SUPERIORITY|||||||0.432||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to EOT - Please note that the number of subjects in this analysis is not 270, but it is 13||||0.432
71692015|NCT04878055|142898912|SUPERIORITY|||||||0.105||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to day 28 - Please note that the number of subjects in this analysis is not 270, but it is 6||||0.105
71692016|NCT04878055|142898912|SUPERIORITY|||||||0.551||||||Comparison between treatment arms is performed by means of two-sample Mann-Whitney U test.|Mann-Whitney U test|||to HD - Please note that the number of subjects in this analysis is not 270, but it is 8||||0.551
71692017|NCT04878055|142898913|SUPERIORITY||Odds Ratio (OR)|0.52||||0.232|TWO_SIDED|95.0|0.178|1.522||Analysis is based on logistic regression model with proportion of patients died up to Day 60 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Regression, Logistic|||up to day 60||1.522|0.178|0.232
71692018|NCT04878055|142898913|SUPERIORITY|Analysis is based on logistic regression model with proportion of patients died up to Day 90 as dependent variable, treatment, age group, gender and presence of concomitant disease at baseline as qualitative independent variables.|Odds Ratio (OR)|0.246||||0.158|TWO_SIDED|95.0|0.034|1.782|||Regression, Logistic|||Up to Day 90||1.782|0.034|0.158
71692019|NCT04878055|142898914|SUPERIORITY|Freedom from (time to) death or respiratory failure (need of invasive mechanical ventilation or ECMO or admission to ICU linked to worsening of respiratory parameters compared to baseline) up to Day 90 was performed using the same Kaplan-Meier analysis and the one-sided log-rank test that were used to test for differences between groups||||||0.33607|||||||Log Rank|||||||0.33607
71692020|NCT02372344|142898918|SUPERIORITY_OR_OTHER||Geometric least square (LS) mean ratio|0.64|||||TWO_SIDED|95.0|0.54|0.77||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.77|0.54|
71692021|NCT02372344|142898918|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.71|||||TWO_SIDED|95.0|0.59|0.86||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.86|0.59|
71692022|NCT02372344|142898919|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.35|||||TWO_SIDED|95.0|0.27|0.47||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.47|0.27|
71692023|NCT02372344|142898919|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.44|||||TWO_SIDED|95.0|0.33|0.59||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.59|0.33|
71692024|NCT02372344|142898919|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.46|||||TWO_SIDED|95.0|0.36|0.57||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.57|0.36|
71692025|NCT02372344|142898919|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.57|||||TWO_SIDED|95.0|0.45|0.71||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.71|0.45|
71692026|NCT02372344|142898920|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.56|||||TWO_SIDED|95.0|0.45|0.69||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.45|
71692027|NCT02372344|142898920|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.55||||||95.0|0.44|0.69||||||Total EPA: Ratio of Before Meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||0.69|0.44|
71692028|NCT02372344|142898920|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.87|||||TWO_SIDED|95.0|0.73|1.04||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.04|0.73|
71692029|NCT02372344|142898920|SUPERIORITY_OR_OTHER||Geometric LS mean ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.||1.02|0.72|
71692030|NCT02427841|142898951|SUPERIORITY|Tested against the standard R0 rate of 37%. Given all evaluable patients are included in the denominator, R0 of 56% was not achieved. Specifically, of the 19 evaluable patients, 11 proceeded to surgery. Of the 11 who underwent surgery, 8 \[42% of those enrolled, but 72.7% of those resected\] achieved R0 resection.|binomial|42.0||||0.404|TWO_SIDED|95.0|20.0|67.0||Study was underpowered.|2-sided exact binomial||Test for superiority over standard R0 resection rate of 37%. Study was closed due to slow enrollment, meaning the primary endpoint was underpowered with only 19 of an expected 44 patients enrolled.|Study closed early due to lack of enrollment. Study expected to enrolled 44 evaluable patients to achieve 83% power using the 2-sided binomial test at 10% significance. Study enrolled only 19 evaluable patients, meaning the study was underpowered at \< 62%||67|20|.404
71692031|NCT02849743|142898989|OTHER||Least Means Square|-0.5||||0.92|TWO_SIDED||||||Regression, Linear|||||||0.92
71692032|NCT02849743|142898990|OTHER||Regression Coefficient|-15784.0||||0.57|TWO_SIDED||||||Regression, Linear|||||||0.57
71692033|NCT02849743|142898991|OTHER||Regression Coefficient|48.0||||0.21|TWO_SIDED||||||Mixed Models Analysis|||||||0.21
71692034|NCT02849743|142898992|OTHER||Regression Coefficient|-2.8||||0.55|TWO_SIDED||||||Regression, Linear|||||||0.55
71692035|NCT02849743|142898993|OTHER||Regression Coefficient|1.2||||0.86|TWO_SIDED||||||Regression, Linear|||||||0.86
71692036|NCT02849743|142898994|OTHER||Regression Coefficient|2.4||||0.88|TWO_SIDED||||||Regression, Linear|||||||0.88
71692037|NCT02849743|142898995|OTHER||Regression Coefficient|-0.02||||0.5|TWO_SIDED||||||Regression, Linear|||||||0.50
71692038|NCT02849743|142898996|OTHER||Regression Coefficient|-0.02||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
71692039|NCT02849743|142898998|OTHER||Regression Coefficient|-0.7||||0.68|TWO_SIDED||||||Regression, Linear|||||||0.68
71692040|NCT02849743|142898999|OTHER||Regression Coefficient|-0.6||||0.52|TWO_SIDED||||||Regression, Linear|||||||0.52
71692041|NCT02849743|142899000|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Anxiety||||0.91
71692042|NCT02849743|142899000|OTHER||Regression Coefficient|-0.2||||0.91|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Depression||||0.91
71692043|NCT02849743|142899000|OTHER||Regression Coefficient|4.7||||0.04|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Cognition||||0.04
71692044|NCT02849743|142899000|OTHER||Regression Coefficient|2.3||||0.36|TWO_SIDED||||||Regression, Linear|||Neuro-QoL - Social Function||||0.36
71692045|NCT02849743|142899001|OTHER||Regression Coefficient|0.05||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
71692046|NCT02849743|142899002|OTHER||Regression Coefficient|0.05||||0.83|TWO_SIDED||||||Regression, Linear|||||||0.83
71692047|NCT04607135|142899031|OTHER|||||||0.0003||||||F-statistic = 11.71|Welch's ANOVA|||||||0.0003
71692048|NCT04607135|142899031|OTHER|||||||0.002||||||q-statistic = 6.74|Games-Howell post-hoc test|||||||0.002
71692049|NCT04607135|142899031|OTHER|||||||0.24||||||q-statistic = 2.34|Games-Howell post-hoc test|||||||0.24
71692050|NCT04607135|142899031|OTHER|||||||0.35||||||q-statistic = 2.04|Games-Howell post-hoc test|||||||0.35
71692051|NCT04607135|142899032|OTHER|||||||0.99|||||||Kruskal-Wallis|||||||0.99
71692052|NCT04607135|142899033|OTHER|||||||0.74|||||||Kruskal-Wallis|||||||0.74
71692053|NCT00327717|142899063|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||ANOVA|||||||0.028
71692054|NCT00327717|142899064|SUPERIORITY_OR_OTHER|||||||0.253||95.0|||||ANOVA|||||||0.253
71692055|NCT00327717|142899065|SUPERIORITY_OR_OTHER|||||||0.211||95.0|||||ANOVA|||||||0.211
71692056|NCT00327717|142899066|SUPERIORITY_OR_OTHER|||||||0.516||95.0|||||ANOVA|||||||0.516
71692057|NCT00327717|142899067|SUPERIORITY_OR_OTHER|||||||0.044|||||||X^2 test|||||||0.044
71692058|NCT00327717|142899068|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
71692059|NCT00327717|142899069|SUPERIORITY_OR_OTHER|||||||0.09||95.0|||||X^2 test|||||||0.090
71692060|NCT00327717|142899070|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||X^2 test|||||||0.162
71692061|NCT00327717|142899071|SUPERIORITY_OR_OTHER|||||||0.678||95.0|||||X^2 test|||||||0.678
71692062|NCT00905424|142899073|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.3||||0.0902|TWO_SIDED|90.0|-4.5|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-4.5|0.0902
71692063|NCT00905424|142899074|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.3091|TWO_SIDED|90.0|-2.4|0.6||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.6|-2.4|0.3091
71692064|NCT00905424|142899075|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.0573|TWO_SIDED|90.0|-3.7|-0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.3|-3.7|0.0573
71692065|NCT00905424|142899076|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2368||95.0|||||Cochran-Mantel-Haenszel|||||||0.2368
71692066|NCT00905424|142899079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.0463|TWO_SIDED|90.0|-5.4|-0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||-0.5|-5.4|0.0463
71692067|NCT00905424|142899079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0||||0.1431|TWO_SIDED|90.0|-4.3|0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||0.3|-4.3|0.1431
71692068|NCT00905424|142899079|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3||||0.0281|TWO_SIDED|90.0|-5.8|-0.8||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||-0.8|-5.8|0.0281
71692069|NCT00905424|142899080|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0||||0.092|TWO_SIDED|90.0|-6.0|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-6.0|0.0920
71692070|NCT00905424|142899081|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.0774|TWO_SIDED|90.0|-2.2|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.2|0.0774
71692071|NCT00905424|142899082|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.2||||0.4726|TWO_SIDED|90.0|-1.6|4.0||The test was performed a priori at the significance level of 0.10|ANCOVA|||||4.0|-1.6|0.4726
71692072|NCT00905424|142899083|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.5182|TWO_SIDED|90.0|-1.4|3.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||3.1|-1.4|0.5182
71692073|NCT00905424|142899084|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.9||||0.463|TWO_SIDED|90.0|-3.1|1.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||||1.2|-3.1|0.4630
71692074|NCT00905424|142899085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.523||95.0|||||Cochran-Mantel-Haenszel|||||||0.5230
71692075|NCT00905424|142899088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.8||||0.2876|TWO_SIDED|90.0|-1.0|4.7||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite||4.7|-1.0|0.2876
71692076|NCT00905424|142899088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.1||||0.559|TWO_SIDED|90.0|-2.1|4.4||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index||4.4|-2.1|0.5590
71936447|NCT04578548|143393239|SUPERIORITY||Geometric Mean Difference|-0.91||||0.606|TWO_SIDED|95.0|-4.34|2.64|||Random coefficient regression model|||Based on a random coefficient regression model (linear slope model) on htTKV log-transformed values with time (in weeks) as a continuous variable, treatment, time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||2.64|-4.34|0.606
71692077|NCT00905424|142899088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3||||0.2079|TWO_SIDED|90.0|-0.7|5.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index||5.2|-0.7|0.2079
71692078|NCT00905424|142899089|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.7||||0.1489|TWO_SIDED|90.0|-8.0|0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||||0.5|-8.0|0.1489
71692079|NCT00905424|142899090|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.4||||0.0852|TWO_SIDED|90.0|-2.8|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA|||||-0.1|-2.8|0.0852
71692080|NCT01509612|142899109|SUPERIORITY|||||||0.397|||||||t-test, 2 sided|||||||0.397
71692081|NCT01509612|142899110|SUPERIORITY|||||||0.02|||||||Chi-squared|||Only those groups were compared who received an intervention||||0.02
71692082|NCT00627926|142899129|SUPERIORITY_OR_OTHER||Difference in percentage|23.0|||||TWO_SIDED|95.0|15.9|30.0||||||||30.0|15.9|
71692083|NCT00627926|142899129|SUPERIORITY_OR_OTHER||Difference in percentage|29.2|||||TWO_SIDED|95.0|22.4|36.1||||||||36.1|22.4|
71692084|NCT00627926|142899130|SUPERIORITY_OR_OTHER||Difference in percentage|57.1|||||TWO_SIDED|95.0|51.4|62.8||||||||62.8|51.4|
71692085|NCT00627926|142899130|SUPERIORITY_OR_OTHER||Difference in percentage|58.4|||||TWO_SIDED|95.0|52.7|64.0||||||||64.0|52.7|
71692086|NCT00627926|142899131|SUPERIORITY_OR_OTHER||Difference in percentage|48.8|||||TWO_SIDED|95.0|43.0|54.6||||||||54.6|43.0|
71692087|NCT00627926|142899131|SUPERIORITY_OR_OTHER||Difference in percentage|50.4|||||TWO_SIDED|95.0|44.6|56.2||||||||56.2|44.6|
71692088|NCT00627926|142899132|SUPERIORITY_OR_OTHER||Difference in percentage|35.7|||||TWO_SIDED|95.0|29.0|42.4||||||||42.4|29.0|
71692089|NCT00627926|142899132|SUPERIORITY_OR_OTHER||Difference in percentage|37.5|||||TWO_SIDED|95.0|30.9|44.1||||||||44.1|30.9|
71692090|NCT00627926|142899133|SUPERIORITY_OR_OTHER||Difference in percentage|17.6|||||TWO_SIDED|95.0|11.2|24.0||||||||24.0|11.2|
71692091|NCT00627926|142899133|SUPERIORITY_OR_OTHER||Difference in percentage|23.1|||||TWO_SIDED|95.0|17.0|29.2||||||||29.2|17.0|
71692092|NCT00627926|142899134|SUPERIORITY_OR_OTHER||Difference in percentage|25.5|||||TWO_SIDED|95.0|18.5|32.4||||||||32.4|18.5|
71692093|NCT00627926|142899134|SUPERIORITY_OR_OTHER||Difference in percentage|31.2|||||TWO_SIDED|95.0|24.4|37.9||||||||37.9|24.4|
71692094|NCT00627926|142899135|SUPERIORITY_OR_OTHER||Difference in percentage|25.2|||||TWO_SIDED|95.0|18.2|32.2||||||||32.2|18.2|
71692095|NCT00627926|142899135|SUPERIORITY_OR_OTHER||Difference in percentage|31.7|||||TWO_SIDED|95.0|24.9|38.5||||||||38.5|24.9|
71692096|NCT00627926|142899140|SUPERIORITY_OR_OTHER||Difference in percentage|24.9|||||TWO_SIDED|95.0|17.9|31.9||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||31.9|17.9|
71692097|NCT00627926|142899140|SUPERIORITY_OR_OTHER||Difference in percentage|30.9|||||TWO_SIDED|95.0|24.1|37.7||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).||37.7|24.1|
71692098|NCT00627926|142899140|SUPERIORITY_OR_OTHER||Difference in percentage|25.7|||||TWO_SIDED|95.0|18.8|32.6||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||32.6|18.8|
71692099|NCT00627926|142899140|SUPERIORITY_OR_OTHER||Difference in percentage|32.5|||||TWO_SIDED|95.0|25.9|39.2||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.||39.2|25.9|
71692100|NCT02797678|142899149|SUPERIORITY|||||||0.061|||||||paired t-test|||||||0.061
71692101|NCT02797678|142899152|SUPERIORITY|||||||0.301|||||||paired t-test|||||||0.301
71936448|NCT04578548|143393241|SUPERIORITY||Least-squares mean difference|-2.31||||0.171|TWO_SIDED|95.0|-5.64|1.02|||Random coefficient regression model|||Least-squares mean difference (95% CI) from a random coefficient regression model (linear slope model) on eGFR values with time (in weeks) as a continuous variable, the time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.||1.02|-5.64|0.171
71936449|NCT00395083|143393245|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Log Rank|||||1.80|0.70|0.62
71936450|NCT00395083|143393246|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.62|TWO_SIDED|95.0|0.7|1.8|||Regression, Cox|||||1.80|0.70|0.62
71936451|NCT00395083|143393247|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.003|TWO_SIDED|95.0|1.46|6.17|||Regression, Cox|||||6.17|1.46|0.003
71936452|NCT00395083|143393248|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.0||||0.002|TWO_SIDED|95.0|1.46|6.17|||Log Rank|||||6.17|1.46|0.002
71936453|NCT00972153|143393249|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
71936454|NCT00972153|143393250|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.||||<0.001
71936455|NCT04136626|143393251|SUPERIORITY||Mean Difference (Final Values)|-2.0475||||0.0871|TWO_SIDED|95.0|-4.3977|0.3027||The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in Y-BOCS total scores between the treatment groups at endpoint (week 12).||0.3027|-4.3977|0.0871
71936456|NCT04136626|143393251|SUPERIORITY||Difference in the amount of change|-3.4385||||0.0036|TWO_SIDED|95.0|-5.7394|-1.1376||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment Y-BOCS total scores between the treatment groups.||-1.1376|-5.7394|0.0036
71936457|NCT04136626|143393252|SUPERIORITY||Mean Difference (Final Values)|-0.8743||||0.3616|TWO_SIDED|95.0|-2.7666|1.0181||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in depression severity (QIDS-SR total scores) between the treatment groups at endpoint (week 12).||1.0181|-2.7666|0.3616
71692102|NCT01462110|142899165|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.234|STANDARD_ERROR_OF_MEAN|0.0211|<|0.001|TWO_SIDED|95.0|-0.276|-0.192|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.192|-0.276|<0.001
71936458|NCT04136626|143393252|SUPERIORITY||Difference in the amount of change|-1.3076||||0.1973|TWO_SIDED|95.0|-3.3014|0.6862||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment depression severity (QIDS-SR total scores) between the treatment groups.||0.6862|-3.3014|0.1973
71936459|NCT04136626|143393253|SUPERIORITY||Mean Difference (Final Values)|-2.7992||||0.1289|TWO_SIDED|95.0|-6.4246|0.8262||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in functional impairment (WSAS total scores) between the treatment groups at endpoint (week 12).||0.8262|-6.4246|0.1289
71936460|NCT04136626|143393253|SUPERIORITY||Difference in the amount of change|-4.5704||||0.0137|TWO_SIDED|95.0|-8.1939|-0.9468||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment functional impairment (WSAS total scores) between the treatment groups.||-0.9468|-8.1939|0.0137
71936461|NCT04136626|143393254|SUPERIORITY||Mean Difference (Final Values)|4.3953||||0.1796|TWO_SIDED|95.0|-2.0543|10.8448||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the Perspectives OCD group outcome compared to the Health and Well-Being Program group outcome at the trial end-point (week 12).|Null hypothesis: there is no significant difference in quality of life (Q-LES-Q-SF percentage scores) between the treatment groups at endpoint (week 12).||10.8448|-2.0543|0.1796
71936462|NCT04136626|143393254|SUPERIORITY||Difference in the amount of change|6.7962||||0.04|TWO_SIDED|95.0|0.314|13.2785||The a priori threshold for statistical significance was alpha=.05.|Mixed Models Analysis|Repeated measures were modeled with a first-order heterogeneous auto-regressive (ARH(1)) covariance structure.|The effect is presented as the difference in the amount of symptom reduction (week 12 - week 0) between Perspectives OCD and the Health and Well-Being Program group (i.e., a group difference in the amount of change over time).|Null hypothesis: there is no significant difference in the change from baseline to end-of-treatment quality of life (Q-LES-Q-SF percentage scores) between the treatment groups.||13.2785|0.3140|0.0400
71692103|NCT01462110|142899166|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-1.232|STANDARD_ERROR_OF_MEAN|0.0806|<|0.001|TWO_SIDED|95.0|-1.392|-1.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-1.071|-1.392|<0.001
71936463|NCT00325403|143393305|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|23.0||||0.0125|TWO_SIDED|95.0|4.0|41.0||P-Value|ANCOVA|||Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.||41|4|0.0125
71936464|NCT00325403|143393306|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|13.0||||0.0653|TWO_SIDED|95.0|-2.0|33.0|||ANCOVA|||||33|-2|0.0653
71936465|NCT00325403|143393307|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0307|TWO_SIDED|95.0|1.0|33.0|||ANCOVA|||||33|1|0.0307
71936466|NCT00325403|143393308|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|12.0||||0.0518|TWO_SIDED|95.0|0.0|24.0|||ANCOVA|||||24|0|0.0518
71936467|NCT00325403|143393309|SUPERIORITY_OR_OTHER_LEGACY|||||||1||95.0|||||Fisher Exact|||||||1.000
71936468|NCT00325403|143393310|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.738|TWO_SIDED|95.0|0.0|0.0||"In cases where the value corresponding to overall poorest relative change was imputed for walk distance, a value of IV was used for the WHO functional classification for PAH."|Wilcoxon rank sum test||The values for the estimated parameter and 95% confidence interval were calculated.|||0|0|0.7380
71692104|NCT01462110|142899167|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.106|STANDARD_ERROR_OF_MEAN|0.0173|<|0.001|TWO_SIDED|95.0|-0.14|-0.071|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.071|-0.140|<0.001
71692105|NCT01462110|142899168|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.83|STANDARD_ERROR_OF_MEAN|0.0957|<|0.001|TWO_SIDED|95.0|-1.02|-0.639|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.639|-1.020|<0.001
71936469|NCT00325403|143393311|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.4887|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||||0|-1|0.4887
71936470|NCT00325403|143393312|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|0.0||||0.6116|TWO_SIDED|95.0|0.0|1.0|||Wilcoxon sum-rank test|||||1|0|0.6116
71936471|NCT00325403|143393314|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|26.0||||0.0326|TWO_SIDED|95.0|1.0|49.0|||ANCOVA|||||49|1|0.0326
71936472|NCT00325403|143393315|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|16.0||||0.2275|TWO_SIDED|95.0|-15.0|47.0|||ANCOVA|||||47|-15|0.2275
71936473|NCT00325403|143393316|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|32.0||||0.0024|TWO_SIDED|95.0|10.0|55.0|||ANCOVA|||||55|10|0.0024
71936474|NCT00325403|143393317|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|25.5||||0.0001|TWO_SIDED|95.0|10.0|41.0|||ANCOVA|||||41|10|0.0001
71936475|NCT00325403|143393318|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|17.0||||0.0025|TWO_SIDED|95.0|3.0|33.0|||ANCOVA|||||33|3|0.0025
71936476|NCT00325403|143393319|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|20.0||||0.0008|TWO_SIDED|95.0|7.0|34.0|||ANCOVA|||||34|7|0.0008
71936477|NCT00325403|143393320|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann (H-L)|14.0||||0.0025|TWO_SIDED|95.0|3.9|25.0|||ANCOVA|||||25|3.9|0.0025
71936478|NCT02363010|143393330|SUPERIORITY|||||||0.68||||||A prior threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 12 month weight losses.||||.68
71936479|NCT02363010|143393330|SUPERIORITY|||||||0.11||||||A prior threshold for significance was p\<.05.|ANOVA|Controlling for baseline weight.||Exploring group differences in 18 month weight losses.||||.11
71936480|NCT02363010|143393331|SUPERIORITY|||||||0.41||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).||||.41
71936481|NCT02363010|143393331|SUPERIORITY|||||||0.46||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.46
71936482|NCT02363010|143393331|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p\< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 12 month MVPA.||||.82
71936483|NCT02363010|143393331|SUPERIORITY|||||||0.42||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.42
71936484|NCT02363010|143393331|SUPERIORITY|||||||0.28||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.28
71936485|NCT02363010|143393331|SUPERIORITY|||||||0.82||||||A priori threshold for statistical significance was p \< .05.|Compound Poisson general linear models|Controlling for baseline MVPA.||Exploring group differences in 18 month MVPA.||||.82
71936486|NCT02363010|143393332|SUPERIORITY|||||||0.06||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.||||.06
71936487|NCT02363010|143393332|SUPERIORITY|||||||0.3||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline half-mile walk time.||Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.||||.30
71936488|NCT02363010|143393333|SUPERIORITY|||||||0.59||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 12 month waist circumference.||||.59
71936489|NCT02363010|143393333|SUPERIORITY|||||||0.57||||||A priori threshold for statistical significance was p \< .05.|ANOVA|Controlling for baseline waist circumference.||Exploring group differences in 18 month waist circumference.||||.57
71936490|NCT02363010|143393334|SUPERIORITY|||||||0.978||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.978
71692106|NCT01462110|142899169|SUPERIORITY|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.044|STANDARD_ERROR_OF_MEAN|0.0076|<|0.001|TWO_SIDED|95.0|-0.059|-0.029|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.029|-0.059|<0.001
71936491|NCT02363010|143393334|SUPERIORITY|||||||0.998||||||A priori threshold for statistical significance was p \<.05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.998
71936492|NCT02363010|143393334|SUPERIORITY|||||||0.878||||||A priori threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.878
71936493|NCT02363010|143393334|SUPERIORITY|||||||0.602||||||A priori threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.602
71936494|NCT02363010|143393335|SUPERIORITY|||||||0.487||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.487
71936495|NCT02363010|143393335|SUPERIORITY|||||||0.262||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.262
71936496|NCT02363010|143393335|SUPERIORITY|||||||0.851||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.851
71936497|NCT02363010|143393335|SUPERIORITY|||||||0.978||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.978
71692107|NCT01462110|142899170|SUPERIORITY|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.06|STANDARD_ERROR_OF_MEAN|0.0087|<|0.001|TWO_SIDED|95.0|-0.078|-0.043|||ANCOVA|Terms for treatment as a factor \& baseline as a covariate.||||-0.043|-0.078|<0.001
71936498|NCT02363010|143393336|SUPERIORITY|||||||0.796||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.796
71936499|NCT02363010|143393336|SUPERIORITY|||||||0.481||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.481
71936500|NCT02363010|143393336|SUPERIORITY|||||||0.872||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.872
71936501|NCT02363010|143393336|SUPERIORITY|||||||0.802||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.802
71936502|NCT02363010|143393337|SUPERIORITY|||||||0.926||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.926
71692108|NCT02499120|142899201|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.18|TWO_SIDED|95.0|0.536|1.253||1-sided p-value was from the log-rank test stratified by stratification factors ECOG(Eastern Cooperative Oncology Group) per randomization.|Log Rank|||||1.253|0.536|0.1800
71692109|NCT02499120|142899202|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.4953|TWO_SIDED|95.0|0.669|1.495||1-sided p-value was from the log-rank test stratified by stratification factors ECOG per randomization.|Log Rank|||||1.495|0.669|0.4953
71936503|NCT02363010|143393337|SUPERIORITY|||||||0.82||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.820
71692110|NCT00534638|142899264|SUPERIORITY||Vaccine effectiveness percentage|49.6||||0.004|TWO_SIDED|95.0|20.1|68.2||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||68.2|20.1|0.004
71692111|NCT00534638|142899264|SUPERIORITY||Vaccine effectiveness percentage|23.8||||0.232|TWO_SIDED|95.0|-19.0|51.1||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.||51.1|-19.0|0.232
71692112|NCT00534638|142899265|SUPERIORITY||Vaccine effectiveness percentage|-52.2||||0.069|TWO_SIDED|95.0|-139.4|3.3||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.||3.3|-139.4|0.069
71936504|NCT02363010|143393337|SUPERIORITY|||||||0.127||||||A prior threshold for statistical significance was p \< .05.|Regression, Linear|Controlling for baseline weight.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.||||.127
71936505|NCT02363010|143393337|SUPERIORITY|||||||0.814||||||A prior threshold for statistical significance was p \< .05.|Regression, Poison|Controlling for baseline MVPA. Poisson linear regression was used as MVPA data distribution was zero-inflated.||The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.||||.814
71936506|NCT04549259|143393347|SUPERIORITY||Odds Ratio (OR)|3.23||||0.33|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.33
71936507|NCT04549259|143393347|SUPERIORITY||Odds Ratio (OR)|1.76||||0.63|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.63
71692113|NCT03705286|142899280|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|1.87||0.78|TWO_SIDED|95.0|-4.21|3.17|||Regression, Linear|||We evaluated whether there are differences in the Physical Component Score (PCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||3.17|-4.21|0.78
71936508|NCT04549259|143393347|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
71692114|NCT03705286|142899280|SUPERIORITY||Mean Difference (Final Values)|-2.98|STANDARD_ERROR_OF_MEAN|2.05||0.15|TWO_SIDED|95.0|-7.03|1.07|||Regression, Linear|||We evaluated whether there are differences in the Mental Component Score (MCS) for QOL between the PU-EVAC and PVC treatment groups by comparing their respective mean scores (i.e., mean\[PU-EVAC\] - mean\[PVC\] ). We modeled the data using linear regression and used robust standard error estimates to construct our statistical test and 95% confidence interval estimates. We also estimated the treatment groups' mean quality of life scores with standard error estimates and 95% confidence intervals.||1.07|-7.03|0.15
71692115|NCT03705286|142899281|SUPERIORITY||Risk Difference (RD)|0.05||||0.05|TWO_SIDED|98.0|-0.07|0.17|||Regression, Logistic|||||0.17|-0.07|0.05
71936509|NCT04549259|143393347|SUPERIORITY||Odds Ratio (OR)|0.87||||0.9|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.90
71936510|NCT04549259|143393347|OTHER|Single group change over time.|Odds Ratio (OR)|2.89||||0.38|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.38
71936511|NCT04549259|143393347|OTHER|Single group change over time.|Odds Ratio (OR)|1.25||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.78
71936512|NCT04549259|143393347|OTHER|Single group change over time.|Odds Ratio (OR)|2.32||||0.45|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.45
71936513|NCT04549259|143393347|OTHER|Single group change over time.|Odds Ratio (OR)|0.92||||0.91|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.91
71936514|NCT04549259|143393348|SUPERIORITY||B|2.58|STANDARD_ERROR_OF_MEAN|2.8||0.36|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.36
71936515|NCT04549259|143393348|SUPERIORITY||B|-0.42|STANDARD_ERROR_OF_MEAN|2.78||0.88|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.88
71936516|NCT04549259|143393348|SUPERIORITY||B|0.38|STANDARD_ERROR_OF_MEAN|2.8||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
71692116|NCT03705286|142899282|SUPERIORITY||Risk Difference (RD)|0.126||||0.05|TWO_SIDED|95.0|-0.01|0.26|||Regression, Logistic|||We evaluated whether there are differences in the risk of laryngeal injury between the PU-EVAC and PVC treatment groups, comparing their respective risk difference (i.e., probability\[PU-EVAC\] - probability \[PVC\]). We fit a logistic regression model and incorporated robust (i.e., Huber-White heteroskedastic consistent) standard error estimates for our hypothesis test and 95% confidence interval estimates.||0.26|-0.01|0.05
71692117|NCT01401543|142899283|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric Least Squares (LS) Mean Ratio|0.96|||||TWO_SIDED|90.0|0.91|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.91|
71692118|NCT01401543|142899283|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.89|||||TWO_SIDED|90.0|0.85|0.93|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.93|0.85|
71692119|NCT01401543|142899283|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.88|0.97|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.97|0.88|
71692120|NCT01401543|142899283|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.9|||||TWO_SIDED|90.0|0.86|0.95|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.95|0.86|
71692121|NCT01401543|142899283|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.9|0.99|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.99|0.90|
71692122|NCT01401543|142899283|NON_INFERIORITY_OR_EQUIVALENCE|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|1.02|||||TWO_SIDED|90.0|0.97|1.07|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.07|0.97|
71692123|NCT01401543|142899284|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.84|||||TWO_SIDED|90.0|0.77|0.91|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.91|0.77|
71936517|NCT04549259|143393348|SUPERIORITY||B|-0.99|STANDARD_ERROR_OF_MEAN|2.78||0.73|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.73
71936518|NCT04549259|143393348|OTHER|Single group change over time.|B|4.88|STANDARD_ERROR_OF_MEAN|1.83||0.01|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.01
71692124|NCT01401543|142899284|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.78|||||TWO_SIDED|90.0|0.71|0.85|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.85|0.71|
71692125|NCT01401543|142899284|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||TWO_SIDED|90.0|0.85|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.01|0.85|
71692126|NCT01401543|142899284|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.77|||||TWO_SIDED|90.0|0.7|0.84|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.84|0.70|
71936519|NCT04549259|143393348|OTHER|Single group change over time.|B|3.28|STANDARD_ERROR_OF_MEAN|2.03||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
71936520|NCT04549259|143393348|OTHER|Single group change over time.|B|3.82|STANDARD_ERROR_OF_MEAN|2.06||0.08|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.08
71936521|NCT04549259|143393348|OTHER|Single group change over time.|B|3.19|STANDARD_ERROR_OF_MEAN|1.99||0.12|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.12
71936522|NCT04549259|143393349|SUPERIORITY||Odds Ratio (OR)|22.3||||0.049|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.049
71936523|NCT04549259|143393349|SUPERIORITY||Odds Ratio (OR)|1.86||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
71936524|NCT04549259|143393349|SUPERIORITY||Odds Ratio (OR)|0.68||||0.78|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.78
71936525|NCT04549259|143393349|SUPERIORITY||Odds Ratio (OR)|0.43||||0.54|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a generalized linear mixed model using the glmer function and a logit link in the R package lme4. The model included a random effect for participant. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.54
71936526|NCT04549259|143393349|OTHER|Single group change over time.|Odds Ratio (OR)|6.26||||0.09|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.09
71936527|NCT04549259|143393349|OTHER|Single group change over time.|Odds Ratio (OR)|2.05||||0.4|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.40
71936528|NCT04549259|143393349|OTHER|Single group change over time.|Odds Ratio (OR)|1.42||||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.66
71936529|NCT04549259|143393349|OTHER|Single group change over time.|Odds Ratio (OR)|1.14||||0.87|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.87
71936530|NCT04549259|143393350|SUPERIORITY||B|-1.74|STANDARD_ERROR_OF_MEAN|1.47||0.24|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.24
71936531|NCT04549259|143393350|SUPERIORITY||B|-2.05|STANDARD_ERROR_OF_MEAN|1.46||0.17|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.17
71936532|NCT04549259|143393350|SUPERIORITY||B|0.64|STANDARD_ERROR_OF_MEAN|1.47||0.66|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.66
71936533|NCT04549259|143393350|SUPERIORITY||B|-0.21|STANDARD_ERROR_OF_MEAN|1.46||0.89|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||We fit a linear mixed model using the lmer function in the R package lme4. The model included a random effect for participant and utilized all available data. Predictors (fixed effects) included time (baseline vs. follow-up), random assignments, and interactions between assignments and time. We adjusted for mode of survey completion. Significant interactions indicated differential changes in outcomes over time for those randomly assigned vs. not randomly assigned to different interventions.||||.89
71936534|NCT04549259|143393350|OTHER|Single group change over time.|B|-1.6|STANDARD_ERROR_OF_MEAN|0.75||0.045|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.045
71936535|NCT04549259|143393350|OTHER|Single group change over time.|B|-1.81|STANDARD_ERROR_OF_MEAN|0.95||0.07|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.07
71936536|NCT04549259|143393350|OTHER|Single group change over time.|B|-0.51|STANDARD_ERROR_OF_MEAN|0.88||0.57|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.57
71936537|NCT04549259|143393350|OTHER|Single group change over time.|B|-0.92|STANDARD_ERROR_OF_MEAN|1.12||0.42|TWO_SIDED|||||All tests performed were 2-sided. Given that the study was a pilot, we used α = .25 as a significance level cutoff and focus primarily on patterns in the data and effect sizes.|Mixed Models Analysis|||"Given that our factorial design resulted in many control participants who were assigned to alternative interventions, for this pilot we also report on changes over time in outcomes for participants randomly assigned to each intervention. These changes tested with mixed models that contained only participants assigned to each intervention. Here, time was the predictor of interest, and we again controlled for mode of survey administration."||||.42
71936538|NCT00672620|143393374|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.036||0.577|TWO_SIDED|95.0|-2.61|1.46||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||All statistical tests were 2-sided with 95% confidence intervals (CIs), and with P-values evaluated at the 5% significance level (ie, statistical significance if P\<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||1.46|-2.61|0.577
71936539|NCT00672620|143393374|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.038||0.138|TWO_SIDED|95.0|-3.58|0.5|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||0.50|-3.58|0.138
71936540|NCT00672620|143393374|SUPERIORITY_OR_OTHER||LS Mean Difference|-2.96|STANDARD_ERROR_OF_MEAN|1.047||0.005|TWO_SIDED|95.0|-5.02|-0.91|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||||-0.91|-5.02|0.005
71936541|NCT03211156|143393386|OTHER|||||||0.757|||||||Chi-squared, Corrected|||||||0.757
71936542|NCT03211156|143393387|OTHER|||||||0.048|||||||Fisher Exact|||||||0.048
71936543|NCT00829413|143393388|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|37.8|||<|0.0001|TWO_SIDED|95.0|27.4|48.2|||McNemar|||||48.2|27.4|<.0001
71936544|NCT00829413|143393388|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|40.3|||<|0.0001|TWO_SIDED|95.0|30.4|50.3|||McNemar|||||50.3|30.4|<.0001
71936545|NCT00829413|143393388|SUPERIORITY_OR_OTHER||Difference in Sensitivity (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
71936546|NCT00829413|143393389|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|7.9||||0.138|TWO_SIDED|95.0|-2.4|18.2|||McNemar|||||18.2|-2.4|0.1380
71936547|NCT00829413|143393389|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|28.6|||<|0.0001|TWO_SIDED|95.0|19.7|37.5|||McNemar|||||37.5|19.7|<.0001
71936548|NCT00829413|143393389|SUPERIORITY_OR_OTHER||Difference in Specificity (%)|50.7|||<|0.0001|TWO_SIDED|95.0|42.0|59.5|||McNemar|||||59.5|42.0|<.0001
71936549|NCT00829413|143393390|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|21.6|||<|0.0001|TWO_SIDED|95.0|14.1|29.2|||McNemar|||||29.2|14.1|<.0001
71936550|NCT00829413|143393390|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|34.0|||<|0.0001|TWO_SIDED|95.0|27.3|40.7|||McNemar|||||40.7|27.3|<.0001
71936551|NCT00829413|143393390|SUPERIORITY_OR_OTHER||Difference in Accuracy (%)|75.6|||<|0.0001|TWO_SIDED|95.0|67.9|83.3|||McNemar|||||83.3|67.9|<.0001
71936552|NCT00829413|143393391|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71936553|NCT00829413|143393391|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71936554|NCT00829413|143393391|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71936555|NCT00829413|143393392|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71936556|NCT00829413|143393392|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71936557|NCT00829413|143393392|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wald Test|||||||<.0001
71936558|NCT00124020|143393409|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|0.2||||||95.0|-6.8|7.2||p-values were not calculated in deference to confidence intervals.||||||7.2|-6.8|
71936559|NCT01127581|143393417|SUPERIORITY_OR_OTHER||Median Difference (Net)|-677.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 \& DVI assuming a median time of 1600 minutes for DVI \& 34% dropout rate based on 5% 2-sided test|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
71936560|NCT01127581|143393418|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.|Difference in Populations|-1.1|||||TWO_SIDED|95.0|-5.79|3.59|||Chi-squared||MVI 200 - DVI|The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.||3.59|-5.79|
71936561|NCT01127581|143393419|SUPERIORITY_OR_OTHER||Median Difference (Net)|-543.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.||||<0.001
71936562|NCT01127581|143393420|SUPERIORITY_OR_OTHER||Median Difference (Net)|-390.0|||<|0.001|TWO_SIDED|95.0|||||Log Rank||MVI 200 - DVI|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||<0.001
71936563|NCT01127581|143393421|SUPERIORITY_OR_OTHER||Difference in Proportions|-26.0|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71936564|NCT01127581|143393422|SUPERIORITY_OR_OTHER||Difference in Proportions|9.67|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71936565|NCT01127581|143393423|SUPERIORITY_OR_OTHER||Difference in Proportions|26.96|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71936566|NCT01127581|143393424|SUPERIORITY_OR_OTHER||Difference in Proportions|13.9|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71936567|NCT01127581|143393425|SUPERIORITY_OR_OTHER||Difference in Proportions|29.8|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71936568|NCT01127581|143393426|SUPERIORITY_OR_OTHER||Difference in Proportions|1.68|||<|0.001|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - DVI|||||<0.001
71936569|NCT02927847|143393451|OTHER||t-value|0.138||||0.891|TWO_SIDED||||||t-test, 2 sided|||||||0.891
71936570|NCT02927847|143393452|OTHER||t-value|-0.575||||0.571|TWO_SIDED||||||t-test, 2 sided|||||||0.571
71936571|NCT02927847|143393453|OTHER||Odds Ratio (OR)|1.17||||0.739|TWO_SIDED||||||Regression, Cox|||||||0.739
71936572|NCT00723554|143393475|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.1|||<|0.001|TWO_SIDED|95.0|-6.9|-5.4|||t-test, 2 sided|||Comparison of the change in average inhalation times from Period I (PD-6) to Period II (PD-15)||-5.4|-6.9|<0.001
71936573|NCT00723554|143393479|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.59|TWO_SIDED|95.0|-1.0|0.6|||t-test, 2 sided|||Comparison of the change in average number of days of dosing from Period I (PD-6) to Period II (PD-15)||0.6|-1.0|0.59
71936574|NCT00723554|143393483|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|||<|0.001|TWO_SIDED|95.0|0.2|0.7|||t-test, 2 sided|||Comparison of the change in average number of daily doses from Period I (PD-6) to Period II (PD-15)||0.7|0.2|<0.001
71936575|NCT00723554|143393487|SUPERIORITY_OR_OTHER||Mean Difference (Net)|11.0|||<|0.0001|TWO_SIDED|95.0|6.5|15.6|||t-test, 2 sided|||Comparison of the change in percentage of complete doses delivered from Period I (PD-6) to Period II (PD-15)||15.6|6.5|<0.0001
71936576|NCT01614509|143393515|NON_INFERIORITY_OR_EQUIVALENCE|Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.||||||0.6||95.0|||||Wilcoxon (Mann-Whitney)|||Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups||||0.60
71936577|NCT03255031|143393516|SUPERIORITY|||||||0.067||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.067
71936578|NCT03255031|143393517|SUPERIORITY|||||||0.004||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||||||0.004
71936579|NCT03151499|143393526|OTHER||Geometric mean (gMean) ratio (%)|7.8|STANDARD_ERROR_OF_MEAN|1.19|||TWO_SIDED|90.0|5.74|10.601|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||10.601|5.740|
71936580|NCT03151499|143393527|OTHER||Geometric mean (gMean) ratio (%)|9.77|STANDARD_ERROR_OF_MEAN|1.232|||TWO_SIDED|90.0|6.767|14.098|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|The main focus is on estimation, therefore no hypothesis was tested. The statistical analysis model for the primary endpoints is an ANOVA (analysis of variance). This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||14.098|6.767|
71936581|NCT03151499|143393528|OTHER||Geometric mean (gMean) ratio (%)|8.23|STANDARD_ERROR_OF_MEAN|1.187|||TWO_SIDED|90.0|6.081|11.126|||||gMean ratio = BI 409306 + Rifampicin pretreatment (T) / BI 409306 (R). Standard Error of the mean is actually the Geometric Standard Error.|Since the main focus is on estimation and not testing, therefore no hypothesis was tested.The statistical analysis model is an ANOVA (analysis of variance) model on the logarithmic scale. This model included effects accounting for the following sources of variation: 'subjects' and 'treatment'. The effect 'subjects' will be considered as random, whereas the treatment effect will be considered as fixed. The PK endpoints were log-transformed (natural logarithm) prior to fitting the ANOVA model.||11.126|6.081|
71936582|NCT03563027|143393530|SUPERIORITY||Mean Difference (Net)|433.0||||0.81|TWO_SIDED|95.0|-337.0|1203.0|||Regression, Linear|||||1203|-337|.81
71936583|NCT03563027|143393530|SUPERIORITY||Mean Difference (Net)|1224.0||||0.005|TWO_SIDED|95.0|451.0|1996.0|||Regression, Linear|||||1996|451|.005
71936584|NCT03563027|143393531|SUPERIORITY||Mean Difference (Net)|-160.0||||0.92|TWO_SIDED|95.0|-983.0|663.0|||Regression, Linear|||||663|-983|.92
71936585|NCT03563027|143393531|SUPERIORITY||Mean Difference (Net)|564.0||||0.37|TWO_SIDED|95.0|-261.0|1389.0|||Regression, Linear|||||1389|-261|.37
71936586|NCT03563027|143393532|SUPERIORITY||Median Difference (Net)|0.21|||<|0.001|TWO_SIDED|95.0|0.18|0.24|||Regression, Linear|||||.24|.18|<.001
71936587|NCT03563027|143393532|SUPERIORITY||Mean Difference (Net)|0.34|||<|0.001|TWO_SIDED|95.0|0.31|0.37|||Regression, Linear|||||.37|.31|<.001
71936588|NCT03563027|143393533|SUPERIORITY||Mean Difference (Net)|0.09|||<|0.001|TWO_SIDED|95.0|0.06|0.1|||Regression, Linear|||||0.1|.06|<.001
71936589|NCT03563027|143393533|SUPERIORITY||Median Difference (Net)|0.18|||<|0.001|TWO_SIDED|95.0|0.15|0.2|||Regression, Linear|||||.20|.15|<.001
71936590|NCT00415532|143393534|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.172|||<|0.0001||95.0|0.084|0.352||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.352|0.084|<0.0001
71936591|NCT00415532|143393535|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.307||||0.0005||95.0|0.154|0.611||Significant level is set at 0.05|Cochran-Mantel-Haenszel|||||0.611|0.154|0.0005
71936592|NCT00415532|143393538|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0133
71936593|NCT00415532|143393539|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3434||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.3434
71936594|NCT00415532|143393540|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0076||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0076
71936595|NCT00415532|143393541|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0246||||||Significant level is set at 0.05|Mixed Models Analysis|||||||0.0246
71936596|NCT01952574|143393551|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-1.12||||0.021|TWO_SIDED|95.0|-2.06|-0.17|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||-0.17|-2.06|0.021
71936597|NCT01952574|143393551|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-1.07|0.86|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||0.86|-1.07|0.83
71936598|NCT01952574|143393551|SUPERIORITY|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|0.11||||0.82|TWO_SIDED|92.0|-0.83|1.05|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||1.05|-0.83|0.82
71936599|NCT01952574|143393552|SUPERIORITY||Odds Ratio (OR)|2.0||||0.011|TWO_SIDED|95.0|1.17|3.42|||Generalised Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)||3.42|1.17|0.011
71936600|NCT01952574|143393552|SUPERIORITY||Odds Ratio (OR)|1.25||||0.44|TWO_SIDED|95.0|0.71|2.18|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)||2.18|0.71|0.44
71936601|NCT01952574|143393552|SUPERIORITY||Odds Ratio (OR)|0.93||||0.8|TWO_SIDED|95.0|0.53|1.63|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)||1.63|0.53|0.80
71692127|NCT01401543|142899284|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.91|||||TWO_SIDED|90.0|0.84|1.0|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.00|0.84|
71692128|NCT01401543|142899284|NON_INFERIORITY_OR_EQUIVALENCE|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.91|1.08|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.08|0.91|
71692129|NCT01401543|142899285|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.99|||||TWO_SIDED|90.0|0.93|1.05||||||||1.05|0.93|
71692130|NCT01401543|142899285|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.94|||||TWO_SIDED|90.0|0.89|1.0||||||||1.00|0.89|
71692131|NCT01401543|142899285|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
71692132|NCT01401543|142899285|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02||||||||1.02|0.90|
71692133|NCT01401543|142899285|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.97|||||TWO_SIDED|90.0|0.91|1.03||||||||1.03|0.91|
71692134|NCT01401543|142899285|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|1.01|||||TWO_SIDED|90.0|0.95|1.08||||||||1.08|0.95|
71692135|NCT01401543|142899286|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.72|||||TWO_SIDED|90.0|0.68|0.77|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.77|0.68|
71692136|NCT01401543|142899286|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.71|||||TWO_SIDED|90.0|0.66|0.76|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.76|0.66|
71692137|NCT01401543|142899286|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.92|1.05|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.05|0.92|
71692138|NCT01401543|142899286|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.69|||||TWO_SIDED|90.0|0.65|0.74|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||0.74|0.65|
71692139|NCT01401543|142899286|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.96|||||TWO_SIDED|90.0|0.9|1.02|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.02|0.90|
71692140|NCT01401543|142899286|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|0.98|||||TWO_SIDED|90.0|0.91|1.04|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.|||1.04|0.91|
71692141|NCT00520039|142899291|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.09|STANDARD_ERROR_OF_MEAN|0.94||0.02|TWO_SIDED|95.0|0.15|2.03|||Chi-squared|df = 1|The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.|Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.||2.03|0.15|0.02
71936602|NCT01952574|143393553|SUPERIORITY||LS Mean Difference|-0.4||||0.13|TWO_SIDED|95.0|-0.92|0.12|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.12|-0.92|0.13
71692142|NCT00520039|142899292|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.31|STANDARD_ERROR_OF_MEAN|1.31||0.32|TWO_SIDED|95.0|-1.0|1.62|||Chi-squared|df = 1|The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio|||1.62|-1.00|0.32
71692143|NCT00520039|142899293|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.25|STANDARD_ERROR_OF_MEAN|1.03||0.31|TWO_SIDED|95.0|-0.78|1.28|||Chi-squared|df = 1||||1.28|-0.78|.31
71692144|NCT00765817|142899307|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71692145|NCT00765817|142899308|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71692146|NCT00765817|142899309|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||||||<0.001
71692147|NCT00765817|142899310|SUPERIORITY_OR_OTHER|||||||0.174||95.0|||||ANCOVA|||||||0.174
71692148|NCT00765817|142899312|SUPERIORITY_OR_OTHER|||||||0.203||95.0|||||ANCOVA|||||||0.203
71692149|NCT00765817|142899313|SUPERIORITY_OR_OTHER|||||||0.063||95.0|||||ANCOVA|||||||0.063
71692150|NCT00765817|142899314|SUPERIORITY_OR_OTHER|||||||0.745||95.0|||||ANCOVA|||||||0.745
71692151|NCT00765817|142899315|SUPERIORITY_OR_OTHER|||||||0.933||95.0|||||ANCOVA|||||||0.933
71692152|NCT00765817|142899316|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71692153|NCT00765817|142899317|SUPERIORITY_OR_OTHER|||||||0.226||95.0|||||ANCOVA|||||||0.226
71692154|NCT00765817|142899318|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||||||0.026
71692155|NCT00765817|142899319|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANCOVA|||||||0.070
71692156|NCT00765817|142899320|SUPERIORITY_OR_OTHER|||||||0.011||95.0|||||ANCOVA|||||||0.011
71692157|NCT00765817|142899321|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANCOVA|||||||<0.001
71692158|NCT00765817|142899322|SUPERIORITY_OR_OTHER|||||||0.666||95.0|||||Negative binomial regression model|||||||0.666
71936603|NCT01952574|143393553|SUPERIORITY||LS Mean Difference|0.02||||0.95|TWO_SIDED|95.0|-0.51|0.54|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.54|-0.51|0.95
71936604|NCT01952574|143393553|SUPERIORITY||LS Mean Difference|0.37||||0.16|TWO_SIDED|95.0|-0.14|0.87|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.||||0.87|-0.14|0.16
71692159|NCT00765817|142899323|SUPERIORITY_OR_OTHER|||||||0.486||95.0|||||Fisher Exact|||||||0.486
71692160|NCT01043133|142899329|SUPERIORITY_OR_OTHER||log-binomial|3.97|STANDARD_ERROR_OF_MEAN|3.97||0.01|TWO_SIDED|95.0|1.34|11.79|||log-binomial regression||Robust Huber-White standard errors account for clustering|||11.79|1.34|.01
71692161|NCT01043133|142899330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.25|STANDARD_DEVIATION|2.78||0.05|TWO_SIDED|95.0|-2.48|-0.03|||ANCOVA|||||-.03|-2.48|.05
71692162|NCT01877668|142899386|SUPERIORITY_OR_OTHER||Risk Difference (RD)|17.13|STANDARD_ERROR_OF_MEAN|6.67||0.0102|TWO_SIDED|95.0|4.06|30.21|||Large sample approximation|Missing response (MR)=non-response (NR)||||30.21|4.06|0.0102
71692163|NCT01877668|142899386|SUPERIORITY_OR_OTHER||Risk Difference (RD)|27.24|STANDARD_ERROR_OF_MEAN|6.64|<|0.0001|TWO_SIDED|95.0|14.22|40.26|||Large sample approximation|MR=NR||||40.26|14.22|<0.0001
71692164|NCT01877668|142899386|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.55|STANDARD_ERROR_OF_MEAN|6.69||0.0055|TWO_SIDED|95.0|5.45|31.66|||Large sample approximation|MR=NR||||31.66|5.45|0.0055
71692165|NCT01877668|142899387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1697|STANDARD_ERROR_OF_MEAN|0.06173||0.0062|TWO_SIDED|95.0|-0.291|-0.0483|||Mixed Models Analysis|No imputation.||||-0.0483|-0.2910|0.0062
71692166|NCT01877668|142899387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2196|STANDARD_ERROR_OF_MEAN|0.06184||0.0004|TWO_SIDED|95.0|-0.3411|-0.098|||Mixed Models Analysis|No imputation.||||-0.0980|-0.3411|0.0004
71692167|NCT01877668|142899387|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2005|STANDARD_ERROR_OF_MEAN|0.06145||0.0012|TWO_SIDED|95.0|-0.3213|-0.0797|||Mixed Models Analysis|No imputation.||||-0.0797|-0.3213|0.0012
71692168|NCT00377637|142899444|SUPERIORITY_OR_OTHER|||||||0.478||95.0|||||Regression, Logistic|Covariates included Treatment, Race, Geographical Region, and WHO Lupus Nephritis Class V and specified interaction terms.||||||0.478
71692169|NCT00377637|142899445|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||Testing at the alpha=0.05 level was applied with no adjustments made for multiplicity.|Log Rank|||The difference in Kaplan-Meier survival curves between treatment groups (MMF-AZA) was assessed using a log-rank test, which is a non-parametric test to compare the survival distributions of two groups commonly used to analyze time-to-event endpoints.||||0.003
71692170|NCT01111565|142899463|SUPERIORITY||Treatment Difference|-5.4|||=|0.079|TWO_SIDED|95.0|-11.5|0.7|||ANCOVA|||||0.7|-11.5|=0.079
71692171|NCT01111565|142899463|SUPERIORITY||Treatment Difference|-5.2|||=|0.085|TWO_SIDED|95.0|-11.2|0.7|||ANCOVA|||||0.7|-11.2|=0.085
71692172|NCT01111565|142899464|SUPERIORITY||Treatment Difference|-0.5|||=|0.148|TWO_SIDED|95.0|-1.1|0.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.1|-1.1|=0.148
71692173|NCT01111565|142899464|SUPERIORITY||Treatment Difference|-0.4|||=|0.242|TWO_SIDED|95.0|-1.0|0.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Row Mean Scores Test was used to determine the p-value.||||0.3|-1.0|=0.242
71692174|NCT01111565|142899465|SUPERIORITY||Treatment Difference|0.1|||=|0.91|TWO_SIDED|95.0|-1.8|2.1|||ANCOVA|||||2.1|-1.8|=0.910
71692175|NCT01111565|142899465|SUPERIORITY||Treatment Difference|-1.0|||=|0.291|TWO_SIDED|95.0|-3.0|0.9|||ANCOVA|||||0.9|-3.0|=0.291
71692176|NCT00583908|142899470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.5|STANDARD_DEVIATION|17.1|<|0.0001||95.0||||Paired t-test|t-test, 1 sided||mean difference was senofilcon A minus balafilcon A|Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation||||<0.0001
71692177|NCT00583908|142899470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.4|STANDARD_DEVIATION|17.8||0.0002||95.0||||paired t-test|t-test, 1 sided||mean difference is senofilcon A minus lotrafilcon B|Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation||||0.0002
71692178|NCT00583908|142899470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.0|STANDARD_DEVIATION|12.4|<|0.0001||95.0||||paired t-test|t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation||||<0.0001
71692179|NCT00583908|142899471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.15||0.0083||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus balafilcon A|Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score||||0.0083
71692180|NCT00583908|142899471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_DEVIATION|0.09||0.052||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus lotrafilcon B|Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score||||0.052
71692181|NCT00583908|142899471|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13|STANDARD_DEVIATION|0.14||0.015||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score||||0.015
71692182|NCT00583908|142899472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|STANDARD_DEVIATION|6.5||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.16
71692183|NCT00583908|142899472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|3.5||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.73
71692184|NCT00583908|142899472|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3|STANDARD_DEVIATION|4.4||0.044||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|||||0.044
71692185|NCT00583908|142899473|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.1|STANDARD_DEVIATION|5.0||0.044||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.044
71692186|NCT00583908|142899473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4|STANDARD_DEVIATION|4.7||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
71692187|NCT00583908|142899473|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5|STANDARD_DEVIATION|5.9||0.44||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.44
71692188|NCT00583908|142899474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5|STANDARD_DEVIATION|6.5||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.78
71692189|NCT00583908|142899474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_DEVIATION|6.3||0.68||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.68
71692190|NCT00583908|142899474|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_DEVIATION|7.6||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.78
71692191|NCT00583908|142899475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.1|STANDARD_DEVIATION|6.5||0.11||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.11
71936605|NCT01335464|143393609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|125.26|STANDARD_ERROR_OF_MEAN|24.209|<|0.0001|TWO_SIDED|95.0|77.68|172.84||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix~Nintedanib 150 mg bid versus Placebo"|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||172.84|77.68|<0.0001
71936606|NCT01335464|143393610|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.248||0.9657|TWO_SIDED|95.0|-2.5|2.4|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||2.40|-2.50|0.9657
71692192|NCT00583908|142899475|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_DEVIATION|4.3||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.31
71692193|NCT00583908|142899475|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-3.0|STANDARD_DEVIATION|6.3||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.16
71692194|NCT00583908|142899476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.9|STANDARD_DEVIATION|6.8||0.061||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.061
71692195|NCT00583908|142899476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_DEVIATION|3.9||0.47||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.47
71692196|NCT00583908|142899476|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_DEVIATION|3.6||0.38||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.38
71692197|NCT00583908|142899477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_DEVIATION|3.5||0.17||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.17
71692198|NCT00583908|142899477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|5.0||0.89||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.89
71692199|NCT00583908|142899477|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1|STANDARD_DEVIATION|5.8||0.56||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.56
71692200|NCT00583908|142899478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.0|STANDARD_DEVIATION|6.8||0.008||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.0080
71692201|NCT00583908|142899478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_DEVIATION|3.1||0.0049||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B|||||0.0049
71692202|NCT00583908|142899478|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.4|STANDARD_DEVIATION|5.6||0.0058||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|||||0.0058
71692203|NCT00583908|142899479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.2|STANDARD_DEVIATION|3.7||0.27||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A|||||0.27
71692204|NCT00583908|142899479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_DEVIATION|6.0||0.85||95.0|||||t-test, 1 sided||Mean difference is senofilocon A minus lotrafilcon B|||||0.85
71692205|NCT00583908|142899479|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3|STANDARD_DEVIATION|2.6||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omifilcon A|||||0.73
71692206|NCT02258217|142899480|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.8|STANDARD_DEVIATION|3.03||0.003|TWO_SIDED|95.0|-2.9|-0.66|||Paired t-test, 2 sided|||"We compared the two ADL scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post ADL scores."||-0.66|-2.9|0.003
71692207|NCT02258217|142899481|EQUIVALENCE|"We created a difference in ADL score variable. This was calculated as follows:~ADL score (new relapse) - ADL score (after treatment of current relapse) This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|0.0|STANDARD_DEVIATION|3.09||0.99|TWO_SIDED|95.0|-1.22|1.22|||Paired t-test, 2 sided|||"We compared the two RSH scores measured in the same arm at different time points (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post RSH scores."||1.22|-1.22|0.99
71692208|NCT02258217|142899483|EQUIVALENCE|"We created a difference in PCS score variable. This was calculated as follows:~PCS score (new relapse) - PCS score (after treatment of current relapse). This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|-1.9|STANDARD_DEVIATION|4.42||0.03|TWO_SIDED|95.0|-3.67|-0.18|||Paired t-test, two sided|||"We compared the two PCS scores measured in the same arm at different timepoints (new \& after treatment).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0 We used the Paired t-test to compare the pre - post PCS scores."||-0.18|-3.67|0.03
71692209|NCT02258217|142899484|EQUIVALENCE|"We created a difference in MSIS physical score variable. This was calculated as follows:~MSIS physical score (new relapse) - MSIS physical score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|2.5||||0.19|TWO_SIDED||||||Wilcoxon Signed Rank test|||"We compared the two MSIS physical scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post MSIS physical scores."||||0.19
71692210|NCT02258217|142899485|EQUIVALENCE|"We created a difference in MSIS psychological score variable. This was calculated as follows:~MSIS psychological score (new relapse) - MSIS psychological score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Mean Difference (Final Values)|3.1|STANDARD_DEVIATION|6.3||0.01|TWO_SIDED|95.0|0.74|5.45|||Paired t-test, 2 sided|||"We compared the two MSIS psychological scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in means is = 0 Alternate Hypothesis = Difference in means is not = 0~We used the Paired t-test to compare the pre - post MSIS psychological scores."||5.45|0.74|0.01
71692211|NCT02258217|142899486|EQUIVALENCE|"We created a difference in EDSS score variable. This was calculated as follows:~EDSS score (new relapse) - EDSS score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.23|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the median difference in EDSS scores is 0.0 to 0.5|"We compared the two EDSS scores measured in the same arm at different timepoints (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post EDSS scores."||||0.23
71692212|NCT02258217|142899487|EQUIVALENCE|"We created a difference in SAGE score variable. This was calculated as follows:~SAGE score (new relapse) - SAGE score (after treatment of current relapse)~This difference score was tested for equivalence to 0 or not."|Median Difference (Final Values)|0.0||||0.44|TWO_SIDED||||||Wilcoxon Signed Rank test||The interquartile range for the difference in medians is -1 to 0.|"We compared the two SAGE scores measured in the same arm at different time points (new relapse \& after treatment of relapse).~Null Hypothesis = Difference in medians is = 0 Alternate Hypothesis = Difference in medians is not = 0~We used the Wilcoxon Signed rank test to compare the pre - post SAGE scores."||||0.44
71692213|NCT00447772|142899518|SUPERIORITY_OR_OTHER_LEGACY||Mean difference|-0.322|||=|0.2552|TWO_SIDED|95.0|-0.877|0.233|||ANCOVA||The comparative analysis is based on adjusted means data.|An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).||0.233|-0.877|=0.2552
71692214|NCT00875563|142899527|NON_INFERIORITY_OR_EQUIVALENCE|An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.||||||0.02|TWO_SIDED||||||Exact test for matched pairs|||Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.||||0.02
71936607|NCT01335464|143393611|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.15||||0.6728|TWO_SIDED|95.0|0.54|2.42|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard Ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||2.42|0.54|0.6728
71936608|NCT01335464|143393612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.93|STANDARD_ERROR_OF_MEAN|19.708|<|0.0001|TWO_SIDED|95.0|71.27|148.59|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.59|71.27|<0.0001
71936609|NCT01335464|143393613|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.02|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.54|5.5|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.50|2.54|<0.0001
71936610|NCT01335464|143393614|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.22|STANDARD_ERROR_OF_MEAN|0.564|<|0.0001|TWO_SIDED|95.0|2.11|4.33|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.33|2.11|<0.0001
71761111|NCT01039376|143023892|SUPERIORITY||Mean Difference (Final Values)|-2.19||||0.0199|TWO_SIDED|95.0|-4.04|-0.35||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Disease Effects Scale|||-0.35|-4.04|0.0199
71936611|NCT01335464|143393615|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|0.753|<|0.0001|TWO_SIDED|95.0|2.52|5.48|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.48|2.52|<0.0001
71936612|NCT01335464|143393618|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.914||||0.0007|TWO_SIDED|95.0|1.32|2.79|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.79|1.32|0.0007
71936613|NCT01335464|143393619|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.847||||0.001|TWO_SIDED|95.0|1.28|2.66|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||2.66|1.28|0.0010
71936614|NCT01335464|143393620|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.4298|TWO_SIDED|95.0|0.55|1.29|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||1.29|0.55|0.4298
71936615|NCT01335464|143393621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.32|STANDARD_ERROR_OF_MEAN|1.744||0.1832|TWO_SIDED|95.0|-5.74|1.1|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.10|-5.74|0.1832
71936616|NCT01335464|143393622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.86|STANDARD_ERROR_OF_MEAN|1.446||0.551|TWO_SIDED|95.0|-1.97|3.7|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ Impact component-by-visit and random effect for patient||3.70|-1.97|0.5510
71936617|NCT01335464|143393623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.19|STANDARD_ERROR_OF_MEAN|1.427||0.4049|TWO_SIDED|95.0|-3.99|1.61|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||1.61|-3.99|0.4049
71936618|NCT01335464|143393624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78|STANDARD_ERROR_OF_MEAN|1.289||0.5446|TWO_SIDED|95.0|-3.31|1.75|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||1.75|-3.31|0.5446
71936619|NCT01335464|143393625|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88|STANDARD_ERROR_OF_MEAN|1.77||0.6203|TWO_SIDED|95.0|-4.35|2.6|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||2.60|-4.35|0.6203
71936620|NCT01335464|143393626|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|1.803||0.8942|TWO_SIDED|95.0|-3.78|3.3|||Mixed Models Analysis||"Within- patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||3.30|-3.78|0.8942
71936621|NCT01335464|143393627|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.64|STANDARD_ERROR_OF_MEAN|1.596||0.3042|TWO_SIDED|95.0|-1.49|4.77|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.77|-1.49|0.3042
71936622|NCT01335464|143393628|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.276||||0.1818|TWO_SIDED|95.0|0.89|1.83|||Regression, Logistic||Nintedanib 150mg versus placebo|Logistic regression with term treatment||1.83|0.89|0.1818
71936623|NCT01335464|143393630|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.17||||0.6793|TWO_SIDED|95.0|0.56|2.46|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150mg bid versus placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||2.46|0.56|0.6793
71936624|NCT01335464|143393631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63||||0.288|TWO_SIDED|95.0|0.29|1.36|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.36|0.29|0.2880
71936625|NCT01335464|143393632|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.61||||0.3515|TWO_SIDED|95.0|0.25|1.47|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.47|0.25|0.3515
71936626|NCT01335464|143393633|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.4869|TWO_SIDED|95.0|0.26|1.82|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height||1.82|0.26|0.4869
71936627|NCT01335464|143393634|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.443|TWO_SIDED|95.0|0.36|1.51|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.51|0.36|0.4430
71936628|NCT01335464|143393635|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.3558|TWO_SIDED|95.0|0.52|1.25|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height||1.25|0.52|0.3558
71936629|NCT01335464|143393636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.181||0.1138|TWO_SIDED|95.0|-0.07|0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.64|-0.07|0.1138
71936630|NCT01335464|143393637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.015|STANDARD_ERROR_OF_MEAN|0.0896||0.865|TWO_SIDED|95.0|-0.191|0.161|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.161|-0.191|0.8650
71936631|NCT01227668|143393670|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.57||||0.097|TWO_SIDED|95.0|0.28|1.12|||Stratified log rank|||||1.12|0.28|0.097
71936632|NCT01227668|143393671|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4||||0.051|TWO_SIDED|95.0|-8.82|0.02||For secondary endpoints, hierarchical testing aimed to keep the overall experiment-wise type I error rate to \<=0.05. Difference in chg from BL was tested at 0.05 significance only if APR arm significantly differed vs placebo from primary analysis.|ANCOVA|||||0.02|-8.82|0.051
71936633|NCT01227668|143393672|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.09|TWO_SIDED|95.0|-1.3|0.1||Treatment diff in chg from BL to endpnt in IS score was tested at 0.05 signif only if ARP arm signif differed vs pb from PA. Thus, if ARP arm signif differed vs pb in IS score, treatment diff in mean CGI-I score at endpnt was tested at 0.05 signfnce.|ANCOVA|||||0.1|-1.3|0.090
71936634|NCT01033864|143393675|SUPERIORITY_OR_OTHER|||||||0.8055|||||||Wilcoxon (Mann-Whitney)|||||||0.8055
71936635|NCT01033864|143393676|SUPERIORITY_OR_OTHER|||||||0.2548|||||||Wilcoxon (Mann-Whitney)|||||||0.2548
71936636|NCT01033864|143393677|SUPERIORITY_OR_OTHER|||||||0.4417|||||||Wilcoxon (Mann-Whitney)|||||||0.4417
71936637|NCT01033864|143393678|SUPERIORITY_OR_OTHER|||||||0.0455|||||||Wilcoxon (Mann-Whitney)|||||||0.0455
71936638|NCT01033864|143393679|SUPERIORITY_OR_OTHER|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||||||0.2300
71936639|NCT01033864|143393680|SUPERIORITY_OR_OTHER|||||||0.0106|||||||Wilcoxon (Mann-Whitney)|||||||0.0106
71936640|NCT01033864|143393681|SUPERIORITY_OR_OTHER|||||||0.3401|||||||Wilcoxon (Mann-Whitney)|||||||0.3401
71936641|NCT01033864|143393682|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||||||0.0074
71936642|NCT01033864|143393683|SUPERIORITY_OR_OTHER|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||||||0.0002
71936643|NCT01709383|143393685|SUPERIORITY_OR_OTHER|||||||0.57|||||||Mixed Models Analysis|||||||.57
71936644|NCT01709383|143393687|SUPERIORITY_OR_OTHER|||||||0.64|||||||Mixed Models Analysis|||||||.64
71936645|NCT02668302|143393705|SUPERIORITY|||||||0.4709|||||||t-test, 2 sided|P-values from two-sample T-test with equal variance assumption||||||0.4709
71936646|NCT00982410|143393747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6489|STANDARD_ERROR_OF_MEAN|0.29|<|0.05|TWO_SIDED|95.0|-1.2255|-0.0722|||Mixed Models Analysis|Adjusted for baseline NRS-1 pain level. Time interval and therapy session block were utilized to model the variance.|EUC (Arm 2) was referent. Estimation parameter = value for Cognitive Behavior Treatment group minus value for Educational Support group.|Ho: There was no difference in average pain level across the follow-up period, between CBT group and Educational support group.||-0.07220|-1.2255|<0.05
71936647|NCT00982410|143393748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|||<|0.05|TWO_SIDED|95.0|0.034|0.466|||Mixed Models Analysis|Adjusted for baseline WHY MPI General Activity score. Time interval and therapy session block were utilized to model the variance.|Education Support group was referent. Mean difference = value for CBT group minus value for Educational Support group.|||0.466|0.034|<0.05
71936648|NCT00982410|143393749|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days of alcohol use. Time interval and therapy session block were utilized to model the variance.||||||<0.01
71936649|NCT00982410|143393750|SUPERIORITY_OR_OTHER||||||>|0.05|TWO_SIDED||||||Mixed Models Analysis|Adjusted for baseline #days illicit drug use. Time interval and therapy session block were utilized to model the variance. EUC group was referent.||||||>0.05
71936650|NCT00982410|143393751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.66|||>|0.05|TWO_SIDED|95.0|-5.0|14.32|||Mixed Models Analysis|Adjusted for baseline pain tolerance. Time interval and therapy session block were utilized to model the variance.|Educational Support group = referent. Estimation parameter = CBT group minus EUC group, adjusted for BL pain tolerance. Cold tolerance distribution had ceiling and floor effects; and, \~20% of participants refused cold tolerance task in follow-up.|||14.32|-5.00|>0.05
71936651|NCT00982410|143393752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.28|||<|0.005|TWO_SIDED|95.0|3.93|16.63|||Mixed Models Analysis|Adjusted for baseline CPSS PSE score. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|Adjusted for baseline CPSS PSE score. EUC group was referent. Mean difference = value for CBT minus value for Educational Support group.|||16.63|3.93|<0.005
71936652|NCT04014959|143393776|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -4.47||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
71936653|NCT04014959|143393776|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -3.00||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Pre-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
71936654|NCT04014959|143393776|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|t(35)= -2.96||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Pre-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||0.005
71692215|NCT03257436|142899537|OTHER|"A power calculation using a sample size of 61 subjects as the non-responders with the LV MSP on was calculated based on a one-sided exact test for a single binomial proportion, using SAS Version 9.4 with the following assumptions:~* Performance goal = 90%~* Expected LV MSP feature-related CFR rate between 6 and 12 Month Visit = 98%~* Significance level = 5%~* Power = 80%"|Kaplan Meir Methodology|99.0|||||ONE_SIDED|95.0|94.1|||||||"The LV MSP feature-related CFR between the 6 Month Visit and the 12 Month Visit was calculated using Kaplan-Meier methodology.~H0: LV MSP feature-related complication-free rate between 6 Month Visit and 12 Month Visit ≤ 90%.~The sample size of 61 subjects was required to evaluate the Primary Safety Endpoint using an exact test since a power calculation cannot be directly calculated for a one group Kaplan-Meier analysis."|||94.1|
71692216|NCT03257436|142899538|OTHER|Even though fewer subjects (78) were available for the effectiveness endpoint analysis than originally planned (110), the study was still powered at approximately 90%|Proportion|51.3|||||ONE_SIDED|95.0|41.1|||||||"The effectiveness endpoint for SMART MSP PAS is the proportion of the LV MSP Group with an Improved CCS. For this endpoint, those subjects in the LV MSP Group that become responders will be defined as having an Improved CCS.~H0: Proportion of LV MSP Group subjects with Improved CCS from 6 Month Visit through 12 Month Visit ≤ 5%"|||41.1|
71692217|NCT01305811|142899539|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||general estimating equations|||||||0.03
71692218|NCT01305811|142899540|SUPERIORITY_OR_OTHER||||||=|0.22|TWO_SIDED||||||t-test, 2 sided|||In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student's t-tests at an alpha=0.05.||||=0.22
71692219|NCT03064113|142899541|SUPERIORITY||Difference of LS Mean|173.8|||<|0.001|TWO_SIDED|95.0|112.4|235.3|||t-test, 2 sided|||||235.3|112.4|<0.001
71692220|NCT03064113|142899541|SUPERIORITY||Difference of LS Mean|169.3|||<|0.001|TWO_SIDED|95.0|107.8|230.8|||t-test, 2 sided|||||230.8|107.8|<0.001
71692221|NCT03064113|142899541|SUPERIORITY||Difference of LS Mean|175.6|||<|0.001|TWO_SIDED|95.0|114.1|237.2|||t-test, 2 sided|||||237.2|114.1|<0.001
71692222|NCT03064113|142899542|SUPERIORITY||Slope|112.5||||0.001|TWO_SIDED|95.0|44.5|180.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||180.5|44.5|0.001
71936655|NCT04014959|143393776|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|t(35)= -5.05||Statistical analysis of fMRI-guided TMS evoked subgenual anterior cingulate responses (fMRI BOLD) change at Post-tx/Post-iTBS. Statistics are from one-sample T-tests vs. 0, 2-tailed. Negative t-values represent negative mean fMRI BOLD percent signal change. Alternative hypothesis: true mean is not equal to 0.||||<0.001
71936656|NCT04014959|143393778|OTHER|Statistics are an unadjusted linear regression of change in DASS-21 depression score on the pre-intervention TMS/fMRI evoked brain response.||||||0.007|||||||Regression, Linear|β = -33.60||Analysis to investigate the correlation between changes in DASS-21 Scores (Secondary Outcome) and Evoked Functional Brain Activity (Other Pre-specified Outcome) pre and post the 3-Day TMS Intervention Regimen.||||0.007
71936657|NCT01016652|143393779|NON_INFERIORITY_OR_EQUIVALENCE|This is a non-inferiority analysis, with \>=5 CLUE points being the non-inferiority margin.|Mean Difference (Final Values)|-4.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-9.86|1.59|||Mixed Models Analysis|||"Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense."||1.59|-9.86|
71936658|NCT01016652|143393780|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin will be exceeded if the test lens is greater than or equal to 0.25D over the control lens.|Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.06|||TWO_SIDED|95.0|-0.09|0.1|||Mixed Models Analysis|||"Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens"||0.10|-0.09|
71936659|NCT02060461|143393785|OTHER|||||||0.003|||||||t-test, 2 sided|||Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetry||||.003
71936660|NCT02034799|143393786|NON_INFERIORITY_OR_EQUIVALENCE|The assumed proportion of success for SOC is 0.95 and the proportion of success for the Bioseal group at which the power is calculated is 0.95. A sample size of 112 subjects per group achieves 80% power to detect the non-inferiority margin difference between the group proportions of -0.10. One-sided significance level of 0.025 was used. Using drop-out rate of 10%, 125 subjects per treatment group were randomized for a total of 250 subjects.|Risk Difference (RD)|0.0781|||||TWO_SIDED|95.0|-0.048|0.199||||||H0: Delta \</= -0.1 HA: Delta \> -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application||0.199|-0.048|
71936661|NCT01133821|143393795|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||time effect for HRSD-17||||<0.0001
71936662|NCT01133821|143393796|SUPERIORITY||||||>|0.05|||||||Regression, Linear|Adjusted for baseline scores||||||>0.05
71936663|NCT03273387|143393845|SUPERIORITY|||||||0.008||||||95% Confidence interval 1.97 - 11.3 statistical significant if p\<0.05|t-test, 2 sided|t=2.988 df=18||||||0.008
71936664|NCT03273387|143393846|SUPERIORITY|||||||0.33||||||statistical significant if p \<0.05|two-way ANOVA|DF=3||||||0.33
71936665|NCT03273387|143393847|SUPERIORITY|||||||0.0002||||||95% Confidence interval 15.92 to 42.53 statistical significant if p \<0.05|t-test, 2 sided|t=4.598 df=19||||||0.0002
71936666|NCT01907087|143393848|OTHER|Inference is by an exact binomial test of the null hypothesis H0: Prob(response) \<= 0.50 vs. the alternative hypothesis H1: Prob(response) \> 0.50, where Prob(response) denotes the population probability of a response. The confidence interval is an exact interval with significance level α=0.05.|Proportion of responders|0.87||||0.0002|TWO_SIDED|95.0|0.66|0.97|||exact binomial test|||"Responder Analysis using ITT Population: Proportion of Subjects without an Unreversed Two-point Decline or Score of 0 in ML Scale Score at 48 Weeks.~A 'response' is defined as the absence of an unreversed two-point decline or score of 0 in the 0-to-6 point CLN2 score at 48 weeks."||0.97|0.66|0.0002
71936667|NCT01907087|143393848|OTHER|"Subject rate of decline per 48 weeks is estimated: (baseline CLN2 score - last CLN2 score)/(time elapsed in units of 48 weeks).~P-value computed as a two-sided t-test for the hypothesis H0: Rate=2.0 points lost/48 weeks vs. H1: Rate not equal 2.0 points lost/48 weeks."|Slope|0.4|STANDARD_DEVIATION|0.809|<|0.0001|TWO_SIDED|95.0|0.05|0.75|||t-test, 2 sided|||Slopes Analysis using ITT Population: Estimated Rate of Decline (300 mg Dosing Period).||0.75|0.05|<0.0001
71936668|NCT02180061|143393858|SUPERIORITY|||||||0.0216||||||One-sided p-value. The ORR was deemed clinically meaningful if the lower bound of the 95% confidence interval exceeded 10% (p\<0.0250).|Exact Binomial Distribution|||||||0.0216
71936669|NCT00789802|143393877|SUPERIORITY_OR_OTHER|||||||0.03|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.03
71936670|NCT00789802|143393877|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||.02
71936671|NCT02410252|143393883|OTHER||%|100.0|||||TWO_SIDED|||||There was no statistical analysis conducted on demographic characteristics or baseline surveys|descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses.||||
71936672|NCT02410252|143393883|OTHER|Only percents were calculated, no formal statistical analysis was completed.||||||||||||Statistical analysis was not completed. This was a feasibility study with small n and was not powered to determine statistical significance.||||Only percent will be calculated. No statistical analysis will be conducted.|No statistical analysis was conducted as part of this study.|||
71936673|NCT02410252|143393884|OTHER||%|0.29||||0.13|TWO_SIDED|||||Significance was set at p\<0.05|Cochran-Mantel-Haenszel|||"GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran's Q test."||||0.13
71936674|NCT02410252|143393885|OTHER||%|84.0||||0.05|TWO_SIDED||||||descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study||||0.05
71936675|NCT00387712|143393893|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.001||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the primary outcome category (peak fitness) using repeated measures analysis of variance. No adjustment for multiple comparisons is needed.|ANOVA|No other adjustments such as degrees of freedom was necessary.||"Power Calculation: It was calculated that 29 subjects should be randomized to 2 groups to achieve a significant time by group interaction for peak fitness for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.~Primary analyses is a group by time analysis of variance in peak fitness levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points."||||0.001
71936676|NCT00387712|143393894|OTHER|Primary analyses is a group by time analysis of variance in myosin heavy chain levels levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||||0.11|||||||ANOVA|||Power Calculation: It was calculated that 22 participants should be randomized to 2 groups to achieve a significant time by group interaction for myosin heavy chain isoforms for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.||||0.11
71936677|NCT00387712|143393895|OTHER|Analysis of variance between groups across time is the primary analyses.||||||0.81||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the secondary outcome category (30 ft walk time - fastest comfortable gait) using repeated measures analysis of variance.|ANOVA|No other adjustments such as degrees of freedom was necessary.||Primary analyses is a group by time analysis of variance in 30 foot walk time (sec) between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||0.81
71936678|NCT00322309|143393901|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|2.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that there would be no significant difference between the two treatment groups for benzoylecgonine data collected for Week 11.||||>0.05
71936679|NCT00322309|143393902|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.8|STANDARD_DEVIATION|6.6|>|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||It was hypothesized that means scores for the CGI-O would not differ significantly for these values obtained in the final treatment week, Week 11.||||>0.05
71936680|NCT00322309|143393903|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_DEVIATION|5.4|>|0.05|TWO_SIDED|||||This analysis involves a between group comparison.|t-test, 2 sided|||It hypothesized that the two treatment groups would not differ significantly with respect to the total HAM-D scores obtained in the final week of the study (Week 11).||||>0.05
71692223|NCT03064113|142899542|SUPERIORITY||Difference of LS Mean|123.4|||<|0.001|TWO_SIDED|95.0|54.6|192.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||192.3|54.6|<0.001
71936681|NCT00322309|143393904|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|18.0|>|0.05||95.0||||Percent of capsules administered does not differ significantly between the two groups.|t-test, 2 sided|||It was hypothesized that there would be no significant difference in the mean percentage of capsules of those dispensed between the two groups.||||>0.05
71936682|NCT00322309|143393905|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_DEVIATION|8.5|>|0.05||95.0|||||t-test, 2 sided|||It was hypothesized that there would not be a significant difference between the two groups in the mean percent of urines positive for riboflavin.||||>0.05
71936683|NCT01772368|143393909|OTHER|linearity statistical test|||||<|0.0001||||||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.||A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.||||<0.0001
71936684|NCT01772368|143393909|SUPERIORITY||LSM difference|251.3|||<|0.0001|TWO_SIDED|95.0|215.6|287.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||287.1|215.6|<0.0001
71692224|NCT03064113|142899542|SUPERIORITY||Difference of LS Mean|15.3||||0.659|TWO_SIDED|95.0|-53.5|94.1|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr||94.1|-53.5|0.659
71692225|NCT03064113|142899542|SUPERIORITY||Difference of LS Mean|102.8|||<|0.001|TWO_SIDED|95.0|54.1|151.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||151.5|54.1|<0.001
71692226|NCT03064113|142899542|SUPERIORITY||Difference of LS Mean|136.6|||<|0.001|TWO_SIDED|95.0|87.8|185.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr||185.3|87.8|<0.001
71692227|NCT03064113|142899542|SUPERIORITY|Tx Difference of LS Mean FEV1 at 24 hr|Difference of LS Mean|-24.2||||0.327|TWO_SIDED|95.0|-72.9|24.6|||t-test, 2 sided|||||24.6|-72.9|0.327
71936685|NCT01772368|143393909|SUPERIORITY||LSM difference|227.56|||<|0.0001|TWO_SIDED|95.0|191.6|263.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||263.5|191.6|<0.0001
71692228|NCT03064113|142899543|SUPERIORITY||Difference of LS Mean|26.4|||<|0.001|TWO_SIDED|95.0|18.0|34.8|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||34.8|18.0|<0.001
71692229|NCT03064113|142899543|SUPERIORITY||Difference of LS Mean|29.1|||<|0.001|TWO_SIDED|95.0|20.8|37.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||37.4|20.8|<0.001
71936686|NCT01772368|143393909|SUPERIORITY||LSM difference|196.85|||<|0.0001|TWO_SIDED|95.0|161.2|232.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||232.5|161.2|<0.0001
71936687|NCT01772368|143393909|SUPERIORITY||LSM difference|151.71|||<|0.0001|TWO_SIDED|95.0|115.9|187.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||187.5|115.9|<0.0001
71692230|NCT03064113|142899543|SUPERIORITY||Difference of LS Mean|25.6|||<|0.001|TWO_SIDED|95.0|17.3|33.9|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs||33.9|17.3|<0.001
71692231|NCT03064113|142899543|SUPERIORITY||Difference of LS Mean|20.1|||<|0.001|TWO_SIDED|95.0|12.1|28.2|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||28.2|12.1|<0.001
71692232|NCT03064113|142899543|SUPERIORITY||Difference of LS Mean|25.4|||<|0.001|TWO_SIDED|95.0|17.4|33.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs||33.4|17.4|<0.001
71936688|NCT01772368|143393909|SUPERIORITY||LSM difference|193.42|||<|0.0001|TWO_SIDED|95.0|157.4|229.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100|The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||229.5|157.4|<0.0001
71692233|NCT03064113|142899543|SUPERIORITY||Difference of LS Mean|10.6||||0.01|TWO_SIDED|95.0|2.5|18.6|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hr||18.6|2.5|0.010
71692234|NCT03064113|142899544|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
71692235|NCT03064113|142899544|SUPERIORITY||Difference of LS Mean|0.1||||0.046|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.046
71692236|NCT03064113|142899544|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.003
71692237|NCT03064113|142899544|SUPERIORITY||Difference of LS Mean|0.1||||0.003|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.003
71692238|NCT03064113|142899544|SUPERIORITY||Difference of LS Mean|0.1||||0.048|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.048
71692239|NCT03064113|142899544|SUPERIORITY||Difference of LS Mean|0.1||||0.007|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.2|0.0|0.007
71936689|NCT01772368|143393909|SUPERIORITY||LSM difference|57.88||||0.0017|TWO_SIDED|95.0|22.0|93.7||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||93.7|22.0|0.0017
71936690|NCT01772368|143393909|SUPERIORITY||LSM difference|34.14||||0.0624|TWO_SIDED|95.0|-1.8|70.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||70.1|-1.8|0.0624
71936691|NCT01772368|143393909|SUPERIORITY||LSM difference|3.42||||0.8503|TWO_SIDED|95.0|-32.3|39.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||39.1|-32.3|0.8503
71936692|NCT01772368|143393909|SUPERIORITY||LSM difference|-41.72||||0.0229|TWO_SIDED|95.0|-77.6|-5.8||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-5.8|-77.6|0.0229
71936693|NCT01772368|143393909|SUPERIORITY||LSM difference|-193.42|||<|0.0001|TWO_SIDED|95.0|-229.5|-157.4||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-157.4|-229.5|<0.0001
71936694|NCT01772368|143393910|SUPERIORITY||LSM difference|226.77|||<|0.0001|TWO_SIDED|95.0|172.4|281.1||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||281.1|172.4|<0.0001
71936695|NCT01772368|143393910|SUPERIORITY||LSM difference|198.32|||<|0.0001|TWO_SIDED|95.0|143.7|252.9||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||252.9|143.7|<0.0001
71936696|NCT01772368|143393910|SUPERIORITY||LSM difference|158.99|||<|0.0001|TWO_SIDED|95.0|104.7|213.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.3|104.7|<0.0001
71936697|NCT01772368|143393910|SUPERIORITY||LSM difference|116.96|||<|0.0001|TWO_SIDED|95.0|62.4|171.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||171.6|62.4|<0.0001
71936698|NCT01772368|143393910|SUPERIORITY||LSM difference|159.01|||<|0.0001|TWO_SIDED|95.0|104.3|213.7||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||213.7|104.3|<0.0001
71936699|NCT01772368|143393910|SUPERIORITY||LSM difference|67.76||||0.015|TWO_SIDED|95.0|13.3|122.2||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||122.2|13.3|0.0150
71936700|NCT01772368|143393910|SUPERIORITY||LSM difference|39.31||||0.1578|TWO_SIDED|95.0|-15.3|94.0||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||94.0|-15.3|0.1578
71936701|NCT01772368|143393910|SUPERIORITY||LSM difference|-0.02||||0.9993|TWO_SIDED|95.0|-54.4|54.4||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||54.4|-54.4|0.9993
71936702|NCT01772368|143393910|SUPERIORITY||LSM difference|-42.05||||0.1311|TWO_SIDED|95.0|-96.7|12.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||12.6|-96.7|0.1311
71936703|NCT01772368|143393910|SUPERIORITY||LSM difference|-159.01|||<|0.0001|TWO_SIDED|95.0|-213.7|-104.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.||-104.3|-213.7|<0.0001
71936704|NCT01772368|143393911|SUPERIORITY||geometric mean ratio|1.929|||||TWO_SIDED|90.0|1.69|2.202||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||2.202|1.690|
71936705|NCT01772368|143393911|SUPERIORITY||geometric mean ratio|0.8|||||TWO_SIDED|90.0|0.702|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.911|0.702|
71936706|NCT01772368|143393911|SUPERIORITY||geometric mean ratio|0.427|||||TWO_SIDED|90.0|0.376|0.485||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.485|0.376|
71936707|NCT01772368|143393911|SUPERIORITY||LSM difference|0.172|||||TWO_SIDED|90.0|0.151|0.196||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.196|0.151|
71936708|NCT01772368|143393912|SUPERIORITY||geometric mean ratio|3.622|||||TWO_SIDED|90.0|3.149|4.168||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58||4.168|3.149|
71936709|NCT01772368|143393912|SUPERIORITY||geometric mean ratio|1.534|||||TWO_SIDED|90.0|1.335|1.763||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||1.763|1.335|
71936710|NCT01772368|143393912|SUPERIORITY||geometric mean ratio|0.795|||||TWO_SIDED|90.0|0.694|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61||0.911|0.694|
71936711|NCT01772368|143393912|SUPERIORITY||geometric mean ratio|0.339|||||TWO_SIDED|90.0|0.295|0.39||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59||0.390|0.295|
71936712|NCT02449291|143393920|SUPERIORITY|||||||0.016|ONE_SIDED|95.0||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.016) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
71936713|NCT02449291|143393920|SUPERIORITY|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.015) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.||||0.016
71936714|NCT02449291|143393921|SUPERIORITY|||||||0.009||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.009
71936715|NCT02449291|143393921|SUPERIORITY|||||||0.002||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.002
71936716|NCT02449291|143393922|SUPERIORITY|||||||0.17||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.170
71692240|NCT03064113|142899545|SUPERIORITY||Difference of LS Mean|0.1||||0.054|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.054
71692241|NCT03064113|142899545|SUPERIORITY||Difference of LS Mean|0.1||||0.045|TWO_SIDED|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.2|0.0|0.045
71692242|NCT03064113|142899545|SUPERIORITY||Difference of LS Mean|0.0||||0.503|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr||0.1|-0.0|0.503
71936717|NCT02449291|143393922|SUPERIORITY|||||||0.552||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared|||||||0.552
71936718|NCT02449291|143393923|SUPERIORITY|||||||0.003|||||||Regression, Cox|||||||0.003
71936719|NCT02449291|143393923|SUPERIORITY||||||<|0.001|||||||Regression, Cox|||||||<0.001
71936720|NCT02449291|143393924|SUPERIORITY|||||||0.209|||||||Chi-squared|||||||0.209
71936721|NCT02449291|143393924|SUPERIORITY|||||||0.44|||||||Chi-squared|||||||0.440
71936722|NCT02449291|143393925|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71936723|NCT02449291|143393925|SUPERIORITY|||||||0.009|||||||Chi-squared|||||||0.009
71936724|NCT02449291|143393926|SUPERIORITY|||||||0.115|||||||Chi-squared|||||||0.115
71936725|NCT02449291|143393926|SUPERIORITY|||||||0.222|||||||Chi-squared|||||||0.222
71936726|NCT02449291|143393927|SUPERIORITY|||||||0.474|||||||Chi-squared|||||||0.474
71936727|NCT02449291|143393927|SUPERIORITY|||||||0.505|||||||Chi-squared|||||||0.505
71936728|NCT02449291|143393928|SUPERIORITY|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||||||0.103
71936729|NCT02449291|143393928|SUPERIORITY|||||||0.166|||||||Wilcoxon (Mann-Whitney)|||||||0.166
71936730|NCT02449291|143393929|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||||||0.06
71692243|NCT03064113|142899545|SUPERIORITY||Difference of LS Mean|0.0||||0.183|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.183
71692244|NCT03064113|142899545|SUPERIORITY||Difference of LS Mean|0.0||||0.422|TWO_SIDED|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.1|-0.0|0.422
71936731|NCT02449291|143393929|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71936732|NCT03551730|143393930|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71936733|NCT03551730|143393930|SUPERIORITY||Least Squares Means (Difference)|-0.2|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71936734|NCT03551730|143393930|SUPERIORITY||Least Squares Means (Difference)|-0.23|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71936735|NCT03551730|143393931|SUPERIORITY||Least Squares Means (Difference)|53922.58||||0.1529|TWO_SIDED||||||ANCOVA|||||||0.1529
71936736|NCT03551730|143393931|SUPERIORITY||Least Squares Means (Difference)|124993.1|||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71936737|NCT03551730|143393931|SUPERIORITY||Least Squares Means (Difference)|96385.09||||0.0032|TWO_SIDED||||||ANCOVA|||||||0.0032
71936738|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.74|||||ONE_SIDED||||||||GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"||||
71936739|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.76|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936740|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.15|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936741|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936742|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.52|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936743|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936744|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|2.48|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936745|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.0|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936746|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI GMT ratio|1.23|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71692245|NCT03064113|142899545|SUPERIORITY||Difference of LS Mean|0.0||||0.287|TWO_SIDED|95.0|-0.1|0.0|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr||0.0|-0.1|0.287
71692246|NCT03064113|142899547|SUPERIORITY||Difference of LS Mean|3975.5|||<|0.001|TWO_SIDED|95.0|2007.3|5943.7|||t-test, 2 sided|||||5943.7|2007.3|<0.001
71692247|NCT03064113|142899547|SUPERIORITY||Difference of LS Mean|5888.9|||<|0.001|TWO_SIDED|95.0|3924.4|7853.4|||t-test, 2 sided|||||7853.4|3924.4|<0.001
71692248|NCT03064113|142899547|SUPERIORITY||Difference of LS Mean|2654.7||||0.009|TWO_SIDED|95.0|689.7|4619.6|||t-test, 2 sided|||||4619.6|689.7|0.009
71692249|NCT03990051|142899559|SUPERIORITY|Comparison of changes in score from baseline, Active - Placebo.||||||0.0197|||||||Mixed Models Analysis|||||||0.0197
71692250|NCT03990051|142899560|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0039|||||||Mixed Models Analysis|||||||0.0039
71692251|NCT03990051|142899561|SUPERIORITY|Comparison of changes in score from baseline.|||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71936747|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.12|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71692252|NCT03990051|142899562|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0002|||||||ANCOVA|||||||0.0002
71692253|NCT03990051|142899563|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0138|||||||Mixed Models Analysis|||||||0.0138
71692254|NCT03990051|142899564|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0014|||||||Mixed Models Analysis|||||||0.0014
71692255|NCT03990051|142899565|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0849|||||||Mixed Models Analysis|||||||0.0849
71692256|NCT03990051|142899566|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0041|||||||Mixed Models Analysis|||||||0.0041
71692257|NCT03990051|142899567|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0006|||||||Mixed Models Analysis|||||||0.0006
71692258|NCT03990051|142899568|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0143|||||||Mixed Models Analysis|||||||0.0143
71692259|NCT03990051|142899569|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0398|||||||Mixed Models Analysis|||||||0.0398
71692260|NCT03990051|142899570|SUPERIORITY|Comparison of changes in score from baseline.||||||-3.97|||||||Mixed Models Analysis|||||||-3.97
71692261|NCT03990051|142899571|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71692262|NCT03990051|142899572|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0005|||||||Mixed Models Analysis|||||||0.0005
71692263|NCT03990051|142899573|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
71692264|NCT03990051|142899574|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0636|||||||Mixed Models Analysis|||||||0.0636
71692265|NCT03990051|142899575|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0028|||||||Mixed Models Analysis|||||||0.0028
71692266|NCT03990051|142899576|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0067|||||||Mixed Models Analysis|||||||0.0067
71692267|NCT03990051|142899577|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0105|||||||Mixed Models Analysis|||||||0.0105
71692268|NCT03990051|142899578|SUPERIORITY|Comparison of changes in score from baseline.||||||0.001|||||||Mixed Models Analysis|||||||0.0010
71692269|NCT03990051|142899579|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0155|||||||Mixed Models Analysis|||||||0.0155
71692270|NCT03990051|142899580|SUPERIORITY|Comparison of changes in score from baseline.||||||0.016|||||||Mixed Models Analysis|||||||0.0160
71692271|NCT03990051|142899581|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0117|||||||Mixed Models Analysis|||||||0.0117
71692272|NCT03990051|142899582|SUPERIORITY|Comparison of changes in score from baseline.||||||0.4649|||||||Mixed Models Analysis|||||||0.4649
71692273|NCT03990051|142899583|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0082|||||||Mixed Models Analysis|||||||0.0082
71692274|NCT03990051|142899584|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0225|||||||Mixed Models Analysis|||||||0.0225
71692275|NCT03990051|142899585|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1822|||||||Mixed Models Analysis|||||||0.1822
71692276|NCT03990051|142899586|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0515|||||||Mixed Models Analysis|||||||0.0515
71692277|NCT03990051|142899587|SUPERIORITY|Comparison of changes in score from baseline.||||||0.044|||||||Mixed Models Analysis|||||||0.044
71692278|NCT03990051|142899588|SUPERIORITY|Comparison of changes of score from baseline.||||||0.083|||||||Mixed Models Analysis|||||||0.083
71692279|NCT03990051|142899589|SUPERIORITY|Comparison of changes in score from baseline.||||||0.7147|||||||Mixed Models Analysis|||||||0.7147
71692280|NCT03990051|142899590|SUPERIORITY|Comparison of changes in score from baseline.||||||0.8251|||||||Mixed Models Analysis|||||||0.8251
71692281|NCT03990051|142899591|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0435|||||||Mixed Models Analysis|||||||0.0435
71692282|NCT03990051|142899592|SUPERIORITY|Comparison of changes in score from baseline.||||||0.013|||||||Mixed Models Analysis|||||||0.0130
71692283|NCT03990051|142899593|SUPERIORITY|Comparison of changes in score from baseline.||||||0.3205|||||||Mixed Models Analysis|||||||0.3205
71692284|NCT03990051|142899594|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1401|||||||Mixed Models Analysis|||||||0.1401
71692285|NCT03990051|142899595|SUPERIORITY|Comparison in changes in score from baseline.||||||0.0098|||||||ANCOVA|||||||0.0098
71692286|NCT03990051|142899596|SUPERIORITY|Comparison of changes in score from baseline.||||||0.1032|||||||Mixed Models Analysis|||||||0.1032
71692287|NCT03990051|142899597|SUPERIORITY|Comparison of changes in score from baseline.||||||0.0389|||||||Mixed Models Analysis|||||||0.0389
71936748|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.46|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936749|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.61|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936750|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.39|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71692288|NCT03990051|142899598|OTHER||||||<|1e-05|||||||t-test, 2 sided|||Score in 1 year compared to baseline||||<0.00001
71692289|NCT03990051|142899599|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692290|NCT03990051|142899600|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71936751|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.1|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936752|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|1.65|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71936753|NCT01492582|143393955|NON_INFERIORITY|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was \>0.5.|lower bound one-sided CI of GMT ratio|-0.44|||||TWO_SIDED|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|||
71692291|NCT03990051|142899601|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692292|NCT03990051|142899602|OTHER|||||||0.0002|||||||t-test, 2 sided|||||||0.0002
71692293|NCT03990051|142899603|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71692294|NCT03990051|142899604|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692295|NCT03990051|142899605|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692296|NCT03990051|142899606|SUPERIORITY||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692297|NCT03990051|142899607|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692298|NCT03990051|142899608|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692299|NCT03990051|142899609|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692300|NCT03990051|142899610|OTHER|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71692301|NCT03990051|142899611|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692302|NCT03990051|142899612|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692303|NCT03990051|142899613|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692304|NCT03990051|142899614|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692305|NCT03990051|142899615|OTHER||||||<|1e-05|||||||t-test, 2 sided|||||||<0.00001
71692306|NCT01411852|142899617|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.39|||||TWO_SIDED|95.0|0.12|1.25|||||Adjusted for age (linear spline with knot at 45 years), penetrating vs. blunt or no trauma (1 patient had neither blunt nor penetrating trauma), and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||1.25|0.12|
71692307|NCT01411852|142899618|SUPERIORITY_OR_OTHER||percent difference|-16.0|||||TWO_SIDED|95.0|-26.5|-5.5||||||||-5.5|-26.5|
71692308|NCT01411852|142899619|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.18|||||TWO_SIDED|95.0|-2.76|0.4||||||||0.40|-2.76|
71692309|NCT01411852|142899620|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.77|||||TWO_SIDED|95.0|-1.61|0.08||||||||0.08|-1.61|
71692310|NCT01411852|142899621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|||||TWO_SIDED|95.0|-1.8|2.2||||||||2.2|-1.8|
71692311|NCT01411852|142899622|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|||||TWO_SIDED|95.0|-0.3|1.0||||||||1.0|-0.3|
71692312|NCT01411852|142899623|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-20.4|||||TWO_SIDED|95.0|-42.5|1.6||||||||1.6|-42.5|
71692313|NCT01411852|142899624|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|||||TWO_SIDED|95.0|-0.06|0.1||||||||0.10|-0.06|
71936754|NCT01492582|143393956|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||<0.001
71936755|NCT01492582|143393956|SUPERIORITY|||||||0.03|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.03
71936756|NCT01492582|143393956|SUPERIORITY|||||||0.48|||||||Chi-squared, Corrected|||Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6||||0.48
71936757|NCT01492582|143393956|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||<0.001
71936758|NCT01492582|143393956|SUPERIORITY|||||||0.07|||||||Chi-squared, Corrected|||Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.07
71936759|NCT01492582|143393956|SUPERIORITY|||||||0.28|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.28
71936760|NCT01492582|143393956|SUPERIORITY|||||||0.45|||||||Fisher Exact|||Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5||||0.45
71936761|NCT03907280|143393984|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T1/R) [%]|0.5|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|0.39|0.63|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||0.63|0.39|
71936762|NCT03907280|143393984|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T2/R) [%]|40.26|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.68|51.15|||Mixed Models Analysis||The standard error of the mean is actually the geometric standard error.|Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||51.15|31.68|
71692314|NCT01411852|142899625|SUPERIORITY_OR_OTHER||percent difference|-10.2|||||TWO_SIDED|95.0|-22.4|2.0||||||||2.0|-22.4|
71692315|NCT01411852|142899626|SUPERIORITY_OR_OTHER||percent difference|-18.9|||||TWO_SIDED|95.0|-39.2|1.4||||||||1.4|-39.2|
71692316|NCT01411852|142899627|SUPERIORITY_OR_OTHER||percent difference|-10.4|||||TWO_SIDED|95.0|-29.6|8.8||||||||8.8|-29.6|
71692317|NCT01411852|142899628|SUPERIORITY_OR_OTHER||percent difference|-4.4|||||TWO_SIDED|95.0|-16.6|7.8||||||||7.8|-16.6|
71692318|NCT01411852|142899629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||||TWO_SIDED|95.0|-3.8|2.1||||||||2.1|-3.8|
71692319|NCT01411852|142899630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|||||TWO_SIDED|95.0|-3.6|2.4||||||||2.4|-3.6|
71692320|NCT01411852|142899631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-2.9|3.1||||||||3.1|-2.9|
71692321|NCT01411852|142899632|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.17|||||TWO_SIDED|95.0|0.03|0.92|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS). ISS multiply imputed for one patient.|||0.92|0.03|
71692322|NCT01411852|142899633|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.92|||||TWO_SIDED|95.0|0.19|19.11|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS).|||19.11|0.19|
71692323|NCT01411852|142899634|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62|||||TWO_SIDED|95.0|0.22|1.77|||||Adjusted for age (linear spline with knot at 45 years), penetrating mechanism (yes/no), and ISS (linear).|||1.77|0.22|
71692324|NCT03126786|142899643|SUPERIORITY|The sample size was determined such that the difference in visual acuity between the ACTIVE treatment group and CONTROL treatment group could be estimated within +/- five ETDRS letters. Week 24 data from the Eylea prescribing information was used to estimate a pooled standard deviation of 9.17 letters. With 28 subjects per arm, a two-sided 90% confidence interval with a distance from the mean difference to the limits (half of interval width) will be less than 5 letters.|Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|2.28||0.288|TWO_SIDED|90.0|-6.2|1.4||There was a single primary outcome tested at a single primary endpoint, therefore no adjustments for multiple comparisons were performed. The primary endpoint was assess with a 2-sided alpha level of 0.100.|Mixed model for repeat measures|The covariance structure was assumed to be unstructured.|Estimated Value calculated as Active minus Control.|The primary efficacy analysis comparing ACTIVE with CONTROL on the mean change from baseline (Visit 2, Day 0) BCVA at Week 12 was be performed using a Mixed Model for Repeated Measurements (MMRM). This model included treatment (ACTIVE or CONTROL), visit (Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20) and Visit 8 (Week 24), and the 2-way interactions of treatment and visit, and the BCVA baseline included as the covariate.||1.4|-6.2|0.288
71692325|NCT00379899|142899656|SUPERIORITY_OR_OTHER|||||||0.073|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)||||||0.073
71692326|NCT00379899|142899657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.62||||0.094||95.0|0.36|1.08|||Cochran-Mantel-Haenszel||Logit estimates (Cinacalcet:Control)|||1.08|0.36|0.094
71692327|NCT00379899|142899658|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.018
71692328|NCT00379899|142899660|SUPERIORITY_OR_OTHER|||||||0.258|||||||Cochran-Mantel-Haenszel|||||||0.258
71692329|NCT00379899|142899661|SUPERIORITY_OR_OTHER|||||||0.011|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.011
71692330|NCT00379899|142899662|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71692331|NCT00379899|142899663|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71692332|NCT00379899|142899664|SUPERIORITY_OR_OTHER|||||||0.025|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.025
71692333|NCT00379899|142899665|SUPERIORITY_OR_OTHER|||||||0.021|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||0.021
71692334|NCT00379899|142899666|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71692335|NCT00379899|142899667|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor||||||<0.001
71692336|NCT03804268|142899681|SUPERIORITY||Percentage Difference|22.5|||<|0.0001|TWO_SIDED|95.0|14.3|30.8||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||30.8|14.3|<0.0001
71692337|NCT03804268|142899682|SUPERIORITY||Percentage Difference|9.7||||0.0114|TWO_SIDED|95.0|2.3|17.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||17.0|2.3|0.0114
71692338|NCT03804268|142899683|SUPERIORITY||Percentage Difference|2.1||||1|TWO_SIDED|95.0|-4.4|8.5||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||8.5|-4.4|1.0000
71692339|NCT03804268|142899684|SUPERIORITY||Least Square (LS) Mean Difference|5.1|STANDARD_ERROR_OF_MEAN|0.72||0.0114|TWO_SIDED|95.0|3.7|6.5||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||6.5|3.7|0.0114
71692340|NCT03804268|142899685|SUPERIORITY||Percentage Difference|18.7||||0.0114|TWO_SIDED|95.0|10.6|26.7||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval was calculated based on normal approximation based on pooled variance without continuity correction.|||26.7|10.6|0.0114
71692341|NCT03804268|142899686|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.14||0.0114|TWO_SIDED|95.0|0.6|1.1||Analysis of covariance (ANCOVA) was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.6|0.0114
71692342|NCT03804268|142899687|SUPERIORITY||LS Mean Difference|3.5|STANDARD_ERROR_OF_MEAN|0.55||0.0114|TWO_SIDED|95.0|2.4|4.6||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||4.6|2.4|0.0114
71692343|NCT03804268|142899688|SUPERIORITY||Percentage Difference|-1.1||||1|TWO_SIDED|95.0|-7.1|5.0||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||5.0|-7.1|1.0000
71692344|NCT03804268|142899689|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|0.66||0.0114|TWO_SIDED|95.0|1.3|3.9||MMRM with fixed effects: study intervention group,visit,visit by study intervention group interaction,age group,Baseline binocular DCNVA severity,iris color,emmetrope/non-emmetrope, Baseline value, and Baseline value by visit interaction was used.|MMRM|P-value was adjusted for multiplicity control.||||3.9|1.3|0.0114
71692345|NCT03804268|142899690|SUPERIORITY||Percentage Difference|12.6||||0.0171|TWO_SIDED|95.0|3.5|21.6||P-value was adjusted for multiplicity control.|Chi-squared||Analysis was done using Chi-square test. 95% confidence interval for the percentage differences was calculated based on the normal approximation based on pooled variance without continuity correction.|||21.6|3.5|0.0171
71692346|NCT03804268|142899691|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|0.13||0.0114|TWO_SIDED|95.0|0.5|1.1||ANCOVA was used with study intervention group, age group, baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||1.1|0.5|0.0114
71692347|NCT03804268|142899692|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.09||0.0114|TWO_SIDED|95.0|-0.6|-0.3||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.3|-0.6|0.0114
71936763|NCT03907280|143393984|OTHER|Absolute bioavailability comparison|Ratio of the geometric means (T3/R) [%]|40.24|STANDARD_ERROR_OF_MEAN|1.15|||TWO_SIDED|90.0|31.86|50.83|||Mixed Models Analysis|The standard error of the mean is actually the geometric standard error.||Exploratory trial, no formal hypotheses were tested. Analysis of variance (ANOVA) on the logarithmic scale including effects for treatment sequence ('fixed effect'), subjects nested within treatment sequences ('random effect'), and treatment ('fixed effect').||50.83|31.86|
71692348|NCT03804268|142899693|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.08||0.0114|TWO_SIDED|95.0|-0.4|-0.1||ANCOVA was used with study intervention group, age group, Baseline binocular DCNVA severity, iris color (brown/non-brown), emmetrope/non-emmetrope, and Baseline domain score as fixed effects.|ANCOVA|P-value was adjusted for multiplicity control.||||-0.1|-0.4|0.0114
71692349|NCT01156805|142899706|SUPERIORITY|||||||0.05|||||||Mixed Models Analysis|Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time||||||0.05
71692350|NCT01843803|142899710|SUPERIORITY||Mean Difference (Final Values)|2.7|STANDARD_ERROR_OF_MEAN|1.5||0.029|TWO_SIDED|||||"P-Value = 0.029 after adjusting for clinical and demographic, and accounting for clustering of patients within providers.~Comparison of adjusted CARES score yielded a significant difference."|Mixed Models Analysis|A mixed model was ran with CARES as the dependent variable, adjusted for demographic and clinical measures , and provider as a random effect.||Mixed model adjusted for gender, race, education, marital status, mental health condition, substance disorder, COPD, heart failure, diabetes, coronary artery disease, study site and accounting for clustering of patients within providers.||||0.029
71692351|NCT01843803|142899712|SUPERIORITY||Odds Ratio (OR)|1.69||||0.065|TWO_SIDED|95.0|0.99|2.86||P-Value derived after adjusting model provider clustering and treating it as a random effect.|Mixed Models Analysis|||Assessed whether a person in the intervention group vs the attention control group was more likely to be probed at least once by their provider after adjusting for other measures and accounting for the provider clustering.||2.86|0.99|.065
71692352|NCT01843803|142899713|SUPERIORITY||||||<|0.05|||||||Chi-squared|||chi-square||||<0.05
71692353|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|0.64|||||TWO_SIDED|95.0|0.37|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.37|
71692354|NCT03311841|142899714|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.77|2.31||||||Comparison of midazolam||2.31|0.77|
71692355|NCT03311841|142899714|OTHER|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.56|1.62||||||Comparison of midazolam||1.62|0.56|
71692356|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.23|
71936764|NCT01172600|143393985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.84|TWO_SIDED|95.0|-1.43|1.17|||Regression, Linear|The analysis adjusted for VAS at baseline (before 1st block), number of epidural blocks received, and imbalanced baseline variables.|This is an intention- to-treat analysis. We assigned missing outcomes to 10 patients.|||1.17|-1.43|0.84
71936765|NCT01172600|143393985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.12|TWO_SIDED|95.0|-2.34|0.28|||Regression, Linear||This is a per-protocol analysis, using 68 patients with completed data.|||0.28|-2.34|0.12
71692357|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.01|||||TWO_SIDED|95.0|0.53|1.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.93|0.53|
71692358|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|2.87|||||TWO_SIDED|95.0|1.51|5.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.47|1.51|
71692359|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|4.98|||||TWO_SIDED|95.0|2.62|9.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.48|2.62|
71692360|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|3.39|||||TWO_SIDED|95.0|1.78|6.44|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||6.44|1.78|
71692361|NCT03311841|142899714|OTHER|Comparison of pitavastatin|Geometric least squares mean ratio|1.32|||||TWO_SIDED|95.0|0.76|2.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.31|0.76|
71936766|NCT01172600|143393986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.63|TWO_SIDED|98.3|-1.8|1.21|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||1.21|-1.80|0.63
71692362|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.96|||||TWO_SIDED|95.0|1.12|3.42|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.42|1.12|
71692363|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.73|2.13|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.13|0.73|
71692364|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.74|2.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.27|0.74|
71692365|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.05|||||TWO_SIDED|95.0|0.64|1.72|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.72|0.64|
71692366|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.88|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.38|0.88|
71692367|NCT03311841|142899714|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.68|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.76|0.68|
71692368|NCT03311841|142899714|OTHER|Comparison of pitavastatin lactone|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.43|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.17|0.43|
71936767|NCT01172600|143393987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.16|TWO_SIDED|98.3|-3.05|0.82|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.|||0.82|-3.05|0.16
71936768|NCT00909727|143393998|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|6.6|18.3||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline value of percent predicted FEV1.||18.3|6.6|<0.0001
71936769|NCT00909727|143393999|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|2.7||0.0006|TWO_SIDED|95.0|4.5|15.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. no imputation of missing data was done.||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM). Estimates were obtained from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit \& treatment group, \& adjustment for the continuous baseline value of percent predicted FEV1, using unstructured covariance matrix.||15.5|4.5|0.0006
71936770|NCT00909727|143394000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.1|STANDARD_ERROR_OF_MEAN|3.7||0.1092|TWO_SIDED|95.0|-1.4|13.5||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||13.5|-1.4|0.1092
71936771|NCT00909727|143394000|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.1|STANDARD_ERROR_OF_MEAN|3.3||0.1354|TWO_SIDED|95.0|-1.6|11.8||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.||11.8|-1.6|0.1354
71936772|NCT00909727|143394001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-54.3|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-61.8|-46.8||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.8|-61.8|<0.0001
71936773|NCT00909727|143394001|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-53.5|STANDARD_ERROR_OF_MEAN|3.7|<|0.0001|TWO_SIDED|95.0|-60.9|-46.0||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.||-46.0|-60.9|<0.0001
71936774|NCT00909727|143394002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9|STANDARD_ERROR_OF_MEAN|0.5||0.0004|TWO_SIDED|95.0|0.9|2.9||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||At Week 24: Analysis for this variable was based on a Linear Mixed Effect (LME) model with dependent variable weight; treatment as a fixed effect; and intercept, visit, and treatment by visit interaction as random effects, with adjustment for baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||2.9|0.9|0.0004
71936775|NCT00909727|143394002|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|0.7||0.0002|TWO_SIDED|95.0|1.3|4.2||P-value is for the treatment effect at Week 48 (obtained as a linear contrast of treatment at Day 336). There was no adjustment for multiple comparisons.|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a Linear Mixed Effect (LME) model with random intercept and random slope, treatment as a fixed effect, and visit (days on study) and treatment by visit interaction as random effects, with adjustment for categorical baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.||4.2|1.3|0.0002
71936776|NCT04081337|143394011|SUPERIORITY||LS Mean Difference|19.68||||0.5733|TWO_SIDED|95.0|-50.36|89.72|||ANCOVA|||||89.72|-50.36|0.5733
71936777|NCT04081337|143394012|SUPERIORITY||LS Mean Difference|-855.94|||<|0.0001|TWO_SIDED|95.0|-1090.87|-621.02|||ANCOVA|||||-621.02|-1090.87|<0.0001
71936778|NCT04081337|143394013|SUPERIORITY||LS Mean Difference|-3.22||||0.9481|TWO_SIDED|95.0|-102.65|96.2|||ANCOVA|||||96.20|-102.65|0.9481
71936779|NCT04081337|143394014|SUPERIORITY||LS Mean Difference|-0.034|||<|0.0001|TWO_SIDED|95.0|-0.051|-0.018|||ANCOVA|||||-0.018|-0.051|<0.0001
71936780|NCT04081337|143394015|SUPERIORITY||LS Mean difference|-0.028||||0.0031|TWO_SIDED|95.0|-0.045|-0.01|||ANCOVA|||||-0.010|-0.045|0.0031
71936781|NCT04081337|143394016|SUPERIORITY||LS Mean difference|251.89||||0.0004|TWO_SIDED|95.0|119.09|384.69|||ANCOVA|||||384.69|119.09|0.0004
71936782|NCT04081337|143394017|SUPERIORITY||LS Mean difference|-6.87||||0.0005|TWO_SIDED|95.0|-10.51|-3.22|||ANCOVA|||For Adjusted protein oxidation||-3.22|-10.51|0.0005
71936783|NCT04081337|143394017|SUPERIORITY||LS Mean difference|14.48|||<|0.0001|TWO_SIDED|95.0|8.02|20.93|||ANCOVA|||For Adjusted fat oxidation||20.93|8.02|<0.0001
71936784|NCT04081337|143394017|SUPERIORITY||LS Mean difference|-26.64||||0.0001|TWO_SIDED|95.0|-39.46|-13.83|||ANCOVA|||Adjusted carbohydrate oxidation||-13.83|-39.46|0.0001
71936785|NCT04081337|143394018|SUPERIORITY||LS Mean difference|-8.47|||<|0.0001|TWO_SIDED|95.0|-11.04|-5.9|||Mixed Models Analysis|||||-5.90|-11.04|<0.0001
71692369|NCT03311841|142899714|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.53|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.41|0.53|
71692370|NCT03311841|142899714|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.89|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.46|0.89|
71692371|NCT03311841|142899714|OTHER||Geometric least squares mean ratio|1.63|||||TWO_SIDED|95.0|0.85|3.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.14|0.85|
71692372|NCT03311841|142899714|OTHER|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.57|2.22|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.22|0.57|
71692373|NCT03311841|142899714|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.38|||||TWO_SIDED|95.0|0.76|2.49|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.49|0.76|
71692374|NCT03311841|142899714|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.75|2.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.29|0.75|
71692375|NCT03311841|142899714|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.65|1.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.81|0.65|
71692376|NCT03311841|142899714|OTHER|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|0.79|||||TWO_SIDED|95.0|0.46|1.33|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.33|0.46|
71692377|NCT03311841|142899714|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.9|||||TWO_SIDED|95.0|0.33|2.45|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||2.45|0.33|
71692378|NCT03311841|142899714|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|0.75|5.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||5.14|0.75|
71692379|NCT03311841|142899714|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.49|3.16|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||3.16|0.49|
71692380|NCT03311841|142899714|OTHER|Comparison of rosuvastatin|Geometric least squares mean ratio|0.71|||||TWO_SIDED|95.0|0.27|1.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|||1.86|0.27|
71692381|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|0.67|||||TWO_SIDED|95.0|0.4|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.40|
71692382|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.76|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.09|0.76|
71692383|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|0.93|||||TWO_SIDED|95.0|0.57|1.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.52|0.57|
71692384|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|0.42|||||TWO_SIDED|95.0|0.25|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.70|0.25|
71692385|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|0.96|||||TWO_SIDED|95.0|0.53|1.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.73|0.53|
71692386|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|2.38|||||TWO_SIDED|95.0|1.32|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||4.32|1.32|
71936786|NCT04081337|143394019|SUPERIORITY||LS Mean difference|-4.08|||<|0.0001|TWO_SIDED|95.0|-5.12|-3.05|||Mixed Models Analysis|||||-3.05|-5.12|<0.0001
71936787|NCT04081337|143394020|SUPERIORITY||LS Mean difference|-5.08|||<|0.0001|TWO_SIDED|95.0|-6.93|-3.22|||ANCOVA|||||-3.22|-6.93|<0.0001
71936788|NCT04081337|143394021|SUPERIORITY||LS Mean Difference|-1.14||||0.0304|TWO_SIDED|95.0|-2.16|-0.11|||ANCOVA|||||-0.11|-2.16|0.0304
71936789|NCT04081337|143394022|SUPERIORITY||LS Mean difference|-1.83|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.06|||ANCOVA|||For Triglyceride||-1.06|-2.60|<0.0001
71936790|NCT04081337|143394022|SUPERIORITY||LS Mean difference|-0.84|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.48|||ANCOVA|||For VLDL||-0.48|-1.19|<0.0001
71936791|NCT04081337|143394022|SUPERIORITY||LS Mean difference|-0.53||||0.0436|TWO_SIDED|95.0|-1.05|-0.02|||ANCOVA|||For HDL||-0.02|-1.05|0.0436
71936792|NCT04081337|143394022|SUPERIORITY||LS Mean Difference|0.45||||0.0002|TWO_SIDED|95.0|0.23|0.66|||ANCOVA|||For Free fatty acid||0.66|0.23|0.0002
71936793|NCT04081337|143394023|SUPERIORITY||LS Mean Difference|0.03||||0.8762|TWO_SIDED|95.0|-0.34|0.4|||ANCOVA|||||0.40|-0.34|0.8762
71936794|NCT04081337|143394024|SUPERIORITY||LS Mean difference|3.49||||0.0126|TWO_SIDED|95.0|0.79|6.19|||ANCOVA|||||6.19|0.79|0.0126
71936795|NCT04081337|143394025|SUPERIORITY||LS Mean Difference|-1.26||||0.0222|TWO_SIDED|95.0|-2.34|-0.19|||ANCOVA|||||-0.19|-2.34|0.0222
71936796|NCT04081337|143394026|SUPERIORITY||LS Mean difference|-0.36|||<|0.0001|TWO_SIDED|95.0|-0.48|-0.23|||ANCOVA|||||-0.23|-0.48|<0.0001
71936797|NCT01578707|143394043|SUPERIORITY||||||<|0.0001|||||||Log Rank|||||||<0.0001
71936798|NCT01578707|143394044|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
71936799|NCT01578707|143394045|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1653|||||||Log Rank|||||||0.1653
71936800|NCT03175120|143394061|SUPERIORITY||Treatment contrast|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.09|-0.75|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.||-0.75|-1.09|<.0001
71936801|NCT00678392|143394122|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.665|||<|0.0001|TWO_SIDED|95.0|0.544|0.812||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.|Log Rank|||||0.812|0.544|<0.0001
71936802|NCT00678392|143394123|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.969||||0.3744|TWO_SIDED|95.0|0.8|1.174|||Log Rank|P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.||||1.174|0.800|0.3744
71936803|NCT00678392|143394124|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.056||||0.0001|TWO_SIDED|95.0|1.408|3.003|||Cochran-Mantel-Haenszel|P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.||||3.003|1.408|0.0001
71936804|NCT00770991|143394146|SUPERIORITY_OR_OTHER|||||||0.065|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.||||0.065
71936805|NCT00770991|143394147|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED|95.0|||||Chi-squared|||||||0.016
71936806|NCT00770991|143394148|SUPERIORITY_OR_OTHER|||||||0.043|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.043
71936807|NCT01945138|143394188|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED||||||t-test, 2 sided|||||||0.003
71936808|NCT01945138|143394189|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||t-test, 2 sided|||||||0.115
71936809|NCT01945138|143394190|SUPERIORITY_OR_OTHER|||||||0.193|TWO_SIDED||||||t-test, 2 sided|||||||0.193
71936810|NCT01945138|143394191|SUPERIORITY_OR_OTHER|||||||0.848|TWO_SIDED||||||t-test, 2 sided|||||||0.848
71936811|NCT01945138|143394192|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
71936812|NCT01945138|143394193|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||t-test, 2 sided|||||||0.38
71936813|NCT01945138|143394194|SUPERIORITY_OR_OTHER|||||||0.461|TWO_SIDED||||||t-test, 2 sided|||||||0.461
71936814|NCT01945138|143394195|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||t-test, 2 sided|||||||0.205
71936815|NCT01945138|143394196|SUPERIORITY_OR_OTHER|||||||0.157|TWO_SIDED||||||t-test, 2 sided|||||||0.157
71936816|NCT01945138|143394197|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||t-test, 2 sided|||||||0.443
71936817|NCT01945138|143394198|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||t-test, 2 sided|||||||0.04
71936818|NCT01945138|143394199|SUPERIORITY_OR_OTHER|||||||0.401|TWO_SIDED||||||t-test, 2 sided|||||||0.401
71936819|NCT01945138|143394200|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71936820|NCT01945138|143394201|SUPERIORITY_OR_OTHER|||||||0.325|TWO_SIDED||||||t-test, 2 sided|||||||0.325
71936821|NCT01945138|143394202|SUPERIORITY_OR_OTHER|||||||0.311|TWO_SIDED||||||t-test, 2 sided|||||||0.311
71936822|NCT02040766|143394203|SUPERIORITY||Mean Difference (Final Values)|2.81||||0.0063|TWO_SIDED|95.0|0.796|4.821||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (inhaled corticosteroid (ICS) or non-corticosteroid (NCS) therapy) at the time of screening visit, during the run-in period, and during treatment.||4.821|0.796|0.0063
71936823|NCT02040766|143394203|SUPERIORITY||Mean Difference (Final Values)|0.63||||0.5332|TWO_SIDED|95.0|-1.354|2.614||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.614|-1.354|0.5332
71936824|NCT02040766|143394203|SUPERIORITY||Mean Difference (Final Values)|0.92||||0.3649|TWO_SIDED|95.0|-1.077|2.924||significance at 0.05|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.||2.924|-1.077|0.3649
71936825|NCT02040766|143394203|SUPERIORITY||Mean Difference (Final Values)|1.09||||0.2823|TWO_SIDED|95.0|-0.902|3.088|||ANCOVA|||||3.088|-0.902|0.2823
71936826|NCT02040766|143394204|SUPERIORITY||Mean Difference (Final Values)|11.3||||0.0001|TWO_SIDED|95.0|5.58|17.06|||Mixed Models Analysis|||||17.06|5.58|0.0001
71936827|NCT02040766|143394204|SUPERIORITY||Mean Difference (Final Values)|8.5||||0.0041|TWO_SIDED|95.0|2.71|14.24|||Mixed Models Analysis|||||14.24|2.71|0.0041
71936828|NCT02040766|143394204|SUPERIORITY||Mean Difference (Final Values)|7.6||||0.0103|TWO_SIDED|95.0|1.79|13.35|||Mixed Models Analysis|||||13.35|1.79|0.0103
71936829|NCT02040766|143394204|SUPERIORITY||Mean Difference (Final Values)|6.5||||0.0278|TWO_SIDED|95.0|0.71|12.23|||Mixed Models Analysis|||||12.23|0.71|0.0278
71936830|NCT02040766|143394205|SUPERIORITY||Mean Difference (Final Values)|11.7|||<|0.0001|TWO_SIDED|95.0|5.96|17.45|||Mixed Models Analysis|||||17.45|5.96|<0.0001
71936831|NCT02040766|143394205|SUPERIORITY||Mean Difference (Final Values)|10.0||||0.0007|TWO_SIDED|95.0|4.2|15.76|||Mixed Models Analysis|||||15.76|4.20|0.0007
71936832|NCT02040766|143394205|SUPERIORITY||Mean Difference (Final Values)|9.9||||0.0008|TWO_SIDED|95.0|4.11|15.68|||Mixed Models Analysis|||||15.68|4.11|0.0008
71936833|NCT02040766|143394205|SUPERIORITY||Mean Difference (Final Values)|8.7||||0.0031|TWO_SIDED|95.0|2.95|14.49|||Mixed Models Analysis|||||14.49|2.95|0.0031
71936834|NCT02040766|143394206|SUPERIORITY||Mean Difference (Final Values)|-0.36||||0.0002|TWO_SIDED|95.0|-0.548|-0.174|||Mixed Models Analysis|||||-0.174|-0.548|0.0002
71936835|NCT02040766|143394206|SUPERIORITY||Mean Difference (Final Values)|-0.14||||0.132|TWO_SIDED|95.0|-0.331|0.044|||Mixed Models Analysis|||||0.044|-0.331|0.1320
71936836|NCT02040766|143394206|SUPERIORITY||Mean Difference (Final Values)|-0.05||||0.5866|TWO_SIDED|95.0|-0.24|0.136|||Mixed Models Analysis|||||0.136|-0.240|0.5866
71936837|NCT02040766|143394206|SUPERIORITY||Mean Difference (Final Values)|-0.18||||0.0587|TWO_SIDED|95.0|-0.369|0.007|||Mixed Models Analysis|||||0.007|-0.369|0.0587
71936838|NCT02040766|143394207|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.0011|TWO_SIDED|95.0|-0.261|-0.065|||Mixed Models Analysis|||||-0.065|-0.261|0.0011
71936839|NCT02040766|143394207|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.0869|TWO_SIDED|95.0|-0.185|0.013|||Mixed Models Analysis|||||0.013|-0.185|0.0869
71936840|NCT02040766|143394207|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.4388|TWO_SIDED|95.0|-0.138|0.06|||Mixed Models Analysis|||||0.060|-0.138|0.4388
71936841|NCT02040766|143394207|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.1041|TWO_SIDED|95.0|-0.18|0.017|||Mixed Models Analysis|||||0.017|-0.180|0.1041
71936842|NCT02040766|143394208|SUPERIORITY|||||||0.287|||||||Log Rank|||||||0.2870
71936843|NCT02040766|143394208|SUPERIORITY|||||||0.5257|||||||Log Rank|||||||0.5257
71936844|NCT02040766|143394208|SUPERIORITY|||||||0.9982|||||||Log Rank|||||||0.9982
71936845|NCT02040766|143394208|SUPERIORITY|||||||0.7633|||||||Log Rank|||||||0.7633
71936846|NCT00696709|143394213|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
71936847|NCT00696709|143394214|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
71936848|NCT00696709|143394215|OTHER||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.||||||<0.0001
71936849|NCT00696709|143394216|OTHER|The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.|||||<|0.0001|||||||Longitudinal data analysis (LDA)|LDA with log-transformed VZV responses at each visit as response variables and visit as covariate.||||||<0.0001
71936850|NCT00696709|143394217|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
71936851|NCT00696709|143394217|OTHER||Difference in Percentage|1.6|||||TWO_SIDED|95.0|-9.2|8.8|||||Miettinen \& Nurminen|||8.8|-9.2|
71936852|NCT00696709|143394218|OTHER||Difference in Percentage|35.9|||<|0.001|TWO_SIDED|95.0|15.2|52.6|||Miettinen & Nurminen|||||52.6|15.2|<0.001
71936853|NCT00696709|143394218|OTHER||Difference in Percentage|40.4|||<|0.001|TWO_SIDED|95.0|19.6|57.0|||Miettinen & Nurminen|||||57.0|19.6|<0.001
71936854|NCT00696709|143394219|OTHER||Difference in Percentage|-4.7|||||TWO_SIDED|95.0|-25.3|16.1|||||Miettinen \& Nurminen|||16.1|-25.3|
71936855|NCT00696709|143394219|OTHER||Difference in Percentage|4.1|||||TWO_SIDED|95.0|-16.9|24.9|||||Miettinen \& Nurminen|||24.9|-16.9|
71936856|NCT00696709|143394220|OTHER||Difference in Percentage|1.6||||0.48|TWO_SIDED|95.0|-9.3|8.4|||Miettinen & Nurminen|||||8.4|-9.3|0.480
71936857|NCT00696709|143394220|OTHER||Difference in Percentage|1.6||||0.469|TWO_SIDED|95.0|-9.2|8.8|||Miettinen & Nurminen|||||8.8|-9.2|0.469
71936858|NCT00696709|143394221|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|5.7|||||Miettinen \& Nurminen|||5.7|-10.8|
71936859|NCT00696709|143394221|OTHER||Difference in Percentage|0.0|||||TWO_SIDED|95.0|-10.8|6.0|||||Miettinen \& Nurminen|||6.0|-10.8|
71936860|NCT01360450|143394224|OTHER||Mean Difference (Final Values)|0.05|||>|0.05|TWO_SIDED|||||yes the P value was adjusted for multiple comparisons.|ANOVA|2 sided ANOVA|Mean difference between the two treatment arms|||||>0.05
71936861|NCT00526890|143394233|OTHER|||||||0.3149|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.||||0.3149
71936862|NCT03529955|143394239|EQUIVALENCE|The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||||0.01||||||The investigators hypothesized that genes identified as significantly differentially expressed between the two groups will have ≥2-fold change at p\<0.01.|ANOVA|||The student t test (paired) and ANOVA analysis of variance were used to assess the mean change in CDASI, MMT-8, DLQI and to compare the positive cell detection on immunohistochemistry for CCL5, pSTAT1 and pSTAT3 at baseline and 3 months post apremilast. All p values were two-sided, and values \<0.05 were considered statistically significant. Analyses were performed using GraphPad Prism 8 (GraphPad Software Inc.). The last observation carried forward approach was used for missing values.||||0.01
71936863|NCT03740100|143394243|OTHER||Percent with objective response|17.0|||||TWO_SIDED|95.0|1.0|58.0||||||The primary endpoint was to determine the objective response rate of patients with R/M HNSCC harboring NOTCH1 LOF mutations to oral bimiralisib using RECIST v1.1. We used a Simon's optimal two-stage design. In order to have 80% power to detect a response rate of 30%, (one-sided α=0.05 and β=0.20), we planned to enroll up to 10 patients in the first stage. If ≥ 2 patients had an objective response, then the study would enroll an additional 19 patients in the second stage.||58|1|
71936864|NCT02004847|143394250|SUPERIORITY_OR_OTHER|||||||0.0005|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.||||0.0005
71936865|NCT02004847|143394251|SUPERIORITY_OR_OTHER|||||||0.0036|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.||||0.0036
71936866|NCT02004847|143394252|SUPERIORITY_OR_OTHER|||||||0.3075|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.||||0.3075
71936867|NCT02004847|143394253|SUPERIORITY_OR_OTHER|||||||0.014|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.||||0.0140
71936868|NCT02004847|143394253|SUPERIORITY_OR_OTHER|||||||0.0064|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.||||0.0064
71936869|NCT02004847|143394253|SUPERIORITY_OR_OTHER|||||||0.102|TWO_SIDED||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.||||0.1020
71936870|NCT05321810|143394271|OTHER|||||||0.016|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.016
71936871|NCT05321810|143394276|OTHER||Hazard Ratio (HR)|0.812||||0.013|TWO_SIDED|95.0|0.69|0.957|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.957|0.690|0.013
71936872|NCT05321810|143394282|OTHER|||||||0.002|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.002
71936873|NCT05321810|143394285|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
71936874|NCT05321810|143394286|OTHER||Hazard Ratio (HR)|0.57|||<|0.001|TWO_SIDED|95.0|0.42|0.773|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.773|0.420|<0.001
71936875|NCT05321810|143394288|OTHER|||||||0.35|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.350
71936876|NCT05321810|143394289|OTHER||Hazard Ratio (HR)|1.155||||0.324|TWO_SIDED|95.0|0.867|1.54|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.540|0.867|0.324
71936877|NCT05321810|143394291|OTHER|||||||0.111|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.111
71936878|NCT05321810|143394292|OTHER||Hazard Ratio (HR)|0.866||||0.1|TWO_SIDED|95.0|0.73|1.028|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.028|0.730|0.100
71936879|NCT05321810|143394294|OTHER|||||||0.979|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||0.979
71936880|NCT05321810|143394295|OTHER||Hazard Ratio (HR)|1.002||||0.978|TWO_SIDED|95.0|0.854|1.177|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|1.177|0.854|0.978
71936881|NCT05321810|143394297|OTHER||||||<|0.001|||||||Log Rank|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|||<0.001
71936882|NCT05321810|143394298|OTHER||Hazard Ratio (HR)|0.428|||<|0.001|TWO_SIDED|95.0|0.263|0.697|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.697|0.263|<0.001
71936883|NCT05321810|143394302|OTHER||Hazard Ratio (HR)|0.727||||0.001|TWO_SIDED|95.0|0.599|0.881|||t-test, 2 sided|||Statistical analysis has been presented for all time points from 0 to 24 months.|\[Not specified\]|0.881|0.599|0.001
71936884|NCT00803959|143394310|NON_INFERIORITY_OR_EQUIVALENCE|The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).|Difference in success % (UDS - no UDS)|-0.3|||||TWO_SIDED|95.0|-7.5|6.9|||Chi-squared|Noninferiority declared if the upper boundary of the two-sided 95% confidence interval for the difference in % success (UDS - no UDS) was \< 11%.|Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.|The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.||6.9|-7.5|
71936885|NCT00803959|143394311|SUPERIORITY_OR_OTHER|||||||0.63||95.0||||The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.|Chi-squared|No adjustments were made; test had 1 degree of freedom.||Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.||||0.63
71936886|NCT00803959|143394312|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|Chi-squared|No adjustments made; 1 degree of freedom test.||"Null hypothesis is that there is no difference in the proportion responding very much better or much better on the Patient Global Impression of Improvement at the 12 month visit."||||0.68
71936887|NCT00803959|143394313|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.|t-test, 2 sided|One df t test assumed equal variance; no evidence was found to the contrary.||Null hypothesis is that the two arms do not differ according to change in UDI score.||||0.68
71936888|NCT00803959|143394314|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.||Null hypothesis is that the 2 arms do not differ according to change in ISI score.||||0.40
71936889|NCT00803959|143394315|SUPERIORITY_OR_OTHER|||||||0.5||95.0||||P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.|t-test, 2 sided|The t test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ in change in MESA stress score.||||0.50
71936890|NCT00803959|143394316|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|The t test had 1 df and assumed equal variances; no evidence of different variances was found.||Null hypothesis is that the two arms do not differ according to change in MESA urgency score.||||0.19
71936891|NCT00803959|143394317|SUPERIORITY_OR_OTHER|||||||0.49||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05|t-test, 2 sided|T test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.||||0.49
71936892|NCT00803959|143394318|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|T test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.||||0.02
71936893|NCT00803959|143394319|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||t-test, 2 sided|The t test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.||||0.51
71936894|NCT00803959|143394320|SUPERIORITY_OR_OTHER|||||||0.51||95.0|||||Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months||||0.51
71936895|NCT00803959|143394321|SUPERIORITY_OR_OTHER|||||||0.28||95.0||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.|t-test, 2 sided|T test had 1 df and assumed equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.||||0.28
71936896|NCT00803959|143394322|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.|Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.||||0.19
71936897|NCT00434161|143394323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.679||||0.188|TWO_SIDED|97.5|0.351|1.313||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||1.313|0.351|0.188
71936898|NCT00434161|143394323|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.242||||0.468|TWO_SIDED|97.5|0.635|2.431||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.||2.431|0.635|0.468
71936899|NCT00434161|143394324|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.262||||0.245|TWO_SIDED|97.5|-4.303|30.828||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||30.828|-4.303|0.245
71936900|NCT00434161|143394324|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.014||||0.806|TWO_SIDED|97.5|-20.519|16.491||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel|||||16.491|-20.519|0.806
71936901|NCT00434161|143394325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.409|STANDARD_DEVIATION|6.82||0.095|TWO_SIDED|97.5|0.07|4.748||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||4.748|0.070|0.095
71936902|NCT00434161|143394325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.213|STANDARD_DEVIATION|6.13||0.806|TWO_SIDED|97.5|-2.575|2.15||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||2.150|-2.575|0.806
71936903|NCT00434161|143394326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.436||||0.142|TWO_SIDED|97.5|-1.542|32.415||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.||32.415|-1.542|0.142
71936904|NCT00434161|143394326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.331||||0.806|TWO_SIDED|97.5|-11.82|22.482||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||||22.482|-11.820|0.806
71936905|NCT00434161|143394327|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.88|||||TWO_SIDED|95.0|-21.669|33.43||According to statistical analysis plan it was not planned to calculate any P-Value.||||||33.43|-21.669|
71936906|NCT00434161|143394329|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.023|||||TWO_SIDED|95.0|-0.134|0.181||||||||0.181|-0.134|
71936907|NCT00434161|143394330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.061|||||TWO_SIDED|95.0|-0.138|0.26||||||||0.260|-0.138|
71936908|NCT00434161|143394331|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.689|||||TWO_SIDED|95.0|-21.641|14.264||||||||14.264|-21.641|
71936909|NCT00434161|143394332|SUPERIORITY_OR_OTHER||Risk Difference (RD)|5.951|||||TWO_SIDED|95.0|-0.679|12.58||||||||12.580|-0.679|
71936910|NCT00434161|143394334|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.64||||0.192|TWO_SIDED|95.0|0.33|1.26|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.26|0.33|0.192
71936911|NCT00434161|143394335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.417|||||TWO_SIDED|95.0|-11.086|45.919||||||||45.919|-11.086|
71936912|NCT00434161|143394336|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.236|TWO_SIDED|95.0|0.55|1.16|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.16|0.55|0.236
71936913|NCT00434161|143394337|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.84||||0.372|TWO_SIDED|95.0|0.58|1.23|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.||1.23|0.58|0.372
71936914|NCT03342898|143394339|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 120. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the seroprotection rate difference (Group 1 - Group 3) was less than 5%.|Seroprotection Rate Difference|0.4|||||TWO_SIDED|95.0|-1.85|2.69|||||The Newcombe score method was used to compute the 95% CI of the seroprotection rate difference.|||2.69|-1.85|
71936915|NCT03342898|143394340|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.6|||||TWO_SIDED|95.0|1.19|2.22|||||Analysis of variance (ANOVA) model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-1||2.22|1.19|
71936916|NCT03342898|143394340|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|1.03|1.75|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-2||1.75|1.03|
71936917|NCT03342898|143394340|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.3||||||95.0|0.99|1.61|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-3||1.61|0.99|
71936918|NCT03342898|143394340|NON_INFERIORITY|Non-inferiority of the immune response was performed only between TDV + YF (Group 3) and TDV + Placebo (Group 2) at Day 120. Non-inferiority between Group 3 and Group 2 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 2/Group 3) was less than 2.0.|Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.89|1.46|||||ANOVA model was used for analysis, including log-transformed value of titer as the dependent variable and trial group as a factor.|Day 120, DENV-4||1.46|0.89|
71936919|NCT03342898|143394344|NON_INFERIORITY|Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 30. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the GMT ratio (Group 1/Group 3) was less than 2.0.|Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.77|1.26|||||ANOVA model was used for analyses, including the log-transformed value of titer as the dependent variable and trial group as a factor.|||1.26|0.77|
71936920|NCT01387282|143394351|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
71936921|NCT01387282|143394352|SUPERIORITY_OR_OTHER|||||||0.648|||||||Wilcoxon rank sum test|||Superiority analysis||||0.6480
71936922|NCT01387282|143394353|SUPERIORITY_OR_OTHER|||||||0.0016|||||||Mixed Models Analysis|||Superiority analysis||||0.0016
71936923|NCT01387282|143394354|SUPERIORITY_OR_OTHER|||||||0.8637|||||||Mixed Models Analysis|||Superiority analysis||||0.8637
71936924|NCT01387282|143394355|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
71936925|NCT02661126|143394363|OTHER|Geometric least-squares mean ratio (GMR) of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.4|2.92||||||||2.92|1.40|
71936926|NCT02661126|143394364|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.0|||||TWO_SIDED|90.0|1.39|2.89||||||||2.89|1.39|
71936927|NCT02661126|143394365|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.39|2.92||||||||2.92|1.39|
71936928|NCT02661126|143394366|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.92|||||TWO_SIDED|90.0|1.35|2.74||||||||2.74|1.35|
71936929|NCT02661126|143394372|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.39|2.72||||||||2.72|1.39|
71936930|NCT02661126|143394373|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.02|||||TWO_SIDED|90.0|1.5|2.74||||||||2.74|1.50|
71936931|NCT02661126|143394374|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.72|||||TWO_SIDED|90.0|1.15|2.56||||||||2.56|1.15|
71936932|NCT02661126|143394375|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.85|||||TWO_SIDED|90.0|1.2|2.87||||||||2.87|1.20|
71692387|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|3.09|||||TWO_SIDED|95.0|1.75|5.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.48|1.75|
71692388|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.8|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||2.64|0.80|
71692389|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.31|||||TWO_SIDED|95.0|0.78|2.2|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.20|0.78|
71692390|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.09|3.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.09|1.09|
71692391|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.26|||||TWO_SIDED|95.0|0.77|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.09|0.77|
71692392|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.43|||||TWO_SIDED|95.0|0.85|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.85|
71936933|NCT02661126|143394376|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|2.03|||||TWO_SIDED|90.0|1.38|2.97||||||||2.97|1.38|
71936934|NCT02661126|143394380|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.91|||||TWO_SIDED|90.0|1.44|2.53||||||||2.53|1.44|
71936935|NCT02661126|143394381|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.97|||||TWO_SIDED|90.0|1.48|2.63||||||||2.63|1.48|
71692393|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.68|1.56|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.56|0.68|
71692394|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.83|1.92|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.92|0.83|
71692395|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.09|||||TWO_SIDED|95.0|0.73|1.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.63|0.73|
71692396|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|0.85|||||TWO_SIDED|95.0|0.56|1.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.29|0.56|
71692397|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.55|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.23|0.55|
71692398|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.66|||||TWO_SIDED|95.0|0.89|3.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.11|0.89|
71692399|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.52|||||TWO_SIDED|95.0|0.83|2.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.77|0.83|
71936936|NCT02661126|143394382|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.96|||||TWO_SIDED|90.0|1.54|2.48||||||||2.48|1.54|
71936937|NCT02661126|143394383|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.7|||||TWO_SIDED|90.0|1.29|2.24||||||||2.24|1.29|
71936938|NCT02661126|143394384|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.94|||||TWO_SIDED|90.0|1.47|2.57||||||||2.57|1.47|
71936939|NCT02661126|143394387|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.33|||||TWO_SIDED|90.0|0.65|2.75||||||||2.75|0.65|
71936940|NCT02661126|143394388|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.59|||||TWO_SIDED|90.0|0.79|3.19||||||||3.19|0.79|
71936941|NCT02661126|143394389|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.15|||||TWO_SIDED|90.0|0.51|2.57||||||||2.57|0.51|
71936942|NCT02661126|143394390|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.23|||||TWO_SIDED|90.0|0.5|3.05||||||||3.05|0.50|
71936943|NCT02661126|143394391|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.28|||||TWO_SIDED|90.0|0.56|2.91||||||||2.91|0.56|
71936944|NCT02661126|143394396|OTHER|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.56|||||TWO_SIDED|90.0|1.19|2.05||||||||2.05|1.19|
71936945|NCT02661126|143394397|OTHER|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.57|||||TWO_SIDED|90.0|1.2|2.05||||||||2.05|1.20|
71936946|NCT02661126|143394398|OTHER|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.49|||||TWO_SIDED|90.0|1.13|1.98||||||||1.98|1.13|
71936947|NCT02661126|143394399|OTHER|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.44|||||TWO_SIDED|90.0|1.05|1.98||||||||1.98|1.05|
71936948|NCT02661126|143394400|OTHER|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.54|||||TWO_SIDED|90.0|1.15|2.07||||||||2.07|1.15|
71936949|NCT01267266|143394405|SUPERIORITY_OR_OTHER|||||||0.2|TWO_SIDED||||||Log Rank|||||||0.20
71936950|NCT01828255|143394440|OTHER||||||<|0.005|||||||t-test, 2 sided|||||||<0.005
71936951|NCT02491788|143394447|SUPERIORITY||Mean Difference (Final Values)|2.16|STANDARD_ERROR_OF_MEAN|0.75|<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71692400|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.45|||||TWO_SIDED|95.0|0.78|2.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.71|0.78|
71936952|NCT01464827|143394449|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.406|TWO_SIDED|95.0|0.09|2.61||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Group G|"The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).~Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors."||2.61|0.09|0.406
71936953|NCT01464827|143394450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4||||0.266|TWO_SIDED|95.0|0.08|2.02||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.02|0.08|0.266
71936954|NCT01464827|143394450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.66||||0.525|TWO_SIDED|95.0|0.18|2.4||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||2.40|0.18|0.525
71936955|NCT01464827|143394450|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.64||||0.375|TWO_SIDED|95.0|0.55|4.92||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + K + L\] : Groups \[H + I + M + N\]|The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.||4.92|0.55|0.375
71936956|NCT01464827|143394451|SUPERIORITY_OR_OTHER||Difference|-12.16||||0.068|TWO_SIDED|95.0|-25.2|0.88||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group B - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.88|-25.20|0.068
71936957|NCT01464827|143394451|SUPERIORITY_OR_OTHER||Difference|-6.75||||0.065|TWO_SIDED|95.0|-13.93|0.43||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Groups \[C + D + J\] - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||0.43|-13.93|0.065
71936958|NCT01464827|143394452|SUPERIORITY_OR_OTHER||Difference|-7.13||||0.106|TWO_SIDED|95.0|-15.77|1.51||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group E - Groups \[F + G + K + L\]|The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).||1.51|-15.77|0.106
71936959|NCT01464827|143394453|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41||||0.616|TWO_SIDED|95.0|0.37|5.34||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups \[F + G + H + I\] : Groups \[K + L + M + N\]|The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.||5.34|0.37|0.616
71936960|NCT00268346|143394454|SUPERIORITY_OR_OTHER||percentage response|6.9|||<|0.05|TWO_SIDED|95.0|||||binomial test for a single proportion|||In patients with prior chemotherapy, \>25% response indicates efficacy and \<10% indicates lack of efficacy. In patients with no prior chemotherapy, \>45% response indicates efficacy and \<25% indicates lack of efficacy. Using a 5% significance level, the study was designed to have 80% power to test each hypothesis.||||<0.05
71936961|NCT00981253|143394459|SUPERIORITY||Mean Difference (Final Values)|-10.1|||||TWO_SIDED|95.0|-18.7|-1.5|||ANCOVA|||||-1.5|-18.7|
71936962|NCT00981253|143394460|SUPERIORITY||||||<|0.05|||||||ANCOVA|||||||<0.05
71936963|NCT00981253|143394461|SUPERIORITY||Cox Proportional Hazard|0.47|||||TWO_SIDED|95.0|0.24|0.91|||Log Rank|||||0.91|0.24|
71936964|NCT00981253|143394462|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.95|TWO_SIDED|95.0|-0.14|1.17|||ANCOVA|||||1.17|-0.14|.95
71936965|NCT00981253|143394463|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
71936966|NCT00981253|143394464|SUPERIORITY||Mean Difference (Final Values)|0.46||||0.99|TWO_SIDED|95.0|-0.78|1.74|||ANCOVA|||||1.74|-0.78|0.99
71936967|NCT00981253|143394465|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.99|TWO_SIDED|95.0|-0.22|0.46|||ANCOVA|||||0.46|-0.22|0.99
71936968|NCT00981253|143394465|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.99|TWO_SIDED|95.0|-0.14|0.39|||ANCOVA|||||0.39|-0.14|0.99
71936969|NCT03882047|143394466|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936970|NCT03882047|143394466|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936971|NCT03882047|143394466|OTHER|||||||0.03|||||||ANOVA|||||||0.03
71936972|NCT03882047|143394467|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936973|NCT03882047|143394467|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936974|NCT03882047|143394467|OTHER|||||||0.31|||||||ANOVA|||||||0.31
71936975|NCT03882047|143394468|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936976|NCT03882047|143394468|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936977|NCT03882047|143394468|OTHER|||||||0.01|||||||ANOVA|||||||0.01
71936978|NCT03882047|143394469|OTHER|||||||0.08|||||||ANOVA|||||||0.08
71936979|NCT03882047|143394469|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936980|NCT03882047|143394469|OTHER|||||||0.1|||||||ANOVA|||||||0.10
71936981|NCT03882047|143394470|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936982|NCT03882047|143394470|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936983|NCT03882047|143394470|OTHER|||||||0.01|||||||ANOVA|||||||0.01
71936984|NCT03882047|143394471|OTHER|||||||0.02|||||||ANOVA|||||||0.02
71936985|NCT03882047|143394471|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936986|NCT03882047|143394471|OTHER|||||||0.05|||||||ANOVA|||||||0.05
71936987|NCT03882047|143394472|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936988|NCT03882047|143394472|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936989|NCT03882047|143394472|OTHER|||||||0.06|||||||ANOVA|||||||0.06
71936990|NCT03882047|143394473|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936991|NCT03882047|143394473|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936992|NCT03882047|143394473|OTHER|||||||0.46|||||||ANOVA|||||||0.46
71936993|NCT03882047|143394474|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936994|NCT03882047|143394474|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936995|NCT03882047|143394474|OTHER|||||||0.07|||||||ANOVA|||||||0.07
71936996|NCT03882047|143394475|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936997|NCT03882047|143394475|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71936998|NCT03882047|143394475|OTHER|||||||0.53|||||||ANOVA|||||||0.53
71936999|NCT03882047|143394476|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71937000|NCT03882047|143394476|OTHER||||||<|0.01|||||||ANOVA|||||||<0.01
71937001|NCT03882047|143394476|OTHER|||||||0.12|||||||ANOVA|||||||0.12
71937002|NCT00358826|143394515|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71937003|NCT00358826|143394515|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71937004|NCT00358826|143394515|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71937005|NCT00358826|143394516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71937006|NCT00358826|143394516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71937007|NCT00358826|143394516|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.||||||<0.001
71937008|NCT00358826|143394517|SUPERIORITY_OR_OTHER|||||||0.656||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.656
71937009|NCT00358826|143394517|SUPERIORITY_OR_OTHER|||||||0.863||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.863
71937010|NCT00358826|143394517|SUPERIORITY_OR_OTHER|||||||0.996||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.996
71692401|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.28|||||TWO_SIDED|95.0|0.7|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.34|0.70|
71692402|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.78|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.28|0.78|
71692403|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.62|1.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.74|0.62|
71692404|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.62|1.82|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.82|0.62|
71692405|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.58|2.67|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.67|0.58|
71692406|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|2.25|||||TWO_SIDED|95.0|1.09|4.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.63|1.09|
71692407|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.72|2.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.93|0.72|
71937011|NCT00358826|143394518|SUPERIORITY_OR_OTHER|||||||0.331||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.331
71692408|NCT03311841|142899716|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.51|2.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.19|0.51|
71692409|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|0.63|||||TWO_SIDED|95.0|0.36|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.11|0.36|
71692410|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||2.28|0.75|
71692411|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.61|0.55|
71692412|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|0.4|||||TWO_SIDED|95.0|0.23|0.69|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.69|0.23|
71937012|NCT00358826|143394518|SUPERIORITY_OR_OTHER|||||||0.606||||||Adjusted using Dunnett's method.|ANCOVA|||||||0.606
71937013|NCT00358826|143394518|SUPERIORITY_OR_OTHER||||||<|0.001||||||Adjusted using Dunnett's method.|ANOVA|||||||<0.001
71937014|NCT00358826|143394519|SUPERIORITY_OR_OTHER|||||||0.22||||||Dunnett test compared with Placebo|ANCOVA|||||||0.22
71937015|NCT00358826|143394519|SUPERIORITY_OR_OTHER||||||<|0.005||||||Dunnett test compared with Placebo|ANCOVA|||||||<0.005
71937016|NCT00358826|143394519|SUPERIORITY_OR_OTHER|||||||0.6||||||Dunnett test compared with Placebo|ANCOVA|||||||0.60
71937017|NCT00358826|143394520|SUPERIORITY_OR_OTHER|||||||0.92||||||Dunnett test compared with Placebo|ANCOVA|||||||0.92
71692413|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.02|||||TWO_SIDED|95.0|0.53|1.95|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.95|0.53|
71692414|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|3.0|||||TWO_SIDED|95.0|1.57|5.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.74|1.57|
71692415|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|5.28|||||TWO_SIDED|95.0|2.83|9.87|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||9.87|2.83|
71692416|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.39|5.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||5.07|1.39|
71692417|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.76|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.34|0.76|
71937018|NCT00358826|143394520|SUPERIORITY_OR_OTHER|||||||0.96||||||Dunnett test compared with Placebo|ANCOVA|||||||0.96
71937019|NCT00358826|143394520|SUPERIORITY_OR_OTHER|||||||1||||||Dunnett test compared with Placebo|ANCOVA|||||||1.00
71937020|NCT00358826|143394521|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
71937021|NCT00358826|143394521|SUPERIORITY_OR_OTHER|||||||0.11||||||Dunnett test compared with Placebo|ANCOVA|||||||0.11
71937022|NCT00358826|143394521|SUPERIORITY_OR_OTHER|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA|||||||0.99
71937023|NCT00320593|143394545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.28|||||TWO_SIDED|95.0|0.01|0.55|||ANCOVA|||The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.||0.55|0.01|
71692418|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.97|||||TWO_SIDED|95.0|1.12|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.46|1.12|
71937024|NCT00320593|143394545|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.27|||||TWO_SIDED|95.0|0.02|0.53|||ANCOVA|||An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.||0.53|0.02|
71937025|NCT00320593|143394548|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.14|||||TWO_SIDED|95.0|-0.005|0.28|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.||0.28|-0.005|
71937026|NCT00320593|143394549|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.23|||||TWO_SIDED|95.0|0.02|0.45|||ANCOVA|||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.||0.45|0.02|
71937027|NCT00481247|143394555|SUPERIORITY_OR_OTHER|||||||0.0056||||||A priori threshold for statistical significance=0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Hasford Score.||||||0.0056
71692419|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.25|||||TWO_SIDED|95.0|0.72|2.15|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.15|0.72|
71692420|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.34|||||TWO_SIDED|95.0|0.76|2.36|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.36|0.76|
71937028|NCT00481247|143394556|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.55|1.13||||||||1.13|0.55|
71937029|NCT00481247|143394558|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.46|||||TWO_SIDED|95.0|1.2|1.77||||||Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects||1.77|1.20|
71937030|NCT00481247|143394559|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|1.25|1.89||||||Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects||1.89|1.25|
71937031|NCT01716754|143394564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.576|TWO_SIDED|95.0|0.35|1.78|||Regression, Logistic|||||1.78|0.35|0.576
71937032|NCT01716754|143394564|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.556|TWO_SIDED|95.0|0.46|1.52|||Regression, Logistic|||||1.52|0.46|0.556
71937033|NCT01716754|143394566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.32||||0.483|TWO_SIDED|95.0|0.61|2.86|||Regression, Logistic|||||2.86|0.61|0.483
71937034|NCT01716754|143394566|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.39||||0.261|TWO_SIDED|95.0|0.79|2.44|||Regression, Logistic|||||2.44|0.79|0.261
71937035|NCT01716754|143394568|SUPERIORITY_OR_OTHER|||||||0.604|||||||Repeated measures mixed model|||Morning||||0.604
71937036|NCT01716754|143394568|SUPERIORITY_OR_OTHER|||||||0.26|||||||Repeated measures mixed model|||Morning||||0.260
71937037|NCT01716754|143394568|SUPERIORITY_OR_OTHER|||||||0.937|||||||Repeated measures mixed model|||Evening||||0.937
71937038|NCT01716754|143394568|SUPERIORITY_OR_OTHER|||||||0.88|||||||Repeated measures mixed model|||Evening||||0.880
71937039|NCT01716754|143394568|SUPERIORITY_OR_OTHER|||||||0.762|||||||Repeated measures mixed model|||Overall daily||||0.762
71937040|NCT01716754|143394568|SUPERIORITY_OR_OTHER|||||||0.408|||||||Repeated measures mixed model|||Overall daily||||0.408
71937041|NCT01620489|143394579|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.66|||<|0.0001||95.0|-0.9|-0.43||Adjustment for multiple comparisons was not used since there was only one primary endpoint.|Mixed Models Analysis|||The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR\<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.||-0.43|-0.90|<0.0001
71937042|NCT01620489|143394580|SUPERIORITY_OR_OTHER||Estimated odds ratio|4.48|||<|0.0001||95.0|2.46|8.18||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c and body weight at baseline as covariates. No weight gain was defined as change from baseline to Week 26 in body weight ≤0 kg.||8.18|2.46|<0.0001
71937043|NCT01620489|143394581|SUPERIORITY_OR_OTHER||Estimated odds ratio|3.94|||<|0.0001||95.0|2.12|7.3||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.||7.30|2.12|<0.0001
71937044|NCT01620489|143394582|SUPERIORITY_OR_OTHER||Estimated treatment difference|-1.08|||<|0.0001||95.0|-1.58|-0.58||Not adjusted for multiple comparisons|Mixed Models Analysis|||Mean change from baseline in the 7-point profile (SMPG) after 26 weeks treatment was analysed using an MMRM model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.58|-1.58|<0.0001
71937045|NCT01620489|143394583|SUPERIORITY_OR_OTHER||Estimated treatment difference|-0.51|||=|0.0022||95.0|-0.83|-0.18|||Mixed Models Analysis|Not adjusted for multiple comparisons||Change from baseline in BMI (kg/m˄2) after 26 weeks treatment was analysed separately using an MMRM analysis model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.||-0.18|-0.83|= 0.0022
71937046|NCT01620489|143394584|SUPERIORITY_OR_OTHER||Estimated treatment ratio|0.98|||=|0.3575||95.0|0.94|1.02||Not adjusted for multiple comparisons|Mixed Models Analysis|||The ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 weeks treatment was estimated based on log-transformed data for changes from baseline. The responses were analysed using an MMRM model with treatment, country and stratification groups as fixed effects and log-transformed baseline as a covariate, all nested within visit. The resulting estimates were back-transformed to the original scale.||1.02|0.94|= 0.3575
71937047|NCT01714505|143394598|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 1 sided|Paired t-tests: compare LBGI, carbohydrates for hypoglycemia treatment, % of time in range and average BG on CLC vs OL.||||||0.003
71937048|NCT01714505|143394599|SUPERIORITY_OR_OTHER||||||>|0.1|||||||t-test, 1 sided|||||||>0.1
71937049|NCT01714505|143394600|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||||||0.02
71937050|NCT00321711|143394612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.032||||||95.0|0.153|6.95||||||||6.950|0.153|
71937051|NCT00321711|143394612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.333||||||95.0|0.028|3.926||||||||3.926|0.028|
71937052|NCT00321711|143394612|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.118||||||95.0|0.007|1.882|||||Adjusted by the stratification factor|||1.882|0.007|
71937053|NCT00321711|143394613|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||||95.0|0.063|15.988|||||Romiplostim/placebo|||15.988|0.063|
71937054|NCT00321711|143394614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.827||||||95.0|0.347|9.618|||||Romiplostim/placebo|||9.618|0.347|
71937055|NCT00321711|143394614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.445||||||95.0|0.037|5.325|||||Romiplostim/placebo|||5.325|0.037|
71937056|NCT00321711|143394614|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.444||||||95.0|0.032|6.08|||||Romiplostim/placebo|||6.080|0.032|
71937057|NCT00321711|143394615|SUPERIORITY_OR_OTHER||Difference in incidence rate|-33.5||||||95.0|-69.0|2.0|||||Romiplostim - placebo|||2.0|-69.0|
71937058|NCT00321711|143394615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.315||||||95.0|0.029|3.412||||||||3.412|0.029|
71937059|NCT00321711|143394615|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.211||||||95.0|0.021|2.082||||||||2.082|0.021|
71937060|NCT01832090|143394616|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71937061|NCT01832090|143394617|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71937062|NCT01832090|143394618|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Fisher Exact|||||||<0.0001
71937063|NCT01832090|143394619|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71937064|NCT01832090|143394620|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71937065|NCT01832090|143394621|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71937066|NCT01832090|143394624|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71937067|NCT01832090|143394625|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71937068|NCT01211769|143394636|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
71937069|NCT01211769|143394636|SUPERIORITY_OR_OTHER||Variance (F)|0.71||||0.69||95.0|||||ANOVA|||GROUP COMPARISON||||0.69
71937070|NCT01211769|143394637|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
71937071|NCT01211769|143394637|SUPERIORITY_OR_OTHER||Variance (F)|0.73||||0.53||95.0|||||ANOVA|||GROUP COMPARISON||||0.53
71937072|NCT01211769|143394638|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|||TIME COMPARISON||||<0.001
71937073|NCT01211769|143394638|SUPERIORITY_OR_OTHER||Variance (F)|1.08||||0.37||95.0|||||ANOVA|||GROUP COMPARISON||||0.37
71937074|NCT01484028|143394651|NON_INFERIORITY_OR_EQUIVALENCE|A non-inferiority margin of 0.05 LogMAR was used.|Least-square mean difference|0.011|STANDARD_ERROR_OF_MEAN|0.0034|||TWO_SIDED|95.0|0.004|0.017|||Mixed Models Analysis|||The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.||0.017|0.004|
71937075|NCT00926289|143394658|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.5|||<|0.0001||95.0|-10.6|-6.4|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-6.4|-10.6|<0.0001
71937076|NCT00926289|143394659|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.0001||95.0|-9.3|-5.2|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-5.2|-9.3|<0.0001
71937077|NCT00926289|143394660|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.8|||<|0.0001||95.0|-8.8|-4.7|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-4.7|-8.8|<0.0001
71937078|NCT00926289|143394661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001||95.0|-4.5|-1.9|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy||-1.9|-4.5|<0.0001
71937079|NCT00926289|143394662|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.36|||<|0.0001||95.0|1.74|3.21|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.21|1.74|<0.0001
71937080|NCT00926289|143394663|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3|||<|0.0001||95.0|1.7|3.12|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.12|1.70|<0.0001
71937081|NCT00926289|143394664|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19|||<|0.0001||95.0|1.6|3.01|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.01|1.60|<0.0001
71937082|NCT00926289|143394665|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.0|||<|0.0001||95.0|1.46|2.73|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.73|1.46|<0.0001
71937083|NCT00926289|143394666|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02|||<|0.0001||95.0|1.48|2.76|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||2.76|1.48|<0.0001
71937084|NCT00926289|143394667|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.74||||0.0005||95.0|1.28|2.37|||Regression, Logistic|Adjustment for continuous covariate of baseline and fixed effect country||T80+HCTZ25 versus T80 monotherapy||2.37|1.28|0.0005
71937085|NCT00926289|143394668|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39|||<|0.0001||95.0|1.76|3.26|||Regression, Logistic|Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.26|1.76|<0.0001
71937086|NCT00926289|143394669|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.0001||95.0|1.78|3.29|||Regression, Logistic|Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.29|1.78|<0.0001
71937087|NCT00926289|143394670|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62|||<|0.0001||95.0|1.7|4.04|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||4.04|1.70|<0.0001
71937088|NCT00926289|143394671|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.23|||<|0.0001||95.0|1.57|3.16|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy||3.16|1.57|<0.0001
71937089|NCT00926289|143394672|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Van Elteren test stratified for country|||T80+HCTZ25 versus T80 monotherapy||||<0.0001
71937090|NCT01149616|143394713|SUPERIORITY|||||||0.007|||||||ANOVA|||||||0.007
71937091|NCT01149616|143394714|SUPERIORITY|||||||0.006|||||||ANOVA|||||||0.006
71937092|NCT01149616|143394715|SUPERIORITY|||||||0.05||||||P value was calculated, and threshold for significance calculated at less than or equal to 0.05|ANOVA|||||||0.05
71937093|NCT01512979|143394718|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.17|<|0.0001||95.0|-1.13|-0.46||The model includes treatment and continuous baseline HbA1c.|ANCOVA|||||-0.46|-1.13|<0.0001
71937094|NCT01512979|143394719|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.0032||95.0|-28.0|-5.7||The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.|ANCOVA|||||-5.7|-28.0|0.0032
71937095|NCT01512979|143394721|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.83||||0.0031||95.0|1.573|9.328||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||9.328|1.573|0.0031
71937096|NCT01512979|143394722|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.0025||95.0|1.458|5.849||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||5.849|1.458|0.0025
71937097|NCT01512979|143394723|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.448||||0.0008||95.0|1.453|4.123||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic|||||4.123|1.453|0.0008
71937098|NCT04192799|143394736|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.74|||<|0.001|TWO_SIDED|95.0|0.65|0.85||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.85|0.65|<0.001
71937099|NCT04192799|143394737|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|1.12|||<|0.001|TWO_SIDED|95.0|1.06|1.19||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.19|1.06|<0.001
71937100|NCT04192799|143394738|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Mean Ratio|0.93||||0.37|TWO_SIDED|95.0|0.8|1.09||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Gamma Regression with Log Link Function|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||1.09|0.80|0.37
71937101|NCT04192799|143394739|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Odds Ratio (OR)|1.31||||0.81|TWO_SIDED|95.0|0.14|12.27||Testing was two-sided and p-values \<0.05 were considered statistically significant, not adjusted for multiple comparison.|Regression, Logistic|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||12.27|0.14|0.81
71937102|NCT04192799|143394740|EQUIVALENCE|Testing was two-sided and p-values \<0.05 were considered statistically significant.|Slope|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.11|||Regression, Linear|Adjusted for demographics, clinical characteristics, time period; interaction term for hospital and time period, random effect for practice group.||||0.11|-0.01|0.12
71937103|NCT01151813|143394754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.02|||||||t-test, 2 sided|||||||.02
71937104|NCT01151813|143394755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71937105|NCT01151813|143394756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71937106|NCT01151813|143394757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.04|||||||t-test, 2 sided|||||||0.04
71937107|NCT02917447|143394762|SUPERIORITY|||||||0.15||||||Omnibus test for difference in change from baseline in PCL by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.15
71937108|NCT02917447|143394763|SUPERIORITY|||||||0.049||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||.049
71937109|NCT02917447|143394764|SUPERIORITY|||||||0.92||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.||||||0.92
71937110|NCT03081767|143394768|OTHER||||||<|1e-07||||||Actual P-Value = 3.89597E-42. A P-value of \<0.05 was considered significant.|t-test, 2 sided|||||||<0.0000001
71937111|NCT01399723|143394808|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority between amoxicillin and benzyl penicillin was defined a priori as a risk difference of treatment failure and associated upper bound of the 95% confidence interval (CI) of \<7%. A sample size of 576 would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-0.4|||||TWO_SIDED|95.0|-5.0|4.2|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||4.2|-5.0|
71937112|NCT01399723|143394809|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|0.4|||||TWO_SIDED|95.0|-5.0|5.8|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||5.8|-5.0|
71937113|NCT01399723|143394812|NON_INFERIORITY_OR_EQUIVALENCE|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-3.3|||||TWO_SIDED|95.0|-10.0|3.0|||||Risk difference comparison is for amoxicillin versus benzyl penicillin|||3.0|-10.0|
71937114|NCT03051256|143394816|SUPERIORITY||||||<|0.0122|||||||Mixed Models Analysis|||||||<0.0122
71937115|NCT03051256|143394816|SUPERIORITY||||||<|0.0308|||||||Mixed Models Analysis|||||||<0.0308
71937116|NCT03051256|143394817|SUPERIORITY||||||<|0.0103|||||||Mixed Models Analysis|||||||<0.0103
71937117|NCT03051256|143394817|SUPERIORITY||||||<|0.0039|||||||Mixed Models Analysis|||||||<0.0039
71937118|NCT03051256|143394818|SUPERIORITY|||||||0.1237|||||||Mixed Models Analysis|||||||0.1237
71937119|NCT03051256|143394818|SUPERIORITY|||||||0.1017|||||||Mixed Models Analysis|||||||0.1017
71937120|NCT03051256|143394819|SUPERIORITY||||||<|0.0066|||||||Mixed Models Analysis|||||||<0.0066
71937121|NCT03051256|143394819|SUPERIORITY||||||<|0.0014|||||||Mixed Models Analysis|||||||<0.0014
71937122|NCT03051256|143394820|SUPERIORITY||||||<|0.0245|||||||Mixed Models Analysis|||||||<0.0245
71937123|NCT03051256|143394820|SUPERIORITY||||||<|0.0253|||||||Mixed Models Analysis|||||||<0.0253
71937124|NCT03051256|143394821|SUPERIORITY||||||<|0.0454|||||||Mixed Models Analysis|||||||<0.0454
71937125|NCT03051256|143394821|SUPERIORITY||||||<|0.0043|||||||Mixed Models Analysis|||||||<0.0043
71937126|NCT03051256|143394822|SUPERIORITY|||||||0.0177|||||||Mixed Models Analysis|||||||0.0177
71937127|NCT03051256|143394822|SUPERIORITY|||||||0.0072|||||||Mixed Models Analysis|||||||0.0072
71937128|NCT03051256|143394823|SUPERIORITY|||||||0.0895|||||||Mixed Models Analysis|||||||0.0895
71937129|NCT03051256|143394823|SUPERIORITY|||||||0.0109|||||||Mixed Models Analysis|||||||0.0109
71937130|NCT00294723|143394829|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.62|||<|0.0001||95.0|-0.83|-0.42||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.42|-0.83|<0.0001
71937131|NCT00294723|143394829|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.0014||95.0|-0.53|-0.13||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.13|-0.53|0.0014
71937132|NCT00294723|143394829|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0046||95.0|-0.5|-0.09||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.09|-0.50|0.0046
71937133|NCT00294723|143394830|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.58|||<|0.0001||95.0|-4.28|-2.87||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.87|-4.28|<.0001
71937134|NCT00294723|143394830|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.17|||<|0.0001||95.0|-3.87|-2.47||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.47|-3.87|<.0001
71937135|NCT00294723|143394830|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.41||||0.2584||95.0|-1.11|0.3||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||0.30|-1.11|0.2584
71937136|NCT00294723|143394831|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.65|||<|0.0001||95.0|-4.44|-2.86||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.86|-4.44|<.0001
71937137|NCT00294723|143394831|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.84|||<|0.0001||95.0|-3.63|-2.06||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.06|-3.63|<.0001
71937138|NCT00294723|143394831|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.8||||0.0462||95.0|-1.59|-0.01||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-0.01|-1.59|0.0462
71937139|NCT00294723|143394832|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% confidence interval for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6|||<|0.0001||95.0|-0.83|-0.38||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.38|-0.83|<.0001
71937140|NCT00294723|143394832|NON_INFERIORITY_OR_EQUIVALENCE|The two sided 95% CI for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.31||||0.0076||95.0|-0.54|-0.08||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.08|-0.54|0.0076
71937141|NCT00294723|143394832|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0129||95.0|-0.52|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.52|0.0129
71937142|NCT00294723|143394833|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.48|||<|0.0001||95.0|-4.28|-2.68||2-sided significance level was 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-2.68|-4.28|<0.0001
71692421|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.64|1.65|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.65|0.64|
71937143|NCT00294723|143394833|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.72|||<|0.0001||95.0|-3.52|-1.93||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.||-1.93|-3.52|<0.0001
71937144|NCT00294723|143394833|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.75||||0.0642||95.0|-1.55|0.05||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.||0.05|-1.55|0.0642
71937145|NCT00294723|143394834|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-20.28|||<|0.0001||95.0|-29.09|-11.46||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-11.46|-29.09|<.0001
71937146|NCT00294723|143394834|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-9.92||||0.027||95.0|-18.7|-1.12||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.12|-18.70|0.0270
71937147|NCT00294723|143394834|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-10.36||||0.0223||95.0|-19.24|-1.48||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.48|-19.24|0.0223
71937148|NCT00294723|143394835|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-17.79||||0.0003||95.0|-27.48|-8.09||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-8.09|-27.48|0.0003
71937149|NCT00294723|143394835|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-11.33||||0.0217||95.0|-20.99|-1.66||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-1.66|-20.99|0.0217
71937150|NCT00294723|143394835|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg|Estimated treatment difference, LS Mean|-6.46||||0.1942||95.0|-16.23|3.3||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.30|-16.23|0.1942
71937151|NCT00294723|143394836|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-16.63||||0.0007||95.0|-26.19|-7.06||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-7.06|-26.19|0.0007
71937152|NCT00294723|143394836|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.02||||0.0395||95.0|-19.56|-0.49||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||-0.49|-19.56|0.0395
71937153|NCT00294723|143394836|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1789||95.0|-16.24|3.03||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.||3.03|-16.24|0.1789
71937154|NCT00294723|143394837|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.9||||0.0038||95.0|-21.6|-4.2||2-sided significance level 5%|ANCOVA|||Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-4.2|-21.6|0.0038
71937155|NCT00294723|143394837|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-6.3||||0.1616||95.0|-15.0|2.5||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.5|-15.0|0.1616
71937156|NCT00294723|143394837|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1319||95.0|-15.3|2.0||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||2.0|-15.3|0.1319
71937157|NCT00294723|143394838|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.3||||0.0105||95.0|-21.71|-2.89||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-2.89|-21.71|0.0105
71937158|NCT00294723|143394838|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.49||||0.606||95.0|-11.95|6.98||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||6.98|-11.95|0.6060
71937159|NCT00294723|143394838|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.81||||0.0392||95.0|-19.14|-0.49||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-0.49|-19.14|0.0392
71937160|NCT00294723|143394839|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.98||||0.0227||95.0|-20.42|-1.54||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||-1.54|-20.42|0.0227
71937161|NCT00294723|143394839|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-1.83||||0.7047||95.0|-11.33|7.66||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||7.66|-11.33|0.7047
71937162|NCT00294723|143394839|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.15||||0.0553||95.0|-18.51|0.21||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.||0.21|-18.51|0.0553
71937163|NCT00294723|143394840|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.|Estimated treatment difference, LS Mean|-0.55|||<|0.0001||95.0|-0.77|-0.34||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.34|-0.77|<0.0001
71937164|NCT00294723|143394840|NON_INFERIORITY_OR_EQUIVALENCE|The two-sided 95% confidence interval (CI) for the treatment difference \[liraglutide - glimepiride\] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.28||||0.0122||95.0|-0.49|-0.06||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0122
71937165|NCT00294723|143394840|NON_INFERIORITY_OR_EQUIVALENCE|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.28||||0.0123||95.0|-0.49|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.||-0.06|-0.49|0.0123
71937166|NCT00294723|143394841|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-4.0||||0.1396||95.0|-9.4|1.3||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.3|-9.4|0.1396
71937167|NCT00294723|143394841|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.9||||0.2968||95.0|-8.3|2.5||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.5|-8.3|0.2968
71937168|NCT00294723|143394841|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-1.2||||0.6639||95.0|-6.5|4.1||2-sided significance level 5%|ANCOVA|||Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||4.1|-6.5|0.6639
71937169|NCT00294723|143394842|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.81||||0.172||95.0|-9.28|1.66||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.66|-9.28|0.1720
71937170|NCT00294723|143394842|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.906||95.0|-5.82|5.16||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.16|-5.82|0.9060
71937171|NCT00294723|143394842|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2089||95.0|-8.91|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.91|0.2089
71937172|NCT00294723|143394843|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.04||||0.2749||95.0|-8.51|2.42||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||2.42|-8.51|0.2749
71937173|NCT00294723|143394843|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|0.43||||0.8765||95.0|-5.05|5.92||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||5.92|-5.05|0.8765
71937174|NCT00294723|143394843|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2088||95.0|-8.9|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.||1.95|-8.90|0.2088
71937175|NCT00752791|143394846|SUPERIORITY_OR_OTHER||Mean change from Baseline|0.1|||||TWO_SIDED|95.0|-0.24|0.44|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.|||0.44|-0.24|
71937176|NCT02784106|143394888|SUPERIORITY||Difference in Proportion of Responders|0.1|||||TWO_SIDED|80.0|-0.07|0.25||||||||0.25|-0.07|
71937177|NCT02784106|143394889|SUPERIORITY||Difference in Mean Changes|-1.93|||||TWO_SIDED|80.0|-5.54|1.69||||||||1.69|-5.54|
71937178|NCT02784106|143394890|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||Day 28||0.06|-0.13|
71937179|NCT02784106|143394890|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.18|0.09||||||Day 56||0.09|-0.18|
71937180|NCT02784106|143394890|SUPERIORITY||Difference in Proportion of Responders|-0.01|||||TWO_SIDED|80.0|-0.15|0.12||||||Day 84||0.12|-0.15|
71937181|NCT02784106|143394891|SUPERIORITY||Difference in Proportion of Responders|0.06|||||TWO_SIDED|80.0|0.01|0.14||||||Day 28||0.14|0.01|
71937182|NCT02784106|143394891|SUPERIORITY||Difference in Proportion of Responders|0.03|||||TWO_SIDED|80.0|-0.05|0.11||||||Day 56||0.11|-0.05|
71937183|NCT02784106|143394891|SUPERIORITY||Difference in Proportion of Responders|-0.04|||||TWO_SIDED|80.0|-0.15|0.07||||||Day 84||0.07|-0.15|
71937184|NCT02784106|143394892|SUPERIORITY||Difference in Mean Changes|-1.4|||||TWO_SIDED|80.0|-5.37|2.58||||||||2.58|-5.37|
71937185|NCT02784106|143394893|SUPERIORITY||Difference in Mean Changes|-0.08|||||TWO_SIDED|80.0|-0.33|0.16||||||Day 28||0.16|-0.33|
71937186|NCT02784106|143394893|SUPERIORITY||Difference in Mean Changes|0.07|||||TWO_SIDED|80.0|-0.29|0.43||||||Day 84||0.43|-0.29|
71937187|NCT02784106|143394894|SUPERIORITY||Difference in Proportion of Participants|0.08|||||TWO_SIDED|80.0|-0.04|0.21||||||||0.21|-0.04|
71937188|NCT02784106|143394895|SUPERIORITY||Difference in Proportion of Participants|-0.04|||||TWO_SIDED|80.0|-0.13|0.06||||||||0.06|-0.13|
71937189|NCT02022007|143394922|SUPERIORITY_OR_OTHER|||||||0.007|||||||McNemar|||Study change from dysglycemia to normal glucose state||||.007
71937190|NCT02022007|143394923|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANOVA|||This was a Subjects (SS)/Groups repeated measures design||||.02
71937191|NCT02022007|143394924|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||ANOVA|n||Pretreatment fasting glucose levels were compared with post-treatment levels||||<0.0001
71937192|NCT02022007|143394925|SUPERIORITY_OR_OTHER|||||||0.038|||||||ANOVA|||||||.038
71937193|NCT02022007|143394926|SUPERIORITY_OR_OTHER|||||||0.003|||||||ANOVA|||||||0.003
71692422|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.39|||||TWO_SIDED|95.0|0.87|2.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.24|0.87|
71937194|NCT02022007|143394927|SUPERIORITY_OR_OTHER|||||||0.025|||||||ANOVA|||||||.025
71937195|NCT02022007|143394928|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||0.006
71937196|NCT02022007|143394929|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
71937197|NCT02022007|143394930|SUPERIORITY_OR_OTHER|||||||0.026|||||||ANOVA|||||||.026
71937198|NCT02022007|143394931|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
71937199|NCT02022007|143394932|SUPERIORITY_OR_OTHER|||||||0.006|||||||ANOVA|||||||.006
71937200|NCT02022007|143394933|SUPERIORITY_OR_OTHER||||||>|0.05|||||||Fisher Exact|||||||>0.05
71692423|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.68|1.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.71|0.68|
71692424|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|0.73|||||TWO_SIDED|95.0|0.45|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.45|
71937201|NCT00617461|143394957|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.29||||0.013|TWO_SIDED|90.0|-0.48|-0.1|||ANCOVA|An ANCOVA (repeated measures mixed model) with body mass index, baseline 24-hr average pain intensity, and grouped center as covariates was used.||||-0.10|-0.48|0.013
71937202|NCT00457665|143394975|SUPERIORITY|||||||0.94|||||||Mixed Models Analysis|||||||0.94
71937203|NCT01851590|143394986|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Proportions and 95% confidence intervals (CIs) were calculated for negative KOH staining, negative cultures, and a combination of these at 4- and 10-month time points. Cochran-Mantel-Haenszel and χ2-tests were used to analyse efficacy criteria.|Cochran-Mantel-Haenszel|||The sample size was estimated according to complete mycological cure at 10 months. Estimation was based on the design of a binary-outcome head-to-head superiority trial. Orally administered terbinafine treatment was considered the active control. Approximately 25 patients / arm were required to have 80% power (β=0.2) at a two-sided α=0.05 significance level to detect a decrease in primary outcome from 50% in the terbinafine arm to 15% in the amorolfine or resin lacquer treatment arms.||||<0.05
71937204|NCT01851590|143394987|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
71692425|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.53|2.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.52|0.53|
71692426|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.8|||||TWO_SIDED|95.0|0.9|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.62|0.90|
71937205|NCT01851590|143394988|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
71937206|NCT01851590|143394989|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni's post hoc test.|ANOVA|||||||<0.05
71937207|NCT01851590|143394990|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|||||Qualitative data are expressed as frequencies and percentages, and differences between parallel groups were compared with the χ2-test or Fisher's exact test, as appropriate.|Chi-squared|||||||<0.05
71937208|NCT00891878|143395019|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
71937209|NCT00891878|143395020|SUPERIORITY|||||||0.45|||||||Fisher Exact|||||||0.45
71937210|NCT01199601|143395029|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.12|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.23|||Regression, Linear|Information provided for crude analysis results; adjustment for significant baseline differences between groups did not change results substantially.||Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||1.23|1.02|<0.05
71937211|NCT01199601|143395030|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|1.1|STANDARD_DEVIATION|0.05|<|0.05|TWO_SIDED|95.0|1.02|1.18|||Regression, Linear|Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.||||1.18|1.02|<0.05
71937212|NCT01199601|143395031|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|STANDARD_DEVIATION|0.05||0.05|TWO_SIDED|95.0|1.01|1.25|||Regression, Logistic|The crude analysis result is provided as the odds ratio did not change substantially when adjusted for possible confounders.||||1.25|1.01|0.05
71937213|NCT01688037|143395062|OTHER||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.8||0.2966|TWO_SIDED|95.0|-2.3|0.7|||ANCOVA|||||0.7|-2.3|0.2966
71937214|NCT01688037|143395063|OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.2||0.743|TWO_SIDED|95.0|-0.3|0.4|||ANOVA|||||0.4|-0.3|0.743
71937215|NCT01688037|143395064|OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1151|TWO_SIDED|95.0|-0.7|0.1|||ANOVA|||||0.1|-0.7|0.1151
71937216|NCT01688037|143395064|OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0277|TWO_SIDED|95.0|-0.8|0.0|||ANOVA|||||0.0|-0.8|0.0277
71937217|NCT02100956|143395074|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||Null hypothesis was that there was no difference in VAS pain scale scores after intrathecal study drug injection between oxytocin and placebo. To account for repeated measures across time and drug conditions, VAS apin scale scores were analyzed using a linear mixed-effects model with random intercepts at the level of participant. Each outcome was regressed on fixed-effects for order of study day, study drug, time after injection, and drug x time interaction.||||<0.05
71937218|NCT02473991|143395076|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.||||<0.01
71937219|NCT02473991|143395077|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.||||<0.01
71937220|NCT03065283|143395087|EQUIVALENCE|p\< or = 0.05|Mean Difference (Final Values)|0.09||||0.05|TWO_SIDED|95.0|-0.38|0.57|||t-test, 2 sided|||A paired t-test was used for intragroup analysis, and an independent Student's t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.||0.57|-0.38|0.05
71937221|NCT00095199|143395091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.756|TWO_SIDED|95.0|0.87|1.21||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.21|0.87|0.756
71937222|NCT00095199|143395091|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.391|TWO_SIDED|95.0|0.73|1.13||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.13|0.73|0.391
71937223|NCT00095199|143395092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.01||||0.864|TWO_SIDED|95.0|0.86|1.2||The 2-sided unstratified log-rank test was employed at the 5% significance level|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.20|0.86|0.864
71937224|NCT00095199|143395092|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.13||||0.307|TWO_SIDED|95.0|0.9|1.41||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.41|0.90|0.307
71937225|NCT00095199|143395093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.59||||0.2|TWO_SIDED|95.0|0.78|3.26||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.26|0.78|0.200
71937226|NCT00095199|143395093|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.683|TWO_SIDED|95.0|0.52|2.74||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.74|0.52|0.683
71937227|NCT00095199|143395094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.18||||0.31|TWO_SIDED|95.0|0.86|1.62||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.62|0.86|0.310
71937228|NCT00095199|143395094|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.1|TWO_SIDED|95.0|0.93|2.4||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.40|0.93|0.100
71937229|NCT00095199|143395095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7||||0.091|TWO_SIDED|95.0|0.46|1.06||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.06|0.46|0.091
71937230|NCT00095199|143395095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34||||0.361|TWO_SIDED|95.0|0.72|2.5||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.50|0.72|0.361
71937231|NCT00095199|143395096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.472|TWO_SIDED|95.0|0.77|1.74||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.74|0.77|0.472
71937232|NCT00095199|143395096|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.73||||0.272|TWO_SIDED|95.0|0.42|1.27||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||1.27|0.42|0.272
71937233|NCT00095199|143395097|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.58||||0.236|TWO_SIDED|95.0|0.74|3.36||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||3.36|0.74|0.236
71937234|NCT00095199|143395097|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.887|TWO_SIDED|95.0|0.42|2.18||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR\<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.||2.18|0.42|0.887
71937235|NCT01070394|143395104|SUPERIORITY_OR_OTHER||||||<|0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.001
71937236|NCT01070394|143395105|SUPERIORITY_OR_OTHER|||||||0.569|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.569
71937237|NCT01070394|143395105|SUPERIORITY_OR_OTHER|||||||0.827|||||||Generalized Estimating Equation|||The following p-value is for AMSES In-Clinic, a subset of the overall AMSES||||.827
71937238|NCT01070394|143395105|SUPERIORITY_OR_OTHER|||||||0.569|||||||Generalized Estimating Equation|||The following p-value is for AMSES, Evening, a subset of the AMSES||||.569
71937239|NCT01070394|143395106|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||.001
71937240|NCT01070394|143395107|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED||||||GEE regression model|||||||<.001
71937241|NCT01070394|143395108|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||GEE regression model|Generalized Estimating Equation (GEE)||||||<.0001
71937242|NCT01070394|143395109|SUPERIORITY_OR_OTHER|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)||||||0.001
71937243|NCT03280537|143395126|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.23||0.014|TWO_SIDED|95.0|-1.05|-0.12||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.12|-1.05|0.0140
71937244|NCT03280537|143395127|SUPERIORITY||Difference in Least Squares Means|-0.5|STANDARD_ERROR_OF_MEAN|0.15||0.0017|TWO_SIDED|95.0|-0.8|-0.19||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.||-0.19|-0.80|0.0017
71937245|NCT03280537|143395128|SUPERIORITY||Difference in Least Squares Means|-0.45|STANDARD_ERROR_OF_MEAN|0.14||0.0024|TWO_SIDED|95.0|-0.73|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.||-0.16|-0.73|0.0024
71937246|NCT03280537|143395129|SUPERIORITY||Difference in Least Squares Means|-0.54|STANDARD_ERROR_OF_MEAN|0.14||0.0001|TWO_SIDED|95.0|-0.81|-0.27||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.||-0.27|-0.81|0.0001
71937247|NCT03280537|143395130|SUPERIORITY||Difference in Least Squares Means|-0.91|STANDARD_ERROR_OF_MEAN|0.24||0.0002|TWO_SIDED|95.0|-1.39|-0.44||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.||-0.44|-1.39|0.0002
71937248|NCT03280537|143395131|SUPERIORITY||Difference in Least Squares Means|-0.59|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.87|-0.3||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.||-0.30|-0.87|<0.0001
71937249|NCT03280537|143395132|SUPERIORITY||Difference in Least Squares Means|-15.04|STANDARD_ERROR_OF_MEAN|3.14|<|0.0001|TWO_SIDED|95.0|-21.26|-8.82||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.||-8.82|-21.26|<0.0001
71937250|NCT03280537|143395133|SUPERIORITY||Difference in Least Squares Means|-0.63|STANDARD_ERROR_OF_MEAN|0.14|<|0.0001|TWO_SIDED|95.0|-0.9|-0.35||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.||-0.35|-0.90|<0.0001
71692427|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.65|||||TWO_SIDED|95.0|0.84|3.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.23|0.84|
71937251|NCT03280537|143395134|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.||1.89|0.02|0.1594
71937252|NCT03280537|143395135|SUPERIORITY||Odds Ratio (OR)|0.0||||1|TWO_SIDED|95.0|0.0|20.61||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.||20.61|0.00|1.0000
71937253|NCT03280537|143395136|SUPERIORITY||Odds Ratio (OR)|4.04||||0.0396|TWO_SIDED|95.0|1.07|15.25|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.||15.25|1.07|0.0396
71937254|NCT03280537|143395137|SUPERIORITY||Odds Ratio (OR)|0.2||||0.1594|TWO_SIDED|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.||1.89|0.02|0.1594
71937255|NCT03280537|143395138|SUPERIORITY||Odds Ratio (OR)|6.22||||0.0139|TWO_SIDED|95.0|1.23|60.23||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.||60.23|1.23|0.0139
71937256|NCT03280537|143395139|SUPERIORITY||Difference in Least Squares Means|-2.09|STANDARD_ERROR_OF_MEAN|0.46|<|0.0001|TWO_SIDED|95.0|-3.0|-1.18||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.||-1.18|-3.00|<0.0001
71937257|NCT03280537|143395140|SUPERIORITY||Difference in Least Squares Means|3.86|STANDARD_ERROR_OF_MEAN|1.16||0.0011|TWO_SIDED|95.0|1.57|6.15||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.||6.15|1.57|0.0011
71937258|NCT00634283|143395149|SUPERIORITY|||||||0.55|||||||t-test, 2 sided|||||||0.55
71937259|NCT00634283|143395149|SUPERIORITY|||||||0.32||||||The a priori threshold was set at 0.05, 2-tailed, without adjustment for multiple comparisons.|t-test, 2 sided|||Change in PFC over the one-week placebo lead-in period was compared between antidepressant-experienced and antidepressant-naive groups using a between groups t-test.|"Group differences in PFC changes over time during administration of venlafaxine were assessed using mixed-model analysis.~we compared brain functional changes over the course of venlafaxine treatment between antidepressant-experienced and antidepressant-naïve subjects using linear mixed model analysis (random intercept model) conducted using full maximum likelihood estimation (MLE). Changes in PFC were calculated from the end of placebo lead-in to 48 hours, and 1, 2, and 4 weeks, yielding a within-group factor of time with four levels. We employed a first-order autoregressive covariance structure to reflect our assumption that PFC measurements closer together in time would be more highly correlated."|||0.32
71937260|NCT03118739|143395162|SUPERIORITY||Mean % Change from Baseline|-39.37|||||TWO_SIDED|90.0|-61.785|-3.814||||||||-3.814|-61.785|
71937261|NCT01144663|143395283|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|0.01|||||TWO_SIDED|95.0|-1.17|1.2||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference \[Nimenrix 3 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||1.2|-1.17|
71937262|NCT01144663|143395283|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percenttage|-0.43|||||TWO_SIDED|95.0|-1.57|0.4||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 3 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.4|-1.57|
71937263|NCT01144663|143395283|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-0.88|||||TWO_SIDED|95.0|-2.45|0.43||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus Menjugate Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||0.43|-2.45|
71937264|NCT01144663|143395283|NON_INFERIORITY|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-1.32|||||TWO_SIDED|95.0|-2.84|-0.48||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference \[Nimenrix 2 Group minus NeisVac-C Group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.||-0.48|-2.84|
71937265|NCT01335477|143395331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|93.73|STANDARD_ERROR_OF_MEAN|24.907||0.0002||95.0|44.78|142.68||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix.~Nintedanib 150 mg bid versus Placebo."|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."||142.68|44.78|0.0002
71937266|NCT01335477|143395332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.69|STANDARD_ERROR_OF_MEAN|1.151||0.0197||95.0|-4.95|-0.43|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.||-0.43|-4.95|0.0197
71937267|NCT01335477|143395333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.005||95.0|0.19|0.77|||Log Rank||Nintedanib 150 mg bid versus Placebo.|Hazard Ratio is based on a Cox's regression model with terms for treatment, gender, age and height.||0.77|0.19|0.0050
71937268|NCT01335477|143395334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|109.77|STANDARD_ERROR_OF_MEAN|19.808|<|0.0001||95.0|70.92|148.62|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||148.62|70.92|<0.0001
71937269|NCT01335477|143395335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.24|STANDARD_ERROR_OF_MEAN|0.742|<|0.0001||95.0|2.78|5.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.||5.69|2.78|<0.0001
71937270|NCT01335477|143395336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|0.607|<|0.0001||95.0|1.87|4.25|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||4.25|1.87|<0.0001
71937271|NCT01335477|143395337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.21|STANDARD_ERROR_OF_MEAN|0.743|<|0.0001||95.0|2.76|5.67|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC \[%predicted\], baseline FVC \[%predicted\]-by-visit and random effect for patient.||5.67|2.76|<0.0001
71937272|NCT01335477|143395340|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.286||||0.1833||95.0|0.89|1.86|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted||1.86|0.89|0.1833
71937273|NCT01335477|143395341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.794||||0.0011||95.0|1.26|2.55|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted.||2.55|1.26|0.0011
71937274|NCT01335477|143395342|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.664||||0.0218||95.0|1.08|2.57|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score||2.57|1.08|0.0218
71937275|NCT01335477|143395343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|1.675||0.4019||95.0|-4.69|1.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.||1.88|-4.69|0.4019
71937276|NCT01335477|143395344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.08|STANDARD_ERROR_OF_MEAN|1.342||0.022||95.0|-5.71|-0.45|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ impact component-by-visit and random effect for patient||-0.45|-5.71|0.0220
71937277|NCT01335477|143395345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.31|STANDARD_ERROR_OF_MEAN|1.36||0.0152||95.0|-5.97|-0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient||-0.64|-5.97|0.0152
71937278|NCT01335477|143395346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.12|STANDARD_ERROR_OF_MEAN|1.192||0.0089||95.0|-5.46|-0.79|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.||-0.79|-5.46|0.0089
71937279|NCT01335477|143395347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.38|STANDARD_ERROR_OF_MEAN|1.685||0.1587||95.0|-5.68|0.93|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.||0.93|-5.68|0.1587
71937280|NCT01335477|143395348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.05|STANDARD_ERROR_OF_MEAN|1.713||0.2326||95.0|-1.31|5.41|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.||5.41|-1.31|0.2326
71937281|NCT01335477|143395349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.81|STANDARD_ERROR_OF_MEAN|1.564||0.2475||95.0|-1.26|4.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.||4.88|-1.26|0.2475
71937282|NCT01335477|143395350|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.379||||0.069||95.0|0.98|1.95|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with term treatment||1.95|0.98|0.0690
71937283|NCT01335477|143395352|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.38||||0.007||95.0|0.19|0.77|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150 mg bid versus Placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.||0.77|0.19|0.0070
71937284|NCT01335477|143395353|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.74||||0.2995||95.0|0.4|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.40|0.2995
71937285|NCT01335477|143395354|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.6654||95.0|0.39|1.9|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.90|0.39|0.6654
71937286|NCT01335477|143395355|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.68||||0.2209||95.0|0.34|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.||1.35|0.34|0.2209
71937287|NCT01335477|143395356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.1664||95.0|0.37|1.21|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.21|0.37|0.1664
71937288|NCT01335477|143395357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.8||||0.2123||95.0|0.55|1.16|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.||1.16|0.55|0.2123
71937289|NCT01335477|143395358|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.213||0.2032||95.0|-0.15|0.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.||0.69|-0.15|0.2032
71937290|NCT01335477|143395359|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.113|STANDARD_ERROR_OF_MEAN|0.1005||0.26||95.0|-0.084|0.31|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) \[mmol/min/kPa\], baseline DLCO (HGB Corrected) \[mmol/min/kPa\]-by-visit and random effect for patient.||0.310|-0.084|0.2600
71937291|NCT03031899|143395364|NON_INFERIORITY|"1. Rose bengal should stain the areas positively stained by Toluidine blue~2. areas stained by rose bengal that shows dysplasia in biopsy"|SN, SP, PPV, NPV|||||0.005|||||||Chi-squared|||||||0.005
71937292|NCT01469364|143395368|SUPERIORITY_OR_OTHER|||||||0.203|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2030
71937293|NCT01469364|143395369|SUPERIORITY_OR_OTHER|||||||0.2527|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.2527
71937294|NCT01469364|143395374|SUPERIORITY_OR_OTHER||Mean Absolute Difference|-1.52||||0.34|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 PCS||||0.34
71937295|NCT01469364|143395374|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.78||||0.18|TWO_SIDED||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 MCS||||0.18
71937296|NCT01469364|143395375|SUPERIORITY_OR_OTHER||Median Absolute Difference|1.62||||0.09|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 PCS||||0.09
71937297|NCT01469364|143395375|SUPERIORITY_OR_OTHER||Median Absolute Difference|-1.24||||0.31|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 MCS||||0.31
71937298|NCT01469364|143395376|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.82||||0.56|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ measure||||0.56
71937299|NCT01469364|143395377|SUPERIORITY_OR_OTHER||Median Absolute Difference|0.15||||0.68|TWO_SIDED||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ Measure||||0.68
71937300|NCT01469364|143395378|SUPERIORITY_OR_OTHER|||||||0.7454|TWO_SIDED||||||t-test, 2 sided|Paired t-test 2 sided.||||||0.7454
71937301|NCT01469364|143395379|SUPERIORITY_OR_OTHER|||||||0.9638|TWO_SIDED||||||t-test, 2 sided|Paired t-test was completed.||||||0.9638
71937302|NCT02040428|143395406|SUPERIORITY_OR_OTHER|||||||0.0001|ONE_SIDED||||||Adaptive group sequential design|Whitehead method for triangular test||Superiority||||0.0001
71937303|NCT02040428|143395407|SUPERIORITY_OR_OTHER|||||||0.0046|TWO_SIDED||||||Chi-squared|||||||0.0046
71937304|NCT00992264|143395410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88|||||TWO_SIDED|95.0|0.51|1.51|||||OR for smoking abstinence at 12 months in intent to treat sample. Participants receiving content written in a Prescriptive tone were compared against persons receiving content in a Motivational tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.51|0.51|
71937305|NCT00992264|143395410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.12|||||TWO_SIDED|95.0|0.66|1.91|||||OR for smoking abstinence at 12 months when persons who randomly received a Testimonial were compared against persons receiving No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.91|0.66|
71937306|NCT00992264|143395410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.7|2.02|||||OR for smoking abstinence at 12 months when persons assigned to Dictated navigation were compared to those not assigned to Dictated navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||2.02|0.70|
71937307|NCT00992264|143395410|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|||||TWO_SIDED|95.0|0.43|1.3|||||OR for smoking abstinence at 12 months when persons assigned to receive Proactive Email reminders were compared against persons who received No Emails (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.30|0.43|
71937308|NCT00992264|143395411|SUPERIORITY_OR_OTHER||Odds Ratio, log|0.94|||||TWO_SIDED|95.0|0.62|1.43|||||OR for use of adjunct treatment at 12 months when persons assigned to Prescriptive Tone were compared to persons assigned to receive content in a Motivational Tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).||1.43|0.62|
71937309|NCT00992264|143395411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.46|1.07|||||OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).||1.07|0.46|
71937310|NCT00992264|143395411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78|||||TWO_SIDED|95.0|0.51|1.18|||||OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).||1.18|0.51|
71937311|NCT00992264|143395411|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67|||||TWO_SIDED|95.0|0.44|1.03|||||OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).||1.03|0.44|
71937312|NCT00449072|143395427|SUPERIORITY_OR_OTHER||Difference (LS Mean)|-0.45||||0.0096|TWO_SIDED|95.0|-0.78|-0.11|||ANCOVA|The treatment arm, age group (at Visit 1) and sex were fixed effects, and baseline growth velocity was a covariate in the ANCOVA model||||-0.11|-0.78|0.0096
71937313|NCT00449072|143395428|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.12||||0.7341|TWO_SIDED|95.0|-0.83|0.58|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|||0.58|-0.83|0.7341
71937314|NCT00449072|143395429|SUPERIORITY_OR_OTHER||LS Mean Differerence|-0.15||||0.1963|TWO_SIDED|95.0|-0.37|0.08|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in nasal stuffiness||0.08|-0.37|0.1963
71937315|NCT00449072|143395429|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.04||||0.7193|TWO_SIDED|95.0|-0.24|0.17|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Discharge||0.17|-0.24|0.7193
71937316|NCT00449072|143395429|SUPERIORITY_OR_OTHER||LS Mean Difference|0.09||||0.402|TWO_SIDED|95.0|-0.12|0.29|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Sneezing||0.29|-0.12|0.4020
71937317|NCT00449072|143395429|SUPERIORITY_OR_OTHER||LS mean Difference|-0.02||||0.8854|TWO_SIDED|95.0|-0.23|0.2|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Itching||0.20|-0.23|0.8854
71937318|NCT00449072|143395430|SUPERIORITY_OR_OTHER|||||||0.0951||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.0951
71937319|NCT00449072|143395430|SUPERIORITY_OR_OTHER|||||||0.1247||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 240||||0.1247
71937320|NCT00449072|143395430|SUPERIORITY_OR_OTHER|||||||0.0207||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 360||||0.0207
71937321|NCT00449072|143395431|SUPERIORITY_OR_OTHER|||||||0.2445||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120||||0.2445
71937322|NCT00449072|143395431|SUPERIORITY_OR_OTHER|||||||0.4488||95.0|||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 240||||0.4488
71937323|NCT00449072|143395431|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.|Mixed model for repeated measures|||Statistical Analysis for Day 360||||0.0142
71937324|NCT01798485|143395469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111||||0.3293|TWO_SIDED|95.0|0.899|1.372|||Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.||1.372|0.899|0.3293
71937325|NCT01798485|143395469|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.111|||||TWO_SIDED|99.5|0.821|1.503||||||"Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.~Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region)."||1.503|0.821|
71937326|NCT01798485|143395470|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.161||||0.118|TWO_SIDED|95.0|0.961|1.403||Significance level of 0.05.|Log Rank|Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.||||1.403|0.961|0.1180
71937327|NCT01798485|143395471|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.232||||0.2506|TWO_SIDED|95.0|0.865|1.754||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.754|0.865|0.2506
71937328|NCT01798485|143395472|SUPERIORITY_OR_OTHER|||||||0.448|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.448
71937329|NCT01798485|143395473|SUPERIORITY_OR_OTHER|||||||0.339|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 6 weeks||||0.339
71937330|NCT01798485|143395473|SUPERIORITY_OR_OTHER|||||||0.817|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||\>= 12 weeks||||0.817
71937331|NCT01798485|143395474|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.344||||0.0111|TWO_SIDED|95.0|1.207|4.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||4.551|1.207|0.0111
71937332|NCT01798485|143395475|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.112||||0.5191|TWO_SIDED|95.0|0.797|1.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).||||1.551|0.797|0.5191
71937333|NCT01798485|143395478|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.233||||0.1343|TWO_SIDED|95.0|0.937|1.621||Significance level of 0.05.|Log Rank|Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||||1.621|0.937|0.1343
71937334|NCT01798485|143395479|SUPERIORITY_OR_OTHER|||||||0.25|TWO_SIDED|||||Significance level of 0.05.|Fisher Exact|||||||0.250
71937335|NCT01333033|143395526|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71937336|NCT01992107|143395548|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.03|||||TWO_SIDED|95.0|0.93|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N1||1.14|0.93|
71937337|NCT01992107|143395548|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.05|||||TWO_SIDED|95.0|0.97|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2||1.14|0.97|
71937338|NCT01992107|143395548|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|0.99|||||TWO_SIDED|95.0|0.89|1.1|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1||1.1|0.89|
71937339|NCT01992107|143395548|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2||1.14|0.87|
71937340|NCT01992107|143395549|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|2.0|||||TWO_SIDED|95.0|-2.5|6.9|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N1||6.9|-2.5|
71937341|NCT01992107|143395549|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|4.0|||||TWO_SIDED|95.0|-1.4|9.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N2||9.2|-1.4|
71937342|NCT01992107|143395549|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|0.0|||||TWO_SIDED|95.0|-5.5|4.5|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1||4.5|-5.5|
71937343|NCT01992107|143395549|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|-2.0|||||TWO_SIDED|95.0|-6.5|3.2|||ANCOVA|||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2||3.2|-6.5|
71937344|NCT01992107|143395555|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.25|||||TWO_SIDED|95.0|0.22|0.29||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.29|0.22|
71937345|NCT01992107|143395556|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-47.0|||||TWO_SIDED|95.0|-51.1|-42.1||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-42.1|-51.1|
71937346|NCT01992107|143395557|SUPERIORITY_OR_OTHER||Ratios of GMT (Day 22/Day 50)|0.38|||||TWO_SIDED|95.0|0.35|0.42||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.||0.42|0.35|
71937347|NCT01992107|143395558|SUPERIORITY_OR_OTHER||Difference b/w SC rates(Day 22/Day 50)|-34.0|||||TWO_SIDED|95.0|-38.8|-29.3||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c - %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.||-29.3|-38.8|
71937348|NCT01288859|143395564|NON_INFERIORITY_OR_EQUIVALENCE|The results from LC-MS/MS analysis of parent polyphenols were analyzed and expressed as the absolute changes from the baseline to reduce possible effects of inter-subject fasting variability|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.1||0.02|TWO_SIDED|95.0|||||ANOVA|||||||0.02
71937349|NCT01288859|143395565|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.01||0.01|TWO_SIDED|95.0|||||ANOVA|||Statistical analysis was performed using the statistical package SPSS for Windows (version15). By the analysis of variance (ANOVA) for repeated measures the subjective time curves for all measured compounds were compared and tested for the effect of treatment and of time as factors. For all tests, following a significant main effect in the ANOVA, individual means were compared using the Bonferroni test (p \< 0.05). Results were considered significant at p \< 0.05.||||0.01
71937350|NCT01288859|143395566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.01||0.04|TWO_SIDED|95.0|||||ANOVA|||||||0.04
71937351|NCT02444533|143395646|SUPERIORITY|||||||0.043|||||||t-test, 2 sided|||Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.||||0.043
71937352|NCT02444533|143395646|SUPERIORITY|||||||0.445|||||||t-test, 2 sided|||Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.||||0.445
71937353|NCT02444533|143395647|SUPERIORITY|||||||0.65|||||||t-test, 2 sided|||Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.||||0.650
71937354|NCT02444533|143395647|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.||||0.970
71937355|NCT02444533|143395647|SUPERIORITY|||||||0.835|||||||t-test, 2 sided|||Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.||||0.835
71937356|NCT02444533|143395648|SUPERIORITY|||||||1|||||||t-test, 2 sided|||Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.||||1.0
71692428|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.17|||||TWO_SIDED|95.0|0.58|2.35|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||2.35|0.58|
71937357|NCT05085613|143395737|SUPERIORITY||Mean Difference (Final Values)|0.6279928|STANDARD_ERROR_OF_MEAN|4.150369||0.998|TWO_SIDED|95.0|-9.463627|10.71961||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF=6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||10.71961|-9.463627|0.998
71937358|NCT05085613|143395737|SUPERIORITY||Mean Difference (Final Values)|4.044194|STANDARD_ERROR_OF_MEAN|4.302202||0.725|TWO_SIDED|95.0|-6.416608|14.505||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.505|-6.416608|0.725
71937359|NCT05085613|143395737|SUPERIORITY||Mean Difference (Final Values)|-1.53656|STANDARD_ERROR_OF_MEAN|-1.53656||0.98|TWO_SIDED|95.0|-12.25295|9.179834||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||9.179834|-12.25295|0.980
71937360|NCT05085613|143395738|SUPERIORITY||Mean Difference (Final Values)|7.002255|STANDARD_ERROR_OF_MEAN|8.801527||0.813|TWO_SIDED|95.0|-14.39448|28.39899||Sidak's adjusted p-value for multiple comparisons|ANCOVA|Df = 6|Economic recovery condition - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||28.39899|-14.39448|0.813
71692429|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.46|||||TWO_SIDED|95.0|0.71|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.97|0.71|
71937361|NCT05085613|143395738|SUPERIORITY||Mean Difference (Final Values)|15.12214|STANDARD_ERROR_OF_MEAN|9.07444||0.268|TWO_SIDED|95.0|-6.938055|37.18234||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.18234|-6.938055|0.268
71937362|NCT05085613|143395738|SUPERIORITY||Mean Difference (Final Values)|14.4032|STANDARD_ERROR_OF_MEAN|9.305576||0.33|TWO_SIDED|95.0|-8.218891|37.0253||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||37.0253|-8.218891|0.330
71937363|NCT05085613|143395739|SUPERIORITY||Mean Difference (Final Values)|-1.457003|STANDARD_ERROR_OF_MEAN|6.380984||0.994|TWO_SIDED|95.0|-16.98852|14.07451||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||14.07451|-16.98852|0.994
71937364|NCT05085613|143395739|SUPERIORITY||Mean Difference (Final Values)|-1.097586|STANDARD_ERROR_OF_MEAN|6.675066||0.998|TWO_SIDED|95.0|-17.34491|15.14973||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||15.14973|-17.34491|0.998
71937365|NCT05085613|143395739|SUPERIORITY||Mean Difference (Final Values)|8.926191|STANDARD_ERROR_OF_MEAN|6.588643||0.447|TWO_SIDED|95.0|-7.110771|24.96315||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 5|Humor - Control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||24.96315|-7.110771|0.447
71937366|NCT05085613|143395740|SUPERIORITY||Mean Difference (Final Values)|-4.154612|STANDARD_ERROR_OF_MEAN|1.986723||0.113|TWO_SIDED|95.0|-8.985328|0.6761041||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Economic recovery - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||.6761041|-8.985328|0.113
71937367|NCT05085613|143395740|SUPERIORITY||Mean Difference (Final Values)|-2.685896|STANDARD_ERROR_OF_MEAN|2.046067||0.473|TWO_SIDED|95.0|-7.6609|2.289114||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Freedom - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||2.289114|-7.66090|0.473
71937368|NCT05085613|143395740|SUPERIORITY||Mean Difference (Final Values)|-6.469932|STANDARD_ERROR_OF_MEAN|2.102231||0.008|TWO_SIDED|95.0|-11.58151|-1.358358||Sidak's adjusted p-value for multiple comparisons|ANCOVA|DF = 6|Humor - control|Note that analyses are underpowered due to administrative issues with funding that halted recruitment early.||-1.358358|-11.58151|0.008
71937369|NCT00952484|143395741|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value based on Wilcoxon rank sum test comparing the median RGI-C score for the asfotase alfa combined reporting group to the historical control group.|Wilcoxon (Mann-Whitney)|||||||0.0007
71937370|NCT00952484|143395742|SUPERIORITY_OR_OTHER|||||||0.0097|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0097
71937371|NCT00952484|143395743|SUPERIORITY_OR_OTHER|||||||0.0789|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0789
71937372|NCT00952484|143395744|SUPERIORITY_OR_OTHER|||||||0.7417|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.7417
71937373|NCT00952484|143395745|SUPERIORITY_OR_OTHER|||||||0.757|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a Wilcoxon Signed-Rank test.|Wilcoxon Signed-Rank|||||||0.7570
71937374|NCT00952484|143395746|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||<0.0001
71937375|NCT00952484|143395747|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED|||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided|||||||0.0007
71937376|NCT02422290|143395754|SUPERIORITY||Mean Difference (Final Values)|1.53|STANDARD_ERROR_OF_MEAN|1.83||0.2|TWO_SIDED|95.0|-2.27|7.87|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CY-BOCS scores at the time points Baseline and Day 14.||7.87|-2.27|.20
71937377|NCT02422290|143395755|SUPERIORITY||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|0.49||0.18|TWO_SIDED|95.0|-0.56|2.16|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between CGI-S scores at the time points Baseline and Day 14.||2.16|-.56|.18
71937378|NCT02422290|143395756|SUPERIORITY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|1.0||1|TWO_SIDED|95.0|-2.78|2.78|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||2.78|-2.78|1.00
71937379|NCT02422290|143395757|SUPERIORITY||Mean Difference (Final Values)|0.32|STANDARD_ERROR_OF_MEAN|5.41||0.77|TWO_SIDED|95.0|-15.46|18.96|||t-test, 2 sided|||Paired sample t-test was calculated to test mean difference between OCD-VAS scores at the time points Baseline and Day 14.||18.96|-15.46|.77
71937380|NCT01842958|143395770|NON_INFERIORITY|The test arm will be considered non-inferior to the control arm if the 95% upper confidence interval of the estimated difference between the test and control arms is less than -0.5mm.||||||0.02|||||||ANCOVA|||The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.||||0.02
71937381|NCT00818623|143395784|SUPERIORITY_OR_OTHER_LEGACY|||||||5.86e-05||95.0|||||Log Rank|||||||0.0000586
71937382|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0014||95.0|||||Kruskal-Wallis|||||||0.0014
71937383|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|87.5||||||95.0|66.1|95.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||95.8|66.1|
71937384|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|66.7||||||95.0|33.7|86.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||86|33.7|
71937385|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|54.5||||||95.0|22.9|78.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78|22.9|
71937386|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|100.0||||||95.0|85.8|100.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||100|85.8|
71937387|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|75.0||||||95.0|52.6|87.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||87.9|52.6|
71937388|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|95.7||||||95.0|72.9|99.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||99.4|72.9|
71937389|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|62.5||||||95.0|40.3|78.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||78.4|40.3|
71937390|NCT00818623|143395785|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|88.9||||||95.0|69.4|96.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.||96.3|69.4|
71937391|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0031||95.0|||||Kruskal-Wallis|||||||0.0031
71937392|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|45.8||||||95.0|25.6|64.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64|25.6|
71937393|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|38.1||||||95.0|12.1|64.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||64.3|12.1|
71937394|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|32.7||||||95.0|8.3|60.6||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||60.6|8.3|
71937395|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|83.3||||||95.0|61.5|93.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||93.4|61.5|
71937396|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|49.4||||||95.0|28.3|67.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.4|28.3|
71937397|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|82.0||||||95.0|58.8|92.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||92.8|58.8|
71937398|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|50.0||||||95.0|29.1|67.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||67.8|29.1|
71937399|NCT00818623|143395786|SUPERIORITY_OR_OTHER_LEGACY||Percentage of participants castrated|70.4||||||95.0|49.4|83.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.||83.9|49.4|
71937400|NCT00818623|143395787|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0866||95.0|||||Log Rank|||||||0.0866
71937401|NCT00818623|143395788|SUPERIORITY_OR_OTHER_LEGACY|||||||0.033||95.0|||||Log Rank|||||||0.033
71937402|NCT00818623|143395789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.131||95.0|||||Log Rank|||||||0.131
71937403|NCT00602030|143395793|SUPERIORITY||Adjusted Odds Ratio|0.72||||0.505|TWO_SIDED|95.0|0.27|1.89|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel estimation of odds ratio adjusted for the smoking history stratification factor, using placebo as reference group.|||1.89|0.27|0.505
71937404|NCT00602030|143395794|SUPERIORITY||Adjusted Odds Ratio|0.31||||0.13|TWO_SIDED|95.0|0.06|1.54|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group .|||1.54|0.06|0.13
71937405|NCT00602030|143395795|SUPERIORITY||Adjusted Odds Ratio|1.06||||0.918|TWO_SIDED|95.0|0.34|3.27|||Cochran-Mantel-Haenszel||Estimation of odds ratio was adjusted for the smoking history stratification factor, using placebo as reference group.|||3.27|0.34|0.918
71937406|NCT02649231|143395826|SUPERIORITY||Odds Ratio (OR)|0.7|||||TWO_SIDED|95.0|0.28|1.75||||||Confirmed alcohol relapse by drug condition at 6 months using the Alcohol Timeline-Followback. Logistic regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and alcohol education).||1.75|0.28|
71937407|NCT02649231|143395827|SUPERIORITY||Mean Difference (Final Values)|10.1|||||TWO_SIDED|95.0|1.1|19.0||||||Linear regression modelling was used to compare the ketamine group with the placebo group (combined across therapy and psychoeducation). Only participants with a minimum of 159 days of completed drinking self-report data were included in the main ITT analysis as this was the shortest duration of time before any participant completed the 6 month (23-25 week) follow up in the study. Reporting time was capped at 180 days.||19.0|1.1|
71937408|NCT00319956|143395841|SUPERIORITY|||||||0.2|||||||Chi-squared|||||||0.20
71937409|NCT02607800|143395849|NON_INFERIORITY|Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than -5%. If the lower bound of the CI was greater than -5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.|Difference in proportions|-3.2|||||TWO_SIDED|95.0|-6.0|-0.4|||||Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.|||-0.4|-6.0|
71937410|NCT01533428|143395888|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.6||||0.025|TWO_SIDED|95.0|-12.3|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level||-0.8|-12.3|0.025
71937411|NCT01533428|143395889|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.1||||0.018|TWO_SIDED|95.0|-12.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.2|-12.9|0.018
71937412|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.1||||0.208|TWO_SIDED|95.0|-10.4|2.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.||2.3|-10.4|0.208
71937413|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.7||||0.036|TWO_SIDED|95.0|-13.1|-0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.||-0.4|-13.1|0.036
71937414|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.027|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.||-0.8|-13.5|0.027
71937415|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.3||||0.024|TWO_SIDED|95.0|-13.6|-1.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.||-1.0|-13.6|0.024
71937416|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.3||||0.051|TWO_SIDED|95.0|-12.6|0.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.||0.0|-12.6|0.051
71937417|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-8.1||||0.012|TWO_SIDED|95.0|-14.4|-1.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.||-1.8|-14.4|0.012
71937418|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.2||||0.026|TWO_SIDED|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.||-0.8|-13.5|0.026
71937419|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-6.9||||0.032|TWO_SIDED|95.0|-13.2|-0.6|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.||-0.6|-13.2|0.032
71937420|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.5||||0.02|TWO_SIDED|95.0|-13.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.||-1.2|-13.9|0.020
71937421|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-7.4||||0.022|TWO_SIDED|95.0|-13.7|-1.1|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.||-1.1|-13.7|0.022
71937422|NCT01533428|143395890|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.005|TWO_SIDED|95.0|-15.3|-2.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.||-2.7|-15.3|0.005
71937423|NCT01533428|143395892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.108|TWO_SIDED|95.0|0.9|2.2|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.2|0.9|0.108
71937424|NCT01533428|143395892|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.5||||0.05|TWO_SIDED|95.0|1.0|2.4|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.4|1.0|0.050
71937425|NCT01533428|143395893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.403|TWO_SIDED|95.0|0.7|2.1|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.1|0.7|0.403
71937426|NCT01533428|143395893|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.446|TWO_SIDED|95.0|0.7|2.0|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.||2.0|0.7|0.446
71937427|NCT01533428|143395894|SUPERIORITY_OR_OTHER|||||||0.072|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.072
71937428|NCT01533428|143395895|SUPERIORITY_OR_OTHER|||||||0.075|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.075
71937429|NCT01533428|143395896|SUPERIORITY_OR_OTHER|||||||0.169|TWO_SIDED||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.||||0.169
71937430|NCT01533428|143395897|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.32|TWO_SIDED|95.0|-1.6|5.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.||5.0|-1.6|0.320
71937431|NCT01533428|143395897|SUPERIORITY_OR_OTHER||LS Mean Difference|1.2||||0.473|TWO_SIDED|95.0|-2.1|4.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.||4.5|-2.1|0.473
71937432|NCT01533428|143395897|SUPERIORITY_OR_OTHER||LS Mean Difference|1.7||||0.514|TWO_SIDED|95.0|-4.4|2.2|||ANCOVA|||The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.||2.2|-4.4|0.514
71937433|NCT01533428|143395898|SUPERIORITY_OR_OTHER||LS Mean Difference|0.1||||0.719|TWO_SIDED|95.0|-0.5|0.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.7|-0.5|0.719
71937434|NCT01533428|143395898|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.3||||0.334|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.3|-0.8|0.334
71937435|NCT01533428|143395898|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.726|TWO_SIDED|95.0|-0.7|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.5|-0.7|0.726
71937436|NCT01533428|143395899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.841|TWO_SIDED|95.0|-0.6|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.||0.5|-0.6|0.841
71937437|NCT01533428|143395899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.4||||0.171|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.||0.2|-0.9|0.171
71937438|NCT01533428|143395899|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.1||||0.595|TWO_SIDED|95.0|-0.7|0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.||0.4|-0.7|0.595
71937439|NCT01533428|143395901|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.0||||0.03|TWO_SIDED|95.0|-17.2|-0.9|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-0.9|-17.2|0.030
71937440|NCT01533428|143395901|SUPERIORITY_OR_OTHER||LS Mean Difference|-9.5||||0.02|TWO_SIDED|95.0|-17.4|-1.5|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.||-1.5|-17.4|0.020
71937441|NCT01364870|143395906|SUPERIORITY|||||||0.016||||||The p value was adjusted using Bonferroni's method to account for the multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.016
71937442|NCT01364870|143395907|SUPERIORITY|||||||0.008||||||P-value was adjusted using Bonferroni's method to account for multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.||||0.008
71937443|NCT01200394|143395908|SUPERIORITY||Geometric Mean Ratio|0.843||||0.9889|TWO_SIDED|95.0|0.728|0.975||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.|ANCOVA||Geometric mean ratio and corresponding 95% credible intervals were calculated.|Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||0.975|0.728|0.9889
71937444|NCT01200394|143395908|SUPERIORITY|||||||0.2402|TWO_SIDED|||||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.|ANCOVA|||ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.||||0.2402
71937445|NCT01200394|143395909|SUPERIORITY||Geometric Mean Ratio|0.8759||||0.0382|TWO_SIDED|95.0|0.7727|0.9927|||Mixed Models Analysis|||Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9927|0.7727|0.0382
71937446|NCT01200394|143395909|SUPERIORITY||Geometric Mean Ratio|0.8311||||0.0112|TWO_SIDED|95.0|0.7208|0.9584|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9584|0.7208|0.0112
71937447|NCT01200394|143395909|SUPERIORITY||Geometric Mean Ratio|0.8816||||0.149|TWO_SIDED|95.0|0.7427|1.0465|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0465|0.7427|0.1490
71937448|NCT01200394|143395910|SUPERIORITY||Geometric Mean Ratio|0.8565||||0.0297|TWO_SIDED|95.0|0.745|0.9847|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9847|0.7450|0.0297
71937449|NCT01200394|143395910|SUPERIORITY||Geometric Mean Ratio|0.8524||||0.0305|TWO_SIDED|95.0|0.7376|0.985|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9850|0.7376|0.0305
71937450|NCT01200394|143395910|SUPERIORITY||Geometric Mean Ratio|0.7937||||0.0068|TWO_SIDED|95.0|0.6717|0.9378|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9378|0.6717|0.0068
71937451|NCT01200394|143395910|SUPERIORITY||Geometric Mean Ratio|0.8634||||0.1151|TWO_SIDED|95.0|0.719|1.0368|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0368|0.7190|0.1151
71937452|NCT01200394|143395911|SUPERIORITY||Geometric Mean Ratio|0.9816||||0.3585|TWO_SIDED|95.0|0.9434|1.0214|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0214|0.9434|0.3585
71937453|NCT01200394|143395911|SUPERIORITY||Geometric Mean Ratio|0.9939||||0.7475|TWO_SIDED|95.0|0.9577|1.0315|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0315|0.9577|0.7475
71937454|NCT01200394|143395911|SUPERIORITY||Geometric Mean Ratio|0.9866||||0.4972|TWO_SIDED|95.0|0.9488|1.0259|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0259|0.9488|0.4972
71937455|NCT01200394|143395911|SUPERIORITY||Geometric Mean Ratio|1.0024||||0.9146|TWO_SIDED|95.0|0.9588|1.0481|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.0481|0.9588|0.9146
71937456|NCT01200394|143395912|SUPERIORITY||Least Squares (LS) Mean Difference|-5.39|STANDARD_ERROR_OF_MEAN|1.2942|<|0.0001|TWO_SIDED|95.0|-7.94|-2.84|||Mixed Models Analysis|||Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.84|-7.94|<0.0001
71937457|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-3.71|STANDARD_ERROR_OF_MEAN|0.849|<|0.0001|TWO_SIDED|95.0|-5.38|-2.04|||Mixed Models Analysis|||Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.04|-5.38|<0.0001
71937458|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-4.59|STANDARD_ERROR_OF_MEAN|0.9489|<|0.0001|TWO_SIDED|95.0|-6.46|-2.72|||Mixed Models Analysis|||Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||-2.72|-6.46|<0.0001
71937459|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|1.4056||0.7093|TWO_SIDED|95.0|-3.29|2.24|||Mixed Models Analysis|||Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.24|-3.29|0.7093
71937460|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|0.9089||0.6564|TWO_SIDED|95.0|-1.39|2.2|||Mixed Models Analysis|||Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.20|-1.39|0.6564
71937461|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|1.0334||0.8763|TWO_SIDED|95.0|-2.2|1.87|||Mixed Models Analysis|||Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.87|-2.20|0.8763
71937462|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|1.4926||0.7491|TWO_SIDED|95.0|-3.42|2.46|||Mixed Models Analysis|||Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.46|-3.42|0.7491
71937463|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.9235||0.6141|TWO_SIDED|95.0|-2.29|1.35|||Mixed Models Analysis|||Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.35|-2.29|0.6141
71937464|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|1.0582||0.5281|TWO_SIDED|95.0|-2.75|1.42|||Mixed Models Analysis|||Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.42|-2.75|0.5281
71937465|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|0.8|STANDARD_ERROR_OF_MEAN|1.8764||0.6695|TWO_SIDED|95.0|-2.9|4.5|||Mixed Models Analysis|||Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||4.50|-2.90|0.6695
71937466|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|1.073||0.5607|TWO_SIDED|95.0|-2.74|1.49|||Mixed Models Analysis|||Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||1.49|-2.74|0.5607
71937467|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|-0.27|STANDARD_ERROR_OF_MEAN|1.2722||0.8297|TWO_SIDED|95.0|-2.78|2.23|||Mixed Models Analysis|||Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.23|-2.78|0.8297
71937468|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|0.51|STANDARD_ERROR_OF_MEAN|1.7065||0.7644|TWO_SIDED|95.0|-2.85|3.87|||Mixed Models Analysis|||Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||3.87|-2.85|0.7644
71937469|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|0.65|STANDARD_ERROR_OF_MEAN|0.9917||0.5123|TWO_SIDED|95.0|-1.3|2.61|||Mixed Models Analysis|||Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.61|-1.30|0.5123
71937470|NCT01200394|143395912|SUPERIORITY||LS Mean Difference|0.46|STANDARD_ERROR_OF_MEAN|1.1355||0.6838|TWO_SIDED|95.0|-1.77|2.7|||Mixed Models Analysis|||Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.||2.70|-1.77|0.6838
71937471|NCT01200394|143395914|SUPERIORITY||Geometric Mean Ratio|0.9282||||0.5422|TWO_SIDED|95.0|0.7297|1.1807|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.1807|0.7297|0.5422
71937472|NCT01200394|143395914|SUPERIORITY||Geometric Mean Ratio|0.7998||||0.049|TWO_SIDED|95.0|0.6402|0.999|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||0.9990|0.6402|0.0490
71937473|NCT01200394|143395914|SUPERIORITY||Geometric Mean Ratio|1.0435||||0.7264|TWO_SIDED|95.0|0.8211|1.3262|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.3262|0.8211|0.7264
71937474|NCT01200394|143395914|SUPERIORITY||Geometric Mean Ratio|1.1154||||0.3733|TWO_SIDED|95.0|0.8761|1.4201|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.||1.4201|0.8761|0.3733
71937475|NCT00461500|143395984|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.23|STANDARD_ERROR_OF_MEAN|17.6||0.683||95.0|-27.96|42.43|||ANCOVA||mean difference = drug SFC 100 minus FP 100|||42.43|-27.96|0.683
71937476|NCT01806597|143395997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|19.3||||0.0002|TWO_SIDED|95.0|2.4|154.6|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||154.6|2.4|0.0002
71937477|NCT01806597|143395997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|29.4|||<|0.0001|TWO_SIDED|95.0|4.1|211.9|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (\<90 kg or ≥90 kg).||211.9|4.1|<0.0001
71937478|NCT02247479|143396007|SUPERIORITY||Difference in Adjusted Means|-0.019||||0.8381|TWO_SIDED|95.0|-0.206|0.167|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.167|-0.206|0.8381
71937479|NCT02247479|143396007|SUPERIORITY||Difference in Adjusted Means|0.051||||0.5901|TWO_SIDED|95.0|-0.134|0.236|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.236|-0.134|0.5901
71937480|NCT02247479|143396008|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.935|TWO_SIDED|95.0|-5.2|4.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||4.8|-5.2|0.9350
71937481|NCT02247479|143396008|SUPERIORITY||Difference in Adjusted Means|0.1||||0.9789|TWO_SIDED|95.0|-5.0|5.2|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||5.2|-5.0|0.9789
71937482|NCT02247479|143396009|SUPERIORITY||Difference in Adjusted Means|0.28||||0.5538|TWO_SIDED|95.0|-0.66|1.22|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||1.22|-0.66|0.5538
71937483|NCT02247479|143396009|SUPERIORITY||Difference in Adjusted Means|-0.63||||0.2032|TWO_SIDED|95.0|-1.6|0.35|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.35|-1.60|0.2032
71937484|NCT02247479|143396010|SUPERIORITY||Difference in Adjusted Means|1.0||||0.2547|TWO_SIDED|95.0|-0.7|2.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||2.8|-0.7|0.2547
71937485|NCT02247479|143396010|SUPERIORITY||Difference in Adjusted Means|-0.2||||0.8423|TWO_SIDED|95.0|-1.9|1.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.||1.6|-1.9|0.8423
71937486|NCT02247479|143396011|SUPERIORITY||Odds Ratio (OR)|1.3||||0.3248|TWO_SIDED|95.0|0.8|2.2|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||2.2|0.8|0.3248
71937487|NCT02247479|143396011|SUPERIORITY||Odds Ratio (OR)|1.1||||0.7209|TWO_SIDED|95.0|0.7|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.||1.8|0.7|0.7209
71937488|NCT02247479|143396012|SUPERIORITY||Difference in Adjusted Means|0.6||||0.5695|TWO_SIDED|95.0|-1.4|2.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.6|-1.4|0.5695
71937489|NCT02247479|143396012|SUPERIORITY||Difference in Adjusted Means|0.3||||0.7865|TWO_SIDED|95.0|-1.7|2.3|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||2.3|-1.7|0.7865
71937490|NCT02247479|143396013|SUPERIORITY||Odds Ratio (OR)|1.0||||0.9448|TWO_SIDED|95.0|0.6|1.7|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.7|0.6|0.9448
71937491|NCT02247479|143396013|SUPERIORITY||Odds Ratio (OR)|1.0||||0.8764|TWO_SIDED|95.0|0.6|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.||1.8|0.6|0.8764
71937492|NCT02247479|143396014|SUPERIORITY||Difference in Adjusted Means|5.66||||0.0991|TWO_SIDED|95.0|-1.07|12.38|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||12.38|-1.07|0.0991
71937493|NCT02247479|143396014|SUPERIORITY||Difference in Adjusted Means|-0.99||||0.7713|TWO_SIDED|95.0|-7.66|5.69|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.||5.69|-7.66|0.7713
71937494|NCT02247479|143396015|SUPERIORITY||Difference in Adjusted Means|1.72||||0.6204|TWO_SIDED|95.0|-5.09|8.53|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.53|-5.09|0.6204
71937495|NCT02247479|143396015|SUPERIORITY||Difference in Adjusted Means|1.47||||0.6705|TWO_SIDED|95.0|-5.31|8.25|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.||8.25|-5.31|0.6705
71937496|NCT02247479|143396016|SUPERIORITY||Difference in Adjusted Means|-0.36||||0.7246|TWO_SIDED|95.0|-2.35|1.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.64|-2.35|0.7246
71937497|NCT02247479|143396016|SUPERIORITY||Difference in Adjusted Means|-1.56||||0.1193|TWO_SIDED|95.0|-3.53|0.4|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.40|-3.53|0.1193
71937498|NCT02247479|143396017|SUPERIORITY||Difference in Adjusted Means|-0.22||||0.8659|TWO_SIDED|95.0|-2.84|2.39|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||2.39|-2.84|0.8659
71937499|NCT02247479|143396017|SUPERIORITY||Difference in Adjusted Means|-1.94||||0.1399|TWO_SIDED|95.0|-4.51|0.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.64|-4.51|0.1399
71937500|NCT02247479|143396018|SUPERIORITY||Difference in Adjusted Means|0.99||||0.4855|TWO_SIDED|95.0|-1.79|3.76|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||3.76|-1.79|0.4855
71937501|NCT02247479|143396018|SUPERIORITY||Difference in Adjusted Means|-1.6||||0.2515|TWO_SIDED|95.0|-4.33|1.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.||1.13|-4.33|0.2515
71937502|NCT02247479|143396019|SUPERIORITY||Difference in Adjusted Means|-0.07||||0.2075|TWO_SIDED|95.0|-0.18|0.04|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.04|-0.18|0.2075
71937503|NCT02247479|143396019|SUPERIORITY||Difference in Adjusted Means|-0.08||||0.1222|TWO_SIDED|95.0|-0.19|0.02|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.||0.02|-0.19|0.1222
71937504|NCT02247479|143396020|SUPERIORITY||Difference in Adjusted Means|-0.022||||0.8612|TWO_SIDED|95.0|-0.266|0.223|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.223|-0.266|0.8612
71937505|NCT02247479|143396020|SUPERIORITY||Difference in Adjusted Means|0.077||||0.5317|TWO_SIDED|95.0|-0.165|0.319|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.319|-0.165|0.5317
71937506|NCT02247479|143396020|SUPERIORITY||Difference in Adjusted Means|-0.033||||0.824|TWO_SIDED|95.0|-0.322|0.257|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.257|-0.322|0.8240
71937507|NCT02247479|143396020|SUPERIORITY||Difference in Adjusted Means|0.006||||0.9676|TWO_SIDED|95.0|-0.283|0.294|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment-by-visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.||0.294|-0.283|0.9676
71937508|NCT01073020|143396021|SUPERIORITY||proportion|0.08||||0.6|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (LAGB Grp) who achieved the primary outcome.|||||0.60
71937509|NCT01073020|143396021|SUPERIORITY||proportion|0.42||||0.005|TWO_SIDED||||||Chi-squared||Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes \& Weight Management (RYGB Grp) who achieved the primary outcome.|||||0.005
71937510|NCT01073020|143396022|SUPERIORITY||Mean Difference (Net)|1.0||||0.33|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline HbA1c.|||||0.33
71937511|NCT01073020|143396022|SUPERIORITY||Mean Difference (Net)|1.4|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline HbA1c.|||||<0.001
71937512|NCT01073020|143396023|SUPERIORITY||Mean Difference (Net)|2.2|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline BMI.|||||<0.001
71937513|NCT01073020|143396023|SUPERIORITY||Mean Difference (Net)|4.6|||<|0.001|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline BMI.|||||<0.001
71937514|NCT01073020|143396024|SUPERIORITY||Mean Difference (Net)|1.5||||0.81|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (LAGB Grp), adjusted for baseline CHD risk.|||||0.81
71937515|NCT01073020|143396024|SUPERIORITY||Mean Difference (Net)|2.6||||0.009|TWO_SIDED|95.0|||||Mixed Models Analysis||Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \& Weight Management (RYGB Grp), adjusted for baseline CHD risk.|||||0.009
71937516|NCT01590433|143396056|SUPERIORITY||||||<|0.05|||||||t-test, 2 sided|||||||<0.05
71937517|NCT01787825|143396070|NON_INFERIORITY|This is McNemar design.|percentage concordance|77.19||||1|TWO_SIDED|95.0|68.68|83.93||The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.|McNemar||Overall concordance of clinically significant abnormal images.|There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.||83.93|68.68|1.0000
71937518|NCT01787825|143396072|SUPERIORITY_OR_OTHER||percentage concordance|71.93||||0.972|TWO_SIDED|95.0|63.07|79.36|||Bowkers|||||79.36|63.07|0.972
71937519|NCT03532009|143396114|SUPERIORITY|||||||0.426|||||||F-test|||The p-value was obtained by pooling the p-values from Chi-square tests performed on individual data sets using the F-distribution and reflects a global test of no difference in distribution of patients in the respective categories between SZC and placebo groups. The null hypothesis was that there is no difference between SZC and placebo in the distribution of percentage of patients in the 4 RAASi treatment categories. The hypothesis was tested at a significance level of 5%.||||0.426
71937520|NCT01602614|143396126|OTHER|Spearman Rank Correlation||||||0.3117|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.3117
71937521|NCT01602614|143396127|OTHER|Spearman Rank Correlation||||||0.6175||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.6175
71937522|NCT01602614|143396128|OTHER|Spearman Rank Correlation||||||0.7129||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.7129
71937523|NCT01602614|143396129|OTHER|Spearman Rank Correlation||||||0.9828|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9828
71937524|NCT01602614|143396130|OTHER|Spearman Rank Correlation||||||0.9656|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.9656
71937525|NCT01602614|143396131|OTHER|Spearman Rank Correlation||||||0.5113|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5113
71937526|NCT01602614|143396132|OTHER|Spearman Rank Correlation||||||0.217||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.2170
71937527|NCT01602614|143396133|OTHER|Spearman Rank Correlation||||||0.4299||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.4299
71937528|NCT01602614|143396134|OTHER|Spearman Rank Correlation||||||0.8629||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.8629
71937529|NCT01602614|143396135|OTHER|Spearman Rank Correlation||||||0.5717||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.||||0.5717
71937530|NCT03588390|143396137|OTHER||Slope|0.696|STANDARD_ERROR_OF_MEAN|0.0971|||TWO_SIDED|95.0|0.5006|0.8914|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8914|0.5006|
71937531|NCT03588390|143396137|OTHER||Slope|0.9244|STANDARD_ERROR_OF_MEAN|0.122|||TWO_SIDED|95.0|0.6764|1.1724|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1724|0.6764|
71937532|NCT03588390|143396138|OTHER||Slope|0.6533|STANDARD_ERROR_OF_MEAN|0.0982|||TWO_SIDED|95.0|0.4556|0.851|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||0.8510|0.4556|
71937533|NCT03588390|143396138|OTHER||Slope|0.8586|STANDARD_ERROR_OF_MEAN|0.1307|||TWO_SIDED|95.0|0.5929|1.1242|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of slope.|The basic model for the investigation of dose proportionality was a power model that described the functional relationship between the dose and PK endpoints.||1.1242|0.5929|
71937534|NCT01006707|143396140|SUPERIORITY_OR_OTHER|||||||0.042|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.042
71937535|NCT01006707|143396141|SUPERIORITY_OR_OTHER|||||||0.322|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.322
71937536|NCT01006707|143396142|SUPERIORITY_OR_OTHER|||||||0.261|||||||ANOVA|||Results were considered significant at p\<0.05.||||0.261
71937537|NCT05034731|143396143|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71937538|NCT05034731|143396144|NON_INFERIORITY|Non-inferiority analyses were based on paired t-tests looking at the differences in speech scores calculated using the investigational speech scores minus the control speech scores. The primary efficacy analyses tested the null hypothesis (inferiority) that the mean of the paired differences in AzBio sentence scores in quite (remote fitting - in-office fitting) are less than or equal to -10 percentile points.|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71937539|NCT00283686|143396146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2||||0.52|TWO_SIDED|95.0|-0.8|5.0||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Test for differences between treatment groups over time.||||5.0|-0.8|0.52
71937540|NCT00283686|143396146|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0||||0.006|TWO_SIDED|95.0|-1.6|-0.2||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Testing differences between blood pressure groups over time||||-0.2|-1.6|0.006
71937541|NCT00283686|143396147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1||||0.52|TWO_SIDED|95.0|-0.6|0.3||adjusting for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences in treatment over time (differences in slopes over time).||||0.3|-0.6|0.52
71937542|NCT00283686|143396147|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1||||0.55|TWO_SIDED|95.0|-0.3|0.6||adjusted for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences between groups over time (differences in slopes over time)||||0.6|-0.3|0.55
71937543|NCT00283686|143396148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.57|TWO_SIDED|95.0|-3.3|1.9|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||1.9|-3.3|0.57
71937544|NCT00283686|143396148|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|||<|0.0001|TWO_SIDED|95.0|-8.5|-3.4|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-3.4|-8.5|<0.0001
71937545|NCT00283686|143396149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.18|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.18
71937546|NCT00283686|143396149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.19|TWO_SIDED|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.6|-3.1|0.19
71937547|NCT00283686|143396150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.088||||0.58|TWO_SIDED|95.0|-0.4|0.22|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing the annual change over time between ACE/ARB and ACE alone|||0.22|-0.40|0.58
71937548|NCT00283686|143396150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.6||||0.0002|TWO_SIDED|95.0|-0.91|-0.29|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups|||-0.29|-0.91|0.0002
71937549|NCT00283686|143396151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.97||||0.29|TWO_SIDED|95.0|-2.55|8.5|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change in mL/min/1.73 m\^2 for ACE+ARB compared to ACE alone|||8.50|-2.55|0.29
71937550|NCT00283686|143396151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.98||||0.73|TWO_SIDED|95.0|-4.54|6.5|||Mixed Models Analysis|adjusting for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change mL/min/1.73 m\^2 between low and standard blood pressure groups|||6.50|-4.54|0.73
71937551|NCT00283686|143396152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.71||||0.0228|TWO_SIDED|95.0|0.53|0.95|||Regression, Cox|adjusting for age, sex, race, and clinical site||||0.95|0.53|0.0228
71937552|NCT00283686|143396152|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.93||||0.59|TWO_SIDED|95.0|0.7|1.22|||Regression, Cox|adjusting for age, sex, race, and clinical site||||1.22|0.70|0.59
71937553|NCT00283686|143396153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.016||||0.87|TWO_SIDED|95.0|-0.19|0.17|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.17|-0.19|0.87
71937554|NCT00283686|143396153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13||||0.14|TWO_SIDED|95.0|-0.046|0.31|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.31|-0.046|0.14
71937555|NCT00283686|143396154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25||||0.0221|TWO_SIDED|95.0|0.036|0.46|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||0.46|0.036|0.0221
71692430|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.89|3.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||3.19|0.89|
71692431|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.16|||||TWO_SIDED|95.0|0.63|2.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.14|0.63|
71692432|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|0.83|||||TWO_SIDED|95.0|0.44|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.57|0.44|
71692433|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.27|||||TWO_SIDED|95.0|0.56|2.91|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.91|0.56|
71692434|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|2.65|||||TWO_SIDED|95.0|1.21|5.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.81|1.21|
71692435|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.7|3.18|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.18|0.70|
71692436|NCT03311841|142899717|OTHER||Geometric least squares mean ratio|0.95|||||TWO_SIDED|95.0|0.43|2.08|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.08|0.43|
71692437|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.97|||||TWO_SIDED|95.0|0.63|1.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.48|0.63|
71692438|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.69|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.62|0.69|
71692439|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.62|1.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||1.41|0.62|
71692440|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.55|||||TWO_SIDED|95.0|0.36|0.83|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||0.83|0.36|
71692441|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.84|||||TWO_SIDED|95.0|0.44|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.61|0.44|
71692442|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.71|||||TWO_SIDED|95.0|0.89|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.89|
71692443|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.93|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||3.27|0.93|
71692444|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.72|||||TWO_SIDED|95.0|0.38|1.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran||1.38|0.38|
71692445|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.92|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.40|0.92|
71937556|NCT00283686|143396154|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23||||0.0339|TWO_SIDED|95.0|-0.44|-0.018|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site||||-0.018|-0.44|0.0339
71937557|NCT02970669|143396161|SUPERIORITY||Ratio of Geometric Means (SacVal/Ena)|0.9456||||0.0895|TWO_SIDED|95.0|0.8863|1.0088|||ANCOVA|model for a log-scaled response with treatment group as a class variable and the baseline value in logarithmic scale as a continuous covariate.||||1.0088|0.8863|0.0895
71937558|NCT02970669|143396162|SUPERIORITY||Mean Difference (Net)|293.6||||0.6316|TWO_SIDED|95.0|-916.5|1503.8|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||1503.8|-916.5|0.6316
71937559|NCT02970669|143396164|SUPERIORITY||Mean Difference (Net)|2.038||||0.057|TWO_SIDED|95.0|-0.062|4.138|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.138|-0.062|0.0570
71937560|NCT02970669|143396165|SUPERIORITY||Mean Difference (Net)|2.478||||0.0121|TWO_SIDED|95.0|0.553|4.403|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.||||4.403|0.553|0.0121
71937561|NCT00543439|143396198|SUPERIORITY||Ratio of arithmetic means|0.03||||0.002|ONE_SIDED|95.0||0.08|||Paired t-test|||Ratio of the arithmetic means of the ABR for OD cohort: OD therapy to OD cohort: RP therapy 25 IU/kg was calculated. One-sided 95% CI for this ratio was reported.||0.08||0.0020
71937562|NCT00543439|143396199|EQUIVALENCE|90% 2-sided CI for the mean difference in ABRs for the 2 prophylaxis regimens for ITT participants was constructed using the t distribution with n-1 degrees of freedom (n equals the number of participants) to assess the equivalence of the 2 regimens. Equivalence was demonstrated and the null hypothesis rejected if the limits of the 90% CI fell wholly within the interval of (-4, 4) bleeds per year.|Mean Difference (Final Values)|1.1|||||TWO_SIDED|90.0|0.03|2.22||||||||2.22|0.03|
71937563|NCT00249821|143396221|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANCOVA|||"Month 12: Analysis of co-variance (ANCOVA) method with covariates height and age at baseline was used to calculate presented p-value."||||0.001
71937564|NCT00249821|143396222|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.012
71692446|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.84|||||TWO_SIDED|95.0|1.14|2.98|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.98|1.14|
71692447|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.33|||||TWO_SIDED|95.0|0.84|2.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.11|0.84|
71692448|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.47|||||TWO_SIDED|95.0|0.91|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.38|0.91|
71692449|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.19|||||TWO_SIDED|95.0|0.81|1.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.75|0.81|
71937565|NCT00249821|143396222|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
71937566|NCT00249821|143396223|SUPERIORITY_OR_OTHER|||||||0.022||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.022
71937567|NCT00249821|143396223|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.002
71937568|NCT00249821|143396224|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANCOVA|||"Change at Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.029
71937569|NCT00249821|143396225|SUPERIORITY_OR_OTHER|||||||0.972||95.0|||||ANCOVA|||"Change at Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.972
71937570|NCT00249821|143396226|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.058
71937571|NCT00249821|143396226|SUPERIORITY_OR_OTHER|||||||0.026||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.026
71937572|NCT00249821|143396227|SUPERIORITY_OR_OTHER|||||||0.793||95.0|||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.793
71937573|NCT00249821|143396227|SUPERIORITY_OR_OTHER|||||||0.055||95.0|||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."||||0.055
71937574|NCT01202747|143396249|SUPERIORITY_OR_OTHER|||||||0.0005||||||p\<0.05 considered statistically significant|Regression, Linear|||||||0.0005
71937575|NCT02292238|143396260|OTHER||Mean Difference (Net)|1.8691|STANDARD_DEVIATION|5.5727||0.125|TWO_SIDED|||||Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||Power was calculated based on expected difference in change on the ADAS-Cog of 3 points between the treatment and control groups. Estimates based on using a two-sided alpha of 0.05 and a standard deviation of 4, enrolling 29 patients per group, (N = 58) suggest 80% power to detect a mean change of 3 between treatment and placebo.||||0.125
71937576|NCT02292238|143396261|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-0.00184|STANDARD_DEVIATION|0.0225||0.7529|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.7529
71937577|NCT02292238|143396262|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.0636|STANDARD_DEVIATION|4.8176||0.3687|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.3687
71937578|NCT02292238|143396263|OTHER||Mean Difference (Net)|1.8203|STANDARD_DEVIATION|13.8988||0.485|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.4850
71937579|NCT02292238|143396264|OTHER||Mean Difference (Net)|0.1907|STANDARD_DEVIATION|0.3097||0.0337|TWO_SIDED|||||The a priori threshold for statistical significance is 0.05.|t-test, 2 sided|Equal variance t-test.||||||0.0337
71937580|NCT02292238|143396265|OTHER|Univariable (unadjusted) and a priori threshold for statistical significance is 0.05.|Mean Difference (Net)|-1.6161|STANDARD_DEVIATION|5.6812||0.315|TWO_SIDED||||||t-test, 2 sided|Equal variance t-test.||||||0.315
71937581|NCT00494806|143396270|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7279|STANDARD_ERROR_OF_MEAN|0.15|<|0.05||95.0|0.3174|1.1383|||t-test, 2 sided|df = 64|Relative risk not calculated.|"No differences in time to first flatus between the rocking and non rocking groups is the null hypothesis.~Sample size calculations by setting the criterion for significance at .05, two-tailed test (an effect in either directions was accepted), and power at .80. A total sample of 54 participants was determined necessary to yield statistically significant results (27 in Group A and 27 in Group B)."||1.1383|0.3174|<0.05
71692450|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.2|||||TWO_SIDED|95.0|0.82|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.76|0.82|
71692451|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.08|||||TWO_SIDED|95.0|0.75|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.57|0.75|
71692452|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.89|||||TWO_SIDED|95.0|0.61|1.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.31|0.61|
71692453|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.48|||||TWO_SIDED|95.0|0.58|3.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||3.75|0.58|
71937582|NCT00814320|143396271|SUPERIORITY_OR_OTHER_LEGACY||Poisson|0.025|||<|0.0001|ONE_SIDED|99.0||0.046||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only||0.046||<0.0001
71937583|NCT00491504|143396337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.625|||||||ANCOVA|An analysis of covariance (ANCOVA) model was used with treatment as effect and Baseline as a covariate.||||||0.625
71937584|NCT03387033|143396348|OTHER||||||<|0.005|||||||Paired t-test|||||||<0.005
71937585|NCT03387033|143396349|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
71937586|NCT03387033|143396350|OTHER||||||<|0.05|||||||Paired t-test|||||||<0.05
71937587|NCT00601484|143396351|SUPERIORITY_OR_OTHER_LEGACY||Least squares (LS) mean difference|-1.36|STANDARD_ERROR_OF_MEAN|0.503|||TWO_SIDED|90.0|-2.203|-0.51||||||Analysis was based on analysis of covariance (ANCOVA) model with terms for treatment, age, gender, body mass index (BMI), baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.510|-2.203|
71937588|NCT00601484|143396352|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.41|||TWO_SIDED|90.0|-1.363|0.011||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.011|-1.363|
71937589|NCT00601484|143396352|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.13|STANDARD_ERROR_OF_MEAN|0.498|||TWO_SIDED|90.0|-1.969|-0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.297|-1.969|
71937590|NCT00601484|143396352|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.85|STANDARD_ERROR_OF_MEAN|0.559|||TWO_SIDED|90.0|-1.79|0.09||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.090|-1.790|
71937591|NCT00601484|143396352|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.45|STANDARD_ERROR_OF_MEAN|0.538|||TWO_SIDED|90.0|-1.356|0.457||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.457|-1.356|
71937592|NCT00601484|143396353|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.68|STANDARD_ERROR_OF_MEAN|6.727|||TWO_SIDED|90.0|-19.954|2.601||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.601|-19.954|
71937593|NCT00601484|143396353|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-17.74|STANDARD_ERROR_OF_MEAN|8.47|||TWO_SIDED|90.0|-31.948|-3.523||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.523|-31.948|
71937594|NCT00601484|143396353|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-20.66|STANDARD_ERROR_OF_MEAN|8.138|||TWO_SIDED|90.0|-34.347|-6.971||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.971|-34.347|
71937595|NCT00601484|143396353|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-13.58|STANDARD_ERROR_OF_MEAN|9.532|||TWO_SIDED|90.0|-29.612|2.452||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.452|-29.612|
71937596|NCT00601484|143396353|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.75|STANDARD_ERROR_OF_MEAN|8.807|||TWO_SIDED|90.0|-22.58|7.08||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.080|-22.580|
71937597|NCT00601484|143396354|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.56|STANDARD_ERROR_OF_MEAN|0.721|||TWO_SIDED|90.0|-1.768|0.65||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.650|-1.768|
71937598|NCT00601484|143396354|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.21|STANDARD_ERROR_OF_MEAN|0.898|||TWO_SIDED|90.0|-2.723|0.297||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.297|-2.723|
71937599|NCT00601484|143396354|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.47|STANDARD_ERROR_OF_MEAN|1.311|||TWO_SIDED|90.0|-3.682|0.752||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.752|-3.682|
71937600|NCT00601484|143396354|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.54|STANDARD_ERROR_OF_MEAN|0.98|||TWO_SIDED|90.0|-1.11|2.198||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.198|-1.110|
71937601|NCT00601484|143396354|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.114|||TWO_SIDED|90.0|-2.904|0.922||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.922|-2.904|
71937602|NCT00601484|143396355|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.41|STANDARD_ERROR_OF_MEAN|5.51|||TWO_SIDED|90.0|-13.65|4.826||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.826|-13.650|
71937603|NCT00601484|143396355|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.65|STANDARD_ERROR_OF_MEAN|7.041|||TWO_SIDED|90.0|-20.493|3.192||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.192|-20.493|
71937604|NCT00601484|143396355|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.72|STANDARD_ERROR_OF_MEAN|10.089|||TWO_SIDED|90.0|-26.775|7.343||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.343|-26.775|
71937605|NCT00601484|143396355|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.76|STANDARD_ERROR_OF_MEAN|7.532|||TWO_SIDED|90.0|-8.95|16.465||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.465|-8.950|
71692454|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|2.54|||||TWO_SIDED|95.0|1.11|5.85|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||5.85|1.11|
71937606|NCT00601484|143396355|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.72|STANDARD_ERROR_OF_MEAN|7.906|||TWO_SIDED|90.0|-22.299|4.851||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.851|-22.299|
71692455|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|2.16|||||TWO_SIDED|95.0|0.97|4.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||4.81|0.97|
71937607|NCT00601484|143396356|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.24|STANDARD_ERROR_OF_MEAN|0.609|||TWO_SIDED|90.0|-0.776|1.265||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.265|-0.776|
71937608|NCT00601484|143396356|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|-0.09|STANDARD_ERROR_OF_MEAN|0.674|||TWO_SIDED|90.0|-1.22|1.044||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.044|-1.220|
71937609|NCT00601484|143396356|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.57|STANDARD_ERROR_OF_MEAN|1.009|||TWO_SIDED|90.0|-1.124|2.269||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.269|-1.124|
71937610|NCT00601484|143396356|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.27|STANDARD_ERROR_OF_MEAN|1.019|||TWO_SIDED|90.0|-1.441|1.988||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.988|-1.441|
71937611|NCT00601484|143396356|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.99|STANDARD_ERROR_OF_MEAN|0.769|||TWO_SIDED|90.0|-0.307|2.283||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.283|-0.307|
71937612|NCT00601484|143396357|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.68|||||TWO_SIDED|90.0|-9.05|5.76||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.76|-9.05|
71937613|NCT00601484|143396357|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-2.78|||||TWO_SIDED|90.0|-12.65|4.24||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.24|-12.65|
71937614|NCT00601484|143396357|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|0.04|||||TWO_SIDED|90.0|-8.96|7.9||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||7.90|-8.96|
71937615|NCT00601484|143396357|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.38|||||TWO_SIDED|90.0|-11.57|8.28||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||8.28|-11.57|
71937616|NCT00601484|143396357|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|3.97|||||TWO_SIDED|90.0|-6.82|13.02||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||13.02|-6.82|
71937617|NCT00601484|143396358|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.72|STANDARD_ERROR_OF_MEAN|1.01|||TWO_SIDED|90.0|-2.414|0.983||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.983|-2.414|
71937618|NCT00601484|143396358|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.42|STANDARD_ERROR_OF_MEAN|1.169|||TWO_SIDED|90.0|-1.548|2.384||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.384|-1.548|
71937619|NCT00601484|143396358|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.31|STANDARD_ERROR_OF_MEAN|0.821|||TWO_SIDED|90.0|-0.075|2.693||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||2.693|-0.075|
71937620|NCT00601484|143396358|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|1.093|||TWO_SIDED|90.0|-2.178|1.512||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.512|-2.178|
71937621|NCT00601484|143396358|SUPERIORITY_OR_OTHER_LEGACY||LS Mean difference|2.07|STANDARD_ERROR_OF_MEAN|1.208|||TWO_SIDED|90.0|0.038|4.112||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.112|0.038|
71937622|NCT00601484|143396359|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-6.41|||||TWO_SIDED|90.0|-33.33|18.68||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||18.68|-33.33|
71937623|NCT00601484|143396359|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|15.83|||||TWO_SIDED|90.0|-14.12|41.18||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||41.18|-14.12|
71937624|NCT00601484|143396359|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|19.17|||||TWO_SIDED|90.0|0.0|38.1||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||38.10|0.00|
71937625|NCT00601484|143396359|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-0.71|||||TWO_SIDED|90.0|-30.95|32.73||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||32.73|-30.95|
71937626|NCT00601484|143396359|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|34.89|||||TWO_SIDED|90.0|-4.57|70.0||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||70.00|-4.57|
71937627|NCT00601484|143396360|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.34|||TWO_SIDED|90.0|-0.529|0.61||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.610|-0.529|
71937628|NCT00601484|143396360|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.52|STANDARD_ERROR_OF_MEAN|0.334|||TWO_SIDED|90.0|-1.077|0.043||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.043|-1.077|
71937629|NCT00601484|143396360|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.366|||TWO_SIDED|90.0|-0.835|0.396||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.396|-0.835|
71937630|NCT00601484|143396360|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.22|STANDARD_ERROR_OF_MEAN|0.294|||TWO_SIDED|90.0|-0.718|0.273||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.273|-0.718|
71692456|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|2.94|||||TWO_SIDED|95.0|1.28|6.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin||6.77|1.28|
71937631|NCT00601484|143396360|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.442|||TWO_SIDED|90.0|-1.044|0.445||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.445|-1.044|
71937632|NCT00601484|143396361|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-1.24|||||TWO_SIDED|90.0|-27.56|5.37||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||5.37|-27.56|
71937633|NCT00601484|143396361|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-22.43|||||TWO_SIDED|90.0|-56.39|0.0||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-56.39|
71937634|NCT00601484|143396361|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-16.0|||||TWO_SIDED|90.0|-40.44|0.0||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-40.44|
71937635|NCT00601484|143396361|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-14.18|||||TWO_SIDED|90.0|-50.71|0.0||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||0.00|-50.71|
71937636|NCT00601484|143396361|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-8.61|||||TWO_SIDED|90.0|-36.87|4.64||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\]) as stratification variable.||4.64|-36.87|
71937637|NCT00601484|143396362|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.1|STANDARD_ERROR_OF_MEAN|12.495|||TWO_SIDED|90.0|-15.852|26.044||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||26.044|-15.852|
71937638|NCT00601484|143396362|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.27|STANDARD_ERROR_OF_MEAN|12.802|||TWO_SIDED|90.0|-17.216|25.764||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||25.764|-17.216|
71937639|NCT00601484|143396362|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|13.741|||TWO_SIDED|90.0|-25.917|20.307||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.307|-25.917|
71937640|NCT00601484|143396362|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.73|STANDARD_ERROR_OF_MEAN|12.416|||TWO_SIDED|90.0|-21.626|20.162||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||20.162|-21.626|
71692457|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.11|||||TWO_SIDED|95.0|0.59|2.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.07|0.59|
71937641|NCT00601484|143396362|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|10.51|STANDARD_ERROR_OF_MEAN|14.469|||TWO_SIDED|90.0|-13.858|34.868||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||34.868|-13.858|
71937642|NCT00601484|143396363|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.63|STANDARD_ERROR_OF_MEAN|6.968|||TWO_SIDED|90.0|-8.049|15.316||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.316|-8.049|
71937643|NCT00601484|143396363|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|3.19|STANDARD_ERROR_OF_MEAN|7.353|||TWO_SIDED|90.0|-9.153|15.533||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||15.533|-9.153|
71937644|NCT00601484|143396363|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|7.651|||TWO_SIDED|90.0|-13.806|11.932||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.932|-13.806|
71937645|NCT00601484|143396363|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|6.79|STANDARD_ERROR_OF_MEAN|7.543|||TWO_SIDED|90.0|-5.901|19.486||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||19.486|-5.901|
71937646|NCT00601484|143396363|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.77|STANDARD_ERROR_OF_MEAN|8.31|||TWO_SIDED|90.0|-9.221|18.765||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||18.765|-9.221|
71937647|NCT00601484|143396364|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.86|STANDARD_ERROR_OF_MEAN|0.407|||TWO_SIDED|90.0|-1.546|-0.182||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.182|-1.546|
71937648|NCT00601484|143396364|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.484|||TWO_SIDED|90.0|-2.196|-0.57||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.570|-2.196|
71937649|NCT00601484|143396364|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.54|||TWO_SIDED|90.0|-2.204|-0.388||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.388|-2.204|
71937650|NCT00601484|143396364|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|0.553|||TWO_SIDED|90.0|-2.032|-0.172||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.172|-2.032|
71937651|NCT00601484|143396364|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.02|STANDARD_ERROR_OF_MEAN|0.512|||TWO_SIDED|90.0|-1.878|-0.152||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.152|-1.878|
71937652|NCT00601484|143396365|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.24|STANDARD_ERROR_OF_MEAN|8.064|||TWO_SIDED|90.0|-29.757|-2.718||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-2.718|-29.757|
71937653|NCT00601484|143396365|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-27.96|STANDARD_ERROR_OF_MEAN|10.059|||TWO_SIDED|90.0|-44.846|-11.075||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-11.075|-44.846|
71937654|NCT00601484|143396365|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-25.72|STANDARD_ERROR_OF_MEAN|11.508|||TWO_SIDED|90.0|-45.079|-6.369||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-6.369|-45.079|
71937655|NCT00601484|143396365|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.56|STANDARD_ERROR_OF_MEAN|12.157|||TWO_SIDED|90.0|-40.017|0.902||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.902|-40.017|
71937656|NCT00601484|143396365|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.9|STANDARD_ERROR_OF_MEAN|11.124|||TWO_SIDED|90.0|-40.633|-3.171||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-3.171|-40.633|
71937657|NCT00601484|143396366|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.5|STANDARD_ERROR_OF_MEAN|0.86|||TWO_SIDED|90.0|-2.942|-0.057||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.057|-2.942|
71937658|NCT00601484|143396366|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.08|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|90.0|-3.458|-0.705||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.705|-3.458|
71937659|NCT00601484|143396366|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.13|STANDARD_ERROR_OF_MEAN|1.267|||TWO_SIDED|90.0|-4.265|-0.004||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.004|-4.265|
71692458|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.24|||||TWO_SIDED|95.0|0.71|2.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.17|0.71|
71692459|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|0.94|||||TWO_SIDED|95.0|0.55|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.62|0.55|
71692460|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.12|||||TWO_SIDED|95.0|0.64|1.96|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.96|0.64|
71692461|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.1|||||TWO_SIDED|95.0|0.46|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.64|0.46|
71692462|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.87|||||TWO_SIDED|95.0|0.81|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||4.32|0.81|
71692463|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.13|||||TWO_SIDED|95.0|0.51|2.53|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.53|0.51|
71692464|NCT03311841|142899718|OTHER||Geometric least squares mean ratio|1.04|||||TWO_SIDED|95.0|0.45|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||2.41|0.45|
71692465|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.68|||||TWO_SIDED|95.0|0.78|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam||3.62|0.78|
71937660|NCT00601484|143396366|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|1.531|||TWO_SIDED|90.0|-4.029|1.124||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.124|-4.029|
71692466|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.3|||||TWO_SIDED|95.0|0.75|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||2.23|0.75|
71692467|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.98|||||TWO_SIDED|95.0|1.15|3.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||3.41|1.15|
71937661|NCT00601484|143396366|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.24|STANDARD_ERROR_OF_MEAN|1.293|||TWO_SIDED|90.0|-4.419|-0.063||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.063|-4.419|
71692468|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|0.98|||||TWO_SIDED|95.0|0.58|1.66|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin||1.66|0.58|
71692469|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.03|||||TWO_SIDED|95.0|0.52|2.03|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.03|0.52|
71692470|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.51|||||TWO_SIDED|95.0|0.77|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.97|0.77|
71692471|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.07|||||TWO_SIDED|95.0|0.56|2.05|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||2.05|0.56|
71692472|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|0.6|||||TWO_SIDED|95.0|0.3|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone||1.17|0.30|
71692473|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.57|||||TWO_SIDED|95.0|0.84|2.94|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.94|0.84|
71692474|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.49|||||TWO_SIDED|95.0|0.81|2.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin||2.73|0.81|
71937662|NCT00601484|143396367|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.93|||||TWO_SIDED|90.0|-27.32|11.32||||||Week 2: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||11.32|-27.32|
71937663|NCT00601484|143396367|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-17.9|||||TWO_SIDED|90.0|-42.04|4.37||||||Week 4: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||4.37|-42.04|
71937664|NCT00601484|143396367|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-24.44|||||TWO_SIDED|90.0|-51.58|0.67||||||Week 6: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||0.67|-51.58|
71937665|NCT00601484|143396367|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-7.5|||||TWO_SIDED|90.0|-41.71|17.33||||||Week 10: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||17.33|-41.71|
71937666|NCT00601484|143396367|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehman median difference|-21.37|||||TWO_SIDED|90.0|-54.76|7.92||||||Week 16: Van elteren test was used to compare the percent change from baseline between tanezumab and placebo using baseline average daily pain score (moderate \[4 to less than 7\] or severe \[greater than or equal to 7\] as stratification variable.||7.92|-54.76|
71937667|NCT00601484|143396368|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.32|STANDARD_ERROR_OF_MEAN|0.165|||TWO_SIDED|90.0|-0.591|-0.04||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.040|-0.591|
71937668|NCT00601484|143396368|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.36|STANDARD_ERROR_OF_MEAN|0.225|||TWO_SIDED|90.0|-0.734|0.02||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.020|-0.734|
71937669|NCT00601484|143396368|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.37|STANDARD_ERROR_OF_MEAN|0.211|||TWO_SIDED|90.0|-0.724|-0.015||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.015|-0.724|
71937670|NCT00601484|143396368|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.41|STANDARD_ERROR_OF_MEAN|0.238|||TWO_SIDED|90.0|-0.806|-0.005||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.005|-0.806|
71937671|NCT00601484|143396368|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.12|STANDARD_ERROR_OF_MEAN|0.206|||TWO_SIDED|90.0|-0.47|0.223||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.223|-0.470|
71937672|NCT00601484|143396369|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-15.34|STANDARD_ERROR_OF_MEAN|8.425|||TWO_SIDED|90.0|-29.468|-1.209||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-1.209|-29.468|
71937673|NCT00601484|143396369|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-16.97|STANDARD_ERROR_OF_MEAN|11.102|||TWO_SIDED|90.0|-35.608|1.665||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.665|-35.608|
71937674|NCT00601484|143396369|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-18.04|STANDARD_ERROR_OF_MEAN|10.358|||TWO_SIDED|90.0|-35.476|-0.613||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||-0.613|-35.476|
71937675|NCT00601484|143396369|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-19.48|STANDARD_ERROR_OF_MEAN|13.631|||TWO_SIDED|90.0|-42.418|3.46||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||3.460|-42.418|
71937676|NCT00601484|143396369|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-9.16|STANDARD_ERROR_OF_MEAN|10.097|||TWO_SIDED|90.0|-26.174|7.849||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||7.849|-26.174|
71937677|NCT00601484|143396370|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.68|STANDARD_ERROR_OF_MEAN|0.404|||TWO_SIDED|90.0|-1.394|0.03||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.030|-1.394|
71937678|NCT00601484|143396370|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.34|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|90.0|-1.149|0.468||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.468|-1.149|
71937679|NCT00601484|143396370|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.449|||TWO_SIDED|90.0|-1.443|0.156||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.156|-1.443|
71937680|NCT00601484|143396370|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.06|STANDARD_ERROR_OF_MEAN|0.546|||TWO_SIDED|90.0|-1.046|0.931||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.931|-1.046|
71937681|NCT00601484|143396370|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.673|||TWO_SIDED|90.0|-1.876|0.592||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.592|-1.876|
71937682|NCT00601484|143396371|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-34.25|STANDARD_ERROR_OF_MEAN|21.509|||TWO_SIDED|90.0|-72.879|4.375||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||4.375|-72.879|
71937683|NCT00601484|143396371|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-30.97|STANDARD_ERROR_OF_MEAN|24.418|||TWO_SIDED|90.0|-75.23|13.285||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||13.285|-75.230|
71937684|NCT00601484|143396371|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-37.18|STANDARD_ERROR_OF_MEAN|28.74|||TWO_SIDED|90.0|-90.62|16.265||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||16.265|-90.620|
71937685|NCT00601484|143396371|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|5.77|STANDARD_ERROR_OF_MEAN|43.222|||TWO_SIDED|90.0|-74.604|86.142||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||86.142|-74.604|
71937686|NCT00601484|143396371|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-21.35|STANDARD_ERROR_OF_MEAN|70.862|||TWO_SIDED|90.0|-164.142|121.438||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||121.438|-164.142|
71937687|NCT00601484|143396374|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.788|||TWO_SIDED|90.0|-2.562|0.081||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.081|-2.562|
71937688|NCT00601484|143396374|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.12|STANDARD_ERROR_OF_MEAN|0.986|||TWO_SIDED|90.0|-2.782|0.535||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.535|-2.782|
71937689|NCT00601484|143396374|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.11|STANDARD_ERROR_OF_MEAN|1.14|||TWO_SIDED|90.0|-3.036|0.819||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.819|-3.036|
71937690|NCT00601484|143396374|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.816|||TWO_SIDED|90.0|-1.534|1.221||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.221|-1.534|
71937691|NCT00601484|143396374|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.54|STANDARD_ERROR_OF_MEAN|1.083|||TWO_SIDED|90.0|-2.398|1.32||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||1.320|-2.398|
71937692|NCT00601484|143396375|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-10.99|STANDARD_ERROR_OF_MEAN|6.718|||TWO_SIDED|90.0|-22.25|0.277||||||Week 2: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||0.277|-22.250|
71937693|NCT00601484|143396375|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.43|STANDARD_ERROR_OF_MEAN|8.66|||TWO_SIDED|90.0|-23.001|6.132||||||Week 4: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||6.132|-23.001|
71937694|NCT00601484|143396375|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-8.14|STANDARD_ERROR_OF_MEAN|9.737|||TWO_SIDED|90.0|-24.602|8.327||||||Week 6: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.327|-24.602|
71937695|NCT00601484|143396375|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.45|STANDARD_ERROR_OF_MEAN|7.406|||TWO_SIDED|90.0|-13.948|11.04||||||Week 10: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||11.040|-13.948|
71937696|NCT00601484|143396375|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-7.83|STANDARD_ERROR_OF_MEAN|9.352|||TWO_SIDED|90.0|-23.884|8.234||||||Week 16: Analysis was based on ANCOVA model with terms for treatment, age, gender, BMI, baseline severity of pain and concomitant medications (amitriptyline, pentosan polysulfate sodium, hydroxyzine) use.||8.234|-23.884|
71937697|NCT00601484|143396376|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|5.064|||||TWO_SIDED|90.0|1.709|15.007||||||Week 6: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||15.007|1.709|
71937698|NCT00601484|143396376|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.722|||||TWO_SIDED|90.0|0.756|9.795||||||Week 16: Analysis was based on proportional odds analysis, to determine the odds ratio for the odds of responding (compared to not responding) on Tanezumab vs placebo.||9.795|0.756|
71937699|NCT01463683|143396399|NON_INFERIORITY_OR_EQUIVALENCE|Incidence of seroprotection with V232-2XP SC is non-inferior to V232-1XP SC if the lower bound of the 95% confidence interval of the difference is greater than -10%|Difference in percentage of participants|7.6|||||TWO_SIDED|95.0|1.9|13.6|||Miettinen & Nurminen|||||13.6|1.9|
71937700|NCT01463683|143396400|SUPERIORITY_OR_OTHER||Difference in percentage of participants|4.9||||0.162|TWO_SIDED|95.0|-2.0|11.9|||Miettinen & Nurminen|||||11.9|-2.0|0.162
71937701|NCT01463683|143396400|SUPERIORITY_OR_OTHER||Difference in percentage of participants|11.0||||0.028|TWO_SIDED|95.0|1.1|21.6|||Miettinen & Nurminen|||||21.6|1.1|0.028
71937702|NCT01463683|143396400|SUPERIORITY_OR_OTHER||Difference in percentage of participants|6.0||||0.246|TWO_SIDED|95.0|-4.0|16.8|||Miettinen & Nurminen|||||16.8|-4.0|0.246
71937703|NCT01463683|143396401|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.7||||0.659|TWO_SIDED|95.0|-3.8|2.4|||Miettinen & Nurminen|||||2.4|-3.8|0.659
71692475|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.44|||||TWO_SIDED|95.0|0.84|2.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||2.47|0.84|
71692476|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.06|||||TWO_SIDED|95.0|0.63|1.78|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin||1.78|0.63|
71692477|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.85|||||TWO_SIDED|95.0|0.95|3.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.61|0.95|
71692478|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|3.1|||||TWO_SIDED|95.0|1.64|5.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||5.86|1.64|
71692479|NCT03311841|142899719|OTHER||Geometric least squares mean ratio|1.75|||||TWO_SIDED|95.0|0.95|3.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin||3.24|0.95|
71692480|NCT03138577|142899732|OTHER||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
71692481|NCT03138577|142899733|OTHER|||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.|||
71937704|NCT01463683|143396401|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-1.6||||0.459|TWO_SIDED|95.0|-7.7|2.2|||Miettinen & Nurminen|||||2.2|-7.7|0.459
71937705|NCT01463683|143396401|SUPERIORITY_OR_OTHER||Difference in percentage of participants|-0.9||||0.686|TWO_SIDED|95.0|-7.1|3.0|||Miettinen & Nurminen|||||3.0|-7.1|0.686
71937706|NCT04345471|143396408|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-0.6||||0.509|TWO_SIDED|95.0|-2.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-2.5|0.509
71937707|NCT04345471|143396408|SUPERIORITY|To adjust for the multiplicity, only when the superiority of MD-120 50 mg to Placebo was verified, the superiority of MD-120 100 mg to Placebo was tested.|LS mean difference|-1.4||||0.131|TWO_SIDED|95.0|-3.3|0.4||A priori threshold for statistical significance is p\<0.05, 2-sided. The value was based on the post-hoc analysis by not taking into account the multiplicity.|MMRM|||||0.4|-3.3|0.131
71937708|NCT04345471|143396410|SUPERIORITY||LS mean difference|-0.2||||0.811|TWO_SIDED|95.0|-1.5|1.2||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||1.2|-1.5|0.811
71937709|NCT04345471|143396410|SUPERIORITY||LS mean difference|-0.5||||0.424|TWO_SIDED|95.0|-1.9|0.8||A priori threshold for statistical significance is p\<0.05, 2-sided.|MMRM|||||0.8|-1.9|0.424
71937710|NCT00717977|143396437|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.009
71937711|NCT00717977|143396438|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||0.04
71692482|NCT03138577|142899734|OTHER||Median Difference (Final Values)|7.5||||0.01|TWO_SIDED||||||Sign test|||||||0.01
71692483|NCT03138577|142899734|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
71692484|NCT03138577|142899735|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
71692485|NCT03138577|142899736|OTHER||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.|||
71692486|NCT03138577|142899737|OTHER||Median Difference (Final Values)|-1.0||||0.01|TWO_SIDED||||||Sign test|||||||0.01
71692487|NCT03138577|142899737|OTHER||Median Difference (Final Values)|0.0||||1|TWO_SIDED||||||Sign test|||||||1.00
71692488|NCT03138577|142899738|OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71692489|NCT01852513|142899759|SUPERIORITY|||||||0.391|||||||t-test, 2 sided|||||||0.391
71692490|NCT01852513|142899760|SUPERIORITY|||||||0.789|||||||t-test, 2 sided|||||||0.789
71692491|NCT01852513|142899761|SUPERIORITY|||||||0.778|||||||t-test, 2 sided|||||||0.778
71692492|NCT02686164|142899767|OTHER||Geometric Mean Ratio|0.914|||||TWO_SIDED|90.0|0.85|0.983||||||AUC(0-24) of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam Versus (vs.) Cycle 1 Day -3, Midazolam||0.983|0.850|
71692493|NCT02686164|142899767|OTHER||Geometric Mean Ratio|1.148|||||TWO_SIDED|90.0|0.938|1.404||||||AUC(0-24) of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.404|0.938|
71692494|NCT02686164|142899767|OTHER||Geometric Mean Ratio|1.12|||||TWO_SIDED|90.0|0.94|1.335||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.335|0.940|
71692495|NCT02686164|142899767|OTHER||Geometric Mean Ratio|1.199|||||TWO_SIDED|90.0|1.057|1.36||||||AUC(0-24) of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady-state) + Midazolam vs.Cycle 1 Day -3, Midazolam||1.360|1.057|
71692496|NCT02686164|142899768|OTHER||Geometric Mean Ratio|0.862|||||TWO_SIDED|90.0|0.753|0.988||||||Cmax of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||0.988|0.753|
71937712|NCT00717977|143396439|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Adjusted for device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.||||<0.001
71937713|NCT01513551|143396479|OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|95.0|-1.4|15.0|||Miettinen & Nurminen|||||15.0|-1.4|
71937714|NCT01513551|143396479|OTHER||Risk Difference (RD)|9.5|||||TWO_SIDED|95.0|1.1|17.7|||Miettinen & Nurminen|||||17.7|1.1|
71937715|NCT00094302|143396488|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.14|TWO_SIDED|95.0|0.77|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.77|0.14
71937716|NCT00094302|143396489|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9||||0.35|TWO_SIDED|95.0|0.73|1.12||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event."||1.12|0.73|0.35
71937717|NCT00094302|143396490|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.48|TWO_SIDED|95.0|0.14|2.5||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event."||2.50|0.14|0.48
71937718|NCT00094302|143396491|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.83||||0.04|TWO_SIDED|95.0|0.69|0.99||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event"||0.99|0.69|0.04
71937719|NCT00094302|143396492|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.91||||0.29|TWO_SIDED|95.0|0.77|1.08||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject's last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.||1.08|0.77|0.29
71937720|NCT00094302|143396493|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.28|TWO_SIDED|95.0|0.8|1.06||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.06|0.80|0.28
71937721|NCT00094302|143396494|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.15|TWO_SIDED|95.0|0.76|1.04||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.04|0.76|0.15
71937722|NCT00094302|143396495|SUPERIORITY_OR_OTHER||incidence rate ratio|0.75||||0.03|TWO_SIDED|95.0|0.58|0.97||No covariate adjustment|Negative binomial regression||Spironolactone compared to Placebo|There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.||0.97|0.58|0.03
71937723|NCT00094302|143396496|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.96||||0.82|TWO_SIDED|95.0|0.67|1.38||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.38|0.67|0.82
71692497|NCT02686164|142899768|OTHER||Geometric Mean Ratio|1.027|||||TWO_SIDED|90.0|0.852|1.238||||||Cmax of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.238|0.852|
71937724|NCT00094302|143396497|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.08||||0.76|TWO_SIDED|95.0|0.64|1.83||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events."||1.83|0.64|0.76
71937725|NCT00094302|143396498|SUPERIORITY_OR_OTHER||Hazard Ratio, log|1.02||||0.94|TWO_SIDED|95.0|0.69|1.5||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events."||1.50|0.69|0.94
71937726|NCT00094302|143396499|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0||||0.98|TWO_SIDED|95.0|0.71|1.42||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events."||1.42|0.71|0.98
71937727|NCT00094302|143396500|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.73|TWO_SIDED|95.0|0.65|1.35||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events."||1.35|0.65|0.73
71937728|NCT00094302|143396501|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.49|||<|0.01|TWO_SIDED|95.0|1.18|1.87||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee."||1.87|1.18|<0.01
71692498|NCT02686164|142899768|OTHER||Geometric Mean Ratio|1.055|||||TWO_SIDED|90.0|0.879|1.268||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.268|0.879|
71692499|NCT02686164|142899768|OTHER||Geometric Mean Ratio|0.94|||||TWO_SIDED|90.0|0.845|1.046||||||Cmax of 1'-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam||1.046|0.845|
71692500|NCT00672633|142899783|SUPERIORITY_OR_OTHER||Mean Difference (Net)|20.0||||0.52||95.0|||||ANOVA|Repeated measures||The study was designed with 80% power to detect a net improvement of Triglyceride elevles with a sample size of 60.||||0.52
71692501|NCT00672633|142899784|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.06||95.0|||||ANOVA|Repeated Measures||No power calculations done for this outcomes||||0.06
71937729|NCT00094302|143396502|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.75|TWO_SIDED|95.0|0.66|1.35||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.||1.35|0.66|0.75
71937730|NCT00094302|143396503|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
71937731|NCT00094302|143396503|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71937732|NCT00094302|143396504|SUPERIORITY_OR_OTHER|||||||0.87|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.87
71692502|NCT00672633|142899785|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.3||||0.27||95.0|||||ANOVA|Repeated Measures||No power calculations were conducted for this outcome||||0.27
71692503|NCT02465164|142899789|OTHER|Wilcoxon rank-sum tests||||||0.208|||||||Wilcoxon (Mann-Whitney)|||||||0.208
71692504|NCT01689441|142899790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.25|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.25
71692505|NCT01689441|142899791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.51|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.51
71937733|NCT00094302|143396504|SUPERIORITY_OR_OTHER|||||||0.16|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.16
71937734|NCT00094302|143396505|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.||||0.99
71937735|NCT00094302|143396506|SUPERIORITY_OR_OTHER|||||||0.39|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.39
71937736|NCT00094302|143396506|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.01
71937737|NCT00094302|143396507|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.25|TWO_SIDED|95.0|0.85|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee."||1.04|0.85|0.25
71937738|NCT00094302|143396508|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.27
71937739|NCT00094302|143396508|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71937740|NCT00094302|143396509|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.53
71692506|NCT01689441|142899792|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.54
71692507|NCT01481558|142899795|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_DEVIATION|0.01||0.55|TWO_SIDED|95.0|||||ANCOVA|||||||0.55
71692508|NCT04235504|142899840|SUPERIORITY||Mean Difference (Final Values)|-1.42|||<|0.0001|TWO_SIDED|95.0|-1.74|-1.1|||linear mixed model|||||-1.10|-1.74|<0.0001
71692509|NCT04235504|142899841|SUPERIORITY||Mean Difference (Final Values)|27.59|||<|0.0001|TWO_SIDED|95.0|21.59|33.6|||linear mixed model|||||33.60|21.59|<0.0001
71692510|NCT04235504|142899842|SUPERIORITY||Mean Difference (Final Values)|-27.86|||<|0.0001|TWO_SIDED|95.0|-34.16|-21.55|||linear mixed model|||||-21.55|-34.16|<0.0001
71692511|NCT04235504|142899843|SUPERIORITY||Mean Difference (Final Values)|0.12||||0.6227|TWO_SIDED|95.0|-0.37|0.61|||linear mixed model|||||0.61|-0.37|0.6227
71937741|NCT00094302|143396509|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71937742|NCT00094302|143396510|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.11
71937743|NCT00094302|143396510|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||<0.01
71937744|NCT00094302|143396511|SUPERIORITY_OR_OTHER|||||||0.59|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.59
71937745|NCT00094302|143396511|SUPERIORITY_OR_OTHER|||||||0.54|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.54
71937746|NCT00094302|143396512|SUPERIORITY_OR_OTHER|||||||0.98|TWO_SIDED||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.98
71937747|NCT00094302|143396512|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.||||0.02
71937748|NCT02780661|143396517|OTHER||Least square (LS) mean difference|-0.86||||0.0144|TWO_SIDED|95.0|-1.53|-0.196||Log10 change from baseline in aerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||-0.196|-1.530|0.0144
71937749|NCT02780661|143396518|OTHER||LS mean difference|-0.48||||0.1879|TWO_SIDED|95.0|-1.23|0.261||Log10 change from baseline in anaerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.||0.261|-1.230|0.1879
71937750|NCT00494975|143396523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.94|STANDARD_ERROR_OF_MEAN|0.32|<|0.05|TWO_SIDED|95.0|0.31|1.56|||generalized estimating equations (GEE)|||The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.||1.56|0.31|<0.05
71937751|NCT01806688|143396525|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
71937752|NCT01806688|143396526|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
71937753|NCT01806688|143396528|EQUIVALENCE|The study is designed to detect a 10.0% difference in area under the curve (AUC) appetite ratings between foods. The required number of Participants is 38.|||||<|0.05|||||||ANCOVA|Sources of variation included in the model: snack, visit number, baseline score, visit number × snack, and snack × overweight.||Items #1 were compared to each other and Items #2 were compared to each other||||<0.05
71937754|NCT00006170|143396534|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.001|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.001
71937755|NCT00006170|143396534|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.25||95.0|||||Regression, Logistic|||||||0.25
71937756|NCT00006170|143396534|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.07||95.0|||||Regression, Logistic|||||||0.07
71937757|NCT00006170|143396535|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.|||||<|0.001||95.0|||||Regression, Logistic|||||||<0.001
71937758|NCT00006170|143396535|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.053||95.0|||||Regression, Logistic|||||||0.053
71937759|NCT00006170|143396535|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.08||95.0|||||Regression, Logistic|||||||0.08
71937760|NCT00006170|143396536|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.006||95.0|||||Regression, Logistic|||||||0.006
71937761|NCT00006170|143396536|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.45||95.0|||||Regression, Logistic|||||||0.45
71937762|NCT00006170|143396536|NON_INFERIORITY_OR_EQUIVALENCE|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.046||95.0|||||Regression, Logistic|||||||0.046
71937763|NCT02058628|143396546|SUPERIORITY_OR_OTHER|||||||0.0004||95.0||||Data is represented as per CTR.|Wilcoxon (Mann-Whitney)|DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.||||||0.0004
71937764|NCT01767597|143396559|SUPERIORITY_OR_OTHER|||||||0.5||||||No p-value adjustments for multiple comparisons were required. Significance was determined using a p-value \<0.05.|Chi-squared|||Power calculations were performed to detect \>15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that \~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As \~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.||||0.5
71692512|NCT04235504|142899844|SUPERIORITY||Mean Difference (Final Values)|-1.08|||||TWO_SIDED|95.0|-2.17|0.0||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.00|-2.17|
71937765|NCT04527471|143396601|OTHER|||||||1|TWO_SIDED|95.0|||||Fisher Exact|||||||1
71937766|NCT00096265|143396647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.43||||0.93|TWO_SIDED|95.0|0.89|2.31||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.31|0.89|0.93
71937767|NCT00096265|143396647|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.47||||0.95|TWO_SIDED|95.0|0.92|2.36||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.||2.36|0.92|0.95
71937768|NCT00096265|143396648|SUPERIORITY|||||||0.3|||||||Gray's test|||||||0.30
71937769|NCT00096265|143396648|SUPERIORITY|||||||0.48|||||||Gray's test|||||||0.48
71937770|NCT00096265|143396650|SUPERIORITY|||||||0.39|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.39
71937771|NCT00096265|143396650|SUPERIORITY|||||||0.28|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0702.||||0.28
71692513|NCT04235504|142899845|SUPERIORITY||Mean Difference (Final Values)|28.81|||||TWO_SIDED|95.0|12.34|45.28||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||45.28|12.34|
71937772|NCT00096265|143396651|SUPERIORITY|||||||0.002|||||||Chi-squared|||108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||0.002
71937773|NCT00096265|143396651|SUPERIORITY||||||<|0.001|||||||Chi-squared|||108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.0586.||||< 0.001
71937774|NCT00096265|143396652|SUPERIORITY|Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||||0.51|||||||Chi-squared|||||||0.51
71937775|NCT00096265|143396652|SUPERIORITY|||||||0.56|||||||Chi-squared|||Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/\[2(π2j-π1j)\], of 0.1217.||||0.56
71937776|NCT00096265|143396653|SUPERIORITY|||||||0.78|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.78
71937777|NCT00096265|143396653|SUPERIORITY|||||||0.8|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.||||0.80
71937778|NCT01506323|143396654|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.||||<.006
71937779|NCT01506323|143396654|SUPERIORITY_OR_OTHER||repeated measures||||<|0.031|TWO_SIDED|||||The p-value was adjusted for multiple comparisons using false discovery rate.|Mixed Models Analysis|This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.||This analysis is from baseline (week 0) to 2 months follow-up.||||<.031
71937780|NCT01506323|143396655|SUPERIORITY_OR_OTHER|||||||0.82|TWO_SIDED|||||The p-value is based on false discovery rate adjustment for multiple comparisons.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.||||0.82
71937781|NCT01506323|143396655|SUPERIORITY_OR_OTHER|||||||0.82|ONE_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment.||||0.82
71937782|NCT01506323|143396656|SUPERIORITY_OR_OTHER||||||<|0.008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.||||<0.008
71937783|NCT01506323|143396656|SUPERIORITY_OR_OTHER||||||<|0.09|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment||||<0.09
71937784|NCT01506323|143396657|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.||||<.006
71937785|NCT01506323|143396657|SUPERIORITY_OR_OTHER||||||<|0.03|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to 2 months post-treatment.||||<.03
71937786|NCT01506323|143396658|SUPERIORITY_OR_OTHER||||||<|0.0008|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.0008
71937787|NCT01506323|143396658|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Wilcoxon (Mann-Whitney)|||This analysis is from baseline to 2 months post-treatment.||||<0.006
71937788|NCT01506323|143396659|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was \<0.02.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.||||<0.10
71937789|NCT01506323|143396659|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment.||||<0.49
71937790|NCT01506323|143396660|SUPERIORITY_OR_OTHER||||||<|0.78|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.||||<0.78
71937791|NCT01506323|143396660|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.99
71937792|NCT01506323|143396661|SUPERIORITY_OR_OTHER||||||<|0.04|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.||||<0.04
71937793|NCT01506323|143396661|SUPERIORITY_OR_OTHER||||||<|0.25|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.25
71937794|NCT01506323|143396662|SUPERIORITY_OR_OTHER||||||<|0.99|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.||||<0.99
71937795|NCT01506323|143396662|SUPERIORITY_OR_OTHER||||||<|0.94|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.94
71937796|NCT01506323|143396663|SUPERIORITY_OR_OTHER||||||<|0.12|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.||||<0.12
71937797|NCT01506323|143396663|SUPERIORITY_OR_OTHER||||||<|0.49|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.||||<0.49
71937798|NCT01506323|143396664|SUPERIORITY_OR_OTHER||||||<|0.59|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.||||<0.59
71937799|NCT01506323|143396664|SUPERIORITY_OR_OTHER||||||<|0.1|TWO_SIDED|||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline to 2-months post-treatment.||||<0.10
71937800|NCT02891200|143396665|SUPERIORITY||Predicted Mean Difference|1.46||||0.467|TWO_SIDED|95.0|-2.47|5.38|||Mixed Models Analysis|Mixed effects linear model with study site and setting as fixed effects, and adjusted for baseline SGRQ domain scores.||||5.38|-2.47|0.467
71937801|NCT02637076|143396683|OTHER|||||||0.31|||||||repeated measures ANOVA|F(2,36)=1.26||||||0.31
71937802|NCT02637076|143396688|OTHER|||||||0.748|||||||repeated measures ANOVA|||||||0.748
71937803|NCT01633827|143396697|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.05|TWO_SIDED||||||t-test, 2 sided|||||||0.05
71937804|NCT01633827|143396698|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.025||||0.025|TWO_SIDED||||||t-test, 2 sided|||||||0.025
71937805|NCT01633827|143396699|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71937806|NCT01633827|143396700|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.5||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71937807|NCT01633827|143396701|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001||||0.001|TWO_SIDED||||||t-test, 2 sided|||||||0.001
71937808|NCT02637557|143396717|SUPERIORITY||LS Mean Difference|-2.952||||0.6065|TWO_SIDED|95.0|-14.222|8.318||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||8.318|-14.222|0.6065
71937809|NCT02637557|143396717|SUPERIORITY||LS Mean Difference|-9.036||||0.116|TWO_SIDED|95.0|-20.318|2.245||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||2.245|-20.318|0.1160
71937810|NCT02637557|143396717|SUPERIORITY||LS Mean Difference|-11.943||||0.04|TWO_SIDED|95.0|-23.334|-0.551||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.551|-23.334|0.0400
71937811|NCT02637557|143396717|SUPERIORITY|||||||0.0225||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0225
71937812|NCT02637557|143396718|SUPERIORITY||LS Mean Difference|-3.711||||0.4795|TWO_SIDED|95.0|-14.028|6.606||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||6.606|-14.028|0.4795
71937813|NCT02637557|143396718|SUPERIORITY||LS Mean Difference|-2.739||||0.602|TWO_SIDED|95.0|-13.066|7.588||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||7.588|-13.066|0.6020
71937814|NCT02637557|143396718|SUPERIORITY||LS Mean Difference|-8.602||||0.1055|TWO_SIDED|95.0|-19.03|1.826||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.826|-19.030|0.1055
71937815|NCT02637557|143396718|SUPERIORITY|||||||0.1387||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1387
71937816|NCT02637557|143396719|SUPERIORITY||LS Mean Difference|-0.058||||0.7488|TWO_SIDED|95.0|-0.415|0.299||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.299|-0.415|0.7488
71692514|NCT04235504|142899846|SUPERIORITY||Mean Difference (Final Values)|-28.45|||||TWO_SIDED|95.0|-45.27|-11.64||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||-11.64|-45.27|
71937817|NCT02637557|143396719|SUPERIORITY||LS Mean Difference|-0.254||||0.1627|TWO_SIDED|95.0|-0.611|0.103||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.103|-0.611|0.1627
71937818|NCT02637557|143396719|SUPERIORITY||LS Mean Difference|-0.417||||0.0237|TWO_SIDED|95.0|-0.777|-0.056||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||-0.056|-0.777|0.0237
71937819|NCT02637557|143396719|SUPERIORITY|||||||0.013||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.0130
71937820|NCT02637557|143396720|SUPERIORITY||LS Mean Difference|-0.052||||0.747|TWO_SIDED|95.0|-0.369|0.265||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.265|-0.369|0.7470
71937821|NCT02637557|143396720|SUPERIORITY||LS Mean Difference|-0.047||||0.7699|TWO_SIDED|95.0|-0.364|0.27||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.270|-0.364|0.7699
71937822|NCT02637557|143396720|SUPERIORITY||LS Mean Difference|-0.257||||0.1157|TWO_SIDED|95.0|-0.577|0.064||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.064|-0.577|0.1157
71937823|NCT02637557|143396720|SUPERIORITY|||||||0.1374||||||Dose trend test performed using linear contrast statement.|trend test|||||||0.1374
71937824|NCT02637557|143396721|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7903|TWO_SIDED|95.0|0.47|1.77||Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.77|0.47|0.7903
71937825|NCT02637557|143396721|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3518|TWO_SIDED|95.0|0.7|2.71||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.71|0.70|0.3518
71692515|NCT04235504|142899847|SUPERIORITY||Mean Difference (Final Values)|-0.36|||||TWO_SIDED|95.0|-1.32|0.59||Due to the small sample size, p value will not be meaningful. Therefore, p value is not presented|linear mixed model|||||0.59|-1.32|
71692516|NCT00870467|142899858|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71692517|NCT00870467|142899859|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71692518|NCT00870467|142899860|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71692519|NCT00870467|142899861|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71692520|NCT00870467|142899862|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.001
71692521|NCT00870467|142899863|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||||||<0.001
71937826|NCT02637557|143396721|SUPERIORITY||Odds Ratio (OR)|1.64||||0.1544|TWO_SIDED|95.0|0.83|3.26||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.26|0.83|0.1544
71937827|NCT02637557|143396722|SUPERIORITY||Odds Ratio (OR)|0.56||||0.1489|TWO_SIDED|95.0|0.25|1.23||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||1.23|0.25|0.1489
71937828|NCT02637557|143396722|SUPERIORITY||Odds Ratio (OR)|1.05||||0.8891|TWO_SIDED|95.0|0.51|2.19||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||2.19|0.51|0.8891
71937829|NCT02637557|143396722|SUPERIORITY||Odds Ratio (OR)|1.56||||0.2237|TWO_SIDED|95.0|0.76|3.2||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.20|0.76|0.2237
71937830|NCT02637557|143396723|SUPERIORITY||Odds Ratio (OR)|1.24||||0.6566|TWO_SIDED|95.0|0.48|3.18||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||3.18|0.48|0.6566
71937831|NCT02637557|143396723|SUPERIORITY||Odds Ratio (OR)|2.01||||0.128|TWO_SIDED|95.0|0.81|4.98||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.98|0.81|0.1280
71937832|NCT02637557|143396723|SUPERIORITY||Odds Ratio (OR)|1.97||||0.1463|TWO_SIDED|95.0|0.79|4.91||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel|||||4.91|0.79|0.1463
71937833|NCT02637557|143396724|SUPERIORITY||LS Mean Difference|-0.298||||0.5504|TWO_SIDED|95.0|-1.279|0.683||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.683|-1.279|0.5504
71937834|NCT02637557|143396724|SUPERIORITY||LS Mean Difference|0.252||||0.6177|TWO_SIDED|95.0|-0.741|1.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.244|-0.741|0.6177
71937835|NCT02637557|143396724|SUPERIORITY||LS Mean Difference|0.513||||0.3138|TWO_SIDED|95.0|-0.488|1.513||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.513|-0.488|0.3138
71937836|NCT02637557|143396725|SUPERIORITY||LS Mean Difference|0.019||||0.9675|TWO_SIDED|95.0|-0.897|0.935||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.935|-0.897|0.9675
71937837|NCT02637557|143396725|SUPERIORITY||LS Mean Difference|0.419||||0.3741|TWO_SIDED|95.0|-0.507|1.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.345|-0.507|0.3741
71937838|NCT02637557|143396725|SUPERIORITY||LS Mean Difference|0.461||||0.3275|TWO_SIDED|95.0|-0.464|1.385||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||1.385|-0.464|0.3275
71937839|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.023||||0.856|TWO_SIDED|95.0|-0.226|0.272||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.272|-0.226|0.8560
71937840|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.124||||0.3301|TWO_SIDED|95.0|-0.126|0.373||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.373|-0.126|0.3301
71937841|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.019||||0.8845|TWO_SIDED|95.0|-0.27|0.233||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.233|-0.270|0.8845
71937842|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.02||||0.8879|TWO_SIDED|95.0|-0.262|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.303|-0.262|0.8879
71937843|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.017||||0.9072|TWO_SIDED|95.0|-0.266|0.299||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.299|-0.266|0.9072
71937844|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.108||||0.4573|TWO_SIDED|95.0|-0.393|0.177||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.177|-0.393|0.4573
71937845|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.049||||0.7476|TWO_SIDED|95.0|-0.35|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.251|-0.350|0.7476
71692522|NCT02106351|142899873|SUPERIORITY||LS mean difference back transformed|-0.4||||0.0118|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of covariance (ANCOVA) on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived least squares (LS) means were back transformed to the original scale and the treatment difference determined.||||0.0118
71692523|NCT02106351|142899873|SUPERIORITY||LS mean difference back transformed|-0.7|||<|0.0001|TWO_SIDED|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANCOVA on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||<0.0001
71692524|NCT02106351|142899874|SUPERIORITY||LS mean difference back transformed|0.2||||0.2043|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of variance (ANOVA) on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.2043
71692525|NCT02106351|142899874|SUPERIORITY||LS mean difference back transformed|0.2||||0.188|TWO_SIDED|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANOVA on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.||||0.1880
71692526|NCT02106351|142899875|SUPERIORITY||LS mean difference|0.5||||0.7648|TWO_SIDED|95.0|-2.7|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.7|0.7648
71692527|NCT02106351|142899875|SUPERIORITY||LS mean difference|0.5||||0.7429|TWO_SIDED|95.0|-2.6|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.||3.7|-2.6|0.7429
71937846|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.062||||0.6873|TWO_SIDED|95.0|-0.362|0.239||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.239|-0.362|0.6873
71937847|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.258||||0.0952|TWO_SIDED|95.0|-0.562|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.045|-0.562|0.0952
71692528|NCT00069823|142899896|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.2||||0.35|TWO_SIDED|95.0|0.8|2.0||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||2.0|0.8|0.35
71692529|NCT00069823|142899897|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.79|TWO_SIDED|95.0|0.6|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.6|0.79
71692530|NCT00069823|142899898|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.1||||0.66|TWO_SIDED|95.0|0.8|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.||1.5|0.8|0.66
71692531|NCT00069823|142899899|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62|TWO_SIDED|95.0|0.6|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.6|0.62
71692532|NCT00069823|142899900|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|1.0||||0.87|TWO_SIDED|95.0|0.8|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.8|0.87
71937848|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.018||||0.9111|TWO_SIDED|95.0|-0.326|0.291||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.291|-0.326|0.9111
71692533|NCT00069823|142899901|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.62||95.0|0.7|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.3|0.7|0.62
71692534|NCT00069823|142899902|SUPERIORITY_OR_OTHER||Incidence-Rate Ratio|0.9||||0.7|TWO_SIDED|95.0|0.6|1.4||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.||1.4|0.6|0.70
71692535|NCT00069823|142899903|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.36|TWO_SIDED|95.0|-0.03|0.08||P values were calculated with the use of linear regression.|Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00 - (-0.02) = -0.03 (rounding)|The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group||0.08|-0.03|0.36
71692536|NCT00069823|142899904|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3|TWO_SIDED|95.0|-0.03|0.09|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.09|-0.03|0.30
71692537|NCT00069823|142899905|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.0|STANDARD_ERROR_OF_MEAN|5.1||0.24|TWO_SIDED|95.0|-4.0|16.0|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||16.0|-4.0|0.24
71692538|NCT00069823|142899906|SUPERIORITY_OR_OTHER||Treatment Effect|-1.8||||0.04||95.0|-3.6|-0.1|||Regression, Linear|||||-0.1|-3.6|0.04
71692539|NCT00069823|142899907|SUPERIORITY_OR_OTHER||Treatment Effect|0.1|STANDARD_ERROR_OF_MEAN|0.1||0.11|TWO_SIDED|95.0|0.0|0.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.2|0.0|0.11
71692540|NCT00069823|142899908|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.01||0.11|TWO_SIDED|95.0|-0.05|-0.02|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||-0.02|-0.05|0.11
71692541|NCT00069823|142899909|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.33|TWO_SIDED|95.0|-0.2|0.1|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.1|-0.2|0.33
71692542|NCT00069823|142899910|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.6||0.16|TWO_SIDED|95.0|-2.0|0.4|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.4|-2.0|0.16
71692543|NCT00069823|142899911|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_ERROR_OF_MEAN|0.78||0.56|TWO_SIDED|95.0|-1.1|2.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||2.2|-1.1|0.56
71692544|NCT00069823|142899912|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.76|TWO_SIDED|95.0|-0.05|0.07|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.07|-0.05|0.76
71692545|NCT00069823|142899913|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.39|TWO_SIDED|95.0|-0.8|0.3|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group|||0.3|-0.8|0.39
71692546|NCT01801111|142899925|OTHER|||||||0.0005|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the objective response rate (ORR) is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0005
71692547|NCT01801111|142899926|OTHER|||||||0.0599|TWO_SIDED||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0599
71692548|NCT01801111|142899928|OTHER|||||||0.0001|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.||||0.0001
71692549|NCT01223937|142899963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.028|TWO_SIDED|95.0|-0.42|-0.02||A priori threshold for significance was p\<=0.05.|ANCOVA|Repeated measures ANCOVA with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||"The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."||-0.02|-0.42|0.0280
71692550|NCT01223937|142899964|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.85||||0.0061|TWO_SIDED|95.0|1.19|2.86||A priori threshold for significance was p\<=0.05.|Generalized Estimating Equation (GEE)|GEE Method with treatment, visit (including a treatment-by-visit interaction term), and age stratification (\<65, ≥65 years) as factors.||The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.||2.86|1.19|0.0061
71692551|NCT01223937|142899965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3||||0.0104|TWO_SIDED|95.0|-0.54|-0.07||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal voids, using last observation carried forward.||Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.||-0.07|-0.54|0.0104
71692552|NCT01223937|142899966|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73||||0.0586|TWO_SIDED|95.0|0.98|3.05||A priori threshold for significance was p\<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (\<65, \>=65) and baseline nocturnal voids using last observation carried forward.||||3.05|0.98|0.0586
71692553|NCT01223937|142899967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|49.03||||0.0034|TWO_SIDED|95.0|16.35|81.7||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline time to first nocturnal void, using last observation carried forward.||||81.70|16.35|0.0034
71692554|NCT01223937|142899968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-83.56||||0.0031|TWO_SIDED|95.0|-138.74|-28.38||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline nocturnal urine volume, using last observation carried forward.||||-28.38|-138.74|0.0031
71692555|NCT01223937|142899969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-72.91||||0.1829|TWO_SIDED|95.0|-180.42|34.6||A priori threshold for significance was p\<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (\<65, \>=65) and baseline 24-hour urine volume, using last observation carried forward.||||34.60|-180.42|0.1829
71692556|NCT03284853|142899987|OTHER|The primary analysis was performed on the ITT population with imputation by Markov Chain Monte Carlo method.|||||<|0.05||||||Linear model with IOP at the given visit and time point as the response, baseline IOP as a covariate, and treatment as a main effect factor at each time point (08:00, 10:00, and 16:00 hours at the Week 2, Week 6, and Month 3 Visits).|Regression, Linear|Non-inferiority for PG324 was concluded if the UL of the 95% CI was ≤ l.5 mmHg at all 9 time points and ≤ l.0 mmHg at the majority of time points||Assuming no difference between PG324 and Ganfort, a two-tailed alpha of 0.05 (2-sided 95% CI) at each of 9 time points, a common SD of 3.5 mmHg, and a correlation between time points of ≤ 0.60, 200 ITT subjects per arm were necessary to have 85% power to show clinical non-inferiority of PG324 to Ganfort in the mean change from baseline IOP.||||<0.05
71692557|NCT00255164|142899997|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71692558|NCT00255164|142899997|SUPERIORITY_OR_OTHER||||||<|1e-05||||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact|||||||<0.00001
71692559|NCT00255164|142899997|SUPERIORITY_OR_OTHER|||||||0.80473||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact|||||||0.80473
71692560|NCT00255164|142899998|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71692561|NCT00255164|142899998|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71692562|NCT00255164|142899998|SUPERIORITY_OR_OTHER|||||||0.76046||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.76046
71692563|NCT00255164|142900000|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71692564|NCT00255164|142900000|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank|||||||<0.00001
71692565|NCT00255164|142900000|SUPERIORITY_OR_OTHER|||||||0.37161||95.0||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank|||||||0.37161
71692566|NCT00255164|142900001|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71692567|NCT00255164|142900001|SUPERIORITY_OR_OTHER||||||<|1e-05||95.0||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)|||||||<0.00001
71692568|NCT00255164|142900001|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||||||0.59700
71692569|NCT00814138|142900011|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-488.0||||0.26|TWO_SIDED|95.0|-2443.4|1467.3|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||1467.3|-2443.4|0.26
71692570|NCT00814138|142900012|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.9||||0.26|TWO_SIDED|95.0|-9.7|5.8|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.8|-9.7|0.26
71937849|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.004||||0.9772|TWO_SIDED|95.0|-0.304|0.313||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.313|-0.304|0.9772
71937850|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.235||||0.139|TWO_SIDED|95.0|-0.546|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.546|0.1390
71937851|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.017||||0.9215|TWO_SIDED|95.0|-0.349|0.316||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.316|-0.349|0.9215
71937852|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.055||||0.7453|TWO_SIDED|95.0|-0.388|0.278||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.278|-0.388|0.7453
71937853|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.393||||0.022|TWO_SIDED|95.0|-0.729|-0.057||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.057|-0.729|0.0220
71937854|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.053||||0.7561|TWO_SIDED|95.0|-0.282|0.387||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.387|-0.282|0.7561
71937855|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.071||||0.6758|TWO_SIDED|95.0|-0.406|0.263||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.263|-0.406|0.6758
71937856|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.348||||0.0434|TWO_SIDED|95.0|-0.686|-0.01||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.010|-0.686|0.0434
71937857|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|0.042||||0.8123|TWO_SIDED|95.0|-0.308|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.392|-0.308|0.8123
71937858|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.044||||0.8038|TWO_SIDED|95.0|-0.394|0.306||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.306|-0.394|0.8038
71937859|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.3||||0.0954|TWO_SIDED|95.0|-0.654|0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.053|-0.654|0.0954
71937860|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.078||||0.6649|TWO_SIDED|95.0|-0.43|0.275||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.275|-0.430|0.6649
71937861|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.262||||0.1448|TWO_SIDED|95.0|-0.614|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.091|-0.614|0.1448
71937862|NCT02637557|143396726|SUPERIORITY||LS Mean Difference|-0.403||||0.0264|TWO_SIDED|95.0|-0.759|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.759|0.0264
71937863|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|0.102||||0.4137|TWO_SIDED|95.0|-0.143|0.347||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.347|-0.143|0.4137
71692571|NCT00814138|142900013|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7||||0.29|TWO_SIDED|95.0|-4.9|1.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.5|-4.9|0.29
71692572|NCT00814138|142900014|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.28|TWO_SIDED|95.0|-6.3|1.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||1.8|-6.3|0.28
71937864|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|0.147||||0.2395|TWO_SIDED|95.0|-0.098|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.392|-0.098|0.2395
71937865|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.036||||0.7729|TWO_SIDED|95.0|-0.284|0.212||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.212|-0.284|0.7729
71937866|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|0.079||||0.5824|TWO_SIDED|95.0|-0.205|0.363||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.363|-0.205|0.5824
71937867|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|0.028||||0.8466|TWO_SIDED|95.0|-0.256|0.312||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.312|-0.256|0.8466
71937868|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.118||||0.4192|TWO_SIDED|95.0|-0.405|0.169||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.169|-0.405|0.4192
71937869|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.035||||0.8192|TWO_SIDED|95.0|-0.333|0.264||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.264|-0.333|0.8192
71937870|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.073||||0.632|TWO_SIDED|95.0|-0.372|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.226|-0.372|0.6320
71692573|NCT00814138|142900015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.82|TWO_SIDED|95.0|-7.2|5.4|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.||5.4|-7.2|0.82
71692574|NCT00814138|142900016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.21|TWO_SIDED|95.0|-3.7|0.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.8|-3.7|0.21
71692575|NCT00814138|142900017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.09|TWO_SIDED|95.0|-7.1|0.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.||0.5|-7.1|0.09
71692576|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.|Least Squares (LS) Mean Difference|32.4|||||TWO_SIDED|90.0|28.4|36.4||||||||36.4|28.4|
71692577|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|15.6|||||TWO_SIDED|90.0|11.7|19.6||||||||19.6|11.7|
71692578|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|20.3|||||TWO_SIDED|90.0|16.3|24.3||||||||24.3|16.3|
71692579|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|23.6|||||TWO_SIDED|90.0|19.6|27.6||||||||27.6|19.6|
71692580|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.|LS Mean Difference|16.8|||||TWO_SIDED|90.0|12.8|20.8||||||||20.8|12.8|
71937871|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.345||||0.0254|TWO_SIDED|95.0|-0.647|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.043|-0.647|0.0254
71937872|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.047||||0.7689|TWO_SIDED|95.0|-0.36|0.266||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.266|-0.360|0.7689
71937873|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.117||||0.4631|TWO_SIDED|95.0|-0.43|0.196||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.196|-0.430|0.4631
71937874|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.298||||0.0651|TWO_SIDED|95.0|-0.615|0.019||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.019|-0.615|0.0651
71692581|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.|LS Mean Difference|12.1|||||TWO_SIDED|90.0|8.1|16.1||||||||16.1|8.10|
71692582|NCT03286218|142900029|NON_INFERIORITY|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.|LS Mean Difference|8.79|||||TWO_SIDED|90.0|4.8|12.8||||||||12.8|4.8|
71692583|NCT03286218|142900032|OTHER||LS Mean Difference|33.1|||||TWO_SIDED|90.0|28.5|37.7||||||Overall Drug Liking||37.7|28.5|
71692584|NCT03286218|142900032|OTHER||LS Mean Difference|18.6|||||TWO_SIDED|90.0|14.0|23.2||||||Overall Drug Liking||23.2|14.0|
71692585|NCT03286218|142900032|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.5|23.8||||||Overall Drug Liking||23.8|14.5|
71692586|NCT03286218|142900032|OTHER||LS Mean Difference|24.3|||||TWO_SIDED|90.0|19.7|28.9||||||Overall Drug Liking||28.9|19.7|
71692587|NCT03286218|142900032|OTHER||LS Mean Difference|34.0|||||TWO_SIDED|90.0|29.1|38.9||||||Take drug again||38.9|29.1|
71692588|NCT03286218|142900032|OTHER||LS Mean Difference|19.1|||||TWO_SIDED|90.0|14.2|24.0||||||Take drug again||24.0|14.2|
71937875|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.06||||0.7197|TWO_SIDED|95.0|-0.392|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.271|-0.392|0.7197
71937876|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.097||||0.5649|TWO_SIDED|95.0|-0.428|0.234||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.234|-0.428|0.5649
71937877|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.422||||0.0138|TWO_SIDED|95.0|-0.757|-0.087||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.087|-0.757|0.0138
71937878|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|0.06||||0.7202|TWO_SIDED|95.0|-0.269|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.388|-0.269|0.7202
71692589|NCT03286218|142900032|OTHER||LS Mean Difference|20.6|||||TWO_SIDED|90.0|15.7|25.6||||||Take drug again||25.6|15.7|
71692590|NCT03286218|142900032|OTHER||LS Mean Difference|25.3|||||TWO_SIDED|90.0|20.3|30.2||||||Take drug again||30.2|20.3|
71692591|NCT03286218|142900032|OTHER||LS Mean Difference|69.7|||||TWO_SIDED|90.0|62.1|77.4||||||Good effects||77.4|62.1|
71692592|NCT03286218|142900032|OTHER||LS Mean Difference|35.5|||||TWO_SIDED|90.0|27.9|43.2||||||Good effects||43.2|27.9|
71692593|NCT03286218|142900032|OTHER||LS Mean Difference|52.0|||||TWO_SIDED|90.0|44.4|59.7||||||Good effects||59.7|44.4|
71692594|NCT03286218|142900032|OTHER||LS Mean Difference|53.0|||||TWO_SIDED|90.0|45.4|60.6||||||Good effects||60.6|45.4|
71692595|NCT03286218|142900032|OTHER||LS Mean Difference|20.4|||||TWO_SIDED|90.0|13.6|27.2||||||Bad effects||27.2|13.6|
71692596|NCT03286218|142900032|OTHER||LS Mean Difference|5.04|||||TWO_SIDED|90.0|-1.76|11.8||||||Bad effects||11.8|-1.76|
71692597|NCT03286218|142900032|OTHER||LS Mean Difference|7.28|||||TWO_SIDED|90.0|0.487|14.1||||||Bad effects||14.1|0.487|
71692598|NCT03286218|142900032|OTHER||LS Mean Difference|12.5|||||TWO_SIDED|90.0|5.69|19.3||||||Bad effects||19.3|5.69|
71937879|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.093||||0.5784|TWO_SIDED|95.0|-0.421|0.236||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.236|-0.421|0.5784
71937880|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.376||||0.0266|TWO_SIDED|95.0|-0.708|-0.044||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.044|-0.708|0.0266
71937881|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.049||||0.777|TWO_SIDED|95.0|-0.391|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.293|-0.391|0.7770
71937882|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.114||||0.5121|TWO_SIDED|95.0|-0.456|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.228|-0.456|0.5121
71937883|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.366||||0.0384|TWO_SIDED|95.0|-0.711|-0.02||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.020|-0.711|0.0384
71937884|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.093||||0.5876|TWO_SIDED|95.0|-0.431|0.245||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.245|-0.431|0.5876
71692599|NCT03286218|142900032|OTHER||LS Mean Difference|75.4|||||TWO_SIDED|90.0|67.2|83.5||||||Any effects||83.5|67.2|
71937885|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.298||||0.0842|TWO_SIDED|95.0|-0.636|0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.040|-0.636|0.0842
71937886|NCT02637557|143396727|SUPERIORITY||LS Mean Difference|-0.452||||0.0098|TWO_SIDED|95.0|-0.793|-0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.110|-0.793|0.0098
71937887|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|0.054||||0.6663|TWO_SIDED|95.0|-0.193|0.301||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.301|-0.193|0.6663
71692600|NCT03286218|142900032|OTHER||LS Mean Difference|44.9|||||TWO_SIDED|90.0|36.8|53.0||||||Any effects||53.0|36.8|
71692601|NCT03286218|142900032|OTHER||LS Mean Difference|56.8|||||TWO_SIDED|90.0|48.7|64.9||||||Any effects||64.9|48.7|
71692602|NCT03286218|142900032|OTHER||LS Mean Difference|64.8|||||TWO_SIDED|90.0|56.7|73.0||||||Any effects||73.0|56.7|
71937888|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|0.148||||0.24|TWO_SIDED|95.0|-0.1|0.396||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.396|-0.100|0.2400
71937889|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.023||||0.856|TWO_SIDED|95.0|-0.273|0.227||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.227|-0.273|0.8560
71692603|NCT03286218|142900032|OTHER||LS Mean Difference|68.6|||||TWO_SIDED|90.0|60.6|76.6||||||High||76.6|60.6|
71692604|NCT03286218|142900032|OTHER||LS Mean Difference|34.4|||||TWO_SIDED|90.0|26.4|42.4||||||High||42.4|26.4|
71692605|NCT03286218|142900032|OTHER||LS Mean Difference|47.5|||||TWO_SIDED|90.0|39.5|55.5||||||High||55.5|39.5|
71692606|NCT03286218|142900032|OTHER||LS Mean Difference|58.4|||||TWO_SIDED|90.0|50.4|66.3||||||High||66.3|50.4|
71692607|NCT03286218|142900033|SUPERIORITY||Mean Difference (Final Values)|0.0|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71692608|NCT03286218|142900033|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0781|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0781
71692609|NCT03286218|142900033|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0625|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71692610|NCT03286218|142900033|SUPERIORITY||Median Difference (Final Values)|0.0||||0.0098|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.0098
71692611|NCT03286218|142900034|OTHER||LS Mean Difference|-29.9|||||TWO_SIDED|90.0|-34.0|-25.9||||||Alertness/drowsiness||-25.9|-34.0|
71937890|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|0.051||||0.7209|TWO_SIDED|95.0|-0.232|0.335||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.335|-0.232|0.7209
71692612|NCT03286218|142900034|OTHER||LS Mean Difference|-16.9|||||TWO_SIDED|90.0|-20.9|-12.8||||||Alertness/drowsiness||-12.8|-20.9|
71692613|NCT03286218|142900034|OTHER||LS Mean Difference|-19.6|||||TWO_SIDED|90.0|-23.6|-15.5||||||Alertness/drowsiness||-15.5|-23.6|
71692614|NCT03286218|142900034|OTHER||LS Mean Difference|-24.8|||||TWO_SIDED|90.0|-28.8|-20.8||||||Alertness/drowsiness||-20.8|-28.8|
71692615|NCT03286218|142900034|OTHER||LS Mean Difference|-30.8|||||TWO_SIDED|90.0|-35.0|-26.5||||||Agitation/relaxation||-26.5|-35.0|
71692616|NCT03286218|142900034|OTHER||LS Mean Difference|-19.5|||||TWO_SIDED|90.0|-23.7|-15.3||||||Agitation/relaxation||-15.3|-23.7|
71692617|NCT03286218|142900034|OTHER||LS Mean Difference|-21.7|||||TWO_SIDED|90.0|-25.9|-17.5||||||Agitation/relaxation||-17.5|-25.9|
71692618|NCT03286218|142900034|OTHER||LS Mean Difference|-28.8|||||TWO_SIDED|90.0|-33.0|-24.5||||||Agitation/relaxation||-24.5|-33.0|
71692619|NCT02762084|142900048|OTHER|Pairwise comparison||||||0.03|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.030
71692620|NCT02762084|142900048|OTHER|Pairwise comparison||||||0.756|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26||||0.756
71692621|NCT02762084|142900049|OTHER|Pairwise comparison||||||0.5|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.500
71692622|NCT02762084|142900049|OTHER|Pairwise comparison||||||0.681|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6||||0.681
71692623|NCT02762084|142900053|OTHER|One-sided comparison||||||0.048|||||||Mann Whitey U|||at Week 26||||0.048
71692624|NCT02762084|142900053|OTHER|Two-sided comparison||||||0.096|||||||Mann Whitey U|||at Week 26||||0.096
71692625|NCT02762084|142900054|OTHER|Two-sided comparison||||||0.008|||||||Mann Whitey U|||at Week 26||||0.008
71692626|NCT01619852|142900082|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
71692627|NCT01619852|142900083|SUPERIORITY_OR_OTHER_LEGACY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71692628|NCT01619852|142900084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||||||0.68
71692629|NCT01619852|142900084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-Sensory-discriminative dimension||||0.69
71692630|NCT01619852|142900084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-affective dimension||||0.75
71692631|NCT01619852|142900084|SUPERIORITY_OR_OTHER_LEGACY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Brief Pain Inventory||||0.81
71692632|NCT01619852|142900085|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||||||.19
71692633|NCT01619852|142900086|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||.29
71692634|NCT02168491|142900096|SUPERIORITY_OR_OTHER||||||<|0.02|||||||paired t test|||||||<0.02
71692635|NCT02168491|142900097|SUPERIORITY_OR_OTHER|||||||0.24|||||||paired t test|||||||0.24
71692636|NCT02168491|142900098|SUPERIORITY_OR_OTHER|||||||0.28|||||||paired t test|||||||0.28
71692637|NCT01096160|142900101|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-7.08||||0.1194|TWO_SIDED|90.0|-17.1|2.92|||Linear mixed effects model|||||2.92|-17.1|0.1194
71692638|NCT01096160|142900101|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-13.1||||0.0224|TWO_SIDED|90.0|-23.7|-2.48|||Linear mixed effects model|||||-2.48|-23.7|0.0224
71692639|NCT01096160|142900101|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|0.33||||0.4791|TWO_SIDED|90.0|-10.3|10.91|||Linear mixed effects model|||||10.91|-10.3|0.4791
71692640|NCT01096160|142900101|OTHER|Difference in change from baseline in SBP (TWA\^0-24hrs)|Mean Difference (Final Values)|-8.21||||0.0705|TWO_SIDED|90.0|-17.4|1.01|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.01|-17.4|0.0705
71692641|NCT01096160|142900102|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|3.85||||0.1161|TWO_SIDED|90.0|-1.51|9.22|||Linear mixed effects model|||||9.22|-1.51|0.1161
71692642|NCT01096160|142900102|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|7.28||||0.0189|TWO_SIDED|90.0|1.6|12.97|||Linear mixed effects model|||||12.97|1.60|0.0189
71692643|NCT01096160|142900102|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|0.26||||0.4689|TWO_SIDED|90.0|-5.42|5.95|||Linear mixed effects model|||||5.95|-5.42|0.4689
71937891|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.013||||0.9283|TWO_SIDED|95.0|-0.297|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.271|-0.297|0.9283
71692644|NCT01096160|142900102|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|4.06||||0.0869|TWO_SIDED|90.0|-0.89|9.01|||Linear mixed effects model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||9.01|-0.89|0.0869
71692645|NCT01096160|142900103|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-9.87||||0.003|TWO_SIDED|90.0|-15.7|-4.09|||Linear mixed effects model|||||-4.09|-15.7|0.003
71692646|NCT01096160|142900103|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-11.2||||0.002|TWO_SIDED|90.0|-17.3|-5.1|||Linear mixed effects model|||||-5.10|-17.3|0.002
71692647|NCT01096160|142900103|OTHER|Comparison of Day 10 values (TWA\^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-5.18||||0.08|TWO_SIDED|90.0|-11.3|0.95|||Linear mixed effcts model|||||0.95|-11.3|0.080
71692648|NCT01096160|142900103|OTHER|Difference in change from baseline in AIx (TWA\^0-24hrs)|Mean Difference (Final Values)|-6.79||||0.019|TWO_SIDED|90.0|-12.1|-1.46|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||-1.46|-12.1|0.019
71692649|NCT01096160|142900104|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.28||||0.318|TWO_SIDED|90.0|0.53|3.05|||Linear mixed effects model|||||3.05|0.53|0.318
71692650|NCT01096160|142900104|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.66||||0.17|TWO_SIDED|90.0|0.66|4.17|||Linear mixed effects model|||||4.17|0.66|0.17
71692651|NCT01096160|142900104|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.41||||0.054|TWO_SIDED|90.0|0.16|1.02|||Linear mixed effcts model|||||1.02|0.16|0.054
71937892|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.162||||0.2659|TWO_SIDED|95.0|-0.449|0.124||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.124|-0.449|0.2659
71692652|NCT01096160|142900104|OTHER|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.78||||0.297|TWO_SIDED|90.0|0.35|1.73|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.||1.73|0.35|0.297
71692653|NCT00705757|142900128|SUPERIORITY_OR_OTHER|||||||0.769|TWO_SIDED||||||ANOVA|||One way ANOVA of Upper Lid||||0.769
71692654|NCT00705757|142900128|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of Lower Lid||||0.230
71692655|NCT00705757|142900128|SUPERIORITY_OR_OTHER|||||||0.851|TWO_SIDED|95.0|||||ANOVA|||One way ANOVA of cheek/face||||0.851
71692656|NCT03193047|142900129|SUPERIORITY||Least squares mean difference|-30.261|STANDARD_ERROR_OF_MEAN|5.502|<|0.001|TWO_SIDED|95.0|-41.324|-19.199|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-19.199|-41.324|<0.001
71692657|NCT03193047|142900130|SUPERIORITY||Lease squares mean difference|-35.884|STANDARD_ERROR_OF_MEAN|5.159|<|0.001|TWO_SIDED|95.0|-46.303|-25.466|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|||-25.466|-46.303|<0.001
71692658|NCT03193047|142900131|SUPERIORITY||Least squares mean difference|-38.25|STANDARD_ERROR_OF_MEAN|5.602|<|0.001|TWO_SIDED|95.0|-49.558|-26.944|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 1||-26.944|-49.558|<0.001
71692659|NCT03193047|142900131|SUPERIORITY||Least squares mean difference|-29.9|STANDARD_ERROR_OF_MEAN|5.606|<|0.001|TWO_SIDED|95.0|-41.176|-18.626|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 2||-18.626|-41.176|<0.001
71692660|NCT03193047|142900132|SUPERIORITY||Least squares mean difference|-27.031|STANDARD_ERROR_OF_MEAN|5.15|<|0.001|TWO_SIDED|95.0|-37.509|-16.553|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 1||-16.553|-37.509|<0.001
71692661|NCT03193047|142900132|SUPERIORITY||Least squares mean difference|-24.469|STANDARD_ERROR_OF_MEAN|4.33|<|0.001|TWO_SIDED|95.0|-33.225|-15.713|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 2||-15.713|-33.225|<0.001
71692662|NCT03193047|142900132|SUPERIORITY||Least squares mean difference|-31.64|STANDARD_ERROR_OF_MEAN|4.689|<|0.001|TWO_SIDED|95.0|-41.116|-22.163|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 1||-22.163|-41.116|<0.001
71692663|NCT03193047|142900132|SUPERIORITY||Least squares mean difference|-24.246|STANDARD_ERROR_OF_MEAN|4.838|<|0.001|TWO_SIDED|95.0|-33.987|-14.505|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 2||-14.505|-33.987|<0.001
71692664|NCT03193047|142900132|SUPERIORITY||Least squares mean difference|-21.941|STANDARD_ERROR_OF_MEAN|3.572|<|0.001|TWO_SIDED|95.0|-29.153|-14.729|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 1||-14.729|-29.153|<0.001
71692665|NCT03193047|142900132|SUPERIORITY||Least squares mean difference|-17.52|STANDARD_ERROR_OF_MEAN|3.809|<|0.001|TWO_SIDED|95.0|-25.201|-9.839|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 2||-9.839|-25.201|<0.001
71692666|NCT03193047|142900133|SUPERIORITY||Median treatment difference|-32.479|STANDARD_ERROR_OF_MEAN|17.395||0.046|TWO_SIDED|95.0|-70.524|-2.339|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 1||-2.339|-70.524|0.046
71692667|NCT03193047|142900133|SUPERIORITY||Median treatment difference|-28.512|STANDARD_ERROR_OF_MEAN|12.124||0.029|TWO_SIDED|95.0|-51.455|-3.93|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 2||-3.930|-51.455|0.029
71692668|NCT00186485|142900169|SUPERIORITY_OR_OTHER||||||<|0.001||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the HAM-D rating scale: total scores (F (4,96) = 19.88, p \< .001) over the 4 week treatment period.|ANOVA|Repeated Measures Anova||ANOVA with partial eta accounts for multiple repeated measures over the course of treatment.||||<0.001
71692669|NCT00186485|142900170|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the BDI total scores (F (4,96) = 19.35, p \< .001) over the 4 week treatment period.,|ANOVA|||Repeated measures ANOVA with partial eta; accounts for multiple repeated measures over the course of treatment.||||<0.01
71937893|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.006||||0.968|TWO_SIDED|95.0|-0.31|0.298||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.298|-0.310|0.9680
71937894|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.125||||0.4213|TWO_SIDED|95.0|-0.429|0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.180|-0.429|0.4213
71937895|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.311||||0.0471|TWO_SIDED|95.0|-0.618|-0.004||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.004|-0.618|0.0471
71692670|NCT00186485|142900171|SUPERIORITY_OR_OTHER||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the CGI scores (F (4,88) = 5.31, p \< .01) over the 4 week treatment period.|ANOVA|||Repeated Measures ANOVA with partial eta; p value was adjusted for multiple comparisons over the course of treatment||||<0.01
71692671|NCT02533934|142900174|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
71937896|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.025||||0.8769|TWO_SIDED|95.0|-0.337|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.288|-0.337|0.8769
71937897|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.059||||0.7109|TWO_SIDED|95.0|-0.372|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.254|-0.372|0.7109
71692672|NCT02533934|142900174|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.01|||||||Kruskal-Wallis|||APRI change from baseline to last follow-up||||<.01
71692673|NCT02533934|142900174|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
71692674|NCT02533934|142900174|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance|||||<|0.01|||||||Kruskal-Wallis|||FIB4 change from baseline to last follow-up||||<.01
71692675|NCT02533934|142900176|EQUIVALENCE|Equivalence margin is defined by the a priori threshold for statistical significance.|||||<|0.001|||||||Wilcoxon (Signed Rank Test)|||||||<0.001
71937898|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.254||||0.1146|TWO_SIDED|95.0|-0.57|0.062||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.062|-0.570|0.1146
71937899|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|0.048||||0.7736|TWO_SIDED|95.0|-0.281|0.378||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.378|-0.281|0.7736
71937900|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.02||||0.9059|TWO_SIDED|95.0|-0.35|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.310|-0.350|0.9059
71937901|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.299||||0.0779|TWO_SIDED|95.0|-0.633|0.034||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.034|-0.633|0.0779
71937902|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|0.086||||0.6068|TWO_SIDED|95.0|-0.241|0.412||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.412|-0.241|0.6068
71937903|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.024||||0.8838|TWO_SIDED|95.0|-0.352|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.303|-0.352|0.8838
71937904|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.323||||0.0556|TWO_SIDED|95.0|-0.653|0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.008|-0.653|0.0556
71937905|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.051||||0.7673|TWO_SIDED|95.0|-0.389|0.287||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.287|-0.389|0.7673
71692676|NCT01922258|142900180|SUPERIORITY||Treatment Difference|-2.34|||=|0.1454|TWO_SIDED|95.0|-5.49|0.82|||Mixed-effect model repeated measure|||||0.82|-5.49|=0.1454
71692677|NCT04552132|142900189|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
71692678|NCT04552132|142900190|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71692679|NCT04552132|142900191|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||0.63
71937906|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.05||||0.7709|TWO_SIDED|95.0|-0.389|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.289|-0.389|0.7709
71937907|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.386||||0.0273|TWO_SIDED|95.0|-0.728|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.043|-0.728|0.0273
71937908|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.044||||0.795|TWO_SIDED|95.0|-0.378|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.289|-0.378|0.7950
71937909|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.236||||0.1656|TWO_SIDED|95.0|-0.57|0.098||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.098|-0.570|0.1656
71937910|NCT02637557|143396728|SUPERIORITY||LS Mean Difference|-0.385||||0.0254|TWO_SIDED|95.0|-0.722|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.048|-0.722|0.0254
71692680|NCT04552132|142900192|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71692681|NCT04552132|142900193|SUPERIORITY|||||||0.57|||||||Fisher Exact|||||||0.57
71692682|NCT04552132|142900194|SUPERIORITY|||||||0.6|||||||Fisher Exact|||||||0.60
71692683|NCT04552132|142900195|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71692684|NCT04552132|142900196|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71692685|NCT04552132|142900197|SUPERIORITY|||||||0.18|||||||Chi-squared|||||||0.18
71692686|NCT04552132|142900198|SUPERIORITY|||||||0.4993|||||||Chi-squared|||||||.4993
71692687|NCT04552132|142900199|SUPERIORITY|||||||0.52|||||||t-test, 2 sided|||||||0.52
71692688|NCT04552132|142900200|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|||||||.70
71692689|NCT02256839|142900201|EQUIVALENCE|A 2x2 contingency table with 95% CI.|2 x 2 contingency table|98.1|||||TWO_SIDED|95.0|95.3|99.3||||||||99.3|95.3|
71692690|NCT02256839|142900201|EQUIVALENCE|A 2x2 contingency table with 95% CI|2 x 2 contingency table|96.1|||||TWO_SIDED|95.0|85.4|99.3||||||||99.3|85.4|
71692691|NCT00121719|142900218|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0146|||||||Wilcoxon signed-rank test|||This was a pilot study and a statistical sample size calculation was not performed.||||0.0146
71692692|NCT00382785|142900237|SUPERIORITY_OR_OTHER|||||||0.315|TWO_SIDED|95.0|||||univariate analysis|||Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).||||.315
71692693|NCT00382785|142900238|SUPERIORITY_OR_OTHER|||||||0.23||95.0|||||univariate analysis|Null Hypothesis: There will be no difference between the moderated and peer-led groups based on type of online support (moderated; peer-led)||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).||||.23
71692694|NCT00382785|142900239|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED|95.0|||||Univariate Analysis|||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).||||.32
71692695|NCT01705977|142900250|OTHER||Difference in percentage versus placebo|0.1|||||TWO_SIDED|95.0|-0.31|0.51|||||95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-0.31|
71692696|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|-0.35|||||TWO_SIDED|95.0|-1.55|0.85|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.85|-1.55|
71692697|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|-0.7|||||TWO_SIDED|95.0|-1.6|0.2|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.20|-1.60|
71692698|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|0.0|||||TWO_SIDED|95.0|-0.31|0.31|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.31|
71692699|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
71692700|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
71692701|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|0.26|||||TWO_SIDED|95.0|-0.44|0.96|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.96|-0.44|
71692702|NCT01705977|142900251|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
71692703|NCT01705977|142900253|OTHER||Difference in percentage versus placebo|-0.45|||||TWO_SIDED|95.0|-1.03|0.13|||||95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.13|-1.03|
71692704|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|-0.75|||||TWO_SIDED|95.0|-2.02|0.51|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.51|-2.02|
71692705|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|-1.0|||||TWO_SIDED|95.0|-1.96|-0.04|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.|||-0.04|-1.96|
71692706|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|-0.1|||||TWO_SIDED|95.0|-0.44|0.24|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.24|-0.44|
71692707|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|0.05|||||TWO_SIDED|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.31|-0.21|
71692708|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.58|0.02|
71692709|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|0.31|||||TWO_SIDED|95.0|-0.42|1.05|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.|||1.05|-0.42|
71692710|NCT01705977|142900254|OTHER||Difference in percentage versus placebo|0.3|||||TWO_SIDED|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.|||0.61|-0.01|
71692711|NCT01705977|142900256|OTHER||Odds ratio versus placebo|1.3||||0.0284|TWO_SIDED|95.0|1.03|1.65|||Regression, Logistic||95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (\<=9 versus \>=10) and region|||1.65|1.03|0.0284
71692712|NCT00808067|142900311|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.77||||0.0055|TWO_SIDED|95.0|0.64|0.93|||Regression, Cox|||||0.93|0.64|0.0055
71692713|NCT00808067|142900318|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09||||0.5119|TWO_SIDED|95.0|0.84|1.42|||Regression, Cox|||||1.42|0.84|0.5119
71692714|NCT00808067|142900319|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.1||||0.2371|TWO_SIDED|95.0|0.94|1.29|||Regression, Cox|||||1.29|0.94|0.2371
71692715|NCT00808067|142900320|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.5052|TWO_SIDED|95.0|0.89|1.27|||Regression, Cox|||||1.27|0.89|0.5052
71692716|NCT00808067|142900321|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.2241||95.0|0.82|1.05|||Regression, Cox|||||1.05|0.82|0.2241
71692717|NCT00490971|142900396|SUPERIORITY_OR_OTHER|||||||0.017||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 85.0% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0195.|Weighted Z- test|||Null hypothesis: there is no difference between Pali/Pali and Pali/Placebo in the time to recurrence of any mood symptoms related to bipolar I disorder. An interim analysis was performed when approximately 85% of the required number of recurrences were reported in Pali/Pali and Pali/Placebo treatment groups. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||0.017
71761112|NCT01039376|143023892|SUPERIORITY||Mean Difference (Final Values)|-3.79||||0.0085|TWO_SIDED|95.0|-6.61|-0.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue Scale|||-0.97|-6.61|0.0085
71692718|NCT00490971|142900397|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 81.9% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0198.|Weighted z-test|||At the time of interim analysis of the primary efficacy endpoint, the proportion of recurrence of manic symptoms was 81.9% of the number of recurrence of manic symptoms at final analysis. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.||||<0.001
71692719|NCT00490971|142900398|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.88|||||TWO_SIDED|95.0|0.53|1.46||Cox proportional hazards regression was performed with treatment (Pali/Placebo, Pali/Pali) as a factor. The 2 treatment groups were compared by means of a hazard ratio (Pali/Placebo: Pali/Pali)|Regression, Cox|The percent of participants who reported recurrence of depressive symptoms was: 18% Pali/Placebo, 24% Pali/Pali.|Hazard ratio was estimated with Pali/Placebo in the numerator and Pali/Pali in the denominator|||1.46|0.53|
71692720|NCT00490971|142900399|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|||<|0.001|TWO_SIDED|95.0|-6.92|-1.98|||ANCOVA|ANCOVA model with treatment group (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||-1.98|-6.92|<0.001
71937911|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.093||||0.3788|TWO_SIDED|95.0|-0.114|0.3||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.300|-0.114|0.3788
71937912|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.189||||0.0761|TWO_SIDED|95.0|-0.02|0.397||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.397|-0.020|0.0761
71937913|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.021||||0.8415|TWO_SIDED|95.0|-0.232|0.189||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.189|-0.232|0.8415
71937914|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.052||||0.6719|TWO_SIDED|95.0|-0.19|0.294||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.294|-0.190|0.6719
71937915|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.007||||0.9549|TWO_SIDED|95.0|-0.237|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.237|0.9549
71937916|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.096||||0.4408|TWO_SIDED|95.0|-0.342|0.149||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.149|-0.342|0.4408
71937917|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.004||||0.9736|TWO_SIDED|95.0|-0.262|0.253||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.253|-0.262|0.9736
71937918|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.146||||0.2703|TWO_SIDED|95.0|-0.405|0.114||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.114|-0.405|0.2703
71937919|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.351||||0.0087|TWO_SIDED|95.0|-0.612|-0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.089|-0.612|0.0087
71937920|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.026||||0.848|TWO_SIDED|95.0|-0.295|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.243|-0.295|0.8480
71692721|NCT00490971|142900400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.763|TWO_SIDED|95.0|-1.87|2.55|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||2.55|-1.87|0.763
71937921|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.073||||0.5966|TWO_SIDED|95.0|-0.344|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.344|0.5966
71937922|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.324||||0.0203|TWO_SIDED|95.0|-0.596|-0.051||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.051|-0.596|0.0203
71937923|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.025||||0.854|TWO_SIDED|95.0|-0.294|0.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.244|-0.294|0.8540
71937924|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.022||||0.8757|TWO_SIDED|95.0|-0.293|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.250|-0.293|0.8757
71937925|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.332||||0.0174|TWO_SIDED|95.0|-0.605|-0.059||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.059|-0.605|0.0174
71937926|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.078||||0.5831|TWO_SIDED|95.0|-0.202|0.358||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.358|-0.202|0.5831
71937927|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.078||||0.5859|TWO_SIDED|95.0|-0.36|0.204||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.204|-0.360|0.5859
71937928|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.291||||0.0447|TWO_SIDED|95.0|-0.575|-0.007||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.007|-0.575|0.0447
71937929|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.093||||0.5365|TWO_SIDED|95.0|-0.203|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.388|-0.203|0.5365
71937930|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.057||||0.7067|TWO_SIDED|95.0|-0.355|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.241|-0.355|0.7067
71692722|NCT00490971|142900401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.7||||0.01|TWO_SIDED|95.0|1.4|10.09|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||10.09|1.40|0.010
71937931|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.317||||0.0386|TWO_SIDED|95.0|-0.616|-0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.017|-0.616|0.0386
71937932|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|0.042||||0.7804|TWO_SIDED|95.0|-0.253|0.336||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.336|-0.253|0.7804
71937933|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.125||||0.4064|TWO_SIDED|95.0|-0.422|0.171||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.171|-0.422|0.4064
71937934|NCT02637557|143396729|SUPERIORITY||LS Mean Difference|-0.333||||0.0289|TWO_SIDED|95.0|-0.632|-0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.035|-0.632|0.0289
71937935|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|0.037||||0.7207|TWO_SIDED|95.0|-0.167|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.167|0.7207
71937936|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.071||||0.4946|TWO_SIDED|95.0|-0.275|0.133||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.133|-0.275|0.4946
71937937|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.077||||0.4596|TWO_SIDED|95.0|-0.283|0.129||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.129|-0.283|0.4596
71937938|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|0.067||||0.5987|TWO_SIDED|95.0|-0.182|0.315||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.315|-0.182|0.5987
71937939|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.122||||0.3348|TWO_SIDED|95.0|-0.372|0.127||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.127|-0.372|0.3348
71937940|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.062||||0.6288|TWO_SIDED|95.0|-0.313|0.19||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.190|-0.313|0.6288
71937941|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.048||||0.7193|TWO_SIDED|95.0|-0.312|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.216|-0.312|0.7193
71937942|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.27||||0.0452|TWO_SIDED|95.0|-0.534|-0.006||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.006|-0.534|0.0452
71937943|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.252||||0.0635|TWO_SIDED|95.0|-0.519|0.014||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.014|-0.519|0.0635
71937944|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.126||||0.38|TWO_SIDED|95.0|-0.409|0.156||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.156|-0.409|0.3800
71937945|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.336||||0.02|TWO_SIDED|95.0|-0.62|-0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.053|-0.620|0.0200
71937946|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.328||||0.0244|TWO_SIDED|95.0|-0.614|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.043|-0.614|0.0244
71937947|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.096||||0.5232|TWO_SIDED|95.0|-0.392|0.2||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.200|-0.392|0.5232
71937948|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.282||||0.0623|TWO_SIDED|95.0|-0.579|0.015||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.015|-0.579|0.0623
71937949|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.255||||0.0951|TWO_SIDED|95.0|-0.554|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.045|-0.554|0.0951
71937950|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.06||||0.6985|TWO_SIDED|95.0|-0.363|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.243|-0.363|0.6985
71937951|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.373||||0.0163|TWO_SIDED|95.0|-0.677|-0.069||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.069|-0.677|0.0163
71937952|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.345||||0.0273|TWO_SIDED|95.0|-0.652|-0.039||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.039|-0.652|0.0273
71937953|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.056||||0.7187|TWO_SIDED|95.0|-0.362|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.250|-0.362|0.7187
71937954|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.29||||0.064|TWO_SIDED|95.0|-0.596|0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.017|-0.596|0.0640
71937955|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.484||||0.0023|TWO_SIDED|95.0|-0.793|-0.175||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.175|-0.793|0.0023
71937956|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.079||||0.6033|TWO_SIDED|95.0|-0.378|0.22||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.220|-0.378|0.6033
71937957|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.35||||0.0222|TWO_SIDED|95.0|-0.65|-0.05||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.050|-0.650|0.0222
71937958|NCT02637557|143396730|SUPERIORITY||LS Mean Difference|-0.482||||0.0019|TWO_SIDED|95.0|-0.785|-0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.180|-0.785|0.0019
71937959|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|0.143||||0.1922|TWO_SIDED|95.0|-0.072|0.357||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.357|-0.072|0.1922
71937960|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|0.072||||0.5091|TWO_SIDED|95.0|-0.143|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.288|-0.143|0.5091
71937961|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|0.037||||0.7394|TWO_SIDED|95.0|-0.181|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.254|-0.181|0.7394
71937962|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|0.073||||0.5845|TWO_SIDED|95.0|-0.189|0.334||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.334|-0.189|0.5845
71937963|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.034||||0.7959|TWO_SIDED|95.0|-0.296|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.228|-0.296|0.7959
71692723|NCT00490971|142900402|SUPERIORITY_OR_OTHER|||||||0.007||95.0|||||ANCOVA|ANCOVA Model on ranks with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)||||0.007
71937964|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.015||||0.9086|TWO_SIDED|95.0|-0.28|0.249||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.249|-0.280|0.9086
71937965|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.08||||0.5334|TWO_SIDED|95.0|-0.333|0.173||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.173|-0.333|0.5334
71937966|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.212||||0.102|TWO_SIDED|95.0|-0.466|0.042||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.042|-0.466|0.1020
71937967|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.357||||0.0066|TWO_SIDED|95.0|-0.613|-0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.100|-0.613|0.0066
71937968|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.127||||0.3586|TWO_SIDED|95.0|-0.399|0.145||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.145|-0.399|0.3586
71692724|NCT03430856|142900460|NON_INFERIORITY|Change from baseline in HbA1c at 24 weeks of treatment, was analyzed using mixed model for repeated measures (MMRM) where all available post-baseline HbA1c measurements obtained up to Week 24 was entered as the dependent variables; visit and treatment were included as fixed factors, with Baseline HbA1c and stratification factor variables as covariates. Furthermore, the interaction terms of visit by treatment, visit by stratification factors and visit by Baseline HbA1c were included in the model.|Mean Difference (Net)|0.99|||||TWO_SIDED|95.0|0.502|1.47|||||Insulin Tregopil 45 mg - Insulin Aspart|||1.470|0.502|
71937969|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.348||||0.0128|TWO_SIDED|95.0|-0.621|-0.075||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.075|-0.621|0.0128
71937970|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.384||||0.0064|TWO_SIDED|95.0|-0.66|-0.109||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.109|-0.660|0.0064
71692725|NCT03430856|142900460|NON_INFERIORITY|Non inferiority margin is 0.4%|Mean Difference (Net)|0.89|||||TWO_SIDED|95.0|0.414|1.37|||||Insulin Tregopil 30mg - Insulin Aspart|||1.370|0.414|
71937971|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.076||||0.6124|TWO_SIDED|95.0|-0.369|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.218|-0.369|0.6124
71692726|NCT02002871|142900479|SUPERIORITY_OR_OTHER|||||||0.0152|TWO_SIDED||||||t-test, 2 sided|||The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.||||0.0152
71692727|NCT02359110|142900501|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.89|TWO_SIDED|95.0|-1.2|1.3|||Mixed Models Analysis|||Hour 2 Analysis||1.3|-1.2|0.89
71692728|NCT02359110|142900501|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.94|TWO_SIDED|95.0|-1.6|1.5|||Mixed Models Analysis|||Hour 4 Analysis||1.5|-1.6|0.94
71692729|NCT02359110|142900501|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.64|TWO_SIDED|95.0|-2.2|1.3|||Mixed Models Analysis|||Hour 6 Analysis||1.3|-2.2|0.64
71692730|NCT02359110|142900501|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.59|TWO_SIDED|95.0|-1.6|2.8|||Mixed Models Analysis|||Hour 8 Analysis||2.8|-1.6|0.59
71692731|NCT02359110|142900502|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.52|TWO_SIDED|95.0|-8.1|15.8|||Mixed Models Analysis|||Hour 2 Analysis||15.8|-8.1|0.52
71692732|NCT02359110|142900502|SUPERIORITY||Mean Difference (Final Values)|1.7||||0.8|TWO_SIDED|95.0|-11.9|15.3|||Mixed Models Analysis|||Hour 6 Analysis||15.3|-11.9|0.80
71937972|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.223||||0.1365|TWO_SIDED|95.0|-0.518|0.071||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.071|-0.518|0.1365
71937973|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.355||||0.0193|TWO_SIDED|95.0|-0.652|-0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.058|-0.652|0.0193
71937974|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.037||||0.8046|TWO_SIDED|95.0|-0.333|0.258||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.258|-0.333|0.8046
71937975|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.319||||0.035|TWO_SIDED|95.0|-0.616|-0.023||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.023|-0.616|0.0350
71937976|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.392||||0.0105|TWO_SIDED|95.0|-0.691|-0.093||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.093|-0.691|0.0105
71937977|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.094||||0.5482|TWO_SIDED|95.0|-0.403|0.214||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.214|-0.403|0.5482
71937978|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.377||||0.017|TWO_SIDED|95.0|-0.687|-0.068||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.068|-0.687|0.0170
71937979|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.469||||0.0034|TWO_SIDED|95.0|-0.781|-0.157||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.157|-0.781|0.0034
71937980|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.093||||0.5346|TWO_SIDED|95.0|-0.388|0.202||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.202|-0.388|0.5346
71937981|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.336||||0.0262|TWO_SIDED|95.0|-0.632|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.040|-0.632|0.0262
71937982|NCT02637557|143396731|SUPERIORITY||LS Mean Difference|-0.545||||0.0004|TWO_SIDED|95.0|-0.843|-0.246||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.246|-0.843|0.0004
71937983|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|0.098||||0.3007|TWO_SIDED|95.0|-0.088|0.284||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.284|-0.088|0.3007
71937984|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|0.143||||0.1295|TWO_SIDED|95.0|-0.042|0.328||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.328|-0.042|0.1295
71937985|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.028||||0.7671|TWO_SIDED|95.0|-0.216|0.159||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.159|-0.216|0.7671
71937986|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|0.01||||0.9308|TWO_SIDED|95.0|-0.217|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.238|-0.217|0.9308
71692733|NCT02359110|142900503|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.88
71692734|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5221||||||The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5221
71692735|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.25||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.|Wilcoxon test|||||||0.25
71692736|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.|Wilcoxon test|||||||0.50
71692737|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.|Wilcoxon test|||||||0.16
71692738|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8665||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8665
71692739|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.88
71937987|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|0.051||||0.6595|TWO_SIDED|95.0|-0.176|0.277||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.277|-0.176|0.6595
71937988|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.127||||0.2771|TWO_SIDED|95.0|-0.356|0.102||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.102|-0.356|0.2771
71937989|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.203||||0.0887|TWO_SIDED|95.0|-0.436|0.031||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.031|-0.436|0.0887
71937990|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.21||||0.0758|TWO_SIDED|95.0|-0.443|0.022||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.022|-0.443|0.0758
71937991|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.298||||0.0132|TWO_SIDED|95.0|-0.534|-0.063||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.063|-0.534|0.0132
71937992|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.086||||0.4903|TWO_SIDED|95.0|-0.332|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.160|-0.332|0.4903
71937993|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.068||||0.5824|TWO_SIDED|95.0|-0.313|0.176||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.176|-0.313|0.5824
71937994|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.215||||0.0885|TWO_SIDED|95.0|-0.463|0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.033|-0.463|0.0885
71937995|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.111||||0.3652|TWO_SIDED|95.0|-0.352|0.13||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.130|-0.352|0.3652
71937996|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.108||||0.3739|TWO_SIDED|95.0|-0.348|0.131||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.131|-0.348|0.3739
71692740|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.84||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.|Wilcoxon test|||||||0.84
71937997|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.27||||0.0294|TWO_SIDED|95.0|-0.512|-0.027||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.027|-0.512|0.0294
71937998|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.102||||0.4236|TWO_SIDED|95.0|-0.351|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.351|0.4236
71937999|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.105||||0.4071|TWO_SIDED|95.0|-0.353|0.144||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.144|-0.353|0.4071
71938000|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.259||||0.0434|TWO_SIDED|95.0|-0.51|-0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.008|-0.510|0.0434
71938001|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.103||||0.4172|TWO_SIDED|95.0|-0.354|0.147||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.147|-0.354|0.4172
71938002|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.071||||0.5759|TWO_SIDED|95.0|-0.321|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.321|0.5759
71938003|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.285||||0.0271|TWO_SIDED|95.0|-0.538|-0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.033|-0.538|0.0271
71938004|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.14||||0.2804|TWO_SIDED|95.0|-0.395|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.115|-0.395|0.2804
71938005|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.218||||0.0913|TWO_SIDED|95.0|-0.472|0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.035|-0.472|0.0913
71938006|NCT02637557|143396732|SUPERIORITY||LS Mean Difference|-0.38||||0.0039|TWO_SIDED|95.0|-0.637|-0.123||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.123|-0.637|0.0039
71938007|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|0.128||||0.1902|TWO_SIDED|95.0|-0.064|0.319||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.319|-0.064|0.1902
71692741|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.57||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.|Wilcoxon test|||||||0.57
71938008|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|0.1||||0.3021|TWO_SIDED|95.0|-0.091|0.292||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.292|-0.091|0.3021
71938009|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.028||||0.775|TWO_SIDED|95.0|-0.221|0.165||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.165|-0.221|0.7750
71938010|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|0.099||||0.4022|TWO_SIDED|95.0|-0.133|0.33||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.330|-0.133|0.4022
71938011|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|0.062||||0.5971|TWO_SIDED|95.0|-0.169|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.293|-0.169|0.5971
71938012|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.045||||0.7024|TWO_SIDED|95.0|-0.279|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.188|-0.279|0.7024
71938013|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.115||||0.3173|TWO_SIDED|95.0|-0.342|0.111||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.111|-0.342|0.3173
71692742|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3052||||||The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3052
71938014|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.151||||0.1906|TWO_SIDED|95.0|-0.378|0.076||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.076|-0.378|0.1906
71938015|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.183||||0.1177|TWO_SIDED|95.0|-0.412|0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.046|-0.412|0.1177
71938016|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.05||||0.6936|TWO_SIDED|95.0|-0.297|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.198|-0.297|0.6936
71938017|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.096||||0.4466|TWO_SIDED|95.0|-0.343|0.152||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.152|-0.343|0.4466
71938018|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.155||||0.2225|TWO_SIDED|95.0|-0.405|0.095||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.095|-0.405|0.2225
71938019|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.052||||0.6764|TWO_SIDED|95.0|-0.297|0.193||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.193|-0.297|0.6764
71938020|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.061||||0.6243|TWO_SIDED|95.0|-0.306|0.184||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.184|-0.306|0.6243
71692743|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of B cells at dose level 1.|Wilcoxon test|The reported p-value is representative of the changes in levels of B cells at dose level 1.||||||>0.9999
71938021|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.156||||0.2151|TWO_SIDED|95.0|-0.403|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.091|-0.403|0.2151
71938022|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.096||||0.4611|TWO_SIDED|95.0|-0.351|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.160|-0.351|0.4611
71938023|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.139||||0.2849|TWO_SIDED|95.0|-0.394|0.116||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.116|-0.394|0.2849
71938024|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.228||||0.0833|TWO_SIDED|95.0|-0.485|0.03||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.030|-0.485|0.0833
71938025|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.017||||0.8955|TWO_SIDED|95.0|-0.277|0.242||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.242|-0.277|0.8955
71938026|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.052||||0.6916|TWO_SIDED|95.0|-0.312|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.207|-0.312|0.6916
71938027|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.159||||0.2345|TWO_SIDED|95.0|-0.421|0.103||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.103|-0.421|0.2345
71938028|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.043||||0.7466|TWO_SIDED|95.0|-0.304|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.218|-0.304|0.7466
71938029|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.176||||0.1843|TWO_SIDED|95.0|-0.437|0.084||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.084|-0.437|0.1843
71938030|NCT02637557|143396733|SUPERIORITY||LS Mean Difference|-0.267||||0.0471|TWO_SIDED|95.0|-0.531|-0.003||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.003|-0.531|0.0471
71938031|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|0.088||||0.3258|TWO_SIDED|95.0|-0.088|0.265||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.265|-0.088|0.3258
71938032|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|0.084||||0.3483|TWO_SIDED|95.0|-0.092|0.261||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.261|-0.092|0.3483
71938033|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|0.022||||0.8055|TWO_SIDED|95.0|-0.156|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.201|-0.156|0.8055
71938034|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|0.103||||0.3627|TWO_SIDED|95.0|-0.119|0.326||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.326|-0.119|0.3627
71692744|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of B cells at dose level 3.|Wilcoxon test|||||||0.13
71692745|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of B cells at dose level 4.|Wilcoxon test|||||||0.65
71938035|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|0.087||||0.4404|TWO_SIDED|95.0|-0.135|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.310|-0.135|0.4404
71938036|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|0.001||||0.9939|TWO_SIDED|95.0|-0.224|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.226|-0.224|0.9939
71938037|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.128||||0.2716|TWO_SIDED|95.0|-0.356|0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.100|-0.356|0.2716
71938038|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.116||||0.3175|TWO_SIDED|95.0|-0.345|0.112||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.112|-0.345|0.3175
71938039|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.252||||0.0325|TWO_SIDED|95.0|-0.483|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||-0.021|-0.483|0.0325
71938040|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.169||||0.1769|TWO_SIDED|95.0|-0.415|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.077|-0.415|0.1769
71938041|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.188||||0.1343|TWO_SIDED|95.0|-0.434|0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.058|-0.434|0.1343
71938042|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.295||||0.0203|TWO_SIDED|95.0|-0.544|-0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||-0.046|-0.544|0.0203
71938043|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.152||||0.2543|TWO_SIDED|95.0|-0.415|0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.110|-0.415|0.2543
71938044|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.142||||0.2892|TWO_SIDED|95.0|-0.405|0.121||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.121|-0.405|0.2892
71938045|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.306||||0.0243|TWO_SIDED|95.0|-0.571|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||-0.040|-0.571|0.0243
71938046|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.059||||0.6471|TWO_SIDED|95.0|-0.312|0.194||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.194|-0.312|0.6471
71938047|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.106||||0.4123|TWO_SIDED|95.0|-0.359|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.148|-0.359|0.4123
71938048|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.278||||0.0338|TWO_SIDED|95.0|-0.534|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||-0.021|-0.534|0.0338
71938049|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.095||||0.4841|TWO_SIDED|95.0|-0.362|0.172||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.172|-0.362|0.4841
71938050|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.152||||0.2627|TWO_SIDED|95.0|-0.419|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.115|-0.419|0.2627
71938051|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.311||||0.0241|TWO_SIDED|95.0|-0.581|-0.041||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||-0.041|-0.581|0.0241
71938052|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.093||||0.4881|TWO_SIDED|95.0|-0.355|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.355|0.4881
71938053|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.164||||0.2205|TWO_SIDED|95.0|-0.427|0.099||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.099|-0.427|0.2205
71938054|NCT02637557|143396734|SUPERIORITY||LS Mean Difference|-0.433||||0.0015|TWO_SIDED|95.0|-0.699|-0.168||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||-0.168|-0.699|0.0015
71938055|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.043||||0.6653|TWO_SIDED|95.0|-0.152|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.238|-0.152|0.6653
71938056|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.15||||0.1327|TWO_SIDED|95.0|-0.046|0.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.345|-0.046|0.1327
71938057|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.043||||0.6697|TWO_SIDED|95.0|-0.155|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1||0.241|-0.155|0.6697
71938058|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.021||||0.8598|TWO_SIDED|95.0|-0.21|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.251|-0.210|0.8598
71938059|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.113||||0.3354|TWO_SIDED|95.0|-0.118|0.344||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.344|-0.118|0.3354
71938060|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.055||||0.6429|TWO_SIDED|95.0|-0.179|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2||0.289|-0.179|0.6429
71938061|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.101||||0.401|TWO_SIDED|95.0|-0.336|0.135||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.135|-0.336|0.4010
71938062|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.129||||0.2821|TWO_SIDED|95.0|-0.364|0.106||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.106|-0.364|0.2821
71692746|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0698||||||The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0698
71692747|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NK cells at dose level 1.|Wilcoxon test|||||||0.63
71938063|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.149||||0.2189|TWO_SIDED|95.0|-0.388|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3||0.089|-0.388|0.2189
71938064|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.093||||0.4717|TWO_SIDED|95.0|-0.346|0.161||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.161|-0.346|0.4717
71938065|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.096||||0.4572|TWO_SIDED|95.0|-0.349|0.158||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.158|-0.349|0.4572
71938066|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.165||||0.2064|TWO_SIDED|95.0|-0.422|0.092||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4||0.092|-0.422|0.2064
71938067|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.088||||0.4932|TWO_SIDED|95.0|-0.339|0.164||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.164|-0.339|0.4932
71938068|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.069||||0.5897|TWO_SIDED|95.0|-0.321|0.183||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.183|-0.321|0.5897
71692748|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of NK cells at dose level 3.|Wilcoxon test|||||||0.74
71938069|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.166||||0.2014|TWO_SIDED|95.0|-0.421|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5||0.089|-0.421|0.2014
71938070|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.044||||0.7384|TWO_SIDED|95.0|-0.304|0.215||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.215|-0.304|0.7384
71692749|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of NK cells at dose level 4.|Wilcoxon test|||||||0.13
71692750|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0127||||||The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0127
71692751|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 1.|Wilcoxon test|||||||0.63
71692752|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.41||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 3.|Wilcoxon test|||||||0.41
71692753|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.07||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 4.|Wilcoxon test|||||||0.07
71692754|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0654||||||The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0654
71938071|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.043||||0.7423|TWO_SIDED|95.0|-0.303|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.216|-0.303|0.7423
71938072|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.141||||0.2923|TWO_SIDED|95.0|-0.404|0.122||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6||0.122|-0.404|0.2923
71938073|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.085||||0.5388|TWO_SIDED|95.0|-0.359|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.188|-0.359|0.5388
71938074|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|0.008||||0.9565|TWO_SIDED|95.0|-0.266|0.281||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.281|-0.266|0.9565
71938075|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.099||||0.4848|TWO_SIDED|95.0|-0.376|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7||0.179|-0.376|0.4848
71938076|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.164||||0.2523|TWO_SIDED|95.0|-0.445|0.117||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.117|-0.445|0.2523
71938077|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.112||||0.4356|TWO_SIDED|95.0|-0.393|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.170|-0.393|0.4356
71938078|NCT02637557|143396735|SUPERIORITY||LS Mean Difference|-0.199||||0.1706|TWO_SIDED|95.0|-0.485|0.086||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8||0.086|-0.485|0.1706
71938079|NCT02637557|143396736|SUPERIORITY||LS Mean Difference|-0.02||||0.7689|TWO_SIDED|95.0|-0.155|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.115|-0.155|0.7689
71938080|NCT02637557|143396736|SUPERIORITY||LS Mean Difference|0.034||||0.6287|TWO_SIDED|95.0|-0.103|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.170|-0.103|0.6287
71938081|NCT02637557|143396736|SUPERIORITY||LS Mean Difference|0.07||||0.3106|TWO_SIDED|95.0|-0.066|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.207|-0.066|0.3106
71938082|NCT02637557|143396737|SUPERIORITY||LS Mean Difference|0.0||||0.9961|TWO_SIDED|95.0|-0.1|0.101||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.101|-0.100|0.9961
71938083|NCT02637557|143396737|SUPERIORITY||LS Mean Difference|-0.008||||0.8829|TWO_SIDED|95.0|-0.109|0.094||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.094|-0.109|0.8829
71938084|NCT02637557|143396737|SUPERIORITY||LS Mean Difference|0.1||||0.0527|TWO_SIDED|95.0|-0.001|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||||0.201|-0.001|0.0527
71938085|NCT04604184|143396761|OTHER||Risk Difference (RD)|-5.39||||0.3232|TWO_SIDED|95.0|-16.08|5.3|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||5.30|-16.08|0.3232
71938086|NCT04604184|143396762|OTHER||Risk Difference (RD)|-9.86||||0.1274|TWO_SIDED|95.0|-22.54|2.82|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||2.82|-22.54|0.1274
71938087|NCT04604184|143396763|OTHER||Risk Difference (RD)|2.66||||0.6828|TWO_SIDED|95.0|-10.11|15.43|||Regression, Logistic|includes treatment, age, severity grade and creatinine at baseline, duration of symptoms before hospitalisation as covariates||||15.43|-10.11|0.6828
71938088|NCT04604184|143396764|OTHER||Rate Ratio|0.67||||0.0445|TWO_SIDED|95.0|0.46|0.99|||Regression, Cox|Covariates are treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalization||||0.99|0.46|0.0445
71938089|NCT04604184|143396765|OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.35||0.5526|TWO_SIDED|95.0|-3.47|1.87|||ANCOVA|Fixed effects of treatment, age, severity grade and creatinine at baseline and duration of symptoms before hospitalisation as covariates|Difference = covariate adjusted BI 764198 - covariate adjusted Placebo|||1.87|-3.47|0.5526
71938090|NCT04604184|143396766|OTHER||Risk Difference (RD)|5.32||||0.0995|TWO_SIDED|95.0|-1.01|11.65|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 15||11.65|-1.01|0.0995
71938091|NCT04604184|143396766|OTHER||Risk Difference (RD)|6.06||||0.1992|TWO_SIDED|95.0|-3.19|15.31|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 29||15.31|-3.19|0.1992
71938092|NCT04604184|143396766|OTHER||Risk Difference (RD)|8.93||||0.0709|TWO_SIDED|95.0|-0.76|18.62|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 60||18.62|-0.76|0.0709
71938093|NCT04604184|143396766|OTHER||Risk Difference (RD)|10.35||||0.0412|TWO_SIDED|95.0|0.41|20.28|||Regression, Logistic|Includes treatment, age, severity grade and creatinine at baseline, and duration of symptoms before hospitalisation as covariates||Day 90||20.28|0.41|0.0412
71938094|NCT01711021|143396774|SUPERIORITY||Least Square (LS) mean difference|-5.87|||<|0.001|TWO_SIDED|95.0|-6.76|-4.97|||Mixed Models Analysis|Mixed model repeated measure (MMRM) analysis for SKAMP total score in Double-Blind period||||-4.97|-6.76|< 0.001
71938095|NCT01711021|143396776|SUPERIORITY|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71938096|NCT01844583|143396781|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.14|||||TWO_SIDED|90.0|0.97|1.35|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.35|0.97|
71938097|NCT01844583|143396782|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.25|||||TWO_SIDED|90.0|1.08|1.45|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.45|1.08|
71938098|NCT01844583|143396783|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.28|||||TWO_SIDED|90.0|1.07|1.53|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.53|1.07|
71938099|NCT01844583|143396786|SUPERIORITY_OR_OTHER||LS Mean Ratio|1.03|||||TWO_SIDED|90.0|0.84|1.26|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||1.26|0.84|
71692755|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 1.|Wilcoxon test|||||||0.38
71692756|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.21||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 3.|Wilcoxon test|||||||0.21
71938100|NCT01844583|143396787|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.51|||||TWO_SIDED|90.0|0.41|0.62|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.62|0.41|
71938101|NCT01844583|143396788|SUPERIORITY_OR_OTHER||LS Mean Ratio|0.53|||||TWO_SIDED|90.0|0.41|0.7|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.|||0.70|0.41|
71938102|NCT01625377|143396794|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.34|||<|0.0001|TWO_SIDED|95.0|-21.34|-7.34|||ANCOVA|||||-7.34|-21.34|<0.0001
71938103|NCT03513497|143396807|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71938104|NCT03513497|143396808|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71938105|NCT03513497|143396809|SUPERIORITY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.6
71938106|NCT03513497|143396810|SUPERIORITY|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||||||0.5
71938107|NCT01412541|143396813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.||||||0.025|||||||Farrington and Manning|||"To assess if proportion of subjects with at least one safety event\* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group."||||0.025
71938108|NCT01412541|143396814|EQUIVALENCE|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test at α=0.05. The response variable in each subject will be the presence or absence of at least one efficacy event from the time following the index procedure through 12 months. The study evaluable sample size required for 90% power is approximately 405 subjects. After adjustment for 15% censoring through 12 months, the study size is 476.||||||0.05|||||||Chi-squared|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test.||"To assess whether the proportion of subjects with at least one efficacy event\* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group."||||0.05
71938109|NCT03294538|143396831|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|0.7|||||TWO_SIDED|90.0|-5.8|7.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the primary endpoint was evaluated in the PP population.||7.2|-5.8|
71938110|NCT03294538|143396832|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|19.9|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
71938111|NCT03294538|143396832|SUPERIORITY|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|20.2|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||<0.0001
71938112|NCT03294538|143396833|EQUIVALENCE|If the adjusted 90% confidence interval on the difference between proportions of participants considered Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range \[-0.20, +0.20\], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|-1.4|||||TWO_SIDED|90.0|-9.0|6.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the secondary endpoint was evaluated in the PP population.||6.2|-9.0|
71938113|NCT03294538|143396834|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|4.9||||0.2897|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the secondary endpoint was evaluated in the mITT population.||||0.2897
71938114|NCT03294538|143396834|SUPERIORITY|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|3.9||||0.4949|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.||||0.4949
71938115|NCT02833415|143396845|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.9398|STANDARD_ERROR_OF_MEAN|0.2941||0.0053|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.0053
71938116|NCT02833415|143396845|OTHER|Differences of Least Squares Means|Differences of Least Squares Means|0.152|STANDARD_ERROR_OF_MEAN|0.2424||0.5394|TWO_SIDED||||||Mixed Models Analysis|||Baseline to Followup||||0.5394
71938117|NCT01769378|143396846|SUPERIORITY_OR_OTHER||LS Squares Mean Difference|-1.27|STANDARD_ERROR_OF_MEAN|0.15|<|0.001|TWO_SIDED|95.0|-1.57|-0.97|||Mixed Models Analysis|||||-0.97|-1.57|<0.001
71938118|NCT01769378|143396847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.37|||<|0.001|TWO_SIDED|95.0|3.82|33.84|||Regression, Logistic|Sequential gatekeeping strategy was used to adjust for multiplicity.||\<7.0% HbA1c||33.84|3.82|<0.001
71938119|NCT01769378|143396847|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|11.45|||<|0.001|TWO_SIDED|95.0|3.71|35.34|||Regression, Logistic|||≤6.5% HbA1c||35.34|3.71|<0.001
71938120|NCT01769378|143396848|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-33.54|STANDARD_ERROR_OF_MEAN|6.6|<|0.001|TWO_SIDED|95.0|-46.55|-20.53|||ANCOVA|Sequential gatekeeping strategy was used to adjust for multiplicity.||||-20.53|-46.55|<0.001
71938121|NCT01769378|143396849|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.68|STANDARD_ERROR_OF_MEAN|0.43||0.12|TWO_SIDED|95.0|-1.53|0.18|||Mixed Models Analysis|Sequential gatekeeping strategy was used to adjust for multiplicity.||||0.18|-1.53|0.120
71938122|NCT01769378|143396850|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.16||0.161|TWO_SIDED|95.0|-0.54|0.09||No adjustment for multiplicity|Mixed Models Analysis|||||0.09|-0.54|0.161
71938123|NCT01769378|143396851|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-28.95|STANDARD_ERROR_OF_MEAN|4.85|<|0.001|TWO_SIDED|95.0|-38.49|-19.4|||Mixed Models Analysis|||||-19.40|-38.49|<0.001
71938124|NCT02324972|143396862|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.636|TWO_SIDED|95.0|-1.3|1.25|||ANCOVA|||A sample size of 20 subjects per group was assumed to have 80% power to allow detection of a statistically significant difference in change from baseline in TLSS between the 2 groups, if the effect size was approximately less than or equal to 0.9. This is equivalent to detecting a difference of -4.5 between the 2 groups with a common standard deviation of 5. The primary analysis was doing using last observation carried forward (LOCF) imputed data.||1.25|-1.30|0.636
71938125|NCT02324972|143396863|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.677|TWO_SIDED|95.0|-0.44|0.68|||ANOVA|||||0.68|-0.44|0.677
71938126|NCT02324972|143396864|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.219||||0.802|TWO_SIDED|95.0|-1.983|1.544|||ANOVA|||||1.544|-1.983|0.802
71938127|NCT02324972|143396865|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.108||||0.976|TWO_SIDED|95.0|-7.076|7.292|||ANOVA|||||7.292|-7.076|0.976
71938128|NCT02324972|143396866|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.52||||0.233|TWO_SIDED|95.0|-1.68|6.72|||ANOVA|||||6.72|-1.68|0.233
71938129|NCT00220701|143396958|SUPERIORITY_OR_OTHER||F statistics|2.82||||0.1|TWO_SIDED||||||Repeated Measures ANOVA|||||||0.10
71938130|NCT00755326|143396964|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.05
71938131|NCT01325207|143396987|OTHER||||||||||||||||||The Maximum Tolerated Dose (MTD) was determined to be 80mg IT every two weeks. This is based on no DLTs being seeing in Cohorts 1-4 with lower doses and 1 DLT out of 7 patients observed at 80mg IT in Cohort 5.|||
71938132|NCT00745251|143397036|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.86|STANDARD_ERROR_OF_MEAN|5.95||0.0084|ONE_SIDED|95.0||-4.84|||ANCOVA|||||-4.84||0.0084
71938133|NCT00745251|143397037|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.05|STANDARD_ERROR_OF_MEAN|1.64||0.0006|TWO_SIDED|95.0|-9.37|-2.74|||ANCOVA|||||-2.74|-9.37|0.0006
71938134|NCT01618305|143397039|SUPERIORITY|P-value was calculated using a Cochran-Mantel-Haenszel test, stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.001|||||||Cochran-Mantel-Haenszel|||||||0.001
71938135|NCT01618305|143397040|SUPERIORITY|||||||0.557|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks)||||||0.557
71938136|NCT01618305|143397041|SUPERIORITY|||||||0.909|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.909
71938137|NCT01618305|143397042|SUPERIORITY|||||||0.938|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by maternal gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||0.938
71938138|NCT01618305|143397043|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
71938139|NCT01618305|143397044|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-\<28 weeks; 28-\<31 weeks; 31-\<34 weeks; 34-\<37 weeks).||||||<0.001
71938140|NCT01618305|143397049|SUPERIORITY|||||||0.623|||||||Fisher Exact|||||||0.623
71938141|NCT01618305|143397050|SUPERIORITY|||||||0.63|||||||Fisher Exact|||||||.63
71938142|NCT01618305|143397051|SUPERIORITY|||||||0.54|||||||Fisher Exact|||||||.54
71938143|NCT01618305|143397052|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71938144|NCT01618305|143397053|SUPERIORITY||||||>|0.99|||||||Fisher Exact|||||||>0.99
71938145|NCT01618305|143397054|SUPERIORITY|||||||0.064|||||||Fisher Exact|||The proportion of HIV-infected infants among those who had a determinable HIV-infection status was compared between arms.||||0.064
71692757|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.16||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 4.|Wilcoxon test|||||||0.16
71938146|NCT02708277|143397057|SUPERIORITY_OR_OTHER|||||||0.009|||||||Chi-squared|||||||0.009
71938147|NCT02708277|143397058|SUPERIORITY_OR_OTHER|||||||0.303|||||||Chi-squared|||||||0.303
71938148|NCT02708277|143397059|SUPERIORITY_OR_OTHER|||||||0.606|||||||t-test, 2 sided|||||||0.606
71938149|NCT02708277|143397060|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||||||0.05
71938150|NCT05188521|143397096|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71938151|NCT05188521|143397097|SUPERIORITY|||||||0.593|||||||Wilcoxon (Mann-Whitney)|||||||0.593
71938152|NCT05188521|143397098|SUPERIORITY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71938153|NCT05188521|143397099|SUPERIORITY|||||||0.138|||||||Wilcoxon (Mann-Whitney)|||||||0.138
71938154|NCT05188521|143397100|SUPERIORITY|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71938155|NCT05188521|143397101|SUPERIORITY|||||||0.357|||||||Wilcoxon (Mann-Whitney)|||||||0.357
71938156|NCT05188521|143397102|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71938157|NCT05188521|143397103|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.000
71692758|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0457||||||The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0457
71692759|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 1.|Wilcoxon test|||||||0.63
71938158|NCT01341639|143397106|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|11.37|||<|0.001|TWO_SIDED|95.0|8.44|14.68||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRP|PR5I minus INFANRIX™ hexa|14.68|8.44|< 0.001
71938159|NCT01341639|143397106|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.95|0.96||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Diphtheria|PR5I minus INFANRIX™ hexa|0.96|-0.95|< 0.001
71938160|NCT01341639|143397106|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.71|0.74|||Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Tetanus|PR5I minus INFANRIX™ hexa|0.74|-0.71|< 0.001
71938161|NCT01341639|143397106|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.51|1.07||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV1|PR5I minus INFANRIX™ hexa|1.07|-0.51|< 0.001
71938162|NCT01341639|143397106|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|TWO_SIDED|95.0|-0.69|1.21||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV2|PR5I minus INFANRIX™ hexa|1.21|-0.69|< 0.001
71938163|NCT01341639|143397106|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|TWO_SIDED|95.0|-0.7|0.73||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV3|PR5I minus INFANRIX™ hexa|0.73|-0.7|< 0.001
71938164|NCT01341639|143397107|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.58|||<|0.001|TWO_SIDED|95.0|-0.49|1.85||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for HBsAg|PR5I minus INFANRIX™ hexa|1.85|-0.49|< 0.001
71692760|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.55||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 3.|Wilcoxon test|||||||0.55
71938165|NCT01341639|143397107|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|1.33|||<|0.001|TWO_SIDED|95.0|0.32|2.86||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PT|PR5I minus INFANRIX™ hexa|2.86|0.32|< 0.001
71938166|NCT01341639|143397107|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-2.59|||<|0.001|TWO_SIDED|95.0|-4.39|-1.29||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for FHA|PR5I minus INFANRIX™ hexa|-1.29|-4.39|< 0.001
71938167|NCT01341639|143397107|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.03|||<|0.001|TWO_SIDED|95.0|-1.4|1.52||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRN|PR5I minus INFANRIX™ hexa|1.52|-1.4|< 0.001
71938168|NCT01341639|143397109|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.26|||<|0.001|TWO_SIDED|95.0|-2.82|2.25||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Measles|PR5I minus INFANRIX™ hexa|2.25|-2.82|< 0.001
71938169|NCT01341639|143397109|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|3.07|||<|0.001|TWO_SIDED|95.0|-0.12|6.4||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Mumps|PR5I minus INFANRIX™ hexa|6.4|-0.12|< 0.001
71938170|NCT01341639|143397109|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.39|||<|0.001|TWO_SIDED|95.0|-1.5|2.34||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Rubella|PR5I minus INFANRIX™ hexa|2.34|-1.5|< 0.001
71938171|NCT01341639|143397109|NON_INFERIORITY|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.02|||<|0.001|TWO_SIDED|95.0|-2.11|2.06||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Varicella|PR5I minus INFANRIX™ hexa|2.06|-2.11|< 0.001
71938172|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-1.9|0.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or systemic AEs|PR5I minus INFANRIX™ hexa|0.4|-1.9|
71938173|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.3|||||TWO_SIDED|95.0|-1.8|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or vaccine-related systemic AEs|PR5I minus INFANRIX™ hexa|1.1|-1.8|
71938174|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1|||||TWO_SIDED|95.0|-2.1|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 ISR|PR5I minus INFANRIX™ hexa|4.3|-2.1|
71938175|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.9|||||TWO_SIDED|95.0|-2.4|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited ISR|PR5I minus INFANRIX™ hexa|4.3|-2.4|
71938176|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.0|||||TWO_SIDED|95.0|-2.4|0.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 systemic AE|PR5I minus INFANRIX™ hexa|0.3|-2.4|
71938177|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.9|||||TWO_SIDED|95.0|-3.2|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related systemic AE|PR5I minus INFANRIX™ hexa|1.3|-3.2|
71938178|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.5|||||TWO_SIDED|95.0|-3.3|0.2|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited systemic AE|PR5I minus INFANRIX™ hexa|0.2|-3.3|
71938179|NCT01341639|143397110|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.3|||||TWO_SIDED|95.0|-3.7|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related solicited systemic AE|PR5I minus INFANRIX™ hexa|1.1|-3.7|
71692761|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 4.|Wilcoxon test|||||||0.13
71692762|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7114||||||The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7114
71692763|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.|Wilcoxon test|||||||>0.9999
71692764|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.|Wilcoxon test|||||||0.38
71938180|NCT01341639|143397111|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.8|||||TWO_SIDED|95.0|-0.5|10.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site erythema|PR5I minus INFANRIX™ hexa|10.1|-0.5|
71938181|NCT01341639|143397111|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.8|||||TWO_SIDED|95.0|-3.2|6.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site pain|PR5I minus INFANRIX™ hexa|6.8|-3.2|
71938182|NCT01341639|143397111|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|4.0|||||TWO_SIDED|95.0|-1.6|9.6|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site swelling|PR5I minus INFANRIX™ hexa|9.6|-1.6|
71938183|NCT01341639|143397112|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.1|||||TWO_SIDED|95.0|-1.8|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site bruising|PR5I minus INFANRIX™ hexa|2.1|-1.8|
71938184|NCT01341639|143397112|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-0.6|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haematoma|PR5I minus INFANRIX™ hexa|2.1|-0.6|
71938185|NCT01341639|143397112|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.7|||||TWO_SIDED|95.0|-2.3|0.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haemorrhage|PR5I minus INFANRIX™ hexa|0.8|-2.3|
71938186|NCT01341639|143397112|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.7|||||TWO_SIDED|95.0|-7.8|0.5|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site induration|PR5I minus INFANRIX™ hexa|0.5|-7.8|
71938187|NCT01341639|143397112|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-0.2|||||TWO_SIDED|95.0|-1.7|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site nodule|PR5I minus INFANRIX™ hexa|1.3|-1.7|
71938188|NCT01341639|143397112|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|1.1||||||95.0|-0.6|3.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site warmth|PR5I minus INFANRIX™ hexa|3|-0.6|
71938189|NCT01341639|143397113|OTHER|Miettinen \& Nurminen method.|Risk Difference (RD)|-2.5|||||TWO_SIDED|95.0|-6.3|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Crying|PR5I minus INFANRIX™ hexa|1.4|-6.3|
71938190|NCT01341639|143397113|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-8.4|2.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Decreased appetite|PR5I minus INFANRIX™ hexa|2.3|-8.4|
71938191|NCT01341639|143397113|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|2.1|||||TWO_SIDED|95.0|-1.7|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Irritability|PR5I minus INFANRIX™ hexa|6|-1.7|
71938192|NCT01341639|143397113|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-1.7|||||TWO_SIDED|95.0|-6.7|3.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Pyrexia|PR5I minus INFANRIX™ hexa|3.4|-6.7|
71938193|NCT01341639|143397113|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|-3.2|||||TWO_SIDED|95.0|-7.8|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Somnolence|PR5I minus INFANRIX™ hexa|1.4|-7.8|
71938194|NCT01341639|143397113|OTHER|Miettinen \& Nurminen method|Risk Difference (RD)|0.8|||||TWO_SIDED|95.0|-4.4|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Vomiting|PR5I minus INFANRIX™ hexa|6|-4.4|
71938195|NCT01132118|143397142|SUPERIORITY_OR_OTHER|||||||0.93||||||Unadjusted|Wilcoxon (Mann-Whitney)|||The P-value calculated was for the difference betweeen the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.930
71938196|NCT01132118|143397142|SUPERIORITY_OR_OTHER|||||||0.785||||||Adjusted for weight change.|Regression, Linear|||The P-value was calculated for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.785
71938197|NCT01132118|143397143|SUPERIORITY_OR_OTHER|||||||0.575||||||Unadjusted P-value|Wilcoxon (Mann-Whitney)|||P-value for the difference between change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.575
71938198|NCT01132118|143397143|SUPERIORITY_OR_OTHER|||||||0.308||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.308
71938199|NCT01132118|143397144|SUPERIORITY_OR_OTHER|||||||0.468||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference betweeen change during hydroxychloroquine versus placebo suing Wilcoxon signed-rank tests.||||0.468
71938200|NCT01132118|143397144|SUPERIORITY_OR_OTHER|||||||0.902||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.902
71938201|NCT01132118|143397145|SUPERIORITY_OR_OTHER|||||||0.004||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.004
71938202|NCT01132118|143397145|SUPERIORITY_OR_OTHER|||||||0.004||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.004
71938203|NCT01132118|143397146|SUPERIORITY_OR_OTHER|||||||0.009||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.009
71938204|NCT01132118|143397146|SUPERIORITY_OR_OTHER|||||||0.011||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.011
71692765|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.91||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.|Wilcoxon test|||||||0.91
71938205|NCT01132118|143397147|SUPERIORITY_OR_OTHER|||||||0.73||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.730
71938206|NCT01132118|143397147|SUPERIORITY_OR_OTHER|||||||0.208||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.||||0.208
71938207|NCT01132118|143397148|SUPERIORITY_OR_OTHER|||||||0.487||||||Unadjusted P-value.|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.||||0.487
71938208|NCT01132118|143397148|SUPERIORITY_OR_OTHER|||||||0.884||||||P-value adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxycholorquine versus placebo from a linear regression model.||||0.884
71938209|NCT02192905|143397215|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 8.|Mean Difference (Final Values)|-0.64|STANDARD_DEVIATION|8.31||0.63|TWO_SIDED|95.0|-3.34|2.05|||t-test, 2 sided|||||2.05|-3.34|.63
71938210|NCT02192905|143397216|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 8.|Mean Difference (Final Values)|-0.019|STANDARD_DEVIATION|0.03|<|0.001|TWO_SIDED|95.0|-0.0285|-0.0096|||t-test, 2 sided|||||-.0096|-.0285|<0.001
71938211|NCT02192905|143397217|OTHER|One-sample t-test testing the mean within-person percent weight change from baseline to week 16.|Mean Difference (Final Values)|-0.017|STANDARD_DEVIATION|0.011||0.143|TWO_SIDED|95.0|-0.039|0.006|||t-test, 2 sided|||||.006|-.039|0.143
71938212|NCT02192905|143397218|OTHER|One-sample t-test testing the mean positive problem solving change from baseline to week 16.|Mean Difference (Final Values)|-0.76|STANDARD_DEVIATION|13.07||0.73|TWO_SIDED|95.0|-5.11|3.6|||t-test, 2 sided|||||3.6|-5.11|.73
71938213|NCT02232074|143397219|SUPERIORITY||Odds Ratio (OR)|0.82||||0.77|TWO_SIDED|95.0|0.21|3.14||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||3.14|0.21|0.77
71938214|NCT02232074|143397220|SUPERIORITY||Odds Ratio (OR)|4.0||||0.26|TWO_SIDED|95.0|0.35|45.4||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).||45.4|0.35|0.26
71938215|NCT02232074|143397221|SUPERIORITY||Median Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.42||0.53|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.53
71938216|NCT02232074|143397222|SUPERIORITY||Median Difference (Final Values)|-1.32|STANDARD_ERROR_OF_MEAN|1.62||0.43|TWO_SIDED|||||Adjusting for baseline Distress Thermometer scores.|Regression, Linear|||Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment||||0.43
71938217|NCT02232074|143397223|SUPERIORITY||Median Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.45||0.18|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.18
71938218|NCT02232074|143397224|SUPERIORITY||Median Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|1.29||0.33|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment||||0.33
71938219|NCT02232074|143397225|SUPERIORITY||Median Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.07||0.68|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.68
71938220|NCT02232074|143397226|SUPERIORITY||Median Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.15||0.26|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.26
71938221|NCT02232074|143397227|SUPERIORITY||Median Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|1.43||0.62|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.62
71938222|NCT02232074|143397228|SUPERIORITY||Median Difference (Final Values)|1.25|STANDARD_ERROR_OF_MEAN|2.91||0.69|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment||||0.69
71938223|NCT02232074|143397229|SUPERIORITY||Median Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.59||0.58|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.58
71938224|NCT02232074|143397230|SUPERIORITY||Median Difference (Final Values)|4.2|STANDARD_ERROR_OF_MEAN|2.21||0.09|TWO_SIDED||||||Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.||||0.09
71938225|NCT02232074|143397231|SUPERIORITY||Odds Ratio (OR)|0.85||||0.79|TWO_SIDED|95.0|0.28|2.79||a priori threshold for statistical significance p\<0.05|Regression, Logistic|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).||2.79|0.28|0.79
71938226|NCT02232074|143397232|SUPERIORITY||Median Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.5||0.71|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.||||0.71
71938227|NCT02232074|143397233|SUPERIORITY||Median Difference (Final Values)|-1.45|STANDARD_DEVIATION|2.71||0.61|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment||||0.61
71938228|NCT02232074|143397234|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_DEVIATION|0.08||0.46|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.46
71938229|NCT02232074|143397235|SUPERIORITY||Median Difference (Final Values)|-0.03|STANDARD_DEVIATION|0.2||0.89|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.89
71938230|NCT02232074|143397236|SUPERIORITY||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|1.66||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
71938231|NCT02232074|143397237|SUPERIORITY||Mean Difference (Final Values)|-4.83|STANDARD_DEVIATION|2.93||0.16|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.16
71938232|NCT02232074|143397238|SUPERIORITY||Mean Difference (Final Values)|1.14|STANDARD_DEVIATION|0.75||0.13|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.13
71938233|NCT02232074|143397239|SUPERIORITY||Mean Difference (Final Values)|0.97|STANDARD_DEVIATION|3.7||0.8|TWO_SIDED|||||a priori threshold for statistical significance p\<0.05|Regression, Linear|||||||0.80
71938234|NCT02322879|143397261|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
71938235|NCT00810732|143397277|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.56|STANDARD_ERROR_OF_MEAN|0.19||0.004|TWO_SIDED|95.0|-0.94|-0.19|||ANCOVA|||||-0.19|-0.94|0.0040
71938236|NCT00810732|143397277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.0018|TWO_SIDED|95.0|-0.99|-0.24|||ANCOVA|||||-0.24|-0.99|0.0018
71938237|NCT00810732|143397277|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.19||0.7945|TWO_SIDED|95.0|-0.33|0.43|||ANCOVA|||||0.43|-0.33|0.7945
71938238|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.5|STANDARD_ERROR_OF_MEAN|1.3||0.0087|TWO_SIDED|95.0|-6.08|-0.91|||ANCOVA|||Mean Systemic Arterial BP: Week 3||-0.91|-6.08|0.0087
71938239|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.92|STANDARD_ERROR_OF_MEAN|1.3||0.1424|TWO_SIDED|95.0|-4.5|0.66|||ANCOVA|||Mean Systemic Arterial BP: Week 3||0.66|-4.50|0.1424
71938240|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.58|STANDARD_ERROR_OF_MEAN|1.29||0.2277|TWO_SIDED|95.0|-4.15|1.0|||ANCOVA|||Mean Systemic Arterial BP: Week 3||1.00|-4.15|0.2277
71938241|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.56|STANDARD_ERROR_OF_MEAN|1.81||0.1599|TWO_SIDED|95.0|-6.16|1.03|||ANCOVA|||Systolic Blood Pressure: Week 3||1.03|-6.16|0.1599
71938242|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.07|STANDARD_ERROR_OF_MEAN|1.8||0.5545|TWO_SIDED|95.0|-4.66|2.52|||ANCOVA|||Systolic Blood Pressure: Week 3||2.52|-4.66|0.5545
71938243|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.49|STANDARD_ERROR_OF_MEAN|1.8||0.4095|TWO_SIDED|95.0|-5.08|2.09|||ANCOVA|||Systolic Blood Pressure: Week 3||2.09|-5.08|0.4095
71938244|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-4.08|STANDARD_ERROR_OF_MEAN|1.21||0.0012|TWO_SIDED|95.0|-6.49|-1.67|||ANCOVA|||Diastolic Blood Pressure: Week 3||-1.67|-6.49|0.0012
71938245|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.98|STANDARD_ERROR_OF_MEAN|1.21||0.0159|TWO_SIDED|95.0|-5.38|-0.57|||ANCOVA|||Diastolic Blood Pressure: Week 3||-0.57|-5.38|0.0159
71938246|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-1.1|STANDARD_ERROR_OF_MEAN|1.21||0.3627|TWO_SIDED|95.0|-3.51|1.3|||ANCOVA|||Diastolic Blood Pressure: Week 3||1.30|-3.51|0.3627
71938247|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.36|STANDARD_ERROR_OF_MEAN|1.16||0.0057|TWO_SIDED|95.0|-5.69|-1.03|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-1.03|-5.69|0.0057
71938248|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.53|STANDARD_ERROR_OF_MEAN|1.16||0.6503|TWO_SIDED|95.0|-2.86|1.8|||ANCOVA|||Mean Systemic Arterial BP: Week 6||1.80|-2.86|0.6503
71938249|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.83|STANDARD_ERROR_OF_MEAN|1.16||0.0183|TWO_SIDED|95.0|-5.16|-0.5|||ANCOVA|||Mean Systemic Arterial BP: Week 6||-0.50|-5.16|0.0183
71938250|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.81|STANDARD_ERROR_OF_MEAN|1.53||0.0726|TWO_SIDED|95.0|-5.89|0.27|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.27|-5.89|0.0726
71938251|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.07|STANDARD_ERROR_OF_MEAN|1.53||0.9661|TWO_SIDED|95.0|-3.01|3.14|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||3.14|-3.01|0.9661
71938252|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.88|STANDARD_ERROR_OF_MEAN|1.53||0.0656|TWO_SIDED|95.0|-5.94|0.19|||ANCOVA|||Systolic Blood Pressure (SBP): Week 6||0.19|-5.94|0.0656
71938253|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-3.16|STANDARD_ERROR_OF_MEAN|1.11||0.0068|TWO_SIDED|95.0|-5.39|-0.92|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||-0.92|-5.39|0.0068
71938254|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.99|STANDARD_ERROR_OF_MEAN|1.11||0.376|TWO_SIDED|95.0|-3.22|1.24|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||1.24|-3.22|0.3760
71938255|NCT00810732|143397278|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-2.16|STANDARD_ERROR_OF_MEAN|1.11||0.0572|TWO_SIDED|95.0|-4.4|0.07|||ANCOVA|||Diastolic Blood Pressure (DBP): Week 6||0.07|-4.40|0.0572
71938256|NCT00810732|143397279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.03|STANDARD_ERROR_OF_MEAN|0.21||0.8823|TWO_SIDED|95.0|-0.39|0.45|||ANCOVA|||Week 3||0.45|-0.39|0.8823
71938257|NCT00810732|143397279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.01|STANDARD_ERROR_OF_MEAN|0.21||0.9457|TWO_SIDED|95.0|-0.41|0.43|||ANCOVA|||Week 3||0.43|-0.41|0.9457
71938258|NCT00810732|143397279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.02|STANDARD_ERROR_OF_MEAN|0.21||0.9358|TWO_SIDED|95.0|-0.4|0.44|||ANCOVA|||Week 3||0.44|-0.40|0.9358
71938259|NCT00810732|143397279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.64|STANDARD_ERROR_OF_MEAN|0.19||0.0022|TWO_SIDED|95.0|-1.03|-0.25|||ANCOVA|||Week 6||-0.25|-1.03|0.0022
71938260|NCT00810732|143397279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8956|TWO_SIDED|95.0|-0.41|0.36|||ANCOVA|||Week 6||0.36|-0.41|0.8956
71938261|NCT00810732|143397279|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|-0.61|STANDARD_ERROR_OF_MEAN|0.19||0.003|TWO_SIDED|95.0|-1.0|-0.23|||ANCOVA|||Week 6||-0.23|-1.00|0.0030
71938262|NCT03734237|143397291|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1|Risk Ratio (RR)|-26.7||||0.1412|TWO_SIDED|95.0|-73.7|7.6|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||7.6|-73.7|0.1412
71938263|NCT03734237|143397291|EQUIVALENCE|Null Hypothesis: RR=1, Alternative hypothesis: RR not equal to 1.|Risk Ratio (RR)|-13.1||||0.4552|TWO_SIDED|95.0|-56.4|18.2|||Chi-squared|||Relative vaccine effectiveness with the outcome laboratory confirmed influenza identified via surveillance and/or abstracted from clinical records.||18.2|-56.4|0.4552
71938264|NCT02398188|143397302|SUPERIORITY|||||||0.397|||||||Cochran-Mantel-Haenszel|||||||0.397
71938265|NCT02398188|143397303|SUPERIORITY|||||||0.379|||||||Cochran-Mantel-Haenszel|||||||0.379
71938266|NCT00782509|143397305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.151|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.116|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.185|0.116|<0.0001
71938267|NCT00782509|143397305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.143|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.11|0.177|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.177|0.110|<0.0001
71938268|NCT00782509|143397306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.047|STANDARD_ERROR_OF_MEAN|0.019||0.0116||95.0|0.011|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.084|0.011|0.0116
71938269|NCT00782509|143397306|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.019||0.0095||95.0|0.012|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.085|0.012|0.0095
71692766|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2666||||||The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2666
71692767|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.88
71692768|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.45||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test|||||||0.45
71938270|NCT00782509|143397307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.027|<|0.0001||95.0|0.057|0.162|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.162|0.057|<0.0001
71938271|NCT00782509|143397307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089|STANDARD_ERROR_OF_MEAN|0.027||0.0011||95.0|0.036|0.143|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.143|0.036|0.0011
71938272|NCT00782509|143397308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.131|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.131|<0.0001
71938273|NCT00782509|143397308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.171|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.138|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.204|0.138|<0.0001
71938274|NCT00782509|143397309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.163|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.13|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.197|0.130|<0.0001
71938275|NCT00782509|143397309|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.152|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.119|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.186|0.119|<0.0001
71938276|NCT00782509|143397310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.169|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.135|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.135|<0.0001
71938277|NCT00782509|143397310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.017|<|0.0001||95.0|0.127|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.195|0.127|<0.0001
71938278|NCT00782509|143397311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.165|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.131|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.200|0.131|<0.0001
71938279|NCT00782509|143397311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.102|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.102|<0.0001
71938280|NCT00782509|143397312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.161|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.127|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.196|0.127|<0.0001
71938281|NCT00782509|143397312|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.158|STANDARD_ERROR_OF_MEAN|0.013|<|0.0001||95.0|0.123|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.193|0.123|<0.0001
71938282|NCT00782509|143397313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.053|STANDARD_ERROR_OF_MEAN|0.018||0.0043||95.0|0.017|0.089|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.089|0.017|0.0043
71938283|NCT00782509|143397313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.065|STANDARD_ERROR_OF_MEAN|0.018||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.101|0.028|0.0005
71938284|NCT00782509|143397314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.073|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.037|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.110|0.037|<0.0001
71692769|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 4.|Wilcoxon test|||||||0.36
71938285|NCT00782509|143397314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.049|0.121|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.121|0.049|<0.0001
71938286|NCT00782509|143397315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0002
71692770|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0076||||||The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0076
71692771|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.38||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.|Wilcoxon test|||||||0.38
71692772|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.22||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.|Wilcoxon test|||||||0.22
71938287|NCT00782509|143397315|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.019||0.0186||95.0|0.007|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.081|0.007|0.0186
71938288|NCT00782509|143397316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.032|0.0003
71938289|NCT00782509|143397316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.002||95.0|0.021|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.095|0.021|0.0020
71938290|NCT00782509|143397317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.058|STANDARD_ERROR_OF_MEAN|0.019||0.0024||95.0|0.02|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.095|0.020|0.0024
71938291|NCT00782509|143397317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.027|STANDARD_ERROR_OF_MEAN|0.019||0.1614||95.0|-0.011|0.064|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.064|-0.011|0.1614
71938292|NCT00782509|143397318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.019||0.0012||95.0|0.025|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.099|0.025|0.0012
71938293|NCT00782509|143397318|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.072|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.034|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.109|0.034|0.0002
71938294|NCT00782509|143397319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068|STANDARD_ERROR_OF_MEAN|0.019||0.0004||95.0|0.031|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.106|0.031|0.0004
71938295|NCT00782509|143397319|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.071|STANDARD_ERROR_OF_MEAN|0.019||0.0002||95.0|0.033|0.108|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.108|0.033|0.0002
71938296|NCT00782509|143397320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.168|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.132|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.203|0.132|<0.0001
71938297|NCT00782509|143397320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.177|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.142|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.212|0.142|<0.0001
71938298|NCT00782509|143397321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.119|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.190|0.119|<0.0001
71938299|NCT00782509|143397321|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.111|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.182|0.111|<0.0001
71692773|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.|Wilcoxon test|||||||0.10
71692774|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7144||||||The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.7144
71938300|NCT00782509|143397322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.209|0.136|<0.0001
71938301|NCT00782509|143397322|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.166|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.13|0.202|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.202|0.130|<0.0001
71692775|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.|Wilcoxon test|||||||0.13
71692776|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.06||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.|Wilcoxon test|||||||0.06
71692777|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.|Wilcoxon test|||||||0.13
71692778|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3741||||||The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3741
71692779|NCT01519817|142900525|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
71692780|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.13||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.|Wilcoxon test|||||||0.13
71692781|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.|Wilcoxon test|||||||>0.9999
71692782|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3386||||||The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.3386
71692783|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.|Wilcoxon test|||||||0.88
71692784|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0215||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.|Wilcoxon test|||||||0.0215
71938302|NCT00782509|143397323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.108|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.180|0.108|<0.0001
71938303|NCT00782509|143397323|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.018|<|0.0001||95.0|0.094|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.166|0.094|<0.0001
71938304|NCT00782509|143397324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.164|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.201|0.128|<0.0001
71938305|NCT00782509|143397324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.135|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.098|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.171|0.098|<0.0001
71938306|NCT00782509|143397325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.155|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.118|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.192|0.118|<0.0001
71938307|NCT00782509|143397325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.157|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001||95.0|0.12|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.194|0.120|<0.0001
71938308|NCT00782509|143397326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.331|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.263|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.399|0.263|<0.0001
71938309|NCT00782509|143397326|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.034|<|0.0001||95.0|0.265|0.4|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.400|0.265|<0.0001
71938310|NCT00782509|143397327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.242|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.174|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.310|0.174|<0.0001
71938311|NCT00782509|143397327|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.159|0.294|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.294|0.159|<0.0001
71692785|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.65||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.|Wilcoxon test|||||||0.65
71692786|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5076||||||The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5076
71938312|NCT00782509|143397328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.263|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.195|0.332|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.332|0.195|<0.0001
71938313|NCT00782509|143397328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.246|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.178|0.315|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.315|0.178|<0.0001
71692787|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.|Wilcoxon test|||||||0.63
71938314|NCT00782509|143397329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.17|0.308|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.308|0.170|<0.0001
71692788|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.68||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.|Wilcoxon test|||||||0.68
71938315|NCT00782509|143397329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.245|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.176|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.314|0.176|<0.0001
71938316|NCT00782509|143397330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.171|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.311|0.171|<0.0001
71692789|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.73||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.|Wilcoxon test|||||||0.73
71938317|NCT00782509|143397330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.219|STANDARD_ERROR_OF_MEAN|0.035|<|0.0001||95.0|0.15|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.289|0.150|<0.0001
71938318|NCT00782509|143397331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.217|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.147|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.288|0.147|<0.0001
71938319|NCT00782509|143397331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.218|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.148|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.288|0.148|<0.0001
71938320|NCT00782509|143397332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.059|STANDARD_ERROR_OF_MEAN|0.037||0.104||95.0|-0.012|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.131|-0.012|0.1040
71938321|NCT00782509|143397332|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.087|STANDARD_ERROR_OF_MEAN|0.036||0.0172||95.0|0.015|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.158|0.015|0.0172
71938322|NCT00782509|143397333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.094|STANDARD_ERROR_OF_MEAN|0.037||0.0106||95.0|0.022|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.166|0.022|0.0106
71938323|NCT00782509|143397333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.118|STANDARD_ERROR_OF_MEAN|0.037||0.0013||95.0|0.046|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.190|0.046|0.0013
71938324|NCT00782509|143397334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.037||0.3821||95.0|-0.04|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.105|-0.040|0.3821
71938325|NCT00782509|143397334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.037||0.1917||95.0|-0.024|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.120|-0.024|0.1917
71938326|NCT00782509|143397335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.037||0.1808||95.0|-0.023|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.123|-0.023|0.1808
71938327|NCT00782509|143397335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.037||0.37||95.0|-0.039|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.106|-0.039|0.3700
71938328|NCT00782509|143397336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.045|STANDARD_ERROR_OF_MEAN|0.037||0.2312||95.0|-0.029|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.118|-0.029|0.2312
71938329|NCT00782509|143397336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.037||0.0596||95.0|-0.003|0.144|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.144|-0.003|0.0596
71692790|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6577||||||The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6577
71692791|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.88||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.|Wilcoxon test|||||||0.88
71938330|NCT00782509|143397337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038|STANDARD_ERROR_OF_MEAN|0.037||0.311||95.0|-0.036|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.111|-0.036|0.3110
71692792|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.74||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.|Wilcoxon test|||||||0.74
71692793|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.|Wilcoxon test|||||||0.20
71938331|NCT00782509|143397337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.003|STANDARD_ERROR_OF_MEAN|0.038||0.9426||95.0|-0.076|0.071|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.071|-0.076|0.9426
71938332|NCT00782509|143397338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.038||0.268||95.0|-0.032|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.115|-0.032|0.2680
71938333|NCT00782509|143397338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.069|STANDARD_ERROR_OF_MEAN|0.038||0.0662||95.0|-0.005|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.143|-0.005|0.0662
71938334|NCT00782509|143397339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.038||0.2249||95.0|-0.028|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.120|-0.028|0.2249
71938335|NCT00782509|143397339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.062|STANDARD_ERROR_OF_MEAN|0.038||0.0994||95.0|-0.012|0.136|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.136|-0.012|0.0994
71938336|NCT00782509|143397340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.332|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.261|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.403|0.261|<0.0001
71938337|NCT00782509|143397340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.333|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.263|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.403|0.263|<0.0001
71938338|NCT00782509|143397341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.225|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.153|0.296|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.296|0.153|<0.0001
71938339|NCT00782509|143397341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.036|<|0.0001||95.0|0.139|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.139|<0.0001
71938340|NCT00782509|143397342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.268|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.196|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.340|0.196|<0.0001
71692794|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6295||||||The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6295
71692795|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.63||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.|Wilcoxon test|||||||0.63
71938341|NCT00782509|143397342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.251|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.179|0.323|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.323|0.179|<0.0001
71938342|NCT00782509|143397343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.154|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.298|0.154|<0.0001
71938343|NCT00782509|143397343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.209|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.137|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.281|0.137|<0.0001
71938344|NCT00782509|143397344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.226|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.153|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.299|0.153|<0.0001
71938345|NCT00782509|143397344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.206|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.279|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.279|0.133|<0.0001
71938346|NCT00782509|143397345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.207|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.133|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|||0.280|0.133|<0.0001
71692796|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.999||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.|Wilcoxon test|||||||>0.999
71692797|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.|Wilcoxon test|||||||0.36
71692798|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8314||||||The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.8314
71692799|NCT01519817|142900525|NON_INFERIORITY|The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.||||||0.63|||||||Wilcoxon test|||||||0.63
71692800|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.64||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.|Wilcoxon test|||||||0.64
71692801|NCT01519817|142900525|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.|Wilcoxon test|||||||0.30
71692802|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.|Wilcoxon test|||||||0.375
71692803|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4808||||||The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4808
71692804|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7334||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.|Wilcoxon test|||||||0.7334
71692805|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.7109||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.|Wilcoxon|||||||0.7109
71692806|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4347||||||The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4347
71692807|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.|Wilcoxon|||||||>0.9999
71692808|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.748||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.|Wilcoxon test|||||||0.748
71692809|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4.||||||0.8203
71692810|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5625||||||The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.5625
71692811|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
71692812|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
71938347|NCT00782509|143397345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211|STANDARD_ERROR_OF_MEAN|0.037|<|0.0001||95.0|0.138|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|||0.285|0.138|<0.0001
71938348|NCT00782509|143397346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.142|STANDARD_ERROR_OF_MEAN|0.047||0.0028||95.0|0.049|0.235|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo|||0.235|0.049|0.0028
71938349|NCT00782509|143397346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.156|STANDARD_ERROR_OF_MEAN|0.048||0.0013||95.0|0.061|0.25|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo|||0.250|0.061|0.0013
71938350|NCT00782509|143397347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.36|STANDARD_ERROR_OF_MEAN|4.959||0.0072|TWO_SIDED|95.0|3.622|23.099|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||23.099|3.622|0.0072
71938351|NCT00782509|143397347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.934|STANDARD_ERROR_OF_MEAN|4.894|<|0.0001|TWO_SIDED|95.0|11.323|30.545|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.545|11.323|<0.0001
71938352|NCT00782509|143397348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.456|STANDARD_ERROR_OF_MEAN|5.201||0.0169|TWO_SIDED|95.0|2.242|22.67|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||22.670|2.242|0.0169
71938353|NCT00782509|143397348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.653|STANDARD_ERROR_OF_MEAN|5.132|<|0.0001|TWO_SIDED|95.0|10.574|30.731|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||30.731|10.574|<0.0001
71938354|NCT00782509|143397349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.416|STANDARD_ERROR_OF_MEAN|0.127||0.0011|TWO_SIDED|95.0|-0.665|-0.167|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.167|-0.665|0.0011
71938355|NCT00782509|143397349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.513|STANDARD_ERROR_OF_MEAN|0.125|<|0.0001|TWO_SIDED|95.0|-0.76|-0.267|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.267|-0.760|<0.0001
71938356|NCT00782509|143397350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.157||0.0077|TWO_SIDED|95.0|-0.729|-0.111|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.111|-0.729|0.0077
71938357|NCT00782509|143397350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76|STANDARD_ERROR_OF_MEAN|0.155|<|0.0001||95.0|-1.065|-0.456|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.456|-1.065|<0.0001
71938358|NCT00782509|143397351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.837|STANDARD_ERROR_OF_MEAN|0.252||0.001|TWO_SIDED|95.0|-1.333|-0.342|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.342|-1.333|0.0010
71938359|NCT00782509|143397351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.278|STANDARD_ERROR_OF_MEAN|0.249|<|0.0001|TWO_SIDED|95.0|-1.767|-0.789|||ANCOVA|non-MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||||-0.789|-1.767|<0.0001
71938360|NCT00782509|143397352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0122||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0122
71938361|NCT00782509|143397352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.1||0.0008||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0008
71938362|NCT00782509|143397353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0028||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.1|-0.5|0.0028
71938363|NCT00782509|143397353|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0169||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.0|-0.5|0.0169
71938364|NCT00782509|143397354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.018||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||-0.0|-0.5|0.0180
71692813|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14|Wilcoxon test|||||||0.5
71692814|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6846||||||The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.6846
71692815|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
71692816|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.5||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.|Wilcoxon test|||||||0.5
71692817|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
71692818|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4375||||||The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.4375
71692819|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.|Wilcoxon test|||||||>0.9999
71692820|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.|Wilcoxon test|||||||>0.9999
71692821|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.75||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.|Wilcoxon test|||||||0.75
71692822|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.4525||||||The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.||||||0.4525
71692823|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|Wilcoxon test|||||||0.875
71692824|NCT01519817|142900526|NON_INFERIORITY|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.||||||0.4316|||||||Wilcoxon test|||Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||0.4316
71692825|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.|Wilcoxon test|||||||>0.9999
71692826|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9906||||||The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.9906
71692827|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1.||||||0.625
71692828|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.791||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.|Wilcoxon test|||||||0.791
71692829|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.8203||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.|Wilcoxon test|||||||0.8203
71938365|NCT00782509|143397354|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0015||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.6|0.0015
71938366|NCT00782509|143397355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1313||95.0|-0.4|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo|||0.0|-0.4|0.1313
71692830|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||>0.9999
71692831|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.|Wilcoxon test|||||||0.875
71692832|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.9658||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.|Wilcoxon test|||||||0.9658
71692833|NCT01519817|142900526|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6523||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.|Wilcoxon test|||||||0.6523
71692834|NCT01519817|142900527|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2901||||||The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.2901
71692835|NCT01519817|142900527|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.375||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.|Wilcoxon test|||||||0.375
71692836|NCT01519817|142900527|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2036||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.|Wilcoxon test|||||||0.2036
71938367|NCT00782509|143397355|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0089||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo|||-0.1|-0.5|0.0089
71692837|NCT01519817|142900527|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0742||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.|Wilcoxon test|||||||0.0742
71692838|NCT01519817|142900528|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.1004||||||The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.1004
71692839|NCT01519817|142900528|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.625||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.625
71692840|NCT01519817|142900528|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.6772||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.6772
71692841|NCT01519817|142900528|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
71692842|NCT01519817|142900529|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.0621||||||The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n\>2 to do paired analyses.|Wilcoxon test|||||||0.0621
71692843|NCT01519817|142900529|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.875||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.|Wilcoxon test|||||||0.875
71692844|NCT01519817|142900529|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.2402||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.|Wilcoxon test|||||||0.2402
71692845|NCT01519817|142900529|NON_INFERIORITY|Significance was met if the unadjusted p-value was \<0.05 and \>1/2 of patients had a serum level change of \>25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.|Wilcoxon test|||||||0.3008
71938368|NCT00782509|143397356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.993|STANDARD_ERROR_OF_MEAN|0.187||0.9853|TWO_SIDED|95.0|0.687|1.436|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.436|0.687|0.9853
71692846|NCT04547140|142900599|SUPERIORITY||Difference in percentages|3.3|||||TWO_SIDED|||||||||Percentage of Participants Dying||||
71692847|NCT04547140|142900599|SUPERIORITY||Difference in percentages|6.4|||||TWO_SIDED|||||||||Percentage of Participants Requiring ICU Admission||||
71692848|NCT04547140|142900600|SUPERIORITY||Difference in percentages|6.9|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on High Flow Oxygen Devices||||
71692849|NCT04547140|142900600|SUPERIORITY||Difference in percentages|3.4|||||TWO_SIDED|||||||||Percentage of Participants Who are Dependent on Invasive Mechanical Ventilation||||
71692850|NCT04547140|142900601|SUPERIORITY||Least Squares (LS) Mean Difference|1.22||||0.1453|TWO_SIDED|95.0|-0.43|2.87||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||2.87|-0.43|0.1453
71938369|NCT00782509|143397356|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|STANDARD_ERROR_OF_MEAN|0.222||0.2344|TWO_SIDED|95.0|0.873|1.763|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||1.763|0.873|0.2344
71938370|NCT00782509|143397357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.05|STANDARD_ERROR_OF_MEAN|0.438||0.9035|TWO_SIDED|95.0|0.463|2.38|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||2.380|0.463|0.9035
71692851|NCT04547140|142900601|SUPERIORITY||LS Mean Difference|0.21||||0.8015|TWO_SIDED|95.0|-1.44|1.86||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||1.86|-1.44|0.8015
71692852|NCT04547140|142900603|SUPERIORITY||LS Mean Difference of Duration|1.48||||0.5135|TWO_SIDED|95.0|-3.04|6.0||P-value was calculated using an analysis of variance (ANOVA) model, including the length of hospital stay (days) as a dependent variable and treatment group as a fixed effect.|ANOVA|||||6.00|-3.04|0.5135
71692853|NCT04547140|142900604|SUPERIORITY||LS Mean Difference of Duration|3.41||||0.1221|TWO_SIDED|95.0|-0.94|7.76||P-value was calculated using an ANOVA model, including the number of days in the ICU as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.76|-0.94|0.1221
71692854|NCT04547140|142900605|SUPERIORITY||LS Mean Difference of Duration|2.78||||0.3329|TWO_SIDED|95.0|-2.92|8.48||P-value was calculated using an ANOVA model, including the number of days on oxygen as a dependent variable and treatment group as a fixed effect.|ANOVA|||||8.48|-2.92|0.3329
71938371|NCT00782509|143397357|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.958|STANDARD_ERROR_OF_MEAN|0.408||0.9304|TWO_SIDED|95.0|0.415|2.209|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.209|0.415|0.9304
71938372|NCT00782509|143397358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.09|STANDARD_ERROR_OF_MEAN|0.233||0.669|TWO_SIDED|95.0|0.717|1.657|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum|||1.657|0.717|0.6690
71938373|NCT00782509|143397358|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.344|STANDARD_ERROR_OF_MEAN|0.273||0.1437|TWO_SIDED|95.0|0.902|2.002|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum|||2.002|0.902|0.1437
71692855|NCT04547140|142900606|SUPERIORITY||LS Mean Difference of Duration|3.48||||0.1092|TWO_SIDED|95.0|-0.81|7.77||P-value was calculated using an ANOVA model, including the number of days on mechanical ventilation as a dependent variable and treatment group as a fixed effect.|ANOVA|||||7.77|-0.81|0.1092
71692856|NCT04547140|142900607|SUPERIORITY||LS Mean Difference|-0.63||||0.1189|TWO_SIDED|95.0|-1.43|0.17||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 15||0.17|-1.43|0.1189
71692857|NCT04547140|142900607|SUPERIORITY||LS Mean Difference|-0.85||||0.0341|TWO_SIDED|95.0|-1.64|-0.07||P-value was calculated using restricted maximum likelihood with the Kenward-Roger method for calculating the denominator degrees of freedom.|Kenward-Roger|||Day 29||-0.07|-1.64|0.0341
71692858|NCT04547140|142900611|SUPERIORITY||Difference in percentages|1.9||||0.8809|TWO_SIDED|95.0|-24.1|28.3||P-value was calculated using Chi-square test with 5% level of significance to test the null hypothesis of no difference in the percentages of participants experiencing sustained normalization of fever.|Chi-squared|||||28.3|-24.1|0.8809
71692859|NCT00737100|142900634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94||||0.001||95.0|1.19|4.7||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.70|1.19|0.001
71938374|NCT00782509|143397359|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.188|STANDARD_ERROR_OF_MEAN|0.2251||0.3637|TWO_SIDED|95.0|0.8188|1.7234|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.7234|0.8188|0.3637
71938375|NCT00782509|143397359|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2822|STANDARD_ERROR_OF_MEAN|0.2403||0.1853|TWO_SIDED|95.0|0.8874|1.8527|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||1.8527|0.8874|0.1853
71938376|NCT00782509|143397360|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.0314|STANDARD_ERROR_OF_MEAN|0.4664||0.9455|TWO_SIDED|95.0|0.4244|2.5063|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||2.5063|0.4244|0.9455
71938377|NCT00782509|143397360|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.1273|STANDARD_ERROR_OF_MEAN|0.5028||0.7883|TWO_SIDED|95.0|0.4696|2.7064|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.7064|0.4696|0.7883
71938378|NCT00782509|143397361|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.2846|STANDARD_ERROR_OF_MEAN|0.2803||0.2514|TWO_SIDED|95.0|0.837|1.9717|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo|||1.9717|0.8370|0.2514
71938379|NCT00782509|143397361|SUPERIORITY_OR_OTHER||Incidence rate ratio|1.3373|STANDARD_ERROR_OF_MEAN|0.2901||0.1807|TWO_SIDED|95.0|0.8735|2.0474|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo|||2.0474|0.8735|0.1807
71938380|NCT01176448|143397365|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.||||||0.77||95.0||||Appropriately powered, this study failed to reject the null hypothesis that fraxel achieves a similar cosmetic result at 3 months when compared to dermabrasion.|Wilcoxon (Mann-Whitney)|||efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group's scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categories||||.77
71938381|NCT04041570|143397376|OTHER|t-tests were only employed to determine which individuals were responders. Response rates with 95% Clopper-Pearson confidence intervals were reported within group.||||||0.05||||||The p-value was not adjusted for multiple comparisons and was only used to assess whether participants had a positive response or not.|t-test, 1 sided|This test was only used to determine whether participants were positive responders or not.||Statistical testing was performed within group and not between groups. Positivity for an individual was determined if there was a significant (p-value\<0.05) increase (one-sided test) in the ELISA titers at week 4 when compared to those at baseline. For each participant a t-test was performed to compare the triplicate baseline titers to their triplicate week 4 titers. The proportion of positive responses and associated Clopper-Pearson 95% was calculated within group.|For each participant, a positive response was defined as a significant increase in ELISA titer post vaccination (Week 4) from baseline (Week 0). Within each participant, a t-test is performed to compare the triplicate readings (replicates 1-3) post vaccination versus the triplicate readings at baseline. A participant is defined as a positive responder if one-sided t-test has p-value \< 0.05. The proportion of responders and associated 95% Clopper-Pearson Confidence Intervals were calculated.|||0.05
71938382|NCT01111110|143397380|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|21.0|STANDARD_ERROR_OF_MEAN|6.7||0.026|TWO_SIDED|95.0|3.8|41.7|||t-test, 2 sided|two sample effect size must be halved to account for mean difference estimates twice the effect size|See 4 Puff result|(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.||41.7|3.8|0.026
71938383|NCT01111110|143397381|SUPERIORITY_OR_OTHER_LEGACY||half the mean difference|23.5|STANDARD_ERROR_OF_MEAN|6.8||0.018|TWO_SIDED|95.0|6.0|41.0||The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B|t-test, 2 sided|Must take half the mean difference to estimate effect size|No comments|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.||41.0|6.0|0.018
71938384|NCT01111110|143397382|SUPERIORITY_OR_OTHER_LEGACY||Effect size=half the mean diff|24.7|STANDARD_ERROR_OF_MEAN|6.6||0.013|TWO_SIDED|95.0|7.7|41.7|||t-test, 2 sided||You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.|Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1||41.7|7.7|0.013
71938385|NCT00384033|143397383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.198|TWO_SIDED|95.0|-0.6|2.7||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.||2.70|-0.60|0.198
71938386|NCT00384033|143397383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.028|TWO_SIDED|95.0|0.2|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.20|0.028
71692860|NCT00737100|142900634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.39||||0.0001||95.0|1.67|5.12||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.67|0.0001
71692861|NCT00737100|142900635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.24||||0.0184||95.0|0.38|4.11||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||4.11|0.38|0.0184
71692862|NCT00737100|142900635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22||||0.0179||95.0|0.38|4.06||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||4.06|0.38|0.0179
71692863|NCT00737100|142900636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.83||||0.0756||95.0|-0.19|3.86|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||3.86|-0.19|0.0756
71692864|NCT00737100|142900636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.12||||0.0023||95.0|1.12|5.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||5.12|1.12|0.0023
71692865|NCT00737100|142900637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85||||0.3857||95.0|-1.08|2.79|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||2.79|-1.08|0.3857
71938387|NCT00384033|143397383|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.047|TWO_SIDED|95.0|0.0|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.||3.40|0.00|0.047
71938388|NCT00384033|143397384|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.||||0.110
71938389|NCT00384033|143397384|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.009
71938390|NCT00384033|143397384|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.||||0.008
71938391|NCT00384033|143397385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.248|TWO_SIDED|95.0|-0.1|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.40|-0.10|0.248
71938392|NCT00384033|143397385|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.011|TWO_SIDED|95.0|0.1|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.10|0.011
71692866|NCT00737100|142900637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.19||||0.2199||95.0|-0.72|3.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||3.11|-0.72|0.2199
71692867|NCT00737100|142900638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.19||||0.0363||95.0|0.27|8.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||8.11|0.27|0.0363
71692868|NCT00737100|142900638|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.34||||0.0073||95.0|1.45|9.23|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||9.23|1.45|0.0073
71692869|NCT00737100|142900639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.7414||95.0|-0.06|0.08|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||0.08|-0.06|0.7414
71692870|NCT00737100|142900639|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05||||0.1418||95.0|-0.02|0.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||0.12|-0.02|0.1418
71692871|NCT00737100|142900640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.79||||0.8515||95.0|0.37|1.72|||Regression, Logistic|Covariates of treatment and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo||1.72|0.37|0.8515
71692872|NCT00737100|142900640|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.72||||0.5565||95.0|0.33|1.59|||Regression, Logistic|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo||1.59|0.33|0.5565
71692873|NCT04033146|142900665|OTHER||||||<|0.001||||||Threshold was 0.05|ANOVA|||"H1. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for young adults.~H2. Bilateral ankle exoskeletons that provide 'motor-like' assistance will result in lower net metabolic power than those providing 'spring-like' assistance for older adults."||||<0.001
71692874|NCT01064414|142900694|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.117||0.012|TWO_SIDED|95.0|-0.529|-0.066|||ANCOVA|||||-0.066|-0.529|0.012
71692875|NCT01064414|142900694|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.117|<|0.001|TWO_SIDED|95.0|-0.635|-0.174|||ANCOVA|||||-0.174|-0.635|<0.001
71692876|NCT01064414|142900695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.66||||0.227|TWO_SIDED|95.0|0.73|3.77|||Regression, Logistic|||||3.77|0.73|0.227
71938393|NCT00384033|143397385|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.3||||0.026|TWO_SIDED|95.0|0.0|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.||0.60|0.00|0.026
71938394|NCT00384033|143397386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7||||0.149|TWO_SIDED|95.0|-0.6|4.0||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||4.00|-0.60|0.149
71938395|NCT00384033|143397386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.004|TWO_SIDED|95.0|1.1|5.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.60|1.10|0.004
71938396|NCT00384033|143397386|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.4||||0.005|TWO_SIDED|95.0|1.1|5.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.||5.80|1.10|0.005
71938397|NCT00384033|143397387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.473|TWO_SIDED|95.0|-0.22|0.46||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.46|-0.22|0.473
71938398|NCT00384033|143397387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.27||||0.119|TWO_SIDED|95.0|-0.07|0.61||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.61|-0.07|0.119
71938399|NCT00384033|143397387|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.71|TWO_SIDED|95.0|-0.27|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.||0.40|-0.27|0.710
71938400|NCT00384033|143397388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.6||||0.215|TWO_SIDED|95.0|-0.3|1.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||1.50|-0.30|0.215
71938401|NCT00384033|143397388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3||||0.005|TWO_SIDED|95.0|0.4|2.3||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.30|0.40|0.005
71938402|NCT00384033|143397388|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.024|TWO_SIDED|95.0|0.2|2.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.||2.10|0.20|0.024
71938403|NCT00384033|143397389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.53||||0.1|TWO_SIDED|95.0|-0.1|1.17||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.17|-0.10|0.100
71938404|NCT00384033|143397389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.79||||0.014|TWO_SIDED|95.0|0.16|1.42||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.42|0.16|0.014
71938405|NCT00384033|143397389|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.72||||0.032|TWO_SIDED|95.0|0.06|1.38||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.||1.38|0.06|0.032
71938406|NCT00384033|143397390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.445|TWO_SIDED|95.0|-0.2|0.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.50|-0.20|0.445
71938407|NCT00384033|143397390|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.056|TWO_SIDED|95.0|0.0|0.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.70|-0.00|0.056
71938408|NCT00384033|143397390|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.5||||0.006|TWO_SIDED|95.0|0.1|0.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.||0.90|0.10|0.006
71938409|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.5||||0.124|TWO_SIDED|95.0|-0.9|7.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||7.90|-0.90|0.124
71938410|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.7||||0.035|TWO_SIDED|95.0|0.3|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||9.10|0.30|0.035
71938411|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|4.1||||0.093|TWO_SIDED|95.0|-0.7|8.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.||8.80|-0.70|0.093
71938412|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.1||||0.177|TWO_SIDED|95.0|-1.4|7.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||7.70|-1.40|0.177
71938413|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.6||||0.048|TWO_SIDED|95.0|0.1|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||9.10|0.10|0.048
71938414|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.8||||0.088|TWO_SIDED|95.0|-0.5|8.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.||8.10|-0.50|0.088
71938415|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.122|TWO_SIDED|95.0|-1.0|8.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||8.40|-1.00|0.122
71938416|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.8||||0.015|TWO_SIDED|95.0|1.1|10.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||10.50|1.10|0.015
71938417|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.2||||0.103|TWO_SIDED|95.0|-0.8|9.2||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.||9.20|-0.80|0.103
71938418|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.384|TWO_SIDED|95.0|-1.7|4.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.50|-1.70|0.384
71938419|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.221|TWO_SIDED|95.0|-1.2|5.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||5.10|-1.20|0.221
71938420|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.4||||0.411|TWO_SIDED|95.0|-1.9|4.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.||4.70|-1.90|0.411
71938421|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0||||0.412|TWO_SIDED|95.0|-2.8|6.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||6.70|-2.80|0.412
71938422|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.9||||0.042|TWO_SIDED|95.0|0.2|9.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||9.60|0.20|0.042
71938423|NCT00384033|143397391|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.3||||0.155|TWO_SIDED|95.0|-1.2|7.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.||7.80|-1.20|0.155
71938424|NCT00290745|143397410|OTHER|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||0.07
71938425|NCT00290745|143397411|OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in Tumor volume between baseline and Month 6||||<0.001
71938426|NCT00290745|143397414|OTHER|||||||0.538|||||||Kruskal-Wallis|||||||0.538
71938427|NCT00290745|143397415|OTHER|||||||0.02|||||||Kruskal-Wallis|||||||0.02
71938428|NCT00290745|143397416|OTHER|||||||0.714|||||||Kruskal-Wallis|||||||0.714
71938429|NCT00290745|143397417|OTHER|||||||0.001|||||||Kruskal-Wallis|||||||0.001
71938430|NCT00290745|143397418|OTHER|||||||0.906|||||||Kruskal-Wallis|||||||0.906
71938431|NCT02750306|143397419|SUPERIORITY||Difference in Least Squares Means|28.2||||0.00128|TWO_SIDED|95.0|11.1|45.2|||ANCOVA|||||45.2|11.1|0.00128
71938432|NCT02750306|143397422|SUPERIORITY||Difference in Least Squares Means|-15.7||||0.01354|TWO_SIDED|95.0|-28.1|-3.3|||ANCOVA|||||-3.3|-28.1|0.01354
71938433|NCT01166568|143397537|SUPERIORITY||binomial distribution|0.75||||0.025|ONE_SIDED|97.5|0.75|||the p-value is adjusted for multiple comparisons|Fisher Exact|||"The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint."|||0.75|0.025
71938434|NCT03335371|143397556|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_DEVIATION|0.087|<|0.0001|TWO_SIDED|95.0|-0.39|-0.04|||ANCOVA|||||-0.04|-0.39|<0.0001
71938435|NCT01656889|143397615|SUPERIORITY_OR_OTHER|||||||0.5896|TWO_SIDED||||||Cochran-Mantel-Haenszel|P-value is based on the chi-squared proportion of wounds closed in each group.||||||0.5896
71938436|NCT01656889|143397616|SUPERIORITY_OR_OTHER|||||||0.3675|TWO_SIDED|0.0|||||Regression, Cox|||||||.3675
71938437|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.6426|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 01||||0.6426
71938438|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.3843|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 02||||.3843
71938439|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.2792|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 03||||0.2792
71938440|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.1502|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 04||||0.1502
71692877|NCT01064414|142900695|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.69||||0.017|TWO_SIDED|95.0|1.19|6.04|||Regression, Logistic|||||6.04|1.19|0.017
71692878|NCT01064414|142900696|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-15.4|STANDARD_ERROR_OF_MEAN|6.638||0.021|TWO_SIDED|95.0|-28.45|-2.307|||ANCOVA|||||-2.307|-28.45|0.021
71938441|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.3823|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 05||||0.3823
71938442|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 06||||0.5528
71938443|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.02913|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 07||||.02913
71938444|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.3896|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 08||||0.3896
71938445|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.3989|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 09||||0.3989
71938446|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.8682|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 10||||0.8682
71938447|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.8083|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 11||||0.8083
71938448|NCT01656889|143397617|SUPERIORITY_OR_OTHER|||||||0.6687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Treatment Week 12||||0.6687
71938449|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.3601|TWO_SIDED||||||ANCOVA|||Week 01||||0.3601
71938450|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.9398|TWO_SIDED||||||ANCOVA|||Week 02||||0.9398
71938451|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.905|TWO_SIDED||||||ANCOVA|||Week 03||||0.905
71938452|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.4471|TWO_SIDED||||||ANCOVA|||Week 04||||0.4471
71938453|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.3004|TWO_SIDED||||||ANCOVA|||Week 05||||0.3004
71938454|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.1815|TWO_SIDED||||||ANCOVA|||Week 06||||0.1815
71938455|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANCOVA|||Week 07||||0.399
71692879|NCT01064414|142900696|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.2|STANDARD_ERROR_OF_MEAN|6.683||0.069|TWO_SIDED|95.0|-25.36|0.962|||ANCOVA|||||0.962|-25.36|0.069
71938456|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.8027|TWO_SIDED||||||ANCOVA|||Week 08||||0.8027
71938457|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.4913|TWO_SIDED||||||ANCOVA|||Week 09||||0.4913
71938458|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.5227|TWO_SIDED||||||ANCOVA|||Week 10||||0.5227
71938459|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.7032|TWO_SIDED||||||ANCOVA|||Week 11||||0.7032
71938460|NCT01656889|143397619|SUPERIORITY_OR_OTHER|||||||0.9366|TWO_SIDED||||||ANCOVA|||||||0.9366
71938461|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.9853|TWO_SIDED||||||ANCOVA|||Week 01||||0.9853
71938462|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.7083|TWO_SIDED||||||ANCOVA|||Week 02||||0.7083
71938463|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.6744|TWO_SIDED||||||ANCOVA|||Week 03||||0.6744
71938464|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.2891|TWO_SIDED||||||ANCOVA|||||||0.2891
71938465|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.9923|TWO_SIDED||||||ANCOVA|||Week 05||||0.9923
71938466|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.1775|TWO_SIDED||||||ANCOVA|||Week 06||||0.1775
71938467|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.499|TWO_SIDED||||||ANCOVA|||Week 07||||0.499
71938468|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.4423|TWO_SIDED||||||ANCOVA|||Week 08||||0.4423
71938469|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.5138|TWO_SIDED||||||ANCOVA|||Week 09||||0.5138
71938470|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.3409|TWO_SIDED||||||ANCOVA|||Week 10||||0.3409
71938471|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.6358|TWO_SIDED||||||ANCOVA|||Week 11||||0.6358
71938472|NCT01656889|143397620|SUPERIORITY_OR_OTHER|||||||0.6753|TWO_SIDED||||||ANCOVA|||Week 12||||0.6753
71938473|NCT01656889|143397621|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Kaplan-Meier Survival analysis|||||||< 0.05
71938474|NCT01379781|143397665|SUPERIORITY||Slope|-6.54||||0.01|TWO_SIDED||||||Mixed Models Analysis|||Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre-randomization assessment and the 6 weeks postpartum session.||||.01
71692880|NCT00249873|142900697|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89||||0.0133||95.0|0.81|0.98||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.|||0.98|0.81|0.0133
71692881|NCT00249873|142900698|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.72|||<|0.001||95.0|0.62|0.83||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.|||0.83|0.62|<0.001
71692882|NCT00249873|142900699|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.696||95.0|0.89|1.08||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.|||1.08|0.89|0.696
71692883|NCT00249873|142900700|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Chi-squared|||||||<0.001
71692884|NCT00643201|142900704|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing: non-inferiority tested at 1-sided α=0.025 with margin of 1.8. Demonstration of non-inferiority using both relative risk (RR) (margin = 1.8) and risk difference (RD) (margin = 0.035) were required to achieve the primary objective.|Risk Ratio (RR)|0.839|||<|0.0001|TWO_SIDED|95.0|0.5965|1.1802||This is the first test in a sequential testing sequence. p-value calculated based on the Yanagawa-Tango-Hiejima test stratified by index event strata for non-inferiority. Tested at 1-sided α=0.025|Yanagawa-Tango-Hiejima|For a successful trial; rejection of the null hypotheses for both RR and RD was required.||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatal PE)/VTE-related death.||1.1802|0.5965|<0.0001
71938475|NCT02708290|143397702|OTHER|Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.|Mean Difference (Final Values)|4.68|||<|0.0001|TWO_SIDED||||||Regression, Linear|||"The concept of a Visit was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis."||||<0.0001
71938476|NCT02688400|143397715|NON_INFERIORITY|"Non-inferiority of Diacerein versus Celecoxib was assessed by computing the difference in the adjusted mean change from baseline (Visit 2) in WOMAC Pain subscale score after 182 days of treatment between Diacerein and Celecoxib treatment groups from a MMRM.~Assuming that:~* Non inferiority margin of 10 points for the absolute change in WOMAC Pain Subscale Score (scale 0-100)~* SD of 26 in the two treatment groups,~* Type I error: α = 0.025 (one-sided condition) and power equal to 90%"|Mean Difference (Final Values)|0.67|||<|0.025|ONE_SIDED|95.0||3.18||MMRM. Non-inferiority claim:Diacerein to be non-inferior to Celecoxib if upper bound of the the difference in the adjusted mean change was inferior to 5 cm on the PPS.|Mixed Models Analysis|||||3.18||<0.025
71938477|NCT02688400|143397716|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71938478|NCT02688400|143397717|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71938479|NCT02688400|143397718|SUPERIORITY|||||||0.05|||||||Chi-squared|||||||0.05
71692885|NCT00643201|142900704|NON_INFERIORITY_OR_EQUIVALENCE|Statistical Testing; non-inferiority tested at 1-sided α=0.025. If non-inferiority demonstrated for both RR and RD, the primary objective was achieved.|Risk Difference (RD)|-0.0044|||<|0.0001|TWO_SIDED|95.0|-0.0128|0.004||Yanagawa-Tango-Hiejima test statistic for risk difference (RD).|Yanagawa-Tango-Hiejima|||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatalPE)/VTE-related death as measured by risk difference.||0.0040|-0.0128|<0.0001
71692886|NCT00643201|142900704|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.839||||0.3128|TWO_SIDED|95.0|0.5965|1.1802||Tested at 2-sided α=0.05 significance. Further inferential statistical testing halted due to failure to reject the null hypothesis of equivalence for VTE/VTE-related death.|Cochran-Mantel-Haenszel|Relative risk, CI, and p-value were calculated based on CMH test stratified by index event strata.||Hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing required demonstration of non-inferiority using both RR and RD plus demonstration of superiority for major bleeding.||1.1802|0.5965|0.3128
71938480|NCT02688400|143397719|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71938481|NCT02688400|143397720|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Chi-squared|||||||0.05
71938482|NCT02688400|143397721|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71938483|NCT02688400|143397722|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71938484|NCT02688400|143397723|SUPERIORITY|||||||0.05|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.05
71692887|NCT00643201|142900705|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.8151||||0.1554|TWO_SIDED|95.0|0.6146|1.0812||The test was stratified by index event strata using alpha=0.05 level of significance. Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.|Cochran-Mantel-Haenszel|Nominal p-value is reported.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0812|0.6146|0.1554
71692888|NCT00643201|142900706|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7994||||0.1848|TWO_SIDED|95.0|0.5737|1.1137||The test was stratified by index event strata using alpha=0.05 level of significance. . Nominal p-value is reported.|Cochran-Mantel-Haenszel|Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1137|0.5737|0.1848
71692889|NCT00643201|142900707|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6236||||0.0011|TWO_SIDED|95.0|0.4682|0.8306||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.8306|0.4682|0.0011
71692890|NCT00643201|142900708|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5532|||<|0.0001|TWO_SIDED|95.0|0.4658|0.6569||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6569|0.4658|<0.0001
71692891|NCT00643201|142900709|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6347|||||TWO_SIDED|95.0|0.3735|1.0787|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.0787|0.3735|
71692892|NCT00643201|142900710|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0935|||||TWO_SIDED|95.0|0.6363|1.8793|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.8793|0.6363|
71692893|NCT00643201|142900711|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7521|||||TWO_SIDED|95.0|0.356|1.5889|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.5889|0.3560|
71692894|NCT00643201|142900712|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6539|||||TWO_SIDED|95.0|0.3419|1.2508|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.2508|0.3419|
71692895|NCT00643201|142900713|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.7934|||||TWO_SIDED|95.0|0.5287|1.1906|||Cochran-Mantel-Haenszel||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||1.1906|0.5287|
71692896|NCT00643201|142900714|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.307|||<|0.0001|TWO_SIDED|95.0|0.1728|0.5452||p-value calculated on the CMH test stratified by index event strata.|Cochran-Mantel-Haenszel||Relative risk and CI were calculated based on CMH test stratified by index event strata.|Hypothesis: apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. As per the hierarchical statistical testing cascade, inferential testing for adjudicated major bleeding occurred because non-inferiority for VTE/VTE-related death (Primary efficacy endpoint) was demonstrated earlier. Rejection of the null hypothesis for equivalence for major bleeding allowed inferential testing for superiority of VTE/VTE-related death.||0.5452|0.1728|<0.0001
71692897|NCT00643201|142900715|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.441|||<|0.0001|TWO_SIDED|95.0|0.3566|0.5453||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing was not conducted because the null hypothesis pertaining to superiority for VTE/VTE-related death was not rejected.||0.5453|0.3566|<0.0001
71692898|NCT00643201|142900716|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4793|||<|0.0001|TWO_SIDED|95.0|0.3815|0.6022||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6022|0.3815|<0.0001
71692899|NCT00643201|142900717|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.6182|||<|0.0001|TWO_SIDED|95.0|0.5432|0.7034||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.7034|0.5432|<0.0001
71692900|NCT00643201|142900718|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.5937|||<|0.0001|TWO_SIDED|95.0|0.5318|0.6629||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.||0.6629|0.5318|<0.0001
71692901|NCT02346708|142900726|SUPERIORITY||Mean Difference (Final Values)|-2.07||||0.1|TWO_SIDED|95.0|-4.56|0.42||We determined whether there was a significant group difference between the real and sham treated PD-MCI patients on the DRS-2 change following rTMS using mixed model regression (MMR) to fit longitudinal models.|Mixed Models Analysis|degrees of freedom: 46||We estimated a sample size of 20 per group would provide at least 80% power at a significance level of 0.05 to detect a between-group difference of 10 on the Matthis Dementia Rating Scale-2, an effect size similar to prior studies of rivastigmine.||0.42|-4.56|0.1
71692902|NCT02976519|142900728|OTHER||Slope|1.2705|STANDARD_ERROR_OF_MEAN|0.0801|||TWO_SIDED|95.0|1.1067|1.4343|||||Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4343|1.1067|
71692903|NCT02976519|142900728|OTHER||Slope|1.1361|STANDARD_ERROR_OF_MEAN|0.0859|||TWO_SIDED|95.0|0.9598|1.3123|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.3123|0.9598|
71692904|NCT02976519|142900729|OTHER||Slope|1.2743|STANDARD_ERROR_OF_MEAN|0.0739|||TWO_SIDED|95.0|1.1231|1.4255|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.4255|1.1231|
71692905|NCT02976519|142900729|OTHER||Slope|1.0924|STANDARD_ERROR_OF_MEAN|0.0793|||TWO_SIDED|95.0|0.9296|1.2551|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.||1.2551|0.9296|
71692906|NCT03416270|142900730|OTHER|||||||0.36||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.36
71692907|NCT03416270|142900730|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
71692908|NCT03416270|142900731|OTHER|||||||0.303|||||||Wilcoxon (Mann-Whitney)|||||||0.303
71692909|NCT03416270|142900732|OTHER|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||||||0.438
71692910|NCT03416270|142900733|OTHER|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||||||0.599
71692911|NCT03416270|142900734|OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||||||0.92
71692912|NCT03416270|142900735|OTHER|||||||0.405|||||||Wilcoxon (Mann-Whitney)|||||||0.405
71692913|NCT03416270|142900736|OTHER|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||||||0.536
71692914|NCT03416270|142900737|OTHER|||||||0.443|||||||Wilcoxon (Mann-Whitney)|||||||0.443
71692915|NCT03416270|142900738|OTHER|||||||0.849|||||||Wilcoxon (Mann-Whitney)|||||||0.849
71692916|NCT03416270|142900739|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||||||0.013
71692917|NCT03416270|142900740|OTHER|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||||||0.844
71692918|NCT03416270|142900741|OTHER|||||||0.262|||||||Wilcoxon (Mann-Whitney)|||||||0.262
71692919|NCT03416270|142900742|OTHER|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||||||0.802
71692920|NCT03416270|142900743|OTHER|||||||0.327|||||||Wilcoxon (Mann-Whitney)|||||||0.327
71692921|NCT03416270|142900744|OTHER|||||||0.618|||||||Wilcoxon (Mann-Whitney)|||||||0.618
71692922|NCT03416270|142900745|OTHER|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||||||0.946
71692923|NCT03416270|142900746|OTHER|||||||0.53||||||12 week|Wilcoxon (Mann-Whitney)|||||||0.53
71692924|NCT03416270|142900746|OTHER|||||||0.89||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.89
71692925|NCT03416270|142900747|OTHER|||||||0.26||||||12 weeks|Wilcoxon (Mann-Whitney)|||||||0.26
71692926|NCT03416270|142900747|OTHER|||||||0.56||||||1 week|Wilcoxon (Mann-Whitney)|||||||0.56
71692927|NCT00928434|142900751|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent - continuous) of greater than -12.5%.|Percentage difference|1.57|||||TWO_SIDED|95.0|-0.19|3.33||||||||3.33|-0.19|
71692928|NCT00313846|142900811|SUPERIORITY_OR_OTHER|||||||0.0026|||||||Kaplan-Meier estimate mean|||||||.0026
71692929|NCT01765296|142900820|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.011|||||||ANCOVA|||The primary efficacy outcome measure is the change in the WOMAC-Pain Subscale in the index joint at Week 6 vs. pre-dose Baseline and was analyzed using a mixed effect ANCOVA. Statistical tests to determine superiority between two treatment arms, CG100649 2 mg and placebo, are two-sided, and Non-inferiority between two treatment arms, CG100649 2 mg and celecoxib 200 mg is based on a one-sided 97.5% confidence interval of the difference.||||0.011
71692930|NCT01765296|142900820|NON_INFERIORITY|"The SD for the primary efficacy outcome measure (WOMAC-Pain Subscale in the index joint) has been assumed to be 11 units. A 10% between-group difference was chosen as the non-inferiority margin for this study. The following parameters were used to calculate the sample size needed for this non-inferiority study.~* Level of significance, α = 0.025(one-sided)~* Statistical power, 1-β = 0.95~* Difference between test group and comparison group, Δ=0, δ (\>0) = non-inferiority margin"||||||0.425|||||||ANCOVA|||||||0.425
71692931|NCT03933449|142900822|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0015|TWO_SIDED|95.0|0.36|0.82||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.82|0.36|0.0015
71692932|NCT03933449|142900823|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.0008|TWO_SIDED|95.0|0.17|0.69||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.69|0.17|0.0008
71692933|NCT03933449|142900824|SUPERIORITY||Hazard Ratio (HR)|0.55||||0.0021|TWO_SIDED|95.0|0.37|0.83||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||0.83|0.37|0.0021
71692934|NCT03933449|142900825|SUPERIORITY||Difference in Percentages|12.9||||0.0084|TWO_SIDED|95.0|2.7|24.5||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||24.5|2.7|0.0084
71692935|NCT03933449|142900826|SUPERIORITY||Difference in Percentages|17.1||||0.0403|TWO_SIDED|95.0|-2.3|38.0||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||38.0|-2.3|0.0403
71692936|NCT03933449|142900827|SUPERIORITY||Difference in Percentages|13.3||||0.0083|TWO_SIDED|95.0|2.8|25.2||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %\>0.|Miettinen & Nurminen method|||||25.2|2.8|0.0083
71692937|NCT03933449|142900828|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.177|TWO_SIDED|95.0|0.58|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.58|0.177
71692938|NCT03933449|142900829|SUPERIORITY||Hazard Ratio (HR)|0.81||||0.238|TWO_SIDED|95.0|0.44|1.46||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.46|0.44|0.238
71692939|NCT03933449|142900830|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.171|TWO_SIDED|95.0|0.57|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate|||1.23|0.57|0.171
71692940|NCT03428100|142900862|SUPERIORITY||Odds Ratio (OR)|1.78||||0.071|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.071
71692941|NCT03428100|142900862|SUPERIORITY||Odds Ratio (OR)|2.15||||0.031|TWO_SIDED|95.0|1.07|4.3|||Regression, Logistic|||||4.30|1.07|0.031
71938485|NCT02295774|143397732|SUPERIORITY_OR_OTHER||Mc Nemar's χ2 test|0.0|||||TWO_SIDED|||||||Mc Nemar's χ2 test was not applicable because there is no change between visits.|Mc Nemar's χ2 test was not applicable because there is no change between visits.|"The results of the γH2AX analysis were listed and summarised by frequency tables by visit and colonic region.~The results were compared between Visit 2 and Visit 1 for each colonic region and overall using the Mc Nemar's χ2 test.~In case of the presence of at least one positive colonic region, that visit was to be considered as 'Positive' for the overall γH2AX analysis."||||
71938486|NCT01075763|143397734|SUPERIORITY_OR_OTHER|||||||0.64|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.64
71692942|NCT03428100|142900863|SUPERIORITY||Odds Ratio (OR)|1.34||||0.427|TWO_SIDED|95.0|0.65|2.77|||Regression, Logistic|||||2.77|0.65|0.427
71692943|NCT03428100|142900864|SUPERIORITY||Odds Ratio (OR)|1.35||||0.513|TWO_SIDED|95.0|0.55|3.35|||Regression, Logistic|||||3.35|0.55|0.513
71692944|NCT03428100|142900864|SUPERIORITY||Odds Ratio (OR)|1.6||||0.242|TWO_SIDED|95.0|0.73|3.53|||Regression, Logistic|||||3.53|0.73|0.242
71692945|NCT03428100|142900864|SUPERIORITY||Odds Ratio (OR)|2.54||||0.03|TWO_SIDED|95.0|1.09|5.9|||Regression, Logistic|||||5.90|1.09|0.030
71692946|NCT03428100|142900865|SUPERIORITY||Odds Ratio (OR)|1.32||||0.611|TWO_SIDED|95.0|0.45|3.83|||Regression, Logistic|||||3.83|0.45|0.611
71692947|NCT03428100|142900865|SUPERIORITY||Odds Ratio (OR)|1.59||||0.325|TWO_SIDED|95.0|0.63|3.99|||Regression, Logistic|||||3.99|0.63|0.325
71692948|NCT03428100|142900865|SUPERIORITY||Odds Ratio (OR)|2.29||||0.1|TWO_SIDED|95.0|0.85|6.14|||Regression, Logistic|||||6.14|0.85|0.100
71692949|NCT03428100|142900866|SUPERIORITY||Mean Difference (Final Values)|-17.65|STANDARD_ERROR_OF_MEAN|5.627||0.002|TWO_SIDED|95.0|-28.71|-6.58|||Mixed Models Analysis|||||-6.58|-28.71|0.002
71692950|NCT03428100|142900866|SUPERIORITY||Mean Difference (Final Values)|-13.35|STANDARD_ERROR_OF_MEAN|4.82||0.006|TWO_SIDED|95.0|-22.83|-3.87|||Mixed Models Analysis|||||-3.87|-22.83|0.006
71692951|NCT03428100|142900866|SUPERIORITY||Mean Difference (Final Values)|-20.62|STANDARD_ERROR_OF_MEAN|5.554||0.0002|TWO_SIDED|95.0|-31.54|-9.7|||Mixed Models Analysis|||||-9.70|-31.54|0.0002
71692952|NCT03428100|142900867|SUPERIORITY||Odds Ratio (OR)|4.14||||0.115|TWO_SIDED|95.0|0.71|24.29|||Regression, Logistic|||||24.29|0.71|0.115
71692953|NCT03428100|142900867|SUPERIORITY||Odds Ratio (OR)|5.85||||0.037|TWO_SIDED|95.0|1.11|30.88|||Regression, Logistic|||||30.88|1.11|0.037
71692954|NCT03428100|142900867|SUPERIORITY||Odds Ratio (OR)|4.78||||0.083|TWO_SIDED|95.0|0.81|28.08|||Regression, Logistic|||||28.08|0.81|0.083
71692955|NCT03428100|142900868|SUPERIORITY||Odds Ratio (OR)|3.28||||0.012|TWO_SIDED|95.0|1.29|8.32|||Regression, Logistic|||||8.32|1.29|0.012
71692956|NCT03428100|142900868|SUPERIORITY||Odds Ratio (OR)|3.71||||0.002|TWO_SIDED|95.0|1.59|8.66|||Regression, Logistic|||||8.66|1.59|0.002
71692957|NCT03428100|142900868|SUPERIORITY||Odds Ratio (OR)|6.85||||2e-05|TWO_SIDED|95.0|2.79|16.82|||Regression, Logistic|||||16.82|2.79|0.00002
71692958|NCT03428100|142900869|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.203||0.039|TWO_SIDED|95.0|-0.82|-0.02|||Mixed Models Analysis|||||-0.02|-0.82|0.039
71692959|NCT03428100|142900869|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.175||0.23|TWO_SIDED|95.0|-0.56|0.13|||Mixed Models Analysis|||||0.13|-0.56|0.23
71692960|NCT03428100|142900869|SUPERIORITY||Mean Difference (Final Values)|-0.79|STANDARD_ERROR_OF_MEAN|0.201||0.0001|TWO_SIDED|95.0|-1.18|-0.39|||Mixed Models Analysis|||||-0.39|-1.18|0.0001
71692961|NCT03428100|142900870|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.388||0.0714|TWO_SIDED|95.0|-1.47|0.06|||Mixed Models Analysis|||||0.06|-1.47|0.0714
71692962|NCT03428100|142900870|SUPERIORITY||Mean Difference (Final Values)|-0.84|STANDARD_ERROR_OF_MEAN|0.337||0.0134|TWO_SIDED|95.0|-1.5|-0.17|||Mixed Models Analysis|||||-0.17|-1.50|0.0134
71938487|NCT01075763|143397734|SUPERIORITY_OR_OTHER|||||||0.92|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.92
71938488|NCT01075763|143397735|SUPERIORITY_OR_OTHER|||||||0.63||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.63
71692963|NCT03428100|142900870|SUPERIORITY||Mean Difference (Final Values)|-1.45|STANDARD_ERROR_OF_MEAN|0.386||0.0002|TWO_SIDED|95.0|-2.21|-0.69|||Mixed Models Analysis|||||-0.69|-2.21|0.0002
71692964|NCT03428100|142900871|SUPERIORITY||Odds Ratio (OR)|1.71||||0.183|TWO_SIDED|95.0|0.78|3.75|||Regression, Logistic|||||3.75|0.78|0.183
71692965|NCT03428100|142900871|SUPERIORITY||Odds Ratio (OR)|1.54||||0.235|TWO_SIDED|95.0|0.76|3.11|||Regression, Logistic|||||3.11|0.76|0.235
71692966|NCT03428100|142900871|SUPERIORITY||Odds Ratio (OR)|1.01||||0.991|TWO_SIDED|95.0|0.43|2.36|||Regression, Logistic|||||2.36|0.43|0.991
71692967|NCT03428100|142900872|SUPERIORITY||Odds Ratio (OR)|1.41||||0.263|TWO_SIDED|95.0|0.77|2.57|||Regression, Logistic|||||2.57|0.77|0.263
71938489|NCT01075763|143397735|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
71938490|NCT01075763|143397736|SUPERIORITY_OR_OTHER|||||||0.45||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.45
71938491|NCT01075763|143397736|SUPERIORITY_OR_OTHER|||||||0.88||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.88
71938492|NCT01075763|143397736|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
71692968|NCT03428100|142900872|SUPERIORITY||Odds Ratio (OR)|1.89||||0.016|TWO_SIDED|95.0|1.13|3.19|||Regression, Logistic|||||3.19|1.13|0.016
71692969|NCT03428100|142900872|SUPERIORITY||Odds Ratio (OR)|1.93||||0.031|TWO_SIDED|95.0|1.06|3.52|||Regression, Logistic|||||3.52|1.06|0.031
71692970|NCT03428100|142900873|SUPERIORITY||Odds Ratio (OR)|1.97||||0.058|TWO_SIDED|95.0|0.98|3.96|||Regression, Logistic|||||3.96|0.98|0.058
71692971|NCT03428100|142900873|SUPERIORITY||Odds Ratio (OR)|1.77||||0.072|TWO_SIDED|95.0|0.95|3.32|||Regression, Logistic|||||3.32|0.95|0.072
71692972|NCT03428100|142900873|SUPERIORITY||Odds Ratio (OR)|1.56||||0.224|TWO_SIDED|95.0|0.76|3.18|||Regression, Logistic|||||3.18|0.76|0.224
71692973|NCT03428100|142900874|SUPERIORITY||Odds Ratio (OR)|5.03||||0.265|TWO_SIDED|95.0|0.29|86.08|||Regression, Logistic|||||86.08|0.29|0.265
71692974|NCT03428100|142900874|SUPERIORITY||Odds Ratio (OR)|2.54||||0.52|TWO_SIDED|95.0|0.15|43.09|||Regression, Logistic|||||43.09|0.15|0.520
71692975|NCT03428100|142900874|SUPERIORITY||Odds Ratio (OR)|7.17||||0.164|TWO_SIDED|95.0|0.45|99.99|||Regression, Logistic|||||99.99|0.45|0.164
71692976|NCT03428100|142900875|SUPERIORITY||Mean Difference (Final Values)|-6.08|STANDARD_ERROR_OF_MEAN|2.948||0.04|TWO_SIDED|95.0|-11.88|-0.29|||Mixed Models Analysis|||||-0.29|-11.88|0.040
71938493|NCT01075763|143397736|SUPERIORITY_OR_OTHER|||||||0.81||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.81
71938494|NCT01075763|143397737|SUPERIORITY_OR_OTHER|||||||0.29||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.29
71938495|NCT01075763|143397737|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.||||0.36
71938496|NCT01075763|143397737|SUPERIORITY_OR_OTHER|||||||0.68||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.68
71938497|NCT01075763|143397737|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.41
71938498|NCT01075763|143397738|SUPERIORITY_OR_OTHER|||||||0.86||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.86
71938499|NCT01075763|143397738|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.62
71938500|NCT01075763|143397738|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.21
71938501|NCT01075763|143397739|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.95
71692977|NCT03428100|142900875|SUPERIORITY||Mean Difference (Final Values)|-6.56|STANDARD_ERROR_OF_MEAN|2.533||0.01|TWO_SIDED|95.0|-11.54|-1.58|||Mixed Models Analysis|||||-1.58|-11.54|0.010
71692978|NCT03428100|142900875|SUPERIORITY||Mean Difference (Final Values)|-9.77|STANDARD_ERROR_OF_MEAN|2.919|<|0.001|TWO_SIDED|95.0|-15.51|-4.03|||Mixed Models Analysis|||||-4.03|-15.51|<0.001
71692979|NCT03428100|142900876|SUPERIORITY||Odds Ratio (OR)|4.75||||0.265|TWO_SIDED|95.0|0.31|73.93|||Regression, Logistic|||||73.93|0.31|0.265
71692980|NCT03428100|142900876|SUPERIORITY||Odds Ratio (OR)|2.5||||0.511|TWO_SIDED|95.0|0.16|38.4|||Regression, Logistic|||||38.40|0.16|0.511
71692981|NCT03428100|142900876|SUPERIORITY||Odds Ratio (OR)|4.95||||0.253|TWO_SIDED|95.0|0.32|77.11|||Regression, Logistic|||||77.11|0.32|0.253
71692982|NCT03428100|142900877|SUPERIORITY||Mean Difference (Final Values)|-6.21|STANDARD_ERROR_OF_MEAN|3.078||0.044|TWO_SIDED|95.0|-12.26|-0.16|||Mixed Models Analysis|||||-0.16|-12.26|0.044
71692983|NCT03428100|142900877|SUPERIORITY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|2.632||0.037|TWO_SIDED|95.0|-10.67|-0.32|||Mixed Models Analysis|||||-0.32|-10.67|0.037
71692984|NCT03428100|142900877|SUPERIORITY||Mean Difference (Final Values)|-8.41|STANDARD_ERROR_OF_MEAN|3.03||0.006|TWO_SIDED|95.0|-14.37|-2.45|||Mixed Models Analysis|||||-2.45|-14.37|0.006
71692985|NCT03428100|142900878|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
71692986|NCT03428100|142900878|SUPERIORITY|||||||0.797|||||||Fisher Exact|||||||0.797
71692987|NCT03428100|142900878|SUPERIORITY||||||>|0.999|||||||Fisher Exact|||||||>.999
71692988|NCT03428100|142900879|SUPERIORITY||Mean Difference (Final Values)|8.62|STANDARD_ERROR_OF_MEAN|4.49||0.056|TWO_SIDED|95.0|-0.22|17.45|||ANCOVA|||||17.45|-0.22|0.056
71692989|NCT03428100|142900879|SUPERIORITY||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.92||0.164|TWO_SIDED|95.0|-2.24|13.19|||ANCOVA|||||13.19|-2.24|0.164
71938502|NCT01075763|143397739|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.73
71938503|NCT01075763|143397739|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.30
71938504|NCT01075763|143397741|SUPERIORITY_OR_OTHER|||||||0.8||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.80
71938505|NCT01075763|143397741|SUPERIORITY_OR_OTHER|||||||0.74||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.74
71692990|NCT03428100|142900879|SUPERIORITY||Mean Difference (Final Values)|7.25|STANDARD_ERROR_OF_MEAN|4.53||0.11|TWO_SIDED|95.0|-1.66|16.15|||ANCOVA|||||16.15|-1.66|0.110
71692991|NCT03428100|142900880|SUPERIORITY||Mean Difference (Final Values)|-48.06|STANDARD_ERROR_OF_MEAN|35.63||0.178|TWO_SIDED|95.0|-118.0|21.88|||ANOVA|||||21.88|-118.00|0.178
71938506|NCT01075763|143397741|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.12
71938507|NCT01075763|143397742|SUPERIORITY_OR_OTHER|||||||0.53||95.0|||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.||||0.53
71938508|NCT01075763|143397742|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.||||0.85
71938509|NCT01075763|143397742|SUPERIORITY_OR_OTHER|||||||0.85||95.0|||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.||||0.85
71938510|NCT00586521|143397743|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was analyzed by paired t-test and Wilcoxon test (number of joint bleeds prophylaxis treatment compared to number of joint bleeds on-demand treatment) at 6 months of treatment.||||<0.001
71938511|NCT00586521|143397743|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The maximum individual reduction in the actual number of joint bleeds after the switch to prophylactic treatment was analyzed by a paired t-test of the individual difference between prophylaxis treatment bleed compared to on-demand treatment bleeds.||||<0.001
71938512|NCT00586521|143397744|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||paired t-test (prophylaxis compared to on-demand) at 6 months of treatment.||||<0.001
71938513|NCT00586521|143397745|SUPERIORITY_OR_OTHER||||||<|0.001|||||||paired t-test|||The Gilbert Score was the sum of 3 scores: pain (0=no pain to 3=severe pain); bleeding score (0=none to 3=3 or more major bleeds or 7 or more minor bleeds); and physical score (based on swelling, muscle atrophy; and axial deformity (at knee or ankle), range of motion, crepitus on motion, flexion contracture, instability.||||<0.001
71938514|NCT00586521|143397746|SUPERIORITY_OR_OTHER|||||||0.314||||||The alpha level for a significant P-value was pre-defined at 5%.|paired t-test|||"The Haemo-QoL A questionnaire measures the subject's self-assessment of disease impact on physical functioning, role functioning, worry, consequences, positive affect, and treatment concern."||||0.314
71692992|NCT03428100|142900880|SUPERIORITY||Mean Difference (Final Values)|-56.9|STANDARD_ERROR_OF_MEAN|30.9||0.066|TWO_SIDED|95.0|-117.56|3.77|||ANOVA|||||3.77|-117.56|0.066
71692993|NCT03428100|142900880|SUPERIORITY||Mean Difference (Final Values)|-71.42|STANDARD_ERROR_OF_MEAN|35.57||0.045|TWO_SIDED|95.0|-141.24|-1.6|||ANOVA|||||-1.60|-141.24|0.045
71938515|NCT02261428|143397749|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.95|||<|0.05|TWO_SIDED|95.0|1.79|8.73|||Wilcoxon (Mann-Whitney)|||||8.73|1.79|<0.05
71938516|NCT01095003|143397756|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0426|TWO_SIDED|95.0|0.71|0.99|||Log Rank|||The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms||0.99|0.71|0.0426
71938517|NCT01095003|143397757|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.7657|TWO_SIDED|95.0|0.83|1.15|||Log Rank|||||1.15|0.83|0.7657
71938518|NCT01095003|143397758|SUPERIORITY|||||||0.103|||||||Cochran-Mantel-Haenszel|||||||0.103
71938519|NCT01095003|143397759|SUPERIORITY|||||||0.0089|||||||Cochran-Mantel-Haenszel|||||||0.0089
71938520|NCT02006706|143397775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.98|STANDARD_ERROR_OF_MEAN|0.606|<|0.001|TWO_SIDED|95.0|1.73|4.22|||t-test, 2 sided||The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up|||4.22|1.73|<0.001
71938521|NCT02006706|143397776|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71938522|NCT02337933|143397803|OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71938523|NCT02337933|143397804|OTHER|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71938524|NCT02337933|143397805|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71938525|NCT02337933|143397806|OTHER|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||||||0.308
71938526|NCT02337933|143397807|OTHER|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||||||0.575
71692994|NCT03428100|142900881|SUPERIORITY||Mean Difference (Final Values)|-11.32|STANDARD_ERROR_OF_MEAN|6.62||0.088|TWO_SIDED|95.0|-24.33|1.7|||Mixed Models Analysis|||||1.70|-24.33|0.088
71692995|NCT03428100|142900881|SUPERIORITY||Mean Difference (Final Values)|-15.41|STANDARD_ERROR_OF_MEAN|5.725||0.007|TWO_SIDED|95.0|-26.67|-4.16|||Mixed Models Analysis|||||-4.16|-26.67|0.007
71692996|NCT03428100|142900881|SUPERIORITY||Mean Difference (Final Values)|-19.76|STANDARD_ERROR_OF_MEAN|6.583||0.003|TWO_SIDED|95.0|-32.71|-6.82|||Mixed Models Analysis|||||-6.82|-32.71|0.003
71938527|NCT02337933|143397808|OTHER|||||||0.169|||||||Wilcoxon (Mann-Whitney)|||||||0.169
71938528|NCT02337933|143397809|OTHER|||||||0.373|||||||Wilcoxon (Mann-Whitney)|||||||0.373
71938529|NCT02337933|143397810|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||||||0.002
71938530|NCT02337933|143397811|OTHER|||||||0.049|||||||Wilcoxon (Mann-Whitney)|||||||0.049
71938531|NCT02337933|143397812|OTHER|||||||0.224|||||||Wilcoxon (Mann-Whitney)|||||||0.224
71938532|NCT02337933|143397813|OTHER|||||||0.116|||||||Wilcoxon (Mann-Whitney)|||||||0.116
71938533|NCT02337933|143397814|OTHER|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||||||0.953
71938534|NCT02337933|143397815|OTHER|||||||0.999|||||||Wilcoxon (Mann-Whitney)|||||||0.999
71938535|NCT00992407|143397816|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.61||||0.8595|TWO_SIDED|95.0|-7.5|6.3|||t-test, 2 sided|||Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52||6.3|-7.5|0.8595
71938536|NCT00992407|143397817|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|1.29||||0.8118|TWO_SIDED|95.0|-9.6|12.2|||t-test, 2 sided|||Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52||12.2|-9.6|0.8118
71938537|NCT00992407|143397826|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|10.0||||0.1768|TWO_SIDED|95.0|-4.8|24.8|||Student's t-test|||Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52||24.8|-4.8|0.1768
71938538|NCT00992407|143397827|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.33||||0.9569|TWO_SIDED|95.0|-12.8|12.2|||Student's t-test|||||12.2|-12.8|0.9569
71938539|NCT00992407|143397828|NON_INFERIORITY_OR_EQUIVALENCE|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|0.58||||0.5294|TWO_SIDED|95.0|-5.5|2.9|||t-test, 2 sided|||||2.9|-5.5|0.5294
71938540|NCT04875065|143397838|SUPERIORITY||Mean Difference (Net)|-1.875|STANDARD_ERROR_OF_MEAN|4.804899|||TWO_SIDED|95.0|-13.23678|9.48678|||||Higher scale scores indicate greater loneliness. Thus, Mean change in total score is calculated as change = baseline intervention scores - post score, so that positive change values indicate symptom improvement.|||9.486780|-13.236780|
71938541|NCT04875065|143397839|SUPERIORITY||Median Difference (Final Values)|0.542857|STANDARD_ERROR_OF_MEAN|2.389651|||TWO_SIDED|95.0|-5.107769|6.193483|||||Higher scale scores indicate better social functioning. Thus, Mean change in total score is calculated as change = post intervention scores - baseline score, so that positive change values indicate symptom improvement.|||6.193483|-5.107769|
71938542|NCT04875065|143397840|SUPERIORITY||Mean Difference (Net)|0.5625|STANDARD_ERROR_OF_MEAN|5.176732|||TWO_SIDED|95.0|-11.678525|12.803525|||||Higher scale scores indicate better social relationship quality of life. Thus, Mean change in total score is calculated as change = post intervention scores - baseline score, so that positive change values indicate symptom improvement.|||12.803525|-11.678525|
71692997|NCT03428100|142900882|SUPERIORITY||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|7.263||0.055|TWO_SIDED|95.0|-28.28|0.28|||Mixed Models Analysis|||||0.28|-28.28|0.055
71938543|NCT00395226|143397845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.284|TWO_SIDED|95.0|-0.47|1.62||The a priori significance threshold level was 0.05 (two-sided)|ANCOVA|The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.|The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model|"The null hypothesis was no group differences. The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm."||1.62|-0.47|0.2840
71938544|NCT02456532|143397846|OTHER|analyses of variance comparing the three treatment gropus|||||=|0.05|||||||ANOVA|||||||=0.05
71938545|NCT02456532|143397847|OTHER|ANOVA|||||=|0.643|||||||ANOVA|||||||=0.643
71938546|NCT02173704|143397854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||TWO_SIDED|95.0|97.2|100.0|||Exact test of binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.||100|97.2|
71938547|NCT02173704|143397854|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%.|single binomial proportion|79.0|||||TWO_SIDED|95.0|71.4|85.8|||Exact test of binomial proportion|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.||85.8|71.4|
71938548|NCT02173704|143397856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|95.7|99.98|||Exact test of binomial proportion|||Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%.||99.98|95.7|
71938549|NCT02173704|143397856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|99.0|||||TWO_SIDED|95.0|94.7|99.82|||Exact test for binomial proportion|||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.||99.82|94.7|
71938550|NCT02173704|143397856|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|94.0|||||TWO_SIDED|95.0|88.7|97.4|||Exact test for binomial proportions|||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.||97.4|88.7|
71938551|NCT01617577|143397875|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores||||0.36
71938552|NCT01617577|143397875|SUPERIORITY_OR_OTHER|||||||0.058||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score||||0.058
71938553|NCT01617577|143397875|SUPERIORITY_OR_OTHER|||||||0.034||95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PALtot trials adj at baseline vs 14wk (final visit)||||0.034
71938554|NCT00729859|143397891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_DEVIATION|0.0075||0.28|TWO_SIDED|95.0|0.005|0.035|||paired t-test|||p value for the difference = 0.28||0.035|0.005|0.28
71938555|NCT03267264|143398008|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.5|||||TWO_SIDED|95.0|10.3|24.7||||||||24.7|10.3|
71938556|NCT03267264|143398009|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.5|||||TWO_SIDED|95.0|16.8|44.3||||||||44.3|16.8|
71938557|NCT03267264|143398009|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall|20.6|||||TWO_SIDED|95.0|4.1|37.1||||||||37.1|4.1|
71938558|NCT03267264|143398009|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|overal mean|6.2|||||TWO_SIDED|95.0|-7.2|19.5||||||||19.5|-7.2|
71692998|NCT03428100|142900882|SUPERIORITY||Mean Difference (Final Values)|-14.76|STANDARD_ERROR_OF_MEAN|6.297||0.02|TWO_SIDED|95.0|-27.15|-2.38|||Mixed Models Analysis|||||-2.38|-27.15|0.020
71938559|NCT03267264|143398009|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.8|||||TWO_SIDED|95.0|-1.1|26.7||||||||26.7|-1.1|
71938560|NCT03267264|143398010|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall mean|18.0|||||TWO_SIDED|95.0|11.3|24.7||||||Overall Comfort||24.7|11.3|
71692999|NCT03428100|142900882|SUPERIORITY||Mean Difference (Final Values)|-17.82|STANDARD_ERROR_OF_MEAN|7.216||0.014|TWO_SIDED|95.0|-32.01|-3.62|||Mixed Models Analysis|||||-3.62|-32.01|0.014
71693000|NCT03428100|142900883|SUPERIORITY||Mean Difference (Final Values)|-2.06|STANDARD_ERROR_OF_MEAN|1.229||0.095|TWO_SIDED|95.0|-4.47|-0.36|||Mixed Models Analysis|||||-0.36|-4.47|0.095
71693001|NCT03428100|142900883|SUPERIORITY||Mean Difference (Final Values)|-3.09|STANDARD_ERROR_OF_MEAN|1.057||0.004|TWO_SIDED|95.0|-5.16|-1.01|||Mixed Models Analysis|||||-1.01|-5.16|0.004
71693002|NCT03428100|142900883|SUPERIORITY||Mean Difference (Final Values)|-5.09|STANDARD_ERROR_OF_MEAN|1.216|<|0.001|TWO_SIDED|95.0|-7.48|-2.7|||Mixed Models Analysis|||||-2.70|-7.48|<0.001
71693003|NCT03428100|142900884|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.146||0.097|TWO_SIDED|95.0|-0.53|0.04|||Mixed Models Analysis|||||0.04|-0.53|0.097
71693004|NCT03428100|142900884|SUPERIORITY||Mean Difference (Final Values)|-0.27|STANDARD_ERROR_OF_MEAN|0.126||0.033|TWO_SIDED|95.0|-0.52|-0.02|||Mixed Models Analysis|||||-0.02|-0.52|0.033
71693005|NCT03428100|142900884|SUPERIORITY||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.145|<|0.001|TWO_SIDED|95.0|-0.86|-0.29|||Mixed Models Analysis|||||-0.29|-0.86|<0.001
71693006|NCT03428100|142900885|SUPERIORITY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.516||0.272|TWO_SIDED|95.0|-1.58|0.45|||Mixed Models Analysis|||Anxiety||0.45|-1.58|0.272
71693007|NCT03428100|142900885|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.446||0.013|TWO_SIDED|95.0|-1.99|-0.24|||Mixed Models Analysis|||Anxiety||-0.24|-1.99|0.013
71693008|NCT03428100|142900885|SUPERIORITY||Mean Difference (Final Values)|-0.85|STANDARD_ERROR_OF_MEAN|0.511||0.099|TWO_SIDED|95.0|-1.85|0.16|||Mixed Models Analysis|||Anxiety||0.16|-1.85|0.099
71693009|NCT03428100|142900885|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.519||0.584|TWO_SIDED|95.0|-1.3|0.74|||Mixed Models Analysis|||Depression||0.74|-1.30|0.584
71693010|NCT03428100|142900885|SUPERIORITY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.448||0.162|TWO_SIDED|95.0|-1.51|0.25|||Mixed Models Analysis|||Depression||0.25|-1.51|0.162
71938561|NCT03267264|143398010|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.9|||||TWO_SIDED|95.0|9.9|21.8||||||Anxiety Associated with a Needle Stick Injury||21.8|9.9|
71938562|NCT03267264|143398010|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.5|||||TWO_SIDED|95.0|8.9|22.1||||||Injection Pain||22.1|8.9|
71938563|NCT03267264|143398010|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.7|||||TWO_SIDED|95.0|13.8|25.7||||||Ease of Use||25.7|13.8|
71938564|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|27.8|||||TWO_SIDED|95.0|14.9|40.7||||||Overall Comfort||40.7|14.9|
71693011|NCT03428100|142900885|SUPERIORITY||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|0.515||0.024|TWO_SIDED|95.0|-2.18|-0.15|||Mixed Models Analysis|||Depression||-0.15|-2.18|0.024
71693012|NCT03428100|142900886|SUPERIORITY||Mean Difference (Final Values)|-1.23|STANDARD_ERROR_OF_MEAN|1.018||0.228|TWO_SIDED|95.0|-3.23|0.77|||Mixed Models Analysis|||||0.77|-3.23|0.228
71693013|NCT03428100|142900886|SUPERIORITY||Mean Difference (Final Values)|-1.62|STANDARD_ERROR_OF_MEAN|0.876||0.065|TWO_SIDED|95.0|-3.35|0.1|||Mixed Models Analysis|||||0.10|-3.35|0.065
71693014|NCT03428100|142900886|SUPERIORITY||Mean Difference (Final Values)|-3.01|STANDARD_ERROR_OF_MEAN|1.007||0.003|TWO_SIDED|95.0|-4.99|-1.02|||Mixed Models Analysis|||||-1.02|-4.99|0.003
71938565|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|8.9|31.6||||||Anxiety Associated with a needle stick injury||31.6|8.9|
71938566|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|16.1|||||TWO_SIDED|95.0|3.4|28.8||||||Injection Pain||28.8|3.4|
71938567|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|30.7|||||TWO_SIDED|95.0|19.3|42.1||||||Ease of Use||42.1|19.3|
71938568|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.7|||||TWO_SIDED|95.0|5.3|36.1||||||Overall Comfort||36.1|5.3|
71938569|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|19.4|||||TWO_SIDED|95.0|6.0|32.8||||||Anxiety Associated with a needle stick||32.8|6|
71938570|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.6|||||TWO_SIDED|95.0|3.6|33.7||||||Injection Pain||33.7|3.6|
71938571|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|18.4|||||TWO_SIDED|95.0|4.9|31.9||||||Ease of Use||31.9|4.9|
71938572|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|8.4|||||TWO_SIDED|95.0|-4.0|20.9||||||Overall Comfort||20.9|-4.0|
71938573|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.9|||||TWO_SIDED|95.0|1.9|23.8||||||Anxiety Associated with a Needle stick injury||23.8|1.9|
71938574|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|7.0|||||TWO_SIDED|95.0|-5.3|19.4||||||Injection Pain||19.4|-5.3|
71938575|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|17.7|||||TWO_SIDED|95.0|6.7|28.8||||||Ease of Use||28.8|6.7|
71938576|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|15.1|||||TWO_SIDED|95.0|2.1|28.1||||||Overall Comfort||28.1|2.1|
71938577|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|11.0|||||TWO_SIDED|95.0|-0.5|22.4||||||Anxiety Associated with a Needle Stick Injury||22.4|-0.5|
71938578|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||TWO_SIDED|95.0|7.4|33.1||||||Injection Pain||33.1|7.4|
71938579|NCT03267264|143398011|NON_INFERIORITY|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value \< 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is \> -10mm, we can conclude in non-inferiority.|Overall Mean|12.0|||||TWO_SIDED|95.0|0.5|23.5||||||Eae of Use||23.5|0.5|
71938580|NCT01807871|143398019|SUPERIORITY|||||||0.48|||||||Chi-squared|||||||0.48
71938581|NCT01807871|143398021|SUPERIORITY|||||||0.24|||||||Chi-squared|||Comparison of number of participants who reported removing the nicotine patch due to a side effect||||0.24
71938582|NCT03019965|143398036|SUPERIORITY||Risk Ratio (RR)|0.95||||0.156|TWO_SIDED|95.0|0.87|1.02|||Chi-squared||||The efficacy of the maneuver was evaluated by calculating the absolute risk reduction and the number needed to treat.|1.02|0.87|0.156
71938583|NCT03019965|143398037|SUPERIORITY||Risk Ratio (RR)|2.98||||0.722|TWO_SIDED|95.0|0.31|28.45|||Chi-squared|||||28.45|0.31|0.722
71938584|NCT01915732|143398038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5||||0.002|TWO_SIDED|95.0|-7.4|-1.6|||ANCOVA|||||-1.6|-7.4|0.002
71938585|NCT01915732|143398039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6|||<|0.001|TWO_SIDED|95.0|-7.3|-1.9|||ANCOVA|||||-1.9|-7.3|<0.001
71938586|NCT01915732|143398040|SUPERIORITY_OR_OTHER|||||||0.018|||||||Cochran-Mantel-Haenszel|||||||0.018
71938587|NCT01915732|143398041|SUPERIORITY_OR_OTHER|||||||0.013|||||||Cochran-Mantel-Haenszel|||||||0.013
71938588|NCT01915732|143398042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9||||0.077|TWO_SIDED|95.0|-1.8|0.1|||ANCOVA||Statistical data for the category=IL.|||0.1|-1.8|0.077
71938589|NCT01915732|143398042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.004|TWO_SIDED|95.0|-5.7|-1.1|||ANCOVA||Statistical data for the category=NIL.|||-1.1|-5.7|0.004
71938590|NCT01915732|143398043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0||||0.028|TWO_SIDED|95.0|-2.0|-0.1|||ANCOVA||Statistical data for the category=IL.|||-0.1|-2.0|0.028
71938591|NCT01915732|143398043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.002|TWO_SIDED|95.0|-5.5|-1.2|||ANCOVA||Statistical data for the category=NIL.|||-1.2|-5.5|0.002
71693015|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|-0.92|STANDARD_ERROR_OF_MEAN|3.339||0.784|TWO_SIDED|95.0|-7.5|5.67|||Mixed Models Analysis|||Change from Baseline (CFB) Absenteeism||5.67|-7.50|0.784
71693016|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|1.79|STANDARD_ERROR_OF_MEAN|2.813||0.525|TWO_SIDED|95.0|-3.75|7.34|||Mixed Models Analysis|||CFB Absenteeism||7.34|-3.75|0.525
71938592|NCT01915732|143398044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.08|TWO_SIDED|95.0|-0.06|0.0|||ANCOVA||Statistical data for the category=IL.|||0.00|-0.06|0.080
71938593|NCT01915732|143398044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.004|TWO_SIDED|95.0|-0.12|-0.02|||ANCOVA||Statistical data for the category=NIL.|||-0.02|-0.12|0.004
71938594|NCT01915732|143398044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.003|TWO_SIDED|95.0|-0.09|-0.02|||ANCOVA||Statisticial data for the category=Total.|||-0.02|-0.09|0.003
71938595|NCT01915732|143398045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.025|TWO_SIDED|95.0|-0.07|0.0|||ANCOVA||Statistical data for the category=IL.|||-0.00|-0.07|0.025
71938596|NCT01915732|143398045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|||<|0.001|TWO_SIDED|95.0|-0.14|-0.04|||ANCOVA||Statistical data for the category=NIL.|||-0.04|-0.14|<0.001
71938597|NCT01915732|143398045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07|||<|0.001|TWO_SIDED|95.0|-0.1|-0.03|||ANCOVA||Statistical data for the category=Total.|||-0.03|-0.10|<0.001
71938598|NCT01915732|143398046|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71938599|NCT01915732|143398047|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<0.001
71938600|NCT01569451|143398050|SUPERIORITY_OR_OTHER|||||||0.0493|||||||Chi-squared|||||||0.0493
71938601|NCT01569451|143398051|SUPERIORITY_OR_OTHER|||||||0.0268|||||||Peto|||||||0.0268
71938602|NCT01569451|143398052|SUPERIORITY_OR_OTHER|||||||0.0189|||||||Chi-squared|||||||0.0189
71938603|NCT01569451|143398053|SUPERIORITY_OR_OTHER|||||||0.3167|||||||Chi-squared|||||||0.3167
71938604|NCT01569451|143398054|SUPERIORITY_OR_OTHER|||||||0.094|||||||Chi-squared|||||||0.0940
71938605|NCT01569451|143398055|SUPERIORITY_OR_OTHER|||||||0.3507|||||||Fisher Exact|||||||0.3507
71938606|NCT01569451|143398056|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71938607|NCT01569451|143398057|SUPERIORITY_OR_OTHER|||||||0.4904|||||||t-test, 2 sided|||T-test||||0.4904
71938608|NCT01569451|143398058|SUPERIORITY_OR_OTHER|||||||0.4073|||||||Chi-squared|||||||0.4073
71938609|NCT01569451|143398059|SUPERIORITY_OR_OTHER|||||||0.8677|||||||Mixed Models Analysis|||||||0.8677
71938610|NCT01569451|143398060|OTHER|Mean difference between treatment groups.||||||0.3974|||||||t-test, 2 sided|||||||0.3974
71938611|NCT02114307|143398102|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71938612|NCT02114307|143398103|SUPERIORITY|||||||0.0023|||||||t-test, 2 sided|||Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0023
71938613|NCT02114307|143398103|SUPERIORITY|||||||0.0815|||||||t-test, 2 sided|||Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation||||0.0815
71938614|NCT02114307|143398104|SUPERIORITY|||||||0.127|||||||t-test, 1 sided|||||||0.127
71693017|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|3.204||0.947|TWO_SIDED|95.0|-6.11|6.53|||Mixed Models Analysis|||CFB Absenteeism||6.53|-6.11|0.947
71693018|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|3.06|STANDARD_ERROR_OF_MEAN|4.409||0.488|TWO_SIDED|95.0|-5.62|11.74|||Mixed Models Analysis|||CFB Presenteeism||11.74|-5.62|0.488
71693019|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|3.72||0.936|TWO_SIDED|95.0|-7.02|7.62|||Mixed Models Analysis|||CFB Presenteeism||7.62|-7.02|0.936
71938615|NCT02041702|143398105|SUPERIORITY|The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.|Ratio|100.0|||<|0.01|TWO_SIDED|90.0|97.6|100.0|||Clopper-Pearson|Clopper-Pearson CI for the binomial proportion|The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.|The hypothesis was: H0: P≤ 90% vs H1: P\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group||100|97.6|<0.01
71938616|NCT02041702|143398106|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-0.9||||0.0007|TWO_SIDED|90.0|-5.6|3.8|||Farrington-Manning Test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\>-10%~* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit"||3.8|-5.6|0.0007
71938617|NCT02041702|143398107|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-1.7||||0.0012|TWO_SIDED|90.0|-6.2|2.8|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||2.8|-6.2|0.0012
71693020|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|4.267||0.991|TWO_SIDED|95.0|-8.35|8.45|||Mixed Models Analysis|||CFB Presenteeism||8.45|-8.35|0.991
71693021|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|1.15|STANDARD_ERROR_OF_MEAN|4.938||0.816|TWO_SIDED|95.0|-8.57|10.88|||Mixed Models Analysis|||CFB Work Productivity Loss||10.88|-8.57|0.816
71938618|NCT02041702|143398108|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-2.7||||0.0446|TWO_SIDED|90.0|-9.8|4.3|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||4.3|-9.8|0.0446
71938619|NCT02041702|143398109|NON_INFERIORITY|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|2.6||||0.0002|TWO_SIDED|90.0|-3.2|8.4|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \>-10%~* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"||8.4|-3.2|0.0002
71693022|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|4.178||0.971|TWO_SIDED|95.0|-8.08|8.38|||Mixed Models Analysis|||CFB Work Productivity Loss||8.38|-8.08|0.971
71693023|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|4.804||0.852|TWO_SIDED|95.0|-10.36|8.56|||Mixed Models Analysis|||CFB Work Productivity Loss||8.56|-10.36|0.852
71693024|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|-1.99|STANDARD_ERROR_OF_MEAN|3.877||0.607|TWO_SIDED|95.0|-9.61|5.63|||Mixed Models Analysis|||CFB Activity Impairment||5.63|-9.61|0.607
71693025|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|3.319||0.186|TWO_SIDED|95.0|-10.92|2.12|||Mixed Models Analysis|||CFB Activity Impairment||2.12|-10.92|0.186
71693026|NCT03428100|142900887|SUPERIORITY||Mean Difference (Final Values)|-7.45|STANDARD_ERROR_OF_MEAN|3.82||0.052|TWO_SIDED|95.0|-14.96|0.06|||Mixed Models Analysis|||CFB Activity Impairment||0.06|-14.96|0.052
71693027|NCT03428100|142900888|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.022||0.131|TWO_SIDED|95.0|-0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|-0.01|0.131
71693028|NCT03428100|142900888|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.019||0.017|TWO_SIDED|95.0|0.01|0.08|||Mixed Models Analysis|||CFB US Health State Index||0.08|0.01|0.017
71938620|NCT03977584|143398117|SUPERIORITY||Difference in Annualized Rate of Change|-0.013|STANDARD_ERROR_OF_MEAN|0.00993||0.1953|TWO_SIDED|95.0|-0.0327|0.0068|||RCRM|||Analysis was based on RCRM using unstructured covariance matrix: GTP1 PET = Treatment \* Analysis Year + Interactive Voice or Web Response System (IxRS) defined Age Group + IxRS defined Education History + IxRS defined apolipoprotein (APOE4) Carrier Status + IxRS defined Clinical Dementia Rating Global Score.||0.0068|-0.0327|0.1953
71938621|NCT00458302|143398118|NON_INFERIORITY_OR_EQUIVALENCE|The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.6|||||TWO_SIDED|95.0|-10.1|6.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.||6.8|-10.1|
71938622|NCT00458302|143398119|NON_INFERIORITY_OR_EQUIVALENCE|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.0|||||TWO_SIDED|95.0|-9.9|7.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.||7.8|-9.9|
71938623|NCT00458302|143398121|SUPERIORITY_OR_OTHER||Difference in proportion of response|1.29|||||TWO_SIDED|95.0|-7.99|10.58|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|||10.58|-7.99|
71938624|NCT02146430|143398151|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.187||0.187|TWO_SIDED|95.0|-0.61|0.12|||Difference of means|||||0.12|-0.61|0.1870
71938625|NCT02146430|143398151|SUPERIORITY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.185||0.0944|TWO_SIDED|95.0|-0.67|0.05|||Difference of means|||||0.05|-0.67|0.0944
71938626|NCT02146430|143398151|SUPERIORITY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.187||0.1391|TWO_SIDED|95.0|-0.64|0.09|||Difference of means|||||0.09|-0.64|0.1391
71938627|NCT02146430|143398151|SUPERIORITY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.187||0.7338|TWO_SIDED|95.0|-0.43|0.3|||Difference of means|||||0.30|-0.43|0.7338
71938628|NCT02146430|143398151|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.19||0.8705|TWO_SIDED|95.0|-0.4|0.34|||Difference of means|||||0.34|-0.40|0.8705
71938629|NCT02146430|143398153|SUPERIORITY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|1.592||0.0326|TWO_SIDED|95.0|-6.52|-0.28|||Difference of means|||||-0.28|-6.52|0.0326
71938630|NCT02146430|143398153|SUPERIORITY||Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|1.592||0.422|TWO_SIDED|95.0|-4.4|1.84|||Difference of means|||||1.84|-4.40|0.4220
71938631|NCT02146430|143398153|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|1.615||0.9659|TWO_SIDED|95.0|-3.1|3.23|||Difference of means|||||3.23|-3.10|0.9659
71938632|NCT02146430|143398153|SUPERIORITY||Mean Difference (Final Values)|2.12|STANDARD_ERROR_OF_MEAN|1.608||0.1867|TWO_SIDED|95.0|-1.03|5.28|||Difference of means|||||5.28|-1.03|0.1867
71938633|NCT02146430|143398153|SUPERIORITY||Mean Difference (Final Values)|3.47|STANDARD_ERROR_OF_MEAN|1.631||0.0333|TWO_SIDED|95.0|0.27|6.67|||Difference of means|||||6.67|0.27|0.0333
71938634|NCT02146430|143398155|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.2474|TWO_SIDED|95.0|-0.9|0.2|||ANCOVA|||||0.2|-0.9|0.2474
71938635|NCT02146430|143398155|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.28||0.3347|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||||0.3|-0.8|0.3347
71938636|NCT02146430|143398155|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.3999|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||||0.8|-0.3|0.3999
71693029|NCT03428100|142900888|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.003|TWO_SIDED|95.0|0.02|0.11|||Mixed Models Analysis|||CFB US Health State Index||0.11|0.02|0.003
71938637|NCT02146430|143398155|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.28||0.8435|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||||0.6|-0.5|0.8435
71938638|NCT02146430|143398155|SUPERIORITY||Difference in least squares means|0.6|STANDARD_ERROR_OF_MEAN|0.28||0.0446|TWO_SIDED|95.0|0.0|1.1|||ANCOVA|||||1.1|0.0|0.0446
71938639|NCT02146430|143398156|SUPERIORITY||Difference of least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.24||0.9775|TWO_SIDED|95.0|-0.5|0.5|||ANCOVA|||Anxiety: Placebo vs Pregabalin 150 mg BID||0.5|-0.5|0.9775
71938640|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.65|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg QD||0.4|-0.6|0.6500
71938641|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6546|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Placebo vs DS-5565 15 mg BID||0.4|-0.6|0.6546
71938642|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6692|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.6|0.6692
71938643|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.24||0.6737|TWO_SIDED|95.0|-0.6|0.4|||ANCOVA|||Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.6|0.6737
71938644|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.27||0.3888|TWO_SIDED|95.0|-0.8|0.3|||ANCOVA|||Depression: Placebo vs Pregabalin 150 mg BID||0.3|-0.8|0.3888
71938645|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.27||0.92|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg QD||0.6|-0.5|0.9200
71938646|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.27||0.7061|TWO_SIDED|95.0|-0.4|0.6|||ANCOVA|||Depression: Placebo vs DS-5565 15 mg BID||0.6|-0.4|0.7061
71938647|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.3337|TWO_SIDED|95.0|-0.3|0.8|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.3|0.3337
71938648|NCT02146430|143398156|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.27||0.2139|TWO_SIDED|95.0|-0.2|0.9|||ANCOVA|||Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.9|-0.2|0.2139
71938649|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|2.197|STANDARD_ERROR_OF_MEAN|1.4933||0.1416|TWO_SIDED|95.0|-0.733|5.126|||ANCOVA|||Physical Component: Placebo vs Pregabalin 150 mg BID||5.126|-0.733|0.1416
71938650|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|0.249|STANDARD_ERROR_OF_MEAN|1.492||0.8677|TWO_SIDED|95.0|-2.679|3.176|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg QD||3.176|-2.679|0.8677
71938651|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-0.899|STANDARD_ERROR_OF_MEAN|1.4959||0.5481|TWO_SIDED|95.0|-3.834|2.036|||ANCOVA|||Physical Component: Placebo vs DS-5565 15 mg BID||2.036|-3.834|0.5481
71938652|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-1.948|STANDARD_ERROR_OF_MEAN|1.4875||0.1906|TWO_SIDED|95.0|-4.866|0.971|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.971|-4.866|0.1906
71938653|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-3.095|STANDARD_ERROR_OF_MEAN|1.4883||0.0378|TWO_SIDED|95.0|-6.015|-0.175|||ANCOVA|||Physical Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||-0.175|-6.015|0.0378
71938654|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|0.664|STANDARD_ERROR_OF_MEAN|0.6865||0.3337|TWO_SIDED|95.0|-0.683|2.011|||ANCOVA|||Mental Component: Placebo vs Pregabalin 150 mg BID||2.011|-0.683|0.3337
71938655|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-0.194|STANDARD_ERROR_OF_MEAN|0.686||0.7778|TWO_SIDED|95.0|-1.54|1.152|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg QD||1.152|-1.540|0.7778
71938656|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-0.087|STANDARD_ERROR_OF_MEAN|0.6879||0.8991|TWO_SIDED|95.0|-1.437|1.262|||ANCOVA|||Mental Component: Placebo vs DS-5565 15 mg BID||1.262|-1.437|0.8991
71938657|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-0.857|STANDARD_ERROR_OF_MEAN|0.6833||0.2098|TWO_SIDED|95.0|-2.198|0.483|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.483|-2.198|0.2098
71938658|NCT02146430|143398157|SUPERIORITY||Difference in least squares means|-0.751|STANDARD_ERROR_OF_MEAN|0.6842||0.2725|TWO_SIDED|95.0|-2.093|0.591|||ANCOVA|||Mental Component: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.591|-2.093|0.2725
71938659|NCT02146430|143398158|SUPERIORITY||Difference in least squares means|0.0018|STANDARD_ERROR_OF_MEAN|0.01329||0.8923|TWO_SIDED|95.0|-0.0243|0.0279|||ANCOVA|||||0.0279|-0.0243|0.8923
71938660|NCT02146430|143398158|SUPERIORITY||Difference in least squares means|-0.0021|STANDARD_ERROR_OF_MEAN|0.01327||0.8749|TWO_SIDED|95.0|-0.0281|0.024|||ANCOVA|||||0.0240|-0.0281|0.8749
71938661|NCT02146430|143398158|SUPERIORITY||Difference in least squares means|-0.0091|STANDARD_ERROR_OF_MEAN|0.01332||0.4932|TWO_SIDED|95.0|-0.0353|0.017|||ANCOVA|||||0.0170|-0.0353|0.4932
71938662|NCT02146430|143398158|SUPERIORITY||Difference in least squares means|-0.0039|STANDARD_ERROR_OF_MEAN|0.01323||0.7688|TWO_SIDED|95.0|-0.0298|0.0221|||ANCOVA|||||0.0221|-0.0298|0.7688
71938663|NCT02146430|143398158|SUPERIORITY||Difference in least squares means|-0.0109|STANDARD_ERROR_OF_MEAN|0.01326||0.4099|TWO_SIDED|95.0|-0.0369|0.0151|||ANCOVA|||||0.0151|-0.0369|0.4099
71938664|NCT02146430|143398159|SUPERIORITY||Difference in least squares means|-0.55|STANDARD_ERROR_OF_MEAN|0.166||0.0009|TWO_SIDED|95.0|-0.88|-0.23|||Mixed Models Analysis|||||-0.23|-0.88|0.0009
71938665|NCT02146430|143398159|SUPERIORITY||Difference in least squares means|-0.63|STANDARD_ERROR_OF_MEAN|0.166||0.0001|TWO_SIDED|95.0|-0.96|-0.31|||Mixed Models Analysis|||||-0.31|-0.96|0.0001
71938666|NCT02146430|143398159|SUPERIORITY||Difference in least squares means|-0.85|STANDARD_ERROR_OF_MEAN|0.167|<|0.0001|TWO_SIDED|95.0|-1.17|-0.52|||Mixed Models Analysis|||||-0.52|-1.17|<0.0001
71938667|NCT02146430|143398159|SUPERIORITY||Difference in least squares means|-0.08|STANDARD_ERROR_OF_MEAN|0.167||0.6408|TWO_SIDED|95.0|-0.4|0.25|||Mixed Models Analysis|||||0.25|-0.40|0.6408
71938668|NCT02146430|143398159|SUPERIORITY||Difference in least squares means|-0.29|STANDARD_ERROR_OF_MEAN|0.167||0.0786|TWO_SIDED|95.0|-0.62|0.03|||Mixed Models Analysis|||||0.03|-0.62|0.0786
71938669|NCT02146430|143398161|SUPERIORITY||Difference of least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0541|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||Worst pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.7|0.0541
71938670|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.7771|TWO_SIDED|95.0|-0.4|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg QD||0.3|-0.4|0.7771
71938671|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.19||0.5488|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Worst pain: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.5488
71938672|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.19||0.0987|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0987
71938673|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.184|TWO_SIDED|95.0|-0.1|0.6|||ANCOVA|||Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.1|0.1840
71938674|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.18||0.1903|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|||Least pain: Placebo vs Pregabalin 150 mg BID||0.1|-0.6|0.1903
71938675|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5787|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg QD||0.2|-0.4|0.5787
71938676|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.5535|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Least pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.5535
71938677|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4476|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.2|0.4476
71938678|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4737|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.4737
71938679|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0814|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Average pain: Placebo vs Pregabalin 150 mg BID||0.0|-0.6|0.0814
71938680|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.3069|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg QD||0.2|-0.5|0.3069
71938681|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3916|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|||Average pain: Placebo vs DS-5565 15 mg BID||0.2|-0.5|0.3916
71938682|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.4667|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.4|-0.2|0.4667
71938683|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.3744|TWO_SIDED|95.0|-0.2|0.5|||ANCOVA|||Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.2|0.3744
71938684|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2959|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Pain right now: Placebo vs Pregabalin 150 mg BID||0.2|-0.6|0.2959
71693030|NCT03428100|142900888|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.031||0.102|TWO_SIDED|95.0|-0.01|0.11|||Mixed Models Analysis|||CFB UK Health State Index||0.11|-0.01|0.102
71693031|NCT03428100|142900888|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.027||0.014|TWO_SIDED|95.0|0.01|0.12|||Mixed Models Analysis|||CFB UK Health State Index||0.12|0.01|0.014
71693032|NCT03428100|142900888|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.031||0.003|TWO_SIDED|95.0|0.03|0.15|||Mixed Models Analysis|||CFB UK Health State Index||0.15|0.03|0.003
71693033|NCT03428100|142900889|SUPERIORITY||Mean Difference (Final Values)|3.99|STANDARD_ERROR_OF_MEAN|3.256||0.221|TWO_SIDED|95.0|-2.41|10.39|||Mixed Models Analysis|||||10.39|-2.41|0.221
71693034|NCT03428100|142900889|SUPERIORITY||Mean Difference (Final Values)|1.12|STANDARD_ERROR_OF_MEAN|2.807||0.689|TWO_SIDED|95.0|-4.4|6.65|||Mixed Models Analysis|||||6.65|-4.40|0.689
71693035|NCT03428100|142900889|SUPERIORITY||Mean Difference (Final Values)|3.39|STANDARD_ERROR_OF_MEAN|3.226||0.294|TWO_SIDED|95.0|-2.95|9.74|||Mixed Models Analysis|||||9.74|-2.95|0.294
71693036|NCT03428100|142900890|SUPERIORITY||Odds Ratio (OR)|1.33||||0.382|TWO_SIDED|95.0|0.7|2.54|||Regression, Logistic|||||2.54|0.70|0.382
71693037|NCT03428100|142900890|SUPERIORITY||Odds Ratio (OR)|1.15||||0.638|TWO_SIDED|95.0|0.65|2.02|||Regression, Logistic|||||2.02|0.65|0.638
71693038|NCT03428100|142900890|SUPERIORITY||Odds Ratio (OR)|1.56||||0.169|TWO_SIDED|95.0|0.83|2.96|||Regression, Logistic|||||2.96|0.83|0.169
71693039|NCT03428100|142900891|SUPERIORITY||LS Mean Difference (Final Values)|-7.36|STANDARD_ERROR_OF_MEAN|9.674||0.447|TWO_SIDED|95.0|-26.38|11.66|||Regression, Linear|||||11.66|-26.38|0.447
71693040|NCT03428100|142900891|SUPERIORITY||LS Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|8.454||0.646|TWO_SIDED|95.0|-20.5|12.74|||Regression, Linear|||||12.74|-20.50|0.646
71693041|NCT03428100|142900891|SUPERIORITY||LS Mean Difference (Final Values)|-17.18|STANDARD_ERROR_OF_MEAN|9.64||0.075|TWO_SIDED|95.0|-36.14|1.77|||Regression, Linear|||||1.77|-36.14|0.075
71693042|NCT04556760|142900909|OTHER||Mean Difference (Final Values)|-132.9528||||0.036|TWO_SIDED|95.0|-256.5082|-9.3973|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-9.3973|-256.5082|0.036
71693043|NCT04556760|142900909|OTHER||Mean Difference (Final Values)|-142.033||||0.432|TWO_SIDED|95.0|-554.8722|270.8061|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||270.8061|-554.8722|0.432
71693044|NCT04556760|142900909|OTHER||Mean Difference (Final Values)|-126.8829||||0.03|TWO_SIDED|95.0|-236.0426|-17.7233|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||-17.7233|-236.0426|0.030
71693045|NCT04556760|142900910|OTHER||Mean Difference (Final Values)|-1.5067|||<|0.001|TWO_SIDED|95.0|-2.082|-0.9314|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-0.9314|-2.0820|<0.001
71693046|NCT04556760|142900910|OTHER||Mean Difference (Final Values)|-1.1099|||<|0.001|TWO_SIDED|95.0|-1.7257|-0.4941|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||-0.4941|-1.7257|<0.001
71693047|NCT04556760|142900910|OTHER||Mean Difference (Final Values)|-0.1601||||0.547||95.0|-0.693|0.3729|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3729|-0.6930|0.547
71693048|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-1.5015|||<|0.001|TWO_SIDED|95.0|-2.2258|-0.7773|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[00 to 24 h\])||-0.7773|-2.2258|<0.001
71693049|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-1.8643|||<|0.001||95.0|-2.5611|-1.1674|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[24 to 48 h\])||-1.1674|-2.5611|<0.001
71693050|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-1.5998|||<|0.001|TWO_SIDED|95.0|-2.3025|-0.8971|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg \[48 to 72 h\])||-0.8971|-2.3025|<0.001
71693051|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-0.8474||||0.013|TWO_SIDED|95.0|-1.4465|-0.2484|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[00 to 24 h\])||-0.2484|-1.4465|0.013
71693052|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-0.7778||||0.061|TWO_SIDED|95.0|-1.6022|0.0466|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[24 to 48 h\])||0.0466|-1.6022|0.061
71693053|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-1.143||||0.003|TWO_SIDED|95.0|-1.7622|-0.5238|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg \[48 to 72 h\])||-0.5238|-1.7622|0.003
71693054|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-0.36||||0.125|TWO_SIDED|95.0|-0.8338|0.1138|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[00 to 24 h\])||0.1138|-0.8338|0.125
71693055|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-0.0845||||0.84|TWO_SIDED|95.0|-0.9706|0.8016|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[24 to 48 h\])||0.8016|-0.9706|0.840
71693056|NCT04556760|142900911|OTHER||Mean Difference (Final Values)|-0.1298||||0.571|TWO_SIDED|95.0|-0.646|0.3864|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5 mg \[48 to 72 h\])||0.3864|-0.6460|0.571
71693057|NCT04556760|142900912|OTHER||Mean Difference (Final Values)|-0.07||||0.753|TWO_SIDED|95.0|-0.55|0.4|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.40|-0.55|0.753
71693058|NCT04556760|142900912|OTHER||Mean Difference (Final Values)|-0.04||||0.802|TWO_SIDED|95.0|-0.46|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.37|-0.46|0.802
71938685|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9119|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9119
71938686|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.19||0.9399|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Pain right now: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.9399
71938687|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2455|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.2455
71938688|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.2|STANDARD_ERROR_OF_MEAN|0.19||0.3311|TWO_SIDED|95.0|-0.2|0.6|||ANCOVA|||Pain right now: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.6|-0.2|0.3311
71938689|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.254|STANDARD_ERROR_OF_MEAN|0.1647||0.1233|TWO_SIDED|95.0|-0.577|0.069|||ANCOVA|||Severity score: Placebo vs Pregabalin 150 mg BID||0.069|-0.577|0.1233
71938690|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.072|STANDARD_ERROR_OF_MEAN|0.1643||0.661|TWO_SIDED|95.0|-0.394|0.25|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg QD||0.250|-0.394|0.6610
71938691|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.098|STANDARD_ERROR_OF_MEAN|0.1649||0.5514|TWO_SIDED|95.0|-0.422|0.225|||ANCOVA|||Severity score: Placebo vs DS-5565 15 mg BID||0.225|-0.422|0.5514
71938692|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.182|STANDARD_ERROR_OF_MEAN|0.1638||0.2673|TWO_SIDED|95.0|-0.14|0.503|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.503|-0.140|0.2673
71938693|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.156|STANDARD_ERROR_OF_MEAN|0.1644||0.3439|TWO_SIDED|95.0|-0.167|0.478|||ANCOVA|||Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.478|-0.167|0.3439
71938694|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|2.6|STANDARD_ERROR_OF_MEAN|2.4||0.2708|TWO_SIDED|95.0|-2.1|7.4|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs Pregabalin 150 mg BID||7.4|-2.1|0.2708
71938695|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|1.2|STANDARD_ERROR_OF_MEAN|2.4||0.6285|TWO_SIDED|95.0|-3.5|5.9|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 15 mg QD||5.9|-3.5|0.6285
71938696|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|2.41||0.9177|TWO_SIDED|95.0|-5.0|4.5|||ANCOVA|||Relief (%) by treatment of pain: Placebo vs DS-5565 150 mg BID||4.5|-5.0|0.9177
71938697|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-1.5|STANDARD_ERROR_OF_MEAN|2.38||0.5334|TWO_SIDED|95.0|-6.2|3.2|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD||3.2|-6.2|0.5334
71938698|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-2.9|STANDARD_ERROR_OF_MEAN|2.39||0.2261|TWO_SIDED|95.0|-7.6|1.8|||ANCOVA|||Relief (%) by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID||1.8|-7.6|0.2261
71938699|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-3.87|STANDARD_ERROR_OF_MEAN|1.758||0.0281|TWO_SIDED|95.0|-7.32|-0.42|||ANCOVA|||Interference: Placebo vs Pregabalin 150 mg BID||-0.42|-7.32|0.0281
71938700|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-1.42|STANDARD_ERROR_OF_MEAN|1.756||0.419|TWO_SIDED|95.0|-4.87|2.03|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg QD||2.03|-4.87|0.4190
71693059|NCT04556760|142900912|OTHER||Mean Difference (Final Values)|0.0||||0.985|TWO_SIDED|95.0|-0.37|0.37|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.37|-0.37|0.985
71693060|NCT04556760|142900913|OTHER||Mean Difference (Final Values)|20498.7|||<|0.001|TWO_SIDED|95.0|10819.2|30178.2|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||30178.2|10819.2|<0.001
71693061|NCT04556760|142900913|OTHER||Mean Difference (Final Values)|3321.4||||0.659|TWO_SIDED|95.0|-12975.8|19618.6|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||19618.6|-12975.8|0.659
71693062|NCT04556760|142900913|OTHER||Mean Difference (Final Values)|-2698.8||||0.521|TWO_SIDED|95.0|-14849.0|9451.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9451.3|-14849.0|0.521
71938701|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-1.61|STANDARD_ERROR_OF_MEAN|1.763||0.3622|TWO_SIDED|95.0|-5.06|1.85|||ANCOVA|||Interference: Placebo vs DS-5565 15 mg BID||1.85|-5.06|0.3622
71938702|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|2.45|STANDARD_ERROR_OF_MEAN|1.75||0.1623|TWO_SIDED|95.0|-0.99|5.88|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD||5.88|-0.99|0.1623
71938703|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|2.26|STANDARD_ERROR_OF_MEAN|1.753||0.1978|TWO_SIDED|95.0|-1.18|5.7|||ANCOVA|||Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID||5.70|-1.18|0.1978
71938704|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0867|TWO_SIDED|95.0|-0.8|0.1|||ANCOVA|||General activity: Placebo vs Pregabalin 150 mg BID||0.1|-0.8|0.0867
71938705|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.6993
71938706|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8702|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||General activity: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8702
71938707|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1826|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.1826
71938708|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1206|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1206
71938709|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.21||0.0211|TWO_SIDED|95.0|-0.9|-0.1|||ANCOVA|||Mood: Placebo vs Pregabalin 150 mg BID||-0.1|-0.9|0.0211
71938710|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.4963|TWO_SIDED|95.0|-0.6|0.3|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg QD||0.3|-0.6|0.4963
71938711|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.3031|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Mood: Placebo vs DS-5565 15 mg BID||0.2|-0.6|0.3031
71938712|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1019|TWO_SIDED|95.0|-0.1|0.8|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.1|0.1019
71938713|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.201|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.2010
71693063|NCT04556760|142900914|OTHER||Mean Difference (Final Values)|-1002.5864||||0.003|TWO_SIDED|95.0|-1620.215|-384.9577|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-384.9577|-1620.2150|0.003
71693064|NCT04556760|142900914|OTHER||Mean Difference (Final Values)|40.9836||||0.865|TWO_SIDED|95.0|-526.6968|608.664|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||608.6640|-526.6968|0.865
71693065|NCT04556760|142900914|OTHER||Mean Difference (Final Values)|101.4137||||0.754|TWO_SIDED|95.0|-628.8097|831.637|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||831.6370|-628.8097|0.754
71938714|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0331|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Walking ability: Placebo vs Pregabalin 150 mg BID||-0.0|-0.9|0.0331
71938715|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.7478|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg QD||0.3|-0.5|0.7478
71938716|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.1|STANDARD_ERROR_OF_MEAN|0.21||0.694|TWO_SIDED|95.0|-0.5|0.3|||ANCOVA|||Walking ability: Placebo vs DS-5565 15 mg BID||0.3|-0.5|0.6940
71938717|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.069|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.8|-0.0|0.0690
71938718|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0816|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0816
71938719|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1174|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Normal work: Placebo vs Pregabalin 150 mg BID||0.1|-0.7|0.1174
71938720|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.925|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9250
71693066|NCT04556760|142900915|OTHER||Mean Difference (Final Values)|-1225.905||||0.004|TWO_SIDED|95.0|-2007.2241|-444.5859|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||-444.5859|-2007.2241|0.004
71693067|NCT04556760|142900915|OTHER||Mean Difference (Final Values)|-466.9802||||0.313|TWO_SIDED|95.0|-1521.5088|587.5485|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||587.5485|-1521.5088|0.313
71693068|NCT04556760|142900915|OTHER||Mean Difference (Final Values)|-375.3161||||0.404||95.0|-1433.6265|682.9943|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||682.9943|-1433.6265|0.404
71693069|NCT04556760|142900916|OTHER||Mean Difference (Final Values)|365.6323||||0.608|TWO_SIDED|95.0|-1097.7973|1829.0618|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1829.0618|-1097.7973|0.608
71938721|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.8555|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Normal work: Placebo vs DS-5565 15 mg BID||0.4|-0.4|0.8555
71938722|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.0956|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.1|0.0956
71938723|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1659|TWO_SIDED|95.0|-0.1|0.7|||ANCOVA|||Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.7|-0.1|0.1659
71938724|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0468|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs Pregabalin 150 mg BID||-0.0|-0.8|0.0468
71938725|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.3|STANDARD_ERROR_OF_MEAN|0.21||0.1083|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg QD||0.1|-0.7|0.1083
71938726|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.21||0.0505|TWO_SIDED|95.0|-0.8|0.0|||ANCOVA|||Relations with other people: Placebo vs DS-5565 15 mg BID||0.0|-0.8|0.0505
71938727|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.21||0.6993|TWO_SIDED|95.0|-0.3|0.5|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.5|-0.3|0.6993
71938728|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.21||0.9781|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.4|-0.4|0.9781
71693070|NCT04556760|142900916|OTHER||Mean Difference (Final Values)|188.236||||0.897|TWO_SIDED|95.0|-3214.3323|3590.8043|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3590.8043|-3214.3323|0.897
71693071|NCT04556760|142900916|OTHER||Mean Difference (Final Values)|-1061.4494||||0.381||95.0|-3588.2233|1465.3244|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||1465.3244|-3588.2233|0.381
71693072|NCT04556760|142900917|OTHER||Mean Difference (Final Values)|60.4211|||<|0.001||95.0|29.4904|91.3518|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||91.3518|29.4904|<0.001
71693073|NCT04556760|142900917|OTHER||Mean Difference (Final Values)|26.4529||||0.432||95.0|-44.9414|97.8471|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||97.8471|-44.9414|0.432
71693074|NCT04556760|142900917|OTHER||Mean Difference (Final Values)|-24.0243||||0.282||95.0|-74.0731|26.0245|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||26.0245|-74.0731|0.282
71693075|NCT04556760|142900918|OTHER||Mean Difference (Final Values)|-0.6023||||0.531|TWO_SIDED|95.0|-2.5463|1.3416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||1.3416|-2.5463|0.531
71693076|NCT04556760|142900918|OTHER||Mean Difference (Final Values)|0.4621||||0.682|TWO_SIDED|95.0|-2.0933|3.0176|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||3.0176|-2.0933|0.682
71693077|NCT04556760|142900919|OTHER||Mean Difference (Final Values)|0.0679||||0.526||95.0|-0.152|0.2866|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.2866|-0.1520|0.526
71938729|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.6|STANDARD_ERROR_OF_MEAN|0.23||0.0154|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs Pregabalin 150 mg BID||-0.1|-1.0|0.0154
71693078|NCT04556760|142900919|OTHER||Mean Difference (Final Values)|0.0882||||0.569||95.0|-0.2653|0.4416|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg||0.4416|-0.2653|0.569
71693079|NCT04556760|142900919|OTHER||Mean Difference (Final Values)|0.1257||||0.166|TWO_SIDED|95.0|-0.0677|0.3191|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.3191|-0.0677|0.166
71693080|NCT04556760|142900920|OTHER||Mean Difference (Final Values)|0.01||||0.226|TWO_SIDED|95.0|-0.0072|0.0271|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0271|-0.0072|0.226
71693081|NCT04556760|142900920|OTHER||Mean Difference (Final Values)|0.0033||||0.619||95.0|-0.0128|0.0195|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0195|-0.0128|0.619
71693082|NCT04556760|142900920|OTHER||Mean Difference (Final Values)|0.0009||||0.917||95.0|-0.0189|0.0207|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0207|-0.0189|0.917
71693083|NCT04556760|142900921|OTHER||Mean Difference (Final Values)|0.0007||||0.357|TWO_SIDED|95.0|-0.0008|0.0022|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.0022|-0.0008|0.357
71693084|NCT04556760|142900921|OTHER||Mean Difference (Final Values)|0.0003||||0.676|TWO_SIDED|95.0|-0.0012|0.0017|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||0.0017|-0.0012|0.676
71693085|NCT04556760|142900921|OTHER||Mean Difference (Final Values)|0.0012||||0.096||95.0|-0.0002|0.0026|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||0.0026|-0.0002|0.096
71693086|NCT04556760|142900922|OTHER||Mean Difference (Final Values)|-1.73||||0.646|TWO_SIDED|95.0|-9.4|5.95|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||5.95|-9.40|0.646
71693087|NCT04556760|142900922|OTHER||Mean Difference (Final Values)|-10.97||||0.11||95.0|-25.39|3.44|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||3.44|-25.39|0.110
71693088|NCT04556760|142900922|OTHER||Mean Difference (Final Values)|-0.35||||0.932||95.0|-10.32|9.61|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||9.61|-10.32|0.932
71693089|NCT04556760|142900923|OTHER||Mean Difference (Final Values)|7.6||||0.533|TWO_SIDED|95.0|-17.4|32.7|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||32.7|-17.4|0.533
71693090|NCT04556760|142900923|OTHER||Mean Difference (Final Values)|22.3||||0.311||95.0|-26.7|71.3|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||71.3|-26.7|0.311
71693091|NCT04556760|142900923|OTHER||Mean Difference (Final Values)|31.0||||0.204||95.0|-21.9|83.9|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||83.9|-21.9|0.204
71693092|NCT04556760|142900933|OTHER||Mean Difference (Final Values)|-4.0066||||0.103|TWO_SIDED|95.0|-8.888|0.8748|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 72mg vs Prednisolone 40mg)||0.8748|-8.8880|0.103
71693093|NCT04556760|142900933|OTHER||Mean Difference (Final Values)|5.7535||||0.005||95.0|2.6034|8.9036|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (AZD9567 40mg vs Prednisolone 20mg)||8.9036|2.6034|0.005
71693094|NCT04556760|142900933|OTHER||Mean Difference (Final Values)|9.0619||||0.023||95.0|1.674|16.4499|||Mixed Models Analysis|||Pairwise Comparisons with Prednisolone (Placebo vs Prednisolone 5mg)||16.4499|1.6740|0.023
71693095|NCT02038179|142900943|SUPERIORITY|||||||0.83||||||Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.|paired t-test|||||||0.83
71693096|NCT02038179|142900944|SUPERIORITY||||||<|0.001|||||||paired t-test|||||||<0.001
71693097|NCT02038179|142900945|SUPERIORITY|||||||0.84|||||||paired t-test|||||||0.84
71693098|NCT02221648|142900946|SUPERIORITY_OR_OTHER|||||||0.447|||||||Fisher Exact|||||||0.4470
71693099|NCT02221648|142900947|SUPERIORITY_OR_OTHER|||||||0.0293|||||||Fisher Exact|||||||0.0293
71693100|NCT02221648|142900948|SUPERIORITY_OR_OTHER|||||||0.0448|||||||Fisher Exact|||||||0.0448
71938730|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.4|STANDARD_ERROR_OF_MEAN|0.23||0.0731|TWO_SIDED|95.0|-0.9|0.0|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg QD||0.0|-0.9|0.0731
71938731|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.5|STANDARD_ERROR_OF_MEAN|0.23||0.0259|TWO_SIDED|95.0|-1.0|-0.1|||ANCOVA|||Sleep: Placebo vs DS-5565 15 mg BID||-0.1|-1.0|0.0259
71938732|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.23||0.5243|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.6|-0.3|0.5243
71938733|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.23||0.8488|TWO_SIDED|95.0|-0.4|0.5|||ANCOVA|||Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.5|-0.4|0.8488
71938734|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|-0.2|STANDARD_ERROR_OF_MEAN|0.22||0.2746|TWO_SIDED|95.0|-0.7|0.2|||ANCOVA|||Enjoyment of life: Placebo vs Pregabalin 150 mg BID||0.2|-0.7|0.2746
71938735|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.0|STANDARD_ERROR_OF_MEAN|0.22||0.9349|TWO_SIDED|95.0|-0.4|0.4|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg QD||0.4|-0.4|0.9349
71938736|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.1|STANDARD_ERROR_OF_MEAN|0.22||0.5164|TWO_SIDED|95.0|-0.3|0.6|||ANCOVA|||Enjoyment of life: Placebo vs DS-5565 15 mg BID||0.6|-0.3|0.5164
71938737|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.3|STANDARD_ERROR_OF_MEAN|0.22||0.2382|TWO_SIDED|95.0|-0.2|0.7|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD||0.7|-0.2|0.2382
71938738|NCT02146430|143398161|SUPERIORITY||Difference in least squares means|0.4|STANDARD_ERROR_OF_MEAN|0.22||0.0807|TWO_SIDED|95.0|0.0|0.8|||ANCOVA|||Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID||0.8|-0.0|0.0807
71938739|NCT02146430|143398162|SUPERIORITY||Difference in least squares means|-0.045|STANDARD_ERROR_OF_MEAN|0.0237||0.0601|TWO_SIDED|95.0|-0.091|0.002|||ANCOVA|||||0.002|-0.091|0.0601
71938740|NCT02146430|143398162|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8299|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8299
71938741|NCT02146430|143398162|SUPERIORITY||Difference in least squares means|-0.05|STANDARD_ERROR_OF_MEAN|0.0237||0.0347|TWO_SIDED|95.0|-0.096|0.004|||ANCOVA|||||0.004|-0.096|0.0347
71938742|NCT02146430|143398162|SUPERIORITY||Difference in least squares means|0.04|STANDARD_ERROR_OF_MEAN|0.0237||0.0951|TWO_SIDED|95.0|-0.007|0.086|||ANCOVA|||||0.086|-0.007|0.0951
71938743|NCT02146430|143398162|SUPERIORITY||Difference in least squares means|-0.005|STANDARD_ERROR_OF_MEAN|0.0237||0.8199|TWO_SIDED|95.0|-0.052|0.041|||ANCOVA|||||0.041|-0.052|0.8199
71938744|NCT01893905|143398163|SUPERIORITY_OR_OTHER||||||<|0.0307|||||||Pocock approach|||||||<0.0307
71938745|NCT03197064|143398244|OTHER|||||||0.35|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.35
71938746|NCT03197064|143398244|OTHER|||||||0.47|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.47
71938747|NCT03197064|143398244|OTHER|||||||0.066|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.066
71938748|NCT03197064|143398245|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.72
71938749|NCT03197064|143398245|OTHER|||||||0.72|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.72
71938750|NCT03197064|143398245|OTHER|||||||0.78|||||||t-test, 2 sided|||Difference in right upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.78
71938751|NCT03197064|143398246|OTHER|||||||0.93|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.93
71938752|NCT03197064|143398246|OTHER|||||||0.39|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.39
71938753|NCT03197064|143398246|OTHER|||||||0.08|||||||t-test, 2 sided|||Difference in left lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.08
71938754|NCT03197064|143398247|OTHER|||||||0.42|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.42
71938755|NCT03197064|143398247|OTHER|||||||0.37|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.37
71938756|NCT03197064|143398247|OTHER|||||||0.49|||||||t-test, 2 sided|||Difference in right lower extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.49
71938757|NCT03197064|143398248|OTHER|||||||0.386|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 30 minutes post-dose||||0.386
71938758|NCT03197064|143398248|OTHER|||||||0.388|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 60 minutes post-dose||||0.388
71938759|NCT03197064|143398248|OTHER|||||||0.247|||||||t-test, 2 sided|||Difference in left upper extremity amplitude between baseline (pre-dose) and 90 minutes post-dose||||0.247
71938760|NCT01884025|143398267|SUPERIORITY_OR_OTHER|||||||0.59|||||||t-test, 2 sided|t-Value: 0.55||Change in total BADS score.||||0.59
71938761|NCT01884025|143398267|SUPERIORITY|||||||0.98|||||||t-test, 2 sided|t Value: 0.03||Change in Activation Subscale||||0.98
71938762|NCT01884025|143398267|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|"DF: 18~1 Value: -0.04"||Change in Avoidance/Rumination Subscale||||0.96
71938763|NCT01884025|143398267|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|t Value: 1.31||Change in Work/School Impairment Subscale||||0.21
71938764|NCT01884025|143398267|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|t Value: 0.99||Change in Social Impairment Subscale||||0.34
71938765|NCT01884025|143398268|SUPERIORITY|||||||0.75|||||||t-test, 2 sided|t Value: 0.33||||||0.75
71938766|NCT01884025|143398269|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||Change in overall physical activity frequency were compared between the two groups.||||0.72
71938767|NCT01884025|143398269|SUPERIORITY|||||||0.7|||||||t-test, 2 sided|t Value: -0.39||Change in moderate physical activity frequency between the two groups.||||0.70
71938768|NCT01884025|143398270|SUPERIORITY|||||||0.45|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 0.77||Change in the physical health scale of the RAND 12 were compared.||||0.45
71938769|NCT01884025|143398270|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|t Value: 0.76||Change in the mental health scale of the RAND 12 were compared.||||0.45
71938770|NCT01884025|143398271|SUPERIORITY_OR_OTHER|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||||||0.72
71938771|NCT01884025|143398272|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|t Value: 0.15||||||0.88
71938772|NCT01884025|143398273|SUPERIORITY|||||||0.08|ONE_SIDED|95.0|||||t-test, 2 sided|t Value: 1.83||||||.08
71938773|NCT01884025|143398274|SUPERIORITY|||||||0.16||||||Chi Squared 1.98|Chi-squared|||||||.16
71938774|NCT01884025|143398275|SUPERIORITY|||||||0.85||||||t value: .19|t-test, 2 sided|||||||.85
71938775|NCT01884025|143398276|SUPERIORITY|||||||0.6||||||t value: .54|t-test, 2 sided|||||||.60
71938776|NCT01884025|143398277|SUPERIORITY|||||||0.26||||||t value: -1.17|t-test, 2 sided|||||||.26
71938777|NCT01884025|143398278|SUPERIORITY|||||||0.08||||||t value: 1.85|t-test, 2 sided|||||||.08
71938778|NCT02059993|143398283|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.||||<0.05
71938779|NCT02059993|143398284|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71938780|NCT02655237|143398286|NON_INFERIORITY|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between Relugolix 40 mg group and leuprorelin group (Relugolix 40 mg group - leuprorelin group), using Farrington and Manning (FM) method. If the lower boundary of the 95% CI was greater or equal to the non-inferiority margin of -15%, then the non-inferiority of Relugolix 40 mg to leuprorelin was concluded.|Difference in percentage|-0.9||||0.0013|TWO_SIDED|95.0|-10.098|8.346|||Farrington and Manning (FM)||Relugolix 40 mg-Leuprorelin|||8.346|-10.098|0.0013
71693101|NCT02937623|142900951|OTHER||Least square mean difference|-0.44|||<|0.0001||95.0|-0.591|-0.297|||ANCOVA|ANCOVA model: change from baseline in Schiff sensitivity score as response and treatment as factors and baseline Schiff sensitivity score as covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|||-0.297|-0.591|<.0001
71693102|NCT04265261|142901006|SUPERIORITY||Risk Difference (RD)|1.19||||0.8586|TWO_SIDED|95.0|-11.86|14.23|||Cochran-Mantel-Haenszel|||||14.23|-11.86|0.8586
71938781|NCT02655237|143398287|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|32.5|||||TWO_SIDED|95.0|20.953|44.134|||||Relugolix 40 mg-Leuprorelin|||44.134|20.953|
71938782|NCT02655237|143398288|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-10.6|||||TWO_SIDED|95.0|-18.337|-2.883|||||Relugolix 40 mg-Leuprorelin|||-2.883|-18.337|
71938783|NCT02655237|143398289|OTHER|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-13.3|||||TWO_SIDED|95.0|-21.418|-5.118|||||Relugolix 40 mg-Leuprorelin|||-5.118|-21.418|
71938784|NCT02655237|143398290|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-12.05|||||TWO_SIDED|95.0|-19.778|-4.33|||||Relugolix 40 mg-Leuprorelin|Week 2||-4.330|-19.778|
71938785|NCT02655237|143398290|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-2.55|||||TWO_SIDED|95.0|-11.916|6.819|||||Relugolix 40 mg-Leuprorelin|Week 4||6.819|-11.916|
71693103|NCT04265261|142901006|SUPERIORITY||Risk Difference (RD)|-2.93||||0.6388|TWO_SIDED|95.0|-15.18|9.31|||Cochran-Mantel-Haenszel|||||9.31|-15.18|0.6388
71938786|NCT02655237|143398290|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|4.69|||||TWO_SIDED|95.0|-3.141|12.529|||||Relugolix 40 mg-Leuprorelin|Week 8||12.529|-3.141|
71938787|NCT02655237|143398290|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.59|||||TWO_SIDED|95.0|-3.433|10.605|||||Relugolix 40 mg-Leuprorelin|Week 12||10.605|-3.433|
71938788|NCT02655237|143398290|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.96|||||TWO_SIDED|95.0|-3.319|11.245|||||Relugolix 40 mg-Leuprorelin|Week 24||11.245|-3.319|
71938789|NCT02655237|143398291|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-15.15|||||TWO_SIDED|95.0|-20.786|-9.509|||||Relugolix 40 mg-Leuprorelin|Week 2||-9.509|-20.786|
71938790|NCT02655237|143398291|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-10.27|||||TWO_SIDED|95.0|-17.291|-3.246|||||Relugolix 40 mg-Leuprorelin|Week 4||-3.246|-17.291|
71938791|NCT02655237|143398291|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.89|||||TWO_SIDED|95.0|-6.996|5.209|||||Relugolix 40 mg-Leuprorelin|Week 8||5.209|-6.996|
71938792|NCT02655237|143398291|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.94|||||TWO_SIDED|95.0|-6.964|5.076|||||Relugolix 40 mg-Leuprorelin|Week 12||5.076|-6.964|
71938793|NCT02655237|143398291|OTHER|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|0.86|||||TWO_SIDED|95.0|-6.206|7.935|||||Relugolix 40 mg-Leuprorelin|Week 24||7.935|-6.206|
71938794|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|0.015|0.381|||||Relugolix 40 mg-Leuprorelin|Week 4||0.381|0.015|
71938795|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-0.135|0.333|||||Relugolix 40 mg-Leuprorelin|Week 8||0.333|-0.135|
71938796|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.189|0.323|||||Relugolix 40 mg-Leuprorelin|Week 12||0.323|-0.189|
71938797|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.01|||||TWO_SIDED|95.0|-0.275|0.251|||||Relugolix 40 mg-Leuprorelin|Week 16||0.251|-0.275|
71938798|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.1|||||TWO_SIDED|95.0|-0.386|0.18|||||Relugolix 40 mg-Leuprorelin|Week 20||0.180|-0.386|
71938799|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.09|||||TWO_SIDED|95.0|-0.385|0.209|||||Relugolix 40 mg-Leuprorelin|Week 24||0.209|-0.385|
71938800|NCT02655237|143398292|OTHER|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.49|||||TWO_SIDED|95.0|-0.787|-0.199|||||Relugolix 40 mg-Leuprorelin|Follow up (up to Week 28)||-0.199|-0.787|
71938801|NCT02655237|143398293|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.07|||||TWO_SIDED|95.0|-0.032|0.174|||||Relugolix 40 mg-Leuprorelin|Week 6 to 12||0.174|-0.032|
71938802|NCT02655237|143398293|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.05|||||TWO_SIDED|95.0|-0.089|0.197|||||Relugolix 40 mg-Leuprorelin|Week 2 to 6||0.197|-0.089|
71938803|NCT02655237|143398293|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.01|||||TWO_SIDED|95.0|-0.06|0.086|||||Relugolix 40 mg-Leuprorelin|Week 18 to 24||0.086|-0.060|
71938804|NCT02655237|143398293|OTHER|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.02|||||TWO_SIDED|95.0|-0.063|0.099|||||Relugolix 40 mg-Leuprorelin|For 6 Weeks Before the Final Dose (up to Week 24)||0.099|-0.063|
71938805|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-2.5|||||TWO_SIDED|95.0|-6.39|1.43|||||Relugolix 40 mg-Leuprorelin|Week 4||1.43|-6.39|
71938806|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-4.0|||||TWO_SIDED|95.0|-6.68|-1.31|||||Relugolix 40 mg-Leuprorelin|Week 8||-1.31|-6.68|
71693104|NCT03877224|142901011|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.16||||0.07905|TWO_SIDED|95.0|0.36|6.01||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-TSS, the following hypothesis was tested using the significance level 0.04990 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-TSS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||6.01|0.36|0.07905
71693105|NCT03877224|142901012|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|3.12||||0.23215|TWO_SIDED|95.0|-0.09|5.37||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, weeks impacted by COVID-19 and treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint KCCQ-PLS, the following hypothesis was tested at significant level of 0.00005 • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, KCCQ-PLS, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||5.37|-0.09|0.23215
71693106|NCT03877224|142901013|SUPERIORITY||Hodges-Lehmann median diff. vs placebo|1.6||||0.66801|TWO_SIDED|95.0|-5.9|9.0||To account for multiplicity, a pre-specified testing strategy was followed to control the overall type I error rate.|Rank ANCOVA|The model includes rank-based baseline, treatment group as covariates and is stratified by T2DM status at randomization||For the primary efficacy endpoint 6MWD, the following hypothesis was tested using the significance level 0.00005: H0: m(r(A)) = m(r(C)) versus H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in the primary efficacy endpoint, 6MWD, from baseline to week 16, among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||9.0|-5.9|0.66801
71693107|NCT03877224|142901014|SUPERIORITY|Total time spent in LVPA was not tested for statistical significance and the p-value is considered nominal because the test for 6MWD was not statistically significant.|Hodges-Lehmann median diff. vs placebo|0.19||||0.12523|TWO_SIDED|95.0|-0.06|0.48|||Rank ANCOVA|Model includes baseline rank of outcome variable as a covariate, treatment group as a factor, and is stratified by T2DM status at randomization.||For the secondary efficacy endpoint, total time spent in LVPA, the testing hypothesis is • H0: m(r(A)) = m(r(C)) versus • H1: m(r(A)) ≠ m(r(C)) Where H0 and H1 are the null and alternative hypotheses, respectively, and m(r(A)) and m(r(C)) represent the median of the ranked changes in secondary efficacy endpoint, total time spent in LVPA, from baseline to End of study among patients receiving dapagliflozin (Active) and placebo (Control) treatment, respectively.||0.48|-0.06|0.12523
71693108|NCT00823134|142901064|OTHER||Mean Difference (Final Values)|2.8|STANDARD_DEVIATION|4.7||0.021|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.021
71693109|NCT00823134|142901065|OTHER|The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).|Correlation coefficient (Bland-Altman)|0.75|||||TWO_SIDED|||||||||Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \>75% will be seen as threshold for validity.||||
71693110|NCT02291029|142901071|SUPERIORITY||Mean Difference (Net)|-0.41||||0.397|TWO_SIDED|95.0|-3.7|2.89||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.89|-3.70|0.397
71693111|NCT02291029|142901071|SUPERIORITY||Mean Difference (Net)|-5.21||||0.009|TWO_SIDED|95.0|-9.46|-0.96||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||-0.96|-9.46|0.009
71938807|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||TWO_SIDED|95.0|-1.99|2.36|||||Relugolix 40 mg-Leuprorelin|Week 12||2.36|-1.99|
71693112|NCT02291029|142901071|SUPERIORITY||Mean Difference (Net)|2.34||||0.344|TWO_SIDED|95.0|-2.78|7.45||two-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.||||7.45|-2.78|0.344
71938808|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|1.3|||||TWO_SIDED|95.0|-0.68|3.28|||||Relugolix 40 mg-Leuprorelin|Week 16||3.28|-0.68|
71938809|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-1.8|2.32|||||Relugolix 40 mg-Leuprorelin|Week 20||2.32|-1.80|
71693113|NCT02291029|142901072|SUPERIORITY||Mean Difference (Net)|-1.09||||0.205|TWO_SIDED|95.0|-2.97|0.8|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.80|-2.97|0.205
71693114|NCT02291029|142901072|SUPERIORITY||Mean Difference (Net)|-0.95||||0.188|TWO_SIDED|95.0|-2.41|0.5|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||0.50|-2.41|0.188
71938810|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.5|||||TWO_SIDED|95.0|-1.48|2.52|||||Relugolix 40 mg-Leuprorelin|Week 24||2.52|-1.48|
71938811|NCT02655237|143398294|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|3.4|||||TWO_SIDED|95.0|1.08|5.77|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||5.77|1.08|
71938812|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.3|||||TWO_SIDED|95.0|-1.66|6.34|||||Relugolix 40 mg-Leuprorelin|Week 4||6.34|-1.66|
71938813|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.7|||||TWO_SIDED|95.0|-0.37|5.77|||||Relugolix 40 mg-Leuprorelin|Week 8||5.77|-0.37|
71938814|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.9|||||TWO_SIDED|95.0|-1.84|3.61|||||Relugolix 40 mg-Leuprorelin|Week 12||3.61|-1.84|
71938815|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||TWO_SIDED|95.0|-2.61|2.79|||||Relugolix 40 mg-Leuprorelin|Week 16||2.79|-2.61|
71938816|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.8|||||TWO_SIDED|95.0|-1.74|3.41|||||Relugolix 40 mg-Leuprorelin|Week 20||3.41|-1.74|
71938817|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||TWO_SIDED|95.0|-2.07|2.71|||||Relugolix 40 mg-Leuprorelin|Week 24||2.71|-2.07|
71938818|NCT02655237|143398295|OTHER|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-1.4|||||TWO_SIDED|95.0|-3.96|1.09|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)||1.09|-3.96|
71938819|NCT01860976|143398305|SUPERIORITY_OR_OTHER_LEGACY||Estimate of Difference|17.2|||<|0.001|TWO_SIDED|95.0|8.7|25.6|||Cochran-Mantel-Haenszel|||||25.6|8.7|<0.001
71938820|NCT02907203|143398337|NON_INFERIORITY|Compared with the Performance Goal: 0.9mm|Mean Difference (Net)|-0.17|STANDARD_DEVIATION|0.98||0|TWO_SIDED|95.0|-0.5|0.152|||t-test, 2 sided|||||0.152|-0.5|0.000
71938821|NCT01816477|143398344|SUPERIORITY_OR_OTHER|||||||0.55|||||||t-test, 2 sided|||||||0.55
71938822|NCT01816477|143398345|SUPERIORITY_OR_OTHER|||||||0.0872|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.0872
71938823|NCT01816477|143398345|SUPERIORITY_OR_OTHER|||||||0.6751|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.6751
71938824|NCT01816477|143398345|SUPERIORITY_OR_OTHER|||||||0.1203|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.1203
71938825|NCT01816477|143398345|SUPERIORITY_OR_OTHER|||||||0.3582|||||||Unequal Variance T-Test|||Comparison between groups for day 4.||||0.3582
71938826|NCT01816477|143398345|SUPERIORITY_OR_OTHER|||||||0.0625|||||||Unequal Variance T-Test|||Comparison between groups for day 5||||0.0625
71938827|NCT01816477|143398345|SUPERIORITY_OR_OTHER|||||||0.0484|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.0484
71938828|NCT01816477|143398346|SUPERIORITY_OR_OTHER|||||||0.6465|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.||||0.6465
71938829|NCT01816477|143398346|SUPERIORITY_OR_OTHER|||||||0.9233|||||||Unequal Variance T-Test|||Comparison between groups for day 2.||||0.9233
71938830|NCT01816477|143398346|SUPERIORITY_OR_OTHER|||||||0.5788|||||||Unequal Variance T-Test|||Comparison between groups for day 3.||||0.5788
71938831|NCT01816477|143398346|SUPERIORITY_OR_OTHER|||||||0.1036|||||||Unequal Variance T-Test|||Comparison between the groups for day 4.||||0.1036
71938832|NCT01816477|143398346|SUPERIORITY_OR_OTHER|||||||0.5314|||||||Unequal Variance T-Test|||Comparison between groups for day 5.||||0.5314
71938833|NCT01816477|143398346|SUPERIORITY_OR_OTHER|||||||0.7166|||||||Unequal Variance T-Test|||Comparison between groups for day 6.||||0.7166
71938834|NCT00585780|143398383|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing HDD% among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.23||||0.016|TWO_SIDED|95.0|0.1|0.55||This is for the apriori hypothesis of significant AWX Treatment X Time effect.|Mixed Models Analysis|Simple effects were conducted to assess source of the interaction.||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.55|0.1|0.016
71938835|NCT00585780|143398384|OTHER|Expected outcome was that Prazosin will be better than placebo in reducing percent of drinking days (DD%) among High AW individuals but no differences by medication treatment in the Low AW individuals.|Odds Ratio (OR)|0.5||||0.002|TWO_SIDED|95.0|0.28|0.92||This is for apriori hypothesized significant AW X Treatment X Post-full dose time interaction effect.|Mixed Models Analysis|||Intent-to-treat (ITT) analyses with baseline AW severity (mean-centered continuous CIWA-Ar scores) as a moderator of Time (Pre-Full Dose(FD): weeks 1-2; Post FD: weeks 3-12) were conducted with linear or generalized linear mixed effect (LME/GLME) piecewise growth models for continuous and binary outcomes. Control variables that were modeled in all analyses. As hypothesized, significant interactions were tested using AW median cut-offs for high and Low AW groups.||0.92|0.28|0.002
71693115|NCT02291029|142901072|SUPERIORITY||Mean Difference (Net)|-0.37||||0.663|TWO_SIDED|95.0|-2.08|1.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.35|-2.08|0.663
71693116|NCT02291029|142901073|SUPERIORITY||Mean Difference (Net)|-15.26||||0.161|TWO_SIDED|95.0|-37.9|7.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||7.38|-37.90|0.161
71693117|NCT02291029|142901073|SUPERIORITY||Mean Difference (Net)|-12.16||||0.017|TWO_SIDED|95.0|-21.94|-2.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||-2.38|-21.94|0.017
71693118|NCT02291029|142901074|SUPERIORITY||Mean Difference (Net)|-9.45||||0.456|TWO_SIDED|95.0|-36.2|17.3|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||17.30|-36.20|0.456
71693119|NCT02291029|142901074|SUPERIORITY||Mean Difference (Net)|-8.14||||0.376|TWO_SIDED|95.0|-26.67|10.39|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||10.39|-26.67|0.376
71693120|NCT02291029|142901075|SUPERIORITY||Mean Difference (Net)|-5.5||||0.172|TWO_SIDED|95.0|-13.91|2.91|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||2.91|-13.91|0.172
71693121|NCT02291029|142901075|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
71693122|NCT02291029|142901076|SUPERIORITY||Mean Difference (Net)|-0.07||||0.986|TWO_SIDED|95.0|-8.49|8.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||8.35|-8.49|0.986
71693123|NCT02291029|142901076|SUPERIORITY||Mean Difference (Net)|3.83||||0.175|TWO_SIDED|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||9.48|-1.81|0.175
71693124|NCT02291029|142901077|SUPERIORITY||Mean Difference (Net)|1.34||||0.807|TWO_SIDED|95.0|-10.48|13.15|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||13.15|-10.48|0.807
71693125|NCT02291029|142901077|SUPERIORITY||Mean Difference (Net)|-9.83||||0.074|TWO_SIDED|95.0|-20.66|1.01|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate||||1.01|-20.66|0.074
71693126|NCT00078403|142901078|SUPERIORITY_OR_OTHER_LEGACY|||||||0.58||||||P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.|Exact Wilcoxon rank sum test|||Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.||||0.58
71693127|NCT02922153|142901096|SUPERIORITY|||||||0.0223|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided, two-sample t-test.||||||0.0223
71693128|NCT02922153|142901097|SUPERIORITY|||||||0.6259|TWO_SIDED|95.0|||||t-test, 1 sided|One-sided two-sample t-test.||||||0.6259
71693129|NCT02922153|142901097|SUPERIORITY|||||||0.518|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Wilcoxon two-sample test.||||||0.518
71693130|NCT02922153|142901098|SUPERIORITY|||||||0.0201||||||FEV1 one-sided, two-sample t-test|t-test, 1 sided|||||||0.0201
71693131|NCT02922153|142901098|SUPERIORITY|||||||0.06||||||FVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.06
71693132|NCT02922153|142901098|SUPERIORITY|||||||0.09||||||SVC one-sided, two-sample t-test|t-test, 1 sided|||||||0.09
71693133|NCT02922153|142901099|SUPERIORITY|||||||0.3085||||||72 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.3085
71693134|NCT02922153|142901099|SUPERIORITY|||||||0.8196||||||96 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.8196
71693135|NCT02922153|142901099|SUPERIORITY|||||||0.7269||||||120 Hours Post-Op|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.||||||0.7269
71693136|NCT02922153|142901101|SUPERIORITY|||||||0.4421|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||Analysis is the time from end of procedure to oral endotracheal extubation||||0.4421
71693137|NCT02922153|142901102|SUPERIORITY|||||||0.4352||||||Total Post-Procedure for Hospital Stay|Wilcoxon (Mann-Whitney)|Wilcoxon Rank-Sum Test||||||0.4352
71693138|NCT02922153|142901103|SUPERIORITY|||||||0.2939||||||ICU Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.2939
71693139|NCT02922153|142901103|SUPERIORITY|||||||0.0998||||||Hospital Length of Stay|Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test||||||0.0998
71693140|NCT02922153|142901104|SUPERIORITY|||||||0.2877|||||||Chi-squared|||48 Hours Post-Op: Patient able to sit up in bed||||0.2877
71693141|NCT02922153|142901104|SUPERIORITY|||||||0.5311|||||||Fisher Exact|||48 Hours Post-Op: Patient able to stand up||||0.5311
71693142|NCT02922153|142901104|SUPERIORITY|||||||0.4908|||||||Fisher Exact|||48 Hours Post-Op: Patient able to walk||||0.4908
71693143|NCT02922153|142901104|SUPERIORITY|||||||0.8621|||||||Fisher Exact|||48 Hours Post-Op: Right Shoulder Flexion Movement||||0.8621
71693144|NCT02922153|142901104|SUPERIORITY|||||||1|||||||Fisher Exact|||48 Hours Post-Op: Left Shoulder Flexion Movement||||1
71693145|NCT02922153|142901104|SUPERIORITY|||||||0.0133|||||||Fisher Exact|||72 Hours Post-Op: Patient able to sit up in bed||||0.0133
71693146|NCT02922153|142901104|SUPERIORITY|||||||0.0037|||||||Fisher Exact|||72 Hours Post-Op: Patient able to stand up||||0.0037
71693147|NCT02922153|142901104|SUPERIORITY|||||||0.1671|||||||Fisher Exact|||72 Hours Post-Op: Patient able to walk||||0.1671
71938836|NCT02978326|143398390|SUPERIORITY||Least Squares (LS) Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|1.37||0.0028|TWO_SIDED|95.0|-6.9|-1.5||Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||||-1.5|-6.9|0.0028
71938837|NCT02978326|143398391|SUPERIORITY||LS Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|1.19||0.0252|TWO_SIDED|95.0|-5.1|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 3||-0.3|-5.1|0.0252
71693148|NCT02922153|142901104|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Right Shoulder Flexion Movement||||1.000
71693149|NCT02922153|142901104|SUPERIORITY|||||||1|||||||Fisher Exact|||72 Hours Post-Op: Left Shoulder Flexion Movement||||1
71693150|NCT02922153|142901104|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Patient able to sit up in bed||||1
71693151|NCT02922153|142901104|SUPERIORITY|||||||0.2757|||||||Fisher Exact|||96 Hours Post-Op: Patient able to stand up||||0.2757
71693152|NCT02922153|142901104|SUPERIORITY|||||||0.9025|||||||Fisher Exact|||96 Hours Post-Op: Patient able to walk||||0.9025
71693153|NCT02922153|142901104|SUPERIORITY|||||||0.7942|||||||Fisher Exact|||96 Hours Post-Op: Right Shoulder Flexion Movement||||0.7942
71693154|NCT02922153|142901104|SUPERIORITY|||||||1|||||||Fisher Exact|||96 Hours Post-Op: Left Shoulder Flexion Movement||||1
71693155|NCT02922153|142901104|SUPERIORITY|||||||0.3492|||||||Fisher Exact|||120 Hours Post-Op: Patient able to sit up in bed||||0.3492
71693156|NCT02922153|142901104|SUPERIORITY|||||||0.2644|||||||Fisher Exact|||120 Hours Post-Op: Patient able to stand up||||0.2644
71938838|NCT02978326|143398391|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|1.31||0.0106|TWO_SIDED|95.0|-6.0|-0.8||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 8||-0.8|-6.0|0.0106
71938839|NCT02978326|143398391|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.44||0.0321|TWO_SIDED|95.0|-6.0|-0.3||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 21||-0.3|-6.0|0.0321
71693157|NCT02922153|142901104|SUPERIORITY|||||||0.8258|||||||Fisher Exact|||120 Hours Post-Op: Patient able to walk||||0.8258
71693158|NCT02922153|142901104|SUPERIORITY|||||||0.67|||||||Fisher Exact|||120 Hours Post-Op: Right Shoulder Flexion Movement||||0.67
71693159|NCT02922153|142901104|SUPERIORITY|||||||0.5693|||||||Fisher Exact|||120 Hours Post-Op: Left Shoulder Flexion Movement||||0.5693
71693160|NCT02922153|142901104|SUPERIORITY|||||||0.1189|||||||Chi-squared|||Discharge: Patient able to sit up in bed||||0.1189
71693161|NCT02922153|142901104|SUPERIORITY|||||||1|||||||Fisher Exact|||Discharge: Patient able to stand up||||1
71693162|NCT02922153|142901104|SUPERIORITY|||||||0.6992|||||||Fisher Exact|||Discharge: Patient able to walk||||0.6992
71693163|NCT02922153|142901104|SUPERIORITY|||||||0.4429|||||||Fisher Exact|||Discharge: Right Shoulder Flexion Movement||||0.4429
71693164|NCT02922153|142901104|SUPERIORITY|||||||0.4563|||||||Fisher Exact|||Discharge: Left Shoulder Flexion Movement||||0.4563
71693165|NCT03429348|142901105|SUPERIORITY||Mean Difference (Final Values)|1.18||||9e-07|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values.||||||0.0000009
71693166|NCT03429348|142901105|SUPERIORITY||Mean Difference (Final Values)|1.35||||1.8e-05|TWO_SIDED||||||t-test, 2 sided|We are comparing the log transformed values||||||0.000018
71693167|NCT02692586|142901106|SUPERIORITY|To detect an RV/LV ratio change \> 0.12 with a power of 80% at one-sided alpha = 0.025, the necessary sample size was calculated to be ≥ 52, 31, or 21 patients (to detect RV/LV ratio changes of 0.20, 0.225, or 0.25, respectively).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
71693168|NCT02692586|142901107|SUPERIORITY|The hypothesized composite MAE rate was expected to be about 13%. The necessary sample size to detect a difference from an expected MAE rate of 13% with 80% power was calculated to be 103 patients (with a one-sided p value = 0.05).|||||<|0.0001|||||||t-test, 1 sided|||||||< 0.0001
71693169|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|1.0|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|1.00|
71693170|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.99|1.01|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.01|0.99|
71938840|NCT02978326|143398391|SUPERIORITY||LS Mean Difference|-4.1|STANDARD_ERROR_OF_MEAN|1.34||0.0027|TWO_SIDED|95.0|-6.7|-1.4||MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in the HAM-D Total Score at Day 45||-1.4|-6.7|0.0027
71938841|NCT02978326|143398392|SUPERIORITY||Odds Ratio (OR)|1.79||||0.1004|TWO_SIDED|95.0|0.89|3.6||Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 3||3.60|0.89|0.1004
71938842|NCT02978326|143398392|SUPERIORITY||Odds Ratio (OR)|2.31||||0.0127|TWO_SIDED|95.0|1.2|4.45||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 8||4.45|1.20|0.0127
71938843|NCT02978326|143398392|SUPERIORITY||Odds Ratio (OR)|2.63||||0.0049|TWO_SIDED|95.0|1.34|5.16||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 15||5.16|1.34|0.0049
71938844|NCT02978326|143398392|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0763|TWO_SIDED|95.0|0.94|3.64||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 21||3.64|0.94|0.0763
71938845|NCT02978326|143398392|SUPERIORITY||Odds Ratio (OR)|2.28||||0.0216|TWO_SIDED|95.0|1.13|4.6||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Response at Day 45||4.60|1.13|0.0216
71938846|NCT02978326|143398393|SUPERIORITY||Odds Ratio (OR)|3.89||||0.02|TWO_SIDED|95.0|1.24|12.23||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 3||12.23|1.24|0.0200
71938847|NCT02978326|143398393|SUPERIORITY||Odds Ratio (OR)|1.91||||0.099|TWO_SIDED|95.0|0.89|4.13||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 8||4.13|0.89|0.0990
71938848|NCT02978326|143398393|SUPERIORITY||Odds Ratio (OR)|2.53||||0.011|TWO_SIDED|95.0|1.24|5.17||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 15||5.17|1.24|0.0110
71938849|NCT02978326|143398393|SUPERIORITY||Odds Ratio (OR)|1.58||||0.1982|TWO_SIDED|95.0|0.79|3.19||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 21||3.19|0.79|0.1982
71938850|NCT02978326|143398393|SUPERIORITY||Odds Ratio (OR)|2.52||||0.0091|TWO_SIDED|95.0|1.26|5.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With HAM-D Remission at Day 45||5.03|1.26|0.0091
71938851|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-2.1|STANDARD_ERROR_OF_MEAN|2.41||0.3832|TWO_SIDED|95.0|-6.9|2.7||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 3||2.7|-6.9|0.3832
71938852|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-5.4|STANDARD_ERROR_OF_MEAN|2.6||0.0415|TWO_SIDED|95.0|-10.5|-0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 8||-0.2|-10.5|0.0415
71938853|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|2.71||0.0606|TWO_SIDED|95.0|-10.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 15||0.2|-10.5|0.0606
71938854|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-6.3|STANDARD_ERROR_OF_MEAN|2.91||0.0318|TWO_SIDED|95.0|-12.1|-0.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 21||-0.6|-12.1|0.0318
71938855|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-7.7|STANDARD_ERROR_OF_MEAN|2.69||0.0047|TWO_SIDED|95.0|-13.0|-2.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Core: Change from Baseline in HAM-D Subscale Score at Day 45||-2.4|-13.0|0.0047
71938856|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|2.5||0.0053|TWO_SIDED|95.0|-12.0|-2.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3||-2.1|-12.0|0.0053
71938857|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-6.6|STANDARD_ERROR_OF_MEAN|2.76||0.0181|TWO_SIDED|95.0|-12.1|-1.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8||-1.1|-12.1|0.0181
71938858|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-9.8|STANDARD_ERROR_OF_MEAN|2.82||0.0007|TWO_SIDED|95.0|-15.3|-4.2|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15||-4.2|-15.3|0.0007
71938859|NCT02978326|143398394|OTHER||LS Mean Difference|-6.0|STANDARD_ERROR_OF_MEAN|2.79||0.0332|TWO_SIDED|95.0|-11.5|-0.5|||Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21||-0.5|-11.5|0.0332
71938860|NCT02978326|143398394|OTHER||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|2.8||0.0048|TWO_SIDED|95.0|-13.5|-2.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45||-2.5|-13.5|0.0048
71938861|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-4.2|STANDARD_ERROR_OF_MEAN|3.12||0.184|TWO_SIDED|95.0|-10.3|2.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3||2.0|-10.3|0.1840
71938862|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-6.7|STANDARD_ERROR_OF_MEAN|3.31||0.0462|TWO_SIDED|95.0|-13.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8||-0.1|-13.2|0.0462
71938863|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-8.3|STANDARD_ERROR_OF_MEAN|3.36||0.015|TWO_SIDED|95.0|-14.9|-1.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15||-1.6|-14.9|0.0150
71938864|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-8.0|STANDARD_ERROR_OF_MEAN|3.53||0.0245|TWO_SIDED|95.0|-15.0|-1.0||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21||-1.0|-15.0|0.0245
71938865|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-9.4|STANDARD_ERROR_OF_MEAN|3.34||0.0054|TWO_SIDED|95.0|-16.0|-2.8||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45||-2.8|-16.0|0.0054
71693171|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.03|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.03|0.99|
71938866|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|2.77||0.0972|TWO_SIDED|95.0|-10.1|0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 3||0.9|-10.1|0.0972
71938867|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-7.2|STANDARD_ERROR_OF_MEAN|2.95||0.0155|TWO_SIDED|95.0|-13.1|-1.4||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 8||-1.4|-13.1|0.0155
71938868|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-7.5|STANDARD_ERROR_OF_MEAN|3.03||0.0149|TWO_SIDED|95.0|-13.4|-1.5||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 15||-1.5|-13.4|0.0149
71938869|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.14||0.025|TWO_SIDED|95.0|-13.3|-0.9||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 21||-0.9|-13.3|0.0250
71938870|NCT02978326|143398394|SUPERIORITY||LS Mean Difference|-9.5|STANDARD_ERROR_OF_MEAN|2.96||0.0017|TWO_SIDED|95.0|-15.3|-3.6||MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Meier: Change from Baseline in HAM-D Subscale Score at Day 45||-3.6|-15.3|0.0017
71938871|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1569|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.5|0.1569
71938872|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0376|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0376
71938873|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.18||0.1035|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.6|0.1035
71938874|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0037|TWO_SIDED|95.0|-0.9|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.2|-0.9|0.0037
71938875|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.18||0.0061|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.8|0.0061
71938876|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.16||0.7878|TWO_SIDED|95.0|-0.4|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.4|0.7878
71938877|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.0498|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0498
71938878|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.16||0.1719|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1719
71938879|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0161|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.7|0.0161
71693172|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving a pre-commitment prompt to the arm receiving no pre-commitment prompt.|||1.04|1.00|
71938880|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.15||0.0191|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0191
71938881|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.2537|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.2|0.2537
71938882|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.04||0.0018|TWO_SIDED|95.0|-0.2|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.2|0.0018
71938883|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.2878|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.2|0.2878
71938884|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.07||0.2594|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.2|0.2594
71938885|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0086|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.3|0.0086
71938886|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0424|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.6|0.0424
71938887|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0207|TWO_SIDED|95.0|-0.6|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.6|0.0207
71938888|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.14||0.001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0010
71938889|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.0871|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.5|0.0871
71938890|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.568|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45||0.2|-0.4|0.5680
71938891|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0143|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.6|0.0143
71938892|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0063|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.6|0.0063
71938893|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0042|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0042
71938894|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0137|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.6|0.0137
71938895|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.14||0.0099|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0099
71938896|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.14||0.0507|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0507
71693173|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.98|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.98|
71693174|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|0.95|0.97|1.02|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.02|0.97|
71693175|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.01|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.01|0.97|
71693176|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.98|1.05|||||These results compare the arm receiving gain-framed reminders to the arm receiving no reminders.|||1.05|0.98|
71693177|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.01|||||TWO_SIDED|95.0|0.99|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.99|
71693178|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.98|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.98|
71693179|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.97|1.02|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.02|0.97|
71693180|NCT04110314|142901114|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|1.0|1.04|||||These results compare the arm receiving loss-framed reminders to the arm receiving no reminders.|||1.04|1.00|
71693181|NCT01004978|142901191|SUPERIORITY|||||||0.4||||||one-sided p-value|Cochran-Mantel-Haenszel|||||||0.4
71938897|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0205|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0205
71938898|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1409|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.5|0.1409
71693182|NCT01004978|142901192|SUPERIORITY|||||||0.76|||||||Log Rank|||||||0.76
71693183|NCT01711983|142901201|NON_INFERIORITY|Non-inferiority margin based on 1) the lower 95% confidence bound (= 0.82) for estimated 6-month composite Clinical Success for the historical device (219/253=0.866), and 2) a worst-case analysis of 6-month composite Clinical Success for the historical device (0.81, assuming the 18 subjects with missing echo evaluations were failures).|Risk Difference (RD)|-0.0366|||<|0.0001|ONE_SIDED|95.0||0.007||A priori 1-sided alpha = 0.05.|2-sample binomial proportions test||Difference is control - test. Confidence interval is the upper one-sided 95% Wald confidence interval.|"Test null hypothesis of inferiority of test device (test) compared to historical device (control).~H0: Pc - Pt ≥ Δ vs H1: Pc - Pt \< Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.~Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0."||0.007||<0.0001
71693184|NCT01272908|142901264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.293||||0.253|||||||Regression, Logistic|||ACR20: Week 12 versus (vs) Week 4||||0.253
71693185|NCT01272908|142901264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.019||||0.005|||||||Regression, Logistic|||ACR20: Week 24 vs Week 4||||0.005
71693186|NCT01272908|142901264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.552||||0.023|||||||Regression, Logistic|||ACR50: Week 12 vs Week 4||||0.023
71693187|NCT01272908|142901264|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.861||||0.001|||||||Regression, Logistic|||ACR50: Week 24 vs. Week 4||||0.001
71693188|NCT01272908|142901268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.099||||0.667|||||||Regression, Logistic|||Good vs Moderate vs None: Week 12 vs Week 4||||0.667
71693189|NCT01272908|142901268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.589|||<|0.001|||||||Regression, Logistic|||Good vs Moderate vs None: Week 24 vs Week 4||||<0.001
71693190|NCT01272908|142901268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.138||||0.44|||||||Regression, Logistic|||Good/Moderate vs None: Week 12 vs Week 4||||0.440
71693191|NCT01272908|142901268|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.009||||0.012|||||||Regression, Logistic|||Good/Moderate vs None: Week 24 vs Week 4||||0.012
71693192|NCT01272908|142901270|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 4||||<0.001
71693193|NCT01272908|142901270|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 12||||<0.001
71693194|NCT01272908|142901270|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 24||||<0.001
71693195|NCT01272908|142901270|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 36||||<0.001
71693196|NCT01272908|142901270|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Week 48||||<0.001
71693197|NCT01272908|142901272|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed-Rank test|||Baseline vs Week 24||||<0.001
71693198|NCT01272908|142901274|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
71693199|NCT01272908|142901276|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
71693200|NCT01272908|142901278|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71693201|NCT01272908|142901280|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24||||<0.001
71693202|NCT01272908|142901282|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71693203|NCT01272908|142901284|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71693204|NCT01272908|142901286|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71693205|NCT01272908|142901290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 12||||<0.001
71693206|NCT01272908|142901290|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24||||<0.001
71693207|NCT03143101|142901293|SUPERIORITY||Mean Difference (Net)|18.1||||0.006|TWO_SIDED|95.0|4.8|30.9||p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||30.9|4.8|0.006
71938899|NCT02978326|143398395|SUPERIORITY|MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2021|TWO_SIDED|95.0|-0.5|0.1|||Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.5|0.2021
71693208|NCT03143101|142901297|SUPERIORITY||Mean Difference (Net)|32.7|||<|0.001|TWO_SIDED|95.0|14.4|47.8||p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel|||||47.8|14.4|<0.001
71693209|NCT01630135|142901310|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-1.089|||<|0.001|TWO_SIDED|95.0|-1.41|-0.76|||ANCOVA||The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.|||-0.76|-1.41|<0.001
71938900|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0117|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.6|0.0117
71938901|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.5511|TWO_SIDED|95.0|-0.4|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3||0.2|-0.4|0.5511
71938902|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.18||0.4949|TWO_SIDED|95.0|-0.5|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.5|0.4949
71938903|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0203|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0203
71938904|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2076|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.2076
71938905|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.19||0.0362|TWO_SIDED|95.0|-0.8|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.8|0.0362
71938906|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3589|TWO_SIDED|95.0|-0.1|0.3||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.3|-0.1|0.3589
71938907|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.6991|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.2|0.6991
71938908|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.9655|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15||0.2|-0.2|0.9655
71938909|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.8699|TWO_SIDED|95.0|-0.2|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.2|0.8699
71938910|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.3715|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.3715
71938911|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.067|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.4|0.0670
71693210|NCT03243305|142901327|OTHER||Seven-cycle Pregnancy Percentage|13.65|||||TWO_SIDED|95.0|9.91|17.39|||Kaplan-Meier|||The primary hypothesis to be tested is whether subjects using Amphora vaginal gel have a 7-cycle cumulative pregnancy percentage less than or equal to 21%||17.39|9.91|
71693211|NCT01585246|142901340|OTHER||Maximum Tolerated Dose (MTD)|960.0|||||TWO_SIDED|||||||||The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.||||
71938912|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0104|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8||-0.1|-0.5|0.0104
71938913|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.5|0.0122
71938914|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.3157|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.3|0.3157
71938915|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0077|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0077
71938916|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.16||0.0078|TWO_SIDED|95.0|-0.8|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3||-0.1|-0.8|0.0078
71938917|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.18||0.0372|TWO_SIDED|95.0|-0.7|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.7|0.0372
71938918|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0244|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.7|0.0244
71938919|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0993|TWO_SIDED|95.0|-0.6|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.6|0.0993
71938920|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.17||0.0185|TWO_SIDED|95.0|-0.7|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.7|0.0185
71938921|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2471|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2471
71938922|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.1076|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.1076
71693212|NCT01246895|142901373|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.017
71938923|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.2782|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.4|0.2782
71938924|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.4646|TWO_SIDED|95.0|-0.4|0.2|||Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21||0.2|-0.4|0.4646
71938925|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.14||0.16|TWO_SIDED|95.0|-0.5|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.5|0.1600
71938926|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0474|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.5|0.0474
71693213|NCT01246895|142901374|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||||||0.026
71938927|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0446|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.5|0.0446
71938928|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0093|TWO_SIDED|95.0|-0.6|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.1|-0.6|0.0093
71938929|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2998|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.2998
71938930|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.0545|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0545
71938931|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.2177|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.2177
71938932|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.4|0.2300
71938933|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12||0.0001|TWO_SIDED|95.0|-0.7|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.7|0.0001
71938934|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.12||0.0151|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0151
71938935|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.13||0.0502|TWO_SIDED|95.0|-0.5|0.0|||Mixed Model for Repeated Measures|||General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.5|0.0502
71938936|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.11||0.3659|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.3|0.3659
71938937|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.6003|TWO_SIDED|95.0|-0.3|0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8||0.2|-0.3|0.6003
71938938|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.0785|TWO_SIDED|95.0|-0.5|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.5|0.0785
71938939|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.13||0.3668|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.4|0.3668
71938940|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.13||0.1827|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.4|0.1827
71938941|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.12||0.1327|TWO_SIDED|95.0|-0.4|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3||0.1|-0.4|0.1327
71693214|NCT01246895|142901375|SUPERIORITY_OR_OTHER|||||||0.474|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Pain||||0.474
71693215|NCT01246895|142901375|SUPERIORITY_OR_OTHER|||||||0.236|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Stiffness||||0.236
71693216|NCT01246895|142901375|SUPERIORITY_OR_OTHER|||||||0.326|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Physical function||||0.326
71693217|NCT01246895|142901376|SUPERIORITY_OR_OTHER|||||||0.01|||||||Physical count|||||||0.01
71693218|NCT01246895|142901377|SUPERIORITY_OR_OTHER|||||||0.478|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Physical component||||0.478
71693219|NCT01246895|142901377|SUPERIORITY_OR_OTHER|||||||0.125|TWO_SIDED|||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Mental component||||0.125
71693220|NCT00871234|142901383|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.03||||0.36||95.0|||||Wilcoxon signed-rank|||||||0.36
71693221|NCT01261390|142901464|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.677|STANDARD_ERROR_OF_MEAN|1.652|||TWO_SIDED|95.0|-5.915|0.561|||||Presented average of the treatment effects on 24hr SBP at 6months and 12months: (6mo + 12mo)/ 2; Comparison: ActivePAP Control. Adjusted for randomization factors (CVD; site; sleepstudy type) with subjectspecific slopes and intercepts.|"We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint\* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε"||0.561|-5.915|
71693222|NCT01261390|142901465|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|99.0||||0.003|TWO_SIDED||||||Mixed Models Analysis|Adjusted for intervention and study duration (number of nights), and randomization (CVD; site; diagnostic sleep study type; PAP device type).|Estimated value is minutes of use per night.|We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).||||0.003
71693223|NCT04346199|142901537|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.758|||||TWO_SIDED|95.0|0.323|1.722||P-value not generated.|Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.722|0.323|
71693224|NCT04346199|142901545|OTHER|No formal hypothesis testing for this endpoint.|Hazard Ratio (HR)|0.967||||||95.0|0.69|1.353|||Regression, Cox|Adjusting for age (\<65 vs \>=65 years) and comorbidities (present vs absent). Ties handled by Efron approach. HR CI using profile likelihood approach.||||1.353|0.690|
71693225|NCT03066830|142901548|SUPERIORITY||Difference in Least Square (LS) Mean|-0.76|STANDARD_ERROR_OF_MEAN|0.095|<|0.0001|TWO_SIDED|95.0|-0.946|-0.574|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate.||-0.574|-0.946|< 0.0001
71693226|NCT03066830|142901549|SUPERIORITY||Difference in LS Means|-1.608|STANDARD_ERROR_OF_MEAN|0.286|<|0.0001|TWO_SIDED|95.0|-2.1685|-1.0471|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline fasting plasma glucose as a covariate.||-1.0471|-2.1685|< 0.0001
71693227|NCT03066830|142901550|SUPERIORITY||Difference in LS Means|-0.82|STANDARD_ERROR_OF_MEAN|1.272||0.5172|TWO_SIDED|95.0|-3.316|1.669|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening and country as fixed effects, and baseline SBP as a covariate.||1.669|-3.316|0.5172
71693228|NCT03066830|142901551|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|0.983||0.2994|TWO_SIDED|95.0|-2.946|0.907|||ANCOVA|||The change from baseline to Week 12 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥ 30 mmHg) at screening, and country as fixed effects, and baseline SBP as a covariate.||0.907|-2.946|0.2994
71938942|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.11||0.0993|TWO_SIDED|95.0|-0.4|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.4|0.0993
71938943|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.11||0.0002|TWO_SIDED|95.0|-0.6|-0.2||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15||-0.2|-0.6|0.0002
71938944|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0056|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21||-0.1|-0.5|0.0056
71938945|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0122|TWO_SIDED|95.0|-0.5|-0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45||-0.1|-0.5|0.0122
71938946|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.1305|TWO_SIDED|95.0|-0.3|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.3|0.1305
71938947|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.09||0.6638|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8||0.1|-0.2|0.6638
71938948|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.08||0.4341|TWO_SIDED|95.0|-0.2|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15||0.1|-0.2|0.4341
71938949|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.07||0.9085|TWO_SIDED|95.0|-0.1|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21||0.1|-0.1|0.9085
71938950|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.09||0.182|TWO_SIDED|95.0|-0.3|0.1||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45||0.1|-0.3|0.1820
71938951|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.1593|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 3||0.0|-0.1|0.1593
71938952|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.03||0.6555|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 8||0.0|-0.1|0.6555
71938953|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.017|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 15||0.0|-0.1|0.0170
71938954|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.03||0.0188|TWO_SIDED|95.0|-0.1|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 21||0.0|-0.1|0.0188
71938955|NCT02978326|143398395|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.05||0.0726|TWO_SIDED|95.0|-0.2|0.0||MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Insight: Change From Baseline in HAM-D Individual Item Score at Day 45||0.0|-0.2|0.0726
71938956|NCT02978326|143398396|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.72||0.0791|TWO_SIDED|95.0|-6.5|0.4||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 3||0.4|-6.5|0.0791
71938957|NCT02978326|143398396|SUPERIORITY||LS Mean Difference|-4.0|STANDARD_ERROR_OF_MEAN|1.86||0.0322|TWO_SIDED|1.86|-7.7|-0.3||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 8||-0.3|-7.7|0.0322
71938958|NCT02978326|143398396|SUPERIORITY||LS Mean Difference|-4.6|STANDARD_ERROR_OF_MEAN|1.91||0.018|TWO_SIDED|95.0|-8.3|-0.8||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change From Baseline in MADRS Total Score at Day 15||-0.8|-8.3|0.0180
71938959|NCT02978326|143398396|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|1.92||0.0271|TWO_SIDED|95.0|-8.1|-0.5||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 21||-0.5|-8.1|0.0271
71938960|NCT02978326|143398396|SUPERIORITY||LS Mean Difference|-5.8|STANDARD_ERROR_OF_MEAN|1.82||0.0018|TWO_SIDED|95.0|-9.4|-2.2||MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in MADRS Total Score at 45||-2.2|-9.4|0.0018
71938961|NCT02978326|143398397|SUPERIORITY||Odds Ratio (OR)|1.4||||0.3372|TWO_SIDED|95.0|0.7|2.81||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 3||2.81|0.70|0.3372
71938962|NCT02978326|143398397|SUPERIORITY||Odds Ratio (OR)|1.77||||0.0935|TWO_SIDED|95.0|0.91|3.47||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 8||3.47|0.91|0.0935
71938963|NCT02978326|143398397|SUPERIORITY||Odds Ratio (OR)|2.16||||0.0276|TWO_SIDED|95.0|1.09|4.28||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 15||4.28|1.09|0.0276
71938964|NCT02978326|143398397|SUPERIORITY||Odds Ratio (OR)|1.79||||0.092|TWO_SIDED|95.0|0.91|3.54||Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 21||3.54|0.91|0.0920
71938965|NCT02978326|143398397|SUPERIORITY||Odds Ratio (OR)|1.76||||0.1109|TWO_SIDED|95.0|0.88|3.51||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With CGI-I Response at Day 45||3.51|0.88|0.1109
71938966|NCT02978326|143398398|SUPERIORITY||LS Mean Difference|-3.1|STANDARD_ERROR_OF_MEAN|1.29||0.0169|TWO_SIDED|95.0|-5.7|-0.6||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 3||-0.6|-5.7|0.0169
71938967|NCT02978326|143398398|SUPERIORITY||LS Mean Difference|-4.4|STANDARD_ERROR_OF_MEAN|1.32||0.001|TWO_SIDED|95.0|-7.0|-1.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 8||-1.8|-7.0|0.0010
71938968|NCT02978326|143398398|SUPERIORITY||LS Mean Difference|-3.9|STANDARD_ERROR_OF_MEAN|1.41||0.0063|TWO_SIDED|95.0|-6.7|-1.1||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 15||-1.1|-6.7|0.0063
71938969|NCT02978326|143398398|SUPERIORITY||LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.37||0.0119|TWO_SIDED|95.0|-6.2|-0.8||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 21||-0.8|-6.2|0.0119
71938970|NCT02978326|143398398|SUPERIORITY||LS Mean Difference|-5.0|STANDARD_ERROR_OF_MEAN|1.28||0.0002|TWO_SIDED|95.0|-7.5|-2.4||MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.|Mixed Model for Repeated Measures|||Change from Baseline in HAM-A Total Score at Day 45||-2.4|-7.5|0.0002
71938971|NCT02978326|143398399|SUPERIORITY||Odds Ratio (OR)|1.75||||0.1145|TWO_SIDED|95.0|0.87|3.53||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 3||3.53|0.87|0.1145
71938972|NCT02978326|143398399|SUPERIORITY||Odds Ratio (OR)|1.71||||0.1069|TWO_SIDED|95.0|0.89|3.3||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 8||3.30|0.89|0.1069
71938973|NCT02978326|143398399|SUPERIORITY||Odds Ratio (OR)|2.67||||0.0045|TWO_SIDED|95.0|1.36|5.27||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 15||5.27|1.36|0.0045
71938974|NCT02978326|143398399|SUPERIORITY||Odds Ratio (OR)|2.01||||0.0421|TWO_SIDED|95.0|1.03|3.93||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 21||3.93|1.03|0.0421
71938975|NCT02978326|143398399|SUPERIORITY||Odds Ratio (OR)|1.99||||0.0541|TWO_SIDED|95.0|0.99|4.03||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Response at Day 45||4.03|0.99|0.0541
71938976|NCT02978326|143398400|SUPERIORITY||Odds Ratio (OR)|2.84||||0.0326|TWO_SIDED|95.0|1.09|7.38||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 3||7.38|1.09|0.0326
71938977|NCT02978326|143398400|SUPERIORITY||Odds Ratio (OR)|1.38||||0.3749|TWO_SIDED|95.0|0.68|2.79||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 8||2.79|0.68|0.3749
71938978|NCT02978326|143398400|SUPERIORITY||Odds Ratio (OR)|2.49||||0.0087|TWO_SIDED|95.0|1.26|4.92||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 15||4.92|1.26|0.0087
71938979|NCT02978326|143398400|SUPERIORITY||Odds Ratio (OR)|2.18||||0.0257|TWO_SIDED|95.0|1.1|4.31||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 21||4.31|1.10|0.0257
71938980|NCT02978326|143398400|SUPERIORITY||Odds Ratio (OR)|2.08||||0.0339|TWO_SIDED|95.0|1.06|4.09||Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.|GEE for binary response model|||Percentage of Participants With MADRS Remission at Day 45||4.09|1.06|0.0339
71938981|NCT02566135|143398415|OTHER||Risk Ratio (RR)|1.4628||||0.5033|TWO_SIDED|95.0|0.6401|3.3428|||Chi-squared, Corrected|||Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.||3.3428|0.6401|0.5033
71938982|NCT02566135|143398416|OTHER||Risk Ratio (RR)|0.8972|||>|0.05|TWO_SIDED|95.0|0.4858|1.6569|||Chi-squared, Corrected|||We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.||1.6569|0.4858|>0.05
71938983|NCT02566135|143398417|OTHER||||||>|0.05|||||||Chi-squared, Corrected|||||||>0.05
71938984|NCT02566135|143398418|OTHER|||||||0.44|||||||t-test, 2 sided|||Heart rate beats per minute measured at base line among the group I and group C.||||0.44
71938985|NCT02566135|143398418|OTHER|||||||0.58|||||||t-test, 2 sided|||Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.||||0.58
71938986|NCT02566135|143398418|OTHER|||||||0.16|||||||t-test, 2 sided|||Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.||||0.16
71938987|NCT02566135|143398418|OTHER|||||||0.22|||||||t-test, 2 sided|||Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.||||0.22
71938988|NCT02566135|143398418|OTHER|||||||0.059|||||||t-test, 2 sided|||Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.||||0.059
71938989|NCT02566135|143398418|OTHER||||||>|0.33|||||||t-test, 2 sided|||Heart rate beats per minute measured at endotracheal intubation among the group I and group C.||||>0.33
71938990|NCT02566135|143398418|OTHER|||||||0.63|||||||t-test, 2 sided|||Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.||||0.63
71938991|NCT02566135|143398418|OTHER|||||||0.29|||||||t-test, 2 sided|||Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.||||0.29
71938992|NCT02566135|143398418|OTHER|||||||0.18|||||||t-test, 2 sided|||Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.||||0.18
71938993|NCT02566135|143398418|OTHER|||||||0.98|||||||t-test, 2 sided|||Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.||||0.98
71938994|NCT02566135|143398418|OTHER|||||||0.49|||||||t-test, 2 sided|||Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.||||0.49
71938995|NCT02566135|143398419|OTHER|||||||0.24|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at base line between group I and group C.||||0.24
71938996|NCT02566135|143398419|OTHER|||||||0.11|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.11
71938997|NCT02566135|143398419|OTHER|||||||0.07|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.||||0.07
71938998|NCT02566135|143398419|OTHER|||||||0.85|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.85
71938999|NCT02566135|143398419|OTHER|||||||0.055|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.055
71939000|NCT02566135|143398419|OTHER|||||||0.71|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at ETT insertion time between group I and group C.||||0.71
71939001|NCT02566135|143398419|OTHER|||||||0.2|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.||||0.20
71939002|NCT02566135|143398419|OTHER|||||||0.86|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.||||0.86
71939003|NCT02566135|143398419|OTHER|||||||0.68|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.||||0.68
71939004|NCT02566135|143398419|OTHER|||||||0.98|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.||||0.98
71939005|NCT02566135|143398419|OTHER|||||||0.49|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.||||0.49
71939006|NCT02566135|143398420|OTHER|||||||0.34|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared at base line between group I and group C.||||0.34
71939007|NCT02566135|143398420|OTHER|||||||0.27|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.||||0.27
71939008|NCT02566135|143398420|OTHER|||||||0.22|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.||||0.22
71939009|NCT02566135|143398420|OTHER|||||||0.96|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.||||0.96
71939010|NCT02566135|143398420|OTHER|||||||0.71|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.||||0.71
71939011|NCT02566135|143398420|OTHER|||||||0.55|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.||||0.55
71939012|NCT02566135|143398420|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.||||0.49
71939013|NCT02566135|143398420|OTHER|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.||||0.49
71939014|NCT02566135|143398420|OTHER|||||||0.76|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.||||0.76
71939015|NCT02566135|143398420|OTHER|||||||0.69|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.||||0.69
71939016|NCT02566135|143398420|OTHER|||||||0.81|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.||||0.81
71939017|NCT02566135|143398421|OTHER||||||<|0.0001|||||||t-test, 2 sided|||We had compared time of insertion for supraglottic airway between group I and group C.||||<0.0001
71939018|NCT02566135|143398422|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71939019|NCT00947427|143398423|SUPERIORITY_OR_OTHER_LEGACY|||||||0.86|||||||ANCOVA|||||||0.86
71939020|NCT01937364|143398431|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.4||||0.0334|TWO_SIDED|90.0|-0.7275|-0.0206||One-sided p-value|z-statistic with pooled estimate||RD = Baclofen - Placebo|||-0.0206|-0.7275|0.0334
71939021|NCT01937364|143398432|SUPERIORITY_OR_OTHER|||||||0.3744|||||||Mixed Models Analysis|||Baclofen - Placebo; 24 hours||||0.3744
71939022|NCT01937364|143398432|SUPERIORITY_OR_OTHER|||||||0.7616|||||||Mixed Models Analysis|||Baclofen - Placebo; 48 hours||||0.7616
71939023|NCT01937364|143398432|SUPERIORITY_OR_OTHER|||||||0.1393|||||||Mixed Models Analysis|||Baclofen - Placebo; 72 hours||||0.1393
71939024|NCT01937364|143398433|SUPERIORITY_OR_OTHER|||||||0.33||||||Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose|Wilcoxon (Mann-Whitney)|||||||0.33
71939025|NCT01937364|143398433|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Baclofen - Placebo; Total Ativan 1mg PO equivalent dose||||0.80
71939026|NCT00936975|143398434|SUPERIORITY_OR_OTHER||Slope|-6.6084|STANDARD_ERROR_OF_MEAN|1.7644|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE||GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|This was an exploratory study and no a priori assumptions were employed.||||<0.001
71939027|NCT00936975|143398435|SUPERIORITY_OR_OTHER||Slope|-0.0115|STANDARD_ERROR_OF_MEAN|0.0089||0.1945|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.||||0.1945
71939028|NCT00936975|143398436|SUPERIORITY_OR_OTHER||Slope|0.33|STANDARD_ERROR_OF_MEAN|0.3274||0.32|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.32
71939029|NCT00936975|143398436|SUPERIORITY_OR_OTHER||Slope|6.98|STANDARD_ERROR_OF_MEAN|1.6943|<|0.001|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: No difference in uptake b/w normal \& tumor bones||||<0.001
71939030|NCT00936975|143398437|SUPERIORITY_OR_OTHER||Slope|-0.0177|STANDARD_ERROR_OF_MEAN|0.0125||0.16|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.16
71939031|NCT00936975|143398438|SUPERIORITY_OR_OTHER||Slope|0.0017|STANDARD_ERROR_OF_MEAN|0.0027||0.53|TWO_SIDED||||||Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.53
71939032|NCT00936975|143398438|SUPERIORITY_OR_OTHER||Slope|0.0205|STANDARD_ERROR_OF_MEAN|0.0128||0.1095|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: influx(Ki) is the same in normal and tumor bones||||0.1095
71939033|NCT00936975|143398439|SUPERIORITY_OR_OTHER||Slope|0.0061|STANDARD_ERROR_OF_MEAN|0.0021||0.0033|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|||||0.0033
71939034|NCT00936975|143398439|SUPERIORITY_OR_OTHER||Slope|0.0177|STANDARD_ERROR_OF_MEAN|0.0097||0.067|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones||||0.0670
71939035|NCT00936975|143398439|SUPERIORITY_OR_OTHER||Slope|32.3288|STANDARD_ERROR_OF_MEAN|14.6956||0.0278|TWO_SIDED|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations||Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones||||0.0278
71693229|NCT03066830|142901552|SUPERIORITY||Difference in LS Means|-1.41|STANDARD_ERROR_OF_MEAN|0.267|<|0.0001|TWO_SIDED|95.0|-1.932|-0.884|||ANCOVA|||The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of Metformin use at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline weight as a covariate.||-0.884|-1.932|< 0.0001
71693230|NCT03066830|142901553|SUPERIORITY||Percentage difference|6.7||||0.0004|TWO_SIDED|95.0|3.03|10.47|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤ 8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130,≥130 mmHg) at screening, randomization strata of metformin use at the screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||10.47|3.03|0.0004
71939036|NCT02974153|143398447|SUPERIORITY||Mean Difference (Final Values)|-2.6|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-3.45|-1.74|||ANCOVA|||||-1.74|-3.45|<0.0001
71939037|NCT02974153|143398447|SUPERIORITY||Mean Difference (Final Values)|-2.03|STANDARD_DEVIATION|6.15|<|0.0001|TWO_SIDED|95.0|-2.88|-1.18|||ANCOVA|||||-1.18|-2.88|<0.0001
71939038|NCT02974153|143398448|SUPERIORITY||Mean Difference (Final Values)|18.1|||<|0.0001|TWO_SIDED|95.0|12.0|24.3|||Cochran-Mantel-Haenszel|||||24.3|12.0|<0.0001
71939039|NCT02974153|143398448|SUPERIORITY||Mean Difference (Final Values)|11.7||||0.0001|TWO_SIDED|95.0|5.8|17.5|||Cochran-Mantel-Haenszel|||||17.5|5.8|0.0001
71939040|NCT02974153|143398449|SUPERIORITY||Mean Difference (Final Values)|21.3|||<|0.0001|TWO_SIDED|95.0|15.0|27.6|||Cochran-Mantel-Haenszel|||||27.6|15.0|<0.0001
71939041|NCT02974153|143398449|SUPERIORITY||Mean Difference (Final Values)|15.3|||<|0.0001|TWO_SIDED|95.0|9.3|21.4|||Cochran-Mantel-Haenszel|||||21.4|9.3|<0.0001
71939042|NCT02974153|143398450|SUPERIORITY||Mean Difference (Final Values)|22.1|||<|0.0001|TWO_SIDED|95.0|14.9|29.2|||Cochran-Mantel-Haenszel|||||29.2|14.9|<0.0001
71939043|NCT02974153|143398450|SUPERIORITY||Mean Difference (Final Values)|18.2|||<|0.0001|TWO_SIDED|95.0|11.1|25.4|||Cochran-Mantel-Haenszel|||||25.4|11.1|<0.0001
71939044|NCT02974153|143398451|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71939045|NCT02974153|143398451|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71939046|NCT02974153|143398452|SUPERIORITY||Mean Difference (Final Values)|-1.38|||<|0.0001|TWO_SIDED|95.0|-1.88|-0.87|||ANCOVA|||||-0.87|-1.88|<0.0001
71939047|NCT02974153|143398452|SUPERIORITY||Mean Difference (Final Values)|-1.15|||<|0.0001|TWO_SIDED|95.0|-1.66|-0.65|||ANCOVA|||||-0.65|-1.66|<0.0001
71939048|NCT02974153|143398453|SUPERIORITY||Mean Difference (Final Values)|-2.88|||<|0.0001|TWO_SIDED|95.0|-3.91|-1.84|||ANCOVA|||||-1.84|-3.91|<0.0001
71939049|NCT02974153|143398453|SUPERIORITY||Mean Difference (Final Values)|-1.73||||0.001|TWO_SIDED|95.0|-2.76|-0.7|||ANCOVA|||||-0.70|-2.76|0.0010
71939050|NCT02974153|143398454|SUPERIORITY||Mean Difference (Final Values)|-11.0|||<|0.0001|TWO_SIDED|95.0|-14.22|-7.77|||Repeated Measures Model|||||-7.77|-14.22|<0.0001
71939051|NCT02974153|143398454|SUPERIORITY||Mean Difference (Final Values)|-8.26|||<|0.0001|TWO_SIDED|95.0|-11.48|-5.05|||Repeated Measures Model|||||-5.05|-11.48|<0.0001
71939052|NCT02277769|143398474|SUPERIORITY||difference in percentages|27.6|||<|0.0001|TWO_SIDED|95.0|20.46|34.69||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.69|20.46|< 0.0001
71939053|NCT02277769|143398474|SUPERIORITY||difference in percentages|27.9|||<|0.0001|TWO_SIDED|95.0|20.87|34.99||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||34.99|20.87|< 0.0001
71939054|NCT02277769|143398475|SUPERIORITY||difference in percentages|32.3|||<|0.0001|TWO_SIDED|95.0|24.75|39.94||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||39.94|24.75|< 0.0001
71939055|NCT02277769|143398475|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.69|43.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.||43.81|28.69|< 0.0001
71939056|NCT02277769|143398476|SUPERIORITY||difference in percentages|26.5|||<|0.0001|TWO_SIDED|95.0|19.13|33.87||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||33.87|19.13|< 0.0001
71939057|NCT02277769|143398476|SUPERIORITY||difference in percentages|29.5|||<|0.0001|TWO_SIDED|95.0|22.11|36.95||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||36.95|22.11|< 0.0001
71939058|NCT02277769|143398477|SUPERIORITY||difference in percentages|37.8|||<|0.0001|TWO_SIDED|95.0|30.03|45.6||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||45.60|30.03|< 0.0001
71939059|NCT02277769|143398477|SUPERIORITY||difference in percentages|36.3|||<|0.0001|TWO_SIDED|95.0|28.56|44.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||44.06|28.56|< 0.0001
71939060|NCT02277769|143398478|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-36.04|-21.83||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.83|-36.04|< 0.0001
71939061|NCT02277769|143398478|SUPERIORITY||Least square (LS) mean difference|-32.8|||<|0.0001|TWO_SIDED|95.0|-40.2|-25.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.49|-40.20|< 0.0001
71939062|NCT02277769|143398479|SUPERIORITY||difference in percentages|16.3|||<|0.0001|TWO_SIDED|95.0|9.99|22.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||22.68|9.99|< 0.0001
71939063|NCT02277769|143398479|SUPERIORITY||difference in percentages|21.3|||<|0.0001|TWO_SIDED|95.0|14.66|27.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||27.93|14.66|< 0.0001
71939064|NCT02277769|143398480|SUPERIORITY||difference in percentages|9.8|||<|0.0001|TWO_SIDED|95.0|5.54|13.98||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||13.98|5.54|< 0.0001
71939065|NCT02277769|143398480|SUPERIORITY||difference in percentages|11.8|||<|0.0001|TWO_SIDED|95.0|7.31|16.32||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||16.32|7.31|< 0.0001
71939066|NCT02277769|143398481|SUPERIORITY||LS mean difference|-2.1|||<|0.0001|TWO_SIDED|95.0|-2.605|-1.587||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.587|-2.605|< 0.0001
71939067|NCT02277769|143398481|SUPERIORITY||LS mean difference|-2.47|||<|0.0001|TWO_SIDED|95.0|-2.982|-1.957||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-1.957|-2.982|< 0.0001
71761113|NCT01039376|143023892|SUPERIORITY||Mean Difference (Final Values)|-3.58||||0.0642|TWO_SIDED|95.0|-7.37|0.21||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Future Health Scale|||0.21|-7.37|0.0642
71939068|NCT02277769|143398482|SUPERIORITY||LS mean difference|-36.2|||<|0.0001|TWO_SIDED|95.0|-43.46|-28.86|||ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-28.86|-43.46|< 0.0001
71693231|NCT03066830|142901554|SUPERIORITY||Percentage difference|17.4|||<|0.0001|TWO_SIDED|95.0|11.16|23.73|||Cochran-Mantel-Haenszel|||Percentage difference between treatment groups using the Cochran-Mantel-Haenszel test stratified by the randomization strata of HbA1c (≤8.5, \>8.5%) at screening, randomization strata of mean SBP (\<130, ≥130 mmHg) at screening, randomization strata of Metformin use at screening. Missing data at Week 26 were assigned a status of non-responder in the analysis.||23.73|11.16|< 0.0001
71693232|NCT05404711|142901694|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71693233|NCT05404711|142901695|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71693234|NCT05404711|142901696|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71693235|NCT05404711|142901697|OTHER||AUC|0.56|||||TWO_SIDED|95.0|0.18|0.94|||||Area under the receiver operating characteristic curve (AUC) was 0.56 (95% CI 0.18-0.94) for 2-hour postprandial glucose.|||0.94|0.18|
71693236|NCT05404711|142901698|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71693237|NCT05404711|142901699|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71693238|NCT05404711|142901700|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71693239|NCT05404711|142901701|OTHER||AUC|1.0|||||TWO_SIDED||||||||Area under the receiver operating characteristic curve (AUC) was 1.00 (based on 100% sensitivity) for elevated fasting glucose.|||||
71939069|NCT02277769|143398482|SUPERIORITY||LS mean difference|-38.2|||<|0.0001|TWO_SIDED|95.0|-45.55|-30.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.88|-45.55|< 0.0001
71693240|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and HbA1c.||||0.3
71939070|NCT02277769|143398483|SUPERIORITY||difference in percentages|43.2|||<|0.0001|TWO_SIDED|95.0|35.12|51.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||51.29|35.12|< 0.0001
71939071|NCT02277769|143398483|SUPERIORITY||difference in percentages|39.1|||<|0.0001|TWO_SIDED|95.0|30.92|47.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||47.19|30.92|< 0.0001
71693241|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|0.5||||0.005|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and HbA1c.||||0.005
71693242|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|0.46||||0.01|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and HbA1c.||||0.01
71939072|NCT02277769|143398484|SUPERIORITY||difference in percentages|22.8|||<|0.0001|TWO_SIDED|95.0|16.09|29.59||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||29.59|16.09|< 0.0001
71939073|NCT02277769|143398484|SUPERIORITY||difference in percentages|23.3|||<|0.0001|TWO_SIDED|95.0|16.63|30.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||30.05|16.63|< 0.0001
71693243|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|0.23||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and HbA1c.||||0.2
71693244|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|0.14||||0.5|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and HbA1c.||||0.5
71693245|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|0.29||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose (mg/dL) and HbA1c.||||0.1
71693246|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM correlation of variability (CV) and HbA1c.||||0.4
71693247|NCT05404711|142901702|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.06||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation and HbA1c.||||0.7
71693248|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and laboratory-OGTT fasting glucose.||||0.2
71693249|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT fasting glucose.||||0.3
71693250|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT and lab-OGTT fasting glucose.||||0.6
71693251|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|0.19||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.3
71939074|NCT02277769|143398485|SUPERIORITY||LS mean difference|-17.99|||<|0.0001|TWO_SIDED|95.0|-22.062|-13.927||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.927|-22.062|< 0.0001
71939075|NCT02277769|143398485|SUPERIORITY||LS mean difference|-19.51|||<|0.0001|TWO_SIDED|95.0|-23.491|-15.529||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-15.529|-23.491|< 0.0001
71939076|NCT02277769|143398486|SUPERIORITY||LS mean difference|-31.4|||<|0.0001|TWO_SIDED|95.0|-37.36|-25.4||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.40|-37.36|< 0.0001
71939077|NCT02277769|143398486|SUPERIORITY||LS mean difference|-33.8|||<|0.0001|TWO_SIDED|95.0|-39.75|-27.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-27.80|-39.75|< 0.0001
71939078|NCT02277769|143398487|SUPERIORITY||LS mean difference|-5.7|||<|0.0001|TWO_SIDED|95.0|-6.86|-4.47||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.47|-6.86|< 0.0001
71939079|NCT02277769|143398487|SUPERIORITY||LS mean difference|-5.9|||<|0.0001|TWO_SIDED|95.0|-7.1|-4.72||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-4.72|-7.10|< 0.0001
71939080|NCT02277769|143398488|SUPERIORITY||LS mean difference|-7.0|||<|0.0001|TWO_SIDED|95.0|-8.36|-5.57||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-5.57|-8.36|< 0.0001
71939081|NCT02277769|143398488|SUPERIORITY||LS mean difference|-8.0|||<|0.0001|TWO_SIDED|95.0|-9.36|-6.64||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-6.64|-9.36|< 0.0001
71939082|NCT02277769|143398489|SUPERIORITY||LS mean difference|-4.2|||<|0.0001|TWO_SIDED|95.0|-5.34|-3.09||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.09|-5.34|< 0.0001
71939083|NCT02277769|143398489|SUPERIORITY||LS mean difference|-4.9|||<|0.0001|TWO_SIDED|95.0|-6.04|-3.81||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-3.81|-6.04|< 0.0001
71939084|NCT02277769|143398490|SUPERIORITY||LS mean difference|-27.7|||<|0.0001|TWO_SIDED|95.0|-33.73|-21.7||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-21.70|-33.73|< 0.0001
71939085|NCT02277769|143398490|SUPERIORITY||LS mean difference|-28.9|||<|0.0001|TWO_SIDED|95.0|-35.03|-22.74||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-22.74|-35.03|< 0.0001
71939086|NCT02277769|143398491|SUPERIORITY||LS mean difference|-17.7|||<|0.0001|TWO_SIDED|95.0|-21.96|-13.53||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-13.53|-21.96|< 0.0001
71939087|NCT02277769|143398491|SUPERIORITY||LS mean difference|-15.0|||<|0.0001|TWO_SIDED|95.0|-19.16|-10.78||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-10.78|-19.16|< 0.0001
71939088|NCT01488578|143398501|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939089|NCT01488578|143398504|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.032|TWO_SIDED||||||Chi-squared|||||||=0.032
71939090|NCT01488578|143398505|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939091|NCT01488578|143398506|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939092|NCT01488578|143398507|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939093|NCT01488578|143398508|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||The Hosmer-Lemeshow Goodness-of-Fit TEST|||||||<0.001
71939094|NCT01488578|143398510|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.006|TWO_SIDED||||||Chi-squared|||||||=0.006
71939095|NCT01488578|143398511|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939096|NCT01488578|143398512|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.015|TWO_SIDED||||||Chi-squared|||||||=0.015
71939097|NCT01488578|143398513|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939098|NCT01488578|143398514|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71939099|NCT02308111|143398516|SUPERIORITY||Hazard Ratio, log|1.01||||0.954|TWO_SIDED|95.0|0.68|1.51||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata|Log Rank|||||1.51|0.68|0.954
71939100|NCT02308111|143398517|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.304|TWO_SIDED|95.0|0.61|1.16||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.16|0.61|0.304
71939101|NCT02308111|143398518|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.898|TWO_SIDED|95.0|0.69|1.52||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.52|0.69|0.898
71939102|NCT02308111|143398519|SUPERIORITY||Hazard Ratio (HR)|1.15||||0.594|TWO_SIDED|95.0|0.69|1.91||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||1.91|0.69|0.594
71693252|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|0.09||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT fasting glucose.||||0.6
71939103|NCT02308111|143398520|SUPERIORITY||Hazard Ratio (HR)|1.26||||0.568|TWO_SIDED|95.0|0.57|2.78||Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Log Rank|||||2.78|0.57|0.568
71939104|NCT02308111|143398521|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.769|TWO_SIDED|95.0|0.59|2.07||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata.|Gray's Test|||||2.07|0.59|0.769
71939105|NCT02308111|143398522|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.599|TWO_SIDED|95.0|0.42|1.67||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.67|0.42|0.599
71939106|NCT02308111|143398523|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.745|TWO_SIDED|95.0|0.18|3.43||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.43|0.18|0.745
71939107|NCT02308111|143398524|SUPERIORITY||Hazard Ratio (HR)|0.78||||0.437|TWO_SIDED|95.0|0.43|1.44||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.44|0.43|0.437
71939108|NCT02308111|143398525|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.838|TWO_SIDED|95.0|0.37|2.24||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||2.24|0.37|0.838
71939109|NCT02308111|143398526|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.98|TWO_SIDED|95.0|0.26|4.04||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||4.04|0.26|0.980
71939110|NCT02308111|143398527|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.933|TWO_SIDED|95.0|0.58|1.83||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.83|0.58|0.933
71939111|NCT02308111|143398528|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.468|TWO_SIDED|95.0|0.53|1.34||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.34|0.53|0.468
71939112|NCT02308111|143398529|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.178|TWO_SIDED|95.0|0.13|1.41||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||1.41|0.13|0.178
71939113|NCT02308111|143398529|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.19|TWO_SIDED|95.0|0.13|1.41|||Cochran-Mantel-Haenszel|||||1.41|0.13|0.190
71939114|NCT02308111|143398530|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.443|TWO_SIDED|95.0|0.05|3.54||Gray's test p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the IWRS as strata.|Gray's Test|||||3.54|0.05|0.443
71939115|NCT03504852|143398685|SUPERIORITY||Risk Difference (RD)|17.72||||0.0003|TWO_SIDED|95.0|7.45|27.98||One-sided p-value|Regression, Logistic|||||27.98|7.45|0.0003
71939116|NCT03504852|143398685|SUPERIORITY||Odds Ratio (OR)|2.33||||0.0003|TWO_SIDED|95.0|1.44|3.78||One-sided p-value|Regression, Logistic|||||3.78|1.44|0.0003
71939117|NCT03504852|143398686|SUPERIORITY||Risk Difference (RD)|8.28||||0.0498|TWO_SIDED|95.0|-1.65|18.2||One-sided p-value|Regression, Logistic|||||18.20|-1.65|0.0498
71693253|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|0.35||||0.05|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT fasting glucose.||||0.05
71693254|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.18||||0.3|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT fasting glucose.||||0.3
71693255|NCT05404711|142901703|OTHER|Spearman correlation analysis|Spearman correlation rho|-0.07||||0.7|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT fasting glucose.||||0.7
71939118|NCT03504852|143398686|SUPERIORITY||Odds Ratio (OR)|1.51||||0.0498|TWO_SIDED|95.0|0.92|2.47||One-sided p-value|Regression, Logistic|||||2.47|0.92|0.0498
71939119|NCT02928848|143398694|OTHER|||||||0.14||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-week) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in overall language ability, as measured by the Western Aphasia Battery Aphasia Quotient (WAB-AQ), that endures over time.||||0.14
71939120|NCT02928848|143398695|OTHER|||||||0.02||||||The a priori threshold for statistical significance was p \< .05.|ANOVA|||Repeated-measures analysis of variance (RM-ANOVA) with Condition (active, sham) and time point (baseline, 0-weeks) as within-subject factors. Analysis tests whether active vs. sham stimulation confers a greater improvement in naming ability, as measured by the naming subtest of the WAB, that endures over time.||||.02
71939121|NCT01835145|143398721|SUPERIORITY|||||||0.7|||||||Chi-squared|||A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.||||0.70
71939122|NCT00582309|143398742|NON_INFERIORITY_OR_EQUIVALENCE|Original Power Analysis: The expected differences in mean blood glucose concentration between groups are \> 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.|||||<|0.05|TWO_SIDED|95.0||||All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values \< 0.05.|ANOVA|||Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher's Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher's least significant difference method.||||<0.05
71939123|NCT03482713|143398800|OTHER||Difference in least squares means|0.79|||||TWO_SIDED|95.0|-0.34|1.93|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.93|-0.34|
71939124|NCT03482713|143398801|OTHER||Difference least squares mean|0.76|||||TWO_SIDED|95.0|-0.35|1.88|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.|||1.88|-0.35|
71939125|NCT01644890|143398833|NON_INFERIORITY|The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (\<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.|Hazard Ratio (HR)|1.255|||||TWO_SIDED|95.0|0.989|1.592|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.||1.592|0.989|
71939126|NCT01644890|143398834|OTHER||Hazard Ratio (HR)|1.197|||||TWO_SIDED|95.0|0.885|1.62|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status \[(+) or (-)\], and Disease free interval (\<12 months or ≥12 months) were covariates for adjustment.|||1.620|0.885|
71939127|NCT01644890|143398835|OTHER||Difference in ORR (%)|-7.5|||||TWO_SIDED|95.0|-17.4|2.7||||||||2.7|-17.4|
71939128|NCT02761980|143398842|SUPERIORITY||LSM difference|3.14||||0.002|TWO_SIDED|95.0|1.13|5.15|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||5.15|1.13|0.002
71939129|NCT02761980|143398842|SUPERIORITY||LSM difference|0.91||||0.21|TWO_SIDED|95.0|-0.52|2.33|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.33|-0.52|0.210
71939130|NCT02761980|143398842|SUPERIORITY||LSM difference|0.79||||0.28|TWO_SIDED|95.0|-0.64|2.21|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||2.21|-0.64|0.280
71939131|NCT02761980|143398842|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.23||||0.03|TWO_SIDED|95.0|0.22|4.25|||ANCOVA|||||4.25|0.22|0.030
71939132|NCT02761980|143398842|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.35||||0.023|TWO_SIDED|95.0|0.33|4.37|||ANCOVA|||||4.37|0.33|0.023
71939133|NCT02761980|143398842|SUPERIORITY||LSM difference|-0.12||||0.864|TWO_SIDED|95.0|-1.54|1.29|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||1.29|-1.54|0.864
71939134|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.9||||0.004|TWO_SIDED|95.0|0.29|1.51|||ANCOVA|||WSTD 0-2 hours||1.51|0.29|0.004
71939135|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.39||||0.078|TWO_SIDED|95.0|-0.04|0.82|||ANCOVA|||WSTD 0-2 hours||0.82|-0.04|0.078
71939136|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.3||||0.172|TWO_SIDED|95.0|-0.13|0.74|||ANCOVA|||WSTD 0-2 hours||0.74|-0.13|0.172
71939137|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.098|TWO_SIDED|95.0|-0.1|1.13|||ANCOVA|||WSTD 0-2 hours||1.13|-0.10|0.098
71939138|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.6||||0.054|TWO_SIDED|95.0|-0.01|1.21|||ANCOVA|||WSTD 0-2 hours||1.21|-0.01|0.054
71939139|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.692|TWO_SIDED|95.0|-0.52|0.34|||ANCOVA|||WSTD 0-2 hours||0.34|-0.52|0.692
71939140|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.87|||<|0.001|TWO_SIDED|95.0|0.86|2.88|||ANCOVA|||WSTD 0-4 hours||2.88|0.86|< 0.001
71693256|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.1||||0.6|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT fasting glucose and lab-OGTT 2-hour glucose.||||0.6
71939141|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.61||||0.094|TWO_SIDED|95.0|-0.1|1.33|||ANCOVA|||WSTD 0-4 hours||1.33|-0.10|0.094
71939142|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.45||||0.217|TWO_SIDED|95.0|-0.27|1.17|||ANCOVA|||WSTD 0-4 hours||1.17|-0.27|0.217
71939143|NCT02761980|143398843|SUPERIORITY||LSM difference|1.26||||0.015|TWO_SIDED|95.0|0.24|2.27||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|ANCOVA|||WSTD 0-4 hours||2.27|0.24|0.015
71939144|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.42||||0.006|TWO_SIDED|95.0|0.4|2.44|||ANCOVA|||WSTD 0-4 hours||2.44|0.40|0.006
71693257|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT 2-hour glucose and lab-OGTT 2-hour glucose.||||0.1
71693258|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.25||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between delta (difference between fasting and postprandial) home-OGTT glucose and lab-OGTT 2-hour glucose.||||0.2
71693259|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.26||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
71693260|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.27||||0.2|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between time of home-OGTT peak glucose and lab-OGTT 2-hour glucose.||||0.2
71693261|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.31||||0.08|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM mean glucose and lab-OGTT 2-hour glucose.||||0.08
71693262|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.15||||0.4|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM coefficient of variability (CV) and lab-OGTT 2-hour glucose.||||0.4
71693263|NCT05404711|142901704|OTHER|Spearman correlation analysis|Spearman correlation rho|0.28||||0.1|TWO_SIDED||||||Spearman correlation|||Correlation analyses were performed to assess the relationship between CGM standard deviation (SD) and lab-OGTT 2-hour glucose.||||0.1
71693264|NCT00418028|142901705|NON_INFERIORITY_OR_EQUIVALENCE|"If we assume that the non-inferiority level is up to 15% lower (equivalent to a median progression-free time of 3 months), for a one-sided error α=0.05, and 80% power, are necessary 88 patients per group.~Considering an dropout rate of around 10%, the number of patients would be 98 per group."|Hazard Ratio (HR)|1.3||||0.1224|TWO_SIDED|95.0|0.9|1.7|||Log Rank|||||1.7|0.9|0.1224
71693265|NCT00418028|142901706|SUPERIORITY|||||||0.8269|||||||Chi-squared|||||||0.8269
71693266|NCT00418028|142901707|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5703|TWO_SIDED|95.0|0.67|2.07|||Log Rank|||||2.07|0.67|0.5703
71693267|NCT00418028|142901708|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.4676|TWO_SIDED|95.0|0.83|1.5|||Log Rank|||||1.50|0.83|0.4676
71693268|NCT00418028|142901709|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.5688|TWO_SIDED|95.0|0.66|1.25|||Log Rank|||||1.25|0.66|0.5688
71693269|NCT00418028|142901710|SUPERIORITY|||||||0.4984|||||||Chi-squared|||||||0.4984
71693270|NCT00418028|142901711|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.2556|TWO_SIDED|95.0|0.88|1.63|||Log Rank|||||1.63|0.88|0.2556
71693271|NCT04754542|142901733|NON_INFERIORITY|We performed a non-inferiority test for the proportions of the drug continuation and drug discontinuation arms experiencing a new MS relapse and/or MRI Brain Lesion over the course of the study duration. The non-inferiority margin used was 8%.|Difference in proportion|0.0121||||0.124|TWO_SIDED|95.0|-0.1321|0.1287|||Exact binomial test|Exact binomial test fr difference in two proportions||We tested the null hypothesis of inferiority with the proportion of disease events (i.e., new MS relapse and/or MRI brain lesion) for the drug discontinuation group being 8% greater than the proportion for the drug continuation group under the alternative that the two rates are equal.||0.1287|-0.1321|0.124
71693272|NCT04754542|142901734|SUPERIORITY|||||||0.639|||||||t-test, 2 sided|||||||0.639
71693273|NCT04754542|142901735|SUPERIORITY|||||||0.964|||||||t-test, 2 sided|||||||0.964
71693274|NCT04754542|142901736|SUPERIORITY|||||||0.819|||||||t-test, 2 sided|||||||0.819
71693275|NCT04754542|142901737|SUPERIORITY|||||||0.515|||||||t-test, 2 sided|||||||0.515
71693276|NCT04754542|142901738|SUPERIORITY|||||||0.388|||||||t-test, 2 sided|||||||0.388
71693277|NCT04754542|142901739|SUPERIORITY|||||||0.183|||||||t-test, 2 sided|||||||0.183
71693278|NCT04754542|142901740|SUPERIORITY|||||||0.414|||||||t-test, 2 sided|||||||0.414
71693279|NCT04754542|142901741|SUPERIORITY|||||||0.998|||||||t-test, 2 sided|||||||0.998
71693280|NCT04754542|142901742|SUPERIORITY|||||||0.32|||||||t-test, 2 sided|||||||0.320
71693281|NCT04754542|142901743|SUPERIORITY|||||||0.061|||||||t-test, 2 sided|||||||0.061
71693282|NCT04754542|142901744|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
71693283|NCT04754542|142901745|SUPERIORITY|||||||0.514|||||||t-test, 2 sided|||||||0.514
71693284|NCT04754542|142901746|SUPERIORITY|||||||0.017|||||||t-test, 2 sided|||||||0.017
71693285|NCT04754542|142901747|SUPERIORITY|||||||0.155|||||||t-test, 2 sided|||||||0.155
71693286|NCT04754542|142901748|SUPERIORITY|||||||0.358|||||||t-test, 2 sided|||||||0.358
71693287|NCT04754542|142901749|SUPERIORITY|||||||0.151|||||||t-test, 2 sided|||||||0.151
71693288|NCT04754542|142901750|SUPERIORITY|||||||0.123|||||||t-test, 2 sided|||||||0.123
71693289|NCT04754542|142901751|SUPERIORITY|||||||0.656|||||||Chi-squared|||||||0.656
71693290|NCT04754542|142901752|SUPERIORITY|||||||0.892|||||||Chi-squared|||||||0.892
71693291|NCT04754542|142901753|SUPERIORITY|||||||0.063|||||||Mantel Haenszel|Cochran-Mantel-Haenszel chi-square test for ordinal-nominal association was used||||||0.063
71693292|NCT01116921|142901777|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3||||0.006|TWO_SIDED|95.0|0.13|0.7|||Regression, Logistic|||||0.70|0.13|0.006
71693293|NCT00735709|142901802|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.93|||<|0.001|TWO_SIDED|95.0|-6.99|-2.86||Pre-specified sequential statistical testing procedure indicates that when p-value \<0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.||-2.86|-6.99|<0.001
71693294|NCT00735709|142901802|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.12|||<|0.001|TWO_SIDED|95.0|-6.17|-2.08||Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-2.08|-6.17|<0.001
71939145|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.16||||0.659|TWO_SIDED|95.0|-0.87|0.55|||ANCOVA|||WSTD 0-4 hours||0.55|-0.87|0.659
71939146|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.62|||<|0.001|TWO_SIDED|95.0|1.16|4.08|||ANCOVA|||WSTD 0-6 hours||4.08|1.16|< 0.001
71939147|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.79||||0.135|TWO_SIDED|95.0|-0.25|1.82|||ANCOVA|||WSTD 0-6 hours||1.82|-0.25|0.135
71939148|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.7||||0.186|TWO_SIDED|95.0|-0.34|1.74|||ANCOVA|||WSTD 0-6 hours||1.74|-0.34|0.186
71693295|NCT00735709|142901802|SUPERIORITY_OR_OTHER||LS Mean Difference|-3.52|||<|0.001|TWO_SIDED|95.0|-5.57|-1.47||This treatment arm is not in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.47|-5.57|<0.001
71939149|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.83||||0.014|TWO_SIDED|95.0|0.37|3.29|||ANCOVA|||WSTD 0-6 hours||3.29|0.37|0.014
71693296|NCT00735709|142901803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.54||||0.135|TWO_SIDED|95.0|-3.56|0.48||Pre-specified sequential statistical testing procedure indicates that when p-value \>0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.48|-3.56|0.135
71693297|NCT00735709|142901803|SUPERIORITY_OR_OTHER||LS Mean Difference|-1.11||||0.263|TWO_SIDED|95.0|-3.07|0.84|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||0.84|-3.07|0.263
71693298|NCT00735709|142901803|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.05||||0.963|TWO_SIDED|95.0|-2.03|1.94|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||1.94|-2.03|0.963
71693299|NCT00735709|142901804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.55|||<|0.001|TWO_SIDED|95.0|-0.8|-0.3|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.30|-0.80|<0.001
71693300|NCT00735709|142901804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.71|-0.22|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.22|-0.71|<0.001
71693301|NCT00735709|142901804|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.47|||<|0.001|TWO_SIDED|95.0|-0.72|-0.23|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-0.23|-0.72|<0.001
71939150|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.92||||0.011|TWO_SIDED|95.0|0.45|3.39|||ANCOVA|||WSTD 0-6 hours||3.39|0.45|0.011
71939151|NCT02761980|143398843|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.865|TWO_SIDED|95.0|-1.12|0.94|||ANCOVA|||WSTD 0-6 hours||0.94|-1.12|0.865
71939152|NCT02761980|143398844|SUPERIORITY|||||||0.449||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.449
71939153|NCT02761980|143398844|SUPERIORITY|||||||0.142||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.142
71939154|NCT02761980|143398844|SUPERIORITY|||||||0.822||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.822
71939155|NCT02761980|143398844|SUPERIORITY|||||||0.671||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.671
71939156|NCT02761980|143398844|SUPERIORITY|||||||0.514||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.514
71939157|NCT02761980|143398844|SUPERIORITY|||||||0.191||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank|||||||0.191
71939158|NCT02761980|143398845|SUPERIORITY|||||||0.997||||||P-value, hazard ratio (HR) and corresponding 95% CI were calculated based on the proportional hazards (PH) model with treatment term in the model.|hazard ratio|||||||0.997
71939159|NCT02761980|143398845|SUPERIORITY|||||||0.998||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.998
71693302|NCT00735709|142901805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.348|||<|0.001|TWO_SIDED|95.0|1.995|5.618|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo.|||5.618|1.995|<0.001
71693303|NCT00735709|142901805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.739|||<|0.001|TWO_SIDED|95.0|1.631|4.598|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||4.598|1.631|<0.001
71693304|NCT00735709|142901805|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.018|||<|0.001|TWO_SIDED|95.0|1.799|5.063|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo|||5.063|1.799|<0.001
71693305|NCT00735709|142901806|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.59||||0.001|TWO_SIDED|95.0|-7.34|-1.84|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.84|-7.34|0.001
71939160|NCT02761980|143398845|SUPERIORITY|||||||0.997||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio|||||||0.997
71939161|NCT02761980|143398846|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.67||||0.101|TWO_SIDED|95.0|-0.13|1.48|||ANCOVA|||||1.48|-0.13|0.101
71939162|NCT02761980|143398846|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.16||||0.582|TWO_SIDED|95.0|-0.41|0.73|||ANCOVA|||||0.73|-0.41|0.582
71939163|NCT02761980|143398846|SUPERIORITY||LSM difference|0.15||||0.614|TWO_SIDED|95.0|-0.43|0.72|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.||0.72|-0.43|0.614
71939164|NCT02761980|143398846|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.212|TWO_SIDED|95.0|-0.29|1.32|||ANCOVA|||||1.32|-0.29|0.212
71939165|NCT02761980|143398846|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.53||||0.202|TWO_SIDED|95.0|-0.28|1.34|||ANCOVA|||||1.34|-0.28|0.202
71939166|NCT02761980|143398846|SUPERIORITY|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.01||||0.965|TWO_SIDED|95.0|-0.58|0.55|||ANCOVA|||||0.55|-0.58|0.965
71939167|NCT00101582|143398848|SUPERIORITY_OR_OTHER||Chi-Square Statistic|4.1764||||0.041||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.||||0.0410
71693306|NCT00735709|142901806|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.47||||0.002|TWO_SIDED|95.0|-7.32|-1.62|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.62|-7.32|0.002
71693307|NCT00735709|142901806|SUPERIORITY_OR_OTHER||LS Mean Difference|-4.13||||0.004|TWO_SIDED|95.0|-6.9|-1.37|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||||-1.37|-6.90|0.004
71939168|NCT00101582|143398849|SUPERIORITY_OR_OTHER||Chi-Square Statistic|5.8002||||0.016||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0160
71939169|NCT00101582|143398849|SUPERIORITY_OR_OTHER|||||||0.1122||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.||||0.1122
71939170|NCT00101582|143398850|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6603||||0.0261|TWO_SIDED|95.0|0.4546|0.9592|||Stratified Log-Rank test|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.|||0.9592|0.4546|0.0261
71939171|NCT00101582|143398850|SUPERIORITY_OR_OTHER|||||||0.1566||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Stratified Log-Rank test|||||||0.1566
71939172|NCT00101582|143398851|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.9715||||0.0463||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0463
71939173|NCT00101582|143398851|SUPERIORITY_OR_OTHER|||||||0.2314||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2314
71693308|NCT00735709|142901807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.951||||0.026|TWO_SIDED|95.0|1.082|3.517|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.517|1.082|0.026
71939174|NCT00101582|143398852|SUPERIORITY_OR_OTHER||Chi-Square Statistic|3.2548||||0.0712||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.0712
71939175|NCT00101582|143398852|SUPERIORITY_OR_OTHER|||||||0.2849||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.2849
71939176|NCT00101582|143398853|SUPERIORITY_OR_OTHER||Chi-Square Statistic|1.3901||||0.2384||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.2384
71939177|NCT00101582|143398853|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
71939178|NCT00101582|143398854|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.9039||||0.3417||95.0||||Generalized Cochran-Mantel-Haenszel test for general association|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.3417
71939179|NCT00101582|143398854|SUPERIORITY_OR_OTHER|||||||0.6835||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.6835
71939180|NCT00101582|143398855|SUPERIORITY_OR_OTHER||Chi-Square Statistic|0.0027||||0.9587||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||||||0.9587
71939181|NCT00101582|143398855|SUPERIORITY_OR_OTHER|||||||0.9587||95.0||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||||||0.9587
71939182|NCT03093324|143398875|SUPERIORITY||Rate ratio|0.542||||0.0003|TWO_SIDED|95.0|0.39|0.754|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.754|0.390|0.0003
71693309|NCT00735709|142901807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.056||||0.015|TWO_SIDED|95.0|1.15|3.673|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.673|1.150|0.015
71939183|NCT03093324|143398876|SUPERIORITY||Rate ratio|0.52||||0.0007|TWO_SIDED|95.0|0.356|0.76|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.760|0.356|0.0007
71939184|NCT03093324|143398877|SUPERIORITY||Rate ratio|0.714||||0.009|TWO_SIDED|95.0|0.554|0.921|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.921|0.554|0.009
71939185|NCT03093324|143398878|SUPERIORITY||Rate ratio|0.555||||0.009|TWO_SIDED|95.0|0.357|0.862|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.862|0.357|0.009
71693310|NCT00735709|142901807|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.753||||0.062|TWO_SIDED|95.0|0.973|3.158|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.||||3.158|0.973|0.062
71693311|NCT02492802|142901828|OTHER|||||||0.77|||||||The Wald Type III test|||||||0.77
71693312|NCT01165307|142901829|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||||||0.003
71693313|NCT01165307|142901830|SUPERIORITY_OR_OTHER|||||||0.82|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 Physical Scale.||||0.82
71939186|NCT03093324|143398879|SUPERIORITY||Rate ratio|0.696||||0.033|TWO_SIDED|95.0|0.499|0.972|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||0.972|0.499|0.033
71939187|NCT03093324|143398880|SUPERIORITY||Rate ratio|0.662||||0.068|TWO_SIDED|95.0|0.425|1.031|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.031|0.425|0.068
71939188|NCT03093324|143398881|SUPERIORITY||Rate ratio|0.713||||0.215|TWO_SIDED|95.0|0.417|1.217|||Negative Binomial Regression Model|||Number of event days was analyzed by a negative binomial regression model, with the logarithmic transformation of the number of exposure days as the ''offset'' parameter and treatment group as a factor and adjusting for study part, region (US and non-US), age, and body mass index (BMI).||1.217|0.417|0.215
71939189|NCT03093324|143398882|SUPERIORITY||Least Squares Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.16||0.043|TWO_SIDED|95.0|-0.6|0.0|||ANCOVA|||Nausea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.0|-0.6|0.043
71939190|NCT03093324|143398882|SUPERIORITY||Least Squares Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.12|<|0.001|TWO_SIDED|95.0|-0.7|-0.2|||ANCOVA|||Vomiting: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.7|<0.001
71939191|NCT03093324|143398882|SUPERIORITY||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.16||0.001|TWO_SIDED|95.0|-0.9|-0.2|||ANCOVA|||Upper Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||-0.2|-0.9|0.001
71939192|NCT03093324|143398882|SUPERIORITY||Least Squares Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.15||0.403|TWO_SIDED|95.0|-0.4|0.2|||ANCOVA|||Lower Abdominal Pain: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.4|0.403
71939193|NCT03093324|143398882|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.261|TWO_SIDED|95.0|-0.6|0.2|||ANCOVA|||Diarrhea: DMF is used as a referenced group in the model, adjusting for study parts, region (US and non-US), age and BMI.||0.2|-0.6|0.261
71939194|NCT04583579|143398900|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||||||0.78
71939195|NCT00976664|143398905|SUPERIORITY_OR_OTHER|||||||0.0007|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.||||||.0007
71939196|NCT00976664|143398905|SUPERIORITY_OR_OTHER|||||||0.3913|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.||||||.3913
71939197|NCT00976664|143398906|SUPERIORITY_OR_OTHER|||||||0.002|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.||||||.002
71939198|NCT00976664|143398906|SUPERIORITY_OR_OTHER|||||||0.0336|ONE_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.||||||.0336
71939199|NCT00135707|143398922|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.42|TWO_SIDED|95.0|0.91|1.25|||Chi-squared|||The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.||1.25|0.91|0.42
71939200|NCT00135707|143398923|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.79|TWO_SIDED|95.0|0.85|1.24|||Chi-squared|||||1.24|0.85|0.79
71939201|NCT00135707|143398924|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.79||||0.35|TWO_SIDED|95.0|0.47|1.31|||Chi-squared|||||1.31|0.47|0.35
71939202|NCT00135707|143398925|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.68||||0.16|TWO_SIDED|95.0|0.39|1.17|||Chi-squared|||||1.17|0.39|0.16
71939203|NCT00135707|143398926|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.63||||0.34|TWO_SIDED|95.0|0.25|1.63|||Chi-squared|||||1.63|0.25|0.34
71939204|NCT00135707|143398927|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.49||||0.11|TWO_SIDED|95.0|0.78|7.94|||Chi-squared|||||7.94|0.78|0.11
71939205|NCT00135707|143398928|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.81||||0.57|TWO_SIDED|95.0|0.39|1.68|||Chi-squared|||||1.68|0.39|0.57
71939206|NCT00135707|143398929|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.18|TWO_SIDED|95.0|0.89|1.9|||Chi-squared|||||1.90|0.89|0.18
71939207|NCT00135707|143398930|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.09||||0.84|TWO_SIDED|95.0|0.48|2.46|||Chi-squared|||||2.46|0.48|0.84
71939208|NCT00135707|143398931|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.33|TWO_SIDED|95.0|0.93|1.24|||Chi-squared|||||1.24|0.93|0.33
71939209|NCT00135707|143398932|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.1||||0.004|TWO_SIDED|95.0|1.03|1.17|||Chi-squared|||||1.17|1.03|0.004
71939210|NCT00135707|143398933|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.07||||0.25|TWO_SIDED|95.0|0.95|1.21|||Chi-squared|||||1.21|0.95|0.25
71939211|NCT00135707|143398934|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.73||||0.15||95.0|0.47|1.12|||Chi-squared|||||1.12|0.47|0.15
71939212|NCT00135707|143398935|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.51|TWO_SIDED|95.0|0.32|1.77|||Chi-squared|||||1.77|0.32|0.51
71939213|NCT00135707|143398936|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.21||||0.33|TWO_SIDED|95.0|0.82|1.79|||Chi-squared|||||1.79|0.82|0.33
71939214|NCT00135707|143398937|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.96||||0.74|TWO_SIDED|95.0|0.75|1.22|||Chi-squared|||||1.22|0.75|0.74
71939215|NCT00135707|143398938|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.12|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.40|0.12
71939216|NCT00135707|143398939|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.35|TWO_SIDED|95.0|0.97|1.11|||Chi-squared|||||1.11|0.97|0.35
71939217|NCT00135707|143398941|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.3||||0.05|TWO_SIDED|95.0|0.08|1.08|||Chi-squared|||||1.08|0.08|0.05
71939218|NCT00135707|143398942|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.67||||0.05|TWO_SIDED|95.0|0.45|1.01|||Chi-squared|||||1.01|0.45|0.05
71939219|NCT00135707|143398943|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.65
71939220|NCT00135707|143398944|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.21
71939221|NCT00135707|143398945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.97||||0.63|TWO_SIDED|95.0|0.87|1.09|||Chi-squared|||\<37 weeks' gestation||1.09|0.87|0.63
71939222|NCT00135707|143398945|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.86||||0.16|TWO_SIDED|95.0|0.69|1.06|||Chi-squared|||\<32 weeks' gestation||1.06|0.69|0.16
71939223|NCT00135707|143398946|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.92||||0.53|TWO_SIDED|95.0|0.72|1.19|||Chi-squared|||||1.19|0.72|0.53
71939224|NCT00135707|143398947|SUPERIORITY_OR_OTHER|||||||0.55||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.55
71939225|NCT00135707|143398948|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.98|TWO_SIDED|95.0|0.79|1.27|||Chi-squared|||||1.27|0.79|0.98
71939226|NCT00135707|143398949|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.93||||0.32|TWO_SIDED|95.0|0.81|1.07|||Chi-squared|||||1.07|0.81|0.32
71939227|NCT00135707|143398950|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.03||||0.58|TWO_SIDED|95.0|0.92|1.15|||Chi-squared|||||1.15|0.92|0.58
71939228|NCT00135707|143398951|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.04||||0.75|TWO_SIDED|95.0|0.83|1.3|||Chi-squared|||||1.30|0.83|0.75
71939229|NCT00135707|143398952|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.78|TWO_SIDED|95.0|0.29|2.54|||Chi-squared|||||2.54|0.29|0.78
71939230|NCT00135707|143398953|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.34|TWO_SIDED|95.0|0.76|2.23|||Chi-squared|||||2.23|0.76|0.34
71939231|NCT00135707|143398954|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.71||||0.41|TWO_SIDED|95.0|0.32|1.6|||Chi-squared|||||1.60|0.32|0.41
71939232|NCT00135707|143398955|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.18||||0.62|TWO_SIDED|95.0|0.61|2.3|||Chi-squared|||||2.30|0.61|0.62
71939233|NCT00135707|143398956|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.85||||0.56|TWO_SIDED|95.0|0.49|1.48|||Chi-squared|||||1.48|0.49|0.56
71939234|NCT00135707|143398957|SUPERIORITY_OR_OTHER|||||||0.79||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.79
71939235|NCT00135707|143398958|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.02||||0.86|TWO_SIDED|95.0|0.82|1.26|||Chi-squared|||||1.26|0.82|0.86
71939236|NCT00135707|143398959|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.12||||0.32|TWO_SIDED|95.0|0.89|1.42|||Chi-squared|||||1.42|0.89|0.32
71939237|NCT02743702|143398981|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71939238|NCT02396381|143399003|OTHER||LS Mean Difference|3.09|||<|0.001|TWO_SIDED|96.875|1.1|5.09|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of HDL-C for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||5.09|1.10|<0.001
71939239|NCT02396381|143399004|SUPERIORITY||LS Mean Difference|-0.42||||0.001|TWO_SIDED|96.875|-0.717|-0.123|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of WBC for THS-use is lower than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≥ 0.0~HA: XTHS - XCC \< 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||-0.123|-0.717|0.001
71939240|NCT02396381|143399005|SUPERIORITY||LS Mean Difference|1.28||||0.008|TWO_SIDED|96.875|0.145|2.42|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of FEV1 for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC \> 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||2.42|0.145|0.008
71939241|NCT02396381|143399006|SUPERIORITY||% Reduction|2.86||||0.03|TWO_SIDED|96.875|-0.426|6.04|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of sICAM-1 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||6.04|-0.426|0.030
71939242|NCT02396381|143399007|SUPERIORITY||% Reduction|4.74||||0.193|TWO_SIDED|96.875|-7.5|15.6|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 11-DTX-B2 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||15.6|-7.5|0.193
71939243|NCT02396381|143399008|SUPERIORITY||% Reduction|6.8||||0.018|TWO_SIDED|96.875|-0.216|13.3|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of 8-epi-PGF2α will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||13.3|-0.216|0.018
71693314|NCT01165307|142901830|SUPERIORITY_OR_OTHER|||||||0.11|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 mental scale.||||0.11
71939244|NCT02396381|143399009|SUPERIORITY||% Reduction|43.5|||<|0.001|TWO_SIDED|96.875|33.7|51.9|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis of Total NNAL will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||51.9|33.7|<0.001
71693315|NCT01165307|142901831|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71693316|NCT01165307|142901832|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||0.38
71693317|NCT01165307|142901833|SUPERIORITY_OR_OTHER|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||||||0.12
71693318|NCT01165307|142901834|SUPERIORITY_OR_OTHER|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||||||0.60
71693319|NCT01165307|142901835|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71693320|NCT01165307|142901839|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71939245|NCT02396381|143399010|SUPERIORITY||% Reduction|32.2|||<|0.001|TWO_SIDED|96.875|24.5|39.0|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 - LS Mean Ratio (THS / CC)|"The analysis will test if the mean level of COHb for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC \< 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use. H0 is rejected with a type I error α = 1.5625% (one-sided test)."||39|24.5|<0.001
71693321|NCT03150082|142901869|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.88|||||TWO_SIDED|90.0|91.13|103.0|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.00|91.13|
71693322|NCT03150082|142901870|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|93.16|||||TWO_SIDED|90.0|86.09|100.82|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||100.82|86.09|
71693323|NCT03150082|142901871|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.96|||||TWO_SIDED|90.0|91.17|103.11|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.|||103.11|91.17|
71693324|NCT03150082|142901872|EQUIVALENCE|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.||||||0.3499||||||"P value was analyzed using a nonparametric Wilcoxon signed-rank test."|Wilcoxon signed-rank test|||||||0.3499
71693325|NCT01718483|142901894|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.35|||<|0.001|TWO_SIDED|95.0|-1.7|-1.01|||Mixed Models Repeated Measures Analysis|||||-1.01|-1.70|<0.001
71693326|NCT01718483|142901895|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71693327|NCT01718483|142901896|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Chi-squared|||||||<0.001
71693328|NCT01718483|142901897|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-6.35|||<|0.001|TWO_SIDED|95.0|-7.17|-5.54|||Mixed Models Repeated Measures Analysis|||||-5.54|-7.17|<0.001
71693329|NCT01718483|142901898|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-7.4|||<|0.001|TWO_SIDED|95.0|-8.93|-5.88|||Mixed Models Repeated Measures Analysis|||||-5.88|-8.93|<0.001
71939246|NCT03679741|143399019|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|1.9|STANDARD_DEVIATION|1.99|||TWO_SIDED|95.0|-1.9|5.8|||Bayesian multivariate normal random-effe|A 95% Credible Interval for the Posterior mean difference between the Test and Control was used to test for non-inferiority.|Mean difference was calculated as test minus control|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup's Method (alpha=0.05).||5.8|-1.9|
71693330|NCT01718483|142901899|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.199|||<|0.001|TWO_SIDED|95.0|-0.31|-0.088|||ANCOVA|||||-0.088|-0.310|<0.001
71693331|NCT01718483|142901900|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.211|||<|0.001|TWO_SIDED|95.0|-0.33|-0.092|||ANCOVA|||||-0.092|-0.330|<0.001
71693332|NCT01718483|142901901|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.02||||0.308|TWO_SIDED|95.0|-0.07|0.02|||ANCOVA|||||0.02|-0.07|0.308
71693333|NCT01718483|142901902|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel|||||||<0.001
71693334|NCT01718483|142901903|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-1.77|||<|0.001|TWO_SIDED|95.0|-2.24|-1.3||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-1.30|-2.24|<0.001
71693335|NCT01718483|142901904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|1.65|||<|0.001|TWO_SIDED|95.0|0.72|2.57||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating||2.57|0.72|<0.001
71693336|NCT01718483|142901904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.19|||<|0.001|TWO_SIDED|95.0|-4.98|-3.39||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating||-3.39|-4.98|<0.001
71693337|NCT01718483|142901904|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-4.7|||<|0.001|TWO_SIDED|95.0|-5.49|-3.91||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger||-3.91|-5.49|<0.001
71693338|NCT01718483|142901905|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-10.32|||<|0.001|TWO_SIDED|95.0|-12.43|-8.21||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||||-8.21|-12.43|<0.001
71693339|NCT01718483|142901906|SUPERIORITY_OR_OTHER_LEGACY||Least squares mean difference|-0.31||||0.706|TWO_SIDED|95.0|-1.93|1.31||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA|||||1.31|-1.93|0.706
71693340|NCT00536510|142901920|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.7|STANDARD_ERROR_OF_MEAN|1.96|<|0.001||95.0|-18.6|-10.9||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The primary hypothesis of superiority of MK0524A 2 g to placebo in lowering Low Density Lipoprotein Cholesterol (LDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||-10.9|-18.6|<0.001
71693341|NCT00536510|142901921|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.9|STANDARD_ERROR_OF_MEAN|1.68|<|0.001||95.0|12.6|19.2||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The secondary hypothesis of superiority of MK0524A 2 g to placebo in lowering High Density Lipoprotein Cholesterol (HDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.||19.2|12.6|<0.001
71939247|NCT03679741|143399020|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|3.97|STANDARD_DEVIATION|1.138|||TWO_SIDED|95.0|2.27|6.62|||Bayesian multinomial random-effects mode|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||6.62|2.27|
71939248|NCT03679741|143399021|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.022|STANDARD_DEVIATION|0.0074|||TWO_SIDED|95.0|-0.037|-0.008|||Bayesian multivariate normal model|with random effects|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the low luminance high contrast lighting condition.||-0.008|-0.037|
71939249|NCT03679741|143399021|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.034|STANDARD_DEVIATION|0.0075|||TWO_SIDED|95.0|-0.049|-0.02|||Bayesian multivariate normal model|with random effect|Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup's method. The analysis presented below, summarizes the high illumination low contrast lighting condition.||-0.020|-0.049|
71939250|NCT03679741|143399022|SUPERIORITY|A superiority margin of 90% was used. Superiority was concluded if the lower limit of the 95% credible interval was above 90%|Mean Percentage of eyes|100.0|STANDARD_DEVIATION|0.002|||TWO_SIDED|95.0|99.0|100.0|||Bayesian beta- binomial model|for correlated binary data||It was calculated that 65 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.||100.0|99.0|
71939251|NCT03679741|143399023|NON_INFERIORITY|A non-inferiority cumulative odds ratio margin of 2 was used. This margin corresponds to no more than a 5% difference between the Test and Control lenses assuming the Control reference rate does not exceed 5%. Non-inferiority was declared if the upper bound of the 95% credible interval was below 2.|Mean Difference (Final Values)|0.001|STANDARD_DEVIATION|0.003|||TWO_SIDED|95.0|-0.004|0.008|||Bayesian beta-binomial hierarchical||Mean difference was calculated as Test minus Control.|It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods.||0.008|-0.004|
71939252|NCT03679741|143399024|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.6|STANDARD_DEVIATION|1.29|||TWO_SIDED|95.0|3.1|8.1|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||8.1|3.1|
71939253|NCT03679741|143399025|NON_INFERIORITY|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|2.5|STANDARD_DEVIATION|1.56|||TWO_SIDED|95.0|-0.6|5.5|||Bayesian multivariate normal model|for random effects|Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.||5.5|-0.6|
71939254|NCT03679741|143399026|NON_INFERIORITY|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|1.73|STANDARD_DEVIATION|0.459|||TWO_SIDED|95.0|1.0|2.82|||Bayesian multinomial random-effects|A 95% Credible Interval for the odds ratio, was used to test for non-inferiority.|Odds ratio was calculated as test over control|||2.82|1.00|
71939255|NCT02584140|143399051|OTHER||||||<|0.001||||||The P-Value for Week 4 was \<0.001; The P-Value for Week 12 was 0.005; The P-Value for Week 24 was 0.029; The P-Value for Week 36 was 0.008; The P-Value for Week 48 was 0.03.|Wilcoxon (Mann-Whitney)|||||||<0.001
71939256|NCT02419313|143399074|SUPERIORITY_OR_OTHER|||||||0.0007|TWO_SIDED||||||Fisher Exact|||||||0.0007
71693342|NCT00809445|142901922|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|4.52|||<|0.001|TWO_SIDED|97.5|3.57|5.72||a-prior threshold for statistical significance is .025|Cochran-Mantel-Haenszel||The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm|Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||5.72|3.57|<0.001
71693343|NCT00809445|142901923|SUPERIORITY_OR_OTHER||incidence rate raios (IRR)|1.04||||0.39|TWO_SIDED|97.5|0.95|1.14||a-priori threshold for statistical significance is .025|generalized estimating equations (GEE)||Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group|Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.||1.14|0.95|0.39
71693344|NCT00809445|142901923|SUPERIORITY_OR_OTHER||Incidence rate ratio (IRR)|1.03||||0.81|TWO_SIDED|97.5|0.84|1.26||a-priori threshold for statistical significance is .025|Generalized estimating equations (GEE)||Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm|"The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group"||1.26|0.84|0.81
71693345|NCT00809445|142901924|SUPERIORITY_OR_OTHER|||||||0.044||||||a priori threshold for significance was .05|Chi-squared|Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles||||||0.044
71693346|NCT00809445|142901925|SUPERIORITY_OR_OTHER||||||<|0.0001||||||a-priori threshold for statistical significance is .05|Chi-squared|chi-square = 428.2466, Df=2||||||<0.0001
71939257|NCT02419313|143399075|SUPERIORITY_OR_OTHER|||||||0.0008|TWO_SIDED||||||Fisher Exact|||||||0.0008
71939258|NCT02419313|143399076|SUPERIORITY_OR_OTHER|||||||0.0105|TWO_SIDED||||||Fisher Exact|||||||0.0105
71939259|NCT00620763|143399080|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.0|STANDARD_ERROR_OF_MEAN|2.0||0.02||95.0|||||Mixed Models Analysis|Mixed model analysis of variance tested for treatment and feeding sequence effects.||16 subjects required to detect a difference in Calcium 47 absorption of 2 percentage points with 90% power, alpha = 0.05||||0.02
71939260|NCT00368966|143399086|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (\>) -10%.|Difference|-0.6||||||95.0|-2.9|1.6||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated||1.6|-2.9|
71939261|NCT00368966|143399086|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|1.2||||||95.0|-2.3|4.9||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated||4.9|-2.3|
71939262|NCT00368966|143399086|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated||1.3|-1.3|
71939263|NCT00368966|143399087|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated||0.86|0.60|
71939264|NCT00368966|143399088|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.81||||||95.0|0.7|0.94||||||For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.70|
71939265|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
71939266|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|9.28||||||95.0|8.18|10.53||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated||10.53|8.18|
71939267|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.15||||||95.0|1.05|1.25||||||For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.25|1.05|
71939268|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.61||||||95.0|1.41|1.83||||||For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.83|1.41|
71939269|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.45||||||95.0|1.3|1.61||||||For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.61|1.30|
71939270|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|0.93||||||95.0|0.83|1.03||||||For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.03|0.83|
71939271|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|4.0||||||95.0|3.55|4.5||||||For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||4.50|3.55|
71939272|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.6||||||95.0|1.46|1.76||||||For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.76|1.46|
71939273|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.35|1.13|
71939274|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.94||||||95.0|1.78|2.11||||||For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.11|1.78|
71939275|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|2.87||||||95.0|2.58|3.2||||||For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||3.20|2.58|
71939276|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|2.18||||||95.0|1.98|2.41||||||For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||2.41|1.98|
71939277|NCT00368966|143399091|SUPERIORITY_OR_OTHER||Difference|1.3||||||95.0|1.18|1.44||||||For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.||1.44|1.18|
71939278|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
71939279|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.9||||||95.0|-6.0|2.0||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated||2.0|-6.0|
71939280|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.3|-1.3|
71939281|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.3|-1.3|
71939282|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.3||||||95.0|-5.2|2.6||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated||2.6|-5.2|
71939283|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.3|-1.3|
71939284|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.4|3.2||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated||3.2|-4.4|
71939285|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.7|1.7||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.7|-1.7|
71939286|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.4||||||95.0|-5.1|2.2||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated||2.2|-5.1|
71939287|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated||1.4|-1.4|
71939288|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated||1.4|-1.4|
71939289|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.6||||||95.0|-4.6|3.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated||3.3|-4.6|
71939290|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated||1.4|-1.4|
71939291|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-1.7||||||95.0|-5.8|2.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated||2.3|-5.8|
71939292|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.7|||||TWO_SIDED|95.0|-2.5|0.7||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.7|-2.5|
71939293|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
71939294|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|-0.8|||||TWO_SIDED|95.0|-2.8|0.8||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||0.8|-2.8|
71939295|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.5|-1.5|
71939296|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-2.1|2.9||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||2.9|-2.1|
71939297|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.3|1.3||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.3|-1.3|
71939298|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.8|||||TWO_SIDED|95.0|-2.1|3.8||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated||3.8|-2.1|
71939299|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.8|1.7||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated||1.7|-1.8|
71939300|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.4|1.3||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||1.3|-1.4|
71939301|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.7|||||TWO_SIDED|95.0|-0.6|2.6||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.6|-0.6|
71939302|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.0|2.0||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated||2.0|-1.0|
71939303|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
71939304|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.4|||||TWO_SIDED|95.0|-1.1|2.2||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||2.2|-1.1|
71939305|NCT00368966|143399092|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) \> -10%.|Difference|0.0|||||TWO_SIDED|95.0|-1.5|1.5||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated||1.5|-1.5|
71939306|NCT00368966|143399093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.82|1.23||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||1.23|0.82|
71939307|NCT00368966|143399093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.76|1.18||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.18|0.76|
71939308|NCT00368966|143399093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.76|1.19||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.19|0.76|
71939309|NCT00368966|143399093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.69|0.98||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated||0.98|0.69|
71939310|NCT00368966|143399093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.9||||||95.0|0.75|1.09||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated||1.09|0.75|
71939311|NCT00368966|143399093|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.88|1.29||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated||1.29|0.88|
71939312|NCT00368966|143399094|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.75|0.96||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.75|
71939313|NCT00368966|143399094|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.88|1.2||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.88|
71939314|NCT00368966|143399094|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.71|1.02||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.71|
71939315|NCT00368966|143399094|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.12||||||95.0|0.9|1.4||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.40|0.90|
71939316|NCT00368966|143399095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.93|1.13||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.93|
71939317|NCT00368966|143399095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.96|1.2||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.20|0.96|
71939318|NCT00368966|143399095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.05||||||95.0|0.92|1.18||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.18|0.92|
71939319|NCT00368966|143399095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.88|1.14||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.14|0.88|
71693347|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|37.3||||||95.0|0.1|157.7|||ED-50: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.|Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||157.7|0.1|
71693348|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|123.9||||||95.0|0.4|523.9|||ED 90: Bootstrap Method||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.|Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G\*exp(B\*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.||523.9|0.4|
71693349|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|2.472||0.0983||95.0|-8.97|0.77|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.77|-8.97|0.0983
71693350|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.03|STANDARD_ERROR_OF_MEAN|2.415||0.0966||95.0|-8.78|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-8.78|0.0966
71693351|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.29|STANDARD_ERROR_OF_MEAN|2.548||0.0013||95.0|-13.31|-3.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.28|-13.31|0.0013
71693352|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.16|STANDARD_ERROR_OF_MEAN|2.437||0.0353||95.0|-9.96|-0.36|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.36|-9.96|0.0353
71693353|NCT00676403|142901926|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.53|STANDARD_ERROR_OF_MEAN|2.469||0.0006||95.0|-13.4|-3.67|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.67|-13.40|0.0006
71693354|NCT00676403|142901927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8784||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8784
71693355|NCT00676403|142901927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6767||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6767
71693356|NCT00676403|142901927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8955||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8955
71693357|NCT00676403|142901927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9505||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9505
71693358|NCT00676403|142901927|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0466||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0466
71939320|NCT00368966|143399095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.88|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.88|
71939321|NCT00368966|143399095|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.78|1.02||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.02|0.78|
71939322|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|0.1|4.4||||||For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||4.4|0.1|
71693359|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3876||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3876
71693360|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7959||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7959
71693361|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2032
71693362|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7032||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.7032
71693363|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0551||95.0|||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0551
71693364|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.41||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.4100
71939323|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|41.2||||||95.0|34.9|46.9||||||For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||46.9|34.9|
71939324|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|7.3||||||95.0|4.1|10.4||||||For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||10.4|4.1|
71939325|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|-1.1||||||95.0|-3.4|1.2||||||For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||1.2|-3.4|
71693365|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6524||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6524
71693366|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3219||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3219
71693367|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3509||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3509
71693368|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0053||95.0|||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0053
71693369|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9835||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9835
71693370|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6668||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6668
71693371|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2823||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.2823
71693372|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5687
71939326|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|6.4||||||95.0|3.1|9.5||||||For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||9.5|3.1|
71939327|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
71939328|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|26.5||||||95.0|20.7|31.9||||||For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||31.9|20.7|
71939329|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|3.0||||||95.0|0.8|5.1||||||For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||5.1|0.8|
71939330|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|2.2||||||95.0|-1.8|6.3||||||For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||6.3|-1.8|
71939331|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|10.0||||||95.0|5.9|13.9||||||For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||13.9|5.9|
71939332|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|13.0||||||95.0|8.6|17.2||||||For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||17.2|8.6|
71693373|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0043||95.0|||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0043
71693374|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8662||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.8662
71693375|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3656||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3656
71693376|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0806||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0806
71693377|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5381||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.5381
71693378|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009||95.0|||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0090
71693379|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9748||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.9748
71693380|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3936||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.3936
71693381|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1563||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.1563
71693382|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6357||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.6357
71693383|NCT00676403|142901928|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0133||95.0|||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.||||0.0133
71939333|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.1|3.1||||||For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.1|-0.1|
71939334|NCT00368966|143399096|SUPERIORITY_OR_OTHER||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated||3.4|-0.4|
71939335|NCT01694485|143399104|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.35||||0.021|TWO_SIDED|90.0|1.41|7.95|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||7.95|1.41|0.021
71939336|NCT01694485|143399104|SUPERIORITY||Difference in Adjusted Remission Rates|9.0|||||TWO_SIDED|90.0|1.6|14.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.6|1.6|
71693384|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.6|STANDARD_ERROR_OF_MEAN|8.05||0.4133||95.0|-22.4|9.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.4|0.4133
71693385|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|STANDARD_ERROR_OF_MEAN|7.92||0.6676||95.0|-19.0|12.2|||Mixed Models Analysis|||Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.2|-19.0|0.6676
71939337|NCT01694485|143399104|SUPERIORITY|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.33||||0.03|TWO_SIDED|90.0|1.34|8.26|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.26|1.34|0.030
71939338|NCT01694485|143399104|SUPERIORITY||Difference in Adjusted Remission Rates|8.9|||||TWO_SIDED|90.0|0.8|14.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||14.9|0.8|
71939339|NCT01694485|143399104|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.64||||0.64|TWO_SIDED|90.0|0.13|3.17|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.17|0.13|0.64
71939340|NCT01694485|143399104|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.6|||||TWO_SIDED|90.0|-5.2|5.5||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.5|-5.2|
71939341|NCT01694485|143399104|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.34||||0.49|TWO_SIDED|90.0|0.03|4.33|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.33|0.03|0.49
71939342|NCT01694485|143399104|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-2.9|||||TWO_SIDED|90.0|-5.5|5.4||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.4|-5.5|
71939343|NCT01694485|143399105|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.78|||<|0.001|TWO_SIDED|90.0|1.71|4.52|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.52|1.71|<0.001
71939344|NCT01694485|143399105|SUPERIORITY||Difference in Adjusted Response Rates|23.4|||||TWO_SIDED|90.0|11.8|33.2||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||33.2|11.8|
71939345|NCT01694485|143399105|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.57||||0.003|TWO_SIDED|90.0|1.53|4.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.31|1.53|0.003
71939346|NCT01694485|143399105|SUPERIORITY||Difference in Adjusted Response Rates|21.4|||||TWO_SIDED|90.0|9.0|31.8||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||31.8|9.0|
71693386|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|8.04||0.9355||95.0|-16.5|15.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.2|-16.5|0.9355
71761114|NCT01039376|143023892|SUPERIORITY||Mean Difference (Final Values)|0.52||||0.6398|TWO_SIDED|95.0|-1.67|2.72||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Infection Scale|||2.72|-1.67|0.6398
71939347|NCT01694485|143399105|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|2.54||||0.024|TWO_SIDED|90.0|1.29|5.02|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||5.02|1.29|0.024
71939348|NCT01694485|143399105|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|21.2|||||TWO_SIDED|90.0|4.9|34.1||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||34.1|4.9|
71939349|NCT01694485|143399105|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.4||||0.18|TWO_SIDED|90.0|0.13|1.22|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.22|0.13|0.18
71939350|NCT01694485|143399105|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|-13.7|||||TWO_SIDED|90.0|-24.4|2.7||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.7|-24.4|
71939351|NCT01694485|143399106|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.34||||0.011|TWO_SIDED|90.0|1.35|4.07|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors.|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.07|1.35|0.011
71939352|NCT01694485|143399106|SUPERIORITY||Difference in Adjusted Healing Rates|15.3|||||TWO_SIDED|90.0|4.8|24.0||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||24.0|4.8|
71939353|NCT01694485|143399106|SUPERIORITY|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.1||||0.041|TWO_SIDED|90.0|1.15|3.82|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||3.82|1.15|0.041
71939354|NCT01694485|143399106|SUPERIORITY||Difference in Adjusted Healing Rates|13.0|||||TWO_SIDED|90.0|1.7|22.1||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||22.1|1.7|
71939355|NCT01694485|143399106|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.8||||0.68|TWO_SIDED|90.0|0.32|1.97|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||1.97|0.32|0.68
71939356|NCT01694485|143399106|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-3.0|||||TWO_SIDED|90.0|-11.9|9.4||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||9.4|-11.9|
71939357|NCT01694485|143399106|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.69||||0.6|TWO_SIDED|90.0|0.21|2.22|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio \> 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||2.22|0.21|0.60
71939358|NCT01694485|143399106|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-4.6|||||TWO_SIDED|90.0|-14.9|11.3||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||11.3|-14.9|
71939359|NCT01694485|143399107|SUPERIORITY||Odds Ratio (OR)|2.94||||0.09|TWO_SIDED|90.0|1.03|8.36|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||8.36|1.03|0.090
71939360|NCT01694485|143399107|SUPERIORITY||Difference in Adjusted Remission Rates|5.8|||||TWO_SIDED|90.0|-0.6|10.4||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||10.4|-0.6|
71939361|NCT01694485|143399107|SUPERIORITY||Odds Ratio (OR)|1.32||||0.72|TWO_SIDED|90.0|0.38|4.56|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.56|0.38|0.72
71939362|NCT01694485|143399107|SUPERIORITY||Difference in Adjusted Remission Rates|1.0|||||TWO_SIDED|90.0|-4.7|4.6||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.6|-4.7|
71939363|NCT01694485|143399107|SUPERIORITY|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.83||||0.86|TWO_SIDED|90.0|0.16|4.41|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||4.41|0.16|0.86
71939364|NCT01694485|143399107|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-0.5|||||TWO_SIDED|90.0|-3.9|6.2||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.2|-3.9|
71939365|NCT01694485|143399107|SUPERIORITY|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.49||||0.64|TWO_SIDED|90.0|0.04|6.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio \> 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.31|0.04|0.64
71939366|NCT01694485|143399107|SUPERIORITY|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.7|||||TWO_SIDED|90.0|-4.2|6.4||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).||6.4|-4.2|
71939367|NCT00662025|143399137|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|30.2|||||TWO_SIDED|95.0|19.2|43.0||||||||43.0|19.2|
71939368|NCT00662025|143399138|SUPERIORITY_OR_OTHER||Objective Response Rate (percentage)|27.0|||||TWO_SIDED|95.0|16.6|39.7||||||||39.7|16.6|
71939369|NCT00662025|143399139|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|50.8|||||TWO_SIDED|95.0|37.9|63.6||||||||63.6|37.9|
71939370|NCT00662025|143399140|SUPERIORITY_OR_OTHER||CBR Rate (percentage)|52.4|||||TWO_SIDED|95.0|39.4|65.1||||||||65.1|39.4|
71939371|NCT03179345|143399154|SUPERIORITY||Mean Difference (Net)|-0.141|STANDARD_ERROR_OF_MEAN|0.06||0.0275|TWO_SIDED|95.0|-0.266|-0.016|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.016|-0.266|0.0275
71939372|NCT03179345|143399154|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
71939373|NCT03179345|143399155|SUPERIORITY||Mean Difference (Net)|-0.102|STANDARD_ERROR_OF_MEAN|0.06||0.1103|TWO_SIDED|95.0|-0.227|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.024|-0.227|0.1103
71939374|NCT03179345|143399155|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.06||0.0611|TWO_SIDED|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.245|-0.006|0.0611
71939375|NCT03179345|143399156|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9946|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9946
71939376|NCT03179345|143399156|SUPERIORITY||Mean Difference (Net)|0.02|STANDARD_ERROR_OF_MEAN|0.0125||0.1673|TWO_SIDED|95.0|-0.01|0.04|||ANCOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.04|-0.01|0.1673
71939377|NCT03179345|143399156|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0125||0.6208|TWO_SIDED|95.0|-0.02|0.03|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.03|-0.02|0.6208
71939378|NCT03179345|143399157|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|2.6||0.8799|TWO_SIDED|95.0|-5.59|4.8|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||4.80|-5.59|0.8799
71939379|NCT03179345|143399157|SUPERIORITY||Mean Difference (Net)|0.24|STANDARD_ERROR_OF_MEAN|2.61||0.9277|TWO_SIDED|95.0|-4.97|5.45|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||5.45|-4.97|0.9277
71939380|NCT03179345|143399157|SUPERIORITY||Mean Difference (Net)|-3.73||||0.1587|TWO_SIDED|95.0|-8.94|1.49|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.49|-8.94|0.1587
71939381|NCT03179345|143399158|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.0125||0.7111|TWO_SIDED|95.0|-0.03|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.03|0.7111
71939382|NCT03179345|143399158|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.01||0.9048|TWO_SIDED|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.02|0.9048
71939383|NCT03179345|143399158|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.01||0.3262|TWO_SIDED|95.0|-0.03|0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.01|-0.03|0.3262
71939384|NCT03179345|143399159|SUPERIORITY||Mean Difference (Net)|-0.46|STANDARD_ERROR_OF_MEAN|0.86||0.595|TWO_SIDED|95.0|-2.18|1.26|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.26|-2.18|0.5950
71939385|NCT03179345|143399159|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.865||0.7057|TWO_SIDED|95.0|-1.4|2.06|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.06|-1.40|0.7057
71939386|NCT03179345|143399159|SUPERIORITY||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|0.865||0.6741|TWO_SIDED|95.0|-1.36|2.1|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||2.10|-1.36|0.6741
71939387|NCT03179345|143399160|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.0175||0.007|TWO_SIDED|95.0|-0.08|-0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||-0.01|-0.08|0.0070
71939388|NCT03179345|143399160|SUPERIORITY||Mean Difference (Net)|0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5183|TWO_SIDED|95.0|-0.02|0.05|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.05|-0.02|0.5183
71939389|NCT03179345|143399160|SUPERIORITY||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.0175||0.5084|TWO_SIDED|95.0|-0.05|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.02|-0.05|0.5084
71939390|NCT03179345|143399161|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.307||0.1026|TWO_SIDED|95.0|-0.104|1.124|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.124|-0.104|0.1026
71939391|NCT03179345|143399161|SUPERIORITY||Mean Difference (Net)|-0.094|STANDARD_ERROR_OF_MEAN|0.309||0.7634|TWO_SIDED|95.0|-0.711|0.523|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.523|-0.711|0.7634
71939392|NCT03179345|143399161|SUPERIORITY||Mean Difference (Net)|0.51|STANDARD_ERROR_OF_MEAN|0.309||0.1041|TWO_SIDED|95.0|-0.107|1.127|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.127|-0.107|0.1041
71939393|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.286|STANDARD_ERROR_OF_MEAN|0.12||0.0177|TWO_SIDED|95.0|-0.521|-0.051|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||-0.051|-0.521|0.0177
71939394|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.157|STANDARD_ERROR_OF_MEAN|0.19||0.412|TWO_SIDED|95.0|-0.536|0.222|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.222|-0.536|0.4120
71939395|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.046|STANDARD_ERROR_OF_MEAN|0.16||0.7724|TWO_SIDED|95.0|-0.362|0.27|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.270|-0.362|0.7724
71939396|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.121|STANDARD_ERROR_OF_MEAN|0.15||0.4255|TWO_SIDED|95.0|-0.423|0.18|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.180|-0.423|0.4255
71939397|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.017|STANDARD_ERROR_OF_MEAN|0.12||0.8925|TWO_SIDED|95.0|-0.229|0.262|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in activities||0.262|-0.229|0.8925
71939398|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.212|STANDARD_ERROR_OF_MEAN|0.14||0.1293|TWO_SIDED|95.0|-0.487|0.063|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.063|-0.487|0.1293
71939399|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|0.06||0.0304|TWO_SIDED|95.0|-0.266|-0.014|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.014|-0.266|0.0304
71939400|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.084|STANDARD_ERROR_OF_MEAN|0.15||0.5811|TWO_SIDED|95.0|-0.384|0.217|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.217|-0.384|0.5811
71939401|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.098|STANDARD_ERROR_OF_MEAN|0.06||0.1144|TWO_SIDED|95.0|-0.22|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.024|-0.220|0.1144
71939402|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.109|STANDARD_ERROR_OF_MEAN|0.12||0.3774|TWO_SIDED|95.0|-0.352|0.135|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.135|-0.352|0.3774
71939403|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.057|STANDARD_ERROR_OF_MEAN|0.34||0.8658|TWO_SIDED|95.0|-0.613|0.727|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.727|-0.613|0.8658
71939404|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.018|STANDARD_ERROR_OF_MEAN|0.1||0.8543|TWO_SIDED|95.0|-0.179|0.216|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.216|-0.179|0.8543
71939405|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.153|STANDARD_ERROR_OF_MEAN|0.19||0.4294|TWO_SIDED|95.0|-0.537|0.231|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.231|-0.537|0.4294
71939406|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.113|STANDARD_ERROR_OF_MEAN|0.12||0.3613|TWO_SIDED|95.0|-0.357|0.132|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.132|-0.357|0.3613
71939407|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.047|STANDARD_ERROR_OF_MEAN|0.13||0.7201|TWO_SIDED|95.0|-0.305|0.212|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.212|-0.305|0.7201
71939408|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.213|STANDARD_ERROR_OF_MEAN|0.12||0.0767|TWO_SIDED|95.0|-0.448|0.023|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.023|-0.448|0.0767
71939409|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.216|STANDARD_ERROR_OF_MEAN|0.19||0.2618|TWO_SIDED|95.0|-0.597|0.165|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.165|-0.597|0.2618
71939410|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.048|STANDARD_ERROR_OF_MEAN|0.16||0.7633|TWO_SIDED|95.0|-0.366|0.269|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.269|-0.366|0.7633
71939411|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.198|STANDARD_ERROR_OF_MEAN|0.15||0.1968|TWO_SIDED|95.0|-0.502|0.105|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.105|-0.502|0.1968
71939412|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.05|STANDARD_ERROR_OF_MEAN|0.12||0.6891|TWO_SIDED|95.0|-0.296|0.197|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.197|-0.296|0.6891
71939413|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.14||0.2229|TWO_SIDED|95.0|-0.447|0.106|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.106|-0.447|0.2229
71939414|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.072|STANDARD_ERROR_OF_MEAN|0.06||0.2591|TWO_SIDED|95.0|-0.197|0.054|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||0.054|-0.197|0.2591
71939415|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.15||0.7099|TWO_SIDED|95.0|-0.359|0.246|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.246|-0.359|0.7099
71939416|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.031|STANDARD_ERROR_OF_MEAN|0.06||0.6215|TWO_SIDED|95.0|-0.154|0.092|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.092|-0.154|0.6215
71939417|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.057|STANDARD_ERROR_OF_MEAN|0.12||0.6422|TWO_SIDED|95.0|-0.302|0.187|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.187|-0.302|0.6422
71939418|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.483|STANDARD_ERROR_OF_MEAN|0.34||0.1574|TWO_SIDED|95.0|-1.157|0.19|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.190|-1.157|0.1574
71939419|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.084|STANDARD_ERROR_OF_MEAN|0.1||0.4039|TWO_SIDED|95.0|-0.115|0.282|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.282|-0.115|0.4039
71939420|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.309|STANDARD_ERROR_OF_MEAN|0.19||0.1145|TWO_SIDED|95.0|-0.695|0.076|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.076|-0.695|0.1145
71939421|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.127|STANDARD_ERROR_OF_MEAN|0.12||0.3083|TWO_SIDED|95.0|-0.372|0.119|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.119|-0.372|0.3083
71939422|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.183|STANDARD_ERROR_OF_MEAN|0.13||0.1638|TWO_SIDED|95.0|-0.443|0.0776|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation||0.0776|-0.443|0.1638
71939423|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.078|STANDARD_ERROR_OF_MEAN|0.12||0.5101|TWO_SIDED|95.0|-0.314|0.157|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision||0.157|-0.314|0.5101
71939424|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.233|STANDARD_ERROR_OF_MEAN|0.19||0.2285|TWO_SIDED|95.0|-0.614|0.149|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level||0.149|-0.614|0.2285
71939425|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.118|STANDARD_ERROR_OF_MEAN|0.16||0.4612|TWO_SIDED|95.0|-0.2|0.436|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory||0.436|-0.200|0.4612
71939426|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.099|STANDARD_ERROR_OF_MEAN|0.15||0.519|TWO_SIDED|95.0|-0.205|0.402|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance||0.402|-0.205|0.5190
71939427|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.024|STANDARD_ERROR_OF_MEAN|0.12||0.8479|TWO_SIDED|95.0|-0.271|0.223|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities||0.223|-0.271|0.8479
71939428|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.039|STANDARD_ERROR_OF_MEAN|0.14||0.7808|TWO_SIDED|95.0|-0.316|0.238|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination||0.238|-0.316|0.7808
71939429|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.171|STANDARD_ERROR_OF_MEAN|0.06||0.0083|TWO_SIDED|95.0|-0.296|-0.045|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor||-0.045|-0.296|0.0083
71939430|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.101|STANDARD_ERROR_OF_MEAN|0.15||0.5068|TWO_SIDED|95.0|-0.404|0.201|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration||0.201|-0.404|0.5068
71939431|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.068|STANDARD_ERROR_OF_MEAN|0.06||0.2725|TWO_SIDED|95.0|-0.191|0.055|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech||0.055|-0.191|0.2725
71939432|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.039|STANDARD_ERROR_OF_MEAN|0.12||0.7498|TWO_SIDED|95.0|-0.206|0.284|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness||0.284|-0.206|0.7498
71939433|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.152|STANDARD_ERROR_OF_MEAN|0.34||0.6554|TWO_SIDED|95.0|-0.522|0.826|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness||0.826|-0.522|0.6554
71939434|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.1||0.4143|TWO_SIDED|95.0|-0.116|0.28|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness||0.280|-0.116|0.4143
71939435|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.055|STANDARD_ERROR_OF_MEAN|0.19||0.7761|TWO_SIDED|95.0|-0.441|0.33|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness||0.330|-0.441|0.7761
71939436|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|0.005|STANDARD_ERROR_OF_MEAN|0.12||0.9697|TWO_SIDED|95.0|-0.241|0.251|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span||0.251|-0.241|0.9697
71939437|NCT03179345|143399162|SUPERIORITY||Mean Difference (Net)|-0.086|STANDARD_ERROR_OF_MEAN|0.13||0.5118|TWO_SIDED|95.0|-0.346|0.174|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.||Motivation|SE of difference estimated by dividing width of 95% CI by 4.|0.174|-0.346|0.5118
71939438|NCT03179345|143399163|SUPERIORITY||Mean Difference (Net)|-0.116|STANDARD_ERROR_OF_MEAN|0.53||0.8293|TWO_SIDED|95.0|-1.178|0.947|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.947|-1.178|0.8293
71693387|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|7.97||0.9355||95.0|-15.1|16.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-15.1|0.9355
71939439|NCT03179345|143399163|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
71939440|NCT03179345|143399164|SUPERIORITY||Mean Difference (Net)|-0.488|STANDARD_ERROR_OF_MEAN|0.53||0.3666|TWO_SIDED|95.0|-1.556|0.581|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||0.581|-1.556|0.3666
71939441|NCT03179345|143399164|SUPERIORITY||Mean Difference (Net)|-0.02|STANDARD_ERROR_OF_MEAN|0.53||0.9705|TWO_SIDED|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|||1.049|-1.089|0.9705
71693388|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|7.94||0.1895||95.0|-26.1|5.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-26.1|0.1895
71693389|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.9|STANDARD_ERROR_OF_MEAN|8.1||0.1443||95.0|-27.8|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-27.8|0.1443
71693390|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4|STANDARD_ERROR_OF_MEAN|7.96||0.2946||95.0|-24.0|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-24.0|0.2946
71693391|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.4|STANDARD_ERROR_OF_MEAN|8.22||0.3686||95.0|-23.6|8.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.8|-23.6|0.3686
71939442|NCT02300025|143399166|SUPERIORITY_OR_OTHER||LS means ratio|92.2|||||TWO_SIDED|90.0|59.2|143.4|||||The 90% CI for differences in LS means between test and reference treatments obtained from mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model analysis of variance (ANOVA) to determine 90% confidence interval (CI) of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The least squares (LS) means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||143.4|59.2|
71939443|NCT02300025|143399166|SUPERIORITY_OR_OTHER||LS means ratio|84.9|||||TWO_SIDED|90.0|54.6|132.1|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||132.1|54.6|
71939444|NCT02300025|143399166|SUPERIORITY_OR_OTHER||LS means ratio|39.0|||||TWO_SIDED|90.0|25.1|60.7|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||60.7|25.1|
71939445|NCT02300025|143399168|SUPERIORITY_OR_OTHER||LS means ratio|98.4|||||TWO_SIDED|90.0|52.0|186.0|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||186.0|52.0|
71939446|NCT02300025|143399168|SUPERIORITY_OR_OTHER||LS means ratio|102.2|||||TWO_SIDED|90.0|54.0|193.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||193.2|54.0|
71693392|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|8.02||0.6079||95.0|-19.9|11.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-19.9|0.6079
71693393|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-25.5|STANDARD_ERROR_OF_MEAN|7.99||0.0016||95.0|-41.2|-9.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-9.7|-41.2|0.0016
71693394|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.5976||95.0|-20.5|11.8|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-20.5|0.5976
71693395|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.5|STANDARD_ERROR_OF_MEAN|8.0||0.8527||95.0|-14.3|17.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-14.3|0.8527
71761115|NCT01039376|143023892|SUPERIORITY||Mean Difference (Final Values)|-4.32||||0.0055|TWO_SIDED|95.0|-7.37|-1.28||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Problems Scale|||-1.28|-7.37|0.0055
71939447|NCT02300025|143399168|SUPERIORITY_OR_OTHER||LS means ratio|42.5|||||TWO_SIDED|90.0|22.5|80.5|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||80.5|22.5|
71939448|NCT02300025|143399169|SUPERIORITY_OR_OTHER||LS means ratio|97.6|||||TWO_SIDED|90.0|59.3|160.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||160.6|59.3|
71939449|NCT02300025|143399169|SUPERIORITY_OR_OTHER||LS means ratio|103.0|||||TWO_SIDED|90.0|62.6|169.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||169.6|62.6|
71939450|NCT02300025|143399169|SUPERIORITY_OR_OTHER||LS means ratio|68.5|||||TWO_SIDED|90.0|40.4|116.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).||116.2|40.4|
71939451|NCT00626925|143399175|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71939452|NCT00626925|143399176|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71939453|NCT00626925|143399178|SUPERIORITY_OR_OTHER|||||||0.004|||||||Mixed Models Analysis|||||||0.004
71939454|NCT00626925|143399179|SUPERIORITY_OR_OTHER|||||||0.04|||||||Mixed Models Analysis|||||||0.04
71939455|NCT00626925|143399180|SUPERIORITY_OR_OTHER|||||||0.001|||||||Mixed Models Analysis|||||||0.001
71939456|NCT00626925|143399181|SUPERIORITY_OR_OTHER|||||||0.06|||||||Mixed Models Analysis|||||||0.06
71939457|NCT00626925|143399182|SUPERIORITY_OR_OTHER|||||||0.01|||||||Mixed Models Analysis|||||||0.01
71939458|NCT00780026|143399183|SUPERIORITY_OR_OTHER|||||||0.841||||||P value for Bacterial infection|Chi-squared|||||||0.841
71939459|NCT00780026|143399183|SUPERIORITY_OR_OTHER|||||||0.298||||||P-value for fungal infection|Chi-squared|||||||0.298
71939460|NCT00780026|143399183|SUPERIORITY_OR_OTHER|||||||0.585||||||P value for transplant incision wound|Chi-squared|||||||0.585
71939461|NCT00780026|143399183|SUPERIORITY_OR_OTHER|||||||0.505||||||P value for viral infection|Chi-squared|||||||0.505
71939462|NCT00780026|143399184|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
71939463|NCT00780026|143399185|EQUIVALENCE|If the p-value for the means is \> 0.05 between the groups then they will be deemed equivalent.||||||0.384|||||||Wilcoxon (Mann-Whitney)|||||||0.384
71939464|NCT00780026|143399187|SUPERIORITY_OR_OTHER|||||||0.401|||||||Fisher Exact|||||||0.401
71939465|NCT00780026|143399188|SUPERIORITY_OR_OTHER|||||||0.826||||||P value for bile leak|Chi-squared|||||||0.826
71939466|NCT00780026|143399188|SUPERIORITY_OR_OTHER|||||||0.137||||||This is the p value for Biliary Stricture|Chi-squared|||||||0.137
71939467|NCT00780026|143399189|SUPERIORITY_OR_OTHER|||||||0.999|||||||Fisher Exact|||||||0.999
71939468|NCT01966042|143399219|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Friedman test (n=13)|||||||< 0.001
71939469|NCT03522948|143399224|SUPERIORITY||Mean Difference (Net)|-3.16|STANDARD_DEVIATION|-0.71||0.03|TWO_SIDED||||||t-test, 2 sided|||within-subject t-test||||.03
71939470|NCT03522948|143399225|SUPERIORITY||t-test|-1.34|STANDARD_DEVIATION|3.2||0.23|TWO_SIDED||||||t-test, 2 sided||||d = -0.51|||0.23
71939471|NCT03522948|143399226|SUPERIORITY||t-test|1.35|||<|0.05|TWO_SIDED|95.0|-0.69|2.41|||t-test, 2 sided|||GSAB self-efficacy||2.41|-0.69|<.05
71939472|NCT03522948|143399227|SUPERIORITY||t-test|2.93|||<|0.05|TWO_SIDED|95.0|0.31|3.41|||t-test, 2 sided|||Test of GSAB self-efficacy subscale for condom use||3.41|0.31|<.05
71939473|NCT01047345|143399243|SUPERIORITY_OR_OTHER||Difference in Percentages|3.5||||0.026|TWO_SIDED|95.0|0.5|6.2|||Miettinen & Nurminen|||||6.2|0.5|0.026
71939474|NCT01047345|143399244|SUPERIORITY_OR_OTHER||Difference in Percentages|4.0|||||TWO_SIDED|95.0|-2.8|10.8|||Miettinen & Nurminen|||||10.8|-2.8|
71939475|NCT01047345|143399245|SUPERIORITY_OR_OTHER||Difference in Percentages|0.0|||||TWO_SIDED|95.0|-1.5|0.9|||Miettinen & Nurminen|||||0.9|-1.5|
71939476|NCT01047345|143399246|SUPERIORITY_OR_OTHER||Difference in Percentages|-0.2|||||TWO_SIDED|95.0|-1.7|0.6|||Miettinen & Nurminen|||||0.6|-1.7|
71939477|NCT01047345|143399247|SUPERIORITY_OR_OTHER||Difference in Percentages|10.2|||||TWO_SIDED|95.0|7.5|13.1|||Miettinen & Nurminen|||||13.1|7.5|
71939478|NCT01047345|143399248|SUPERIORITY_OR_OTHER||Seroconversion rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 31||100.0|98.9|<0.001
71939479|NCT01047345|143399248|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 33||100.0|98.9|<0.001
71939480|NCT01047345|143399248|SUPERIORITY_OR_OTHER||Seroconversion Rate|98.3|||<|0.001|TWO_SIDED|95.0|96.7|99.2||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 45||99.2|96.7|<0.001
71939481|NCT01047345|143399248|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.6|||<|0.001|TWO_SIDED|95.0|98.6|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 52||100.0|98.6|<0.001
71939482|NCT01047345|143399248|SUPERIORITY_OR_OTHER||Seroconversion Rate|99.8|||<|0.001|TWO_SIDED|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 58||100.0|98.9|<0.001
71761116|NCT01039376|143023892|SUPERIORITY||Mean Difference (Final Values)|-2.49||||0.0063|TWO_SIDED|95.0|-4.27|-0.71||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Side Effects Scale|||-0.71|-4.27|0.0063
71939483|NCT00282256|143399250|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for AUC0-24 was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|100.9|||||TWO_SIDED|90.0|90.8|112.1|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.||112.1|90.8|
71939484|NCT00282256|143399252|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for Cmin was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|91.8|||||TWO_SIDED|90.0|82.6|102.2|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.||102.2|82.6|
71939485|NCT00698685|143399268|SUPERIORITY_OR_OTHER||actuarial probability of engraftment|70.0||||||95.0|||||||Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.|||||
71939486|NCT00455533|143399274|SUPERIORITY_OR_OTHER|||||||0.8921||95.0|||||Fisher Exact|||||||0.8921
71939487|NCT00455533|143399274|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.96||||0.8966|TWO_SIDED|90.0|0.6|1.55|||Cochran-Mantel-Haenszel|||||1.55|0.60|0.8966
71939488|NCT00455533|143399274|SUPERIORITY_OR_OTHER||difference in pCR|-0.6|||||TWO_SIDED|95.0|-7.9|6.7|||||The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.7|-7.9|
71939489|NCT00455533|143399277|SUPERIORITY_OR_OTHER|||||||0.6186||95.0|||||Fisher Exact|||||||0.6186
71939490|NCT00455533|143399277|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.86||||0.5806|TWO_SIDED|90.0|0.56|1.34|||Cochran-Mantel-Haenszel|||||1.34|0.56|0.5806
71939491|NCT00455533|143399277|SUPERIORITY_OR_OTHER||difference|-2.5|||||TWO_SIDED|90.0|-11.0|6.0|||||The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.|||6.0|-11|
71939492|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4115||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 (209993\_at)||||0.4115
71939493|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.1629
71939494|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5074
71939495|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.553||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.5530
71939496|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1845||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1845
71939497|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3538||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.3538
71939498|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.9751||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9751
71939499|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.8874||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.8874
71939500|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.6907||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.6907
71939501|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.8052||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.8052
71939502|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5031||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.5031
71939503|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.7588||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.7588
71939504|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1542||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.1542
71693396|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.29||0.6973||95.0|-19.6|13.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.1|-19.6|0.6973
71693397|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|8.09||0.6895||95.0|-19.2|12.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.7|-19.2|0.6895
71693398|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.1|STANDARD_ERROR_OF_MEAN|8.21||0.0209||95.0|-35.2|-2.9|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.9|-35.2|0.0209
71693399|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|8.18||0.4084||95.0|-22.9|9.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.3|-22.9|0.4084
71693400|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|7.96||0.3958||95.0|-22.5|8.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.9|-22.5|0.3958
71693401|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.25||0.5776||95.0|-20.9|11.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.7|-20.9|0.5776
71693402|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.6|STANDARD_ERROR_OF_MEAN|8.06||0.5665||95.0|-20.5|11.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.3|-20.5|0.5665
71693403|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-23.5|STANDARD_ERROR_OF_MEAN|8.13||0.0041||95.0|-39.6|-7.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.5|-39.6|0.0041
71939505|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0235||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0235
71939506|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3612||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.3612
71939507|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.184||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1840
71939508|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0942||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0942
71939509|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5327||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.5327
71939510|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.8847||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8847
71939511|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.8947||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8947
71693404|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|8.22||0.1842||95.0|-27.1|5.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-27.1|0.1842
71693405|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|8.0||0.8269||95.0|-17.5|14.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.0|-17.5|0.8269
71693406|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.1|STANDARD_ERROR_OF_MEAN|8.34||0.3319||95.0|-24.5|8.3|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.3|-24.5|0.3319
71693407|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|8.09||0.7552||95.0|-13.4|18.5|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-13.4|0.7552
71939512|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4085||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.4085
71939513|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1119||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.1119
71939514|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0250
71939515|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3569||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.3569
71939516|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4103||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.4103
71939517|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.149||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1490
71939518|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.559||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.5590
71939519|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4796||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.4796
71939520|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2794||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2794
71939521|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1646||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1646
71939522|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0782||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0782
71939523|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1407||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.1407
71939524|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2369||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2369
71939525|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.7756||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.7756
71939526|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2623||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2623
71939527|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3147||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.3147
71939528|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2885||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.2885
71939529|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.7187||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.7187
71939530|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.6017||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.6017
71939531|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.4500
71939532|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0952||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0952
71939533|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.7069||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.7069
71693408|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|8.16||0.0137||95.0|-36.3|-4.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-4.2|-36.3|0.0137
71939534|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4767||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.4767
71939535|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.6191||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6191
71939536|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.5276
71939537|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3323||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.3323
71939538|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1025||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1025
71939539|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1715||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1715
71939540|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.1070
71939541|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2751||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2751
71693409|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.0|STANDARD_ERROR_OF_MEAN|8.22||0.1157||95.0|-29.2|3.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.2|-29.2|0.1157
71939542|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0276||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0276
71939543|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1689||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1689
71939544|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0769||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0769
71939545|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1058
71939546|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.6406||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.6406
71939547|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1733||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.1733
71939548|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2631||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2631
71693410|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.04||0.3791||95.0|-22.9|8.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.7|-22.9|0.3791
71693411|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|8.39||0.1329||95.0|-29.2|3.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.9|-29.2|0.1329
71939549|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.217||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.2170
71939550|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0868||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0868
71939551|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1117||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1117
71939552|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4943||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 (208601\_s\_at)||||0.4943
71939553|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.519||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.5190
71939554|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.735||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7350
71939555|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.382||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.3820
71939556|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.929||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.9290
71939557|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0699||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.0699
71939558|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3515||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.3515
71939559|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2128||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2128
71939560|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1275||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.1275
71939561|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2158||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2158
71939562|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.0266||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0266
71939563|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3636||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.3636
71939564|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.9479||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.9479
71939565|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3753||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.3753
71939566|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5477||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5477
71939567|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.476||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.4760
71939568|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3314||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3314
71939569|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.1005||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1005
71939570|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.118||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1180
71939571|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1580
71939572|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4385||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.4385
71939573|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.7324||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.7324
71939574|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2657||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.2657
71939575|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5637||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.5637
71939576|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.4473||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.4473
71939577|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3292||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3292
71939578|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.2054||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.2054
71939579|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.5226||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment: ER) and the reduced model: (PCR \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.5226
71939580|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.172||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR \~ Biomarker: Treatment) and the reduced model: (PCR \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.1720
71939581|NCT00455533|143399278|SUPERIORITY_OR_OTHER|||||||0.3346||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.3346
71939582|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.5604||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5604
71939583|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2715||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.2715
71939584|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.5268||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993\_at||||0.5268
71939585|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6058
71939586|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1918||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.1918
71939587|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6712||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994\_s\_at||||0.6712
71939588|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.9195||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.9195
71939589|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.7021||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.7021
71939590|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.391||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851\_x\_at||||0.3910
71939591|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2909||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2909
71939592|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.3336||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.3336
71939593|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.236||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531\_s\_at||||0.2360
71939594|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0281||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0281
71939595|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0434||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0434
71939596|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0283||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719\_at||||0.0283
71939597|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0151||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0151
71939598|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1999||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.1999
71939599|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0146||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720\_s\_at||||0.0146
71939600|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1185||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.1185
71939601|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.8705||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.8705
71939602|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0284||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315\_s\_at||||0.0284
71939603|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0399||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0399
71939604|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0136||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0136
71693412|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|8.09||0.7723||95.0|-13.6|18.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.3|-13.6|0.7723
71939605|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0576||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317\_at||||0.0576
71939606|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2245||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.2245
71939607|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1388||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.1388
71939608|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0692||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942\_s\_at||||0.0692
71939609|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1058||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.1058
71939610|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.2688
71939611|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0192||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318\_s\_at||||0.0192
71939612|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0033||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0033
71939613|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2053||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.2053
71939614|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0032||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040\_x\_at||||0.0032
71939615|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6783||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.6783
71939616|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.163||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.1630
71939617|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2944||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792\_s\_at||||0.2944
71693413|NCT00676403|142901929|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.5|STANDARD_ERROR_OF_MEAN|8.16||0.0063||95.0|-38.6|-6.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.4|-38.6|0.0063
71939618|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.3727||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.3727
71939619|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.8796||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8796
71939620|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.8344||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808\_at||||0.8344
71939621|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.27||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2700
71939622|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2624||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.2624
71939623|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242\_s\_at||||0.0830
71761117|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-1.48||||0.1816|TWO_SIDED|95.0|-3.64|0.69||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Appetite Loss|||0.69|-3.64|0.1816
71939624|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0849
71939625|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6578||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.6578
71939626|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0396||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733\_at||||0.0396
71939627|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1657||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1657
71939628|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0675||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.0675
71939629|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1071||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476\_s\_at||||0.1071
71939630|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0142||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0142
71939631|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2465||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.2465
71939632|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0031||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477\_s\_at||||0.0031
71939633|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1231||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.1231
71939634|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0849||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.0849
71939635|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.274||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714\_x\_at||||0.2740
71939636|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2383||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2383
71939637|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0644||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.0644
71939638|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2866||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320\_at||||0.2866
71939639|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1259||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.1259
71939640|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0718||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.0718
71939641|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.317||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026\_x\_at||||0.3170
71939642|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.7844||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.7844
71939643|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.4688||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.4688
71939644|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.8553||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601\_s\_at||||0.8553
71939645|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6926||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.6926
71939646|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2222||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.2222
71939647|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.4676||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141\_at||||0.4676
71939648|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2036||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.2036
71939649|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.4197||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.4197
71939650|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0776||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372\_x\_at||||0.0776
71939651|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.4076||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.4076
71939652|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0629||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.0629
71939653|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2547||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023\_x\_at||||0.2547
71939654|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.7125||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.7125
71939655|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6001||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.6001
71939656|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.5398||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977\_x\_at||||0.5398
71939657|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.3970
71939658|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.5085||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.5085
71939659|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1213||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726\_x\_at||||0.1213
71939660|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0999||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.0999
71939661|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1201||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1201
71939662|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.1172||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664\_at||||0.1172
71939663|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.6596||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.6596
71939664|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.3289||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3289
71939665|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.3657||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191\_at||||0.3657
71939666|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0275||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0275
71939667|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.3946||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.3946
71939668|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0074||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589\_at||||0.0074
71939669|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2341||95.0||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 \~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2341
71939670|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.0933||95.0||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 \~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 \~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.0933
71939671|NCT00455533|143399279|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 \~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684\_at||||0.2016
71939672|NCT00455533|143399280|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.145|||||TWO_SIDED|90.0|-0.27|-0.017|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.017|-0.27|
71939673|NCT00455533|143399280|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.064|||||TWO_SIDED|90.0|-0.064|0.197|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker STatus||0.197|-0.064|
71939674|NCT00455533|143399280|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.056|||||TWO_SIDED|90.0|-0.152|0.046|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.046|-0.152|
71693414|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.254||0.1715||95.0|-0.15|0.85|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.85|-0.15|0.1715
71939675|NCT00455533|143399280|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.116|||||TWO_SIDED|90.0|-0.13|0.37|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.37|-0.13|
71939676|NCT00455533|143399281|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.114|||||TWO_SIDED|90.0|-0.258|0.22|||||ixabepilone - paclitaxel|Mem+Cyto/Negative Biomarker Status||0.22|-0.258|
71939677|NCT00455533|143399281|SUPERIORITY_OR_OTHER||DIfference (bootstrap method)|0.009|||||TWO_SIDED|90.0|-0.137|0.155|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.155|-0.137|
71939678|NCT00455533|143399281|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.058|||||TWO_SIDED|90.0|-0.167|0.053|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.053|-0.167|
71939679|NCT00455533|143399281|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|0.049|||||TWO_SIDED|90.0|-0.227|0.309|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status||0.309|-0.227|
71939680|NCT00455533|143399282|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.29|||||TWO_SIDED|90.0|-0.482|-0.094|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status||-0.094|-0.482|
71939681|NCT00455533|143399282|SUPERIORITY_OR_OTHER||Difference (boostrap method)|0.106|||||TWO_SIDED|90.0|-0.073|0.291|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.291|-0.073|
71939682|NCT00455533|143399282|SUPERIORITY_OR_OTHER||Difference (bootstrap method)|-0.09|||||TWO_SIDED|90.0|-0.236|0.067|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status||0.067|-0.236|
71939683|NCT00455533|143399282|SUPERIORITY_OR_OTHER||Difference (bootsrap method)|0.117|||||TWO_SIDED|90.0|-0.218|0.469|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status||0.469|-0.218|
71939684|NCT00539539|143399337|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.001||||0.96|TWO_SIDED|95.0|-0.04|0.05|||t-test, 2 sided|||Average change in cluster-specific rates of ROSC.||0.05|-0.04|0.96
71693415|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.251||0.7944||95.0|-0.43|0.56|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.43|0.7944
71693416|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.255||0.1994||95.0|-0.17|0.83|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.83|-0.17|0.1994
71693417|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.251||0.3652||95.0|-0.27|0.72|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.72|-0.27|0.3652
71693418|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.251||0.0481||95.0|0.0|0.99|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.99|0.00|0.0481
71693419|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.256||0.2501||95.0|-0.21|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.80|-0.21|0.2501
71693420|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.252||0.5191||95.0|-0.33|0.66|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.66|-0.33|0.5191
71939685|NCT00539539|143399338|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.71|TWO_SIDED|95.0|-4.9|3.4|||t-test, 2 sided|||Average difference in cluster-specific rates.||3.4|-4.9|0.71
71939686|NCT00539539|143399339|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.015||||0.21|TWO_SIDED|95.0|-0.039|0.009|||t-test, 2 sided|By-cluster difference in outcome rates.||Average change in cluster-specific risk difference.||0.009|-0.039|0.21
71939687|NCT00539539|143399340|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.9||||0.016|TWO_SIDED|95.0|0.4|3.4|||Regression, Linear|Difference in means, adjusted for cluster.||Cluster adjusted difference in average CPR fraction.||3.4|0.4|0.016
71939688|NCT00539539|143399341|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.6||||0.005|TWO_SIDED|95.0|0.5|2.7|||Regression, Linear|Adjusted for randomization by cluster.||Cluster adjusted difference in means.||2.7|0.5|0.005
71939689|NCT00539539|143399342|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7|||<|0.001|TWO_SIDED|95.0|-6.4|-3.0|||Regression, Linear|||Cluster adjusted difference in average compression rate.||-3.0|-6.4|<0.001
71939690|NCT00539539|143399343|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.4|||<|0.001|TWO_SIDED|95.0|-5.2|-1.5|||Regression, Linear|||Cluster adjusted difference in the average rate.||-1.5|-5.2|<0.001
71939691|NCT00539539|143399344|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.73|TWO_SIDED|95.0|-0.5|0.7|||Regression, Linear|||Cluster adjusted difference in average rate.||0.7|-0.5|0.73
71939692|NCT02260492|143399361|EQUIVALENCE|"Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.~Superiority test compares Test with Placebo (p\<0.05) Superiority test compares Reference with Placebo (p\<0.05) (p\<0.05)"|Test/Reference|1.0799|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANCOVA|||"Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:~H01: uT-uR \< -0.20 uR vs. Ha1: -0.20 uR \</= uT- uR (the lower tail) and H02: uT-uR \>0.25 uR vs. Ha2: uT- uR \</=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS"|"Day 1 superiority to placebo:~Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012"|1.25|.8|<0.05
71939693|NCT02260492|143399362|EQUIVALENCE|Standard bioequivalence 90% confidence bounds set at 0.8-1.25.|Test/Reference|1.0475|||<|0.05|TWO_SIDED|90.0|0.8|1.25|||ANOVA|||Same as the Day 1 analyses|"Week 4 superiority to placebo:~Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035"|1.25|.8|<0.05
71939694|NCT01497938|143399375|NON_INFERIORITY_OR_EQUIVALENCE|pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%|Mean Difference (Final Values)|0.05|||||ONE_SIDED|97.5||0.15|||ANCOVA|||||0.15||
71939695|NCT01497938|143399376|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-588.0|||<|0.025||95.0|||||ANCOVA|||||||<0.025
71939696|NCT00365352|143399377|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.5||||0.0015||95.0|-5.6|-1.3|||ANCOVA||Mean difference was adjusted for Baseline value, treatment pooled sites, and treatment by pool site interaction.|||-1.3|-5.6|0.0015
71939697|NCT00365352|143399378|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.287||||0.0001||95.0|2.338|7.861|||Regression, Logistic|A logistic regression model was used with treatment and pooled center as explanatory factors.||||7.861|2.338|0.0001
71939698|NCT05431153|143399446|OTHER||Ratio of adjusted geometric means|98.83|||||TWO_SIDED|90.0|94.0|103.91|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||103.91|94.00|
71939699|NCT05431153|143399446|OTHER||Ratio of adjusted geometric means|98.02|||||TWO_SIDED|90.0|93.88|102.35|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.35|93.88|
71939700|NCT05431153|143399446|OTHER||Ratio of adjusted geometric means|98.51|||||TWO_SIDED|90.0|91.79|105.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||105.73|91.79|
71693421|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.46|STANDARD_ERROR_OF_MEAN|0.262||0.0817||95.0|-0.06|0.97|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.97|-0.06|0.0817
71693422|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.253||0.1146||95.0|-0.1|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.90|-0.10|0.1146
71693423|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.71|STANDARD_ERROR_OF_MEAN|0.253||0.0054||95.0|0.21|1.21|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.21|0.21|0.0054
71693424|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.261||0.3389||95.0|-0.26|0.76|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.26|0.3389
71693425|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.254||0.5079||95.0|-0.33|0.67|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.67|-0.33|0.5079
71693426|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.265||0.0453||95.0|0.01|1.05|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.01|0.0453
71693427|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.256||0.1622||95.0|-0.15|0.86|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.86|-0.15|0.1622
71939701|NCT05431153|143399447|OTHER||Ratio of adjusted geometric means|96.35|||||TWO_SIDED|90.0|87.48|106.12|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.12|87.48|
71693428|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|0.262||0.0003||95.0|0.45|1.48|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.48|0.45|0.0003
71939702|NCT05431153|143399447|OTHER||Ratio of adjusted geometric means|93.47|||||TWO_SIDED|90.0|85.65|102.0|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||102.00|85.65|
71939703|NCT05431153|143399447|OTHER||Ratio of adjusted geometric means|98.01|||||TWO_SIDED|90.0|89.86|106.9|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.90|89.86|
71939704|NCT05431153|143399448|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|99.55|124.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||124.93|99.55|
71939705|NCT05431153|143399448|OTHER||Ratio of adjusted geometric means|98.38|||||TWO_SIDED|90.0|90.68|106.73|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||106.73|90.68|
71939706|NCT05431153|143399449|OTHER||Ratio of adjusted geometric means|111.52|||||TWO_SIDED|90.0|96.46|128.93|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||128.93|96.46|
71939707|NCT05431153|143399449|OTHER||Ratio of adjusted geometric means|81.39|||||TWO_SIDED|90.0|75.06|88.26|||||Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|||88.26|75.06|
71939708|NCT04828161|143399455|SUPERIORITY||Least square (LS) mean difference|-0.59|STANDARD_ERROR_OF_MEAN|0.138|<|0.001|TWO_SIDED|95.0|-0.86|-0.32|||ANCOVA|||||-0.32|-0.86|<0.001
71939709|NCT04828161|143399455|SUPERIORITY||LS mean difference|-0.33|STANDARD_ERROR_OF_MEAN|0.135||0.014|TWO_SIDED|95.0|-0.6|-0.07|||ANCOVA|||||-0.07|-0.60|0.014
71939710|NCT04828161|143399455|SUPERIORITY||LS mean difference|-0.42|STANDARD_ERROR_OF_MEAN|0.135||0.002|TWO_SIDED|95.0|-0.68|-0.15|||ANCOVA|||||-0.15|-0.68|0.002
71939711|NCT01082952|143399532|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0||||The p value is calculated for the results of ASM proliferation following incubation with eosinophils isolated from patients in each group. p\< 0.05 was considered significant.|ANOVA|Proliferation data was evaluated using two-way factorial ANOVA followed by Bonferroni post hoc test.||||||<0.05
71939712|NCT03093454|143399534|EQUIVALENCE|Linear mixed effects models were used to investigate HADS scores (total, anxiety, and depression), sleep scores, and pain scores. Variables for time point (preoperative/Post-op Day 1/final Post-op Day) \& arm were analyzed. Adjustment for multiple pairwise comparisons used the Scheffe method. Analyses were conducted based on the intent to treat principle. P-values\<0.05 were considered statistically significant. Each time point, the mean and corresponding 95% confidence interval has been plotted.|Odds Ratio (OR)|95.0|STANDARD_DEVIATION|1.0||0.05|TWO_SIDED|95.0||||The p value is calculated and adjusted for multiple comparisons.|Fisher Exact|||Lavender group compared to control group||||0.05
71939713|NCT04540497|143399537|OTHER||Hazard Ratio (HR)|0.13|||||TWO_SIDED|95.0|0.06|0.28|||||Inebilizumab versus placebo|||0.28|0.06|
71939714|NCT04540497|143399544|OTHER||Hazard Ratio (HR)|0.12|||||TWO_SIDED|95.0|0.05|0.26|||||Inebilizumab vs placebo|||0.26|0.05|
71939715|NCT01681030|143399551|SUPERIORITY_OR_OTHER||Proportion|0.923|||||TWO_SIDED|95.0|0.64|0.998|||||CI for EVARREST Group|||0.998|0.640|
71939716|NCT01681030|143399551|SUPERIORITY_OR_OTHER||Proportion|0.333|||||TWO_SIDED|95.0|0.133|0.59|||||CI for Topical Hemostat group|||0.590|0.133|
71939717|NCT01681030|143399551|SUPERIORITY_OR_OTHER||Proportion|0.455|||||TWO_SIDED|95.0|0.167|0.766|||||CI for Standard of Care group|||0.766|0.167|
71939718|NCT01521559|143399585|SUPERIORITY_OR_OTHER||Mean Difference (Net)|26.6||||0.0003|TWO_SIDED|95.0|13.0|40.1||P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200).|Cochran-Mantel-Haenszel||Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA \>20/200).|||40.1|13.0|0.0003
71939719|NCT01521559|143399586|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.5|||<|0.0001|TWO_SIDED|95.0|7.1|14.0|||ANCOVA|||Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||14.0|7.1|<0.0001
71939720|NCT01521559|143399587|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-148.6|||<|0.0001|TWO_SIDED|95.0|-179.8|-117.4|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||-117.4|-179.8|<0.0001
71939721|NCT01521559|143399588|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.0833|TWO_SIDED|95.0|-0.3|5.5|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA \>20/200) as fixed factors.||5.5|-0.3|0.0833
71939722|NCT00520741|143399616|SUPERIORITY_OR_OTHER||Predicted exit rate at 112 days|0.3|||||TWO_SIDED|95.0|0.246|0.355|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.355|0.246|
71939723|NCT00520741|143399618|SUPERIORITY_OR_OTHER||predicted exit rate at 112 days|0.323|||||TWO_SIDED|95.0|0.268|0.378|||Kaplan-Meier|Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.||0.378|0.268|
71939724|NCT02750761|143399636|OTHER|Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.|Geometric Least Squares Mean Ratio|1.12|||||TWO_SIDED|90.0|0.93|1.35|||||The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.|||1.35|0.93|
71939725|NCT00625807|143399717|OTHER||||||>|0.1||||||Cohen's d = 0.5|ANOVA|||ANOVA for group by time interaction||||> 0.1
71939726|NCT00625807|143399718|OTHER|||||||0.103|||||||ANOVA|||||||0.103
71939727|NCT00625807|143399719|OTHER|||||||0.022|||||||t-test, 2 sided|||within group change pre to week 8||||.022
71939728|NCT00625807|143399719|OTHER|within group change from pre to week 8|||||<|0.001|||||||t-test, 2 sided|||||||<.001
71939729|NCT00625807|143399720|OTHER|||||||0.015|||||||t-test, 2 sided|||within group change from pre to week 8||||.015
71939730|NCT00625807|143399720|OTHER|||||||0.53|||||||t-test, 2 sided|||within group change from pre to week 8||||.53
71939731|NCT00625807|143399721|OTHER|||||||0.06|||||||t-test, 2 sided|||within group change from pre to week 8||||.06
71939732|NCT00625807|143399721|OTHER||||||<|0.001|||||||t-test, 2 sided|||within group change from pre to post||||<.001
71939733|NCT00108732|143399725|SUPERIORITY_OR_OTHER||Percent|62.5|||||TWO_SIDED|90.0|48.3|75.3||||||||75.3|48.3|
71939734|NCT00108732|143399726|SUPERIORITY_OR_OTHER||Response rate (percent)|0.0|||||TWO_SIDED|90.0|0.0|7.2||||||||7.2|0|
71939735|NCT00108732|143399727|SUPERIORITY_OR_OTHER||median of difference|0.45||||0.003||95.0|||||Wilcoxon signed rank test|The Wilcoxon signed rank test was used to test the difference between day 4 PSA and day 15 PSA.||||||0.003
71939736|NCT00108732|143399728|SUPERIORITY_OR_OTHER||median of difference|-0.04||||0.02||95.0||||The Wilcoxon signed-rank test was used to test the difference between pre and post-treatment PSA slopes assessed by multiple PSA values on natural log scale using a piecewise linear model with a common knot point at the date of registration.|Wilcoxon signed rank test|||||||0.02
71939737|NCT01984242|143399749|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9819|TWO_SIDED|95.0|0.69|1.45|||Log Rank|||||1.45|0.69|0.9819
71939738|NCT01984242|143399749|SUPERIORITY||Hazard Ratio (HR)|1.19||||0.358|TWO_SIDED|95.0|0.82|1.71|||Log Rank|||||1.71|0.82|0.3580
71939739|NCT01984242|143399751|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0952||95.0|0.38|1.08|||Log Rank|||||1.08|0.38|0.0952
71939740|NCT01984242|143399751|SUPERIORITY||Hazard Ratio (HR)|1.03||||0.9172|TWO_SIDED|95.0|0.63|1.67|||Log Rank|||||1.67|0.63|0.9172
71939741|NCT01984242|143399753|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0153|TWO_SIDED|95.0|0.26|0.87|||Log Rank|||||0.87|0.26|0.0153
71939742|NCT01984242|143399753|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.5545|TWO_SIDED|95.0|0.48|1.46|||Log Rank|||||1.46|0.48|0.5545
71939743|NCT01984242|143399755|SUPERIORITY||Hazard Ratio (HR)|0.49||||0.0086|TWO_SIDED|95.0|0.28|0.84|||Log Rank|||||0.84|0.28|0.0086
71939744|NCT01984242|143399755|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.7675||95.0|0.56|1.53|||Log Rank|||||1.53|0.56|0.7675
71693429|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.26||0.0383||95.0|0.03|1.05|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.05|0.03|0.0383
71939745|NCT01984242|143399757|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.1973||95.0|0.44|1.18|||Log Rank|||||1.18|0.44|0.1973
71939746|NCT01984242|143399757|SUPERIORITY||Hazard Ratio (HR)|1.07||||0.7738|TWO_SIDED|95.0|0.65|1.76|||Log Rank|||||1.76|0.65|0.7738
71939747|NCT01984242|143399759|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.083||95.0|0.43|1.06|||Log Rank|||||1.06|0.43|0.0830
71939748|NCT01984242|143399759|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.7141|TWO_SIDED|95.0|0.7|1.69|||Log Rank|||||1.69|0.70|0.7141
71939749|NCT01984242|143399761|SUPERIORITY||Hazard Ratio (HR)|0.82||||0.2541||95.0|0.59|1.15|||Log Rank|||||1.15|0.59|0.2541
71939750|NCT01984242|143399761|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.3103|TWO_SIDED|95.0|0.86|1.63|||Log Rank|||||1.63|0.86|0.3103
71939751|NCT01984242|143399763|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0351|TWO_SIDED|95.0|0.37|0.97|||Log Rank|||||0.97|0.37|0.0351
71939752|NCT01984242|143399763|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.9769||95.0|0.64|1.54|||Log Rank|||||1.54|0.64|0.9769
71939753|NCT01984242|143399764|SUPERIORITY||Difference in response rates|2.97||||0.6492|TWO_SIDED|95.0|-10.68|16.62|||Cochran-Mantel-Haenszel|||||16.62|-10.68|0.6492
71939754|NCT01984242|143399764|SUPERIORITY||Difference in response rates|-3.47||||0.5433||95.0|-16.63|9.69|||Cochran-Mantel-Haenszel|||||9.69|-16.63|0.5433
71939755|NCT01984242|143399765|SUPERIORITY||Difference in response rates|19.33||||0.0141|TWO_SIDED|95.0|-0.28|38.94|||Cochran-Mantel-Haenszel|||||38.94|-0.28|0.0141
71939756|NCT01984242|143399765|SUPERIORITY||Difference in response rates|1.11||||0.8719|TWO_SIDED|95.0|-17.02|19.24|||Cochran-Mantel-Haenszel|||||19.24|-17.02|0.8719
71939757|NCT01984242|143399766|SUPERIORITY||Difference in response rates|1.98||||0.8068|TWO_SIDED|95.0|-12.04|16.0|||Cochran-Mantel-Haenszel|||||16.00|-12.04|0.8068
71693430|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.253||0.4495||95.0|-0.31|0.69|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.69|-0.31|0.4495
71693431|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.263||0.0135||95.0|0.14|1.17|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0135
71939758|NCT01984242|143399766|SUPERIORITY||Difference in response rates|-9.37||||0.1321||95.0|-22.61|3.87|||Cochran-Mantel-Haenszel|||||3.87|-22.61|0.1321
71939759|NCT01984242|143399767|SUPERIORITY||Difference in response rates|19.67||||0.0199|TWO_SIDED|95.0|-0.1|39.44|||Cochran-Mantel-Haenszel|||||39.44|-0.10|0.0199
71939760|NCT01984242|143399767|SUPERIORITY||Difference in response rates|-2.41||||0.7836|TWO_SIDED|95.0|-20.5|15.68|||Cochran-Mantel-Haenszel|||||15.68|-20.50|0.7836
71939761|NCT01984242|143399768|SUPERIORITY||Difference in response rates|3.96||||0.6231|TWO_SIDED|95.0|-10.23|18.15|||Cochran-Mantel-Haenszel|||||18.15|-10.23|0.6231
71939762|NCT01984242|143399768|SUPERIORITY||Difference in response rates|-8.42||||0.1816|TWO_SIDED|95.0|-21.86|5.02|||Cochran-Mantel-Haenszel|||||5.02|-21.86|0.1816
71939763|NCT01984242|143399769|SUPERIORITY||Difference in response rates|22.0||||0.0111|TWO_SIDED|95.0|2.11|41.89|||Cochran-Mantel-Haenszel|||||41.89|2.11|0.0111
71939764|NCT01984242|143399769|SUPERIORITY||Difference in response rates|-2.22||||0.8209|TWO_SIDED|95.0|-20.63|16.19|||Cochran-Mantel-Haenszel|||||16.19|-20.63|0.8209
71939765|NCT01984242|143399771|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0863||95.0|0.5|1.05|||Log Rank|||||1.05|0.50|0.0863
71939766|NCT01984242|143399771|SUPERIORITY||Hazard Ratio (HR)|1.1||||0.5922|TWO_SIDED|95.0|0.77|1.57|||Log Rank|||||1.57|0.77|0.5922
71939767|NCT01984242|143399773|SUPERIORITY||Hazard Ratio (HR)|0.43||||0.0021||95.0|0.25|0.75|||Log Rank|||||0.75|0.25|0.0021
71939768|NCT01984242|143399773|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.6566|TWO_SIDED|95.0|0.56|1.44|||Log Rank|||||1.44|0.56|0.6566
71939769|NCT01984242|143399781|SUPERIORITY||Hazard Ratio (HR)|1.3||||0.2867|TWO_SIDED|95.0|0.8|2.13|||Log Rank|||||2.13|0.80|0.2867
71939770|NCT01984242|143399781|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.8039||95.0|0.65|1.73|||Log Rank|||||1.73|0.65|0.8039
71939771|NCT01984242|143399783|SUPERIORITY||Hazard Ratio (HR)|0.91||||0.7879|TWO_SIDED|95.0|0.47|1.78|||Log Rank|||||1.78|0.47|0.7879
71939772|NCT01984242|143399783|SUPERIORITY||Hazard Ratio (HR)|0.96||||0.9065|TWO_SIDED|95.0|0.52|1.8|||Log Rank|||||1.80|0.52|0.9065
71939773|NCT04543136|143399798|SUPERIORITY||Mean Difference (Final Values)|45.0||||0.074|TWO_SIDED|95.0|-4.5|94.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||94.5|-4.5|0.074
71939774|NCT04543136|143399798|SUPERIORITY||Mean Difference (Final Values)|58.8||||0.022|TWO_SIDED|95.0|8.5|109.1||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||109.1|8.5|0.022
71939775|NCT04543136|143399798|SUPERIORITY||Mean Difference (Final Values)|-13.8||||0.587|TWO_SIDED|95.0|-64.2|36.6||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||36.6|-64.2|0.587
71939776|NCT04543136|143399799|SUPERIORITY||Mean Difference (Final Values)|54.9||||0.03|TWO_SIDED|95.0|5.3|104.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||104.4|5.3|0.030
71939777|NCT04543136|143399799|SUPERIORITY||Mean Difference (Final Values)|61.8||||0.015|TWO_SIDED|95.0|12.5|111.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||111.2|12.5|0.015
71939778|NCT04543136|143399799|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.78|TWO_SIDED|95.0|-56.5|42.5||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||42.5|-56.5|0.780
71939779|NCT04543136|143399800|SUPERIORITY||Mean Difference (Final Values)|-13.3||||0.281|TWO_SIDED|95.0|-37.9|11.2||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||11.2|-37.9|0.281
71939780|NCT04543136|143399800|SUPERIORITY||Mean Difference (Final Values)|6.6||||0.597|TWO_SIDED|95.0|-18.3|31.7||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.7|-18.3|0.597
71939781|NCT04543136|143399800|SUPERIORITY||Mean Difference (Final Values)|-20.0||||0.116|TWO_SIDED|95.0|-45.1|5.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||5.0|-45.1|0.116
71939782|NCT04543136|143399801|SUPERIORITY||Mean Difference (Final Values)|3.3||||0.787|TWO_SIDED|95.0|-21.2|27.9||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||27.9|-21.2|0.787
71939783|NCT04543136|143399801|SUPERIORITY||Mean Difference (Final Values)|6.8||||0.576|TWO_SIDED|95.0|-17.6|31.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||31.3|-17.6|0.576
71939784|NCT04543136|143399801|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.775|TWO_SIDED|95.0|-28.1|21.0||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||21.0|-28.1|0.775
71939785|NCT04543136|143399802|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.766|TWO_SIDED|95.0|-0.7|0.52||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.52|-0.70|0.766
71939786|NCT04543136|143399802|SUPERIORITY||Mean Difference (Final Values)|-0.68||||0.032|TWO_SIDED|95.0|-1.3|-0.06||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||-0.06|-1.30|0.032
71939787|NCT04543136|143399802|SUPERIORITY||Mean Difference (Final Values)|0.59||||0.063|TWO_SIDED|95.0|-0.03|1.21||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.21|-0.03|0.063
71939788|NCT04543136|143399803|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.213|TWO_SIDED|95.0|-0.12|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.12|0.213
71939789|NCT04543136|143399803|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.291|TWO_SIDED|95.0|-0.16|0.51||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.51|-0.16|0.291
71939790|NCT04543136|143399803|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.868|TWO_SIDED|95.0|-0.31|0.36||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.36|-0.31|0.868
71939791|NCT04543136|143399804|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.661|TWO_SIDED|95.0|-0.35|0.55||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.55|-0.35|0.661
71939792|NCT04543136|143399804|SUPERIORITY||Mean Difference (Final Values)|-0.29||||0.218|TWO_SIDED|95.0|-0.75|0.17||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.17|-0.75|0.218
71939793|NCT04543136|143399804|SUPERIORITY||Mean Difference (Final Values)|0.39||||0.1|TWO_SIDED|95.0|-0.08|0.85||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.85|-0.08|0.100
71939794|NCT04543136|143399805|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.701|TWO_SIDED|95.0|-0.8|0.54||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.54|-0.80|0.701
71939795|NCT04543136|143399805|SUPERIORITY||Mean Difference (Final Values)|-0.27||||0.438|TWO_SIDED|95.0|-0.96|0.42||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.42|-0.96|0.438
71939796|NCT04543136|143399805|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.689|TWO_SIDED|95.0|-0.55|0.83||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.83|-0.55|0.689
71939797|NCT04543136|143399806|SUPERIORITY||Mean Difference (Final Values)|-0.31||||0.309|TWO_SIDED|95.0|-0.92|0.3||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.30|-0.92|0.309
71939798|NCT04543136|143399806|SUPERIORITY||Mean Difference (Final Values)|-0.49||||0.109|TWO_SIDED|95.0|-1.1|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.10|0.109
71939799|NCT04543136|143399806|SUPERIORITY||Mean Difference (Final Values)|0.18||||0.555|TWO_SIDED|95.0|-0.43|0.79||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.79|-0.43|0.555
71693432|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.254||0.1423||95.0|-0.13|0.87|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.87|-0.13|0.1423
71939800|NCT04543136|143399807|SUPERIORITY||Mean Difference (Final Values)|-0.02||||0.896|TWO_SIDED|95.0|-0.35|0.31||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.31|-0.35|0.896
71939801|NCT04543136|143399807|SUPERIORITY||Mean Difference (Final Values)|-0.16||||0.32|TWO_SIDED|95.0|-0.49|0.16||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.16|-0.49|0.320
71939802|NCT04543136|143399807|SUPERIORITY||Mean Difference (Final Values)|0.14||||0.39|TWO_SIDED|95.0|-0.19|0.47||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.47|-0.19|0.390
71939803|NCT04543136|143399808|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.802|TWO_SIDED|95.0|-0.51|0.4||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.40|-0.51|0.802
71939804|NCT04543136|143399808|SUPERIORITY||Mean Difference (Final Values)|-0.4||||0.082|TWO_SIDED|95.0|-0.85|0.05||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.05|-0.85|0.082
71939805|NCT04543136|143399808|SUPERIORITY||Mean Difference (Final Values)|0.34||||0.137|TWO_SIDED|95.0|-0.11|0.8||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.80|-0.11|0.137
71939806|NCT04543136|143399809|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.525|TWO_SIDED|95.0|-0.89|0.46||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.46|-0.89|0.525
71939807|NCT04543136|143399809|SUPERIORITY||Mean Difference (Final Values)|-0.56||||0.098|TWO_SIDED|95.0|-1.24|0.11||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||0.11|-1.24|0.098
71939808|NCT04543136|143399809|SUPERIORITY||Mean Difference (Final Values)|0.35||||0.306|TWO_SIDED|95.0|-0.33|1.02||The P-values were not adjusted for multiple comparisons.|Mixed Models Analysis|Subject was included as a random effect, 'Visit' (Visit 1, 2 and 3) and 'Treatment' (comparator, Variant 1 and Variant 2) as fixed effects.||Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.||1.02|-0.33|0.306
71939809|NCT00865709|143399810|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.884||||0.2309|TWO_SIDED|95.0|0.635|1.231||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PFS events would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing the null hypothesis H0: HR ≥ 1 versus the alternative hypothesis H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population, defined as all subjects who were randomized to treatment.||1.231|0.635|0.2309
71939810|NCT00865709|143399812|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.829||||0.1437|TWO_SIDED|95.0|0.586|1.174||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PDs would provide a \> 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing H0: HR ≥ 1 versus H1: HR \< 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).||1.174|0.586|0.1437
71939811|NCT00865709|143399813|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||1-sided p-value from the Cochran-Mantel-Haenszel test, adjusting for the stratification factors of # metastatic sites and liver metastasis determined by Principal Investigator|Cochran-Mantel-Haenszel|||The proportion of subjects achieving overall response (CR or PR), when confirmation of response was not required, was estimated with a 95% confidence interval for each treatment group. The treatment groups were compared with respect to overall response rate using the Cochran-Mantel-Haenszel test, adjusting for the stratification factors.||||0.023
71939812|NCT00429923|143399815|SUPERIORITY_OR_OTHER|||||||0.0014||95.0|||||Mantel Haenszel|||||||0.0014
71939813|NCT01041781|143399819|SUPERIORITY||Hazard Ratio (HR)|1.076||||0.5346|TWO_SIDED|95.0|0.853|1.367|||Log Rank|||||1.367|0.853|0.5346
71939814|NCT01041781|143399823|SUPERIORITY|||||||0.0049|||||||Log Rank|||||||0.0049
71761118|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|1.4||||0.2863|TWO_SIDED|95.0|-1.18|3.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Cognitive Functioning|||3.97|-1.18|0.2863
71939815|NCT01041781|143399824|SUPERIORITY|||||||0.0131|||||||Log Rank|||||||0.0131
71939816|NCT01041781|143399825|SUPERIORITY|||||||0.0322|||||||Log Rank|||||||0.0322
71939817|NCT00662129|143399840|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||||||0.003
71939818|NCT02099461|143399855|SUPERIORITY_OR_OTHER||LS Mean|0.15||||0.2966|TWO_SIDED|95.0|-0.136|0.441|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.441|-0.136|0.2966
71939819|NCT02099461|143399855|SUPERIORITY_OR_OTHER||LS Mean|-0.16||||0.2769|TWO_SIDED|95.0|-0.447|0.13|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.130|-0.447|0.2769
71939820|NCT02099461|143399855|SUPERIORITY_OR_OTHER||LS Mean|-0.09||||0.5238|TWO_SIDED|95.0|-0.373|0.191|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.191|-0.373|0.5238
71939821|NCT02099461|143399855|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.31||||0.1343|TWO_SIDED|95.0|-0.72|0.098|||ANCOVA||Denosumab 60 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.098|-0.720|0.1343
71939822|NCT02099461|143399855|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.24||||0.2345|TWO_SIDED|95.0|-0.646|0.161|||ANCOVA||Denosumab 120 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.||0.161|-0.646|0.2345
71939823|NCT00720122|143399858|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.00558|STANDARD_ERROR_OF_MEAN|0.00653||0.4|TWO_SIDED|95.0|-0.0081|0.0193|||Paired t-test|||A paired t-test was performed. The null hypothesis was that bone density would decrease over 6 months in females with anorexia nervosa, as observed in life course studies.||0.0193|-0.0081|0.40
71939824|NCT01048333|143399876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.002|TWO_SIDED|95.0|1.31|3.35|||Regression, Cox|||||3.35|1.31|0.002
71939825|NCT01048333|143399876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.534||||0.001|TWO_SIDED|95.0|3.55|12.02|||Regression, Cox|||||12.02|3.55|0.001
71939826|NCT01048333|143399876|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.127||||0.001|TWO_SIDED|95.0|1.77|5.52|||Regression, Cox|||||5.52|1.77|0.001
71939827|NCT01396044|143399878|SUPERIORITY_OR_OTHER|||||||0.27|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
71939828|NCT01396044|143399879|SUPERIORITY_OR_OTHER|||||||0.093|TWO_SIDED|95.0|||||t-test, 2 sided|||||||0.093
71939829|NCT01396044|143399880|SUPERIORITY_OR_OTHER|||||||0.17|TWO_SIDED|95.0|||||Chi-squared|||||||0.17
71939830|NCT01396044|143399881|SUPERIORITY_OR_OTHER|||||||0.27||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.27
71939831|NCT01396044|143399882|SUPERIORITY_OR_OTHER|||||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.36
71939832|NCT01396044|143399884|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0|||||Chi-squared|||||||0.002
71939833|NCT00955747|143399887|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5|STANDARD_DEVIATION|1.4|<|0.05|TWO_SIDED|95.0|||||ANCOVA|||All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.||||<0.05
71939834|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.282|||TWO_SIDED|95.0|-1.2|-0.1|||||Day 7|||-0.1|-1.2|
71939835|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.308|||TWO_SIDED|95.0|-2.0|-0.7|||||Day 15|||-0.7|-2.0|
71939836|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|0.383|||TWO_SIDED|95.0|-3.2|-1.7|||||Day 29|||-1.7|-3.2|
71939837|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|0.384|||TWO_SIDED|95.0|-3.7|-2.1|||||Day 43|||-2.1|-3.7|
71939838|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.2|STANDARD_ERROR_OF_MEAN|0.393|||TWO_SIDED|95.0|-4.0|-2.4|||||Day 57|||-2.4|-4.0|
71939839|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|0.454|||TWO_SIDED|95.0|-4.7|-2.9|||||Day 85|||-2.9|-4.7|
71939840|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|0.472|||TWO_SIDED|95.0|-5.4|-3.5|||||Day 113|||-3.5|-5.4|
71939841|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.492|||TWO_SIDED|95.0|-5.8|-3.8|||||Day 141|||-3.8|-5.8|
71939842|NCT00767325|143399890|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.8|STANDARD_ERROR_OF_MEAN|0.473|||TWO_SIDED|95.0|-5.8|-3.9|||||Day 169|||-3.9|-5.8|
71939843|NCT00996736|143399897|NON_INFERIORITY_OR_EQUIVALENCE|The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|Mean Difference (Net)|-0.18||||0.006|TWO_SIDED|95.0|-0.3|-0.05|||Regression, Linear|||||-0.05|-0.30|0.006
71939844|NCT01691508|143399936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.39||||0.008|TWO_SIDED|95.0|1.25|4.56|||Proportional odds model|||||4.56|1.25|0.008
71939845|NCT03238677|143399946|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.132|TWO_SIDED|95.0|-23.2|3.1|||Mixed Models Analysis|||Main effect of biofeedback at 10 weeks||3.1|-23.2|.132
71939846|NCT03238677|143399946|SUPERIORITY||Mean Difference (Final Values)|-13.7||||0.028|TWO_SIDED|95.0|-25.9|-1.5|||Mixed Models Analysis|||Main effect of Practice Distribution at 10 weeks||-1.5|-25.9|.028
71939847|NCT03238677|143399946|SUPERIORITY||Mean Difference (Final Values)|-10.0||||0.187|TWO_SIDED|95.0|-24.9|5.0|||Mixed Models Analysis|||Main effect comparing telepractice vs face-to-face treatment||5.0|-24.9|.187
71939848|NCT03238677|143399946|SUPERIORITY||Mean Difference (Final Values)|20.22||||0.125|TWO_SIDED|95.0|-5.8|46.3|||Mixed Models Analysis|||Interaction of biofeedback and practice distribution at 10 weeks|η2 =.054|46.3|-5.8|.125
71939849|NCT02433665|143399949|NON_INFERIORITY|The primary end point for this study was a comparison between fixed-dose and customized-dose contrast material injection CT protocols for vascular and parenchymal enhancement by using a noninferiority approach. The limit of noninferiority was set at 0.1 before the initiation of the study on the basis of a similar study that examined contrast media dose optimization for CT angiography examinations.|Odds Ratio, log|0.75|STANDARD_DEVIATION|0.35|>|0.05|TWO_SIDED|0.38|||||Mixed Models Analysis|||||||>0.05
71939850|NCT01439165|143399959|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.0|||||TWO_SIDED|95.0|-0.4|1.2||||||Comparison of anti-tetanus seroprotection rate between the two groups||1.2|-0.4|
71939851|NCT01439165|143399959|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of seroprotection rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|0.42|||||TWO_SIDED|95.0|-0.3|2.1||||||Comparison of anti-diphtheria seroprotection rates between the two groups||2.1|-0.3|
71939852|NCT01439165|143399960|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-7.12|||||TWO_SIDED|95.0|-12.0|-1.7||||||Comparison of the anti-tetanus booster response rates between the two groups||-1.7|-12.0|
71939853|NCT01439165|143399960|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) in Adacel-Td Adsorbed|-0.95|||||TWO_SIDED|95.0|-5.4|4.0||||||Comparison of the anti-diphteria booster response rates between the two groups||4.0|-5.4|
71939854|NCT01439165|143399961|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC ratio (Adacel/Historical Control)|1.04|||||TWO_SIDED|95.0|0.92|1.18||||||Comparison of anti-pertussis toxoid GMCs between Adacel and historical control groups||1.18|0.92|
71939855|NCT01439165|143399961|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|5.22|||||TWO_SIDED|95.0|4.51|6.05||||||Comparison of the anti-FHA GMCs between Adacel and historical Control groups||6.05|4.51|
71939856|NCT01439165|143399961|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.94|||||TWO_SIDED|95.0|2.46|3.51||||||Comparison of the anti-Pertactin GMCs between Adacel and historical Control groups||3.51|2.46|
71939857|NCT01439165|143399961|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is \> 0.66|GMC Ratio (Adacel/Historical Control)|2.18|||||TWO_SIDED|95.0|1.84|2.6||||||Comparison of the post-vaccination anti-Fimbriae (types 2 and 3) GMCs between Adacel and historical Control groups||2.60|1.84|
71939858|NCT01439165|143399962|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|16.12|||||TWO_SIDED|95.0|13.27|18.73||||||comparison of anti-pertussis toxoid booster response rates was performed between the Adacel and historical groups||18.73|13.27|
71939859|NCT01439165|143399962|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10%|Difference (%) Adacel-Expected Booster|-4.21|||||TWO_SIDED|95.0|-7.23|-1.34||||||Comparison of the anti-FHA booster response rates between the Adacel and historical groups||-1.34|-7.23|
71939860|NCT01439165|143399962|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-18.61|||||TWO_SIDED|95.0|-21.7|-15.6||||||Comparison of the anti-Pertactin booster response rates between Adacel and historical groups||-15.6|-21.7|
71939861|NCT01439165|143399962|NON_INFERIORITY|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is \> -10% .|Difference (%) Adacel-Expected Booster|-19.07|||||TWO_SIDED|95.0|-22.3|-16.0||||||Comparison of the anti-Fimbriae (types 2 and 3) booster response rates between Adacel and historical groups||-16.0|-22.3|
71939862|NCT01024738|143399972|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71939863|NCT01700621|143399984|NON_INFERIORITY|A noninferiority margin of -10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.|Seroconversion proportion difference|1.1|||||TWO_SIDED|95.0|-6.9|9.0||||||||9.0|-6.9|
71939864|NCT01626079|143400075|NON_INFERIORITY|Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide \> 95% power to reject the null hypothesis at the one-sided significance level of 5%.|Kaplan Meier|0.966|STANDARD_ERROR_OF_MEAN|0.011|<|0.0001|ONE_SIDED|95.0|0.948||||Z test Using Kaplan Meier Survival|P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance|||||0.948|<0.0001
71939865|NCT01626079|143400108|SUPERIORITY||Hazard Ratio (HR)|0.76|||<|0.02|TWO_SIDED|95.0|0.6|0.96|||Joint Fraility Model|||||0.96|0.60|<0.02
71939866|NCT01626079|143400109|SUPERIORITY||Win Ratio|1.61|||<|0.0001|TWO_SIDED|95.0|1.29|2.04|||Finkelstein-Schoenfeld Analysis|||||2.04|1.29|<0.0001
71939867|NCT00918567|143400465|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p \< .10.|Mixed Models Analysis|Tukey-Kramer adjustments for post-hoc differences of least squares comparisons||||||<.05
71939868|NCT00918567|143400466|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.51|<|0.05|TWO_SIDED|||||Also examined marginal effects, defined as p\<.10|Mixed Models Analysis|||||||<.05
71939869|NCT00918567|143400467|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.6|<|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
71939870|NCT00918567|143400468|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.09|<|0.05|TWO_SIDED|||||Also estimated marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
71939871|NCT00918567|143400469|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.07|<|0.05|TWO_SIDED|||||also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||<.05
71939872|NCT00918567|143400470|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.18|>|0.05|TWO_SIDED|||||Also tested marginal effects defined as p\<.10|Mixed Models Analysis|||||||>.05
71939873|NCT00918567|143400471|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.2|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
71939874|NCT00918567|143400472|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.05|STANDARD_ERROR_OF_MEAN|1.7|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<0.05
71939875|NCT00918567|143400473|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|1.8|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
71939876|NCT00918567|143400474|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|<|0.05|TWO_SIDED|||||Also tested marginal effect (p\<.10)|Mixed Models Analysis|||||||<.05
71939877|NCT00918567|143400475|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.19|<|0.05|TWO_SIDED|||||Also tested marginal effects (p\<.10)|Mixed Models Analysis|||||||<.05
71761119|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-1.97||||0.0932|TWO_SIDED|95.0|-4.28|0.33||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Constipation|||0.33|-4.28|0.0932
71939878|NCT01055223|143400483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.42|||||TWO_SIDED|95.0|1.13|1.78|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.78|1.13|
71939879|NCT01055223|143400483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19|||||TWO_SIDED|95.0|0.93|1.52|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.52|0.93|
71939880|NCT01055223|143400483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.53|||||TWO_SIDED|95.0|0.78|2.98|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||2.98|0.78|
71939881|NCT01055223|143400483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.46|||||TWO_SIDED|95.0|0.74|2.89|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||2.89|0.74|
71939882|NCT01055223|143400483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.01|||||TWO_SIDED|95.0|0.18|22.14|||||Undadjusted Odds Ratio. Reference Group: TZD alone.|||22.14|0.18|
71939883|NCT01055223|143400483|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.34|||||TWO_SIDED|95.0|0.12|15.5|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.50|0.12|
71939884|NCT01055223|143400484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.41|||||TWO_SIDED|95.0|1.05|1.89|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.89|1.05|
71939885|NCT01055223|143400484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2|||||TWO_SIDED|95.0|0.88|1.65|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.65|0.88|
71939886|NCT01055223|143400484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.58|||||TWO_SIDED|95.0|0.69|3.6|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||3.60|0.69|
71939887|NCT01055223|143400484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63|||||TWO_SIDED|95.0|0.7|3.81|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||3.81|0.70|
71939888|NCT01055223|143400484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71939889|NCT01055223|143400484|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71939890|NCT01055223|143400485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.29|||||TWO_SIDED|95.0|0.92|1.79|||||Unadjusted Odds Ratio. Reference Group: TZD alone.|||1.79|0.92|
71939891|NCT01055223|143400485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.01|||||TWO_SIDED|95.0|0.71|1.45|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.45|0.71|
71939892|NCT01055223|143400485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.44|||||TWO_SIDED|95.0|0.1|1.9|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.90|0.10|
71939893|NCT01055223|143400485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.35|||||TWO_SIDED|95.0|0.08|1.54|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.54|0.08|
71939894|NCT01055223|143400485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.99|||||TWO_SIDED|95.0|0.18|21.93|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||21.93|0.18|
71939895|NCT01055223|143400485|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05|||||TWO_SIDED|95.0|0.09|12.36|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||12.36|0.09|
71939896|NCT01055223|143400486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.23|||||TWO_SIDED|95.0|0.8|1.88|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||1.88|0.80|
71939897|NCT01055223|143400486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.62|1.57|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||1.57|0.62|
71939898|NCT01055223|143400486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71939899|NCT01055223|143400486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71939900|NCT01055223|143400486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71939901|NCT01055223|143400486|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates|||0.00|0.00|
71939902|NCT01055223|143400487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.46|||||TWO_SIDED|95.0|1.53|19.45|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||19.45|1.53|
71939903|NCT01055223|143400487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.19|||||TWO_SIDED|95.0|0.64|15.86|||||Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||15.86|0.64|
71939904|NCT01055223|143400487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71939905|NCT01055223|143400487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71939906|NCT01055223|143400487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71939907|NCT01055223|143400487|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71939908|NCT01055223|143400488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.26|||||TWO_SIDED|95.0|0.66|80.35|||||Unadjusted Odds Ratio. Reference group: TZD alone.|||80.35|0.66|
71939909|NCT01055223|143400488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78|||||TWO_SIDED|95.0|0.03|96.47|||||Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates.|||96.47|0.03|
71939910|NCT01055223|143400488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference Group: TZD alone.|||0.00|0.00|
71939911|NCT01055223|143400488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71939912|NCT01055223|143400488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn't converge. Reference group: TZD alone.|||0.00|0.00|
71939913|NCT01055223|143400488|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||Small numbers model didn't converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.|||0.00|0.00|
71939914|NCT02799602|143400494|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.675|||<|0.0001|TWO_SIDED|95.0|0.568|0.801||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.801|0.568|<0.0001
71939915|NCT02799602|143400497|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.357|||<|0.0001|TWO_SIDED|95.0|0.302|0.421||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.421|0.302|<0.0001
71939916|NCT02799602|143400499|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.792||||0.0058|TWO_SIDED|95.0|0.66|0.95||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.950|0.660|0.0058
71939917|NCT02799602|143400501|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.609|||<|0.0001|TWO_SIDED|95.0|0.516|0.718||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.718|0.516|<0.0001
71939918|NCT02799602|143400503|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.712||||0.0081|TWO_SIDED|95.0|0.539|0.94||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.940|0.539|0.0081
71939919|NCT02799602|143400505|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio, log|0.388|||<|0.0001|TWO_SIDED|95.0|0.328|0.458||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.458|0.328|<0.0001
71939920|NCT02799602|143400507|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|1.043||||0.7073|TWO_SIDED|95.0|0.894|1.217||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|1.217|0.894|0.7073
71939921|NCT02799602|143400509|SUPERIORITY|Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|Hazard Ratio (HR)|0.688||||0.0037|TWO_SIDED|95.0|0.523|0.906||One-sided p-value.|Log Rank||||One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).|0.906|0.523|0.0037
71939922|NCT00329602|143400527|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||P-value is for Week 12.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.039
71939923|NCT00329602|143400527|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||P-value is for Week 26.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.||||||0.023
71939924|NCT02579096|143400542|NON_INFERIORITY|A non-inferiority bound of 8% was established during the trial design; a one-sided alpha level was set at 0.05.|Risk Difference (RD)|-7.0|||<|0.001|ONE_SIDED|95.0||-1.2|||t-test, 1 sided|||One-sided null hypothesis posited that allopurinol was inferior to febuxostat. The proportions of participants with ≥ 1 gout flare during phase 3 were compared between the two treatments.||-1.2||<0.001
71939925|NCT02275364|143400543|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|15.28|||<|0.0001|TWO_SIDED|95.0|12.32|18.25||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||18.25|12.32|<0.0001
71939926|NCT02275364|143400544|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.93||||0.7366|TWO_SIDED|95.0|-6.43|4.57||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||4.57|-6.43|0.7366
71939927|NCT02275364|143400545|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|1533.74||||0.0004|TWO_SIDED|95.0|794.16|2273.32||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2273.32|794.16|0.0004
71939928|NCT02275364|143400546|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|-0.46||||0.7278|TWO_SIDED|95.0|-3.06|2.14||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||2.14|-3.06|0.7278
71939929|NCT02275364|143400547|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|191.72||||0.1639|TWO_SIDED|95.0|-78.62|462.06||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||462.06|-78.62|0.1639
71939930|NCT02275364|143400548|SUPERIORITY_OR_OTHER||Adjusted Mean Difference|0.02||||0.4621|TWO_SIDED|95.0|-0.03|0.07||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.|||0.07|-0.03|0.4621
71939931|NCT00663871|143400605|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.04||||0.59|TWO_SIDED|95.0|-0.27|0.19|||ANOVA|||||0.19|-0.27|0.59
71939932|NCT00663871|143400606|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.05||||0.21|TWO_SIDED|95.0|-0.24|0.19|||ANOVA|||||0.19|-0.24|0.21
71939933|NCT00663871|143400607|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.02||||0.92|TWO_SIDED|95.0|0.69|1.5||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Negative Affect scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||1.50|0.69|0.92
71939934|NCT00663871|143400608|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.12||||0.86|TWO_SIDED|95.0|-1.21|1.44||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||1.44|-1.21|0.86
71939935|NCT00663871|143400609|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.31||||0.63|TWO_SIDED|95.0|-1.57|0.94||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.94|-1.57|0.63
71939936|NCT00663871|143400610|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.32||||0.5|TWO_SIDED|95.0|-1.25|0.61||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.61|-1.25|0.50
71939937|NCT00663871|143400611|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.33||||0.25|TWO_SIDED|95.0|-0.23|0.88||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.88|-0.23|0.25
71939938|NCT00663871|143400612|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.52|TWO_SIDED|95.0|-1.83|0.92||The model included effects of treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.92|-1.83|0.52
71939939|NCT00663871|143400613|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.22||||0.52|TWO_SIDED|95.0|0.67|2.24||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time. The Type A personality scores were categorized by quartiles of the baseline measures.|Mixed Models Analysis|Generalized Linear Mixed Modeling was used with a multinomial distribution with cumulative link.||||2.24|0.67|0.52
71939940|NCT00663871|143400614|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.03||||0.68|TWO_SIDED|95.0|-0.16|0.1||The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mixed Models Analysis|||||0.10|-0.16|0.68
71939941|NCT00663871|143400615|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.17||||0.16|TWO_SIDED|95.0|-0.41|0.07|||Mixed Models Analysis|||||0.07|-0.41|0.16
71939942|NCT00663871|143400616|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.05||||0.59|TWO_SIDED|95.0|-0.24|0.14|||Mixed Models Analysis|||||0.14|-0.24|0.59
71693433|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.76|STANDARD_ERROR_OF_MEAN|0.259||0.0035||95.0|0.25|1.27|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.27|0.25|0.0035
71939943|NCT00663871|143400617|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.06||||0.35|TWO_SIDED|95.0|-0.06|0.18|||Mixed Models Analysis|||||0.18|-0.06|0.35
71939944|NCT00663871|143400618|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|0.04||||0.74|TWO_SIDED|95.0|-0.18|0.25|||Mixed Models Analysis|||||0.25|-0.18|0.74
71939945|NCT00663871|143400619|SUPERIORITY_OR_OTHER_LEGACY|The model included effects for treatment (fish oil, placebo), time (baseline, post-intervention), and interaction terms of treatment with time.|Mean Difference (Net)|-0.1||||0.28|TWO_SIDED|95.0|-0.27|0.08|||Mixed Models Analysis|||||0.08|-0.27|0.28
71939946|NCT00663871|143400620|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.15||||0.76|TWO_SIDED|95.0|-0.09|0.39|||Repeated Measures MANOVA|||||0.39|-0.09|0.76
71939947|NCT00663871|143400621|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.06||||0.62|TWO_SIDED|95.0|-0.18|0.3|||Repeated Measures MANOVA|||||0.30|-0.18|0.62
71939948|NCT00663871|143400622|SUPERIORITY_OR_OTHER_LEGACY||standardized mean difference|0.03||||0.42|TWO_SIDED|95.0|-0.21|0.26|||Repeated Measures MANOVA|||||0.26|-0.21|0.42
71939949|NCT00663871|143400623|SUPERIORITY_OR_OTHER_LEGACY||Standardized mean difference|-0.06||||0.54|TWO_SIDED|95.0|-0.3|0.18|||Repeated Measures MANOVA|Repeated Measures MANOVA||||0.18|-0.30|0.54
71939950|NCT03384745|143400638|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 25 (48.1% \[34.0-62.4\], p\<0.0001) of 52 participants in the M1095 30mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71939951|NCT03384745|143400638|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 44 (84.6% \[71.9-93.1\], p\<0.0001) of 52 participants in the M1095 60mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71693434|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.66|STANDARD_ERROR_OF_MEAN|0.261||0.0125||95.0|0.14|1.17|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0125
71693435|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.254||0.8021||95.0|-0.44|0.56|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.56|-0.44|0.8021
71939952|NCT03384745|143400638|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the M1095 120mg normal load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71939953|NCT03384745|143400638|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 45 (88.2% \[76.1-95.6\], p\<0.0001) of 51 participants in the M1095 120mg augmented load treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71939954|NCT03384745|143400638|SUPERIORITY|A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates \>88% for study drug and \<=7% for placebo.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (\<=90; \>90kg).|At Week 12, none (0.0% \[95% CI 0.0-6.8\]) of the 52 participants in the placebo group had an IGA score of 0 or 1 versus 41 (77.4% \[63.8-87.7\], p\<0.0001) of 53 participants in the secukinumab 300mg treatment group. Odds ratio could not be calculated due to the placebo group containing no responders.|||<0.0001
71939955|NCT02739984|143400664|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-64.14|STANDARD_ERROR_OF_MEAN|2.05|<|0.0001|TWO_SIDED|95.0|-68.16|-60.12|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-60.12|-68.16|<0.0001
71939956|NCT02739984|143400665|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-53.14|STANDARD_ERROR_OF_MEAN|2.25|<|0.0001|TWO_SIDED|95.0|-57.56|-48.71|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.71|-57.56|<0.0001
71939957|NCT02739984|143400666|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-67.2|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|95.0|-72.1|-62.2|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-62.2|-72.1|<0.0001
71939958|NCT02739984|143400667|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-55.8|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-61.0|-50.5|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-50.5|-61.0|<0.0001
71939959|NCT02739984|143400668|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-56.56|STANDARD_ERROR_OF_MEAN|1.89|<|0.0001|TWO_SIDED|95.0|-60.28|-52.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-52.85|-60.28|<0.0001
71939960|NCT02739984|143400669|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-46.28|STANDARD_ERROR_OF_MEAN|2.1|<|0.0001|TWO_SIDED|95.0|-50.42|-42.15|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-42.15|-50.42|<0.0001
71693436|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.267||0.0249||95.0|0.08|1.13|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.13|0.08|0.0249
71693437|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3383||95.0|-0.26|0.75|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.75|-0.26|0.3383
71693438|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.06|STANDARD_ERROR_OF_MEAN|0.26||0.0001||95.0|0.55|1.57|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.57|0.55|0.0001
71693439|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.261||0.0133||95.0|0.14|1.17|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.17|0.14|0.0133
71693440|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.256||0.382||95.0|-0.28|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.73|-0.28|0.3820
71693441|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.75|STANDARD_ERROR_OF_MEAN|0.269||0.0053||95.0|0.23|1.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.28|0.23|0.0053
71693442|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.25|STANDARD_ERROR_OF_MEAN|0.256||0.3258||95.0|-0.25|0.76|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.76|-0.25|0.3258
71693443|NCT00676403|142901930|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.92|STANDARD_ERROR_OF_MEAN|0.26||0.0005||95.0|0.41|1.43|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.43|0.41|0.0005
71693444|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1429||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1429
71693445|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.3||0.0547||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0547
71693446|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.3||0.0095||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0095
71693447|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3676||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3676
71939961|NCT02739984|143400670|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-52.48|STANDARD_ERROR_OF_MEAN|1.85|<|0.0001|TWO_SIDED|95.0|-56.1|-48.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-48.85|-56.10|<0.0001
71939962|NCT02739984|143400671|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-42.12|STANDARD_ERROR_OF_MEAN|2.04|<|0.0001|TWO_SIDED|95.0|-46.13|-38.11|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.11|-46.13|<0.0001
71939963|NCT02739984|143400672|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-41.06|STANDARD_ERROR_OF_MEAN|1.44|<|0.0001|TWO_SIDED|95.0|-43.9|-38.22|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-38.22|-43.90|<0.0001
71939964|NCT02739984|143400673|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-33.74|STANDARD_ERROR_OF_MEAN|1.59|<|0.0001|TWO_SIDED|95.0|-36.87|-30.6|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-30.60|-36.87|<0.0001
71939965|NCT02739984|143400674|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|77.9|||<|0.0001|TWO_SIDED|95.0|70.0|83.5|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||83.5|70.0|<0.0001
71939966|NCT02739984|143400675|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|69.1|||<|0.0001|TWO_SIDED|95.0|60.4|75.7|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||75.7|60.4|<0.0001
71939967|NCT02739984|143400676|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|83.5|||<|0.0001|TWO_SIDED|95.0|77.7|87.4|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||87.4|77.7|<0.0001
71693448|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2959||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2959
71939968|NCT02739984|143400677|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|64.7|||<|0.0001|TWO_SIDED|95.0|57.7|70.3|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo|||70.3|57.7|<0.0001
71939969|NCT02739984|143400678|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-40.5|STANDARD_ERROR_OF_MEAN|3.87|<|0.0001|TWO_SIDED|95.0|-48.11|-32.9|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-32.90|-48.11|<0.0001
71939970|NCT02739984|143400679|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-32.56|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-39.58|-25.53|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-25.53|-39.58|<0.0001
71939971|NCT02739984|143400680|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-19.25|STANDARD_ERROR_OF_MEAN|3.41|<|0.0001|TWO_SIDED|95.0|-25.95|-12.54|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-12.54|-25.95|<0.0001
71939972|NCT02739984|143400681|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.7|STANDARD_ERROR_OF_MEAN|4.02|<|0.0001|TWO_SIDED|95.0|-21.6|-5.8|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-5.80|-21.60|<0.0001
71693449|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3435||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3435
71939973|NCT02739984|143400682|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|9.8|STANDARD_ERROR_OF_MEAN|1.45|<|0.0001|TWO_SIDED|95.0|6.95|12.64|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||12.64|6.95|<0.0001
71939974|NCT02739984|143400683|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|7.37|STANDARD_ERROR_OF_MEAN|1.62|<|0.0001|TWO_SIDED|95.0|4.19|10.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||10.56|4.19|<0.0001
71939975|NCT02739984|143400684|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-17.06|STANDARD_ERROR_OF_MEAN|2.98|<|0.0001|TWO_SIDED|95.0|-22.91|-11.21|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-11.21|-22.91|<0.0001
71939976|NCT02739984|143400685|SUPERIORITY|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.33|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|95.0|-20.09|-6.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo|||-6.56|-20.09|<0.0001
71939977|NCT03008460|143400686|NON_INFERIORITY|Non-inferiority would be demonstrated if the lower limit of the 95% confidence interval of the adjusted treatment difference was higher than -15%.|Adjusted treatment difference|-7.61||||0.0907|TWO_SIDED|95.0|-18.45|3.24||P-value for non-inferiority was estimated from the adjusted treatment difference.|Regression, Logistic|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a logistic regression model, including treatment and country as covariates.||3.24|-18.45|0.0907
71939978|NCT03008460|143400687|OTHER||Adjusted treatment difference|-0.18||||0.0428|TWO_SIDED|95.0|-0.36|-0.01|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||-0.01|-0.36|0.0428
71939979|NCT03008460|143400688|OTHER||Adjusted treatment difference|-0.07||||0.4676|TWO_SIDED|95.0|-0.25|0.12|||ANOVA|||"Left colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.12|-0.25|0.4676
71939980|NCT03008460|143400688|OTHER||Adjusted treatment difference|-0.09||||0.3076|TWO_SIDED|95.0|-0.25|0.08|||ANOVA|||"Transverse colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.08|-0.25|0.3076
71939981|NCT03008460|143400688|OTHER||Adjusted treatment difference|-0.24||||0.0155|TWO_SIDED|95.0|-0.44|-0.05|||ANOVA|||"Right colon:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||-0.05|-0.44|0.0155
71939982|NCT03008460|143400688|OTHER||Adjusted treatment difference|-0.36||||0.0975|TWO_SIDED|95.0|-0.79|0.07|||ANOVA|||"Global score:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||0.07|-0.79|0.0975
71939983|NCT03008460|143400689|OTHER||Adjusted treatment difference rate|1.3847||||0.2428|TWO_SIDED|95.0|0.8|2.4|||CMH chi-square|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) chi-square method (using the general association statistic), stratified on country.||2.4|0.8|0.2428
71939984|NCT03008460|143400690|OTHER||Adjusted treatment difference rate|24.0219|||<|0.0001|TWO_SIDED|95.0|12.6|45.9|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||45.9|12.6|<0.0001
71939985|NCT03008460|143400691|OTHER||Adjusted treatment difference rate|1.0022||||0.9257|TWO_SIDED|95.0|1.0|1.1|||CMH chi-square|||Analysis was performed using CMH chi-square method (using the general association statistic), stratified on country.||1.1|1.0|0.9257
71939986|NCT03008460|143400693|OTHER||Adjusted treatment difference|-0.93||||0.4459|TWO_SIDED|95.0|-3.32|1.47|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.47|-3.32|0.4459
71939987|NCT03008460|143400694|OTHER||Adjusted treatment difference|0.71|||<|0.0001|TWO_SIDED|95.0|0.4|1.03|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates.||1.03|0.40|<0.0001
71939988|NCT03008460|143400695|OTHER||Adjusted treatment difference rate|1.22||||0.3945|TWO_SIDED|95.0|-1.6|4.05|||ANOVA|||"Dose 1:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||4.05|-1.60|0.3945
71939989|NCT03008460|143400695|OTHER||Adjusted treatment difference rate|6.38||||0.0085|TWO_SIDED|95.0|1.65|11.12|||ANOVA|||"Dose 2:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||11.12|1.65|0.0085
71693450|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0895||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0895
71939990|NCT03008460|143400695|OTHER||Adjusted treatment difference rate|7.48||||0.0036|TWO_SIDED|95.0|2.46|12.5|||ANOVA|||"Global:~Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using a 2-way ANOVA, including treatment and country as covariates."||12.50|2.46|0.0036
71939991|NCT03008460|143400698|OTHER||Adjusted treatment difference|1.05||||0.0015|TWO_SIDED|95.0|0.41|1.69|||ANOVA|||Analysis of the treatment difference (Eziclen®/Izinova® minus Klean-Prep®) was performed using 2-way ANOVA, including treatment and country as covariates.||1.69|0.41|0.0015
71939992|NCT04947579|143400705|SUPERIORITY||Stratified difference|2.4||||0.829|TWO_SIDED|95.0|-18.2|22.7|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||22.7|-18.2|0.829
71939993|NCT04947579|143400705|SUPERIORITY||Stratified difference|7.3||||0.512|TWO_SIDED|95.0|-13.8|27.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||27.5|-13.8|0.512
71939994|NCT04947579|143400706|SUPERIORITY||Stratified difference|3.3||||0.725|TWO_SIDED|95.0|-14.9|21.0|||Cochran-Mantel-Haenszel||CC99677 60 mg - Placebo|||21.0|-14.9|0.725
71939995|NCT04947579|143400706|SUPERIORITY||Stratfied difference|12.2||||0.219|TWO_SIDED|95.0|-7.2|30.5|||Cochran-Mantel-Haenszel||CC99677 150 mg - Placebo|||30.5|-7.2|0.219
71939996|NCT04947579|143400707|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.167||0.299|TWO_SIDED|95.0|-0.5|0.16|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.16|-0.50|0.299
71939997|NCT04947579|143400707|SUPERIORITY||Difference in Adjusted Means|-0.12|STANDARD_ERROR_OF_MEAN|0.168||0.488|TWO_SIDED|95.0|-0.45|0.22|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.22|-0.45|0.488
71939998|NCT04947579|143400708|SUPERIORITY||Difference in Adjusted Means|0.01|STANDARD_ERROR_OF_MEAN|0.391||0.97|TWO_SIDED|95.0|-0.76|0.79|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.79|-0.76|0.970
71939999|NCT04947579|143400708|SUPERIORITY||Difference in Adjusted Means|-0.17|STANDARD_ERROR_OF_MEAN|0.393||0.668|TWO_SIDED|95.0|-0.95|0.61|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||0.61|-0.95|0.668
71940000|NCT04947579|143400709|SUPERIORITY||Difference in Adjusted Means|0.06|STANDARD_ERROR_OF_MEAN|0.416||0.89|TWO_SIDED|95.0|-0.77|0.88|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||0.88|-0.77|0.890
71940001|NCT04947579|143400709|SUPERIORITY||Difference in Adjusted Means|0.25|STANDARD_ERROR_OF_MEAN|0.417||0.545|TWO_SIDED|95.0|-0.57|1.08|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.08|-0.57|0.545
71940002|NCT04947579|143400710|SUPERIORITY||Difference in Adjusted Means|-0.28|STANDARD_ERROR_OF_MEAN|0.999||0.778|TWO_SIDED|95.0|-2.26|1.7|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||1.70|-2.26|0.778
71940003|NCT04947579|143400710|SUPERIORITY||Difference in Adjusted Means|-1.0|STANDARD_ERROR_OF_MEAN|1.022||0.33|TWO_SIDED|95.0|-3.02|1.03|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.03|-3.02|0.330
71940004|NCT04947579|143400711|SUPERIORITY||Difference in Adjusted Means|-0.82|STANDARD_ERROR_OF_MEAN|1.567||0.6|TWO_SIDED|95.0|-3.93|2.28|||Longitudinal data analysis model||CC99677 60 mg - Placebo|||2.28|-3.93|0.600
71940005|NCT04947579|143400711|SUPERIORITY||Difference in Adjusted Means|-1.31|STANDARD_ERROR_OF_MEAN|1.605||0.416|TWO_SIDED|95.0|-4.49|1.87|||Longitudinal data analysis model||CC99677 150 mg - Placebo|||1.87|-4.49|0.416
71940006|NCT04947579|143400712|SUPERIORITY||Adjusted Mean|-6.26|STANDARD_ERROR_OF_MEAN|10.741||||95.0|-27.31|14.79||||||||14.79|-27.31|
71940007|NCT04947579|143400712|SUPERIORITY||Adjusted Mean|-18.58|STANDARD_ERROR_OF_MEAN|9.181|||TWO_SIDED|95.0|-36.57|-0.58||||||||-0.58|-36.57|
71940008|NCT04947579|143400712|SUPERIORITY||Adjusted Mean|-12.16|STANDARD_ERROR_OF_MEAN|10.105|||TWO_SIDED|95.0|-31.96|7.65||||||||7.65|-31.96|
71940009|NCT01566409|143400718|NON_INFERIORITY_OR_EQUIVALENCE|The required sample size was based on a projected treatment success in the PEG group of 60%. With a power in excess of 80% and a critical level of significance of 0.05, 45 children were needed in each group to detect a 50% reduction in treatment effect in the placebo group, corresponding to 30% recovers without active maintenance treatment. Because of an expected drop-out rate of 25%, we aimed at including 115 children.||||||0.024|||||||Regression, Logistic|||||||0.024
71940010|NCT00097695|143400742|SUPERIORITY_OR_OTHER_LEGACY|||||||0.142||95.0|||||Wilcoxon version of the log-rank test|The Wilcoxon version of the log-rank test of SAS was used to calculate statistical significance between p- vs icatibant group and placebo group.||||||0.142
71693451|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.0844||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.0844
71940011|NCT00097695|143400743|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Wilcoxon version of the log-rank test|The median time to onset is calculated using Kaplan-Meier methodology. The Wilcoxon version of the log-rank test of SAS is used.||||||< 0.001
71940012|NCT00097695|143400744|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.079||95.0|||||Wilcoxon version of the log-rank test|The median time to almost complete symptom relief was calculated using Kaplan-Meier methodology.The Wilcoxon version of the log-rank test of SAS used.||||||= 0.079
71940013|NCT00770315|143400798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.2192|TWO_SIDED|95.0|-1.98|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-1.98|0.2192
71940014|NCT00770315|143400798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.58||||0.0113|TWO_SIDED|95.0|-2.8|-0.36|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.36|-2.80|0.0113
71940015|NCT00770315|143400798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04||||0.0015|TWO_SIDED|95.0|-3.3|-0.79|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.79|-3.30|0.0015
71940016|NCT00770315|143400799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.88||||0.0878|TWO_SIDED|95.0|-1.88|0.13|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.13|-1.88|0.0878
71940017|NCT00770315|143400799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.28||||0.0125|TWO_SIDED|95.0|-2.29|-0.28|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.28|-2.29|0.0125
71940018|NCT00770315|143400799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.92||||0.0003|TWO_SIDED|95.0|-2.95|-0.88|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.88|-2.95|0.0003
71940019|NCT00770315|143400800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.4781|TWO_SIDED|95.0|-0.96|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.45|-0.96|0.4781
71940020|NCT00770315|143400800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.1695|TWO_SIDED|95.0|-1.21|0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.21|-1.21|0.1695
71940021|NCT00770315|143400800|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.0118|TWO_SIDED|95.0|-1.67|-0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.21|-1.67|0.0118
71940022|NCT00770315|143400801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.2622|TWO_SIDED|95.0|-0.93|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-0.93|0.2622
71940023|NCT00770315|143400801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.1914|TWO_SIDED|95.0|-0.99|0.2|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.20|-0.99|0.1914
71693452|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0675||95.0|-1.1|0.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.1|0.0675
71693453|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.225||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.2250
71693454|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3728||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3728
71693455|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.2686||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.2686
71940024|NCT00770315|143400801|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.96||||0.0021|TWO_SIDED|95.0|-1.57|-0.35|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.35|-1.57|0.0021
71940025|NCT00770315|143400802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.19|TWO_SIDED|95.0|-1.26|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||0.25|-1.26|0.1900
71940026|NCT00770315|143400802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0053|TWO_SIDED|95.0|-1.84|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.84|0.0053
71940027|NCT00770315|143400802|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.1||||0.0058|TWO_SIDED|95.0|-1.89|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects|||-0.32|-1.89|0.0058
71940028|NCT02207231|143400807|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
71693456|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0753||95.0|-1.2|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.2|0.0753
71693457|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1335||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.0|0.1335
71940029|NCT02207231|143400808|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||||||<0.001
71940030|NCT02207231|143400809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
71940031|NCT02207231|143400809|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
71940032|NCT02207231|143400810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
71940033|NCT02207231|143400810|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
71940034|NCT02207231|143400811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24||||< 0.001
71940035|NCT02207231|143400811|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48||||< 0.001
71940036|NCT02207231|143400812|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).||||< 0.001
71940037|NCT02207231|143400813|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|19.3|||<|0.001|TWO_SIDED|95.0|12.9|25.7|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).||25.7|12.9|< 0.001
71693458|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.022||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0220
71693459|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.31||0.5754||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.5754
71693460|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.348||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3480
71693461|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.0|-1.2|0.0554
71693462|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4362||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4362
71693463|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3631||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.3631
71693464|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1152||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1152
71693465|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.3||0.4741||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.4|-0.8|0.4741
71693466|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|0.31||0.0091||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.2|-1.4|0.0091
71693467|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.3||0.1721||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-1.0|0.1721
71693468|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.31||0.0262||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-1.3|0.0262
71940038|NCT02207231|143400813|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71940039|NCT02207231|143400814|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10.0%|Difference in Percentage|24.1|||<|0.001|TWO_SIDED|95.0|17.0|31.0|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||31.0|17.0|< 0.001
71940040|NCT02207231|143400814|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71940041|NCT02207231|143400815|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|non-inferiority margin= 10%|Difference in percentage|18.0|||<|0.001|TWO_SIDED|95.0|12.4|23.8|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).||23.8|12.4|< 0.001
71940042|NCT02207231|143400815|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71940043|NCT02207231|143400816|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71940044|NCT02207231|143400817|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).||||< 0.001
71940045|NCT02207231|143400818|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).||||< 0.001
71940046|NCT02016300|143400852|OTHER|||||||0.162|||||||Regression, Linear|||Difference between baseline and month 6.||||0.162
71940047|NCT02016300|143400852|OTHER|||||||0.094|||||||Regression, Linear|||Difference between baseline and month 12.||||0.094
71940048|NCT02016300|143400852|OTHER|||||||0.043|||||||Regression, Linear|||Difference between baseline and month 24.||||0.043
71940049|NCT02016300|143400853|OTHER|||||||0.387|||||||Regression, Linear|||Difference between baseline and month 6.||||0.387
71940050|NCT02016300|143400853|OTHER|||||||0.34|||||||Regression, Linear|||Difference between baseline and month 12.||||0.340
71940051|NCT02016300|143400853|OTHER|||||||0.179|||||||Regression, Linear|||Difference between baseline and month 24.||||0.179
71940052|NCT02016300|143400854|OTHER|||||||0.729|||||||Regression, Linear|||Difference between baseline and month 6.||||0.729
71940053|NCT02016300|143400854|OTHER|||||||0.958|||||||Regression, Linear|||Difference between baseline and month 12.||||0.958
71940054|NCT02016300|143400854|OTHER|||||||0.634|||||||Regression, Linear|||Difference between baseline and month 24.||||0.634
71940055|NCT02016300|143400855|OTHER|||||||0.733|||||||Regression, Linear|||Difference between baseline and month 6.||||0.733
71940056|NCT02016300|143400855|OTHER|||||||0.666|||||||Regression, Linear|||Difference between baseline and month 12.||||0.666
71940057|NCT02016300|143400855|OTHER|||||||0.854|||||||Regression, Linear|||Difference between baseline and month 24.||||0.854
71940058|NCT02016300|143400856|OTHER|||||||0.774|||||||Regression, Linear|||Difference between baseline and month 12.||||0.774
71940059|NCT02016300|143400856|OTHER|||||||0.414|||||||Regression, Linear|||Difference between baseline and month 24.||||0.414
71940060|NCT02016300|143400857|OTHER|||||||0.064|||||||Regression, Linear|||Difference between baseline and month 12.||||0.064
71940061|NCT02016300|143400857|OTHER|||||||0.276|||||||Regression, Linear|||Difference between baseline and month 24.||||0.276
71940062|NCT02016300|143400858|OTHER|||||||0.02|||||||Regression, Linear|||Difference between baseline and month 12.||||0.020
71940063|NCT02016300|143400858|OTHER|||||||0.091|||||||Regression, Linear|||Difference between baseline and month 24.||||0.091
71940064|NCT03702621|143400898|OTHER|P values are from mixed model least squares (LS) means differences with Sidak adjustment for multiple comparisons.||||||0.54|||||||Mixed Models Analysis|Sidak adjustment||||||0.54
71940065|NCT03702621|143400899|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.59|||||||Mixed Models Analysis|||||||0.59
71940066|NCT03702621|143400900|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.98||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.98
71940067|NCT03702621|143400901|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.94||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||0.94
71940068|NCT03702621|143400902|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||0.86|||||||Mixed Models Analysis|Sidak adjustment||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||0.86
71940069|NCT03702621|143400903|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons||||||1||||||P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons|Mixed Models Analysis|Sidak adjustment||||||1.0
71940070|NCT03702621|143400904|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
71940071|NCT03702621|143400905|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.99|||||||Mixed Models Analysis|||||||0.99
71940072|NCT03702621|143400906|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.72|||||||Mixed Models Analysis|||||||0.72
71940073|NCT03702621|143400907|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.29|||||||Mixed Models Analysis|||||||0.29
71940074|NCT03702621|143400908|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.46|||||||Mixed Models Analysis|||||||0.46
71940075|NCT03702621|143400909|OTHER|P values are from mixed model LS means differences with Sidak adjustment for multiple comparisons.||||||0.77|||||||Mixed Models Analysis|||||||0.77
71940076|NCT02606500|143400943|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
71940077|NCT02606500|143400944|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.5|||||||Regression, Logistic|||||||0.5
71940078|NCT02606500|143400945|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.3|||||||Regression, Logistic|||||||0.3
71940079|NCT02606500|143400946|NON_INFERIORITY|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic|||||||0.9
71940080|NCT02606500|143400947|NON_INFERIORITY|We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.||||||0.4|||||||Regression, Logistic|||||||0.4
71693469|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.31||0.9505||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9505
71940081|NCT00810368|143400967|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|||||2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.|t-test, 2 sided|Paired t-test||Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).||||0.30
71940082|NCT00810368|143400967|SUPERIORITY_OR_OTHER|||||||0.4|TWO_SIDED||||||t-test, 2 sided|||||||0.40
71940083|NCT00810368|143400968|SUPERIORITY_OR_OTHER|||||||0.018|TWO_SIDED|||||Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.|Fisher Exact|2 by 2 Fisher's Exact Test||||||0.018
71940084|NCT00810368|143400969|SUPERIORITY_OR_OTHER|||||||0.0018|TWO_SIDED||||||t-test, 2 sided|||||||0.0018
71940085|NCT00810368|143400969|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||t-test, 2 sided|||||||0.60
71940086|NCT00810368|143400971|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71940087|NCT00810368|143400972|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.5
71940088|NCT00810368|143400973|SUPERIORITY_OR_OTHER|||||||0.5|TWO_SIDED||||||t-test, 2 sided|||||||0.50
71940089|NCT00442936|143400992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.26|||<|0.001|TWO_SIDED|95.0|1.4|3.66|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.66|1.40|<0.001
71940090|NCT00442936|143400992|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.81|||<|0.001|TWO_SIDED|95.0|2.42|6.0|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||6.00|2.42|<0.001
71940091|NCT00442936|143400993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.82|||<|0.001|TWO_SIDED|95.0|2.02|3.95|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.95|2.02|<0.001
71940092|NCT00442936|143400993|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.44|||<|0.001|TWO_SIDED|95.0|2.47|4.79|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.79|2.47|<0.001
71940093|NCT00442936|143400994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.14|||<|0.001|TWO_SIDED|95.0|1.54|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.54|<0.001
71940094|NCT00442936|143400994|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.89|3.61|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.61|1.89|<0.001
71940095|NCT00442936|143400995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.05|||<|0.001|TWO_SIDED|95.0|1.49|2.82|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.82|1.49|<0.001
71940096|NCT00442936|143400995|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.37|||<|0.001|TWO_SIDED|95.0|1.73|3.25|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||3.25|1.73|<0.001
71940097|NCT00442936|143400996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.73|||<|0.001|TWO_SIDED|95.0|1.25|2.39|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.39|1.25|<0.001
71940098|NCT00442936|143400996|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.006|TWO_SIDED|95.0|1.13|2.13|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.13|1.13|0.006
71940099|NCT00442936|143400997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8||||0.002|TWO_SIDED|95.0|1.47|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|1.47|0.002
71940100|NCT00442936|143400997|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.75|||<|0.001|TWO_SIDED|95.0|3.15|10.51|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||10.51|3.15|<0.001
71940101|NCT00442936|143400998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.026|TWO_SIDED|95.0|1.07|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||2.97|1.07|0.026
71940102|NCT00442936|143400998|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.34|||<|0.001|TWO_SIDED|95.0|2.08|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||5.35|2.08|<0.001
71940103|NCT00442936|143400999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.25||||0.021|TWO_SIDED|95.0|1.13|4.47|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||4.47|1.13|0.021
71693470|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6877||95.0|-0.7|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-0.7|0.6877
71940104|NCT00442936|143400999|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.21|||<|0.001|TWO_SIDED|95.0|2.78|9.76|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio \>1 is in favor of the first treatment group of the corresponding pairwise comparison.|||9.76|2.78|<0.001
71940105|NCT03365375|143401024|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.82|TWO_SIDED||||||t-test, 2 sided|||||||0.82
71940106|NCT03879239|143401036|SUPERIORITY|||||||0.0011||||||Responder Rate on Weekly CSBM1 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0011
71940107|NCT03879239|143401036|SUPERIORITY|||||||0.0085||||||Responder Rate on Weekly CSBM2 in the ITT (Intention to Treat) analysis set. (For details, refer to the primary outcome description).|Chi-squared|||||||0.0085
71940108|NCT00266409|143401042|SUPERIORITY_OR_OTHER|||||||0.1143||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.1143
71693471|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.31||0.1271||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-1.1|0.1271
71940109|NCT00266409|143401042|SUPERIORITY_OR_OTHER|||||||0.4544||95.0|||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.4544
71940110|NCT00266409|143401043|SUPERIORITY_OR_OTHER|||||||0.0173||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0173
71940111|NCT00266409|143401043|SUPERIORITY_OR_OTHER|||||||0.0516||95.0|||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate||||0.0516
71940112|NCT00266409|143401044|SUPERIORITY_OR_OTHER|||||||0.0361||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0361
71940113|NCT00266409|143401044|SUPERIORITY_OR_OTHER|||||||0.0366||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.0366
71940114|NCT00266409|143401045|SUPERIORITY_OR_OTHER|||||||0.739||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7390
71940115|NCT00266409|143401045|SUPERIORITY_OR_OTHER|||||||0.6735||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.6735
71940116|NCT00266409|143401046|SUPERIORITY_OR_OTHER|||||||0.4261||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4261
71940117|NCT00266409|143401046|SUPERIORITY_OR_OTHER|||||||0.0231||95.0||||P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate|ANCOVA|||||||0.0231
71940118|NCT00266409|143401047|SUPERIORITY_OR_OTHER|||||||0.182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate|ANCOVA|||||||0.1820
71940119|NCT00266409|143401047|SUPERIORITY_OR_OTHER|||||||0.2187||95.0||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate|ANCOVA|||||||0.2187
71940120|NCT00266409|143401048|SUPERIORITY_OR_OTHER|||||||0.1456||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1456
71940121|NCT00266409|143401048|SUPERIORITY_OR_OTHER|||||||0.3618||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3618
71940122|NCT00266409|143401049|SUPERIORITY_OR_OTHER|||||||0.3535||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3535
71940123|NCT00266409|143401049|SUPERIORITY_OR_OTHER|||||||0.566||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.5660
71940124|NCT00266409|143401050|SUPERIORITY_OR_OTHER|||||||0.3414||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.3414
71940125|NCT00266409|143401050|SUPERIORITY_OR_OTHER|||||||0.7344||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.7344
71940126|NCT00266409|143401051|SUPERIORITY_OR_OTHER|||||||0.1197||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.1197
71940127|NCT00266409|143401051|SUPERIORITY_OR_OTHER|||||||0.4416||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA|||||||0.4416
71940128|NCT00266409|143401052|SUPERIORITY_OR_OTHER|||||||0.035||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0350
71940129|NCT00266409|143401052|SUPERIORITY_OR_OTHER|||||||0.4205||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.4205
71940130|NCT00266409|143401053|SUPERIORITY_OR_OTHER|||||||0.2645||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.2645
71940131|NCT00266409|143401053|SUPERIORITY_OR_OTHER|||||||0.5369||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5369
71940132|NCT00266409|143401054|SUPERIORITY_OR_OTHER|||||||0.9988||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9988
71940133|NCT00266409|143401054|SUPERIORITY_OR_OTHER|||||||0.7729||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7729
71940134|NCT00266409|143401055|SUPERIORITY_OR_OTHER|||||||0.7338||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7338
71940135|NCT00266409|143401055|SUPERIORITY_OR_OTHER|||||||0.0897||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.0897
71940136|NCT00266409|143401056|SUPERIORITY_OR_OTHER|||||||0.6501||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6501
71940137|NCT00266409|143401056|SUPERIORITY_OR_OTHER|||||||0.8196||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8196
71940138|NCT00266409|143401057|SUPERIORITY_OR_OTHER|||||||0.6404||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6404
71940139|NCT00266409|143401057|SUPERIORITY_OR_OTHER|||||||0.8263||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8263
71940140|NCT00266409|143401058|SUPERIORITY_OR_OTHER|||||||0.6946||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.6946
71940141|NCT00266409|143401058|SUPERIORITY_OR_OTHER|||||||0.9629||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9629
71940142|NCT00266409|143401059|SUPERIORITY_OR_OTHER|||||||0.8617||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.8617
71693472|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.3||0.9136||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.6|-0.6|0.9136
71693473|NCT00676403|142901931|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4072||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-0.9|0.4072
71693474|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|10.68||0.186||95.0|-35.2|6.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-35.2|0.1860
71693475|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|10.54||0.653||95.0|-25.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-25.5|0.6530
71693476|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|10.79||0.6263||95.0|-26.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.0|-26.5|0.6263
71693477|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.5|STANDARD_ERROR_OF_MEAN|10.63||0.4266||95.0|-29.4|12.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-29.4|0.4266
71693478|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|10.54||0.4023||95.0|-29.6|11.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-29.6|0.4023
71693479|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.6|STANDARD_ERROR_OF_MEAN|10.77||0.1041||95.0|-38.8|3.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.6|-38.8|0.1041
71693480|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|10.6||0.5084||95.0|-27.9|13.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.8|-27.9|0.5084
71940143|NCT00266409|143401059|SUPERIORITY_OR_OTHER|||||||0.7555||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.7555
71693481|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.5|STANDARD_ERROR_OF_MEAN|11.1||0.262||95.0|-34.3|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-34.3|0.2620
71940144|NCT00266409|143401060|SUPERIORITY_OR_OTHER|||||||0.5836||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.5836
71940145|NCT00266409|143401060|SUPERIORITY_OR_OTHER|||||||0.9096||95.0|||||Chi-squared|||Analysis refers to test of differences in response rates.||||0.9096
71761120|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|0.5||||0.6533|TWO_SIDED|95.0|-1.67|2.66||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Diarrhoea|||2.66|-1.67|0.6533
71940146|NCT00266409|143401061|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0002
71940147|NCT00266409|143401061|SUPERIORITY_OR_OTHER|||||||0.0006||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0006
71940148|NCT00266409|143401062|SUPERIORITY_OR_OTHER|||||||0.0255||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0255
71940149|NCT00266409|143401062|SUPERIORITY_OR_OTHER|||||||0.0065||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0065
71940150|NCT00266409|143401063|SUPERIORITY_OR_OTHER|||||||0.037||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0370
71940151|NCT00266409|143401063|SUPERIORITY_OR_OTHER|||||||0.9569||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.9569
71940152|NCT00266409|143401064|SUPERIORITY_OR_OTHER|||||||0.0978||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0978
71940153|NCT00266409|143401064|SUPERIORITY_OR_OTHER|||||||0.7096||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.7096
71940154|NCT00266409|143401065|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0001
71940155|NCT00266409|143401065|SUPERIORITY_OR_OTHER|||||||0.0003||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0003
71940156|NCT00266409|143401066|SUPERIORITY_OR_OTHER|||||||0.0025||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0025
71940157|NCT00266409|143401066|SUPERIORITY_OR_OTHER|||||||0.0101||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0101
71940158|NCT00266409|143401067|SUPERIORITY_OR_OTHER|||||||0.0095||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0095
71940159|NCT00266409|143401067|SUPERIORITY_OR_OTHER|||||||0.039||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0390
71940160|NCT00266409|143401068|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0160
71940161|NCT00266409|143401068|SUPERIORITY_OR_OTHER|||||||0.1024||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1024
71761121|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-2.32||||0.0963|TWO_SIDED|95.0|-5.06|0.42||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Dyspnoea|||0.42|-5.06|0.0963
71940162|NCT00266409|143401069|SUPERIORITY_OR_OTHER|||||||0.0761||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0761
71940163|NCT00266409|143401069|SUPERIORITY_OR_OTHER|||||||0.0376||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0376
71940164|NCT00266409|143401070|SUPERIORITY_OR_OTHER|||||||0.1196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1196
71940165|NCT00266409|143401070|SUPERIORITY_OR_OTHER|||||||0.0029||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0029
71940166|NCT00266409|143401071|SUPERIORITY_OR_OTHER|||||||0.6323||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.6323
71940167|NCT00266409|143401071|SUPERIORITY_OR_OTHER|||||||0.5533||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.5533
71940168|NCT00266409|143401072|SUPERIORITY_OR_OTHER|||||||0.1705||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.1705
71940169|NCT00266409|143401072|SUPERIORITY_OR_OTHER|||||||0.3196||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.3196
71940170|NCT00266409|143401073|SUPERIORITY_OR_OTHER|||||||0.0419||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.0419
71940171|NCT00266409|143401073|SUPERIORITY_OR_OTHER|||||||0.2541||95.0|||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.||||0.2541
71940172|NCT00266409|143401074|SUPERIORITY_OR_OTHER|||||||0.0677||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0677
71940173|NCT00266409|143401074|SUPERIORITY_OR_OTHER|||||||0.0273||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0273
71940174|NCT00266409|143401075|SUPERIORITY_OR_OTHER|||||||0.5153||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5153
71940175|NCT00266409|143401075|SUPERIORITY_OR_OTHER|||||||0.0122||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0122
71940176|NCT00266409|143401076|SUPERIORITY_OR_OTHER|||||||0.4648||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4648
71940177|NCT00266409|143401076|SUPERIORITY_OR_OTHER|||||||0.5502||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5502
71940178|NCT00266409|143401077|SUPERIORITY_OR_OTHER|||||||0.9093||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.9093
71761122|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|3.89||||0.0037|TWO_SIDED|95.0|1.27|6.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Emotional Functioning|||6.51|1.27|0.0037
71940179|NCT00266409|143401077|SUPERIORITY_OR_OTHER|||||||0.1354||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1354
71940180|NCT00266409|143401078|SUPERIORITY_OR_OTHER|||||||0.7434||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.7434
71940181|NCT00266409|143401078|SUPERIORITY_OR_OTHER|||||||0.1148||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.1148
71940182|NCT00266409|143401079|SUPERIORITY_OR_OTHER|||||||0.9346||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate|ANCOVA|||||||0.9346
71940183|NCT00266409|143401079|SUPERIORITY_OR_OTHER|||||||0.2709||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2709
71940184|NCT00266409|143401080|SUPERIORITY_OR_OTHER|||||||0.3827||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3827
71940185|NCT00266409|143401080|SUPERIORITY_OR_OTHER|||||||0.2513||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.2513
71940186|NCT00266409|143401081|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.3930
71940187|NCT00266409|143401081|SUPERIORITY_OR_OTHER|||||||0.5461||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.5461
71940188|NCT00266409|143401082|SUPERIORITY_OR_OTHER|||||||0.0722||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.0722
71940189|NCT00266409|143401082|SUPERIORITY_OR_OTHER|||||||0.4639||95.0||||P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA|||||||0.4639
71940190|NCT00266409|143401083|SUPERIORITY_OR_OTHER|||||||0.0075||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0075
71940191|NCT00266409|143401083|SUPERIORITY_OR_OTHER|||||||0.1641||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate|ANCOVA|||||||0.1641
71940192|NCT00266409|143401084|SUPERIORITY_OR_OTHER|||||||0.0932||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0932
71940193|NCT00266409|143401084|SUPERIORITY_OR_OTHER|||||||0.0852||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0852
71940194|NCT00266409|143401085|SUPERIORITY_OR_OTHER|||||||0.7896||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.7896
71940195|NCT00266409|143401085|SUPERIORITY_OR_OTHER|||||||0.9651||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9651
71940196|NCT00266409|143401086|SUPERIORITY_OR_OTHER|||||||0.828||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8280
71940197|NCT00266409|143401086|SUPERIORITY_OR_OTHER|||||||0.0936||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.0936
71940198|NCT00266409|143401087|SUPERIORITY_OR_OTHER|||||||0.3539||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3539
71940199|NCT00266409|143401087|SUPERIORITY_OR_OTHER|||||||0.4672||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.4672
71940200|NCT00266409|143401088|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.2550
71940201|NCT00266409|143401088|SUPERIORITY_OR_OTHER|||||||0.3125||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3125
71940202|NCT00266409|143401089|SUPERIORITY_OR_OTHER|||||||0.3174||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3174
71940203|NCT00266409|143401089|SUPERIORITY_OR_OTHER|||||||0.9427||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.9427
71940204|NCT00266409|143401090|SUPERIORITY_OR_OTHER|||||||0.3252||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.3252
71940205|NCT00266409|143401090|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.6090
71940206|NCT00266409|143401091|SUPERIORITY_OR_OTHER|||||||0.1247||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1247
71761123|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-4.63||||0.0013|TWO_SIDED|95.0|-7.45|-1.82||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue|||-1.82|-7.45|0.0013
71940207|NCT00266409|143401091|SUPERIORITY_OR_OTHER|||||||0.843||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.8430
71940208|NCT00266409|143401092|SUPERIORITY_OR_OTHER|||||||0.1031||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1031
71940209|NCT00266409|143401092|SUPERIORITY_OR_OTHER|||||||0.0543||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0543
71940210|NCT00266409|143401093|SUPERIORITY_OR_OTHER|||||||0.0508||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0508
71940211|NCT00266409|143401093|SUPERIORITY_OR_OTHER|||||||0.0871||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0871
71940212|NCT00266409|143401094|SUPERIORITY_OR_OTHER|||||||0.8318||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.8318
71940213|NCT00266409|143401094|SUPERIORITY_OR_OTHER|||||||0.5375||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.5375
71940214|NCT00266409|143401095|SUPERIORITY_OR_OTHER|||||||0.2186||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2186
71940215|NCT00266409|143401095|SUPERIORITY_OR_OTHER|||||||0.0422||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.0422
71940216|NCT00266409|143401096|SUPERIORITY_OR_OTHER|||||||0.1164||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1164
71940217|NCT00266409|143401096|SUPERIORITY_OR_OTHER|||||||0.1935||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1935
71940218|NCT00266409|143401097|SUPERIORITY_OR_OTHER|||||||0.1244||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.1244
71940219|NCT00266409|143401097|SUPERIORITY_OR_OTHER|||||||0.6182||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.6182
71940220|NCT00266409|143401098|SUPERIORITY_OR_OTHER|||||||0.4589||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4589
71940221|NCT00266409|143401098|SUPERIORITY_OR_OTHER|||||||0.393||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.3930
71940222|NCT00266409|143401099|SUPERIORITY_OR_OTHER|||||||0.445||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.4450
71940223|NCT00266409|143401099|SUPERIORITY_OR_OTHER|||||||0.2924||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2924
71940224|NCT00266409|143401100|SUPERIORITY_OR_OTHER|||||||0.2184||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA|||||||0.2184
71940225|NCT00266409|143401100|SUPERIORITY_OR_OTHER|||||||0.1281||95.0||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA|||||||0.1281
71693482|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.3|STANDARD_ERROR_OF_MEAN|10.7||0.3347||95.0|-31.4|10.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-31.4|0.3347
71693483|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.8|STANDARD_ERROR_OF_MEAN|10.61||0.1142||95.0|-37.7|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-37.7|0.1142
71693484|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.1|STANDARD_ERROR_OF_MEAN|11.06||0.1237||95.0|-38.8|4.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-38.8|0.1237
71693485|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.3|STANDARD_ERROR_OF_MEAN|10.67||0.8302||95.0|-18.7|23.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-18.7|0.8302
71693486|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|11.22||0.3039||95.0|-33.6|10.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.5|-33.6|0.3039
71693487|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.0|STANDARD_ERROR_OF_MEAN|10.77||0.4595||95.0|-29.2|13.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.2|-29.2|0.4595
71940226|NCT00266409|143401101|SUPERIORITY_OR_OTHER|||||||0.6602||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.6602
71940227|NCT00266409|143401102|SUPERIORITY_OR_OTHER|||||||0.5544||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5544
71940228|NCT00266409|143401103|SUPERIORITY_OR_OTHER|||||||0.9269||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9269
71940229|NCT00266409|143401104|SUPERIORITY_OR_OTHER|||||||0.5271||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5271
71940230|NCT00266409|143401105|SUPERIORITY_OR_OTHER|||||||0.1447||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.1447
71940231|NCT00266409|143401106|SUPERIORITY_OR_OTHER|||||||0.9375||95.0||||P-value from a Chi-squared test|Chi-squared|||||||0.9375
71940232|NCT00266409|143401107|SUPERIORITY_OR_OTHER|||||||0.9883||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.9883
71940233|NCT00266409|143401108|SUPERIORITY_OR_OTHER|||||||0.3093||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.3093
71940234|NCT00266409|143401109|SUPERIORITY_OR_OTHER|||||||0.5824||95.0|||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack||||0.5824
71940235|NCT00266409|143401110|SUPERIORITY_OR_OTHER|||||||0.044||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.044
71940236|NCT00266409|143401110|SUPERIORITY_OR_OTHER|||||||0.6587||95.0|||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.||||0.6587
71940237|NCT00635154|143401111|SUPERIORITY_OR_OTHER||Proportion of confirmed responses (%)|1.8||||||95.0|0.5|10.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.||10|0.5|
71940238|NCT01399736|143401118|SUPERIORITY||Hazard Ratio (HR)|0.35|||<|0.001|TWO_SIDED|95.0|0.22|0.55|||Chi-squared|||||0.55|0.22|<0.001
71940239|NCT01399736|143401119|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.7|TWO_SIDED|95.0|0.25|2.56|||Chi-squared|||||2.56|0.25|0.70
71940240|NCT01399736|143401120|SUPERIORITY||Hazard Ratio (HR)|1.0||||1|TWO_SIDED|95.0|0.25|4.01|||Chi-squared|||||4.01|0.25|1.00
71940241|NCT01399736|143401121|SUPERIORITY||Hazard Ratio (HR)|0.5||||0.1|TWO_SIDED|95.0|0.22|1.13|||Chi-squared|||||1.13|0.22|0.10
71940242|NCT01399736|143401122|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.29|TWO_SIDED|95.0|0.22|1.59|||Chi-squared|||||1.59|0.22|0.29
71940243|NCT01399736|143401123|SUPERIORITY||Hazard Ratio (HR)|0.37|||<|0.001|TWO_SIDED|95.0|0.24|0.57|||Chi-squared|||||0.57|0.24|<0.001
71940244|NCT01399736|143401124|SUPERIORITY||Hazard Ratio (HR)|1.2||||0.8|TWO_SIDED|95.0|0.29|5.02|||Chi-squared|||||5.02|0.29|0.80
71940245|NCT00995553|143401165|SUPERIORITY_OR_OTHER|||||||0.06|TWO_SIDED||||||ANOVA|||MATRICS Working Memory Index||||.06
71940246|NCT00995553|143401165|SUPERIORITY_OR_OTHER|||||||0.09|TWO_SIDED||||||ANOVA|||MATRICS Attention Index||||.09
71940247|NCT00995553|143401166|SUPERIORITY_OR_OTHER|||||||0.73|||||||ANOVA|||||||.73
71940248|NCT01089647|143401167|OTHER||||||=|0.946|||||||ANOVA|||Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.||||=0.946
71940249|NCT04799158|143401230|SUPERIORITY||Percentage difference|28.7|||<|0.0001|TWO_SIDED|95.0|21.84|35.55|||Fisher Exact|||||35.55|21.84|<0.0001
71940250|NCT04799158|143401230|SUPERIORITY||Percentage difference|33.3|||<|0.0001|TWO_SIDED|95.0|26.28|40.23|||Fisher Exact|||||40.23|26.28|<0.0001
71940251|NCT04799158|143401230|SUPERIORITY||Percentage difference|42.7|||<|0.0001|TWO_SIDED|95.0|35.92|49.42|||Fisher Exact|||||49.42|35.92|<0.0001
71940252|NCT04799158|143401231|SUPERIORITY||Percentage difference|30.3|||<|0.0001|TWO_SIDED|95.0|23.41|37.09|||Fisher Exact|||||37.09|23.41|<0.0001
71940253|NCT04799158|143401231|SUPERIORITY||Percentage difference|23.9|||<|0.0001|TWO_SIDED|95.0|16.67|31.05|||Fisher Exact|||||31.05|16.67|<0.0001
71940254|NCT04799158|143401231|SUPERIORITY||Percentage difference|37.7|||<|0.0001|TWO_SIDED|95.0|31.0|44.35|||Fisher Exact|||||44.35|31.00|<0.0001
71940255|NCT04799158|143401232|SUPERIORITY|||||||0.1771|||||||Wilcoxon rank-sum test|||||||0.1771
71940256|NCT04799158|143401232|SUPERIORITY|||||||0.1551|||||||Wilcoxon rank-sum test|||||||0.1551
71940257|NCT04799158|143401232|SUPERIORITY|||||||0.0094|||||||Wilcoxon rank-sum test|||||||0.0094
71940258|NCT04799158|143401233|SUPERIORITY|||||||0.3395|||||||Wilcoxon rank-sum test|||||||0.3395
71940259|NCT04799158|143401233|SUPERIORITY|||||||0.4882|||||||Wilcoxon rank-sum test|||||||0.4882
71940260|NCT04799158|143401233|SUPERIORITY|||||||0.0722|||||||Wilcoxon rank-sum test|||||||0.0722
71940261|NCT04799158|143401234|SUPERIORITY||Percentage difference|-3.9||||0.83|TWO_SIDED|95.0|-24.41|16.52|||Fisher Exact|||||16.52|-24.41|0.8300
71761124|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-1.76||||0.2902|TWO_SIDED|95.0|-5.02|1.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Financial Difficulties|||1.51|-5.02|0.2902
71940262|NCT04799158|143401234|SUPERIORITY||Percentage difference|1.4|||>|0.9999|TWO_SIDED|95.0|-19.28|22.16|||Fisher Exact|||||22.16|-19.28|>0.9999
71940263|NCT04799158|143401234|SUPERIORITY||Percentage difference|2.3|||>|0.9999|TWO_SIDED|95.0|-18.22|22.88|||Fisher Exact|||||22.88|-18.22|>0.9999
71940264|NCT04799158|143401235|SUPERIORITY|||||||0.4684|||||||Wilcoxon rank-sum test|||||||0.4684
71940265|NCT04799158|143401235|SUPERIORITY|||||||0.656|||||||Wilcoxon rank-sum test|||||||0.6560
71940266|NCT04799158|143401235|SUPERIORITY|||||||0.6324|||||||Wilcoxon rank-sum test|||||||0.6324
71940267|NCT04799158|143401236|SUPERIORITY|||||||0.9896|||||||Wilcoxon rank-sum test|||||||0.9896
71940268|NCT04799158|143401236|SUPERIORITY|||||||0.6916|||||||Wilcoxon rank-sum test|||||||0.6916
71940269|NCT04799158|143401236|SUPERIORITY|||||||0.9316|||||||Wilcoxon rank-sum test|||||||0.9316
71940270|NCT03587207|143401247|OTHER|rMenBOMV+ACWY\_S is to be declared statistically inferior if the 2-sided 80% CIs of the between group ratio of the GMT with rMenBOMV+ACWY\_D as control is lower than 1 at 1 month after last vaccination. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|0.96|||||TWO_SIDED|80.0|0.83|1.1|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after last vaccination.||1.10|0.83|
71940271|NCT03587207|143401248|OTHER|M14459 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.84|1.2|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.20|0.84|
71940272|NCT03587207|143401248|OTHER|96217 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|1.05||||||80.0|0.88|1.26|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.26|0.88|
71940273|NCT03587207|143401248|OTHER|NZ98/254 strain-Between group ratios for comparison of rMenBOMV+ACWY\_S and rMenBOMV+ACWY\_D groups|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.95|0.64|
71940274|NCT03587207|143401248|OTHER|M07-0241084 strain- Between group ratios for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.66|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.96|0.66|
71940275|NCT03587207|143401248|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.92|||||TWO_SIDED|80.0|0.74|1.14|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after last vaccination.||1.14|0.74|
71940276|NCT03587207|143401248|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|1.0|||||TWO_SIDED|80.0|0.78|1.27|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after last vaccination.||1.27|0.78|
71940277|NCT03587207|143401248|OTHER|Serogroup W- Between group ratios for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.97|||||TWO_SIDED|80.0|0.79|1.18|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after last vaccination.||1.18|0.79|
71940278|NCT03587207|143401248|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.69|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.19|0.69|
71940279|NCT03587207|143401248|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.86|
71940280|NCT03587207|143401248|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.66|0.95|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.||0.95|0.66|
71940281|NCT03587207|143401248|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.79|||||TWO_SIDED|80.0|0.65|0.97|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.97|0.65|
71940282|NCT03587207|143401248|NON_INFERIORITY|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.6|0.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.88|0.60|
71940283|NCT03587207|143401248|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.56|||||TWO_SIDED|80.0|0.45|0.69|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.||0.69|0.45|
71940284|NCT03587207|143401248|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.19|||||TWO_SIDED|80.0|0.94|1.52|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after last vaccination.||1.52|0.94|
71940285|NCT03587207|143401248|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.06|||||TWO_SIDED|80.0|0.87|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after last vaccination.||1.29|0.87|
71940286|NCT03587207|143401248|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.18|||||TWO_SIDED|80.0|0.9|1.55|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after last vaccination.||1.55|0.90|
71940287|NCT03587207|143401248|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.||1.22|0.85|
71940288|NCT03587207|143401248|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.9|||||TWO_SIDED|80.0|0.75|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.09|0.75|
71940289|NCT03587207|143401248|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.64|0.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.96|0.64|
71940290|NCT03587207|143401248|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.58|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.86|0.58|
71940291|NCT03587207|143401248|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.6|||||TWO_SIDED|80.0|2.9|4.47|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.47|2.90|
71940292|NCT03587207|143401248|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|4.18|||||TWO_SIDED|80.0|3.28|5.31|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.31|3.28|
71761125|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-1.22||||0.0606|TWO_SIDED|95.0|-2.49|0.05||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Nausea and Vomiting|||0.05|-2.49|0.0606
71940293|NCT03587207|143401248|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|3.07|||||TWO_SIDED|80.0|2.52|3.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.73|2.52|
71940294|NCT03587207|143401248|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and MenACWY group.|Geometric mean ratio|2.01|||||TWO_SIDED|80.0|1.53|2.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.65|1.53|
71940295|NCT03587207|143401248|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.85|1.22|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.22|0.85|
71940296|NCT03587207|143401248|OTHER|96217 strain- Between group ratios for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.71|1.04|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||1.04|0.71|
71940297|NCT03587207|143401248|OTHER|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.82|1.24|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||1.24|0.82|
71940298|NCT03587207|143401248|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_D group and rMenBOMV group.|Geometric mean ratio|0.89|||||TWO_SIDED|80.0|0.73|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||1.09|0.73|
71940299|NCT03587207|143401248|OTHER|Serogroup A-Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.92|||||TWO_SIDED|80.0|3.15|4.88|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||4.88|3.15|
71940300|NCT03587207|143401248|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|4.19|||||TWO_SIDED|80.0|3.3|5.34|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||5.34|3.30|
71940301|NCT03587207|143401248|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|3.17|||||TWO_SIDED|80.0|2.6|3.87|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.87|2.60|
71940302|NCT03587207|143401248|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_D group and MenACWY group.|Geometric mean ratio|2.22|||||TWO_SIDED|80.0|1.68|2.92|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||2.92|1.68|
71940303|NCT03587207|143401248|OTHER|M14459- Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.87|1.25|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.||1.25|0.87|
71940304|NCT03587207|143401248|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV group.|Geometric mean ratio|0.71|||||TWO_SIDED|80.0|0.59|0.86|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.||0.86|0.59|
71940305|NCT03587207|143401248|OTHER|NZ98/254 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.62|||||TWO_SIDED|80.0|0.5|0.76|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.||0.76|0.50|
71940306|NCT03587207|143401248|OTHER|M07-0241084 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.52|||||TWO_SIDED|80.0|0.42|0.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.||0.63|0.42|
71940307|NCT03587207|143401248|OTHER|Serogroup A- Between group ratios for comparison between MenABCWY group and MenACWY group|Geometric mean ratio|2.02|||||TWO_SIDED|80.0|1.62|2.51|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.||2.51|1.62|
71940308|NCT03587207|143401248|OTHER|Serogroup C- Between group ratios for comparison of MenABCWY group and MenACWY group|Odds Ratio (OR)|4.99|||||TWO_SIDED|80.0|3.92|6.35|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.||6.35|3.92|
71940309|NCT03587207|143401248|OTHER|Serogroup W- Between group ratios for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|3.25|||||TWO_SIDED|80.0|2.66|3.96|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.||3.96|2.66|
71940310|NCT03587207|143401248|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|2.38|||||TWO_SIDED|80.0|1.81|3.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.||3.12|1.81|
71940311|NCT03587207|143401252|OTHER|Between group ratio is calculated as GMT for rMenBOMV+ACWY\_S Group over GMT for rMenBOMV+ACWY\_D Group. 80% CI are obtained from Analysis of Covariance model fitted to pooled Serogroup B Strains. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|1.02|||||TWO_SIDED|80.0|0.86|1.22|||ANCOVA|An interaction between strain and pre-vaccination log transformed titer is included in the model to fit to the serogroup B test strain data only.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the pooled B strains, one month after first vaccination.||1.22|0.86|
71940312|NCT03587207|143401253|OTHER|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.29|||||TWO_SIDED|80.0|1.02|1.63|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.63|1.02|
71940313|NCT03587207|143401253|OTHER|96217 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.93|||||TWO_SIDED|80.0|0.75|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.15|0.75|
71940314|NCT03587207|143401253|OTHER|NZ98/254 strain- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|1.01|||||TWO_SIDED|80.0|0.8|1.29|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.||1.29|0.80|
71940315|NCT03587207|143401253|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Odds Ratio (OR)|1.08|||||TWO_SIDED|80.0|0.87|1.36|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.36|0.87|
71940316|NCT03587207|143401253|OTHER|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.77|||||TWO_SIDED|80.0|0.58|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup A, one month after first vaccination.||1.03|0.58|
71940317|NCT03587207|143401253|OTHER|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D Group.|Geometric mean ratio|0.84|||||TWO_SIDED|80.0|0.62|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup C, one month after first vaccination.||1.13|0.62|
71940318|NCT03587207|143401253|OTHER|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.68|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup W, one month after first vaccination.||1.13|0.68|
71940319|NCT03587207|143401253|OTHER|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY\_S group and rMenBOMV+ACWY\_D group.|Geometric mean ratio|0.76|||||TWO_SIDED|80.0|0.54|1.08|||ANCOVA|The model is fitted to each serogroup/strain separately.||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY\_S versus rMenBOMV+ACWY\_D study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.08|0.54|
71940320|NCT03587207|143401253|OTHER|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.09|0.69|
71940321|NCT03587207|143401253|OTHER|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.73|||||TWO_SIDED|80.0|0.58|0.9|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.90|0.58|
71940322|NCT03587207|143401253|OTHER|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.78|||||TWO_SIDED|80.0|0.61|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.00|0.61|
71940323|NCT03587207|143401253|OTHER|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.86|||||TWO_SIDED|80.0|0.68|1.07|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.07|0.68|
71940324|NCT03587207|143401253|OTHER|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.46|||||TWO_SIDED|80.0|0.35|0.62|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup A, one month after first vaccination.||0.62|0.35|
71940325|NCT03587207|143401253|OTHER|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.22|||||TWO_SIDED|80.0|0.91|1.65|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup C, one month after first vaccination.||1.65|0.91|
71940326|NCT03587207|143401253|OTHER|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|1.34|||||TWO_SIDED|80.0|1.04|1.72|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup W, one month after first vaccination.||1.72|1.04|
71940327|NCT03587207|143401253|OTHER|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY\_S group.|Geometric mean ratio|0.98|||||TWO_SIDED|80.0|0.7|1.38|||ANCOVA|The model is fitted to each serogroup/strain separately.||Other unknown interference in MenABCWY versus rMenBOMV+ACWY\_S study groups, on the Meningitis serogroup Y, one month after first vaccination.||1.38|0.70|
71940328|NCT03587207|143401253|OTHER|M14459 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group.|Geometric mean ratio|1.05|||||TWO_SIDED|80.0|0.83|1.32|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.32|0.83|
71940329|NCT03587207|143401253|OTHER|96217 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.8|||||TWO_SIDED|80.0|0.64|1.0|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.00|0.64|
71940330|NCT03587207|143401253|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.88|||||TWO_SIDED|80.0|0.69|1.13|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.13|0.69|
71940331|NCT03587207|143401253|OTHER|M07-0241084 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_S group and rMenBOMV group|Geometric mean ratio|0.95|||||TWO_SIDED|80.0|0.76|1.19|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.19|0.76|
71940332|NCT03587207|143401253|OTHER|M14459 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.81|||||TWO_SIDED|80.0|0.64|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.||1.03|0.64|
71940333|NCT03587207|143401253|OTHER|96217 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometric mean ratio|0.87|||||TWO_SIDED|80.0|0.69|1.09|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||1.09|0.69|
71940334|NCT03587207|143401253|OTHER|NZ98/254 strain -Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.87|||||TWO_SIDED|80.0|0.68|1.12|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||1.12|0.68|
71940335|NCT03587207|143401253|OTHER|M07-0241084 strain-Between group ratio for comparison of rMenBOMV\_ACWY\_D group and rMenBOMV group|Geometrical mean ratio|0.88|||||TWO_SIDED|80.0|0.7|1.1|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY\_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.10|0.70|
71940336|NCT03587207|143401253|OTHER|M14459 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.91|||||TWO_SIDED|80.0|0.71|1.15|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.||1.15|0.71|
71940337|NCT03587207|143401253|OTHER|96217 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.58|||||TWO_SIDED|80.0|0.47|0.73|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.||0.73|0.47|
71761126|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-3.04||||0.0393|TWO_SIDED|95.0|-5.93|-0.15||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Pain|||-0.15|-5.93|0.0393
71693488|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.6|STANDARD_ERROR_OF_MEAN|10.97||0.4338||95.0|-30.2|13.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-30.2|0.4338
71693489|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.4|STANDARD_ERROR_OF_MEAN|10.99||0.0647||95.0|-42.0|1.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-42.0|0.0647
71693490|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|10.61||0.5651||95.0|-27.0|14.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.8|-27.0|0.5651
71940338|NCT03587207|143401253|OTHER|NZ98/254 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.69|||||TWO_SIDED|80.0|0.54|0.89|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.||0.89|0.54|
71940339|NCT03587207|143401253|OTHER|M07-0241084 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.82|||||TWO_SIDED|80.0|0.65|1.03|||ANCOVA|The model is fitted to each serogroup/strain separately.||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.||1.03|0.65|
71693491|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.6|STANDARD_ERROR_OF_MEAN|11.16||0.1634||95.0|-37.6|6.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.4|-37.6|0.1634
71693492|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.2|STANDARD_ERROR_OF_MEAN|10.77||0.2209||95.0|-34.4|8.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.0|-34.4|0.2209
71693493|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.5|STANDARD_ERROR_OF_MEAN|10.84||0.1293||95.0|-37.8|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-37.8|0.1293
71693494|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.8|STANDARD_ERROR_OF_MEAN|11.06||0.0161||95.0|-48.5|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-48.5|0.0161
71693495|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|10.67||0.8506||95.0|-23.0|19.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-23.0|0.8506
71693496|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-30.9|STANDARD_ERROR_OF_MEAN|11.31||0.0067||95.0|-53.2|-8.6|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-8.6|-53.2|0.0067
71693497|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-13.8|STANDARD_ERROR_OF_MEAN|10.76||0.1997||95.0|-35.0|7.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-35.0|0.1997
71940340|NCT00966953|143401261|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||The null hypothesis states that there is no difference between groups.||||0.05
71940341|NCT01734772|143401275|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|149.38|STANDARD_DEVIATION|37.6||0.9456||90.0|124.388|179.383||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||179.383|124.388|0.9456
71940342|NCT01734772|143401275|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|126.47|STANDARD_DEVIATION|33.3||0.5481||90.0|107.363|148.967||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||148.967|107.363|0.5481
71940343|NCT01734772|143401275|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|127.01|STANDARD_DEVIATION|31.6||0.5665||90.0|108.047|149.295||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.295|108.047|0.5665
71940344|NCT01734772|143401276|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|164.74|STANDARD_DEVIATION|42.9||0.9841||90.0|133.945|202.619||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||202.619|133.945|0.9841
71940345|NCT01734772|143401276|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|geometric Mean Ratio|128.61|STANDARD_DEVIATION|39.0||0.6003||90.0|106.37|155.495||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||155.495|106.370|0.6003
71940346|NCT01734772|143401276|NON_INFERIORITY_OR_EQUIVALENCE|Relative bioavailability|gMean Ratio|123.82|STANDARD_DEVIATION|36.9||0.4656||90.0|102.695|149.288||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.|||149.288|102.695|0.4656
71940347|NCT01600495|143401277|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||Mixed Models Analysis|||||||0.01
71940348|NCT01600495|143401278|SUPERIORITY_OR_OTHER|||||||0.25||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.25
71940349|NCT01600495|143401280|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||Fisher Exact|||Fisher's exact test||||<0.01
71940350|NCT02097121|143401281|SUPERIORITY||LS Mean Difference|-0.98|STANDARD_ERROR_OF_MEAN|1.107|=|0.3802|TWO_SIDED|95.0|-3.203|1.243|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||1.243|-3.203|= 0.3802
71940351|NCT02097121|143401281|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.154|=|0.733|TWO_SIDED|95.0|-1.921|2.712|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used."||2.712|-1.921|= 0.733
71940352|NCT02097121|143401282|SUPERIORITY||LS Mean Difference|0.82|STANDARD_ERROR_OF_MEAN|1.442|=|0.5743|TWO_SIDED|95.0|-2.082|3.713|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||3.713|-2.082|= 0.5743
71940353|NCT02097121|143401282|SUPERIORITY||LS Mean Difference|2.15|STANDARD_ERROR_OF_MEAN|1.455|=|0.1451|TWO_SIDED|95.0|-0.769|5.078|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||5.078|-0.769|= 0.1451
71940354|NCT02097121|143401283|SUPERIORITY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|1.434|=|0.8206|TWO_SIDED|95.0|-3.205|2.551|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.551|-3.205|= 0.8206
71940355|NCT02097121|143401283|SUPERIORITY||LS Mean Difference|0.07|STANDARD_ERROR_OF_MEAN|1.434|=|0.9604|TWO_SIDED|95.0|-2.807|2.95|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||2.95|-2.807|= 0.9604
71940356|NCT02097121|143401285|SUPERIORITY||LS Mean Difference|35.33|STANDARD_ERROR_OF_MEAN|22.175|=|0.1174|TWO_SIDED|95.0|-9.207|79.873|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||79.873|-9.207|= 0.1174
71940357|NCT02097121|143401285|SUPERIORITY||LS Mean Difference|34.11|STANDARD_ERROR_OF_MEAN|23.722|=|0.1567|TWO_SIDED|95.0|-13.536|81.76|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||81.76|-13.536|= 0.1567
71940358|NCT02097121|143401286|SUPERIORITY||LS Mean Difference|-1.32|STANDARD_ERROR_OF_MEAN|4.091|=|0.7481|TWO_SIDED|95.0|-9.553|6.909|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||6.909|-9.553|= 0.7481
71693498|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-26.4|STANDARD_ERROR_OF_MEAN|10.9||0.0159||95.0|-47.9|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-5.0|-47.9|0.0159
71693499|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.8|STANDARD_ERROR_OF_MEAN|10.98||0.0388||95.0|-44.4|-1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.2|-44.4|0.0388
71693500|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|10.73||0.9962||95.0|-21.2|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-21.2|0.9962
71693501|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.8|STANDARD_ERROR_OF_MEAN|11.41||0.0839||95.0|-42.3|2.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.7|-42.3|0.0839
71693502|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|10.83||0.5216||95.0|-28.3|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-28.3|0.5216
71693503|NCT00676403|142901932|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-21.3|STANDARD_ERROR_OF_MEAN|10.98||0.0534||95.0|-42.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.3|-42.9|0.0534
71693504|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.8|STANDARD_ERROR_OF_MEAN|5.89||0.0199||95.0|2.2|25.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.4|2.2|0.0199
71693505|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|5.78||0.0768||95.0|-1.1|21.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.7|-1.1|0.0768
71693506|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.91||0.0642||95.0|-0.7|22.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.6|-0.7|0.0642
71693507|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|6.6|STANDARD_ERROR_OF_MEAN|5.88||0.2643||95.0|-5.0|18.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.2|-5.0|0.2643
71693508|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.2|STANDARD_ERROR_OF_MEAN|5.8||0.0358||95.0|0.8|23.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.7|0.8|0.0358
71940359|NCT02097121|143401286|SUPERIORITY||LS Mean Difference|1.85|STANDARD_ERROR_OF_MEAN|4.299|=|0.6691|TWO_SIDED|95.0|-6.799|10.498|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||10.498|-6.799|= 0.6691
71940360|NCT02097121|143401287|SUPERIORITY||LS Mean Difference|-0.03|STANDARD_ERROR_OF_MEAN|0.343|=|0.9297|TWO_SIDED|95.0|-0.721|0.661|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.661|-0.721|= 0.9297
71693509|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.93||0.0428||95.0|0.4|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.4|0.0428
71693510|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|5.81||0.1993||95.0|-4.0|18.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.9|-4.0|0.1993
71693511|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.9|STANDARD_ERROR_OF_MEAN|6.04||0.0331||95.0|1.1|24.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.8|1.1|0.0331
71693512|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1|STANDARD_ERROR_OF_MEAN|5.91||0.0415||95.0|0.5|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.8|0.5|0.0415
71693513|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.8|STANDARD_ERROR_OF_MEAN|5.83||0.0295||95.0|1.3|24.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.3|1.3|0.0295
71693514|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|6.01||0.1267||95.0|-2.6|21.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.6|0.1267
71693515|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7|STANDARD_ERROR_OF_MEAN|5.84||0.4175||95.0|-6.8|16.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.2|-6.8|0.4175
71693516|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.0|STANDARD_ERROR_OF_MEAN|6.09||0.0342||95.0|1.0|25.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.0|1.0|0.0342
71693517|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7|STANDARD_ERROR_OF_MEAN|5.96||0.1038||95.0|-2.0|21.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.5|-2.0|0.1038
71693518|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.6|STANDARD_ERROR_OF_MEAN|5.98||0.0537||95.0|-0.2|23.4|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.4|-0.2|0.0537
71693519|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.6|STANDARD_ERROR_OF_MEAN|5.99||0.0772||95.0|-1.2|22.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.4|-1.2|0.0772
71693520|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.8|STANDARD_ERROR_OF_MEAN|5.81||0.1296||95.0|-2.6|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-2.6|0.1296
71940361|NCT02097121|143401287|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.357|=|0.3976|TWO_SIDED|95.0|-1.022|0.413|||ANCOVA|||Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.||0.413|-1.022|= 0.3976
71940362|NCT02097121|143401288|SUPERIORITY||LS Mean Difference|0.3|STANDARD_ERROR_OF_MEAN|0.302|=|0.3309|TWO_SIDED|95.0|-0.311|0.904|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.904|-0.311|= 0.3309
71940363|NCT02097121|143401288|SUPERIORITY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.315|=|0.2235|TWO_SIDED|95.0|-0.245|1.024|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||1.024|-0.245|= 0.2235
71940364|NCT02097121|143401289|SUPERIORITY||LS Mean Difference|0.12|STANDARD_ERROR_OF_MEAN|0.274|=|0.6689|TWO_SIDED|95.0|-0.434|0.67|||ANCOVA|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.67|-0.434|= 0.6689
71940365|NCT02097121|143401289|SUPERIORITY||LS Mean Difference|0.15|STANDARD_ERROR_OF_MEAN|0.288|=|0.6076|TWO_SIDED|95.0|-0.431|0.729|||ANCOVA|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes \[a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period\]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented."||0.729|-0.431|= 0.6076
71940366|NCT02097121|143401290|SUPERIORITY||Risk difference %|15.5|||=|0.6092|TWO_SIDED|95.0|-18.94|46.19|||Cochran-Mantel-Haenszel|||"Treatment Difference of 100 U versus 25 U~Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||46.19|-18.94|= 0.6092
71761127|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|1.81||||0.0968|TWO_SIDED|95.0|-0.33|3.96||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Physical Functioning|||3.96|-0.33|0.0968
71940367|NCT02097121|143401290|SUPERIORITY||Risk difference %|17.6|||=|0.4824|TWO_SIDED|95.0|-16.2|48.9|||Cochran-Mantel-Haenszel|||"Treatment Difference of 50 U versus 25 U~Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or \> 6 episodes over the 2-day diary collection period)."||48.9|-16.2|= 0.4824
71940368|NCT00661999|143401301|SUPERIORITY_OR_OTHER|||||||0.39||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.39
71940369|NCT00661999|143401301|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.||||0.73
71940370|NCT00661999|143401303|SUPERIORITY_OR_OTHER|||||||0.725||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.7250
71940371|NCT00661999|143401303|SUPERIORITY_OR_OTHER|||||||0.87||95.0|||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.||||0.8700
71940372|NCT00661999|143401304|SUPERIORITY_OR_OTHER|||||||0.6639||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.6639
71940373|NCT00661999|143401304|SUPERIORITY_OR_OTHER|||||||0.566||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.5660
71940374|NCT00661999|143401305|SUPERIORITY_OR_OTHER|||||||0.1124||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.1124
71940375|NCT00661999|143401305|SUPERIORITY_OR_OTHER|||||||0.2051||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.||||0.2051
71940376|NCT00661999|143401306|SUPERIORITY_OR_OTHER|||||||0.0648||95.0|||||Log Rank|||||||0.0648
71940377|NCT00661999|143401308|SUPERIORITY_OR_OTHER|||||||0.61||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.61
71940378|NCT00661999|143401308|SUPERIORITY_OR_OTHER|||||||0.44||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.44
71940379|NCT00661999|143401309|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.62
71940380|NCT00661999|143401309|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.30
71940381|NCT00661999|143401310|SUPERIORITY_OR_OTHER|||||||0.19||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.19
71940382|NCT00661999|143401310|SUPERIORITY_OR_OTHER|||||||0.17||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.17
71940383|NCT00661999|143401311|SUPERIORITY_OR_OTHER|||||||0.73||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.73
71940384|NCT00661999|143401311|SUPERIORITY_OR_OTHER|||||||0.83||95.0|||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.||||0.83
71940385|NCT00661999|143401312|SUPERIORITY_OR_OTHER|||||||0.3852||95.0||||Test Comparison for Week 1 Level|Kruskal-Wallis|||||||0.3852
71940386|NCT00661999|143401312|SUPERIORITY_OR_OTHER|||||||0.0663||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0663
71940387|NCT00661999|143401312|SUPERIORITY_OR_OTHER|||||||0.322||95.0||||Test Comparison for Week 16 Level|Kruskal-Wallis|||||||0.3220
71940388|NCT00661999|143401313|SUPERIORITY_OR_OTHER|||||||0.1826||95.0||||Test Comparison for Week 1 Level.|Kruskal-Wallis|||||||0.1826
71940389|NCT00661999|143401313|SUPERIORITY_OR_OTHER|||||||0.0113||95.0||||Test comparison for week 7 level|Kruskal-Wallis|||||||0.0113
71940390|NCT00661999|143401313|SUPERIORITY_OR_OTHER|||||||0.3358||95.0||||Test Comparison for week 16 level|Kruskal-Wallis|||||||0.3358
71940391|NCT00661999|143401314|SUPERIORITY_OR_OTHER|||||||0.9022||95.0||||Test comparison for Baseline level.|Kruskal-Wallis|||||||0.9022
71940392|NCT00661999|143401314|SUPERIORITY_OR_OTHER|||||||0.0002||95.0||||Test Comparison for Week 7 Level.|Kruskal-Wallis|||||||0.0002
71940393|NCT00661999|143401314|SUPERIORITY_OR_OTHER|||||||0.0022||95.0||||Test Comparison for Week 16 Level.|Kruskal-Wallis|||||||0.0022
71940394|NCT00661999|143401315|SUPERIORITY_OR_OTHER|||||||0.1137||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1137
71940395|NCT00661999|143401315|SUPERIORITY_OR_OTHER|||||||0.8042||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.8042
71940396|NCT00661999|143401315|SUPERIORITY_OR_OTHER|||||||0.2016||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2016
71940397|NCT00661999|143401316|SUPERIORITY_OR_OTHER|||||||0.1139||95.0||||Test comparison for baseline level.|Kruskal-Wallis|||||||0.1139
71940398|NCT00661999|143401316|SUPERIORITY_OR_OTHER|||||||0.0424||95.0||||Test comparison for week 7 level.|Kruskal-Wallis|||||||0.0424
71940399|NCT00661999|143401316|SUPERIORITY_OR_OTHER|||||||0.2025||95.0||||Test comparison for week 16 level.|Kruskal-Wallis|||||||0.2025
71940400|NCT03708211|143401386|OTHER||Ratio of geometric mean|0.9359|||||TWO_SIDED|90.0|0.8084|1.0835||||||Following log-transformation, PK parameters were analyzed by analysis of variance (ANOVA) fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90 percent (%) confidence intervals (CIs) for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.0835|0.8084|
71940401|NCT03708211|143401387|OTHER||Ratio of geometric mean|1.0036|||||TWO_SIDED|90.0|0.8992|1.1201||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1201|0.8992|
71940402|NCT03708211|143401388|OTHER||Ratio of geometric mean|1.0071|||||TWO_SIDED|90.0|0.9033|1.1227||||||Following log-transformation, PK parameters were analyzed by ANOVA fitting terms for treatment group, sequence and period. Participants within sequence were treated as a random effect. The obtained point estimates and adjusted 90% CIs for difference in treatment were exponentially back transformed to provide point and confidence interval estimates for the ratios of interest appropriately.||1.1227|0.9033|
71940403|NCT01508936|143401399|SUPERIORITY_OR_OTHER||slope difference|0.3007|STANDARD_ERROR_OF_MEAN|0.2559||0.2407|TWO_SIDED|||||The interaction was tested at the significance level 0.10 using the FAS|Regression, Linear||Active - Placebo|The primary analysis was the linear regression model with model effects including treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count. A significant treatment by baseline eosinophil interaction would indicate that treatment difference varies by the baseline eosinophil count.||||0.2407
71940404|NCT01508936|143401400|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076|STANDARD_ERROR_OF_MEAN|0.0417||0.0697|TWO_SIDED|95.0|-0.006|0.158||Statistical significance level is 0.05.|Regression, Linear|treatment, blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as fixed effects.|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.158|-0.006|0.0697
71940405|NCT01508936|143401401|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.123|STANDARD_ERROR_OF_MEAN|0.0762||0.1072|TWO_SIDED|95.0|-0.273|0.027||significance level of 0.05|t-test, 2 sided|Fixed effects for treatment, hx of asthma exacerbation, sex, visit, and interaction of treatment and visit; covariates for height and baseline value|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~* Lung function as measured by FEV1~* ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."||0.027|-0.273|0.1072
71940406|NCT04603937|143401418|NON_INFERIORITY|The maximum clinically acceptable true difference between KSI-301 and aflibercept participants to be considered non-inferior is 4.5 ETDRS letters, i.e. the non-inferiority margin|Adjusted mean difference|-4.7|STANDARD_ERROR_OF_MEAN|0.97|>|0.9999|TWO_SIDED|95.04|-6.65|-2.81|||Mixed Models Analysis|MMRM model with treatment, visit, treatment by visit interaction, randomization stratification factors, and continuous baseline BCVA and OCT CST.||||-2.81|-6.65|> 0.9999
71940407|NCT04603937|143401419|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e. the non-inferiority margin is 10%|Difference of weighted percentages|0.6|||<|0.0001|TWO_SIDED|95.04|-0.7|2.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by study identifier and randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||2|-0.7|<0.0001
71940408|NCT04603937|143401420|NON_INFERIORITY|The maximum clinically acceptable non-inferiority margin between KSI-301 and aflibercept subjects is 10% to be considered non-inferior, i.e the non-inferiority margin is 10%|Difference of weighted percentages|1.2|||<|0.0001|TWO_SIDED|95.04|-1.4|3.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haentzel test stratified by randomization stratification variables.|Weighted percentages are based on weighted average of observed estimates across strata using CMH weights. The CI are based on the normal approximation to the binomial proportions.|||3.9|-1.4|<0.0001
71940409|NCT02683187|143401440|EQUIVALENCE|Insulin secretion, determined by insulin or C-peptide values in the 10 minutes after arginine infusion will be compared as a repeated measure for each subject in a 2 x 2 analysis of sitagliptin/placebo and Exendin-9/saline.|Median Difference (Final Values)|371.0|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||< 0.05
71940410|NCT02585258|143401441|SUPERIORITY||mean difference over 2-years|-0.37|||<|0.0001|ONE_SIDED|95.0||-0.23||one-sided.|Mixed Models Analysis||placebo is reference. Negative difference is beneficial, means lower disease activity in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.23||<0.0001
71940411|NCT02585258|143401442|SUPERIORITY||Risk Ratio (RR)|1.24||||0.02|ONE_SIDED|95.0|1.04|||one-sided|GEE||prednisolone/placebo|mixed model reports the effect of treatment, adjusted for stratification factors|||1.04|0.02
71940412|NCT02585258|143401443|SUPERIORITY||mean differences over 2 years|-1.67||||0.003|ONE_SIDED|95.0||-0.68||one-sided|Regression, Linear||placebo is reference. Negative difference means less damage progression in prednisolone group.|mixed model reports the effect of treatment, adjusted for stratification factors||-0.68||0.003
71940413|NCT01919190|143401444|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.8|TWO_SIDED||||||ANCOVA|||||||>0.8
71940414|NCT01919190|143401445|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0456|TWO_SIDED||||||Mixed Models Analysis|||||||0.0456
71693521|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.0|STANDARD_ERROR_OF_MEAN|6.06||0.014||95.0|3.1|27.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||27.0|3.1|0.0140
71693522|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|5.93||0.0642||95.0|-0.7|22.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.7|-0.7|0.0642
71693523|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.7|STANDARD_ERROR_OF_MEAN|5.92||0.073||95.0|-1.0|22.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.3|-1.0|0.0730
71693524|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|6.01||0.0215||95.0|2.1|25.8|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.8|2.1|0.0215
71693525|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|5.84||0.3785||95.0|-6.4|16.7|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.7|-6.4|0.3785
71693526|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.1|STANDARD_ERROR_OF_MEAN|6.12||0.0089||95.0|4.1|28.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.2|4.1|0.0089
71693527|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2|STANDARD_ERROR_OF_MEAN|5.96||0.0609||95.0|-0.5|23.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.0|-0.5|0.0609
71940415|NCT00655642|143401450|NON_INFERIORITY_OR_EQUIVALENCE|Based on the aforementioned values, we calculated a sample size for each treatment arm of 131 patients. We increased this sample estimate to 150 per treatment arm (total of 600 patients) to account for anticipated study attrition. Based on an unplanned interim conditional power futility analysis done at 30% information fraction, the decision was made to end the trial early.The futility analysis found the observed differences were far less than what was deemed clinically important.|Median Difference (Final Values)|12.0|STANDARD_DEVIATION|25.0||0.16||||||Being aware of the multiple comparison issues, we deliberately chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|Kruskal-Wallis|We computed the effect of the 3 treatments relative to ondansetron.|Change in VAS score was calculated as (VAS 30 min - VAS baseline). We calculated the differences in median VAS reductions for each arm relative to ondansetron.|The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.||||0.16
71693528|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.4|STANDARD_ERROR_OF_MEAN|5.95||0.0064||95.0|4.7|28.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.1|4.7|0.0064
71693529|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.7|STANDARD_ERROR_OF_MEAN|6.01||0.0241||95.0|1.8|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|1.8|0.0241
71693530|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.6|STANDARD_ERROR_OF_MEAN|5.86||0.1032||95.0|-2.0|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.1|-2.0|0.1032
71940416|NCT00797108|143401451|SUPERIORITY_OR_OTHER||Clinical Cure Difference|27.5|||||TWO_SIDED|80.0|-4.0|55.3||||||Two-sided 80% confidence interval (CI) for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||55.3|-4.0|
71940417|NCT00797108|143401451|SUPERIORITY_OR_OTHER||Clinical Cure Difference|25.0|||||TWO_SIDED|80.0|-13.1|57.9||||||Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.||57.9|-13.1|
71940418|NCT02270736|143401474|SUPERIORITY||Least square mean (LS-mean) difference|-0.06|STANDARD_ERROR_OF_MEAN|0.019|=|0.0012|TWO_SIDED|95.0|-0.1|-0.03|||MMRM|||Least square mean (LS-Mean) is from a mixed model repeated measurement (MMRM) analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.03|-0.1|= 0.0012
71940419|NCT02270736|143401475|SUPERIORITY||Least square mean (LS-mean) difference|0.28|STANDARD_ERROR_OF_MEAN|0.127|=|0.032|TWO_SIDED|95.0|0.02|0.53|||MMRM|||LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline Modified Teacher Drooling Scale (mTDS) score as covariate.||0.53|0.02|= 0.032
71940420|NCT02270736|143401477|SUPERIORITY||Least square mean (LS-mean) difference|-0.09|STANDARD_ERROR_OF_MEAN|0.019|<|0.0001|TWO_SIDED|95.0|-0.12|-0.05|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.05|-0.12|<0.0001
71940421|NCT02270736|143401477|SUPERIORITY||Least square mean (LS-mean) difference|-0.1|STANDARD_ERROR_OF_MEAN|0.021|<|0.0001|TWO_SIDED|95.0|-0.14|-0.06|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline uSFR score as covariate.||-0.06|-0.14|<0.0001
71940422|NCT02270736|143401478|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.116|=|0.0008|TWO_SIDED|95.0|0.17|0.63|||MMRM|||Statistical analysis at Week 8: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.63|0.17|=0.0008
71940423|NCT02270736|143401478|SUPERIORITY||Least square mean (LS-mean) difference|0.4|STANDARD_ERROR_OF_MEAN|0.132|=|0.0026|TWO_SIDED|95.0|0.14|0.66|||MMRM|||Statistical analysis at Week 12: LS-Mean is from a MMRM analysis model with treatment group, pooled investigation sites, and age groups as fixed factors, visit\*treatment as interaction term, visit as repeated factor, and baseline mTDS score as covariate.||0.66|0.14|=0.0026
71940424|NCT04908748|143401488|SUPERIORITY||Least squares mean difference|-29.1|||<|0.0001|TWO_SIDED|95.0|-32.2|-26.0|||ANCOVA|||||-26.0|-32.2|< 0.0001
71940425|NCT00757601|143401505|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 AUC (0-∞).~The GMR (fed/fasted) was calculated using the geometric mean AUC (0-∞) of the fed state divided by the geometric mean AUC (0-∞) fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.03||||||95.0|||||Mixed-Effect Model|||A linear mixed-effect model was used to estimate the geometric mean AUC (0-∞) for MK1006 at every dose level.||||
71940426|NCT00757601|143401506|NON_INFERIORITY_OR_EQUIVALENCE|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR\[fed/fasted\]) of MK1006 Cmax.~The GMR (fed/fasted) was calculated using the geometric mean Cmax of the fed state divided by the geometric mean Cmax fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.14||||||95.0|||||Mixed-effect Model|||A linear mixed-effect model was used to estimate the geometric mean Cmax for MK1006 at every dose level.||||
71940427|NCT03194464|143401514|OTHER|||||||0.15||||||The a priori threshold for statistical significance was established at p \<.05 (non-adjusted).|ANOVA|||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by less affected hand exercise to task-failure and to determine the time course and recovery of this effect.||||0.15
71940428|NCT03194464|143401515|SUPERIORITY|||||||0.83||||||Statistical Significance established as p \<.05|ANOVA|Repeated-Measures ANOVA||We performed repeated measures analysis of variance (RM-ANOVA) to determine if intracortical inhibition, as measured by SICI, in the ipsilesional hemisphere was altered by repeated sessions of less affected hand exercise to task-failure. Pre-exercise SICI was compared between Session1 and Session8.||||.83
71940429|NCT03194464|143401516|OTHER|||||||0.204|||||||ANOVA|||RM-ANOVA||||0.204
71940430|NCT03194464|143401517|SUPERIORITY|||||||0.004||||||statistical significance was established a priori at p \<.05|ANOVA|repeated measures ANOVA comparing Session8 vs. Session1 performance||We performed repeated measures analysis of variance (RM-ANOVA) to determine if motor dexterity, as measured by the BBT, was improved by repeated sessions of non-paretic hand exercise to task-failure. BBT performance was compared between Session1 and Session8.||||.004
71940431|NCT02428699|143401622|SUPERIORITY||Mean Difference (Net)|5.16|||<|0.0001|TWO_SIDED|95.0|2.79|7.53|||ANCOVA|Subject as random effect,treatment and period as fixed effects,subject and period level baseline values for plasma total and free acids as covariates|Difference is test minus reference such that a positive difference favors the test treatment.|||7.53|2.79|<.0001
71761128|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|1.78||||0.1449|TWO_SIDED|95.0|-0.61|4.17||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Global Health Status/QOL|||4.17|-0.61|0.1449
71940432|NCT02483975|143401658|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.92|||||TWO_SIDED|95.0|0.804|1.0505||||||||1.0505|0.8040|
71940433|NCT02483975|143401659|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.8096|1.062||||||||1.0620|0.8096|
71940434|NCT02483975|143401660|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.93|||||TWO_SIDED|95.0|0.81|1.06||||||||1.06|0.81|
71940435|NCT02483975|143401661|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.79|||||TWO_SIDED|95.0|0.61|1.03||||||||1.03|0.61|
71940436|NCT02483975|143401662|SUPERIORITY_OR_OTHER_LEGACY||Least square Geometric Mean ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||||1.07|0.72|
71940437|NCT00818883|143401663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-8.3|-2.9||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.9|-8.3|<0.001
71940438|NCT00818883|143401663|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.0|||<|0.001||95.0|-7.5|-2.5||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.5|-7.5|<0.001
71940439|NCT00818883|143401664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.7|||<|0.001|TWO_SIDED|95.0|-5.2|-2.2||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.2|-5.2|<0.001
71940440|NCT00818883|143401664|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.7|||<|0.001|TWO_SIDED|95.0|-4.1|-1.3||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.3|-4.1|<0.001
71940441|NCT00818883|143401665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.3|||<|0.001|TWO_SIDED|95.0|-10.5|-4.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-4.2|-10.5|<0.001
71940442|NCT00818883|143401665|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.001|TWO_SIDED|95.0|-6.8|-1.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.7|-6.8|0.001
71940443|NCT00818883|143401666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|||<|0.001|TWO_SIDED|95.0|-6.3|-2.3||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.3|-6.3|<0.001
71940444|NCT00818883|143401666|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.006|TWO_SIDED|95.0|-4.2|-0.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-0.7|-4.2|0.006
71693531|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|16.6|STANDARD_ERROR_OF_MEAN|6.16||0.0076||95.0|4.4|28.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||28.7|4.4|0.0076
71940445|NCT00818883|143401667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.8|||<|0.001|TWO_SIDED|95.0|-8.4|-3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-3.2|-8.4|<0.001
71940446|NCT00818883|143401667|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2|||<|0.001|TWO_SIDED|95.0|-6.4|-2.0||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-2.0|-6.4|<0.001
71693532|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.2|STANDARD_ERROR_OF_MEAN|5.96||0.1257||95.0|-2.6|20.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.9|-2.6|0.1257
71693533|NCT00676403|142901933|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|STANDARD_ERROR_OF_MEAN|5.95||0.0131||95.0|3.2|26.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.6|3.2|0.0131
71693534|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|6.94||0.1824||95.0|-23.0|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.0|0.1824
71693535|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.8||0.0767||95.0|-25.5|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-25.5|0.0767
71693536|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.1|STANDARD_ERROR_OF_MEAN|7.11||0.0492||95.0|-28.1|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-28.1|0.0492
71693537|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.7|STANDARD_ERROR_OF_MEAN|6.84||0.2023||95.0|-22.2|4.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-22.2|0.2023
71693538|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-17.4|STANDARD_ERROR_OF_MEAN|6.83||0.0116||95.0|-30.9|-3.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-3.9|-30.9|0.0116
71693539|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|7.01||0.1819||95.0|-23.2|4.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-23.2|0.1819
71693540|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.3|STANDARD_ERROR_OF_MEAN|6.76||0.2806||95.0|-20.6|6.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.0|-20.6|0.2806
71693541|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.13||0.1465||95.0|-24.4|3.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.4|0.1465
71693542|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-19.6|STANDARD_ERROR_OF_MEAN|6.85||0.0046||95.0|-33.1|-6.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-6.1|-33.1|0.0046
71693543|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.4|STANDARD_ERROR_OF_MEAN|6.92||0.0187||95.0|-30.0|-2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-30.0|0.0187
71693544|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.5|STANDARD_ERROR_OF_MEAN|7.0||0.6128||95.0|-10.2|17.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.3|-10.2|0.6128
71761129|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|3.56||||0.0259|TWO_SIDED|95.0|0.43|6.7||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Role Functioning|||6.70|0.43|0.0259
71940447|NCT00818883|143401668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.8|||<|0.001|TWO_SIDED|95.0|-5.5|-2.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.||-2.1|-5.5|<0.001
71693545|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|6.76||0.3488||95.0|-19.7|7.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-19.7|0.3488
71693546|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.4|STANDARD_ERROR_OF_MEAN|7.17||0.1472||95.0|-24.5|3.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.7|-24.5|0.1472
71693547|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.2|STANDARD_ERROR_OF_MEAN|6.89||0.0791||95.0|-25.7|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|-25.7|0.0791
71693548|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-15.4|STANDARD_ERROR_OF_MEAN|6.97||0.0282||95.0|-29.1|-1.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.7|-29.1|0.0282
71693549|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.9|STANDARD_ERROR_OF_MEAN|7.08||0.1623||95.0|-23.9|4.0|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-23.9|0.1623
71940448|NCT00818883|143401668|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.6|||<|0.001|TWO_SIDED|95.0|-4.1|-1.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.||-1.1|-4.1|<0.001
71940449|NCT02684578|143401685|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects regression|||||||0.39
71940450|NCT02684578|143401686|SUPERIORITY|||||||0.97||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.97
71940451|NCT02684578|143401687|SUPERIORITY|||||||0.12||||||The threshold for statistical significance was p = 0.05.|Linear mixed-effects|||||||0.12
71693550|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|6.84||0.3739||95.0|-19.6|7.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-19.6|0.3739
71693551|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.2|STANDARD_ERROR_OF_MEAN|7.26||0.0517||95.0|-28.5|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.1|-28.5|0.0517
71693552|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|6.92||0.0815||95.0|-25.8|1.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.5|-25.8|0.0815
71940452|NCT01193608|143401764|SUPERIORITY_OR_OTHER||Mean change|113.53||||0.599|TWO_SIDED|80.0|-170.3|397.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||397.35|-170.30|0.599
71940453|NCT01193608|143401766|SUPERIORITY_OR_OTHER||Mean change|48.85||||0.297|TWO_SIDED|80.0|-11.79|109.48|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||109.48|-11.79|0.297
71940454|NCT01193608|143401768|SUPERIORITY_OR_OTHER||Mean change|-15.26||||0.6|TWO_SIDED|80.0|-53.54|23.02|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||23.02|-53.54|0.600
71940455|NCT01193608|143401770|SUPERIORITY_OR_OTHER||Mean change|1.23||||0.603|TWO_SIDED|80.0|-1.89|4.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group||4.35|-1.89|0.603
71940456|NCT00948675|143401781|SUPERIORITY_OR_OTHER_LEGACY|||||||0.176||95.0|||||Log Rank|||||||0.176
71940457|NCT00948675|143401782|SUPERIORITY_OR_OTHER_LEGACY|||||||0.61||95.0|||||Log Rank|||||||0.610
71693553|NCT00676403|142901934|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-20.9|STANDARD_ERROR_OF_MEAN|7.0||0.0031||95.0|-34.7|-7.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-7.1|-34.7|0.0031
71940458|NCT00948675|143401783|SUPERIORITY_OR_OTHER_LEGACY|||||||0.615||95.0|||||Log Rank|||||||0.615
71940459|NCT00948675|143401784|SUPERIORITY_OR_OTHER_LEGACY|||||||0.414||95.0|||||Pearson Chi-square Test|||||||0.414
71940460|NCT00948675|143401785|SUPERIORITY_OR_OTHER_LEGACY|||||||0.575||95.0|||||Pearson Chi-square Test|||||||0.575
71940461|NCT00571428|143401807|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.011||||||90.0|-0.015|0.037|||Mixed Models Analysis|Treatment group, treatment sequence, predose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||0.037|-0.015|
71940462|NCT00571428|143401808|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.062||||||90.0|0.035|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.090|0.035|
71940463|NCT00571428|143401809|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.035||||||90.0|-0.079|0.008|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.008|-0.079|
71940464|NCT00571428|143401810|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.03||||||90.0|-0.086|0.026|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit Number are fixed effects; subjects within treatment sequence is a random effect.||||0.026|-0.086|
71940465|NCT00571428|143401815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.694||||||90.0|0.525|2.862|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect.||||2.862|0.525|
71940466|NCT00571428|143401816|NON_INFERIORITY_OR_EQUIVALENCE|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.052||||||90.0|0.015|0.09|||Mixed Models Analysis|Treatment group, treatment sequence, pre-dose FEV1, \& Visit number are fixed effects; subject within treatment sequence is a random effect||||0.090|0.015|
71940467|NCT04087395|143401821|NON_INFERIORITY|To achieve non-inferiority, the observed p-value must be \<= 0.5 taking into account of the non-inferiority margin (i.e., 10mm difference in Pain VAS between the two treatment groups).|||||<|0.0001||||||One-sided paired student t-test|t-test, 1 sided|||||||<0.0001
71940468|NCT02796664|143401835|OTHER|Equality test||||||0.462|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and cerebral ischemic events including ischemic stroke and transient ischemic attack. The number of participants who suffered ischemic stroke and the number of paticipants who suffered transient ischemic attack were analyzed together to test the null hypothesis in two by two table.||||0.462
71940469|NCT02796664|143401836|OTHER|Equality test||||||0.34|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and modified Rankin Scale at follow-up.||||0.34
71940470|NCT02796664|143401837|OTHER|Equality test||||||0.13|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and flow change in steno-occlusive lesion.||||0.13
71940471|NCT02796664|143401837|OTHER|Equality test||||||0.17|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and flow change in collateral vessel.||||0.17
71940472|NCT02796664|143401838|OTHER|Equality test||||||0.74|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and periventricular white matter lesions at follow-up.||||0.74
71940473|NCT02796664|143401838|OTHER|Equality test||||||0.95|||||||Fisher Exact|||The null hypothesis is that there is no relationship between ginseng administration and deep white matter lesions at follow-up.||||0.95
71940474|NCT02796664|143401839|OTHER|Equality test||||||0.23|||||||Chi-squared|||The null hypothesis is that there is no relationship between ginseng administration and parenchymal ischemic lesions at follow-up.||||0.23
71940475|NCT02796664|143401840|OTHER|Equality test||||||0.79|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no relationship between ginseng administration and drug compliance at follow-up.||||0.79
71940476|NCT04128007|143401874|SUPERIORITY||Odds Ratio (OR)|14.65|||<|0.0001|TWO_SIDED|95.0|6.64|32.32|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|S-IGA Success at Week 8 Odds Ratio||32.32|6.64|<0.0001
71940477|NCT04128007|143401875|SUPERIORITY||Odds Ratio (OR)|8.8|||<|0.0001|TWO_SIDED|95.0|3.65|21.18|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|B-IGA Success at Week 8 Odds Ratio||21.18|3.65|<0.0001
71693554|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.88||0.3368||95.0|-8.0|23.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.1|-8.0|0.3368
71940478|NCT04128007|143401876|SUPERIORITY||Odds Ratio (OR)|4.06|||<|0.0001|TWO_SIDED|95.0|2.14|7.71|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 2 Odds Ratio||7.71|2.14|<0.0001
71940479|NCT04128007|143401876|SUPERIORITY||Odds Ratio (OR)|5.36|||<|0.0001|TWO_SIDED|95.0|2.93|9.78||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 4 Odds Ratio||9.78|2.93|<0.0001
71940480|NCT04128007|143401876|SUPERIORITY||Odds Ratio (OR)|9.74|||<|0.0001|TWO_SIDED|95.0|5.02|18.89||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|SI-NRS Success at Week 8 Odds Ratio||18.89|5.02|<0.0001
71940481|NCT04128007|143401877|SUPERIORITY||Least Squares Mean Difference|-19.6|||<|0.0001|TWO_SIDED|95.0|-27.4|-11.8|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 4 Change from Baseline||-11.8|-27.4|<0.0001
71693555|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.2|STANDARD_ERROR_OF_MEAN|7.75||0.4232||95.0|-21.5|9.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.1|-21.5|0.4232
71693556|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0|STANDARD_ERROR_OF_MEAN|8.09||0.7082||95.0|-12.9|19.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.0|-12.9|0.7082
71693557|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|7.7||0.9466||95.0|-15.7|14.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.7|-15.7|0.9466
71693558|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|7.72||0.3746||95.0|-22.1|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-22.1|0.3746
71693559|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|7.95||0.9336||95.0|-15.0|16.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.3|-15.0|0.9336
71693560|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.8|STANDARD_ERROR_OF_MEAN|7.71||0.2029||95.0|-25.0|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-25.0|0.2029
71693561|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.1|STANDARD_ERROR_OF_MEAN|8.18||0.3833||95.0|-23.3|9.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-23.3|0.3833
71693562|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8|STANDARD_ERROR_OF_MEAN|7.72||0.8152||95.0|-17.0|13.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.4|-17.0|0.8152
71693563|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|7.81||0.1739||95.0|-26.1|4.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.7|-26.1|0.1739
71693564|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|7.94||0.3392||95.0|-8.0|23.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.3|-8.0|0.3392
71693565|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|7.71||0.913||95.0|-16.0|14.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-16.0|0.9130
71940482|NCT04128007|143401877|SUPERIORITY||Least Squares Mean Difference|-27.5|||<|0.0001|TWO_SIDED|95.0|-35.5|-19.5|||ANCOVA|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.|Comparison of Week 8 Change from Baseline||-19.5|-35.5|<0.0001
71940483|NCT04128007|143401878|SUPERIORITY||Hazard Ratio (HR)|3.94|||<|0.0001|TWO_SIDED|95.0|2.764|5.616||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Log Rank||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.|Time to PSSI-50 Hazard Ratio||5.616|2.764|<0.0001
71693566|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|8.22||0.6||95.0|-20.5|11.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.9|-20.5|0.6000
71693567|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9|STANDARD_ERROR_OF_MEAN|7.75||0.4445||95.0|-9.3|21.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||21.2|-9.3|0.4445
71693568|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|7.85||0.9656||95.0|-15.8|15.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.1|-15.8|0.9656
71693569|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|8.02||0.5679||95.0|-11.2|20.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.4|-11.2|0.5679
71693570|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.5|STANDARD_ERROR_OF_MEAN|7.79||0.5619||95.0|-19.9|10.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-19.9|0.5619
71693571|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|8.31||0.993||95.0|-16.3|16.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.4|-16.3|0.9930
71693572|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1|STANDARD_ERROR_OF_MEAN|7.79||0.6892||95.0|-12.2|18.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.5|-12.2|0.6892
71693573|NCT00676403|142901935|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|7.89||0.4928||95.0|-21.0|10.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.1|-21.0|0.4928
71693574|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.6|STANDARD_ERROR_OF_MEAN|5.1||0.2719||95.0|-4.4|15.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.6|-4.4|0.2719
71693575|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.0|STANDARD_ERROR_OF_MEAN|5.02||0.693||95.0|-7.9|11.8|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||11.8|-7.9|0.6930
71693576|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|5.24||0.7178||95.0|-12.2|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-12.2|0.7178
71693577|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|4.96||0.8037||95.0|-11.0|8.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-11.0|0.8037
71693578|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7|STANDARD_ERROR_OF_MEAN|5.02||0.0832||95.0|-1.2|18.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.6|-1.2|0.0832
71940484|NCT04128007|143401879|SUPERIORITY||Odds Ratio (OR)|9.46|||<|0.0001|TWO_SIDED|95.0|4.81|18.61||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Cochran-Mantel-Haenszel||Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-75 at Week 8 Odds Ratio||18.61|4.81|<0.0001
71693579|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8|STANDARD_ERROR_OF_MEAN|5.17||0.3554||95.0|-5.4|14.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.9|-5.4|0.3554
71693580|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|4.96||0.9538||95.0|-9.5|10.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.0|-9.5|0.9538
71693581|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1|STANDARD_ERROR_OF_MEAN|5.26||0.5593||95.0|-13.4|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.4|0.5593
71693582|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|4.97||0.8663||95.0|-8.9|10.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-8.9|0.8663
71693583|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.0|STANDARD_ERROR_OF_MEAN|5.12||0.119||95.0|-2.1|18.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||18.1|-2.1|0.1190
71693584|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.4|STANDARD_ERROR_OF_MEAN|5.15||0.1544||95.0|-2.8|17.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.5|-2.8|0.1544
71693585|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|4.97||0.8439||95.0|-8.8|10.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.7|-8.8|0.8439
71940485|NCT04128007|143401880|SUPERIORITY||Odds Ratio (OR)|34.45|||<|0.0001|TWO_SIDED|95.0|8.49|139.77|||Cochran-Mantel-Haenszel|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.|PSSI-90 at Week 8 Odds Ratio||139.77|8.49|<0.0001
71940486|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|||<|0.001|TWO_SIDED|95.0|0.06|0.196|||Mixed Models Analysis|||||0.196|0.060|<0.001
71940487|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.147|||<|0.001|TWO_SIDED|95.0|0.077|0.216|||Mixed Models Analysis|||||0.216|0.077|<0.001
71940488|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.095||||0.006|TWO_SIDED|95.0|0.027|0.162|||Mixed Models Analysis|||||0.162|0.027|0.006
71940489|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|||<|0.001|TWO_SIDED|95.0|0.074|0.205|||Mixed Models Analysis|||||0.205|0.074|<0.001
71940490|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.186|||<|0.001|TWO_SIDED|95.0|0.113|0.259|||Mixed Models Analysis|||||0.259|0.113|<0.001
71940491|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079||||0.03|TWO_SIDED|95.0|0.008|0.151|||Mixed Models Analysis|||||0.151|0.008|0.030
71940492|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.134|||<|0.001|TWO_SIDED|95.0|0.064|0.204|||Mixed Models Analysis|||||0.204|0.064|<0.001
71940493|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.172|||<|0.001|TWO_SIDED|95.0|0.101|0.242|||Mixed Models Analysis|||||0.242|0.101|<0.001
71940494|NCT00950807|143401945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.003|TWO_SIDED|95.0|0.037|0.173|||Mixed Models Analysis|||||0.173|0.037|0.003
71761130|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|3.65||||0.0175|TWO_SIDED|95.0|0.64|6.65||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Functioning|||6.65|0.64|0.0175
71940495|NCT02129348|143401950|SUPERIORITY||Treatment Effect Difference|0.7||||0.53|TWO_SIDED|95.0|-1.4|2.7||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||Lithium will significantly reduce agitation/aggression compared to placebo. In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.7|-1.4|0.53
71940496|NCT02129348|143401951|SUPERIORITY||Treatment Effect Difference|2.11||||0.26|TWO_SIDED|95.0|0.73|6.13||The threshold for statistical significance was p = 0.05.|Chi-squared||Odds ratio and its 95% confidence interval were computed.|Change in both NPI core score (≥30% versus \<30%) and CGI behavior change (1 or 2 versus ≥3) were required for response; these two measures were then analyzed separately. A x² test was used to identify whether there was a change in NPI core scores and CGI scores from baseline to week 12.||6.13|0.73|0.26
71940497|NCT02129348|143401952|SUPERIORITY||Treatment Effect Difference|1.79||||0.25|TWO_SIDED|95.0|0.64|5.04||The threshold of statistical significance was p = 0.05.|Chi-squared|||CGI behavior change scores were categorized into responders versus non-responders (1 or 2 versus ≥3) using the last variable observation for drop-outs. A x² test was used to identify the percentage of participants in each group, lithium versus placebo, that improved from baseline to week 12.||5.04|0.64|0.25
71940498|NCT02129348|143401953|SUPERIORITY||Treatment Effect Difference|2.0||||0.21|TWO_SIDED|95.0|-1.1|5.1||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||5.1|-1.1|0.21
71940499|NCT02129348|143401954|SUPERIORITY||Treatment Effect Difference|-0.1||||0.91|TWO_SIDED|95.0|-2.6|2.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||2.4|-2.6|0.91
71940500|NCT02129348|143401955|SUPERIORITY||Treatment Effect Difference|0.1||||0.94|TWO_SIDED|95.0|-1.5|1.4||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= -0.02 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.4|-1.5|0.94
71940501|NCT02129348|143401956|SUPERIORITY||Treatment Effect Difference|0.2||||0.63|TWO_SIDED|95.0|-0.4|0.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis|||In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||0.8|-0.4|0.63
71940502|NCT02129348|143401957|SUPERIORITY||Treatment Effect Difference|3.2||||0.24|TWO_SIDED|95.0|-2.1|8.4||The threshold of statistical significance was p = 0.05.|Mixed Models Analysis||Effect size (d)= 0.44 (Cohen's D)|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||8.4|-2.1|0.24
71940503|NCT02129348|143401958|SUPERIORITY||Treatment Effect Difference|0.0||||0.96|TWO_SIDED|95.0|-1.7|1.8||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.01|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||1.8|-1.7|0.96
71940504|NCT02129348|143401959|SUPERIORITY||Treatment Effect Difference|2.2||||0.35|TWO_SIDED|95.0|-2.3|6.6||The threshold for statistical significance was p = 0.05.|Mixed Models Analysis||Cohen's d=0.35|In intent-to-treat analyses, linear mixed effect models (MEM) were used to estimate means of change scores (baseline versus 12 weeks) by treatment group, lithium versus placebo, for continuous outcomes. The MEM method was used to incorporate all time-points of assessment and deal with missing data for participants who did not reach the 12-week time-point.||6.6|-2.3|0.35
71940505|NCT03309956|143402040|SUPERIORITY|||||||0.23|||||||McNemar|||||||0.23
71940506|NCT02768298|143402043|SUPERIORITY||Least Squares (LS) Mean|0.32|STANDARD_ERROR_OF_MEAN|0.268||0.2327|TWO_SIDED|95.0|-0.21|0.85|||ANCOVA|||||0.85|-0.21|0.2327
71940507|NCT02768298|143402044|SUPERIORITY||LS Mean|-0.14|STANDARD_ERROR_OF_MEAN|0.277||0.6247|TWO_SIDED|95.0|-0.68|0.41|||ANCOVA|||||0.41|-0.68|0.6247
71940508|NCT02768298|143402045|SUPERIORITY||LS Mean|-1.23|STANDARD_ERROR_OF_MEAN|0.888||0.1678|TWO_SIDED|95.0|-2.98|0.52|||ANCOVA|||6 weeks||0.52|-2.98|0.1678
71940509|NCT02768298|143402045|SUPERIORITY||LS Mean|0.83|STANDARD_ERROR_OF_MEAN|0.809||0.3052|TWO_SIDED|95.0|-0.77|2.43|||ANCOVA|||3 months||2.43|-0.77|0.3052
71940510|NCT02768298|143402046|SUPERIORITY||LS Mean|0.87|STANDARD_ERROR_OF_MEAN|1.744||0.6181|TWO_SIDED|95.0|-2.58|4.32|||ANCOVA|||6 weeks||4.32|-2.58|0.6181
71940511|NCT02768298|143402046|SUPERIORITY||LS Mean|3.28|STANDARD_ERROR_OF_MEAN|2.124||0.1254|TWO_SIDED|95.0|-0.93|7.48|||ANCOVA|||3 months||7.48|-0.93|0.1254
71940512|NCT02768298|143402047|SUPERIORITY||LS Mean|-0.3|STANDARD_ERROR_OF_MEAN|0.317||0.3432|TWO_SIDED|95.0|-0.93|0.33|||ANCOVA|||Borg value dyspnea||0.33|-0.93|0.3432
71940513|NCT02768298|143402047|SUPERIORITY||LS Mean|0.16|STANDARD_ERROR_OF_MEAN|0.251||0.5319|TWO_SIDED|95.0|-0.34|0.65|||ANCOVA|||Borg value fatigue||0.65|-0.34|0.5319
71940514|NCT04634409|143402048|SUPERIORITY||Odds Ratio (OR)|0.37||||0.009273|TWO_SIDED|95.0|0.18|0.78|||Regression, Logistic|||||0.78|0.18|0.009273
71940515|NCT04634409|143402048|SUPERIORITY||Odds Ratio (OR)|0.32||||0.000271|TWO_SIDED|95.0|0.18|0.59|||Regression, Logistic|||||0.59|0.18|0.000271
71940516|NCT04634409|143402048|SUPERIORITY||Odds Ratio (OR)|0.23||||0.000257|TWO_SIDED|95.0|0.1|0.51|||Regression, Logistic|||||0.51|0.10|0.000257
71940517|NCT04634409|143402048|SUPERIORITY||Odds Ratio (OR)|0.44||||0.013378|TWO_SIDED|95.0|0.23|0.84|||Regression, Logistic|||||0.84|0.23|0.013378
71940518|NCT04634409|143402048|SUPERIORITY||Odds Ratio (OR)|0.24||||0.000318|TWO_SIDED|95.0|0.11|0.52|||Regression, Logistic|||||0.52|0.11|0.000318
71940519|NCT04634409|143402048|SUPERIORITY||Odds Ratio (OR)|0.35||||0.140563|TWO_SIDED|95.0|0.09|1.41|||Regression, Logistic|||||1.41|0.09|0.140563
71940520|NCT04634409|143402049|SUPERIORITY||Odds Ratio (OR)|0.27||||0.000835|TWO_SIDED|95.0|0.12|0.58|||Regression, Logistic|||||0.58|0.12|0.000835
71940521|NCT04634409|143402050|SUPERIORITY||Odds Ratio (OR)|0.56||||0.097231|TWO_SIDED|95.0|0.28|1.11|||Regression, Logistic|||||1.11|0.28|0.097231
71940522|NCT04634409|143402050|SUPERIORITY||Odds Ratio (OR)|0.59||||0.13236|TWO_SIDED|95.0|0.3|1.17|||Regression, Logistic|||||1.17|0.30|0.132360
71940523|NCT04634409|143402056|SUPERIORITY||Odds Ratio (OR)|0.62||||0.769|TWO_SIDED|95.0|0.02|15.57|||Regression, Logistic|||||15.57|0.02|0.769
71940524|NCT04634409|143402056|SUPERIORITY||Odds Ratio (OR)|0.32||||0.494|TWO_SIDED|95.0|0.01|8.12|||Regression, Logistic|||||8.12|0.01|0.494
71940525|NCT04634409|143402056|SUPERIORITY||Odds Ratio (OR)|0.5||||0.671|TWO_SIDED|95.0|0.02|12.51|||Regression, Logistic|||||12.51|0.02|0.671
71940526|NCT04634409|143402056|SUPERIORITY||Odds Ratio (OR)|0.49||||0.663|TWO_SIDED|95.0|0.02|12.27|||Regression, Logistic|||||12.27|0.02|0.663
71940527|NCT04634409|143402056|SUPERIORITY||Odds Ratio (OR)|0.51||||0.68|TWO_SIDED|95.0|0.02|12.76|||Regression, Logistic|||||12.76|0.02|0.680
71940528|NCT04634409|143402056|SUPERIORITY||Odds Ratio (OR)|2.51||||0.584|TWO_SIDED|95.0|0.09|67.88|||Regression, Logistic|||||67.88|0.09|0.584
71940529|NCT04634409|143402058|SUPERIORITY||Odds Ratio (OR)|1.02||||0.979|TWO_SIDED|95.0|0.17|6.06|||Regression, Logistic|||||6.06|0.17|0.979
71940530|NCT04634409|143402058|SUPERIORITY||Odds Ratio (OR)|1.42||||0.675|TWO_SIDED|95.0|0.27|7.39|||Regression, Logistic|||||7.39|0.27|0.675
71940531|NCT04634409|143402061|SUPERIORITY||LSM Difference|-0.67||||0.009|TWO_SIDED|95.0|-1.17|-0.17|||Mixed Models Analysis|||||-0.17|-1.17|0.009
71940532|NCT04634409|143402061|SUPERIORITY||LSM Difference|-0.65||||0.002|TWO_SIDED|95.0|-1.06|-0.24|||Mixed Models Analysis|||||-0.24|-1.06|0.002
71940533|NCT04634409|143402061|SUPERIORITY||LSM Difference|-0.26||||0.263|TWO_SIDED|95.0|-0.72|0.2|||Mixed Models Analysis|||||0.20|-0.72|0.263
71940534|NCT04634409|143402061|SUPERIORITY||LSM Difference|-0.41||||0.083|TWO_SIDED|95.0|-0.87|0.05|||Mixed Models Analysis|||||0.05|-0.87|0.083
71940535|NCT04634409|143402061|SUPERIORITY||LSM Difference|-0.87|||<|0.001|TWO_SIDED|95.0|-1.35|-0.4|||Mixed Models Analysis|||||-0.40|-1.35|<0.001
71940536|NCT04634409|143402061|SUPERIORITY||LSM Difference|-0.64||||0.149|TWO_SIDED|95.0|-1.52|0.23|||Mixed Models Analysis|||||0.23|-1.52|0.149
71940537|NCT04634409|143402062|SUPERIORITY||LSM Difference|-0.82||||0.002|TWO_SIDED|95.0|-1.33|-0.31|||Mixed Models Analysis|||||-0.31|-1.33|0.002
71940538|NCT04634409|143402063|SUPERIORITY||LSM Difference|-0.14||||0.606|TWO_SIDED|95.0|-0.7|0.41|||Mixed Models Analysis|||||0.41|-0.70|0.606
71940539|NCT04634409|143402063|SUPERIORITY||LSM Difference|-0.38||||0.17|TWO_SIDED|95.0|-0.93|0.17|||Mixed Models Analysis|||||0.17|-0.93|0.170
71940540|NCT04634409|143402069|SUPERIORITY||Odds Ratio (OR)|0.96||||0.89|TWO_SIDED|95.0|0.53|1.73|||Regression, Logistic|||||1.73|0.53|0.890
71940541|NCT04634409|143402069|SUPERIORITY||Odds Ratio (OR)|1.43||||0.141|TWO_SIDED|95.0|0.89|2.29|||Regression, Logistic|||||2.29|0.89|0.141
71940542|NCT04634409|143402069|SUPERIORITY||Odds Ratio (OR)|1.15||||0.603|TWO_SIDED|95.0|0.67|1.98|||Regression, Logistic|||||1.98|0.67|0.603
71940543|NCT04634409|143402069|SUPERIORITY||Odds Ratio (OR)|1.69||||0.048|TWO_SIDED|95.0|1.0|2.84|||Regression, Logistic|||||2.84|1.00|0.048
71940544|NCT04634409|143402069|SUPERIORITY||Odds Ratio (OR)|1.19||||0.533|TWO_SIDED|95.0|0.69|2.04|||Regression, Logistic|||||2.04|0.69|0.533
71940545|NCT04634409|143402069|SUPERIORITY||Odds Ratio (OR)|1.09||||0.869|TWO_SIDED|95.0|0.4|2.99|||Regression, Logistic|||||2.99|0.40|0.869
71940546|NCT04634409|143402070|SUPERIORITY||Odds Ratio (OR)|1.31||||0.374|TWO_SIDED|95.0|0.72|2.35|||Regression, Logistic|||||2.35|0.72|0.374
71940547|NCT04634409|143402071|SUPERIORITY||Odds Ratio (OR)|1.87||||0.015|TWO_SIDED|95.0|1.13|3.08|||Regression, Logistic|||||3.08|1.13|0.015
71940548|NCT04634409|143402071|SUPERIORITY||Odds Ratio (OR)|1.29||||0.317|TWO_SIDED|95.0|0.78|2.11|||Regression, Logistic|||||2.11|0.78|0.317
71940549|NCT04634409|143402074|SUPERIORITY||Odds Ratio (OR)|1.62||||0.082|TWO_SIDED|95.0|0.94|2.81|||Regression, Logistic|||||2.81|0.94|0.082
71940550|NCT04634409|143402074|SUPERIORITY||Odds Ratio (OR)|1.86||||0.018|TWO_SIDED|95.0|1.11|3.11|||Regression, Logistic|||||3.11|1.11|0.018
71940551|NCT04634409|143402074|SUPERIORITY||Odds Ratio (OR)|1.71||||0.021|TWO_SIDED|95.0|1.09|2.71|||Regression, Logistic|||||2.71|1.09|0.021
71940552|NCT04634409|143402074|SUPERIORITY||Odds Ratio (OR)|1.93||||0.011|TWO_SIDED|95.0|1.16|3.22|||Regression, Logistic|||||3.22|1.16|0.011
71940553|NCT04634409|143402074|SUPERIORITY||Odds Ratio (OR)|2.17||||0.003|TWO_SIDED|95.0|1.3|3.6|||Regression, Logistic|||||3.60|1.30|0.003
71940554|NCT04634409|143402074|SUPERIORITY||Odds Ratio (OR)|1.34||||0.546|TWO_SIDED|95.0|0.52|3.48|||Regression, Logistic|||||3.48|0.52|0.546
71940555|NCT04634409|143402075|SUPERIORITY||Odds Ratio (OR)|1.04||||0.888|TWO_SIDED|95.0|0.6|1.82|||Regression, Logistic|||||1.82|0.60|0.888
71940556|NCT04634409|143402076|SUPERIORITY||Odds Ratio (OR)|1.88||||0.014|TWO_SIDED|95.0|1.13|3.13|||Regression, Logistic|||||3.13|1.13|0.014
71761131|NCT01039376|143023893|SUPERIORITY||Mean Difference (Final Values)|-1.79||||0.3209|TWO_SIDED|95.0|-5.33|1.75||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Insomnia|||1.75|-5.33|0.3209
71940557|NCT04634409|143402076|SUPERIORITY||Odds Ratio (OR)|1.63||||0.057|TWO_SIDED|95.0|0.98|2.71|||Regression, Logistic|||||2.71|0.98|0.057
71940558|NCT02518685|143402102|SUPERIORITY||Least-Square Mean Difference|6.7|||<|0.0001|TWO_SIDED|95.0|4.54|8.81|||multiple imputations|||||8.81|4.54|<0.0001
71940559|NCT02518685|143402103|SUPERIORITY|Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up|Proportion of Subjects|66.8|||<|0.0001|TWO_SIDED|95.0|59.3|74.3|||Wilson's Midpoint Estimate|||||74.3|59.3|<0.0001
71940560|NCT01611090|143402104|SUPERIORITY||Hazard Ratio (HR)|0.229|||<|0.0001|TWO_SIDED|95.0|0.183|0.286|||Log Rank|||||0.286|0.183|< 0.0001
71940561|NCT00502775|143402134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.2|-0.6||Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.|ANCOVA|No other strata or covariates, other than investigator, were defined.|Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine|The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.||-0.6|-1.2|<0.001
71940562|NCT00502775|143402134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|0.16|<|0.001||95.0|-1.1|-0.4|||ANCOVA||Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo|||-0.4|-1.1|<0.001
71940563|NCT00502775|143402134|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.16||0.374||95.0|-0.2|0.5|||ANCOVA||Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo|||0.5|-0.2|0.374
71940564|NCT00262600|143402154|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.9|||<|0.0001||95.0|0.74|1.1||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 110 mg to warfarin||1.10|0.74|<.0001
71940565|NCT00262600|143402154|NON_INFERIORITY_OR_EQUIVALENCE|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.65|||<|0.0001||95.0|0.52|0.81||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 150 mg to warfarin||0.81|0.52|<.0001
71940566|NCT00262600|143402155|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.2206||95.0|0.83|1.04||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.04|0.83|0.2206
71940567|NCT00262600|143402155|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.0015||95.0|0.74|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.93|0.74|0.0015
71940568|NCT00262600|143402156|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.98||||0.7508||95.0|0.87|1.11||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||1.11|0.87|0.7508
71940569|NCT00262600|143402156|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.0093||95.0|0.74|0.96||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.||||0.96|0.74|0.0093
71940570|NCT00262600|143402157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.0026||95.0|0.7|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||0.93|0.70|0.0026
71940571|NCT00262600|143402157|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.93||||0.3146||95.0|0.81|1.07||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds||1.07|0.81|0.3146
71940572|NCT00262600|143402158|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.3|||<|0.0001||95.0|0.19|0.45||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.45|0.19|<0.0001
71940573|NCT00262600|143402158|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.41|||<|0.0001||95.0|0.28|0.6||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH||0.60|0.28|<0.0001
71940574|NCT00067236|143402197|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.4239|TWO_SIDED|95.0|||||ANOVA|||Changes from baseline in efficacy parameters at Day 90.||||0.4239
71693586|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|5.3||0.9925||95.0|-10.5|10.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.4|-10.5|0.9925
71693587|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|5.02||0.8784||95.0|-9.1|10.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.6|-9.1|0.8784
71693588|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|5.17||0.8948||95.0|-9.5|10.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||10.8|-9.5|0.8948
71693589|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5|STANDARD_ERROR_OF_MEAN|5.26||0.2197||95.0|-3.9|16.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||16.8|-3.9|0.2197
71693590|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5|STANDARD_ERROR_OF_MEAN|5.07||0.6183||95.0|-7.4|12.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.5|-7.4|0.6183
71693591|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1|STANDARD_ERROR_OF_MEAN|5.42||0.4484||95.0|-14.8|6.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.5|-14.8|0.4484
71693592|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4|STANDARD_ERROR_OF_MEAN|5.07||0.3857||95.0|-5.6|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.4|-5.6|0.3857
71940575|NCT02906709|143402222|SUPERIORITY||Difference in the Least Squares Means|-0.9|||<|0.001|TWO_SIDED|95.0|-1.15|-0.66|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior anti-hyperglycemic agent (AHA) therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-0.66|-1.15|<0.001
71940576|NCT02906709|143402223|SUPERIORITY||Difference in % vs. Placebo|7.0|||||TWO_SIDED|95.0|-8.4|21.8|||||||Based on Miettinen \& Nurminen method.|21.8|-8.4|
71693593|NCT00676403|142901936|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8824||95.0|-11.0|9.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-11.0|0.8824
71693594|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|7.87||0.1673||95.0|-4.6|26.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.4|-4.6|0.1673
71940577|NCT02906709|143402225|SUPERIORITY||Difference in % vs. Placebo|-4.1|||||TWO_SIDED|95.0|-12.8|0.4|||||||Based on Miettinen \& Nurminen method.|0.4|-12.8|
71693595|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|7.71||0.9839||95.0|-15.0|15.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||15.3|-15.0|0.9839
71693596|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5|STANDARD_ERROR_OF_MEAN|8.06||0.2905||95.0|-7.3|24.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||24.4|-7.3|0.2905
71761132|NCT01039376|143023894|SUPERIORITY||Mean Difference (Final Values)|0.03||||0.011|TWO_SIDED|95.0|0.01|0.06||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Utility Score|||0.06|0.01|0.0110
71940578|NCT02906709|143402227|SUPERIORITY||Difference in the Least Squares Means|-15.0||||0.002|TWO_SIDED|95.0|-24.5|-5.4|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|-5.4|-24.5|0.002
71940579|NCT02906709|143402228|SUPERIORITY||Percent Between-group Rate Difference|5.8||||0.065|TWO_SIDED|95.0|-0.7|11.5|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|11.5|-0.7|0.065
71940580|NCT02906709|143402229|SUPERIORITY||Percent Between-group Rate Difference|1.6||||0.334|TWO_SIDED|95.0|-4.7|5.8|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen \& Nurminen method.|5.8|-4.7|0.334
71940581|NCT02906709|143402230|SUPERIORITY||Difference in the Least Squares Means|3.1|||<|0.001|TWO_SIDED|95.0|2.3|4.0|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.|4.0|2.3|<0.001
71940582|NCT01124149|143402254|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.61|||<|0.001|TWO_SIDED|95.0|1.76|3.87|||Regression, Logistic|||||3.87|1.76|<0.001
71940583|NCT01124149|143402255|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.1|||<|0.001|TWO_SIDED|95.0|1.44|3.07|||Regression, Logistic|||||3.07|1.44|<0.001
71940584|NCT00977106|143402262|SUPERIORITY_OR_OTHER|||||||0.472|||||||Chi-squared|||||||0.472
71940585|NCT00977106|143402263|SUPERIORITY_OR_OTHER|||||||0.377||||||Between-group test (equal variances)|Student t-test|||Change at Week 1||||0.377
71940586|NCT00977106|143402263|SUPERIORITY_OR_OTHER|||||||0.276|||||||Student t-test|Between-group test (unequal variances)||Change at Week 4||||0.276
71940587|NCT00977106|143402265|SUPERIORITY_OR_OTHER|||||||0.502|||||||Student t-test|Between-group test (equal variances)||Change at Week 4||||0.502
71940588|NCT00977106|143402267|SUPERIORITY_OR_OTHER|||||||0.434||||||Between placebo and TCZ groups test (Equal Variances) at week 4|t-test, 1 sided|||||||0.434
71940589|NCT00977106|143402269|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.692
71940590|NCT00977106|143402269|SUPERIORITY_OR_OTHER|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.019
71940591|NCT00977106|143402270|SUPERIORITY_OR_OTHER|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1||||0.137
71940592|NCT00977106|143402270|SUPERIORITY_OR_OTHER|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4||||0.043
71940593|NCT01644500|143402314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.58|||<|0.001|TWO_SIDED|95.0|-0.76|-0.39|||Mixed Models Analysis|||||-0.39|-0.76|<0.001
71940594|NCT01644500|143402314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.32|||<|0.001|TWO_SIDED|95.0|-0.5|-0.13|||Mixed Models Analysis|||||-0.13|-0.50|<0.001
71940595|NCT01644500|143402315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.7|||<|0.001|TWO_SIDED|5.0|1.8|4.1||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||4.1|1.8|<0.001
71940596|NCT01644500|143402315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|||<|0.001|TWO_SIDED|95.0|1.0|2.3||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact|||||2.3|1.0|<0.001
71940597|NCT01644500|143402315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.9|||<|0.001|TWO_SIDED|95.0|1.8|4.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||4.5|1.8|<0.001
71940598|NCT01644500|143402315|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6||||0.192|TWO_SIDED|95.0|1.1|2.5||Treatment comparison for HbA1c \<7.0%.|Fisher Exact|||||2.5|1.1|0.192
71940599|NCT01644500|143402316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.83|||<|0.001|TWO_SIDED|95.0|-1.15|-0.51|||Mixed Models Analysis|||||-0.51|-1.15|<0.001
71940600|NCT01644500|143402316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.38||||0.022|TWO_SIDED|95.0|-0.7|-0.05|||Mixed Models Analysis|||||-0.05|-0.70|0.022
71940601|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-0.89|-0.45||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||-0.45|-0.89|<0.001
71940602|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.12||||0.304|TWO_SIDED|95.0|-0.34|0.11||Treatment comparison for morning (fasting).|Mixed Models Analysis|||||0.11|-0.34|0.304
71940603|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.36|||<|0.001|TWO_SIDED|95.0|-1.8|-0.92||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.92|-1.80|<0.001
71940604|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.55||||0.015|TWO_SIDED|95.0|-0.99|-0.11||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.11|-0.99|0.015
71940605|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.73|||<|0.001|TWO_SIDED|95.0|-1.1|-0.36||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||-0.36|-1.10|<0.001
71940606|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.06||||0.74|TWO_SIDED|95.0|-0.43|0.31||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis|||||0.31|-0.43|0.740
71940607|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.56|||<|0.001|TWO_SIDED|95.0|-1.99|-1.13||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-1.13|-1.99|<0.001
71940608|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.81|||<|0.001|TWO_SIDED|95.0|-1.24|-0.39||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.39|-1.24|<0.001
71940609|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.67|||<|0.001|TWO_SIDED|95.0|-1.0|-0.34||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||-0.34|-1.00|<0.001
71693597|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6|STANDARD_ERROR_OF_MEAN|7.69||0.5513||95.0|-10.6|19.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.7|-10.6|0.5513
71693598|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1589||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1589
71693599|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.4|STANDARD_ERROR_OF_MEAN|7.95||0.0541||95.0|-0.3|31.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||31.0|-0.3|0.0541
71693600|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.0|STANDARD_ERROR_OF_MEAN|7.66||0.5987||95.0|-11.0|19.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||19.1|-11.0|0.5987
71693601|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|8.1||0.4372||95.0|-9.6|22.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||22.2|-9.6|0.4372
71693602|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|7.71||0.8336||95.0|-16.8|13.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.6|-16.8|0.8336
71940610|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.08||||0.638|TWO_SIDED|95.0|-0.41|0.25||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis|||||0.25|-0.41|0.638
71693603|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.9|STANDARD_ERROR_OF_MEAN|7.9||0.0804||95.0|-1.7|29.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||29.4|-1.7|0.0804
71693604|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.3|STANDARD_ERROR_OF_MEAN|7.94||0.2985||95.0|-7.4|23.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||23.9|-7.4|0.2985
71693605|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2|STANDARD_ERROR_OF_MEAN|7.66||0.4991||95.0|-9.9|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||20.3|-9.9|0.4991
71693606|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|8.15||0.2675||95.0|-7.0|25.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.1|-7.0|0.2675
71940611|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.27|||<|0.001|TWO_SIDED|95.0|-1.68|-0.87||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.87|-1.68|<0.001
71940612|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.45||||0.03|TWO_SIDED|95.0|-0.85|-0.04||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis|||||-0.04|-0.85|0.030
71940613|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-1.19|||<|0.001|TWO_SIDED|95.0|-1.56|-0.82||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.82|-1.56|<0.001
71940614|NCT01644500|143402317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.66|||<|0.001|TWO_SIDED|95.0|-1.03|-0.29||Treatment comparison for bedtime.|Mixed Models Analysis|||||-0.29|-1.03|<0.001
71940615|NCT01644500|143402318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
71940616|NCT01644500|143402318|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model|||||||<0.001
71940617|NCT01644500|143402318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.008
71940618|NCT01644500|143402318|SUPERIORITY_OR_OTHER_LEGACY|||||||0.006||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model|||||||0.006
71940619|NCT01644500|143402319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71940620|NCT01644500|143402319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Fisher Exact|||||||<0.001
71940621|NCT01644500|143402320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|17.41|||<|0.001|TWO_SIDED|95.0|11.27|23.55|||ANCOVA|||Insulin HOMA2-%B||23.55|11.27|<0.001
71940622|NCT01644500|143402320|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|7.92||||0.012|TWO_SIDED|95.0|1.78|14.06|||ANCOVA|||Insulin HOMA2%B||14.06|1.78|0.012
71940623|NCT01644500|143402320|SUPERIORITY||Mean Difference (Net)|16.44|||<|0.001|TWO_SIDED|95.0|11.81|21.06|||ANCOVA|||C-Peptide-Based HOMA2-%B||21.06|11.81|<0.001
71940624|NCT01644500|143402320|SUPERIORITY||Mean Difference (Net)|9.99|||<|0.001|TWO_SIDED|95.0|5.36|14.62|||ANCOVA|||C-Peptide-Based HOMA2-%B||14.62|5.36|<0.001
71940625|NCT01644500|143402321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.34||||0.913|TWO_SIDED|95.0|-5.83|6.51|||ANCOVA|||Insulin-Based HOMA2%S||6.51|-5.83|0.913
71940626|NCT01644500|143402321|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-3.14||||0.318|TWO_SIDED|95.0|-9.3|3.03|||ANCOVA|||Insulin-Based HOMA2%S||3.03|-9.30|0.318
71940627|NCT01644500|143402321|SUPERIORITY||Mean Difference (Net)|-1.39||||0.576|TWO_SIDED|95.0|-6.27|3.49|||ANCOVA|||C-Peptide-Based HOMA2-%S||3.49|-6.27|0.576
71940628|NCT01644500|143402321|SUPERIORITY||Mean Difference (Net)|-6.79||||0.007|TWO_SIDED|95.0|-11.68|-1.89|||ANCOVA|||C-Peptide-Based HOMA2-%S||-1.89|-11.68|0.007
71940629|NCT01644500|143402324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.18||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.180
71940630|NCT01644500|143402324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.245||||||Treatment comparison for SBP.|Mixed Models Analysis|||||||0.245
71940631|NCT01644500|143402324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.717||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.717
71940632|NCT01644500|143402324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.619||||||Treatment comparison for DBP.|Mixed Models Analysis|||||||0.619
71940633|NCT01644500|143402325|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71940634|NCT01644500|143402325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71940635|NCT01644500|143402328|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71940636|NCT01644500|143402328|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71940637|NCT01644500|143402329|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71940638|NCT01644500|143402329|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||||||<0.001
71940639|NCT00721409|143402351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.488||||0.0004|TWO_SIDED|95.0|0.319|0.748||1-sided p-value from the log-rank test stratified by stratification factors per randomization and Part.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Stratified analysis was presented above.||0.748|0.319|0.0004
71940640|NCT00721409|143402351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.572|0.156|<0.0001
71940641|NCT00721409|143402351|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.508||||0.0046|TWO_SIDED|95.0|0.303|0.853||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ\<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.||0.853|0.303|0.0046
71940642|NCT00721409|143402364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.897||||0.2812|TWO_SIDED|95.0|0.623|1.294||1-sided p-value from the log-rank test stratified by Part (α = 0.10).|Log Rank|||Stratified analysis was presented above. Hazard ratio was assuming proportional hazards, a hazard ratio less than 1 indicated a reduction in hazard rate in favor of palbociclib + letrozole.||1.294|0.623|0.2812
71940643|NCT00721409|143402364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.837||||0.2803|TWO_SIDED|95.0|0.458|1.527||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.527|0.458|0.2803
71940644|NCT00721409|143402364|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.935||||0.3875|TWO_SIDED|95.0|0.59|1.48||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.||1.480|0.590|0.3875
71940645|NCT00721409|143402365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.5||||0.1347|TWO_SIDED|95.0|0.76|2.97||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||2.97|0.76|0.1347
71940646|NCT00721409|143402365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.37||||0.0849|TWO_SIDED|95.0|0.74|7.84||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.84|0.74|0.0849
71940647|NCT00721409|143402365|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.14||||0.4515|TWO_SIDED|95.0|0.48|2.76||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||2.76|0.48|0.4515
71940648|NCT00721409|143402366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.93||||0.0471|TWO_SIDED|95.0|0.91|4.08||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||4.08|0.91|0.0471
71940649|NCT00721409|143402366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.34||||0.118|TWO_SIDED|95.0|0.65|8.66||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||8.66|0.65|0.1180
71940650|NCT00721409|143402366|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.72||||0.1631|TWO_SIDED|95.0|0.65|4.54||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||4.54|0.65|0.1631
71940651|NCT00721409|143402368|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.18||||0.0009|TWO_SIDED|95.0|1.48|6.98||1-sided p-value is from the stratified exact test (1-sided, α =0.10).|Cochran-Mantel-Haenszel|||CBR CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio \>1 means better response in favor of palbociclib + letrozole arm.||6.98|1.48|0.0009
71940652|NCT00721409|143402368|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.18||||0.0065|TWO_SIDED|95.0|1.3|13.9||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||13.90|1.30|0.0065
71940653|NCT00721409|143402368|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.55||||0.0442|TWO_SIDED|95.0|0.89|7.7||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.||7.70|0.89|0.0442
71940654|NCT00721409|143402369|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.399|||<|0.0001|TWO_SIDED|95.0|0.265|0.601||1-sided p-value is from the stratified log-rank test (α =0.10).|Log Rank|||Kaplan-Meier method was applied for median and 95% CI. Hazard ratio was based on assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib + letrozole.||0.601|0.265|<0.0001
71940655|NCT00721409|143402369|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.299|||<|0.0001|TWO_SIDED|95.0|0.156|0.572||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.572|0.156|<0.0001
71940656|NCT00721409|143402369|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.486||||0.003|TWO_SIDED|95.0|0.288|0.822||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.||0.822|0.288|0.0030
71940657|NCT00721409|143402370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.7|1.0||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.0|-0.7|0.6900
71940658|NCT00721409|143402370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.7125|TWO_SIDED|95.0|-1.8|1.2||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.2|-1.8|0.7125
71940659|NCT00721409|143402370|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4012|TWO_SIDED|95.0|-0.6|1.5||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.5|-0.6|0.4012
71940660|NCT00721409|143402371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.3346|TWO_SIDED|95.0|-0.5|1.3||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.3|-0.5|0.3346
71940661|NCT00721409|143402371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.563|TWO_SIDED|95.0|-1.0|1.9||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.||1.9|-1.0|0.5630
71940662|NCT00721409|143402371|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.4427|TWO_SIDED|95.0|-0.7|1.6||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.||1.6|-0.7|0.4427
71940663|NCT00048048|143402395|SUPERIORITY_OR_OTHER||Least square mean|0.979|STANDARD_ERROR_OF_MEAN|0.223|||TWO_SIDED|95.0|0.534|1.425|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ Week||1.425|0.534|
71940664|NCT00048048|143402395|SUPERIORITY_OR_OTHER||Least square mean|0.851|STANDARD_ERROR_OF_MEAN|0.228|||TWO_SIDED|95.0|0.395|1.307|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ 2Week||1.307|0.395|
71940665|NCT00048048|143402395|SUPERIORITY_OR_OTHER||Least square mean|0.932|STANDARD_ERROR_OF_MEAN|0.222|||TWO_SIDED|95.0|0.488|1.377|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X /3 Week||1.377|0.488|
71940666|NCT01901055|143402436|SUPERIORITY||Mean Difference (Net)|-0.32|STANDARD_ERROR_OF_MEAN|0.18||0.017|TWO_SIDED|95.0|-0.68|0.04||F-test statistics for group X time = 4.27|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|Statistical analyses were revised from the original protocol for reporting results at 24 week because unable to recruit an adequate sample size at this time point of participants originally on CPAP for 24 weeks and those who were in the original sham-CPAP group who crossed over to CPAP and completed 24 weeks of treatment.||0.04|-0.68|0.017
71940667|NCT01901055|143402437|SUPERIORITY||Mean Difference (Net)|-16.78|STANDARD_ERROR_OF_MEAN|10.99||0.307|TWO_SIDED|95.0|-38.66|5.09||F test statistics for group X time = 1.20|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||5.09|-38.66|0.307
71940668|NCT01901055|143402438|SUPERIORITY||Mean Difference (Net)|-0.25|STANDARD_ERROR_OF_MEAN|0.3||0.732|TWO_SIDED|95.0|-0.85|0.35||F test statistics for group X time = 0.31|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-0.85|0.732
71940669|NCT01901055|143402439|SUPERIORITY||Mean Difference (Net)|3.65|STANDARD_ERROR_OF_MEAN|2.65||0.919|TWO_SIDED|95.0|-1.62|8.92||F test statistics for group X time = 0.01|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||8.92|-1.62|0.919
71940670|NCT01901055|143402440|SUPERIORITY||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|0.54||0.125|TWO_SIDED|95.0|-1.18|0.96||F-test statistics for group X time = 2.12|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.96|-1.18|0.125
71940671|NCT01901055|143402441|SUPERIORITY||Mean Difference (Net)|87.22|STANDARD_ERROR_OF_MEAN|529.1||0.639|TWO_SIDED|95.0|-936.1|1137.5||F-test statistics for group X time = 0.45|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1137.50|-936.10|0.639
71940672|NCT01901055|143402442|SUPERIORITY||Mean Difference (Net)|-0.63|STANDARD_ERROR_OF_MEAN|0.49||0.461|TWO_SIDED|95.0|-1.61|0.35||F-test statistics for group X time = 0.78|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||0.35|-1.61|0.461
71940673|NCT01901055|143402443|SUPERIORITY||Mean Difference (Net)|3.04|STANDARD_ERROR_OF_MEAN|3.94||0.776|TWO_SIDED|95.0|-4.78|10.86||F-test statistics for group X time= 0.25|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||10.86|-4.78|0.776
71940674|NCT01901055|143402444|SUPERIORITY||Mean Difference (Net)|0.33|STANDARD_ERROR_OF_MEAN|0.79||0.378|TWO_SIDED|95.0|-1.24|1.89||F-test statistics for group X time = 0.98|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.89|-1.24|0.378
71940675|NCT01901055|143402445|SUPERIORITY||Mean Difference (Net)|3.18|STANDARD_ERROR_OF_MEAN|7.24||0.213|TWO_SIDED|95.0|-11.19|17.56||F-test statistics for group X time = 1.57|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||17.56|-11.19|0.213
71940676|NCT01901055|143402446|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.64||0.005|TWO_SIDED|95.0|-1.27|1.28||F-test statistics for group X time = 5.66|Mixed Models Analysis||Treatment Difference = Active CPAP - Sham CPAP|||1.28|-1.27|0.005
71940677|NCT00449150|143402507|SUPERIORITY_OR_OTHER||LS means estimate|-0.198||||0.7424|TWO_SIDED|95.0|-1.38|0.98|||ANOVA|||||0.98|-1.38|0.7424
71940678|NCT00449150|143402507|SUPERIORITY_OR_OTHER||LS means estimate|0.055||||0.926||95.0|-1.1|1.21|||ANOVA|||||1.21|-1.10|0.926
71940679|NCT00449150|143402507|SUPERIORITY_OR_OTHER||LS means estimate|-0.252||||0.6699||95.0|-1.41|0.91|||ANOVA|||||0.91|-1.41|0.6699
71940680|NCT03312257|143402509|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|0.03||||0.7|TWO_SIDED|95.0|-0.14|0.21|||Repeated measures analyses|||||0.21|-0.14|0.70
71940681|NCT03312257|143402510|OTHER|Repeated measures analyses using mixed linear models in STATA (version 15) were undertaken to model myopia progression (primary outcome) and axial elongation (secondary outcome) to account for the clusters of correlated data due to repeated participant outcome measures.|Mean Difference (Final Values)|-0.08||||0.054|TWO_SIDED|95.0|-0.16|0.002|||Repeated measures analyses|||||0.002|-0.16|0.054
71940682|NCT01345019|143402529|NON_INFERIORITY|A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR \[95% CI\] of 1.48 \[1.28, 1.71\] for placebo vs zoledronic acid.|Hazard Ratio (HR)|0.98||||0.01|TWO_SIDED|95.0|0.85|1.14|||Cox proportional hazards model|Based on a Cox proportional hazards model stratified by the randomization stratification factors.|A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab|||1.14|0.85|0.010
71940683|NCT01345019|143402532|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.||||||0.82|||||||Log Rank|Based on a log rank test stratified by randomization stratification factors.||||||0.82
71940684|NCT01345019|143402533|SUPERIORITY|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE \[superiority\] and time to first and subsequent on study SRE \[superiority, multiple event analysis\]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.|Rate ratio|1.01||||0.84|TWO_SIDED|95.0|0.89|1.15|||Andersen-Gill model|Based on an Andersen-Gill model stratified by the randomization stratification factors.|A rate ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|||1.15|0.89|0.84
71940685|NCT01345019|143402535|SUPERIORITY|If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.|Hazard Ratio (HR)|0.9||||0.41|TWO_SIDED|95.0|0.7|1.16|||Cox proportional hazards model||A hazard ratio (denosumab:zoledronic acid) \< 1 favors denosumab.|The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.||1.16|0.70|0.41
71940686|NCT00235456|143402537|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.61||||0.04|TWO_SIDED|95.0|0.38|0.98|||Chi-squared|||||0.98|0.38|0.04
71940687|NCT00235456|143402538|SUPERIORITY_OR_OTHER|||||||0.54|||||||t-test, 2 sided|||||||0.54
71940688|NCT00235456|143402539|SUPERIORITY_OR_OTHER|||||||0.28|||||||t-test, 2 sided|||||||0.28
71940689|NCT00235456|143402540|SUPERIORITY_OR_OTHER|||||||0.57|||||||t-test, 2 sided|||||||0.57
71940690|NCT00235456|143402541|SUPERIORITY_OR_OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71940691|NCT00235456|143402542|SUPERIORITY_OR_OTHER|||||||0.09|||||||t-test, 2 sided|||||||0.09
71940692|NCT02933866|143402552|SUPERIORITY|||||||0.2961|||||||Cochran-Mantel-Haenszel|||||||0.2961
71940693|NCT04646109|143402565|SUPERIORITY|||||||0.43||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.43
71940694|NCT04646109|143402566|SUPERIORITY|||||||0.14||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.14
71940695|NCT04646109|143402567|SUPERIORITY|||||||0.68||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.68
71940696|NCT04646109|143402568|SUPERIORITY|||||||0.15||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.15
71940697|NCT04646109|143402569|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.37
71940698|NCT04646109|143402570|SUPERIORITY|||||||0.12||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.12
71940699|NCT04646109|143402571|SUPERIORITY|||||||0.22||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.22
71940700|NCT04646109|143402574|SUPERIORITY|||||||0.1||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.10
71940701|NCT04646109|143402575|SUPERIORITY|||||||0.37||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.37
71940702|NCT04646109|143402576|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
71940703|NCT04646109|143402577|SUPERIORITY|||||||0.39||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.39
71940704|NCT04646109|143402578|SUPERIORITY|||||||0.24||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.24
71940705|NCT04646109|143402579|SUPERIORITY|||||||0.56||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.56
71940706|NCT04646109|143402580|SUPERIORITY|||||||0.005||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.005
71940707|NCT04646109|143402581|SUPERIORITY|||||||0.03||||||A p\<0.05 value was considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.03
71940708|NCT04646109|143402582|SUPERIORITY|||||||0.01||||||A p\<0.05 value was considered statistically significant|Chi-squared|||||||0.01
71940709|NCT00577460|143402585|SUPERIORITY_OR_OTHER|||||||0.0039||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX ER versus Placebo||||0.0039
71940710|NCT00577460|143402585|SUPERIORITY_OR_OTHER|||||||0.0001||95.0|||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX IR versus Placebo||||0.0001
71940711|NCT00577460|143402588|SUPERIORITY_OR_OTHER|||||||0.559||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5590
71940712|NCT00577460|143402588|SUPERIORITY_OR_OTHER|||||||0.1289||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1289
71940713|NCT00577460|143402590|SUPERIORITY_OR_OTHER|||||||0.1073||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1073
71940714|NCT00577460|143402590|SUPERIORITY_OR_OTHER|||||||0.8694||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8694
71940715|NCT00577460|143402591|SUPERIORITY_OR_OTHER|||||||0.0009||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0009
71940716|NCT00577460|143402591|SUPERIORITY_OR_OTHER|||||||0.0573||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0573
71940717|NCT00577460|143402592|SUPERIORITY_OR_OTHER|||||||0.6434||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.6434
71940718|NCT00577460|143402592|SUPERIORITY_OR_OTHER|||||||0.2469||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.2469
71940719|NCT00577460|143402593|SUPERIORITY_OR_OTHER|||||||0.9741||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.9741
71940720|NCT00577460|143402593|SUPERIORITY_OR_OTHER|||||||0.762||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.7620
71940721|NCT00577460|143402597|SUPERIORITY_OR_OTHER|||||||0.0831||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0831
71940722|NCT00577460|143402597|SUPERIORITY_OR_OTHER|||||||0.0759||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0759
71940723|NCT00577460|143402598|SUPERIORITY_OR_OTHER|||||||0.1713||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.1713
71940724|NCT00577460|143402598|SUPERIORITY_OR_OTHER|||||||0.013||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0130
71940725|NCT00577460|143402599|SUPERIORITY_OR_OTHER|||||||0.0015||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0015
71940726|NCT00577460|143402599|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0002
71940727|NCT00577460|143402600|SUPERIORITY_OR_OTHER|||||||0.876||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.8760
71940728|NCT00577460|143402600|SUPERIORITY_OR_OTHER|||||||0.5113||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.5113
71940729|NCT00577460|143402601|SUPERIORITY_OR_OTHER|||||||0.0148||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0148
71940730|NCT00577460|143402601|SUPERIORITY_OR_OTHER|||||||0.0201||95.0|||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate||||||0.0201
71940731|NCT00159965|143402645|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.673|STANDARD_ERROR_OF_MEAN|0.369||0.29|TWO_SIDED|95.0|-0.051|1.396|||Overdispersed Poisson Regression|||Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||1.396|-0.051|0.29
71940732|NCT00159965|143402645|SUPERIORITY_OR_OTHER||Risk Ratio, log|-0.598|STANDARD_ERROR_OF_MEAN|0.276||0.03|TWO_SIDED|95.0|-1.139|-0.073|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.||-0.073|-1.139|0.03
71940733|NCT00159965|143402645|SUPERIORITY_OR_OTHER||Risk Ratio, log|0.077|STANDARD_ERROR_OF_MEAN|0.252||0.78|TWO_SIDED|95.0|-0.431|0.571|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.||0.571|-0.431|0.78
71940734|NCT00159965|143402646|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940735|NCT00159965|143402647|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940736|NCT00159965|143402648|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940737|NCT00159965|143402649|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940738|NCT00159965|143402650|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940739|NCT00159965|143402651|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940740|NCT00159965|143402652|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940741|NCT00159965|143402653|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940742|NCT00159965|143402654|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940743|NCT00159965|143402655|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940744|NCT00159965|143402656|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940745|NCT00159965|143402657|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940746|NCT00159965|143402658|SUPERIORITY_OR_OTHER||||||>|0.05||95.0|||||ANCOVA|||||||>0.05
71940747|NCT02841709|143402716|OTHER||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose response across placebo and all ACT-541468 doses. The null hypothesis of no dose response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value \<0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"||||<0.001
71940748|NCT02841709|143402716|OTHER||LS mean difference|-5.4|STANDARD_ERROR_OF_MEAN|4.73||0.258|TWO_SIDED|95.0|-14.7|4.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||4.0|-14.7|0.258
71940749|NCT02841709|143402716|OTHER||LS mean difference|-18.4|STANDARD_ERROR_OF_MEAN|4.76|<|0.001|TWO_SIDED|95.0|-27.8|-9.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean|||-9.0|-27.8|<0.001
71940750|NCT02841709|143402716|OTHER||LS mean difference|-31.5|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-40.9|-22.2|||Linear mixed effects model|||||-22.2|-40.9|<0.001
71940751|NCT02841709|143402716|OTHER||LS mean difference|-47.8|STANDARD_ERROR_OF_MEAN|4.74|<|0.001|TWO_SIDED|95.0|-57.2|-38.5|||Linear mixed effects model|||||-38.5|-57.2|<0.001
71940752|NCT00076102|143402725|OTHER|||||||0.0301||||||The reported F statistic and p-value are representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Adaptive Behavior.|ANOVA|||F=5.45 under the null hypothesis||||0.0301
71940753|NCT00076102|143402725|OTHER|||||||0.0186||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Emotional Functioning.|ANOVA|||F = 6.56 under the null hypothesis||||0.0186
71940754|NCT00076102|143402725|OTHER|||||||0.0032||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Medical/Physical Status.|ANOVA|||F=11.23 under the null hypothesis||||0.0032
71940755|NCT00076102|143402726|OTHER|||||||0.6263|||||||ANOVA|||F=0.25 under the null hypothesis||||0.6263
71940756|NCT00076102|143402726|OTHER|||||||0.3625|||||||ANOVA|||F= 0.87 under the null hypothesis||||0.3625
71940757|NCT00076102|143402726|OTHER|||||||0.5877|||||||ANOVA|||F=0.31 under the null hypothesis||||0.5877
71940758|NCT00076102|143402726|OTHER|||||||0.2767|||||||ANOVA|||F=1.27 under the null hypothesis||||0.2767
71940759|NCT00076102|143402726|OTHER|||||||0.8466|||||||ANOVA|||F=0.04 under the null hypothesis||||0.8466
71940760|NCT00076102|143402726|OTHER|||||||0.6774|||||||ANOVA|||F=0.18 under the null hypothesis||||0.6774
71940761|NCT01210001|143402731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.69|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.27|-0.69|<0.0001
71940762|NCT01210001|143402731|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|STANDARD_ERROR_OF_MEAN|0.09|<|0.0001|TWO_SIDED|97.5|-0.82|-0.4||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.40|-0.82|<0.0001
71940763|NCT01210001|143402732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-23.48|STANDARD_ERROR_OF_MEAN|3.71|<|0.0001|TWO_SIDED|97.5|-31.81|-15.15||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo|||-15.15|-31.81|<0.0001
71940764|NCT01210001|143402732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.46|STANDARD_ERROR_OF_MEAN|3.68|<|0.0001|TWO_SIDED|97.5|-36.73|-20.19||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo|||-20.19|-36.73|<0.0001
71940765|NCT01210001|143402733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.64|-1.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo|||-1.27|-2.64|<0.0001
71940766|NCT01210001|143402733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.81|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001|TWO_SIDED|97.5|-2.49|-1.13||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 25mg minus placebo|||-1.13|-2.49|<0.0001
71940767|NCT01210001|143402734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.69|-0.21||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo|||-0.21|-0.69|<0.0001
71940768|NCT01210001|143402734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|97.5|-0.83|-0.36||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo|||-0.36|-0.83|<0.0001
71940769|NCT01739790|143402741|OTHER|||||||0.45|||||||Fisher Exact|||||||0.45
71940770|NCT02581345|143402742|EQUIVALENCE|Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|90.0|-0.043|0.072||||||||0.072|-0.043|
71940771|NCT02581345|143402742|EQUIVALENCE|Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%|Difference in proportion (M923 - EU RPP)|0.014|||||TWO_SIDED|95.0|-0.054|0.082||||||||0.082|-0.054|
71940772|NCT02581345|143402743|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.|Difference in proportion (M923 - EU RPP)|0.031|||||TWO_SIDED|95.0|-0.048|0.11||||||||0.110|-0.048|
71940773|NCT02581345|143402744|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|90.0|-0.061|0.016||||||||0.016|-0.061|
71940774|NCT02581345|143402744|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||TWO_SIDED|95.0|-0.069|0.024||||||||0.024|-0.069|
71940775|NCT02581345|143402747|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: \[-0.18;+0.18\] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|90.0|0.01|0.149||||||||0.149|0.010|
71940776|NCT02581345|143402747|OTHER|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:\[-0.15;+0.15\] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||TWO_SIDED|95.0|-0.004|0.162||||||||0.162|-0.004|
71940777|NCT02122796|143402779|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
71940778|NCT02122796|143402780|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
71940779|NCT02122796|143402782|SUPERIORITY_OR_OTHER||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student's t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student's t tests.||||||<0.01
71940780|NCT01244126|143402791|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA by ranks|0.21|STANDARD_DEVIATION|3.0||0.21|TWO_SIDED|95.0|||||Kruskal-Wallis|||The primary outcome of the study was the maximum postoperative FLACC pain score.||||0.21
71940781|NCT01244126|143402792|SUPERIORITY_OR_OTHER||Kruskall Wallis ANOVA|0.34||||0.34||95.0|||||Kruskal-Wallis|||Kruskall Wallis test||||0.34
71940782|NCT00863746|143402796|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.9934||||0.4687|TWO_SIDED|95.0|0.8409|1.1735||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||1.1735|0.8409|0.4687
71940783|NCT00863746|143402797|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6068|||<|0.0001|TWO_SIDED|95.0|0.5139|0.7165||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.7165|0.5139|<0.0001
71940784|NCT00863746|143402798|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.2263|||<|1e-06|TWO_SIDED|95.0|0.1575|0.2952|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.2952|0.1575|<0.000001
71940785|NCT00863746|143402799|SUPERIORITY_OR_OTHER||CMH-adjusted difference in proportions|0.039||||0.000876|TWO_SIDED|95.0|0.0137|0.0642|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||||0.0642|0.0137|0.000876
71940786|NCT00863746|143402800|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.542|||<|0.0001|TWO_SIDED|95.0|0.4526|0.6492||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo||0.6492|0.4526|<0.0001
71940787|NCT00863746|143402801|SUPERIORITY_OR_OTHER|||||||0.3121||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.3121
71940788|NCT00863746|143402802|SUPERIORITY_OR_OTHER|||||||0.2948||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.2948
71940789|NCT00863746|143402803|SUPERIORITY_OR_OTHER|||||||0.8344||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis|||||||0.8344
71940790|NCT00863746|143402804|SUPERIORITY_OR_OTHER|||||||0.1438||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis|||||||0.1438
71940791|NCT00863746|143402805|SUPERIORITY_OR_OTHER|||||||0.9228||||||p-value for treatment effect equal to 0.|Mixed Models Analysis|||||||0.9228
71940792|NCT00862979|143402809|SUPERIORITY||Mean Difference (Net)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||||-6.1|-16.5|<.0001
71940793|NCT00862979|143402810|OTHER|difference||||||0.203|||||||Fisher Exact|||Month 6 to Month 9||||0.203
71940794|NCT00862979|143402810|OTHER|difference||||||0.002|||||||Fisher Exact|||Month 9 to Month 18||||0.002
71940795|NCT00862979|143402812|SUPERIORITY||Mean Difference (Final Values)|-14.0|||<|0.0001|TWO_SIDED|95.0|-19.6|-8.3|||ANCOVA|||Month 12||-8.3|-19.6|<.0001
71940796|NCT00862979|143402812|SUPERIORITY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.5|-6.1|||ANCOVA|||Month 18||-6.1|-16.5|<.0001
71940797|NCT00862979|143402814|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||||||0.008
71940798|NCT01545076|143402826|SUPERIORITY||Difference in Percent|-24.6|||=|0.007|TWO_SIDED|95.0|-40.7|-6.21|||Fisher Exact|||||-6.21|-40.7|=0.007
71940799|NCT01545076|143402826|SUPERIORITY||Difference in Percent|-30.4|||<|0.001|TWO_SIDED|95.0|-46.0|-12.2|||Fisher Exact|||||-12.2|-46.0|<0.001
71940800|NCT01545076|143402827|OTHER||Median Difference (Net)|0.0|||=|0.005|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|=0.005
71940801|NCT01545076|143402827|OTHER||Median Difference (Net)|-1.0|||<|0.001|TWO_SIDED|95.0|-1.0|0.0|||Wilcoxon rank sum|||||0|-1|<0.001
71940802|NCT01545076|143402828|OTHER||Median Difference (Net)|7.6|||=|0.004|TWO_SIDED|95.0|2.0|14.0|||Wilcoxon rank sum|||||14|2|=0.004
71940803|NCT01545076|143402828|OTHER||Median Difference (Net)|5.7|||=|0.014|TWO_SIDED|95.0|0.7|11.7|||Wilcoxon rank sum|||||11.7|0.7|=0.014
71940804|NCT01545076|143402829|OTHER||Median Difference (Final Values)|2.0|||=|0.003|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.003
71940805|NCT01545076|143402829|OTHER||Median Difference (Final Values)|2.0|||=|0.002|TWO_SIDED|95.0|1.0|4.0|||Wilcoxon rank sum|||||4|1|=0.002
71940806|NCT01545076|143402830|OTHER||Median Difference (Net)|3.0|||=|0.03|TWO_SIDED|95.0|0.0|9.0|||Wilcoxon rank sum|||||9|0|=0.03
71940807|NCT01545076|143402830|OTHER||Median Difference (Net)|5.0|||<|0.001|TWO_SIDED|95.0|2.0|9.0|||Wilcoxon rank sum|||||9|2|<0.001
71940808|NCT02252562|143402857|EQUIVALENCE|We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.|Odds Ratio (OR)|1.07|||||TWO_SIDED|95.0|0.82|1.4|||fixed effects univariable analysis|||||1.40|0.82|
71940809|NCT04084483|143402924|SUPERIORITY|||||||0.2175|||||||ANCOVA|||||||0.2175
71940810|NCT04084483|143402925|SUPERIORITY|||||||0.3852|||||||ANCOVA|||||||0.3852
71940811|NCT04084483|143402926|SUPERIORITY|||||||0.298|||||||ANCOVA|||||||0.2980
71940812|NCT04084483|143402927|SUPERIORITY|||||||0.0634|||||||ANCOVA|||||||0.0634
71940813|NCT04084483|143402928|SUPERIORITY|||||||0.7388|||||||ANCOVA|||Corneal Sum||||0.7388
71940814|NCT04084483|143402928|SUPERIORITY|||||||0.3717|||||||ANCOVA|||Corneal Sum||||0.3717
71940815|NCT04084483|143402928|SUPERIORITY|||||||0.3164|||||||ANCOVA|||Conjunctival Sum||||0.3164
71940816|NCT04084483|143402928|SUPERIORITY|||||||0.1953|||||||ANCOVA|||Conjunctival Sum||||0.1953
71940817|NCT04084483|143402928|SUPERIORITY|||||||0.4645|||||||ANCOVA|||Total Eye Sum||||0.4645
71940818|NCT04084483|143402928|SUPERIORITY|||||||0.2135|||||||ANCOVA|||Total Eye Sum||||0.2135
71940819|NCT04084483|143402929|SUPERIORITY|||||||0.599|||||||ANCOVA|||||||0.5990
71940820|NCT04084483|143402929|SUPERIORITY|||||||0.2122|||||||ANCOVA|||||||0.2122
71940821|NCT04084483|143402930|SUPERIORITY|||||||0.9146|||||||ANCOVA|||||||0.9146
71940822|NCT04084483|143402930|SUPERIORITY|||||||0.8494|||||||ANCOVA|||||||0.8494
71940823|NCT04084483|143402931|SUPERIORITY|||||||0.4747|||||||ANCOVA|||||||0.4747
71940824|NCT04084483|143402931|SUPERIORITY|||||||0.5619|||||||ANCOVA|||||||0.5619
71940825|NCT04084483|143402932|SUPERIORITY|||||||0.5985|||||||ANCOVA|||||||0.5985
71940826|NCT04084483|143402932|SUPERIORITY|||||||0.7626|||||||ANCOVA|||||||0.7626
71940827|NCT04084483|143402933|SUPERIORITY|||||||0.833|||||||ANCOVA|||||||0.8330
71940828|NCT04084483|143402933|SUPERIORITY|||||||0.2777|||||||ANCOVA|||||||0.2777
71940829|NCT04084483|143402934|SUPERIORITY|||||||0.9829|||||||ANCOVA|||||||0.9829
71940830|NCT04084483|143402934|SUPERIORITY|||||||0.8675|||||||ANCOVA|||||||0.8675
71940831|NCT04084483|143402935|SUPERIORITY|||||||0.5836|||||||ANCOVA|||||||0.5836
71940832|NCT04084483|143402935|SUPERIORITY|||||||0.2352|||||||ANCOVA|||||||0.2352
71940833|NCT04084483|143402936|SUPERIORITY|||||||0.7367|||||||ANCOVA|||Ocular Discomfort||||0.7367
71940834|NCT04084483|143402936|SUPERIORITY|||||||0.3865|||||||ANCOVA|||Ocular Discomfort||||0.3865
71940835|NCT04084483|143402936|SUPERIORITY|||||||0.8796|||||||ANCOVA|||Burning||||0.8796
71940836|NCT04084483|143402936|SUPERIORITY|||||||0.3515|||||||ANCOVA|||Burning||||0.3515
71940837|NCT04084483|143402936|SUPERIORITY|||||||0.6338|||||||ANCOVA|||Dryness||||0.6338
71940838|NCT04084483|143402936|SUPERIORITY|||||||0.4685|||||||ANCOVA|||Dryness||||0.4685
71940839|NCT04084483|143402936|SUPERIORITY|||||||0.4757|||||||ANCOVA|||Grittiness||||0.4757
71940840|NCT04084483|143402936|SUPERIORITY|||||||0.8803|||||||ANCOVA|||Grittiness||||0.8803
71940841|NCT04084483|143402936|SUPERIORITY|||||||0.8529|||||||ANCOVA|||Stinging||||0.8529
71940842|NCT04084483|143402936|SUPERIORITY|||||||0.7713|||||||ANCOVA|||Stinging||||0.7713
71940843|NCT04084483|143402937|SUPERIORITY|||||||0.138|||||||ANCOVA|||Burning/Stinging||||0.1380
71940844|NCT04084483|143402937|SUPERIORITY|||||||0.3334|||||||ANCOVA|||Burning/Stinging||||0.3334
71940845|NCT04084483|143402937|SUPERIORITY|||||||0.1008|||||||ANCOVA|||Itching||||0.1008
71940846|NCT04084483|143402937|SUPERIORITY|||||||0.4582|||||||ANCOVA|||Itching||||0.4582
71940847|NCT04084483|143402937|SUPERIORITY|||||||0.1511|||||||ANCOVA|||Foreign Body Sensation||||0.1511
71940848|NCT04084483|143402937|SUPERIORITY|||||||0.2555|||||||ANCOVA|||Foreign Body Sensation||||0.2555
71940849|NCT04084483|143402937|SUPERIORITY|||||||0.1546|||||||ANCOVA|||Blurry Vision||||0.1546
71940850|NCT04084483|143402937|SUPERIORITY|||||||0.0495|||||||ANCOVA|||Blurry Vision||||0.0495
71693607|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|7.77||0.1593||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-4.3|0.1593
71693608|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|18.9|STANDARD_ERROR_OF_MEAN|7.96||0.0179||95.0|3.3|34.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||34.6|3.3|0.0179
71693609|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|17.8|STANDARD_ERROR_OF_MEAN|8.06||0.0281||95.0|1.9|33.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||33.7|1.9|0.0281
71693610|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.3|STANDARD_ERROR_OF_MEAN|7.77||0.1883||95.0|-5.0|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||25.5|-5.0|0.1883
71693611|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0|STANDARD_ERROR_OF_MEAN|8.28||0.23||95.0|-6.3|26.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||26.3|-6.3|0.2300
71693612|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.4|STANDARD_ERROR_OF_MEAN|7.82||0.7575||95.0|-13.0|17.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||17.8|-13.0|0.7575
71693613|NCT00676403|142901937|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.3|STANDARD_ERROR_OF_MEAN|8.02||0.0757||95.0|-1.5|30.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||30.1|-1.5|0.0757
71693614|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.89||0.2817||95.0|-18.0|5.2|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-18.0|0.2817
71940851|NCT04084483|143402937|SUPERIORITY|||||||0.5791|||||||ANCOVA|||Eye Dryness||||0.5791
71940852|NCT04084483|143402937|SUPERIORITY|||||||0.0736|||||||ANCOVA|||Eye Dryness||||0.0736
71940853|NCT04084483|143402937|SUPERIORITY|||||||0.3666|||||||ANCOVA|||Photophobia||||0.3666
71940854|NCT04084483|143402937|SUPERIORITY|||||||0.039|||||||ANCOVA|||Photophobia||||0.0390
71693615|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.76||0.6796||95.0|-13.7|9.0|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.0|-13.7|0.6796
71693616|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|6.01||0.2505||95.0|-18.8|4.9|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.9|-18.8|0.2505
71693617|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.73||0.5102||95.0|-15.1|7.5|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.5|-15.1|0.5102
71940855|NCT04084483|143402937|SUPERIORITY|||||||0.0655|||||||ANCOVA|||Pain||||0.0655
71940856|NCT04084483|143402937|SUPERIORITY|||||||0.1947|||||||ANCOVA|||Pain||||0.1947
71940857|NCT04084483|143402938|SUPERIORITY|||||||0.9274|||||||ANCOVA|||||||0.9274
71940858|NCT04084483|143402938|SUPERIORITY|||||||0.0888|||||||ANCOVA|||||||0.0888
71940859|NCT02194998|143402948|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR12 rate \<= 70%.||||<0.01
71940860|NCT02194998|143402948|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR12 rate \<= 70%.||||0.47
71940861|NCT02194998|143402948|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR12 rate \<= 70%.||||<0.01
71940862|NCT02194998|143402948|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR12 rate \<= 70%.||||0.24
71940863|NCT02194998|143402961|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR24 rate \<= 70%.||||<0.01
71940864|NCT02194998|143402961|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR24 rate \<= 70%.||||0.47
71940865|NCT02194998|143402961|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR24 rate \<= 70%.||||<0.01
71940866|NCT02194998|143402961|SUPERIORITY|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR24 rate \<= 70%.||||0.24
71940867|NCT01458405|143402963|SUPERIORITY|||||||0.6453||||||Repeated measures multivariable linear regression with Baseline as a covariate and unstructured covariance.|Regression, Linear|||||||0.6453
71940868|NCT01890915|143403045|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED||||||ANOVA|||"Due to impaired thermoregulatory mechanisms secondary to spinal cord injury, subjects with tetraplegia were hypothesized to have a significant rise in core temperature after exposure to warm ambient temperatures, while control subjects were hypothesized to maintain constant core temperature.~Percent change in core temperature of subjects in each group were compared to determine if they were significantly different from baseline to warm exposure."||||0.0001
71940869|NCT01890915|143403046|SUPERIORITY_OR_OTHER|||||||0.006|TWO_SIDED||||||ANOVA|||We hypothesized that subjects with tetraplegia would demonstrate a change in cognitive performance after heat exposure if they had demonstrated a significant increase in core body temperature - as was hypothesized in our primary hypothesis. Cognitive performance was measured, in part, by Interference T-scores derived from the Stroop Color and Word Test.||||0.006
71940870|NCT01890915|143403047|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED||||||ANOVA|||Due to impaired thermoregulatory mechanisms, subjects with tetraplegia were hypothesized to have diminished increases in sweat rate in comparison to controls after heat exposure.||||0.015
71940871|NCT03552757|143403056|SUPERIORITY||Treatment difference|-6.21|||<|0.0001|TWO_SIDED|95.0|-7.28|-5.15|||ANCOVA|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using an analysis of covariance model (ANCOVA) with randomised treatment, stratification groups (oral anti-diabetic (OAD) treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||-5.15|-7.28|<0.0001
71940872|NCT03552757|143403056|SUPERIORITY||Treatment difference|-7.57|||<|0.0001|TWO_SIDED|95.0|-8.56|-6.58|||MMRM|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements (MMRM) with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||-6.58|-8.56|<0.0001
71940873|NCT03552757|143403057|SUPERIORITY||Odds Ratio (OR)|4.88|||<|0.0001|TWO_SIDED|95.0|3.58|6.64|||Regression, Logistic|||Results are based on the data from in-trial observation period. Week 68 responses were analysed using a binary logistic regression model with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate.||6.64|3.58|<0.0001
71940874|NCT03552757|143403057|SUPERIORITY||Odds Ratio (OR)|8.69|||<|0.0001|TWO_SIDED|95.0|6.31|11.97|||Regression, Logistic|||Results are based on the data from on-treatment observation period. All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a MMRM with randomised treatment, stratification groups (OAD treatment status and HbA1c category at screening) and the interaction between stratification groups as factors and baseline body weight as covariate, all nested within visit.||11.97|6.31|<0.0001
71940875|NCT02674334|143403098|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|0.83||0.165|TWO_SIDED|95.0|-0.49|2.82||P-values were not adjusted for multiple inferences|ANOVA|Continuous responses were tested using RCB ANOVA.||||2.82|-.49|0.165
71940876|NCT02660242|143403100|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.||The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose \<70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery \[prior to the meal\]), the nadir glucose value was carried forward through the end of early recovery.||||<0.001
71940877|NCT02660242|143403101|OTHER|||||||0.99|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.99
71940878|NCT02660242|143403102|SUPERIORITY|||||||0.15|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose||||||0.15
71940879|NCT02660242|143403103|SUPERIORITY|||||||0.99|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.99
71940880|NCT02660242|143403104|SUPERIORITY|||||||0.43|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.43
71940881|NCT02660242|143403105|SUPERIORITY|||||||0.16|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.16
71940882|NCT02660242|143403106|SUPERIORITY|||||||0.69|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.69
71940883|NCT02660242|143403107|SUPERIORITY|||||||0.67|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.67
71940884|NCT02660242|143403108|SUPERIORITY|||||||0.84|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.84
71940885|NCT02660242|143403109|SUPERIORITY|||||||0.63|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.63
71940886|NCT02660242|143403110|SUPERIORITY|||||||0.24|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.24
71940887|NCT02660242|143403111|SUPERIORITY|||||||0.26|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session||||||0.26
71940888|NCT00982553|143403112|SUPERIORITY||Geometric mean ratios|0.79|||||TWO_SIDED|95.0|0.62|1.0||||||||1.00|0.62|
71940889|NCT00982553|143403113|SUPERIORITY||Geometric mean ratios|1.16|||||TWO_SIDED|95.0|0.73|1.86||||||||1.86|0.73|
71940890|NCT00982553|143403114|SUPERIORITY||Geometric mean ratios|1.01|||||TWO_SIDED|95.0|0.87|1.18||||||||1.18|0.87|
71940891|NCT00982553|143403115|SUPERIORITY||Geometric mean ratios|0.82|||||TWO_SIDED|95.0|0.36|1.85||||||||1.85|0.36|
71940892|NCT00386009|143403118|SUPERIORITY_OR_OTHER|||||||0.068||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.068
71940893|NCT00386009|143403119|SUPERIORITY_OR_OTHER|||||||0.626||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.626
71940894|NCT00386009|143403120|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
71940895|NCT00386009|143403121|SUPERIORITY_OR_OTHER|||||||0.837||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.837
71940896|NCT00386009|143403122|SUPERIORITY_OR_OTHER|||||||0.4||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.400
71940897|NCT00386009|143403123|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.864
71940898|NCT00386009|143403124|SUPERIORITY_OR_OTHER|||||||0.34||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.340
71940899|NCT00386009|143403125|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
71940900|NCT00386009|143403126|SUPERIORITY_OR_OTHER|||||||0.609||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.609
71940901|NCT00386009|143403127|SUPERIORITY_OR_OTHER|||||||0.427||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.427
71940902|NCT00386009|143403128|SUPERIORITY_OR_OTHER|||||||0.838||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.838
71940903|NCT00386009|143403129|SUPERIORITY_OR_OTHER|||||||0.09||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.090
71940904|NCT00386009|143403130|SUPERIORITY_OR_OTHER|||||||0.113||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||0.113
71940905|NCT00386009|143403133|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA|||||||<0.001
71940906|NCT00860405|143403139|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.|Ratio of LS-means|0.98|||||TWO_SIDED|95.0|0.84|1.16||Null hypothesis tested by calculating a 2-sided 95% CI for ratio of LS-means μVoluven/μHSA based on ANOVA incl.treatment+centre as effects. If 95% CI was within equivalence range(0.55, 1.82), significant equivalence was concluded (Type I error: 2.5%)|ANOVA|Primary endpoint specified + analysed for PP and ITT population. Confirmatory analysis based on PP population only, no adjustment for multiplicity.|Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%|The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 \< μVoluven/μHSA \< 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.||1.16|0.84|
71940907|NCT01807637|143403154|SUPERIORITY||Mean Difference (Final Values)|9.1|STANDARD_ERROR_OF_MEAN|5.37||0.05|TWO_SIDED||||||Mixed Models Analysis|||||||.05
71940908|NCT01807637|143403155|SUPERIORITY||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|1.12||0.05|TWO_SIDED||||||ANOVA|||||||.05
71940909|NCT01807637|143403156|SUPERIORITY||Mean Difference (Final Values)|15.67|STANDARD_DEVIATION|3.41||0.05|TWO_SIDED||||||ANOVA|||||||.05
71940910|NCT00320112|143403169|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.004|TWO_SIDED|||||no differences between arms in baseline characteristics at \<0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.|Regression, Linear|we used STATA 11's xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.||||||0.004
71940911|NCT00320112|143403170|SUPERIORITY_OR_OTHER|||||||0.91|TWO_SIDED|||||this is a priori design|Regression, Linear|||||||.91
71940912|NCT00320112|143403171|SUPERIORITY_OR_OTHER|||||||0.1|TWO_SIDED||||||Regression, Linear|||||||0.10
71940913|NCT00320112|143403172|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Regression, Linear|||||||0.02
71940914|NCT02899338|143403173|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using the analysis of variance (ANOVA)|Adjusted geometric mean ratio|101.71|STANDARD_ERROR_OF_MEAN|42.28|||TWO_SIDED|90.0|91.31|113.29|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual geometric coefficient of variation (gCV)|Comparison AI versus PFS||113.29|91.31|
71940915|NCT02899338|143403174|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|100.11|STANDARD_ERROR_OF_MEAN|23.72|||TWO_SIDED|90.0|94.17|106.43|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||106.43|94.17|
71940916|NCT02899338|143403175|EQUIVALENCE|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|103.19|STANDARD_ERROR_OF_MEAN|48.21|||TWO_SIDED|90.0|91.38|116.53|||ANOVA|The results are based on ANOVA model on the logarithmic scale with fixed effects for treatment and baseline body weight.|Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS||116.53|91.38|
71940917|NCT00796822|143403193|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.87|STANDARD_DEVIATION|1.09||0.44|TWO_SIDED|95.0|-1.53|3.28|||t-test, 2 sided|||The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.||3.28|-1.53|0.44
71940918|NCT00796822|143403194|SUPERIORITY|There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.|Median Difference (Net)|149.1|STANDARD_DEVIATION|151.8||0.03|TWO_SIDED|95.0|16.4|281.9|||t-test, 2 sided|||||281.9|16.4|0.03
71940919|NCT00890981|143403220|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.7||||0.0766||95.0|-0.4|7.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction||7.8|-0.4|0.0766
71940920|NCT00890981|143403221|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.5||||0.1648||95.0|-0.6|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.6|0.1648
71940921|NCT00890981|143403222|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.0228||95.0|0.1|1.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.7|0.1|0.0228
71940922|NCT00890981|143403223|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.656||95.0|-2.5|4.0|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.||4.0|-2.5|0.6560
71940923|NCT00890981|143403224|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.8||||0.0594||95.0|-0.1|3.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.7|-0.1|0.0594
71940924|NCT00890981|143403225|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.6||||0.0032||95.0|0.9|4.3|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||4.3|0.9|0.0032
71940925|NCT00890981|143403226|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.2897||95.0|-0.4|1.2|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.||1.2|-0.4|0.2897
71940926|NCT00890981|143403227|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.9||||0.0067||95.0|1.1|6.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||6.7|1.1|0.0067
71940927|NCT00890981|143403228|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0184||95.0|0.4|3.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.8|0.4|0.0184
71693618|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.78||0.5706||95.0|-14.7|8.1|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.1|-14.7|0.5706
71693619|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.3|STANDARD_ERROR_OF_MEAN|5.95||0.4708||95.0|-16.0|7.4|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.4|-16.0|0.4708
71693620|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8|STANDARD_ERROR_OF_MEAN|5.72||0.6202||95.0|-8.4|14.1|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||14.1|-8.4|0.6202
71693621|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9|STANDARD_ERROR_OF_MEAN|6.04||0.4177||95.0|-16.8|7.0|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.0|-16.8|0.4177
71940928|NCT00890981|143403229|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6||||0.0911||95.0|-0.3|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|-0.3|0.0911
71940929|NCT00890981|143403230|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.1||||0.0035||95.0|0.7|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||3.5|0.7|0.0035
71693622|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.6|STANDARD_ERROR_OF_MEAN|5.75||0.6509||95.0|-8.7|13.9|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.9|-8.7|0.6509
71693623|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|5.86||0.8273||95.0|-10.3|12.8|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||12.8|-10.3|0.8273
71693624|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.4|STANDARD_ERROR_OF_MEAN|5.94||0.2842||95.0|-18.1|5.3|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.3|-18.1|0.2842
71693625|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|5.72||0.7041||95.0|-9.1|13.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.5|-9.1|0.7041
71940930|NCT00890981|143403231|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.1||||0.0591||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0591
71940931|NCT00890981|143403232|SUPERIORITY_OR_OTHER||Ratio of Denosumab to Placebo|1.2||||0.0079||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.||1.3|1.0|0.0079
71940932|NCT00453362|143403233|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.017|TWO_SIDED|95.0|0.11|0.87||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.||0.87|0.11|0.017
71940933|NCT00453362|143403235|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.076|TWO_SIDED|95.0|0.06|1.42||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.||1.42|0.06|0.076
71940934|NCT00453362|143403237|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.17||||0.008|TWO_SIDED|95.0|0.04|0.73||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.||0.73|0.04|0.008
71940935|NCT00453362|143403238|SUPERIORITY_OR_OTHER|||||||0.049||95.0||||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank|||The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.||||0.049
71940936|NCT00453362|143403239|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.36||||0.073|TWO_SIDED|95.0|0.11|1.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.||1.16|0.11|0.073
71940937|NCT00453362|143403242|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.618|TWO_SIDED|95.0|0.14|3.21||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.||3.21|0.14|0.618
71940938|NCT00453362|143403243|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.38||||0.163|TWO_SIDED|95.0|0.09|1.57||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.||1.57|0.09|0.163
71940939|NCT00453362|143403244|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.35||||0.327|TWO_SIDED|95.0|0.04|3.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Progressive Disease.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.||3.16|0.04|0.327
71940940|NCT04885296|143403246|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|1.32|||TWO_SIDED|95.0|-2.2|3.0|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||3.0|-2.2|
71940941|NCT04885296|143403247|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.62|||TWO_SIDED|95.0|-4.0|2.3|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||2.3|-4.0|
71940942|NCT04885296|143403248|NON_INFERIORITY|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference (Test - Control) was greater than -5. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers.|LS Mean Difference|-1.5|STANDARD_ERROR_OF_MEAN|1.61|||TWO_SIDED|95.0|-4.7|1.7|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||1.7|-4.7|
71940943|NCT01027143|143403255|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71940944|NCT02564263|143403268|SUPERIORITY||Hazard Ratio (HR)|0.77||||0.00894|TWO_SIDED|95.0|0.63|0.96||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||0.96|0.63|0.00894
71940945|NCT02564263|143403269|SUPERIORITY||Hazard Ratio (HR)|0.7||||0.00855|TWO_SIDED|95.0|0.52|0.94||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||0.94|0.52|0.00855
71761133|NCT01039376|143023894|SUPERIORITY||Mean Difference (Final Values)|1.38||||0.1999|TWO_SIDED|95.0|-0.73|3.49||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Thermometer Score|||3.49|-0.73|0.1999
71940946|NCT02564263|143403270|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.0531|TWO_SIDED|95.0|0.75|1.05||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction \[EGJ\])|||1.05|0.75|0.0531
71940947|NCT02564263|143403271|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.287|TWO_SIDED|95.0|0.94|1.31||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic \& a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||1.31|0.94|0.287
71940948|NCT02564263|143403272|SUPERIORITY||Difference in Percentages|6.4||||0.0037|TWO_SIDED|95.0|1.7|11.2||One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||11.2|1.7|0.0037
71940949|NCT02564263|143403273|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.216|TWO_SIDED|95.0|0.75|1.13||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)|||1.13|0.75|0.216
71940950|NCT02564263|143403274|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.015|TWO_SIDED|95.0|0.54|0.97||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)|||0.97|0.54|0.015
71940951|NCT02564263|143403275|SUPERIORITY||Difference in Percentages|9.2||||0.0022|TWO_SIDED|95.0|3.0|15.8||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW)|||15.8|3.0|0.0022
71940952|NCT02564263|143403276|SUPERIORITY||Difference in Percentages|15.1||||0.0006|TWO_SIDED|95.0|6.2|24.7||One-sided p-value for testing. H0: difference in %=0; H1: difference in %\>0.|Miettinen & Nurminen method||Miettinen \& Nurminen method stratified by geographic region (Asia vs RoW) \& tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)|||24.7|6.2|0.0006
71940953|NCT02319148|143403279|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|105.28|||||TWO_SIDED|90.0|92.11|120.34|||Mixed Models Analysis|||||120.34|92.11|
71940954|NCT02319148|143403279|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|92.54|||||TWO_SIDED|90.0|80.96|105.77|||Mixed Models Analysis|||||105.77|80.96|
71940955|NCT02319148|143403279|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|116.36|||||TWO_SIDED|90.0|101.86|132.92|||Mixed Models Analysis|||||132.92|101.86|
71940956|NCT02319148|143403280|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|90.16|||||TWO_SIDED|90.0|78.57|103.46|||Mixed Models Analysis|||||103.46|78.57|
71761134|NCT01039376|143023906|SUPERIORITY||Hazard Ratio (HR)|1.547|||||TWO_SIDED|95.0|1.051|2.276|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 6q-, or +12q or 13q-/no abberation|||2.276|1.051|
71940957|NCT02319148|143403280|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.38|||||TWO_SIDED|90.0|92.7|122.07|||Mixed Models Analysis|||||122.07|92.70|
71940958|NCT02319148|143403280|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|101.71|||||TWO_SIDED|90.0|88.68|116.66|||Mixed Models Analysis|||||116.66|88.68|
71940959|NCT02319148|143403281|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.33|||||TWO_SIDED|90.0|79.49|104.94|||Mixed Models Analysis|||||104.94|79.49|
71940960|NCT02319148|143403281|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|106.97|||||TWO_SIDED|90.0|93.1|122.91|||Mixed Models Analysis|||||122.91|93.10|
71940961|NCT02319148|143403281|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.69|||||TWO_SIDED|90.0|89.42|117.93|||Mixed Models Analysis|||||117.93|89.42|
71940962|NCT02465567|143403313|SUPERIORITY||Rate Ratio|0.76|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
71940963|NCT02465567|143403313|SUPERIORITY||Rate Ratio|0.87||||0.0027|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0027
71940964|NCT02465567|143403313|SUPERIORITY||Rate Ratio|0.75|||<|0.0001|TWO_SIDED|95.0|0.69|0.83|||Negative Binomial Regression|||||0.83|0.69|<0.0001
71940965|NCT02465567|143403313|SUPERIORITY||Rate Ratio|0.86||||0.002|TWO_SIDED|95.0|0.79|0.95|||Negative Binomial Regression|||||0.95|0.79|0.0020
71940966|NCT02465567|143403314|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0035|TWO_SIDED|95.0|0.807|0.959|||Regression, Cox|||||0.959|0.807|0.0035
71940967|NCT02465567|143403314|SUPERIORITY||Hazard Ratio (HR)|0.887||||0.057|TWO_SIDED|95.0|0.814|0.966|||Regression, Cox|||||0.966|0.814|0.057
71940968|NCT02465567|143403314|SUPERIORITY||Hazard Ratio (HR)|0.866||||0.0011|TWO_SIDED|95.0|0.794|0.944|||Regression, Cox|||||0.944|0.794|0.0011
71940969|NCT02465567|143403314|SUPERIORITY||Hazard Ratio (HR)|0.873||||0.0019|TWO_SIDED|95.0|0.801|0.951|||Regression, Cox|||||0.951|0.801|0.0019
71940970|NCT02465567|143403315|SUPERIORITY||Mean Difference (Final Values)|-0.51|||<|0.0001|TWO_SIDED|95.0|-0.68|-0.34|||Linear Repeated Measures|||||-0.34|-0.68|<0.0001
71940971|NCT02465567|143403315|SUPERIORITY||Mean Difference (Final Values)|-0.37|||<|0.0001|TWO_SIDED|95.0|-0.54|-0.2|||Linear Repeated Measures|||||-0.20|-0.54|<0.0001
71940972|NCT02465567|143403315|SUPERIORITY||Mean Difference (Final Values)|-0.35|||<|0.0001|TWO_SIDED|95.0|-0.53|-0.18|||Linear Repeated Measures|||||-0.18|-0.53|<0.0001
71940973|NCT02465567|143403315|SUPERIORITY||Mean Difference (Final Values)|-0.22||||0.0127|TWO_SIDED|95.0|-0.39|-0.05|||Linear Repeated Measures|||||-0.05|-0.39|0.0127
71940974|NCT02465567|143403316|SUPERIORITY||Odds Ratio (OR)|1.358|||<|0.0001|TWO_SIDED|95.0|1.199|1.539|||Regression, Logistic|||||1.539|1.199|<0.0001
71940975|NCT02465567|143403316|SUPERIORITY||Odds Ratio (OR)|1.246||||0.0005|TWO_SIDED|95.0|1.1|1.41|||Regression, Logistic|||||1.410|1.100|0.0005
71940976|NCT02465567|143403316|SUPERIORITY||Odds Ratio (OR)|1.283|||<|0.0004|TWO_SIDED|95.0|1.133|1.454|||Regression, Logistic|||||1.454|1.133|<0.0004
71940977|NCT02465567|143403316|SUPERIORITY||Odds Ratio (OR)|1.177||||0.0103|TWO_SIDED|95.0|1.039|1.333|||Regression, Logistic|||||1.333|1.039|0.0103
71940978|NCT02465567|143403317|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0111|TWO_SIDED|95.0|0.34|0.87|||Regression, Cox|||||0.870|0.340|0.0111
71940979|NCT02465567|143403317|SUPERIORITY||Hazard Ratio (HR)|0.782||||0.3401|TWO_SIDED|95.0|0.472|1.296|||Regression, Cox|||||1.296|0.472|0.3401
71940980|NCT02465567|143403317|SUPERIORITY||Hazard Ratio (HR)|0.789||||0.269|TWO_SIDED|95.0|0.518|1.201|||Regression, Cox|||||1.201|0.518|0.2690
71940981|NCT02465567|143403317|SUPERIORITY||Hazard Ratio (HR)|1.134||||0.5918|TWO_SIDED|95.0|0.716|1.796|||Regression, Cox|||||1.796|0.716|0.5918
71940982|NCT02465567|143403318|SUPERIORITY||Rate Ratio|0.84||||0.6552|TWO_SIDED|95.0|0.69|1.03|||Negative Binomial Regression|||||1.03|0.69|0.6552
71940983|NCT02465567|143403318|SUPERIORITY||Rate Ratio|0.8||||0.0221|TWO_SIDED|95.0|0.66|0.97|||Negative Binomial Regression|||||0.97|0.66|0.0221
71940984|NCT02465567|143403318|SUPERIORITY||Rate Ratio|0.88||||0.2157|TWO_SIDED|95.0|0.72|1.08|||Negative Binomial Regression|||||1.08|0.72|0.2157
71940985|NCT02465567|143403318|SUPERIORITY||Rate Ratio|0.83||||0.0647|TWO_SIDED|95.0|0.69|1.01|||Negative Binomial Regression|||||1.01|0.69|0.0647
71940986|NCT00497796|143403319|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Based on the ICH guidance, the hypothesis of non-inferiority can be tested using a one-sided 97.5% confidence interval's (CI) upper bound comparing with the non-inferiority margin of 5% (0.05).|Rate difference|0.041|||||TWO_SIDED|95.0|-0.038|0.119|||||Rate difference is the rate of maribavir minus the rate of ganciclovir|||0.119|-0.038|
71940987|NCT00497796|143403319|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.586||||0.2754|TWO_SIDED|95.0|0.682|3.69||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||3.690|0.682|0.2754
71940988|NCT00497796|143403320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.793||||0.0283|TWO_SIDED|95.0|1.065|3.02||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of the pp65 antigenemia assay||3.020|1.065|0.0283
71940989|NCT00497796|143403320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.284||||0.0024|TWO_SIDED|95.0|1.338|3.9|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||3.900|1.338|0.0024
71940990|NCT00497796|143403320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.177||||0.0053|TWO_SIDED|95.0|1.259|3.767||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||3.767|1.259|0.0053
71940991|NCT00497796|143403320|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.388||||0.2339|TWO_SIDED|95.0|0.811|2.377||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||2.377|0.811|0.2339
71940992|NCT00497796|143403321|SUPERIORITY_OR_OTHER_LEGACY||Adjusted Hazard Ratio|2.25|||<|0.0001|TWO_SIDED|95.0|1.62|3.14|||Log Rank||Maribavir versus ganciclovir; Cox's proportional hazards regression model: time = receipt of induction ALA and geographic region (US or Europe) + treatment.|Analysis of time to onset||3.14|1.62|<0.0001
71940993|NCT00497796|143403322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant||||0.0008
71940994|NCT00497796|143403322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3742|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant||||0.3742
71940995|NCT00497796|143403323|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007|TWO_SIDED|||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||||||0.0007
71940996|NCT00497796|143403324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.041|||<|0.0001|TWO_SIDED|95.0|2.179|7.494||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia assay||7.494|2.179|<0.0001
71940997|NCT00497796|143403324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.448|||<|0.0001|TWO_SIDED|95.0|3.404|12.213||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay||12.213|3.404|<0.0001
71940998|NCT00497796|143403324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|6.02|||<|0.0001|TWO_SIDED|95.0|3.342|10.843||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay||10.843|3.342|<0.0001
71940999|NCT00497796|143403324|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|11.165|||<|0.0001|TWO_SIDED|95.0|4.146|30.069||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy||30.069|4.146|<0.0001
71941000|NCT04276883|143403335|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71941001|NCT04276883|143403335|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||||||<0.0001
71941002|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
71941003|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 120 minutes post-dose||||<0.0001
71941004|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
71941005|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 90 minutes post-dose||||<0.0001
71941006|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
71693626|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|6.07||0.7216||95.0|-14.1|9.8|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-14.1|0.7216
71941007|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 60 minutes post-dose||||<0.0001
71941008|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
71941009|NCT04276883|143403336|SUPERIORITY||||||<|0.0001|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 45 minutes post-dose||||<0.0001
71941010|NCT04276883|143403336|SUPERIORITY|||||||0.0006|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 30 minutes post-dose||||0.0006
71941011|NCT04276883|143403336|SUPERIORITY|||||||0.0028|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 30 minutes post-dose||||0.0028
71941012|NCT04276883|143403336|SUPERIORITY|||||||0.007|||||||Mixed Models Analysis|||180 Micrograms versus placebo; 20 minutes post-dose||||0.0070
71941013|NCT04276883|143403336|SUPERIORITY|||||||0.0092|||||||Mixed Models Analysis|||120 Micrograms versus placebo; 20 minutes post-dose||||0.0092
71941014|NCT00765648|143403354|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-9.3||||0.04|TWO_SIDED|95.0|-18.0|-0.6|||Chi-squared|||||-0.6|-18.0|0.04
71941015|NCT00765648|143403355|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|||||||<0.001
71941016|NCT00765648|143403356|SUPERIORITY_OR_OTHER|||||||0.76|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.76
71941017|NCT00765648|143403357|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED|95.0|||||Chi-squared|||||||0.38
71941018|NCT00765648|143403358|SUPERIORITY_OR_OTHER|||||||0.18|TWO_SIDED|95.0|||||Chi-squared|||||||0.18
71941019|NCT00765648|143403359|SUPERIORITY_OR_OTHER|||||||0.11|TWO_SIDED|95.0|||||Wilcoxon (Mann-Whitney)|||||||0.11
71941020|NCT01062256|143403379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.216|TWO_SIDED|95.0|0.64|1.1||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.10|0.64|0.216
71941021|NCT01062256|143403379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.513|TWO_SIDED|95.0|0.72|1.18||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.18|0.72|0.513
71941022|NCT01062256|143403379|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.459|TWO_SIDED|95.0|0.87|1.38||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.||1.38|0.87|0.459
71941023|NCT01062256|143403380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.195|TWO_SIDED|95.0|0.65|1.09||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.09|0.65|0.195
71941024|NCT01062256|143403380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.438|TWO_SIDED|95.0|0.71|1.16||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.16|0.71|0.438
71941025|NCT01062256|143403380|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.497|TWO_SIDED|95.0|0.87|1.34||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.||1.34|0.87|0.497
71941026|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.25|TWO_SIDED|95.0|0.64|1.12||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.12|0.64|0.250
71941027|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.802|TWO_SIDED|95.0|0.75|1.25||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.25|0.75|0.802
71941028|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.188|TWO_SIDED|95.0|0.94|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose||1.39|0.94|0.188
71941029|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.78||||0.091|TWO_SIDED|95.0|0.58|1.04||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.04|0.58|0.091
71941030|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.9||||0.465|TWO_SIDED|95.0|0.69|1.19||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.19|0.69|0.465
71941031|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.16||||0.207|TWO_SIDED|95.0|0.92|1.46||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose||1.46|0.92|0.207
71941032|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.81||||0.122|TWO_SIDED|95.0|0.62|1.06||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.06|0.62|0.122
71941033|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.165|TWO_SIDED|95.0|0.66|1.07||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.07|0.66|0.165
71941034|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.711|TWO_SIDED|95.0|0.83|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose||1.32|0.83|0.711
71941035|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.215|TWO_SIDED|95.0|0.64|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.11|0.64|0.215
71941036|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.88||||0.367|TWO_SIDED|95.0|0.67|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.16|0.67|0.367
71941037|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.687|TWO_SIDED|95.0|0.82|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose||1.35|0.82|0.687
71941038|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.73|TWO_SIDED|95.0|0.67|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.32|0.67|0.730
71941039|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.923|TWO_SIDED|95.0|0.74|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.39|0.74|0.923
71941040|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.08||||0.573|TWO_SIDED|95.0|0.83|1.4||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose||1.40|0.83|0.573
71941041|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84||||0.289|TWO_SIDED|95.0|0.61|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.16|0.61|0.289
71941042|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.379|TWO_SIDED|95.0|0.64|1.18||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.18|0.64|0.379
71941043|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.04||||0.785|TWO_SIDED|95.0|0.79|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose||1.37|0.79|0.785
71941044|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.82||||0.194|TWO_SIDED|95.0|0.6|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.60|0.194
71941045|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.212|TWO_SIDED|95.0|0.62|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.11|0.62|0.212
71761135|NCT01039376|143023906|SUPERIORITY||Hazard Ratio (HR)|9.303|||||TWO_SIDED|95.0|4.934|17.54|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 17p-/no abberation|||17.540|4.934|
71941046|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.02||||0.901|TWO_SIDED|95.0|0.77|1.34||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose||1.34|0.77|0.901
71941047|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.93||||0.6|TWO_SIDED|95.0|0.7|1.23||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.23|0.70|0.600
71941048|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.853|TWO_SIDED|95.0|0.74|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.29|0.74|0.853
71941049|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.05||||0.736|TWO_SIDED|95.0|0.79|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose||1.39|0.79|0.736
71941050|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.95||||0.744|TWO_SIDED|95.0|0.7|1.3||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.30|0.70|0.744
71941051|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.98||||0.904|TWO_SIDED|95.0|0.72|1.33||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.33|0.72|0.904
71941052|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.828|TWO_SIDED|95.0|0.77|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose||1.39|0.77|0.828
71941053|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.8||||0.147|TWO_SIDED|95.0|0.59|1.08||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.08|0.59|0.147
71941054|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.87||||0.345|TWO_SIDED|95.0|0.65|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.16|0.65|0.345
71941055|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.532|TWO_SIDED|95.0|0.83|1.44||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose||1.44|0.83|0.532
71941056|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.83||||0.261|TWO_SIDED|95.0|0.61|1.15||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.15|0.61|0.261
71941057|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.601|TWO_SIDED|95.0|0.69|1.24||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.24|0.69|0.601
71941058|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.47|TWO_SIDED|95.0|0.84|1.47||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose||1.47|0.84|0.470
71941059|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.834|TWO_SIDED|95.0|0.71|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.32|0.71|0.834
71941060|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.07||||0.628|TWO_SIDED|95.0|0.81|1.43||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.43|0.81|0.628
71941061|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.11||||0.481|TWO_SIDED|95.0|0.83|1.48||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose||1.48|0.83|0.481
71941062|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.749|TWO_SIDED|95.0|0.65|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.37|0.65|0.749
71761136|NCT01039376|143023906|SUPERIORITY||Hazard Ratio (HR)|4.219|||||TWO_SIDED|95.0|2.468|7.21|||||HR estimated for Cytogenetics Group (based on \>=20% cut-off) with 11q-/no abberation|||7.210|2.468|
71941063|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.97||||0.857|TWO_SIDED|95.0|0.7|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.35|0.70|0.857
71941064|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.03||||0.847|TWO_SIDED|95.0|0.76|1.41||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose||1.41|0.76|0.847
71941065|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.77||||0.146|TWO_SIDED|95.0|0.54|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.09|0.54|0.146
71941066|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.94||||0.702|TWO_SIDED|95.0|0.69|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.29|0.69|0.702
71941067|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.228|TWO_SIDED|95.0|0.88|1.69||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose||1.69|0.88|0.228
71941068|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75||||0.13|TWO_SIDED|95.0|0.51|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.09|0.51|0.130
71941069|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.85||||0.371|TWO_SIDED|95.0|0.6|1.21||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.21|0.60|0.371
71941070|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.14||||0.43|TWO_SIDED|95.0|0.82|1.58||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose||1.58|0.82|0.430
71941071|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.76||||0.177|TWO_SIDED|95.0|0.51|1.13||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.13|0.51|0.177
71941072|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.91||||0.58|TWO_SIDED|95.0|0.64|1.28||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.28|0.64|0.580
71941073|NCT01062256|143403381|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.19||||0.333|TWO_SIDED|95.0|0.84|1.7||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose||1.70|0.84|0.333
71941074|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.264|TWO_SIDED|95.0|-0.08|0.27||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.27|-0.08|0.264
71941075|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.03||||0.737|TWO_SIDED|95.0|-0.2|0.14||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.14|-0.20|0.737
71941076|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.078|TWO_SIDED|95.0|-0.27|0.01||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose||0.01|-0.27|0.078
71941077|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.125|TWO_SIDED|95.0|-0.04|0.36||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.36|-0.04|0.125
71941078|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.688|TWO_SIDED|95.0|-0.16|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.24|-0.16|0.688
71941079|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.166|TWO_SIDED|95.0|-0.29|0.05||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose||0.05|-0.29|0.166
71941080|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.13||||0.233|TWO_SIDED|95.0|-0.09|0.35||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.35|-0.09|0.233
71941081|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02||||0.848|TWO_SIDED|95.0|-0.24|0.19||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.19|-0.24|0.848
71941082|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.093|TWO_SIDED|95.0|-0.33|0.03||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose||0.03|-0.33|0.093
71941083|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.406|TWO_SIDED|95.0|-0.14|0.34||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.34|-0.14|0.406
71941084|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.991|TWO_SIDED|95.0|-0.24|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.24|-0.24|0.991
71941085|NCT01062256|143403382|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.306|TWO_SIDED|95.0|-0.3|0.09||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose||0.09|-0.30|0.306
71941086|NCT01062256|143403383|SUPERIORITY_OR_OTHER||Goodman-Kruskal Gamma statistic|0.15||||0.254|TWO_SIDED|95.0|-0.09|0.39||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.39|-0.09|0.254
71941087|NCT01062256|143403383|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.01||||0.949|TWO_SIDED|95.0|-0.25|0.23||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.23|-0.25|0.949
71941088|NCT01062256|143403383|SUPERIORITY_OR_OTHER||weighted Goodman-Kruskal Gamma statistic|-0.12||||0.256|TWO_SIDED|95.0|-0.32|0.08||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.||0.08|-0.32|0.256
71941089|NCT00891293|143403403|SUPERIORITY_OR_OTHER||Median Difference (Net)|3.3|STANDARD_DEVIATION|29.01||0.9999||95.0|-2.8|9.4|||ANOVA||Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment|For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.||9.4|-2.8|0.9999
71941090|NCT01430741|143403444|SUPERIORITY_OR_OTHER||||||=|0.04|||||||Mixed Models Analysis|||Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.04
71941091|NCT01430741|143403445|SUPERIORITY_OR_OTHER||||||=|0.21|||||||Mixed Models Analysis|||Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.21
71941092|NCT01430741|143403445|SUPERIORITY_OR_OTHER||||||=|0.07|||||||Mixed Models Analysis|||Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.07
71941093|NCT01430741|143403446|SUPERIORITY_OR_OTHER||||||=|0.14|||||||Mixed Models Analysis|||Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.14
71941094|NCT01430741|143403446|SUPERIORITY_OR_OTHER||||||=|0.19|||||||Mixed Models Analysis|||Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.19
71941095|NCT01430741|143403447|SUPERIORITY_OR_OTHER||||||=|0.24|||||||Mixed Models Analysis|||Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.||||=.24
71941096|NCT01430741|143403448|SUPERIORITY_OR_OTHER||||||=|0.481|||||||Regression, Cox|||We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.||||=.481
71941097|NCT00117949|143403455|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Log Rank|||||||<0.001
71941098|NCT00117949|143403455|SUPERIORITY_OR_OTHER||Median days to insufficient T response|84.0||||||95.0|35.0|112.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.||112|35|
71941099|NCT00117949|143403455|SUPERIORITY_OR_OTHER||Median days to insufficient T response|98.0||||||95.0|70.0|126.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||126|70|
71941100|NCT00117949|143403455|SUPERIORITY_OR_OTHER||Median days to insufficient T response|35.0||||||95.0|14.0|98.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response||98|14|
71941101|NCT00117949|143403456|SUPERIORITY_OR_OTHER|||||||0.003||95.0|||||Log Rank|Participants not castrated were censored as of the days from dosing for the last available observation.||||||0.003
71941102|NCT00117949|143403456|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|3.0|7.0||||||Kaplan-Meier estimates of the median time to testosterone castration.||7|3|
71941103|NCT00117949|143403456|SUPERIORITY_OR_OTHER||Median time to castration (days)|3.0||||||95.0|1.0|3.0||||||Kaplan-Meier estimates of the time to testosterone castration.||3|1|
71941104|NCT00117949|143403457|SUPERIORITY_OR_OTHER||Percentage of participants|0.0||||||95.0|0.0|0.0||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||0|0|
71941105|NCT00117949|143403457|SUPERIORITY_OR_OTHER||Percentage of participants|42.7||||||95.0|22.0|63.4||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||63.4|22|
71941106|NCT00117949|143403457|SUPERIORITY_OR_OTHER||Percentage of participants|61.6||||||95.0|41.8|81.3||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||81.3|41.8|
71941107|NCT00117949|143403457|SUPERIORITY_OR_OTHER||Percentage of participants|35.6||||||95.0|15.8|55.5||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.||55.5|15.8|
71941108|NCT00117949|143403458|SUPERIORITY_OR_OTHER|||||||0.181||95.0|||||Cochran-Armitage Trend Test.|||||||0.181
71941109|NCT00117949|143403458|SUPERIORITY_OR_OTHER||Percentage of participants|10.0||||||95.0|0.3|44.5||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||44.5|0.3|
71941110|NCT00117949|143403458|SUPERIORITY_OR_OTHER||Percentage of participants|70.8||||||95.0|48.9|87.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||87.4|48.9|
71941111|NCT00117949|143403458|SUPERIORITY_OR_OTHER||Percentage of participants|79.2||||||95.0|57.8|92.9||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||92.9|57.8|
71941112|NCT00117949|143403458|SUPERIORITY_OR_OTHER||Percentage of participants|54.2||||||95.0|32.8|74.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.||74.4|32.8|
71941113|NCT00117949|143403459|SUPERIORITY_OR_OTHER|||||||0.046||95.0|||||Log Rank|||||||0.046
71941114|NCT00117949|143403459|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
71941115|NCT00117949|143403459|SUPERIORITY_OR_OTHER||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||28|14|
71941116|NCT00117949|143403459|SUPERIORITY_OR_OTHER||days|28.0||||||95.0|14.0|41.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA||41|14|
71941117|NCT00117949|143403460|SUPERIORITY_OR_OTHER|||||||0.926||95.0|||||Log Rank|||||||0.926
71941118|NCT00117949|143403460|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|56.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||56|35|
71941119|NCT00117949|143403460|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|84.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||84|35|
71941120|NCT00117949|143403460|SUPERIORITY_OR_OTHER||days|56.0||||||95.0|35.0|100.0|||||The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.|Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.||100|35|
71941121|NCT04591626|143403462|SUPERIORITY||LS Mean Difference|-0.95|||<|0.001|TWO_SIDED|95.0|-1.14|-0.77|||Mixed Models Analysis|||||-0.77|-1.14|<0.001
71941122|NCT04591626|143403463|SUPERIORITY||Odds Ratio (OR)|10.91|||<|0.001|TWO_SIDED|95.0|5.35|22.28|||Regression, Logistic|||||22.28|5.35|<0.001
71941123|NCT04591626|143403464|SUPERIORITY||LS Mean Difference|-1.18|||<|0.001|TWO_SIDED|95.0|-1.77|-0.6|||Mixed Models Analysis|||||-0.60|-1.77|<0.001
71941124|NCT04591626|143403465|SUPERIORITY||LS Mean Difference|-14.82|||<|0.001|TWO_SIDED|95.0|-20.57|-9.08|||Mixed Models Analysis|||||-9.08|-20.57|<0.001
71941125|NCT04591626|143403466|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using Logistic Regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
71941126|NCT04591626|143403467|SUPERIORITY||Odds Ratio (OR)|7.59|||<|0.001|TWO_SIDED|95.0|4.27|13.48|||Regression, Logistic||OR was determined using logistic regression model: Variable = Baseline HbA1c value + OAM use + Treatment as variables.|||13.48|4.27|<0.001
71941127|NCT04591626|143403468|SUPERIORITY||Odds Ratio (OR)|4.58|||<|0.001|TWO_SIDED|95.0|2.64|7.95|||Regression, Logistic||OR was determined using logistic regression model with Baseline HbA1c value + OAM use + Treatment as variables.|||7.95|2.64|<0.001
71941128|NCT04591626|143403469|SUPERIORITY||LS Mean Difference|-26.3|||<|0.001|TWO_SIDED|95.0|-33.0|-19.6|||Mixed Models Analysis|||||-19.6|-33.0|<0.001
71941129|NCT04591626|143403470|SUPERIORITY||LS Mean Difference|-4.0||||0.006|TWO_SIDED|95.0|-6.86|-1.14|||Mixed Models Analysis|||||-1.14|-6.86|0.006
71941130|NCT02672553|143403471|SUPERIORITY||Median Difference (Final Values)|-12.5|||<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71941131|NCT02672553|143403472|SUPERIORITY||Median Difference (Final Values)|-10.5||||0.2077|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.2077
71941132|NCT03676803|143403499|OTHER||Mean Difference (Final Values)|10.6||||0.033|TWO_SIDED|||||p\<0.05 was defined as significant|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.||||0.033
71941133|NCT03676803|143403499|OTHER||Mean Difference (Final Values)|8.7||||0.097|TWO_SIDED|||||p\<0.05 was defined as significant.|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.||||0.097
71941134|NCT03676803|143403500|OTHER||Mean Difference (Final Values)|86.0||||0.49|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in mixed spices intervention group||||0.49
71941135|NCT03676803|143403500|OTHER||Mean Difference (Final Values)|55.7||||0.53|TWO_SIDED||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in placebo group||||0.53
71941136|NCT01355081|143403502|SUPERIORITY_OR_OTHER||Least square means difference|-2.03|STANDARD_ERROR_OF_MEAN|1.241||0.1031|TWO_SIDED|95.0|-4.467|0.413|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||0.413|-4.467|0.1031
71941137|NCT01355081|143403502|SUPERIORITY_OR_OTHER||Least square mean difference|-1.04|STANDARD_ERROR_OF_MEAN|1.233||0.4008|TWO_SIDED|95.0|-3.461|1.387|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.||||1.387|-3.461|0.4008
71941138|NCT01475474|143403508|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero||||<0.001
71941139|NCT01475474|143403509|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score||||<0.001
71941140|NCT01868009|143403516|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The response was analyzed and adjusted for study inhaler use sequence and preference question version. The method accounted for participants who indicated no preference.|Cochran-Mantel-Haenszel|||||||<0.001
71941141|NCT01046253|143403556|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||TWO_SIDED|90.0|97.4|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||114|97.4|
71941142|NCT01046253|143403557|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.5|||||TWO_SIDED|90.0|93.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|93.3|
71941143|NCT01046253|143403558|NON_INFERIORITY_OR_EQUIVALENCE|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test \[T\]/Reference\[R\]) of the identified metrics (e.g. AUC, Cmax).|Slope|98.0|||||TWO_SIDED|90.0|92.8|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||104|92.8|
71941144|NCT00860028|143403584|SUPERIORITY_OR_OTHER_LEGACY|||||||0.36||95.0|||||Chi-squared|||||||0.36
71941145|NCT00860028|143403585|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||95.0|||||General Linear Model|||||||0.06
71941146|NCT00860028|143403586|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03||95.0|||||Fisher Exact|||||||0.03
71941147|NCT01658943|143403590|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Log Rank|||||||0.15
71941148|NCT02405195|143403629|OTHER|||||||0.638||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA throughout measurement period (before, during and after CPB).||||0.638
71941149|NCT02405195|143403630|OTHER|||||||0.972||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||0.972
71761137|NCT01039376|143023906|SUPERIORITY||Hazard Ratio (HR)|1.832|||||TWO_SIDED|95.0|1.434|2.339|||||HR estimated for B2 Microglobulin Group 2 with 3500 as cut off: \>3500 ug/L/\<=3500 ug/L|||2.339|1.434|
71761138|NCT01039376|143023906|SUPERIORITY||Hazard Ratio (HR)|0.573|||||TWO_SIDED|95.0|0.432|0.76|||||HR estimated for IgVH Mutational Status 1 Mutated/Unmutated|||0.760|0.432|
71941150|NCT02405195|143403631|OTHER||||||<|0.001||||||Bonferroni-Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA||||<0.001
71941151|NCT01691248|143403646|SUPERIORITY_OR_OTHER||Percentage Difference|2.2||||0.2778|TWO_SIDED|95.0|-5.1|9.5||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.5|-5.1|0.2778
71941152|NCT01691248|143403647|SUPERIORITY_OR_OTHER||Percentage difference|0.6||||0.442|TWO_SIDED|95.0|-7.1|8.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||8.2|-7.1|0.4420
71941153|NCT01691248|143403648|SUPERIORITY_OR_OTHER||Percentage difference|1.9||||0.3091|TWO_SIDED|95.0|-5.5|9.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin|||9.2|-5.5|0.3091
71941154|NCT02863575|143403649|SUPERIORITY||Least square (LS) means difference|2.68||||0.306|TWO_SIDED|95.0|-2.46|7.82|||ANCOVA|||||7.82|-2.46|0.306
71941155|NCT02863575|143403650|SUPERIORITY||LS mean difference|1.09||||0.056|TWO_SIDED|95.0|-0.03|2.2|||ANCOVA|||SPRID 0-2||2.20|-0.03|0.056
71941156|NCT02863575|143403650|SUPERIORITY||LS means difference|11.13|||<|0.001|TWO_SIDED|95.0|9.54|12.73|||ANCOVA|||SPRID 0-2||12.73|9.54|< 0.001
71941157|NCT02863575|143403650|SUPERIORITY||LS mean difference|10.05|||<|0.001|TWO_SIDED|95.0|8.45|11.64|||ANCOVA|||SPRID 0-2||11.64|8.45|< 0.001
71941158|NCT02863575|143403650|SUPERIORITY||LS mean difference|1.58||||0.177|TWO_SIDED|95.0|-0.72|3.87|||ANCOVA|||SPRID 0-4||3.87|-0.72|0.177
71941159|NCT02863575|143403650|SUPERIORITY||LS mean difference|24.04|||<|0.001|TWO_SIDED|95.0|20.76|27.32|||ANCOVA|||SPRID 0-4||27.32|20.76|< 0.001
71941160|NCT02863575|143403650|SUPERIORITY||LS mean difference|22.46|||<|0.001|TWO_SIDED|95.0|19.18|25.75|||ANCOVA|||SPRID 0-4||25.75|19.18|< 0.001
71941161|NCT02863575|143403650|SUPERIORITY||LS mean difference|2.39||||0.201|TWO_SIDED|95.0|-1.28|6.06|||ANCOVA|||SPRID 0-6||6.06|-1.28|0.201
71941162|NCT02863575|143403650|SUPERIORITY||LS mean difference|34.3|||<|0.001|TWO_SIDED|95.0|29.06|39.55|||ANCOVA|||SPRID 0-6||39.55|29.06|< 0.001
71941163|NCT02863575|143403650|SUPERIORITY||LS mean difference|31.91|||<|0.001|TWO_SIDED|95.0|26.67|37.16|||ANCOVA|||SPRID 0-6||37.16|26.67|< 0.001
71941164|NCT02863575|143403650|SUPERIORITY||LS mean difference|40.85|||<|0.001|TWO_SIDED|95.0|33.49|48.2|||ANCOVA|||SPRID 0-8||48.20|33.49|< 0.001
71941165|NCT02863575|143403650|SUPERIORITY||LS mean difference|38.17|||<|0.001|TWO_SIDED|95.0|30.81|45.52|||ANCOVA|||SPRID 0-8||45.52|30.81|< 0.001
71941166|NCT02863575|143403651|SUPERIORITY||LS means difference|0.73||||0.066|TWO_SIDED|95.0|-0.05|1.5|||ANCOVA|||SPID 0-2||1.50|-0.05|0.066
71941167|NCT02863575|143403651|SUPERIORITY||LS means difference|7.55|||<|0.001|TWO_SIDED|95.0|6.44|8.66|||ANCOVA|||SPID 0-2||8.66|6.44|< 0.001
71941168|NCT02863575|143403651|SUPERIORITY||LS means difference|6.82|||<|0.001|TWO_SIDED|95.0|5.71|7.93|||ANCOVA|||SPID 0-2||7.93|5.71|< 0.001
71941169|NCT02863575|143403651|SUPERIORITY||LS means difference|1.14||||0.165|TWO_SIDED|95.0|-0.47|2.74|||ANCOVA|||SPID 0-4||2.74|-0.47|0.165
71941170|NCT02863575|143403651|SUPERIORITY||LS means difference|16.35|||<|0.001|TWO_SIDED|95.0|14.05|18.64|||ANCOVA|||SPID 0-4||18.64|14.05|< 0.001
71941171|NCT02863575|143403651|SUPERIORITY||LS means difference|15.21|||<|0.001|TWO_SIDED|95.0|12.91|17.51|||ANCOVA|||SPID 0-4||17.51|12.91|< 0.001
71941172|NCT02863575|143403651|SUPERIORITY||LS means difference|1.78||||0.172|TWO_SIDED|95.0|-0.78|4.34|||ANCOVA|||SPID 0-6||4.34|-0.78|0.172
71941173|NCT02863575|143403651|SUPERIORITY||LS means difference|23.37|||<|0.001|TWO_SIDED|95.0|19.71|27.03|||ANCOVA|||SPID 0-6||27.03|19.71|< 0.001
71941174|NCT02863575|143403651|SUPERIORITY||LS means difference|21.59|||<|0.001|TWO_SIDED|95.0|17.93|25.25|||ANCOVA|||SPID 0-6||25.25|17.93|< 0.001
71941175|NCT02863575|143403651|SUPERIORITY||LS means difference|2.1||||0.249|TWO_SIDED|95.0|-1.47|5.67|||ANCOVA|||SPID 0-8||5.67|-1.47|0.249
71941176|NCT02863575|143403651|SUPERIORITY||LS means difference|27.88|||<|0.001|TWO_SIDED|95.0|22.78|32.99|||ANCOVA|||SPID 0-8||32.99|22.78|< 0.001
71941177|NCT02863575|143403651|SUPERIORITY||LS means difference|25.79|||<|0.001|TWO_SIDED|95.0|20.68|30.89|||ANCOVA|||SPID 0-8||30.89|20.68|< 0.001
71941178|NCT02863575|143403652|SUPERIORITY||LS means difference|0.36||||0.044|TWO_SIDED|95.0|0.01|0.71|||ANCOVA|||TOTPAR 0-2||0.71|0.01|0.044
71693627|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9|STANDARD_ERROR_OF_MEAN|5.78||0.6188||95.0|-14.3|8.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.5|-14.3|0.6188
71941179|NCT02863575|143403652|SUPERIORITY||LS means difference|3.59|||<|0.001|TWO_SIDED|95.0|3.09|4.09|||ANCOVA|||TOTPAR 0-2||4.09|3.09|< 0.001
71941180|NCT02863575|143403652|SUPERIORITY||LS means difference|3.23|||<|0.001|TWO_SIDED|95.0|2.73|3.73|||ANCOVA|||TOTPAR 0-2||3.73|2.73|< 0.001
71941181|NCT02863575|143403652|SUPERIORITY||LS means difference|0.44||||0.224|TWO_SIDED|95.0|-0.27|1.15|||ANCOVA|||TOTPAR 0-4||1.15|-0.27|0.224
71941182|NCT02863575|143403652|SUPERIORITY||LS means difference|7.69|||<|0.001|TWO_SIDED|95.0|6.68|8.71|||ANCOVA|||TOTPAR 0-4||8.71|6.68|< 0.001
71941183|NCT02863575|143403652|SUPERIORITY||LS means difference|7.25|||<|0.001|TWO_SIDED|95.0|6.23|8.27|||ANCOVA|||TOTPAR 0-4||8.27|6.23|< 0.001
71941184|NCT02863575|143403652|SUPERIORITY||LS means difference|0.61||||0.293|TWO_SIDED|95.0|-0.53|1.75|||ANCOVA|||TOTPAR 0-6||1.75|-0.53|0.293
71941185|NCT02863575|143403652|SUPERIORITY||LS means difference|10.93|||<|0.001|TWO_SIDED|95.0|9.3|12.56|||ANCOVA|||TOTPAR 0-6||12.56|9.30|< 0.001
71941186|NCT02863575|143403652|SUPERIORITY||LS means difference|10.32|||<|0.001|TWO_SIDED|95.0|8.69|11.95|||ANCOVA|||TOTPAR 0-6||11.95|8.69|< 0.001
71941187|NCT02863575|143403652|SUPERIORITY||LS means difference|0.58||||0.476|TWO_SIDED|95.0|-1.03|2.19|||ANCOVA|||TOTPAR 0-8||2.19|-1.03|0.476
71941188|NCT02863575|143403652|SUPERIORITY||LS means difference|12.96|||<|0.001|TWO_SIDED|95.0|10.66|15.26|||ANCOVA|||TOTPAR 0-8||15.26|10.66|< 0.001
71941189|NCT02863575|143403652|SUPERIORITY||LS means difference|12.38|||<|0.001|TWO_SIDED|95.0|10.08|14.68|||ANCOVA|||TOTPAR 0-8||14.68|10.08|< 0.001
71941190|NCT02863575|143403653|SUPERIORITY||LS means difference|0.01||||0.975|TWO_SIDED|95.0|-0.35|0.36|||ANCOVA|||PRID at 0.25 hour||0.36|-0.35|0.975
71941191|NCT02863575|143403653|SUPERIORITY||LS means difference|0.12||||0.654|TWO_SIDED|95.0|-0.4|0.63|||ANCOVA|||PRID at 0.25 hour||0.63|-0.40|0.654
71941192|NCT02863575|143403653|SUPERIORITY||LS means difference|0.11||||0.67|TWO_SIDED|95.0|-0.4|0.62|||ANCOVA|||PRID at 0.25 hour||0.62|-0.40|0.670
71941193|NCT02863575|143403653|SUPERIORITY||LS means difference|-0.04||||0.917|TWO_SIDED|95.0|-0.7|0.63|||ANCOVA|||PRID at 0.5 hour||0.63|-0.70|0.917
71941194|NCT02863575|143403653|SUPERIORITY||LS means difference|2.26|||<|0.001|TWO_SIDED|95.0|1.31|3.2|||ANCOVA|||PRID at 0.5 hour||3.20|1.31|< 0.001
71941195|NCT02863575|143403653|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.35|3.24|||ANCOVA|||PRID at 0.5 hour||3.24|1.35|< 0.001
71941196|NCT02863575|143403653|SUPERIORITY||LS means difference|0.73||||0.039|TWO_SIDED|95.0|0.04|1.42|||ANCOVA|||PRID at 1 hour||1.42|0.04|0.039
71941197|NCT02863575|143403653|SUPERIORITY||LS means difference|6.11|||<|0.001|TWO_SIDED|95.0|5.12|7.1|||ANCOVA|||PRID at 1 hour||7.10|5.12|< 0.001
71941198|NCT02863575|143403653|SUPERIORITY||LS means difference|5.38|||<|0.001|TWO_SIDED|95.0|4.39|6.37|||ANCOVA|||PRID at 1 hour||6.37|4.39|< 0.001
71941199|NCT02863575|143403653|SUPERIORITY||LS means difference|0.84||||0.015|TWO_SIDED|95.0|0.16|1.52|||ANCOVA|||PRID at 1.5 hour||1.52|0.16|0.015
71941200|NCT02863575|143403653|SUPERIORITY||LS means difference|7.36|||<|0.001|TWO_SIDED|95.0|6.39|8.33|||ANCOVA|||PRID at 1.5 hour||8.33|6.39|< 0.001
71941201|NCT02863575|143403653|SUPERIORITY||LS means difference|6.52|||<|0.001|TWO_SIDED|95.0|5.55|7.49|||ANCOVA|||PRID at 1.5 hour||7.49|5.55|< 0.001
71941202|NCT02863575|143403653|SUPERIORITY||LS means difference|0.62||||0.071|TWO_SIDED|95.0|-0.05|1.3|||ANCOVA|||PRID at 2 hour||1.30|-0.05|0.071
71941203|NCT02863575|143403653|SUPERIORITY||LS means difference|7.62|||<|0.001|TWO_SIDED|95.0|6.65|8.58|||ANCOVA|||PRID at 2 hour||8.58|6.65|< 0.001
71941204|NCT02863575|143403653|SUPERIORITY||LS means difference|6.99|||<|0.001|TWO_SIDED|95.0|6.03|7.96|||ANCOVA|||PRID at 2 hour||7.96|6.03|< 0.001
71941205|NCT02863575|143403653|SUPERIORITY||LS means difference|0.41||||0.243|TWO_SIDED|95.0|-0.28|1.09|||ANCOVA|||PRID at 3 hour||1.09|-0.28|0.243
71941206|NCT02863575|143403653|SUPERIORITY||LS means difference|6.83|||<|0.001|TWO_SIDED|95.0|5.85|7.8|||ANCOVA|||PRID at 3 hour||7.80|5.85|< 0.001
71941207|NCT02863575|143403653|SUPERIORITY||LS means difference|6.42|||<|0.001|TWO_SIDED|95.0|5.44|7.4|||ANCOVA|||PRID at 3 hour||7.40|5.44|< 0.001
71941208|NCT02863575|143403653|SUPERIORITY||LS means difference|0.08||||0.823|TWO_SIDED|95.0|-0.65|0.82|||ANCOVA|||PRID at 4 hour||0.82|-0.65|0.823
71941209|NCT02863575|143403653|SUPERIORITY||LS means difference|6.08|||<|0.001|TWO_SIDED|95.0|5.02|7.14|||ANCOVA|||PRID at 4 hour||7.14|5.02|< 0.001
71941210|NCT02863575|143403653|SUPERIORITY||LS means difference|6.0|||<|0.001|TWO_SIDED|95.0|4.94|7.05|||ANCOVA|||PRID at 4 hour||7.05|4.94|< 0.001
71941211|NCT02863575|143403653|SUPERIORITY||LS means difference|0.31||||0.438|TWO_SIDED|95.0|-0.48|1.11|||ANCOVA|||PRID at 5 hour||1.11|-0.48|0.438
71941212|NCT02863575|143403653|SUPERIORITY||LS means difference|5.47|||<|0.001|TWO_SIDED|95.0|4.33|6.6|||ANCOVA|||PRID at 5 hour||6.60|4.33|< 0.001
71941213|NCT02863575|143403653|SUPERIORITY||LS means difference|5.15|||<|0.001|TWO_SIDED|95.0|4.01|6.29|||ANCOVA|||PRID at 5 hour||6.29|4.01|< 0.001
71941214|NCT02863575|143403653|SUPERIORITY||LS means difference|0.5||||0.25|TWO_SIDED|95.0|-0.35|1.35|||ANCOVA|||PRID at 6 hour||1.35|-0.35|0.250
71941215|NCT02863575|143403653|SUPERIORITY||LS means difference|4.8|||<|0.001|TWO_SIDED|95.0|3.58|6.02|||ANCOVA|||PRID at 6 hour||6.02|3.58|< 0.001
71941216|NCT02863575|143403653|SUPERIORITY||LS means difference|4.3|||<|0.001|TWO_SIDED|95.0|3.08|5.52|||ANCOVA|||PRID at 6 hour||5.52|3.08|< 0.001
71941217|NCT02863575|143403653|SUPERIORITY||LS means difference|0.11||||0.818|TWO_SIDED|95.0|-0.8|1.01|||ANCOVA|||PRID at 7 hour||1.01|-0.80|0.818
71941218|NCT02863575|143403653|SUPERIORITY||LS means difference|3.53|||<|0.001|TWO_SIDED|95.0|2.23|4.82|||ANCOVA|||PRID at 7 hour||4.82|2.23|< 0.001
71941219|NCT02863575|143403653|SUPERIORITY||LS means difference|3.42|||<|0.001|TWO_SIDED|95.0|2.12|4.71|||ANCOVA|||PRID at 7 hour||4.71|2.12|< 0.001
71941220|NCT02863575|143403653|SUPERIORITY||LS means difference|0.18||||0.698|TWO_SIDED|95.0|-0.74|1.11|||ANCOVA|||PRID at 8 hour||1.11|-0.74|0.698
71941221|NCT02863575|143403653|SUPERIORITY||LS means difference|3.02|||<|0.001|TWO_SIDED|95.0|1.69|4.34|||ANCOVA|||PRID at 8 hour||4.34|1.69|< 0.001
71941222|NCT02863575|143403653|SUPERIORITY||LS means difference|2.83|||<|0.001|TWO_SIDED|95.0|1.51|4.16|||ANCOVA|||PRID at 8 hour||4.16|1.51|< 0.001
71941223|NCT02863575|143403654|SUPERIORITY||LS means difference|0.04||||0.575|TWO_SIDED|94.0|-0.09|0.16|||ANCOVA|||PRR score at 0.25 hour||0.16|-0.09|0.575
71941224|NCT02863575|143403654|SUPERIORITY||LS means difference|0.07||||0.426|TWO_SIDED|95.0|-0.11|0.25|||ANCOVA|||PRR score at 0.25 hour||0.25|-0.11|0.426
71941225|NCT02863575|143403654|SUPERIORITY||LS means difference|0.04||||0.686|TWO_SIDED|95.0|-0.14|0.22|||ANCOVA|||PRR score at 0.25 hour||0.22|-0.14|0.686
71941226|NCT02863575|143403654|SUPERIORITY||LS means difference|0.07||||0.543|TWO_SIDED|95.0|-0.15|0.29|||ANCOVA|||PRR score at 0.5 hour||0.29|-0.15|0.543
71941227|NCT02863575|143403654|SUPERIORITY||LS means difference|0.81|||<|0.001|TWO_SIDED|95.0|0.49|1.12|||ANCOVA|||PRR score at 0.5 hour||1.12|0.49|< 0.001
71941228|NCT02863575|143403654|SUPERIORITY||LS means difference|0.74|||<|0.001|TWO_SIDED|95.0|0.42|1.05|||ANCOVA|||PRR score at 0.5 hour||1.05|0.42|< 0.001
71941229|NCT02863575|143403654|SUPERIORITY||LS means difference|0.24||||0.038|TWO_SIDED|95.0|0.01|0.46|||ANCOVA|||PRR score at 1 hour||0.46|0.01|0.038
71941230|NCT02863575|143403654|SUPERIORITY||LS means difference|2.01|||<|0.001|TWO_SIDED|95.0|1.69|2.33|||ANCOVA|||PRR score at 1 hour||2.33|1.69|< 0.001
71941231|NCT02863575|143403654|SUPERIORITY||LS means difference|1.78|||<|0.001|TWO_SIDED|95.0|1.46|2.09|||ANCOVA|||PRR score at 1 hour||2.09|1.46|< 0.001
71941232|NCT02863575|143403654|SUPERIORITY||LS means difference|0.25||||0.024|TWO_SIDED|95.0|0.03|0.47|||ANCOVA|||PRR score at 1.5 hour||0.47|0.03|0.024
71941233|NCT02863575|143403654|SUPERIORITY||LS means difference|2.33|||<|0.001|TWO_SIDED|95.0|2.02|2.64|||ANCOVA|||PRR score at 1.5 hour||2.64|2.02|< 0.001
71941234|NCT02863575|143403654|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.77|2.39|||ANCOVA|||PRR score at 1.5 hour||2.39|1.77|< 0.001
71941235|NCT02863575|143403654|SUPERIORITY||LS means difference|0.18||||0.103|TWO_SIDED|95.0|-0.04|0.4|||ANCOVA|||PRR score at 2 hour||0.40|-0.04|0.103
71941236|NCT02863575|143403654|SUPERIORITY||LS means difference|2.4|||<|0.001|TWO_SIDED|95.0|2.09|2.71|||ANCOVA|||PRR score at 2 hour||2.71|2.09|< 0.001
71941237|NCT02863575|143403654|SUPERIORITY||LS means difference|2.22|||<|0.001|TWO_SIDED|95.0|1.91|2.53|||ANCOVA|||PRR score at 2 hour||2.53|1.91|< 0.001
71941238|NCT02863575|143403654|SUPERIORITY||LS means difference|0.08||||0.448|TWO_SIDED|95.0|-0.13|0.29|||ANCOVA|||PRR score at 3 hour||0.29|-0.13|0.448
71941239|NCT02863575|143403654|SUPERIORITY||LS means difference|2.16|||<|0.001|TWO_SIDED|95.0|1.86|2.47|||ANCOVA|||PRR score at 3 hour||2.47|1.86|< 0.001
71941240|NCT02863575|143403654|SUPERIORITY||LS means difference|2.08|||<|0.001|TWO_SIDED|95.0|1.78|2.38|||ANCOVA|||PRR score at 3 hour||2.38|1.78|< 0.001
71941241|NCT02863575|143403654|SUPERIORITY||LS means difference|0.0||||0.997|TWO_SIDED|95.0|-0.23|0.23|||ANCOVA|||PRR score at 4 hour||0.23|-0.23|0.997
71941242|NCT02863575|143403654|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
71941243|NCT02863575|143403654|SUPERIORITY||LS means difference|1.94|||<|0.001|TWO_SIDED|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour||2.28|1.61|< 0.001
71941244|NCT02863575|143403654|SUPERIORITY||LS means difference|0.06||||0.656|TWO_SIDED|95.0|-0.19|0.31|||ANCOVA|||PRR score at 5 hour||0.31|-0.19|0.656
71941245|NCT02863575|143403654|SUPERIORITY||LS means difference|1.73|||<|0.001|TWO_SIDED|95.0|1.36|2.09|||ANCOVA|||PRR score at 5 hour||2.09|1.36|< 0.001
71941246|NCT02863575|143403654|SUPERIORITY||LS means difference|1.67|||<|0.001|TWO_SIDED|95.0|1.31|2.03|||ANCOVA|||PRR score at 5 hour||2.03|1.31|< 0.001
71941247|NCT02863575|143403654|SUPERIORITY||LS means difference|0.11||||0.425|TWO_SIDED|94.0|-0.16|0.38|||ANCOVA|||PRR score at 6 hour||0.38|-0.16|0.425
71693628|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|5.9||0.8096||95.0|-10.2|13.0|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||13.0|-10.2|0.8096
71693629|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.6|STANDARD_ERROR_OF_MEAN|6.01||0.0157||95.0|-26.5|-2.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-2.8|-26.5|0.0157
71693630|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.0|STANDARD_ERROR_OF_MEAN|5.79||0.6007||95.0|-14.4|8.4|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||8.4|-14.4|0.6007
71693631|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.0|STANDARD_ERROR_OF_MEAN|6.15||0.1057||95.0|-22.1|2.1|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.1|-22.1|0.1057
71693632|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|5.81||0.7764||95.0|-13.1|9.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-13.1|0.7764
71693633|NCT00676403|142901938|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|5.93||0.7146||95.0|-13.9|9.5|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.5|-13.9|0.7146
71693634|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.2978||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.2978
71693635|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7242||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7242
71941248|NCT02863575|143403654|SUPERIORITY||LS means difference|1.51|||<|0.001|TWO_SIDED|95.0|1.12|1.9|||ANCOVA|||PRR score at 6 hour||1.90|1.12|< 0.001
71693636|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.32||0.0773||95.0|-0.1|1.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.1|0.0773
71693637|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7831||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7831
71693638|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.3291||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3291
71693639|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.3692||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.3|0.3692
71941249|NCT02863575|143403654|SUPERIORITY||LS means difference|1.4|||<|0.001|TWO_SIDED|95.0|1.01|1.79|||ANCOVA|||PRR score at 6 hour||1.79|1.01|< 0.001
71941250|NCT02863575|143403654|SUPERIORITY||LS means difference|-0.03||||0.841|TWO_SIDED|95.0|-0.32|0.26|||ANCOVA|||PRR score at 7 hour||0.26|-0.32|0.841
71941251|NCT02863575|143403654|SUPERIORITY||LS means difference|1.1|||<|0.001|TWO_SIDED|95.0|0.69|1.52|||ANCOVA|||PRR score at 7 hour||1.52|0.69|< 0.001
71941252|NCT02863575|143403654|SUPERIORITY||LS means difference|1.13|||<|0.001|TWO_SIDED|95.0|0.72|1.55|||ANCOVA|||PRR score at 7 hour||1.55|0.72|< 0.001
71941253|NCT02863575|143403654|SUPERIORITY||LS means difference|0.0||||0.98||95.0|-0.3|0.3|||ANCOVA|||PRR score at 8 hour||0.30|-0.30|0.980
71693640|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7614||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7614
71693641|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0355||95.0|0.0|1.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0355
71693642|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.3||0.5068||95.0|-0.4|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.8|-0.4|0.5068
71693643|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0561||95.0|0.0|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0561
71693644|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.31||0.2223||95.0|-0.2|1.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.0|-0.2|0.2223
71693645|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.6791||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.6791
71693646|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.32||0.0188||95.0|0.1|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.4|0.1|0.0188
71693647|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.3||0.1314||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.1314
71693648|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.31||0.09||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.1|-0.1|0.0900
71693649|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.31||0.4144||95.0|-0.4|0.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.9|-0.4|0.4144
71693650|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7699||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7699
71693651|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.32||0.0406||95.0|0.0|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|0.0|0.0406
71693652|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.3||0.7574||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.7|-0.5|0.7574
71941254|NCT02863575|143403654|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.36|||ANCOVA|||PRR score at 8 hour||1.36|0.50|< 0.001
71941255|NCT02863575|143403654|SUPERIORITY||LS means difference|0.93|||<|0.001|TWO_SIDED|95.0|0.5|1.35|||ANCOVA|||PRR score at 8 hour||1.35|0.50|< 0.001
71941256|NCT02863575|143403655|SUPERIORITY||LS means difference|-0.03||||0.808|TWO_SIDED|95.0|-0.27|0.21|||ANCOVA|||PID score at 0.25 hour||0.21|-0.27|0.808
71693653|NCT00676403|142901939|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.31||0.0554||95.0|0.0|1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-0.0|0.0554
71693654|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.36||0.5409||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5409
71761139|NCT01039376|143023906|SUPERIORITY||Hazard Ratio (HR)|1.301|||||TWO_SIDED|95.0|0.692|2.448|||||HR estimated for VH3-21 Usage Flag Yes/No.|||2.448|0.692|
71941257|NCT02863575|143403655|SUPERIORITY||LS means difference|0.04||||0.804|TWO_SIDED|95.0|-0.3|0.39|||ANCOVA|||PID score at 0.25 hour||0.39|-0.30|0.804
71941258|NCT02863575|143403655|SUPERIORITY||LS means difference|0.07||||0.676|TWO_SIDED|95.0|-0.27|0.42|||ANCOVA|||PID score at 0.25 hr||0.42|-0.27|0.676
71941259|NCT02863575|143403655|SUPERIORITY||LS means difference|-0.1||||0.654|TWO_SIDED|95.0|-0.55|0.35|||ANCOVA|||PID score at 0.5 hour||0.35|-0.55|0.654
71941260|NCT02863575|143403655|SUPERIORITY||LS means difference|1.45|||<|0.001|TWO_SIDED|95.0|0.81|2.1|||ANCOVA|||PID score at 0.5 hour||2.10|0.81|< 0.001
71941261|NCT02863575|143403655|SUPERIORITY||LS means difference|1.55|||<|0.001|TWO_SIDED|95.0|0.91|2.2|||ANCOVA|||PID score at 0.5 hour||2.20|0.91|< 0.001
71941262|NCT02863575|143403655|SUPERIORITY||LS means difference|0.49||||0.045|TWO_SIDED|95.0|0.01|0.97|||ANCOVA|||PID score at 1 hour||0.97|0.01|0.045
71941263|NCT02863575|143403655|SUPERIORITY||LS means difference|4.1|||<|0.001||95.0|3.41|4.78|||ANCOVA|||PID score at 1 hour||4.78|3.41|< 0.001
71941264|NCT02863575|143403655|SUPERIORITY||LS means difference|3.6|||<|0.001|TWO_SIDED|95.0|2.92|4.29|||ANCOVA|||PID score at 1 hour||4.29|2.92|< 0.001
71941265|NCT02863575|143403655|SUPERIORITY||LS means difference|0.59||||0.015|TWO_SIDED|95.0|0.11|1.06|||ANCOVA|||PID score at 1.5 hour||1.06|0.11|0.015
71941266|NCT02863575|143403655|SUPERIORITY||LS means difference|5.03|||<|0.001|TWO_SIDED|95.0|4.35|5.71|||ANOVA|||PID score at 1.5 hour||5.71|4.35|< 0.001
71941267|NCT02863575|143403655|SUPERIORITY||LS means difference|4.44|||<|0.001|TWO_SIDED|95.0|3.76|5.12|||ANCOVA|||PID score at 1.5 hour||5.12|3.76|< 0.001
71693655|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|5.25||0.823||95.0|-11.5|9.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.2|-11.5|0.8230
71693656|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7|STANDARD_ERROR_OF_MEAN|5.48||0.2958||95.0|-16.5|5.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.5|0.2958
71941268|NCT02863575|143403655|SUPERIORITY||LS means difference|0.44||||0.066|TWO_SIDED|95.0|-0.03|0.91|||ANCOVA|||PID score at 2 hour||0.91|-0.03|0.066
71941269|NCT02863575|143403655|SUPERIORITY||LS means difference|5.22|||<|0.001|TWO_SIDED|95.0|4.54|5.89|||ANCOVA|||PID score at 2 hour||5.89|4.54|< 0.001
71941270|NCT02863575|143403655|SUPERIORITY||LS means difference|4.78|||<|0.001|TWO_SIDED|95.0|4.1|5.45|||ANCOVA|||PID score at 2 hour||5.45|4.10|< 0.001
71693657|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.7|STANDARD_ERROR_OF_MEAN|5.27||0.3708||95.0|-15.1|5.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.7|-15.1|0.3708
71693658|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.27||0.1853||95.0|-17.4|3.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.4|0.1853
71693659|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.41||0.1834||95.0|-17.9|3.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.4|-17.9|0.1834
71693660|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.22||0.8711||95.0|-11.1|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.4|-11.1|0.8711
71693661|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.5||0.3252||95.0|-16.3|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.4|-16.3|0.3252
71693662|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.3|STANDARD_ERROR_OF_MEAN|5.28||0.3205||95.0|-15.7|5.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-15.7|0.3205
71693663|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|STANDARD_ERROR_OF_MEAN|5.34||0.0837||95.0|-19.8|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.2|-19.8|0.0837
71693664|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.8|STANDARD_ERROR_OF_MEAN|5.4||0.8895||95.0|-11.4|9.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.9|-11.4|0.8895
71941271|NCT02863575|143403655|SUPERIORITY||LS means difference|0.32||||0.186|TWO_SIDED|95.0|-0.16|0.81|||ANCOVA|||PID score at 3 hour||0.81|-0.16|0.186
71693665|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.4|STANDARD_ERROR_OF_MEAN|5.22||0.6469||95.0|-12.7|7.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.9|-12.7|0.6469
71693666|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.53||0.2687||95.0|-17.0|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-17.0|0.2687
71693667|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.2|STANDARD_ERROR_OF_MEAN|5.31||0.1757||95.0|-17.7|3.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.3|-17.7|0.1757
71693668|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.7|STANDARD_ERROR_OF_MEAN|5.38||0.0306||95.0|-22.3|-1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.1|-22.3|0.0306
71693669|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.4|STANDARD_ERROR_OF_MEAN|5.47||0.0857||95.0|-20.2|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.2|0.0857
71941272|NCT02863575|143403655|SUPERIORITY||LS means difference|4.66|||<|0.001|TWO_SIDED|95.0|3.98|5.35|||ANCOVA|||PID score at 3 hour||5.35|3.98|< 0.001
71941273|NCT02863575|143403655|SUPERIORITY||LS means difference|4.34|||<|0.001|TWO_SIDED|95.0|3.65|5.03|||ANCOVA|||PID score at 3 hour||5.03|3.65|< 0.001
71941274|NCT02863575|143403655|SUPERIORITY||LS means difference|0.08||||0.75|TWO_SIDED|95.0|-0.43|0.6|||ANCOVA|||PID score at 4 hour||0.60|-0.43|0.750
71941275|NCT02863575|143403655|SUPERIORITY||LS means difference|4.14|||<|0.001|TWO_SIDED|95.0|3.4|4.87|||ANCOVA|||PID score at 4 hour||4.87|3.40|< 0.001
71941276|NCT02863575|143403655|SUPERIORITY||LS means difference|4.05|||<|0.001|TWO_SIDED|95.0|3.32|4.79|||ANCOVA|||PID score at 4 hour||4.79|3.32|< 0.001
71941277|NCT02863575|143403655|SUPERIORITY||LS means difference|0.26||||0.361|TWO_SIDED|95.0|-0.3|0.81|||ANCOVA|||PID score at 5 hour||0.81|-0.30|0.361
71941278|NCT02863575|143403655|SUPERIORITY||LS means difference|3.74|||<|0.001|TWO_SIDED|95.0|2.95|4.53|||ANCOVA|||PID score at 5 hour||4.53|2.95|< 0.001
71941279|NCT02863575|143403655|SUPERIORITY||LS means difference|3.48|||<|0.001|TWO_SIDED|95.0|2.69|4.27|||ANCOVA|||PID score at 5 hour||4.27|2.69|< 0.001
71941280|NCT02863575|143403655|SUPERIORITY||LS means difference|0.39||||0.195|TWO_SIDED|95.0|-0.2|0.98|||ANCOVA|||PID score at 6 hour||0.98|-0.20|0.195
71941281|NCT02863575|143403655|SUPERIORITY||LS means difference|3.29|||<|0.001|TWO_SIDED|95.0|2.44|4.13|||ANCOVA|||PID score at 6 hour||4.13|2.44|< 0.001
71941282|NCT02863575|143403655|SUPERIORITY||LS means difference|2.9|||<|0.001|TWO_SIDED|95.0|2.06|3.74|||ANCOVA|||PID score at 6 hour||3.74|2.06|< 0.001
71941283|NCT02863575|143403655|SUPERIORITY||LS means difference|0.14||||0.669|TWO_SIDED|95.0|-0.49|0.76|||ANCOVA|||PID score at 7 hour||0.76|-0.49|0.669
71941284|NCT02863575|143403655|SUPERIORITY||LS means difference|2.42|||<|0.001|TWO_SIDED|95.0|1.53|3.31|||ANCOVA|||PID score at 7 hour||3.31|1.53|< 0.001
71693670|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.6|STANDARD_ERROR_OF_MEAN|5.28||0.2932||95.0|-16.0|4.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.8|-16.0|0.2932
71941285|NCT02863575|143403655|SUPERIORITY||LS means difference|2.29|||<|0.001|TWO_SIDED|95.0|1.4|3.18|||ANCOVA|||PID score at 7 hour||3.18|1.40|< 0.001
71941286|NCT02863575|143403655|SUPERIORITY||LS means difference|0.18||||0.581|TWO_SIDED|95.0|-0.46|0.82|||ANCOVA|||PID score at 8 hour||0.82|-0.46|0.581
71941287|NCT02863575|143403655|SUPERIORITY||LS means difference|2.09|||<|0.001|TWO_SIDED|95.0|1.18|3.0|||ANCOVA|||PID score at 8 hour||3.00|1.18|< 0.001
71941288|NCT02863575|143403655|SUPERIORITY||LS means difference|1.91|||<|0.001|TWO_SIDED|95.0|1.0|2.82|||ANCOVA|||PID score at 8 hour||2.82|1.00|< 0.001
71941289|NCT02863575|143403656|SUPERIORITY|||||||0.028|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.028
71941290|NCT02863575|143403656|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71941291|NCT02863575|143403656|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71941292|NCT02863575|143403657|SUPERIORITY|||||||0.861|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.861
71941293|NCT02863575|143403657|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71941294|NCT02863575|143403657|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71941295|NCT02863575|143403658|SUPERIORITY|||||||0.838|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||0.838
71941296|NCT02863575|143403658|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71941297|NCT02863575|143403658|SUPERIORITY||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.||||||<0.001
71941298|NCT03900624|143403667|SUPERIORITY|||||||0.632|||||||Wilcoxon (Mann-Whitney)|||||||0.632
71941299|NCT03900624|143403668|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
71941300|NCT03900624|143403669|SUPERIORITY|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||||||0.725
71941301|NCT01494506|143403682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.9416|TWO_SIDED|95.0|0.77|1.28|||Log Rank|Unstratified logrank test.||||1.28|0.77|0.9416
71941302|NCT01494506|143403682|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.67||||0.012|TWO_SIDED|95.0|0.49|0.92|||Log Rank|Unstratified logrank test.||||0.92|0.49|0.012
71941303|NCT01494506|143403683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.81||||0.1|TWO_SIDED|95.0|0.63|1.04|||Log Rank|||||1.04|0.63|0.100
71941304|NCT01494506|143403683|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.56|||<|0.001|TWO_SIDED|95.0|0.41|0.75|||Log Rank|||||0.75|0.41|<0.001
71941305|NCT01494506|143403684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0264||||0.214|TWO_SIDED|95.0|-0.005|0.058|||Fisher Exact|||||0.058|-0.005|0.214
71941306|NCT01494506|143403684|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.069||||0.01|TWO_SIDED|95.0|0.018|0.12|||Fisher Exact|||||0.120|0.018|0.010
71941307|NCT01494506|143403685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.82||||0.1008|TWO_SIDED|95.0|0.65|1.03|||Log Rank|Unstratified log rank test.||||1.03|0.65|0.1008
71941308|NCT01494506|143403685|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.6||||0.0002|TWO_SIDED|95.0|0.45|0.78|||Log Rank|Unstratified log rank test||||0.78|0.45|0.0002
71941309|NCT01494506|143403686|SUPERIORITY_OR_OTHER|||||||0.82|||||||Fisher Exact|||||||0.82
71941310|NCT01494506|143403686|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.80
71941311|NCT01494506|143403687|SUPERIORITY_OR_OTHER|||||||0.024|||||||Fisher Exact|||||||0.024
71941312|NCT01494506|143403687|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Fisher Exact|||||||<0.001
71941313|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.6388
71941314|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.8445||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status||||0.8445
71941315|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.6388
71941316|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.9435||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning||||0.9435
71941317|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.2654
71941318|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning||||0.7674
71941319|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.1628
71941320|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning||||0.6712
71941321|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.7738||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.7738
71941322|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning||||0.6712
71941323|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.3408||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.3408
71941324|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning||||0.6712
71941325|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6766||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6766
71941326|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue||||0.6712
71941327|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.6388
71941328|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting||||0.7674
71941329|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.4993||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.4993
71941330|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain||||0.6712
71941331|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.2654
71941332|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea||||0.6712
71941333|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.7617
71941334|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712|||||||Cochran-Mantel-Haenszel|||Comparison of Insomnia||||0.6712
71941335|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.9123||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.9123
71941336|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss||||0.6712
71941337|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.7617
71941338|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation||||0.6712
71941339|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.1628
71941340|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea||||0.6712
71693671|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.5|STANDARD_ERROR_OF_MEAN|5.6||0.0613||95.0|-21.6|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.5|-21.6|0.0613
71693672|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.3|STANDARD_ERROR_OF_MEAN|5.34||0.5431||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||7.3|-13.8|0.5431
71941341|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.6388
71941342|NCT01494506|143403688|SUPERIORITY_OR_OTHER|||||||0.7308||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties||||0.7308
71941343|NCT02777528|143403690|OTHER|Performance goal tested using Exact method calculation to estimate the 95% one-sided lower confidence level (95% LCL) on the proportion of participants with primary endpoint success. If the 95% LCL exceeded 0.60, then the null hypothesis was to be rejected and the PG was met.|95% Exact Lower Confidence Limit|0.745|||||TWO_SIDED|||||||||"Primary endpoint success was defined as the proportion of analysis-eligible participants without a primary endpoint event and with 1-Month imaging performed.~Results were tested against a performance goal (PG) of 0.60 (i.e. 60%), derived from outcomes from a systematic review of hybrid TEVAR repair literature.~Additionally, using a one-sided alpha of 0.05 and Exact Test, minimum power of 80%, the sample needed was 50 patients."||||
71941344|NCT01492361|143403692|SUPERIORITY||Hazard Ratio (HR)|0.75||||1e-08|TWO_SIDED|95.0|0.68|0.83||The 2-sided alpha level for the primary analysis was adjusted to 0.0437 from 0.05 to account for the two interim analyses based on a group sequential design with O'Brien-Fleming boundaries generated using the Lan-DeMets alpha-spending function.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region||||0.83|0.68|0.00000001
71941345|NCT01492361|143403693|SUPERIORITY||Hazard Ratio (HR)|0.74||||6e-07|TWO_SIDED|95.0|0.65|0.83||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.83|0.65|0.0000006
71941346|NCT01492361|143403694|SUPERIORITY||Hazard Ratio (HR)|0.75|||<|0.0001|TWO_SIDED|95.0|0.66|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.66|<0.0001
71941347|NCT01492361|143403695|SUPERIORITY||Hazard Ratio (HR)|0.69|||<|0.0001|TWO_SIDED|95.0|0.58|0.81||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.81|0.58|<0.0001
71941348|NCT01492361|143403696|SUPERIORITY||Hazard Ratio (HR)|0.65|||<|0.0001|TWO_SIDED|95.0|0.55|0.78||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.78|0.55|<0.0001
71693673|NCT00676403|142901940|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|5.41||0.0262||95.0|-22.7|-1.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.4|-22.7|0.0262
71693674|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.44||0.1547||95.0|-18.5|3.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||3.0|-18.5|0.1547
71941349|NCT01492361|143403697|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0315|TWO_SIDED|95.0|0.66|0.98||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.98|0.66|0.0315
71941350|NCT01492361|143403698|SUPERIORITY||Hazard Ratio (HR)|0.68||||0.0018|TWO_SIDED|95.0|0.53|0.87||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.87|0.53|0.0018
71941351|NCT01492361|143403699|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0129|TWO_SIDED|95.0|0.55|0.93||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.93|0.55|0.0129
71941352|NCT01492361|143403700|SUPERIORITY||Hazard Ratio (HR)|0.77|||<|0.0001|TWO_SIDED|95.0|0.69|0.86||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||0.86|0.69|<0.0001
71941353|NCT01492361|143403701|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0915|TWO_SIDED|95.0|0.74|1.02||Prespecified secondary end points were tested in a hierarchical fashion, in the order listed here, at the final alpha level of 0.0437.|Log Rank|Stratified by CV risk category, use of ezetimibe, and geographical region.||||1.02|0.74|0.0915
71693675|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.1|STANDARD_ERROR_OF_MEAN|5.33||0.2532||95.0|-16.6|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.4|-16.6|0.2532
71693676|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.6|STANDARD_ERROR_OF_MEAN|5.56||0.0848||95.0|-20.6|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.3|-20.6|0.0848
71693677|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|5.36||0.2424||95.0|-16.8|4.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.3|-16.8|0.2424
71693678|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.35||0.047||95.0|-21.2|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.2|0.0470
71941354|NCT00023309|143403730|SUPERIORITY_OR_OTHER|||||||0.0294||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in the treatment effect between the two groups||||0.0294
71941355|NCT00023309|143403731|SUPERIORITY_OR_OTHER|||||||0.0325||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0325
71693679|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.9|STANDARD_ERROR_OF_MEAN|5.49||0.1494||95.0|-18.8|2.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.9|-18.8|0.1494
71941356|NCT00023309|143403732|SUPERIORITY_OR_OTHER|||||||0.0049||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0049
71761140|NCT04954833|143023925|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR. A value of 0.05 logMAR is approximately 2.5 letters on the ETDRS chart.|LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|-0.01|0.02|||Mixed Model Analysis|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test - Control|||0.02|-0.01|
71941357|NCT00023309|143403733|SUPERIORITY_OR_OTHER|||||||0.0157||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0157
71941358|NCT00023309|143403734|SUPERIORITY_OR_OTHER|||||||0.0913||95.0|||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196||||0.0913
71941359|NCT03247556|143403735|SUPERIORITY||Least Square Mean Difference|-5.1|STANDARD_ERROR_OF_MEAN|1.93||0.0082|TWO_SIDED|95.0|-8.9|-1.3|||Mixed Model for Repeated Measures|||||-1.3|-8.9|0.0082
71941360|NCT03247556|143403735|SUPERIORITY||Least Square Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|1.93||0.0712|TWO_SIDED|95.0|-7.3|0.3|||Mixed Model for Repeated Measures|||||0.3|-7.3|0.0712
71941361|NCT03247556|143403736|SUPERIORITY||Least Square Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.17||0.0051|TWO_SIDED|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||-0.1|-0.8|0.0051
71941362|NCT03247556|143403736|SUPERIORITY||Least Square Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.17||0.0995|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|ANCOVA model with baseline Clinical Global Impression-Severity of Illness (CGI-S) score and treatment as fixed independent variables.||||0.1|-0.6|0.0995
71941363|NCT03247556|143403737|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|1.26||0.1377|TWO_SIDED|95.0|-4.3|0.6|||ANCOVA|||||0.6|-4.3|0.1377
71941364|NCT03247556|143403737|SUPERIORITY||Least Square Mean Difference|-1.3|STANDARD_ERROR_OF_MEAN|1.25||0.313|TWO_SIDED|95.0|-3.7|1.2|||ANCOVA|||||1.2|-3.7|0.3130
71941365|NCT03247556|143403738|SUPERIORITY||Least Square Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.049||0.0698|TWO_SIDED|95.0|-0.19|0.01|||ANCOVA|||||0.01|-0.19|0.0698
71941366|NCT03247556|143403738|SUPERIORITY||Least Square Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.05||0.9756|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|||||0.10|-0.10|0.9756
71941367|NCT03247556|143403739|SUPERIORITY||Risk Difference (RD)|15.3||||0.0349|TWO_SIDED|95.0|1.3|29.3|||Regression, Logistic|||||29.3|1.3|0.0349
71941368|NCT03247556|143403739|SUPERIORITY||Risk Difference (RD)|13.1||||0.0698|TWO_SIDED|95.0|-0.9|27.0|||Regression, Logistic|||||27.0|-0.9|0.0698
71941369|NCT03247556|143403740|SUPERIORITY||Least Square Mean Difference|-7.3|STANDARD_ERROR_OF_MEAN|4.76||0.1259|TWO_SIDED|95.0|-16.6|2.0|||ANCOVA|||||2.0|-16.6|0.1259
71941370|NCT03247556|143403740|SUPERIORITY||Least Square Mean Difference|1.6|STANDARD_ERROR_OF_MEAN|4.78||0.7417|TWO_SIDED|95.0|-7.8|10.9|||ANCOVA|||||10.9|-7.8|0.7417
71941371|NCT03247556|143403741|SUPERIORITY||Least Square Mean Difference|-1.9|STANDARD_ERROR_OF_MEAN|0.97||0.0484|TWO_SIDED|95.0|-3.8|0.0|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||-0.0|-3.8|0.0484
71693680|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|5.3||0.5081||95.0|-13.9|6.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.9|-13.9|0.5081
71693681|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.0|STANDARD_ERROR_OF_MEAN|5.58||0.2141||95.0|-17.9|4.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.0|-17.9|0.2141
71693682|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-7.8|STANDARD_ERROR_OF_MEAN|5.37||0.1484||95.0|-18.4|2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||2.8|-18.4|0.1484
71693683|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.0|STANDARD_ERROR_OF_MEAN|5.42||0.0963||95.0|-19.7|1.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.6|-19.7|0.0963
71693684|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|5.48||0.8519||95.0|-11.8|9.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||9.8|-11.8|0.8519
71693685|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.8|STANDARD_ERROR_OF_MEAN|5.3||0.477||95.0|-14.2|6.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||6.7|-14.2|0.4770
71693686|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|5.61||0.2166||95.0|-18.0|4.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||4.1|-18.0|0.2166
71693687|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.8|STANDARD_ERROR_OF_MEAN|5.4||0.1062||95.0|-19.4|1.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||1.9|-19.4|0.1062
71693688|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|STANDARD_ERROR_OF_MEAN|5.45||0.0475||95.0|-21.6|-0.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.1|-21.6|0.0475
71693689|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.7|STANDARD_ERROR_OF_MEAN|5.54||0.0537||95.0|-21.7|0.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||0.2|-21.7|0.0537
71693690|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.4|STANDARD_ERROR_OF_MEAN|5.35||0.3153||95.0|-15.9|5.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.2|-15.9|0.3153
71693691|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|STANDARD_ERROR_OF_MEAN|5.68||0.0424||95.0|-22.8|-0.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-0.4|-22.8|0.0424
71693692|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5|STANDARD_ERROR_OF_MEAN|5.42||0.3077||95.0|-16.2|5.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||5.1|-16.2|0.3077
71693693|NCT00676403|142901941|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-12.6|STANDARD_ERROR_OF_MEAN|5.48||0.0224||95.0|-23.4|-1.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).||-1.8|-23.4|0.0224
71941372|NCT03247556|143403741|SUPERIORITY||Least Square Mean Difference|-1.2|STANDARD_ERROR_OF_MEAN|0.96||0.2084|TWO_SIDED|95.0|-3.1|0.7|||ANCOVA|||This analysis pertains to the Hyperactivity/Impulsivity subscale score||0.7|-3.1|0.2084
71941373|NCT03247556|143403741|SUPERIORITY||Least Square Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.06||0.0042|TWO_SIDED|95.0|-5.1|-1.0|||ANCOVA|||This analysis pertains to the Inattention subscale score||-1.0|-5.1|0.0042
71941374|NCT03247556|143403741|SUPERIORITY||Least Square Mean Difference|-1.6|STANDARD_ERROR_OF_MEAN|1.06||0.1392|TWO_SIDED|95.0|-3.6|0.5|||ANCOVA|||This analysis pertains to the Inattention subscale score||0.5|-3.6|0.1392
71693694|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.7|STANDARD_ERROR_OF_MEAN|2.65||0.0646||95.0|0.9|15.0|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.0|0.9|0.0646
71693695|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.2|STANDARD_ERROR_OF_MEAN|1.58||0.2947||95.0|0.5|9.1|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||9.1|0.5|0.2947
71941375|NCT03247556|143403742|SUPERIORITY||Least Square Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.381|TWO_SIDED|95.0|-3.0|1.2|||ANCOVA|||||1.2|-3.0|0.3810
71693696|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|3.1||0.0249||95.0|1.2|17.2|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||17.2|1.2|0.0249
71941376|NCT03247556|143403742|SUPERIORITY||Least Square Mean Difference|-2.2|STANDARD_ERROR_OF_MEAN|1.08||0.0432|TWO_SIDED|95.0|-4.3|-0.1|||ANCOVA|||||-0.1|-4.3|0.0432
71693697|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.99||0.7671||95.0|0.3|5.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.9|0.3|0.7671
71941377|NCT03247556|143403743|SUPERIORITY|||||||0.1433|||||||Chi-squared|||This analysis pertains to Week 1||||0.1433
71941378|NCT03247556|143403743|SUPERIORITY|||||||0.0114|||||||Chi-squared|||This analysis pertains to Week 2||||0.0114
71941379|NCT03247556|143403743|SUPERIORITY|||||||0.0008|||||||Chi-squared|||This analysis pertains to Week 3||||0.0008
71941380|NCT03247556|143403743|SUPERIORITY|||||||0.0197|||||||Chi-squared|||This analysis pertains to Week 4||||0.0197
71941381|NCT03247556|143403743|SUPERIORITY|||||||0.0573|||||||Chi-squared|||This analysis pertains to Week 5||||0.0573
71941382|NCT03247556|143403743|SUPERIORITY|||||||0.0105|||||||Chi-squared|||This analysis pertains to Week 6||||0.0105
71941383|NCT03247556|143403743|SUPERIORITY|||||||0.0004|||||||Chi-squared|||This analysis pertains to Week 7||||0.0004
71941384|NCT03247556|143403743|SUPERIORITY|||||||0.2573|||||||Chi-squared|||This analysis pertains to Week 1||||0.2573
71941385|NCT03247556|143403743|SUPERIORITY|||||||0.165|||||||Chi-squared|||This analysis pertains to Week 2||||0.1650
71941386|NCT03247556|143403743|SUPERIORITY|||||||0.0372|||||||Chi-squared|||This analysis pertains to Week 3||||0.0372
71941387|NCT03247556|143403743|SUPERIORITY|||||||0.1711|||||||Chi-squared|||This analysis pertains to Week 4||||0.1711
71941388|NCT03247556|143403743|SUPERIORITY|||||||0.1428|||||||Chi-squared|||This analysis pertains to Week 5||||0.1428
71941389|NCT03247556|143403743|SUPERIORITY|||||||0.2148|||||||Chi-squared|||This analysis pertains to Week 6||||0.2148
71941390|NCT03247556|143403743|SUPERIORITY|||||||0.0662|||||||Chi-squared|||This analysis pertains to Week 7||||0.0662
71941391|NCT01682083|143403749|SUPERIORITY|Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.47|||<|0.0001|TWO_SIDED|95.0|0.39|0.58|||Log Rank|||The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.||0.58|0.39|< 0.0001
71941392|NCT01682083|143403750|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with dabrafenib + trametinib compared with Placebo.|Hazard Ratio, log|0.57||||0.006|TWO_SIDED|95.0|0.42|0.79|||Log Rank|the two-sided threshold for significance at this first interim analysis was p=0.000019||Hazard ratio is obtained from the stratified Pike estimator.||0.79|0.42|0.006
71941393|NCT01682083|143403751|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.51|||||TWO_SIDED|95.0|0.4|0.65||||||Hazard ratio is estimated using Pike estimator.||0.65|0.40|
71941394|NCT01682083|143403752|SUPERIORITY|A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio (HR)|0.47|||||TWO_SIDED|95.0|0.39|0.57||||||Hazard ratio is estimated using Pike estimator.||0.57|0.39|
71941395|NCT03952143|143403753|NON_INFERIORITY|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.07||||0.321|TWO_SIDED|95.0|-0.07|0.21|||Mixed Models Analysis|||||0.21|-0.07|0.321
71941396|NCT03952143|143403754|SUPERIORITY||LS Mean Difference|-14.6|||<|0.001|TWO_SIDED|95.0|-21.9|-7.4|||ANCOVA|||||-7.4|-21.9|<0.001
71941397|NCT03952143|143403755|SUPERIORITY||LS Mean Difference|-21.8|||<|0.001|TWO_SIDED|95.0|-30.9|-12.6|||ANCOVA|||||-12.6|-30.9|<0.001
71941398|NCT03952143|143403756|SUPERIORITY||Relative rate|0.26|||||TWO_SIDED|95.0|0.02|2.86||||||||2.86|0.02|
71941399|NCT03952143|143403757|SUPERIORITY||Relative rate|0.9|||||TWO_SIDED|95.0|0.49|1.66||||||For ≤30 minutes post meal||1.66|0.49|
71941400|NCT03952143|143403757|SUPERIORITY||Relative rate|1.35|||||TWO_SIDED|95.0|0.79|2.31||||||For ≤ 1 hour post meal||2.31|0.79|
71941401|NCT03952143|143403757|SUPERIORITY||Relative rate|1.6|||||TWO_SIDED|95.0|1.06|2.42||||||For \>1 to ≤2 hours post meal||2.42|1.06|
71941402|NCT03952143|143403757|SUPERIORITY||Relative rate|1.53|||||TWO_SIDED|95.0|1.05|2.23||||||For ≤2 hours post meal||2.23|1.05|
71941403|NCT03952143|143403757|SUPERIORITY||Relative rate|0.97|||||TWO_SIDED|95.0|0.69|1.39||||||For \>2 to ≤4 hours post meal||1.39|0.69|
71941404|NCT03952143|143403757|SUPERIORITY||Relative rate|1.15|||||TWO_SIDED|95.0|0.84|1.57||||||For ≤4 hours post meal||1.57|0.84|
71941405|NCT03952143|143403758|SUPERIORITY||LS Mean Difference|-0.29|||||TWO_SIDED|95.0|-1.1|0.53||||||||0.53|-1.10|
71941406|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|2.2|||||TWO_SIDED|95.0|-2.8|7.2||||||For Morning Premeal||7.2|-2.8|
71941407|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|-5.3|||||TWO_SIDED|95.0|-12.6|2.0||||||For Morning 1-hour Postmeal||2.0|-12.6|
71941408|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|-5.4|||||TWO_SIDED|95.0|-12.5|1.7||||||For Morning 2-hour Postmeal||1.7|-12.5|
71941409|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|4.2|||||TWO_SIDED|95.0|-1.8|10.1||||||For Midday Premeal||10.1|-1.8|
71941410|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|1.2|||||TWO_SIDED|95.0|-5.7|8.1||||||For Midday 1-hour Postmeal||8.1|-5.7|
71941411|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|1.9|||||TWO_SIDED|95.0|-5.1|8.9||||||For Midday 2-hour Postmeal||8.9|-5.1|
71941412|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|14.1|||||TWO_SIDED|95.0|7.6|20.6||||||For Evening Premeal||20.6|7.6|
71941413|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-5.1|9.1||||||For Evening 1-hour Postmeal||9.1|-5.1|
71941414|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|-0.2|||||TWO_SIDED|95.0|-7.3|6.8||||||For Evening 2-hour Postmeal||6.8|-7.3|
71941415|NCT03952143|143403759|SUPERIORITY||LS Mean Difference|1.7|||||TWO_SIDED|95.0|-4.7|8.1||||||For Bedtime||8.1|-4.7|
71941416|NCT03952143|143403760|SUPERIORITY||LS Mean Difference|2.8|||||TWO_SIDED|95.0|0.1|5.4||||||For Total Daily Insulin Dose||5.4|0.1|
71941417|NCT03952143|143403760|SUPERIORITY||LS Mean Difference|0.8|||||TWO_SIDED|95.0|0.0|1.5||||||For Daily Basal Insulin Dose||1.5|0.0|
71941418|NCT03952143|143403760|SUPERIORITY||LS Mean Difference|2.0|||||TWO_SIDED|95.0|-0.5|4.5||||||For Daily Prandial Insulin Dose||4.5|-0.5|
71941419|NCT03952143|143403761|SUPERIORITY||Odds Ratio (OR)|1.02||||0.924|TWO_SIDED|95.0|0.69|1.52|||Regression, Logistic|||For HbA1c \< 7%||1.52|0.69|0.924
71941420|NCT03952143|143403761|SUPERIORITY||Odds Ratio (OR)|0.98||||0.908|TWO_SIDED|95.0|0.64|1.49|||Regression, Logistic|||For HbA1c ≤6.5%||1.49|0.64|0.908
71941421|NCT01866319|143403762|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.46|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.46|<0.00001
71941422|NCT01866319|143403762|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.58|||<|1e-05|TWO_SIDED|95.0|0.47|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||0.72|0.47|<0.00001
71941423|NCT01866319|143403762|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.97||||0.75869|TWO_SIDED|95.0|0.77|1.21|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)||1.21|0.77|0.75869
71941424|NCT01866319|143403763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.00052|TWO_SIDED|95.0|0.47|0.83|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.83|0.47|0.00052
71941425|NCT01866319|143403763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.69||||0.00358|TWO_SIDED|95.0|0.52|0.9|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||0.90|0.52|0.00358
71941426|NCT01866319|143403763|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.91||||0.51319||95.0|0.67|1.22|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).||1.22|0.67|0.51319
71941427|NCT01866319|143403764|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|16.1||||0.00013|TWO_SIDED|95.0|7.8|24.5|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||24.5|7.8|0.00013
71941428|NCT01866319|143403764|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|17.2||||2e-05|TWO_SIDED|95.0|9.5|25.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||25.6|9.5|0.00002
71941429|NCT01866319|143403764|SUPERIORITY_OR_OTHER_LEGACY||Percent difference|-1.1||||0.82636||95.0|-10.6|8.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)||8.6|-10.6|0.82636
71941430|NCT04421508|143403767|SUPERIORITY||Odds Ratio (OR)|0.36||||0.6316|TWO_SIDED|95.0|||||Regression, Logistic|||||||0.6316
71941431|NCT04421508|143403767|SUPERIORITY||Odds Ratio (OR)|1.502||||0.4127|TWO_SIDED|95.0|0.567|3.977||Odds ratio, 95% CI and p-value are from a logistic regression model modelling the response using the covariates treatment, age, number of co-morbidities and baseline oxygem level|Regression, Logistic|||||3.977|0.567|0.4127
71941432|NCT04421508|143403775|SUPERIORITY|||||||0.6635|||||||Chi-squared|||||||0.6635
71941433|NCT03980483|143403777|SUPERIORITY||Odds Ratio (OR)|1.62||||0.0023|TWO_SIDED|0.95|1.19|2.21|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||2.21|1.19|0.0023
71941434|NCT03980483|143403777|SUPERIORITY||Odds Ratio (OR)|1.39||||0.0362|TWO_SIDED|0.95|1.02|1.89|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||1.89|1.02|0.0362
71941435|NCT03980483|143403777|SUPERIORITY||Odds Ratio (OR)|2.34|||<|0.0001|TWO_SIDED|0.95|1.62|3.37|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 05mg dose of Tofacitinib and placebo in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 05mg dose of Tofacitinib differs from placebo in the proportion of participants achieving ACR20 response at Week 12.||3.37|1.62|<0.0001
71941436|NCT03980483|143403777|SUPERIORITY||Odds Ratio (OR)|0.69||||0.023|TWO_SIDED|0.95|0.5|0.95|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 90mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 90mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.95|0.50|0.0230
71941437|NCT03980483|143403777|SUPERIORITY||Odds Ratio (OR)|0.59||||0.0013|TWO_SIDED|0.95|0.43|0.82|||Regression, Logistic|OR and corresponding 95% CI for OR are generated from the logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||The null hypothesis is defined as there is no difference between the 150mg dose of GSK3196165 and 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12, versus the alternative hypothesis that the 150mg dose of GSK3196165 differs from 05mg dose of Tofacitinib in the proportion of participants achieving ACR20 response at Week 12.||0.82|0.43|0.0013
71941438|NCT03980483|143403780|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5 % Confidence Interval (CI) in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-10.4|||||TWO_SIDED|0.975|-18.6|-2.3|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-2.3|-18.6|
71941439|NCT03980483|143403780|NON_INFERIORITY|Non-inferiority over tofacitinib on ACR20 was concluded if the lower limit of the multiplicity corrected 97.5% CI in the difference in proportions (GSK3196165 minus tofacitinib) was greater than -12%|Mean Difference (Final Values)|-13.0|||||TWO_SIDED|0.975|-21.2|-4.8|||Regression, Logistic|Difference in proportion and 97.5% CI are generated from logistic regression model adjusted for Baseline TJC68, Baseline SJC66 and Treatment Group.||||-4.8|-21.2|
71941440|NCT03249584|143404097|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.||||<0.0001
71693698|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.6|STANDARD_ERROR_OF_MEAN|2.9||0.0169||95.0|1.3|15.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.9|1.3|0.0169
71941441|NCT00659607|143404101|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
71941442|NCT00659607|143404102|SUPERIORITY_OR_OTHER|||||||0.2669|||||||Chi-squared|||||||0.2669
71941443|NCT00659607|143404103|SUPERIORITY_OR_OTHER|||||||0.9674|||||||Chi-squared|||||||0.9674
71941444|NCT00659607|143404104|SUPERIORITY_OR_OTHER|||||||0.9207|||||||Chi-squared|||||||0.9207
71941445|NCT00659607|143404105|SUPERIORITY_OR_OTHER|||||||0.8249|||||||Fisher Exact|||||||0.8249
71941446|NCT00659607|143404106|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test for paired observations|||||||<0.0001
71693699|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.74||0.9569||95.0|0.2|4.3|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.3|0.2|0.9569
71693700|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|3.2|STANDARD_ERROR_OF_MEAN|2.07||0.0711||95.0|0.9|11.4|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||11.4|0.9|0.0711
71693701|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.8|STANDARD_ERROR_OF_MEAN|1.85||0.1073||95.0|0.8|10.2|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||10.2|0.8|0.1073
71693702|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.4|STANDARD_ERROR_OF_MEAN|1.48||0.1583||95.0|0.7|8.1|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||8.1|0.7|0.1583
71693703|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.1|STANDARD_ERROR_OF_MEAN|2.8||0.0385||95.0|1.1|15.6|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||15.6|1.1|0.0385
71693704|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.09||0.4923||95.0|0.4|6.1|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.1|0.4|0.4923
71693705|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.8||0.7169||95.0|0.4|4.4|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.4|0.4|0.7169
71693706|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.12||0.4156||95.0|0.5|6.2|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.2|0.5|0.4156
71693707|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.04||0.4165||95.0|0.5|5.6|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||5.6|0.5|0.4165
71693708|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.6|STANDARD_ERROR_OF_MEAN|1.08||0.4673||95.0|0.4|6.0|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.0|0.4|0.4673
71693709|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.72||0.9855||95.0|0.2|4.1|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||4.1|0.2|0.9855
71941447|NCT00659607|143404108|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.2||||0.0003|TWO_SIDED|95.0|1.121|4.151|||Chi-squared||The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis|||4.151|1.121|0.0003
71941448|NCT00659607|143404109|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.3|||<|0.0001|TWO_SIDED|95.0|1.642|6.776|||Chi-squared||The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis|||6.776|1.642|<0.0001
71941449|NCT00659607|143404110|SUPERIORITY_OR_OTHER|||||||0.0075|||||||Chi-squared|||||||0.0075
71941450|NCT00659607|143404111|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||||||0.0007
71941451|NCT00659607|143404112|SUPERIORITY_OR_OTHER|||||||0.0393|||||||Chi-squared|||||||0.0393
71941452|NCT00659607|143404113|SUPERIORITY_OR_OTHER|||||||0.0245|||||||Chi-squared|||||||0.0245
71941453|NCT00486837|143404120|SUPERIORITY_OR_OTHER|||||||0.197||95.0|||||ANCOVA|||||||0.197
71941454|NCT00262964|143404149|SUPERIORITY_OR_OTHER||||||<|0.019||95.0|||||t-test, 2 sided|||null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects||||<0.019
71941455|NCT00262964|143404150|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was P\<0.05.|t-test, 2 sided|||null hypothesis was that VLDL-TG production would not differ between the two groups.||||<0.001
71941456|NCT00262964|143404151|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|||null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.||||<0.001
71941457|NCT00262964|143404152|SUPERIORITY_OR_OTHER||||||<|0.002||95.0|||||t-test, 2 sided|||null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.||||<0.002
71693710|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|0.61||0.9566||95.0|0.3|3.3|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||3.3|0.3|0.9566
71693711|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.7|STANDARD_ERROR_OF_MEAN|1.17||0.4632||95.0|0.4|6.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||6.6|0.4|0.4632
71693712|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.4|STANDARD_ERROR_OF_MEAN|0.29||0.2042||95.0|0.1|1.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||1.6|0.1|0.2042
71693713|NCT00676403|142901942|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.9|STANDARD_ERROR_OF_MEAN|1.34||0.3382||95.0|0.5|7.5|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.||7.5|0.5|0.3382
71693714|NCT00676403|142901943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.6||||0.3932||95.0|-6.0|15.2|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.2|-6.0|0.3932
71693715|NCT00676403|142901943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1585||95.0|-2.9|17.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-2.9|0.1585
71693716|NCT00676403|142901943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.8||||0.285||95.0|-4.9|16.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||16.5|-4.9|0.2850
71693717|NCT00676403|142901943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8645||95.0|-9.4|11.1|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||11.1|-9.4|0.8645
71941458|NCT00262964|143404153|SUPERIORITY_OR_OTHER|||||||0.301||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||Student's t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.||||.301
71693718|NCT00676403|142901943|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.4||||0.3031||95.0|-5.0|15.8|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.||15.8|-5.0|0.3031
71693719|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5384||95.0|-13.2|7.0|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.0|-13.2|0.5384
71693720|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.2||||0.8015||95.0|-10.9|8.5|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.5|-10.9|0.8015
71693721|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.4429||95.0|-14.5|6.4|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.4|-14.5|0.4429
71693722|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.886||95.0|-10.5|9.1|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.1|-10.5|0.8860
71693723|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.0||||0.9963||95.0|-10.0|9.9|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.9|-10.0|0.9963
71693724|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.9||||0.3421||95.0|-6.3|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-6.3|0.3421
71693725|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2849||95.0|-5.4|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.1|-5.4|0.2849
71693726|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.6||||0.3058||95.0|-6.1|19.2|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|-6.1|0.3058
71941459|NCT00262964|143404153|SUPERIORITY_OR_OTHER|||||||0.315||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student's t-test was used.||A Student's t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.||||.315
71941460|NCT00262964|143404154|SUPERIORITY_OR_OTHER|||||||0.708||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||a Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.||||0.708
71941461|NCT00262964|143404154|SUPERIORITY_OR_OTHER|||||||0.022||95.0||||A P-value \< 0.05 was considered statistically significant.|t-test, 2 sided|||A Student's t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.||||.022
71941462|NCT00262964|143404155|SUPERIORITY_OR_OTHER|||||||0.02||95.0|||||t-test, 2 sided|||the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate||||.020
71941463|NCT00262964|143404155|SUPERIORITY_OR_OTHER|||||||0.358||95.0||||a priori threshold for significance was \<0.05.|t-test, 2 sided|||the null hypothesis was that niacin would not change the VLDL-Tg clearance rate||||.358
71941464|NCT00262964|143404156|SUPERIORITY_OR_OTHER|||||||0.758||95.0||||a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.||||0.758
71941465|NCT00262964|143404156|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||the a priori threshold for statistical significance was set at \<0.05.|t-test, 2 sided|||Null hypothesis is that niacin would not effect VLDL-Tg production rates.||||.023
71941466|NCT00262964|143404157|SUPERIORITY_OR_OTHER|||||||0.024||95.0||||the a priori threshold for statistical significance was p \<0.05|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.024
71941467|NCT00262964|143404157|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||the a priori threshold for statistical significance was p\<0.05|t-test, 2 sided|||The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||<0.001
71941468|NCT00262964|143404158|SUPERIORITY_OR_OTHER|||||||0.768||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.||||.768
71941469|NCT00262964|143404158|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||A priori threshold for significance was set for p\<0.05.|t-test, 2 sided|||Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin||||.019
71693727|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3||||0.9604||95.0|-12.1|11.5|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.5|-12.1|0.9604
71693728|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.5||||0.1661||95.0|-3.6|20.6|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.6|-3.6|0.1661
71941470|NCT00262964|143404159|SUPERIORITY_OR_OTHER|||||||0.318||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.||||.318
71941471|NCT00262964|143404159|SUPERIORITY_OR_OTHER|||||||0.025||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.||||.025
71941472|NCT00262964|143404160|SUPERIORITY_OR_OTHER|||||||0.419||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.||||.419
71941473|NCT00262964|143404160|SUPERIORITY_OR_OTHER|||||||0.018||95.0||||The a priori threshold for significance was set at p\<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.||||.018
71941474|NCT03130699|143404175|SUPERIORITY|||||||0.95|||||||Regression, Logistic|||Analyses controlled for age, gender, employment and language.||||0.95
71941475|NCT03130699|143404176|SUPERIORITY|||||||0.37|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.37
71941476|NCT03130699|143404177|SUPERIORITY|||||||0.26|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.26
71941477|NCT03130699|143404178|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.90
71941478|NCT03130699|143404179|SUPERIORITY|||||||0.21|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.21
71941479|NCT03130699|143404180|SUPERIORITY|||||||0.3|||||||Regression, Logistic|||Analyses controlled for age, gender, employment, and language.||||0.30
71941480|NCT03130699|143404181|SUPERIORITY|||||||0.9|||||||Regression, Logistic|||Analyses controlled for income.||||0.90
71941481|NCT03130699|143404182|SUPERIORITY|||||||0.72|||||||Regression, Logistic|||Analyses controlled for income.||||0.72
71693729|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.9||||0.1441||95.0|-3.1|20.9|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.9|-3.1|0.1441
71693730|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.0||||0.3076||95.0|-5.6|17.5|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.5|-5.6|0.3076
71941482|NCT03130699|143404183|SUPERIORITY|||||||0.61|||||||Regression, Logistic|||Analyses controlled for income.||||0.61
71941483|NCT03130699|143404184|SUPERIORITY|||||||0.49|||||||Regression, Logistic|||Analyses controlled for income.||||0.49
71941484|NCT03130699|143404185|SUPERIORITY|||||||0.96|||||||Regression, Logistic|||Analyses controlled for income.||||0.96
71941485|NCT03130699|143404186|SUPERIORITY|||||||0.64|||||||Regression, Logistic|||Analyses controlled for income.||||0.64
71941486|NCT03130699|143404187|SUPERIORITY|||||||0.87|||||||Regression, Logistic|||Binary logistic analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.87
71941487|NCT03130699|143404188|SUPERIORITY|||||||0.58|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.58
71941488|NCT03130699|143404189|SUPERIORITY|||||||0.25|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.25
71941489|NCT03130699|143404190|SUPERIORITY|||||||0.11|||||||Regression, Logistic|||Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.||||0.11
71941490|NCT03130699|143404191|SUPERIORITY|||||||0.76|||||||Regression, Logistic|||Analyses controlled for income.||||0.76
71941491|NCT03130699|143404192|SUPERIORITY|||||||0.05|||||||Regression, Logistic|||Analyses controlled for income.||||0.05
71941492|NCT03130699|143404193|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses controlled for income.||||0.63
71941493|NCT03130699|143404194|SUPERIORITY|||||||0.63|||||||Regression, Logistic|||Analyses is controlled for income.||||0.63
71941494|NCT03130699|143404195|SUPERIORITY|||||||0.002|||||||Regression, Logistic|||Analyses controlled for income.||||0.002
71941495|NCT03130699|143404196|SUPERIORITY|||||||0.008|||||||Regression, Logistic|||Analyses controlled for income.||||0.008
71941496|NCT01199861|143404201|SUPERIORITY_OR_OTHER||Percent Inhibition|41.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
71941497|NCT01199861|143404201|SUPERIORITY_OR_OTHER||Percent Inhibition|-35.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
71941498|NCT01199861|143404201|SUPERIORITY_OR_OTHER||Percent Inhibition|44.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.||||
71941499|NCT01199861|143404202|SUPERIORITY_OR_OTHER||Percent Inhibition|38.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
71941500|NCT01199861|143404202|SUPERIORITY_OR_OTHER||Percent Inhibition|-28.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
71941501|NCT01199861|143404202|SUPERIORITY_OR_OTHER||Percent Inhibition|48.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.||||
71941502|NCT00669864|143404213|SUPERIORITY_OR_OTHER||Estimated mean|-1.303|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001||95.0|-1.414|-1.192||A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.|t-test, 1 sided|||The null hypothesis (H0): HbA1c after 16 weeks - HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks - HbA1c at baseline \< 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease||-1.192|-1.414|<0.0001
71941503|NCT01822548|143404268|OTHER||||||<|0.05|||||||Regression, Linear|Generalized linear model (GLM)||||||<0.05
71693731|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.0||||0.1209||95.0|-2.7|22.7|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||22.7|-2.7|0.1209
71941504|NCT01822548|143404268|SUPERIORITY||Slope|0.362|||<|0.05|TWO_SIDED|95.0|0.028|0.695|||ANOVA|adjustment for baseline value of EPC||||0.695|0.028|<0.05
71941505|NCT01822548|143404269|SUPERIORITY||Slope|-0.067|||<|0.05|TWO_SIDED|95.0|-0.358|0.224|||ANOVA|||||0.224|-0.358|<0.05
71941506|NCT02809183|143404271|OTHER|Single-group test|Group LS mean|-0.2|STANDARD_ERROR_OF_MEAN|0.4||0.5547|TWO_SIDED|95.0|-0.9|0.5||The null hypothesis is that the mean change from baseline within the Pooled Placebo treatment group = 0 mEq/L.|Mixed Models Analysis|||||0.5|-0.9|0.5547
71941507|NCT02809183|143404271|OTHER|Single-group test|Group LS mean|3.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.4|4.0||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID group = 0 mEq/L|Mixed Models Analysis|||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.||4.0|2.4|< 0.0001
71941508|NCT02809183|143404271|OTHER|Single-group test|Group LS mean|3.0|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.2|3.8||The null hypothesis is the 3g TRC101 BID treatment group mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||3.8|2.2|< 0.0001
71941509|NCT02809183|143404271|OTHER|Single-group test|Group LS mean|3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.9|4.5||The null hypothesis is the 4.5g TRC101 BID treatment group mean change from baseline = 0 mEq/L|Mixed Models Analysis|||||4.5|2.9|< 0.0001
71941510|NCT02809183|143404272|OTHER|Two-group test|Difference between group LS means|3.4|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.3|4.5||The null hypothesis is the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.5|2.3|< 0.0001
71941511|NCT02809183|143404272|OTHER|Two-group test|Difference between group LS means|3.2|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.2|4.3||The null hypothesis is the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.3|2.2|< 0.0001
71941512|NCT02809183|143404272|OTHER|Two-group test|Difference between group LS means|3.9|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.9|5.0||The null hypothesis is the difference between the treatment groups (4.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||5.0|2.9|< 0.0001
71941513|NCT02809183|143404273|OTHER|Single-group test|Group LS mean|3.3|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|3.0|3.7||The null hypothesis is that the mean change from baseline within the Combined TRC101 treatment group = 0 mEq/L.|Mixed Models Analysis|||||3.7|3.0|< 0.0001
71941514|NCT02809183|143404274|OTHER|Two-group test|Difference between group LS means|3.6|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.8|4.4||The null hypothesis is that the difference between treatment groups (Combined TRC101 - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.4|2.8|< 0.0001
71941515|NCT02809183|143404275|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71941516|NCT02809183|143404275|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71941517|NCT02809183|143404275|OTHER|Two-group test||||||0.0074||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0074
71941518|NCT02809183|143404275|OTHER|Two-group test||||||0.0012||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||0.0012
71941519|NCT02809183|143404275|OTHER|Two-group test||||||0.0032||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0032
71941520|NCT02809183|143404275|OTHER|Two-group test||||||0.0013||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0013
71941521|NCT02809183|143404275|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71941522|NCT02809183|143404275|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71941523|NCT02809183|143404275|OTHER|Two-group test|||||<|0.0006||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||< 0.0006
71941524|NCT02809183|143404276|OTHER|Single-group test|Group LS mean|3.5|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|2.7|4.2||The null hypothesis is that the mean change from baseline within the 6g TRC101 QD group = 0 mEq/L.|Mixed Models Analysis|||||4.2|2.7|<0.0001
71941525|NCT02809183|143404277|OTHER|Two-group test|Difference between group LS means|3.7|STANDARD_ERROR_OF_MEAN|0.5|<|0.0001|TWO_SIDED|95.0|2.6|4.7||The null hypothesis is the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||4.7|2.6|<0.0001
71941526|NCT02809183|143404278|OTHER|Two-group test|Difference between group LS means|-0.5|STANDARD_ERROR_OF_MEAN|0.6||0.4214|TWO_SIDED|95.0|-1.6|0.7||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - 6g TRC101 QD) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis|||||0.7|-1.6|0.4214
71693732|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.4||||0.2791||95.0|-5.3|18.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||18.0|-5.3|0.2791
71693733|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.2||||0.0644||95.0|-0.7|23.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.7|0.0644
71693734|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.7544||95.0|-9.5|6.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||6.9|-9.5|0.7544
71693735|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.6||||0.5142||95.0|-10.3|5.2|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||5.2|-10.3|0.5142
71693736|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.8158||95.0|-7.4|9.4|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.4|-7.4|0.8158
71693737|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.9||||0.4599||95.0|-10.8|4.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||4.9|-10.8|0.4599
71693738|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.7||||0.8636||95.0|-8.7|7.3|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.3|-8.7|0.8636
71693739|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.5281||95.0|-7.8|15.1|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-7.8|0.5281
71693740|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.5||||0.6566||95.0|-8.5|13.5|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.5|-8.5|0.6566
71693741|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.1||||0.0677||95.0|-0.8|23.0|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||23.0|-0.8|0.0677
71693742|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.3||||0.4443||95.0|-6.8|15.4|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-6.8|0.4443
71693743|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|6.5||||0.2543||95.0|-4.7|17.7|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.7|-4.7|0.2543
71693744|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4||||0.9416||95.0|-11.0|11.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.9|-11.0|0.9416
71693745|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.5824||95.0|-14.1|7.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||7.9|-14.1|0.5824
71693746|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4||||0.5668||95.0|-15.3|8.4|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.4|-15.3|0.5668
71693747|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.6||||0.7769||95.0|-9.6|12.8|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-9.6|0.7769
71693748|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.1753||95.0|-3.5|19.1|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.1|-3.5|0.1753
71693749|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|8.7||||0.1508||95.0|-3.2|20.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||20.7|-3.2|0.1508
71941527|NCT02809183|143404279|OTHER|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 2 mEq/L = 0.|Fisher Exact|||||||< 0.0001
71693750|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.9||||0.0916||95.0|-1.6|21.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.4|-1.6|0.0916
71693751|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.1||||0.6222||95.0|-9.2|15.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.4|-9.2|0.6222
71941528|NCT02809183|143404279|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 3 mEq/L = 0.|Fisher Exact|||||||0.0003
71941529|NCT02809183|143404279|OTHER|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by =\> 4 mEq/L = 0.|Fisher Exact|||||||0.0003
71693752|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.2||||0.085||95.0|-1.4|21.8|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||21.8|-1.4|0.0850
71941530|NCT02545998|143404280|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||||||0.510
71941531|NCT02545998|143404281|SUPERIORITY|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71941532|NCT02545998|143404282|SUPERIORITY||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71941533|NCT02545998|143404283|SUPERIORITY|||||||0.589|||||||Wilcoxon (Mann-Whitney)|||||||0.589
71941534|NCT02545998|143404284|SUPERIORITY|||||||0.471|||||||Wilcoxon (Mann-Whitney)|||||||0.471
71941535|NCT02545998|143404285|SUPERIORITY|||||||0.264|||||||Sign test|||||||0.264
71941536|NCT04567342|143404302|SUPERIORITY||Risk Ratio (RR)|1.08||||0.531|TWO_SIDED|95.0|0.85|1.37|||Regression, Logistic||||Arm 3 vs. Arm 1|1.37|0.85|0.531
71941537|NCT04567342|143404302|SUPERIORITY||Risk Ratio (RR)|0.84||||0.189|TWO_SIDED|95.0|0.65|1.09|||Regression, Logistic||||Arm 2 vs. Arm 1|1.09|0.65|0.189
71941538|NCT04567342|143404302|SUPERIORITY||Risk Ratio (RR)|1.29||||0.054|TWO_SIDED|95.0|0.1|1.66|||Regression, Logistic||||Arm 3 vs. Arm 2|1.66|0.10|0.054
71941539|NCT04567342|143404302|SUPERIORITY||Risk Ratio (RR)|1.05||||0.654|TWO_SIDED|95.0|0.84|1.32|||Regression, Logistic||||Arm 4 vs. Arm 3|1.32|0.84|0.654
71941540|NCT04567342|143404302|SUPERIORITY||Risk Ratio (RR)|1.36||||0.018|TWO_SIDED|95.0|1.05|1.74|||Regression, Logistic||||Arm 4 vs. Arm 2|1.74|1.05|0.018
71941541|NCT04567342|143404302|SUPERIORITY||Risk Ratio (RR)|1.14||||0.283|TWO_SIDED|95.0|0.9|1.44|||Regression, Logistic||||Arm 4 vs. Arm 1|1.44|0.90|0.283
71941542|NCT04567342|143404303|SUPERIORITY||Risk Ratio (RR)|1.93|||<|0.01|TWO_SIDED|95.0|1.42|2.62|||Regression, Logistic||||Arm 3 vs. Arm 1|2.62|1.42|<0.01
71941543|NCT04567342|143404303|SUPERIORITY||Risk Ratio (RR)|0.82||||0.318|TWO_SIDED|95.0|0.56|1.21|||Regression, Logistic||||Arm 2 vs. Arm 1|1.21|0.56|0.318
71941544|NCT04567342|143404303|SUPERIORITY||Risk Ratio (RR)|2.34|||<|0.01|TWO_SIDED|95.0|1.68|3.26|||Regression, Logistic||||Arm 3 vs. Arm 2|3.26|1.68|<0.01
71941545|NCT04567342|143404303|SUPERIORITY||Risk Ratio (RR)|1.08||||0.535|TWO_SIDED|95.0|0.85|1.36|||Regression, Logistic||||Arm 4 vs. Arm 3|1.36|0.85|0.535
71941546|NCT04567342|143404303|SUPERIORITY||Risk Ratio (RR)|2.52|||<|0.01|TWO_SIDED|95.0|1.82|3.5|||Regression, Logistic||||Arm 4 vs Arm 2|3.50|1.82|<0.01
71941547|NCT04567342|143404303|SUPERIORITY||Risk Ratio (RR)|2.07|||<|0.01|TWO_SIDED|95.0|1.53|2.8|||Regression, Logistic||||Arm 4 vs. Arm 1|2.80|1.53|<0.01
71941548|NCT04567342|143404304|SUPERIORITY||Risk Ratio (RR)|1.17||||0.192|TWO_SIDED|95.0|0.92|1.48|||Regression, Logistic||||Arm 3 vs. Arm 1|1.48|0.92|0.192
71941549|NCT04567342|143404304|SUPERIORITY||Risk Ratio (RR)|0.81||||0.132|TWO_SIDED|95.0|0.62|1.06|||Regression, Logistic||||Arm 2 vs. Arm 1|1.06|0.62|0.132
71941550|NCT04567342|143404304|SUPERIORITY||Risk Ratio (RR)|1.44|||<|0.01|TWO_SIDED|95.0|1.11|1.86|||Regression, Logistic||||Arm 3 vs. Arm 2|1.86|1.11|<0.01
71941551|NCT04567342|143404304|SUPERIORITY||Risk Ratio (RR)|0.92||||0.462|TWO_SIDED|95.0|0.73|1.16|||Regression, Logistic||||Arm 4 vs. Arm 3|1.16|0.73|0.462
71941552|NCT04567342|143404304|SUPERIORITY||Risk Ratio (RR)|1.32||||0.039|TWO_SIDED|95.0|1.01|1.72|||Regression, Logistic||||Arm 4 vs. Arm 2|1.72|1.01|0.039
71941553|NCT04567342|143404304|SUPERIORITY||Risk Ratio (RR)|1.07||||0.57|TWO_SIDED|95.0|0.84|1.37|||Regression, Logistic||||Arm 4 vs. Arm 1|1.37|0.84|0.570
71941554|NCT01226797|143404305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.5834||||0.6668|TWO_SIDED|95.0|0.1|3.51|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect|||3.51|0.10|0.6668
71941555|NCT01226797|143404306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.1591||||0.155|TWO_SIDED|95.0|0.01|1.73|||Fisher Exact||Odds-ratio and confidence interval obtained from logistic regression with treatment as fixed effect.|||1.73|0.01|0.1550
71941556|NCT01226797|143404307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|25.45||||0.1259|TWO_SIDED|95.0|-7.79|58.69||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||58.69|-7.79|0.1259
71941557|NCT01226797|143404307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.49||||0.3297|TWO_SIDED|95.0|-14.67|41.66||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||41.66|-14.67|0.3297
71941558|NCT01226797|143404307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|15.17||||0.3925|TWO_SIDED|95.0|-21.04|51.39||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||51.39|-21.04|0.3925
71941559|NCT01226797|143404307|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|24.62||||0.208|TWO_SIDED|95.0|-14.85|64.09||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||64.09|-14.85|0.2080
71941560|NCT01226797|143404309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.87||||0.0577|TWO_SIDED|95.0|-0.78|44.53||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 1||44.53|-0.78|0.0577
71941561|NCT01226797|143404309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.3||||0.3669|TWO_SIDED|95.0|-11.71|30.3||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||30.30|-11.71|0.3669
71941562|NCT01226797|143404309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.09||||0.2482|TWO_SIDED|95.0|-10.62|38.8||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 3||38.80|-10.62|0.2482
71941563|NCT01226797|143404309|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|29.19||||0.0801|TWO_SIDED|95.0|-3.84|62.22||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||62.22|-3.84|0.0801
71941564|NCT01226797|143404317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-22.06||||0.0031|TWO_SIDED|95.0|-35.67|-8.44||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 2||-8.44|-35.67|0.0031
71941565|NCT01226797|143404317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-16.34||||0.0015|TWO_SIDED|95.0|-25.64|-7.04||Treatment as fixed effect and baseline as covariate.|ANCOVA|||At Week 4||-7.04|-25.64|0.0015
71941566|NCT01988922|143404324|OTHER|Differences between CYP2B6\*1/\*1, CYP2B6\*1/\*6, and CYP2B6\*6/\*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.|||||<|0.05|||||||ANOVA|One-way ANOVA followed by the Student-Newman-Keuls test for multiple comparisons||||||<0.05
71941567|NCT04977336|143404325|SUPERIORITY|||||||0.3706|||||||ANCOVA|||||||0.3706
71941568|NCT04977336|143404325|SUPERIORITY|||||||0.5379|||||||ANCOVA|||||||0.5379
71941569|NCT04977336|143404325|SUPERIORITY|||||||0.3859|||||||ANCOVA|||||||0.3859
71941570|NCT04977336|143404325|SUPERIORITY|||||||0.0251|||||||ANCOVA|||||||0.0251
71941571|NCT04977336|143404326|SUPERIORITY|||||||0.2318|||||||ANCOVA|||||||0.2318
71941572|NCT04977336|143404326|SUPERIORITY|||||||0.7615|||||||ANCOVA|||||||0.7615
71941573|NCT04977336|143404326|SUPERIORITY|||||||0.387|||||||ANCOVA|||||||0.3870
71941574|NCT04977336|143404326|SUPERIORITY|||||||0.0823|||||||ANCOVA|||||||0.0823
71941575|NCT04977336|143404327|SUPERIORITY|||||||0.9986|||||||Cochran-Mantel-Haenszel|||||||0.9986
71941576|NCT04977336|143404327|SUPERIORITY|||||||0.4446|||||||Cochran-Mantel-Haenszel|||||||0.4446
71941577|NCT04977336|143404327|SUPERIORITY|||||||0.5978|||||||Cochran-Mantel-Haenszel|||||||0.5978
71941578|NCT04977336|143404327|SUPERIORITY|||||||0.0479|||||||Cochran-Mantel-Haenszel|||||||0.0479
71941579|NCT04977336|143404328|SUPERIORITY|||||||0.9895|||||||Cochran-Mantel-Haenszel|||||||0.9895
71941580|NCT04977336|143404328|SUPERIORITY|||||||0.2731|||||||Cochran-Mantel-Haenszel|||||||0.2731
71941581|NCT04977336|143404328|SUPERIORITY|||||||0.6492|||||||Cochran-Mantel-Haenszel|||||||0.6492
71941582|NCT04977336|143404328|SUPERIORITY|||||||0.5119|||||||Cochran-Mantel-Haenszel|||||||0.5119
71941583|NCT04977336|143404329|SUPERIORITY|||||||0.3158|||||||Cochran-Mantel-Haenszel|||||||0.3158
71941584|NCT04977336|143404329|SUPERIORITY|||||||0.3247|||||||Cochran-Mantel-Haenszel|||||||0.3247
71941585|NCT04977336|143404329|SUPERIORITY|||||||0.8424|||||||Cochran-Mantel-Haenszel|||||||0.8424
71941586|NCT04977336|143404329|SUPERIORITY|||||||0.2312|||||||Cochran-Mantel-Haenszel|||||||0.2312
71941587|NCT01347710|143404334|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
71941588|NCT01347710|143404335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress|McNemar|Two-sided McNemar's (chi-squared) test superiority||||||<0.001
71941589|NCT01347710|143404335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
71941590|NCT01347710|143404335|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI \>/=30|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority||||||<0.001
71941591|NCT01347710|143404336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.891|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress|Z test|z test for non inferiority for specificity||||||0.891
71941592|NCT01347710|143404336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.546|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients|z test|z test for non-inferiority for specificity||||||.546
71941593|NCT01347710|143404336|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.538|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI \>/=30|z test|z test for non-inferiority for specificity||||||.538
71941594|NCT01347710|143404337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|McNemar|Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD||||||<0.001
71941595|NCT01347710|143404337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX||||||<0.001
71941596|NCT01347710|143404337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA||||||<0.001
71941597|NCT01347710|143404337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD||||||<0.001
71941598|NCT01347710|143404338|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.379|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|z Test|z test for non-inferiority for specificity; LAD||||||.379
71693753|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.8||||0.0154||95.0|2.9|26.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||26.7|2.9|0.0154
71693754|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.8||||0.7201||95.0|-11.9|8.2|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||8.2|-11.9|0.7201
71693755|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.7||||0.8875||95.0|-9.1|10.5|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.5|-9.1|0.8875
71941599|NCT01347710|143404338|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.358|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|Z Test|z test for non-inferiority for specificity; LCX||||||.358
71941600|NCT01347710|143404338|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.442|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|z Test|z test for non-inferiority for specificity; RCA||||||.442
71941601|NCT01347710|143404338|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.984|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|z Test|z test for non-inferiority for specificity; non-LAD||||||.984
71941602|NCT01347710|143404339|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease|McNemar|p-Value based on two-sided McNemar's (Chi squared) test superiority||||||<0.001
71941603|NCT01347710|143404340|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.827|TWO_SIDED|||||p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease|z test|p-Value based on one-sided z test for non-inferiority||||||0.827
71941604|NCT01347710|143404341|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity||||||<0.001
71941605|NCT01347710|143404342|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.945|ONE_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI|Z Test|one-sided z test for non-inferiority for specificity||||||.945
71941606|NCT01347710|143404343|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.954|TWO_SIDED|||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good|z Test|p-Value based on on-sided z test for non-inferiority for specificity||||||0.954
71941607|NCT01347710|143404344|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||Log Rank|||||||<0.001
71941608|NCT01347710|143404345|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||McNemar|p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT||||||<0.001
71941609|NCT01606306|143404358|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0||||Rank-ordered logistic regression (ROLR) was used to model the probability of best response for each treatment and bootstrapping was used to calculate confidence intervals.|rank-order logistic regression|ROLR is in the class of Discrete Choice models, which seek to estimate the probability that an individual responds best to a specific treatments.||The primary analysis tested the null hypothesis of all three treatments having equal probability to yield the best response as defined by the criteria defining the primary outcome. A sample size of 300 participants was selected to test the primary null hypothesis of all three treatments having equal probability (one-third) to yield the best response with statistical power of at least 0.90 if any one of the three treatments actually has probability of at least one-half to yield the best response.|The probabilistic construct of the Discrete Choice (DC) model does not reflect individual behavior that is intrinsically probabilistic, but rather population heterogeneity. DC models rely on stochastic assumptions to account for unobserved factors related to the treatments themselves and to characteristics of study participants. Specifically, that each treatment has an underlying utility that may differ from one individual to another. Mathematically, these utilities are represented by U\_t, where t denotes the treatment. Utility can be thought of as a latent variable quantifying treatment response where higher values indicate better response. The U\_t can be used to find the probability (P) of best response for each treatment by the following equation: P\_t = exp(U\_t) / \[exp(U\_A) + exp(U\_B) + exp(U\_C)\], where A, B, and C, denote the three study treatments. The primary analysis tested whether the three treatments have equal utility and, thus, equal probability of best response.|||<0.0001
71941610|NCT00970281|143404361|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||The p-value was based on an analysis of variance (ANOVA) model that included treatment and site as a factor.|ANOVA|||Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.||||<0.001
71941611|NCT00970281|143404362|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||This is the p-value for 0.25 hour after first IM injection.|ANOVA|||||||0.009
71941612|NCT00970281|143404362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 0.50 hour after first IM injection.|ANOVA|||||||<0.001
71941613|NCT00970281|143404362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1 hour after first IM injection.|ANOVA|||||||<0.001
71941614|NCT00970281|143404362|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||This is the p-value for the 1.5 hour after first IM injection.|ANOVA|||||||<0.001
71941615|NCT00970281|143404363|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||ANOVA|||||||0.008
71941616|NCT00970281|143404364|SUPERIORITY_OR_OTHER|||||||0.008||95.0|||||Fisher Exact|||||||0.008
71941617|NCT00970281|143404365|SUPERIORITY_OR_OTHER|||||||0.167||95.0||||This is the p-value for the 0.5 hour after the first IM injection.|Fisher Exact|||||||0.167
71941618|NCT00970281|143404365|SUPERIORITY_OR_OTHER|||||||0.134||95.0||||This is the p-value for the 1 hour after the first IM injection.|Fisher Exact|||||||0.134
71941619|NCT00970281|143404365|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 1.5 hour after the first IM injection.|Fisher Exact|||||||0.008
71941620|NCT00970281|143404365|SUPERIORITY_OR_OTHER|||||||0.008||95.0||||This is the p-value for the 2 hours after the first IM injection.|Fisher Exact|||||||0.008
71941621|NCT00970281|143404365|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||This is the p-value for the 24 hours after the first IM injection.|Fisher Exact|||||||0.204
71941622|NCT00970281|143404366|SUPERIORITY_OR_OTHER|||||||1||95.0||||This is the p-value for Parkinsonism.|Fisher Exact|||||||1.000
71941623|NCT02003183|143404370|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_DEVIATION|0.1|<|0.02|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||This analysis applies to the Amygdala.||||<0.02
71941624|NCT02480764|143404425|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-1.932|STANDARD_ERROR_OF_MEAN|1.4512||0.184|TWO_SIDED|95.0|-4.782|0.918||Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||0.918|-4.782|0.184
71941625|NCT02480764|143404425|NON_INFERIORITY|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-3.685|STANDARD_ERROR_OF_MEAN|1.4344||0.01|TWO_SIDED|95.0|-6.502|-0.868||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA|||||-0.868|-6.502|0.010
71941626|NCT02480764|143404426|OTHER||Least Square Mean Difference|-1.459|STANDARD_ERROR_OF_MEAN|0.9455||0.123|TWO_SIDED|95.0|-3.316|0.397||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||0.397|-3.316|0.123
71941627|NCT02480764|143404426|OTHER||Least Square Mean Difference|-2.822|STANDARD_ERROR_OF_MEAN|0.9354||0.003|TWO_SIDED|95.0|-4.659|-0.985||Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA|||||-0.985|-4.659|0.003
71941628|NCT02480764|143404427|OTHER||Odds Ratio (OR)|0.877|STANDARD_ERROR_OF_MEAN|0.192||0.548|TWO_SIDED|95.0|0.571|1.347||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.347|0.571|0.548
71941629|NCT02480764|143404427|OTHER||Odds Ratio (OR)|0.979|STANDARD_ERROR_OF_MEAN|0.2136||0.921|TWO_SIDED|95.0|0.638|1.501||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.501|0.638|0.921
71941630|NCT02480764|143404428|OTHER||Odds Ratio (OR)|1.033|STANDARD_ERROR_OF_MEAN|0.2805||0.904|TWO_SIDED|95.0|0.607|1.759||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.759|0.607|0.904
71941631|NCT02480764|143404428|OTHER||Odds Ratio (OR)|1.074|STANDARD_ERROR_OF_MEAN|0.2897||0.79|TWO_SIDED|95.0|0.633|1.823||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.823|0.633|0.790
71941632|NCT02480764|143404429|OTHER||Odds Ratio (OR)|0.901|STANDARD_ERROR_OF_MEAN|0.1916||0.624|TWO_SIDED|95.0|0.594|1.367||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.367|0.594|0.624
71941633|NCT02480764|143404429|OTHER||Odds Ratio (OR)|1.103|STANDARD_ERROR_OF_MEAN|0.235||0.647|TWO_SIDED|95.0|0.726|1.674||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.674|0.726|0.647
71941634|NCT02480764|143404430|OTHER||Odds Ratio (OR)|0.831|STANDARD_ERROR_OF_MEAN|0.1846||0.404|TWO_SIDED|95.0|0.537|1.284||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.284|0.537|0.404
71941635|NCT02480764|143404430|OTHER||Odds Ratio (OR)|0.937|STANDARD_ERROR_OF_MEAN|0.2078||0.768|TWO_SIDED|95.0|0.606|1.447||Clinic SBP \<140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.447|0.606|0.768
71941636|NCT02480764|143404430|OTHER||Odds Ratio (OR)|1.051|STANDARD_ERROR_OF_MEAN|0.2837||0.852|TWO_SIDED|95.0|0.62|1.784||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.784|0.620|0.852
71941637|NCT02480764|143404430|OTHER||Odds Ratio (OR)|1.045|STANDARD_ERROR_OF_MEAN|0.2788||0.868|TWO_SIDED|95.0|0.62|1.763||Clinic DBP \<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||1.763|0.620|0.868
71941638|NCT02480764|143404430|OTHER||Odds Ratio (OR)|1.042|STANDARD_ERROR_OF_MEAN|0.2244||0.847|TWO_SIDED|95.0|0.684|1.59||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.590|0.684|0.847
71941639|NCT02480764|143404430|OTHER||Odds Ratio (OR)|1.172|STANDARD_ERROR_OF_MEAN|0.2517||0.46|TWO_SIDED|95.0|0.769|1.785||Clinic SBP\<140 mm Hg and DBP\<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||1.785|0.769|0.460
71941640|NCT02480764|143404431|OTHER||Odds Ratio (OR)|1.487|STANDARD_ERROR_OF_MEAN|0.3333||0.077|TWO_SIDED|95.0|0.958|2.307||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.307|0.958|0.077
71941641|NCT02480764|143404431|OTHER||Odds Ratio (OR)|1.914|STANDARD_ERROR_OF_MEAN|0.4229||0.003|TWO_SIDED|95.0|1.241|2.951||Clinic SBP\<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.951|1.241|0.003
71941642|NCT02480764|143404431|OTHER||Odds Ratio (OR)|1.427|STANDARD_ERROR_OF_MEAN|0.3414||0.137|TWO_SIDED|95.0|0.893|2.28||Clinic DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||2.280|0.893|0.137
71941643|NCT02480764|143404431|OTHER||Odds Ratio (OR)|2.017|STANDARD_ERROR_OF_MEAN|0.4816||0.003|TWO_SIDED|95.0|1.263|3.22||Clinic DBP \<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic|||||3.220|1.263|0.003
71941644|NCT02480764|143404431|OTHER||Odds Ratio (OR)|1.424|STANDARD_ERROR_OF_MEAN|0.3407||0.14|TWO_SIDED|95.0|0.891|2.276||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.276|0.891|0.140
71941645|NCT02480764|143404431|OTHER||Odds Ratio (OR)|1.769|STANDARD_ERROR_OF_MEAN|0.4136||0.015|TWO_SIDED|95.0|1.118|2.797||Clinic SBP\<130 mm Hg and DBP\<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic|||||2.797|1.118|0.015
71941646|NCT03629249|143404432|SUPERIORITY|||||||0.714|||||||Wilcoxon (Mann-Whitney)|||||||0.714
71693756|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.7||||0.3735||95.0|-5.7|15.1|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||15.1|-5.7|0.3735
71941647|NCT03629249|143404432|SUPERIORITY|||||||0.734|||||||Wilcoxon (Mann-Whitney)|||||||0.734
71941648|NCT03629249|143404433|SUPERIORITY|||||||0.665|||||||Wilcoxon (Mann-Whitney)|||||||0.665
71941649|NCT03629249|143404433|SUPERIORITY|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||||||0.910
71941650|NCT01030965|143404444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.159|||<|0.001|TWO_SIDED|95.0|0.088|0.229|||Repeated Measures Analysis of Covariance|||||0.229|0.088|<0.001
71941651|NCT01030965|143404444|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.168|||<|0.001|TWO_SIDED|95.0|0.099|0.238|||Repeated Measures Analysis of Covariance|||||0.238|0.099|<0.001
71941652|NCT01030965|143404444|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|||<|0.001|TWO_SIDED|95.0|0.08|0.22|||Repeated Measures Analysis of Covariance|||||0.220|0.080|<0.001
71941653|NCT00743197|143404469|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|0|Other|0.0|STANDARD_DEVIATION|0.0||||||||0||||0||||
71941654|NCT02130466|143404494|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|95.0|0.29|0.74|||||Cox regression model|||0.74|0.29|
71941655|NCT02130466|143404501|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.38|0.95|||||Cox regression model|||0.95|0.38|
71941656|NCT04529109|143404562|SUPERIORITY|The superiority of the Test lens was concluded if the lower limit of the 95% credible interval was above 0.90.|Mean Proportion|0.9998|STANDARD_DEVIATION|0.0005|||TWO_SIDED|95.0|0.999|1.0|||Bayesian Binary model||Interval presented is a 95% Credible interval.|||1.000|0.999|
71941657|NCT05216081|143404576|OTHER||Percentage of enrolled from eligible|69.4|||||TWO_SIDED|95.0|61.5|76.2||||||||76.2|61.5|
71941658|NCT05216081|143404577|OTHER||Percentage of enrolled from eligible|99.0|||||TWO_SIDED|95.0|94.7|99.8||||||||99.8|94.7|
71941659|NCT05216081|143404579|OTHER||Percentage screened positive for EM|15.8|||||TWO_SIDED|95.0|10.0|24.2||||||||24.2|10|
71941660|NCT05216081|143404582|OTHER||Percentage who self-disclosed|57.1|||||TWO_SIDED|95.0|32.6|78.6||||||||78.6|32.6|
71941661|NCT05216081|143404583|OTHER||Percentage substantiated by socialworker|75.0|||||TWO_SIDED|95.0|50.5|89.8||||||||89.8|50.5|
71941662|NCT03100903|143404597|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean ratio (%)|71.64|||||TWO_SIDED|90.0|60.57|84.73|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.7"|||84.73|60.57|
71941663|NCT03100903|143404598|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|29.29|||||TWO_SIDED|90.0|24.27|35.35|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 26.6"|||35.35|24.27|
71941664|NCT03100903|143404599|OTHER|The statistical model was an analysis of variance (ANOVA) model on the logarithmic scale, accounting for the treatment group as a source of variation. The effect 'treatment group' was considered as fixed.|Geometric Mean (gMean) Ratio %|70.22|||||TWO_SIDED|90.0|59.26|83.2|||||"gMean ratio = gMean of BI 655130 high dose SC/gMean of BI 655130 high dose IV.~Inter-individual geometric coefficient of variation (gCV) \[%\] = 23.9"|||83.20|59.26|
71941665|NCT01249664|143404627|SUPERIORITY_OR_OTHER||Difference in least square means|14.1|||<|0.0001|TWO_SIDED|95.0|10.8|17.4||No adjustment on P value, this is for the primary efficacy analysis.|ANCOVA|ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.||17.4|10.8|<0.0001
71941666|NCT01249664|143404628|SUPERIORITY_OR_OTHER||CMH adjusted difference|29.2||||0.0001|TWO_SIDED|95.0|14.4|44.0||No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.|Cochran-Mantel-Haenszel||A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.|Null hypothesis of difference of Eylea minus Sham of 0 was tested.||44.0|14.4|0.0001
71941667|NCT01249664|143404629|SUPERIORITY_OR_OTHER||Difference in least square means|13.1|||<|0.0001|TWO_SIDED|95.0|9.4|16.7|||ANCOVA|||||16.7|9.4|<0.0001
71941668|NCT01249664|143404630|SUPERIORITY_OR_OTHER||CMH adjusted difference|50.5|||<|0.001|TWO_SIDED|95.0|35.0|66.0|||Cochran-Mantel-Haenszel|||||66.0|35.0|<0.001
71941669|NCT01249664|143404631|SUPERIORITY_OR_OTHER||CMH adjusted difference|64.0|||<|0.001|TWO_SIDED|95.0|47.8|80.3|||Cochran-Mantel-Haenszel|||||80.3|47.8|<0.001
71941670|NCT01249664|143404632|SUPERIORITY_OR_OTHER||CMH adjusted difference|21.0||||0.0308|TWO_SIDED|95.0|1.9|40.1|||Cochran-Mantel-Haenszel|||||40.1|1.9|0.0308
71941671|NCT01249664|143404633|SUPERIORITY_OR_OTHER||CMH adjusted difference|27.0||||0.0075|TWO_SIDED|95.0|7.2|46.8|||Cochran-Mantel-Haenszel|||||46.8|7.2|0.0075
71941672|NCT01249664|143404634|SUPERIORITY_OR_OTHER||CMH adjusted difference|42.7|||<|0.0001|TWO_SIDED|95.0|23.7|61.6|||Cochran-Mantel-Haenszel|||||61.6|23.7|<.0001
71941673|NCT01249664|143404635|SUPERIORITY_OR_OTHER||CMH adjusted difference|-6.5||||0.1478|TWO_SIDED|95.0|-15.2|2.3|||Cochran-Mantel-Haenszel|||||2.3|-15.2|0.1478
71941674|NCT01249664|143404636|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.8||||0.0006|TWO_SIDED|95.0|-40.6|-11.0|||Cochran-Mantel-Haenszel|||||-11.0|-40.6|0.0006
71941675|NCT01249664|143404637|SUPERIORITY_OR_OTHER||CMH adjusted difference|-32.2|||<|0.0001|TWO_SIDED|95.0|-48.1|-16.3|||Cochran-Mantel-Haenszel|||||-16.3|-48.1|<0.0001
71693757|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.9||||0.8621||95.0|-8.9|10.6|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.6|-8.9|0.8621
71941676|NCT01249664|143404638|SUPERIORITY_OR_OTHER||CMH adjusted difference|-5.3||||0.2446|TWO_SIDED|95.0|-14.4|3.7|||Cochran-Mantel-Haenszel|||||3.7|-14.4|0.2446
71941677|NCT01249664|143404639|SUPERIORITY_OR_OTHER||CMH adjusted difference|-21.5||||0.0035|TWO_SIDED|95.0|-35.9|-7.0|||Cochran-Mantel-Haenszel|||||-7.0|-35.9|0.0035
71941678|NCT01249664|143404640|SUPERIORITY_OR_OTHER||CMH adjusted difference|-25.7||||0.0012|TWO_SIDED|95.0|-41.3|-10.1|||Cochran-Mantel-Haenszel|||||-10.1|-41.3|0.0012
71941679|NCT01249664|143404641|SUPERIORITY_OR_OTHER||Difference in least square means|-77.9|||<|0.0001|TWO_SIDED|95.0|-108.9|-46.9|||ANCOVA|||||-46.9|-108.9|<0.0001
71941680|NCT01249664|143404642|SUPERIORITY_OR_OTHER||Difference in least square means|-29.3||||0.065|TWO_SIDED|95.0|-60.4|1.8|||ANCOVA|||||1.8|-60.4|0.0650
71941681|NCT01249664|143404643|SUPERIORITY_OR_OTHER||Difference in least square means|-0.4808|||<|0.0001|TWO_SIDED|95.0|-0.599|-0.3626|||ANCOVA|||||-0.3626|-0.5990|<0.0001
71941682|NCT01249664|143404644|SUPERIORITY_OR_OTHER||Difference in least square means|-0.1346||||0.0256|TWO_SIDED|95.0|-0.2525|-0.0167|||ANCOVA|||||-0.0167|-0.2525|0.0256
71941683|NCT01249664|143404645|SUPERIORITY_OR_OTHER||Difference in least square means|-0.0045||||0.869|TWO_SIDED|95.0|-0.0579|0.049|||ANCOVA|||||0.0490|-0.0579|0.8690
71941684|NCT01249664|143404646|SUPERIORITY_OR_OTHER||Difference of least square means|5.21||||0.0104|TWO_SIDED|95.0|1.25|9.18|||ANCOVA|||||9.18|1.25|0.0104
71941685|NCT01249664|143404648|SUPERIORITY_OR_OTHER||Difference in least square means|-0.6648|||<|0.0001|TWO_SIDED|95.0|-0.8056|-0.5239|||ANCOVA|||||-0.5239|-0.8056|<0.0001
71941686|NCT01239121|143404656|SUPERIORITY_OR_OTHER||Slope|0.6||||0.175|TWO_SIDED|95.0|-0.27|1.5|||Regression, Linear|||||1.5|-0.27|0.175
71941687|NCT01239121|143404657|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.964|TWO_SIDED|95.0|0.49|2.1|||Regression, Logistic|||||2.1|.49|0.964
71941688|NCT01050647|143404773|SUPERIORITY|||||||0.31|||||||Chi-squared|||||||0.31
71941689|NCT01050647|143404774|SUPERIORITY||||||>|0.99|||||||Chi-squared|||||||>0.99
71941690|NCT01050647|143404775|SUPERIORITY|||||||0.59|||||||Chi-squared|||||||0.59
71941691|NCT01050647|143404776|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71941692|NCT01050647|143404777|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71941693|NCT04638153|143404782|OTHER||least square mean difference|0.2|||||TWO_SIDED|95.0|-0.2|0.6|||||Month 3|Results based on Mixed-Effect Repeated Measures (MMRM) analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-0.2|
71941694|NCT04638153|143404782|OTHER||Least square mean difference|0.5|||||TWO_SIDED|95.0|0.1|0.9|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.9|0.1|
71941695|NCT04638153|143404782|OTHER||Least square mean difference|-0.3|||||TWO_SIDED|95.0|-0.7|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.7|
71941696|NCT04638153|143404782|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
71941697|NCT04638153|143404782|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
71941698|NCT04638153|143404782|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.2|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.4|
71941699|NCT04638153|143404782|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71941700|NCT04638153|143404782|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71941701|NCT04638153|143404782|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71941702|NCT04638153|143404782|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.2|0.2|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-0.2|
71941703|NCT04638153|143404782|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-0.2|0.3|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.3|-0.2|
71941704|NCT04638153|143404782|OTHER||Least square mean difference|-0.1|||||TWO_SIDED|95.0|-0.4|0.1|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-0.4|
71941705|NCT04638153|143404792|OTHER||Least square mean difference|0.3|||||TWO_SIDED|95.0|-0.5|1.2|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.2|-0.5|
71941706|NCT04638153|143404792|OTHER||Least square mean difference|1.0|||||TWO_SIDED|95.0|0.2|1.8|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.8|0.2|
71941707|NCT04638153|143404792|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.1|||||Month 3|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.1|-1.5|
71941708|NCT04638153|143404792|OTHER||Least square mean difference|-0.5|||||TWO_SIDED|95.0|-1.6|0.6|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.6|-1.6|
71941709|NCT04638153|143404792|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-0.4|1.9|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.9|-0.4|
71941710|NCT04638153|143404792|OTHER||Least square mean difference|-1.2|||||TWO_SIDED|95.0|-2.3|-0.1|||||Month 6|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||-0.1|-2.3|
71941711|NCT04638153|143404792|OTHER||Least square mean difference|0.0|||||TWO_SIDED|95.0|-0.8|0.7|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.7|-0.8|
71941712|NCT04638153|143404792|OTHER||Least square mean difference|0.6|||||TWO_SIDED|95.0|-0.2|1.5|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-0.2|
71941713|NCT04638153|143404792|OTHER||Least square mean difference|-0.7|||||TWO_SIDED|95.0|-1.5|0.2|||||Month 9|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||0.2|-1.5|
71941714|NCT04638153|143404792|OTHER||Least square mean difference|0.1|||||TWO_SIDED|95.0|-1.3|1.5|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.5|-1.3|
71941715|NCT04638153|143404792|OTHER||Least square mean difference|0.7|||||TWO_SIDED|95.0|-1.4|2.8|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||2.8|-1.4|
71941716|NCT04638153|143404792|OTHER||Least square mean difference|-0.6|||||TWO_SIDED|95.0|-2.6|1.4|||||Month 12|Results based on MMRM analysis with gender as a covariate, participant (and/or time) as a random effect; treatment, visit, treatment-by-visit interaction, age and gender as fixed effects using an unstructured covariance matrix.||1.4|-2.6|
71941717|NCT04006171|143404804|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||||||0.004
71941718|NCT04006171|143404805|OTHER|||||||0.004|||||||Roc curve|||||||0.004
71941719|NCT04006171|143404806|OTHER|||||||0.171||||||p value for FSH|Wilcoxon (Mann-Whitney)|for FSH||||||0.171
71941720|NCT04006171|143404806|OTHER|||||||0.176||||||p value for LH|Wilcoxon (Mann-Whitney)|for LH||||||0.176
71941721|NCT04006171|143404807|OTHER|||||||0.306|||||||Wilcoxon (Mann-Whitney)|||||||0.306
71941722|NCT04006171|143404808|OTHER|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||||||0.795
71941723|NCT04006171|143404809|OTHER|||||||0.852|||||||t-test, 2 sided|||||||0.852
71941724|NCT04006171|143404810|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71941725|NCT04006171|143404811|OTHER|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||||||0.277
71941726|NCT04006171|143404812|OTHER|||||||0.006|||||||t-test, 2 sided|||||||0.006
71941727|NCT04006171|143404813|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71941728|NCT04006171|143404814|OTHER|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||||||0.014
71941729|NCT04006171|143404815|OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71941730|NCT04006171|143404816|OTHER|||||||0.947||||||for serum glucose|Wilcoxon (Mann-Whitney)|for serum glucose||||||0.947
71941731|NCT04006171|143404816|OTHER|||||||0.906||||||for total cholesterol|Wilcoxon (Mann-Whitney)|for total cholesterol||||||0.906
71941732|NCT04006171|143404816|OTHER|||||||0.428||||||for triglycerides|Wilcoxon (Mann-Whitney)|for triglycerides||||||0.428
71941733|NCT04006171|143404817|OTHER|||||||0.114||||||for high density lipoprotein|t-test, 2 sided|||||||0.114
71941734|NCT04006171|143404817|OTHER|||||||0.504||||||for low density lipoprotein|Wilcoxon (Mann-Whitney)|for low density lipoprotein||||||0.504
71941735|NCT04006171|143404818|OTHER|||||||0.713|||||||Wilcoxon (Mann-Whitney)|||||||0.713
71941736|NCT04006171|143404819|OTHER|||||||0.886|||||||Wilcoxon (Mann-Whitney)|||||||0.886
71941737|NCT01973348|143404820|NON_INFERIORITY_OR_EQUIVALENCE|A sample size of 12 subjects per group has been shown to be effective for estimating within-group means and variances when little prior data is available.(Julius, 2005) Based on collected data from 34 subjects and effective size difference of 0.1, we reestimate this study as a noninferiority trial with continuous outcome and power calculated as approximately 80%.||||||0.88|||||||t-test, 1 sided|||||||0.88
71941738|NCT02724800|143404832|NON_INFERIORITY|non-inferiority margin = 3.43|Mean Difference (Net)|2.2|||<|0.05|TWO_SIDED|95.0|-0.9|5.6||a priori|Mixed Models Analysis|||||5.6|-0.9|<0.05
71941739|NCT02724800|143404839|SUPERIORITY||Mean Difference (Final Values)|2.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71941740|NCT02724800|143404842|SUPERIORITY||Mean Difference (Final Values)|0.3|||<|0.05|TWO_SIDED||||||Mixed Models Analysis|||||||<0.05
71941741|NCT02458469|143404861|SUPERIORITY|||||||0.019|||||||ANOVA|||||||0.019
71941742|NCT02458469|143404861|SUPERIORITY|||||||0.015|||||||Student-Newman-Keuls Method|||||||0.015
71941743|NCT02458469|143404861|SUPERIORITY|||||||0.231|||||||Student-Newman-Keuls Method|||||||0.231
71941744|NCT02458469|143404862|SUPERIORITY|||||||0.749|||||||ANOVA|||||||0.749
71941745|NCT03561883|143404890|SUPERIORITY||Least squares (LS) mean difference|-0.062||||0.5566|TWO_SIDED|95.0|-0.27|0.146|||MMRM||Treatment difference (IW-3718 - placebo)|Treatment difference calculated as least squares mean (LSM) change from baseline at Week 8; IW-3718 - placebo based on an mixed models repeated measures (MMRM) model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.146|-0.270|0.5566
71941746|NCT03561883|143404891|SUPERIORITY||LS mean difference|-0.008||||0.9226|TWO_SIDED|95.0|-0.176|0.159|||MMRM|||Treatment difference calculated as LSM change from baseline at Week 8; IW-3718 - placebo based on an MMRM model with week (categorical), treatment group, week-by-treatment group and week-by-baseline value interactions, baseline esophagitis status (present vs. not present), and baseline WHSS (\< 3 vs. ≥ 3) as fixed effect terms and baseline value as a covariate, with subject as a random effect. An unstructured covariance structure was used.||0.159|-0.176|0.9226
71941747|NCT03561883|143404892|SUPERIORITY||Difference in Responder Rate|1.3|||||TWO_SIDED|95.0|-6.9|9.5|||||95% confidence interval (CI) for Difference in Responder Rates is obtained using the Newcombe CI.|||9.5|-6.9|
71693758|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.9||||0.1203||95.0|-2.1|17.8|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||17.8|-2.1|0.1203
71941748|NCT03561883|143404892|SUPERIORITY||Odds Ratio (OR)|1.06||||0.7424|TWO_SIDED|95.0|0.76|1.48|||Cochran-Mantel-Haenszel||Odds Ratio for Response (IW-3718 : placebo)|Treatment difference was calculated as the difference in the responder rates at Week 8; IW-3718 - placebo. The 95% CI for the difference in the responder rates was obtained using the Newcombe CI. P value was based on the odds ratio for the response rate (IW-3718:placebo) obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline esophagitis status and baseline heartburn severity level (\< 3 vs. ≥ 3).||1.48|0.76|0.7424
71941749|NCT03561883|143404893|SUPERIORITY||Difference in Proportion Ratio|1.171||||0.4164|TWO_SIDED|95.0|0.8|1.714||Negative binomial model was used to deal with data overdispersion.|Negative binomial model||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||1.714|0.800|0.4164
71941750|NCT03561883|143404893|OTHER|Negative binomial model was used to deal with data overdispersion|Difference in Proportion Ratio|0.034|||||TWO_SIDED|95.0|-0.054|0.123|||||Difference in Proportion Ratio, (1500 mg IW-3718 BID + PPI) - (Placebo + PPI)|Poisson regression including the fixed categorical effect of treatment, the baseline esophagitis status (present vs. not present) and baseline WHSS (\<3 vs. ≥3), the covariate of baseline proportion of heartburn-free days, and with the diary entry duration (in days) as a weight variable adjusted in the model was applied.||0.123|-0.054|
71941751|NCT06354270|143404894|SUPERIORITY||Adjusted Mean Difference|-1.07|STANDARD_ERROR_OF_MEAN|0.111|<|0.0001|TWO_SIDED|95.0|-1.29|-0.85|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.85|-1.29|<0.0001
71941752|NCT06354270|143404895|SUPERIORITY||Adjusted Mean Difference|36.72|STANDARD_ERROR_OF_MEAN|3.319|<|0.0001|TWO_SIDED|95.0|30.14|43.29|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||43.29|30.14|<0.0001
71941753|NCT06354270|143404896|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.083|<|0.0001|TWO_SIDED|95.0|-0.79|-0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||-0.46|-0.79|<0.0001
71941754|NCT06354270|143404897|SUPERIORITY||Adjusted Mean Difference|14.31|STANDARD_ERROR_OF_MEAN|2.128|<|0.0001|TWO_SIDED|95.0|10.09|18.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|||18.52|10.09|<0.0001
71941755|NCT06354270|143404898|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.252||0.196|TWO_SIDED|95.0|-0.83|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 28||0.17|-0.83|0.1960
71693759|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.8||||0.4966||95.0|-5.4|11.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||11.0|-5.4|0.4966
71941756|NCT06354270|143404898|SUPERIORITY||Adjusted Mean Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.344||0.2287|TWO_SIDED|95.0|-1.08|0.28|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q7 (How intense are the sensations?): Change from Baseline at Day 56||0.28|-1.08|0.2287
71941757|NCT06354270|143404898|SUPERIORITY||Adjusted Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.28||0.235|TWO_SIDED|95.0|-0.89|0.22|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 28||0.22|-0.89|0.2350
71941758|NCT06354270|143404898|SUPERIORITY||Adjusted Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|0.328||0.1818|TWO_SIDED|95.0|-1.09|0.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q8 (How bothered are you by any sensations?): Change from Baseline at Day 56||0.21|-1.09|0.1818
71941759|NCT06354270|143404898|SUPERIORITY||Adjusted Mean Difference|-0.54|STANDARD_ERROR_OF_MEAN|0.357||0.1316|TWO_SIDED|95.0|-1.25|0.17|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 28||0.17|-1.25|0.1316
71941760|NCT06354270|143404898|SUPERIORITY||Adjusted Mean Difference|-0.77|STANDARD_ERROR_OF_MEAN|0.417||0.0658|TWO_SIDED|95.0|-1.6|0.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Q9 (How well can you tolerate sensations?): Change from Baseline at Day 56||0.05|-1.60|0.0658
71941761|NCT06354270|143404899|SUPERIORITY||Adjusted Mean Difference|1.19|STANDARD_ERROR_OF_MEAN|4.862||0.8072|TWO_SIDED|95.0|-8.45|10.83|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||10.83|-8.45|0.8072
71941762|NCT06354270|143404899|SUPERIORITY||Adjusted Mean Difference|0.28|STANDARD_ERROR_OF_MEAN|6.175||0.9641|TWO_SIDED|95.0|-11.96|12.52|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||12.52|-11.96|0.9641
71941763|NCT06354270|143404900|SUPERIORITY||Adjusted Mean Difference|0.86|STANDARD_ERROR_OF_MEAN|0.75||0.2538|TWO_SIDED|95.0|-0.63|2.35|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.35|-0.63|0.2538
71941764|NCT06354270|143404900|SUPERIORITY||Adjusted Mean Difference|-0.32|STANDARD_ERROR_OF_MEAN|0.922||0.7311|TWO_SIDED|95.0|-2.15|1.51|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.51|-2.15|0.7311
71941765|NCT06354270|143404901|SUPERIORITY||Adjusted Mean Difference|0.78|STANDARD_ERROR_OF_MEAN|2.162||0.7202|TWO_SIDED|95.0|-3.51|5.06|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||5.06|-3.51|0.7202
71941766|NCT06354270|143404901|SUPERIORITY||Adjusted Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|2.532||0.9859|TWO_SIDED|95.0|-5.06|4.98|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||4.98|-5.06|0.9859
71941767|NCT06354270|143404902|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.78||0.5586|TWO_SIDED|95.0|-2.0|1.09|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||1.09|-2.00|0.5586
71941768|NCT06354270|143404902|SUPERIORITY||Adjusted Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.961||0.873|TWO_SIDED|95.0|-2.06|1.75|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||1.75|-2.06|0.8730
71941769|NCT06354270|143404903|SUPERIORITY||Adjusted Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|1.383||0.6191|TWO_SIDED|95.0|-3.43|2.05|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.05|-3.43|0.6191
71941770|NCT06354270|143404903|SUPERIORITY||Adjusted Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|1.669||0.9521|TWO_SIDED|95.0|-3.41|3.21|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||3.21|-3.41|0.9521
71693760|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|2.2||||0.5776||95.0|-5.6|10.1|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||10.1|-5.6|0.5776
71941771|NCT06354270|143404904|SUPERIORITY||Adjusted Mean Difference|0.69|STANDARD_ERROR_OF_MEAN|0.795||0.3887|TWO_SIDED|95.0|-0.89|2.26|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||2.26|-0.89|0.3887
71941772|NCT06354270|143404904|SUPERIORITY||Adjusted Mean Difference|0.88|STANDARD_ERROR_OF_MEAN|0.989||0.373|TWO_SIDED|95.0|-1.08|2.84|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||2.84|-1.08|0.3730
71941773|NCT06354270|143404905|SUPERIORITY||Adjusted Mean Difference|0.19|STANDARD_ERROR_OF_MEAN|0.134||0.1591|TWO_SIDED|95.0|-0.08|0.46|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.46|-0.08|0.1591
71941774|NCT06354270|143404905|SUPERIORITY||Adjusted Mean Difference|0.14|STANDARD_ERROR_OF_MEAN|0.144||0.3429|TWO_SIDED|95.0|-0.15|0.42|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.42|-0.15|0.3429
71941775|NCT06354270|143404906|SUPERIORITY||Adjusted Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.411||0.136|TWO_SIDED|95.0|-1.43|0.2|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 28||0.20|-1.43|0.1360
71941776|NCT06354270|143404906|SUPERIORITY||Adjusted Mean Difference|-0.46|STANDARD_ERROR_OF_MEAN|0.431||0.2914|TWO_SIDED|95.0|-1.31|0.4|||Mixed Model with Repeated Measures||Adjusted mean difference was calculated as Test toothpaste minus Reference toothpaste.|Change from Baseline at Day 56||0.40|-1.31|0.2914
71941777|NCT01939197|143404907|NON_INFERIORITY|The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).|||||||||||||||||"The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).~Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61."|||
71941778|NCT01939197|143404908|OTHER|||||||1|||||||Fisher Exact|||||||1.000
71941779|NCT01939197|143404909|OTHER||||||||||||||||||"The Fisher exact test was performed as prespecified on the SAP but the p-value couldn't be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as not available."|||
71941780|NCT01968382|143404964|SUPERIORITY|||||||0.3198|||||||ANOVA|||||||0.3198
71941781|NCT01968382|143404967|SUPERIORITY|||||||0.8462|||||||ANOVA|||||||0.8462
71941782|NCT00113425|143404976|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED|95.0|||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
71941783|NCT00113425|143404977|SUPERIORITY_OR_OTHER|||||||0.43|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.43
71941784|NCT00113425|143404978|SUPERIORITY_OR_OTHER|||||||0.79|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.79
71941785|NCT00113425|143404979|SUPERIORITY_OR_OTHER|||||||0.1|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.10
71941786|NCT00113425|143404980|SUPERIORITY_OR_OTHER|||||||0.73|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.73
71693761|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.7||||0.3955||95.0|-4.9|12.3|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.3|-4.9|0.3955
71941787|NCT00113425|143404981|SUPERIORITY_OR_OTHER|||||||0.02|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.02
71941788|NCT00113425|143404982|SUPERIORITY_OR_OTHER|||||||0.003|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.003
71941789|NCT00113425|143404983|SUPERIORITY_OR_OTHER|||||||0.62|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.62
71941790|NCT00113425|143404984|SUPERIORITY_OR_OTHER|||||||0.85|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.85
71941791|NCT00113425|143404985|SUPERIORITY_OR_OTHER|||||||0.49|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.49
71941792|NCT00113425|143404986|SUPERIORITY_OR_OTHER|||||||0.21|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.21
71941793|NCT00113425|143404987|SUPERIORITY_OR_OTHER|||||||0.27|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.27
71941794|NCT00113425|143404988|SUPERIORITY_OR_OTHER|||||||0.04|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.04
71941795|NCT00113425|143404989|SUPERIORITY_OR_OTHER|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients||||0.01
71941796|NCT00406848|143405062|SUPERIORITY_OR_OTHER|||||||0.397||95.0||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.||||0.397
71941797|NCT00406848|143405063|SUPERIORITY_OR_OTHER|||||||0.115||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.115
71941798|NCT00406848|143405063|SUPERIORITY_OR_OTHER|||||||0.004||95.0||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.004
71941799|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.773||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.773
71941800|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.084||95.0||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.084
71941801|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.059||95.0||||p-value is for Maier subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.059
71941802|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.488||95.0||||p-value is for Bech subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.488
71941803|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.048
71941804|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.529||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.529
71941805|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.027||95.0||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.027
71941806|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.749||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.749
71941807|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.296||95.0||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.296
71941808|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.984||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.984
71941809|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.93||95.0||||p-value is for Sleep subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.930
71941810|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.934||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.934
71941811|NCT00406848|143405064|SUPERIORITY_OR_OTHER|||||||0.123||95.0||||p-value is for Retardation subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.123
71941812|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.034||95.0||||p-value is for Severity of Worst Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.034
71941813|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.1||95.0||||p-value is for Severity of Worst Pain - Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.100
71941814|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for Severity of Least Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.009
71941815|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.126||95.0||||p-value is for Severity of Least Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.126
71941816|NCT00406848|143405065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Severity of Average Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71941817|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Severity of Average Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
71941818|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Severity of Pain Right Now Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.016
71941819|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.058||95.0||||p-value is for Severity of Pain Right Now Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.058
71941820|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.011||95.0||||p-value is for Interference with General Activity Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.011
71941821|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||p-value is for Interference with General Activity Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.060
71941822|NCT00406848|143405065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Mood Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71941823|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Interference with Mood Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
71941824|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Walking Ability Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.019
71941825|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Interference with Walking Ability Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.040
71941826|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Interference with Normal Work Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
71941827|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Interference with Normal Work Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.014
71941828|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
71941829|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.01||95.0||||p-value is for Interference with Relations with Other People Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.010
71941830|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.015||95.0||||p-value is for Interference with Sleep Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.015
71941831|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Interference with Sleep Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.005
71941832|NCT00406848|143405065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71941833|NCT00406848|143405065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71941834|NCT00406848|143405065|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Average Interference Score Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||<0.001
71941835|NCT00406848|143405065|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Average Interference Score Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
71941836|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.005||95.0||||p-value is for Overall Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.005
71693762|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|1.0||||0.7994||95.0|-6.9|9.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||9.0|-6.9|0.7994
71941837|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.204||95.0||||p-value is for Overall Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.204
71941838|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.078||95.0||||p-value is for Headaches Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.078
71941839|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.147||95.0||||p-value is for Headaches Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.147
71941840|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||p-value is for Back Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.007
71941841|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.013||95.0||||p-value is for Back Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.013
71941842|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.124||95.0||||p-value is for Shoulder Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.124
71941843|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.231||95.0||||p-value is for Shoulder Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.231
71941844|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.006||95.0||||p-value is for Interference with Daily Activities Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.006
71941845|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Interference with Daily Activities Week 25 main effect of treatment.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit||||||0.019
71941846|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.002||95.0||||p-value is for Time in Pain While Awake Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.002
71693763|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|5.2||||0.2073||95.0|-2.9|13.2|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||13.2|-2.9|0.2073
71941847|NCT00406848|143405066|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Time in Pain While Awake Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.036
71941848|NCT00406848|143405067|SUPERIORITY_OR_OTHER|||||||0.214||95.0||||p-value is for PGI-I at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||0.214
71941849|NCT00406848|143405067|SUPERIORITY_OR_OTHER|||||||0.063||95.0||||p-value is for PGI-I at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\* Visit||||||.063
71941850|NCT00406848|143405068|SUPERIORITY_OR_OTHER|||||||0.162||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.162
71941851|NCT00406848|143405068|SUPERIORITY_OR_OTHER|||||||0.009||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||.009
71941852|NCT00406848|143405069|SUPERIORITY_OR_OTHER|||||||0.555||95.0||||p-value is for change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.555
71941853|NCT00406848|143405069|SUPERIORITY_OR_OTHER|||||||0.785||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||.785
71941854|NCT00406848|143405070|SUPERIORITY_OR_OTHER|||||||0.255||95.0||||p-value is for change from baseline (Week 1) to Week 13.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.255
71941855|NCT00406848|143405070|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline||||||0.038
71941856|NCT00406848|143405071|SUPERIORITY_OR_OTHER|||||||0.706||95.0||||p-values for Week 13 remission (HAMD17 ≤ 7).|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.706
71693764|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.2||||0.5148||95.0|-6.4|12.8|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.8|-6.4|0.5148
71693765|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|3.0||||0.5255||95.0|-6.3|12.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||12.2|-6.3|0.5255
71693766|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.4||||0.3793||95.0|-5.5|14.4|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.4|-5.5|0.3793
71693767|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|4.8||||0.312||95.0|-4.5|14.1|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||14.1|-4.5|0.3120
71693768|NCT00676403|142901944|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.7||||0.0442||95.0|0.3|19.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.||19.2|0.3|0.0442
71693769|NCT00676403|142901945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4452||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4452
71693770|NCT00676403|142901945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4342||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4342
71693771|NCT00676403|142901945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0942||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.0942
71693772|NCT00676403|142901945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1873||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.1873
71693773|NCT00676403|142901945|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4709||95.0|||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.||||0.4709
71693774|NCT04073303|142901953|SUPERIORITY||Rate-Difference|49.0|||<|0.0001|TWO_SIDED|95.0|40.1|54.1|||Cochran-Mantel-Haenszel|||||54.1|40.1|<0.0001
71693775|NCT04073303|142901954|SUPERIORITY||Rate-Difference|71.2|||<|0.0001|TWO_SIDED|95.0|60.7|76.3|||Cochran-Mantel-Haenszel|||||76.3|60.7|<0.0001
71693776|NCT04073303|142901955|SUPERIORITY||Rate-Difference|56.7|||<|0.0001|TWO_SIDED|95.0|45.6|64.5|||Cochran-Mantel-Haenszel|||||64.5|45.6|<0.0001
71693777|NCT04073303|142901956|SUPERIORITY||Rate-Difference|49.7|||<|0.0001|TWO_SIDED|95.0|40.6|57.4|||Cochran-Mantel-Haenszel|||||57.4|40.6|<0.0001
71693778|NCT04073303|142901957|SUPERIORITY||Rate-Difference|70.5|||<|0.0001|TWO_SIDED|95.0|59.6|77.5|||Cochran-Mantel-Haenszel|||||77.5|59.6|<0.0001
71693779|NCT04073303|142901958|SUPERIORITY||LS Mean of Difference|-5.19|||<|0.0001|TWO_SIDED|95.0|-5.64|-4.75|||ANCOVA|||||-4.75|-5.64|<0.0001
71693780|NCT02554760|142901969|OTHER||success proportion|84.2|||||TWO_SIDED|95.0|60.4|92.3|||Catagorical tabulation|||||92.3|60.4|
71693781|NCT02554760|142901969|OTHER||success proportion|78.9|||||TWO_SIDED|95.0|54.4|93.9||||||||93.9|54.4|
71693782|NCT02689804|142901974|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71693783|NCT02689804|142901975|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71693784|NCT03113968|142901995|NON_INFERIORITY|The Farrington-Manning score test was used to assess the noninferiority of KET.|||||<|0.001|||||||The Farrington-Manning score test|||||||<.001
71693785|NCT03113968|142901996|SUPERIORITY||Mean Difference (Net)|9.3|||||TWO_SIDED||||||||||P-values not reported|||
71693786|NCT04805671|142901997|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
71941857|NCT00406848|143405071|SUPERIORITY_OR_OTHER|||||||0.694||95.0||||p-values for Week 25 Remission HAMD17 ≤ 7|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.694
71941858|NCT00406848|143405071|SUPERIORITY_OR_OTHER|||||||0.864||95.0||||p-values for Week 13 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.864
71941859|NCT00406848|143405071|SUPERIORITY_OR_OTHER|||||||0.817||95.0||||p-values for Week 25 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.817
71941860|NCT00406848|143405072|SUPERIORITY_OR_OTHER|||||||0.664||95.0||||p-value is for probability of response at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.664
71941861|NCT00406848|143405072|SUPERIORITY_OR_OTHER|||||||0.31||95.0||||p-value is for probability of response at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\*Visit.||||||0.310
71941862|NCT00406848|143405074|SUPERIORITY_OR_OTHER|||||||0.036||95.0|||||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment\*Visit.||||||0.036
71941863|NCT00406848|143405075|SUPERIORITY_OR_OTHER|||||||0.637||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.637
71941864|NCT00406848|143405075|SUPERIORITY_OR_OTHER|||||||0.001||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.001
71941865|NCT00406848|143405075|SUPERIORITY_OR_OTHER|||||||0.452||95.0||||p-value is for Systolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.452
71941866|NCT00406848|143405075|SUPERIORITY_OR_OTHER|||||||0.193||95.0||||p-value is for Diastolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.193
71941867|NCT00406848|143405076|SUPERIORITY_OR_OTHER|||||||0.121||95.0||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.121
71941868|NCT00406848|143405076|SUPERIORITY_OR_OTHER|||||||0.038||95.0||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.038
71941869|NCT00406848|143405077|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Weight change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.003
71941870|NCT00406848|143405077|SUPERIORITY_OR_OTHER|||||||0.127||95.0||||p-value is for Weight change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\* Visit + Baseline + Baseline\*Visit.||||||0.127
71941871|NCT00406848|143405078|SUPERIORITY_OR_OTHER|||||||0.135||95.0||||p-value is for Diastolic Blood Pressure.|Fisher Exact|||||||0.135
71941872|NCT00406848|143405078|SUPERIORITY_OR_OTHER|||||||1||95.0||||p-value is for Pulse.|Fisher Exact|||Pulse||||1.00
71941873|NCT00406848|143405078|SUPERIORITY_OR_OTHER|||||||0.107||95.0||||p-value is for Systolic Blood Pressure|Fisher Exact|||||||0.107
71941874|NCT00406848|143405078|SUPERIORITY_OR_OTHER|||||||0.235||95.0||||p-value is for Weight Change (gain)|Fisher Exact|||||||0.235
71941875|NCT00406848|143405078|SUPERIORITY_OR_OTHER|||||||0.813||95.0||||p-value is for Weight Change (loss)|Fisher Exact|||||||0.813
71941876|NCT00406848|143405079|SUPERIORITY_OR_OTHER|||||||0.668||95.0||||p-value is for Sustained Hypertension|Fisher Exact|||||||0.668
71941877|NCT00406848|143405079|SUPERIORITY_OR_OTHER|||||||0.201||95.0||||p-value is for Orthostatic Hypotension|Fisher Exact|||||||0.201
71941878|NCT00406848|143405081|SUPERIORITY_OR_OTHER|||||||0.003||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 13.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.003
71693787|NCT04805671|142902002|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
71941879|NCT00406848|143405081|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Platelet Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||<0.001
71941880|NCT00406848|143405082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 13.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
71941881|NCT00406848|143405082|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||p-value is for Uric Acid change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||<0.001
71941882|NCT00406848|143405083|SUPERIORITY_OR_OTHER|||||||0.014||95.0||||p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.014
71941883|NCT00406848|143405084|SUPERIORITY_OR_OTHER|||||||0.019||95.0||||p-value is for Hemoglobin change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.019
71941884|NCT00406848|143405084|SUPERIORITY_OR_OTHER|||||||0.048||95.0||||p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.048
71941885|NCT00406848|143405085|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||p-value is for Chloride change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator||||||0.040
71941886|NCT00406848|143405085|SUPERIORITY_OR_OTHER|||||||0.036||95.0||||p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator||||||0.036
71941887|NCT00406848|143405086|SUPERIORITY_OR_OTHER|||||||0.019||95.0|||||Fisher Exact|||||||0.019
71941888|NCT00406848|143405087|SUPERIORITY_OR_OTHER|||||||0.815||95.0||||p-value is for QT Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.815
71941889|NCT00406848|143405087|SUPERIORITY_OR_OTHER|||||||0.721||95.0||||p-value is for QTcF Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.721
71941890|NCT00406848|143405087|SUPERIORITY_OR_OTHER|||||||0.376||95.0||||p-value is for QTcB Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.376
71941891|NCT00406848|143405087|SUPERIORITY_OR_OTHER|||||||0.065||95.0||||p-value is for PR Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.065
71941892|NCT00406848|143405087|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for QRS Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.110
71941893|NCT00406848|143405088|SUPERIORITY_OR_OTHER|||||||0.11||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.|Fisher Exact|||||||0.110
71941894|NCT00406848|143405088|SUPERIORITY_OR_OTHER|||||||0.016||95.0||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.|Fisher Exact|||||||0.016
71941895|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.511||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.511
71941896|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.300
71941897|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.922||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.922
71941898|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.19||95.0||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.190
71941899|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.85||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.850
71693788|NCT04805671|142902003|SUPERIORITY||Risk Difference (RD)|-8.7||||0.0047|TWO_SIDED|95.0|-14.71|-2.67|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-2.67|-14.71|0.0047
71693789|NCT04805671|142902004|SUPERIORITY||Risk Difference (RD)|-11.3||||0.0007|TWO_SIDED|95.0|-17.86|-4.81|||Regression, Logistic|||ADG20 vs Placebo|A statistical method described in Ge et al. (2011) was used to compute a population-level estimate for the treatment difference (in terms of difference in proportion) with adjustment for the pre-defined prognostic factors. The variance of the estimated treatment difference or relative risk reduction was estimated using the delta method.|-4.81|-17.86|0.0007
71941900|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.158||95.0||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.158
71941901|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.099||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.099
71941902|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.141||95.0||||p-value is for SDST Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.141
71941903|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.379||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.379
71941904|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.858||95.0||||p-value is for 2DCT Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.858
71941905|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.591||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.591
71693790|NCT04805671|142902005|SUPERIORITY||Hazard Ratio (HR)|1.237||||0.0938|TWO_SIDED|95.0|0.964|1.586|||Regression, Cox|||ADG20 vs. Placebo||1.586|0.964|0.0938
71693791|NCT04805671|142902006|SUPERIORITY||Hazard Ratio (HR)|0.137||||0.0361|TWO_SIDED|95.0|0.016|1.162|||Regression, Cox|||ADG20 vs Placebo||1.162|0.016|0.0361
71941906|NCT00406848|143405089|SUPERIORITY_OR_OTHER|||||||0.242||95.0||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline||||||0.242
71941907|NCT02719522|143405120|SUPERIORITY|The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%|||||<|0.001|||||||Clopper-Pearson|||The primary safety objective was to determine if the 2-sided 95% upper confidence interval of the primary safety endpoint was below the threshold of 15%. Missing safety data for subjects who were lost to FU without any evidence of a major stroke/death were imputed in the analysis using multiple imputation. Subjects who withdrew from the study prior to completion and had experienced a major stroke or death were counted towards the primary safety endpoint as having experienced the event.||||<0.001
71693792|NCT04805671|142902007|SUPERIORITY||Hazard Ratio (HR)|1.255||||0.0781|TWO_SIDED|95.0|0.974|1.617|||Regression, Cox|||ADG20 vs Placebo||1.617|0.974|0.0781
71693793|NCT04805671|142902008|SUPERIORITY||Mean Difference (Final Values)|-0.17||||0.4976|TWO_SIDED|95.0|-0.66|0.32|||ANCOVA|||ADG20 vs. Placebo||0.32|-0.66|0.4976
71693794|NCT04805671|142902009|SUPERIORITY||Hazard Ratio (HR)|1.048||||0.7239|TWO_SIDED|95.0|0.806|1.364|||Regression, Cox|||||1.364|0.806|0.7239
71693795|NCT04805671|142902010|SUPERIORITY||Risk Difference (RD)|-11.1||||0.0364|TWO_SIDED|95.0|-21.42|-0.7|||Regression, Logistic|||||-0.70|-21.42|0.0364
71693796|NCT04805671|142902011|SUPERIORITY||Risk Difference (RD)|8.2||||0.0227|TWO_SIDED|95.0|1.15|15.31||The p-value and risk difference reported was calculated based on the Day 5 timepoint.|Regression, Logistic|||||15.31|1.15|0.0227
71693797|NCT04805671|142902012|SUPERIORITY||Mean Difference (Final Values)|-6.93||||0.1124|TWO_SIDED|95.0|-15.49|1.64|||ANCOVA|||||1.64|-15.49|0.1124
71693798|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|7451.0|||||TWO_SIDED|95.0|5857.0|9045.0|||||The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||9045|5857|
71941908|NCT01054599|143405174|OTHER||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||||||>0.05
71941909|NCT01054599|143405177|OTHER||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||||||>0.05
71941910|NCT04025879|143405186|SUPERIORITY||Cox Proportional Hazard|0.58||||0.00025|TWO_SIDED|95.0|0.43|0.78|||Log Rank||Stratified by randomization stratification factors: PD-L1 Status (\>=1% vs \<1%/not evaluable/indeterminate), disease stage (II vs III), histology (squamous vs non-squamous).|||0.78|0.43|0.00025
71941911|NCT04025879|143405188|SUPERIORITY||DIFFERENCE OF PCR|20.5|||||TWO_SIDED|95.0|14.3|26.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||26.6|14.3|
71941912|NCT04025879|143405188|SUPERIORITY||Odds Ratio (OR)|6.64|||||TWO_SIDED|95.0|3.4|12.97|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||12.97|3.40|
71941913|NCT04025879|143405189|SUPERIORITY||DIFFERENCE OF MPR|23.2|||||TWO_SIDED|95.0|15.8|30.6|||||Strata adjusted difference based on Cochran-Mantel-Haenszel (CMH) method of weighting.|||30.6|15.8|
71941914|NCT04025879|143405189|SUPERIORITY||Odds Ratio (OR)|4.01||||||95.0|2.48|6.49|||||Strata adjusted odds ratio using Mantel-Haenszel method.|||6.49|2.48|
71941915|NCT02848326|143405230|SUPERIORITY||Least squares mean difference|-1.15|STANDARD_ERROR_OF_MEAN|0.4||0.0039|TWO_SIDED|95.0|-1.93|-0.37||Mixed-effects model for repeated measures (MMRM) model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.37|-1.93|0.0039
71941916|NCT02848326|143405230|SUPERIORITY||Least squares mean difference|-0.91|STANDARD_ERROR_OF_MEAN|0.33||0.0056|TWO_SIDED|95.0|-1.55|-0.27||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.27|-1.55|0.0056
71941917|NCT02848326|143405230|SUPERIORITY||Least squares mean difference|-0.7|STANDARD_ERROR_OF_MEAN|0.33||0.0325|TWO_SIDED|95.0|-1.35|-0.06||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.06|-1.35|0.0325
71941918|NCT02848326|143405230|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.42||0.001|TWO_SIDED|95.0|-2.21|-0.56||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.56|-2.21|0.0010
71941919|NCT02848326|143405230|SUPERIORITY||Least squares mean difference|-1.29|STANDARD_ERROR_OF_MEAN|0.41||0.0016|TWO_SIDED|95.0|-2.09|-0.49||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.49|-2.09|0.0016
71941920|NCT02848326|143405231|SUPERIORITY||Least squares mean difference|-1.38|STANDARD_ERROR_OF_MEAN|0.43||0.0014|TWO_SIDED|95.0|-2.23|-0.54||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-2.23|0.0014
71941921|NCT02848326|143405231|SUPERIORITY||Least squares mean difference|-1.24|STANDARD_ERROR_OF_MEAN|0.36||0.0005|TWO_SIDED|95.0|-1.94|-0.55||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.55|-1.94|0.0005
71941922|NCT02848326|143405231|SUPERIORITY||Least squares mean difference|-0.94|STANDARD_ERROR_OF_MEAN|0.36||0.0087|TWO_SIDED|95.0|-1.64|-0.24||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.24|-1.64|0.0087
71941923|NCT02848326|143405231|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.46||0.0044|TWO_SIDED|95.0|-2.2|-0.41||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.41|-2.20|0.0044
71941924|NCT02848326|143405231|SUPERIORITY||Least squares mean difference|-1.39|STANDARD_ERROR_OF_MEAN|0.44||0.0017|TWO_SIDED|95.0|-2.26|-0.53||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.53|-2.26|0.0017
71941925|NCT02848326|143405232|SUPERIORITY||Odds Ratio (OR)|1.5||||0.0617|TWO_SIDED|95.0|0.98|2.31||Generalized linear mixed model (GLMM) for repeated measures with fixed factors(treatment group,visit), covariates(baseline migraine days), interactions(treatment group;baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.31|0.98|0.0617
71941926|NCT02848326|143405232|SUPERIORITY||Odds Ratio (OR)|1.46||||0.0369|TWO_SIDED|95.0|1.02|2.08||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.08|1.02|0.0369
71941927|NCT02848326|143405232|SUPERIORITY||Odds Ratio (OR)|1.42||||0.0512|TWO_SIDED|95.0|1.0|2.03||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.03|1.00|0.0512
71941928|NCT02848326|143405232|SUPERIORITY||Odds Ratio (OR)|1.83||||0.0113|TWO_SIDED|95.0|1.15|2.91||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures|||||2.91|1.15|0.0113
71941929|NCT02848326|143405232|SUPERIORITY||Odds Ratio (OR)|2.03||||0.0019|TWO_SIDED|95.0|1.3|3.18||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measure|||||3.18|1.30|0.0019
71941930|NCT02848326|143405233|SUPERIORITY||Least squares mean difference|-1.3|STANDARD_ERROR_OF_MEAN|0.35||0.0002|TWO_SIDED|95.0|-1.99|-0.6||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.60|-1.99|0.0002
71941931|NCT02848326|143405233|SUPERIORITY||Least squares mean difference|-1.44|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001|TWO_SIDED|95.0|-2.01|-0.87||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.87|-2.01|<0.0001
71941932|NCT02848326|143405233|SUPERIORITY||Least squares mean difference|-1.11|STANDARD_ERROR_OF_MEAN|0.29||0.0001|TWO_SIDED|95.0|-1.68|-0.54||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.54|-1.68|0.0001
71941933|NCT02848326|143405233|SUPERIORITY||Least squares mean difference|-1.35|STANDARD_ERROR_OF_MEAN|0.37||0.0003|TWO_SIDED|95.0|-2.08|-0.62||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.62|-2.08|0.0003
71941934|NCT02848326|143405233|SUPERIORITY||Least squares mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.36||0.0007|TWO_SIDED|95.0|-1.93|-0.52||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM|||||-0.52|-1.93|0.0007
71941935|NCT04526210|143405241|OTHER||Geometric least square (LS) mean ratio|0.98|||||TWO_SIDED|90.0|0.9415|1.0205||||||||1.0205|0.9415|
71941936|NCT04526210|143405242|OTHER||Geometric LS mean ratio|0.978|||||TWO_SIDED|90.0|0.9344|1.0244||||||||1.0244|0.9344|
71941937|NCT04526210|143405243|OTHER||Geometric LS mean ratio|0.981|||||TWO_SIDED|90.0|0.9368|1.0269||||||||1.0269|0.9368|
71941938|NCT02999178|143405252|SUPERIORITY||Adjusted mean difference|106.96|STANDARD_ERROR_OF_MEAN|21.15|<|0.0001|TWO_SIDED|95.0|65.42|148.5||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|"Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.~Random effects: time, intercept."|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||148.50|65.42|<.0001
71941939|NCT02999178|143405253|SUPERIORITY||Adjusted mean difference|128.2|STANDARD_ERROR_OF_MEAN|29.17|<|0.0001|TWO_SIDED|95.0|70.81|185.59||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.|Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).||185.59|70.81|<.0001
71941940|NCT02999178|143405254|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.34|STANDARD_ERROR_OF_MEAN|0.84||0.1115|TWO_SIDED|95.0|-0.31|2.98|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||2.98|-0.31|0.1115
71941941|NCT02999178|143405255|OTHER|No formal hypotheses were tested.|Adjusted mean difference|1.53|STANDARD_ERROR_OF_MEAN|1.12||0.1747|TWO_SIDED|95.0|-0.68|3.74|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||3.74|-0.68|0.1747
71941942|NCT02999178|143405256|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.8||||0.3948|TWO_SIDED|95.0|0.48|1.34|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.34|0.48|0.3948
71941943|NCT02999178|143405257|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.67||||0.1985|TWO_SIDED|95.0|0.36|1.24|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.24|0.36|0.1985
71941944|NCT02999178|143405258|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.94||||0.8544|TWO_SIDED|95.0|0.47|1.86|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.86|0.47|0.8544
71941945|NCT02999178|143405259|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.68||||0.3291|TWO_SIDED|95.0|0.32|1.47|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||1.47|0.32|0.3291
71693799|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|11545.0|||||TWO_SIDED|95.0|8827.0|14263.0|||||The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||14263|8827|
71941946|NCT02999178|143405262|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.65||||0.0017|TWO_SIDED|95.0|0.49|0.85|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.85|0.49|0.0017
71941947|NCT02999178|143405263|OTHER|No formal hypotheses were tested.|Hazard Ratio (HR)|0.64||||0.0081|TWO_SIDED|95.0|0.45|0.89|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.|||0.89|0.45|0.0081
71941948|NCT02999178|143405264|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.7|||||TWO_SIDED|95.0|0.52|0.96|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.96|0.52|
71941949|NCT02999178|143405265|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.63|||||TWO_SIDED|95.0|0.43|0.94|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.94|0.43|
71941950|NCT02999178|143405266|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.5|||||TWO_SIDED|95.0|0.36|0.68|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred and binary covariate HRCT fibrotic pattern.|Ratio calculated as Nintedanib divided by Placebo.|||0.68|0.36|
71941951|NCT02999178|143405267|OTHER|No formal hypotheses were tested.|Adjusted Odds Ratio|0.46|||||TWO_SIDED|95.0|0.31|0.69|||Regression, Logistic|Logistic regression model with continuous covariate baseline FVC % pred.|Ratio calculated as Nintedanib divided by Placebo.|||0.69|0.31|
71941952|NCT02999178|143405268|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-3.53|STANDARD_ERROR_OF_MEAN|1.33|||TWO_SIDED|95.0|-6.14|-0.92|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.92|-6.14|
71941953|NCT02999178|143405269|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-4.18|STANDARD_ERROR_OF_MEAN|1.68|||TWO_SIDED|95.0|-7.48|-0.88|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-0.88|-7.48|
71941954|NCT02999178|143405270|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-6.09|STANDARD_ERROR_OF_MEAN|1.81|||TWO_SIDED|95.0|-9.65|-2.53|||Mixed Model Repeated Measures|Fixed effects: baseline, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.53|-9.65|
71941955|NCT02999178|143405271|OTHER|No formal hypotheses were tested.|Adjusted mean difference|-7.28|STANDARD_ERROR_OF_MEAN|2.33|||TWO_SIDED|95.0|-11.86|-2.71|||Mixed Model Repeated Measures|Fixed effects: baseline, visit, treatment-by-visit interaction, baseline-by-visit interaction, random effect: participant.|Adjusted mean difference was calculated as Nintedanib - Placebo.|||-2.71|-11.86|
71941956|NCT00090857|143405272|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.15
71941957|NCT00090857|143405273|SUPERIORITY_OR_OTHER|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.70
71941958|NCT00090857|143405274|SUPERIORITY_OR_OTHER|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.03
71941959|NCT00090857|143405275|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.||||0.06
71941960|NCT00090857|143405276|SUPERIORITY_OR_OTHER|||||||0.38|||||||Fisher Exact|||||||0.38
71941961|NCT00090857|143405277|SUPERIORITY_OR_OTHER|||||||0.02|||||||Fisher Exact|||||||0.02
71941962|NCT00090857|143405278|SUPERIORITY_OR_OTHER|||||||0.2|||||||Fisher Exact|||||||0.20
71941963|NCT00090857|143405279|SUPERIORITY_OR_OTHER|||||||0.88|||||||Fisher Exact|||||||.88
71941964|NCT00090857|143405280|SUPERIORITY_OR_OTHER|||||||0.27|||||||Fisher Exact|||||||0.27
71941965|NCT00090857|143405281|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||.60
71941966|NCT00090857|143405282|SUPERIORITY_OR_OTHER|||||||0.58|||||||Fisher Exact|||||||.58
71941967|NCT00090857|143405283|SUPERIORITY_OR_OTHER|||||||0.49|||||||Fisher Exact|||||||.49
71941968|NCT05097326|143405284|OTHER|||||||0.44||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of total contractions||||0.44
71941969|NCT05097326|143405284|OTHER|||||||0.02||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Analysis of contractions per hour||||0.02
71941970|NCT05097326|143405285|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison at 12 hours after labor induction||||0.04
71941971|NCT05097326|143405285|OTHER|||||||0.17||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||Comparison of uterine tachysystole of total labor duration||||0.17
71941972|NCT05097326|143405286|OTHER|||||||0.63||||||a p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.63
71941973|NCT05097326|143405287|OTHER|||||||0.01||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.01
71941974|NCT05097326|143405288|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at complete cervical dilation||||0.04
71941975|NCT05097326|143405289|OTHER|||||||0.04||||||a p-value of \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||Comparison at postpartum transfer||||0.04
71941976|NCT05097326|143405290|OTHER|||||||0.68||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.68
71941977|NCT05097326|143405291|OTHER|||||||1||||||A p-value of \<0.05 would be considered significant.|Fisher Exact|||||||1
71941978|NCT05097326|143405292|OTHER|||||||1||||||a p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||1
71941979|NCT05097326|143405293|OTHER|||||||0.9||||||A p-value \<0.05 would be considered statistically significant|Wilcoxon (Mann-Whitney)|||||||0.90
71941980|NCT05097326|143405294|OTHER|||||||0.17||||||a p-value \<0.05 would be considered statistically significant|Fisher Exact|||1 minute APGAR score||||0.17
71941981|NCT05097326|143405294|OTHER|||||||1||||||A p-value of \<0.05 would be statistically significant.|Fisher Exact|||APGAR score at 5 minutes||||1
71941982|NCT05097326|143405295|OTHER|||||||0.22||||||A p-value of \<0.05 would be considered statistically significant|Fisher Exact|||||||0.22
71941983|NCT03480425|143405297|SUPERIORITY||Mean Difference (Final Values)|0.12|STANDARD_DEVIATION|4.4|<|0.05|TWO_SIDED|95.0|-2.4|2.6|||t-test, 2 sided|||||2.6|-2.4|<0.05
71941984|NCT02424188|143405303|SUPERIORITY||Odds Ratio (OR)|5.9|||||TWO_SIDED|95.0|2.3|15.4||||||||15.4|2.3|
71941985|NCT02424188|143405304|SUPERIORITY||Odds Ratio (OR)|3.9|||||TWO_SIDED|95.0|1.2|12.3||||||||12.3|1.2|
71941986|NCT02424188|143405305|SUPERIORITY||Odds Ratio (OR)|4.8|||||TWO_SIDED|95.0|1.3|17.5||||||6 month comparison||17.5|1.3|
71941987|NCT02424188|143405305|SUPERIORITY||Odds Ratio (OR)|10.8|||||TWO_SIDED|95.0|2.4|48.6||||||12 month||48.6|2.4|
71941988|NCT02424188|143405307|SUPERIORITY||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.7|2.3||||||6 months||2.3|-1.7|
71941989|NCT02424188|143405307|SUPERIORITY||Mean Difference (Net)|1.6|||||TWO_SIDED|95.0|-1.5|4.7||||||18 months||4.7|-1.5|
71693800|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|61.0|||||TWO_SIDED|95.0|58.0|63.0|||||The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||63|58|
71693801|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|51.0|||||TWO_SIDED|95.0|49.0|53.0|||||The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||53|49|
71941990|NCT02424188|143405308|SUPERIORITY||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.6|1.5||||||||1.5|-0.6|
71941991|NCT02424188|143405310|SUPERIORITY||Mean Difference (Net)|-16.2|||||TWO_SIDED|95.0|-30.2|-2.3||||||||-2.3|-30.2|
71941992|NCT02086188|143405322|SUPERIORITY|||||||0.1911|||||||ANCOVA|||||||0.1911
71941993|NCT02086188|143405323|SUPERIORITY|||||||0.4271|||||||ANCOVA|||||||0.4271
71941994|NCT02086188|143405324|SUPERIORITY|||||||0.1723|||||||ANCOVA|||||||0.1723
71941995|NCT02086188|143405325|SUPERIORITY|||||||0.634|||||||ANCOVA|||||||0.6340
71941996|NCT02086188|143405326|SUPERIORITY|||||||0.0091|||||||ANCOVA|||||||0.0091
71941997|NCT02753842|143405328|SUPERIORITY||Mean Difference (Final Values)|1.39|||<|0.05|TWO_SIDED|95.0|0.52|2.26||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing fitted to standard condoms, the null hypothesis was no difference in pleasure.||2.26|0.52|<0.05
71941998|NCT02753842|143405329|SUPERIORITY||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.92|1.38|||Mixed Models Analysis|||A single item assessed whether participants preferred fitted condoms or standard condoms at the end of the study (the item word viewed by participants used the blinded identifiers of each condom type).||1.38|0.92|>0.05
71941999|NCT02753842|143405331|SUPERIORITY||Odds Ratio (OR)|0.93|||>|0.05|TWO_SIDED|95.0|0.27|3.24|||logistic mixed effects model|||We assessed clinical condom failure for anal sex, comparing anal sex acts with fitted condoms to anal sex acts with standard condoms.||3.24|0.27|>0.05
71942000|NCT02753842|143405332|SUPERIORITY||Median Difference (Final Values)|1.06|||<|0.05|TWO_SIDED|95.0|0.18|1.94||The a priori threshold was p\<0.05.|Mixed Models Analysis|||Comparing thin to standard condoms, the null hypothesis was no difference in pleasure.||1.94|0.18|<0.05
71942001|NCT03471078|143405333|OTHER|The primary efficacy endpoint was tested between avatrombopag and placebo using the Cochran-Mantel-Haenszel 2-sided test at α=0.05, adjusting for the number of eligible chemotherapy agents as collected in IWRS (1 or ≥2 permissible chemotherapy agents).|Mean Difference (Final Values)|-3.0||||0.7186|TWO_SIDED|95.0|-21.7|15.6|||Cochran-Mantel-Haenszel|||||15.6|-21.7|0.7186
71942002|NCT03471078|143405334|OTHER|||||||0.8372|||||||Van Elteren Test|||||||0.8372
71942003|NCT00153803|143405352|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.165|TWO_SIDED|95.0|0.65|1.33|||Log Rank|||||1.33|0.65|0.165
71942004|NCT00153803|143405353|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.32|TWO_SIDED|95.0|0.85|1.63|||Log Rank|||||1.63|0.85|0.32
71942005|NCT01882647|143405357|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.||||||<0.001
71942006|NCT01882647|143405358|SUPERIORITY_OR_OTHER||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.001
71942007|NCT01882647|143405359|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.01
71942008|NCT01882647|143405360|SUPERIORITY_OR_OTHER||||||<|0.01||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).||||<0.01
71942009|NCT02937701|143405363|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.37|||||TWO_SIDED|90.0|2.67|15.96||||||For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).||15.96|2.67|
71693802|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|231.0|||||TWO_SIDED|95.0|227.0|234.0|||||The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||234|227|
71693803|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|295.0|||||TWO_SIDED|95.0|290.0|299.0|||||The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||299|290|
71693804|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|873.0|||||TWO_SIDED|95.0|827.0|919.0|||||The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||919|827|
71693805|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|1080.0|||||TWO_SIDED|95.0|1022.0|1138.0|||||The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1138|1022|
71693806|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|1267.0|||||TWO_SIDED|95.0|1251.0|1283.0|||||The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1283|1251|
71942010|NCT02937701|143405363|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.3|||||TWO_SIDED|90.0|2.67|15.92|||||Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.|A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.||15.92|2.67|
71942011|NCT02937701|143405363|EQUIVALENCE|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|7.184|||||TWO_SIDED|90.0|0.748|13.62|||||The ACR core set includes tender joint count, swollen joint count, subject's global health assessment, investigator's global health assessment, subject's assessment of disease related pain, HAQ-DI, and CRP.|A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).||13.620|0.748|
71942012|NCT02937701|143405364|OTHER||Response Difference|8.03|||||TWO_SIDED|90.0|1.15|14.81||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||14.81|1.15|
71942013|NCT02937701|143405364|OTHER||Response Difference|4.96|||||TWO_SIDED|90.0|-1.8|11.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.64|-1.80|
71942014|NCT02937701|143405364|OTHER||Response Difference|9.37|||||TWO_SIDED|90.0|-0.51|12.87||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.87|-0.51|
71942015|NCT02937701|143405365|OTHER||Response Difference|3.05|||||TWO_SIDED|90.0|-5.26|11.73||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.73|-5.26|
71942016|NCT02937701|143405365|OTHER||Response Difference|8.5|||||TWO_SIDED|90.0|-1.18|17.97||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.97|-1.18|
71693807|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|1250.0|||||TWO_SIDED|95.0|1234.0|1266.0|||||The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1266|1234|
71693808|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|1175.0|||||TWO_SIDED|95.0|1083.0|1267.0|||||The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1267|1083|
71693809|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|1566.0|||||TWO_SIDED|95.0|1438.0|1695.0|||||The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||1695|1438|
71693810|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|2991.0|||||TWO_SIDED|95.0|2922.0|3059.0|||||The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3059|2922|
71942017|NCT02937701|143405365|OTHER||Response Difference|3.31|||||TWO_SIDED|90.0|-4.61|11.7||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.70|-4.61|
71942018|NCT02937701|143405365|OTHER||Response Difference|4.06|||||TWO_SIDED|90.0|-5.4|13.4||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.40|-5.40|
71942019|NCT02937701|143405365|OTHER||Response Difference|0.82|||||TWO_SIDED|90.0|-7.34|9.4||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.40|-7.34|
71942020|NCT02937701|143405365|OTHER||Response Difference|2.79|||||TWO_SIDED|90.0|-6.86|12.34||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||12.34|-6.86|
71693811|NCT01387178|142902018|SUPERIORITY_OR_OTHER||Adjusted Mean|3304.0|||||TWO_SIDED|95.0|3221.0|3386.0|||||The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.|||3386|3221|
71693812|NCT01387178|142902019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.964||||0.2198||95.0|0.909|1.022||Risk of Moderate COPD Exacerbations|Regression, Cox|||||1.022|0.909|0.2198
71942021|NCT02937701|143405365|OTHER||Response Difference|-3.74|||||TWO_SIDED|90.0|-12.27|5.17||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||5.17|-12.27|
71942022|NCT02937701|143405365|OTHER||Response Difference|1.12|||||TWO_SIDED|90.0|-8.89|11.08||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||11.08|-8.89|
71942023|NCT02937701|143405365|OTHER||Response Difference|-5.25|||||TWO_SIDED|90.0|-13.24|3.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.29|-13.24|
71693813|NCT01387178|142902019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.864||||0.0406||95.0|0.752|0.994||Risk of Severe COPD Exacerbations|Regression, Cox|||||0.994|0.752|0.0406
71942024|NCT02937701|143405365|OTHER||Response Difference|-1.49|||||TWO_SIDED|90.0|-11.01|8.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.04|-11.01|
71942025|NCT02937701|143405366|OTHER||Response Difference|4.41|||||TWO_SIDED|90.0|-0.56|9.38||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.38|-0.56|
71942026|NCT02937701|143405366|OTHER||Response Difference|1.62|||||TWO_SIDED|90.0|-4.71|7.94||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.94|-4.71|
71942027|NCT02937701|143405366|OTHER||Response Difference|2.3|||||TWO_SIDED|90.0|-4.45|9.03||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.03|-4.45|
71942028|NCT02937701|143405366|OTHER||Response Difference|7.09|||||TWO_SIDED|90.0|0.27|13.83||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.83|0.27|
71942029|NCT02937701|143405367|OTHER||Response Difference|-1.33|||||TWO_SIDED|90.0|-10.4|7.62||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.62|-10.40|
71693814|NCT01387178|142902019|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.953||||0.0962||95.0|0.901|1.009||Risk of Any COPD Exacerbation|Regression, Cox|||||1.009|0.901|0.0962
71942030|NCT02937701|143405367|OTHER||Response Difference|3.24|||||TWO_SIDED|90.0|-7.28|13.67||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.67|-7.28|
71942031|NCT02937701|143405367|OTHER||Response Difference|6.52|||||TWO_SIDED|90.0|-2.62|15.48||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||15.48|-2.62|
71942032|NCT02937701|143405367|OTHER||Response Difference|10.74|||||TWO_SIDED|90.0|0.12|21.03||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||21.03|0.12|
71942033|NCT02937701|143405367|OTHER||Response Difference|0.56|||||TWO_SIDED|90.0|-8.54|9.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.59|-8.54|
71942034|NCT02937701|143405367|OTHER||Response Difference|2.93|||||TWO_SIDED|90.0|-7.62|13.39||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.39|-7.62|
71942035|NCT02937701|143405367|OTHER||Response Difference|-1.04|||||TWO_SIDED|90.0|-10.11|7.93||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.93|-10.11|
71942036|NCT02937701|143405367|OTHER||Response Difference|6.14|||||TWO_SIDED|90.0|-4.44|16.54||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||16.54|-4.44|
71942037|NCT02937701|143405367|OTHER||Response Difference|-5.43|||||TWO_SIDED|90.0|-14.39|3.71||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||3.71|-14.39|
71942038|NCT02937701|143405367|OTHER||Response Difference|2.98|||||TWO_SIDED|90.0|-7.51|13.37||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.37|-7.51|
71942039|NCT02937701|143405368|OTHER||Response Difference|-2.5|||||TWO_SIDED|90.0|-5.84|0.83||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||0.83|-5.84|
71942040|NCT02937701|143405368|OTHER||Response Difference|-2.43|||||TWO_SIDED|90.0|-7.47|2.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||2.64|-7.47|
71942041|NCT02937701|143405368|OTHER||Response Difference|5.46|||||TWO_SIDED|90.0|-0.01|10.91||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.91|-0.01|
71942042|NCT02937701|143405368|OTHER||Response Difference|4.58|||||TWO_SIDED|90.0|-1.21|10.34||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.34|-1.21|
71693815|NCT02782741|142902037|NON_INFERIORITY|NI was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference of avalglucosidase alfa minus alglucosidase alfa was greater than (\>) -1.1.|LS mean difference|2.43|STANDARD_ERROR_OF_MEAN|1.29||0.0074|TWO_SIDED|95.0|-0.13|4.99|||mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||4.99|-0.13|0.0074
71693816|NCT02782741|142902037|SUPERIORITY|A test for superiority of avalglucosidase alfa versus alglucosidase alfa was performed with an overall 5% level of significance.||||||0.0626||||||Threshold for significance at \<0.05 level.|mixed model for repeated measures|||Analysis performed using MMRM model with baseline FVC (% predicted, as continuous), sex, age (in years at baseline), treatment group, visit, interaction term between treatment group and visit as fixed effects.||||0.0626
71942043|NCT02937701|143405369|OTHER||Response Difference|0.2|||||TWO_SIDED|90.0|-8.12|8.02||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||8.02|-8.12|
71942044|NCT02937701|143405369|OTHER||Response Difference|-0.08|||||TWO_SIDED|90.0|-9.39|9.28||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.28|-9.39|
71942045|NCT02937701|143405369|OTHER||Response Difference|1.5|||||TWO_SIDED|90.0|-7.0|9.51||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||9.51|-7.00|
71942046|NCT02937701|143405369|OTHER||Response Difference|7.49|||||TWO_SIDED|90.0|-2.39|17.22||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.22|-2.39|
71942047|NCT02937701|143405369|OTHER||Response Difference|-0.5|||||TWO_SIDED|90.0|-9.03|7.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.59|-9.03|
71942048|NCT02937701|143405369|OTHER||Response Difference|3.39|||||TWO_SIDED|90.0|-6.41|13.14||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||13.14|-6.41|
71942049|NCT02937701|143405369|OTHER||Response Difference|-0.43|||||TWO_SIDED|90.0|-8.98|7.66||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||7.66|-8.98|
71942050|NCT02937701|143405369|OTHER||Response Difference|7.87|||||TWO_SIDED|90.0|-2.13|17.68||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||17.68|-2.13|
71942051|NCT02937701|143405369|OTHER||Response Difference|1.95|||||TWO_SIDED|90.0|-6.81|10.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||10.29|-6.81|
71942052|NCT02937701|143405369|OTHER||Response Difference|12.06|||||TWO_SIDED|90.0|1.74|22.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).||22.04|1.74|
71942053|NCT02937701|143405370|OTHER||Mean Difference|-0.07|||||TWO_SIDED|90.0|-0.2|0.007||||||Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.007|-0.20|
71942054|NCT02937701|143405370|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.17|0.16||||||Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.16|-0.17|
71942055|NCT02937701|143405370|OTHER||Mean Difference|-0.04|||||TWO_SIDED|90.0|-0.21|0.14||||||Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.14|-0.21|
71942056|NCT02937701|143405370|OTHER||Mean Difference|-0.01|||||TWO_SIDED|90.0|-0.2|0.17||||||Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.17|-0.20|
71942057|NCT02937701|143405371|OTHER||Mean Difference|0.16|||||TWO_SIDED|90.0|-0.08|0.4||||||Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.40|-0.08|
71942058|NCT02937701|143405371|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.27|0.28||||||Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.28|-0.27|
71942059|NCT02937701|143405371|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.12|0.35||||||Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.35|-0.12|
71942060|NCT02937701|143405371|OTHER||Mean Difference|-0.03|||||TWO_SIDED|90.0|-0.3|0.24||||||Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.30|
71942061|NCT02937701|143405371|OTHER||Mean Difference|0.06|||||TWO_SIDED|90.0|-0.18|0.3||||||Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.30|-0.18|
71693817|NCT02782741|142902038|SUPERIORITY|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|30.01|STANDARD_ERROR_OF_MEAN|14.43||0.0405|TWO_SIDED|95.0|1.33|58.69|||mixed model for repeated measures|||LS mean difference was derived from MMRM model with baseline FVC (% predicted) and baseline 6MWT (distance walked in meter), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||58.69|1.33|0.0405
71693818|NCT02782741|142902039|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|3.13|STANDARD_ERROR_OF_MEAN|5.24||0.5522|TWO_SIDED|95.0|-7.31|13.57|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MIP % predicted adjusted for MIP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||13.57|-7.31|0.5522
71693819|NCT02782741|142902040|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|-1.94|STANDARD_ERROR_OF_MEAN|5.64||0.7321|TWO_SIDED|95.0|-13.17|9.29|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for MEP % predicted adjusted for MEP % predicted at baseline, age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||9.29|-13.17|0.7321
71693820|NCT02782741|142902041|OTHER|Per the protocol-defined statistical test strategy for multiplicity adjustment, and since superiority was narrowly missed for FVC % predicted, superiority testing for the secondary outcome measure couldn't be performed.|LS mean difference|106.97|STANDARD_ERROR_OF_MEAN|67.17||0.115|TWO_SIDED|95.0|-26.56|240.5|||mixed model for repeated measures|||LS mean difference was derived from MMRM model for HHD lower extremity muscle strength composite score adjusted for summary HHD lower extremity score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||240.50|-26.56|0.1150
71693821|NCT02782741|142902042|OTHER|No formal testing of additional secondary endpoint of QMFT.|LS mean difference|2.08|STANDARD_ERROR_OF_MEAN|0.94||0.0288|TWO_SIDED|95.0|0.22|3.95||Nominal p-value.|mixed model for repeated measures|||LS mean difference was derived from MMRM models adjust for total QMFT score at baseline, baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.95|0.22|0.0288
71693822|NCT02782741|142902043|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|0.77|STANDARD_ERROR_OF_MEAN|1.46||0.5996|TWO_SIDED|95.0|-2.13|3.67|||mixed model for repeated measures|||The MMRM models adjust for baseline score (PCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||3.67|-2.13|0.5996
71693823|NCT02782741|142902043|OTHER|No formal testing of additional secondary endpoint of SF-12.|Score difference|2.12|STANDARD_ERROR_OF_MEAN|1.8||0.2427|TWO_SIDED|95.0|-1.46|5.69|||mixed model for repeated measures|||The MMRM models adjust for baseline score (MCS), baseline FVC (% predicted), age (in years, at baseline), gender, treatment group, visit, and treatment-by-visit interaction as fixed effects.||5.69|-1.46|0.2427
71693824|NCT01871077|142902098|OTHER|||||||0.89|||||||Friedman test|||||||0.890
71693825|NCT01871077|142902099|OTHER|||||||0.078|||||||Wilcoxon (Mann-Whitney)|||||||0.078
71693826|NCT01871077|142902100|OTHER|||||||1|||||||Friedman test|||||||1.000
71693827|NCT01871077|142902101|OTHER|||||||0.497|||||||Wilcoxon (Mann-Whitney)|||||||.497
71693828|NCT04878120|142902128|SUPERIORITY|||||||0.733||||||For interaction between study group and intervention|ANOVA|||"The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. To test the hypothesis that HCL Control with Smart Bolus Calculator reduces exposure to hypoglycemia with respect to Standard HCL Control, a mixed ANOVA was performed with LBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor."||||0.733
71693829|NCT04878120|142902129|SUPERIORITY|||||||0.824||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent below 70 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.824
71693830|NCT04878120|142902130|SUPERIORITY|||||||0.402||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent in 70-180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.402
71942062|NCT02937701|143405371|OTHER||Mean Difference|-0.08|||||TWO_SIDED|90.0|-0.36|0.2||||||Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.20|-0.36|
71942063|NCT02937701|143405371|OTHER||Mean Difference|0.11|||||TWO_SIDED|90.0|-0.14|0.37||||||Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.37|-0.14|
71693831|NCT04878120|142902131|SUPERIORITY|||||||0.3||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with percentage of time spent above 180 mg/dL as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.300
71693832|NCT04878120|142902132|SUPERIORITY|||||||0.168||||||For interaction between study arm and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with HBGI as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.168
71693833|NCT04878120|142902133|SUPERIORITY|||||||0.476||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with CGM coefficient of variation as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.476
71693834|NCT04878120|142902134|SUPERIORITY|||||||0.914||||||For interaction between study group and intervention|ANOVA|||The study followed a randomized crossover design, with two study groups and two intervention types; the two groups differed in the order they received the two intervention types. A mixed ANOVA was performed with total amount of carbohydrate administered as rescue treatments as outcome measure, study group as between-subject factor, and intervention type as within-subject factor.||||0.914
71942064|NCT02937701|143405371|OTHER||Mean Difference|-0.05|||||TWO_SIDED|90.0|-0.34|0.25||||||Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.25|-0.34|
71942065|NCT02937701|143405371|OTHER||Mean Difference|0.0|||||TWO_SIDED|90.0|-0.24|0.24||||||Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.24|-0.24|
71942066|NCT02937701|143405371|OTHER||Mean Difference|-0.2|||||TWO_SIDED|90.0|-0.47|0.08||||||Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.||0.08|-0.47|
71942067|NCT03292653|143405376|SUPERIORITY||Difference in Least Squares (LS) Means|1.26|STANDARD_ERROR_OF_MEAN|3.64||0.736|TWO_SIDED|90.0|-5.4|7.93|||ANCOVA|||Analysis of Covariance (ANCOVA) model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||7.93|-5.4|0.736
71942068|NCT03292653|143405376|SUPERIORITY||Difference in LS Means|-1.02|STANDARD_ERROR_OF_MEAN|3.38||0.7694|TWO_SIDED|90.0|-7.22|5.18|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic, ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.18|-7.22|0.7694
71942069|NCT03292653|143405377|SUPERIORITY||Difference in LS Means|-0.04|STANDARD_ERROR_OF_MEAN|0.03||0.184|TWO_SIDED|90.0|-0.09|0.01|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.01|-0.09|0.184
71942070|NCT03292653|143405377|SUPERIORITY||Difference in LS Means|-0.03|STANDARD_ERROR_OF_MEAN|0.03||0.3397|TWO_SIDED|90.0|-0.07|0.02|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||0.02|-0.07|0.3397
71942071|NCT03292653|143405378|SUPERIORITY||Difference in LS Means|-17.07|STANDARD_ERROR_OF_MEAN|9.12||0.094|TWO_SIDED|90.0|-33.79|-0.35|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||-0.35|-33.79|0.094
71942072|NCT03292653|143405378|SUPERIORITY||Difference in LS Means|-12.09|STANDARD_ERROR_OF_MEAN|8.49||0.1878|TWO_SIDED|90.0|-27.65|3.46|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.46|-27.65|0.1878
71942073|NCT03292653|143405379|SUPERIORITY||Difference in LS Means|-4.82|STANDARD_ERROR_OF_MEAN|5.8||0.4269|TWO_SIDED|90.0|-15.45|5.8|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||5.8|-15.45|0.4269
71942074|NCT03292653|143405379|SUPERIORITY||Difference in LS Means|-6.36|STANDARD_ERROR_OF_MEAN|5.39||0.2684|TWO_SIDED|90.0|-16.24|3.52|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||3.52|-16.24|0.2684
71942075|NCT03292653|143405380|SUPERIORITY||Difference in LS Means|847.2|STANDARD_ERROR_OF_MEAN|576.98||0.1761|TWO_SIDED|90.0|-210.46|1904.86|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1904.86|-210.46|0.1761
71942076|NCT03292653|143405380|SUPERIORITY||Difference in LS Means|489.33|STANDARD_ERROR_OF_MEAN|579.35||0.4202|TWO_SIDED|90.0|-572.68|1551.34|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline plasma volume as the covariate.||1551.34|-572.68|0.4202
71942077|NCT03292653|143405381|SUPERIORITY||Difference in LS Means|13.75|STANDARD_ERROR_OF_MEAN|8.53||0.1242|TWO_SIDED|90.0|-1.03|28.53|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||28.53|-1.03|0.1242
71942078|NCT03292653|143405381|SUPERIORITY||Difference in LS Means|0.1|STANDARD_ERROR_OF_MEAN|7.73||0.9903|TWO_SIDED|90.0|-13.49|13.3|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline erythropoietin as the covariate.||13.30|-13.49|0.9903
71693835|NCT01691378|142902169|SUPERIORITY||Mean Difference (Final Values)|4.4||||0.03|TWO_SIDED|95.0|0.52|8.3|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BHS compared bet arms controlling for T1 BHS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BHS as function of arm \& T1 BHS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.3|.52|.03
71693836|NCT01691378|142902169|SUPERIORITY||Mean Difference (Final Values)|-4.6||||0.01|TWO_SIDED|95.0|-7.9|-1.3|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-1.3|-7.9|.01
71693837|NCT01691378|142902169|SUPERIORITY||Mean Difference (Final Values)|-6.3||||0.0007|TWO_SIDED|95.0|-9.3|-3.2|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-3.2|-9.3|.0007
71693838|NCT01691378|142902170|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.07|TWO_SIDED|95.0|-0.29|8.0|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BSS compared bet arms controlling for T1 BSS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BSS as function of arm \& T1 BSS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||8.0|-.29|.07
71693839|NCT01691378|142902170|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.94|TWO_SIDED|95.0|-3.3|3.1|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||3.1|-3.3|.94
71693840|NCT01691378|142902170|SUPERIORITY||Mean Difference (Final Values)|-3.5||||0.06|TWO_SIDED|95.0|-7.0|0.12|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||.12|-7.0|.06
71693841|NCT01691378|142902171|SUPERIORITY||Mean Difference (Final Values)|5.6||||0.13|TWO_SIDED|95.0|-1.7|12.9|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum \& Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BDI compared bet arms controlling for T1 BDI. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BDI as function of arm \& T1 BDI. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."||12.9|-1.7|.13
71693842|NCT01691378|142902171|SUPERIORITY||Mean Difference (Final Values)|-8.7||||0.003|TWO_SIDED|95.0|-13.8|-3.6|||Regression, Linear|||"Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control \& only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough room to change in Intervention period). Linear regression used with difference in change as dependent variable \& Waitlist period change as only predictor. Estimated mean difference in change calculated from this model."||-3.6|-13.8|.003
71693843|NCT01691378|142902171|SUPERIORITY||Mean Difference (Final Values)|-11.6||||0.002|TWO_SIDED|95.0|-18.0|-5.3|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.||-5.3|-18.0|.002
71693844|NCT02155985|142902180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.7|TWO_SIDED|95.0|-5.5|8.8||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||8.8|-5.5|0.70
71942079|NCT03292653|143405382|SUPERIORITY||Difference in LS Means|-150.89|STANDARD_ERROR_OF_MEAN|116.09||0.2121|TWO_SIDED|90.0|-353.57|51.78|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||51.78|-353.57|0.2121
71942080|NCT03292653|143405382|SUPERIORITY||Difference in LS Means|-5.26|STANDARD_ERROR_OF_MEAN|96.88||0.9574|TWO_SIDED|90.0|-174.4|163.87|||ANCOVA|||ANCOVA model with fixed effects for treatment and stratification factors of baseline participant status (diabetic/non-diabetic), ejection fraction status (reduced/preserved) with baseline NT-proBNP as the covariate.||163.87|-174.4|0.9574
71942081|NCT03311646|143405388|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.07||||0.92|TWO_SIDED|95.0|-1.27|1.4||alpha=0.05.|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p-value: p=0.27|1.4|-1.27|0.92
71942082|NCT03311646|143405389|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|1.13||||0.15|TWO_SIDED|95.0|-0.41|2.66||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.|Interaction p=0.23|2.66|-0.41|0.15
71942083|NCT03311646|143405390|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|3.19|||<|0.001|TWO_SIDED|95.0|1.77|4.6|||Mixed Models Analysis||Mean Difference=VLNC-NNC|Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.|Interaction p=0.95|4.60|1.77|<0.001
71942084|NCT03311646|143405391|OTHER|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.2||||0.84|TWO_SIDED|95.0|-2.0|2.5||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p=0.94|2.5|-2.0|0.84
71942085|NCT03765502|143405393|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
71942086|NCT03765502|143405394|SUPERIORITY||||||<|0.0001|||||||McNemar|Crossover design: paired test||||||<.0001
71942087|NCT00683020|143405400|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|0.9||0.03|TWO_SIDED|95.0|0.1|3.9|||Regression, Linear|Adjusted for baseline values.||||3.9|0.1|0.03
71942088|NCT00683020|143405401|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.4|STANDARD_ERROR_OF_MEAN|1.2||0.23|TWO_SIDED|95.0|-0.9|3.6|||Regression, Linear|Adjusted for baseline values.||||3.6|-0.9|0.23
71942089|NCT00683020|143405402|NON_INFERIORITY_OR_EQUIVALENCE|Days in comparison groups are not equal.|Rate Ratio|0.6||||0.25|TWO_SIDED|95.0|0.3|1.4|||Negative Binomial Models|Adjusted for baseline values.||||1.4|0.3|0.25
71942090|NCT00683020|143405403|NON_INFERIORITY_OR_EQUIVALENCE|Proportions in comparison groups are not equal.|Odds Ratio (OR)|0.5||||0.18|TWO_SIDED|95.0|0.2|1.4|||Regression, Logistic|Adjusted for baseline values.||||1.4|0.2|0.18
71942091|NCT00683020|143405404|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.1||0.008|TWO_SIDED|95.0|0.1|0.5|||Regression, Linear|Adjusted for baseline values.||||0.5|0.1|0.008
71942092|NCT00683020|143405405|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.87|TWO_SIDED|95.0|-0.2|0.2|||Regression, Linear|Adjusted for baseline values.||||0.2|-0.2|0.87
71942093|NCT00683020|143405406|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.6||0.49|TWO_SIDED|95.0|-2.1|4.2|||Regression, Linear|Adjusted for baseline values.||||4.2|-2.1|0.49
71942094|NCT00683020|143405407|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.3|STANDARD_ERROR_OF_MEAN|2.2||0.54|TWO_SIDED|95.0|-3.0|5.6|||Regression, Linear|Adjusted for baseline values.||||5.6|-3.0|0.54
71942095|NCT00683020|143405408|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|STANDARD_ERROR_OF_MEAN|1.2||0.11|TWO_SIDED|95.0|-0.4|4.4|||Regression, Linear|Adjusted for baseline values.||||4.4|-0.4|0.11
71942096|NCT00683020|143405409|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.13|TWO_SIDED|95.0|-0.6|0.1|||Regression, Linear|Adjusted for baseline values.||||0.1|-0.6|0.13
71942097|NCT00683020|143405410|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.3||0.78|TWO_SIDED|95.0|-3.8|5.1|||Regression, Linear|Adjusted for baseline values.||||5.1|-3.8|0.78
71942098|NCT00683020|143405411|NON_INFERIORITY_OR_EQUIVALENCE|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.1|STANDARD_ERROR_OF_MEAN|1.4||0.13|TWO_SIDED|95.0|-0.6|4.9|||Regression, Linear|Adjusted for baseline values.||||4.9|-0.6|0.13
71942099|NCT03127137|143405412|SUPERIORITY|||||||0.05||||||The reported p-value was calculated.|Fisher Exact|||||||.05
71942100|NCT03127137|143405413|SUPERIORITY||Risk Ratio (RR)|1.53|||||TWO_SIDED|95.0|0.82|2.86||||||||2.86|.82|
71942101|NCT03657160|143405428|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|0.001|TWO_SIDED|95.0|0.27|0.73|||Log Rank|||||0.73|0.27|<0.001
71942102|NCT03657160|143405429|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.86|||Log Rank|||||0.86|0.37|0.0043
71942103|NCT03657160|143405430|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.0204|TWO_SIDED|95.0|0.39|0.91|||Log Rank|||||0.91|0.39|0.0204
71942104|NCT03657160|143405431|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.0668|TWO_SIDED|95.0|0.22|1.04|||Log Rank|||||1.04|0.22|0.0668
71942105|NCT03657160|143405432|SUPERIORITY||Hazard Ratio (HR)|0.63||||0.1458|TWO_SIDED|95.0|0.34|1.17|||Log Rank|||||1.17|0.34|0.1458
71942106|NCT03657160|143405433|SUPERIORITY||Hazard Ratio (HR)|0.64||||0.0105|TWO_SIDED|95.0|0.46|0.91|||Log Rank|||||0.91|0.46|0.0105
71693845|NCT02155985|142902180|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.5||||0.14|TWO_SIDED|95.0|-1.7|13.3||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) \* 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.||13.3|-1.7|0.14
71942107|NCT00440557|143405452|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.17|STANDARD_ERROR_OF_MEAN|0.106||||95.0|-0.38|0.037||This comparison between QW and TIW was performed prior to comparing Q2W with TIW in the statistical analysis 2 according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.||0.037|-0.380|
71693846|NCT03110133|142902200|SUPERIORITY|||||||0.0488|||||||Chi-squared|||||||0.0488
71693847|NCT03110133|142902203|SUPERIORITY|||||||0.0347|||||||Chi-squared|||||||0.0347
71693848|NCT02493517|142902249|NON_INFERIORITY|The non-inferiority margin is defined as 0.6 SDS for the upper limit of 95% CI of the LS mean difference of the log-transformed IGF-1 SDS without back-transformation.|Treatment difference|-0.32|||||TWO_SIDED|95.0|-0.74|0.11||||||"The Least Square (LS) Means and 95% Confidence Intervals (CIs) were based on the generalised linear model (GLM) with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The treatment difference (lanreotide Autogel - lanreotide PR) is presented."||0.11|-0.74|
71693849|NCT02493517|142902249|NON_INFERIORITY|The non-inferiority margin for the back-transformed LS Mean ratio of IGF-1 SDS of lanreotide Autogel versus lanreotide PR is exp (0.6) = 1.822.|LS Mean ratio|0.73|||||TWO_SIDED|95.0|0.48|1.11||||||"The LS Means and 95% CIs were based on the GLM with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The LS Mean ratio (lanreotide Autogel versus lanreotide PR) is presented."||1.11|0.48|
71693850|NCT02493517|142902250|OTHER||Risk Difference (RD)|6.3|||||TWO_SIDED|95.0|-5.2|17.7||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of normal IGF-1 SDS values at EOST/EW Visit is presented.||17.7|-5.2|
71693851|NCT02493517|142902251|OTHER||Risk Difference (RD)|-1.6|||||TWO_SIDED|95.0|-17.5|14.4||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤2.5 mcg/L at EOST/EW Visit is presented.||14.4|-17.5|
71693852|NCT02493517|142902252|OTHER||Risk Difference (RD)|1.6|||||TWO_SIDED|95.0|-8.9|12.0||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤1 mcg/L at EOST/EW Visit is presented.||12.0|-8.9|
71693853|NCT02493517|142902253|OTHER||Risk Difference (RD)|4.7|||||TWO_SIDED|95.0|-3.1|12.5||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage subjects with normal IGF-1 levels and who have GH levels \>1 mcg/L and ≤2.5 mcg/L at EOST/EW Visit is presented.||12.5|-3.1|
71942108|NCT00440557|143405452|NON_INFERIORITY_OR_EQUIVALENCE|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.43|STANDARD_ERROR_OF_MEAN|0.107||||95.0|-0.641|-0.221||Since the non-inferiority was declared in the statistical analysis 1, this comparison between Q2W and TIW was then performed according to a planned stepdown procedure for controlling multiplicity.||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.||-0.221|-0.641|
71942109|NCT00440557|143405453|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-7.8||||||95.0|-17.2|1.7||||||||1.7|-17.2|
71942110|NCT00440557|143405453|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-15.0||||||95.0|-25.0|-5.0||||||||-5.0|-25.0|
71942111|NCT00440557|143405454|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.26||||||95.0|-0.564|0.043|||ANOVA|||||0.043|-0.564|
71693854|NCT02493517|142902254|OTHER||Treatment difference|3.63|STANDARD_DEVIATION|21.6|||TWO_SIDED|95.0|-3.98|11.25||||||Treatment difference (lanreotide Autogel - lanreotide PR) is presented.||11.25|-3.98|
71693855|NCT02493517|142902255|OTHER||Risk Difference (RD)|-5.5|||||TWO_SIDED|95.0|-24.3|13.3||||||Risk difference (lanreotide Autogel - lanreotide PR) in the percentage of subjects with at least 20% reduction in the solid component of tumour volume compared to Baseline is presented.||13.3|-24.3|
71693856|NCT03718429|142902264|SUPERIORITY|In line with recommendations for pilot investigations, since there were no preliminary data exploring the pharmacodynamic effects of vascular dose rivaroxaban in addition to antiplatelet therapy, we arbitrarily chose a sample size of 20 patients per treatment cohort.||||||0.275|||||||Wilcoxon (Mann-Whitney)|||||||0.275
71942112|NCT00440557|143405454|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.45||||||95.0|-0.755|-0.147|||ANOVA|||||-0.147|-0.755|
71942113|NCT00440557|143405455|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.9||||||95.0|-9.5|1.6||||||||1.6|-9.5|
71942114|NCT00440557|143405455|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-5.5||||||95.0|-11.4|0.3||||||||0.3|-11.4|
71942115|NCT00440557|143405456|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-2.7||||||95.0|-14.2|8.7||||||||8.7|-14.2|
71942116|NCT00440557|143405456|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-9.9||||||95.0|-21.7|1.8||||||||1.8|-21.7|
71693857|NCT03718429|142902265|SUPERIORITY|||||||0.488|||||||Wilcoxon (Mann-Whitney)|||||||0.488
71693858|NCT03718429|142902266|SUPERIORITY||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71693859|NCT00325819|142902283|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.66||||0.053|TWO_SIDED|95.0|0.41|1.01|||unadjusted Poisson regression|||The study sample size of 1000 children was selected to have 80% power to detect a 30% reduction in risk of the primary outcome of rectal temperature \>=38 following vaccination. In 2009, during the enrollment period of our trial, another paper reported the results of a randomized trial of acetaminophen prophylaxis in infants which found significantly lower immune responses to various vaccines in the acetaminophen group. In light of thse findings we elected to stop enrollment in our trial.||1.01|0.41|0.053
71942117|NCT00440557|143405457|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|2.6||||||95.0|-9.6|14.8||||||||14.8|-9.6|
71942118|NCT00440557|143405457|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-3.0||||||95.0|-15.0|9.0||||||||9.0|-15.0|
71693860|NCT00325819|142902284|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.0||||0.08||95.0|||||Fisher Exact|||||||0.08
71942119|NCT00440557|143405458|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|0.03||||||95.0|-0.21|0.27|||ANOVA|||||0.270|-0.210|
71942120|NCT00440557|143405458|SUPERIORITY_OR_OTHER||Difference of Least Squares Means|-0.07||||||95.0|-0.315|0.166|||ANOVA|||||0.166|-0.315|
71942121|NCT00440557|143405459|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-8.8||||||95.0|-16.0|-1.9||||||||-1.9|-16|
71942122|NCT00440557|143405459|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|-10.0||||||95.0|-18.0|-3.2||||||||-3.2|-18.0|
71942123|NCT02781727|143405476|NON_INFERIORITY|Non-inferiority comparison with a non-inferiority margin of 2 cm/year, followed by a test of superiority if non-inferiority is established.||||||0.0088||||||P-value is based on a test of superiority|ANCOVA with multiple imputation|two-sided||ANCOVA model with multiple imputation. For each imputed data set, an ANCOVA model with by visit AHV as the dependent variable; treatment and gender as factors; and baseline age, baseline peak GH levels (log transformed) at stimulation test, and baseline height SDS - average parental height SDS as covariates were fitted.||||0.0088
71942124|NCT01918800|143405485|SUPERIORITY_OR_OTHER|||||||0.64||||||No adjustment for multiple comparisons. A priori threshold for clinical significance was 7 point improvement.|paired t test|||||||.64
71942125|NCT01918800|143405486|SUPERIORITY_OR_OTHER|||||||0.04||||||No adjustments for multiple comparisons.|paired t test|||||||0.04
71942126|NCT01918800|143405487|SUPERIORITY_OR_OTHER|||||||0.35||||||No adjustment for multiple comparisons|Paired t test|||||||0.35
71942127|NCT01918800|143405488|SUPERIORITY|||||||0.8||||||The p value in this case is for the SF-36 Physical|Wilcoxon (Mann-Whitney)|||||||0.8
71693861|NCT00325819|142902285|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.31||||0.02|TWO_SIDED|95.0|0.12|0.84|||unadjusted Poisson regression|||||0.84|0.12|0.02
71693862|NCT00325819|142902286|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.45||||0.14|TWO_SIDED|95.0|0.16|1.28|||unadjusted Poisson regression|||||1.28|0.16|0.14
71693863|NCT00325819|142902287|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.4||||0.001|TWO_SIDED|95.0|0.25|0.7|||unadjusted Poisson regression|||||0.70|0.25|0.001
71693864|NCT00325819|142902288|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.62||||0.4|TWO_SIDED|95.0|0.21|1.88|||unadjusted Poisson regression|||||1.88|0.21|0.40
71693865|NCT00325819|142902289|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.25|3.94|||unadjusted Poisson regression|||||3.94|0.25|1.00
71942128|NCT01918800|143405488|SUPERIORITY|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||The p value in this case refers to the SF-36 Mental||||.09
71942129|NCT01918800|143405489|SUPERIORITY_OR_OTHER|||||||0.521||||||This p value applies to the RAPA Cardiovascular|Wilcoxon (Mann-Whitney)|||||||0.521
71942130|NCT01918800|143405489|SUPERIORITY|||||||0.4199|||||||Wilcoxon (Mann-Whitney)|||This p values is for the RAPA Strength||||0.4199
71942131|NCT01918800|143405489|SUPERIORITY|||||||0.854|||||||Wilcoxon (Mann-Whitney)|||||||0.854
71942132|NCT01918800|143405490|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||||||0.42
71942133|NCT01918800|143405491|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||||||0.36
71942134|NCT01706926|143405541|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.69|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.06|-0.31|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.31|-1.06|<0.001
71942135|NCT01706926|143405541|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.96|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.33|-0.58|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.58|-1.33|<0.001
71942136|NCT01706926|143405541|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.22|STANDARD_ERROR_OF_MEAN|0.193|<|0.001|TWO_SIDED|95.0|-1.6|-0.84|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||-0.84|-1.60|<0.001
71942137|NCT01706926|143405542|SUPERIORITY_OR_OTHER||Percent difference|25.9|||<|0.001|TWO_SIDED|95.0|11.5|40.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||40.3|11.5|<0.001
71942138|NCT01706926|143405542|SUPERIORITY_OR_OTHER||Percent difference|36.5|||<|0.001|TWO_SIDED|95.0|22.5|50.5|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||50.5|22.5|<0.001
71942139|NCT01706926|143405542|SUPERIORITY_OR_OTHER||Percent difference|48.7|||<|0.001|TWO_SIDED|95.0|35.2|62.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||62.3|35.2|<0.001
71942140|NCT01706926|143405549|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.013|TWO_SIDED|95.0|3.9|28.2|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||28.2|3.9|0.013
71942141|NCT01706926|143405549|SUPERIORITY_OR_OTHER||Percent difference|13.5||||0.03|TWO_SIDED|95.0|1.8|25.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||25.3|1.8|0.030
71693866|NCT00325819|142902290|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|2.94||||0.18|TWO_SIDED|95.0|0.6|14.34|||unadjusted Poisson regression|||||14.34|0.60|0.18
71693867|NCT03574974|142902323|SUPERIORITY|||||||0.047|||||||t-test, 2 sided|||||||0.047
71942142|NCT01706926|143405549|SUPERIORITY_OR_OTHER||Percent difference|28.2|||<|0.001|TWO_SIDED|95.0|15.2|41.1|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|||41.1|15.2|<0.001
71942143|NCT01706926|143405550|SUPERIORITY_OR_OTHER||Percent difference|8.6||||0.079|TWO_SIDED|95.0|0.4|16.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||16.9|0.4|0.079
71942144|NCT01706926|143405550|SUPERIORITY_OR_OTHER||Percent difference|6.9||||0.133|TWO_SIDED|95.0|-0.8|14.6|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||14.6|-0.8|0.133
71942145|NCT01706926|143405550|SUPERIORITY_OR_OTHER||Percent difference|10.2||||0.026|TWO_SIDED|95.0|1.5|18.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.|||18.9|1.5|0.026
71942146|NCT01706926|143405551|SUPERIORITY_OR_OTHER||Adjusted Mean difference|15.79|STANDARD_ERROR_OF_MEAN|6.007||0.009|TWO_SIDED|95.0|3.96|27.61|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||27.61|3.96|0.009
71942147|NCT01706926|143405551|SUPERIORITY_OR_OTHER||Adjusted mean difference|16.99|STANDARD_ERROR_OF_MEAN|5.879||0.004|TWO_SIDED|95.0|5.42|28.56|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||28.56|5.42|0.004
71942148|NCT01706926|143405551|SUPERIORITY_OR_OTHER||Adjusted mean difference|27.47|STANDARD_ERROR_OF_MEAN|5.892|<|0.001|TWO_SIDED|95.0|15.87|39.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences \<0 favored mavrilimumab.|||39.07|15.87|<0.001
71942149|NCT01706926|143405552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.7|||<|0.001|TWO_SIDED|95.0|2.56|8.8|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (\>) one favored mavrilimumab.|||8.80|2.56|<0.001
71942150|NCT01706926|143405552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.81|||<|0.001|TWO_SIDED|95.0|2.64|8.92|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|||8.92|2.64|<0.001
71942151|NCT01706926|143405552|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.11|||<|0.001|TWO_SIDED|95.0|3.85|13.4|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios \>one favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.||13.40|3.85|<0.001
71942152|NCT01706926|143405553|SUPERIORITY_OR_OTHER||Percent difference|16.0||||0.004|TWO_SIDED|95.0|6.0|26.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||26.1|6.0|0.004
71942153|NCT01706926|143405553|SUPERIORITY_OR_OTHER||Percent difference|12.7||||0.014|TWO_SIDED|95.0|3.3|22.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||22.1|3.3|0.014
71942154|NCT01706926|143405553|SUPERIORITY_OR_OTHER||Percent difference|14.0||||0.007|TWO_SIDED|95.0|4.2|23.9|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.||23.9|4.2|0.007
71942155|NCT01706926|143405553|SUPERIORITY_OR_OTHER||Percent difference|24.7|||<|0.001|TWO_SIDED|95.0|12.7|36.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||36.6|12.7|<0.001
71693868|NCT01466361|142902329|SUPERIORITY_OR_OTHER||Least square mean difference|-7.23||||0.0643|TWO_SIDED|95.0|-14.89|0.44|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.||0.44|-14.89|0.0643
71693869|NCT01466361|142902329|SUPERIORITY_OR_OTHER||Least square mean difference|-7.16||||0.1489|TWO_SIDED|95.0|-16.93|2.61|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.||2.61|-16.93|0.1489
71693870|NCT01466361|142902329|SUPERIORITY_OR_OTHER||Least square mean difference|-6.33||||0.2225|TWO_SIDED|95.0|-16.56|3.9|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.||3.90|-16.56|0.2225
71693871|NCT01466361|142902329|SUPERIORITY_OR_OTHER||Least square mean difference|-5.11||||0.3491|TWO_SIDED|95.0|-15.87|5.66|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.||5.66|-15.87|0.3491
71693872|NCT01466361|142902329|SUPERIORITY_OR_OTHER||Least square mean difference|-5.0||||0.3936|TWO_SIDED|95.0|-16.6|6.59|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.||6.59|-16.60|0.3936
71693873|NCT01466361|142902330|SUPERIORITY_OR_OTHER||Least square mean difference|-3.58||||0.3922|TWO_SIDED|95.0|-11.85|4.7|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.||4.70|-11.85|0.3922
71693874|NCT01466361|142902330|SUPERIORITY_OR_OTHER||Least square mean difference|-9.7||||0.0547|TWO_SIDED|95.0|-19.59|0.2|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.||0.20|-19.59|0.0547
71693875|NCT03506438|142902361|SUPERIORITY||Mean Difference (Net)|-6.7||||0.018|TWO_SIDED|95.0|-12.2|-1.2|||Mixed Models Analysis|||||-1.2|-12.2|0.018
71693876|NCT03506438|142902362|SUPERIORITY||Mean Difference (Net)|0.3||||0.48|TWO_SIDED|95.0|-0.5|1.1|||Mixed Models Analysis|||||1.1|-0.5|0.48
71693877|NCT03506438|142902363|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.73|TWO_SIDED|95.0|-1.4|1.0|||Mixed Models Analysis|||||1.0|-1.4|0.73
71693878|NCT03506438|142902364|SUPERIORITY||estimated mean difference|0.6||||0.47|TWO_SIDED|95.0|-1.0|2.1|||Mixed Models Analysis|||||2.1|-1.0|0.47
71693879|NCT03506438|142902365|SUPERIORITY||Odds Ratio (OR)|1.8||||0.29|TWO_SIDED|95.0|0.6|5.2|||Regression, Logistic|||||5.2|0.6|0.29
71693880|NCT03506438|142902366|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||||||0.47
71693881|NCT03506438|142902367|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||||||0.39
71693882|NCT03506438|142902368|SUPERIORITY|||||||0.08|||||||Regression, Logistic|||||||0.08
71693883|NCT03527277|142902369|SUPERIORITY||Mean Difference (Net)|-1.5||||0.46|TWO_SIDED|95.0|-5.7|2.6|||ANCOVA|Effect of group on change in outcome with adjustment for BMI, Outcome at baseline and gender||||2.6|-5.7|0.46
71693884|NCT03527277|142902370|SUPERIORITY||Mean Difference (Net)|-0.1||||0.97|TWO_SIDED|95.0|-3.1|3.0|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||3.0|-3.1|0.97
71693885|NCT03527277|142902371|SUPERIORITY||Mean Difference (Net)|-0.7||||0.73|TWO_SIDED|95.0|-4.8|3.4|||ANCOVA|Effect of group with adjustment for gender and outcome and BMI at baseline.||||3.4|-4.8|0.73
71693886|NCT03527277|142902372|SUPERIORITY||Mean Difference (Net)|1.0||||0.54|TWO_SIDED|95.0|-2.2|4.2|||ANCOVA|Effect of group change with adjustment for gender and BMI and outcome at baseline.||||4.2|-2.2|0.54
71693887|NCT03527277|142902373|SUPERIORITY||Mean Difference (Net)|-0.92|||<|0.0001|TWO_SIDED|95.0|-1.34|-0.49|||ANCOVA|Effect of group with adjustment for gender and BMI and outcome at baseline.||||-0.49|-1.34|<0.0001
71693888|NCT03527277|142902374|SUPERIORITY||Mean Difference (Net)|-0.86|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.53|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||-0.53|-1.19|<0.0001
71693889|NCT03527277|142902375|SUPERIORITY||Mean Difference (Net)|-0.38||||0.18|TWO_SIDED|95.0|-0.94|0.18|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.18|-0.94|0.18
71693890|NCT03527277|142902376|SUPERIORITY||Mean Difference (Net)|0.2||||0.49|TWO_SIDED|95.0|-0.38|0.77|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.77|-0.38|0.49
71693891|NCT03527277|142902377|SUPERIORITY||Mean Difference (Net)|-1.8||||0.66|TWO_SIDED|95.0|-10.1|6.5|||ANCOVA|Effect of group on change with adjustment of gender and BMI and outcome at baseline.||||6.5|-10.1|0.66
71693892|NCT03527277|142902378|SUPERIORITY||Mean Difference (Net)|-0.06||||0.78|TWO_SIDED|95.0|-0.06|0.35|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.35|-0.06|0.78
71693893|NCT03527277|142902379|SUPERIORITY||Mean Difference (Net)|0.03||||0.91|TWO_SIDED|95.0|-0.58|0.64|||ANCOVA|Effect of group on change with adjustment for gender and outcome and BMI at baseline.||||0.64|-0.58|0.91
71693894|NCT03527277|142902382|SUPERIORITY||Mean Difference (Net)|-7.9||||0.11|TWO_SIDED|95.0|-17.6|1.8|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||1.8|-17.6|0.11
71693895|NCT03527277|142902383|SUPERIORITY||Mean Difference (Net)|23340.0||||0.0032|TWO_SIDED|95.0|8284.0|38396.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||38396|8284|0.0032
71693896|NCT03527277|142902384|SUPERIORITY||Mean Difference (Net)|5558.0||||0.0003|TWO_SIDED|95.0|2680.0|8437.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||8437|2680|0.0003
71693897|NCT03527277|142902385|SUPERIORITY||Mean Difference (Net)|3824.0||||0.0012|TWO_SIDED|95.0|1611.0|6036.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline||||6036|1611|0.0012
71693898|NCT03527277|142902386|SUPERIORITY||Mean Difference (Net)|19522.0||||0.0023|TWO_SIDED|95.0|7353.0|31691.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||31691|7353|0.0023
71693899|NCT03527277|142902387|SUPERIORITY||Mean Difference (Net)|21881.0||||0.0001|TWO_SIDED|95.0|11307.0|32455.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||32455|11307|0.0001
71693900|NCT03527277|142902388|SUPERIORITY||Mean Difference (Net)|9666.0||||0.0002|TWO_SIDED|95.0|4808.0|14524.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||14524|4808|0.0002
71693901|NCT03527277|142902389|SUPERIORITY||Mean Difference (Net)|3413.0||||0.0011|TWO_SIDED|95.0|1456.0|5370.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5370|1456|0.0011
71693902|NCT03527277|142902390|SUPERIORITY||Mean Difference (Net)|11.6||||0.59|TWO_SIDED|95.0|-32.0|55.1|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||55.1|-32.0|0.59
71693903|NCT03527277|142902391|SUPERIORITY||Mean Difference (Net)|79.0||||0.028|TWO_SIDED|95.0|9.8|148.6|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||148.6|9.8|0.028
71693904|NCT03527277|142902393|SUPERIORITY||Mean Difference (Net)|-0.8||||0.17|TWO_SIDED|95.0|-1.94|0.35|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||0.35|-1.94|0.17
71693905|NCT03527277|142902394|SUPERIORITY||Mean Difference (Net)|0.54||||0.65|TWO_SIDED|95.0|-1.9|3.0|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||3.0|-1.9|0.65
71693906|NCT03527277|142902395|SUPERIORITY||Mean Difference (Net)|0.04||||0.88|TWO_SIDED|95.0|-0.5|0.6|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.6|-0.5|0.88
71693907|NCT03527277|142902396|SUPERIORITY||Mean Difference (Net)|0.6||||0.81|TWO_SIDED|95.0|-4.4|5.7|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||5.7|-4.4|0.81
71693908|NCT03527277|142902397|SUPERIORITY||Mean Difference (Net)|-0.7||||0.69|TWO_SIDED|95.0|-4.4|2.9|||ANCOVA|Effect of group on change with adjustment for gender and BMI and outcome at baseline.||||2.9|-4.4|0.69
71693909|NCT03527277|142902398|SUPERIORITY||Mean Difference (Net)|-0.4||||0.1|TWO_SIDED|95.0|-1.0|0.1|||ANCOVA|Effect of group on change with adjustment for gender and outcome at baseline.||||0.1|-1.0|0.10
71761225|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2||0.0005|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||-0.3|-0.9|0.0005
71942156|NCT01706926|143405553|SUPERIORITY_OR_OTHER||Percent difference|23.1|||<|0.001|TWO_SIDED|95.0|11.5|34.8|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||34.8|11.5|<0.001
71942157|NCT01706926|143405553|SUPERIORITY_OR_OTHER||Percent difference|33.1|||<|0.001|TWO_SIDED|95.0|20.7|45.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.||45.6|20.7|<0.001
71942158|NCT01706926|143405554|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.68|STANDARD_ERROR_OF_MEAN|1.237|<|0.001|TWO_SIDED|95.0|-8.12|-3.24|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.24|-8.12|<0.001
71942159|NCT01706926|143405554|SUPERIORITY_OR_OTHER||Adjusted mean difference|-6.21|STANDARD_ERROR_OF_MEAN|1.211|<|0.001|TWO_SIDED|95.0|-8.6|-3.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-3.82|-8.60|<0.001
71942160|NCT01706926|143405554|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.0|STANDARD_ERROR_OF_MEAN|1.219|<|0.001|TWO_SIDED|95.0|-9.4|-4.59|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.||-4.59|-9.40|<0.001
71942161|NCT01706926|143405554|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.24|STANDARD_ERROR_OF_MEAN|1.922|<|0.001|TWO_SIDED|95.0|-11.02|-3.45|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-3.45|-11.02|<0.001
71942162|NCT01706926|143405554|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.45|STANDARD_ERROR_OF_MEAN|1.884|<|0.001|TWO_SIDED|95.0|-12.16|-4.74|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-4.74|-12.16|<0.001
71942163|NCT01706926|143405554|SUPERIORITY_OR_OTHER||Adjusted mean difference|-10.42|STANDARD_ERROR_OF_MEAN|1.901|<|0.001|TWO_SIDED|95.0|-14.17|-6.67|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.||-6.67|-14.17|<0.001
71942164|NCT01706926|143405555|SUPERIORITY_OR_OTHER||Adjusted mean difference|-7.94|STANDARD_ERROR_OF_MEAN|3.95||0.045|TWO_SIDED|95.0|-15.72|-0.17|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.17|-15.72|0.045
71942165|NCT01706926|143405555|SUPERIORITY_OR_OTHER||Adjusted mean difference|-8.11|STANDARD_ERROR_OF_MEAN|3.876||0.037|TWO_SIDED|95.0|-15.73|-0.48|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.48|-15.73|0.037
71693910|NCT04155463|142902409|OTHER||Median Percent Change|-18.4||||0.17|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for all participants. Interquartile range for this was -37.4 to 29.8.|Based on previous pesticide research, we calculated a sample size of 40 participants to provide a power of 0.80 at a 0.05 significance level in a two-sided test. We assumed a standard deviation of 0.5 µg/L.||||0.17
71693911|NCT04155463|142902409|OTHER||Median Percent Change|-24.2||||0.06|TWO_SIDED||||||Wilcoxon signed rank test|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for far-field participants. Interquartile range for this was -37.4 to -8.8.|||||0.06
71693912|NCT04155463|142902409|OTHER||Median Percent Change|1.4||||0.83|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|Two-tailed test for paired data|This calculation shows the median percent change in urinary glyphosate concentrations going from the conventional diet to organic diet for near-field participants. Interquartile range for this was -41.9 to 43.0.|||||0.83
71693913|NCT02035553|142902475|SUPERIORITY||Diff in MMRM LSM|-1.84||||0.0451|TWO_SIDED|95.0|-3.64|-0.04|||Mixed Models Analysis|||||-0.04|-3.64|0.0451
71693914|NCT02326272|142902476|SUPERIORITY||Odds Ratio (OR)|33.405|||<|0.0001|TWO_SIDED|97.5|9.965|111.983||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||111.983|9.965|<0.0001
71693915|NCT02326272|142902476|SUPERIORITY||Estimated difference in responder rate|69.7|||||TWO_SIDED|95.0|57.12|82.36|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||82.36|57.12|
71693916|NCT02326272|142902476|SUPERIORITY||Odds Ratio (OR)|36.212|||<|0.0001|TWO_SIDED|97.5|10.686|122.713||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||122.713|10.686|<0.0001
71693917|NCT02326272|142902476|SUPERIORITY||Estimated difference in responder rate|71.0|||||TWO_SIDED|95.0|58.47|83.43|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||83.43|58.47|
71693918|NCT02326272|142902477|SUPERIORITY||Odds Ratio (OR)|106.225|||<|0.0001|TWO_SIDED|97.5|9.572|1178.843||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1178.843|9.572|<0.0001
71693919|NCT02326272|142902477|SUPERIORITY||Estimated difference in responder rate|64.8|||||TWO_SIDED|95.0|52.16|77.46|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||77.46|52.16|
71693920|NCT02326272|142902477|SUPERIORITY||Odds Ratio (OR)|133.163|||<|0.0001|TWO_SIDED|97.5|11.904|1489.578||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||1489.578|11.904|<0.0001
71693921|NCT02326272|142902477|SUPERIORITY||Estimated difference in responder rate|69.6|||||TWO_SIDED|95.0|57.48|81.77|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||81.77|57.48|
71693922|NCT02326272|142902478|SUPERIORITY||Odds Ratio (OR)|24.283|||<|0.0001|TWO_SIDED|97.5|4.386|134.432||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||134.432|4.386|<0.0001
71693923|NCT02326272|142902478|SUPERIORITY||Estimated difference in responder rate|48.1|||||TWO_SIDED|95.0|35.04|61.26|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||61.26|35.04|
71693924|NCT02326272|142902478|SUPERIORITY||Odds Ratio (OR)|27.204|||<|0.0001|TWO_SIDED|97.5|4.895|151.198||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||151.198|4.895|<0.0001
71693925|NCT02326272|142902478|SUPERIORITY||Estimated difference in responder rate|51.0|||||TWO_SIDED|95.0|37.75|64.19|||Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||64.19|37.75|
71693926|NCT02326272|142902481|SUPERIORITY||Adjusted Mean Treatment Differences|-6.62|||<|0.0001|TWO_SIDED|97.5|-8.88|-4.36||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-4.36|-8.88|<0.0001
71693927|NCT02326272|142902481|SUPERIORITY||Adjusted Mean Treatment Differences|-6.19|||<|0.0001|TWO_SIDED|97.5|-8.46|-3.93||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.||-3.93|-8.46|<0.0001
71693928|NCT02185417|142902489|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.45|TWO_SIDED|95.0|0.94|1.16|||Log Rank|||Primary analyses were performed with the use of unadjusted log-rank tests that were stratified according to VA health care system.||1.16|0.94|0.45
71693929|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-1.54||||0.2968|TWO_SIDED|95.0|-4.44|1.37|||Student's paired t-test|||Change from Baseline at Day 1||1.37|-4.44|0.2968
71942166|NCT01706926|143405555|SUPERIORITY_OR_OTHER||Adjusted mean difference|-11.32|STANDARD_ERROR_OF_MEAN|3.899||0.004|TWO_SIDED|95.0|-19.0|-3.65|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-3.65|-19.00|0.004
71942167|NCT01706926|143405556|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.85|STANDARD_ERROR_OF_MEAN|4.137||0.837|TWO_SIDED|95.0|-8.99|7.29|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||7.29|-8.99|0.837
71942168|NCT01706926|143405556|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.19|STANDARD_ERROR_OF_MEAN|4.058||0.589|TWO_SIDED|95.0|-10.18|5.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||5.79|-10.18|0.589
71942169|NCT01706926|143405556|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.48|STANDARD_ERROR_OF_MEAN|4.083||0.18|TWO_SIDED|95.0|-13.52|2.55|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||2.55|-13.52|0.180
71942170|NCT01706926|143405557|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.41|STANDARD_ERROR_OF_MEAN|0.397|<|0.001|TWO_SIDED|95.0|-2.2|-0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.63|-2.20|<0.001
71942171|NCT01706926|143405557|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.46|STANDARD_ERROR_OF_MEAN|0.389|<|0.001|TWO_SIDED|95.0|-2.23|-0.69|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.69|-2.23|<0.001
71942172|NCT01706926|143405557|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.56|STANDARD_ERROR_OF_MEAN|0.391|<|0.001|TWO_SIDED|95.0|-2.33|-0.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.79|-2.33|<0.001
71942173|NCT01706926|143405558|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.479|TWO_SIDED|95.0|-0.29|0.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.14|-0.29|0.479
71942174|NCT01706926|143405558|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.16|STANDARD_ERROR_OF_MEAN|0.106||0.124|TWO_SIDED|95.0|-0.37|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||0.04|-0.37|0.124
71942175|NCT01706926|143405558|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.26|STANDARD_ERROR_OF_MEAN|0.107||0.017|TWO_SIDED|95.0|-0.47|-0.05|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \<0 favored mavrilimumab.|||-0.05|-0.47|0.017
71942176|NCT01706926|143405559|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.64||||0.017|TWO_SIDED|95.0|0.45|0.92|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.92|0.45|0.017
71942177|NCT01706926|143405559|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.46|||<|0.001|TWO_SIDED|95.0|0.32|0.66|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.66|0.32|<0.001
71942178|NCT01706926|143405559|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.44|||<|0.001|TWO_SIDED|95.0|0.31|0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.63|0.31|<0.001
71693930|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-15.36|||<|0.0001|TWO_SIDED|95.0|-19.77|-10.95|||Student's paired t-test|||Change from Baseline at Day 2||-10.95|-19.77|<.0001
71693931|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-27.27|||<|0.0001|TWO_SIDED|95.0|-33.06|-21.49|||Student's paired t-test|||Change from Baseline at Day 3||-21.49|-33.06|<.0001
71693932|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-35.05|||<|0.0001|TWO_SIDED|95.0|-41.69|-28.41|||Student's paired t-test|||Change from Baseline at Day 4||-28.41|-41.69|<.0001
71693933|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-38.49|||<|0.0001|TWO_SIDED|95.0|-45.87|-31.11|||Student's paired t-test|||Change from Baseline at Day 5||-31.11|-45.87|<.0001
71693934|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-39.67|||<|0.0001|TWO_SIDED|95.0|-48.46|-30.88|||Student's paired t-test|||Change from Baseline at Day 6||-30.88|-48.46|<.0001
71693935|NCT05556148|142902497|OTHER||Mean Difference (Final Values)|-52.6|||<|0.0001|TWO_SIDED|95.0|-63.69|-41.51|||Student's paired t-test|||Change from Baseline at Day 7||-41.51|-63.69|<.0001
71942179|NCT01706926|143405560|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.72||||0.003|TWO_SIDED|95.0|0.58|0.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.89|0.58|0.003
71942180|NCT01706926|143405560|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.68|||<|0.001|TWO_SIDED|95.0|0.55|0.84|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.84|0.55|<0.001
71942181|NCT01706926|143405560|SUPERIORITY_OR_OTHER||Adjusted geometric mean ratio|0.61|||<|0.001|TWO_SIDED|95.0|0.49|0.75|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio \<1 favored mavrilimumab.|||0.75|0.49|<0.001
71942182|NCT01706926|143405561|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
71942183|NCT01706926|143405561|SUPERIORITY_OR_OTHER||Percent difference|1.1||||1|TWO_SIDED|95.0|-2.9|5.1|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||5.1|-2.9|1.000
71942184|NCT01706926|143405561|SUPERIORITY_OR_OTHER||Percent difference|3.8||||0.207|TWO_SIDED|95.0|-1.6|9.2|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||9.2|-1.6|0.207
71942185|NCT01706926|143405562|SUPERIORITY_OR_OTHER||Percent difference|4.9||||0.21|TWO_SIDED|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||10.7|-0.8|0.210
71942186|NCT01706926|143405562|SUPERIORITY_OR_OTHER||Percent difference|2.3||||0.621|TWO_SIDED|95.0|-2.3|6.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||6.9|-2.3|0.621
71942187|NCT01706926|143405562|SUPERIORITY_OR_OTHER||Percent difference|6.4||||0.062|TWO_SIDED|95.0|0.0|12.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||12.7|0.0|0.062
71942188|NCT01706926|143405563|SUPERIORITY_OR_OTHER||Percent difference|3.7||||0.245|TWO_SIDED|95.0|-0.4|7.8|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||7.8|-0.4|0.245
71693936|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|0.29||||0.7112|TWO_SIDED|95.0|-1.27|1.86|||Student's paired t-test|||Change from Baseline at Day 1||1.86|-1.27|0.7112
71942189|NCT01706926|143405563|SUPERIORITY_OR_OTHER||Percent difference|1.2||||1|TWO_SIDED|95.0|-1.1|3.5|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.5|-1.1|1.000
71693937|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|-6.21|||<|0.0001|TWO_SIDED|95.0|-8.51|-3.92|||Student's paired t-test|||Change from Baseline at Day 2||-3.92|-8.51|<.0001
71693938|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|-12.11|||<|0.0001|TWO_SIDED|95.0|-15.0|-9.22|||Student's paired t-test|||Change from Baseline at Day 3||-9.22|-15.00|<.0001
71693939|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|-15.98|||<|0.0001|TWO_SIDED|95.0|-19.24|-12.71|||Student's paired t-test|||Change from Baseline at Day 4||-12.71|-19.24|<.0001
71942190|NCT01706926|143405563|SUPERIORITY_OR_OTHER||Percent difference|1.3||||0.494|TWO_SIDED|95.0|-1.2|3.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences \>0 favored mavrilimumab.|||3.7|-1.2|0.494
71942191|NCT01706926|143405564|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.18|STANDARD_ERROR_OF_MEAN|1.608||0.463|TWO_SIDED|95.0|-1.99|4.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||4.35|-1.99|0.463
71942192|NCT01706926|143405564|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.27|STANDARD_ERROR_OF_MEAN|1.574||0.151|TWO_SIDED|95.0|-0.83|5.37|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||5.37|-0.83|0.151
71942193|NCT01706926|143405564|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.92|STANDARD_ERROR_OF_MEAN|1.578||0.014|TWO_SIDED|95.0|0.81|7.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences \>0 favored mavrilimumab.|||7.02|0.81|0.014
71942194|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-2.2|1.0||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.0|-2.2|
71942195|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-4.0|3.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.||3.8|-4.0|
71942196|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.4|-1.6|
71942197|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.||1.4|-1.6|
71942198|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.9||||||95.0|-5.0|2.9||||||For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.||2.9|-5.0|
71693940|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|-19.44|||<|0.0001|TWO_SIDED|95.0|-23.29|-15.59|||Student's paired t-test|||Change from Baseline at Day 5||-15.59|-23.29|<.0001
71693941|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|-19.36|||<|0.0001|TWO_SIDED|95.0|-24.03|-14.69|||Student's paired t-test|||Change from Baseline at Day 6||-14.69|-24.03|<.0001
71693942|NCT05556148|142902498|OTHER||Mean Difference (Final Values)|-25.4|||<|0.0001|TWO_SIDED|95.0|-31.87|-18.93|||Student's paired t-test|||Change from Baseline at Day 7||-18.93|-31.87|<.0001
71693943|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-1.83||||0.0481|TWO_SIDED|95.0|-3.64|-0.02|||Student's paired t-test|||Change from Baseline at Day 1||-0.02|-3.64|0.0481
71693944|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-9.14|||<|0.0001|TWO_SIDED|95.0|-11.74|-6.55|||Student's paired t-test|||Change from Baseline at Day 2||-6.55|-11.74|<.0001
71693945|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-15.16|||<|0.0001|TWO_SIDED|95.0|-18.44|-11.88|||Student's paired t-test|||Change from Baseline at Day 3||-11.88|-18.44|<.0001
71693946|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-19.07|||<|0.0001|TWO_SIDED|95.0|-22.84|-15.3|||Student's paired t-test|||Change from Baseline at Day 4||-15.30|-22.84|<.0001
71693947|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-19.05|||<|0.0001|TWO_SIDED|95.0|-23.35|-14.75|||Student's paired t-test|||Change from Baseline at Day 5||-14.75|-23.35|<.0001
71693948|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-20.31|||<|0.0001|TWO_SIDED|95.0|-25.7|-14.92|||Student's paired t-test|||Change from Baseline at Day 6||-14.92|-25.70|<.0001
71693949|NCT05556148|142902499|OTHER||Mean Difference (Final Values)|-27.2|||<|0.0001|TWO_SIDED|95.0|-32.48|-21.92|||Student's paired t-test|||Change from Baseline at Day 7||-21.92|-32.48|<.0001
71693950|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-0.31|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.31|1.0000
71693951|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|-0.63||||0.0003|TWO_SIDED|95.0|-0.97|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-0.97|0.0003
71693952|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.5|-0.7|||Student's paired t-test|||Change from Baseline at Day 3||-0.70|-1.50|<.0001
71942199|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.5|1.4||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.4|-1.5|
71942200|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-7.8|1.0||||||For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.||1.0|-7.8|
71693953|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.2|-1.24|||Student's paired t-test|||Change from Baseline at Day 4||-1.24|-2.20|<.0001
71693954|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|-1.75|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.16|||Student's paired t-test|||Change from Baseline at Day 5||-1.16|-2.33|<.0001
71693955|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.28|||Student's paired t-test|||Change from Baseline at Day 6||-1.28|-2.51|<.0001
71693956|NCT05556148|142902500|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.29|-1.64|||Student's paired t-test|||Change from Baseline at Day 7||-1.64|-3.29|<.0001
71693957|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-0.39||||0.0023|TWO_SIDED|95.0|-0.64|-0.14|||Student's paired t-test|||Change from Baseline at Day 1||-0.14|-0.64|0.0023
71693958|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-1.47|||<|0.0001|TWO_SIDED|95.0|-1.82|-1.12|||Student's paired t-test|||Change from Baseline at Day 2||-1.12|-1.82|<.0001
71693959|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-1.99|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.58|||Student's paired t-test|||Change from Baseline at Day 3||-1.58|-2.40|<.0001
71693960|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-2.43|||<|0.0001|TWO_SIDED|95.0|-2.86|-2.0|||Student's paired t-test|||Change from Baseline at Day 4||-2.00|-2.86|<.0001
71693961|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-3.0|||<|0.0001|TWO_SIDED|95.0|-3.51|-2.49|||Student's paired t-test|||Change from Baseline at Day 5||-2.49|-3.51|<.0001
71693962|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-2.77|||<|0.0001|TWO_SIDED|95.0|-3.36|-2.18|||Student's paired t-test|||Change from Baseline at Day 6||-2.18|-3.36|<.0001
71693963|NCT05556148|142902501|OTHER||Mean Difference (Final Values)|-3.33|||<|0.0001|TWO_SIDED|95.0|-4.1|-2.57|||Student's paired t-test|||Change from Baseline at Day 7||-2.57|-4.10|<.0001
71693964|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-0.11||||0.4495|TWO_SIDED|95.0|-0.4|0.18|||Student's paired t-test|||Change from Baseline at Day 1||0.18|-0.40|0.4495
71693965|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-0.87|||<|0.0001|TWO_SIDED|95.0|-1.19|-0.54|||Student's paired t-test|||Change from Baseline at Day 2||-0.54|-1.19|<.0001
71693966|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-1.21|||<|0.0001|TWO_SIDED|95.0|-1.59|-0.82|||Student's paired t-test|||Change from Baseline at Day 3||-0.82|-1.59|<.0001
71693967|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-1.59|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.12|||Student's paired t-test|||Change from Baseline at Day 4||-1.12|-2.05|<.0001
71693968|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-1.86|||<|0.0001|TWO_SIDED|95.0|-2.4|-1.33|||Student's paired t-test|||Change from Baseline at Day 5||-1.33|-2.40|<.0001
71693969|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-1.85|||<|0.0001|TWO_SIDED|95.0|-2.45|-1.24|||Student's paired t-test|||Change from Baseline at Day 6||-1.24|-2.45|<.0001
71693970|NCT05556148|142902502|OTHER||Mean Difference (Final Values)|-2.47|||<|0.0001|TWO_SIDED|95.0|-3.19|-1.75|||Student's paired t-test|||Change from Baseline at Day 7||-1.75|-3.19|<.0001
71693971|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|0.11||||0.4758|TWO_SIDED|95.0|-0.2|0.42|||Student's paired t-test|||Change from Baseline at Day 1||0.42|-0.20|0.4758
71693972|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|-0.61||||0.0016|TWO_SIDED|95.0|-0.99|-0.24|||Student's paired t-test|||Change from Baseline at Day 2||-0.24|-0.99|0.0016
71693973|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|-1.23|||<|0.0001|TWO_SIDED|95.0|-1.67|-0.79|||Student's paired t-test|||Change from Baseline at Day 3||-0.79|-1.67|<.0001
71693974|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|-1.67|||<|0.0001|TWO_SIDED|95.0|-2.18|-1.16|||Student's paired t-test|||Change from Baseline at Day 4||-1.16|-2.18|<.0001
71693975|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.46|-1.51|||Student's paired t-test|||Change from Baseline at Day 5||-1.51|-2.46|<.0001
71693976|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.77|-1.39|||Student's paired t-test|||Change from Baseline at Day 6||-1.39|-2.77|<.0001
71693977|NCT05556148|142902503|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.65|-2.08|||Student's paired t-test|||Change from Baseline at Day 7||-2.08|-3.65|<.0001
71693978|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-0.04||||0.8017|TWO_SIDED|95.0|-0.36|0.28|||Student's paired t-test|||Change from Baseline at Day 1||0.28|-0.36|0.8017
71693979|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-0.67||||0.0005|TWO_SIDED|95.0|-1.05|-0.3|||Student's paired t-test|||Change from Baseline at Day 2||-0.30|-1.05|0.0005
71693980|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.69|-0.89|||Student's paired t-test|||Change from Baseline at Day 3||-0.89|-1.69|<.0001
71693981|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-1.41|||<|0.0001|TWO_SIDED|95.0|-1.86|-0.97|||Student's paired t-test|||Change from Baseline at Day 4||-0.97|-1.86|<.0001
71693982|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.5|-1.47|||Student's paired t-test|||Change from Baseline at Day 5||-1.47|-2.50|<.0001
71693983|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-1.95|||<|0.0001|TWO_SIDED|95.0|-2.61|-1.29|||Student's paired t-test|||Change from Baseline at Day 6||-1.29|-2.61|<.0001
71693984|NCT05556148|142902504|OTHER||Mean Difference (Final Values)|-2.4|||<|0.0001|TWO_SIDED|95.0|-3.26|-1.54|||Student's paired t-test|||Change from Baseline at Day 7||-1.54|-3.26|<.0001
71693985|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|0.03||||0.8311|TWO_SIDED|95.0|-0.25|0.31|||Student's paired t-test|||Change from Baseline at Day 1||0.31|-0.25|0.8311
71942201|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-3.6|5.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||5.0|-3.6|
71693986|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|-0.41||||0.0313|TWO_SIDED|95.0|-0.78|-0.04|||Student's paired t-test|||Change from Baseline at Day 2||-0.04|-0.78|0.0313
71693987|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|-0.84||||0.0003|TWO_SIDED|95.0|-1.28|-0.39|||Student's paired t-test|||Change from Baseline at Day 3||-0.39|-1.28|0.0003
71942202|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.2||||||95.0|-9.1|2.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.||2.4|-9.1|
71942203|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-8.2|9.5||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||9.5|-8.2|
71942204|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.8|1.6||||||For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||1.6|-1.8|
71693988|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|-1.05|||<|0.0001|TWO_SIDED|95.0|-1.51|-0.59|||Student's paired t-test|||Change from Baseline at Day 4||-0.59|-1.51|<.0001
71693989|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.74|-0.66|||Student's paired t-test|||Change from Baseline at Day 5||-0.66|-1.74|<.0001
71693990|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|-1.05||||0.0018|TWO_SIDED|95.0|-1.69|-0.42|||Student's paired t-test|||Change from Baseline at Day 6||-0.42|-1.69|0.0018
71693991|NCT05556148|142902505|OTHER||Mean Difference (Final Values)|-1.27||||0.0041|TWO_SIDED|95.0|-2.1|-0.43|||Student's paired t-test|||Change from Baseline at Day 7||-0.43|-2.10|0.0041
71693992|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|0.01||||0.938|TWO_SIDED|95.0|-0.25|0.27|||Student's paired t-test|||Change from Baseline at Day 1||0.27|-0.25|0.9380
71693993|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|-0.37||||0.0416|TWO_SIDED|95.0|-0.72|-0.01|||Student's paired t-test|||Change from Baseline at Day 2||-0.01|-0.72|0.0416
71693994|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|-0.96|||<|0.0001|TWO_SIDED|95.0|-1.29|-0.62|||Student's paired t-test|||Change from Baseline at Day 3||-0.62|-1.29|<.0001
71693995|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|-1.18|||<|0.0001|TWO_SIDED|95.0|-1.6|-0.76|||Student's paired t-test|||Change from Baseline at Day 4||-0.76|-1.60|<.0001
71693996|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.27|||Student's paired t-test|||Change from Baseline at Day 5||-1.27|-2.25|<.0001
71693997|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|-1.69|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.05|||Student's paired t-test|||Change from Baseline at Day 6||-1.05|-2.33|<.0001
71693998|NCT05556148|142902506|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-3.08|-1.52|||Student's paired t-test|||Change from Baseline at Day 7||-1.52|-3.08|<.0001
71693999|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|0.04||||0.7821|TWO_SIDED|95.0|-0.25|0.33|||Student's paired t-test|||Change from Baseline at Day 1||0.33|-0.25|0.7821
71694000|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|-0.77|||<|0.0001|TWO_SIDED|95.0|-1.14|-0.39|||Student's paired t-test|||Change from Baseline at Day 2||-0.39|-1.14|<.0001
71694001|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|-1.62|||<|0.0001|TWO_SIDED|95.0|-2.05|-1.19|||Student's paired t-test|||Change from Baseline at Day 3||-1.19|-2.05|<.0001
71694002|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|-2.29|||<|0.0001|TWO_SIDED|95.0|-2.73|-1.86|||Student's paired t-test|||Change from Baseline at Day 4||-1.86|-2.73|<.0001
71694003|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|-2.46|||<|0.0001|TWO_SIDED|95.0|-2.98|-1.94|||Student's paired t-test|||Change from Baseline at Day 5||-1.94|-2.98|<.0001
71694004|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|-2.64|||<|0.0001|TWO_SIDED|95.0|-3.36|-1.92|||Student's paired t-test|||Change from Baseline at Day 6||-1.92|-3.36|<.0001
71942205|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-3.5||||||95.0|-8.3|0.8||||||For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||0.8|-8.3|
71942206|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.7||||||95.0|-3.9|7.1||||||For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||7.1|-3.9|
71942207|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-2.3|1.7||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||1.7|-2.3|
71942208|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-1.0||||||95.0|-5.0|2.8||||||For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.8|-5.0|
71942209|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.7||||||95.0|-1.6|2.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.9|-1.6|
71942210|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
71942211|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-2.7||||||95.0|-7.3|1.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.||1.8|-7.3|
71942212|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated||1.7|-1.6|
71942213|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated||1.7|-1.6|
71942214|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.1||||||95.0|-4.3|4.1||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated||4.1|-4.3|
71942215|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.||1.7|-1.6|
71942216|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.5||||||95.0|-4.7|3.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.||3.7|-4.7|
71694005|NCT05556148|142902507|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.19|-2.21|||Student's paired t-test|||Change from Baseline at Day 7||-2.21|-4.19|<.0001
71694006|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|0.44||||0.0003|TWO_SIDED|95.0|0.21|0.68|||Student's paired t-test|||Change from Baseline at Day 1||0.68|0.21|0.0003
71694007|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|-0.07||||0.646|TWO_SIDED|95.0|-0.38|0.24|||Student's paired t-test|||Change from Baseline at Day 2||0.24|-0.38|0.6460
71694008|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|-0.59||||0.0021|TWO_SIDED|95.0|-0.95|-0.22|||Student's paired t-test|||Change from Baseline at Day 3||-0.22|-0.95|0.0021
71942217|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|-0.4||||||95.0|-3.0|2.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.||2.0|-3.0|
71694009|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|-0.83||||0.0002|TWO_SIDED|95.0|-1.25|-0.41|||Student's paired t-test|||Change from Baseline at Day 4||-0.41|-1.25|0.0002
71694010|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.73|||Student's paired t-test|||Change from Baseline at Day 5||-0.73|-1.68|<.0001
71694011|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|-1.36||||0.0003|TWO_SIDED|95.0|-2.04|-0.68|||Student's paired t-test|||Change from Baseline at Day 6||-0.68|-2.04|0.0003
71694012|NCT05556148|142902508|OTHER||Mean Difference (Final Values)|-2.13|||<|0.0001|TWO_SIDED|95.0|-2.95|-1.32|||Student's paired t-test|||Change from Baseline at Day 7||-1.32|-2.95|<.0001
71694013|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|0.2||||0.1074|TWO_SIDED|95.0|-0.04|0.45|||Student's paired t-test|||Change from Baseline at Day 1||0.45|-0.04|0.1074
71694014|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|-0.35||||0.0364|TWO_SIDED|95.0|-0.67|-0.02|||Student's paired t-test|||Change from Baseline at Day 2||-0.02|-0.67|0.0364
71694015|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|-1.29|||<|0.0001|TWO_SIDED|95.0|-1.68|-0.91|||Student's paired t-test|||Change from Baseline at Day 3||-0.91|-1.68|<.0001
71694016|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|-1.8|||<|0.0001|TWO_SIDED|95.0|-2.25|-1.36|||Student's paired t-test|||Change from Baseline at Day 4||-1.36|-2.25|<.0001
71694017|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.78|-1.69|||Student's paired t-test|||Change from Baseline at Day 5||-1.69|-2.78|<.0001
71694018|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|-2.08|||<|0.0001|TWO_SIDED|95.0|-2.7|-1.45|||Student's paired t-test|||Change from Baseline at Day 6||-1.45|-2.70|<.0001
71694019|NCT05556148|142902509|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.1|||Student's paired t-test|||Change from Baseline at Day 7||-2.10|-3.84|<.0001
71694020|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-1.88|||<|0.0001|TWO_SIDED|95.0|-2.33|-1.43|||Student's paired t-test|||Day 1||-1.43|-2.33|<.0001
71694021|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-2.45|||<|0.0001|TWO_SIDED|95.0|-2.9|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.90|<.0001
71694022|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-2.9|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.39|||Student's paired t-test|||Day 3||-2.39|-3.41|<.0001
71694023|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.82|-2.77|||Student's paired t-test|||Day 4||-2.77|-3.82|<.0001
71694024|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-2.95|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.37|||Student's paired t-test|||Day 5||-2.37|-3.53|<.0001
71694025|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-3.26|||<|0.0001|TWO_SIDED|95.0|-3.98|-2.53|||Student's paired t-test|||Day 6||-2.53|-3.98|<.0001
71694026|NCT05556148|142902510|OTHER||Mean Difference (Final Values)|-3.12|||<|0.0001|TWO_SIDED|95.0|-4.08|-2.16|||Student's paired t-test|||Day 7||-2.16|-4.08|<.0001
71694027|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-1.72|||<|0.0001|TWO_SIDED|95.0|-2.14|-1.31|||Student's paired t-test|||Day 1||-1.31|-2.14|<.0001
71694028|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-2.12|||<|0.0001|TWO_SIDED|95.0|-2.55|-1.7|||Student's paired t-test|||Day 2||-1.70|-2.55|<.0001
71694029|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-2.3|||<|0.0001|TWO_SIDED|95.0|-2.71|-1.9|||Student's paired t-test|||Day 3||-1.90|-2.71|<.0001
71694030|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.23|-2.29|||Student's paired t-test|||Day 4||-2.29|-3.23|<.0001
71694031|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-2.85|||<|0.0001|TWO_SIDED|95.0|-3.31|-2.39|||Student's paired t-test|||Day 5||-2.39|-3.31|<.0001
71694032|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-3.72|-2.64|||Student's paired t-test|||Day 6||-2.64|-3.72|<.0001
71694033|NCT05556148|142902511|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.9|-2.43|||Student's paired t-test|||Day 7||-2.43|-3.90|<.0001
71694034|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-1.98|||<|0.0001|TWO_SIDED|95.0|-2.39|-1.57|||Student's paired t-test|||Day 1||-1.57|-2.39|<.0001
71694035|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-2.24|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.81|||Student's paired t-test|||Day 2||-1.81|-2.66|<.0001
71694036|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.14|-2.32|||Student's paired t-test|||Day 3||-2.32|-3.14|<.0001
71694037|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-2.91|||<|0.0001|TWO_SIDED|95.0|-3.4|-2.43|||Student's paired t-test|||Day 4||-2.43|-3.40|<.0001
71694038|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-3.17|||<|0.0001|TWO_SIDED|95.0|-3.68|-2.66|||Student's paired t-test|||Day 5||-2.66|-3.68|<.0001
71694039|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-3.28|||<|0.0001|TWO_SIDED|95.0|-4.02|-2.54|||Student's paired t-test|||Day 6||-2.54|-4.02|<.0001
71694040|NCT05556148|142902512|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.24|-2.7|||Student's paired t-test|||Day 7||-2.70|-4.24|<.0001
71694041|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-1.96|||<|0.0001|TWO_SIDED|95.0|-2.37|-1.55|||Student's paired t-test|||Day 1||-1.55|-2.37|<.0001
71694042|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-2.42|||<|0.0001|TWO_SIDED|95.0|-2.83|-2.01|||Student's paired t-test|||Day 2||-2.01|-2.83|<.0001
71694043|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-2.97|||<|0.0001|TWO_SIDED|95.0|-3.41|-2.53|||Student's paired t-test|||Day 3||-2.53|-3.41|<.0001
71694044|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-3.34|||<|0.0001|TWO_SIDED|95.0|-3.81|-2.87|||Student's paired t-test|||Day 4||-2.87|-3.81|<.0001
71694045|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-3.36|||<|0.0001|TWO_SIDED|95.0|-3.84|-2.87|||Student's paired t-test|||Day 5||-2.87|-3.84|<.0001
71694046|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-3.23|||<|0.0001|TWO_SIDED|95.0|-3.91|-2.56|||Student's paired t-test|||Change from Baseline at Day 6||-2.56|-3.91|<.0001
71694047|NCT05556148|142902513|OTHER||Mean Difference (Final Values)|-3.7|||<|0.0001|TWO_SIDED|95.0|-4.48|-2.92|||Student's paired t-test|||Day 7||-2.92|-4.48|<.0001
71694048|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-1.76|||<|0.0001|TWO_SIDED|95.0|-2.17|-1.34|||Student's paired t-test|||Day 1||-1.34|-2.17|<.0001
71694049|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-2.09|||<|0.0001|TWO_SIDED|95.0|-2.51|-1.67|||Student's paired t-test|||Day 2||-1.67|-2.51|<.0001
71694050|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-2.41|||<|0.0001|TWO_SIDED|95.0|-2.86|-1.97|||Student's paired t-test|||Day 3||-1.97|-2.86|<.0001
71694051|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-2.74|||<|0.0001|TWO_SIDED|95.0|-3.22|-2.27|||Student's paired t-test|||Day 4||-2.27|-3.22|<.0001
71694052|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.3|-2.16|||Student's paired t-test|||Day 5||-2.16|-3.30|<.0001
71694053|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-2.87|||<|0.0001|TWO_SIDED|95.0|-3.56|-2.19|||Student's paired t-test|||Day 6||-2.19|-3.56|<.0001
71694054|NCT05556148|142902514|OTHER||Mean Difference (Final Values)|-3.2|||<|0.0001|TWO_SIDED|95.0|-4.01|-2.39|||Student's paired t-test|||Day 7||-2.39|-4.01|<.0001
71694055|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-1.93|||<|0.0001|TWO_SIDED|95.0|-2.35|-1.51|||Student's paired t-test|||Day 1||-1.51|-2.35|<.0001
71694056|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-2.6|||<|0.0001|TWO_SIDED|95.0|-3.0|-2.2|||Student's paired t-test|||Day 2||-2.20|-3.00|<.0001
71694057|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-2.65|||<|0.0001|TWO_SIDED|95.0|-3.09|-2.22|||Student's paired t-test|||Day 3||-2.22|-3.09|<.0001
71694058|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-3.07|||<|0.0001|TWO_SIDED|95.0|-3.53|-2.62|||Student's paired t-test|||Day 4||-2.62|-3.53|<.0001
71694059|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-3.25|||<|0.0001|TWO_SIDED|95.0|-3.76|-2.75|||Student's paired t-test|||Day 5||-2.75|-3.76|<.0001
71694060|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-3.41|||<|0.0001|TWO_SIDED|95.0|-4.04|-2.78|||Student's paired t-test|||Day 6||-2.78|-4.04|<.0001
71694061|NCT05556148|142902515|OTHER||Mean Difference (Final Values)|-3.47|||<|0.0001|TWO_SIDED|95.0|-4.3|-2.64|||Student's paired t-test|||Day 7||-2.64|-4.30|<.0001
71694062|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-2.07|||<|0.0001|TWO_SIDED|95.0|-2.49|-1.66|||Student's paired t-test|||Day 1||-1.66|-2.49|<.0001
71694063|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-2.76|||<|0.0001|TWO_SIDED|95.0|-3.2|-2.33|||Student's paired t-test|||Day 2||-2.33|-3.20|<.0001
71694064|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-3.21|||<|0.0001|TWO_SIDED|95.0|-3.63|-2.78|||Student's paired t-test|||Day 3||-2.78|-3.63|<.0001
71942218|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|1.4||||||95.0|-0.8|4.2||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated||4.2|-0.8|
71694065|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-3.49|||<|0.0001|TWO_SIDED|95.0|-3.98|-3.0|||Student's paired t-test|||Day 4||-3.00|-3.98|<.0001
71694066|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-3.83|||<|0.0001|TWO_SIDED|95.0|-4.33|-3.33|||Student's paired t-test|||Day 5||-3.33|-4.33|<.0001
71694067|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-4.05|||<|0.0001|TWO_SIDED|95.0|-4.65|-3.46|||Student's paired t-test|||Day 6||-3.46|-4.65|<.0001
71694068|NCT05556148|142902516|OTHER||Mean Difference (Final Values)|-4.13|||<|0.0001|TWO_SIDED|95.0|-4.81|-3.46|||Student's paired t-test|||Day 7||-3.46|-4.81|<.0001
71694069|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-2.21|||<|0.0001|TWO_SIDED|95.0|-2.66|-1.77|||Student's paired t-test|||Day 1||-1.77|-2.66|<.0001
71694070|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-2.73|||<|0.0001|TWO_SIDED|95.0|-3.15|-2.31|||Student's paired t-test|||Day 2||-2.31|-3.15|<.0001
71694071|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-3.16|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.73|||Student's paired t-test|||Day 3||-2.73|-3.60|<.0001
71694072|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-3.52|||<|0.0001|TWO_SIDED|95.0|-4.0|-3.05|||Student's paired t-test|||Day 4||-3.05|-4.00|<.0001
71694073|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-3.73|||<|0.0001|TWO_SIDED|95.0|-4.19|-3.27|||Student's paired t-test|||Day 5||-3.27|-4.19|<.0001
71694074|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.55|-3.45|||Student's paired t-test|||Day 6||-3.45|-4.55|<.0001
71694075|NCT05556148|142902517|OTHER||Mean Difference (Final Values)|-4.07|||<|0.0001|TWO_SIDED|95.0|-4.74|-3.39|||Student's paired t-test|||Day 7||-3.39|-4.74|<.0001
71694076|NCT00458003|142902527|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||||||.38
71694077|NCT00458003|142902528|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||||||.10
71694078|NCT01039467|142902549|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71694079|NCT01039467|142902550|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71694080|NCT01039467|142902551|SUPERIORITY_OR_OTHER_LEGACY|||||||0.833||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.833
71694081|NCT01039467|142902552|SUPERIORITY_OR_OTHER_LEGACY|||||||0.265||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.265
71694082|NCT01039467|142902553|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71694083|NCT01039467|142902554|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71694084|NCT01039467|142902555|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0008||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0008
71694085|NCT01039467|142902556|SUPERIORITY_OR_OTHER_LEGACY|||||||0.053||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.053
71694086|NCT01039467|142902557|SUPERIORITY_OR_OTHER_LEGACY|||||||0.493||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.493
71694087|NCT01746862|142902561|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|3.47|||<|0.0001|TWO_SIDED|95.0|2.17|4.78|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with baseline age and baseline height as the covariates.||||4.78|2.17|<0.0001
71694088|NCT03519009|142902617|SUPERIORITY||Odds Ratio (OR)|3.4|||<|0.001|TWO_SIDED|95.0|1.8|6.3|||longitudinal logistic regression|||||6.3|1.8|<0.001
71694089|NCT03519009|142902618|SUPERIORITY||Odds Ratio (OR)|2.6|||<|0.001|TWO_SIDED|95.0|1.5|4.4|||longitudinal logistic regression|||||4.4|1.5|<0.001
71694090|NCT06058390|142902619|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.91|1.14|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.14|0.91|
71694091|NCT06058390|142902620|OTHER||Geometric mean ratio|1.05|||||TWO_SIDED|90.0|0.96|1.15|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.15|0.96|
71694092|NCT06058390|142902621|OTHER||Geometric mean ratio|1.02|||||TWO_SIDED|90.0|0.88|1.18|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.18|0.88|
71942219|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|4.0||||||95.0|-0.4|8.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.||8.7|-0.4|
71942220|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.||2.0|-2.3|
71942221|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated||2.0|-2.3|
71942222|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|3.8||||||95.0|-1.7|10.9||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.||10.9|-1.7|
71942223|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
71942224|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
71942225|NCT00366899|143405584|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was \> -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.||2.1|-2.4|
71942226|NCT00366899|143405585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.87|1.1||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.10|0.87|
71942227|NCT00366899|143405585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.92|1.16||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.16|0.92|
71942228|NCT00366899|143405585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.87|1.17||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.17|0.87|
71942229|NCT00366899|143405585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.89|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated||1.15|0.89|
71942230|NCT00366899|143405585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.83|1.07||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.83|
71942231|NCT00366899|143405585|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.07||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.82|
71942232|NCT00366899|143405588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.96||||||95.0|0.72|1.27||||||For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated||1.27|0.72|
71942233|NCT00366899|143405588|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.54|0.96||||||For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated||0.96|0.54|
71942234|NCT00366899|143405589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.75|1.3||||||or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.75|
71942235|NCT00366899|143405589|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.81|1.3||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated||1.30|0.81|
71942236|NCT00366899|143405590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.65|0.94||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.94|0.65|
71942237|NCT00366899|143405590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.67|1.08||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.67|
71942238|NCT00366899|143405590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.75||||||95.0|0.63|0.89||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated||0.89|0.63|
71942239|NCT00366899|143405590|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|1.25||||||95.0|0.88|1.79||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated||1.79|0.88|
71942240|NCT00366899|143405591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.7|1.08||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||1.08|0.70|
71942241|NCT00366899|143405591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.74|1.22||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.22|0.74|
71942242|NCT00366899|143405591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.68|1.13||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||1.13|0.68|
71942243|NCT00366899|143405591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.69||||||95.0|0.55|0.86||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated||0.86|0.55|
71942244|NCT00366899|143405591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.68|1.07||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated||1.07|0.68|
71942245|NCT00366899|143405591|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was \>0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.51|0.83||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated||0.83|0.51|
71942246|NCT00414466|143405598|SUPERIORITY_OR_OTHER|||||||0.802||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.802
71942247|NCT00414466|143405598|SUPERIORITY_OR_OTHER|||||||0.874||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.874
71942248|NCT00414466|143405598|SUPERIORITY_OR_OTHER|||||||0.899||95.0||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.||||0.899
71942249|NCT00414466|143405599|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
71942250|NCT00414466|143405599|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
71942251|NCT00414466|143405599|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact|||||||1.000
71942252|NCT00414466|143405600|SUPERIORITY_OR_OTHER|||||||0.083||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.083
71942253|NCT00414466|143405600|SUPERIORITY_OR_OTHER|||||||1||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||1.000
71942254|NCT00414466|143405600|SUPERIORITY_OR_OTHER|||||||0.352||95.0||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact|||||||0.352
71694093|NCT06058390|142902622|OTHER||Geometric mean ratio|0.98|||||TWO_SIDED|90.0|0.88|1.09|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.09|0.88|
71694094|NCT06058390|142902623|OTHER||Geometric mean ratio|0.99|||||TWO_SIDED|90.0|0.87|1.13|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.13|0.87|
71694095|NCT06058390|142902624|OTHER||Geometric mean ratio|0.97|||||TWO_SIDED|90.0|0.87|1.08|||||Geometric mean is adjusted for covariates: randomized groups (Arms 1 and 2 of this endpoint), injection site (arm, thigh and abdomen) as categorical covariates and log transformed Baseline weight as continuous covariate.|Analysis was performed on the natural logarithms using a fixed-effects model.||1.08|0.87|
71942255|NCT05628675|143405626|OTHER||Effect size (Hedge's g)|0.32|||||TWO_SIDED|95.0|-0.33|0.96||||||Effect size calculation from Time 1 to Time 2 on MAAS||0.96|-0.33|
71942256|NCT05628675|143405626|OTHER||Effect size (Hedge's g)|0.72|||||TWO_SIDED|95.0|0.02|1.42||||||Effect size calculation from Time 1 to Time 3 on MAAS||1.42|0.02|
71942257|NCT05628675|143405627|OTHER||Effect size (Hedge's g)|0.36|||||TWO_SIDED|95.0|-0.29|1.01||||||Effect size calculation from Time 1 to Time 2 on P-PRFQ||1.01|-0.29|
71942258|NCT05628675|143405627|OTHER||Effect size (Hedge's g)|0.49|||||TWO_SIDED|95.0|-0.2|1.17||||||Effect size calculation from Time 1 to Time 3 on P-PRFQ||1.17|-0.20|
71942259|NCT05628675|143405628|OTHER||Effect size (Hedge's g)|1.48|||||TWO_SIDED|95.0|0.75|2.21||||||Effect size calculation from Time 1 to Time 2 on EPDS||2.21|0.75|
71694096|NCT03361306|142902625|SUPERIORITY|Assuming the true VGPR+ rate is 40% under the null hypothesis, then this design will provide 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. For the originally planned enrollment of 40 subjects, if at least 21 subjects achieved VGPR or better to induction, the null hypothesis would be rejected.|Response Rate|0.467||||0.39|TWO_SIDED|95.0|0.213|0.734||This p-value is only based on partial enrollment on the study. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|||0.734|0.213|0.390
71694097|NCT02131064|142902633|SUPERIORITY||Difference in tpCR rate|-11.71||||0.0126|TWO_SIDED|95.0|-20.95|-2.48||Threshold for significance at 5%|Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in tPCR rates between treatment arms was calculated using normal approximation.||-2.48|-20.95|0.0126
71694098|NCT02131064|142902634|SUPERIORITY||Hazard Ratio (HR)|1.21||||0.7557|TWO_SIDED|95.0|0.37|3.96|||Cochran-Mantel-Haenszel Chi-Square Test|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||||3.96|0.37|0.7557
71694099|NCT02131064|142902635|SUPERIORITY||Difference in BCS rate|-10.84||||0.0228|TWO_SIDED|95.0|-20.21|-1.47|||Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in BCS rate between treatment arms was calculated using normal approximation.||-1.47|-20.21|0.0228
71694100|NCT02131064|142902636|SUPERIORITY||Hazard Ratio (HR)|2.61||||0.0027|TWO_SIDED|95.0|1.36|4.98|||Log Rank|The Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||||4.98|1.36|0.0027
71694101|NCT02131064|142902637|SUPERIORITY||Hazard Ratio (HR)|1.11|||||TWO_SIDED|95.0|0.52|2.4||||||||2.40|0.52|
71694102|NCT02131064|142902640|SUPERIORITY||Difference in Deterioration|-24.58|||||TWO_SIDED|95.0|-33.98|-15.19||||||95% CI for the difference in clinically meaningful deterioration in GHS/QoL score between treatment arms was calculated using normal approximation.||-15.19|-33.98|
71694103|NCT02131064|142902641|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.0001|TWO_SIDED|95.0|0.46|0.78|||Log Rank|Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||Stratified cox proportional hazards regression model was used to estimate Hazard Ratio and CI. Stratification by hormonal receptor status and clinical stage at presentation (stratification factors).||0.78|0.46|0.0001
71694104|NCT02131064|142902652|SUPERIORITY||Difference in Deterioration|-16.63|||||TWO_SIDED|95.0|-26.32|-6.94||||||This is the statistical analysis for cognitive functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-6.94|-26.32|
71694105|NCT02131064|142902652|SUPERIORITY||Difference in Deterioration|-32.54|||||TWO_SIDED|95.0|-41.74|-23.34||||||This is the statistical analysis for physical functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-23.34|-41.74|
71942260|NCT05628675|143405628|OTHER||Effect size (Hedge's g)|2.08|||||TWO_SIDED|95.0|1.28|2.88||||||Effect size calculation from Time 1 to Time 3 on EPDS||2.88|1.28|
71694106|NCT02131064|142902652|SUPERIORITY||Difference in Deterioration|-28.88|||||TWO_SIDED|95.0|-37.95|-19.8||||||This is the statistical analysis for role functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.||-19.80|-37.95|
71694107|NCT00810069|142902666|SUPERIORITY_OR_OTHER|||||||0.213|TWO_SIDED|95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier Analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Kaplan-Meier Estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.213
71694108|NCT00810069|142902667|SUPERIORITY_OR_OTHER||survival rate difference|0.02||||0.653|TWO_SIDED|95.0|-0.06|0.1||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.10|-0.06|0.653
71694109|NCT00810069|142902668|SUPERIORITY_OR_OTHER|||||||0.947||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Analysis of early intervention strategy versus delayed intervention strategy||||0.947
71694110|NCT00810069|142902669|SUPERIORITY_OR_OTHER|||||||0.597||95.0||||P-value is for early intervention versus delayed intervention strategies.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Analysis of early intervention strategy versus delayed intervention strategy||||0.597
71694111|NCT00810069|142902670|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.624|TWO_SIDED|95.0|-0.22|0.13||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||0.13|-0.22|0.624
71761226|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.5|-0.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.||-0.6|-1.5|<0.0001
71942261|NCT01475838|143405645|NON_INFERIORITY_OR_EQUIVALENCE|The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA \< 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.|Difference in proportions|6.7||||0.025|TWO_SIDED|95.0|0.4|13.7|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.|||13.7|0.4|0.025
71694112|NCT00810069|142902670|SUPERIORITY_OR_OTHER||LS Mean|-0.11|STANDARD_ERROR_OF_MEAN|0.09||0.208|TWO_SIDED|95.0|-0.29|0.06||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed Models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.06|-0.29|0.208
71694113|NCT00810069|142902670|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.09||0.044|TWO_SIDED|95.0|-0.37|0.0||P-value for Week 10: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||-0.00|-0.37|0.044
71694114|NCT00810069|142902670|SUPERIORITY_OR_OTHER||LS Mean|-0.16|STANDARD_ERROR_OF_MEAN|0.1||0.086|TWO_SIDED|95.0|-0.35|0.02||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interactions, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.02|-0.35|0.086
71694115|NCT00810069|142902670|SUPERIORITY_OR_OTHER||LS Mean|-0.13|STANDARD_ERROR_OF_MEAN|0.1||0.181|TWO_SIDED|95.0|-0.33|0.06||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.06|-0.33|0.181
71694116|NCT00810069|142902670|SUPERIORITY_OR_OTHER||LS Mean|0.0|STANDARD_ERROR_OF_MEAN|0.1||0.994|TWO_SIDED|95.0|-0.2|0.2||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.20|-0.20|0.994
71694117|NCT00810069|142902671|SUPERIORITY_OR_OTHER||LS Mean|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6||-0.25|-0.98|0.001
71694118|NCT00810069|142902671|SUPERIORITY_OR_OTHER||LS Mean|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.01|TWO_SIDED|95.0|-0.87|-0.12||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.12|-0.87|0.010
71694119|NCT00810069|142902671|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.2||0.445|TWO_SIDED|95.0|-0.55|0.24||P-value for Week 10: analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10||0.24|-0.55|0.445
71694120|NCT00810069|142902671|SUPERIORITY_OR_OTHER||LS Mean|-0.29|STANDARD_ERROR_OF_MEAN|0.21||0.169|TWO_SIDED|95.0|-0.71|0.12||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.12|-0.71|0.169
71694121|NCT00810069|142902671|SUPERIORITY_OR_OTHER||LS Mean|-0.19|STANDARD_ERROR_OF_MEAN|0.23||0.393|TWO_SIDED|95.0|-0.63|0.25||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14||0.25|-0.63|0.393
71694122|NCT00810069|142902671|SUPERIORITY_OR_OTHER||LS Mean|-0.15|STANDARD_ERROR_OF_MEAN|0.23||0.51|TWO_SIDED|95.0|-0.61|0.3||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline scores and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.30|-0.61|0.510
71694123|NCT00810069|142902672|SUPERIORITY_OR_OTHER||LS Mean|0.14|STANDARD_ERROR_OF_MEAN|0.17||0.401|TWO_SIDED|95.0|-0.19|0.47||P-value for Week 8: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||0.47|-0.19|0.401
71694124|NCT00810069|142902672|SUPERIORITY_OR_OTHER||LS Mean|0.09|STANDARD_ERROR_OF_MEAN|0.19||0.618|TWO_SIDED|95.0|-0.27|0.46||P-value for Week 12: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.46|-0.27|0.618
71694125|NCT00810069|142902672|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.2||0.856|TWO_SIDED|95.0|-0.43|0.36||P-value for Week 16: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.36|-0.43|0.856
71942262|NCT00048568|143405649|SUPERIORITY_OR_OTHER||Estimated Difference|28.2|||<|0.001|TWO_SIDED|95.0|19.8|36.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.|The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.||36.7|19.8|<0.001
71942263|NCT00048568|143405650|SUPERIORITY_OR_OTHER||Estimated Difference|24.4|||<|0.001|TWO_SIDED|95.0|15.9|32.9||Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.|Chi-squared, Corrected|This model includes treatment as the main factor and baseline value as a covariate.|Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.|||32.9|15.9|<0.001
71942264|NCT00048568|143405651|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||Nonparametric ANCOVA|The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.||||||0.029
71942265|NCT00048568|143405655|SUPERIORITY_OR_OTHER||Estimated Difference|33.4|||<|0.001|TWO_SIDED|95.0|25.1|41.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.|||41.7|25.1|<0.001
71694126|NCT00810069|142902673|SUPERIORITY_OR_OTHER||LS Mean|-0.05|STANDARD_ERROR_OF_MEAN|0.02||0.021|TWO_SIDED|95.0|-0.1|-0.01||P-value for Week 8: Analysis of early versus delayed intervention LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||-0.01|-0.10|0.021
71694127|NCT00810069|142902673|SUPERIORITY_OR_OTHER||LS Mean|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.071|TWO_SIDED|95.0|-0.09|0.0||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.00|-0.09|0.071
71694128|NCT00810069|142902673|SUPERIORITY_OR_OTHER||LS Mean|0.01|STANDARD_ERROR_OF_MEAN|0.03||0.792|TWO_SIDED|95.0|-0.05|0.06||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||0.06|-0.05|0.792
71694129|NCT00810069|142902674|SUPERIORITY_OR_OTHER||LS Mean|-0.37|STANDARD_ERROR_OF_MEAN|0.7||0.597|TWO_SIDED|95.0|-1.74|1.0||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8||1.00|-1.74|0.597
71694130|NCT00810069|142902674|SUPERIORITY_OR_OTHER||LS Mean|-0.68|STANDARD_ERROR_OF_MEAN|0.74||0.36|TWO_SIDED|95.0|-2.13|0.78||P-value for Week 12: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12||0.78|-2.13|0.360
71694131|NCT00810069|142902674|SUPERIORITY_OR_OTHER||LS Mean|0.06|STANDARD_ERROR_OF_MEAN|0.81||0.937|TWO_SIDED|95.0|-1.52|1.65||P-value for Week 16: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16||1.65|-1.52|0.937
71694132|NCT00810069|142902675|SUPERIORITY_OR_OTHER|||||||0.075||95.0||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Kaplan-Meier estimates (weeks): analysis of early intervention versus delayed intervention strategies||||0.075
71694133|NCT00810069|142902676|SUPERIORITY_OR_OTHER||Survival rate difference|-0.07||||0.116|TWO_SIDED|95.0|-0.16|0.02||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan-Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies||0.02|-0.16|0.116
71694134|NCT03675360|142902684|SUPERIORITY||Mean Difference (Net)|-0.23|||<|0.05|TWO_SIDED|95.0|-0.32|-0.14|||linear mixed effects model|||||-0.14|-0.32|<0.05
71694135|NCT03675360|142902685|SUPERIORITY||Mean Difference (Net)|-10.3|||<|0.05|TWO_SIDED|95.0|-15.6|-4.9|||linear mixed effects model|||||-4.9|-15.6|<0.05
71694136|NCT03675360|142902686|SUPERIORITY||Mean Difference (Net)|-3.2|||<|0.05|TWO_SIDED|95.0|-7.3|0.9|||linear mixed effects model|||||0.9|-7.3|<0.05
71694137|NCT03675360|142902687|SUPERIORITY||Median Difference (Final Values)|-0.13|||<|0.05|TWO_SIDED|95.0|-0.31|0.05|||linear mixed effects model|||||0.05|-0.31|<0.05
71694138|NCT03675360|142902688|SUPERIORITY||Mean Difference (Net)|-5.9|||<|0.05|TWO_SIDED|95.0|-7.4|-4.4|||linear mixed effects model|||||-4.4|-7.4|<0.05
71694139|NCT03675360|142902689|SUPERIORITY||Mean Difference (Net)|-6.2|||<|0.05|TWO_SIDED|95.0|-10.5|-2.0|||linear mixed effects model|||||-2.0|-10.5|<0.05
71694140|NCT03675360|142902690|SUPERIORITY||Mean Difference (Net)|-2.4|||<|0.05|TWO_SIDED|95.0|-3.7|-1.1|||linear mixed effects model|||||-1.1|-3.7|<0.05
71694141|NCT03675360|142902691|SUPERIORITY||Mean Difference (Net)|-2.6|||<|0.05|TWO_SIDED|95.0|-5.2|0.0|||linear mixed effects model|||||0|-5.2|<0.05
71694142|NCT03675360|142902692|SUPERIORITY||Mean Difference (Net)|-4.7|||<|0.05|TWO_SIDED|95.0|-6.7|-2.6|||linear mixed effects model|||||-2.6|-6.7|<0.05
71694143|NCT03675360|142902693|SUPERIORITY||Mean Difference (Net)|-0.8|||<|0.05|TWO_SIDED|95.0|-1.8|0.3|||linear mixed effects model|||||0.3|-1.8|<0.05
71942266|NCT00048568|143405657|SUPERIORITY_OR_OTHER||Estimated Difference|23.0|||<|0.001|TWO_SIDED|95.0|15.0|31.1|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.|||31.1|15.0|<0.001
71942267|NCT00048568|143405658|SUPERIORITY_OR_OTHER||Estimated Difference|30.1|||<|0.001|TWO_SIDED|95.0|21.8|38.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.|||38.5|21.8|<0.001
71694144|NCT04767373|142902706|OTHER||Efficacy estimate|60.4|||<|0.001|TWO_SIDED|95.0|44.1|71.9|||Exact method|One-sided p-value was estimated using an exact method.|A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- Relative Risk \[RR\]) \& 95% confidence interval (CI). The model included region, gestational age, and age at randomization as covariates.|||71.9|44.1|<0.001
71942268|NCT00048568|143405660|SUPERIORITY_OR_OTHER||Estimated Difference|13.3|||<|0.001|TWO_SIDED|95.0|7.0|19.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.|||19.5|7.0|<0.001
71942269|NCT00048568|143405661|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.7|||<|0.001|TWO_SIDED|95.0|15.6|29.8|||Chi-squared, Corrected|||||29.8|15.6|<0.001
71942270|NCT00048568|143405663|SUPERIORITY_OR_OTHER||Estimated Difference|12.3|||<|0.001|TWO_SIDED|95.0|7.3|17.2|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.|||17.2|7.3|<0.001
71942271|NCT00048568|143405664|SUPERIORITY_OR_OTHER||Estimated Difference on Day 169|-1.15|||<|0.001|TWO_SIDED|95.0|-1.38|-0.91|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 169.|||-0.91|-1.38|<0.001
71942272|NCT00048568|143405664|SUPERIORITY_OR_OTHER||Estimated Difference on Day 365|-1.39|||<|0.001|TWO_SIDED|95.0|-1.63|-1.16|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 365.|||-1.16|-1.63|<0.001
71942273|NCT00048568|143405668|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 169|4.06|||<|0.001|TWO_SIDED|95.0|2.64|5.57|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.57|2.64|<0.001
71942274|NCT00048568|143405668|SUPERIORITY_OR_OTHER||Adjusted Mean Difference at Day 365|4.15|||<|0.001|TWO_SIDED|95.0|2.69|5.62|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||5.62|2.69|<0.001
71694145|NCT04767373|142902707|OTHER||Estimated Percentage Difference|-0.5|||||TWO_SIDED|95.0|-2.6|1.5|||||Estimated percentage difference beteween Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.5|-2.6|
71694146|NCT04767373|142902708|OTHER||Estimated Percentage Difference|-0.6|||||TWO_SIDED|95.0|-1.4|0.0|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||-0.0|-1.4|
71694147|NCT04767373|142902709|OTHER||Estimated Percentage Difference|-1.8|||||TWO_SIDED|95.0|-5.0|1.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||1.2|-5.0|
71694148|NCT04767373|142902710|OTHER||Estimated Percentage Difference|0.0|||||TWO_SIDED|95.0|-0.3|0.2|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.2|-0.3|
71694149|NCT04767373|142902711|OTHER||Estimated Percentage Difference|0.1|||||TWO_SIDED|95.0|-0.4|0.5|||||Estimated percentage difference between Clesrovimab 105 mg arm and placebo arm and associated 95% CI were calculated based on the Miettinen \& Nurminen method.|||0.5|-0.4|
71942275|NCT00048568|143405669|SUPERIORITY_OR_OTHER||Estimated Difference|5.7||||0.002|TWO_SIDED|95.0|2.4|9.0|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.|||9.0|2.4|0.002
71942276|NCT03831048|143405795|NON_INFERIORITY|The primary analysis of this endpoint will be performed using a linear probability model, with the following terms in the model: (1) treatment; and (2) the known donor and recipient risk factors listed above. Variables that make the model fail to converge will be dropped from the model. The test will be conducted at the one-sided 0.05 level of significance.|Mean Difference (Final Values)|-0.032|||<|0.0001|TWO_SIDED|90.0|-0.098|0.034||No multiple comparison adjustment.|Regression, Linear|||"The null and alternative hypotheses for the primary endpoint are as follows:~H0: pSOC - pDCD ≥ 0.20 vs. H1: pSOC - pDCD \< 0.20 where pDCD and pSOC represent the true survival proportions at the six months follow-up visit for DCD and SOC heart transplant patients, respectively."||0.034|-0.098|<0.0001
71942277|NCT03831048|143405796|OTHER|No hypothesis test.||||||||||||||||No null hypothesis test.|No statistical hypothesis testing. This endpoint will be summarized for the OCS Heart Population using counts and percentages and an exact (Clopper-Pearson) 95% confidence interval for the true percentage based on the binomial distribution. It will also be summarized for the modified OCS Heart Population, defined as the number of DCD hearts that were successfully transplanted after preservation and assessment on the OCS divided by the total number of DCD donor hearts that were instrumented on the OCS.|||
71942278|NCT03227445|143405858|SUPERIORITY||Odds Ratio (OR)|6.88|||<|0.001|TWO_SIDED|95.0|1.97|54.28|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||"There are three intercurrent events identified which could impact upon the estimand of interest:~* The participant could withdraw from randomised study device sequence and therefore withdraw from the study~* The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol.~* The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol.~Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events"|54.28|1.97|<0.001
71694150|NCT04767373|142902714|OTHER||Efficacy estimate|84.2|||<|0.001|TWO_SIDED|95.0|66.6|92.6||One-sided p-value was estimated using an exact method.|Exact method||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||92.6|66.6|<0.001
71694151|NCT04767373|142902715|OTHER||Efficacy estimate|59.5|||||TWO_SIDED|95.0|43.3|71.1|||||A modified Poisson regression with robust variance method was used to generate efficacy estimate (1- RR) \& 95% CI. The model included region, gestational age, and age at randomization as covariates.|||71.1|43.3|
71694152|NCT00593918|142902720|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.04
71694153|NCT00593918|142902721|SUPERIORITY_OR_OTHER|||||||0.14||95.0||||Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.||||||0.14
71942279|NCT03227445|143405860|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
71942280|NCT03227445|143405865|SUPERIORITY||Odds Ratio (OR)|8.85|||<|0.001|TWO_SIDED|95.0|3.45||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||||3.45|<0.001
71942281|NCT03227445|143405866|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Estimand: Composite)||||||<0.001
71942282|NCT03227445|143405867|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)||||||<0.001
71942283|NCT03227445|143405868|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Composite Estimand)||||||<0.001
71942284|NCT03227445|143405869|SUPERIORITY||Odds Ratio (OR)|6.06|||<|0.001|TWO_SIDED|95.0|2.08|24.55|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.|||24.55|2.08|<0.001
71942285|NCT01880073|143405870|OTHER||Proportion|0.875|||||TWO_SIDED|95.0|0.74|1.0||||||||1.00|0.74|
71942286|NCT01880073|143405871|OTHER||Proportion|0.125|||||TWO_SIDED|95.0|0.0|0.26||||||||0.26|0.00|
71942287|NCT00755196|143405874|SUPERIORITY_OR_OTHER|||||||0.23|||||||2-sided sign test|||||||0.23
71694154|NCT01569126|142902758|SUPERIORITY_OR_OTHER||Slope|0.026||||||95.0|||||||The correlation of time-matched change from baseline QTcF interval (dependent variable) to the time-matched plasma concentration of total fluoxetine and norfluoxetine (covariate) and participant (random effect).|||||
71694155|NCT03421379|142902759|NON_INFERIORITY|The pre-defined non-inferiority margin is (10%)|Treatment Difference Wald's Method|0.0|||||TWO_SIDED|95.0|-1.47|1.47||||||||1.47|-1.47|
71694156|NCT04195061|142902790|SUPERIORITY|||||||0.303|||||||t-test, 2 sided|||||||0.303
71694157|NCT04195061|142902791|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71942288|NCT01703832|143405876|SUPERIORITY_OR_OTHER|||||||0.1233||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.1233
71942289|NCT01703832|143405877|SUPERIORITY_OR_OTHER|||||||0.5153||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.||||0.5153
71942290|NCT00771537|143405897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.69|STANDARD_ERROR_OF_MEAN|0.17||0.05|TWO_SIDED|95.0|0.5|0.96|||Regression, Logistic||Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).|||.96|.50|0.05
71942291|NCT00771537|143405897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.75|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|0.54|1.04|||Regression, Logistic||Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).|||1.04|.54|.10
71942292|NCT00771537|143405897|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92|STANDARD_ERROR_OF_MEAN|0.176||0.63|TWO_SIDED|95.0|0.65|1.3|||Regression, Logistic||Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)|||1.30|.65|.63
71694158|NCT04195061|142902792|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71694159|NCT00196105|142902798|SUPERIORITY_OR_OTHER|||||||0.057||95.0|||||Log Rank|||||||.057
71942293|NCT00771537|143405898|SUPERIORITY_OR_OTHER||Marginal Means|2.49|STANDARD_ERROR_OF_MEAN|0.037|<|0.6|TWO_SIDED|95.0|2.42|2.56|||ANOVA|Degrees of freedom = (1,978)|There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-way Analysis of Variance||2.56|2.42|<.60
71942294|NCT00771537|143405898|SUPERIORITY_OR_OTHER||Marginal Means|2.51|STANDARD_ERROR_OF_MEAN|0.036|<|0.25|TWO_SIDED|95.0|2.44|2.58|||ANOVA|degrees of freedom = (1,1028)|There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.58|2.44|<.25
71694160|NCT00196105|142902799|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Chi-squared|||||||.04
71694161|NCT00196105|142902799|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Death is censored for Kaplan-Meier analysis.|Log Rank|||||||.007
71694162|NCT00196105|142902799|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Chi-squared|||||||.69
71942295|NCT00771537|143405898|SUPERIORITY_OR_OTHER||Marginal Means|2.47|STANDARD_ERROR_OF_MEAN|0.036|<|0.91|TWO_SIDED|95.0|2.4|2.54|||ANOVA||There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance||2.54|2.40|<.91
71942296|NCT00243932|143405899|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14||95.0|||||futility (non-superiority)|||Null hypothesis: 2,700mg CoQ10 is at least 20% superior to placebo.||||0.14
71694163|NCT00196105|142902799|SUPERIORITY_OR_OTHER|||||||0.02||95.0||||P-value is adjusted for multiple comparisons.|Chi-squared|||6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined||||.02
71694164|NCT00196105|142902800|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||.16
71694165|NCT00196105|142902802|SUPERIORITY_OR_OTHER|||||||0.32||95.0|||||Log Rank|||||||.32
71942297|NCT00437658|143405914|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-0.3||||0.963|TWO_SIDED|95.0|-13.4|12.7|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||12.7|-13.4|0.9630
71942298|NCT00437658|143405914|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-12.4||||0.101|TWO_SIDED|95.0|-26.7|1.8|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC|||1.8|-26.7|0.1010
71694166|NCT00196105|142902802|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||Kruskal-Wallis|||||||.69
71694167|NCT04863872|142902803|OTHER|Difference|Risk Ratio (RR)|0.72||||0.27|TWO_SIDED|95.0|0.39|1.3|||Poisson regression|Poisson regression with binary primary outcome, estimated using Generalized Estimating Equations (GEE) and robust variance estimation.||||1.30|0.39|0.27
71694168|NCT02864407|142902822|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
71694169|NCT02864407|142902823|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71694170|NCT02864407|142902824|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
71694171|NCT02864407|142902825|OTHER||||||<|0.0001||||||p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.|Paired t-test|||||||<0.0001
71694172|NCT02864407|142902826|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
71694173|NCT02864407|142902827|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
71694174|NCT02864407|142902828|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 24 (±2weeks) versus Baseline.||||||<0.0001
71694175|NCT02864407|142902829|OTHER||||||<|0.0001|||||||Paired t-test|p-value for difference of Follow-up Week 52 (±2weeks) versus Baseline.||||||<0.0001
71694176|NCT02864407|142902830|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71694177|NCT02864407|142902831|OTHER||||||<|0.0001||||||p-value for difference of 52±2 weeks versus Baseline.|Paired t-test|||||||<0.0001
71694178|NCT02864407|142902832|OTHER||||||<|0.0001||||||p-value for difference of Week 24 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71694179|NCT02864407|142902833|OTHER||||||<|0.0001||||||p-value for difference of Week 52 (±2 weeks) versus Baseline.|Paired t-test|||||||<0.0001
71942299|NCT00437658|143405915|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|9.5||||0.2048|TWO_SIDED|95.0|-5.2|24.2|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||24.2|-5.2|0.2048
71694180|NCT02849080|142902853|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Odds Ratio (OR)|4.4|||<|0.0001|TWO_SIDED|95.0|2.89|6.7||Unadjusted two-sided p-value for test of no difference from 1.|Pattern mixture model||Oral Semaglutide flex / Sitagliptin 100 mg.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||6.70|2.89|<0.0001
71694181|NCT02849080|142902853|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Odds Ratio (OR)|5.54|||<|0.0001|TWO_SIDED|95.0|3.54|8.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Logistic||Oral Semaglutide flex / Sitagliptin 100 mg|The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||8.68|3.54|<0.0001
71694182|NCT02849080|142902854|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.9|||<|0.0001|TWO_SIDED|95.0|-2.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixture model||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.||-1.2|-2.6|<0.0001
71694183|NCT02849080|142902854|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.2|||<|0.0001|TWO_SIDED|95.0|-2.9|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.5|-2.9|<0.0001
71694184|NCT02849080|142902871|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.18|||<|0.0001|TWO_SIDED|95.0|0.09|0.39||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.39|0.09|<0.0001
71942300|NCT00437658|143405915|NON_INFERIORITY|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|0.5||||0.9544|TWO_SIDED|95.0|-15.1|16.0|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC|||16.0|-15.1|0.9544
71694185|NCT02849080|142902872|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.58||||0.0175|TWO_SIDED|95.0|0.37|0.91||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||0.91|0.37|0.0175
71694186|NCT02849080|142902891|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77||||0.4381|TWO_SIDED|95.0|0.39|1.5||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.||1.50|0.39|0.4381
71694187|NCT02849080|142902892|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.47||||0.079|TWO_SIDED|95.0|0.2|1.09||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||1.09|0.20|0.0790
71694188|NCT00791219|142902925|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|6.47|||||ONE_SIDED|95.0|-1.77||||||||||-1.77|
71694189|NCT00791219|142902925|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
71694190|NCT00791219|142902926|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|10.38|||||ONE_SIDED|95.0|0.92|||||||To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|||0.92|
71694191|NCT00791219|142902926|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
71694192|NCT00791219|142902927|NON_INFERIORITY|To demonstrate non-inferiority an upper bound 95% confidence interval approach comparing the difference between the cure rate in the Test and the Reference groups was used. If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure and Mycological Cure as appropriate, at Week 24 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|3.17|||||ONE_SIDED|95.0|-10.62||||||||||-10.62|
71694193|NCT00791219|142902927|SUPERIORITY||||||<|0.05|||||||one-sided continuity corrected Z-test|||The ITT was used for all superiority testing. For the three primary endpoints and all four secondary endpoints, if the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing||||<0.05
71694194|NCT00791219|142902930|NON_INFERIORITY|If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|-20|-0.57|||||ONE_SIDED|95.0|-12.91|||||||If the lower bound 95% confidence interval of the difference between the proportion of patients in the Test group compared to the Reference group considered a Therapeutic Cure, Clinical Cure or Mycological Cure as appropriate at Visit 7 was greater than -20 then non-inferiority was considered to have been demonstrated|||-12.91|
71942301|NCT00437658|143405918|OTHER||Least squares mean|-5.5|||<|0.0001|TWO_SIDED|95.0|-6.2|-4.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.8|-6.2|< 0.0001
71761141|NCT04954833|143023926|NON_INFERIORITY|A non-inferiority margin of 10% was used. A 10% of difference in the rate of lens fit acceptance is considered clinically significant.|Posterior mean difference of proportions|0.0|STANDARD_DEVIATION|0.0048|||TWO_SIDED|95.0|-0.009|0.01|||Bayesian hierarchical model|A 95% credible interval for the posterior mean difference between the Test and Control (Test - Control) was used to evaluate non-inferiority.|Interval presented is a 95% Credible interval|||0.010|-0.009|
71761142|NCT01075685|143023927|SUPERIORITY_OR_OTHER|||||||0.0279||95.0|||||Type 3 tests of fixed effects|||||||0.0279
71942302|NCT00437658|143405918|OTHER||Least squares mean|-5.2|||<|0.0001|TWO_SIDED|95.0|-5.8|-4.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-4.5|-5.8|< 0.0001
71694195|NCT00791219|142902931|SUPERIORITY||Mean Difference (Final Values)|0.0018|||<|0.05|TWO_SIDED|||||It the difference between the proportion of patients considered a cure was statistically greater (p\<0.05) than the proportion of patients considered a cure in the Placebo group, then superiority was considered to have been demonstrated.|A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
71694196|NCT00791219|142902931|SUPERIORITY||Median Difference (Final Values)|0.0853|||<|0.05|TWO_SIDED||||||A one-sided continuity corrected Z-test|||For the three primary endpoints and all four dichotomous secondary endpoints, if the difference between the proportion of patients considered a cure in the Test or Reference group was statistically greater (p \< 0.05) than the proportion of patients considered a cure in the Placebo group, then superiority of that treatment over placebo was considered to have been demonstrated. A one-sided continuity corrected Z-test was used for superiority testing.||||<0.05
71694197|NCT01921517|142902948|SUPERIORITY|||||||0.0481|||||||t-test, 2 sided|||||||0.0481
71694198|NCT00643760|142902949|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.35||||0.295||95.0|-1.02|0.31||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.31|-1.02|0.295
71694199|NCT00643760|142902949|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.02||||0.946||95.0|-0.71|0.66||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.66|-0.71|0.946
71694200|NCT00643760|142902949|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|-0.55||||0.105||95.0|-1.1|0.01||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.||||0.01|-1.10|0.105
71694201|NCT00643760|142902949|SUPERIORITY_OR_OTHER||Adjusted mean difference versus placebo|0.43||||||95.0|-0.22|1.08||||||||1.08|-0.22|
71694202|NCT03934216|142902968|SUPERIORITY||Odds Ratio (OR)|0.9||||0.5935|TWO_SIDED|95.0|0.3|2.4|||Stratified Cochran-Mantel-Haenszel|||||2.4|0.3|0.5935
71694203|NCT03934216|142902969|SUPERIORITY||Odds Ratio (OR)|1.2||||0.3051|TWO_SIDED|95.0|0.6|2.7|||Stratified Cochran-Mantel-Haenszel|||||2.7|0.6|0.3051
71694204|NCT03934216|142902970|SUPERIORITY||Odds Ratio (OR)|0.6||||0.8764|TWO_SIDED|95.0|0.3|1.4|||Stratified Cochran-Mantel-Haenszel|||||1.4|0.3|0.8764
71694205|NCT03934216|142902971|SUPERIORITY||Odds Ratio (OR)|1.4||||0.2235|TWO_SIDED|95.0|0.5|3.8|||Stratified Cochran-Mantel-Haenszel|||||3.8|0.5|0.2235
71694206|NCT01063855|142902972|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|1.69|STANDARD_ERROR_OF_MEAN|0.43|<|0.001|TWO_SIDED|95.0|0.837|2.542||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|ANCOVA|ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.|Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF \>0.||2.542|0.837|<0.001
71694207|NCT01063855|142902973|SUPERIORITY_OR_OTHER||Risk Difference (RD)|13.6||||0.001|TWO_SIDED|95.0|4.9|22.3||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.|Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF \> 0.||22.3|4.9|0.001
71694208|NCT01063855|142902974|SUPERIORITY_OR_OTHER||Risk Difference (RD)|9.2||||0.013|TWO_SIDED|95.0|1.1|17.2||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).||17.2|1.1|0.013
71694209|NCT01063855|142902975|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.78||||0.002|TWO_SIDED|95.0|1.204|2.619||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.619|1.204|0.002
71761143|NCT01075685|143023928|SUPERIORITY_OR_OTHER|||||||0.0189||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0189
71761144|NCT01075685|143023929|SUPERIORITY_OR_OTHER|||||||0.009||95.0|||||Chi-squared|||||||0.009
71761145|NCT01075685|143023930|SUPERIORITY_OR_OTHER|||||||0.082||95.0|||||Chi-squared|||||||0.082
71942303|NCT00437658|143405918|OTHER||Least squares mean|-5.3|||<|0.0001|TWO_SIDED|95.0|-6.0|-4.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.6|-6.0|< 0.0001
71694210|NCT01063855|142902976|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.63||||0.007|TWO_SIDED|95.0|1.108|2.394||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||2.394|1.108|0.007
71761146|NCT02858362|143023937|OTHER|Difference in least square means. All 23 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.023|||||TWO_SIDED|95.0|-0.002|0.048||||||Week 24 Change from Baseline||0.048|-0.002|
71761147|NCT02858362|143023937|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.006|||||TWO_SIDED|95.0|-0.03|0.042||||||Week 48 Change from Baseline||0.042|-0.03|
71761148|NCT02858362|143023938|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-2.611|||||TWO_SIDED|95.0|-4.324|-0.898||||||Week 24 Change from Baseline||-0.898|-4.324|
71761149|NCT02858362|143023938|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|1.166|||||TWO_SIDED|95.0|-1.103|3.435||||||Week 48 Change from Baseline||3.435|-1.103|
71942304|NCT00437658|143405919|OTHER||Least squares mean|-4.6|||<|0.0001|TWO_SIDED|95.0|-5.1|-4.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-4.0|-5.1|<0.0001
71942305|NCT00437658|143405919|OTHER||Least squares mean|-4.4|||<|0.0001|TWO_SIDED|95.0|-5.0|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.0|<0.0001
71761150|NCT02858362|143023939|OTHER|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-1.837|||||TWO_SIDED|95.0|-3.989|0.315||||||Week 24 Change from Baseline||0.315|-3.989|
71761151|NCT02858362|143023939|OTHER|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|2.21|||||TWO_SIDED|95.0|0.096|4.324||||||Week 48 Change from Baseline||4.324|0.096|
71942306|NCT00437658|143405919|OTHER||Least squares mean|-4.5|||<|0.0001|TWO_SIDED|95.0|-5.1|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-3.9|-5.1|< 0.0001
71942307|NCT00437658|143405920|OTHER||Least squares mean|-1.5|||<|0.0001|TWO_SIDED|95.0|-1.7|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.7|< 0.0001
71942308|NCT00437658|143405920|OTHER||Least squares mean|-1.4|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.2|-1.6|< 0.0001
71942309|NCT00437658|143405920|OTHER||Least squares mean|-1.7|||<|0.0001|TWO_SIDED|95.0|-1.9|-1.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-1.4|-1.9|< 0.0001
71942310|NCT00437658|143405921|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-0.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.9|-1.4|< 0.0001
71942311|NCT00437658|143405921|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|2.0|-1.2|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.2|< 0.0001
71942312|NCT00437658|143405921|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.5|-1.1|< 0.0001
71942313|NCT00437658|143405922|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
71761152|NCT01262989|143023956|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.95||||||90.0|97.17|109.07|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||109.07|97.17|
71694211|NCT01063855|142902977|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.42|||<|0.001|TWO_SIDED|95.0|1.642|3.568||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.568|1.642|<0.001
71694212|NCT01063855|142902978|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33|||>|0.05|TWO_SIDED|95.0|0.897|1.965||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.||1.965|0.897|>0.05
71694213|NCT01063855|142902979|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.21|||<|0.001|TWO_SIDED|95.0|1.425|3.423||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.||3.423|1.425|<0.001
71694214|NCT00048035|142903015|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.38|||||TWO_SIDED|90.0|0.32|0.42|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb.|All cohorts with dosing frequency 1 X / Week||0.42|0.32|
71694215|NCT00048035|142903015|SUPERIORITY_OR_OTHER||Estimated Conversion Factor 90% CI|0.61|||||TWO_SIDED|90.0|0.53|0.76|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change.|All cohorts with dosing frequency 1 X /2 Week||0.76|0.53|
71694216|NCT02619617|142903021|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|1.308||||0.698|TWO_SIDED|90.0|0.419|4.082|||Regression, Logistic|||||4.082|0.419|0.698
71694217|NCT02619617|142903022|OTHER|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|2.033||||0.385|TWO_SIDED|90.0|0.53|7.79|||Regression, Logistic|||||7.790|0.530|0.385
71694218|NCT01854697|142903043|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|14.7|||||TWO_SIDED|95.0|1.3|28.2|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||28.2|1.3|
71694219|NCT01854697|142903043|NON_INFERIORITY_OR_EQUIVALENCE|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
71694220|NCT01854697|142903044|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|2.13|STANDARD_ERROR_OF_MEAN|2.28||0.351|TWO_SIDED|95.0|-2.39|6.65|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||6.65|-2.39|0.351
71694221|NCT01854697|142903044|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.83|STANDARD_ERROR_OF_MEAN|1.84||0.002|TWO_SIDED|95.0|2.19|9.47|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.47|2.19|0.002
71694222|NCT01854697|142903044|SUPERIORITY_OR_OTHER||Least Squares Mean of Difference|5.28|STANDARD_ERROR_OF_MEAN|1.65||0.002|TWO_SIDED|95.0|2.01|8.54|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.54|2.01|0.002
71694223|NCT01854697|142903045|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.08|STANDARD_ERROR_OF_MEAN|1.69|<|0.001|TWO_SIDED|95.0|2.72|9.44|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.44|2.72|<0.001
71694224|NCT01854697|142903045|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.2|STANDARD_ERROR_OF_MEAN|1.34|<|0.001|TWO_SIDED|95.0|3.55|8.85|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||8.85|3.55|<0.001
71694225|NCT01854697|142903045|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|6.86|STANDARD_ERROR_OF_MEAN|1.27|<|0.001|TWO_SIDED|95.0|4.36|9.37|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.||||9.37|4.36|<0.001
71694226|NCT01854697|142903046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|7.2||||0.021|TWO_SIDED|95.0|1.4|38.0|||Regression, Logistic|Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.||||38.0|1.4|0.021
71694227|NCT01854697|142903046|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|20.8|||||TWO_SIDED|95.0|7.9|33.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||33.6|7.9|
71694228|NCT01854697|142903046|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|28.2||||0.002|TWO_SIDED|95.0|3.3|241.1|||Regression, Logistic|Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.||||241.1|3.3|0.002
71694229|NCT01854697|142903046|SUPERIORITY_OR_OTHER|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).||||||0.005
71694230|NCT01854697|142903049|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|13.3|||||TWO_SIDED|95.0|-0.4|27.0|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.|||27.0|-0.4|
71694231|NCT01854697|142903049|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.6|||||TWO_SIDED|95.0|6.5|32.7|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.7|6.5|
71942314|NCT00437658|143405922|OTHER||Least squares mean|-1.2|||<|0.0001|TWO_SIDED|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-1.0|-1.4|< 0.0001
71942315|NCT00437658|143405922|OTHER||Least squares mean|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."||-0.8|-1.3|< 0.0001
71942316|NCT00437658|143405923|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.2|< 0.0001
71942317|NCT00437658|143405923|OTHER||Least squares mean|-1.0|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.8|-1.1|< 0.0001
71942318|NCT00437658|143405923|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
71942319|NCT00437658|143405924|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.0|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.0|< 0.0001
71942320|NCT00437658|143405924|OTHER||Least squares mean|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.7|-1.1|< 0.0001
71942321|NCT00437658|143405924|OTHER||Least squares mean|-0.8|||<|0.0001|TWO_SIDED|95.0|-0.9|-0.6|||t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-0.6|-0.9|<0.0001
71694232|NCT01854697|142903049|NON_INFERIORITY_OR_EQUIVALENCE|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||TWO_SIDED|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.|||32.6|6.4|
71694233|NCT00974311|142903050|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.63|||<|0.0001|TWO_SIDED|95.0|0.53|0.75|||Log Rank|Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.75|0.53|<0.0001
71694234|NCT00974311|142903051|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.4|||<|0.0001|TWO_SIDED|95.0|0.35|0.47|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.47|0.35|<0.0001
71694235|NCT00974311|142903052|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.69||||0.0001|TWO_SIDED|95.0|0.566|0.835|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.835|0.566|0.0001
71942322|NCT00437658|143405925|OTHER||Least squares mean|-32.3|||<|0.0001|TWO_SIDED|95.0|-39.2|-25.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-25.4|-39.2|< 0.0001
71942323|NCT00437658|143405925|OTHER||Least squares mean|-32.9|||<|0.0001|TWO_SIDED|95.0|-39.4|-26.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-26.4|-39.4|< 0.0001
71942324|NCT00437658|143405925|OTHER||Least squares mean|-35.8|||<|0.0001|TWO_SIDED|95.0|-43.0|-28.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-28.6|-43.0|< 0.0001
71942325|NCT00437658|143405926|OTHER||Least squares mean|-18.2|||<|0.0001|TWO_SIDED|95.0|-23.3|-13.1||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-13.1|-23.3|< 0.0001
71942326|NCT00437658|143405926|OTHER||Least squares mean|-23.4|||<|0.0001|TWO_SIDED|95.0|-28.3|-18.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-18.5|-28.3|< 0.0001
71942327|NCT00437658|143405926|OTHER||Least squares mean|-17.9|||<|0.0001|TWO_SIDED|95.0|-23.1|-12.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.||-12.7|-23.1|< 0.0001
71942328|NCT02731157|143405943|OTHER||Mean Difference (Final Values)|0.65||||0.95|TWO_SIDED||||||ANOVA|||||||0.95
71942329|NCT01014728|143405952|SUPERIORITY_OR_OTHER|||||||0.937||95.0|||||t-test, 2 sided|||||||0.937
71942330|NCT01014728|143405953|SUPERIORITY_OR_OTHER|||||||0.002||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.002
71942331|NCT01014728|143405954|SUPERIORITY_OR_OTHER|||||||0.461||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.461
71942332|NCT02096718|143406002|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.23|STANDARD_DEVIATION|28.3|||TWO_SIDED|90.0|95.743|156.045|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||156.045|95.743|
71942333|NCT02096718|143406002|SUPERIORITY_OR_OTHER||Ratio of gmeans|149.97|STANDARD_DEVIATION|41.9|||TWO_SIDED|90.0|105.266|213.671|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.671|105.266|
71942334|NCT02096718|143406003|SUPERIORITY_OR_OTHER||Ratio of gmeans|101.16|STANDARD_DEVIATION|38.5|||TWO_SIDED|90.0|72.931|140.309|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||140.309|72.931|
71942335|NCT02096718|143406003|SUPERIORITY_OR_OTHER||Ratio of gmeans|121.71|STANDARD_DEVIATION|34.2|||TWO_SIDED|90.0|90.79|163.162|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||163.162|90.790|
71694236|NCT00974311|142903053|SUPERIORITY_OR_OTHER||Difference in Percentage of Participants|24.9|||<|0.0001|TWO_SIDED|95.0|18.8|30.9|||Cochran-Mantel-Haenszel|Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Confidence Interval based on standard normal approximation.|||30.9|18.8|<0.0001
71694237|NCT00974311|142903054|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.248|||<|0.0001|TWO_SIDED|95.0|0.204|0.303||Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).|Log Rank||Hazard Ratio and 95% confidence interval are from Cox regression model.|||0.303|0.204|<0.0001
71694238|NCT00974311|142903055|SUPERIORITY_OR_OTHER||Difference in Rate of Pain Palliation|38.2||||0.0079|TWO_SIDED|95.0|19.4|57.0|||Cochran-Mantel-Haenszel|Stratified by baseline Eastern Cooperative Oncology Group performance status (0-1 vs. 2).|Confidence Interval based on standard normal approximation.|||57.0|19.4|0.0079
71694239|NCT03677635|142903068|OTHER||Standardised Effect Size|0.32|||||TWO_SIDED|95.0|0.21|0.86|||Standardised Effect Size|||||.86|.21|
71694240|NCT03677635|142903069|OTHER|Cohen's d was reported.|Mean Difference (Final Values)|-0.05|||||TWO_SIDED|95.0|-0.59|0.48|||Standardised Effect Size|||||.48|-.59|
71694241|NCT02157519|142903074|SUPERIORITY||Odds Ratio (OR)|0.56||||0.186|TWO_SIDED|95.0|0.23|1.33||threshold p \<0.05|Regression, Logistic|Adjusted for baseline MMAS-4 scores (dichotomous) and change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.||1.33|0.23|0.186
71694242|NCT02157519|142903075|SUPERIORITY||Mean Difference (Final Values)|-2.34|STANDARD_ERROR_OF_MEAN|4.06||0.57|TWO_SIDED|95.0|-10.35|5.68||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||5.68|-10.35|0.57
71694243|NCT02157519|142903076|SUPERIORITY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.21||0.603|TWO_SIDED|95.0|-0.31|0.53||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.53|-0.31|0.603
71694244|NCT02157519|142903076|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.33||0.982|TWO_SIDED|95.0|-0.64|0.65||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.||0.65|-0.64|0.982
71694245|NCT02157519|142903077|SUPERIORITY||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.65||0.144|TWO_SIDED|95.0|-5.66|0.83||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.83|-5.66|0.144
71694246|NCT02157519|142903077|SUPERIORITY||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.66||0.294|TWO_SIDED|95.0|-2.0|0.61||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.||0.61|-2.00|0.294
71694247|NCT02157519|142903077|SUPERIORITY||Mean Difference (Final Values)|-1.67|STANDARD_ERROR_OF_MEAN|0.74||0.025|TWO_SIDED|95.0|-3.12|-0.21||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||-0.21|-3.12|0.025
71694248|NCT02157519|142903077|SUPERIORITY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.58||0.392|TWO_SIDED|95.0|-0.64|1.63||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||1.63|-0.64|0.392
71694249|NCT02157519|142903077|SUPERIORITY||Mean Difference (Final Values)|-0.75|STANDARD_ERROR_OF_MEAN|0.6||0.216|TWO_SIDED|95.0|-1.94|0.44||threshold p \<0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.44|-1.94|0.216
71694250|NCT02157519|142903078|SUPERIORITY||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|0.28||0.17|TWO_SIDED|95.0|-0.93|0.17||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.17|-0.93|0.170
71694251|NCT02157519|142903078|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.057|TWO_SIDED|95.0|-0.72|0.01||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.01|-0.72|0.057
71942336|NCT02096718|143406004|SUPERIORITY_OR_OTHER||Ratio of gmeans|122.44|STANDARD_DEVIATION|28.0|||TWO_SIDED|90.0|96.141|155.928|||ANOVA||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||155.928|96.141|
71694252|NCT02157519|142903078|SUPERIORITY||Mean Difference (Final Values)|-0.97|STANDARD_ERROR_OF_MEAN|0.72||0.178|TWO_SIDED|95.0|-2.39|0.45||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.45|-2.39|0.178
71694253|NCT02157519|142903078|SUPERIORITY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.28||0.481|TWO_SIDED|95.0|-0.35|0.75||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.75|-0.35|0.481
71694254|NCT02157519|142903078|SUPERIORITY||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.97|TWO_SIDED|95.0|-0.34|0.35||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.35|-0.34|0.970
71694255|NCT02157519|142903079|SUPERIORITY||Mean Difference (Final Values)|-0.03|STANDARD_ERROR_OF_MEAN|0.06||0.682|TWO_SIDED|95.0|-0.15|0.1||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.||0.10|-0.15|0.682
71694256|NCT02157519|142903080|SUPERIORITY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.64|TWO_SIDED|95.0|-0.24|0.15||threshold p \< 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment||0.15|-0.24|0.640
71694257|NCT01656395|142903081|SUPERIORITY||Mean Difference (Final Values)|0.022||||0.685|TWO_SIDED|95.0|-0.084|0.127|||cLDA model|||Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.127|-0.084|0.685
71694258|NCT01656395|142903081|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.477|TWO_SIDED|95.0|-0.149|0.07|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.07|-0.149|0.477
71694259|NCT01656395|142903081|SUPERIORITY||Mean Difference (Final Values)|0.019||||0.733|TWO_SIDED|95.0|-0.092|0.13|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.13|-0.092|0.733
71694260|NCT01656395|142903081|SUPERIORITY||Mean Difference (Final Values)|-0.008||||0.89|TWO_SIDED|95.0|-0.115|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.115|0.89
71694261|NCT01656395|142903081|SUPERIORITY||Mean Difference (Final Values)|-0.004||||0.935|TWO_SIDED|95.0|-0.109|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.1|-0.109|0.935
71694262|NCT01656395|142903084|SUPERIORITY||Mean Difference (Final Values)|-7.2||||0.169|TWO_SIDED|95.0|-17.48|3.08|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||3.08|-17.48|0.169
71694263|NCT01656395|142903084|SUPERIORITY||Mean Difference (Final Values)|-9.092||||0.092|TWO_SIDED|95.0|-19.67|1.485|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.485|-19.67|0.092
71694264|NCT01656395|142903084|SUPERIORITY||Mean Difference (Final Values)|-9.469||||0.083|TWO_SIDED|95.0|-20.19|1.25|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||1.25|-20.19|0.083
71694265|NCT01656395|142903084|SUPERIORITY||Mean Difference (Final Values)|-4.666||||0.367|TWO_SIDED|95.0|-14.83|5.501|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||5.501|-14.83|0.367
71694266|NCT01656395|142903084|SUPERIORITY||Mean Difference (Final Values)|-5.247||||0.308|TWO_SIDED|95.0|-15.36|4.871|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||4.871|-15.36|0.308
71942337|NCT02096718|143406004|SUPERIORITY_OR_OTHER||Ratio of gmeans|150.08|STANDARD_DEVIATION|41.5|||TWO_SIDED|90.0|105.626|213.25|||ANOVA||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.||213.250|105.626|
71942338|NCT01874951|143406041|NON_INFERIORITY_OR_EQUIVALENCE|An initial power analysis at the time of protocol development suggested that with 6 patients in each treatment group, we could expect a 79% chance of achieving significance (2-sided p \< 0.05) if the true response rate to low-dose naltrexone (LDN) was 80% and the true placebo response rate was 20%.||||||0.55||||||Threshold of statistical significance is 0.05.|Chi-squared|Chi-squared value was 1.5.||Response rates were based on attaining a reduction in the HAM-D-17 scale of 50% or greater compared to baseline. We hypothesized that naltrexone would produce a significantly greater response rate than placebo.||||0.55
71942339|NCT02158936|143406073|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.37||||1|TWO_SIDED|95.0|0.21|0.65||One sided p value|Cochran-Mantel-Haenszel|Stratified by Interactive Voice Response System (IVRS) stratification factors||||0.65|0.21|1.000
71942340|NCT02158936|143406074|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.42||||0.164|TWO_SIDED|95.0|0.97|2.08|||Log Rank|||Confidence Intervals estimated using the Brookmeyer-Crowley method. Hazard ratios are estimated using the Pike estimator. A hazard ratio \<1 indicates a lower risk with eltrombopag compared with Placebo. Log-rank test stratified by IVRS stratification factors||2.08|0.97|0.164
71942341|NCT02158936|143406091|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.31|||||TWO_SIDED|90.0|0.99|1.74|||ANOVA|||||1.74|0.990|
71942342|NCT02158936|143406092|SUPERIORITY_OR_OTHER||Geometric mean ratio|1.39|||||TWO_SIDED|90.0|0.97|1.99|||ANOVA|||||1.99|0.970|
71942343|NCT00234078|143406107|SUPERIORITY_OR_OTHER|||||||0.385||||||versus placebo|t-test, 2 sided|a general linear model||||||0.385
71942344|NCT00234078|143406108|SUPERIORITY_OR_OTHER|||||||0.601||||||versus placebo|t-test, 2 sided|a general linear model||||||0.601
71942345|NCT00234078|143406109|SUPERIORITY_OR_OTHER|||||||0.084||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.084
71942346|NCT00234078|143406109|SUPERIORITY_OR_OTHER|||||||0.02||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.020
71942347|NCT00234078|143406109|SUPERIORITY_OR_OTHER|||||||0.421||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.421
71942348|NCT00234078|143406110|SUPERIORITY_OR_OTHER|||||||0.087||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.087
71942349|NCT00234078|143406110|SUPERIORITY_OR_OTHER|||||||0.004||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.004
71942350|NCT00234078|143406110|SUPERIORITY_OR_OTHER|||||||0.029||||||p-value is adjusted for multiple comparisons|t-test, 2 sided|||||||0.029
71942351|NCT03290326|143406131|OTHER||||||<|0.01|||||||ANOVA|||One-way ANOVA was conducted to compare the effect of 40Hz tACS on EEG gamma-band spectral power. Power changes were expressed as percentage relative power variations, accordingly with the event-related synchronization/desynchronization (ERS/ERD) index.||||< 0.01
71942352|NCT03422653|143406135|SUPERIORITY||Odds Ratio (OR)|2.72|||<|0.001|TWO_SIDED|95.0|1.72|4.3|||Cui, Hung, Wang|||||4.30|1.72|<0.001
71942353|NCT03422653|143406136|SUPERIORITY||Mean Difference (Final Values)|-1.3|STANDARD_ERROR_OF_MEAN|0.38|<|0.001|TWO_SIDED|95.0|-2.0|-0.5|||ANCOVA|||||-0.5|-2.0|<0.001
71942354|NCT03422653|143406137|SUPERIORITY||Mean Difference (Final Values)|-5.1|STANDARD_ERROR_OF_MEAN|1.44|<|0.001|TWO_SIDED|95.0|-8.0|-2.3|||ANCOVA|||||-2.3|-8.0|<0.001
71942355|NCT03422653|143406138|SUPERIORITY||Odds Ratio (OR)|2.89|||<|0.001|TWO_SIDED|95.0|1.75|4.76|||Cui, Hung, Wang|||||4.76|1.75|<0.001
71942356|NCT01101022|143406139|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.2|||<|0.0001|TWO_SIDED|95.0|-15.9|-6.4|||ANCOVA|||||-6.4|-15.9|<0.0001
71942357|NCT01101022|143406140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.6|||<|0.0001|TWO_SIDED|95.0|13.5|29.7|||ANCOVA|||Performance and Daily Functioning||29.7|13.5|<0.0001
71942358|NCT01101022|143406140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.9|||<|0.0001|TWO_SIDED|95.0|7.8|22.0|||ANCOVA|||Daily Interference||22.0|7.8|<0.0001
71942359|NCT01101022|143406140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|13.5||||0.0003|TWO_SIDED|95.0|6.3|20.7|||ANCOVA|||Bother/Concern||20.7|6.3|0.0003
71942360|NCT01101022|143406140|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.8||||0.0302|TWO_SIDED|95.0|0.8|14.9|||ANCOVA|||Relationships/Communication||14.9|0.8|0.0302
71942361|NCT01101022|143406141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0016|TWO_SIDED|95.0|-7.8|-1.9|||ANCOVA|||Global Executive Composite||-1.9|-7.8|0.0016
71942362|NCT01101022|143406141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.1||||0.0355|TWO_SIDED|95.0|-6.0|-0.2|||ANCOVA|||Behavioral Regulation Index||-0.2|-6.0|0.0355
71942363|NCT01101022|143406141|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.7||||0.0003|TWO_SIDED|95.0|-8.7|-2.7|||ANCOVA|||Metacognition Index||-2.7|-8.7|0.0003
71942364|NCT01101022|143406142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.4||||0.0002|TWO_SIDED|95.0|-12.7|-4.0|||ANCOVA|||Behavioral Regulation Index||-4.0|-12.7|0.0002
71942365|NCT01101022|143406142|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.6|||<|0.0001|TWO_SIDED|95.0|-16.3|-7.0|||ANCOVA|||Metacognition Index||-7.0|-16.3|<0.0001
71942366|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.3||||0.0001|TWO_SIDED|95.0|-12.6|-4.1|||ANCOVA|||Inhibit||-4.1|-12.6|0.0001
71942367|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.7||||0.0018|TWO_SIDED|95.0|-10.8|-2.5|||ANCOVA|||Shift||-2.5|-10.8|0.0018
71942368|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.2||||0.0056|TWO_SIDED|95.0|-8.8|-1.5|||ANCOVA|||Emotional control||-1.5|-8.8|0.0056
71942369|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.2||||0.0001|TWO_SIDED|95.0|-12.3|-4.1|||ANCOVA|||Sef-monitor||-4.1|-12.3|0.0001
71942370|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3|||<|0.0001|TWO_SIDED|95.0|-13.2|-5.4|||ANCOVA|||Initiate||-5.4|-13.2|<0.0001
71942371|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.3|||<|0.0001|TWO_SIDED|95.0|-16.0|-6.6|||ANCOVA|||Working memory||-6.6|-16.0|<0.0001
71942372|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-10.9|||<|0.0001|TWO_SIDED|95.0|-15.4|-6.4|||ANCOVA|||Plan/Organize||-6.4|-15.4|<0.0001
71942373|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.3||||0.0001|TWO_SIDED|95.0|-14.0|-4.7|||ANCOVA|||Task monitor||-4.7|-14.0|0.0001
71942374|NCT01101022|143406143|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.9|||<|0.0001|TWO_SIDED|95.0|-12.5|-5.3|||ANCOVA|||Organization of materials||-5.3|-12.5|<0.0001
71942375|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0048|TWO_SIDED|95.0|-7.4|-1.4|||ANCOVA|||Inhibit||-1.4|-7.4|0.0048
71942376|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.8||||0.0045|TWO_SIDED|95.0|-8.0|-1.5|||ANCOVA|||Shift||-1.5|-8.0|0.0045
71942377|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.3||||0.3605|TWO_SIDED|95.0|-4.0|1.5|||ANCOVA|||Emotional control||1.5|-4.0|0.3605
71942378|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.2||||0.1468|TWO_SIDED|95.0|-5.1|0.8|||ANCOVA|||Self-monitor||0.8|-5.1|0.1468
71942379|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0002|TWO_SIDED|95.0|-8.3|-2.7|||ANCOVA|||Initiate||-2.7|-8.3|0.0002
71942380|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0004|TWO_SIDED|95.0|-9.8|-2.9|||ANCOVA|||Working memory||-2.9|-9.8|0.0004
71942381|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.9||||0.0015|TWO_SIDED|95.0|-7.9|-1.9|||ANCOVA|||Plan/Organize||-1.9|-7.9|0.0015
71942382|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.3||||0.0003|TWO_SIDED|95.0|-9.7|-2.9|||ANCOVA|||Task monitor||-2.9|-9.7|0.0003
71942383|NCT01101022|143406144|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.2||||0.0234|TWO_SIDED|95.0|-5.9|-0.4|||ANCOVA|||Organization of materials||-0.4|-5.9|0.0234
71942384|NCT01101022|143406145|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-11.1|||<|0.0001|TWO_SIDED|95.0|-14.9|-7.3|||ANCOVA|||||-7.3|-14.9|<0.0001
71942385|NCT01101022|143406148|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0|||||Chi-squared|||||||<0.0001
71942386|NCT01101022|143406149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|9.1|||<|0.0001|TWO_SIDED|95.0|5.4|12.7|||ANCOVA|||Living with ADHD||12.7|5.4|<0.0001
71942387|NCT01101022|143406149|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|10.8|||<|0.0001|TWO_SIDED|95.0|6.0|15.5|||ANCOVA|||General Well-being||15.5|6.0|<0.0001
71942388|NCT01101022|143406150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.5||||0.0184|TWO_SIDED|95.0|0.1|1.0|||ANCOVA|||Question 1||1.0|0.1|0.0184
71942389|NCT01101022|143406150|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.6||||0.0004|TWO_SIDED|95.0|-0.9|-0.3|||ANCOVA|||Question 4||-0.3|-0.9|0.0004
71942390|NCT01101022|143406151|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.5||||0.0019|TWO_SIDED|95.0|-9.0|-2.1|||ANCOVA|||||-2.1|-9.0|0.0019
71942391|NCT01101022|143406152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-5.1||||0.0017|TWO_SIDED|95.0|-8.2|-1.9|||ANCOVA|||Inattention/Memory Problems||-1.9|-8.2|0.0017
71942392|NCT01101022|143406152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.1||||0.0174|TWO_SIDED|95.0|-7.5|-0.7|||ANCOVA|||Hyperactivity/Restlessness||-0.7|-7.5|0.0174
71942393|NCT01101022|143406152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.0||||0.0063|TWO_SIDED|95.0|-6.8|-1.1|||ANCOVA|||Impulsivity/Emotional Liability||-1.1|-6.8|0.0063
71942394|NCT01101022|143406152|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.4||||0.0059|TWO_SIDED|95.0|-7.5|-1.3|||ANCOVA|||Problems with Self-concept||-1.3|-7.5|0.0059
71942395|NCT01101022|143406153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|21.0||||0.0016|TWO_SIDED|95.0|8.4|33.6|||ANCOVA|||Life Productivity||33.6|8.4|0.0016
71942396|NCT01101022|143406153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.1||||0.0242|TWO_SIDED|95.0|1.6|22.5|||ANCOVA|||Psychological Health||22.5|1.6|0.0242
71942397|NCT01101022|143406153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|12.5||||0.0038|TWO_SIDED|95.0|4.2|20.8|||ANCOVA|||Life Outlook||20.8|4.2|0.0038
71942398|NCT01101022|143406153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|7.3||||0.1752|TWO_SIDED|95.0|-3.4|18.0|||ANCOVA|||Relationships||18.0|-3.4|0.1752
71942399|NCT01101022|143406153|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|14.7||||0.0015|TWO_SIDED|95.0|5.9|23.6|||ANCOVA|||Total Score||23.6|5.9|0.0015
71942400|NCT05818137|143406200|OTHER||Change from baseline estimate|-99.2|||||TWO_SIDED|95.0|-129.6|-68.4|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-68.4|-129.6|
71942401|NCT05818137|143406203|OTHER||Change from baseline estimate|41.8|||||TWO_SIDED|95.0|27.8|55.5|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||55.5|27.8|
71942402|NCT05818137|143406205|OTHER||Change from baseline estimate|-48.5|||||TWO_SIDED|95.0|-77.0|-24.8|||||The change from baseline estimate and associated 95% confidence interval (CI) based on the Hodges-Lehmann method.|||-24.8|-77.0|
71942403|NCT02532764|143406218|SUPERIORITY||Difference vs placebo|12.91|STANDARD_ERROR_OF_MEAN|6.53||0.0592|TWO_SIDED|95.0|-0.54|26.35||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||26.35|-0.54|0.0592
71942404|NCT02532764|143406218|SUPERIORITY||difference vs placebo|19.13|STANDARD_ERROR_OF_MEAN|6.56||0.0074|TWO_SIDED|95.0|5.62|32.64||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||32.64|5.62|0.0074
71942405|NCT02532764|143406218|SUPERIORITY||difference vs placebo|14.24|STANDARD_ERROR_OF_MEAN|6.6||0.0408|TWO_SIDED|95.0|0.64|27.83||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||27.83|0.64|0.0408
71942406|NCT02532764|143406218|SUPERIORITY||difference vs placebo|3.46|STANDARD_ERROR_OF_MEAN|6.87||0.6193|TWO_SIDED|95.0|-10.69|17.6||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||17.60|-10.69|0.6193
71942407|NCT02532764|143406220|SUPERIORITY||Difference vs placebo|23.17|STANDARD_ERROR_OF_MEAN|9.73||0.0321|TWO_SIDED|95.0|2.29|44.04||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||44.04|2.29|0.0321
71942408|NCT02532764|143406220|SUPERIORITY||Difference vs placebo|27.3|STANDARD_ERROR_OF_MEAN|9.17||0.01|TWO_SIDED|95.0|7.64|46.96||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||46.96|7.64|0.0100
71942409|NCT02532764|143406220|SUPERIORITY||Difference vs placebo|20.16|STANDARD_ERROR_OF_MEAN|8.62||0.0346|TWO_SIDED|95.0|1.68|38.64||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||38.64|1.68|0.0346
71942410|NCT02532764|143406220|SUPERIORITY||Difference vs placebo|10.84|STANDARD_ERROR_OF_MEAN|9.01||0.2485|TWO_SIDED|95.0|-8.47|30.16||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.||30.16|-8.47|0.2485
71942411|NCT02532764|143406222|SUPERIORITY||difference vs placebo|4.24|STANDARD_ERROR_OF_MEAN|3.18||0.1938|TWO_SIDED|95.0|-2.3|10.79||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariate||10.79|-2.30|0.1938
71942412|NCT02532764|143406222|SUPERIORITY||difference vs placebo|2.75|STANDARD_ERROR_OF_MEAN|3.18||0.3943|TWO_SIDED|95.0|-3.79|9.29||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||9.29|-3.79|0.3943
71942413|NCT02532764|143406222|SUPERIORITY||difference vs placebo|0.53|STANDARD_ERROR_OF_MEAN|3.18||0.8688|TWO_SIDED|95.0|-6.01|7.07||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||7.07|-6.01|0.8688
71942414|NCT02532764|143406222|SUPERIORITY||difference vs placebo|-0.51|STANDARD_ERROR_OF_MEAN|3.35||0.8813|TWO_SIDED|95.0|-7.41|6.39||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.||6.39|-7.41|0.8813
71942415|NCT02532764|143406224|SUPERIORITY||Difference vs placebo|10.19|STANDARD_ERROR_OF_MEAN|4.22||0.0301|TWO_SIDED|95.0|1.13|19.25||P-values are presented for Day 33|Mixed Models Analysis|||||19.25|1.13|0.0301
71942416|NCT02532764|143406224|SUPERIORITY||Difference vs placebo|7.99|STANDARD_ERROR_OF_MEAN|3.91||0.0601|TWO_SIDED|95.0|-0.39|16.37||P-values are presented for Day 33|Mixed Models Analysis|||||16.37|-0.39|0.0601
71942417|NCT02532764|143406224|SUPERIORITY||Difference vs placebo|3.5|STANDARD_ERROR_OF_MEAN|3.69||0.358|TWO_SIDED|95.0|-4.4|11.41||P-values are presented for Day 33|Mixed Models Analysis|||||11.41|-4.40|0.3580
71942418|NCT02532764|143406224|SUPERIORITY||Difference vs placebo|3.21|STANDARD_ERROR_OF_MEAN|3.89||0.4224|TWO_SIDED|95.0|-5.13|11.55||P-values are presented for Day 33|Mixed Models Analysis|||||11.55|-5.13|0.4224
71942419|NCT01604850|143406235|SUPERIORITY_OR_OTHER||Proportion difference|-22.4|||<|0.001|TWO_SIDED|95.0|-34.4|-10.3||P-value is from the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization stratification factor (ie, presence/absence of cirrhosis, genotype 2 or 3).|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 100 subjects in each group would provide over 97% power to detect at least 20% improvement in SVR12 rate from the assumed null rate of 25% using 2-sided exact 1-sample binomial test at significance level of 0.025.||-10.3|-34.4|< 0.001
71694267|NCT01656395|142903085|SUPERIORITY||Mean Difference (Final Values)|-0.122||||0.429|TWO_SIDED|95.0|-0.427|0.182|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.182|-0.427|0.429
71694268|NCT01656395|142903085|SUPERIORITY||Mean Difference (Final Values)|0.142||||0.37|TWO_SIDED|95.0|-0.169|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.169|0.370
71694269|NCT01656395|142903085|SUPERIORITY||Mean Difference (Final Values)|-0.089||||0.579|TWO_SIDED|95.0|-0.402|0.225|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.225|-0.402|0.579
71942420|NCT00637299|143406247|SUPERIORITY_OR_OTHER||||||<|0.01||95.0|||||t-test, 1 sided|||||||<0.01
71942421|NCT00637299|143406248|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||t-test, 1 sided|||||||<0.05
71942422|NCT00864097|143406280|SUPERIORITY_OR_OTHER_LEGACY||Least Squares (LS) Mean Difference|-0.42|STANDARD_ERROR_OF_MEAN|0.2||0.039|TWO_SIDED|95.0|-0.81|-0.02|||ANCOVA|||LS means were estimated from the corresponding analysis of covariance (ANCOVA) model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.81|0.039
71942423|NCT00864097|143406280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.2||0.011|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.011
71942424|NCT00864097|143406280|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.57|STANDARD_ERROR_OF_MEAN|0.2||0.005|TWO_SIDED|95.0|-0.97|-0.17|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.17|-0.97|0.005
71942425|NCT00864097|143406281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.51|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED|95.0|-0.91|-0.12|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.12|-0.91|0.010
71942426|NCT00864097|143406281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.63|STANDARD_ERROR_OF_MEAN|0.2||0.002|TWO_SIDED|95.0|-1.03|-0.23|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.23|-1.03|0.002
71694270|NCT01656395|142903085|SUPERIORITY||Mean Difference (Final Values)|0.156||||0.305|TWO_SIDED|95.0|-0.142|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.454|-0.142|0.305
71694271|NCT01656395|142903085|SUPERIORITY||Mean Difference (Final Values)|-0.136||||0.372|TWO_SIDED|95.0|-0.434|0.163|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.163|-0.434|0.372
71694272|NCT01656395|142903086|SUPERIORITY||Mean Difference (Final Values)|-0.528||||0.114|TWO_SIDED|95.0|-1.184|0.128|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.128|-1.184|0.114
71694273|NCT01656395|142903086|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.827|TWO_SIDED|95.0|-0.75|0.6|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.6|-0.75|0.827
71694274|NCT01656395|142903086|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.75|TWO_SIDED|95.0|-0.789|0.569|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.569|-0.789|0.75
71694275|NCT01656395|142903086|SUPERIORITY||Mean Difference (Final Values)|0.275||||0.403|TWO_SIDED|95.0|-0.371|0.921|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.921|-0.371|0.403
71694276|NCT01656395|142903086|SUPERIORITY||Mean Difference (Final Values)|-0.389||||0.237|TWO_SIDED|95.0|-1.035|0.257|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.257|-1.035|0.237
71694277|NCT01656395|142903087|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.565|TWO_SIDED|95.0|-1.066|0.583|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.583|-1.066|0.565
71694278|NCT01656395|142903087|SUPERIORITY||Mean Difference (Final Values)|0.135||||0.754|TWO_SIDED|95.0|-0.713|0.983|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.983|-0.713|0.754
71694279|NCT01656395|142903087|SUPERIORITY||cLDA model|-0.251||||0.563|TWO_SIDED|95.0|-1.104|0.603|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.603|-1.104|0.563
71694280|NCT01656395|142903087|SUPERIORITY||Mean Difference (Final Values)|-0.241||||0.559|TWO_SIDED|95.0|-1.053|0.571|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.571|-1.053|0.559
71942427|NCT00864097|143406281|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.1|-0.3|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.30|-1.10|<0.001
71942428|NCT00864097|143406282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.17|STANDARD_ERROR_OF_MEAN|0.08||0.022|TWO_SIDED|95.0|-0.32|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.32|0.022
71694281|NCT01656395|142903087|SUPERIORITY||Mean Difference (Final Values)|-0.071||||0.863|TWO_SIDED|95.0|-0.883|0.741|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.741|-0.883|0.863
71694282|NCT01656395|142903088|SUPERIORITY||Mean Difference (Final Values)|0.544||||0.958|TWO_SIDED|95.0|-19.92|21.007|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||21.007|-19.92|0.958
71694283|NCT01656395|142903088|SUPERIORITY||Mean Difference (Final Values)|6.251||||0.559|TWO_SIDED|95.0|-14.81|27.307|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||27.307|-14.81|0.559
71942429|NCT00864097|143406282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.02|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.020
71694284|NCT01656395|142903088|SUPERIORITY||Median Difference (Final Values)|9.575||||0.374|TWO_SIDED|95.0|-11.62|30.766|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||30.766|-11.62|0.374
71694285|NCT01656395|142903088|SUPERIORITY||Mean Difference (Final Values)|5.114||||0.618|TWO_SIDED|95.0|-15.04|25.272|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||25.272|-15.04|0.618
71694286|NCT01656395|142903088|SUPERIORITY||Mean Difference (Final Values)|-1.604||||0.876|TWO_SIDED|95.0|-21.76|18.554|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||18.554|-21.76|0.876
71694287|NCT01656395|142903089|SUPERIORITY||Mean Difference (Final Values)|0.076||||0.682|TWO_SIDED|95.0|-0.288|0.44|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.440|-0.288|0.682
71694288|NCT01656395|142903089|SUPERIORITY||Mean Difference (Final Values)|-0.047||||0.807|TWO_SIDED|95.0|-0.422|0.329|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.329|-0.422|0.807
71694289|NCT01656395|142903089|SUPERIORITY||Mean Difference (Final Values)|0.165||||0.403|TWO_SIDED|95.0|-0.222|0.552|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.552|-0.222|0.403
71942430|NCT00864097|143406282|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.24|STANDARD_ERROR_OF_MEAN|0.08||0.002|TWO_SIDED|95.0|-0.4|-0.09|||ANCOVA|||LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.09|-0.40|0.002
71694290|NCT01656395|142903089|SUPERIORITY||Mean Difference (Final Values)|0.375||||0.051|TWO_SIDED|95.0|-0.001|0.751|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.751|-0.001|0.051
71694291|NCT01656395|142903089|SUPERIORITY||Mean Difference (Final Values)|0.319||||0.086|TWO_SIDED|95.0|-0.045|0.683|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.683|-0.045|0.086
71694292|NCT01656395|142903090|SUPERIORITY||Mean Difference (Final Values)|2.8||||0.7687|TWO_SIDED|95.0|-16.0|21.3|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).||21.3|-16.0|0.7687
71694293|NCT01656395|142903090|SUPERIORITY||Mean Difference (Final Values)|-6.6||||0.4943|TWO_SIDED|95.0|-24.9|12.2|||MN Method|||Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||12.2|-24.9|0.4943
71694294|NCT01656395|142903090|SUPERIORITY||Mean Difference (Final Values)|10.5||||0.3003|TWO_SIDED|95.0|-9.4|29.6|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||29.6|-9.4|0.3003
71694295|NCT01656395|142903090|SUPERIORITY||Mean Difference (Final Values)|17.5||||0.0774|TWO_SIDED|95.0|-1.9|35.7|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.7|-1.9|0.0774
71694296|NCT01656395|142903090|SUPERIORITY||Mean Difference (Final Values)|18.2||||0.0555|TWO_SIDED|95.0|-0.4|35.5|||MN method|||Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||35.5|-0.4|0.0555
71694297|NCT01656395|142903091|SUPERIORITY||Mean Difference (Final Values)|-0.104||||0.603|TWO_SIDED|95.0|-0.495|0.288|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.288|-0.495|0.603
71694298|NCT01656395|142903091|SUPERIORITY||Mean Difference (Final Values)|-0.032||||0.875|TWO_SIDED|95.0|-0.436|0.372|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.372|-0.436|0.875
71694299|NCT01656395|142903091|SUPERIORITY||Mean Difference (Final Values)|-0.151||||0.476|TWO_SIDED|95.0|-0.568|0.265|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.265|-0.568|0.476
71942431|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.01|STANDARD_ERROR_OF_MEAN|0.17||0.957|TWO_SIDED|95.0|-0.32|0.34|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.34|-0.32|0.957
71694300|NCT01656395|142903091|SUPERIORITY||Mean Difference (Final Values)|-0.362||||0.079|TWO_SIDED|95.0|-0.767|0.042|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.042|-0.767|0.079
71694301|NCT01656395|142903091|SUPERIORITY||Mean Difference (Final Values)|-0.227||||0.257|TWO_SIDED|95.0|-0.621|0.166|||cLDA model|||"Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.~cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast)."||0.166|-0.621|0.257
71694302|NCT01656395|142903092|SUPERIORITY||Mean Difference (Final Values)|3.1||||0.742|TWO_SIDED|95.0|-15.1|21.1|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||21.1|-15.1|0.742
71694303|NCT01656395|142903092|SUPERIORITY||Mean Difference (Final Values)|-3.4||||0.7248|TWO_SIDED|95.0|-22.1|15.4|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||15.4|-22.1|0.7248
71694304|NCT01656395|142903092|SUPERIORITY||Mean Difference (Final Values)|3.8||||0.6991|TWO_SIDED|95.0|-15.6|22.6|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||22.6|-15.6|0.6991
71694305|NCT01656395|142903092|SUPERIORITY||Mean Difference (Final Values)|8.1||||0.3934|TWO_SIDED|95.0|-10.6|26.2|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||26.2|-10.6|0.3934
71694306|NCT01656395|142903092|SUPERIORITY||Mean Difference (Final Values)|2.3||||0.8032|TWO_SIDED|95.0|-16.0|20.5|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).||20.5|-16.0|0.8032
71694307|NCT01656395|142903093|SUPERIORITY||Mean Difference (Final Values)|-0.075||||0.873|TWO_SIDED|95.0|-1.004|0.853|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).||0.853|-1.004|0.873
71694308|NCT01656395|142903093|SUPERIORITY||Mean Difference (Final Values)|-0.376||||0.437|TWO_SIDED|95.0|-1.326|0.575|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.575|-1.326|0.437
71942432|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.17||0.899|TWO_SIDED|95.0|-0.31|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.31|0.899
71694309|NCT01656395|142903093|SUPERIORITY||Mean Difference (Final Values)|-0.54||||0.27|TWO_SIDED|95.0|-1.504|0.423|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.423|-1.504|0.270
71694310|NCT01656395|142903093|SUPERIORITY||Mean Difference (Final Values)|0.079||||0.865|TWO_SIDED|95.0|-0.839|0.997|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.997|-0.839|0.865
71694311|NCT01656395|142903093|SUPERIORITY||Mean Difference (Final Values)|-0.309||||0.503|TWO_SIDED|95.0|-1.219|0.6|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).||0.600|-1.219|0.503
71694312|NCT00490035|142903184|SUPERIORITY_OR_OTHER_LEGACY||Percentage Reduction over Placebo|6.5|||=|0.261|TWO_SIDED|95.0|-5.2|16.9|||ANCOVA|||In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.||16.9|-5.2|=0.261
71694313|NCT03877744|142903207|NON_INFERIORITY|Non-inferiority margin of 2.5 was set prior to study initiation with a Type I error of 0.025.|Mean Difference (Final Values)|1.6873|STANDARD_ERROR_OF_MEAN|0.2558||0.0008|ONE_SIDED|97.5||2.1894|||Mixed Models Analysis|Controls technician,site,seat type;Techn. nested in site modeled as random effect;Model allowed heterogeneous variances across arms w Kenward-Roger df|Mixed model allowed the arms to have unequal variance estimates. Degrees of freedom estimated using Kenward-Rogers.|||2.1894||0.0008
71942433|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.39|STANDARD_ERROR_OF_MEAN|0.17||0.022|TWO_SIDED|95.0|0.06|0.72|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.72|0.06|0.022
71694314|NCT05209880|142903208|SUPERIORITY|||||||0.5835|||||||Wilcoxon (Mann-Whitney)|||||||0.5835
71694315|NCT04817332|142903224|SUPERIORITY||Odds Ratio (OR)|0.72||||0.008|TWO_SIDED|95.0|0.57|0.92|||Odds ratio Ordinal Logistic Regression|adjusted for the stratifying factors of age as a fixed effect and site using robust standard errors to account for clustering||||0.92|0.57|0.008
71942434|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.18||0.052|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.00|-0.70|0.052
71694316|NCT04817332|142903225|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.058|TWO_SIDED|95.0|0.76|1.0|||Regression, Cox|||||1.00|0.76|0.058
71694317|NCT04817332|142903228|SUPERIORITY||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.84|1.13||||||||1.13|0.84|
71694318|NCT04817332|142903230|SUPERIORITY||Rate ratio|0.93|||||TWO_SIDED|95.0|0.87|0.99||||||||0.99|0.87|
71694319|NCT04817332|142903231|SUPERIORITY||Rate ratio|1.13|||||TWO_SIDED|95.0|0.73|1.74||||||||1.74|0.73|
71694320|NCT04817332|142903232|SUPERIORITY||Rate ratio|0.84|||||TWO_SIDED|95.0|0.69|1.04||||||||1.04|0.69|
71694321|NCT04817332|142903233|SUPERIORITY||Rate ratio|1.68|||||TWO_SIDED|95.0|1.09|2.58||||||||2.58|1.09|
71694322|NCT04817332|142903234|SUPERIORITY||Rate ratio|1.03|||||TWO_SIDED|95.0|0.92|1.15||||||||1.15|0.92|
71694323|NCT04817332|142903235|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|1.06|1.88||||||||1.88|1.06|
71694324|NCT04817332|142903249|SUPERIORITY||Mean Difference (Final Values)|-67.0|||||TWO_SIDED|95.0|-102.0|-31.0||||||||-31|-102|
71694325|NCT04817332|142903253|SUPERIORITY||Mean Difference (Final Values)|0.003|||||TWO_SIDED|95.0|-0.06|0.066||||||||0.066|-0.06|
71694326|NCT04795466|142903260|SUPERIORITY||Least square mean difference|0.069|STANDARD_ERROR_OF_MEAN|0.1442||0.6386|TWO_SIDED|90.0|-0.178|0.316|||Mixed Models Analysis|||NTB Total z-score - day 171||0.316|-0.178|0.6386
71694327|NCT04795466|142903261|SUPERIORITY||Least squares mean difference|-0.002|STANDARD_ERROR_OF_MEAN|0.1739||0.9917|TWO_SIDED|90.0|-0.3|0.296|||Mixed Models Analysis|||Memory function - day 171||0.296|-0.300|0.9917
71694328|NCT04795466|142903262|SUPERIORITY||least squares mean difference|0.186|STANDARD_ERROR_OF_MEAN|0.1958||0.351|TWO_SIDED|90.0|-0.148|0.52|||Mixed Models Analysis|||Executive function- day 171||0.520|-0.148|0.3510
71694329|NCT04795466|142903263|SUPERIORITY||Repeated measures analysis|-0.49|STANDARD_ERROR_OF_MEAN|1.8||0.787|TWO_SIDED|90.0|-3.56|2.58|||Mixed Models Analysis|||DSST - day 171||2.58|-3.56|0.7870
71694330|NCT04577794|142903304|SUPERIORITY||Least square (LS) mean difference|0.0|STANDARD_ERROR_OF_MEAN|1.02||0.981|TWO_SIDED|90.0|-1.7|1.7|||ANCOVA|||An analysis of covariance (ANCOVA) was used with a multiple imputation method to handle missing values, with treatment as fixed effect and baseline score as covariate.||1.7|-1.7|0.981
71694331|NCT01107925|142903327|NON_INFERIORITY_OR_EQUIVALENCE|Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.|Estimate of the difference|-10.1||||0.526|TWO_SIDED|95.0|-23.4|0.2|||bootstrap (to determine 95% CI)||Estimate of the difference = \[median (low body weight) - Q3 (higher body weight)\]|||0.20|-23.40|0.526
71694332|NCT03311945|142903332|OTHER||||||||||||||||||This was a single-arm study without a comparator group; therefore, no formal hypothesis testing was conducted. The primary endpoint-therapeutic failure at 48 weeks-was analyzed descriptively. The proportion of participants experiencing therapeutic failure was calculated for both the intention-to-treat (ITT) and on-treatment (OT) populations. Exact binomial (Clopper-Pearson) 95% confidence intervals were used to estimate the failure rates.|||
71694333|NCT03839394|142903361|OTHER|||||||0.012|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.012
71694334|NCT03839394|142903362|OTHER|||||||0.05|||||||Z-test of Proportions|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.05
71694335|NCT03839394|142903363|OTHER|||||||0.75|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.750
71694336|NCT03839394|142903364|OTHER|||||||0.86|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.860
71694337|NCT03839394|142903365|OTHER|||||||0.76|||||||t-test, 2 sided|||This was a pilot study positioned to determine the effect size of a clinic-based intervention that has not been evaluated previously. Therefore, sample size was determined to be adequate to discern an effect size, but not powered to determine definitive statistical significance.||||0.760
71758605|NCT00836693|143019585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.7|STANDARD_ERROR_OF_MEAN|3.17|<|0.001|TWO_SIDED|95.0|5.5|18.0||p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||18.0|5.5|<0.001
71942435|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.05|-0.34|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.34|-1.05|<0.001
71942436|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.18||0.008|TWO_SIDED|95.0|-0.84|-0.13|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.13|-0.84|0.008
71942437|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.19||0.058|TWO_SIDED|95.0|-0.72|0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.72|0.058
71942438|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.05|-0.32|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.32|-1.05|<0.001
71942439|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.75|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.12|-0.38|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.38|-1.12|<0.001
71942440|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.53|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.91|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.91|0.007
71942441|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.18|-0.41|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.41|-1.18|<0.001
71942442|NCT00864097|143406283|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.66|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.05|-0.28|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.28|-1.05|<0.001
71942443|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.15||0.754|TWO_SIDED|95.0|-0.25|0.35|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.35|-0.25|0.754
71942444|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.06|STANDARD_ERROR_OF_MEAN|0.16||0.706|TWO_SIDED|95.0|-0.36|0.25|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.25|-0.36|0.706
71942445|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.17|STANDARD_ERROR_OF_MEAN|0.16||0.266|TWO_SIDED|95.0|-0.13|0.48|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.48|-0.13|0.266
71942446|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.18||0.195|TWO_SIDED|95.0|-0.58|0.12|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.12|-0.58|0.195
71942447|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.72|STANDARD_ERROR_OF_MEAN|0.18|<|0.001|TWO_SIDED|95.0|-1.07|-0.36|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.36|-1.07|<0.001
71942448|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.019|TWO_SIDED|95.0|-0.78|-0.07|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.78|0.019
71942449|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.28|STANDARD_ERROR_OF_MEAN|0.18||0.126|TWO_SIDED|95.0|-0.64|0.08|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.08|-0.64|0.126
71942450|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.1|-0.37|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.37|-1.10|<0.001
71942451|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|-0.98|-0.25|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-0.98|0.001
71942452|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.52|STANDARD_ERROR_OF_MEAN|0.19||0.007|TWO_SIDED|95.0|-0.9|-0.15|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.15|-0.90|0.007
71942453|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.82|STANDARD_ERROR_OF_MEAN|0.19|<|0.001|TWO_SIDED|95.0|-1.21|-0.44|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.44|-1.21|<0.001
71942454|NCT00864097|143406284|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.64|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED|95.0|-1.02|-0.25|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.25|-1.02|0.001
71694338|NCT00593450|142903401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-3.9|2.9||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.9|-3.9|0.16
71694339|NCT00593450|142903401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.16|TWO_SIDED|99.2|-4.1|2.4||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.4|-4.1|0.16
71694340|NCT00593450|142903401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.7|STANDARD_ERROR_OF_MEAN|1.5||0.16|TWO_SIDED|99.2|-4.7|1.3||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.3|-4.7|0.16
71694341|NCT00593450|142903401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.1|STANDARD_ERROR_OF_MEAN|1.9||0.16|TWO_SIDED|99.2|-5.7|1.6||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||1.6|-5.7|0.16
71694342|NCT00593450|142903401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-4.5|2.1||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||2.1|-4.5|0.16
71761227|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.2||0.1467|TWO_SIDED|95.0|-0.7|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.||0.1|-0.7|0.1467
71694343|NCT00593450|142903401|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study \[ETDRS\] visual-acuity chart)|Mean Difference (Net)|-2.6|STANDARD_ERROR_OF_MEAN|1.7||0.16|TWO_SIDED|99.2|-5.9|0.8||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.||0.8|-5.9|0.16
71694344|NCT00490919|142903431|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58|STANDARD_ERROR_OF_MEAN|0.225||0.0104|TWO_SIDED|95.0|-1.02|-0.14|||Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Double-blind analysis (comparison between BTDS and placebo TDS) at week 12 of the double-blind phase.|Missing average pain over the last 24 hours scores after treatment discontinuation were imputed using BOCF for adverse event-related withdrawals and LOCF for withdrawals due to other reasons.||-0.14|-1.02|.0104
71694345|NCT00490919|142903432|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.124|STANDARD_ERROR_OF_MEAN|0.0874||0.1586|TWO_SIDED|95.0|-0.296|0.048||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||Mean comparison from weeks 2-12 of the double-blind phase.|||0.048|-0.296|.1586
71694346|NCT00490919|142903433|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.4|STANDARD_ERROR_OF_MEAN|1.605||0.0062|TWO_SIDED|95.0|-7.55|-1.25||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Treatment comparison over Weeks 4, 8, and 12.|The primary comparison between groups was based on estimates and contrasts for the weeks 4, 8, and 12 mean values.||-1.25|-7.55|.0062
71694347|NCT02358031|142903434|SUPERIORITY||Hazard Ratio (HR)|0.93||||0.21211|TWO_SIDED|95.0|0.78|1.11||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.11|0.78|0.21211
71694348|NCT02358031|142903435|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.03697|TWO_SIDED|95.0|0.69|1.02||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.02|0.69|0.03697
71694349|NCT02358031|142903436|SUPERIORITY||Hazard Ratio (HR)|0.76||||0.02951|TWO_SIDED|95.0|0.58|1.01||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.01|0.58|0.02951
71694350|NCT02358031|142903437|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.00025|TWO_SIDED|95.0|0.6|0.87||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.87|0.60|0.00025
71694351|NCT02358031|142903438|SUPERIORITY||Hazard Ratio (HR)|0.65||||2e-05|TWO_SIDED|95.0|0.53|0.8||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.80|0.53|0.00002
71694352|NCT02358031|142903439|SUPERIORITY||Hazard Ratio (HR)|0.6||||0.00044|TWO_SIDED|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.82|0.45|0.00044
71694353|NCT02358031|142903440|SUPERIORITY||Hazard Ratio (HR)|1.29||||0.9983|TWO_SIDED|95.0|1.09|1.53||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.53|1.09|0.99830
71942455|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.09|STANDARD_ERROR_OF_MEAN|0.07||0.2|TWO_SIDED|95.0|-0.22|0.05|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.05|-0.22|0.200
71942456|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.07||0.754|TWO_SIDED|95.0|-0.15|0.11|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.11|-0.15|0.754
71942457|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|0.05|STANDARD_ERROR_OF_MEAN|0.07||0.449|TWO_SIDED|95.0|-0.08|0.18|||ANCOVA|||At Week 2: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.18|-0.08|0.449
71942458|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.07||0.062|TWO_SIDED|95.0|-0.27|0.01|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||0.01|-0.27|0.062
71694354|NCT02358031|142903441|SUPERIORITY||Hazard Ratio (HR)|1.13||||0.8958|TWO_SIDED|95.0|0.94|1.36||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||1.36|0.94|0.89580
71694355|NCT02358031|142903442|SUPERIORITY||Hazard Ratio (HR)|0.99||||0.46791|TWO_SIDED|95.0|0.76|1.29||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||1.29|0.76|0.46791
71942459|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.002|TWO_SIDED|95.0|-0.36|-0.08|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.08|-0.36|0.002
71942460|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.026|TWO_SIDED|95.0|-0.3|-0.02|||ANCOVA|||At Week 4: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.02|-0.30|0.026
71942461|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.032|TWO_SIDED|95.0|-0.31|-0.01|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.31|0.032
71942462|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.33|STANDARD_ERROR_OF_MEAN|0.07|<|0.001|TWO_SIDED|95.0|-0.48|-0.19|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.19|-0.48|<0.001
71942463|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.08|<|0.001|TWO_SIDED|95.0|-0.45|-0.16|||ANCOVA|||At Week 8: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.16|-0.45|<0.001
71942464|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.07||0.038|TWO_SIDED|95.0|-0.3|-0.01|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.01|-0.30|0.038
71942465|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.22|STANDARD_ERROR_OF_MEAN|0.07||0.003|TWO_SIDED|95.0|-0.37|-0.07|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.07|-0.37|0.003
71942466|NCT00864097|143406285|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-0.18|STANDARD_ERROR_OF_MEAN|0.08||0.016|TWO_SIDED|95.0|-0.33|-0.03|||ANCOVA|||At Week 12: LS means were estimated from the corresponding ANCOVA model. The ANCOVA model included treatment as main effect, baseline value, and index joint as covariates and study site as random effect.||-0.03|-0.33|0.016
71942467|NCT00849901|143406309|SUPERIORITY_OR_OTHER|||||||0.999||95.0|||||Mixed Models Analysis|||||||0.999
71942468|NCT00262223|143406321|SUPERIORITY_OR_OTHER_LEGACY||Incidence Rate Ratio|1.6||||0.34|TWO_SIDED|95.0|0.61|4.23|||Generalized Estimating Equations|Negative binomial models with log link were applied to the alcohol consumption measure.||Between group analyses were conducted of time-by-treatment interaction that included the four study time points (baseline, end-of-treatment, 6-mos and 12-mos).||4.23|0.61|0.34
71942469|NCT00262223|143406322|SUPERIORITY_OR_OTHER_LEGACY||Parameter Estimate|-16.15||||0.04|TWO_SIDED|95.0|-31.18|-1.13||A trend-level time-by-treatment interaction (p = .096) was probed for simple effects, which revealed a significantly greater reduction in CAPS scores at end-of-treatment in the SS+Sertraline group relative to the SS+Placebo group.|Generalized Estimating Equations|||Generalized estimating equations (GEE) were utilized to model PTSD outcomes. This method is an extension of the generalized linear model that handles correlated data arising from repeated measurements, requires no parametric distribution assumption, and provides robust inference with respect to misspecification of the within-subject correlation. A temporal within-subjects autoregressive \[AR(1)\] correlation matrix was used to model participants across timepoints.||-1.13|-31.18|0.04
71942470|NCT03828734|143406323|SUPERIORITY|||||||0.263|||||||ANOVA|||||||0.263
71942471|NCT03828734|143406324|SUPERIORITY||||||<|1e-06|||||||ANOVA|||||||<0.000001
71942472|NCT03828734|143406325|SUPERIORITY|||||||0.399|||||||ANOVA|||||||0.399
71694356|NCT02358031|142903443|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.01985|TWO_SIDED|95.0|0.7|0.99||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.99|0.70|0.01985
71694357|NCT02358031|142903444|SUPERIORITY||Hazard Ratio (HR)|0.74||||0.00133|TWO_SIDED|95.0|0.61|0.9||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.||0.90|0.61|0.00133
71694358|NCT02358031|142903445|SUPERIORITY||Hazard Ratio (HR)|0.58||||0.0001|TWO_SIDED|95.0|0.44|0.78||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG and HPV status.||0.78|0.44|0.00010
71694359|NCT02358031|142903452|OTHER||Difference in ORR Percentage|-0.8||||0.574|TWO_SIDED|95.0|-8.7|7.2||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||7.2|-8.7|0.5740
71694360|NCT02358031|142903453|OTHER||Difference in ORR Percentage|0.5||||0.4586|TWO_SIDED|95.0|-8.2|9.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||9.1|-8.2|0.4586
71694361|NCT02358031|142903454|OTHER||Difference in ORR Percentage|5.0||||0.2161|TWO_SIDED|95.0|-7.5|17.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||17.4|-7.5|0.2161
71694362|NCT02358031|142903455|OTHER||Difference in LS Means|0.4||||0.839|TWO_SIDED|95.0|-3.46|4.26||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||4.26|-3.46|0.839
71694363|NCT02358031|142903456|OTHER||Hazard Ratio (HR)|1.37||||0.9497|TWO_SIDED|95.0|0.94|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.94|0.9497
71694364|NCT02358031|142903457|OTHER||Hazard Ratio (HR)|1.37||||0.9476|TWO_SIDED|95.0|0.93|2.02||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.02|0.93|0.9476
71694365|NCT02358031|142903458|OTHER||Hazard Ratio (HR)|1.05||||0.5836|TWO_SIDED|95.0|0.69|1.59||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.59|0.69|0.5836
71694366|NCT02358031|142903465|OTHER||Difference in ORR Percentage|-19.0||||1|TWO_SIDED|95.0|-25.8|-12.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).||-12.1|-25.8|1.0000
71694367|NCT02358031|142903466|OTHER||Difference in ORR Percentage|-15.9||||1|TWO_SIDED|95.0|-23.4|-8.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||-8.3|-23.4|1.0000
71694368|NCT02358031|142903467|OTHER||Difference in ORR Percentage|-12.8||||0.9869|TWO_SIDED|95.0|-23.8|-1.5||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen \& Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).||-1.5|-23.8|0.9869
71761228|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.1|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||-0.4|-1.1|<0.0001
71942473|NCT01328093|143406336|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-3.2|STANDARD_ERROR_OF_MEAN|0.7|<|0.001||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||<0.001
71942474|NCT01328093|143406337|SUPERIORITY_OR_OTHER_LEGACY|||||||0.11||95.0||||P-value is for ≥7% increase.|Cochran-Mantel-Haenszel|||||||0.110
71942475|NCT01328093|143406337|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||P-value is for ≥7% decrease.|Cochran-Mantel-Haenszel|||||||<0.001
71942476|NCT01328093|143406338|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.04|STANDARD_ERROR_OF_MEAN|0.04||0.353||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.353
71942477|NCT01328093|143406339|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.03|STANDARD_ERROR_OF_MEAN|0.09||0.698||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.698
71942478|NCT01328093|143406340|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.01|STANDARD_ERROR_OF_MEAN|0.07||0.924||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.924
71942479|NCT01328093|143406341|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|3.55|STANDARD_ERROR_OF_MEAN|1.77||0.045||95.0||||P-value is for PANSS Total Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.045
71942480|NCT01328093|143406341|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.21|STANDARD_ERROR_OF_MEAN|0.56||0.032||95.0||||P-value is for PANSS Positive Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.032
71942481|NCT01328093|143406341|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.36|STANDARD_ERROR_OF_MEAN|0.54||0.509||95.0||||P-value is for PANSS Negative Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.509
71942482|NCT01328093|143406341|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|2.05|STANDARD_ERROR_OF_MEAN|1.0||0.04||95.0||||P-value is for PANSS General Psychopathology Score. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.040
71942483|NCT01328093|143406342|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|1.1|STANDARD_ERROR_OF_MEAN|2.1||0.601||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.601
71942484|NCT01328093|143406343|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.322||95.0||||P-value is for ER/Facility (Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.322
71942485|NCT01328093|143406343|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.04|STANDARD_ERROR_OF_MEAN|0.02||0.099||95.0||||P-value is for ER/Facility (Non-Psych) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.099
71942486|NCT01328093|143406343|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.07||0.787||95.0||||P-value is for Outpatient (Non-Psych or Dentist) visits. No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.787
71942487|NCT01328093|143406344|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.02|STANDARD_ERROR_OF_MEAN|0.12||0.892||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.892
71942488|NCT01328093|143406345|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.8|STANDARD_ERROR_OF_MEAN|1.6||0.63||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.630
71942489|NCT01328093|143406346|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|-0.5|STANDARD_ERROR_OF_MEAN|1.2||0.679||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.679
71942490|NCT01328093|143406347|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.17|STANDARD_ERROR_OF_MEAN|0.09||0.055||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.055
71942491|NCT01328093|143406348|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Differences|0.15|STANDARD_ERROR_OF_MEAN|1.11||0.891||95.0||||No adjustments for multiple comparisons were made. The treatment comparison was evaluated at a 2-sided significance level of 0.05.|Type III Tests|||||||0.891
71942492|NCT01328093|143406350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.064||95.0||||P-value is for Treatment-Emergent Suicidal Ideation.|Fisher Exact|||||||0.064
71942493|NCT01328093|143406350|SUPERIORITY_OR_OTHER_LEGACY|||||||0.205||95.0||||P-value is for Treatment-Emergent Suicidal Behavior.|Fisher Exact|||||||0.205
71942494|NCT05150964|143406355|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The hearing aid fitting prescription will have no effect on the speech reception thresholds."||||<0.05
71942495|NCT05150964|143406355|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05, Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (NAL/National Acoustic Laboratory or DSL/Desired Sensation Level) and ASG (Adaptive Situational Gain) setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor.~Null hypothesis: The ASG setting will have no effect on the speech reception threshold."||||>0.05
71942496|NCT05150964|143406356|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The ASG setting will have no effect on the Word Recognition Scores."||||<0.05
71942497|NCT05150964|143406356|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: The presentation level will have no effect on the Word Recognition Scores."||||<0.05
71942498|NCT05150964|143406356|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null Hypothesis: Hearing aid prescription will have no effect on the Word Recognition Scores."||||<0.05
71942499|NCT05150964|143406357|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on multi-word recognition scores."||||<0.05
71942500|NCT05150964|143406357|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on multi-word recognition scores."||||>0.05
71942501|NCT05150964|143406357|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on multi-word recognition scores."||||>0.05
71942502|NCT05150964|143406358|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Nonword Detection scores."||||<0.05
71942503|NCT05150964|143406358|OTHER||||||<|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescription will have no effect on Nonword Detection scores."||||<0.05
71942504|NCT05150964|143406358|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Nonword Detection scores."||||>0.05
71942505|NCT05150964|143406359|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: The ASG setting will have no effect on Rapid Word Learning scores."||||>0.05
71942506|NCT05150964|143406359|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Presentation level will have no effect on Rapid Word Learning scores."||||>0.05
71942507|NCT05150964|143406359|OTHER||||||>|0.05||||||Significance was indicated by p \<. 05 and Cohen's d was calculated to indicate effect size.|Mixed Models Analysis|||"A Linear Mixed Model Analysis was performed. The hearing aid prescription (DSL, NAL) and ASG setting (on, off) were entered as fixed factors while the individual participants were entered as a random factor. An additional fixed factor of presentation level (40, 70 dB SPL) was added to the analyses.~Null hypothesis: Hearing aid prescripton will have no effect on Rapid Word Learning scores."||||>0.05
71942508|NCT00832377|143406361|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 peak IOP vs. baseline|paired t-test|||||||<0.0001
71942509|NCT00832377|143406362|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 trough IOP vs. baseline|paired t-test|||||||<0.0001
71942510|NCT00832377|143406363|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||Week 12 8-HR IOP vs. baseline|paired t-test|||||||<0.0001
71942511|NCT03682900|143406365|SUPERIORITY||||||=|0||||||A one tailed test was used, as the intervention is expected to be superior than the control group. The criterion for significance was p \<. 05.|Mixed Models Analysis|There were no adjustments made for multiple comparisons.||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||= .000
71942512|NCT03682900|143406366|SUPERIORITY||||||=|0||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition||||= .000
71942513|NCT03682900|143406367|SUPERIORITY||||||=|0.044||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.044
71942514|NCT03682900|143406368|SUPERIORITY||||||=|0.033||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for significance is p\<.05.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||=.033
71942515|NCT03682900|143406369|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942516|NCT03682900|143406370|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942517|NCT03682900|143406371|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942518|NCT03682900|143406372|SUPERIORITY||||||<|0.001||||||"The a prior threshold for statistical significance is set at p\<.05; one tailed test, as the intervention is expected to be superior than the control group.~The p-value is not adjusted for multiple comparisons."|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942519|NCT03682900|143406373|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942520|NCT03682900|143406374|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942521|NCT03682900|143406375|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942522|NCT03682900|143406376|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71942523|NCT03682900|143406377|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a gneral linear mixed model with students nested within schools and schools nested within condition.||||<.001
71694369|NCT02358031|142903468|OTHER||Difference in LS Means|0.24||||0.893|TWO_SIDED|95.0|-3.34|3.82||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG \[0 vs. 1\], HPV status \[Positive vs. Negative\] and PD-L1 TPS status \[Strongly Positive, Not Strongly Positive\]) as covariates.||3.82|-3.34|0.893
71694370|NCT02358031|142903469|OTHER||Hazard Ratio (HR)|1.38||||0.953|TWO_SIDED|95.0|0.95|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||2.00|0.95|0.9530
71694371|NCT02358031|142903470|OTHER||Hazard Ratio (HR)|0.8||||0.1501|TWO_SIDED|95.0|0.53|1.21||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.21|0.53|0.1501
71694372|NCT02358031|142903471|OTHER||Hazard Ratio (HR)|1.26||||0.8751|TWO_SIDED|95.0|0.85|1.88||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H\&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).||1.88|0.85|0.8751
71694373|NCT03101150|142903477|OTHER|A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.|Risk Ratio (RR)|0.163|||<|0.05|TWO_SIDED|95.0|0.02|1.32|||Chi-squared|||Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.||1.32|0.02|<0.05
71694374|NCT03101150|142903478|OTHER||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71694375|NCT03101150|142903479|OTHER||Risk Ratio (RR)|0.43|||<|0.02|TWO_SIDED|95.0|0.19|0.94|||Chi-squared|||||0.94|0.19|<0.02
71942524|NCT03682900|143406378|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlayzed using a general linear mixed model with students nested within schools and schools within condition.||||<.001
71694376|NCT03163446|142903482|OTHER|Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|10.4||||0.3137|TWO_SIDED|90.0|-6.35|27.19|||Fisher Exact|||||27.19|-6.35|0.3137
71694377|NCT03163446|142903492|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|42.8||||0.0101|TWO_SIDED|90.0|14.3|71.4|||Fisher Exact|||||71.4|14.3|0.0101
71694378|NCT03163446|142903493|OTHER|P value was ad hoc. Descriptive statistics were performed.||||||0.0646|||||||Fisher Exact||||Descriptive statistics were performed.|||0.0646
71694379|NCT03163446|142903495|OTHER|P-value was ad hoc. Statistics considered descriptive as study designed to provide proof of concept and initial assessment of efficacy; not considered confirmatory.|Risk Difference (RD)|-21.3||||0.0556|TWO_SIDED|90.0|-45.1|2.5|||Fisher Exact|||||2.5|-45.1|0.0556
71694380|NCT01228591|142903513|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05logMAR.|Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0044|0.0187|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0187|-0.0044|
71694381|NCT01228591|142903513|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.003|STANDARD_ERROR_OF_MEAN|0.0059|||TWO_SIDED|95.0|-0.0086|0.0146|||Mixed Models Analysis||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be \<= to the control lens (Acuvue Advance)."||0.0146|-0.0086|
71694382|NCT01228591|142903514|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.016|STANDARD_ERROR_OF_MEAN|0.0061|||TWO_SIDED|95.0|0.0041|0.0282|||Mixed Models Analysis||Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).|"For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.0282|0.0041|
71942525|NCT03682900|143406379|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. Apriori, a p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed uisng a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71694383|NCT01228591|142903514|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.021|STANDARD_ERROR_OF_MEAN|0.006|||TWO_SIDED|95.0|0.009|0.3305|||Mixed Models Analysis||Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).|"For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be \<= to the control lens (Advance)."||0.3305|0.0090|
71694384|NCT01298700|142903566|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.7||||0.148|TWO_SIDED|95.0|-11.0|1.9||P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).|Cochran-Mantel-Haenszel||bimatoprost 0.01% ophthalmic solution - bimatoprost 0.03% ophthalmic solution|||1.9|-11|0.148
71694385|NCT00129441|142903568|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||ANOVA|||||||0.16
71694386|NCT00129441|142903569|SUPERIORITY_OR_OTHER|||||||0.162||95.0|||||ANOVA|||||||0.162
71694387|NCT00129441|142903570|SUPERIORITY_OR_OTHER|||||||0.12||95.0|||||ANOVA|||||||0.12
71694388|NCT00129441|142903571|SUPERIORITY_OR_OTHER|||||||0.05||95.0|||||ANOVA|||||||0.05
71694389|NCT00129441|142903572|SUPERIORITY_OR_OTHER|||||||0.249||95.0|||||ANOVA|||||||0.249
71694390|NCT00129441|142903573|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANOVA|||At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.||||0.01
71694391|NCT00129441|142903574|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71694392|NCT00129441|142903575|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||||||<0.05
71694393|NCT01001429|142903576|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Regression, Logistic|||||||0.04
71694394|NCT01001429|142903576|SUPERIORITY_OR_OTHER|||||||0.68|TWO_SIDED||||||Regression, Linear|||UMSS scores with subjects propofol vs. Dexmetomidine group||||0.68
71694395|NCT01053741|142903595|OTHER||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there is no difference in epithelial surface disruption when comparing the two interventions. Power calculation was based on identifying a median difference in histology grade of 0.83, using a two-sided alpha of 0.05 with 90% power in 10 subjects.||||<0.05
71694396|NCT03143257|142903617|SUPERIORITY||Mean Difference (Net)|38.0|STANDARD_DEVIATION|16.1|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71694397|NCT03143257|142903617|SUPERIORITY||Mean Difference (Net)|43.5|STANDARD_DEVIATION|20.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.0001
71694398|NCT03143257|142903617|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_DEVIATION|5.0|<|0.0001|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||< 0.0001
71694399|NCT03143257|142903620|SUPERIORITY||Overall Benefit Score|-15.0|STANDARD_DEVIATION|18.5|||TWO_SIDED||||||||The overall benefit can be determined by subtracting the aided and unaided scores of Ease of Communication, Reverberation, Background Noise \& Aversiveness. A negative score in overall benefit indicates a positive benefit to the subject.|||||
71694400|NCT00619827|142903621|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.97||||0.0003|TWO_SIDED|95.0|-2.99|-0.94|||ANCOVA|||||-0.94|-2.99|0.0003
71694401|NCT00104052|142903622|SUPERIORITY_OR_OTHER||Normal approximation to the binomial|0.654||||||95.0|0.564|0.744||||||||0.744|0.564|
71694402|NCT00917124|142903651|SUPERIORITY_OR_OTHER|||||||0.002|||||||Chi-squared, Corrected|||"Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.~Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group."||||0.002
71694403|NCT04428385|142903659|SUPERIORITY||Risk Ratio (RR)|0.85|||||TWO_SIDED|95.0|0.34|2.16||||||||2.16|0.34|
71694404|NCT04428385|142903660|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.47|1.78||||||||1.78|0.47|
71694405|NCT04428385|142903661|SUPERIORITY||Risk Ratio (RR)|0.76|||||TWO_SIDED|95.0|0.36|1.62||||||||1.62|0.36|
71694406|NCT04428385|142903662|SUPERIORITY||Risk Ratio (RR)|0.67|||||TWO_SIDED|95.0|0.33|1.33||||||||1.33|0.33|
71694407|NCT04428385|142903663|SUPERIORITY||Risk Ratio (RR)|1.09|||||TWO_SIDED|95.0|0.62|1.9||||||||1.90|0.62|
71694408|NCT02219685|142903804|SUPERIORITY_OR_OTHER|||||||0.58||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.58
71694409|NCT02219685|142903804|SUPERIORITY_OR_OTHER|||||||0.48||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.48
71694410|NCT02219685|142903804|SUPERIORITY_OR_OTHER|||||||0.96||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.96
71694411|NCT02219685|142903805|SUPERIORITY_OR_OTHER|||||||0.54||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.54
71694412|NCT02219685|142903805|SUPERIORITY_OR_OTHER|||||||0.57||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.57
71694413|NCT02219685|142903805|SUPERIORITY_OR_OTHER|||||||0.63||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.63
71694414|NCT02219685|142903806|SUPERIORITY_OR_OTHER|||||||0.7||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.70
71694415|NCT02219685|142903806|SUPERIORITY_OR_OTHER|||||||0.21||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.21
71694416|NCT02219685|142903806|SUPERIORITY_OR_OTHER|||||||0.59||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided|||||||0.59
71694417|NCT02219685|142903807|SUPERIORITY_OR_OTHER|||||||0.0795||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.0795
71694418|NCT02219685|142903808|SUPERIORITY_OR_OTHER|||||||0.7007||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.7007
71694419|NCT02219685|142903809|SUPERIORITY_OR_OTHER|||||||0.2677||||||The p-value was ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.2677
71694420|NCT02219685|142903810|SUPERIORITY_OR_OTHER|||||||0.987||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.9870
71694421|NCT02219685|142903811|SUPERIORITY_OR_OTHER|||||||0.3388||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA|||||||0.3388
71694422|NCT02389959|142903833|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.11||||0.111|TWO_SIDED|95.0|-2.47|0.26|||Regression, Linear|||Analysis between groups at month 1.||0.26|-2.47|0.111
71694423|NCT02389959|142903833|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-1.26||||0.131|TWO_SIDED|95.0|-2.9|0.38|||Regression, Linear|||Analysis between groups at month 2.||0.38|-2.9|0.131
71694424|NCT02389959|142903833|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.85||||0.332|TWO_SIDED|95.0|-2.57|0.88|||Regression, Linear|||Analysis between groups at month 4.||0.88|-2.57|0.332
71694425|NCT02389959|142903833|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of ESS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-0.48||||0.597|TWO_SIDED|95.0|-2.25|1.3|||Regression, Linear|||Analysis between groups at month 6.||1.3|-2.25|0.597
71942526|NCT03682900|143406380|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is a priori considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear model with students nested within schools and schools nested within condition.||||<.001
71942527|NCT03682900|143406381|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71694426|NCT02389959|142903834|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|2.85||||0.191|TWO_SIDED|95.0|-1.44|7.13|||Regression, Linear|||Analysis between groups at month 1.||7.13|-1.44|0.191
71694427|NCT02389959|142903834|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.29||||0.914|TWO_SIDED|95.0|-5.02|5.61|||Regression, Linear|||Analysis between groups at month 2||5.61|-5.02|0.914
71694428|NCT02389959|142903834|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|1.55||||0.592|TWO_SIDED|95.0|-4.17|7.28|||Regression, Linear|||Analysis between groups at month 4.||7.28|-4.17|0.592
71694429|NCT02389959|142903834|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of PCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|3.1||||0.31|TWO_SIDED|95.0|-2.92|9.12|||Regression, Linear|||Analysis between groups at month 6||9.12|-2.92|0.31
71942528|NCT03682900|143406382|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71694430|NCT02389959|142903835|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-2.63||||0.366|TWO_SIDED|95.0|-8.38|3.11|||Regression, Linear|||Analysis between groups at month 1.||3.11|-8.38|0.366
71694431|NCT02389959|142903835|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|0.82||||0.816|TWO_SIDED|95.0|-6.12|7.76|||Regression, Linear|||Analysis between groups at month 2||7.76|-6.12|0.816
71694432|NCT02389959|142903835|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-4.3||||0.247|TWO_SIDED|95.0|-11.61|3.02|||Regression, Linear|||Analysis between groups at month 4.||3.02|-11.61|0.247
71694433|NCT02389959|142903835|OTHER|Linear regression model with repeated measures, controlling for patient's demographic factors, smoking status, and baseline level of MCS. The analysis is weighted by inverse probability treatment weight (IPTW).|Mean Difference (Net)|-8.18||||0.035|TWO_SIDED|95.0|-15.76|-0.6|||Regression, Linear|||Analysis between groups at month 6||-0.6|-15.76|0.035
71694434|NCT02389959|142903836|OTHER|||||||0.03|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at baseline.||||0.030
71694435|NCT02389959|142903836|OTHER|||||||0.719|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 2.||||0.719
71694436|NCT02389959|142903836|OTHER|||||||0.467|||||||Wilcoxon rank sum test, 2-sided|||Analysis of intergroup difference at month 6.||||0.467
71694437|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.855|||||TWO_SIDED|90.0|0.799|0.914|||ANCOVA||AUC (0-inf) comparison|||0.914|0.799|
71694438|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.677|||||TWO_SIDED|90.0|0.635|0.721|||ANCOVA||AUC (0-inf) comparision|||0.721|0.635|
71694439|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.637|||||TWO_SIDED|90.0|0.594|0.682|||ANCOVA||AUC (0-inf) comparision|||0.682|0.594|
71694440|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.803|||||TWO_SIDED|90.0|0.747|0.864|||ANCOVA||AUC (0-24) comparision|||0.864|0.747|
71694441|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.608|||||TWO_SIDED|90.0|0.566|0.655|||ANOVA||AUC (0-24) comparision|||0.655|0.566|
71694442|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.557|||||TWO_SIDED|90.0|0.518|0.599|||ANCOVA||AUC (0-24) comparision|||0.599|0.518|
71942529|NCT03682900|143406383|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were anlyzed using a general linear model mixed model with students nested within schools and schools nested within condition.||||<.001
71942530|NCT03682900|143406384|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71694443|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.819|||||TWO_SIDED|90.0|0.766|0.876|||ANCOVA||AUC (0-t) comparision|||0.876|0.766|
71694444|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.636|||||TWO_SIDED|90.0|0.595|0.68|||ANCOVA||AUC (0-t) comparision|||0.680|0.595|
71694445|NCT02634073|142903866|SUPERIORITY_OR_OTHER||Ratio|0.585|||||TWO_SIDED|90.0|0.548|0.626|||ANCOVA||AUC (0-t) comparision|||0.626|0.548|
71694446|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|0.993|||||TWO_SIDED|90.0|0.916|1.08|||ANCOVA||C24 comparison|||1.08|0.916|
71694447|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|1.12|||||TWO_SIDED|90.0|1.03|1.21|||ANCOVA||C24 comparision|||1.21|1.03|
71694448|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|1.09|||||TWO_SIDED|90.0|1.0|1.18|||ANCOVA||C24 comparision|||1.18|1.000|
71694449|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|1.33|||||TWO_SIDED|90.0|1.13|1.56|||ANCOVA||Ct comparision|||1.56|1.13|
71694450|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|1.46|||||TWO_SIDED|90.0|1.25|1.71|||ANCOVA||Ct comparision|||1.71|1.25|
71694451|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|1.39|||||TWO_SIDED|90.0|1.18|1.63|||ANCOVA||Ct comparision|||1.63|1.18|
71694452|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|0.724|||||TWO_SIDED|90.0|0.657|0.798|||ANCOVA||Cmax comparision|||0.798|0.657|
71694453|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|0.479|||||TWO_SIDED|90.0|0.434|0.527|||ANCOVA||Cmax comparision|||0.527|0.434|
71694454|NCT02634073|142903867|SUPERIORITY_OR_OTHER||Ratio|0.454|||||TWO_SIDED|90.0|0.412|0.5|||ANCOVA||Cmax comparision|||0.500|0.412|
71694455|NCT02634073|142903868|SUPERIORITY_OR_OTHER||Ratio|1.37|||||TWO_SIDED|90.0|1.11|1.69|||ANCOVA|||||1.69|1.11|
71694456|NCT02634073|142903868|SUPERIORITY_OR_OTHER||Ratio|1.53|||||TWO_SIDED|90.0|1.25|1.88|||ANCOVA|||||1.88|1.25|
71694457|NCT02634073|142903868|SUPERIORITY_OR_OTHER||Ratio|1.29|||||TWO_SIDED|90.0|1.04|1.61|||ANCOVA|||||1.61|1.04|
71694458|NCT02634073|142903869|SUPERIORITY_OR_OTHER||Ratio|1.17|||||TWO_SIDED|90.0|1.094|1.251|||ANCOVA|||||1.251|1.094|
71694459|NCT02634073|142903869|SUPERIORITY_OR_OTHER||Ratio|1.478|||||TWO_SIDED|90.0|1.386|1.576|||ANCOVA|||||1.576|1.386|
71694460|NCT02634073|142903869|SUPERIORITY_OR_OTHER||Ratio|1.571|||||TWO_SIDED|90.0|1.466|1.684|||ANCOVA|||||1.684|1.466|
71694461|NCT02256696|142903899|SUPERIORITY||Hazard Ratio (HR)|1.41||||0.1|TWO_SIDED|95.0|0.93|2.12|||Regression, Cox|adjusted for age and sex at birth.||modified intention to treat (mITT) analysis||2.12|0.93|0.10
71694462|NCT02256696|142903899|SUPERIORITY||Hazard Ratio (HR)|1.89||||0.003|TWO_SIDED|95.0|1.24|2.87|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.87|1.24|0.003
71694463|NCT02256696|142903899|SUPERIORITY||Hazard Ratio (HR)|1.43||||0.09|TWO_SIDED|95.0|0.95|2.15|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.15|0.95|0.09
71694464|NCT02256696|142903899|SUPERIORITY||Hazard Ratio (HR)|1.87||||0.005|TWO_SIDED|95.0|1.21|2.89|||Regression, Cox|adjusted for age and sex at birth||per protocol||2.89|1.21|0.005
71694465|NCT02256696|142903902|SUPERIORITY||Hazard Ratio (HR)|1.61||||0.02|TWO_SIDED|95.0|1.07|2.44|||Regression, Cox|adjusted for age and sex at birth.||mITT analysis||2.44|1.07|0.02
71694466|NCT02256696|142903902|SUPERIORITY||Hazard Ratio (HR)|1.8||||0.006|TWO_SIDED|95.0|1.18|2.75|||Regression, Cox|adjusted for age and sex at birth||mITT analysis||2.75|1.18|0.006
71694467|NCT02256696|142903902|SUPERIORITY||Hazard Ratio (HR)|1.6||||0.03|TWO_SIDED|95.0|1.05|2.42|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.42|1.05|0.03
71694468|NCT02256696|142903902|SUPERIORITY||Hazard Ratio (HR)|1.84||||0.007|TWO_SIDED|95.0|1.18|2.85|||Regression, Cox|adjusted for age and sex at birth||per protocol analysis||2.85|1.18|0.007
71694469|NCT01431339|142903915|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|-1.5||||||95.0|-7.4|4.6|||||Confidence intervals were adjusted for fever at baseline|||4.6|-7.4|
71694470|NCT02227784|142903950|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.48|||<|0.001|TWO_SIDED|95.0|-44.4|-23.3|||ANCOVA|||||-23.3|-44.4|<0.001
71694471|NCT02227784|142903950|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-27.24|||<|0.001|TWO_SIDED|95.0|-36.6|-18.5|||ANCOVA|||||-18.5|-36.6|<0.001
71942531|NCT03682900|143406385|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schols and schools nested within condition.||||<.001
71942532|NCT03682900|143406386|SUPERIORITY||||||<|0.001||||||All probabilities for secondary outcomes were listed as p = .000 within the analysis program. A p value of \< .05 is considered significant. All statistical tests are one-tailed. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|||Data were analyzed using a general linear mixed model with students nested within schools and schools nested within condition.||||<.001
71694472|NCT02227784|142903950|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-6.14||||0.045|TWO_SIDED|95.0|-12.2|-0.22|||ANCOVA|||||-0.22|-12.2|0.045
71942533|NCT01941030|143406387|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.022|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty reduction of calcium out of lumen gain.||||0.0220
71942534|NCT01941030|143406388|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6228|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-balloon angioplasty minimum lumen area stenosis.||||0.6228
71694473|NCT02227784|142903951|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|125.28|||<|0.001|TWO_SIDED|95.0|117.1|133.6|||Mixed Models Analysis|||||133.6|117.1|<0.001
71694474|NCT02227784|142903951|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|131.48|||<|0.001|TWO_SIDED|95.0|123.5|139.5|||Mixed Models Analysis|||||139.5|123.5|<0.001
71694475|NCT02227784|142903951|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|127.57|||<|0.001|TWO_SIDED|95.0|120.1|135.0|||Mixed Models Analysis|||||135.0|120.1|<0.001
71694476|NCT02227784|142903952|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|46.35|||<|0.001|TWO_SIDED|95.0|40.79|51.98|||ANCOVA|||||51.98|40.79|<0.001
71694477|NCT02227784|142903952|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|52.22|||<|0.001|TWO_SIDED|95.0|47.12|57.33|||ANCOVA|||||57.33|47.12|<0.001
71694478|NCT02227784|142903952|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|48.44|||<|0.001|TWO_SIDED|95.0|43.82|52.86|||ANCOVA|||||52.86|43.82|<0.001
71694479|NCT02227784|142903953|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-26.47|||<|0.001|TWO_SIDED|95.0|-33.4|-20.0|||Mixed Models Analysis|||||-20.0|-33.4|<0.001
71694480|NCT02227784|142903953|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-22.02|||<|0.001|TWO_SIDED|95.0|-28.4|-15.9|||Mixed Models Analysis|||||-15.9|-28.4|<0.001
71694481|NCT02227784|142903953|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-7.05|||<|0.001|TWO_SIDED|95.0|-11.5|-2.68|||Mixed Models Analysis|||||-2.68|-11.5|<0.001
71694482|NCT02227784|142903954|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-23.16|||<|0.001|TWO_SIDED|95.0|-30.0|-16.5|||ANCOVA|||||-16.5|-30.00|<0.001
71694483|NCT02227784|142903954|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-16.42|||<|0.001|TWO_SIDED|95.0|-22.3|-10.6|||ANCOVA|||||-10.6|-22.3|<0.001
71942535|NCT01941030|143406389|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.4528|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty plaque area.||||0.4528
71942536|NCT01941030|143406390|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.3573|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty dense calcium area.||||0.3573
71942537|NCT01941030|143406391|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6073|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty necrotic core area.||||0.6073
71694484|NCT02227784|142903954|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-4.11||||0.062|TWO_SIDED|95.0|-8.47|0.15|||ANCOVA|||||0.15|-8.47|0.062
71694485|NCT02227784|142903955|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|38.05|||<|0.001|TWO_SIDED|95.0|30.17|45.88|||ANCOVA|||||45.88|30.17|<0.001
71694486|NCT02227784|142903955|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|42.12|||<|0.001|TWO_SIDED|95.0|34.29|49.76|||ANCOVA|||||49.76|34.29|<0.001
71694487|NCT02227784|142903955|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|39.64|||<|0.001|TWO_SIDED|95.0|33.2|46.08|||ANCOVA|||||46.08|33.20|<0.001
71694488|NCT02227784|142903956|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-33.18|||<|0.001|TWO_SIDED|95.0|-44.9|-22.3|||ANCOVA|||||-22.3|-44.9|<0.001
71694489|NCT02227784|142903956|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-32.63|||<|0.001|TWO_SIDED|95.0|-44.0|-21.8|||ANCOVA|||||-21.8|-44.0|<0.001
71694490|NCT02227784|142903956|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-42.15|||<|0.001|TWO_SIDED|95.0|-50.9|-33.4|||ANCOVA|||||-33.4|-50.9|<0.001
71694491|NCT02699996|142903972|SUPERIORITY||Mean Difference (Final Values)|0.52|||<|0.01|TWO_SIDED|95.0|0.17|0.86|||t-test, 2 sided|df = 14||RTQ-Survivor Adolescent Responsibility Score||0.86|0.17|<.01
71694492|NCT02699996|142903972|SUPERIORITY||Mean Difference (Final Values)|0.67|||<|0.01|TWO_SIDED|95.0|0.27|1.07|||t-test, 2 sided|df=14||RTQ-Overall Readiness Score||1.07|0.27|<.01
71694493|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.23||||0.02|TWO_SIDED|95.0|0.05|0.42|||t-test, 2 sided|df=14||TRI-total Score||0.42|0.05|0.02
71694494|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.49|||<|0.01|TWO_SIDED|95.0|0.26|0.73|||t-test, 2 sided|df=14||TRI Knowledge score||0.73|0.26|<.01
71694495|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.053|TWO_SIDED|95.0|-0.0044|0.6|||t-test, 2 sided|df=14||TRI Skills/Self-Efficacy Score||0.60|-0.0044|0.053
71694496|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.13||||0.03|TWO_SIDED|95.0|0.02|0.24|||t-test, 2 sided|df=14||TRI Beliefs/Expectations score||0.24|0.02|0.03
71694497|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.01|TWO_SIDED|95.0|0.11|0.69|||t-test, 2 sided|df=14||TRI Goals/Motivation score||0.69|0.11|<.01
71694498|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.61|TWO_SIDED|95.0|-0.16|0.26|||t-test, 2 sided|df=14||Relationship/Communication Score||0.26|-0.16|0.61
71694499|NCT02699996|142903973|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.65|TWO_SIDED|95.0|-0.37|0.57|||t-test, 2 sided|df=14||TRI Psychosocial/Emotional Score||0.57|-0.37|0.65
71694500|NCT02699996|142903974|SUPERIORITY||Median Difference (Final Values)|-1.64||||0.56|TWO_SIDED|95.0|-7.62|4.34|||t-test, 2 sided|df = 13||||4.34|-7.62|.56
71694501|NCT02699996|142903975|SUPERIORITY||Mean Difference (Final Values)|-1.74||||0.42|TWO_SIDED|95.0|-6.23|2.75|||t-test, 2 sided|df = 14||||2.75|-6.23|.42
71694502|NCT02699996|142903976|SUPERIORITY||Mean Difference (Final Values)|-0.28||||0.26|TWO_SIDED|95.0|-0.8|0.23|||t-test, 2 sided|df = 14||||0.23|-0.80|.26
71942538|NCT01941030|143406392|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.2149|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrous plaque area.||||0.2149
71942539|NCT01941030|143406393|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.0579|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrofatty plaque area.||||0.0579
71942540|NCT01941030|143406394|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.076|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 600 mcg adenosine.||||0.076
71942541|NCT01941030|143406394|OTHER|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.205|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 1200 mcg adenosine.||||0.205
71942542|NCT02268500|143406457|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
71942543|NCT02268500|143406458|SUPERIORITY|||||||0.43|||||||Chi-squared|||||||0.43
71694503|NCT02699996|142903977|SUPERIORITY||Mean Difference (Final Values)|0.28||||0.03|TWO_SIDED|95.0|0.03|0.52|||t-test, 2 sided|df = 14||||0.52|0.03|.03
71694504|NCT02699996|142903978|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.2|TWO_SIDED|95.0|-0.12|0.52|||t-test, 2 sided|df = 14||Body Health Subscale||0.52|-0.12|.20
71694505|NCT02699996|142903978|SUPERIORITY||Mean Difference (Final Values)|-0.13||||0.4|TWO_SIDED|95.0|-0.46|0.2|||t-test, 2 sided|df = 14||Personal Growth Subscale||0.20|-0.46|.40
71694506|NCT02699996|142903978|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.29|TWO_SIDED|95.0|-0.09|0.29|||t-test, 2 sided|df = 14||Memory Subscale||0.29|-0.09|.29
71694507|NCT02699996|142903979|SUPERIORITY||Mean Difference (Final Values)|-0.19||||0.08|TWO_SIDED|95.0|-0.4|0.03|||t-test, 2 sided|df = 14||||0.03|-0.40|.08
71694508|NCT01095835|142903985|SUPERIORITY_OR_OTHER|||||||0.08|||||||Chi-squared|||||||0.08
71694509|NCT04006145|142904033|SUPERIORITY||LS-Means Difference|-0.4|STANDARD_ERROR_OF_MEAN|0.184||0.029|TWO_SIDED|95.0|-0.76|-0.04|||ANCOVA|||Change from baseline in serum LDL-C at Week 16 was analyzed using ANCOVA after the missing data imputation, with treatment group as a factor, baseline serum LDL-C, baseline LDL-C-by-treatment interaction values, and baseline lipid-lowering medications (Yes or No) as covariates. Missing data for serum LDL-C was imputed through multiple imputation method as described in the statistical analysis plan (SAP).||-0.04|-0.76|0.029
71694510|NCT01249417|142904057|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.38||||0.0029|TWO_SIDED|95.0|-0.64|-0.13|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.13|-0.64|0.0029
71942544|NCT02268500|143406459|SUPERIORITY|||||||0.03|||||||Chi-squared|||||||0.03
71942545|NCT02268500|143406460|SUPERIORITY|||||||0.76|||||||Chi-squared|||||||0.76
71942546|NCT02268500|143406461|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||0.01
71694511|NCT01249417|142904057|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|-0.49||||0.0002|TWO_SIDED|95.0|-0.75|-0.23|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.||-0.23|-0.75|0.0002
71694512|NCT01249417|142904058|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.82|||<|0.0001|TWO_SIDED|95.0|0.5|1.14|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.14|0.50|<0.0001
71694513|NCT01249417|142904058|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|0.77|||<|0.0001|TWO_SIDED|95.0|0.45|1.1|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||1.10|0.45|<0.0001
71694514|NCT01249417|142904059|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS means|5.32||||0.0006|TWO_SIDED|95.0|2.31|8.32|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||8.32|2.31|0.0006
71942547|NCT01993875|143406462|SUPERIORITY|||||||0.129||||||Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
71942548|NCT01993875|143406463|SUPERIORITY|||||||0.129||||||Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA|||||||0.1290
71942549|NCT01993875|143406464|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
71942550|NCT01993875|143406465|SUPERIORITY|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA|||||||0.2177
71942551|NCT01993875|143406466|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.|ANCOVA|||||||0.0664
71942552|NCT01993875|143406467|SUPERIORITY|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.|ANCOVA|||||||0.0664
71942553|NCT01312922|143406504|SUPERIORITY||Odds Ratio (OR)|0.987||||1|TWO_SIDED|95.0|0.456|2.14|||Fisher Exact|||||2.140|0.456|1.000
71942554|NCT01312922|143406504|SUPERIORITY||Odds Ratio (OR)|1.031||||1|TWO_SIDED|95.0|0.476|2.233|||Fisher Exact|||||2.233|0.476|1.000
71942555|NCT02227121|143406507|SUPERIORITY_OR_OTHER||Percentage|92.86|||||ONE_SIDED|95.0|70.3|||||||Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination \> 65%|||70.3|
71942556|NCT03929367|143406508|OTHER|Modeling of change of plasma oxytocin concentration over time using nonlinear canonical compartment model.|Bayesian information criterion|2.0|||||TWO_SIDED|||||||||||||
71694515|NCT01249417|142904059|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|4.65||||0.0031|TWO_SIDED|95.0|1.59|7.71|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.||7.71|1.59|0.0031
71694516|NCT01421498|142904089|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|0.24||||0.0007|TWO_SIDED|95.0|0.1|0.38|||t-test, 2 sided|||||0.38|0.10|0.0007
71694517|NCT01421498|142904090|SUPERIORITY_OR_OTHER_LEGACY||Treatment difference|-0.02||||0.786|TWO_SIDED|95.0|-0.15|0.11|||t-test, 2 sided|||||0.11|-0.15|0.7860
71694518|NCT00243919|142904095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.831||||0.481|TWO_SIDED|95.0|0.497|1.391||The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.|Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.||1.391|0.497|0.481
71694519|NCT00243919|142904095|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.192||||0.501|TWO_SIDED|95.0|0.715|1.985|||Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||1.985|0.715|0.501
71694520|NCT00243919|142904096|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.242||95.0||||We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.|Regression, Linear||Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.|The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.||||0.242
71694521|NCT00243919|142904097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.94||||0.01|TWO_SIDED|95.0|1.18|3.21|||Regression, Logistic|Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.21|1.18|0.010
71942557|NCT03929367|143406519|SUPERIORITY|Light touch detection frequency was compared over time in comparison to baseline using a one way analysis of variance for repeated measures. A power analysis was not performed for this secondary outcome measure.||||||0.89||||||No effect|ANOVA|||||||.89
71694522|NCT00243919|142904097|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.04||||0.007|TWO_SIDED|95.0|1.22|3.42|||Regression, Logistic|Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).||3.42|1.22|0.007
71694523|NCT00243919|142904098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|||<|0.0001|TWO_SIDED|95.0|0.08|0.16||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.||0.16|0.08|<0.0001
71694524|NCT00243919|142904098|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|||<|0.0001|TWO_SIDED|95.0|0.05|0.14||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p\<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.||0.14|0.05|<.0001
71694525|NCT00243919|142904099|SUPERIORITY_OR_OTHER|||||||0.45||95.0||||Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.|ANOVA|||Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.45
71942558|NCT03929367|143406526|SUPERIORITY|Sustained heat score at the end of each 5 minute session was compared to baseline across time using a one-way analysis of variance for repeated measures. Power analysis was not performed for this secondary outcome measure.||||||0.014|||||||ANOVA|||||||0.014
71942559|NCT00515203|143406545|SUPERIORITY_OR_OTHER|||||||0.0019|||||||Cochran-Mantel-Haenszel|||||||0.0019
71942560|NCT00515203|143406546|SUPERIORITY_OR_OTHER|||||||0.3651|||||||Cochran-Mantel-Haenszel|||||||0.3651
71942561|NCT00515203|143406547|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
71942562|NCT00515203|143406548|SUPERIORITY_OR_OTHER|||||||0.0008|||||||Fisher Exact|||||||0.0008
71942563|NCT00515203|143406549|SUPERIORITY_OR_OTHER|||||||0.2098|||||||Fisher Exact|||||||0.2098
71694526|NCT00243919|142904099|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
71694527|NCT00243919|142904100|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.||12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.10
71694528|NCT00243919|142904100|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.||6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.||||0.04
71694529|NCT00243919|142904101|SUPERIORITY_OR_OTHER|||||||0.48||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.48
71694530|NCT00243919|142904101|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
71694531|NCT00243919|142904102|SUPERIORITY_OR_OTHER|||||||0.07||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.07
71694532|NCT00243919|142904102|SUPERIORITY_OR_OTHER|||||||0.03||95.0|||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.03
71694533|NCT00243919|142904103|SUPERIORITY_OR_OTHER|||||||0.69||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.69
71694534|NCT00243919|142904103|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<.0001
71694535|NCT00243919|142904104|SUPERIORITY_OR_OTHER|||||||0.13||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.||12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.13
71694536|NCT00243919|142904104|SUPERIORITY_OR_OTHER|||||||0.04||95.0|||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.04
71694537|NCT00243919|142904105|SUPERIORITY_OR_OTHER|||||||0.06||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.06
71694538|NCT00243919|142904105|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.001
71942564|NCT01706536|143406556|SUPERIORITY||Least Squares Mean (SE)|0.1168|STANDARD_ERROR_OF_MEAN|0.04055||0.0043|TWO_SIDED|95.0|0.0369|0.1966|||Least squares mean (SE)|In order to control for Type I error rate, a gate keeping methodology was used.||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.1966|0.0369|0.0043
71694539|NCT00243919|142904106|SUPERIORITY_OR_OTHER|||||||0.62||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||0.62
71694540|NCT00243919|142904106|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.||||<0.001
71694541|NCT02059239|142904109|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|88.9|||||TWO_SIDED|95.0|65.3|98.6||||||||98.6|65.3|
71694542|NCT02059239|142904109|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|95.9||||||||95.9|54.4|
71694543|NCT02059239|142904110|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71694544|NCT02059239|142904110|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|75.3|100.0||||||||100.0|75.3|
71694545|NCT02059239|142904111|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71694546|NCT02059239|142904111|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|92.3|||||TWO_SIDED|95.0|64.0|99.8||||||||99.8|64.0|
71694547|NCT02059239|142904112|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71694548|NCT02059239|142904112|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|84.6|||||TWO_SIDED|95.0|54.6|98.1||||||||98.1|54.6|
71694549|NCT02059239|142904113|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|100.0|||||TWO_SIDED|95.0|79.4|100.0||||||||100.0|79.4|
71942565|NCT01706536|143406556|SUPERIORITY||Least Squares Mean (SE)|0.1284|STANDARD_ERROR_OF_MEAN|0.04089||0.0019|TWO_SIDED|95.0|0.0479|0.2089||In order to control for Type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2089|0.0479|0.0019
71694550|NCT02059239|142904113|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|46.2|||||TWO_SIDED|95.0|19.2|74.9||||||||74.9|19.2|
71694551|NCT02059239|142904114|OTHER|Simple proportion in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|0.0|||||TWO_SIDED|95.0|0.0|20.6||||||||20.6|0.0|
71942566|NCT01706536|143406556|SUPERIORITY||Least Squares Mean (SE)|0.1462|STANDARD_ERROR_OF_MEAN|0.04037||0.0004|TWO_SIDED|95.0|0.0667|0.2257||in order to control for Type 1 error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2257|0.0667|0.0004
71694552|NCT02059239|142904114|OTHER|Simple proportion in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|15.4|||||TWO_SIDED|95.0|1.9|45.4||||||||45.4|1.9|
71694553|NCT02059239|142904115|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|66.7|||||TWO_SIDED|95.0|41.0|86.7||||||||86.7|41.0|
71694554|NCT02059239|142904115|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|43.8|||||TWO_SIDED|95.0|19.8|70.1||||||||70.1|19.8|
71694555|NCT02059239|142904116|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|87.5|||||TWO_SIDED|95.0|61.7|98.4||||||||98.4|61.7|
71694556|NCT02059239|142904116|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|76.9|||||TWO_SIDED|95.0|46.2|95.0||||||||95.0|46.2|
71694557|NCT02059239|142904117|OTHER|Simple proportion (objective response: CR+PR) in autologous group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|81.3|||||TWO_SIDED|95.0|54.4|96.0||||||||96.0|54.4|
71694558|NCT02059239|142904117|OTHER|Simple proportion (objective response: CR+PR) in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Proportion (percent)|30.8|||||TWO_SIDED|95.0|9.1|61.4||||||||61.4|9.1|
71694559|NCT02059239|142904118|OTHER|Median PFS in allogeneic group with exact (Clopper-Pearson) 95% confidence interval.|Median (95% CI)|8.0|||||TWO_SIDED|95.0|5.0|25.0||||||||25|5|
71694560|NCT02318849|142904127|SUPERIORITY||Change in percentage|0.09||||0.009|TWO_SIDED||||||Mixed Models Analysis|The anaylsis was adjusted for student characteristics.||The null hypothesis was that the of number students who report being a donor (or talking to parents about organ donation) both before and after exposure to the intervention would be equivalent. A secondary null hypothesis would be that longer expsosures to the intervention over time would not increase the number who report becoming a donor at the final assessment.||||0.009
71694561|NCT02318849|142904128|SUPERIORITY||Change in percentage|0.0|||>|0.1|TWO_SIDED|||||Calculated|Mixed Models Analysis|||||||>0.10
71694562|NCT04585919|142904158|SUPERIORITY|||||||0.005|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.005
71694563|NCT04585919|142904159|SUPERIORITY|||||||0.19|||||||Mixed Models Analysis|Generalized linear mixed effect model controlling for secular trend, patient sociodemographic and health characteristics||||||0.19
71694564|NCT00731822|142904163|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.6|||||TWO_SIDED|95.0|-3.9|5.1||||||||5.1|-3.9|
71694565|NCT01435759|142904248|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.16|STANDARD_ERROR_OF_MEAN|1.01||0.004|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.|||||0.004
71694566|NCT01435759|142904248|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.5|STANDARD_ERROR_OF_MEAN|1.01||0.032|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.032
71942567|NCT01706536|143406556|SUPERIORITY||Least Squares Mean (SE)|0.177|STANDARD_ERROR_OF_MEAN|0.03953|<|0.0001|TWO_SIDED|95.0|0.0992|0.2548||in order to control for type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.||0.2548|0.0992|<0.0001
71942568|NCT00993187|143406577|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-0.8|||<|0.001|TWO_SIDED|95.0|-1.0|-0.6|||ANCOVA|||||-0.6|-1.0|<0.001
71942569|NCT00993187|143406580|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-23.5|||<|0.001|TWO_SIDED|95.0|-30.0|-16.9|||ANCOVA|||||-16.9|-30.0|<0.001
71942570|NCT00993187|143406581|SUPERIORITY_OR_OTHER||Difference in percent|-14.7|||<|0.001|TWO_SIDED|95.0|-23.0|-7.0|||ANCOVA|||||-7.0|-23.0|<0.001
71942571|NCT00993187|143406582|SUPERIORITY_OR_OTHER||Difference in Least Squares Mean|-1.72|||<|0.001|TWO_SIDED|95.0|-2.2|-1.25|||ANCOVA|||||-1.25|-2.20|<0.001
71942572|NCT00993187|143406583|SUPERIORITY_OR_OTHER||Difference in percent|41.01|||<|0.001|TWO_SIDED|95.0|30.0|51.0|||ANCOVA|||||51.0|30.0|<0.001
71942573|NCT04099888|143406589|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
71942574|NCT04099888|143406590|SUPERIORITY||||||||TWO_SIDED|95.0||||||||OS was analyzed using the modified intent-to-treat (mITT) analysis set, which included all randomized participants who received at least 1 dose of study treatment and had a RECIST assessment at baseline. Kaplan Meier Curve (KM) analysis of OS was completed for the mITT population, but the number of events was too small to draw any conclusions.|The HR was estimated using an unstratified cox-proportional hazards model using the Efron approach for handling ties (Efron 1977), together with the associated 95% confidence intervals (CI) for the HR based on the Wald method. The effect of treatment is summarized by the hazard ratio (HR) together with its corresponding 95% Wald CI for the mITT population. No p-value will be reported.|||
71942575|NCT04099888|143406591|SUPERIORITY|||||||||||||||||BOR is summarized by randomized treatment group using the mITT analysis set.|The BOR is the best response recorded from the start of the treatment until disease progression or until the last evaluable assessment in the absence of progression. If a patient received subsequent anti-cancer therapy prior to progression, then BOR was calculated up to the point of starting the anti-cancer therapy.|||
71942576|NCT04099888|143406592|SUPERIORITY||||||||TWO_SIDED|95.0|||||||||The ORR is calculated as the proportion of patients who have at least one visit response with a complete response (CR) or partial response (PR). Objective responses do not require confirmation in a randomized study. Data obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the analysis of ORR. Data obtained up until progression or subsequent therapy, or last evaluable assessment in the absence of progression or subsequent therapy, will be included in the analysis of ORR.|||
71694567|NCT01435759|142904248|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean|3.28|STANDARD_ERROR_OF_MEAN|1.01||0.003|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
71694568|NCT01435759|142904248|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.91|STANDARD_ERROR_OF_MEAN|1.01||0.01|TWO_SIDED||||||MCP-Mod Analysis Method|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.010
71694569|NCT01435759|142904248|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.15|STANDARD_ERROR_OF_MEAN|1.01||0.005|TWO_SIDED||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
71694570|NCT01435759|142904249|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.16|STANDARD_ERROR_OF_MEAN|0.75||0.011|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.|||||0.011
71694571|NCT01435759|142904249|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|1.95|STANDARD_ERROR_OF_MEAN|0.75||0.023|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.|||||0.023
71694572|NCT01435759|142904249|SUPERIORITY_OR_OTHER_LEGACY||MCP-Mod Analysis|2.47|STANDARD_ERROR_OF_MEAN|0.75||0.003|TWO_SIDED||||||Least Squares Means|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.|||||0.003
71694573|NCT01435759|142904249|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.22|STANDARD_ERROR_OF_MEAN|0.76||0.009|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||0.009
71694574|NCT01435759|142904249|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|2.37|STANDARD_ERROR_OF_MEAN|0.76||0.005|TWO_SIDED||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.|||||0.005
71694575|NCT01435759|142904250|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.45|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax|||||<0.001
71694576|NCT01435759|142904250|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|3.52|STANDARD_ERROR_OF_MEAN|1.05||0.002|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.|||||0.002
71694577|NCT01435759|142904250|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.3|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.|||||<0.001
71694578|NCT01435759|142904250|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.|||||<0.001
71694579|NCT01435759|142904250|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|4.63|STANDARD_ERROR_OF_MEAN|1.05|<|0.001|TWO_SIDED||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.|||||<0.001
71694580|NCT01435759|142904251|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.11|STANDARD_ERROR_OF_MEAN|1.07||1|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis Method|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||1.000
71694581|NCT01435759|142904251|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.43|STANDARD_ERROR_OF_MEAN|1.06||0.942|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.942
71694582|NCT01435759|142904251|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|0.21|STANDARD_ERROR_OF_MEAN|1.06||0.995|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.||||0.995
71694583|NCT01435759|142904251|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Means|-0.32|STANDARD_ERROR_OF_MEAN|1.07||0.978|ONE_SIDED|||||Any p-value \<=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.|Analysis of Dose-Response Using the MCP-Mod Analysis Method||||0.978
71694584|NCT02849587|142904257|SUPERIORITY||||||<|0.001|||||||Generalized least squares model|||||||<0.001
71694585|NCT02849587|142904258|SUPERIORITY|||||||0.022|||||||Generalized least squares model|Raw data converted to z-score based on pre-smoking performance of entire sample.||||||0.022
71694586|NCT02849587|142904259|SUPERIORITY|||||||0.283|||||||Generalized least squares model|||||||0.283
71694587|NCT02849587|142904260|SUPERIORITY|||||||0.0503|||||||Generalized estimating equations model|||||||0.0503
71694588|NCT02849587|142904261|SUPERIORITY|||||||0.024|||||||Generalized least squares model|||||||0.024
71694589|NCT02849587|142904262|SUPERIORITY|||||||0.716|||||||Generalized least squares model|The outcome was standardized prior to analyses.||||||0.716
71694590|NCT02849587|142904263|SUPERIORITY|||||||0.005|||||||Generalized least squares model|The outcome was standardized prior to analysis.||||||0.005
71694591|NCT02849587|142904264|SUPERIORITY|||||||0.366|||||||Generalized Estimating Equations model|||||||.366
71694592|NCT02849587|142904265|SUPERIORITY|||||||0.225|||||||Generalized least squares model|Outcome was log10 transformed prior to analyses.||||||.225
71942577|NCT04099888|143406593|SUPERIORITY|||||||||||||||||The DoR was calculated only for those with a documented response of CR or PR and is defined as the time from the date of first documented tumor response until the first date of documented disease progression or death, whichever is earlier.|DoR is listed only. In Arm A, the duration of response was 169 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm A, the events were censored at 260 and 264 days, respectively. In Arm B, the duration of response was 85 days in 1 participant before radiological progression was seen. In the other 2 participants in Arm B, the events were censored at 1 day due to the early termination of the study.|||
71694593|NCT02849587|142904266|SUPERIORITY|||||||0.592|||||||Generalized least squares model|The outcome was transformed using logit function prior to analyses. Model included treatment (3 groups), time (5 times), and their interaction.||||||.592
71694594|NCT02849587|142904267|SUPERIORITY|||||||0.294|||||||Generalized least squares model|||||||.294
71694595|NCT02849587|142904268|SUPERIORITY|||||||0.144|||||||Generalized least squares model|||||||.144
71694596|NCT02849587|142904269|OTHER|Spearman's correlation||||||0.09|||||||Spearman's correlation|||||||0.090
71694597|NCT02849587|142904269|OTHER|Spearman's correlation||||||0.0006|||||||Spearman's correlation|||||||.0006
71694598|NCT02849587|142904269|OTHER|Spearman's correlation||||||0.053|||||||Spearman's correlation|||||||0.053
71694599|NCT02849587|142904270|OTHER|Spearman's correlation||||||0.3|||||||Spearman's correlation|||||||0.300
71694600|NCT02849587|142904270|OTHER|Spearman's correlation||||||0.038|||||||Spearman's correlation|||||||0.038
71694601|NCT02849587|142904270|OTHER|Spearman's correlation||||||0.175|||||||Spearman's correlation|||||||0.175
71694602|NCT04536701|142904292|SUPERIORITY|||||||0.444|||||||t-test, 2 sided|||Total DASS score reported.||||0.444
71694603|NCT04536701|142904292|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||Depressive Mood DASS score reported||||0.8378
71694604|NCT04536701|142904292|SUPERIORITY|||||||0.4087|||||||t-test, 2 sided|||Anxiety DASS score reported||||0.4087
71694605|NCT04536701|142904292|SUPERIORITY|||||||0.4124|||||||t-test, 2 sided|||Stress DASS score reported||||0.4124
71694606|NCT04536701|142904293|SUPERIORITY|||||||0.0508|||||||t-test, 2 sided|||Total RMBPC frequency reported||||0.0508
71694607|NCT04536701|142904293|SUPERIORITY|||||||0.026|||||||t-test, 2 sided|||Frequency of disruptive symptoms on RMBP reported||||0.026
71694608|NCT04536701|142904293|SUPERIORITY|||||||0.1861|||||||t-test, 2 sided|||Frequency of depressive symptoms on RMBPC reported||||0.1861
71694609|NCT04536701|142904293|SUPERIORITY|||||||0.9535|||||||t-test, 2 sided|||Frequency of memory symptoms on RMBPC reported||||0.9535
71694610|NCT04536701|142904293|SUPERIORITY|||||||0.0411|||||||t-test, 2 sided|||RMBPC reaction total is reported||||0.0411
71694611|NCT04536701|142904293|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||RMBPC reaction disruptive symptoms is reported||||0.0058
71694612|NCT04536701|142904293|SUPERIORITY|||||||0.2527|||||||t-test, 2 sided|||RMBPC reaction depressive symptoms is reported||||0.2527
71694613|NCT04536701|142904293|SUPERIORITY|||||||0.3542|||||||t-test, 2 sided|||RMBPC reaction memory symptoms||||0.3542
71694614|NCT04536701|142904294|SUPERIORITY|||||||0.3857|||||||t-test, 2 sided|||||||0.3857
71694615|NCT04536701|142904295|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||Five Facet Mindfulness Questionnaire (FFMQ) total reported||||0.7213
71694616|NCT04536701|142904295|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FFMQ Observing reported||||0.6075
71694617|NCT04536701|142904295|SUPERIORITY|||||||0.4136|||||||t-test, 2 sided|||FFMQ Describing reported||||0.4136
71694618|NCT04536701|142904295|SUPERIORITY|||||||0.8378|||||||t-test, 2 sided|||FFMQ Acting with Awareness reported||||0.8378
71694619|NCT04536701|142904295|SUPERIORITY|||||||0.7193|||||||t-test, 2 sided|||FFMQ Nonjudging reported||||0.7193
71694620|NCT04536701|142904295|SUPERIORITY|||||||0.4145|||||||t-test, 2 sided|||FFMQ Nonreactivity reported||||0.4145
71694621|NCT04536701|142904296|SUPERIORITY|||||||0.5368|||||||t-test, 2 sided|||||||0.5368
71694622|NCT04536701|142904297|SUPERIORITY|||||||0.2845|||||||t-test, 2 sided|||FAD Total reported||||0.2845
71694623|NCT04536701|142904297|SUPERIORITY|||||||0.1386|||||||t-test, 2 sided|||FAD Problem Solving is reported||||0.1386
71694624|NCT04536701|142904297|SUPERIORITY|||||||0.7551|||||||t-test, 2 sided|||FAD Communication is reported||||0.7551
71694625|NCT04536701|142904297|SUPERIORITY|||||||0.7213|||||||t-test, 2 sided|||FAD Roles is reported||||0.7213
71694626|NCT04536701|142904297|SUPERIORITY|||||||0.3233|||||||t-test, 2 sided|||FAD Affective Responsiveness is reported||||0.3233
71694627|NCT04536701|142904297|SUPERIORITY|||||||0.2832|||||||t-test, 2 sided|||FAD Affective Involvement is reported||||0.2832
71694628|NCT04536701|142904297|SUPERIORITY|||||||0.6831|||||||t-test, 2 sided|||FAD Behavior Control is reported||||0.6831
71694629|NCT04536701|142904297|SUPERIORITY|||||||0.6075|||||||t-test, 2 sided|||FAD General Functioning is reported||||0.6075
71694630|NCT00549549|142904311|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||-0.18|-0.74|
71694631|NCT00549549|142904311|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||||0.04|-0.52|
71694632|NCT00549549|142904311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||||0.84|0.29|
71694633|NCT00549549|142904311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||||0.60|0.05|
71694634|NCT00549549|142904311|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||||0.39|-0.17|
71694635|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.29|0.14|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.14|-0.29|
71694636|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.42|0.02|||ANCOVA|||Day 5 analysis||0.02|-0.42|
71694637|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.04|0.47|||ANCOVA|||Day 5 analysis||0.47|0.04|
71694638|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.04|0.39|||ANCOVA|||Day 5 analysis||0.39|-0.04|
71694639|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 5 analysis||0.27|-0.16|
71694640|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.26|0.16|||ANCOVA|||Day 9 analysis||0.16|-0.26|
71694641|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.4|0.03|||ANCOVA|||Day 9 analysis||0.03|-0.40|
71694642|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.32|||ANCOVA|||Day 9 analysis||0.32|-0.11|
71694643|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.16|0.27|||ANCOVA|||Day 9 analysis||0.27|-0.16|
71694644|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.3|0.13|||ANCOVA|||Day 9 analysis||0.13|-0.30|
71694645|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.33|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.33|
71694646|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.11|||ANCOVA|||Day 14/early termination analysis||-0.11|-0.53|
71694647|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.05|0.37|||ANCOVA|||Day /early termination analysis||0.37|-0.05|
71694648|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.17|0.25|||ANCOVA|||Day 14/early termination analysis||0.25|-0.17|
71694649|NCT00549549|142904312|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.38|0.05|||ANCOVA|||Day 14/early termination analysis||0.05|-0.38|
71694650|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.29|0.22|||ANCOVA|||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.||0.22|-0.29|
71694651|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.35|0.16|||ANCOVA|||Day 5 analysis.||0.16|-0.35|
71694652|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.17|0.34|||ANCOVA|||Day 5 analysis.||0.34|-0.17|
71694653|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.2|0.3|||ANCOVA|||Day 5 analysis.||0.30|-0.20|
71694654|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.26|0.25|||ANCOVA|||Day 5 analysis.||0.25|-0.26|
71694655|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.11|||ANCOVA|||Day 9 analysis.||0.11|-0.36|
71694656|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.44|0.04|||ANCOVA|||Day 9 analysis.||0.04|-0.44|
71694657|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.01|0.46|||ANCOVA|||Day 9 analysis.||0.46|-0.01|
71694658|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.14|0.33|||ANCOVA|||Day 9 analysis.||0.33|-0.14|
71694659|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 9 analysis.||0.26|-0.22|
71694660|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.38|0.1|||ANCOVA|||Day 14/early termination analysis||0.10|-0.38|
71694661|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.52|-0.04|||ANCOVA|||Day 14/early termination analysis||-0.04|-0.52|
71694662|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.08|0.39|||ANCOVA|||Day 14/early termination analysis||0.39|-0.08|
71694663|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.22|0.26|||ANCOVA|||Day 14/early termination analysis||0.26|-0.22|
71694664|NCT00549549|142904313|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.36|0.12|||ANCOVA|||Day 14/early termination analysis||0.12|-0.36|
71942578|NCT04099888|143406594|SUPERIORITY||||||||TWO_SIDED|95.0||||||||DCR is reported and includes any patient with a best response of stable disease, PR or CR.|The DCR and associated exact 95% CI is summarized for the mITT population. This was repeated for DCR-6, defined as the proportion of patients with CR, PR or SD at 6 months (recorded at least 24 weeks (+/-1 week) after randomization of study treatment and prior to any PD event).|||
71942579|NCT04099888|143406595|SUPERIORITY|||||||||||||||||Change in tumor size in percentage was summarized for the subset of patients in the mITT analysis set who had measurable disease at baseline.|Tumor size is defined as the sum of the longest diameters (SoDs) of the RECIST 1.1 target lesions. Change in tumor size is defined as the best overall percentage change in tumor size from baseline. Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the SoDs of target lesions compared to baseline.|||
71942580|NCT04099888|143406596|SUPERIORITY||||||||||||||||||Safety, including the incidence and characteristics of biliary/loco-regional tumour-related events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
71942581|NCT04099888|143406597|SUPERIORITY||||||||||||||||||Safety events leading to hospitalisation and/or interventions, will be summarised descriptively.|||
71942582|NCT04099888|143406601|SUPERIORITY||||||||||||||||||As this study was terminated early, a reduced statistical analysis was conducted, and the HRQoL analyses were not conducted.|||
71942583|NCT04538170|143406602|SUPERIORITY|||||||0.013||||||threshold for statistical significance|Fisher Exact|||Preliminary work showed that approximately 25% of patients report phantom pain after orchidectomy. A difference of 20% between the GAC and ORC groups was considered relevant. Power was set to 80% and the significance level to 5%, resulting in a minimum of 40 women to be recruited, which was fulfilled.||||0.013
71942584|NCT00445003|143406605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.6|||<|0.001|TWO_SIDED|95.0|2.2|9.0||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparison|||9.0|2.2|<.001
71942585|NCT00445003|143406605|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.7|||<|0.001|TWO_SIDED|95.0|3.2|10.1||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparisons|||10.1|3.2|<.001
71942586|NCT00445003|143406607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-35.0|||<|0.01|TWO_SIDED|95.0|-64.0|-6.0||Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-6|-64|<.01
71942587|NCT00445003|143406607|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-100.0|||<|0.001|TWO_SIDED|95.0|-128.0|-71.0||adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-71|-128|<.001
71942588|NCT00445003|143406609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.9||||0.44|TWO_SIDED|95.0|-3.7|7.5||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||7.5|-3.7|0.44
71942589|NCT00445003|143406609|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.2||||0.63|TWO_SIDED|95.0|-4.4|6.8||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||6.8|-4.4|0.63
71942590|NCT00445003|143406612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.001|TWO_SIDED|95.0|-1.0|-0.2||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-0.2|-1.0|0.001
71942591|NCT00445003|143406612|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.7|||<|0.001|TWO_SIDED|95.0|-2.1|-1.3||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons|||-1.3|-2.1|<.001
71942592|NCT02334722|143406613|SUPERIORITY||Median Difference (Final Values)|-2.5||||0.7824|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.7824
71942593|NCT03661528|143406622|OTHER||Percentage proportion difference|13.4||||0.0032|TWO_SIDED|95.0|4.6|22.2|||Cochran-Mantel-Haenszel|||||22.2|4.6|0.0032
71942594|NCT03661528|143406623|OTHER||Difference in least squares mean|-185.99|||<|0.0001|TWO_SIDED|95.0|-199.93|-172.05|||ANCOVA|Analysis presented for ANCOVA based on ranks.||||-172.05|-199.93|<0.0001
71942595|NCT00686959|143406666|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98||||0.831|TWO_SIDED|95.0|0.79|1.2|||Log Rank|||||1.20|0.79|0.831
71942596|NCT00686959|143406667|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.86||||0.13|TWO_SIDED|95.0|0.71|1.04|||Log Rank|||||1.04|0.71|0.130
71942597|NCT00686959|143406668|SUPERIORITY_OR_OTHER|||||||0.458|TWO_SIDED||||||Log Rank|||||||0.458
71942598|NCT00686959|143406671|SUPERIORITY_OR_OTHER|||||||0.132|TWO_SIDED||||||Fisher Exact|||Relapsed within the radiation treatment field||||0.132
71942599|NCT00686959|143406671|SUPERIORITY_OR_OTHER|||||||0.337|TWO_SIDED||||||Fisher Exact|||Relapsed inside thorax, outside of radiation field||||0.337
71942600|NCT00686959|143406671|SUPERIORITY_OR_OTHER|||||||0.457|TWO_SIDED||||||Fisher Exact|||Relapsed distant disease||||0.457
71694665|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6402|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6402
71694666|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9739|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.9739
71694667|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4581|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4581
71694668|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2962|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.2962
71694669|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4951|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4951
71942601|NCT00686959|143406672|SUPERIORITY_OR_OTHER|||||||0.15|TWO_SIDED||||||Fisher Exact|||||||0.150
71942602|NCT01212874|143406682|SUPERIORITY_OR_OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.21
71694670|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4957|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4957
71694671|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.8364|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.8364
71694672|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6892|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.6892
71694673|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.411|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4110
71694674|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5981|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5981
71694675|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.9317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.9317
71694676|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0831|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0831
71694677|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5747|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5747
71694678|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6204|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.6204
71694679|NCT00549549|142904314|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2556|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analysis||||0.2556
71694680|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1444|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1444
71694681|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7532|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.7532
71694682|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4722|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.4722
71942603|NCT01212874|143406683|SUPERIORITY_OR_OTHER|||||||0.04|||||||t-test, 2 sided|||||||0.04
71942604|NCT03553823|143406700|SUPERIORITY||Difference secukinumab vs guselkumab|20.0||||0.1715|TWO_SIDED|95.0|-13.3|50.3|||Fisher Exact|The statistical model was the Fisher's exact test for the difference in proportions.||"Proportion of subjects whose plaque achieves clear or almost clear status (TCS = 0-2)"||50.3|-13.3|0.1715
71942605|NCT00615069|143406749|SUPERIORITY_OR_OTHER|||||||0.003|TWO_SIDED|95.0|||||Log Rank|||Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.||||0.003
71694683|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3878|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.3878
71694684|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6717|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 5 analyses||||0.6717
71694685|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3098|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.3098
71694686|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4356|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4356
71694687|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5703|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.5703
71694688|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4986|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.4986
71694689|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7855|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 9 analyses||||0.7855
71694690|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0169|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0169
71694691|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1353|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.1353
71694692|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.369|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.3690
71694693|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0787|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.0787
71694694|NCT00549549|142904315|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5687|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses||||0.5687
71694695|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||-0.10|-0.60|
71694696|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.75|-0.25|||ANCOVA|||Day 1 analyses||-0.25|-0.75|
71694697|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.54|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.29|0.78|||ANCOVA|||Day 1 analyses||0.78|0.29|
71694698|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.06|0.44|||ANCOVA|||Day 1 analyses||0.44|-0.06|
71694699|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.21|0.28|||ANCOVA|||Day 1 analyses||0.28|-0.21|
71694700|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.52|0.04|||ANCOVA|||Day 2 analyses||0.04|-0.52|
71694701|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.74|-0.18|||ANCOVA|||Day 2 analyses||-0.18|-0.74|
71694702|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.84|||ANCOVA|||Day 2 analyses||0.84|0.29|
71694703|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.33|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.05|0.6|||ANCOVA|||Day 2 analyses||0.60|0.05|
71694704|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.17|0.39|||ANCOVA|||Day 2 analyses||0.39|-0.17|
71694705|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.53|0.03|||ANCOVA|||Day 3 analyses||0.03|-0.53|
71694706|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.83|-0.26|||ANCOVA|||Day 3 analyses||-0.26|-0.83|
71942606|NCT00615069|143406750|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.241|||||TWO_SIDED|95.0|0.428|3.603||||||Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.||3.603|0.428|
71942607|NCT00259012|143406781|SUPERIORITY_OR_OTHER|||||||0.087|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.087
71942608|NCT00259012|143406781|SUPERIORITY_OR_OTHER|||||||0.019|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.019
71942609|NCT00259012|143406782|SUPERIORITY_OR_OTHER|||||||0.255|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline||||0.255
71942610|NCT00259012|143406782|SUPERIORITY_OR_OTHER|||||||0.031|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline.||||0.031
71942611|NCT00259012|143406783|SUPERIORITY_OR_OTHER|||||||0.099|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.099
71942612|NCT00259012|143406783|SUPERIORITY_OR_OTHER|||||||0.016|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.016
71942613|NCT00259012|143406784|SUPERIORITY_OR_OTHER|||||||0.347|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.347
71942614|NCT00259012|143406784|SUPERIORITY_OR_OTHER|||||||0.012|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.012
71942615|NCT00259012|143406785|SUPERIORITY_OR_OTHER|||||||0.339|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.339
71942616|NCT00259012|143406785|SUPERIORITY_OR_OTHER|||||||0.003|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.003
71942617|NCT00259012|143406786|SUPERIORITY_OR_OTHER|||||||0.982|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.982
71942618|NCT00259012|143406786|SUPERIORITY_OR_OTHER|||||||0.534|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.534
71694707|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.32|0.88|||ANCOVA|||Day 3 analyses||0.88|0.32|
71942619|NCT00259012|143406787|SUPERIORITY_OR_OTHER|||||||0.166|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.166
71942620|NCT00259012|143406787|SUPERIORITY_OR_OTHER|||||||0.119|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.119
71942621|NCT00259012|143406788|SUPERIORITY_OR_OTHER|||||||0.387|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.387
71942622|NCT00259012|143406788|SUPERIORITY_OR_OTHER|||||||0.021|||||||t-test, 2 sided|||Within group comparison between steady state and baseline||||0.021
71942623|NCT04625114|143406847|SUPERIORITY||Mean Difference (Final Values)|1.183||||0.511|TWO_SIDED||||||Mixed Models Analysis|||||||0.511
71942624|NCT04625114|143406848|SUPERIORITY||Cox Proportional Hazard|0.965||||0.921|TWO_SIDED|95.0|0.48|1.942|||Regression, Cox|||||1.942|0.480|0.921
71942625|NCT03221374|143406867|OTHER|Linear mixed effect model to test the overall BCI learning between MBSR and control groups||||||0.003||||||The threshold for statistical analysis was p = 0.05.|Mixed Models Analysis|||||||0.003
71694708|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.08|0.64|||ANCOVA|||Day 3 analyses||0.64|0.08|
71694709|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.22|0.34|||ANCOVA|||Day 3 analyses||0.34|-0.22|
71942626|NCT03221374|143406867|EQUIVALENCE|This independent t-test will test if the two groups (MBSR, control) exhibit a statistically significant difference in terms of BCI performance from baseline.|Mean Difference (Net)|8.98||||0.024|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|t-test, 2 sided||The difference between BCI performance improvement in MBSR cohort and control cohort.|||||0.024
71942627|NCT03221374|143406868|EQUIVALENCE|This WRS test will determine if the MBSR group breath counting accuracy was significantly greater than the postintervention levels of controls.|Mean Difference (Net)|15.4|||<|0.001|TWO_SIDED|||||The threshold for statistical analysis was p = 0.05|Wilcoxon (Mann-Whitney)|||||||<0.001
71942628|NCT03221374|143406869|EQUIVALENCE|The null hypothesis is that the FMI scores of the two groups have equal medians.|Mean Difference (Final Values)|7.9|||<|0.01|TWO_SIDED|||||significant if p\<0.05|Wilcoxon (Mann-Whitney)|||||||<0.01
71942629|NCT03221374|143406869|EQUIVALENCE|The null hypothesis is that the MAAS scores of the two groups have equal medians.|Mean Difference (Final Values)|0.69|||<|0.05|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||<0.05
71942630|NCT03221374|143406869|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the FMI score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.42|||<|0.05|TWO_SIDED|||||significant if p\<0.05|Regression, Linear|||||||<0.05
71942631|NCT03221374|143406869|OTHER|This statistical test is about the correlation between baseline up-down BCI performance and the MAAS score. A linear regression model is used to test if the slope is non-zero.|correlation coefficient|0.41|||<|0.05|TWO_SIDED||||||Regression, Linear|||||||<0.05
71942632|NCT04448678|143406873|OTHER|||||||0.0401|||||||t-test, 2 sided|||||||0.0401
71942633|NCT04448678|143406874|OTHER|||||||0.0049|||||||t-test, 2 sided|||||||0.0049
71942634|NCT04448678|143406875|OTHER|||||||0.297|||||||t-test, 2 sided|||||||0.297
71942635|NCT02567968|143406876|SUPERIORITY|||||||0.002|||||||paired t-test|||||||0.002
71942636|NCT02016170|143406885|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined). Under the assumption of 0 difference in mean PRU between ticagrelor 90 mg bid MD and prasugrel 10 mg qd MD and a common standard deviation of 60 PRU, a sample size of 24 patients per group allowed for the 95% CI to stay within ± 45 PRU with a 90% power and alpha=0.05.|Mean Difference (Final Values)|-18.0|||||TWO_SIDED|95.0|-41.0|5.0||||||||5|-41|
71942637|NCT02016170|143406886|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined).|Mean Difference (Final Values)|-11.0|||||TWO_SIDED|95.0|-18.0|-4.0||||||||-4|-18|
71942638|NCT00336479|143406887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.985||||0.0014|TWO_SIDED|95.0|1.525|5.842|||Regression, Logistic|Treatment, weight, race and baseline HCV RNA as factors||||5.842|1.525|0.0014
71942639|NCT00336479|143406887|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.17||||0.0204|TWO_SIDED|95.0|1.127|4.178|||Regression, Logistic|||||4.178|1.127|0.0204
71694710|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.28|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.56|0.0|||ANCOVA|||Day 4 analyses||-0.00|-0.56|
71942640|NCT00336479|143406888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.586||||0.0051|TWO_SIDED|95.0|1.331|5.025|||Regression, Logistic|||||5.025|1.331|0.0051
71942641|NCT00336479|143406888|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.976||||0.0418|TWO_SIDED|95.0|1.026|3.807|||Regression, Logistic|||||3.807|1.026|0.0418
71942642|NCT01395030|143406902|OTHER||||||||||||||||||"Analysis was performed using Gene Set Enrichment Analysis (GSEA version 19.0.24, Broad Institute, Cambridge, MA) implemented in GenePattern (Broad Institute, Cambridge, MA) by uploading expression array data to this cloud-computing genomics platform. The specific details of this statistical approach can be found in the following publicly available references:~Reich M, Liefeld T, Gould J, Lerner J, Tamayo P, Mesirov JP. GenePattern 2.0 Nature Genetics 38 no. 5 (2006): pp500-501~Subramanian A, Tamayo P, Mootha VK, Mukherjee S, Ebert BL, Gillette MA, Paulovich A, Pomeroy SL, Golub TR, Lander ES, Mesirov JP. Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles. PNAS. 2005;102(43);15545-15550."|||
71942643|NCT02079766|143406905|OTHER|||||||0.2959||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|Fisher Exact|||Evaluated the association between the overall brain uptake and the study group||||0.2959
71942644|NCT02079766|143406906|OTHER|||||||0.5163||||||No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.|ANOVA|MMSE score as the response variable and flortaucipir uptake score (4 levels) as the fixed effect||Measured differences in clinical presentation using MMSE between subjects with no visual flortaucipir uptake, and those with mild uptake.||||0.5163
71942645|NCT04166032|143406933|OTHER|||||||0.21|||||||t-test, 2 sided|||||||0.210
71942646|NCT03117569|143406965|NON_INFERIORITY|A total of 375 participants (2:1 randomisation) were planned for enrolment and evaluation as ITT population. Under the assumption that SVR12 rate would be 96% in both arms, the study had 80% power to show non-inferiority of the simplified monitoring strategy with a lower confidence bound for SVR12 in the simplified monitoring arm greater than 90% or with a lower confidence bound for the difference (simplified arm minus standard arm) in SVR12 greater than -6%.|Difference in Percentage of Participants|-3.2|||<|0.05|TWO_SIDED|95.0|-8.2|1.8|||t-test, 2 sided|||||1.8|-8.2|<0.05
71942647|NCT01569152|143406977|SUPERIORITY_OR_OTHER||Difference of percentages|43.9|||<|0.001|TWO_SIDED|95.0|24.52|63.28|||Cochran-Mantel-Haenszel|||||63.28|24.52|<0.001
71942648|NCT01569152|143406978|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.98|||<|0.001|TWO_SIDED|95.0|-1.53|-0.43|||Constrained Longitudinal Data Analysis|||||-0.43|-1.53|<0.001
71942649|NCT01569152|143406979|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.11|||<|0.001|TWO_SIDED|95.0|-1.62|-0.6|||Constrained Longitudinal Data Analysis|||||-0.60|-1.62|<0.001
71942650|NCT01569152|143406980|SUPERIORITY_OR_OTHER||Difference in percentages|14.63||||0.044|TWO_SIDED|95.0|0.83|28.44|||Cochran-Mantel-Haenszel|||||28.44|0.83|0.044
71942651|NCT01569152|143406983|SUPERIORITY_OR_OTHER||Difference in percentages|31.71||||0.004|TWO_SIDED|95.0|11.29|52.13|||Cochran-Mantel-Haenszel|||||52.13|11.29|0.004
71942652|NCT01569152|143406984|SUPERIORITY_OR_OTHER||Difference in percentages|29.27||||0.007|TWO_SIDED|95.0|8.9|49.63|||Cochran-Mantel-Haenszel|||||49.63|8.90|0.007
71942653|NCT01569152|143406985|SUPERIORITY_OR_OTHER||Difference in percentages|9.76||||0.039|TWO_SIDED|95.0|0.67|18.84|||Cochran-Mantel-Haenszel|||||18.84|0.67|0.039
71942654|NCT01569152|143406986|SUPERIORITY_OR_OTHER||Difference in percentages|12.2||||0.018|TWO_SIDED|95.0|2.18|22.21|||Cochran-Mantel-Haenszel|||||22.21|2.18|0.018
71942655|NCT01569152|143406989|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.75||||0.028|TWO_SIDED|95.0|-8.99|-0.52|||Constrained Longitudinal Data Analysis|||||-0.52|-8.99|0.028
71942656|NCT01569152|143406990|SUPERIORITY_OR_OTHER||Difference in least squares means|-2.65||||0.11|TWO_SIDED|95.0|-5.91|0.62|||Constrained Longitudinal Data Analysis|||||0.62|-5.91|0.110
71942657|NCT01569152|143406991|SUPERIORITY_OR_OTHER||Difference in least squares means|-10.56||||0.002|TWO_SIDED|95.0|-16.97|-4.15|||Constrained Longitudinal Data Analysis|||||-4.15|-16.97|0.002
71942658|NCT01569152|143406994|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.84|||<|0.001|TWO_SIDED|95.0|-29.98|-11.71|||Constrained Longitudinal Data Analysis|||||-11.71|-29.98|<0.001
71942659|NCT01569152|143406995|SUPERIORITY_OR_OTHER||Difference in least squares means|-19.48|||<|0.001|TWO_SIDED|95.0|-29.69|-9.28|||Constrained Longitudinal Data Analysis|||||-9.28|-29.69|<0.001
71942660|NCT01569152|143406996|SUPERIORITY_OR_OTHER||Difference in least squares means|-20.69|||<|0.001|TWO_SIDED|95.0|-31.29|-10.09|||Constrained Longitudinal Data Analysis|||||-10.09|-31.29|<0.001
71942661|NCT01569152|143406997|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.62|||<|0.001|TWO_SIDED|95.0|-0.84|-0.4|||Constrained Longitudinal Data Analysis|||||-0.40|-0.84|< 0.001
71942662|NCT01569152|143406998|SUPERIORITY_OR_OTHER||Difference in least squares means|-1.59||||0.007|TWO_SIDED|95.0|-2.73|-0.45|||Constrained Longitudinal Data Analysis|||||-0.45|-2.73|0.007
71942663|NCT01569152|143406999|SUPERIORITY_OR_OTHER||Difference in least squares means|-4.9||||0.315|TWO_SIDED|95.0|-14.54|4.74|||Constrained Longitudinal Data Analysis|||||4.74|-14.54|0.315
71942664|NCT01569152|143407001|SUPERIORITY_OR_OTHER||Difference in percentages|31.71|||<|0.001|TWO_SIDED|95.0|15.56|47.86|||Cochran-Mantel-Haenszel|||||47.86|15.56|<0.001
71942665|NCT00154102|143407026|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.853||||0.0479|TWO_SIDED|95.0|0.728|1.0|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\<80 vs. ≥80)||1.000|0.728|0.0479
71694711|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.28|||ANCOVA|||Day 4 analyses||-0.28|-0.84|
71694712|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.62|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.35|0.9|||ANCOVA|||Day 4 analyses||0.90|0.35|
71694713|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.07|0.62|||ANCOVA|||Day 4 analyses||0.62|0.07|
71942666|NCT00154102|143407027|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.696||||0.0012|TWO_SIDED|95.0|0.558|0.867|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.867|0.558|0.0012
71942667|NCT00154102|143407028|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.171||||0.2648|TWO_SIDED|95.0|0.887|1.544|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.544|0.887|0.2648
71694714|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.21|0.34|||ANCOVA|||Day 4 analyses||0.34|-0.21|
71694715|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.64|-0.07|||ANCOVA|||Day 5 analyses||-0.07|-0.64|
71694716|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.66|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.94|-0.38|||ANCOVA|||Day 5 analyses||-0.38|-0.94|
71694717|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.65|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.37|0.93|||ANCOVA|||Day 5 analyses||0.93|0.37|
71694718|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.02|0.57|||ANCOVA|||Day 5 analyses||0.57|0.02|
71694719|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.29|0.27|||ANCOVA|||Day 5 analyses||0.27|-0.29|
71694720|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.65|-0.1|||ANCOVA|||Day 6 analyses||-0.10|-0.65|
71694721|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.57|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.29|||ANCOVA|||Day 6 analyses||-0.29|-0.84|
71694722|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.29|0.83|||ANCOVA|||Day 6 analyses||0.83|0.29|
71694723|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.08|0.46|||ANCOVA|||Day 6 analyses||0.46|-0.08|
71942668|NCT00154102|143407029|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878||||0.0419|TWO_SIDED|95.0|0.774|0.995|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.995|0.774|0.0419
71694724|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.28|0.26|||ANCOVA|||Day 6 analyses||0.26|-0.28|
71694725|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.04|||ANCOVA|||Day 7 analyses||-0.04|-0.61|
71694726|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.92|-0.34|||ANCOVA|||Day 7 analyses||-0.34|-0.92|
71694727|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.49|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.21|0.78|||ANCOVA|||Day 7 analyses||0.78|0.21|
71694728|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.45|||ANCOVA|||Day 7 analyses||0.45|-0.11|
71694729|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.15|||ANCOVA|||Day 7 analyses||0.15|-0.42|
71694730|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|0.0|||ANCOVA|||Day 8 analyses||-0.00|-0.57|
71694731|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.84|-0.27|||ANCOVA|||Day 8 analyses||-0.27|-0.84|
71694732|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.14|0.7|||ANCOVA|||Day 8 analyses||0.70|0.14|
71694733|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.15|0.41|||ANCOVA|||Day 8 analyses||0.41|-0.15|
71694734|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.42|0.14|||ANCOVA|||Day 8 analyses||0.14|-0.42|
71694735|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.61|-0.02|||ANCOVA|||Day 9 analyses||-0.02|-0.61|
71694736|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.53|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.82|-0.23|||ANCOVA|||Day 9 analyses||-0.23|-0.82|
71694737|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.18|0.76|||ANCOVA|||Day 9 analyses||0.76|0.18|
71694738|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.13|0.44|||ANCOVA|||Day 9 analyses||0.44|-0.13|
71694739|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.35|0.23|||ANCOVA|||Day 9 analyses||0.23|-0.35|
71694740|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.29|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.59|0.01|||ANCOVA|||Day 10 analyses||0.01|-0.59|
71694741|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.76|-0.16|||ANCOVA|||Day 10 analyses||-0.16|-0.76|
71694742|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 10 analyses||0.69|0.10|
71694743|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.18|0.41|||ANCOVA|||Day 10 analyses||0.41|-0.18|
71694744|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.36|0.23|||ANCOVA|||Day 10 analyses||0.23|-0.36|
71694745|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.56|0.05|||ANCOVA|||Day 11 analyses||0.05|-0.56|
71694746|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.77|-0.17|||ANCOVA|||Day 11 analyses||-0.17|-0.77|
71694747|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|0.1|0.69|||ANCOVA|||Day 11 analyses||0.69|0.10|
71694748|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.16|0.44|||ANCOVA|||Day 11 analyses||0.44|-0.16|
71942669|NCT00154102|143407030|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.796||||0.0093|TWO_SIDED|95.0|0.67|0.946|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||0.946|0.670|0.0093
71942670|NCT00154102|143407031|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.035||||0.7549|TWO_SIDED|95.0|0.834|1.284|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.284|0.834|0.7549
71942671|NCT00154102|143407032|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.4||||0.0038|TWO_SIDED|95.0|1.12|1.77|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.77|1.12|0.0038
71942672|NCT00154102|143407033|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.069|||<|0.0001|TWO_SIDED|95.0|1.515|2.826|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||2.826|1.515|<0.0001
71942673|NCT00154102|143407034|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.822||||0.3475|TWO_SIDED|95.0|0.544|1.242|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.242|0.544|0.3475
71942674|NCT00154102|143407035|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.92||||0.6004|TWO_SIDED|95.0|0.67|1.26|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\<80 vs. ≥80)||1.26|0.67|0.6004
71942675|NCT00154102|143407037|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.02||||0.002|TWO_SIDED|95.0|1.45|6.27|||Cochran-Mantel-Haenszel|||||6.27|1.45|0.002
71942676|NCT01108094|143407098|OTHER|||||||0.04|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.04
71942677|NCT01108094|143407098|OTHER|||||||0.079|||||||t-test, 1 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."||||0.079
71942678|NCT01108094|143407098|OTHER|||||||0.652|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month."||||0.652
71942679|NCT01108094|143407099|OTHER|||||||0.028|||||||t-test, 2 sided|||"Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment."|Wilcoxon signed rank test|||0.028
71942680|NCT01108094|143407100|OTHER||Mean Difference (Final Values)|24.0|||||TWO_SIDED|95.0|18.2|30.0||||||Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.||30|18.2|
71942681|NCT01108094|143407100|OTHER|||||||0.435|||||||t-test, 1 sided|||Average tumor size reductions were compared between Cohort A1 and Cohort B.||||0.435
71942682|NCT00420303|143407109|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.47||||0.029||95.0|-32.93|-2.01|||ANCOVA|Treatment groups as fixed factors, baseline value as covariate||Comparison of adjusted means||-2.01|-32.93|0.029
71942683|NCT00420303|143407110|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|10.0||||0.02||95.0|1.44|69.26|||Generalized estimating equations (GEE)|Logit link, a binomial distribution and an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors.||||69.26|1.44|0.02
71942684|NCT00420303|143407111|SUPERIORITY_OR_OTHER|||||||0.007|||||||ANCOVA|Treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||||||0.007
71942685|NCT04455633|143407115|SUPERIORITY||LS Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.249||0.007|TWO_SIDED|95.0|-1.16|-0.18|||MMRM model|||Mixed model repeated measures (MMRM) model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.18|-1.16|0.007
71942686|NCT04455633|143407115|SUPERIORITY||LS Mean Difference|-0.55|STANDARD_ERROR_OF_MEAN|0.254||0.03|TWO_SIDED|95.0|-1.06|-0.05|||MMRM model|||MMRM model included fixed effects of treatment, visit, treatment-by-week interaction, the randomization stratum of Baseline pain severity (moderate, severe), and the Baseline ADPS score as a covariate.||-0.05|-1.06|0.030
71942687|NCT04455633|143407116|SUPERIORITY||Difference in Percentage of Responders|9.6||||0.091|TWO_SIDED|95.0|-1.55|20.76|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% confidence interval (CI) are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||20.76|-1.55|0.091
71942688|NCT04455633|143407116|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.883|TWO_SIDED|95.0|-10.95|9.4|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||9.40|-10.95|0.883
71942689|NCT04455633|143407117|SUPERIORITY||Difference in Percentage of Responders|4.8||||0.289|TWO_SIDED|95.0|-4.11|13.73|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||13.73|-4.11|0.289
71942690|NCT04455633|143407117|SUPERIORITY||Difference in Percentage of Responders|-0.8||||0.837|TWO_SIDED|95.0|-8.85|7.16|||Cochran-Mantel-Haenszel|||Percentage of responders were analyzed using the CMH test stratified by the randomization factor of Baseline severity score (moderate, severe). The 95% CI are calculated using the asymptotic Wald method. Missing observations at Week 6 are imputed as nonresponses.||7.16|-8.85|0.837
71942691|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.73|STANDARD_ERROR_OF_MEAN|0.298||0.014|TWO_SIDED|95.0|-1.32|-0.15|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.15|-1.32|0.014
71694749|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.37|0.23|||ANCOVA|||Day 11 analyses||0.23|-0.37|
71942692|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.29||0.017|TWO_SIDED|95.0|-1.27|-0.13|||MMRM model|||Pain at its Worst: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its worst score as a covariate.||-0.13|-1.27|0.017
71942693|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.74|STANDARD_ERROR_OF_MEAN|0.302||0.015|TWO_SIDED|95.0|-1.33|-0.15|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.15|-1.33|0.015
71942694|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.69|STANDARD_ERROR_OF_MEAN|0.294||0.02|TWO_SIDED|95.0|-1.27|-0.11|||MMRM model|||Pain at its Least: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain at its least score as a covariate.||-0.11|-1.27|0.020
71942695|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.87|STANDARD_ERROR_OF_MEAN|0.309||0.005|TWO_SIDED|95.0|-1.48|-0.27|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||-0.27|-1.48|0.005
71942696|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.111|TWO_SIDED|95.0|-1.07|0.11|||MMRM model|||Pain Right Now: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain right now score as a covariate.||0.11|-1.07|0.111
71694750|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.22|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.53|0.09|||ANCOVA|||Day 12 analyses||0.09|-0.53|
71694751|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.46|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.77|-0.15|||ANCOVA|||Day 12 analyses||-0.15|-0.77|
71694752|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.27|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.04|0.57|||ANCOVA|||Day 12 analyses||0.57|-0.04|
71694753|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.15|||TWO_SIDED|95.0|-0.25|0.36|||ANCOVA|||Day 12 analyses||0.36|-0.25|
71694754|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.5|0.11|||ANCOVA|||Day 12 analyses||0.11|-0.50|
71942697|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.26|STANDARD_ERROR_OF_MEAN|0.31||0.399|TWO_SIDED|95.0|-0.87|0.35|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.35|-0.87|0.399
71942698|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.302||0.441|TWO_SIDED|95.0|-0.83|0.36|||MMRM model|||Interference score averaged Over Questions 9A - G: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline pain interference score as a covariate.||0.36|-0.83|0.441
71694755|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.56|0.07|||ANCOVA|||Day 13/Early Termination analyses||0.07|-0.56|
71694756|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.5|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.81|-0.19|||ANCOVA|||Day 13/Early Termination analyses||-0.19|-0.81|
71694757|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.2|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.1|0.51|||ANCOVA|||Day 13/Early Termination analyses||0.51|-0.10|
71694758|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.35|0.26|||ANCOVA|||Day 13/Early Termination analyses||0.26|-0.35|
71942699|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.19|STANDARD_ERROR_OF_MEAN|0.346||0.575|TWO_SIDED|95.0|-0.87|0.49|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.49|-0.87|0.575
71942700|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.337||0.88|TWO_SIDED|95.0|-0.71|0.61|||MMRM model|||General Activity: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline general activity score as a covariate.||0.61|-0.71|0.880
71694759|NCT00549549|142904316|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.16|||TWO_SIDED|95.0|-0.6|0.01|||ANCOVA|||Day 13/Early Termination analyses||0.01|-0.60|
71694760|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.28|0.14|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.14|-0.28|
71694761|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.18|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.39|0.03|||ANCOVA|||Day 1, 2 hours postdose||0.03|-0.39|
71694762|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.31|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.11|0.52|||ANCOVA|||Day 1, 2 hours postdose||0.52|0.11|
71694763|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.24|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.04|0.45|||ANCOVA|||Day 1, 2 hours postdose||0.45|0.04|
71694764|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.13|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.34|||ANCOVA|||Day 1, 2 hours postdose||0.34|-0.08|
71694765|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.37|0.08|||ANCOVA|||Day 1, 4 hours postdose||0.08|-0.37|
71694766|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.48|-0.03|||ANCOVA|||Day 1, 4 hours postdose||-0.03|-0.48|
71694767|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.36|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.14|0.58|||ANCOVA|||Day 1, 4 hours postdose||0.58|0.14|
71694768|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.0|0.44|||ANCOVA|||Day 1, 4 hours postdose||0.44|0.00|
71694769|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.11|0.34|||ANCOVA|||Day 1, 4 hours postdose||0.34|-0.11|
71694770|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.32|0.17|||ANCOVA|||Day 1, 8 hours postdose||0.17|-0.32|
71694771|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.56|-0.06|||ANCOVA|||Day 1, 8 hours postdose||-0.06|-0.56|
71694772|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.18|0.67|||ANCOVA|||Day 1, 8 hours postdose||0.67|0.18|
71694773|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.35|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|0.11|0.59|||ANCOVA|||Day 1, 8 hours postdose||0.59|0.11|
71694774|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.13|0.36|||ANCOVA|||Day 1, 8 hours postdose||0.36|-0.13|
71694775|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.16|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.42|0.1|||ANCOVA|||Day 1, 12 hours postdose||0.10|-0.42|
71694776|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.37|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.63|-0.11|||ANCOVA|||Day 1, 12 hours postdose||-0.11|-0.63|
71694777|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.19|0.7|||ANCOVA|||Day 1, 12 hours postdose||0.70|0.19|
71694778|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.03|0.55|||ANCOVA|||Day 1, 12 hours postdose||0.55|0.03|
71694779|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.18|0.34|||ANCOVA|||Day 1, 12 hours postdose||0.34|-0.18|
71694780|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.46|0.07|||ANCOVA|||Day 2, 0 hours postdose||0.07|-0.46|
71694781|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.57|-0.04|||ANCOVA|||Day 2, 0 hours postdose||-0.04|-0.57|
71694782|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.42|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.16|0.68|||ANCOVA|||Day 2, 0 hours postdose||0.68|0.16|
71694783|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.04|0.49|||ANCOVA|||Day 2, 0 hours postdose||0.49|-0.04|
71942701|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.368||0.978|TWO_SIDED|95.0|-0.73|0.71|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.71|-0.73|0.978
71942702|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|0.06|STANDARD_ERROR_OF_MEAN|0.358||0.877|TWO_SIDED|95.0|-0.65|0.76|||MMRM model|||Mood: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline mood score as a covariate.||0.76|-0.65|0.877
71694784|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|-0.15|0.38|||ANCOVA|||Day 2, 0 hours postdose||0.38|-0.15|
71694785|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.13|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.4|0.14|||ANCOVA|||Day 2, 8 hours postdose||0.14|-0.40|
71694786|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.59|-0.05|||ANCOVA|||Day 2, 8 hours postdose||-0.05|-0.59|
71694787|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.47|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|0.2|0.74|||ANCOVA|||Day 2, 8 hours postdose||0.74|0.20|
71694788|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.13|||TWO_SIDED|95.0|0.08|0.61|||ANCOVA|||Day 2, 8 hours postdose||0.61|0.08|
71694789|NCT00549549|142904317|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.14|||TWO_SIDED|95.0|-0.11|0.42|||ANCOVA|||Day 2, 8 hours postdose||0.42|-0.11|
71694790|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Median Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.09|0.27|||ANCOVA|||8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.27|-0.09|
71694791|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|0.04|0.4|||ANCOVA|||8 hour postdose analysis||0.40|0.04|
71942703|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.354||0.079|TWO_SIDED|95.0|-1.32|0.07|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.07|-1.32|0.079
71942704|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.345||0.163|TWO_SIDED|95.0|-1.16|0.2|||MMRM model|||Walking Ability: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline walking ability score as a covariate.||0.20|-1.16|0.163
71942705|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.05|STANDARD_ERROR_OF_MEAN|0.344||0.875|TWO_SIDED|95.0|-0.73|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.73|0.875
71942706|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.335||0.914|TWO_SIDED|95.0|-0.69|0.62|||MMRM model|||Normal Work: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline normal work score as a covariate.||0.62|-0.69|0.914
71942707|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|0.351||0.219|TWO_SIDED|95.0|-0.26|1.12|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||1.12|-0.26|0.219
71942708|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|0.2|STANDARD_ERROR_OF_MEAN|0.341||0.551|TWO_SIDED|95.0|-0.47|0.87|||MMRM model|||Relations with Other People: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline relations with other people score as a covariate.||0.87|-0.47|0.551
71942709|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.96|STANDARD_ERROR_OF_MEAN|0.339||0.005|TWO_SIDED|95.0|-1.63|-0.3|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.30|-1.63|0.005
71942710|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-1.04|STANDARD_ERROR_OF_MEAN|0.329||0.002|TWO_SIDED|95.0|-1.68|-0.39|||MMRM model|||Sleep: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline sleep score as a covariate.||-0.39|-1.68|0.002
71942711|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.361||0.955|TWO_SIDED|95.0|-0.73|0.69|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.69|-0.73|0.955
71942712|NCT04455633|143407118|SUPERIORITY||LS Mean Difference|-0.1|STANDARD_ERROR_OF_MEAN|0.351||0.777|TWO_SIDED|95.0|-0.79|0.59|||MMRM model|||Enjoyment of Life: change from baseline was analyzed using MMRM model including fixed effects of treatment, visit, treatment-by-visit interaction, the randomization stratum of baseline pain severity (moderate, severe), and the baseline enjoyment of life score as a covariate.||0.59|-0.79|0.777
71942713|NCT04455633|143407120|SUPERIORITY||LS Mean Difference|-0.35|STANDARD_ERROR_OF_MEAN|0.163||0.031|TWO_SIDED|95.0|-0.67|-0.03|||ANOVA|||Analysis of variance (ANOVA) model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||-0.03|-0.67|0.031
71942714|NCT04455633|143407120|SUPERIORITY||LS Mean Difference|-0.15|STANDARD_ERROR_OF_MEAN|0.165||0.351|TWO_SIDED|95.0|-0.48|0.17|||ANOVA|||ANOVA model was used for the analysis with treatment and the randomization stratum of baseline pain severity (moderate, severe) as fixed covariates.||0.17|-0.48|0.351
71942715|NCT01027780|143407150|SUPERIORITY_OR_OTHER|||||||0.007||95.0||||Please note that this analysis tested the differences between groups following the intervention.|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.007
71942716|NCT01027780|143407151|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||Note that this is the p value for differences between groups immediately following the intervention|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.||||||.04
71942717|NCT01027780|143407152|SUPERIORITY_OR_OTHER|||||||0.03||95.0||||Difference between groups following intervention|ANOVA|||||||.03
71942718|NCT01029353|143407177|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.87|1.14|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates.||1.14|0.87|
71942719|NCT01029353|143407177|OTHER|||||||0.03||||||Pre-specified threshold = 0.05|Robust Poisson regression|||A frequentist analysis. Using Robust Poisson regression with log link and center as repeated measure, and effect coding, test for an interaction between treatment (Initial Laparotomy/Initial Peritoneal Drain) and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) as covariates. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-operative diagnosis as covariates.||||0.03
71694792|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.32|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.5|-0.14|||ANCOVA|||8 hour postdose analysis||-0.14|-0.50|
71694793|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.23|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.41|-0.05|||ANCOVA|||8 hour postdose analysis||-0.05|-0.41|
71694794|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.09|||TWO_SIDED|95.0|-0.28|0.08|||ANCOVA|||8 hour postdose analysis||0.08|-0.28|
71942720|NCT01029353|143407177|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.82, 1.11).|||
71942721|NCT01029353|143407177|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.75|1.26|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariate.|A frequentist analysis. Model included treatment, baseline risk of death or NDI, and pre-operative diagnosis (Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP)) covariates.||1.26|0.75|
71942722|NCT01029353|143407178|SUPERIORITY||Risk Ratio (RR)|1.0|||||TWO_SIDED|95.0|0.69|1.45|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.45|0.69|
71942723|NCT01029353|143407178|SUPERIORITY|A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|||||||||||||||||Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.69, 1.30).|||
71942724|NCT01029353|143407179|SUPERIORITY||Risk Ratio (RR)|1.02|||||TWO_SIDED|95.0|0.78|1.34|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis. Estimate based on model fit using only data from study survivors.||1.34|0.78|
71942725|NCT01029353|143407179|SUPERIORITY|||||||||||||||||A Bayesian analysis among study survivors. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.99, 95% credible interval of (0.78, 1.25).|||
71942726|NCT01029353|143407180|SUPERIORITY||Risk Ratio (RR)|0.83|||||TWO_SIDED|95.0|0.66|1.06|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.06|0.66|
71942727|NCT01029353|143407180|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.65, 1.02).|||
71694795|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.1|0.29|||ANCOVA|||12 hour postdose analysis||0.29|-0.10|
71694796|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|0.06|0.45|||ANCOVA|||12 hour postdose analysis||0.45|0.06|
71694797|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.55|-0.16|||ANCOVA|||12 hour postdose analysis||-0.16|-0.55|
71694798|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.45|-0.07|||ANCOVA|||12 hour postdose analysis||-0.07|-0.45|
71694799|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1|||TWO_SIDED|95.0|-0.29|0.09|||ANCOVA|||12 hour postdose analysis||0.09|-0.29|
71694800|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.08|0.35|||ANCOVA|||24 hour postdose analysis||0.35|-0.08|
71694801|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|0.08|0.51|||ANCOVA|||24 hour postdose analysis||0.51|0.08|
71694802|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.61|-0.18|||ANCOVA|||24 hour postdose analysis||-0.18|-0.61|
71694803|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.47|-0.05|||ANCOVA|||24 hour postdose analysis||-0.05|-0.47|
71694804|NCT00549549|142904318|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.32|0.11|||ANCOVA|||24 hour postdose analysis||0.11|-0.32|
71694805|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0459|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||||0.0459
71694806|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0017
71694807|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0001
71694808|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.041|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.0410
71694809|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=30% reduction analyses||||0.5592
71694810|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0277|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0277
71694811|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0018|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0018
71694812|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||<.0001
71694813|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0394|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.0394
71694814|NCT00549549|142904319|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4603|TWO_SIDED||||||Cochran-Mantel-Haenszel|||\>=50% reduction analyses||||0.4603
71694815|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5528|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5528
71694816|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1779|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1779
71694817|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1754|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1754
71694818|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3384|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.3384
71694819|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5005|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5005
71694820|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0845|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0845
71694821|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0213|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0213
71694822|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1231|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1231
71694823|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6636|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.6636
71694824|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5378|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.5378
71694825|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0818|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0818
71694826|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0317|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.0317
71694827|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1592|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.1592
71694828|NCT00549549|142904322|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7956|TWO_SIDED||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1 or \>1\]) and region.||||0.7956
71694829|NCT00549549|142904323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.17|0.31|||ANCOVA|||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient's Assessment of Pain Intensity at Baseline as a covariate.||0.31|-0.17|
71694830|NCT00549549|142904323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|0.22|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.02|0.46|||ANCOVA|||||0.46|-0.02|
71694831|NCT00549549|142904323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.26|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.5|-0.02|||ANCOVA|||||-0.02|-0.50|
71694832|NCT00549549|142904323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.19|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.43|0.05|||ANCOVA|||||0.05|-0.43|
71694833|NCT00549549|142904323|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.12|||TWO_SIDED|95.0|-0.28|0.19|||ANCOVA|||||0.19|-0.28|
71694834|NCT00549549|142904324|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3173|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.3173
71694835|NCT00549549|142904325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4724|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.4724
71694836|NCT00549549|142904325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
71694837|NCT00549549|142904325|SUPERIORITY_OR_OTHER_LEGACY|||||||0.7316|TWO_SIDED||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints \[1; \>1\], and region.||||0.7316
71694838|NCT02688933|142904347|SUPERIORITY||Least Square mean difference|0.22|STANDARD_ERROR_OF_MEAN|1.15||0.8494|TWO_SIDED|||||Threshold for significance at 0.05 level.|Generalized linear model|Generalized linear model with identity link||Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening \[\<8.0% vs ≥8.0%\], frequency of Lantus injection at screening, current CGM use \[yes/no\], and mealtime insulin titration algorithm).||||0.8494
71942728|NCT01029353|143407181|SUPERIORITY||Risk Ratio (RR)|1.03|||||TWO_SIDED|95.0|0.89|1.18|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.18|0.89|
71694839|NCT00248651|142904355|SUPERIORITY_OR_OTHER|||||||0.05|||||||ANCOVA|||Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of \<0.05 was considered statistically significant.||||0.05
71694840|NCT00248651|142904358|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|||Comparison between antidepressant arms and placebo for overall quality of life. A p-value of \<0.05 was considered statistically significant.||||0.02
71694841|NCT00248651|142904358|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
71694842|NCT00248651|142904358|SUPERIORITY_OR_OTHER|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Interference subscale. A p-value of \<0.05 was considered statistically significant.||||0.06
71694843|NCT00248651|142904358|SUPERIORITY_OR_OTHER|||||||0.01|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of \<0.05 was considered statistically significant.||||0.01
71694844|NCT00248651|142904358|SUPERIORITY_OR_OTHER|||||||0.04|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of \<0.05 was considered statistically significant.||||0.04
71694845|NCT01275144|142904359|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|0.897|||||TWO_SIDED|90.0|0.86|0.94|||||Ratio of LY2216684 to Placebo|||0.94|0.86|
71694846|NCT01275144|142904360|SUPERIORITY_OR_OTHER||median of paired differences|0.5||||0.0021|TWO_SIDED|90.0|0.5|1.0|||Wilcoxon signed rank test||Ratio of LY2216684 to Placebo|||1.00|0.50|0.0021
71694847|NCT01275144|142904361|SUPERIORITY_OR_OTHER||Ratio of geometric least square mean|1.04|||||TWO_SIDED|90.0|1.01|1.08|||||Ratio of LY2216684 to Placebo|||1.08|1.01|
71694848|NCT04622969|142904394|SUPERIORITY||Mean Difference (Net)|-21.6|STANDARD_ERROR_OF_MEAN|5.157|<|0.001|TWO_SIDED||||||ANCOVA|||||||<.001
71694849|NCT04622969|142904396|SUPERIORITY||Mean Difference (Net)|7.12|STANDARD_ERROR_OF_MEAN|12.05|=|0.56|TWO_SIDED||||||Mixed Models Analysis|||||||=0.56
71694850|NCT04622969|142904400|SUPERIORITY||Mean Difference (Net)|0.0015|STANDARD_ERROR_OF_MEAN|0.145|=|0.99|TWO_SIDED||||||Mixed Models Analysis|||||||=0.99
71694851|NCT04622969|142904402|SUPERIORITY||Mean Difference (Net)|-0.264|STANDARD_ERROR_OF_MEAN|0.121|<|0.05|TWO_SIDED||||||ANCOVA|||||||<.05
71694852|NCT04622969|142904404|SUPERIORITY||Mean Difference (Net)|-5.573|STANDARD_ERROR_OF_MEAN|1.802|<|0.01|TWO_SIDED||||||ANCOVA|||||||<.01
71694853|NCT04622969|142904406|SUPERIORITY||Mean Difference (Net)|3.509|STANDARD_ERROR_OF_MEAN|1.842|=|0.062|TWO_SIDED||||||ANCOVA|||||||=.062
71694854|NCT04622969|142904406|SUPERIORITY||Mean Difference (Net)|0.047|STANDARD_ERROR_OF_MEAN|0.17|=|0.78|TWO_SIDED||||||Mixed Models Analysis|||||||=0.78
71694855|NCT05607576|142904407|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values blood glucose readings (mg/dL) were grouped based on radiation exposure (\>0-500 µGy and \>500 µGy). A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects were used to assess absolute differences in BG mg/dL by cumulative scatter||||||<0.05
71694856|NCT05607576|142904408|OTHER|Clarke error grid analyses (EGA) were performed to compare CGM values to glucometer glucose values. A p-value \<0.05 was considered statistically significant.|||||<|0.05|||||||Mixed Models Analysis|Generalized linear mixed models with random effects over time were used to assess absolute differences in BG mg/dL by time||||||<0.05
71694857|NCT03834506|142904424|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.1677|TWO_SIDED|95.0|0.78|1.09||One-sided p-value based on log-rank test stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||1.09|0.78|0.1677
71694858|NCT03834506|142904425|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0335|TWO_SIDED|95.0|0.71|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.71|0.0335
71694859|NCT03834506|142904426|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0331|TWO_SIDED|95.0|0.74|1.01||One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|Log Rank||HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.01|0.74|0.0331
71694860|NCT03834506|142904428|OTHER||Percent Difference|-1.8||||0.6545|TWO_SIDED|95.0|-10.7|7.1||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|Miettinen & Nurminen method||Based on Miettinen \& Nurminen method stratified by prior treatment with a NHA (abiraterone acetate) and type of metastases at baseline.|||7.1|-10.7|0.6545
71694861|NCT03834506|142904430|OTHER||Hazard Ratio (HR)|1.05||||0.6178|TWO_SIDED|95.0|0.77|1.43|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.43|0.77|0.6178
71694862|NCT03834506|142904431|OTHER||Hazard Ratio (HR)|1.54||||0.9788|TWO_SIDED|95.0|1.01|2.33|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||2.33|1.01|0.9788
71694863|NCT03834506|142904432|OTHER||Hazard Ratio (HR)|0.96||||0.297|TWO_SIDED|95.0|0.82|1.12|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.12|0.82|0.2970
71942729|NCT01029353|143407181|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.98, 95% credible interval of (0.84, 1.15).|||
71694864|NCT03834506|142904433|OTHER||Hazard Ratio (HR)|0.95||||0.2876|TWO_SIDED|95.0|0.78|1.15|||Log Rank|One-sided p-value based on log-rank test stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by prior treatment with NHA (abiraterone acetate) and type of metastases at baseline.|||1.15|0.78|0.2876
71694865|NCT04391842|142904444|OTHER||||||<|0.001|||||||ANOVA|||||||<0.001
71694866|NCT04391842|142904445|OTHER||||||<|0.001|||||||t-test, 1 sided|||||||<0.001
71694867|NCT00810199|142904446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.26||||0.2055|TWO_SIDED|95.0|0.882|1.799||Cochran-Mantel-Haenszel test stratified by region and baseline DAS28 (≤5.5 and \>5.5).|Cochran-Mantel-Haenszel|||||1.799|0.882|0.2055
71694868|NCT00810199|142904446|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.27||||0.1894|TWO_SIDED|95.0|0.889|1.814||Logistic regression including treatment , region and baseline DAS28.|Regression, Logistic|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.||||1.814|0.889|0.1894
71694869|NCT00810199|142904447|SUPERIORITY_OR_OTHER|||||||0.8742||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8742
71694870|NCT00810199|142904447|SUPERIORITY_OR_OTHER|||||||0.6212||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6212
71694871|NCT00810199|142904447|SUPERIORITY_OR_OTHER|||||||0.0963||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.0963
71694872|NCT00810199|142904448|SUPERIORITY_OR_OTHER|||||||0.2969||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.2969
71694873|NCT00810199|142904448|SUPERIORITY_OR_OTHER|||||||0.2215||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.2215
71694874|NCT00810199|142904448|SUPERIORITY_OR_OTHER|||||||0.1243||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.1243
71942730|NCT01029353|143407182|SUPERIORITY||Risk Ratio (RR)|0.92|||||TWO_SIDED|95.0|0.64|1.31|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.31|0.64|
71694875|NCT00810199|142904449|SUPERIORITY_OR_OTHER|||||||0.6775||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.6775
71694876|NCT00810199|142904449|SUPERIORITY_OR_OTHER|||||||0.9976||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.9976
71942731|NCT01029353|143407182|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.86, 95% credible interval of (0.64, 1.16).|||
71942732|NCT01029353|143407183|SUPERIORITY||Risk Ratio (RR)|0.97|||||TWO_SIDED|95.0|0.69|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.69|
71694877|NCT00810199|142904449|SUPERIORITY_OR_OTHER|||||||0.2168||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2168
71694878|NCT00810199|142904450|SUPERIORITY_OR_OTHER|||||||0.8369||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.8369
71694879|NCT00810199|142904450|SUPERIORITY_OR_OTHER|||||||0.6528||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.6528
71694880|NCT00810199|142904450|SUPERIORITY_OR_OTHER|||||||0.2546||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 104||||0.2546
71694881|NCT00810199|142904451|SUPERIORITY_OR_OTHER|||||||0.1018|||||||Log Rank|||||||0.1018
71694882|NCT00810199|142904452|SUPERIORITY_OR_OTHER|||||||0.7176|||||||Log Rank|||||||0.7176
71694883|NCT00810199|142904453|SUPERIORITY_OR_OTHER|||||||0.8526|||||||Log Rank|||||||0.8526
71694884|NCT00810199|142904454|SUPERIORITY_OR_OTHER|||||||0.2217|||||||Log Rank|||||||0.2217
71694885|NCT00810199|142904455|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.0008|TWO_SIDED|95.0|-0.41|-0.11|||ANCOVA|Baseline DAS28 as a covariate.||||-0.11|-0.41|0.0008
71694886|NCT00810199|142904456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.49||||0.0245|TWO_SIDED|95.0|1.053|2.109|||Regression, Logistic|Logistic regression including treatment, region and baseline DAS28.|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.|||2.109|1.053|0.0245
71694887|NCT00810199|142904456|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.482||||0.0258||95.0|1.048|2.095||Stratified by region and baseline DAS28 (≤ 5.5 and \> 5.5).|Cochran-Mantel-Haenszel|||||2.095|1.048|0.0258
71694888|NCT00810199|142904457|SUPERIORITY_OR_OTHER|||||||0.0287||95.0|||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 24||||0.0287
71694889|NCT00810199|142904457|SUPERIORITY_OR_OTHER|||||||0.224|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 52||||0.2240
71694890|NCT00810199|142904458|SUPERIORITY_OR_OTHER|||||||0.0497||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.0497
71694891|NCT00810199|142904458|SUPERIORITY_OR_OTHER|||||||0.3918|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.3918
71694892|NCT00810199|142904459|SUPERIORITY_OR_OTHER|||||||0.0019||95.0|||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 24||||0.0019
71694893|NCT00810199|142904459|SUPERIORITY_OR_OTHER|||||||0.1181|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and \>5.5) included as stratification variables.||Week 52||||0.1181
71694894|NCT00810199|142904460|SUPERIORITY_OR_OTHER|||||||0.7776||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.7776
71694895|NCT00810199|142904460|SUPERIORITY_OR_OTHER|||||||0.8843|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8843
71694896|NCT00810199|142904461|SUPERIORITY_OR_OTHER|||||||0.9095||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9095
71694897|NCT00810199|142904461|SUPERIORITY_OR_OTHER|||||||0.7179|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7179
71694898|NCT00810199|142904462|SUPERIORITY_OR_OTHER|||||||0.3113||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.3113
71694899|NCT00810199|142904462|SUPERIORITY_OR_OTHER|||||||0.2931||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.2931
71694900|NCT00810199|142904463|SUPERIORITY_OR_OTHER|||||||0.2451||95.0||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24||||0.2451
71694901|NCT00810199|142904463|SUPERIORITY_OR_OTHER|||||||0.8841||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.8841
71694902|NCT00810199|142904464|SUPERIORITY_OR_OTHER|||||||0.9655||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9655
71694903|NCT00810199|142904464|SUPERIORITY_OR_OTHER|||||||0.0308||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.0308
71694904|NCT00810199|142904465|SUPERIORITY_OR_OTHER|||||||0.5186||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.5186
71694905|NCT00810199|142904465|SUPERIORITY_OR_OTHER|||||||0.7706||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.7706
71694906|NCT00810199|142904466|SUPERIORITY_OR_OTHER|||||||0.6067||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.6067
71694907|NCT00810199|142904466|SUPERIORITY_OR_OTHER|||||||0.681||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.6810
71694908|NCT00810199|142904467|SUPERIORITY_OR_OTHER|||||||0.9323||95.0|||||Wilcoxon (Mann-Whitney)|||Week 24||||0.9323
71694909|NCT00810199|142904467|SUPERIORITY_OR_OTHER|||||||0.1448||95.0|||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1448
71694910|NCT00810199|142904468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.2034|TWO_SIDED|95.0|-0.43|0.09||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.09|-0.43|0.2034
71694911|NCT00810199|142904468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.3611|TWO_SIDED|95.0|-0.88|0.32||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.32|-0.88|0.3611
71694912|NCT00810199|142904468|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.0342|TWO_SIDED|95.0|-1.16|-0.05||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.05|-1.16|0.0342
71694913|NCT00810199|142904469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.7095|TWO_SIDED|95.0|-0.23|0.16||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||0.16|-0.23|0.7095
71694914|NCT00810199|142904469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.8147|TWO_SIDED|95.0|-0.45|0.57||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||0.57|-0.45|0.8147
71694915|NCT00810199|142904469|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.0778|TWO_SIDED|95.0|-0.67|0.04||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||0.04|-0.67|0.0778
71694916|NCT00810199|142904470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.0441|TWO_SIDED|95.0|-0.25|0.0||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24||-0.00|-0.25|0.0441
71694917|NCT00810199|142904470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.0012|TWO_SIDED|95.0|-0.54|-0.13||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52||-0.13|-0.54|0.0012
71694918|NCT00810199|142904470|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.29||||0.0372|TWO_SIDED|95.0|-0.56|-0.02||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104||-0.02|-0.56|0.0372
71694919|NCT00810199|142904471|SUPERIORITY_OR_OTHER||Difference|6.75||||0.0694|TWO_SIDED|95.0|-1.02|14.52|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||Week 52||14.52|-1.02|0.0694
71694920|NCT00810199|142904471|SUPERIORITY_OR_OTHER|||||||0.1695|TWO_SIDED||||||Log Rank|||Week 104||||0.1695
71694921|NCT00810199|142904472|SUPERIORITY_OR_OTHER||Difference|-2.91||||0.0496||95.0|-5.86|0.05|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||0.05|-5.86|0.0496
71694922|NCT00810199|142904473|SUPERIORITY_OR_OTHER||Difference|-1.48||||0.5188|TWO_SIDED|95.0|-6.59|3.62|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and \> 5.5).||||3.62|-6.59|0.5188
71694923|NCT00810199|142904474|SUPERIORITY_OR_OTHER|||||||0.2652|||||||Wilcoxon (Mann-Whitney)|||Week 24||||0.2652
71694924|NCT00810199|142904474|SUPERIORITY_OR_OTHER|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||Week 52||||0.1970
71694925|NCT00810199|142904474|SUPERIORITY_OR_OTHER|||||||0.1671|||||||Wilcoxon (Mann-Whitney)|||||||0.1671
71694926|NCT00810199|142904476|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|5.22||||0.111|TWO_SIDED|95.0|-1.2|11.64|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||11.64|-1.20|0.1110
71694927|NCT00810199|142904477|SUPERIORITY_OR_OTHER||Adjusted Mean Difference (Wald CI)|-2.11||||0.6027|TWO_SIDED|95.0|-10.07|5.85|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and \> 5.5) as fixed factors.||||5.85|-10.07|0.6027
71694928|NCT00810199|142904478|SUPERIORITY_OR_OTHER|||||||0.1695|||||||Log Rank|||||||0.1695
71694929|NCT00810199|142904479|SUPERIORITY_OR_OTHER|||||||0.0096|||||||Log Rank|||||||0.0096
71694930|NCT00810199|142904480|SUPERIORITY_OR_OTHER|||||||0.0734|||||||Log Rank|||||||0.0734
71694931|NCT01091246|142904482|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5.|Ratio of geometric mean|1.07|||||TWO_SIDED|95.0|0.98|1.16|||Bootstrapping|||A/H1N1: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H1N1 strain||1.16|0.98|
71694932|NCT01091246|142904482|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric means|1.04|||||TWO_SIDED|95.0|0.94|1.14|||Bootstrapping|||A/H3N2: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H3N2 strain||1.14|0.94|
71694933|NCT01091246|142904482|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.21|||||TWO_SIDED|95.0|1.07|1.37||||||B/Yamagata: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata) / (Q/LAIV) for B/Yamagata strain||1.37|1.07|
71694934|NCT01091246|142904482|NON_INFERIORITY_OR_EQUIVALENCE|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% confidence intervals were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.05|||||TWO_SIDED|95.0|0.93|1.18||||||B/Victoria: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj \> 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Victoria) / (Q/LAIV) for B/Victoria strain||1.18|0.93|
71694935|NCT02731300|142904518|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
71694936|NCT02731300|142904519|SUPERIORITY_OR_OTHER||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups||||<0.05
71694937|NCT02713178|142904520|SUPERIORITY||LSMD|-20.249||||0.4463|TWO_SIDED|95.0|-72.361|31.864|||ANOVA|||||31.864|-72.361|0.4463
71694938|NCT02713178|142904520|SUPERIORITY||LSMD|-28.796||||0.2749|TWO_SIDED|95.0|-80.483|22.892|||ANOVA|||||22.892|-80.483|0.2749
71694939|NCT02713178|142904521|SUPERIORITY||LSM treatment ratio|0.853||||0.0716|TWO_SIDED|95.0|0.717|1.014|||ANOVA|||||1.014|0.717|0.0716
71694940|NCT02713178|142904521|SUPERIORITY||LSM treatment ratio|0.913||||0.3004|TWO_SIDED|95.0|0.769|1.084|||ANOVA|||||1.084|0.769|0.3004
71694941|NCT02713178|142904523|SUPERIORITY|||||||0.1896|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.1896
71694942|NCT02713178|142904523|SUPERIORITY|||||||0.2549|||||||Log Rank|||The overall distribution as estimated by the Kaplan-Meier analysis was compared between the EXPAREL arm and the placebo arm.||||0.2549
71694943|NCT00596271|142904528|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. IC51+Placebo group in terms of the GMT for anti- JEV neutralizing antibody at day 56. An observed cases approach will be applied for the primary analysis||||<0.0001
71761153|NCT01262989|143023957|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.79||||||90.0|96.99|108.93|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||108.93|96.99|
71942733|NCT01029353|143407183|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.92, 95% credible interval of (0.68, 1.25).|||
71942734|NCT01029353|143407184|SUPERIORITY||Risk Ratio (RR)|0.47|||||TWO_SIDED|95.0|0.35|0.63|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.63|0.35|
71942735|NCT01029353|143407184|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.51, 95% credible interval of (0.37, 0.69).|||
71942736|NCT01029353|143407185|SUPERIORITY||Risk Ratio (RR)|1.57|||||TWO_SIDED|95.0|1.04|2.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.36|1.04|
71942737|NCT01029353|143407185|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.45, 95% credible interval of (0.92, 2.31).|||
71942738|NCT01029353|143407186|SUPERIORITY||Risk Ratio (RR)|1.58|||||TWO_SIDED|95.0|0.71|3.5|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||3.50|0.71|
71694944|NCT00596271|142904532|NON_INFERIORITY_OR_EQUIVALENCE|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are \> 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio \> 0.5."|||||<|0.0001||95.0|||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. HAVRIX+Placebo group in terms of the GMT for HAV antibody at day 28. An observed cases approach will be applied for the primary analysis.||||<0.0001
71694945|NCT00689338|142904583|SUPERIORITY_OR_OTHER||estimate of survival|53.8|||||TWO_SIDED|95.0|45.9|60.9|||Kaplan-Meier|||Kaplan-Meier estimate of survival at Day 90 (survivor function).||60.9|45.9|
71694946|NCT00078286|142904660|NON_INFERIORITY_OR_EQUIVALENCE|\*Power analysis already provided.|Difference in mean change score|-0.3||||0.89||95.0|||||Mixed Models Analysis|Significance was tested at p=.05.||A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.||||0.89
71694947|NCT00078286|142904661|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.08||||0.78||95.0|||||Cochran-Mantel-Haenszel|||Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.||||.78
71694948|NCT02175225|142904662|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.006|||||ONE_SIDED|90.0||0.068|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.068||
71694949|NCT02175225|142904663|OTHER||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.57|1.16||||||||1.16|0.57|
71694950|NCT02175225|142904664|OTHER||Risk Ratio (RR)|0.94|||||TWO_SIDED|95.0|0.57|1.56||||||||1.56|0.57|
71694951|NCT02175225|142904665|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than13% in favor of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.062|||||ONE_SIDED|90.0||0.121|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference\[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.121||
71694952|NCT02175225|142904666|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.086|||||ONE_SIDED|90.0||0.156|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.156||
71694953|NCT02175225|142904667|OTHER|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if the upper bound on the risk difference was less than 13% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|-0.018|||||ONE_SIDED|90.0||0.029|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference \[AARD\]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.|||0.029||
71694954|NCT02175225|142904668|OTHER|||||||0.83||||||The p value reflects the significance of the interaction term between treatment and onset to treatment time.|Regression, Logistic|||||||0.83
71694955|NCT02175225|142904669|OTHER||Odds Ratio (OR)|1.1|||||TWO_SIDED|95.0|0.72|1.67|||||The estimation parameter is the adjusted common odds ratio.|||1.67|0.72|
71942739|NCT01029353|143407186|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.31, 95% credible interval of (0.66, 2.62).|||
71694956|NCT02175225|142904670|OTHER||Odds Ratio, log|1.26|||||TWO_SIDED|95.0|0.82|1.93||||||||1.93|0.82|
71694957|NCT02175225|142904673|OTHER||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.0|14.97|||||Confidence interval is exact (rather than asymptotic) due to small number of events.|||14.97|0.0|
71694958|NCT02175225|142904674|OTHER||Risk Ratio (RR)|0.89|||||TWO_SIDED|95.0|0.51|1.54|||||Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.|||1.54|0.51|
71694959|NCT02175225|142904675|OTHER||Risk Ratio (RR)|1.84|||||TWO_SIDED|95.0|0.63|5.35||||||||5.35|0.63|
71694960|NCT01409239|142904684|SUPERIORITY_OR_OTHER|||||||0.05||||||Wilcoxon rank-sum was used to determine differences between groups.|Wilcoxon (Mann-Whitney)|||Since this was a pilot study no formal power analysis was possible. It was hypothesized that IV insulin would be associated with lower LF/HF HRV.||||0.05
71942740|NCT01029353|143407187|SUPERIORITY|||||||||||||||||A frequentist analysis.|This analysis used model identical to other by treatment analyses for binary outcome. RR estimated from robust Poisson regression with log link, reference cell coding, center as repeated measure. RR: Initial Laparotomy over Peritoneal Drain. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates. However, adjusted RR estimates could not be calculated due to the iteration limit being excessed in PROC GENMOD.|||
71942741|NCT01029353|143407187|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.16, 95% credible interval of (0.50, 2.65).|||
71942742|NCT01029353|143407188|SUPERIORITY||Risk Ratio (RR)|0.86|||||TWO_SIDED|95.0|0.34|2.2|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.20|0.34|
71942743|NCT01029353|143407188|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.93, 95% credible interval of (0.45, 1.91).|||
71942744|NCT01029353|143407189|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.37|1.42|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.42|0.37|
71942745|NCT01029353|143407189|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.75, 95% credible interval of (0.48, 1.16).|||
71694961|NCT01386606|142904691|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||P-value of treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||||0.056
71694962|NCT01386606|142904691|SUPERIORITY_OR_OTHER||Regression Coefficient|-45.77||||0.436|TWO_SIDED|95.0|-143.5|51.98||P-value for Androxal 25 mg treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||51.98|-143.5|0.436
71694963|NCT01386606|142904691|SUPERIORITY_OR_OTHER||Regression Coefficient|-110.9||||0.068|TWO_SIDED|95.0|-210.6|-11.23||P-value for Androxal 12.5 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-11.23|-210.6|0.068
71942746|NCT01029353|143407190|SUPERIORITY||Risk Ratio (RR)|0.9|||||TWO_SIDED|95.0|0.7|1.15|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.15|0.70|
71694964|NCT01386606|142904691|SUPERIORITY_OR_OTHER||Regression Coefficient|-148.5||||0.011|TWO_SIDED|95.0|-242.9|-54.05||P-value for Androxal 6.25 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||-54.05|-242.9|0.011
71694965|NCT01386606|142904691|SUPERIORITY_OR_OTHER||Regression Coefficient|0.58|||<|0.001|TWO_SIDED|95.0|0.37|0.79||P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."||0.79|0.37|<0.001
71694966|NCT01386606|142904692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.||||<0.001
71694967|NCT01386606|142904692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.||||<0.001
71694968|NCT01386606|142904692|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.||||<0.001
71694969|NCT01386606|142904693|SUPERIORITY_OR_OTHER||Pearson Correlation|0.90993|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.||||<0.0001
71694970|NCT01386606|142904693|SUPERIORITY_OR_OTHER||Pearson Correlation|0.86541|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.||||<0.0001
71694971|NCT01386606|142904693|SUPERIORITY_OR_OTHER||Pearson Correlation|0.89643|||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.||||<0.0001
71694972|NCT01386606|142904695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.||||<0.001
71942747|NCT01029353|143407190|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.91, 95% credible interval of (0.65, 1.27).|||
71694973|NCT01386606|142904695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.||||<0.001
71694974|NCT01386606|142904695|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.||||<0.001
71694975|NCT01022203|142904706|SUPERIORITY_OR_OTHER||Slope|0.0001|||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.0001
71694976|NCT01022203|142904707|SUPERIORITY_OR_OTHER||Slope|0.004|||<|0.001|TWO_SIDED||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.||||<0.001
71694977|NCT01022203|142904708|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Mixed Models Analysis|||General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.||||<0.0001
71694978|NCT04152200|142904746|OTHER|Not applied|Least Squares (LS) Mean|-33.33|STANDARD_ERROR_OF_MEAN|17.63|||TWO_SIDED|95.0|-81.82|15.16|||Mixed model repeated measures (MMRM)|||Restricted maximum likelihood (REML) based Mixed Model Repeated Measures (MMRM) was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||15.16|-81.82|
71694979|NCT04152200|142904747|OTHER|Not applied|Least Squares (LS) Mean|-42.43|STANDARD_ERROR_OF_MEAN|3.95|||TWO_SIDED|95.0|-50.71|-34.15|||MMRM|||REML based Mixed Model Repeated Measures MMRM was used to test against the null hypothesis of mean change from baseline outcome being equal to 0. The model includes scheduled visits and baseline plasma oxalate (μmol/L) as fixed effects and patient as a random factor. Autoregressive (1) was used to model the within-patient variability.||-34.15|-50.71|
71694980|NCT00593814|142904794|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Chi-squared|||||||<0.001
71694981|NCT00871624|142904810|NON_INFERIORITY_OR_EQUIVALENCE|A difference in the mean four-point NIV intolerance score of 1 over the course of the study or between groups was considered through investigator consensus to be clinically meaningful. Assuming that the SD of NIV intolerance scores was 1 and that an alpha of 0.05 would be used for testing, it was determined that 18 subjects were needed in each group to achieve an 80% power.|Odds Ratio (OR)|1.44||||0.54|TWO_SIDED|95.0|0.44|4.7|||Chi-squared|||||4.7|0.44|0.54
71694982|NCT00871624|142904811|OTHER|||||||0.3|||||||Chi-squared|||||||0.3
71942748|NCT01029353|143407191|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.44|1.36|||||RR: Initial Laparotomy over Peritoneal Drain. RR from robust Poisson regression with log link, reference cell coding, center as repeated measure. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||1.36|0.44|
71942749|NCT01029353|143407191|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.49, 1.33).|||
71942750|NCT01029353|143407192|SUPERIORITY||Mean Difference (Final Values)|-6.01|||||TWO_SIDED|95.0|-12.77|0.75|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||0.75|-12.77|
71942751|NCT01029353|143407192|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -2.68, 95% credible interval of (-7.11, 1.83).|||
71942752|NCT01029353|143407193|SUPERIORITY||Mean Difference (Final Values)|-8.75|||||TWO_SIDED|95.0|-17.05|-0.46|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||-0.46|-17.05|
71942753|NCT01029353|143407193|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -3.23, 95% credible interval of (-8.08, 1.68).|||
71942754|NCT01029353|143407194|SUPERIORITY||Mean Difference (Final Values)|6.59|||||TWO_SIDED|95.0|-9.09|22.27|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||22.27|-9.09|
71942755|NCT01029353|143407194|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was 1.65, 95% credible interval of (-3.97, 7.23).|||
71942756|NCT01029353|143407195|SUPERIORITY||Mean Difference (Final Values)|-2.56|||||TWO_SIDED|95.0|-13.02|7.91|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||7.91|-13.02|
71942757|NCT01029353|143407195|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -0.71, 95% credible interval of (-5.89, 4.48).|||
71694983|NCT00729521|142904844|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.92|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.95|||Mixed Models Analysis|Mixed Effects Poisson Regression|Comparison group is the control arm.|||0.95|0.88|<0.05
71694984|NCT00729521|142904844|SUPERIORITY_OR_OTHER||Incident Rate Ratio|0.91|STANDARD_DEVIATION|1.0|<|0.05|TWO_SIDED|95.0|0.88|0.94|||Mixed Models Analysis|Mixed Effected Poisson Model Regression|Comparison group is the control arm.|||0.94|0.88|<.05
71942758|NCT01029353|143407196|SUPERIORITY||Mean Difference (Final Values)|-13.95|||||TWO_SIDED|95.0|-30.54|2.63|||||Mean Difference (MD): Laparotomy minus Drain. MD from mixed model using PROC MIXED in SAS, center as random effect, and reference cell coding. Model included treatment, baseline risk of death or NDI, and pre-op diagnosis (NEC/IP) as covariates.|A frequentist analysis.||2.63|-30.54|
71942759|NCT01029353|143407196|SUPERIORITY|||||||||||||||||A Bayesian analysis. Initial Laparotomy and Initial Peritoneal Drain were compared using a hierarchical linear regression. The SAS procedure PROC MCMC with reference cell coding was used. Center (random effect), treatment, pre-operative diagnosis, and baseline risk of death or NDI were binary covariates. Pre-operative diagnosis levels were NEC and IP. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=1000), treatment, baseline risk, and preop diagnosis parameters = Normal(mean=0, variance=10), random effect standard deviation = Half-Normal(mean=0, variance=10). The posterior median difference Initial Laparotomy minus Initial Drainage was -1.78, 95% credible interval of (-7.44, 3.87).|||
71942760|NCT01029353|143407197|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.64|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.64|
71942761|NCT01029353|143407197|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.95|1.31|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.31|0.95|
71942762|NCT01029353|143407197|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.81, 95% credible interval of (0.63, 1.00). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.09, 95% credible interval of (0.90, 1.33).|||
71942763|NCT01029353|143407198|SUPERIORITY||Risk Ratio (RR)|0.77|||||TWO_SIDED|95.0|0.52|1.13|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.13|0.52|
71942764|NCT01029353|143407198|SUPERIORITY||Risk Ratio (RR)|1.28|||||TWO_SIDED|95.0|0.79|2.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.06|0.79|
71694985|NCT03652818|142904852|SUPERIORITY||Least Square (LS) Mean Difference|-25.2868|STANDARD_ERROR_OF_MEAN|16.1594|||ONE_SIDED|90.0||-4.421|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group B||-4.4210||
71942765|NCT01029353|143407198|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.82, 95% credible interval of (0.53, 1.20). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.18, 95% credible interval of (0.74, 1.87).|||
71942766|NCT01029353|143407199|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.42|1.27|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.27|0.42|
71942767|NCT01029353|143407199|SUPERIORITY||Risk Ratio (RR)|1.11|||||TWO_SIDED|95.0|0.85|1.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.45|0.85|
71942768|NCT01029353|143407199|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Pre-operative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.76, 95% credible interval of (0.48, 1.18). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.08, 95% credible interval of (0.83, 1.42).|||
71942769|NCT01029353|143407200|SUPERIORITY||Risk Ratio (RR)|0.7|||||TWO_SIDED|95.0|0.47|1.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.05|0.47|
71942770|NCT01029353|143407200|SUPERIORITY||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.76|1.19|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.19|0.76|
71942771|NCT01029353|143407200|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.73, 95% credible interval of (0.52, 0.96). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.95, 95% credible interval of (0.68, 1.32).|||
71942772|NCT01029353|143407201|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.61|1.06|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.06|0.61|
71694986|NCT03652818|142904852|SUPERIORITY||LS Mean Difference|-0.2756|STANDARD_ERROR_OF_MEAN|16.3283|||ONE_SIDED|90.0||20.8083|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group B||20.8083||
71694987|NCT03652818|142904852|SUPERIORITY||LS Mean Difference|-65.9241|STANDARD_ERROR_OF_MEAN|17.2146|||ONE_SIDED|90.0||-43.6959|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group C vs. Group A||-43.6959||
71942773|NCT01029353|143407201|SUPERIORITY||Risk Ratio (RR)|1.17|||||TWO_SIDED|95.0|1.01|1.37|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.37|1.01|
71942774|NCT01029353|143407201|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.80, 95% credible interval of (0.61, 1.01). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.15, 95% credible interval of (0.94, 1.42).|||
71942775|NCT01029353|143407202|SUPERIORITY||Risk Ratio (RR)|0.68|||||TWO_SIDED|95.0|0.46|1.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.01|0.46|
71942776|NCT01029353|143407202|SUPERIORITY||Risk Ratio (RR)|1.22|||||TWO_SIDED|95.0|0.74|2.01|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.01|0.74|
71942777|NCT01029353|143407202|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.72, 95% credible interval of (0.48, 1.05). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.12, 95% credible interval of (0.71, 1.76).|||
71942778|NCT01029353|143407203|SUPERIORITY||Risk Ratio (RR)|0.73|||||TWO_SIDED|95.0|0.51|1.04|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.04|0.51|
71694988|NCT03652818|142904852|SUPERIORITY||LS Mean Difference|-65.6486|STANDARD_ERROR_OF_MEAN|16.8753|||ONE_SIDED|90.0||-43.8584|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group B vs. Group A||-43.8584||
71694989|NCT03652818|142904852|SUPERIORITY||LS Mean Difference|-90.9353|STANDARD_ERROR_OF_MEAN|17.1044|||ONE_SIDED|90.0||-68.8494|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group A||-68.8494||
71694990|NCT03652818|142904852|SUPERIORITY||LS Mean Difference|-25.0112|STANDARD_ERROR_OF_MEAN|16.5376|||ONE_SIDED|90.0||-3.6571|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group D vs. Group C||-3.6571||
71694991|NCT03652818|142904852|SUPERIORITY||LS Mean Difference|10.9546|STANDARD_ERROR_OF_MEAN|21.0237|||ONE_SIDED|90.0||38.1014|||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The lower limit of one-sided 90% CI was -∞|Group E vs. Group D||38.1014||
71694992|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|33.6821|STANDARD_ERROR_OF_MEAN|20.1209|||ONE_SIDED|90.0|7.7011||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group B|||7.7011|
71694993|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|6.1658|STANDARD_ERROR_OF_MEAN|20.3312|||ONE_SIDED|90.0|-20.0868||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group B|||-20.0868|
71942779|NCT01029353|143407203|SUPERIORITY||Risk Ratio (RR)|1.25|||||TWO_SIDED|95.0|0.82|1.93|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.93|0.82|
71942780|NCT01029353|143407203|SUPERIORITY|||||||||||||||||A Bayesian analysis. Within pre-operative diagnosis, Initial Laparotomy and Initial Peritoneal Drain were compared using log-binomial regression. Pre-operative diagnosis levels were NEC and IP. PROC MCMC with effect coding was used. Center (random effect), treatment, pre-operative diagnosis, baseline risk, and the treatment by Preoperative diagnosis were the covariates. Markov chain Monte Carlo (MCMC) characteristics: three chains, 10000 tunings, 10000 burn-ins, 1000000 samples, thinning=20.|Priors for model parameters: intercept = Normal(mean=0, variance=100), baseline risk and preop diagnosis parameters = Normal(mean=0, variance=1), treatment and the interaction term = Normal(mean=0, variance=0.31416), random effect standard deviation = Half-Normal(mean=0, variance=10). For the NEC pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 0.77, 95% credible interval of (0.51, 1.14). For the IP pre-operative diagnosis, the posterior median relative risk of Initial Laparotomy over Initial Drainage was 1.17, 95% credible interval of (0.76, 1.81).|||
71942781|NCT01029353|143407204|SUPERIORITY||Risk Ratio (RR)|0.53|||||TWO_SIDED|95.0|0.31|0.89|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||0.89|0.31|
71942782|NCT01029353|143407204|SUPERIORITY||Risk Ratio (RR)|0.44|||||TWO_SIDED|95.0|0.29|0.66|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||0.66|0.29|
71942783|NCT01029353|143407205|SUPERIORITY||Risk Ratio (RR)|1.44|||||TWO_SIDED|95.0|0.58|3.57|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.57|0.58|
71942784|NCT01029353|143407205|SUPERIORITY||Risk Ratio (RR)|1.63|||||TWO_SIDED|95.0|1.06|2.5|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.50|1.06|
71942785|NCT01029353|143407206|SUPERIORITY||Risk Ratio (RR)|2.52|||||TWO_SIDED|95.0|0.84|7.55|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||7.55|0.84|
71942786|NCT01029353|143407206|SUPERIORITY||Risk Ratio (RR)|1.05|||||TWO_SIDED|95.0|0.38|2.88|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.88|0.38|
71942787|NCT01029353|143407207|SUPERIORITY||Risk Ratio (RR)|1.78|||||TWO_SIDED|95.0|0.82|3.86|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||3.86|0.82|
71694994|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|77.3395|STANDARD_ERROR_OF_MEAN|21.4347|||ONE_SIDED|90.0|49.662||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group C vs. Group A|||49.6620|
71694995|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|71.1737|STANDARD_ERROR_OF_MEAN|21.0123|||ONE_SIDED|90.0|44.0417||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group B vs. Group A|||44.0417|
71694996|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|104.8558|STANDARD_ERROR_OF_MEAN|21.2975|||ONE_SIDED|90.0|77.3555||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group A|||77.3555|
71694997|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|27.5163|STANDARD_ERROR_OF_MEAN|20.5918|||ONE_SIDED|90.0|0.9272||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group D vs. Group C|||0.9272|
71694998|NCT03652818|142904853|SUPERIORITY||LS Mean Difference|-30.1223|STANDARD_ERROR_OF_MEAN|26.1776|||ONE_SIDED|90.0|-63.924||||||Statistics are from ANCOVA including treatment and sex as fixed effects with baseline PI score prior to Dose 2 as a covariate. The upper limit was ∞|Group E vs. Group D|||-63.9240|
71694999|NCT01811732|142904877|NON_INFERIORITY|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|-2.6|||||TWO_SIDED|95.0|-8.8|3.6||||||||3.6|-8.8|
71695000|NCT01211145|142904908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.312|TWO_SIDED|95.0|0.75|2.5||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.50|0.75|.312
71695001|NCT01211145|142904908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.76||||0.071|TWO_SIDED|95.0|0.95|3.26||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.26|0.95|.071
71695002|NCT01211145|142904908|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.18|||<|0.001|TWO_SIDED|95.0|1.4|3.39||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||3.39|1.40|<.001
71695003|NCT01211145|142904909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.15||||0.575|TWO_SIDED|95.0|0.7|1.91||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.91|0.70|.575
71695004|NCT01211145|142904909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.032|TWO_SIDED|95.0|1.06|3.31||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.31|1.06|.032
71695005|NCT01211145|142904909|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.33||||0.137|TWO_SIDED|95.0|0.91|1.95||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||1.95|0.91|.137
71942788|NCT01029353|143407207|SUPERIORITY||Risk Ratio (RR)|1.16|||||TWO_SIDED|95.0|0.42|3.2|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||3.20|0.42|
71942789|NCT01029353|143407208|SUPERIORITY||Risk Ratio (RR)|1.68|||||TWO_SIDED|95.0|0.35|8.05|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||8.05|0.35|
71695006|NCT01211145|142904910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.2||||0.458|TWO_SIDED|95.0|0.74|1.96||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.96|0.74|.458
71695007|NCT01211145|142904910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.82||||0.021|TWO_SIDED|95.0|1.09|3.03||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||3.03|1.09|.021
71695008|NCT01211145|142904910|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.01|TWO_SIDED|95.0|1.12|2.32||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.32|1.12|.010
71695009|NCT01211145|142904911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.09||||0.753|TWO_SIDED|95.0|0.64|1.84||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.84|0.64|.753
71695010|NCT01211145|142904911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.55||||0.145|TWO_SIDED|95.0|0.86|2.79||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.79|0.86|.145
71695011|NCT01211145|142904911|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.37||||0.127|TWO_SIDED|95.0|0.91|2.04||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.04|0.91|.127
71695012|NCT01211145|142904912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.35||||0.274|TWO_SIDED|95.0|0.79|2.32||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||2.32|0.79|.274
71695013|NCT01211145|142904912|SUPERIORITY_OR_OTHER||Odds Ratio, log|1.67||||0.067|TWO_SIDED|95.0|0.96|2.91||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||2.91|0.96|.067
71695014|NCT01211145|142904912|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.38||||0.127|TWO_SIDED|95.0|0.91|2.08||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||2.08|0.91|.127
71695015|NCT01211145|142904913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.67||||0.153|TWO_SIDED|95.0|0.38|1.16||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo|||1.16|0.38|.153
71695016|NCT01211145|142904913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.59||||0.087|TWO_SIDED|95.0|0.33|1.08||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo|||1.08|0.33|.087
71695017|NCT01211145|142904913|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.54||||0.004|TWO_SIDED|95.0|0.36|0.83||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo|||0.83|0.36|.004
71695018|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-14.5|||<|0.001|TWO_SIDED|95.0|-18.0|-11.0|||ANCOVA|||Bima 30mg/kg + Sema 2.4mg vs Placebo||-11.0|-18.0|<0.001
71695019|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-10.5|||<|0.001|TWO_SIDED|95.0|-14.0|-7.09|||ANCOVA|||Bima 30mg/kg + Sema 1.0mg vs Placebo||-7.09|-14.0|<0.001
71695020|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-11.0|||<|0.001|TWO_SIDED|95.0|-14.4|-7.55|||ANCOVA|||Bima 10mg/kg + Sema 2.4mg vs Placebo||-7.55|-14.4|<0.001
71695021|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-9.41|||<|0.001|TWO_SIDED|95.0|-12.9|-5.93|||ANCOVA|||Bima 10mg/kg + Sema 1.0mg vs Placebo||-5.93|-12.9|<.001
71695022|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-10.9|||<|0.001|TWO_SIDED|95.0|-14.4|-7.46|||ANCOVA|||Sema 2.4mg vs Placebo||-7.46|-14.4|<0.001
71695023|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-6.45|||<|0.001|TWO_SIDED|95.0|-9.96|-2.94|||ANCOVA|||Sema 1.0mg vs Placebo||-2.94|-9.96|<0.001
71695024|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-5.94|||<|0.001|TWO_SIDED|95.0|-9.47|-2.41|||ANCOVA|||Bima 30mg/kg vs Placebo||-2.41|-9.47|<0.001
71695025|NCT05616013|142904932|SUPERIORITY||LS Mean Change difference|-2.68||||0.133|TWO_SIDED|95.0|-6.18|0.82|||ANCOVA|||Bima 10mg/kg vs Placebo||0.82|-6.18|0.133
71695026|NCT05116202|142904973|SUPERIORITY||Difference in pRR|2.73|||||TWO_SIDED|95.0|-22.25|27.7||||||||27.70|-22.25|
71695027|NCT05116202|142904973|SUPERIORITY||Difference in pRR|-32.27|||||TWO_SIDED|95.0|-65.01|0.46||||||||0.46|-65.01|
71695028|NCT05116202|142904973|SUPERIORITY||Difference in pRR|-17.27|||||TWO_SIDED|95.0|-49.75|15.21||||||||15.21|-49.75|
71695029|NCT05116202|142904975|SUPERIORITY||Difference in pRR|-6.82|||||TWO_SIDED|95.0|-31.31|17.68||||||||17.68|-31.31|
71695030|NCT05116202|142904975|SUPERIORITY||Difference in pRR|-31.82|||||TWO_SIDED|95.0|-63.79|0.16||||||||0.16|-63.79|
71695031|NCT05116202|142904975|SUPERIORITY||Difference in pRR|-21.82|||||TWO_SIDED|95.0|-53.44|9.8||||||||9.80|-53.44|
71942790|NCT01029353|143407208|SUPERIORITY||Risk Ratio (RR)|0.5|||||TWO_SIDED|95.0|0.1|2.44|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||2.44|0.10|
71942791|NCT01029353|143407209|SUPERIORITY||Risk Ratio (RR)|1.29|||||TWO_SIDED|95.0|0.62|2.69|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||2.69|0.62|
71695032|NCT05116202|142904976|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.42|10.42||||||||10.42|0.42|
71695033|NCT05116202|142904976|SUPERIORITY||Hazard Ratio (HR)|3.95|||||TWO_SIDED|95.0|0.79|19.7||||||||19.70|0.79|
71695034|NCT05116202|142904976|SUPERIORITY||Hazard Ratio (HR)|6.27|||||TWO_SIDED|95.0|0.73|53.7||||||||53.70|0.73|
71695035|NCT05116202|142904977|SUPERIORITY||Hazard Ratio (HR)|1.41|||||TWO_SIDED|95.0|0.25|7.75||||||||7.75|0.25|
71695036|NCT05116202|142904977|SUPERIORITY||Hazard Ratio (HR)|2.09|||||TWO_SIDED|95.0|0.35|12.62||||||||12.62|0.35|
71695037|NCT05116202|142904977|SUPERIORITY||Hazard Ratio (HR)|2.39|||||TWO_SIDED|95.0|0.22|26.32||||||||26.32|0.22|
71695038|NCT05116202|142904978|SUPERIORITY||Hazard Ratio (HR)|0.78|||||TWO_SIDED|95.0|0.05|12.39||||||||12.39|0.05|
71695039|NCT05116202|142904978|SUPERIORITY||Hazard Ratio (HR)|2.59|||||TWO_SIDED|95.0|0.23|28.65||||||||28.65|0.23|
71695040|NCT05116202|142904978|SUPERIORITY||Hazard Ratio (HR)|1.16|||||TWO_SIDED|95.0|0.07|18.58||||||||18.58|0.07|
71695041|NCT05116202|142904979|SUPERIORITY||Difference in ORR|-21.59|||||TWO_SIDED|95.0|-50.55|7.37||||||||7.37|-50.55|
71695042|NCT05116202|142904979|SUPERIORITY||Difference in ORR|-24.09|||||TWO_SIDED|95.0|-58.17|9.99||||||||9.99|-58.17|
71695043|NCT05116202|142904979|SUPERIORITY||Difference in ORR|0.91|||||TWO_SIDED|95.0|-33.58|35.4||||||||35.40|-33.58|
71695044|NCT02668640|142905023|OTHER||||||=|0.0002|||||||Wilcoxon signed-rank test|||||||=0.0002
71695045|NCT02668640|142905024|OTHER||||||=|0.0006|||||||Wilcoxon signed-rank test|||||||=0.0006
71695046|NCT02668640|142905025|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 12||||<0.0001
71695047|NCT02668640|142905025|OTHER||||||=|0.1233|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 12||||=0.1233
71695048|NCT02668640|142905025|OTHER||||||<|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 24||||<0.001
71695049|NCT02668640|142905025|OTHER||||||=|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 24||||=0.001
71695050|NCT02668640|142905026|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 12||||<0.0001
71695051|NCT02668640|142905026|OTHER||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 24||||<0.0001
71695052|NCT02668640|142905027|OTHER||||||=|0.0137|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12||||=0.0137
71695053|NCT02668640|142905027|OTHER||||||=|0.0607|||||||Wilcoxon signed-rank test|||Median Change from Baseline in Overall Work Impairment Score at Week 24||||=0.0607
71695054|NCT02668640|142905028|OTHER||||||=|0.0026|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 12||||=0.0026
71695055|NCT02668640|142905028|OTHER||||||=|0.0001|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 24||||=0.0001
71695056|NCT03669588|142905031|SUPERIORITY||Odds Ratio (OR)|4.951|||<|0.0001|TWO_SIDED|95.0|2.213|11.528|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese versus (vs) non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||11.528|2.213|<0.0001
71695057|NCT03669588|142905032|SUPERIORITY||Odds Ratio (OR)|10.842|||<|0.0001|TWO_SIDED|95.0|4.179|31.2|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the AChR-Ab seropositive population, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline QMG total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||31.200|4.179|<0.0001
71695058|NCT03669588|142905033|SUPERIORITY||Odds Ratio (OR)|3.699|||<|0.0001|TWO_SIDED|95.0|1.854|7.578|||Regression, Logistic|||"Analysis with a 2-sided exact test (using logistic regression) at the 2-sided 5% significance level in the overall population, stratified by AChR-Ab status (seropositive vs seronegative), Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment, with cycle baseline MG-ADL total score as covariate.~The treatment effect was presented as the odds ratio. An odds ratio of more than 1 represents a higher response rate for ARGX-113 compared to placebo."||7.578|1.854|<0.0001
71695059|NCT03669588|142905034|SUPERIORITY||Least square means difference|22.065|STANDARD_ERROR_OF_MEAN|5.616||0.0001|TWO_SIDED|95.0|10.949|33.181|||ANCOVA|||Analysis of covariance (ANCOVA) in the AChR-Ab seropositive population with treatment, baseline MG-ADL total score, Japanese vs non-Japanese, and NSID vs no NSID as concomitant gMG treatment as the covariates.||33.181|10.949|0.0001
71942792|NCT01029353|143407209|SUPERIORITY||Risk Ratio (RR)|0.6|||||TWO_SIDED|95.0|0.27|1.32|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.32|0.27|
71695060|NCT03669588|142905035|SUPERIORITY|||||||0.2604|||||||Log Rank|||Analysis was performed in the AChR-Ab seropositive population and the p-value was calculated using the log-rank test, stratified by Japanese vs non-Japanese and NSID vs no NSID as concomitant gMG treatment.||||0.2604
71695061|NCT01721447|142905037|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
71695062|NCT01721447|142905038|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||< 0.001
71695063|NCT00369343|142905039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.32|||<|0.001||95.0|2.53|6.11|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.|DVS SR adjusted mean change minus placebo adjusted mean change.|||6.11|2.53|<0.001
71695064|NCT00369343|142905040|SUPERIORITY_OR_OTHER||||||<|0.001||||||DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).|Cochran-Mantel-Haenszel|||||||<0.001
71695065|NCT00369343|142905041|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.132||||0.008||95.0|1.22|3.74||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.|||3.74|1.22|0.008
71942793|NCT01029353|143407210|SUPERIORITY||Risk Ratio (RR)|0.75|||||TWO_SIDED|95.0|0.41|1.36|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||1.36|0.41|
71695066|NCT00369343|142905042|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.125|||<|0.001||95.0|1.85|5.27||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.|||5.27|1.85|<0.001
71695067|NCT00369343|142905043|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.74|||<|0.001||95.0|1.24|4.23||Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||4.23|1.24|<0.001
71695068|NCT00369343|142905044|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.18|-0.06||Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.|||-0.06|-0.18|<0.001
71695069|NCT00369343|142905051|SUPERIORITY_OR_OTHER|||||||0.553||||||t-test adjusted by multiple comparison|t-test, 2 sided|||100mg vs. Placebo (0mg) post taper||||0.553
71695070|NCT00369343|142905051|SUPERIORITY_OR_OTHER|||||||0.034||||||t-test adjusted by multiple comparison|t-test, 2 sided|||200mg vs. Placebo (0mg) post taper||||0.034
71695071|NCT01100502|142905052|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.57||||0.001|TWO_SIDED|95.0|0.4|0.81|||Log Rank|||||0.81|0.40|0.001
71695072|NCT02322749|142905056|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric Least Squares (LS) Mean Ratio|9.32|||||TWO_SIDED|90.0|8.25|10.53|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||10.53|8.25|
71942794|NCT01029353|143407210|SUPERIORITY||Risk Ratio (RR)|0.99|||||TWO_SIDED|95.0|0.69|1.42|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.42|0.69|
71942795|NCT01029353|143407211|SUPERIORITY||Risk Ratio (RR)|0.43|||||TWO_SIDED|95.0|0.04|4.45|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to NEC.||4.45|0.04|
71942796|NCT01029353|143407211|SUPERIORITY||Risk Ratio (RR)|0.81|||||TWO_SIDED|95.0|0.44|1.49|||||The model was fit using PROC GENMOD in SAS, using center as the repeated effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a robust Poisson regression model, with log link and center as repeated measure. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy over drain) when pre-operative diagnosis is equal to IP.||1.49|0.44|
71942797|NCT01029353|143407212|SUPERIORITY||Mean Difference (Final Values)|-1.27|||||TWO_SIDED|95.0|-14.1|11.6|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.60|-14.10|
71942798|NCT01029353|143407212|SUPERIORITY||Mean Difference (Final Values)|-7.85|||||TWO_SIDED|95.0|-15.84|0.13|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||0.13|-15.84|
71942799|NCT01029353|143407213|SUPERIORITY||Mean Difference (Final Values)|-11.57|||||TWO_SIDED|95.0|-27.15|4.01|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||4.01|-27.15|
71942800|NCT01029353|143407213|SUPERIORITY||Mean Difference (Final Values)|-7.63|||||TWO_SIDED|95.0|-17.46|2.2|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||2.20|-17.46|
71942801|NCT01029353|143407214|SUPERIORITY||Mean Difference (Final Values)|4.0|||||TWO_SIDED|95.0|-18.84|26.83|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||26.83|-18.84|
71942802|NCT01029353|143407214|SUPERIORITY||Mean Difference (Final Values)|9.05|||||TWO_SIDED|95.0|-13.29|31.38|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||31.38|-13.29|
71942803|NCT01029353|143407215|SUPERIORITY||Mean Difference (Final Values)|-3.13|||||TWO_SIDED|95.0|-24.62|18.36|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||18.36|-24.62|
71942804|NCT01029353|143407215|SUPERIORITY||Mean Difference (Final Values)|-2.39|||||TWO_SIDED|95.0|-14.42|9.63|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates. Reported results in this analysis restricted to infants with IP.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||9.63|-14.42|
71942805|NCT01029353|143407216|SUPERIORITY||Mean Difference (Final Values)|-18.43|||||TWO_SIDED|95.0|-48.41|11.55|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to NEC.||11.55|-48.41|
71942806|NCT01029353|143407216|SUPERIORITY||Mean Difference (Final Values)|-11.95|||||TWO_SIDED|95.0|-31.96|8.06|||||The model was fit using PROC MIXED in SAS, using center as the random effect. Effect coding was used to represent the binary covariates.|This by treatment and by pre-operative diagnosis secondary analysis was completed by using a mixed linear regression model, using center as the random effect. Model included treatment, baseline risk of death or NDI, pre-op diagnosis (NEC/IP), and treatment by pre-op diagnosis as covariates. Reported results in this analysis restricted to model based treatment effect estimate (laparotomy minus drain) when pre-operative diagnosis is equal to IP.||8.06|-31.96|
71942807|NCT03603314|143407222|SUPERIORITY|||||||0.3419|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3419
71942808|NCT03603314|143407222|SUPERIORITY|||||||0.5181|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5181
71942809|NCT03603314|143407223|SUPERIORITY|||||||0.3666|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3666
71942810|NCT03603314|143407223|SUPERIORITY|||||||0.5776|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.5776
71942811|NCT03603314|143407224|SUPERIORITY|||||||0.4094|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4094
71942812|NCT03603314|143407224|SUPERIORITY|||||||0.4602|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4602
71942813|NCT03603314|143407225|SUPERIORITY|||||||0.1269|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1269
71942814|NCT03603314|143407225|SUPERIORITY|||||||0.2257|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.2257
71942815|NCT03603314|143407226|SUPERIORITY|||||||0.3121|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.3121
71942816|NCT03603314|143407226|SUPERIORITY|||||||0.4965|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.4965
71695073|NCT02322749|142905057|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS Mean Ratio|24.26|||||TWO_SIDED|90.0|22.62|26.03|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||26.03|22.62|
71695074|NCT02322749|142905058|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS mean ratio|22.12|||||TWO_SIDED|90.0|20.65|23.69|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||23.69|20.65|
71695075|NCT02322749|142905059|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.93|||||TWO_SIDED|90.0|11.42|14.65|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.65|11.42|
71695076|NCT02322749|142905060|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|26.2|||||TWO_SIDED|90.0|24.44|28.09|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||28.09|24.44|
71695077|NCT02322749|142905061|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|23.6|||||TWO_SIDED|90.0|22.02|25.3|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||25.30|22.02|
71695078|NCT02322749|142905062|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|9.66|||||TWO_SIDED|90.0|8.5|10.97|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect|||10.97|8.5|
71695079|NCT02322749|142905062|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|13.04|||||TWO_SIDED|90.0|11.45|14.86|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.86|11.45|
71695080|NCT02322749|142905063|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|11.31|||||TWO_SIDED|90.0|9.8|13.05|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||13.05|9.80|
71695081|NCT02322749|142905063|SUPERIORITY_OR_OTHER||Geometric LS Mean Ratio|12.8|||||TWO_SIDED|90.0|11.07|14.8|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.|||14.80|11.07|
71695082|NCT01190813|142905073|SUPERIORITY_OR_OTHER||Percent Difference|11.0||||0.06|TWO_SIDED|95.0|-7.0|28.0|||Fisher Exact|It was not possible to adjust for baseline VA in these secondary analyses due to the small number of subjects meeting secondary outcome criteria.|Treatment group difference calculated as Levodopa - Placebo|A sample size of 129 participants provided 80% power with 1-sided type I error rate of 5% to reject the hypothesis of no difference between groups if the proportion improved was 30% in the levodopa group compared with 10% in the placebo group.||28|-7|0.06
71942817|NCT03603314|143407227|SUPERIORITY|||||||0.0976|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.0976
71942818|NCT03603314|143407227|SUPERIORITY|||||||0.1762|||||||Mixed Models Analysis|||The null and alternative hypotheses for Part 1 of the study were as follows, where μH, μL and μP were defined as the mean change in PTA of the high dose, low dose, and placebo respectively: H0H: μH - μP = 0, HAH: μH - μP \<0 (greater decrease on high dose) H0L: μL - μP = 0, HAL: μL - μP \<0 (greater decrease on low dose)||||0.1762
71942819|NCT00819507|143407234|SUPERIORITY||Mean Difference (Final Values)|6.01|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71942820|NCT00819507|143407235|SUPERIORITY||Median Difference (Final Values)|14.35|||<|0.01|TWO_SIDED||||||t-test, 2 sided|||||||<0.01
71942821|NCT00565448|143407259|SUPERIORITY_OR_OTHER|||||||1|TWO_SIDED|95.0||||The Fisher's exact test was used to compare the CR proportions.|Fisher Exact|||There was no formal power calculation. A selection design was used to determine how many participants would be accrued to correctly select the treatment group with the best CR rate with 80% probability.||||1.0000
71695083|NCT01190813|142905076|SUPERIORITY_OR_OTHER||Percent Difference|0.0|||||TWO_SIDED|95.0|-17.0|18.0|||||Levodopa - Placebo|||18|-17|
71695084|NCT01190813|142905077|SUPERIORITY_OR_OTHER||Percent Difference|-7.0|||||TWO_SIDED|95.0|-25.0|10.0||||||||10|-25|
71695085|NCT01190813|142905078|SUPERIORITY_OR_OTHER||Percent Difference|-5.0|||||TWO_SIDED|95.0|-22.0|13.0|||||Levodopa - Placebo|||13|-22|
71695086|NCT01190813|142905086|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.65|TWO_SIDED|95.0|-1.9|1.3|||ANCOVA||Mean difference calculated as Levodopa - Placebo|||1.3|-1.9|0.65
71695087|NCT01190813|142905088|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.44|TWO_SIDED|95.0|-1.6|1.8|||ANCOVA|||||1.8|-1.6|0.44
71695088|NCT01190813|142905090|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.2|TWO_SIDED|95.0|-1.2|2.9|||ANCOVA|||||2.9|-1.2|0.20
71695089|NCT01190813|142905092|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.9||||0.17|TWO_SIDED||||||ANCOVA|||||||0.17
71695090|NCT01190813|142905096|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.4||||0.06|TWO_SIDED|95.0|-0.4|3.3||The alpha level was set to 0.0485 for the primary analysis to adjust for alpha spending of 0.015 for one interim analysis for efficacy conducted when outcome data were available for 50% of participants.|ANCOVA||Mean difference calculated as Levodopa - Placebo|With 129 participants, assuming a 1-sided type I error rate of 4.85%, there was 96% power to detect a difference in mean visual acuity between treatment groups at 18 weeks adjusted for baseline and for 1 interim analysis for futility if the true difference was 5 letters with SD of 7 letters and 82% power if the true difference was 3.75 letters||3.3|-0.4|0.06
71695091|NCT04414787|142905143|SUPERIORITY||Mean Difference (Final Values)|0.0||||1|TWO_SIDED|95.0|-6.21|6.21|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (\~1 week post-randomization)||6.21|-6.21|1.00
71942822|NCT00302952|143407263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.79||||||Adjustments were made for baseline ln(CRP), baseline DAS28-CRP score, race, methotrexate use, anti-TNF use, and disease duration.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group. Log transformed CRP was analyzed to meet the heterogeneity assumption for ANCOVA models.||||0.79
71942823|NCT00302952|143407265|SUPERIORITY_OR_OTHER_LEGACY|||||||0.91||||||Adjustments were made for baseline DAS28-CRP score.|ANCOVA|ANOVA was performed on participants with a DAS28-CRP score at Day 84.||The p-value compares Lovastatin with the Placebo treatment group.||||0.91
71942824|NCT00302952|143407266|SUPERIORITY_OR_OTHER_LEGACY||Difference in Percentage|-11.0||||0.39|TWO_SIDED|95.0|-35.9|14.0|||Chi-squared||The difference in percentages is calculated as Lovastatin - Placebo.|The p-value compares Lovastatin with the Placebo treatment group.||14.0|-35.9|0.39
71942825|NCT00302952|143407267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.19||||||Adjustments were made for baseline serum IgM RF by ELISA test result. In the ANCOVA model, baseline value was a covariate; therefore, an adjustment was performed.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.19
71942826|NCT00302952|143407268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Adjustments were made for baseline serum anti-CCP by ELISA|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.||||0.35
71942827|NCT02597101|143407278|OTHER|REML mixed model|REML mixed model|0.05|||<|0.05|TWO_SIDED|||||Using REML mixed model analysis, differences between study arms resulting in a p\<0.05 would represent statistically-significant differences.|REML mixed model|||The primary efficacy endpoint is the improvement of insulin sensitivity by 40% or greater at 6 months compared to baseline, assessed by the hyperinsulinemic-euglycemic clamp method.||||<0.05
71942828|NCT02373098|143407287|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CCL5=RANTES||||0.000
71942829|NCT02373098|143407287|OTHER|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||IL17A||||0.035
71942830|NCT02373098|143407287|OTHER|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||CXCL13||||0.911
71942831|NCT02373098|143407287|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||IL6||||1.000
71942832|NCT02373098|143407287|OTHER|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||IL8||||0.934
71942833|NCT02373098|143407287|OTHER|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||IL13||||0.727
71942834|NCT02373098|143407287|OTHER|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||IL23||||0.179
71942835|NCT02373098|143407287|OTHER|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||VLA4||||0.208
71942836|NCT02373098|143407287|OTHER|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||CXCL10=IP-10 (CXCR3 ligand)||||0.730
71942837|NCT02373098|143407287|OTHER|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||CCL2=MCP-1||||0.725
71942838|NCT02373098|143407287|OTHER|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||IL4||||0.057
71942839|NCT02373098|143407287|OTHER|||||||0.724|||||||Wilcoxon (Mann-Whitney)|||TNF alpha||||0.724
71942840|NCT02373098|143407287|OTHER|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||IL22||||0.662
71942841|NCT02373098|143407288|OTHER|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||CD3 abs||||0.256
71942842|NCT02373098|143407288|OTHER|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||CD19 abs||||0.587
71942843|NCT02373098|143407288|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||NK abs||||0.300
71942844|NCT02373098|143407288|OTHER|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||NKT abs||||0.096
71942845|NCT02373098|143407288|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 abs||||0.270
71942846|NCT02373098|143407288|OTHER|||||||0.902|||||||Wilcoxon (Mann-Whitney)|||CD4CD25||||0.902
71942847|NCT02373098|143407288|OTHER|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||Hi CD4CD25||||0.283
71942848|NCT02373098|143407291|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD3 %||||0.017
71942849|NCT02373098|143407291|OTHER|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||CD19 %||||0.300
71942850|NCT02373098|143407291|OTHER|||||||0.657|||||||Wilcoxon (Mann-Whitney)|||NK %||||0.657
71942851|NCT02373098|143407291|OTHER|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||NKT %||||0.439
71942852|NCT02373098|143407291|OTHER|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 %||||0.449
71942853|NCT02373098|143407291|OTHER|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.356
71942854|NCT02373098|143407291|OTHER|||||||0.787|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.787
71942855|NCT02373098|143407291|OTHER|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||CD3CD4||||0.121
71942856|NCT02373098|143407291|OTHER|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||CD3CD8||||0.209
71942857|NCT02373098|143407291|OTHER|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||CD4+IFNg+ (in CD4+)||||0.069
71942858|NCT02373098|143407291|OTHER|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||CD4+IL17+ (in CD4+)||||0.402
71942859|NCT02373098|143407291|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IFNg+ (in CD8+)||||0.017
71942860|NCT02373098|143407291|OTHER|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IL17+ (in CD8+)||||0.017
71942861|NCT02373098|143407291|OTHER|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||IFNg+ (in CD4+CD25+)||||0.026
71942862|NCT02373098|143407291|OTHER|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||IL17+ (in CD4+CD25+)||||0.168
71942863|NCT02373098|143407291|OTHER|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||CD4+IL10+ (in CD4+)||||0.004
71942864|NCT02373098|143407291|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD4+IL4+ (in CD4+)||||0.013
71942865|NCT02373098|143407291|OTHER|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||CD4-CD8-IL4+ (in CD4-CD8-)||||0.171
71942866|NCT02373098|143407291|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL10+ (in CD8+)||||0.013
71942867|NCT02373098|143407291|OTHER|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL4+ (in CD8+)||||0.013
71942868|NCT02373098|143407291|OTHER|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||IL10+ (in CD4+CD25+)||||0.007
71942869|NCT02373098|143407291|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||IL4+ (in CD4+CD25+)||||0.001
71942870|NCT02373098|143407291|OTHER|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||CD4+TNFa+ (in CD4+)||||0.002
71942871|NCT02373098|143407291|OTHER|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||CD4+IL9+ (in CD4+)||||0.107
71942872|NCT02373098|143407291|OTHER|||||||0|||||||Wilcoxon (Mann-Whitney)|||CD8+TNFa+ (in CD8+)||||0.000
71942873|NCT02373098|143407291|OTHER|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||CD8+IL9+ (in CD8+)||||0.022
71942874|NCT02373098|143407291|OTHER|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||TNFa+ (in CD4+CD25+)||||0.001
71942875|NCT02373098|143407291|OTHER|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||IL9+ (in CD4+CD25+)||||0.127
71942876|NCT00420238|143407294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.83||||0.019|TWO_SIDED|95.0|-16.5|-1.51|||ANCOVA||Least squares mean difference = mean difference final value.|Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.||-1.51|-16.5|0.019
71942877|NCT00420238|143407295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.92||||0.098|TWO_SIDED|95.0|0.82|10.42|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||10.42|0.82|0.098
71942878|NCT00420238|143407295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.02||||0.197|TWO_SIDED|95.0|0.69|5.88|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.88|0.69|0.197
71942879|NCT00420238|143407295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.89|5.95|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||5.95|0.89|0.087
71942880|NCT00420238|143407295|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.83||||0.031|TWO_SIDED|95.0|1.1|7.29|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.||7.29|1.10|0.031
71942881|NCT00420238|143407296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.68||||0.31|TWO_SIDED|95.0|0.62|4.57|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.57|0.62|0.310
71695092|NCT04414787|142905144|SUPERIORITY||Mean Difference (Final Values)|-0.06||||0.95|TWO_SIDED|95.0|-1.83|1.72|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.72|-1.83|0.95
71695093|NCT04414787|142905145|SUPERIORITY||Mean Difference (Final Values)|0.29||||0.72|TWO_SIDED|95.0|-1.28|1.86|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||1.86|-1.28|0.72
71695094|NCT04414787|142905146|SUPERIORITY||Mean Difference (Final Values)|1.35||||0.48|TWO_SIDED|95.0|-2.44|5.14|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 4 (3 months post-randomization)||5.14|-2.44|0.48
71695095|NCT04414787|142905147|SUPERIORITY||Odds Ratio (OR)|0.49||||0.12|TWO_SIDED|95.0|0.2|1.2|||Mixed Models Analysis|||Difference between Time 1 (baseline) and Time 3 (target \~1 week post-randomization)||1.2|0.20|0.12
71695096|NCT04414787|142905148|SUPERIORITY|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||||||0.58
71695097|NCT04414787|142905149|SUPERIORITY|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||||||0.29
71695098|NCT04414787|142905150|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71942882|NCT00420238|143407296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61||||0.309|TWO_SIDED|95.0|0.65|3.99|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||3.99|0.65|0.309
71942883|NCT00420238|143407296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.61||||0.001|TWO_SIDED|95.0|1.81|11.74|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.74|1.81|0.001
71942884|NCT00420238|143407296|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.14||||0.003||95.0|1.65|10.42|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||10.42|1.65|0.003
71695099|NCT01121263|142905164|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.063||||0.8||95.0|0.666|1.697|||Regression, Cox|The Cox proportional hazards regression model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|The Cox model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|This applies to any MACCE||1.697|0.666|0.80
71695100|NCT01121263|142905165|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.53||95.0|0.556|1.355|||Regression, Cox||The Cox proportional hazards regression model was weighted by the propensity score to account for the difference in baseline risk between groups.|This applies to any MACCE||1.355|0.556|0.53
71695101|NCT03246347|142905216|SUPERIORITY||Proportion|0.6111|||<|0.001|TWO_SIDED|95.0|0.4346|0.7686|||One-sided test for binomial proportions|||The 12-month PSA CR rate with ADT + docetaxel is 27.7% (Sweeney 2015); we estimated that the lower limit of the 95% CI was 23.4%. We sought to test the null hypothesis that the 52-week PSA CR rate for subjects treated with study therapy was \<=25%. We anticipated enrolling 39 subjects and this design would provide 90% power with a 1-sided alpha =0.10 significance level, assuming the true 52-week PSA CR rate was 45%. An improvement from 25% to 45% in 52-week PSA CR rate was considered important.||.7686|.4346|<0.001
71695102|NCT03205150|142905255|SUPERIORITY||Mean Difference (Net)|-13.29|STANDARD_ERROR_OF_MEAN|7.35||0.075|TWO_SIDED|80.0|-22.8|-3.78|||ANCOVA|||||-3.78|-22.80|0.075
71695103|NCT03205150|142905255|SUPERIORITY||Mean Difference (Net)|-21.64|STANDARD_ERROR_OF_MEAN|7.49||0.005|TWO_SIDED|80.0|-31.33|-11.94|||ANCOVA|||||-11.94|-31.33|0.005
71695104|NCT03205150|142905255|SUPERIORITY||Mean Difference (Net)|8.35|STANDARD_ERROR_OF_MEAN|6.14||0.178|TWO_SIDED|80.0|0.41|16.29|||ANCOVA|||||16.29|0.41|0.178
71695105|NCT03205150|142905256|SUPERIORITY||Mean Difference (Net)|-1.73|STANDARD_ERROR_OF_MEAN|1.45||0.235|TWO_SIDED|80.0|-3.6|0.14|||ANCOVA|||||0.14|-3.60|0.235
71695106|NCT03205150|142905256|SUPERIORITY||Mean Difference (Net)|-4.26|STANDARD_ERROR_OF_MEAN|1.46||0.004|TWO_SIDED|80.0|-6.14|-2.37|||ANCOVA|||||-2.37|-6.14|0.004
71695107|NCT03205150|142905256|SUPERIORITY||Mean Difference (Net)|2.52|STANDARD_ERROR_OF_MEAN|1.19||0.037|TWO_SIDED|80.0|0.98|4.07|||ANCOVA|||||4.07|0.98|0.037
71695108|NCT03205150|142905257|SUPERIORITY||Mean Difference (Net)|-3.15|STANDARD_ERROR_OF_MEAN|0.83|<|0.001|TWO_SIDED|80.0|-4.22|-2.08|||ANCOVA|||||-2.08|-4.22|<.001
71695109|NCT03205150|142905257|SUPERIORITY||Mean Difference (Net)|-4.18|STANDARD_ERROR_OF_MEAN|0.85|<|0.001|TWO_SIDED|80.0|-5.28|-3.08|||ANCOVA|||||-3.08|-5.28|<.001
71695110|NCT03205150|142905257|SUPERIORITY||Mean Difference (Net)|1.03|STANDARD_ERROR_OF_MEAN|0.71||0.148|TWO_SIDED|80.0|0.12|1.94|||ANCOVA|||||1.94|0.12|0.148
71695111|NCT03205150|142905265|SUPERIORITY||Mean Difference (Net)|-11.15|STANDARD_ERROR_OF_MEAN|4.36||0.013|TWO_SIDED|80.0|-16.79|-5.5|||ANCOVA|||||-5.50|-16.79|0.013
71695112|NCT03205150|142905265|SUPERIORITY||Mean Difference (Net)|-14.71|STANDARD_ERROR_OF_MEAN|4.43||0.001|TWO_SIDED|80.0|-20.43|-8.98|||ANCOVA|||||-8.98|-20.43|0.001
71695113|NCT03205150|142905265|SUPERIORITY||Mean Difference (Net)|3.56|STANDARD_ERROR_OF_MEAN|3.65||0.332|TWO_SIDED|80.0|-1.15|8.28|||ANCOVA|||||8.28|-1.15|0.332
71695114|NCT00789321|142905275|SUPERIORITY_OR_OTHER||Least Squares Mean|-11.7||||0.001||90.0|-18.1|-5.4|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||-5.4|-18.1|0.001
71695115|NCT00789321|142905276|SUPERIORITY_OR_OTHER||Least Squares Mean|39.0||||0.001||95.0|17.9|60.1|||ANCOVA|Change from baseline in systolic blood pressure included as covariate||||60.1|17.9|0.001
71695116|NCT03964207|142905279|SUPERIORITY||Difference of LSmeans|-5.28||||0.007|TWO_SIDED|95.0|-9.07|-1.48|||Mixed-effects Model||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||-1.48|-9.07|0.007
71695117|NCT03964207|142905280|SUPERIORITY||Difference of LSmeans|-4.14||||0.024|TWO_SIDED|95.0|-7.72|-0.56|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect||-0.56|-7.72|0.024
71695118|NCT03964207|142905281|SUPERIORITY||Difference rate (%)|13.0||||0.249|||||||Chi-square test||The Difference rate was calculated as: value from the test treatment group - value from the comparator treatment group.|Chi-squared test was used to analyze proportion of patients indicating preference in the Patient satisfaction and preference questionnaire (PASAPQ) at week 8. All participants have used both treatments at this point: Handihaler (4 weeks) and Respimat (4 weeks).||||0.249
71695119|NCT03964207|142905282|SUPERIORITY||Difference of LSmeans|-4.72||||0.057|TWO_SIDED|95.0|-9.59|0.15|||The mixed model for repeated measures||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||0.15|-9.59|0.057
71695120|NCT03964207|142905283|SUPERIORITY||Difference of LSmeans|-4.38||||0.347|TWO_SIDED|95.0|-13.63|4.86|||Mixed Models Analysis||The Least squares means (LSmeans) were adjusted with treatment and visit. And the Difference of LSmeans was calculated as: value from the test treatment group - value from the comparator treatment group.|The hypothesis test was held to investigate the superiority of the test treatment. Mixed-effects Model for Repeated Measures (MMRM) was used to analyze the performance domain of PASAPQ score, with treatment and period as fixed effects, and patient as a random effect.||4.86|-13.63|0.347
71695121|NCT02452047|142905326|OTHER|Difference in percentages|Difference in FOR %|-7.3|||||TWO_SIDED|90.0|-27.5|21.4|||||Stratified Miettinen \& Nurminen method by infection type|||21.4|-27.5|
71695122|NCT02452047|142905327|OTHER|Difference in percentages|Difference in AE %|-10.3|||||TWO_SIDED|95.0|-33.1|18.0|||||Miettinen \& Nurminen method|||18.0|-33.1|
71695123|NCT02452047|142905328|OTHER|Difference in percentages|Difference in SAE %|-21.6|||||TWO_SIDED|95.0|-47.8|1.3|||||Miettinen \& Nurminen method|||1.3|-47.8|
71695124|NCT02452047|142905329|OTHER|Difference in percentages|Difference in drug-related AE %|-15.1|||||TWO_SIDED|95.0|-42.3|9.2|||||Miettinen \& Nurminen method|||9.2|-42.3|
71695125|NCT02452047|142905330|OTHER|Difference in percentages|Difference in drug-related SAE %|0.0|||||TWO_SIDED|95.0|-19.7|11.2|||||Miettinen \& Nurminen method|||11.2|-19.7|
71695126|NCT02452047|142905331|OTHER|Difference in percentages|Difference in discontinuation %|-18.8|||||TWO_SIDED|95.0|-43.3|-6.2|||||Miettinen \& Nurminen method|||-6.2|-43.3|
71695127|NCT02452047|142905332|OTHER|Difference in percentages|Difference in drug-related discon %|-12.5|||||TWO_SIDED|95.0|-36.3|-0.3|||||Miettinen \& Nurminen method|||-0.3|-36.3|
71695128|NCT02452047|142905333|OTHER|Difference in percentages|Difference in pyrexia %|0.4|||||TWO_SIDED|95.0|-25.2|19.7|||||Miettinen \& Nurminen method|||19.7|-25.2|
71695129|NCT02452047|142905333|OTHER|Difference in percentages|Difference blood creatinine inc %|-25.0|||||TWO_SIDED|95.0|-49.8|-10.1|||||Miettinen \& Nurminen method|||-10.1|-49.8|
71695130|NCT02452047|142905334|OTHER|Difference in Category 1 ECI %|Difference in Category 1 ECI %|-12.5||||0.047|TWO_SIDED|95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
71695131|NCT02452047|142905334|OTHER|Difference in Category 2 ECI %|Difference in Category 2 ECI %|-12.5||||0.047||95.0|-36.3|-0.3|||Miettinen and Nurminen method|||||-0.3|-36.3|0.047
71695132|NCT02452047|142905335|OTHER|Difference in percentages|Difference in nephrotoxicity %|-45.9||||0.002||95.0|-69.1|-18.4|||Fisher Exact||Miettinen \& Nurminen method|||-18.4|-69.1|0.002
71695133|NCT02452047|142905336|OTHER|Difference in Day 28 FCR %|Difference in Day 28 FCR %|26.3|||||TWO_SIDED|90.0|1.3|51.5|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.5|1.3|
71695134|NCT02452047|142905337|OTHER|Difference in mortality %|Difference in mortality %|-17.3|||||TWO_SIDED|90.0|-46.4|6.7|||||Miettinen and Nurminen method stratified by infection-site stratum|||6.7|-46.4|
71695135|NCT02452047|142905338|OTHER|Adjusted difference in OTX FCR %|Adjusted difference in OTX FCR %|33.9|||||TWO_SIDED|90.0|7.4|61.1|||||Miettinen and Nurminen method stratified by infection-site stratum|||61.1|7.4|
71695136|NCT02452047|142905339|OTHER|Adjusted difference in EOT FCR %|Adjusted difference in EOT FCR %|25.4|||||TWO_SIDED|90.0|3.1|53.6|||||Miettinen and Nurminen method stratified by infection-site stratum|||53.6|3.1|
71695137|NCT02452047|142905340|OTHER|Adjusted difference in EFU FCR %|Difference in EFU FCR %|24.7|||||TWO_SIDED|90.0|3.8|51.4|||||Miettinen and Nurminen method stratified by infection-site stratum|||51.4|3.8|
71695138|NCT02452047|142905341|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
71695139|NCT02452047|142905342|OTHER|Difference in percentages|Difference in FMR %|0.0|||||TWO_SIDED|90.0|-20.8|36.6|||||Miettinen \& Nurminen method|||36.6|-20.8|
71695140|NCT02452047|142905343|OTHER|Difference in percentages|Difference in FMR %|-27.3|||||TWO_SIDED|90.0|-52.8|12.8|||||Miettinen \& Nurminen method|||12.8|-52.8|
71695141|NCT00288912|142905344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.6||||0.007|TWO_SIDED|95.0|-1.0|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.2|-1.0|0.007
71695142|NCT00288912|142905344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4||||0.105|TWO_SIDED|95.0|-0.8|0.1|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.||0.1|-0.8|0.105
71695143|NCT00288912|142905345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2||||0.093|TWO_SIDED|95.0|-0.5|0.0|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.0|-0.5|0.093
71695144|NCT00288912|142905345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.43|TWO_SIDED|95.0|-0.2|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.2|-0.2|0.43
71695145|NCT00288912|142905346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1||||0.78|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.78
71695146|NCT00288912|142905346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0||||0.79|TWO_SIDED|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.4|-0.3|0.79
71695147|NCT00288912|142905347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.043|TWO_SIDED|95.0|0.0|0.8|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.8|0.0|0.043
71695148|NCT00288912|142905347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4||||0.066|TWO_SIDED|95.0|0.0|0.7|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.||0.7|0.0|0.066
71695149|NCT02026141|142905355|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|||||||<0.05
71695150|NCT01240382|142905434|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Median Difference (Final Values)|-0.03||||||95.0|-0.405|0.338|||l|||||0.338|-0.405|
71695151|NCT01240382|142905435|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-0.67||||0.01||95.0|-1.18|-0.67|||t-test, 2 sided|||||-0.67|-1.18|0.010
71695152|NCT02456727|142905439|SUPERIORITY||Mean Difference (Net)|-0.3714|STANDARD_ERROR_OF_MEAN|0.2039||0.0691|TWO_SIDED|95.0|-0.772|0.0291|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0291|-0.7720|0.0691
71695153|NCT02456727|142905440|SUPERIORITY||Mean Difference (Net)|-0.1631|STANDARD_ERROR_OF_MEAN|0.246||0.5077|TWO_SIDED|95.0|-0.6452|0.319|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.319|-0.6452|0.5077
71942885|NCT00420238|143407298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.13||||0.259|TWO_SIDED|95.0|0.57|7.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||7.94|0.57|0.259
71942886|NCT00420238|143407298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.54||||0.44||95.0|0.51|4.64|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||4.64|0.51|0.440
71942887|NCT00420238|143407298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.046||95.0|1.02|8.16|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||8.16|1.02|0.046
71942888|NCT00420238|143407298|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.85||||0.014||95.0|1.31|11.32|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.32|1.31|0.014
71942889|NCT00420238|143407300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.01||||0.204|TWO_SIDED|95.0|0.55|16.53|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||16.53|0.55|0.204
71942890|NCT00420238|143407300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
71942891|NCT00420238|143407300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.73||||0.121||95.0|0.71|19.69|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||19.69|0.71|0.121
71942892|NCT00420238|143407300|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36||||0.058||95.0|0.96|11.8|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||11.80|0.96|0.058
71942893|NCT00420238|143407302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.5||||0.287|TWO_SIDED|95.0|0.35|35.14|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||35.14|0.35|0.287
71942894|NCT00420238|143407302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.8||||0.169||95.0|0.51|44.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||44.94|0.51|0.169
71942895|NCT00420238|143407302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
71942896|NCT00420238|143407302|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.||23.07|0.87|0.073
71942897|NCT00420238|143407304|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95||||0.018|TWO_SIDED|95.0|-18.19|-1.72|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-1.72|-18.19|0.018
71942898|NCT00420238|143407305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.54||||0.089|TWO_SIDED|95.0|-18.4|1.33|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.33|-18.40|0.089
71942899|NCT00420238|143407305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.11||95.0|-17.89|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-17.89|0.110
71942900|NCT00420238|143407305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73||||0.004||95.0|-24.6|-4.86|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.86|-24.60|0.004
71942901|NCT00420238|143407305|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.27||||0.065||95.0|-19.14|0.59|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.||0.59|-19.14|0.065
71942902|NCT00420238|143407307|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.99||||0.002|TWO_SIDED|95.0|-17.7|-4.28|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-4.28|-17.70|0.002
71942903|NCT00420238|143407308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.33||||0.054|TWO_SIDED|95.0|-16.81|0.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||0.15|-16.81|0.054
71695154|NCT02456727|142905441|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0724|STANDARD_ERROR_OF_MEAN|0.0399||0.24|TWO_SIDED|95.0|-0.0058|0.1506|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1506|-0.0058|0.24
71695155|NCT02456727|142905442|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0531|STANDARD_ERROR_OF_MEAN|0.0487||0.17|TWO_SIDED|95.0|-0.0422|0.1485|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1485|-0.0422|0.17
71695156|NCT02456727|142905443|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0625|STANDARD_ERROR_OF_MEAN|0.0396||0.17|TWO_SIDED|95.0|-0.0151|0.1401|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1401|-0.0151|0.17
71695157|NCT02456727|142905444|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0882|STANDARD_ERROR_OF_MEAN|0.0488||0.4|TWO_SIDED|95.0|-0.0075|0.184|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.184|-0.0075|0.40
71695158|NCT02456727|142905445|SUPERIORITY||Mean Difference (Net)|-0.2643|STANDARD_ERROR_OF_MEAN|0.1782||0.1387|TWO_SIDED|95.0|-0.6136|0.0851|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.0851|-0.6136|0.1387
71695159|NCT02456727|142905446|SUPERIORITY||Mean Difference (Net)|-0.2334|STANDARD_ERROR_OF_MEAN|0.2124||0.2725|TWO_SIDED|95.0|-0.6497|0.1829|||ANCOVA|The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).|||0.1829|-0.6497|0.2725
71695160|NCT02456727|142905447|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0426|STANDARD_ERROR_OF_MEAN|0.0388||0.07|TWO_SIDED|95.0|-0.0334|0.1185|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1185|-0.0334|0.07
71695161|NCT02456727|142905448|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0283|STANDARD_ERROR_OF_MEAN|0.0477||0.07|TWO_SIDED|95.0|-0.0651|0.1218|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)|||0.1218|-0.0651|0.07
71695162|NCT02456727|142905449|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0262|STANDARD_ERROR_OF_MEAN|0.0356||0.02|TWO_SIDED|95.0|-0.0436|0.0961|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.0961|-0.0436|0.02
71695163|NCT02456727|142905450|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0323|STANDARD_ERROR_OF_MEAN|0.044||0.06|TWO_SIDED|95.0|-0.0539|0.1186|||Chi-squared||The estimated value is the difference of proportion of respondents (\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)|||0.1186|-0.0539|0.06
71695164|NCT02456727|142905451|SUPERIORITY||Mean Difference (Net)|-0.22|STANDARD_ERROR_OF_MEAN|0.15||0.1475|TWO_SIDED|95.0|-0.5288|0.0795|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.0795|-0.5288|0.1475
71695165|NCT02456727|142905452|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3038|TWO_SIDED|95.0|-0.546|0.1706|||t-test, 2 sided|The outcome is the change of PGIC from baseline to 12 weeks.|The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).|||0.1706|-0.546|0.3038
71695166|NCT02456727|142905453|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0251|STANDARD_ERROR_OF_MEAN|0.0392||0.03|TWO_SIDED|95.0|-0.0517|0.1018|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.1018|-0.0517|0.03
71695167|NCT02456727|142905454|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0018|STANDARD_ERROR_OF_MEAN|0.0481||0.02|TWO_SIDED|95.0|-0.0925|0.096|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 12 weeks between two treatment arms (Individual-Group)|||0.096|-0.0925|0.02
71695168|NCT02456727|142905455|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|-0.0104|STANDARD_ERROR_OF_MEAN|0.036||0|TWO_SIDED|95.0|-0.081|0.0602|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.0602|-0.081|0.00
71695169|NCT02456727|142905456|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0154|STANDARD_ERROR_OF_MEAN|0.0464||0.03|TWO_SIDED|95.0|-0.0755|0.1063|||Chi-squared||The estimated value is the difference of proportion of respondents (change post treatment\>=6) at 24 weeks between two treatment arms (Individual-Group)|||0.1063|-0.0755|0.03
71695170|NCT02456727|142905457|SUPERIORITY||Mean Difference (Net)|0.082|STANDARD_ERROR_OF_MEAN|0.5336||0.8778|TWO_SIDED|95.0|-0.9659|1.13|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.13|-0.9659|0.8778
71695171|NCT02456727|142905458|SUPERIORITY||Mean Difference (Net)|0.3623|STANDARD_ERROR_OF_MEAN|0.6252||0.5626|TWO_SIDED|95.0|-0.8667|1.5912|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.5912|-0.8667|0.5626
71695172|NCT02456727|142905459|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0362|STANDARD_ERROR_OF_MEAN|0.0399||0.05|TWO_SIDED|95.0|-0.0419|0.1144|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.1144|-0.0419|0.05
71695173|NCT02456727|142905460|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0647|STANDARD_ERROR_OF_MEAN|0.0466||0.22|TWO_SIDED|95.0|-0.0266|0.156|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 12 weeks between two treatment arms (Individual-Group)|||0.156|-0.0266|0.22
71695174|NCT02456727|142905461|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0523|STANDARD_ERROR_OF_MEAN|0.0415||0.12|TWO_SIDED|95.0|-0.029|0.1335|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1335|-0.029|0.12
71695175|NCT02456727|142905462|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0928|STANDARD_ERROR_OF_MEAN|0.0498||0.44|TWO_SIDED|95.0|-0.0047|0.1903|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=2) at 24 weeks between two treatment arms (Individual-Group)|||0.1903|-0.0047|0.44
71695176|NCT02456727|142905463|SUPERIORITY||Mean Difference (Net)|0.4831|STANDARD_ERROR_OF_MEAN|0.5753||0.4014|TWO_SIDED|95.0|-0.6468|1.6129|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.6129|-0.6468|0.4014
71695177|NCT02456727|142905464|SUPERIORITY||Mean Difference (Net)|0.6617|STANDARD_ERROR_OF_MEAN|0.647||0.307|TWO_SIDED|95.0|-0.61|1.9334|||ANCOVA|The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.|The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).|||1.9334|-0.61|0.307
71695178|NCT02456727|142905465|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0159|STANDARD_ERROR_OF_MEAN|0.0364||0.01|TWO_SIDED|95.0|-0.0555|0.0873|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.0873|-0.0555|0.01
71695179|NCT02456727|142905466|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0287|STANDARD_ERROR_OF_MEAN|0.0424||0.05|TWO_SIDED|95.0|-0.0544|0.1117|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 12 weeks between two treatment arms (Individual-Group)|||0.1117|-0.0544|0.05
71695180|NCT02456727|142905467|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0389|STANDARD_ERROR_OF_MEAN|0.0369||0.05|TWO_SIDED|95.0|-0.0335|0.1112|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1112|-0.0335|0.05
71695181|NCT02456727|142905468|NON_INFERIORITY|The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.|Risk Difference (RD)|0.0608|STANDARD_ERROR_OF_MEAN|0.0436||0.18|TWO_SIDED|95.0|-0.0247|0.1463|||Chi-squared||The estimated value is the difference of proportion of respondents (score change\>=5) at 24 weeks between two treatment arms (Individual-Group)|||0.1463|-0.0247|0.18
71695182|NCT02456727|142905469|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1658|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1658
71942904|NCT00420238|143407308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.02||||0.011||95.0|-19.5|-2.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.54|-19.50|0.011
71942905|NCT00420238|143407308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.75||||0.003||95.0|-21.23|-4.27|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-4.27|-21.23|0.003
71942906|NCT00420238|143407308|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.29|||<|0.001||95.0|-23.7|-6.82|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-6.82|-23.7|<0.001
71942907|NCT00420238|143407310|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.59||||0.039|TWO_SIDED|95.0|-18.69|-0.49|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.49|-18.69|0.039
71942908|NCT00420238|143407311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.28||||0.254|TWO_SIDED|95.0|-17.13|4.57|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.57|-17.13|0.254
71942909|NCT00420238|143407311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.17||||0.348||95.0|-16.02|5.68|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.68|-16.02|0.348
71942910|NCT00420238|143407311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.72||||0.014||95.0|-24.57|-2.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-2.88|-24.57|0.014
71942911|NCT00420238|143407311|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.69|||<|0.001||95.0|-30.54|-8.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-8.84|-30.54|<0.001
71942912|NCT00420238|143407313|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.49||||0.071|TWO_SIDED|95.0|-17.73|0.75|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.75|-17.73|0.071
71695183|NCT02456727|142905470|OTHER|The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.||||||0.1172|||||||McNemar|||Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.||||0.1172
71942913|NCT00420238|143407314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57||||0.511|TWO_SIDED|95.0|-14.31|7.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.17|-14.31|0.511
71942914|NCT00420238|143407314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.57||||0.401||95.0|-15.31|6.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||6.17|-15.31|0.401
71942915|NCT00420238|143407314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.45||||0.023||95.0|-23.19|-1.71|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-1.71|-23.19|0.023
71695184|NCT02456727|142905471|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0326|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0326
71695185|NCT02456727|142905472|OTHER|The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.||||||0.0026|||||||Wilcoxon signed rank test|||Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.||||0.0026
71695186|NCT02456727|142905473|SUPERIORITY|||||||0.129||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.129
71695187|NCT02456727|142905474|SUPERIORITY|||||||0.031||||||The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.|Wilcoxon (Mann-Whitney)|||||||0.031
71695188|NCT02456727|142905475|SUPERIORITY|Difference in change in proportion pre and post-treatment differs by treatment arm.||||||0.0059|||||||Mixed Models Analysis|||||||0.0059
71695189|NCT02456727|142905476|SUPERIORITY|||||||0.0385|||||||Mixed Models Analysis|||||||0.0385
71695190|NCT02974868|142905488|SUPERIORITY||Mean of Difference from Placebo|31.14|STANDARD_ERROR_OF_MEAN|6.25|<|0.0001|TWO_SIDED|95.0|18.78|43.5||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.50|18.78|<.0001
71695191|NCT02974868|142905488|SUPERIORITY||Mean of Difference from Placebo|49.18|STANDARD_ERROR_OF_MEAN|6.35|<|0.0001|TWO_SIDED|95.0|36.62|61.74||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||61.74|36.62|<.0001
71695192|NCT02974868|142905489|OTHER||Mean of Difference from Placebo|25.78|STANDARD_ERROR_OF_MEAN|10.64||0.0094|TWO_SIDED|90.0|7.98|43.58|||Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||43.58|7.98|0.0094
71695193|NCT02974868|142905489|OTHER||Mean of Difference from Placebo|46.61|STANDARD_ERROR_OF_MEAN|10.51|<|0.0001|TWO_SIDED|90.0|29.02|64.2|||Mixed Model Repeated Measure|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.||||64.20|29.02|<.0001
71695194|NCT02974868|142905494|OTHER||Difference in Percentage from Placebo|47.9|||<|0.0001|TWO_SIDED|90.0|34.2|60.7|||Chan and Zhang method|||||60.7|34.2|<.0001
71942916|NCT00420238|143407314|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.25||||0.01||95.0|-24.99|-3.51|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.51|-24.99|0.010
71695195|NCT02974868|142905494|OTHER||Difference in Percentage from Placebo|61.7|||<|0.0001|TWO_SIDED|90.0|48.2|73.6|||Chan and Zhang method|||||73.6|48.2|<.0001
71695196|NCT03575702|142905556|NON_INFERIORITY|The non-inferiority margin is considered as change in mean daily urination episodes of 0,8 episodes per day|Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.34|=|0.5595|ONE_SIDED|95.0||0.38|||ANCOVA|The number of urination episodes at the initiation of therapy is used as covariate, and the therapy group is used as a factor.||"The null hypothesis is that effect of Urotol according to the assessment of mean daily urination episodes exceeds effect of Uritos.~A sample containing of 222 patients (111 per study group) is considered sufficient to prove the alternative hypothesis at the significance level 0.025% and study power 80%. Given the expected drop out rate during the treatment period, the total number of patients to be randomized is 300 (150 in each group)."||0.38||=0.5595
71695197|NCT03575702|142905557|OTHER||||||=|0.0008|||||||ANCOVA|||||||=0.0008
71695198|NCT03575702|142905558|OTHER||||||=|0.0099|||||||ANCOVA|||||||=0.0099
71695199|NCT03575702|142905559|OTHER||||||<|0.0001|||||||ANCOVA|||||||<0.0001
71695200|NCT03575702|142905560|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 2||||||<0.0001
71695201|NCT03575702|142905560|OTHER||||||=|0.0236|||||||ANCOVA|Changes in number of daily incontinence episodes - week 4||||||=0.0236
71942917|NCT00420238|143407316|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.25||||0.127|TWO_SIDED|95.0|-12.03|1.53|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.||1.53|-12.03|0.127
71942918|NCT00420238|143407317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.914|TWO_SIDED|95.0|-8.23|7.38|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||7.38|-8.23|0.914
71695202|NCT03575702|142905560|OTHER||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 8||||||<0.0001
71695203|NCT03575702|142905560|OTHER||||||=|0.0018|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 2||||||=0.0018
71695204|NCT03575702|142905560|OTHER||||||=|0.3835|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 4||||||=0.3835
71695205|NCT03575702|142905560|OTHER||||||=|0.0088|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 8||||||=0.0088
71695206|NCT03575702|142905560|OTHER||||||=|0.0004|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 2||||||=0.0004
71695207|NCT03575702|142905560|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 4||||||<0.0001
71942919|NCT00420238|143407317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.4||||0.544||95.0|-10.21|5.41|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||5.41|-10.21|0.544
71942920|NCT00420238|143407317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.21||||0.039||95.0|-16.02|-0.4|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.40|-16.02|0.039
71942921|NCT00420238|143407317|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.54||||0.004||95.0|-19.35|-3.73|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.73|-19.35|0.004
71942922|NCT00420238|143407320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.86||||0.122|TWO_SIDED|95.0|-15.57|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||1.85|-15.57|0.122
71942923|NCT00420238|143407320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.45||||0.145||95.0|-15.16|2.26|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||2.26|-15.16|0.145
71942924|NCT00420238|143407320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.55||||0.005||95.0|-21.26|-3.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.84|-21.26|0.005
71942925|NCT00420238|143407320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-11.95||||0.008||95.0|-20.66|-3.24|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.24|-20.66|0.008
71942926|NCT00420238|143407324|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94||||0.139|TWO_SIDED|95.0|-13.84|1.96|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||1.96|-13.84|0.139
71942927|NCT00420238|143407325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89||||0.857|TWO_SIDED|95.0|-8.88|10.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||10.67|-8.88|0.857
71942928|NCT00420238|143407325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.1||||0.304||95.0|-14.88|4.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||4.67|-14.88|0.304
71942929|NCT00420238|143407325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.9||||0.047||95.0|-19.68|-0.13|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-0.13|-19.68|0.047
71942930|NCT00420238|143407325|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.65||||0.007||95.0|-23.43|-3.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.||-3.88|-23.43|0.007
71695208|NCT03575702|142905560|OTHER||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 8||||||<0.0001
71695209|NCT03575702|142905561|OTHER|||||||0.0008|||||||ANCOVA|||||||0.0008
71942931|NCT00420238|143407328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19||||0.003|TWO_SIDED|95.0|0.06|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.06|0.003
71942932|NCT00420238|143407328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.006|TWO_SIDED|95.0|0.05|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.31|0.05|0.006
71942933|NCT00420238|143407328|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.205|TWO_SIDED|95.0|-0.04|0.17|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.17|-0.04|0.205
71942934|NCT00420238|143407329|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.59||||0.03|TWO_SIDED|95.0|-4.93|-0.26|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||-0.26|-4.93|0.030
71942935|NCT00420238|143407330|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.035|TWO_SIDED|95.0|-0.45|-0.02|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.||-0.02|-0.45|0.035
71942936|NCT00420238|143407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09||||0.515|TWO_SIDED|95.0|-0.38|0.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.19|-0.38|0.515
71942937|NCT00420238|143407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14||||0.316||95.0|-0.43|0.14|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.14|-0.43|0.316
71942938|NCT00420238|143407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.008||95.0|-0.67|-0.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.10|-0.67|0.008
71942939|NCT00420238|143407331|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.011||95.0|-0.65|-0.08|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-0.08|-0.65|0.011
71942940|NCT00420238|143407343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.613|TWO_SIDED|95.0|-0.22|0.37|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.||0.37|-0.22|0.613
71942941|NCT00420238|143407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.07||||0.744|TWO_SIDED|95.0|-0.34|0.47|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.47|-0.34|0.744
71942942|NCT00420238|143407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.625||95.0|-0.5|0.3|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.30|-0.50|0.625
71942943|NCT00420238|143407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2||||0.325||95.0|-0.2|0.6|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.60|-0.20|0.325
71942944|NCT00420238|143407344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06||||0.76||95.0|-0.34|0.46|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||0.46|-0.34|0.760
71942945|NCT00420238|143407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.72||||0.49|TWO_SIDED|95.0|-18.35|8.91|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||8.91|-18.35|0.490
71942946|NCT00420238|143407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.651||95.0|-16.73|10.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||10.54|-16.73|0.651
71942947|NCT00420238|143407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.39||||0.84||95.0|-15.12|12.34|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||12.34|-15.12|0.840
71695210|NCT03575702|142905562|OTHER||||||=|0.1348|||||||ANCOVA|Week 2 changes||||||=0.1348
71695211|NCT03575702|142905562|OTHER||||||=|0.3199|||||||ANCOVA|Week 4 changes||||||=0.3199
71695212|NCT03575702|142905562|OTHER||||||=|0.9537|||||||ANCOVA|Week 8 changes||||||=0.9537
71942948|NCT00420238|143407346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.02||||0.562||95.0|-17.81|9.77|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||9.77|-17.81|0.562
71942949|NCT00420238|143407348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.73|||<|0.0001|TWO_SIDED|95.0|-19.44|-10.03|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.||-10.03|-19.44|<0.0001
71942950|NCT00420238|143407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.37|||<|0.0001|TWO_SIDED|95.0|-18.17|-6.58|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and atients as a random factor.||-6.58|-18.17|<0.0001
71942951|NCT00420238|143407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.45|||<|0.0001||95.0|-23.25|-11.65|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.65|-23.25|<0.0001
71942952|NCT00420238|143407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.95|||<|0.0001||95.0|-22.75|-11.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-11.15|-22.75|<0.0001
71942953|NCT00420238|143407349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.16|||<|0.0001||95.0|-23.96|-12.36|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.||-12.36|-23.96|<0.0001
71942954|NCT00420238|143407351|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.24|||<|0.0001|TWO_SIDED|95.0|-18.23|-8.25|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.||-8.25|-18.23|<0.0001
71942955|NCT00420238|143407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.32|||<|0.0001|TWO_SIDED|95.0|-20.55|-8.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.10|-20.55|<0.0001
71695213|NCT03575702|142905563|OTHER||||||=|0.5321|||||||t-test, 1 sided|Change week 12||||||=0.5321
71695214|NCT03575702|142905564|OTHER||||||=|0.4839|||||||t-test, 1 sided|Change week 12||||||=0.4839
71695215|NCT03575702|142905565|OTHER||||||=|0.86|||||||Chi-squared|||||||=0.86
71695216|NCT03903172|142905571|SUPERIORITY||||||=|0.25|||||||t-test, 2 sided|||Day 0||||=0.25
71695217|NCT03903172|142905571|SUPERIORITY||||||=|0.93|||||||t-test, 2 sided|||Day 1||||=.93
71942956|NCT00420238|143407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.98|||<|0.0001||95.0|-21.2|-8.76|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.76|-21.20|<0.0001
71942957|NCT00420238|143407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.19|||<|0.0001||95.0|-21.41|-8.96|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.96|-21.41|<0.0001
71942958|NCT00420238|143407352|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.41|||<|0.0001||95.0|-20.63|-8.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.||-8.19|-20.63|<0.0001
71942959|NCT00420238|143407355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.87||||0.184|TWO_SIDED|95.0|0.74|4.7|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||4.70|0.74|0.184
71942960|NCT00420238|143407355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.62||||0.036||95.0|1.06|6.46|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.46|1.06|0.036
71942961|NCT00420238|143407355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.96||||0.001||95.0|1.89|13.03|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||13.03|1.89|0.001
71942962|NCT00420238|143407355|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.38||||0.065||95.0|0.95|5.96|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||5.96|0.95|0.065
71942963|NCT00420238|143407357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|4.57||||0.004|TWO_SIDED|95.0|1.64|12.74|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||12.74|1.64|0.004
71942964|NCT00420238|143407357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.46||||0.054||95.0|0.99|6.12|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||6.12|0.99|0.054
71942965|NCT00420238|143407357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.26|||<|0.001||95.0|2.27|17.31|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||17.31|2.27|<0.001
71942966|NCT00420238|143407357|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.88||||0.025||95.0|1.14|7.27|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.||7.27|1.14|0.025
71942967|NCT03018249|143407433|SUPERIORITY|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||||||0.87
71942968|NCT03018249|143407434|SUPERIORITY||Mean Difference (Final Values)|2.7|||||TWO_SIDED|95.0|-25.0|30.0||||||||30|-25|
71695218|NCT03903172|142905572|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used acetominophen||||=1.0
71695219|NCT03903172|142905572|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used ibuprofen||||=1.0
71942969|NCT03018249|143407435|SUPERIORITY||Mean Difference (Final Values)|21.8|||||TWO_SIDED|95.0|-16.7|45.3||||||||45.3|-16.7|
71942970|NCT03966365|143407472|OTHER|||||||0.706|||||||Wilcoxon (Mann-Whitney)|||||||0.706
71942971|NCT03966365|143407473|OTHER|||||||0.622|||||||Wilcoxon (Mann-Whitney)|||||||0.622
71942972|NCT03966365|143407474|OTHER|||||||0.081|||||||Chi-squared, Corrected|||Green lissamine treatment groups||||0.081
71942973|NCT03966365|143407474|OTHER|||||||0.49|||||||Chi-squared, Corrected|||Fluorescein treatment groups||||0.490
71942974|NCT03966365|143407475|OTHER|||||||0.253|||||||Wilcoxon (Mann-Whitney)|||||||0.253
71942975|NCT03966365|143407476|OTHER|||||||0.031|||||||Chi-squared, Corrected|||||||0.031
71942976|NCT03966365|143407478|OTHER|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||||||0.651
71942977|NCT01523899|143407481|SUPERIORITY||Mean Difference (Final Values)|0.145|||||TWO_SIDED|95.0||||Pearson chi squared, Fisher exact, 2 sample t-tests||||||||
71942978|NCT01523899|143407482|SUPERIORITY||||||>|0.05|||||||Chi-squared|||||||>0.05
71942979|NCT00824265|143407484|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.67||||0.0032|TWO_SIDED|95.0|0.51|0.88|||Log Rank|||||0.88|0.51|0.0032
71942980|NCT00824265|143407485|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.8||||0.1427|TWO_SIDED|95.0|0.59|1.09|||Log Rank|||||1.09|0.59|0.1427
71942981|NCT00824265|143407486|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.08||||0.449|TWO_SIDED|95.0|0.85|1.37|||Log Rank|||||1.37|0.85|0.4490
71942982|NCT00824265|143407487|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.77||||0.0878|TWO_SIDED|95.0|0.56|1.05|||Log Rank|||||1.05|0.56|0.0878
71942983|NCT00824265|143407488|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0036|TWO_SIDED|95.0|0.45|0.87|||Log Rank|||||0.87|0.45|0.0036
71942984|NCT00824265|143407489|SUPERIORITY_OR_OTHER_LEGACY|Participants in the ITT population|Hazard Ratio (HR)|0.77||||0.1143|TWO_SIDED|95.0|0.55|1.08|||Log Rank|||||1.08|0.55|0.1143
71942985|NCT00824265|143407489|SUPERIORITY_OR_OTHER_LEGACY|Participants who took anti-cancer therapies|Hazard Ratio (HR)|0.67||||0.0109|TWO_SIDED|95.0|0.48|0.94|||Log Rank|||||0.94|0.48|0.0109
71942986|NCT00824265|143407492|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71942987|NCT00824265|143407493|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0166|||||||Cochran-Mantel-Haenszel|||||||0.0166
71942988|NCT01402947|143407515|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.013|||||TWO_SIDED|90.0|0.933|1.1|||ANOVA|||||1.100|0.933|
71942989|NCT01402947|143407516|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.999|||||TWO_SIDED|90.0|0.893|1.117|||ANOVA|||||1.117|0.893|
71942990|NCT02801877|143407519|SUPERIORITY|||||||0.3|||||||Log Rank|Chi square= 4.1 on 3 degrees of freedom||Log-rank test of adherence, defined as time to last engagement with mobile application suite.||||0.3
71942991|NCT02801877|143407520|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|F(3, 835)=0.19||Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.90
71942992|NCT02801877|143407521|SUPERIORITY|||||||0.53|||||||Mixed Models Analysis|F(3, 835)=0.73||Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach\*time, hub, and hub\*time.||||0.53
71942993|NCT04349917|143407523|SUPERIORITY|||||||0.532|||||||t-test, 2 sided|||||||0.532
71942994|NCT04349917|143407524|SUPERIORITY|||||||0.579|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.579
71942995|NCT04349917|143407524|SUPERIORITY|||||||0.034|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.034
71942996|NCT04349917|143407525|SUPERIORITY|||||||0.296|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG regular task||||0.296
71942997|NCT04349917|143407525|SUPERIORITY|||||||0.169|||||||t-test, 2 sided|||Analysis for reconfiguration between rest and GNG reward task||||0.169
71942998|NCT04349917|143407526|SUPERIORITY|||||||0.118|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular commission rate||||0.118
71942999|NCT04349917|143407526|SUPERIORITY|||||||0.022|||||||Pearson correlation|||Change in rest modularity vs change in GNG regular omission rate||||0.022
71943000|NCT04349917|143407526|SUPERIORITY|||||||0.22|||||||Pearson correlation|||Change in rest modularity vs Change in GNG regular RT Variability||||0.220
71943001|NCT04349917|143407526|SUPERIORITY|||||||0.496|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward commission rate||||0.496
71943002|NCT04349917|143407526|SUPERIORITY|||||||0.343|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward omission rate||||0.343
71943003|NCT04349917|143407526|SUPERIORITY|||||||0.988|||||||Pearson correlation|||Change in rest modularity vs change in GNG reward RT variability||||0.988
71943004|NCT04349917|143407526|SUPERIORITY|||||||0.892|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular commission rate||||0.892
71943005|NCT04349917|143407526|SUPERIORITY|||||||0.473|||||||Pearson correlation|||Change in GNG regular modularity vs change in GNG regular omission rate||||0.473
71943006|NCT04349917|143407526|SUPERIORITY|||||||0.409|||||||Pearson correlation|||Change in GNG regular modularity vs Change in GNG regular RT Variability||||0.409
71943007|NCT04349917|143407526|SUPERIORITY|||||||0.351|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward commission rate||||0.351
71943008|NCT04349917|143407526|SUPERIORITY|||||||0.238|||||||Pearson correlation|||Change in GNG reward modularity vs change in GNG reward omission rate||||0.238
71943009|NCT04349917|143407526|SUPERIORITY|||||||0.909|||||||Pearson correlation|||Change in GNG reward modularity vs Change in GNG reward RT Variability||||0.909
71943010|NCT04349917|143407527|SUPERIORITY|||||||0.806|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.806
71943011|NCT04349917|143407527|SUPERIORITY|||||||0.003|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.003
71943012|NCT04349917|143407528|SUPERIORITY|||||||0.093|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.093
71943013|NCT04349917|143407528|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
71943014|NCT04349917|143407529|SUPERIORITY|||||||0.075|||||||t-test, 2 sided|||Analysis for GNG regular task||||0.075
71943015|NCT04349917|143407529|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||Analysis for GNG reward task||||0.0001
71943016|NCT01507051|143407578|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|2.793|||<|0.0001||90.0|2.633|2.962|||ANOVA|||||2.962|2.633|<0.0001
71943017|NCT01507051|143407579|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio|6.151|||<|0.0001||90.0|5.598|6.759|||ANOVA|||||6.759|5.598|<0.0001
71943018|NCT01507051|143407606|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.17||||0.5008||95.0|82.2|110.2|||ANOVA|||||110.2|82.20|0.5008
71943019|NCT01507051|143407607|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|99.46||||0.9429||95.0|85.47|115.7|||ANOVA|||||115.7|85.47|0.9429
71943020|NCT01507051|143407608|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|100.4||||0.9525||95.0|88.0|114.5|||ANOVA|||||114.5|88.00|0.9525
71943021|NCT01507051|143407609|SUPERIORITY_OR_OTHER||Geometric LS-Mean Ratio (%)|95.87||||0.4397||95.0|85.99|106.9|||ANOVA|||||106.9|85.99|0.4397
71943022|NCT02653664|143407650|SUPERIORITY|||||||0.39||||||Statistical significance was set at p=.05|ANOVA|||Based on our prior work comparing similar interventions, assuming decreases in average pain intensity of 0.3 points (on a 0-10 scale) for ED, between 0.8 to 1.4 points for HYP, and between 0.6 to 1 for MM, with standard deviations (SD) ranging from 0.15 to 1, significance level of 0.05, and using ANOVA as the statistical method, we calculated that 80 participants per arm at immediate post-treatment would provide at least 80% power to detect between-groups differences as specified.||||.39
71943023|NCT02653664|143407651|SUPERIORITY|||||||0.05||||||Statistical significance was set at p=.05.|ANOVA|||||||.05
71943024|NCT02653664|143407652|SUPERIORITY||||||<|0.001||||||Statistical significance was set at p= .05|ANOVA|||||||<.001
71943025|NCT00485472|143407653|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.36||||0.5438||95.0|-5.3|10.02|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||10.02|-5.30|0.5438
71943026|NCT00485472|143407654|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.83||||0.2022||95.0|-2.62|12.28|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||12.28|-2.62|0.2022
71943027|NCT00485472|143407655|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.79||||0.665||95.0|-6.36|9.93|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||9.93|-6.36|0.6650
71943028|NCT00485472|143407656|SUPERIORITY_OR_OTHER||Mean Difference (Net)|10.74||||0.3445||95.0|-11.65|33.13|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.||33.13|-11.65|0.3445
71943029|NCT00485472|143407658|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.488||||0.0418||95.0|0.245|0.974|||Likelihood ratio test|||Analysis of 'response' based on a likelihood ratio test with treatment and pooled site as factors.||0.974|0.245|0.0418
71943030|NCT00365300|143407692|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.004||||1|||||||Fisher Exact|||||||1.0
71943031|NCT01287013|143407698|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71943032|NCT01287013|143407699|SUPERIORITY_OR_OTHER||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||||||<0.001
71943033|NCT01287013|143407700|OTHER||||||<|0.04|||||||t-test, 2 sided|||||||<0.04
71943034|NCT01287013|143407701|SUPERIORITY_OR_OTHER||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71943035|NCT01287013|143407702|SUPERIORITY_OR_OTHER||||||=|0.67|||||||t-test, 2 sided|||||||=0.67
71943036|NCT01179048|143407703|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.|Hazard Ratio (HR)|0.868|||<|0.001|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio \>=1.3).|Regression, Cox|||The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR \>=1.3 against Ha: HR \<1.3 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|<0.001
71943037|NCT01179048|143407703|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.868||||0.005|TWO_SIDED|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio\>=1.0).|Regression, Cox|||If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR \>=1.0 against Ha: HR \<1.0 was less than 2.5% (or equivalent to 5% in two-sided test).||0.968|0.778|0.005
71943038|NCT01179048|143407704|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.881|||||TWO_SIDED|95.0|0.807|0.962|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.962|0.807|
71943039|NCT01179048|143407705|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.847|||||TWO_SIDED|95.0|0.739|0.971|||Regression, Cox|The analysis was done using a Cox regression model with treatment as a fixed factor including all randomised subjects.||||0.971|0.739|
71943040|NCT01179048|143407706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.783|||||TWO_SIDED|95.0|0.656|0.934|||Regression, Cox|||Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.||0.934|0.656|
71943041|NCT01179048|143407706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.894|||||TWO_SIDED|95.0|0.721|1.107|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor||1.107|0.721|
71943042|NCT01179048|143407706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.878|||||TWO_SIDED|95.0|0.747|1.031|||Regression, Cox|||Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor||1.031|0.747|
71943043|NCT01179048|143407706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.98|||||TWO_SIDED|95.0|0.763|1.258|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor||1.258|0.763|
71943044|NCT01179048|143407706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.912|||||TWO_SIDED|95.0|0.797|1.044|||Regression, Cox|||Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor||1.044|0.797|
71943045|NCT01179048|143407706|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.872|||||TWO_SIDED|95.0|0.727|1.046|||Regression, Cox|||Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor||1.046|0.727|
71943046|NCT01179048|143407707|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.841|||||TWO_SIDED|95.0|0.73|0.969|||Regression, Cox|||Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.||0.969|0.730|
71943047|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.782|||||TWO_SIDED|95.0|0.666|0.918|||Regression, Cox|||Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.||0.918|0.666|
71943048|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.738|||||TWO_SIDED|95.0|0.602|0.905|||Regression, Cox|||Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.||0.905|0.602|
71943049|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.667|1.189|||Regression, Cox|||Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.||1.189|0.667|
71943050|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.869|||||TWO_SIDED|95.0|0.607|1.244|||Regression, Cox|||Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.||1.244|0.607|
71943051|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.593|||||TWO_SIDED|95.0|0.521|4.869|||Regression, Cox|||Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.||4.869|0.521|
71943052|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.149|||||TWO_SIDED|95.0|0.869|1.519|||Regression, Cox|||Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.||1.519|0.869|
71695220|NCT03903172|142905572|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used Cyclobenzaprine||||=1.0
71943053|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.159|||||TWO_SIDED|95.0|0.869|1.546|||Regression, Cox|||Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.||1.546|0.869|
71943054|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.335|||||TWO_SIDED|95.0|0.004|30.847|||Regression, Cox|||Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.||30.847|0.004|
71943055|NCT01179048|143407708|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.454|||||TWO_SIDED|95.0|0.845|2.502|||Regression, Cox|||Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.||2.502|0.845|
71943056|NCT03203447|143407711|SUPERIORITY||Difference in percentages|-7.1||||0.191|TWO_SIDED|95.0|-17.9|3.6||The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.|Cochran-Mantel-Haenszel|The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.|Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.|Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.||3.6|-17.9|0.191
71695221|NCT03903172|142905572|SUPERIORITY||||||=|0.11|||||||Fisher Exact|||Used Methocarbamol||||=.11
71695222|NCT03903172|142905572|SUPERIORITY||||||=|0.49|||||||Fisher Exact|||Used Hydroxyzine||||=.49
71695223|NCT03903172|142905572|SUPERIORITY||||||=|1|||||||Fisher Exact|||Used an 'Other' non-pharmacologic medication||||=1.0
71695224|NCT03903172|142905573|SUPERIORITY||||||=|1|||||||Fisher Exact|||Any narcotic medication used||||=1.0
71695225|NCT01545388|142905574|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.678|||<|0.001|TWO_SIDED|95.0|-0.868|-0.489|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.489|-0.868|<0.001
71695226|NCT01545388|142905574|SUPERIORITY_OR_OTHER||Difference in least squares means|-0.525|||<|0.001|TWO_SIDED|95.0|-0.713|-0.337|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-0.337|-0.713|<0.001
71695227|NCT01545388|142905574|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin (Δ) is set as 0.3% to show the non-inferiority of metformin 500 mg q.d. to metformin 250 mg b.i.d.|Difference in least squares means|0.153|||||TWO_SIDED|95.0|0.0|0.306||||||||0.306|0.000|
71695228|NCT01545388|142905575|SUPERIORITY_OR_OTHER||Difference in least squares means|-18.59|||<|0.001|TWO_SIDED|95.0|-25.94|-11.24|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-11.24|-25.94|<0.001
71695229|NCT01545388|142905575|SUPERIORITY_OR_OTHER||Difference in least squares means|-16.34|||<|0.001|TWO_SIDED|95.0|-23.62|-9.06|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.||||-9.06|-23.62|<0.001
71695230|NCT01545388|142905575|SUPERIORITY_OR_OTHER||Difference in least squares mean|2.25|||||TWO_SIDED|95.0|-3.63|8.14||||||||8.14|-3.63|
71943057|NCT02627924|143407714|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
71943058|NCT02627924|143407715|OTHER||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.||||||<0.0001
71695231|NCT01255163|142905578|OTHER|||||||0.016||||||threshold for significance (p \< 0.05)|Fisher Exact|||||||0.016
71695232|NCT01255163|142905579|OTHER|||||||0.098||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects Group \* VisitLong F (6, 52.008) = 1.902, p = 0.098"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED MMSE.tot BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.098
71695233|NCT01255163|142905580|OTHER|||||||0.295||||||"Threshold for statistical significance p \< 0.05.~Type III Tests of Fixed Effects for Group\*VisitLong F (6, 52.281) = 1.254, p = 0.295"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED ADAS70 BY Group Sex VisitLong WITH Age~* CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~* FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3)~* METHOD=REML~* PRINT=SOLUTION~* REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1)~* EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~* EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.295
71695234|NCT01255163|142905581|OTHER|||||||0.141||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (6, 47.485) = 1.704, p = 0.141|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.141
71695235|NCT01255163|142905582|OTHER|||||||0.031||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects: Group \* VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR.sob BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.031
71943059|NCT02627924|143407717|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12||||<0.0001
71943060|NCT02627924|143407717|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24||||<0.0001
71943061|NCT02627924|143407717|OTHER|||||||0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12||||0.0001
71943062|NCT02627924|143407717|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24||||<0.0001
71943063|NCT02627924|143407718|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks||||<0.0001
71943064|NCT02627924|143407718|OTHER||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks||||<0.0001
71943065|NCT02627924|143407719|OTHER|||||||0.0098|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12||||0.0098
71943066|NCT02627924|143407719|OTHER|||||||0.0015|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24||||0.0015
71943067|NCT02627924|143407719|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12||||<0.0001
71943068|NCT02627924|143407719|OTHER||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24||||<0.0001
71943069|NCT00528606|143407726|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.||||<0.001
71943070|NCT00959660|143407740|SUPERIORITY||||||<|0.001||||||Main effects analysis with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
71943071|NCT00959660|143407740|SUPERIORITY||||||<|0.001||||||Main effects analysis with Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||<0.001
71943072|NCT00959660|143407741|SUPERIORITY|||||||0.004||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.004
71943073|NCT00959660|143407741|SUPERIORITY|||||||0.43||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||||||0.43
71943074|NCT00959660|143407742|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||<0.001
71943075|NCT00959660|143407742|SUPERIORITY|||||||0.001||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass||||0.001
71943076|NCT00959660|143407742|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||<0.001
71943077|NCT00959660|143407742|SUPERIORITY|||||||0.25||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass||||0.25
71943078|NCT00959660|143407743|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||<0.001
71943079|NCT00959660|143407743|SUPERIORITY|||||||0.26||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat||||0.26
71943080|NCT00959660|143407743|SUPERIORITY||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||<0.001
71943081|NCT00959660|143407743|SUPERIORITY|||||||0.26||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle||||0.26
71943082|NCT01297348|143407744|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.01|||||TWO_SIDED|95.0|1.23|3.29||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95 percent (%) confidence interval (CI) was reported for current users.||3.29|1.23|
71943083|NCT01297348|143407744|SUPERIORITY_OR_OTHER||Incidence rate ratio|2.99|||||TWO_SIDED|95.0|0.39|22.8||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95% CI was reported for past users.||22.80|0.39|
71943084|NCT01297348|143407744|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.49|||||TWO_SIDED|95.0|2.02|6.02||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for current users.||6.02|2.02|
71943085|NCT01297348|143407744|SUPERIORITY_OR_OTHER||Incidence rate ratio|3.07|||||TWO_SIDED|95.0|0.34|27.47||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for past users.||27.47|0.34|
71943086|NCT01297348|143407745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.51|||||TWO_SIDED|95.0|0.85|2.67||||||Current user, case and matched control: Odds ratio (Lybrel/EE-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||2.67|0.85|
71943087|NCT01297348|143407745|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.53|||||TWO_SIDED|95.0|0.98|6.54||||||Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).||6.54|0.98|
71943088|NCT01520909|143407746|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|17.96|||<|0.001|TWO_SIDED|95.0|2.29|140.93|||Cochran-Mantel-Haenszel|The proportion of participants achieving platelet counts \>=50 Gi/L for those participants receiving eltrombopag versus placebo was compared.||Indicated significance at the 5% (two-sided) level of significance||140.93|2.29|<0.001
71943089|NCT01520909|143407747|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|25.33|||<|0.001|TWO_SIDED|95.0|8.15|78.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized linear mixed model||||78.73|8.15|<0.001
71943090|NCT00050778|143407835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.24||||0.0006|TWO_SIDED|95.0|0.11|0.545||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.545|0.110|0.0006
71943091|NCT00050778|143407835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.31||||0.0021|TWO_SIDED|95.0|0.151|0.658||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.658|0.151|0.0021
71943092|NCT00050778|143407835|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.152|0.515|||Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.||0.515|0.152|<0.0001
71943093|NCT00050778|143407836|SUPERIORITY_OR_OTHER||Rate ratio|0.33|||<|0.0001|TWO_SIDED|95.0|0.196|0.552||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.552|0.196|<0.0001
71943094|NCT00050778|143407836|SUPERIORITY_OR_OTHER||Rate ratio|0.23|||<|0.0001|TWO_SIDED|95.0|0.126|0.431||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.431|0.126|<0.0001
71943095|NCT00050778|143407836|SUPERIORITY_OR_OTHER||Rate ratio|0.28|||<|0.0001|TWO_SIDED|95.0|0.176|0.441|||Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).||0.441|0.176|<0.0001
71943096|NCT00050778|143407837|SUPERIORITY_OR_OTHER||Treatment effect|62.64||||0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||0.0001
71943097|NCT00050778|143407837|SUPERIORITY_OR_OTHER||Treatment effect|76.71|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
71943098|NCT00050778|143407837|SUPERIORITY_OR_OTHER||Treatment effect|70.13|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.||||<0.0001
71943099|NCT00050778|143407838|SUPERIORITY_OR_OTHER|||||||0.0885|||||||ANCOVA|||Ranked analysis of covariance (ANCOVA) model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0885
71943100|NCT00050778|143407838|SUPERIORITY_OR_OTHER|||||||0.0195|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0195
71943101|NCT00050778|143407838|SUPERIORITY_OR_OTHER|||||||0.0215|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.||||0.0215
71943102|NCT00050778|143407839|SUPERIORITY_OR_OTHER|||||||0.3077|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3077
71943103|NCT00050778|143407839|SUPERIORITY_OR_OTHER|||||||0.3632|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.3632
71943104|NCT00050778|143407839|SUPERIORITY_OR_OTHER|||||||0.2758|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.||||0.2758
71943105|NCT00064753|143407847|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.99||||0.93|TWO_SIDED|95.0|0.84|1.17||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.17|0.84|0.93
71943106|NCT00064753|143407848|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.15||||0.19|TWO_SIDED|95.0|0.93|1.43||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.43|0.93|0.19
71943107|NCT00064753|143407849|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.04||||0.67|TWO_SIDED|95.0|0.86|1.26||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.26|0.86|0.67
71943108|NCT00064753|143407850|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.08||||0.61|TWO_SIDED|95.0|0.8|1.45||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.45|0.80|0.61
71943109|NCT00064753|143407851|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.12||||0.64|TWO_SIDED|95.0|0.69|1.81||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||1.81|0.69|0.64
71943110|NCT00064753|143407852|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8||||0.66|TWO_SIDED|95.0|0.3|2.15||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox|||||2.15|0.30|0.66
71943111|NCT00064753|143407853|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.84||||0.28|TWO_SIDED|95.0|0.62|1.15|||Regression, Cox|||||1.15|0.62|0.28
71943112|NCT00064753|143407854|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.7|TWO_SIDED|95.0|0.73|1.23|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.23|0.73|0.70
71943113|NCT00064753|143407855|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.49|TWO_SIDED|95.0|0.79|1.65|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||1.65|0.79|0.49
71943114|NCT00064753|143407856|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.14||||0.78|TWO_SIDED|95.0|0.46|2.8|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.80|0.46|0.78
71943115|NCT00064753|143407857|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.61||||0.5|TWO_SIDED|95.0|0.15|2.57|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||2.57|0.15|0.50
71943116|NCT00064753|143407858|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.3||||0.6|TWO_SIDED|95.0|0.48|3.5|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country||||3.50|0.48|0.60
71943117|NCT03834870|143407860|OTHER||Percentage of enrolled from eligible|84.05|||||TWO_SIDED|95.0|81.98|86.1||||||||86.10|81.98|
71943118|NCT03834870|143407861|OTHER||Percentage of enrolled from eligible|99.01|||||TWO_SIDED|95.0|98.4|99.6||||||||99.60|98.40|
71943119|NCT00813293|143407871|SUPERIORITY|||||||0.794|||||||Wilcoxon (Mann-Whitney)|||Assuming the two trial arms were independent, the standard deviation was 0.5cm for both arms and a sample size of 16 evaluable patients (8 per arm), the study had an 84% power at a 5% (two-sided) significance level to detect 0.8cm difference in ablation zone size. In order to allow a 20% drop-out rate, a total of 20 subjects were accrued.||||.794
71943120|NCT01544127|143407876|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.19||0.054|TWO_SIDED|95.0|0.31|1.12||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|"MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||1.12|0.31|.054
71943121|NCT01544127|143407876|SUPERIORITY||Odds Ratio (OR)|0.6|STANDARD_ERROR_OF_MEAN|0.26||0.12|TWO_SIDED|95.0|0.26|1.4||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI+TAU vs. TAU Alone||1.40|0.26|0.12
71943122|NCT01544127|143407876|SUPERIORITY||Odds Ratio (OR)|0.59|STANDARD_ERROR_OF_MEAN|0.22||0.08|TWO_SIDED|95.0|0.28|1.24||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI-R + TAU vs. TAU Alone||1.24|0.28|0.08
71943123|NCT01544127|143407877|SUPERIORITY||Beta|0.06|STANDARD_ERROR_OF_MEAN|0.11||0.3|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||"MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."||||0.30
71943124|NCT01544127|143407877|SUPERIORITY||Beta|0.09|STANDARD_ERROR_OF_MEAN|0.12||0.23|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI vs. TAU Alone||||0.23
71943125|NCT01544127|143407877|SUPERIORITY||Beta|0.01|STANDARD_ERROR_OF_MEAN|0.13||0.46|TWO_SIDED|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI-R vs. TAU Alone||||0.46
71943126|NCT01544127|143407878|SUPERIORITY||Odds Ratio (OR)|1.03|STANDARD_ERROR_OF_MEAN|0.65||0.96|TWO_SIDED|0.95|0.3|3.54||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI + TAU vs. TAU Alone||3.54|0.30|0.96
71943127|NCT01544127|143407878|SUPERIORITY||Odds Ratio (OR)|0.68|STANDARD_ERROR_OF_MEAN|0.38||0.5|TWO_SIDED|95.0|0.23|2.06||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI-R + TAU vs. TAU Alone||2.06|0.23|0.50
71943128|NCT01544127|143407879|SUPERIORITY||Cox Proportional Hazard|1.69|STANDARD_ERROR_OF_MEAN|0.91||0.31|TWO_SIDED|95.0|0.59|4.88||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI + TAU vs. TAU Alone||4.88|0.59|0.31
71943129|NCT01544127|143407879|SUPERIORITY||Cox Proportional Hazard|0.49|STANDARD_ERROR_OF_MEAN|0.39||0.24|TWO_SIDED|95.0|0.1|2.31||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI-R vs. TAU Alone||2.31|0.10|0.24
71695236|NCT01255163|142905583|OTHER|||||||0.703||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.251) = 0.360, p = 0.703.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED TAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.703
71695237|NCT01255163|142905584|OTHER|||||||0.845||||||Threshold for statistical significance p \< 0.05. Type III Tests of Fixed Effects Group \* VisitLong F (2, 15.828) = 0.170, p = 0.845.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED pTAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.845
71943130|NCT01544127|143407879|SUPERIORITY||Cox Proportional Hazard|0.29|STANDARD_ERROR_OF_MEAN|0.23||0.1|TWO_SIDED|95.0|0.06|1.43||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||"MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU."||1.43|0.06|0.10
71943131|NCT00533273|143407880|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
71943132|NCT00533273|143407881|SUPERIORITY||||||<|0.001|||||||Cochran-Mantel-Haenszel|||||||<.001
71943133|NCT00533273|143407882|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71943134|NCT00533273|143407883|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71943135|NCT00533273|143407885|SUPERIORITY|||||||0.014|||||||Cochran-Mantel-Haenszel|||||||.014
71943136|NCT00533273|143407886|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<.0001
71943137|NCT00533273|143407887|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71943138|NCT00533273|143407888|SUPERIORITY||||||<|0.001|||||||ANOVA|||||||<.001
71943139|NCT02870920|143407898|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.07|TWO_SIDED|90.0|0.54|0.97|||Log Rank|||||0.97|0.54|0.07
71943140|NCT02870920|143407899|SUPERIORITY||Hazard Ratio (HR)|1.01||||0.97|TWO_SIDED|90.0|0.76|1.34|||Log Rank|||||1.34|0.76|0.97
71943141|NCT00454909|143407910|SUPERIORITY||Difference in percentage|11.2|||||TWO_SIDED|95.0|3.87|19.18||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.||19.18|3.87|
71943142|NCT00454909|143407910|SUPERIORITY||Difference in percentage|-2.77|||||TWO_SIDED|95.0|-5.08|0.4||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.||0.40|-5.08|
71695238|NCT01255163|142905585|OTHER|||||||0.018||||||Type III Tests of Fixed Effects: Group \* VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED Ab42 BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.018
71695239|NCT01255163|142905586|OTHER|||||||0.009||||||Type III Tests of Fixed Effects: Group \* VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED BMI BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group\*VisitLong \| SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong \| SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group\*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."|||0.009
71695240|NCT02495389|142905588|SUPERIORITY||Mean Difference (Final Values)|23.96|STANDARD_ERROR_OF_MEAN|2.7741|<|0.0001|TWO_SIDED|95.0|18.35|29.57|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score after 12 weeks of therapy.||29.57|18.35|<.0001
71695241|NCT02495389|142905589|SUPERIORITY||Mean Difference (Final Values)|-51.62|STANDARD_ERROR_OF_MEAN|6.1584|<|0.0001|TWO_SIDED|95.0|-64.04|-39.2|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Urinary Distress Inventory score after 12 weeks of therapy.||-39.20|-64.04|<.0001
71695242|NCT02495389|142905590|SUPERIORITY||Mean Difference (Final Values)|-29.3|STANDARD_ERROR_OF_MEAN|5.4701|<|0.0001|TWO_SIDED|95.0|-40.33|-18.27|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Pelvic Organ Prolapse Distress Inventory score after 12 weeks of therapy.||-18.27|-40.33|<.0001
71695243|NCT02495389|142905591|SUPERIORITY||Mean Difference (Final Values)|-32.0|STANDARD_ERROR_OF_MEAN|6.1226|<|0.0001|TWO_SIDED|95.0|-44.35|-19.65|||t-test, 2 sided|A two-sided paired t-test was used for this analysis.||The null hypothesis is that there is no change in patients' baseline Colo-Rectal-Anal Distress Inventory score after 12 weeks of therapy.||-19.65|-44.35|<.0001
71695244|NCT03834493|142905614|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.6621|TWO_SIDED|95.0|0.88|1.22|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.22|0.88|0.6621
71943143|NCT00454909|143407910|SUPERIORITY||Difference in percentage|14.93|||||TWO_SIDED|95.0|8.24|22.71||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.||22.71|8.24|
71943144|NCT00454909|143407910|SUPERIORITY||Difference in percentage|13.4|||||TWO_SIDED|95.0|7.9|20.1||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.||20.10|7.90|
71695245|NCT03834493|142905615|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.4073|TWO_SIDED|95.0|0.84|1.14|||Log Rank||Stratified Cox model with Efron's tie handling method|||1.14|0.84|0.4073
71695246|NCT03834493|142905616|OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.83|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.83|
71695247|NCT03834493|142905617|OTHER||Difference in Percentage|3.4|||||TWO_SIDED|95.0|-1.5|8.3|||||Stratified Miettinen and Nurminen method|||8.3|-1.5|
71695248|NCT03834493|142905618|OTHER||Difference in Percentage|0.3|||||TWO_SIDED|95.0|-3.4|4.1|||||Stratified Miettinen and Nurminen method|||4.1|-3.4|
71695249|NCT03834493|142905619|OTHER||Difference in Percentage|2.9|||||TWO_SIDED|95.0|-0.2|6.1|||||Stratified Miettinen and Nurminen method|||6.1|-0.2|
71695250|NCT03834493|142905621|OTHER||Hazard Ratio (HR)|0.99|||||TWO_SIDED|95.0|0.86|1.15|||||Stratified Cox model with Efron's tie handling method|||1.15|0.86|
71695251|NCT03834493|142905622|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.74|1.09|||||Stratified Cox model with Efron's tie handling method|||1.09|0.74|
71695252|NCT03834493|142905623|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.82|1.35|||||Stratified Cox model with Efron's tie handling method|||1.35|0.82|
71695253|NCT03834493|142905624|OTHER||Hazard Ratio (HR)|1.13|||||TWO_SIDED|95.0|0.85|1.51|||||Stratified Cox model with Efron's tie handling method|||1.51|0.85|
71695254|NCT05559905|142905627|SUPERIORITY||Difference in Least Squares Mean|-0.29||||0.578|TWO_SIDED|90.0|-1.16|0.58|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.58|-1.16|0.578
71695255|NCT05559905|142905628|SUPERIORITY||Difference in Least Squares Mean|-2.69||||0.201|TWO_SIDED|90.0|-6.17|-0.79|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||-0.79|-6.17|0.201
71695256|NCT05559905|142905634|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.736|TWO_SIDED|90.0|-3.65|2.42|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.42|-3.65|0.736
71695257|NCT05559905|142905635|SUPERIORITY||Difference in Least Squares Mean|-1.93||||0.646|TWO_SIDED|90.0|-8.88|5.02|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||5.02|-8.88|0.646
71695258|NCT05559905|142905636|SUPERIORITY||Difference in Least Squares Mean|-0.14||||0.849|TWO_SIDED|90.0|-1.31|1.04|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.04|-1.31|0.849
71695259|NCT05559905|142905637|SUPERIORITY||Difference in Least Squares Mean|-2.09||||0.371|TWO_SIDED|90.0|-5.97|1.78|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.78|-5.97|0.371
71695260|NCT05559905|142905638|SUPERIORITY||Difference in Least Squares Mean|-1.82||||0.36|TWO_SIDED|90.0|-5.11|1.47|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.47|-5.11|0.360
71695261|NCT05559905|142905639|SUPERIORITY||Difference in Least Squares Mean|-0.46||||0.459|TWO_SIDED|90.0|-1.5|0.57|||ANOVA|||Per protocol, only Panel A (prophylaxis) and Panel C (placebo) were included in the model. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.57|-1.50|0.459
71695262|NCT05559905|142905641|SUPERIORITY||Difference in Percent (%)|3.42|||||TWO_SIDED|95.0|-18.28|24.5||||||||24.50|-18.28|
71695263|NCT05559905|142905642|SUPERIORITY||Difference in Percent (%)|2.89|||||TWO_SIDED|95.0|-19.37|25.69||||||||25.69|-19.37|
71695264|NCT05559905|142905643|SUPERIORITY||Difference in Percent (%)|-2.63|||||TWO_SIDED|95.0|-25.07|19.91||||||||19.91|-25.07|
71695265|NCT05559905|142905644|SUPERIORITY||Difference in Percent (%)|-16.18|||||TWO_SIDED|95.0|-36.77|5.64||||||||5.64|-36.77|
71695266|NCT05559905|142905645|SUPERIORITY||Difference in Percent (%)|-2.89|||||TWO_SIDED|95.0|-25.69|19.37||||||||19.37|-25.69|
71695267|NCT05559905|142905646|SUPERIORITY||Difference in Least Squares Mean|-0.69||||0.253|TWO_SIDED|90.0|-1.68|0.31|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.31|-1.68|0.253
71695268|NCT05559905|142905647|SUPERIORITY||Hazard Ratio (HR)|1.72||||0.1708||95.0|0.83|3.57|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||3.57|0.83|0.1708
71695269|NCT05559905|142905648|SUPERIORITY||Difference in Least Squares Mean|-5.93||||0.257|TWO_SIDED|90.0|-14.61|2.75|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean VL-AUC in each group and the differences in mean VL-AUC between MK-4482 and placebo and the corresponding 2-sided 95% CI were computed based on the linear model.||2.75|-14.61|0.257
71695270|NCT05559905|142905649|SUPERIORITY||Difference in Least Squares Mean|-0.58||||0.453|TWO_SIDED|90.0|-1.88|0.71|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean PVL in each group and the differences in mean PVL between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||0.71|-1.88|0.453
71695271|NCT05559905|142905650|SUPERIORITY||Hazard Ratio (HR)|1.06||||0.9121|TWO_SIDED|95.0|0.44|2.51|||Log Rank||Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||2.51|0.44|0.9121
71695272|NCT05559905|142905651|SUPERIORITY||Difference in Least Squares Mean|-1.83||||0.377|TWO_SIDED|90.0|-5.25|1.6|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC in each group and the differences in mean TSS-AUC between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||1.60|-5.25|0.377
71695273|NCT05559905|142905652|SUPERIORITY||Difference in Least Squares Mean|-0.13||||0.958|TWO_SIDED|90.0|-4.28|4.02|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) were included in the model. The TSS-AUC-CFB in each group and the differences in mean TSS-AUC-CFB between MK-4482 and placebo and the corresponding 2- sided 95% CI were computed based on the linear model.||4.02|-4.28|0.958
71695274|NCT05559905|142905653|SUPERIORITY||Difference in Least Squares Mean|-0.62||||0.52|TWO_SIDED|90.0|-2.21|0.98|||ANOVA|||Per protocol, only Panel B (treatment) and Panel C (placebo) are included in the model. For both panels, only the participants with RSV infection were included in the analysis. The mean peak TSS in each group and the differences in mean peak TSS between MK-4482 and placebo and the corresponding 2- sided 95% CI was computed based on the linear model.||0.98|-2.21|0.520
71695275|NCT05559905|142905655|SUPERIORITY||Hazard Ratio (HR)|2.24||||0.0459|TWO_SIDED|95.0|0.99|5.07|||Log Rank|Two-sided p-value based on log-rank test.|Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.|||5.07|0.99|0.0459
71695276|NCT02756910|142905680|OTHER||percentile method|0.5|STANDARD_DEVIATION|1.96|<|0.05|TWO_SIDED|95.0|||||bootstrapping|||||||<0.05
71695277|NCT03829462|142905698|SUPERIORITY||Hazard Ratio (HR)|1.18||||0.5334|TWO_SIDED|95.0|0.7|1.98||The threshold for statistical significance was p=0.05|Log Rank|||To show an increase of median overall survival from 7 to 15 months (30% to 57% rates, respectively), with a HR=0.47 and a power of 80% and alpha=5%, 55 events are required for the 78 patients to be randomized considering 15% additional patients for lost to follow-up.||1.98|0.7|0.5334
71695278|NCT03829462|142905698|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.8894|TWO_SIDED|95.0|0.59|1.82|||Chi-squared|||||1.82|0.59|0.8894
71695279|NCT03829462|142905699|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1104|TWO_SIDED|95.0|0.4|1.11|||Log Rank|The threshold for statistical significance was p=0.05||||1.11|0.4|0.1104
71695280|NCT03829462|142905699|SUPERIORITY||Hazard Ratio (HR)|0.67||||0.1165|TWO_SIDED|95.0|0.4|1.11|||Chi-squared|||||1.11|0.4|0.1165
71695281|NCT03829462|142905700|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2425|TWO_SIDED|95.0|0.26|1.42||The threshold for statistical significance was p=0.05|Log Rank|||||1.42|0.26|0.2425
71695282|NCT03829462|142905700|SUPERIORITY||Hazard Ratio (HR)|0.61||||0.2519|TWO_SIDED|95.0|0.26|1.42|||Chi-squared|||||1.42|0.26|0.2519
71695283|NCT03829462|142905701|SUPERIORITY||Percent difference|46.5||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
71695284|NCT03829462|142905702|SUPERIORITY||Percent difference|7.4||||0.001|TWO_SIDED||||||Fisher Exact|||||||0.001
71695285|NCT04613518|142905709|SUPERIORITY||Mean Difference (Final Values)|3.8|||||TWO_SIDED|95.0|-35.7|43.4||||||||43.4|-35.7|
71695286|NCT02674503|142905719|SUPERIORITY|||||||0.02||||||Linear fixed effect models adjusted for time in months|Regression, Linear|||||||0.02
71943145|NCT01371786|143407965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.92|||||TWO_SIDED|95.0|-21.76|-4.09||No formal statistical testing was conducted. Only descriptive statistics were calculated and presented.|||Difference calculated as Mometasone minus Ciclesonide|No formal null hypothesis was stated or tested.Descriptive statistics only were calculated and presented. The sample size was determined outside of statistical considerations. The sample size of 10 subjects was sufficient to provide approximately 80% power to detect a difference of 25% between the two treatment groups in the percentage of nasal deposition approximately 2 minutes post dose, assuming a two-sided test evaluated at a significance level of 0.05, with a SD of the difference of 23.17%.||-4.09|-21.76|
71943146|NCT02549092|143407970|SUPERIORITY||Least Squares (LS) Mean of Difference|-8.21|STANDARD_ERROR_OF_MEAN|9.91||0.41|TWO_SIDED|95.0|-27.98|11.55||P value is from the mixed model repeated measures (MMRM) with the model: change from Baseline=treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. Unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||11.55|-27.98|0.410
71695287|NCT02674503|142905723|SUPERIORITY|||||||0.13|||||||Regression, Linear|Linear effects model adjusted for time (in months)||||||0.13
71695288|NCT02674503|142905725|SUPERIORITY|||||||0.02|||||||Regression, Linear|Linear mixed effects models adjusted for time (in months)||||||0.02
71695289|NCT01307787|142905753|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.002
71695290|NCT01307787|142905754|SUPERIORITY_OR_OTHER_LEGACY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.47
71695291|NCT01307787|142905755|SUPERIORITY_OR_OTHER_LEGACY|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.24
71695292|NCT01307787|142905756|SUPERIORITY_OR_OTHER_LEGACY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.16
71695293|NCT01307787|142905757|SUPERIORITY_OR_OTHER_LEGACY|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.21
71695294|NCT01307787|142905758|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.07
71695295|NCT01307787|142905759|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.4
71695296|NCT01307787|142905760|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p\< 0.05.||||0.6
71695297|NCT01965327|142905790|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|TWO_SIDED||||||t-test, 2 sided|Missing data were imputed by last observation carried forward.||||||0.027
71695298|NCT01965327|142905791|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0078|TWO_SIDED||||||t-test, 2 sided|||||||0.0078
71695299|NCT01507181|142905792|SUPERIORITY_OR_OTHER|||||||0.32|TWO_SIDED||||||t-test, 2 sided|||||||0.32
71695300|NCT01507181|142905793|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED||||||t-test, 2 sided|||||||0.047
71695301|NCT01507181|142905794|SUPERIORITY_OR_OTHER|||||||0.17||||||Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.|ANCOVA|||||||0.17
71695302|NCT01669434|142905805|SUPERIORITY||Risk Ratio (RR)|0.81||||0.03|TWO_SIDED|95.0|0.67|0.97|||Fisher Exact|||||0.97|0.67|0.03
71695303|NCT01669434|142905806|SUPERIORITY||Risk Ratio (RR)|0.6||||0.44|TWO_SIDED|95.0|0.23|1.6|||Fisher Exact|||||1.60|0.23|0.44
71695304|NCT01669434|142905807|SUPERIORITY||Risk Ratio (RR)|1.2||||1|TWO_SIDED|95.0|0.48|2.99|||Fisher Exact|||||2.99|0.48|1.0
71695305|NCT01669434|142905808|SUPERIORITY||Risk Ratio (RR)|1.01||||1|TWO_SIDED|95.0|0.81|1.26|||Fisher Exact|||||1.26|0.81|1.0
71695306|NCT01669434|142905809|SUPERIORITY||Risk Ratio (RR)|1.95||||0.01|TWO_SIDED|95.0|1.14|3.34|||Fisher Exact|||||3.34|1.14|0.01
71943147|NCT02549092|143407971|SUPERIORITY||LS Mean of Difference|1.57|STANDARD_ERROR_OF_MEAN|2.37||0.509|TWO_SIDED|95.0|-3.16|6.3||The P value is from the MMRM with the model: change from Baseline = treatment, country, visit, Baseline, treatment-by-visit, and Baseline-by-visit. The unstructured variance-covariance structure was used in the MMRM analysis.|mixed model repeated measures|Adjusted for multiplicity using the Hochberg procedure to control the family-wise error rate at a pre-specified significance level (alpha = 0.05).|Difference of LCIG - OMT|||6.30|-3.16|0.509
71943148|NCT02549092|143407972|SUPERIORITY||LS mean difference|-3.81|STANDARD_ERROR_OF_MEAN|3.59||0.291|TWO_SIDED|95.0|-10.96|3.34||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||3.34|-10.96|0.291
71943149|NCT02549092|143407973|SUPERIORITY||LS Mean of Difference|-2.3|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.84|-1.82||Analysis of covariance (ANCOVA) model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-1.82|-2.84|< 0.001
71943150|NCT02549092|143407974|SUPERIORITY||LS mean difference|-2.79|STANDARD_ERROR_OF_MEAN|0.99||0.006|TWO_SIDED|95.0|-4.77|-0.81||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Statistical significance for the 3 key secondary efficacy endpoints (PDQ-8 index score, CGI-C score, and UPDRS Part II) could only be evaluated using the Hochberg procedure for multiplicity control if both primary endpoints had been statistically significant after multiplicity adjustment.||-0.81|-4.77|0.006
71943151|NCT02549092|143407975|SUPERIORITY||LS mean difference|0.08|STANDARD_ERROR_OF_MEAN|0.99||0.933|TWO_SIDED|95.0|-1.89|2.06||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Cardiovascular including falls||2.06|-1.89|0.933
71695307|NCT01669434|142905810|SUPERIORITY||Risk Ratio (RR)|0.49||||0.02|TWO_SIDED|95.0|0.28|0.86|||Fisher Exact|||||0.86|0.28|0.02
71695308|NCT02860988|142905814|OTHER|Two-sided tests versus a margin|Mean Difference (Net)|0.6||||0.29|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.29
71695309|NCT02860988|142905815|OTHER|Two-sided tests versus a margin|Risk Difference (RD)|0.9||||0.88|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.88
71695310|NCT02860988|142905816|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|0.96||||0.89|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.89
71695311|NCT02860988|142905817|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|-4.26||||0.61|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.61
71695312|NCT02860988|142905818|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|3.61||||0.67|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.67
71695313|NCT02860988|142905819|OTHER|Two-sided tests versus a margin.|Risk Difference (RD)|5.23||||0.14|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Logistic|||||||0.14
71695314|NCT02860988|142905820|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.03||||0.81|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.81
71695315|NCT02860988|142905821|OTHER|Two-sided tests versus a margin.|Mean Difference (Net)|0.31||||0.74|TWO_SIDED|||||A priori threshold for statistical significance was set at 0.05.|Regression, Linear|||||||0.74
71695316|NCT00830219|142905840|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|103.53||||||90.0|99.16|108.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.09|99.16|
71695317|NCT00830219|142905841|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.3||||||90.0|97.56|107.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.27|97.56|
71695318|NCT00830219|142905842|NON_INFERIORITY_OR_EQUIVALENCE|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|102.54||||||90.0|97.53|107.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.8|97.53|
71695319|NCT01294423|142905843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.0853|<|0.0001|TWO_SIDED|95.0|-0.52|-0.18||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.18|-0.52|<0.0001
71695320|NCT01294423|142905843|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39|STANDARD_ERROR_OF_MEAN|0.0851|<|0.0001|TWO_SIDED|95.0|-0.56|-0.23||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)||-0.23|-0.56|<0.0001
71695321|NCT01294423|142905844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.4|STANDARD_ERROR_OF_MEAN|2.902|<|0.0001|TWO_SIDED|95.0|-20.1|-8.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-8.7|-20.1|<0.0001
71695322|NCT01294423|142905844|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.5|STANDARD_ERROR_OF_MEAN|2.892|<|0.0001|TWO_SIDED|95.0|-25.2|-13.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-13.8|-25.2|<0.0001
71695323|NCT01294423|142905845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.29|STANDARD_ERROR_OF_MEAN|0.3533||0.0003|TWO_SIDED|95.0|-1.98|-0.59||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.59|-1.98|0.0003
71695324|NCT01294423|142905845|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38|STANDARD_ERROR_OF_MEAN|0.354||0.0001|TWO_SIDED|95.0|-2.08|-0.69||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0||-0.69|-2.08|0.0001
71695325|NCT01868646|142905937|SUPERIORITY|||||||0.0002||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0002
71695326|NCT01868646|142905938|SUPERIORITY|||||||0.0426||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.0426
71695327|NCT01868646|142905939|SUPERIORITY|||||||0.599||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.5990
71695328|NCT01868646|142905940|SUPERIORITY|||||||0.6215||||||"The p-value associated with treatment factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||||||0.6215
71695329|NCT01868646|142905941|SUPERIORITY|||||||0.6155||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.6155
71695330|NCT01868646|142905941|SUPERIORITY|||||||0.7507||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.7507
71695331|NCT01868646|142905941|SUPERIORITY|||||||0.4195||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.4195
71695332|NCT01868646|142905941|SUPERIORITY|||||||0.3609||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.||||0.3609
71695333|NCT01868646|142905942|SUPERIORITY|||||||0.0605|||||||t-test, 2 sided|||||||0.0605
71695334|NCT01868646|142905943|SUPERIORITY|||||||0.0726|||||||t-test, 2 sided|||||||0.0726
71695335|NCT01868646|142905944|SUPERIORITY|||||||0.3108|||||||Fisher Exact|||||||0.3108
71695336|NCT01868646|142905945|SUPERIORITY|||||||0.2934|||||||t-test, 2 sided|||||||0.2934
71695337|NCT01868646|142905946|SUPERIORITY|||||||0.341|||||||t-test, 2 sided|||||||0.3410
71695338|NCT01868646|142905947|SUPERIORITY|||||||0.1577|||||||t-test, 2 sided|||Satisfaction||||0.1577
71695339|NCT01868646|142905947|SUPERIORITY|||||||0.5262|||||||t-test, 2 sided|||Hyperglycemia||||0.5262
71695340|NCT01868646|142905947|SUPERIORITY|||||||0.7417|||||||t-test, 2 sided|||Hypoglycemia||||0.7417
71695341|NCT03191799|142905978|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71695342|NCT03191799|142905978|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71695343|NCT03191799|142905978|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71695344|NCT03191799|142905978|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71695345|NCT03191799|142905978|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71695346|NCT03191799|142905980|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71695347|NCT03191799|142905980|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71695348|NCT03191799|142905980|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71695349|NCT03191799|142905980|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71695350|NCT03191799|142905980|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71695351|NCT03191799|142905991|SUPERIORITY|||||||0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||0.0001
71695352|NCT03191799|142905991|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71695353|NCT03191799|142905991|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71695354|NCT03191799|142905991|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71695355|NCT03191799|142905991|SUPERIORITY|||||||0.0004|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||0.0004
71695356|NCT03191799|142905993|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71695357|NCT03191799|142905993|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71695358|NCT03191799|142905993|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71695359|NCT03191799|142905993|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71695360|NCT03191799|142905993|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71695361|NCT03191799|142906003|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71695362|NCT03191799|142906003|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71695363|NCT03191799|142906003|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71695364|NCT03191799|142906003|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71943152|NCT02549092|143407975|SUPERIORITY||LS mean difference|1.05|STANDARD_ERROR_OF_MEAN|2.35||0.655|TWO_SIDED|95.0|-3.63|5.74||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sleep/fatigue||5.74|-3.63|0.655
71943153|NCT02549092|143407975|SUPERIORITY||LS mean difference|-1.85|STANDARD_ERROR_OF_MEAN|3.67||0.616|TWO_SIDED|95.0|-9.18|5.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Mood/cognition||5.48|-9.18|0.616
71695365|NCT03191799|142906003|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71695366|NCT03191799|142906004|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 3 vs. Baseline||||<0.0001
71695367|NCT03191799|142906004|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 6 vs. Baseline||||<0.0001
71695368|NCT03191799|142906004|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 12 vs. Baseline||||<0.0001
71695369|NCT03191799|142906004|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Month 18 vs. Baseline||||<0.0001
71695370|NCT03191799|142906004|SUPERIORITY||||||<|0.0001|||||||Paired t-test|||Early Terminatinon/Study Completion vs. Baseline||||<0.0001
71943154|NCT02549092|143407975|SUPERIORITY||LS mean difference|0.39|STANDARD_ERROR_OF_MEAN|0.84||0.645|TWO_SIDED|95.0|-1.3|2.08||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Perceptual problems/hallucinations||2.08|-1.30|0.645
71943155|NCT02549092|143407975|SUPERIORITY||LS mean difference|-0.94|STANDARD_ERROR_OF_MEAN|2.04||0.645|TWO_SIDED|95.0|-5.03|3.14||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Attention/memory||3.14|-5.03|0.645
71943156|NCT02549092|143407975|SUPERIORITY||LS mean difference|-2.58|STANDARD_ERROR_OF_MEAN|1.34||0.058|TWO_SIDED|95.0|-5.25|0.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Gastrointestinal tract||0.09|-5.25|0.058
71943157|NCT02549092|143407975|SUPERIORITY||LS mean difference|-1.18|STANDARD_ERROR_OF_MEAN|2.17||0.588|TWO_SIDED|95.0|-5.52|3.15||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Urinary||3.15|-5.52|0.588
71943158|NCT02549092|143407975|SUPERIORITY||LS mean difference|-0.78|STANDARD_ERROR_OF_MEAN|1.05||0.464|TWO_SIDED|95.0|-2.88|1.33||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Sexual function||1.33|-2.88|0.464
71943159|NCT02549092|143407975|SUPERIORITY||LS mean difference|-1.29|STANDARD_ERROR_OF_MEAN|1.76||0.468|TWO_SIDED|95.0|-4.8|2.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|Repeated measures model||Difference of LCIG - OMT|Miscellaneous||2.23|-4.80|0.468
71943160|NCT02549092|143407976|SUPERIORITY||LS Mean of Difference|-0.58|STANDARD_ERROR_OF_MEAN|1.26||0.643|TWO_SIDED|95.0|-3.09|1.92||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Motor symptoms at night||1.92|-3.09|0.643
71943161|NCT02549092|143407976|SUPERIORITY||LS Mean of Difference|0.24|STANDARD_ERROR_OF_MEAN|0.82||0.769|TWO_SIDED|95.0|-1.39|1.87||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|PD symptoms at night||1.87|-1.39|0.769
71943162|NCT02549092|143407976|SUPERIORITY||LS Mean of Difference|1.99|STANDARD_ERROR_OF_MEAN|0.84||0.02|TWO_SIDED|95.0|0.32|3.66||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Disturbed sleep||3.66|0.32|0.020
71943163|NCT02549092|143407977|SUPERIORITY||LS Mean of Difference|0.19|STANDARD_ERROR_OF_MEAN|0.46||0.672|TWO_SIDED|95.0|-0.72|1.1||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part I score||1.10|-0.72|0.672
71943164|NCT02549092|143407977|SUPERIORITY||LS Mean of Difference|-2.22|STANDARD_ERROR_OF_MEAN|2.13||0.302|TWO_SIDED|95.0|-6.47|2.04||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part III score||2.04|-6.47|0.302
71943165|NCT02549092|143407977|SUPERIORITY||LS Mean of Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.61||0.007|TWO_SIDED|95.0|-2.91|-0.48||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Part IV score||-0.48|-2.91|0.007
71943166|NCT02549092|143407978|SUPERIORITY||LS Mean of Difference|-1.54|STANDARD_ERROR_OF_MEAN|1.5||0.307|TWO_SIDED|95.0|-4.52|1.44||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||1.44|-4.52|0.307
71943167|NCT02549092|143407979|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.46||0.868|TWO_SIDED|95.0|-0.99|0.84||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|||0.84|-0.99|0.868
71943168|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|-1.14|STANDARD_ERROR_OF_MEAN|3.28||0.728|TWO_SIDED|95.0|-7.68|5.39||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Total score||5.39|-7.68|0.728
71943169|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|-0.08|STANDARD_ERROR_OF_MEAN|0.71||0.916|TWO_SIDED|95.0|-1.5|1.35||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Musculoskeletal pain score||1.35|-1.50|0.916
71943170|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|0.07|STANDARD_ERROR_OF_MEAN|0.68||0.919|TWO_SIDED|95.0|-1.28|1.42||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Chronic pain score||1.42|-1.28|0.919
71943171|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|0.63|STANDARD_ERROR_OF_MEAN|1.53||0.68|TWO_SIDED|95.0|-2.42|3.68||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Fluctuation related pain score||3.68|-2.42|0.680
71943172|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|-0.37|STANDARD_ERROR_OF_MEAN|1.24||0.767|TWO_SIDED|95.0|-2.83|2.09||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Nocturnal pain score||2.09|-2.83|0.767
71943173|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.51||0.804|TWO_SIDED|95.0|-1.15|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Orofacial pain score||0.90|-1.15|0.804
71943174|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|-1.81|STANDARD_ERROR_OF_MEAN|0.79||0.025|TWO_SIDED|95.0|-3.38|-0.23||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Discoloration and edema score||-0.23|-3.38|0.025
71943175|NCT02549092|143407980|SUPERIORITY||LS Mean of Difference|-0.04|STANDARD_ERROR_OF_MEAN|0.47||0.93|TWO_SIDED|95.0|-0.99|0.9||The repeated measures model: change = treatment, country, visit, baseline, treatment \* visit, baseline \* visit. The unstructured variance-covariance structure is used.|repeated measures model||Difference of LCIG - OMT|Radicular pain score||0.90|-0.99|0.930
71943176|NCT02549092|143407981|SUPERIORITY||LS Mean of Difference|-2.4|STANDARD_ERROR_OF_MEAN|0.26|<|0.001|TWO_SIDED|95.0|-2.89|-1.87||ANCOVA model: FINAL = treatment, country.|ANCOVA||Difference of LCIG - OMT|||-1.87|-2.89|< 0.001
71943177|NCT02511782|143407982|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71943178|NCT02511782|143407983|SUPERIORITY_OR_OTHER||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71943179|NCT01376167|143407993|SUPERIORITY||Hazard Ratio (HR)|0.299|||<|0.001|TWO_SIDED|95.0|0.222|0.404||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.404|0.222|<0.001
71943180|NCT01376167|143407993|SUPERIORITY||Hazard Ratio (HR)|0.262|||<|0.001|TWO_SIDED|95.0|0.178|0.387||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.387|0.178|<0.001
71695371|NCT02337062|142906008|SUPERIORITY||||||<|0.001||||||The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson's χ2 test.||||<0.001
71695372|NCT02337062|142906009|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71695373|NCT02337062|142906010|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71695374|NCT02337062|142906011|SUPERIORITY|||||||0.002|||||||Chi-squared|||||||0.002
71695375|NCT02337062|142906012|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71695376|NCT02337062|142906013|SUPERIORITY||||||<|0.001|||||||Log Rank|||||||<0.001
71695377|NCT02631941|142906047|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|100.64|||<|0.001|TWO_SIDED|90.0|95.82|105.69|||Mixed Models Analysis|||||105.69|95.82|<0.001
71695378|NCT02631941|142906047|EQUIVALENCE|For budesonide AUC0-last, the 90% Cls for Z7200 compared with Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80% - 125.00%).|Adjusted geometric means ratio|102.11|||<|0.001|TWO_SIDED|90.0|95.55|109.13|||Mixed Models Analysis|||||109.13|95.55|<0.001
71695379|NCT02631941|142906048|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|87.96||||0.002|TWO_SIDED|90.0|83.31|92.86|||Mixed Models Analysis|||||92.86|83.31|0.002
71695380|NCT02631941|142906048|EQUIVALENCE|For Formoterol AUC0-last, the 90% Cls for Z7200 compared to Symbicort without and with charcoal lie entirely within the standard bioequivalence acceptance limits of (80.00%, 125.00%).|Adjusted geometric means ratio|91.17||||0.005|TWO_SIDED|90.0|83.94|99.04|||Mixed Models Analysis|||||99.04|83.94|0.005
71695381|NCT02631941|142906049|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|157.86||||1|TWO_SIDED|90.0|144.12|172.91|||Mixed Models Analysis|||||172.91|144.12|1.00
71695382|NCT02631941|142906049|EQUIVALENCE|For Budesonide Cmax, the 90% Cls for Z7200 compared with Symbicort without and with charcoal do not lie entirely within the wider bioequivalence acceptance limits of ( 73.74%, 135.62%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|166.81||||1|TWO_SIDED|90.0|148.35|187.57|||Mixed Models Analysis|||||187.57|148.35|1.00
71695383|NCT02631941|142906050|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|85.22||||0.012|TWO_SIDED|90.0|79.66|91.17|||Mixed Models Analysis|||||91.17|79.66|0.012
71695384|NCT02631941|142906050|EQUIVALENCE|For Formoterol Cmax, the 90% Cl for Z7200 compared to Symbicort without and with charcoal lie entirely within the wider bioequivalence acceptance limits of (77.65%, 128.79%) and standard bioequivalence acceptance limits of (80.00%, 125.00%), respectively.|Adjusted geometric means ratio|87.74||||0.02|TWO_SIDED|90.0|81.48|94.47|||Mixed Models Analysis|||||94.47|81.48|0.020
71695385|NCT02858401|142906066|OTHER|||||||0.1498|||||||Wilcoxon rank sum test|||||||0.1498
71695386|NCT02858401|142906066|OTHER|||||||0.064|||||||Wilcoxon rank sum test|||||||0.0640
71695387|NCT02858401|142906066|OTHER|||||||0.2807|||||||Wilcoxon rank sum test|||||||0.2807
71695388|NCT02858401|142906066|OTHER|||||||0.1228|||||||Wilcoxon rank sum test|||||||0.1228
71695389|NCT02858401|142906066|OTHER|||||||0.0289|||||||Wilcoxon rank sum test|||||||0.0289
71695390|NCT02858401|142906066|OTHER|||||||0.5895|||||||Wilcoxon rank sum test|||||||0.5895
71695391|NCT02858401|142906067|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695392|NCT02858401|142906067|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695393|NCT02858401|142906067|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695394|NCT02858401|142906068|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71695395|NCT02858401|142906068|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71695396|NCT02858401|142906068|OTHER|||||||0.8288|||||||Wilcoxon rank sum test|||||||0.8288
71695397|NCT02858401|142906068|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71695398|NCT02858401|142906068|OTHER|||||||0.6056|||||||Wilcoxon rank sum test|||||||0.6056
71695399|NCT02858401|142906068|OTHER|||||||0.5557|||||||Wilcoxon rank sum test|||||||0.5557
71695400|NCT02858401|142906069|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695401|NCT02858401|142906069|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695402|NCT02858401|142906069|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695403|NCT02858401|142906070|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695404|NCT02858401|142906070|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695405|NCT02858401|142906070|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
71695406|NCT02858401|142906070|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695407|NCT02858401|142906070|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695408|NCT02858401|142906070|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695409|NCT02858401|142906071|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695410|NCT02858401|142906071|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695411|NCT02858401|142906071|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
71695412|NCT02858401|142906072|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695413|NCT02858401|142906072|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695414|NCT02858401|142906072|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71695415|NCT02858401|142906072|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695416|NCT02858401|142906072|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695417|NCT02858401|142906072|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695418|NCT02858401|142906073|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71943181|NCT01376167|143407993|SUPERIORITY||Odds Ratio (OR)|0.241|||<|0.001|TWO_SIDED|95.0|0.152|0.382||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.382|0.152|<0.001
71943182|NCT01376167|143407993|SUPERIORITY||Odds Ratio (OR)|0.198|||<|0.001|TWO_SIDED|95.0|0.117|0.335||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios \< 1 suggested a smaller chance of recurrence compared to CQ Only.|||0.335|0.117|<0.001
71943183|NCT01376167|143407994|SUPERIORITY||Hazard Ratio (HR)|0.271|||<|0.001|TWO_SIDED|95.0|0.195|0.376||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.376|0.195|<0.001
71943184|NCT01376167|143407994|SUPERIORITY||Hazard Ratio (HR)|0.255|||<|0.001|TWO_SIDED|95.0|0.167|0.39||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio\<1 indicated a lower chance of relapse compared to CQ only.|||0.390|0.167|<0.001
71943185|NCT02158494|143408034|SUPERIORITY|||||||0.41|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 2 weeks||||0.41
71943186|NCT02158494|143408034|SUPERIORITY|||||||0.47|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 14 weeks||||0.47
71943187|NCT02158494|143408034|SUPERIORITY|||||||0.99|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 26 weeks||||0.99
71695419|NCT02858401|142906073|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71943188|NCT02008565|143408063|SUPERIORITY|||||||0.092||||||significance assessed at type 1 error alpha=0.05|Mixed Models Analysis|The models were adjusted for baseline Irritable Bowel Syndrome (IBS) status and clinical site.||||||0.092
71943189|NCT03435081|143408093|SUPERIORITY||Odds Ratio (OR)|4.6|||<|0.001|TWO_SIDED|95.0|2.31|9.15|||Regression, Logistic|||||9.15|2.31|<0.001
71695420|NCT02858401|142906073|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71943190|NCT03435081|143408094|SUPERIORITY||Odds Ratio (OR)|2.51||||0.033|TWO_SIDED|95.0|1.08|5.83|||Regression, Logistic|||||5.83|1.08|0.033
71943191|NCT03435081|143408094|SUPERIORITY||Odds Ratio (OR)|5.29|||<|0.001|TWO_SIDED|95.0|2.4|11.68|||Regression, Logistic|||||11.68|2.40|<0.001
71943192|NCT03435081|143408095|SUPERIORITY||Odds Ratio (OR)|1.71||||0.167|TWO_SIDED|95.0|0.8|3.63|||Regression, Logistic|||||3.63|0.80|0.167
71695421|NCT02858401|142906074|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695422|NCT02858401|142906074|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695423|NCT02858401|142906074|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695424|NCT02858401|142906075|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695425|NCT02858401|142906075|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695426|NCT02858401|142906075|OTHER|||||||0.1556|||||||Wilcoxon rank sum test|||||||0.1556
71695427|NCT02858401|142906075|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695428|NCT02858401|142906075|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71943193|NCT03435081|143408096|SUPERIORITY||Odds Ratio (OR)|2.23||||0.131|TWO_SIDED|95.0|0.79|6.31|||Regression, Logistic|||||6.31|0.79|0.131
71943194|NCT03435081|143408096|SUPERIORITY||Odds Ratio (OR)|6.73|||<|0.001|TWO_SIDED|95.0|2.63|17.19|||Regression, Logistic|||||17.19|2.63|<0.001
71943195|NCT03435081|143408097|SUPERIORITY||Mean Difference (Final Values)|-12.59|STANDARD_ERROR_OF_MEAN|7.079||0.077|TWO_SIDED|95.0|-26.54|1.36|||Mixed Models Analysis|||||1.36|-26.54|0.077
71943196|NCT03435081|143408097|SUPERIORITY||Mean Difference (Final Values)|-20.3|STANDARD_ERROR_OF_MEAN|6.875||0.004|TWO_SIDED|95.0|-33.85|-6.75|||Mixed Models Analysis|||||-6.75|-33.85|0.004
71943197|NCT03435081|143408098|SUPERIORITY||Odds Ratio (OR)|1.24||||0.733|TWO_SIDED|95.0|0.36|4.36|||Regression, Logistic|||||4.36|0.36|0.733
71943198|NCT03435081|143408098|SUPERIORITY||Odds Ratio (OR)|5.42||||0.002|TWO_SIDED|95.0|1.93|15.22|||Regression, Logistic|||||15.22|1.93|0.002
71943199|NCT03435081|143408099|SUPERIORITY||Odds Ratio (OR)|3.08||||0.012|TWO_SIDED|95.0|1.29|7.36|||Regression, Logistic|||||7.36|1.29|0.012
71943200|NCT03435081|143408099|SUPERIORITY||Odds Ratio (OR)|5.32|||<|0.001|TWO_SIDED|95.0|2.31|12.28|||Regression, Logistic|||||12.28|2.31|<0.001
71943201|NCT03435081|143408100|SUPERIORITY||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.273||0.433|TWO_SIDED|95.0|-0.75|0.32|||Mixed Models Analysis|||||0.32|-0.75|0.433
71943202|NCT03435081|143408100|SUPERIORITY||Mean Difference (Final Values)|-0.59|STANDARD_ERROR_OF_MEAN|0.269||0.029|TWO_SIDED|95.0|-1.12|-0.06|||Mixed Models Analysis|||||-0.06|-1.12|0.029
71943203|NCT03435081|143408101|SUPERIORITY||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.441||0.012|TWO_SIDED|95.0|-1.99|-0.25|||Mixed Models Analysis|||||-0.25|-1.99|0.012
71943204|NCT03435081|143408101|SUPERIORITY||Mean Difference (Final Values)|-1.36|STANDARD_ERROR_OF_MEAN|0.433||0.002|TWO_SIDED|95.0|-2.22|-0.51|||Mixed Models Analysis|||||-0.51|-2.22|0.002
71943205|NCT03435081|143408102|SUPERIORITY||Odds Ratio (OR)|1.69||||0.105|TWO_SIDED|95.0|0.9|3.2|||Regression, Logistic|||||3.20|0.90|0.105
71943206|NCT03435081|143408102|SUPERIORITY||Odds Ratio (OR)|3.67|||<|0.001|TWO_SIDED|95.0|2.02|6.68|||Regression, Logistic|||||6.68|2.02|<0.001
71943207|NCT03435081|143408103|SUPERIORITY||Odds Ratio (OR)|3.81||||0.144|TWO_SIDED|95.0|0.63|22.85|||Regression, Logistic|||||22.85|0.63|0.144
71943208|NCT03435081|143408103|SUPERIORITY||Odds Ratio (OR)|3.1||||0.227|TWO_SIDED|95.0|0.5|19.4|||Regression, Logistic|||||19.40|0.50|0.227
71943209|NCT03435081|143408104|SUPERIORITY||Mean Difference (Final Values)|-3.94|STANDARD_ERROR_OF_MEAN|3.921||0.316|TWO_SIDED|95.0|-11.67|3.79|||Mixed Models Analysis|||||3.79|-11.67|0.316
71943210|NCT03435081|143408104|SUPERIORITY||Mean Difference (Final Values)|-11.81|STANDARD_ERROR_OF_MEAN|3.758||0.002|TWO_SIDED|95.0|-19.23|-4.4|||Mixed Models Analysis|||||-4.40|-19.23|0.002
71943211|NCT03435081|143408105|SUPERIORITY||Odds Ratio (OR)|1.39||||0.683|TWO_SIDED|95.0|0.29|6.78|||Regression, Logistic|||||6.78|0.29|0.683
71943212|NCT03435081|143408105|SUPERIORITY||Odds Ratio (OR)|2.25||||0.277|TWO_SIDED|95.0|0.52|9.68|||Regression, Logistic|||||9.68|0.52|0.277
71943213|NCT03435081|143408106|SUPERIORITY||Mean Difference (Final Values)|-6.02|STANDARD_ERROR_OF_MEAN|2.996||0.046|TWO_SIDED|95.0|-11.93|-0.12|||Mixed Models Analysis|||||-0.12|-11.93|0.046
71943214|NCT03435081|143408106|SUPERIORITY||Mean Difference (Final Values)|-7.72|STANDARD_ERROR_OF_MEAN|2.911||0.009|TWO_SIDED|95.0|-13.46|-1.98|||Mixed Models Analysis|||||-1.98|-13.46|0.009
71943215|NCT03435081|143408107|SUPERIORITY|||||||0.598|||||||Fisher Exact|||||||0.598
71943216|NCT03435081|143408107|SUPERIORITY|||||||0.785|||||||Fisher Exact|||||||0.785
71943217|NCT03435081|143408108|SUPERIORITY||Mean Difference (Final Values)|-12.27|STANDARD_ERROR_OF_MEAN|6.562||0.063|TWO_SIDED|95.0|-25.21|0.66|||Mixed Models Analysis|||||0.66|-25.21|0.063
71943218|NCT03435081|143408108|SUPERIORITY||Mean Difference (Final Values)|-21.85|STANDARD_ERROR_OF_MEAN|6.437|<|0.001|TWO_SIDED|95.0|-34.54|-9.17|||Mixed Models Analysis|||||-9.17|-34.54|<0.001
71695429|NCT02858401|142906075|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695430|NCT02858401|142906076|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695431|NCT02858401|142906076|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695432|NCT02858401|142906076|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695433|NCT02858401|142906077|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71943219|NCT03435081|143408109|SUPERIORITY||Mean Difference (Final Values)|-1.9|STANDARD_ERROR_OF_MEAN|1.536||0.217|TWO_SIDED|95.0|-4.93|1.12|||Mixed Models Analysis|||||1.12|-4.93|0.217
71943220|NCT03435081|143408109|SUPERIORITY||Mean Difference (Final Values)|-4.77|STANDARD_ERROR_OF_MEAN|1.487||0.002|TWO_SIDED|95.0|-7.7|-1.84|||Mixed Models Analysis|||||-1.84|-7.70|0.002
71943221|NCT03435081|143408110|SUPERIORITY||Mean Difference (Final Values)|-0.25|STANDARD_ERROR_OF_MEAN|0.178||0.155|TWO_SIDED|95.0|-0.6|0.1|||Mixed Models Analysis|||||0.10|-0.60|0.155
71943222|NCT03435081|143408110|SUPERIORITY||Mean Difference (Final Values)|-0.42|STANDARD_ERROR_OF_MEAN|0.174||0.017|TWO_SIDED|95.0|-0.76|-0.07|||Mixed Models Analysis|||||-0.07|-0.76|0.017
71943223|NCT03435081|143408111|SUPERIORITY||Mean Difference (Final Values)|0.53|STANDARD_ERROR_OF_MEAN|0.565||0.345|TWO_SIDED|95.0|-0.58|1.65|||Mixed Models Analysis|||Anxiety||1.65|-0.58|0.345
71943224|NCT03435081|143408111|SUPERIORITY||Mean Difference (Final Values)|-0.52|STANDARD_ERROR_OF_MEAN|0.543||0.336|TWO_SIDED|95.0|-1.59|0.55|||Mixed Models Analysis|||Anxiety||0.55|-1.59|0.336
71943225|NCT03435081|143408111|SUPERIORITY||Mean Difference (Final Values)|0.43|STANDARD_ERROR_OF_MEAN|0.465||0.353|TWO_SIDED|95.0|-0.48|1.35|||Mixed Models Analysis|||Depression||1.35|-0.48|0.353
71943226|NCT03435081|143408111|SUPERIORITY||Mean Difference (Final Values)|-0.43|STANDARD_ERROR_OF_MEAN|0.446||0.34|TWO_SIDED|95.0|-1.31|0.45|||Mixed Models Analysis|||Depression||0.45|-1.31|0.340
71943227|NCT03435081|143408112|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|1.228||0.224|TWO_SIDED|95.0|-3.92|0.92|||Mixed Models Analysis|||||0.92|-3.92|0.224
71943228|NCT03435081|143408112|SUPERIORITY||Mean Difference (Final Values)|-3.5|STANDARD_ERROR_OF_MEAN|1.184||0.004|TWO_SIDED|95.0|-5.83|-1.16|||Mixed Models Analysis|||||-1.16|-5.83|0.004
71943229|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-3.36|STANDARD_ERROR_OF_MEAN|5.956||0.575|TWO_SIDED|95.0|-15.3|8.57|||Mixed Models Analysis|||Absenteeism Change from Baseline||8.57|-15.30|0.575
71943230|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-1.07|STANDARD_ERROR_OF_MEAN|5.664||0.851|TWO_SIDED|95.0|-12.43|10.3|||Mixed Models Analysis|||Absenteeism Change from Baseline||10.30|-12.43|0.851
71943231|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-11.75|STANDARD_ERROR_OF_MEAN|5.212||0.026|TWO_SIDED|95.0|-22.05|-1.45|||Mixed Models Analysis|||Presenteeism Change from Baseline||-1.45|-22.05|0.026
71943232|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-15.9|STANDARD_ERROR_OF_MEAN|5.056||0.002|TWO_SIDED|95.0|-25.89|-5.91|||Mixed Models Analysis|||Presenteeism Change from Baseline||-5.91|-25.89|0.002
71695434|NCT02858401|142906077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695435|NCT02858401|142906077|OTHER|||||||0.4278|||||||Wilcoxon rank sum test|||||||0.4278
71695436|NCT02858401|142906077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695437|NCT02858401|142906077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695438|NCT02858401|142906077|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695439|NCT02858401|142906078|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695440|NCT02858401|142906078|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
71695441|NCT02858401|142906078|OTHER|||||||0.1869|||||||Wilcoxon rank sum test|||||||0.1869
71943233|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-12.85|STANDARD_ERROR_OF_MEAN|6.237||0.041|TWO_SIDED|95.0|-25.18|-0.51|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-0.51|-25.18|0.041
71695442|NCT02858401|142906078|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695443|NCT02858401|142906078|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695444|NCT02858401|142906079|OTHER|||||||0.3613|||||||Wilcoxon rank sum test|||||||0.3613
71695445|NCT02858401|142906079|OTHER|||||||0.4237|||||||Wilcoxon rank sum test|||||||0.4237
71695446|NCT02858401|142906079|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
71695447|NCT02858401|142906080|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71695448|NCT02858401|142906080|OTHER|||||||0.3971|||||||Wilcoxon rank sum test|||||||0.3971
71695449|NCT02858401|142906080|OTHER|||||||0.1301|||||||Wilcoxon rank sum test|||||||0.1301
71943234|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-16.27|STANDARD_ERROR_OF_MEAN|6.034||0.008|TWO_SIDED|95.0|-28.2|-4.34|||Mixed Models Analysis|||Overall Work Impairment Change from Baseline||-4.34|-28.20|0.008
71943235|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-9.64|STANDARD_ERROR_OF_MEAN|4.219||0.023|TWO_SIDED|95.0|-17.95|-1.32|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-1.32|-17.95|0.023
71695450|NCT02858401|142906080|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71695451|NCT02858401|142906080|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71695452|NCT02858401|142906080|OTHER|||||||0.3456|||||||Wilcoxon rank sum test|||||||0.3456
71695453|NCT02858401|142906081|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695454|NCT02858401|142906081|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71695455|NCT02858401|142906081|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
71695456|NCT02858401|142906082|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695457|NCT02858401|142906082|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695458|NCT02858401|142906082|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71695459|NCT02858401|142906082|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695460|NCT02858401|142906082|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695461|NCT02858401|142906082|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695462|NCT02858401|142906083|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695463|NCT02858401|142906083|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695464|NCT02858401|142906083|OTHER|||||||0.2763|||||||Wilcoxon rank sum test|||||||0.2763
71695465|NCT02858401|142906083|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695466|NCT02858401|142906083|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695467|NCT02858401|142906084|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695468|NCT02858401|142906084|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695469|NCT02858401|142906084|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695470|NCT02858401|142906085|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695471|NCT02858401|142906085|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695472|NCT02858401|142906085|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71695473|NCT02858401|142906085|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695474|NCT02858401|142906085|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695475|NCT02858401|142906085|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695476|NCT02858401|142906086|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695477|NCT02858401|142906086|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695478|NCT02858401|142906086|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695479|NCT02858401|142906087|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695480|NCT02858401|142906087|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
71695481|NCT02858401|142906087|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
71695482|NCT02858401|142906087|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695483|NCT02858401|142906087|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695484|NCT02858401|142906087|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695485|NCT02858401|142906088|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695486|NCT02858401|142906088|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695487|NCT02858401|142906088|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695488|NCT02858401|142906089|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71695489|NCT02858401|142906089|OTHER|||||||0.3755|||||||Wilcoxon rank sum test|||||||0.3755
71695490|NCT02858401|142906089|OTHER|||||||0.4577|||||||Wilcoxon rank sum test|||||||0.4577
71695491|NCT02858401|142906089|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71695492|NCT02858401|142906089|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71695493|NCT02858401|142906089|OTHER|||||||0.3237|||||||Wilcoxon rank sum test|||||||0.3237
71695494|NCT02858401|142906090|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695495|NCT02858401|142906090|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71695496|NCT02858401|142906090|OTHER|||||||0.7526|||||||Wilcoxon rank sum test|||||||0.7526
71695497|NCT02858401|142906091|OTHER|||||||0.5546|||||||Wilcoxon rank sum test|||||||0.5546
71943236|NCT03435081|143408113|SUPERIORITY||Mean Difference (Final Values)|-13.29|STANDARD_ERROR_OF_MEAN|4.115||0.001|TWO_SIDED|95.0|-21.4|-5.17|||Mixed Models Analysis|||Activity Impairment Change from Baseline||-5.17|-21.40|0.001
71695498|NCT02858401|142906091|OTHER|||||||0.6937|||||||Wilcoxon rank sum test|||||||0.6937
71695499|NCT02858401|142906091|OTHER|||||||0.8207|||||||Wilcoxon rank sum test|||||||0.8207
71695500|NCT02858401|142906091|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695501|NCT02858401|142906091|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695502|NCT02858401|142906091|OTHER|||||||0.7878|||||||Wilcoxon rank sum test|||||||0.7878
71695503|NCT02858401|142906092|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695504|NCT02858401|142906092|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695505|NCT02858401|142906092|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695506|NCT02858401|142906093|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71943237|NCT03435081|143408114|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.026||0.482|TWO_SIDED|95.0|-0.03|0.07|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.07|-0.03|0.482
71943238|NCT03435081|143408114|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.026||0.043|TWO_SIDED|95.0|0.0|0.1|||Mixed Models Analysis|||Health State Index Score (US algorithm)||0.10|0.00|0.043
71695507|NCT02858401|142906093|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695508|NCT02858401|142906093|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695509|NCT02858401|142906093|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695510|NCT02858401|142906093|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||||||1.0000
71695511|NCT02858401|142906093|OTHER|||||||0.1949|||||||Wilcoxon rank sum test|||||||0.1949
71695512|NCT02858401|142906094|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695513|NCT02858401|142906094|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
71695514|NCT02858401|142906094|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
71695515|NCT02858401|142906094|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71943239|NCT03435081|143408114|SUPERIORITY||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.037||0.656|TWO_SIDED|95.0|-0.06|0.09|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.09|-0.06|0.656
71695516|NCT02858401|142906094|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695517|NCT02858401|142906095|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695518|NCT02858401|142906095|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695519|NCT02858401|142906095|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695520|NCT02858401|142906096|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695521|NCT02858401|142906096|OTHER|||||||0.5896|||||||Wilcoxon rank sum test|||||||0.5896
71695522|NCT02858401|142906096|OTHER|||||||0.1784|||||||Wilcoxon rank sum test|||||||0.1784
71695523|NCT02858401|142906096|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695524|NCT02858401|142906096|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695525|NCT02858401|142906096|OTHER|||||||0.5383|||||||Wilcoxon rank sum test|||||||0.5383
71695526|NCT02858401|142906097|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695527|NCT02858401|142906097|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695528|NCT02858401|142906097|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695529|NCT02858401|142906098|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695530|NCT02858401|142906098|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695531|NCT02858401|142906098|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695532|NCT02858401|142906099|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71695533|NCT02858401|142906099|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71695534|NCT02858401|142906100|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695535|NCT02858401|142906100|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695536|NCT02858401|142906100|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695537|NCT02858401|142906101|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71695538|NCT02858401|142906101|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71695539|NCT02858401|142906101|OTHER|||||||0.5993|||||||Wilcoxon rank sum test|||||||0.5993
71695540|NCT02858401|142906102|OTHER|||||||0.8504|||||||Wilcoxon rank sum test|||||||0.8504
71695541|NCT02858401|142906102|OTHER|||||||0.5716|||||||Wilcoxon rank sum test|||||||0.5716
71695542|NCT02858401|142906102|OTHER|||||||0.6908|||||||Wilcoxon rank sum test|||||||0.6908
71695543|NCT02858401|142906102|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695544|NCT02858401|142906102|OTHER|||||||0.5186|||||||Wilcoxon rank sum test|||||||0.5186
71695545|NCT02858401|142906103|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695546|NCT02858401|142906103|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695547|NCT02858401|142906103|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695548|NCT02858401|142906104|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695549|NCT02858401|142906104|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695550|NCT02858401|142906104|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695551|NCT02858401|142906105|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71695552|NCT02858401|142906105|OTHER|||||||0.3074|||||||Wilcoxon rank sum test|||||||0.3074
71695553|NCT02858401|142906106|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695554|NCT02858401|142906106|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695555|NCT02858401|142906106|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695556|NCT02858401|142906107|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695557|NCT02858401|142906107|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695558|NCT02858401|142906107|OTHER|||||||1|||||||Wilcoxon rank sum test|||||||1.0000
71695559|NCT02858401|142906108|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71695560|NCT02858401|142906108|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71695561|NCT02858401|142906108|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
71943240|NCT03435081|143408114|SUPERIORITY||Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.036||0.057|TWO_SIDED|95.0|0.0|0.14|||Mixed Models Analysis|||Health State Index Score (UK algorithm)||0.14|-0.00|0.057
71943241|NCT03435081|143408115|SUPERIORITY||Mean Difference (Final Values)|-1.33|STANDARD_ERROR_OF_MEAN|2.597||0.609|TWO_SIDED|95.0|-6.45|3.79|||Mixed Models Analysis|||||3.79|-6.45|0.609
71943242|NCT03435081|143408115|SUPERIORITY||Mean Difference (Final Values)|3.48|STANDARD_ERROR_OF_MEAN|2.503||0.166|TWO_SIDED|95.0|-1.46|8.41|||Mixed Models Analysis|||||8.41|-1.46|0.166
71943243|NCT03435081|143408116|SUPERIORITY||Odds Ratio (OR)|1.96||||0.258|TWO_SIDED|95.0|0.61|6.26|||Regression, Logistic|||||6.26|0.61|0.258
71943244|NCT03435081|143408116|SUPERIORITY||Odds Ratio (OR)|2.99||||0.052|TWO_SIDED|95.0|0.99|8.97|||Regression, Logistic|||||8.97|0.99|0.052
71943245|NCT04320849|143408120|OTHER||Slope|0.0675|||||ONE_SIDED|90.0||0.106||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the extravenous region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.106||
71943246|NCT04320849|143408121|OTHER||Slope|0.199|||||ONE_SIDED|90.0||0.397||||||"The following set of hypotheses will be used to evaluate the relationship between lead stiffness and curvature in the intracardiac region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.397||
71943247|NCT04320849|143408122|OTHER||Slope|-0.015|||||ONE_SIDED|90.0||0.0123||||||"The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the connector region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error."||0.0123||
71943248|NCT00705536|143408127|SUPERIORITY_OR_OTHER|||||||0.0006||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0006
71943249|NCT00705536|143408127|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
71943250|NCT00705536|143408128|SUPERIORITY_OR_OTHER|||||||0.0003||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0003
71943251|NCT00705536|143408128|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71943252|NCT00705536|143408129|SUPERIORITY_OR_OTHER|||||||0.0059||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0059
71943253|NCT00705536|143408129|SUPERIORITY_OR_OTHER|||||||0.0105||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0105
71943254|NCT00705536|143408130|SUPERIORITY_OR_OTHER|||||||0.0002||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0002
71943255|NCT00705536|143408130|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71943256|NCT00705536|143408131|SUPERIORITY_OR_OTHER|||||||0.3019||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.3019
71943257|NCT00705536|143408132|SUPERIORITY_OR_OTHER|||||||0.0401||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0401
71943258|NCT00705536|143408132|SUPERIORITY_OR_OTHER|||||||0.0004||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0004
71943259|NCT00705536|143408133|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog +rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71943260|NCT00705536|143408133|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||<0.0001
71695562|NCT02858401|142906109|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695563|NCT02858401|142906109|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71943261|NCT00705536|143408135|SUPERIORITY_OR_OTHER|||||||0.5589||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.5589
71943262|NCT00705536|143408135|SUPERIORITY_OR_OTHER|||||||0.0067||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA|||||||0.0067
71943263|NCT02289963|143408144|SUPERIORITY||Least Square (LS) Mean Difference|-63.4|||<|0.0001|TWO_SIDED|95.0|-71.6|-55.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W|Alirocumab group was compared to placebo group using an appropriate contrast statement.||-55.2|-71.6|<0.0001
71943264|NCT02289963|143408145|SUPERIORITY||LS Mean Difference|-66.2|||<|0.0001|TWO_SIDED|95.0|-73.9|-58.4||Threshold for significance was at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.||-58.4|-73.9|<0.0001
71943265|NCT02289963|143408146|SUPERIORITY||LS Mean Difference|-62.5|||<|0.0001|TWO_SIDED|95.0|-68.8|-56.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-56.3|-68.8|<0.0001
71943266|NCT02289963|143408147|SUPERIORITY||LS Mean Difference|-63.1|||<|0.0001|TWO_SIDED|95.0|-69.2|-57.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-57.0|-69.2|<0.0001
71943267|NCT02289963|143408148|SUPERIORITY||LS Mean Difference|-46.3|||<|0.0001|TWO_SIDED|95.0|-53.0|-39.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-39.7|-53.0|<0.0001
71943268|NCT02289963|143408149|SUPERIORITY||LS Mean Difference|-49.2|||<|0.0001|TWO_SIDED|95.0|-55.3|-43.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-43.1|-55.3|<0.0001
71943269|NCT02289963|143408150|SUPERIORITY||LS Mean Difference|-51.5|||<|0.0001|TWO_SIDED|95.0|-58.4|-44.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-44.6|-58.4|<0.0001
71943270|NCT02289963|143408151|SUPERIORITY||LS Mean Difference|-54.2|||<|0.0001|TWO_SIDED|95.0|-60.6|-47.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-47.8|-60.6|<0.0001
71943271|NCT02289963|143408152|SUPERIORITY||LS Mean Difference|-35.2|||<|0.0001|TWO_SIDED|95.0|-40.3|-30.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-30.1|-40.3|<0.0001
71943272|NCT02289963|143408153|SUPERIORITY||LS Mean Difference|-46.1|||<|0.0001|TWO_SIDED|95.0|-51.2|-41.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-41.0|-51.2|<0.0001
71943273|NCT02289963|143408154|SUPERIORITY||LS Mean Difference|-51.2|||<|0.0001|TWO_SIDED|95.0|-56.4|-46.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-46.1|-56.4|<0.0001
71943274|NCT02289963|143408155|SUPERIORITY||LS Mean Difference|-35.8|||<|0.0001|TWO_SIDED|95.0|-39.7|-31.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant.||-31.9|-39.7|<0.0001
71943275|NCT02289963|143408156|SUPERIORITY||Odds Ratio (OR)|46.9|||<|0.0001|TWO_SIDED|95.0|18.4|119.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||119.4|18.4|<0.0001
71943276|NCT02289963|143408157|SUPERIORITY||Odds Ratio (OR)|70.0|||<|0.0001|TWO_SIDED|95.0|23.3|210.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||210.8|23.3|<0.0001
71943277|NCT02289963|143408158|SUPERIORITY||Adjusted Mean Difference|-33.611|||<|0.0001|TWO_SIDED|95.0|-41.883|-25.338||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||-25.338|-41.883|<0.0001
71943278|NCT02289963|143408159|SUPERIORITY||LS Mean Difference|7.5||||0.0029|TWO_SIDED|95.0|2.6|12.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||12.4|2.6|0.0029
71943279|NCT02289963|143408160|SUPERIORITY||LS Mean Difference|-4.515||||0.311|TWO_SIDED|95.0|-13.25|4.219||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).||4.219|-13.250|0.3110
71943280|NCT00549718|143408173|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71943281|NCT00549718|143408174|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED|95.0|||||Mixed Models Analysis|||||||<0.05
71943282|NCT00581139|143408211|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
71943283|NCT00581139|143408213|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71943284|NCT00581139|143408214|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71943285|NCT00581139|143408215|SUPERIORITY|||||||0.01|||||||Chi-squared|||||||.01
71943286|NCT00581139|143408216|SUPERIORITY|||||||0.02|||||||ANOVA|||||||.02
71943287|NCT00581139|143408217|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
71943288|NCT00581139|143408218|SUPERIORITY|||||||0.04|||||||ANOVA|||||||.04
71695564|NCT02858401|142906109|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71943289|NCT01136382|143408226|SUPERIORITY_OR_OTHER||LS mean difference|13.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|7.5|19.7||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||19.7|7.5|<0.0001
71943290|NCT01136382|143408227|SUPERIORITY_OR_OTHER||LS mean difference|0.06|STANDARD_ERROR_OF_MEAN|0.022||0.0047|TWO_SIDED|95.0|0.02|0.11||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p\<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.11|0.02|0.0047
71943291|NCT01136382|143408228|SUPERIORITY_OR_OTHER||LS mean difference|10.8|STANDARD_ERROR_OF_MEAN|3.0||0.0004|TWO_SIDED|95.0|4.9|16.7|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||16.7|4.9|0.0004
71943292|NCT01136382|143408229|SUPERIORITY_OR_OTHER||LS mean difference|0.04|STANDARD_ERROR_OF_MEAN|0.02||0.0673|TWO_SIDED|95.0|0.0|0.08|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.08|0.00|0.0673
71695565|NCT02858401|142906110|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695566|NCT02858401|142906110|OTHER|||||||0.4047|||||||Wilcoxon rank sum test|||||||0.4047
71695567|NCT02858401|142906110|OTHER|||||||0.4652|||||||Wilcoxon rank sum test|||||||0.4652
71695568|NCT02858401|142906111|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71695569|NCT02858401|142906111|OTHER|||||||0.1757|||||||Wilcoxon rank sum test|||||||0.1757
71695570|NCT02858401|142906111|OTHER|||||||0.223|||||||Wilcoxon rank sum test|||||||0.2230
71695571|NCT02858401|142906114|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695572|NCT02858401|142906114|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695573|NCT02858401|142906114|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695574|NCT02858401|142906114|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695575|NCT02858401|142906114|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695576|NCT02858401|142906114|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695577|NCT02858401|142906115|OTHER|||||||0.3333|||||||Fisher Exact|||||||0.3333
71695578|NCT02858401|142906116|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695579|NCT02858401|142906116|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695580|NCT02858401|142906116|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695581|NCT02858401|142906116|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695582|NCT02858401|142906116|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695583|NCT02858401|142906116|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695584|NCT02858401|142906117|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695585|NCT02858401|142906117|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695586|NCT02858401|142906117|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695587|NCT02858401|142906117|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695588|NCT02858401|142906117|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695589|NCT02858401|142906117|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695590|NCT02858401|142906118|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695591|NCT02858401|142906118|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695592|NCT02858401|142906118|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695593|NCT02858401|142906119|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695594|NCT02858401|142906119|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695595|NCT02858401|142906119|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695596|NCT02858401|142906121|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695597|NCT02858401|142906121|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695598|NCT02858401|142906121|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71695599|NCT02513550|142906122|SUPERIORITY||Risk Difference (RD)|7.9|||=|0.005|TWO_SIDED||||||Regression, Logistic|||||||=0.005
71695600|NCT02513550|142906122|SUPERIORITY||Risk Difference (RD)|1.9|||=|0.522|TWO_SIDED||||||Regression, Logistic|||||||=0.522
71695601|NCT02513550|142906123|SUPERIORITY||Risk Difference (RD)|6.9|||=|0.006|TWO_SIDED||||||Regression, Logistic|||||||=0.006
71695602|NCT02513550|142906123|SUPERIORITY||Risk Difference (RD)|4.6|||=|0.118|TWO_SIDED||||||Regression, Logistic|||||||=0.118
71695603|NCT01663402|142906177|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.0003|TWO_SIDED|95.0|0.78|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).||0.93|0.78|0.0003
71695604|NCT01663402|142906178|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.0013|TWO_SIDED|95.0|0.81|0.95||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.||0.95|0.81|0.0013
71695605|NCT01663402|142906179|SUPERIORITY||Hazard Ratio (HR)|0.88||||0.006|TWO_SIDED|95.0|0.8|0.96||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.96|0.80|0.0060
71695606|NCT01663402|142906180|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.0003|TWO_SIDED|95.0|0.81|0.94||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.94|0.81|0.0003
71695607|NCT01663402|142906181|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.0003|TWO_SIDED|95.0|0.79|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||0.93|0.79|0.0003
71695608|NCT01663402|142906182|SUPERIORITY||Hazard Ratio (HR)|0.92||||0.3824|TWO_SIDED|95.0|0.76|1.11||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).||1.11|0.76|0.3824
71695609|NCT03924323|142906195|SUPERIORITY||least squares mean difference|-1.42||||0.0281|TWO_SIDED|95.0|-2.69|-0.15|||mixed-effects model for repeated measure|||||-0.15|-2.69|0.0281
71695610|NCT03924323|142906196|SUPERIORITY||Odds Ratio (OR)|1.253||||0.4521|TWO_SIDED|95.0|0.695|2.258|||generalized linear mixed model (GLMMIX)|||||2.258|0.695|0.4521
71695611|NCT03924323|142906197|SUPERIORITY||Odds Ratio (OR)|1.157||||0.6928|TWO_SIDED|95.0|0.56|2.387|||generalized linear mixed model (GLMMIX)|||||2.387|0.560|0.6928
71695612|NCT02240667|142906305|OTHER|||||||0.8496|||||||stratified log-rank test|||Persistence in both treatment groups was compared by means of the stratified Log-rank test||||0.8496
71943293|NCT01136382|143408230|SUPERIORITY_OR_OTHER||LS mean difference|0.1|STANDARD_ERROR_OF_MEAN|0.044||0.0216|TWO_SIDED|95.0|0.01|0.19|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||0.19|0.01|0.0216
71943294|NCT01136382|143408231|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06||0.0004|TWO_SIDED|95.0|-0.31|-0.09||Analysis for change in daytime asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.09|-0.31|0.0004
71943295|NCT01136382|143408231|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.11||0.0015|TWO_SIDED|95.0|-0.55|-0.13||Analysis for change in total asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.13|-0.55|0.0015
71943296|NCT01136382|143408232|SUPERIORITY_OR_OTHER||LS mean difference|-0.1|STANDARD_ERROR_OF_MEAN|0.06||0.0079|TWO_SIDED|95.0|-0.26|-0.04|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.04|-0.26|0.0079
71943297|NCT01136382|143408233|SUPERIORITY_OR_OTHER||LS mean difference|-4.7|STANDARD_ERROR_OF_MEAN|1.78||0.0095|TWO_SIDED|95.0|-8.2|-1.1||Analysis for change in nighttime awakenings from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.1|-8.2|0.0095
71943298|NCT01136382|143408233|SUPERIORITY_OR_OTHER||LS mean difference|-3.9|STANDARD_ERROR_OF_MEAN|1.15||0.0007|TWO_SIDED|95.0|-6.2|-1.7||Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-1.7|-6.2|0.0007
71943299|NCT01136382|143408234|SUPERIORITY_OR_OTHER||LS mean difference|-0.3|STANDARD_ERROR_OF_MEAN|0.07||0.0001|TWO_SIDED|95.0|-0.4|-0.1||Analysis for change in daytime reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.4|0.0001
71943300|NCT01136382|143408234|SUPERIORITY_OR_OTHER||LS mean difference|-0.5|STANDARD_ERROR_OF_MEAN|0.11|<|0.0001|TWO_SIDED|95.0|-0.7|-0.2||Analysis for change in total reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.2|-0.7|<0.0001
71943301|NCT01136382|143408235|SUPERIORITY_OR_OTHER||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.3|-0.1|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (\<8 years and ≥8 years of age) and country with baseline as a covariate.||-0.1|-0.3|<0.0001
71943302|NCT01136382|143408236|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Log Rank|||||||0.0004
71943303|NCT00963482|143408237|SUPERIORITY_OR_OTHER||||||=|0.111||95.0||||not adjusted for multiple comparisons due to only two groups p\<.05, two-tailed|Chi-squared|||"H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CG"||||=.111
71943304|NCT01045096|143408253|SUPERIORITY_OR_OTHER|||||||0.809||90.0|||||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.||||0.809
71943305|NCT01045096|143408254|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.2|||||TWO_SIDED|90.0|0.66|2.183|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.183|0.660|
71943306|NCT01045096|143408254|SUPERIORITY_OR_OTHER||Dose proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.463|2.427|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||2.427|0.463|
71943307|NCT01045096|143408254|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|0.88|||||TWO_SIDED|90.0|0.493|1.579|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.||1.579|0.493|
71695613|NCT00791999|142906359|SUPERIORITY_OR_OTHER||||||<|0.025||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.||||<0.025
71695614|NCT00791999|142906360|SUPERIORITY_OR_OTHER||||||<|0.05||95.0||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||||||<0.05
71695615|NCT01077323|142906361|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.59|1.28|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||1.28|0.59|
71695616|NCT01077323|142906362|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.1|||||TWO_SIDED|95.0|0.8|1.5|||||ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.Rate ratios adjusted for propensity score of exenatide initiation using Cox Proportional Hazards Regression|||1.5|0.8|
71695617|NCT01077323|142906363|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|0.87|||||TWO_SIDED|95.0|0.36|2.09|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.09|0.36|
71695618|NCT01077323|142906364|SUPERIORITY_OR_OTHER||Adjusted Rate Ratio (ARR)|1.39|||||TWO_SIDED|95.0|0.86|2.25|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."|||2.25|0.86|
71695619|NCT00427908|142906378|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for rSBA-MenA.|Difference in percentage|6.44|||||TWO_SIDED|95.0|1.15|16.04||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.||16.04|1.15|
71695620|NCT00427908|142906378|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenC.|Difference in percentage|13.18|||||TWO_SIDED|95.0|4.79|24.32||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.||24.32|4.79|
71695621|NCT00427908|142906378|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenW-135.|Difference in percentage|4.41|||||TWO_SIDED|95.0|1.51|12.21||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.||12.21|1.51|
71695622|NCT00427908|142906378|NON_INFERIORITY|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrux minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenY.|Difference in percentage|16.23|||||TWO_SIDED|95.0|8.99|26.78||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.||26.78|8.99|
71695623|NCT00427908|142906381|NON_INFERIORITY|Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Meningitec Group) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the predefined clinical limit of -15%.|Difference in vaccine response rate|1.47|||||TWO_SIDED|95.0|-0.27|7.89||||||To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.||7.89|-0.27|
71695624|NCT02984982|142906459|SUPERIORITY||LS mean difference|-1.64|STANDARD_ERROR_OF_MEAN|1.36||0.2279|TWO_SIDED|95.0|-4.32|1.04||Threshold for significance at 0.05 level.|ANCOVA||Standard of Care vs Alirocumab|Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.||1.04|-4.32|0.2279
71943308|NCT01045096|143408255|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.13|||||TWO_SIDED|90.0|0.693|1.848|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.848|0.693|
71943309|NCT01045096|143408255|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.15|||||TWO_SIDED|90.0|0.584|2.276|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||2.276|0.584|
71943310|NCT01045096|143408255|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.02|||||TWO_SIDED|90.0|0.632|1.642|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-tlqc\]. Pairwise comparisons between regimens were conducted.||1.642|0.632|
71943311|NCT01045096|143408256|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.06|||||TWO_SIDED|90.0|0.692|1.636|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.636|0.692|
71943312|NCT01045096|143408256|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.26|||||TWO_SIDED|90.0|0.691|2.314|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||2.314|0.691|
71943313|NCT01045096|143408256|SUPERIORITY_OR_OTHER||Dose Proportionality Point Estimate|1.19|||||TWO_SIDED|95.0|0.777|1.817|||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC\[0-24\]. Pairwise comparisons between regimens were conducted.||1.817|0.777|
71943314|NCT00324168|143408264|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.009||||0.82|TWO_SIDED|95.0|-0.085|0.068|||Regression, Linear|Adjusted for enrollment BSCVA||||0.068|-0.085|0.82
71943315|NCT00324168|143408265|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.4|TWO_SIDED|95.0|-0.09|0.15|||Regression, Linear|||||0.15|-0.09|0.40
71943316|NCT00324168|143408266|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.873|TWO_SIDED|95.0|-0.07|0.08|||Regression, Linear|||||0.08|-0.07|0.873
71943317|NCT00324168|143408267|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.92||||0.44|TWO_SIDED|95.0|0.76|1.12|||Regression, Cox|||||1.12|0.76|0.44
71943318|NCT00324168|143408268|SUPERIORITY_OR_OTHER||||||>|0.99||95.0|||||Fisher Exact|||||||>0.99
71943319|NCT00324168|143408269|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.39|TWO_SIDED|95.0|-0.12|0.05|||Regression, Linear|||||0.05|-0.12|0.39
71943320|NCT00324168|143408270|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01|STANDARD_ERROR_OF_MEAN|0.04||0.78||95.0|-0.09|0.07|||Regression, Linear|||||0.07|-0.09|0.78
71943321|NCT00324168|143408271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.12||||0.3|TWO_SIDED|95.0|-0.011|0.35|||Regression, Linear|||Nocardia spp||0.35|-.011|0.30
71943322|NCT00324168|143408271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.01||||0.86||95.0|-0.12|0.1|||Regression, Linear|||Streptococcus pneumoniae||0.10|-0.12|0.86
71943323|NCT00324168|143408271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.65|TWO_SIDED|95.0|-0.34|0.55|||Regression, Linear|||Moraxella spp||0.55|-0.34|0.65
71943324|NCT00324168|143408271|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.04||||0.67|TWO_SIDED|95.0|-0.2|0.13|||Regression, Linear|||Pseudomonas aeruginosa||0.13|-0.20|0.67
71943325|NCT00324168|143408272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.08||||0.33|TWO_SIDED|95.0|-0.08|0.25|||Regression, Linear|||\<20/40||0.25|-0.08|0.33
71943326|NCT00324168|143408272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.85|TWO_SIDED|95.0|-0.09|0.11|||Regression, Linear|||20/40 to 20/800||0.11|-0.09|0.85
71943327|NCT00324168|143408272|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.03|TWO_SIDED|95.0|-0.31|-0.02|||Regression, Linear|||CF or worse||-0.02|-0.31|0.03
71943328|NCT00324168|143408273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.06||||0.31|TWO_SIDED|95.0|-0.05|0.17|||Regression, Linear|||\>0-33%||0.17|-0.05|0.31
71943329|NCT00324168|143408273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.94|TWO_SIDED|95.0|-0.13|0.14|||Regression, Linear|||\>33%-67%||0.14|-0.13|0.94
71943330|NCT00324168|143408273|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||\>67%-100%||0.01|-0.31|0.07
71943331|NCT00324168|143408274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.53|TWO_SIDED|95.0|-0.1|0.2|||Regression, Linear|||0-1.90 mm||0.20|-0.10|0.53
71943332|NCT00324168|143408274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.95|TWO_SIDED|95.0|-0.15|0.16|||Regression, Linear|||1.91-2.70 mm||0.16|-0.15|0.95
71943333|NCT00324168|143408274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.03||||0.7|TWO_SIDED|95.0|-0.12|0.18|||Regression, Linear|||2.71-4.06 mm||0.18|-0.12|0.70
71943334|NCT00324168|143408274|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.15||||0.07|TWO_SIDED|95.0|-0.31|0.01|||Regression, Linear|||4.07-8.90 mm||0.01|-0.31|0.07
71943335|NCT03497897|143408278|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|Posterior geometric mean ratio|0.93|||||TWO_SIDED|90.0|0.64|1.34|||Bayesian analysis|Bayesian mixed effect model with repeated measures|90% credible intervals are reported on the geometric means ratio|||1.34|0.64|
71943336|NCT03497897|143408278|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<1)|0.637|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
71943337|NCT03497897|143408278|OTHER|The effects included in the model are: log transformed baseline inflammatory facial lesion count, treatment group, visit, treatment group by visit interaction, log transformed baseline inflammatory facial lesion count by visit interaction and type of center.|P(Geometric Mean Ratio<0.75)|0.171|||||||||||Bayesian analysis|Bayesian mixed effect model with repeated measures|Posterior probability on geometric mean ratio is reported.|||||
71943338|NCT01643707|143408284|SUPERIORITY|A chi-square test was performed to determine a difference between Phase 1 and Phase 2.|||||<|1e-05|||||||Chi-squared|||||||<0.00001
71943339|NCT01643707|143408285|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001|||||||Chi-squared|||||||<0.0001
71943340|NCT01643707|143408286|EQUIVALENCE|Chi-Square test used to show any difference between Phase 1 and Phase 2|||||<|0.0001||||||This endpoint was covered in primary objective 2, so this analysis is the same as previously reported.|Chi-squared||||See Primary Objectives for additional details.|||<0.0001
71943341|NCT01391793|143408291|SUPERIORITY|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.||||0.16
71943342|NCT01391793|143408292|SUPERIORITY|||||||0.25|||||||Test of equality - 2 Poisson parameters|The method used is a conditional test.||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.||||0.25
71943343|NCT01391793|143408293|SUPERIORITY|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (\<24 months, \>=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.||||0.07
71695625|NCT02616783|142906489|SUPERIORITY||Difference in Percentages|2.427|||<|0.001|TWO_SIDED|95.0|1.337|3.517|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||3.517|1.337|<0.001
71695626|NCT02616783|142906490|SUPERIORITY||Difference in percentages|2.036|||<|0.001|TWO_SIDED|95.0|1.168|2.904|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.904|1.168|<0.001
71695627|NCT02616783|142906491|SUPERIORITY||Difference in percentages|1.749|||<|0.001|TWO_SIDED|95.0|0.726|2.771|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|||2.771|0.726|<0.001
71695628|NCT02616783|142906492|SUPERIORITY||Difference in percentages|1.351|||<|0.001|TWO_SIDED|95.0|0.602|2.099|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|||2.099|0.602|<0.001
71943344|NCT02087904|143408300|SUPERIORITY||LS Mean Difference|-0.3||||0.834|TWO_SIDED|95.0|-3.13|2.53||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and Kellgren-Lawrence (K-L) grade as the main factors and baseline as a covariate.|ANCOVA|||||2.53|-3.13|0.834
71943345|NCT02087904|143408300|SUPERIORITY||LS Mean Difference|-2.9||||0.05|TWO_SIDED|95.0|-5.73|0.01||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.01|-5.73|0.05
71943346|NCT02087904|143408300|SUPERIORITY||LS Mean Difference|-1.2||||0.415|TWO_SIDED|95.0|-4.0|1.66||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.66|-4.00|0.415
71943347|NCT02087904|143408301|SUPERIORITY||LS Mean Difference|0.06||||0.145|TWO_SIDED|95.0|-0.021|0.141||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.141|-0.021|0.145
71943348|NCT02087904|143408301|SUPERIORITY||LS Mean Difference|-0.03||||0.52|TWO_SIDED|95.0|-0.11|0.056||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.056|-0.11|0.52
71695629|NCT02616783|142906493|SUPERIORITY||Difference in percentages|-5.5||||0.18|TWO_SIDED|95.0|-11.8|1.6||P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Fisher Exact||Differences in percentages and 95% CI were generated based on exact method.|||1.6|-11.8|0.18
71943349|NCT02087904|143408301|SUPERIORITY||LS Mean Difference|0.06||||0.159|TWO_SIDED|95.0|-0.023|0.139||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.139|-0.023|0.159
71943350|NCT02087904|143408302|SUPERIORITY||LS Mean Difference|0.22||||0.897|TWO_SIDED|95.0|-3.193|3.642||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||3.642|-3.193|0.897
71943351|NCT02087904|143408302|SUPERIORITY||LS Mean Difference|-1.07||||0.542|TWO_SIDED|95.0|-4.515|2.377||P-value for test of difference between ABT-981 100 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.377|-4.515|0.542
71943352|NCT02087904|143408302|SUPERIORITY||LS Mean Difference|-1.52||||0.385|TWO_SIDED|95.0|-4.95|1.916||P-value for test of difference between ABT-981 200 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.916|-4.95|0.385
71943353|NCT02087904|143408303|SUPERIORITY||LS Mean Difference|-0.08||||0.384|TWO_SIDED|95.0|-0.249|0.096||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.096|-0.249|0.384
71943354|NCT02087904|143408303|SUPERIORITY||LS Mean Difference|-0.15||||0.095|TWO_SIDED|95.0|-0.324|0.026||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.026|-0.324|0.095
71943355|NCT02087904|143408303|SUPERIORITY||LS Mean Difference|-0.14||||0.106|TWO_SIDED|95.0|-0.314|0.03||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.03|-0.314|0.106
71943356|NCT02087904|143408304|SUPERIORITY||LS Mean Difference|-1.1||||0.818|TWO_SIDED|95.0|-10.22|8.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||8.08|-10.22|0.818
71943357|NCT02087904|143408304|SUPERIORITY||LS Mean Difference|-7.6||||0.109|TWO_SIDED|95.0|-16.83|1.69||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.69|-16.83|0.109
71943358|NCT02087904|143408304|SUPERIORITY||LS Mean Difference|-3.4||||0.465|TWO_SIDED|95.0|-12.58|5.76||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.76|-12.58|0.465
71943359|NCT02087904|143408305|SUPERIORITY||LS Mean Difference|-2.1||||0.666|TWO_SIDED|95.0|-11.76|7.52||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.52|-11.76|0.666
71943360|NCT02087904|143408305|SUPERIORITY||LS Mean Difference|-9.2||||0.065|TWO_SIDED|95.0|-18.95|0.56||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.56|-18.95|0.065
71943361|NCT02087904|143408305|SUPERIORITY||LS Mean Difference|-7.2||||0.145|TWO_SIDED|95.0|-16.84|2.49||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.49|-16.84|0.145
71943362|NCT02087904|143408306|SUPERIORITY||LS Mean Difference|-3.2||||0.558|TWO_SIDED|95.0|-14.03|7.59||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||7.59|-14.03|0.558
71943363|NCT02087904|143408306|SUPERIORITY||LS Mean Difference|-5.8||||0.295|TWO_SIDED|95.0|-16.77|5.11||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||5.11|-16.77|0.295
71943364|NCT02087904|143408306|SUPERIORITY||LS Mean Difference|-6.8||||0.218|TWO_SIDED|95.0|-17.63|4.04||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||4.04|-17.63|0.218
71695630|NCT02616783|142906494|SUPERIORITY||Difference in percentages|-1.0||||1|TWO_SIDED|95.0|-8.5|9.3|||Fisher Exact|P-values for the superiority test comparing the percentages of participants with HIV-1 RNA \< 50 copies/mL were from the Fisher exact test.|Differences in percentages and 95% CI were generated based on exact method.|||9.3|-8.5|1.00
71943365|NCT02087904|143408307|SUPERIORITY||LS Mean Difference|-0.6||||0.664|TWO_SIDED|95.0|-3.58|2.28||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.28|-3.58|0.664
71943366|NCT02087904|143408307|SUPERIORITY||LS Mean Difference|-2.7||||0.075|TWO_SIDED|95.0|-5.67|0.28||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.28|-5.67|0.075
71943367|NCT02087904|143408307|SUPERIORITY||LS Mean Difference|-2.4||||0.107|TWO_SIDED|95.0|-5.33|0.52||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.52|-5.33|0.107
71943368|NCT02087904|143408308|SUPERIORITY||LS Mean Difference|0.5||||0.5|TWO_SIDED|95.0|-4.26|2.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||2.08|-4.26|0.5
71943369|NCT02087904|143408308|SUPERIORITY||LS Mean Difference|-2.2||||0.186|TWO_SIDED|95.0|-5.39|1.05||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||1.05|-5.39|0.186
71943370|NCT02087904|143408308|SUPERIORITY||LS Mean Difference|-2.3||||0.157|TWO_SIDED|95.0|-5.46|0.88||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.88|-5.46|0.157
71943371|NCT02087904|143408309|SUPERIORITY||LS Mean Difference|0.2||||0.319|TWO_SIDED|95.0|-0.23|0.69||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.69|-0.23|0.319
71943372|NCT02087904|143408309|SUPERIORITY||LS Mean Difference|-0.1||||0.564|TWO_SIDED|95.0|-0.6|0.33||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.33|-0.6|0.564
71943373|NCT02087904|143408309|SUPERIORITY||LS Mean Difference|0.0||||0.966|TWO_SIDED|95.0|-0.45|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.47|-0.45|0.966
71943374|NCT02087904|143408310|SUPERIORITY||LS Mean Difference|0.1||||0.602|TWO_SIDED|95.0|-0.41|0.7||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.7|-0.41|0.602
71695631|NCT02616783|142906495|SUPERIORITY||Difference in LSM|52.0||||0.053|TWO_SIDED|95.0|-1.0|106.0|||ANOVA|The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.||||106|-1|0.053
71695632|NCT02616783|142906496|SUPERIORITY||Difference in LSM|57.0||||0.051|TWO_SIDED|95.0|0.0|115.0|||ANOVA|The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.||||115|0|0.051
71943375|NCT02087904|143408310|SUPERIORITY||LS Mean Difference|0.0||||0.953|TWO_SIDED|95.0|-0.55|0.58||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.58|-0.55|0.953
71943376|NCT02087904|143408310|SUPERIORITY||LS Mean Difference|-0.1||||0.83|TWO_SIDED|95.0|-0.61|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.61|0.83
71943377|NCT02087904|143408311|SUPERIORITY||LS Mean Difference|0.7||||0.804|TWO_SIDED|95.0|-4.91|6.33||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.33|-4.91|0.804
71943378|NCT02087904|143408311|SUPERIORITY||LS Mean Difference|-1.1||||0.699|TWO_SIDED|95.0|-6.9|4.63||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.63|-6.9|0.699
71943379|NCT02087904|143408311|SUPERIORITY||LS Mean Difference|1.4||||0.636|TWO_SIDED|95.0|-4.37|7.14||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||7.14|-4.37|0.636
71943380|NCT02087904|143408311|SUPERIORITY||LS Mean Difference|0.9||||0.756|TWO_SIDED|95.0|-4.91|6.76||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||6.76|-4.91|0.756
71943381|NCT02087904|143408311|SUPERIORITY||LS Mean Difference|-5.6||||0.068|TWO_SIDED|95.0|-11.55|0.42||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||0.42|-11.55|0.068
71943382|NCT02087904|143408311|SUPERIORITY||LS Mean Difference|-1.4||||0.649|TWO_SIDED|95.0|-7.34|4.58||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.58|-7.34|0.649
71943383|NCT02087904|143408312|SUPERIORITY||LS Mean Difference|-1.0||||0.75|TWO_SIDED|95.0|-7.14|5.14||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||5.14|-7.14|0.75
71943384|NCT02087904|143408312|SUPERIORITY||LS Mean Difference|-2.6||||0.409|TWO_SIDED|95.0|-8.82|3.6||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.6|-8.82|0.409
71943385|NCT02087904|143408312|SUPERIORITY||LS Mean Difference|-3.0||||0.338|TWO_SIDED|95.0|-9.24|3.18||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.18|-9.24|0.338
71943386|NCT02087904|143408312|SUPERIORITY||LS Mean Difference|0.7||||0.817|TWO_SIDED|95.0|-5.59|7.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||7.08|-5.59|0.817
71943387|NCT02087904|143408312|SUPERIORITY||LS Mean Difference|-2.0||||0.544|TWO_SIDED|95.0|-8.37|4.43||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||4.43|-8.37|0.544
71943388|NCT02087904|143408312|SUPERIORITY||LS Mean Difference|-2.5||||0.437|TWO_SIDED|95.0|-8.91|3.86||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||3.86|-8.91|0.437
71695633|NCT04010461|142906533|SUPERIORITY||Mean Difference (Final Values)|0.159|STANDARD_ERROR_OF_MEAN|0.097|=|0.11|TWO_SIDED|95.0|-0.037|0.355|||t-test, 2 sided|df = 35 Note: 1 subject was excluded from analysis as extraction of FPN eigenvalues failed due to technical deficiencies with image data||Analysis used standard, open-source methods for pre-processing . First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters. Statistical testing was done to establish whether more or less BOLD (neural activity) change occurred between two conditions.||0.355|-0.037|=0.11
71695634|NCT04010461|142906533|SUPERIORITY||Mean Difference (Final Values)|-0.009|STANDARD_ERROR_OF_MEAN|0.116||0.94|TWO_SIDED|95.0|-0.245|0.227|||t-test, 2 sided|df = 35 Note: 1 subject excluded from analysis as FPN extraction of eigenvalues failed due to technical issues with image data||Analysis used standard, open-source routes for slice timing correction, field map correction, realignment, smoothing (6 mm Gaussian kernel) and spatial normalization (MNI-152). First-level analysis used the general framework of the modified General Linear Model, implemented in SPM12 with temporal convolution. For the n-back activation task, the first-level design matrix included regressors for 2-back and 1-back conditions, as well as 24 movement parameters.||0.227|-0.245|0.94
71695635|NCT04010461|142906534|OTHER|Group-level analyses were performed using a General Linear Model (GLM). For each individual voxel, a separate GLM was estimated, with first-level connectivity measures at this voxel as dependent variables, and groups or other subject-level identifiers as independent variables. Voxel-level hypotheses were evaluated using multivariate parametric statistics with random effects across subjects and sample covariance estimation across multiple measurements.|random field theory|0.0||||1|TWO_SIDED|||||Inferences were performed at the level of individual clusters (groups of contiguous voxels). Cluster-level inferences were based on parametric statistics from Gaussian Random Field theory.|random field theory|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and cluster-size threshold of 25 voxels|Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs active)|The contrast reflects the difference in connectivity between the conditions/sessions, at the level of each subject, then spatially averaged across all subjects. Functional connectivity strength for the dlPFC seed was represented by Fisher-transformed bivariate correlation coefficients from a weighted general linear model (weighted-GLM), defined separately for each pair of seed and target areas, modeling the association between their BOLD signal time series.||||1
71695636|NCT04010461|142906534|OTHER|The applied test with random field theory uses a metric of spatial dispersion, testing against the null hypothesis that spatial clusters of difference across the analyzed region are no different from chance clustering.|random field theory|0.0||||1|TWO_SIDED||||||random field theory||Number indicates the number of clusters above the threshold of significance for the contrast between two arms (passive vs control)|Results were thresholded using a combination of a cluster-forming p \< 0.001 voxel-level threshold, and a corrected false discovery rate (FDR) p \< 0.05 cluster-size threshold.||||1
71695637|NCT04010461|142906535|SUPERIORITY||F-ratio|0.1||||0.91|TWO_SIDED||||||ANOVA|||||||0.91
71695638|NCT04010461|142906536|SUPERIORITY|||||||0.55|||||||ANOVA|||||||0.55
71695639|NCT04010461|142906536|SUPERIORITY|||||||0.65|||||||ANOVA|||||||.65
71695640|NCT04010461|142906537|OTHER||cluster size|42.0||||0.54|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Active, testing whether the cluster size is greater than chance.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain.||||0.54
71943389|NCT02087904|143408313|SUPERIORITY||LS Mean Difference|-2.2||||0.545|TWO_SIDED|95.0|-9.31|4.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||4.92|-9.31|0.545
71943390|NCT02087904|143408313|SUPERIORITY||LS Mean Difference|-0.4||||0.909|TWO_SIDED|95.0|-7.65|6.81||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||6.81|-7.65|0.909
71943391|NCT02087904|143408313|SUPERIORITY||LS Mean Difference|-4.0||||0.278|TWO_SIDED|95.0|-11.23|3.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain||3.25|-11.23|0.278
71695641|NCT04010461|142906537|SUPERIORITY||cluster size|16.0||||0.93|TWO_SIDED|||||P-value above represents the lowest (most significant) value of the largest cluster, for the contrast of Passive \> Control, testing whether the size of this cluster is greater than one would expect by chance alone.|random field theory||The estimated parameter is the size, in voxels, of the largest cluster. The applied test with random field theory tests whether the size of cluster difference across are no different from chance clustering.|Statistical thresholding using a random field model adjusted for multiple comparisons, with initial voxel magnitude/height threshold set at p \< 0.001 and peak and cluster-corrected significance levels obtained (false discovery rate \[FDR\]corrected), across the entire brain..||||0.93
71943392|NCT02087904|143408313|SUPERIORITY||LS Mean Difference|-1.2||||0.732|TWO_SIDED|95.0|-8.42|5.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||5.92|-8.42|0.732
71943393|NCT02087904|143408313|SUPERIORITY||LS Mean Difference|-4.6||||0.216|TWO_SIDED|95.0|-11.86|2.69||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||2.69|-11.86|0.216
71943394|NCT02087904|143408313|SUPERIORITY||LS Mean Difference|-9.2||||0.014|TWO_SIDED|95.0|-16.42|-1.88||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain||-1.88|-16.42|0.014
71943395|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.0||||0.874|TWO_SIDED|95.0|-0.56|0.66||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.66|-0.56|0.874
71943396|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|-0.2||||0.451|TWO_SIDED|95.0|-0.86|0.38||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.38|-0.86|0.451
71943397|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.3||||0.331|TWO_SIDED|95.0|-0.31|0.93||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.93|-0.31|0.331
71943398|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.0||||0.932|TWO_SIDED|95.0|-0.73|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-0.73|0.932
71943399|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|-0.3||||0.344|TWO_SIDED|95.0|-1.07|0.37||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.37|-1.07|0.344
71943400|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.3||||0.489|TWO_SIDED|95.0|-0.47|0.97||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.97|-0.47|0.489
71943401|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.2||||0.498|TWO_SIDED|95.0|-0.42|0.85||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.85|-0.42|0.498
71943402|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.2||||0.637|TWO_SIDED|95.0|-0.8|0.49||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.49|-0.8|0.637
71943403|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.3||||0.367|TWO_SIDED|95.0|-0.35|0.94||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.94|-0.35|0.367
71943404|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.1||||0.67|TWO_SIDED|95.0|-0.51|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.51|0.67
71943405|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|-0.1||||0.776|TWO_SIDED|95.0|-0.76|0.57||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.76|0.776
71943406|NCT02087904|143408314|SUPERIORITY||LS Mean Difference|0.3||||0.387|TWO_SIDED|95.0|-0.37|0.96||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.96|-0.37|0.387
71943407|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.2||||0.661|TWO_SIDED|95.0|-0.86|0.54||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.54|-0.86|0.661
71943408|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.6||||0.122|TWO_SIDED|95.0|-1.26|0.15||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.15|-1.26|0.122
71943409|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.2||||0.507|TWO_SIDED|95.0|-0.94|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.47|-0.94|0.507
71695642|NCT04010461|142906538|SUPERIORITY||F-ratio|0.22||||0.8|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to test for differences in cerebral blood flow (perfusion) in the frontoparietal network||||0.8
71943410|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.1||||0.892|TWO_SIDED|95.0|-0.85|0.74||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.74|-0.85|0.892
71943411|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.3||||0.433|TWO_SIDED|95.0|-1.12|0.48||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.48|-1.12|0.433
71943412|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|0.0||||0.92|TWO_SIDED|95.0|-0.84|0.76||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.76|-0.84|0.92
71943413|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|0.0||||0.957|TWO_SIDED|95.0|-0.68|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.71|-0.68|0.957
71943414|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.4||||0.222|TWO_SIDED|95.0|-1.13|0.26||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.26|-1.13|0.222
71943415|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.4||||0.209|TWO_SIDED|95.0|-1.15|0.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.25|-1.15|0.209
71943416|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|0.1||||0.813|TWO_SIDED|95.0|-0.62|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.79|-0.62|0.813
71943417|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.5||||0.135|TWO_SIDED|95.0|-1.25|0.17||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.17|-1.25|0.135
71943418|NCT02087904|143408315|SUPERIORITY||LS Mean Difference|-0.1||||0.679|TWO_SIDED|95.0|-0.85|0.57||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.57|-0.85|0.679
71943419|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|0.0||||0.978|TWO_SIDED|95.0|-0.76|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.79|-0.76|0.978
71943420|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|0.0||||0.925|TWO_SIDED|95.0|-0.75|0.82||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.82|-0.75|0.925
71943421|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.2||||0.659|TWO_SIDED|95.0|-0.96|0.61||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period||0.61|-0.96|0.659
71943422|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.2||||0.633|TWO_SIDED|95.0|-1.1|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.67|-1.1|0.633
71943423|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.3||||0.46|TWO_SIDED|95.0|-1.23|0.56||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.56|-1.23|0.46
71943424|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.2||||0.663|TWO_SIDED|95.0|-1.1|0.7||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain||0.7|-1.1|0.663
71943425|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.1||||0.696|TWO_SIDED|95.0|-0.89|0.59||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.59|-0.89|0.696
71695643|NCT04010461|142906539|SUPERIORITY||F-ratio|3.96||||0.06|TWO_SIDED||||||ANOVA|||||||0.06
71695644|NCT04010461|142906539|SUPERIORITY||F-ratio|0.17||||0.68|TWO_SIDED||||||ANOVA|||||||0.68
71943426|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.4||||0.278|TWO_SIDED|95.0|-1.16|0.34||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.34|-1.16|0.278
71943427|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.4||||0.357|TWO_SIDED|95.0|-1.1|0.4||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)||0.4|-1.1|0.357
71943428|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.1||||0.761|TWO_SIDED|95.0|-0.87|0.64||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.64|-0.87|0.761
71943429|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.5||||0.218|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-1.02|0.218
71943430|NCT02087904|143408316|SUPERIORITY||LS Mean Difference|-0.3||||0.513|TWO_SIDED|95.0|-1.02|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)||0.51|-1.02|0.513
71943431|NCT02087904|143408317|SUPERIORITY||LS Mean Difference|0.1||||0.728|TWO_SIDED|95.0|-0.52|0.75||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.75|-0.52|0.728
71943432|NCT02087904|143408317|SUPERIORITY||LS Mean Difference|-0.4||||0.219|TWO_SIDED|95.0|-1.06|0.24||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.24|-1.06|0.219
71943433|NCT02087904|143408317|SUPERIORITY||LS Mean Difference|-0.1||||0.673|TWO_SIDED|95.0|-0.79|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.51|-0.79|0.673
71943434|NCT02087904|143408318|SUPERIORITY||LS Mean Difference|0.0||||0.984|TWO_SIDED|95.0|-0.73|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.71|-0.73|0.984
71943435|NCT02087904|143408318|SUPERIORITY||LS Mean Difference|-0.5||||0.145|TWO_SIDED|95.0|-1.26|0.19||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.19|-1.26|0.145
71943436|NCT02087904|143408318|SUPERIORITY||LS Mean Difference|-0.2||||0.527|TWO_SIDED|95.0|-0.96|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.49|-0.96|0.527
71943437|NCT02087904|143408319|SUPERIORITY||LS Mean Difference|0.1||||0.836|TWO_SIDED|95.0|-0.71|0.87||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.87|-0.71|0.836
71943438|NCT02087904|143408319|SUPERIORITY||LS Mean Difference|-0.1||||0.738|TWO_SIDED|95.0|-0.94|0.66||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.66|-0.94|0.738
71943439|NCT02087904|143408319|SUPERIORITY||LS Mean Difference|-0.4||||0.3|TWO_SIDED|95.0|-1.22|0.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||||0.38|-1.22|0.3
71943440|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|0.5||||0.992|TWO_SIDED|95.0|-101.59|102.62||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||102.62|-101.59|0.992
71943441|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|3.6||||0.948|TWO_SIDED|95.0|-103.95|111.1||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||111.10|-103.95|0.948
71943442|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|-33.1||||0.523|TWO_SIDED|95.0|-134.76|68.65||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||68.65|-134.76|0.523
71943443|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|4.2||||0.799|TWO_SIDED|95.0|-28.47|36.95||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||36.95|-28.47|0.799
71943444|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|9.0||||0.609|TWO_SIDED|95.0|-25.62|43.64||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||43.64|-25.62|0.609
71943445|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|1.6||||0.923|TWO_SIDED|95.0|-30.97|34.19||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||34.19|-30.97|0.923
71943446|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|2.1||||0.937|TWO_SIDED|95.0|-49.88|54.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||54.08|-49.88|0.937
71943447|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|4.1||||0.882|TWO_SIDED|95.0|-50.68|58.95||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||58.95|-50.68|0.882
71943448|NCT02087904|143408320|SUPERIORITY||LS Mean Difference|13.8||||0.602|TWO_SIDED|95.0|-38.05|65.55||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||65.55|-38.05|0.602
71943449|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|-41.7||||0.554|TWO_SIDED|95.0|-180.49|97.04||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||97.04|-180.49|0.554
71943450|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|2.7||||0.97|TWO_SIDED|95.0|-140.86|146.31||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||146.31|-140.86|0.97
71943451|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|-26.1||||0.713|TWO_SIDED|95.0|-165.47|113.32||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||113.32|-165.47|0.713
71943452|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|-25.1||||0.272|TWO_SIDED|95.0|-70.12|19.88||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||19.88|-70.12|0.272
71943453|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|11.1||||0.64|TWO_SIDED|95.0|-35.63|57.8||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||57.8|-35.63|0.64
71943454|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|-11.8||||0.608|TWO_SIDED|95.0|-56.94|33.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||33.38|-56.94|0.608
71943455|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|-40.3||||0.319|TWO_SIDED|95.0|-119.88|39.3||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||39.3|-119.88|0.319
71943456|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|24.4||||0.56|TWO_SIDED|95.0|-58.05|106.91||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||106.91|-58.05|0.56
71943457|NCT02087904|143408321|SUPERIORITY||LS Mean Difference|-28.1||||0.489|TWO_SIDED|95.0|-107.97|51.82||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||51.82|-107.97|0.489
71943458|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|0.0||||0.972|TWO_SIDED|95.0|-0.015|0.015||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.015|0.972
71695645|NCT04010461|142906540|SUPERIORITY|Repeated measures ANOVA for 1- and 2-back conditions|F-ratio|0.72||||0.41|TWO_SIDED||||||ANOVA|||||||0.41
71695646|NCT04010461|142906540|SUPERIORITY|||||||0.5|||||||ANOVA|||||||0.50
71695647|NCT02027025|142906575|SUPERIORITY||LS mean difference|-0.48|STANDARD_ERROR_OF_MEAN|0.64||0.4532|TWO_SIDED|95.0|-1.73|0.78|||ANCOVA|||||0.78|-1.73|0.4532
71695648|NCT02027025|142906575|SUPERIORITY||LS mean difference|-0.47|STANDARD_ERROR_OF_MEAN|0.65||0.4704|TWO_SIDED|95.0|-1.76|0.82|||ANCOVA|||||0.82|-1.76|0.4704
71695649|NCT02027025|142906576|SUPERIORITY||LS mean difference|-0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3013|TWO_SIDED|95.0|-0.56|0.17|||ANCOVA|||||0.17|-0.56|0.3013
71695650|NCT02027025|142906576|SUPERIORITY||LS mean difference|-0.2|STANDARD_ERROR_OF_MEAN|0.19||0.2994|TWO_SIDED|95.0|-0.58|0.18|||ANCOVA|||||0.18|-0.58|0.2994
71695651|NCT02027025|142906577|SUPERIORITY|||||||0.3815|||||||Chi-squared|||||||0.3815
71695652|NCT02027025|142906577|SUPERIORITY|||||||0.7491|||||||Chi-squared|||||||0.7491
71695653|NCT02027025|142906578|SUPERIORITY|||||||0.8991|||||||Chi-squared|||||||0.8991
71695654|NCT02027025|142906578|SUPERIORITY|||||||0.8829|||||||Chi-squared|||||||0.8829
71695655|NCT02360488|142906579|NON_INFERIORITY|The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.|Mean Difference (Net)|0.06||||0.96|TWO_SIDED|95.0|-2.14|2.26|||Regression, Linear|The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.||||2.26|-2.14|.96
71695656|NCT01939314|142906580|SUPERIORITY_OR_OTHER||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|-13.0|27.1||||||||27.1|-13.0|
71695657|NCT01939314|142906582|SUPERIORITY_OR_OTHER||Risk Difference (RD)|24.7|||||TWO_SIDED|95.0|2.6|43.6||||||||43.6|2.6|
71695658|NCT04350827|142906591|SUPERIORITY|||||||0.433|||||||ANOVA|||||||0.433
71695659|NCT02357459|142906595|SUPERIORITY|The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.|Mean Difference (Final Values)|-0.98|STANDARD_ERROR_OF_MEAN|0.2|<|0.0001|TWO_SIDED|95.0|-1.47|-0.49||The threshold for significance was \<0.05.|longitudinal mixed repeated measures|||||-0.49|-1.47|<0.0001
71695660|NCT03256578|142906624|SUPERIORITY|||||||0.896|||||||Wilcoxon (Mann-Whitney)|||||||0.896
71695661|NCT03256578|142906625|SUPERIORITY|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||||||0.107
71695662|NCT03256578|142906626|SUPERIORITY|||||||0.847|||||||Wilcoxon (Mann-Whitney)|||||||0.847
71695663|NCT03256578|142906627|SUPERIORITY|||||||0.126|||||||Wilcoxon (Mann-Whitney)|||||||0.126
71695664|NCT03256578|142906628|SUPERIORITY|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||||||0.346
71695665|NCT03256578|142906629|SUPERIORITY|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||||||0.094
71695666|NCT03256578|142906630|SUPERIORITY|||||||0.656|||||||Wilcoxon (Mann-Whitney)|||||||0.656
71695667|NCT03256578|142906631|SUPERIORITY|||||||0.434|||||||Wilcoxon (Mann-Whitney)|||||||0.434
71695668|NCT03256578|142906632|SUPERIORITY|||||||0.903|||||||Wilcoxon (Mann-Whitney)|||||||0.903
71695669|NCT03256578|142906633|SUPERIORITY|||||||0.699|||||||Chi-squared|||||||0.699
71695670|NCT03256578|142906634|SUPERIORITY|||||||0.231|||||||Chi-squared|||||||0.231
71695671|NCT03256578|142906635|SUPERIORITY||Risk Ratio (RR)|0.593||||0.283|TWO_SIDED|95.0|0.225|1.561|||Chi-squared|||||1.561|0.225|0.283
71695672|NCT03256578|142906636|SUPERIORITY||Risk Ratio (RR)|1.864||||0.168|TWO_SIDED|95.0|0.756|4.599|||Chi-squared|||||4.599|0.756|0.168
71695673|NCT03256578|142906637|SUPERIORITY||Risk Ratio (RR)|0.67||||0.024|TWO_SIDED|95.0|0.474|0.947|||Chi-squared|||||0.947|0.474|0.024
71695674|NCT03256578|142906638|SUPERIORITY|||||||0.585|||||||Wilcoxon (Mann-Whitney)|||||||0.585
71695675|NCT03256578|142906639|SUPERIORITY|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||||||0.342
71695676|NCT03256578|142906640|SUPERIORITY|||||||0.431|||||||Wilcoxon (Mann-Whitney)|||||||0.431
71695677|NCT03256578|142906642|SUPERIORITY||Risk Ratio (RR)|1.059||||0.518|TWO_SIDED|95.0|0.854|1.313|||Chi-squared|||||1.313|0.854|0.518
71695678|NCT03256578|142906643|SUPERIORITY||Risk Ratio (RR)|0.951||||0.855|TWO_SIDED|95.0|0.555|1.629|||Chi-squared|||||1.629|0.555|0.855
71695679|NCT03256578|142906644|SUPERIORITY||Risk Ratio (RR)|0.994||||0.524|TWO_SIDED|95.0|0.834|1.186|||Chi-squared|||||1.186|0.834|0.524
71695680|NCT03256578|142906645|SUPERIORITY||Risk Ratio (RR)|0.649||||0.28|TWO_SIDED|95.0|0.294|1.434|||Chi-squared|||||1.434|0.294|0.280
71695681|NCT03256578|142906646|SUPERIORITY||Risk Ratio (RR)|1.393||||0.339|TWO_SIDED|95.0|0.703|2.76|||Chi-squared|||||2.760|0.703|0.339
71695682|NCT03256578|142906647|SUPERIORITY|||||||0.486|||||||Chi-squared|||||||0.486
71695683|NCT03256578|142906648|SUPERIORITY|||||||0.655|||||||Chi-squared|||||||0.655
71695684|NCT03256578|142906649|SUPERIORITY||Risk Ratio (RR)|1.0||||1|TWO_SIDED|95.0|0.99|1.02|||Chi-squared|||||1.02|0.99|1.00
71943459|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|-0.001||||0.929|TWO_SIDED|95.0|-0.017|0.015||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.015|-0.017|0.929
71943460|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|-0.005||||0.543|TWO_SIDED|95.0|-0.02|0.01||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.01|-0.02|0.543
71943461|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|0.008||||0.752|TWO_SIDED|95.0|-0.043|0.059||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.059|-0.043|0.752
71943462|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|0.011||||0.691|TWO_SIDED|95.0|-0.042|0.064||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.042|0.691
71695685|NCT02371616|142906650|NON_INFERIORITY|Inferences: upper end of the 2-sided 95% CI for the treatment difference for the estimated effect of Test relative to Comparator, for success, should be \<=6mm. (i.e., Test is no more than 6mm inferior to Comparator).|Least square (LS) mean difference|2.67||||0.2678|TWO_SIDED|95.0|-2.06|7.4||From ANCOVA model: change from baseline as the response variable, treatment group, baseline Schiff stratum and study site as fixed effects, with baseline VAS score as covariate.|ANCOVA||Difference is first named treatment minus second named dentifrice such that a negative difference favors the first named treatment.|Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.||7.40|-2.06|0.2678
71695686|NCT02990000|142906654|SUPERIORITY|We used the Optimal Design program to determine the minimum numbers of therapists and patients needed to detect a moderate effect of condition (standardized difference between change rates = .50). Based on this a priori power analysis, we will need a total of 44 therapists and 211 patients to achieve a power of .80 to detect moderate condition effects. Factoring in a 25% dropout rate, enrolling 281 patients should provide sufficient statistical power.|condition effect on weekly change rate|-0.04|STANDARD_ERROR_OF_MEAN|0.01||0.02|TWO_SIDED|95.0|-0.05|-0.03|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the TOP-CS average z-scores. Given that higher TOP-CS z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.03|-0.05|.02
71695687|NCT02990000|142906655|SUPERIORITY||condition effect on weekly change rate|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.03|TWO_SIDED|95.0|-0.3|-0.02|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the SCL-10 total score. Given that higher SCL-10 scores indicate greater psychological distress, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.02|-0.30|.03
71695688|NCT02990000|142906656|SUPERIORITY||condition effect on weekly change rate|-0.07|STANDARD_ERROR_OF_MEAN|0.15||0.65|TWO_SIDED|95.0|-0.33|0.21|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the patient-rated WAI. Given that higher WAI scores indicate better quality therapeutic alliances, positive slopes indicate a weekly increase in alliance during treatment (i.e., a better outcome or more improvement).||0.21|-0.33|.65
71695689|NCT02990000|142906657|SUPERIORITY||condition effect on weekly change rate|-0.06|STANDARD_ERROR_OF_MEAN|0.07||0.41|TWO_SIDED|95.0|-0.17|0.07|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the OE subscale of the CEQ. Given that higher OE scores indicate more optimistic expectations, positive slopes indicate a weekly increase in OE during treatment (i.e., a better outcome or more improvement).||0.07|-0.17|.41
71695690|NCT02990000|142906658|SUPERIORITY||condition effect on weekly change rate|-0.01|STANDARD_ERROR_OF_MEAN|0.002||0.01|TWO_SIDED|95.0|-0.01|-0.006|||3-level hierarchical linear model|||To account for the nested nature of the data (time points nested within patients nested within therapists), a 3-level hierarchical linear model was used to test the effect of condition (Scientific Match = 1; Pragmatic Match = 0) on weekly during-treatment change on the log-transformed TOP-CS domain-specific z-scores. Given that higher z-scores indicate greater impairment, negative slopes indicate a weekly decrease in impairment during treatment (i.e., a better outcome or more improvement).||-0.006|-0.01|.01
71695691|NCT02990000|142906659|SUPERIORITY||Odds Ratio (OR)|1.3|STANDARD_ERROR_OF_MEAN|0.48||0.48|TWO_SIDED||||||Multilevel logistic regression|||Multilevel logistic regression analysis with patients nested within therapists (Scientific Match = 1; Pragmatic Match = 0). Statistically significant odds ratios that are greater than 1 would indicate that patients in the Scientific Match Condition were more likely to discontinue treatment early, whereas odds ratios that are less than 1 would indicate the opposite.||||.48
71695692|NCT02990000|142906660|SUPERIORITY||condition effect on satisfaction|0.37|STANDARD_ERROR_OF_MEAN|0.48||0.44|TWO_SIDED|95.0|-0.57|1.31|||2-level hierarchical linear model|||Due to the nested nature of the data (patients nested within therapists), we used a two-level hierarchical linear model to test the effect of condition on provider satisfaction at posttreatment. Because higher values indicate more satisfaction, a positive condition effect would indicate that Scientific Match patients were more satisfied than Pragmatic Match patients, whereas a negative condition effect would indicate the opposite.||1.31|-0.57|.44
71695693|NCT00754741|142906661|SUPERIORITY_OR_OTHER|||||||0.763|TWO_SIDED||||||ANOVA|||||||0.763
71695694|NCT00754741|142906661|SUPERIORITY_OR_OTHER|||||||0.285|TWO_SIDED||||||ANOVA|||||||0.285
71695695|NCT00754741|142906662|SUPERIORITY_OR_OTHER|||||||0.38|TWO_SIDED||||||ANOVA|||||||0.380
71695696|NCT00754741|142906662|SUPERIORITY_OR_OTHER|||||||0.084|TWO_SIDED||||||ANOVA|||||||0.084
71695697|NCT00754741|142906663|SUPERIORITY_OR_OTHER|||||||0.667|TWO_SIDED||||||ANOVA|||||||0.667
71695698|NCT00754741|142906663|SUPERIORITY_OR_OTHER|||||||0.53|TWO_SIDED||||||ANOVA|||||||0.530
71695699|NCT00754741|142906664|SUPERIORITY_OR_OTHER|||||||0.881|TWO_SIDED||||||ANOVA|||||||0.881
71695700|NCT00754741|142906664|SUPERIORITY_OR_OTHER|||||||0.849|TWO_SIDED||||||ANOVA|||||||0.849
71695701|NCT00754741|142906665|SUPERIORITY_OR_OTHER|||||||0.134|TWO_SIDED||||||Chi-squared|||||||0.134
71695702|NCT00754741|142906665|SUPERIORITY_OR_OTHER|||||||0.714|TWO_SIDED||||||Chi-squared|||||||0.714
71695703|NCT00754741|142906666|SUPERIORITY_OR_OTHER|||||||0.291|TWO_SIDED||||||ANOVA|||||||0.291
71695704|NCT00754741|142906666|SUPERIORITY_OR_OTHER|||||||0.968|TWO_SIDED||||||ANOVA|||||||0.968
71695705|NCT00754741|142906667|SUPERIORITY_OR_OTHER|||||||0.671|TWO_SIDED||||||ANOVA|||||||0.671
71695706|NCT00754741|142906667|SUPERIORITY_OR_OTHER|||||||0.399|TWO_SIDED||||||ANOVA|||||||0.399
71695707|NCT00754741|142906668|SUPERIORITY_OR_OTHER|||||||0.829|TWO_SIDED||||||ANOVA|||||||0.829
71695708|NCT00754741|142906668|SUPERIORITY_OR_OTHER|||||||0.283|TWO_SIDED||||||ANOVA|||||||0.283
71695709|NCT00754741|142906669|SUPERIORITY_OR_OTHER|||||||0.971|TWO_SIDED||||||ANOVA|||||||0.971
71695710|NCT00754741|142906669|SUPERIORITY_OR_OTHER|||||||0.115|TWO_SIDED||||||ANOVA|||||||0.115
71695711|NCT00754741|142906670|SUPERIORITY_OR_OTHER|||||||0.573|TWO_SIDED||||||ANOVA|||||||0.573
71695712|NCT00754741|142906670|SUPERIORITY_OR_OTHER|||||||0.443|TWO_SIDED||||||ANOVA|||||||0.443
71695713|NCT00754741|142906671|SUPERIORITY_OR_OTHER|||||||0.469|TWO_SIDED||||||ANOVA|||||||0.469
71695714|NCT00754741|142906671|SUPERIORITY_OR_OTHER|||||||0.369|TWO_SIDED||||||ANOVA|||||||0.369
71695715|NCT00754741|142906672|SUPERIORITY_OR_OTHER|||||||0.779|TWO_SIDED||||||ANOVA|||||||0.779
71695716|NCT00754741|142906672|SUPERIORITY_OR_OTHER|||||||0.733|TWO_SIDED||||||ANOVA|||||||0.733
71695717|NCT00754741|142906673|SUPERIORITY_OR_OTHER|||||||0.952|TWO_SIDED||||||ANOVA|||||||0.952
71695718|NCT00754741|142906673|SUPERIORITY_OR_OTHER|||||||0.856|TWO_SIDED||||||ANOVA|||||||0.856
71695719|NCT00754741|142906674|SUPERIORITY_OR_OTHER|||||||0.419|TWO_SIDED||||||Chi-squared|||||||0.419
71695720|NCT00754741|142906674|SUPERIORITY_OR_OTHER|||||||0.998|TWO_SIDED||||||Chi-squared|||||||0.998
71695721|NCT00922636|142906675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.74||||0.008||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.008
71695722|NCT00922636|142906675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.04||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.|||||0.006
71695723|NCT00922636|142906678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16||||0.938||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.938
71695724|NCT00922636|142906678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.44||||0.002||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.||||0.002
71695725|NCT03268343|142906750|SUPERIORITY||Geometric LS Mean Ratio (%)|74.71|||||TWO_SIDED|90.0|66.39|84.08|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||84.08|66.39|
71695726|NCT03268343|142906751|SUPERIORITY||Geometric LS Mean Ratio (%)|97.04|||||TWO_SIDED|90.0|94.2|99.98|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.98|94.20|
71695727|NCT03268343|142906752|SUPERIORITY||Median Difference (Final Values)|1.38|||<|0.0001|TWO_SIDED|95.0|0.5|2.25|||Wilcoxon Signed-Rank test||Hodges-Lehmann method|||2.25|0.50|< 0.0001
71695728|NCT03268343|142906753|SUPERIORITY||Geometric LS Mean Ratio (%)|96.52|||||TWO_SIDED|90.0|93.3|99.85|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||99.85|93.30|
71695729|NCT03268343|142906757|SUPERIORITY||Geometric LS Mean Ratio (%)|104.75|||||TWO_SIDED|95.0|98.97|110.87|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).|||110.87|98.97|
71695730|NCT03028142|142906764|OTHER||LS Means ratio|1.05||||0.0022|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0022
71695731|NCT03028142|142906764|OTHER||LS Means ratio|1.09|||<|0.0001|TWO_SIDED|95.0|1.05|1.12|||ANCOVA|||||1.12|1.05|<0.0001
71695732|NCT03028142|142906765|OTHER||LS Means ratio|1.03||||0.0988|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.0988
71695733|NCT03028142|142906765|OTHER||LS Means ratio|1.06||||0.0009|TWO_SIDED|95.0|1.02|1.09|||ANCOVA|||||1.09|1.02|0.0009
71695734|NCT03028142|142906766|OTHER||LS Means ratio|1.02||||0.2496|TWO_SIDED|95.0|0.98|1.06|||ANCOVA|||||1.06|0.98|0.2496
71695735|NCT03028142|142906766|OTHER||LS Means ratio|1.06||||0.0039|TWO_SIDED|95.0|1.02|1.1|||ANCOVA|||||1.1|1.02|0.0039
71695736|NCT03028142|142906767|OTHER||LS Means ratio|1.03||||0.1404|TWO_SIDED|95.0|0.99|1.06|||ANCOVA|||||1.06|0.99|0.1404
71695737|NCT03028142|142906767|OTHER||LS Means ratio|1.04||||0.0228|TWO_SIDED|95.0|1.01|1.08|||ANCOVA|||||1.08|1.01|0.0228
71695738|NCT01573000|142906790|SUPERIORITY_OR_OTHER||percentage of participants|50.0|||||TWO_SIDED|95.0|35.0|65.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||65|35|
71695739|NCT01573000|142906790|SUPERIORITY_OR_OTHER||percentage of participants|22.0|||||TWO_SIDED|95.0|9.0|36.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||36|9|
71695740|NCT01573000|142906791|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) before Crossover.|||32|0|
71695741|NCT01573000|142906791|SUPERIORITY_OR_OTHER||percentage of participants|79.0|||||TWO_SIDED|95.0|61.0|97.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) after Crossover.|||97|61|
71695742|NCT01573000|142906792|SUPERIORITY_OR_OTHER||percentage of participants|26.0|||||TWO_SIDED|95.0|13.0|39.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||39|13|
71943463|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|0.01||||0.71|TWO_SIDED|95.0|-0.041|0.06||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.06|-0.041|0.71
71943464|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|0.0||||0.965|TWO_SIDED|95.0|-0.019|0.02||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.02|-0.019|0.965
71943465|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|-0.002||||0.885|TWO_SIDED|95.0|-0.022|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.019|-0.022|0.885
71943466|NCT02087904|143408322|SUPERIORITY||LS Mean Difference|0.001||||0.887|TWO_SIDED|95.0|-0.018|0.021||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.021|-0.018|0.887
71943467|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.005||||0.619|TWO_SIDED|95.0|-0.024|0.014||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.014|-0.024|0.619
71943468|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.001||||0.952|TWO_SIDED|95.0|-0.02|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.019|-0.02|0.952
71943469|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.003||||0.765|TWO_SIDED|95.0|-0.022|0.016||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee||0.016|-0.022|0.765
71695743|NCT01573000|142906792|SUPERIORITY_OR_OTHER||percentage of participants|8.0|||||TWO_SIDED|95.0|0.0|17.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||17|0|
71695744|NCT01573000|142906793|SUPERIORITY_OR_OTHER|||||||0.012||95.0|||||Fisher Exact|||||||0.012
71943470|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.04||||0.258|TWO_SIDED|95.0|-0.11|0.03||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.03|-0.11|0.258
71943471|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|0.023||||0.535|TWO_SIDED|95.0|-0.049|0.094||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.094|-0.049|0.535
71943472|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.006||||0.866|TWO_SIDED|95.0|-0.076|0.064||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau||0.064|-0.076|0.866
71943473|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.012||||0.413|TWO_SIDED|95.0|-0.041|0.017||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.017|-0.041|0.413
71943474|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|0.012||||0.445|TWO_SIDED|95.0|-0.018|0.042||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.042|-0.018|0.445
71943475|NCT02087904|143408323|SUPERIORITY||LS Mean Difference|-0.003||||0.835|TWO_SIDED|95.0|-0.032|0.026||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau||0.026|-0.032|0.835
71943476|NCT02087904|143408324|SUPERIORITY||Response Rate Difference|7.0||||0.311|TWO_SIDED|95.0|-7.3|21.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||21.4|-7.3|0.311
71943477|NCT02087904|143408324|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
71943478|NCT02087904|143408324|SUPERIORITY||Response Rate Difference|5.5||||0.435|TWO_SIDED|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||19.9|-8.9|0.435
71943479|NCT02087904|143408325|SUPERIORITY||Response Rate Difference|2.4||||0.744|TWO_SIDED|95.0|-11.9|16.8||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||16.8|-11.9|0.744
71943480|NCT02087904|143408325|SUPERIORITY||Response Rate Difference|4.3||||0.581|TWO_SIDED|95.0|-10.1|18.7||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||18.7|-10.1|0.581
71943481|NCT02087904|143408325|SUPERIORITY||Response Rate Difference|10.4||||0.146|TWO_SIDED|95.0|-3.5|24.3||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||24.3|-3.5|0.146
71943482|NCT02087904|143408326|SUPERIORITY||Response Rate Difference|-1.3||||0.824|TWO_SIDED|95.0|-14.9|12.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||12.4|-14.9|0.824
71943483|NCT02087904|143408326|SUPERIORITY||Response Rate Difference|0.8||||0.964|TWO_SIDED|95.0|-12.8|14.5||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||14.5|-12.8|0.964
71943484|NCT02087904|143408326|SUPERIORITY||Response Rate Difference|2.1||||0.763|TWO_SIDED|95.0|-11.3|15.6||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel|||||15.6|-11.3|0.763
71943485|NCT01389102|143408333|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71695745|NCT01573000|142906794|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed complete response before Crossover.|||0|0|
71695746|NCT01573000|142906794|SUPERIORITY_OR_OTHER||percentage of participants|42.0|||||TWO_SIDED|95.0|20.0|64.0|||||The estimated value represents the percentage of participants with confirmed complete response after Crossover.|||64|20|
71943486|NCT01389102|143408333|SUPERIORITY_OR_OTHER|||||||0.0099||95.0|||||ANCOVA|||||||0.0099
71943487|NCT01389102|143408333|SUPERIORITY_OR_OTHER|||||||0.0004||95.0|||||ANCOVA|||||||0.0004
71943488|NCT01389102|143408334|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71943489|NCT01389102|143408334|SUPERIORITY_OR_OTHER|||||||0.0406||95.0|||||ANCOVA|||||||0.0406
71943490|NCT01389102|143408334|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||ANCOVA|||||||<0.0001
71943491|NCT00696020|143408405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.024|STANDARD_ERROR_OF_MEAN|0.027||0.3791|TWO_SIDED|95.0|-0.029|0.076||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.076|-0.029|0.3791
71943492|NCT00696020|143408405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.033|STANDARD_ERROR_OF_MEAN|0.027||0.2133|TWO_SIDED|95.0|-0.019|0.085||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.085|-0.019|0.2133
71943493|NCT00696020|143408405|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.057|STANDARD_ERROR_OF_MEAN|0.027||0.0337|TWO_SIDED|95.0|0.004|0.11||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.110|0.004|0.0337
71943494|NCT00696020|143408406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_ERROR_OF_MEAN|0.026||0.1163|TWO_SIDED|95.0|-0.01|0.093||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.093|-0.010|0.1163
71943495|NCT00696020|143408406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.026||0.0224|TWO_SIDED|95.0|0.009|0.111||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.111|0.009|0.0224
71943496|NCT00696020|143408406|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.055|STANDARD_ERROR_OF_MEAN|0.026||0.038|TWO_SIDED|95.0|0.003|0.107||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.107|0.003|0.0380
71943497|NCT00696020|143408407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.002|STANDARD_ERROR_OF_MEAN|0.047||0.9573|TWO_SIDED|95.0|-0.089|0.094|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.094|-0.089|0.9573
71943498|NCT00696020|143408407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.099|STANDARD_ERROR_OF_MEAN|0.046||0.0321|TWO_SIDED|95.0|0.009|0.189|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.009|0.0321
71943499|NCT00696020|143408407|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.117|STANDARD_ERROR_OF_MEAN|0.047||0.0125|TWO_SIDED|95.0|0.025|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.025|0.0125
71943500|NCT00696020|143408408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.085|STANDARD_ERROR_OF_MEAN|0.03||0.0052|TWO_SIDED|95.0|0.026|0.145|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.145|0.026|0.0052
71943501|NCT00696020|143408408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.079|STANDARD_ERROR_OF_MEAN|0.03||0.0086|TWO_SIDED|95.0|0.02|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|0.020|0.0086
71943502|NCT00696020|143408408|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.125|STANDARD_ERROR_OF_MEAN|0.03|<|0.0001|TWO_SIDED|95.0|0.066|0.185|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.185|0.066|<0.0001
71943503|NCT00696020|143408409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.116|STANDARD_ERROR_OF_MEAN|0.056||0.0384|TWO_SIDED|95.0|0.006|0.225|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.225|0.006|0.0384
71943504|NCT00696020|143408409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.184|STANDARD_ERROR_OF_MEAN|0.055||0.0009|TWO_SIDED|95.0|0.076|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.076|0.0009
71943505|NCT00696020|143408409|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.239|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.13|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.130|<0.0001
71943506|NCT00696020|143408410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.357|STANDARD_ERROR_OF_MEAN|6.76||0.001|TWO_SIDED|95.0|9.057|35.657|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.657|9.057|0.0010
71695747|NCT01573000|142906795|SUPERIORITY_OR_OTHER||percentage of participants|2.0|||||TWO_SIDED|95.0|0.0|7.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||7|0|
71943507|NCT00696020|143408410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.769|STANDARD_ERROR_OF_MEAN|6.687||0.0053|TWO_SIDED|95.0|5.613|31.924|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||31.924|5.613|0.0053
71943508|NCT00696020|143408410|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.954|STANDARD_ERROR_OF_MEAN|6.805|<|0.0001|TWO_SIDED|95.0|13.565|40.343|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||40.343|13.565|<0.0001
71943509|NCT00696020|143408411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.031||0.0048|TWO_SIDED|95.0|0.027|0.149|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.149|0.027|0.0048
71943510|NCT00696020|143408411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.086|STANDARD_ERROR_OF_MEAN|0.031||0.0056|TWO_SIDED|95.0|0.025|0.146|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.025|0.0056
71943511|NCT00696020|143408411|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128|STANDARD_ERROR_OF_MEAN|0.031|<|0.0001|TWO_SIDED|95.0|0.066|0.189|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.189|0.066|<0.0001
71943512|NCT00696020|143408412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.056||0.0332|TWO_SIDED|95.0|0.01|0.23|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.230|0.010|0.0332
71943513|NCT00696020|143408412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.183|STANDARD_ERROR_OF_MEAN|0.055||0.0011|TWO_SIDED|95.0|0.074|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.292|0.074|0.0011
71943514|NCT00696020|143408412|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.238|STANDARD_ERROR_OF_MEAN|0.056|<|0.0001|TWO_SIDED|95.0|0.128|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.349|0.128|<0.0001
71943515|NCT00696020|143408413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.867|STANDARD_ERROR_OF_MEAN|6.813||0.0009|TWO_SIDED|95.0|9.462|36.272|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||36.272|9.462|0.0009
71943516|NCT00696020|143408413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.743|STANDARD_ERROR_OF_MEAN|6.739||0.0036|TWO_SIDED|95.0|6.484|33.002|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||33.002|6.484|0.0036
71943517|NCT00696020|143408413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.793|STANDARD_ERROR_OF_MEAN|6.859|<|0.0001|TWO_SIDED|95.0|14.298|41.287|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||41.287|14.298|<0.0001
71943518|NCT00696020|143408414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088|STANDARD_ERROR_OF_MEAN|0.033||0.0079|TWO_SIDED|95.0|0.023|0.152|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.152|0.023|0.0079
71943519|NCT00696020|143408414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.082|STANDARD_ERROR_OF_MEAN|0.032||0.012|TWO_SIDED|95.0|0.018|0.146|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.146|0.018|0.0120
71943520|NCT00696020|143408414|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.144|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.08|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.209|0.080|<0.0001
71943521|NCT00696020|143408415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.131|STANDARD_ERROR_OF_MEAN|0.06||0.0296|TWO_SIDED|95.0|0.013|0.249|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.249|0.013|0.0296
71943522|NCT00696020|143408415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.204|STANDARD_ERROR_OF_MEAN|0.059||0.0007|TWO_SIDED|95.0|0.087|0.32|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.320|0.087|0.0007
71943523|NCT00696020|143408415|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.265|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|0.147|0.383|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.383|0.147|<0.0001
71943524|NCT00696020|143408416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.414|STANDARD_ERROR_OF_MEAN|7.057||0.001|TWO_SIDED|95.0|9.529|37.3|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||37.300|9.529|0.0010
71943525|NCT00696020|143408416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.695|STANDARD_ERROR_OF_MEAN|6.981||0.0078|TWO_SIDED|95.0|4.961|32.43|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||32.430|4.961|0.0078
71943526|NCT00696020|143408416|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.357|STANDARD_ERROR_OF_MEAN|7.105|<|0.0001|TWO_SIDED|95.0|15.379|43.335|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||43.335|15.379|<0.0001
71943527|NCT00696020|143408418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.044|STANDARD_ERROR_OF_MEAN|0.048||0.3517|TWO_SIDED|95.0|-0.049|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.138|-0.049|0.3517
71943528|NCT00696020|143408418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.048|STANDARD_ERROR_OF_MEAN|0.048||0.3171|TWO_SIDED|95.0|-0.046|0.143|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.143|-0.046|0.3171
71943529|NCT00696020|143408418|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.048||0.4654|TWO_SIDED|95.0|-0.06|0.13|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||0.130|-0.060|0.4654
71943530|NCT00696020|143408419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.106|STANDARD_ERROR_OF_MEAN|7.704||0.0899|TWO_SIDED|95.0|-2.055|28.267|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||28.267|-2.055|0.0899
71943531|NCT00696020|143408419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.817|STANDARD_ERROR_OF_MEAN|7.759||0.0111|TWO_SIDED|95.0|4.549|35.084|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||35.084|4.549|0.0111
71943532|NCT00696020|143408419|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.893|STANDARD_ERROR_OF_MEAN|7.844||0.0166|TWO_SIDED|95.0|3.458|34.329|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.|||34.329|3.458|0.0166
71943533|NCT01387022|143408432|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.00
71695748|NCT01573000|142906795|SUPERIORITY_OR_OTHER||percentage of participants|3.0|||||TWO_SIDED|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||8|0|
71943534|NCT01387022|143408433|SUPERIORITY_OR_OTHER|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||||||0.481
71943535|NCT01387022|143408435|SUPERIORITY_OR_OTHER|||||||0.267|||||||Fisher Exact|||||||0.267
71943536|NCT01536405|143408446|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease \>= the prespecified criterion of 10 percentage points|Risk Difference (RD)|4.2|||<|0.001|TWO_SIDED|95.0|1.8|6.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||6.8|1.8|<0.001
71943537|NCT01536405|143408446|SUPERIORITY_OR_OTHER||Response rate|97.3|||<|0.001|TWO_SIDED|95.0|95.6|98.4|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>76%||98.4|95.6|<0.001
71943538|NCT01536405|143408447|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-2.2||||0.003|TWO_SIDED|95.0|-4.0|-0.6|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||-0.6|-4.0|0.003
71695749|NCT01573000|142906796|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CCR before Crossover.|||0|0|
71943539|NCT01536405|143408447|SUPERIORITY_OR_OTHER||Response rate|96.7|||<|0.001|TWO_SIDED|95.0|94.9|97.9|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||97.9|94.9|<0.001
71943540|NCT01536405|143408448|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|1.0|||<|0.001|TWO_SIDED|95.0|-0.7|2.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||2.8|-0.7|<0.001
71943541|NCT01536405|143408448|SUPERIORITY_OR_OTHER||Response rate|98.2|||<|0.001|TWO_SIDED|95.0|96.8|99.1|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.1|96.8|<0.001
71695750|NCT01573000|142906796|SUPERIORITY_OR_OTHER||percentage of participants|5.0|||||TWO_SIDED|95.0|0.0|15.0|||||The estimated value represents the percentage of participants with confirmed CCR after Crossover.|||15|0|
71695751|NCT01573000|142906797|SUPERIORITY_OR_OTHER||percentage of participants|31.0|||||TWO_SIDED|95.0|17.0|45.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||45|17|
71943542|NCT01536405|143408449|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease \>= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-0.5|||<|0.001|TWO_SIDED|95.0|-1.8|0.7|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||0.7|-1.8|<0.001
71943543|NCT01536405|143408449|SUPERIORITY_OR_OTHER||Response rate|98.8|||<|0.001|TWO_SIDED|95.0|97.6|99.5|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being \>90%||99.5|97.6|<0.001
71943544|NCT01536405|143408450|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.2|||<|0.001|TWO_SIDED|95.0|1.1|1.3|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.3|1.1|<0.001
71943545|NCT01536405|143408451|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|0.9|||<|0.001|TWO_SIDED|95.0|0.8|1.0|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.0|0.8|<0.001
71943546|NCT01536405|143408452|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
71943547|NCT01536405|143408453|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of \>=1.5 fold|GMT ratio|1.0|||<|0.001|TWO_SIDED|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)|||1.1|0.9|<0.001
71943548|NCT01536405|143408454|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.2|||<|0.001|TWO_SIDED|95.0|-1.0|1.3|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)|||1.3|-1.0|<0.001
71943549|NCT02495467|143408471|SUPERIORITY||Mean Difference (Final Values)|1.03||||0.0132|TWO_SIDED|95.0|0.22|1.84|||Mixed Models Analysis|||||1.84|0.22|0.0132
71695752|NCT01573000|142906797|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
71943550|NCT02495467|143408472|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0122|TWO_SIDED|95.0|0.09|0.73|||Mixed Models Analysis|||||0.73|0.09|0.0122
71943551|NCT02495467|143408473|SUPERIORITY||Mean Difference (Final Values)|0.39|||<|0.0001|TWO_SIDED|95.0|0.21|0.57|||Mixed Models Analysis|||||0.57|0.21|<0.0001
71943552|NCT02495467|143408474|SUPERIORITY||Mean Difference (Final Values)|0.41||||0.0055|TWO_SIDED|95.0|0.12|0.69|||Mixed Models Analysis|||||0.69|0.12|0.0055
71943553|NCT02495467|143408475|SUPERIORITY||Mean Difference (Final Values)|0.48||||0.001|TWO_SIDED|95.0|0.2|0.76|||Mixed Models Analysis|||||0.76|0.20|0.001
71695753|NCT01573000|142906798|SUPERIORITY_OR_OTHER||percentage of participants|0.0|||||TWO_SIDED|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR before Crossover.|||0|0|
71695754|NCT01573000|142906798|SUPERIORITY_OR_OTHER||percentage of participants|47.0|||||TWO_SIDED|95.0|25.0|70.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR after Crossover.|||70|25|
71943554|NCT02495467|143408476|SUPERIORITY||Means ratio|0.995||||0.7999|TWO_SIDED|95.0|0.96|1.032|||Generalized Linear Mixed Model|||||1.032|0.960|0.7999
71943555|NCT02495467|143408477|SUPERIORITY||Means ratio|0.989||||0.6746|TWO_SIDED|95.0|0.937|1.043|||Generalized Linear Mixed Model|||||1.043|0.937|0.6746
71943556|NCT02495467|143408478|SUPERIORITY||Means ratio|1.075||||0.0959|TWO_SIDED|95.0|0.987|1.17|||Generalized Linear Mixed Model|||||1.170|0.987|0.0959
71943557|NCT02495467|143408479|SUPERIORITY||Means ratio|1.522|||<|0.0001|TWO_SIDED|95.0|1.267|1.829|||Generalized Linear Mixed Model|||||1.829|1.267|<0.0001
71943558|NCT02495467|143408480|SUPERIORITY||Means ratio|1.32||||0.0005|TWO_SIDED|95.0|1.128|1.545|||Generalized Linear Mixed Model|||||1.545|1.128|0.0005
71943559|NCT02495467|143408481|SUPERIORITY||||||<|0.0001|||||||Prescott Test (Exact)|||||||<0.0001
71943560|NCT02495467|143408482|SUPERIORITY|||||||0.0003|||||||Prescott Test (Exact)|||||||0.0003
71943561|NCT02193165|143408493|SUPERIORITY_OR_OTHER|||||||0.434|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p\<0.5||||0.434
71943562|NCT02193165|143408494|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P\<0.05||||<0.001
71695755|NCT01573000|142906799|SUPERIORITY_OR_OTHER||percentage of participants|17.0|||||TWO_SIDED|95.0|5.0|28.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.|||28|5|
71695756|NCT01573000|142906799|SUPERIORITY_OR_OTHER||percentage of participants|11.0|||||TWO_SIDED|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.|||21|1|
71695757|NCT01573000|142906800|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Fisher Exact|||||||0.001
71695758|NCT01573000|142906802|SUPERIORITY_OR_OTHER|||||||0.495||95.0|||||Log Rank|||||||0.495
71695759|NCT01573000|142906803|SUPERIORITY_OR_OTHER|||||||0.677||95.0|||||Log Rank|||||||0.677
71695760|NCT01573000|142906806|SUPERIORITY_OR_OTHER|||||||0.119||95.0|||||Log Rank|||||||0.119
71695761|NCT01573000|142906807|SUPERIORITY_OR_OTHER|||||||0.016||95.0|||||Log Rank|||||||0.016
71695762|NCT01573000|142906820|SUPERIORITY_OR_OTHER||percentage of participants|16.0|||||TWO_SIDED|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed PR before Crossover.|||32|0|
71695763|NCT01573000|142906820|SUPERIORITY_OR_OTHER||percentage of participants|32.0|||||TWO_SIDED|95.0|11.0|52.0|||||The estimated value represents the percentage of participants with confirmed PR after Crossover.|||52|11|
71695764|NCT02351934|142906846|SUPERIORITY|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.564
71695765|NCT02351934|142906847|SUPERIORITY|||||||0.675|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.675
71695766|NCT02351934|142906848|SUPERIORITY|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.125
71695767|NCT02351934|142906850|SUPERIORITY|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.595
71695768|NCT02351934|142906851|SUPERIORITY|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.||||0.985
71943563|NCT02193165|143408495|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P\<0.05||||<0.001
71943564|NCT02193165|143408496|SUPERIORITY_OR_OTHER|||||||0.816|TWO_SIDED||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P\<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different||||0.816
71695769|NCT01115452|142906852|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.32||||0.9347|TWO_SIDED|95.0|-8.14|7.5||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis was no difference between treatments.||7.50|-8.14|0.9347
71695770|NCT01115452|142906853|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.02||||0.9963|TWO_SIDED|95.0|-8.2|8.24||Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.24|-8.20|0.9963
71695771|NCT01115452|142906853|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.9||||0.3582|TWO_SIDED|95.0|-4.45|12.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.25|-4.45|0.3582
71695772|NCT01115452|142906853|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.88||||0.36|TWO_SIDED|95.0|-4.46|12.22||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.22|-4.46|0.3600
71695773|NCT01115452|142906854|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.91||||0.8265|TWO_SIDED|95.0|-9.13|7.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.30|-9.13|0.8265
71695774|NCT01115452|142906854|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.9||||0.8314|TWO_SIDED|95.0|-9.25|7.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.45|-9.25|0.8314
71695775|NCT01115452|142906854|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.01||||0.9978|TWO_SIDED|95.0|-8.33|8.35||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.35|-8.33|0.9978
71695776|NCT01115452|142906855|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.22||||0.3122|TWO_SIDED|95.0|-4.0|12.44|||ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.44|-4.00|0.3122
71695777|NCT01115452|142906855|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.27||||0.7646|TWO_SIDED|95.0|-9.62|7.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.08|-9.62|0.7646
71943565|NCT02193165|143408497|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
71695778|NCT01115452|142906855|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.49||||0.1957||95.0|-13.83|2.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.85|-13.83|0.1957
71695779|NCT01115452|142906856|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.35||||0.7472|TWO_SIDED|95.0|-9.62|6.92||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.92|-9.62|0.7472
71695780|NCT01115452|142906856|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.66||||0.8767||95.0|-7.75|9.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.08|-7.75|0.8767
71695781|NCT01115452|142906856|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.01||||0.6367||95.0|-6.39|10.42||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.42|-6.39|0.6367
71695782|NCT01115452|142906857|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.95||||0.6417|TWO_SIDED|95.0|-10.22|6.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.32|-10.22|0.6417
71695783|NCT01115452|142906857|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.43||||0.92|TWO_SIDED|95.0|-7.99|8.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.85|-7.99|0.9200
71695784|NCT01115452|142906857|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.38||||0.5766||95.0|-6.02|10.78||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.78|-6.02|0.5766
71695785|NCT01115452|142906858|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.58||||0.393|TWO_SIDED|95.0|-11.65|4.68||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.68|-11.65|0.3930
71695786|NCT01115452|142906858|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.7||||0.6896|TWO_SIDED|95.0|-10.12|6.71||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.71|-10.12|0.6896
71695787|NCT01115452|142906858|SUPERIORITY_OR_OTHER||Adjustes mean difference|1.88||||0.6591|TWO_SIDED|95.0|-6.52|10.28||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.28|-6.52|0.6591
71695788|NCT01115452|142906859|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.08||||0.6301||95.0|-10.6|6.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.45|-10.60|0.6301
71695789|NCT01115452|142906859|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.76||||0.6888|TWO_SIDED|95.0|-10.46|6.93||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.93|-10.46|0.6888
71695790|NCT01115452|142906859|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.32||||0.9428|TWO_SIDED|95.0|-8.37|9.0||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.00|-8.37|0.9428
71695791|NCT01115452|142906860|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.58||||0.5504|TWO_SIDED|95.0|-11.1|5.95||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.95|-11.10|0.5504
71695792|NCT01115452|142906860|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.1||||0.634|TWO_SIDED|95.0|-10.8|6.6||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.60|-10.80|0.6340
71695793|NCT01115452|142906860|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.48||||0.9127|TWO_SIDED|95.0|-8.2|9.16|||ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.16|-8.20|0.9127
71695794|NCT01115452|142906861|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.15||||0.6192|TWO_SIDED|95.0|-10.67|6.38||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.38|-10.67|0.6192
71695795|NCT01115452|142906861|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.6||||0.8912|TWO_SIDED|95.0|-8.1|9.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.30|-8.10|0.8912
71695796|NCT01115452|142906861|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.75||||0.5321|TWO_SIDED|95.0|-5.93|11.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution|Null hypothesis is no difference between treatments.||11.43|-5.93|0.5321
71695797|NCT01115452|142906862|SUPERIORITY_OR_OTHER||Adjusted mean difference|-3.37||||0.4055|TWO_SIDED|95.0|-11.37|4.63||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||4.63|-11.37|0.4055
71695798|NCT01115452|142906862|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.74||||0.8573|TWO_SIDED|95.0|-7.42|8.91||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.91|-7.42|0.8573
71695799|NCT01115452|142906862|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.12||||0.3193|TWO_SIDED|95.0|-4.03|12.27||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.27|-4.03|0.3193
71943566|NCT02193165|143408498|SUPERIORITY_OR_OTHER||||||<|0.001|TWO_SIDED|95.0||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P\<0.05||||<0.001
71943567|NCT00678639|143408502|SUPERIORITY_OR_OTHER||Median cost difference|588.0|||||TWO_SIDED|95.0|336.0|811.0|||Hodges-Lehmann (median cost difference)|Distribution-free 95% CIs calculated using the method of Moses.|Results favored a reduced cost in the OU-CMR group.|H0: The median costs are not different among the study groups. HA: The median cost is different among groups. Power calculation was based on detecting a mean cost difference of $2000. Data was found to be non-normally distributed and therefore nonparametric comparisons were implemented.||811|336|
71943568|NCT00678639|143408503|SUPERIORITY_OR_OTHER||||||<|0.001||95.0|||||Fisher Exact|||"H0: There is no difference in correct cardiovascular admission decisions among groups.~Ha: A difference exists among study groups. Sample size was based upon 47 analyzable participants per study arm were required to provide 88% power to detect a 30% difference in the outcome."||||<0.001
71943569|NCT03611608|143408507|SUPERIORITY||Mean Difference (Final Values)|263.54|||<|0.001|ONE_SIDED|90.0|207.86||||t-test, 1 sided||||||207.86|<0.001
71943570|NCT00986245|143408511|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.4|||<|0.05|||||||Sign test|||The UPDRS-part3 was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
71943571|NCT00986245|143408512|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.0|||<|0.05|||||||Sign test|||The Hoehn and Yahr stage was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.||||<0.05
71943572|NCT00986245|143408513|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.3|||<|0.05|||||||Sign test|||"The Overall quality of sleep was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
71943573|NCT00986245|143408514|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Net)|0.2|||<|0.05|||||||Sign test|||"The Nocturnal off-symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
71943574|NCT00986245|143408515|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4|||<|0.05||||||80% power|Sign test|||"The Early morning off symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
71943575|NCT00986245|143408516|NON_INFERIORITY_OR_EQUIVALENCE|80% power|Mean Difference (Final Values)|0.1|||<|0.05|||||||Sign test|||"The Epworth sleep scale was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."||||<0.05
71943576|NCT00986245|143408517|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.8|||<|0.05|||||||Sign test|||||||<0.05
71943577|NCT01214850|143408524|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.185||||0.3828|TWO_SIDED|95.0|0.809|1.737|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination||1.737|0.809|0.3828
71943578|NCT01214850|143408525|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.84|||||TWO_SIDED|95.0|0.555|1.273|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine||1.273|0.555|
71943579|NCT00854308|143408562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.086||||0.6873|TWO_SIDED|95.0|0.727|1.622|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, Eastern Cooperative Oncology Group (ECOG) performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||1.622|0.727|0.6873
71943580|NCT00854308|143408563|SUPERIORITY_OR_OTHER|||||||0.7101||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.||||0.7101
71943581|NCT00854308|143408564|SUPERIORITY_OR_OTHER|||||||0.3671||95.0||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib||||0.3671
71943582|NCT00854308|143408565|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.529||||0.0418|TWO_SIDED|95.0|0.284|0.986|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, ECOG performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.||0.986|0.284|0.0418
71943583|NCT03252353|143408644|SUPERIORITY|||||||0.0079|||||||Regression, Logistic|The adjusted proportion of responders is 58.16 for Octreotide Capsule Treatment Group vs. 19.42 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0079
71943584|NCT03252353|143408645|SUPERIORITY|||||||0.0007|||||||Regression, Logistic|The adjusted proportion of responders is 77.66 for Octreotide Capsule Treatment Group vs. 30.40 for the Placebo||The proportion of \[IGF-1/GH\] responders was compared between treatment groups using an exact logistic regression model with categorical covariates for treatment group, prior SRL dose, and baseline \[IGF-1/GH\] level||||0.0007
71943585|NCT03252353|143408646|SUPERIORITY|||||||0.0029|||||||Fisher Exact|||||||0.0029
71943586|NCT00048581|143408647|SUPERIORITY_OR_OTHER||Est. Weighted. Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.6|41.1||The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be \~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||41.1|20.6|<0.001
71943587|NCT00048581|143408648|SUPERIORITY_OR_OTHER||Est. of Weighted Diff: Day 169 HAQ|24.0|||<|0.001|TWO_SIDED|95.0|13.8|34.2||If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.|The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||34.2|13.8|<0.001
71943588|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 20|12.3||||0.001|TWO_SIDED|95.0|4.6|20.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||20.0|4.6|0.001
71943589|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 50|2.3||||0.001|TWO_SIDED|95.0|-0.8|5.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||5.5|-0.8|0.001
71943590|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 15 ACR 70|0.8||||0.784|TWO_SIDED|95.0|-1.3|2.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||2.9|-1.3|0.784
71761154|NCT01262989|143023958|NON_INFERIORITY_OR_EQUIVALENCE|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.47||||||90.0|87.59|101.9|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.|||101.90|87.59|
71695800|NCT01115452|142906863|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.23||||0.4264||95.0|-4.77|11.23||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||11.23|-4.77|0.4264
71695801|NCT01115452|142906863|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.04||||0.8008|TWO_SIDED|95.0|-7.42|9.21||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.||9.21|-7.42|0.8008
71695802|NCT01115452|142906863|SUPERIORITY_OR_OTHER||Adjusted mean difference|-2.18||||0.5969|TWO_SIDED|95.0|-10.33|5.97||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||5.97|-10.33|0.5969
71695803|NCT01115452|142906864|SUPERIORITY_OR_OTHER||Adjusted mean difference|-5.14||||0.2059|TWO_SIDED|95.0|-13.14|2.86||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||2.86|-13.14|0.2059
71695804|NCT01115452|142906864|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.39||||0.9248|TWO_SIDED|95.0|-8.56|7.77||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.77|-8.56|0.9248
71695805|NCT01115452|142906864|SUPERIORITY_OR_OTHER||Adjusted mean difference|4.75||||0.2508|TWO_SIDED|95.0|-3.4|12.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||12.90|-3.40|0.2508
71695806|NCT01115452|142906865|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.12||||0.7822|TWO_SIDED|95.0|-6.86|9.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.10|-6.86|0.7822
71695807|NCT01115452|142906865|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.44||||0.7208|TWO_SIDED|95.0|-6.52|9.41||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.41|-6.52|0.7208
71695808|NCT01115452|142906866|SUPERIORITY_OR_OTHER||Adjusted mean difference|-1.36||||0.7318|TWO_SIDED|95.0|-9.18|6.46||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||6.46|-9.18|0.7318
71695809|NCT01115452|142906866|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.05||||0.7949|TWO_SIDED|95.0|-6.93|9.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||9.03|-6.93|0.7949
71695810|NCT01115452|142906866|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.41||||0.5507|TWO_SIDED|95.0|-5.56|10.37||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||10.37|-5.56|0.5507
71695811|NCT01115452|142906867|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.72||||0.8549|TWO_SIDED|95.0|-8.54|7.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period|Null hypothesis is no difference between treatments.||7.10|-8.54|0.8549
71761155|NCT02023697|143023995|OTHER||Hazard Ratio (HR)|1.057||||0.7047|TWO_SIDED|80.0|0.878|1.272|||Log Rank||Arm B / Arm (A+C)|||1.272|0.878|0.7047
71943591|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 20|14.0||||0.005|TWO_SIDED|95.0|4.0|24.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||24.0|4.0|0.005
71943592|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 50|5.6||||0.06|TWO_SIDED|95.0|-0.2|11.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||11.4|-0.2|0.06
71943593|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 29 ACR 70|1.6||||0.473|TWO_SIDED|95.0|-1.8|4.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||4.9|-1.8|0.473
71943594|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 20|22.0|||<|0.001|TWO_SIDED|95.0|11.3|32.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||32.8|11.3|<0.001
71943595|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 50|6.5||||0.076|TWO_SIDED|95.0|-0.6|13.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.7|-0.6|0.076
71943596|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 57 ACR 70|5.1||||0.019|TWO_SIDED|95.0|0.7|9.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.4|0.7|0.019
71943597|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 20|28.0|||<|0.001|TWO_SIDED|95.0|17.4|38.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||38.7|17.4|<0.001
71943598|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 50|12.0||||0.002|TWO_SIDED|95.0|4.1|19.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||19.8|4.1|0.002
71943599|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 85 ACR 70|5.1||||0.033|TWO_SIDED|95.0|0.4|9.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||9.8|0.4|0.033
71943600|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 20|25.9|||<|0.001|TWO_SIDED|95.0|15.1|36.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||36.8|15.1|<0.001
71943601|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 50|14.2|||<|0.001|TWO_SIDED|95.0|6.6|21.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||21.9|6.6|<0.001
71943602|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 113 ACR 70|7.8||||0.002|TWO_SIDED|95.0|2.6|13.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||13.0|2.6|0.002
71943603|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 20|35.5|||<|0.001|TWO_SIDED|95.0|24.6|46.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||46.5|24.6|<0.001
71943604|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 50|20.9|||<|0.001|TWO_SIDED|95.0|12.2|29.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||29.5|12.2|<0.001
71943605|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 141 ACR 70|10.2|||<|0.001|TWO_SIDED|95.0|4.4|16.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||16.0|4.4|<0.001
71943606|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 20|30.8|||<|0.001|TWO_SIDED|95.0|20.0|41.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).||41.7|20.0|<0.001
71943607|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 50|16.6|||<|0.001|TWO_SIDED|95.0|8.6|24.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||24.5|8.6|<0.001
71943608|NCT00048581|143408649|SUPERIORITY_OR_OTHER||Est. of Diff: Day 169 ACR 70|8.7||||0.003|TWO_SIDED|95.0|2.7|14.6|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).||14.6|2.7|0.003
71943609|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 PCS|3.63|||<|0.001|TWO_SIDED|95.0|1.89|5.38|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.38|1.89|<0.001
71943610|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 MCS|2.57||||0.017|TWO_SIDED|95.0|0.47|4.67|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.67|0.47|0.017
71943611|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Physical Function|1.7||||0.052|TWO_SIDED|95.0|-0.01|3.41|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.41|-0.01|0.052
71943612|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role-Physical|3.01||||0.007|TWO_SIDED|95.0|0.83|5.19|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.19|0.83|0.007
71943613|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Bodily Pain|5.62|||<|0.001|TWO_SIDED|95.0|3.77|7.47|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.47|3.77|<0.001
71943614|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: General Health|2.51||||0.001|TWO_SIDED|95.0|0.99|4.02|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.02|0.99|0.001
71943615|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Vitality|3.17||||0.001|TWO_SIDED|95.0|1.24|5.1|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.10|1.24|0.001
71943616|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Social Functioning|4.69|||<|0.001|TWO_SIDED|95.0|2.59|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.59|<0.001
71943617|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Role Emotional|0.97||||0.494|TWO_SIDED|95.0|-1.82|3.77|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||3.77|-1.82|0.494
71695812|NCT01115452|142906867|SUPERIORITY_OR_OTHER||Adjusted mean difference|-0.15||||0.9705|TWO_SIDED|95.0|-8.13|7.83||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||7.83|-8.13|0.9705
71695813|NCT01115452|142906867|SUPERIORITY_OR_OTHER||Adjusted mean difference|0.57||||0.8867|TWO_SIDED|95.0|-7.39|8.54||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.||8.54|-7.39|0.8867
71695814|NCT03843372|142906877|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The AHI was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare AHI between CPAP and HFNC||||<0.001
71695815|NCT03843372|142906878|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The oxygen desaturation index was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare oxygen desaturation index between CPAP and HFNC||||<0.001
71695816|NCT03843372|142906879|SUPERIORITY||||||<|0.001|||||||Wilcoxon rank sum test|||The total sleep time was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare total sleep time between CPAP and HFNC||||<0.001
71695817|NCT03843372|142906880|SUPERIORITY|||||||0.008|||||||Wilcoxon rank sum test|||The sleep efficiency was not a normal distribution. In the event that no carry over effect was detected between interventions, a Wilcoxon rank sum test was to be used to compare sleep efficiency between CPAP and HFNC||||0.008
71943618|NCT00048581|143408670|SUPERIORITY_OR_OTHER||Adj Diff: Day 85 Mental Health|2.59||||0.009|TWO_SIDED|95.0|0.65|4.54|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.54|0.65|0.009
71695818|NCT03238417|142906886|NON_INFERIORITY|Analysis of Variance comparing change in outcome between EBQI and control from baseline to 12 month.|Mean Difference (Net)|-0.65|STANDARD_ERROR_OF_MEAN|1.32||0.623|TWO_SIDED|95.0|-3.3|2.0||P-value is from the interaction term between EBQI and time.|ANOVA|||||2.0|-3.3|0.623
71695819|NCT03238417|142906887|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control from baseline to 24 months.|Mean Difference (Net)|-0.48|STANDARD_ERROR_OF_MEAN|1.1||0.678|TWO_SIDED|95.0|-2.8|1.8||P-value is from the interaction term of EBQI and time.|ANOVA|||||1.8|-2.8|0.678
71695820|NCT03238417|142906888|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.13||0.364|TWO_SIDED|95.0|-0.17|0.35||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 12-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 12-month||0.35|-0.17|0.364
71695821|NCT03238417|142906889|SUPERIORITY|Difference-in-differences analysis using linear regression, adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We adjusted our analysis with non-response weights.|Mean Difference (Final Values)|-0.11|STANDARD_ERROR_OF_MEAN|0.1||0.29|TWO_SIDED|95.0|-0.33|0.1||P-value reflects the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Linear||The estimated value reported here is the predicted mean change from baseline to 24-month, adjusting for characteristics described in the statistical analysis overview.|Change in gender awareness score between EBQI and control from baseline to 24-month||0.10|-0.33|0.29
71761156|NCT02023697|143023997|OTHER||Hazard Ratio (HR)|1.26||||0.3134|TWO_SIDED|80.0|0.939|1.69|||Log Rank||Arm C /Arm A|||1.690|0.939|0.3134
71761157|NCT02023697|143024001|OTHER||Hazard Ratio (HR)|1.075||||0.6205|TWO_SIDED|80.0|0.892|1.297|||Log Rank||Arm B/Arm (A+C)|||1.297|0.892|0.6205
71761158|NCT02023697|143024003|OTHER||Hazard Ratio (HR)|0.999||||0.9958|TWO_SIDED|80.0|0.744|1.341|||Log Rank||Arm C/Arm A|||1.341|0.744|0.9958
71761159|NCT02023697|143024007|OTHER||Hazard Ratio (HR)|1.068||||0.7461|TWO_SIDED|80.0|0.823|1.385|||Log Rank||Arm B/Arm (A+C)|||1.385|0.823|0.7461
71761160|NCT02023697|143024009|OTHER||Hazard Ratio (HR)|1.549||||0.155|TWO_SIDED|80.0|1.041|2.306|||Log Rank||Arm C/Arm A|||2.306|1.041|0.1550
71695822|NCT03238417|142906890|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.69|STANDARD_ERROR_OF_MEAN|0.42||0.1|TWO_SIDED|95.0|-1.52|0.13||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Difference-in-Differences analysis||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.13|-1.52|0.10
71943619|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 PCS|5.46|||<|0.001|TWO_SIDED|95.0|3.64|7.29|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.29|3.64|<0.001
71943620|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 MCS|3.04||||0.005|TWO_SIDED|95.0|0.91|5.17|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.17|0.91|0.005
71943621|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Physical Function|4.03|||<|0.001|TWO_SIDED|95.0|2.08|5.98|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||5.98|2.08|<0.001
71943622|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role-Physical|5.22|||<|0.001|TWO_SIDED|95.0|3.1|7.35|||ANCOVA|||||7.35|3.10|<0.001
71943623|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Bodily Pain|6.24|||<|0.001|TWO_SIDED|95.0|4.37|8.11|||ANCOVA|||||8.11|4.37|<0.001
71943624|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 General Health|3.27|||<|0.001|TWO_SIDED|95.0|1.64|4.9|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.90|1.64|<0.001
71943625|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Vitality|4.78|||<|0.001|TWO_SIDED|95.0|2.76|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.79|2.76|<0.001
71943626|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Social Functioning|4.92|||<|0.001|TWO_SIDED|95.0|2.71|7.12|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||7.12|2.71|<0.001
71695823|NCT03238417|142906891|SUPERIORITY|Difference-in-differences analysis using logistic regression. The number of activities were recoded into 0 vs 1+ activities. The model was adjusted for age, how often they saw women patients in the past year, location of practice in primary care or women's health clinic, and having had any type of quality improvement training. We also adjusted for non-response weights.|Odds Ratio (OR)|-0.48|STANDARD_ERROR_OF_MEAN|0.39||0.22|TWO_SIDED|95.0|-1.25|0.29||P-value is from the interaction term between EBQI and time, adjusted for non-response weights and characteristics described in the statistical analysis overview.|Regression, Logistic||The estimated value is predicted change in the odds of involving in one or more quality improvement activities, adjusting for characteristics described in the statistical analysis overview.|||0.29|-1.25|0.22
71695824|NCT03238417|142906892|NON_INFERIORITY|Analysis of Variance testing the differences in outcome between EBQI and control groups over 12 month period.|Mean Difference (Net)|-0.08|STANDARD_ERROR_OF_MEAN|3.1||0.788|TWO_SIDED|95.0|-7.1|5.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||5.4|-7.1|0.788
71943627|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Day 169 Role Emotional|3.54||||0.013|TWO_SIDED|95.0|0.74|6.33|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||6.33|0.74|0.013
71943628|NCT00048581|143408672|SUPERIORITY_OR_OTHER||Adj Diff: Mental Health|2.7||||0.006|TWO_SIDED|95.0|0.79|4.6|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.||4.60|0.79|0.006
71943629|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: HAQ-DI|-0.34|||<|0.001|TWO_SIDED|95.0|-0.44|-0.23|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.23|-0.44|<0.001
71761161|NCT02023697|143024013|OTHER||Hazard Ratio (HR)|0.969||||0.8284|TWO_SIDED|80.0|0.805|1.167|||Log Rank||Arm B/Arm (A+C)|||1.167|0.805|0.8284
71695825|NCT03238417|142906893|NON_INFERIORITY|Analysis of Variance testing for differences in outcomes between EBQI and control arms from baseline to 24 months.|Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|2.89||0.61|TWO_SIDED|95.0|-7.35|4.35||The p-value reflects the interaction terms between EBQI and control arms.|ANOVA|||||4.35|-7.35|0.61
71695826|NCT03238417|142906894|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|-0.17|STANDARD_ERROR_OF_MEAN|10.5||0.987|TWO_SIDED|95.0|-21.45|21.11||The p-value reflects the interaction term between EBQI and time|ANOVA|||||21.11|-21.45|0.987
71695827|NCT03238417|142906895|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-3.91|STANDARD_ERROR_OF_MEAN|10.35||0.708|TWO_SIDED|95.0|-24.89|17.08||The p-value reflects the interaction terms between EBQI and time|ANOVA|||||17.08|-24.89|0.708
71695828|NCT03238417|142906896|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|-4.51|STANDARD_ERROR_OF_MEAN|8.85||0.613|TWO_SIDED|95.0|-22.43|13.4||The p-value reflects the interaction term between EBQI and time|ANOVA|||||13.40|-22.43|0.613
71695829|NCT03238417|142906897|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control groups|Mean Difference (Net)|0.94|STANDARD_ERROR_OF_MEAN|9.48||0.922|TWO_SIDED|95.0|-18.26|20.13||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||20.13|-18.26|0.922
71695830|NCT03238417|142906898|NON_INFERIORITY|two-way ANOVA testing change in a composite score of gender-neutral preventive care between EBQI and control arms over time|Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|2.13||0.789|TWO_SIDED|95.0|-3.74|4.89||The p-value represents the interaction term between EBQI and control.|ANOVA|||||4.89|-3.74|0.789
71695831|NCT03238417|142906899|NON_INFERIORITY|ANOVA comparing changes in outcomes over time between EBQI and control groups|Mean Difference (Net)|-1.63|STANDARD_ERROR_OF_MEAN|2.45||0.51|TWO_SIDED|95.0|-6.6|3.33||The p-value reflects the interaction between EBQI and time.|ANOVA|The analysis is adjusted for EBQI and time.||||3.33|-6.60|0.51
71695832|NCT03238417|142906900|NON_INFERIORITY|ANOVA testing for change in outcome over time between EBQI and control arms|Mean Difference (Net)|3.11|STANDARD_ERROR_OF_MEAN|8.3||0.711|TWO_SIDED|95.0|-13.7|19.9||The p-value reflects the interaction between EBQI and time|ANOVA|||||19.9|-13.7|0.711
71695833|NCT03238417|142906901|NON_INFERIORITY|ANOVA comparing changes in outcome over time between EBQI and control arms|Mean Difference (Net)|8.49|STANDARD_ERROR_OF_MEAN|8.7||0.335|TWO_SIDED|95.0|-9.1|26.1||The p-value reflects the interaction term between EBQI and time.|ANOVA|||||26.1|-9.1|0.335
71695834|NCT03238417|142906902|NON_INFERIORITY|Analysis of Variance testing for change in outcome between EBQI and control groups from baseline to 12 months.|Mean Difference (Net)|-13.8|STANDARD_ERROR_OF_MEAN|12.3||0.268|TWO_SIDED|95.0|-38.7|11.1||P-value is from the interaction term between EBQI and time.|ANOVA|||||11.1|-38.7|0.268
71695835|NCT03238417|142906903|NON_INFERIORITY|Analysis of Variance testing the differences between EBQI and control from baseline and 24 months|Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|12.6||0.991|TWO_SIDED|95.0|-25.6|25.3||P-value is from the interaction between EBQI and time.|ANOVA|||||25.3|-25.6|0.991
71695836|NCT01239797|142906929|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0014|TWO_SIDED|95.0|0.6|0.89|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.89|0.60|0.0014
71695837|NCT01239797|142906930|SUPERIORITY||Hazard Ratio (HR)|0.72||||0.0005|TWO_SIDED|95.0|0.6|0.87|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||0.87|0.60|0.0005
71695838|NCT01239797|142906931|SUPERIORITY||Odds Ratio (OR)|1.95||||0.0002|TWO_SIDED|95.0|1.36|2.78|||Cochran-Mantel-Haenszel|Stratified by B2 microglobulin (\<3.5 mg/L vs \>=3.5 mg/L), number of prior lines of therapy (1 vs \>=2), and immunomodulatory drug use at randomization||Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone||2.78|1.36|0.0002
71695839|NCT01239797|142906931|SUPERIORITY||Difference in ORR|12.7|||||TWO_SIDED|95.0|6.2|19.3||||||Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)||19.3|6.2|
71695840|NCT00678418|142906990|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Van der Waerden|||Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.||||0.0002
71695841|NCT00678418|142906991|SUPERIORITY_OR_OTHER|||||||0.0042||95.0||||A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.|Kaplan Meier|||P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.||||0.0042
71695842|NCT00678418|142906992|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|95.0|||||Chi-squared|||"P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.~Calculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method."||||<0.0001
71695843|NCT00678418|142906993|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|0.75||||0.0154||95.0|0.6|0.95|||Chi-squared|||"Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.~Subjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result."||0.95|0.60|0.0154
71695844|NCT00678418|142906994|SUPERIORITY_OR_OTHER|||||||0.0031||95.0|||||van der Waerden|||Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.||||0.0031
71695845|NCT00359203|142907008|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.43||||0.04|TWO_SIDED|95.0|0.19|0.96|||Log Rank|The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.|numerator=pacemaker ON denominator=pacemaker OFF|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.||0.96|0.19|0.04
71761162|NCT02023697|143024015|OTHER||Hazard Ratio (HR)|1.059||||0.7896|TWO_SIDED|80.0|0.804|1.396|||Log Rank||Arm C/Arm A|||1.396|0.804|0.7896
71695846|NCT00359203|142907008|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.|Hazard Ratio (HR)|0.43||||0.039|TWO_SIDED|95.0|0.19|0.96||For the final analysis the threshold of statistical significance was set at 0.04.|Log Rank||Numerator=pacemaker ON denominator=pacemaker OFF|||0.96|0.19|0.039
71695847|NCT01764841|142907035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.7331||||0.065|TWO_SIDED|97.5|0.5027|1.069|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||1.0690|0.5027|0.0650
71695848|NCT01764841|142907035|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5333||||0.0005|TWO_SIDED|97.5|0.3568|0.7971|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.||0.7971|0.3568|0.0005
71695849|NCT01764841|142907036|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.8615||||0.2944|TWO_SIDED|97.5|0.6264|1.1848|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 28 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.1848|0.6264|0.2944
71695850|NCT01764841|142907036|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.7329||||0.0382|TWO_SIDED|97.5|0.5237|1.0256|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 14 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.||1.0256|0.5237|0.0382
71695851|NCT01103323|142907047|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.774||||0.005178||95.0|0.636|0.942||According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).|Log Rank||Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O'Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.||0.942|0.636|0.005178
71695852|NCT01103323|142907048|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.494|||<|1e-06||95.0|0.419|0.582||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Log Rank||Hazard ratio (Regorafenib / Placebo)|Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.||0.582|0.419|<0.000001
71695853|NCT01103323|142907049|SUPERIORITY_OR_OTHER||Difference|-0.6||||0.188432||95.0|-1.74|0.53||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||0.53|-1.74|0.188432
71695854|NCT01103323|142907050|SUPERIORITY_OR_OTHER||Difference|-25.94|||<|1e-06||95.0|-32.06|-19.82||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.||-19.82|-32.06|<0.000001
71695855|NCT04794751|142907077|NON_INFERIORITY|Non-Inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.018|STANDARD_ERROR_OF_MEAN|0.0106|||TWO_SIDED|95.0|-0.039|0.002|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Distance (4m)||0.002|-0.039|
71695856|NCT04794751|142907077|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.007|STANDARD_ERROR_OF_MEAN|0.0127|||TWO_SIDED|95.0|-0.032|0.018|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Intermediate (64cm)||0.018|-0.032|
71695857|NCT04794751|142907077|NON_INFERIORITY|Non-inferiority was declared if the upper limit of the 95% confidence interval of the LSM difference between the Test and Control was below 0.05 logMAR.|least-square mean difference|-0.01|STANDARD_ERROR_OF_MEAN|0.0124|||TWO_SIDED|95.0|-0.034|0.015|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|Near (40cm)||0.015|-0.034|
71695858|NCT04794751|142907078|NON_INFERIORITY|Non-inferiority was declared if the lower limit of the 95% confidence interval for the least-square mean difference was greater than -5.|least-square mean difference|0.1|STANDARD_ERROR_OF_MEAN|2.34|||TWO_SIDED|95.0|-4.6|4.8|||Linear Mixed Model|Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom.|LS Mean difference was calculated as Test minus Control|||4.8|-4.6|
71695859|NCT03044314|142907114|SUPERIORITY|||||||0.148|||||||t-test, 2 sided|||Null hypothesis: inhalation with iNO (the gold standard) would provide greater response than the comparator (iloprost).||||0.148
71695860|NCT03044314|142907116|SUPERIORITY|||||||0.346|||||||Fisher Exact|||Null hypothesis was that fewer patients receiving iloprost (new agent) would respond compared to iNO (the gold standard).||||0.346
71695861|NCT02563899|142907149|SUPERIORITY_OR_OTHER||Percent difference in treatment|-1.0|||||TWO_SIDED|95.0|-42.2|39.9||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-30%||39.9|-42.2|
71695862|NCT02563899|142907149|SUPERIORITY_OR_OTHER||Percent difference in treatment|1.0|||||TWO_SIDED|95.0|-39.9|42.2||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD vs Vehicle: \<=-50%||42.2|-39.9|
71695863|NCT02563899|142907149|SUPERIORITY_OR_OTHER||Percent difference in treatment|9.0|||||TWO_SIDED|95.0|-25.2|44.0||||||Umeclidinium, 2 mg/cm\^2 of 1.85%, OD Vs Vehicle: \<=-70%||44.0|-25.2|
71695864|NCT02563899|142907151|SUPERIORITY_OR_OTHER||Percent difference in treatment|27.0|||||TWO_SIDED|95.0|-8.5|62.6||||||||62.6|-8.5|
71695865|NCT00794664|142907183|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C was approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Enrollment was to be conducted such that at least 51 patients were randomized to allow for potential exclusions from an analysis set.||||<0.001
71695866|NCT00794664|142907185|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71943630|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Dressing and Grooming|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.14|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.14|-0.49|<0.001
71943631|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Arising|-0.32|||<|0.001|TWO_SIDED|95.0|-0.47|-0.16|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL||-0.16|-0.47|<0.001
71943632|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Eating|-0.48|||<|0.001|TWO_SIDED|95.0|-0.65|-0.3|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL||-0.30|-0.65|<0.001
71943633|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Walking|-0.26||||0.003|TWO_SIDED|95.0|-0.44|-0.09|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.09|-0.44|0.003
71943634|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Hygiene|-0.22||||0.01|TWO_SIDED|95.0|-0.39|-0.05|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.05|-0.39|0.010
71943635|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Reaching|-0.43|||<|0.001|TWO_SIDED|95.0|-0.61|-0.25|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.25|-0.61|<0.001
71695867|NCT00794664|142907187|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
71695868|NCT00794664|142907189|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
71695869|NCT00794664|142907191|SUPERIORITY_OR_OTHER|||||||0.034||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.034
71695870|NCT00794664|142907193|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
71695871|NCT00794664|142907195|SUPERIORITY_OR_OTHER||||||<|0.032||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.032
71695872|NCT00794664|142907197|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||<0.001
71695873|NCT00794664|142907199|SUPERIORITY_OR_OTHER|||||||0.278||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.278
71695874|NCT00794664|142907201|SUPERIORITY_OR_OTHER|||||||0.647||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.647
71695875|NCT01062308|142907203|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|-11.8||||0.03|TWO_SIDED|95.0|-22.6|-1.1|||Mixed Models Analysis|||||-1.1|-22.6|0.03
71695876|NCT01062308|142907204|SUPERIORITY_OR_OTHER||Mean difference from baseline to day 30|6.6||||0.16|TWO_SIDED|95.0|-2.7|15.9|||Mixed Models Analysis|||||15.9|-2.7|0.16
71695877|NCT00457730|142907205|SUPERIORITY_OR_OTHER|||||||0.016|TWO_SIDED||||||t-test, 2 sided|||||||0.016
71695878|NCT00457730|142907206|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||t-test, 2 sided|||||||0.002
71695879|NCT00457730|142907207|SUPERIORITY_OR_OTHER|||||||0.074|TWO_SIDED||||||t-test, 2 sided|||||||0.074
71695880|NCT00496769|142907232|SUPERIORITY||Hazard Ratio (HR)|0.45|||<|1e-05|TWO_SIDED|95.0|0.32|0.62|||Log Rank|||||0.62|0.32|<0.00001
71695881|NCT00496769|142907233|SUPERIORITY||Hazard Ratio (HR)|0.66||||0.00026|TWO_SIDED|95.0|0.53|0.83|||Log Rank||Vascular death|||0.83|0.53|0.00026
71695882|NCT00496769|142907234|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.06782|TWO_SIDED|95.0|0.62|1.02|||Log Rank||All-cause death|||1.02|0.62|0.06782
71695883|NCT00496769|142907234|SUPERIORITY||Hazard Ratio (HR)|0.73||||0.0028|TWO_SIDED|95.0|0.6|0.9|||Log Rank||Composite endpoint of major vascular events and major bleeding-net clinical benefit|||0.90|0.60|0.00280
71695884|NCT00496769|142907234|SUPERIORITY||Hazard Ratio (HR)|0.87||||0.36586|TWO_SIDED|95.0|0.65|1.17|||Log Rank||Vascular death|||1.17|0.65|0.36586
71695885|NCT00496769|142907235|OTHER||Hazard Ratio (HR)|1.54||||0.0716|TWO_SIDED|95.0|0.96|2.45|||Log Rank||Major bleeding|||2.45|0.96|0.0716
71695886|NCT00496769|142907235|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank||All bleeding|||1.53|1.10|0.0017
71695887|NCT00496769|142907235|OTHER||Hazard Ratio (HR)|1.38||||0.0144|TWO_SIDED|95.0|1.07|1.78|||Log Rank||Major or CNRM bleeding|||1.78|1.07|0.0144
71695888|NCT00496769|142907236|OTHER||Hazard Ratio (HR)|1.3||||0.0017|TWO_SIDED|95.0|1.1|1.53|||Log Rank|||||1.53|1.10|0.0017
71695889|NCT02812186|142907249|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71695890|NCT02812186|142907250|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||||||0.28
71695891|NCT02812186|142907251|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||||||0.63
71695892|NCT01926028|142907295|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.39||||0.03|TWO_SIDED|95.0|0.17|0.91|||Wilcoxon (Mann-Whitney)|||||0.91|0.17|0.03
71695893|NCT01926028|142907296|EQUIVALENCE|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.55||||0.1|TWO_SIDED|95.0|0.27|1.13|||Wilcoxon (Mann-Whitney)|||||1.13|0.27|0.10
71695894|NCT01130272|142907305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.457||||0.052|TWO_SIDED|95.0|0.994|6.077|||ANCOVA|||||6.077|0.994|0.052
71695895|NCT01130272|142907305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.383||||0.041|TWO_SIDED|95.0|1.036|5.478|||ANCOVA|||||5.478|1.036|0.041
71695896|NCT01130272|142907305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.079||||0.09|TWO_SIDED|95.0|0.893|4.842|||ANCOVA|||||4.842|0.893|0.090
71695897|NCT01130272|142907305|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.797||||0.015|TWO_SIDED|95.0|1.227|6.376|||ANCOVA|||||6.376|1.227|0.015
71695898|NCT01130272|142907306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.719||||0.449|TWO_SIDED|95.0|0.306|1.689|||ANCOVA|||||1.689|0.306|0.449
71695899|NCT01130272|142907306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.208||||0.583|TWO_SIDED|95.0|0.615|2.373|||ANCOVA|||||2.373|0.615|0.583
71695900|NCT01130272|142907306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.014||||0.03|TWO_SIDED|95.0|1.069|3.795|||ANCOVA|||||3.795|1.069|0.030
71695901|NCT01130272|142907306|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.395||||0.326|TWO_SIDED|95.0|0.717|2.716|||ANCOVA|||||2.716|0.717|0.326
71695902|NCT00737048|142907320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.3|STANDARD_DEVIATION|8.06|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 1 for Total pain relief based on numerical rating scale score||||<0.0001
71695903|NCT00737048|142907320|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.3|STANDARD_DEVIATION|7.99|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 2 for Total pain relief based on numerical rating scale score||||<0.0001
71695904|NCT00641056|142907332|NON_INFERIORITY_OR_EQUIVALENCE|Power: 205 patients per treatment group would provide approximately 92% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|Least Squares Mean Difference|-0.16|STANDARD_ERROR_OF_MEAN|0.07||0.017|TWO_SIDED|95.0|-0.29|-0.03||No adjustments for multiplicity were performed|Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference \[exenatide once weekly-insulin glargine\]\<0; noninferiority is concluded if this upper limit\<0.3%.||-0.03|-0.29|0.017
71695905|NCT00641056|142907333|SUPERIORITY_OR_OTHER|||||||0.097|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country served as the stratification factors.||||0.097
71695906|NCT00641056|142907334|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|95.0||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c \<=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.||||0.002
71695907|NCT00641056|142907335|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.63|STANDARD_ERROR_OF_MEAN|0.19||0.001|TWO_SIDED|95.0|0.25|1.0||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.00|0.25|0.001
71695908|NCT00641056|142907336|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-4.05|STANDARD_ERROR_OF_MEAN|0.27|<|0.001|TWO_SIDED|95.0|-4.57|-3.52||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||-3.52|-4.57|<.001
71695909|NCT00641056|142907337|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.07|STANDARD_ERROR_OF_MEAN|0.07||0.292|TWO_SIDED|95.0|-0.21|0.06||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.06|-0.21|0.292
71761163|NCT02023697|143024019|OTHER||Hazard Ratio (HR)|0.986||||0.9274|TWO_SIDED|80.0|0.803|1.21|||Log Rank||Arm B/Arm (A+C)|||1.210|0.803|0.9274
71761164|NCT02023697|143024021|OTHER||Hazard Ratio (HR)|1.134||||0.5754|TWO_SIDED|80.0|0.85|1.514|||Log Rank||Arm C/Arm A|||1.514|0.850|0.5754
71695910|NCT00641056|142907338|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|-0.02|STANDARD_ERROR_OF_MEAN|0.02||0.377|TWO_SIDED|95.0|-0.05|0.02||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||0.02|-0.05|0.377
71695911|NCT00641056|142907339|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|1.07|STANDARD_ERROR_OF_MEAN|0.04||0.077|TWO_SIDED|95.0|0.99|1.15||No adjustments for multiplicity were performed|Mixed Models Analysis|||Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.||1.15|0.99|0.077
71695912|NCT01674725|142907359|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.|Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|95.9|
71695913|NCT01674725|142907359|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have \>90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.||100.0|94.6|
71695914|NCT01674725|142907360|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|||||||Fisher Exact|||||||<0.001
71695915|NCT01674725|142907361|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|97.7|||||TWO_SIDED|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|||100.0|94.6|
71695916|NCT01674725|142907361|SUPERIORITY_OR_OTHER_LEGACY||Percentage of Participants|100.0|||||TWO_SIDED|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority|||100|95.9|
71695917|NCT01674725|142907361|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Percentage of Participants|2.3|||||TWO_SIDED|95.0|-0.8|5.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|||5.4|-0.8|
71695918|NCT02900352|142907364|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.0130
71943636|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Gripping|-0.32|||<|0.001|TWO_SIDED|95.0|-0.49|-0.15|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.15|-0.49|<0.001
71695919|NCT02900352|142907365|SUPERIORITY|||||||0.148|||||||Chi-squared|||||||0.148
71695920|NCT02900352|142907366|SUPERIORITY|||||||0.054|||||||ANOVA|||||||.054
71695921|NCT02900352|142907367|SUPERIORITY|||||||0.035|||||||Mixed Models Analysis|||||||0.035
71695922|NCT02900352|142907368|SUPERIORITY|||||||0.889|||||||ANOVA|||||||0.889
71695923|NCT02900352|142907369|SUPERIORITY|||||||0.482|||||||ANOVA|||||||0.482
71695924|NCT02900352|142907370|SUPERIORITY|||||||0.04|||||||ANOVA|||||||0.04
71943637|NCT00048581|143408674|SUPERIORITY_OR_OTHER||Adj M Chg from BL: Activities|-0.4|||<|0.001|TWO_SIDED|95.0|-0.58|-0.22|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL||-0.22|-0.58|<0.001
71695925|NCT03074695|142907371|OTHER||Risk Difference (RD)|3.03||||0.766|TWO_SIDED|95.0|-14.02|20.08|||Regression, Logistic|Adjusted for baseline characteristics (parturient race, ethnicity, height, and induction status).||||20.08|-14.02|0.766
71695926|NCT01774981|142907381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0449|||||||t-test, 1 sided|||||||0.0449
71695927|NCT01774981|142907381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0808|||||||t-test, 1 sided|||||||0.0808
71943638|NCT01059903|143408730|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9028|||||TWO_SIDED|90.0|0.8411|0.969|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9690|0.8411|
71943639|NCT01059903|143408731|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9506|||||TWO_SIDED|90.0|0.8833|1.0231|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||1.0231|0.8833|
71943640|NCT01059903|143408732|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9046|||||TWO_SIDED|90.0|0.8437|0.9699|||ANOVA|ANOVA for log-transformed values has been used as the basis for calculation of point estimates (LS-Means) and Confidence Intervals (CIs).|Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).||0.9699|0.8437|
71943641|NCT04753437|143408861|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric Least Squares (LS) Mean Ratio|1.3|||||TWO_SIDED|90.0|0.94|1.81||||||||1.81|0.94|
71943642|NCT04753437|143408862|EQUIVALENCE|Results were based on analysis of variance model with treatment as a fixed effect.|Geometric LS Mean Ratio|1.07|||||TWO_SIDED|90.0|0.82|1.4||||||||1.40|0.82|
71943643|NCT00358449|143408950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.55||||0.865|TWO_SIDED|95.0|0.04|5.44|||Regression, Logistic|||||5.44|0.04|0.865
71943644|NCT00358449|143408950|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.21||||0.19|TWO_SIDED|95.0|0.01|2.07|||Regression, Logistic|||||2.07|0.01|0.190
71943645|NCT00358449|143408953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.551|TWO_SIDED|95.0|-0.303|0.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.560|-0.303|0.551
71943646|NCT00358449|143408953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12||||0.593||95.0|-0.331|0.572|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.572|-0.331|0.593
71943647|NCT00358449|143408953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.334||||0.239|TWO_SIDED|95.0|-0.232|0.901|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.901|-0.232|0.239
71943648|NCT00358449|143408953|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.211||||0.488|TWO_SIDED|95.0|-0.401|0.823|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.823|-0.401|0.488
71943649|NCT00358449|143408954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.139|TWO_SIDED|95.0|-0.121|0.833|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.833|-0.121|0.139
71943650|NCT00358449|143408954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.371||||0.145||95.0|-0.133|0.874|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.874|-0.133|0.145
71943651|NCT00358449|143408954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.433||||0.095|TWO_SIDED|95.0|-0.08|0.946|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.946|-0.080|0.095
71943652|NCT00358449|143408954|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.343||||0.219|TWO_SIDED|95.0|-0.214|0.899|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.899|-0.214|0.219
71943653|NCT00358449|143408955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.59||||0.832|TWO_SIDED|95.0|-13.47|16.65|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||16.65|-13.47|0.832
71943654|NCT00358449|143408955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.92||||0.622|TWO_SIDED|95.0|-12.01|19.84|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||19.84|-12.01|0.622
71943655|NCT00358449|143408955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.83||||0.317|TWO_SIDED|95.0|-11.86|35.52|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||35.52|-11.86|0.317
71943656|NCT00358449|143408955|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.1||||0.246|TWO_SIDED|95.0|-10.91|41.11|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||41.11|-10.91|0.246
71943657|NCT00358449|143408956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.28||||0.046|TWO_SIDED|95.0|0.39|38.18|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||38.18|0.39|0.046
71943658|NCT00358449|143408956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.21||||0.16|TWO_SIDED|95.0|-5.83|34.25|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||34.25|-5.83|0.160
71695928|NCT01774981|142907381|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2219|||||||t-test, 1 sided|||||||0.2219
71943659|NCT00358449|143408956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.69||||0.078|TWO_SIDED|95.0|-2.1|37.48|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.48|-2.10|0.078
71761165|NCT02023697|143024027|OTHER||Hazard Ratio (HR)|0.898||||0.6214|TWO_SIDED|80.0|0.678|1.188|||Log Rank||Arm B/Arm (A+C)|||1.188|0.678|0.6214
71943660|NCT00358449|143408956|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.11||||0.055|TWO_SIDED|95.0|-0.51|42.74|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||42.74|-0.51|0.055
71943661|NCT00358449|143408957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.324||||0.241|TWO_SIDED|95.0|-0.226|0.873|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.873|-0.226|0.241
71943662|NCT00358449|143408957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.371|TWO_SIDED|95.0|-0.32|0.839|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.839|-0.320|0.371
71943663|NCT00358449|143408957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.353||||0.291|TWO_SIDED|95.0|-0.317|1.023|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.023|-0.317|0.291
71761166|NCT02023697|143024029|OTHER||Hazard Ratio (HR)|0.863||||0.7214|TWO_SIDED|80.0|0.505|1.475|||Log Rank||Arm C/Arm A|||1.475|0.505|0.7214
71695929|NCT01324102|142907388|SUPERIORITY_OR_OTHER|||||||0.004|TWO_SIDED|95.0||||The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.|ANOVA|F=10.25||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.||||.004
71695930|NCT01324102|142907388|SUPERIORITY_OR_OTHER|||||||0.056|TWO_SIDED|||||F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.|ANOVA|||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.||||.056
71695931|NCT00386334|142907397|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695932|NCT00386334|142907400|SUPERIORITY_OR_OTHER|||||||0.0014||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0014
71695933|NCT00386334|142907403|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71943664|NCT00358449|143408957|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.176||||0.653|TWO_SIDED|95.0|-0.965|0.614|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.614|-0.965|0.653
71943665|NCT00358449|143408958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.06||||0.123|TWO_SIDED|95.0|-4.0|32.13|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||32.13|-4.00|0.123
71943666|NCT00358449|143408958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62||||0.551|TWO_SIDED|95.0|-13.29|24.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||24.54|-13.29|0.551
71943667|NCT00358449|143408958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.04||||0.141|TWO_SIDED|95.0|-5.61|37.7|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||37.70|-5.61|0.141
71943668|NCT00358449|143408958|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.42||||0.666|TWO_SIDED|95.0|-30.74|19.9|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||19.90|-30.74|0.666
71943669|NCT00358449|143408959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.088||||0.572|TWO_SIDED|95.0|-0.224|0.4|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.400|-0.224|0.572
71943670|NCT00358449|143408959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.012||||0.942|TWO_SIDED|95.0|-0.35|0.326|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.326|-0.350|0.942
71943671|NCT00358449|143408959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005||||0.96|TWO_SIDED|95.0|-0.188|0.197|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.197|-0.188|0.960
71695934|NCT00386334|142907406|SUPERIORITY_OR_OTHER|||||||0.0005||||||Multiple comparisons not applied due to only two treatments in study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0005
71943672|NCT00358449|143408959|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.105||||0.317|TWO_SIDED|95.0|-0.105|0.315|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.315|-0.105|0.317
71943673|NCT00358449|143408960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.666|TWO_SIDED|95.0|-6.39|4.12|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||4.12|-6.39|0.666
71943674|NCT00358449|143408960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.16||||0.45|TWO_SIDED|95.0|-7.87|3.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.56|-7.87|0.450
71943675|NCT00358449|143408960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.6||||0.215|TWO_SIDED|95.0|-12.0|2.81|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||2.81|-12.00|0.215
71943676|NCT00358449|143408960|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.898|TWO_SIDED|95.0|-8.61|7.58|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||7.58|-8.61|0.898
71943677|NCT00358449|143408961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.038||||0.762|TWO_SIDED|95.0|-0.217|0.294|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.294|-0.217|0.762
71943678|NCT00358449|143408961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.159||||0.235|TWO_SIDED|95.0|-0.426|0.108|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.108|-0.426|0.235
71695935|NCT00386334|142907409|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71943679|NCT00358449|143408961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.089||||0.607|TWO_SIDED|95.0|-0.259|0.436|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.436|-0.259|0.607
71943680|NCT00358449|143408961|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.068||||0.716|TWO_SIDED|95.0|-0.308|0.443|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.443|-0.308|0.716
71943681|NCT00358449|143408962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.691|TWO_SIDED|95.0|-0.365|0.545|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.545|-0.365|0.691
71943682|NCT00358449|143408962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.161||||0.5|TWO_SIDED|95.0|-0.639|0.317|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.317|-0.639|0.500
71943683|NCT00358449|143408962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.187||||0.568|TWO_SIDED|95.0|-0.474|0.849|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.849|-0.474|0.568
71943684|NCT00358449|143408962|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.076||||0.832|TWO_SIDED|95.0|-0.643|0.794|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.794|-0.643|0.832
71943685|NCT00358449|143408963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.515|TWO_SIDED|95.0|-3.45|1.76|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.76|-3.45|0.515
71943686|NCT00358449|143408963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.9||||0.496|TWO_SIDED|95.0|-1.74|3.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||3.54|-1.74|0.496
71943687|NCT00358449|143408963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.657|TWO_SIDED|95.0|-5.82|3.72|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||3.72|-5.82|0.657
71695936|NCT00386334|142907412|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695937|NCT00386334|142907415|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695938|NCT00386334|142907418|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695939|NCT00386334|142907421|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695940|NCT00386334|142907424|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695941|NCT00386334|142907427|SUPERIORITY_OR_OTHER|||||||0.1175||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.1175
71695942|NCT00386334|142907430|SUPERIORITY_OR_OTHER|||||||0.0717||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0717
71695943|NCT00386334|142907433|SUPERIORITY_OR_OTHER|||||||0.1182||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|||||||0.1182
71695944|NCT00386334|142907436|SUPERIORITY_OR_OTHER|||||||0.301||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.3010
71943688|NCT00358449|143408963|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.01||||0.691|TWO_SIDED|95.0|-6.11|4.09|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.09|-6.11|0.691
71943689|NCT00358449|143408964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.142|TWO_SIDED|95.0|-0.105|0.704|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.704|-0.105|0.142
71943690|NCT00358449|143408964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.354||||0.115|TWO_SIDED|95.0|-0.09|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.798|-0.090|0.115
71943691|NCT00358449|143408964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.182||||0.465|TWO_SIDED|95.0|-0.319|0.683|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.683|-0.319|0.465
71943692|NCT00358449|143408964|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.121||||0.649|TWO_SIDED|95.0|-0.417|0.66|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.660|-0.417|0.649
71695945|NCT00386334|142907439|SUPERIORITY_OR_OTHER|||||||0.78||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.7800
71695946|NCT00386334|142907442|SUPERIORITY_OR_OTHER|||||||0.0803||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0803
71695947|NCT00386334|142907445|SUPERIORITY_OR_OTHER|||||||0.2643||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2643
71695948|NCT00386334|142907448|SUPERIORITY_OR_OTHER|||||||0.0765||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0765
71695949|NCT00386334|142907451|SUPERIORITY_OR_OTHER|||||||0.2967||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.2967
71695950|NCT00386334|142907454|SUPERIORITY_OR_OTHER|||||||0.0634||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||0.0634
71943693|NCT00358449|143408965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37||||0.077|TWO_SIDED|95.0|-0.042|0.782|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.782|-0.042|0.077
71943694|NCT00358449|143408965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.356||||0.12|TWO_SIDED|95.0|-0.097|0.809|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.809|-0.097|0.120
71943695|NCT00358449|143408965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29||||0.345|TWO_SIDED|95.0|-0.326|0.906|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.906|-0.326|0.345
71943696|NCT00358449|143408965|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.128||||0.7|TWO_SIDED|95.0|-0.541|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||0.798|-0.541|0.700
71943697|NCT00358449|143408966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79||||0.609|TWO_SIDED|95.0|-8.79|5.22|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||5.22|-8.79|0.609
71695951|NCT00386334|142907457|SUPERIORITY_OR_OTHER||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate||||||<0.0001
71695952|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.54||||0.048|TWO_SIDED|95.0|1.0|2.36|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:~This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||2.36|1.0|0.048
71695953|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.16||||0.5|TWO_SIDED|95.0|0.75|1.81|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate||1.81|.75|0.50
71695954|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.0||||0.9|TWO_SIDED|0.97|0.97|1.03|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.03|0.97|0.90
71695955|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.17||||0.024|TWO_SIDED|95.0|1.02|1.34|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.34|1.02|0.024
71695956|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.32||||0.045|TWO_SIDED|95.0|1.01|1.72|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.72|1.01|0.045
71695957|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.11||||0.31|TWO_SIDED|95.0|0.9|1.37|||Regression, Cox|||Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.37|0.90|0.31
71695958|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.07||||0.51|TWO_SIDED|95.0|0.88|1.29|||Regression, Cox|||cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.29|0.88|0.51
71695959|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|1.0||||0.97|TWO_SIDED|95.0|0.79|1.26|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.26|0.79|0.9700
71695960|NCT00902577|142907466|OTHER||Hazard Ratio (HR)|0.99||||0.9007|TWO_SIDED|95.0|0.91|1.09|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.09|0.91|0.9007
71695961|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|1.24||||0.33|TWO_SIDED|95.0|0.8|1.91|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.91|.80|0.33
71695962|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|0.93||||0.72|TWO_SIDED|95.0|0.61|1.4|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.||1.4|.61|0.72
71943698|NCT00358449|143408966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.59||||0.882|TWO_SIDED|95.0|-8.55|7.38|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||7.38|-8.55|0.882
71943699|NCT00358449|143408966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6||||0.595|TWO_SIDED|95.0|-7.68|4.47|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||4.47|-7.68|0.595
71943700|NCT00358449|143408966|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.45||||0.895|TWO_SIDED|95.0|-7.34|6.44|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||6.44|-7.34|0.895
71943701|NCT00358449|143408967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.513||||0.062|TWO_SIDED|95.0|-0.028|1.055|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||1.055|-0.028|0.062
71943702|NCT00358449|143408967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.241||||0.425|TWO_SIDED|95.0|-0.369|0.852|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||0.852|-0.369|0.425
71943703|NCT00358449|143408967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.71||||0.082|TWO_SIDED|95.0|-0.096|1.516|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.516|-0.096|0.082
71695963|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|1.01||||0.355|TWO_SIDED|95.0|0.98|1.04|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.04|.98|0.355
71695964|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|1.1||||0.074|TWO_SIDED|95.0|0.99|1.23|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.23|0.99|0.074
71695965|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|1.3||||0.021|TWO_SIDED|95.0|1.04|1.63|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.63|1.04|0.021
71695966|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|1.28||||0.0096|TWO_SIDED|95.0|1.06|1.54|||Regression, Cox|||"Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2\*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.~The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.54|1.06|0.0096
71695967|NCT00902577|142907467|OTHER||Hazard Ratio (HR)|1.18||||0.038|TWO_SIDED|95.0|1.01|1.38|||Regression, Cox|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.~nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."||1.38|1.01|0.038
71695968|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.682||||0.3253|TWO_SIDED|95.0|0.318|1.463|||Regression, Logistic|||Logistic regression for SUVpeak to predict PFS6||1.463|0.318|0.3253
71695969|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.991||||0.9836|TWO_SIDED|95.0|0.403|2.434|||Regression, Logistic|||TBmax was modeled with a univariate logistic regression model for PFS6.||2.434|0.403|0.9836
71695970|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.957||||0.1566|TWO_SIDED|95.0|0.9|1.017|||Regression, Logistic|||Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .||1.017|0.900|0.1566
71695971|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.993||||0.9554|TWO_SIDED|95.0|0.775|1.273|||Regression, Logistic|||"Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate logistic regression model for PFS6."||1.273|0.775|0.9554
71695972|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.919||||0.6941|TWO_SIDED|95.0|0.602|1.402|||Regression, Logistic|||"Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate logistic regression model for PFS6"||1.402|0.602|0.6941
71695973|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.744||||0.134|TWO_SIDED|95.0|0.506|1.095|||Regression, Logistic|||"Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).~nRCBV was modeled with a univariate logistic regression model for PFS6."||1.095|0.506|0.1340
71695974|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.821||||0.2642|TWO_SIDED|95.0|0.58|1.161|||Regression, Logistic|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.~nCBF was modeled with a univariate logistic regression model for PFS6."||1.161|0.580|0.2642
71695975|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.855||||0.5069|TWO_SIDED|95.0|0.539|1.357|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6||1.357|0.539|0.5069
71695976|NCT00902577|142907467|OTHER||Odds Ratio (OR)|0.884||||0.1921|TWO_SIDED|95.0|0.735|1.064|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6||1.064|0.735|0.1921
71695977|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.61|||||TWO_SIDED|95.0|0.42|0.79||||||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.79|0.42|
71695978|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.59|||||TWO_SIDED|95.0|0.39|0.78||||||"T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.78|0.39|
71695979|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.46|0.83||||||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."||0.83|0.46|
71695980|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.62|||||TWO_SIDED|95.0|0.42|0.83||||||"mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9."||0.83|0.42|
71695981|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||TWO_SIDED|95.0|0.44|0.84||||||"Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9."||0.84|0.44|
71695982|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.54|0.89||||||nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.54|
71695983|NCT00902577|142907467|OTHER|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||TWO_SIDED|95.0|0.55|0.89||||||nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.||0.89|0.55|
71695984|NCT00501631|142907482|SUPERIORITY_OR_OTHER|||||||0.336||95.0|||||Van der Waerden test|||The null hypothesis that there is no difference between two treatment groups (i.e. Placebo and Vivitrol) was tested using a two-sided Van der Waerden test. Response profiles were tabulated as a cumulative percent of subjects at each decile of percent heavy drinking days.||||0.336
71695985|NCT04456686|142907487|SUPERIORITY||Posterior Mean Difference|-0.03|||||TWO_SIDED|95.0|-0.77|0.7|||Bayesian Mixed Model Analysis|||||0.70|-0.77|
71695986|NCT04456686|142907488|SUPERIORITY||Posterior Mean Difference|0.58|||||TWO_SIDED|95.0|-0.82|1.96|||Bayesian Mixed Model Analysis|||||1.96|-0.82|
71695987|NCT04456686|142907489|SUPERIORITY||Posterior Mean Difference|0.1|||||TWO_SIDED|95.0|-0.45|0.63|||Bayesian Mixed Model Analysis|||||0.63|-0.45|
71695988|NCT04456686|142907490|SUPERIORITY||Posterior Mean Difference|0.9|||||TWO_SIDED|95.0|-3.31|5.06|||Bayesian Mixed Model Analysis|||||5.06|-3.31|
71695989|NCT04456686|142907491|SUPERIORITY||Posterior Mean Difference|0.03|||||TWO_SIDED|95.0|-0.46|0.5|||Bayesian Mixed Model Analysis|||||0.50|-0.46|
71695990|NCT04456686|142907492|SUPERIORITY||Posterior Mean Difference|0.11|||||TWO_SIDED|95.0|-0.72|0.91|||Bayesian Mixed Model Analysis|||||0.91|-0.72|
71695991|NCT04456686|142907493|SUPERIORITY||Posterior Mean Difference|2.45|||||TWO_SIDED|95.0|-7.27|12.2|||Bayesian Mixed Model Analysis|||||12.20|-7.27|
71695992|NCT04456686|142907494|SUPERIORITY||Posterior Mean Difference|0.4|||||TWO_SIDED|95.0|-0.04|0.85|||Bayesian Mixed Model Analysis|||||0.85|-0.04|
71695993|NCT04456686|142907495|SUPERIORITY||Posterior Mean Difference|168.61|||||TWO_SIDED|95.0|-38.22|379.2|||Bayesian Mixed Model Analysis|||||379.20|-38.22|
71695994|NCT04456686|142907496|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.07|0.06|||Bayesian Mixed Model Analysis|||||0.06|-0.07|
71695995|NCT01329198|142907499|SUPERIORITY||Mean Difference (Final Values)|-17.8|STANDARD_DEVIATION|9.4||0.013|TWO_SIDED||||||ANOVA||Mean change in YGTSS scores from Baseline to 6 Months across all study participants presented.|||||0.013
71695996|NCT00473083|142907501|SUPERIORITY_OR_OTHER|||||||0.8769||||||P for arm 1 v arms 2 and 3 combined|Chi-squared|||||||0.8769
71695997|NCT00473083|142907501|SUPERIORITY_OR_OTHER|||||||0.147||||||P for arm 1 v arms 2 and 3 combined|Wilcoxon (Mann-Whitney)|||||||0.147
71695998|NCT00473083|142907502|SUPERIORITY_OR_OTHER|||||||0.1503||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.1503
71695999|NCT00473083|142907502|SUPERIORITY_OR_OTHER|||||||0.4681||||||P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.4681
71696000|NCT00473083|142907502|SUPERIORITY_OR_OTHER|||||||0.0196||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)|||||||0.0196
71696001|NCT00473083|142907502|SUPERIORITY_OR_OTHER|||||||0.1658||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.1658
71696002|NCT00473083|142907502|SUPERIORITY_OR_OTHER||||||>|0.9999||||||"P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.~P-value was calculated to be \>0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms."|Wilcoxon (Mann-Whitney)|||||||>0.9999
71696003|NCT00473083|142907502|SUPERIORITY_OR_OTHER|||||||0.285||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)|||||||0.285
71696004|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.5097|||||||Chi-squared|||Maximal Rash Grade 1||||0.5097
71696005|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.474|||||||Chi-squared|||Maximal Rash Grade 2a||||0.4740
71696006|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.2123|||||||Chi-squared|||Maximal Severity Grade 2b||||0.2123
71696007|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.5004|||||||Chi-squared|||Maximal Severity Grade 3||||0.5004
71696008|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.9072|||||||Chi-squared|||Maximal Severity Grade 1||||0.9072
71696009|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.0464|||||||Chi-squared|||Maximal Severity Grade 2a||||0.0464
71696010|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.6759|||||||Chi-squared|||Maximal Severity Grade 2b||||0.6759
71696011|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.0065|||||||Chi-squared|||Maximal Severity Grade 3||||0.0065
71696012|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.5898|||||||Chi-squared|||Maximal Severity Grade 1||||0.5898
71696013|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.1921|||||||Chi-squared|||Maximal Severity Grade 2a||||0.1921
71696014|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.0882|||||||Chi-squared|||Maximal Severity Grade 2b||||0.0882
71696015|NCT00473083|142907503|SUPERIORITY_OR_OTHER|||||||0.0344|||||||Chi-squared|||Maximal Severity Grade 3||||0.0344
71696016|NCT00473083|142907504|SUPERIORITY_OR_OTHER|||||||0.3834|||||||Log Rank|||||||0.3834
71696017|NCT00473083|142907506|SUPERIORITY_OR_OTHER|||||||0.0147|||||||Wilcoxon (Mann-Whitney)|||||||0.0147
71696018|NCT02915835|142907508|SUPERIORITY|||||||0.7|||||||ANCOVA|||||||0.70
71696019|NCT02915835|142907509|SUPERIORITY|||||||0.61|||||||Fisher Exact|||||||0.61
71696020|NCT02915835|142907510|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696021|NCT02915835|142907511|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696022|NCT02915835|142907512|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696023|NCT02915835|142907513|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696024|NCT02915835|142907514|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696025|NCT02915835|142907515|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696026|NCT02915835|142907516|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696027|NCT02915835|142907517|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696028|NCT02915835|142907518|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696029|NCT02915835|142907519|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71943704|NCT00358449|143408967|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25||||0.564|TWO_SIDED|95.0|-0.631|1.132|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||1.132|-0.631|0.564
71943705|NCT00358449|143408968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45||||0.27|TWO_SIDED|95.0|-7.77|26.67|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.|||26.67|-7.77|0.270
71696030|NCT02915835|142907520|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696031|NCT02915835|142907521|SUPERIORITY|||||||0.56|||||||Log Rank|||||||.56
71696032|NCT02915835|142907522|SUPERIORITY|||||||0.35|||||||Log Rank|||||||.35
71696033|NCT02915835|142907524|SUPERIORITY|||||||0.76|||||||ANCOVA|||||||.76
71696034|NCT02915835|142907525|SUPERIORITY|||||||0.57|||||||ANCOVA|||||||.57
71696035|NCT02915835|142907526|SUPERIORITY|||||||0.4|||||||ANCOVA|||||||.40
71943706|NCT00358449|143408968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.12||||0.664|TWO_SIDED|95.0|-15.11|23.36|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||23.36|-15.11|0.664
71696036|NCT02915835|142907527|SUPERIORITY|||||||0.49|||||||ANCOVA|||||||.49
71696037|NCT02915835|142907528|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||.75
71696038|NCT02915835|142907529|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||.41
71696039|NCT02915835|142907530|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
71696040|NCT02915835|142907531|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
71696041|NCT02915835|142907532|SUPERIORITY|||||||0.11|||||||ANCOVA|||||||0.11
71696042|NCT02915835|142907533|SUPERIORITY|||||||0.66|||||||ANCOVA|||||||0.66
71696043|NCT02915835|142907534|SUPERIORITY|||||||0.27|||||||ANCOVA|||||||0.27
71696044|NCT02915835|142907535|SUPERIORITY|||||||0.54|||||||ANCOVA|||||||0.54
71696045|NCT02915835|142907536|SUPERIORITY|||||||0.9|||||||ANCOVA|||||||.90
71696046|NCT02915835|142907537|SUPERIORITY|||||||0.68|||||||ANCOVA|||||||.68
71696047|NCT02915835|142907538|SUPERIORITY|||||||0.25|||||||ANCOVA|||||||.25
71696048|NCT02915835|142907539|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||.95
71696049|NCT02915835|142907540|SUPERIORITY|||||||0.38|||||||ANCOVA|||||||0.38
71696050|NCT02915835|142907541|SUPERIORITY|||||||0.82|||||||ANCOVA|||||||.82
71696051|NCT02915835|142907542|SUPERIORITY|||||||0.47|||||||ANCOVA|||||||.47
71943707|NCT00358449|143408968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.57||||0.381|TWO_SIDED|95.0|-13.81|34.94|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||34.94|-13.81|0.381
71943708|NCT00358449|143408968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.49||||0.672|TWO_SIDED|95.0|-20.87|31.86|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.|||31.86|-20.87|0.672
71943709|NCT00358449|143408969|SUPERIORITY_OR_OTHER|||||||0.4||95.0|||||Cochran-Mantel-Haenszel|||||||0.400
71943710|NCT00358449|143408969|SUPERIORITY_OR_OTHER|||||||0.111||95.0|||||Cochran-Mantel-Haenszel|||||||0.111
71943711|NCT00358449|143408970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.3||||0.421|TWO_SIDED|95.0|-71.1|34.4|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||34.4|-71.1|0.421
71943712|NCT00358449|143408970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.1||||0.633|TWO_SIDED|95.0|-44.6|40.5|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12|||40.5|-44.6|0.633
71696052|NCT02915835|142907543|SUPERIORITY|||||||0.35|||||||ANCOVA|||||||0.35
71696053|NCT02915835|142907544|SUPERIORITY|||||||0.84|||||||ANCOVA|||||||0.84
71696054|NCT02915835|142907545|SUPERIORITY|||||||0.55|||||||ANCOVA|||||||0.55
71696055|NCT02915835|142907547|SUPERIORITY|||||||0.34|||||||ANCOVA|||||||0.34
71696056|NCT02915835|142907548|SUPERIORITY|||||||0.36|||||||ANCOVA|||||||0.36
71696057|NCT02915835|142907549|SUPERIORITY|||||||0.04|||||||ANCOVA|||||||0.04
71696058|NCT02915835|142907550|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
71696059|NCT02915835|142907551|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71696060|NCT02915835|142907552|SUPERIORITY|||||||0.41|||||||ANCOVA|||||||0.41
71696061|NCT02915835|142907553|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71696062|NCT02915835|142907554|SUPERIORITY|||||||0.85|||||||ANCOVA|||||||0.85
71696063|NCT02915835|142907555|SUPERIORITY|||||||0.75|||||||ANCOVA|||||||0.75
71696064|NCT02915835|142907556|SUPERIORITY|||||||0.95|||||||ANCOVA|||||||0.95
71696065|NCT02915835|142907557|SUPERIORITY|||||||0.31|||||||ANCOVA|||||||0.31
71696066|NCT02915835|142907558|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71696067|NCT02915835|142907559|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
71696068|NCT02915835|142907560|SUPERIORITY|||||||0.47|||||||Fisher Exact|||||||0.47
71696069|NCT02915835|142907561|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.00
71696070|NCT02915835|142907562|SUPERIORITY|||||||0.73|||||||ANCOVA|||||||0.73
71696071|NCT02915835|142907563|SUPERIORITY|||||||0.32|||||||ANCOVA|||||||0.32
71696072|NCT02915835|142907564|SUPERIORITY|||||||0.45|||||||ANCOVA|||||||0.45
71696073|NCT02915835|142907565|SUPERIORITY|||||||0.58|||||||ANCOVA|||||||0.58
71696074|NCT02915835|142907566|SUPERIORITY|||||||0.39|||||||ANCOVA|||||||0.39
71696075|NCT02915835|142907567|SUPERIORITY|||||||0.14|||||||ANCOVA|||||||0.14
71696076|NCT00113607|142907568|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.79||||0.019|TWO_SIDED|95.0|0.65|0.96|||Log Rank|||||0.96|0.65|0.0190
71696077|NCT00113607|142907569|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.86||||0.0835|TWO_SIDED|95.0|0.72|1.02|||Log Rank|||||1.02|0.72|0.0835
71696078|NCT00113607|142907570|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.646||||0.008|TWO_SIDED|95.0|1.144|2.367|||Fisher Exact|||||2.367|1.144|0.0080
71696079|NCT00113607|142907571|SUPERIORITY_OR_OTHER||Hazard Ratio, log|0.95||||0.8203|TWO_SIDED|95.0|0.62|1.46|||Log Rank|||||1.46|0.62|0.8203
71696080|NCT01418339|142907585|SUPERIORITY||Treatment Difference|-4.63|||=|0.0028|TWO_SIDED|95.0|-7.62|-1.63||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-1.63|-7.62|=0.0028
71943713|NCT00358449|143408970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.3||||0.92|TWO_SIDED|95.0|-76.3|45.7|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||45.7|-76.3|0.920
71943714|NCT00358449|143408970|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-33.8||||0.105|TWO_SIDED|95.0|-79.2|11.6|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24|||11.6|-79.2|0.105
71943715|NCT00358449|143408971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.63||||0.747|TWO_SIDED|95.0|-20.68|15.41|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||15.41|-20.68|0.747
71943716|NCT00358449|143408971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7||||0.352|TWO_SIDED|95.0|-24.41|11.01|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12|||11.01|-24.41|0.352
71943717|NCT00358449|143408971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.25||||0.525|TWO_SIDED|95.0|-29.69|11.2|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 24|||11.20|-29.69|0.525
71943718|NCT00358449|143408971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.79||||0.071|TWO_SIDED|95.0|-35.21|-0.38|||Van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline at week 24|||-0.38|-35.21|0.071
71943719|NCT02589808|143408979|OTHER|||||||0.0005|||||||Kappa|||||||0.0005
71943720|NCT02163837|143408984|SUPERIORITY|the study was exploratory, the number of patients included was not calculated|||||<|0.05|||||||McNemar|||Mc Nemar symetry test for repeated measures and paired t-tests as appropriated||||<0.05
71943721|NCT01171690|143408990|SUPERIORITY_OR_OTHER|||||||0.01|TWO_SIDED||||||Matched pairs t test|||Matched pairs||||0.01
71696081|NCT01418339|142907586|SUPERIORITY||Treatment Difference|-0.52|||=|0.0124|TWO_SIDED|95.0|-0.93|-0.12||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||-0.12|-0.93|=0.0124
71696082|NCT01418339|142907587|SUPERIORITY||Treatment Difference|-2.0|||=|0.5317|TWO_SIDED|95.0|-8.31|4.32||P-value was derived from a repeated measures linear model with treatment, week, and treatment by week interaction as fixed categorical effects, the baseline value as a fixed covariate, and week as the time variable for repeated measures.|MMRM|||The statistical comparison was performed using MMRM model at a significance level of 0.05 (2-sided).||4.32|-8.31|=0.5317
71943722|NCT00105196|143409015|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.73|||<|0.001||95.0|-5.44|-2.02|||t-test, 2 sided|||The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.||-2.02|-5.44|<0.001
71943723|NCT00105196|143409016|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.075||95.0|-0.88|0.04|||t-test, 2 sided|||To protect the overall (primary and key secondary efficacy analysis) alpha level of 0.05, for this key secondary endpoint a hierarchical testing procedure was followed such that formal testing would take place conditional on the primary efficacy analysis showing a statistically significant difference.||0.04|-0.88|0.075
71943724|NCT00105196|143409017|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.052||95.0|-1.06|0.0||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.00|-1.06|0.052
71696083|NCT03093181|142907655|SUPERIORITY||Least square (LS) mean difference|3.12||||0.0128|TWO_SIDED|95.0|0.68|5.56||From Analysis of covariance (ANCOVA) with treatment main effect, age stratum and baseline as covariates|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||5.56|0.68|0.0128
71943725|NCT00105196|143409018|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.57||||0.037||95.0|-1.1|-0.03||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||-0.03|-1.10|0.037
71943726|NCT00105196|143409019|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.792||95.0|-0.67|0.51||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided|||||0.51|-0.67|0.792
71943727|NCT00105196|143409020|SUPERIORITY_OR_OTHER||Ratio of response|1.74|||<|0.001||95.0|1.31|2.32||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.32|1.31|<0.001
71943728|NCT00105196|143409021|SUPERIORITY_OR_OTHER||Ratio of response|1.43|||<|0.001||95.0|1.17|1.74||No adjustment for multiple comparisons was implemented for this secondary endpoint.|ANCOVA||aripiprazole/placebo|||1.74|1.17|<0.001
71943729|NCT00105196|143409022|SUPERIORITY_OR_OTHER||Ratio of remission|1.95|||<|0.001||95.0|1.36|2.8||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo|||2.80|1.36|<0.001
71943730|NCT01382719|143409039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0215|STANDARD_DEVIATION|2.9|<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.0|0.0|<0.05
71943731|NCT01382719|143409039|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|STANDARD_DEVIATION|0.0012|<|0.05|TWO_SIDED|95.0|0.0|0.06|||Van Elteren|||||0.06|0.00|<0.05
71943732|NCT01382719|143409040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0496|||<|0.05|||||||ANCOVA|||||||<0.05
71943733|NCT01382719|143409041|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0079|||<|0.05|TWO_SIDED|95.0|0.0|1.0|||Van Elteren|||||1.00|0.00|<0.05
71943734|NCT01382719|143409042|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0012|||<|0.05|||||||Van Elteren|||||||<0.05
71943735|NCT01382719|143409043|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0013|||<|0.05|||||||Van Elteren|||||||<0.05
71943736|NCT01382719|143409044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1161|||<|0.05|||||||Van Elteren|||||||<0.05
71943737|NCT01382719|143409045|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0133|||<|0.05|||||||ANCOVA|||||||<0.05
71943738|NCT02794974|143409147|SUPERIORITY|||||||0.236|||||||Fisher Exact|||||||0.236
71943739|NCT02794974|143409148|SUPERIORITY|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||||||0.018
71943740|NCT02794974|143409149|SUPERIORITY||Odds Ratio|4.5||||0.209|TWO_SIDED|95.0|0.63|32.2|||Odds Ratio|||||32.2|0.63|0.209
71943741|NCT02794974|143409150|SUPERIORITY||Odds Ratio|2.5||||0.44|TWO_SIDED|95.0|0.49|12.77|||Odds Ratio|||||12.77|0.49|0.44
71696084|NCT03093181|142907655|SUPERIORITY||LS mean difference|1.51||||0.2262|TWO_SIDED|95.0|-0.95|3.96||From ANCOVA with treatment main effect, age stratum and baseline as covariates.|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).|||3.96|-0.95|0.2262
71943742|NCT02794974|143409151|SUPERIORITY||Odds Ratio|1.88||||0.695|TWO_SIDED|95.0|0.37|9.45|||Odds Ratio|||||9.45|0.37|0.695
71696085|NCT03093181|142907657|SUPERIORITY||Odds Ratio (OR)|1.85||||0.0243|TWO_SIDED|95.0|1.08|3.15|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||3.15|1.08|0.0243
71696086|NCT03093181|142907657|SUPERIORITY||Odds Ratio (OR)|1.04||||0.8931|TWO_SIDED|95.0|0.61|1.78|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.||1.78|0.61|0.8931
71696087|NCT03093181|142907657|SUPERIORITY||Odds Ratio (OR)|1.9||||0.0181|TWO_SIDED|95.0|1.12|3.25|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||3.25|1.12|0.0181
71696088|NCT03093181|142907657|SUPERIORITY||Odds Ratio (OR)|0.94||||0.8319|TWO_SIDED|95.0|0.55|1.63|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.||1.63|0.55|0.8319
71696089|NCT03093181|142907658|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0279|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.28|0.02|0.0279
71696090|NCT03093181|142907658|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.8887|TWO_SIDED|95.0|-0.12|0.14|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.||0.14|-0.12|0.8887
71696091|NCT03093181|142907658|SUPERIORITY||Mean Difference (Final Values)|0.15||||0.0224|TWO_SIDED|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.28|0.02|0.0224
71696092|NCT03093181|142907658|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.8253|TWO_SIDED|95.0|-0.15|0.12|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.||0.12|-0.15|0.8253
71696093|NCT04210986|142907662|SUPERIORITY||Odds Ratio (OR)|0.99|||>|0.9|TWO_SIDED|95.0|0.25|4.02||No adjustment made for multiple comparisons.|Fisher Exact||Odds ratio is for fisetin group, relative to the placebo group.|Null hypothesis: no difference in proportion of participants experiencing any TEAE between Fisetin and Placebo groups.||4.02|0.25|>0.9
71696094|NCT04210986|142907663|SUPERIORITY||Contrast of LS Means|-3.5||||0.9728|TWO_SIDED|95.0|-10.6|3.6||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||3.6|-10.6|0.9728
71696095|NCT04210986|142907663|SUPERIORITY||Contrast of LS Means|-2.5||||0.9728|TWO_SIDED|95.0|-7.8|2.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||2.8|-7.8|0.9728
71696096|NCT04210986|142907663|SUPERIORITY||Contrast of LS Means|-20.5||||0.0829|TWO_SIDED|95.0|-37.7|-3.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||-3.3|-37.7|0.0829
71696097|NCT04210986|142907663|SUPERIORITY||Contrast of LS Means|-0.5||||0.9728|TWO_SIDED|95.0||||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Contrast of LS Means|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||||0.9728
71696098|NCT04210986|142907664|SUPERIORITY||Contrast of LS Means|2.52|||>|0.99|TWO_SIDED|95.0|-49.4|54.5||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 14 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||54.5|-49.4|>0.99
71696099|NCT04210986|142907664|SUPERIORITY||Contrast of LS Means|11.0|||>|0.99|TWO_SIDED|95.0|-36.8|58.8||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 45 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||58.8|-36.8|>0.99
71761189|NCT00611026|143024039|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71943743|NCT02996682|143409175|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
71943744|NCT02996682|143409175|SUPERIORITY||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.||||<0.001
71943745|NCT00624065|143409184|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.968||||0.8822||95.0|0.63|1.49|||Regression, Logistic|||||1.49|0.63|0.8822
71943746|NCT00904345|143409188|OTHER||||||||||||||||||Estimates of proportion event-free at 1 and 2 years calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals were calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71943747|NCT00904345|143409189|OTHER||||||||||||||||||Survival proportion estimates at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71943748|NCT00904345|143409193|OTHER||||||||||||||||||Estimates of proportion LRP event-free at 1 and 2 years were calculated using Kaplan-Meier methods, and the 2-sided, 95% confidence intervals calculated by the Greenwood method. All analyses were performed using SAS v9.4 software and R version 3.5.2.|||
71943749|NCT01629381|143409194|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.3|-0.4|||Fisher Exact|||||-0.4|-11.3|0.03
71943750|NCT01629381|143409196|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-5.3||||0.03|TWO_SIDED|95.0|-11.7|-0.1|||Fisher Exact|||||-0.1|-11.7|0.03
71943751|NCT01629381|143409197|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|-2.0||||0.53|TWO_SIDED|95.0|-8.0|3.7|||Fisher Exact|||||3.7|-8.0|0.53
71943752|NCT01390844|143409204|SUPERIORITY_OR_OTHER||Difference in Percentage|34.63|||<|0.0001|TWO_SIDED|95.0|20.24|47.18|||Miettinen and Numinen|||Between-Group Comparison||47.18|20.24|<0.0001
71943753|NCT01390844|143409205|SUPERIORITY_OR_OTHER||Difference in Percentage|33.83||||0.0063|TWO_SIDED|95.0|10.15|52.18|||Miettinen and Numinen|||Between-Group Comparison||52.18|10.15|0.0063
71943754|NCT01390844|143409206|SUPERIORITY_OR_OTHER||Difference in Percentage|35.05|||<|0.0001|TWO_SIDED|95.0|20.51|47.72|||Miettinen and Numinen|||Between-Group Comparison||47.72|20.51|<0.0001
71696100|NCT04210986|142907664|SUPERIORITY||Contrast of LS Means|-40.3||||0.6594|TWO_SIDED|95.0|-97.6|17.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||17.1|-97.6|0.6594
71943755|NCT01390844|143409207|SUPERIORITY_OR_OTHER||Difference in Percentage|33.18||||0.0086|TWO_SIDED|95.0|8.96|51.83|||Miettinen and Numinen|||Between-Group Comparison||51.83|8.96|0.0086
71943756|NCT01390844|143409208|SUPERIORITY_OR_OTHER||Difference in Percentage|29.08|||<|0.001|TWO_SIDED|95.0|15.26|42.22|||Miettinen and Nurminen|||Between-Group Comparison||42.22|15.26|<0.001
71943757|NCT01390844|143409209|SUPERIORITY_OR_OTHER||Difference in Percentage|36.13||||0.004|TWO_SIDED|95.0|12.12|55.01|||Mittienen and Nurminen|||Between-Group Comparison||55.01|12.12|0.004
71943758|NCT03693430|143409230|SUPERIORITY|Week 104 responses were analysed using an analysis of covariance model with randomised treatment as factor and baseline body weight as covariate. Missing observations were multiple (x1000) imputed from retrieved subjects of the same randomised treatment arm.|Treatment difference|-12.55|||<|0.0001|TWO_SIDED|95.0|-15.33|-9.77|||ANCOVA|||Treatment policy estimand||-9.77|-15.33|<.0001
71943759|NCT03693430|143409230|SUPERIORITY|All responses prior to first discontinuation of treatment (or initiation of other anti-obesity medication or bariatric surgery) were included in a mixed model for repeated measurements with randomised treatment as factor and baseline body weight as covariate, all nested within visit.|Treatment difference|-16.05|||<|0.0001|TWO_SIDED|95.0|-18.64|-13.45|||MMRM (Mixed model repeated measurement)|||Hypothetical estimand||-13.45|-18.64|<0.0001
71943760|NCT03693430|143409231|SUPERIORITY||Odds Ratio (OR)|4.99|||<|0.0001|TWO_SIDED|95.0|2.95|8.42|||Regression, Logistic|||Treatment policy estimand||8.42|2.95|<0.0001
71943761|NCT03693430|143409231|SUPERIORITY||Odds Ratio (OR)|18.06|||<|0.0001|TWO_SIDED|95.0|10.04|32.49|||MMRM|||Hypothetical estimand||32.49|10.04|<0.0001
71943762|NCT04185909|143409267|SUPERIORITY||||||<|0.0001|||||||Fisher Exact|||||||<.0001
71943763|NCT03567174|143409342|SUPERIORITY||Mean Difference (Net)|-0.306||||0.125|TWO_SIDED|95.0|-0.697|0.085|||Mixed Models Analysis|||||0.085|-0.697|0.125
71943764|NCT00722124|143409411|SUPERIORITY_OR_OTHER|||||||0.615||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.615
71943765|NCT00722124|143409411|SUPERIORITY_OR_OTHER|||||||0.826||95.0|||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.||||0.826
71943766|NCT03785548|143409428|OTHER||Mean Difference (Final Values)|2.851|STANDARD_ERROR_OF_MEAN|2.576||0.27|TWO_SIDED|95.0|-2.241|7.944|||ANCOVA|F(1, 140)=1.225||||7.944|-2.241|0.270
71943767|NCT03785548|143409429|OTHER||Mean Difference (Final Values)|0.141|STANDARD_ERROR_OF_MEAN|3.098||0.964|TWO_SIDED|95.0|-5.983|6.266|||ANCOVA|F(1, 140)=0.002||||6.266|-5.983|0.964
71943768|NCT01375660|143409443|SUPERIORITY_OR_OTHER|||||||0.026|TWO_SIDED||||||ANOVA|||||||0.026
71943769|NCT01375660|143409444|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||||||0.6
71943770|NCT01375660|143409445|SUPERIORITY_OR_OTHER|||||||0.389|TWO_SIDED||||||ANOVA|||||||0.389
71943771|NCT01375660|143409446|SUPERIORITY_OR_OTHER|||||||0.34|TWO_SIDED|||||P Value for Insulinogenic Index-30 = 0.34|ANOVA|||||||0.34
71943772|NCT01375660|143409447|SUPERIORITY_OR_OTHER|||||||0.22|TWO_SIDED||||||ANOVA|||||||0.22
71943773|NCT01375660|143409448|SUPERIORITY_OR_OTHER|||||||0.13|TWO_SIDED||||||Chi-squared|||||||0.13
71943774|NCT01375660|143409449|SUPERIORITY_OR_OTHER|||||||0.869|TWO_SIDED||||||Chi-squared|||||||0.869
71943775|NCT02058498|143409451|SUPERIORITY_OR_OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71943776|NCT03585790|143409454|NON_INFERIORITY|Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)||||||0.18|||||||t-test, 1 sided|||Ho: Single Vision - Multifocal \>= M vs. Ho: Single Vision - Multifocal \< M. Alpha = 0.05, two sided beta = 0.80||||0.18
71943777|NCT05327491|143409455|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.962|||||TWO_SIDED|90.0|0.88|1.053||||||||1.053|0.880|
71943778|NCT05327491|143409456|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.968|||||TWO_SIDED|90.0|0.907|1.033||||||||1.033|0.907|
71943779|NCT05327491|143409457|EQUIVALENCE|It was concluded that the test treatment is bioequivalent to the reference treatment if the 90% CI for the ratio of Geometric Least Squares Mean (GLSM) was completely contained within the predefined interval of (0.8000, 1.2500).|Ratio of GLSM|0.967|||||TWO_SIDED|90.0|0.908|1.029||||||||1.029|0.908|
71943780|NCT01171989|143409464|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.84||||||Difference in percentage anti-PRP ≥ 0.15 μg/mL||2.84|-3.27|
71943781|NCT01171989|143409465|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.27|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.27|
71943782|NCT01171989|143409465|NON_INFERIORITY|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||TWO_SIDED|95.0|-3.02|2.86||||||Difference between groups for rSBA-MenC ≥1:8||2.86|-3.02|
71943783|NCT00834743|143409522|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.49||||||90.0|90.65|109.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||109.18|90.65|
71943784|NCT00834743|143409523|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|91.44|107.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||107.19|91.44|
71943785|NCT00834743|143409524|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p\<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|90.57|108.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.|||108.32|90.57|
71943786|NCT04274686|143409585|SUPERIORITY||Mean Difference (Final Values)|1.9||||0.667|TWO_SIDED|95.0|-7.0|10.7|||Paired t-test|||Null hypothesis: No difference in percent air leakage||10.7|-7.0|0.667
71943787|NCT04274686|143409586|SUPERIORITY||Mean Difference (Final Values)|1.1||||0.218|TWO_SIDED|95.0|-0.7|2.9|||Paired t-test|||||2.90|-0.70|0.218
71943788|NCT04274686|143409587|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.455|TWO_SIDED|95.0|-0.5|0.2|||Paired t-test|||||0.2|-0.5|0.455
71943789|NCT00376623|143409588|OTHER|A one-sided exact binomial test with a 2.5 % significance level was used to detect the difference between BI 2536 and historical placebo with objective response rate = 0.9 % (two out of 211) with a 95 % confidence interval of 0.2 % to 3 %.||||||0.0548|||||||One-sided exact binomial test|Null hypothesis H0: p \<= 0.009 Alternative hypothesis HA: p \> 0.009||Efficacy of BI 2536 was evaluated by comparing the tumour response rate of the present trial with the tumour response rate published for patients with the same stage of disease treated with placebo. For this, treatment groups 'BI 2536 200 mg' and 'combination of treatment group 50 mg BI 2536 (day 1 - day 3) and 60 mg BI 2536 (day 1 - day 3)' were pooled together and compared to historical placebo.||||0.0548
71943790|NCT00376623|143409589|OTHER||Hazard Ratio (HR)|1.02||||0.92|TWO_SIDED|95.0|0.67|1.55|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.55|0.67|0.92
71943791|NCT00376623|143409590|OTHER||Hazard Ratio (HR)|1.11||||0.65|TWO_SIDED|95.0|0.7|1.78|||Log Rank||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|Exploratory analysis. No formal hypotheses were tested.||1.78|0.7|0.65
71943792|NCT00376623|143409593|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.54|||||TWO_SIDED|95.0|0.94|2.51|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.51|0.94|
71943793|NCT00376623|143409594|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|0.94|||||TWO_SIDED|95.0|0.59|1.49|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||1.49|0.59|
71943794|NCT00376623|143409595|OTHER|Exploratory analysis. No formal hypotheses were tested.|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.81|2.01|||Regression, Cox||"Hazard ratio calculated as Combination of 50 mg BI 2536 and 60 mg BI 2536 divided by 200 mg BI 2536"|||2.01|0.81|
71943795|NCT00286754|143409604|SUPERIORITY_OR_OTHER|||||||0.001|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of SMI vs. UC|Wilcoxon (Mann-Whitney)|||The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.||||0.001
71943796|NCT00286754|143409604|SUPERIORITY_OR_OTHER|||||||0.108|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.108
71943797|NCT00286754|143409605|SUPERIORITY_OR_OTHER|||||||0.009|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for SMI vs UC|Wilcoxon (Mann-Whitney)|||The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.||||0.009
71943798|NCT00286754|143409605|SUPERIORITY_OR_OTHER|||||||0.047|TWO_SIDED|||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)|||||||0.047
71943799|NCT00286754|143409606|SUPERIORITY_OR_OTHER||||||<|3e-06|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||<0.000003
71943800|NCT00286754|143409606|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.012
71943801|NCT00286754|143409606|SUPERIORITY_OR_OTHER|||||||0.89|TWO_SIDED|||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar|||||||0.89
71943802|NCT00286754|143409607|SUPERIORITY_OR_OTHER||||||<|0.009|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||<0.009
71943803|NCT00286754|143409607|SUPERIORITY_OR_OTHER|||||||0.008|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.008
71943804|NCT00286754|143409607|SUPERIORITY_OR_OTHER|||||||0.9|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.9
71696101|NCT04210986|142907664|SUPERIORITY||Contrast of LS Means|-6.9|||>|0.99|TWO_SIDED|95.0|-45.5|31.7||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||31.7|-45.5|>0.99
71943805|NCT00286754|143409608|SUPERIORITY_OR_OTHER|||||||0.88|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.880
71943806|NCT00286754|143409608|SUPERIORITY_OR_OTHER|||||||0.318|TWO_SIDED|||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)|||||||0.318
71943807|NCT00286754|143409609|SUPERIORITY_OR_OTHER|||||||0.306|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)|||||||0.306
71943808|NCT00286754|143409609|SUPERIORITY_OR_OTHER|||||||0.205|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.205
71943809|NCT00286754|143409610|SUPERIORITY_OR_OTHER|||||||0.011|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.011
71943810|NCT00286754|143409610|SUPERIORITY_OR_OTHER|||||||0.638|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.638
71943811|NCT00286754|143409611|SUPERIORITY_OR_OTHER|||||||0.012|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.012
71943812|NCT00286754|143409611|SUPERIORITY_OR_OTHER|||||||0.333|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.333
71943813|NCT00286754|143409612|SUPERIORITY_OR_OTHER|||||||0.581|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.581
71943814|NCT00286754|143409612|SUPERIORITY_OR_OTHER|||||||0.502|TWO_SIDED|||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared|||||||0.502
71943815|NCT01054586|143409624|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|6.1||||0.02||95.0|1.26|29.46||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for ART naïve. Not ART naïve is the reference group."|||29.46|1.26|0.02
71943816|NCT01054586|143409625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.12||||0.05||95.0|1.03|16.5||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||16.50|1.03|0.05
71943817|NCT01054586|143409625|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.62||||0.68||95.0|0.16|16.27||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||16.27|0.16|0.68
71943818|NCT01054586|143409626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.83||||0.17||95.0|0.65|12.36||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||12.36|0.65|0.17
71943819|NCT01054586|143409626|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.26||||0.85||95.0|0.12|13.33||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||13.33|0.12|0.85
71943820|NCT01054586|143409627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.2||||0.06||95.0|0.94|10.82||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||10.82|0.94|0.06
71943821|NCT01054586|143409627|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.06||||0.96||95.0|0.11|9.83||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p \> 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||9.83|0.11|0.96
71943822|NCT01054586|143409628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.31||||0.57||95.0|0.52|3.31||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.31|0.52|0.57
71943823|NCT01054586|143409628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.28||||0.22||95.0|0.04|2.14||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.14|0.04|0.22
71943824|NCT01054586|143409628|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.86||||0.47||95.0|0.35|9.91||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p\>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.91|0.35|0.47
71943825|NCT01054586|143409629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.4||||0.48||95.0|0.55|3.55||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||3.55|0.55|0.48
71943826|NCT01054586|143409629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.26||||0.23||95.0|0.03|2.18||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.18|0.03|0.23
71943827|NCT01054586|143409629|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.56||95.0|0.29|9.47||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p \> 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."|||9.47|0.29|0.56
71696102|NCT04210986|142907665|SUPERIORITY||Contrast of LS Means|10.5||||0.748|TWO_SIDED|95.0|-12.9|33.9||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||33.9|-12.9|0.7480
71761190|NCT00611026|143024039|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0020
71696103|NCT04210986|142907665|SUPERIORITY||Contrast of LS Means|-0.6||||0.9572|TWO_SIDED|95.0|-22.2|21.1||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||21.1|-22.2|0.9572
71696104|NCT04210986|142907666|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.47|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.47|>0.99
71696105|NCT04210986|142907666|SUPERIORITY||Contrast of LS Means|0.07|||>|0.99|TWO_SIDED|95.0|-0.33|0.47||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.47|-0.33|>0.99
71696106|NCT04210986|142907667|SUPERIORITY||Contrast of LS Means|-0.37|||>|0.99|TWO_SIDED|95.0|-1.61|0.87||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.87|-1.61|>0.99
71696107|NCT04210986|142907667|SUPERIORITY||Contrast of LS Means|0.16|||>|0.99|TWO_SIDED|95.0|-0.8|1.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.13|-0.80|>0.99
71696108|NCT04210986|142907668|SUPERIORITY||Contrast of LS Means|-0.022||||0.13|TWO_SIDED|95.0|-0.045|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.045|0.130
71696109|NCT04210986|142907668|SUPERIORITY||Contrast of LS Means|-0.024||||0.13|TWO_SIDED|95.0|-0.049|0.002||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.002|-0.049|0.130
71696110|NCT04210986|142907669|SUPERIORITY||Contrast of LS Means|-0.22||||0.9584|TWO_SIDED|95.0|-0.84|0.4||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.40|-0.84|0.9584
71943828|NCT01054586|143409631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.16||||0.72||95.0|0.51|2.66||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||2.66|0.51|0.72
71696111|NCT04210986|142907669|SUPERIORITY||Contrast of LS Means|0.12||||0.9584|TWO_SIDED|95.0|-0.69|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.69|0.9584
71943829|NCT01054586|143409631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.27||||0.21||95.0|0.03|2.08||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||2.08|0.03|0.21
71943830|NCT01054586|143409631|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.26||||0.15||95.0|0.74|6.97|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.||6.97|0.74|0.15
71696112|NCT04210986|142907670|SUPERIORITY||Contrast of LS Means|1.88||||0.5905|TWO_SIDED|95.0|-5.07|8.84||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||8.84|-5.07|0.5905
71696113|NCT04210986|142907670|SUPERIORITY||Contrast of LS Means|3.86||||0.5414|TWO_SIDED|95.0|-3.08|10.79||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||10.79|-3.08|0.5414
71696114|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.05|||>|0.99|TWO_SIDED|95.0|-0.75|0.85||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 3 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.85|-0.75|>0.99
71696115|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.44|||>|0.99|TWO_SIDED|95.0|-0.45|1.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.34|-0.45|>0.99
71696116|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.42|||>|0.99|TWO_SIDED|95.0|-0.7|1.54||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.54|-0.70|>0.99
71943831|NCT01054586|143409637|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.77||||0.1||95.0|0.79|18.05|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||18.05|0.79|0.10
71943832|NCT01054586|143409638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.53||||0.02||95.0|1.16|5.54||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.54|1.16|0.02
71943833|NCT01054586|143409638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.17||||0.05||95.0|1.54|11.27||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||11.27|1.54|0.05
71943834|NCT01054586|143409638|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.67||||0.06||95.0|0.97|13.9||Only variables showing an imbalance between the treatment groups were included, but p \> .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||13.90|0.97|0.06
71943835|NCT01054586|143409639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.68||||0.01||95.0|1.21|5.9||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||5.9|1.21|0.01
71943836|NCT01054586|143409639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|4.42||||0.0004||95.0|1.61|12.08||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||12.08|1.61|0.0004
71943837|NCT01054586|143409639|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.07||||0.11||95.0|0.78|12.03||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||12.03|0.78|0.11
71943838|NCT01054586|143409640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.09||||0.03||95.0|1.06|4.15||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||4.15|1.06|0.03
71943839|NCT01054586|143409640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|3.61||||0.05||95.0|1.48|8.81||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."|||8.81|1.48|0.05
71943840|NCT01054586|143409640|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.31||||0.1||95.0|0.85|6.32||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|||6.32|0.85|0.10
71943841|NCT01054586|143409641|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|5.12||||0.03||95.0|1.19|22.02|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."|||22.02|1.19|0.03
71943842|NCT00910663|143409649|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.01||||||90.0|90.01|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||104.55|90.01|
71943843|NCT00910663|143409650|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.81||||||90.0|100.23|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||105.45|100.23|
71943844|NCT00910663|143409651|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.35||||||90.0|100.51|106.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.|||106.27|100.51|
71943845|NCT02865850|143409652|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.31|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.53|-0.1||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||-0.10|-0.53|
71943846|NCT02865850|143409653|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per Food and Drug Administration \[FDA\]) and 1.30 (per European Medicines Agency \[EMA\]).|Hazard Ratio (HR)|0.97|||=|0.995|TWO_SIDED|95.0|0.536|1.761|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.761|0.536|=0.9950
71943847|NCT02865850|143409653|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4877|TWO_SIDED|95.0|0.833|1.113|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 355 and 377 respectively; median time to first event (Q1, Q3) = 46.14 (24.71, 77.14) weeks versus 47.00 (22.43, 74.43) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.113|0.833|=0.4877
71943848|NCT02865850|143409654|NON_INFERIORITY|Establishment of non-inferiority was based on a margin of -0.75 g/dL applied to the difference in mean change: Vadadustat minus Darbepoetin alfa.|Least squares mean difference|-0.07|STANDARD_ERROR_OF_MEAN|0.134|||TWO_SIDED|95.0|-0.34|0.19||||||Treatment comparison: Vadadustat minus Darbepoetin Alfa||0.19|-0.34|
71943849|NCT02865850|143409655|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.04|||=|0.8871|TWO_SIDED|95.0|0.618|1.743|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.743|0.618|=0.8871
71943850|NCT02865850|143409655|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.4096|TWO_SIDED|95.0|0.84|1.096|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first MACE plus hospitalization for heart failure or thromboembolic event Excluding vascular access thrombosis for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 420 and 449 respectively; median time to first event (Q1, Q3) = 42.07 (21.50, 71.14) weeks versus 45.29 (22.29, 72.43) weeks, respectively.||1.096|0.840|=0.4096
71943851|NCT02865850|143409656|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.36|||=|0.521|TWO_SIDED|95.0|0.67|2.771|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.771|0.670|=0.5210
71943852|NCT02865850|143409656|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.5007|TWO_SIDED|95.0|0.795|1.144|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular MACE for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 225 and 242 respectively; median time to first event (Q1, Q3) = 43.29 (21.71, 77.14) weeks versus 45.79 (21.14, 73.86) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.144|0.795|=0.5007
71943853|NCT02865850|143409657|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|1.1|||=|0.9527|TWO_SIDED|95.0|0.452|2.666|||Gray's test|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||2.666|0.452|=0.9527
71943854|NCT02865850|143409657|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.96|||=|0.6284|TWO_SIDED|95.0|0.766|1.195|||Gray's test|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first cardiovascular death for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 150 and 160 respectively; median time to first event (Q1, Q3) = 43.71 (27.43, 77.14) weeks versus 49.29 (24.43, 74.07) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.195|0.766|=0.6284
71943855|NCT02865850|143409658|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.78|||=|0.5115|TWO_SIDED|95.0|0.388|1.555|||Log Rank|Based on non-parametric analysis.||Statistical analysis from study AKB-6548-CI-0016 has been reported in this section.||1.555|0.388|=0.5115
71761191|NCT00611026|143024039|SUPERIORITY_OR_OTHER|||||||0.0217|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.||||0.0217
71943856|NCT02865850|143409658|NON_INFERIORITY|The prespecified non-inferiority margin was 1.25 (per FDA) and 1.30 (per EMA).|Hazard Ratio (HR)|0.95|||=|0.4878|TWO_SIDED|95.0|0.812|1.118|||Log Rank|Based on non-parametric analysis.||MACE analysis was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Time to first all-cause mortality for the Vadadustat and Darbepoetin alfa treatment groups was as follows: participants with events = 291 and 310 respectively; median time to first event (Q1, Q3) = 50.00 (29.71, 79.00) weeks versus 49.57 (25.86, 77.29) weeks, respectively. Statistical analysis from the pooled data has been reported in this section.||1.118|0.812|=0.4878
71943857|NCT02726581|143409669|SUPERIORITY||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.62|1.3||||||||1.30|0.62|
71943858|NCT02726581|143409670|SUPERIORITY||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.19||||||||1.19|0.53|
71943859|NCT02726581|143409671|SUPERIORITY||Odds Ratio (OR)|0.76|||||TWO_SIDED|95.0|0.39|1.46||||||||1.46|0.39|
71943860|NCT00552669|143409674|SUPERIORITY_OR_OTHER||||||<|0.05|||||||ANOVA|||We used One way annalysis of a variance for means and standard deviation.||||<0.05
71943861|NCT00552669|143409675|SUPERIORITY_OR_OTHER|||||||0.05|||||||Chi-squared|||Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)||||0.05
71943862|NCT00552669|143409676|SUPERIORITY_OR_OTHER||||||<|0.05|||||||Chi-squared|||"power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one."||||<0.05
71943863|NCT01844375|143409678|EQUIVALENCE|equivalence analysis||||||0.75|||||||Kruskal-Wallis|||||||0.75
71943864|NCT03020615|143409710|SUPERIORITY|||||||0.033|||||||t-test, 2 sided|||||||0.033
71943865|NCT03020615|143409713|SUPERIORITY|||||||0.0005|||||||Exact Wilcoxon (Mann-Whitley), two-sided|||||||0.0005
71943866|NCT03020615|143409715|SUPERIORITY|||||||0.011|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.011
71943867|NCT03020615|143409716|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.030
71943868|NCT03020615|143409719|SUPERIORITY|||||||0.0009|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0009
71943869|NCT03020615|143409721|SUPERIORITY|||||||0.0004|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0004
71943870|NCT03020615|143409723|SUPERIORITY|||||||0.75|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.75
71943871|NCT03020615|143409725|SUPERIORITY|||||||0.0013|||||||Exact Wilcoxon (Mann-Whitney), two-sided|||||||0.0013
71943872|NCT03020615|143409726|SUPERIORITY|||||||0.013|||||||t-test, 2 sided|||||||0.013
71943873|NCT00252720|143409743|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.024||||0.8487|TWO_SIDED|95.0|0.8|1.312|||Log Rank|Generalized||||1.312|0.800|0.8487
71943874|NCT02514122|143409777|SUPERIORITY||Mean Difference (Final Values)|0.83||||0.009|TWO_SIDED|95.0|0.29|1.9||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|t-test, 2 sided||Score was lower in the Ketamine group.|||1.9|0.29|0.009
71943875|NCT02514122|143409778|SUPERIORITY||Risk Difference (RD)|0.37|||<|0.001|TWO_SIDED|95.0|0.18|0.54|||Fisher Exact|||||.54|.18|<0.001
71943876|NCT04239872|143409779|SUPERIORITY||Mean Difference (Net)|-0.00778||||0.8412|TWO_SIDED|95.0|-0.09209|0.07653||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.07653|-0.09209|0.8412
71943877|NCT04239872|143409780|SUPERIORITY||Mean Difference (Net)|-0.06907||||0.6504|TWO_SIDED|95.0|-0.3955|0.2573||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 12 pairs of data, DF=11|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.2573|-0.3955|0.6504
71943878|NCT04239872|143409781|SUPERIORITY||Mean Difference (Net)|0.5307||||0.0024|TWO_SIDED|95.0|0.2372|0.8243||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 11 pairs of data, DF=10|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8243|0.2372|0.0024
71943879|NCT04239872|143409782|SUPERIORITY||Mean Difference (Net)|0.5643||||0.0013|TWO_SIDED|95.0|0.2938|0.8348||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 9 pairs of data, DF=8|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.8348|0.2938|0.0013
71943880|NCT04239872|143409783|SUPERIORITY||Mean Difference (Net)|-0.1135||||0.2041|TWO_SIDED|95.0|-0.2964|0.06929||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06929|-0.2964|0.2041
71943881|NCT04239872|143409784|SUPERIORITY||Mean Difference (Net)|1.095|||<|0.0001|TWO_SIDED|95.0|0.7736|1.416||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.416|0.7736|<0.0001
71943882|NCT04239872|143409785|SUPERIORITY||Mean Difference (Net)|1.469|||<|0.0001|TWO_SIDED|95.0|1.112|1.825||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.825|1.112|<0.0001
71943883|NCT04239872|143409786|SUPERIORITY||Mean Difference (Net)|1.549|||<|0.0001|TWO_SIDED|95.0|1.081|2.017||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||2.017|1.081|<0.0001
71943884|NCT04239872|143409787|SUPERIORITY||Mean Difference (Net)|-115.6||||0.5543|TWO_SIDED|95.0|-584.8|353.6||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 6 pairs of data, DF=5|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||353.6|-584.8|0.5543
71943885|NCT04239872|143409788|SUPERIORITY||Mean Difference (Net)|1.328||||0.0003|TWO_SIDED|95.0|0.842|1.814||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.814|0.8420|0.0003
71943886|NCT04239872|143409789|SUPERIORITY||Mean Difference (Net)|-0.09023||||0.2824|TWO_SIDED|95.0|-0.2613|0.08082||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.08082|-0.2613|0.2824
71943887|NCT04239872|143409790|SUPERIORITY||Mean Difference (Net)|0.6269||||0.0002|TWO_SIDED|95.0|0.3488|0.905||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.9050|0.3488|0.0002
71943888|NCT04239872|143409791|SUPERIORITY||Mean Difference (Net)|0.8946|||<|0.0001|TWO_SIDED|95.0|0.6671|1.122||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.122|0.6671|<0.0001
71943889|NCT04239872|143409792|SUPERIORITY||Mean Difference (Net)|0.973|||<|0.0001|TWO_SIDED|95.0|0.7597|1.186||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.186|0.7597|<0.0001
71943890|NCT04239872|143409793|SUPERIORITY||Mean Difference (Net)|0.9827|||<|0.0001|TWO_SIDED|95.0|0.7758|1.19||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.19|0.7758|<0.0001
71943891|NCT04239872|143409794|SUPERIORITY||Mean Difference (Net)|0.9181|||<|0.0001|TWO_SIDED|95.0|0.6573|1.179||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 19 pairs of data, DF=18|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.179|0.6573|<0.0001
71943892|NCT04239872|143409799|SUPERIORITY||Mean Difference (Net)|-0.05652||||0.3283|TWO_SIDED|95.0|-0.1762|0.06829||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 15 pairs of data, DF=14|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.06829|-0.1762|0.3283
71943893|NCT04239872|143409800|SUPERIORITY||Mean Difference (Net)|0.3411||||0.0058|TWO_SIDED|95.0|0.1189|0.5633||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5633|0.1189|0.0058
71943894|NCT04239872|143409801|SUPERIORITY||Mean Difference (Net)|0.2976||||0.0213|TWO_SIDED|95.0|0.05266|0.5426||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5426|0.05266|0.0213
71943895|NCT04239872|143409802|SUPERIORITY||Mean Difference (Net)|0.312||||0.014|TWO_SIDED|95.0|0.07454|0.5495||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.5495|0.07454|0.014
71943896|NCT04239872|143409803|SUPERIORITY||Mean Difference (Net)|0.2524||||0.1393|TWO_SIDED|95.0|-0.09153|0.5962||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.5962|-0.09153|0.1393
71943897|NCT04239872|143409804|SUPERIORITY||Mean Difference (Net)|0.2921||||0.0009|TWO_SIDED|95.0|0.1414|0.4427||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.4427|0.1414|0.0009
71943898|NCT04239872|143409805|SUPERIORITY||Mean Difference (Net)|0.2433||||0.0008|TWO_SIDED|95.0|0.1195|0.3671||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.3671|0.1195|0.0008
71943899|NCT04239872|143409806|SUPERIORITY||Mean Difference (Net)|0.3306||||0.1515|TWO_SIDED|95.0|-0.1356|0.7969||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 16 pairs of data, DF=15|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.7969|-0.1356|0.1515
71943900|NCT04239872|143409807|SUPERIORITY||Mean Difference (Net)|0.04851||||0.1712|TWO_SIDED|95.0|-0.02327|0.1203||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 17 pairs of data, DF=16|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.1203|-0.02327|0.1712
71943901|NCT04239872|143409808|SUPERIORITY||Mean Difference (Net)|0.2789||||0.1188|TWO_SIDED|95.0|-0.07934|0.6371||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 18 pairs of data, DF=17|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||0.6371|-0.07934|0.1188
71943902|NCT04239872|143409809|SUPERIORITY||Mean Difference (Net)|0.8956|||<|0.0001|TWO_SIDED|95.0|0.7205|1.071||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 14 pairs of data, DF=13|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||1.071|0.7205|<0.0001
71943903|NCT04239872|143409811|SUPERIORITY||Mean Difference (Net)|0.3199||||0.0475|TWO_SIDED|95.0|0.004686|0.6351||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 8 pairs of data, DF=7|Treatment difference of transformed (log10) data = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups. To obtain normal distribution, data used in the statistical analysis were transformed to the log10.||0.6351|0.004686|0.0475
71943904|NCT04239872|143409812|SUPERIORITY||Mean Difference (Net)|50.38||||0.0004|TWO_SIDED|95.0|27.46|73.3||The threshold for statistical significance was set at p=0.05.|t-test, 2 sided|Paired t-test was used; there were 13 pairs of data, DF=12|Treatment difference = Calcium mouthwash before fluoride mouthwash - Fluoride mouthwash|A paired t-test was used to compare the two groups.||73.30|27.46|0.0004
71943905|NCT03506386|143409891|OTHER||||||<|0.0001||||||Statistical differences among eligible performed, eligible not performed and not eligible participants were estimated by Log Rank test.|Log Rank|||||||< 0.0001
71943906|NCT01546545|143409945|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was the first pilot and feasibility study. This data will be used to power future studies.||||||0.02|||||||t-test, 2 sided|||||||0.02
71943907|NCT01546545|143409946|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|No power calculation was performed. This was a pilot and feasibility study.||||||0.02|||||||t-test, 2 sided|||||||0.02
71943908|NCT05093205|143409950|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|122.48|||||TWO_SIDED|90.0|106.96|140.25|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||140.25|106.96|
71943909|NCT05093205|143409950|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|143.83|||||TWO_SIDED|90.0|122.64|168.68|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||168.68|122.64|
71696117|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.06|||>|0.99|TWO_SIDED|95.0|-0.91|0.78||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.78|-0.91|>0.99
71696118|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.47|||>|0.99|TWO_SIDED|95.0|-1.5|0.56||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 15 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.56|-1.50|>0.99
71696119|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.19|||>|0.99|TWO_SIDED|95.0|-1.16|0.77||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.77|-1.16|>0.99
71943910|NCT05093205|143409951|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 120 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 3).|Specified in comments|104.46|||||TWO_SIDED|90.0|92.56|117.89|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||117.89|92.56|
71943911|NCT05093205|143409951|OTHER|0.15 mg LE \& 0.03 mg EE was the Reference treatment (Part B Period 1), PF-06882961 200 mg BID + 0.15 mg LE \& 0.03 mg EE was the Test treatment (Period 5).|Specified in comments|92.77|||||TWO_SIDED|90.0|81.05|106.19|||Mixed Models Analysis||A mixed effects model with treatment as a fixed effect and participant as a random effect was used was applied to calculate the ratio (Test/Reference) of adjusted means and 90% CIs for Ratio. The ratio (and 90% CI) is expressed as percentage.|||106.19|81.05|
71696120|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.19|||>|0.99|TWO_SIDED|95.0|-0.58|0.96||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 21 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.96|-0.58|>0.99
71696121|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.76|0.97||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 24 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.97|-0.76|>0.99
71761192|NCT00611026|143024039|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||<0.0001
71696122|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.01|||>|0.99|TWO_SIDED|95.0|-0.74|0.76||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 27 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.76|-0.74|>0.99
71696123|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.38|||>|0.99|TWO_SIDED|95.0|-1.2|0.44||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 30 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.44|-1.20|>0.99
71696124|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.1|||>|0.99|TWO_SIDED|95.0|-0.69|0.89||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 33 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.89|-0.69|>0.99
71696125|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-1.02|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 36 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-1.02|>0.99
71696126|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.11|||>|0.99|TWO_SIDED|95.0|-0.7|0.92||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 39 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.92|-0.70|>0.99
71696127|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.62|||>|0.99|TWO_SIDED|95.0|-1.36|0.13||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|DAY 42 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.13|-1.36|>0.99
71696128|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.23|||>|0.99|TWO_SIDED|95.0|-1.01|0.55||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 7 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.55|-1.01|>0.99
71696129|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.2|||>|0.99|TWO_SIDED|95.0|-0.89|0.49||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 8 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.49|-0.89|>0.99
71696130|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|0.02|||>|0.99|TWO_SIDED|95.0|-0.63|0.67||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 9 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.67|-0.63|>0.99
71696131|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.17|||>|0.99|TWO_SIDED|95.0|-0.95|0.61||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 10 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.61|-0.95|>0.99
71696132|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.42|||>|0.99|TWO_SIDED|95.0|-1.18|0.34||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 11 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.34|-1.18|>0.99
71696133|NCT04210986|142907671|SUPERIORITY||Contrast of LS Means|-0.35|||>|0.99|TWO_SIDED|95.0|-1.41|0.71||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|WEEK 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||0.71|-1.41|>0.99
71696134|NCT04210986|142907672|SUPERIORITY||Contrast of LS Means|1.86||||0.9106|TWO_SIDED|95.0|-3.09|6.82||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||6.82|-3.09|0.9106
71696135|NCT04210986|142907672|SUPERIORITY||Contrast of LS Means|-4.2||||0.4424|TWO_SIDED|95.0|-9.93|1.53||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||1.53|-9.93|0.4424
71696136|NCT04210986|142907672|SUPERIORITY||Contrast of LS Means|-0.03||||0.9901|TWO_SIDED|95.0|-5.55|5.48||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|MONTH 18 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.||5.48|-5.55|0.9901
71696137|NCT04210986|142907673|SUPERIORITY||Contrast of LS Means|0.69|||>|0.99|TWO_SIDED|95.0|-30.95|32.3||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 6 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||32.3|-30.95|>0.99
71696138|NCT04210986|142907673|SUPERIORITY||Contrast of LS Means|-11.3|||>|0.99|TWO_SIDED|95.0|-46.9|24.2||A priori threshold for statistical significance = 0.05. P-values adjusted for the number of post-intervention assessments via Holm-Bonferroni method.|Mixed Models Analysis|Mixed model for repeated measures (mmrm). Baseline measurement included as covariate. Random intercept and slope. Kenward-Roger DF.|Direction of Estimation Parameter: Placebo - Fisetin|"MONTH 12 ASSESSMENT. Null hypothesis: no difference in baseline-adjusted least squares means between Fisetin and Placebo groups at each post-intervention assessment.~A priori power calculation was based a standardized mean difference effect size of SMD=0.73 (Mackay, et al, 2018, Osteoarthritis and Cartilage)."||24.2|-46.9|>0.99
71696139|NCT04210986|142907674|SUPERIORITY||Hazard Ratio (HR)|0.44||||0.474|TWO_SIDED|95.0|0.05|4.21||A priori threshold for statistical significance = 0.05.|Log Rank|Cox proportional hazards model constructed. Score (log rank) test to assess between group difference in hazard rate.|Hazard ratio expresses the hazard rate of the Fisetin group in the numerator and the hazard rate of the Placebo group in the denominator|With only 4 participants that converted to an alternative treatment modality, this analysis is underpowered.||4.21|0.05|0.474
71696140|NCT02965924|142907679|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||||||<0.01
71696141|NCT01474486|142907689|OTHER|||||||0.64|||||||Mixed Models Analysis|||||||0.64
71696142|NCT04233879|142907728|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% confidence interval (95%CI) was less than 10 percentage points.|Treatment Difference|0.6|||||TWO_SIDED|95.0|-4.5|5.8|||||Unstratified Miettinen and Nurminen method was used to generate the treatment difference and the associated 95%CI.|||5.8|-4.5|
71696143|NCT04233879|142907729|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.3|||||TWO_SIDED|95.0|-0.8|9.6|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||9.6|-0.8|
71696144|NCT04233879|142907730|OTHER|Difference between treatment groups (Group 1: DOR/ISL and Group 2: BIC/FTC/TAF)|Percentage Difference|4.0|||||TWO_SIDED|95.0|0.4|7.9|||||Miettinen \& Nurminen method was used to generate percentage difference and the associated 95%CI.|||7.9|0.4|
71696145|NCT04233879|142907733|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|2.3|||||TWO_SIDED|95.0|-3.1|7.7|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||7.7|-3.1|
71696146|NCT04233879|142907734|NON_INFERIORITY|Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 10 percentage points.|Treatment Difference|1.0|||||TWO_SIDED|95.0|-4.1|6.1|||||Miettinen and Nurminen method was used to generate treatment difference and the associated 95%CI.|||6.1|-4.1|
71696147|NCT04233879|142907745|SUPERIORITY|Superiority will be concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 0.|Treatment Difference|0.15||||0.73|TWO_SIDED|95.0|-0.71|1.02|||ANCOVA|A 2-sided p-value was calculated using the Analysis of covariance (ANCOVA) model.|ANCOVA model was used to generate treatment difference and the associated 95%CI.|||1.02|-0.71|0.73
71696148|NCT03585270|142907756|SUPERIORITY||Relative Risk Reduction|0.072||||0.7338|TWO_SIDED|95.0|-0.426|0.396|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.2785).|||0.396|-0.426|0.7338
71696149|NCT03585270|142907757|SUPERIORITY||Relative Risk Reduction|0.341||||0.177|TWO_SIDED|95.0|-0.213|0.642|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8644).|||0.642|-0.213|0.177
71696150|NCT03585270|142907758|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
71696151|NCT03585270|142907759|SUPERIORITY||Relative Risk Reduction|-0.254||||0.1983|TWO_SIDED|95.0|-0.76|0.107|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.8844).|||0.107|-0.760|0.1983
71696152|NCT03585270|142907760|SUPERIORITY||Relative Risk Reduction|0.119||||0.5591|TWO_SIDED|95.0|-0.349|0.425|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1706).|||0.425|-0.349|0.5591
71696153|NCT03585270|142907761|SUPERIORITY||Relative Risk Reduction|0.267||||0.1179|TWO_SIDED|95.0|-0.085|0.505|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.4580)|||0.505|-0.085|0.1179
71696154|NCT03585270|142907762|SUPERIORITY||Relative Risk Reduction|0.139||||0.5217|TWO_SIDED|95.0|-0.365|0.457|||Cochran-Mantel-Haenszel||Homogeneity of the treatment effect across strata was investigated using the Breslow-Day test (p-value = 0.1685)|||0.457|-0.365|0.5217
71696155|NCT03292016|142907763|OTHER||Geometric Mean ratio (APL-130277/APOKYN)|12.3|||||TWO_SIDED|90.0|7.5|20.3|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||Sample size of 12 subjects, a two-sided 90% CI for the difference in paired PK parameter means on the log scale will have an interval that extends no more than 0.221 units from the observed difference with 90% coverage probability. Assumes CV of 35% for the difference on the original scale.||20.3|7.5|
71696156|NCT03292016|142907763|OTHER||Geometric Mean ratio (APL-130277/APO-go)|10.3|||||TWO_SIDED|90.0|6.5|16.3||||||||16.3|6.5|
71696157|NCT03292016|142907763|OTHER|relative bioavailibilty|Geometric Mean ratio (APOKYN/APO-go)|83.4|||||TWO_SIDED|90.0|50.5|137.6||||||||137.6|50.5|
71696158|NCT03292016|142907763|OTHER||Ratio|0.21|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
71696159|NCT03292016|142907763|OTHER||Ratio|0.13|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
71696160|NCT03292016|142907763|OTHER||Ratio|1.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
71696161|NCT03292016|142907763|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
71696162|NCT03292016|142907763|OTHER||Ratio|0.17|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
71696163|NCT03292016|142907763|OTHER||Ratio|1.12|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
71696164|NCT03292016|142907763|OTHER||Ratio|0.08|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
71696165|NCT03292016|142907763|OTHER||Ratio|0.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
71696166|NCT03292016|142907763|OTHER||Ratio|1.04|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
71696167|NCT03292016|142907764|OTHER|||||||0.0625|||||||Sign test|||||||0.0625
71696168|NCT03292016|142907764|OTHER|||||||0.0313|||||||Sign test|||||||0.0313
71696169|NCT03292016|142907764|OTHER||||||>|0.9999|||||||Sign test|||||||>0.9999
71696170|NCT03292016|142907765|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.2|||||TWO_SIDED|90.0|13.1|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.1|
71696171|NCT03292016|142907765|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|16.7|||||TWO_SIDED|90.0|13.0|21.3|||Mixed Models Analysis|||||21.3|13.0|
71696172|NCT03292016|142907765|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|96.9|||||TWO_SIDED|90.0|74.2|126.4||||||||126.4|74.2|
71696173|NCT03292016|142907765|OTHER||Ratio|0.32|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APO-Go 3 mg|||||
71696174|NCT03292016|142907765|OTHER||Ratio|0.16|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 20 mg and APOKYN 3 mg|||||
71696175|NCT03292016|142907765|OTHER||Ratio|1.09|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 3 mg and APOKYN 3 mg|||||
71696176|NCT03292016|142907765|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APO-Go 4 mg|||||
71696177|NCT03292016|142907765|OTHER||Ratio|0.23|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 25 mg and APOKYN 4 mg|||||
71696178|NCT03292016|142907765|OTHER||Ratio|1.0|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 4 mg and APOKYN 4 mg|||||
71696179|NCT03292016|142907765|OTHER||Ratio|0.15|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APO-Go 5 mg|||||
71696180|NCT03292016|142907765|OTHER||Ratio|0.14|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APL 30 mg and APOKYN 5 mg|||||
71696181|NCT03292016|142907765|OTHER||Ratio|0.96|||||||||||||The comparative bioavailability calculated as the ratio of the Test/Reference between APO-Go 5 mg and APOKYN 5 mg|||||
71696182|NCT03292016|142907766|OTHER||Geometric Mean Ratio (APL-130277/APOKYN)|17.6|||||TWO_SIDED|90.0|13.7|22.5|||Mixed Models Analysis|With fixed effects-treatment and period, random effect-subject nested within sequence to analyze natural-log transformed dose normalized parameter.||||22.5|13.7|
71696183|NCT03292016|142907766|OTHER||Geometric Mean Ratio (APL-130277/APO-go)|17.2|||||TWO_SIDED|90.0|13.7|21.6|||Mixed Models Analysis|||||21.6|13.7|
71696184|NCT03292016|142907766|OTHER||Geometric Mean Ratio (APOKYN/APO-go)|97.8|||||TWO_SIDED|90.0|76.6|124.8|||Mixed Models Analysis|||||124.8|76.6|
71696185|NCT03292016|142907771|OTHER|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||||||0.0313
71696186|NCT03292016|142907771|OTHER|||||||0.0625|||||||Wilcoxon (Mann-Whitney)|||||||0.0625
71696187|NCT03292016|142907771|OTHER||||||>|0.9999|||||||Wilcoxon (Mann-Whitney)|||||||>0.9999
71696188|NCT01791985|142907782|OTHER||Mean|0.08|STANDARD_DEVIATION|0.32|||TWO_SIDED|||||||||Proportion of change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in ER positive breast cancer patients who have progressed on treatment with either anastrozole or letrozole in any setting||||
71696189|NCT02314728|142907804|SUPERIORITY|||||||0.99|||||||Fisher Exact|||||||0.99
71696190|NCT02314728|142907805|SUPERIORITY|||||||0.6|||||||Fisher Exact|||NICU admission||||0.60
71696191|NCT02314728|142907805|SUPERIORITY|||||||0.13|||||||Fisher Exact|||histologic chorioamnionitis||||0.13
71696192|NCT03118934|142907819|NON_INFERIORITY|The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).|LSM Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.06|||ONE_SIDED|95.0||-0.1||||||||-0.1||
71696193|NCT01419314|142907841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|45.19|STANDARD_DEVIATION|20.25||0.001|TWO_SIDED|95.0|38.33|52.05|||ANOVA|Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).||A repeated measure ANOVA was performed to evaluate the contrasts of interest.||52.05|38.33|0.001
71696194|NCT01419314|142907841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.09|STANDARD_ERROR_OF_MEAN|3.6|<|0.0005|TWO_SIDED|95.0|8.8|23.39||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided||Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.|Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?||23.39|8.80|<0.0005
71696195|NCT01419314|142907841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.23|STANDARD_ERROR_OF_MEAN|5.27||0.155|TWO_SIDED|95.0|-13.93|7.47||Bonferroni adjustment for significance\<0.013.|t-test, 2 sided|df(35)|The statistical power for the between intervention contrast was calculated to be 0.26|Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.||7.47|-13.93|0.155
71696196|NCT01419314|142907841|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.67|STANDARD_ERROR_OF_MEAN|6.66||0.155|TWO_SIDED|95.0|-23.2|3.85|||t-test, 2 sided|df(35)||Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.||3.85|-23.20|0.155
71696197|NCT02100124|142907862|SUPERIORITY||Odds Ratio (OR)|0.87||||1|TWO_SIDED|95.0|0.56|1.36|||Regression, Logistic|||||1.36|0.56|1.0
71696198|NCT02100124|142907862|SUPERIORITY||Odds Ratio (OR)|1.13||||1|TWO_SIDED|95.0|0.7|1.83|||Regression, Logistic|||||1.83|0.70|1.0
71696199|NCT02100124|142907862|SUPERIORITY||Odds Ratio (OR)|1.3||||0.53|TWO_SIDED|95.0|0.82|2.08|||Regression, Logistic|||||2.08|0.82|0.53
71696200|NCT02100124|142907863|SUPERIORITY||Odds Ratio (OR)|0.88||||0.48|TWO_SIDED|95.0|0.71|1.09|||Regression, Logistic|||||1.09|0.71|0.48
71696201|NCT02100124|142907863|SUPERIORITY||Odds Ratio (OR)|1.08||||1|TWO_SIDED|95.0|0.87|1.35|||Regression, Logistic|||||1.35|0.87|1.0
71696202|NCT02100124|142907863|SUPERIORITY||Odds Ratio (OR)|1.23||||0.07|TWO_SIDED|95.0|0.99|1.53|||Regression, Logistic|||||1.53|0.99|0.07
71696203|NCT02100124|142907864|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.84|1.29|||Regression, Logistic|||||1.29|0.84|1.0
71696204|NCT02100124|142907864|SUPERIORITY||Odds Ratio (OR)|1.02||||1|TWO_SIDED|95.0|0.82|1.26|||Regression, Logistic|||||1.26|0.82|1.0
71696205|NCT02100124|142907864|SUPERIORITY||Odds Ratio (OR)|0.98||||1|TWO_SIDED|95.0|0.79|1.22|||Regression, Logistic|||||1.22|0.79|1.0
71696206|NCT02100124|142907865|SUPERIORITY||Odds Ratio (OR)|1.07||||1|TWO_SIDED|95.0|0.83|1.37|||Regression, Logistic|||||1.37|0.83|1.0
71696207|NCT02100124|142907865|SUPERIORITY||Odds Ratio (OR)|1.04||||1|TWO_SIDED|95.0|0.81|1.33|||Regression, Logistic|||||1.33|0.81|1.0
71696208|NCT02100124|142907865|SUPERIORITY||Odds Ratio (OR)|0.97||||1|TWO_SIDED|95.0|0.75|1.25|||Regression, Logistic|||||1.25|0.75|1.0
71696209|NCT01548599|142907866|SUPERIORITY||Odds Ratio, log|2.028||||0.002|TWO_SIDED|95.0|0.766|3.289|||Mixed Models Analysis|||||3.289|0.766|0.002
71696210|NCT01548599|142907867|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71696211|NCT01548599|142907868|SUPERIORITY|||||||0.013|||||||Mixed Models Analysis|||||||0.013
71696212|NCT01548599|142907869|SUPERIORITY||Odds Ratio (OR)|0.261|STANDARD_ERROR_OF_MEAN|0.398||0.378|TWO_SIDED|95.0|0.013|5.165|||Mixed Models Analysis|||||5.165|0.013|0.378
71696213|NCT01548599|142907870|SUPERIORITY||||||<|0.001|||||||Mixed Models Analysis|||||||<0.001
71696214|NCT01548599|142907871|SUPERIORITY|||||||0.398|||||||Mixed Models Analysis|||||||0.398
71696215|NCT05630196|142907872|SUPERIORITY||Posterior Mean Difference|0.39|||||TWO_SIDED|95.0|-0.22|1.0|||||Posterior mean difference with 95% credible interval is reported.|||1.00|-0.22|
71696216|NCT05630196|142907873|SUPERIORITY||Posterior Mean Difference|1.16|||||TWO_SIDED|95.0|-0.44|2.77|||||Posterior mean difference with 95% credible interval is reported.|||2.77|-0.44|
71696217|NCT05630196|142907874|SUPERIORITY||Posterior Mean Difference|0.22|||||TWO_SIDED|95.0|-0.23|0.67|||||Posterior mean difference with 95% credible interval is reported.|||0.67|-0.23|
71696218|NCT05630196|142907875|SUPERIORITY||Posterior Mean Difference|0.52|||||TWO_SIDED|95.0|-0.13|1.18|||||Posterior mean difference with 95% credible interval is reported.|||1.18|-0.13|
71696219|NCT05630196|142907876|SUPERIORITY||Posterior Mean Difference|4.2|||||TWO_SIDED|95.0|-3.51|11.87|||||Posterior mean difference with 95% credible interval is reported.|||11.87|-3.51|
71696220|NCT05630196|142907877|SUPERIORITY||Posterior Mean Difference|-0.34|||||TWO_SIDED|95.0|-0.74|0.05|||||Posterior mean difference with 95% credible interval is reported.|||0.05|-0.74|
71696221|NCT05630196|142907878|SUPERIORITY||Posterior Mean Difference|-11.11|||||TWO_SIDED|95.0|-159.85|136.77|||||Posterior mean difference with 95% credible interval is reported.|||136.77|-159.85|
71696222|NCT05630196|142907879|SUPERIORITY||Posterior Mean Difference|-0.01|||||TWO_SIDED|95.0|-0.11|0.08|||||Posterior mean difference with 95% credible interval is reported.|||0.08|-0.11|
71696223|NCT03438266|142907880|NON_INFERIORITY|If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-0.05|0.25|||||The 95% CI is based on the paired t-test.|Change from Baseline at Month 1||0.25|-0.05|
71696224|NCT03438266|142907881|OTHER||Percentage Difference|-1.7|||||TWO_SIDED|95.0|-7.31|3.98||||||||3.98|-7.31|
71696225|NCT02308046|142907891|SUPERIORITY|||||||0.002|||||||Chi-squared, Corrected|||||||0.002
71696226|NCT02308046|142907892|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||||||<0.001
71696227|NCT02308046|142907893|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 7-14 days||||<0.001
71696228|NCT02308046|142907893|SUPERIORITY||||||<|0.001|||||||Chi-squared, Corrected|||Comparison of culture cure at 21-30 days||||<0.001
71696229|NCT02308046|142907894|SUPERIORITY|||||||0.088|||||||Chi-squared, Corrected|||Comparison of the number of subjects whose reported their symptoms completely resolved||||0.088
71696230|NCT01587885|142907896|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.548|||<|0.048|||||||Regression, Cox|||||||<0.0480
71696231|NCT00752089|142907905|SUPERIORITY_OR_OTHER||Adjusted mean difference|1.146||||0.7756|TWO_SIDED|95.0|-6.904|9.196||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||9.196|-6.904|0.7756
71696232|NCT00752089|142907905|SUPERIORITY_OR_OTHER||Adjusted mean difference|3.291||||0.4194|TWO_SIDED|95.0|-4.84|11.421||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||11.421|-4.840|0.4194
71696233|NCT00752089|142907905|SUPERIORITY_OR_OTHER||Adjusted mean difference|22.2|||<|0.0001|TWO_SIDED|95.0|14.28|30.12||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||30.120|14.280|<0.0001
71696234|NCT00752089|142907905|SUPERIORITY_OR_OTHER||Adjusted mean difference|2.145||||0.5927|TWO_SIDED|95.0|-5.874|10.164||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||10.164|-5.874|0.5927
71696235|NCT00752089|142907905|SUPERIORITY_OR_OTHER||Adjusted mean difference|21.054|||<|0.0001|TWO_SIDED|95.0|13.189|28.919||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||28.919|13.189|<0.0001
71696236|NCT00752089|142907905|SUPERIORITY_OR_OTHER||Adjusted mean difference|18.909|||<|0.0001|TWO_SIDED|95.0|11.036|26.783||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||26.783|11.036|<0.0001
71696237|NCT00752089|142907906|SUPERIORITY_OR_OTHER||Adjusted mean difference|-321.438||||0.199|TWO_SIDED|95.0|-818.118|175.242||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||175.242|-818.118|0.1990
71696238|NCT00752089|142907906|SUPERIORITY_OR_OTHER||Adjusted mean difference|-72.68||||0.7718||95.0|-574.398|429.039||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||429.039|-574.398|0.7718
71696239|NCT00752089|142907906|SUPERIORITY_OR_OTHER||Adjusted mean difference|1784.675|||<|0.0001||95.0|1296.044|2273.306||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2273.306|1296.044|<0.0001
71696240|NCT00752089|142907906|SUPERIORITY_OR_OTHER||Adjusted mean difference|248.758||||0.3164||95.0|-245.962|743.478||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included tratment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||743.478|-245.962|0.3164
71696241|NCT00752089|142907906|SUPERIORITY_OR_OTHER||Adjusted mean difference|2106.113|||<|0.0001|TWO_SIDED|95.0|1620.906|2591.32||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2591.320|1620.906|<0.0001
71696242|NCT00752089|142907906|SUPERIORITY_OR_OTHER||Adjusted mean difference|1857.355|||<|0.0001|TWO_SIDED|95.0|1371.637|2343.072||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period and fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.||2343.072|1371.637|<0.0001
71696243|NCT00975416|142907924|SUPERIORITY_OR_OTHER|||||||0.927|TWO_SIDED||||||ANOVA|||Repeated measures ANOVA to deterimine whether oxytocin increased compared to placebo measures of therapeutic alliance (as measured by the Helping alliance questionnaire) pre compared to post 12 sessions of CBT.||||0.927
71696244|NCT00975416|142907924|SUPERIORITY_OR_OTHER|||||||0.6|TWO_SIDED||||||ANOVA|||Repeated measures anova to determine if oxytocin compared to placebo increased therpeutic alliance as measured by the working alliance inventory after 12 sessions of CBT.||||0.60
71696245|NCT01249131|142907940|SUPERIORITY_OR_OTHER||Ratio of Least Squares (LS) Means (in %)|94.7|||||TWO_SIDED|90.0|83.9|107.0|||||LS mean was calculated from analysis of variance (ANOVA). Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||107|83.9|
71696246|NCT01249131|142907940|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|110.0|||||TWO_SIDED|90.0|98.2|124.0|||||LS mean was calculated from ANOVA. Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).|||124|98.2|
71696247|NCT01249131|142907941|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|96.9|||||TWO_SIDED|90.0|84.2|111.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||111|84.2|
71696248|NCT01249131|142907941|SUPERIORITY_OR_OTHER||Ratio of LS Means (in %)|107.0|||||TWO_SIDED|90.0|93.8|123.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).|||123|93.8|
71696249|NCT03555149|142907947|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
71696250|NCT03555149|142907947|OTHER||Difference in Overall Response Rate|6.67|||||TWO_SIDED|95.0|-11.92|25.25|||||The difference in ORR was calculated as the experimental arm (Atezolizumab + Regorafenib + AB928) subtracted from the control arm (Regorafenib).|||25.25|-11.92|
71696251|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|1.35|||||TWO_SIDED|95.0|0.67|2.73||||||||2.73|0.67|
71696252|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|2.3|||||TWO_SIDED|95.0|1.08|4.88||||||||4.88|1.08|
71696253|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.29|2.18||||||||2.18|0.29|
71696254|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|2.0|||||TWO_SIDED|95.0|0.64|6.24||||||||6.24|0.64|
71696255|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|1.74|||||TWO_SIDED|95.0|0.83|3.63||||||||3.63|0.83|
71696256|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|0.8|||||TWO_SIDED|95.0|0.39|1.63||||||||1.63|0.39|
71696257|NCT03555149|142907948|OTHER||Hazard Ratio (HR)|5.64|||||TWO_SIDED|95.0|0.94|33.82||||||||33.82|0.94|
71696258|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.44|||||TWO_SIDED|95.0|0.71|2.93||||||Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.93|0.71|
71696259|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.38|||||TWO_SIDED|95.0|0.68|2.81||||||Atezolizumab + Isatuximab vs. Regorafenib (Control) Hazard Ratio for OS||2.81|0.68|
71696260|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.3|2.72||||||Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) Hazard Ratio for OS||2.72|0.30|
71696261|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|1.27|||||TWO_SIDED|95.0|0.42|3.84||||||Atezolizumab + Idasanutlin vs. Regorafenib (Control) Hazard Ratio for OS||3.84|0.42|
71696262|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.86|||||TWO_SIDED|95.0|0.39|1.88||||||Atezolizumab + Regorafenib vs. Regorafenib (Control) Hazard Ratio for OS||1.88|0.39|
71696263|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|0.92|||||TWO_SIDED|95.0|0.43|1.96||||||Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) Hazard Ratio for OS||1.96|0.43|
71696264|NCT03555149|142907949|OTHER|Kaplan-Meier|Hazard Ratio (HR)|2.88|||||TWO_SIDED|95.0|0.33|24.85||||||Atezolizumab + LOAd703 vs. Regorafenib (Control) Hazard Ratio for OS||24.85|0.33|
71696265|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
71696266|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-16.49|||||TWO_SIDED|95.0|-49.78|16.79||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||16.79|-49.78|
71696267|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-14.45|||||TWO_SIDED|95.0|-44.37|15.47||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||15.47|-44.37|
71696268|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-10.56|||||TWO_SIDED|95.0|-32.25|11.14||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Imprime PGG + Bevacizumab vs. Regorafenib (Control) arms||11.14|-32.25|
71696269|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-10.88|||||TWO_SIDED|95.0|-38.62|16.87||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||16.87|-38.62|
71696270|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-23.16|||||TWO_SIDED|95.0|-56.1|9.78||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||9.78|-56.10|
71696271|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-7.78|||||TWO_SIDED|95.0|-39.19|23.62||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||23.62|-39.19|
71696272|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|2.78|||||TWO_SIDED|95.0|-24.08|29.63||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Isatuximab vs. Regorafenib (Control) arms||29.63|-24.08|
71696273|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||32.19|-0.61|
71696274|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|16.84|||||TWO_SIDED|95.0|-24.39|58.07||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||58.07|-24.39|
71696275|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|18.88|||||TWO_SIDED|95.0|-34.53|72.3||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||72.30|-34.53|
71696276|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-38.19|57.08||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Selicrelumab + Bevacizumab vs. Regorafenib (Control) arms||57.08|-38.19|
71696277|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-9.21|||||TWO_SIDED|95.0|-54.7|36.28||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||36.28|-54.70|
71696278|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-13.16|||||TWO_SIDED|95.0|-66.74|40.43||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||40.43|-66.74|
71696279|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-9.45|||||TWO_SIDED|95.0|-57.26|38.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||38.36|-57.26|
71696280|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|7.78|||||TWO_SIDED|95.0|-38.18|53.73||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Idasanutlin vs. Regorafenib (Control) arms||53.73|-38.18|
71696281|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-5.24|||||TWO_SIDED|95.0|-32.03|21.56||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||21.56|-32.03|
71696282|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|8.64|||||TWO_SIDED|95.0|-23.33|40.6||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.60|-23.33|
71696283|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|5.44|||||TWO_SIDED|95.0|-29.19|40.06||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||40.06|-29.19|
71696284|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|6.71|||||TWO_SIDED|95.0|-22.64|36.06||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib vs. Regorafenib (Control) arms||36.06|-22.64|
71696285|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|2.46|||||TWO_SIDED|95.0|-21.31|26.22||||||Difference in OS event-free rate at 3 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||26.22|-21.31|
71696286|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|10.18|||||TWO_SIDED|95.0|-20.99|41.34||||||Difference in OS event-free rate at 6 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||41.34|-20.99|
71696287|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|-1.12|||||TWO_SIDED|95.0|-33.59|31.36||||||Difference in OS event-free rate at 12 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||31.36|-33.59|
71696288|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|9.44|||||TWO_SIDED|95.0|-19.06|37.94||||||Difference in OS event-free rate at 18 months for the Atezolizumab + Regorafenib + AB928 vs. Regorafenib (Control) arms||37.94|-19.06|
71696289|NCT03555149|142907950|OTHER||Difference in OS Event-Free Rate|15.79|||||TWO_SIDED|95.0|-0.61|32.19||||||Difference in OS event-free rate at 3 months for the Atezolizumab +LOAd703 vs. Regorafenib (Control) arms||32.19|-0.61|
71696290|NCT03863353|142907955|SUPERIORITY||Rebression coefficient|2.13||||0.001|TWO_SIDED|95.0|0.86|3.4||Adjusted for repeated measures and effects of covariates|Regression, Linear|||Hypothesis was tested using multivariable regression models (generalized estimating equation)||3.40|0.86|.001
71696291|NCT03863353|142907956|SUPERIORITY||Odds Ratio (OR)|1.17||||0.534|TWO_SIDED|95.0|0.72|1.9||adjusted for covariates|Regression, Logistic|||Logistic regression model examined the effect of the intervention on the outcome (collapsed intentions/behaviors)||1.90|0.72|0.534
71696292|NCT00323063|142907976|OTHER|||||||0.3|||||||Log Rank|||||||0.3
71696293|NCT01038687|142907988|SUPERIORITY|||||||0.059|||||||ANCOVA|||||||0.059
71696294|NCT01038687|142907988|SUPERIORITY|||||||0.18|||||||Dunnett's test|||15mg dose vs placebo||||0.18
71696295|NCT01038687|142907988|SUPERIORITY|||||||0.04|||||||Dunnett's test|||20mg dose vs placebo||||0.04
71696296|NCT01038687|142907989|SUPERIORITY|||||||0.81|||||||ANCOVA|||||||0.81
71696297|NCT01038687|142907989|SUPERIORITY|||||||0.89|||||||Dunnett's test|||15mg dose vs placebo||||0.89
71696298|NCT01038687|142907989|SUPERIORITY|||||||0.76|||||||Dunnett's test|||20mg dose vs placebo||||0.76
71696299|NCT01038687|142907990|SUPERIORITY|||||||0.075|||||||ANCOVA|||||||0.075
71696300|NCT01038687|142907990|SUPERIORITY|||||||0.058|||||||Dunnett's test|||15mg dose vs placebo||||0.058
71696301|NCT01038687|142907990|SUPERIORITY|||||||0.164|||||||Dunnett's test|||20mg dose vs placebo||||0.164
71696302|NCT01038687|142907991|SUPERIORITY|||||||0.084|||||||ANCOVA|||||||0.084
71696303|NCT01038687|142907991|SUPERIORITY|||||||0.98|||||||Dunnett's test|||15mg vs placebo||||0.98
71696304|NCT01038687|142907991|SUPERIORITY|||||||0.079|||||||Dunnett's test|||20mg vs placebo||||0.079
71696305|NCT01038687|142907992|SUPERIORITY|||||||0.058|||||||ANCOVA|||||||0.058
71696306|NCT01038687|142907992|SUPERIORITY|||||||0.32|||||||Dunnett's test|||15mg dose vs placebo||||0.32
71696307|NCT01038687|142907992|SUPERIORITY|||||||0.034|||||||Dunnett's test|||20mg dose vs placebo||||0.034
71696308|NCT01038687|142907993|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71696309|NCT01038687|142907993|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
71696310|NCT01038687|142907993|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg vs placebo||||0.001
71696311|NCT01038687|142907994|SUPERIORITY|||||||0.091|||||||ANCOVA|||||||0.091
71696312|NCT01038687|142907994|SUPERIORITY|||||||0.99|||||||Dunnett's test|||15mg dose vs placebo||||0.99
71696313|NCT01038687|142907994|SUPERIORITY|||||||0.103|||||||Dunnett's test|||20mg vs placebo||||0.103
71696314|NCT01038687|142907995|SUPERIORITY|||||||0.001|||||||ANCOVA|||||||0.001
71696315|NCT01038687|142907995|SUPERIORITY|||||||0.002|||||||Dunnett's test|||15mg dose vs placebo||||0.002
71696316|NCT01038687|142907995|SUPERIORITY|||||||0.001|||||||Dunnett's test|||20mg dose vs placebo||||0.001
71696317|NCT01038687|142907996|SUPERIORITY|||||||0.002|||||||ANCOVA|||||||0.002
71696318|NCT01038687|142907996|SUPERIORITY|||||||0.053|||||||Dunnett's test|||15mg dose vs placebo||||0.053
71696319|NCT01038687|142907996|SUPERIORITY|||||||0.002|||||||Dunnett's test|||20mg dose vs placebo||||0.002
71696320|NCT01076543|142908011|OTHER||Maximum tolerated dose in mg|20.0|||||TWO_SIDED||||||||"The maximum tolerated dose (MTD) was determined using the traditional 3+3 design and was the maximum dose level such that less than 33% of the patients (i.e, \<1 of 3 or \<2 of 6) experience dose-limiting toxicity."|||||
71696321|NCT01076543|142908013|SUPERIORITY||||||>|0.1|||||||Binomial exact test|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||>0.10
71696322|NCT01076543|142908013|SUPERIORITY|||||||||||||||||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 50% vs. 70% alternative.|The follicular subgroup did not reach its accrual goal and was closed.|||
71696323|NCT01076543|142908013|SUPERIORITY||||||<|0.1|||||||Binomial exact test.|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.||||<0.10
71696324|NCT05222880|142908018|SUPERIORITY|A superiority Margin of 0.00 logMAR was used for distance.|Mean Population Estimate|-0.1|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.12|-0.08||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 17 subjects were required to test the primary hypothesis for Distance.||-0.08|-0.12|
71696325|NCT05222880|142908018|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for Intermediate.|Mean Population Estimate|-0.04|STANDARD_ERROR_OF_MEAN|0.007|||TWO_SIDED|99.0|-0.06|-0.02||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 11 subjects were required to test the primary hypothesis for Intermediate.||-0.02|-0.06|
71696326|NCT05222880|142908018|SUPERIORITY|A superiority Margin of 0.17 logMAR was used for near.|Mean Population Estimate|0.07|STANDARD_ERROR_OF_MEAN|0.009|||TWO_SIDED|99.0|0.05|0.09||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% Individually) with at least 99% statistical power, that 48 subjects were required to test the primary hypothesis for Near.||0.09|0.05|
71696327|NCT05222880|142908019|SUPERIORITY|A superiority Margin of 36 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 14 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
71696328|NCT05222880|142908019|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 99% statistical power, that 18 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
71696329|NCT05222880|142908020|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0019|STANDARD_DEVIATION|0.00209|||TWO_SIDED|95.0|0.0|0.0076|||Bayesian beta- binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0076|0.0000|
71696330|NCT05222880|142908021|SUPERIORITY|A superiority margin of 0.05 was used.|Mean Proportion|0.0018|STANDARD_DEVIATION|0.0021|||TWO_SIDED|95.0|0.0|0.0078|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.02 and an intraclass correlation of 0.70 with 2000 replicating trials, that 100 subjects were required to test for superiority to achieve a minimum statistical power of 90% with 95% central posterior credible.||0.0078|0.0000|
71696331|NCT05222880|142908022|SUPERIORITY|A superiority Margin of 41 CLUE Points was used for Hyperopes.|Mean Population Estimate|52.3|STANDARD_ERROR_OF_MEAN|2.75|||TWO_SIDED|99.0|45.2|59.4||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 16 subjects were required to test for superiority for CLUE vision scores for Hyperopes.||59.4|45.2|
71696332|NCT05222880|142908022|SUPERIORITY|A superiority Margin of 46 CLUE Points was used for Myopes.|Mean Population Estimate|63.3|STANDARD_ERROR_OF_MEAN|2.054|||TWO_SIDED|99.0|58.0|68.6||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 15 subjects were required to test for superiority for CLUE vision scores for Myopes.||68.6|58.0|
71696333|NCT05222880|142908023|SUPERIORITY|A Superiority margin of 52 CLUE points was used|Mean Population Estimate|72.6|STANDARD_ERROR_OF_MEAN|1.763|||TWO_SIDED|99.0|68.1|77.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 11 subjects were required to test for superiority for CLUE comfort scores.||77.1|68.1|
71696334|NCT05222880|142908024|SUPERIORITY|A Superiority margin of 53 CLUE points was used|Mean Population Estimate|67.6|STANDARD_ERROR_OF_MEAN|1.77|||TWO_SIDED|99.0|63.0|72.1||||||It was calculated using a 2-sided one sample mean t-test with a family wise type I error rate of 5% (1% individually) with at least 80% statistical power, that 17 subjects were required to test for superiority for CLUE handling scores.||72.1|63.0|
71696335|NCT05222880|142908025|SUPERIORITY|A superiority margin of 0.90 was used.|Mean Posterior Proportion|0.985|STANDARD_DEVIATION|0.0071|||TWO_SIDED|99.0|0.959|0.997|||Bayesian beta-binomial model|Bayesian beta-binomial model for correlated binary data||It was calculated using a Bayesian beta-binomial model for correlated data with a reference rate of 0.98 and an intraclass correlation of 0.70 with 2000 replicating trials, that 92 subjects were required to test for superiority to achieve a minimum statistical power of 80% with 99% central posterior credible.||0.997|0.959|
71696336|NCT02368132|142908026|SUPERIORITY||Least squares mean difference|-8.73|STANDARD_ERROR_OF_MEAN|2.57|<|0.001|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Group Delivered TEP arm at 3 months.|||||<0.001
71696337|NCT02368132|142908026|SUPERIORITY||Least squares mean difference|-5.15|STANDARD_ERROR_OF_MEAN|2.42||0.04|TWO_SIDED||||||Mixed Models Analysis||Estimated difference in least square means between Usual Care (reference) and Individual Delivered TEP arm at 3 months.|||||0.04
71696338|NCT04232839|142908029|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.9|||||TWO_SIDED|90.0|80.3|91.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.7|80.3|
71696339|NCT04232839|142908029|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.6|||||TWO_SIDED|90.0|68.0|77.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.6|68.0|
71696340|NCT04232839|142908029|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.4|||||TWO_SIDED|90.0|86.5|98.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.8|86.5|
71696341|NCT04232839|142908029|OTHER||Adjusted geometric mean (gMean) ratio(%)|76.6|||||TWO_SIDED|90.0|71.6|81.8|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =13.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||81.8|71.6|
71696342|NCT04232839|142908029|OTHER||Adjusted geometric mean (gMean) ratio(%)|133.4|||||TWO_SIDED|90.0|117.2|151.9|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.6.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||151.9|117.2|
71696343|NCT04232839|142908029|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.2|||||TWO_SIDED|90.0|102.3|127.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.2.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||127.6|102.3|
71696344|NCT04232839|142908030|OTHER||Adjusted geometric mean (gMean) ratio(%)|85.5|||||TWO_SIDED|90.0|80.0|91.4|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||91.4|80.0|
71696345|NCT04232839|142908030|OTHER||Adjusted geometric mean (gMean) ratio(%)|72.1|||||TWO_SIDED|90.0|67.4|77.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||77.1|67.4|
71696346|NCT04232839|142908030|OTHER||Adjusted geometric mean (gMean) ratio(%)|92.2|||||TWO_SIDED|90.0|86.3|98.6|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||98.6|86.3|
71696347|NCT04232839|142908030|OTHER||Adjusted geometric mean (gMean) ratio(%)|75.5|||||TWO_SIDED|90.0|70.6|80.7|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =14.0.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'sequence', 'subjects nested within sequences', 'period', and 'treatment' (formulation). The effect 'subjects within sequences' was to be considered as random, while the other effects were to be considered as fixed.||80.7|70.6|
71696348|NCT04232839|142908030|OTHER||Adjusted geometric mean (gMean) ratio(%)|134.2|||||TWO_SIDED|90.0|117.6|153.0|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =17.9.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||153.0|117.6|
71696349|NCT04232839|142908030|OTHER||Adjusted geometric mean (gMean) ratio(%)|114.8|||||TWO_SIDED|90.0|102.9|128.1|||||Test/reference, intra-individual geometric coefficient of variance (gCV) =16.1.|Analysis of variance (ANOVA) model on the logarithmic scale, including effects accounting for 'subjects' and 'treatment'. The effect 'subjects' were to be considered as random, while the effect 'treatment' was to be considered as fixed.||128.1|102.9|
71696350|NCT00767572|142908119|SUPERIORITY_OR_OTHER||||||>|0.05||95.0||||Significance threshold p\<0.05|t-test, 2 sided|||Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin||||>0.05
71696351|NCT02084511|142908120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.39|||||TWO_SIDED|95.0|-76.3|131.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||131.1|-76.3|
71696352|NCT02084511|142908120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|53.48|||||TWO_SIDED|95.0|-50.2|157.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||157.1|-50.2|
71696353|NCT02084511|142908120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-174.61|||||TWO_SIDED|95.0|-278.3|-70.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-70.9|-278.3|
71696354|NCT02084511|142908120|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-148.53|||||TWO_SIDED|95.0|-252.4|-44.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-44.7|-252.4|
71696355|NCT02084511|142908121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.7|||||TWO_SIDED|95.0|-2.3|5.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.7|-2.3|
71696356|NCT02084511|142908121|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.98|||||TWO_SIDED|95.0|-3.0|5.0|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||5.0|-3.0|
71696357|NCT02084511|142908121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.27|||||TWO_SIDED|95.0|-10.3|-2.2|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.2|-10.3|
71696358|NCT02084511|142908121|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.98|||||TWO_SIDED|95.0|-11.0|-2.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||-2.9|-11.0|
71696359|NCT02084511|142908122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.93|||||TWO_SIDED|95.0|-16.0|27.8|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||27.8|-16.0|
71696360|NCT02084511|142908122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.58|||||TWO_SIDED|95.0|-1.3|42.5|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||42.5|-1.3|
71696361|NCT02084511|142908122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.29|||||TWO_SIDED|95.0|-35.2|8.6|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||8.6|-35.2|
71696362|NCT02084511|142908122|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.37|||||TWO_SIDED|95.0|-20.6|23.3|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term.||23.3|-20.6|
71696363|NCT02084511|142908123|SUPERIORITY_OR_OTHER|||||||0.2503|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.2503
71696364|NCT02084511|142908123|SUPERIORITY_OR_OTHER|||||||0.1851|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.1851
71696365|NCT02084511|142908123|SUPERIORITY_OR_OTHER|||||||0.0167|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0167
71696366|NCT02084511|142908124|SUPERIORITY_OR_OTHER|||||||0.415|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.4150
71696367|NCT02084511|142908124|SUPERIORITY_OR_OTHER|||||||0.3093|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.3093
71696368|NCT02084511|142908124|SUPERIORITY_OR_OTHER|||||||0.0074|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.||||0.0074
71696369|NCT01328964|142908126|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.71|||<|0.0001|TWO_SIDED|95.0|0.51|0.974||The p-value is a comparison of the combined hospitalization/emergency department visit endpoint|Regression, Cox|||||0.974|0.51|<0.0001
71696370|NCT01328964|142908127|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-14.0|||<|0.001|TWO_SIDED|95.0|-19.0|-9.0||P-value is based on the differences in the total monthly asthma costs|Regression, Linear|||||-9|-19|<0.001
71696371|NCT01328964|142908128|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.751||||0.0495|TWO_SIDED|95.0|0.565|0.999||P-value is based on the comparison of combined endpoint of hospitalization/emergency department visits|Regression, Cox|||||0.999|0.565|0.0495
71696372|NCT01328964|142908129|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-28.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-27.0||P-value is based on difference in total monthly asthma costs|Regression, Linear|||||-27|-28|<0.0001
71696373|NCT02008526|142908218|SUPERIORITY||F|1.16||||0.3137|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.3137
71696374|NCT02008526|142908219|SUPERIORITY||F|0.16||||0.8494|TWO_SIDED||||||ANOVA|2 Degrees of Freedom||||||0.8494
71761193|NCT00611026|143024039|SUPERIORITY_OR_OTHER|||||||0.0421|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0421
71761194|NCT00611026|143024039|SUPERIORITY_OR_OTHER|||||||0.0023|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.||||0.0023
71761195|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.1||0.3823|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||0.1|-0.1|0.3823
71761196|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.1||0.4802|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.1|-0.1|0.4802
71696375|NCT00492726|142908231|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.|Difference of cure rates (in percent)|-3.8||||||95.0|-7.9|0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||0.4|-7.9|
71696376|NCT00492726|142908232|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in improvement rates (in %)|1.1||||||95.0|-0.4|2.7|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||2.7|-0.4|
71696377|NCT00492726|142908233|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
71696378|NCT00492726|142908234|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-1.5||||||95.0|-5.0|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-5.0|
71696379|NCT00492726|142908235|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.0|-8.8|
71696380|NCT00492726|142908236|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.8||||||95.0|-9.0|1.5|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.5|-9.0|
71696381|NCT00492726|142908237|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-2.9||||||95.0|-7.6|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).||1.9|-7.6|
71696382|NCT00828711|142908245|SUPERIORITY_OR_OTHER||Difference in Proportions|12.2||||0.057|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure \>80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours||||0.057
71696383|NCT00828711|142908246|SUPERIORITY_OR_OTHER||Median Difference (Net)|-563.0||||0.018|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.018
71696384|NCT00828711|142908248|SUPERIORITY_OR_OTHER||Difference in Proportions|-8.46||||0.153|TWO_SIDED|95.0|||||Fisher Exact||MVI 200 - MVI 100|||||0.153
71696385|NCT00828711|142908249|SUPERIORITY_OR_OTHER||Difference in Proportions|2.37||||0.65|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||0.65
71696386|NCT00828711|142908250|SUPERIORITY_OR_OTHER||Difference in Proportions|-22.09|||<|0.001|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|||||<.001
71696387|NCT00828711|142908252|SUPERIORITY_OR_OTHER||Median Difference (Net)|-368.0||||0.007|TWO_SIDED|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdraw consent prior to delivery will be censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.||||0.007
71696388|NCT05994963|142908273|OTHER||Ratio of adjusted geometric means|58.84|||||TWO_SIDED|90.0|40.45|85.6|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||85.60|40.45|
71696389|NCT05994963|142908274|OTHER||Ratio of adjusted geometric means|56.93|||||TWO_SIDED|90.0|38.71|83.73|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||83.73|38.71|
71696390|NCT05994963|142908275|OTHER||Ratio of adjusted geometric means|50.13|||||TWO_SIDED|90.0|33.01|76.13|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment A = reference; treatment B = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||76.13|33.01|
71696391|NCT05994963|142908276|OTHER||Ratio of adjusted geometric means|202.52|||||TWO_SIDED|90.0|138.43|296.27|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||296.27|138.43|
71696392|NCT05994963|142908277|OTHER||Ratio of adjusted geometric means|196.11|||||TWO_SIDED|90.0|131.01|293.55|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||293.55|131.01|
71696393|NCT05994963|142908278|OTHER||Ratio of adjusted geometric means|230.22|||||TWO_SIDED|90.0|145.53|364.2|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment C = test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||364.20|145.53|
71696394|NCT05994963|142908279|OTHER||Ratio of adjusted geometric means|122.84|||||TWO_SIDED|90.0|93.61|161.19|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||161.19|93.61|
71696395|NCT05994963|142908280|OTHER||Ratio of adjusted geometric means|104.69|||||TWO_SIDED|90.0|94.54|115.94|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||115.94|94.54|
71696396|NCT05994963|142908281|OTHER||Ratio of adjusted geometric means|124.59|||||TWO_SIDED|90.0|93.46|166.09|||||The ratio (test/reference) and 90% CIs are expressed as percentages. Treatment B = reference; treatment D= test.|Analysis was performed using mixed effect model with sequence, period and treatment as fixed effects and participant within the sequence as a random effect.||166.09|93.46|
71696397|NCT01419535|142908292|SUPERIORITY|||||||0.6|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.60
71696398|NCT01419535|142908293|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
71696399|NCT01419535|142908294|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
71696400|NCT01419535|142908295|SUPERIORITY||||||<|0.001|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||<0.001
71696401|NCT01419535|142908296|SUPERIORITY|||||||0.004|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.004
71696402|NCT01419535|142908297|SUPERIORITY|||||||0.002|||||||ANOVA|Repeated measures were analyzed by repeated-measures ANOVA including treatment group, time, and treatment\*time interaction as factors.||||||0.002
71696403|NCT01181167|142908322|NON_INFERIORITY_OR_EQUIVALENCE|"Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.~Incidence of thromboembolic events and 95% CI also calculated by treatment group.~Only when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE."|Cox Proportional Hazard|-4.5|||<|0.001|ONE_SIDED|95.0||||Farrington Manning Method|ANCOVA|||Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU \< P˅E + Δ (significance level: One-sided, 0.025)||||<0.001
71696404|NCT00408499|142908349|OTHER|Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.|Maximum tolerated dose|4.0|||||TWO_SIDED||||||||Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab|||||
71696405|NCT02683109|142908368|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of the Tio+Olo FDC versus the Tio/Olo free combination was tested at the one-sided α-level of 0.025 using a non-inferiority margin of 0.1 L.|Adjusted mean|0.024|STANDARD_ERROR_OF_MEAN|0.022|<|0.0001|TWO_SIDED|95.0|-0.02|0.067|||ANCOVA|||The primary analysis was conducted using an Analysis of Covariance \[ANCOVA\] model including treatment as fixed categorical effect and baseline as continuous covariate.||0.067|-0.020|<0.0001
71696406|NCT02683109|142908369|SUPERIORITY_OR_OTHER||Adjusted mean|0.006|STANDARD_ERROR_OF_MEAN|0.034||0.8648|TWO_SIDED|95.0|-0.061|0.073|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.073|-0.061|0.8648
71696407|NCT02683109|142908370|SUPERIORITY_OR_OTHER||Adjusted mean|-0.327|STANDARD_ERROR_OF_MEAN|0.536||0.542|TWO_SIDED|95.0|-1.384|0.729|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.||0.729|-1.384|0.5420
71696408|NCT00526474|142908420|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.001|TWO_SIDED|95.0|0.82|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.82|0.001
71696409|NCT00526474|142908421|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.8|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.80|<0.001
71696410|NCT00526474|142908422|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.51|||<|0.001|TWO_SIDED|95.0|1.31|1.74|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.74|1.31|<0.001
71696411|NCT00526474|142908423|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.41|||<|0.001|TWO_SIDED|95.0|1.31|1.51|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.51|1.31|<0.001
71696412|NCT00526474|142908424|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.009|TWO_SIDED|95.0|0.85|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.85|0.009
71696413|NCT00526474|142908425|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.002|TWO_SIDED|95.0|0.78|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.78|0.002
71696414|NCT00526474|142908426|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.87|||<|0.001|TWO_SIDED|95.0|0.81|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.81|<0.001
71696415|NCT00526474|142908427|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.91||||0.001|TWO_SIDED|95.0|0.86|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.86|0.001
71696416|NCT00526474|142908428|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.9|||<|0.001|TWO_SIDED|95.0|0.85|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.85|<0.001
71696417|NCT00526474|142908429|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.151|TWO_SIDED|95.0|0.76|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.76|0.151
71696418|NCT00526474|142908430|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
71696419|NCT00526474|142908431|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.108|TWO_SIDED|95.0|0.75|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.75|0.108
71696420|NCT00526474|142908432|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.97||||0.733|TWO_SIDED|95.0|0.83|1.14|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.14|0.83|0.733
71696421|NCT00526474|142908433|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.95||||0.411|TWO_SIDED|95.0|0.85|1.07|||Cox Proportional Hazards Regression||Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.07|0.85|0.411
71696422|NCT00526474|142908434|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83||||0.001|TWO_SIDED|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.74|0.001
71696423|NCT00526474|142908435|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
71696424|NCT00526474|142908436|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.76|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.76|<0.001
71696425|NCT00526474|142908437|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.8|||<|0.001|TWO_SIDED|95.0|0.73|0.89|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.89|0.73|<0.001
71696426|NCT00526474|142908438|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.45|||<|0.001|TWO_SIDED|95.0|1.23|1.71|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.71|1.23|<0.001
71696427|NCT00526474|142908439|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|1.42|||<|0.001|TWO_SIDED|95.0|1.31|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.54|1.31|<0.001
71696428|NCT00526474|142908440|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86|||<|0.001|TWO_SIDED|95.0|0.79|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.79|<0.001
71696429|NCT00526474|142908441|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.75|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.75|<0.001
71696430|NCT00526474|142908442|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.83|||<|0.001|TWO_SIDED|95.0|0.77|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.90|0.77|<0.001
71696431|NCT00526474|142908443|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89|||<|0.001|TWO_SIDED|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.95|0.83|<0.001
71696432|NCT00526474|142908444|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88|||<|0.001|TWO_SIDED|95.0|0.83|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.94|0.83|<0.001
71696433|NCT00526474|142908445|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.108|TWO_SIDED|95.0|0.71|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.03|0.71|0.108
71696434|NCT00526474|142908446|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.82||||0.002|TWO_SIDED|95.0|0.73|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.93|0.73|0.002
71696435|NCT00526474|142908447|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.88||||0.127|TWO_SIDED|95.0|0.74|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.04|0.74|0.127
71696436|NCT00526474|142908448|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.67||||0.002|TWO_SIDED|95.0|0.52|0.87|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.87|0.52|0.002
71696437|NCT00526474|142908449|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.92||||0.249|TWO_SIDED|95.0|0.8|1.06|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||1.06|0.80|0.249
71696438|NCT00526474|142908450|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.86||||0.019|TWO_SIDED|95.0|0.76|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.98|0.76|0.019
71696439|NCT00526474|142908451|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.89||||0.003|TWO_SIDED|95.0|0.83|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio \<1 would indicate a lower hazard associated with vorapaxar relative to placebo.|||0.96|0.83|0.003
71696440|NCT03845894|142908452|NON_INFERIORITY|There have been no studies to evaluate pain scores ISB w/ plain bupi+adjuvants. Power to detect difference at least 0.4 on the VAS scale. Threshold for inferiority is difference \>=2 points on the VAS scale. Will use two-sample t test with α= 0.05 and β= 0.1. Postop opioid consumption, total post-op opioid @ 1st 48 hours in oxycodone equivalents. Mean opioid consumption per cohort is calculated, \& the cohorts compared for statistical difference with two-sample t test, with α= 0.05 and β= 0.1.||||||0.14|||||||Wilcoxon (Mann-Whitney)|||||||0.14
71696441|NCT02709746|142908476|SUPERIORITY||Mean Difference (Final Values)|1.13||||0.4702|TWO_SIDED|95.0|-1.94|4.2|||Mixed Model Repeated Analysis|||||4.2|-1.94|0.4702
71696442|NCT02709746|142908476|SUPERIORITY||Mean Difference (Final Values)|-0.72||||0.6373|TWO_SIDED|95.0|-3.71|2.27|||Mixed Model Repeated Analysis|||||2.27|-3.71|0.6373
71696443|NCT02709746|142908476|SUPERIORITY||Mean Difference (Final Values)|-3.73||||0.0152|TWO_SIDED|95.0|-6.74|-0.72|||Mixed Model Repeated Analysis|||||-0.72|-6.74|0.0152
71696444|NCT02709746|142908476|SUPERIORITY||Mean Difference (Final Values)|0.21||||0.8778|TWO_SIDED|95.0|-2.41|2.82|||Mixed Model Repeated Analysis|||||2.82|-2.41|0.8778
71696445|NCT00644059|142908544|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|97.66|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
71696446|NCT00644059|142908547|SUPERIORITY_OR_OTHER||Vaccine Efficacy|81.36|||||TWO_SIDED|95.0|49.24|93.16|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||93.16|49.24|
71696447|NCT00644059|142908547|SUPERIORITY_OR_OTHER||Vaccine Efficacy|95.5|||||TWO_SIDED|95.0|80.92|98.94|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||98.94|80.92|
71696448|NCT00644059|142908547|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.32|||||TWO_SIDED|95.0|0.13|0.73|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.73|0.13|
71696449|NCT00644059|142908547|SUPERIORITY_OR_OTHER||Vaccine Efficacy|0.09|||||TWO_SIDED|95.0|0.02|0.38|||Mantel Haenszel|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||0.38|0.02|
71696450|NCT00644059|142908548|SUPERIORITY_OR_OTHER||vaccine Efficacy|79.18|||||TWO_SIDED|95.0|54.78|90.42|||Poisson Regression Model|||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"||90.42|54.78|
71696451|NCT00644059|142908548|SUPERIORITY_OR_OTHER||Vaccine Efficacy|92.1|||||TWO_SIDED|95.0|77.35|97.24|||Poisson Regression Model|||Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)||97.24|77.35|
71696452|NCT00644059|142908548|SUPERIORITY_OR_OTHER||Vaccine Efficacy|64.16|||||TWO_SIDED|95.0|23.21|83.28|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||83.28|23.21|
71696453|NCT00644059|142908548|SUPERIORITY_OR_OTHER||Vaccine Efficacy|85.66|||||TWO_SIDED|95.0|58.95|94.99|||Poisson Regression Model|||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.||94.99|58.95|
71696454|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|0.83|||||TWO_SIDED|95.0|0.67|1.02|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.02|0.67|
71696455|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|7.63|||||TWO_SIDED|95.0|5.42|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.42|
71696456|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|15.0|||||TWO_SIDED|95.0|11.0|21.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||21|11|
71696457|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H1N1)]|6.48|||||TWO_SIDED|95.0|4.83|8.68|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay||8.68|4.83|
71696458|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|1.01|||||TWO_SIDED|95.0|0.85|1.21|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.21|0.85|
71696459|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|9.82|||||TWO_SIDED|95.0|7.76|12.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||12|7.76|
71696460|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|16.0|||||TWO_SIDED|95.0|12.0|20.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||20|12|
71696461|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Brisbane/2007 (A/H3N2)]|4.92|||||TWO_SIDED|95.0|3.64|6.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||6.65|3.64|
71696462|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.0|||||TWO_SIDED|95.0|0.91|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.91|
71696463|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|1.5|||||TWO_SIDED|95.0|1.19|1.9|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.9|1.19|
71696464|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|6.99|||||TWO_SIDED|95.0|5.72|8.53|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||8.53|5.72|
71696465|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[B/Florida/2006]|2.92|||||TWO_SIDED|95.0|2.44|3.5|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||3.5|2.44|
71696466|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.81|||||TWO_SIDED|95.0|0.64|1.04|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.04|0.64|
71696467|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|1.21|||||TWO_SIDED|95.0|0.83|1.78|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.78|0.83|
71696468|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1]|7.54|||||TWO_SIDED|95.0|5.33|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||11|5.33|
71696469|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Solomon Islands/2006 (A/H1N1)]|3.31|||||TWO_SIDED|95.0|2.4|4.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.55|2.4|
71696470|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.9|||||TWO_SIDED|95.0|0.74|1.1|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.1|0.74|
71696471|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT[A/Wisconsin/2009 (A/H3N2)]|3.54|||||TWO_SIDED|95.0|2.78|4.51|||GMT|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.51|2.78|
71696472|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|13.0|||||TWO_SIDED|95.0|10.0|16.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||16|10|
71696473|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.6|||||TWO_SIDED|95.0|2.61|4.95|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||4.95|2.61|
71696474|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|1.0|1.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1|1|
71696475|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.06|||||TWO_SIDED|95.0|1.02|1.11|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.11|1.02|
71696476|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.74|||||TWO_SIDED|95.0|1.57|1.92|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.92|1.57|
71696477|NCT00644059|142908554|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.92|1.08|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.||1.08|0.92|
71696478|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.78|1.19|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.19|0.78|
71696479|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|6.41|||||TWO_SIDED|95.0|4.69|8.76|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.76|4.69|
71696480|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|8.26|||||TWO_SIDED|95.0|6.36|11.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||11|6.36|
71696481|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H1N1)]|4.37|||||TWO_SIDED|95.0|3.38|5.65|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.65|3.38|
71696482|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \<72 months by HI assay.||1.35|0.82|
71696483|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|6.42|||||TWO_SIDED|95.0|4.72|8.73|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||8.73|4.72|
71696484|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|7.98|||||TWO_SIDED|95.0|6.2|10.0|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||10|6.2|
71696485|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Brisbane/2007 (A/H3N2)]|3.13|||||TWO_SIDED|95.0|2.42|4.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.05|2.42|
71696486|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|0.97|||||TWO_SIDED|95.0|0.9|1.05|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.05|0.9|
71696487|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|1.56|||||TWO_SIDED|95.0|1.26|1.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.93|1.26|
71696488|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|5.0|||||TWO_SIDED|95.0|4.25|5.88|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||5.88|4.25|
71696489|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Florida/2006]|2.55|||||TWO_SIDED|95.0|2.22|2.93|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.93|2.22|
71696490|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.96|||||TWO_SIDED|95.0|0.75|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|0.75|
71696491|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|1.72|||||TWO_SIDED|95.0|1.17|2.51|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||2.51|1.17|
71696492|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|5.58|||||TWO_SIDED|95.0|4.08|7.63|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||7.63|4.08|
71696493|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Solomon Islands/2006 (A/H1N1)]|3.11|||||TWO_SIDED|95.0|2.3|4.2|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.2|2.3|
71696494|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|0.98|||||TWO_SIDED|95.0|0.74|1.3|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.3|0.74|
71696495|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|3.14|||||TWO_SIDED|95.0|2.19|4.49|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||4.49|2.19|
71696496|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|7.36|||||TWO_SIDED|95.0|5.51|9.82|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||9.82|5.51|
71696497|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [A/Wisconsin/2009 (A/H3N2)]|2.66|||||TWO_SIDED|95.0|2.0|3.55|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||3.55|2|
71696498|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.0|||||TWO_SIDED|95.0|0.98|1.01|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.01|0.98|
71696499|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.13|||||TWO_SIDED|95.0|1.05|1.22|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.22|1.05|
71696500|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.79|||||TWO_SIDED|95.0|1.63|1.97|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.97|1.63|
71696501|NCT00644059|142908557|SUPERIORITY_OR_OTHER||GMT [B/Brisbane/2008]|1.08|||||TWO_SIDED|95.0|1.0|1.17|||ANOVA|||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.||1.17|1|
71696502|NCT02497469|142908575|SUPERIORITY||Adjusted Difference|8.8||||0.0061|TWO_SIDED|95.0|2.5|15.0|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|15.0|2.5|0.0061
71696503|NCT02497469|142908576|SUPERIORITY||Adjusted Difference|11.9||||0.0005|TWO_SIDED|95.0|5.3|18.5|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|18.5|5.3|0.0005
71696504|NCT02497469|142908577|SUPERIORITY||Adjusted Difference|-9.3||||0.0641|TWO_SIDED|95.0|-18.9|0.4|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was \<=5.|0.4|-18.9|0.0641
71696505|NCT01614470|142908689|SUPERIORITY_OR_OTHER||Least squares (LS) mean difference|10.678|||<|0.0001|TWO_SIDED|95.0|7.2559|14.1|||Mixed Models Analysis|||||14.1000|7.2559|<0.0001
71696506|NCT01614470|142908690|SUPERIORITY_OR_OTHER||LS mean difference|0.6624|||<|0.0001|TWO_SIDED|95.0|0.3366|0.9881|||Mixed Models Analysis|||||0.9881|0.3366|<0.0001
71696507|NCT01614470|142908692|SUPERIORITY_OR_OTHER||LS mean difference|-49.1667|||<|0.0001|TWO_SIDED|95.0|-56.9527|-41.3807|||Mixed Models Analysis|||||-41.3807|-56.9527|<0.0001
71696508|NCT01614470|142908695|SUPERIORITY_OR_OTHER||LS mean difference|9.6105||||0.0004|TWO_SIDED|95.0|4.4874|14.7336|||Mixed Models Analysis|||||14.7336|4.4874|0.0004
71696509|NCT03217591|142908700|SUPERIORITY||Geometric mean change (%)|-16.0|||=|0.2142|TWO_SIDED|90.0|-33.3|5.8|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 20 mg. Geometric mean change (%) and the associated confidence intervals (CIs) were derived as 100×\[exp(Least Squares Mean Change)-1\].||5.8|-33.3|=0.2142
71696510|NCT03217591|142908700|SUPERIORITY||Geometric mean change (%)|-14.6|||=|0.2718|TWO_SIDED|90.0|-32.7|8.3|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat 40 mg. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||8.3|-32.7|=0.2718
71696511|NCT03217591|142908700|SUPERIORITY||Geometric mean change (%)|-15.3|||=|0.1736|TWO_SIDED|90.0|-30.7|3.6|||Mixed Models Analysis|||Treatment comparison between placebo and praliciguat overall. Geometric mean change (%) and the associated CIs were derived as 100×\[exp(Least Squares Mean Change)-1\].||3.6|-30.7|=0.1736
71696512|NCT00269152|142908710|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|59.4|||||TWO_SIDED|95.0|46.4|71.5||||||||71.5|46.4|
71696513|NCT00269152|142908710|SUPERIORITY_OR_OTHER||Feasibility Response Rate (percentage)|50.0||||||95.0|36.1|63.9||||||||63.9|36.1|
71696514|NCT04249427|142908715|EQUIVALENCE|Test if the change in mean number of days with significant mid-facial pain in Erenuman group differs from that in Placebo group.||||||0.96|||||||ANOVA|||||||0.96
71696515|NCT04249427|142908716|EQUIVALENCE|Test if the change in SNOT-22 score in Erenuman group differs from that in Placebo group.||||||0.19|||||||ANOVA|||||||0.19
71696516|NCT04249427|142908717|EQUIVALENCE|Test if the change in Physical Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.06|||||||ANOVA|||||||0.06
71696517|NCT04249427|142908718|EQUIVALENCE|Test if the change in Usual Activities as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.08|||||||Wilcoxon (Mann-Whitney)|||||||0.08
71696518|NCT04249427|142908719|EQUIVALENCE|Test if the change in Social Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.058|||||||ANOVA|||||||0.058
71696519|NCT04249427|142908720|EQUIVALENCE|Test if the change in Emotional Function as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.02|||||||ANOVA|||||||0.02
71696520|NCT04249427|142908721|EQUIVALENCE|Test if the change in Overall Impact (global) as Measured by Migraine Function Impact in Erenuman group differs from that in Placebo group.||||||0.0036|||||||ANOVA|||||||0.0036
71696521|NCT04249427|142908722|EQUIVALENCE|Test if the change of average number of days per month with significant nasal congestion in Erenuman group differs from that in Placebo group.||||||0.83|||||||ANOVA|||||||0.83
71696522|NCT04249427|142908723|EQUIVALENCE|Test if the change of average number of days per month with significant significant rhinorrhea in Erenuman group differs from that in Placebo group||||||0.83|||||||ANOVA|||||||0.83
71696523|NCT04249427|142908724|EQUIVALENCE|Test if the change in doses of rescue pain medications in Erenuman group differs from that in Placebo group.||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71696524|NCT04249427|142908725|EQUIVALENCE|Test if the change from baseline in mean daily pain score in Erenuman group differs from that in Placebo group.||||||0.85|||||||Wilcoxon (Mann-Whitney)|||||||0.85
71696525|NCT02557399|142908726|SUPERIORITY_OR_OTHER||difference in percent|-6.83||||0.008|TWO_SIDED|95.0|-11.88|-1.78||The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.78|-11.88|0.008
71696526|NCT02557399|142908727|SUPERIORITY_OR_OTHER||difference in percent|-0.25||||0.916|TWO_SIDED|95.0|-4.85|4.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1|||4.35|-4.85|0.916
71696527|NCT02557399|142908727|SUPERIORITY_OR_OTHER||difference in percent|-5.85||||0.01|TWO_SIDED|95.0|-10.29|-1.42||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4|||-1.42|-10.29|0.010
71696528|NCT02557399|142908727|SUPERIORITY_OR_OTHER||difference in percent|-2.35||||0.257|TWO_SIDED|95.0|-6.42|1.72||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8|||1.72|-6.42|0.257
71696529|NCT02557399|142908727|SUPERIORITY_OR_OTHER||difference in percent|-3.24||||0.062|TWO_SIDED|95.0|-6.64|0.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12|||0.16|-6.64|0.062
71696530|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-5.08||||0.115|TWO_SIDED|95.0|-11.41|1.25||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.25|-11.41|0.115
71696531|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-8.43||||0.005|TWO_SIDED|95.0|-14.35|-2.51||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.51|-14.35|0.005
71696532|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-9.37|||<|0.001|TWO_SIDED|95.0|-14.42|-4.33||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-4.33|-14.42|<0.001
71696533|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-6.69||||0.004|TWO_SIDED|95.0|-11.21|-2.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-2.16|-11.21|0.004
71696534|NCT02557399|142908728|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.5||||0.015|TWO_SIDED|95.0|-8.1|-0.89||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs|||-0.89|-8.10|0.015
71696535|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|2.71||||0.382|TWO_SIDED|95.0|-3.38|8.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||8.80|-3.38|0.382
71696536|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-5.69||||0.085|TWO_SIDED|95.0|-12.17|0.78||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.78|-12.17|0.085
71696537|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-3.89||||0.186|TWO_SIDED|95.0|-9.67|1.88||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.88|-9.67|0.186
71696538|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-0.59||||0.818|TWO_SIDED|95.0|-5.61|4.44||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.44|-5.61|0.818
71696539|NCT02557399|142908728|SUPERIORITY_OR_OTHER||difference in percent|-3.78||||0.073|TWO_SIDED|95.0|-7.92|0.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.35|-7.92|0.073
71696540|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.1||||0.961|TWO_SIDED|95.0|-4.6|4.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.4|-4.6|0.961
71696541|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-6.2||||0.015|TWO_SIDED|95.0|-11.2|-1.2||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.2|-11.2|0.015
71696542|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-4.7||||0.044|TWO_SIDED|95.0|-9.2|-0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.1|-9.2|0.044
71696543|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.747|TWO_SIDED|95.0|-4.9|3.5||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||3.5|-4.9|0.747
71696544|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.7||||0.338|TWO_SIDED|95.0|-5.3|1.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.8|-5.3|0.338
71696545|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.8||||0.068|TWO_SIDED|95.0|-3.8|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-3.8|0.068
71696546|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.002|TWO_SIDED|95.0|-4.8|-1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.1|-4.8|0.002
71696547|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.6||||0.002|TWO_SIDED|95.0|-4.3|-1.0||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-1.0|-4.3|0.002
71696548|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.9||||0.012|TWO_SIDED|95.0|-3.4|-0.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.4|-3.4|0.012
71696549|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.078|TWO_SIDED|95.0|-2.4|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.1|-2.4|0.078
71696550|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.8||||0.367|TWO_SIDED|95.0|-2.1|5.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||5.7|-2.1|0.367
71696551|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.1||||0.148|TWO_SIDED|95.0|-7.4|1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.1|-7.4|0.148
71696552|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.0||||0.314|TWO_SIDED|95.0|-5.9|1.9||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||1.9|-5.9|0.314
71761197|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.0||0.8355|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.||0.1|-0.1|0.8355
71696553|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2||||0.494|TWO_SIDED|95.0|-2.3|4.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||4.7|-2.3|0.494
71696554|NCT02557399|142908729|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6||||0.684|TWO_SIDED|95.0|-3.5|2.3||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||2.3|-3.5|0.684
71696555|NCT02557399|142908730|SUPERIORITY_OR_OTHER||Difference in percentage|2.3||||0.047|TWO_SIDED|95.0|0.1|4.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.6|0.1|0.047
71696556|NCT02557399|142908730|SUPERIORITY_OR_OTHER||Difference in percentage|3.0||||0.185|TWO_SIDED|95.0|-1.3|7.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.3|-1.3|0.185
71696557|NCT02557399|142908730|SUPERIORITY_OR_OTHER||Difference in percentage|3.7||||0.251|TWO_SIDED|95.0|-2.5|9.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.9|-2.5|0.251
71696558|NCT02557399|142908730|SUPERIORITY_OR_OTHER||Difference in percentage|10.2||||0.006|TWO_SIDED|95.0|2.4|18.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||18.0|2.4|0.006
71696559|NCT02557399|142908730|SUPERIORITY_OR_OTHER||Difference in percentage|10.7||||0.022|TWO_SIDED|95.0|0.9|20.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.4|0.9|0.022
71696560|NCT02557399|142908731|SUPERIORITY_OR_OTHER||Difference in percentage|1.8||||0.129|TWO_SIDED|95.0|-0.7|4.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||4.3|-0.7|0.129
71696561|NCT02557399|142908731|SUPERIORITY_OR_OTHER||Difference in percentage|1.3||||0.612|TWO_SIDED|95.0|-3.4|5.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.9|-3.4|0.612
71696562|NCT02557399|142908731|SUPERIORITY_OR_OTHER||Difference in percentage|7.1||||0.016|TWO_SIDED|95.0|1.1|13.2||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.2|1.1|0.016
71696563|NCT02557399|142908731|SUPERIORITY_OR_OTHER||Difference in percentage|7.9||||0.034|TWO_SIDED|95.0|0.3|15.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.5|0.3|0.034
71696564|NCT02557399|142908731|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.018|TWO_SIDED|95.0|1.4|21.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||21.3|1.4|0.018
71696565|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.379|TWO_SIDED|95.0|-4.5|12.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||12.3|-4.5|0.379
71696566|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|4.7||||0.409|TWO_SIDED|95.0|-5.7|15.1||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||15.1|-5.7|0.409
71696567|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|7.0||||0.18|TWO_SIDED|95.0|-3.1|17.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||17.0|-3.1|0.180
71696568|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|-0.5||||0.81|TWO_SIDED|95.0|-8.8|7.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||7.7|-8.8|0.810
71696569|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|1.9||||0.648|TWO_SIDED|95.0|-5.2|9.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||9.0|-5.2|0.648
71696570|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|9.1||||0.048|TWO_SIDED|95.0|-1.3|19.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||19.6|-1.3|0.048
71696571|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|11.2||||0.016|TWO_SIDED|95.0|1.8|20.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||20.6|1.8|0.016
71696572|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|8.6||||0.044|TWO_SIDED|95.0|0.4|16.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||16.9|0.4|0.044
71696573|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|3.6||||0.345|TWO_SIDED|95.0|-3.8|11.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||11.0|-3.8|0.345
71696574|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|2.6||||0.424|TWO_SIDED|95.0|-3.5|8.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.7|-3.5|0.424
71696575|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|-2.0||||0.527|TWO_SIDED|95.0|-9.4|5.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||5.5|-9.4|0.527
71696576|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|3.3||||0.584|TWO_SIDED|95.0|-6.7|13.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||13.4|-6.7|0.584
71696577|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|3.9||||0.519|TWO_SIDED|95.0|-6.5|14.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||14.3|-6.5|0.519
71696578|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Difference in percentage|-0.8||||0.766|TWO_SIDED|95.0|-10.1|8.5||The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||8.5|-10.1|0.766
71696579|NCT02557399|142908732|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.3||||0.666|TWO_SIDED|95.0|-5.8|10.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.|||10.5|-5.8|0.666
71696580|NCT02557399|142908736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
71696581|NCT02557399|142908736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.017|TWO_SIDED|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.04|-0.40|0.017
71696582|NCT02557399|142908736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.22||||0.024|TWO_SIDED|95.0|-0.41|-0.03|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||-0.03|-0.41|0.024
71696583|NCT02557399|142908736|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.17||||0.08|TWO_SIDED|95.0|-0.36|0.02|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|||0.02|-0.36|0.080
71696584|NCT02848664|142908740|OTHER|Same DOSS score before and after device use for 3 months or improved DOSS score after device use for 3 months|||||<|0.025||||||p values adjusted for multiple comparisons (two outcome measures)|Wilcoxon (Mann-Whitney)|||Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.||||<0.025
71696585|NCT02848664|142908741|EQUIVALENCE|Examination of whether the level of swallowing handicap is changed following device use|Mean Difference (Net)|22.571||||0.016|TWO_SIDED|95.0|6.003|39.14|||t-test, 2 sided|||||39.140|6.003|0.016
71696586|NCT02848664|142908742|EQUIVALENCE|whether the degree of laryngeal elevation relative to hyoid elevation became greater or less after device use for 3 months||||||0.046|||||||t-test, 2 sided|||||||0.046
71696587|NCT02848664|142908743|EQUIVALENCE|pairwise comparison within subject comparing baseline with 3 months post device use|Mean Difference (Final Values)|-52.78||||0.037|TWO_SIDED|95.0|-100.751|-4.809|||ANOVA|||||-4.809|-100.751|0.037
71761198|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.1||0.0286|TWO_SIDED|95.0|-0.12|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.||-0.0|-0.12|0.0286
71761199|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.1||0.0794|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.||0.0|-0.2|0.0794
71761200|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.0||0.5906|TWO_SIDED|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.||0.1|-0.1|0.5906
71761201|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.1||0.0134|TWO_SIDED|95.0|-0.3|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.||-0.0|-0.3|0.0134
71696588|NCT00402727|142908744|NON_INFERIORITY_OR_EQUIVALENCE|The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population|Difference of cure rates (in percent)|-1.0||||||95.0|-5.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-5.3|
71696589|NCT00402727|142908745|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|1.3||||||95.0|-3.8|6.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||6.3|-3.8|
71696590|NCT00402727|142908746|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|-0.7||||||95.0|-1.6|0.6|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||0.6|-1.6|
71696591|NCT00402727|142908747|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|1.4||||||95.0|-1.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||3.9|-1.3|
71696592|NCT00402727|142908748|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|0.2||||||95.0|-3.1|2.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.4|-3.1|
71696593|NCT00402727|142908749|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|1.6||||||95.0|-2.4|5.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.3|-2.4|
71696594|NCT00402727|142908750|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.5||||||95.0|-17.0|-1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-1.4|-17.0|
71696595|NCT00402727|142908751|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.6||||||95.0|-17.6|-0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.4|-17.6|
71696596|NCT00402727|142908752|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-3.9||||||95.0|-9.5|1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||1.4|-9.5|
71696597|NCT00402727|142908753|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-5.6||||||95.0|-11.4|-0.8|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||-0.8|-11.4|
71696598|NCT00402727|142908754|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-0.1||||||95.0|-6.9|5.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||5.4|-6.9|
71696599|NCT00402727|142908755|NON_INFERIORITY_OR_EQUIVALENCE|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-2.9||||||95.0|-9.3|2.2|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.||2.2|-9.3|
71696600|NCT03188055|142908756|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||||||0.006
71696601|NCT03188055|142908757|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
71696602|NCT03188055|142908758|SUPERIORITY|||||||0.03|||||||t-test, 2 sided|||||||0.03
71696603|NCT03188055|142908759|SUPERIORITY|||||||0.063|||||||t-test, 2 sided|||||||0.063
71696604|NCT03188055|142908760|SUPERIORITY|||||||0.892|||||||t-test, 2 sided|||||||0.892
71696605|NCT03188055|142908761|SUPERIORITY||||||>|0.99||||||Using an a priori statistical significance of 0.05.|Fisher Exact|||Comparison of concordance status by intervention status (outcome by predictor).||||> . 99
71696606|NCT03188055|142908762|SUPERIORITY|||||||0.188|||||||t-test, 2 sided|||||||0.188
71696607|NCT03188055|142908763|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
71696608|NCT03188055|142908765|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
71696609|NCT03188055|142908766|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71696610|NCT00944710|142908776|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.0||||0.33|TWO_SIDED|95.0|-10.0|30.0|||Binomial regression|adjusted for visual acuity at randomization||||30|-10|0.33
71696611|NCT00944710|142908781|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.05||||0.12|TWO_SIDED|95.0|-0.01|0.12|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.|Positive values favor the Intensified Treatment group|The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.||0.12|-0.01|0.12
71696612|NCT00944710|142908789|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.55|TWO_SIDED|95.0|-0.23|0.43|||ANCOVA|||A treatment group difference in fellow-eye visual acuity change at the 12-week exam was evaluated using an ANCOVA model, adjusting for the fellow-eye visual acuity at randomization.||0.43|-0.23|0.55
71696613|NCT00944710|142908798|SUPERIORITY_OR_OTHER|||||||0.23|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.23
71696614|NCT00944710|142908799|SUPERIORITY_OR_OTHER|||||||0.66|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.||||0.66
71696615|NCT00264147|142908800|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||<0.001
71696616|NCT00264147|142908800|SUPERIORITY_OR_OTHER_LEGACY|||||||0.057||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.||||||0.057
71696617|NCT00264147|142908800|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|18.53||||||95.0|7.84|28.65|||||CI based on the Wilson's score method.|||28.65|7.84|
71696618|NCT00264147|142908800|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|10.0||||||95.0|-0.66|20.46|||||CI based on the Wilson's score method.|||20.46|-0.66|
71696619|NCT00264147|142908800|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|9.18||||||95.0|-1.25|19.39|||||CI based on the Wilson's score method.|||19.39|-1.25|
71696620|NCT00264147|142908800|SUPERIORITY_OR_OTHER_LEGACY||difference in percentage of patients|6.49||||||95.0|-3.76|16.61|||||CI based on the Wilson's score method.|||16.61|-3.76|
71696621|NCT00264147|142908801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.002
71696622|NCT00264147|142908801|SUPERIORITY_OR_OTHER_LEGACY|||||||0.221||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.221
71696623|NCT00264147|142908801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.06||||||95.0|-6.44|-1.68||||||||-1.68|-6.44|
71696624|NCT00264147|142908801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.49||||||95.0|-3.91|0.93||||||||0.93|-3.91|
71696625|NCT00264147|142908801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.74||||||95.0|-5.13|-0.35||||||||-0.35|-5.13|
71696626|NCT00264147|142908801|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.5||||||95.0|-4.88|-0.12||||||||-0.12|-4.88|
71696627|NCT00264147|142908802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.001
71696628|NCT00264147|142908802|SUPERIORITY_OR_OTHER_LEGACY|||||||0.125||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.125
71696629|NCT00264147|142908802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-2.24||||||95.0|-3.64|-0.84||||||||-0.84|-3.64|
71696630|NCT00264147|142908802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.02||||||95.0|-2.44|0.41||||||||0.41|-2.44|
71696631|NCT00264147|142908802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.22||||||95.0|-2.63|0.18||||||||0.18|-2.63|
71696632|NCT00264147|142908802|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.49||||||95.0|-1.89|0.91||||||||0.91|-1.89|
71696633|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696634|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696635|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696636|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY|||||||0.023||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.023
71696637|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.16||||||95.0|-19.38|-8.95||||||||-8.95|-19.38|
71696638|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-9.21||||||95.0|-14.52|-3.9||||||||-3.90|-14.52|
71696639|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-8.87||||||95.0|-14.11|-3.63||||||||-3.63|-14.11|
71696640|NCT00264147|142908803|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.05||||||95.0|-11.27|-0.83||||||||-0.83|-11.27|
71696641|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696642|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696643|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696644|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
71696645|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.56||||||95.0|-0.77|-0.35||||||||-0.35|-0.77|
71696646|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.13||||||||-0.13|-0.55|
71696647|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.4||||||95.0|-0.61|-0.19||||||||-0.19|-0.61|
71696648|NCT00264147|142908804|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-0.25||||||95.0|-0.46|-0.04||||||||-0.04|-0.46|
71696649|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||<0.001
71696650|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.018
71696651|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.017
71696652|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||95.0||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.||||||0.080
71696653|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-14.44||||||95.0|-19.62|-9.26||||||||-9.26|-19.62|
71696654|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.22||||||95.0|-11.52|-0.92||||||||-0.92|-11.52|
71696655|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-6.32||||||95.0|-11.53|-1.12||||||||-1.12|-11.53|
71696656|NCT00264147|142908805|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-4.63||||||95.0|-9.81|0.55||||||||0.55|-9.81|
71696657|NCT01618968|142908819|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.99|||||TWO_SIDED|90.0|121.61|134.7||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).||134.70|121.61|
71696658|NCT01618968|142908819|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|125.48|||||TWO_SIDED|90.0|119.43|131.84||||||To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).||131.84|119.43|
71696659|NCT01618968|142908819|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference ratio|101.85|||||TWO_SIDED|90.0|99.41|104.36||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)||104.36|99.41|
71696660|NCT01618968|142908820|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.65|||||TWO_SIDED|90.0|121.28|134.36||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||134.36|121.28|
71696661|NCT01618968|142908820|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|125.2|||||TWO_SIDED|90.0|119.16|131.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||131.55|119.16|
71696662|NCT01618968|142908820|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|101.82|||||TWO_SIDED|90.0|99.39|104.31||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)||104.31|99.39|
71696663|NCT01618968|142908821|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|94.83|||||TWO_SIDED|90.0|86.42|104.06||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||104.06|86.42|
71696664|NCT01618968|142908821|NON_INFERIORITY_OR_EQUIVALENCE|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|82.12|||||TWO_SIDED|90.0|76.16|88.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||88.55|76.16|
71696665|NCT01618968|142908821|NON_INFERIORITY_OR_EQUIVALENCE|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|115.63|||||TWO_SIDED|90.0|108.83|122.86||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)||122.86|108.83|
71696666|NCT00721799|142908822|OTHER||Hazard Ratio (HR)|0.47||||0.08|TWO_SIDED||||||Regression, Cox|||||||0.08
71696667|NCT00721799|142908822|OTHER||C-statistic|0.73||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
71696668|NCT00721799|142908823|OTHER||Hazard Ratio (HR)|0.42||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
71696669|NCT00721799|142908823|OTHER||C-statistic|0.75||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
71696670|NCT00721799|142908824|OTHER||Hazard Ratio (HR)|2.44|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71696671|NCT00721799|142908824|OTHER||C-statistic|0.74||||0.02|TWO_SIDED||||||Regression, Cox|||||||0.02
71696672|NCT00721799|142908825|OTHER||Hazard Ratio (HR)|1.12||||0.73|TWO_SIDED||||||Regression, Cox|||||||0.73
71696673|NCT00721799|142908825|OTHER||C-statistic|0.52||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
71696674|NCT00721799|142908826|OTHER||Hazard Ratio (HR)|1.11||||0.78|TWO_SIDED||||||Regression, Cox|||||||0.78
71696675|NCT00721799|142908826|OTHER||C-statistic|0.45||||0.66|TWO_SIDED||||||Regression, Cox|||||||0.66
71696676|NCT00721799|142908827|OTHER||Hazard Ratio (HR)|2.25||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
71696677|NCT00721799|142908827|OTHER||C-statistic|0.7||||0.05|TWO_SIDED||||||Regression, Cox|||||||0.05
71696678|NCT00721799|142908828|OTHER||Hazard Ratio (HR)|0.83||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
71696679|NCT00721799|142908828|OTHER||C-statistic|0.58||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
71696680|NCT00721799|142908829|OTHER||Hazard Ratio (HR)|0.81||||0.58|TWO_SIDED||||||Regression, Cox|||||||0.58
71696681|NCT00721799|142908829|OTHER||C-statistic|0.6||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
71696682|NCT00721799|142908830|OTHER||Hazard Ratio (HR)|0.94||||0.89|TWO_SIDED||||||Regression, Cox|||||||0.89
71696683|NCT00721799|142908830|OTHER||C-statistic|0.59||||0.42|TWO_SIDED||||||Regression, Cox|||||||0.42
71696684|NCT00721799|142908831|OTHER||Hazard Ratio (HR)|1.29||||0.43|TWO_SIDED||||||Regression, Cox|||||||0.43
71696685|NCT00721799|142908831|OTHER||C-statistic|0.47||||0.8|TWO_SIDED||||||Regression, Cox|||||||0.80
71696686|NCT00721799|142908832|OTHER||Hazard Ratio (HR)|2.01||||0.01|TWO_SIDED||||||Regression, Cox|||||||0.01
71696687|NCT00721799|142908832|OTHER||C-statistic|0.69||||0.07|TWO_SIDED||||||Regression, Cox|||||||0.07
71696688|NCT00721799|142908833|OTHER||Hazard Ratio (HR)|1.58||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
71696689|NCT00721799|142908833|OTHER||C-statistic|0.63||||0.25|TWO_SIDED||||||Regression, Cox|||||||0.25
71696690|NCT00721799|142908834|OTHER||Hazard Ratio (HR)|1.49||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
71696691|NCT00721799|142908834|OTHER||C-statistic|0.62||||0.27|TWO_SIDED||||||Regression, Cox|||||||0.27
71696692|NCT00721799|142908835|OTHER||Hazard Ratio (HR)|1.0||||0.99|TWO_SIDED||||||Regression, Cox|||||||0.99
71696693|NCT00721799|142908835|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
71696694|NCT00721799|142908836|OTHER||Hazard Ratio (HR)|1.3||||0.41|TWO_SIDED||||||Regression, Cox|||||||0.41
71696695|NCT00721799|142908836|OTHER||C-statistic|0.54||||0.69|TWO_SIDED||||||Regression, Cox|||||||0.69
71696696|NCT00721799|142908837|OTHER||Hazard Ratio (HR)|1.56||||0.17|TWO_SIDED||||||Regression, Cox|||||||0.17
71696697|NCT00721799|142908837|OTHER||C-statistic|0.64||||0.18|TWO_SIDED||||||Regression, Cox|||||||0.18
71696698|NCT00721799|142908838|OTHER||Hazard Ratio (HR)|0.42||||0.09|TWO_SIDED||||||Regression, Cox|||||||0.09
71696699|NCT00721799|142908838|OTHER||Hazard Ratio (HR)|0.72||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
71696700|NCT00721799|142908839|OTHER||Hazard Ratio (HR)|0.36||||0.06|TWO_SIDED||||||Regression, Cox|||||||0.06
71696701|NCT00721799|142908839|OTHER||C-statistic|0.74||||0.04|TWO_SIDED||||||Regression, Cox|||||||0.04
71696702|NCT00721799|142908840|OTHER||Hazard Ratio (HR)|3.01|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71696703|NCT00721799|142908840|OTHER||C-statistic|0.82|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71696704|NCT00721799|142908841|OTHER||Hazard Ratio (HR)|1.03||||0.92|TWO_SIDED||||||Regression, Cox|||||||0.92
71696705|NCT00721799|142908841|OTHER||C-statistic|0.48||||0.84|TWO_SIDED||||||Regression, Cox|||||||0.84
71696706|NCT00721799|142908842|OTHER||Hazard Ratio (HR)|1.11||||0.76|TWO_SIDED||||||Regression, Cox|||||||0.76
71696707|NCT00721799|142908842|OTHER||C-statistic|0.45||||0.68|TWO_SIDED||||||Regression, Cox|||||||0.68
71696708|NCT00721799|142908843|OTHER||Hazard Ratio (HR)|2.99|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71696709|NCT00721799|142908843|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
71696710|NCT00721799|142908844|OTHER||Hazard Ratio (HR)|0.78||||0.55|TWO_SIDED||||||Regression, Cox|||||||0.55
71696711|NCT00721799|142908844|OTHER||C-statistic|0.61||||0.35|TWO_SIDED||||||Regression, Cox|||||||0.35
71696712|NCT00721799|142908845|OTHER||Hazard Ratio (HR)|0.74||||0.48|TWO_SIDED||||||Regression, Cox|||||||0.48
71696713|NCT00721799|142908845|OTHER||C-statistic|0.63||||0.28|TWO_SIDED||||||Regression, Cox|||||||0.28
71696714|NCT00721799|142908846|OTHER||Hazard Ratio (HR)|0.81||||0.67|TWO_SIDED||||||Regression, Cox|||||||0.67
71696715|NCT00721799|142908846|OTHER||C-statistic|0.71||||0.11|TWO_SIDED||||||Regression, Cox|||||||0.11
71696716|NCT00721799|142908847|OTHER||Hazard Ratio (HR)|1.32||||0.4|TWO_SIDED||||||Regression, Cox|||||||0.40
71696717|NCT00721799|142908847|OTHER||C-statistic|0.48||||0.88|TWO_SIDED||||||Regression, Cox|||||||0.88
71696718|NCT00721799|142908848|OTHER||Hazard Ratio (HR)|2.39|||<|0.01|TWO_SIDED||||||Regression, Cox|||||||<0.01
71696719|NCT00721799|142908848|OTHER||C-statistic|0.74||||0.03|TWO_SIDED||||||Regression, Cox|||||||0.03
71696720|NCT00721799|142908849|OTHER||Hazard Ratio (HR)|1.51||||0.26|TWO_SIDED||||||Regression, Cox|||||||0.26
71696721|NCT00721799|142908849|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
71696722|NCT00721799|142908850|OTHER||Hazard Ratio (HR)|1.38||||0.37|TWO_SIDED||||||Regression, Cox|||||||0.37
71696723|NCT00721799|142908850|OTHER||C-statistic|0.59||||0.46|TWO_SIDED||||||Regression, Cox|||||||0.46
71696724|NCT00721799|142908851|OTHER||Hazard Ratio (HR)|1.05||||0.9|TWO_SIDED||||||Regression, Cox|||||||0.90
71696725|NCT00721799|142908851|OTHER||C-statistic|0.52||||0.87|TWO_SIDED||||||Regression, Cox|||||||0.87
71696726|NCT00721799|142908852|OTHER||Hazard Ratio (HR)|1.35||||0.36|TWO_SIDED||||||Regression, Cox|||||||0.36
71696727|NCT00721799|142908852|OTHER||C-statistic|0.56||||0.63|TWO_SIDED||||||Regression, Cox|||||||0.63
71696728|NCT00721799|142908853|OTHER||Hazard Ratio (HR)|1.56||||0.2|TWO_SIDED||||||Regression, Cox|||||||0.20
71696729|NCT00721799|142908853|OTHER||C-statistic|0.63||||0.24|TWO_SIDED||||||Regression, Cox|||||||0.24
71696730|NCT04356937|142908885|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.64|TWO_SIDED|95.0|0.38|1.81|||Log Rank|||||1.81|0.38|0.64
71696731|NCT04356937|142908886|SUPERIORITY||Hazard Ratio (HR)|1.11||||0.73|TWO_SIDED|95.0|0.59|2.1|||Log Rank|||||2.10|0.59|0.73
71696732|NCT04356937|142908887|SUPERIORITY||Hazard Ratio (HR)|0.94||||0.69|TWO_SIDED|95.0|0.67|1.3|||Log Rank|||||1.30|0.67|0.69
71696733|NCT03141359|142908894|SUPERIORITY||Rate|0.627||||0.388|TWO_SIDED|95.0|0.492|0.75|||Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|We used a single-stage design to test null hypothesis (H0) that 1-yr PFS is \<= 0.60. Assuming one-sided α= 0.10, 60 patients provided 98% power to reject H0, assuming the true 1-yr PFS is 0.80. Since not all enrolled subjects received durva, study power was affected. For patients who did not receive durva, H0 was assumed to be 0.40 versus an alternative of 0.60. Including these subjects reduced power from 98%. The conditional power given that 13 evaluable subjects didn't receive durva was 88%.||0.750|0.492|.388
71696734|NCT03141359|142908897|OTHER|Estimation only|Rate|0.571|||||TWO_SIDED|95.0|0.422|0.712|||||Confidence interval estimated using the Clopper Pearson method.|||0.712|0.422|
71696735|NCT03141359|142908898|OTHER|Estimation only|Rate|0.75|||||TWO_SIDED|95.0|0.621|0.853|||||Confidence interval estimated using the Clopper Pearson method.|||0.853|0.621|
71696736|NCT03141359|142908906|OTHER|Estimation only|Rate|0.164|||||TWO_SIDED|95.0|0.082|0.281|||||Confidence interval estimated using the Clopper Pearson method.|||0.281|0.082|
71696737|NCT03141359|142908907|OTHER|Estimation only|Rate|0.246|||||TWO_SIDED|95.0|0.145|0.373|||||Confidence interval estimated using the Clopper Pearson method.|||0.373|0.145|
71696738|NCT01081626|142908913|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0135||||0.956|TWO_SIDED|95.0|-0.1325|0.1637|||Chi-squared, Corrected|||||0.1637|-0.1325|0.9560
71696739|NCT01081626|142908914|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.088||||0.7924|TWO_SIDED|95.0|0.7642|1.549|||Chi-squared|||||1.5490|0.7642|0.7924
71696740|NCT01081626|142908918|SUPERIORITY_OR_OTHER|||||||0.5331||95.0|||||Chi-squared|||||||0.5331
71696741|NCT01081626|142908919|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.015||||0.9351|TWO_SIDED|95.0|0.7175|1.435|||Chi-squared|||||1.4350|0.7175|0.9351
71696742|NCT00720278|142908945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.06|STANDARD_DEVIATION|0.47|<|0.001||95.0|-2.98|-1.14|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.14|-2.98|<0.001
71696743|NCT00720278|142908945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.0|STANDARD_DEVIATION|0.465|<|0.001||95.0|-3.91|-2.09|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-2.09|-3.91|<0.001
71696744|NCT00720278|142908946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78|STANDARD_DEVIATION|0.479|<|0.001||95.0|-2.72|-0.84|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.84|-2.72|<0.001
71696745|NCT00720278|142908946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.668|STANDARD_DEVIATION|0.4735|<|0.001||95.0|-3.6|-1.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.74|-3.60|<0.001
71696746|NCT00720278|142908947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.376|STANDARD_DEVIATION|0.418||0.001||95.0|-2.2|-0.56|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-0.56|-2.20|0.001
71696747|NCT00720278|142908947|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.432|STANDARD_DEVIATION|0.4145|<|0.001||95.0|-3.24|-1.62|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14||-1.62|-3.24|<0.001
71696748|NCT03312738|142908952|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|90.0|0.4|0.71||||||||0.71|0.40|
71696749|NCT03312738|142908953|OTHER||Hazard Ratio (HR)|0.46|||||TWO_SIDED|90.0|0.32|0.67||||||||0.67|0.32|
71696750|NCT03312738|142908954|OTHER||Hazard Ratio (HR)|1.14|||||TWO_SIDED|90.0|0.69|1.89||||||||1.89|0.69|
71696751|NCT02014272|142909009|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.45|||||TWO_SIDED|90.0|92.07|98.94||||||Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||98.94|92.07|
71696752|NCT02014272|142909009|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|103.45|||||TWO_SIDED|90.0|99.33|107.75||||||Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||107.75|99.33|
71696753|NCT02014272|142909010|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|91.63|||||TWO_SIDED|90.0|83.13|101.01||||||Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||101.01|83.13|
71696754|NCT02014272|142909010|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|107.58|||||TWO_SIDED|90.0|96.07|120.47||||||Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||120.47|96.07|
71696755|NCT02014272|142909011|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|95.92|||||TWO_SIDED|90.0|92.54|99.43||||||Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||99.43|92.54|
71696756|NCT02014272|142909011|SUPERIORITY_OR_OTHER||Ratio of adjusted geometric means|102.41|||||TWO_SIDED|90.0|98.76|106.19||||||Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.||106.19|98.76|
71696757|NCT01248455|142909046|SUPERIORITY_OR_OTHER_LEGACY|||||||0.56|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).||||0.56
71696758|NCT01450813|142909054|NON_INFERIORITY_OR_EQUIVALENCE|Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.|||||<|0.05||||||Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.|ANOVA|||Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.||||< 0.05
71696759|NCT03073486|142909056|OTHER|||||||0.2301|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.2301
71696760|NCT03073486|142909057|OTHER|||||||0.6888|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation||||||0.6888
71696761|NCT03073486|142909058|OTHER|||||||0.1361|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation||||||0.1361
71696762|NCT01178294|142909074|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED||||||one-sided binomial exact test|||Summary statistics for the percentage of participants with serious bleeding episodes responsive at 24 hours after the initiation of treatment are presented, along with the 95% confidence interval (two-sided 95% Clopper-Pearson confidence interval).||||<0.001
71696763|NCT03435055|142909092|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that the results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.001
71696764|NCT03435055|142909093|SUPERIORITY|||||||0.006|||||||t-test, 2 sided|||Paired t-test were conducted on subject specific beta maps to identify changes in connectivity associated with nitrous oxide in SPM12. Hypothesis was that results would be deemed significant at false discovery rate (FDR) cluster level corrected p \< 0.05 derived from a voxel-wise uncorrected p-value \< 0.001.||||0.006
71696765|NCT03435055|142909094|SUPERIORITY||||||<|0.01|||||||t-test, 2 sided|||Paired-t tests were conducted to determine whether changes in stimulus intensity: post stimulus at baseline and under subanesthetic dose of nitrous oxide. Statistical tests were completed in SPSS 26 and determined by p \< 0.05.||||<0.01
71696766|NCT03435055|142909095|OTHER|Paired T-test comparing baseline to nitrous||||||0.0622|||||||Paired t-test|||Delta||||0.0622
71696767|NCT03435055|142909095|OTHER|Paired T-test comparing baseline to nitrous||||||0.0292|||||||Paired t-test|||Theta||||0.0292
71696768|NCT03435055|142909095|OTHER|Paired T-test comparing baseline to nitrous||||||0.5905|||||||Paired t-test|||Alpha comparison||||0.5905
71696769|NCT02089347|142909096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|1.42|||||TWO_SIDED|95.0|-0.31|4.61||||||Non-inferiority comparison of post-booster response for Diphtheria.||4.61|-0.31|
71696770|NCT02089347|142909096|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by the data if lower bound ot the two-sided 95% is greater than -10%|Wilson score method|6.25|||||TWO_SIDED|95.0|3.32|10.84||||||Non-inferiority comparison of post-vaccination booster response for tetanus||10.84|3.32|
71696771|NCT02089347|142909097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|0.57|||||TWO_SIDED|95.0|-0.61|3.15||||||Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL||3.15|-0.61|
71696772|NCT02089347|142909097|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%.|Wilson score method|0.0|||||TWO_SIDED|95.0|-1.09|2.14||||||Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL||2.14|-1.09|
71696773|NCT03176771|142909134|SUPERIORITY||Mean Difference (Final Values)|-3.6|STANDARD_ERROR_OF_MEAN|0.5|<|0.001|TWO_SIDED|95.0|-4.5|-2.6|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~* AIMS dyskinesia total score mean change from baseline (CFB): MT-5199 80 mg vs. placebo.~* AIMS: MT-5199 40 mg vs. PBO. For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."||-2.6|-4.5|<0.001
71696774|NCT03176771|142909134|SUPERIORITY||Median Difference (Final Values)|-2.2|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.0|-1.3|||Mixed-effect Model Repeated Measures|||||-1.3|-3.0|<0.001
71696775|NCT03176771|142909135|SUPERIORITY||Risk Difference (RD)|13.6||||0.027|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.027
71696776|NCT03176771|142909135|SUPERIORITY||Risk Difference (RD)|36.9|||<|0.001|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||<0.001
71696777|NCT03176771|142909136|SUPERIORITY||Mean Difference (Final Values)|-1.5|STANDARD_ERROR_OF_MEAN|0.6||0.013|TWO_SIDED|95.0|-2.7|-0.3|||Mixed-effect Model Repeated Measures|||||-0.3|-2.7|0.013
71696778|NCT03176771|142909136|SUPERIORITY||Mean Difference (Final Values)|-2.3|STANDARD_ERROR_OF_MEAN|0.6|<|0.001|TWO_SIDED|95.0|-3.5|-1.1|||Mixed-effect Model Repeated Measures|||||-1.1|-3.5|<0.001
71696779|NCT03176771|142909137|SUPERIORITY||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.021|TWO_SIDED|95.0|-0.7|-0.1|||ANOVA|||||-0.1|-0.7|0.021
71696780|NCT03176771|142909137|SUPERIORITY||Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED|95.0|-1.0|-0.3|||ANOVA|||||-0.3|-1.0|<0.001
71696781|NCT02662569|142909153|SUPERIORITY||LS Mean Treatment Difference|-70.29|STANDARD_ERROR_OF_MEAN|2.61|<|0.0001|TWO_SIDED|95.0|-75.43|-65.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.16|-75.43|<0.0001
71696782|NCT02662569|142909153|SUPERIORITY||LS Mean Treatment Difference|-70.04|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-74.67|-65.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-65.41|-74.67|<0.0001
71696783|NCT02662569|142909154|SUPERIORITY||LS Mean Treatment Difference|-71.77|STANDARD_ERROR_OF_MEAN|2.97|<|0.0001|TWO_SIDED|95.0|-77.61|-65.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-65.93|-77.61|<0.0001
71696784|NCT02662569|142909154|SUPERIORITY||LS Mean Treatment Difference|-64.93|STANDARD_ERROR_OF_MEAN|2.56|<|0.0001|TWO_SIDED|95.0|-69.97|-59.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-59.89|-69.97|<0.0001
71696785|NCT02662569|142909155|SUPERIORITY||LS Mean Treatment Difference|-62.5|STANDARD_ERROR_OF_MEAN|2.9|<|0.0001|TWO_SIDED|95.0|-68.2|-56.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.9|-68.2|<0.0001
71696786|NCT02662569|142909155|SUPERIORITY||LS Mean Treatment Difference|-63.1|STANDARD_ERROR_OF_MEAN|2.7|<|0.0001|TWO_SIDED|95.0|-68.4|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-57.8|-68.4|<0.0001
71696787|NCT02662569|142909156|SUPERIORITY||LS Mean Treatment Difference|-63.6|STANDARD_ERROR_OF_MEAN|3.1|<|0.0001|TWO_SIDED|95.0|-69.7|-57.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-57.6|-69.7|<0.0001
71696788|NCT02662569|142909156|SUPERIORITY||LS Mean Treatment Difference|-58.8|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001|TWO_SIDED|95.0|-64.3|-53.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-53.3|-64.3|<0.0001
71696789|NCT02662569|142909157|SUPERIORITY||LS Mean Treatment Difference|-60.9|STANDARD_ERROR_OF_MEAN|2.35|<|0.0001|TWO_SIDED|95.0|-65.51|-56.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.29|-65.51|<0.0001
71696790|NCT02662569|142909157|SUPERIORITY||LS Mean Treatment Difference|-59.4|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-63.52|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-55.29|-63.52|<0.0001
71696791|NCT02662569|142909158|SUPERIORITY||LS Mean Treatment Difference|-61.64|STANDARD_ERROR_OF_MEAN|2.64|<|0.0001|TWO_SIDED|95.0|-66.82|-56.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-56.45|-66.82|<0.0001
71696792|NCT02662569|142909158|SUPERIORITY||LS Mean Treatment Difference|-54.22|STANDARD_ERROR_OF_MEAN|2.28|<|0.0001|TWO_SIDED|95.0|-58.7|-49.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-49.74|-58.70|<0.0001
71696793|NCT02662569|142909159|SUPERIORITY||LS Mean Treatment Difference|-56.93|STANDARD_ERROR_OF_MEAN|2.03|<|0.0001|TWO_SIDED|95.0|-60.93|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.93|-60.93|<0.0001
71696794|NCT02662569|142909159|SUPERIORITY||LS Mean Treatment Difference|-54.85|STANDARD_ERROR_OF_MEAN|1.87|<|0.0001|TWO_SIDED|95.0|-58.52|-51.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-51.18|-58.52|<0.0001
71696795|NCT02662569|142909160|SUPERIORITY||LS Mean Treatment Difference|-57.06|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001|TWO_SIDED|95.0|-61.59|-52.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-52.54|-61.59|<0.0001
71696796|NCT02662569|142909160|SUPERIORITY||LS Mean Treatment Difference|-49.42|STANDARD_ERROR_OF_MEAN|1.98|<|0.0001|TWO_SIDED|95.0|-53.31|-45.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-45.53|-53.31|<0.0001
71696797|NCT02662569|142909161|SUPERIORITY||LS Mean Treatment Difference|-41.53|STANDARD_ERROR_OF_MEAN|1.74|<|0.0001|TWO_SIDED|95.0|-44.95|-38.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.10|-44.95|<0.0001
71696798|NCT02662569|142909161|SUPERIORITY||LS Mean Treatment Difference|-39.5|STANDARD_ERROR_OF_MEAN|1.51|<|0.0001|TWO_SIDED|95.0|-42.47|-36.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-36.53|-42.47|<0.0001
71696799|NCT02662569|142909162|SUPERIORITY||LS Mean Treatment Difference|-42.22|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-46.02|-38.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-38.42|-46.02|<0.0001
71761202|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.1||0.1759|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.||0.0|-0.2|0.1759
71696800|NCT02662569|142909162|SUPERIORITY||LS Mean Treatment Difference|-35.89|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-39.12|-32.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-32.67|-39.12|<0.0001
71696801|NCT02662569|142909163|SUPERIORITY||LS Mean Treatment Difference|-44.09|STANDARD_ERROR_OF_MEAN|1.81|<|0.0001|TWO_SIDED|95.0|-47.64|-40.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-40.54|-47.64|<0.0001
71696802|NCT02662569|142909163|SUPERIORITY||LS Mean Treatment Difference|-43.67|STANDARD_ERROR_OF_MEAN|1.64|<|0.0001|TWO_SIDED|95.0|-46.9|-40.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-40.44|-46.90|<0.0001
71696803|NCT02662569|142909164|SUPERIORITY||LS Mean Treatment Difference|-43.94|STANDARD_ERROR_OF_MEAN|2.02|<|0.0001|TWO_SIDED|95.0|-47.9|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-39.97|-47.90|<0.0001
71696804|NCT02662569|142909164|SUPERIORITY||LS Mean Treatment Difference|-40.56|STANDARD_ERROR_OF_MEAN|1.79|<|0.0001|TWO_SIDED|95.0|-44.08|-37.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.04|-44.08|<0.0001
71696805|NCT02662569|142909165|SUPERIORITY||LS Mean Treatment Difference|-58.2|STANDARD_ERROR_OF_MEAN|2.01|<|0.0001|TWO_SIDED|95.0|-62.15|-54.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-54.25|-62.15|<0.0001
71696806|NCT02662569|142909165|SUPERIORITY||LS Mean Treatment Difference|-56.73|STANDARD_ERROR_OF_MEAN|1.93|<|0.0001|TWO_SIDED|95.0|-60.53|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-52.93|-60.53|<0.0001
71696807|NCT02662569|142909166|SUPERIORITY||LS Mean Treatment Difference|-58.21|STANDARD_ERROR_OF_MEAN|2.23|<|0.0001|TWO_SIDED|95.0|-62.59|-53.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-53.84|-62.59|<0.0001
71696808|NCT02662569|142909166|SUPERIORITY||LS Mean Treatment Difference|-51.7|STANDARD_ERROR_OF_MEAN|2.09|<|0.0001|TWO_SIDED|95.0|-55.81|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-47.59|-55.81|<0.0001
71696809|NCT02662569|142909167|SUPERIORITY||Treatment Difference|68.4|||<|0.0001|TWO_SIDED|95.0|60.4|74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||74.8|60.4|<0.0001
71696810|NCT02662569|142909167|SUPERIORITY||Treatment Difference|71.9|||<|0.0001|TWO_SIDED|95.0|64.1|77.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||77.9|64.1|<0.0001
71696811|NCT02662569|142909168|SUPERIORITY||Treatment Difference|67.2|||<|0.0001|TWO_SIDED|95.0|58.9|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W|||73.9|58.9|<0.0001
71696812|NCT02662569|142909168|SUPERIORITY||Treatment Difference|68.8|||<|0.0001|TWO_SIDED|95.0|60.6|75.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM|||75.3|60.6|<0.0001
71696813|NCT02662569|142909169|SUPERIORITY||LS Mean Treatment Difference|-55.52|STANDARD_ERROR_OF_MEAN|18.85|<|0.0001|TWO_SIDED|95.0|-92.64|-18.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-18.40|-92.64|<0.0001
71696814|NCT02662569|142909169|SUPERIORITY||LS Mean Treatment Difference|-50.77|STANDARD_ERROR_OF_MEAN|6.63|<|0.0001|TWO_SIDED|95.0|-63.82|-37.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-37.72|-63.82|<0.0001
71696815|NCT02662569|142909170|SUPERIORITY||LS Mean Treatment Difference|-62.46|STANDARD_ERROR_OF_MEAN|24.64|<|0.0001|TWO_SIDED|95.0|-110.89|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-14.03|-110.89|<0.0001
71696816|NCT02662569|142909170|SUPERIORITY||LS Mean Treatment Difference|-45.32|STANDARD_ERROR_OF_MEAN|8.42|<|0.0001|TWO_SIDED|95.0|-61.87|-28.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-28.77|-61.87|<0.0001
71696817|NCT02662569|142909171|SUPERIORITY||LS Mean Treatment Difference|-18.02|STANDARD_ERROR_OF_MEAN|4.01||0.0002|TWO_SIDED|95.0|-25.89|-10.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-10.14|-25.89|0.0002
71696818|NCT02662569|142909171|SUPERIORITY||LS Mean Treatment Difference|-15.63|STANDARD_ERROR_OF_MEAN|3.08|<|0.0001|TWO_SIDED|95.0|-21.69|-9.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-9.58|-21.69|<0.0001
71696819|NCT02662569|142909172|SUPERIORITY||LS Mean Treatment Difference|-16.41|STANDARD_ERROR_OF_MEAN|14.18||0.0002|TWO_SIDED|95.0|-24.63|-8.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-8.19|-24.63|0.0002
71696820|NCT02662569|142909172|SUPERIORITY||LS Mean Treatment Difference|-12.31|STANDARD_ERROR_OF_MEAN|3.28|<|0.0001|TWO_SIDED|95.0|-18.76|-5.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-5.86|-18.76|<0.0001
71696821|NCT02662569|142909173|SUPERIORITY||LS Mean Treatment Difference|6.34|STANDARD_ERROR_OF_MEAN|1.52||0.0003|TWO_SIDED|95.0|3.36|9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.33|3.36|0.0003
71696822|NCT02662569|142909173|SUPERIORITY||LS Mean Treatment Difference|7.87|STANDARD_ERROR_OF_MEAN|1.41|<|0.0001|TWO_SIDED|95.0|5.1|10.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||10.65|5.10|<0.0001
71696823|NCT02662569|142909174|SUPERIORITY||LS Mean Treatment Difference|5.88|STANDARD_ERROR_OF_MEAN|1.72||0.0003|TWO_SIDED|95.0|2.49|9.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||9.27|2.49|0.0003
71696824|NCT02662569|142909174|SUPERIORITY||LS Mean Treatment Difference|8.14|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|5.03|11.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||11.25|5.03|<0.0001
71696825|NCT02662569|142909175|SUPERIORITY||LS Mean Treatment Difference|-27.18|STANDARD_ERROR_OF_MEAN|3.57|<|0.0001|TWO_SIDED|95.0|-34.2|-20.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W|||-20.17|-34.20|<0.0001
71696826|NCT02662569|142909175|SUPERIORITY||LS Mean Treatment Difference|-24.01|STANDARD_ERROR_OF_MEAN|2.99|<|0.0001|TWO_SIDED|95.0|-29.88|-18.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM|||-18.14|-29.88|<0.0001
71696827|NCT00289211|142909176|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.048||||0.048||95.0|1.008|4.164|||Regression, Cox|||Subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations. Entries of 4.0 (hours) for median time to event or 95% CI indicate that data were NE (see Population Description). As non-numeric data are not supported by the median and 95% CI fields, entry of the actual results (ie, NE or \>4.0) was not possible.||4.164|1.008|0.048
71696828|NCT00289211|142909177|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.41||||0.062||95.0|0.87|2.29|||Cochran-Mantel-Haenszel|||||2.29|0.87|0.062
71696829|NCT00289211|142909178|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|2.717||||0.001||95.0|1.471|5.02|||Regression, Cox|||Subjects who had not experienced complete resolution of the HAE attack at the time of the follow-up telephone call, or who were lost to follow-up, were censored at 72 hours.||5.020|1.471|0.001
71696830|NCT00289211|142909179|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71696831|NCT00289211|142909179|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71696832|NCT00289211|142909179|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71696833|NCT00289211|142909179|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0007
71696834|NCT00289211|142909180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71696835|NCT00289211|142909180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71696836|NCT00289211|142909180|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||95.0||||Percent change 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||<0.0001
71696837|NCT00289211|142909180|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0022||95.0||||Percent change 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0022
71696838|NCT00289211|142909181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.1321||95.0||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1321
71696839|NCT00289211|142909181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.5218||95.0||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.5218
71696840|NCT00289211|142909181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.121||95.0||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.1210
71696841|NCT00289211|142909181|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0017||95.0||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)|||||||0.0017
71696842|NCT01924533|142909308|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.79||||0.0262|TWO_SIDED|97.5|0.63|1.0|||Cox proportional hazards model|||||1.00|0.63|0.0262
71696843|NCT01924533|142909309|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.73||||0.2458|TWO_SIDED|97.5|0.4|1.34|||Cox proportional hazards model|||||1.34|0.40|0.2458
71696844|NCT01924533|142909310|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.84||||0.0645|TWO_SIDED|97.5|0.67|1.04|||Cox proportional hazards model|||||1.04|0.67|0.0645
71696845|NCT01924533|142909311|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.74||||0.2199|TWO_SIDED|97.5|0.42|1.29|||Cox proportional hazards model|||||1.29|0.42|0.2199
71696846|NCT01924533|142909312|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.69||||0.0548|TWO_SIDED|97.5|0.92|3.17|||Regression, Logistic|||||3.17|0.92|0.0548
71696847|NCT01924533|142909313|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|4.24||||0.0309|TWO_SIDED|97.5|0.95|23.23|||Regression, Logistic|||||23.23|0.95|0.0309
71696848|NCT01924533|142909314|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.82||||0.0716|TWO_SIDED|97.5|0.64|1.05|||Cox proportional hazards model|||||1.05|0.64|0.0716
71696849|NCT01924533|142909315|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.63||||0.0927|TWO_SIDED|97.5|0.34|1.16|||Cox proportional hazards model|||||1.16|0.34|0.0927
71696850|NCT02747927|142909320|OTHER||Vaccine Efficacy (VE)|80.2|||<|0.001|TWO_SIDED|95.0|73.3|85.3||Statistical significance was concluded if the lower bound of the 95% CI for the VE was above 25%. Since the hypotheses was tested in a confirmatory manner at a 2-sided significance level of 5%, the calculated p-value was compared with 0.025.|Cox Proportional Hazard Model|VE and 95% CIs was estimated from Cox proportional hazard model with investigational product as a factor, adjusted for age, and stratified by region.||Assuming true VE of 60% and, virologically confirmed cases of dengue fever induced by any dengue serotype occurring from 30 days post 2nd vaccination (Day 120) until end of Part 1 would provide at least 90% power to rule out vaccine effect of ≤25%.||85.3|73.3|<0.001
71696851|NCT05412134|142909336|OTHER|||||||0.333|||||||Chi-squared|||Repetition adherence||||0.333
71696852|NCT05412134|142909336|OTHER|||||||0.626|||||||Chi-squared|||Session adherence||||0.626
71696853|NCT05412134|142909337|SUPERIORITY|||||||0.416|||||||Wilcoxon (Mann-Whitney)|||||||0.416
71696854|NCT05412134|142909338|SUPERIORITY|||||||0.581|||||||t-test, 2 sided|||||||0.581
71696855|NCT05412134|142909339|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||||||0.071
71696856|NCT05412134|142909340|SUPERIORITY|||||||0.356|||||||t-test, 2 sided|||||||0.356
71696857|NCT05412134|142909342|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
71696858|NCT04275336|142909345|OTHER||H value|1.344||||0.511|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.511
71696859|NCT04275336|142909346|OTHER||H value|5.272||||0.072|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.072
71696860|NCT04275336|142909347|OTHER||H value|0.198||||0.906|ONE_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.906
71696861|NCT04275336|142909348|OTHER||H value|6.679||||0.035|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.035
71696862|NCT04275336|142909349|OTHER||Mean Difference (Final Values)|0.17||||0.844|TWO_SIDED|95.0||||\<0.05|ANOVA|||||||0.844
71696863|NCT04275336|142909350|OTHER||H value|1.651||||0.438|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.438
71696864|NCT04275336|142909351|OTHER||H value|0.341||||0.843|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.843
71696865|NCT04275336|142909352|OTHER||Median Difference (Final Values)|1.642||||0.44|TWO_SIDED|95.0||||\<0.05|Kruskal-Wallis|||||||0.440
71696866|NCT04664205|142909353|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71696867|NCT04664205|142909354|SUPERIORITY|||||||0.069|||||||ANCOVA|||||||0.069
71696868|NCT04664205|142909355|SUPERIORITY|||||||0.478|||||||ANOVA|||||||0.478
71696869|NCT01578772|142909361|SUPERIORITY_OR_OTHER||Median Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.1|0.1|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||0.1|-0.1|<0.05
71696870|NCT01578772|142909362|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.7|||<|0.05|TWO_SIDED|95.0|-1.3|1.9|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.||||1.9|-1.3|<0.05
71696871|NCT00808340|142909426|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5.|Mean Difference (Final Values)|-0.1249|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.4143|0.1644|||Mixed Models Analysis||Mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1644|-0.4143|
71696872|NCT00808340|142909426|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3693|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.6587|-0.07996|||Mixed Models Analysis||The mean difference was calculated as balafilcon A multifocal minus senofilcon A multifocal prod.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.07996|-0.6587|
71696873|NCT00808340|142909427|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.04083|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.2485|0.3302|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.3302|-0.2485|
71696874|NCT00808340|142909427|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.4608|STANDARD_ERROR_OF_MEAN|0.1464|||TWO_SIDED|97.5|-0.7502|-0.1714|||Mixed Models Analysis||The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.1714|-0.7502|
71696875|NCT00808340|142909428|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.02941|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.08153|0.02271|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.02271|-0.08153|
71696876|NCT00808340|142909428|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.06765|STANDARD_ERROR_OF_MEAN|0.02656|||TWO_SIDED|97.5|-0.1198|-0.01553|||Mixed Models Analysis||The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||-0.01553|-0.1198|
71696877|NCT00808340|142909429|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3304|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.779|0.1183|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.||0.1183|-0.779|
71696878|NCT00808340|142909429|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.2281|STANDARD_ERROR_OF_MEAN|0.2243|||TWO_SIDED|97.5|-0.6767|0.2206|||Mixed Models Analysis||The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.||0.2206|-0.6767|
71696879|NCT02175121|142909439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-40.33|STANDARD_ERROR_OF_MEAN|6.75|<|0.0001|TWO_SIDED|90.0|-51.49|-29.16||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-29.16|-51.49|<0.0001
71696880|NCT02175121|142909439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-45.53|STANDARD_ERROR_OF_MEAN|6.98|<|0.0001|TWO_SIDED|90.0|-57.08|-33.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-33.99|-57.08|<0.0001
71696881|NCT02175121|142909439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.79|STANDARD_ERROR_OF_MEAN|6.73|<|0.0001|TWO_SIDED|90.0|-79.92|-57.65||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-57.65|-79.92|<0.0001
71696882|NCT02175121|142909439|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-68.12|STANDARD_ERROR_OF_MEAN|6.86|<|0.0001|TWO_SIDED|90.0|-79.46|-56.78||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.||-56.78|-79.46|<0.0001
71696883|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-16.25|STANDARD_ERROR_OF_MEAN|5.83||0.006|TWO_SIDED|90.0|-25.9|-6.6||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-6.60|-25.90|0.0060
71696884|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-26.98|STANDARD_ERROR_OF_MEAN|5.94|<|0.0001|TWO_SIDED|90.0|-36.81|-17.15||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-17.15|-36.81|<0.0001
71696885|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-39.6|STANDARD_ERROR_OF_MEAN|5.8|<|0.0001|TWO_SIDED|90.0|-49.2|-30.0||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-30.00|-49.20|<0.0001
71696886|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-46.72|STANDARD_ERROR_OF_MEAN|5.89|<|0.0001|TWO_SIDED|90.0|-56.46|-36.98||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||-36.98|-56.46|<0.0001
71696887|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-27.07|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-35.89|-18.25||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-18.25|-35.89|<0.0001
71696888|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-36.18|STANDARD_ERROR_OF_MEAN|5.46|<|0.0001|TWO_SIDED|90.0|-45.21|-27.14||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-27.14|-45.21|<0.0001
71696889|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-51.47|STANDARD_ERROR_OF_MEAN|5.33|<|0.0001|TWO_SIDED|90.0|-60.29|-42.65||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-42.65|-60.29|<0.0001
71696890|NCT02175121|142909440|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-57.17|STANDARD_ERROR_OF_MEAN|5.41|<|0.0001|TWO_SIDED|90.0|-66.12|-48.22||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||-48.22|-66.12|<0.0001
71696891|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.86|STANDARD_ERROR_OF_MEAN|10.13||0.2063|TWO_SIDED|90.0|-3.91|29.62||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||29.62|-3.91|0.2063
71696892|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.03|STANDARD_ERROR_OF_MEAN|10.33||0.2087|TWO_SIDED|90.0|-4.05|30.11||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||30.11|-4.05|0.2087
71696893|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|5.6|STANDARD_ERROR_OF_MEAN|10.1||0.5802|TWO_SIDED|90.0|-11.11|22.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||22.30|-11.11|0.5802
71696894|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.64|STANDARD_ERROR_OF_MEAN|10.25||0.1553|TWO_SIDED|90.0|-2.32|31.59||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||31.59|-2.32|0.1553
71696895|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2|STANDARD_ERROR_OF_MEAN|7.66||0.7741|TWO_SIDED|90.0|-14.87|10.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.47|-14.87|0.7741
71696896|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|7.78||0.9588|TWO_SIDED|90.0|-13.28|12.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||12.47|-13.28|0.9588
71696897|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.42|STANDARD_ERROR_OF_MEAN|7.61||0.8523|TWO_SIDED|90.0|-11.17|14.01||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.01|-11.17|0.8523
71696898|NCT02175121|142909441|SUPERIORITY_OR_OTHER||Mean Difference (Net)|6.3|STANDARD_ERROR_OF_MEAN|7.73||0.4166|TWO_SIDED|90.0|-6.49|19.08||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.08|-6.49|0.4166
71696899|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.22||0.8516|TWO_SIDED|90.0|-4.73|5.93||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.93|-4.73|0.8516
71696900|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.97|STANDARD_ERROR_OF_MEAN|3.29||0.2303|TWO_SIDED|90.0|-1.48|9.42||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||9.42|-1.48|0.2303
71696901|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.19|STANDARD_ERROR_OF_MEAN|3.22||0.7132|TWO_SIDED|90.0|-4.15|6.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.52|-4.15|0.7132
71696902|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.74|STANDARD_ERROR_OF_MEAN|3.28||0.0034|TWO_SIDED|90.0|4.32|15.16||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||15.16|4.32|0.0034
71696903|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.99|STANDARD_ERROR_OF_MEAN|2.96||0.7394|TWO_SIDED|90.0|-5.89|3.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||3.92|-5.89|0.7394
71696904|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.52|STANDARD_ERROR_OF_MEAN|3.03||0.8652|TWO_SIDED|90.0|-4.5|5.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.53|-4.50|0.8652
71696905|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.61|STANDARD_ERROR_OF_MEAN|2.97||0.837|TWO_SIDED|90.0|-4.3|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-4.30|0.8370
71696906|NCT02175121|142909442|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.59|STANDARD_ERROR_OF_MEAN|3.01||0.0018|TWO_SIDED|90.0|4.6|14.58||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||14.58|4.60|0.0018
71696907|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.12|STANDARD_ERROR_OF_MEAN|4.25||0.6182|TWO_SIDED|90.0|-9.15|4.91||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||4.91|-9.15|0.6182
71696908|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.66|STANDARD_ERROR_OF_MEAN|4.34||0.7028|TWO_SIDED|90.0|-5.52|8.84||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.84|-5.52|0.7028
71696909|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3|STANDARD_ERROR_OF_MEAN|4.25||0.9445|TWO_SIDED|90.0|-7.33|6.73||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.73|-7.33|0.9445
71696910|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.07|STANDARD_ERROR_OF_MEAN|4.32||0.0373|TWO_SIDED|90.0|1.93|16.21||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.21|1.93|0.0373
71696911|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|4.21||0.9448|TWO_SIDED|90.0|-7.25|6.67||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.67|-7.25|0.9448
71696912|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.37|STANDARD_ERROR_OF_MEAN|4.3||0.9312|TWO_SIDED|90.0|-6.74|7.49||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.49|-6.74|0.9312
71696913|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.11|STANDARD_ERROR_OF_MEAN|4.21||0.9791|TWO_SIDED|90.0|-7.07|6.85||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.85|-7.07|0.9791
71696914|NCT02175121|142909443|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.34|STANDARD_ERROR_OF_MEAN|4.28||0.0044|TWO_SIDED|90.0|5.26|19.41||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||19.41|5.26|0.0044
71696915|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.77|STANDARD_ERROR_OF_MEAN|3.96||0.6553|TWO_SIDED|90.0|-4.78|8.33||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||8.33|-4.78|0.6553
71696916|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.61|STANDARD_ERROR_OF_MEAN|4.05||0.2569|TWO_SIDED|90.0|-2.09|11.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||11.30|-2.09|0.2569
71696917|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|7.64|STANDARD_ERROR_OF_MEAN|3.96||0.0553|TWO_SIDED|90.0|1.09|14.18||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||14.18|1.09|0.0553
71696918|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|12.89|STANDARD_ERROR_OF_MEAN|4.01||0.0016|TWO_SIDED|90.0|6.26|19.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||19.53|6.26|0.0016
71696919|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.58|STANDARD_ERROR_OF_MEAN|3.58||0.8717|TWO_SIDED|90.0|-5.35|6.51||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||6.51|-5.35|0.8717
71696920|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.2|STANDARD_ERROR_OF_MEAN|3.66||0.743|TWO_SIDED|90.0|-4.86|7.26||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.26|-4.86|0.7430
71696921|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.56|STANDARD_ERROR_OF_MEAN|3.58||0.2041|TWO_SIDED|90.0|-1.36|10.48||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||10.48|-1.36|0.2041
71696922|NCT02175121|142909444|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.92|STANDARD_ERROR_OF_MEAN|3.63|<|0.0001|TWO_SIDED|90.0|8.92|20.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||20.92|8.92|<0.0001
71696923|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.13|STANDARD_ERROR_OF_MEAN|4.08||0.975|TWO_SIDED|90.0|-6.62|6.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||6.87|-6.62|0.9750
71696924|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.99|STANDARD_ERROR_OF_MEAN|4.16||0.3396|TWO_SIDED|90.0|-2.9|10.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||10.87|-2.90|0.3396
71696925|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.49|STANDARD_ERROR_OF_MEAN|4.07||0.7142|TWO_SIDED|90.0|-8.23|5.24||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||5.24|-8.23|0.7142
71696926|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.78|STANDARD_ERROR_OF_MEAN|4.14||0.0192|TWO_SIDED|90.0|2.94|16.63||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.||16.63|2.94|0.0192
71696927|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.84|STANDARD_ERROR_OF_MEAN|3.85||0.8277|TWO_SIDED|90.0|-7.2|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.52|-7.20|0.8277
71696928|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.57|STANDARD_ERROR_OF_MEAN|3.93||0.8857|TWO_SIDED|90.0|-5.93|7.06||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||7.06|-5.93|0.8857
71696929|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.57|STANDARD_ERROR_OF_MEAN|3.84||0.8824|TWO_SIDED|90.0|-6.93|5.79||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||5.79|-6.93|0.8824
71696930|NCT02175121|142909445|SUPERIORITY_OR_OTHER||Mean Difference (Net)|9.23|STANDARD_ERROR_OF_MEAN|3.9||0.0192|TWO_SIDED|90.0|2.77|15.69||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.||15.69|2.77|0.0192
71696931|NCT01251042|142909499|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Information about the size of the standard deviation (SD) for the change was obtained from an earlier study. The SD for the change from pre-operation until 24 hours after start of transfusion was 0.2305. Due to the imprecise measuring device (if values below 0.3 g/l) and the large SD, a non-inferiority margin (∆) of 0.2 g/l was decided to be used in this study, resulting in a total number of 42 evaluable subjects, i.e. 21 subjects per group.||||||0.6294||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.6294
71696932|NCT03886272|142909508|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|112.96||||0.0413|TWO_SIDED|90.0|102.7|124.26||P-value for ratio outside 80% -125%.|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as: T1/R1. Intra-individual geometric coefficient of variation (gCV) = 14.2|Relative bioavailability||124.26|102.70|0.0413
71696933|NCT03886272|142909508|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|115.49||||0.0776|TWO_SIDED|90.0|105.23|126.74||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.9.|Relative bioavailability||126.74|105.23|0.0776
71696934|NCT03886272|142909508|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|78.05||||0.6443|TWO_SIDED|90.0|69.71|87.38||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as Tc3/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||87.38|69.71|0.6443
71696935|NCT03886272|142909508|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|45.97||||1|TWO_SIDED|90.0|41.05|51.48||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative bioavailability||51.48|41.05|1.00
71696936|NCT03886272|142909509|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|144.62||||0.9485|TWO_SIDED|90.0|124.82|167.57||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 22.1|Relative bioavailability||167.57|124.82|0.9485
71696937|NCT03886272|142909509|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|129.69||||0.7813|TWO_SIDED|90.0|119.51|140.73||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted geometric mean is geometric mean adjusted by treatment. Ratio is calculated as T2/R2. Intra-individual geometric coefficient of variation (gCV) = 12.2.|Relative Bioavailability||140.73|119.51|0.7813
71696938|NCT03886272|142909509|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|75.09||||0.7616|TWO_SIDED|90.0|64.58|87.32||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/3. Intra-individual geometric coefficient of variation (gCV) = 23.5.|Relative Bioavailability||87.32|64.58|0.7616
71696939|NCT03886272|142909509|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|41.45||||1|TWO_SIDED|90.0|35.61|48.25||P-value for ratio outside 80% - 125%|ANOVA|The model includes fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3u/R3. Intra-individual geometric coefficient of variation = 23.5.|Relative Bioavailability||48.25|35.61|1.00
71696940|NCT03886272|142909510|OTHER||Adjusted Geometric Mean Ratio (T1/R1)[%]|111.11|STANDARD_DEVIATION|11.5||0.0092|TWO_SIDED|90.0|102.87|120.01||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T1/R1. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||120.01|102.87|0.0092
71696941|NCT03886272|142909510|OTHER||Adjusted Geometric Mean Ratio (T2/R2)[%]|114.13||||0.0442|TWO_SIDED|90.0|104.58|124.56||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T2/R2. Intra-individual geometric coefficient of variation (gCV) = 13.0.|Relative Bioavailability||124.56|104.58|0.0442
71761203|NCT00611026|143024040|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06|STANDARD_ERROR_OF_MEAN|0.0||0.1661|TWO_SIDED|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.||0.0|-0.2|0.1661
71696942|NCT03886272|142909510|OTHER||Adj. Geometric Mean Ratio (T3c/R3) [%]|80.1||||0.4928|TWO_SIDED|90.0|71.54|89.68||P-value for ratio outside 80% - 125%|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as = T3c/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||89.68|71.54|0.4928
71696943|NCT03886272|142909510|OTHER||Adj. Geometric Mean Ratio (T3u/R3) [%]|48.83||||1|TWO_SIDED|90.0|43.6|54.69||P-value for ratio outside 80% - 125%.|ANOVA|The model included fixed effects for 'sequence', 'period', and 'treatment'. 'Subjects within sequences' is included as random effect.|The Adjusted Geometric Mean is geometric mean adjusted by treatment. Ratio is calculated as T3u/R3. Intra-individual geometric coefficient of variation (gCV) = 17.6.|Relative Bioavailability||54.69|43.60|1.00
71696944|NCT00931632|142909511|SUPERIORITY_OR_OTHER|||||||0.427|TWO_SIDED||||||Mantel Haenszel|||||||0.427
71696945|NCT01687218|142909526|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|1.03||||0.88|TWO_SIDED|95.0|0.73|1.44|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.44|0.73|0.88
71696946|NCT01687218|142909526|SUPERIORITY_OR_OTHER_LEGACY||Risk Ratio (RR)|0.88||||0.43|TWO_SIDED|95.0|0.64|1.21|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.||1.21|0.64|0.43
71696947|NCT01687218|142909527|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.28|||<|0.0001|TWO_SIDED|95.0|0.15|0.5|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.50|0.15|<0.0001
71696948|NCT01687218|142909527|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.37||||0.002|TWO_SIDED|95.0|0.2|0.7|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.70|0.20|0.002
71696949|NCT01687218|142909528|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.56||||0.08|TWO_SIDED|95.0|0.29|1.08|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.08|0.29|0.08
71696950|NCT01687218|142909528|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.76||||0.46|TWO_SIDED|95.0|0.37|1.56|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.56|0.37|0.46
71696951|NCT01687218|142909529|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.38||||0.0004|TWO_SIDED|95.0|0.22|0.65|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||0.65|0.22|0.0004
71696952|NCT01687218|142909529|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|0.7||||0.23|TWO_SIDED|95.0|0.39|1.25|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.||1.25|0.39|0.23
71696953|NCT01687218|142909530|OTHER||Slope|-1.41|||<|0.001|TWO_SIDED|95.0|-1.53|-1.3|||Mixed Models Analysis||This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.30|-1.53|<0.001
71696954|NCT01687218|142909530|OTHER||Slope|-1.82|||<|0.001|TWO_SIDED|95.0|-1.95|-1.7|||Mixed Models Analysis||This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-1.70|-1.95|<0.001
71696955|NCT01687218|142909531|SUPERIORITY||Slope|0.66|||<|0.001|TWO_SIDED|95.0|0.49|0.83|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.83|0.49|<0.001
71696956|NCT01687218|142909531|SUPERIORITY||Slope|-0.16||||0.31|TWO_SIDED|95.0|-0.46|0.15|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.15|-0.46|0.31
71696957|NCT01687218|142909532|SUPERIORITY||Slope|0.3||||0.004|TWO_SIDED|95.0|0.1|0.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.||0.50|0.10|0.004
71696958|NCT01687218|142909532|SUPERIORITY||Slope|-0.7|||<|0.001|TWO_SIDED|95.0|-0.92|-0.47|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||-0.47|-0.92|<0.001
71696959|NCT01687218|142909533|SUPERIORITY||Slope|-2.66|||<|0.001|TWO_SIDED|95.0|-2.82|-2.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.50|-2.82|<0.001
71696960|NCT01687218|142909533|SUPERIORITY||Slope|-2.65|||<|0.001|TWO_SIDED|95.0|-2.81|-2.49|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.||-2.49|-2.81|<0.001
71696961|NCT01687218|142909534|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
71696962|NCT01687218|142909534|SUPERIORITY||Slope|-0.91|||<|0.001|TWO_SIDED|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.||-0.80|-1.01|<0.001
71696963|NCT01687218|142909535|SUPERIORITY||Slope|-2.0|||<|0.001|TWO_SIDED|95.0|-2.16|-1.84|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.84|-2.16|<0.001
71696964|NCT01687218|142909535|SUPERIORITY||Slope|-1.9|||<|0.001|TWO_SIDED|95.0|-2.07|-1.74|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.||-1.74|-2.07|<0.001
71696965|NCT01687218|142909536|SUPERIORITY||Slope|0.54|||<|0.001|TWO_SIDED|95.0|0.35|0.72|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.72|0.35|<0.001
71696966|NCT01687218|142909536|SUPERIORITY||Slope|0.01||||0.92|TWO_SIDED|95.0|-0.28|0.31|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.||0.31|-0.28|0.92
71696967|NCT01687218|142909537|SUPERIORITY||Odds Ratio (OR)|0.35||||0.0005|TWO_SIDED|95.0|0.19|0.63|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||0.63|0.19|0.0005
71696968|NCT01687218|142909537|SUPERIORITY||Odds Ratio (OR)|0.89||||0.74|TWO_SIDED|95.0|0.43|1.81|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into\<80% adherence versus\>80% adherence.||1.81|0.43|0.74
71696969|NCT01257347|142909570|SUPERIORITY_OR_OTHER||||||<=|0.001||||||We included a stopping rule in which recruitment would be stopped at the midpoint for futility if the z-score was negative or for efficacy if the z-score was positive and the p-value ≤ 0.001.|GEE model|GEE models (logit link) with clinician as the cluster variable, appropriateness of management as outcome, intervention group as explanatory variable.||The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.||||<=0.001
71696970|NCT03204643|142909574|SUPERIORITY||Odds Ratio (OR)|0.74||||0.06|TWO_SIDED|95.0|0.54|1.02|||Regression, Logistic|||||1.02|0.54|0.06
71696971|NCT03204643|142909575|SUPERIORITY||Odds Ratio (OR)|1.07||||0.76|TWO_SIDED|95.0|0.7|1.64|||Mixed Models Analysis|||||1.64|0.70|0.76
71696972|NCT03204643|142909576|SUPERIORITY||Odds Ratio (OR)|1.16||||0.62|TWO_SIDED|95.0|0.65|2.08|||Mixed Models Analysis|||||2.08|0.65|0.62
71696973|NCT03204643|142909577|SUPERIORITY||Odds Ratio (OR)|1.35||||0.08|TWO_SIDED|0.96|0.96|1.9|||Mixed Models Analysis|||||1.90|0.96|0.08
71696974|NCT03533751|142909599|SUPERIORITY||Least Squares (LS) Mean Difference|7.75|STANDARD_ERROR_OF_MEAN|10.235||0.4498|TWO_SIDED|95.0|-12.4066|27.8983|||ANCOVA|The p-value was obtained using a mixed effect analysis of covariance (ANCOVA) model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||27.8983|-12.4066|0.4498
71696975|NCT03533751|142909599|SUPERIORITY||LS Mean Difference|-6.32|STANDARD_ERROR_OF_MEAN|9.39||0.501|TWO_SIDED|95.0|-24.774|12.1262|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||12.1262|-24.7740|0.5010
71696976|NCT03533751|142909599|SUPERIORITY||LS Mean Difference|1.97|STANDARD_ERROR_OF_MEAN|9.454||0.8349|TWO_SIDED|95.0|-16.6037|20.5476|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||20.5476|-16.6037|0.8349
71696977|NCT03533751|142909599|SUPERIORITY||LS Mean Difference|4.82|STANDARD_ERROR_OF_MEAN|11.154||0.6662|TWO_SIDED|95.0|-17.1892|26.8275|||ANCOVA|The p-value was obtained using a mixed effect ANCOVA model with treatment as fixed effect and Baseline EASI as covariate.|Difference = Etokimab - Placebo|||26.8275|-17.1892|0.6662
71696978|NCT03533751|142909600|SUPERIORITY||Odds Ratio (OR)|0.91||||0.7992|TWO_SIDED|95.0|0.42|1.9509|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.9509|0.4200|0.7992
71696979|NCT03533751|142909600|SUPERIORITY||Odds Ratio (OR)|1.59||||0.2197|TWO_SIDED|95.0|0.757|3.3572|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.3572|0.7570|0.2197
71696980|NCT03533751|142909600|SUPERIORITY||Odds Ratio (OR)|1.15||||0.7197|TWO_SIDED|95.0|0.5345|2.4774|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.4774|0.5345|0.7197
71696981|NCT03533751|142909600|SUPERIORITY||Odds Ratio (OR)|0.85||||0.6772|TWO_SIDED|95.0|0.391|1.8404|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||1.8404|0.3910|0.6772
71696982|NCT03533751|142909601|SUPERIORITY||Odds Ratio (OR)|1.03||||0.9537|TWO_SIDED|95.0|0.3922|2.6994|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||2.6994|0.3922|0.9537
71696983|NCT03533751|142909601|SUPERIORITY||Odds Ratio (OR)|1.57||||0.3316|TWO_SIDED|95.0|0.6323|3.8895|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.8895|0.6323|0.3316
71696984|NCT03533751|142909601|SUPERIORITY||Odds Ratio (OR)|1.36||||0.5166|TWO_SIDED|95.0|0.5331|3.4944|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.4944|0.5331|0.5166
71696985|NCT03533751|142909601|SUPERIORITY||Odds Ratio (OR)|1.17||||0.7426|TWO_SIDED|95.0|0.4545|3.0223|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||3.0223|0.4545|0.7426
71696986|NCT03533751|142909602|SUPERIORITY||Odds Ratio (OR)|1.76||||0.4543|TWO_SIDED|95.0|0.3998|7.7615|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||7.7615|0.3998|0.4543
71696987|NCT03533751|142909602|SUPERIORITY||Odds Ratio (OR)|2.57||||0.1874|TWO_SIDED|95.0|0.6314|10.4827|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||10.4827|0.6314|0.1874
71696988|NCT03533751|142909602|SUPERIORITY||Odds Ratio (OR)|2.69||||0.1721|TWO_SIDED|95.0|0.6506|11.0814|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||11.0814|0.6506|0.1721
71696989|NCT03533751|142909602|SUPERIORITY||Odds Ratio (OR)|0.68||||0.6755|TWO_SIDED|95.0|0.1086|4.2141|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline EASI as a covariate.||||4.2141|0.1086|0.6755
71696990|NCT03533751|142909603|SUPERIORITY||Odds Ratio (OR)|0.75||||0.6058|TWO_SIDED|95.0|0.2481|2.2543|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||2.2543|0.2481|0.6058
71696991|NCT03533751|142909603|SUPERIORITY||Odds Ratio (OR)|0.97||||0.9521|TWO_SIDED|95.0|0.3356|2.7923|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.7923|0.3356|0.9521
71696992|NCT03533751|142909603|SUPERIORITY||Odds Ratio (OR)|1.23||||0.6905|TWO_SIDED|95.0|0.4457|3.3878|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||3.3878|0.4457|0.6905
71696993|NCT03533751|142909603|SUPERIORITY||Odds Ratio (OR)|1.04||||0.9399|TWO_SIDED|95.0|0.3671|2.9518|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as a covariate.||||2.9518|0.3671|0.9399
71696994|NCT03533751|142909604|SUPERIORITY||Odds Ratio (OR)|1.22||||0.7659|TWO_SIDED|95.0|0.329|4.5268|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline vIGA-AD score as covariate.||||4.5268|0.3290|0.7659
71696995|NCT03533751|142909604|SUPERIORITY||Odds Ratio (OR)|1.36||||0.6273|TWO_SIDED|95.0|0.3895|4.776|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||4.7760|0.3895|0.6273
71696996|NCT03533751|142909604|SUPERIORITY||Odds Ratio (OR)|1.88||||0.2967|TWO_SIDED|95.0|0.5734|6.1879|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||6.1879|0.5734|0.2967
71696997|NCT03533751|142909604|SUPERIORITY||Odds Ratio (OR)|1.46||||0.5544|TWO_SIDED|95.0|0.4152|5.1476|||Regression, Logistic|Logistic regression model with treatment as fixed effect and baseline vIGA-AD score as covariate.||||5.1476|0.4152|0.5544
71696998|NCT03533751|142909605|SUPERIORITY||Odds Ratio (OR)|1.12||||0.86|TWO_SIDED|95.0|0.3175|3.9513|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||3.9513|0.3175|0.8600
71696999|NCT03533751|142909605|SUPERIORITY||Odds Ratio (OR)|1.84||||0.3222|TWO_SIDED|95.0|0.5511|6.1214|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1214|0.5511|0.3222
71697000|NCT03533751|142909605|SUPERIORITY||Odds Ratio (OR)|1.98||||0.2564|TWO_SIDED|95.0|0.6089|6.431|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.4310|0.6089|0.2564
71697001|NCT03533751|142909605|SUPERIORITY||Odds Ratio (OR)|1.89||||0.2912|TWO_SIDED|95.0|0.5806|6.1275|||Regression, Logistic|Logistic regression model with treatment as fixed effect and Baseline peak weekly averaged NRS as covariate.||||6.1275|0.5806|0.2912
71697002|NCT03533751|142909606|SUPERIORITY||LS Mean Difference|-1.17|STANDARD_ERROR_OF_MEAN|8.679||0.8927|TWO_SIDED|95.0|-18.2117|15.8686|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||15.8686|-18.2117|0.8927
71697003|NCT03533751|142909606|SUPERIORITY||LS Mean Difference|3.43|STANDARD_ERROR_OF_MEAN|9.019||0.7035|TWO_SIDED|95.0|-14.2767|21.1463|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||21.1463|-14.2767|0.7035
71697004|NCT03533751|142909606|SUPERIORITY||LS Mean Difference|-9.27|STANDARD_ERROR_OF_MEAN|8.608||0.2819|TWO_SIDED|95.0|-26.159|7.6237|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||7.6237|-26.1590|0.2819
71697005|NCT03533751|142909606|SUPERIORITY||LS Mean Difference|-6.06|STANDARD_ERROR_OF_MEAN|8.557||0.4793|TWO_SIDED|95.0|-22.8452|10.7333|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline weekly averaged peak NRS as covariate.|Difference = Etokimab - Placebo|||10.7333|-22.8452|0.4793
71697006|NCT03533751|142909607|SUPERIORITY||LS Mean Difference|6.57|STANDARD_ERROR_OF_MEAN|6.677||0.3262|TWO_SIDED|95.0|-6.5723|19.7054|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||19.7054|-6.5723|0.3262
71697007|NCT03533751|142909607|SUPERIORITY||LS Mean Difference|-1.23|STANDARD_ERROR_OF_MEAN|6.366||0.8465|TWO_SIDED|95.0|-13.7439|11.2782|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||11.2782|-13.7439|0.8465
71697008|NCT03533751|142909607|SUPERIORITY||LS Mean Difference|2.51|STANDARD_ERROR_OF_MEAN|6.396||0.6947|TWO_SIDED|95.0|-10.0587|15.082|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.||||15.0820|-10.0587|0.6947
71697009|NCT03533751|142909607|SUPERIORITY||LS Mean Difference|6.76|STANDARD_ERROR_OF_MEAN|6.909||0.3288|TWO_SIDED|95.0|-6.8451|20.3626|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline SCORAD as covariate.|Difference = Etokimab - Placebo|||20.3626|-6.8451|0.3288
71697010|NCT03533751|142909608|SUPERIORITY||LS Mean Difference|0.26|STANDARD_ERROR_OF_MEAN|1.355||0.8497|TWO_SIDED|95.0|-2.4081|2.9218|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.9218|-2.4081|0.8497
71697011|NCT03533751|142909608|SUPERIORITY||LS Mean Difference|-0.91|STANDARD_ERROR_OF_MEAN|1.35||0.5016|TWO_SIDED|95.0|-3.5636|1.7473|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||1.7473|-3.5636|0.5016
71697012|NCT03533751|142909608|SUPERIORITY||LS Mean Difference|-0.44|STANDARD_ERROR_OF_MEAN|1.386||0.7511|TWO_SIDED|95.0|-3.167|2.287|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||2.2870|-3.1670|0.7511
71697013|NCT03533751|142909608|SUPERIORITY||LS Mean Difference|0.43|STANDARD_ERROR_OF_MEAN|1.396||0.7558|TWO_SIDED|95.0|-2.3133|3.1824|||ANCOVA|Mixed effect ANCOVA model with treatment as fixed effect and Baseline DLQI score as covariate.|Difference = Etokimab - Placebo|||3.1824|-2.3133|0.7558
71697014|NCT00368251|142909612|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.15|||=|0.942|TWO_SIDED|95.0|-26.12|24.96||All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo was calculated.|"The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.~The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.~The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power."||24.96|-26.12|=0.942
71697015|NCT00368251|142909612|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|-18.05|||=|0.105|TWO_SIDED|95.0|-39.31|4.86||Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||4.86|-39.31|=0.105
71697016|NCT00368251|142909613|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|1.24|||=|0.672|TWO_SIDED|95.0|-21.9|31.06||Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).|Difference versus Placebo.|If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.||31.06|-21.90|=0.672
71761204|NCT00611026|143024041|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||0.0021
71697017|NCT00368251|142909613|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.806|TWO_SIDED|95.0|-33.33|18.75||Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|"In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:~* Functional Disability~* Stimulus Sensitivity~* Myoclonus Patient Questionnaire"||18.75|-33.33|=0.806
71697018|NCT00368251|142909614|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.549|TWO_SIDED|95.0|-25.0|100.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Willcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||100.00|-25.00|=0.549
71697019|NCT00368251|142909614|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|0.0|||=|0.654|TWO_SIDED|95.0|-50.0|66.67||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||66.67|-50.00|=0.654
71697020|NCT00368251|142909615|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|14.29|||=|0.037|TWO_SIDED|95.0|-1.76|39.39||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||39.39|-1.76|=0.037
71697021|NCT00368251|142909615|SUPERIORITY_OR_OTHER_LEGACY||Hodges-Lehmann-estimator of difference|10.0|||=|0.111|TWO_SIDED|95.0|-5.56|30.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|||30.00|-5.56|=0.111
71697022|NCT00368251|142909616|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.931||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||||||=0.931
71697023|NCT00368251|142909616|SUPERIORITY_OR_OTHER_LEGACY||||||=|0.253||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||P-value for pairwise comparison of each Brivaracetam dose versus Placebo.||||=0.253
71697024|NCT00607893|142909621|OTHER||Mean Difference (Final Values)|0.071||||0.38|TWO_SIDED|95.0|-0.09|0.23|||Regression, Linear||F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.23|-0.090|0.38
71697025|NCT00607893|142909622|OTHER||Mean Difference (Final Values)|1.83||||0.85|TWO_SIDED|95.0|-17.42|21.07|||Regression, Linear|||||21.07|-17.42|0.85
71697026|NCT00607893|142909623|OTHER||Mean Difference (Final Values)|0.14||||0.92|TWO_SIDED|95.0|-2.6|2.87|||Regression, Linear|||||2.87|-2.60|0.92
71697027|NCT00607893|142909624|OTHER||Mean Difference (Final Values)|0.21||||0.55|TWO_SIDED|95.0|-0.48|0.91|||Regression, Linear|||||0.91|-0.48|0.55
71697028|NCT00607893|142909625|OTHER||Mean Difference (Final Values)|0.38||||0.17|TWO_SIDED|95.0|-0.16|0.92|||Regression, Linear|||||0.92|-0.16|0.17
71697029|NCT00607893|142909626|OTHER||Mean Difference (Final Values)|2.4||||0.076|TWO_SIDED|95.0|-0.26|5.07|||Regression, Linear|||||5.07|-0.26|0.076
71697030|NCT00607893|142909627|OTHER||Mean Difference (Final Values)|0.062||||0.019|TWO_SIDED|95.0|0.01|0.11|||Regression, Linear||sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.|||0.11|0.010|0.019
71697031|NCT00607893|142909628|OTHER||Mean Difference (Final Values)|0.17||||0.68|TWO_SIDED|95.0|-0.64|0.99|||Regression, Linear|||||0.99|-0.64|0.68
71697032|NCT00607893|142909629|OTHER||Mean Difference (Final Values)|1.35||||0.59|TWO_SIDED|95.0|-3.6|6.31|||Regression, Linear|||||6.31|-3.60|0.59
71697033|NCT00607893|142909630|OTHER||Mean Difference (Final Values)|6.93|||<|0.001|TWO_SIDED|95.0|3.04|10.81|||Regression, Linear|||||10.81|3.04|<0.001
71697034|NCT02669849|142909631|SUPERIORITY||Least Squares (LS) Mean Difference|-0.69||||0.7519|TWO_SIDED|95.0|-5.08|3.69|||Mixed-effects model for repeated measure|||||3.69|-5.08|0.7519
71697035|NCT02543840|142909640|SUPERIORITY||Mean Difference (Final Values)|0.2|||<|0.01|TWO_SIDED|95.0|-1.26|1.5||Adjusted for multiple comparisons (Bonferroni four comparisons).|Mixed Models Analysis|||||1.5|-1.26|<0.01
71697036|NCT02543840|142909640|SUPERIORITY||Mean Difference (Final Values)|5.03|||<|0.001|TWO_SIDED|95.0|2.24|7.82||Adjusted for comparisons (Bonferroni for 4 comparisons.)|Regression, Linear|||Among Veteran participants,we used a linear contrast comparing a) those with complex clinical presentations, defined as receiving treatment for three or more mental health diagnoses in the prior year to b) those with two or fewer diagnoses during the facilitation year from T0 to T12..||7.82|2.24|<0.001
71697037|NCT02543840|142909641|SUPERIORITY||Mean Difference (Final Values)|1.2|||<|0.04|TWO_SIDED|95.0|0.04|2.3||Adjusted for comparison (Bonferroni for four comparisons.)|Mixed Models Analysis|||||2.3|0.04|<0.04
71697038|NCT02543840|142909642|SUPERIORITY||Mean Difference (Final Values)|0.6|||>|0.05|TWO_SIDED|95.0|-0.2|0.9|||Mixed Models Analysis|||||0.9|-0.2|>0.05
71697039|NCT02543840|142909643|SUPERIORITY||Mean Difference (Final Values)|0.5|||>|0.05|TWO_SIDED|95.0|-1.3|2.3|||Mixed Models Analysis|||||2.3|-1.3|>0.05
71697040|NCT02543840|142909644|SUPERIORITY||Mean Difference (Final Values)|0.0|||>|0.05|TWO_SIDED|95.0|-0.6|0.8|||Mixed Models Analysis|||||0.8|-0.6|>0.05
71697041|NCT02543840|142909645|SUPERIORITY||Mean Difference (Final Values)|0.005|||>|0.05|TWO_SIDED|95.0|-0.074|0.084|||t-test, 2 sided|Paired.||||0.084|-0.074|>0.05
71697042|NCT02543840|142909646|SUPERIORITY||Mean Difference (Final Values)|0.011|STANDARD_DEVIATION|0.206|>|0.05|TWO_SIDED|95.0|-0.056|0.077|||t-test, 2 sided|Paired.||||0.077|-0.056|>0.05
71697043|NCT02543840|142909647|SUPERIORITY||Mean Difference (Final Values)|0.153|||<|0.001|TWO_SIDED|95.0|0.044|0.262|||t-test, 2 sided|Paired||||0.262|0.044|<0.001
71697044|NCT02543840|142909648|SUPERIORITY||Mean Difference (Final Values)|0.186|||<|0.01|TWO_SIDED|95.0|0.083|0.289|||t-test, 2 sided|Paired.||||0.289|0.083|<0.01
71697045|NCT02543840|142909649|SUPERIORITY||Mean Difference (Final Values)|-0.12|||<|0.001|TWO_SIDED|95.0|-0.16|-0.07||Repeated patient binary outcome models for hospitalized (0/1) across 8 quarters.|Mixed Models Analysis|Adjusted (Bonferroni four comparisons).||||-0.07|-0.16|<0.001
71697046|NCT04745351|142909650|SUPERIORITY||Hazard Ratio (HR)|0.816||||0.6132|TWO_SIDED|95.0|0.504|1.321||P-value was calculated from stratified log-rank test, stratified by the baseline stratification factors.|Log Rank|||||1.321|0.504|0.6132
71697047|NCT04745351|142909651|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.3881|TWO_SIDED|95.0|0.497|1.388||P-value was calculated from stratified log-rank test stratified by the baseline stratification factors.|Log Rank|||||1.388|0.497|0.3881
71697048|NCT04745351|142909652|SUPERIORITY||Hazard Ratio (HR)|1.043||||0.9116|TWO_SIDED|95.0|0.493|2.207||The treatment effect p-value was calculated using Cox model with death as the competing risk and baseline stratification factors as covariates.|Regression, Cox|||||2.207|0.493|0.9116
71697049|NCT04745351|142909655|SUPERIORITY|||||||0.8541||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.8541
71697050|NCT04745351|142909656|SUPERIORITY|||||||0.4974||||||P-value was analysed from proportional odds model including treatment as the independent variable.|Proportional odds model|||||||0.4974
71697051|NCT04745351|142909657|SUPERIORITY|||||||0.4283||||||P-value was calculated based on Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||||||0.4283
71697052|NCT04745351|142909658|SUPERIORITY||Relative risk|0.89||||0.2773|TWO_SIDED|95.0|0.731|1.091||The treatment effect p-value was calculated using Cochran-Mantel-Haenszel (CMH) analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.091|0.731|0.2773
71697053|NCT04745351|142909659|SUPERIORITY||Relative risk|0.97||||0.7538|TWO_SIDED|95.0|0.819|1.155||The treatment effect p-value was calculated using CMH analysis including baseline stratification factors.|Cochran-Mantel-Haenszel|||||1.155|0.819|0.7538
71697054|NCT01248416|142909662|SUPERIORITY||||||<|0.006|||||||ANCOVA|||||||<0.006
71697055|NCT01248416|142909664|SUPERIORITY|||||||0.906|||||||ANOVA|||||||0.906
71697056|NCT01248416|142909665|SUPERIORITY|||||||0.015|||||||ANOVA|||||||0.015
71697057|NCT01248416|142909667|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71697058|NCT01248416|142909668|SUPERIORITY||||||<|0.0001|||||||ANOVA|||||||<0.0001
71697059|NCT01248416|142909669|SUPERIORITY|||||||0.0003|||||||ANCOVA|||||||0.0003
71697060|NCT03499795|142909675|SUPERIORITY|||||||0.8633|||||||Clopper-Pearson|P-value was calculated based on the exact method of Clopper-Pearson and superiority was concluded if the one-sided p-value is \<0.05.||||||0.8633
71697061|NCT02741284|142909687|NON_INFERIORITY|A noninferiority margin of 30% (mean difference \<1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity|Mean Difference (Final Values)|0.1||||0.69|TWO_SIDED|95.0|-0.5|0.7|||Wilcoxon (Mann-Whitney)|||||0.7|-0.5|0.69
71697062|NCT02741284|142909688|NON_INFERIORITY|Noninferiority margin 30%|Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.03|||t-test, 2 sided|||pH||0.03|-0.01|<0.05
71697063|NCT02741284|142909689|SUPERIORITY||Risk Ratio (RR)|0.32|||<|0.05|TWO_SIDED|95.0|0.07|1.48|||Chi-squared|||Cesarean delivery||1.48|0.07|<0.05
71697064|NCT02741284|142909689|SUPERIORITY||Risk Ratio (RR)|0.0|||<|0.05|TWO_SIDED|95.0|0.0|0.0|||Chi-squared|||Cesarean delivery for non reassuring fetal status||0|0|<0.05
71697065|NCT02741284|142909689|SUPERIORITY||Risk Ratio (RR)|5.65|||<|0.05|TWO_SIDED|95.0|0.71|45.2|||Chi-squared|||Operative vaginal delivery||45.20|0.71|<0.05
71697066|NCT02741284|142909690|SUPERIORITY||Mean Difference (Net)|-1.5||||0.44|TWO_SIDED|95.0|-5.4|2.4|||t-test, 2 sided|||||2.4|-5.4|0.44
71697067|NCT02741284|142909691|SUPERIORITY||Mean Difference (Net)|-4.7||||0.06|TWO_SIDED|95.0|-9.6|0.1|||t-test, 2 sided|||||0.1|-9.6|0.06
71697068|NCT02741284|142909692|SUPERIORITY||Mean Difference (Net)|0.0||||0.99|TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1.0|-1.0|0.99
71697069|NCT01516216|142909701|SUPERIORITY|||||||0.07|||||||Log Rank|||||||0.07
71697070|NCT01516216|142909702|SUPERIORITY|||||||0.43|||||||Log Rank|||||||0.43
71697071|NCT01516216|142909703|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71697072|NCT01516216|142909705|SUPERIORITY|||||||0.68|||||||Chi-squared|||||||0.68
71697073|NCT01516216|142909708|SUPERIORITY|||||||0.9801|||||||Chi-squared|||||||0.9801
71697074|NCT01516216|142909709|SUPERIORITY|||||||0.7444|||||||Chi-squared|||||||0.7444
71697075|NCT00879190|142909710|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||||||1.0
71697076|NCT00879190|142909711|SUPERIORITY_OR_OTHER|||||||0.03|||||||Fisher Exact|||||||0.03
71697077|NCT00879190|142909712|SUPERIORITY_OR_OTHER|||||||0.6|||||||Fisher Exact|||||||0.6
71697078|NCT01603602|142909713|SUPERIORITY||Least Squares (LS) Mean Difference|-0.66|||<|0.001|TWO_SIDED|95.0|-0.938|-0.379||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|Mixed Model Repeated Measures (MMRM)|||||-0.379|-0.938|<0.001
71697079|NCT01603602|142909713|SUPERIORITY||LS Mean Difference|-0.71|||<|0.001|TWO_SIDED|95.0|-0.992|-0.426||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||-0.426|-0.992|<0.001
71697080|NCT01603602|142909714|SUPERIORITY||LS Mean Difference|0.21||||0.155|TWO_SIDED|95.0|-0.082|0.511||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.511|-0.082|0.155
71697081|NCT01603602|142909714|SUPERIORITY||LS Mean Difference|0.22||||0.147|TWO_SIDED|95.0|-0.079|0.523||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM|||||0.523|-0.079|0.147
71697082|NCT01603602|142909715|SUPERIORITY||LS Mean Difference|-0.39||||0.111|TWO_SIDED|95.0|-0.861|0.091||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.091|-0.861|0.111
71697083|NCT01603602|142909715|SUPERIORITY||LS Mean Difference|-0.44||||0.078|TWO_SIDED|95.0|-0.933|0.051||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||||0.051|-0.933|0.078
71697084|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|-0.1||||0.636|TWO_SIDED|95.0|-0.498|0.305||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.305|-0.498|0.636
71697085|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|-0.09||||0.658|TWO_SIDED|95.0|-0.502|0.318||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal||0.318|-0.502|0.658
71697086|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|0.24||||0.243|TWO_SIDED|95.0|-0.162|0.635||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.635|-0.162|0.243
71697087|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|0.17||||0.412|TWO_SIDED|95.0|-0.237|0.576||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal||0.576|-0.237|0.412
71697088|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|-0.02||||0.904|TWO_SIDED|95.0|-0.408|0.361||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.361|-0.408|0.904
71697089|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|-0.25||||0.2|TWO_SIDED|95.0|-0.641|0.135||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal||0.135|-0.641|0.200
71697090|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|0.59||||0.003|TWO_SIDED|95.0|0.21|0.978||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.978|0.210|0.003
71697091|NCT01603602|142909716|SUPERIORITY||LS Mean Difference|0.19||||0.327|TWO_SIDED|95.0|-0.194|0.58||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal||0.580|-0.194|0.327
71697092|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|12.1||||0.117|TWO_SIDED|95.0|-3.089|27.293||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||27.293|-3.089|0.117
71697093|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|8.41||||0.273|TWO_SIDED|95.0|-6.717|23.527||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow||23.527|-6.717|0.273
71697094|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|14.71||||0.015|TWO_SIDED|95.0|2.958|26.458||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||26.458|2.958|0.015
71697095|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|11.85||||0.046|TWO_SIDED|95.0|0.203|23.504||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow||23.504|0.203|0.046
71697096|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|20.97|||<|0.001|TWO_SIDED|95.0|8.801|33.137||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||33.137|8.801|<0.001
71697097|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|11.35||||0.064|TWO_SIDED|95.0|-0.662|23.362||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow||23.362|-0.662|0.064
71697098|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|15.25||||0.013|TWO_SIDED|95.0|3.317|27.178||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||27.178|3.317|0.013
71697099|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|7.22||||0.225|TWO_SIDED|95.0|-4.488|18.934||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow||18.934|-4.488|0.225
71697100|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|4.5||||0.409|TWO_SIDED|95.0|-6.239|15.236||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||15.236|-6.239|0.409
71697101|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|3.86||||0.47|TWO_SIDED|95.0|-6.69|14.419||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow||14.419|-6.690|0.470
71697102|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-6.13||||0.263|TWO_SIDED|95.0|-16.962|4.706||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||4.706|-16.962|0.263
71697103|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-14.6||||0.012|TWO_SIDED|95.0|-25.846|-3.36||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist||-3.360|-25.846|0.012
71697104|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-10.64||||0.098|TWO_SIDED|95.0|-23.277|1.996||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||1.996|-23.277|0.098
71697105|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-13.1||||0.051|TWO_SIDED|95.0|-26.26|0.068||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist||0.068|-26.260|0.051
71697106|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-17.11||||0.01|TWO_SIDED|95.0|-30.031|-4.189||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||-4.189|-30.031|0.010
71697107|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-11.25||||0.098|TWO_SIDED|95.0|-24.622|2.131||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist||2.131|-24.622|0.098
71697108|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-17.71||||0.005|TWO_SIDED|95.0|-29.888|-5.537||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-5.537|-29.888|0.005
71697109|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-15.74||||0.015|TWO_SIDED|95.0|-28.293|-3.194||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist||-3.194|-28.293|0.015
71697110|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-15.25||||0.02|TWO_SIDED|95.0|-28.01|-2.492||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-2.492|-28.010|0.020
71697111|NCT01603602|142909717|SUPERIORITY||LS Mean Difference|-13.52||||0.046|TWO_SIDED|95.0|-26.797|-0.243||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist||-0.243|-26.797|0.046
71697112|NCT01935089|142909726|OTHER|"Hypothesis: 20 weeks of treatment (baseline week 3 to endpoint week 24) will result in a change in the levels of integrated HIV-1 DNA (copies/CD4 T cell Variable name: intDNA).~Test if the mean difference (IntDNA wk24 - IntDNAwk3) is significantly different from zero (i.e. no change) Null hypothesis: Mean (IntDNA wk24 - IntDNAwk3) = 0; reject if p\<0.05"||||||0.0797||||||significant if \<0.05|signed rank test|||||||0.0797
71697113|NCT00723229|142909772|SUPERIORITY_OR_OTHER||Incidence Risk Ratio|0.2|||<|0.001|TWO_SIDED|95.0|0.17|0.25|||Regression, poisson|Adjusted for period effects.||The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.||0.25|0.17|<0.001
71697114|NCT00723229|142909772|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.05|||<|0.001|TWO_SIDED|95.0|0.03|0.08|||Regression, Poisson|||Among HIV seronegative individuals.||0.08|0.03|<0.001
71697115|NCT00723229|142909772|SUPERIORITY|Adjusted for period effects.|Risk Ratio (RR)|0.5|||<|0.001|TWO_SIDED|95.0|0.4|0.6|||Regression, Poisson|||Among HIV seropositive individuals.||0.6|0.4|<0.001
71697116|NCT01079780|142909783|SUPERIORITY||Hazard Ratio (HR)|0.75|||||TWO_SIDED|||||||||||||
71697117|NCT01079780|142909784|SUPERIORITY|||||||0.27|||||||Chi-squared|||||||0.27
71697118|NCT01079780|142909786|SUPERIORITY||Hazard Ratio (HR)|0.86||||0.55|TWO_SIDED||||||Log Rank|||||||0.55
71697119|NCT01668797|142909809|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.||The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 1:1 (brexpiprazole:placebo) randomization ratio.||||<0.0001
71697120|NCT01668797|142909810|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Chi-squared|||The percentage of participants with impending relapse in treatment groups (Brexpiprazole and placebo) in final analysis for participants meeting at least one of the criteria.||||<0.0001
71697121|NCT01668797|142909811|SUPERIORITY_OR_OTHER|||||||0.2296|||||||Chi-squared|||Statistical analysis at Week 6.||||0.2296
71697122|NCT01668797|142909811|SUPERIORITY_OR_OTHER|||||||0.2051|||||||Chi-squared|||Statistical analysis at Week 12.||||0.2051
71697123|NCT01668797|142909811|SUPERIORITY_OR_OTHER|||||||0.7354|||||||Chi-squared|||Statistical analysis at Week 24.||||0.7354
71697124|NCT01668797|142909811|SUPERIORITY_OR_OTHER|||||||0.1977|||||||Chi-squared|||Statistical analysis at Week 36.||||0.1977
71697125|NCT01668797|142909811|SUPERIORITY_OR_OTHER|||||||0.8734|||||||Chi-squared|||Statistical analysis at Week 52.||||0.8734
71697126|NCT01668797|142909811|SUPERIORITY_OR_OTHER|||||||0.0007|||||||Chi-squared|||Statistical analysis at Last Visit.||||0.0007
71697127|NCT01668797|142909812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.3||||0.0664|TWO_SIDED|95.0|-6.82|0.23|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 6.||0.23|-6.82|0.0664
71697128|NCT01668797|142909812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.31||||0.0301|TWO_SIDED|95.0|-10.1|-0.52|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 12.||-0.52|-10.1|0.0301
71697129|NCT01668797|142909812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.77||||0.0226|TWO_SIDED|95.0|-8.86|-0.68|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 24.||-0.68|-8.86|0.0226
71697130|NCT01668797|142909812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.03||||0.0086|TWO_SIDED|95.0|-10.5|-1.59|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 36.||-1.59|-10.5|0.0086
71697131|NCT01668797|142909812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.31||||0.28|TWO_SIDED|95.0|-18.1|5.46|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 52.||5.46|-18.1|0.2800
71697132|NCT01668797|142909812|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.42||||0.0011|TWO_SIDED|95.0|-7.01|-1.82|||Mixed Models Analysis|||Statistical analysis at across visits||-1.82|-7.01|0.0011
71697133|NCT01668797|142909813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.04||||0.0683|TWO_SIDED|95.0|-6.31|0.23|||ANCOVA|||Statistical analysis at Week 6.||0.23|-6.31|0.0683
71697134|NCT01668797|142909813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.05||||0.0174|TWO_SIDED|95.0|-9.2|-0.9|||ANCOVA|||Statistical analysis at Week 12.||-0.90|-9.20|0.0174
71697135|NCT01668797|142909813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59||||0.0008|TWO_SIDED|95.0|-12.0|-3.18|||ANCOVA|||Statistical analysis at Week 24.||-3.18|-12.0|0.0008
71697136|NCT01668797|142909813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.02||||0.0005|TWO_SIDED|95.0|-12.4|-3.59|||ANCOVA|||Statistical analysis at Week 36.||-3.59|-12.4|0.0005
71697137|NCT01668797|142909813|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.95||||0.0007|TWO_SIDED|95.0|-12.5|-3.41|||ANCOVA|||Statistical analysis at Week 52.||-3.41|-12.5|0.0007
71697138|NCT01668797|142909814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.11||||0.0507|TWO_SIDED|95.0|-2.23|0.0|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.00|-2.23|0.0507
71697139|NCT01668797|142909814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87||||0.008|TWO_SIDED|95.0|-3.24|-0.5|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.50|-3.24|0.0080
71697140|NCT01668797|142909814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.56||||0.0215|TWO_SIDED|95.0|-2.89|-0.24|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.24|-2.89|0.0215
71697141|NCT01668797|142909814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.88||||0.0053|TWO_SIDED|95.0|-3.19|-0.58|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.58|-3.19|0.0053
71697142|NCT01668797|142909814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.71||||0.339|TWO_SIDED|95.0|-5.2|-0.22|||Mixed Models Analysis|||Statistical analysis at Week 52.||-0.22|-5.20|0.339
71697143|NCT01668797|142909814|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|||<|0.0001|TWO_SIDED|95.0|-2.32|-0.88|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.88|-2.32|< 0.0001
71697144|NCT01668797|142909815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.94||||0.1093|TWO_SIDED|95.0|-2.1|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-2.10|0.1093
71697145|NCT01668797|142909815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.86||||0.0089|TWO_SIDED|95.0|-3.25|-0.47|||ANOVA|||Statistical analysis at Week 12.||-0.47|-3.25|0.0089
71697146|NCT01668797|142909815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.74||||0.0005|TWO_SIDED|95.0|-4.26|-1.22|||ANCOVA|||Statistical analysis at Week 24.||-1.22|-4.26|0.0005
71697147|NCT01668797|142909815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.94||||0.0001|TWO_SIDED|95.0|-4.43|-1.44|||ANCOVA|||Statistical analysis at Week 36.||-1.44|-4.43|0.0001
71697148|NCT01668797|142909815|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.18|||<|0.0001|TWO_SIDED|95.0|-4.7|-1.66|||ANCOVA|||Statistical analysis at Week 52||-1.66|-4.70|<0.0001
71697149|NCT01668797|142909816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69||||0.165|TWO_SIDED|95.0|-1.66|0.29|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.29|-1.66|0.1650
71697150|NCT01668797|142909816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.78||||0.2001|TWO_SIDED|95.0|-1.97|0.42|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.42|-1.97|0.2001
71697151|NCT01668797|142909816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.0939|TWO_SIDED|95.0|-2.07|0.16|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.16|-2.07|0.0939
71697152|NCT01668797|142909816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.05||||0.1396|TWO_SIDED|95.0|-2.44|0.35|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.35|-2.44|0.1396
71697153|NCT01668797|142909816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.43||||0.847|TWO_SIDED|95.0|-4.14|5.0|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.00|-4.14|0.8470
71697154|NCT01668797|142909816|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.2258|TWO_SIDED|95.0|-1.24|0.3|||Mixed Models Analysis|||Statistical analysis at across visits.||0.3|-1.24|0.2258
71697155|NCT01668797|142909817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.76||||0.0981|TWO_SIDED|95.0|-1.65|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.65|0.0981
71697156|NCT01668797|142909817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.22||||0.0264|TWO_SIDED|95.0|-2.3|-0.15|||ANCOVA|||Statistical analysis at Week 12.||-0.15|-2.30|0.0264
71697157|NCT01668797|142909817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.55||||0.0078|TWO_SIDED|95.0|-2.69|-0.42|||ANCOVA|||Statistical analysis at Week 24.||-0.42|-2.69|0.0078
71697158|NCT01668797|142909817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.57||||0.0101|TWO_SIDED|95.0|-2.77|-0.38|||ANCOVA|||Statistical analysis at Week 36.||-0.38|-2.77|0.0101
71697159|NCT01668797|142909817|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0516|TWO_SIDED|95.0|-2.5|0.01|||ANCOVA|||Statistical analysis at Week 52||0.01|-2.50|0.0516
71697160|NCT01668797|142909818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28||||0.0279|TWO_SIDED|95.0|-0.53|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.03|-0.53|0.0279
71697161|NCT01668797|142909818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.39||||0.0117|TWO_SIDED|95.0|-0.68|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.09|-0.68|0.0117
71697162|NCT01668797|142909818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37||||0.0105|TWO_SIDED|95.0|-0.64|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.09|-0.64|0.0105
71697163|NCT01668797|142909818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56||||0.0007|TWO_SIDED|95.0|-0.87|-0.25|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.25|-0.87|0.0007
71697164|NCT01668797|142909818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.078|TWO_SIDED|95.0|-1.09|0.06|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.06|-1.09|0.0780
71697165|NCT01668797|142909818|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35||||0.0006|TWO_SIDED|95.0|-0.54|-0.15|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.15|-0.54|0.0006
71697166|NCT01668797|142909819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.0284|TWO_SIDED|95.0|-0.47|-0.03|||ANCOVA|||Statistical analysis at Week 6.||-0.03|-0.47|0.0284
71697167|NCT01668797|142909819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.0056|TWO_SIDED|95.0|-0.62|-0.11|||ANCOVA|||Statistical analysis at Week 12.||-0.11|-0.62|0.0056
71697168|NCT01668797|142909819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.0002|TWO_SIDED|95.0|-0.76|-0.24|||ANCOVA|||Statistical analysis at Week 24.||-0.24|-0.76|0.0002
71697169|NCT01668797|142909819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.56|||<|0.0001|TWO_SIDED|95.0|-0.82|-0.3|||ANCOVA|||Statistical analysis at Week 36.||-0.30|-0.82|<.0001
71697170|NCT01668797|142909819|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.53||||0.0002|TWO_SIDED|95.0|-0.79|-0.26|||ANCOVA|||Statistical analysis at Week 52||-0.26|-0.79|0.0002
71697171|NCT01668797|142909820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.0387|TWO_SIDED|95.0|-0.6|-0.2|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 6.||-0.20|-0.60|0.0387
71697172|NCT01668797|142909820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.41||||0.0185|TWO_SIDED|95.0|-0.75|-0.07|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 12.||-0.07|-0.75|0.0185
71697173|NCT01668797|142909820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61||||0.001|TWO_SIDED|95.0|-0.97|-0.24|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 24.||-0.24|-0.97|0.0010
71697174|NCT01668797|142909820|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0004|TWO_SIDED|95.0|-1.02|-0.3|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 36.||-0.30|-1.02|0.0004
71697175|NCT01668797|142909820|SUPERIORITY_OR_OTHER||Treatment difference|-0.61||||0.0009|TWO_SIDED|95.0|-0.96|-0.25|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 52.||-0.25|-0.96|0.0009
71697176|NCT01668797|142909821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.01||||0.6525|TWO_SIDED|95.0|-3.47|5.49|||Mixed Models Analysis|||Statistical analysis at Week 24.||5.49|-3.47|0.6525
71697177|NCT01668797|142909821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08||||0.1677|TWO_SIDED|95.0|-2.71|14.87|||Mixed Models Analysis|||Statistical analysis at Week 52.||14.87|-2.71|0.1677
71697178|NCT01668797|142909821|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.55||||0.2347|TWO_SIDED|95.0|-2.41|9.5|||Mixed Models Analysis|||Statistical analysis at across visits.||9.5|-2.41|0.2347
71697179|NCT01668797|142909822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.79||||0.0285|TWO_SIDED|95.0|0.4|7.17|||ANCOVA|||Statistical analysis at Week 24.||7.17|0.40|0.0285
71697180|NCT01668797|142909822|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.75||||0.0071|TWO_SIDED|95.0|1.31|8.18|||ANCOVA|||Statistical analysis at Week 52.||8.18|1.31|0.0071
71697181|NCT01668797|142909823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.61||||0.329|TWO_SIDED|95.0|-1.65|4.88|||Mixed Models Analysis|||Statistical analysis at Week 12.||4.88|-1.65|0.3290
71697182|NCT01668797|142909823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.66||||0.1765|TWO_SIDED|95.0|-1.22|6.54|||Mixed Models Analysis|||Statistical analysis at Week 24.||6.54|-1.22|0.1765
71697183|NCT01668797|142909823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.5||||0.0331|TWO_SIDED|95.0|0.38|8.63|||Mixed Models Analysis|||Statistical analysis at Week 36.||8.63|0.38|0.0331
71697184|NCT01668797|142909823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.88||||0.0522|TWO_SIDED|95.0|-0.06|11.82|||Mixed Models Analysis|||Statistical analysis at Week 52.||11.82|-0.06|0.0522
71697185|NCT01668797|142909823|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66||||0.0281|TWO_SIDED|95.0|0.41|6.92|||Mixed Models Analysis|||Statistical analysis at across visits.||6.92|0.41|0.0281
71697186|NCT01668797|142909824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.88||||0.0111|TWO_SIDED|95.0|0.9|6.86|||ANCOVA|||Statistical analysis at Week 12.||6.86|0.90|0.0111
71697187|NCT01668797|142909824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.36||||0.0014|TWO_SIDED|95.0|2.1|8.62|||ANCOVA|||Statistical analysis at Week 24.||8.62|2.10|0.0014
71697188|NCT01668797|142909824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.81|||<|0.0001|TWO_SIDED|95.0|3.61|10.0|||ANCOVA|||Statistical analysis at Week 36.||10.00|3.61|<.0001
71697189|NCT01668797|142909824|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.55||||0.0001|TWO_SIDED|95.0|3.28|9.83|||ANCOVA|||Statistical analysis at Week 52.||9.83|3.28|0.0001
71697190|NCT01668797|142909825|SUPERIORITY_OR_OTHER|||||||0.0014|TWO_SIDED||||||Log Rank|||||||0.0014
71697191|NCT01668797|142909826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.43||||0.1577|TWO_SIDED|95.0|-1.02|0.17|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.17|-1.02|0.1577
71697192|NCT01668797|142909826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1685|TWO_SIDED|95.0|-1.61|0.28|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.28|-1.61|0.1685
71697193|NCT01668797|142909826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.2815|TWO_SIDED|95.0|-1.43|0.42|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.42|-1.43|0.2815
71697194|NCT01668797|142909826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0286|TWO_SIDED|95.0|-2.16|-0.12|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.12|-2.16|0.0286
71697195|NCT01668797|142909826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.03||||0.1803|TWO_SIDED|95.0|-2.58|0.51|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.51|-2.58|0.1803
71697196|NCT01668797|142909826|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.0077|TWO_SIDED|95.0|-1.12|-0.17|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.17|-1.12|0.0077
71697197|NCT01668797|142909827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.1852|TWO_SIDED|95.0|-1.06|0.21|||ANCOVA|||Statistical analysis at Week 6.||0.21|-1.06|0.1852
71697198|NCT01668797|142909827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63||||0.143|TWO_SIDED|95.0|-1.47|0.21|||ANCOVA|||Statistical analysis at Week 12.||0.21|-1.47|0.1430
71697199|NCT01668797|142909827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0323|TWO_SIDED|95.0|-2.06|-0.09|||ANCOVA|||Statistical analysis at Week 24.||-0.09|-2.06|0.0323
71697200|NCT01668797|142909827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0071|TWO_SIDED|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis at Week 36.||-0.37|-2.31|0.0071
71697201|NCT01668797|142909827|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.54||||0.0023|TWO_SIDED|95.0|-2.52|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.52|0.0023
71697202|NCT01668797|142909828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.34||||0.0288|TWO_SIDED|95.0|-2.54|-0.14|||Mixed Models Analysis|||Statistical analysis at Week 6.||-0.14|-2.54|0.0288
71697203|NCT01668797|142909828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.02||||0.0128|TWO_SIDED|95.0|-3.6|-0.44|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.44|-3.60|0.0128
71697204|NCT01668797|142909828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0462|TWO_SIDED|95.0|-3.15|0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.03|-3.15|0.0462
71697205|NCT01668797|142909828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.29||||0.0074|TWO_SIDED|95.0|-3.94|-0.64|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.64|-3.94|0.0074
71697206|NCT01668797|142909828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.4||||0.0136|TWO_SIDED|95.0|-6.05|-0.75|||Mixed Models Analysis|||Statistical analysis at Week 52||-0.75|-6.05|0.0136
71697207|NCT01668797|142909828|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.91||||0.0001|TWO_SIDED|95.0|-2.84|-0.97|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.97|-2.84|0.0001
71697208|NCT01668797|142909829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.08||||0.0695|TWO_SIDED|95.0|-2.26|0.09|||ANCOVA|||Statistical analysis at Week 6.||0.09|-2.26|0.0695
71697209|NCT01668797|142909829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.93||||0.0089|TWO_SIDED|95.0|-3.38|-0.49|||ANCOVA|||Statistical analysis at Week 12.||-0.49|-3.38|0.0089
71697210|NCT01668797|142909829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.83||||0.0004|TWO_SIDED|95.0|-4.39|-1.27|||ANCOVA|||Statistical analysis at Week 24.||-1.27|-4.39|0.0004
71697211|NCT01668797|142909829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.09||||0.0001|TWO_SIDED|95.0|-4.63|-1.54|||ANCOVA|||Statistical analysis at Week 36.||-1.54|-4.63|0.0001
71697212|NCT01668797|142909829|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|||<|0.0001|TWO_SIDED|95.0|-4.99|-1.89|||ANCOVA|||Statistical analysis at Week 52.||-1.89|-4.99|<0.0001
71697213|NCT01668797|142909830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.1969|TWO_SIDED|95.0|-1.66|0.35|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.35|-1.66|0.1969
71697214|NCT01668797|142909830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.8||||0.2007|TWO_SIDED|95.0|-2.04|0.43|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.43|-2.04|0.2007
71697215|NCT01668797|142909830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17||||0.0436|TWO_SIDED|95.0|-2.3|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.03|-2.30|0.0436
71697216|NCT01668797|142909830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.51||||0.0444|TWO_SIDED|95.0|-2.97|-0.04|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.04|-2.97|0.0444
71697217|NCT01668797|142909830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.31||||0.8927|TWO_SIDED|95.0|-4.4|5.02|||Mixed Models Analysis|||Statistical analysis at Week 52.||5.02|-4.40|0.8927
71697218|NCT01668797|142909830|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.52||||0.2154|TWO_SIDED|95.0|-1.34|0.31|||Mixed Models Analysis|||Statistical analysis at across visits.||0.31|-1.34|0.2154
71697219|NCT01668797|142909831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.85||||0.0707|TWO_SIDED|95.0|-1.78|0.07|||ANCOVA|||Statistical analysis at Week 6.||0.07|-1.78|0.0707
71697220|NCT01668797|142909831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.24||||0.0276|TWO_SIDED|95.0|-2.35|-0.14|||ANCOVA|||Statistical analysis at Week 12.||-0.14|-2.35|0.0276
71697221|NCT01668797|142909831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.59||||0.0065|TWO_SIDED|95.0|-2.72|-0.45|||ANCOVA|||Statistical analysis at Week 24.||-0.45|-2.72|0.0065
71697222|NCT01668797|142909831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.0085|TWO_SIDED|95.0|-2.84|-0.42|||ANCOVA|||Statistical analysis at Week 36.||-0.42|-2.84|0.0085
71697223|NCT01668797|142909831|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.23||||0.063|TWO_SIDED|95.0|-2.52|0.07|||ANCOVA|||Statistical analysis at Week 52.||0.07|-2.52|0.0630
71697224|NCT01668797|142909832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.51||||0.2251|TWO_SIDED|95.0|-1.33|0.31|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.31|-1.33|0.2251
71697225|NCT01668797|142909832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13||||0.0368|TWO_SIDED|95.0|-2.19|-0.07|||Mixed Models Analysis|||Statistical analysis at Week 12.||-0.07|-2.19|0.0368
71697226|NCT01668797|142909832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.53||||0.0024|TWO_SIDED|95.0|-2.51|-0.56|||Mixed Models Analysis|||Statistical analysis at Week 24.||-0.56|-2.51|0.0024
71697227|NCT01668797|142909832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.0293|TWO_SIDED|95.0|-2.8|-0.15|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.15|-2.80|0.0293
71697228|NCT01668797|142909832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.9632|TWO_SIDED|95.0|-3.32|3.17|||Mixed Models Analysis|||Statistical analysis at Week 52.||3.17|-3.32|0.9632
71697229|NCT01668797|142909832|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.99||||0.0029|TWO_SIDED|95.0|-1.63|-0.34|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.34|-1.63|0.0029
71697230|NCT01668797|142909833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.65||||0.1062|TWO_SIDED|95.0|-1.44|0.14|||ANCOVA|||Statistical analysis at Week 6.||0.14|-1.44|0.1062
71697231|NCT01668797|142909833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.37||||0.0051|TWO_SIDED|95.0|-2.33|-0.42|||ANCOVA|||Statistical analysis at Week 12.||-0.42|-2.33|0.0051
71697232|NCT01668797|142909833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05||||0.0001|TWO_SIDED|95.0|-3.08|-1.01|||ANCOVA|||Statistical analysis at Week 24.||-1.01|-3.08|0.0001
71697233|NCT01668797|142909833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.94||||0.0004|TWO_SIDED|95.0|-3.0|-0.89|||ANCOVA|||Statistical analysis at Week 36.||-0.89|-3.00|0.0004
71697234|NCT01668797|142909833|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69||||0.0035|TWO_SIDED|95.0|-2.81|-0.56|||ANCOVA|||Statistical analysis at Week 52.||-0.56|-2.81|0.0035
71697235|NCT01668797|142909834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36||||0.1465|TWO_SIDED|95.0|-0.85|0.13|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.13|-0.85|0.1465
71697236|NCT01668797|142909834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49||||0.2154|TWO_SIDED|95.0|-1.27|0.29|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.29|-1.27|0.2154
71697237|NCT01668797|142909834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.44||||0.2696|TWO_SIDED|95.0|-1.23|0.35|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.35|-1.23|0.2696
71697238|NCT01668797|142909834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0179|TWO_SIDED|95.0|-1.95|-0.19|||Mixed Models Analysis|||Statistical analysis at Week 36.||-0.19|-1.95|0.0179
71697239|NCT01668797|142909834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.14||||0.0875|TWO_SIDED|95.0|-2.46|0.18|||Mixed Models Analysis|||Statistical analysis at Week 52.||0.18|-2.46|0.0875
71697240|NCT01668797|142909834|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.66||||0.0021|TWO_SIDED|95.0|-1.08|-0.24|||Mixed Models Analysis|||Statistical analysis at across visits.||-0.24|-1.08|0.0021
71697241|NCT01668797|142909835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.33||||0.2135|TWO_SIDED|95.0|-0.86|0.19|||ANCOVA|||Statistical analysis at Week 6.||0.19|-0.86|0.2135
71697242|NCT01668797|142909835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.42||||0.2437|TWO_SIDED|95.0|-1.13|0.29|||ANCOVA|||Statistical analysis at Week 12.||0.29|-1.13|0.2437
71697243|NCT01668797|142909835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.81||||0.0635|TWO_SIDED|95.0|-1.66|0.05|||ANCOVA|||Statistical analysis at Week 24.||0.05|-1.66|0.0635
71697244|NCT01668797|142909835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.07||||0.0144|TWO_SIDED|95.0|-1.92|-0.22|||ANCOVA|||Statistical analysis at Week 36.||-0.22|-1.92|0.0144
71697245|NCT01668797|142909835|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.26||||0.0046|TWO_SIDED|95.0|-2.12|-0.39|||ANCOVA|||Statistical analysis at Week 52.||-0.39|-2.12|0.0046
71697246|NCT01668797|142909836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47||||0.164|TWO_SIDED|95.0|-1.14|0.19|||Mixed Models Analysis|||Statistical analysis at Week 6.||0.19|-1.14|0.1640
71697247|NCT01668797|142909836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24||||0.5466|TWO_SIDED|95.0|-1.04|0.55|||Mixed Models Analysis|||Statistical analysis at Week 12.||0.55|-1.04|0.5466
71697248|NCT01668797|142909836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.03||||0.9417|TWO_SIDED|95.0|-0.81|0.87|||Mixed Models Analysis|||Statistical analysis at Week 24.||0.87|-0.81|0.9417
71697249|NCT01668797|142909836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.25||||0.6257|TWO_SIDED|95.0|-1.25|0.76|||Mixed Models Analysis|||Statistical analysis at Week 36.||0.76|-1.25|0.6257
71697250|NCT01668797|142909836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.23||||0.7437|TWO_SIDED|95.0|-1.68|1.21|||Mixed Models Analysis|||Statistical analysis at Week 52.||1.21|-1.68|0.7437
71697251|NCT01668797|142909836|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17||||0.4506|TWO_SIDED|95.0|-0.62|0.28|||Mixed Models Analysis|||Statistical analysis at across visits.||0.28|-0.62|0.4506
71697252|NCT01668797|142909837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67||||0.0467|TWO_SIDED|95.0|-1.32|-0.06|||ANCOVA|||Statistical analysis at Week 6.||-0.06|-1.32|0.0467
71697253|NCT01668797|142909837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55||||0.1599|TWO_SIDED|95.0|-1.33|0.22|||ANCOVA|||Statistical analysis at Week 12.||0.22|-1.33|0.1599
71697254|NCT01668797|142909837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.58||||0.1417|TWO_SIDED|95.0|-1.35|0.19|||ANCOVA|||Statistical analysis at Week 24.||0.19|-1.35|0.1417
71697255|NCT01668797|142909837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7||||0.0724|TWO_SIDED|95.0|-1.47|0.06|||ANCOVA|||Statistical analysis at Week 36.||0.06|-1.47|0.0724
71697256|NCT01668797|142909837|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.72||||0.0608|TWO_SIDED|95.0|-1.47|0.03|||ANCOVA|||Statistical analysis at Week 52.||0.03|-1.47|0.0608
71697257|NCT02530385|142909838|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||||||0.16
71697258|NCT02530385|142909839|SUPERIORITY|||||||0.7|||||||Mixed Models Analysis|||||||0.70
71697259|NCT02530385|142909840|SUPERIORITY|||||||0.93|||||||Mixed Models Analysis|||||||0.93
71697260|NCT02530385|142909841|SUPERIORITY|||||||0.9|||||||Mixed Models Analysis|||||||0.90
71697261|NCT02530385|142909842|SUPERIORITY|||||||0.32|||||||Mixed Models Analysis|||||||0.32
71697262|NCT01569022|142909844|EQUIVALENCE|The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71697263|NCT01569022|142909845|EQUIVALENCE|t test assuming unequal variance||||||0.97|||||||t-test, 2 sided|||ESS||||0.97
71697264|NCT01569022|142909845|EQUIVALENCE|t test assuming unequal variance||||||0.98|||||||t-test, 2 sided|||PCL||||0.98
71697265|NCT01569022|142909845|EQUIVALENCE|t-test assuming non unequal variance||||||0.31|||||||t-test, 2 sided|||PSQI||||0.31
71697266|NCT01569022|142909846|EQUIVALENCE|t test assuming unequal variance||||||0.54|||||||t-test, 2 sided|||||||0.54
71697267|NCT01569022|142909847|EQUIVALENCE|t test assuming unequal variance|||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71697268|NCT00433836|142909849|NON_INFERIORITY_OR_EQUIVALENCE|non-inferiority delta of 3.5 mm Hg|Mean Difference (Final Values)|-1.3|||||TWO_SIDED|95.0|-3.8|1.17|||ANOVA|||||1.17|-3.80|
71697269|NCT01026493|142909878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.99||||0.95|TWO_SIDED|95.0|0.66|1.48|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-NAIVE|||1.48|0.66|0.95
71697270|NCT01026493|142909878|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93||||0.93|TWO_SIDED|95.0|0.57|1.53|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-FAILURE|||1.53|0.57|0.93
71697271|NCT02295644|142909887|SUPERIORITY_OR_OTHER|||||||0.17||||||Interaction test of duty cycle and intensity for self reported pain score|ANOVA|||||||0.17
71697272|NCT02295644|142909887|SUPERIORITY_OR_OTHER|||||||0.14||||||Main effect of duty cycle on self reported pain score.|ANOVA|||||||0.14
71697273|NCT02295644|142909887|SUPERIORITY_OR_OTHER|||||||1||||||Main effect of intensity on self reported pain score.|ANOVA|||||||1.0
71697274|NCT02295644|142909888|SUPERIORITY_OR_OTHER|||||||0.24||||||Main effect for duty cycle.|ANOVA|||||||.24
71697275|NCT02295644|142909888|SUPERIORITY_OR_OTHER|||||||0.019||||||Main effect for intensity.|ANOVA|||||||0.019
71697276|NCT02295644|142909888|SUPERIORITY_OR_OTHER|||||||0.17|||||||ANOVA|||Interaction of intensity and duty cycle.||||0.17
71697277|NCT02295644|142909889|SUPERIORITY_OR_OTHER|||||||0.034||||||Main effect for duty cycle.|ANOVA|||||||0.034
71697278|NCT02295644|142909889|SUPERIORITY_OR_OTHER|||||||0.475|||||||ANOVA|||Main effect for intensity.||||0.475
71697279|NCT02295644|142909889|SUPERIORITY_OR_OTHER|||||||0.178|||||||ANOVA|||Interaction of intensity and duty cycle.||||.178
71697280|NCT00324155|142909891|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.179||||0.4067|TWO_SIDED|95.0|0.799|1.74|||Cochran-Mantel-Haenszel|Stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and ECOG performance status (0 vs 1) recorded at randomization.||Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) recorded at randomization.||1.740|0.799|0.4067
71697281|NCT00324155|142909899|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.716||||0.0009|TWO_SIDED|95.0|0.588|0.872||p-value was via stratified log-rank test|Log Rank||Hazard ratio via stratified Cox proportional hazards model.|Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group performance status (0 vs 1) recorded at randomization.||0.872|0.588|0.0009
71697282|NCT03307174|142909903|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71697283|NCT00111761|142909912|SUPERIORITY_OR_OTHER||Percentage of participants|25.0||||||95.0|9.8|46.7||||||||46.7|9.8|
71697284|NCT00111761|142909913|SUPERIORITY_OR_OTHER||Percentage of participants|58.0||||||95.0|34.0|80.0||||||||80|34|
71697285|NCT00111761|142909914|SUPERIORITY_OR_OTHER||Percentage|33.3||||||95.0|15.6|55.3||||||||55.3|15.6|
71697286|NCT00111761|142909919|SUPERIORITY_OR_OTHER||Percentage of participants|47.4||||||95.0|24.4|71.1||||||||71.1|24.4|
71697287|NCT00843492|142909936|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.3|||<|0.001|TWO_SIDED|95.0|0.15|0.54|||Fisher Exact|||||0.54|0.15|<0.001
71697288|NCT00720499|142909968|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.017||0.8937|TWO_SIDED|95.0|-0.035|0.031|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.031|-0.035|0.8937
71697289|NCT00720499|142909969|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.023|STANDARD_ERROR_OF_MEAN|0.019||0.2425|TWO_SIDED|95.0|-0.015|0.061|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.061|-0.015|0.2425
71697290|NCT00720499|142909971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_ERROR_OF_MEAN|0.008||0.5198|TWO_SIDED|95.0|-0.01|0.021|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.021|-0.010|0.5198
71697291|NCT00720499|142909971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.016||0.211|TWO_SIDED|95.0|-0.011|0.051|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.051|-0.011|0.2110
71697292|NCT00720499|142909971|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.001|STANDARD_ERROR_OF_MEAN|0.014||0.9368|TWO_SIDED|95.0|-0.029|0.027|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.027|-0.029|0.9368
71697293|NCT00720499|142909972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.007|STANDARD_ERROR_OF_MEAN|0.01||0.5339|TWO_SIDED|95.0|-0.027|0.014|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.014|-0.027|0.5339
71697294|NCT00720499|142909972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.022|STANDARD_ERROR_OF_MEAN|0.019||0.2408|TWO_SIDED|95.0|-0.015|0.058|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.058|-0.015|0.2408
71697295|NCT00720499|142909972|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.018||0.7139|TWO_SIDED|95.0|-0.029|0.042|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.042|-0.029|0.7139
71697296|NCT00720499|142909973|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.004|STANDARD_ERROR_OF_MEAN|0.015||0.7906|TWO_SIDED|95.0|-0.026|0.034|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.034|-0.026|0.7906
71697297|NCT00720499|142909974|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.007|STANDARD_ERROR_OF_MEAN|0.038||0.8473|TWO_SIDED|95.0|-0.067|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.067|0.8473
71697298|NCT00720499|142909975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.032|STANDARD_ERROR_OF_MEAN|0.031||0.2944|TWO_SIDED|95.0|-0.029|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.029|0.2944
71697299|NCT00720499|142909975|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.028||0.718|TWO_SIDED|95.0|-0.046|0.066|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.066|-0.046|0.7180
71697300|NCT00720499|142909977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.001|STANDARD_ERROR_OF_MEAN|0.015||0.9384|TWO_SIDED|95.0|-0.029|0.032|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)||0.032|-0.029|0.9384
71697301|NCT00720499|142909977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_ERROR_OF_MEAN|0.026||0.1583|TWO_SIDED|95.0|-0.014|0.088|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.088|-0.014|0.1583
71697302|NCT00720499|142909977|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.029|STANDARD_ERROR_OF_MEAN|0.027||0.2914|TWO_SIDED|95.0|-0.025|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.082|-0.025|0.2914
71697303|NCT00720499|142909978|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.035|STANDARD_ERROR_OF_MEAN|0.03||0.2485|TWO_SIDED|95.0|-0.024|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.094|-0.024|0.2485
71697304|NCT00720499|142909979|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.046|STANDARD_ERROR_OF_MEAN|0.043||0.2875|TWO_SIDED|95.0|-0.039|0.13|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.130|-0.039|0.2875
71697305|NCT00720499|142909980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.984|STANDARD_ERROR_OF_MEAN|2.038||0.6299|TWO_SIDED|95.0|-3.046|5.015|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.015|-3.046|0.6299
71697306|NCT00720499|142909980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.311|STANDARD_ERROR_OF_MEAN|3.156||0.0475|TWO_SIDED|95.0|0.07|12.553|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||12.553|0.070|0.0475
71697307|NCT00720499|142909980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.552|STANDARD_ERROR_OF_MEAN|2.67||0.562|TWO_SIDED|95.0|-3.729|6.833|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.833|-3.729|0.5620
71697308|NCT00720499|142909981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.179|STANDARD_ERROR_OF_MEAN|2.342||0.9391|TWO_SIDED|95.0|-4.812|4.454|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||4.454|-4.812|0.9391
71697309|NCT00720499|142909981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.48|STANDARD_ERROR_OF_MEAN|3.559||0.0709|TWO_SIDED|95.0|-0.56|13.52|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||13.520|-0.560|0.0709
71697310|NCT00720499|142909981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.099|STANDARD_ERROR_OF_MEAN|3.134||0.3245|TWO_SIDED|95.0|-3.1|9.298|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||9.298|-3.100|0.3245
71697311|NCT00720499|142909982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.7|STANDARD_ERROR_OF_MEAN|4.655||0.8808|TWO_SIDED|95.0|-9.914|8.514|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.514|-9.914|0.8808
71697312|NCT00720499|142909983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.119|STANDARD_ERROR_OF_MEAN|2.177||0.6081|TWO_SIDED|95.0|-3.19|5.429|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.429|-3.190|0.6081
71697313|NCT00720499|142909983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.339|STANDARD_ERROR_OF_MEAN|2.342||0.5686|TWO_SIDED|95.0|-3.296|5.973|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.973|-3.296|0.5686
71697314|NCT00720499|142909983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.653|STANDARD_ERROR_OF_MEAN|2.294||0.7765|TWO_SIDED|95.0|-3.888|5.194|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||5.194|-3.888|0.7765
71697315|NCT00720499|142909983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.654|STANDARD_ERROR_OF_MEAN|2.543||0.5166|TWO_SIDED|95.0|-3.379|6.686|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.686|-3.379|0.5166
71697316|NCT00720499|142909984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.303|STANDARD_ERROR_OF_MEAN|2.585||0.2037|TWO_SIDED|95.0|-1.813|8.418|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||8.418|-1.813|0.2037
71697317|NCT00720499|142909984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.393|STANDARD_ERROR_OF_MEAN|2.738||0.6118|TWO_SIDED|95.0|-4.027|6.813|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.813|-4.027|0.6118
71697318|NCT00720499|142909984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.695|STANDARD_ERROR_OF_MEAN|2.498||0.4988|TWO_SIDED|95.0|-3.251|6.64|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||6.640|-3.251|0.4988
71697319|NCT00720499|142909984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.039|STANDARD_ERROR_OF_MEAN|2.478||0.6757|TWO_SIDED|95.0|-5.944|3.865|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||3.865|-5.944|0.6757
71697320|NCT00720499|142909985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.011|STANDARD_ERROR_OF_MEAN|0.08||0.8901|TWO_SIDED|95.0|-0.147|0.169|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.169|-0.147|0.8901
71697321|NCT00720499|142909985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12|STANDARD_ERROR_OF_MEAN|0.086||0.1647|TWO_SIDED|95.0|-0.29|0.05|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.050|-0.290|0.1647
71697322|NCT00720499|142909985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.002|STANDARD_ERROR_OF_MEAN|0.09||0.9822|TWO_SIDED|95.0|-0.18|0.176|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.176|-0.180|0.9822
71697323|NCT00720499|142909985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04|STANDARD_ERROR_OF_MEAN|0.09||0.6542|TWO_SIDED|95.0|-0.218|0.137|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.137|-0.218|0.6542
71697324|NCT00720499|142909986|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.114|STANDARD_ERROR_OF_MEAN|0.116||0.3269|TWO_SIDED|95.0|-0.342|0.115|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for treatment, centre, patient within centre and period (all effects fixed).||0.115|-0.342|0.3269
71697325|NCT00720499|142909987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.005|STANDARD_ERROR_OF_MEAN|0.089||0.9557|TWO_SIDED|95.0|-0.181|0.171|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.171|-0.181|0.9557
71697326|NCT00720499|142909987|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.019|STANDARD_ERROR_OF_MEAN|0.08||0.8096|TWO_SIDED|95.0|-0.178|0.14|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).||0.140|-0.178|0.8096
71697327|NCT02941640|142910041|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05|ANOVA|||||||<0.0001
71697328|NCT02941640|142910041|OTHER|||||||0.001||||||Significant when P\<0.05.|Tukey post hoc test|||Post hoc analysis was done by Tukey test.||||0.001
71697329|NCT02941640|142910041|OTHER|Tukey post hoc test|||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
71697330|NCT02941640|142910041|OTHER|||||||0.044||||||Significant when P\<0.05|Tukey post hoc test|||||||0.044
71697331|NCT02941640|142910041|OTHER||||||<|0.272||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.272
71697332|NCT02941640|142910041|OTHER|||||||0.835||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.835
71697333|NCT02941640|142910041|OTHER|||||||0.199||||||Significant when P\<0.05.|Tukey post hoc test|||||||0.199
71697334|NCT02941640|142910042|OTHER|Anova|||||<|0.0001||||||Significant when P\<0.05.|ANOVA|||||||<0.0001
71697335|NCT02941640|142910042|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
71697336|NCT02941640|142910042|OTHER||||||<|0.0001||||||Significant when P\<0.05|Tukey post hoc test|||||||<0.0001
71697337|NCT02941640|142910042|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
71697338|NCT02941640|142910042|OTHER||||||<|0.0001|||||||Tukey post hoc test|||||||<0.0001
71697339|NCT02941640|142910042|OTHER||||||<|0.0001||||||Significant when P\<0.05.|Tukey post hoc test|||||||<0.0001
71697340|NCT02941640|142910042|OTHER|||||||1||||||Significant when P\<0.05|Tukey post hoc test|||||||1.00
71697341|NCT04030598|142910050|SUPERIORITY||Percentage Difference|-90.0||||0.001|TWO_SIDED|95.0|-96.0|-76.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100 percentage (%) × (mean rate ratio -1).|||-76.00|-96.00|0.001
71697342|NCT04030598|142910051|SUPERIORITY||Percentage Difference|-89.0||||0.003|TWO_SIDED|95.0|-95.0|-77.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-77.00|-95.00|0.003
71697343|NCT04030598|142910052|SUPERIORITY||Percentage Difference|-96.0||||0.004|TWO_SIDED|95.0|-100.0|-65.0|||Wald Chi-Square||The percentage difference in mean investigator-confirmed HAE attack rate between donidalorsen 80 mg and placebo was calculated as 100% × (mean rate ratio -1).|||-65.00|-100.00|0.004
71697344|NCT04030598|142910053|SUPERIORITY||Risk Difference (RD)|66.7||||0.004|TWO_SIDED|95.0|17.5|95.7|||Fisher Exact|||For ≥ 50% reduction from Baseline in the HAE attack rate.||95.7|17.5|0.004
71697345|NCT04030598|142910053|SUPERIORITY||Risk Difference (RD)|75.6||||0.003|TWO_SIDED|95.0|26.8|96.5|||Fisher Exact|||For ≥ 70% reduction from Baseline in the HAE attack rate.||96.5|26.8|0.003
71697346|NCT04030598|142910053|SUPERIORITY||Risk Difference (RD)|92.3|||<|0.001|TWO_SIDED|95.0|48.0|99.8|||Fisher Exact|||For ≥ 90% reduction from Baseline in the HAE attack rate.||99.8|48.0|<0.001
71697347|NCT04030598|142910054|SUPERIORITY||Percentage Difference|-95.0||||0.009|TWO_SIDED|95.0|-99.0|-52.0|||Wald Chi-Square|||||-52.00|-99.00|0.009
71697348|NCT04030598|142910057|SUPERIORITY||Risk Difference (RD)|-14.3||||1|TWO_SIDED|95.0|-59.1|33.9|||Fisher Exact|||Week 9||33.9|-59.1|1.000
71697349|NCT04030598|142910057|SUPERIORITY||Risk Difference (RD)|-21.4||||0.521|TWO_SIDED|95.0|-64.9|27.1|||Fisher Exact|||Week 17||27.1|-64.9|0.521
71697350|NCT04030598|142910058|SUPERIORITY||Treatment Difference|-25.92|||||TWO_SIDED|95.0|-37.1|-14.74||||||Week 9||-14.74|-37.10|
71697351|NCT04030598|142910058|SUPERIORITY||Treatment Difference|-20.69|||||TWO_SIDED|95.0|-32.7|-8.68||||||Week 17||-8.68|-32.70|
71697352|NCT05079321|142910059|OTHER|||||||0.25|||||||t-test, 2 sided|||||||0.25
71697353|NCT05079321|142910060|OTHER|||||||0.36|||||||t-test, 2 sided|||||||0.36
71697354|NCT05079321|142910061|OTHER|||||||1|||||||t-test, 2 sided|||||||1.0
71697355|NCT05079321|142910062|OTHER|||||||0.06|||||||t-test, 2 sided|||||||0.06
71697356|NCT05079321|142910063|OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
71697357|NCT05079321|142910064|OTHER|||||||0.07|||||||t-test, 2 sided|||||||0.07
71697358|NCT05079321|142910065|OTHER|||||||0.33|||||||t-test, 2 sided|||||||0.33
71697359|NCT05079321|142910066|OTHER|||||||0.65|||||||t-test, 2 sided|||||||0.65
71697360|NCT05079321|142910068|OTHER|||||||0.91|||||||t-test, 2 sided|||||||0.91
71697361|NCT05079321|142910069|OTHER|||||||0.71|||||||t-test, 2 sided|||||||0.71
71697362|NCT05079321|142910070|OTHER|||||||0.97|||||||t-test, 2 sided|||||||0.97
71697363|NCT05079321|142910071|OTHER|||||||0.75|||||||Fisher Exact|||||||0.75
71697364|NCT05079321|142910072|OTHER|||||||0.59|||||||Fisher Exact|||||||0.59
71697365|NCT05079321|142910073|OTHER|||||||0.69|||||||Fisher Exact|||||||0.69
71697366|NCT00032591|142910105|NON_INFERIORITY_OR_EQUIVALENCE|A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years.|Hazard Ratio (HR)|0.88||||0.14|||||||Log Rank|||The null hypothesis was the hazard ratio was equal to 1.||||0.14
71697367|NCT02873689|142910110|SUPERIORITY|||||||0.057|||||||Wilcoxon rank-sum test|||||||0.057
71697368|NCT02873689|142910111|SUPERIORITY|||||||0.268|||||||Wilcoxon rank-sum test|||||||0.268
71697369|NCT02997163|142910135|SUPERIORITY||Percent Ratio of Geometric Means|112.2|||||TWO_SIDED|90.0|80.06|157.26||||||||157.26|80.06|
71697370|NCT02997163|142910135|SUPERIORITY||Percent Ratio of Geometric Means|142.98|||||TWO_SIDED|90.0|103.03|198.42||||||||198.42|103.03|
71697371|NCT02997163|142910135|SUPERIORITY||Percent Ratio of Geometric Means|263.32|||||TWO_SIDED|90.0|187.88|369.06||||||||369.06|187.88|
71697372|NCT02997163|142910136|SUPERIORITY||Percent Ratio of Geometric Means|111.13|||||TWO_SIDED|90.0|74.4|166.01||||||||166.01|74.40|
71697373|NCT02997163|142910136|SUPERIORITY||Percent Ratio of Geometric Means|131.57|||||TWO_SIDED|90.0|89.12|194.25||||||||194.25|89.12|
71697374|NCT02997163|142910136|SUPERIORITY||Percent Ratio of Geometric Means|189.32|||||TWO_SIDED|90.0|126.74|282.8||||||||282.80|126.74|
71697375|NCT02997163|142910137|SUPERIORITY||Percent Ratio of Geometric Means|118.58|||||TWO_SIDED|90.0|83.85|167.7||||||||167.70|83.85|
71697376|NCT02997163|142910137|SUPERIORITY||Percent Ratio of Geometric Means|139.34|||||TWO_SIDED|90.0|99.53|195.06||||||||195.06|99.53|
71697377|NCT02997163|142910137|SUPERIORITY||Percent Ratio of Geometric Means|286.61|||||TWO_SIDED|90.0|202.66|405.33||||||||405.33|202.66|
71697378|NCT02997163|142910138|SUPERIORITY||Percent Ratio of Geometric Means|117.45|||||TWO_SIDED|90.0|79.74|172.99||||||||172.99|79.74|
71697379|NCT02997163|142910138|SUPERIORITY||Percent Ratio of Geometric Means|128.22|||||TWO_SIDED|90.0|88.05|186.72||||||||186.72|88.05|
71697380|NCT02997163|142910138|SUPERIORITY||Percent Ratio of Geometric Means|206.07|||||TWO_SIDED|90.0|139.91|303.51||||||||303.51|139.91|
71697381|NCT02470741|142910174|SUPERIORITY||Mean Difference (Net)|-11.85||||0.24|TWO_SIDED|95.0|-32.92|9.23|||Mixed Models Analysis|Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|Null hypotheses: Letrozole is not associated with an improvement in the UFSQOL Overall Score.||9.23|-32.92|0.24
71697382|NCT00485836|142910175|SUPERIORITY_OR_OTHER||Difference in Least Squares means|11.5|||<|0.0001||95.0|7.7|15.3||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||15.3|7.7|<0.0001
71697383|NCT00485836|142910175|SUPERIORITY_OR_OTHER||Difference in Least Squares means|13.8|||<|0.0001||95.0|10.3|17.4||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).||||17.4|10.3|<0.0001
71697384|NCT00485836|142910176|SUPERIORITY_OR_OTHER||Difference in percentage|29.3|||<|0.0001||95.0|18.8|39.7|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||39.7|18.8|<0.0001
71697385|NCT00485836|142910176|SUPERIORITY_OR_OTHER||Difference in percentage|30.3|||<|0.0001||95.0|19.6|40.9|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||40.9|19.6|<0.0001
71697386|NCT00485836|142910177|SUPERIORITY_OR_OTHER||Difference in percentage|11.3||||0.0019||95.0|4.3|18.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||18.2|4.3|0.0019
71697387|NCT00485836|142910177|SUPERIORITY_OR_OTHER||Difference in percentage|13.6|||<|0.0001||95.0|7.2|20.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||20.1|7.2|<0.0001
71697388|NCT00485836|142910178|SUPERIORITY_OR_OTHER||Difference in percentage|51.9|||<|0.0001||95.0|41.6|62.3|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||62.3|41.6|<0.0001
71697389|NCT00485836|142910178|SUPERIORITY_OR_OTHER||Difference in percentage|54.0|||<|0.0001||95.0|44.0|64.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.|||64.1|44.0|<0.0001
71697390|NCT00485836|142910179|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-272.2|||<|0.0001||95.0|-329.9|-214.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-214.5|-329.9|<0.0001
71697391|NCT00485836|142910179|SUPERIORITY_OR_OTHER||Difference in Least Squares means|-283.8|||<|0.0001||95.0|-337.8|-229.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.||||-229.8|-337.8|<0.0001
71697392|NCT00485836|142910180|SUPERIORITY_OR_OTHER||Difference in Least Squares means|5.8||||0.0019||95.0|2.1|9.4|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||9.4|2.1|0.0019
71697393|NCT00485836|142910180|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.9||||0.0099||95.0|1.2|8.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.||||8.6|1.2|0.0099
71697394|NCT00485836|142910181|SUPERIORITY_OR_OTHER||Difference in Least Squares means|6.3||||0.0002||95.0|3.1|9.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||9.5|3.1|0.0002
71697395|NCT00485836|142910181|SUPERIORITY_OR_OTHER||Difference in Least Squares means|4.1||||0.0199||95.0|0.7|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.||||7.6|0.7|0.0199
71697396|NCT01949545|142910193|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|144.43||||0.02232|TWO_SIDED|95.0|111.48|187.12|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an analysis of variance (ANOVA) of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||187.12|111.48|0.02232
71697397|NCT01949545|142910193|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|126.08||||0.1812|TWO_SIDED|95.0|94.59|168.06|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||168.06|94.59|0.1812
71761205|NCT00611026|143024041|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0200
71761229|NCT00611026|143024045|SUPERIORITY_OR_OTHER|||||||0.0828|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0828
71697398|NCT01949545|142910194|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|151.84||||0.02137|TWO_SIDED|95.0|113.59|202.96|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||202.96|113.59|0.02137
71697399|NCT01949545|142910194|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|143.53||||0.07247|TWO_SIDED|95.0|103.28|199.45|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.||199.45|103.28|0.07247
71697400|NCT01677286|142910249|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|171.0||||0.035|TWO_SIDED|95.0|14.1|328.0|||Mixed Models Analysis|degrees of freedom = 12||BNP pg/mL, baseline versus end study values||328|14.1|0.035
71697401|NCT01677286|142910250|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|0.0072||||0.34|TWO_SIDED|95.0|-0.009|0.0234|||Mixed Models Analysis|degrees of freedom = 12||Troponin I ng/mL, baseline versus end study levels.||0.0234|-0.009|0.340
71697402|NCT01677286|142910251|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|-7.39||||0.017|TWO_SIDED|95.0|-13.12|-1.67|||Mixed Models Analysis|degrees of freedom = 10||Creatinine clearance, baseline versus end study levels.||-1.67|-13.12|0.017
71697403|NCT01677286|142910252|OTHER|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|0.091||||0.603|TWO_SIDED|95.0|-0.285|0.466|||Mixed Models Analysis|degrees of freedom = 10||Proteinuria (g/24 hours), baseline versus end study levels.||0.466|-0.285|0.603
71761206|NCT00611026|143024042|SUPERIORITY_OR_OTHER|||||||0.0006|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0006
71761207|NCT00611026|143024042|SUPERIORITY_OR_OTHER|||||||0.0202|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0202
71761208|NCT00611026|143024042|SUPERIORITY_OR_OTHER|||||||0.2126|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.2126
71761209|NCT00611026|143024042|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71761210|NCT00611026|143024042|SUPERIORITY_OR_OTHER|||||||0.0019|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0019
71761211|NCT00611026|143024042|SUPERIORITY_OR_OTHER|||||||0.0148|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0148
71697404|NCT01258374|142910253|OTHER||||||<|0.01||||||The PK paramaters reported as geometric means, were calculated using noncompartmental modelinf techniques (WinNolin; Pharsight Corporation, Mountain View, CA)|Noncompartmental modeling techniques||||The pharmacokinetic parameters calculated for DRV, RTV and RAL were trough plasma concentration (C trough), defined as the concentration at 24 or 12 h after observed dose, the maximum observed plasma concentration (C max), the area under the plasma concentration-time curve from 0 to 24 H (AUC 0-24) or 0 to 12 h (AUC 0-12) and the elimination half-life (t1/2). AUC and t1/2 were calculated using non using noncompartmental modeling techniques (WinNolin; Pharsight Corporation, Mountain View, CA). All of these PK parameters are reported as geometric means.|||<0.01
71697405|NCT01663623|142910274|OTHER||Hazard Ratio (HR)|1.07||||0.884|TWO_SIDED|95.0|0.44|2.59||Cox proportional Hazards (Wald Chi Square)|Cox Proportional Hazards model|Analysis was adjusted for ANCA type, disease stage at induction and induction regimen|Analysis performed using a Cox Proportional Hazards model with covariates treatment group, Actual ANCA type, Actual disease stage at induction and Actual induction regimen.|||2.59|0.44|0.884
71697406|NCT02265510|142910290|OTHER|Descriptive Statistics|||||||||||||||||The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697407|NCT02265510|142910291|OTHER||||||||||||||||||Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
71697408|NCT02265510|142910292|OTHER||||||||||||||||||Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.|||
71697409|NCT02265510|142910293|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697410|NCT02265510|142910294|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697411|NCT02265510|142910295|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697412|NCT02265510|142910296|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697413|NCT02265510|142910297|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697414|NCT02265510|142910298|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697415|NCT02265510|142910299|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71697416|NCT02265510|142910300|OTHER||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.|||
71758606|NCT00836693|143019585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.2|STANDARD_ERROR_OF_MEAN|3.36|<|0.001|TWO_SIDED|95.0|6.6|19.8||p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||19.8|6.6|<0.001
71697417|NCT01004614|142910313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|98.61|||||TWO_SIDED|90.0|93.09|104.46|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||104.46|93.09|
71761212|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0012|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.||||0.0012
71697418|NCT01004614|142910313|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|101.29|||||TWO_SIDED|90.0|97.28|105.45|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||105.45|97.28|
71697419|NCT01004614|142910314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|99.3|||||TWO_SIDED|90.0|92.28|106.28||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.28|92.28|
71761213|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0205|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 1.||||0.0205
71761214|NCT00611026|143024043|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.||||<0.0001
71761215|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0038|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.||||0.0038
71697420|NCT01004614|142910314|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|100.84|||||TWO_SIDED|90.0|95.93|106.0||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL \<=µT - µR \<=θU); null hypothesis of inequivalence: (Ho: µT - µR \<θL or µT - µR \>θU).||106.00|95.93|
71697421|NCT02111083|142910320|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.965|1.01||||||||1.01|0.965|
71697422|NCT02111083|142910321|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.872|||||TWO_SIDED|90.0|0.828|0.919||||||||0.919|0.828|
71697423|NCT02111083|142910322|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.25|||||TWO_SIDED|90.0|0.0|0.375||||||||0.375|0|
71697424|NCT02111083|142910323|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.986|||||TWO_SIDED|90.0|0.954|1.02||||||||1.02|0.954|
71697425|NCT02111083|142910324|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.95|||||TWO_SIDED|90.0|0.901|1.0||||||||1.00|0.901|
71697426|NCT02111083|142910325|SUPERIORITY_OR_OTHER||Difference of least squares means|0.424|||||TWO_SIDED|90.0|0.164|0.685||||||||0.685|0.164|
71697427|NCT02111083|142910326|SUPERIORITY_OR_OTHER||Ratio of geometric least square means|0.992|||||TWO_SIDED|90.0|0.975|1.01||||||||1.01|0.975|
71697428|NCT00486044|142910331|SUPERIORITY_OR_OTHER|||||||0.966||95.0|||||Kruskal-Wallis|||||||0.966
71697429|NCT00486044|142910332|SUPERIORITY_OR_OTHER|||||||0.015||95.0|||||ANCOVA|||||||0.015
71697430|NCT00486044|142910333|SUPERIORITY_OR_OTHER|||||||0.113||95.0|||||Kruskal-Wallis|||||||0.113
71697431|NCT00486044|142910334|SUPERIORITY_OR_OTHER|||||||0.21||95.0|||||Kruskal-Wallis|||||||0.210
71697432|NCT02449434|142910336|OTHER|Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).|Odds Ratio (OR)|2.25|||<|0.05|TWO_SIDED|95.0||||Only results from fully adjusted regression models will be deemed as significant|Regression, Logistic|Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals||A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.||||<0.05
71697433|NCT03154086|142910433|OTHER||Ratio|0.8||||0.204|TWO_SIDED|90.0|0.594|1.077|||ANOVA|||||1.077|0.5940|0.204
71697434|NCT03154086|142910434|OTHER||Ratio|0.7325||||0.118|TWO_SIDED|90.0|0.5267|1.019|||ANOVA|||||1.019|0.5267|0.118
71697435|NCT03154086|142910435|OTHER||Ratio|0.6502||||0.157|TWO_SIDED|90.0|0.3876|1.091|||ANOVA|||||1.091|0.3876|0.157
71697436|NCT00966433|142910456|OTHER||Mean Difference (Final Values)|-8.2||||0.0051|TWO_SIDED|95.0|-13.61|-2.79|||t-test, 2 sided|||||-2.79|-13.61|.0051
71697437|NCT00966433|142910457|OTHER||Mean Difference (Final Values)|3.6||||0.0001|TWO_SIDED|95.0|2.97|4.23|||t-test, 2 sided|||||4.23|2.97|.0001
71697438|NCT00966433|142910462|OTHER||Mean Difference (Final Values)|-13.9||||0.0001|TWO_SIDED|95.0|-18.88|-8.92|||t-test, 2 sided|||||-8.92|-18.88|.0001
71697439|NCT00461734|142910494|SUPERIORITY_OR_OTHER|||||||0.4347|||||||two-sided z-test|||||||0.4347
71697440|NCT00461734|142910495|SUPERIORITY_OR_OTHER|||||||0.338|||||||two-sided z-test|||||||0.338
71697441|NCT00461734|142910496|SUPERIORITY_OR_OTHER|||||||0.2257|||||||Wilcoxon (Mann-Whitney)|||||||0.2257
71697442|NCT00461734|142910497|SUPERIORITY_OR_OTHER|||||||0.548|||||||Wilcoxon (Mann-Whitney)|||||||0.5480
71697443|NCT00461734|142910498|SUPERIORITY_OR_OTHER|||||||0.8868|||||||Wilcoxon (Mann-Whitney)|||||||0.8868
71697444|NCT00461734|142910499|SUPERIORITY_OR_OTHER|||||||0.6151|||||||Wilcoxon (Mann-Whitney)|||||||0.6151
71697445|NCT00461734|142910503|SUPERIORITY_OR_OTHER|||||||0.0525|||||||t-test, 2 sided|||||||0.0525
71697446|NCT00461734|142910504|SUPERIORITY_OR_OTHER|||||||0.1852|||||||t-test, 2 sided|||||||0.1852
71697447|NCT00461734|142910506|SUPERIORITY_OR_OTHER|||||||0.9719|||||||Wilcoxon (Mann-Whitney)|||||||0.9719
71697448|NCT00461734|142910507|SUPERIORITY_OR_OTHER|||||||0.8779|||||||Wilcoxon (Mann-Whitney)|||||||0.8779
71697449|NCT02139540|142910523|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)||||<0.05
71697450|NCT02139540|142910524|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71697451|NCT01621009|142910533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.61|||>|0.05|TWO_SIDED|95.0|0.78|3.36|||Regression, Logistic|||||3.36|.78|>0.05
71697452|NCT01621009|142910533|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.13|||>|0.05|TWO_SIDED|95.0|0.52|2.44|||Regression, Logistic|||||2.44|.52|>0.05
71697453|NCT02717195|142910552|SUPERIORITY||Mean Difference (Final Values)|-0.12||||0.9196|TWO_SIDED|95.0|-2.37|2.13||Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.13|-2.37|0.9196
71697454|NCT02717195|142910552|SUPERIORITY||Mean Difference (Final Values)|1.67||||0.1474|TWO_SIDED|95.0|-0.59|3.94||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||3.94|-0.59|0.1474
71697455|NCT02717195|142910553|SUPERIORITY||Mean Difference (Final Values)|0.96||||0.2998|TWO_SIDED|95.0|-0.86|2.78||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||2.78|-0.86|0.2998
71697456|NCT02717195|142910553|SUPERIORITY||Mean Difference (Final Values)|-0.71||||0.4478|TWO_SIDED|95.0|-2.54|1.12||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values\>0.05.|Mixed model repeated measures|||The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.||1.12|-2.54|0.4478
71697457|NCT00855218|142910560|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.797||||0.072||95.0|0.588|1.08||stratified one-sided (alpha=0.15). adjusted for region and Alfa-fetoprotein (AFP) level at baseline.|Log Rank|||||1.080|0.588|0.072
71697458|NCT00855218|142910561|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.898||||0.295||95.0|0.606|1.33|||Log Rank|stratified one-sided (alpha=0.15). adjusted for region and AFP level at baseline.||||1.330|0.606|0.295
71697459|NCT00855218|142910562|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.586||||0.999||95.0|1.2|2.096|||Log Rank|startified one-sided (alpha=0.15), adjusted for region and AFP level at baseline||||2.096|1.200|0.999
71697460|NCT00855218|142910563|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.621||||0.076||95.0|0.321|1.2|||Log Rank|stratified one sided (alpha=0.15), adjusted on region and AFP level at baseline||||1.200|0.321|0.076
71697461|NCT03191552|142910575|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71697462|NCT03191552|142910576|SUPERIORITY|||||||0.027||||||Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.027
71697463|NCT03191552|142910577|SUPERIORITY|||||||0.008||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.008
71697464|NCT03191552|142910578|SUPERIORITY|Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.||||||0.004||||||Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0.004
71697465|NCT03191552|142910579|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||||||0.837
71697466|NCT03191552|142910580|SUPERIORITY|||||||0.57|||||||Kruskal-Wallis|||||||0.570
71697467|NCT03191552|142910581|SUPERIORITY|||||||0.334|||||||Kruskal-Wallis|||||||0.334
71697468|NCT03191552|142910582|SUPERIORITY|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||||||0.001
71697469|NCT03191552|142910583|SUPERIORITY|||||||0.77|||||||Kruskal-Wallis|||||||0.77
71697470|NCT03191552|142910584|SUPERIORITY|||||||0.889|||||||Kruskal-Wallis|||||||0.889
71697471|NCT03191552|142910585|SUPERIORITY|||||||0.956|||||||Kruskal-Wallis|||||||0.956
71697472|NCT03191552|142910586|SUPERIORITY||||||,|0||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis|||||||0,001
71697473|NCT03191552|142910587|SUPERIORITY|||||||0.14|||||||Kruskal-Wallis|||||||0.14
71697474|NCT03191552|142910588|SUPERIORITY|||||||0.08|||||||Kruskal-Wallis|||||||0.08
71697475|NCT03191552|142910589|SUPERIORITY|||||||0.314|||||||Wilcoxon (Mann-Whitney)|||||||0.314
71697476|NCT03191552|142910590|SUPERIORITY|||||||0.244|||||||Wilcoxon (Mann-Whitney)|||||||0.244
71697477|NCT03191552|142910591|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.27
71697478|NCT01149655|142910592|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.461||||0.0161|TWO_SIDED|95.0|0.242|0.879|||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.|Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio \< 1 is in favor of oral aripiprazole 10-30 mg group for superiority test.|The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||0.879|0.242|0.0161
71697479|NCT01149655|142910594|SUPERIORITY_OR_OTHER|||||||0.0962|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0962
71697480|NCT01149655|142910595|SUPERIORITY_OR_OTHER|||||||0.9025|TWO_SIDED||||||Chi-squared|p-value was derived using Chi-square test.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9025
71697481|NCT01149655|142910596|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Log Rank|p-value was derived from the log-rank tests.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
71697482|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.3862|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis at Baseline. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3862
71697483|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.8861|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 1. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8861
71697484|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.8189|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 2. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.8189
71697485|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.3689|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 3. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.3689
71697486|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.9723|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 4. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.9723
71697487|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.2985|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 6. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.2985
71697488|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0883|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 8. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0883
71697489|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 10. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0228
71697490|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0274|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 12. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0274
71697491|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0135|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 14. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0135
71697492|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0059|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 16. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0059
71697493|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0076|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 18. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0076
71697494|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0065|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 20. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0065
71697495|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0175|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 22. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0175
71697496|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0107|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 24. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0107
71697497|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0118|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 26. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0118
71697498|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0232|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 28. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0232
71697499|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0337|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 30. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0337
71697500|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0507|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 32. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0507
71697501|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0791|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 34. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0791
71697502|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0898|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 36. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0898
71697503|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 38. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
71697504|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0833|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 40. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0833
71697505|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0824|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 42. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0824
71697506|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0686|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 44. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0686
71697507|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0737|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 46. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0737
71697508|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0893|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 48. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0893
71697509|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0706|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 50. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0706
71697510|NCT01149655|142910599|SUPERIORITY_OR_OTHER|||||||0.0657|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 52. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).||||0.0657
71697511|NCT01265498|142910603|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.9||||0.0002|TWO_SIDED|95.0|1.3|2.8|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status.|obeticholic acid vs placebo|||2.8|1.3|0.0002
71697512|NCT01265498|142910604|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.08|TWO_SIDED|95.0|0.9|2.6|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.6|0.9|0.08
71697513|NCT01265498|142910605|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.8||||0.004|TWO_SIDED|95.0|1.1|2.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.7|1.1|0.004
71697514|NCT01265498|142910606|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.01|TWO_SIDED|95.0|-0.6|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.6|0.01
71697515|NCT01265498|142910607|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-1.3|<0.0001
71697516|NCT01265498|142910608|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.5||||0.03|TWO_SIDED|95.0|1.0|2.1|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo|||2.1|1.0|0.03
71697517|NCT01265498|142910609|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.03|TWO_SIDED|95.0|-0.5|0.0|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.0|-0.5|0.03
71697518|NCT01265498|142910610|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.7||||0.001|TWO_SIDED|95.0|1.2|2.3|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.3|1.2|0.001
71697519|NCT01265498|142910611|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.0004|TWO_SIDED|95.0|-0.6|-0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-0.6|0.0004
71697520|NCT01265498|142910612|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.6||||0.006|TWO_SIDED|95.0|1.1|2.2|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||2.2|1.1|0.006
71697521|NCT01265498|142910613|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.3||||0.0006|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-0.5|0.0006
71697522|NCT01265498|142910614|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.0||||0.9|TWO_SIDED|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo|||1.7|0.6|0.90
71697523|NCT01265498|142910615|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.59|TWO_SIDED|95.0|-0.1|0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-0.1|0.59
71697524|NCT01265498|142910616|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-20.0|||<|0.0001|TWO_SIDED|95.0|-28.0|-11.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-11|-28|<0.0001
71697525|NCT01265498|142910617|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-12.0||||0.0001|TWO_SIDED|95.0|-18.0|-6.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-6|-18|0.0001
71697526|NCT01265498|142910618|SUPERIORITY_OR_OTHER||Mean Difference (Net)|18.0|||<|0.0001|TWO_SIDED|95.0|13.0|24.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||24|13|<0.0001
71697527|NCT01265498|142910619|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-24.0|||<|0.0001|TWO_SIDED|95.0|-35.0|-14.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-14|-35|<0.0001
71697528|NCT01265498|142910620|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.5||||0.002|TWO_SIDED|95.0|-2.4|-0.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.5|-2.4|0.002
71697529|NCT01265498|142910621|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.38||||0.0009|TWO_SIDED|95.0|0.16|0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.60|0.16|0.0009
71697530|NCT01265498|142910622|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.06||||0.01|TWO_SIDED|95.0|-0.1|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.10|0.01
71697531|NCT01265498|142910623|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.45|||<|0.0001|TWO_SIDED|95.0|0.26|0.65|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.65|0.26|<0.0001
71697532|NCT01265498|142910624|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.88|TWO_SIDED|95.0|-0.35|0.3|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.30|-0.35|0.88
71697533|NCT01265498|142910625|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.72|TWO_SIDED|95.0|-1.8|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.8|0.72
71697534|NCT01265498|142910626|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.71|TWO_SIDED|95.0|-0.01|0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.01|-0.01|0.71
71697535|NCT01265498|142910627|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.1||||0.002|TWO_SIDED|95.0|-1.8|-0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.4|-1.8|0.002
71697536|NCT01265498|142910628|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1||||0.4|TWO_SIDED|95.0|-0.2|0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.4|-0.2|0.40
71697537|NCT01265498|142910629|SUPERIORITY_OR_OTHER||Mean Difference (Net)|16.0||||0.001|TWO_SIDED|95.0|7.0|26.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||26|7|0.001
71697538|NCT01265498|142910630|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.03|TWO_SIDED|95.0|-1.4|-0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.1|-1.4|0.03
71697539|NCT01265498|142910631|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.02||||0.04|TWO_SIDED|95.0|0.0|0.04|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.04|0.00|0.04
71697540|NCT01265498|142910632|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.01||||0.53|TWO_SIDED|95.0|-0.03|0.05|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.05|-0.03|0.53
71697541|NCT01265498|142910633|SUPERIORITY_OR_OTHER||Mean Difference (Net)|2.6||||0.03|TWO_SIDED|95.0|0.2|5.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||5.0|0.2|0.03
71697542|NCT01265498|142910634|SUPERIORITY_OR_OTHER||Mean Difference (Net)|14.0||||0.05|TWO_SIDED|95.0|0.0|29.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||29|0|0.05
71697543|NCT01265498|142910635|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.5||||0.13|TWO_SIDED|95.0|-1.2|0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.2|-1.2|0.13
71697544|NCT01265498|142910636|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.5||||0.31|TWO_SIDED|95.0|-0.5|1.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.6|-0.5|0.31
71697545|NCT01265498|142910637|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.2||||0.16|TWO_SIDED|95.0|-0.6|0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.1|-0.6|0.16
71697546|NCT01265498|142910638|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.02||||0.002|TWO_SIDED|95.0|-0.04|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.01|-0.04|0.002
71697547|NCT01265498|142910639|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.3||||0.26|TWO_SIDED|95.0|-0.2|0.8|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.8|-0.2|0.26
71697548|NCT01265498|142910640|SUPERIORITY_OR_OTHER||Mean Difference (Net)|38.0||||0.02|TWO_SIDED|95.0|6.0|69.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||69|6|0.02
71697549|NCT01265498|142910641|SUPERIORITY_OR_OTHER||Mean Difference (Net)|13.0||||0.01|TWO_SIDED|95.0|3.0|23.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||23|3|0.01
71697550|NCT01265498|142910642|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.4||||0.71|TWO_SIDED|95.0|-1.7|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2.6|-1.7|0.71
71697551|NCT01265498|142910643|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-2.2||||0.008|TWO_SIDED|95.0|-3.7|-0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.6|-3.7|0.008
71697552|NCT01265498|142910644|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.7||||0.01|TWO_SIDED|95.0|-1.3|-0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||-0.2|-1.3|0.01
71697553|NCT01265498|142910645|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.4||||0.7|TWO_SIDED|95.0|-2.2|1.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1.5|-2.2|0.70
71697554|NCT01265498|142910646|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.57|TWO_SIDED|95.0|-0.01|0.02|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0.02|-0.01|0.57
71697555|NCT01265498|142910647|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-3.0||||0.05|TWO_SIDED|95.0|-7.0|0.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||0|-7|0.05
71697556|NCT01265498|142910648|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0||||0.23|TWO_SIDED|95.0|-4.0|1.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||1|-4|0.23
71697557|NCT01265498|142910649|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.0||||0.22|TWO_SIDED|95.0|-1.0|3.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||3|-1|0.22
71697558|NCT01265498|142910650|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0||||0.65|TWO_SIDED|95.0|-3.0|2.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo|||2|-3|0.65
71697559|NCT00921024|142910651|SUPERIORITY_OR_OTHER||Risk Difference (RD)|6.8|||||TWO_SIDED|||||||||||||
71697560|NCT00921024|142910652|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-7.1|||||TWO_SIDED|||||||||||||
71697561|NCT01296412|142910684|NON_INFERIORITY_OR_EQUIVALENCE|The sitagliptin-based treatment paradigm was to be declared non-inferior to the liraglutide-based treatment paradigm in lowering A1C at Week 26 if the upper bound of 95% confidence intervals of between group difference was less than the non-inferiority margin of 0.4%.|Difference in least squares mean|0.09|||||TWO_SIDED|95.0|-0.05|0.23|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||0.23|-0.05|
71697562|NCT01296412|142910685|SUPERIORITY_OR_OTHER||Difference in least squares mean|5.9|||||TWO_SIDED|95.0|0.5|11.4|||ANCOVA|The ANCOVA model included a term for treatment paradigm and a covariate for baseline value.||||11.4|0.5|
71697563|NCT01296412|142910686|SUPERIORITY_OR_OTHER||Difference in percent|-9.5|||||TWO_SIDED|95.0|-17.4|-1.5|||Miettinen & Nurminen|||||-1.5|-17.4|
71697564|NCT01296412|142910687|SUPERIORITY_OR_OTHER||Difference in percent|-4.5|||||TWO_SIDED|95.0|-12.7|3.7|||Miettinen & Nurminen|||||3.7|-12.7|
71697565|NCT02160626|142910688|OTHER|||||||0.0003|||||||ANOVA|||||||0.0003
71697566|NCT02160626|142910688|OTHER|||||||0.0001|||||||ANOVA|||||||.0001
71697567|NCT02160626|142910689|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
71697568|NCT02160626|142910689|OTHER|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.||||0.0001
71697569|NCT02160626|142910690|OTHER|||||||0.0016||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||"Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.~A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site."||||0.0016
71697570|NCT02160626|142910690|OTHER|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||||||0.0004||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||||||0.0004
71697571|NCT00737178|142910706|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Chi-squared|||||||<.01
71697572|NCT00737178|142910708|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Chi-squared|||||||0.24
71697573|NCT00427934|142910729|SUPERIORITY_OR_OTHER||Percentage Difference|-1.73||||0.79||90.0|-15.13|8.68|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||8.68|-15.13|0.790
71697574|NCT00427934|142910729|SUPERIORITY_OR_OTHER||Percentage Difference|0.43||||0.477||90.0|-13.67|11.64|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||11.64|-13.67|0.477
71697575|NCT00427934|142910729|SUPERIORITY_OR_OTHER||Percentage Difference|3.03||||0.37||90.0|-12.85|16.77|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||16.77|-12.85|0.370
71697576|NCT00427934|142910729|SUPERIORITY_OR_OTHER||Percentage Difference|8.66||||0.175||90.0|-7.07|22.03|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||22.03|-7.07|0.175
71697577|NCT00427934|142910730|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.42||90.0|-6.34|6.01|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1||6.01|-6.34|0.420
71697578|NCT00427934|142910730|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2||7.95|-5.08|0.258
71697579|NCT00427934|142910730|SUPERIORITY_OR_OTHER||Percentage Difference|-3.46||||1||90.0|-14.39|3.42|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||3.42|-14.39|1.000
71697580|NCT00427934|142910730|SUPERIORITY_OR_OTHER||Percentage Difference|-1.3||||0.899||90.0|-13.56|7.92|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.92|-13.56|0.899
71697581|NCT00427934|142910730|SUPERIORITY_OR_OTHER||Percentage Difference|1.3||||0.489||90.0|-11.24|10.96|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||10.96|-11.24|0.489
71697582|NCT00427934|142910731|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4||1.28|-13.59|1.000
71697583|NCT00427934|142910731|SUPERIORITY_OR_OTHER||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8||7.95|-5.08|0.258
71697584|NCT00427934|142910731|SUPERIORITY_OR_OTHER||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12||1.28|-13.59|1.000
71697585|NCT00427934|142910732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.1||||0.335||90.0|-0.79|2.99||This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.99|-0.79|0.335
71697586|NCT00427934|142910732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.3||||0.816||90.0|-1.82|2.41||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.41|-1.82|0.816
71697587|NCT00427934|142910732|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.01||||0.996||90.0|-2.35|2.36||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||2.36|-2.35|0.996
71697588|NCT00427934|142910732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.61||||0.263||90.0|-3.98|0.76||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.76|-3.98|0.263
71697589|NCT00427934|142910732|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48||||0.294||90.0|-3.82|0.85||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.85|-3.82|0.294
71697590|NCT00427934|142910733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.32||||0.7||90.0|-1.7|1.06||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||1.06|-1.70|0.700
71697591|NCT00427934|142910733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.26||||0.799||90.0|-1.45|1.97||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||1.97|-1.45|0.799
71697592|NCT00427934|142910733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15||||0.867||90.0|-1.35|1.66||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||1.66|-1.35|0.867
71697593|NCT00427934|142910733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.45||||0.167||90.0|-3.17|0.28||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.28|-3.17|0.167
71697594|NCT00427934|142910733|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.966||90.0|-1.91|1.81||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.81|-1.91|0.966
71697595|NCT00427934|142910734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.34||||0.925||90.0|-6.41|5.72||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||5.72|-6.41|0.925
71697596|NCT00427934|142910734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.26||||0.239||90.0|-12.62|2.11||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.11|-12.62|0.239
71697597|NCT00427934|142910734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73||||0.872||90.0|-6.79|8.25||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||8.25|-6.79|0.872
71697598|NCT00427934|142910734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.63||||0.745||90.0|-9.91|6.65||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||6.65|-9.91|0.745
71697599|NCT00427934|142910734|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.22||||0.644||90.0|-10.14|5.71||This analysis was carried out using ANCOVA with baseline patient's assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||5.71|-10.14|0.644
71697600|NCT00427934|142910735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.36||||0.524||90.0|-8.49|3.77||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||3.77|-8.49|0.524
71697601|NCT00427934|142910735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.96||||0.338||90.0|-10.8|2.87||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||2.87|-10.80|0.338
71697602|NCT00427934|142910735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.98||||0.83||90.0|-8.55|6.58||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||6.58|-8.55|0.830
71697603|NCT00427934|142910735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.68||||0.118||90.0|-15.76|0.4||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.40|-15.76|0.118
71697604|NCT00427934|142910735|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.78||||0.712||90.0|-9.73|6.18||This analysis was carried out using ANCOVA with baseline Patient's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.18|-9.73|0.712
71697605|NCT00427934|142910736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.54||90.0|-0.28|0.13||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.13|-0.28|0.540
71697606|NCT00427934|142910736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.04||||0.757||90.0|-0.28|0.19||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||0.19|-0.28|0.757
71697607|NCT00427934|142910736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05||||0.767||90.0|-0.31|0.21||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.21|-0.31|0.767
71697608|NCT00427934|142910736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.26||||0.112||90.0|-0.52|0.01||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||0.01|-0.52|0.112
71697609|NCT00427934|142910736|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.49||90.0|-0.42|0.17||This analysis was carried out using ANCOVA with baseline Physician's Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.17|-0.42|0.490
71697610|NCT00427934|142910737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.464||90.0|-0.19|0.07||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||0.07|-0.19|0.464
71697611|NCT00427934|142910737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.18||||0.068||90.0|-0.35|-0.02||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||-0.02|-0.35|0.068
71697612|NCT00427934|142910737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.06||||0.532||90.0|-0.23|0.11||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||0.11|-0.23|0.532
71697613|NCT00427934|142910737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22||||0.063||90.0|-0.41|-0.03||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||-0.03|-0.41|0.063
71697614|NCT00427934|142910737|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.12||||0.396||90.0|-0.36|0.12||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||0.12|-0.36|0.396
71697615|NCT00427934|142910738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.2||||0.481||90.0|-7.36|2.96||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1||2.96|-7.36|0.481
71697616|NCT00427934|142910738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.33||||0.698||90.0|-4.34|6.99||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2||6.99|-4.34|0.698
71697617|NCT00427934|142910738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.65||||0.233||90.0|-1.79|11.1||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||11.10|-1.79|0.233
71697618|NCT00427934|142910738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.48||||0.32||90.0|-2.29|9.25||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8||9.25|-2.29|0.320
71697619|NCT00427934|142910738|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41||||0.912||90.0|-5.81|6.64||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||6.64|-5.81|0.912
71697620|NCT00427934|142910739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.653||90.0|-0.31|0.18||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 1||0.18|-0.31|0.653
71697621|NCT00427934|142910739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08||||0.703||90.0|-0.41|0.26||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 2||0.26|-0.41|0.703
71697622|NCT00427934|142910739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01||||0.968||90.0|-0.37|0.39||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 4||0.39|-0.37|0.968
71697623|NCT00427934|142910739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31||||0.21||90.0|-0.72|0.1||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 8||0.10|-0.72|0.210
71697624|NCT00427934|142910739|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1||||0.696||90.0|-0.53|0.33||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 12||0.33|-0.53|0.696
71697625|NCT00427934|142910741|SUPERIORITY_OR_OTHER||Percentage Difference|9.09||||0.155||90.0|-6.16|21.83||p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were \< 5 otherwise Pearson chi-square test.|Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|||21.83|-6.16|0.155
71697626|NCT00427934|142910747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.57||||0.698||90.0|-1.87|3.01||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||3.01|-1.87|0.698
71697627|NCT00427934|142910747|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.68||||0.344||90.0|-4.62|1.26||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||1.26|-4.62|0.344
71697628|NCT00427934|142910748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7||||0.734||90.0|-2.71|4.11||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4||4.11|-2.71|0.734
71697629|NCT00427934|142910748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56||||0.818||90.0|-3.5|4.62||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12||4.62|-3.50|0.818
71697630|NCT00427934|142910749|SUPERIORITY_OR_OTHER|||||||0.649||95.0|||||Fisher Exact|||||||0.649
71697631|NCT00427934|142910750|SUPERIORITY_OR_OTHER|||||||0.9826||95.0|||||Log Rank|||||||0.9826
71697632|NCT04539275|142910761|SUPERIORITY||Risk Difference (RD)|-0.01||||1|TWO_SIDED|95.0|-0.15|0.14|||Fisher Exact|||||0.14|-0.15|1.00
71697633|NCT04539275|142910762|SUPERIORITY||Improvement Rate Ratio|1.08||||0.749|TWO_SIDED|95.0|0.65|1.78|||Log Rank|||||1.78|0.65|0.749
71697634|NCT04539275|142910763|SUPERIORITY||Hazard Ratio (HR)|0.95||||0.943|TWO_SIDED|95.0|0.21|4.23|||Log Rank|||||4.23|0.21|0.943
71697635|NCT04539275|142910764|SUPERIORITY||Risk Difference (RD)|-0.08||||0.4014|TWO_SIDED|95.0|-0.25|0.1|||Chi-squared|||||0.10|-0.25|0.4014
71697636|NCT04539275|142910765|SUPERIORITY||Hazard Ratio (HR)|0.59||||0.3762|TWO_SIDED|95.0|0.18|1.96|||Log Rank|||||1.96|0.18|0.3762
71697637|NCT04539275|142910766|SUPERIORITY||Risk Difference (RD)|-0.04||||0.6867|TWO_SIDED|95.0|-0.17|0.09|||Fisher Exact|||||0.09|-0.17|0.6867
71697638|NCT04539275|142910767|SUPERIORITY||Improvement Rate Ratio|1.11||||0.6494|TWO_SIDED|95.0|0.68|1.83|||Log Rank|||||1.83|0.68|0.6494
71697639|NCT04539275|142910768|SUPERIORITY||Improvement Rate Ratio|0.98||||0.9338|TWO_SIDED|95.0|0.59|1.63|||Log Rank|||||1.63|0.59|0.9338
71697640|NCT04539275|142910772|SUPERIORITY||Improvement Rate Ratio|1.14||||0.5682|TWO_SIDED|95.0|0.7|1.86|||Log Rank|||||1.86|0.70|0.5682
71697641|NCT04539275|142910774|SUPERIORITY||Median Difference (Final Values)|0.0||||0.8642|TWO_SIDED|95.0|-2.3|2.3|||Wilcoxon (Mann-Whitney)|||||2.3|-2.3|0.8642
71697642|NCT01373164|142910779|SUPERIORITY|The planned primary analysis for this study utilized a Bayesian exponential-likelihood model, incorporating historical overall survival (OS) data from 2 studies (Oettle et al. 2005; Saif et al. 2009). The primary analysis was performed using strong borrowing from the historical data. The model was estimated to borrow approximately 37 events from the historical studies.|Hazard Ratio (HR)|0.794|||||TWO_SIDED|95.0|0.59|1.085|||Bayesian Analysis|Primary comparison was to be considered successful if there was at least 0.85 posterior probability that the hazard ratio (HR) for OS of LY+Gem is \<1.|This is a Credible Interval estimated from the Bayesian analysis.|||1.085|0.590|
71697643|NCT01799941|142910790|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71697644|NCT01799941|142910790|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||one-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71697645|NCT01799941|142910790|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71697646|NCT01799941|142910790|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.||||<0.0001
71697647|NCT01799941|142910790|SUPERIORITY_OR_OTHER||Analysis of covariance (ANCOVA)|0.04|STANDARD_ERROR_OF_MEAN|0.72|||TWO_SIDED|95.0|-1.37|1.45|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||1.45|-1.37|
71697648|NCT01799941|142910790|SUPERIORITY_OR_OTHER||ANCOVA|1.11|STANDARD_ERROR_OF_MEAN|0.8|||TWO_SIDED|95.0|-0.46|2.68|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.68|-0.46|
71697649|NCT01799941|142910790|SUPERIORITY_OR_OTHER||ANCOVA|1.15|STANDARD_ERROR_OF_MEAN|0.78|||TWO_SIDED|95.0|-0.39|2.69|||||A positive estimate indicates a smaller change in the first group. Observations used =261.|||2.69|-0.39|
71697650|NCT01799941|142910791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697651|NCT01799941|142910791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697652|NCT01799941|142910791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697653|NCT01799941|142910791|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697654|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71697655|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
71697656|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71697657|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 assessment||||<0.0001
71697658|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71697659|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
71697660|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline||||<0.0001
71697661|NCT01799941|142910792|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline||||<0.0001
71697662|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.425|STANDARD_ERROR_OF_MEAN|0.023|<|0.0001|TWO_SIDED|95.0|0.407|0.445|||Mixed Effects Poisson Regreesion Model||Number of observations = 854, Number of participants = 298|Day 30 assessment||0.445|0.407|<0.0001
71697663|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.277|STANDARD_ERROR_OF_MEAN|0.028|<|0.0001|TWO_SIDED|95.0|0.262|0.293|||Mixed Effects Poisson Regression Model||Number of observations = 854, Number of participants = 298|Day 90 assessment||0.293|0.262|<0.0001
71697664|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.5|STANDARD_ERROR_OF_MEAN|0.033|<|0.0001|TWO_SIDED|95.0|0.469|0.534|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 30 assessment||0.534|0.469|<0.0001
71697665|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.323|STANDARD_ERROR_OF_MEAN|0.039|<|0.0001|TWO_SIDED|95.0|0.299|0.349|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 90 assessment||0.349|0.299|<0.0001
71697666|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.351|STANDARD_ERROR_OF_MEAN|0.044|<|0.0001|TWO_SIDED|95.0|0.323|0.383|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 30 assessment||0.383|0.323|<0.0001
71697667|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.255|STANDARD_ERROR_OF_MEAN|0.051|<|0.0001|TWO_SIDED|95.0|0.231|0.282|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 90 assessment||0.282|0.231|<0.0001
71697668|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.387|STANDARD_ERROR_OF_MEAN|0.048|<|0.0001|TWO_SIDED|95.0|0.352|0.425|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 30 assessment||0.425|0.352|<0.0001
71697669|NCT01799941|142910794|SUPERIORITY_OR_OTHER||Incidence Rate Ratio|0.215|STANDARD_ERROR_OF_MEAN|0.066|<|0.0001|TWO_SIDED|95.0|0.189|0.245|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 90 assessment||0.245|0.189|<0.0001
71697670|NCT01799941|142910797|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697671|NCT01799941|142910797|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697672|NCT01799941|142910797|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697673|NCT01799941|142910797|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||One-sample t-test|||||||<0.0001
71697674|NCT02419807|142910872|EQUIVALENCE|Equivalence is defined as the difference in the proportions of nodes flagged between the Tc and ICG methods falling within an interval (-δ, +δ), where δ is taken to be 5%.|Mean Difference (Final Values)|0.09|||||TWO_SIDED|95.0|0.036|0.151||||||||0.151|0.036|
71697675|NCT02932943|142910913|SUPERIORITY||Least Squares Mean Difference|0.3||||0.6482|TWO_SIDED|95.0|-1.07|1.72|||Mixed Model Repeated Measures (MMRM)|||||1.72|-1.07|0.6482
71697676|NCT02932943|142910914|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.559|TWO_SIDED|95.0|-1.61|0.87|||Mixed Model Repeated Measures (MMRM)|||||0.87|-1.61|0.5590
71697677|NCT02932943|142910915|SUPERIORITY||Least Squares Mean Difference|0.2||||0.8131|TWO_SIDED|95.0|-1.53|1.95|||Mixed Model Repeated Measures (MMRM)|||||1.95|-1.53|0.8131
71697678|NCT02932943|142910916|SUPERIORITY||Least Squares Mean Difference|-0.4||||0.6108|TWO_SIDED|95.0|-2.05|1.21|||Mixed Model Repeated Measures (MMRM)|||||1.21|-2.05|0.6108
71697679|NCT01462942|142910962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.125|||<|0.0001|TWO_SIDED|95.0|0.09|0.16|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.160|0.090|<0.0001
71697680|NCT01462942|142910962|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.069||||0.0001|TWO_SIDED|95.0|0.034|0.105|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.105|0.034|0.0001
71697681|NCT01462942|142910963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.085|||<|0.0001|TWO_SIDED|95.0|0.051|0.119|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.119|0.051|<0.0001
71697682|NCT01462942|142910963|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|0.053||||0.0022|TWO_SIDED|95.0|0.019|0.087|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors||||0.087|0.019|0.0022
71697683|NCT01462942|142910964|SUPERIORITY_OR_OTHER||Least squares mean difference|1.293|||<|0.0001|TWO_SIDED|95.0|0.728|1.859|||Mixed Models Analysis|Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.859|0.728|<0.0001
71697684|NCT01462942|142910964|SUPERIORITY_OR_OTHER||Least Squares Mean Difference|1.162|||<|0.0001|TWO_SIDED|95.0|0.593|1.73|||Mixed Models Analysis|||Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||1.730|0.593|<0.0001
71697685|NCT01462942|142910965|SUPERIORITY_OR_OTHER||Least squares mean difference|-0.653||||0.598|TWO_SIDED|95.0|-3.082|1.776|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||1.776|-3.082|0.5980
71697686|NCT01462942|142910965|SUPERIORITY_OR_OTHER||Least squares mean difference|-1.828||||0.1406|TWO_SIDED|95.0|-4.259|0.604|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors||||0.604|-4.259|0.1406
71697687|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).|GMC ratio|0.16|||||TWO_SIDED|95.0|0.14|0.18||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1."||0.18|0.14|
71697688|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1106 in the 105553 10Pn Group; GMC= 1.45 µg/mL with 95% CI = (1.38 to 1.53).|GMC ratio|0.22|||||TWO_SIDED|95.0|0.2|0.25||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4."||0.25|0.2|
71697689|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.70 µg/mL with 95% CI = (1.62 to 1.78).|GMC ratio|0.26|||||TWO_SIDED|95.0|0.23|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5."||0.29|0.23|
71697690|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 0.33 µg/mL with 95% CI = (0.30 to 0.36).|GMC ratio|0.19|||||TWO_SIDED|95.0|0.16|0.23||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B."||0.23|0.16|
71697691|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1107 in the 105553 10Pn Group; GMC= 1.72 µg/mL with 95% CI = (1.64 to 1.80).|GMC ratio|0.28|||||TWO_SIDED|95.0|0.25|0.31||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F."||0.31|0.25|
71697692|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1103 in the 105553 10Pn Group; GMC= 1.32 µg/mL with 95% CI = (1.25 to 1.38).|GMC ratio|0.24|||||TWO_SIDED|95.0|0.22|0.27||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V."||0.27|0.22|
71697693|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 2.90 µg/mL with 95% CI = (2.75 to 3.05).|GMC ratio|0.29|||||TWO_SIDED|95.0|0.25|0.33||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14."||0.33|0.25|
71697694|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 1.66 µg/mL with 95% CI = (1.56 to 1.77).|GMC ratio|0.1|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C."||0.12|0.09|
71697695|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.84 µg/mL with 95% CI = (1.71 to 1.98).|GMC ratio|0.11|||||TWO_SIDED|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F."||0.12|0.09|
71697696|NCT01027845|142910966|NON_INFERIORITY|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 0.53 µg/mL with 95% CI = (0.50 to 0.57).|GMC ratio|0.25|||||TWO_SIDED|95.0|0.21|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F."||0.29|0.21|
71697697|NCT04465422|142911000|SUPERIORITY||Mean Difference (Final Values)|3.2|STANDARD_ERROR_OF_MEAN|0.97|<|0.001|TWO_SIDED|95.0|1.65|5.55|||Mixed Models Analysis|||Statistical Anaiysis 1 is according to Occupational Performance History Interview - II (OPHI-II) total score.||5.55|1.65|<0.001
71761216|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0219|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.||||0.0219
71697698|NCT04465422|142911000|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.53||0.019|TWO_SIDED|95.0|0.23|2.37|||Mixed Models Analysis|||Statistical Analysis 2 is based on Occupational Identity(range 11\~44；higher scores indicates better performance), a sub-domain of OPHI-II. The Occupational Identity scale is designed to measure the degree to which a client has internalized a positive occupational identity (i.e., has values, interests, and confidence; sees self in various occupational roles; has an image of the kind of life desired)||2.37|0.23|0.019
71697699|NCT04465422|142911000|SUPERIORITY||Mean Difference (Final Values)|1.4|STANDARD_ERROR_OF_MEAN|0.43||0.006|TWO_SIDED|95.0|0.38|2.11|||Mixed Models Analysis|||Statistical Analysis 3 is based on Occupational Competence(range 9\~36；higher scores indicate better performance), a sub-domain of OPHI-II. The Occupational Competence scale is designed to measure the degree to which a client is able to sustain a pattern of occupational behavior that is productive and satisfying.||2.11|0.38|0.006
71697700|NCT04465422|142911000|SUPERIORITY||Mean Difference (Final Values)|0.9|STANDARD_ERROR_OF_MEAN|0.38||0.136|TWO_SIDED|95.0|-0.19|1.35|||Mixed Models Analysis|||Statistical Analysis 4 is based on Occupational Behavior Settings(range 9\~36；higher scores indicate greater performance), a sub-domain of OPHI-II. The Occupational Behavior Settings scale addresses the impact of the environment on the person's occupational life.||1.35|-0.19|0.136
71697701|NCT04465422|142911001|SUPERIORITY||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|1.53||0.592|TWO_SIDED|95.0|-3.9|2.25|||Mixed Models Analysis|||Statistical Analysis 1 is based on Lawton Instrumental Activities Daily Living (range 0\~23；the higher scores indicate greater performance) total scores.||2.25|-3.90|0.592
71697702|NCT04465422|142911001|SUPERIORITY||Mean Difference (Final Values)|4.1|STANDARD_ERROR_OF_MEAN|2.37||0.302|TWO_SIDED|95.0|-2.29|7.23|||Mixed Models Analysis|||Statistical Analysis 2 is based on Comprehensive Occupational Therapy Evaluation Scale (range 20\~100；the higher scores indicate greater performance) total scores.||7.23|-2.29|0.302
71697703|NCT04465422|142911001|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|3.25||0.931|TWO_SIDED|95.0|-6.25|6.82|||Mixed Models Analysis|||Statistical Analysis 3 is based on Personal and Social Performance scale (range 1\~100；the higher scores indicate greater performance) total scores.||6.82|-6.25|0.931
71697704|NCT04465422|142911001|SUPERIORITY||Mean Difference (Final Values)|-1.4|STANDARD_ERROR_OF_MEAN|0.85||0.981|TWO_SIDED|95.0|-1.73|1.69|||Mixed Models Analysis|||Statistical Analysis 4 is based on Canadian Occupational Performance Measure (range 1\~10；the higher scores indicate greater performance) total scores.||1.69|-1.73|0.981
71697705|NCT00997893|142911035|OTHER|||||||0.004||||||treatment x time p=.004|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo. Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.004
71697706|NCT00997893|142911036|OTHER|||||||0.98||||||visit x time x treatment interaction p=.98|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo before and after a psychosocial stressor. Predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.98
71697707|NCT00997893|142911037|OTHER|||||||0.68||||||treatment x time (before and after the psychosocial stressor) x visit p=.68|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on emotional memory following a laboratory induced stress. Primary predictor variables in the model included treatment, time (before and after the psychosocial stressor), visit (Baseline, 12 weeks), and all two and three way interactions.|||.68
71697708|NCT00997893|142911038|OTHER|||||||0.11||||||treatment x time p=.11|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate). Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.11
71697709|NCT00997893|142911039|OTHER|||||||0.86||||||treatment x time p=.86|Mixed Models Analysis||||A mixed effects regression model (Estimation method=maximum likelihood; Random intercept) was conducted to compare the effects of phytoestrogens and estradiol to placebo on verbal memory (logical memory; immediate)Primary predictor variables in the model included treatment and time, as well the treatment by time interaction.|||.86
71697710|NCT03444584|142911040|SUPERIORITY||LS mean difference|-143.09|||<|0.0001|TWO_SIDED|95.0|-198.2|-87.98|||ANCOVA|||||-87.98|-198.20|<0.0001
71697711|NCT03444584|142911041|SUPERIORITY||LS mean difference|-22.17|||<|0.0001|TWO_SIDED|95.0|-30.24|-14.1|||ANCOVA|||||-14.10|-30.24|<0.0001
71697712|NCT01142336|142911069|SUPERIORITY|||||||0.53||||||Threshold for significance: 0.05, adjust for 3 primary outcomes using Holm Correction|ANCOVA|Response variable was Aβ42 in CSF at 1 year, and predictor variables were Aβ42 in CSF at baseline, treatment group, age, sex, and APOE e4 allele.||||||0.53
71697713|NCT01142336|142911070|SUPERIORITY|||||||0.36||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction|ANCOVA|Response variable was total tau in CSF at 1 year, and predictor were total tau in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.36
71697714|NCT01142336|142911071|SUPERIORITY|||||||0.25||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction.|ANCOVA|Response variable was p-tau181 in CSF at 1 year, and predictor were p-tau181 in at baseline, treatment group, age, sex, and APOE e4 allele status||||||0.25
71697715|NCT01704261|142911072|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.61|||<|0.001|TWO_SIDED|95.0|-0.85|-0.38|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-0.38|-0.85|<0.001
71697716|NCT01704261|142911073|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|9.8|||||TWO_SIDED|95.0|-1.4|20.8||||||||20.8|-1.4|
71697717|NCT01704261|142911074|SUPERIORITY_OR_OTHER||Difference in % Omarigliptin vs Placebo|0.0|||||TWO_SIDED|95.0|-4.3|4.3||||||||4.3|-4.3|
71697718|NCT01704261|142911075|SUPERIORITY_OR_OTHER||Difference of the least squares means|-16.6|||<|0.001|TWO_SIDED|95.0|-25.5|-7.8|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.||||-7.8|-25.5|<0.001
71697719|NCT01704261|142911076|SUPERIORITY_OR_OTHER||Between-group Rate Difference|19.3|||<|0.001|TWO_SIDED|95.0|11.7|27.6|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||27.6|11.7|<0.001
71697720|NCT01704261|142911076|SUPERIORITY_OR_OTHER||Between-group Rate Difference (%)|8.0||||0.005|TWO_SIDED|95.0|2.7|14.5|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C \<7.0%; estimated using standard multiple imputation techniques.||||14.5|2.7|0.005
71697721|NCT00071981|142911087|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare CTL response rate among four arms. The null hypothesis is that CTL response is same in all four arms. Alternative hypothesis is that CTL response rate is different in at least one arm compared to other arms.||||<0.001
71697722|NCT00071981|142911088|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to 6MHP among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
71697723|NCT00071981|142911089|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001|TWO_SIDED|95.0|||||Fisher Exact|||Compare HTL response rate to tetanus peptide among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.||||<0.001
71697724|NCT00071981|142911090|SUPERIORITY_OR_OTHER_LEGACY|||||||0.741|TWO_SIDED|95.0|||||Fisher Exact|||Compare objective response rate among four arms. The null hypothesis is that objective response rate is same in all four arms. Alternative hypothesis is that objective response rate is different in at least one arm compared to other arms.||||0.741
71697725|NCT00071981|142911091|SUPERIORITY_OR_OTHER_LEGACY|||||||0.532|TWO_SIDED|95.0|||||Log Rank|||Compare overall survival curves among four arms.||||0.532
71697726|NCT01123655|142911102|EQUIVALENCE|P less than 0.05 was the criteria for equivalence.||||||0.5179|||||||Fisher Exact|||Specified to be a reduction from baseline values of net IFNƔ concentration of ≥ 25% in αl(ll)-stimulated PBMC culture supernatants (calculated as αI(II)-IFNƔ-PBS IFNƔ in patients receiving APL A12 compared to placebo.||||0.5179
71697727|NCT01123655|142911102|EQUIVALENCE|Null hypothesis was that the response rate in the APL treated groups is not significantly difference from the 50% spontaneous response rate.||||||0.0114|||||||Exact Test|||||||0.0114
71697728|NCT01123655|142911102|EQUIVALENCE|Null hypothesis was that the response rate in the placebo group is not significantly difference from the 50% spontaneous response rate.||||||0.4142|||||||Exact Test|||||||0.4142
71697729|NCT01123655|142911104|EQUIVALENCE|P greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable for baseline and follow-up data.|Mixed Models Analysis|||||||>0.05
71697730|NCT01123655|142911105|EQUIVALENCE|p value greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable to IL-17a, IL-10, IL-1b, IL-9, IL-13, IL-5, IL-21, IL-6, TNFa, TGFb, MIP3a.|t-test, 2 sided|||||||>0.05
71697731|NCT00062166|142911137|NON_INFERIORITY|Time dependent risk for requiring an intervention for pancreatic neuroendocrine tumors (PNET), among 63 patients with PNETs with diameter \>1.2 and \<3 cm, and a known position of germline VHL pathogenic variant (n=63). Comparison between exon 3 vs exon 1 and 2.|Hazard Ratio (HR)|3.3||||0.02|TWO_SIDED|95.0|1.2|9.1|||Regression, Cox|||||9.1|1.2|0.02
71697732|NCT00833755|142911141|SUPERIORITY_OR_OTHER_LEGACY|||||||0.274|||||||Kruskal-Wallis|||||||0.274
71697733|NCT00833755|142911142|SUPERIORITY_OR_OTHER_LEGACY|||||||0.552|||||||Kruskal-Wallis|||||||0.552
71697734|NCT00833755|142911143|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|||||||Kruskal-Wallis|||||||0.004
71697735|NCT02439164|142911144|SUPERIORITY||Mean Difference (Net)|23.51|||<|0.01|TWO_SIDED|95.0|14.16|32.87|||t-test, 2 sided|bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.|this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.||Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,|32.87|14.16|<0.01
71697736|NCT02343224|142911150|OTHER||Kaplan-Meier estimate|76.2|||||TWO_SIDED|95.0|52.1|100.0||||||This Kaplan-Meier estimate is the conditional probability of event-free survival among study participants at 12 and 24 months.||100|52.1|
71697737|NCT02343224|142911151|OTHER||Kaplan-Meier estimate|75.0|||||TWO_SIDED|95.0|50.3|100.0||||||This Kaplan-Meier estimate is the conditional probability of overall survival among participants at 12 and 24 months.||100|50.3|
71697738|NCT02475369|142911177|SUPERIORITY|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||||||0.271
71697739|NCT02475369|142911178|OTHER|In order to calculate a correlation between baseline fecal elastase-1 and total CeD-GSRS score on PES treatment vs. placebo treatment, we calculated a Spearman's rank correlation coefficient between the two independent variables.||||||0.995|||||||Spearman rank coefficient|||||||0.995
71697740|NCT02475369|142911179|OTHER|In order to evaluate the estimated difference of the effect of Pancreatic Enzyme Supplement versus Placebo for the Celiac Symptom Index (CSI) scores, we used a linear mixed effects model with the nlme package.||||||0.08|||||||Linear Mixed Effects model|||||||0.08
71697741|NCT01420536|142911263|SUPERIORITY_OR_OTHER_LEGACY|||||||0.569|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.||||0.569
71697742|NCT01420536|142911264|SUPERIORITY_OR_OTHER_LEGACY|||||||0.339|TWO_SIDED|95.0||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.339
71697743|NCT01420536|142911265|SUPERIORITY|||||||0.515||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.515
71697744|NCT01420536|142911266|SUPERIORITY_OR_OTHER_LEGACY|||||||0.485||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.485
71697745|NCT01420536|142911267|SUPERIORITY_OR_OTHER_LEGACY|||||||0.111||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.111
71697746|NCT01420536|142911268|SUPERIORITY_OR_OTHER_LEGACY|||||||0.399||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.399
71697747|NCT01420536|142911269|SUPERIORITY_OR_OTHER_LEGACY|||||||0.55||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.550
71697748|NCT01420536|142911270|SUPERIORITY_OR_OTHER_LEGACY|||||||0.609||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.609
71697749|NCT01420536|142911271|SUPERIORITY_OR_OTHER_LEGACY|||||||0.6||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.600
71697750|NCT01420536|142911272|SUPERIORITY_OR_OTHER_LEGACY|||||||0.611||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.611
71697751|NCT01420536|142911273|SUPERIORITY_OR_OTHER_LEGACY|||||||0.044||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.044
71697752|NCT01420536|142911274|SUPERIORITY_OR_OTHER_LEGACY|||||||0.677||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.677
71697753|NCT01420536|142911275|SUPERIORITY_OR_OTHER_LEGACY|||||||0.885||||||P values less than 0.05 would be considered statistically significant in this study.|t-test, 2 sided|Paired t-test.||For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.||||0.885
71697754|NCT03054428|142911276|SUPERIORITY||percentage difference|22.0|||<|0.0001|TWO_SIDED|95.0|12.2|31.87||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (less than \[\<\] 60 kilogram \[kg\] vs greater than or equal to \[≥\] 60 kg).||31.87|12.2|< 0.0001
71697755|NCT03054428|142911276|SUPERIORITY||percentage difference|15.5|||=|0.0007|TWO_SIDED|95.0|6.7|24.31||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||24.31|6.7|= 0.0007
71697756|NCT03054428|142911277|SUPERIORITY||percentage difference|33.2|||<|0.0001|TWO_SIDED|95.0|21.07|45.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||45.39|21.07|< 0.0001
71697757|NCT03054428|142911277|SUPERIORITY||percentage difference|29.9|||<|0.0001|TWO_SIDED|95.0|17.94|41.78||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (\<60 kg vs ≥60 kg).||41.78|17.94|< 0.0001
71697758|NCT03054428|142911278|SUPERIORITY||Least Square (LS) Mean difference|-42.3|||<|0.0001|TWO_SIDED|95.0|-55.6|-29.04||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-29.04|-55.6|< 0.0001
71697759|NCT03054428|142911278|SUPERIORITY||LS Mean difference|-41.2|||<|0.0001|TWO_SIDED|95.0|-54.44|-28.02||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-28.02|-54.44|< 0.0001
71697760|NCT03054428|142911279|SUPERIORITY||LS Mean difference|-29.0|||<|0.0001|TWO_SIDED|95.0|-39.54|-18.38||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||-18.38|-39.54|< 0.0001
71697761|NCT03054428|142911279|SUPERIORITY||LS Mean difference|-26.5|||<|0.0001|TWO_SIDED|95.0|-37.45|15.63||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\]) as fixed factors.||15.63|-37.45|< 0.0001
71697762|NCT03054428|142911280|SUPERIORITY||percentage difference|39.4|||<|0.0001|TWO_SIDED|95.0|26.9|51.84||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by CMH test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||51.84|26.9|< 0.0001
71697763|NCT03054428|142911280|SUPERIORITY||percentage difference|29.1|||<|0.0001|TWO_SIDED|95.0|16.97|41.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||41.32|16.97|< 0.0001
71697764|NCT03054428|142911281|SUPERIORITY||Percentage difference|31.8|||<|0.0001|TWO_SIDED|95.0|20.45|43.2||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||43.2|20.45|< 0.0001
71697765|NCT03054428|142911281|SUPERIORITY||Percentage difference|21.7|||=|0.0001|TWO_SIDED|95.0|11.21|32.28||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity \[IGA=3 vs IGA=4\] and baseline weight group \[\<60 kg vs ≥60 kg\].||32.28|11.21|= 0.0001
71697766|NCT03880474|142911344|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Log Binominal Model|||||2.55|0.90|0.1146
71697767|NCT03880474|142911344|OTHER||Relative Risk|1.52||||0.1146|TWO_SIDED|95.0|0.9|2.55|||Poisson Model with Robust Variance|||||2.55|0.90|0.1146
71697768|NCT03880474|142911345|OTHER||Relative Risk|1.0||||1|TWO_SIDED|95.0|0.86|1.15|||Log Binomial Model|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|1.0000
71697769|NCT03880474|142911345|OTHER||Relative Risk|1.0||||0.9799|TWO_SIDED|95.0|0.86|1.15|||Poisson Model with Robust Variance|||The Analysis concerns the Incidence of Influenza-like Illness (ILI)||1.15|0.86|0.9799
71697770|NCT03880474|142911347|OTHER||Least Squares Mean Difference|-287.1||||0.3284|TWO_SIDED|95.0|-872.75|298.59|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Day 28||298.59|-872.75|0.3284
71697771|NCT03880474|142911347|OTHER||Least Squares Mean Difference|-13.39||||0.8468|TWO_SIDED|95.0|-152.26|125.47|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Week26||125.47|-152.26|0.8468
71697772|NCT03880474|142911347|OTHER||Least Squares Mean Difference|-465.7||||0.5087|TWO_SIDED|95.0|-1875.21|943.75|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Day 28||943.75|-1875.21|0.5087
71697773|NCT03880474|142911347|OTHER||Least Squares Mean Difference|-83.68||||0.7509|TWO_SIDED|95.0|-611.67|444.32|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Week 26||444.32|-611.67|0.7509
71697774|NCT03880474|142911347|OTHER||Least Squares Mean Difference|-81.17||||0.3398|TWO_SIDED|95.0|-250.72|88.39|||ANOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Day 28||88.39|-250.72|0.3398
71697775|NCT03880474|142911347|OTHER||Least Squares Mean Difference|26.15||||0.4154|TWO_SIDED|95.0|-37.95|90.26|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Week 26||90.26|-37.95|0.4154
71697776|NCT03880474|142911347|OTHER||Least Squares Mean Difference|22.84||||0.7193|TWO_SIDED|95.0|-104.5|150.18|||ANCOVA|||Titers of neutralizing antibodies against Influenza B/ Victoria at Day 28||150.18|-104.50|0.7193
71697777|NCT03880474|142911347|OTHER||Least Squares Mean Difference|52.38||||0.1496|TWO_SIDED|95.0|-19.59|124.35|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/ Victoria at Week 26||124.35|-19.59|0.1496
71697778|NCT03880474|142911347|OTHER||Least Squares Mean Difference|-16.76||||0.9044|TWO_SIDED|95.0|-296.57|263.06|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Day 28||263.06|-296.57|0.9044
71697779|NCT03880474|142911347|OTHER||Least Squares Mean Difference|38.64||||0.4198|TWO_SIDED|95.0|-56.97|134.24|||ANCOVA|||Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Week 26||134.24|-56.97|0.4198
71697780|NCT03880474|142911348|OTHER||Hazard Ratio (HR)|1.08||||0.4159|TWO_SIDED|95.0|0.9|1.28|||Regression, Cox|||||1.28|0.90|0.4159
71697781|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.955|TWO_SIDED|95.0|0.83|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Feeling Hot (AUC)||1.19|0.83|0.9550
71697782|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.0||||0.8933|TWO_SIDED|95.0|1.0|1.0|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Temperature (AUC)||1|1|0.8933
71697783|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2156|TWO_SIDED|95.0|0.7|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Cough (AUC)||1.09|0.7|0.2156
71697784|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.88||||0.2216|TWO_SIDED|95.0|0.71|1.1|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Sore Throat AUC||1.10|0.71|0.2216
71697785|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.87||||0.2306|TWO_SIDED|95.0|0.69|1.09|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Blocked Nose AUC||1.09|0.69|0.2306
71697786|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|0.99||||0.8038|TWO_SIDED|95.0|0.97|1.13|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Chest Pain AUC||1.13|0.97|0.8038
71697787|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.9319|TWO_SIDED|95.0|0.84|1.21|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Muscle Pain AUC||1.21|0.84|0.9319
71697788|NCT03880474|142911349|OTHER||Geometric Mean Ratio (Active vs Placebo)|1.01||||0.8399|TWO_SIDED|95.0|0.86|1.19|||ANOVA|||Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Shortness of Breath AUC||1.19|0.86|0.8399
71697789|NCT03880474|142911350|OTHER||Least Squares Mean Difference|743.78||||0|TWO_SIDED|95.0|443.71|1043.84|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Day 28 Nucleoprotein = NP, matrix1 = M1||1043.84|443.71|0
71697790|NCT03880474|142911350|OTHER||Least Squares Mean Difference|177.1||||0.0673|TWO_SIDED|95.0|-13.14|367.33|||ANCOVA|||Statistical analysis was performed for Total(NP+M) (SFU/10\^6 PBMC) at Week 26 Nucleoprotein = NP, matrix1 = M1||367.33|-13.14|0.0673
71697791|NCT00434252|142911429|SUPERIORITY_OR_OTHER||Difference in survival rates|3.5||||0.5724||95.0|-8.7|15.7|||z-test|z-test using the standard errors computed using Greenwood's method.||||15.7|-8.7|0.5724
71697792|NCT00434252|142911430|SUPERIORITY_OR_OTHER||Difference in event rates|12.2||||0.0982||95.0|-2.3|26.6|||z-test|z-test using the standard errors computed using Greenwood's method||||26.6|-2.3|0.0982
71697793|NCT02807259|142911432|EQUIVALENCE|Power calculations did not account for stratification used in the randomisation or include adjustment for baseline levels of the outcome, since the correlation over time was not known. Results suggested that the trial had \>80% power to detect a risk ratio of 0.77, if the coefficient of between-cluster variation was between 0.15 and 0.25.|Odds Ratio (OR)|1.47||||0.298|TWO_SIDED|95.0|0.71|3.01|||Mixed Models Analysis|||Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).||3.01|0.71|0.298
71697794|NCT02807259|142911433|OTHER||Odds Ratio (OR)|1.38||||0.378|TWO_SIDED|95.0|0.68|2.81|||Mixed Models Analysis|||||2.81|0.68|0.378
71697795|NCT02807259|142911434|OTHER||Odds Ratio (OR)|0.93||||0.748|TWO_SIDED|95.0|0.58|1.47|||Mixed Models Analysis|||||1.47|0.58|0.748
71697796|NCT02807259|142911435|OTHER||Odds Ratio (OR)|0.62||||0.025|TWO_SIDED|95.0|0.4|0.94|||Mixed Models Analysis|||||0.94|0.4|0.025
71697797|NCT02807259|142911436|OTHER||Odds Ratio (OR)|2.07||||0.372|TWO_SIDED|95.0|0.42|10.26|||Mixed Models Analysis|||||10.26|0.42|0.372
71697798|NCT02807259|142911437|OTHER||Odds Ratio (OR)|0.96||||0.845|TWO_SIDED|95.0|0.61|1.5|||Mixed Models Analysis|||||1.50|0.61|0.845
71697799|NCT02807259|142911438|OTHER||Odds Ratio (OR)|1.69||||0.042|TWO_SIDED|95.0|1.02|2.82|||Mixed Models Analysis|||||2.82|1.02|0.042
71697800|NCT01125930|142911453|SUPERIORITY_OR_OTHER|||||||0.93|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.93
71697801|NCT01125930|142911454|SUPERIORITY_OR_OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.79
71697802|NCT01125930|142911455|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.94
71697803|NCT01125930|142911455|SUPERIORITY_OR_OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.57
71697804|NCT01125930|142911455|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
71697805|NCT01125930|142911455|SUPERIORITY_OR_OTHER|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.38
71697806|NCT01125930|142911455|SUPERIORITY_OR_OTHER|||||||0.24|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.24
71697807|NCT01125930|142911456|SUPERIORITY_OR_OTHER|||||||0.87|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.||||0.87
71697808|NCT01125930|142911457|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.||||1.00
71697809|NCT01125930|142911457|SUPERIORITY_OR_OTHER|||||||0.62|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.62
71697810|NCT01125930|142911457|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
71697811|NCT01125930|142911457|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||1.00
71697812|NCT01125930|142911457|SUPERIORITY_OR_OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea||||0.45
71697813|NCT01125930|142911458|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71697814|NCT01125930|142911458|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71697815|NCT01125930|142911458|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71697816|NCT01125930|142911458|SUPERIORITY_OR_OTHER|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||0.53
71697817|NCT01125930|142911458|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.||||1.00
71697818|NCT01125930|142911459|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
71697819|NCT01125930|142911459|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.41
71697820|NCT01125930|142911459|SUPERIORITY_OR_OTHER|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.66
71697821|NCT01125930|142911459|SUPERIORITY_OR_OTHER|||||||0.92|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.92
71697822|NCT01125930|142911459|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||0.80
71697823|NCT01125930|142911460|SUPERIORITY_OR_OTHER|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TAC1 at Week 24 visit were made using fold change data.||||0.003
71697824|NCT01125930|142911460|SUPERIORITY_OR_OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCR4 at Week 24 visit were made using fold change data.||||0.35
71697825|NCT01125930|142911460|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCL12 at Week 24 visit were made using fold change data.||||0.68
71697826|NCT01125930|142911460|SUPERIORITY_OR_OTHER|||||||0.76|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TNFa at Week 24 visit were made using fold change data.||||0.76
71697827|NCT01125930|142911461|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-1 at Week 24 visit were made using fold change data.||||1.00
71697828|NCT01125930|142911461|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-3 at Week 24 visit were made using fold change data.||||0.25
71697829|NCT01125930|142911461|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-1 at Week 24 visit were made using fold change data.||||0.41
71697830|NCT01125930|142911461|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-3 at Week 24 visit were made using fold change data.||||0.02
71697831|NCT01125930|142911461|SUPERIORITY_OR_OTHER|||||||0.61|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-9 at Week 24 visit were made using fold change data.||||0.61
71697832|NCT01125930|142911462|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||1.00
71697833|NCT01125930|142911462|SUPERIORITY_OR_OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.44
71697834|NCT01125930|142911462|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.41
71697835|NCT01125930|142911462|SUPERIORITY_OR_OTHER|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.||||0.94
71697836|NCT01125930|142911463|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
71697837|NCT01125930|142911464|SUPERIORITY_OR_OTHER|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.13
71697838|NCT01125930|142911465|SUPERIORITY_OR_OTHER|||||||1|||||||Fisher Exact|||Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.||||1.00
71697839|NCT01125930|142911466|SUPERIORITY_OR_OTHER|||||||0.75|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.75
71697840|NCT01125930|142911467|SUPERIORITY_OR_OTHER|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.68
71697841|NCT01125930|142911468|SUPERIORITY_OR_OTHER|||||||0.77|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.77
71697842|NCT01125930|142911469|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.41
71697843|NCT01125930|142911469|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||1.00
71697844|NCT01125930|142911469|SUPERIORITY_OR_OTHER|||||||0.96|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.96
71697845|NCT01125930|142911469|SUPERIORITY_OR_OTHER|||||||0.91|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.||||0.91
71697846|NCT01125930|142911470|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
71697847|NCT01125930|142911470|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
71697848|NCT01125930|142911470|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.15
71697849|NCT01125930|142911470|SUPERIORITY_OR_OTHER|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.||||0.29
71697850|NCT01125930|142911471|SUPERIORITY_OR_OTHER|||||||0.54|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.54
71697851|NCT01125930|142911471|SUPERIORITY_OR_OTHER|||||||0.06|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.06
71697852|NCT01125930|142911471|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.02
71697853|NCT01125930|142911471|SUPERIORITY_OR_OTHER|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.||||0.09
71697854|NCT01125930|142911472|SUPERIORITY_OR_OTHER|||||||0.18|||||||Fisher Exact|||Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.18
71697855|NCT01125930|142911472|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
71697856|NCT01125930|142911472|SUPERIORITY_OR_OTHER|||||||0.7|||||||Fisher Exact|||Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.70
71697857|NCT01125930|142911472|SUPERIORITY_OR_OTHER|||||||0.35|||||||Fisher Exact|||Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.||||0.35
71697858|NCT01125930|142911473|SUPERIORITY_OR_OTHER|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.80
71697859|NCT01125930|142911473|SUPERIORITY_OR_OTHER|||||||0.31|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.31
71697860|NCT01125930|142911473|SUPERIORITY_OR_OTHER|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.25
71697861|NCT01125930|142911473|SUPERIORITY_OR_OTHER|||||||0.46|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.||||0.46
71697862|NCT01125930|142911474|SUPERIORITY_OR_OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.41
71697863|NCT01125930|142911474|SUPERIORITY_OR_OTHER|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.05
71697864|NCT01125930|142911474|SUPERIORITY_OR_OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.16
71697865|NCT01125930|142911474|SUPERIORITY_OR_OTHER|||||||0.14|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.||||0.14
71697866|NCT01125930|142911475|SUPERIORITY_OR_OTHER|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.36
71697867|NCT01125930|142911475|SUPERIORITY_OR_OTHER|||||||0.88|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.88
71697868|NCT01125930|142911475|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.18
71697869|NCT01125930|142911475|SUPERIORITY_OR_OTHER|||||||0.17|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.||||0.17
71697870|NCT01125930|142911476|SUPERIORITY_OR_OTHER|||||||0.21|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.21
71697871|NCT01125930|142911476|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||<0.01
71697872|NCT01125930|142911476|SUPERIORITY_OR_OTHER|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.04
71697873|NCT01125930|142911476|SUPERIORITY_OR_OTHER|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.||||0.10
71697874|NCT01125930|142911477|SUPERIORITY_OR_OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||1.00
71697875|NCT01125930|142911477|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.02
71697876|NCT01125930|142911477|SUPERIORITY_OR_OTHER|||||||0.08|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.08
71697877|NCT01125930|142911477|SUPERIORITY_OR_OTHER|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.||||0.15
71697878|NCT01125930|142911478|SUPERIORITY_OR_OTHER|||||||0.67|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.67
71697879|NCT01125930|142911478|SUPERIORITY_OR_OTHER|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.18
71697880|NCT01125930|142911478|SUPERIORITY_OR_OTHER|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.02
71697881|NCT01125930|142911478|SUPERIORITY_OR_OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.||||0.42
71697882|NCT03098979|142911501|SUPERIORITY|||||||0.5183||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques.||||||0.5183
71697883|NCT03098979|142911501|SUPERIORITY|||||||0.33||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.3300
71697884|NCT03098979|142911501|SUPERIORITY|||||||0.6232||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.6232
71697885|NCT03098979|142911501|SUPERIORITY|||||||0.0918||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.0918
71697886|NCT03098979|142911501|SUPERIORITY|||||||0.2701||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques||||||0.2701
71697887|NCT02369653|142911510|SUPERIORITY|||||||0.0403|||||||Cochran-Mantel-Haenszel|||||||0.0403
71697888|NCT02369653|142911511|SUPERIORITY|||||||1|||||||Cochran-Mantel-Haenszel|||||||1.0000
71697889|NCT04459338|142911544|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||All continuous data are summarized as means ± SEM. Area Under the Curve (AUC) was calculated using the trapezoidal rule. A paired, two-way Student t-test (parametric) or a Wilcoxon matched-pairs signed rank test (non-parametric) was used to examine differences between study days. A p-value \<0.05 was considered statistically significant.||||0.02
71697890|NCT03720119|142911561|OTHER|Analysis of Variance for repeated measurements.|day effect F|27.83||||0.0001|TWO_SIDED|||||The calculated P-Value represents the repeated measurement/Day (all times versus Day 1)|Dunnett's post-hoc test|||||||0.0001
71697891|NCT03743194|142911563|SUPERIORITY||Geometric mean ratio|0.98||||0.75|TWO_SIDED|95.0|0.85|1.13|||Linear mixed model|||A mixed effects linear model with repeated measures assuming an auto-regressive correlation structure was used to estimate the ratio of geometric means (treatment vs control). One patient from the control group whose measurements were all missing was conservatively imputed to have total OBAS of 2, 1, and 0 at postoperative Days 1, 2, and 3, respectively, assuming the best observed outcome for any control patient at that time. Total OBAS score was log transformed.||1.13|0.85|0.75
71697892|NCT03743194|142911563|SUPERIORITY||Geometric mean ratio|0.97||||0.71|TWO_SIDED|95.0|0.83|1.14|||linear mixed model|||A complete-case analysis (assumed that one patient was missing at random) was conducted as a sensitivity analysis. The ratio of geometric means (treatment vs control) was estimated using a mixed effects linear model with repeated measures assuming an auto-regressive AR(1) correlation structure.||1.14|0.83|0.71
71697893|NCT03743194|142911563|SUPERIORITY||Median Difference (Final Values)|0.08||||0.69|TWO_SIDED|95.0|-0.5|0.67|||Wilcoxon (Mann-Whitney)|||The total OBAS was averaged over 3 postoperative days for the sensitivity analysis. A Wilcoxon rank-sum test with Hodges-Lehmann estimation was used to estimate the median of differences (each OBAS in the treatment group was compared with each OBAS in the control group to calculate the difference)||0.67|-0.5|0.69
71697894|NCT03743194|142911564|SUPERIORITY|The ratio of geometric means was estimated through a generalized linear model with log transformed cumulative opioid consumption as the outcome and treatment group as the exposure. A multiple testing adjustment was applied (0.05/4 = 0.0125), thus 98.75% CI was provided.|Geometric mean ratio|1.01||||0.94|TWO_SIDED|98.75|0.73|1.4|||Regression, Linear|||||1.40|0.73|0.94
71697895|NCT03743194|142911565|SUPERIORITY|Difference in means at POD1|Mean Difference (Final Values)|0.08||||0.36|TWO_SIDED|99.6|-0.17|0.32|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.32|-0.17|0.36
71697896|NCT03743194|142911565|SUPERIORITY|Difference in mean at POD2|Mean Difference (Final Values)|-0.02||||0.79|TWO_SIDED|99.6|-0.26|0.22|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.22|-0.26|0.79
71697897|NCT03743194|142911565|SUPERIORITY|Difference in mean at POD3|Mean Difference (Final Values)|-0.07||||0.39|TWO_SIDED|99.6|-0.31|0.17|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.17|-0.31|0.39
71697898|NCT03743194|142911566|SUPERIORITY|Difference in mean in POD1|Mean Difference (Final Values)|0.07||||0.51|TWO_SIDED|99.6|-0.25|0.4|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.4|-0.25|0.51
71697899|NCT03743194|142911566|SUPERIORITY||Mean Difference (Final Values)|-0.01||||0.91|TWO_SIDED|99.6|-0.33|0.3||Mean difference at POD2|Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.30|-0.33|0.91
71697900|NCT03743194|142911566|SUPERIORITY|Difference in mean at POD3|Mean Difference (Final Values)|-0.11||||0.31|TWO_SIDED|99.6|-0.43|0.21|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.21|-0.43|0.31
71697901|NCT03743194|142911567|SUPERIORITY|Difference in means at POD1|Mean Difference (Final Values)|0.22||||0.36|TWO_SIDED|99.6|-0.47|0.91|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.91|-0.47|0.36
71697902|NCT03743194|142911567|SUPERIORITY||Mean Difference (Final Values)|0.01||||0.97|TWO_SIDED|99.6|-0.66|0.67|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.67|-0.66|0.97
71697903|NCT03743194|142911567|SUPERIORITY|Difference in means at POD3|Mean Difference (Final Values)|-0.21||||0.36|TWO_SIDED|99.6|-0.88|0.46|||Linear mixed model|||The difference in means was estimated through a mixed effects linear model with repeated measures assuming an auto-regressive correlation structure. Treatment effect was reported each day separately due to significant time-treatment interaction.||0.46|-0.88|0.36
71697904|NCT01944423|142911568|SUPERIORITY||Logit difference (final values)|0.64|STANDARD_ERROR_OF_MEAN|0.82|||TWO_SIDED|95.0|-2.25|0.97||p=ns 2-sided|two-phase growth curve model|||||0.97|-2.25|
71697905|NCT01944423|142911569|SUPERIORITY||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|1.87||0.038|TWO_SIDED|95.0|0.25|7.94||2-sided|two-phase growth curve model|||At end-of-treatment||7.94|0.25|.038
71697906|NCT01944423|142911570|SUPERIORITY||Mean Difference (Final Values)|3.21|STANDARD_ERROR_OF_MEAN|1.0||0.003|TWO_SIDED|95.0|1.15|5.26||2-sided|two-phase growth curve model|||At 6 month follow-up||5.26|1.15|.003
71697907|NCT01829347|142911577|SUPERIORITY||Hazard Ratio (HR)|0.31||||0.076|TWO_SIDED|95.0|0.085|1.133|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-Treat (ITT) population utilizing a log-rank test.||1.133|0.085|0.076
71697908|NCT01829347|142911578|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.000
71697909|NCT01259245|142911628|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.017||||0.252|TWO_SIDED|95.0|-0.046|0.012||Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education|ANCOVA|||||0.012|-0.046|0.252
71697910|NCT01259245|142911629|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.005|STANDARD_DEVIATION|0.442||0.984|TWO_SIDED|95.0|-0.438|0.447|||ANCOVA|Adjusted for baseline values, age, sex, education, BMI and smoking||power0.80 for a medium effect size at 5% level of significance||0.447|-0.438|0.984
71697911|NCT01259245|142911630|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.372|STANDARD_DEVIATION|4.433||0.869|TWO_SIDED|95.0|-4.061|4.805|||ANCOVA|adjusted for baseline values, age, sex, education, BMI and education||power of 0.80 for a medium effect size at 5% level of significance||4.805|-4.061|0.869
71697912|NCT01259245|142911631|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.295|STANDARD_DEVIATION|4.706||0.588|TWO_SIDED|95.0|-6.001|3.411|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium size effect at 5% level of significance||3.411|-6.001|0.588
71697913|NCT01259245|142911632|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.15|STANDARD_DEVIATION|4.477||0.345|TWO_SIDED|95.0|-6.627|2.327|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.327|-6.627|0.345
71697914|NCT01259245|142911633|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|4.062||0.413|TWO_SIDED|95.0|-5.753|2.372|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||2.372|-5.753|0.413
71697915|NCT01259245|142911634|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.049|STANDARD_DEVIATION|8.89||0.004|TWO_SIDED|95.0|4.159|21.939|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||21.939|4.159|0.004
71697916|NCT01259245|142911635|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.042|STANDARD_DEVIATION|0.226||0.56|TWO_SIDED|95.0|-0.1|0.184|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.184|-0.100|0.560
71697917|NCT01259245|142911636|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.037|STANDARD_DEVIATION|0.088||0.425|TWO_SIDED|95.0|-0.054|0.128|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||0.128|-0.054|0.425
71697918|NCT01259245|142911637|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.6|STANDARD_DEVIATION|5.2||0.528|TWO_SIDED|95.0|-3.5|6.8|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance||6.8|-3.5|0.528
71697919|NCT00447083|142911647|OTHER|||||||0.1811|||||||t-test, 2 sided|||||||.1811
71697920|NCT03558516|142911664|SUPERIORITY|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||||||0.315
71697921|NCT03558516|142911665|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||||||0.270
71697922|NCT03558516|142911666|SUPERIORITY|||||||0.299|||||||Wilcoxon (Mann-Whitney)|||||||0.299
71697923|NCT03363906|142911671|SUPERIORITY||Ratio Geometric Least Squares (LS) Mean|1.04||||0.473|TWO_SIDED|90.0|0.949|1.14|||Mixed Models Analysis|||||1.14|0.949|0.473
71697924|NCT03363906|142911672|SUPERIORITY||Mean Difference (Final Values)|1.14||||0.119|TWO_SIDED|90.0|0.993|1.3|||ANOVA|||||1.30|0.993|0.119
71697925|NCT00676143|142911673|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02||||0.979|TWO_SIDED|95.0|-1.18|1.22||Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||1.22|-1.18|0.979
71697926|NCT00676143|142911674|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04||||0.973|TWO_SIDED|95.0|-2.51|2.6||Primary variable DAD total score had to reach statistical significance, p-values had to reach p \<=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."||2.60|-2.51|0.973
71697927|NCT00676143|142911675|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.07||||0.159|TWO_SIDED|95.0|-0.17|0.03|||Mixed Models Analysis|||"Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||0.03|-0.17|0.159
71697928|NCT00676143|142911676|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.38||||0.62|TWO_SIDED|95.0|-6.89|4.13|||ANCOVA|||Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.||4.13|-6.89|0.620
71697929|NCT00676143|142911677|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.13||||0.884|TWO_SIDED|95.0|-1.89|1.63|||Mixed Models Analysis|||"Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."||1.63|-1.89|0.884
71697930|NCT00676143|142911678|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.24||||0.7|TWO_SIDED|95.0|-0.97|1.45|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||1.45|-0.97|0.700
71697931|NCT00676143|142911679|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.09||||0.949|TWO_SIDED|95.0|-2.61|2.78|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo||2.78|-2.61|0.949
71697932|NCT00676143|142911680|SUPERIORITY_OR_OTHER|||||||0.684|||||||Log Rank|||||||0.684
71697933|NCT00676143|142911681|SUPERIORITY_OR_OTHER|||||||0.383|||||||Log Rank|||||||0.383
71697934|NCT00676143|142911682|SUPERIORITY_OR_OTHER|||||||0.191|||||||Log Rank|||||||0.191
71697935|NCT00676143|142911683|SUPERIORITY_OR_OTHER|||||||0.478|||||||Log Rank|||||||0.478
71697936|NCT00676143|142911684|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.11||||0.462|TWO_SIDED|95.0|-0.41|0.13|||Mixed Models Analysis|||Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.13|-0.41|0.462
71697937|NCT00676143|142911686|SUPERIORITY_OR_OTHER|||||||0.086|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.086
71697938|NCT00676143|142911688|SUPERIORITY_OR_OTHER|||||||0.12|TWO_SIDED||||||Cochran-Mantel-Haenszel|||||||0.120
71697939|NCT00676143|142911689|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15||||0.448|TWO_SIDED|95.0|-0.55|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.||0.24|-0.55|0.448
71697940|NCT02065557|142911711|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71697941|NCT02065557|142911711|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71697942|NCT02065557|142911711|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.382
71697943|NCT02065557|142911711|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71697944|NCT02065557|142911711|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||< 0.001
71697945|NCT02065557|142911711|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.||||0.344
71697946|NCT02065557|142911712|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697947|NCT02065557|142911712|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697948|NCT02065557|142911712|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
71697949|NCT02065557|142911712|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71761217|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0001|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.||||0.0001
71697950|NCT02065557|142911712|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697951|NCT02065557|142911712|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
71697952|NCT02065557|142911713|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697953|NCT02065557|142911713|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697954|NCT02065557|142911713|SUPERIORITY|one-sample two-sided Chi-square test||||||0.008||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|Chi-squared|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.008
71697955|NCT02065557|142911713|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697956|NCT02065557|142911713|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697957|NCT02065557|142911713|SUPERIORITY|one-sample two-sided Chi-square test||||||0.038||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.038
71697958|NCT02065557|142911714|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697959|NCT02065557|142911714|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697960|NCT02065557|142911714|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
71697961|NCT02065557|142911714|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697962|NCT02065557|142911714|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697963|NCT02065557|142911714|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
71697964|NCT02065557|142911715|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697965|NCT02065557|142911715|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697966|NCT02065557|142911715|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
71697967|NCT02065557|142911715|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697968|NCT02065557|142911715|SUPERIORITY|one-sample two-sided Chi-square test|||||<|0.001||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||< 0.001
71697969|NCT02065557|142911715|SUPERIORITY|one-sample two-sided Chi-square test||||||0.292||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.292
71697970|NCT02065557|142911716|SUPERIORITY|one-sample two-sided Chi-square test||||||0.382||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.382
71697971|NCT02065557|142911716|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
71697972|NCT02065557|142911716|SUPERIORITY|one-sample two-sided Chi-square test||||||1||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||1.000
71697973|NCT02065557|142911716|SUPERIORITY|one-sample two-sided Chi-square test||||||0.344||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.344
71697974|NCT02065557|142911716|SUPERIORITY|one-sample two-sided Chi-square test||||||0.559||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.559
71697975|NCT02065557|142911716|SUPERIORITY|one-sample two-sided Chi-square test||||||0.815||||||Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)|rejective multiple test procedure|controlling familywise Type I error of 5% in a strong sense||Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.||||0.815
71697976|NCT00250588|142911717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.0||||0.05|TWO_SIDED|95.0|0.63|7.4||Bonferroni adjustment.|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||7.4|0.63|0.05
71697977|NCT00250588|142911717|SUPERIORITY_OR_OTHER||Mean Difference (Net)|3.1||||0.05|TWO_SIDED|95.0|-0.21|6.4||Bonferroni adjustment|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.||6.4|-0.21|0.05
71697978|NCT00250588|142911718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.49||||0.21|TWO_SIDED|95.0|0.18|1.38|||Regression, Logistic|Adjustment for age, race/ethnicity, Spanish language and mother's education||||1.38|0.18|0.21
71697979|NCT00250588|142911718|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.22||||0.85|TWO_SIDED|95.0|0.53|2.83||adjustment for age, race/ethnicity, Spanish language and mother's education|Regression, Logistic|||||2.83|0.53|0.85
71697980|NCT00250588|142911719|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.33||||0.011|TWO_SIDED|95.0|0.13|0.82|||Regression, Logistic|All analyses accounted for repeated measures and included the same terms in the model described previously.||Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.||0.82|0.13|0.011
71697981|NCT02330341|142911738|SUPERIORITY|||||||0.38||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus group||||0.380
71697982|NCT02330341|142911738|SUPERIORITY|||||||0.695|||||||Wilcoxon (Mann-Whitney)|The threshold for statistical significance was p=0.05||Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo group||||0.695
71697983|NCT02330341|142911739|SUPERIORITY|||||||0.11||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus group||||0.110
71697984|NCT02330341|142911739|SUPERIORITY|||||||0.91||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group||||0.910
71697985|NCT02330341|142911740|SUPERIORITY|||||||0.01||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus group||||0.010
71697986|NCT02330341|142911740|SUPERIORITY|||||||0.938||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group||||0.938
71697987|NCT02330341|142911741|SUPERIORITY|||||||0.733||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus group||||0.733
71697988|NCT02330341|142911741|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group||||1.0
71697989|NCT02330341|142911742|SUPERIORITY|||||||0.03||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus group||||0.03
71697990|NCT02330341|142911742|SUPERIORITY|||||||0.9||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group||||0.900
71697991|NCT02330341|142911743|SUPERIORITY|||||||0.519||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus group||||0.519
71697992|NCT02330341|142911743|SUPERIORITY|||||||0.922||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group||||0.922
71697993|NCT02330341|142911744|SUPERIORITY|||||||0.605||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus group||||0.605
71697994|NCT02330341|142911744|SUPERIORITY|||||||0.105||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of weight on placebo group||||0.105
71697995|NCT02330341|142911745|SUPERIORITY|||||||0.687||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus group||||0.687
71697996|NCT02330341|142911745|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group||||0.021
71697997|NCT02330341|142911746|SUPERIORITY|||||||0.339||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus group||||0.339
71697998|NCT02330341|142911746|SUPERIORITY|||||||0.246||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group||||0.246
71697999|NCT02330341|142911747|SUPERIORITY|||||||0.775||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus group||||0.775
71698000|NCT02330341|142911747|SUPERIORITY|||||||0.195||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group||||0.195
71698001|NCT02330341|142911748|SUPERIORITY|||||||0.04||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus group||||0.040
71698002|NCT02330341|142911748|SUPERIORITY|||||||1||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group||||1.000
71698003|NCT02330341|142911749|SUPERIORITY|||||||0.021||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus group||||0.021
71698004|NCT02330341|142911749|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group||||0.080
71698005|NCT02330341|142911750|SUPERIORITY|||||||0.465||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus group||||0.465
71698006|NCT02330341|142911750|SUPERIORITY|||||||0.574||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of AST on placebo group||||0.574
71698007|NCT02330341|142911751|SUPERIORITY|||||||0.48||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus group||||0.480
71698008|NCT02330341|142911751|SUPERIORITY|||||||0.383||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group||||0.383
71698009|NCT02330341|142911752|SUPERIORITY|||||||0.034||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus group||||0.034
71698010|NCT02330341|142911752|SUPERIORITY|||||||0.08||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group||||0.080
71698011|NCT02330341|142911753|SUPERIORITY|||||||0.017||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus group||||0.017
71698012|NCT02330341|142911753|SUPERIORITY|||||||0.082||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group||||0.082
71698013|NCT02330341|142911754|SUPERIORITY|||||||0.17||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus group||||0.170
71698014|NCT02330341|142911754|SUPERIORITY|||||||0.199||||||The threshold for statistical significance was p=0.05|Wilcoxon (Mann-Whitney)|||Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group||||0.199
71698015|NCT00572832|142911775|NON_INFERIORITY_OR_EQUIVALENCE|The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /\[log (RGMC) -δ0\] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.||||||0.025||95.0||||Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,\& 18.|ANOVA|Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||||.025
71698016|NCT01258049|142911776|SUPERIORITY_OR_OTHER||Percentage Difference|54.85|||<|0.005|TWO_SIDED|95.0|42.25|67.45|||Regression, Logistic|||In ART003, the parasite success rate for quinine was 67.7%. On the assumption that the parasite success rate was 70% for quinine in this study and in order to demonstrate that ArTiMist™ is superior to quinine by at least 20% the success rate for ArTiMist™ should be at least 90%. Using these figures, and assuming a power of 80%, an alpha of 0.05 (two sided) and based on an equal allocation to the ArTiMist™ and quinine treatment arms, the number of subjects (n) required on each treatment was 59.||67.45|42.25|<0.005
71698017|NCT01258049|142911777|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-38.97|||<|0.05|TWO_SIDED|95.0|-62.22|-15.72|||ANCOVA|||||-15.72|-62.22|<0.05
71698018|NCT01258049|142911778|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.91|||<|0.005|TWO_SIDED|95.0|-17.38|-8.44|||ANCOVA|||||-8.44|-17.38|<0.005
71698019|NCT01258049|142911779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.16|||<|0.005|TWO_SIDED|95.0|-11.71||||Regression, Cox|||||- 6.61|-11.71|<0.005
71698020|NCT01258049|142911780|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|54.02|||<|0.005|TWO_SIDED|95.0|27.05|80.98|||ANCOVA|||||80.98|27.05|<0.005
71698021|NCT01258049|142911781|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|174.09||||0.06|TWO_SIDED|95.0|-10.44|358.61|||ANCOVA||mean parasite counts increased in the first 12 hours for patients on quinine treatment|||358.61|-10.44|0.06
71698022|NCT01258049|142911782|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96||||0.86|TWO_SIDED|95.0|-10.16|12.08|||Regression, Cox|||||12.08|-10.16|0.86
71698023|NCT01258049|142911783|SUPERIORITY_OR_OTHER||Percentage Difference|0.99||||0.99|TWO_SIDED|95.0|0.42|2.36|||Regression, Logistic|||||2.36|0.42|0.99
71698024|NCT01258049|142911786|SUPERIORITY_OR_OTHER||Percentage Difference|55.01|||<|0.005|TWO_SIDED|95.0|42.44|67.58|||Regression, Linear|||||67.58|42.44|<0.005
71698025|NCT03704064|142911813|SUPERIORITY||Mean Difference (Net)|-1.97|STANDARD_ERROR_OF_MEAN|1.32||0.14|TWO_SIDED||||||Mixed Models Analysis|||||||0.14
71698026|NCT03704064|142911814|SUPERIORITY||Odds Ratio (OR)|1.1||||0.89|TWO_SIDED|95.0|0.4|3.4|||Mixed Models Analysis|||||3.4|0.4|0.89
71698027|NCT03704064|142911815|SUPERIORITY||Odds Ratio (OR)|3.7||||0.06|TWO_SIDED|95.0|1.0|14.7|||Mixed Models Analysis|||||14.7|1.0|0.06
71698028|NCT03704064|142911816|SUPERIORITY||Mean Difference (Net)|-2.4|STANDARD_ERROR_OF_MEAN|1.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||||||0.07
71698029|NCT03704064|142911817|SUPERIORITY||Mean Difference (Net)|-1.1|STANDARD_ERROR_OF_MEAN|1.3||0.42|TWO_SIDED||||||Mixed Models Analysis|||||||0.42
71698030|NCT03704064|142911818|SUPERIORITY||Odds Ratio (OR)|2.0||||0.24|TWO_SIDED|95.0|0.6|6.3|||Mixed Models Analysis|||||6.3|0.6|0.24
71698031|NCT03704064|142911819|SUPERIORITY||Odds Ratio (OR)|2.2||||0.24|TWO_SIDED|95.0|0.6|8.1|||Mixed Models Analysis|||||8.1|0.6|0.24
71698032|NCT03704064|142911820|SUPERIORITY||Odds Ratio (OR)|3.0||||0.07|TWO_SIDED|95.0|0.9|9.6|||Mixed Models Analysis|||||9.6|0.9|0.07
71698033|NCT03704064|142911821|SUPERIORITY||Odds Ratio (OR)|2.6||||0.21|TWO_SIDED|95.0|0.6|11.4|||Mixed Models Analysis|||||11.4|0.6|0.21
71698034|NCT03704064|142911822|SUPERIORITY||Mean Difference (Net)|2.4|STANDARD_ERROR_OF_MEAN|5.8||0.62|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.62
71698035|NCT03704064|142911822|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|4.5||0.92|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.92
71698036|NCT03704064|142911822|SUPERIORITY||Mean Difference (Net)|13.4|STANDARD_ERROR_OF_MEAN|9.6||0.16|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.16
71698037|NCT03704064|142911822|SUPERIORITY||Mean Difference (Net)|15.9|STANDARD_ERROR_OF_MEAN|20.8||0.41|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.41
71698038|NCT03704064|142911823|SUPERIORITY||Mean Difference (Net)|4.1|STANDARD_ERROR_OF_MEAN|6.1||0.46|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.46
71698039|NCT03704064|142911823|SUPERIORITY||Mean Difference (Net)|-0.5|STANDARD_ERROR_OF_MEAN|4.9||0.87|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.87
71698040|NCT03704064|142911823|SUPERIORITY||Mean Difference (Net)|18.5|STANDARD_ERROR_OF_MEAN|10.1||0.07|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.07
71698041|NCT03704064|142911823|SUPERIORITY||Mean Difference (Net)|30.0|STANDARD_ERROR_OF_MEAN|22.5||0.17|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.17
71698042|NCT03704064|142911824|SUPERIORITY||Mean Difference (Net)|2.2|STANDARD_ERROR_OF_MEAN|5.7||0.63|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 10 minute bouts||||0.63
71698043|NCT03704064|142911824|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|3.7||0.72|TWO_SIDED||||||Mixed Models Analysis|||MVPA per day with 20 minute bouts||||0.72
71698044|NCT03704064|142911824|SUPERIORITY||Mean Difference (Net)|6.0|STANDARD_ERROR_OF_MEAN|9.4||0.52|TWO_SIDED||||||Mixed Models Analysis|||Moderate activity per day||||0.52
71698045|NCT03704064|142911824|SUPERIORITY||Mean Difference (Net)|-21.8|STANDARD_ERROR_OF_MEAN|19.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||Light activity per day||||0.27
71698046|NCT03704064|142911825|SUPERIORITY||Mean Difference (Net)|7.3|STANDARD_ERROR_OF_MEAN|151.2||0.84|TWO_SIDED||||||Mixed Models Analysis|||||||0.84
71698047|NCT03704064|142911826|SUPERIORITY||Mean Difference (Net)|-111.7|STANDARD_ERROR_OF_MEAN|137.2||0.53|TWO_SIDED||||||Mixed Models Analysis|||||||0.53
71698048|NCT03704064|142911827|SUPERIORITY||Mean Difference (Net)|163.2|STANDARD_ERROR_OF_MEAN|154.0||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
71698049|NCT03704064|142911828|SUPERIORITY||Mean Difference (Net)|5.7|STANDARD_ERROR_OF_MEAN|4.6||0.22|TWO_SIDED||||||Mixed Models Analysis|||||||0.22
71698050|NCT03704064|142911829|SUPERIORITY||Mean Difference (Net)|5.3|STANDARD_ERROR_OF_MEAN|4.6||0.24|TWO_SIDED||||||Mixed Models Analysis|||||||0.24
71698051|NCT03704064|142911830|SUPERIORITY||Mean Difference (Net)|3.2|STANDARD_ERROR_OF_MEAN|4.5||0.48|TWO_SIDED||||||Mixed Models Analysis|||||||0.48
71698052|NCT03704064|142911831|SUPERIORITY||Mean Difference (Net)|4.9|STANDARD_ERROR_OF_MEAN|3.4||0.16|TWO_SIDED||||||Mixed Models Analysis|||||||0.16
71698053|NCT03704064|142911832|SUPERIORITY||Mean Difference (Net)|6.8|STANDARD_ERROR_OF_MEAN|3.4||0.045|TWO_SIDED||||||Mixed Models Analysis|||||||0.045
71698054|NCT03704064|142911833|SUPERIORITY||Mean Difference (Net)|3.7|STANDARD_ERROR_OF_MEAN|3.4||0.27|TWO_SIDED||||||Mixed Models Analysis|||||||0.27
71698055|NCT03704064|142911834|SUPERIORITY||Mean Difference (Net)|3.9|STANDARD_ERROR_OF_MEAN|9.4||0.72|TWO_SIDED||||||Mixed Models Analysis|||||||0.72
71698056|NCT03704064|142911835|SUPERIORITY||Mean Difference (Net)|-3.3|STANDARD_ERROR_OF_MEAN|9.1||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71698057|NCT03704064|142911836|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|2.5||0.8|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.80
71698058|NCT03704064|142911836|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.1||0.94|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.94
71698059|NCT03704064|142911837|SUPERIORITY||Mean Difference (Net)|-4.3|STANDARD_ERROR_OF_MEAN|2.3||0.07|TWO_SIDED||||||Mixed Models Analysis|||Systolic Blood Pressure||||0.07
71698060|NCT03704064|142911837|SUPERIORITY||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|1.5||0.96|TWO_SIDED||||||Mixed Models Analysis|||Diastolic Blood Pressure||||0.96
71698061|NCT03704064|142911838|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3|TWO_SIDED||||||Mixed Models Analysis|||||||0.30
71698062|NCT03704064|142911839|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.2||0.67|TWO_SIDED||||||Mixed Models Analysis|||||||0.67
71698063|NCT03704064|142911840|SUPERIORITY||Mean Difference (Net)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.45|TWO_SIDED||||||Mixed Models Analysis|||||||0.45
71698064|NCT03704064|142911841|SUPERIORITY||Odds Ratio (OR)|1.7||||0.38|TWO_SIDED|95.0|0.5|5.9|||Mixed Models Analysis|||||5.9|0.5|0.38
71698065|NCT03704064|142911842|SUPERIORITY||Odds Ratio (OR)|1.0||||0.95|TWO_SIDED|95.0|0.3|3.3|||Mixed Models Analysis|||||3.3|0.3|0.95
71698066|NCT03704064|142911843|SUPERIORITY||Odds Ratio (OR)|1.0||||0.99|TWO_SIDED|95.0|0.3|3.1|||Mixed Models Analysis|||||3.1|0.3|0.99
71698067|NCT03704064|142911844|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.6||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.06
71698068|NCT03704064|142911844|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.06|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.06
71698069|NCT03704064|142911844|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.19|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.19
71698070|NCT03704064|142911845|SUPERIORITY||Mean Difference (Net)|-3.0|STANDARD_ERROR_OF_MEAN|1.5||0.05|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.05
71698071|NCT03704064|142911845|SUPERIORITY||Mean Difference (Net)|-1.2|STANDARD_ERROR_OF_MEAN|0.9||0.18|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.18
71698072|NCT03704064|142911845|SUPERIORITY||Mean Difference (Net)|-1.8|STANDARD_ERROR_OF_MEAN|0.9||0.046|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.046
71698073|NCT03704064|142911846|SUPERIORITY||Mean Difference (Net)|-2.7|STANDARD_ERROR_OF_MEAN|1.5||0.07|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-Total||||0.07
71698074|NCT03704064|142911846|SUPERIORITY||Mean Difference (Net)|-1.5|STANDARD_ERROR_OF_MEAN|0.9||0.11|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-SD||||0.11
71698075|NCT03704064|142911846|SUPERIORITY||Mean Difference (Net)|-1.3|STANDARD_ERROR_OF_MEAN|0.9||0.15|TWO_SIDED||||||Mixed Models Analysis|||WSSQ-FE||||0.15
71698076|NCT03704064|142911847|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.3||0.04|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.04
71698077|NCT03704064|142911847|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.35|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.35
71698078|NCT03704064|142911847|SUPERIORITY||Mean Difference (Net)|1.5|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
71698079|NCT03704064|142911847|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.01|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.01
71698080|NCT03704064|142911847|SUPERIORITY||Mean Difference (Net)|1.0|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||<0.001
71698081|NCT03704064|142911847|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|0.2|<|0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||<0.001
71698082|NCT03704064|142911848|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.24|TWO_SIDED||||||ANOVA|||Overall treatment acceptability||||0.24
71698083|NCT03704064|142911848|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.28|TWO_SIDED||||||ANOVA|||BWL component acceptability||||0.28
71698084|NCT03704064|142911848|SUPERIORITY||Mean Difference (Net)|1.8|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED||||||ANOVA|||BIAS vs recipe component acceptability||||<0.001
71698085|NCT03704064|142911848|SUPERIORITY||Mean Difference (Net)|0.3|STANDARD_ERROR_OF_MEAN|0.3||0.34|TWO_SIDED||||||ANOVA|||BWL skill acquisition||||0.34
71698086|NCT03704064|142911848|SUPERIORITY||Mean Difference (Net)|0.8|STANDARD_ERROR_OF_MEAN|0.3||0.008|TWO_SIDED||||||ANOVA|||Stigma-related skill acquisition||||0.008
71698087|NCT03704064|142911848|SUPERIORITY||Mean Difference (Net)|0.6|STANDARD_ERROR_OF_MEAN|0.2||0.001|TWO_SIDED||||||ANOVA|||Stigma-related skill use||||0.001
71698088|NCT02783911|142911889|SUPERIORITY|||||||0.808|||||||Chi-squared|||||||0.808
71698089|NCT01041859|142911891|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.234|<|0.001|TWO_SIDED|95.0|-1.415|-0.493||Analysis of covariance (ANCOVA) model was used with treatment, dose level, and pooled analysis center as factors and baseline pain intensity score as a covariate|ANCOVA||Mean Difference is least squares mean change in DB Tapentadol ER group minus least squares mean change in DB Placebo group (based on ANCOVA model)|The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 1.0 with an SD of 2.6, 144 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a DB treatment group for the study was 300.||-0.493|-1.415|<0.001
71698090|NCT02908347|142911915|SUPERIORITY||Median Difference (Final Values)|0.64||||0.8785|TWO_SIDED|95.0|-2.09|3.36|||Wilcoxon (Mann-Whitney)|||||3.36|-2.09|0.8785
71698091|NCT02908347|142911918|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 30 - Day 29||||1
71698092|NCT02908347|142911918|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 29||||1
71698093|NCT02908347|142911918|SUPERIORITY|||||||0.5136|||||||Fisher Exact|||PASI 30 - Day 43||||0.5136
71698094|NCT02908347|142911918|SUPERIORITY|||||||1|||||||Fisher Exact|||PASI 50 - Day 43||||1
71698095|NCT00885118|142911926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|42828.482|STANDARD_ERROR_OF_MEAN|6487.174|<|0.0001|TWO_SIDED|95.0|29936.586|55720.378|||ANCOVA|The baseline value was included as a continuous covariate.||Difference calculated as empa 1mg minus placebo||55720.378|29936.586|<0.0001
71698096|NCT00885118|142911926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|80964.677|STANDARD_ERROR_OF_MEAN|6303.82|<|0.0001|TWO_SIDED|95.0|68437.16|93492.194|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||93492.194|68437.160|<0.0001
71698097|NCT00885118|142911926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|88589.764|STANDARD_ERROR_OF_MEAN|6544.604|<|0.0001|TWO_SIDED|95.0|75583.738|101595.79|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||101595.790|75583.738|<0.0001
71698098|NCT00885118|142911926|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|85620.348|STANDARD_ERROR_OF_MEAN|6610.091|<|0.0001|TWO_SIDED|95.0|72484.181|98756.515|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||98756.515|72484.181|<0.0001
71698099|NCT00885118|142911927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_ERROR_OF_MEAN|4.155||0.003|TWO_SIDED|95.0|-20.936|-4.424|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-4.424|-20.936|0.0030
71698100|NCT00885118|142911927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.92|STANDARD_ERROR_OF_MEAN|4.025|<|0.0001|TWO_SIDED|95.0|-27.919|-11.921|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.921|-27.919|<0.0001
71698101|NCT00885118|142911927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.208|STANDARD_ERROR_OF_MEAN|4.168|<|0.0001|TWO_SIDED|95.0|-34.49|-17.925|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-17.925|-34.490|<0.0001
71698102|NCT00885118|142911927|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.235|STANDARD_ERROR_OF_MEAN|4.202|<|0.0001|TWO_SIDED|95.0|-35.586|-18.884|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-18.884|-35.586|<0.0001
71698103|NCT00885118|142911928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.883|STANDARD_ERROR_OF_MEAN|5.861||0.003|TWO_SIDED|95.0|-29.529|-6.236|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-6.236|-29.529|0.0030
71698104|NCT00885118|142911928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-22.487|STANDARD_ERROR_OF_MEAN|5.445|<|0.0001|TWO_SIDED|95.0|-33.308|-11.665|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-11.665|-33.308|<0.0001
71698105|NCT00885118|142911928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-26.265|STANDARD_ERROR_OF_MEAN|5.785|<|0.0001|TWO_SIDED|95.0|-37.762|-14.768|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-14.768|-37.762|<0.0001
71698106|NCT00885118|142911928|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.34|STANDARD_ERROR_OF_MEAN|5.699|<|0.0001|TWO_SIDED|95.0|-39.665|-17.015|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-17.015|-39.665|<0.0001
71698107|NCT00885118|142911929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.239|STANDARD_ERROR_OF_MEAN|0.13||0.0705|TWO_SIDED|95.0|-0.498|-0.02|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.020|-0.498|0.0705
71698108|NCT00885118|142911929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.296|STANDARD_ERROR_OF_MEAN|0.125||0.0203|TWO_SIDED|95.0|-0.545|-0.047|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-0.047|-0.545|0.0203
71698109|NCT00885118|142911929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.429|STANDARD_ERROR_OF_MEAN|0.13||0.0014|TWO_SIDED|95.0|-0.687|-0.17|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.170|-0.687|0.0014
71698110|NCT00885118|142911929|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.395|STANDARD_ERROR_OF_MEAN|0.131||0.0033|TWO_SIDED|95.0|-0.654|-0.135|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.135|-0.654|0.0033
71698111|NCT00885118|142911930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.527|STANDARD_ERROR_OF_MEAN|17.755||0.4823|TWO_SIDED|95.0|-22.757|47.811|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||47.811|-22.757|0.4823
71698112|NCT00885118|142911930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.984|STANDARD_ERROR_OF_MEAN|17.313||0.7305|TWO_SIDED|95.0|-28.422|40.39|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||40.390|-28.422|0.7305
71698113|NCT00885118|142911930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.858|STANDARD_ERROR_OF_MEAN|17.903||0.3213|TWO_SIDED|95.0|-53.438|17.721|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||17.721|-53.438|0.3213
71698114|NCT00885118|142911930|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-19.838|STANDARD_ERROR_OF_MEAN|18.13||0.2768|TWO_SIDED|95.0|-55.869|16.192|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||16.192|-55.869|0.2768
71698115|NCT00885118|142911931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.192|STANDARD_ERROR_OF_MEAN|0.728|<|0.0001|TWO_SIDED|95.0|-5.653|-2.731|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-2.731|-5.653|<0.0001
71698116|NCT00885118|142911931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.609|STANDARD_ERROR_OF_MEAN|0.756|<|0.0001||95.0|-6.126|-3.091|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-3.091|-6.126|<0.0001
71698117|NCT00885118|142911931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.036|STANDARD_ERROR_OF_MEAN|0.762|<|0.0001|TWO_SIDED|95.0|-5.565|-2.508|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-2.508|-5.565|<0.0001
71698118|NCT00885118|142911931|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.887|STANDARD_ERROR_OF_MEAN|1.076|<|0.0001|TWO_SIDED|95.0|-7.048|-2.726|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-2.726|-7.048|<0.0001
71698119|NCT00885118|142911932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.414||0.2498|TWO_SIDED|95.0|-1.302|0.343|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||0.343|-1.302|0.2498
71698120|NCT00885118|142911932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.379|STANDARD_ERROR_OF_MEAN|0.408||0.3544|TWO_SIDED|95.0|-1.189|0.43|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||0.430|-1.189|0.3544
71698121|NCT00885118|142911932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.343|STANDARD_ERROR_OF_MEAN|0.416||0.0018|TWO_SIDED|95.0|-2.171|-0.516|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-0.516|-2.171|0.0018
71698122|NCT00885118|142911932|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.257|STANDARD_ERROR_OF_MEAN|0.421||0.0037|TWO_SIDED|95.0|-2.094|-0.419|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-0.419|-2.094|0.0037
71698123|NCT00885118|142911933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-95.414|STANDARD_ERROR_OF_MEAN|15.388|<|0.0001|TWO_SIDED|95.0|-125.995|-64.833|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-64.833|-125.995|<0.0001
71698124|NCT00885118|142911933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-109.48|STANDARD_ERROR_OF_MEAN|14.67|<|0.0001|TWO_SIDED|95.0|-138.633|-80.327|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-80.327|-138.633|<0.0001
71698125|NCT00885118|142911933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-131.336|STANDARD_ERROR_OF_MEAN|15.354|<|0.0001|TWO_SIDED|95.0|-161.848|-100.824|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-100.824|-161.848|<0.0001
71698126|NCT00885118|142911933|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-136.341|STANDARD_ERROR_OF_MEAN|15.357|<|0.0001|TWO_SIDED|95.0|-166.86|-105.823|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-105.823|-166.860|<0.0001
71698127|NCT00885118|142911934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.668|STANDARD_ERROR_OF_MEAN|13.152||0.0883|TWO_SIDED|95.0|-3.47|48.805|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||48.805|-3.470|0.0883
71698128|NCT00885118|142911934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.576|STANDARD_ERROR_OF_MEAN|12.941||0.0203|TWO_SIDED|95.0|4.859|56.293|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||56.293|4.859|0.0203
71698129|NCT00885118|142911934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.974|STANDARD_ERROR_OF_MEAN|13.289||0.6541|TWO_SIDED|95.0|-20.434|32.382|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||32.382|-20.434|0.6541
71698130|NCT00885118|142911934|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.015|STANDARD_ERROR_OF_MEAN|13.612||0.4206|TWO_SIDED|95.0|-16.036|38.066|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||38.066|-16.036|0.4206
71698131|NCT00885118|142911935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.869|STANDARD_ERROR_OF_MEAN|4.066||0.0318|TWO_SIDED|95.0|-16.949|-0.789|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo||-0.789|-16.949|0.0318
71698132|NCT00885118|142911935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.344|STANDARD_ERROR_OF_MEAN|3.966||0.0005|TWO_SIDED|95.0|-22.225|-6.462|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo||-6.462|-22.225|0.0005
71698133|NCT00885118|142911935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.642|STANDARD_ERROR_OF_MEAN|4.131||0.0003|TWO_SIDED|95.0|-23.853|-7.432|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo||-7.432|-23.853|0.0003
71698134|NCT00885118|142911935|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.118|STANDARD_ERROR_OF_MEAN|4.137||0.0164|TWO_SIDED|95.0|-18.339|-1.897|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo||-1.897|-18.339|0.0164
71698135|NCT03082729|142911973|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
71698136|NCT03082729|142911974|SUPERIORITY|||||||0.083|||||||t-test, 2 sided|||||||0.083
71698137|NCT03082729|142911975|SUPERIORITY|||||||0.617|||||||t-test, 2 sided|||||||0.617
71698138|NCT03082729|142911976|SUPERIORITY|||||||0.524|||||||t-test, 2 sided|||||||0.524
71698139|NCT03082729|142911977|SUPERIORITY|||||||0.972|||||||t-test, 2 sided|||||||0.972
71698140|NCT03082729|142911978|SUPERIORITY|||||||0.315|||||||t-test, 2 sided|||||||0.315
71698141|NCT03082729|142911979|SUPERIORITY|||||||0.443|||||||t-test, 2 sided|||||||0.443
71698142|NCT03082729|142911980|SUPERIORITY|||||||0.027|||||||t-test, 2 sided|||||||0.027
71698143|NCT03082729|142911981|SUPERIORITY|||||||0.39|||||||t-test, 2 sided|||||||0.390
71698144|NCT03082729|142911982|SUPERIORITY|||||||0.116|||||||t-test, 2 sided|||||||0.116
71698145|NCT03082729|142911983|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
71698146|NCT03082729|142911984|SUPERIORITY|||||||0.225|||||||t-test, 2 sided|||||||0.225
71698147|NCT03082729|142911985|SUPERIORITY|||||||0.141|||||||t-test, 2 sided|||||||0.141
71698148|NCT03082729|142911986|SUPERIORITY|||||||0.882|||||||t-test, 2 sided|||||||0.882
71698149|NCT03082729|142911987|SUPERIORITY|||||||0.326|||||||t-test, 2 sided|||||||0.326
71698150|NCT03082729|142911988|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71698151|NCT03082729|142911989|SUPERIORITY|||||||0.087|||||||t-test, 2 sided|||||||0.087
71698152|NCT03082729|142911990|SUPERIORITY|||||||0.771|||||||t-test, 2 sided|||||||0.771
71698153|NCT03082729|142911991|SUPERIORITY|||||||0.491|||||||t-test, 2 sided|||||||0.491
71698154|NCT03082729|142911992|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||||||0.924
71698155|NCT03082729|142911993|SUPERIORITY|||||||0.868|||||||t-test, 2 sided|||||||0.868
71698156|NCT03082729|142911994|SUPERIORITY|||||||0.922|||||||t-test, 2 sided|||||||0.922
71698157|NCT03082729|142911995|SUPERIORITY|||||||0.192|||||||t-test, 2 sided|||||||0.192
71698158|NCT03082729|142911996|SUPERIORITY|||||||0.453|||||||t-test, 2 sided|||||||0.453
71698159|NCT03082729|142911997|SUPERIORITY|||||||0.714|||||||t-test, 2 sided|||||||0.714
71698160|NCT03082729|142911998|SUPERIORITY|||||||0.434|||||||t-test, 2 sided|||||||0.434
71698161|NCT03082729|142911999|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
71698162|NCT03082729|142912000|SUPERIORITY|||||||0.963|||||||t-test, 2 sided|||||||0.963
71698163|NCT03082729|142912001|SUPERIORITY|||||||0.4|||||||t-test, 2 sided|||||||0.400
71698164|NCT03082729|142912002|SUPERIORITY|||||||0.223|||||||t-test, 2 sided|||||||0.223
71698165|NCT03082729|142912003|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
71698166|NCT03082729|142912004|SUPERIORITY|||||||0.348|||||||t-test, 2 sided|||||||0.348
71698167|NCT03082729|142912005|SUPERIORITY|||||||0.424|||||||t-test, 2 sided|||||||0.424
71698168|NCT03082729|142912006|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
71698169|NCT03082729|142912007|SUPERIORITY|||||||0.135|||||||t-test, 2 sided|||||||0.135
71698170|NCT03082729|142912008|SUPERIORITY|||||||0.331|||||||t-test, 2 sided|||||||0.331
71698171|NCT03082729|142912009|SUPERIORITY|||||||0.538|||||||t-test, 2 sided|||||||0.538
71698172|NCT03082729|142912010|SUPERIORITY|||||||0.791|||||||t-test, 2 sided|||||||0.791
71698173|NCT03082729|142912011|SUPERIORITY|||||||0.925|||||||t-test, 2 sided|||||||0.925
71698174|NCT03082729|142912012|SUPERIORITY|||||||0.161|||||||t-test, 2 sided|||||||0.161
71698175|NCT03082729|142912013|SUPERIORITY|||||||0.546|||||||t-test, 2 sided|||||||0.546
71698176|NCT03082729|142912014|SUPERIORITY|||||||0.667|||||||t-test, 2 sided|||||||0.667
71698177|NCT03082729|142912015|SUPERIORITY|||||||0.84|||||||t-test, 2 sided|||||||0.840
71698178|NCT03082729|142912016|SUPERIORITY|||||||0.367|||||||t-test, 2 sided|||||||0.367
71698179|NCT03082729|142912017|SUPERIORITY|||||||0.773|||||||t-test, 2 sided|||||||0.773
71698180|NCT03082729|142912018|SUPERIORITY|||||||0.968|||||||t-test, 2 sided|||||||0.968
71698181|NCT03082729|142912019|SUPERIORITY|||||||0.953|||||||t-test, 2 sided|||||||0.953
71698182|NCT03082729|142912020|SUPERIORITY|||||||0.911|||||||t-test, 2 sided|||||||0.911
71698183|NCT03082729|142912021|SUPERIORITY|||||||0.944|||||||t-test, 2 sided|||||||0.944
71698184|NCT03082729|142912022|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
71698185|NCT03082729|142912023|SUPERIORITY|||||||0.988|||||||t-test, 2 sided|||||||0.988
71698186|NCT03082729|142912024|SUPERIORITY|||||||0.189|||||||t-test, 2 sided|||||||0.189
71698187|NCT03082729|142912025|SUPERIORITY|||||||0.488|||||||t-test, 2 sided|||||||0.488
71698188|NCT03082729|142912026|SUPERIORITY|||||||0.523|||||||t-test, 2 sided|||||||0.523
71698189|NCT03082729|142912027|SUPERIORITY|||||||0.06|||||||t-test, 2 sided|||||||0.060
71698190|NCT03082729|142912028|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
71698191|NCT03082729|142912029|SUPERIORITY|||||||0.946|||||||t-test, 2 sided|||||||0.946
71698192|NCT03082729|142912030|SUPERIORITY|||||||0.351|||||||t-test, 2 sided|||||||0.351
71698193|NCT03082729|142912031|SUPERIORITY|||||||0.041|||||||t-test, 2 sided|||||||0.041
71698194|NCT03082729|142912032|SUPERIORITY|||||||0.884|||||||t-test, 2 sided|||||||0.884
71698195|NCT03082729|142912033|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
71698196|NCT03082729|142912034|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71698197|NCT03082729|142912035|SUPERIORITY|||||||0.018|||||||t-test, 2 sided|||||||0.018
71698198|NCT03082729|142912036|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
71698199|NCT03082729|142912037|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71698200|NCT03082729|142912038|SUPERIORITY|||||||0.371|||||||t-test, 2 sided|||||||0.371
71698201|NCT03082729|142912039|SUPERIORITY|||||||0.555|||||||t-test, 2 sided|||||||0.555
71698202|NCT03082729|142912040|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
71698203|NCT03082729|142912041|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
71698204|NCT03082729|142912042|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71698205|NCT03082729|142912042|SUPERIORITY|||||||0.015|||||||t-test, 2 sided|||||||0.015
71698206|NCT03082729|142912042|SUPERIORITY|||||||0.537|||||||t-test, 2 sided|||||||0.537
71698207|NCT03082729|142912043|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||||||0.001
71698208|NCT03082729|142912043|SUPERIORITY|||||||0.01|||||||t-test, 2 sided|||||||0.010
71698209|NCT03082729|142912043|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
71698210|NCT03082729|142912044|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698211|NCT03082729|142912044|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698212|NCT03082729|142912045|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698213|NCT03082729|142912045|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698214|NCT03082729|142912046|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698215|NCT03082729|142912046|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698216|NCT03082729|142912047|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<0.001
71698217|NCT03082729|142912047|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71698218|NCT03082729|142912049|SUPERIORITY|||||||0.092|||||||t-test, 2 sided|||||||0.092
71698219|NCT03082729|142912049|SUPERIORITY|||||||0.678|||||||t-test, 2 sided|||||||0.678
71698220|NCT03082729|142912050|SUPERIORITY|||||||0.02|||||||t-test, 2 sided|||||||0.020
71698221|NCT03082729|142912050|SUPERIORITY|||||||0.762|||||||t-test, 2 sided|||||||0.762
71698222|NCT03082729|142912051|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||||||0.973
71698223|NCT03082729|142912051|SUPERIORITY|||||||0.805|||||||t-test, 2 sided|||||||0.805
71698224|NCT03082729|142912052|SUPERIORITY|||||||0.951|||||||t-test, 2 sided|||||||0.951
71698225|NCT03082729|142912052|SUPERIORITY|||||||0.661|||||||t-test, 2 sided|||||||0.661
71698226|NCT03082729|142912053|SUPERIORITY|||||||0.614|||||||t-test, 2 sided|||||||0.614
71698227|NCT03082729|142912053|SUPERIORITY|||||||0.306|||||||t-test, 2 sided|||||||0.306
71698228|NCT03082729|142912054|SUPERIORITY|||||||0.322|||||||t-test, 2 sided|||||||0.322
71698229|NCT03082729|142912054|SUPERIORITY|||||||0.032|||||||t-test, 2 sided|||||||0.032
71698230|NCT03082729|142912055|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
71698231|NCT03082729|142912055|SUPERIORITY|||||||0.268|||||||t-test, 2 sided|||||||0.268
71698232|NCT03082729|142912056|SUPERIORITY|||||||0.501|||||||t-test, 2 sided|||||||0.501
71698233|NCT03082729|142912056|SUPERIORITY|||||||0.235|||||||t-test, 2 sided|||||||0.235
71698234|NCT03082729|142912057|SUPERIORITY|||||||0.259|||||||t-test, 2 sided|||||||0.259
71698235|NCT03082729|142912057|SUPERIORITY|||||||0.219|||||||t-test, 2 sided|||||||0.219
71698236|NCT03082729|142912058|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||||||0.140
71698237|NCT03082729|142912058|SUPERIORITY|||||||0.633|||||||t-test, 2 sided|||||||0.633
71698238|NCT03082729|142912059|SUPERIORITY|||||||0.302|||||||t-test, 2 sided|||||||0.302
71698239|NCT03082729|142912059|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
71698240|NCT03082729|142912060|SUPERIORITY|||||||0.297|||||||t-test, 2 sided|||||||0.297
71698241|NCT03082729|142912060|SUPERIORITY|||||||0.324|||||||t-test, 2 sided|||||||0.324
71698242|NCT03082729|142912061|SUPERIORITY|||||||0.812|||||||t-test, 2 sided|||||||0.812
71698243|NCT03082729|142912061|SUPERIORITY|||||||0.264|||||||t-test, 2 sided|||||||0.264
71698244|NCT03082729|142912062|SUPERIORITY|||||||0.283|||||||t-test, 2 sided|||||||0.283
71698245|NCT03082729|142912062|SUPERIORITY|||||||0.25|||||||t-test, 2 sided|||||||0.250
71698246|NCT03082729|142912063|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
71698247|NCT03082729|142912063|SUPERIORITY|||||||0.249|||||||t-test, 2 sided|||||||0.249
71698248|NCT03082729|142912064|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
71698249|NCT03082729|142912064|SUPERIORITY|||||||0.632|||||||t-test, 2 sided|||||||0.632
71698250|NCT03082729|142912065|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
71698251|NCT03082729|142912065|SUPERIORITY|||||||0.191|||||||t-test, 2 sided|||||||0.191
71698252|NCT03082729|142912066|SUPERIORITY|||||||0.005|||||||t-test, 2 sided|||||||0.005
71698253|NCT03082729|142912066|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||||||0.004
71698254|NCT03082729|142912067|SUPERIORITY|||||||0.533|||||||t-test, 2 sided|||||||0.533
71698255|NCT03082729|142912067|SUPERIORITY|||||||0.079|||||||t-test, 2 sided|||||||0.079
71698256|NCT03082729|142912068|SUPERIORITY|||||||0.338|||||||t-test, 2 sided|||||||0.338
71698257|NCT03082729|142912068|SUPERIORITY|||||||0.091|||||||t-test, 2 sided|||||||0.091
71698258|NCT03082729|142912069|SUPERIORITY|||||||0.102|||||||t-test, 2 sided|||||||0.102
71698259|NCT03082729|142912069|SUPERIORITY|||||||0.153|||||||t-test, 2 sided|||||||0.153
71698260|NCT03082729|142912070|SUPERIORITY|||||||0.226|||||||t-test, 2 sided|||||||0.226
71698261|NCT03082729|142912070|SUPERIORITY|||||||0.222|||||||t-test, 2 sided|||||||0.222
71698262|NCT03082729|142912071|SUPERIORITY|||||||0.384|||||||t-test, 2 sided|||||||0.384
71698263|NCT03082729|142912071|SUPERIORITY|||||||0.112|||||||t-test, 2 sided|||||||0.112
71698264|NCT03082729|142912072|SUPERIORITY|||||||0.636|||||||t-test, 2 sided|||||||0.636
71698265|NCT03082729|142912072|SUPERIORITY|||||||0.896|||||||t-test, 2 sided|||||||0.896
71698266|NCT03082729|142912073|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||||||0.800
71698267|NCT03082729|142912073|SUPERIORITY|||||||0.551|||||||t-test, 2 sided|||||||0.551
71698268|NCT03082729|142912074|SUPERIORITY|||||||0.44|||||||t-test, 2 sided|||||||0.440
71698269|NCT03082729|142912074|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
71698270|NCT03082729|142912075|SUPERIORITY|||||||0.278|||||||t-test, 2 sided|||||||0.278
71698271|NCT03082729|142912075|SUPERIORITY|||||||0.089|||||||t-test, 2 sided|||||||0.089
71698272|NCT03082729|142912076|SUPERIORITY|||||||0.795|||||||t-test, 2 sided|||||||0.795
71698273|NCT03082729|142912076|SUPERIORITY|||||||0.284|||||||t-test, 2 sided|||||||0.284
71698274|NCT03082729|142912077|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||||||0.880
71698275|NCT03082729|142912077|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
71698276|NCT03082729|142912078|SUPERIORITY|||||||0.746|||||||t-test, 2 sided|||||||0.746
71698277|NCT03082729|142912078|SUPERIORITY|||||||0.199|||||||t-test, 2 sided|||||||0.199
71698278|NCT03082729|142912079|SUPERIORITY|||||||0.814|||||||t-test, 2 sided|||||||0.814
71698279|NCT03082729|142912079|SUPERIORITY|||||||0.036|||||||t-test, 2 sided|||||||0.036
71698280|NCT03082729|142912080|SUPERIORITY|||||||0.494|||||||t-test, 2 sided|||||||0.494
71698281|NCT03082729|142912080|SUPERIORITY|||||||0.96|||||||t-test, 2 sided|||||||0.960
71698282|NCT03082729|142912081|SUPERIORITY|||||||0.777|||||||t-test, 2 sided|||||||0.777
71698283|NCT03082729|142912081|SUPERIORITY|||||||0.028|||||||t-test, 2 sided|||||||0.028
71698284|NCT03082729|142912082|SUPERIORITY|||||||0.241|||||||t-test, 2 sided|||||||0.241
71698285|NCT03082729|142912082|SUPERIORITY|||||||0.869|||||||t-test, 2 sided|||||||0.869
71698286|NCT03082729|142912083|SUPERIORITY|||||||0.977|||||||t-test, 2 sided|||||||0.977
71698287|NCT03082729|142912083|SUPERIORITY|||||||0.012|||||||t-test, 2 sided|||||||0.012
71698288|NCT03082729|142912084|SUPERIORITY|||||||0.591|||||||t-test, 2 sided|||||||0.591
71698289|NCT03082729|142912084|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71698290|NCT03082729|142912085|SUPERIORITY|||||||0.26|||||||t-test, 2 sided|||||||0.260
71698291|NCT03082729|142912085|SUPERIORITY|||||||0.526|||||||t-test, 2 sided|||||||0.526
71698292|NCT03082729|142912086|SUPERIORITY|||||||0.545|||||||t-test, 2 sided|||||||0.545
71698293|NCT03082729|142912086|SUPERIORITY|||||||0.69|||||||t-test, 2 sided|||||||0.690
71698294|NCT03082729|142912087|SUPERIORITY|||||||0.542|||||||t-test, 2 sided|||||||0.542
71698295|NCT03082729|142912087|SUPERIORITY|||||||0.344|||||||t-test, 2 sided|||||||0.344
71698296|NCT03082729|142912088|SUPERIORITY|||||||0.918|||||||t-test, 2 sided|||||||0.918
71698297|NCT03082729|142912088|SUPERIORITY|||||||0.035|||||||t-test, 2 sided|||||||0.035
71698298|NCT03082729|142912089|SUPERIORITY|||||||0.51|||||||t-test, 2 sided|||||||0.510
71698299|NCT03082729|142912089|SUPERIORITY|||||||0.516|||||||t-test, 2 sided|||||||0.516
71698300|NCT03082729|142912090|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71698301|NCT03082729|142912090|SUPERIORITY|||||||0.088|||||||t-test, 2 sided|||||||0.088
71698302|NCT03082729|142912091|SUPERIORITY|||||||0.392|||||||t-test, 2 sided|||||||0.392
71698303|NCT03082729|142912091|SUPERIORITY|||||||0.177|||||||t-test, 2 sided|||||||0.177
71698304|NCT03082729|142912092|SUPERIORITY|||||||0.584|||||||t-test, 2 sided|||||||0.584
71698305|NCT03082729|142912092|SUPERIORITY|||||||0.065|||||||t-test, 2 sided|||||||0.065
71698306|NCT03082729|142912093|SUPERIORITY|||||||0.421|||||||t-test, 2 sided|||||||0.421
71698307|NCT03082729|142912093|SUPERIORITY|||||||0.145|||||||t-test, 2 sided|||||||0.145
71698308|NCT03082729|142912094|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
71698309|NCT03082729|142912094|SUPERIORITY|||||||0.345|||||||t-test, 2 sided|||||||0.345
71698310|NCT03082729|142912095|SUPERIORITY|||||||0.957|||||||t-test, 2 sided|||||||0.957
71698311|NCT03082729|142912095|SUPERIORITY|||||||0.425|||||||t-test, 2 sided|||||||0.425
71698312|NCT03082729|142912096|SUPERIORITY|||||||0.698|||||||t-test, 2 sided|||||||0.698
71698313|NCT03082729|142912096|SUPERIORITY|||||||0.709|||||||t-test, 2 sided|||||||0.709
71698314|NCT03082729|142912097|SUPERIORITY|||||||0.362|||||||t-test, 2 sided|||||||0.362
71698315|NCT03082729|142912097|SUPERIORITY|||||||0.221|||||||t-test, 2 sided|||||||0.221
71698316|NCT03082729|142912098|SUPERIORITY|||||||0.813|||||||t-test, 2 sided|||||||0.813
71698317|NCT03082729|142912098|SUPERIORITY|||||||0.046|||||||t-test, 2 sided|||||||0.046
71698318|NCT03082729|142912099|SUPERIORITY|||||||0.752|||||||t-test, 2 sided|||||||0.752
71698319|NCT03082729|142912099|SUPERIORITY|||||||0.808|||||||t-test, 2 sided|||||||0.808
71698320|NCT03082729|142912100|SUPERIORITY|||||||0.251|||||||t-test, 2 sided|||||||0.251
71698321|NCT03082729|142912100|SUPERIORITY|||||||0.329|||||||t-test, 2 sided|||||||0.329
71698322|NCT03082729|142912101|SUPERIORITY|||||||0.215|||||||t-test, 2 sided|||||||0.215
71698323|NCT03082729|142912101|SUPERIORITY|||||||0.612|||||||t-test, 2 sided|||||||0.612
71698324|NCT03082729|142912102|SUPERIORITY|||||||0.307|||||||t-test, 2 sided|||||||0.307
71698325|NCT03082729|142912102|SUPERIORITY|||||||0.686|||||||t-test, 2 sided|||||||0.686
71698326|NCT03082729|142912103|SUPERIORITY|||||||0.139|||||||t-test, 2 sided|||||||0.139
71698327|NCT03082729|142912103|SUPERIORITY|||||||0.35|||||||t-test, 2 sided|||||||0.350
71698328|NCT03082729|142912104|SUPERIORITY|||||||0.721|||||||t-test, 2 sided|||||||0.721
71698329|NCT03082729|142912104|SUPERIORITY|||||||0.285|||||||t-test, 2 sided|||||||0.285
71698330|NCT03082729|142912105|SUPERIORITY|||||||0.804|||||||t-test, 2 sided|||||||0.804
71698331|NCT03082729|142912105|SUPERIORITY|||||||0.793|||||||t-test, 2 sided|||||||0.793
71698332|NCT03082729|142912106|SUPERIORITY|||||||0.293|||||||t-test, 2 sided|||||||0.293
71698333|NCT03082729|142912106|SUPERIORITY|||||||0.355|||||||t-test, 2 sided|||||||0.355
71698334|NCT03082729|142912107|SUPERIORITY|||||||0.101|||||||t-test, 2 sided|||||||0.101
71698335|NCT03082729|142912107|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||||||0.170
71698336|NCT03082729|142912108|SUPERIORITY|||||||0.137|||||||t-test, 2 sided|||||||0.137
71698337|NCT03082729|142912108|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71698338|NCT03082729|142912109|SUPERIORITY|||||||0.115|||||||t-test, 2 sided|||||||0.115
71698339|NCT03082729|142912109|SUPERIORITY|||||||0.378|||||||t-test, 2 sided|||||||0.378
71698340|NCT03082729|142912110|SUPERIORITY|||||||0.122|||||||t-test, 2 sided|||||||0.122
71698341|NCT03082729|142912110|SUPERIORITY|||||||0.815|||||||t-test, 2 sided|||||||0.815
71698342|NCT03082729|142912111|SUPERIORITY|||||||0.321|||||||t-test, 2 sided|||||||0.321
71698343|NCT03082729|142912111|SUPERIORITY|||||||0.204|||||||t-test, 2 sided|||||||0.204
71698344|NCT03082729|142912112|SUPERIORITY|||||||0.352|||||||t-test, 2 sided|||||||0.352
71698345|NCT03082729|142912112|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||||||0.180
71698346|NCT03082729|142912113|SUPERIORITY|||||||0.094|||||||t-test, 2 sided|||||||0.094
71698347|NCT03082729|142912113|SUPERIORITY|||||||0.383|||||||t-test, 2 sided|||||||0.383
71698348|NCT03082729|142912114|SUPERIORITY|||||||0.024|||||||t-test, 2 sided|||||||0.024
71698349|NCT03082729|142912114|SUPERIORITY|||||||0.266|||||||t-test, 2 sided|||||||0.266
71698350|NCT03082729|142912115|SUPERIORITY|||||||0.042|||||||t-test, 2 sided|||||||0.042
71698351|NCT03082729|142912115|SUPERIORITY|||||||0.208|||||||t-test, 2 sided|||||||0.208
71698352|NCT03082729|142912116|SUPERIORITY|||||||0.446|||||||t-test, 2 sided|||||||0.446
71698353|NCT03082729|142912116|SUPERIORITY|||||||0.611|||||||t-test, 2 sided|||||||0.611
71698354|NCT03082729|142912117|SUPERIORITY|||||||0.014|||||||t-test, 2 sided|||||||0.014
71698355|NCT03082729|142912117|SUPERIORITY|||||||0.405|||||||t-test, 2 sided|||||||0.405
71758607|NCT00836693|143019585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|STANDARD_ERROR_OF_MEAN|3.34||0.0034|TWO_SIDED|95.0|3.3|16.5||p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||16.5|3.3|0.0034
71758608|NCT00836693|143019585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.0|STANDARD_ERROR_OF_MEAN|3.52||0.002|TWO_SIDED|95.0|4.1|17.9||p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||17.9|4.1|0.0020
71758609|NCT00836693|143019585|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.5|STANDARD_ERROR_OF_MEAN|4.07||0.0653|TWO_SIDED|95.0|-0.5|15.6||p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||15.6|-0.5|0.0653
71698356|NCT01898078|142912168|SUPERIORITY_OR_OTHER||Least Squares Mean Ratio|0.97|||||TWO_SIDED|90.0|0.85|1.12|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.||1.12|0.85|
71698357|NCT01898078|142912169|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.16|||||TWO_SIDED|90.0|1.01|1.34|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.||1.34|1.01|
71698358|NCT01898078|142912170|SUPERIORITY_OR_OTHER||Least Square Mean Ratio|1.15|||||TWO_SIDED|90.0|0.96|1.39|||||Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean||1.39|0.96|
71698359|NCT01140906|142912178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.53|STANDARD_ERROR_OF_MEAN|1.09|<|0.0001|TWO_SIDED|95.0|-7.66|-3.4||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.40|-7.66|<0.0001
71698360|NCT01140906|142912178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.09|STANDARD_ERROR_OF_MEAN|1.08|<|0.0001|TWO_SIDED|95.0|-9.21|-4.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-4.97|-9.21|<0.0001
71698361|NCT01140906|142912178|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.45|STANDARD_ERROR_OF_MEAN|1.07|<|0.0001|TWO_SIDED|95.0|-11.55|-7.35||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-7.35|-11.55|<0.0001
71698362|NCT01140906|142912179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.8|||<|0.0001|TWO_SIDED|95.0|1.76|4.47||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.47|1.76|<0.0001
71698363|NCT01140906|142912179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001|TWO_SIDED|95.0|2.1|5.36||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||5.36|2.10|<0.0001
71698364|NCT01140906|142912179|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.94|||<|0.0001|TWO_SIDED|95.0|3.61|9.78||This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted Odds Ratio|||||9.78|3.61|<0.0001
71698365|NCT01140906|142912180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-0.94|-0.44||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.44|-0.94|<0.0001
71698366|NCT01140906|142912180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.2|-0.7||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.70|-1.20|<0.0001
71698367|NCT01140906|142912180|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.12|STANDARD_ERROR_OF_MEAN|0.13|<|0.0001|TWO_SIDED|95.0|-1.36|-0.87||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-0.87|-1.36|<0.0001
71698368|NCT01140906|142912181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.24|STANDARD_ERROR_OF_MEAN|1.53||0.0007|TWO_SIDED|95.0|-8.25|-2.22||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-2.22|-8.25|0.0007
71698369|NCT01140906|142912181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.42|STANDARD_ERROR_OF_MEAN|1.58|<|0.0001|TWO_SIDED|95.0|-9.53|-3.31||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-3.31|-9.53|<0.0001
71698370|NCT01140906|142912181|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.71|STANDARD_ERROR_OF_MEAN|1.54|<|0.0001|TWO_SIDED|95.0|-11.73|-5.69||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-5.69|-11.73|<0.0001
71698371|NCT01140906|142912182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.32||||0.0016|TWO_SIDED|95.0|1.37|3.91||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||3.91|1.37|0.0016
71698372|NCT01140906|142912182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.65||||0.0002|TWO_SIDED|95.0|1.58|4.44||Wald's test. Since p-value \<0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||4.44|1.58|0.0002
71698373|NCT01140906|142912182|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.01|||<|0.0001|TWO_SIDED|95.0|2.99|8.37||Wald's test. This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted for Odds Ratio|||||8.37|2.99|<0.0001
71698374|NCT01140906|142912183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.24|STANDARD_ERROR_OF_MEAN|1.16||0.0054|TWO_SIDED|95.0|-5.51|-0.97||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-0.97|-5.51|0.0054
71698375|NCT01140906|142912183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|1.11||0.0005|TWO_SIDED|95.0|-6.11|-1.73||Since p-value \<0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.||-1.73|-6.11|0.0005
71698376|NCT01140906|142912183|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.93|STANDARD_ERROR_OF_MEAN|1.13|<|0.0001|TWO_SIDED|95.0|-9.16|-4.7||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM|||||-4.70|-9.16|<0.0001
71698377|NCT01140906|142912184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_ERROR_OF_MEAN|0.59||0.2524|TWO_SIDED|95.0|-1.83|0.48||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.48|-1.83|0.2524
71698378|NCT01140906|142912184|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.59||0.4186|TWO_SIDED|95.0|-1.64|0.68||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.|||0.68|-1.64|0.4186
71698379|NCT01140906|142912185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.41||0.7372|TWO_SIDED|95.0|-0.95|0.67||A nominal p-value is provided.|ANCOVA|||||0.67|-0.95|0.7372
71698380|NCT01140906|142912185|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_ERROR_OF_MEAN|0.41||0.169|TWO_SIDED|95.0|-0.24|1.37||A nominal p-value is provided.|ANCOVA|||||1.37|-0.24|0.1690
71698381|NCT02058095|142912229|SUPERIORITY|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||||||0.04
71698382|NCT02058095|142912231|SUPERIORITY|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||||||0.01
71698383|NCT00148798|142912232|SUPERIORITY_OR_OTHER|||||||0.0441|TWO_SIDED|95.0|||||Stratified Log Rank|||Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).||||0.0441
71698384|NCT00148798|142912233|SUPERIORITY_OR_OTHER|||||||0.3869|TWO_SIDED|95.0|||||Stratified Log Rank|||To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).||||0.3869
71698385|NCT00148798|142912234|SUPERIORITY_OR_OTHER|||||||0.0101|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.0101
71698386|NCT00148798|142912235|SUPERIORITY_OR_OTHER|||||||0.6801|TWO_SIDED|95.0|||||Cochran-Mantel-Haenszel|||The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).||||0.6801
71698387|NCT00316004|142912240|SUPERIORITY_OR_OTHER|||||||0.55||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.55
71698388|NCT00316004|142912241|SUPERIORITY_OR_OTHER|||||||0.59||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.||||0.59
71698389|NCT00316004|142912242|SUPERIORITY_OR_OTHER|||||||0.67||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations.||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.||||0.67
71698390|NCT00316004|142912243|SUPERIORITY_OR_OTHER|||||||0.57||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.||||0.57
71698391|NCT00316004|142912244|SUPERIORITY_OR_OTHER|||||||0.84||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.||||.84
71698392|NCT00316004|142912245|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.||||0.88
71698393|NCT00316004|142912246|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.||||0.88
71698394|NCT00316004|142912247|SUPERIORITY_OR_OTHER|||||||0.91||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.||||0.91
71698395|NCT00316004|142912248|SUPERIORITY_OR_OTHER|||||||0.81||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.||||0.81
71698396|NCT00316004|142912249|SUPERIORITY_OR_OTHER|||||||0.77||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.||||0.77
71698397|NCT00316004|142912250|SUPERIORITY_OR_OTHER|||||||0.76||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.||||0.76
71698398|NCT00316004|142912251|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.||||0.43
71698399|NCT00316004|142912252|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.||||0.06
71698400|NCT00316004|142912252|SUPERIORITY_OR_OTHER|||||||0.3||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.||||0.3
71698401|NCT00316004|142912252|SUPERIORITY_OR_OTHER|||||||0.04||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.||||0.04
71698402|NCT00316004|142912252|SUPERIORITY_OR_OTHER|||||||0.06||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.||||0.06
71698403|NCT00316004|142912252|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.||||0.88
71698404|NCT00316004|142912253|SUPERIORITY_OR_OTHER|||||||0.68||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.||||0.68
71698405|NCT00316004|142912254|SUPERIORITY_OR_OTHER|||||||0.43||95.0||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.||||0.43
71698406|NCT00316004|142912255|SUPERIORITY_OR_OTHER|||||||0.88||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.||||0.88
71698407|NCT00316004|142912255|SUPERIORITY_OR_OTHER|||||||0.26||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.||||0.26
71698408|NCT00316004|142912255|SUPERIORITY_OR_OTHER|||||||0.16||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.||||0.16
71698409|NCT00316004|142912255|SUPERIORITY_OR_OTHER|||||||0.17||95.0||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.||||0.17
71698410|NCT02202252|142912256|SUPERIORITY_OR_OTHER|||||||0.49|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.490
71698411|NCT02202252|142912257|SUPERIORITY_OR_OTHER|||||||0.035|TWO_SIDED||||||Chi-squared|||||||0.035
71698412|NCT02202252|142912258|SUPERIORITY_OR_OTHER|||||||0.819|TWO_SIDED||||||Wilcoxon (Mann-Whitney)|||||||0.819
71698413|NCT00977197|142912259|SUPERIORITY_OR_OTHER|||||||0.008|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.008
71698414|NCT00977197|142912260|SUPERIORITY_OR_OTHER|||||||0.009|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.009
71698415|NCT00977197|142912261|SUPERIORITY_OR_OTHER|||||||0.389|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender; rank scale.||||||0.389
71698416|NCT00977197|142912262|SUPERIORITY_OR_OTHER|||||||0.049|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.049
71698417|NCT00977197|142912263|SUPERIORITY_OR_OTHER|||||||0.044|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.044
71698418|NCT00977197|142912264|SUPERIORITY_OR_OTHER|||||||0.35||||||Intent to treat analysis, not adjusted for age and gender.|Chi-squared|||||||0.350
71698419|NCT00977197|142912265|SUPERIORITY_OR_OTHER|||||||0.02|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.020
71698420|NCT00977197|142912266|SUPERIORITY_OR_OTHER|||||||0.024|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.024
71698421|NCT00977197|142912267|SUPERIORITY_OR_OTHER|||||||0.417|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.||||||0.417
71698422|NCT00977197|142912268|SUPERIORITY_OR_OTHER|||||||0.03||||||Intent to Treat analysis; adjusted for age and gender, rank scale.|ANCOVA|||||||0.030
71698423|NCT00977197|142912269|SUPERIORITY_OR_OTHER|||||||0.016|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.||||||0.016
71698424|NCT00977197|142912270|SUPERIORITY_OR_OTHER|||||||0.097||||||Intent to Treat analysis; not adjusted for age and gender.|Chi-squared|||||||0.097
71698425|NCT02842866|142912296|NON_INFERIORITY|The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (\>) -10 percent (%) for all four serogroups.|Difference in percentage|15.7|||||TWO_SIDED|95.0|9.08|22.2||||||Serogroup A||22.2|9.08|
71698426|NCT02842866|142912296|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|27.5|||||TWO_SIDED|95.0|21.2|33.5||||||Serogroup C||33.5|21.2|
71698427|NCT02842866|142912296|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|31.0|||||TWO_SIDED|95.0|24.6|37.0||||||Serogroup Y||37.0|24.6|
71698428|NCT02842866|142912296|NON_INFERIORITY|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was \>-10% for all four serogroups.|Difference in percentage|17.8|||||TWO_SIDED|95.0|11.2|24.2||||||Serogroup W||24.2|11.2|
71698429|NCT02842866|142912297|OTHER||GMT Ratio|1.75|||||TWO_SIDED|95.0|1.4|2.2||||||Serogroup A||2.20|1.40|
71698430|NCT02842866|142912297|OTHER||GMT Ratio|4.1|||||TWO_SIDED|95.0|3.16|5.33||||||Serogroup C||5.33|3.16|
71698431|NCT02842866|142912297|OTHER||GMT Ratio|3.3|||||TWO_SIDED|95.0|2.57|4.23||||||Serogroup Y||4.23|2.57|
71698432|NCT02842866|142912297|OTHER||GMT Ratio|1.81|||||TWO_SIDED|95.0|1.42|2.31||||||Serogroup W||2.31|1.42|
71698433|NCT02897349|142912305|SUPERIORITY||Adjusted Mean Difference (%)|-0.4|STANDARD_ERROR_OF_MEAN|0.13||0.0016|TWO_SIDED|95.0|-0.65|-0.16|||Mixed model repeated measures|||Based on Mixed-effect Model Repeated Measures (MMRM) including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline HbA1c by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||-0.16|-0.65|0.0016
71698434|NCT02897349|142912306|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-6.2|STANDARD_ERROR_OF_MEAN|5.1||0.2241|TWO_SIDED|95.0|-16.2|3.8|||Mixed model repeated measures|||Based on MMRM including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline FPG baseline FPG by week interaction and random effect for patient. Within-patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).||3.8|-16.2|0.2241
71698435|NCT02897349|142912307|SUPERIORITY||Adjusted Mean Difference (mg/dL)|-31.95|STANDARD_ERROR_OF_MEAN|8.2||0.0001|TWO_SIDED|95.0|-48.15|-15.75|||ANCOVA|||Based on analysis of covariance (ANCOVA) model including fixed effect treatment and type of insulin, and linear covariates baseline HbA1c and baseline 2-h PPG.||-15.75|-48.15|0.0001
71698436|NCT02897349|142912308|SUPERIORITY||Odds Ratio (OR)|1.793||||0.2431|TWO_SIDED|95.0|0.673|4.78|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.780|0.673|0.2431
71698437|NCT02897349|142912309|SUPERIORITY||Odds Ratio (OR)|1.481||||0.6235|TWO_SIDED|95.0|0.309|7.105|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||7.105|0.309|0.6235
71698438|NCT02897349|142912310|SUPERIORITY||Odds Ratio (OR)|2.293||||0.0049|TWO_SIDED|95.0|1.286|4.091|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c||4.091|1.286|0.0049
71698439|NCT02737722|142912353|SUPERIORITY|||||||0.5152|||||||Fisher Exact|||Day 1 (Visit 2)||||0.5152
71698440|NCT02737722|142912353|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 1 (Visit 2)||||1.0000
71698441|NCT02737722|142912353|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
71698442|NCT02737722|142912353|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)||||1.0000
71698443|NCT02737722|142912353|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
71698444|NCT02737722|142912353|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)||||1.0000
71698445|NCT02737722|142912353|SUPERIORITY|||||||1|||||||Fisher Exact|||Day 15 (Visit 5)||||1.0000
71698446|NCT02737722|142912353|SUPERIORITY|||||||0.3636|||||||Fisher Exact|||Day 15 (Visit 5)||||0.3636
71698447|NCT02737722|142912354|SUPERIORITY|||||||0.172|||||||Wilcoxon Rank Sum Test|||||||0.172
71698448|NCT02737722|142912354|SUPERIORITY|||||||0.365|||||||Wilcoxon Rank Sum Test|||||||0.365
71698449|NCT02737722|142912354|SUPERIORITY|||||||0.619|||||||Wilcoxon Rank Sum Test|||||||0.619
71698450|NCT02737722|142912355|SUPERIORITY|||||||0.432|||||||Wilcoxon Rank Sum Test|||||||0.432
71698451|NCT02737722|142912355|SUPERIORITY|||||||0.435|||||||Wilcoxon Rank Sum Test|||||||0.435
71698452|NCT02737722|142912355|SUPERIORITY|||||||0.715|||||||Wilcoxon Rank Sum Test|||||||0.715
71698453|NCT02737722|142912356|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
71698454|NCT02737722|142912356|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
71698455|NCT02737722|142912356|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
71698456|NCT02737722|142912357|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71698457|NCT02737722|142912357|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71698458|NCT02737722|142912357|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71698459|NCT02737722|142912358|SUPERIORITY|||||||0.361|||||||Wilcoxon Rank Sum Test|||||||0.361
71698460|NCT02737722|142912358|SUPERIORITY|||||||0.519|||||||Wilcoxon Rank Sum Test|||||||0.519
71698461|NCT02737722|142912358|SUPERIORITY|||||||0.153|||||||Wilcoxon Rank Sum Test|||||||0.153
71698462|NCT02737722|142912359|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71698463|NCT02737722|142912359|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71698464|NCT02737722|142912359|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71698465|NCT02737722|142912361|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71698466|NCT02737722|142912361|SUPERIORITY|||||||0.464|||||||Wilcoxon Rank Sum Test|||||||0.464
71698467|NCT02737722|142912361|SUPERIORITY|||||||0.465|||||||Wilcoxon Rank Sum Test|||||||0.465
71698468|NCT02309359|142912396|OTHER|Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).||||||0.172|||||||Cochran-Armitage trend test|||The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.||||0.172
71698469|NCT00284856|142912420|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.92||||||95.0|0.28|11.56|||||Estimated Value is difference in least squares mean (montelukast - placebo)|||11.56|0.28|
71698470|NCT00284856|142912420|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|10.14||||||95.0|4.5|15.78|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||15.78|4.50|
71698471|NCT00284856|142912420|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-4.22||||||95.0|-9.83|1.38|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||1.38|-9.83|
71698472|NCT00284856|142912421|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.15||||||95.0|-0.25|-0.05|||||Estimated value is difference in least squares mean (montelukast - placebo)|||-0.05|-0.25|
71698473|NCT00284856|142912421|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-0.2||||||95.0|-0.3|-0.1|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||-0.10|-0.30|
71698474|NCT00284856|142912421|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|0.05||||||95.0|-0.05|0.15|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.15|-0.05|
71698475|NCT00284856|142912422|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|5.09||||||95.0|-1.27|11.45|||||Estimated value is difference in least squares mean (montelukast - placebo)|||11.45|-1.27|
71698476|NCT00284856|142912422|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|11.21||||||95.0|4.85|17.58|||||Estimated value is difference in least squares mean (fluticasone - placebo)|||17.58|4.85|
71698477|NCT00284856|142912422|SUPERIORITY_OR_OTHER_LEGACY||Least Squares Mean Difference|-6.13||||||95.0|-12.46|0.2|||||Estimated value is difference in least squares mean (montelukast - fluticasone)|||0.20|-12.46|
71698478|NCT03040726|142912449|OTHER|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||||||0.98
71698479|NCT03040726|142912450|OTHER|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||||||0.40
71698480|NCT03040726|142912451|OTHER|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||||||0.79
71698481|NCT03040726|142912452|OTHER|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||||||0.57
71698482|NCT03699748|142912478|OTHER||Mean Difference (Net)|10.92|||<|0.001|TWO_SIDED|95.0|7.27|14.58|||Type III F test|||||14.58|7.27|<0.001
71698483|NCT03699748|142912481|OTHER||Effect Estimate for 4 Months|12.88|||||TWO_SIDED||||||||12.88 (9.49 - 16.28)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person. The effect estimate column shows the difference between change in the intervention group from baseline and the change in the control group from baseline.|||
71698484|NCT03699748|142912482|OTHER||Effect Estimate for 12 Months|20.65|||||TWO_SIDED||||||||20.65 (6.97 - 24.32)||Effect estimates were expected mean differences in Patient Activation Measure scores between groups from baseline. Effect estimates were estimated using generalized estimating equations (GEE) models as a function of treatment group, categorical time (baseline, 4 months and 12 months), and an interaction term between treatment group and time with an exchangeable correlation clustered within person.|||
71698485|NCT03699748|142912483|OTHER||Median Difference (Net)|11.05||||0.001|TWO_SIDED|95.0|7.09|15.0|||Type III F-test|||||15.00|7.09|0.001
71698486|NCT03699748|142912485|OTHER||Odds Ratio (OR)|0.91|||||TWO_SIDED||||||||0.91 (0.40-2.09)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
71698487|NCT03699748|142912486|OTHER||Odds Ratio (OR)|0.27|||||TWO_SIDED||||||||0.27 (0.03 - 2.85)||Odds Ratios for any ED Use were estimated using logistic regression models.|||
71698488|NCT03699748|142912487|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.18-0.76)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
71698489|NCT03699748|142912488|OTHER||Odds Ratio (OR)|0.42|||||TWO_SIDED||||||||0.42 (0.22-0.79)||Odds Ratios for any emergency room use and any hospitalization use were estimated using logistic regression models.|||
71698490|NCT03699748|142912489|OTHER||Odds Ratio (OR)|0.38|||||TWO_SIDED||||||||0.38 (0.08-1.75)||Odds Ratios for Hospitalization Use were estimated using logistic regression models.|||
71698491|NCT03699748|142912490|OTHER||Odds Ratio, log|5.86|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
71698492|NCT03699748|142912491|OTHER||Odds Ratio (OR)|4.09|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
71698493|NCT03699748|142912492|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months post-enrollment with logistic regression.|||
71698494|NCT03699748|142912493|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||
71698495|NCT03699748|142912494|OTHER||Odds Ratio, log|8.56|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments 4-months and 12-months post-enrollment with logistic regression.|||||
71698496|NCT03699748|142912495|OTHER||Odds Ratio, log|19.55|||||TWO_SIDED||||||||Odds Ratios for Goals of Care Documentation, Advance Directive Documentation, and Physician Order for Life Sustaining Treatment Documentation were estimated based on assessments at 12-months post-enrollment with logistic regression.|||||
71698497|NCT03699748|142912496|OTHER||Effect Estimate|0.65|||||TWO_SIDED||||||||0.65 (0.44-0.98)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data after adjustment for length of follow-up.|||
71698498|NCT03699748|142912497|OTHER||Effect Estimate|0.57|||||TWO_SIDED||||||||0.57 (0.28 - 1.18)||Proportional change in total health care costs are expressed as referent to the control group and were modeled using a generalized linear model with gamma link-log function to account for skewed cost data.|||
71698499|NCT03699748|142912498|OTHER||Odds Ratio (OR)|6.82|||||TWO_SIDED||||||||6.82 (2.46-18.93)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71698500|NCT03699748|142912499|OTHER||Odds Ratio (OR)|3.62|||||TWO_SIDED||||||||3.62 (1.73-7.60)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71698501|NCT03699748|142912500|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Palliative Care were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
71698502|NCT03699748|142912501|OTHER||Odds Ratio (OR)|4.33|||||TWO_SIDED||||||||4.33 (0.89-21.08)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments 4-months and 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71698503|NCT03699748|142912502|OTHER||Odds Ratio (OR)|2.76|||||TWO_SIDED||||||||2.76 (1.01-7.55)||Odds Ratios for palliative care receipt and hospice receipt were estimated based on assessments at 12-months post-enrollment compared with baseline (time of enrollment) using logistic regression.|||
71698504|NCT03699748|142912503|OTHER||Effect Estimate|5.71|||||TWO_SIDED||||||||5.71 (1.56-20.93)||Odds Ratios for any ED Use and any Hospice Receipt were estimated using logistic regression models. Incidence Rate Ratios (IRR) were estimated using Poisson models. All ratios are expressed as referent to the control group.|||
71698505|NCT03658980|142912515|SUPERIORITY||Odds Ratio (OR)|0.233|||<|0.001|TWO_SIDED|95.0|0.131|0.415|||Regression, Logistic|||||0.415|0.131|<0.001
71698506|NCT05471505|142912531|OTHER||Hazard Ratio (HR)|0.752|||<|0.001|TWO_SIDED|95.0|0.719|0.787|||COX Proportional Hazards Regression|||||0.787|0.719|<0.001
71698507|NCT05471505|142912532|OTHER||Hazard Ratio (HR)|0.747|||<|0.001|TWO_SIDED|95.0|0.687|0.813|||COX Proportional Hazards Regression|||||0.813|0.687|<0.001
71698508|NCT05471505|142912533|OTHER||Hazard Ratio (HR)|0.909|||<|0.001|TWO_SIDED|95.0|0.862|0.958|||COX Proportional Hazards Regression|||||0.958|0.862|<0.001
71698509|NCT05471505|142912534|OTHER||Hazard Ratio (HR)|0.948||||0.378|TWO_SIDED|95.0|0.842|1.067|||COX Proportional Hazards Regression|||||1.067|0.842|0.378
71698510|NCT05471505|142912535|OTHER||Hazard Ratio (HR)|0.259|||<|0.001|TWO_SIDED|95.0|0.229|0.294|||COX Proportional Hazards Regression|||||0.294|0.229|<0.001
71698511|NCT05471505|142912536|OTHER||Hazard Ratio (HR)|0.767|||<|0.001|TWO_SIDED|95.0|0.7|0.84|||COX Proportional Hazards Regression|||||0.840|0.700|<0.001
71698512|NCT05471505|142912537|OTHER||Hazard Ratio (HR)|0.932||||0.022|TWO_SIDED|95.0|0.877|0.99|||COX Proportional Hazards Regression|||||0.990|0.877|0.022
71698513|NCT03353220|142912550|OTHER|||||||0.65||||||paired t test|t-test, 2 sided|||||||0.65
71698514|NCT03353220|142912551|OTHER|||||||0.0001||||||paired t test|t-test, 2 sided|||||||0.0001
71698515|NCT03353220|142912552|OTHER|||||||0.0017||||||paired t test|t-test, 2 sided|||||||0.0017
71698516|NCT03353220|142912556|OTHER|||||||0.0189|||||||t-test, 2 sided|||||||0.0189
71698517|NCT00315341|142912571|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||shift table analyses|||categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)\& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases \>2X ULN(either ALT/AST)\& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)\>2X ULN \&remained at this level(both ALT/AST);(5)BL transaminases \>2X ULN(either ALT/AST)\& increased 2X above this level ever(either ALT/AST).||||< 0.05
71698518|NCT01075048|142912594|SUPERIORITY|||||||0.3815|||||||Log Rank|||||||0.3815
71698519|NCT01075048|142912594|SUPERIORITY|||||||0.19|||||||Peto-Peto-Prentice|||||||0.1900
71698520|NCT01075048|142912594|SUPERIORITY|||||||0.1986|||||||Generalized Wilcoxon|||||||0.1986
71698521|NCT01075048|142912594|SUPERIORITY|||||||0.2617|||||||Tarone-Ware|||||||0.2617
71698522|NCT01075048|142912595|SUPERIORITY|||||||0.4488|||||||Log Rank|||||||0.4488
71698523|NCT01075048|142912595|SUPERIORITY|||||||0.2887|||||||Peto-Peto-Prentice|||||||0.2887
71698524|NCT01075048|142912595|SUPERIORITY|||||||0.1851|||||||Generalized Wilcoxon|||||||0.1851
71698525|NCT01075048|142912595|SUPERIORITY|||||||0.2495|||||||Tarone-Ware|||||||0.2495
71698526|NCT01075048|142912597|SUPERIORITY|||||||0.2804|||||||Log Rank|||OS data cutoff as of 12 Oct 2012||||0.2804
71698527|NCT01075048|142912597|SUPERIORITY|||||||0.2469|||||||Log Rank|||OS data cutoff as of 29 Mar 2013||||0.2469
71698528|NCT01075048|142912597|SUPERIORITY|||||||0.1334|||||||Log Rank|||OS data cutoff as of 25 Jul 2013||||0.1334
71698529|NCT01075048|142912597|SUPERIORITY|||||||0.2159|||||||Log Rank|||OS data cutoff as of 20 Feb 2015||||0.2159
71698530|NCT04596293|142912601|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71698531|NCT04596293|142912601|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71698532|NCT04596293|142912602|OTHER|||||||0.6351|||||||Fisher Exact|||||||0.6351
71698533|NCT04596293|142912602|OTHER|||||||0.3108|||||||Fisher Exact|||||||0.3108
71698534|NCT04596293|142912603|OTHER|||||||1|||||||Fisher Exact|||||||1.0000
71698535|NCT04596293|142912603|OTHER|||||||0.6594|||||||Fisher Exact|||||||0.6594
71698536|NCT04596293|142912604|OTHER|||||||0.5808|||||||ANCOVA|||||||0.5808
71698537|NCT04596293|142912604|OTHER|||||||0.2143|||||||ANCOVA|||||||0.2143
71698538|NCT01287936|142912606|SUPERIORITY||||||<|0.001|||||||Wilcoxon Signed Rank test|||||||<0.001
71698539|NCT01287936|142912608|SUPERIORITY|||||||0.004|||||||Wilcoxon Signed Rank test|||||||0.004
71698540|NCT00336544|142912615|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-5.7||||0.0769||95.0|-11.9|0.6|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.6|-11.9|0.0769
71698541|NCT00336544|142912617|NON_INFERIORITY_OR_EQUIVALENCE|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-4.4||||0.0775||95.0|-9.1|0.3|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.||0.3|-9.1|0.0775
71698542|NCT01649765|142912619|SUPERIORITY||Odds Ratio (OR)|1.49|||||TWO_SIDED|95.0|0.64|3.46||||||||3.46|0.64|
71698543|NCT01649765|142912620|SUPERIORITY||Odds Ratio (OR)|2.74|||||TWO_SIDED|95.0|1.15|6.54|||||Definition 1|||6.54|1.15|
71698544|NCT01649765|142912620|SUPERIORITY||Odds Ratio (OR)|2.92|||||TWO_SIDED|95.0|1.19|7.17|||||Definition 2|||7.17|1.19|
71698545|NCT03427411|142912642|NON_INFERIORITY|Non-inferiority was defined as response rates which were sufficiently similar (p\>0.20 by Fisher's exact test).||||||0.6143||||||The p value was calculated and was 0.6143 which is \> 0.2 (pre-defined threshold).|Fisher Exact|||||||0.6143
71698546|NCT00701363|142912658|SUPERIORITY_OR_OTHER|||||||0.0013|TWO_SIDED||||||ANCOVA|||One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.||||0.0013
71698547|NCT00701363|142912658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71698548|NCT00701363|142912658|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANCOVA|||||||<0.0001
71698549|NCT00701363|142912659|SUPERIORITY_OR_OTHER|||||||0.0009|TWO_SIDED||||||t-test, 2 sided|||||||0.0009
71698550|NCT00701363|142912659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71698551|NCT00701363|142912659|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||t-test, 2 sided|||||||<0.0001
71698552|NCT00701363|142912659|SUPERIORITY_OR_OTHER|||||||0.017|TWO_SIDED||||||t-test, 2 sided|||||||0.0170
71698553|NCT00701363|142912660|SUPERIORITY_OR_OTHER|||||||0.0103|TWO_SIDED||||||t-test, 2 sided|||Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.||||0.0103
71698554|NCT00477685|142912678|SUPERIORITY_OR_OTHER|||||||0.01||95.0|||||t-test, 2 sided|||Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.||||0.01
71698555|NCT01394276|142912692|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0237|||||||Exact binomial proportion test|||||||0.0237
71698556|NCT01394276|142912693|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0003|||||||Exact binomial proportion test|||||||0.0003
71698557|NCT01394276|142912705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.808|TWO_SIDED|95.0|-0.3|0.4|||t-test, 2 sided|||At Baseline: mean difference of scores of DAS28 between the two groups was calculated.||0.4|-0.3|0.8080
71698558|NCT01394276|142912705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4884|TWO_SIDED|95.0|-0.5|0.3|||t-test, 2 sided|||At Month 1: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.5|0.4884
71698559|NCT01394276|142912705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.3||||0.0947|TWO_SIDED|95.0|-0.7|0.1|||t-test, 2 sided|||At Month 2: mean difference of scores of DAS28 between the two groups was calculated.||0.1|-0.7|0.0947
71698560|NCT01394276|142912705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.8181|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 4: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.8181
71698561|NCT01394276|142912705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9721|TWO_SIDED|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 6: mean difference of scores of DAS28 between the two groups was calculated.||0.3|-0.4|0.9721
71698562|NCT01394276|142912705|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.5832|TWO_SIDED|95.0|-0.3|0.5|||t-test, 2 sided|||At Month 12: mean difference of scores of DAS28 between the two groups was calculated.||0.5|-0.3|0.5832
71698563|NCT01394276|142912706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.5||||0.4211|TWO_SIDED|95.0|-5.1|12.2|||t-test, 2 sided|||At Baseline: mean difference of scores of fatigue between the two groups was calculated.||12.2|-5.1|0.4211
71698564|NCT01394276|142912706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.1||||0.6749|TWO_SIDED|95.0|-7.9|12.1|||t-test, 2 sided|||At Month 1: mean difference of scores of fatigue between the two groups was calculated.||12.1|-7.9|0.6749
71698565|NCT01394276|142912706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|6.4||||0.1817|TWO_SIDED|95.0|-3.0|15.9|||t-test, 2 sided|||At Month 2: mean difference of scores of fatigue between the two groups was calculated.||15.9|-3.0|0.1817
71698566|NCT01394276|142912706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|2.8||||0.5182|TWO_SIDED|95.0|-5.8|11.4|||t-test, 2 sided|||At Month 4: mean difference of scores of fatigue between the two groups was calculated.||11.4|-5.8|0.5182
71698567|NCT01394276|142912706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|13.7||||0.0025|TWO_SIDED|95.0|4.9|22.6|||t-test, 2 sided|||At Month 6: mean difference of scores of fatigue between the two groups was calculated.||22.6|4.9|0.0025
71698568|NCT01394276|142912706|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|3.9||||0.354|TWO_SIDED|95.0|-4.4|12.1|||t-test, 2 sided|||At Month 12: mean difference of scores of fatigue between the two groups was calculated.||12.1|-4.4|0.3540
71698569|NCT01394276|142912707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.7343|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Baseline: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.7343
71698570|NCT01394276|142912707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.2||||0.1098|TWO_SIDED|95.0|-0.4|0.0|||t-test, 2 sided|||At Month 1: mean difference of scores of HAQ between the two groups was calculated.||0.0|-0.4|0.1098
71698571|NCT01394276|142912707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.4932|TWO_SIDED|95.0|-0.3|0.2|||t-test, 2 sided|||At Month 2: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.3|0.4932
71698572|NCT01394276|142912707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|-0.1||||0.2468|TWO_SIDED|95.0|-0.4|0.1|||t-test, 2 sided|||At Month 4: mean difference of scores of HAQ between the two groups was calculated.||0.1|-0.4|0.2468
71698573|NCT01394276|142912707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.0||||0.9639|TWO_SIDED|95.0|-0.2|0.2|||t-test, 2 sided|||At Month 6: mean difference of scores of HAQ between the two groups was calculated.||0.2|-0.2|0.9639
71698574|NCT01394276|142912707|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.1||||0.6696|TWO_SIDED|95.0|-0.2|0.3|||t-test, 2 sided|||At Month 12: mean difference of scores of HAQ between the two groups was calculated.||0.3|-0.2|0.6696
71698575|NCT00471497|142912751|OTHER||Difference in response rate|22.1|||<|0.0001|TWO_SIDED|95.0|14.5|29.6|||Cochran-Mantel-Haenszel|||||29.6|14.5|<0.0001
71698576|NCT00471497|142912751|OTHER||Difference in response rate|20.4|||<|0.0001|TWO_SIDED|95.0|12.9|28.0|||Cochran-Mantel-Haenszel|||||28.0|12.9|<0.0001
71698577|NCT00471497|142912752|OTHER||Difference in response rate|14.8|||||TWO_SIDED|95.0|2.1|27.5||||||(Low)||27.5|2.1|
71698578|NCT00471497|142912752|OTHER||Difference in response rate|27.4|||||TWO_SIDED|95.0|14.6|40.2||||||(Low)||40.2|14.6|
71698579|NCT00471497|142912752|OTHER||Difference in response rate|27.7|||||TWO_SIDED|95.0|15.0|40.4||||||(Intermediate)||40.4|15.0|
71698580|NCT00471497|142912752|OTHER||Difference in response rate|17.2|||||TWO_SIDED|95.0|4.6|29.8||||||(Intermediate)||29.8|4.6|
71698581|NCT00471497|142912752|OTHER||Difference in response rate|24.4|||||TWO_SIDED|95.0|10.7|38.1||||||(High)||38.1|10.7|
71698582|NCT00471497|142912752|OTHER||Difference in response rate|15.4|||||TWO_SIDED|95.0|2.1|28.6||||||(High)||28.6|2.1|
71698583|NCT00471497|142912753|OTHER||Difference in response rate|21.3|||||TWO_SIDED|95.0|13.9|28.8||||||||28.8|13.9|
71698584|NCT00471497|142912753|OTHER||Difference in response rate|18.7|||||TWO_SIDED|95.0|11.3|26.0||||||||26.0|11.3|
71698585|NCT00471497|142912755|OTHER||Absolute difference|-1.6||||0.6987|TWO_SIDED|95.0|-9.8|6.6|||Cochran-Mantel-Haenszel|||||6.6|-9.8|0.6987
71698586|NCT01654276|142912789|SUPERIORITY_OR_OTHER_LEGACY|||||||0.66|TWO_SIDED||||||t-test, 2 sided|||||||0.66
71698587|NCT04609514|142912808|SUPERIORITY||Median Difference (Final Values)|10.95||||0.51|TWO_SIDED||||||Wilcoxon Rank Sum Test|||||||0.51
71698588|NCT04609514|142912809|SUPERIORITY||||||<|0.001|||||||Wilcoxon Rank Sum Test|||||||<0.001
71698589|NCT04609514|142912814|SUPERIORITY|||||||0.39||||||A robust Yuen's test was conducted with an apriori threshold of 0.05 for statistical significance. No covariates were introduced in the model.|Robust Yuen's test|||||||0.39
71698590|NCT04609514|142912815|SUPERIORITY|||||||0.4|||||||Robust Yuen's test|||||||0.40
71698591|NCT04609514|142912816|SUPERIORITY|||||||0.478|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.478
71698592|NCT04609514|142912817|SUPERIORITY|||||||0.51|||||||Wilcoxon rank sum test|Wilcoxon rank sum test with continuity correction.||||||0.51
71698593|NCT04609514|142912819|SUPERIORITY||Odds Ratio (OR)|1.185||||0.8392|TWO_SIDED|95.0|0.23|6.119|||Regression, Logistic|||||6.119|0.23|0.8392
71698594|NCT04609514|142912820|SUPERIORITY|||||||1|||||||Pearson's Chi-squared test|Pearson's Chi-squared test with Yates' continuity correction.||||||1.00
71698595|NCT00909870|142912822|SUPERIORITY_OR_OTHER||Difference in proportions|6.5||||0.103|TWO_SIDED|95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Chi-squared|Unadjusted||"H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.~HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.~The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%."||||0.1030
71698596|NCT00909870|142912823|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|6.0||||0.4046||95.0||||This p-value did not meet the prespecified threshold for statistical significance of \< 0.05|Log Rank|||||||0.4046
71698597|NCT00909870|142912824|SUPERIORITY_OR_OTHER||Difference in proportions|10.0||||0.0239||95.0||||Unadjusted|Chi-squared|Unadjusted||Pre-specified subgroup analysis of the primary endpoint||||0.0239
71698598|NCT00402831|142912837|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-2.5|2.6||||||Measles difference||2.6|-2.5|
71698599|NCT00402831|142912837|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.1|||||TWO_SIDED|95.0|-3.0|3.3||||||Mumps difference||3.3|-3.0|
71698600|NCT00402831|142912837|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.3|4.1||||||Rubella difference||4.1|-2.3|
71698601|NCT00402831|142912837|NON_INFERIORITY_OR_EQUIVALENCE|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||TWO_SIDED|95.0|-2.1|4.1||||||Varicella||4.1|-2.1|
71698602|NCT04773028|142912850|OTHER||Mean Difference (Final Values)|-93054.0|||<|0.05|TWO_SIDED||||||t-test, 2 sided|||||||<0.05
71698603|NCT03043053|142912851|OTHER||Mean Difference (Final Values)|-0.06|||||TWO_SIDED|95.0|-1.4|1.3||||||||1.3|-1.4|
71698604|NCT03043053|142912852|OTHER||Mean Difference (Final Values)|-29.7|||||TWO_SIDED|95.0|-141.9|82.6|||||Controlled for lean mass. Reported values are outputted by STATA.|||82.6|-141.9|
71698605|NCT03043053|142912853|OTHER||Mean Difference (Final Values)|196.0|||||TWO_SIDED|95.0|-1036.0|1428.0||||||||1428|-1036|
71698606|NCT03043053|142912854|OTHER||Mean Difference (Final Values)|-152.0|||||TWO_SIDED|95.0|-302.3|-1.7||||||||-1.7|-302.3|
71698607|NCT02814526|142912870|SUPERIORITY||Mean Difference (Net)|0.078||||0.29|TWO_SIDED||||||Regression, Linear|||||||0.29
71698608|NCT02814526|142912871|SUPERIORITY||Mean Difference (Net)|0.031||||0.74|TWO_SIDED||||||Regression, Linear|||||||0.74
71698609|NCT02814526|142912872|SUPERIORITY||Mean Difference (Net)|-0.009447||||0.8284|TWO_SIDED||||||Regression, Linear|||||||0.8284
71698610|NCT02814526|142912873|SUPERIORITY||Mean Difference (Net)|-0.02024||||0.7086|TWO_SIDED||||||Regression, Linear|||||||0.7086
71698611|NCT02814526|142912874|SUPERIORITY||Mean Difference (Net)|0.29||||0.06|TWO_SIDED||||||Regression, Linear|||||||0.06
71698612|NCT02814526|142912875|SUPERIORITY||Mean Difference (Net)|-0.17||||0.33|TWO_SIDED||||||Regression, Linear|||||||0.33
71698613|NCT02814526|142912876|SUPERIORITY||Mean Difference (Net)|-0.1||||0.49|TWO_SIDED||||||Regression, Linear|||||||0.49
71698614|NCT02814526|142912877|SUPERIORITY||Mean Difference (Net)|-0.02||||0.61|TWO_SIDED||||||Regression, Linear|||||||0.61
71698615|NCT02814526|142912878|SUPERIORITY||Mean Difference (Net)|-0.01||||0.78|TWO_SIDED||||||Regression, Linear|||||||0.78
71698616|NCT02814526|142912879|SUPERIORITY||Mean Difference (Net)|-0.04||||0.31|TWO_SIDED||||||Regression, Linear|||||||0.31
71698617|NCT02814526|142912880|SUPERIORITY||Mean Difference (Net)|-0.0005||||0.817|TWO_SIDED||||||Regression, Linear|||||||0.817
71698618|NCT02814526|142912881|SUPERIORITY||Mean Difference (Net)|0.002||||0.64|TWO_SIDED||||||Regression, Linear|||||||0.64
71698619|NCT02814526|142912882|SUPERIORITY||Mean Difference (Net)|-0.01||||0.97|TWO_SIDED||||||Regression, Linear|||||||0.97
71698620|NCT02814526|142912883|SUPERIORITY||Mean Difference (Net)|-0.17||||0.94|TWO_SIDED||||||Regression, Linear|||||||0.94
71698621|NCT00251758|142912892|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71698622|NCT00251758|142912892|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71698623|NCT00251758|142912892|SUPERIORITY_OR_OTHER|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.15505
71698624|NCT00251758|142912894|SUPERIORITY_OR_OTHER|||||||1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.00001
71698625|NCT00251758|142912894|SUPERIORITY_OR_OTHER||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg's method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||<0.00001
71698626|NCT00251758|142912894|SUPERIORITY_OR_OTHER|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.||||0.38740
71698627|NCT01387269|142912896|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis||||< 0.0001
71698628|NCT01387269|142912897|SUPERIORITY_OR_OTHER|||||||0.1475|||||||Wilcoxon rank sum test|||Superiority analysis||||0.1475
71698629|NCT01387269|142912898|SUPERIORITY_OR_OTHER|||||||0.0004|||||||Mixed Models Analysis|||Superiority analysis||||0.0004
71698630|NCT01387269|142912899|SUPERIORITY_OR_OTHER|||||||0.0544|||||||Mixed Models Analysis|||Superiority analysis||||0.0544
71698631|NCT01387269|142912900|SUPERIORITY_OR_OTHER||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis||||< 0.0001
71698632|NCT01981616|142912903|NON_INFERIORITY_OR_EQUIVALENCE|"With 55 evaluable participants in each group, the study would have at least 80% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% confidence interval (CI) on the difference in proportions between vedolizumab- and placebo-treated participants, assuming a 90% seroconversion rate (anti-HBs of 10 IU/L) for hepatitis B vaccine.~If the lower bound of this interval was less than -15% (ie, more negative), then the null hypothesis was accepted."|Difference from placebo|-1.8|||||TWO_SIDED|95.0|-12.7|9.1||||||||9.1|-12.7|
71698633|NCT01981616|142912904|NON_INFERIORITY_OR_EQUIVALENCE|The sample size of 55 evaluable subjects in the vedolizumab 750 mg IV group and 55 evaluable participants in the placebo group provided at least 71% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% CI on the difference in proportions between vedolizumab- and placebo-treated participants, assuming an 85% seroconversion rate to the oral cholera vaccine (Dukoral).|Difference from placebo|-14.2|||||TWO_SIDED|95.0|-24.6|-3.9||||||||-3.9|-24.6|
71698634|NCT01141608|142912937|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||Linear mixed effects model|||||||<0.05
71698635|NCT02753881|142912956|OTHER|||||||0.036||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicin.||||.036
71698636|NCT02753881|142912956|OTHER|||||||0.002||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for dose normalized doxorubicinol.||||0.002
71698637|NCT02753881|142912958|OTHER|||||||0.023||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicin.||||0.023
71698638|NCT02753881|142912958|OTHER|||||||0.041||||||Two-sided p-values \<0.05 considered statistically significant.|Kruskal-Wallis|||To achieve high probability (80% power) to detect 50% change with 5% significance level, calculated total sample size was 30 participants for time-concentration-curves for doxorubicinol.||||0.041
71698639|NCT00506675|142912963|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
71698640|NCT00506675|142912964|SUPERIORITY_OR_OTHER|||||||0.3||95.0|||||ANCOVA|||||||0.30
71698641|NCT00506675|142912965|SUPERIORITY_OR_OTHER|||||||0.3|TWO_SIDED|95.0|||||ANCOVA|||||||0.30
71698642|NCT02858908|142912971|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6696||||0.0484|TWO_SIDED|95.0|-1.334|-0.0051|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||-0.0051|-1.3340|0.0484
71698643|NCT02858908|142912971|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.6449||||0.0565|TWO_SIDED|95.0|-1.3094|0.0195|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete 10-metre walk/run test at the preferred speed||0.0195|-1.3094|0.0565
71698644|NCT02858908|142912972|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.9102||||0.3732|TWO_SIDED|95.0|-1.1526|2.973|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||2.9730|-1.1526|0.3732
71698645|NCT02858908|142912972|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.3897||||0.1782|TWO_SIDED|95.0|-3.4525|0.6731|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in grip strength (kg)||0.6731|-3.4525|0.1782
71698646|NCT02858908|142912973|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.0213||||0.8886|TWO_SIDED|95.0|-0.3368|0.2941|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.2941|-0.3368|0.8886
71698647|NCT02858908|142912973|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|0.0152||||0.9204|TWO_SIDED|95.0|-0.3003|0.3307|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in FVC (litres)||0.3307|-0.3003|0.9204
71698648|NCT02858908|142912974|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|-42.75||||1|TWO_SIDED|95.0|-1270.0|2178.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||2178.50|-1270.00|1.0000
71698649|NCT02858908|142912974|OTHER|The exact Wilcoxon signed rank test was used to test for a change in the DXA scan total lean muscle mass (g) from baseline to end of treatment|Median Difference (Net)|426.75||||0.3125|TWO_SIDED|95.0|-289.5|1198.5|||ANCOVA||Hodges-Lehmann estimates for the median and confidence intervals are presented|Changes from baseline to week 12 in the DXA scan total lean muscle mass (g)||1198.50|-289.50|0.3125
71698650|NCT02858908|142912976|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.1||||0.003|TWO_SIDED|95.0|2.6|3.7||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.7|2.6|0.0030
71698651|NCT02858908|142912976|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom.|Mean Difference (Net)|3.0||||0.0009|TWO_SIDED|95.0|2.4|3.6||The p-value is presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in Clinical Global Impression Global Improvement Scale (CGI-I)||3.6|2.4|0.0009
71698652|NCT02858908|142912977|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.132||||0.1857|TWO_SIDED|95.0|-0.33|0.066|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||0.066|-0.330|0.1857
71698653|NCT02858908|142912977|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.325||||0.0054|TWO_SIDED|95.0|-0.549|-0.102|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the weekly total number of 3 minute bouts of activity per hour wear time||-0.102|-0.549|0.0054
71698654|NCT02858908|142912980|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.162||||0.0111|TWO_SIDED|95.0|-3.731|-0.593|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||-0.593|-3.731|0.0111
71698655|NCT02858908|142912980|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.955||||0.2088|TWO_SIDED|95.0|-2.525|0.614|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the time taken (seconds) to complete the nine hole peg test for the dominant arm||0.614|-2.525|0.2088
71698656|NCT02858908|142912981|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.77||||0.0728|TWO_SIDED|95.0|-3.71|0.18|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||0.18|-3.71|0.0728
71698657|NCT02858908|142912981|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.99||||0.0456|TWO_SIDED|95.0|-3.94|-0.04|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the subject top three concerns VAS total score (cm)||-0.04|-3.94|0.0456
71698658|NCT02858908|142912981|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-2.41||||0.0058|TWO_SIDED|95.0|-4.03|-0.8|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.80|-4.03|0.0058
71698659|NCT02858908|142912981|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-1.95||||0.0208|TWO_SIDED|95.0|-3.56|-0.34|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the caregiver top three concerns VAS total score (cm)||-0.34|-3.56|0.0208
71698660|NCT02858908|142912982|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.054||||0.0068|TWO_SIDED|95.0|-0.092|-0.017|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||-0.017|-0.092|0.0068
71698661|NCT02858908|142912982|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-0.009||||0.609|TWO_SIDED|95.0|-0.047|0.028|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the OSU Autism Rating Scale - DSM-IV (OARS-4) total impairment mean||0.028|-0.047|0.6090
71698662|NCT02858908|142912983|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|3.4||||0.0011|TWO_SIDED|95.0|3.0|3.7||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||3.7|3.0|0.0011
71698663|NCT02858908|142912983|OTHER|A mixed effect model repeated measure (MMRM) was fitted to the observed values at week12 in OSU CGI-I. The model included dose group and visit as fixed effects, and the treatment-by-visit interaction. F-tests from PROC MIXED were based on Kenward-Roger's adjusted degrees of freedom. A compound symmetry covariance matrix was used for the repeated visits within subject.|Mean Difference (Net)|4.0||||1|TWO_SIDED|95.0|3.6|4.4||p-values are presented for the comparison of adjusted Least Square Means to a score of 4, representing 'No change'|Mixed Models Analysis|||Observed value at week 12 in OSU global improvement scale for autism (OSU CGI-I)||4.4|3.6|1.0000
71698664|NCT02858908|142912984|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-5.91|||<|0.0001|TWO_SIDED|95.0|-8.35|-3.47|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-3.47|-8.35|<0.0001
71698665|NCT02858908|142912984|OTHER|Analysis of change in efficacy variables from baseline to week 12 were performed using mixed effect model repeated measures (MMRM) with baseline value as a covariate, dose group and visit as fixed effects and a treatment-by-visit interaction. Adjusted least square mean estimates were produced by dose group and study visit and were presented with two-sided 95% confidence intervals and p-values.|Mean Difference (Net)|-3.27||||0.0116|TWO_SIDED|95.0|-5.71|-0.83|||Mixed Models Analysis||The mean difference is an adjusted Least Square Mean|Change from baseline at week 12 in the clinician-completed domain specific causes for concern VAS total score (cm)||-0.83|-5.71|0.0116
71698666|NCT02858908|142912985|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-1.1||||0.6631|TWO_SIDED|95.0|-6.5|4.3|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||4.3|-6.5|0.6631
71698667|NCT02858908|142912985|OTHER|An ANCOVA was fitted to the change in the Peabody Picture Vocabulary Test age-based standard score from baseline to end of treatment. The model included the baseline value as a covariate and dose group as a fixed effect.|Mean Difference (Net)|-0.1||||0.9546|TWO_SIDED|95.0|-5.5|5.2|||ANCOVA||The mean difference is an adjusted Least Square Mean|Change from baseline to week 12 in the peabody picture vocabulary test age-based standard score||5.2|-5.5|0.9546
71698668|NCT03573297|142912995|SUPERIORITY||Hazard Ratio (HR)|0.83||||0.5745|TWO_SIDED|95.0|0.48|1.43||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.43|0.48|0.5745
71698669|NCT03573297|142912995|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.6308|TWO_SIDED|95.0|0.52|1.51||P-value is based on the log-rank test stratified by modified index episode (manic or depressive) and region (US, non-US).|Log Rank||Hazard ratio (Cariprazine 1.5 or 3.0 mg/day vs. Placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable, stratified by modified index episode (manic or depressive) and region (US, non-US).|||1.51|0.52|0.6308
71698670|NCT01499810|142912996|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698671|NCT01499810|142912998|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698672|NCT01499810|142912999|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698673|NCT01499810|142913000|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698674|NCT01499810|142913001|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698675|NCT01499810|142913002|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698676|NCT01499810|142913003|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
71698677|NCT01499810|142913004|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||<0.0001
71698678|NCT01499810|142913005|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
71698679|NCT01499810|142913006|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
71698680|NCT01499810|142913007|SUPERIORITY_OR_OTHER_LEGACY|||||||7e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00007
71698681|NCT01499810|142913008|SUPERIORITY_OR_OTHER_LEGACY|||||||9e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00009
71698682|NCT01499810|142913009|SUPERIORITY_OR_OTHER_LEGACY|||||||4e-05||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.00004
71698683|NCT01499810|142913010|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0001
71698684|NCT01499810|142913011|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0007||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0007
71698685|NCT01499810|142913012|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.001
71698686|NCT01499810|142913013|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0004||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0004
71698687|NCT01499810|142913014|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0002||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.0002
71698688|NCT01499810|142913015|SUPERIORITY_OR_OTHER_LEGACY|||||||0.57||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.57
71698689|NCT01499810|142913016|SUPERIORITY_OR_OTHER_LEGACY|||||||0.54||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.54
71698690|NCT01499810|142913017|SUPERIORITY_OR_OTHER_LEGACY|||||||0.87||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.87
71698691|NCT01499810|142913018|SUPERIORITY_OR_OTHER_LEGACY|||||||0.77||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.77
71698692|NCT01499810|142913019|SUPERIORITY_OR_OTHER_LEGACY|||||||0.06||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.06
71698693|NCT01499810|142913020|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.07
71698694|NCT01499810|142913021|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
71698695|NCT01499810|142913022|SUPERIORITY_OR_OTHER_LEGACY|||||||0.12||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.12
71698696|NCT01499810|142913023|SUPERIORITY_OR_OTHER_LEGACY|||||||0.72||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.72
71698697|NCT01499810|142913024|SUPERIORITY_OR_OTHER_LEGACY|||||||0.37||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.37
71698698|NCT01499810|142913025|SUPERIORITY_OR_OTHER_LEGACY|||||||0.99||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.99
71698699|NCT01499810|142913026|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
71698700|NCT01499810|142913027|SUPERIORITY_OR_OTHER_LEGACY|||||||0.08||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.08
71698701|NCT01499810|142913028|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.35
71698702|NCT01499810|142913029|SUPERIORITY_OR_OTHER_LEGACY|||||||0.22||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.22
71698703|NCT01499810|142913030|SUPERIORITY_OR_OTHER_LEGACY|||||||0.29||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.29
71698704|NCT01499810|142913031|SUPERIORITY_OR_OTHER_LEGACY|||||||0.89||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.89
71698705|NCT01499810|142913032|SUPERIORITY_OR_OTHER_LEGACY|||||||0.65||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.65
71698706|NCT01499810|142913033|SUPERIORITY_OR_OTHER_LEGACY|||||||0.76||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.76
71698707|NCT01499810|142913034|SUPERIORITY_OR_OTHER_LEGACY|||||||0.35||||||Repeated measures analysis|t-test, 2 sided|||Repeated measures analysis||||0.35
71698708|NCT01499810|142913035|SUPERIORITY_OR_OTHER_LEGACY|||||||0.92||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.92
71698709|NCT01499810|142913036|SUPERIORITY_OR_OTHER_LEGACY|||||||0.32||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.32
71698710|NCT01499810|142913037|SUPERIORITY_OR_OTHER_LEGACY|||||||0.4||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.40
71698711|NCT01499810|142913038|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.17
71698712|NCT01499810|142913039|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||||||threshold for statistical significance p\<0.05|t-test, 2 sided|||Repeated measures analysis||||0.014
71698713|NCT02273167|142913058|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|4.5||||0.055|ONE_SIDED|97.5|-4.0|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-4.00|0.055
71698714|NCT02273167|142913058|NON_INFERIORITY_OR_EQUIVALENCE|The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|1.59||||0.328|ONE_SIDED|97.5|-6.91|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||-6.91|0.328
71698715|NCT02273167|142913059|NON_INFERIORITY_OR_EQUIVALENCE|Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|16.56|||<|0.001|ONE_SIDED|97.5|8.11|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||8.11|<0.001
71698716|NCT02273167|142913059|NON_INFERIORITY_OR_EQUIVALENCE|The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|18.74|||<|0.001|ONE_SIDED|97.5|10.32|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|||10.32|<0.001
71698717|NCT02273167|142913060|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
71698718|NCT02273167|142913060|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|TWO_SIDED|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||12.00|-4.80|0.106
71698719|NCT02273167|142913061|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-0.29||||0.569|TWO_SIDED|95.0|-8.74|8.02||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||8.02|-8.74|0.569
71698720|NCT02273167|142913061|NON_INFERIORITY_OR_EQUIVALENCE|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|0.8||||0.455|TWO_SIDED|95.0|-7.65|9.11||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value \<0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate - MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.||9.11|-7.65|0.455
71698721|NCT02273167|142913062|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|7.1||||0.024|TWO_SIDED|95.0|-1.41|15.47|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||15.47|-1.41|0.024
71698722|NCT02273167|142913062|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.|Difference in PDR|2.37||||0.268|TWO_SIDED|95.0|-6.12|10.82||Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.|Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||10.82|-6.12|0.268
71698723|NCT02273167|142913063|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.|Difference in PDR|-0.49||||0.579|TWO_SIDED|95.0|-8.85|8.0|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||8.00|-8.85|0.579
71698724|NCT02273167|142913063|NON_INFERIORITY_OR_EQUIVALENCE|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|0.61||||0.478|TWO_SIDED|95.0|-7.78|9.09|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.||9.09|-7.78|0.478
71698725|NCT05539131|142913105|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.862||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.862
71698726|NCT05539131|142913106|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.662||||||This is p-valu regarding time and group.|Mixed Models Analysis|||||||0.662
71698727|NCT05539131|142913107|SUPERIORITY|The LMM analysis results refer to the F-statistics and associated p-values derived from linear mixed-effects models (LMMs), including fixed effects for time, group, and their interaction.||||||0.318||||||This is p-valu regarding time and group.|ANOVA|||||||0.318
71698728|NCT05539131|142913108|SUPERIORITY|||||||0.273|||||||ANOVA|||||||0.273
71698729|NCT05539131|142913109|SUPERIORITY|||||||0.639|||||||ANOVA|||||||0.639
71698730|NCT05539131|142913110|SUPERIORITY|||||||0.452|||||||ANOVA|||||||0.452
71698731|NCT00498550|142913121|SUPERIORITY||difference in treatment means|-4.54|STANDARD_ERROR_OF_MEAN|2.57||0.088|TWO_SIDED||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.|||||.088
71698732|NCT00849056|142913133|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.75|||<|0.0001|TWO_SIDED|95.0|-0.95|-0.56|||ANCOVA|||||-0.56|-0.95|<0.0001
71698733|NCT03427892|142913151|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
71698734|NCT03427892|142913152|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.93||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.93
71698735|NCT03427892|142913153|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.49||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is RAVLT Score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.49
71698736|NCT03427892|142913153|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.56||||||Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.Reported is delay score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.56
71698737|NCT03427892|142913154|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.221||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. Reported is CW score.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.221
71698738|NCT03427892|142913154|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.306||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.Reported is Inter. score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.306
71758610|NCT00836693|143019586|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.29|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
71698739|NCT03427892|142913155|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.07||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is TMT A.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.07
71698740|NCT03427892|142913155|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.19||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.The above reported is TMT B.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.19
71698741|NCT03427892|142913156|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
71698742|NCT03427892|142913157|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.022||||||To analyze separate one-way repeated measures analyses of variance (ANOVA) were performed. Time (baseline, week 4, week 8) was included as the within-subject factor.Above is from baseline to week 8 for C-SSRS AA, IA, and ABA.|ANOVA|One-way repeated measures (ANOVA) were performed. Time (baseline, wk 4, wk 8) included as within-subject factor. Above is for C-SSRS AA,IA, and ABA.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.022
71698743|NCT03427892|142913157|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.163||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.163
71698744|NCT03427892|142913158|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.133||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.133
71758611|NCT00836693|143019587|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.25||0.0089|TWO_SIDED|95.0|0.2|1.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.1|0.2|0.0089
71698745|NCT03427892|142913159|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
71698746|NCT03427892|142913160|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.002
71698747|NCT03427892|142913161|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.005||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.005
71698748|NCT03427892|142913162|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||<.001
71698749|NCT03427892|142913163|OTHER|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.295||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).||||.295
71698750|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.224||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site||Independent reader assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||0.224
71698751|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH was stratified by study site||Investigator assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.||||<0.001
71698752|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||0.002
71698753|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||<0.001
71698754|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR||||>0.05
71698755|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.024||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.024
71698756|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.099||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.099
71698757|NCT00274456|142913170|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR||||0.002
71698758|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.027|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.027
71698759|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.009
71698760|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.017|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.017
71698761|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
71698762|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
71698763|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||>0.05
71698764|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.085|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR||||0.085
71698765|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.007||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparison was performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed disease control rate (DCR), ie, SD \>= 16 weeks, or CR or PR||||0.007
71698766|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
71698767|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.009
71698768|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.005
71698769|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||>0.05
71698770|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.098||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.098
71698771|NCT00274456|142913171|SUPERIORITY_OR_OTHER_LEGACY|||||||0.014||95.0|||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR||||0.014
71698772|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.0498||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||Independent assessment||||0.0498
71698773|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.607||||0.0524|||||||Log Rank|||Independent assessment||||0.0524
71698774|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.495||||0.0065|||||||Log Rank|||Independent assessment||||0.0065
71698775|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71698776|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71698777|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71698778|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Independent assessment||||>0.05
71698779|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY|||||||0.008||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.008
71698780|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698781|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698782|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.568||||0.012|||||||Log Rank|||Investigator assessment||||0.012
71698783|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.972||||0.001|||||||Log Rank|||Investigator assessment||||0.001
71698784|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.702||||0.076|||||||Log Rank|||Investigator assessment||||0.076
71698785|NCT00274456|142913172|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698786|NCT00274456|142913173|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Independent assessment||||>0.05
71698787|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.013||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment||||0.013
71698788|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.022|||||||Log Rank|||Investigator assessment||||0.022
71698789|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698790|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698791|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|||||||Log Rank|||Investigator assessment||||0.005
71698792|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698793|NCT00274456|142913174|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05|||||||Log Rank|||Investigator assessment||||>0.05
71698794|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY|||||||0.047||95.0||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||||||0.047
71698795|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71698796|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71698797|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71698798|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|0.686||||0.069||95.0|||||Log Rank|||||||0.069
71698799|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY||||||>|0.05||95.0|||||Log Rank|||||||>0.05
71698800|NCT00274456|142913175|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|1.74||||0.008||95.0|||||Log Rank|||||||0.008
71698801|NCT02034006|142913198|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|72.37|||<|0.0001|TWO_SIDED|95.0|23.44|223.42|||Regression, Logistic|||Presence vs. absence of active leakage.||223.42|23.44|<0.0001
71698802|NCT02034006|142913204|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|9.33|||<|0.0001|TWO_SIDED|95.0|3.18|27.36|||Regression, Logistic|||Presence vs. absence of macular edema.||27.36|3.18|<0.0001
71698803|NCT02034006|142913205|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|12.66|||<|0.0001|TWO_SIDED|95.0|3.76|42.67|||Regression, Logistic|||Presence vs. absence of cysts.||42.67|3.76|<0.0001
71698804|NCT02034006|142913206|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|49.8|||<|0.0001|TWO_SIDED|95.0|11.62|213.5|||Regression, Logistic|||Presence vs. absence of intra-retinal fluid.||213.50|11.62|<0.0001
71698805|NCT02034006|142913207|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0||||0.1514|TWO_SIDED|95.0|0.99|1.0|||Regression, Logistic|||Change in Central subfield thickness vs previous visit.||1.00|0.99|0.1514
71698806|NCT02034006|142913208|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0||||0.1265|TWO_SIDED|95.0|0.0|5.63|||Regression, Logistic|||Change in Central subfield volume vs previous visit.||5.63|0.00|0.1265
71698807|NCT02034006|142913210|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|6.91||||0.0103|TWO_SIDED|95.0|1.58|30.23|||Regression, Logistic|||Presence vs. absence of clinically significant abnormalities.||30.23|1.58|0.0103
71698808|NCT02034006|142913211|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.19||||0.0854|TWO_SIDED|95.0|0.9|5.33|||Regression, Logistic|||Gain \< 5 letters vs. Gain \>= 5 letters.||5.33|0.90|0.0854
71698809|NCT02034006|142913212|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.52||||0.0114|TWO_SIDED|95.0|1.23|5.17|||Regression, Logistic|||Gain \< 10 letters vs. Gain \>= 10 letters.||5.17|1.23|0.0114
71698810|NCT02034006|142913213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.47||||0.0049|TWO_SIDED|95.0|0.25|0.91|||Regression, Logistic|||Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.||0.91|0.25|0.0049
71698811|NCT02034006|142913213|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.53||||0.0461|TWO_SIDED|95.0|0.69|44.52|||Regression, Logistic|||Change from baseline in BCVA: Worsened vs. No change||44.52|0.69|0.0461
71698812|NCT01721798|142913275|NON_INFERIORITY|Primary Outcome Analysis: Proportion of women with detectable genital viral load across 24 months|Odds Ratio (OR)|0.87||||0.66|TWO_SIDED|95.0|0.47|1.62|||GEE|||C-IUD is comparator group.||1.62|0.47|0.66
71698813|NCT01721798|142913276|NON_INFERIORITY|Secondary Outcome Analysis of Proportion with Detectable plasma viral load users at 24 months|Odds Ratio (OR)|0.83||||0.64|TWO_SIDED|95.0|0.37|1.86|||GEE|Adjusted as-treated analysis||C-IUD is comparator group.||1.86|0.37|0.64
71698814|NCT01721798|142913278|NON_INFERIORITY|Secondary Outcome Analysis of Allocated IUC continuation at 24 months|Hazard Ratio (HR)|8.61|||<|0.001|TWO_SIDED|95.0|3.03|24.4|||Regression, Cox|||C-IUD is comparator group.||24.4|3.03|<0.001
71698815|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.57|1.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.76|0.57|
71698816|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.52|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.94|0.52|
71698817|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.58|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.98|0.58|
71698818|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.53|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|0.53|
71698819|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.57|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||0.98|0.57|
71698820|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.77|||||TWO_SIDED|95.0|0.61|0.98|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.98|0.61|
71698821|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.9|||||TWO_SIDED|95.0|0.53|1.51|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.51|0.53|
71698822|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.38|0.89|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.89|0.38|
71698823|NCT02081807|142913297|OTHER||Hazard Ratio (HR)|0.69|||||TWO_SIDED|95.0|0.5|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.50|
71698824|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.38|0.69|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.69|0.38|
71698825|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.68|0.86|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Dabigatran vs. Warfarin (as reference group).||0.86|0.68|
71698826|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|0.72|||||TWO_SIDED|95.0|0.65|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.65|
71698827|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.88|1.26|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.26|0.88|
71698828|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|1.01|||||TWO_SIDED|95.0|0.92|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Rivaroxaban vs. Warfarin (as reference group).||1.12|0.92|
71698829|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|1.02|||||TWO_SIDED|95.0|0.94|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.12|0.94|
71698830|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|0.51|||||TWO_SIDED|95.0|0.39|0.66|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.66|0.39|
71698831|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|0.58|||||TWO_SIDED|95.0|0.49|0.68|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).||MarketScan-Apixaban vs. Warfarin (as reference group).||0.68|0.49|
71698832|NCT02081807|142913298|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.49|0.64|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.64|0.49|
71698833|NCT02081807|142913299|OTHER||Hazard Ratio (HR)|0.87|||||TWO_SIDED|95.0|0.69|1.11|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.11|0.69|
71698834|NCT02081807|142913299|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.66|1.02|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.02|0.66|
71698835|NCT02081807|142913299|OTHER||Hazard Ratio (HR)|0.64|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.88|0.47|
71698836|NCT02081807|142913300|OTHER||Hazard Ratio (HR)|1.85|||||TWO_SIDED|95.0|1.03|3.3|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||3.30|1.03|
71698837|NCT02081807|142913300|OTHER||Hazard Ratio (HR)|1.05|||||TWO_SIDED|95.0|0.65|1.71|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.71|0.65|
71698838|NCT02081807|142913300|OTHER||Hazard Ratio (HR)|0.31|||||TWO_SIDED|95.0|0.1|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.96|0.10|
71698839|NCT02081807|142913301|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.63|1.12|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.12|0.63|
71698840|NCT02081807|142913301|OTHER||Hazard Ratio (HR)|0.74|||||TWO_SIDED|95.0|0.57|0.96|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.96|0.57|
71698841|NCT02081807|142913301|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.45|0.94|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.94|0.45|
71698842|NCT02081807|142913302|OTHER||Hazard Ratio (HR)|0.37|||||TWO_SIDED|95.0|0.18|0.78|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.78|0.18|
71698843|NCT02081807|142913302|OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.58|1.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.72|0.58|
71698844|NCT02081807|142913302|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.38|1.87|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.87|0.38|
71698845|NCT02081807|142913304|OTHER||Hazard Ratio (HR)|0.39|||||TWO_SIDED|95.0|0.25|0.59|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.59|0.25|
71698846|NCT02081807|142913304|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.51|0.95|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||0.95|0.51|
71698847|NCT02081807|142913304|OTHER||Hazard Ratio (HR)|0.67|||||TWO_SIDED|95.0|0.43|1.03|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.03|0.43|
71698848|NCT02081807|142913305|OTHER||Hazard Ratio (HR)|0.75|||||TWO_SIDED|95.0|0.67|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.67|
71698849|NCT02081807|142913305|OTHER||Hazard Ratio (HR)|1.06|||||TWO_SIDED|95.0|0.97|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.97|
71698850|NCT02081807|142913305|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.47|0.63|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.63|0.47|
71698851|NCT02081807|142913306|OTHER||Hazard Ratio (HR)|0.89|||||TWO_SIDED|95.0|0.77|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.04|0.77|
71698852|NCT02081807|142913306|OTHER||Hazard Ratio (HR)|1.21|||||TWO_SIDED|95.0|1.07|1.36|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.36|1.07|
71698853|NCT02081807|142913306|OTHER||Hazard Ratio (HR)|0.59|||||TWO_SIDED|95.0|0.48|0.72|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.72|0.48|
71698854|NCT02081807|142913307|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.44|0.8|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.80|0.44|
71698855|NCT02081807|142913307|OTHER||Hazard Ratio (HR)|1.24|||||TWO_SIDED|95.0|0.98|1.57|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.57|0.98|
71698856|NCT02081807|142913307|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.54|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.14|0.54|
71698857|NCT02081807|142913308|OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.79|1.08|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.08|0.79|
71698858|NCT02081807|142913308|OTHER||Hazard Ratio (HR)|1.19|||||TWO_SIDED|95.0|1.05|1.35|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.35|1.05|
71698859|NCT02081807|142913308|OTHER||Hazard Ratio (HR)|0.54|||||TWO_SIDED|95.0|0.44|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.44|
71698860|NCT02081807|142913310|OTHER||Hazard Ratio (HR)|0.68|||||TWO_SIDED|95.0|0.59|78.0|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||078|0.59|
71698861|NCT02081807|142913310|OTHER||Hazard Ratio (HR)|1.04|||||TWO_SIDED|95.0|0.93|1.16|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.16|0.93|
71698862|NCT02081807|142913310|OTHER||Hazard Ratio (HR)|0.56|||||TWO_SIDED|95.0|0.47|0.67|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.67|0.47|
71698863|NCT02081807|142913311|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.34|0.82|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.82|0.34|
71698864|NCT02081807|142913311|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.55|1.29|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.29|0.55|
71698865|NCT02081807|142913311|OTHER||Hazard Ratio (HR)|0.76|||||TWO_SIDED|95.0|0.41|1.42|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.42|0.41|
71698866|NCT02081807|142913312|OTHER||Hazard Ratio (HR)|0.83|||||TWO_SIDED|95.0|0.6|1.15|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||1.15|0.60|
71698867|NCT02081807|142913312|OTHER||Hazard Ratio (HR)|0.85|||||TWO_SIDED|95.0|0.63|1.14|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.14|0.63|
71698868|NCT02081807|142913312|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.53|1.18|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||1.18|0.53|
71698869|NCT02081807|142913313|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.5|0.84|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.84|0.50|
71698870|NCT02081807|142913313|OTHER||Hazard Ratio (HR)|0.84|||||TWO_SIDED|95.0|0.69|1.01|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group).||1.01|0.69|
71698871|NCT02081807|142913313|OTHER||Hazard Ratio (HR)|0.53|||||TWO_SIDED|95.0|0.37|0.76|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.76|0.37|
71698872|NCT02081807|142913314|OTHER||Hazard Ratio (HR)|0.65|||||TWO_SIDED|95.0|0.47|0.88|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).||0.88|0.47|
71698873|NCT02081807|142913314|OTHER||Hazard Ratio (HR)|0.82|||||TWO_SIDED|95.0|0.65|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.04|0.65|
71698874|NCT02081807|142913314|OTHER||Hazard Ratio (HR)|0.6|||||TWO_SIDED|95.0|0.39|0.92|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.92|0.39|
71698875|NCT02081807|142913315|OTHER||Hazard Ratio (HR)|0.7|||||TWO_SIDED|95.0|0.47|1.04|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Dabigatran vs. Warfarin (as reference group).||1.04|0.47|
71698876|NCT02081807|142913315|OTHER||Hazard Ratio (HR)|0.79|||||TWO_SIDED|95.0|0.6|1.05|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).||1.05|0.60|
71698877|NCT02081807|142913315|OTHER||Hazard Ratio (HR)|0.42|||||TWO_SIDED|95.0|0.24|0.73|||Regression, Cox|Cox proportional-hazards regression analysis was used to compute pooled HR and corresponding 95% CI using fixed effect meta-analysis.||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).||0.73|0.24|
71698878|NCT00091819|142913328|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|1.0||||||95.0|-4.8|6.8||p-values were not calculated in deference to confidence intervals.|||"Statistical analysis applies to cure"|||6.8|-4.8|
71698879|NCT00961415|142913329|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.5|||<|0.001|TWO_SIDED|95.0|0.37|0.69|||Log Rank|||||0.69|0.37|<0.001
71698880|NCT00961415|142913330|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.75||||0.23|TWO_SIDED|95.0|0.47|1.2|||Log Rank|||||1.20|0.47|0.230
71698881|NCT00961415|142913332|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.53||||0.006|TWO_SIDED|95.0|0.34|0.84|||Log Rank|||||0.84|0.34|0.006
71698882|NCT00961415|142913333|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.52|||<|0.001|TWO_SIDED|95.0|0.38|0.7|||Log Rank|||||0.70|0.38|<0.001
71698883|NCT02592824|142913445|SUPERIORITY|||||||0.086|||||||t-test, 2 sided|||Two-sided Student's t-test used for sample size estimation which was based on data from the first GLUTAMICS trial.||||0.086
71698884|NCT02592824|142913446|SUPERIORITY|||||||0.97|||||||t-test, 2 sided|||||||0.97
71698885|NCT02592824|142913447|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71698886|NCT02592824|142913452|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||||||0.007
71698887|NCT00560404|142913462|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15.|Difference of response rates|-0.02|||||TWO_SIDED|95.0|-0.25|0.2||||||||0.20|-0.25|
71698888|NCT00392223|142913488|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.47||||||95.0|-2.48|1.54|||||Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.|||1.54|-2.48|
71698889|NCT00392223|142913492|NON_INFERIORITY_OR_EQUIVALENCE|Analysis performed to assess non-inferiority by calculation \& examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.87||||||95.0|-2.58|0.84|||||ANCOVA adjusted for baseline, center and treatment.|||0.84|-2.58|
71698890|NCT01991795|142913494|SUPERIORITY||Hazard Ratio (HR)|0.9||||0.0378|TWO_SIDED|95.0|0.81|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.81|0.0378
71698891|NCT01991795|142913495|SUPERIORITY||Hazard Ratio (HR)|1.02||||0.7883|TWO_SIDED|95.0|0.88|1.18||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||1.18|0.88|0.7883
71698892|NCT01991795|142913496|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.0294|TWO_SIDED|95.0|0.71|0.98||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.98|0.71|0.0294
71698893|NCT01991795|142913497|SUPERIORITY||Hazard Ratio (HR)|0.8||||0.0375|TWO_SIDED|95.0|0.64|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox|||||0.99|0.64|0.0375
71698894|NCT01991795|142913498|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.6846|TWO_SIDED|95.0|0.87|1.1|||Regression, Cox|||||1.10|0.87|0.6846
71698895|NCT01991795|142913499|SUPERIORITY||Hazard Ratio (HR)|2.32|||<|0.0001|TWO_SIDED|95.0|1.82|2.94|||Regression, Cox|||||2.94|1.82|<0.0001
71698896|NCT01991795|142913500|SUPERIORITY||Hazard Ratio (HR)|2.49|||<|0.0001|TWO_SIDED|95.0|2.02|3.07|||Regression, Cox|||||3.07|2.02|<0.0001
71698897|NCT01991795|142913501|SUPERIORITY||Hazard Ratio (HR)|2.41|||<|0.0001|TWO_SIDED|95.0|1.98|2.93|||Regression, Cox|||||2.93|1.98|<0.0001
71698898|NCT01991795|142913502|SUPERIORITY||Hazard Ratio (HR)|4.04|||<|0.0001|TWO_SIDED|95.0|3.32|4.92|||Regression, Cox|||||4.92|3.32|<0.0001
71698899|NCT06119854|142913503|OTHER||Risk Ratio (RR)|1.207|||||TWO_SIDED|95.0|0.406|3.59|||||The CBT arm is the numerator and the standard arm is the denominator.|||3.590|0.406|
71698900|NCT06119854|142913503|OTHER||Risk Difference (RD)|0.003|||||TWO_SIDED|95.0|-0.013|0.018|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.018|-0.013|
71698901|NCT06119854|142913503|OTHER||Risk Ratio (RR)|0.687|||||TWO_SIDED|95.0|0.194|2.436|||||The inoculation arm is the numerator and the standard arm is the denominator.|||2.436|0.194|
71698902|NCT06119854|142913503|OTHER||Risk Difference (RD)|-0.004|||||TWO_SIDED|95.0|-0.018|0.01|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.010|-0.018|
71698903|NCT06119854|142913504|OTHER||Risk Ratio (RR)|0.992|||||TWO_SIDED|95.0|0.785|1.253|||||The CBT arm is the numerator and the standard arm is the denominator.|||1.253|0.785|
71698904|NCT06119854|142913504|OTHER||Risk Difference (RD)|-0.003|||||TWO_SIDED|95.0|-0.063|0.058|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.058|-0.063|
71698905|NCT06119854|142913504|OTHER||Risk Ratio (RR)|1.227|||||TWO_SIDED|95.0|0.981|1.534|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.534|0.981|
71698906|NCT06119854|142913504|OTHER||Risk Difference (RD)|0.07|||||TWO_SIDED|95.0|0.008|0.133|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.133|0.008|
71698907|NCT06119854|142913505|OTHER||Risk Ratio (RR)|1.063|||||TWO_SIDED|95.0|0.74|1.527|||||CBT group represents the numerator and standard (conventional) represents the denominator|||1.527|0.740|
71698908|NCT06119854|142913505|OTHER||Risk Difference (RD)|0.008|||||TWO_SIDED|95.0|-0.037|0.053|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm|||0.053|-0.037|
71698909|NCT06119854|142913505|OTHER||Risk Ratio (RR)|1.262|||||TWO_SIDED|95.0|0.892|1.784|||||The inoculation arm is the numerator and the standard arm is the denominator.|||1.784|0.892|
71698910|NCT06119854|142913505|OTHER||Risk Difference (RD)|0.034|||||TWO_SIDED|95.0|-0.013|0.08|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.080|-0.013|
71698911|NCT06119854|142913506|OTHER||Risk Ratio (RR)|1.131|||||TWO_SIDED|95.0|0.911|1.406|||||CBT arm is the numerator and the standard arm is the denominator.|||1.406|0.911|
71698912|NCT06119854|142913506|OTHER||Risk Difference (RD)|0.045|||||TWO_SIDED|95.0|-0.019|0.109|||||RD was calculated as the risk in the CBT arm minus the risk in the standard arm.|||0.109|-0.019|
71698913|NCT06119854|142913506|OTHER||Risk Ratio (RR)|1.323|||||TWO_SIDED|95.0|1.074|1.631|||||the inoculation arm is the numerator and the standard arm is the denominator.|||1.631|1.074|
71698914|NCT06119854|142913506|OTHER||Risk Difference (RD)|0.111|||||TWO_SIDED|95.0|0.045|0.176|||||RD was calculated as the risk in the inoculation arm minus the risk in the standard arm.|||0.176|0.045|
71698915|NCT03104374|142913508|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|32.8|||<|0.0001|TWO_SIDED|95.0|24.0|41.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||41.6|24.0|<0.0001
71698916|NCT03104374|142913508|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|39.7|||<|0.0001|TWO_SIDED|95.0|31.1|48.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||48.3|31.1|<0.0001
71698917|NCT03104374|142913509|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Least Squares (LS) Mean Difference|-0.21|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.12|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.12|-0.30|<0.0001
71698918|NCT03104374|142913509|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.4|-0.22|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-0.22|-0.40|<0.0001
71698919|NCT03104374|142913510|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|27.6|||<|0.0001|TWO_SIDED|95.0|19.2|36.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||36.1|19.2|<0.0001
71698920|NCT03104374|142913510|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|31.0|||<|0.0001|TWO_SIDED|95.0|22.3|39.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.8|22.3|<0.0001
71698921|NCT03104374|142913511|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|36.3|||<|0.0001|TWO_SIDED|95.0|25.6|46.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||46.9|25.6|<0.0001
71698922|NCT03104374|142913511|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|40.5|||<|0.0001|TWO_SIDED|95.0|29.9|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||51.0|29.9|<0.0001
71698923|NCT03104374|142913512|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.52|||<|0.0001|TWO_SIDED|95.0|2.07|4.98|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||4.98|2.07|<0.0001
71698924|NCT03104374|142913512|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|5.44|||<|0.0001|TWO_SIDED|95.0|3.99|6.88|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||6.88|3.99|<0.0001
71698925|NCT03104374|142913513|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|3.7|||<|0.0001|TWO_SIDED|95.0|2.0|5.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||5.4|2.0|<0.0001
71698926|NCT03104374|142913513|SUPERIORITY||LS Mean Difference|4.8|||<|0.0001|TWO_SIDED|95.0|3.1|6.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.||6.4|3.1|<0.0001
71698927|NCT03104374|142913514|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|22.3|||<|0.0001|TWO_SIDED|95.0|16.0|28.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||28.6|16.0|<0.0001
71698928|NCT03104374|142913514|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|Response Rate Difference|26.1|||<|0.0001|TWO_SIDED|95.0|19.7|32.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||32.5|19.7|<0.0001
71698929|NCT03104374|142913515|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-22.9|||<|0.0001|TWO_SIDED|95.0|-27.4|-18.4|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-18.4|-27.4|<0.0001
71698930|NCT03104374|142913515|SUPERIORITY|The overall type I error rate of primary and ranked key secondary endpoints was strongly controlled using a graphical multiple testing procedure starting with the primary endpoint using α/2 for each dose followed by a prespecified α transfer path.|LS Mean Difference|-28.2|||<|0.0001|TWO_SIDED|95.0|-32.7|-23.8|||Mixed Effect Model Repeated Measurement|MMRM analysis including treatment, visit, treatment-by-visit interaction, current DMARD use (yes/no) as fixed factors and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo|||-23.8|-32.7|<0.0001
71698931|NCT03104374|142913516|SUPERIORITY||Response Rate Difference|27.0|||<|0.0001|TWO_SIDED|95.0|20.1|33.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||33.9|20.1|<0.0001
71698932|NCT03104374|142913516|SUPERIORITY||Response Rate Difference|32.9|||<|0.0001|TWO_SIDED|95.0|25.9|39.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||39.9|25.9|<0.0001
71698933|NCT03104374|142913517|SUPERIORITY||Response Rate Difference|8.1|||<|0.0001|TWO_SIDED|95.0|4.2|11.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||11.9|4.2|<0.0001
71698934|NCT03104374|142913517|SUPERIORITY||Response Rate Difference|16.0|||<|0.0001|TWO_SIDED|95.0|11.0|21.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||21.1|11.0|<0.0001
71698935|NCT03104374|142913518|SUPERIORITY||Response Rate Difference|21.9|||<|0.0001|TWO_SIDED|95.0|14.3|29.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||29.4|14.3|<0.0001
71698936|NCT03104374|142913518|SUPERIORITY||Response Rate Difference|22.6|||<|0.0001|TWO_SIDED|95.0|15.1|30.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for the main stratification factor of current DMARD use (yes/no).|Response Rate Difference = Upadacitinib - Placebo|||30.2|15.1|<0.0001
71698937|NCT01232283|142913524|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|23.0|||<|0.0001|TWO_SIDED|95.0|16.3|29.6|||Chi-squared|||||29.6|16.3|<0.0001
71698938|NCT01232283|142913525|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|16.1|||<|0.0001|TWO_SIDED|95.0|10.2|21.9|||Chi-squared|||||21.9|10.2|<0.0001
71698939|NCT01232283|142913526|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Mean|-42.15|||<|0.0001|TWO_SIDED|95.0|-51.11|-33.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-33.20|-51.11|<0.0001
71698940|NCT01232283|142913527|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-34.8|||<|0.0001|TWO_SIDED|95.0|-42.4|-27.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-27.2|-42.4|<0.0001
71698941|NCT01232283|142913528|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|35.8|||<|0.0001|TWO_SIDED|95.0|26.9|44.7|||Chi-squared|||||44.7|26.9|< 0.0001
71698942|NCT01232283|142913529|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-21.3|||<|0.0001|TWO_SIDED|95.0|-28.4|-14.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-14.2|-28.4|<0.0001
71698943|NCT01232283|142913530|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-5.3|-2.8|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||-2.8|-5.3|<0.0001
71698944|NCT01232283|142913531|SUPERIORITY_OR_OTHER_LEGACY||LS Mean Difference|2.63||||0.0078|TWO_SIDED|95.0|0.69|4.56|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.||||4.56|0.69|0.0078
71698945|NCT01232283|142913532|SUPERIORITY_OR_OTHER_LEGACY||Risk Difference (RD)|14.2|||<|0.0001|TWO_SIDED|95.0|8.5|20.0|||Chi-squared|||||20.0|8.5|<0.0001
71698946|NCT01232283|142913533|SUPERIORITY_OR_OTHER_LEGACY||Hazard Ratio (HR)|7.7|||<|0.0001|TWO_SIDED|95.0|3.408|17.399|||Log Rank|||||17.399|3.408|<0.0001
71698947|NCT02966834|142913553|OTHER||Mean Difference (Net)|-0.47|||||TWO_SIDED|95.0|-1.75|0.82||||||||0.82|-1.75|
71698948|NCT02966834|142913553|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.07|0.31||||||||0.31|-2.07|
71698949|NCT02966834|142913553|OTHER||Mean Difference (Net)|-0.88|||||TWO_SIDED|95.0|-2.03|0.28||||||||0.28|-2.03|
71698950|NCT02966834|142913553|OTHER||Mean Difference (Net)|-1.13|||||TWO_SIDED|95.0|-2.29|0.03||||||||0.03|-2.29|
71698951|NCT02966834|142913553|OTHER||Mean Difference (Net)|-0.53|||||TWO_SIDED|95.0|-1.71|0.65||||||||0.65|-1.71|
71698952|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-1.9|2.3|||||Symptoms|||2.3|-1.9|
71698953|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.5|2.5|||||Symptoms|||2.5|-1.5|
71698954|NCT02966834|142913554|OTHER||Mean Difference (Net)|-1.1|||||TWO_SIDED|95.0|-3.1|0.8|||||Symptoms|||0.8|-3.1|
71698955|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-1.8|2.0|||||Symptoms|||2.0|-1.8|
71698956|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.0|1.9|||||Symptoms|||1.9|-2.0|
71698957|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.3|2.2|||||Itch|||2.2|-1.3|
71698958|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.8|1.3|||||Itch|||1.3|-1.8|
71698959|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.2|||||Itch|||1.2|-1.9|
71698960|NCT02966834|142913554|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-2.6|0.5|||||Itch|||0.5|-2.6|
71698961|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.9|1.3|||||Itch|||1.3|-1.9|
71698962|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-4.5|3.2|||||Fatigue|||3.2|-4.5|
71698963|NCT02966834|142913554|OTHER||Median Difference (Net)|0.7|||||TWO_SIDED|95.0|-2.8|4.2|||||Fatigue|||4.2|-2.8|
71698964|NCT02966834|142913554|OTHER||Mean Difference (Net)|3.5|||||TWO_SIDED|95.0|0.0|7.0|||||Fatigue|||7.0|0.0|
71698965|NCT02966834|142913554|OTHER||Mean Difference (Net)|1.7|||||TWO_SIDED|95.0|-1.8|5.1|||||Fatigue|||5.1|-1.8|
71698966|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-3.6|3.6|||||Fatigue|||3.6|-3.6|
71698967|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.5|2.6|||||Cognitive|||2.6|-2.5|
71698968|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.9|1.7|||||Cognitive|||1.7|-2.9|
71698969|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.1|2.5|||||Cognitive|||2.5|-2.1|
71698970|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.5|||||TWO_SIDED|95.0|-1.8|2.8|||||Cognitive|||2.8|-1.8|
71698971|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.2|2.5|||||Cognitive|||2.5|-2.2|
71698972|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-2.1|0.4|||||Emotional|||0.4|-2.1|
71698973|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.9|1.3|||||Emotional|||1.3|-0.9|
71698974|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
71698975|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.8|||||TWO_SIDED|95.0|-1.9|0.3|||||Emotional|||0.3|-1.9|
71698976|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-1.2|1.1|||||Emotional|||1.1|-1.2|
71698977|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-2.4|3.0|||||Social|||3.0|-2.4|
71698978|NCT02966834|142913554|OTHER||Mean Difference (Net)|1.2|||||TWO_SIDED|95.0|-1.3|3.7|||||Social|||3.7|-1.3|
71698979|NCT02966834|142913554|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-2.3|2.7|||||Social|||2.7|-2.3|
71698980|NCT02966834|142913554|OTHER||Mean Difference (Net)|-2.4|||||TWO_SIDED|95.0|-4.8|0.1|||||Social|||0.1|-4.8|
71698981|NCT02966834|142913554|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-2.8|2.4|||||Social|||2.4|-2.8|
71698982|NCT02966834|142913555|OTHER||Mean Difference (Net)|-106.8|||||TWO_SIDED|95.0|-251.7|38.2||||||||38.2|-251.7|
71698983|NCT02966834|142913555|OTHER||Mean Difference (Net)|-87.4|||||TWO_SIDED|95.0|-198.5|23.8||||||||23.8|-198.5|
71698984|NCT02966834|142913555|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-125.6|126.5||||||||126.5|-125.6|
71698985|NCT02966834|142913555|OTHER||Mean Difference (Net)|-78.3|||||TWO_SIDED|95.0|-211.5|54.8||||||||54.8|-211.5|
71698986|NCT02966834|142913555|OTHER||Mean Difference (Net)|-30.0|||||TWO_SIDED|95.0|-170.7|110.7||||||||110.7|-170.7|
71698987|NCT02966834|142913557|OTHER||Mean Difference (Net)|-21.4|||||TWO_SIDED|95.0|-58.4|15.5||||||||15.5|-58.4|
71698988|NCT02966834|142913557|OTHER||Mean Difference (Net)|-12.7|||||TWO_SIDED|95.0|-41.9|16.4||||||||16.4|-41.9|
71698989|NCT02966834|142913557|OTHER||Mean Difference (Net)|-15.0|||||TWO_SIDED|95.0|-49.9|20.0||||||||20.0|-49.9|
71698990|NCT02966834|142913557|OTHER||Mean Difference (Net)|-26.5|||||TWO_SIDED|95.0|-63.3|10.4||||||||10.4|-63.3|
71698991|NCT02966834|142913557|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-36.7|37.1||||||||37.1|-36.7|
71698992|NCT02966834|142913558|OTHER||Mean Difference (Net)|-20.0|||||TWO_SIDED|95.0|-52.73|12.74||||||||12.74|-52.73|
71698993|NCT02966834|142913558|OTHER||Mean Difference (Net)|-24.7|||||TWO_SIDED|95.0|-50.8|1.39||||||||1.39|-50.80|
71698994|NCT02966834|142913558|OTHER||Mean Difference (Net)|-22.61|||||TWO_SIDED|95.0|-53.39|8.16||||||||8.16|-53.39|
71698995|NCT02966834|142913558|OTHER||Mean Difference (Net)|-31.67|||||TWO_SIDED|95.0|-63.44|0.09||||||||0.09|-63.44|
71698996|NCT02966834|142913558|OTHER||Mean Difference (Net)|-5.79|||||TWO_SIDED|95.0|-38.33|26.74||||||||26.74|-38.33|
71698997|NCT02966834|142913559|OTHER||Mean Difference (Net)|-106.0|||||TWO_SIDED|95.0|-205.1|-6.8||||||||-6.8|-205.1|
71698998|NCT02966834|142913559|OTHER||Mean Difference (Net)|-65.5|||||TWO_SIDED|95.0|-148.5|17.6||||||||17.6|-148.5|
71698999|NCT02966834|142913559|OTHER||Mean Difference (Net)|-42.8|||||TWO_SIDED|95.0|-136.5|50.9||||||||50.9|-136.5|
71699000|NCT02966834|142913559|OTHER||Mean Difference (Net)|-65.8|||||TWO_SIDED|95.0|-161.2|29.5||||||||29.5|-161.2|
71699001|NCT02966834|142913559|OTHER||Mean Difference (Net)|-54.1|||||TWO_SIDED|95.0|-153.6|45.3||||||||45.3|-153.6|
71699002|NCT02966834|142913560|OTHER||Mean Difference (Net)|-6.099|||||TWO_SIDED|95.0|-11.929|-0.268||||||||-0.268|-11.929|
71699003|NCT02966834|142913560|OTHER||Mean Difference (Net)|-2.337|||||TWO_SIDED|95.0|-6.962|2.289||||||||2.289|-6.962|
71699004|NCT02966834|142913560|OTHER||Mean Difference (Net)|-2.232|||||TWO_SIDED|95.0|-7.679|3.215||||||||3.215|-7.679|
71699005|NCT02966834|142913560|OTHER||Mean Difference (Net)|-1.492|||||TWO_SIDED|95.0|-7.413|4.43||||||||4.430|-7.413|
71699006|NCT02966834|142913560|OTHER||Mean Difference (Net)|5.236|||||TWO_SIDED|95.0|-0.591|11.063||||||||11.063|-0.591|
71699007|NCT02966834|142913561|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-2.7|1.6||||||||1.6|-2.7|
71699008|NCT02966834|142913561|OTHER||Mean Difference (Net)|0.3|||||TWO_SIDED|95.0|-1.5|2.1||||||||2.1|-1.5|
71699009|NCT02966834|142913561|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.2|2.7||||||||2.7|-1.2|
71699010|NCT02966834|142913561|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-2.1|2.0||||||||2.0|-2.1|
71699011|NCT02966834|142913561|OTHER||Mean Difference (Net)|0.7|||||TWO_SIDED|95.0|-1.5|2.9||||||||2.9|-1.5|
71699012|NCT02966834|142913562|OTHER||Mean Difference (Net)|-0.02|||||TWO_SIDED|95.0|-0.08|0.04||||||||0.04|-0.08|
71699013|NCT02966834|142913562|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.09|0.01||||||||0.01|-0.09|
71699014|NCT02966834|142913562|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.06|0.05||||||||0.05|-0.06|
71699015|NCT02966834|142913562|OTHER||Mean Difference (Net)|-0.03|||||TWO_SIDED|95.0|-0.09|0.02||||||||0.02|-0.09|
71699016|NCT02966834|142913562|OTHER||Mean Difference (Net)|-0.04|||||TWO_SIDED|95.0|-0.1|0.02||||||||0.02|-0.10|
71699017|NCT02966834|142913563|OTHER||Mean Difference (Net)|0.15|||||TWO_SIDED|95.0|-0.33|0.63||||||||0.63|-0.33|
71699018|NCT02966834|142913563|OTHER||Mean Difference (Net)|-0.11|||||TWO_SIDED|95.0|-0.51|0.3||||||||0.30|-0.51|
71699019|NCT02966834|142913563|OTHER||Mean Difference (Net)|0.12|||||TWO_SIDED|95.0|-0.34|0.58||||||||0.58|-0.34|
71699020|NCT02966834|142913563|OTHER||Mean Difference (Net)|-0.08|||||TWO_SIDED|95.0|-0.54|0.38||||||||0.38|-0.54|
71699021|NCT02966834|142913563|OTHER||Mean Difference (Net)|-0.07|||||TWO_SIDED|95.0|-0.54|0.41||||||||0.41|-0.54|
71699022|NCT02966834|142913573|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.69|12.02|||||Analysis was performed using Logistic regression. No covariates were used.|||12.02|0.69|
71699023|NCT02966834|142913573|OTHER||Odds Ratio (OR)|1.56|||||TWO_SIDED|95.0|0.48|5.02|||||Analysis was performed using Logistic regression. No covariates were used.|||5.02|0.48|
71699024|NCT02966834|142913573|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
71699025|NCT02966834|142913573|OTHER||Odds Ratio (OR)|3.0|||||TWO_SIDED|95.0|0.84|10.76|||||Analysis was performed using Logistic regression. No covariates were used.|||10.76|0.84|
71699026|NCT02966834|142913573|OTHER||Odds Ratio (OR)|1.33|||||TWO_SIDED|95.0|0.43|4.13|||||Analysis was performed using Logistic regression. No covariates were used.|||4.13|0.43|
71699027|NCT02966834|142913574|OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|95.0|0.41|4.47|||||Analysis was performed using Logistic regression. No covariates were used.|||4.47|0.41|
71699028|NCT02966834|142913574|OTHER||Odds Ratio (OR)|3.18|||||TWO_SIDED|95.0|0.95|10.65|||||Analysis was performed using Logistic regression. No covariates were used.|||10.65|0.95|
71699029|NCT02966834|142913574|OTHER||Odds Ratio (OR)|1.85|||||TWO_SIDED|95.0|0.62|5.53|||||Analysis was performed using Logistic regression. No covariates were used.|||5.53|0.62|
71699030|NCT02966834|142913574|OTHER||Odds Ratio (OR)|2.27|||||TWO_SIDED|95.0|0.74|6.92|||||Analysis was performed using Logistic regression. No covariates were used.|||6.92|0.74|
71699031|NCT02966834|142913574|OTHER||Odds Ratio (OR)|2.12|||||TWO_SIDED|95.0|0.69|6.51|||||Analysis was performed using Logistic regression. No covariates were used.|||6.51|0.69|
71699032|NCT02966834|142913575|OTHER||Odds Ratio (OR)|0.9|||||TWO_SIDED|95.0|0.27|3.04|||||Analysis was performed using Logistic regression. No covariates were used.|||3.04|0.27|
71699033|NCT02966834|142913575|OTHER||Odds Ratio (OR)|2.25|||||TWO_SIDED|95.0|0.73|6.91|||||Analysis was performed using Logistic regression. No covariates were used.|||6.91|0.73|
71699034|NCT02966834|142913575|OTHER||Odds Ratio (OR)|1.04|||||TWO_SIDED|95.0|0.35|3.08|||||Analysis was performed using Logistic regression. No covariates were used.|||3.08|0.35|
71699035|NCT02966834|142913575|OTHER||Odds Ratio (OR)|2.17|||||TWO_SIDED|95.0|0.73|6.42|||||Analysis was performed using Logistic regression. No covariates were used.|||6.42|0.73|
71699036|NCT02966834|142913575|OTHER||Odds Ratio (OR)|2.0|||||TWO_SIDED|95.0|0.67|5.99|||||Analysis was performed using Logistic regression. No covariates were used.|||5.99|0.67|
71699037|NCT02966834|142913576|OTHER||Mean Difference (Net)|18.21|||||TWO_SIDED|95.0|-2.59|39.0||||||||39.00|-2.59|
71699038|NCT02966834|142913576|OTHER||Mean Difference (Net)|11.05|||||TWO_SIDED|95.0|-7.42|29.53||||||||29.53|-7.42|
71699039|NCT02966834|142913576|OTHER||Mean Difference (Net)|18.44|||||TWO_SIDED|95.0|0.82|36.06||||||||36.06|0.82|
71699040|NCT02966834|142913576|OTHER||Mean Difference (Net)|25.48|||||TWO_SIDED|95.0|7.0|43.95||||||||43.95|7.00|
71699041|NCT02966834|142913576|OTHER||Mean Difference (Net)|13.26|||||TWO_SIDED|95.0|-5.47|31.99||||||||31.99|-5.47|
71699042|NCT02966834|142913577|OTHER||Mean Difference (Net)|14.99|||||TWO_SIDED|95.0|-5.13|35.1||||||||35.10|-5.13|
71699043|NCT02966834|142913577|OTHER||Mean Difference (Net)|6.97|||||TWO_SIDED|95.0|-10.9|24.84||||||||24.84|-10.90|
71699044|NCT02966834|142913577|OTHER||Mean Difference (Net)|11.78|||||TWO_SIDED|95.0|-5.27|28.82||||||||28.82|-5.27|
71699045|NCT02966834|142913577|OTHER||Mean Difference (Net)|21.83|||||TWO_SIDED|95.0|3.96|39.7||||||||39.70|3.96|
71699046|NCT02966834|142913577|OTHER||Mean Difference (Net)|21.58|||||TWO_SIDED|95.0|3.46|39.69||||||||39.69|3.46|
71699047|NCT02966834|142913578|OTHER||Mean Difference (Net)|6.15|||||TWO_SIDED|95.0|-14.76|27.06||||||||27.06|-14.76|
71699048|NCT02966834|142913578|OTHER||Mean Difference (Net)|7.26|||||TWO_SIDED|95.0|-11.32|25.84||||||||25.84|-11.32|
71699049|NCT02966834|142913578|OTHER||Mean Difference (Net)|9.13|||||TWO_SIDED|95.0|-8.59|26.85||||||||26.85|-8.59|
71699050|NCT02966834|142913578|OTHER||Mean Difference (Net)|19.94|||||TWO_SIDED|95.0|1.36|38.51||||||||38.51|1.36|
71699051|NCT02966834|142913578|OTHER||Mean Difference (Net)|27.04|||||TWO_SIDED|95.0|8.2|45.87||||||||45.87|8.20|
71699052|NCT02966834|142913579|OTHER||Mean Difference (Net)|-0.27|||||TWO_SIDED|95.0|-1.46|0.92||||||||0.92|-1.46|
71699053|NCT02966834|142913579|OTHER||Mean Difference (Net)|-0.48|||||TWO_SIDED|95.0|-1.58|0.62||||||||0.62|-1.58|
71699054|NCT02966834|142913579|OTHER||Mean Difference (Net)|-0.46|||||TWO_SIDED|95.0|-1.53|0.61||||||||0.61|-1.53|
71699055|NCT02966834|142913579|OTHER||Mean Difference (Net)|-0.96|||||TWO_SIDED|95.0|-2.03|0.12||||||||0.12|-2.03|
71699056|NCT02966834|142913579|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.4|0.8||||||||0.80|-1.40|
71699057|NCT02966834|142913580|OTHER||Mean Difference (Net)|-0.39|||||TWO_SIDED|95.0|-1.49|0.71||||||||0.71|-1.49|
71699058|NCT02966834|142913580|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.41|0.61||||||||0.61|-1.41|
71699059|NCT02966834|142913580|OTHER||Mean Difference (Net)|-0.26|||||TWO_SIDED|95.0|-1.24|0.72||||||||0.72|-1.24|
71699060|NCT02966834|142913580|OTHER||Mean Difference (Net)|-0.42|||||TWO_SIDED|95.0|-1.39|0.56||||||||0.56|-1.39|
71699061|NCT02966834|142913580|OTHER||Mean Difference (Net)|-0.29|||||TWO_SIDED|95.0|-1.28|0.7||||||||0.70|-1.28|
71699062|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.7|0.5|||||Duration|||0.5|-0.7|
71699063|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.4|||||TWO_SIDED|95.0|-0.2|0.9|||||Duration|||0.9|-0.2|
71699064|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.1|||||Duration|||0.1|-1.0|
71699065|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.2|||||TWO_SIDED|95.0|-0.3|0.7|||||Duration|||0.7|-0.3|
71699066|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.1|||||TWO_SIDED|95.0|-0.4|0.6|||||Duration|||0.6|-0.4|
71699067|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.3|||||Degree|||0.3|-0.8|
71699068|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.5|0.5|||||Degree|||0.5|-0.5|
71699069|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.5|||||Degree|||0.5|-0.6|
71699070|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Degree|||0.3|-0.7|
71699071|NCT02966834|142913581|OTHER||Median Difference (Net)|-0.1|||||TWO_SIDED|95.0|-0.6|0.4|||||Degree|||0.4|-0.6|
71699072|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.7|||||Direction|||0.7|-0.7|
71699073|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.7|0.6|||||Direction|||0.6|-0.7|
71699074|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Direction|||0.5|-0.8|
71699075|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.0|0.2|||||Direction|||0.2|-1.0|
71699076|NCT02966834|142913581|OTHER||Mean Difference (Net)|0.0|||||TWO_SIDED|95.0|-0.6|0.6|||||Direction|||0.6|-0.6|
71699077|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.4|||||TWO_SIDED|95.0|-1.1|0.3|||||Disability|||0.3|-1.1|
71699078|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.8|0.5|||||Disability|||0.5|-0.8|
71699079|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
71699080|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
71699081|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-1.0|0.3|||||Disability|||0.3|-1.0|
71699082|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.3|||||Distribution|||0.3|-0.9|
71699083|NCT02966834|142913581|OTHER||Median Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
71699084|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.5|||||TWO_SIDED|95.0|-1.0|0.0|||||Distribution|||0.0|-1.0|
71699085|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.3|||||TWO_SIDED|95.0|-0.9|0.2|||||Distribution|||0.2|-0.9|
71699086|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.2|||||TWO_SIDED|95.0|-0.7|0.3|||||Distribution|||0.3|-0.7|
71699087|NCT02966834|142913581|OTHER||Mean Difference (Net)|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||5-D Itch Total Score|||1.3|-3.3|
71699088|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.1|||||TWO_SIDED|95.0|-2.2|2.1|||||5-D Itch Total Score|||2.1|-2.2|
71699089|NCT02966834|142913581|OTHER||Mean Difference (Net)|-1.4|||||TWO_SIDED|95.0|-3.5|0.7|||||5-D Itch Total Score|||0.7|-3.5|
71699090|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-3.0|1.2|||||5-D Itch Total Score|||1.2|-3.0|
71699091|NCT02966834|142913581|OTHER||Mean Difference (Net)|-0.6|||||TWO_SIDED|95.0|-2.7|1.6|||||5-D Itch Total Score|||1.6|-2.7|
71699092|NCT02966834|142913585|OTHER||Mean Difference (Net)|-0.71|||||TWO_SIDED|95.0|-1.69|0.28||||||||0.28|-1.69|
71699093|NCT02966834|142913585|OTHER||Mean Difference (Net)|-0.62|||||TWO_SIDED|95.0|-1.49|0.26||||||||0.26|-1.49|
71699094|NCT02966834|142913585|OTHER||Mean Difference (Net)|-0.9|||||TWO_SIDED|95.0|-1.76|-0.03||||||||-0.03|-1.76|
71699095|NCT02966834|142913585|OTHER||Mean Difference (Net)|-1.16|||||TWO_SIDED|95.0|-2.05|-0.28||||||||-0.28|-2.05|
71699096|NCT02966834|142913585|OTHER||Mean Difference (Net)|-0.95|||||TWO_SIDED|95.0|-1.85|-0.06||||||||-0.06|-1.85|
71699097|NCT02966834|142913586|OTHER||Least Square (LS) mean ratio|0.967|||||TWO_SIDED|95.0|0.635|1.471||||||||1.471|0.635|
71699098|NCT02966834|142913586|OTHER||LS mean ratio|1.17|||||TWO_SIDED|95.0|0.8|1.712||||||||1.712|0.8|
71699099|NCT02966834|142913586|OTHER||LS mean ratio|0.909|||||TWO_SIDED|95.0|0.627|1.316||||||||1.316|0.627|
71699100|NCT02966834|142913586|OTHER||LS mean ratio|0.69|||||TWO_SIDED|95.0|0.474|1.005||||||||1.005|0.474|
71699101|NCT02966834|142913586|OTHER||LS mean ratio|0.825|||||TWO_SIDED|95.0|0.564|1.207||||||||1.207|0.564|
71699102|NCT02966834|142913587|OTHER||LS mean ratio|1.363|||||TWO_SIDED|95.0|0.932|1.995||||||||1.995|0.932|
71699103|NCT02966834|142913587|OTHER||LS mean ratio|2.05|||||TWO_SIDED|95.0|1.456|2.887||||||||2.887|1.456|
71699104|NCT02966834|142913587|OTHER||LS mean ratio|2.457|||||TWO_SIDED|95.0|1.758|3.436||||||||3.436|1.758|
71699105|NCT02966834|142913587|OTHER||LS mean ratio|3.128|||||TWO_SIDED|95.0|2.206|4.435||||||||4.435|2.206|
71699106|NCT02966834|142913587|OTHER||LS mean ratio|2.701|||||TWO_SIDED|95.0|1.915|3.81||||||||3.81|1.915|
71699107|NCT01773928|142913657|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|The probability that the modified process is noninferior to the current one (i.e. lower limit of the 95% CI of the ratio of geometric means \[modified vs. current\] is greater than or equal to 0.67) is above 99% for one strain, and it is around 97% for all three strains (considering the three strains to be independent, 0.99 x 0.99 x 0.99=0.97)|ANCOVA|0.67|||||ONE_SIDED|95.0|0.67||||||||||0.67|
71699108|NCT01773928|142913659|SUPERIORITY_OR_OTHER_LEGACY||ANCOVA|0.67|||||TWO_SIDED|95.0|0.67|1.5||||||"The overall power to prove the similarity between the three lots for all three strains is approximately 99%.~For the two primary co-analyses (Noninferiority and Lot Consistency), the overall power of the immunogenicity analyses is approximately 96% (calculated as 0.97 x 0.99=0.96)."||1.5|0.67|
71699109|NCT01773928|142913660|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|"Differences between fever incidences (95% CI) between treatment groups VCIV Modified (Total) and TIV was computed for each age cohort separately. The Confidence Interval estimation method was the method of Miettinen \& Nurminen, as described in the StatXact User Manual (i.e. the score statistics, also called Chan's method, page 283).~Noninferiority will be concluded if the upper limit of the 95% CI (VCIV modified-TIV) is \<5%."|Method of Miettinen & Nurminen|1.8||||||95.0|0.1|3.3||||||||3.3|0.1|
71699110|NCT02431299|142913671|SUPERIORITY_OR_OTHER||||||<|0.01|TWO_SIDED|||||Whether there were significant changes in the IMRS baseline scores to IMRS follow up scores.|t-test, 2 sided|t = 2.78, df = 182||||||<0.01
71699111|NCT02431299|142913672|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||Regression, Linear|||Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.||||<0.05
71699112|NCT03729362|142913691|SUPERIORITY|Analysis used a mixed-effect model for repeated measures (MMRM). The model included terms for treatment, baseline 6MWD, age, height, weight (all as continuous covariates), enzyme replacement therapy (ERT) status (ERT-naïve versus ERT-experienced), gender, time, and treatment-by-time interaction. Time was used as a repeated measure, and an unstructured covariance approach was applied.|LS Mean Difference|14.21|STANDARD_ERROR_OF_MEAN|8.481||0.048|TWO_SIDED|95.0|-2.6|31.02||1-sided significance level of 0.025.|MMRM|||"The primary and key secondary endpoints were tested in hierarchical order as follows:~The test for the primary endpoint was conducted first at the 1-sided 0.025 significance level, and if significant, the ordered key secondary endpoints were similarly tested. If at any point the null hypothesis for superiority failed to be rejected, then that comparison and any other comparison below it could not be claimed as successful and would be considered nominal."||31.02|-2.6|0.048
71699113|NCT03729362|142913692|SUPERIORITY|The analysis used an Analysis of Covariance (ANCOVA) model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|2.66|STANDARD_ERROR_OF_MEAN|1.156||0.012|TWO_SIDED|95.0|0.37|4.95||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in sitting FVC was the first of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||4.95|0.37|0.012
71699114|NCT03729362|142913693|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.96|STANDARD_ERROR_OF_MEAN|0.727||0.095|TWO_SIDED|95.0|-0.48|2.4||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the MMT score for the lower extremities was the second of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.4|-0.48|0.095
71699115|NCT03729362|142913694|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|8.17|STANDARD_ERROR_OF_MEAN|6.261||0.097|TWO_SIDED|95.0|-4.24|20.57||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 26 in 6MWD was the third of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||20.57|-4.24|0.097
71699116|NCT03729362|142913695|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|1.87|STANDARD_ERROR_OF_MEAN|1.706||0.138|TWO_SIDED|95.0|-1.51|5.25||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Physical Function was the fourth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||5.25|-1.51|0.138
71699117|NCT03729362|142913696|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|0.04|STANDARD_ERROR_OF_MEAN|1.092||0.515|TWO_SIDED|95.0|-2.12|2.2||1-sided significance level of 0.025|ANCOVA|||Change from baseline to Week 52 in the total score for the PROMIS® - Fatigue was the fifth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||2.2|-2.12|0.515
71699118|NCT03729362|142913697|SUPERIORITY|The analysis used an ANCOVA model adjusted for the baseline value (as a continuous covariate) and ERT status (ERT-naïve versus ERT-experienced), as well as baseline age, gender, baseline height, and baseline weight.|LS Mean Difference|-1.414|STANDARD_ERROR_OF_MEAN|0.528||0.004|TWO_SIDED|95.0|-2.463|-0.364||1-sided significance level of 0.025.|ANCOVA|||Change from baseline to Week 52 in the total score for the GSGC was the sixth of 6 key secondary efficacy endpoints, which were analyzed according to a hierarchical order.||-0.364|-2.463|0.004
71699119|NCT00362232|142913727|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.71|||<|0.001||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.17|-5.25|<0.001
71699120|NCT00362232|142913727|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.71||||0.036||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences||Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.17|-5.25|0.036
71699121|NCT00362232|142913728|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-3.19||||0.012||95.0|-5.67|-0.71|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).||-0.71|-5.67|0.012
71699122|NCT00362232|142913729|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.37||||0.456||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.6|-1.34|0.456
71699123|NCT00362232|142913729|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.37|||<|0.001||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.6|-1.34|<0.001
71699124|NCT00362232|142913730|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.8||||0.124||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.22|-1.82|0.124
71699125|NCT00362232|142913730|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.8|||<|0.001||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.22|-1.82|<0.001
71699126|NCT00362232|142913731|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.44||||||95.0|-1.59|0.66|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.66|-1.59|
71699127|NCT00362232|142913732|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.72||||||95.0|-1.81|0.36|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.36|-1.81|
71699128|NCT00362232|142913733|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.38||||||95.0|-4.84|0.07|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.07|-4.84|
71699129|NCT00362232|142913734|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.67||||||95.0|-5.02|-0.32|||||Mantel-Haenszel weighted difference to Enoxaparin|||-0.32|-5.02|
71699130|NCT00362232|142913735|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.24||||||95.0|-0.22|0.71|||||Mantel-Haenszel weighted difference to Enoxaparin|||0.71|-0.22|
71699131|NCT00362232|142913736|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.11||||||95.0|-0.35|0.56||||||||0.56|-0.35|
71699132|NCT00362232|142913737|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.3||||||95.0|-1.56|0.94|||||Exact methods for difference to Enoxaparin|||0.94|-1.56|
71699133|NCT00362232|142913738|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.47||||0.054||95.0|-4.99|0.04|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.04|-4.99|0.054
71699134|NCT00362232|142913738|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.47|||<|0.001||95.0|-4.49|0.04|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||0.04|-4.49|<0.001
71699135|NCT00362232|142913739|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-2.97||||0.017||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||-0.53|-5.42|0.017
71699136|NCT00362232|142913739|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.97|||<|0.001||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.||-0.53|-5.42|<0.001
71699137|NCT00362232|142913740|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.57||||0.27||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.44|-1.57|0.270
71699138|NCT00362232|142913740|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.57|||<|0.001||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.44|-1.57|<0.001
71699139|NCT00362232|142913741|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.98||||0.074||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.10|-2.06|0.074
71699140|NCT00362232|142913741|NON_INFERIORITY_OR_EQUIVALENCE|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .|Risk Difference (RD)|-0.98|||<|0.001||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.||0.10|-2.06|<0.001
71699141|NCT00362232|142913742|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.39||||0.11||95.0|-0.09|0.88|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)||0.88|-0.09|0.110
71699142|NCT02314546|142913743|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
71699143|NCT02314546|142913744|SUPERIORITY_OR_OTHER|||||||0.99|TWO_SIDED||||||Chi-squared|||||||0.99
71699144|NCT02314546|142913745|SUPERIORITY_OR_OTHER|||||||0.26|TWO_SIDED||||||Kruskal-Wallis|||||||0.26
71699145|NCT02314546|142913746|SUPERIORITY_OR_OTHER|||||||0.02|TWO_SIDED||||||Kruskal-Wallis|||||||0.02
71699146|NCT02314546|142913747|SUPERIORITY_OR_OTHER|||||||0.04|TWO_SIDED||||||Kruskal-Wallis|||||||0.04
71699147|NCT02314546|142913748|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
71699148|NCT02314546|142913749|SUPERIORITY_OR_OTHER|||||||0.73|TWO_SIDED||||||Chi-squared|||||||0.73
71699149|NCT00375752|142913750|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|14.7||||0.106|TWO_SIDED|95.0|-1.8|31.1|||Fisher Exact|||||31.1|-1.8|0.106
71699150|NCT00576758|142913774|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.26||||0.1587|TWO_SIDED|60.0|3.9|18.7|||Chi-squared|||||18.7|3.9|0.1587
71699151|NCT00576758|142913775|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.83|||||TWO_SIDED|95.0|-2.9|16.6||||||||16.6|-2.9|
71699152|NCT00576758|142913779|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.22|||||TWO_SIDED|95.0|-13.9|18.3||||||||18.3|-13.9|
71699153|NCT00576758|142913780|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.93|||||TWO_SIDED|95.0|0.62|1.44||||||||1.44|0.62|
71699154|NCT00576758|142913782|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.0|||||TWO_SIDED|95.0|0.67|1.5||||||||1.50|0.67|
71699155|NCT01499511|142913817|SUPERIORITY|||||||0.624|||||||ANOVA|||||||0.624
71699156|NCT01499511|142913818|SUPERIORITY|||||||0.004|||||||ANOVA|||||||0.004
71699157|NCT01499511|142913819|SUPERIORITY|||||||0.304|||||||ANOVA|||||||0.304
71699158|NCT01499511|142913820|SUPERIORITY|||||||0.641|||||||ANOVA|||||||0.641
71699159|NCT01499511|142913821|SUPERIORITY|||||||0.915|||||||ANOVA|||||||0.915
71699160|NCT00853385|142913835|SUPERIORITY_OR_OTHER||Percent difference|24.24|||<|0.0001|TWO_SIDED|95.0|13.18|35.31||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.||35.31|13.18|<0.0001
71699161|NCT00853385|142913835|SUPERIORITY_OR_OTHER||Percent difference|23.22|||<|0.0001|TWO_SIDED|95.0|12.16|34.29||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||34.29|12.16|<0.0001
71699162|NCT00853385|142913835|SUPERIORITY_OR_OTHER||Percent difference|18.93||||0.0007|TWO_SIDED|95.0|7.9|29.96||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||29.96|7.90|0.0007
71699163|NCT00853385|142913836|SUPERIORITY_OR_OTHER||LS mean difference|-0.38|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED|95.0|-0.5|-0.25||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.25|-0.50|<0.0001
71699164|NCT00853385|142913836|SUPERIORITY_OR_OTHER||LS mean difference|-0.31|||<|0.0001|TWO_SIDED|95.0|-0.43|-0.19||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.19|-0.43|<0.0001
71699165|NCT00853385|142913836|SUPERIORITY_OR_OTHER||LS mean difference|-0.25|||<|0.0001|TWO_SIDED|95.0|-0.37|-0.13||Statistical testing was done at 5% significance level (2-sided).|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.||-0.13|-0.37|<0.0001
71699166|NCT00853385|142913837|SUPERIORITY_OR_OTHER||Percent difference|11.41|||<|0.0001|TWO_SIDED|95.0|6.08|16.73||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.||16.73|6.08|<0.0001
71699167|NCT00853385|142913837|SUPERIORITY_OR_OTHER||Percent difference|5.12||||0.0151|TWO_SIDED|95.0|0.98|9.26||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.26|0.98|0.0151
71699168|NCT00853385|142913837|SUPERIORITY_OR_OTHER||Percent difference|5.65||||0.0091|TWO_SIDED|95.0|1.4|9.9||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.||9.90|1.40|0.0091
71699169|NCT01107015|142913925|OTHER|Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10.||||||0.027||||||CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months.|Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation.||||0.027
71699170|NCT01107015|142913925|SUPERIORITY||Mean Difference (Net)|0.05||||0.001|TWO_SIDED||||||Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin.||||0.001
71699171|NCT03104413|142913926|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
71699172|NCT03104413|142913926|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|< 0.001
71699173|NCT03104413|142913927|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|< 0.001
71699174|NCT03104413|142913927|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
71699175|NCT03104413|142913928|SUPERIORITY||Adjusted Risk Difference|17.6|||<|0.001|TWO_SIDED|95.0|9.9|25.4|||Cochran-Mantel-Haenszel|||||25.4|9.9|<0.001
71699176|NCT03104413|142913928|SUPERIORITY||Adjusted Risk Difference|23.1|||<|0.001|TWO_SIDED|95.0|15.1|31.1|||Cochran-Mantel-Haenszel|||||31.1|15.1|<0.001
71699177|NCT03104413|142913929|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24.0|6.4|0.001
71699178|NCT03104413|142913929|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
71699179|NCT03104413|142913930|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
71699180|NCT03104413|142913930|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3.0|0.008
71699181|NCT03104413|142913931|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|< 0.001
71699182|NCT03104413|142913931|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
71699183|NCT03104413|142913932|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
71699184|NCT03104413|142913932|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
71699185|NCT03104413|142913933|SUPERIORITY||Adjusted Risk Difference|9.6||||0.01|TWO_SIDED|95.0|2.3|16.9|||Cochran-Mantel-Haenszel|||||16.9|2.3|0.010
71699186|NCT03104413|142913933|SUPERIORITY||Adjusted Risk Difference|8.2||||0.023|TWO_SIDED|95.0|1.1|15.3|||Cochran-Mantel-Haenszel|||||15.3|1.1|0.023
71699187|NCT03104413|142913934|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.5|21.5|||Cochran-Mantel-Haenszel|||||21.5|8.5|<0.001
71699188|NCT03104413|142913934|SUPERIORITY||Adjusted Risk Difference|17.8|||<|0.001|TWO_SIDED|95.0|11.1|24.5|||Cochran-Mantel-Haenszel|||||24.5|11.1|<0.001
71699189|NCT03104413|142913935|SUPERIORITY||Adjusted Risk Difference|17.5|||<|0.001|TWO_SIDED|95.0|8.0|26.9|||Cochran-Mantel-Haenszel|||||26.9|8.0|<0.001
71699190|NCT03104413|142913935|SUPERIORITY||Adjusted Risk Difference|20.3|||<|0.001|TWO_SIDED|95.0|10.8|29.8|||Cochran-Mantel-Haenszel|||||29.8|10.8|<0.001
71699191|NCT03104413|142913936|SUPERIORITY||Adjusted Risk Difference|21.8|||<|0.001|TWO_SIDED|95.0|12.1|31.6|||Cochran-Mantel-Haenszel|||||31.6|12.1|<0.001
71699192|NCT03104413|142913936|SUPERIORITY||Adjusted Risk Difference|22.7|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
71699193|NCT03104413|142913937|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
71699194|NCT03104413|142913937|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
71699195|NCT03104413|142913938|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4.0|0.006
71699196|NCT03104413|142913938|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
71699197|NCT03104413|142913939|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
71699198|NCT03104413|142913939|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
71699199|NCT03104413|142913940|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
71699200|NCT03104413|142913940|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
71699201|NCT03104413|142913941|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
71699202|NCT03104413|142913941|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
71699203|NCT03104413|142913942|SUPERIORITY||Risk Difference (RD)|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Chi-squared|||||-2.9|-13.2|0.002
71699204|NCT03104413|142913942|SUPERIORITY||Risk Difference (RD)|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Chi-squared|||||-4.2|-14.1|<0.001
71699205|NCT03104413|142913943|SUPERIORITY||Risk Difference (RD)|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Chi-squared|||||15.7|-28.1|1
71699206|NCT03104413|142913943|SUPERIORITY||Risk Difference (RD)|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Chi-squared|||||60.2|0.6|0.113
71699207|NCT03104413|142913944|SUPERIORITY||Adjusted Risk Difference|22.1|||<|0.001|TWO_SIDED|95.0|13.1|31.0|||Cochran-Mantel-Haenszel|||||31.0|13.1|<0.001
71699208|NCT03104413|142913944|SUPERIORITY||Adjusted Risk Difference|20.5|||<|0.001|TWO_SIDED|95.0|11.6|29.5|||Cochran-Mantel-Haenszel|||||29.5|11.6|<0.001
71699209|NCT03104413|142913945|SUPERIORITY||Adjusted Risk Difference|15.7||||0.001|TWO_SIDED|95.0|6.8|24.6|||Cochran-Mantel-Haenszel|||||24.6|6.8|0.001
71699210|NCT03104413|142913945|SUPERIORITY||Adjusted Risk Difference|11.8||||0.008|TWO_SIDED|95.0|3.0|20.5|||Cochran-Mantel-Haenszel|||||20.5|3|0.008
71699211|NCT03104413|142913946|SUPERIORITY||Adjusted Risk Difference|9.2||||0.006|TWO_SIDED|95.0|2.6|15.7|||Cochran-Mantel-Haenszel|||||15.7|2.6|0.006
71699212|NCT03104413|142913946|SUPERIORITY||Adjusted Risk Difference|10.3||||0.002|TWO_SIDED|95.0|3.7|16.8|||Cochran-Mantel-Haenszel|||||16.8|3.7|0.002
71699213|NCT03104413|142913947|SUPERIORITY||Adjusted Risk Difference|29.4|||<|0.001|TWO_SIDED|95.0|19.9|39.0|||Cochran-Mantel-Haenszel|||||39.0|19.9|<0.001
71699214|NCT03104413|142913947|SUPERIORITY||Adjusted Risk Difference|30.6|||<|0.001|TWO_SIDED|95.0|21.1|40.1|||Cochran-Mantel-Haenszel|||||40.1|21.1|<0.001
71699215|NCT03104413|142913948|SUPERIORITY||LS Mean Difference|2.8||||0.02|TWO_SIDED|95.0|0.4|5.1|||Mixed-Effect Model Repeat Measurement|||||5.1|0.4|0.020
71699216|NCT03104413|142913948|SUPERIORITY||LS Mean Difference|3.0||||0.01|TWO_SIDED|95.0|0.7|5.3|||Mixed-Effect Model Repeat Measurement|||||5.3|0.7|0.010
71699217|NCT03104413|142913949|SUPERIORITY||LS Mean Difference|12.4||||0.001|TWO_SIDED|95.0|5.0|19.8|||Mixed-Effect Model Repeat Measurement|||||19.8|5.0|0.001
71699218|NCT03104413|142913949|SUPERIORITY||LS Mean Difference|15.0|||<|0.001|TWO_SIDED|95.0|7.7|22.4|||Mixed-Effect Model Repeat Measurement|||||22.4|7.7|<0.001
71699219|NCT03104413|142913950|SUPERIORITY||Adjusted Risk Difference|13.9|||<|0.001|TWO_SIDED|95.0|7.1|20.7|||Cochran-Mantel-Haenszel|||||20.7|7.1|<0.001
71699220|NCT03104413|142913950|SUPERIORITY||Adjusted Risk Difference|17.3|||<|0.001|TWO_SIDED|95.0|10.3|24.2|||Cochran-Mantel-Haenszel|||||24.2|10.3|<0.001
71699221|NCT03104413|142913951|SUPERIORITY||Adjusted Risk Difference|15.0|||<|0.001|TWO_SIDED|95.0|8.9|21.2|||Cochran-Mantel-Haenszel|||||21.2|8.9|<0.001
71699222|NCT03104413|142913951|SUPERIORITY||Adjusted Risk Difference|16.2|||<|0.001|TWO_SIDED|95.0|9.9|22.4|||Cochran-Mantel-Haenszel|||||22.4|9.9|<0.001
71699223|NCT03104413|142913952|SUPERIORITY||Adjusted Risk Difference|13.6||||0.006|TWO_SIDED|95.0|4.0|23.3|||Cochran-Mantel-Haenszel|||||23.3|4|0.006
71699224|NCT03104413|142913952|SUPERIORITY||Adjusted Risk Difference|7.1||||0.142|TWO_SIDED|95.0|-2.4|16.6|||Cochran-Mantel-Haenszel|||||16.6|-2.4|0.142
71699225|NCT03104413|142913953|SUPERIORITY||Adjusted Risk Difference|9.4||||0.001|TWO_SIDED|95.0|3.8|15.1|||Cochran-Mantel-Haenszel|||||15.1|3.8|0.001
71699226|NCT03104413|142913953|SUPERIORITY||Adjusted Risk Difference|11.2|||<|0.001|TWO_SIDED|95.0|5.3|17.0|||Cochran-Mantel-Haenszel|||||17.0|5.3|<0.001
71699227|NCT03104413|142913954|SUPERIORITY||Adjusted Risk Difference|22.8|||<|0.001|TWO_SIDED|95.0|13.0|32.5|||Cochran-Mantel-Haenszel|||||32.5|13.0|<0.001
71699228|NCT03104413|142913954|SUPERIORITY||Adjusted Risk Difference|20.0|||<|0.001|TWO_SIDED|95.0|10.2|29.9|||Cochran-Mantel-Haenszel|||||29.9|10.2|<0.001
71699229|NCT03104413|142913955|SUPERIORITY||Adjusted Risk Difference|5.6||||0.377|TWO_SIDED|95.0|-6.8|17.9|||Cochran-Mantel-Haenszel|||||17.9|-6.8|0.377
71699230|NCT03104413|142913955|SUPERIORITY||Adjusted Risk Difference|13.4||||0.039|TWO_SIDED|95.0|0.7|26.1|||Cochran-Mantel-Haenszel|||||26.1|0.7|0.039
71699231|NCT03104413|142913956|SUPERIORITY||LS Mean Difference|-8.1||||0.002|TWO_SIDED|95.0|-13.2|-2.9|||Mixed-Effect Model Repeat Measurement|||||-2.9|-13.2|0.002
71699232|NCT03104413|142913956|SUPERIORITY||LS Mean Difference|-9.1|||<|0.001|TWO_SIDED|95.0|-14.1|-4.2|||Mixed-Effect Model Repeat Measurement|||||-4.2|-14.1|<0.001
71699233|NCT03104413|142913957|SUPERIORITY||LS Mean Difference|-6.2||||1|TWO_SIDED|95.0|-28.1|15.7|||Mixed-Effect Model Repeat Measurement|||||15.7|-28.1|1.00
71699234|NCT03104413|142913957|SUPERIORITY||LS Mean Difference|30.4||||0.113|TWO_SIDED|95.0|0.6|60.2|||Mixed-Effect Model Repeat Measurement|||||60.2|0.6|0.113
71699235|NCT03104413|142913958|SUPERIORITY||LS Mean Difference|-7.323||||0.113|TWO_SIDED|95.0|-16.399|1.753|||Mixed-Effect Model Repeat Measurement|||||1.753|-16.399|0.113
71699236|NCT03104413|142913958|SUPERIORITY||LS Mean Difference|-8.759||||0.05|TWO_SIDED|95.0|-17.518|-0.001|||Mixed-Effect Model Repeat Measurement|||||-0.001|-17.518|0.050
71699237|NCT03104413|142913959|SUPERIORITY||LS Mean Difference|2.221||||0.008|TWO_SIDED|95.0|0.577|3.865|||Mixed-Effect Model Repeat Measurement|||||3.865|0.577|0.008
71699238|NCT03104413|142913959|SUPERIORITY||LS Mean Difference|2.714||||0.001|TWO_SIDED|95.0|1.077|4.351|||Mixed-Effect Model Repeat Measurement|||||4.351|1.077|0.001
71699239|NCT03104413|142913960|SUPERIORITY||Adjusted Risk Difference|15.2||||0.001|TWO_SIDED|95.0|6.4|24.0|||Cochran-Mantel-Haenszel|||||24|6.4|0.001
71699240|NCT03104413|142913960|SUPERIORITY||Adjusted Risk Difference|20.4|||<|0.001|TWO_SIDED|95.0|11.5|29.3|||Cochran-Mantel-Haenszel|||||29.3|11.5|<0.001
71699241|NCT02765035|142913961|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||C-Leg 3 vs. NMPK (Baseline)||||0.01
71699242|NCT02765035|142913961|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||C-Leg 4 vs. NMPK (Baseline)||||0.04
71699243|NCT00984867|142913980|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.48|STANDARD_ERROR_OF_MEAN|0.072|<|0.0001|TWO_SIDED|95.0|-0.62|-0.34||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary \& key secondary objectives, based on data from both strata combined|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.34|-0.62|<0.0001
71699244|NCT00984867|142913981|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.89|STANDARD_ERROR_OF_MEAN|0.2466|<|0.0001|TWO_SIDED|95.0|-2.37|-1.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-1.40|-2.37|<0.0001
71699245|NCT00984867|142913982|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.83|STANDARD_ERROR_OF_MEAN|0.1106|<|0.0001|TWO_SIDED|95.0|-1.05|-0.62||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-0.62|-1.05|<0.0001
71699246|NCT00984867|142913983|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-27.92|STANDARD_ERROR_OF_MEAN|3.32|<|0.0001|TWO_SIDED|95.0|-34.45|-21.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-21.40|-34.45|<0.0001
71699247|NCT00984867|142913984|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.86|STANDARD_ERROR_OF_MEAN|1.4659||0.5583||95.0|-3.75|2.03||Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||2.03|-3.75|0.5583
71699248|NCT00984867|142913985|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.82|STANDARD_ERROR_OF_MEAN|3.516|||TWO_SIDED|95.0|-21.73|-7.9||Not significant. Hierarchical testing procedure stopped at previous endpoint|ANCOVA|with treatment group and stratum as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group||-7.90|-21.73|
71699249|NCT00984867|142913986|SUPERIORITY_OR_OTHER||Risk Difference (RD)|18.7|STANDARD_ERROR_OF_MEAN|41.2|||TWO_SIDED|95.0|11.1|26.4||Not significant. Hierarchical testing procedure stopped at previous endpoint|Regression, Logistic|Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value and stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0.||26.4|11.1|
71699250|NCT01206764|142914011|OTHER|Kaplan Meier|Median Difference (Net)|27.71|||||TWO_SIDED|95.0|21.86|35.29||||||Single arm open label study||35.29|21.86|
71699251|NCT01206764|142914015|OTHER|Kaplan Meier|Median Difference (Net)|45.71|||||TWO_SIDED|95.0|31.29|106.43||||||The median overall survival was not evaluable, this presents the 25th percentile of overall survival||106.43|31.29|
71699252|NCT05824026|142914074|OTHER||||||||||||||||||"The purpose of the primary analysis was to show non-inferiority to the performance of a historical control (a silver containing gelling fiber) on proportion of wounds healed, 77%, with a non-inferiority margin of 20%. Non-inferiority was demonstrated if the lower limit of the 95% confidence interval is above 57%. An exact confidence interval for the proportion was applied. In the primary analysis missing data was not included. In the post hoc sensitivity analysis missing data was imputed using multiple imputation for 3 wounds where data was assumed to be missing at random, and otherwise imputed as wound not healed.~The supplemental analysis addressed a more conservative analysis than performed for the historical control. Hence, no formal non-inferiority criteria was applied for this analysis."|||
71699253|NCT03692312|142914080|SUPERIORITY||Mean Difference (Final Values)|1.75|STANDARD_ERROR_OF_MEAN|0.875||0.0514|TWO_SIDED|95.0|-0.01|3.51|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||3.51|-0.01|0.0514
71699254|NCT03692312|142914081|SUPERIORITY||Mean Difference (Final Values)|0.34|STANDARD_ERROR_OF_MEAN|0.268||0.2124|TWO_SIDED|95.0|-0.2|0.88|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.88|-0.20|0.2124
71699255|NCT03692312|142914082|SUPERIORITY||Mean Difference (Final Values)|4.74|STANDARD_ERROR_OF_MEAN|1.104|<|0.0001|TWO_SIDED|95.0|2.51|6.96|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||6.96|2.51|<0.0001
71699256|NCT03692312|142914083|SUPERIORITY||Mean Difference (Final Values)|3.18|STANDARD_ERROR_OF_MEAN|1.099||0.0059|TWO_SIDED|95.0|0.96|5.39|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||5.39|0.96|0.0059
71699257|NCT03692312|142914084|SUPERIORITY||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.108||0.4634|TWO_SIDED|95.0|-0.3|0.14|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.14|-0.30|0.4634
71699258|NCT03692312|142914085|SUPERIORITY||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.564||0.5385|TWO_SIDED|95.0|-1.49|0.79|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.79|-1.49|0.5385
71699259|NCT03692312|142914088|SUPERIORITY||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|0.764||0.711|TWO_SIDED|95.0|-1.26|1.83|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||1.83|-1.26|0.7110
71699260|NCT03692312|142914089|SUPERIORITY||Mean Difference (Final Values)|0.09|STANDARD_ERROR_OF_MEAN|0.326||0.7861|TWO_SIDED|95.0|-0.57|0.75|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.75|-0.57|0.7861
71699261|NCT03692312|142914090|SUPERIORITY||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.123||0.6282|TWO_SIDED|95.0|-0.19|0.31|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. A compound symmetry variance-covariance matrix has been used.||0.31|-0.19|0.6282
71699262|NCT03692312|142914091|SUPERIORITY|||||||0.0428|||||||t-test, 2 sided|||||||0.0428
71699263|NCT03692312|142914092|SUPERIORITY||Ratio|0.77|STANDARD_ERROR_OF_MEAN|0.094||0.0379|TWO_SIDED|95.0|0.6|0.98|||MMRM|||Analysis is a mixed model for repeated measures (MMRM) analysis with treatment, visit, age group and treatment by visit interaction as fixed effects and baseline value as a covariate. An unstructured variance-covariance matrix has been used.||0.98|0.60|0.0379
71699264|NCT03692312|142914094|SUPERIORITY|||||||0.078|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.078
71699265|NCT03692312|142914096|SUPERIORITY|||||||0.29|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline; two-tailed t-test assuming unequal variance.||||0.29
71699266|NCT03692312|142914098|SUPERIORITY|||||||0.077|||||||t-test, 2 sided|||Cmax upper quantiles group compared to the placebo group for mean change from baseline (absolute value); two-tailed t-test assuming unequal variance.||||0.077
71699267|NCT03692312|142914099|SUPERIORITY|||||||0.071|||||||t-test, 2 sided|||Cmax upper quantiles group compared to placebo group for mean Raw Score; two-tailed t-test assuming unequal variance.||||0.071
71699268|NCT05033041|142914134|EQUIVALENCE|Equivalence is based on an equivalence hypothesis of -17mL \<difference in differences \< 17mL.||||||0.001|||||||t-test, 1 sided|||Comparison of the means using two one-sided t tests (TOST)||||.001
71699269|NCT05233761|142914158|SUPERIORITY|The mean nightly difference in SWS + REM sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.6||0.035|TWO_SIDED|95.0|0.1|2.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.5|0.1|0.0350
71699270|NCT05233761|142914159|SUPERIORITY|The mean nightly difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.0|STANDARD_ERROR_OF_MEAN|0.3||0.0019|TWO_SIDED|95.0|0.4|1.6|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.6|0.4|0.0019
71699271|NCT05233761|142914159|SUPERIORITY|The mean nightly difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.4||0.52|TWO_SIDED|95.0|-0.6|1.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||1.2|-.6|0.52
71699272|NCT05233761|142914159|SUPERIORITY|The mean nightly difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-1.7|STANDARD_ERROR_OF_MEAN|0.6||0.004|TWO_SIDED|95.0|-2.8|-0.5|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (% TST) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||-0.5|-2.8|0.0040
71699273|NCT05233761|142914159|SUPERIORITY|The mean nightly difference in Awake Time (% TST) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.24|TWO_SIDED|95.0|-0.5|2.0|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (% TST) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.0|-.5|0.24
71699274|NCT05233761|142914160|SUPERIORITY|The mean nightly difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|4.9|STANDARD_ERROR_OF_MEAN|2.6||0.0117|TWO_SIDED|95.0|1.7|13.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS + REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||13.3|1.7|0.0117
71699275|NCT05233761|142914160|SUPERIORITY|The mean nightly difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|3.3|STANDARD_ERROR_OF_MEAN|1.3||0.0126|TWO_SIDED|95.0|0.7|5.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in SWS Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.9|0.7|0.0126
71699276|NCT05233761|142914160|SUPERIORITY|The mean nightly difference in REM sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|2.0||0.51|TWO_SIDED|95.0|-2.7|5.3|||t-test, 2 sided|||The null hypothesis was that there was no difference in REM Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||5.3|-2.7|0.51
71699277|NCT05233761|142914160|SUPERIORITY|The mean nightly difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.8|STANDARD_ERROR_OF_MEAN|3.6||0.0574|TWO_SIDED|95.0|-13.7|0.2|||t-test, 2 sided|||The null hypothesis was that there was no difference in Light Sleep (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||0.2|-13.7|0.0574
71699278|NCT05233761|142914160|SUPERIORITY|The mean nightly difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|2.4||0.3|TWO_SIDED|95.0|-2.4|6.9|||t-test, 2 sided|||The null hypothesis was that there was no difference in Awake Time (min) in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||6.9|-2.4|0.3
71699279|NCT05233761|142914160|SUPERIORITY|The mean nightly difference in Total Sleep Time (min) in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment difference in percentages was estimated and constructed using the above-mentioned method.|Mean Difference (Final Values)|-6.9|STANDARD_ERROR_OF_MEAN|4.7||0.14|TWO_SIDED|95.0|-16.1|2.4|||t-test, 2 sided|||The null hypothesis was that there was no difference in Total Sleep Time (min) sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups.||2.4|-16.1|0.14
71699280|NCT05233761|142914161|SUPERIORITY|"The mean nightly difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.3|STANDARD_ERROR_OF_MEAN|0.5||0.53|TWO_SIDED|95.0|-0.7|1.3|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of better sleep in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.3|-.7|0.53
71699281|NCT05233761|142914161|SUPERIORITY|"The mean nightly difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.6||0.32|TWO_SIDED|95.0|-0.6|1.7|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep induction in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.7|-0.6|0.32
71699282|NCT05233761|142914161|SUPERIORITY|"The mean nightly difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.7|STANDARD_ERROR_OF_MEAN|0.6||0.2|TWO_SIDED|95.0|-0.4|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep duration in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.4|0.20
71699283|NCT05233761|142914161|SUPERIORITY|"The mean nightly difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.5|STANDARD_ERROR_OF_MEAN|0.6||0.45|TWO_SIDED|95.0|-0.7|1.6|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of sleep depth in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.6|-0.7|0.45
71699284|NCT05233761|142914161|SUPERIORITY|"The mean nightly difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control at the end of the two four-week treatment phases was analyzed using a two-sided test with an alpha level at 0.05 to evaluate superiority. The P-value and 95% confidence interval for the estimate of treatment differences was estimated and constructed using the above-mentioned method."|Mean Difference (Final Values)|0.6|STANDARD_ERROR_OF_MEAN|0.7||0.4|TWO_SIDED|95.0|-0.8|1.9|||t-test, 2 sided|||"The null hypothesis was that there was no difference in the perception of vivid dreams in participants that received CBD-terpenes and the placebo control; the alternative hypothesis was that there was a significant difference among the two treatment groups."||1.9|-0.8|0.4
71699285|NCT02100631|142914219|NON_INFERIORITY|The lower limit of the two sided 95% Wald CI on the difference in seroconversion rate was estimated by inverting a Z test with pooled variance. The lower limit of the CI had be greater than -10 percentage points to prove non-inferiority. The lower bound of the CI on the older adults serconversion rate was required to exceed 70%.|Risk Difference (RD)|-3.1|||||TWO_SIDED|95.0|-6.7|0.4||||||||0.4|-6.7|
71699286|NCT02100631|142914220|OTHER||Geometric Mean Ratio (GMR)|0.44|||||TWO_SIDED|95.0|0.34|0.57||||||||0.57|0.34|
71699287|NCT02100631|142914221|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.|Risk Difference (RD)|0.6|||||TWO_SIDED|95.0|-2.2|3.5||||||||3.5|-2.2|
71699288|NCT02100631|142914222|NON_INFERIORITY|Analysis for information only. No non-inferiority margin specified.||||||0.0062|||||||t-test, 2 sided|||||||0.0062
71699289|NCT00300053|142914225|SUPERIORITY|||||||0.02|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.020
71699290|NCT00300053|142914225|SUPERIORITY|||||||0.035|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.035
71699291|NCT00300053|142914225|SUPERIORITY|||||||0.167|||||||ANCOVA|||Frequency of angina episodes per week 6 months after treatment.||||0.167
71699292|NCT00300053|142914225|SUPERIORITY|||||||0.181|||||||ANCOVA|||Frequency of angina episodes per week 12 months after treatment.||||0.181
71699293|NCT00300053|142914226|SUPERIORITY|||||||0.014|||||||ANCOVA|||Change from baseline to 6 months||||0.014
71699294|NCT00300053|142914226|SUPERIORITY|||||||0.017|||||||ANCOVA|||Change from baseline to 12 months||||0.017
71699295|NCT00300053|142914226|SUPERIORITY|||||||0.097|||||||ANCOVA|||Change from baseline to 6 months||||0.097
71699296|NCT00300053|142914226|SUPERIORITY|||||||0.134|||||||ANCOVA|||Change from baseline to 12 months||||0.134
71699297|NCT00204737|142914318|OTHER|||||||0.06|||||||Fisher Exact|||comparison at 2 Weeks||||0.06
71699298|NCT00204737|142914318|OTHER|||||||0.18|||||||Fisher Exact|||Comparison at 6 Weeks||||0.18
71699299|NCT00204737|142914318|OTHER|||||||0.5|||||||Fisher Exact|||Comparison at 12 weeks||||0.5
71699300|NCT02054156|142914390|SUPERIORITY||Hazard Ratio (HR)|0.56||||0.0043|TWO_SIDED|95.0|0.37|0.83|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||0.83|0.37|0.0043
71699301|NCT02054156|142914391|SUPERIORITY||Hazard Ratio (HR)|1.0||||0.9915|TWO_SIDED|95.0|0.64|1.55|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (\>=6 months - 3 years, \>3 - 6 years, \>6 - 12 years, and \>12 - 18 years).|||1.55|0.64|0.9915
71699302|NCT02054156|142914392|SUPERIORITY||Difference in % of Participants with SAE|-2.5||||0.7531|TWO_SIDED|95.0|-13.7|8.7|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.|||8.7|-13.7|0.7531
71699303|NCT02054156|142914392|SUPERIORITY||Difference in % of Participants with AE|4.4||||0.3593|TWO_SIDED|95.0|-3.5|12.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson.|||12.6|-3.5|0.3593
71699304|NCT02054156|142914393|SUPERIORITY||Rate Ratio|0.86||||0.0004|TWO_SIDED|95.0|0.8|0.94|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||0.94|0.80|0.0004
71699305|NCT02054156|142914393|SUPERIORITY||Rate Ratio|1.25||||0.2098|TWO_SIDED|95.0|0.88|1.78|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.||1.78|0.88|0.2098
71699306|NCT01928849|142914399|OTHER||Odds Ratio (OR)|0.77||||0.53|TWO_SIDED|95.0|0.34|1.74|||Regression, Logistic|Univariable Logistic regression||||1.74|0.34|0.53
71699307|NCT01928849|142914400|OTHER|||||||0.95|||||||Chi-squared|||Comparison of rate of residual limb pain between treatment groups||||0.95
71699308|NCT01928849|142914400|OTHER|||||||0.74|||||||Chi-squared|||Comparison of rate of Phantom limb pain between treatment groups||||0.74
71699309|NCT01928849|142914401|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 0-24||||0.27
71699310|NCT01928849|142914401|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 24-48||||0.27
71699311|NCT01928849|142914402|OTHER|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI average pain score||||0.59
71699312|NCT01928849|142914402|OTHER|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI Interference question sum||||0.16
71699313|NCT01928849|142914403|OTHER|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||||||0.35
71699314|NCT01928849|142914404|OTHER|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS numeric pain score||||0.42
71699315|NCT01928849|142914404|OTHER|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS supplemental question sum||||0.19
71699316|NCT01928849|142914405|OTHER|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 0-24||||0.27
71699317|NCT01928849|142914405|OTHER|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 24-48||||0.26
71699318|NCT00297167|142914417|SUPERIORITY_OR_OTHER||Least Square (LS) Mean Difference|-25.52|||<|0.001|TWO_SIDED|95.0|-31.73|-19.32|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-19.32|-31.73|<0.001
71699319|NCT00297167|142914418|SUPERIORITY_OR_OTHER||LS Mean Difference|-21.5|||<|0.001|TWO_SIDED|95.0|-26.85|-16.14|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.||-16.14|-26.85|<0.001
71699320|NCT03185208|142914433|SUPERIORITY||treatment x time interaction coefficient|0.69||||0.048|TWO_SIDED||||||Mixed Models Analysis|||||||0.048
71699321|NCT03185208|142914434|SUPERIORITY||treatment x time interaction coefficient|-0.08835||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
71699322|NCT03185208|142914435|SUPERIORITY||treatment x time interaction coefficient|0.08738||||0.8|TWO_SIDED||||||Mixed Models Analysis|||||||0.80
71699323|NCT03185208|142914437|SUPERIORITY||treatment x time interaction coefficient|0.012||||0.93|TWO_SIDED||||||Mixed Models Analysis|||||||0.93
71699324|NCT03185208|142914438|SUPERIORITY||treatment x time interaction coefficient|-351.8||||0.78|TWO_SIDED||||||Mixed Models Analysis|||||||0.78
71699325|NCT03185208|142914439|SUPERIORITY||treatment x time interaction coefficient|58.95||||0.087|TWO_SIDED||||||Mixed Models Analysis|||||||0.087
71699326|NCT02701634|142914447|SUPERIORITY|||||||0.99||||||P-value was calculated using the stratified Cochran-Mantel-Haenszel Chi-square test.|Chi-squared|||||||0.99
71699327|NCT02701634|142914452|SUPERIORITY|||||||0.67|||||||Log Rank|||||||0.67
71699328|NCT02701634|142914453|SUPERIORITY|||||||0.33||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.33
71699329|NCT02701634|142914454|SUPERIORITY|||||||0.49||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided|||||||0.49
71699330|NCT02701634|142914455|SUPERIORITY||Hazard Ratio (HR)|1.09||||0.8|TWO_SIDED|95.0|0.55|2.18||P-value was calculated using the log-rank test and stratified for disease severity and usage of calcineurin inhibitor or mycophenolate mofetil (MMF).|Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for disease severity and usage of calcineurin inhibitor or MMF|||2.18|0.55|0.800
71699331|NCT01186770|142914459|SUPERIORITY||Least square (LS) mean difference|2.83||||0.1692||95.0|-1.21|6.86||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with treatment as effect and analysis region as covariate.||6.86|-1.21|0.1692
71699332|NCT01186770|142914459|SUPERIORITY||LS mean difference|6.51||||0.0016|TWO_SIDED|95.0|2.47|10.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||10.55|2.47|0.0016
71699333|NCT01186770|142914459|SUPERIORITY||LS mean difference|9.13|||<|0.0001|TWO_SIDED|95.0|5.09|13.18||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.||13.18|5.09|< 0.0001
71699334|NCT01186770|142914460|SUPERIORITY||Odds Ratio (OR)|1.23||||0.3076|TWO_SIDED|95.0|0.82|1.84||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||1.84|0.82|0.3076
71699335|NCT01186770|142914460|SUPERIORITY||Odds Ratio (OR)|1.54||||0.0339|TWO_SIDED|95.0|1.03|2.29||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.29|1.03|0.0339
71699336|NCT01186770|142914460|SUPERIORITY||Odds Ratio (OR)|1.79||||0.0043||95.0|1.2|2.66||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.||2.66|1.20|0.0043
71699337|NCT01186770|142914461|SUPERIORITY||LS mean difference|0.09||||0.692|TWO_SIDED|95.0|-0.36|0.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.55|-0.36|0.6920
71699338|NCT01186770|142914461|SUPERIORITY||LS mean difference|0.51||||0.0274|TWO_SIDED|95.0|0.06|0.97||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.97|0.06|0.0274
71699339|NCT01186770|142914461|SUPERIORITY||LS mean difference|0.53||||0.0237|TWO_SIDED|95.0|0.07|0.98||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.||0.98|0.07|0.0237
71699340|NCT01033136|142914462|EQUIVALENCE|To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.||||||0.3||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Fisher Exact|||||||0.30
71699341|NCT01033136|142914463|OTHER|||||||0.68||||||The threshold for statistical significance is p \<.05 and is not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom: 2, 54||Longitudinal analysis of PDSS scores||||0.68
71699342|NCT03609177|142914483|SUPERIORITY||Risk Difference (RD)|6.8|||<|0.05|TWO_SIDED|95.0|2.8|10.8|||binomial regression with identity link|||||10.8|2.8|<0.05
71699343|NCT03609177|142914484|SUPERIORITY||Risk Difference (RD)|-0.1|||<|0.05|TWO_SIDED|95.0|-0.7|0.6|||binomial regression with identity link|||||0.6|-0.7|<0.05
71699344|NCT03609177|142914485|SUPERIORITY||Risk Difference (RD)|0.7|||<|0.05|TWO_SIDED|95.0|-0.5|1.9|||binomial regression with identity link|||||1.90|-0.5|<0.05
71699345|NCT03609177|142914486|SUPERIORITY||Risk Difference (RD)|0.3|||<|0.05|TWO_SIDED|95.0|-0.4|1.0|||binomial regression with identity link|||||1.0|-0.4|<0.05
71699346|NCT02855268|142914491|SUPERIORITY||Least square mean difference|-0.22|STANDARD_ERROR_OF_MEAN|3.27||0.9472|TWO_SIDED|95.0|-6.92|6.48||Threshold of significance was 1-sided \<0.025.|Linear mixed effect model|||Annualized rate of change in eGFR during the placebo-controlled treatment period was compared between lademirsen and placebo using a random coefficient linear mixed effect model which included time as a continuous variable.||6.48|-6.92|0.9472
71699347|NCT00914069|142914518|SUPERIORITY_OR_OTHER|||||||0.05||||||Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.|Fisher Exact|||||||0.05
71699348|NCT00914069|142914521|SUPERIORITY_OR_OTHER|||||||0.8|||||||Fisher Exact|||||||0.8
71699349|NCT05722015|142914526|NON_INFERIORITY|Non-inferiority margin is 0.8.|Geometric Mean Ratio (GMR)|1.14|||<|1e-05|TWO_SIDED|96.0|1.06|1.22|||Welch's t test|One-sided p-value was calculated using the Welch's t test.|GMR was calculated as the ratio of geometric mean (GM) of Cycle 1 AUC0-6 weeks in Arm 1 to that of Arm 2. The associated 96% confidence interval (CI) were calculated using Welch's t test.|||1.22|1.06|<0.00001
71699350|NCT05722015|142914527|NON_INFERIORITY|Non-inferiority margin is 0.8.|GMR|1.67|||<|1e-05|TWO_SIDED|94.0|1.52|1.84|||Welch's t test|One sided p-value was calculated using Welch's t test.|GMR was calculated as the ratio of GM of Cycle 3 Ctrough in Arm 1 to that of Arm 2. The associated 94% CI were calculated using Welch's t test.|||1.84|1.52|<0.00001
71699351|NCT04513366|142914542|SUPERIORITY||Risk Difference (RD)|0.44|||<|0.0001|TWO_SIDED|97.5|0.23|0.64|||Mantel Haenszel|||||0.64|0.23|<.0001
71699352|NCT04513366|142914542|SUPERIORITY||Risk Difference (RD)|0.53|||<|0.0001|TWO_SIDED|97.5|0.32|0.73|||Mantel Haenszel|||||0.73|0.32|<.0001
71699353|NCT04513366|142914543|SUPERIORITY||Least Square (LS) Mean Difference|-5.3|||<|0.001|TWO_SIDED|97.5|-7.18|-3.42|||ANCOVA|||||-3.42|-7.18|<.001
71699354|NCT04513366|142914543|SUPERIORITY||LS Mean Difference|-5.6|||<|0.001|TWO_SIDED|97.5|-7.57|-3.7|||ANCOVA|||||-3.70|-7.57|<.001
71699355|NCT04513366|142914544|SUPERIORITY||LS Mean Difference|-64.3|||<|0.001|TWO_SIDED|97.5|-87.85|-40.85|||ANCOVA|||||-40.85|-87.85|<.001
71699356|NCT04513366|142914544|SUPERIORITY||LS Mean Difference|-69.8|||<|0.001|TWO_SIDED|97.5|-92.16|-47.35|||ANCOVA|||||-47.35|-92.16|<.001
71699357|NCT04513366|142914545|SUPERIORITY||LS Mean Difference|4.5|STANDARD_ERROR_OF_MEAN|2.6||0.09|TWO_SIDED||||||Mixed Models Analysis|||||||0.090
71699358|NCT04513366|142914545|SUPERIORITY||LS Mean Difference|1.8|STANDARD_ERROR_OF_MEAN|2.5||0.472|TWO_SIDED||||||Mixed Models Analysis|||||||0.472
71699359|NCT04513366|142914546|SUPERIORITY||Difference|0.58||||0.0003|TWO_SIDED|97.5|0.25|0.91|||Chi-squared|||||0.91|0.25|0.0003
71699360|NCT04513366|142914546|SUPERIORITY||Difference|0.25||||0.1895|TWO_SIDED|97.5|-0.36|0.86|||Chi-squared|||||0.86|-0.36|0.1895
71699361|NCT04513366|142914547|SUPERIORITY||Difference|0.43||||0.0035|TWO_SIDED|97.5|0.14|0.72|||Chi-squared|||||0.72|0.14|0.0035
71699362|NCT04513366|142914547|SUPERIORITY||Difference|0.28||||0.0428|TWO_SIDED|97.5|-0.02|0.57|||Chi-squared|||||0.57|-0.02|0.0428
71699363|NCT04513366|142914548|SUPERIORITY||LS Mean Difference|-0.2||||0.517|TWO_SIDED|97.5|-1.1|0.61|||Mixed Models Analysis|||||0.61|-1.10|0.517
71699364|NCT04513366|142914548|SUPERIORITY||LS Mean Difference|0.4||||0.23|TWO_SIDED|97.5|-0.39|1.28|||Mixed Models Analysis|||||1.28|-0.39|0.230
71699365|NCT04513366|142914549|SUPERIORITY||LS Mean Difference|-0.1||||0.25|TWO_SIDED|97.5|-0.35|0.12|||Mixed Models Analysis|||||0.12|-0.35|0.250
71699366|NCT04513366|142914549|SUPERIORITY||LS Mean Difference|0.1||||0.506|TWO_SIDED|97.5|-0.16|0.29|||Mixed Models Analysis|||||0.29|-0.16|0.506
71699367|NCT04513366|142914550|SUPERIORITY||LS Mean Difference|-0.1||||0.653|TWO_SIDED|97.5|-0.55|0.37|||ANOVA|||||0.37|-0.55|0.653
71699368|NCT04513366|142914550|SUPERIORITY||LS Mean Difference|0.1||||0.629|TWO_SIDED|97.5|-0.36|0.56|||ANOVA|||||0.56|-0.36|0.629
71699369|NCT04513366|142914551|SUPERIORITY||LS Mean Difference|0.1||||0.731|TWO_SIDED|97.5|-0.4|0.54|||ANOVA|||Treatment Periods 1-3 (Months 1-3)||0.54|-0.40|0.731
71699370|NCT04513366|142914551|SUPERIORITY||LS Mean Difference|0.1||||0.583|TWO_SIDED|97.5|-0.35|0.58|||ANOVA|||Treatment Periods 1-3 (Month 1-3)||0.58|-0.35|0.583
71699371|NCT04478266|142914559|SUPERIORITY||Hazard Ratio (HR)|1.209||||0.9304|TWO_SIDED|95.0|0.939|1.557||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025 level.|Stratified Log-Rank test|Stratified on presence of De-novo metastatic disease, Postmenopausal women and Visceral metastasis according to IRT.|Letrozole + Palbociclib versus Amcenestrant + Palbociclib|A hierarchical testing procedure was used to ensure a strong control of the overall Type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at one-sided 2.5% for the primary and the first secondary outcome.||1.557|0.939|0.9304
71699372|NCT04058717|142914576|OTHER||H-statistic|10.23||||0.017|TWO_SIDED||||||Kruskal-Wallis|||||||0.017
71699373|NCT04058717|142914577|OTHER||H-statistic|7.57||||0.056|TWO_SIDED||||||Kruskal-Wallis|||||||0.056
71699374|NCT04058717|142914578|OTHER||H-statistic|1.26||||0.74|TWO_SIDED||||||Kruskal-Wallis|||||||0.74
71699375|NCT04058717|142914579|OTHER||Slope|4.13||||0.248|TWO_SIDED||||||Kruskal-Wallis|||||||0.248
71699376|NCT04058717|142914580|OTHER||H-statistic|9.33||||0.025|TWO_SIDED||||||Kruskal-Wallis|||||||0.025
71699377|NCT04058717|142914581|OTHER|||||||0.289|||||||Fisher Exact|||||||0.289
71699378|NCT03074500|142914592|SUPERIORITY|||||||0.643|||||||Kruskal-Wallis|||Comparison of baseline values||||0.643
71699379|NCT03074500|142914592|SUPERIORITY|||||||0.018|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.018
71699380|NCT03074500|142914592|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Comparison of 4 week After Treatment Values||||0.027
71699381|NCT03074500|142914592|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
71699382|NCT03074500|142914592|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.677
71699383|NCT03074500|142914592|SUPERIORITY|||||||0.326||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of baseline values||||0.326
71699384|NCT03074500|142914592|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.019
71699385|NCT03074500|142914592|SUPERIORITY|||||||0.014||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.014
71699386|NCT03074500|142914592|SUPERIORITY|||||||0.427||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.427
71699387|NCT03074500|142914592|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
71699388|NCT03074500|142914592|SUPERIORITY|||||||0.021||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.021
71699389|NCT03074500|142914592|SUPERIORITY|||||||0.545||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Value||||0.545
71699390|NCT03074500|142914592|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
71699391|NCT03074500|142914592|SUPERIORITY|||||||0.67|||||||Friedman's two-way analysis of variance|||||||0.670
71699392|NCT03074500|142914592|SUPERIORITY|||||||0.192|||||||Friedman's two-way analysis of variance|||||||0.192
71699393|NCT03074500|142914593|SUPERIORITY|||||||0.633|||||||Kruskal-Wallis|||Comparison of Before Treatment Values||||0.633
71699394|NCT03074500|142914593|SUPERIORITY|||||||0.282|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.282
71699395|NCT03074500|142914593|SUPERIORITY|||||||0.015|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.015
71699396|NCT03074500|142914593|SUPERIORITY|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.677
71699397|NCT03074500|142914593|SUPERIORITY|||||||0.344||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.344
71699398|NCT03074500|142914593|SUPERIORITY|||||||0.596||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Before Treatment Values||||0.596
71699399|NCT03074500|142914593|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
71699400|NCT03074500|142914593|SUPERIORITY|||||||0.257||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.257
71699401|NCT03074500|142914593|SUPERIORITY|||||||0.449||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.449
71699402|NCT03074500|142914593|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
71699403|NCT03074500|142914593|SUPERIORITY|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.019
71699404|NCT03074500|142914593|SUPERIORITY|||||||0.325||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.325
71699405|NCT03074500|142914593|SUPERIORITY|||||||0.003|||||||Friedman's two-way analysis of variance|||||||0.003
71699406|NCT03074500|142914593|SUPERIORITY|||||||0.323|||||||Friedman's two-way analysis of variance|||||||0.323
71699407|NCT03074500|142914593|SUPERIORITY|||||||0.641|||||||Friedman's two-way analysis of variance|||||||0.641
71699408|NCT03074500|142914594|SUPERIORITY|||||||0.715|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.715
71699409|NCT03074500|142914594|SUPERIORITY|||||||0.227|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.227
71699410|NCT03074500|142914594|SUPERIORITY|||||||0.012|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.012
71699411|NCT03074500|142914594|SUPERIORITY|||||||0.907||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.907
71699412|NCT03074500|142914594|SUPERIORITY|||||||0.482||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.482
71699413|NCT03074500|142914594|SUPERIORITY|||||||0.485||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.485
71699414|NCT03074500|142914594|SUPERIORITY|||||||0.129||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.129
71699415|NCT03074500|142914594|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
71699416|NCT03074500|142914594|SUPERIORITY|||||||0.935||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.935
71699417|NCT03074500|142914594|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.002
71699418|NCT03074500|142914594|SUPERIORITY|||||||0.036||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.036
71699419|NCT03074500|142914594|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.056
71699420|NCT03074500|142914594|SUPERIORITY|||||||0.016|||||||Friedman's two-way analysis of variance|||||||0.016
71699421|NCT03074500|142914594|SUPERIORITY|||||||0.618|||||||Friedman's two-way analysis of variance|||||||0.618
71699422|NCT03074500|142914594|SUPERIORITY|||||||0.48|||||||Friedman's two-way analysis of variance|||||||0.48
71699423|NCT03074500|142914594|SUPERIORITY|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.034
71699424|NCT03074500|142914594|SUPERIORITY|||||||0.041|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.041
71699425|NCT03074500|142914594|SUPERIORITY|||||||1|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||1
71699426|NCT03074500|142914595|SUPERIORITY|||||||0.103|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.103
71699427|NCT03074500|142914595|SUPERIORITY|||||||0.002|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.002
71699428|NCT03074500|142914595|SUPERIORITY|||||||0.008|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.008
71699429|NCT03074500|142914595|SUPERIORITY|||||||0.76||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.76
71699430|NCT03074500|142914595|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
71699431|NCT03074500|142914595|SUPERIORITY|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.056
71699432|NCT03074500|142914595|SUPERIORITY|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.002
71699433|NCT03074500|142914595|SUPERIORITY|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.12
71699434|NCT03074500|142914595|SUPERIORITY|||||||0.117||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.117
71699435|NCT03074500|142914595|SUPERIORITY|||||||0.006||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.006
71699436|NCT03074500|142914595|SUPERIORITY|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.013
71699437|NCT03074500|142914595|SUPERIORITY|||||||0.487||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.487
71699438|NCT03074500|142914595|SUPERIORITY|||||||0.002|||||||Friedman's two-way analysis of variance|||||||0.002
71699439|NCT03074500|142914595|SUPERIORITY|||||||0.102|||||||Friedman's two-way analysis of variance|||||||0.102
71699440|NCT03074500|142914595|SUPERIORITY|||||||0.165|||||||Friedman's two-way analysis of variance|||||||0.165
71699441|NCT03074500|142914595|SUPERIORITY|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.007
71699442|NCT03074500|142914595|SUPERIORITY|||||||0.028|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.028
71699443|NCT03074500|142914595|SUPERIORITY|||||||0.83|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.83
71699444|NCT03074500|142914596|SUPERIORITY|||||||0.837|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.837
71699445|NCT03074500|142914596|SUPERIORITY|||||||0.215|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.215
71699446|NCT03074500|142914596|SUPERIORITY|||||||0.078|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.078
71699447|NCT03074500|142914596|SUPERIORITY|||||||0.699||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.699
71699448|NCT03074500|142914596|SUPERIORITY|||||||0.846||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.846
71699449|NCT03074500|142914596|SUPERIORITY|||||||0.56||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.56
71699450|NCT03074500|142914596|SUPERIORITY|||||||0.087||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.087
71699451|NCT03074500|142914596|SUPERIORITY|||||||0.183||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.183
71699452|NCT03074500|142914596|SUPERIORITY|||||||0.719||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.719
71699453|NCT03074500|142914596|SUPERIORITY|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.023
71699454|NCT03074500|142914596|SUPERIORITY|||||||0.196||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.196
71699455|NCT03074500|142914596|SUPERIORITY|||||||0.318||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.318
71699456|NCT03074500|142914596|SUPERIORITY|||||||0.001|||||||Friedman's two-way analysis of variance|||||||0.001
71699457|NCT03074500|142914596|SUPERIORITY|||||||0.483|||||||Friedman's two-way analysis of variance|||||||0.483
71699458|NCT03074500|142914596|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
71699459|NCT03074500|142914597|SUPERIORITY|||||||0.897|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.897
71699460|NCT03074500|142914597|SUPERIORITY|||||||0.325|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.325
71699461|NCT03074500|142914597|SUPERIORITY|||||||0.172|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.172
71699462|NCT03074500|142914597|SUPERIORITY|||||||0.622||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.622
71699463|NCT03074500|142914597|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.909
71699464|NCT03074500|142914597|SUPERIORITY|||||||0.79||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.79
71699465|NCT03074500|142914597|SUPERIORITY|||||||0.24||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.24
71699466|NCT03074500|142914597|SUPERIORITY|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.161
71699467|NCT03074500|142914597|SUPERIORITY|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.909
71699468|NCT03074500|142914597|SUPERIORITY|||||||0.255||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.255
71699469|NCT03074500|142914597|SUPERIORITY|||||||0.058||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.058
71699470|NCT03074500|142914597|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
71699471|NCT03074500|142914597|SUPERIORITY|||||||0.007|||||||Friedman's two-way analysis of variance|||||||0.007
71699472|NCT03074500|142914597|SUPERIORITY|||||||0.614|||||||Friedman's two-way analysis of variance|||||||0.614
71699473|NCT03074500|142914597|SUPERIORITY|||||||0.072|||||||Friedman's two-way analysis of variance|||||||0.072
71699474|NCT03074500|142914597|SUPERIORITY|||||||0.447|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.447
71699475|NCT03074500|142914597|SUPERIORITY|||||||0.084|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.084
71699476|NCT03074500|142914597|SUPERIORITY|||||||0.235|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.235
71699477|NCT03074500|142914598|SUPERIORITY|||||||0.958|||||||Kruskal-Wallis|||Comparison of Baseline Values||||0.958
71699478|NCT03074500|142914598|SUPERIORITY|||||||0.597|||||||Kruskal-Wallis|||Comparison of After Treatment Values||||0.597
71699479|NCT03074500|142914598|SUPERIORITY|||||||0.518|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values||||0.518
71699480|NCT03074500|142914598|SUPERIORITY|||||||0.88||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.88
71699481|NCT03074500|142914598|SUPERIORITY|||||||0.733||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||0.733
71699482|NCT03074500|142914598|SUPERIORITY|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of Baseline Values||||1
71699483|NCT03074500|142914598|SUPERIORITY|||||||0.404||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.404
71699484|NCT03074500|142914598|SUPERIORITY|||||||0.97||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.97
71699485|NCT03074500|142914598|SUPERIORITY|||||||0.362||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of After Treatment Values||||0.362
71699486|NCT03074500|142914598|SUPERIORITY|||||||0.271||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.271
71699487|NCT03074500|142914598|SUPERIORITY|||||||0.519||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.519
71699488|NCT03074500|142914598|SUPERIORITY|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p\<0.017 is significant||Comparison of 4 week After Treatment Values||||0.569
71699489|NCT03074500|142914598|SUPERIORITY|||||||0.004|||||||Friedman's two-way analysis of variance|||||||0.004
71699490|NCT03074500|142914598|SUPERIORITY|||||||0.973|||||||Friedman's two-way analysis of variance|||||||0.973
71699491|NCT03074500|142914598|SUPERIORITY|||||||0.886|||||||Friedman's two-way analysis of variance|||||||0.886
71699492|NCT03074500|142914598|SUPERIORITY|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups||||0.82
71699493|NCT03074500|142914598|SUPERIORITY|||||||0.017|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.017
71699494|NCT03074500|142914598|SUPERIORITY|||||||0.734|||||||Kruskal-Wallis|||Immediate effect compared to baseline||||0.734
71758612|NCT00836693|143019588|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|0.37||0.0461|TWO_SIDED|95.0|0.0|1.5||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.5|0.0|0.0461
71699495|NCT03857256|142914602|SUPERIORITY|Mean changes from Week 0 in LDL-C were analyzed using a restricted maximum likelihood (REML)-based repeated measures approach including effects of treatment group, time (Week 6 and Week 12) and treatment group x time interaction as well as the covariates of Week 0 value of LDL-C and Week 0 value of LDL-C x time interaction. An unstructured covariance structure were used to model the within-patient errors. Contrasts under this model allowed for the three main comparisons.||||||0.0167||||||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).|Mixed Models Analysis|The Kenward-Roger approximation were used to estimate denominator degrees of freedom.||Tests involving the comparisons of each of the active groups versus placebo for the primary endpoint were conducted at the 0.0167 significance level (to account for three main comparisons).||||0.0167
71699496|NCT03114150|142914613|SUPERIORITY||Slope|-0.02|||<|0.05|TWO_SIDED|95.0|-0.04|0.01|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of group, learning rate, and session.|We tested the prediction that learning rate would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.01|-.04|<.05
71699497|NCT03114150|142914614|SUPERIORITY||Mean Difference (Final Values)|0.01|||<|0.05|TWO_SIDED|95.0|-0.01|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom|Parameter is the interaction term for the interaction of exercise condition (intensity) and session.|We tested the prediction that hippocampal-cortical functional connectivity would change more for the moderate-to-vigorous acute condition compared to the light intensity condition. This prediction was tested with a linear mixed model, according to our statistical analysis plan.||.02|-.01|<.05
71699498|NCT03114150|142914615|SUPERIORITY||Mean Difference (Net)|0.0|||<|0.05|TWO_SIDED|95.0|-0.03|0.02|||Mixed Models Analysis|Kenward-Roger adjustments for degrees of freedom||We tested the prediction that functional connectivity strength would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, according to our statistical analysis plan.|Parameter is the interaction term for the interaction of group and session.|.02|-.03|<.05
71699499|NCT03114150|142914616|SUPERIORITY||Mean Difference (Final Values)|1.42|||<|0.05|TWO_SIDED|95.0|0.27|2.59|||Mixed Models Analysis|Residualized change model, as reported in our protocol paper.||We tested the prediction that cardiorespiratory fitness would increase more so for the moderate-to-vigorous training group compared to the light intensity training group. This prediction was tested with a linear mixed model, as reported in our protocol paper.||2.59|.27|<.05
71699500|NCT00320086|142914617|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.05|||||||ANOVA|||ANOVA||||<0.05
71699501|NCT03979313|142914625|SUPERIORITY||Relative Risk Reduction (RRR)|62.15||||0.0708|TWO_SIDED|95.0|-8.57|86.8|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||86.80|-8.57|0.0708
71699502|NCT03979313|142914626|SUPERIORITY||Relative Risk Reduction (RRR)|74.53|||<|0.0001|TWO_SIDED|95.0|49.63|87.12|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||87.12|49.63|<0.0001
71699503|NCT03979313|142914627|SUPERIORITY||Relative Risk Reduction (RRR)|76.36|||<|0.0001|TWO_SIDED|95.0|62.27|85.18|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||85.18|62.27|<0.0001
71699504|NCT03979313|142914628|SUPERIORITY||Relative Risk Reduction (RRR)|76.84||||0.0002|TWO_SIDED|95.0|49.36|89.41|||Poisson Model||RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors \[age at randomisation\] as covariate) obtained after multiple imputation|||89.41|49.36|0.0002
71699505|NCT00089648|142914632|SUPERIORITY_OR_OTHER||Objective Response Rate (ORR) (percent)|23.0||||||95.0|13.2|35.5|||||ORR=proportion of subjects with confirmed CR or PR, relative to total number of subjects who received at least 1 dose of study medication, were refractory to bevacizumab, had a baseline disease assessment and had the correct histological cancer type.|||35.5|13.2|
71699506|NCT03183908|142914648|NON_INFERIORITY|The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 5%, stratified by site.|Difference in proportions|-2.7|||||TWO_SIDED|95.0|-5.8|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|The null hypothesis is allV3 is inferior (i.e., allV3 will have higher rates of moderate/severe injection site pain) to IIV3-HD in regards to the proportion of subjects having moderate or severe injection site pain in the first week post vaccination.||0.4|-5.8|
71699507|NCT03183908|142914650|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|2.38|||||TWO_SIDED|95.0|1.09|4.47||||||||4.47|1.09|
71699508|NCT03183908|142914650|OTHER|The comparison of the number of participants with reported SAEs regardless of relationship to study product were made using 95% confidence intervals. Results were reported using exact binomial confidence intervals.|Comparison of Frequencies|0.79|||||TWO_SIDED|95.0|0.16|2.23||||||||2.23|0.16|
71699509|NCT03183908|142914651|NON_INFERIORITY|This objective will be assessed using a one-sided noninferiority test with the alpha level set at 0.025 and noninferiority margin of 10%. The null hypothesis is the allV3 H3N2 seroconversion rate is inferior to IIV3-HD seroconversion rate.|Difference in Proportions|-0.0579||||0.1245|ONE_SIDED|97.5|-0.1291||||Cochran-Mantel-Haenszel||The directional comparison was the lower bound of the confidence interval using a 10% non-inferiority margin.||||-.1291|0.1245
71699510|NCT03183908|142914652|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.9|||||TWO_SIDED|98.0|-5.0|1.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||1.0|-5.0|
71699511|NCT03183908|142914652|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.3|-3.1|
71699512|NCT03183908|142914652|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-3.7|||||TWO_SIDED|98.0|-7.5|-0.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-0.3|-7.5|
71699513|NCT03183908|142914652|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.6|||||TWO_SIDED|98.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
71699514|NCT03183908|142914653|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-5.2|0.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||0.2|-5.2|
71699515|NCT03183908|142914653|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.3|||||TWO_SIDED|95.0|-2.3|4.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||4.9|-2.3|
71699516|NCT03183908|142914653|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-4.5|||||TWO_SIDED|95.0|-8.1|-1.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||-1.1|-8.1|
71699517|NCT03183908|142914653|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.6|||||TWO_SIDED|95.0|-2.7|5.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||5.9|-2.7|
71699518|NCT03183908|142914653|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-3.1|||||TWO_SIDED|95.0|-6.9|0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||0.4|-6.9|
71699519|NCT03183908|142914654|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Redness||7.3|-7.3|
71699520|NCT03183908|142914654|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.3|||||TWO_SIDED|95.0|-9.5|5.7|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Shoulder Pain||5.7|-9.5|
71699521|NCT03183908|142914654|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-8.6|6.1|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Swelling||6.1|-8.6|
71699522|NCT03183908|142914654|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.4|||||TWO_SIDED|95.0|-5.7|8.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Tenderness||8.3|-5.7|
71699523|NCT03183908|142914654|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.2|||||TWO_SIDED|95.0|-7.9|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Injection Site Pain||5.4|-7.9|
71699524|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.4|-1.7|
71699525|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.5|||||TWO_SIDED|98.0|-2.8|2.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.3|-2.8|
71699526|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-1.1|||||TWO_SIDED|98.0|-4.0|1.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.5|-4.0|
71699527|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|3.2|||||TWO_SIDED|98.0|-0.8|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.3|-0.8|
71699528|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-2.5|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||2.0|-2.5|
71699529|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.3|||||TWO_SIDED|98.0|-3.0|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.0|
71699530|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|1.8|||||TWO_SIDED|98.0|-1.7|5.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||5.4|-1.7|
71699531|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.5|||||TWO_SIDED|98.0|-3.3|4.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.4|-3.3|
71699532|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|-0.8|||||TWO_SIDED|98.0|-3.1|1.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.6|-3.1|
71699533|NCT03183908|142914655|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.01 level to adjust for multiple comparisons.|Difference in proportions|0.0|||||TWO_SIDED|98.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
71699534|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.3|||||TWO_SIDED|95.0|-1.1|5.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||5.8|-1.1|
71699535|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.0|2.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Chills/Shivering||2.0|-3.0|
71699536|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.7|||||TWO_SIDED|95.0|-3.5|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||1.8|-3.5|
71699537|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|2.9|||||TWO_SIDED|95.0|-1.1|7.0|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||7.0|-1.1|
71699538|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.0|-0.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||-0.4|-3.0|
71699539|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-0.4|||||TWO_SIDED|95.0|-3.2|2.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Headache||2.4|-3.2|
71699540|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.9|||||TWO_SIDED|95.0|-2.5|4.5|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||4.5|-2.5|
71699541|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.6|||||TWO_SIDED|95.0|-3.1|4.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||4.3|-3.1|
71699542|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-1.0|||||TWO_SIDED|95.0|-3.3|1.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Nausea||1.3|-3.3|
71699543|NCT03183908|142914656|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.0|||||TWO_SIDED|95.0|-1.8|1.8|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Vomiting||1.8|-1.8|
71699544|NCT03183908|142914657|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.05|||||TWO_SIDED|95.0|-7.2|6.4|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Arthralgia||6.4|-7.2|
71699545|NCT03183908|142914657|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|-2.4|||||TWO_SIDED|95.0|-8.1|-0.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Diarrhea||-0.6|-8.1|
71699546|NCT03183908|142914657|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|3.7|||||TWO_SIDED|95.0|-3.6|10.9|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fatigue||10.9|-3.6|
71699547|NCT03183908|142914657|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|1.2|||||TWO_SIDED|95.0|-2.4|6.6|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Fever||6.6|-2.4|
71699548|NCT03183908|142914657|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|5.0|||||TWO_SIDED|95.0|2.0|12.2|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Malaise||12.2|2.0|
71699549|NCT03183908|142914657|NON_INFERIORITY|Site-stratified, 5% noninferiority test with a one-sided alpha at the 0.025 level.|Difference in proportions|0.1|||||TWO_SIDED|95.0|-7.3|7.3|||||The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.|Myalgia||7.3|-7.3|
71699550|NCT03183908|142914658|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5862|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.5862
71699551|NCT03183908|142914658|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5648|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5648
71699552|NCT03183908|142914658|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.4196|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes from Day 1 to Day 3 Group Comparisons||||0.4196
71699553|NCT03183908|142914658|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.2418|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2418
71699554|NCT03183908|142914658|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.0746|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.0746
71699555|NCT03183908|142914658|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.5497|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.5497
71699556|NCT03183908|142914659|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6278|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes for Day 1 to Day 3 Group Comparisons||||0.6278
71699557|NCT03183908|142914659|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5622|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.5622
71699558|NCT03183908|142914659|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.5538|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.5538
71699559|NCT03183908|142914659|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.231|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes from Day 1 to Day 3 Group Comparisons||||0.2310
71699560|NCT03183908|142914659|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.0435|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes from Day 1 to Day 3 Group Comparisons||||0.0435
71699561|NCT03183908|142914659|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.6519|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes from Day 1 to Day 3 Group Comparisons||||0.6519
71699562|NCT03183908|142914660|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Activity Limitation Changes from Day 1 to Day 3 Group Comparisons||||0.7483
71699563|NCT03183908|142914660|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7483|||||||Wilcoxon (Mann-Whitney)|||Daily Activities Changes for Day 1 to Day 3 Group Comparisons||||0.7483
71699564|NCT03183908|142914660|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4953|||||||Wilcoxon (Mann-Whitney)|||Basic Mobility Changes for Day 1 to Day 3 Group Comparisons||||0.4953
71699565|NCT03183908|142914660|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8669|||||||Wilcoxon (Mann-Whitney)|||Participation Restriction Changes for Day 1 to Day 3 Group Comparisons||||0.8669
71699566|NCT03183908|142914660|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.8451|||||||Wilcoxon (Mann-Whitney)|||Social Roles Changes for Day 1 to Day 3 Group Comparisons||||0.8451
71699567|NCT03183908|142914660|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7376|||||||Wilcoxon (Mann-Whitney)|||Instrumental Roles Changes for Day 1 to Day 3 Group Comparisons||||0.7376
71699568|NCT03183908|142914661|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7407|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.7407
71699569|NCT03183908|142914662|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4032|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes for Day 1 to Day 3 Group Comparisons||||0.4032
71699570|NCT03183908|142914663|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.4079|||||||Wilcoxon (Mann-Whitney)|||US Index Score Changes from Day 1 to Day 3 Group Comparisons||||0.4079
71699571|NCT03183908|142914664|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.01 with no adjustments set for multiple comparisons.||||||0.7948|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes for Day 1 to Day 3 Group Comparisons||||0.7948
71699572|NCT03183908|142914665|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. Alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.7953|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.7953
71699573|NCT03183908|142914666|SUPERIORITY|Non-parametric testing was used to evaluate the changes from baseline to compare between groups. A two-sided alpha level set at 0.05 with no adjustments set for multiple comparisons.||||||0.9329|||||||Wilcoxon (Mann-Whitney)|||EQ VAS Changes from Day 1 to Day 3 Group Comparisons||||0.9329
71699574|NCT02690727|142914714|SUPERIORITY_OR_OTHER||Ratio (%)|128.49||||0.0002|TWO_SIDED|90.0|119.13|138.59|||ANOVA|||||138.59|119.13|0.0002
71699575|NCT02690727|142914716|SUPERIORITY_OR_OTHER||Ratio (%)|139.27||||0.0278|TWO_SIDED|90.0|111.01|174.73|||ANOVA|||||174.73|111.01|0.0278
71699576|NCT04383132|142914759|OTHER|||||||0.388||||||Independent t-test was used to compare mean CIT between two groups. The statistical significance level was accepted as p\<0.05|t-test, 2 sided|||In sample size calculation, CIT and SD were used. It was found that 326 patients (163 per group) were required to detect a 60-second difference in CIT (SD 192 secs), with 80% power and two-sided alpha 0.05. The frequency of the auxiliary maneuvers was calculated that 324 patients were required for a 20% reduction in the auxiliary maneuvers. In case of becoming lost to follow up and withdrawal, the number of patients was expanded by 5%, and a total of 346 patients, were included in the study.||||0.388
71699577|NCT04383132|142914760|OTHER|||||||0.069||||||For the comparison of ancillary maneuvers Pearson chi-square test, Fisher's exact test, and Fisher-Freeman-Halton exact test were used.|Chi-squared|||||||0.069
71699578|NCT04383132|142914761|OTHER|||||||0.487||||||Independent t-test was used to compare mean CIL between two groups.|t-test, 2 sided|||||||0.487
71699579|NCT04383132|142914762|OTHER|||||||0.822|||||||Chi-squared|||||||0.822
71699580|NCT04383132|142914763|OTHER|||||||0.016|||||||Chi-squared|||||||0.016
71699581|NCT04383132|142914764|OTHER|||||||0.001|||||||t-test, 2 sided|||||||0.001
71699582|NCT04383132|142914765|OTHER|||||||0.184|||||||Fisher Exact|||||||0.184
71699583|NCT01129128|142914796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-173.0||||0.87|TWO_SIDED|95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.87
71699584|NCT01129128|142914796|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|705.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml||||0.82
71699585|NCT01129128|142914797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15793.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.82
71699586|NCT01129128|142914797|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23472.0||||0.68||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values||||||0.68
71699587|NCT01129128|142914798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-16.0||||0.9||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.90
71699588|NCT01129128|142914798|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.0||||0.76||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values||||||0.76
71699589|NCT01129128|142914799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.5||||0.98||95.0|||||Regression, Linear|controlled for baseline levels||||||0.98
71699590|NCT01129128|142914799|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|39.0||||0.34||95.0|||||Regression, Linear|controlled for baseline levels||||||0.34
71699591|NCT04497883|142914801|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|110.41|||||TWO_SIDED|90.0|91.7|132.94|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||132.94|91.70|
71699592|NCT04497883|142914802|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|122.49|||||TWO_SIDED|90.0|96.83|154.95|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||154.95|96.83|
71699593|NCT04497883|142914803|EQUIVALENCE|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric least square means|125.08|||||TWO_SIDED|90.0|97.99|159.64|||ANOVA|||The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.||159.64|97.99|
71699594|NCT02763566|142914846|SUPERIORITY||Hazard Ratio (HR)|0.499||||0.0001|TWO_SIDED|95.0|0.346|0.719|||Log Rank|||||0.719|0.346|0.0001
71699595|NCT02763566|142914847|SUPERIORITY||Hazard Ratio (HR)|0.376|||<|0.0001|TWO_SIDED|95.0|0.24|0.588|||Log Rank|||||0.588|0.240|<0.0001
71699596|NCT02763566|142914849|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71699597|NCT02763566|142914849|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71699598|NCT02763566|142914851|SUPERIORITY|||||||0.0456|||||||Cochran-Mantel-Haenszel|||||||0.0456
71699599|NCT02763566|142914851|SUPERIORITY|||||||0.0004|||||||Cochran-Mantel-Haenszel|||||||0.0004
71699600|NCT02763566|142914852|SUPERIORITY|||||||0.0003|||||||Cochran-Mantel-Haenszel|||||||0.0003
71699601|NCT02763566|142914852|SUPERIORITY||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||||||<0.0001
71699602|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-1.89|STANDARD_ERROR_OF_MEAN|1.77||0.287|TWO_SIDED|95.0|-5.36|1.59|||Mixed Models Analysis|||Global Health Status||1.59|-5.36|0.287
71699603|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-0.77|STANDARD_ERROR_OF_MEAN|1.46||0.597|TWO_SIDED|95.0|-3.64|2.1|||Mixed Models Analysis|||Functional Scales - Physical functioning||2.10|-3.64|0.597
71699604|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-0.31|STANDARD_ERROR_OF_MEAN|2.15||0.885|TWO_SIDED|95.0|-4.55|3.93|||Mixed Models Analysis|||Functional Scales - Role Functioning||3.93|-4.55|0.885
71699605|NCT02763566|142914853|SUPERIORITY||LSMean Difference|1.67|STANDARD_ERROR_OF_MEAN|1.74||0.34|TWO_SIDED|95.0|-1.77|5.1|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||5.10|-1.77|0.340
71699606|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-2.17|STANDARD_ERROR_OF_MEAN|1.62||0.182|TWO_SIDED|95.0|-5.37|1.03|||Mixed Models Analysis|||Functional Scales - Cognitive Functioning||1.03|-5.37|0.182
71699607|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-0.88|STANDARD_ERROR_OF_MEAN|2.12||0.678|TWO_SIDED|95.0|-5.05|3.29|||Mixed Models Analysis|||||3.29|-5.05|0.678
71699608|NCT02763566|142914853|SUPERIORITY||LSMean Difference|1.57|STANDARD_ERROR_OF_MEAN|1.7||0.355|TWO_SIDED|95.0|-1.77|4.91|||Mixed Models Analysis|||Symptom Scales - Fatigue||4.91|-1.77|0.355
71699609|NCT02763566|142914853|SUPERIORITY||LSMean Difference|0.95|STANDARD_ERROR_OF_MEAN|1.06||0.372|TWO_SIDED|95.0|-1.14|3.03|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||3.03|-1.14|0.372
71699610|NCT02763566|142914853|SUPERIORITY||LSMean Difference|0.74|STANDARD_ERROR_OF_MEAN|1.63||0.74|TWO_SIDED|95.0|-3.75|2.66|||Mixed Models Analysis|||Symptom Scales - Pain||2.66|-3.75|0.740
71699611|NCT02763566|142914853|SUPERIORITY||LSMean Difference|2.16|STANDARD_ERROR_OF_MEAN|1.84||0.24|TWO_SIDED|95.0|-1.46|5.78|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||5.78|-1.46|0.240
71699612|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-0.81|STANDARD_ERROR_OF_MEAN|1.92||0.673|TWO_SIDED|95.0|-4.6|2.97|||Mixed Models Analysis|||Symptom scales - Insomnia||2.97|-4.60|0.673
71699613|NCT02763566|142914853|SUPERIORITY||LSMean Difference|5.65|STANDARD_ERROR_OF_MEAN|1.74||0.001|TWO_SIDED|95.0|2.23|9.07|||Mixed Models Analysis|||Symptom Scales - Appetite||9.07|2.23|0.001
71699614|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-1.57|STANDARD_ERROR_OF_MEAN|1.76||0.375|TWO_SIDED|95.0|-5.04|1.91|||Mixed Models Analysis|||Symptom Scales - Constipation||1.91|-5.04|0.375
71699615|NCT02763566|142914853|SUPERIORITY||LSMean Difference|15.82|STANDARD_ERROR_OF_MEAN|1.53||0|TWO_SIDED|95.0|12.81|18.84|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||18.84|12.81|0.000
71699616|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-1.75|STANDARD_ERROR_OF_MEAN|2.97||0.557|TWO_SIDED|95.0|-7.59|4.1|||Mixed Models Analysis|||Symptom Scales - Financial Difficulties||4.10|-7.59|0.557
71699617|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-3.47|STANDARD_ERROR_OF_MEAN|2.51||0.169|TWO_SIDED|95.0|-8.43|1.49|||Mixed Models Analysis|||Global Health Status||1.49|-8.43|0.169
71699618|NCT02763566|142914853|SUPERIORITY||LSMean Difference|1.58|STANDARD_ERROR_OF_MEAN|1.87||0.4|TWO_SIDED|95.0|-2.12|5.29|||Mixed Models Analysis|||Functional Scales - Physical Functioning||5.29|-2.12|0.400
71699619|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-1.72|STANDARD_ERROR_OF_MEAN|2.38||0.472|TWO_SIDED|95.0|-6.42|2.99|||Mixed Models Analysis|||Functional Scales - Role functioning||2.99|-6.42|0.472
71699620|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|0.31||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Emotional Functioning||2.28|-7.12|0.310
71699621|NCT02763566|142914853|SUPERIORITY||LSMean Difference|0.64|STANDARD_ERROR_OF_MEAN|2.98||0.83|TWO_SIDED|95.0|-5.26|6.55|||Mixed Models Analysis|||Functional Scales - Social Functioning||6.55|-5.26|0.830
71699622|NCT02763566|142914853|SUPERIORITY||LSMean Difference|2.73|STANDARD_ERROR_OF_MEAN|2.52||0.281|TWO_SIDED|95.0|-2.26|7.72|||Mixed Models Analysis|||Symptom Scales - Fatigue||7.72|-2.26|0.281
71699623|NCT02763566|142914853|SUPERIORITY||LSMean Difference|2.59|STANDARD_ERROR_OF_MEAN|1.99||0.194|TWO_SIDED|95.0|-1.33|6.52|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting||6.52|-1.33|0.194
71699624|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-2.66|STANDARD_ERROR_OF_MEAN|2.42||0.275|TWO_SIDED|95.0|-7.45|2.14|||Mixed Models Analysis|||Symptom Scales - Pain||2.14|-7.45|0.275
71699625|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-2.49|STANDARD_ERROR_OF_MEAN|4.39||0.28|TWO_SIDED|95.0|-7.04|2.06|||Mixed Models Analysis|||Symptom Scales - Dyspnoea||2.06|-7.04|0.280
71699626|NCT02763566|142914853|SUPERIORITY||LSMean Difference|1.97|STANDARD_ERROR_OF_MEAN|2.9||0.499|TWO_SIDED|95.0|-3.78|7.72|||Mixed Models Analysis|||Symptom Scales - Insomnia||7.72|-3.78|0.499
71699627|NCT02763566|142914853|SUPERIORITY||LSMean Difference|7.46|STANDARD_ERROR_OF_MEAN|2.92||0.012|TWO_SIDED|95.0|1.68|13.23|||Mixed Models Analysis|||Symptom Scales - Appetite||13.23|1.68|0.012
71699628|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-2.28|STANDARD_ERROR_OF_MEAN|2.29||0.321|TWO_SIDED|95.0|-6.83|2.27|||Mixed Models Analysis|||Symptom Scales - Constipation||2.27|-6.83|0.321
71699629|NCT02763566|142914853|SUPERIORITY||LSMean Difference|17.83|STANDARD_ERROR_OF_MEAN|2.32||0|TWO_SIDED|95.0|13.25|22.41|||Mixed Models Analysis|||Symptom Scales - Diarrhoea||22.41|13.25|0.000
71699630|NCT02763566|142914853|SUPERIORITY||LSMean Difference|2.99|STANDARD_ERROR_OF_MEAN|3.14||0.342|TWO_SIDED|95.0|-3.21|9.19|||Mixed Models Analysis|||Symptom Scales - Financial DIfficulties||9.19|-3.21|0.342
71699631|NCT02763566|142914853|SUPERIORITY||LSMean Difference|-2.42|STANDARD_ERROR_OF_MEAN|2.38||0.31|TWO_SIDED|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Cognitive functioning||2.28|-7.12|0.310
71699632|NCT01933594|142914861|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||||||0.88
71699633|NCT01933594|142914862|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.94
71699634|NCT01933594|142914862|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.74
71699635|NCT01933594|142914862|SUPERIORITY|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.18
71699636|NCT01933594|142914862|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.16
71699637|NCT01933594|142914863|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||||||0.37
71699638|NCT01933594|142914864|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.9
71699639|NCT01933594|142914864|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.07
71699640|NCT01933594|142914864|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
71699641|NCT01933594|142914864|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.92
71699642|NCT01933594|142914865|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 6 hours post infusion||||0.44
71699643|NCT01933594|142914865|SUPERIORITY|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 12 hours post infusion||||0.024
71699644|NCT01933594|142914865|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.37
71699645|NCT01933594|142914865|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.79
71699646|NCT01933594|142914865|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.34
71699647|NCT01933594|142914866|SUPERIORITY|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||||||0.029
71699648|NCT01933594|142914867|SUPERIORITY|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||||||0.96
71699649|NCT01933594|142914868|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||||||0.54
71699650|NCT01933594|142914870|SUPERIORITY|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.19
71699651|NCT01933594|142914870|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.63
71699652|NCT01933594|142914870|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.94
71699653|NCT01933594|142914870|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.66
71699654|NCT01933594|142914870|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
71699655|NCT01933594|142914871|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion||||0.73
71699656|NCT01933594|142914871|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion||||0.9
71699657|NCT01933594|142914872|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.8
71699658|NCT01933594|142914872|SUPERIORITY|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.73
71699659|NCT01933594|142914872|SUPERIORITY|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.84
71699660|NCT01933594|142914872|SUPERIORITY|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.88
71699661|NCT01933594|142914872|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.64
71699662|NCT01933594|142914880|SUPERIORITY|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.34
71699663|NCT01933594|142914880|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
71699664|NCT01933594|142914880|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
71699665|NCT01933594|142914880|SUPERIORITY|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.008
71699666|NCT01933594|142914880|SUPERIORITY|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 2 weeks post infusion 4||||0.55
71699667|NCT01933594|142914880|SUPERIORITY|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 5 weeks post infusion 4||||0.48
71699668|NCT01933594|142914880|SUPERIORITY|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.54
71699669|NCT01933594|142914880|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 18 weeks post infusion 4||||0.47
71699670|NCT01933594|142914882|SUPERIORITY|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.95
71699671|NCT01933594|142914882|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.07
71699672|NCT01933594|142914882|SUPERIORITY|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.26
71699673|NCT01933594|142914883|SUPERIORITY|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.89
71699674|NCT01933594|142914883|SUPERIORITY|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.14
71699675|NCT01933594|142914883|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.74
71699676|NCT01933594|142914884|SUPERIORITY|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.71
71699677|NCT01933594|142914884|SUPERIORITY|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.79
71699678|NCT01933594|142914884|SUPERIORITY|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.38
71699679|NCT01933594|142914885|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||1
71699680|NCT01933594|142914885|SUPERIORITY|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.92
71699681|NCT01933594|142914885|SUPERIORITY|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.66
71699682|NCT01933594|142914886|SUPERIORITY|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||1
71699683|NCT01933594|142914886|SUPERIORITY|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.9
71699684|NCT01933594|142914886|SUPERIORITY|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.47
71699685|NCT01933594|142914887|SUPERIORITY|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.63
71699686|NCT01933594|142914887|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||hange from baseline to 24 hours post infusion 4||||0.51
71699687|NCT01933594|142914887|SUPERIORITY|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.028
71699688|NCT01933594|142914888|SUPERIORITY|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.62
71699689|NCT01933594|142914888|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
71699690|NCT01933594|142914888|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.69
71699691|NCT01933594|142914889|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.28
71699692|NCT01933594|142914889|SUPERIORITY|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.15
71699693|NCT01933594|142914889|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.81
71699694|NCT01933594|142914890|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
71699695|NCT01933594|142914890|SUPERIORITY|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.22
71699696|NCT01933594|142914890|SUPERIORITY|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.031
71699697|NCT01933594|142914891|SUPERIORITY|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion||||0.13
71699698|NCT01933594|142914891|SUPERIORITY|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion||||0.39
71699699|NCT01933594|142914891|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion||||0.12
71699700|NCT01933594|142914892|SUPERIORITY|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.7
71699701|NCT01933594|142914892|SUPERIORITY|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.51
71699702|NCT01933594|142914892|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
71699703|NCT01933594|142914893|SUPERIORITY|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.78
71699704|NCT01933594|142914893|SUPERIORITY|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.41
71699705|NCT01933594|142914893|SUPERIORITY|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4||||0.94
71699706|NCT01933594|142914894|SUPERIORITY|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD4||||0.69
71699707|NCT01933594|142914894|SUPERIORITY|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD4||||0.27
71699708|NCT01933594|142914895|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD8||||0.81
71699709|NCT01933594|142914895|SUPERIORITY|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD8||||0.81
71699710|NCT01933594|142914896|SUPERIORITY|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.37
71699711|NCT01933594|142914896|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.1
71699712|NCT01933594|142914896|SUPERIORITY|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.28
71699713|NCT01933594|142914896|SUPERIORITY|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.16
71699714|NCT01933594|142914896|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.12
71699715|NCT01933594|142914897|SUPERIORITY|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1||||0.027
71699716|NCT01933594|142914897|SUPERIORITY|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2||||0.004
71699717|NCT01933594|142914897|SUPERIORITY|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2||||0.1
71699718|NCT01933594|142914897|SUPERIORITY|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3||||0.022
71699719|NCT01933594|142914897|SUPERIORITY|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4||||0.17
71699720|NCT00315445|142914906|SUPERIORITY_OR_OTHER|||||||0.035||||||P values are from a repeated measures model|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0350
71699721|NCT00315445|142914906|SUPERIORITY_OR_OTHER|||||||0.0624||||||Repeated measures analysis to assess the effects due to treatment, center, and treatment by center. Missing values = last observation carried forward (LOCF). Covariates: gender, age, race, weight, baseline pain, and previous opioid use.|Mixed Models Analysis|||||||0.0624
71699722|NCT00315445|142914907|SUPERIORITY_OR_OTHER||Day 84 Mean|46.4|||||TWO_SIDED|90.0|40.2|48.7|||Day 84 Mean|||||48.7|40.2|
71699723|NCT00315445|142914907|SUPERIORITY_OR_OTHER||Day 84 Mean|44.5|||||TWO_SIDED|90.0|43.3|52.4|||Day 84 Mean|||||52.4|43.3|
71699724|NCT00315445|142914907|SUPERIORITY_OR_OTHER||Day 84 Mean|46.5|||||TWO_SIDED|90.0|41.7|50.2|||Day 84 Mean|||||50.2|41.7|
71699725|NCT00315445|142914908|SUPERIORITY_OR_OTHER||Day 84 Mean|18.9|||||TWO_SIDED|90.0|5.2|26.2|||Day 84 Mean|||||26.2|5.2|
71699726|NCT00315445|142914908|SUPERIORITY_OR_OTHER||Day 84 Mean|24.4|||||TWO_SIDED|90.0|10.7|32.0|||Day 84 Mean|||||32.0|10.7|
71699727|NCT00315445|142914908|SUPERIORITY_OR_OTHER||Day 84 Mean|33.9|||||TWO_SIDED|90.0|16.0|35.2|||Day 84 Mean|||||35.2|16.0|
71699728|NCT00315445|142914909|SUPERIORITY_OR_OTHER|||||||0.0452||||||Multiple linear regression|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P \< 0.10, using a backward elimination procedure.||||0.0452
71699729|NCT00315445|142914909|SUPERIORITY_OR_OTHER|||||||0.0962|||||||Mixed Models Analysis|||||||0.0962
71699730|NCT00315445|142914910|SUPERIORITY_OR_OTHER||Day 84 Mean|35.3|||||TWO_SIDED|90.0|24.3|35.6|||Day 84 Mean|||||35.6|24.3|
71699731|NCT00315445|142914910|SUPERIORITY_OR_OTHER||Day 84 Mean|39.0|||||TWO_SIDED|90.0|29.0|40.3|||Day 84 Mean|||||40.3|29.0|
71699732|NCT00315445|142914910|SUPERIORITY_OR_OTHER||Day 84 Mean|41.9|||||TWO_SIDED|90.0|32.1|42.5|||Day 84 Mean|||||42.5|32.1|
71699733|NCT00315445|142914911|SUPERIORITY_OR_OTHER||Day 84 Mean|52.4||||||90.0|50.3|56.6|||Day 84 Mean|||||56.6|50.3|
71699734|NCT00315445|142914911|SUPERIORITY_OR_OTHER||Day 84 Mean|52.5|||||TWO_SIDED|90.0|51.8|58.3|||Day 84 Mean|||||58.3|51.8|
71699735|NCT00315445|142914911|SUPERIORITY_OR_OTHER||Day 84 Mean|57.7|||||TWO_SIDED|90.0|52.3|58.6|||Day 84 Mean|||||58.6|52.3|
71699736|NCT00315445|142914914|SUPERIORITY_OR_OTHER||Day 84 Mean|55.3|||||TWO_SIDED|90.0|49.8|67.9|||Day 84 Mean|||||67.9|49.8|
71699737|NCT00315445|142914914|SUPERIORITY_OR_OTHER||Day 84 Mean|56.3|||||TWO_SIDED|90.0|45.9|65.3|||Day 84 Mean|||||65.3|45.9|
71699738|NCT00315445|142914914|SUPERIORITY_OR_OTHER||Day 84 Mean|63.0|||||TWO_SIDED|90.0|53.1|70.9|||Day 84 Mean|||||70.9|53.1|
71699739|NCT00315445|142914915|SUPERIORITY_OR_OTHER||Day 84 Mean|67.4|||||TWO_SIDED|90.0|61.3|68.6|||Day 84 Mean|||||68.6|61.3|
71699740|NCT00315445|142914915|SUPERIORITY_OR_OTHER||Day 84 Mean|68.8|||||TWO_SIDED|90.0|61.7|68.8|||Day 84 Mean|||||68.8|61.7|
71699741|NCT00315445|142914915|SUPERIORITY_OR_OTHER||Day 84 Mean|67.8|||||TWO_SIDED|90.0|62.0|68.7|||Day 84 Mean|||||68.7|62.0|
71699742|NCT00315445|142914920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.67||||0.054|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.054
71699743|NCT00315445|142914920|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51||||0.138|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.138
71699744|NCT00315445|142914921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.3||||0.0105|||||||Regression, Cox|For the secondary outcomes no alpha adjustment for multiple comparison was performed.||||||0.0105
71699745|NCT00315445|142914921|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.04||||0.0024|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.||||||0.0024
71699746|NCT00315445|142914922|SUPERIORITY_OR_OTHER|||||||0.033|||||||Mixed Models Analysis|||||||.033
71699747|NCT00315445|142914922|SUPERIORITY_OR_OTHER|||||||0.043|||||||Mixed Models Analysis|||||||.043
71699748|NCT00315445|142914923|SUPERIORITY_OR_OTHER|||||||0.011|||||||Mixed Models Analysis|||||||.011
71699749|NCT00315445|142914923|SUPERIORITY_OR_OTHER|||||||0.034|||||||Mixed Models Analysis|||||||.034
71699750|NCT00315445|142914924|SUPERIORITY_OR_OTHER|||||||0.038|||||||Mixed Models Analysis|||||||.038
71699751|NCT00315445|142914924|SUPERIORITY_OR_OTHER|||||||0.63|||||||Mixed Models Analysis|||||||0.63
71699752|NCT00315445|142914925|SUPERIORITY_OR_OTHER|||||||0.064|||||||Mixed Models Analysis|||||||.064
71699753|NCT00315445|142914925|SUPERIORITY_OR_OTHER|||||||0.066|||||||Mixed Models Analysis|||||||.066
71699754|NCT00315445|142914926|SUPERIORITY_OR_OTHER|||||||0.607|||||||Mixed Models Analysis|||||||.607
71699755|NCT00315445|142914926|SUPERIORITY_OR_OTHER|||||||0.94|||||||Mixed Models Analysis|||||||.940
71699756|NCT00315445|142914927|SUPERIORITY_OR_OTHER|||||||0.702|||||||Mixed Models Analysis|||||||.702
71699757|NCT00315445|142914927|SUPERIORITY_OR_OTHER|||||||0.634|||||||Mixed Models Analysis|||||||.634
71699758|NCT01811238|142914945|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_DEVIATION|2.18|<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."||||||<0.05
71699759|NCT01811238|142914946|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_DEVIATION|0.37|<|0.05|TWO_SIDED|95.0|0.0|1.12|||t-test, 2 sided|The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.||||1.12|0|<0.05
71699760|NCT02164916|142914953|SUPERIORITY||Hazard Ratio (HR)|0.48||||0.001|TWO_SIDED|95.0|0.31|0.75|||Log Rank|||||0.75|0.31|0.001
71699761|NCT03479905|142914985|SUPERIORITY|||||||0.0004|||||||Kruskal-Wallis|||||||0.0004
71699762|NCT00720759|142914986|SUPERIORITY_OR_OTHER||Slope|0.83|STANDARD_ERROR_OF_MEAN|8.54|<|0.05|TWO_SIDED|95.0|||||Regression, Linear|||A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.||||<0.05
71699763|NCT02598661|142915002|SUPERIORITY||Percentage Difference|24.8|||<|0.001|TWO_SIDED|95.0|9.9|36.89||The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\[vs.\]\>6 units RBC) \& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||36.89|9.90|<0.001
71699764|NCT02598661|142915004|SUPERIORITY||Percentage Difference|24.6|||<|0.001|TWO_SIDED|95.0|12.64|34.18||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||The 95% CI was calculated based on the Wilson Score method.|||34.18|12.64|<0.001
71699765|NCT02598661|142915007|SUPERIORITY||Hazard Ratio (HR)|0.25|||<|0.001|TWO_SIDED|95.0|0.105|0.586||The p-value (2-sided) was calculated using the stratified log-rank test for superiority of imetelstat sodium versus placebo in hazard ratio.|Log Rank||Hazard ratio and 95% CI were calculated using the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||0.586|0.105|<0.001
71699766|NCT02598661|142915008|SUPERIORITY||Percentage Difference|11.9||||0.112|TWO_SIDED|95.0|-4.1|27.56||The p-value was calculated based on CMH controlling for prior RBC transfusion burden (≤ 6 vs. \> 6 units RBC) and IPSS risk group (low vs. intermediate-1) applied to randomization.|Cochran-Mantel-Haenszel||95% CI was calculated based on the Wilson Score Method.|||27.56|-4.10|0.112
71699767|NCT02598661|142915011|SUPERIORITY||Hazard Ratio (HR)|0.98||||0.949|TWO_SIDED|95.0|0.526|1.823||P value (two-sided) for superiority of imetelstat sodium versus placebo in hazard ratio was calculated using stratified log-rank test.|Log Rank||Hazard ratio and 95% CI were calculated from the Cox proportional hazard model, stratified by prior RBC transfusion burden (≤6 vs. \>6 units RBC) and IPSS risk group (low vs. intermediate-1), with treatment as the only covariate.|||1.823|0.526|0.949
71699768|NCT04761822|142915114|SUPERIORITY||Risk Difference (RD)|0.026||||0.066|TWO_SIDED|95.0|-0.002|0.06||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.060|-0.002|0.066
71699769|NCT04761822|142915115|SUPERIORITY||Risk Difference (RD)|0.012||||0.267|TWO_SIDED|95.0|-0.016|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.016|0.267
71699770|NCT04761822|142915116|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
71699771|NCT04761822|142915117|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
71699772|NCT04761822|142915118|SUPERIORITY||Risk Difference (RD)|0.016||||0.165|TWO_SIDED|95.0|-0.011|0.046|||Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.046|-0.011|0.165
71699773|NCT04761822|142915119|SUPERIORITY||Risk Difference (RD)|0.006||||0.572|TWO_SIDED|95.0|-0.021|0.033||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.033|-0.021|0.572
71699774|NCT04761822|142915120|SUPERIORITY||Risk Difference (RD)|0.015||||0.4574|TWO_SIDED|95.0|-0.045|0.055||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.055|-0.045|0.4574
71699775|NCT04761822|142915121|SUPERIORITY||Risk Difference (RD)|-0.016||||0.3242|TWO_SIDED|95.0|-0.086|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their first active dose as their first injection proportion minus the participants that received their first active dose as their second injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.086|0.3242
71699776|NCT04761822|142915122|SUPERIORITY||Risk Difference (RD)|0.024||||0.31|TWO_SIDED|95.0|-0.037|0.07||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.070|-0.037|0.3100
71699777|NCT04761822|142915123|SUPERIORITY||Risk Difference (RD)|-0.007||||0.807|TWO_SIDED|95.0|-0.0783|0.0366||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the participants that received their second active dose as their second injection proportion minus the participants that received their second active dose as their third injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.0366|-0.0783|0.8070
71699778|NCT04761822|142915124|SUPERIORITY||Risk Difference (RD)|0.001||||1|TWO_SIDED|95.0|-0.04|0.042||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Pfizer-BioNTech COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.042|-0.040|1.000
71699779|NCT04761822|142915125|SUPERIORITY||Risk Difference (RD)|-0.015||||0.25|TWO_SIDED|95.0|-0.053|0.018||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the Moderna COVID-19 vaccine first injection proportion minus comparison placebo first injection proportion, is not statistically different from 0 (i.e. there is no difference).||0.018|-0.053|0.250
71699780|NCT04761822|142915126|SUPERIORITY||Risk Difference (RD)|0.058||||0.004|TWO_SIDED|95.0|0.024|0.101||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.101|0.024|0.004
71699781|NCT04761822|142915127|SUPERIORITY||Risk Difference (RD)|0.075|||<|0.001|TWO_SIDED|95.0|0.039|0.124||Two-sided test using the central method of doubling the one-sided p-value.|Barnard's Exact Unconditional Test|||The null hypothesis is that the risk difference, where the difference is represented as the high allergy/mast cell disorder cohort proportion minus comparison cohort proportion, is not statistically different from 0 (i.e. there is no difference).||0.124|0.039|<0.001
71699782|NCT00090103|142915142|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.8||||0.18||95.0|0.58|1.11||Log-rank test with stratification by cluster.|Log Rank|||||1.11|0.58|0.18
71699783|NCT00090103|142915142|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.34|||<|0.001||95.0|0.26|0.45||Log-rank test with stratification by cluster.|Log Rank|||||0.45|0.26|<0.001
71699784|NCT00090103|142915144|SUPERIORITY_OR_OTHER|||||||0.18||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||0.18
71699785|NCT00090103|142915144|SUPERIORITY_OR_OTHER||||||<|0.001||95.0||||Log rank test with stratification by cluster.|Log Rank|||||||<0.001
71699786|NCT00090103|142915146|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.65|||<|0.001||95.0|0.52|0.8|||Log Rank|Log-rank test with stratification by cluster.||||0.80|0.52|<0.001
71699787|NCT00090103|142915146|SUPERIORITY_OR_OTHER||Relative Risk Estimate|0.59|||<|0.001||95.0|0.48|0.72|||Log Rank|||||0.72|0.48|<0.001
71699788|NCT00090103|142915147|SUPERIORITY_OR_OTHER|||||||0.65||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.65
71699789|NCT00090103|142915147|SUPERIORITY_OR_OTHER|||||||0.1||95.0|||||Log Rank|Mantel-Hanenszel test with stratification by cluster.||||||0.10
71699790|NCT00090103|142915148|SUPERIORITY_OR_OTHER|||||||0.95||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.95
71699791|NCT00090103|142915148|SUPERIORITY_OR_OTHER|||||||0.24||95.0|||||Log Rank|Mantel-Haenszel test with stratification by cluster.||||||0.24
71699792|NCT04476043|142915178|SUPERIORITY||Least squares mean (LSM) difference|-2.7|STANDARD_ERROR_OF_MEAN|1.23||0.0277|TWO_SIDED|95.0|-5.2|-0.3|||MMRM|||||-0.3|-5.2|0.0277
71699793|NCT04476043|142915178|SUPERIORITY||LSM difference|-4.4|STANDARD_ERROR_OF_MEAN|1.25||0.0006|TWO_SIDED|95.0|-6.8|-1.9|||MMRM|||||-1.9|-6.8|0.0006
71699794|NCT04476043|142915178|SUPERIORITY||LSM difference|-3.8|STANDARD_ERROR_OF_MEAN|1.22||0.0021|TWO_SIDED|95.0|-6.2|-1.4|||MMRM|||||-1.4|-6.2|0.0021
71699795|NCT04476043|142915179|SUPERIORITY||Odds Ratio (OR)|2.3||||0.0445|TWO_SIDED|95.0|1.0|5.3|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||5.3|1.0|0.0445
71699796|NCT04476043|142915179|SUPERIORITY||Difference in response rate|19.2|STANDARD_ERROR_OF_MEAN|9.35|||||||||||Standard error of difference between response rates was from normal approximation.|||||
71699797|NCT04476043|142915179|SUPERIORITY||Odds Ratio (OR)|2.0||||0.0998|TWO_SIDED|95.0|0.9|4.6|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.6|0.9|0.0998
71699798|NCT04476043|142915179|SUPERIORITY||Difference in response rate|15.4|STANDARD_ERROR_OF_MEAN|9.32|||||||||||Standard error of difference between response rates was from normal approximation.|||||
71699799|NCT04476043|142915179|SUPERIORITY||Odds Ratio (OR)|2.1||||0.0829|TWO_SIDED|95.0|0.9|4.7|||Wald test||Logistic regression model with treatment group and stratification factors (disease severity and geographical region).|||4.7|0.9|0.0829
71699800|NCT04476043|142915179|SUPERIORITY||Difference in response rate|16.4|STANDARD_ERROR_OF_MEAN|9.29|||||||||||Standard error of difference between response rates was from normal approximation.|||||
71699801|NCT02631057|142915189|SUPERIORITY_OR_OTHER||Mean|-2.484|STANDARD_ERROR_OF_MEAN|0.629|<|0.001|TWO_SIDED|95.0|-3.717|-1.251|||Abadie-Imbens|LoS Average Treatment Effect on the Treated (ATET) \[Dabigatran group\], dispersion analysed with Abadie-Imbens's standard error.|The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as \[Dabigatran - Warfarin\] in the matched cohort of matching ratio 1:3.|||-1.251|-3.717|<0.001
71699802|NCT02471339|142915225|SUPERIORITY|||||||0.05|||||||ANCOVA|||Analysis of covariance. Analyses for primary and secondary outcomes were two-tailed and alpha was set to 0.05. An a priori analysis suggested that, to detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group would be needed.||||0.05
71699803|NCT02471339|142915226|SUPERIORITY|||||||0.05|||||||ANCOVA|||||||0.05
71699804|NCT02471339|142915229|SUPERIORITY|||||||0.05|||||||t-test|||||||.05
71699805|NCT02471339|142915233|SUPERIORITY|||||||0.042|||||||ANOVA|||||||0.042
71699806|NCT00303186|142915279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_DEVIATION|7.03|<|0.0001|TWO_SIDED|95.0|2.4|5.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||5.10|2.40|<0.0001
71699807|NCT00303186|142915279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.72|STANDARD_DEVIATION|7.47|<|0.001|TWO_SIDED|95.0|1.65|5.78|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||5.78|1.65|<0.001
71699808|NCT00303186|142915279|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.37|STANDARD_DEVIATION|4.1||0.518|TWO_SIDED|95.0|-1.5|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.76|-1.50|0.518
71699809|NCT00303186|142915280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.72|STANDARD_DEVIATION|27.89|<|0.0001|TWO_SIDED|95.0|12.38|23.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||23.07|12.38|<0.0001
71699810|NCT00303186|142915280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.6|STANDARD_DEVIATION|20.36|<|0.0001|TWO_SIDED|95.0|6.99|18.21|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.21|6.99|<0.0001
71699811|NCT00303186|142915280|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_DEVIATION|18.7||0.833|TWO_SIDED|95.0|-5.7|4.61|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.61|-5.70|0.833
71699812|NCT00303186|142915281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.72|STANDARD_DEVIATION|2.39|<|0.0001|TWO_SIDED|95.0|2.26|3.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.18|2.26|<0.0001
71699813|NCT00303186|142915281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.23|STANDARD_DEVIATION|2.36|<|0.0001|TWO_SIDED|95.0|1.59|2.87|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.87|1.59|<0.0001
71699814|NCT00303186|142915281|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.28|STANDARD_DEVIATION|2.03||0.309|TWO_SIDED|95.0|-0.83|0.27|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.27|-0.83|0.309
71699815|NCT00303186|142915283|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.66|STANDARD_DEVIATION|11.75||0.004|TWO_SIDED|95.0|1.619|8.301|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||8.301|1.619|0.004
71699816|NCT00303186|142915284|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.76|STANDARD_DEVIATION|18.8||0.015|TWO_SIDED|95.0|-12.155|-1.355|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-1.355|-12.155|0.015
71699817|NCT00303186|142915285|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.44|STANDARD_DEVIATION|7.41||0.676|TWO_SIDED|95.0|-1.666|2.546|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.546|-1.666|0.676
71699818|NCT00303186|142915286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.486|STANDARD_DEVIATION|2.96|<|0.0001|TWO_SIDED|95.0|0.918|2.05|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||2.05|0.918|<0.0001
71699819|NCT00303186|142915286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.0|STANDARD_DEVIATION|3.64|<|0.001|TWO_SIDED|95.0|1.01|2.99|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||2.99|1.01|<0.001
71699820|NCT00303186|142915286|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.56|STANDARD_DEVIATION|3.32||0.223|TWO_SIDED|95.0|-0.35|1.46|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.46|-0.35|0.223
71699821|NCT00303186|142915287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.33|STANDARD_DEVIATION|5.94|<|0.0001|TWO_SIDED|95.0|5.1|7.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 12: swollen joints.||7.47|5.10|<0.0001
71699822|NCT00303186|142915287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.2|STANDARD_DEVIATION|6.35|<|0.0001|TWO_SIDED|95.0|4.48|7.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 60: swollen joints.||7.92|4.48|<0.0001
71699823|NCT00303186|142915287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.2|STANDARD_DEVIATION|2.09||0.479|TWO_SIDED|95.0|-0.36|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: swollen joints and Month 60: swollen joints.||0.76|-0.36|0.479
71699824|NCT00303186|142915287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.0|STANDARD_DEVIATION|11.16|<|0.0001|TWO_SIDED|95.0|6.86|11.13|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 12: tender joints.||11.13|6.86|<0.0001
71699825|NCT00303186|142915287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.6|STANDARD_DEVIATION|9.25|<|0.0001|TWO_SIDED|95.0|6.1|11.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 60: tender joints.||11.10|6.10|<0.0001
71699826|NCT00303186|142915287|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.66|STANDARD_DEVIATION|8.92||0.588|TWO_SIDED|95.0|-1.76|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: tender joints and Month 60: tender joints.||3.07|-1.76|0.588
71699827|NCT00303186|142915291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.26|STANDARD_DEVIATION|11.29||0.33|TWO_SIDED|95.0|-1.3|3.82|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||3.82|-1.30|0.330
71699828|NCT00303186|142915291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-8.56|STANDARD_DEVIATION|32.28||0.449|TWO_SIDED|95.0|-33.37|16.26|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||16.26|-33.37|0.449
71699829|NCT00303186|142915291|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.0|STANDARD_DEVIATION|38.17||0.165|TWO_SIDED|95.0|-37.04|7.04|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.04|-37.04|0.165
71699830|NCT00303186|142915292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|24.48|<|0.0001|TWO_SIDED|95.0|26.44|35.91|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||35.91|26.44|<0.0001
71699831|NCT00303186|142915292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.76|STANDARD_DEVIATION|23.24|<|0.0001|TWO_SIDED|95.0|22.42|35.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||35.10|22.42|<0.0001
71699832|NCT00303186|142915292|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.05|STANDARD_DEVIATION|24.6||0.538|TWO_SIDED|95.0|-8.7|4.6|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||4.60|-8.70|0.538
71699833|NCT00303186|142915293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.83|STANDARD_DEVIATION|19.6|<|0.0001|TWO_SIDED|95.0|30.04|37.63|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||37.63|30.04|<0.0001
71699834|NCT00303186|142915293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|38.04|STANDARD_DEVIATION|21.17|<|0.0001|TWO_SIDED|95.0|31.96|44.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||44.12|31.96|<0.0001
71699835|NCT00303186|142915293|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.38|STANDARD_DEVIATION|17.59||0.343|TWO_SIDED|95.0|-2.62|7.38|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||7.38|-2.62|0.343
71699836|NCT00303186|142915294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|31.18|STANDARD_DEVIATION|27.56|<|0.0001|TWO_SIDED|95.0|25.88|36.49|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||36.49|25.88|<0.0001
71699837|NCT00303186|142915294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|28.8|STANDARD_DEVIATION|25.89|<|0.0001|TWO_SIDED|95.0|21.52|36.09|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||36.09|21.52|<0.0001
71699838|NCT00303186|142915294|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.33|STANDARD_DEVIATION|22.77||0.301|TWO_SIDED|95.0|-9.74|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||3.07|-9.74|0.301
71699839|NCT00303186|142915295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.21|STANDARD_DEVIATION|123.2|<|0.0001|TWO_SIDED|95.0|2.01|50.4|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||50.40|2.01|<0.0001
71699840|NCT00303186|142915295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.19|STANDARD_DEVIATION|18.3|<|0.0001|TWO_SIDED|95.0|7.81|18.57|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||18.57|7.81|<0.0001
71699841|NCT00303186|142915295|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.31|STANDARD_DEVIATION|14.07||0.132|TWO_SIDED|95.0|-6.4|1.77|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||1.77|-6.40|0.132
71699842|NCT00303186|142915296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.26|STANDARD_DEVIATION|150.1|<|0.0005|TWO_SIDED|95.0|-13.52|46.04|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.||46.04|-13.52|<0.0005
71699843|NCT00303186|142915296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|52.81|STANDARD_DEVIATION|100.25|<|0.0001|TWO_SIDED|95.0|22.33|83.29|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.||83.29|22.33|<0.0001
71699844|NCT00303186|142915296|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|33.4|STANDARD_DEVIATION|147.25||0.034|TWO_SIDED|95.0|-10.84|77.64|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.||77.64|-10.84|0.034
71699845|NCT00303186|142915298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.48|STANDARD_DEVIATION|0.66|<|0.0001|TWO_SIDED|95.0|0.35|0.62|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.62|0.35|<0.0001
71699846|NCT00303186|142915298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.41|STANDARD_DEVIATION|0.56|<|0.0001|TWO_SIDED|95.0|0.26|0.56|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||0.56|0.26|<0.0001
71699847|NCT00303186|142915298|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_DEVIATION|0.61||0.6|TWO_SIDED|95.0|-0.24|0.14|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.14|-0.24|0.600
71699848|NCT00303186|142915299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.25|STANDARD_DEVIATION|0.31|<|0.0001|TWO_SIDED|95.0|0.18|0.3|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||0.30|0.18|<0.0001
71699849|NCT00303186|142915299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.22|STANDARD_DEVIATION|0.34|<|0.0001|TWO_SIDED|95.0|-0.31|-0.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-0.12|-0.31|<0.0001
71699850|NCT00303186|142915299|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_DEVIATION|0.27||0.789|TWO_SIDED|95.0|-0.08|0.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||0.06|-0.08|0.789
71699851|NCT00303186|142915300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.4|STANDARD_DEVIATION|25.0|<|0.0001|TWO_SIDED|95.0|14.59|24.22|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.||24.22|14.59|<0.0001
71699852|NCT00303186|142915300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.68|STANDARD_DEVIATION|22.08||0.0001|TWO_SIDED|95.0|-18.77|-6.59|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.||-6.59|-18.77|0.0001
71699853|NCT00303186|142915300|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.85|STANDARD_DEVIATION|22.22||0.115|TWO_SIDED|95.0|-1.21|10.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.||10.92|-1.21|0.115
71699854|NCT00303186|142915301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.41|STANDARD_DEVIATION|10.1|<|0.0001|TWO_SIDED|95.0|-10.34|-4.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 12: physical component score.||-4.47|-10.34|<0.0001
71699855|NCT00303186|142915301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.94|STANDARD_DEVIATION|9.13|<|0.0001|TWO_SIDED|95.0|-8.56|-3.32|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 60: physical component score.||-3.32|-8.56|<0.0001
71699856|NCT00303186|142915301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.25|STANDARD_DEVIATION|8.83||0.308|TWO_SIDED|95.0|-1.19|3.68|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: physical component score and Month 60: physical component score.||3.68|-1.19|0.308
71699857|NCT00303186|142915301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.67|STANDARD_DEVIATION|8.51||0.589|TWO_SIDED|95.0|-3.14|1.8|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 12: mental component score.||1.80|-3.14|0.589
71699858|NCT00303186|142915301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.59|STANDARD_DEVIATION|12.29||0.003|TWO_SIDED|95.0|-9.12|-2.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 60: mental component score.||-2.06|-9.12|0.003
71699859|NCT00303186|142915301|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.7|STANDARD_DEVIATION|12.8||0.002|TWO_SIDED|95.0|-9.23|-2.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: mental component score and Month 60: mental component score.||-2.18|-9.23|0.002
71699860|NCT00267670|142915303|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.0|STANDARD_ERROR_OF_MEAN|1.0||0.46|||||||ANOVA|||Sample size estimates were based on 30% reduction in ALT in the treatment group \& 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), \& a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, \& accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.||||0.46
71699861|NCT00267670|142915304|SUPERIORITY_OR_OTHER|||||||0.16||95.0|||||t-test, 2 sided|||Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.||||0.16
71699862|NCT00267670|142915305|SUPERIORITY_OR_OTHER|||||||0.94|||||||t-test, 2 sided|||||||0.94
71699863|NCT00267670|142915306|SUPERIORITY_OR_OTHER|||||||0.49|||||||t-test, 2 sided|||||||0.49
71699864|NCT02326883|142915307|SUPERIORITY||Cox Proportional Hazard|1.07|STANDARD_ERROR_OF_MEAN|0.12||0.61|TWO_SIDED|95.0|0.86|1.33||A priori two-sided comparison of Care Management condition to Usual Care|Log Rank|A priori Bonferonni-corrected threshold for statistical significance was 0.025.|To clarify direction of comparison: relative hazard of suicide attempt among participants assigned to Care Management was 1.07 (95% CI 0.86 - 1.33) higher compared to participants assigned to Usual Care|Comparison of participants assigned to Care Management intervention to those assigned to continued Usual Care||1.33|0.86|0.61
71699865|NCT02326883|142915307|SUPERIORITY|A priori two-sided comparison of Skills Training to usual care.|Cox Proportional Hazard|1.29|STANDARD_ERROR_OF_MEAN|0.14||0.02|TWO_SIDED|95.0|1.05|1.59||A priori Bonferonni-corrected threshold for statistical significance was 0.025.|Log Rank||To clarify direction of comparison: relative hazard of suicide attempt in participants assigned to Skills Training was 1.29 (95% CI 1.05-1.59) times higher than in those assigned to Usual Care|Comparison of Skills Training to Usual Care||1.59|1.05|0.02
71699866|NCT02469857|142915351|SUPERIORITY|||||||0.135|||||||Chi-squared|||This analysis utilized the mITT analysis population.||||0.135
71699867|NCT02469857|142915351|SUPERIORITY|||||||0.025|||||||Chi-squared|||This analysis utilized the US-mITT analysis population.||||0.025
71699868|NCT02469857|142915355|SUPERIORITY|||||||0.069|||||||Chi-squared|||||||0.069
71699869|NCT02469857|142915356|SUPERIORITY|||||||0.401|||||||Wilcoxon (Mann-Whitney)|||||||0.401
71699870|NCT02469857|142915357|SUPERIORITY|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||||||0.195
71699871|NCT02469857|142915358|SUPERIORITY|||||||0.596|||||||Wilcoxon (Mann-Whitney)|||||||0.596
71699872|NCT02469857|142915359|SUPERIORITY|||||||0.512|||||||Wilcoxon (Mann-Whitney)|||||||0.512
71699873|NCT02469857|142915360|SUPERIORITY|||||||0.033|||||||Chi-squared|||||||0.033
71699874|NCT02469857|142915361|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.554|TWO_SIDED|95.0|0.5|1.46|||Log Rank|||||1.46|0.50|0.554
71699875|NCT02469857|142915362|SUPERIORITY||Hazard Ratio (HR)|0.54||||0.148|TWO_SIDED|95.0|0.23|1.26|||Log Rank|||||1.26|0.23|0.148
71699876|NCT02469857|142915363|SUPERIORITY||Hazard Ratio (HR)|0.89||||0.736|TWO_SIDED|95.0|0.46|1.73|||Log Rank|||||1.73|0.46|0.736
71699877|NCT02469857|142915364|SUPERIORITY||Hazard Ratio (HR)|0.34||||0.093|TWO_SIDED|95.0|0.09|1.25|||Log Rank|||||1.25|0.09|0.093
71699878|NCT02469857|142915365|SUPERIORITY||Hazard Ratio (HR)|0.71||||0.352|TWO_SIDED|95.0|0.35|1.46|||Log Rank|||||1.46|0.35|0.352
71699879|NCT02469857|142915366|SUPERIORITY||Hazard Ratio (HR)|0.21||||0.031|TWO_SIDED|95.0|0.04|0.99|||Log Rank|||||0.99|0.04|0.031
71699880|NCT02469857|142915367|SUPERIORITY|||||||0.024|||||||Chi-squared|||||||0.024
71699881|NCT02469857|142915368|SUPERIORITY|||||||0.007|||||||Chi-squared|||||||0.007
71699882|NCT02469857|142915369|SUPERIORITY|||||||0.034|||||||Chi-squared|||||||0.034
71699883|NCT02469857|142915370|SUPERIORITY|||||||0.003|||||||Chi-squared|||||||0.003
71699884|NCT02110693|142915371|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.64|0.75||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.75|.64|
71699885|NCT02110693|142915371|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.74|||||TWO_SIDED|95.0|0.68|0.79||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.79|.68|
71699886|NCT02110693|142915372|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.71|||||TWO_SIDED|95.0|0.63|0.79||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.79|.63|
71699887|NCT02110693|142915372|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||TWO_SIDED|95.0|0.62|0.77||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.77|.62|
71699888|NCT02110693|142915373|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.57|||||TWO_SIDED|95.0|0.47|0.67||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.67|.47|
71699889|NCT02110693|142915373|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.6|||||TWO_SIDED|95.0|0.5|0.69||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.||.69|.50|
71699890|NCT02110693|142915374|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
71699891|NCT02110693|142915374|OTHER|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|Sensivity|0.66|||||TWO_SIDED|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.77|.53|
71699892|NCT02110693|142915378|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.|Spearman Correlation|0.63|||||TWO_SIDED|95.0|0.59|0.66|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.66|.59|
71699893|NCT02110693|142915378|OTHER|The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.|Spearman Correlation|0.64|||||TWO_SIDED|95.0|0.61|0.68|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) was tested separately against the reference measure.||.68|.61|
71699894|NCT02110693|142915380|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.|Spearman Correlation|0.29|||||TWO_SIDED|95.0|0.25|0.33|||||The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.||.33|.25|
71699895|NCT02110693|142915380|OTHER||Spearman Correlation|0.28|||||TWO_SIDED|95.0|0.24|0.32|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.32|.24|
71699896|NCT02110693|142915381|OTHER|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.|Spearman Correlation|0.42|||||TWO_SIDED|95.0|0.35|0.48|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.||.48|.35|
71699897|NCT02110693|142915381|OTHER||Spearman Correlation|0.4|||||TWO_SIDED|95.0|0.33|0.46|||||The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.|||.46|.33|
71699898|NCT04810962|142915382|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699899|NCT04810962|142915383|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699900|NCT04810962|142915385|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699901|NCT04810962|142915386|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699902|NCT04810962|142915387|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699903|NCT04810962|142915388|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699904|NCT04810962|142915389|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699905|NCT04810962|142915390|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699906|NCT04810962|142915391|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699907|NCT04810962|142915392|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699908|NCT04810962|142915393|SUPERIORITY||Mean Difference (Net)|-1.2|||<|0.001|TWO_SIDED|95.0|-1.4|-1.0|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-1.0|-1.4|<0.001
71699909|NCT04810962|142915394|SUPERIORITY||Mean Difference (Net)|-0.5|||<|0.001|TWO_SIDED|95.0|-0.7|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.7|<0.001
71699910|NCT04810962|142915395|SUPERIORITY||Mean Difference (Net)|-0.4|||<|0.001|TWO_SIDED|95.0|-0.5|-0.3|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.3|-0.5|<0.001
71699911|NCT04810962|142915396|SUPERIORITY||Mean Difference (Net)|-0.05|||<|0.001|TWO_SIDED|95.0|-0.07|-0.02|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.02|-0.07|<0.001
71699912|NCT04810962|142915397|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.1|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.10|<0.001
71699913|NCT04810962|142915398|SUPERIORITY||Mean Difference (Net)|-0.08|||<|0.001|TWO_SIDED|95.0|-0.11|-0.05|||ANCOVA||Treatment Difference = APP13007-Placebo. Mean Difference Is the least-squares mean difference from the ANCOVA model with treatment as a fixed effect and baseline as a covariate.|||-0.05|-0.11|<0.001
71699914|NCT04810962|142915399|SUPERIORITY||||||<|0.001|||||||Chi-squared|||||||<0.001
71699915|NCT00142415|142915416|OTHER|The maximum tolerated dose (MTD) was determined using a standard 3 + 3 dose-escalation design. The occurrence of DLTs was compared across cohorts.|Maximum tolerated dose (mCi/m^2)|65.0|||||TWO_SIDED|||||||||||||
71699916|NCT03620162|142915427|OTHER|Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.525|TWO_SIDED|95.0|-13.6|7.0|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 5 vs 1)||7.0|-13.6|= 0.525
71699917|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.5|||=|0.396|TWO_SIDED|95.0|-14.7|5.8|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 4 vs 1)||5.8|-14.7|= 0.396
71699918|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.097|TWO_SIDED|95.0|-18.8|1.6|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 3 vs 1)||1.6|-18.8|= 0.097
71699919|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.9|||=|0.057|TWO_SIDED|95.0|-19.9|0.3|||Miettinen & Nurminen method|||Difference in Percentage: Erythema(Group 2 vs 1)||0.3|-19.9|= 0.057
71699920|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.4|||=|0.085|TWO_SIDED|95.0|-17.8|1.2|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 5 vs 1)||1.2|-17.8|= 0.085
71699921|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-9.5|||=|0.05|TWO_SIDED|95.0|-18.9|0.0|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 4 vs 1)||-0.0|-18.9|= 0.050
71699922|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.5|||=|0.183|TWO_SIDED|95.0|-16.1|3.1|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 3 vs 1)||3.1|-16.1|= 0.183
71699923|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.7|||=|0.074|TWO_SIDED|95.0|-18.1|0.8|||Miettinen & Nurminen method|||Difference in Percentage: Induration(Group 2 vs 1)||0.8|-18.1|= 0.074
71699924|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.525|TWO_SIDED|95.0|-7.0|13.6|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 5 vs 1)||13.6|-7.0|= 0.525
71699925|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.915|TWO_SIDED|95.0|-10.8|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 4 vs 1)||9.7|-10.8|= 0.915
71699926|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.9|||=|0.714|TWO_SIDED|95.0|-8.4|12.2|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 3 vs 1)||12.2|-8.4|= 0.714
71699927|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.5|||=|0.926|TWO_SIDED|95.0|-10.7|9.7|||Miettinen & Nurminen method|||Difference in Percentage: Tenderness(Group 2 vs 1)||9.7|-10.7|= 0.926
71699928|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-8.7|8.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 5 vs 1)||8.7|-8.7|> 0.999
71699929|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-2.2|||=|0.609|TWO_SIDED|95.0|-10.8|6.4|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 4 vs 1)||6.4|-10.8|= 0.609
71699930|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.8|||=|0.688|TWO_SIDED|95.0|-7.1|10.7|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 3 vs 1)||10.7|-7.1|= 0.688
71699931|NCT03620162|142915427|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.1|||=|0.336|TWO_SIDED|95.0|-12.6|4.3|||Miettinen & Nurminen method|||Difference in Percentage: Swelling(Group 2 vs 1)||4.3|-12.6|= 0.336
71699932|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.1|||=|0.825|TWO_SIDED|95.0|-11.0|8.8|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group5 vs1)||8.8|-11.0|= 0.825
71699933|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.912|TWO_SIDED|95.0|-10.4|9.3|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group4 vs1)||9.3|-10.4|= 0.912
71699934|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-8.8|||=|0.074|TWO_SIDED|95.0|-18.3|0.9|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group3 vs1)||0.9|-18.3|= 0.074
71699935|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Percentage of Participants|-3.7|||=|0.458|TWO_SIDED|95.0|-13.4|6.1|||Miettinen & Nurminen method|||Difference in Percentage:Appetite lost(Group2 vs1)||6.1|-13.4|= 0.458
71699936|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|2.8|||=|0.568|TWO_SIDED|95.0|-6.8|12.3|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 5 vs1)||12.3|-6.8|= 0.568
71699937|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||=|0.91|TWO_SIDED|95.0|-9.1|10.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 4 vs1)||10.2|-9.1|= 0.910
71699938|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-4.7|||=|0.354|TWO_SIDED|95.0|-14.5|5.2|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 3 vs1)||5.2|-14.5|= 0.354
71699939|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-6.8|||=|0.178|TWO_SIDED|95.0|-16.6|3.1|||Miettinen & Nurminen method|||Difference in Percentage:Irritability(Group 2 vs1)||3.1|-16.6|= 0.178
71699940|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|3.4|||=|0.52|TWO_SIDED|95.0|-6.8|13.5|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 5 vs 1)||13.5|-6.8|= 0.520
71699941|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||>|0.999|TWO_SIDED|95.0|-10.2|10.2|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 4 vs 1)||10.2|-10.2|> 0.999
71699942|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.2|||=|0.963|TWO_SIDED|95.0|-10.5|10.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 3 vs 1)||10.0|-10.5|= 0.963
71699943|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.2|||=|0.821|TWO_SIDED|95.0|-11.4|9.0|||Miettinen & Nurminen method|||Difference in Percentage: Drowsiness(Group 2 vs 1)||9.0|-11.4|= 0.821
71699944|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-0.6|||=|0.836|TWO_SIDED|95.0|-6.1|5.0|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 5 vs 1)||5.0|-6.1|= 0.836
71699945|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|1.7|||=|0.562|TWO_SIDED|95.0|-4.2|7.6|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 4 vs 1)||7.6|-4.2|= 0.562
71699946|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-1.6|||=|0.527|TWO_SIDED|95.0|-7.1|3.7|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 3 vs 1)||3.7|-7.1|= 0.527
71699947|NCT03620162|142915428|OTHER|Estimated differences, CIs, and p-values are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|-3.4|||=|0.16|TWO_SIDED|95.0|-8.6|1.5|||Miettinen & Nurminen method|||Difference in Percentage: Hives(Group 2 vs 1)||1.5|-8.6|= 0.160
71699948|NCT03620162|142915429|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 5 vs 1)||2.1|-2.1|
71699949|NCT03620162|142915429|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 4 vs 1)||2.1|-2.1|
71699950|NCT03620162|142915429|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.6|||||TWO_SIDED|95.0|-1.6|3.1||||||Difference in Percentage (Group 3 vs 1)||3.1|-1.6|
71699951|NCT03620162|142915429|OTHER|Estimated differences and CIs are calculated based on the Miettinen \& Nurminen method and are provided in accordance with the statistical analysis plan.|Difference in Percentage|0.0|||||TWO_SIDED|95.0|-2.1|2.1||||||Difference in Percentage (Group 2 vs 1)||2.1|-2.1|
71699952|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.69|1.0||||||GMC Ratio: Serotype 1 (Group 4 vs 1)||1.00|0.69|
71699953|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.12||||||GMC Ratio: Serotype 1 (Group 3 vs 1)||1.12|0.77|
71699954|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.83|||||TWO_SIDED|95.0|0.7|1.0||||||GMC Ratio: Serotype 1 (Group 2 vs 1)||1.00|0.70|
71699955|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.01|||||TWO_SIDED|95.0|0.86|1.19||||||GMC Ratio: Serotype 3 (Group 4 vs 1)||1.19|0.86|
71699956|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.8|1.12||||||GMC Ratio: Serotype 3 (Group 3 vs 1)||1.12|0.80|
71699957|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.06|||||TWO_SIDED|95.0|0.9|1.25||||||GMC Ratio: Serotype 3 (Group 2 vs 1)||1.25|0.90|
71699958|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.81|||||TWO_SIDED|95.0|0.66|1.0||||||GMC Ratio: Serotype 4 (Group 4 vs 1)||1.00|0.66|
71699959|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.68|1.03||||||GMC Ratio: Serotype 4 (Group 3 vs 1)||1.03|0.68|
71699960|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.08||||||GMC Ratio: Serotype 4 (Group 2 vs 1)||1.08|0.72|
71699961|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.98||||||GMC Ratio: Serotype 5 (Group 4 vs 1)||0.98|0.64|
71699962|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.04|||||TWO_SIDED|95.0|0.84|1.29||||||GMC Ratio: Serotype 5 (Group 3 vs 1)||1.29|0.84|
71699963|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.92|||||TWO_SIDED|95.0|0.75|1.14||||||GMC Ratio: Serotype 5 (Group 2 vs 1)||1.14|0.75|
71699964|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.8|||||TWO_SIDED|95.0|0.66|0.98||||||GMC Ratio: Serotype 6A (Group 4 vs 1)||0.98|0.66|
71699965|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.91|1.37||||||GMC Ratio: Serotype 6A (Group 3 vs 1)||1.37|0.91|
71699966|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.12|||||TWO_SIDED|95.0|0.92|1.36||||||GMC Ratio: Serotype 6A (Group 2 vs 1)||1.36|0.92|
71699967|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.31||||||GMC Ratio: Serotype 6B (Group 4 vs 1)||1.31|0.88|
71699968|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.08|||||TWO_SIDED|95.0|0.88|1.32||||||GMC Ratio: Serotype 6B (Group 3 vs 1)||1.32|0.88|
71699969|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.23|||||TWO_SIDED|95.0|1.02|1.49||||||GMC Ratio: Serotype 6B (Group 2 vs 1)||1.49|1.02|
71699970|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.78|||||TWO_SIDED|95.0|0.64|0.95||||||GMC Ratio: Serotype 7F (Group 4 vs 1)||0.95|0.64|
71699971|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.81|1.21||||||GMC Ratio: Serotype 7F (Group 3 vs 1)||1.21|0.81|
71699972|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.11|||||TWO_SIDED|95.0|0.92|1.35||||||GMC Ratio: Serotype 7F (Group 2 vs 1)||1.35|0.92|
71699973|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.7|1.01||||||GMC Ratio: Serotype 9V (Group 4 vs 1)||1.01|0.70|
71699974|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.73|1.06||||||GMC Ratio: Serotype 9V (Group 3 vs 1)||1.06|0.73|
71699975|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.79|1.13||||||GMC Ratio: Serotype 9V (Group 2 vs 1)||1.13|0.79|
71699976|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.83|1.28||||||GMC Ratio: Serotype 14 (Group 4 vs 1)||1.28|0.83|
71699977|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.43|||||TWO_SIDED|95.0|1.15|1.78||||||GMC Ratio: Serotype 14 (Group 3 vs 1)||1.78|1.15|
71699978|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.39|||||TWO_SIDED|95.0|1.13|1.71||||||GMC Ratio: Serotype 14 (Group 2 vs 1)||1.71|1.13|
71699979|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.07|||||TWO_SIDED|95.0|0.88|1.3||||||GMC Ratio: Serotype 18C (Group 4 vs 1)||1.30|0.88|
71699980|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.44|||||TWO_SIDED|95.0|1.18|1.76||||||GMC Ratio: Serotype 18C (Group 3 vs 1)||1.76|1.18|
71699981|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.51|||||TWO_SIDED|95.0|1.25|1.83||||||GMC Ratio: Serotype 18C (Group 2 vs 1)||1.83|1.25|
71699982|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.84|||||TWO_SIDED|95.0|0.69|1.01||||||GMC Ratio: Serotype 19A (Group 4 vs 1)||1.01|0.69|
71699983|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.88|||||TWO_SIDED|95.0|0.72|1.07||||||GMC Ratio: Serotype 19A (Group 3 vs 1)||1.07|0.72|
71699984|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.93|||||TWO_SIDED|95.0|0.77|1.13||||||GMC Ratio: Serotype 19A (Group 2 vs 1)||1.13|0.77|
71699985|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.96|||||TWO_SIDED|95.0|0.81|1.15||||||GMC Ratio: Serotype 19F (Group 4 vs 1)||1.15|0.81|
71699986|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.05|||||TWO_SIDED|95.0|0.88|1.26||||||GMC Ratio: Serotype 19F (Group 3 vs 1)||1.26|0.88|
71699987|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.02|||||TWO_SIDED|95.0|0.86|1.21||||||GMC Ratio: Serotype 19F (Group 2 vs 1)||1.21|0.86|
71699988|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.77|||||TWO_SIDED|95.0|0.61|0.96||||||GMC Ratio: Serotype 23F (Group 4 vs 1)||0.96|0.61|
71699989|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.63|0.99||||||GMC Ratio: Serotype 23F (Group 3 vs 1)||0.99|0.63|
71699990|NCT03620162|142915430|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.94|||||TWO_SIDED|95.0|0.76|1.17||||||GMC Ratio: Serotype 23F (Group 2 vs 1)||1.17|0.76|
71699991|NCT03620162|142915431|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the difference in percentages (Group 5/Group 1+Group 2) to be \>-10 percentage points.|Difference in Percentage|-0.2|||<|0.001|TWO_SIDED|95.0|-3.7|2.0|||Miettinen & Nurminen method|||Difference in Percentage (Group 5 vs Group 1+2)||2.0|-3.7|< 0.001
71699992|NCT03620162|142915432|NON_INFERIORITY|The statistical criterion for non-inferiority requires the lower bound of the 2-sided 95% CI for the GMT ratio (Group 5/Group 1+Group 2) to be \>0.5.|GMT Ratio|0.97|||<|0.001|TWO_SIDED|95.0|0.7|1.34|||ANCOVA|||GMT Ratio (Group 5 vs Group 1+2)||1.34|0.70|< 0.001
71699993|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.72|||||TWO_SIDED|95.0|0.6|0.86||||||GMC Ratio: Serotype 1 (Group 5 vs 1)||0.86|0.60|
71699994|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.22|||||TWO_SIDED|95.0|1.04|1.44||||||GMC Ratio: Serotype 3 (Group 5 vs 1)||1.44|1.04|
71699995|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.89|||||TWO_SIDED|95.0|0.73|1.1||||||GMC Ratio: Serotype 4 (Group 5 vs 1)||1.10|0.73|
71699996|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.64|0.97||||||GMC Ratio: Serotype 5 (Group 5 vs 1)||0.97|0.64|
71699997|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.69|||||TWO_SIDED|95.0|0.57|0.84||||||GMC Ratio: Serotype 6A (Group 5 vs 1)||0.84|0.57|
71699998|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.95|||||TWO_SIDED|95.0|0.78|1.15||||||GMC Ratio: Serotype 6B (Group 5 vs 1)||1.15|0.78|
71699999|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.67|||||TWO_SIDED|95.0|0.55|0.82||||||GMC Ratio: Serotype 7F (Group 5 vs 1)||0.82|0.55|
71700000|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.99|||||TWO_SIDED|95.0|0.82|1.18||||||GMC Ratio: Serotype 9V (Group 5 vs 1)||1.18|0.82|
71700001|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.7|1.07||||||GMC Ratio: Serotype 14 (Group 5 vs 1)||1.07|0.70|
71700002|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|1.03|||||TWO_SIDED|95.0|0.85|1.25||||||GMC Ratio: Serotype 18C (Group 5 vs 1)||1.25|0.85|
71700003|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.79|||||TWO_SIDED|95.0|0.65|0.95||||||GMC Ratio: Serotype 19A (Group 5 vs 1)||0.95|0.65|
71700004|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.86|||||TWO_SIDED|95.0|0.72|1.02||||||GMC Ratio: Serotype 19F (Group 5 vs 1)||1.02|0.72|
71700005|NCT03620162|142915435|OTHER|GMC ratio and CI are estimated from a serotype-specific ANCOVA model utilizing the natural log-transformed antibody concentration as the response and vaccination group and stratification factor as covariates.|GMC Ratio|0.73|||||TWO_SIDED|95.0|0.59|0.91||||||GMC Ratio: Serotype 23F (Group 5 vs 1)||0.91|0.59|
71700006|NCT03416179|142915450|SUPERIORITY||Hazard Ratio (HR)|1.08||||0.6579|TWO_SIDED|95.0|0.755|1.532|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio less than (\<) 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2 compared to Placebo + Cytarabine 100 mg/m\^2 IV + Daunorubicin 60 mg/m\^2.||1.532|0.755|0.6579
71700007|NCT03416179|142915451|SUPERIORITY||Hazard Ratio (HR)|1.04||||0.5955|TWO_SIDED|95.0|0.775|1.388|||Log Rank|||Hazard ratio based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicated a reduction in hazard rate in favor of Glasdegib 100 mg PO QD + Azacitidine compared to Placebo + Azacitidine||1.388|0.775|0.5955
71700008|NCT03416179|142915452|OTHER|||||||0.5095|||||||Mantel Haenszel|||||||0.5095
71700009|NCT03416179|142915453|OTHER|||||||0.8359|||||||Mantel Haenszel|||||||0.8359
71700010|NCT00846365|142915522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.4|-3.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and Baseline as a covariate.||-3.8|-8.4|<0.001
71700011|NCT00846365|142915522|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.7|||<|0.001|TWO_SIDED|95.0|-9.1|-4.4||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.4|-9.1|<0.001
71700012|NCT00846365|142915523|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.1|||<|0.001|TWO_SIDED|95.0|-8.5|-3.7||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-3.7|-8.5|<0.001
71700013|NCT00846365|142915523|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.6|-4.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.||-4.8|-9.6|<0.001
71700014|NCT00846365|142915527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.6|||<|0.001|TWO_SIDED|95.0|-7.5|-3.7||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-3.7|-7.5|<0.001
71700015|NCT00846365|142915527|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.2|||<|0.001|TWO_SIDED|95.0|-9.1|-5.2||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.||-5.2|-9.1|<0.001
71700016|NCT03454555|142915578|SUPERIORITY||Mean Difference (Final Values)|-5.6||||0.31|TWO_SIDED|95.0|-16.6|5.3|||Mixed Models Analysis|||||5.3|-16.6|0.31
71700017|NCT03454555|142915579|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.963|TWO_SIDED|95.0|-10.3|10.7|||Mixed Models Analysis|||||10.7|-10.3|0.963
71700018|NCT03454555|142915580|SUPERIORITY||Mean Difference (Final Values)|-6.2||||0.253|TWO_SIDED|95.0|-16.8|4.4|||Mixed Models Analysis|||||4.4|-16.8|0.253
71700019|NCT03454555|142915581|SUPERIORITY||Mean Difference (Final Values)|0.7||||0.9|TWO_SIDED|95.0|-10.1|11.5|||Mixed Models Analysis|||||11.5|-10.1|0.90
71700020|NCT03454555|142915582|SUPERIORITY||Mean Difference (Final Values)|-2.6||||0.65|TWO_SIDED|95.0|-13.7|8.6|||Mixed Models Analysis|||||8.6|-13.7|0.65
71700021|NCT03454555|142915583|SUPERIORITY||Mean Difference (Final Values)|9.4||||0.102|TWO_SIDED|95.0|-1.9|20.8|||Mixed Models Analysis|||||20.8|-1.9|0.102
71700022|NCT03454555|142915584|SUPERIORITY||Odds Ratio (OR)|0.93||||0.83|TWO_SIDED|95.0|0.5|1.75|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.75|0.50|0.83
71700023|NCT03454555|142915585|SUPERIORITY||Odds Ratio (OR)|0.79||||0.47|TWO_SIDED|95.0|0.42|1.5|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.50|0.42|0.47
71700024|NCT03454555|142915586|SUPERIORITY||Odds Ratio (OR)|1.02||||0.96|TWO_SIDED|95.0|0.54|1.9|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.90|0.54|0.96
71700025|NCT03454555|142915587|SUPERIORITY||Odds Ratio (OR)|0.71||||0.28|TWO_SIDED|95.0|0.38|1.33|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.33|0.38|0.28
71700026|NCT03454555|142915588|SUPERIORITY||Odds Ratio (OR)|0.9||||0.75|TWO_SIDED|95.0|0.47|1.71|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.71|0.47|0.75
71700027|NCT03454555|142915589|SUPERIORITY||Odds Ratio (OR)|0.68||||0.25|TWO_SIDED|95.0|0.35|1.31|||Mixed Models Analysis|Used a logistic mixed model for repeated measures||||1.31|0.35|0.25
71700028|NCT03454555|142915590|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.7|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.70
71700029|NCT03454555|142915591|SUPERIORITY||Median Difference (Final Values)|0.1||||0.92|TWO_SIDED|95.0|-1.1|1.2|||Mixed Models Analysis|||||1.2|-1.1|0.92
71700030|NCT03454555|142915592|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.64|TWO_SIDED|95.0|-0.7|1.2|||Mixed Models Analysis|||||1.2|-0.7|0.64
71700031|NCT03454555|142915593|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.75|TWO_SIDED|95.0|-0.8|1.1|||Mixed Models Analysis|||||1.1|-0.8|0.75
71700032|NCT03454555|142915594|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.69|TWO_SIDED|95.0|-0.9|1.4|||Mixed Models Analysis|||||1.4|-0.9|0.69
71700033|NCT03454555|142915595|SUPERIORITY||Mean Difference (Final Values)|0.6||||0.33|TWO_SIDED|95.0|-0.6|1.8|||Mixed Models Analysis|||||1.8|-0.6|0.33
71700034|NCT03454555|142915596|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.86|TWO_SIDED|95.0|-1.8|1.5|||Mixed Models Analysis|||||1.5|-1.8|0.86
71700035|NCT03454555|142915597|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.76|TWO_SIDED|95.0|-1.4|1.9|||Mixed Models Analysis|||||1.9|-1.4|0.76
71700036|NCT03454555|142915598|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.55|TWO_SIDED|95.0|-2.0|1.1|||Mixed Models Analysis|||||1.1|-2.0|0.55
71700037|NCT03454555|142915599|SUPERIORITY||Mean Difference (Final Values)|-0.5||||0.52|TWO_SIDED|95.0|-2.1|1.1|||Mixed Models Analysis|||||1.1|-2.1|0.52
71700038|NCT03454555|142915600|SUPERIORITY||Mean Difference (Final Values)|0.1||||0.37|TWO_SIDED|95.0|-0.2|0.4|||Mixed Models Analysis|||||0.4|-0.2|0.37
71700039|NCT03454555|142915601|SUPERIORITY||Mean Difference (Final Values)|0.0||||0.91|TWO_SIDED|95.0|-0.3|0.3|||Mixed Models Analysis|||||0.3|-0.3|0.91
71700040|NCT03454555|142915602|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.33|TWO_SIDED|95.0|-0.2|0.6|||Mixed Models Analysis|||||0.6|-0.2|0.33
71700041|NCT03454555|142915603|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.46|TWO_SIDED|95.0|-0.3|0.6|||Mixed Models Analysis|||||0.6|-0.3|0.46
71700042|NCT03454555|142915604|SUPERIORITY||Risk Difference (RD)|-0.02||||0.52|TWO_SIDED|95.0|-0.08|0.04|||Chi-squared|||||0.04|-0.08|0.52
71700043|NCT03454555|142915605|SUPERIORITY||Odds Ratio (OR)|1.48||||0.17|TWO_SIDED|95.0|0.85|2.59|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.59|0.85|0.17
71700044|NCT03454555|142915606|SUPERIORITY||Odds Ratio (OR)|1.28||||0.41|TWO_SIDED|95.0|0.71|2.31|||Mixed Models Analysis|Used a generalized logistic model for repeated measurements; modeled the outcome of intention to taper.||||2.31|0.71|0.41
71700045|NCT03454555|142915607|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71700046|NCT03454555|142915608|SUPERIORITY|||||||0.67|||||||Chi-squared|||||||0.67
71700047|NCT03643848|142915673|SUPERIORITY||variance components; inferring mean diff|0.068|STANDARD_DEVIATION|0.033|<|0.046|TWO_SIDED|||||a priori threshold p\<.05|Mixed Models Analysis|REML; Satterwaite method for t-tests.Participant is random effect. Addtnl fixed effects: Valence, Condition, Anxiety Severity, Gender, Age (months).||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 1 week. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||<.046
71700048|NCT03643848|142915674|SUPERIORITY||variance components; inferring mean diff|-0.033|STANDARD_ERROR_OF_MEAN|0.064|=|0.61|TWO_SIDED|||||a priori p\<.05|Mixed Models Analysis|included additional fixed effects: Anxiety severity, gender, age (months)||Condition (TMR, Sham) x Valence (Negative, Neutral) predicting Lure Generalization Index at 12 hour test. We hypothesized a significant interaction, with a reduction in negative generalization and an increase in neutral generalization in the TMR condition.||||=.61
71700049|NCT01080261|142915697|NON_INFERIORITY_OR_EQUIVALENCE|Study had 91% statistical power to demonstrate that the 9-month rate for MACE (accounting for an expected 9-month attrition rate of 10%) is less than the performance goal, assuming a 9-month MACE rate of 8.2%.|Percent of patients experiencing a MACE|0.0|||<|0.0001|ONE_SIDED|95.0||4.9|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the percentage of patients experiencing a MACE event (primary endpoint) in the PROMUS Element cohort is less than the predefined performance goal of 24.1% (based on historical outcomes with plain balloon angioplasty \[20.2%\] plus an adjustment of 3.9% for small vessels).||4.9||<0.0001
71700050|NCT02385318|142915709|EQUIVALENCE|85% power of success|Equivalence ratio|1.11|||||TWO_SIDED|90.0|-4.38|14.44|||Yates correction|||||14.44|-4.38|
71700051|NCT02594111|142915711|SUPERIORITY||||||<|0.05|||||||Chi-squared|||||||<0.05
71700052|NCT01126424|142915729|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-20.986||||0.3771|TWO_SIDED|95.0|-68.58|26.607|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||26.607|-68.580|0.3771
71700053|NCT01126424|142915729|SUPERIORITY_OR_OTHER||Least Square Mean Difference|17.508||||0.4487|TWO_SIDED|95.0|-28.854|63.87|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||63.870|-28.854|0.4487
71700054|NCT01126424|142915730|SUPERIORITY_OR_OTHER||Least Square Mean Difference|9.152||||0.0505|TWO_SIDED|95.0|-0.023|18.326|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||18.326|-0.023|0.0505
71700055|NCT01126424|142915730|SUPERIORITY_OR_OTHER||Least Square Mean Difference|1.846||||0.6753|TWO_SIDED|95.0|-7.02|10.713|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||10.713|-7.020|0.6753
71700056|NCT01126424|142915731|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.507||||0.5684|TWO_SIDED|95.0|-2.293|1.279|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||1.279|-2.293|0.5684
71700057|NCT01126424|142915731|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.792||||0.2348|TWO_SIDED|95.0|-2.122|0.538|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.538|-2.122|0.2348
71700058|NCT01126424|142915732|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.04||||0.6275|TWO_SIDED|95.0|-0.208|0.127|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.127|-0.208|0.6275
71700059|NCT01126424|142915732|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-0.046||||0.5361|TWO_SIDED|95.0|-0.194|0.103|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||0.103|-0.194|0.5361
71700060|NCT01126424|142915733|SUPERIORITY_OR_OTHER||Least Square Mean Difference|4.655||||0.6315|TWO_SIDED|95.0|-14.858|24.167|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||24.167|-14.858|0.6315
71700061|NCT01126424|142915733|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-1.457||||0.867|TWO_SIDED|95.0|-18.976|16.062|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||16.062|-18.976|0.8670
71700062|NCT01126424|142915734|SUPERIORITY_OR_OTHER||Least Square Mean Difference|-77.919||||0.5953|TWO_SIDED|95.0|-372.814|216.976|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||216.976|-372.814|0.5953
71700063|NCT01126424|142915734|SUPERIORITY_OR_OTHER||Least Square Mean Difference|157.783||||0.3526|TWO_SIDED|95.0|-182.015|497.581|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."||497.581|-182.015|0.3526
71700064|NCT00248560|142915735|SUPERIORITY_OR_OTHER||Response rate|0.17|||||TWO_SIDED|95.0|0.08|0.32||||||||0.32|0.08|
71700065|NCT01134042|142915747|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.193|||<|0.001|TWO_SIDED|95.0|0.108|0.277|||ANCOVA|||||0.277|0.108|<0.001
71700066|NCT01134042|142915747|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.21|||<|0.001|TWO_SIDED|95.0|0.127|0.294|||ANCOVA|||||0.294|0.127|<0.001
71700067|NCT01134042|142915747|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority is demonstrated if the lower limit of the confidence interval (CI: 0.025, 1-sided significance level) for the mean difference in change from Baseline in clinic visit trough FEV1 of FF 200 µg OD versus FP 500 µg BID was greater than -125 milliliters.|Median Difference (Final Values)|0.018|||||TWO_SIDED|95.0|-0.066|0.102||||||||0.102|-0.066|
71700068|NCT01134042|142915748|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.136||||0.048|TWO_SIDED|95.0|0.001|0.27|||ANCOVA|||||0.270|0.001|0.048
71700069|NCT01134042|142915748|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|0.206||||0.003|TWO_SIDED|95.0|0.073|0.339|||ANCOVA|||||0.339|0.073|0.003
71700070|NCT00393367|142915758|SUPERIORITY_OR_OTHER|||||||0.44||95.0||||The difference in median improvement between treatment groups was expected to be greater than 2.|Wilcoxon (Mann-Whitney)|||||||0.44
71700071|NCT00393367|142915759|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.0||||0.97|TWO_SIDED|95.0|-0.14|0.14|||Chi-squared|||||0.14|-0.14|0.97
71700072|NCT00393367|142915760|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-1.0|STANDARD_ERROR_OF_MEAN|3.0|||TWO_SIDED|95.0|-7.0|6.0|||t-test, 2 sided|||||6|-7|
71700073|NCT00393367|142915761|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.6|||TWO_SIDED|95.0|-3.0|3.0|||t-test, 2 sided|||||3|-3|
71700074|NCT00393367|142915762|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|0.49|||TWO_SIDED|95.0|-1.0|1.0|||t-test, 2 sided|||||1|-1|
71700075|NCT00393367|142915763|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.03||||0.69||95.0|-0.2|0.14|||Chi-squared|||||0.14|-0.20|0.69
71700076|NCT00393367|142915764|SUPERIORITY_OR_OTHER||Risk Difference (RD)|0.22||||0.08|TWO_SIDED|95.0|-0.02|0.47|||Chi-squared|||||0.47|-0.02|0.08
71700077|NCT00393367|142915765|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.14||||0.22|TWO_SIDED|95.0|-0.37|0.08|||Chi-squared|||||0.08|-0.37|0.22
71700078|NCT00393367|142915767|SUPERIORITY_OR_OTHER||Mean Difference (Net)|0.1|STANDARD_ERROR_OF_MEAN|0.36||0.78|TWO_SIDED|95.0|-0.6|0.8|||t-test, 2 sided|||||0.8|-0.6|0.78
71700079|NCT03286504|142915770|SUPERIORITY||proportion difference|0.05||||0.55|TWO_SIDED|95.0|-0.112|0.212|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.212|-0.112|0.55
71700080|NCT03286504|142915771|SUPERIORITY||proportion difference|0.033||||0.71|TWO_SIDED|95.0|-0.145|0.211|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.211|-0.145|0.71
71700081|NCT03286504|142915773|SUPERIORITY||proportion difference|-0.05||||0.65|TWO_SIDED|95.0|-0.269|0.169|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.169|-0.269|0.65
71700082|NCT03286504|142915774|SUPERIORITY||proportion difference|0.226||||0.04|TWO_SIDED|95.0|0.015|0.438|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm|||0.438|0.015|0.04
71700083|NCT03286504|142915775|SUPERIORITY||proportion difference|0.208||||0.03|TWO_SIDED|95.0|0.023|0.393|||Chi-squared||Direction of proportion difference = FANMI arm minus Standard of Care arm.|||0.393|0.023|0.03
71700084|NCT02030600|142915785|SUPERIORITY_OR_OTHER||Treatment ratio|0.7|||<|0.0001|TWO_SIDED|95.0|0.61|0.8|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period"||0.80|0.61|<0.0001
71700085|NCT02030600|142915786|SUPERIORITY_OR_OTHER||Treatment ratio|0.58|||<|0.0001|TWO_SIDED|95.0|0.46|0.74|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period."||0.74|0.46|<0.0001
71700086|NCT02030600|142915787|SUPERIORITY_OR_OTHER|||||||0.3458||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||"Stepwise hierarchical testing procedure:~Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes in the maintenance period."||||0.3458
71700087|NCT02030600|142915789|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of IDeg against IGlar was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%.|Treatment contrast|0.09|||||TWO_SIDED|95.0|-0.04|0.23||||||"Change from baseline in HbA1c at week 32 (treatment period 1). Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a mixed model for repeated measurement (MMRM) with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.23|-0.04|
71700088|NCT02030600|142915789|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%|Treatment contrast|0.06|||||TWO_SIDED|95.0|-0.07|0.18||||||"Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint Change from baseline in HbA1c after 32 weeks of treatment was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a MMRM with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates."||0.18|-0.07|
71700089|NCT01155323|142915791|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.21|0.23|||Mixed Models Analysis||Mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.||0.23|-0.21|
71700090|NCT01155323|142915792|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.19|0.25|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.||0.25|-0.19|
71700091|NCT01155323|142915793|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.22|0.22|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.||0.22|-0.22|
71700092|NCT01155323|142915794|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/-0.50|Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.03|0.01|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.||0.01|-0.03|
71700093|NCT01155323|142915795|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.07|STANDARD_ERROR_OF_MEAN|0.11|||TWO_SIDED|95.0|-0.15|0.29|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.||0.29|-0.15|
71700094|NCT01155323|142915796|NON_INFERIORITY_OR_EQUIVALENCE|Margin = +/- 0.50|Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|0.02|||TWO_SIDED|95.0|-0.01|0.06|||Mixed Models Analysis||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.||0.06|-0.01|
71700095|NCT04154956|142915822|SUPERIORITY||Hazard Ratio (HR)|1.143||||0.8204|TWO_SIDED|95.0|0.864|1.512||One-sided significance level was 0.01|Log Rank||Hazard ratio and confidence intervals (CIs) were computed from a stratified Cox model according to stratification factors as per IRT.|||1.512|0.864|0.8204
71700096|NCT04154956|142915823|SUPERIORITY||Hazard Ratio (HR)|0.846||||0.112|TWO_SIDED|95.0|0.644|1.109||One-sided significance level was 0.00174.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.109|0.644|0.1120
71700097|NCT04154956|142915824|SUPERIORITY||Odds Ratio (OR)|0.88||||0.6972|TWO_SIDED|95.0|0.55|1.42||P-value is provided for information only, there is no statistical inference based on this P-value.|Cochran-Mantel-Haenszel||Odds ratio and its 2-sided CI were provided from a Cochran-Mantel-Haenszel (CMH) test stratified according to the stratification factors.|||1.42|0.55|0.6972
71700098|NCT04154956|142915825|SUPERIORITY||Hazard Ratio (HR)|0.729||||0.0157|TWO_SIDED|95.0|0.546|0.972||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.972|0.546|0.0157
71700099|NCT04154956|142915826|SUPERIORITY||Hazard Ratio (HR)|0.544||||0.0002|TWO_SIDED|95.0|0.388|0.763||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||0.763|0.388|0.0002
71700100|NCT04154956|142915827|SUPERIORITY||Hazard Ratio (HR)|0.735||||0.0305|TWO_SIDED|95.0|0.533|1.014||P-value is provided for information only, there is no statistical inference based on this P-value.|Log Rank||Hazard ratio and CIs were computed from a stratified Cox model according to stratification factors as per IRT.|||1.014|0.533|0.0305
71700101|NCT00460798|142915849|SUPERIORITY_OR_OTHER||Obective Response Rate (Percent)|40.6|||||TWO_SIDED|95.0|35.5|46.0|||||Exact method based on binomial distribution|Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR||46.0|35.5|
71700102|NCT01953237|142915915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.558|||||||Mixed Models Analysis|||||||0.5580
71700103|NCT02320396|142915916|SUPERIORITY_OR_OTHER_LEGACY||Difference in Least Squares (LS) Means|-0.83|||<|0.001|TWO_SIDED|95.0|-1.14|-0.51|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in TNSS was estimated using a constrained longitudinal data analysis (cLDA) model, where both BL and post-BL measurements (average score of 2 weeks) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.||-0.51|-1.14|<0.001
71700104|NCT02320396|142915919|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.82|||<|0.001|TWO_SIDED|95.0|-1.14|-0.5|||cLDA model|||"Change from BL in TNSS at Week 1: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in TNSS was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.50|-1.14|<0.001
71700105|NCT02320396|142915919|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.84|||<|0.001|TWO_SIDED|95.0|-1.23|-0.46|||cLDA model|||"Change from BL in TNSS at Week 2: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.46|-1.23|<0.001
71700106|NCT02320396|142915920|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL to Week 1 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
71700107|NCT02320396|142915920|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.21|||<|0.001|TWO_SIDED|95.0|-0.32|-0.1|||cLDA model|||"Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.10|-0.32|<0.001
71700108|NCT02320396|142915920|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.008|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.008
71700109|NCT02320396|142915920|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.27|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.38|<0.001
71700110|NCT02320396|142915921|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.36|-0.13|||cLDA model|||"Change from BL to Week 2 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.13|-0.36|<0.001
71700111|NCT02320396|142915921|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
71700112|NCT02320396|142915921|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.037|TWO_SIDED|95.0|-0.18|-0.01|||cLDA model|||"Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.01|-0.18|0.037
71700113|NCT02320396|142915921|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.4|-0.12|||cLDA model|||"Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.40|<0.001
71700114|NCT02320396|142915922|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Sneezing During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
71700115|NCT02320396|142915922|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.23|||<|0.001|TWO_SIDED|95.0|-0.33|-0.12|||cLDA model|||"Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.33|<0.001
71700116|NCT02320396|142915922|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.09||||0.009|TWO_SIDED|95.0|-0.16|-0.02|||cLDA model|||"Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.02|-0.16|0.009
71700117|NCT02320396|142915922|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.26|||<|0.001|TWO_SIDED|95.0|-0.38|-0.15|||cLDA model|||"Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.~cLDA model"||-0.15|-0.38|<0.001
71700118|NCT02320396|142915923|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
71700119|NCT02320396|142915923|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.08|||cLDA model|||"Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.08|-0.24|<0.001
71700120|NCT02320396|142915923|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.15|-0.35|<0.001
71700121|NCT02320396|142915924|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
71700122|NCT02320396|142915924|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.13||||0.01|TWO_SIDED|95.0|-0.24|-0.03|||cLDA model|||"Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.03|-0.24|0.010
71700123|NCT02320396|142915924|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.24|||<|0.001|TWO_SIDED|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.12|-0.37|<0.001
71700124|NCT02320396|142915925|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Eye Pruritus During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.14|-0.35|<0.001
71700125|NCT02320396|142915925|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.15|||<|0.001|TWO_SIDED|95.0|-0.23|-0.07|||cLDA model|||"Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.23|<0.001
71700126|NCT02320396|142915925|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.25|||<|0.001|TWO_SIDED|95.0|-0.35|-0.15|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value||-0.15|-0.35|<0.001
71700127|NCT02320396|142915926|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.16|||<|0.001|TWO_SIDED|95.0|-0.24|-0.07|||cLDA model|||"Change from BL to Week 1 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.07|-0.24|<0.001
71700128|NCT02320396|142915926|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.19|||<|0.001|TWO_SIDED|95.0|-0.3|-0.09|||cLDA model|||"Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."||-0.09|-0.30|<0.001
71700129|NCT02320396|142915926|SUPERIORITY_OR_OTHER_LEGACY||Difference in LS Means|-0.17|||<|0.001|TWO_SIDED|95.0|-0.26|-0.08|||cLDA model|||"Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value."||-0.08|-0.26|<0.001
71700130|NCT02320396|142915927|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|1.492||||0.071|TWO_SIDED|95.0|0.966|2.303|||Regression, Logistic|||"Impression Rate as Assessed by Investigator: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo."||2.303|0.966|0.071
71700131|NCT02320396|142915928|SUPERIORITY_OR_OTHER_LEGACY||Odds Ratio (OR)|2.149|||<|0.001|TWO_SIDED|95.0|1.408|3.28|||Regression, Logistic|||"Impression Rate as Assessed by Participant: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of Better + Much better) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of \>1 indicated that desloratadine 5mg was more effective than placebo"||3.280|1.408|<0.001
71700132|NCT03331562|142915929|SUPERIORITY||Risk Ratio (RR)|0.0||||0.31|ONE_SIDED|95.0|0.0||||Fisher Exact||Lower bound cannot be estimated because there were 0 events in the comparison group.||||0|.31
71700133|NCT01138735|142915963|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics||"null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%"||||<0.001
71700134|NCT01138735|142915964|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed 'positive' if all primary analyses are shown statistically significant at the 0.05 level.|ANCOVA|normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.||null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)||||<0.001
71700135|NCT01138735|142915965|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||Cochran-Mantel-Haenszel|CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center||||||<0.001
71700136|NCT01138735|142915966|SUPERIORITY_OR_OTHER_LEGACY||||||<|0.001||95.0|||||ANCOVA|Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment||||||<0.001
71700137|NCT01719653|142916034|OTHER||||||<|0.005||||||Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.005
71700138|NCT01719653|142916035|OTHER||||||<|0.001||||||1 was lower than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"||||<0.001
71700139|NCT01719653|142916036|OTHER||||||>|0.005|||||||Chi-squared|||All 5 arms were compared pair-wise.||||>0.005
71700140|NCT01192178|142916044|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.971||||0.928|TWO_SIDED|95.0|0.519|1.819||Cox Proportional Hazards model adjusted for investigative center|Regression, Cox||The risk of having an asthma exacerbation during the treatment period was analyzed.|||1.819|0.519|0.928
71700141|NCT01155570|142916066|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71700142|NCT01155570|142916067|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 8||||<0.0001
71700143|NCT01155570|142916068|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71700144|NCT01155570|142916069|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71700145|NCT01155570|142916070|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71700146|NCT01155570|142916071|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71700147|NCT01155570|142916076|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71700148|NCT01155570|142916077|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71700149|NCT01155570|142916078|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71700150|NCT01155570|142916079|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71700151|NCT01155570|142916081|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71700152|NCT01155570|142916082|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71700153|NCT01155570|142916083|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71700154|NCT01155570|142916084|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71700155|NCT01155570|142916085|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 4||||<0.0001
71700156|NCT01155570|142916086|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 16||||<0.0001
71700157|NCT01155570|142916087|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||t-test, 2 sided|||comparison versus Baseline at Week 24||||<0.0001
71700158|NCT00296517|142916088|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Net)|0.2||||0.805||95.0|-1.6|2.0|||ANOVA|||Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.||2.0|-1.6|0.805
71700159|NCT00296517|142916098|SUPERIORITY_OR_OTHER_LEGACY|||||||0.036|||||||Log Rank|||||||0.036
71700160|NCT03513952|142916106|SUPERIORITY|||||||0.428||||||A one-sided significance level of 0.10 will be considered for the test.|Cochran-Mantel-Haenszel||||Estimations were done separately in each treatment arm; the difference between treatments was not calculated.|||0.428
71700161|NCT03513952|142916107|EQUIVALENCE|"Two-sided Cochran-Mantel-Haenszel test for the CBR was performed, which is used for testing zero effect or equivalence between treatments. A two-sided significance level of 0.05 will be considered for the test."|Risk Difference (RD)|-6.0||||0.702|TWO_SIDED|95.0|-36.3|24.3|||Cochran-Mantel-Haenszel|||||24.3|-36.3|0.702
71700162|NCT01143324|142916119|SUPERIORITY_OR_OTHER||Mean|1.3|STANDARD_DEVIATION|0.5|||TWO_SIDED|95.0|1.2|1.3||||||||1.3|1.2|
71700163|NCT01143324|142916120|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.3|||<|0.0001|TWO_SIDED|95.0|-3.6|-2.9|||t-test, 2 sided|||||-2.9|-3.6|<0.0001
71700164|NCT01143324|142916121|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.2|-3.3|||t-test, 2 sided|||||-3.3|-4.2|<0.0001
71700165|NCT01143324|142916122|SUPERIORITY_OR_OTHER||Difference from pre-op mean|0.35|||<|0.0001|TWO_SIDED|95.0|0.3|0.41|||t-test, 2 sided|||||0.41|0.30|<0.0001
71700166|NCT01143324|142916124|SUPERIORITY_OR_OTHER||Percentage|27.0|||||||||||||61/226 patients underwent a rehabilitation programs between 6 and 12 months follow up visit, making it 27.0 % of the total.|||||
71700167|NCT01143324|142916125|SUPERIORITY_OR_OTHER||Percentage|1.2|||||||||||||The rate of additional lumbar spinal surgeries at treated level was 1.2% (3/252) patients.|||||
71700168|NCT01143324|142916126|SUPERIORITY_OR_OTHER||Percentage|1.6|||||||||||||The rate of additional lumbar spinal surgeries at the same level was 1.6% (4/252) patients.|||||
71700169|NCT01143324|142916127|SUPERIORITY_OR_OTHER||Percentage at 12 months|47.6||||||||||||||||||
71700170|NCT01143324|142916129|SUPERIORITY_OR_OTHER||Difference from pre-op mean|-23.0|||<|0.0001|TWO_SIDED|95.0|-25.5|-20.5|||t-test, 2 sided|||||-20.5|-25.5|<0.0001
71700171|NCT01143324|142916130|SUPERIORITY_OR_OTHER||Percentage|42.7||||||||||||||||||
71700172|NCT01143324|142916131|SUPERIORITY_OR_OTHER||Mean|3.2|STANDARD_DEVIATION|2.0||||95.0|2.9|3.4||||||||3.4|2.9|
71700173|NCT01101178|142916147|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|110.0|||||TWO_SIDED|90.0|105.21|114.47|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||114.47|105.21|
71700174|NCT01101178|142916148|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.7|||||TWO_SIDED|90.0|92.71|96.64|||ANOVA||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.|||96.64|92.71|
71700175|NCT01101178|142916149|NON_INFERIORITY_OR_EQUIVALENCE|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.9|||||TWO_SIDED|90.0|92.9|97.02|||ANOVA||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.|||97.02|92.90|
71700176|NCT02696798|142916212|SUPERIORITY||Odds Ratio (OR)|2.41||||0.017|TWO_SIDED|95.0|1.17|4.95|||Regression, Logistic|||||4.95|1.17|0.017
71700177|NCT02696798|142916212|SUPERIORITY||Odds Ratio (OR)|3.06||||0.003|TWO_SIDED|95.0|1.48|6.33|||Regression, Logistic|||||6.33|1.48|0.003
71700178|NCT02696798|142916213|SUPERIORITY||Odds Ratio (OR)|2.2||||0.006|TWO_SIDED|95.0|1.26|3.84|||Regression, Logistic|||||3.84|1.26|0.006
71700179|NCT02696798|142916213|SUPERIORITY||Odds Ratio (OR)|2.08||||0.013|TWO_SIDED|95.0|1.16|3.73|||Regression, Logistic|||||3.73|1.16|0.013
71700180|NCT02696798|142916214|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.135|<|0.001|TWO_SIDED|95.0|-1.32|-0.79|||Mixed Models Analysis|||||-0.79|-1.32|<0.001
71700181|NCT02696798|142916214|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.14|<|0.001|TWO_SIDED|95.0|-1.3|-0.75|||Mixed Models Analysis|||||-0.75|-1.30|<0.001
71700182|NCT02696798|142916215|SUPERIORITY||Odds Ratio (OR)|2.65||||0.015|TWO_SIDED|95.0|1.21|5.84|||Regression, Logistic|||||5.84|1.21|0.015
71700183|NCT02696798|142916215|SUPERIORITY||Odds Ratio (OR)|2.9||||0.01|TWO_SIDED|95.0|1.29|6.49|||Regression, Logistic|||||6.49|1.29|0.010
71700184|NCT02696798|142916216|SUPERIORITY||LS Mean Difference (Final Values)|-1.24|STANDARD_ERROR_OF_MEAN|0.291|<|0.001|TWO_SIDED|95.0|-1.81|-0.67|||Mixed Models Analysis|||||-0.67|-1.81|<0.001
71700185|NCT02696798|142916216|SUPERIORITY||LS Mean Difference (Final Values)|-1.16|STANDARD_ERROR_OF_MEAN|0.301|<|0.001|TWO_SIDED|95.0|-1.76|-0.57|||Mixed Models Analysis|||||-0.57|-1.76|<0.001
71700186|NCT02696798|142916217|SUPERIORITY||LS Mean Difference (Final Values)|-1.05|STANDARD_ERROR_OF_MEAN|0.295|<|0.001|TWO_SIDED|95.0|-1.63|-0.47|||Mixed Models Analysis|||||-0.47|-1.63|<0.001
71700187|NCT02696798|142916217|SUPERIORITY||LS Mean Difference (Final Values)|-1.28|STANDARD_ERROR_OF_MEAN|0.307|<|0.001|TWO_SIDED|95.0|-1.89|-0.68|||Mixed Models Analysis|||||-0.68|-1.89|<0.001
71700188|NCT02696798|142916218|SUPERIORITY||Odds Ratio (OR)|3.73||||0.242|TWO_SIDED|95.0|0.41|33.98|||Regression, Logistic|||||33.98|0.41|0.242
71700189|NCT02696798|142916218|SUPERIORITY||Odds Ratio (OR)|5.42||||0.127|TWO_SIDED|95.0|0.62|47.54|||Regression, Logistic|||||47.54|0.62|0.127
71700190|NCT02696798|142916219|SUPERIORITY||Odds Ratio (OR)|4.22||||0.006|TWO_SIDED|95.0|1.5|11.86|||Regression, Logistic|||||11.86|1.50|0.006
71700191|NCT02696798|142916219|SUPERIORITY||Odds Ratio (OR)|4.52||||0.006|TWO_SIDED|95.0|1.55|13.18|||Regression, Logistic|||||13.18|1.55|0.006
71700192|NCT02696798|142916220|SUPERIORITY||LS Mean Difference (Final Values)|0.7689|STANDARD_ERROR_OF_MEAN|1.2863||0.55|TWO_SIDED|95.0|-1.7629|3.3007|||Mixed Models Analysis|||MCS||3.3007|-1.7629|0.550
71700193|NCT02696798|142916220|SUPERIORITY||LS Mean Difference (Final Values)|0.9104|STANDARD_ERROR_OF_MEAN|1.3338||0.495|TWO_SIDED|95.0|-1.7151|3.536|||Mixed Models Analysis|||MCS||3.5360|-1.7151|0.495
71700194|NCT02696798|142916220|SUPERIORITY||LS Mean Difference (Final Values)|5.2147|STANDARD_ERROR_OF_MEAN|1.1149|<|0.001|TWO_SIDED|95.0|3.0204|7.409|||Mixed Models Analysis|||PCS||7.4090|3.0204|<0.001
71700195|NCT02696798|142916220|SUPERIORITY||LS Mean Difference (Final Values)|4.7585|STANDARD_ERROR_OF_MEAN|1.1505|<|0.001|TWO_SIDED|95.0|2.494|7.023|||Mixed Models Analysis|||PCS||7.0230|2.4940|<0.001
71700196|NCT02696798|142916221|SUPERIORITY||LS Mean Difference (Final Values)|-1.03|STANDARD_ERROR_OF_MEAN|0.46||0.026|TWO_SIDED|95.0|-1.94|-0.13|||Mixed Models Analysis|||||-0.13|-1.94|0.026
71700197|NCT02696798|142916221|SUPERIORITY||LS Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.477||0.149|TWO_SIDED|95.0|-1.63|0.25|||Mixed Models Analysis|||||0.25|-1.63|0.149
71700198|NCT02696798|142916222|SUPERIORITY||LS Mean Difference (Final Values)|-1.95|STANDARD_ERROR_OF_MEAN|0.512|<|0.001|TWO_SIDED|95.0|-3.0|-0.9|||ANCOVA|||||-0.9|-3.0|<0.001
71700199|NCT02696798|142916222|SUPERIORITY||LS Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|0.534|<|0.001|TWO_SIDED|95.0|-3.2|-1.1|||ANCOVA|||||-1.1|-3.2|<0.001
71700200|NCT02696798|142916223|SUPERIORITY||LS Mean Difference (Final Values)|-6.29|STANDARD_ERROR_OF_MEAN|1.896||0.001|TWO_SIDED|95.0|-10.0|-2.5|||ANCOVA|||||-2.5|-10.0|0.001
71700201|NCT02696798|142916223|SUPERIORITY||LS Mean Difference (Final Values)|-7.27|STANDARD_ERROR_OF_MEAN|1.978|<|0.001|TWO_SIDED|95.0|-11.2|-3.4|||ANCOVA|||||-3.4|-11.2|<0.001
71700202|NCT02696798|142916224|SUPERIORITY||LS Mean Difference (Final Values)|-20.816|STANDARD_ERROR_OF_MEAN|3.7463|<|0.001|TWO_SIDED|95.0|-28.187|-13.444|||Mixed Models Analysis|||||-13.444|-28.187|<0.001
71700203|NCT02696798|142916224|SUPERIORITY||LS Mean Difference (Final Values)|-17.841|STANDARD_ERROR_OF_MEAN|3.9018|<|0.001|TWO_SIDED|95.0|-25.518|-10.163|||Mixed Models Analysis|||||-10.163|-25.518|<0.001
71700204|NCT02696798|142916225|SUPERIORITY||LS Mean Difference (Final Values)|-0.304|STANDARD_ERROR_OF_MEAN|0.1275||0.018|TWO_SIDED|95.0|-0.555|-0.053|||Mixed Models Analysis|||||-0.053|-0.555|0.018
71700205|NCT02696798|142916225|SUPERIORITY||LS Mean Difference (Final Values)|-0.172|STANDARD_ERROR_OF_MEAN|0.1319||0.194|TWO_SIDED|95.0|-0.431|0.088|||Mixed Models Analysis|||||0.088|-0.431|0.194
71700206|NCT02696798|142916226|SUPERIORITY||LS Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|0.893||0.17|TWO_SIDED|95.0|-0.53|2.99|||Mixed Models Analysis|||||2.99|-0.53|0.170
71700207|NCT02696798|142916226|SUPERIORITY||LS Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.916||0.8|TWO_SIDED|95.0|-1.57|2.04|||Mixed Models Analysis|||||2.04|-1.57|0.800
71700208|NCT02696798|142916227|SUPERIORITY||LS Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.521||0.547|TWO_SIDED|95.0|-1.34|0.71|||Mixed Models Analysis|||||0.71|-1.34|0.547
71700209|NCT02696798|142916227|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.538||0.064|TWO_SIDED|95.0|-2.06|0.06|||Mixed Models Analysis|||||0.06|-2.06|0.064
71700210|NCT02696798|142916228|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.58||0.861|TWO_SIDED|95.0|-1.0|1.3|||Mixed Models Analysis|||||1.3|-1.0|0.861
71700211|NCT02696798|142916228|SUPERIORITY||LS Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.59||0.626|TWO_SIDED|95.0|-1.4|0.9|||Mixed Models Analysis|||||0.9|-1.4|0.626
71700212|NCT02696798|142916229|SUPERIORITY||LS Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.59||0.504|TWO_SIDED|95.0|-1.6|0.8|||Mixed Models Analysis|||||0.8|-1.6|0.504
71700213|NCT02696798|142916229|SUPERIORITY||LS Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|0.62||0.86|TWO_SIDED|95.0|-1.1|1.3|||Mixed Models Analysis|||||1.3|-1.1|0.860
71700214|NCT02696798|142916230|SUPERIORITY||LS Mean Difference (Final Values)|-0.9|STANDARD_ERROR_OF_MEAN|1.03||0.362|TWO_SIDED|95.0|-3.0|1.1|||Mixed Models Analysis|||||1.1|-3.0|0.362
71700215|NCT02696798|142916230|SUPERIORITY||LS Mean Difference (Final Values)|-1.1|STANDARD_ERROR_OF_MEAN|1.08||0.303|TWO_SIDED|95.0|-3.3|1.0|||Mixed Models Analysis|||||1.0|-3.3|0.303
71700216|NCT02696798|142916231|SUPERIORITY||LS Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.7||0.813|TWO_SIDED|95.0|-1.5|1.2|||Mixed Models Analysis|||||1.2|-1.5|0.813
71700217|NCT02696798|142916231|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.71||0.41|TWO_SIDED|95.0|-2.0|0.8|||Mixed Models Analysis|||||0.8|-2.0|0.410
71700218|NCT02696798|142916233|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.33|<|0.001|TWO_SIDED|95.0|-1.9|-0.6|||Mixed Models Analysis|||||-0.6|-1.9|<0.001
71700219|NCT02696798|142916233|SUPERIORITY||LS Mean Difference (Final Values)|-1.0|STANDARD_ERROR_OF_MEAN|0.34||0.005|TWO_SIDED|95.0|-1.6|-0.3|||Mixed Models Analysis|||||-0.3|-1.6|0.005
71700220|NCT02696798|142916234|SUPERIORITY||LS Mean Difference (Final Values)|-1.2|STANDARD_ERROR_OF_MEAN|0.68||0.088|TWO_SIDED|95.0|-2.5|0.2|||Mixed Models Analysis|||||0.2|-2.5|0.088
71700221|NCT02696798|142916234|SUPERIORITY||LS Mean Difference (Final Values)|-0.6|STANDARD_ERROR_OF_MEAN|0.7||0.366|TWO_SIDED|95.0|-2.0|0.7|||Mixed Models Analysis|||||0.7|-2.0|0.366
71700222|NCT02696798|142916235|SUPERIORITY||LS Mean Difference (Final Values)|-11.13|STANDARD_ERROR_OF_MEAN|5.323||0.038|TWO_SIDED|95.0|-21.65|-0.6|||ANCOVA|||Overall Work Impairment Score||-0.60|-21.65|0.038
71700223|NCT02696798|142916235|SUPERIORITY||LS Mean Difference (Final Values)|-13.66|STANDARD_ERROR_OF_MEAN|5.341||0.012|TWO_SIDED|95.0|-24.23|-3.1|||ANCOVA|||Overall Work Impairment Score||-3.10|-24.23|0.012
71700224|NCT02696798|142916235|SUPERIORITY||LS Mean Difference (Final Values)|-6.3|STANDARD_ERROR_OF_MEAN|3.5||0.071|TWO_SIDED|95.0|-13.2|0.5|||ANCOVA|||Percentage of Activity Impairment||0.5|-13.2|0.071
71700225|NCT02696798|142916235|SUPERIORITY||LS Mean Difference (Final Values)|-8.3|STANDARD_ERROR_OF_MEAN|3.65||0.024|TWO_SIDED|95.0|-15.5|-1.1|||ANCOVA|||Percentage of Activity Impairment||-1.1|-15.5|0.024
71758613|NCT00836693|143019589|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.3|STANDARD_ERROR_OF_MEAN|0.3|<|0.001|TWO_SIDED|95.0|0.7|1.9||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.||1.9|0.7|<0.001
71758614|NCT00836693|143019590|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.3|STANDARD_ERROR_OF_MEAN|2.22||0.0047|TWO_SIDED|95.0|2.0|10.7||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||10.7|2.0|0.0047
71758615|NCT00836693|143019591|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|24.5|STANDARD_ERROR_OF_MEAN|4.99|<|0.001|TWO_SIDED|95.0|14.6|34.3||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||34.3|14.6|<0.001
71758616|NCT00836693|143019592|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|23.5|STANDARD_ERROR_OF_MEAN|4.96|<|0.001|TWO_SIDED|95.0|13.7|33.2||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.||33.2|13.7|<0.001
71758617|NCT00836693|143019593|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
71758618|NCT00836693|143019594|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0||||p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.||||<0.0001
71758619|NCT01750229|143019600|SUPERIORITY|||||||0.002|||||||Mixed Models Analysis|Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.||||||0.002
71758620|NCT03408392|143019648|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.38|||||TWO_SIDED|90.0|96.11|115.54||||||||115.54|96.11|
71758621|NCT03408392|143019649|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|101.14|||||TWO_SIDED|90.0|93.37|109.55||||||||109.55|93.37|
71758622|NCT03408392|143019650|EQUIVALENCE|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.14|||||TWO_SIDED|90.0|96.31|114.78||||||||114.78|96.31|
71758623|NCT00885170|143019672|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.67|||<|0.001|TWO_SIDED|95.0|1.17|4.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value \< 0.001).||4.17|1.17|<0.001
71758624|NCT00885170|143019673|SUPERIORITY_OR_OTHER||Difference in Percentages vs. Placebo|-5.5|||||TWO_SIDED|95.0|-16.9|6.0|||||Based on Miettinen \& Nurminen method.|||6.0|-16.9|
71758625|NCT00885170|143019674|SUPERIORITY_OR_OTHER||Difference in the Percentage vs. Placebo|5.7|||||TWO_SIDED|95.0|-0.4|12.6|||||Based on Miettinen \& Nurminen method.|||12.6|-0.4|
71758626|NCT00885170|143019675|SUPERIORITY_OR_OTHER||Difference in the least Squares Means|0.88||||0.166|TWO_SIDED|95.0|-0.37|2.14|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.14|-0.37|0.166
71758627|NCT00885170|143019676|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|3.18||||0.002|TWO_SIDED|95.0|1.19|5.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||5.17|1.19|0.002
71758628|NCT00885170|143019677|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.0||||0.142|TWO_SIDED|95.0|-0.34|2.35|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||2.35|-0.34|0.142
71758629|NCT00885170|143019678|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.7|||<|0.001|TWO_SIDED|95.0|1.41|4.0|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||4.00|1.41|<0.001
71758630|NCT00885170|143019679|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.06||||0.023|TWO_SIDED|95.0|0.15|1.98|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.98|0.15|0.023
71758631|NCT00885170|143019680|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|2.57|||<|0.001|TWO_SIDED|95.0|1.26|3.89|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||3.89|1.26|<0.001
71758632|NCT00885170|143019681|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.8||||0.103|TWO_SIDED|95.0|-0.16|1.77|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.77|-0.16|0.103
71758633|NCT00885170|143019682|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.22||||0.763|TWO_SIDED|95.0|-1.23|1.67|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.67|-1.23|0.763
71758634|NCT00885170|143019683|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.38||||0.578|TWO_SIDED|95.0|-0.96|1.72|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, \>5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|||1.72|-0.96|0.578
71758635|NCT00885170|143019684|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.16||||0.5|TWO_SIDED|95.0|-19.39|39.72|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||39.72|-19.39|0.500
71758636|NCT00885170|143019685|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.82||||0.709|TWO_SIDED|95.0|-36.29|24.65|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||24.65|-36.29|0.709
71758637|NCT00885170|143019686|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-47.04|||<|0.001|TWO_SIDED|95.0|-62.4|-31.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.67|-62.40|<0.001
71758638|NCT00885170|143019687|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-46.29|||<|0.001|TWO_SIDED|95.0|-61.43|-31.15|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||-31.15|-61.43|<0.001
71758639|NCT00885170|143019688|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|10.96||||0.186|TWO_SIDED|95.0|-5.29|27.22|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||27.22|-5.29|0.186
71758640|NCT00885170|143019689|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|12.82||||0.015|TWO_SIDED|95.0|2.54|23.1|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||23.10|2.54|0.015
71758641|NCT00885170|143019690|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|31.17||||0.011|TWO_SIDED|95.0|7.13|55.21|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||55.21|7.13|0.011
71758642|NCT00885170|143019691|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|24.01||||0.059|TWO_SIDED|95.0|-0.93|48.94|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||48.94|-0.93|0.059
71758643|NCT00885170|143019692|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|0.11||||0.846|TWO_SIDED|95.0|-0.95|1.16|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||1.16|-0.95|0.846
71758644|NCT00885170|143019693|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.38||||0.413|TWO_SIDED|95.0|-1.91|4.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||4.67|-1.91|0.413
71758645|NCT00885170|143019694|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-5.91||||0.326|TWO_SIDED|95.0|-17.66|5.85|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||5.85|-17.66|0.326
71758646|NCT00885170|143019695|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|1.47||||0.835|TWO_SIDED|95.0|-12.37|15.32|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||15.32|-12.37|0.835
71758647|NCT00885170|143019696|SUPERIORITY_OR_OTHER||Difference in the Least Squares Means|-3.13||||0.376|TWO_SIDED|95.0|-10.04|3.78|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.|||3.78|-10.04|0.376
71758648|NCT03771664|143019697|SUPERIORITY||Least Square (LS) Mean Difference|3.2|STANDARD_ERROR_OF_MEAN|2.23||0.1537|TWO_SIDED|95.0|-1.2|7.7||Average change from baseline in SE was analyzed by analysis of covariance (ANCOVA) with explanatory (treatment, baseline antidepressant use, baseline SE) and response variables \[change from baseline in sleep efficiency at Day 14 (EODBT)\].|ANCOVA|||||7.7|-1.2|0.1537
71758649|NCT03771664|143019698|SUPERIORITY||LS Mean Difference|-13.0|STANDARD_ERROR_OF_MEAN|8.07||0.1126|TWO_SIDED|95.0|-29.0|3.1||Change from BL in overall WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from baseline (BL) in overall WASO||3.1|-29.0|0.1126
71758650|NCT03771664|143019698|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|1.63||0.9819|TWO_SIDED|95.0|-3.3|3.2||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 1||3.2|-3.3|0.9819
71758651|NCT03771664|143019698|SUPERIORITY||LS Mean Difference|-4.3|STANDARD_ERROR_OF_MEAN|3.19||0.1838|TWO_SIDED|95.0|-10.6|2.1||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 2||2.1|-10.6|0.1838
71758652|NCT03771664|143019698|SUPERIORITY||LS Mean Difference|-7.1|STANDARD_ERROR_OF_MEAN|3.97||0.0797|TWO_SIDED|95.0|-15.0|0.9||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 3||0.9|-15.0|0.0797
71758653|NCT03771664|143019698|SUPERIORITY||LS Mean Difference|-6.1|STANDARD_ERROR_OF_MEAN|4.24||0.1559|TWO_SIDED|95.0|-14.5|2.4||Change from BL in WASO was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, baseline PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in WASO in quarter 4||2.4|-14.5|0.1559
71758654|NCT03771664|143019699|SUPERIORITY||LS Mean Difference|15.8|STANDARD_ERROR_OF_MEAN|10.67||0.1441|TWO_SIDED|95.0|-5.5|37.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in overall TST||37.0|-5.5|0.1441
71758655|NCT03771664|143019699|SUPERIORITY||LS Mean Difference|4.7|STANDARD_ERROR_OF_MEAN|5.47||0.3951|TWO_SIDED|95.0|-6.2|15.6||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 1||15.6|-6.2|0.3951
71758656|NCT03771664|143019699|SUPERIORITY||LS Mean Difference|3.7|STANDARD_ERROR_OF_MEAN|4.16||0.3705|TWO_SIDED|95.0|-4.5|12.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BLPSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 2||12.0|-4.5|0.3705
71758657|NCT03771664|143019699|SUPERIORITY||LS Mean Difference|6.0|STANDARD_ERROR_OF_MEAN|4.04||0.1412|TWO_SIDED|95.0|-2.0|14.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 3||14.0|-2.0|0.1412
71758658|NCT03771664|143019699|SUPERIORITY||LS Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|4.24||0.1298|TWO_SIDED|95.0|-2.0|15.0||Change from BL in TST was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in TST in quarter 4||15.0|-2.0|0.1298
71758659|NCT03771664|143019700|SUPERIORITY||LS Mean Difference|-2.5|STANDARD_ERROR_OF_MEAN|7.87||0.7526|TWO_SIDED|95.0|-18.2|13.2||Change from BL in LPS was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||13.2|-18.2|0.7526
71758660|NCT03771664|143019701|SUPERIORITY||LS Mean Difference|-0.3|STANDARD_ERROR_OF_MEAN|0.83||0.6769|TWO_SIDED|95.0|-2.0|1.3||Change from BL in NAW was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||||1.3|-2.0|0.6769
71758661|NCT03771664|143019702|SUPERIORITY||LS Mean Difference|-3.0|STANDARD_ERROR_OF_MEAN|1.7||0.0824|TWO_SIDED|95.0|-6.4|0.4||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in mean duration of awakenings (MDA) in total||0.4|-6.4|0.0824
71758662|NCT03771664|143019702|SUPERIORITY||LS Mean Difference|-0.9|STANDARD_ERROR_OF_MEAN|1.07||0.4269|TWO_SIDED|95.0|-3.0|1.3||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 1||1.3|-3.0|0.4269
71758663|NCT03771664|143019702|SUPERIORITY|Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|LS Mean Difference|-3.5|STANDARD_ERROR_OF_MEAN|3.02||0.2482|TWO_SIDED|95.0|-9.5|2.5|||ANCOVA|||Change from BL in MDA in quarter 2||2.5|-9.5|0.2482
71758664|NCT03771664|143019702|SUPERIORITY||LS Mean Difference|-3.4|STANDARD_ERROR_OF_MEAN|3.34||0.3076|TWO_SIDED|95.0|-10.1|3.2||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 3||3.2|-10.1|0.3076
71758665|NCT03771664|143019702|SUPERIORITY||LS Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.68||0.4491|TWO_SIDED|95.0|-1.9|0.8||Change from BL in MDA was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in MDA in quarter 4||0.8|-1.9|0.4491
71758666|NCT03771664|143019703|SUPERIORITY||LS Mean Difference|0.4|STANDARD_ERROR_OF_MEAN|2.47||0.8724|TWO_SIDED|95.0|-4.5|5.3||Change from BL in DS N1 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in duration of stage (DS) N1 sleep||5.3|-4.5|0.8724
71758667|NCT03771664|143019703|SUPERIORITY||LS Mean Difference|18.6|STANDARD_ERROR_OF_MEAN|8.08||0.0238|TWO_SIDED|95.0|2.5|34.7||Change from BL in DS N2 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N2 sleep||34.7|2.5|0.0238
71758668|NCT03771664|143019703|SUPERIORITY||LS Mean Difference|4.9|STANDARD_ERROR_OF_MEAN|5.62||0.3863|TWO_SIDED|95.0|-6.3|16.1||Change from BL in DS N3 sleep was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in DS N3 sleep||16.1|-6.3|0.3863
71758669|NCT03771664|143019703|SUPERIORITY||LS Mean Difference|-10.2|STANDARD_ERROR_OF_MEAN|4.69||0.032|TWO_SIDED|95.0|-19.6|-0.9||Change from BL in REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14(EODBT)\].|ANCOVA|||Change from BL in duration of REM sleep||-0.9|-19.6|0.0320
71758670|NCT03771664|143019704|SUPERIORITY||LS Mean Difference|0.0|STANDARD_ERROR_OF_MEAN|0.8||0.9524|TWO_SIDED|95.0|-1.7|1.6||Change from BL in PS N1 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score;Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in percentage of stage (PS) N1 sleep time||1.6|-1.7|0.9524
71758671|NCT03771664|143019704|SUPERIORITY||LS Mean Difference|2.6|STANDARD_ERROR_OF_MEAN|1.55||0.093|TWO_SIDED|95.0|-0.5|5.7||Change from BL in PS N2 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N2 sleep time||5.7|-0.5|0.0930
71758672|NCT03771664|143019704|SUPERIORITY||LS Mean Difference|1.2|STANDARD_ERROR_OF_MEAN|1.52||0.4427|TWO_SIDED|95.0|-1.9|4.2||Change from BL in PS N3 sleep time was analyzed by ANCOVA with explanatory variables: Treatment, BL antidepressant use, BL PSG-derived sleep variables score; Response variable: Change from BL in PSG-derived sleep variables at Day 14 (EODBT).|ANCOVA|||Change from BL in PS N3 sleep time||4.2|-1.9|0.4427
71758673|NCT03771664|143019704|SUPERIORITY||LS Mean Difference|-3.8|STANDARD_ERROR_OF_MEAN|1.06||0.0006|TWO_SIDED|95.0|-5.9|-1.7||Change from BL in % of REM sleep duration was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in percentage (%) of REM sleep time||-1.7|-5.9|0.0006
71758674|NCT03771664|143019705|SUPERIORITY||LS Mean Difference|33.7|STANDARD_ERROR_OF_MEAN|12.42||0.0083|TWO_SIDED|95.0|8.9|58.4||Change from BL in latency to first REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the first REM period||58.4|8.9|0.0083
71758675|NCT03771664|143019705|SUPERIORITY||LS Mean Difference|43.2|STANDARD_ERROR_OF_MEAN|10.95||0.0002|TWO_SIDED|95.0|21.3|65.0||Change from BL in latency to second REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the second REM period||65.0|21.3|0.0002
71758676|NCT03771664|143019705|SUPERIORITY||LS Mean Difference|38.2|STANDARD_ERROR_OF_MEAN|10.99||0.0009|TWO_SIDED|95.0|16.2|60.2||Change from BL in latency to third REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the third REM period||60.2|16.2|0.0009
71758677|NCT03771664|143019705|SUPERIORITY||LS Mean Difference|26.0|STANDARD_ERROR_OF_MEAN|14.84||0.0899|TWO_SIDED|95.0|-4.3|56.3||Change from BL in latency to fourth REM period was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||Change from BL in latency to the fourth REM period||56.3|-4.3|0.0899
71758678|NCT03771664|143019706|SUPERIORITY||LS Mean Difference|-171.1|STANDARD_ERROR_OF_MEAN|46.06||0.0004|TWO_SIDED|95.0|-262.9|-79.4||Change from BL in REM density was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, BL PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-79.4|-262.9|0.0004
71758679|NCT03771664|143019707|SUPERIORITY||LS Mean Difference|-288.0|STANDARD_ERROR_OF_MEAN|68.81|<|0.0001|TWO_SIDED|95.0|-425.1|-151.0||Change from BL in REMA was analyzed by ANCOVA with explanatory (Treatment, BL antidepressant use, baseline PSG-derived sleep variables score) and response variables \[Change from BL in PSG-derived sleep variables at Day 14 (EODBT)\].|ANCOVA|||||-151.0|-425.1|<0.0001
71758680|NCT03771664|143019709|SUPERIORITY||LS Mean Difference|10.4|STANDARD_ERROR_OF_MEAN|14.65||0.4814|TWO_SIDED|95.0|-18.8|39.5||Change from BL in sTST was analyzed by Mixed Model Repeated Measures (MMRM) with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sTST||39.5|-18.8|0.4814
71758681|NCT03771664|143019709|SUPERIORITY||LS Mean Difference|-10.9|STANDARD_ERROR_OF_MEAN|6.45||0.0964|TWO_SIDED|95.0|-23.7|2.0||Change from BL in sWASO was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sWASO||2.0|-23.7|0.0964
71758682|NCT03771664|143019709|SUPERIORITY||LS Mean Difference|6.6|STANDARD_ERROR_OF_MEAN|7.32||0.3672|TWO_SIDED|95.0|-7.9|21.2||Change from BL in sSL was analyzed by MMRM with treatment baseline antidepressant use, baseline CSD-C value, assessment time point, and time point-by-treatment interaction as fixed effects.|MMRM|||Change from BL in sSL||21.2|-7.9|0.3672
71758683|NCT00561925|143019721|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%|Cochran's statistic|4.9|||<|0.0001||95.0|-0.1|10.0|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.0|-0.1|<0.0001
71758684|NCT00561925|143019723|NON_INFERIORITY_OR_EQUIVALENCE|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%|Cochran's statistic|4.84|||<|0.0001||95.0|-1.11|10.79|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.|||10.79|-1.11|<0.0001
71758685|NCT00561925|143019725|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01||||0.7719||95.0|-0.08|0.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||0.06|-0.08|0.7719
71758686|NCT00561925|143019726|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.87||||0.0078||95.0|8.67|57.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum||||57.06|8.67|0.0078
71758687|NCT00561925|143019734|NON_INFERIORITY_OR_EQUIVALENCE|equivalence test with 80% -125% boundaries|adjusted gMean|79.58|STANDARD_ERROR_OF_MEAN|1.04||0.5542||90.0|74.62|84.86||p-value for ratio outside the interval 80%-125%|ANOVA||Inter-individual gCV = 49.9|adjusted geometric mean ratio NVP XR : NVP IR||84.86|74.62|0.5542
71758688|NCT03096288|143019751|SUPERIORITY||Mean Difference (Final Values)|22.0||||0.169|TWO_SIDED|95.0|-9.0|52.0|||t-test, 2 sided|||||52|-9|0.169
71758689|NCT03096288|143019751|SUPERIORITY||Median Difference (Final Values)|17.0||||0.236|TWO_SIDED|95.0|-11.0|45.0|||t-test, 2 sided|||||45|-11|0.236
71758690|NCT01411891|143019754|SUPERIORITY||Risk Ratio (RR)|1.5|||||TWO_SIDED|95.0|0.3|8.4||||||||8.4|0.3|
71758691|NCT01411891|143019755|SUPERIORITY||Risk Ratio (RR)|0.8||||0.65|TWO_SIDED|95.0|0.4|1.6|||Regression, Logistic|||||1.6|0.4|0.65
71758692|NCT02004093|143019757|SUPERIORITY_OR_OTHER|||||||0.3967|||||||Log Rank|||||||0.3967
71758693|NCT02004093|143019757|SUPERIORITY_OR_OTHER|||||||0.4552|||||||Wilcoxon (Mann-Whitney)|||||||0.4552
71758694|NCT02004093|143019757|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.17||||0.3972|TWO_SIDED|80.0|0.92|1.49||p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1|Wald test|||||1.49|0.92|0.3972
71758695|NCT02004093|143019758|SUPERIORITY_OR_OTHER||Difference in Response Rates|6.32||||0.3943|TWO_SIDED|80.0|-3.9|16.6|||Chi-squared|||||16.6|-3.9|0.3943
71758696|NCT02004093|143019758|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.36|||||TWO_SIDED|80.0|0.86|2.17|||||approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method|||2.17|0.86|
71758697|NCT02004093|143019759|SUPERIORITY_OR_OTHER|||||||0.3655|||||||Log Rank|||||||0.3655
71758698|NCT02004093|143019759|SUPERIORITY_OR_OTHER|||||||0.1319|||||||Wilcoxon (Mann-Whitney)|||||||0.1319
71758699|NCT02004093|143019759|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.22||||0.3679|TWO_SIDED|80.0|0.92|1.61|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.61|0.92|0.3679
71758700|NCT02004093|143019762|SUPERIORITY_OR_OTHER|||||||0.8129|||||||Log Rank|||||||0.8129
71758701|NCT02004093|143019762|SUPERIORITY_OR_OTHER|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||||||0.6920
71758702|NCT02004093|143019762|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.8137|TWO_SIDED|80.0|0.82|1.32|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.32|0.82|0.8137
71758703|NCT02004093|143019765|SUPERIORITY_OR_OTHER|||||||0.5726|||||||Log Rank|||||||0.5726
71758704|NCT02004093|143019765|SUPERIORITY_OR_OTHER|||||||0.3903|||||||Wilcoxon (Mann-Whitney)|||||||0.3903
71758705|NCT02004093|143019765|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.11||||0.587|TWO_SIDED|80.0|0.87|1.43|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1||||1.43|0.87|0.5870
71758706|NCT02004093|143019767|SUPERIORITY_OR_OTHER|||||||0.9261|||||||Log Rank|||||||0.9261
71758707|NCT02004093|143019767|SUPERIORITY_OR_OTHER|||||||0.8591|||||||Wilcoxon (Mann-Whitney)|||||||0.8591
71758708|NCT02004093|143019767|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.02||||0.9262|TWO_SIDED|80.0|0.74|1.41||p-value resulting from Wald test of null hypothesis that the hazard ratio=1|Wald test|||||1.41|0.74|0.9262
71758709|NCT02504151|143019851|SUPERIORITY||Mean Difference (Net)|-0.284|STANDARD_ERROR_OF_MEAN|1.01||0.08|TWO_SIDED|95.0|-2.28|1.71|||Mixed Models Analysis|Linear mixed models was used with treatment, time and time\*treatment interaction in the model.|This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||1.71|-2.28|0.08
71758710|NCT02504151|143019852|SUPERIORITY||Mean Difference (Net)|-0.03|STANDARD_ERROR_OF_MEAN|0.05||0.48|TWO_SIDED|95.0|-0.12|0.07|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||0.07|-0.12|0.48
71758711|NCT02504151|143019853|SUPERIORITY||Mean Difference (Net)|-4.97|STANDARD_ERROR_OF_MEAN|2.47||0.485|TWO_SIDED|95.0|-9.87|-0.06|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||-0.06|-9.87|0.485
71758712|NCT02504151|143019854|SUPERIORITY||Mean Difference (Net)|4.13|STANDARD_ERROR_OF_MEAN|2.05||0.994|TWO_SIDED|95.0|0.07|8.19|||Mixed Models Analysis||This is the estimated difference between treatment groups (cbd - placebo).|The p value is based on the interaction of treatment and time.||8.19|0.07|0.994
71758713|NCT00472576|143019882|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.291|STANDARD_ERROR_OF_MEAN|0.693||0.001|TWO_SIDED|95.0|0.911|3.671|||Mixed Models Analysis||Mean differences reflect groups differences at end point.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||3.671|0.911|.001
71761218|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0805|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.||||0.0805
71758714|NCT00472576|143019883|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|2.479||0.272|TWO_SIDED|95.0|-6.981|2.901||This test is a comparison of the MK-0657 condition to the placebo condition.|Mixed Models Analysis||The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz's Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.||2.901|-6.981|.272
71758715|NCT02557139|143019888|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|< 0.001
71758716|NCT02557139|143019888|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Geometric Means (%)|100.0||||0.23|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||Cmax null hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 48.00%|125.00|80.00|0.23
71758717|NCT02557139|143019889|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability: 34.25%|125.00|80.00|<0.001
71758718|NCT02557139|143019889|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.16|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-inf) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability;|125.00|80.00|0.16
71758719|NCT02557139|143019889|EQUIVALENCE|If the 90% confidence interval for the comparison of fed vs. fasted is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect of food on belumosudil tablets.|Ratio of Adjusted Geometric Means (%)|100.0|||<|0.001|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided|||AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|< 0.001
71758720|NCT02557139|143019889|EQUIVALENCE|If the 90% confidence interval for the comparison of belumosudil tablet (test drug) vs. the belumosudil capsule (reference drug) is within the acceptance range 80.00% to 125.00%, then it is concluded that there is no effect on the use of belumosudi tablet compared to belumosudil capsule.|Ratio of Adjusted Geometric Means (%)|100.0||||0.18|TWO_SIDED|90.0|80.0|125.0|||t-test, 2 sided||Intra-subject variability = 38.16%|AUC(0-last) Null Hypothesis: Ratio of Adjusted Geometric Means = 100%|Intra-subject variability = 38.16%|125.00|80.00|0.18
71758721|NCT02148874|143019915|SUPERIORITY||Odds Ratio (OR)|1.05||||0.84|TWO_SIDED|95.0|0.64|1.73|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1.||1.73|0.64|0.84
71758722|NCT02148874|143019915|SUPERIORITY||Odds Ratio (OR)|1.07||||0.79|TWO_SIDED|95.0|0.65|1.75|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.75|0.65|0.79
71758723|NCT02148874|143019915|SUPERIORITY||Odds Ratio (OR)|1.26||||0.43|TWO_SIDED|95.0|0.71|2.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Massachusetts||2.24|0.71|0.43
71758724|NCT02148874|143019915|SUPERIORITY||Odds Ratio (OR)|1.08||||0.77|TWO_SIDED|95.0|0.63|1.87|||Regression, Logistic||Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Brisbane||1.87|0.63|0.77
71758725|NCT02148874|143019916|SUPERIORITY||Odds Ratio (OR)|1.39||||0.2|TWO_SIDED|95.0|0.84|2.32|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||2.32|0.84|0.20
71758726|NCT02148874|143019916|SUPERIORITY||Odds Ratio (OR)|1.09||||0.74|TWO_SIDED|95.0|0.66|1.8|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.80|0.66|0.74
71758727|NCT02148874|143019916|SUPERIORITY||Odds Ratio (OR)|1.89||||0.04|TWO_SIDED|95.0|1.04|3.44|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||3.44|1.04|0.04
71758728|NCT02148874|143019916|SUPERIORITY||Odds Ratio (OR)|1.63||||0.13|TWO_SIDED|95.0|0.87|3.04|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||3.04|0.87|0.13
71758729|NCT02148874|143019917|SUPERIORITY||Odds Ratio (OR)|0.89||||0.64|TWO_SIDED|95.0|0.53|1.48|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1||1.48|0.53|0.64
71758730|NCT02148874|143019917|SUPERIORITY||Odds Ratio (OR)|0.89||||0.67|TWO_SIDED|95.0|0.53|1.5|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2||1.50|0.53|0.67
71758731|NCT02148874|143019917|SUPERIORITY||Odds Ratio (OR)|1.47||||0.14|TWO_SIDED|95.0|0.88|2.46|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts||2.46|0.88|0.14
71758732|NCT02148874|143019917|SUPERIORITY||Odds Ratio (OR)|0.74||||0.25|TWO_SIDED|95.0|0.44|1.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane||1.24|0.44|0.25
71758733|NCT02592798|143019918|SUPERIORITY||Mean Difference (Final Values)|-7.7|||||TWO_SIDED|95.0|-46.8|33.3|||||Abatacept - Placebo for Double-Blind Period Day 113|||33.3|-46.8|
71758734|NCT02592798|143019918|SUPERIORITY||Mean Difference (Final Values)|-20.8|||||TWO_SIDED|95.0|-63.3|24.3|||||Abatacept - Placebo for Open Label Period Day 113|||24.3|-63.3|
71758735|NCT02592798|143019919|SUPERIORITY||Mean Difference (Final Values)|0.37|||||TWO_SIDED|95.0|-1.6495|2.3855|||||Abatacept - Placebo for Double-Blind Period Day 113|||2.3855|-1.6495|
71758736|NCT02592798|143019919|SUPERIORITY||Mean Difference (Final Values)|1.95|||||TWO_SIDED|95.0|-1.7933|5.6954|||||Abatacept - Placebo for Open Label Period Day 113|||5.6954|-1.7933|
71758737|NCT02592798|143019920|SUPERIORITY||Mean Difference (Final Values)|0.13|||||TWO_SIDED|95.0|-0.1483|0.4119|||||Abatacept - Placebo for Double-Blind Period Day 113|||0.4119|-0.1483|
71758738|NCT02592798|143019920|SUPERIORITY||Mean Difference (Final Values)|0.12|||||TWO_SIDED|95.0|-0.5107|0.7551|||||Abatacept - Placebo for Open Label Period Day 113|||0.7551|-0.5107|
71758739|NCT02592798|143019921|SUPERIORITY||Mean Difference (Final Values)|1.4|||||TWO_SIDED|95.0|-44.7|44.7|||||Abatacept - Placebo for Open Label Period Day 113|||44.7|-44.7|
71758740|NCT02592798|143019922|SUPERIORITY||Mean Difference (Final Values)|-0.69|||||TWO_SIDED|95.0|-8.1395|6.7645|||||Abatacept - Placebo for Fatigue|||6.7645|-8.1395|
71758741|NCT02592798|143019922|SUPERIORITY||Mean Difference (Final Values)|-3.7|||||TWO_SIDED|95.0|-13.9402|6.5402|||||Abatacept - Placebo for Pain interference|||6.5402|-13.9402|
71758742|NCT02592798|143019922|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-6.5736|4.5736|||||Abatacept - Placebo for Physical function|||4.5736|-6.5736|
71758743|NCT02592798|143019923|SUPERIORITY||Mean Difference (Final Values)|12.45|||||TWO_SIDED|95.0|-4.595|29.485|||||Abatacept - Placebo for Fatigue|||29.4850|-4.5950|
71758744|NCT02592798|143019923|SUPERIORITY||Mean Difference (Final Values)|7.14|||||TWO_SIDED|95.0|-2.5917|16.8717|||||Abatacept - Placebo for Pain interference|||16.8717|-2.5917|
71758745|NCT02592798|143019923|SUPERIORITY||Mean Difference (Final Values)|-0.88|||||TWO_SIDED|95.0|-12.1068|10.3468|||||Abatacept - Placebo for Mobility|||10.3468|-12.1068|
71758746|NCT00705016|143019932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.03||||0.885|TWO_SIDED|95.0|0.67|1.59||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log Hazard ratio (HR), if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||1.59|0.67|0.885
71758747|NCT00705016|143019932|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.55||||0.054|TWO_SIDED|95.0|0.99|2.43||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) \<80/\>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.||2.43|0.99|0.054
71758748|NCT00705016|143019933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.94||||0.8|TWO_SIDED|95.0|0.61|1.47||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.47|0.61|0.800
71758749|NCT00705016|143019933|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.04||||0.878|TWO_SIDED|95.0|0.66|1.63|||Cox proportional hazards model|||||1.63|0.66|0.878
71758750|NCT00705016|143019934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.595||||0.205|TWO_SIDED|95.0|0.776|3.276||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.276|0.776|0.205
71758751|NCT00705016|143019934|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.671||||0.317|TWO_SIDED|95.0|0.307|1.465||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.465|0.307|0.317
71758752|NCT00705016|143019935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.396||||0.476|TWO_SIDED|95.0|0.551|3.539||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||3.539|0.551|0.476
71758753|NCT00705016|143019935|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.668||||0.347|TWO_SIDED|95.0|0.287|1.555||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel|||||1.555|0.287|0.347
71758754|NCT00705016|143019936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.23||||0.294|TWO_SIDED|95.0|0.84|1.81||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||1.81|0.84|0.294
71758755|NCT00705016|143019936|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.73||||0.007|TWO_SIDED|95.0|1.16|2.57||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.57|1.16|0.007
71758756|NCT00705016|143019937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.3||||0.391|TWO_SIDED|95.0|0.71|2.39||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||2.39|0.71|0.391
71758757|NCT00705016|143019937|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|2.6||||0.007|TWO_SIDED|95.0|1.3|5.21||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model|||||5.21|1.30|0.007
71758758|NCT02233517|143019939|SUPERIORITY||Mean Difference (Net)|-0.1|STANDARD_ERROR_OF_MEAN|0.51||0.84|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.84
71758759|NCT02233517|143019939|SUPERIORITY||Slope|0.23|STANDARD_ERROR_OF_MEAN|0.52|<|0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||<0.44
71758760|NCT02233517|143019939|SUPERIORITY||Slope|0.5|STANDARD_ERROR_OF_MEAN|0.51||0.33|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.33
71758761|NCT02233517|143019940|SUPERIORITY|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|Mean Difference (Net)|0.11|STANDARD_ERROR_OF_MEAN|0.1||0.26|TWO_SIDED||||||Mixed Models Analysis|||Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.26
71758762|NCT02233517|143019941|SUPERIORITY||Mean Difference (Net)|-0.14|STANDARD_ERROR_OF_MEAN|1.16||0.9|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.90
71758763|NCT02233517|143019941|SUPERIORITY||Mean Difference (Net)|0.22|STANDARD_ERROR_OF_MEAN|1.16||0.85|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.85
71758764|NCT02233517|143019941|SUPERIORITY||Mean Difference (Net)|0.31|STANDARD_ERROR_OF_MEAN|1.16||0.79|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.79
71758765|NCT02233517|143019942|SUPERIORITY||Mean Difference (Net)|-2.3|STANDARD_DEVIATION|3.2||0.05|TWO_SIDED|95.0|-4.5|-0.002|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.||-.002|-4.5|0.05
71758766|NCT02233517|143019942|SUPERIORITY||Mean Difference (Net)|-0.47|STANDARD_DEVIATION|2.09||0.53|TWO_SIDED|95.0|-2.03|1.08|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.||1.08|-2.03|0.53
71758767|NCT02233517|143019942|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_DEVIATION|2.42||0.5|TWO_SIDED|95.0|-2.3|1.14|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.||1.14|-2.30|0.50
71758768|NCT02233517|143019943|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001|TWO_SIDED||||||Mixed Models Analysis||The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).||||<0.0001
71758769|NCT02233517|143019944|SUPERIORITY||Mean Difference (Net)|1.45|STANDARD_ERROR_OF_MEAN|2.71||0.59|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.59
71758770|NCT02233517|143019944|SUPERIORITY||Mean Difference (Net)|1.37|STANDARD_ERROR_OF_MEAN|2.71||0.61|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.61
71758771|NCT02233517|143019944|SUPERIORITY||Mean Difference (Net)|-0.89|STANDARD_ERROR_OF_MEAN|2.71||0.74|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.74
71758772|NCT02233517|143019945|SUPERIORITY||Mean Difference (Net)|-0.19|STANDARD_ERROR_OF_MEAN|0.16||0.25|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.25
71758773|NCT02233517|143019945|SUPERIORITY||Mean Difference (Net)|0.006|STANDARD_ERROR_OF_MEAN|0.16||0.97|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.97
71758774|NCT02233517|143019945|SUPERIORITY||Mean Difference (Net)|0.07|STANDARD_ERROR_OF_MEAN|0.17||0.69|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.69
71758775|NCT02233517|143019946|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|0.66||0.29|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.29
71758776|NCT02233517|143019946|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.66||0.44|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.44
71758777|NCT02233517|143019946|SUPERIORITY||Mean Difference (Net)|-1.06|STANDARD_ERROR_OF_MEAN|0.66||0.11|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.11
71758778|NCT02233517|143019947|SUPERIORITY||Mean Difference (Net)|0.17|STANDARD_ERROR_OF_MEAN|0.12||0.16|TWO_SIDED||||||Mixed Models Analysis||Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in PTSD in PCT).|Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.||||0.16
71758779|NCT02233517|143019948|SUPERIORITY||Mean Difference (Net)|0.28|STANDARD_ERROR_OF_MEAN|0.37||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.|||||0.45
71758780|NCT02233517|143019948|SUPERIORITY||Mean Difference (Net)|-0.23|STANDARD_ERROR_OF_MEAN|0.37||0.55|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.55
71758781|NCT02233517|143019948|SUPERIORITY||Mean Difference (Net)|0.06|STANDARD_ERROR_OF_MEAN|0.37||0.87|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.87
71758782|NCT02233517|143019949|SUPERIORITY||Mean Difference (Net)|-0.71|STANDARD_ERROR_OF_MEAN|1.04||0.49|TWO_SIDED||||||Mixed Models Analysis||Baseline to post-treatment.|||||0.49
71758783|NCT02233517|143019949|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|1.04||0.7|TWO_SIDED||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.|||||0.70
71758784|NCT02233517|143019949|SUPERIORITY||Mean Difference (Net)|-0.78|STANDARD_ERROR_OF_MEAN|1.04||0.45|TWO_SIDED||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.|||||0.45
71758785|NCT00942604|143019954|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71758786|NCT00942604|143019955|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Cochran-Mantel-Haenszel|||||||0.001
71758787|NCT00363480|143019975|SUPERIORITY_OR_OTHER||Percentage diffrence|-30.6|||<|0.0001|TWO_SIDED|95.0|-37.89|-23.29|||McNemar|||Comparison between GOAL and ACT response||-23.29|-37.89|<0.0001
71758788|NCT00363480|143019976|SUPERIORITY_OR_OTHER||t-Distribution|50.2|||||TWO_SIDED|95.0|43.15|57.32||||||||57.32|43.15|
71758789|NCT05567783|143019992|SUPERIORITY||Relative risk reduction (RRR, %)|15.85||||0.5552|TWO_SIDED|95.0|-49.27|52.56||two-sided, alpha=0.05|Poisson regression|Estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model|RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group was the only factor in the model|||52.56|-49.27|0.5552
71758790|NCT05567783|143019992|SUPERIORITY||Relative risk reduction (RRR, %)|3.78|||||TWO_SIDED|95.0|-67.23|44.63|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||44.63|-67.23|
71758791|NCT05567783|143020000|SUPERIORITY||Relative risk reduction (RRR, %)|57.23|||||TWO_SIDED|95.0|-2.51|82.15|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||82.15|-2.51|
71758792|NCT05567783|143020000|SUPERIORITY||Relative risk reduction (RRR, %)|11.45|||||TWO_SIDED|95.0|-76.25|55.51|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||55.51|-76.25|
71758793|NCT05567783|143020001|SUPERIORITY||Relative risk reduction (RRR, %)|44.13|||||TWO_SIDED|95.0|-50.49|79.26|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.|||79.26|-50.49|
71758794|NCT05567783|143020001|SUPERIORITY||Relative risk reduction (RRR, %)|-9.8|||||TWO_SIDED|95.0|-147.41|51.27|||||RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.|||51.27|-147.41|
71758795|NCT04916587|143020008|SUPERIORITY||Risk Difference (RD)|11.6|||||TWO_SIDED|95.0|10.6|12.6||||||||12.6|10.6|
71758796|NCT04916587|143020009|SUPERIORITY||Risk Difference (RD)|7.5|||||TWO_SIDED|95.0|6.6|8.3||||||||8.3|6.6|
71758797|NCT04916587|143020010|SUPERIORITY||Odds Ratio (OR)|0.36||||0.03|TWO_SIDED|90.0|0.14|0.89|||Mixed Models Analysis|||||0.89|0.14|0.03
71758798|NCT02048670|143020014|SUPERIORITY|||||||0.005|||||||Kruskal-Wallis|||Condition 1 - eyes open, visual surround locked, platform locked||||0.005
71758799|NCT02048670|143020014|SUPERIORITY|||||||0.006|||||||Kruskal-Wallis|||Condition 2 - eyes closed, visual surround locked, platform locked||||0.006
71758800|NCT02048670|143020014|SUPERIORITY|||||||0.051|||||||Kruskal-Wallis|||Condition 3 - eyes open, visual surround unlocked, platform locked||||0.051
71758801|NCT02048670|143020014|SUPERIORITY|||||||0.173|||||||Kruskal-Wallis|||Condition 4 - eyes open, visual surround locked, platform unlocked||||0.173
71758802|NCT02048670|143020014|SUPERIORITY|||||||0.985|||||||Kruskal-Wallis|||Condition 5 - eyes closed, visual surround locked, platform unlocked||||0.985
71758803|NCT02048670|143020014|SUPERIORITY|||||||0.003|||||||Kruskal-Wallis|||Condition 6 - eyes open, visual surround unlocked, platform unlocked||||0.003
71758804|NCT00630838|143020047|SUPERIORITY_OR_OTHER||||||=|0.897|TWO_SIDED||||||t-test, 2 sided|||||||=0.897
71758805|NCT01424072|143020052|SUPERIORITY_OR_OTHER|||||||0.023||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.023
71758806|NCT01424072|143020053|SUPERIORITY_OR_OTHER||||||,|0||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|This result was only to the domain Social Support.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days) and at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0,022
71758807|NCT01424072|143020054|SUPERIORITY_OR_OTHER|||||||0.039||95.0||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.||||0.039
71758808|NCT01424072|143020054|SUPERIORITY_OR_OTHER|||||||0.029||95.0|||||ANOVA|It was carried out the analysis of variance (ANOVA) among the groups at the follow up and then it was used the post hoc test.||Coping Strategy: Confrontation domain||||0.029
71758809|NCT04145349|143020076|SUPERIORITY||Posterior Mean Hazard Ratio|0.69|||||TWO_SIDED|98.0|0.25|1.69|||Bayesian hierarchical model|||The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.|The posterior probability treatment difference is 0.864|1.69|0.25|
71758810|NCT01148979|143020083|OTHER|A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.|||||<|0.05|TWO_SIDED|95.0|||||t-test, 2 sided|||The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.||||<0.05
71758811|NCT00904033|143020109|OTHER|||||||0.86|||||||ANCOVA|Main Effects Results only for No Exercise vs Exercise||||||0.86
71758812|NCT00904033|143020110|OTHER|||||||0.19|||||||ANCOVA|||||||0.19
71758813|NCT00904033|143020111|OTHER|||||||0.49|||||||ANCOVA|||||||0.49
71758814|NCT00904033|143020112|OTHER||||||<|0.01|||||||ANCOVA|||||||<0.01
71758815|NCT00904033|143020113|OTHER|||||||0.16|||||||t-test, 2 sided|||||||0.16
71758816|NCT00904033|143020114|OTHER|||||||0.84|||||||t-test, 2 sided|||||||0.84
71758817|NCT00904033|143020115|OTHER|||||||0.38|||||||t-test, 2 sided|||||||0.38
71758818|NCT00904033|143020116|OTHER|||||||0.92|||||||t-test, 2 sided|||||||0.92
71758819|NCT01357850|143020117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0119||||0.7873|TWO_SIDED|95.0|-0.0768|0.1005|||ANOVA|||||0.1005|-0.0768|0.7873
71758820|NCT01357850|143020117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0678||||0.0499|TWO_SIDED|95.0|0.0|0.1356|||ANOVA|||||0.1356|0.0000|0.0499
71758821|NCT01357850|143020117|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0467||||0.1666|TWO_SIDED|95.0|-0.0204|0.1137|||ANOVA|||||0.1137|-0.0204|0.1666
71758822|NCT01357850|143020118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|134.89||||0.9343|TWO_SIDED|95.0|-3172.05|3441.83|||ANOVA|||||3441.83|-3172.05|0.9343
71758823|NCT01357850|143020118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1278.77||||0.3375|TWO_SIDED|95.0|-1398.13|3955.68|||ANOVA|||||3955.68|-1398.13|0.3375
71758824|NCT01357850|143020118|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|772.7||||0.5582|TWO_SIDED|95.0|-1887.77|3433.17|||ANOVA|||||3433.17|-1887.77|0.5582
71758825|NCT01357850|143020119|SUPERIORITY_OR_OTHER||Median Difference (Final Values)|-2.06||||0.2256|TWO_SIDED|95.0|-5.43|1.3|||ANOVA|||||1.30|-5.43|0.2256
71758826|NCT01357850|143020119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.95||||0.5647|TWO_SIDED|95.0|-4.22|2.32|||ANOVA|||||2.32|-4.22|0.5647
71758827|NCT01357850|143020119|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18||||0.8942|TWO_SIDED|95.0|-2.44|2.79|||ANOVA|||||2.79|-2.44|0.8942
71758828|NCT00865566|143020179|OTHER|Score test|Hazard Ratio (HR)|0.73|||<|0.001|TWO_SIDED|95.0|0.63|0.84|||Regression, Cox||HR is vaccine / placebo|Cox proportional hazards model to assess the association between treatment assignment and dropout||0.84|0.63|<0.001
71758829|NCT00865566|143020180|OTHER||Hazard Ratio (HR)|0.77||||0.05|TWO_SIDED|95.0|0.59|1.0||Score test|Regression, Cox||HR is vaccine / placebo|Cox PH model to assess the association between treatment assignment and dropout||1|0.59|0.05
71758830|NCT00865566|143020181|OTHER||Cox Proportional Hazard|0.71|||<|0.001|TWO_SIDED|95.0|0.6|0.84||Score test|Regression, Cox||HR is vaccine / placebo|Assess the association between treatment assignment and dropout||0.84|0.60|<0.001
71758831|NCT00865566|143020182|OTHER||Hazard Ratio (HR)|1.02||||0.903|TWO_SIDED|95.0|0.73|1.42||Score test|Regression, Cox|Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI|HR is vaccine / placebo|||1.42|0.73|0.903
71758832|NCT00865566|143020183|OTHER||Hazard Ratio (HR)|1.06||||0.783|TWO_SIDED|95.0|0.71|1.58||Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI|Regression, Cox|Score test|HR is vaccine / placebo|||1.58|0.71|0.783
71758833|NCT03847896|143020234|SUPERIORITY||Mean Difference (Final Values)|60.5||||0.025|TWO_SIDED|95.0|7.7|113.4|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||113.4|7.7|0.025
71758834|NCT03847896|143020234|SUPERIORITY||Mean Difference (Final Values)|161.9|||<|0.001|TWO_SIDED|95.0|109.4|214.5|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||214.5|109.4|<0.001
71758835|NCT03847896|143020234|SUPERIORITY||Mean Difference (Final Values)|80.7||||0.003|TWO_SIDED|95.0|28.4|132.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||132.9|28.4|0.003
71758836|NCT03847896|143020235|SUPERIORITY||Mean Difference (Final Values)|73.3||||0.037|TWO_SIDED|95.0|4.4|142.2|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||142.2|4.4|0.037
71758837|NCT03847896|143020235|SUPERIORITY||Mean Difference (Final Values)|99.9||||0.005|TWO_SIDED|95.0|30.9|168.8|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||168.8|30.9|0.005
71758838|NCT03847896|143020235|SUPERIORITY||Mean Difference (Final Values)|132.8|||<|0.001|TWO_SIDED|95.0|63.6|201.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||201.9|63.6|<0.001
71758839|NCT03847896|143020235|SUPERIORITY||Mean Difference (Final Values)|87.9||||0.013|TWO_SIDED|95.0|18.8|156.9|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||156.9|18.8|0.013
71758840|NCT03847896|143020235|SUPERIORITY||Mean Difference (Final Values)|120.8|||<|0.001|TWO_SIDED|95.0|51.5|190.1|||ANCOVA|||Only includes data from date of first dose up to date of last dose of randomized treatment. A sequential testing strategy is used such that the primary hypothesis tests are listed in ascending order of sequence. A null hypothesis can only be rejected if all preceding null hypotheses are also rejected. Tests are each conducted at the 5% level of significance.||190.1|51.5|<0.001
71758841|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-2.5|||||TWO_SIDED|95.0|-6.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-6|
71758842|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|3.0|||||TWO_SIDED|95.0|-3.0|9.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||9|-3|
71758843|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
71758844|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-4.5|||||TWO_SIDED|95.0|-9.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-9|
71758845|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-1.5|||||TWO_SIDED|95.0|-3.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-3|
71758846|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-1.0|||||TWO_SIDED|95.0|-2.0|0.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||0|-2|
71758847|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
71758848|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|-6.5|||||TWO_SIDED|95.0|-11.0|-2.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||-2|-11|
71758849|NCT03847896|143020236|SUPERIORITY||Median Difference (Final Values)|0.0|||||TWO_SIDED|95.0|-1.0|1.0||||||Not type-I error controlled. The estimated median difference and 95% CIs are calculated using the Hodges-Lehmann method.||1|-1|
71758850|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|0.699||||0.118|TWO_SIDED|95.0|0.445|1.096|||Regression, Logistic|||Comparison is not type-I error controlled.||1.096|0.445|0.118
71758851|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|1.386||||0.161|TWO_SIDED|95.0|0.878|2.187|||Regression, Logistic|||Comparison is not type-I error controlled.||2.187|0.878|0.161
71758852|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|1.605||||0.044|TWO_SIDED|95.0|1.013|2.541|||Regression, Logistic|||Comparison is not type-I error controlled.||2.541|1.013|0.044
71758853|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|1.626||||0.039|TWO_SIDED|95.0|1.024|2.584|||Regression, Logistic|||Comparison is not type-I error controlled.||2.584|1.024|0.039
71758854|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|2.297|||<|0.001|TWO_SIDED|95.0|1.456|3.626|||Regression, Logistic|||Comparison is not type-I error controlled.||3.626|1.456|<0.001
71758855|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|2.328|||<|0.001|TWO_SIDED|95.0|1.471|3.687|||Regression, Logistic|||Comparison is not type-I error controlled.||3.687|1.471|<0.001
71758856|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|1.158||||0.532|TWO_SIDED|95.0|0.731|1.835|||Regression, Logistic|||Comparison is not type-I error controlled.||1.835|0.731|0.532
71758857|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|1.174||||0.499|TWO_SIDED|95.0|0.737|1.868|||Regression, Logistic|||Comparison is not type-I error controlled.||1.868|0.737|0.499
71758858|NCT03847896|143020238|SUPERIORITY||Odds Ratio (OR)|1.014||||0.955|TWO_SIDED|95.0|0.635|1.618|||Regression, Logistic|||Comparison is not type-I error controlled.||1.618|0.635|0.955
71758859|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|-42.1||||0.169|TWO_SIDED|95.0|-101.9|17.8|||ANCOVA|||Comparison is not type-I error controlled.||17.8|-101.9|0.169
71758860|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|52.1||||0.086|TWO_SIDED|95.0|-7.4|111.5|||ANCOVA|||Comparison is not type-I error controlled.||111.5|-7.4|0.086
71758861|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|30.7||||0.31|TWO_SIDED|95.0|-28.6|90.1|||ANCOVA|||Comparison is not type-I error controlled.||90.1|-28.6|0.31
71758862|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|65.9||||0.03|TWO_SIDED|95.0|6.3|125.4|||ANCOVA|||Comparison is not type-I error controlled.||125.4|6.3|0.03
71758863|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|72.8||||0.017|TWO_SIDED|95.0|13.1|132.5|||ANCOVA|||Comparison is not type-I error controlled.||132.5|13.1|0.017
71758864|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|107.9|||<|0.001|TWO_SIDED|95.0|48.1|167.8|||ANCOVA|||Comparison is not type-I error controlled.||167.8|48.1|<0.001
71758865|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|-21.3||||0.48|TWO_SIDED|95.0|-80.5|37.9|||ANCOVA|||Comparison is not type-I error controlled.||37.9|-80.5|0.48
71758866|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|13.8||||0.648|TWO_SIDED|95.0|-45.6|73.2|||ANCOVA|||Comparison is not type-I error controlled.||73.2|-45.6|0.648
71758867|NCT03847896|143020239|SUPERIORITY||Mean Difference (Final Values)|35.1||||0.246|TWO_SIDED|95.0|-24.2|94.5|||ANCOVA|||Comparison is not type-I error controlled.||94.5|-24.2|0.246
71758868|NCT00118417|143020240|SUPERIORITY_OR_OTHER|||||||0||95.0||||Paired t-test between endpoint and baseline PDSS|t-test, 2 sided|Degrees of Freedom = 38||||||0.0000
71758869|NCT00118417|143020241|SUPERIORITY_OR_OTHER|||||||0.97||95.0||||T-test of PDSS change score|t-test, 2 sided|Degrees of Freedom = 22||||||0.97
71758870|NCT00118417|143020242|SUPERIORITY_OR_OTHER|||||||0.061||95.0||||T-test of PDSS change between baseline and endpoint of Phase 3|t-test, 2 sided|Degrees of Freedom = 17||||||0.061
71758871|NCT02978781|143020244|SUPERIORITY||Least Squares Mean Difference|0.02|STANDARD_ERROR_OF_MEAN|0.227||0.9143|TWO_SIDED|95.0|-0.44|0.49|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14 (predose)|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.49|-0.44|0.9143
71758872|NCT02978781|143020245|OTHER||Least Squares Mean Difference|-1.74|STANDARD_ERROR_OF_MEAN|0.815||0.0529|TWO_SIDED|95.0|-3.5|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-3.50|0.0529
71758873|NCT02978781|143020251|SUPERIORITY||Least Squares Mean Difference|-0.38|STANDARD_ERROR_OF_MEAN|1.326||0.7795|TWO_SIDED|95.0|-3.47|2.7|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.70|-3.47|0.7795
71758874|NCT02978781|143020252|SUPERIORITY||Least Squares Mean Difference|0.34|STANDARD_ERROR_OF_MEAN|0.473||0.4846|TWO_SIDED|95.0|-0.65|1.33|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.33|-0.65|0.4846
71758875|NCT02978781|143020252|SUPERIORITY||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.845||0.4567|TWO_SIDED|95.0|-2.7|1.36|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.36|-2.70|0.4567
71758876|NCT02978781|143020253|SUPERIORITY||Least Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.85||0.3771|TWO_SIDED|95.0|-2.48|0.96|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.96|-2.48|0.3771
71758877|NCT02978781|143020254|SUPERIORITY||Least Squares Mean Difference|-0.14|STANDARD_ERROR_OF_MEAN|0.415||0.7302|TWO_SIDED|95.0|-0.97|0.69|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization in Forward outstretched postural tremor (FOPT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.69|-0.97|0.7302
71758878|NCT02978781|143020254|SUPERIORITY||Least Squares Mean Difference|-0.13|STANDARD_ERROR_OF_MEAN|0.467||0.7916|TWO_SIDED|95.0|-1.1|0.85|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|"Change from Randomization in Lateral wing beating postural tremor (LWBPT) at Day 14"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.85|-1.10|0.7916
71758879|NCT02978781|143020255|SUPERIORITY||Least Squares Mean Difference|-0.47|STANDARD_ERROR_OF_MEAN|0.34||0.1807|TWO_SIDED|95.0|-1.17|0.23|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Randomization (SAGE-217 - placebo)|Change from Randomization at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.23|-1.17|0.1807
71758880|NCT02978781|143020256|SUPERIORITY||Least Squares Mean Difference|0.1|STANDARD_ERROR_OF_MEAN|0.72||0.8709|TWO_SIDED|95.0|-1.7|1.9|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline(SAGE-217 - placebo)|Change from Baseline in Archimedes Spirals (AS) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.9|-1.7|0.8709
71758881|NCT02978781|143020256|SUPERIORITY||Least Squares Mean Difference|-0.2|STANDARD_ERROR_OF_MEAN|0.65||0.7843|TWO_SIDED|95.0|-1.8|1.4|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo)|Change from Baseline in Handwriting at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|1.4|-1.8|0.7843
71758882|NCT02978781|143020256|SUPERIORITY||Least Squares Mean Difference|-0.31|STANDARD_ERROR_OF_MEAN|0.984||0.7604|TWO_SIDED|95.0|-2.72|2.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217 - placebo|Change from Baseline in Dot approximation task (DAT) at Day 14|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|2.10|-2.72|0.7604
71758883|NCT02978781|143020257|OTHER||Least Squares Mean Difference|-0.48|STANDARD_ERROR_OF_MEAN|0.301||0.1333|TWO_SIDED|95.0|-1.13|0.17|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.17|-1.13|0.1333
71758884|NCT02978781|143020257|OTHER||Least Squares Mean Difference|-0.81|STANDARD_ERROR_OF_MEAN|0.389||0.0572|TWO_SIDED|95.0|-1.64|0.03|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.03|-1.64|0.0572
71758885|NCT02978781|143020257|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.255||0.0707|TWO_SIDED|95.0|-1.05|0.05|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.05|-1.05|0.0707
71758886|NCT02978781|143020258|OTHER||Least Squares Mean Difference|-1.53|STANDARD_ERROR_OF_MEAN|0.628||0.0278|TWO_SIDED|95.0|-2.87|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-2.87|0.0278
71758887|NCT02978781|143020259|OTHER||Least Squares Mean Difference|-0.01|STANDARD_ERROR_OF_MEAN|0.258||0.9579|TWO_SIDED|95.0|-0.57|0.54|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Forward outstretched postural tremor (FOPT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.54|-0.57|0.9579
71758888|NCT02978781|143020259|OTHER||Least Squares Mean Difference|-0.8|STANDARD_ERROR_OF_MEAN|0.234||0.0039|TWO_SIDED|95.0|-1.31|-0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|"Change from Baseline in Lateral wing beating postural tremor (LWBPT) at Day 15"|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.30|-1.31|0.0039
71758889|NCT02978781|143020259|OTHER||Least Squares Mean Difference|-0.67|STANDARD_ERROR_OF_MEAN|0.223||0.0099|TWO_SIDED|95.0|-1.14|-0.19|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Kinetic tremor (KT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.19|-1.14|0.0099
71758890|NCT02978781|143020260|OTHER||Least Squares Mean Difference|-0.6|STANDARD_ERROR_OF_MEAN|0.41||0.1595|TWO_SIDED|95.0|-1.5|0.3|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Archimedes spirals (AS) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.3|-1.5|0.1595
71758891|NCT02978781|143020260|OTHER||Least Squares Mean Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.19||0.0126|TWO_SIDED|95.0|-0.9|-0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Handwriting at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|-0.1|-0.9|0.0126
71758892|NCT02978781|143020260|OTHER||Least Squares Mean Difference|-0.23|STANDARD_ERROR_OF_MEAN|0.151||0.1536|TWO_SIDED|95.0|-0.55|0.1|||Mixed Model for Repeated Measures (MMRM)||Least squares mean difference from Baseline (SAGE-217)|Change from Baseline in Dot approximation task (DAT) at Day 15|MMRM model was used for analysis with change from randomization of the Kinesia kinetic tremor combined scores as the dependent variable, treatment group by study visit/time point interaction as fixed effects, and randomization value as a covariate.|0.10|-0.55|0.1536
71758893|NCT00785785|143020269|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.466||||0.0081|TWO_SIDED|95.0|1.104|1.945|||Hazard Ratio|||||1.945|1.104|0.0081
71758894|NCT02453321|143020270|SUPERIORITY|||||||0.355|||||||Kruskal-Wallis|||||||0.355
71758895|NCT02453321|143020271|SUPERIORITY|||||||0.065|||||||Kruskal-Wallis|||||||0.065
71758896|NCT00357552|143020274|NON_INFERIORITY_OR_EQUIVALENCE|Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.|proportion|87.0|||||TWO_SIDED|90.0|81.0|92.0|||confidence interval|Success was determined by whether the lower bound of the 90% exact confidence interval was greater than 65%.|exact confidence interval|The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.||92|81|
71758897|NCT01383356|143020312|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (GMR) in percent|118.0|||||TWO_SIDED|90.0|111.0|125.0|||||Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||125|111|
71758898|NCT01383356|143020312|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|122.0|||||TWO_SIDED|90.0|114.0|130.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).||130|114|
71758899|NCT01383356|143020313|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
71758900|NCT01383356|143020313|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
71758901|NCT01383356|143020314|NON_INFERIORITY_OR_EQUIVALENCE|Bioequivalence (BE), AUC0-inf was no BE criteria|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.||108|101|
71758902|NCT01383356|143020314|NON_INFERIORITY_OR_EQUIVALENCE|BE, AUC0-inf was no BE criteria|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).||112|105|
71758903|NCT00602472|143020333|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.62|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|-0.73|-0.5|||ANCOVA|||Linagliptin vs. Placebo||-0.50|-0.73|<0.0001
71758904|NCT00602472|143020334|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.49|STANDARD_ERROR_OF_MEAN|0.04|<|0.0001||95.0|-0.56|-0.41|||ANCOVA|||Linagliptin vs. Placebo||-0.41|-0.56|<0.0001
71758905|NCT00602472|143020335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.68|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.78|-0.58|||ANCOVA|||Linagliptin vs. Placebo||-0.58|-0.78|<0.0001
71758906|NCT00602472|143020336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.69|STANDARD_ERROR_OF_MEAN|0.05|<|0.0001||95.0|-0.8|-0.59|||ANCOVA|||Linagliptin vs. Placebo||-0.59|-0.80|<0.0001
71758907|NCT00602472|143020337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.7|STANDARD_ERROR_OF_MEAN|2.8|<|0.0001||95.0|-18.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo||-7.3|-18.1|<0.0001
71758908|NCT00602472|143020338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-17.8|STANDARD_ERROR_OF_MEAN|2.3|<|0.0001||95.0|-22.4|-13.2|||ANCOVA|||Linagliptin vs. Placebo||-13.2|-22.4|<0.0001
71758909|NCT00602472|143020339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-15.7|STANDARD_ERROR_OF_MEAN|2.4|<|0.0001||95.0|-20.3|-11.1|||ANCOVA|||Linagliptin vs. Placebo||-11.1|-20.3|<0.0001
71758910|NCT00602472|143020340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.1|STANDARD_ERROR_OF_MEAN|2.6|<|0.0001||95.0|-17.2|-7.1|||ANCOVA|||Linagliptin vs. Placebo||-7.1|-17.2|<0.0001
71758911|NCT00602472|143020341|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.51|||<|0.0001||95.0|3.332|9.111|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||9.111|3.332|<0.0001
71758912|NCT00602472|143020343|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.818|||<|0.0001||95.0|1.989|7.327|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||7.327|1.989|<0.0001
71758913|NCT00602472|143020345|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|3.36|||<|0.0001||95.0|2.474|4.562|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."||4.562|2.474|<0.0001
71758914|NCT03038880|143020346|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.1|||||TWO_SIDED|80.0|-6.8|2.6|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|||2.6|-6.8|
71758915|NCT03038880|143020346|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.1|||||TWO_SIDED|80.0|-3.4|5.5|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|||5.5|-3.4|
71758916|NCT03038880|143020347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-2.09|||||TWO_SIDED|80.0|-6.75|2.56|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||2.56|-6.75|
71758917|NCT03038880|143020347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.05|||||TWO_SIDED|80.0|-3.4|5.49|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||5.49|-3.40|
71758918|NCT03038880|143020347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.49|||||TWO_SIDED|80.0|-4.26|5.25|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||5.25|-4.26|
71758919|NCT03038880|143020347|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.83|||||TWO_SIDED|80.0|-2.71|6.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||6.37|-2.71|
71758920|NCT03038880|143020349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-15.92|25.44|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||25.44|-15.92|
71758921|NCT03038880|143020349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|5.95|||||TWO_SIDED|80.0|-13.62|25.53|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||25.53|-13.62|
71758922|NCT03038880|143020349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.17|||||TWO_SIDED|80.0|-24.52|16.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||16.19|-24.52|
71758923|NCT03038880|143020349|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|8.93|||||TWO_SIDED|80.0|-10.73|28.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.59|-10.73|
71758924|NCT03038880|143020351|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-4.76|||||TWO_SIDED|80.0|-10.72|1.19|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||1.19|-10.72|
71758925|NCT03038880|143020351|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
71758926|NCT03038880|143020351|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||||
71758927|NCT03038880|143020351|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|-3.57|||||TWO_SIDED|80.0|-8.07|0.92|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||0.92|-8.07|
71758928|NCT03038880|143020352|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|21.9|||||TWO_SIDED|80.0|0.76|43.05|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||43.05|0.76|
71758929|NCT03038880|143020352|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|38.57|||||TWO_SIDED|80.0|19.56|57.59|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||57.59|19.56|
71758930|NCT03038880|143020352|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|19.64|||||TWO_SIDED|80.0|-1.14|40.43|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||40.43|-1.14|
71758931|NCT03038880|143020352|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|33.93|||||TWO_SIDED|80.0|14.95|52.91|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||52.91|14.95|
71758932|NCT03038880|143020353|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|0.0|||||||||||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||||
71758933|NCT03038880|143020353|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
71758934|NCT03038880|143020353|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|4.76|||||TWO_SIDED|80.0|-1.19|10.72|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||10.72|-1.19|
71758935|NCT03038880|143020353|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Difference in Percentage of Participants|3.57|||||TWO_SIDED|80.0|-0.92|8.07|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||8.07|-0.92|
71758936|NCT03038880|143020354|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|0.45|||||TWO_SIDED|80.0|-29.81|30.71|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||30.71|-29.81|
71758937|NCT03038880|143020354|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|14.68|||||TWO_SIDED|80.0|-14.29|43.65|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||43.65|-14.29|
71758938|NCT03038880|143020354|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-4.85|||||TWO_SIDED|80.0|-30.57|20.87|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||20.87|-30.57|
71758939|NCT03038880|143020354|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|1.12|||||TWO_SIDED|80.0|-23.57|25.8|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||25.80|-23.57|
71758940|NCT03038880|143020355|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-12.23|||||TWO_SIDED|80.0|-36.6|12.15|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q12W vs. Ranibizumab Q4W||12.15|-36.60|
71758941|NCT03038880|143020355|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|4.98|||||TWO_SIDED|80.0|-18.5|28.45|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 40: Faricimab Q16W vs. Ranibizumab Q4W||28.45|-18.50|
71758942|NCT03038880|143020355|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|-8.64|||||TWO_SIDED|80.0|-30.42|13.14|||||The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q12W vs. Ranibizumab Q4W||13.14|-30.42|
71758943|NCT03038880|143020355|OTHER|The focus of this trial was estimation rather than hypothesis testing.|Mean Difference (Net)|7.36|||||TWO_SIDED|80.0|-13.65|28.37|||||The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.|Week 52: Faricimab Q16W vs. Ranibizumab Q4W||28.37|-13.65|
71758944|NCT02054104|143020377|OTHER|||||||0.36|||||||Mann-Whitney U test|||||||0.36
71758945|NCT03926611|143020382|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-13.66|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-17.51|-9.81|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.81|-17.51|<0.0001
71758946|NCT03926611|143020382|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-13.64|STANDARD_ERROR_OF_MEAN|2.336|<|0.0001|TWO_SIDED|90.0|-17.49|-9.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-9.78|-17.49|<0.0001
71758947|NCT03926611|143020382|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-9.21|STANDARD_ERROR_OF_MEAN|2.277|<|0.0001|TWO_SIDED|90.0|-12.97|-5.45|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.45|-12.97|<0.0001
71758948|NCT03926611|143020382|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-10.55|STANDARD_ERROR_OF_MEAN|2.319|<|0.0001|TWO_SIDED|90.0|-14.38|-6.72|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-6.72|-14.38|<0.0001
71758949|NCT03926611|143020382|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-14.58|STANDARD_ERROR_OF_MEAN|2.334|<|0.0001|TWO_SIDED|90.0|-18.43|-10.73|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-10.73|-18.43|<0.0001
71758950|NCT03926611|143020382|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-12.62|STANDARD_ERROR_OF_MEAN|2.327|<|0.0001|TWO_SIDED|90.0|-16.45|-8.78|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-8.78|-16.45|<0.0001
71758951|NCT03926611|143020383|SUPERIORITY|LOU064 10 mg q.d.|LS Mean|-10.24|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|90.0|-14.72|-5.77|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.77|-14.72|<0.0001
71758952|NCT03926611|143020383|SUPERIORITY|LOU064 35 mg q.d.|LS Mean|-10.11|STANDARD_ERROR_OF_MEAN|2.711||0.0001|TWO_SIDED|90.0|-14.58|-5.63|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.63|-14.58|0.0001
71758953|NCT03926611|143020383|SUPERIORITY|LOU064 100 mg q.d.|LS Mean|-7.4|STANDARD_ERROR_OF_MEAN|2.635||0.0027|TWO_SIDED|90.0|-11.75|-3.05|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-3.05|-11.75|0.0027
71758954|NCT03926611|143020383|SUPERIORITY|LOU064 10 mg b.i.d.|LS Mean|-9.8|STANDARD_ERROR_OF_MEAN|2.696||0.0002|TWO_SIDED|90.0|-14.25|-5.35|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.35|-14.25|0.0002
71758955|NCT03926611|143020383|SUPERIORITY|LOU064 25 mg b.i.d.|LS Mean|-12.35|STANDARD_ERROR_OF_MEAN|2.714|<|0.0001|TWO_SIDED|90.0|-16.82|-7.87|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-7.87|-16.82|<0.0001
71758956|NCT03926611|143020383|SUPERIORITY|LOU064 100 mg b.i.d.|LS Mean|-9.52|STANDARD_ERROR_OF_MEAN|2.733||0.0003|TWO_SIDED|90.0|-14.03|-5.01|||Mixed Models Analysis|Treatment contrast in LS mean (Change)||||-5.01|-14.03|0.0003
71758957|NCT00084136|143020391|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|1.51|||<|0.01|TWO_SIDED|95.0|1.12|2.04||Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Log Rank|Log-rank test was stratified by country and screening RNA (\< 100,000 c/mL vs \>= 100,000 copies/mL).|The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.|||2.04|1.12|<0.01
71758958|NCT00084136|143020392|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.95|||||TWO_SIDED|95.0|0.72|1.27|||Other||The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.|While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.||1.27|0.72|
71758959|NCT02230670|143020410|SUPERIORITY||Mean Difference (Final Values)|-0.14|STANDARD_ERROR_OF_MEAN|0.0817||0.091|TWO_SIDED|95.0|-0.302|0.023|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.023|-0.302|0.091
71758960|NCT02230670|143020410|SUPERIORITY||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.21||0.041|TWO_SIDED|95.0|-0.41|0.01|||ANCOVA|||The analysis was conducted using an ANCOVA model adjusting for baseline value, baseline MELD score, and etiology. The significance was assessed using Type II Sums of Squares from this ANCOVA model.||0.01|-0.41|0.041
71758961|NCT02230670|143020411|SUPERIORITY||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.333||0.466|TWO_SIDED|95.0|-0.91|0.42|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.||0.42|-0.91|0.466
71758962|NCT02230670|143020411|SUPERIORITY||Median Difference (Final Values)|-2.19|STANDARD_ERROR_OF_MEAN|1.42||0.003|TWO_SIDED|95.0|-3.61|-0.77|||ANCOVA|calculated from the estimated least square means for the treatment by BL MELD category interaction term.||BL MELD \>= 15 subgroup results (N=19), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.77|-3.61|0.003
71758963|NCT02230670|143020411|SUPERIORITY||Median Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.46||0.029|TWO_SIDED|95.0|-3.09|-0.17|||ANCOVA|calculated from the estimated least square means for the treatment by etiology interaction term.||NASH Etiology subgroup results (N=20), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.||-0.17|-3.09|0.029
71758964|NCT00414596|143020418|SUPERIORITY_OR_OTHER|||||||0.0001|||||||Mixed Models Analysis|The primary pain end-point was assessed by a mixed effect model with time (visit) and as fixed effects and subject as random effect.||"Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience \>50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients."||||.0001
71758965|NCT00297258|143020430|SUPERIORITY_OR_OTHER||percentage of participants|46.0||||0.653||90.0|11.0|47.6|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||47.6|11.0|0.653
71758966|NCT00297258|143020430|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
71758967|NCT00297258|143020430|SUPERIORITY_OR_OTHER||percentage of participants|49.0|||<|0.001||90.0|34.3|63.2|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||63.2|34.3|<0.001
71758968|NCT00297258|143020430|SUPERIORITY_OR_OTHER||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.|||55.5|28.4|0.003
71758969|NCT05038982|143020434|SUPERIORITY||Mean Difference (Net)|78.26|STANDARD_ERROR_OF_MEAN|16.15|<|0.001|TWO_SIDED|95.0|38.09|118.48||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||118.48|38.09|<0.001
71758970|NCT05038982|143020434|SUPERIORITY||Mean Difference (Net)|53.66|STANDARD_ERROR_OF_MEAN|18.12||0.0142|TWO_SIDED|95.0|8.55|98.76||Threshold of significance at 0.05.|ANOVA||Percent PP-NRS reduction comparing subject's values at Week 0 to values at Week 12|||98.76|8.55|0.0142
71758971|NCT05038982|143020436|SUPERIORITY||Mean Difference (Net)|9.4|STANDARD_ERROR_OF_MEAN|1.37||0.002|TWO_SIDED|95.0|6.3|12.5||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||12.5|6.3|0.002
71758972|NCT05038982|143020436|SUPERIORITY||Mean Difference (Net)|6.1|STANDARD_ERROR_OF_MEAN|1.99||0.0215|TWO_SIDED|95.0|1.6|10.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||10.6|1.6|0.0215
71758973|NCT05038982|143020437|SUPERIORITY||Mean Difference (Net)|10.1|STANDARD_ERROR_OF_MEAN|1.86||0.002|TWO_SIDED|95.0|5.9|14.3||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||14.3|5.9|0.002
71758974|NCT05038982|143020437|SUPERIORITY||Mean Difference (Net)|4.7|STANDARD_ERROR_OF_MEAN|1.74||0.02|TWO_SIDED|95.0|0.77|8.6||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.6|0.77|0.02
71758975|NCT05038982|143020438|SUPERIORITY||Mean Difference (Net)|5.44|STANDARD_ERROR_OF_MEAN|1.21||0.0078|TWO_SIDED|95.0|2.7|8.18||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||8.18|2.70|0.0078
71758976|NCT05038982|143020439|SUPERIORITY||Mean Difference (Net)|12.73|STANDARD_ERROR_OF_MEAN|3.16||0.0098|TWO_SIDED|95.0|5.57|19.89||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||19.89|5.57|0.0098
71758977|NCT05038982|143020439|SUPERIORITY||Mean Difference (Net)|9.88|STANDARD_ERROR_OF_MEAN|3.0||0.0117|TWO_SIDED|95.0|3.1|16.66||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||16.66|3.10|0.0117
71758978|NCT05038982|143020440|SUPERIORITY||Mean Difference (Net)|10.2|STANDARD_ERROR_OF_MEAN|2.54||0.002|TWO_SIDED|95.0|4.46|15.94||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||15.94|4.46|0.002
71758979|NCT05038982|143020441|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|0.23||0.0078|TWO_SIDED|95.0|0.57|1.63||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||1.63|0.57|0.0078
71758980|NCT05038982|143020442|SUPERIORITY||Mean Difference (Net)|0.15|STANDARD_ERROR_OF_MEAN|0.055||0.0391|TWO_SIDED|95.0|0.025|0.27||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.27|0.025|0.0391
71758981|NCT05038982|143020442|SUPERIORITY||Mean Difference (Net)|0.12|STANDARD_ERROR_OF_MEAN|0.086||0.28|TWO_SIDED|95.0|-0.08|0.31||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||0.31|-.080|0.28
71758982|NCT05038982|143020443|SUPERIORITY||Mean Difference (Net)|3.6|STANDARD_ERROR_OF_MEAN|1.607||0.0684|TWO_SIDED|95.0|0.035|7.235||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.235|0.035|0.0684
71758983|NCT05038982|143020443|SUPERIORITY||Mean Difference (Net)|1.1|STANDARD_ERROR_OF_MEAN|1.13||0.375|TWO_SIDED|95.0|-3.656|1.456||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||||1.456|-3.656|0.375
71758984|NCT05038982|143020444|SUPERIORITY||Mean Difference (Net)|0.7|STANDARD_ERROR_OF_MEAN|1.212||0.207|TWO_SIDED|95.0|-3.44|2.04||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||2.04|-3.44|0.207
71758985|NCT05038982|143020444|SUPERIORITY||Mean Difference (Net)|0.0|STANDARD_ERROR_OF_MEAN|1.498||0.8125|TWO_SIDED|95.0|-3.389|3.389||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||3.389|-3.389|0.8125
71758986|NCT05038982|143020445|SUPERIORITY||Mean Difference (Net)|4.8|STANDARD_ERROR_OF_MEAN|1.009||0.0039|TWO_SIDED|95.0|2.52|7.08||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||7.08|2.52|0.0039
71758987|NCT05038982|143020445|SUPERIORITY||Mean Difference (Net)|2.3|STANDARD_ERROR_OF_MEAN|1.033||0.0547|TWO_SIDED|95.0|-0.0376|4.638||Threshold of significance at 0.05.|Wilcoxon matched pairs signed rank test|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||4.638|-0.0376|0.0547
71758988|NCT05038982|143020446|SUPERIORITY||Mean Difference (Net)|9.0||||0.0003|TWO_SIDED|95.0|6.93|11.07||Threshold of significance at 0.05.|t-test, 2 sided|||We are comparing baseline scores at Week 0 to scores taken at the end of the treatment period in Week 12.||11.07|6.93|0.0003
71758989|NCT05038982|143020447|SUPERIORITY||Mean Difference (Net)|6.429|||<|0.0001|TWO_SIDED|95.0|4.011|8.846||Threshold of significance at 0.05.|t-test, 2 sided|||||8.846|4.011|<0.0001
71758990|NCT05038982|143020449|SUPERIORITY||Median Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.12|<|0.0001|TWO_SIDED|95.0|-0.83|-0.33||Threshold of significance set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNA sequencing (RNASeq) performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.33|-0.83|<0.0001
71758991|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.37|STANDARD_ERROR_OF_MEAN|0.091||0.0003|TWO_SIDED|95.0|-0.56|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.18|-0.56|0.0003
71758992|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.21|STANDARD_ERROR_OF_MEAN|0.12||0.0952|TWO_SIDED|95.0|-0.47|0.039||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||0.039|-0.47|0.0952
71758993|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.38|STANDARD_ERROR_OF_MEAN|0.12||0.004|TWO_SIDED|95.0|-0.64|-0.13||Threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for CPUO patient skin at Week 0 versus Week 12 (end of treatment) The CPUO patients only had one biopsy collected at the timepoints because there are no visible lesions. CPUO patients only had one biopsy taken which will be referred to as Lesional sites. CPUO will compare Lesional biopsies at week 0 to Lesional biopsies at week 12.||-0.13|-0.64|0.004
71758994|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.43|STANDARD_ERROR_OF_MEAN|0.18||0.0277|TWO_SIDED|95.0|-0.81|-0.053||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at week 0.||-0.053|-0.81|0.0277
71758995|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.4|STANDARD_ERROR_OF_MEAN|0.22||0.077|TWO_SIDED|95.0|-0.85|0.049||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th1 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at week 12.||0.049|-0.85|0.077
71758996|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.33|STANDARD_ERROR_OF_MEAN|0.15||0.0363|TWO_SIDED|95.0|-0.64|-0.024||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.024|-0.64|0.0363
71758997|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.29|STANDARD_ERROR_OF_MEAN|0.17||0.1|TWO_SIDED|95.0|-0.63|0.062||The threshold of significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th2 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.062|-0.63|0.10
71758998|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.58|STANDARD_ERROR_OF_MEAN|0.15||0.0009|TWO_SIDED|95.0|-0.89|-0.27||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.27|-0.89|0.0009
71758999|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.28|STANDARD_ERROR_OF_MEAN|0.23||0.2326|TWO_SIDED|95.0|-0.77|0.2||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th17 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.20|-0.77|0.2326
71759000|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.52|STANDARD_ERROR_OF_MEAN|0.16||0.0047|TWO_SIDED|95.0|-0.85|-0.18||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 0 versus non lesional PN patient skin at Week 0.||-0.18|-0.85|0.0047
71759001|NCT05038982|143020449|SUPERIORITY||Mean Difference (Net)|-0.41|STANDARD_ERROR_OF_MEAN|0.2||0.0539|TWO_SIDED|95.0|-0.83|0.0076||The threshold for significance is set at 0.05|t-test, 2 sided|||This is a comparison of Th22 GSVA from RNASeq performed on skin biopsies. The comparison is for lesional PN patient skin at Week 12 versus non lesional PN patient skin at Week 12.||0.0076|-0.83|0.0539
71759002|NCT03070964|143020471|SUPERIORITY||Exact binomial estimator|16.7|||||TWO_SIDED|95.0|2.1|48.4||||||||48.4|2.1|
71759003|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.0135||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline Hgb \<10.80 versus modeled Hgb change from baseline in participants with Baseline Hgb \>= 10.80||||0.0135
71759004|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.5082||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline weight \<= 80.5 Kg versus modeled Hgb change from baseline in participants with Baseline weight \> 80.5||||0.5082
71759005|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.977||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino versus modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino||||0.9770
71759006|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.0618||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline geographic ancestry as African American versus modeled Hgb change from baseline in participants with no geographic ancestry as African American||||0.0618
71759007|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.7495||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline gender as male versus modeled Hgb change from baseline in participants with Baseline gender female||||0.7495
71759008|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.7865||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline age \<65 years versus modeled Hgb change from baseline in participants with Baseline age \>=65 years||||0.7865
71759009|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.0622||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline co-ad with food versus modeled Hgb change from baseline in participants with Baseline co-ad without food||||0.0622
71759010|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.2044||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline diabetes presence versus modeled Hgb change from baseline in participants with no Baseline diabetes||||0.2044
71759011|NCT01587924|143020480|SUPERIORITY_OR_OTHER|||||||0.8537||95.0||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline region as the US and Canada versus modeled Hgb change from baseline in participants with Baseline region as not the US and Canada||||0.8537
71759012|NCT00357903|143020538|SUPERIORITY_OR_OTHER||Standardized incidence rate|0.0||||||95.0|0.0|53.87||||||||53.87|0.00|
71759013|NCT00357903|143020538|SUPERIORITY_OR_OTHER||Standardized incidence rate|1.3||||||95.0|0.97|1.71||||||||1.71|0.97|
71759014|NCT00606593|143020540|SUPERIORITY_OR_OTHER||Least square means treatment effect|-10.4||||0.0018|TWO_SIDED|95.0|-17.0|-3.9|||Linear model|||||-3.9|-17.0|0.0018
71759015|NCT00606593|143020540|SUPERIORITY_OR_OTHER||Least square means treatment effect|-19.2|||<|0.0001|TWO_SIDED|95.0|-25.7|-12.6|||Linear model|||||-12.6|-25.7|<0.0001
71759016|NCT00606593|143020540|SUPERIORITY_OR_OTHER||Least square means treatment effect|-31.4|||<|0.0001|TWO_SIDED|95.0|-38.0|-24.9|||Linear model|||||-24.9|-38.0|<0.0001
71759017|NCT00606593|143020540|SUPERIORITY_OR_OTHER||Least square means treatment effect|-46.5|||<|0.0001|TWO_SIDED|95.0|-53.3|-39.9|||Linear model|||||-39.9|-53.3|<0.0001
71759018|NCT00606593|143020541|SUPERIORITY_OR_OTHER||Least square means treatment effect|14.3|||<|0.0001|TWO_SIDED|95.0|7.4|21.2|||Linear model|||||21.2|7.4|<0.0001
71759019|NCT00606593|143020541|SUPERIORITY_OR_OTHER||Least square means treatment effect|21.5|||<|0.0001|TWO_SIDED|95.0|14.6|28.4|||Linear model|||||28.4|14.6|<0.0001
71759020|NCT00606593|143020541|SUPERIORITY_OR_OTHER||Least square means treatment effect|34.7|||<|0.0001|TWO_SIDED|95.0|27.8|41.6|||Linear model|||||41.6|27.8|<0.0001
71759021|NCT00606593|143020541|SUPERIORITY_OR_OTHER||Least square means treatment effect|55.1|||<|0.0001|TWO_SIDED|95.0|48.2|62.0|||Linear model|||||62.0|48.2|<0.0001
71759022|NCT06042855|143020559|SUPERIORITY|Posterior probability of efficacy (P(HR\>1))|Hazard Ratio (HR)|0.96|||||TWO_SIDED|95.0|0.89|1.03|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|||1.03|0.89|
71759023|NCT06042855|143020560|SUPERIORITY||Hazard Ratio (HR)|1.43|||||TWO_SIDED|95.0|0.32|6.38||||||No hypothesis test or decision rule was evaluated.||6.38|0.32|
71759024|NCT06042855|143020563|SUPERIORITY||Hazard Ratio (HR)|1.25|||||TWO_SIDED|95.0|0.82|1.78|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.78|0.82|
71759025|NCT06042855|143020564|SUPERIORITY||Odds Ratio (OR)|0.99|||||TWO_SIDED|95.0|0.66|1.31|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.31|0.66|
71759026|NCT06042855|143020565|SUPERIORITY||Odds Ratio (OR)|0.96|||||TWO_SIDED|95.0|0.57|1.41|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.41|0.57|
71759027|NCT06042855|143020566|SUPERIORITY||Odds Ratio (OR)|1.08|||||TWO_SIDED|95.0|0.78|1.42|||||The interval is a highest-density credible interval. Adjustment variables: randomization, age, sex, duration of symptoms prior to study drug, calendar time, vaccination status, geographic region, call center indicator, and baseline symptom severity.|No hypothesis test or decision rule was evaluated.||1.42|0.78|
71759028|NCT06042855|143020574|SUPERIORITY|Posterior probability of efficacy (P(Difference in MTU (Active - Placebo)\<0))|Difference in model estimate time unwell|0.03|||||TWO_SIDED|95.0|-0.21|0.28|||||The mean time unwell is estimated from receipt of study drug to study day 14. The interval is a highest density credible interval.|No hypothesis test or decision rule was evaluated.||0.28|-0.21|
71759029|NCT06042855|143020575|SUPERIORITY|Posterior probability of efficacy (P(Difference days benefit (Active - Placebo)\>0))|Difference in model estimate time unwell|-0.04|||||TWO_SIDED|95.0|-0.34|0.26|||||The interval is a highest density credible interval.|Analysis is exploratory. No hypothesis test or decision rule was evaluated.||0.26|-0.34|
71759030|NCT02379091|143020585|SUPERIORITY_OR_OTHER||Least Squares (LS) Mean Difference|-0.61|STANDARD_ERROR_OF_MEAN|0.351||0.086|TWO_SIDED|95.0|-1.31|0.09||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.09|-1.31|0.086
71759031|NCT02379091|143020585|SUPERIORITY_OR_OTHER||LS Mean|-0.6|STANDARD_ERROR_OF_MEAN|0.366||0.107|TWO_SIDED|95.0|-1.32|0.13||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||0.13|-1.32|0.107
71759032|NCT02379091|143020585|SUPERIORITY_OR_OTHER||LS Mean Difference|-0.92|STANDARD_ERROR_OF_MEAN|0.347||0.01|TWO_SIDED|95.0|-1.61|-0.23||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo|||-0.23|-1.61|0.010
71759033|NCT02129699|143020596|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.96||||0.355|TWO_SIDED|95.0|0.78|1.19|||Regression, Cox|Cox regression model for treatment effect, analysis adjusted for stratification factors||||1.19|0.78|0.355
71759034|NCT02129699|143020597|SUPERIORITY|Pre-specified analysis|Hazard Ratio (HR)|0.99||||0.459|TWO_SIDED|95.0|0.82|1.19|||Regression, Cox|||||1.19|0.82|0.459
71759035|NCT02350296|143020695|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|108.12||||0.1455|TWO_SIDED|94.12|97.57|119.81||"treatment P value reported"|ANOVA||Estimated value and limits are expressed in %|||119.81|97.57|0.1455
71759036|NCT02350296|143020696|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.62||||0.0023|TWO_SIDED|94.12|104.26|117.38||"Treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.38|104.26|0.0023
71759037|NCT02350296|143020697|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.|geometric means ratio|110.69||||0.0021|TWO_SIDED|94.12|104.35|117.41||"treatment P value is reported"|ANOVA||Estimated value and limits are expressed in %|||117.41|104.35|0.0021
71759038|NCT02350296|143020698|EQUIVALENCE|Acceptance criterion for bioequivalence was a 94.12% confidence interval for the test/reference ratio of the geometric means within the 80.00-125.00% range, according to the current guidelines for bioequivalence studies.||||||0.0201|||||||Friedman|||||||0.0201
71759039|NCT01544335|143020709|OTHER||||||<|0.001|||||||Correlation coefficient|The correlation between RVC and ΔL-Dex values was plotted, and the correlation strength was assessed using the Pearson correlation coefficient, r.||||||<0.001
71759040|NCT01532986|143020718|SUPERIORITY||Mean Difference (Final Values)|0.189|||>|0.05|TWO_SIDED|95.0|0.157|0.222|||t-test, 2 sided|||||0.222|0.157|>0.05
71759041|NCT01532986|143020719|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.04|0.08|||t-test, 2 sided|||||0.08|-0.04|>0.05
71759042|NCT01532986|143020720|SUPERIORITY||Mean Difference (Final Values)|0.02|||>|0.05|TWO_SIDED|95.0|-0.52|0.57|||t-test, 2 sided|||||0.57|-0.52|>0.05
71759043|NCT01532986|143020721|SUPERIORITY||Mean Difference (Final Values)|-0.12|||>|0.05|TWO_SIDED|95.0|-0.34|0.1|||t-test, 2 sided|||||0.10|-0.34|>0.05
71759044|NCT01532986|143020722|SUPERIORITY||Mean Difference (Final Values)|-0.88|||>|0.05|TWO_SIDED|95.0|-2.04|0.29|||t-test, 2 sided|||||0.29|-2.04|>0.05
71759045|NCT01532986|143020723|SUPERIORITY||Mean Difference (Final Values)|1.22|||>|0.05|TWO_SIDED|95.0|-8.02|10.46|||t-test, 2 sided|||||10.46|-8.02|>0.05
71759046|NCT01532986|143020724|SUPERIORITY||Mean Difference (Final Values)|0.17|||>|0.05|TWO_SIDED|95.0|0.0|0.34|||t-test, 2 sided|||||0.34|0.00|>0.05
71759047|NCT01532986|143020725|SUPERIORITY||Mean Difference (Final Values)|-0.06|||>|0.05|TWO_SIDED|95.0|-1.45|1.33|||t-test, 2 sided|||||1.33|-1.45|>0.05
71759048|NCT01532986|143020726|SUPERIORITY||Mean Difference (Final Values)|-11.52|||<|0.05|TWO_SIDED|95.0|-20.42|-2.62|||t-test, 2 sided|||||-2.62|-20.42|<0.05
71759049|NCT01532986|143020727|SUPERIORITY||Mean Difference (Final Values)|-1.98|||>|0.05|TWO_SIDED|95.0|-4.2|0.24|||t-test, 2 sided|||||0.24|-4.20|>0.05
71759050|NCT04614974|143020728|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71759051|NCT04614974|143020729|SUPERIORITY|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||||||0.8
71759052|NCT04614974|143020730|OTHER|||||||0.5|||||||McNemar|||Noisy breathing pre/post||||0.5
71759053|NCT04614974|143020730|OTHER|||||||0.01|||||||McNemar|||Noisy breathing pre/post||||0.01
71759054|NCT04614974|143020730|OTHER|||||||0.2|||||||McNemar|||Stridor pre/post||||0.2
71759055|NCT04614974|143020730|SUPERIORITY|||||||0.02|||||||McNemar|||Stridor pre/post||||0.02
71759056|NCT04614974|143020730|OTHER|||||||0.5|||||||McNemar|||Chest wall retractions pre/post||||0.5
71759057|NCT04614974|143020730|OTHER|||||||1|||||||McNemar|||Chest wall retractions pre/post||||1.0
71759058|NCT04614974|143020730|OTHER|||||||1|||||||McNemar|||Apnea pre/post||||1.0
71759059|NCT04614974|143020731|OTHER|||||||0.5|||||||McNemar|||Emesis pre/post||||0.5
71759060|NCT04614974|143020731|OTHER|||||||0.07|||||||McNemar|||Emesis pre/post||||0.07
71759061|NCT04614974|143020731|SUPERIORITY|||||||0.06|||||||McNemar|||Choking pre/post||||0.06
71759062|NCT04614974|143020731|OTHER|||||||1|||||||McNemar|||Choking pre/post||||1.0
71759063|NCT04614974|143020731|OTHER|||||||0.02|||||||McNemar|||Coughing pre/post||||0.02
71759064|NCT04614974|143020731|OTHER|||||||1|||||||Wilcoxon (Mann-Whitney)|||Coughing pre/post||||1.0
71759065|NCT04614974|143020731|OTHER|||||||1|||||||McNemar|||Gagging pre/post||||1.0
71759066|NCT04614974|143020732|SUPERIORITY|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||||||0.3
71759067|NCT04614974|143020733|SUPERIORITY|||||||1|||||||Fisher Exact|||||||1.0
71759068|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA. Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
71759069|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|10.71|STANDARD_ERROR_OF_MEAN|6.26||0.0873|TWO_SIDED|60.0|5.44|15.98|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||15.98|5.44|0.0873
71759070|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|3.93|STANDARD_ERROR_OF_MEAN|5.71||0.4912|TWO_SIDED|60.0|-0.87|8.74|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||8.74|-0.87|0.4912
71759071|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|11.06|STANDARD_ERROR_OF_MEAN|6.61||0.0942|TWO_SIDED|60.0|5.5|16.62|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||16.62|5.50|0.0942
71759072|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|7.31|STANDARD_ERROR_OF_MEAN|6.36||0.2499|TWO_SIDED|60.0|1.96|12.66|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||12.66|1.96|0.2499
71759073|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|13.47|STANDARD_ERROR_OF_MEAN|7.1||0.058|TWO_SIDED|60.0|7.49|19.45|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||19.45|7.49|0.0580
71759074|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|12.62|STANDARD_ERROR_OF_MEAN|7.09||0.075|TWO_SIDED|60.0|6.66|18.59|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||18.59|6.66|0.0750
71759075|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|16.66|STANDARD_ERROR_OF_MEAN|7.75||0.0316|TWO_SIDED|60.0|10.14|23.19|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||23.19|10.14|0.0316
71759076|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||19.53|6.90|0.0783
71759077|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||27.96|12.58|0.0266
71759078|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|13.21|STANDARD_ERROR_OF_MEAN|7.5||0.0783|TWO_SIDED|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||19.53|6.90|0.0783
71759079|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|20.27|STANDARD_ERROR_OF_MEAN|9.14||0.0266|TWO_SIDED|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||27.96|12.58|0.0266
71759080|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|11.02|STANDARD_ERROR_OF_MEAN|7.74||0.1545|TWO_SIDED|60.0|4.51|17.54|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||17.54|4.51|0.1545
71759081|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|18.08|STANDARD_ERROR_OF_MEAN|9.34||0.0528|TWO_SIDED|60.0|10.22|25.94|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||25.94|10.22|0.0528
71759082|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|14.03|STANDARD_ERROR_OF_MEAN|8.45||0.0968|TWO_SIDED|60.0|6.92|21.14|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||21.14|6.92|0.0968
71759083|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||23.85|7.81|0.0966
71759084|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||24.42|9.72|0.0507
71759085|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||23.85|7.81|0.0966
71759086|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|17.07|STANDARD_ERROR_OF_MEAN|8.74||0.0507|TWO_SIDED|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||24.42|9.72|0.0507
71759087|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|15.83|STANDARD_ERROR_OF_MEAN|9.53||0.0966|TWO_SIDED|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||23.85|7.81|0.0966
71759088|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|18.17|STANDARD_ERROR_OF_MEAN|9.56||0.0574|TWO_SIDED|60.0|10.12|26.22|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||26.22|10.12|0.0574
71759089|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|21.08|STANDARD_ERROR_OF_MEAN|11.84||0.0749|TWO_SIDED|60.0|11.12|31.04|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||31.04|11.12|0.0749
71759090|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|3.65|STANDARD_ERROR_OF_MEAN|4.44||0.4116|TWO_SIDED|60.0|-0.09|7.38|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.38|-0.09|0.4116
71759091|NCT00658359|143020740|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.98|STANDARD_ERROR_OF_MEAN|3.69||0.7895|TWO_SIDED|60.0|-4.09|2.12|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.12|-4.09|0.7895
71759092|NCT00658359|143020741|SUPERIORITY_OR_OTHER||Estimated rate difference|2.4|STANDARD_ERROR_OF_MEAN|5.9||0.683|TWO_SIDED|95.0|-9.1|13.9|||Chi-squared||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||13.9|-9.1|0.683
71759093|NCT00658359|143020741|SUPERIORITY_OR_OTHER||Estimated rate difference|3.9|STANDARD_ERROR_OF_MEAN|6.2||0.529|TWO_SIDED|95.0|-8.3|16.1|||Chi-squared||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|||16.1|-8.3|0.529
71759094|NCT00658359|143020742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.23|STANDARD_ERROR_OF_MEAN|5.04||0.0699|TWO_SIDED|60.0|4.97|13.49|||Mixed Models Analysis||Tofacitinib LI minus CsA|||13.49|4.97|0.0699
71759095|NCT00658359|143020742|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.23|STANDARD_ERROR_OF_MEAN|6.32||0.1958|TWO_SIDED|60.0|2.89|13.58|||Mixed Models Analysis||Tofacitinib MI minus CsA|||13.58|2.89|0.1958
71759096|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
71759097|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.41|STANDARD_ERROR_OF_MEAN|4.89||0.934|TWO_SIDED|60.0|-4.52|3.71|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||3.71|-4.52|0.9340
71759098|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||5.08|-3.88|0.9106
71759099|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.30|-6.29|0.6960
71759100|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||5.08|-3.88|0.9106
71759101|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.30|-6.29|0.6960
71759102|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|0.6|STANDARD_ERROR_OF_MEAN|5.32||0.9106|TWO_SIDED|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||5.08|-3.88|0.9106
71759103|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.99|STANDARD_ERROR_OF_MEAN|5.1||0.696|TWO_SIDED|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.30|-6.29|0.6960
71759104|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.18|STANDARD_ERROR_OF_MEAN|5.56||0.8322|TWO_SIDED|60.0|-5.86|3.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||3.50|-5.86|0.8322
71759105|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.77|STANDARD_ERROR_OF_MEAN|5.35||0.4809|TWO_SIDED|60.0|-8.27|0.73|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||0.73|-8.27|0.4809
71759106|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.62|-8.31|0.5704
71759107|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-1.14|-10.73|0.2972
71759108|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||1.62|-8.31|0.5704
71759109|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-1.14|-10.73|0.2972
71759110|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.62|-8.31|0.5704
71759111|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-1.14|-10.73|0.2972
71759112|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.62|-8.31|0.5704
71759113|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-1.14|-10.73|0.2972
71759114|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.62|-8.31|0.5704
71759115|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-1.14|-10.73|0.2972
71759116|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.34|STANDARD_ERROR_OF_MEAN|5.89||0.5704|TWO_SIDED|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.62|-8.31|0.5704
71759117|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.94|STANDARD_ERROR_OF_MEAN|5.7||0.2972|TWO_SIDED|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-1.14|-10.73|0.2972
71759118|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||7.89|-0.39|0.4455
71759119|NCT00658359|143020744|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
71759120|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.52|STANDARD_ERROR_OF_MEAN|5.71||0.0654|TWO_SIDED|60.0|-15.33|-5.71|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-5.71|-15.33|0.0654
71759121|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.08|STANDARD_ERROR_OF_MEAN|6.37||0.3398|TWO_SIDED|60.0|-11.43|-0.72|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.72|-11.43|0.3398
71759122|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.75|STANDARD_ERROR_OF_MEAN|6.23||0.1601|TWO_SIDED|60.0|-13.99|-3.51|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-3.51|-13.99|0.1601
71759123|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.18|-13.10|0.2390
71759124|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.08|STANDARD_ERROR_OF_MEAN|6.4||0.2685|TWO_SIDED|60.0|-12.47|-1.7|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.70|-12.47|0.2685
71759125|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.64|STANDARD_ERROR_OF_MEAN|6.49||0.239|TWO_SIDED|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.18|-13.10|0.2390
71759126|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.81|STANDARD_ERROR_OF_MEAN|6.55||0.1785|TWO_SIDED|60.0|-14.32|-3.3|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.30|-14.32|0.1785
71759127|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-9.37|STANDARD_ERROR_OF_MEAN|6.63||0.158|TWO_SIDED|60.0|-14.95|-3.78|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-3.78|-14.95|0.1580
71759128|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.27|STANDARD_ERROR_OF_MEAN|6.81||0.0718|TWO_SIDED|60.0|-18.0|-6.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-6.53|-18.00|0.0718
71759129|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.83|STANDARD_ERROR_OF_MEAN|6.9||0.0629|TWO_SIDED|60.0|-18.63|-7.02|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-7.02|-18.63|0.0629
71759130|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate differences|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-9.94|-21.84|0.0246
71759131|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-10.43|-22.46|0.0214
71759132|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-15.89|STANDARD_ERROR_OF_MEAN|7.07||0.0246|TWO_SIDED|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-9.94|-21.84|0.0246
71759133|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-16.45|STANDARD_ERROR_OF_MEAN|7.15||0.0214|TWO_SIDED|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-10.43|-22.46|0.0214
71759134|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-11.93|-24.12|0.0128
71759135|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-12.42|-24.74|0.0111
71759136|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-11.93|-24.12|0.0128
71759137|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-12.42|-24.74|0.0111
71759138|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-11.93|-24.12|0.0128
71759139|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-12.42|-24.74|0.0111
71759140|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.02|STANDARD_ERROR_OF_MEAN|7.24||0.0128|TWO_SIDED|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-11.93|-24.12|0.0128
71759141|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-18.58|STANDARD_ERROR_OF_MEAN|7.32||0.0111|TWO_SIDED|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-12.42|-24.74|0.0111
71759142|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.4|STANDARD_ERROR_OF_MEAN|5.41||0.1715|TWO_SIDED|60.0|-11.95|-2.84|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||-2.84|-11.95|0.1715
71759143|NCT00658359|143020745|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.8|STANDARD_ERROR_OF_MEAN|5.87||0.4131|TWO_SIDED|60.0|-9.74|0.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.14|-9.74|0.4131
71759144|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|2.19|STANDARD_ERROR_OF_MEAN|5.12||0.6694|TWO_SIDED|60.0|-2.12|6.5|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||6.50|-2.12|0.6694
71759145|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|1.45|STANDARD_ERROR_OF_MEAN|5.18||0.7799|TWO_SIDED|60.0|-2.91|5.8|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||5.80|-2.91|0.7799
71759146|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||3.65|-5.63|0.8572
71759147|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.73|STANDARD_ERROR_OF_MEAN|5.56||0.7555|TWO_SIDED|60.0|-6.41|2.95|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.95|-6.41|0.7555
71759148|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.99|STANDARD_ERROR_OF_MEAN|5.51||0.8572|TWO_SIDED|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||3.65|-5.63|0.8572
71759149|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|3.82|STANDARD_ERROR_OF_MEAN|6.22||0.539|TWO_SIDED|60.0|-1.41|9.06|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||9.06|-1.41|0.5390
71759150|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.64|STANDARD_ERROR_OF_MEAN|5.7||0.6432|TWO_SIDED|60.0|-7.44|2.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.16|-7.44|0.6432
71759151|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|2.18|STANDARD_ERROR_OF_MEAN|6.39||0.7336|TWO_SIDED|60.0|-3.2|7.55|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||7.55|-3.20|0.7336
71759152|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.74|STANDARD_ERROR_OF_MEAN|6.57||0.9099|TWO_SIDED|60.0|-6.28|4.79|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||4.79|-6.28|0.9099
71759153|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|0.77|STANDARD_ERROR_OF_MEAN|6.87||0.9106|TWO_SIDED|60.0|-5.01|6.56|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||6.56|-5.01|0.9106
71759154|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|6.91||0.5244|TWO_SIDED|60.0|-10.22|1.42|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||1.42|-10.22|0.5244
71759155|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.9|STANDARD_ERROR_OF_MEAN|7.38||0.9029|TWO_SIDED|60.0|-7.11|5.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.31|-7.11|0.9029
71759156|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.58|STANDARD_ERROR_OF_MEAN|7.38||0.7267|TWO_SIDED|60.0|-8.78|3.63|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.63|-8.78|0.7267
71759157|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.73|STANDARD_ERROR_OF_MEAN|7.52||0.7168|TWO_SIDED|60.0|-9.06|3.6|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||3.60|-9.06|0.7168
71759158|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.91|-10.72|0.5574
71759159|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.56|STANDARD_ERROR_OF_MEAN|7.65||0.5515|TWO_SIDED|60.0|-10.99|1.88|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.88|-10.99|0.5515
71759160|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.91|-10.72|0.5574
71759161|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||4.33|-8.92|0.7704
71759162|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.4|STANDARD_ERROR_OF_MEAN|7.51||0.5574|TWO_SIDED|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.91|-10.72|0.5574
71759163|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||4.33|-8.92|0.7704
71759164|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.44|STANDARD_ERROR_OF_MEAN|7.83||0.9551|TWO_SIDED|60.0|-7.03|6.15|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||6.15|-7.03|0.9551
71759165|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.3|STANDARD_ERROR_OF_MEAN|7.87||0.7704|TWO_SIDED|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||4.33|-8.92|0.7704
71759166|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.75|STANDARD_ERROR_OF_MEAN|4.91||0.4455|TWO_SIDED|60.0|-0.39|7.89|||Wald Test|||Month 12||7.89|-0.39|0.4455
71759167|NCT00658359|143020746|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.69|STANDARD_ERROR_OF_MEAN|4.34||0.873|TWO_SIDED|60.0|-4.35|2.96|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||2.96|-4.35|0.8730
71759168|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.98|STANDARD_ERROR_OF_MEAN|6.67||0.2957|TWO_SIDED|60.0|-12.6|-1.36|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-1.36|-12.60|0.2957
71759169|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.65|STANDARD_ERROR_OF_MEAN|7.14||0.6097|TWO_SIDED|60.0|-9.66|2.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||2.37|-9.66|0.6097
71759170|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|6.79||0.2064|TWO_SIDED|60.0|-14.28|-2.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||-2.86|-14.28|0.2064
71759171|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.24|STANDARD_ERROR_OF_MEAN|7.25||0.4696|TWO_SIDED|60.0|-11.34|0.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||0.86|-11.34|0.4696
71759172|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-2.64|-14.50|0.2238
71759173|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.96|STANDARD_ERROR_OF_MEAN|7.52||0.5093|TWO_SIDED|60.0|-11.29|1.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||1.37|-11.29|0.5093
71759174|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-8.57|STANDARD_ERROR_OF_MEAN|7.04||0.2238|TWO_SIDED|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-2.64|-14.50|0.2238
71759175|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.16|STANDARD_ERROR_OF_MEAN|7.89||0.7846|TWO_SIDED|60.0|-8.8|4.48|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||4.48|-8.80|0.7846
71759176|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-10.3|STANDARD_ERROR_OF_MEAN|7.16||0.1501|TWO_SIDED|60.0|-16.33|-4.28|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-4.28|-16.33|0.1501
71759177|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.89|STANDARD_ERROR_OF_MEAN|8.0||0.6263|TWO_SIDED|60.0|-10.62|2.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.84|-10.62|0.6263
71759178|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-6.25|-18.62|0.0905
71759179|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||0.84|-12.90|0.4604
71759180|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-6.25|-18.62|0.0905
71759181|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||0.84|-12.90|0.4604
71759182|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||-6.25|-18.62|0.0905
71759183|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||0.84|-12.90|0.4604
71759184|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||-6.25|-18.62|0.0905
71759185|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||0.84|-12.90|0.4604
71759186|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||-6.25|-18.62|0.0905
71759187|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||0.84|-12.90|0.4604
71759188|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-12.44|STANDARD_ERROR_OF_MEAN|7.35||0.0905|TWO_SIDED|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||-6.25|-18.62|0.0905
71759189|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-6.03|STANDARD_ERROR_OF_MEAN|8.16||0.4604|TWO_SIDED|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||0.84|-12.90|0.4604
71759190|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-2.29|STANDARD_ERROR_OF_MEAN|6.31||0.7166|TWO_SIDED|60.0|-7.61|3.02|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||3.02|-7.61|0.7166
71759191|NCT00658359|143020747|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.51|STANDARD_ERROR_OF_MEAN|6.24||0.4692|TWO_SIDED|60.0|-9.76|0.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12||0.73|-9.76|0.4692
71759192|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
71759193|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|1.69|STANDARD_ERROR_OF_MEAN|1.68||0.3132|TWO_SIDED|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||3.11|0.28|0.3132
71759194|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
71759195|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||5.57|1.46|0.1503
71759196|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
71759197|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.57|1.46|0.1503
71759198|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
71759199|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.57|1.46|0.1503
71759200|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
71759201|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||5.57|1.46|0.1503
71759202|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
71759203|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||5.57|1.46|0.1503
71759204|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
71759205|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||5.57|1.46|0.1503
71759206|NCT00658359|143020748|SUPERIORITY_OR_OTHER||Estimated rate difference|3.52|STANDARD_ERROR_OF_MEAN|2.44||0.1503|TWO_SIDED|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||5.57|1.46|0.1503
71759207|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-1.85|STANDARD_ERROR_OF_MEAN|1.83||0.3128|TWO_SIDED|60.0|-3.4|-0.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15||-0.31|-3.40|0.3128
71759208|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||2.91|0.26|0.3134
71759209|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-0.26|STANDARD_ERROR_OF_MEAN|2.42||0.9129|TWO_SIDED|60.0|-2.3|1.77|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18||1.77|-2.30|0.9129
71759210|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||2.91|0.26|0.3134
71759211|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24||-1.16|-7.23|0.2447
71759212|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||2.91|0.26|0.3134
71759213|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-4.19|STANDARD_ERROR_OF_MEAN|3.61||0.2447|TWO_SIDED|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30||-1.16|-7.23|0.2447
71759214|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|1.59|STANDARD_ERROR_OF_MEAN|1.57||0.3134|TWO_SIDED|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||2.91|0.26|0.3134
71759215|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-7.44|STANDARD_ERROR_OF_MEAN|4.74||0.1164|TWO_SIDED|60.0|-11.43|-3.45|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36||-3.45|-11.43|0.1164
71759216|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||5.93|1.52|0.1545
71759217|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42||-0.94|-9.66|0.3061
71759218|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|3.73|STANDARD_ERROR_OF_MEAN|2.62||0.1545|TWO_SIDED|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||5.93|1.52|0.1545
71759219|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-5.3|STANDARD_ERROR_OF_MEAN|5.18||0.3061|TWO_SIDED|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48||-0.94|-9.66|0.3061
71759220|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||8.73|3.10|0.0774
71759221|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54||1.59|-7.82|0.5772
71759222|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||8.73|3.10|0.0774
71759223|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60||1.59|-7.82|0.5772
71759224|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||8.73|3.10|0.0774
71759225|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66||1.59|-7.82|0.5772
71759226|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|5.91|STANDARD_ERROR_OF_MEAN|3.35||0.0774|TWO_SIDED|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||8.73|3.10|0.0774
71759227|NCT00658359|143020749|SUPERIORITY_OR_OTHER||Estimated rate difference|-3.12|STANDARD_ERROR_OF_MEAN|5.59||0.5772|TWO_SIDED|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72||1.59|-7.82|0.5772
71759228|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.35|STANDARD_ERROR_OF_MEAN|8.15||0.0786|TWO_SIDED|60.0|7.49|21.22|||Mixed Models Analysis|||Month 15||21.22|7.49|0.0786
71759229|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.87|STANDARD_ERROR_OF_MEAN|8.5||0.736|TWO_SIDED|60.0|-10.03|4.29|||Mixed Models Analysis|||Month 15||4.29|-10.03|0.7360
71759230|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.16|STANDARD_ERROR_OF_MEAN|8.19||0.1377|TWO_SIDED|60.0|5.27|19.05|||Mixed Models Analysis|||Month 18||19.05|5.27|0.1377
71759231|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.01|STANDARD_ERROR_OF_MEAN|8.56||0.4131|TWO_SIDED|60.0|-14.21|0.2|||Mixed Models Analysis|||Month 18||0.20|-14.21|0.4131
71759232|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.52|STANDARD_ERROR_OF_MEAN|8.35||0.1057|TWO_SIDED|60.0|6.49|20.55|||Mixed Models Analysis|||Month 24||20.55|6.49|0.1057
71759233|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.21|STANDARD_ERROR_OF_MEAN|8.95||0.1402|TWO_SIDED|60.0|-20.75|-5.68|||Mixed Models Analysis|||Month 24||-5.68|-20.75|0.1402
71759234|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.6|STANDARD_ERROR_OF_MEAN|9.13||0.0542|TWO_SIDED|60.0|9.91|25.29|||Mixed Models Analysis|||Month 30||25.29|9.91|0.0542
71759235|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.74|STANDARD_ERROR_OF_MEAN|10.09||0.3866|TWO_SIDED|60.0|0.24|17.24|||Mixed Models Analysis|||Month 30||17.24|0.24|0.3866
71759236|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.52|STANDARD_ERROR_OF_MEAN|9.72||0.1981|TWO_SIDED|60.0|4.33|20.71|||Mixed Models Analysis|||Month 36||20.71|4.33|0.1981
71759237|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.65|STANDARD_ERROR_OF_MEAN|12.07||0.6397|TWO_SIDED|60.0|-15.81|4.51|||Mixed Models Analysis|||Month 36||4.51|-15.81|0.6397
71759238|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.93|STANDARD_ERROR_OF_MEAN|10.19||0.0508|TWO_SIDED|60.0|11.35|28.51|||Mixed Models Analysis|||Month 42||28.51|11.35|0.0508
71759239|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.42|STANDARD_ERROR_OF_MEAN|12.9||0.5143|TWO_SIDED|60.0|-2.45|19.28|||Mixed Models Analysis|||Month 42||19.28|-2.45|0.5143
71759240|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|32.26|STANDARD_ERROR_OF_MEAN|10.45||0.0021|TWO_SIDED|60.0|23.46|41.06|||Mixed Models Analysis|||Month 48||41.06|23.46|0.0021
71759241|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.73|STANDARD_ERROR_OF_MEAN|13.47||0.5661|TWO_SIDED|60.0|-19.07|3.61|||Mixed Models Analysis|||Month 48||3.61|-19.07|0.5661
71759242|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|29.2|STANDARD_ERROR_OF_MEAN|10.54||0.0057|TWO_SIDED|60.0|20.33|38.08|||Mixed Models Analysis|||Month 54||38.08|20.33|0.0057
71759243|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.49|STANDARD_ERROR_OF_MEAN|13.89||0.4504|TWO_SIDED|60.0|-22.18|1.21|||Mixed Models Analysis|||Month 54||1.21|-22.18|0.4504
71759244|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.37|STANDARD_ERROR_OF_MEAN|11.39||0.0078|TWO_SIDED|60.0|20.78|39.96|||Mixed Models Analysis|||Month 60||39.96|20.78|0.0078
71759245|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.95|STANDARD_ERROR_OF_MEAN|14.44||0.6802|TWO_SIDED|60.0|-18.11|6.2|||Mixed Models Analysis|||Month 60||6.20|-18.11|0.6802
71759246|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|27.78|STANDARD_ERROR_OF_MEAN|12.08||0.0216|TWO_SIDED|60.0|17.61|37.95|||Mixed Models Analysis|||Month 66||37.95|17.61|0.0216
71759247|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|15.12||0.9026|TWO_SIDED|60.0|-14.58|10.88|||Mixed Models Analysis|||Month 66||10.88|-14.58|0.9026
71759248|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|20.38|STANDARD_ERROR_OF_MEAN|12.91||0.1146|TWO_SIDED|60.0|9.51|31.24|||Mixed Models Analysis|||Month 72||31.24|9.51|0.1146
71759249|NCT00658359|143020751|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.14|STANDARD_ERROR_OF_MEAN|15.48||0.6918|TWO_SIDED|60.0|-19.18|6.9|||Mixed Models Analysis|||Month 72||6.90|-19.18|0.6918
71759250|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.62|STANDARD_ERROR_OF_MEAN|6.57||0.3139|TWO_SIDED|60.0|1.09|12.14|||Mixed Models Analysis|||Month 15||12.14|1.09|0.3139
71759251|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.37|STANDARD_ERROR_OF_MEAN|6.75||0.5176|TWO_SIDED|60.0|-10.06|1.31|||Mixed Models Analysis|||Month 15||1.31|-10.06|0.5176
71759252|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.54|STANDARD_ERROR_OF_MEAN|6.56||0.3191|TWO_SIDED|60.0|1.02|12.06|||Mixed Models Analysis|||Month 18||12.06|1.02|0.3191
71759253|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.95|STANDARD_ERROR_OF_MEAN|6.73||0.6608|TWO_SIDED|60.0|-8.62|2.71|||Mixed Models Analysis|||Month 18||2.71|-8.62|0.6608
71759254|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.02|STANDARD_ERROR_OF_MEAN|6.7||0.2319|TWO_SIDED|60.0|2.37|13.66|||Mixed Models Analysis|||Month 24||13.66|2.37|0.2319
71759255|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.5|STANDARD_ERROR_OF_MEAN|7.04||0.3554|TWO_SIDED|60.0|-12.43|-0.58|||Mixed Models Analysis|||Month 24||-0.58|-12.43|0.3554
71759256|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.45|STANDARD_ERROR_OF_MEAN|7.27||0.0113|TWO_SIDED|60.0|12.33|24.57|||Mixed Models Analysis|||Month 30||24.57|12.33|0.0113
71759257|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.66|STANDARD_ERROR_OF_MEAN|7.99||0.479|TWO_SIDED|60.0|-1.07|12.39|||Mixed Models Analysis|||Month 30||12.39|-1.07|0.4790
71759258|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.46|STANDARD_ERROR_OF_MEAN|7.75||0.1776|TWO_SIDED|60.0|3.93|16.99|||Mixed Models Analysis|||Month 36||16.99|3.93|0.1776
71759259|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.27|STANDARD_ERROR_OF_MEAN|9.5||0.7307|TWO_SIDED|60.0|-11.27|4.73|||Mixed Models Analysis|||Month 36||4.73|-11.27|0.7307
71759260|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.53|STANDARD_ERROR_OF_MEAN|8.25||0.1625|TWO_SIDED|60.0|4.59|18.48|||Mixed Models Analysis|||Month 42||18.48|4.59|0.1625
71759261|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.77|STANDARD_ERROR_OF_MEAN|10.12||0.2876|TWO_SIDED|60.0|2.25|19.29|||Mixed Models Analysis|||Month 42||19.29|2.25|0.2876
71759262|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.62|STANDARD_ERROR_OF_MEAN|8.41||0.027|TWO_SIDED|60.0|11.54|25.7|||Mixed Models Analysis|||Month 48||25.70|11.54|0.0270
71759263|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.44|STANDARD_ERROR_OF_MEAN|10.54||0.7444|TWO_SIDED|60.0|-12.31|5.44|||Mixed Models Analysis|||Month 48||5.44|-12.31|0.7444
71759264|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|21.18|STANDARD_ERROR_OF_MEAN|8.44||0.0122|TWO_SIDED|60.0|14.08|28.29|||Mixed Models Analysis|||Month 54||28.29|14.08|0.0122
71759265|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.61|STANDARD_ERROR_OF_MEAN|10.86||0.3288|TWO_SIDED|60.0|-19.75|-1.47|||Mixed Models Analysis|||Month 54||-1.47|-19.75|0.3288
71759266|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.34|STANDARD_ERROR_OF_MEAN|9.15||0.0453|TWO_SIDED|60.0|10.63|26.05|||Mixed Models Analysis|||Month 60||26.05|10.63|0.0453
71759267|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.59|STANDARD_ERROR_OF_MEAN|11.28||0.5016|TWO_SIDED|60.0|-17.09|1.91|||Mixed Models Analysis|||Month 60||1.91|-17.09|0.5016
71759268|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.43|STANDARD_ERROR_OF_MEAN|9.69||0.0453|TWO_SIDED|60.0|11.27|27.59|||Mixed Models Analysis|||Month 66||27.59|11.27|0.0453
71759269|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.87|STANDARD_ERROR_OF_MEAN|11.84||0.8747|TWO_SIDED|60.0|-11.83|8.1|||Mixed Models Analysis|||Month 66||8.10|-11.83|0.8747
71759270|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.98|STANDARD_ERROR_OF_MEAN|10.34||0.4997|TWO_SIDED|60.0|-1.72|15.69|||Mixed Models Analysis|||Month 72||15.69|-1.72|0.4997
71759271|NCT00658359|143020752|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-13.07|STANDARD_ERROR_OF_MEAN|12.1||0.2804|TWO_SIDED|60.0|-23.26|-2.88|||Mixed Models Analysis|||Month 72||-2.88|-23.26|0.2804
71759272|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.79|STANDARD_ERROR_OF_MEAN|2.5|<|0.0001|TWO_SIDED|60.0|7.68|11.9|||Mixed Models Analysis|||Month 15||11.90|7.68|<0.0001
71759273|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.32|STANDARD_ERROR_OF_MEAN|2.61||0.0418|TWO_SIDED|60.0|3.12|7.52|||Mixed Models Analysis|||Month 15||7.52|3.12|0.0418
71759274|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.4|STANDARD_ERROR_OF_MEAN|2.51||0.0002|TWO_SIDED|60.0|7.28|11.51|||Mixed Models Analysis|||Month 18||11.51|7.28|0.0002
71759275|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.3|STANDARD_ERROR_OF_MEAN|2.63||0.0437|TWO_SIDED|60.0|3.09|7.51|||Mixed Models Analysis|||Month 18||7.51|3.09|0.0437
71759276|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.37|STANDARD_ERROR_OF_MEAN|2.56||0.0011|TWO_SIDED|60.0|6.21|10.53|||Mixed Models Analysis|||Month 24||10.53|6.21|0.0011
71759277|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.04|STANDARD_ERROR_OF_MEAN|2.75||0.4565|TWO_SIDED|60.0|-0.27|4.36|||Mixed Models Analysis|||Month 24||4.36|-0.27|0.4565
71759278|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.9|STANDARD_ERROR_OF_MEAN|2.8||0.0001|TWO_SIDED|60.0|8.54|13.26|||Mixed Models Analysis|||Month 30||13.26|8.54|0.0001
71759279|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.29|STANDARD_ERROR_OF_MEAN|3.09||0.1654|TWO_SIDED|60.0|1.69|6.89|||Mixed Models Analysis|||Month 30||6.89|1.69|0.1654
71759280|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.45|STANDARD_ERROR_OF_MEAN|2.98||0.0015|TWO_SIDED|60.0|6.95|11.96|||Mixed Models Analysis|||Month 36||11.96|6.95|0.0015
71759281|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.13|STANDARD_ERROR_OF_MEAN|3.69||0.2636|TWO_SIDED|60.0|1.02|7.23|||Mixed Models Analysis|||Month 36||7.23|1.02|0.2636
71759282|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.08|STANDARD_ERROR_OF_MEAN|3.12||0.052|TWO_SIDED|60.0|3.45|8.71|||Mixed Models Analysis|||Month 42||8.71|3.45|0.0520
71759283|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.35|STANDARD_ERROR_OF_MEAN|3.95||0.176|TWO_SIDED|60.0|2.02|8.67|||Mixed Models Analysis|||Month 42||8.67|2.02|0.1760
71759284|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.08|STANDARD_ERROR_OF_MEAN|3.2||0.0274|TWO_SIDED|60.0|4.38|9.77|||Mixed Models Analysis|||Month 48||9.77|4.38|0.0274
71759285|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.04|STANDARD_ERROR_OF_MEAN|4.13||0.8018|TWO_SIDED|60.0|-4.51|2.44|||Mixed Models Analysis|||Month 48||2.44|-4.51|0.8018
71759286|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.63|STANDARD_ERROR_OF_MEAN|3.23||0.0819|TWO_SIDED|60.0|2.91|8.35|||Mixed Models Analysis|||Month 54||8.35|2.91|0.0819
71759287|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.17|STANDARD_ERROR_OF_MEAN|4.26||0.6103|TWO_SIDED|60.0|-5.75|1.41|||Mixed Models Analysis|||Month 54||1.41|-5.75|0.6103
71759288|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.48|STANDARD_ERROR_OF_MEAN|3.49||0.1168|TWO_SIDED|60.0|2.54|8.41|||Mixed Models Analysis|||Month 60||8.41|2.54|0.1168
71759289|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.26|STANDARD_ERROR_OF_MEAN|4.43||0.3357|TWO_SIDED|60.0|0.54|7.99|||Mixed Models Analysis|||Month 60||7.99|0.54|0.3357
71759290|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.42|STANDARD_ERROR_OF_MEAN|3.7||0.0448|TWO_SIDED|60.0|4.31|10.54|||Mixed Models Analysis|||Month 66||10.54|4.31|0.0448
71759291|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.39|STANDARD_ERROR_OF_MEAN|4.64||0.7642|TWO_SIDED|60.0|-2.51|5.29|||Mixed Models Analysis|||Month 66||5.29|-2.51|0.7642
71759292|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.99|STANDARD_ERROR_OF_MEAN|3.95||0.1295|TWO_SIDED|60.0|2.67|9.32|||Mixed Models Analysis|||Month 72||9.32|2.67|0.1295
71759293|NCT00658359|143020753|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.13|STANDARD_ERROR_OF_MEAN|4.75||0.654|TWO_SIDED|60.0|-1.87|6.13|||Mixed Models Analysis|||Month 72||6.13|-1.87|0.6540
71759294|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.11|STANDARD_ERROR_OF_MEAN|19.53||0.7543|TWO_SIDED|60.0|-22.55|10.33|||Mixed Models Analysis|||Month 15||10.33|-22.55|0.7543
71759295|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.95|STANDARD_ERROR_OF_MEAN|20.33||0.6249|TWO_SIDED|60.0|-27.07|7.17|||Mixed Models Analysis|||Month 15||7.17|-27.07|0.6249
71759296|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-18.66|STANDARD_ERROR_OF_MEAN|19.61||0.3415|TWO_SIDED|60.0|-35.17|-2.15|||Mixed Models Analysis|||Month 18||-2.15|-35.17|0.3415
71759297|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-36.86|STANDARD_ERROR_OF_MEAN|20.47||0.072|TWO_SIDED|60.0|-54.1|-19.63|||Mixed Models Analysis|||Month 18||-19.63|-54.10|0.0720
71759298|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.0|STANDARD_ERROR_OF_MEAN|19.99||0.2937|TWO_SIDED|60.0|-37.83|-4.17|||Mixed Models Analysis|||Month 24||-4.17|-37.83|0.2937
71759299|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-41.72|STANDARD_ERROR_OF_MEAN|21.38||0.0512|TWO_SIDED|60.0|-59.72|-23.73|||Mixed Models Analysis|||Month 24||-23.73|-59.72|0.0512
71759300|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-45.43|STANDARD_ERROR_OF_MEAN|21.76||0.037|TWO_SIDED|60.0|-63.75|-27.11|||Mixed Models Analysis|||Month 30||-27.11|-63.75|0.0370
71759301|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.92|STANDARD_ERROR_OF_MEAN|24.0||0.8701|TWO_SIDED|60.0|-24.13|16.28|||Mixed Models Analysis|||Month 30||16.28|-24.13|0.8701
71759302|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-28.75|STANDARD_ERROR_OF_MEAN|23.15||0.2146|TWO_SIDED|60.0|-48.24|-9.25|||Mixed Models Analysis|||Month 36||-9.25|-48.24|0.2146
71759303|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-21.03|STANDARD_ERROR_OF_MEAN|28.58||0.462|TWO_SIDED|60.0|-45.09|3.03|||Mixed Models Analysis|||Month 36||3.03|-45.09|0.4620
71759304|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.16|STANDARD_ERROR_OF_MEAN|24.28||0.8639|TWO_SIDED|60.0|-16.28|24.6|||Mixed Models Analysis|||Month 42||24.60|-16.28|0.8639
71759305|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-30.3|STANDARD_ERROR_OF_MEAN|30.65||0.323|TWO_SIDED|60.0|-56.11|-4.5|||Mixed Models Analysis|||Month 42||-4.50|-56.11|0.3230
71759306|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|30.49|STANDARD_ERROR_OF_MEAN|24.92||0.2214|TWO_SIDED|60.0|9.51|51.47|||Mixed Models Analysis|||Month 48||51.47|9.51|0.2214
71759307|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-10.25|STANDARD_ERROR_OF_MEAN|32.08||0.7492|TWO_SIDED|60.0|-37.26|16.75|||Mixed Models Analysis|||Month 48||16.75|-37.26|0.7492
71759308|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.61|STANDARD_ERROR_OF_MEAN|25.15||0.8236|TWO_SIDED|60.0|-15.57|26.79|||Mixed Models Analysis|||Month 54||26.79|-15.57|0.8236
71759309|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.67|STANDARD_ERROR_OF_MEAN|33.1||0.6578|TWO_SIDED|60.0|-13.2|42.54|||Mixed Models Analysis|||Month 54||42.54|-13.20|0.6578
71759310|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.93|STANDARD_ERROR_OF_MEAN|27.12||0.5326|TWO_SIDED|60.0|-5.9|39.76|||Mixed Models Analysis|||Month 60||39.76|-5.90|0.5326
71759311|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-14.0|STANDARD_ERROR_OF_MEAN|34.44||0.6845|TWO_SIDED|60.0|-42.99|15.0|||Mixed Models Analysis|||Month 60||15.00|-42.99|0.6845
71759312|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.35|STANDARD_ERROR_OF_MEAN|28.73||0.7713|TWO_SIDED|60.0|-15.83|32.54|||Mixed Models Analysis|||Month 66||32.54|-15.83|0.7713
71759313|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.11|STANDARD_ERROR_OF_MEAN|36.06||0.8438|TWO_SIDED|60.0|-37.47|23.26|||Mixed Models Analysis|||Month 66||23.26|-37.47|0.8438
71759314|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|22.06|STANDARD_ERROR_OF_MEAN|30.7||0.4724|TWO_SIDED|60.0|-3.78|47.91|||Mixed Models Analysis|||Month 72||47.91|-3.78|0.4724
71759315|NCT00658359|143020754|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.25|STANDARD_ERROR_OF_MEAN|36.98||0.6218|TWO_SIDED|60.0|-12.89|49.38|||Mixed Models Analysis|||Month 72||49.38|-12.89|0.6218
71759316|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.33|STANDARD_ERROR_OF_MEAN|7.93||0.7693|TWO_SIDED|60.0|-9.01|4.35|||Mixed Models Analysis|||Month 15||4.35|-9.01|0.7693
71759317|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.75|STANDARD_ERROR_OF_MEAN|8.28||0.7396|TWO_SIDED|60.0|-4.22|9.73|||Mixed Models Analysis|||Month 15||9.73|-4.22|0.7396
71759318|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-6.84|STANDARD_ERROR_OF_MEAN|7.92||0.3881|TWO_SIDED|60.0|-13.51|-0.17|||Mixed Models Analysis|||Month 18||-0.17|-13.51|0.3881
71759319|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-5.44|STANDARD_ERROR_OF_MEAN|8.28||0.5114|TWO_SIDED|60.0|-12.42|1.53|||Mixed Models Analysis|||Month 18||1.53|-12.42|0.5114
71759320|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.43|STANDARD_ERROR_OF_MEAN|8.06||0.5829|TWO_SIDED|60.0|-11.21|2.36|||Mixed Models Analysis|||Month 24||2.36|-11.21|0.5829
71759321|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-9.76|STANDARD_ERROR_OF_MEAN|8.58||0.2559|TWO_SIDED|60.0|-16.99|-2.53|||Mixed Models Analysis|||Month 24||-2.53|-16.99|0.2559
71759322|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.74|STANDARD_ERROR_OF_MEAN|8.78||0.7548|TWO_SIDED|60.0|-4.65|10.14|||Mixed Models Analysis|||Month 30||10.14|-4.65|0.7548
71759323|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.43|STANDARD_ERROR_OF_MEAN|9.57||0.7998|TWO_SIDED|60.0|-5.63|10.49|||Mixed Models Analysis|||Match 30||10.49|-5.63|0.7998
71759324|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.39|STANDARD_ERROR_OF_MEAN|9.08||0.2531|TWO_SIDED|60.0|2.74|18.03|||Mixed Models Analysis|||Month 36||18.03|2.74|0.2531
71759325|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.14|STANDARD_ERROR_OF_MEAN|11.2||0.365|TWO_SIDED|60.0|0.72|19.57|||Mixed Models Analysis|||Month 36||19.57|0.72|0.3650
71759326|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.33|STANDARD_ERROR_OF_MEAN|9.34||0.4328|TWO_SIDED|60.0|-0.53|15.19|||Mixed Models Analysis|||Month 42||15.19|-0.53|0.4328
71759327|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-12.94|STANDARD_ERROR_OF_MEAN|11.35||0.2547|TWO_SIDED|60.0|-22.5|-3.38|||Mixed Models Analysis|||Month 42||-3.38|-22.50|0.2547
71759328|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.72|STANDARD_ERROR_OF_MEAN|9.46||0.3572|TWO_SIDED|60.0|0.75|16.69|||Mixed Models Analysis|||Month 48||16.69|0.75|0.3572
71759329|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.94|STANDARD_ERROR_OF_MEAN|11.64||0.8009|TWO_SIDED|60.0|-6.86|12.74|||Mixed Models Analysis|||Month 48||12.74|-6.86|0.8009
71759330|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.88|STANDARD_ERROR_OF_MEAN|9.44||0.6814|TWO_SIDED|60.0|-11.82|4.07|||Mixed Models Analysis|||Month 54||4.07|-11.82|0.6814
71759331|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.88|STANDARD_ERROR_OF_MEAN|11.93||0.2803|TWO_SIDED|60.0|2.84|22.93|||Mixed Models Analysis|||Month 54||22.93|2.84|0.2803
71759332|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.11|STANDARD_ERROR_OF_MEAN|10.23||0.7613|TWO_SIDED|60.0|-11.72|5.5|||Mixed Models Analysis|||Month 60||5.50|-11.72|0.7613
71759333|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.25|STANDARD_ERROR_OF_MEAN|12.35||0.8554|TWO_SIDED|60.0|-12.65|8.15|||Mixed Models Analysis|||Month 60||8.15|-12.65|0.8554
71759334|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.17|STANDARD_ERROR_OF_MEAN|10.7||0.9132|TWO_SIDED|60.0|-10.18|7.84|||Mixed Models Analysis|||Month 66||7.84|-10.18|0.9132
71759335|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.14|STANDARD_ERROR_OF_MEAN|12.79||0.7465|TWO_SIDED|60.0|-6.63|14.9|||Mixed Models Analysis|||Month 66||14.90|-6.63|0.7465
71759336|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.79|STANDARD_ERROR_OF_MEAN|11.34||0.8747|TWO_SIDED|60.0|-11.34|7.76|||Mixed Models Analysis|||Month 72||7.76|-11.34|0.8747
71759337|NCT00658359|143020758|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-7.19|STANDARD_ERROR_OF_MEAN|12.96||0.5793|TWO_SIDED|60.0|-18.1|3.72|||Mixed Models Analysis|||Month 72||3.72|-18.10|0.5793
71759338|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.76|STANDARD_ERROR_OF_MEAN|2.79|<|0.0001|TWO_SIDED|60.0|10.4|15.11|||Mixed Models Analysis|||Month 15||15.11|10.40|<0.0001
71759339|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|2.88|<|0.0001|TWO_SIDED|60.0|10.96|15.82|||Mixed Models Analysis|||Month 15||15.82|10.96|<0.0001
71759340|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.48|STANDARD_ERROR_OF_MEAN|3.0||0.0002|TWO_SIDED|60.0|8.95|14.0|||Mixed Models Analysis|||Month 18||14.00|8.95|0.0002
71759341|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.98|STANDARD_ERROR_OF_MEAN|3.09||0.0002|TWO_SIDED|60.0|9.37|14.59|||Mixed Models Analysis|||Month 18||14.59|9.37|0.0002
71759342|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.86|STANDARD_ERROR_OF_MEAN|3.0|<|0.0001|TWO_SIDED|60.0|10.32|15.39|||Mixed Models Analysis|||Month 24||15.39|10.32|<0.0001
71759343|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.71|STANDARD_ERROR_OF_MEAN|3.12|<|0.0001|TWO_SIDED|60.0|11.08|16.35|||Mixed Models Analysis|||Month 24||16.35|11.08|<0.0001
71759344|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.86|STANDARD_ERROR_OF_MEAN|3.35|<|0.0001|TWO_SIDED|60.0|13.03|18.69|||Mixed Models Analysis|||Month 30||18.69|13.03|<0.0001
71759345|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.61|STANDARD_ERROR_OF_MEAN|3.56||0.0002|TWO_SIDED|60.0|10.61|16.61|||Mixed Models Analysis|||Month 30||16.61|10.61|0.0002
71759346|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.17|STANDARD_ERROR_OF_MEAN|3.61||0.001|TWO_SIDED|60.0|9.12|15.21|||Mixed Models Analysis|||Month 36||15.21|9.12|0.0010
71759347|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.56|STANDARD_ERROR_OF_MEAN|3.98||0.0019|TWO_SIDED|60.0|9.2|15.92|||Mixed Models Analysis|||Month 36||15.92|9.20|0.0019
71759348|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.42|STANDARD_ERROR_OF_MEAN|3.38||0.0004|TWO_SIDED|60.0|9.56|15.27|||Mixed Models Analysis|||Month 42||15.27|9.56|0.0004
71759349|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.99|STANDARD_ERROR_OF_MEAN|3.76||0.0182|TWO_SIDED|60.0|5.81|12.16|||Mixed Models Analysis|||Month 42||12.16|5.81|0.0182
71759350|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.4|STANDARD_ERROR_OF_MEAN|3.77||0.0013|TWO_SIDED|60.0|9.22|15.58|||Mixed Models Analysis|||Month 48||15.58|9.22|0.0013
71759351|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.6|STANDARD_ERROR_OF_MEAN|4.29||0.0782|TWO_SIDED|60.0|3.99|11.22|||Mixed Models Analysis|||Month 48||11.22|3.99|0.0782
71759352|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.04|STANDARD_ERROR_OF_MEAN|4.02||0.0007|TWO_SIDED|60.0|10.64|17.43|||Mixed Models Analysis|||Month 54||17.43|10.64|0.0007
71759353|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.23|STANDARD_ERROR_OF_MEAN|4.72||0.0322|TWO_SIDED|60.0|6.24|14.22|||Mixed Models Analysis|||Month 54||14.22|6.24|0.0322
71759354|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.72|STANDARD_ERROR_OF_MEAN|3.7||0.0399|TWO_SIDED|60.0|4.59|10.86|||Mixed Models Analysis|||Month 60||10.86|4.59|0.0399
71759355|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.11|STANDARD_ERROR_OF_MEAN|4.28||0.3391|TWO_SIDED|60.0|0.49|7.73|||Mixed Models Analysis|||Month 60||7.73|0.49|0.3391
71759356|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|7.75|STANDARD_ERROR_OF_MEAN|4.23||0.0702|TWO_SIDED|60.0|4.17|11.33|||Mixed Models Analysis|||Month 66||11.33|4.17|0.0702
71759357|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|6.02|STANDARD_ERROR_OF_MEAN|4.89||0.221|TWO_SIDED|60.0|1.89|10.15|||Mixed Models Analysis|||Month 66||10.15|1.89|0.2210
71759358|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.03|STANDARD_ERROR_OF_MEAN|5.25||0.015|TWO_SIDED|60.0|8.59|17.46|||Mixed Models Analysis|||Month 72||17.46|8.59|0.0150
71759359|NCT00658359|143020760|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.27|STANDARD_ERROR_OF_MEAN|6.13||0.4875|TWO_SIDED|60.0|-0.91|9.45|||Mixed Models Analysis|||Month 72||9.45|-0.91|0.4875
71759360|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.48|STANDARD_ERROR_OF_MEAN|4.33||0.001|TWO_SIDED|60.0|10.83|18.13|||Mixed Models Analysis|||Month 15||18.13|10.83|0.0010
71759361|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.47||0.001|TWO_SIDED|60.0|11.16|18.7|||Mixed Models Analysis|||Month 15||18.70|11.16|0.0010
71759362|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.96|STANDARD_ERROR_OF_MEAN|4.5||0.0023|TWO_SIDED|60.0|10.16|17.76|||Mixed Models Analysis|||Month 18||17.76|10.16|0.0023
71759363|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.57|STANDARD_ERROR_OF_MEAN|4.64||0.0039|TWO_SIDED|60.0|9.65|17.48|||Mixed Models Analysis|||Month 18||17.48|9.65|0.0039
71759364|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.02|STANDARD_ERROR_OF_MEAN|4.72||0.0017|TWO_SIDED|60.0|11.04|19.0|||Mixed Models Analysis|||Month 24||19.00|11.04|0.0017
71759365|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|4.88||0.0026|TWO_SIDED|60.0|10.81|19.04|||Mixed Models Analysis|||Month 24||19.04|10.81|0.0026
71759366|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|18.54|STANDARD_ERROR_OF_MEAN|5.06||0.0003|TWO_SIDED|60.0|14.27|22.81|||Mixed Models Analysis|||Month 30||22.81|14.27|0.0003
71759367|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.45|STANDARD_ERROR_OF_MEAN|5.29||0.0022|TWO_SIDED|60.0|11.99|20.91|||Mixed Models Analysis|||Month 30||20.91|11.99|0.0022
71759368|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.19|STANDARD_ERROR_OF_MEAN|5.51||0.0065|TWO_SIDED|60.0|10.55|19.84|||Mixed Models Analysis|||Month 36||19.84|10.55|0.0065
71759369|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.93|STANDARD_ERROR_OF_MEAN|6.0||0.0137|TWO_SIDED|60.0|9.87|19.99|||Mixed Models Analysis|||Month 36||19.99|9.87|0.0137
71759370|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.32|STANDARD_ERROR_OF_MEAN|5.12||0.0018|TWO_SIDED|60.0|11.99|20.64|||Mixed Models Analysis|||Month 42||20.64|11.99|0.0018
71759371|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.24|STANDARD_ERROR_OF_MEAN|5.65||0.0316|TWO_SIDED|60.0|7.47|17.01|||Mixed Models Analysis|||Month 42||17.01|7.47|0.0316
71759372|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.33|STANDARD_ERROR_OF_MEAN|5.64||0.0043|TWO_SIDED|60.0|11.57|21.09|||Mixed Models Analysis|||Month 48||21.09|11.57|0.0043
71759373|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.8|STANDARD_ERROR_OF_MEAN|6.31||0.1226|TWO_SIDED|60.0|4.47|15.12|||Mixed Models Analysis|||Month 48||15.12|4.47|0.1226
71759374|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.97|STANDARD_ERROR_OF_MEAN|5.7||0.0034|TWO_SIDED|60.0|12.17|21.78|||Mixed Models Analysis|||Month 54||21.78|12.17|0.0034
71759375|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.79|STANDARD_ERROR_OF_MEAN|6.52||0.0724|TWO_SIDED|60.0|6.29|17.29|||Mixed Models Analysis|||Month 54||17.29|6.29|0.0724
71759376|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.03|STANDARD_ERROR_OF_MEAN|5.92||0.1782|TWO_SIDED|60.0|3.02|13.03|||Mixed Models Analysis|||Month 60||13.03|3.02|0.1782
71759377|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.66|STANDARD_ERROR_OF_MEAN|6.86||0.5947|TWO_SIDED|60.0|-2.14|9.46|||Mixed Models Analysis|||Month 66||9.46|-2.14|0.5947
71759378|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.99|STANDARD_ERROR_OF_MEAN|5.68||0.081|TWO_SIDED|60.0|5.2|14.79|||Mixed Models Analysis|||Month 66||14.79|5.20|0.0810
71759379|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.42|STANDARD_ERROR_OF_MEAN|6.38||0.3965|TWO_SIDED|60.0|0.04|10.81|||Mixed Models Analysis|||Month 66||10.81|0.04|0.3965
71759380|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|17.16|STANDARD_ERROR_OF_MEAN|6.77||0.0128|TWO_SIDED|60.0|11.44|22.88|||Mixed Models Analysis|||Month 72||22.88|11.44|0.0128
71759381|NCT00658359|143020761|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.71|STANDARD_ERROR_OF_MEAN|7.83||0.5487|TWO_SIDED|60.0|-1.91|11.33|||Mixed Models Analysis|||Month 72||11.33|-1.91|0.5487
71759382|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.87|STANDARD_ERROR_OF_MEAN|2.86|<|0.0001|TWO_SIDED|60.0|13.46|18.29|||Mixed Models Analysis|||Month 15||18.29|13.46|<0.0001
71759383|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.97|STANDARD_ERROR_OF_MEAN|2.95|<|0.0001|TWO_SIDED|60.0|11.49|16.46|||Mixed Models Analysis|||Month 15||16.46|11.49|<0.0001
71759384|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.53|STANDARD_ERROR_OF_MEAN|3.33|<|0.0001|TWO_SIDED|60.0|10.71|16.34|||Mixed Models Analysis|||Month 18||16.34|10.71|<0.0001
71759385|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.56|STANDARD_ERROR_OF_MEAN|3.43||0.0009|TWO_SIDED|60.0|8.67|14.45|||Mixed Models Analysis|||Month 18||14.45|8.67|0.0009
71759386|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|15.63|STANDARD_ERROR_OF_MEAN|3.44|<|0.0001|TWO_SIDED|60.0|12.72|18.53|||Mixed Models Analysis|||Month 24||18.53|12.72|<0.0001
71759387|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.89|STANDARD_ERROR_OF_MEAN|3.54||0.001|TWO_SIDED|60.0|8.91|14.88|||Mixed Models Analysis|||Month 24||14.88|8.91|0.0010
71759388|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.29|STANDARD_ERROR_OF_MEAN|3.86|<|0.0001|TWO_SIDED|60.0|16.03|22.55|||Mixed Models Analysis|||Month 30||22.55|16.03|<0.0001
71759389|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.63|STANDARD_ERROR_OF_MEAN|3.97||0.0082|TWO_SIDED|60.0|7.27|13.98|||Mixed Models Analysis|||Month 30||13.98|7.27|0.0082
71759390|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.72|STANDARD_ERROR_OF_MEAN|4.31||0.0008|TWO_SIDED|60.0|11.09|18.36|||Mixed Models Analysis|||Month 36||18.36|11.09|0.0008
71759391|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.9|STANDARD_ERROR_OF_MEAN|4.43||0.0462|TWO_SIDED|60.0|5.16|12.64|||Mixed Models Analysis|||Month 36||12.64|5.16|0.0462
71759392|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.7|STANDARD_ERROR_OF_MEAN|4.25||0.0007|TWO_SIDED|60.0|11.11|18.28|||Mixed Models Analysis|||Month 42||18.28|11.11|0.0007
71759393|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.55|STANDARD_ERROR_OF_MEAN|4.37||0.0519|TWO_SIDED|60.0|4.87|12.24|||Mixed Models Analysis|||Month 42||12.24|4.87|0.0519
71759394|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.58|STANDARD_ERROR_OF_MEAN|4.65||0.0039|TWO_SIDED|60.0|9.66|17.5|||Mixed Models Analysis|||Month 48||17.50|9.66|0.0039
71759395|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.12|STANDARD_ERROR_OF_MEAN|4.78||0.058|TWO_SIDED|60.0|5.09|13.15|||Mixed Models Analysis|||Month 48||13.15|5.09|0.0580
71759396|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.61|STANDARD_ERROR_OF_MEAN|4.74||0.0006|TWO_SIDED|60.0|12.62|20.61|||Mixed Models Analysis|||Month 54||20.61|12.62|0.0006
71759397|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.15|STANDARD_ERROR_OF_MEAN|4.87||0.0136|TWO_SIDED|60.0|8.04|16.26|||Mixed Models Analysis|||Month 54||16.26|8.04|0.0136
71759398|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.39|STANDARD_ERROR_OF_MEAN|4.74||0.0053|TWO_SIDED|60.0|9.39|17.39|||Mixed Models Analysis|||Month 60||17.39|9.39|0.0053
71759399|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.77|STANDARD_ERROR_OF_MEAN|4.87||0.0736|TWO_SIDED|60.0|4.66|12.88|||Mixed Models Analysis|||Month 60||12.88|4.66|0.0736
71759400|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.63|STANDARD_ERROR_OF_MEAN|4.8||0.005|TWO_SIDED|60.0|9.58|17.67|||Mixed Models Analysis|||Month 66||17.67|9.58|0.0050
71759401|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.77|STANDARD_ERROR_OF_MEAN|4.93||0.0491|TWO_SIDED|60.0|5.61|13.93|||Mixed Models Analysis|||Month 66||13.93|5.61|0.0491
71759402|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.66|STANDARD_ERROR_OF_MEAN|5.04||0.0041|TWO_SIDED|60.0|10.4|18.91|||Mixed Models Analysis|||Month 72||18.91|10.40|0.0041
71759403|NCT00658359|143020762|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.59|STANDARD_ERROR_OF_MEAN|5.19||0.066|TWO_SIDED|60.0|5.22|13.97|||Mixed Models Analysis|||Month 72||13.97|5.22|0.0660
71759404|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.04|STANDARD_ERROR_OF_MEAN|1.73||0.2393|TWO_SIDED|95.0|-5.45|1.36|||Mixed Models Analysis|||Month 24: Physical Functioning||1.36|-5.45|0.2393
71759405|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-3.57|STANDARD_ERROR_OF_MEAN|1.89||0.0595|TWO_SIDED|95.0|-7.29|0.14|||Mixed Models Analysis|||Month 24: Physical Functioning||0.14|-7.29|0.0595
71759406|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.36|STANDARD_ERROR_OF_MEAN|2.1||0.5182|TWO_SIDED|95.0|-2.77|5.49|||Mixed Models Analysis|||Month 24: Role Physical||5.49|-2.77|0.5182
71759407|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.96|STANDARD_ERROR_OF_MEAN|2.3||0.3938|TWO_SIDED|95.0|-6.49|2.56|||Mixed Models Analysis|||Month 24: Role Physical||2.56|-6.49|0.3938
71759408|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.29|STANDARD_ERROR_OF_MEAN|2.12||0.8932|TWO_SIDED|95.0|-3.89|4.46|||Mixed Models Analysis|||Month 24: Bodily Pain||4.46|-3.89|0.8932
71759409|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.1|STANDARD_ERROR_OF_MEAN|2.33||0.9673|TWO_SIDED|95.0|-4.48|4.67|||Mixed Models Analysis|||Month 24: Bodily Pain||4.67|-4.48|0.9673
71759410|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.74|STANDARD_ERROR_OF_MEAN|1.78||0.329|TWO_SIDED|95.0|-1.76|5.23|||Mixed Models Analysis|||Month 24: General Health||5.23|-1.76|0.3290
71759411|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.09|STANDARD_ERROR_OF_MEAN|1.95||0.578|TWO_SIDED|95.0|-2.75|4.92|||Mixed Models Analysis|||Month 24: General Health||4.92|-2.75|0.5780
71759412|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|1.87||0.9799|TWO_SIDED|95.0|-3.72|3.62|||Mixed Models Analysis|||Month 24: Vitality||3.62|-3.72|0.9799
71759413|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.76|STANDARD_ERROR_OF_MEAN|2.07||0.396|TWO_SIDED|95.0|-2.31|5.83|||Mixed Models Analysis|||Month 24: Vitality||5.83|-2.31|0.3960
71759414|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.15|STANDARD_ERROR_OF_MEAN|1.98||0.94|TWO_SIDED|95.0|-4.05|3.75|||Mixed Models Analysis|||Month 24: Social Functioning||3.75|-4.05|0.9400
71759415|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.39|STANDARD_ERROR_OF_MEAN|2.2||0.8583|TWO_SIDED|95.0|-3.94|4.72|||Mixed Models Analysis|||Month 24: Social Functioning||4.72|-3.94|0.8583
71759416|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.82|STANDARD_ERROR_OF_MEAN|2.31||0.0997|TWO_SIDED|95.0|-0.73|8.37|||Mixed Models Analysis|||Month 24: Role Emotional||8.37|-0.73|0.0997
71759417|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|2.54||0.852|TWO_SIDED|95.0|-5.47|4.52|||Mixed Models Analysis|||Month 24: Role Emotional||4.52|-5.47|0.8520
71759418|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.69|STANDARD_ERROR_OF_MEAN|2.01||0.4023|TWO_SIDED|95.0|-5.64|2.27|||Mixed Models Analysis|||Month 24: Mental Health||2.27|-5.64|0.4023
71759419|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.56|STANDARD_ERROR_OF_MEAN|2.22||0.1092|TWO_SIDED|95.0|-0.8|7.92|||Mixed Models Analysis|||Month 24: Mental Health||7.92|-0.80|0.1092
71759420|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.21|STANDARD_ERROR_OF_MEAN|0.16||0.1754|TWO_SIDED|95.0|-0.1|0.52|||Mixed Models Analysis|||Month 24: TR Scale Score||0.52|-0.10|0.1754
71759421|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.23|STANDARD_ERROR_OF_MEAN|0.17||0.1802|TWO_SIDED|95.0|-0.11|0.57|||Mixed Models Analysis|||Month 24: TR Scale Score||0.57|-0.11|0.1802
71759422|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|1.68||0.9966|TWO_SIDED|95.0|-3.31|3.29|||Mixed Models Analysis|||Month 24: Physical Component Summary||3.29|-3.31|0.9966
71759423|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.42|STANDARD_ERROR_OF_MEAN|1.84||0.188|TWO_SIDED|95.0|-6.04|1.19|||Mixed Models Analysis|||Month 24: Physical Component Summary||1.19|-6.04|0.1880
71759424|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|1.92||0.6154|TWO_SIDED|95.0|-2.81|4.73|||Mixed Models Analysis|||Month 24: Mental Component Summary||4.73|-2.81|0.6154
71759425|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|3.26|STANDARD_ERROR_OF_MEAN|2.12||0.1248|TWO_SIDED|95.0|-0.91|7.43|||Mixed Models Analysis|||Month 24: Mental Component Summary||7.43|-0.91|0.1248
71759426|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.65|STANDARD_ERROR_OF_MEAN|2.03||0.4174|TWO_SIDED|95.0|-5.63|2.34|||Mixed Models Analysis|||Month 36: Physical Functioning||2.34|-5.63|0.4174
71759427|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.44|STANDARD_ERROR_OF_MEAN|2.6||0.3486|TWO_SIDED|95.0|-7.54|2.66|||Mixed Models Analysis|||Month 36: Physical Functioning||2.66|-7.54|0.3486
71759428|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.52|STANDARD_ERROR_OF_MEAN|2.47||0.8335|TWO_SIDED|95.0|-4.33|5.37|||Mixed Models Analysis|||Month 36: Role Physical||5.37|-4.33|0.8335
71759429|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-2.0|STANDARD_ERROR_OF_MEAN|3.18||0.5291|TWO_SIDED|95.0|-8.24|4.24|||Mixed Models Analysis|||Month 36: Role Physical||4.24|-8.24|0.5291
71759430|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.09|STANDARD_ERROR_OF_MEAN|2.5||0.4033|TWO_SIDED|95.0|-2.82|7.0|||Mixed Models Analysis|||Month 36: Bodily Pain||7.00|-2.82|0.4033
71759431|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.38|STANDARD_ERROR_OF_MEAN|3.24||0.9078|TWO_SIDED|95.0|-6.74|5.99|||Mixed Models Analysis|||Month 36: Bodily Pain||5.99|-6.74|0.9078
71759432|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.77|STANDARD_ERROR_OF_MEAN|2.08||0.3947|TWO_SIDED|95.0|-2.31|5.86|||Mixed Models Analysis|||Month 36: General Health||5.86|-2.31|0.3947
71759433|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.97|STANDARD_ERROR_OF_MEAN|2.66||0.7165|TWO_SIDED|95.0|-4.26|6.2|||Mixed Models Analysis|||Month 36: General Health||6.20|-4.26|0.7165
71759434|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.44|STANDARD_ERROR_OF_MEAN|2.19||0.5112|TWO_SIDED|95.0|-2.87|5.75|||Mixed Models Analysis|||Month 36: Vitality||5.75|-2.87|0.5112
71759435|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.43|STANDARD_ERROR_OF_MEAN|2.86||0.1218|TWO_SIDED|95.0|-1.18|10.04|||Mixed Models Analysis|||Month 36: Vitality||10.04|-1.18|0.1218
71759436|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.47|STANDARD_ERROR_OF_MEAN|2.33||0.2895|TWO_SIDED|95.0|-2.11|7.05|||Mixed Models Analysis|||Month 36: Social Functioning||7.05|-2.11|0.2895
71759437|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.63|STANDARD_ERROR_OF_MEAN|3.03||0.8349|TWO_SIDED|95.0|-6.58|5.32|||Mixed Models Analysis|||Month 36: Social Functioning||5.32|-6.58|0.8349
71759438|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|5.62|STANDARD_ERROR_OF_MEAN|2.72||0.0393|TWO_SIDED|95.0|0.28|10.97|||Mixed Models Analysis|||Month 36: Role Emotional||10.97|0.28|0.0393
71759439|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.23|STANDARD_ERROR_OF_MEAN|3.52||0.7266|TWO_SIDED|95.0|-5.69|8.16|||Mixed Models Analysis|||Month 36: Role Emotional||8.16|-5.69|0.7266
71759440|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.63|STANDARD_ERROR_OF_MEAN|2.36||0.4916|TWO_SIDED|95.0|-3.02|6.27|||Mixed Models Analysis|||Month 36: Mental Health||6.27|-3.02|0.4916
71759441|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.38|STANDARD_ERROR_OF_MEAN|3.05||0.9008|TWO_SIDED|95.0|-5.62|6.38|||Mixed Models Analysis|||Month 36: Mental Health||6.38|-5.62|0.9008
71759442|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.2965|TWO_SIDED|95.0|-0.17|0.55|||Mixed Models Analysis|||Month 36: TR Scale Score||0.55|-0.17|0.2965
71759443|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.37|STANDARD_ERROR_OF_MEAN|0.24||0.1147|TWO_SIDED|95.0|-0.09|0.84|||Mixed Models Analysis|||Month 36: TR Scale Score||0.84|-0.09|0.1147
71759444|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.55|STANDARD_ERROR_OF_MEAN|1.97||0.7786|TWO_SIDED|95.0|-4.42|3.31|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.31|-4.42|0.7786
71759445|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.48|STANDARD_ERROR_OF_MEAN|2.53||0.5582|TWO_SIDED|95.0|-6.45|3.49|||Mixed Models Analysis|||Month 36: Physical Component Summary||3.49|-6.45|0.5582
71759446|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|4.05|STANDARD_ERROR_OF_MEAN|2.25||0.0727|TWO_SIDED|95.0|-0.37|8.47|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.47|-0.37|0.0727
71759447|NCT00658359|143020763|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|2.86|STANDARD_ERROR_OF_MEAN|2.91||0.3264|TWO_SIDED|95.0|-2.86|8.59|||Mixed Models Analysis|||Month 36: Mental Component Summary||8.59|-2.86|0.3264
71759448|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.11||0.3093|TWO_SIDED|95.0|-0.1|0.33|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.33|-0.10|0.3093
71759449|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.12|STANDARD_ERROR_OF_MEAN|0.12||0.3223|TWO_SIDED|95.0|-0.12|0.36|||Mixed Models Analysis|||Month 24 Limited Physical Capacity||0.36|-0.12|0.3223
71759450|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.08|STANDARD_ERROR_OF_MEAN|0.11||0.4858|TWO_SIDED|95.0|-0.14|0.3|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.30|-0.14|0.4858
71759451|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.11|STANDARD_ERROR_OF_MEAN|0.13||0.3679|TWO_SIDED|95.0|-0.13|0.36|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity||0.36|-0.13|0.3679
71759452|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.11||0.6416|TWO_SIDED|95.0|-0.27|0.17|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.17|-0.27|0.6416
71759453|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.1|STANDARD_ERROR_OF_MEAN|0.12||0.4241|TWO_SIDED|95.0|-0.34|0.14|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction||0.14|-0.34|0.4241
71759454|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.15|STANDARD_ERROR_OF_MEAN|0.12||0.2133|TWO_SIDED|95.0|-0.09|0.39|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.39|-0.09|0.2133
71759455|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.13||0.1918|TWO_SIDED|95.0|-0.09|0.44|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids||0.44|-0.09|0.1918
71759456|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.35|STANDARD_ERROR_OF_MEAN|0.1||0.001|TWO_SIDED|95.0|-0.55|-0.14|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.14|-0.55|0.0010
71759457|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.36|STANDARD_ERROR_OF_MEAN|0.12||0.002|TWO_SIDED|95.0|-0.59|-0.13|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair||-0.13|-0.59|0.0020
71759458|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.12||0.2012|TWO_SIDED|95.0|-0.08|0.4|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.40|-0.08|0.2012
71759459|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.02|STANDARD_ERROR_OF_MEAN|0.14||0.8986|TWO_SIDED|95.0|-0.25|0.29|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress||0.29|-0.25|0.8986
71759460|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.04|STANDARD_ERROR_OF_MEAN|0.08||0.6724|TWO_SIDED|95.0|-0.13|0.2|||Mixed Models Analysis|||Month 24 Global Score||0.20|-0.13|0.6724
71759461|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.01|STANDARD_ERROR_OF_MEAN|0.09||0.9297|TWO_SIDED|95.0|-0.18|0.19|||Mixed Models Analysis|||Month 24 Global Score||0.19|-0.18|0.9297
71759462|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.02|STANDARD_ERROR_OF_MEAN|0.13||0.8682|TWO_SIDED|95.0|-0.28|0.23|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.23|-0.28|0.8682
71759463|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.17|STANDARD_ERROR_OF_MEAN|0.18||0.3392|TWO_SIDED|95.0|-0.18|0.53|||Mixed Models Analysis|||Month 36 Limited Physical Capacity||0.53|-0.18|0.3392
71759464|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.13||0.6545|TWO_SIDED|95.0|-0.2|0.32|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.32|-0.20|0.6545
71759465|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.18|STANDARD_ERROR_OF_MEAN|0.19||0.3253|TWO_SIDED|95.0|-0.18|0.55|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity||0.55|-0.18|0.3253
71759466|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.0|STANDARD_ERROR_OF_MEAN|0.13||0.9698|TWO_SIDED|95.0|-0.26|0.25|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.25|-0.26|0.9698
71759467|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.19|STANDARD_ERROR_OF_MEAN|0.18||0.3065|TWO_SIDED|95.0|-0.17|0.54|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction||0.54|-0.17|0.3065
71759468|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7147|TWO_SIDED|95.0|-0.33|0.23|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.23|-0.33|0.7147
71759469|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.14|STANDARD_ERROR_OF_MEAN|0.2||0.4852|TWO_SIDED|95.0|-0.25|0.53|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids||0.53|-0.25|0.4852
71759470|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.21|STANDARD_ERROR_OF_MEAN|0.13||0.0888|TWO_SIDED|95.0|-0.46|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.46|0.0888
71759471|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.31|STANDARD_ERROR_OF_MEAN|0.17||0.0719|TWO_SIDED|95.0|-0.65|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair||0.03|-0.65|0.0719
71759472|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.14||0.7531|TWO_SIDED|95.0|-0.24|0.33|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.33|-0.24|0.7531
71759473|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.09|STANDARD_ERROR_OF_MEAN|0.2||0.6412|TWO_SIDED|95.0|-0.49|0.3|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress||0.30|-0.49|0.6412
71759474|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.01|STANDARD_ERROR_OF_MEAN|0.1||0.9186|TWO_SIDED|95.0|-0.2|0.18|||Mixed Models Analysis|||Month 36 Global Score||0.18|-0.20|0.9186
71759475|NCT00658359|143020764|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.06|STANDARD_ERROR_OF_MEAN|0.14||0.6629|TWO_SIDED|95.0|-0.21|0.33|||Mixed Models Analysis|||Month 36 Global Score||0.33|-0.21|0.6629
71759476|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.85|STANDARD_ERROR_OF_MEAN|1.72||0.2826|TWO_SIDED|95.0|-5.22|1.53|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||1.53|-5.22|0.2826
71759477|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.22|STANDARD_ERROR_OF_MEAN|1.97||0.5371|TWO_SIDED|95.0|-2.65|5.09|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score||5.09|-2.65|0.5371
71759478|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.62||0.7503|TWO_SIDED|95.0|-1.41|1.02|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||1.02|-1.41|0.7503
71759479|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.81|STANDARD_ERROR_OF_MEAN|0.72||0.261|TWO_SIDED|95.0|-0.6|2.21|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score||2.21|-0.60|0.2610
71759480|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.89|STANDARD_ERROR_OF_MEAN|0.98||0.3656|TWO_SIDED|95.0|-1.04|2.82|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||2.82|-1.04|0.3656
71759481|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.89|STANDARD_ERROR_OF_MEAN|1.15||0.4405|TWO_SIDED|95.0|-3.16|1.37|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score||1.37|-3.16|0.4405
71759482|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.6|STANDARD_ERROR_OF_MEAN|1.96||0.4135|TWO_SIDED|95.0|-5.45|2.25|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||2.25|-5.45|0.4135
71759483|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.96|STANDARD_ERROR_OF_MEAN|2.75||0.7272|TWO_SIDED|95.0|-4.45|6.37|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score||6.37|-4.45|0.7272
71759484|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.17|STANDARD_ERROR_OF_MEAN|0.71||0.8111|TWO_SIDED|95.0|-1.56|1.22|||Mixed Models Analysis|||Month 36 Non-Pain symptoms Converted Score||1.22|-1.56|0.8111
71759485|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|1.14|STANDARD_ERROR_OF_MEAN|1.02||0.2636|TWO_SIDED|95.0|-0.86|3.13|||Mixed Models Analysis|||Month 36 Non-Pain Symptoms Converted Score||3.13|-0.86|0.2636
71759486|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.45|STANDARD_ERROR_OF_MEAN|1.13||0.689|TWO_SIDED|95.0|-1.77|2.67|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.67|-1.77|0.6890
71759487|NCT00658359|143020765|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.13|STANDARD_ERROR_OF_MEAN|1.62||0.4853|TWO_SIDED|95.0|-4.31|2.05|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score||2.05|-4.31|0.4853
71759488|NCT02754440|143020768|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 5.0 × 10\^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71759489|NCT02754440|143020768|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 8.0 × 10\^6 for the double platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71759490|NCT02754440|143020768|OTHER|A procedure is a success if the subject's platelet product has a residual WBC count of \< 12.0 × 10\^6 for the triple platelet product group, or \< 5.0 × 10\^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|||0.968|
71759491|NCT02754440|143020769|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10\^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.957|STANDARD_ERROR_OF_MEAN|0.021|||ONE_SIDED|95.0|0.904|||||||Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.904|
71759492|NCT02754440|143020769|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10\^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71759493|NCT02754440|143020769|OTHER|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10\^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|STANDARD_ERROR_OF_MEAN|0.0|||ONE_SIDED|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|||0.968|
71759494|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|2.27|||||TWO_SIDED|95.0|-3.96|8.49||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.49|-3.96|
71759495|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|0.198|||||TWO_SIDED|95.0|-3.19|3.59||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-3.19|
71759496|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|1.55|||||TWO_SIDED|95.0|-2.25|5.35||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.35|-2.25|
71759497|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|20.0|||||TWO_SIDED|95.0|13.7|26.2||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||26.2|13.7|
71759498|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|6.19|||||TWO_SIDED|95.0|2.8|9.58||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.58|2.80|
71759499|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|11.7|||||TWO_SIDED|95.0|7.87|15.5||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||15.5|7.87|
71759500|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-13.9|||||TWO_SIDED|95.0|-18.9|-8.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-8.80|-18.9|
71759501|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-4.62|||||TWO_SIDED|95.0|-7.67|-1.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.56|-7.67|
71759502|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-8.43|||||TWO_SIDED|95.0|-11.5|-5.33||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.33|-11.5|
71759503|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|7.8|||||TWO_SIDED|95.0|2.72|12.9||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.9|2.72|
71759504|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|4.38|||||TWO_SIDED|95.0|1.3|7.46||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.46|1.30|
71759505|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|5.06|||||TWO_SIDED|95.0|1.93|8.18||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.18|1.93|
71759506|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|0.905|||||TWO_SIDED|95.0|-5.49|7.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.30|-5.49|
71759507|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-2.71|||||TWO_SIDED|95.0|-6.96|1.54||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.54|-6.96|
71759508|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|1.66|||||TWO_SIDED|95.0|-2.85|6.16||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.16|-2.85|
71759509|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|17.5|||||TWO_SIDED|95.0|11.2|23.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||23.8|11.2|
71759510|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|6.51|||||TWO_SIDED|95.0|2.32|10.7||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||10.7|2.32|
71759511|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|14.2|||||TWO_SIDED|95.0|9.75|18.7||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.7|9.75|
71759512|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-9.98|||||TWO_SIDED|95.0|-14.6|-5.34||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.34|-14.6|
71759513|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-3.46|||||TWO_SIDED|95.0|-7.22|0.297||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.297|-7.22|
71759514|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-8.16|||||TWO_SIDED|95.0|-11.6|-4.71||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.71|-11.6|
71759515|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|12.1|||||TWO_SIDED|95.0|7.39|16.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|7.39|
71759516|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|6.7|||||TWO_SIDED|95.0|2.91|10.5||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.5|2.91|
71759517|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|10.3|||||TWO_SIDED|95.0|6.88|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|6.88|
71759518|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-1.06|||||TWO_SIDED|95.0|-7.41|5.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.30|-7.41|
71759519|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|2.2|||||TWO_SIDED|95.0|-2.15|6.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.56|-2.15|
71759520|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|1.12|||||TWO_SIDED|95.0|-3.23|5.47||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.47|-3.23|
71759521|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|19.4|||||TWO_SIDED|95.0|13.2|25.6||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||25.6|13.2|
71759522|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|9.04|||||TWO_SIDED|95.0|4.78|13.3||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||13.3|4.78|
71759523|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|14.7|||||TWO_SIDED|95.0|10.4|18.9||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||18.9|10.4|
71759524|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-10.6|||||TWO_SIDED|95.0|-15.6|-5.52||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-5.52|-15.6|
71759525|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-4.25|||||TWO_SIDED|95.0|-9.26|0.764||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.764|-9.26|
71759526|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|-8.76|||||TWO_SIDED|95.0|-12.6|-4.87||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-4.87|-12.6|
71759527|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|12.3|||||TWO_SIDED|95.0|7.17|17.4||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||17.4|7.17|
71759528|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|5.95|||||TWO_SIDED|95.0|0.917|11.0||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.0|0.917|
71759529|NCT01263197|143020789|SUPERIORITY_OR_OTHER||LS mean difference|9.9|||||TWO_SIDED|95.0|5.98|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.8|5.98|
71759530|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|1.62|||||TWO_SIDED|95.0|-1.81|5.06||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.06|-1.81|
71759531|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|2.73|||||TWO_SIDED|95.0|-1.38|6.85||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||6.85|-1.38|
71759532|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|2.67|||||TWO_SIDED|95.0|-0.209|5.56||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.56|-0.209|
71759533|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|0.541|||||TWO_SIDED|95.0|-2.94|4.02||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.02|-2.94|
71759534|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|5.26|||||TWO_SIDED|95.0|1.09|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.43|1.09|
71759535|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|2.6|||||TWO_SIDED|95.0|-0.322|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|-0.322|
71759536|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-6.46|||||TWO_SIDED|95.0|-11.5|-1.41||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-1.41|-11.5|
71759537|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|0.171|||||TWO_SIDED|95.0|-5.21|5.56||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.56|-5.21|
71759538|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-3.09|||||TWO_SIDED|95.0|-6.73|0.557||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.557|-6.73|
71759539|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|1.46|||||TWO_SIDED|95.0|-3.61|6.53||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.53|-3.61|
71759540|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|11.4|||||TWO_SIDED|95.0|5.99|16.8||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||16.8|5.99|
71759541|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|7.15|||||TWO_SIDED|95.0|3.49|10.8||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.8|3.49|
71759542|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|0.0309|||||TWO_SIDED|95.0|-5.28|5.34||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.34|-5.28|
71759543|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-5.93|3.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.59|-5.93|
71759544|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-0.333|||||TWO_SIDED|95.0|-4.35|3.68||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.68|-4.35|
71759545|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-2.11|||||TWO_SIDED|95.0|-7.42|3.2||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.20|-7.42|
71759546|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|4.36|||||TWO_SIDED|95.0|-0.404|9.12||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||9.12|-0.404|
71759547|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-0.119|||||TWO_SIDED|95.0|-4.14|3.9||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||3.90|-4.14|
71759548|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-4.16|||||TWO_SIDED|95.0|-9.69|1.37||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.37|-9.69|
71759549|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-4.76|||||TWO_SIDED|95.0|-10.2|0.718||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.718|-10.2|
71759550|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-4.2|||||TWO_SIDED|95.0|-8.71|0.32||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.320|-8.71|
71759551|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|3.2|||||TWO_SIDED|95.0|-2.34|8.74||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.74|-2.34|
71759552|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|3.95|||||TWO_SIDED|95.0|-1.54|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.43|-1.54|
71759553|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|4.84|||||TWO_SIDED|95.0|0.319|9.37||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.37|0.319|
71759554|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|2.34|||||TWO_SIDED|95.0|-3.44|8.12||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||8.12|-3.44|
71759555|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|1.89|||||TWO_SIDED|95.0|-3.22|7.0||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||7.00|-3.22|
71759556|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|1.83|||||TWO_SIDED|95.0|-1.85|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||5.52|-1.85|
71759557|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|0.327|||||TWO_SIDED|95.0|-5.45|6.1||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.10|-5.45|
71759558|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|3.18|||||TWO_SIDED|95.0|-1.93|8.29||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||8.29|-1.93|
71759559|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|2.12|||||TWO_SIDED|95.0|-1.56|5.81||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.81|-1.56|
71759560|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-1.6|||||TWO_SIDED|95.0|-6.79|3.59||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.59|-6.79|
71759561|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-0.163|||||TWO_SIDED|95.0|-5.0|4.68||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||4.68|-5.00|
71759562|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|-0.829|||||TWO_SIDED|95.0|-5.2|3.54||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.54|-5.20|
71759563|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|1.95|||||TWO_SIDED|95.0|-3.27|7.17||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||7.17|-3.27|
71759564|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|3.71|||||TWO_SIDED|95.0|-1.17|8.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.59|-1.17|
71759565|NCT01263197|143020790|SUPERIORITY_OR_OTHER||LS mean difference|4.28|||||TWO_SIDED|95.0|-0.103|8.67||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.67|-0.103|
71759566|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-1.23|||||TWO_SIDED|95.0|-3.9|1.44||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.44|-3.90|
71759567|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|1.05|||||TWO_SIDED|95.0|-1.91|4.02||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.02|-1.91|
71759568|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-0.199|||||TWO_SIDED|95.0|-2.58|2.18||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.18|-2.58|
71759569|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|1.37|||||TWO_SIDED|95.0|-1.34|4.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.07|-1.34|
71759570|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|3.68|||||TWO_SIDED|95.0|0.674|6.69||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.69|0.674|
71759571|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|2.4|||||TWO_SIDED|95.0|-0.0178|4.81||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.81|-0.0178|
71759572|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-4.22|||||TWO_SIDED|95.0|-7.83|-0.619||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||-0.619|-7.83|
71759573|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|0.335|||||TWO_SIDED|95.0|-4.45|5.12||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.12|-4.45|
71759574|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-1.92|||||TWO_SIDED|95.0|-4.81|0.969||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||0.969|-4.81|
71759575|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|2.47|||||TWO_SIDED|95.0|-1.15|6.1||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||6.10|-1.15|
71759576|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|9.12|||||TWO_SIDED|95.0|4.3|13.9||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||13.9|4.30|
71759577|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|6.03|||||TWO_SIDED|95.0|3.12|8.94||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||8.94|3.12|
71759578|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-0.913|||||TWO_SIDED|95.0|-4.65|2.82||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.82|-4.65|
71759579|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-0.444|||||TWO_SIDED|95.0|-4.33|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||3.44|-4.33|
71759580|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|0.378|||||TWO_SIDED|95.0|-2.2|2.95||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.95|-2.20|
71759581|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|0.878|||||TWO_SIDED|95.0|-2.86|4.62||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||4.62|-2.86|
71759582|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|2.92|||||TWO_SIDED|95.0|-0.966|6.8||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||6.80|-0.966|
71759583|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|2.94|||||TWO_SIDED|95.0|0.366|5.52||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.52|0.366|
71759584|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-2.88|||||TWO_SIDED|95.0|-6.84|1.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.07|-6.84|
71759585|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-0.975|||||TWO_SIDED|95.0|-5.39|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||3.44|-5.39|
71759586|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-1.82|||||TWO_SIDED|95.0|-5.3|1.66||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||1.66|-5.30|
71759587|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|5.6|||||TWO_SIDED|95.0|1.63|9.56||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.56|1.63|
71759588|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|7.82|||||TWO_SIDED|95.0|3.39|12.3||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||12.3|3.39|
71759589|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|6.6|||||TWO_SIDED|95.0|3.11|10.1||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.1|3.11|
71759590|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|0.847|||||TWO_SIDED|95.0|-3.23|4.92||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||4.92|-3.23|
71759591|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-3.48|||||TWO_SIDED|95.0|-8.17|1.21||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||1.21|-8.17|
71759592|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-0.372|||||TWO_SIDED|95.0|-2.88|2.14||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.||2.14|-2.88|
71759593|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|1.9|||||TWO_SIDED|95.0|-2.17|5.98||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.98|-2.17|
71759594|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|1.07|||||TWO_SIDED|95.0|-3.62|5.76||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.76|-3.62|
71759595|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|3.03|||||TWO_SIDED|95.0|0.522|5.55||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.||5.55|0.522|
71759596|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|0.737|||||TWO_SIDED|95.0|-3.9|5.38||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||5.38|-3.90|
71759597|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-1.95|||||TWO_SIDED|95.0|-6.36|2.47||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.47|-6.36|
71759598|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|-1.17|||||TWO_SIDED|95.0|-4.79|2.45||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.||2.45|-4.79|
71759599|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|7.25|||||TWO_SIDED|95.0|2.59|11.9||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||11.9|2.59|
71759600|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|5.58|||||TWO_SIDED|95.0|1.13|10.0||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||10.0|1.13|
71759601|NCT01263197|143020791|SUPERIORITY_OR_OTHER||LS mean difference|5.53|||||TWO_SIDED|95.0|1.89|9.16||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.||9.16|1.89|
71759602|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.1974||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.1974
71759603|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
71759604|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
71759605|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.8263
71759606|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.7418||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented||||0.7418
71759607|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.2429||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.2429
71759608|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
71759609|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
71759610|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.9700
71759611|NCT01134055|143020793|SUPERIORITY_OR_OTHER|||||||0.7673||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented||||0.7673
71759612|NCT00847210|143020816|SUPERIORITY_OR_OTHER|||||||0.095||95.0||||There was no statistical significant difference (p-value \>0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.|ANOVA|||This study was not powered for any hypothesis testing. For Tmax, an analysis of variance (ANOVA) model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||||0.095
71759613|NCT00847210|143020817|SUPERIORITY_OR_OTHER||ratio of the central values for Cmax|1.21||||0.289|TWO_SIDED|90.0|0.897|1.63|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For natural logarithm of dose-normalized Cmax, an ANOVA model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. Site effect was tested in the model, and was not included in the final model if not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.630|0.897|0.289
71759614|NCT00847210|143020818|SUPERIORITY_OR_OTHER||Ratio of the dose-normalized AUC(0-tlqc)|1.158||||0.402|TWO_SIDED|90.0|0.864|1.551|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.551|0.864|0.402
71759615|NCT00847210|143020819|SUPERIORITY_OR_OTHER||Ratio of the central values for dose-nor|1.168||||0.388|TWO_SIDED|90.0|0.864|1.579|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P\>0.05). Pairwise comparisons between regimens were conducted.||1.579|0.864|0.388
71759616|NCT01721044|143020853|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71759617|NCT01721044|143020854|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71759618|NCT01721044|143020855|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71759619|NCT01721044|143020856|SUPERIORITY_OR_OTHER_LEGACY|||||||0.14|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.140
71759620|NCT01721044|143020857|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71759621|NCT01721044|143020858|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71759622|NCT01721044|143020859|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|||||||ANCOVA|||||||0.001
71759623|NCT01721044|143020860|SUPERIORITY_OR_OTHER_LEGACY|||||||0.723|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.723
71759624|NCT01721044|143020861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71759625|NCT01721044|143020861|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided \<=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.001
71759626|NCT01721044|143020862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
71759627|NCT01721044|143020862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
71759628|NCT01721044|143020862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
71759629|NCT01721044|143020862|SUPERIORITY_OR_OTHER_LEGACY|||||||0.015|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.015
71759630|NCT01721044|143020863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.002
71759631|NCT01721044|143020863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12||||0.001
71759632|NCT01721044|143020863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
71759633|NCT01721044|143020863|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24||||0.001
71759634|NCT01721044|143020864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759635|NCT01721044|143020864|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759636|NCT01721044|143020865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759637|NCT01721044|143020865|SUPERIORITY_OR_OTHER_LEGACY|||||||0.009|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.009
71759638|NCT01721044|143020866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759639|NCT01721044|143020866|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.003
71759640|NCT01721044|143020867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.012|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.012
71759641|NCT01721044|143020867|SUPERIORITY_OR_OTHER_LEGACY|||||||0.104|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||||||0.104
71759642|NCT01721044|143020868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.002
71759643|NCT01721044|143020868|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)|||||||0.004
71759644|NCT01721044|143020869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759645|NCT01721044|143020869|SUPERIORITY_OR_OTHER_LEGACY|||||||0.018|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.018
71759646|NCT01721044|143020870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759647|NCT01721044|143020870|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||||||0.001
71759648|NCT01721044|143020871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.005
71759649|NCT01721044|143020871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.004|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12||||0.004
71759650|NCT01721044|143020871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.002
71759651|NCT01721044|143020871|SUPERIORITY_OR_OTHER_LEGACY|||||||0.026|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24||||0.026
71759652|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.448|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.448
71759653|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||MCS Week 12||||0.058
71759654|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.446|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.446
71759655|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.401|TWO_SIDED||||||ANCOVA|||MCS Week 24||||0.401
71759656|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
71759657|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 12||||0.001
71759658|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
71759659|NCT01721044|143020872|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||PCS Week 24||||0.001
71759660|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
71759661|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm||||0.001
71759662|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.001
71759663|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.003|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm||||0.003
71759664|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
71759665|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm||||0.001
71759666|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.001
71759667|NCT01721044|143020873|SUPERIORITY_OR_OTHER_LEGACY|||||||0.002|TWO_SIDED|||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm||||0.002
71759668|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.362|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.362
71759669|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.17|TWO_SIDED||||||ANCOVA|||Absenteeism Week 12||||0.170
71759670|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.753|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.753
71759671|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.715|TWO_SIDED||||||ANCOVA|||Absenteeism Week 24||||0.715
71759672|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.077|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.077
71759673|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.058|TWO_SIDED||||||ANCOVA|||Presenteeism Week 12||||0.058
71759674|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.232|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.232
71759675|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.534|TWO_SIDED||||||ANCOVA|||Presenteeism Week 24||||0.534
71759676|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.079|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.079
71759677|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.07|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 12||||0.070
71759678|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.327|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.327
71759679|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.479|TWO_SIDED||||||ANCOVA|||Work Productivity Loss Week 24||||0.479
71759680|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.001
71759681|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.005|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 12||||0.005
71759682|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.001|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.001
71759683|NCT01721044|143020874|SUPERIORITY_OR_OTHER_LEGACY|||||||0.03|TWO_SIDED||||||ANCOVA|||Activity Impairment Week 24||||0.030
71759684|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
71759685|NCT04032093|143020885|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|16.1|24.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||24.7|16.1|
71759686|NCT04032093|143020885|OTHER||Geometric Mean Ratio|15.6|||||TWO_SIDED|95.0|11.9|20.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.4|11.9|
71759687|NCT04032093|143020885|OTHER||Geometric Mean Ratio|11.2|||||TWO_SIDED|95.0|8.7|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.5|8.7|
71759688|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.9|
71759689|NCT04032093|143020885|OTHER||Geometric Mean Ratio|24.2|||||TWO_SIDED|95.0|18.5|31.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||31.7|18.5|
71759690|NCT04032093|143020885|OTHER||Geometric Mean Ratio|20.4|||||TWO_SIDED|95.0|15.7|26.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||26.6|15.7|
71759691|NCT04032093|143020885|OTHER||Geometric Mean Ratio|13.6|||||TWO_SIDED|95.0|10.1|18.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.4|10.1|
71759692|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
71759693|NCT04032093|143020885|OTHER||Geometric Mean Ratio|19.8|||||TWO_SIDED|95.0|15.3|25.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||25.7|15.3|
71759694|NCT04032093|143020885|OTHER||Geometric Mean Ratio|20.0|||||TWO_SIDED|95.0|15.9|25.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||25.1|15.9|
71759695|NCT04032093|143020885|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|11.9|18.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||18.9|11.9|
71759696|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
71759697|NCT04032093|143020885|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|16.9|30.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||30.1|16.9|
71759698|NCT04032093|143020885|OTHER||Geometric Mean Ratio|22.5|||||TWO_SIDED|95.0|17.6|28.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||28.7|17.6|
71759699|NCT04032093|143020885|OTHER||Geometric Mean Ratio|16.8|||||TWO_SIDED|95.0|12.7|22.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||22.3|12.7|
71759700|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.2|0.8|
71759701|NCT04032093|143020885|OTHER||Geometric Mean Ratio|21.0|||||TWO_SIDED|95.0|16.6|26.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||26.5|16.6|
71759702|NCT04032093|143020885|OTHER||Geometric Mean Ratio|15.3|||||TWO_SIDED|95.0|11.6|20.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||20.1|11.6|
71759703|NCT04032093|143020885|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|8.1|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||14.0|8.1|
71759704|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.8|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.3|0.8|
71759705|NCT04032093|143020885|OTHER||Geometric Mean Ratio|26.6|||||TWO_SIDED|95.0|20.5|34.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||34.6|20.5|
71759706|NCT04032093|143020885|OTHER||Geometric Mean Ratio|18.0|||||TWO_SIDED|95.0|13.5|24.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||24.1|13.5|
71759707|NCT04032093|143020885|OTHER||Geometric Mean Ratio|13.5|||||TWO_SIDED|95.0|10.1|18.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||18.0|10.1|
71759708|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.0|||||TWO_SIDED|95.0|0.9|1.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: Before vaccination||1.3|0.9|
71759709|NCT04032093|143020885|OTHER||Geometric Mean Ratio|25.0|||||TWO_SIDED|95.0|19.9|31.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Weeks after vaccination||31.3|19.9|
71759710|NCT04032093|143020885|OTHER||Geometric Mean Ratio|18.1|||||TWO_SIDED|95.0|14.5|22.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after vaccination||22.8|14.5|
71759711|NCT04032093|143020885|OTHER||Geometric Mean Ratio|13.8|||||TWO_SIDED|95.0|10.8|17.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At delivery||17.5|10.8|
71759712|NCT04032093|143020885|OTHER||Geometric Mean Ratio|1.1|||||TWO_SIDED|95.0|0.9|1.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: Before vaccination||1.4|0.9|
71759713|NCT04032093|143020885|OTHER||Geometric Mean Ratio|34.7|||||TWO_SIDED|95.0|27.0|44.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Weeks after vaccination||44.4|27.0|
71759714|NCT04032093|143020885|OTHER||Geometric Mean Ratio|23.2|||||TWO_SIDED|95.0|18.2|29.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after vaccination||29.6|18.2|
71759715|NCT04032093|143020885|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.0|21.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At delivery||21.7|12.0|
71759716|NCT04032093|143020887|OTHER||Geometric Mean Ratio|10.7|||||TWO_SIDED|95.0|8.1|14.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.1|8.1|
71759717|NCT04032093|143020887|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|5.5|
71759718|NCT04032093|143020887|OTHER||Geometric Mean Ratio|15.8|||||TWO_SIDED|95.0|10.7|23.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||23.4|10.7|
71759719|NCT04032093|143020887|OTHER||Geometric Mean Ratio|5.6|||||TWO_SIDED|95.0|3.5|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.0|3.5|
71759720|NCT04032093|143020887|OTHER||Geometric Mean Ratio|6.6|||||TWO_SIDED|95.0|4.5|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||9.6|4.5|
71759721|NCT04032093|143020887|OTHER||Geometric Mean Ratio|14.9|||||TWO_SIDED|95.0|11.1|19.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||19.9|11.1|
71759722|NCT04032093|143020887|OTHER||Geometric Mean Ratio|11.0|||||TWO_SIDED|95.0|6.5|18.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.6|6.5|
71759723|NCT04032093|143020887|OTHER||Geometric Mean Ratio|19.2|||||TWO_SIDED|95.0|13.1|28.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||28.0|13.1|
71759724|NCT04032093|143020887|OTHER||Geometric Mean Ratio|6.9|||||TWO_SIDED|95.0|4.2|11.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||11.4|4.2|
71759725|NCT04032093|143020887|OTHER||Geometric Mean Ratio|7.3|||||TWO_SIDED|95.0|4.5|11.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||11.8|4.5|
71759726|NCT04032093|143020887|OTHER||Geometric Mean Ratio|10.8|||||TWO_SIDED|95.0|8.3|14.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.2|8.3|
71759727|NCT04032093|143020887|OTHER||Geometric Mean Ratio|9.7|||||TWO_SIDED|95.0|6.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.5|6.5|
71759728|NCT04032093|143020887|OTHER||Geometric Mean Ratio|10.6|||||TWO_SIDED|95.0|7.1|15.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.9|7.1|
71759729|NCT04032093|143020887|OTHER||Geometric Mean Ratio|8.2|||||TWO_SIDED|95.0|5.2|12.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||12.9|5.2|
71759730|NCT04032093|143020887|OTHER||Geometric Mean Ratio|4.8|||||TWO_SIDED|95.0|3.1|7.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||7.5|3.1|
71759731|NCT04032093|143020887|OTHER||Geometric Mean Ratio|14.0|||||TWO_SIDED|95.0|10.5|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||18.7|10.5|
71759732|NCT04032093|143020887|OTHER||Geometric Mean Ratio|11.8|||||TWO_SIDED|95.0|7.4|18.7|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||18.7|7.4|
71759733|NCT04032093|143020887|OTHER||Geometric Mean Ratio|11.9|||||TWO_SIDED|95.0|7.7|18.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||18.3|7.7|
71759734|NCT04032093|143020887|OTHER||Geometric Mean Ratio|8.9|||||TWO_SIDED|95.0|5.5|14.5|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.5|5.5|
71759735|NCT04032093|143020887|OTHER||Geometric Mean Ratio|5.4|||||TWO_SIDED|95.0|3.3|8.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||8.8|3.3|
71759736|NCT04032093|143020887|OTHER||Geometric Mean Ratio|9.5|||||TWO_SIDED|95.0|7.4|12.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||12.3|7.4|
71759737|NCT04032093|143020887|OTHER||Geometric Mean Ratio|8.4|||||TWO_SIDED|95.0|5.7|12.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||12.4|5.7|
71759738|NCT04032093|143020887|OTHER||Geometric Mean Ratio|9.9|||||TWO_SIDED|95.0|6.4|15.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||15.4|6.4|
71759739|NCT04032093|143020887|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.8|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||6.8|2.9|
71759740|NCT04032093|143020887|OTHER||Geometric Mean Ratio|4.0|||||TWO_SIDED|95.0|2.5|6.3|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.3|2.5|
71759741|NCT04032093|143020887|OTHER||Geometric Mean Ratio|12.4|||||TWO_SIDED|95.0|9.2|16.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||16.6|9.2|
71759742|NCT04032093|143020887|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|7.1|17.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||17.9|7.1|
71759743|NCT04032093|143020887|OTHER||Geometric Mean Ratio|10.4|||||TWO_SIDED|95.0|7.0|15.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||15.2|7.0|
71759744|NCT04032093|143020887|OTHER||Geometric Mean Ratio|5.7|||||TWO_SIDED|95.0|3.7|9.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||9.0|3.7|
71759745|NCT04032093|143020887|OTHER||Geometric Mean Ratio|4.3|||||TWO_SIDED|95.0|2.7|7.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||7.0|2.7|
71759746|NCT04032093|143020887|OTHER||Geometric Mean Ratio|11.3|||||TWO_SIDED|95.0|8.6|14.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: At birth||14.9|8.6|
71759747|NCT04032093|143020887|OTHER||Geometric Mean Ratio|10.2|||||TWO_SIDED|95.0|7.4|14.0|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 1 Month after birth||14.0|7.4|
71759748|NCT04032093|143020887|OTHER||Geometric Mean Ratio|15.0|||||TWO_SIDED|95.0|10.2|22.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 2 Months after birth||22.1|10.2|
71759749|NCT04032093|143020887|OTHER||Geometric Mean Ratio|6.1|||||TWO_SIDED|95.0|3.9|9.6|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 4 Months after birth||9.6|3.9|
71759750|NCT04032093|143020887|OTHER||Geometric Mean Ratio|4.5|||||TWO_SIDED|95.0|2.9|6.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|A 50%: 6 Months after birth||6.9|2.9|
71759751|NCT04032093|143020887|OTHER||Geometric Mean Ratio|16.2|||||TWO_SIDED|95.0|12.5|21.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: At birth||21.2|12.5|
71759752|NCT04032093|143020887|OTHER||Geometric Mean Ratio|12.8|||||TWO_SIDED|95.0|8.6|19.1|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 1 Month after birth||19.1|8.6|
71759753|NCT04032093|143020887|OTHER||Geometric Mean Ratio|17.7|||||TWO_SIDED|95.0|11.9|26.2|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 2 Months after birth||26.2|11.9|
71759754|NCT04032093|143020887|OTHER||Geometric Mean Ratio|9.0|||||TWO_SIDED|95.0|5.7|14.4|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 4 Months after birth||14.4|5.7|
71759755|NCT04032093|143020887|OTHER||Geometric Mean Ratio|6.2|||||TWO_SIDED|95.0|3.9|9.9|||||GMRs and 2-sided CIs were calculated by exponentiating the mean differences in the logarithms of the titers (RSV group - placebo group) and the corresponding CIs (CIs based on the Student t distribution).|B 50%: 6 Months after birth||9.9|3.9|
71759756|NCT02952820|143020899|SUPERIORITY||least squares geometric mean (LSGM)ratio|0.732|||<|0.0001|TWO_SIDED|95.0|0.636|0.843|||Mixed Models Analysis|||Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value \[MNAR/CCMV\]).||0.843|0.636|<.0001
71759757|NCT02952820|143020899|SUPERIORITY||LSGM ratio|0.701|||<|0.0001|TWO_SIDED|95.0|0.607|0.81|||Mixed Models Analysis|||Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.810|0.607|<.0001
71759758|NCT02952820|143020900|SUPERIORITY||LSGM ratio|0.781|||<|0.0001|TWO_SIDED|95.0|0.725|0.842|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.842|0.725|<.0001
71759759|NCT02952820|143020900|SUPERIORITY||LSGM ratio|0.752|||<|0.0001|TWO_SIDED|95.0|0.698|0.811|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.811|0.698|<.0001
71759760|NCT02952820|143020900|SUPERIORITY||LSGM ratio|0.81|||<|0.0001|TWO_SIDED|95.0|0.735|0.893|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.893|0.735|<.0001
71759761|NCT02952820|143020900|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.698|0.848|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.848|0.698|<.0001
71759762|NCT02952820|143020900|SUPERIORITY||LSGM ratio|0.778|||<|0.0001|TWO_SIDED|95.0|0.69|0.878|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.878|0.690|<.0001
71759763|NCT02952820|143020900|SUPERIORITY||LSGM ratio|0.77|||<|0.0001|TWO_SIDED|95.0|0.681|0.869|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||0.869|0.681|<.0001
71759764|NCT02952820|143020901|SUPERIORITY||LSM Difference|4.299|STANDARD_ERROR_OF_MEAN|0.848|<|0.0001|TWO_SIDED|95.0|2.638|5.961|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.961|2.638|<.0001
71759765|NCT02952820|143020901|SUPERIORITY||LSM Difference|5.793|STANDARD_ERROR_OF_MEAN|0.846|<|0.0001|TWO_SIDED|95.0|4.133|7.452|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||7.452|4.133|<.0001
71759766|NCT02952820|143020901|SUPERIORITY||LSM Difference|2.227|STANDARD_ERROR_OF_MEAN|0.979||0.023|TWO_SIDED|95.0|0.307|4.146|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||4.146|0.307|0.0230
71759767|NCT02952820|143020901|SUPERIORITY||LSM Difference|3.615|STANDARD_ERROR_OF_MEAN|1.01||0.0003|TWO_SIDED|95.0|1.635|5.595|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||5.595|1.635|0.0003
71759768|NCT02952820|143020901|SUPERIORITY||LSM Difference|4.222|STANDARD_ERROR_OF_MEAN|1.099||0.0001|TWO_SIDED|95.0|2.068|6.377|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.377|2.068|0.0001
71759769|NCT02952820|143020901|SUPERIORITY||LSM Difference|4.361|STANDARD_ERROR_OF_MEAN|1.092|<|0.0001|TWO_SIDED|95.0|2.22|6.501|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.501|2.220|<.0001
71759770|NCT02952820|143020901|SUPERIORITY||LSM Difference|4.549|STANDARD_ERROR_OF_MEAN|1.179||0.0001|TWO_SIDED|95.0|2.236|6.861|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.861|2.236|0.0001
71759771|NCT02952820|143020901|SUPERIORITY||LSM Difference|4.667|STANDARD_ERROR_OF_MEAN|1.17|<|0.0001|TWO_SIDED|95.0|2.373|6.96|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||6.960|2.373|<.0001
71759772|NCT02952820|143020902|SUPERIORITY||Least square mean (LSM) Difference|-14.328|STANDARD_ERROR_OF_MEAN|3.614|<|0.0001|TWO_SIDED|95.0|-21.411|-7.245|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.245|-21.411|<.0001
71759773|NCT02952820|143020902|SUPERIORITY||LSM Difference|-16.72|STANDARD_ERROR_OF_MEAN|3.619|<|0.0001|TWO_SIDED|95.0|-23.813|-9.626|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-9.626|-23.813|<.0001
71759774|NCT02952820|143020902|SUPERIORITY||LSM Difference|-5.514|STANDARD_ERROR_OF_MEAN|4.109||0.1796|TWO_SIDED|95.0|-13.568|2.54|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||2.540|-13.568|0.1796
71759775|NCT02952820|143020902|SUPERIORITY||LSM Difference|-7.005|STANDARD_ERROR_OF_MEAN|4.129||0.0898|TWO_SIDED|95.0|-15.098|1.088|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||1.088|-15.098|0.0898
71759776|NCT02952820|143020902|SUPERIORITY||LSM Difference|-13.424|STANDARD_ERROR_OF_MEAN|4.486||0.0028|TWO_SIDED|95.0|-22.218|-4.631|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-4.631|-22.218|0.0028
71759777|NCT02952820|143020902|SUPERIORITY||LSM Difference|-10.079|STANDARD_ERROR_OF_MEAN|4.578||0.0277|TWO_SIDED|95.0|-19.053|-1.104|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-1.104|-19.053|0.0277
71759778|NCT02952820|143020902|SUPERIORITY||LSM Difference|-17.474|STANDARD_ERROR_OF_MEAN|5.014||0.0005|TWO_SIDED|95.0|-27.306|-7.643|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-7.643|-27.306|0.0005
71759779|NCT02952820|143020902|SUPERIORITY||LSM Difference|-12.671|STANDARD_ERROR_OF_MEAN|4.951||0.0105|TWO_SIDED|95.0|-22.378|-2.964|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).||-2.964|-22.378|0.0105
71759780|NCT02952820|143020903|SUPERIORITY||LSM Difference|22.034|STANDARD_ERROR_OF_MEAN|4.354|<|0.0001|TWO_SIDED|95.0|13.488|30.579|||Mixed Models Analysis|||First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||30.579|13.488|<.0001
71759781|NCT02952820|143020903|SUPERIORITY||LSM Difference|31.796|STANDARD_ERROR_OF_MEAN|4.35|<|0.0001|TWO_SIDED|95.0|23.258|40.334|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||40.334|23.258|<.0001
71759782|NCT02952820|143020903|SUPERIORITY||LSM Difference|11.76|STANDARD_ERROR_OF_MEAN|5.269||0.0259|TWO_SIDED|95.0|1.418|22.102|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||22.102|1.418|0.0259
71759783|NCT02952820|143020903|SUPERIORITY||LSM Difference|22.131|STANDARD_ERROR_OF_MEAN|5.286|<|0.0001|TWO_SIDED|95.0|11.757|32.505|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||32.505|11.757|<.0001
71759784|NCT02952820|143020903|SUPERIORITY||LSM Difference|17.374|STANDARD_ERROR_OF_MEAN|5.906||0.0034|TWO_SIDED|95.0|5.781|28.968|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||28.968|5.781|0.0034
71759785|NCT02952820|143020903|SUPERIORITY||LSM Difference|21.686|STANDARD_ERROR_OF_MEAN|5.946||0.0003|TWO_SIDED|95.0|10.014|33.359|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||33.359|10.014|0.0003
71759786|NCT02952820|143020903|SUPERIORITY||LSM Difference|18.555|STANDARD_ERROR_OF_MEAN|6.324||0.0034|TWO_SIDED|95.0|6.14|30.969|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).||30.969|6.140|0.0034
71759787|NCT02952820|143020903|SUPERIORITY||LSM Difference|22.686|STANDARD_ERROR_OF_MEAN|6.392||0.0004|TWO_SIDED|95.0|10.137|35.234|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.||35.234|10.137|0.0004
71759788|NCT02952820|143020904|SUPERIORITY||Difference of percentage|13.67||||0.0004|TWO_SIDED|95.0|6.24|21.1|||Cochran-Mantel-Haenszel|||Sleep onset responders: Statistical analysis 1||21.10|6.24|0.0004
71759789|NCT02952820|143020904|SUPERIORITY||Difference of percentage|12.53||||0.0009|TWO_SIDED|95.0|5.2|19.86|||Cochran-Mantel-Haenszel|||Sleep Onset Responders: Statistical analysis 2||19.86|5.20|0.0009
71759790|NCT02952820|143020904|SUPERIORITY||Difference of percentage|14.65||||0.0002|TWO_SIDED|95.0|6.97|22.33|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 3||22.33|6.97|0.0002
71759791|NCT02952820|143020904|SUPERIORITY||Difference of percentage|9.82||||0.011|TWO_SIDED|95.0|2.29|17.35|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 4||17.35|2.29|0.0110
71759792|NCT02952820|143020906|SUPERIORITY||LSM Difference|-0.71|STANDARD_ERROR_OF_MEAN|0.287||0.0137|TWO_SIDED|95.0|-1.27|-0.15|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.15|-1.27|0.0137
71759793|NCT02952820|143020906|SUPERIORITY||LSM Difference|-0.94|STANDARD_ERROR_OF_MEAN|0.289||0.0011|TWO_SIDED|95.0|-1.51|-0.38|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.38|-1.51|0.0011
71759794|NCT02952820|143020906|SUPERIORITY||LSM Difference|-1.16|STANDARD_ERROR_OF_MEAN|0.302||0.0001|TWO_SIDED|95.0|-1.75|-0.57|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.57|-1.75|0.0001
71759795|NCT02952820|143020906|SUPERIORITY||LSM Difference|-1.36|STANDARD_ERROR_OF_MEAN|0.305|<|0.0001|TWO_SIDED|95.0|-1.96|-0.76|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.76|-1.96|<.0001
71759796|NCT02952820|143020906|SUPERIORITY||LSM Difference|-1.3|STANDARD_ERROR_OF_MEAN|0.302|<|0.0001|TWO_SIDED|95.0|-1.9|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.90|<.0001
71759797|NCT02952820|143020906|SUPERIORITY||LSM Difference|-1.32|STANDARD_ERROR_OF_MEAN|0.307|<|0.0001|TWO_SIDED|95.0|-1.92|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.71|-1.92|<.0001
71759798|NCT02952820|143020907|SUPERIORITY||LSM Difference|-1.66|STANDARD_ERROR_OF_MEAN|0.905||0.067|TWO_SIDED|95.0|-3.44|0.12|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||0.12|-3.44|0.0670
71759799|NCT02952820|143020907|SUPERIORITY||LSM Difference|-2.04|STANDARD_ERROR_OF_MEAN|0.913||0.0257|TWO_SIDED|95.0|-3.83|-0.25|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.25|-3.83|0.0257
71759800|NCT02952820|143020907|SUPERIORITY||LSM Difference|-2.18|STANDARD_ERROR_OF_MEAN|0.939||0.0206|TWO_SIDED|95.0|-4.02|-0.34|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.34|-4.02|0.0206
71759801|NCT02952820|143020907|SUPERIORITY||LSM Difference|-3.04|STANDARD_ERROR_OF_MEAN|0.95||0.0014|TWO_SIDED|95.0|-4.91|-1.18|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-1.18|-4.91|0.0014
71759802|NCT02952820|143020907|SUPERIORITY||LSM Difference|-2.5|STANDARD_ERROR_OF_MEAN|0.112||0.0134|TWO_SIDED|95.0|-4.48|-0.52|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.52|-4.48|0.0134
71759803|NCT02952820|143020907|SUPERIORITY||LSM Difference|-2.56|STANDARD_ERROR_OF_MEAN|1.026||0.0128|TWO_SIDED|95.0|-4.57|-0.54|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.||-0.54|-4.57|0.0128
71759804|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.205|STANDARD_ERROR_OF_MEAN|0.076||0.0067|TWO_SIDED|95.0|0.057|0.353|||Mixed Models Analysis|||First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.353|0.057|0.0067
71759805|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.171|STANDARD_ERROR_OF_MEAN|0.076||0.0237|TWO_SIDED|95.0|0.023|0.32|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.320|0.023|0.0237
71759806|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.077|STANDARD_ERROR_OF_MEAN|0.094||0.412|TWO_SIDED|95.0|-0.107|0.261|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.261|-0.107|0.4120
71759807|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.073|STANDARD_ERROR_OF_MEAN|0.094||0.4347|TWO_SIDED|95.0|-0.111|0.258|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.258|-0.111|0.4347
71759808|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.074|STANDARD_ERROR_OF_MEAN|0.109||0.4992|TWO_SIDED|95.0|-0.141|0.289|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.289|-0.141|0.4992
71759809|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.255|STANDARD_ERROR_OF_MEAN|0.11||0.0208|TWO_SIDED|95.0|0.039|0.471|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.471|0.039|0.0208
71759810|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.144|STANDARD_ERROR_OF_MEAN|0.119||0.2248|TWO_SIDED|95.0|-0.089|0.378|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.378|-0.089|0.2248
71759811|NCT02952820|143020908|SUPERIORITY||LSM Difference|0.261|STANDARD_ERROR_OF_MEAN|0.12||0.0298|TWO_SIDED|95.0|0.026|0.497|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.||0.497|0.026|0.0298
71759812|NCT03486834|143020924|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).|Incidence Rate Estimate|2.9|||||TWO_SIDED|95.0|1.6|4.9||||||||4.9|1.6|
71759813|NCT03486834|143020924|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
71759814|NCT03486834|143020924|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|42.4|||||TWO_SIDED|95.0|-13.5|71.1||||||||71.1|-13.5|
71759815|NCT03486834|143020925|OTHER||Difference in Percent|59.8|||||TWO_SIDED|95.0|55.8|63.5||||||||63.5|55.8|
71759816|NCT03486834|143020925|OTHER||Difference in Percent|57.6|||||TWO_SIDED|95.0|53.5|61.5||||||||61.5|53.5|
71759817|NCT03486834|143020926|OTHER||Difference in Percent|15.9|||||TWO_SIDED|95.0|11.7|20.1||||||||20.1|11.7|
71759818|NCT03486834|143020926|OTHER||Difference in Percent|17.4|||||TWO_SIDED|95.0|13.3|21.6||||||||21.6|13.3|
71759819|NCT03486834|143020927|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
71759820|NCT03486834|143020927|OTHER||Difference in Percent|0.0|||||TWO_SIDED|95.0|-0.5|0.5||||||||0.5|-0.5|
71759821|NCT03486834|143020928|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|6.7|||||TWO_SIDED|95.0|4.6|9.5||||||||9.5|4.6|
71759822|NCT03486834|143020928|OTHER|The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% CI.|Incidence Rate Estimate|5.1|||||TWO_SIDED|95.0|3.3|7.6||||||||7.6|3.3|
71759823|NCT03486834|143020928|OTHER|The statistical criterion for success requires the lower limit of the 95% CI of vaccine efficacy (VE) to be greater than 0%.|Vaccine Efficacy|-32.0|||||TWO_SIDED|95.0|-135.0|25.0||||||||25.0|-135.0|
71759824|NCT00638014|143020944|SUPERIORITY_OR_OTHER|||||||0.41||95.0|||||t-test, 2 sided|||||||0.41
71759825|NCT04546672|143020948|SUPERIORITY||Mean Difference (Final Values)|12.1||||0.58|TWO_SIDED|95.0|-31.1|55.4|||t-test, 2 sided|||||55.4|-31.1|0.58
71759826|NCT04546672|143020949|SUPERIORITY||Mean Difference (Final Values)|12.3|||<|0.001|TWO_SIDED|95.0|9.2|15.4|||t-test, 2 sided|||||15.4|9.2|<0.001
71759827|NCT04546672|143020950|SUPERIORITY||Odds Ratio (OR)|2.3||||0.087|TWO_SIDED|95.0|0.9|6.2|||Fisher Exact|||||6.2|0.9|0.087
71759828|NCT04546672|143020951|SUPERIORITY||Mean Difference (Final Values)|-6.9||||0.48|TWO_SIDED|95.0|-26.4|12.6|||t-test, 2 sided|||||12.6|-26.4|0.48
71759829|NCT04546672|143020952|SUPERIORITY||Mean Difference (Final Values)|16.7||||0.02|TWO_SIDED|95.0|2.3|31.1|||t-test, 2 sided|||||31.1|2.3|0.02
71759830|NCT04546672|143020953|SUPERIORITY||Mean Difference (Final Values)|3.0||||0.27|TWO_SIDED|95.0|-2.2|8.3|||t-test, 2 sided|||||8.3|-2.2|0.27
71759831|NCT00525161|143020959|SUPERIORITY_OR_OTHER||Clinical Response Rate at 3 months|0.0|||||TWO_SIDED||||||||Defined as complete response/partial response after 3 months of adding sorafenib to endocrine therapy|Based on known historical response rate to sorafenib of no better than 5-10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.||||
71759832|NCT00525161|143020960|SUPERIORITY_OR_OTHER||Median Progression Free Survival|6.1|||||TWO_SIDED|95.0|2.6|11.3||||||||11.3|2.6|
71759833|NCT03848728|143020976|SUPERIORITY||Risk Ratio (RR)|1.1||||0.0019|TWO_SIDED|95.0|1.03|1.16|||TMLE|||||1.16|1.03|0.0019
71759834|NCT02581410|143020994|NON_INFERIORITY|Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.|Adjusted GMC ratio|1.04|||||TWO_SIDED|95.0|0.92|1.17|||ANCOVA|||To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).||1.17|0.92|
71759835|NCT02000115|143021028|NON_INFERIORITY|8.0% non-inferiority margin|Difference in percentages between groups|1.5||||0.006|ONE_SIDED|95.0||5.7||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·0%)|We analysed the primary effectiveness endpoint in the intention-to- treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||5.7||0.006
71759836|NCT02000115|143021029|NON_INFERIORITY|8.5% non-inferiority margin|Difference in percentages between groups|4.2||||0.03|ONE_SIDED|95.0||8.1||p for non-inferiority|Kaplan-Meier estimates|Kaplan-Meier was used as the method for calculating the endpoint rate|Non-inferiority of the Portico valve to commercially available valves was shown if the upper bound of the 95% confidence interval (1-sided) for the difference in event rates between groups was less than the non-inferiority margin (8·5%)|We analysed the primary safety endpoint in the intention-to-treat (ITT) population using the Kaplan-Meier method to estimate event rates, the Greenwood method to calculate the standard error of the Kaplan-Meier estimates, and assuming an asymptotic normal distribution for event rate estimates.||8.1||0.03
71759837|NCT02000115|143021031|NON_INFERIORITY|non-inferiority margin of 4%|Difference in percentages between groups|0.4||||0.001|ONE_SIDED|95.0||2.3||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions.|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 4%, then non inferiority is demonstrated.|||2.3||0.001
71759838|NCT02000115|143021032|NON_INFERIORITY|non-inferiority margin of 10 points|Mean Difference (Final Values)|-0.5|||<|0.0001|ONE_SIDED|95.0|-3.5|||p for non-inferiority|two-sample t-test|The test statistic is based on two sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -10, then non inferiority is demonstrated.||||-3.5|<0.0001
71759839|NCT02000115|143021033|NON_INFERIORITY|non-inferiority margin of 6%|Difference in percentages between groups|5.6||||0.4|ONE_SIDED|95.0||8.5||p for non-inferiority|Farrington-Manning test|The test statistic is based on the Farrington-Manning method of testing non-inferiority of proportions|If the upper limit of the 95% confidence interval (1-sided) for the difference of proportions (Portico - CAV) is \< 6%, then non inferiority is demonstrated.|||8.5||0.40
71759840|NCT02000115|143021034|NON_INFERIORITY|non-inferiority margin on -36 meters|Mean Difference (Final Values)|3.5||||0.0003|ONE_SIDED|95.0|-15.4|||p for non-inferiority|two sample t-test|The test statistic is based on a two-sample t-test|If the lower limit of the 95% confidence interval (1-sided) for the difference of (Portico - CAV) is \> -36, then non inferiority is demonstrated.||||-15.4|0.0003
71759841|NCT02819011|143021057|SUPERIORITY|||||||0.04||||||priori threshold for statistical significance= 0.05|Mixed Models Analysis|||Repeated measures to compare changes in two groups from baseline to 6 months||||0.040
71759842|NCT02819011|143021058|SUPERIORITY|||||||0.005||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.005
71759843|NCT02819011|143021059|SUPERIORITY|||||||0.019||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months||||0.019
71759844|NCT02819011|143021061|SUPERIORITY|||||||0.572||||||priori threshold for statistical significance = 0.05|Generalized Estimating Equations|||Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.||||0.572
71759845|NCT02819011|143021062|SUPERIORITY|||||||0.65||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.650
71759846|NCT02819011|143021063|SUPERIORITY|||||||0.756||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.756
71759847|NCT02819011|143021066|SUPERIORITY|||||||0.769||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.769
71759848|NCT02819011|143021067|SUPERIORITY|||||||0.857||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.857
71759849|NCT02819011|143021068|SUPERIORITY|||||||0.829||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months||||0.829
71759850|NCT01646125|143021069|SUPERIORITY_OR_OTHER||Cox Proportional Hazard|0.76|||||TWO_SIDED|90.0|0.35|1.63||||||||1.63|0.35|
71759851|NCT02653417|143021078|SUPERIORITY||Mean Difference (Final Values)|-0.18|||||TWO_SIDED|||||||||Regimen 1 = 5 mg vs Regimen 4 = placebo||||
71759852|NCT02653417|143021078|SUPERIORITY||Mean Difference (Final Values)|0.08|||||TWO_SIDED|||||||||Regimen 2 = 10 mg vs Regimen 4 = placebo||||
71759853|NCT02653417|143021078|SUPERIORITY||Mean Difference (Final Values)|0.46|||||TWO_SIDED|||||||||Regimen 3 = 20 mg vs Regimen 4 = placebo||||
71759854|NCT01106690|143021101|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.62|STANDARD_ERROR_OF_MEAN|0.095|<|0.001|TWO_SIDED|95.0|-0.811|-0.437|||ANCOVA|||||-0.437|-0.811|<0.001
71759855|NCT01106690|143021101|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-0.76|STANDARD_ERROR_OF_MEAN|0.096|<|0.001|TWO_SIDED|95.0|-0.951|-0.575|||ANCOVA|||||-0.575|-0.951|<0.001
71759856|NCT01106690|143021102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|2.4||||0.007||95.0|1.26|4.57|||Regression, Logistic|||||4.57|1.26|0.007
71759857|NCT01106690|143021102|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|5.38|||<|0.001|TWO_SIDED|95.0|2.73|10.6|||Regression, Logistic|||||10.60|2.73|<0.001
71759858|NCT01106690|143021103|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-29.4|STANDARD_ERROR_OF_MEAN|3.857|<|0.001|TWO_SIDED|95.0|-36.96|-21.78|||ANCOVA|||||-21.78|-36.96|<0.001
71759859|NCT01106690|143021103|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-35.7|STANDARD_ERROR_OF_MEAN|3.861|<|0.001|TWO_SIDED|95.0|-43.3|-28.11|||ANCOVA|||||-28.11|-43.30|<0.001
71759860|NCT01106690|143021104|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|14.28|STANDARD_ERROR_OF_MEAN|2.521|<|0.001|TWO_SIDED|95.0|9.315|19.236|||ANCOVA|||||19.236|9.315|<0.001
71759861|NCT01106690|143021104|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|17.23|STANDARD_ERROR_OF_MEAN|2.509|<|0.001|TWO_SIDED|95.0|12.293|22.166|||ANCOVA|||||22.166|12.293|<0.001
71759862|NCT01106690|143021105|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-2.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-3.6|-1.8|||ANCOVA|||||-1.8|-3.6|<0.001
71759863|NCT01106690|143021105|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.001|TWO_SIDED|95.0|-4.6|-2.8|||ANCOVA|||||-2.8|-4.6|<0.001
71759864|NCT01106690|143021106|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-4.07|STANDARD_ERROR_OF_MEAN|1.43||0.005|TWO_SIDED|95.0|-6.879|-1.251|||ANCOVA|||||-1.251|-6.879|0.005
71759865|NCT01106690|143021106|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-3.46|STANDARD_ERROR_OF_MEAN|1.433||0.016|TWO_SIDED|95.0|-6.281|-0.643|||ANCOVA|||||-0.643|-6.281|0.016
71759866|NCT01106690|143021107|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-12.1|STANDARD_ERROR_OF_MEAN|5.7||0.034|TWO_SIDED|95.0|-12.1|-0.9|||ANCOVA|||||-0.9|-12.1|0.034
71759867|NCT01106690|143021107|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|-16.9|STANDARD_ERROR_OF_MEAN|5.7||0.003|TWO_SIDED|95.0|-28.1|-5.8|||ANCOVA|||||-5.8|-28.1|0.003
71759868|NCT01106690|143021108|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|4.8|STANDARD_ERROR_OF_MEAN|1.9||0.01|TWO_SIDED|95.0|1.2|8.5|||ANCOVA|||||8.5|1.2|0.010
71759869|NCT01106690|143021108|SUPERIORITY_OR_OTHER||Least-Squares Mean Difference|6.5|STANDARD_ERROR_OF_MEAN|1.9|<|0.001|TWO_SIDED|95.0|2.8|10.2|||ANCOVA|||||10.2|2.8|<0.001
71759870|NCT03219528|143021111|SUPERIORITY|||||||0.78|||||||Mixed Models Analysis|||Baseline||||0.78
71759871|NCT03219528|143021111|SUPERIORITY|||||||0.88|||||||Mixed Models Analysis|||Week 5||||0.88
71759872|NCT03219528|143021120|SUPERIORITY|||||||0.77|||||||Mixed Models Analysis|||Baseline||||0.77
71759873|NCT03219528|143021120|SUPERIORITY|||||||0.58|||||||Mixed Models Analysis|||Week 5||||0.58
71759874|NCT02120898|143021122|EQUIVALENCE|90% CI interval was -0.20 to +0.20 for therapeutic equivalence.|Percentage difference|-1.16||||0.0702|TWO_SIDED|90.0|-7.93|5.62|||Fisher Exact|||Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||5.62|-7.93|0.0702
71759875|NCT02120898|143021123|SUPERIORITY||Percentage difference|0.14||||0.0318|TWO_SIDED|90.0|-6.08|6.35||Threshold for significance at 0.05 level.|Fisher Exact|||Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.||6.35|-6.08|0.0318
71759876|NCT00043979|143021154|SUPERIORITY_OR_OTHER|||||||0.0003||||||7 participants who did not receive a transplant compared with 21 participants transplanted.|Kaplan-Meier|||||||.0003
71759877|NCT02919995|143021187|OTHER||Contrast ratio|1.038||||0.0196|TWO_SIDED|95.0|1.007|1.07|||ANCOVA|||||1.07|1.007|0.0196
71759878|NCT02919995|143021187|OTHER||Contrast ratio|1.024||||0.0802|TWO_SIDED|95.0|0.997|1.052|||ANCOVA|||||1.052|0.997|0.0802
71759879|NCT02919995|143021187|OTHER||Contrast ratio|0.986||||0.3487|TWO_SIDED|95.0|0.957|1.017|||ANCOVA|||||1.017|0.957|0.3487
71759880|NCT02919995|143021188|OTHER||Contrast ratio|1.072||||0.0043|TWO_SIDED|95.0|1.026|1.12|||ANCOVA|||||1.12|1.026|0.0043
71759881|NCT02919995|143021188|OTHER||Contrast ratio|1.055||||0.0109|TWO_SIDED|95.0|1.014|1.096|||ANCOVA|||||1.096|1.014|0.0109
71759882|NCT02919995|143021188|OTHER||Contrast ratio|0.984||||0.4306|TWO_SIDED|95.0|0.942|1.027|||ANCOVA|||||1.027|0.942|0.4306
71759883|NCT02919995|143021189|OTHER||Contrast ratio|1.065||||0.0064|TWO_SIDED|95.0|1.021|1.11|||ANCOVA|||||1.11|1.021|0.0064
71759884|NCT02919995|143021189|OTHER||Contrast ratio|1.049||||0.0149|TWO_SIDED|95.0|1.011|1.089|||ANCOVA|||||1.089|1.011|0.0149
71759885|NCT02919995|143021189|OTHER||Contrast ratio|0.945||||0.466|TWO_SIDED|95.0|0.945|1.027|||ANCOVA|||||1.027|0.945|0.466
71759886|NCT02919995|143021190|OTHER||Contrast ratio|1.061||||0.0093|TWO_SIDED|95.0|1.017|1.107|||ANCOVA|||||1.107|1.017|0.0093
71759887|NCT02919995|143021190|OTHER||Contrast ratio|1.042||||0.0333|TWO_SIDED|95.0|1.004|1.082|||ANCOVA|||||1.082|1.004|0.0333
71759888|NCT02919995|143021190|OTHER||Contrast ratio|0.982||||0.3693|TWO_SIDED|95.0|0.941|1.024|||ANCOVA|||||1.024|0.941|0.3693
71759889|NCT00473382|143021240|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|20.8|||<|0.0001|TWO_SIDED|95.0|11.4|30.2||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||30.2|11.4|<0.0001
71761219|NCT00611026|143024043|SUPERIORITY_OR_OTHER|||||||0.0093|TWO_SIDED|||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.||||0.0093
71759890|NCT00473382|143021240|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|33.3|||<|0.0001|TWO_SIDED|95.0|23.8|42.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||42.8|23.8|<0.0001
71759891|NCT00473382|143021241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.5|||<|0.0001|TWO_SIDED|95.0|5.4|11.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||11.5|5.4|<0.0001
71759892|NCT00473382|143021241|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|9.9|||<|0.0001|TWO_SIDED|95.0|6.4|13.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||13.3|6.4|<0.0001
71759893|NCT00473382|143021242|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|21.4||||0.0002|TWO_SIDED|95.0|10.8|31.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||31.9|10.8|0.0002
71759894|NCT00473382|143021242|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|27.1|||<|0.0001|TWO_SIDED|95.0|16.4|37.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||37.9|16.4|<0.0001
71759895|NCT00473382|143021243|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|7.1||||0.0119|TWO_SIDED|95.0|1.7|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||12.6|1.7|0.0119
71759896|NCT00473382|143021243|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|4.5||||0.1384|TWO_SIDED|95.0|-1.2|10.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||10.1|-1.2|0.1384
71761220|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.4|STANDARD_ERROR_OF_MEAN|0.2||0.0374|TWO_SIDED|95.0|-0.7|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.||-0.0|-0.7|0.0374
71759897|NCT00473382|143021244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|8.3||||0.0102|TWO_SIDED|95.0|2.0|14.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||14.6|2.0|0.0102
71759898|NCT00473382|143021244|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|11.2||||0.0005|TWO_SIDED|95.0|5.1|17.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||17.3|5.1|0.0005
71759899|NCT00473382|143021245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-111.8|||<|0.0001|TWO_SIDED|95.0|-151.6|-72.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-72.0|-151.6|<0.0001
71759900|NCT00473382|143021245|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-132.2|||<|0.0001|TWO_SIDED|95.0|-169.7|-94.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.||-94.8|-169.7|<0.0001
71759901|NCT00473382|143021246|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-4.3||||0.0853|TWO_SIDED|95.0|-9.3|0.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||0.8|-9.3|0.0853
71759902|NCT00473382|143021246|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|-5.8||||0.0073|TWO_SIDED|95.0|-9.8|-1.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.7|-9.8|0.0073
71759903|NCT00473382|143021247|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|14.0||||0.0002|TWO_SIDED|95.0|6.8|21.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||21.1|6.8|0.0002
71759904|NCT00473382|143021247|SUPERIORITY_OR_OTHER||Difference in percentage at Month 24|28.3|||<|0.0001|TWO_SIDED|95.0|20.2|36.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|||36.4|20.2|<0.0001
71759905|NCT00473382|143021248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.9|||<|0.0001|TWO_SIDED|95.0|-1.3|-0.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-0.5|-1.3|<0.0001
71759906|NCT00473382|143021248|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.3|||<|0.0001|TWO_SIDED|95.0|-1.6|-1.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, \>55 letters), baseline HbA1c (≤8%, \>8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.||-1.0|-1.6|<0.0001
71759907|NCT01189032|143021253|SUPERIORITY_OR_OTHER|||||||0.004||||||It's the p-value of linear trend. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.004
71759908|NCT01189032|143021253|SUPERIORITY_OR_OTHER|||||||0.006||||||It's the p-value of Saturated at 1% DE-089. It's adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).||||||0.006
71759909|NCT01821118|143021281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.984|STANDARD_ERROR_OF_MEAN|0.112|||TWO_SIDED|90.0|0.82|1.184|||||SE of mean is presented in log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.184|0.820|
71759910|NCT01821118|143021281|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.934|STANDARD_ERROR_OF_MEAN|0.075|||TWO_SIDED|90.0|0.825|1.056|||||SE of mean is presented in log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.056|0.825|
71759911|NCT01821118|143021282|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.852|STANDARD_ERROR_OF_MEAN|0.091|||TWO_SIDED|90.0|0.735|0.989|||||SE of mean is presented on log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||0.989|0.735|
71759912|NCT01821118|143021282|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.902|STANDARD_ERROR_OF_MEAN|0.082|||TWO_SIDED|90.0|0.788|1.031|||||SE of mean presented on log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.||1.031|0.788|
71759913|NCT01821118|143021283|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.005|STANDARD_ERROR_OF_MEAN|0.046|||TWO_SIDED|90.0|0.933|1.086|||||SE of mean presented on log e scale.|ROI1, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.086|0.933|
71759914|NCT01821118|143021283|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.049|STANDARD_ERROR_OF_MEAN|0.036|||TWO_SIDED|90.0|0.99|1.114|||||SE of mean presented on log e scale.|ROI1, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.114|0.990|
71759915|NCT01821118|143021283|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|0.998|STANDARD_ERROR_OF_MEAN|0.032|||TWO_SIDED|90.0|0.947|1.052|||||SE of mean presented on log e scale.|ROI2, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.052|0.947|
71759916|NCT01821118|143021283|SUPERIORITY_OR_OTHER||Geometric Mean Ratio|1.01|STANDARD_ERROR_OF_MEAN|0.031|||TWO_SIDED|90.0|0.96|1.063|||||SE of mean presented on log e scale.|ROI2, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.||1.063|0.960|
71759917|NCT01821118|143021284|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0602|STANDARD_ERROR_OF_MEAN|0.1281|||TWO_SIDED|90.0|-0.1576|0.2781||||||ROI1, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.2781|-0.1576|
71759918|NCT01821118|143021284|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0859|STANDARD_ERROR_OF_MEAN|0.1165|||TWO_SIDED|90.0|-0.2843|0.1124||||||ROI1, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1124|-0.2843|
71759919|NCT01821118|143021284|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0488|STANDARD_ERROR_OF_MEAN|0.0902|||TWO_SIDED|90.0|-0.2018|0.1042||||||ROI2, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.1042|-0.2018|
71759920|NCT01821118|143021284|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|-0.0888|STANDARD_ERROR_OF_MEAN|0.1061|||TWO_SIDED|90.0|-0.2689|0.0914||||||ROI2, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.||0.0914|-0.2689|
71759921|NCT01821118|143021285|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0464|STANDARD_ERROR_OF_MEAN|0.0395|||TWO_SIDED|90.0|-0.0207|0.1136||||||ROI1, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1136|-0.0207|
71759922|NCT01821118|143021285|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0737|STANDARD_ERROR_OF_MEAN|0.0383|||TWO_SIDED|90.0|0.0084|0.139||||||ROI1, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.1390|0.0084|
71759923|NCT01821118|143021285|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0219|STANDARD_ERROR_OF_MEAN|0.0337|||TWO_SIDED|90.0|-0.0352|0.079||||||ROI2, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0790|-0.0352|
71759924|NCT01821118|143021285|SUPERIORITY_OR_OTHER||Estimated Treatment Difference (log e)|0.0117|STANDARD_ERROR_OF_MEAN|0.034|||TWO_SIDED|90.0|-0.046|0.0694||||||ROI2, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.||0.0694|-0.0460|
71759925|NCT02691507|143021335|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759926|NCT02691507|143021335|SUPERIORITY_OR_OTHER|||||||0.002||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.002
71759927|NCT02691507|143021335|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.4|STANDARD_ERROR_OF_MEAN|0.795||0.616|TWO_SIDED|95.0|-1.196|1.998||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.998|-1.196|0.616
71759928|NCT02691507|143021336|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759929|NCT02691507|143021336|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759930|NCT02691507|143021336|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.85|STANDARD_ERROR_OF_MEAN|0.803||0.297|TWO_SIDED|95.0|-0.767|2.46||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.460|-0.767|0.297
71759931|NCT02691507|143021337|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759932|NCT02691507|143021337|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759933|NCT02691507|143021337|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.73|STANDARD_ERROR_OF_MEAN|0.846||0.394|TWO_SIDED|95.0|-0.973|2.426||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||2.426|-0.973|0.394
71759934|NCT02691507|143021338|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759935|NCT02691507|143021338|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759936|NCT02691507|143021338|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|0.28|STANDARD_ERROR_OF_MEAN|0.708||0.69|TWO_SIDED|95.0|-1.14|1.709||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.709|-1.140|0.690
71759937|NCT02691507|143021339|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759938|NCT02691507|143021339|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759939|NCT02691507|143021339|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.08|STANDARD_ERROR_OF_MEAN|0.735||0.914|TWO_SIDED|95.0|-1.556|1.397||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.397|-1.556|0.914
71759940|NCT02691507|143021340|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759941|NCT02691507|143021340|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759942|NCT02691507|143021340|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.24|STANDARD_ERROR_OF_MEAN|0.774||0.757|TWO_SIDED|95.0|-1.796|1.314||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.314|-1.796|0.757
71759943|NCT02691507|143021341|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759944|NCT02691507|143021341|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759945|NCT02691507|143021341|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.47|STANDARD_ERROR_OF_MEAN|0.798||0.556|TWO_SIDED|95.0|-2.075|1.129||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||1.129|-2.075|0.556
71759946|NCT02691507|143021342|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759947|NCT02691507|143021342|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759948|NCT02691507|143021342|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.27|STANDARD_ERROR_OF_MEAN|0.772||0.106|TWO_SIDED|95.0|-2.824|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||0.278|-2.824|0.106
71759949|NCT02691507|143021343|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759950|NCT02691507|143021343|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759951|NCT02691507|143021343|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|26.83|STANDARD_ERROR_OF_MEAN|6.681|<|0.001|TWO_SIDED|95.0|13.407|40.247||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||40.247|13.407|<0.001
71759952|NCT02691507|143021344|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759953|NCT02691507|143021344|SUPERIORITY_OR_OTHER|||||||0.004||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.004
71759954|NCT02691507|143021344|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|19.33|STANDARD_ERROR_OF_MEAN|3.996|<|0.001|TWO_SIDED|95.0|11.301|27.352||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||27.352|11.301|<0.001
71759955|NCT02691507|143021345|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759956|NCT02691507|143021345|SUPERIORITY_OR_OTHER|||||||0.009||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.009
71759957|NCT02691507|143021345|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|16.01|STANDARD_ERROR_OF_MEAN|4.072|<|0.001|TWO_SIDED|95.0|7.829|24.187||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.187|7.829|<0.001
71759958|NCT02691507|143021346|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759959|NCT02691507|143021346|SUPERIORITY_OR_OTHER|||||||0.003||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.003
71759960|NCT02691507|143021346|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|13.25|STANDARD_ERROR_OF_MEAN|3.764|<|0.001|TWO_SIDED|95.0|5.684|20.82||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||20.820|5.684|<0.001
71759961|NCT02691507|143021347|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759962|NCT02691507|143021347|SUPERIORITY_OR_OTHER|||||||0.049||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.049
71759963|NCT02691507|143021347|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.08|STANDARD_ERROR_OF_MEAN|4.138||0.001|TWO_SIDED|95.0|5.766|22.387||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||22.387|5.766|0.001
71759964|NCT02691507|143021348|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759965|NCT02691507|143021348|SUPERIORITY_OR_OTHER|||||||0.024||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.024
71759966|NCT02691507|143021348|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|14.26|STANDARD_ERROR_OF_MEAN|4.679||0.004|TWO_SIDED|95.0|4.862|23.66||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||23.660|4.862|0.004
71759967|NCT02691507|143021349|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759968|NCT02691507|143021349|SUPERIORITY_OR_OTHER|||||||0.015||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.015
71759969|NCT02691507|143021349|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.77|STANDARD_ERROR_OF_MEAN|4.222||0.004|TWO_SIDED|95.0|4.291|21.252||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||21.252|4.291|0.004
71759970|NCT02691507|143021350|SUPERIORITY_OR_OTHER||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||<0.001
71759971|NCT02691507|143021350|SUPERIORITY_OR_OTHER|||||||0.034||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.||||0.034
71759972|NCT02691507|143021350|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|12.71|STANDARD_ERROR_OF_MEAN|5.925||0.037|TWO_SIDED|95.0|0.805|24.621||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.||24.621|0.805|0.037
71759973|NCT04634253|143021405|SUPERIORITY||LS Mean|-0.88|STANDARD_ERROR_OF_MEAN|0.361||0.017|TWO_SIDED|95.0|-1.6|-0.16|||Mixed Models Analysis|||||-0.16|-1.60|0.017
71759974|NCT04634253|143021405|SUPERIORITY||LS Mean|-1.09|STANDARD_ERROR_OF_MEAN|0.32|<|0.001|TWO_SIDED|95.0|-1.73|-0.46|||Mixed Models Analysis|||||-0.46|-1.73|<0.001
71759975|NCT04634253|143021406|SUPERIORITY||Odds Ratio (OR)|1.0||||0.997|TWO_SIDED|95.0|0.29|3.44|||Regression, Logistic|||||3.44|0.29|0.997
71759976|NCT04634253|143021406|SUPERIORITY||Odds Ratio (OR)|3.4||||0.032|TWO_SIDED|95.0|1.11|10.4|||Regression, Logistic|||||10.40|1.11|0.032
71759977|NCT04634253|143021407|SUPERIORITY||Odds Ratio (OR)|0.29||||0.235|TWO_SIDED|95.0|0.04|2.25|||Regression, Logistic|||||2.25|0.04|0.235
71759978|NCT04634253|143021407|SUPERIORITY||Odds Ratio (OR)|1.37||||0.661|TWO_SIDED|95.0|0.33|5.61|||Regression, Logistic|||||5.61|0.33|0.661
71759979|NCT04634253|143021408|SUPERIORITY||Odds Ratio (OR)|0.97||||0.965|TWO_SIDED|95.0|0.22|4.28|||Regression, Logistic|||||4.28|0.22|0.965
71759980|NCT04634253|143021408|SUPERIORITY||Odds Ratio (OR)|2.91||||0.098|TWO_SIDED|95.0|0.82|10.33|||Regression, Logistic|||||10.33|0.82|0.098
71759981|NCT04634253|143021409|SUPERIORITY||LS Mean Difference|-11.26|STANDARD_ERROR_OF_MEAN|3.71||0.003|TWO_SIDED|95.0|-18.65|-3.87|||Mixed Models Analysis|||||-3.87|-18.65|0.003
71759982|NCT04634253|143021409|SUPERIORITY||LS Mean Difference|-13.1|STANDARD_ERROR_OF_MEAN|3.265|<|0.001|TWO_SIDED|95.0|-19.61|-6.6|||Mixed Models Analysis|||||-6.60|-19.61|<0.001
71759983|NCT04634253|143021410|SUPERIORITY||LS Mean Difference|-10.3|STANDARD_ERROR_OF_MEAN|3.782||0.008|TWO_SIDED|95.0|-17.83|-2.77|||Mixed Models Analysis|||||-2.77|-17.83|0.008
71759984|NCT04634253|143021410|SUPERIORITY||LS Mean Difference|-11.76|STANDARD_ERROR_OF_MEAN|3.282|<|0.001|TWO_SIDED|95.0|-18.29|-5.22|||Mixed Models Analysis|||||-5.22|-18.29|<0.001
71759985|NCT04634253|143021411|SUPERIORITY||LS Mean Difference|-2.93|STANDARD_ERROR_OF_MEAN|2.365||0.218|TWO_SIDED|95.0|-7.63|1.77|||ANCOVA|||Mental Component Score (MCS)||1.77|-7.63|0.218
71759986|NCT04634253|143021411|SUPERIORITY||LS Mean Difference|1.15|STANDARD_ERROR_OF_MEAN|2.065||0.578|TWO_SIDED|95.0|-2.95|5.26|||ANCOVA|||Mental Component Score (MCS)||5.26|-2.95|0.578
71759987|NCT04634253|143021411|SUPERIORITY||LS Mean Difference|2.02|STANDARD_ERROR_OF_MEAN|2.368||0.396|TWO_SIDED|95.0|-2.69|6.73|||ANCOVA|||Physical Component Score (PCS)||6.73|-2.69|0.396
71759988|NCT04634253|143021411|SUPERIORITY||LS Mean Difference|1.42|STANDARD_ERROR_OF_MEAN|2.057||0.493|TWO_SIDED|95.0|-2.67|5.5|||ANCOVA|||Physical Component Score (PCS)||5.50|-2.67|0.493
71759989|NCT01356277|143021426|SUPERIORITY||Odds Ratio (OR)|1.66||||0.006|TWO_SIDED|95.0|1.15|2.39|||Regression, Logistic|Unadjusted, ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|We estimated a sample size of 75 participants per group to have 85% power to detect a 20% difference in taking adherence between groups, using 2-sided tests and setting alpha at 0.05, assuming a common standard deviation of 40%. Targeted enrollment of 176 participants accounted for 15% drop-out. Only participants with electronic pillbox data could be included. For participants who withdrew or stopped using the pillbox, all available pillbox data were included.||2.39|1.15|0.006
71759990|NCT01356277|143021427|SUPERIORITY||Odds Ratio (OR)|1.74||||0.003|TWO_SIDED|95.0|1.21|2.5|||Regression, Logistic|Unadjusted ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|||2.50|1.21|0.003
71759991|NCT01356277|143021428|SUPERIORITY|||||||0.49|||||||Wilcoxon ranksum|||Null hypothesis was that there was no difference in the SD of tacrolimus trough levels between intervention and control.||||0.49
71759992|NCT01356277|143021429|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71759993|NCT01356277|143021430|SUPERIORITY|||||||0.15|||||||t-test, 2 sided|||||||0.15
71759994|NCT01356277|143021431|SUPERIORITY|||||||0.26|||||||Chi-squared|||Rates were compared between intervention and control groups using Chi square||||0.26
71759995|NCT01356277|143021432|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||.45
71759996|NCT00607373|143021433|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Fifty-one patients were enrolled to allow for patient withdrawals and potential exclusions from analysis sets.||||<0.001
71759997|NCT00607373|143021434|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided|||||||<0.001
71759998|NCT00607373|143021436|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided|||||||<0.001
71759999|NCT00607373|143021439|SUPERIORITY_OR_OTHER||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided|||||||<0.001
71760000|NCT00607373|143021441|SUPERIORITY_OR_OTHER|||||||0.013||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.013
71760001|NCT00607373|143021443|SUPERIORITY_OR_OTHER|||||||0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.001
71760002|NCT00607373|143021445|SUPERIORITY_OR_OTHER|||||||0.009||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.009
71760003|NCT00607373|143021447|SUPERIORITY_OR_OTHER||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||<0.001
71760004|NCT00607373|143021449|SUPERIORITY_OR_OTHER|||||||0.328||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided|||||||0.328
71760005|NCT00607373|143021451|SUPERIORITY_OR_OTHER|||||||0.035||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test|||||||0.035
71760006|NCT01724346|143021462|SUPERIORITY||Hazard Ratio (HR)|0.155|||<|0.0001|TWO_SIDED|95.0|0.11|0.22||P-value is from stratified log-rank test.|Log Rank|||||0.220|0.110|< 0.0001
71760007|NCT01724346|143021465|SUPERIORITY||Hazard Ratio (HR)|0.087|||<|0.0001|TWO_SIDED|95.0|0.054|0.141||P value is from stratified log-rank test.|Log Rank|||||0.141|0.054|< 0.0001
71760008|NCT01724346|143021466|SUPERIORITY||Rate ratio|2.496|||<|0.0001|TWO_SIDED|95.0|1.99|3.131||Rate ratio and p-value are based on Cochran-Mantel-Haenszel chi-square test stratified by Eastern Cooperative Oncology Group (ECOG; 0-1 vs 2) and Rai stage (0/I/II vs III/IV) at baseline.|Cochran-Mantel-Haenszel|||||3.131|1.990|< 0.0001
71760009|NCT02876601|143021469|SUPERIORITY|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||||||0.408
71760010|NCT02876601|143021470|SUPERIORITY|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||||||0.148
71760011|NCT02876601|143021471|SUPERIORITY|||||||0.039|||||||Wilcoxon (Mann-Whitney)|||||||0.039
71760012|NCT02876601|143021472|SUPERIORITY|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||||||0.642
71760013|NCT02876601|143021473|SUPERIORITY|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||||||0.026
71760014|NCT02876601|143021474|SUPERIORITY|||||||0.326|||||||Wilcoxon (Mann-Whitney)|||||||0.326
71760015|NCT02876601|143021475|SUPERIORITY|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||||||0.796
71760016|NCT02876601|143021476|SUPERIORITY|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||||||0.918
71760017|NCT02876601|143021477|SUPERIORITY|||||||0.877|||||||Wilcoxon (Mann-Whitney)|||||||0.877
71760018|NCT02876601|143021478|SUPERIORITY|||||||0.423|||||||Wilcoxon (Mann-Whitney)|||||||0.423
71760019|NCT02876601|143021479|SUPERIORITY|||||||0.938|||||||Wilcoxon (Mann-Whitney)|||||||0.938
71760020|NCT00256997|143021480|SUPERIORITY_OR_OTHER|||||||0.5498||||||P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale.|Cox proportional hazard model|||||||0.5498
71760021|NCT05006573|143021495|SUPERIORITY||Risk Ratio (RR)|1.14||||0.5911|TWO_SIDED|95.0|0.71|1.82|||negative binomial model|marginal standardization method|The rate ratio (Benralizumab/Placebo) and its 95% CI are estimated using a negative binomial model. The covariates include treatment arm, baseline blood eosinophil category, and number of exacerbations from previous year.|||1.82|0.71|0.5911
71760022|NCT05006573|143021496|SUPERIORITY||Hazard Ratio (HR)|1.12||||0.6677|TWO_SIDED|95.0|0.67|1.91|||Regression, Cox||The analysis is performed using cox proportional hazards model with covariates of treatment group, number of exacerbations in previous year and baseline eosinophil category.|||1.91|0.67|0.6677
71760023|NCT05232682|143021509|OTHER||F-test|2.41||||0.1183|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1183
71760024|NCT05232682|143021510|OTHER||F-test|0.07||||0.9308|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.9308
71760025|NCT05232682|143021511|OTHER||F-test|2.1||||0.1517|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.1517
71760026|NCT05232682|143021512|OTHER||F-test|0.14||||0.8747|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.8747
71760027|NCT05232682|143021513|OTHER||F-test|1.19||||0.3269|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3269
71760028|NCT05232682|143021514|OTHER||F-test|1.14||||0.3411|TWO_SIDED|||||Alpha value for significance set at p \< .05.|Mixed Models Analysis|||||||0.3411
71760029|NCT04953728|143021565|SUPERIORITY|||||||0.77306724|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.77306724
71760030|NCT04953728|143021565|SUPERIORITY|||||||0.24|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.24
71760031|NCT04953728|143021565|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.45
71760032|NCT04953728|143021565|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.13
71760033|NCT04953728|143021565|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum tolerance in mmHg of the rectum during Sham when compared to baseline||||0.14
71760034|NCT04953728|143021566|SUPERIORITY|||||||0.81019363|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to ST36 25Hz||||0.81019363
71760035|NCT04953728|143021566|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 100Hz||||0.18
71760036|NCT04953728|143021566|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to PC6 25Hz||||0.21
71760037|NCT04953728|143021566|SUPERIORITY|||||||0.58|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 100Hz when compared to Sham||||0.58
71760038|NCT04953728|143021566|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 100Hz||||0.18
71760039|NCT04953728|143021566|SUPERIORITY|||||||0.18|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to PC6 25Hz||||0.18
71760040|NCT04953728|143021566|SUPERIORITY|||||||0.78|||||||t-test, 2 sided|||Change in average maximum tolerance of ST36 25Hz when compared to sham||||0.78
71760041|NCT04953728|143021566|SUPERIORITY|||||||0.89|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to PC6 25Hz||||0.89
71760042|NCT04953728|143021566|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 100Hz when compared to sham||||0.05
71760043|NCT04953728|143021566|SUPERIORITY|||||||0.07|||||||t-test, 2 sided|||Change in average maximum tolerance of PC6 25Hz when compared to sham||||0.07
71760044|NCT04953728|143021567|SUPERIORITY|||||||0.00046998|||||||t-test, 2 sided|||ST36 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.00046998
71760045|NCT04953728|143021567|SUPERIORITY|||||||0.74369428|||||||t-test, 2 sided|||ST36 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.74369428
71760046|NCT04953728|143021567|SUPERIORITY|||||||0.09854383|||||||t-test, 2 sided|||PC6 100Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.09854383
71760047|NCT04953728|143021567|SUPERIORITY|||||||0.24872746|||||||t-test, 2 sided|||PC6 25Hz: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.24872746
71760048|NCT04953728|143021567|SUPERIORITY|||||||0.04828889|||||||t-test, 2 sided|||Sham: Difference of VAS sums between 15 and 50 mmHg between pre and post stimulation||||0.04828889
71760049|NCT04953728|143021568|SUPERIORITY|||||||0.02|||||||t-test, 1 sided|||ST36 100Hz compared to ST36 25Hz||||0.02
71760050|NCT04953728|143021568|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 100Hz||||0.11
71760051|NCT04953728|143021568|SUPERIORITY|||||||0.01|||||||t-test, 1 sided|||ST36 100Hz compared to PC6 25Hz||||0.01
71760052|NCT04953728|143021568|SUPERIORITY|||||||0.04|||||||t-test, 1 sided|||ST36 100Hz compared to Sham||||0.04
71760053|NCT04953728|143021568|SUPERIORITY|||||||0.11|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 100Hz||||0.11
71760054|NCT04953728|143021568|SUPERIORITY|||||||0.23|||||||t-test, 1 sided|||ST36 25Hz compared to PC6 25Hz||||0.23
71760055|NCT04953728|143021568|SUPERIORITY|||||||0.17|||||||t-test, 1 sided|||ST36 25Hz compared to Sham||||0.17
71760056|NCT04953728|143021568|SUPERIORITY|||||||0.15|||||||t-test, 1 sided|||PC6 100Hz compared to PC6 25Hz||||0.15
71760057|NCT04953728|143021568|SUPERIORITY|||||||0.43|||||||t-test, 1 sided|||PC6 100Hz compared to Sham||||0.43
71760058|NCT04953728|143021568|SUPERIORITY|||||||0.19|||||||t-test, 1 sided|||PC6 25Hz compared to Sham||||0.19
71760059|NCT04953728|143021569|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 100Hz when compared to baseline||||0.87
71760060|NCT04953728|143021569|SUPERIORITY|||||||0.13|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during ST36 25Hz when compared to baseline||||0.13
71760061|NCT04953728|143021569|SUPERIORITY|||||||0.17|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 100Hz when compared to baseline||||0.17
71760062|NCT04953728|143021569|SUPERIORITY|||||||0.88|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during PC6 25Hz when compared to baseline||||0.88
71760063|NCT04953728|143021569|SUPERIORITY|||||||0.14|||||||t-test, 2 sided|||Change in maximum volume in mL of the rectum during sham when compared to baseline||||0.14
71760064|NCT04953728|143021570|SUPERIORITY|||||||0.007|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 100Hz when compared to baseline||||0.007
71760065|NCT04953728|143021570|SUPERIORITY|||||||0.83|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during ST36 25Hz when compared to baseline||||0.83
71760066|NCT04953728|143021570|SUPERIORITY|||||||0.87|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 100Hz when compared to baseline||||0.87
71760067|NCT04953728|143021570|SUPERIORITY|||||||0.004|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during PC6 25Hz when compared to baseline||||0.004
71760068|NCT04953728|143021570|SUPERIORITY|||||||0.056|||||||t-test, 2 sided|||Change in first sensation in mmHg of the rectum during sham when compared to baseline||||0.056
71760069|NCT01136980|143021571|SUPERIORITY||||||<|0.028|||||||Chi-squared|||||||<0.028
71760070|NCT05462756|143021591|NON_INFERIORITY|The sample size provided \>99% statistical power to show noninferiority assuming a 0.4% noninferiority margin (NIM), in insulin efsitora doses compared to insulin glargine, in a 1:1 randomization, a standard deviation (SD) of 1.1%, and a dropout rate of 15%.|LS Mean Difference|-0.012|||||TWO_SIDED|95.0|-0.14|0.116||||||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|
71760071|NCT05462756|143021592|SUPERIORITY||LS Mean Difference|-0.012||||0.855|TWO_SIDED|95.0|-0.14|0.116|||ANCOVA|||Least Squares (LS) Mean was determined using ANCOVA model with Baseline + Country + Personal Use of CGM or FGM at Randomization + Treatment (Type III sum of squares) as variables. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed.||0.116|-0.140|0.855
71760072|NCT05462756|143021593|SUPERIORITY||Odds Ratio (OR)|1.11||||0.504|TWO_SIDED|95.0|0.81|1.52|||Chi-squared|||||1.52|0.81|0.504
71760073|NCT05462756|143021594|SUPERIORITY||Relative rate|0.67||||0.058|TWO_SIDED|95.0|0.44|1.01|||Negative binomial model||Relative rate is the ratio of the group means (Insulin Efsitora vs Insulin Glargine).|Group mean is determined by Negative Binomial Model using Number of episodes = Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.||1.01|0.44|0.058
71760074|NCT05462756|143021595|SUPERIORITY||LS Mean Difference|-4.29||||0.104|TWO_SIDED|95.0|-9.461|0.886|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||0.886|-9.461|0.104
71760075|NCT05462756|143021596|SUPERIORITY||LS Mean Difference|1.35||||0.337|TWO_SIDED|95.0|-1.404|4.101|||ANCOVA|||LS Mean was determined using ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||4.101|-1.404|0.337
71760076|NCT05462756|143021597|SUPERIORITY||LS Mean Difference|1.59||||0.104|TWO_SIDED|95.0|-0.327|3.508|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables. Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||3.508|-0.327|0.104
71760077|NCT05462756|143021598|SUPERIORITY||LS Mean Difference|-1.5||||0.304|TWO_SIDED|95.0|-4.358|1.36|||ANCOVA|||LS Mean was determined by ANCOVA model using Baseline + Country + Personal Use of CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares). Missing data at Baseline were imputed with multiple imputation with assumption of missing at random. Missing data at Week 22-Week 26 were imputed by return-to-baseline multiple imputations approach. A total of 100 datasets were imputed with one for each of the 100 datasets imputed at Baseline.||1.360|-4.358|0.304
71760078|NCT05462756|143021599|SUPERIORITY||LS Mean Difference|0.23||||0.523|TWO_SIDED|95.0|-0.48|0.95|||Mixed Models Analysis|||LS Mean was determined by MMRM model with BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Unstructured variance-covariance structure was used.||0.95|-0.48|0.523
71760079|NCT05462756|143021600|SUPERIORITY||LS Mean Difference|-35.04|||<|0.001|TWO_SIDED|95.0|-55.57|-14.5|||Mixed Models Analysis|||LS Mean was determined by Mixed Model Repeated Measures (MMRM) model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-14.50|-55.57|<0.001
71760080|NCT05462756|143021601|SUPERIORITY||LS Mean Difference|-7.55|||<|0.001|TWO_SIDED|95.0|-10.79|-4.3|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-4.30|-10.79|<0.001
71760081|NCT05462756|143021602|SUPERIORITY||LS Mean Difference|-73.5|||<|0.001|TWO_SIDED|95.0|-107.81|-39.2|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||-39.20|-107.81|<0.001
71760082|NCT05462756|143021603|SUPERIORITY||LS Mean Difference|3.53|||<|0.001|TWO_SIDED|95.0|1.49|5.58|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Hemoglobin A1c Stratum at Baseline + Country + Personal Use CGM or FGM at Randomization + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. Variance-covariance structure was set as compound symmetry.||5.58|1.49|<0.001
71760083|NCT05462756|143021604|SUPERIORITY||Mean Difference (Net)|1.11||||0.442|TWO_SIDED|95.0|0.85|1.44|||Negative binomial model|||Group mean was reported and determined by Negative binomial method using Baseline hypoglycemia rate + Hemoglobin A1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as variables.||1.44|0.85|0.442
71760084|NCT05462756|143021605|SUPERIORITY||LS Mean Difference|0.14||||0.543|TWO_SIDED|95.0|-0.32|0.6|||Mixed Models Analysis|||LS Mean was determined by MMRM model using BASELINE + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.||0.60|-0.32|0.543
71760085|NCT05462756|143021606|SUPERIORITY||LS Mean Difference|1.8||||0.099|TWO_SIDED|95.0|-0.3|4.0|||ANCOVA|||LS Mean was determined by ANCOVA model using Country + Personal Use CGM or FGM at Randomization + Hemoglobin A1c Stratum at Baseline + Treatment (Type III sum of squares) as variables.||4.0|-0.3|0.099
71760086|NCT00990704|143021611|SUPERIORITY_OR_OTHER||Difference between arms in percentage|13.6||||0.518|TWO_SIDED|95.0|-22.36|49.63|||Fisher Exact|||||49.63|-22.36|0.518
71760087|NCT04040933|143021619|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.86|TWO_SIDED||||||ANCOVA|||||||0.860
71760088|NCT04040933|143021619|OTHER|Change from Baseline in TEWL measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each baseline score within each treatment using paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.051|||||||ANCOVA|||||||0.051
71760089|NCT04040933|143021620|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.259|TWO_SIDED||||||ANCOVA|||||||0.259
71760090|NCT04040933|143021620|OTHER|Change from Baseline in Erythema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.451|||||||ANCOVA|||||||0.451
71760091|NCT04040933|143021621|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||>|0.999|TWO_SIDED||||||ANCOVA|||||||>0.999
71760092|NCT04040933|143021621|OTHER|Change from Baseline in Edema measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.739|||||||ANCOVA|||||||0.739
71760093|NCT04040933|143021622|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.|||||<|0.001|TWO_SIDED||||||ANCOVA|||||||<0.001
71760094|NCT04040933|143021622|OTHER|Change from Baseline in Composite Scar Score Measurements was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.053|||||||ANCOVA|||||||0.053
71760095|NCT04040933|143021623|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.666|TWO_SIDED||||||ANCOVA|||||||0.666
71760096|NCT04040933|143021623|OTHER|Change in Baseline in Painful Score with Arm Resting by Side was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.473|||||||ANCOVA|||||||0.473
71760097|NCT04040933|143021624|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.761|TWO_SIDED||||||ANCOVA|||||||0.761
71760098|NCT04040933|143021624|OTHER|Change from Baseline In Painful Score with Arm in Normal Motion was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.456|||||||ANCOVA|||||||0.456
71760099|NCT04040933|143021625|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.019|TWO_SIDED||||||ANCOVA|||||||0.019
71760100|NCT04040933|143021625|OTHER|Change from Baseline In Itchy Score was analyzed within-treatment and between-treatment. The within-treatment comparison was performed at each post-baseline time point by comparing the post-baseline scores with the baseline score within each treatment using the paired t-test. The between-treatment comparison was performed by comparing the change from baseline between treatments using a mixed effect analysis of covariance (ANCOVA) model.||||||0.325|||||||ANCOVA|||||||0.325
71761221|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.2||0.3161|TWO_SIDED|95.0|-0.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.||0.2|-0.5|0.3161
71760101|NCT04040933|143021626|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001|TWO_SIDED|||||no adjustments|Boot-strap sampling method|||All hypothesis tests was conducted at 0.05 level without adjustment of multiple comparisons||||<0.001
71760102|NCT04040933|143021626|OTHER|Time to complete healing was analyzed using a survival analysis method. The survival function (cumulative percentage of wounds healed at each time point) was estimated by the Kaplan-Meier method for each treatment separately. The median time to complete healing was derived from the estimated survival functions and be compared using the bootstrap re-sampling method.|||||<|0.001||||||no adjustments|Boot-strap sampling method|||||||<0.001
71760103|NCT00220636|143021670|SUPERIORITY_OR_OTHER||t statistic|4.7|||<|0.001|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.||||<.001
71760104|NCT00220636|143021672|SUPERIORITY_OR_OTHER||t statistic|-3.1||||0.009|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.||||.009
71760105|NCT00220636|143021673|SUPERIORITY_OR_OTHER||t statistic|3.1||||0.008|TWO_SIDED|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.||||.008
71760106|NCT02863419|143021688|NON_INFERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.1|||<|0.0001|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|<0.0001
71760107|NCT02863419|143021688|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1||||0.0645|TWO_SIDED|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||0.0|-0.3|0.0645
71760108|NCT02863419|143021688|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|TWO_SIDED|95.0|-1.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.9|-1.2|<0.0001
71760109|NCT02863419|143021688|NON_INFERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.0001|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|<0.0001
71760110|NCT02863419|143021688|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2||||0.0056|TWO_SIDED|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.1|-0.3|0.0056
71761222|NCT00611026|143024044|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.1817|TWO_SIDED|95.0|-0.5|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.||0.1|-0.5|0.1817
71760111|NCT02863419|143021688|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.2||||0.0001|TWO_SIDED|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-1.0|-1.4|0.0001
71760112|NCT02863419|143021689|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2||||0.0003|TWO_SIDED|95.0|-1.9|-0.6||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-0.6|-1.9|0.0003
71760113|NCT02863419|143021689|SUPERIORITY|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.8|||<|0.0001|TWO_SIDED|95.0|-4.7|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.||-3.0|-4.7|<0.0001
71760114|NCT02863419|143021689|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|TWO_SIDED|95.0|-2.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-0.9|-2.2|<0.0001
71760115|NCT02863419|143021689|SUPERIORITY|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-4.0|||<|0.0001|TWO_SIDED|95.0|-4.8|-3.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral sema 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.||-3.2|-4.8|<0.0001
71760116|NCT02863419|143021710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.17||||0.4915|TWO_SIDED|95.0|0.75|1.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||1.80|0.75|0.4915
71760117|NCT02863419|143021710|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.48||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.||0.48|0.21|<0.0001
71760118|NCT02863419|143021711|SUPERIORITY|This hypothesis was not controlled for multiplicity|Hazard Ratio (HR)|1.17||||0.6252|TWO_SIDED|95.0|0.62|2.22||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||2.22|0.62|0.6252
71760119|NCT02863419|143021711|SUPERIORITY|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15|||<|0.0001|TWO_SIDED|95.0|0.09|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.||0.26|0.09|<0.0001
71760120|NCT01995838|143021738|SUPERIORITY||LS Mean Difference|0.51||||0.0651|TWO_SIDED|95.0|-0.03|1.06|||ANCOVA|Baseline value and treatment as covariates.||||1.06|-0.03|0.0651
71760121|NCT01995838|143021738|SUPERIORITY||LS Mean Difference|0.13||||0.649|TWO_SIDED|95.0|-0.44|0.7|||ANCOVA|Baseline value and treatment as covariates.||||0.70|-0.44|0.6490
71760122|NCT01995838|143021738|SUPERIORITY||LS Mean Difference|0.43||||0.1059|TWO_SIDED|95.0|-0.09|0.94|||ANCOVA|Baseline value and treatment as covariates.||||0.94|-0.09|0.1059
71760123|NCT01995838|143021738|SUPERIORITY||LS Mean Difference|0.01||||0.9818|TWO_SIDED|95.0||0.55|||ANCOVA|Baseline value and treatment as covariates.||||0.55|-0. 54|0. 9818
71760124|NCT01995838|143021738|SUPERIORITY||LS Mean Difference|0.38||||0.1071|TWO_SIDED|95.0|-0.08|0.85|||ANCOVA|Baseline value and treatment as covariates.||||0.85|-0.08|0. 1071
71760125|NCT01995838|143021738|SUPERIORITY||LS Mean Difference|0.68||||0.0063|TWO_SIDED|95.0|0.19|1.17|||ANCOVA|Baseline value and treatment as covariates.||||1.17|0.19|0.0063
71760126|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|4.57||||0.0083|TWO_SIDED|95.0|1.19|7.94|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||7.94|1.19|0.0083
71760127|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|4.44||||0.0151|TWO_SIDED|95.0|0.86|8.01|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.01|0.86|0.0151
71760128|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|5.74||||0.0005|TWO_SIDED|95.0|2.54|8.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||8.93|2.54|0.0005
71760129|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|8.09|||<|0.0001|TWO_SIDED|95.0|4.73|11.45|||ANCOVA|||Days 1-2||11.45|4.73|<0.0001
71760130|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|10.06|||<|0.0001|TWO_SIDED|95.0|7.2|12.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||12.93|7.20|<0.0001
71760131|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|10.13|||<|0.0001|TWO_SIDED|95.0|7.18|13.08|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||13.08|7.18|<0.0001
71760132|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|0.34||||0.8505|TWO_SIDED|95.0|-3.22|3.9|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.90|-3.22|0.8505
71760133|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|3.94||||0.038|TWO_SIDED|95.0|0.22|7.66|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||7.66|0.22|0.0380
71760134|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|5.76||||0.0008|TWO_SIDED|95.0|2.4|9.12|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||9.12|2.40|0.0008
71760135|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|7.78|||<|0.0001|TWO_SIDED|95.0|4.24|11.32|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||11.32|4.24|<0.0001
71760136|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|7.89|||<|0.0001|TWO_SIDED|95.0|4.86|10.92|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||10.92|4.86|<0.0001
71760137|NCT01995838|143021739|SUPERIORITY||LS Mean Difference|8.87|||<|0.0001|TWO_SIDED|95.0|5.72|12.02|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||12.02|5.72|<0.0001
71760138|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.77||||0.1407|TWO_SIDED|95.0|0.54|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.09|0.54|0.1407
71760139|NCT01995838|143021740|SUPERIORITY|Days 1-2|Geometric Mean Ratio|0.55||||0.0018|TWO_SIDED|95.0|0.38|0.8|||ANCOVA|Baseline value and treatment as covariates.||||0.80|0.38|0.0018
71760140|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.6||||0.0025|TWO_SIDED|95.0|0.43|0.83|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.83|0.43|0.0025
71760141|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.54||||0.0006|TWO_SIDED|95.0|0.38|0.76|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.76|0.38|0.0006
71760142|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.52|||<|0.0001|TWO_SIDED|95.0|0.38|0.7|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||0.70|0.38|<0.0001
71760143|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.39|||<|0.0001|TWO_SIDED|95.0|0.29|0.54|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2:||0.54|0.29|<0.0001
71760144|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.73||||0.1158|TWO_SIDED|95.0|0.49|1.08|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||1.08|0.49|0.1158
71760145|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.49||||0.001|TWO_SIDED|95.0|0.33|0.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.75|0.33|0.0010
71760146|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.47|||<|0.0001|TWO_SIDED|95.0|0.32|0.69|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.69|0.32|<0.0001
71760147|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.32|||<|0.0001|TWO_SIDED|95.0|0.21|0.47|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.47|0.21|<0.0001
71760148|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.41|||<|0.0001|TWO_SIDED|95.0|0.29|0.57|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.57|0.29|<0.0001
71760149|NCT01995838|143021740|SUPERIORITY||Geometric Mean Ratio|0.34|||<|0.0001|TWO_SIDED|95.0|0.24|0.48|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.48|0.24|<0.0001
71760150|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-11.08||||0.105|TWO_SIDED|95.0|-24.48|2.33|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||2.33|-24.48|0.1050
71760151|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-2.29||||0.7501|TWO_SIDED|95.0|-16.46|11.87|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||11.87|-16.46|0.7501
71760152|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-11.26||||0.0818|TWO_SIDED|95.0|-23.94|1.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||1.43|-23.94|0.0818
71760153|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-19.81||||0.0038|TWO_SIDED|95.0|-33.18|-6.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-6.43|-33.18|0.0038
71760154|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-29.34|||<|0.0001|TWO_SIDED|95.0|-40.75|17.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||17.93|-40.75|<0.0001
71760155|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-25.84|||<|0.0001|TWO_SIDED|95.0|-37.59|-14.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2||-14.09|-37.59|<0.0001
71760156|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|0.4642||||0.4642|TWO_SIDED|95.0|-9.6|20.98|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||20.98|-9.60|0.4642
71760157|NCT01995838|143021741|SUPERIORITY|Baseline value and treatment as covariates.|LS Mean Difference|-2.31||||0.7754|TWO_SIDED|95.0|-18.27|13.64|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||13.64|-18.27|0.7754
71760158|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-10.69||||0.1461|TWO_SIDED|95.0|-25.14|3.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||3.75|-25.14|0.1461
71760159|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-14.73||||0.0581|TWO_SIDED|95.0|-29.97|0.51|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||0.51|-29.97|0.0581
71760160|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-20.8||||0.0019|TWO_SIDED|95.0|-33.86|-7.74|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.74|-33.86|0.0019
71760161|NCT01995838|143021741|SUPERIORITY||LS Mean Difference|-21.52||||0.002|TWO_SIDED|95.0|-35.12|-7.91|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15||-7.91|-35.12|0.0020
71760162|NCT01995838|143021745|SUPERIORITY||LS Mean Difference|-3.05||||0.1483|TWO_SIDED|95.0|-7.2|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.09|-7.20|0.1483
71760163|NCT01995838|143021745|SUPERIORITY||LS Mean Difference|-0.64||||0.772|TWO_SIDED|95.0|-4.96|3.69|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||3.69|-4.96|0.7720
71760164|NCT01995838|143021745|SUPERIORITY||LS Mean Difference|1.5||||0.4548|TWO_SIDED|95.0|-2.44|5.44|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.44|-2.44|0.4548
71760165|NCT01995838|143021745|SUPERIORITY||LS Mean Difference|-2.39||||0.253|TWO_SIDED|95.0|-6.51|1.72|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||1.72|-6.51|0.2530
71760166|NCT01995838|143021745|SUPERIORITY||LS Mean Difference|2.41||||0.1794|TWO_SIDED|95.0|-1.11|5.93|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||5.93|-1.11|0.1794
71760167|NCT01995838|143021745|SUPERIORITY||LS Mean Difference|0.94||||0.6148|TWO_SIDED|95.0|-2.74|4.63|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17||4.63|-2.74|0.6148
71760168|NCT00643162|143021787|OTHER||Mean Difference (Final Values)|2.3|STANDARD_DEVIATION|6.15||0.68|TWO_SIDED||||||t-test, 2 sided|||||||.68
71760169|NCT02284243|143021790|SUPERIORITY_OR_OTHER|||||||0.018|||||||ANCOVA|||||||0.0180
71760170|NCT02284243|143021791|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, and SPID 0-24|ANCOVA|||||||<0.05
71760171|NCT02284243|143021792|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to perceptible and meaningful pain relief|Log Rank|||||||<0.05
71760172|NCT02284243|143021793|SUPERIORITY_OR_OTHER||||||<|0.05||||||Applies to ≥30% and ≥50% reduction in pain|Cochran-Mantel-Haenszel|Test for general association stratified by site||||||<0.05
71760173|NCT02284243|143021795|SUPERIORITY_OR_OTHER|||||||0.0009|||||||Log Rank|||||||0.0009
71760174|NCT02284243|143021796|SUPERIORITY_OR_OTHER|||||||0.7718|||||||Cochran-Mantel-Haenszel|||||||0.7718
71760175|NCT00541385|143021817|OTHER|"Analysis of the PCR-corrected ACPR response rate on Day 28 for the PA group. Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is ≤90%.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is \>90%."|||||<|0.0001||||||The threshold for significance was ≤0.025.|Exact binomial test|||||||<0.0001
71760176|NCT00541385|143021817|NON_INFERIORITY|The secondary efficacy analysis tested the non-inferiority of PA compared to the AL group with regard to the PCR-corrected ACPR response rate on Day 28 using a 2-sided 95% confidence interval (Newcombe Wilson score method without continuity correction) and a 10% non-inferiority margin for the EE population. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% confidence interval for the difference in 28-day PCR-corrected ACPR was not lower than 10%.|ACPR percent difference|-1.2||||0.3728|TWO_SIDED|95.0|-3.6|2.1||If non-inferiority of PA was demonstrated, the p-value associated with a superiority test was calculated based on a 2-sided Chi-Square test. If the calculated p-value was \<0.05, then the superiority of PA over AL was statistically demonstrated.|Chi-squared|||"Null hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is inferior to the PCR-corrected ACPR response rate for the AL group.~Was tested versus the alternative:~Alternative hypothesis: The PCR-corrected ACPR response rate on Day 28 for the PA group is not inferior to the PCR-corrected ACPR response rate for the AL group."||2.1|-3.6|0.3728
71760177|NCT01499355|143021831|SUPERIORITY_OR_OTHER|||||||0.367||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world \[ROW\]) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.367
71760178|NCT01499355|143021831|SUPERIORITY_OR_OTHER|||||||0.283||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard|||||||0.283
71760179|NCT01499355|143021832|SUPERIORITY_OR_OTHER|||||||0.0486||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0486
71760180|NCT01499355|143021832|SUPERIORITY_OR_OTHER|||||||0.0668||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel|||||||0.0668
71760181|NCT01499355|143021833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.0628||||0.0456|TWO_SIDED|90.0|0.0081|0.4843||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||0.4843|0.0081|0.0456
71760182|NCT01499355|143021833|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|0.4344||||0.5455|TWO_SIDED|90.0|0.0996|1.8941||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic|||||1.8941|0.0996|0.5455
71760183|NCT01499355|143021833|SUPERIORITY_OR_OTHER|||||||0.0252|||||||Cochran-Mantel-Haenszel|||||||0.0252
71760184|NCT01499355|143021833|SUPERIORITY_OR_OTHER|||||||0.2876|||||||Cochran-Mantel-Haenszel|||||||0.2876
71760185|NCT01499355|143021836|SUPERIORITY_OR_OTHER|||||||0.863|||||||Regression, Cox|||||||0.863
71760186|NCT01499355|143021836|SUPERIORITY_OR_OTHER|||||||0.769|||||||Regression, Cox|||||||0.769
71760187|NCT01499355|143021836|SUPERIORITY_OR_OTHER|||||||0.907|||||||ANCOVA|||||||0.907
71760188|NCT01499355|143021836|SUPERIORITY_OR_OTHER|||||||0.996|||||||ANCOVA|||||||0.996
71760189|NCT02721966|143021865|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
71760190|NCT02721966|143021865|SUPERIORITY||Odds Ratio (OR)|3.83|||<|0.0001|TWO_SIDED|95.0|2.41|6.1|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||6.10|2.41|<.0001
71760191|NCT02721966|143021866|SUPERIORITY||Odds Ratio (OR)|4.37|||<|0.0001|TWO_SIDED|95.0|2.72|7.01|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"||7.01|2.72|<.0001
71760192|NCT02721966|143021867|SUPERIORITY||Odds Ratio (OR)|4.71|||<|0.0001|TWO_SIDED|95.0|2.67|8.33|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.67|<.0001
71760193|NCT02721966|143021867|SUPERIORITY||Odds Ratio (OR)|5.61|||<|0.0001|TWO_SIDED|95.0|3.2|9.84|||Regression, Logistic|95% confidence interval for odds ratio|||Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|9.84|3.20|<.0001
71760194|NCT02721966|143021868|SUPERIORITY||Odds Ratio (OR)|4.5|||<|0.0001|TWO_SIDED|95.0|2.43|8.33|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|8.33|2.43|<.0001
71760195|NCT02721966|143021868|SUPERIORITY||Odds Ratio (OR)|5.57|||<|0.0001|TWO_SIDED|95.0|3.04|10.21|||Regression, Logistic|95% confidence interval for odds ratio||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables|10.21|3.04|<.0001
71760196|NCT02721966|143021869|SUPERIORITY||LS Mean of Treatment Difference|-14.9|STANDARD_ERROR_OF_MEAN|2.62|<|0.0001|TWO_SIDED|95.0|-20.0|-9.7|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.0|<.0001
71760197|NCT02721966|143021869|SUPERIORITY||LS Mean of Treatment Difference|-12.9|STANDARD_ERROR_OF_MEAN|2.59|<|0.0001|TWO_SIDED|95.0|-18.0|-7.8|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-7.8|-18.0|<.0001
71760198|NCT02721966|143021870|SUPERIORITY||LS Mean of Treatment Difference|-15.1|STANDARD_ERROR_OF_MEAN|2.71|<|0.0001|TWO_SIDED|95.0|-20.4|-9.7|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.7|-20.4|<.0001
71760199|NCT02721966|143021870|SUPERIORITY||LS Mean of Treatment Difference|-15.0|STANDARD_ERROR_OF_MEAN|2.68|<|0.0001|TWO_SIDED|95.0|-20.3|-9.8|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-9.8|-20.3|<.0001
71760200|NCT02721966|143021871|SUPERIORITY||LS Mean of Treatment Difference|-0.5|STANDARD_ERROR_OF_MEAN|0.3||0.0971|TWO_SIDED|95.0|-1.1|0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline SPARCC index as continuous covariate.|0.1|-1.1|0.0971
71760201|NCT02721966|143021871|SUPERIORITY||LS Mean of Treatment Difference|-0.7|STANDARD_ERROR_OF_MEAN|0.3||0.0207|TWO_SIDED|95.0|-1.3|-0.1|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline measurement in VAS as continuous covariate|-0.1|-1.3|0.0207
71760202|NCT02721966|143021872|SUPERIORITY||LS Mean of Treatment Difference|-0.175|STANDARD_ERROR_OF_MEAN|0.0502||0.0005|TWO_SIDED|95.0|-0.273|-0.076|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.076|-0.273|0.0005
71760203|NCT02721966|143021872|SUPERIORITY||LS Mean of Treatment Difference|-0.234|STANDARD_ERROR_OF_MEAN|0.0497|<|0.0001|TWO_SIDED|95.0|-0.331|-0.136|||ANCOVA||||Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline HAQ-DI index as continuous covariate|-0.136|-0.331|<.0001
71760204|NCT02721966|143021873|SUPERIORITY||LS Mean of Treatment Difference|3.8|STANDARD_ERROR_OF_MEAN|1.01||0.0002|TWO_SIDED|95.0|1.8|5.7|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.7|1.8|0.0002
71760205|NCT02721966|143021873|SUPERIORITY||LS Mean of Treatment Difference|3.4|STANDARD_ERROR_OF_MEAN|0.99||0.0007|TWO_SIDED|95.0|1.4|5.3|||ANCOVA|||week 12|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group, visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline FACIT Fatigue© score as continuous covariate|5.3|1.4|0.0007
71760206|NCT02721966|143021874|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.41|<|0.0001|TWO_SIDED|95.0|-2.5|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.5|<.0001
71760207|NCT02721966|143021874|SUPERIORITY||LS Mean of Treatment Difference|-1.7|STANDARD_ERROR_OF_MEAN|0.4|<|0.0001|TWO_SIDED|95.0|-2.4|-0.9|||ANCOVA|||"Up to week 12, all participants in the group placebo AIN457 took placebo only"|Least squares (LS) mean, LS mean treatment difference, 95% confidence interval (CI) for treatment difference, and p-value are from MMRM (mixed model for repeated measures) with treatment group,visit, treatment\*visit, baseline\*visit and concomitant MTX intake status, as factors and baseline ASAS health index as continuous covariate.|-0.9|-2.4|<.0001
71760208|NCT02721966|143021875|SUPERIORITY||Odds Ratio (OR)|5.74|||<|0.0001|TWO_SIDED|95.0|3.31|9.95|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|9.95|3.31|<.0001
71760209|NCT02721966|143021875|SUPERIORITY||Odds Ratio (OR)|4.8|||<|0.0001|TWO_SIDED|95.0|2.83|8.16|||Regression, Logistic|95% confidence interval for odds ratio|||"Odds ratio, 95% CI for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage status (yes, no) as explanatory variables.~Missing ACR20 response variables were imputed by multiple imputation approach"|8.16|2.83|<.0001
71760210|NCT02157883|143021879|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|79.87|||||TWO_SIDED|90.0|73.15|87.21|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||87.21|73.15|
71760211|NCT02157883|143021880|NON_INFERIORITY_OR_EQUIVALENCE_LEGACY|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|124.17|||||TWO_SIDED|90.0|114.61|134.53|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||134.53|114.61|
71760212|NCT02157883|143021887|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|75.87|||||TWO_SIDED|90.0|64.18|89.69|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||89.69|64.18|
71760213|NCT02157883|143021888|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|108.25|||||TWO_SIDED|90.0|94.36|124.19|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||124.19|94.36|
71760214|NCT02157883|143021889|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|44.33|||||TWO_SIDED|90.0|39.94|49.21|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||49.21|39.94|
71760215|NCT02157883|143021890|SUPERIORITY_OR_OTHER_LEGACY||Geometric mean ratio|49.02|||||TWO_SIDED|90.0|43.7|54.99|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.||54.99|43.70|
71760216|NCT00888940|143021891|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.001
71760217|NCT00750438|143021901|SUPERIORITY|||||||0.972|||||||Regression, Linear|||||||0.972
71760218|NCT00750438|143021902|SUPERIORITY|||||||0.559|||||||t-test, 2 sided|||Baseline and 24 weeks||||0.559
71760219|NCT00750438|143021902|SUPERIORITY|||||||0.062|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.062
71760220|NCT00750438|143021902|SUPERIORITY|||||||0.099|||||||Regression, Linear|||||||0.099
71760221|NCT00750438|143021903|SUPERIORITY|||||||0.036|||||||Regression, Linear|||||||0.036
71760222|NCT00750438|143021904|SUPERIORITY|||||||0.001|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.001
71760223|NCT00750438|143021904|SUPERIORITY|||||||0.723|||||||t-test, 2 sided|||Baseline to 24 weeks||||0.723
71760224|NCT00750438|143021904|SUPERIORITY|||||||0.027|||||||Regression, Linear|||||||0.027
71760225|NCT00750438|143021905|SUPERIORITY|||||||0.372|||||||t-test, 2 sided|||||||0.372
71760226|NCT00750438|143021905|SUPERIORITY|||||||0.644|||||||t-test, 2 sided|||||||0.644
71760227|NCT00750438|143021905|SUPERIORITY|||||||0.549|||||||Regression, Linear|||||||0.549
71760228|NCT00354432|143021914|SUPERIORITY_OR_OTHER_LEGACY|||||||0.3455|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.||The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.||||.3455
71760229|NCT00354432|143021915|SUPERIORITY_OR_OTHER_LEGACY|||||||0.2081|TWO_SIDED|||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|||Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.||||0.2081
71761167|NCT00611026|143024036|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||<0.0001
71761168|NCT00611026|143024036|SUPERIORITY_OR_OTHER|||||||0.0228|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0228
71761169|NCT00611026|143024036|SUPERIORITY_OR_OTHER|||||||0.0072|TWO_SIDED|||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0072
71761170|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations \> 5%) a non-parametric analysis was to be conducted using Van Elteren's test stratified by baseline quartile of the diary variable analyzed."||||0.0020
71761171|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.0519|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0519
71761172|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.1503|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.1503
71761173|NCT00611026|143024037|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71761174|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.0002|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0002
71761175|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.013|TWO_SIDED||||||Van Elteren's|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0130
71761176|NCT00611026|143024037|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||<0.0001
71761177|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.0021|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0021
71761178|NCT00611026|143024037|SUPERIORITY_OR_OTHER|||||||0.0525|TWO_SIDED||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).||||0.0525
71760230|NCT01732718|143021923|SUPERIORITY|||||||0.51|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect||||||0.51
71760231|NCT01732718|143021924|SUPERIORITY|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||||||0.74
71760232|NCT01732718|143021926|SUPERIORITY|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||||||0.31
71760233|NCT01732718|143021928|SUPERIORITY|||||||0.57|||||||see comments for explanation|albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)||||||0.57
71760234|NCT01732718|143021932|SUPERIORITY|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||||||0.64
71760235|NCT01732718|143021933|SUPERIORITY|||||||0.1469|||||||t-test, 1 sided|||Comparison of the change in AMC||||0.1469
71760236|NCT01732718|143021933|SUPERIORITY|||||||0.2382|||||||t-test, 1 sided|||Comparison of the change in ALC||||0.2382
71760237|NCT01732718|143021933|SUPERIORITY|||||||0.5833|||||||t-test, 1 sided|||Comparison of the change in ANC||||0.5833
71760238|NCT01732718|143021936|SUPERIORITY|||||||0.5184|||||||Wilcoxon (Mann-Whitney)|||||||0.5184
71760239|NCT02223702|143021942|SUPERIORITY_OR_OTHER||||||<|0.01|||||||Friedman Test|All rows were compared to eachother||||||<0.01
71760240|NCT02223702|143021943|SUPERIORITY_OR_OTHER||||||<|0.01|||||||ANOVA|All rows were compared to eachother||||||<0.01
71760241|NCT00499616|143021959|OTHER||Log Rank Test Statistic|0.9841||||0.3212|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.||||.3212
71760242|NCT00499616|143021963|OTHER||Log-Rank Test Statistic|5.0049||||0.0253|TWO_SIDED|95.0|||||Log Rank|||The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.||||.0253
71760243|NCT00499616|143021964|OTHER|The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|Log Rank Test Statistic|2.6709||||0.1022|TWO_SIDED|95.0|||||Log Rank|||||||.1022
71760244|NCT00499616|143021965|OTHER||Chi-Square Test Statistic|9.9111||||0.0016|TWO_SIDED|95.0|||||Chi-squared|||The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.||||.0016
71760245|NCT00826462|143022001|OTHER||||||<|0.01|||||||linear generalized estimating equations||||A linear GEE regression model adjusted for the significant covariates at p \< 0.05 from the univariate GEE logistic regression models calculated for success|||<0.01
71760246|NCT00826462|143022001|OTHER||||||<|0.01|||||||linear generalized estimating equations|||||||<0.01
71760247|NCT00826462|143022005|OTHER||||||||||||||||||linear generalized estimating equations (GEE) regression model adjusted for significant covariates; between groups estimated odds ratio (OR) for no pain on two isometric movements using logistic GEE regression model adjusted for significant covariates; 99 % confidence intervals|||
71760248|NCT01166282|143022043|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-51.17|||=|0.039|TWO_SIDED|95.0|-99.69|-2.66|||ANCOVA|||||-2.66|-99.69|=0.039
71760249|NCT01166282|143022044|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.62|||=|0.382|TWO_SIDED|95.0|-5.32|2.08|||1-way ANOVA|||||2.08|-5.32|=0.382
71760250|NCT01166282|143022045|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-3.4|||=|0.209|TWO_SIDED|95.0|-8.78|1.97|||1-way ANOVA|||||1.97|-8.78|=0.209
71760251|NCT01166282|143022046|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|-1.12|||=|0.509|TWO_SIDED|95.0|-4.49|2.26|||1-way ANOVA|||||2.26|-4.49|=0.509
71760252|NCT01166282|143022047|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|11.0|||=|0.514|TWO_SIDED|95.0|-18.5|40.5|||Fisher Exact|||||40.5|-18.5|=0.514
71760253|NCT01166282|143022048|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|27.7|||=|0.111|TWO_SIDED|95.0|-2.0|57.5|||Fisher Exact|||||57.5|-2.0|=0.111
71760254|NCT01166282|143022049|SUPERIORITY_OR_OTHER_LEGACY||Mean Difference (Final Values)|34.8|||=|0.031|TWO_SIDED|95.0|8.1|61.6|||Fisher Exact|||||61.6|8.1|=0.031
71760255|NCT03511937|143022089|SUPERIORITY||Mean Difference (Final Values)|-31.4||||0.02|TWO_SIDED|95.0|-57.9|-5.0||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-5.0|-57.9|0.02
71760256|NCT03511937|143022090|SUPERIORITY||Mean Difference (Final Values)|-69.4||||0.55|TWO_SIDED|95.0|-295.5|156.6||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||156.6|-295.5|0.55
71760257|NCT03511937|143022091|SUPERIORITY||Mean Difference (Final Values)|-13.0||||0.006|TWO_SIDED|95.0|-23.0|-4.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||-4|-23|0.006
71760258|NCT03511937|143022092|SUPERIORITY||Mean Difference (Final Values)|-0.2||||0.01|TWO_SIDED|95.0|-0.4|-0.1||The a priori threshold for statistical significance was \< 0.05.|Negative binomial regression|Analyses controlled for overweight/obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||-0.1|-0.4|0.010
71760259|NCT03511937|143022093|SUPERIORITY||Mean Difference (Final Values)|0.2||||0.403|TWO_SIDED|95.0|-0.2|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for obesity status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust standard errors.||||0.5|-0.2|0.403
71760260|NCT03511937|143022094|SUPERIORITY||Mean Difference (Final Values)|0.4||||0.005|TWO_SIDED|95.0|0.1|0.8||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.8|0.1|0.005
71760261|NCT03511937|143022095|SUPERIORITY||Mean Difference (Final Values)|37.0|||<|0.001|TWO_SIDED|95.0|32.0|43.0||The a priori threshold for statistical significance was \< 0.05.|Regression, Logistic|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between treatment arms.|Analyses used logistic regression to calculate mean difference in predicted probability of purchasing a sugar-sweetened beverage.|||43|32|<0.001
71760262|NCT03511937|143022096|SUPERIORITY||Mean Difference (Final Values)|1.7|||<|0.001|TWO_SIDED|95.0|1.4|1.9||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.9|1.4|<0.001
71760263|NCT03511937|143022097|SUPERIORITY||Mean Difference (Final Values)|0.4|||<|0.001|TWO_SIDED|95.0|0.3|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.3|<0.001
71760264|NCT03511937|143022098|SUPERIORITY||Mean Difference (Final Values)|1.1|||<|0.001|TWO_SIDED|95.0|0.9|1.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.3|0.9|<0.001
71760265|NCT03511937|143022099|SUPERIORITY||Mean Difference (Final Values)|0.9|||<|0.001|TWO_SIDED|95.0|0.7|1.1||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||1.1|0.7|<0.001
71760266|NCT03511937|143022100|SUPERIORITY||Mean Difference (Final Values)|0.07||||0.055|TWO_SIDED|95.0|-0.001|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.001|0.055
71760267|NCT03511937|143022101|SUPERIORITY||Mean Difference (Final Values)|-0.1||||0.258|TWO_SIDED|95.0|-0.27|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.27|0.258
71760268|NCT03511937|143022102|SUPERIORITY||Mean Difference (Final Values)|-0.09||||0.416|TWO_SIDED|95.0|-0.3|0.13||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.13|-0.30|0.416
71760269|NCT03511937|143022103|SUPERIORITY||Mean Difference (Final Values)|0.05||||0.609|TWO_SIDED|95.0|-0.14|0.24||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.24|-0.14|0.609
71760270|NCT03511937|143022104|SUPERIORITY||Mean Difference (Final Values)|0.3||||0.002|TWO_SIDED|95.0|0.1|0.5||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.5|0.1|0.002
71760271|NCT03511937|143022105|SUPERIORITY||Mean Difference (Final Values)|2.1|||<|0.001|TWO_SIDED|95.0|1.8|2.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||2.3|1.8|<0.001
71760272|NCT03511937|143022106|SUPERIORITY||Mean Difference (Final Values)|-0.08||||0.311|TWO_SIDED|95.0|-0.23|0.07||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.07|-0.23|0.311
71760273|NCT03511937|143022107|SUPERIORITY||Mean Difference (Final Values)|-0.11||||0.253|TWO_SIDED|95.0|-0.3|0.08||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.08|-0.30|0.253
71760274|NCT03511937|143022108|SUPERIORITY||Mean Difference (Final Values)|-0.04||||0.658|TWO_SIDED|95.0|-0.22|0.14||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||0.14|-0.22|0.658
71760275|NCT03511937|143022109|SUPERIORITY||Mean Difference (Final Values)|-49.5||||0.661|TWO_SIDED|95.0|-271.3|172.3||The a priori threshold for statistical significance was \< 0.05.|Regression, Linear|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||172.3|-271.3|0.661
71760276|NCT03511937|143022110|SUPERIORITY||Mean Difference (Final Values)|12.5||||0.082|TWO_SIDED|95.0|-1.6|26.6||The a priori threshold for statistical significance was \< 0.05.|Two-part regression model with robust SE|Analyses controlled for overweight/obese status and Hispanic ethnicity, which were unbalanced between arms, and estimated Huber-White robust SEs.||||26.6|-1.6|0.082
71760277|NCT04308291|143022135|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|paired t-test||||||<0.0001
71760278|NCT01526733|143022147|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.15|||<|0.0001|TWO_SIDED|90.0|1.71|2.71||Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||2.71|1.71|<0.0001
71760279|NCT01526733|143022147|SUPERIORITY_OR_OTHER||Geometric Least Squares Mean Ratio|2.62|||<|0.0001|TWO_SIDED|90.0|2.08|3.29||Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||||3.29|2.08|<0.0001
71760280|NCT02395081|143022184|SUPERIORITY|||||||0.7||||||SBP wk 16-20|ANOVA|||||||0.70
71760281|NCT02395081|143022186|SUPERIORITY|||||||0.49|||||||Chi-squared|||||||0.49
71760282|NCT02395081|143022187|SUPERIORITY|||||||0.79|||||||Chi-squared|||||||0.79
71760283|NCT02395081|143022189|SUPERIORITY|||||||0.83|||||||Chi-squared|||||||0.83
71760284|NCT02395081|143022190|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71760285|NCT02395081|143022191|SUPERIORITY|||||||0.24|||||||ANOVA|||||||0.24
71760286|NCT02395081|143022192|SUPERIORITY|||||||0.39|||||||Chi-squared|||||||0.39
71760287|NCT02395081|143022193|SUPERIORITY|||||||0.89|||||||Chi-squared|||||||0.89
71760288|NCT02395081|143022194|SUPERIORITY|||||||0.95|||||||Chi-squared|||||||0.95
71760289|NCT01869764|143022206|OTHER|||||||0.93|||||||ANOVA|||||||0.93
71760290|NCT01869764|143022207|OTHER|||||||0.29|||||||ANOVA|||||||0.29
71760291|NCT02141204|143022240|NON_INFERIORITY|Lower limit (LL) of the two-sided 95% confidence interval (CI) for the ratio of anti-RV IgA antibody GMCs between HRV Liq Group over the HRV Lyo Group should be greater than or equal to (≥) 0.5.|GMC ratio|0.93|||||TWO_SIDED|95.0|0.65|1.34|||ANCOVA|95% CI for the adjusted GMC ratio and the logarithm of baseline concentration were used as fixed effects in this ANCOVA model.||Anti-RV IgA GMCs (non-inferiority): Non-inferiority comparison between GSK Biologicals' HRV liquid vaccine (HRV Liq Group) and GSK Biologicals' HRV lyophilized vaccine (HRV Lyo Group) in terms of geometric mean concentrations (GMCs) for anti-RV antibodies, one month after the administration of the second dose of study vaccine.||1.34|0.65|
71760292|NCT01958164|143022245|SUPERIORITY_OR_OTHER||Mean Difference (Net)|73.3|||||TWO_SIDED|95.0|23.3|89.3|||||Difference calculated as actilyse minus saline solution|||89.3|23.3|
71760293|NCT01958164|143022246|SUPERIORITY_OR_OTHER||Mean Difference (Net)|66.7|||||TWO_SIDED|95.0|20.7|90.3|||||Difference calculated as actilyse minus saline solution|||90.3|20.7|
71760294|NCT02963506|143022250|OTHER||Correlation statistic|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|||Statistic and p-value were calculated using a Cochran-Mantel-Haenszel test (test for non-zero correlation statistic) based on modified ridit scores and including geographic region and prior Tumor Necrosis Factor (TNF) inhibitor exposure as stratification factors.||||<0.001
71760295|NCT02963506|143022250|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|2.6|||=|0.04|TWO_SIDED|95.0|1.04|6.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior tumor necrosis factor (TNF) inhibitor exposure.||6.48|1.04|=0.040
71760296|NCT02963506|143022250|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|4.5|||=|0.001|TWO_SIDED|95.0|1.83|10.86||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||10.86|1.83|=0.001
71760297|NCT02963506|143022250|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.5|||<|0.001|TWO_SIDED|95.0|2.27|13.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||13.48|2.27|<0.001
71760298|NCT02963506|143022250|OTHER|The pairwise testing of each bimekizumab dose versus placebo accounted for multiplicity by using a fixed sequence testing procedure with each bimekizumab dose being tested sequentially from the highest dose to the lowest dose. If the sequential testing failed to reach significance at a significance level of alpha=0.05, then the pairwise testing continued and the comparison was seen as non-significant.|Odds Ratio (OR)|5.3|||<|0.001|TWO_SIDED|95.0|2.19|12.92||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||12.92|2.19|<0.001
71760299|NCT02963506|143022251|OTHER||LS Mean Difference vs placebo|-0.5|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-0.86|-0.24|||ANCOVA|||Least squares (LS) Mean, standard error, confidence interval and p-value were derived using the analysis of covariance (ANCOVA) model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.24|-0.86|<0.001
71760300|NCT02963506|143022251|OTHER||LS Mean Difference vs placebo|-1.2|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.47|-0.83|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.83|-1.47|<0.001
71760301|NCT02963506|143022251|OTHER||LS Mean Difference vs placebo|-1.0|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.35|-0.72|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.72|-1.35|<0.001
71760302|NCT02963506|143022251|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.16|<|0.001|TWO_SIDED|95.0|-1.45|-0.82|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.82|-1.45|<0.001
71760303|NCT02963506|143022252|OTHER||Odds Ratio (OR)|1.7|||=|0.163|TWO_SIDED|95.0|0.8|3.67||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||3.67|0.80|=0.163
71760304|NCT02963506|143022252|OTHER||Odds Ratio (OR)|3.9|||<|0.001|TWO_SIDED|95.0|1.84|8.48||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||8.48|1.84|<0.001
71760305|NCT02963506|143022252|OTHER||Odds Ratio (OR)|3.5|||=|0.001|TWO_SIDED|95.0|1.66|7.61||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||7.61|1.66|=0.001
71760306|NCT02963506|143022252|OTHER||Odds Ratio (OR)|6.5|||<|0.001|TWO_SIDED|95.0|2.92|14.28||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||14.28|2.92|<0.001
71760307|NCT02963506|143022253|OTHER||Odds Ratio (OR)|5.3|||=|0.003|TWO_SIDED|95.0|1.74|15.96||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||15.96|1.74|=0.003
71760308|NCT02963506|143022253|OTHER||Odds Ratio (OR)|11.9|||<|0.001|TWO_SIDED|95.0|4.03|35.38||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||35.38|4.03|<0.001
71760309|NCT02963506|143022253|OTHER||Odds Ratio (OR)|14.3|||<|0.001|TWO_SIDED|95.0|4.81|42.46||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||42.46|4.81|<0.001
71760310|NCT02963506|143022253|OTHER||Odds Ratio (OR)|14.9|||<|0.001|TWO_SIDED|95.0|5.02|44.27||The p-values were displayed as nominal p-values.|Regression, Logistic|||For differences in relation to placebo: Odds Ratio, confidence interval and p-value were derived from a logistic regression model including fixed effects for treatment, geographic region and prior TNF inhibitor exposure.||44.27|5.02|<0.001
71760311|NCT02963506|143022254|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.094|TWO_SIDED|95.0|-1.31|0.1|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.10|-1.31|=0.094
71760312|NCT02963506|143022254|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.34|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.34|<0.001
71760313|NCT02963506|143022254|OTHER||LS Mean Difference vs placebo|-1.6|STANDARD_ERROR_OF_MEAN|0.37|<|0.001|TWO_SIDED|95.0|-2.35|-0.91|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.91|-2.35|<0.001
71760314|NCT02963506|143022254|OTHER||LS Mean Difference vs placebo|-1.9|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.6|-1.18|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-1.18|-2.60|<0.001
71760315|NCT02963506|143022255|OTHER||LS Mean Difference vs placebo|-0.6|STANDARD_ERROR_OF_MEAN|0.36|=|0.075|TWO_SIDED|95.0|-1.35|0.07|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||0.07|-1.35|=0.075
71760316|NCT02963506|143022255|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.003|TWO_SIDED|95.0|-1.79|-0.37|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.37|-1.79|=0.003
71760317|NCT02963506|143022255|OTHER||LS Mean Difference vs placebo|-1.1|STANDARD_ERROR_OF_MEAN|0.36|=|0.002|TWO_SIDED|95.0|-1.84|-0.42|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.42|-1.84|=0.002
71760318|NCT02963506|143022255|OTHER||LS Mean Difference vs placebo|-1.5|STANDARD_ERROR_OF_MEAN|0.36|<|0.001|TWO_SIDED|95.0|-2.22|-0.81|||ANCOVA|||LS Mean, standard error, confidence interval and p-value were derived using the ANCOVA model with treatment, geographic region and prior TNF inhibitor exposure as fixed effects and the Baseline value as covariate.||-0.81|-2.22|<0.001
71760319|NCT01397968|143022259|SUPERIORITY||||||<|0.0001|||||||Wilcoxon rank sum|||||||<0.0001
71760320|NCT01397968|143022260|SUPERIORITY||||||<|0.0001|||||||Regression, Logistic|||||||<0.0001
71760321|NCT02970162|143022270|SUPERIORITY|||||||0.0004||||||LS means|Least square means|Fixed effects treatment and QMG at Baseline. Between-treatment difference in LS means (95% CI) -6.54 (-9.78, -3.29).||||||0.0004
71760322|NCT02970162|143022271|SUPERIORITY||LS means|2.95||||0.0003|TWO_SIDED|95.0|1.53|4.38||CFB for SGI score was modeled as the response, with fixed effects terms for treatment and SGI at Baseline|Fixed effects linear model|This statistical test applies to the change from baseline SGI scores to Day 4 values row.||||4.38|1.53|0.0003
71760323|NCT02970162|143022272|SUPERIORITY|||||||0.002|||||||Wilcoxon Rank Sum Test|||||||0.0020
71760324|NCT02970162|143022273|SUPERIORITY|||||||0.0112|||||||Fisher Exact|||||||0.0112
71760325|NCT04845568|143022299|SUPERIORITY||Mean Difference (Net)|1.13|STANDARD_ERROR_OF_MEAN|2.08||0.592|TWO_SIDED|95.0|-3.16|5.43||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for physical activity does not differ between conditions.||5.43|-3.16|0.592
71760326|NCT04845568|143022299|SUPERIORITY||Mean Difference (Net)|-1.19|STANDARD_ERROR_OF_MEAN|1.56||0.453|TWO_SIDED|95.0|-4.39|2.02||A priori threshold for statistical significance was set at p\<0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Self-Efficacy for Healthy Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in self-efficacy for healthy eating does not differ between conditions.||2.02|-4.39|0.453
71760327|NCT04845568|143022300|SUPERIORITY||Mean Difference (Net)|0.275|STANDARD_ERROR_OF_MEAN|0.3||0.368|TWO_SIDED|95.0|-0.342|0.892||A priori threshold for statistical significance set at p\< 0.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness to Change Child's Eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in readiness for healthy eating does not differ between conditions.||.892|-.342|.368
71760328|NCT04845568|143022300|SUPERIORITY||Mean Difference (Net)|0.126|STANDARD_ERROR_OF_MEAN|0.34||0.714|TWO_SIDED|95.0|-0.575|0.827||A priori threshold for statistical significance set at p\< .05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in Caregiver Readiness for Physical Activity. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions to help child improve physical activity from baseline to two-week follow up does not differ between conditions.||.827|-.575|.714
71760329|NCT04845568|143022301|SUPERIORITY||Mean Difference (Net)|-0.522|STANDARD_ERROR_OF_MEAN|1.88||0.783|TWO_SIDED|95.0|-4.39|3.34||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child attitudes toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child attitudes toward healthy eating from baseline to post-intervention does not differ between conditions.||3.34|-4.39|.783
71760330|NCT04845568|143022301|SUPERIORITY||Mean Difference (Net)|-1.99|STANDARD_ERROR_OF_MEAN|1.97||0.323|TWO_SIDED|95.0|-6.05|2.07||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intentions toward healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in child intentions toward healthy eating from baseline to post-intervention does not differ between conditions.||2.07|-6.05|.323
71760331|NCT04845568|143022301|SUPERIORITY||Mean Difference (Net)|2.11|STANDARD_ERROR_OF_MEAN|1.89||0.276|TWO_SIDED|95.0|-1.79|6.01||A priori threshold for statistical significance is set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in caregiver intentions toward helping their child engage in healthy eating. It is an independent samples t test. It is testing the null hypothesis that the mean change in caregiver intentions from baseline to post-intervention does not differ between conditions.||6.01|-1.79|.276
71760332|NCT04845568|143022302|SUPERIORITY||Mean Difference (Net)|0.247|STANDARD_ERROR_OF_MEAN|0.4||0.547|TWO_SIDED|95.0|-0.59|1.08||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fruits. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fruit servings per week from baseline to two-week follow up does not differ between conditions.||1.08|-.59|.547
71760333|NCT04845568|143022302|SUPERIORITY||Mean Difference (Net)|-0.005|STANDARD_ERROR_OF_MEAN|0.42||0.99|TWO_SIDED|95.0|-0.87|0.86||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of vegetables. It is an independent samples t test. It is testing the null hypothesis that the mean change in child vegetable servings per week from baseline to two-week follow up does not differ between conditions.||.86|-.87|.990
71760334|NCT04845568|143022302|SUPERIORITY||Mean Difference (Net)|-0.203|STANDARD_ERROR_OF_MEAN|0.32||0.527|TWO_SIDED|95.0|-0.86|0.45||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of fast food. It is an independent samples t test. It is testing the null hypothesis that the mean change in child fast food servings per week from baseline to two-week follow up does not differ between conditions.||.45|-.86|.527
71760335|NCT04845568|143022303|SUPERIORITY||Mean Difference (Net)|-0.159|STANDARD_ERROR_OF_MEAN|0.55||0.777|TWO_SIDED|95.0|-1.33|1.01||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child weekly intake of breakfast. It is an independent samples t test. It is testing the null hypothesis that the mean change in child breakfast meals per week from baseline to two-week follow up does not differ between conditions.||1.01|-1.33|.777
71760336|NCT04845568|143022303|SUPERIORITY||Mean Difference (Net)|-0.736|STANDARD_ERROR_OF_MEAN|0.74||0.329|TWO_SIDED|95.0|-2.26|0.79||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child intake of family dinners. It is an independent samples t test. It is testing the null hypothesis that the mean change in child family dinners per week from baseline to two-week follow up does not differ between conditions.||.79|-2.26|.329
71760337|NCT04845568|143022304|SUPERIORITY||Mean Difference (Net)|0.46|STANDARD_ERROR_OF_MEAN|0.26||0.086|TWO_SIDED|95.0|-0.07|0.99||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child screentime. It is an independent samples t test. It is testing the null hypothesis that the mean change in child screentime per week from baseline to two-week follow up does not differ between conditions.||.99|-0.07|.086
71760338|NCT04845568|143022304|SUPERIORITY||Mean Difference (Net)|-0.12|STANDARD_ERROR_OF_MEAN|0.25||0.64|TWO_SIDED|95.0|-0.64|0.4||A priori threshold for statistical significance set at p\<.05.|t-test, 2 sided|Degrees of freedom = 25||This analysis is for the outcome: Change in child active hours. It is an independent samples t test. It is testing the null hypothesis that the mean change in child active hours per week from baseline to two-week follow up does not differ between conditions.||.40|-.64|.64
71760339|NCT02908672|143022334|SUPERIORITY||Hazard Ratio (HR)|0.79||||0.0224|TWO_SIDED|95.0|0.64|0.97|||Log Rank||Stratified Hazard Ratio|||0.97|0.64|0.0224
71760340|NCT02908672|143022335|SUPERIORITY||Hazard Ratio (HR)|0.85||||0.1607|TWO_SIDED|95.0|0.67|1.07|||Log Rank||Stratified Hazard Ratio|||1.07|0.67|0.1607
71760341|NCT02908672|143022336|SUPERIORITY||Difference in response rate|1.63||||0.6997|TWO_SIDED|95.0|-6.9|10.15|||Cochran-Mantel-Haenszel|||||10.15|-6.90|0.6997
71760342|NCT02908672|143022338|SUPERIORITY||Hazard Ratio (HR)|0.84||||0.1191|TWO_SIDED|95.0|0.67|1.05|||Log Rank|||||1.05|0.67|0.1191
71760343|NCT02908672|143022339|SUPERIORITY||Difference in Event Free Rate|8.2||||0.0693|TWO_SIDED|95.0|-0.65|17.04|||Z-test|||||17.04|-0.65|0.0693
71760344|NCT00123422|143022352|SUPERIORITY_OR_OTHER|||||||0.015|TWO_SIDED|||||Statistical tests were 2-sided and a p value of \< 0.05 was the criterion for statistical significance.|ANCOVA|The baseline value was the co-variate in this analysis.||||||0.015
71760345|NCT00123422|143022353|SUPERIORITY_OR_OTHER||||||<|0.05|TWO_SIDED||||||ANCOVA|The baseline value was the co-variate in this analysis.||||||<0.05
71760346|NCT03089281|143022354|SUPERIORITY|||||||0.17|||||||Chi-squared|||||||0.17
71760347|NCT03089281|143022355|SUPERIORITY|||||||0.011|||||||t-test, 2 sided|||||||0.011
71760348|NCT03089281|143022356|SUPERIORITY|||||||0.029|||||||t-test, 2 sided|||||||0.029
71760349|NCT03089281|143022358|SUPERIORITY|||||||0.05|||||||t-test, 2 sided|||||||0.050
71760350|NCT03089281|143022359|SUPERIORITY|||||||0.49|||||||Cochran-Armitage Trend Test|||||||0.49
71760351|NCT03089281|143022360|SUPERIORITY|||||||0.36|||||||t-test, 2 sided|||||||0.36
71760352|NCT03089281|143022361|SUPERIORITY|||||||0.21|||||||t-test, 2 sided|||||||0.21
71760353|NCT03089281|143022362|SUPERIORITY|||||||0.34|||||||t-test, 2 sided|||||||0.34
71760354|NCT03089281|143022363|SUPERIORITY|||||||0.46|||||||t-test, 2 sided|||||||0.46
71760355|NCT03089281|143022364|SUPERIORITY|||||||0.45|||||||t-test, 2 sided|||||||0.45
71760356|NCT03089281|143022365|SUPERIORITY|||||||0.9|||||||t-test, 2 sided|||||||0.90
71760357|NCT03089281|143022366|SUPERIORITY|||||||0.59|||||||t-test, 2 sided|||||||0.59
71760358|NCT01255436|143022367|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-4.2||||0.06|TWO_SIDED|95.0|-9.4|1.0||p-value\<0.05 is considered significant|t-test, 1 sided|||||1.0|-9.4|0.06
71760359|NCT01255436|143022368|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-1.5||||0.14|TWO_SIDED|95.0|-4.1|1.3||p-value \< 0.05 considered significant|t-test, 1 sided|||||1.3|-4.1|0.14
71760360|NCT01255436|143022369|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.045|TWO_SIDED|95.0|1.0|1.6|||Fisher Exact||Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)|||1.6|1.0|0.045
71760361|NCT01255436|143022370|SUPERIORITY_OR_OTHER||Risk Ratio (RR)|1.3||||0.014|TWO_SIDED|95.0|1.04|1.53|||Fisher Exact|||||1.53|1.04|0.014
71760362|NCT01864603|143022385|OTHER||Risk Ratio (RR)|0.95|||||TWO_SIDED|95.0|0.77|1.17||||||Comparison of Phase 1 arms||1.17|0.77|
71760363|NCT01864603|143022386|OTHER||Rate ratio|0.26|||||TWO_SIDED|95.0|0.09|0.75||||||||0.75|0.09|
71760364|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Results presented were Bonferonni-corrected for a mid-point safety analysis||Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .||||<.0001
71760365|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||=|0.56|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=.56
71760366|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||<|0.0009|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0009
71760367|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71760368|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||<|0.006|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.006
71760369|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71760370|NCT01554241|143022402|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71760371|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED|||||analyses were corrected for multiple comparisons (Bonferroni)|ANOVA|||||||<.0001
71760372|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||=|0.47|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||=0.47
71760373|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||<|0.002|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.002
71760374|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71760375|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||<|0.02|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.02
71760376|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||<|0.0001|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0001
71760377|NCT01554241|143022403|SUPERIORITY_OR_OTHER||||||<|0.0003|TWO_SIDED||||||ANOVA|Bonferroni/Dunn adjustment||||||<.0003
71760378|NCT00539942|143022413|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|10.0|||<|0.05|||||||Chi-squared|||Unable to analyze data||||<.05
71760379|NCT05814367|143022423|NON_INFERIORITY|A non-inferiority margin of 0.05 logMAR was used.|Least-square Mean Difference|-0.005|STANDARD_ERROR_OF_MEAN|0.01|||TWO_SIDED|95.0|-0.025|0.014|||Linear Mixed Model|Kenward and Roger Method was used for the denominator degrees of freedom.|Mean difference was calculated as Test minus Control|The sample size of 38 was calculated to provide at least 90% statistical power to test Non-inferiority of the Test lens compared to the Control lens using a paired t-test with a two-sided type I error rate of 5%.||0.014|-0.025|
71760380|NCT00880919|143022427|SUPERIORITY_OR_OTHER|||||||0.015|||||||ANOVA|||Mean changes were calculated using each groups linear and quadratic effects||||.015
71760381|NCT00408200|143022461|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Fisher Exact|||||||<0.05
71760382|NCT02015637|143022465|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rate|-5.9|||||TWO_SIDED|95.0|-13.18|1.36||||||||1.36|-13.18|
71760383|NCT02015637|143022466|NON_INFERIORITY|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rates|-9.9|||||TWO_SIDED|95.0|-16.03|-3.87||||||||-3.87|-16.03|
71760384|NCT02223858|143022476|SUPERIORITY|A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.791|||||||Mixed Models Analysis|All models adjusted for site.||||||0.791
71760385|NCT02223858|143022477|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.88|||||||Mixed Models Analysis|All models adjusted for site.||||||0.880
71760386|NCT02223858|143022478|SUPERIORITY|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.||||||0.901|||||||Mixed Models Analysis|All models adjusted for site.||||||0.901
71760387|NCT02106390|143022489|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|0.89|||||TWO_SIDED|95.0|0.71|1.1|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||"H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination."||1.10|0.71|
71760388|NCT02106390|143022489|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.74|1.45|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.||1.45|0.74|
71760389|NCT02106390|143022489|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.01|||||TWO_SIDED|95.0|0.82|1.25|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.||1.25|0.82|
71760390|NCT02106390|143022489|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is \> 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||TWO_SIDED|95.0|0.77|1.4|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.||1.40|0.77|
71760391|NCT02106390|143022490|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|2.48|||||TWO_SIDED|95.0|1.97|3.11|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.||3.11|1.97|
71760392|NCT02106390|143022490|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.07|||||TWO_SIDED|95.0|0.83|1.38|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.||1.38|0.83|
71760393|NCT02106390|143022490|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.34|||||TWO_SIDED|95.0|1.04|1.74|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.||1.74|1.04|
71760394|NCT02106390|143022490|NON_INFERIORITY|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was \> 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.05|||||TWO_SIDED|95.0|0.82|1.35|||ANOVA|The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group \& center as factors in the model||Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.||1.35|0.82|
71760395|NCT03198507|143022522|SUPERIORITY|||||||0.0001|TWO_SIDED|95.0||||Statistical testing was 2 sided and performed using a significance (alpha) level of 0.05.|t-test, 2 sided|||||||0.0001
71760396|NCT03198507|143022525|SUPERIORITY|||||||0.0001|||||||t-test, 2 sided|||||||0.0001
71760397|NCT00241839|143022534|SUPERIORITY_OR_OTHER||Mean Difference (Net)|4.27|STANDARD_ERROR_OF_MEAN|2.24||0.059|TWO_SIDED|95.0|-0.17|8.7|||t-test, 2 sided|Satterthwaite correction for possibly unequal variance was made|A positive value of the estimated value would favor the allopurinol arm. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We compared the drop in baseline of diastolic BP for the two treatment groups Allopurinol vs. Placebo by a Satterthwaite corrected t-test.||8.7|-0.17|0.059
71760398|NCT00241839|143022535|SUPERIORITY_OR_OTHER||Mean Difference (Net)|1.16|STANDARD_ERROR_OF_MEAN|1.59||0.47|TWO_SIDED|95.0|-2.0|4.3||Positive numbers indicate a drop. We compared baseline minus value at treatment end for the two treatments.|t-test, 2 sided|Satterthwaite correction was used for potentially unequal variances.|The analysis is limited to those with both baseline and 8-10 week data on this variable.|||4.3|-2.0|0.47
71760399|NCT00241839|143022536|SUPERIORITY_OR_OTHER||Median Difference (Net)|-6.76|STANDARD_ERROR_OF_MEAN|2.11||0.002|TWO_SIDED|95.0|-11.0|-2.6|||t-test, 2 sided|Sattherthwaite correction was used|The analysis is limited to those with both baseline and 8-10 week data on this variable. The 24 hour was in the opposite direction of the cuff.|||-2.6|-11.0|0.0020
71760400|NCT00241839|143022537|SUPERIORITY_OR_OTHER||Median Difference (Net)|2.15|STANDARD_ERROR_OF_MEAN|0.22|<|0.001|TWO_SIDED|95.0|1.72|2.59|||t-test, 2 sided|Satterthwaite correction was used.|Allopurinol was associated with a significant decrease in uric acid over the treatment period as compared to placebo. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We expected allopurinol to be associated with a decrease in uric acid.||2.59|1.72|<0.001
71760401|NCT00439517|143022547|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.677||||0.0048|TWO_SIDED|95.0|0.515|0.889|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||0.889|0.515|0.0048
71760402|NCT00439517|143022548|SUPERIORITY_OR_OTHER||Odds Ratio (OR)|1.756||||0.016|TWO_SIDED|95.0|1.11|2.777|||Cochran-Mantel-Haenszel|Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.||||2.777|1.110|0.016
71760403|NCT00439517|143022549|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.855||||0.3797|TWO_SIDED|95.0|0.603|1.213|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||||1.213|0.603|0.3797
71760404|NCT00439517|143022550|SUPERIORITY_OR_OTHER||Hazard Ratio (HR)|0.977||||0.8575|TWO_SIDED|95.0|0.755|1.263|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||1.263|0.755|0.8575
71760405|NCT02304367|143022558|OTHER|||||||0.0428|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in osteoid thickness is zero was tested using a t-test.||||0.0428
71760406|NCT02304367|143022559|OTHER|||||||0.977|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OS/BS is zero was tested using a t-test.||||0.9770
71760407|NCT02304367|143022560|OTHER|||||||0.0858|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in OV/BV is zero was tested using a t-test.||||0.0858
71760408|NCT02304367|143022561|OTHER|||||||0.4077|||||||t-test|||The null hypothesis that the mean change from Baseline to Week 48 in Mlt is zero was tested using a t-test.||||0.4077
71760409|NCT02304367|143022568|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 24||||0.016
71760410|NCT02304367|143022568|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 48||||0.030
71760411|NCT02304367|143022568|OTHER|||||||0.259|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 96||||0.259
71760412|NCT02304367|143022568|OTHER|||||||0.346|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 144||||0.346
71760413|NCT02304367|143022568|OTHER|||||||0.213|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 168||||0.213
71760414|NCT02304367|143022568|OTHER|||||||0.873|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 192||||0.873
71760415|NCT02304367|143022568|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 216||||0.001
71760416|NCT02304367|143022568|OTHER|||||||0.04|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 1,25(OH)2D.||Week 240||||0.040
71760417|NCT02304367|143022569|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 24||||<0.0001
71760418|NCT02304367|143022569|OTHER||||||<|0.0001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 48||||<0.0001
71760419|NCT02304367|143022569|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 96||||0.001
71760420|NCT02304367|143022569|OTHER|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 144||||0.007
71760421|NCT02304367|143022569|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 168||||0.005
71760422|NCT02304367|143022569|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 192||||0.004
71760423|NCT02304367|143022569|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 216||||0.002
71760424|NCT02304367|143022569|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline total FGF23.||Week 240||||0.006
71760425|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 24||||< 0.001
71760426|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 48||||< 0.001
71760427|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 96||||<0.001
71760428|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 144||||< 0.001
71760429|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 168||||< 0.001
71760430|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 192||||< 0.001
71760431|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 216||||< 0.001
71760432|NCT02304367|143022570|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline free FGF23.||Week 240||||< 0.001
71760433|NCT02304367|143022571|OTHER|||||||0.659|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 24||||0.659
71760434|NCT02304367|143022571|OTHER|||||||0.752|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 48||||0.752
71760435|NCT02304367|143022571|OTHER|||||||0.594|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 96||||0.594
71760436|NCT02304367|143022571|OTHER|||||||0.614|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 144||||0.614
71760437|NCT02304367|143022571|OTHER|||||||0.542|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 168||||0.542
71760438|NCT02304367|143022571|OTHER|||||||0.067|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 192||||0.067
71760439|NCT02304367|143022571|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 216||||0.330
71760440|NCT02304367|143022571|SUPERIORITY|||||||0.161|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline 24-hour urinary phosphorus.||Week 240||||0.161
71760441|NCT02304367|143022572|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 24||||< 0.001
71760442|NCT02304367|143022572|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 48||||< 0.001
71760443|NCT02304367|143022572|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 96||||0.001
71760444|NCT02304367|143022572|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 144||||< 0.001
71760445|NCT02304367|143022572|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 168||||< 0.001
71760446|NCT02304367|143022572|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 192||||< 0.001
71760447|NCT02304367|143022572|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 216||||< 0.001
71760448|NCT02304367|143022572|SUPERIORITY||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TRP.||Week 240||||< 0.001
71760449|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 24||||< 0.001
71760450|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 48||||< 0.001
71760451|NCT02304367|143022573|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 96||||0.002
71760452|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR||Week 144||||< 0.001
71760453|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 168||||< 0.001
71760454|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 192||||< 0.001
71760455|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 216||||< 0.001
71760456|NCT02304367|143022573|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline TmP/GFR.||Week 240||||< 0.001
71760457|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 24||||< 0.001
71760458|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 48||||< 0.001
71760459|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 96||||< 0.001
71760460|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 144||||< 0.001
71760461|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 168||||< 0.001
71760462|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 192||||< 0.001
71760463|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 216||||< 0.001
71760464|NCT02304367|143022574|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline FEP.||Week 240||||< 0.001
71760465|NCT02304367|143022575|OTHER|||||||0.878|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 24||||0.878
71760466|NCT02304367|143022575|OTHER|||||||0.081|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 48||||0.081
71760467|NCT02304367|143022575|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 96||||0.001
71760468|NCT02304367|143022575|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 144||||< 0.001
71760469|NCT02304367|143022575|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 168||||< 0.001
71760470|NCT02304367|143022575|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 192||||< 0.001
71760471|NCT02304367|143022575|OTHER|||||||0.055|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 216||||0.055
71760472|NCT02304367|143022575|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline ALP.||Week 240||||0.041
71760473|NCT02304367|143022576|OTHER|||||||0.817|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.817
71760474|NCT02304367|143022576|OTHER|||||||0.042|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.042
71760475|NCT02304367|143022576|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
71760476|NCT02304367|143022576|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
71760477|NCT02304367|143022576|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
71760478|NCT02304367|143022576|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
71760479|NCT02304367|143022576|OTHER|||||||0.174|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.174
71760480|NCT02304367|143022576|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
71760481|NCT02304367|143022577|OTHER|||||||0.694|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 24||||0.694
71760482|NCT02304367|143022577|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 48||||0.047
71760483|NCT02304367|143022577|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 96||||< 0.001
71760484|NCT02304367|143022577|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 144||||< 0.001
71760485|NCT02304367|143022577|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 168||||< 0.001
71760486|NCT02304367|143022577|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 192||||< 0.001
71760487|NCT02304367|143022577|OTHER|||||||0.17|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 216||||0.170
71760488|NCT02304367|143022577|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline BALP.||Week 240||||< 0.001
71760489|NCT02304367|143022578|OTHER|||||||0.09|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.090
71760490|NCT02304367|143022578|OTHER|||||||0.226|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.226
71760491|NCT02304367|143022578|OTHER|||||||0.918|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.918
71760492|NCT02304367|143022578|OTHER|||||||0.616|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.616
71760493|NCT02304367|143022578|OTHER|||||||0.041|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.041
71760494|NCT02304367|143022578|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.002
71760495|NCT02304367|143022578|OTHER|||||||0.137|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.137
71760496|NCT02304367|143022578|OTHER|||||||0.368|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.368
71760497|NCT02304367|143022579|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 24||||0.018
71760498|NCT02304367|143022579|OTHER|||||||0.133|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 48||||0.133
71760499|NCT02304367|143022579|OTHER|||||||0.321|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 96||||0.321
71760500|NCT02304367|143022579|OTHER|||||||0.218|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 144||||0.218
71760501|NCT02304367|143022579|OTHER|||||||0.788|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 168||||0.788
71760502|NCT02304367|143022579|OTHER|||||||0.156|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 192||||0.156
71760503|NCT02304367|143022579|OTHER|||||||0.155|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 216||||0.155
71760504|NCT02304367|143022579|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline CTx.||Week 240||||0.580
71760505|NCT02304367|143022580|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.002
71760506|NCT02304367|143022580|OTHER|||||||0.273|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.273
71760507|NCT02304367|143022580|OTHER|||||||0.469|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.469
71760508|NCT02304367|143022580|OTHER|||||||0.828|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.828
71760509|NCT02304367|143022580|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||< 0.001
71760510|NCT02304367|143022580|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.141
71760511|NCT02304367|143022580|OTHER|||||||0.606|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.606
71760512|NCT02304367|143022580|OTHER|||||||0.907|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.907
71760513|NCT02304367|143022581|OTHER|||||||0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 24||||0.001
71760514|NCT02304367|143022581|OTHER|||||||0.149|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 48||||0.149
71760515|NCT02304367|143022581|OTHER|||||||0.372|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 96||||0.372
71760516|NCT02304367|143022581|OTHER|||||||0.116|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 144||||0.116
71760517|NCT02304367|143022581|OTHER|||||||0.013|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 168||||0.013
71760518|NCT02304367|143022581|OTHER|||||||0.962|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 192||||0.962
71760519|NCT02304367|143022581|OTHER|||||||0.664|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 216||||0.664
71760520|NCT02304367|143022581|OTHER|||||||0.79|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline P1NP.||Week 240||||0.790
71760521|NCT02304367|143022582|OTHER|||||||0.05|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||0.050
71760522|NCT02304367|143022582|OTHER|||||||0.526|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.526
71760523|NCT02304367|143022582|OTHER|||||||0.845|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.845
71760524|NCT02304367|143022582|OTHER|||||||0.782|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.782
71760525|NCT02304367|143022582|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.020
71760526|NCT02304367|143022582|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.005
71760527|NCT02304367|143022582|OTHER|||||||0.136|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 216||||0.136
71760528|NCT02304367|143022582|OTHER|||||||0.101|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.101
71760529|NCT02304367|143022583|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 24||||< 0.001
71760530|NCT02304367|143022583|OTHER|||||||0.238|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 48||||0.238
71760531|NCT02304367|143022583|OTHER|||||||0.286|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 96||||0.286
71760532|NCT02304367|143022583|OTHER|||||||0.093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 144||||0.093
71760533|NCT02304367|143022583|OTHER|||||||0.89|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 168||||0.890
71760534|NCT02304367|143022583|OTHER|||||||0.059|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 192||||0.059
71760535|NCT02304367|143022583|SUPERIORITY|||||||0.623||||||Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.|GEE model|||Week 216||||0.623
71760536|NCT02304367|143022583|OTHER|||||||0.411|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline osteocalcin.||Week 240||||0.411
71760537|NCT02304367|143022584|OTHER|||||||0.8209|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.8209
71760538|NCT02304367|143022584|OTHER|||||||0.2851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2851
71760539|NCT02304367|143022584|OTHER|||||||0.6689|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.6689
71760540|NCT02304367|143022584|OTHER|||||||0.1612|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1612
71760541|NCT02304367|143022585|OTHER|||||||0.4093|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.4093
71760542|NCT02304367|143022585|OTHER|||||||0.572|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5720
71760543|NCT02304367|143022585|OTHER|||||||0.3501|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.3501
71760544|NCT02304367|143022585|OTHER|||||||0.5172|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.5172
71760545|NCT02304367|143022586|OTHER|||||||0.0046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 24||||0.0046
71760546|NCT02304367|143022586|OTHER|||||||0.0012|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline STS measurement.||Week 48||||0.0012
71760547|NCT02304367|143022587|OTHER|||||||0.6475|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.6475
71760548|NCT02304367|143022587|OTHER|||||||0.5319|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.5319
71760549|NCT02304367|143022587|OTHER|||||||0.9206|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.9206
71760550|NCT02304367|143022587|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1530
71760551|NCT02304367|143022588|OTHER|||||||0.2125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.2125
71760552|NCT02304367|143022588|OTHER|||||||0.1241|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.1241
71760553|NCT02304367|143022589|OTHER|||||||0.41|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.410
71760554|NCT02304367|143022589|OTHER|||||||0.21|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.210
71760555|NCT02304367|143022589|OTHER|||||||0.06|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.060
71760556|NCT02304367|143022589|OTHER|||||||0.076|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.076
71760557|NCT02304367|143022589|OTHER|||||||0.171|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.171
71760558|NCT02304367|143022589|OTHER|||||||0.141|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.141
71760559|NCT02304367|143022589|OTHER|||||||0.263|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.263
71760560|NCT02304367|143022589|OTHER|||||||0.32|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.320
71760561|NCT02304367|143022590|OTHER|||||||0.407|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.407
71760562|NCT02304367|143022590|OTHER|||||||0.192|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.192
71760563|NCT02304367|143022590|OTHER|||||||0.106|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.106
71760564|NCT02304367|143022590|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.020
71760565|NCT02304367|143022590|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.002
71760566|NCT02304367|143022590|OTHER|||||||0.22|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.220
71760567|NCT02304367|143022590|OTHER|||||||0.23|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.230
71760568|NCT02304367|143022590|OTHER|||||||0.232|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.232
71760569|NCT02304367|143022591|OTHER|||||||0.082|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.082
71760570|NCT02304367|143022591|OTHER|||||||0.176|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.176
71760571|NCT02304367|143022591|OTHER|||||||0.047|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.047
71760572|NCT02304367|143022591|OTHER|||||||0.017|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.017
71760573|NCT02304367|143022591|OTHER|||||||0|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.000
71760574|NCT02304367|143022591|OTHER|||||||0.057|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.057
71760575|NCT02304367|143022591|OTHER|||||||0.071|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.071
71760576|NCT02304367|143022591|OTHER|||||||0.07|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.070
71760577|NCT02304367|143022592|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.014
71760578|NCT02304367|143022592|OTHER|||||||0.309|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.309
71760579|NCT02304367|143022592|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.036
71760580|NCT02304367|143022592|OTHER|||||||0.096|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.096
71760581|NCT02304367|143022592|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.005
71760582|NCT02304367|143022592|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.022
71760583|NCT02304367|143022592|OTHER|||||||0.022|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.022
71760584|NCT02304367|143022592|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.004
71760585|NCT02304367|143022593|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
71760586|NCT02304367|143022593|OTHER|||||||0.019|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.019
71760587|NCT02304367|143022593|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
71760588|NCT02304367|143022593|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.006
71760589|NCT02304367|143022593|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
71760590|NCT02304367|143022593|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||< 0.001
71760591|NCT02304367|143022593|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.002
71760592|NCT02304367|143022593|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.002
71760593|NCT02304367|143022594|OTHER|||||||0.016|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.016
71760594|NCT02304367|143022594|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.004
71760595|NCT02304367|143022594|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
71760596|NCT02304367|143022594|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71760597|NCT02304367|143022594|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
71760598|NCT02304367|143022594|OTHER|||||||0.036|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.036
71760599|NCT02304367|143022594|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.008
71760600|NCT02304367|143022594|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.008
71760601|NCT02304367|143022595|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.006
71760602|NCT02304367|143022595|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.003
71760603|NCT02304367|143022595|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||<0.001
71760604|NCT02304367|143022595|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71760605|NCT02304367|143022595|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||< 0.001
71760606|NCT02304367|143022595|SUPERIORITY|||||||0.007|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.007
71760607|NCT02304367|143022595|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.005
71760608|NCT02304367|143022595|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
71760609|NCT02304367|143022596|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.009
71760610|NCT02304367|143022596|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.020
71760611|NCT02304367|143022596|OTHER|||||||0.044|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.044
71760612|NCT02304367|143022596|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71760613|NCT02304367|143022596|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.015
71760614|NCT02304367|143022596|OTHER|||||||0.125|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.125
71760615|NCT02304367|143022596|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.004
71760616|NCT02304367|143022596|OTHER|||||||0.018|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.018
71760617|NCT02304367|143022597|OTHER|||||||0.148|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.148
71760618|NCT02304367|143022597|OTHER|||||||0.295|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.295
71760619|NCT02304367|143022597|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.005
71760620|NCT02304367|143022597|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||< 0.001
71760621|NCT02304367|143022597|OTHER|||||||0.014|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.014
71760622|NCT02304367|143022597|OTHER|||||||0.14|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.140
71760623|NCT02304367|143022597|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
71760624|NCT02304367|143022597|OTHER|||||||0.142|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.142
71760625|NCT02304367|143022598|OTHER|||||||0.005|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.005
71760626|NCT02304367|143022598|OTHER|||||||0.077|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.077
71760627|NCT02304367|143022598|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.046
71760628|NCT02304367|143022598|OTHER|||||||0.049|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.049
71760629|NCT02304367|143022598|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.003
71760630|NCT02304367|143022598|OTHER|||||||0.073|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.073
71760631|NCT02304367|143022598|OTHER|||||||0.109|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.109
71760632|NCT02304367|143022598|OTHER|||||||0.006|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.006
71760633|NCT02304367|143022599|OTHER|||||||0.328|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.328
71760634|NCT02304367|143022599|OTHER|||||||0.015|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.015
71760635|NCT02304367|143022599|OTHER|||||||0.02|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.020
71760636|NCT02304367|143022599|OTHER|||||||0.004|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.004
71760637|NCT02304367|143022599|OTHER|||||||0.021|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.021
71760638|NCT02304367|143022599|OTHER|||||||0.08|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.080
71760639|NCT02304367|143022599|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||< 0.001
71760640|NCT02304367|143022599|OTHER|||||||0.003|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.003
71760641|NCT02304367|143022600|OTHER|||||||0.207|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.207
71760642|NCT02304367|143022600|OTHER|||||||0.008|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.008
71760643|NCT02304367|143022600|OTHER|||||||0.598|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.598
71760644|NCT02304367|143022600|OTHER|||||||0.237|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.237
71760645|NCT02304367|143022600|OTHER|||||||0.899|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.899
71760646|NCT02304367|143022600|OTHER|||||||0.585|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.585
71760647|NCT02304367|143022600|OTHER|||||||0.461|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.461
71760648|NCT02304367|143022600|OTHER|||||||0.583|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.583
71760649|NCT02304367|143022601|OTHER|||||||0.654|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.654
71760650|NCT02304367|143022601|OTHER|||||||0.579|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.579
71760651|NCT02304367|143022601|OTHER|||||||0.123|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.123
71760652|NCT02304367|143022601|OTHER|||||||0.712|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.712
71760653|NCT02304367|143022601|OTHER|||||||0.258|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.258
71760654|NCT02304367|143022601|OTHER|||||||0.851|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.851
71760655|NCT02304367|143022601|OTHER|||||||0.849|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.849
71760656|NCT02304367|143022601|OTHER|||||||0.153|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.153
71760657|NCT02304367|143022602|OTHER|||||||0.002|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.002
71760658|NCT02304367|143022602|OTHER|||||||0.03|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.030
71760659|NCT02304367|143022602|OTHER|||||||0.011|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.011
71760660|NCT02304367|143022602|OTHER|||||||0.186|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.186
71760661|NCT02304367|143022602|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
71760662|NCT02304367|143022602|OTHER|||||||0.33|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.330
71760663|NCT02304367|143022602|OTHER|||||||0.072|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.072
71760664|NCT02304367|143022602|OTHER|||||||0.045|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.045
71760665|NCT02304367|143022603|OTHER|||||||0.369|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.369
71760666|NCT02304367|143022603|OTHER|||||||0.026|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.026
71760667|NCT02304367|143022603|OTHER||||||<|0.001|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||< 0.001
71760668|NCT02304367|143022603|OTHER|||||||0.235|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.235
71760669|NCT02304367|143022603|OTHER|||||||0.009|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.009
71760670|NCT02304367|143022603|OTHER|||||||0.278|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.278
71760671|NCT02304367|143022603|OTHER|||||||0.046|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.046
71760672|NCT02304367|143022603|OTHER|||||||0.035|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.035
71760673|NCT02304367|143022604|OTHER|||||||0.442|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.442
71760674|NCT02304367|143022604|OTHER|||||||0.677|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.677
71760675|NCT02304367|143022604|OTHER|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.027
71760676|NCT02304367|143022604|OTHER|||||||0.42|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.420
71760677|NCT02304367|143022604|SUPERIORITY|||||||0.027|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.027
71760678|NCT02304367|143022604|OTHER|||||||0.312|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.312
71760679|NCT02304367|143022604|OTHER|||||||0.249|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.249
71760680|NCT02304367|143022604|OTHER|||||||0.102|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.102
71760681|NCT02304367|143022605|OTHER|||||||0.856|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 24||||0.856
71760682|NCT02304367|143022605|OTHER|||||||0.898|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 48||||0.898
71760683|NCT02304367|143022605|OTHER|||||||0.785|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 96||||0.785
71760684|NCT02304367|143022605|OTHER|||||||0.932|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 144||||0.932
71760685|NCT02304367|143022605|OTHER|||||||0.545|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 168||||0.545
71760686|NCT02304367|143022605|OTHER|||||||0.58|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 192||||0.580
71760687|NCT02304367|143022605|OTHER|||||||0.462|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 216||||0.462
71760688|NCT02304367|143022605|OTHER|||||||0.26|||||||GEE model|Generalized estimation equation (GEE) model includes time as the categorical variable and adjusted for Baseline measurement.||Week 240||||0.260
71760689|NCT02983552|143022640|SUPERIORITY||Mean Difference (Final Values)|-0.3||||0.71|TWO_SIDED|95.0|-2.2|1.7||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 4 week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 4 weeks. A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 4 weeks. There was no imputation for missing data.||1.7|-2.2|0.71
71760690|NCT02983552|143022642|SUPERIORITY||Mean Difference (Final Values)|-0.1|||||TWO_SIDED|98.3|-2.4|2.1|||||A 2-sided 98.3% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 8-week visit.|||2.1|-2.4|
71760691|NCT02983552|143022648|SUPERIORITY||Mean Difference (Final Values)|-2.0|||||TWO_SIDED|98.3|-13.0|9.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 4-week visit, adjusted for visual acuity at randomization.||9|-13|
71760692|NCT02983552|143022649|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|98.3|-15.0|12.0||||||Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 8-week visit, adjusted for visual acuity at randomization.|For secondary visual acuity outcomes, which included the 8-week treatment group comparison, a Bonferroni adjustment was used to control for multiple testing (3 outcomes tested) to preserve the overall type I error rate at 5% (2-sided alpha=0.017 per test).|12|-15|
71760693|NCT02983552|143022651|SUPERIORITY|||||||0.38||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.38
71760694|NCT02983552|143022653|SUPERIORITY|||||||0.53||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group.|Wilcoxon (Mann-Whitney)|||||||0.53
71760695|NCT02983552|143022655|SUPERIORITY|||||||0.19||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 4-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.19
71760696|NCT02983552|143022657|SUPERIORITY|||||||0.74||||||The exact Wilcoxon rank-sum test was used to compare the change in stereoacuity levels from baseline to the 8-week visit by treatment group for participants without strabismus.|Wilcoxon (Mann-Whitney)|||||||0.74
71760697|NCT02983552|143022662|SUPERIORITY||Mean Difference (Final Values)|-1.1|||||TWO_SIDED|99.0|-2.5|0.4|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 4 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.4|-2.5|
71760698|NCT02983552|143022663|SUPERIORITY||Mean Difference (Final Values)|-1.0|||||TWO_SIDED|99.0|-2.3|0.3|||||Statistical significance of the treatment group comparison was based on a 2-sided alpha=0.01.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 8 weeks, adjusting for fellow-eye visual acuity at randomization. A 2-sided 99% confidence interval was computed on the adjusted treatment group difference.||0.3|-2.3|
71760699|NCT02983552|143022664|SUPERIORITY|||||||0.37|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 4-week visit.||||0.37
71760700|NCT02983552|143022665|SUPERIORITY|||||||0.99|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 8-week visit.||||0.99
71760701|NCT02983552|143022666|SUPERIORITY|||||||0.2|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.20
71760702|NCT02983552|143022667|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
71760703|NCT02983552|143022668|SUPERIORITY|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.44
71760704|NCT02983552|143022669|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
71760705|NCT02983552|143022670|SUPERIORITY|||||||0.12|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||0.12
71760706|NCT02983552|143022671|SUPERIORITY||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.||||>0.99
71760707|NCT02983552|143022672|SUPERIORITY|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 4-week visit by treatment group.||||0.12
71760708|NCT02983552|143022673|SUPERIORITY||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||The exact Wilcoxon rank-sum test was used to compare the change in diplopia frequency levels from baseline to the 8-week visit by treatment group.||||>0.99
71760709|NCT02983552|143022676|SUPERIORITY|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 4-week visit by treatment group.||||0.07
71760710|NCT02983552|143022677|SUPERIORITY|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||For each Symptom Survey item, the exact Wilcoxon rank-sum test was used to compare the change in symptom frequency level from baseline to the 8-week visit by treatment group. This was utilized for each item in the survey.||||0.06
71760711|NCT02983552|143022680|SUPERIORITY||||||>|0.01||||||Statistical significance of the interaction term was based on a 2-sided alpha=0.01.|ANCOVA|||An analysis of covariance (ANCOVA) was performed to test the 2-way interaction between treatment group with each factor (baseline age and visual acuity were treated as continuous factors), adjusting for baseline amblyopic-eye visual acuity and the nested terms from the interaction term. Formal subgroup analyses were only performed if there was a minimum of 20 participants in every subgroup category across both treatment groups for factors treated as categorical variables in the model.||||>0.01
71760712|NCT01216189|143022686|SUPERIORITY||Mean change|-0.138||||0.004|TWO_SIDED|95.0|-0.232|-0.044||The threshold for statistical significance was p = 0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||-0.044|-0.232|0.004
71760713|NCT01216189|143022686|SUPERIORITY||Mean change|-0.011||||0.805|TWO_SIDED|95.0|-0.097|0.075||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for menopausal status.||The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).||0.075|-0.097|0.805
71760714|NCT01216189|143022687|SUPERIORITY||Mean change in FSFI scores|-9.33||||0.013|TWO_SIDED|95.0|-16.66|-1.99||The threshold for statistical significance was p=0.05.|Regression, Linear|Model adjusted for Age, Psychological General Well-being total score and relationship with partner.||"The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using no preoperative radiotherapy as the reference group."||-1.99|-16.66|0.013
71760715|NCT01469377|143022688|SUPERIORITY||Least squares mean difference|-0.9||||0.2404|TWO_SIDED|95.0|-2.4|0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.6|-2.4|0.2404
71760716|NCT01469377|143022688|SUPERIORITY||Least squares mean difference|-2.2||||0.0114|TWO_SIDED|95.0|-3.7|-0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||-0.6|-3.7|0.0114
71760717|NCT01469377|143022689|SUPERIORITY||Least squares mean difference|-1.1||||0.2404|TWO_SIDED|95.0|-2.5|0.3||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.3|-2.5|0.2404
71760718|NCT01469377|143022689|SUPERIORITY||Least squares mean difference|-1.4||||0.114|TWO_SIDED|95.0|-2.8|0.0||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.||||0.0|-2.8|0.1140
71760719|NCT02817464|143022761|OTHER||Geometric Mean Ratio|1.84|||||TWO_SIDED|90.0|1.44|2.36||||||||2.36|1.44|
71760720|NCT02817464|143022762|OTHER||Geometric Mean Ratio|0.66|||||TWO_SIDED|90.0|0.33|1.33||||||||1.33|0.33|
71760721|NCT02817464|143022764|OTHER||Geometric Mean Ratio|1.67|||||TWO_SIDED|90.0|1.33|2.09||||||||2.09|1.33|
71760722|NCT02817464|143022765|OTHER||Geometric Mean Ratio|1.61|||||TWO_SIDED|90.0|1.3|2.01||||||||2.01|1.30|
71760723|NCT02817464|143022766|OTHER||Geometric Mean Ratio|1.21|||||TWO_SIDED|90.0|1.04|1.4||||||||1.40|1.04|
71760724|NCT02817464|143022767|OTHER||Geometric Mean Ratio|0.51|||||TWO_SIDED|90.0|0.23|1.13||||||||1.13|0.23|
71760725|NCT02817464|143022769|OTHER|||||||0.0073|||||||Log Rank|||||||0.0073
71760726|NCT04292899|143022806|SUPERIORITY||Odds Ratio (OR)|0.75||||0.1563|TWO_SIDED|95.0|0.507|1.115||P-value was calculated using a proportional odds model with treatment as the independent variable and baseline clinical status as a continuous covariate.|Proportional odds model|||||1.115|0.507|0.1563
71760727|NCT04292899|143022806|SUPERIORITY||Odds Ratio (OR)|0.67||||0.0368|TWO_SIDED|95.0|0.458|0.976||P-value was calculated using a proportional odds model with treatment as the independent variable.|Proportional odds model|||||0.976|0.458|0.0368
71760728|NCT04292899|143022807|SUPERIORITY||Difference in Percentages|1.3||||0.7678|TWO_SIDED|95.0|-7.4|10.0||P-value for comparison of the percentages between the two groups was calculated using the Cochran-Mantel-Haenszel test stratified on baseline clinical status.|Cochran-Mantel-Haenszel|||||10.0|-7.4|0.7678
71760729|NCT00298558|143022823|SUPERIORITY_OR_OTHER||Effect Size|0.06||||0.43|TWO_SIDED|99.0|-0.14|0.27|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.27|-0.14|0.43
71760730|NCT00298558|143022823|SUPERIORITY_OR_OTHER||Effect Size|-0.11||||0.17|TWO_SIDED|99.0|-0.31|0.1|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.10|-0.31|0.17
71760731|NCT00298558|143022823|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.52|TWO_SIDED|99.0|-0.25|0.15|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.15|-0.25|0.52
71760732|NCT00298558|143022826|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.69|TWO_SIDED|99.0|-0.17|0.12|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.12|-0.17|0.69
71760733|NCT00298558|143022826|SUPERIORITY_OR_OTHER||Effect Size|0.23|||<|0.01|TWO_SIDED|99.0|0.09|0.38|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.38|0.09|<0.01
71760734|NCT00298558|143022826|SUPERIORITY_OR_OTHER||Effect Size|-0.06||||0.27|TWO_SIDED|99.0|-0.2|0.08|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.08|-0.20|0.27
71760735|NCT00298558|143022828|SUPERIORITY_OR_OTHER||Effect Size|-0.07||||0.45|TWO_SIDED|99.0|-0.29|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.29|0.45
71760736|NCT00298558|143022828|SUPERIORITY_OR_OTHER||Effect Size|0.005||||0.95|TWO_SIDED|99.0|-0.22|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.22|0.95
71760737|NCT00298558|143022828|SUPERIORITY_OR_OTHER||Effect Size|0.66|||<|0.01|TWO_SIDED|99.0|0.43|0.88|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.88|0.43|<0.01
71761179|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.3|STANDARD_ERROR_OF_MEAN|0.1||0.0161|TWO_SIDED|95.0|-0.5|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.||-0.1|-0.5|0.0161
71760738|NCT00298558|143022829|SUPERIORITY_OR_OTHER||Effect Size|0.48|||<|0.01|TWO_SIDED|99.0|0.12|0.84|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.84|0.12|<0.01
71760739|NCT00298558|143022829|SUPERIORITY_OR_OTHER||Effect Size|0.38|||<|0.01|TWO_SIDED|99.0|0.02|0.74|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.74|0.02|<0.01
71760740|NCT00298558|143022829|SUPERIORITY_OR_OTHER||Effect Size|0.36|||<|0.01|TWO_SIDED|99.0|0.01|0.72|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.72|0.01|<0.01
71760741|NCT00298558|143022830|SUPERIORITY_OR_OTHER||Effect Size|0.004||||0.97|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.97
71760742|NCT00298558|143022830|SUPERIORITY_OR_OTHER||Effect Size|-0.02||||0.86|TWO_SIDED|99.0|-0.25|0.22|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.22|-0.25|0.86
71760743|NCT00298558|143022830|SUPERIORITY_OR_OTHER||Effect Size|0.008||||0.93|TWO_SIDED|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.24|-0.23|0.93
71760744|NCT00298558|143022831|SUPERIORITY_OR_OTHER||Effect Size|0.02||||0.78|TWO_SIDED|99.0|-0.19|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.23|-0.19|0.78
71760745|NCT00298558|143022831|SUPERIORITY_OR_OTHER||Effect Size|-0.004||||0.96|TWO_SIDED|99.0|-0.21|0.21|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.21|-0.21|0.96
71760746|NCT00298558|143022831|SUPERIORITY_OR_OTHER||Effect Size|-0.05||||0.56|TWO_SIDED|99.0|-0.26|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.||0.16|-0.26|0.56
71760747|NCT01322945|143022864|SUPERIORITY_OR_OTHER|||||||0.001||95.0|||||t-test, 2 sided|||||||0.001
71760748|NCT02605122|143022885|OTHER||Proportion experiencing TEAE or TESAE|34.3|||||TWO_SIDED|95.0|23.0|47.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||47|23|
71760749|NCT02605122|143022886|OTHER||Achievement of ECR|62.1|||||TWO_SIDED|95.0|49.0|74.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||74|49|
71760750|NCT02605122|143022887|OTHER||Achievement of Clinical Improvement|68.7|||||TWO_SIDED|95.0|58.0|78.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson analysis was used to determine confidence intervals.|Clopper-Pearson|||||78|58|
71760751|NCT02605122|143022888|OTHER||Achievement of Clinical Cure|62.0|||||TWO_SIDED|95.0|50.0|73.0||No p-value was performed. Study prematurely discontinued. Clopper-Pearson was used to determine confidence intervals.|Clopper-Pearson|||||73|50|
71760752|NCT04603027|143022889|SUPERIORITY||Posterior Mean difference|-5.99|||||TWO_SIDED|95.0|-20.28|7.12||||||||7.12|-20.28|
71760753|NCT04603027|143022889|SUPERIORITY||Posterior Mean difference|-8.35|||||TWO_SIDED|95.0|-22.07|5.04||||||||5.04|-22.07|
71760754|NCT04603027|143022889|SUPERIORITY||Posterior Mean difference|-9.1|||||TWO_SIDED|95.0|-23.22|4.65||||||||4.65|-23.22|
71760755|NCT04603027|143022890|SUPERIORITY||Posterior Mean difference|-2.6|||||TWO_SIDED|95.0|-13.91|9.9||||||||9.90|-13.91|
71760756|NCT04603027|143022890|SUPERIORITY||Posterior Mean difference|-3.33|||||TWO_SIDED|95.0|-15.21|8.52||||||||8.52|-15.21|
71760757|NCT04603027|143022890|SUPERIORITY||Posterior Mean difference|0.11|||||TWO_SIDED|95.0|-12.33|11.53||||||||11.53|-12.33|
71760758|NCT04603027|143022891|SUPERIORITY||Posterior Mean difference|-0.69|||||TWO_SIDED|95.0|-1.88|0.46||||||||0.46|-1.88|
71760759|NCT04603027|143022891|SUPERIORITY||Posterior Mean difference|-0.73|||||TWO_SIDED|95.0|-1.82|0.45||||||||0.45|-1.82|
71760760|NCT04603027|143022891|SUPERIORITY||Posterior Mean difference|-0.81|||||TWO_SIDED|95.0|-2.05|0.33||||||||0.33|-2.05|
71760761|NCT04603027|143022892|SUPERIORITY||Odds Ratio (OR)|2.64|||||TWO_SIDED|95.0|1.01|6.94||||||||6.94|1.01|
71760762|NCT04603027|143022892|SUPERIORITY||Odds Ratio (OR)|2.93|||||TWO_SIDED|95.0|1.17|7.37||||||||7.37|1.17|
71760763|NCT04603027|143022892|SUPERIORITY||Odds Ratio (OR)|1.73|||||TWO_SIDED|95.0|0.63|4.7||||||||4.70|0.63|
71760764|NCT04603027|143022893|SUPERIORITY|||||||0.1|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.100
71760765|NCT04603027|143022893|SUPERIORITY|||||||0.034|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.034
71760766|NCT04603027|143022893|SUPERIORITY|||||||0.094|||||||nonparametric survival analysis|Method used was a nonparametric survival analysis for interval censored data||||||0.094
71760767|NCT04603027|143022897|SUPERIORITY||Posterior Mean Odds Ratio|2.14|||||TWO_SIDED|95.0|0.45|10.96||||||||10.96|0.45|
71760768|NCT04603027|143022897|SUPERIORITY||Posterior Mean Odds Ratio|2.02|||||TWO_SIDED|95.0|0.42|8.78||||||||8.78|0.42|
71760769|NCT04603027|143022897|SUPERIORITY||Posterior Mean Odds Ratio|2.12|||||TWO_SIDED|95.0|0.46|9.51||||||||9.51|0.46|
71760770|NCT04603027|143022898|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
71760771|NCT04603027|143022898|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
71760772|NCT04603027|143022898|SUPERIORITY||||||||||||||||||There were not enough responders to model using GLMM or a Bayesian logistic model, and no treatment difference analysis was conducted.|||
71760773|NCT04603027|143022899|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
71760774|NCT04603027|143022899|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
71760775|NCT04603027|143022899|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
71760776|NCT04603027|143022900|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
71760777|NCT04603027|143022900|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
71760778|NCT04603027|143022900|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
71760779|NCT04603027|143022901|SUPERIORITY||Posterior Mean difference|-9.08|||||TWO_SIDED|95.0|-30.22|12.4||||||||12.40|-30.22|
71760780|NCT04603027|143022901|SUPERIORITY||Posterior Mean difference|-2.99|||||TWO_SIDED|95.0|-23.41|18.15||||||||18.15|-23.41|
71760781|NCT04603027|143022901|SUPERIORITY||Posterior Mean difference|-17.1|||||TWO_SIDED|95.0|-38.29|3.25||||||||3.25|-38.29|
71760782|NCT04603027|143022902|SUPERIORITY||Posterior Mean difference|-2.66|||||TWO_SIDED|95.0|-6.79|1.52||||||||1.52|-6.79|
71760783|NCT04603027|143022902|SUPERIORITY||Posterior Mean difference|-0.83|||||TWO_SIDED|95.0|-4.7|3.16||||||||3.16|-4.70|
71760784|NCT04603027|143022902|SUPERIORITY||Posterior Mean difference|-3.53|||||TWO_SIDED|95.0|-7.49|0.63||||||||0.63|-7.49|
71760785|NCT04603027|143022903|SUPERIORITY||Posterior Mean difference|2.99|||||TWO_SIDED|95.0|-19.99|28.84||||||||28.84|-19.99|
71760786|NCT04603027|143022903|SUPERIORITY||Posterior Mean difference|-2.49|||||TWO_SIDED|95.0|-26.47|21.55||||||||21.55|-26.47|
71760787|NCT04603027|143022903|SUPERIORITY||Posterior Mean difference|13.36|||||TWO_SIDED|95.0|-12.03|36.92||||||||36.92|-12.03|
71760788|NCT04603027|143022904|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
71760789|NCT04603027|143022904|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
71760790|NCT04603027|143022904|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
71760791|NCT04603027|143022905|SUPERIORITY||Posterior Mean difference|13.71|||||TWO_SIDED|95.0|-50.62|73.35||||||||73.35|-50.62|
71760792|NCT04603027|143022905|SUPERIORITY||Posterior Mean difference|73.69|||||TWO_SIDED|95.0|21.69|126.92||||||||126.92|21.69|
71760793|NCT04603027|143022905|SUPERIORITY||Posterior Mean difference|8.41|||||TWO_SIDED|95.0|-44.58|56.81||||||||56.81|-44.58|
71760794|NCT04603027|143022906|SUPERIORITY||Posterior Mean difference|0.62|||||TWO_SIDED|95.0|-1.1|2.3||||||||2.30|-1.10|
71760795|NCT04603027|143022906|SUPERIORITY||Posterior Mean difference|-0.21|||||TWO_SIDED|95.0|-1.96|1.37||||||||1.37|-1.96|
71760796|NCT04603027|143022906|SUPERIORITY||Posterior Mean difference|-0.08|||||TWO_SIDED|95.0|-1.73|1.75||||||||1.75|-1.73|
71760797|NCT03284307|143022922|SUPERIORITY||Slope|0.11|STANDARD_ERROR_OF_MEAN|0.043||0.012|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Dexmedetomidine, Unconsciousness vs Disconnected Consciousness||||0.012
71760798|NCT03284307|143022922|SUPERIORITY||Slope|-0.238|STANDARD_ERROR_OF_MEAN|0.199||0.236|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Ketamine, Unconsciousness vs Disconnected Consciousness||||0.236
71760799|NCT03284307|143022922|SUPERIORITY||Slope|0.166|STANDARD_ERROR_OF_MEAN|0.12||0.174|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Propofol, Unconsciousness vs Disconnected Consciousness||||0.174
71760800|NCT03284307|143022922|SUPERIORITY||Slope|0.052|STANDARD_ERROR_OF_MEAN|0.111||0.64|TWO_SIDED|||||Statistical significance defined by p \< 0.05.|Mixed Models Analysis||Estimate is a slope from a linear mixed effects model representing the difference in occipital delta power between unconsciousness and disconnected consciousness after adjusting for within-subject effects.|Sleep, Unconsciousness vs Disconnected Consciousness||||0.640
71760801|NCT03284307|143022924|SUPERIORITY|||||||0.134||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Card Sorting Score||||0.134
71760802|NCT03284307|143022924|SUPERIORITY|||||||0.012||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Card Sorting Score||||0.012
71760803|NCT03284307|143022924|SUPERIORITY|||||||0.487||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|1 degree of freedom||NIH Toolbox Card Sorting Score||||0.487
71760804|NCT03284307|143022924|SUPERIORITY|||||||0.046||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|3 degrees of freedom||NIH Toolbox Flanker Score||||0.046
71760805|NCT03284307|143022924|SUPERIORITY|||||||0.01||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|6 degrees of freedom||NIH Toolbox Flanker Score||||0.010
71760806|NCT03284307|143022924|SUPERIORITY|||||||0.356||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|||NIH Toolbox Flanker Score||||0.356
71760807|NCT03284307|143022925|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
71760808|NCT03284307|143022925|SUPERIORITY||||||<|0.001||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|14 degrees of freedom||Predictive Coding Task Accuracy||||<0.001
71760809|NCT03284307|143022925|SUPERIORITY|||||||0.067||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Predictive Coding Task Accuracy||||0.067
71760810|NCT03284307|143022926|SUPERIORITY|||||||0.5||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|17 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.5
71760811|NCT03284307|143022926|SUPERIORITY|||||||0.37||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|11 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.37
71760812|NCT03284307|143022926|SUPERIORITY|||||||0.12||||||Statistical significance defined by p \< 0.05.|t-test, 2 sided|4 degrees of freedom||Null hypothesis is a 50% recall rate.||||0.12
71760813|NCT03249116|143022979|SUPERIORITY||F statistic|0.33||||0.723|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: self-reported anxiety between-subjects factors: condition, social anxiety within-subjects factor: time||||||.723
71760814|NCT03249116|143022980|SUPERIORITY||F statistic|1.34||||0.271|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: electrodermal activity between-subjects factors: condition, social anxiety within-subjects factor: time||||||.271
71760815|NCT03249116|143022981|SUPERIORITY||F statistic|0.45||||0.638|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: heart rate between-subjects factors: condition, social anxiety within-subjects factor: time||||||.638
71760816|NCT03249116|143022982|SUPERIORITY||F statistic|0.14||||0.868|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: number of errors between-subjects factors: condition, social anxiety||||||.868
71760817|NCT03249116|143022983|SUPERIORITY||F statistic|0.21||||0.809|TWO_SIDED|||||The threshold for statistical significance was p\<.05|ANOVA|dependent variable: lowest number reached/highest number of correct responses between-subjects factors: condition, social anxiety||||||.809
71760818|NCT00221117|143022984|OTHER|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||||||.015
71760819|NCT00221117|143022985|SUPERIORITY_OR_OTHER|||||||0.05|TWO_SIDED|95.0|||||Regression, Linear|||The subject's impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann-Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).||||0.05
71760820|NCT03682770|143023015|SUPERIORITY||Difference in percentage|20.23||||0.042|TWO_SIDED|95.0|1.266|39.189||The p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by screening peanut-specific IgE level and baseline body weight.|Cochran-Mantel-Haenszel||Difference in percentage derived by Mantel-Haenszel (MH) method|||39.189|1.266|0.0420
71760821|NCT03682770|143023016|SUPERIORITY||Least Square Mean Difference|0.67||||0.04|TWO_SIDED|95.0|0.031|1.305||P-value is based on treatment difference (dupilumab + AR101 vs placebo + AR101) of the LS mean change using analysis of covariance (ANCOVA) model.|ANCOVA|||||1.305|0.031|0.0400
71760822|NCT03682770|143023017|SUPERIORITY||Difference in percentage|11.91||||0.0806|TWO_SIDED|95.0|-3.612|27.44||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kilo allergy unit per liter \[kUA/L\] vs \>100 kUA/L) and body weight (\<30 kg, \>=30 and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||27.440|-3.612|0.0806
71760823|NCT03682770|143023019|SUPERIORITY||Difference in percentage|10.4||||0.353|TWO_SIDED|95.0|-11.668|32.474||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||32.474|-11.668|0.3530
71760824|NCT03682770|143023020|SUPERIORITY||Least Square Mean Difference|0.37||||0.2628|TWO_SIDED|95.0|-0.281|1.029||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||1.029|-0.281|0.2628
71760825|NCT03682770|143023021|SUPERIORITY||Difference in percentage|-2.36||||0.814|TWO_SIDED|95.0|-25.004|20.282||P-values were derived by CMH test stratified by screening peanut-specific IgE level (\<=100 kUA/L vs \>100 kUA/L) and baseline body weight (\<30 kg, \>=30 kg and \<60 kg, or \>=60 kg).|Cochran-Mantel-Haenszel||Difference in percentage derived by MH method|||20.282|-25.004|0.8140
71760826|NCT03682770|143023022|SUPERIORITY||Least Square Mean Difference|-0.05||||0.8805|TWO_SIDED|95.0|-0.699|0.599||P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.|ANCOVA|||||0.599|-0.699|0.8805
71760827|NCT03682770|143023024|SUPERIORITY||Difference percentage|-85.55|||<|0.0001|TWO_SIDED|95.0|-99.47|-73.91||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate,- and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-73.91|-99.47|<0.0001
71760828|NCT03682770|143023025|SUPERIORITY||Difference in percentage|-68.78|||<|0.0001|TWO_SIDED|95.0|-86.71|-56.4||P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate, and stratification factors and the treatment as fixed factors.|ANCOVA||Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.|||-56.40|-86.71|<0.0001
71760829|NCT02362282|143023026|SUPERIORITY|||||||0.54|||||||t-test, 2 sided|||||||0.54
71760830|NCT03599089|143023028|SUPERIORITY|||||||0.005|||||||ANOVA|||||||0.005
71760831|NCT03599089|143023029|SUPERIORITY|||||||0.0245|||||||Regression, Logistic|||||||0.0245
71760832|NCT03599089|143023030|SUPERIORITY|||||||0.0019|||||||ANOVA|||||||0.0019
71760833|NCT02289157|143023047|OTHER||Risk Ratio (RR)|0.9||||0.54|TWO_SIDED|95.0|0.5|1.4|||Regression, Logistic|Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.||||1.4|0.5|0.54
71760834|NCT02289157|143023048|OTHER|||||||0.31|||||||Chi-squared|Pearson Chi-squared, df (3)||Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.||||0.31
71760835|NCT02289157|143023049|OTHER|||||||0.54||||||Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.|Wilcoxon (Mann-Whitney)|||||||0.54
71760836|NCT02289157|143023050|OTHER|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.||||0.41
71760837|NCT02289157|143023051|OTHER|||||||0.38|||||||Chi-squared|||Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.||||0.38
71760838|NCT02289157|143023052|OTHER|||||||0.48||||||Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.|Chi-squared|||||||0.48
71760839|NCT02289157|143023053|OTHER|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.||||0.52
71760840|NCT02289157|143023053|OTHER|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.||||0.45
71760841|NCT02289157|143023053|OTHER|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.||||0.44
71760842|NCT02289157|143023054|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing||||||0.68||||||Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.|Cochran-Mantel-Haenszel|||||||0.68
71760843|NCT02289157|143023055|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing||||||0.27|||||||Cochran-Mantel-Haenszel|||||||0.27
71760844|NCT02289157|143023056|OTHER|Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing||||||0.55|||||||Cochran-Mantel-Haenszel|||||||0.55
71760845|NCT02289157|143023057|OTHER|Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing||||||0.49|||||||Cochran-Mantel-Haenszel|||||||0.49
71760846|NCT02289157|143023058|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity||||||0.92|||||||Cochran-Mantel-Haenszel|||||||0.92
71760847|NCT02289157|143023059|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.||||||0.22|||||||Cochran-Mantel-Haenszel|||||||0.22
71760848|NCT02289157|143023060|OTHER|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity||||||0.74|||||||Cochran-Mantel-Haenszel|||||||0.74
71760849|NCT00976560|143023066|SUPERIORITY_OR_OTHER||Mean Difference (Net)|-0.6|STANDARD_DEVIATION|0.99|||TWO_SIDED|95.0|-2.54|1.35|||BMMRM|Bayesian Mixed Effects Model Repeated Measures (BMMRM)|Prior distribution of N(-4.1, 6.4009) incorporated into the posterior for the treatment difference at Week 6. The presented Confidence Interval is Highest Probability Density (HPD).||Posterior probability of the treatment difference being greater than 1.6 points in favor of GW856553 7.5mg BID as compared to placebo at Week 6 is 15.46 and for 0 is 72.98 and for 2 is 7.87.|1.35|-2.54|
71760850|NCT00125164|143023089|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.79|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.19|2.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.39|1.19|<0.0001
71760851|NCT00125164|143023089|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.58|STANDARD_ERROR_OF_MEAN|0.3|<|0.0001||95.0|1.99|3.16||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.16|1.99|< 0.0001
71760852|NCT00125164|143023089|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.79|STANDARD_ERROR_OF_MEAN|0.26||0.0032||95.0|0.27|1.31|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.31|0.27|0.0032
71760853|NCT00125164|143023090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.07|<|0.0001||95.0|0.24|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.24|< 0.0001
71760854|NCT00125164|143023090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.47|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.34|0.6||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.60|0.34|< 0.0001
71760855|NCT00125164|143023090|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.11|STANDARD_ERROR_OF_MEAN|0.05||0.0495||95.0|0.0|0.22|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.22|0.00|0.0495
71760856|NCT00125164|143023098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|1.26|2.4||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||2.40|1.26|<0.0001
71760857|NCT00125164|143023098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|2.83|STANDARD_ERROR_OF_MEAN|0.29|<|0.0001||95.0|2.26|3.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||3.39|2.26|<0.0001
71760858|NCT00125164|143023098|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|1.01|STANDARD_ERROR_OF_MEAN|0.25||0.0002||95.0|0.5|1.51|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||1.51|0.50|0.0002
71760859|NCT00125164|143023099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.37|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.25|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.50|0.25|<0.0001
71760860|NCT00125164|143023099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.52|STANDARD_ERROR_OF_MEAN|0.06|<|0.0001||95.0|0.39|0.64||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett's method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.64|0.39|<0.0001
71760861|NCT00125164|143023099|SUPERIORITY_OR_OTHER_LEGACY||LS mean difference|0.15|STANDARD_ERROR_OF_MEAN|0.06||0.0071||95.0|0.04|0.26|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.||0.26|0.04|0.0071
71760862|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.93|
71760863|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.96|1.01||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.01|0.96|
71760864|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.94|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.00|0.94|
71760865|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
71760866|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.06|0.96|
71760867|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.0|||||TWO_SIDED|90.0|0.93|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.07|0.93|
71760868|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.05|||||TWO_SIDED|90.0|0.99|1.11||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.11|0.99|
71760869|NCT02637037|143023115|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.03|||||TWO_SIDED|90.0|0.96|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.96|
71760870|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.94|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||0.99|0.94|
71760871|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||TWO_SIDED|90.0|0.97|1.02||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.02|0.97|
71760872|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||TWO_SIDED|90.0|0.93|0.98||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||0.98|0.93|
71760873|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.00|0.95|
71760874|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.97|1.08||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.08|0.97|
71760875|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.95|
71760876|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.03|||||TWO_SIDED|90.0|0.97|1.09||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.09|0.97|
71760877|NCT02637037|143023116|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.95|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.07|0.95|
71760878|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.93|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.03|0.93|
71760879|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.9|1.06||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.06|0.90|
71760880|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||TWO_SIDED|90.0|0.89|1.05||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.05|0.89|
71760881|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.95|||||TWO_SIDED|90.0|0.87|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.03|0.87|
71760882|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||TWO_SIDED|90.0|0.96|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.||1.07|0.96|
71760883|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||TWO_SIDED|90.0|0.92|1.04||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.||1.04|0.92|
71760884|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.0|||||TWO_SIDED|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.||1.06|0.95|
71760885|NCT02637037|143023117|NON_INFERIORITY_OR_EQUIVALENCE|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||TWO_SIDED|90.0|0.94|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.||1.10|0.94|
71760886|NCT01354314|143023194|SUPERIORITY|||||||0.893|||||||Regression, Linear|||||||0.893
71760887|NCT01354314|143023194|SUPERIORITY|||||||0.594|||||||Regression, Linear|||||||0.594
71760888|NCT01354314|143023194|SUPERIORITY|||||||0.712|||||||Regression, Linear|||||||0.712
71760889|NCT01354314|143023195|SUPERIORITY|||||||0.673|||||||Regression, Linear|||||||0.673
71760890|NCT01354314|143023195|SUPERIORITY|||||||0.153|||||||Regression, Linear|||||||0.153
71760891|NCT01354314|143023195|SUPERIORITY|||||||0.282|||||||Regression, Linear|||||||0.282
71760892|NCT01354314|143023196|SUPERIORITY|||||||0.327|||||||Regression, Linear|||||||0.327
71760893|NCT01354314|143023196|SUPERIORITY|||||||0.178|||||||Regression, Linear|||||||0.178
71760894|NCT01354314|143023196|SUPERIORITY|||||||0.48|||||||Regression, Linear|||||||0.480
71760895|NCT01354314|143023197|SUPERIORITY|||||||0.267|||||||Regression, Linear|||||||0.267
71760896|NCT01354314|143023197|SUPERIORITY|||||||0.368|||||||Regression, Linear|||||||0.368
71760897|NCT01354314|143023197|SUPERIORITY|||||||0.672|||||||Regression, Linear|||||||0.672
71760898|NCT00478023|143023226|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|18.1|||<|0.0001||95.0|10.9|25.3||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||25.3|10.9|<0.0001
71760899|NCT00478023|143023226|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.8|||<|0.0001||95.0|13.7|28.0||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||28.0|13.7|<0.0001
71760900|NCT00478023|143023226|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|23.3|||<|0.0001||95.0|16.3|30.4||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.||30.4|16.3|<0.0001
71760901|NCT00478023|143023226|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|20.6|||<|0.0001||95.0|13.4|27.8||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||27.8|13.4|<0.0001
71760902|NCT00478023|143023227|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|37.1|||<|0.0001||95.0|21.6|52.6||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||52.6|21.6|<0.0001
71760903|NCT00478023|143023227|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|44.0|||<|0.0001||95.0|28.6|59.5||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariates.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||59.5|28.6|<0.0001
71760904|NCT00478023|143023227|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|51.4|||<|0.0001||95.0|36.1|66.7||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA||Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.||66.7|36.1|<0.0001
71760905|NCT00478023|143023227|SUPERIORITY_OR_OTHER_LEGACY||Least square mean difference|46.9|||<|0.0001||95.0|31.4|62.4||No multiplicity adjustment.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as a covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.||62.4|31.4|<0.0001
71760906|NCT02453711|143023232|OTHER||Treatment difference (%-points)|-3.7|STANDARD_ERROR_OF_MEAN|1.13|=|0.0055|TWO_SIDED|95.0|-6.55|-0.85|||ANCOVA||Semaglutide 0.05 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-0.85|-6.55|=0.0055
71760907|NCT02453711|143023232|OTHER||Treatment difference (%-points)|-6.32|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-9.16|-3.49|||ANCOVA||Semaglutide 0.1 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-3.49|-9.16|<0.0001
71760908|NCT02453711|143023232|OTHER||Treatment difference (%-points)|-9.31|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-12.15|-6.46|||ANCOVA||Semaglutide 0.2 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.46|-12.15|<0.0001
71760909|NCT02453711|143023232|OTHER||Treatment difference (%-points)|-8.88|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-11.72|-6.03|||ANCOVA||Semaglutide 0.3 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-6.03|-11.72|<0.0001
71760910|NCT02453711|143023232|OTHER||Treatment difference (%-points)|-11.55|STANDARD_ERROR_OF_MEAN|1.12|<|0.0001|TWO_SIDED|95.0|-14.38|-8.72|||ANCOVA||Semaglutide 0.4 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett's method was used to adjust for multiple comparisons.||-8.72|-14.38|<0.0001
71760911|NCT01600170|143023274|SUPERIORITY|||||||0.39||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.39
71760912|NCT01600170|143023275|SUPERIORITY||||||<|0.45||||||Threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||<0.45
71760913|NCT01600170|143023276|SUPERIORITY|||||||0.8||||||The threshold for statistical significance was p = 0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.80
71760914|NCT01600170|143023277|SUPERIORITY|||||||0.04||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.04
71760915|NCT01600170|143023278|SUPERIORITY|||||||0.15||||||The threshold of statistical significance was p=0.01|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Primary outcomes were pre-specified to use p\<0.01 for statistical significance. All other analyses used p\<0.05 after adjustment for multiple comparisons.||||0.15
71761180|NCT00611026|143024038|SUPERIORITY_OR_OTHER||Mean Difference (Final Values)|-0.2|STANDARD_ERROR_OF_MEAN|0.1||0.0944|TWO_SIDED|95.0|-0.4|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.||0.0|-0.4|0.0944
71760916|NCT01600170|143023279|SUPERIORITY|||||||0.63||||||The threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.63
71760917|NCT01600170|143023280|SUPERIORITY|||||||0.035||||||Threshold for statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.035
71760918|NCT01600170|143023281|SUPERIORITY|||||||0.62||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.62
71760919|NCT01600170|143023282|SUPERIORITY|||||||0.99||||||The threshold of statistical significance was p = 0.05|Mixed Models Analysis|||Analysis focused on a comparison of change in response over 12 wks for each treatment under a 2x2 crossover design. Mixed effects model was used to estimate within subject treatment differences, trends over time \& at each wk(0,2,6,12). Log-transformations were applied to meet normality assumption \& models adjusted for period \& sequence effects. Secondary outcome analyses used p\<0.05 for statistical significance after adjustment for multiple comparisons.||||0.99
71760920|NCT01209325|143023285|SUPERIORITY|||||||0.112||||||Two-sided p-value|Exact poisson test|||||||0.112
71760921|NCT01209325|143023285|SUPERIORITY|||||||0.447||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively.||||0.447
71760922|NCT01209325|143023286|SUPERIORITY|||||||0.224||||||Two-sided p-value.|Exact poisson test|||||||0.224
71760923|NCT01209325|143023286|SUPERIORITY|One-sided p-value.||||||0.361|||||||Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively.||||0.361
71760924|NCT01209325|143023287|SUPERIORITY|||||||0.079||||||Two-sided p-value.|Exact poisson test|||||||0.079
71760925|NCT01209325|143023287|SUPERIORITY|||||||0.35||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.||||0.350
71760926|NCT01209325|143023288|SUPERIORITY|||||||0.162|||||||Exact poisson test|||||||0.162
71760927|NCT01209325|143023288|SUPERIORITY|||||||0.49||||||One-sided p-value|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.||||0.490
71760928|NCT01209325|143023289|SUPERIORITY|||||||0.671||||||Two-sided p-value is comparing naive and prior exposure groups for HPV 6.|Exact Poisson calculation|||||||0.671
71760929|NCT01209325|143023289|SUPERIORITY|||||||0.312||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.||||0.312
71760930|NCT01209325|143023290|SUPERIORITY||||||>|0.999||||||Two-sided p-value.|Exact Poisson calculation|||||||>0.999
71760931|NCT01209325|143023290|SUPERIORITY|||||||0.209||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively.||||0.209
71760932|NCT01209325|143023291|SUPERIORITY|||||||0.386||||||Two-sided p-value.|Exact Poisson calculation|||||||0.386
71760933|NCT01209325|143023291|SUPERIORITY|||||||0.305||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively.||||0.305
71760934|NCT01209325|143023292|SUPERIORITY|||||||0.622||||||Two-sided p-value.|Exact Poisson calculation|||||||0.622
71760935|NCT01209325|143023292|SUPERIORITY|||||||0.15||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively.||||0.150
71760936|NCT01209325|143023293|SUPERIORITY|||||||0.064||||||Two-sided p-value.|Exact Poisson calculation|||||||0.064
71760937|NCT01209325|143023294|SUPERIORITY|||||||0.745||||||Two-sided test.|Exact Poisson calculation|||||||0.745
71760938|NCT01209325|143023295|SUPERIORITY|||||||0.014|||||||Exact Poisson calculation|||||||0.014
71760939|NCT01209325|143023296|SUPERIORITY|||||||0.166||||||Two-sided p-value.|Exact Poisson calculation|||||||0.166
71760940|NCT01209325|143023297|SUPERIORITY|||||||0.789||||||Two-sided p-value.|Exact Poisson calculation|||||||0.789
71760941|NCT01209325|143023298|SUPERIORITY|||||||0.809||||||Two-sided p-value.|0.809|||||||0.809
71760942|NCT01209325|143023299|SUPERIORITY|||||||0.422||||||Two-sided p-value.|Exact Poisson calculation|||||||0.422
71760943|NCT01209325|143023300|SUPERIORITY|||||||0.423||||||Two-sided p-value.|Exact Poisson calculation|||||||0.423
71760944|NCT05340478|143023325|SUPERIORITY||||||<|0.001|||||||t-test, 2 sided|||||||<.001
71760945|NCT00092443|143023332|SUPERIORITY_OR_OTHER||Efficacy = 1-Relative Risk|72.5|||<|0.001||95.0|50.6|85.6|||Exact Binomial Test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|||85.6|50.6|<0.001
71760946|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|56.7||||||95.0|44.0|66.8||||||||66.8|44.0|
71760947|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|2.7||||||95.0|0.3|9.5||||||||9.5|0.3|
71760948|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|14.5||||||95.0|6.9|25.8||||||||25.8|6.9|
71760949|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|5.1||||||||5.1|0.0|
71760950|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|9.0||||||95.0|3.4|18.5||||||||18.5|3.4|
71760951|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|0.0||||||95.0|0.0|4.8||||||||4.8|0.0|
71760952|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|39.7||||||95.0|27.6|52.8||||||||52.8|27.6|
71760953|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|1.4||||||95.0|0.0|7.7||||||||7.7|0.0|
71760954|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|24.6||||||95.0|14.5|37.3||||||||37.3|14.5|
71760955|NCT00092443|143023333|SUPERIORITY_OR_OTHER||Percent of Participants|2.9||||||95.0|0.4|10.1||||||||10.1|0.4|
71760956|NCT04555616|143023359|OTHER|||||||0.12|||||||Fisher Exact|||Primary outcome analyzed via success rates among groups.||||0.12
71760957|NCT04816669|143023362|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.|Geometric mean ratio|0.68|||||TWO_SIDED|95.0|0.6|0.77|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 lyophilized SDV - BNT162b2 frozen-liquid MDV and the corresponding CI (based on the Student t distribution).|||0.77|0.60|
71760958|NCT04816669|143023370|NON_INFERIORITY|Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67|Geometric mean ratio|1.14|||||TWO_SIDED|95.0|0.77|1.68|||||GMRs and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the concentrations BNT162b2 frozen-liquid LNP - BNT162b2 frozen-liquid RTU and the corresponding CI (based on the Student t distribution).|||1.68|0.77|
71760959|NCT01229267|143023378|SUPERIORITY||Vaccine Efficacy|0.638|||||TWO_SIDED|95.0|0.484|0.746|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is \>0.25.||0.746|0.484|
71760960|NCT01229267|143023379|OTHER||Vaccine Efficacy|0.695|||||TWO_SIDED|95.0|0.49|0.818|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.818|0.490|
71760961|NCT01229267|143023380|OTHER||Vaccine Efficacy|0.735|||||TWO_SIDED|95.0|0.498|0.86|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.860|0.498|
71760962|NCT01229267|143023381|OTHER||Vaccine Efficacy|0.837|||||TWO_SIDED|95.0|0.446|0.952|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \>0.25.||0.952|0.446|
71760963|NCT01229267|143023382|OTHER||Risk Difference (RD)|0.2||||0.942|TWO_SIDED|95.0|-5.1|5.5|||Normal approximation||Miettinen \& Nurminen|||5.5|-5.1|0.942
71760964|NCT02446899|143023384|SUPERIORITY|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).|Mean Difference (Final Values)|16.3||||0.0013|TWO_SIDED|95.0|6.3|26.3||Nominal p-value.|Cochran-Mantel-Haenszel|||||26.3|6.3|0.0013
71760965|NCT02446899|143023385|SUPERIORITY||Mean Difference (Final Values)|17.3||||0.0022|TWO_SIDED|95.0|6.5|28.2||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||28.2|6.5|0.0022
71760966|NCT02446899|143023386|SUPERIORITY||Mean Difference (Final Values)|21.2||||0.0135|TWO_SIDED|95.0|6.8|35.7||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||35.7|6.8|0.0135
71760967|NCT02446899|143023387|SUPERIORITY||Mean Difference (Final Values)|24.0||||0.0392|TWO_SIDED|95.0|4.3|43.6||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||43.6|4.3|0.0392
71760968|NCT02446899|143023388|SUPERIORITY||Mean Difference (Final Values)|4.7||||0.5469|TWO_SIDED|95.0|-10.6|20.0||Adjusted p-value|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>= 10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]).||20.0|-10.6|0.5469
71760969|NCT02446899|143023389|SUPERIORITY||Rate Ratio|0.67||||0.0809|TWO_SIDED|95.0|0.48|0.94||Adjusted p-value.|Negative binomial regression|||Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening \[\<10 points vs \>=10 points\], Week 0 OCS dose \[\<10 mg/day vs \>=10 mg/day prednisone or equivalent\] and type I IFN gene signature test result at screening \[high vs low\]). The logarithm of the follow-up time is used as an offset variable.||0.94|0.48|0.0809
71760970|NCT04050202|143023394|OTHER||Mean Difference (Net)|8.45|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score.|||||<0.01
71760971|NCT04050202|143023395|OTHER||Mean Difference (Net)|13.97|||<|0.01|TWO_SIDED||||||t-test, 2 sided||The post-intervention score is subtracted from the baseline score|||||<0.01
71760972|NCT01499277|143023396|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations.|Risk Difference (RD)|-0.95|||||TWO_SIDED|95.0|-6.9|5.41||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam). CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||5.41|-6.9|
71760973|NCT01499277|143023397|NON_INFERIORITY_OR_EQUIVALENCE|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was \>0%.|Risk Difference (RD)|1.27|||||TWO_SIDED|95.0|-4.32|7.48||||RD is the difference in clinical cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.||7.48|-4.32|
71760974|NCT01499277|143023398|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.71|||||TWO_SIDED|95.0|-6.21|10.39||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||10.39|-6.21|
71760975|NCT01499277|143023399|SUPERIORITY_OR_OTHER||Risk Difference (RD)|4.77|||||TWO_SIDED|95.0|-2.11|12.86||||RD is the difference in favorable rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||12.86|-2.11|
71760976|NCT01499277|143023400|SUPERIORITY_OR_OTHER||Risk Difference (RD)|1.25|||||TWO_SIDED|95.0|-4.05|7.06||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||7.06|-4.05|
71760977|NCT01499277|143023401|SUPERIORITY_OR_OTHER||Risk Difference (RD)|2.92|||||TWO_SIDED|95.0|-2.19|8.73||||RD is the difference in cure rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||8.73|-2.19|
71760978|NCT01499277|143023402|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-0.79|||||TWO_SIDED|95.0|-3.98|1.18||||RD is the difference in relapse rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||1.18|-3.98|
71760979|NCT01499277|143023403|SUPERIORITY_OR_OTHER||Risk Difference (RD)|-1.86|||||TWO_SIDED|95.0|-6.34|3.15||||RD is the difference in success rates (Ceftaroline minus Vancomycin/Aztreonam).CI was calculated by unstratified Miettinen and Nurminen CI.|CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|||3.15|-6.34|
71760980|NCT02974543|143023405|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71760981|NCT02974543|143023406|SUPERIORITY||||||<|0.05|||||||Mixed Models Analysis|||||||<0.05
71760982|NCT04730271|143023428|NON_INFERIORITY|Test of non-inferiority: Absolute value deviation from plan with ROBOTIC is less than it is with manual instruments (not using ROBOTIC) under a non-inferiority margin of 1.5 degrees|||||<|0.0001|||||||t-test, 1 sided|||||||<0.0001
71760983|NCT04730271|143023429|SUPERIORITY|||||||0.0058|||||||t-test, 2 sided|||||||0.0058
71760984|NCT04730271|143023430|SUPERIORITY|||||||0.0282|||||||t-test, 2 sided|||||||0.0282
71760985|NCT04730271|143023431|SUPERIORITY|||||||0.0004|||||||t-test, 2 sided|||||||0.0004
71760986|NCT04730271|143023432|SUPERIORITY||||||<|0.0001|||||||t-test, 2 sided|||||||<0.0001
71760987|NCT04730271|143023433|SUPERIORITY|||||||0.633|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 1 year of the procedure.||||0.6330
71760988|NCT04730271|143023433|SUPERIORITY|||||||0.04|||||||Fisher Exact|||Comparison between the proportion of Robotic and Manual subjects who had a serious local adverse event within 1 year of the procedure.||||0.0400
71760989|NCT04730271|143023433|SUPERIORITY|||||||0.4079|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local adverse event within 90 days of the procedure.||||0.4079
71760990|NCT04730271|143023433|SUPERIORITY|||||||0.1262|||||||Chi-squared|||Comparison between the proportion of Robotic and Manual subjects who had a local serious adverse event within 90 days of the procedure.||||0.1262
71760991|NCT04730271|143023435|SUPERIORITY|||||||0.6662|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.6662
71760992|NCT04730271|143023435|SUPERIORITY|||||||0.8154|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8154
71760993|NCT04730271|143023436|SUPERIORITY|||||||0.0165|||||||t-test, 2 sided|||Comparison of FJS at 12 weeks||||0.0165
71760994|NCT04730271|143023436|SUPERIORITY|||||||0.1331|||||||t-test, 2 sided|||Comparison of FJS at 1 year||||0.1331
71760995|NCT04730271|143023437|SUPERIORITY|||||||0.1596|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.1596
71760996|NCT04730271|143023437|SUPERIORITY|||||||0.6834|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6834
71760997|NCT04730271|143023438|SUPERIORITY|||||||0.5675|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.5675
71760998|NCT04730271|143023438|SUPERIORITY|||||||0.924|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9240
71760999|NCT04730271|143023439|SUPERIORITY|||||||0.4586|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4586
71761000|NCT04730271|143023439|SUPERIORITY|||||||0.6951|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.6951
71761001|NCT04730271|143023440|SUPERIORITY|||||||0.8|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.8000
71761002|NCT04730271|143023440|SUPERIORITY|||||||0.973|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.9730
71761003|NCT04730271|143023441|SUPERIORITY|||||||0.4636|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 1 year||||0.4636
71761004|NCT04730271|143023441|SUPERIORITY|||||||0.8088|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL at 12 weeks||||0.8088
71761005|NCT04730271|143023442|SUPERIORITY|||||||0.4851|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 12 weeks||||0.4851
71761006|NCT04730271|143023442|SUPERIORITY|||||||0.6486|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL at 1 year||||0.6486
71761007|NCT04730271|143023443|SUPERIORITY|||||||0.8887|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for Pain at rest between ROBOTIC and MANUAL at 1 year||||0.8887
71761008|NCT04730271|143023443|SUPERIORITY|||||||0.4007|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline for pain at rest between ROBOTIC and MANUAL at 12 weeks||||0.4007
71761009|NCT04730271|143023443|SUPERIORITY|||||||0.0074|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for pain at rest at 12 weeks||||0.0074
71761010|NCT04730271|143023443|SUPERIORITY|||||||0.0663|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain at rest at 1 year||||0.0663
71761011|NCT04730271|143023443|SUPERIORITY|||||||0.7096|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for Pain with Activity at 1 year||||0.7096
71761012|NCT04730271|143023443|SUPERIORITY|||||||0.5321|||||||t-test, 2 sided|||T-test P-value for difference in change from baseline between ROBOTIC and MANUAL for pain with activity at 12 weeks||||0.5321
71761013|NCT04730271|143023443|SUPERIORITY|||||||0.0709|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 12 weeks||||0.0709
71761014|NCT04730271|143023443|SUPERIORITY|||||||0.1274|||||||t-test, 2 sided|||T-Test P-value tests the significance of the difference between ROBOTIC and MANUAL for Pain with activity at 1 year||||0.1274
71761015|NCT04730271|143023444|SUPERIORITY|||||||0.6745|||||||t-test, 2 sided|||Comparison between the accuracy achieved in the first 10 cases compared to the subsequent cases||||0.6745
71761016|NCT02688777|143023466|SUPERIORITY||Hazard Ratio, log|0.6|||||TWO_SIDED|||||||||||||
71761017|NCT02688777|143023467|SUPERIORITY||Mean Difference (Final Values)|0.05|STANDARD_ERROR_OF_MEAN|0.03||0.37|TWO_SIDED|||||A priori threshold for significance is p \< 0.05.|t-test, 2 sided|||||||0.37
71761018|NCT02688777|143023468|SUPERIORITY||Mean Difference (Final Values)|0.16|STANDARD_ERROR_OF_MEAN|0.02||0.13|TWO_SIDED|||||A priori threshold set for p \< 0.05|t-test, 2 sided|||||||0.13
71761019|NCT02688777|143023469|SUPERIORITY||Mean Difference (Final Values)|0.8|STANDARD_ERROR_OF_MEAN|1.0||0.4|TWO_SIDED|||||A priori threshold p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.40
71761020|NCT02688777|143023470|SUPERIORITY||Mean Difference (Final Values)|5.7|STANDARD_ERROR_OF_MEAN|3.4||0.12|TWO_SIDED||||||t-test, 2 sided|||||||0.12
71761021|NCT02688777|143023471|SUPERIORITY||Mean Difference (Final Values)|0.03|STANDARD_ERROR_OF_MEAN|1.1||0.43|TWO_SIDED|||||A priori threshold set at p \< 0.05 for statistical significance.|t-test, 2 sided|||||||0.43
71761022|NCT02688777|143023472|SUPERIORITY||Mean Difference (Final Values)|2.2|STANDARD_ERROR_OF_MEAN|0.8||0.02|TWO_SIDED|||||A prior threshold for significance set at p \< 0.05|t-test, 2 sided|||||||0.02
71761023|NCT02688777|143023473|SUPERIORITY||Mean Difference (Final Values)|13.95|STANDARD_ERROR_OF_MEAN|8.9||0.28|TWO_SIDED||||||t-test, 2 sided|||||||0.28
71761024|NCT02688777|143023474|SUPERIORITY||Mean Difference (Final Values)|0.04||||0.22|TWO_SIDED||||||t-test, 2 sided|||||||0.22
71761025|NCT02688777|143023475|SUPERIORITY|||||||0.1|||||||t-test, 2 sided|||||||0.10
71761026|NCT02688777|143023476|SUPERIORITY|||||||0.09|||||||t-test, 2 sided|||||||0.09
71761027|NCT02688777|143023477|SUPERIORITY|||||||0.11|||||||t-test, 2 sided|||||||0.11
71761028|NCT02688777|143023478|SUPERIORITY|||||||0.28|||||||t-test, 2 sided|||||||0.28
71761029|NCT02549365|143023479|OTHER||Odds Ratio (OR)|2.89|||||TWO_SIDED|95.0|0.6|13.9|||||Incidence of laboratory confirmed influenza is compared between those vaccinated and household controls. VE will be calculated as 1 - RR with 95% confidence intervals using Poisson regression.|||13.9|0.6|
71761030|NCT00531661|143023507|SUPERIORITY_OR_OTHER|||||||0.0002||95.0|||||Negative Binomial Regression|||||||0.0002
71761031|NCT00531661|143023508|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
71761032|NCT00531661|143023509|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
71761033|NCT00531661|143023510|SUPERIORITY_OR_OTHER|||||||0.0077||95.0|||||ANCOVA|||||||0.0077
71761034|NCT00531661|143023511|SUPERIORITY_OR_OTHER|||||||0.0292||95.0|||||Fisher Exact|||||||0.0292
71761035|NCT00531661|143023512|SUPERIORITY_OR_OTHER|||||||0.028||95.0|||||Wilcoxon (Mann-Whitney)|||||||0.0280
71761036|NCT00531661|143023513|SUPERIORITY_OR_OTHER|||||||0.0236||95.0|||||t-test, 2 sided|||||||0.0236
71761037|NCT00531661|143023514|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||Negative Binomial Regression|||||||<0.0001
71761038|NCT00531661|143023515|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) \> 80%"||||<0.0001
71761039|NCT00531661|143023516|SUPERIORITY_OR_OTHER||||||<|0.0001||95.0|||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) \> 90%"||||<0.0001
71761040|NCT01301027|143023541|SUPERIORITY_OR_OTHER|||||||0.047|||||||t-test, 2 sided|||||||0.047
71761041|NCT01301027|143023542|SUPERIORITY_OR_OTHER|||||||0.059|||||||t-test, 2 sided|||||||0.059
71761042|NCT01301027|143023543|SUPERIORITY_OR_OTHER|||||||0.508|||||||t-test, 2 sided|||||||0.508
71761043|NCT01301027|143023544|SUPERIORITY_OR_OTHER|||||||0.984|||||||t-test, 2 sided|||||||0.984
71761044|NCT01009619|143023547|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
71761045|NCT01009619|143023548|SUPERIORITY_OR_OTHER||||||<|0.05||95.0|||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.||||<0.05
71761046|NCT04939415|143023566|SUPERIORITY||ratio of frequencies|0.0||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
71761047|NCT04939415|143023567|SUPERIORITY||ratio of frequencies|1.023||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
71761048|NCT04939415|143023569|SUPERIORITY||ratio of frequencies|1.073||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
71761049|NCT04939415|143023570|SUPERIORITY||ratio of frequencies|2.1||||0.488|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.488
71761050|NCT04939415|143023572|SUPERIORITY||ratio of frequencies|3.243||||0.231|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.231
71761051|NCT04939415|143023573|SUPERIORITY||ratio of frequencies|0.034||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
71761052|NCT04939415|143023574|OTHER||ratio of frequencies|0.083||||1|TWO_SIDED||||||Chi-squared, Corrected|The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.||||||1.000
71761053|NCT04939415|143023576|SUPERIORITY||ratio of frequencies|1.213||||0.462|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||0.462
71761054|NCT04939415|143023577|SUPERIORITY||ratio of frequencies|0.153||||1|TWO_SIDED||||||Chi-squared, Corrected||The Chi-square metric represents the difference between the expected and observed frequencies of an event, therefore it is the ratio of frequencies.|||||1.000
71761055|NCT04939415|143023578|SUPERIORITY||F value|0.185||||0.668|TWO_SIDED||||||Mixed Models Analysis|Group by Day interaction||||||0.668
71761056|NCT04939415|143023579|SUPERIORITY||F value|0.032||||0.86|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.860
71761057|NCT04939415|143023580|SUPERIORITY||F value|0.035||||0.853|TWO_SIDED||||||Mixed Models Analysis||Group by Day interaction|||||0.853
71761058|NCT04939415|143023581|SUPERIORITY||F value|0.0||||0.995|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.995
71761059|NCT04939415|143023582|SUPERIORITY||F value|1.27||||0.266|TWO_SIDED||||||Mixed Models Analysis|||||||0.266
71761060|NCT04939415|143023583|SUPERIORITY||F value|4.533||||0.039|TWO_SIDED||||||Mixed Models Analysis||group by day interaction is reported.|||||0.039
71761061|NCT04939415|143023583|SUPERIORITY||F Ratio|13.897|||<|0.001|TWO_SIDED||||||ANOVA|Degrees of freedom: 1,23||day 0 to day 14 for the mQFPD group were examined.||||<0.001
71761062|NCT04939415|143023583|SUPERIORITY||F ratio|0.41||||0.529|TWO_SIDED||||||ANOVA|degrees of freedom: 1,20||day 0 to day 14 for the Placebo Group were examined.||||0.529
71761063|NCT04939415|143023584|SUPERIORITY||ratio of frequencies|0.14||||0.71|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.710
71761064|NCT04939415|143023585|SUPERIORITY||F value|2.855||||0.099|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.099
71761065|NCT04939415|143023586|SUPERIORITY||F value|1.497||||0.228|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.228
71761066|NCT04939415|143023587|SUPERIORITY||F value|2.537||||0.119|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.119
71761067|NCT04939415|143023588|SUPERIORITY||F value|0.219||||0.643|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.643
71761068|NCT04939415|143023589|SUPERIORITY||F value|0.054||||0.817|TWO_SIDED||||||Mixed Models Analysis|||||||0.817
71761069|NCT04939415|143023590|SUPERIORITY||F value|0.315||||0.578|TWO_SIDED||||||Mixed Models Analysis||group by day interaction|||||0.578
71761070|NCT04939415|143023591|SUPERIORITY||F value|0.215||||0.643|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.643
71761071|NCT04939415|143023592|SUPERIORITY||F value|1.987||||0.159|TWO_SIDED||||||Mixed Models Analysis||day by group interaction|||||.159
71761072|NCT01931566|143023598|OTHER|||||||0.023|||||||Regression, Cox|||||||0.023
71761073|NCT01931566|143023599|SUPERIORITY|||||||0.307|||||||Regression, Cox|||||||0.307
71761074|NCT04625101|143023626|SUPERIORITY|||||||0.4326|||||||ANCOVA|||||||0.4326
71761075|NCT02469870|143023655|SUPERIORITY|||||||0.598|||||||ANCOVA|||To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.||||.598
